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Gravity
Terms in this set (286)
CALCULATIONS
CALCULATIONS
A patient is taking 2 calcium carbonate tablets once daily. Each weighs 1,500 mg total (non-elemental) weight. She wishes to trade her calcium tablets for the citrate form. How many 750 mg citrate tablets (by weight) will she need to provide the same daily dose? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE tablet.)
8
(Pg 76)
A pharmacist dissolves 4 ketoconazole tablets, each containing 200 mg, into a ointment liquid base to prepare 45 mL of a topical solution. What is the percentage strength (w/v) of ketoconazole in the prescription? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round final answer to the nearest TENTH.)
1.8
pg 19
Using the total energy expenditure (TEE) equation, calculate the total non-protein caloric requirement for a patient with third degree burns on 50% of his body (stress factor 1.7). The patient is a 58 year old male who weighs 190 pounds and measures 5'11" in height. Activity factor is 1.2. The BEE for this patient is 1,764 kcal/day, calculated using the Harris-Benedict equation. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
3599
Pg 49-50
A pharmacist has calculated that a patient requires 30 mmol of phosphate and 80 mEq of potassium to be added to the PN. How many milliliters of potassium phosphate and how many milliliters of potassium chloride will be required? [K-Phos is 3 mmol Phosphate with 4.4 mEq K per mL and KCl is 2 mEq/K per mL.]
Answer
A
5 mL potassium phosphate and 22 mL potassium chloride
B
15 mL potassium phosphate and 14 mL potassium chloride
C
10 mL potassium phosphate and 18 mL potassium chloride
D
11 mL potassium phosphate and 6 mL potassium chloride
E
18 mL potassium phosphate and 11 mL potassium chloride
C
Pg 58
Richard Steinberg is admitted to the hospital. His medication orders are as follows:
Demographics/Vitals:
Age: 73 Weight: 185 lbs
BP: 145/92 mmHg HR: 72 BPM
Medication Orders:
2/16
Norvasc 10 mg PO daily
D5 1/2NS +
20 mEq KCl at 50 ml/hr
Protonix 40 mg daily
Lovenox 40 mg daily
Atenolol 100 mg PO daily
2/17
D/C IV fluid from 2/16
Potassium chloride 20 mEq PO BID
Norvasc 10 mg PO daily
D5 1/2NS at 50 ml/hr
Protonix 40 mg daily
Lovenox 40 mg daily
Atenolol 100 mg PO daily
2/18:
D/C IV fluid from 2/17
D/C KCl PO
NS 1 liter +
7 mEq Ca gluconate at 40 mL/hr
Norvasc 10 mg PO daily
Protonix 40 mg daily
Lovenox 40 mg daily
Atenolol 100 mg PO daily
Question:
On February 16th, Mr. Steinberg was off the floor for procedures and tests most of the morning and his 1 liter bag of IV fluid + KCl was not started until 1300. The physician wants the patient to receive the entire 20 mEq of potassium today. What rate (mL/hr) should the fluid be run at to ensure that Mr. Steinberg gets 20 mEq of potassium on February 16th and his 1 liter bag does not run out before midnight? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
91
By the time the 1 liter bag is hung at 1300, there are 11 hours left in the day: 1,000 mL / 11 hours = 90.909 mL/hr (round to 91 mL/hr per instructions). Potassium chloride is a high-risk medication. Always verify that a safe concentration and rate are being infused based on the type of line available and clinical status of the patient.
A pharmacist needs to meet 736 calories using 20% lipids. How many mL are required? (Answer must be numeric; no units or commas.)
368
Pg 55
The total energy expenditure (TEE) using nonprotein calories for a patient is 2,645 kcal/day. The patient is receiving 1,526 kcal from dextrose and 890 kcal from protein. How many kcal should be provided by the lipids? (Answer must be numeric; no units or commas.)
1119
Pg 55
Martin Syde is a 73 year-old male who weighs 205 pounds. What is his CrCl using the Cockcroft-Gault equation? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
Labs:
Na (mEq/L) = 140 (135 - 145)
K (mEq/L) = 4.5 (3.5 - 5)
Cl (mEq/L) = 101 (95 - 103)
HCO3 (mEq/L) = 25 (24 - 30)
BUN (mg/dL) = 20 (7 - 20)
SCr (mg/dL) = 1.4 (0.6 - 1.3)
Glucose (mg/dL) = 122 (100 - 125)
Ca (mg/dL) = 8.9 (8.5 - 10.5)
Mg (mEq/L) = 2.1 (1.3 - 2.1)
PO4 (mg/dL) = 3.1 (2.3 - 4.7)
A1C (%) = 9.8
INR = 0.9 (0 - 1.2)
62
Pg. 41
Since the patient's height is not provided in the case, the only weight available to use in the Cockcroft-Gault equation is the patient's total body weight.
After compounding a PN formula, the pharmacist notes that the solution is hazy and there is a precipitate visible when the bag is agitated. The precipitate is most likely to be which of the following?
Answer
A
KCl
B
NaPO4
C
MgCl
D
CaPO4
E
NaCl
D
g. 59
How many milligrams of sodium thiosulfate (M.W. = 158) are represented by 0.25 mmol? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round final answer to the nearest TENTH.)
39.5
Pg. 35
How many milliliters (mL) of Mylanta suspension are contained in each dose of prescription below?
Belladonna Tincture 30 mL
Phenobarbital 70 mL
Mylanta susp. qs. ad 200 mL
Sig 20 mL BID
Answer
A
2.5 mL Mylanta per dose
B
5 mL Mylanta per dose
C
10 mL Mylanta per dose
D
20 mL Mylanta per dose
E
40 mL Mylanta per dose
C
Pg. 13
A reconstituted solution containing 500 mg of ganciclovir in 20 mL of sterile water for injection is added to 500 mL of 5% dextrose in water. The infusion is to be administered over 2 hours. If the infusion set delivers 15 drops/mL, what should the flow rate be to administer the bag over the designated time interval?
65
pg. 67
A hospital pharmacist receives a prescription for 3% saline for a patient in the Neuro ICU. The premixed 3% saline bags that the pharmacy normally stocks are on backorder. How many milliliters of 23.4% NaCl will need to be added to a 1 liter bag of normal saline to prepare 3% saline for this patient? (MW of Na = 23; MW of Cl = 35.5). (Answer must be numeric; no units or commas; round final answer to the nearest TENTH.)
102.9
pg. 29
Richard Steinberg is admitted to the hospital. His medication orders are as follows:
Demographics/Vitals:
Age: 73 Weight: 185 lbs
BP: 145/92 mmHg HR: 72 BPM
Medication Orders:
2/16
Norvasc 10 mg PO daily
D5 1/2NS +
20 mEq KCl at 50 ml/hr
Protonix 40 mg daily
Lovenox 40 mg daily
Atenolol 100 mg PO daily
2/17
D/C IV fluid from 2/16
Potassium chloride 20 mEq PO BID
Norvasc 10 mg PO daily
D5 1/2NS at 50 ml/hr
Protonix 40 mg daily
Lovenox 40 mg daily
Atenolol 100 mg PO daily
2/18:
D/C IV fluid from 2/17
D/C KCl PO
NS 1 liter +
7 mEq Ca gluconate at 40 mL/hr
Norvasc 10 mg PO daily
Protonix 40 mg daily
Lovenox 40 mg daily
Atenolol 100 mg PO daily
Question:
The pharmacist has 10% calcium gluconate vials that are labeled to contain 0.465 mEq/mL. How many milliliters of calcium gluconate are required to prepare the fluid ordered on February 18th? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
15
The order calls for 7 mEq of calcium gluconate. 7 mEq x 1 mL / 0.465 mEq = 15 mL of 10% calcium gluconate is needed.
A weak acid with a pKa of 8 is added to a solution with a pH of 9. Choose the correct statement:
Answer
A
The compound will be 100% ionized.
B
The compound will be >50% ionized.
C
The compound will be >50% unionized.
D
The compound will be 100% unionized.
E
The compound will be 50% ionized and 50% unionized.
B
Pg. 72-73
Oral potassium chloride 10% solution contains 20 mEq of potassium per 15 mL of solution. A patient is prescribed 22 mEq of potassium daily. How many milliliters of potassium chloride 10% will the patient receive each day? (Answer must be numeric; no units or commas.)
16.5
pg. 36-37
Using the Harris-Benedict equation below, calculate the resting non-protein caloric requirement (BEE) for a major trauma patient (stress factor 1.8). The patient is a 58 year old male who weighs 190 pounds and measures 5'11" in height. Activity factor is 1.2. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
BEE (males): 66.47 + 13.75(weight in kg) + 5.0(height in cm) - 6.76(age in years)
BEE (females): 655.1 + 9.6(weight in kg) + 1.85(height in cm) - 4.68(age in years)
1764
p. 49-50
JM is a patient in the ICU (6'1" and 256 pounds). He is currently receiving a 3-in-1 PN at 115 mL/hr. The PN is 12.1% w/v dextrose and 4.7% w/v protein.
The prescriber wants the patient's protein intake from the PN to be 1.2 g/kg IBW per day. By how many grams will the current protein content need to be reduced to achieve this? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
34
The patient is currently receiving 129.72 g of protein from the PN. The prescriber is requesting 95.88 g (based on IBW). 129.72 g - 95.88 g = 33.84 g (round to 34 g per instructions).
Which of the following represent additional items that may be added to a patient's total parenteral nutrition? (Select ALL that apply.)
Answer
A
Multivitamins
B
Trace elements
C
Insulin
D
Electolytes
E
Dopamine
A, B, C, D
Multivitamins, trace elements, electrolytes and insulin are all items that may be added to a patient's PN.
Using 10 grams of a 15% boric acid ointment, the pharmacist will manufacture a 12% ointment. How many milligrams of diluent is required? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
2500
P. 25
The pharmacist has an order for heparin 25,000 units in 250 mL D5W to infuse at 2,000 units/hour. The infusion set delivers 60 drops per milliliter. How many drops does the patient receive in one hour? (Answer must be numeric; no units or commas.)
1200
P.67
A patient weighing 120 kg is to receive 0.3 mg/kg per day of amphotericin B (reconstituted and diluted to a concentration of 0.1 mg/mL) by IV infusion. What volume of solution is required to deliver the daily dose? (Answer must be numeric; no units or commas.)
360
P. 69
A patient has the following differential:
WBC = 2.2 X 10^3 cells/mm3
Segs = 18%
Bands = 20%
Calculate the ANC. (Answer must be numeric; no units or commas.)
836
P.76-77
Calculate the anion gap for a patient with the following lab values: (Answer must be numeric; no units or commas.)
Labs:
Na (mEq/L) = 130 (135 - 145)
K (mEq/L) = 4.0 (3.5 - 5)
Cl (mEq/L) = 105 (95 - 103)
HCO3 (mEq/L) = 22 (24 - 30)
BUN (mg/dL) = 22 (7 - 20)
SCr (mg/dL) = 1.6 (0.6 - 1.3)
Glucose (mg/dL) = 98 (100 - 125)
Ca (mg/dL) = 10.1 (8.5 - 10.5)
Mg (mEq/L) = 1.9 (1.3 - 2.1)
PO4 (mg/dL) = 3.4 (2.3 - 4.7)
WBC (cells/mm3) =
3.1 (4 - 11 x 10^3)
Hgb (g/dL) =
14.5 (13.5 - 18 male)
Hct (%) =
43.4 (38 - 50 male)
Plt (cells/mm3) =
342 (150 - 450 x 10^3)
Segs = 32%
Bands = 7%
3
P.72
The pharmacist has an order for heparin 25,000 units in 250 mL D5W to infuse at 2,000 units/hour. What is the infusion rate in mL/hour? (Answer must be numeric; no units or commas.)
20
P. 65-66
Greg is a 66 yo male admitted the hospital for cellulitis. What is his CrCl using the Cockcroft-Gault equation? Use ideal body weight. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
Physical Exam / Vitals:
Height: 73 inches Weight: 187 pounds
BP: 167/82 mmHg HR: 79 BPM
RR: 14 BPM Temp: 101.9Â°F Pain: 4/10
Extremities: Mild-moderate right lower extremity cellulitis extending to mid-calf. No open lesions.
Labs:
Na (mEq/L) = 146 (135 - 145)
K (mEq/L) = 5.2 (3.5 - 5)
Cl (mEq/L) = 99 (95 - 103)
HCO3 (mEq/L) = 28 (24 - 30)
BUN (mg/dL) = 22 (7 - 20)
SCr (mg/dL) = 1.7 (0.6 - 1.3)
Glucose (mg/dL) = 137 (100 - 125)
Ca (mg/dL) = 9.5 (8.5 - 10.5)
Mg (mEq/L) = 1.9 (1.3 - 2.1)
PO4 (mg/dL) = 3.0 (2.3 - 4.7)
48
P.41
An obese female patient is to receive 4.6 mg/kg/d of theophylline, dosed on IBW. The patient is 5'4" and weighs 245 pounds. Calculate the patient's daily dose of theophylline. (Answer must be numeric; no units or commas; round final answer to the nearest TEN milligrams.)
250
P.39
Gretta is a 42 yo female who weighs 185 pounds and is 65 inches tall. Her Scr is 1.8. What is her CrCl using the Cockcroft-Gault equation? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
44
P.41
A 31 year old female is recovering in the surgical intensive care unit post major surgery. The medical team wants to start PN. She is 116 pounds, 5' 6" with some mild renal impairment. Calculate her BEE using the Harris-Benedict equation provided. (stress factor = 1.7 and activity factor =1.2). (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
BEE (males): 66.47 + 13.75(weight in kg) + 5.0(height in cm) - 6.76(age in years)
BEE (females): 655.1 + 9.6(weight in kg) + 1.85(height in cm) - 4.68(age in years)
1326
P.49-50
The pharmacy receives a prescription for 100 grams of 5% hydrocortisone ointment. You have a 10% hydrocortisone ointment and a 2.5% hydrocortisone ointment available. Using only these products, how many grams of the 2.5% ointment should be used to compound this prescription? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round final answer to the nearest TENTH.)
66.7
P. 26-27
How many milliequivalents of sodium are in 1 mL of 8.4% sodium bicarbonate? (M.W. = 84) (Answer must be numeric; no units or commas.)
1
P. 36-37
A 51 year-old male (height 5'9" and weight 175 lbs) is hospitalized after a motor vehicle accident. He develops a Pseudomonas aeruginosa infection. The physician orders tobramycin 1.5 mg/kg IV Q8H. Calculate the tobramycin dose that will be given every 8 hours. Use the patient's IBW. (Answer must be numeric; no units or commas; round final answer to the nearest TEN milligrams.)
110
P. 39
Danielle is a 22 year old female (154 pounds) in the ICU after a motor vehicle accident. She is going to be started on PN today. The prescriber has ordered 25 kcal/kg/day to be provided as a 2-in-1 PN solution with standard electrolytes. The pharmacist has several bags of 2-in-1 PN with standard electrolytes that were ordered for a different patient whose PN was actually discontinued yesterday. The PN bags are labeled D20% (w/v) and amino acid 7% (w/v). How many milliliters of this PN would be required to provide the daily caloric intake ordered for Danielle? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
1823
The available PN provides the following: 0.68 kcal/ml of dextrose (20 g/100 mL = x g/1 mL; 0.2 g/ 1 ml x 3.4 kcal/g) and 0.28 kcal/mL of amino acid (7 g/100 mL = x g/1 mL; 0.07 g/1 mL x 4 kcal/g). Adding these together (0.68 kcal/mL + 0.28 kcal/mL), the PN provides 0.96 kcal/mL. The patient needs 1750 kcals/day. 1750 kcal/day x 1 mL/0.96 kcal = 1822.9 mL (rounded to 1823 per instructions).
An order is written for cyclosporine 5 mg/kg IV. How many milliliters of a 50 mL bag containing 100 mg of cyclosporine per milliliter should be administered to a 165 pound liver transplant patient? (Answer must be numeric; no units or commas.)
3.75
P. 69
A nurse is hanging a 2% lidocaine solution for a patient. If the dose is 4 mg/min, how many hours will a 100 mL bag last? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
8
P. 67
The pharmacist has an order for heparin 25,000 units in 250 mL D5W to infuse at 2,000 units/hour. How many hours will be needed to infuse the entire bag? (Answer must be numeric; no units or commas.)
12.5
P. 65-66
Calculate the body mass index (BMI) for a male who is 6'4" tall and weighs 225 pounds. (Answer must be numeric; no units or commas; round final answer to the nearest TENTH.)
27.4
P. 38
A 10 mL vial is labeled potassium chloride (2 mEq/mL). How many grams of potassium chloride are present? (M.W. of KCl = 74.5) (Answer must be numeric; no units or commas; include a leading zero if answer is less than 1.)
1.49
P. 36-37
A babysitter brings a 9-year-old girl to the Emergency Department. She is unarousable. Labs are ordered and an ABG is drawn. The ABG results are as follows: 7.49/42/85/39/96. What acid base disorder does the child have?
Answer
A
Metabolic acidosis
B
Metabolic alkalosis
C
Respiratory acidosis
D
Respiratory alkalosis
B
P. 71
The pharmacist has an order for heparin 25,000 units in 250 mL D5W to infuse at 2,000 units/hour. How many units of heparin will the patient receive in 10 hours? (Answer must be numeric; no units or commas.)
20,000
PG. 69
A patient has been receiving 500 mL of an enteral mixture that contains 645 mOsm/L. The pharmacist will reduce the contents to 480 mOsm/L. How many milliliters of bacteriostatic water should be added to the bag? Round to the nearest WHOLE number.
Answer
A
150 mL
B
172 mL
C
500 mL
D
645 mL
E
672 mL
B
P. 25-26
Pete is 71 inches tall and weighs 392 pounds. What is his adjusted body weight in kilograms? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
116
P. 39
A pharmacist adds 250 mg of drug A to 500 mL of 0.9% Sodium Chloride. If the solution is administered at 1.6 mL per minute, how many milligrams of drug A will the patient receive in 1 hour? (Answer must be numeric; no units or commas.)
48
P. 69
Using 10 grams of a 15% boric acid ointment, the pharmacist will manufacture an 8% ointment. How many grams of diluent is required? (Answer must be numeric; no units or commas; round final answer to the nearest TENTH.)
8.8
P. 25
A patient is taking 2 calcium citrate tablets once daily. Each weighs 1,500 mg total (non-elemental) weight. She wishes to trade her calcium tablets for the carbonate form. How many 800 mg carbonate tablets (by weight) will she need to provide the same daily dose? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE tablet.)
2
P. 76
Polly is 62 inches tall and weighs 225 lbs. What is her adjusted body weight? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
71
P. 39
Calculate the corrected calcium for a patient with the following lab values. (Answer must be numeric; no units or commas; round final answer to the nearest TENTH.)
Labs:
Na (mEq/L) = 135 (135 - 145)
K (mEq/L) = 3.6 (3.5 - 5)
Cl (mEq/L) = 101 (95 - 103)
HCO3 (mEq/L) = 25 (24 - 30)
BUN (mg/dL) = 13 (7 - 20)
SCr (mg/dL) = 1.0 (0.6 - 1.3)
Glucose (mg/dL) = 95 (100 - 125)
Ca (mg/dL) = 7.8 (8.5 - 10.5)
Mg (mEq/L) = 1.5 (1.3 - 2.1)
PO4 (mg/dL) = 2.3 (2.3 - 4.7)
WBC (cells/mm3) =
6.2 (4 - 11 x 10^3)
Hgb (g/dL) =
14.5 (12 - 16 female)
Hct (%) =
43.4 (36 - 46 female)
Plt (cells/mm3) =
342 (150 - 450 x 10^3)
Albumin (g/dL) = 2.2 (3.5 - 5)
AST (IU/L) = 25 (10 - 40)
ALT (IU/L) = 12 (10 - 40)
9.2
P. 58-59
A 10 gram packet of potassium chloride provides 20 mEq of potassium. How many grams of powder would provide 9 mEq of potassium? (Answer must be numeric; no units or commas.)
4.5
P. 36-37
A pharmacist has an order for parenteral nutrition that includes 1000 mL of D70%. The pharmacist checks the supplies and finds the closest strength available is D50%. How many mL of D50% will provide an equivalent energy requirement? Round to the nearest WHOLE number.
Answer
A
500 mL
B
1000 mL
C
1400 mL
D
1500 mL
E
1700 mL
P. 25
How many milliliters (mL) of Mylanta suspension are contained in each dose of prescription below? Round to the nearest WHOLE number.
Belladonna Tincture 20 mL
Phenobarbital 80 mL
Mylanta susp. qs. ad 150 mL
Sig 15 mL TID
Answer
A
2.5 mL Mylanta per dose
B
5 mL Mylanta per dose
C
10 mL Mylanta per dose
D
15 mL Mylanta per dose
E
45 mL Mylanta per dose
B
P. 13
You are asked to prepare one liter of 10% sodium bicarbonate solution. You only have a 1% solution and a 20% solution in stock. How many milliliters of the 1% solution will be required to compound this prescription? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
526
P. 26-27
If 1 gallon of a 15% (w/v) solution is evaporated to a solution with a 40% (w/v) strength, what will be the new volume (in milliliters)? Use 1 gallon = 3,785 mL. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
1419
P. 25
You are asked to prepare one liter of 10% NaCl solution for irrigation. You only have a 0.9% solution and a 23.4% solution in stock. Using both the high and the low concentration, how many milliliters of the 23.4% solution will be required to compound this prescription? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
404
P. 28
Calculate the corrected calcium for a patient with the following lab values. (Answer must be numeric; no units or commas; round final answer to the nearest TENTH.)
Labs:
WBC (cells/mm3) =
10.2 (4 - 11 x 10^3)
Hgb (g/dL) =
13.3 (13.5 - 18 male)
Hct (%) =
38.2 (38 - 50 male)
Plt (cells/mm3) =
342 (150 - 450 x 10^3)
Albumin (g/dL) = 1.7 (3.5 - 5)
AST (IU/L) = 56 (10 - 40)
ALT (IU/L) = 42 (10 - 40)
A1C (%) = 8.5
Na (mEq/L) = 142 (135 - 145)
K (mEq/L) = 3.5 (3.5 - 5)
Cl (mEq/L) = 101 (95 - 103)
HCO3 (mEq/L) = 25 (24 - 30)
BUN (mg/dL) = 13 (7 - 20)
SCr (mg/dL) = 1.5 (0.6 - 1.3)
Glucose (mg/dL) = 129 (100 - 125)
Ca (mg/dL) = 8.1 (8.5 - 10.5)
Mg (mEq/L) = 1.1 (1.3 - 2.1)
PO4 (mg/dL) = 4.8 (2.3 - 4.7)
9.9
P. 58-59
A parent brings a 6-year-old boy to the Emergency Department. Labs are ordered and an ABG is drawn. The ABG results are as follows: 7.24/53/99/26/98. What acid base disorder does the child have?
Answer
A
Metabolic acidosis
B
Metabolic alkalosis
C
Respiratory acidosis
D
Respiratory alkalosis
C
P.71
Choose the correct statement concerning parenteral nutrition (PN) therapy:
Answer
A
Dextrose in PN provides 1.1 kcal/gram
B
Amino acids provide 4 kcal/gram
C
Dextrose in PN provides 4 kcal/gram
D
20% fat emulsion provides 2.2 kcal/gram
E
10% fat emulsion provides 2.2 kcal/gram
B
Amino acids provide 4 kcal/gram; dextrose provides 3.4 kcal/gram.
Calculate the body mass index (BMI) for a female who is 5'4" tall and weighs 180 pounds. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
31
P. 38
Calculate the anion gap for a patient with the following lab values: (Answer must be numeric; no units or commas.)
Labs:
WBC (cells/mm3) =
2.3 (4 - 11 x 10^3)
Hgb (g/dL) =
14.5 (12 - 16 female)
Hct (%) =
43.4 (36 - 46 female)
Plt (cells/mm3) =
342 (150 - 450 x 10^3)
PMNs = 32%
Bands = 5%
Na (mEq/L) = 132 (135 - 145)
K (mEq/L) = 4.0 (3.5 - 5)
Cl (mEq/L) = 100 (95 - 103)
HCO3 (mEq/L) = 18 (24 - 30)
BUN (mg/dL) = 18 (7 - 20)
SCr (mg/dL) = 1.4 (0.6 - 1.3)
Glucose (mg/dL) = 276 (100 - 125)
Ca (mg/dL) = 9.8 (8.5 - 10.5)
Mg (mEq/L) = 1.3 (1.3 - 2.1)
PO4 (mg/dL) = 4.2 (2.3 - 4.7)
14
P.72
A patient has the following differential:
WBC = 6,200 cells/mm3
Segs = 14%
Bands = 7%
Calculate the ANC. (Answer must be numeric; no units or commas.)
1302
P. 76-77
Phosphate and calcium can precipitate in a PN bag and cause a pulmonary embolus. Which of the following methods can help reduce this risk?
Answer
A
Keeping the pH above 6
B
Choosing calcium chloride over calcium gluconate
C
The calcium and phosphate added together should not exceed 45 mEq/L
D
Keeping the calcium:phosphorus ratio less than 1:2
E
Infusing the PN within four days of preparation
C
The calcium and phosphate in a PN should not exceed 45 mEq/L. An excess can precipitate and lead to a pulmonary embolus.
Janine is a 73 yo female who weighs 102 pounds and is 63 inches tall. Her SCr is 1.5. What is her CrCl using the Cockcroft-Gault equation? Use actual weight. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
24
P. 41
A pharmacist receives an order for voriconazole 6 mg/kg IVPB Q12H for 24 hours for a patient weighing 150 lbs. How many total milligrams (mg) of voriconazole will the patient receive? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
818
P. 69
A patient has a blood urea nitrogen (BUN) of 38 and a serum creatinine of 2.4. Is the patient dehydrated?
Answer
A
It is not possible to estimate dehydration with these lab parameters.
B
Yes, a BUN:SCr ratio less than 20:1 indicates dehydration.
C
No, not until the BUN:SCr ratio is greater than 20:1.
D
No, not until the ratio is greater than 40:1.
E
No, not until the ratio is greater than 80:1.
C
A patient with a BUN/SCr ratio greater than 20:1 can be considered dehydrated.
If 500 mL of a 28% (v/v) solution of methyl salicylate are diluted to a 2 liter solution, what will be the percentage strength (v/v)? (Answer must be numeric; no units or commas.)
7
P. 25
Choose the correct indications for parenteral nutrition (PN) therapy. (Select ALL that apply.)
Answer
A
Severe gut dysfunction due to various conditions, such as Crohn's disease, ulcerative colitis, obstruction and short bowel syndrome from surgery.
B
Patients requiring long-term supplemental nutrition because they are unable to receive daily requirements through oral or enteral feedings.
C
A patient who will be NPO for three full days secondary to surgery.
D
All patients in the ICU.
E
A patient with mild acute pancreatitis.
A, B
PN indications include severe gut dysfunction due to various conditions and patients requiring long-term supplemental nutrition because they are unable to receive daily requirements through oral or enteral feedings.
The pharmacy receives the following PN order. What percentage of the total calories are represented by the protein component? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
Item/Quantities:
Dextrose 270 g
Amino acids 60 g
Sodium chloride 38 mEq
Sodium acetate 16 mEq
Potassium 40 mEq
Magnesium sulfate 10 mEq
Phosphate 21 mmol
Calcium 4.45 mEq
MVI-12 5 mL
Trace elements 1 mL
Vitamin K-1 0.5 mg
Famotidine 10 mg
Regular insulin 40 units
Sterile water qs ad 980 mL
21
P. 62
The Cockcroft-Gault equation is commonly used by pharmacists to estimate renal clearance. This equation takes into consideration each of the following parameters except:
Answer
A
Age
B
Height
C
Weight
D
Sex
E
Serum creatinine
B
P. 41
What is the osmolarity, in mOsm/L, of 3% NaCl? (M.W. = 58.5). (Answer must be numeric; no units or commas; round final answer to the nearest whole number.)
1026
P. 30
A patient is to receive 10 mEq of calcium. The pharmacy has calcium gluconate 10% in stock, which contains 0.465 mEq/mL of calcium. How many milliliters of calcium gluconate are required? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
22
P. 60
The pharmacy receives the following PN order. How many milliliters of potassium phosphate (each mL contains 3 mmol of phosphate and 4.4 mEq of potassium) should be added to the PN to fulfill the phosphate requirements? (Answer must be numeric; no units or commas.)
Item/Quantities:
Dextrose 270 g
Amino acids 60 g
Sodium chloride 38 mEq
Sodium acetate 16 mEq
Potassium 40 mEq
Magnesium sulfate 10 mEq
Phosphate 21 mmol
Calcium 4.45 mEq
MVI-12 5 mL
Trace elements 1 mL
Vitamin K-1 0.5 mg
Famotidine 10 mg
Regular insulin 40 units
Sterile water qs ad 980 mL
7
P. 61
The pharmacy receives the following PN order. Calculate the mL of dextrose 70% that should be added to the PN. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
Item/Quantities:
Dextrose 270 g
Amino acids 60 g
Sodium chloride 38 mEq
Sodium acetate 16 mEq
Potassium 40 mEq
Magnesium sulfate 10 mEq
Phosphate 21 mmol
Calcium 4.45 mEq
MVI-12 5 mL
Trace elements 1 mL
Vitamin K-1 0.5 mg
Famotidine 10 mg
Regular insulin 40 units
Sterile water qs ad 980 mL
386
P. 54
How many milligrams of NaCl are in a 10 mL vial of NS? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
90
P. 17
Which of the following are causes of elevated anion gap metabolic acidosis? (Select ALL that apply.)
Answer
A
Diabetic ketoacidosis
B
Salicylate toxicity
C
Opioid intoxication
D
Diarrhea
E
Lactic acidosis
A, B E
P. 72
Vicki is a 37 year old female who is receiving 334 grams of dextrose, 87 grams of amino acids, and 310 mL of 10% lipids via her PN therapy. What percentage of calories is provided by the protein content? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
19
P. 62
How many calories are provided by 275 mL of 50% dextrose in water? (Answer must be numeric; no units or commas; round final answer to the nearest TENTH.)
467.5
P. 54
Carl, a 63 year old male, is receiving 1,150 mL of D30W, 860 mL of Aminosyn 8.5%, and 340 mL of Intralipid 10% in his PN therapy. What percentage of the non-protein calories are represented by dextrose? (Answer must be numeric; no units or commas; round to the nearest WHOLE number.)
76
P. 53
Using D50W (50% dextrose in water), how many mL are required to fulfuill a PN order for 525 g of dextrose? (Answer must be numeric; no units or commas.)
1050
P. 53
A patient is to receive 11 mEq of calcium. The pharmacy has calcium gluconate 10% in stock which provides 0.465 mEq/mL. How many mL of calcium gluconate should be added to the PN? (Answer must be numeric; no units or commas; round final answer to the nearest TENTH.)
23.7
P. 60
A dexamethasone elixir contains 0.5 mg dexamethasone per 5 mL. What is the percentage strength (w/v) of the dexamethasone elixir in this prescription? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
0.01
P. 19
If a solution contains 20 g of glycerol and 5 g of codeine, what is the glycerol percentage strength (w/w) of the solution? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
80
P. 19
The pharmacy has an order for 10 mL of tobramycin 1% ophthalmic solution. The pharmacy has in stock tobramycin 40 mg/mL solution. Tobramycin has a M.W. of 468 and does not dissociate. NaCl has a M.W. of 58.5 and a dissociation factor of 1.8. What is the equivalent value (the "E value") of tobramycin? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round final answer to two decimal places.)
0.07
P. 32-34
A prescription reads as follows: Prepare lidocaine HCl 3% w/v; qs with pure water to 60 mL. How many grams of lidocaine is required to compound this prescription? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
1.8
P. 17
The pharmacist needs to measure out 35 grams of a 70% powder using the 50% and 90% powders he has in stock. How much of each powder is required?
Answer
A
25 grams of the 50% and 10 grams of the 90%
B
12.5 grams of the 50% and 22.5 grams of the 90%
C
17.5 grams of the 50% and 17.5 grams of the 90%
D
20 grams of the 50% and 15 grams of the 90%
E
22 grams of the 50% and 13 grams of the 90%
C
P. 26-28
An elderly male is hospitalized with sepsis. He is 6 feet tall and 143 pounds. Select the correct BMI for this patient and the corresponding classification:
Answer
A
18.2, underweight
B
19.4, underweight
C
19.4, obese
D
18.2, overweight
E
19.4, normal weight
E
P. 38
How many milligrams of sodium hydroxide (M.W. = 40) are represented by 0.25 mmol? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
10
P. 35
A patient has the following ABG: pH = 7.6, paCO2 = 60, HCO3 = 32 What is the acid-base disorder present in this patient?
Answer
A
Metabolic acidosis
B
Respiratory acidosis
C
Metabolic alkalosis
D
Respiratory alkalosis
E
This is a normal ABG
C
An acid-base disorder that leads to a pH > 7.45 is called an alkalosis. In a metabolic alkalosis, the plasma HCO3 concentration is increased. If both pCO2 and HCO3 are abnormal (meaning some degree of compensation has occurred), the primary disorder is determined by identifying which one corresponds with the pH.
What is the pH of a solution prepared to be 0.4 M ammonia and 0.04 M ammonium chloride (pKb for ammonia = 4.76)? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round final answer to the nearest HUNDREDTH.)
10. 24
P. 73
An 80 year-old male has a severe diabetic foot infection. He will be started on broad spectrum empiric therapy including piperacillin/tazobactam (Zosyn). The recommended renal dose adjustments for Zosyn and the patient's labs/demographic data are provided below. What is the correct starting dose of Zosyn for this patient?
CrCl > 40 mL/min -
Zosyn 3.375 grams IV Q6H
CrCl 20-40 mL/min -
Zosyn 2.25 grams IV Q6H
CrCl < 20 mL/min -
Zosyn 2.25 grams IV Q8H
Physical Exam / Vitals:
Height: 5'3" Weight: 118 pounds
BP: 153/72 mmHg HR: 62 BPM
RR: 14 BPM Temp: 101.3Â°F Pain: 9/10
CV: Regular
Extremities: Severe bilateral lower extremity wounds. Wounds are open with purulent drainage. Two small wounds on left extremity appear to be necrotic.
Labs:
Na (mEq/L) = 137 (135 - 145)
K (mEq/L) = 4.8 (3.5 - 5)
Cl (mEq/L) = 101 (95 - 103)
HCO3 (mEq/L) = 26 (24 - 30)
BUN (mg/dL) = 22 (7 - 20)
SCr (mg/dL) = 1.3 (0.6 - 1.3)
Glucose (mg/dL) = 279 (100 - 125)
Ca (mg/dL) = 9.2 (8.5 - 10.5)
Mg (mEq/L) = 1.5 (1.3 - 2.1)
PO4 (mg/dL) = 2.9 (2.3 - 4.7)
WBC (cells/mm3) =
11.2 (4 - 11 x 10^3)
Hgb (g/dL) =
14.5 (13.5 - 18 male)
Hct (%) =
43.4 (38 - 50 male)
Plt (cells/mm3) =
342 (150 - 450 x 10^3)
AST (IU/L) = 25 (10 - 40)
ALT (IU/L) = 12 (10 - 40)
Albumin (g/dL) = 3.9 (3.5 - 5)
A1C (%) = 11.8
2.25 grams IV Q6H
P.41-46
The pharmacy receives the following PN order. How many milliliters of sodium acetate 16.4% (2 mEq/mL) should be added to the PN? (Answer must be numeric; no units or commas.)
Item/Quantities:
Dextrose 270 g
Amino acids 60 g
Sodium chloride 38 mEq
Sodium acetate 16 mEq
Potassium 40 mEq
Magnesium sulfate 10 mEq
Phosphate 21 mmol
Calcium 4.45 mEq
MVI-12 5 mL
Trace elements 1 mL
Vitamin K-1 0.5 mg
Famotidine 10 mg
Regular insulin 40 units
Sterile water qs ad 980 mL
8
P. 61
A pharmacist has prepared a PN that contains 600 grams of dextrose. How many calories are provided by the dextrose? (Answer must be numeric; no units or commas.)
2040
P. 47
The "E value" for tobramycin is 0.07. A prescription is received for 10 mL of a 1% tobramycin eye drop solution. How many milligrams of NaCl need to be added to make the eye drop isotonic? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
83
P. 33
The pharmacy receives the following PN order. Calculate the amount of magnesium sulfate (4 mEq/mL) that should be added to the PN. (Answer must be numeric; no units or commas.)
Item/Quantities:
Dextrose 270 g
Amino acids 60 g
Sodium chloride 38 mEq
Sodium acetate 16 mEq
Potassium 40 mEq
Magnesium sulfate 10 mEq
Phosphate 21 mmol
Calcium 4.45 mEq
MVI-12 5 mL
Trace elements 1 mL
Vitamin K-1 0.5 mg
Famotidine 10 mg
Regular insulin 40 units
Sterile water qs ad 980 mL
2.5
P.62
An order is written for 10 mL of a 0.125% bupivacaine injection and 10 mL of morphine injection (1 mg/mL) to be mixed with 250 mL of normal saline. The infusion is to be administered over 3 hours. The IV set delivers 20 drops/mL. What should be the rate of flow in drops/minute to deliver this infusion?
30 drops/minute
P. 67
The pharmacist is going to add 60 mEq of sodium to the PN; half will be given as sodium acetate (2 mEq/mL) and half as sodium chloride (4 mEq/mL). How many milliliters of sodium chloride will be needed? (Answer must be numeric; no units or commas.)
7.5
P. 57-58
A patient has the following ABG: pH = 7.5, paCO2 = 25, HCO3 = 24. What is the acid-base disorder present in this patient?
Answer
A
Metabolic acidosis
B
Respiratory acidosis
C
Metabolic alkalosis
D
Respiratory alkalosis
E
This is a normal ABG
D
An acid-base disorder that leads to a pH > 7.45 it is called an alkalosis. In respiratory alkalosis, the pCO2 is decreased.
A hospital pharmacist receives a prescription for 3% saline for a patient in the Neuro ICU. The premixed 3% saline bags that the pharmacy normally stocks are on backorder. How many milliequivalents of 23.4% NaCl will need to be added to a 1 liter bag of normal saline to prepare 3% saline for this patient? (MW of Na = 23; MW of Cl = 35.5). (Answer must be numeric; no units or commas; round final answer to the nearest TENTH.)
411.8
P. 26, 36
This problem incorporates both concepts. Alligation can be performed in this manner when the final volume is not known. After performing the alligation, it is determined that ~102.94 mL of 23.4% NaCl must be added. Next use the MWs provided to convert to milliequivalents of 23.4% NaCl. Round only the final answer. Hypertonic saline is a high-risk medication associated with numerous medication errors. Use of premixed products is always preferred; compounding should be avoided.
What is the pH of a solution containing 0.2 mole of a weak acid and 1 mole of its salt? (pKa of the acid = 5.35). (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round final answer to the nearest HUNDREDTH.)
6.05
P. 73
What is the percentage strength of neomycin in the following prescription? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
Rx:
Neomycin (5%) cream 30 g
Polymyxin B 20 g
Hydrocortisone 10 g
2.5
P. 20
Which statement best describes this patient's hydration status based on the labs provided below:
Labs:
Na (mEq/L) = 139 (135 - 145)
K (mEq/L) = 3.9 (3.5 - 5)
Cl (mEq/L) = 99 (95 - 103)
HCO3 (mEq/L) = 26 (24 - 30)
BUN (mg/dL) = 67 (7 - 20)
SCr (mg/dL) = 1.7 (0.6 - 1.3)
Glucose (mg/dL) = 128 (100 - 125)
Ca (mg/dL) = 9.9 (8.5 - 10.5)
Mg (mEq/L) = 1.8 (1.3 - 2.1)
PO4 (mg/dL) = 2.6 (2.3 - 4.7)
Answer
A
The patient appears to be well hydrated based on normal values for Na, K, Ca, Mg and PO4.
B
The patient appears to be dehydrated based on the normal values for Na, K, Ca, Mg and PO4.
C
The patient appears to be dehydrated based on the Na:Cl ratio.
D
The patient appears to be well hydrated based on the BUN:SCr ratio.
E
The patient appears to be dehydrated based on the BUN:SCr ratio.
E
P. 40
A patient with a BUN/SCr ratio greater than 20/1 can be considered dehydrated. However many hospitalized patients will have a ratio that indicates mild dehydration (such as 21, or 22). More severe dehydration requires more urgent treatment.
An ear drop contains 18 mg of lidocaine in each milliliter of solution. Calculate the percentage strength (w/v) of lidocaine. (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
1.8
P. 19
The pharmacy receives the following PN order. The PN calls for 21 mmol of phosphate and 4.45 mEq of calcium in a total volume of 980 mL. There are 2 mEq of phosphate/mmol. Calculate the total milliequivalents (mEq) of calcium and phosphorus in the PN. (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
Item/Quantities:
Dextrose 270 g
Amino acids 60 g
Sodium chloride 38 mEq
Sodium acetate 16 mEq
Potassium 40 mEq
Magnesium sulfate 10 mEq
Phosphate 21 mmol
Calcium 4.45 mEq
MVI-12 5 mL
Trace elements 1 mL
Vitamin K-1 0.5 mg
Famotidine 10 mg
Regular insulin 40 units
Sterile water qs ad 980 mL
46
P. 62
One gallon of hand lotion contains 472 mL of cetyl alcohol. What is the percentage (v/v) of cetyl alcohol in the lotion?(Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round final answer to the nearest WHOLE number.)
12
P. 16
A PN contains 7 mL of potassium phosphate (each mL contains 3 mmol of phosphate and 4.4 mEq of potassium). The daily potassium requirement is 42 mEq. How many milliliters of potassium chloride (2 mEq/mL) should be added to the PN? (Answer must be numeric; no units or commas.)
5.6
P. 61
What is the osmolarity, in mOsm/L, of D10W? (M.W. = 198). (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
505
P. 30
A patient requires 400 grams of dextrose in their PN bag. If the pharmacist is using D50W, how many milliliters of D50W will be needed to provide the 400 grams? (Answer must be numeric; no units or commas.)
800
P. 53
A prefilled syringe contains 50 mg of phenylephrine hydrochloride per 5 mL of injection. Express the percentage concentration (w/v) of phenylephrine in the injection. (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
1
P. 19
The pharmacist receives a prescription for "Cefaclor 500 mg #30, Sig: i cap po q 8 hrs ATC." Choose the correct wording for the prescription label.
Answer
A
Take 1 capsule by mouth 8 hours after therapeutic concentration is reached.
B
Take 1 capsule by mouth every 8 hours around the clock.
C
Take 1 capsule by mouth every 8 hours after each meal.
D
Take 1 capsule by mouth every 8 hours after chewing, then swallowing.
E
Insert 1 tablet by mouth 8 hours after the cavity is cleared.
B
P. 11
A pharmacy technician added 10 mL of a 20% (w/v) solution of potassium chloride to a 500 mL bag of normal saline. What is the percentage strength of potassium chloride in the bag? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round final answer to the nearest HUNDREDTH.)
0.39
P. 19
The pharmacist receives a prescription for "Timoptic 0.25%, Sig: i gtt od qam." Choose the correct wording for the prescription label.
Answer
A
Place 1 drop in each eye daily in the morning.
B
Instill 1 drop in the left eye daily in the morning.
C
Place 1 drop in each eye after dinner.
D
Place 1 drop in the right eye daily in the morning.
E
Instill 1 drop in the right eye daily.
D
P. 11
A pharmacist is approached by a physician for help writing a parenteral nutrition order. The patient is currently receiving a 2-in-1 formula consisting of 425 grams of dextrose and 110 grams of protein.
Dietary Progress Note:
"Patient needs 2,400 calories per day. Recommend 10% Intralipid infusion to provide the remaining calories".
Hospital policy is to infuse the daily lipid requirement over 12 hours to reduce infection risk. What rate (mL/hr) should the pharmacist recommend for the Intralipid to provide the necessary calories? (Answer must be numeric; no units or commas; round to the nearest WHOLE number.)
39
P. 54, 64
This problem incorporates both concepts. The current PN provides 1885 kcals, so 515 kcals must be provided by the 10% Intralipid. Be sure to divide the volume of 10% Intralipid by 12 to get the 12-hr infusion rate. In many hospitals, lipids are infused over 8 or 12 hours.
How many grams of NaCl are in 250 mL of NS? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
2.25
P. 16
How many grams of dextrose are in 1,000 mL of D5W? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
50
P. 17
An elderly female is admitted to the hospital after falling down the stairs. She hit her head and is in the ICU. An ABG is obtained and the results are as follows: 7.92/28/96/26/96. What acid base disorder does this patient have?
Answer
A
Metabolic acidosis
B
Metabolic alkalosis
C
Respiratory acidosis
D
Respiratory alkalosis
D
P. 71
An elderly male is admitted to the hospital after a motor vehicle accident. He suffered a head injury and is in the ICU. An ABG is obtained and the results are as follows: 6.89/45/82/19/98. What acid base disorder does this patient have?
Answer
A
Metabolic acidosis
B
Metabolic alkalosis
C
Respiratory acidosis
D
Respiratory alkalosis
A
P. 71
How many moles are equivalent to 290 mg of aluminum hydroxide? (M.W. = 78). (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round final answer to three decimal places.)
0.004
P. 35
Express 0.005% in parts per million (PPM). (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
50
P. 22
How many grains of aspirin will be contained in each capsule?
Rx: Aspirin 15 g Diphenhydramine 1.2 g Lactose 1 g No. 30 caps Sig. One capsule QHS prn sleep.
(Answer must be numeric; no units or commas; round the final answer to the nearest TENTH.)
7.7
P. 15-16
A patient is receiving 650 mL of 10% lipids on Tuesdays and Thursdays. How many calories is the patient receiving from the lipids each week? (Answer must be numeric; no units or commas.)
1430
P. 54
Using a 10% lipid emulsion, how many milliliters (mL) are required to meet 680 calories? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
618
P. 55
How many milliliters (mL) of guaifenesin syrup are contained in each dose of the prescription below? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
Rx:
Phenergan syrup 60 mL
Guaifenesin syrup qs ad 200 mL
Sig. ii tsp PRN cough
7
P. 13
Express 450 parts per million (PPM) as a percentage. (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
0.045
P. 22
How many grams of 2.5% hydrocortisone cream should be mixed with 56 grams of 0.25% hydrocortisone cream to prepare a 1% cream? (Answer must be numeric; no units or commas.)
28
P. 29
Measure out 60 g of a 40% ephedrine sulfate using the 60% and 20% in stock. How much of the 60% and the 20% (in grams) are needed?
30 g of 60%, 30 g of 20%
P. 26-27
What is the ratio strength of 100 mL containing a 1:50 povidone iodine solution diluted to 1000 mL? (Answer must be numeric; no units or commas; do not enter the 1 and the colon; enter only the number after the colon, as shown here with Xs: 1:XXX.)
500
P. 20-21
A patient is receiving 275 mL of 20% lipids. How many calories is the patient receiving from the lipids? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
550
P. 55
Georgia is a 71 year old female admitted to the hospital with bowel obstruction. She will be NPO for at least the next several days and will be starting PN therapy. Georgia weighs 57 kg and is 5'2". Calculate her estimated fluid requirements using the formula 1500 mL + 20 mL(wt in kg - 20). (Answer must be numeric; no units or commas.)
2240
P. 48-49
How many mL of a 1:5000 (w/v) solution of aluminum acetate can be made from 100 mL of a 0.3% solution? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
1500
P. 20-21
If a codeine suspension contains 15 mg of codeine per 5 mL, how many grams of codeine would be used in preparing 240 mL of the suspension? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
0.72
P. 9
The intravenous dose of digoxin is 80% of the oral digoxin dose. If the oral dose is 20 mcg/kg, what is the intravenous dose, in micrograms, for a 6 year old child weighing 50 lbs? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
364
P. 10
The pharmacist needs to add an additional 400 calories to a PN. If the pharmacist is using a 10% lipid emulsion, how many milliliters are required to meet the remaining calories? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
364
P. 55
Phosphoric acid has a specific gravity (SG) of 1.70. How many quarts of phosphoric acid would be needed to compound a prescription that requires 3216 grams of phosphoric acid? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
2
P. 24
Express 1:1500 as a percentage strength. (Answer must be numeric; no units or commas; include a leading zero if answer is less than 1; round the final answer to the nearest THOUSANDTH.)
0.067
P. 20
Tim requires 1.5 g/kg/day of protein (based on his actual body weight) which will be provided by Aminosyn 15%. Tim is a 62 year old male (weight 89 kg, height 6'2") who is confined to bed (activity factor 1.2) due to his current pneumonia infection (stress factor 1.6). How many milliliters of Aminosyn 15% should he receive. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
890
P. 51
An albuterol metered dose inhaler (MDI) provides 90 mcg of medication in each inhalation. If the total weight of the medication in the canister is 18 mg, how many inhalations will be required to deplete the MDI? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
200
P. 16
Express 0.02% as a ratio strength. (Answer must be numeric; no units or commas; do not enter the 1 and the colon; enter only the number after the colon, as shown here with Xs: 1:XXX.)
5000
P. 20
How many grams of triamcinolone should be used in preparing the following prescription?
Rx: Triamcinolone (w/v) 5% Glycerin qs ad 10 mL Sig. One drop in each ear
(Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
0.5
P. 17
How many milliliters of capsaicin liquid (50 mg/mL) will be needed to prepare 42.5 grams of a 0.15% cream (w/w)? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round the final answer to the nearest TENTH.)
1.3
P. 19
How many milliliters of aminophylline injection containing 250 mg aminophylline in each 10 mL should be used in filling a medication order calling for 10 mg of aminophylline? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
0.4
P. 9
The clinical pharmacist in the Pediatric ICU is asked to determine what rate to run a child's IV at. The IV contains 9 mL of 39.2 % potassium acetate in normal saline to prepare a 1 L bag. The prescriber wants the child to receive 2.5 mEq/hr. (MW of K = 39; MW of acetate = 59). What rate (in mL/hr) would provide the desired mEq/hr of potassium acetate? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
69
P. 36
The prepared IV contains 3528 mg of potassium acetate. Use the MW provided to convert to mEq (potassium acetate, like sodium acetate, has a valence of 1) and then calculate the drip rate.
How many kcals are provided by 91 grams of protein? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
364
P. 51
The pharmacist receives a prescription for "Percocet 5/325 mg tab #24, Sig; i-ii tabs po q 4-6 hrs prn pain x 2 days. NTE 10/d." Choose the correct wording for the prescription label.
Answer
A
Take 1-2 tablets by mouth every 4-6 hours as desired for pain. Do not exceed 10 tablets per day.
B
Take 1-2 tablets by mouth every 4-6 hours as-needed for pain for 2 days. Do not exceed 10 tablets per day.
C
Take up to 2 tablets by mouth every 4 hours as-needed for pain. Do not exceed 10 tablets per day.
D
Take 1-2 tablets by mouth every 4-6 hours as-needed for pain. Do not exceed 6 tablets per day.
E
Take 1-2 tablets by mouth up to 6 times daily as-needed for pain for 2 days. Do not exceed 12 tablets per day.
B
P. 11
Which of the following is the principal extracellular cation?
Answer
A
Sodium
B
Magnesium
C
Calcium
D
Potassium
E
Manganese
A
Sodium is the principal extracellular cation.
What is the specific gravity (SG) of 75 mL of clove oil weighing 78 grams? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
1.04
P. 23
A 30 mL nasal spray delivers 18 sprays per mL of solution. Each spray contains 1.25 mg of active drug. How many milligrams of drug are contained in the 30 mL package? (Answer must be numeric; no units or commas.)
675
P. 16
Express 0.00088% w/v as parts per million (PPM):
8.8%
P. 22
One pint of rifampin oral suspension contains 4,730 milligrams of rifampin. How many grams of rifampin are contained in 120 milliliters of the suspension? (Answer must be numeric; no units or commas; round the final answer to the nearest TENTH.)
1.2
P. 9
A female comes to the pharmacy. She is 5'2" tall and 156 pounds. Select the correct BMI for this patient and the corresponding classification:
Answer
A
23, obese
B
29, overweight
C
23, normal
D
23, overweight
E
29, obese
B
P. 38
A patient will receive 114 grams of protein in the PN bag. How many calories are provided by the protein component? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
456
P. 51
The pharmacy receives the following PN order. How many milliliters of sodium chloride 23.4% (4 mEq/mL) should be added to the PN. (Answer must be numeric; no units or commas.)
Item/Quantities:
Dextrose 270 g
Amino acids 60 g
Sodium chloride 38 mEq
Sodium acetate 16 mEq
Potassium 40 mEq
Magnesium sulfate 10 mEq
Phosphate 21 mmol
Calcium 4.45 mEq
MVI-12 5 mL
Trace elements 1 mL
Vitamin K-1 0.5 mg
Famotidine 10 mg
Regular insulin 40 units
Sterile water qs ad 980 mL
9.5
P. 61
The Cockcroft-Gault equation may not provide a reliable estimate of actual renal clearance in all situations. Some circumstances when an alternate method or formula may be preferable include: (Select ALL that apply.)
Answer
A
When renal function is fluctuating rapidly
B
In end stage renal disease
C
In very young children
D
In young, healthy adults
E
In patients with mild-moderate renal insufficiency
A, B, C
The Cockcroft-Gault equation may not provide a close estimate of actual renal clearance in young children, patients with end-stage renal disease, or patients who are experiencing rapid fluctuations in renal function.
Which of the following statements accurately describes the pH scale?
Answer
A
A lower pH correlates with a higher concentration of hydrogen ions in solution.
B
A higher pH correlates with a higher concentration of hydrogen ions in solution.
C
Solutions with a pH less than 7 are said to be basic.
D
Solutions with a pH greater than 8 are said to be acidic.
E
It measures the tonicity of a solution.
A
A lower pH means more hydronium ions (H3O+, or H+) in solution and is therefore more acidic. The H+, or proton, is the acid. A higher pH is more basic and has less hydronium ions and more hydroxide (OH-) ions in solution. A pH of 7 is said to be neutral.
A patient needs 110 grams of protein/day. If the pharmacy stocks Aminosyn 10%, how many milliliters of fluid will be supplied by the protein component? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
1100
P. 51
Peter is a 46 year old male (274 pounds, 6'3") who has been admitted for bowel resection surgery. Post surgery, he is to be started on PN therapy. The physician wants the patient to receive 1.2 g/kg/day of protein. Calculate his daily protein requirement in grams using his actual body weight. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
149
P. 49
A pharmacist mixes 200 mL of 20% dextrose with 100 mL of 5% dextrose. What is the final dextrose concentration (%w/v)? (Answer must be numeric; no units or commas.)
15
P. 53
Calculate how many grams of dextrose (total) is present, then solve by ratio.
An order is written to add 600 mL of 10% amino acid solution to a PN. The only concentration in stock is a 15% solution. How many milliliters of the 15% solution should the pharmacist add? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
400
P. 52
JF is a 62 year old male admitted with diabetes and peripheral neuropathy.
Medications:
Janumet XR 100/1000 daily
Lyrica 50 mg TID
Lisinopril 10 mg daily
Norco 5/325 HS PRN
D5NS + 20 mEq KCl
The hospital has 1 liter premixed bags of D5NS + 20 mEq KCl and JF's fluid has been running at 80 mL/hr for 8 hours. How many mmols of KCl has the patient received? (MW K = 39; MW Cl = 35.5). (Answer must be numeric; no units or commas.)
12.8
P. 34, 36
First determine how many mEq of KCl the patient has received in the past 8 hours: 20 mEq/1000 mL = X mEq / 640 mL. Next use this number to calculate mg and then mmoles. Remember, when dealing with a monovalent species, the numerical value for mEq and mmols are the same.
All of the epinephrine auto-injectors and prefilled syringes in the hospital have expired or been recalled. The pharmacist must use epinephrine 1:1000 for a patient having an anaphylactic reaction on the floor. The prescriber has ordered "epinephrine 0.5 mg SC stat". How many milliliters of the available epinephrine product should be administered? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
0.5
P. 20
Convert the ratio strength to a percentage strength: epinephrine 1:1000 = 0.1%. Next determine how many milliliters are needed for the dose. Epinephrine 1:1000 is the correct product for SC/IM use.
How many mL of polyethylene glycol 400 (SG = 1.13) are needed to prepare a prescription that includes 54 g of the surfactant/emulsifier (polysorbate)? (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round the final answer to the nearest TENTH.)
47.8
P. 23
Carol Burns is a patient on the medical floor. Earlier today D5 1/2NS + 40 mEq KCl was ordered to run at 75 mL/hr. Unfortunately, an error was made and her 1 liter bag has been running at only 45 mL/hr for the past 4 hours. How many extra mEq of KCl would Ms. Burns need to receive now to equal what she would have gotten if the drip had been hanging at the correct rate for the past 4 hours? (Answer must be numeric; no units or commas.)
4.8
If the bag had been running at 75 mL/hr, the patient would have received 12 mEq KCl in 4 hours. At 45 mL/hr, the patient received only 7.2 mEq. The difference is 4.8 mEq.
A patient in the Emergency Department is receiving D5 1/4 NS + 20 mEq KCl. The 1 liter bag is being run with IV tubing that delivers 15 drops/mL. The patient has been receiving this for 8 hours at a rate of 12 drops/min. How many mEq of potassium has the patient received so far? (Answer must be numeric; no units or commas; round the final answer to the nearest TENTH.)
7.7
First calculate how many drops the patient has received in the past 8 hours (12 drops/min x 60 min/hr x 8 hrs = 5760 drops). Then determine how many mL the patient has received. Lastly set up a proportion to solve for mEqs: 20 mEq/1000 mL = x mEq / 384 mL.
A pharmacist mixed 800 mg of a liquid drug (SG = 0.8) in enough liquid to prepare 2 liters of a final product. What is the ratio strength of the final product? (Answer must be numeric; no units or commas; do not enter the 1 and the colon; enter only the number after the colon, as shown here with Xs: 1:XXX.)
2000
First calculate the number of milliliters of the liquid using the given SG: 0.8 = 0.8 g / X mL. Next determine the percentage strength: 1 mL / 2000 mL = X mL / 100 mL. The percentage strength is 0.05%. Lastly, convert this to a ratio strength.
Express 660 parts per million (PPM) as a percentage. (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1.)
0.066
P. 22
You have tablets that contain 125 mcg of digoxin per tablet. You are crushing the tablets and mixing with an elixir for a 29-month old child weighting 44 lbs. How many digoxin tablets will be needed to compound the following prescription?
Rx: Digoxin Liq. 0.1 mg/mL Disp. 20 mL Sig: 10 mcg per kg PO daily
(Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE tablet.)
16
P. 14
Express 0.5% as a ratio strength. (Answer must be numeric; no units or commas; do not enter the 1 and the colon; enter only the number after the colon, as shown here with Xs: 1:XXX.)
200
P. 20
A pharmacist has a prescription for 30 mL of an eye drop that is to contain benzalkonium chloride 1:750 as a preservative. On the shelf the pharmacist finds 17% benzalkonium chloride. Using a dropper that delivers 25 drops/mL, how many drops will be required to prepare this compounded formula? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
6
First convert the ratio strength to a percentage then determine how many grams of benzalkonium chloride are needed to make 30 mL of the eye drop. Next determine how many mL of the 17% stock solution are needed. From there calculate the number of drops required based on the dropper size.
Renee Flannary is admitted to the hospital for worsening ascites and coughing up blood.
Admission Orders:
Protonix 80 mg IV bolus x 1
Protonix 80 mg/100 mL NS-
infuse at 8 mg/hr
Octreotide 50 mcg IV bolus x 1-
over 3 minutes
Octreotide 500 mcg/250 mL NS-
infuse at 25 mcg/hr
Furosemide 20 mg IV x 1
Labs:
Na (mEq/L) = 129 (135-145)
K (mEq/L) = 3.7 (3.5-5)
Cl (mEq/L) = 103 (95-103)
HCO3 (mEq/L) = 25 (24-30)
BUN (mg/dL) = 24 (7-20)
SCr (mg/dL) = 1.5 (0.6-1.3)
Glucose (mg/dL) = 122 (100-125)
Ca (mg/dL) = 9.1 (8.5-10.5)
Mg (mEq/L) = 2.1 (1.3-2.1)
PO4 (mg/dL) = 3.2 (2.3-4.7)
WBC (cells/mm3) =
13.6 (4-11x10^3)
Hgb (g/dL) = 8.8 (12-16 female)
Hct (%) = 24.2 (36-46 female)
Plt (cells/mm3) =
143 (150-450x10^3)
Procalcitonin (ng/mL) = 27 (â‰¤ 0.15)
AST (IU/L) = 38 (10-40)
ALT (IU/L) = 29 (10-40)
Albumin (g/dL) = 2.8 (3.5-5)
INR = 2.8
Alk Phos (IU/L) = 225 (33-131)
Ammonia (mcg/dL) = 92 (19-60)
Question:
The octeotide drip is started at 1400. After infusing at the ordered rate for 2 hours, the prescriber asks the nurse to titrate up to 50 mcg/hr. How many total hours will the initial bag last? (Answer must be numeric; no units or commas.)
11 HOURS
25 mcg / hr x 250 mL / 500 mcg = 12.5 mL/hr for 2 hours (25 mL infused). Then 50 mcg / hr x 250 mL / 500 mcg = 25 mL/hr. After the first 2 hours, there would be 225 mL remaining in the bag. Once the rate is increased, the drip can run for another 9 hours. 9 hours + 2 hours = 11 hours total.
A patient is receiving 500 mL of 10% Intralipid on Saturdays along with his normal daily PN therapy of 1,580 mL of D20W, 520 mL FreAmine 15% and 30 mL of electrolytes. What is the daily amount of calories provided by the lipids? (Answer must be numeric; no units or commas; round the final answer to the nearest TENTH.)
78.6
P. 55
A pharmacist mixed 500 g of a liquid drug (SG = 0.662) in enough liquid to prepare 2 liters of a final product. What is the percentage strength (v/v) of the final product? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
38 V/V
First calculate the number of milliliters of the liquid using the given SG: 0.662 = 500 g / X mL. Next determine the percentage strength: 755.28 mL / 2000 mL = X mL / 100 mL. Remember to round only at the final step.
A pharmacist is asked to compound 60 mL of an isotonic eye drop. Drug X (a liquid with an E-value of 0.33) and sodium chloride will be used to prepare a final concentration of 1:500 (w/v). How many milligrams of sodium chloride must be added to make the eye drops isotonic? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
500
P. 32-33
First convert the ratio strength to a percentage (0.2%). Drug X accounts for 0.0396 g of NaCl. It would require 0.54 g of NaCl if that was all we were using. Lastly, 0.54 g - 0.0396 = ~0.5 g NaCl (or 500 mg, rounded as per the instructions).
Hilary Kaplan is a 4 month old child with congenital heart disease.
Demographics/Vitals:
Weight: 5 pounds 8 ounces
Medications:
Palivizumab (Synagis) 15 mg/kg IM Qmonth
Tobramycin 2 mg/kg IV Q8H
Question:
How many milligrams of palivizumab should the patient receive today? (Answer must be numeric; no units or commas; include a leading zero when the answer is less than 1; round the final answer to the nearest TENTH.)
37.5
P. 8
The patient's weight can be converted to kg with one of two conversion factors: 1 lb = 16 ounces or 1 ounce = 28.4 grams.
If one 10 mL vial contains 0.05 g of diltiazem, how many milliliters should be administered to provide a 150 mg dose of diltiazem? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
30
P. 9
How many milligrams of caffeine will be contained in each caplet of the prescription below?
Rx: Acetaminophen 12 g Aspirin 12 g Caffeine 3.12 g M. ft. caps. no. 48 Sig. i-ii caplets prn HA
(Answer must be numeric; no units or commas.)
65
P. 15
Renee Flannary is admitted to the hospital for worsening ascites and coughing up blood.
Admission Orders:
Protonix 80 mg IV bolus x 1
Protonix 80 mg/100 mL NS-
infuse at 8 mg/hr
Octreotide 50 mcg IV bolus x 1-
over 3 minutes
Octreotide 500 mcg/250 mL NS-
infuse at 50 mcg/hr
Furosemide 20 mg IV x 1
Labs:
Na (mEq/L) = 129 (135-145)
K (mEq/L) = 3.7 (3.5-5)
Cl (mEq/L) = 103 (95-103)
HCO3 (mEq/L) = 25 (24-30)
BUN (mg/dL) = 24 (7-20)
SCr (mg/dL) = 1.5 (0.6-1.3)
Glucose (mg/dL) = 122 (100-125)
Ca (mg/dL) = 9.1 (8.5-10.5)
Mg (mEq/L) = 2.1 (1.3-2.1)
PO4 (mg/dL) = 3.2 (2.3-4.7)
WBC (cells/mm3) =
13.6 (4-11x10^3)
Hgb (g/dL) = 8.8 (12-16 female)
Hct (%) = 24.2 (36-46 female)
Plt (cells/mm3) =
143 (150-450x10^3)
Procalcitonin (ng/mL) = 27 (â‰¤ 0.15)
AST (IU/L) = 38 (10-40)
ALT (IU/L) = 29 (10-40)
Albumin (g/dL) = 2.8 (3.5-5)
INR = 2.8
Alk Phos (IU/L) = 225 (33-131)
Ammonia (mcg/dL) = 92 (19-60)
Question:
Convert Ms. Flannary's procalcitonin level to mcg/mL so the medical team can use a published treatment algorithm. (Answer must be numeric; no units or commas; include a leading zero when the answer is less than 1.)
0.027
1 mg = 1,000,000 ng
A patient is receiving 650 mL of 10% lipids. How many kcals is the patient receiving from the lipids? (Answer must be numeric; no units or commas.)
715
P. 54
Express 1:5000 as a percentage strength. (Answer must be numeric; no units or commas; include a leading zero if answer is less than 1.)
0.02
P. 20
Renee Flannary is admitted to the hospital for worsening ascites and coughing up blood.
Admission Orders:
Protonix 80 mg IV bolus x 1
Protonix 80 mg/100 mL NS-
infuse at 8 mg/hr
Octreotide 50 mcg IV bolus x 1-
over 3 minutes
Octreotide 500 mcg/250 mL NS-
infuse at 25 mcg/hr
Furosemide 20 mg IV x 1
Labs:
Na (mEq/L) = 129 (135-145)
K (mEq/L) = 3.7 (3.5-5)
Cl (mEq/L) = 103 (95-103)
HCO3 (mEq/L) = 25 (24-30)
BUN (mg/dL) = 24 (7-20)
SCr (mg/dL) = 1.5 (0.6-1.3)
Glucose (mg/dL) = 122 (100-125)
Ca (mg/dL) = 9.1 (8.5-10.5)
Mg (mEq/L) = 2.1 (1.3-2.1)
PO4 (mg/dL) = 3.2 (2.3-4.7)
WBC (cells/mm3) =
13.6 (4-11x10^3)
Hgb (g/dL) = 8.8 (12-16 female)
Hct (%) = 24.2 (36-46 female)
Plt (cells/mm3) =
143 (150-450x10^3)
Procalcitonin (ng/mL) = 27 (â‰¤ 0.15)
AST (IU/L) = 38 (10-40)
ALT (IU/L) = 29 (10-40)
Albumin (g/dL) = 2.8 (3.5-5)
INR = 2.8
Alk Phos (IU/L) = 225 (33-131)
Ammonia (mcg/dL) = 92 (19-60)
Question:
Calculate the duration of infusion (in hours) for the Protonix drip. (Answer must be numeric; no units or commas; include a leading zero when the answer is less than 1.)
10
80 mg x 1 hr / 8 mg = 10 hrs
What molar ratio (salt:acid) would be required to make a buffer solution of sodium acetate and acetic acid with pH of 5.76. The pKa of acetic acid is 4.76. (Answer must be numeric; no units or commas; do not enter the 1 and the colon; enter only the number before the colon, as shown here with Xs: XXX:1.)
10
P. 74
After a few steps, you will be left with the following: 1 = log [x], then x = 10. The molar ratio is 10:1.
JF is a 62 year old male admitted with diabetes and peripheral neuropathy.
Medications:
Janumet XR 100/1000 daily
Lyrica 50 mg TID
Lisinopril 10 mg daily
Norco 5/325 HS PRN
D5NS + 20 mEq KCl
The Emergency Department has 1 liter pre-mixed bags of D5NS + 20 mEq KCl. The first bag was hung earlier today and the rate was not entered in the computer system. The pharmacist wants to clarify the rate and notes on the infusion pump that the patient has received 640 mL in the past 8 hours. Assuming the rate has been consistent since the bag was hung, at what rate (mL/hr) is the fluid currently running? (Answer must be numeric; no units or commas.)
80
640 mL / 8 hours = 80 mL/hr
Renee Flannary is admitted to the hospital for worsening ascites and coughing up blood.
Admission Orders:
Protonix 80 mg IV bolus x 1
Protonix 80 mg/100 mL NS-
infuse at 8 mg/hr
Octreotide 50 mcg/1 mL IV bolus
x 1 - over 3 minutes
Octreotide 500 mcg/250 mL NS-
infuse at 50 mcg/hr
NS 1 liter x 1 - over 2 hrs
Furosemide 20 mg IV x 1
Labs:
Na (mEq/L) = 129 (135-145)
K (mEq/L) = 3.7 (3.5-5)
Cl (mEq/L) = 103 (95-103)
HCO3 (mEq/L) = 25 (24-30)
BUN (mg/dL) = 24 (7-20)
SCr (mg/dL) = 1.5 (0.6-1.3)
Glucose (mg/dL) = 122 (100-125)
Ca (mg/dL) = 9.1 (8.5-10.5)
Mg (mEq/L) = 2.1 (1.3-2.1)
PO4 (mg/dL) = 3.2 (2.3-4.7)
WBC (cells/mm3) =
13.6 (4-11x10^3)
Hgb (g/dL) = 8.8 (12-16 female)
Hct (%) = 24.2 (36-46 female)
Plt (cells/mm3) =
143 (150-450x10^3)
Procalcitonin (ng/mL) = 27 (â‰¤ 0.15)
AST (IU/L) = 38 (10-40)
ALT (IU/L) = 29 (10-40)
Albumin (g/dL) = 2.8 (3.5-5)
INR = 2.8
Alk Phos (IU/L) = 225 (33-131)
Ammonia (mcg/dL) = 92 (19-60)
Question:
Convert Ms. Flannary's ammonia level to mcg/mL so the medical team can use a published treatment algorithm. (Answer must be numeric; no units or commas; include a leading zero when the answer is less than 1.)
0.92
100 mL = 1 dL (or 1 mL = 0.01 dL)
Vance Buckly has an order for the following PN:
Item/Quantities:
Dextrose 250 g
Amino acids 50 g
Sodium acetate 16 mEq
Sodium chloride 38 mEq
Potassium 40 mEq
Magnesium sulfate 10 mEq
Phosphate 21 mmol
Calcium 4.45 mEq
MVI-12 5 mL
Trace elements 1 mL
Vitamin K-1 0.5 mg
Famotidine 10 mg
Regular insulin 40 units
Sterile water qs ad 980 mL
Question:
How many milliliters of 23.4% sodium chloride should be added to this PN? (MW of Na = 23; MW of Cl = 35.5). (Answer must be numeric; no units or commas.)
9.5
P. 36
The pharmacy stocks FreAmine 8.5%. How many milliliters will be needed to provide 132 g of protein? (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
1553
P. 51
Hilary Kaplan is a 4 month old child with congenital heart disease.
Demographics/Vitals:
Weight: 5 pounds 8 ounces
Medications:
Palivizumab (Synagis) 15 mg/kg IM Qmonth
Tobramycin 2 mg/kg IV Q8H
Question:
How many milligrams of tobramycin will the patient receive daily? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
15
P. 8
The patient's weight can be converted to kg with one of two conversion factors: 1 lb = 16 ounces or 1 ounce = 28.4 grams.
A pharmacist has a prescription for 90 compounded glycerin suppositories using the following formula:
Glycerin 91 g
Sodium stearate 9 g
Purified water 5 g
M. ft. suppositories #50
How many mL of glycerin will be needed to prepare the desired number of suppositories? (SG of glycerin = 1.25). (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
131
Use the SG provided to determine how many mL glycerin are needed to make 50 suppositories: 1.25 = 91 g/ X mL. Then determine how many mL will be needed for 90 suppositories using a ratio: 72.8 mL glycerin / 50 supp = X mL glycerin / 90 supp.
A new patient is being seen today in the pharmacist-run disease state management clinic. She is from France and just moved to the US. She is very knowledgable about her medical conditions. She states that her most recent total cholesterol level was 5.2 mmol/L. The pharmacist knows that his lab reports total cholesterol in mg/dL. He looks online and determines that the MW of cholesterol is 387. What is the patient's total cholesterol in mg/dL? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
201
P.80
PK/BIOSTAT/PE CALCULATIONS
PK/BIOSTAT/PE CALCULATIONS
A newly approved drug has a volume of distribution of 82 L and a clearance of 9.26 L/hr. Calculate the half-life (in hours) of this drug. (Answer must be numeric; no units or commas; include a leading zero when answer is less than 1; round final answer to the nearest TENTH.)
6.1
Pg 134
A dose of 750 mg of acetaminophen is administered to a patient. A blood sample is drawn two hours after the dose is administered. The concentration of acetaminophen is measured as 8 mcg/mL. Acetaminophen has a volume of distribution of 51 L. How many milligrams of drug remain in the body 2 hours after the dose is administered? (Answer must be numeric; no units or commas.)
408
Pg 130
Following a 400 mg dose of cefpodoxime, the terminal elimination rate constant was determined to be 0.38 hr-1. Calculate the half-life (in hours) of cefpodoxime. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
2
Pg. 134
An intravenous drug is administered as a 225 mg dose. The resulting AUC is 52 mg x hr/mL. Bioavailability of the oral formulation is 50%. Calculate the clearance of this drug in mL/hr. (Answer must be numeric; no units or commas; round final answer to the nearest HUNDREDTH.)
4.33
Bioavailability is 100% (F = 1) following intravenous administration. Bioavailability of the oral formulation is not needed for this calculation. Cl = 225 / 52 = 4.33 mL/hr.
A 2 mcg/kg dose of fentanyl is ordered for a patient in the ICU. The patient weighs 110 pounds. Following the intravenous dose of fentanyl, plasma levels of fentanyl were measured. The extrapolated concentration at time zero was determined to be 0.286 mcg/L. Calculate the volume of distribution (in liters) for fentanyl. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
350
Pg.130
AUC values of drug X following IV administration of 50 mg and oral administration of 100 mg were found to be 70 mg x hr/mL and 90 mg x hr/mL respectively. Calculate the absolute bioavailability of drug X. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
64
Pg 129
Doxycycline has a clearance of 4.5 L/hr and a volume of distribution of 65 L. Calculate the half-life (in hours) of doxycycline. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
10
Pg 134
Data was obtained after oral and intravenous administration of drug X in volunteers of average weight 50 kg. Following an intravenous dose of 1.2 mg/kg, administered as a bolus injection, the AUC was 4.50 mg x hr/mL. Following a 4.0 mg/kg oral dose, administered as a solution, the AUC was 8.2 mg x hr/mL. Calculate the absolute bioavailability of drug X. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
55
pg. 129
Following a 400 mg dose of voriconazole IV the area under the curve is measured at 38 mcg x hr/mL. Calculate the apparent clearance of voriconazole in L/hr. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
11
Pg.132
A patient is receiving vancomycin 1,250 mg IV Q12H. The following drug levels are available and orders to hold vancomycin are received after the first level comes back.
1/8: 41.45 mcg/mL at 1800
1/8: 35.6 mcg/mL at 2230
1/9: 22.55 mcg/mL at 1200
1/9: 17.8 mcg/mL at 1900
1/9: 16.36 mcg/mL at 2130
What is the patient's vancomycin half-life in hours? (Answer must be numeric; no units or commas; round the final answer to the nearest TENTH.)
20.5
Half-life is the time required for the drug concentration to decrease by 50%.
A new antibiotic for community-acquired pneumonia (CAP) was recently FDA approved. The drug was presented at the hospital's Pharmacy and Therapeutics Committee meeting. The drug monograph included the following information:
Community-acquired pneumonia dosing (IV): 675 mg IV Q8H
Community-acquired pneumonia dosing (PO): 675 mg PO TID
Protein binding: 18%
Metabolism: partially hepatic
Half-life (elimination): 1.6 - 2.1 hours
What is the bioavailability of this new drug?
100%
Pg. 128
A study was conducted to assess the pharmacokinetics of drug X in volunteers of average weight 110 pounds. Following an intravenous dose of 1.2 mg/kg, administered as a bolus injection, the AUC was determined to be 4.5 mg x hr/mL and the volume of distribution was 62 L. Following a 4 mg/kg oral dose, administered as a capsule, the AUC was 7.36 mg x hr/mL and the volume of distribution was 59 L. Calculate the absolute bioavailability of drug X. (Answer must be numeric; no units or commas; round final answer to the nearest WHOLE number.)
49
Pg. 129
An oral drug is administered as a 225 mg dose. The resulting AUC is 52 mg x hr/mL. Bioavailability of the oral formulation is 50%. Calculate the clearance of this drug in mL/hr. (Answer must be numeric; no units or commas; round final answer to two decimal places.)
2.16
Bioavailability can be presented as a percentage or a decimal. Cl = 225/52 x 0.5 = 2.1634, rounded to 2.16 mL/hr.
A report of a clinical trial of a new antipyretic (Feverstop) versus placebo, concluded that the new drug gave a higher proportion of success than did the placebo. The study indicated an alpha of 0.05. The report ended with the statement that the trial was statistically significant (p-value < 0.05). In light of this information, we may conclude:
The probability of the reported finding or one more extreme by chance is less than 1 in 20.
The p-value refers to the null hypothesis which is Group 1 = Group 2 (meaning there is no difference between the drug and the placebo). The p-value is the probability of obtaining a test statistic as extreme as the one actually observed as a result of chance alone.
Choose the best description of the purpose of a pharmacoeconomic analysis:
To identify and measure the costs and the consequences of drugs.
Pharmacoeconomics takes into account broader costs beyond just drug acquisition costs and is an important tool to ensure resources are used wisely.
BACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin.
METHODS: In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause.
RESULTS: The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.28% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P < 0.001 for noninferiority; P = 0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P < 0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P = 0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P < 0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P = 0.42).
CONCLUSIONS: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.
From the abstract above, what is the number needed to treat with apixiban compared to warfarin to prevent one incidence of the primary outcome?
313
The number needed to treat is 1/ARR. ARR = 1.6 - 1.28 = 0.32%; therefore, 1/0.0032 = 312.5, or 313.
A new drug for stroke prevention, CLOTBUST, was studied. The trial enrolled 2,546 patients. In the CLOTBUST arm, 39 out of 1,281 patients had a stroke compared with 64 patients out of 1,265 patients in the aspirin arm, p-value = 0.025. What is the number needed to treat to prevent one stroke in this trial?
50
Number needed to treat (NNT) is 1/ARR. Therefore, 1/0.02 = 50 patients. Fifty patients will need to be treated to prevent one stroke.
The JUPITER trial studied the benefits of rosuvastatin 20 mg PO daily versus placebo. The primary outcome of the trial was the occurrence of a first major cardiovascular event, defined as nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, an arterial revascularization procedure, or confirmed death from cardiovascular causes. At the time of study termination, 142 first major cardiovascular events had occurred in the rosuvastatin group, as compared with 251 in the placebo group, p-value = 0.00001. Each arm had 8,901 patients. What was the relative risk reduction if randomized to rosuvastatin in this trial?
43
Relative risk reduction = 1-RR. Event rates per arm: 142/8,901 = 1.6% in rosuvastatin arm and 251/8,901 = 2.8% in placebo arm. 1.6/2.8 = 0.57. Therefore, 1-0.57 = 0.43, or 43%.
Abstract
BACKGROUND:
Angiotensin-converting-enzyme inhibitors improve the outcome among patients with left ventricular dysfunction, whether or not they have heart failure. We assessed the role of an angiotensin converting-enzyme inhibitor, ramipril, in patients who were at high risk for cardiovascular events but who did not have left ventricular dysfunction or heart failure.
METHODS:
A total of 9,297 high-risk patients who had evidence of vascular disease or diabetes plus one other cardiovascular risk factor and who were not known to have a low ejection fraction or heart failure were randomly assigned to receive ramipril or matching placebo for a mean of five years. The primary outcome was a composite of myocardial infarction, stroke, or death from cardiovascular causes.
RESULTS:
A total of 4,645 patients were assigned to receive ramipril 10 mg daily and 4,652 were assigned to receive placebo. Of the patients taking ramipril, 650 patients reached the primary endpoint as compared with 826 patients who were assigned to receive placebo (p < 0.001). Treatment with ramipril reduced the rates of death from cardiovascular causes (6.1% vs. 8.1% in the placebo group, p < 0.001), myocardial infarction (9.9% vs. 12.3%, p < 0.001), stroke (3.4% vs. 4.9%, p < 0.001) and death from any cause (10.4% vs. 12.2%, p = 0.005).
CONCLUSION:
Ramipril significantly reduces the rates of death, myocardial infarction, and stroke in a broad range of high-risk patients who are not known to have a low ejection fraction or heart failure.
Question:
From the abstract above, what is the number needed to treat to prevent the composite endpoint of myocardial infarction, stroke, or death from cardiovascular causes? Round up to the nearest WHOLE number.
27
The number needed to treat is defined as 1/ARR, or 26.3 rounded up to 27. Therefore, 27 patients need to be treated for 5 years to prevent 1 composite endpoint.
A clinical trial is conducted on a new drug, LoSod. LoSod is found to reduce serum sodium to 131 mEq/L, with a 95% confidence interval of 128.7 mEq/L to 133.3 mEq/L. What is the correct interpretation of this 95% confidence interval?
There is a 95% chance that the interval contains the true population value.
A confidence interval gives an estimated range of values which is likely to include an unknown population parameter; the estimated range being calculated from a given set of sample data.
A trial compared Drug A to placebo and found that Drug A lowered LDL by an additional 5%, on average. If the alpha is set to 0.05 and the p-value was reported to be 0.03. Which of the following is/are true regarding this trial? (Select ALL that apply.)
Drug A is stastically significantly better than the placebo
The chance of a Type I error is less than 5%
The investigator should fail to accept the null hypothesis
A measure of statistical significance is not the same as "clinical significance". For example, if a drug lowers LDL by 5%, it may be statistically significant versus the placebo, but clinically it probably would not be used much since other drugs lower LDL to a much greater degree.
Correlation in a clinical trial describes:
Answer
A
A way to assess statistical significance
B
The relationship between two variables
C
The variance from the mean
D
The data being grouped together
E
A cause and effect relationship
B
If the data are correlated and the data points are plotted, a straight line can be drawn that will run through, or close to, most of the data points. Data can be positively or negatively correlated depending on the direction of the slope of the line. If the data points are not correlated, the data points will be scattered all over the plot.
What is the term used for the inactive or inert substance administered to a patient that serves as a reference to determine the effects of a real drug or other intervention?
Answer
A
The excipient
B
The standard deviation
C
The null hypothesis
D
The placebo
E
The desiccant
D
Placebos are used in clinical trials to blind people to their treatment allocation and minimize bias. Placebos should be indistinguishable from the active intervention to ensure adequate blinding.
A clinical trial is published about a new drug, NOPAINZ, for pain reduction. There are 200 patients randomized; 100 patients to NOPAINZ and 100 patients to placebo. The study found that pain was alleviated in 90 patients taking NOPAINZ and in 50 patients taking placebo. Calculate the relative risk reduction (RRR) in this trial. (Enter the relative risk reduction as a decimal, not a percentage.)
0.8
Relative risk reduction (RRR) = 1-RR (relative risk). The relative risk is 0.2. Therefore, 1-0.2 = 0.8.
What is the definition of a Type I error?
Answer
A
The degree to which a study accurately reflects or assesses the specific concept that the researcher is attempting to measure but misses the mark.
B
The null hypothesis is true, but is rejected in error.
C
The study was not large enough to detect a meaningful difference between treatment groups.
D
The null hypothesis is false, but is accepted in error.
E
A clinical trial with too many confounding variables.
B
A Type I error means that the null hypothesis is true but is rejected in error. For example, if the p-value is 0.05, it means that less than 5% of the time the null hypothesis will be rejected in error, or a type I error will have occurred.
Strongheart Study for Patients with NYHA Functional Class II-IV
BACKGROUND: Strongheart is a new drug being investigated for chronic heart failure patients.
METHODS: We enrolled 3,991 patients with chronic heart failure in New York Heart Association (NYHA) functional class II-IV and with an ejection fraction of 0.40 or less, stabilized on optimal standard therapy, in a double-blind, randomized controlled study. Randomization was preceded by a 2-week single-blind placebo run-in period. Of the 3,991 patients, 1,990 patients were randomly assigned to Strongheart 12.5 mg daily and 2,001 patients were assigned to placebo. The target dose was 200 mg once daily and doses were up-titrated over 8 weeks. Our primary endpoint was all-cause mortality, analyzed by intention to treat.
RESULTS: The study was stopped early on the recommendation of the independent safety committee. Mean follow-up time was 1 year. All-cause mortality was lower in the Strongheart group than in the placebo group (146 patient-deaths versus 219 patient-deaths; p = 0.00009, [95% CI 0.53-0.81]). There were fewer sudden deaths in the Strongheart group than in the placebo group (79 vs. 132; p = 0.0002) and deaths from worsening heart failure (30 vs 58; p = 0.0023).
CONCLUSIONS: Strongheart once daily in addition to optimal standard therapy improved survival.
From the abstract above, what is the number needed to treat with Strongheart to prevent 1 death? Round up to the nearest WHOLE number.
28
The number needed to treat is defined as 1/ARR, or 27.7 rounded up to 28. Therefore, 28 patients need to be treated for 1 year to prevent 1 death. Be careful not to confuse the secondary outcomes (sudden death and deaths from worsening heart failure) with the primary outcome of the study, which was all-cause mortality.
Question
A pharmacist is presenting the Helsinki trial which investigated gemfibrozil 1,200 mg daily versus control. The results showed that CHD events were 2.7% in the gemfibrozil arm versus 4.1% in the control group, with a p-value of < 0.02. What is the relative risk reduction of CHD events in this trial?
Answer
A
44%
B
34%
C
24%
D
22%
E
18%
B
Relative risk reduction = 1-RR. Since RR = 0.66, then relative risk reduction is 1 - 0.66 = 0.34.
A pharmacist is conducting an analysis to determine the benefits of a diabetes treatment regimen in terms of both cost and clinical outcomes measured as a reduction in A1C values. Choose the type of analysis the pharmacist will perform:
Answer
A
A cost utility analysis
B
A cost minimization analysis
C
A cost effectiveness analysis
D
A cost control analysis
E
A meta analysis
C
The most common tool used in pharmacoeconomic research is the cost-effectiveness analysis, which compares the clinical effects of therapy (such as mortality, morbidity) to their net costs.
A researcher gathered all vitamin E studies from the past ten years. Vitamin E was used for a variety of conditions. The populations studied as well as the vitamin E formulations and doses were all different. However, the researcher did the best he could and compared the incidences of cardiovascular-related mortality in those taking vitamin E supplements versus those that did not. Describe this type of study:
Answer
A
Observational study
B
Case control study
C
Cohort study
D
Controlled clinical trial
E
Meta analysis
E
A meta analysis is a systematic review of many different but related studies in order to integrate the results. These are often done and can be useful to pool smaller trials into a larger group for analysis (e.g., Cochrane reviews).
A clinical trial reports that patients taking a new drug, NO-GO, experience less incontinence episodes. The number of incontinent episodes (the primary endpoint) was 16.4% in the NO-GO group and 28.7% in the placebo group. The trial randomized 600 patients (300 patients in each arm). What is the number needed to treat to prevent 1 incontinence episode?
9
The number needed to treat is 1/ARR. ARR = 28.7% - 16.4% = 12.3%. Therefore, NNT = 1/0.123 = 8.13, rounded up to 9 since we cannot treat a fraction of a person.
A clinical trial reports that patients taking a new drug, NO-GO, experience less incontinence episodes. The number of incontinent episodes (the primary endpoint) was 16.4% in the NO-GO group and 28.7% in the placebo group. The trial randomized 600 patients (300 patients in each arm). What is the absolute risk reduction? (Do not include the percentage sign when you type in the number.)
12.3
The absolute risk reduction is calculated by subtracting the event rates of the two groups. Therefore, 28.7% - 16.4% = 12.3%
In biostatistics, what is meant by the mean of a group of values?
Answer
A
The calculated value by adding up all the numbers and subtracting by 100
B
The product of all the values divided by the number of values
C
The value that occurs most frequently in the series
D
The average
E
The value in the middle of the list
D
The mean is found by adding up the values in a list, and dividing by the number of values.
Strongheart Study for Patients with NYHA Functional Class II-IV
BACKGROUND: Strongheart is a new drug being investigated for chronic heart failure patients.
METHODS: We enrolled 3,991 patients with chronic heart failure in New York Heart Association (NYHA) functional class II-IV and with an ejection fraction of 0.40 or less, stabilized on optimal standard therapy, in a double-blind, randomized controlled study. Randomization was preceded by a 2-week single-blind placebo run-in period. Of the 3,991 patients, 1,990 patients were randomly assigned to Strongheart 12.5 mg daily and 2,001 patients were assigned to placebo. The target dose was 200 mg once daily and doses were up-titrated over 8 weeks. Our primary endpoint was all-cause mortality, analyzed by intention to treat.
RESULTS: The study was stopped early on the recommendation of the independent safety committee. Mean follow-up time was 1 year. All-cause mortality was lower in the Strongheart group than in the placebo group (146 patient-deaths versus 219 patient-deaths; p = 0.00009, [95% CI 0.53-0.81]). There were fewer sudden deaths in the Strongheart group than in the placebo group (79 vs. 132; p = 0.0002) and deaths from worsening heart failure (30 vs 58; p = 0.0023).
CONCLUSIONS: Strongheart once daily in addition to optimal standard therapy improved survival.
From the abstract above, what is the absolute risk reduction of the primary endpoint of all-cause mortality in patients randomized to the Strongheart group? (Round to the nearest TENTH. Put your answer in percentage form. Do not include the percentage sign when you type in the number.)
3.6
The absolute risk reduction is the absolute difference in outcome rates between two groups. 146/1,990 = 0.073, or 7.3%. 219/2,001 = 0.109, or 10.9%. 10.9% - 7.3% = 3.6%.
Choose the categories that represent direct medical costs: (Select ALL that apply.)
Answer
A
Cost of a prescription
B
Quality of life
C
Cost of a surgery
D
Length of a hospital stay
E
Pain and suffering
A,C,D
The cost of drugs, the cost of surgery, hospital length of stay are all examples of direct costs.
A clinical trial is published about a new drug, NOPAINZ, for pain reduction. There are 200 patients randomized; 100 patients to NOPAINZ and 100 patients to placebo. The study found that pain was alleviated in 90 patients taking NOPAINZ and in 50 patients taking placebo. Calculate the absolute risk reduction (ARR) in this trial. (Enter the absolute risk reduction as a decimal and not a percentage.)
0.4
Absolute risk reduction (ARR) = 0.5 - 0.1 = 0.4
Abstract
BACKGROUND:
Angiotensin-converting-enzyme inhibitors improve the outcome among patients with left ventricular dysfunction, whether or not they have heart failure. We assessed the role of an angiotensin converting-enzyme inhibitor, ramipril, in patients who were at high risk for cardiovascular events but who did not have left ventricular dysfunction or heart failure.
METHODS:
A total of 9,297 high-risk patients who had evidence of vascular disease or diabetes plus one other cardiovascular risk factor and who were not known to have a low ejection fraction or heart failure were randomly assigned to receive ramipril or matching placebo for a mean of five years. The primary outcome was a composite of myocardial infarction, stroke, or death from cardiovascular causes.
RESULTS:
A total of 4,645 patients were assigned to receive ramipril 10 mg daily and 4,652 were assigned to receive placebo. Of the patients taking ramipril, 650 patients reached the primary endpoint as compared with 826 patients who were assigned to receive placebo (p value < 0.001). Treatment with ramipril reduced the rates of death from cardiovascular causes (6.1% vs. 8.1% in the placebo group, p < 0.001), myocardial infarction (9.9% vs. 12.3%, < 0.001), stroke (3.4% vs. 4.9%, p < 0.001) and death from any cause (10.4% vs. 12.2%, p = 0.005).
CONCLUSION:
Ramipril significantly reduces the rates of death, myocardial infarction, and stroke in a road range of high-risk patients who are not known to have a low ejection fraction or heart failure.
Question:
From the abstract above, what is the relative risk reduction of the primary endpoint of myocardial infarction, stroke, or death from cardiovascular causes?
D
Relative risk reduction is defined as 1 minus relative risk. The relative risk is calculated as 0.79, so the relative risk reduction is 0.21 (1-0.79).
A new drug for stroke prevention, CLOTBUST, was studied. The trial enrolled 2,546 patients. In the CLOTBUST arm, 39 out of 1,281 patients had a stroke compared with 64 patients out of 1,265 patients in the aspirin arm, p-value = 0.025. What was the relative risk reduction of stroke in this trial?
Answer
A
1
B
0.9
C
0.4
D
0.3
E
0.2
C
Relative risk reduction = 1-RR. Since the RR is calculated to be 0.6, the relative risk reduction is 1 - 0.6 = 0.4.
A pharmacy intern has been asked by his preceptor to gather 200 discharged patient charts from the chart room. He has been told that half the charts should be patients who received proton pump inhibitor (PPI) therapy while hospitalized. The other half should be patients with similar conditions and length of stay but who did not receive PPI therapy. The pharmacist wishes to conduct a study to see if there is any difference in the incidence of nosocomial infection in the PPI group versus the non-PPI group. Which of the following describes this type of study? (Select ALL that apply.)
Answer
A
Cohort study
B
Meta analysis
C
Case control study
D
Controlled clinical study
E
Observational study
A, E
A cohort study is a type of observational study. This study describes a retrospective cohort (the cohort is discharged patients). These patients are then evaluated to determine if they were receiving PPIs, and then the outcome of nosocomial pneumonia is assessed. To be a case control study, one would need to start out by identifying the outcome (the patients who developed pneumonia) which was not done at the onset of the study.
A pharmaceutical company wished to show that their antiplatelet agent worked better than placebo. They enrolled 12,000 patients at many different research sites. They worked with the physicians to ensure that the patients were randomly assigned to the antiplatelet agent or to a placebo. Both the patients and researchers did not know which patients received the active drug. Choose the correct statement:
Answer
A
The trial was open-label
B
The trial was single-blinded
C
The trial was double-blinded
D
The trial was observational in nature
E
The trial was not blinded and was multi-center
C
Double-blinding, the best type of controlled clinical study, means that neither the subjects nor the researchers know which subjects received the active drug and which received the placebo.
Strongheart Study for Patients with NYHA Functional Class II-IV
BACKGROUND: Strongheart is a new drug being investigated for chronic heart failure patients.
METHODS: We enrolled 3,991 patients with chronic heart failure in New York Heart Association (NYHA) functional class II-IV and with an ejection fraction of 0.40 or less, stabilized on optimal standard therapy, in a double-blind, randomized controlled study. Randomization was preceded by a two-week single-blind placebo run-in period. Of the 3,991 patients, 1,990 patients were randomly assigned to Strongheart 12.5 mg daily and 2,001 patients were assigned to placebo. The target dose was 200 mg once daily and doses were up-titrated over 8 weeks. Our primary endpoint was all-cause mortality, analyzed by intention to treat.
RESULTS: The study was stopped early on the recommendation of the independent safety committee. Mean follow-up time was 1 year. All-cause mortality was lower in Strongheart group than in the placebo group (146 patient-deaths versus 219 patient-deaths; p = 0.00009, [95% CI 0.53-0.81]). There were fewer sudden deaths in the Strongheart group than in the placebo group (79 vs. 132; p = 0.0002) and deaths from worsening heart failure (30 vs 58; p = 0.0023).
CONCLUSIONS: Strongheart once daily in addition to optimal standard therapy improved survival.
From the abstract above, what is the relative risk of the primary endpoint in the Strongheart group versus the placebo group? (Round to the nearest HUNDREDTH. Enter the relative risk as a decimal, not a percentage).
0.67
The relative risk is the probability of the event occurring in the exposed group versus the non-exposed group.
BACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin.
METHODS: In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause.
RESULTS: The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.28% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P < 0.001 for noninferiority; P = 0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P < 0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P = 0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P < 0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P = 0.42).
CONCLUSIONS: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.
From the abstract above, what is the relative risk reduction of the primary outcome in patients receiving apixaban compared to warfarin? Round to the nearest WHOLE number. (Enter your answer as a percentage but do not enter the percentage sign.)
20
Relative risk reduction is defined as 1 minus relative risk. The relative risk is calculated as 0.8, so the relative risk reduction is 0.20 or 20% (1-0.8).
In biostatistics, what is meant by the median of a group of values?
Answer
A
The value in the middle of a list
B
The value in the middle of a ranked list
C
The average
D
The variance squared
E
The value that occurs most frequently
B
The median is found by arranging all the observations in numerical order (lowest to highest or highest to lowest, or ranked) and selecting the value in the middle of the list.
A pharmacist is considering which beta blocker should be preferred at his institution. He has narrowed his search down to two agents. Each drug provides similar health benefits, has similar tolerability and is dosed once daily. The pharmacist will base his decision on the drug that can be purchased at the lower cost. He will use the following analysis to choose the beta blocker for his institution's formulary:
Answer
A
A cost minimization analysis
B
A cost effectiveness analysis
C
A cost control analysis
D
A meta analysis
E
A cost utility analysis
A
Once the benefit of various drugs is considered equivalent (such as choosing which ACEIs or ARBs to have on the formulary), the next step is to find which one is less expensive.
A very large study has measured the body weight of everyone living west of the Mississippi River. If the values of all the weights were plotted, the graph would resemble this shape:
Answer
A
A bell-shaped curve
B
A parabola
C
A quadrilateral
D
A bell-shaped curve skewed to the left
E
A bell-shaped curve skewed to the right
A
If many data points are plotted from a large population group, the distribution would be normal (a normal distribution), or Gaussian, or bell-shaped curve.
A pharmaceutical company wished to show that their antiplatelet agent worked better than placebo. They enrolled 12,000 patients at many different research sites. They worked with the physicians to ensure that the patients were randomly assigned to the antiplatelet agent or to a placebo. Both the patients and physicians did not know which patients received the active drug. Describe this type of trial:
Answer
A
Open-label clinical trial
B
Controlled clinical trial
C
Crossover trial
D
Cross sectional trial
E
Propensity matching study
B
A study group is compared to one or more control (comparison) groups in a controlled setting.
A clinical trial is published about a new drug, NOPAINZ, for pain reduction. There are 200 patients randomized; 100 patients to NOPAINZ and 100 patients to placebo. The study found that pain was alleviated in 90 patients taking NOPAINZ and in 50 patients taking placebo. Calculate the relative risk in this trial. (Enter the relative risk as a decimal, not a percentage.)
0.2
Relative risk is the likelihood of an unfavorable event (in this case, pain) occurring in the exposed group versus in the non-exposed group. Therefore, 10 of the 100 patients had pain in the Nopainz group, and 50 of the 100 patients had pain in the placebo group. Therefore, 0.1/0.5 is 0.2.
Abstract
BACKGROUND:
Angiotensin-converting-enzyme inhibitors improve the outcome among patients with left ventricular dysfunction, whether or not they have heart failure. We assessed the role of an angiotensin converting-enzyme inhibitor, ramipril, in patients who were at high risk for cardiovascular events but who did not have left ventricular dysfunction or heart failure.
METHODS:
A total of 9,297 high-risk patients who had evidence of vascular disease or diabetes plus one other cardiovascular risk factor and who were not known to have a low ejection fraction or heart failure were randomly assigned to receive ramipril or matching placebo for a mean of five years. The primary outcome was a composite of myocardial infarction, stroke, or death from cardiovascular causes.
RESULTS:
A total of 4,645 patients were assigned to receive ramipril 10 mg daily and 4,652 were assigned to receive placebo. Of the patients taking ramipril, 650 patients reached the primary endpoint as compared with 826 patients who were assigned to receive placebo (p < 0.001). Treatment with ramipril reduced the rates of death from cardiovascular causes (6.1% vs. 8.1% in the placebo group, < 0.001), myocardial infarction (9.9% vs. 12.3%, p < 0.001), stroke (3.4% vs. 4.9%, p < 0.001) and death from any cause (10.4% vs. 12.2%, p = 0.005).
CONCLUSION:
Ramipril significantly reduces the rates of death, myocardial infarction, and stroke in a broad range of high-risk patients who are not known to have a low ejection fraction or heart failure.
Question:
From the abstract above, calculate the absolute risk reduction of the composite primary endpoint of myocardial infarction, stroke, or death from cardiovascular causes. (Round to the nearest TENTH. Put your answer in percentage form. Do not include the percentage sign when you type in the number.)
3.8
The absolute risk reduction is the absolute difference in outcome rates between two groups.
In biostatistics, what is meant by the mode in a group of values?
Answer
A
The value that corresponds to the 25th percentile
B
The value used to calculate the standard deviation of the mean
C
The value that occurs most frequently
D
When the values are stated numerically in order, it is the value half way down the list
E
The value that corresponds to the 95th percentile
C
The mode is the value that occurs most frequently.
Strongheart Study for Patients with NYHA Functional Class II-IV
BACKGROUND: Strongheart is a new drug being investigated for chronic heart failure patients.
METHODS: We enrolled 3,991 patients with chronic heart failure in New York Heart Association (NYHA) functional class II-IV and with an ejection fraction of 0.40 or less, stabilized on optimal standard therapy, in a double-blind, randomized controlled study. Randomization was preceded by a 2-week single-blind placebo run-in period. Of the 3,991 patients, 1,990 patients were randomly assigned to Strongheart 12.5 mg daily and 2,001 patients were assigned to placebo. The target dose was 200 mg once daily and doses were up-titrated over 8 weeks. Our primary endpoint was all-cause mortality, analyzed by intention to treat.
RESULTS: The study was stopped early on the recommendation of the independent safety committee. Mean follow-up time was 1 year. All-cause mortality was lower in the Strongheart group than in the placebo group (146 patient-deaths versus 219 patient-deaths; p = 0.00009, [95% CI 0.53-0.81]). There were fewer sudden deaths in the Strongheart group than in the placebo group (79 vs. 132; p = 0.0002) and deaths from worsening heart failure (30 vs 58; p = 0.0023).
CONCLUSIONS: Strongheart once daily in addition to optimal standard therapy improved survival.
From the abstract above, what is the relative risk reduction of the primary endpoint of all-cause mortality in patients randomized to the Strongheart group? (Round to the nearest WHOLE number. Put your answer in percentage form. Do not include the percentage sign when you type in the number.)
33
Relative risk reduction is defined as 1 minus relative risk. The relative risk is 0.67, so the relative risk reduction is 0.33 (1-0.67), or 33%.
Over 35,000 nurses were studied in a longitudinal study based in Framingham, Massachusetts. Each year, the nurses were followed up and asked to report on any incidence of heart disease. The researchers wanted to study incidence of heart disease in the subjects using hormone therapy versus those who did not use hormone therapy. Describe this type of study:
Answer
A
Controlled clinical trial
B
Meta analysis
C
Case control trial
D
Cohort study
E
Crossover analysis
D
A study group (the cohort) is followed over time and outcomes (the disease, or heart disease in this example) are compared to a subset of the group who were not exposed to an intervention, such as a drug. This example is prospective in design.
Choose the name of the term used to determine statistical significance in a trial:
Answer
A
The z-value
B
The T score
C
The p-value
D
The hazard ratio
E
The odds ratio
C
In most clinical trials, the statistical significance is defined as a p-value less than 0.05.
Abstract
BACKGROUND:
Angiotensin-converting-enzyme inhibitors improve the outcome among patients with left ventricular dysfunction, whether or not they have heart failure. We assessed the role of an angiotensin converting-enzyme inhibitor, ramipril, in patients who were at high risk for cardiovascular events but who did not have left ventricular dysfunction or heart failure.
METHODS:
A total of 9,297 high-risk patients who had evidence of vascular disease or diabetes plus one other cardiovascular risk factor and who were not known to have a low ejection fraction or heart failure were randomly assigned to receive ramipril or matching placebo for a mean of five years. The primary outcome was a composite of myocardial infarction, stroke, or death from cardiovascular causes.
RESULTS:
A total of 4,645 patients were assigned to receive ramipril 10 mg daily and 4,652 were assigned to receive placebo. Of the patients taking ramipril, 650 patients reached the primary endpoint as compared with 826 patients who were assigned to receive placebo (p < 0.001). Treatment with ramipril reduced the rates of death from cardiovascular causes (6.1% vs. 8.1% in the placebo group, p < 0.001), myocardial infarction (9.9% vs. 12.3%, p < 0.001), stroke (3.4% vs. 4.9%, p < 0.001) and death from any cause (10.4% vs. 12.2%, p = 0.005).
CONCLUSION:
Ramipril significantly reduces the rates of death, myocardial infarction, and stroke in a broad range of high-risk patients who are not known to have a low ejection fraction or heart failure.
Question:
From the abstract above, calculate the relative risk of the primary endpoint in the ramipril group compared to the placebo group.
Answer
0.79
The relative risk is the probability of the event occurring in the exposed group versus the non-exposed group. The risk of the primary outcome is 14% in the ramipril group versus 17.8% in the placebo group. 14%/17.8% gives a relative risk of 0.79.
Marital status (married, single, divorced) can be described as this type of data:
Answer
A
Ordinal
B
Nominal
C
Continuous
D
Random
E
Interval
Next
B
Discrete data can be divided into groups or categories (e.g., marital status, gender, ethnicity). These are called nominal discrete values.
Choose the name of the assertion that a clinical trial is designed to disprove which states there is no difference between two groups.
Answer
A
The assertive hypothesis
B
The null hypothesis
C
The alternative hypothesis
D
Type II error
E
The disclaimer
B
A clinical trial is testing the null hypothesis which states there is no difference between the two treatment groups.
A hospital pharmacist presents an article at journal club. She reports that the average weight of the subjects in the study is 172 pounds, with a standard deviation of 10. Choose the correct statement:
Answer
A
Most of the subjects had a weight within 5 pounds of the mean.
B
Most of the subjects had a weight within 10 pounds of the mean.
C
Most of the subjects weigh between 172-182 pounds.
D
Most of the subjects weigh between 162-172 pounds.
E
The mode of these data is 162 pounds.
B
The standard deviation (SD) shows how much variation there is from the average. For example, if the average weight in a study population is 172 pounds, with a SD of zero, then all subjects weigh the same (172 pounds). If the SD is 10, then roughly 68% of the subjects have a weight within 10 pounds of the mean (from 162 to 182 pounds).
What is the definition of a Type II error?
Answer
A
The clinical trial was not large enough to detect a meaningful difference between treatment groups.
B
The null hypothesis is true, but is rejected in error.
C
The null hypothesis is false, but it is rejected in error.
D
The null hypothesis is false, but is accepted in error.
E
The null hypothesis is true, but it is accepted in error.
D
A Type II error means that the null hypothesis is false, yet it is accepted in error. The study authors conclude that there is no difference, when there actually is a difference.
Blood pressure, hemoglobin A1C and LDL cholesterol can each be described as this type of data:
Answer
A
Ordinal
B
Nominal
C
Continuous
D
Random
E
Discrete
Next
C
Continuous variables can take an infinite number of possible values (within a range), such as height, weight, A1C, blood pressure. For example, a patient's A1C can be 7.2 or 7.3 or 7.4 and so on.
In a small, randomized, double-blind trial of a new treatment in patients with acute myocardial infarction, the mortality in the treated group was half that in the control group, but the difference was not significant. We can conclude that:
Answer
A
The inclusion and exclusion criteria were not appropriately defined to reach significance.
B
There is no point in continuing to develop the new treatment.
C
The reduction in mortality is so great that we should introduce the treatment immediately.
D
Cases should be added to the trial until the Normal test for comparison of two populations is significant.
E
The clinical trial may not have adequate statistical power.
E
The trial is small and some benefit was seen with the new treatment. Many times smaller studies are done to evaluate initial effects (many times referred to as pilot studies). Performing a larger trial will increase statistical power and may then show a statistically significant benefit.
A new drug for stroke prevention, CLOTBUST, was studied. The trial enrolled 2,546 patients. In the CLOTBUST arm, 39 out of 1,281 patients had a stroke compared with 64 patients out of 1,265 patients in the aspirin arm, p-value = 0.025. What was the relative risk of stroke in this trial?
0.6
The relative risk of stroke in this trial is calculated by taking the risk of stroke in each arm: 39/1,281 = 0.03 and 64/1,265 = 0.05. Therefore, 0.03/0.05 = 0.6.
A clinical trial evaluated the effects of a chemotherapeutic given to patients with osteosarcoma. The trial duration was three months and the primary endpoint was mortality. During this time, there were two deaths among patients receiving placebo and one death among patients receiving active drug with an equal amount of patients randomized to each arm. It could be stated that the drug decreased the risk of death by 50%. The "relative risk" of death in the placebo group was 2, or twice the amount in the drug group. The benefit sounds great, but in reality the benefit was very small. Choose the correct statements: (Select ALL that apply.)
Answer
A
The relative risk can be used to make a small benefit appear larger than is warranted.
B
Relative risk is also called the risk ratio.
C
An important feature of relative risk is that it tells you little about the actual risk outside the trial.
D
A relative risk > 1 means that fewer events are occurring in the treatment group compared to the control group.
E
A relative risk < 1 means that fewer events are occurring in the treatment group compared to the control group.
A,B,C,E
Relative risk (RR) gives you a measure of the risk of an event in one group compared to the risk of that event in a comparison group. It does not give you an idea of how important (or large) the treatment effect really is in the population-at-large.
A pharmacist is presenting the Helsinki trial which investigated gemfibrozil 1,200 mg daily versus control. The results showed that coronary heart disease (CHD) events were 2.7% in the gemfibrozil arm versus 4.1% in the control group, with a p-value of < 0.02. What is the relative risk of CHD events in this trial?
66%
The relative risk of CHD events in this trial is calculated by taking the risk of each arm: 2.7%/4.1% = 0.66, or 66%.
BACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin.
METHODS: In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause.
RESULTS: The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.28% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P < 0.001 for noninferiority; P = 0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P < 0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P = 0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P < 0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P = 0.42).
CONCLUSIONS: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.
From the abstract above, what is the absolute risk reduction of the primary outcome in patients receiving apixaban compared to warfarin? (Enter your answer as a percentage but do not enter the percentage sign.)
0.32%
The absolute risk reduction is the absolute difference in outcome rates between two groups. 1.6% - 1.28% = 0.32%.
The pharmacist is presenting a clinical trial to the medical team. The trial includes a 95% confidence interval for the primary endpoint. If the confidence interval was greater (98% or 99%), what effect will be seen with the interval?
Answer
A
The interval will be wider.
B
The interval will be more narrow.
C
There will be no effect on the interval.
D
The interval will no longer have valid meaning at a greater confidence level.
E
It will cause the p-value to be invalid.
A
Having a higher confidence interval will widen the interval. For example, 99% CIs are wider than 95% CIs. 95% CIs are wider than 90% CIs.
Abstract
BACKGROUND:
Although low-density lipoprotein (LDL) lowering has been the mainstay of therapy for primary and secondary cardiovascular (CV) prevention, the data have been primarily for statins. Other nonstatin agents such as fibrates, niacin, and high-density lipoprotein (HDL)-raising agents have failed to show a clinical benefit when added to statins. The current trial sought to study the safety and efficacy of ezetimibe/simvastatin compared with simvastatin alone in reducing CV events in patients at high risk.
METHODS:
Patients with recent ACS were randomized in a 1:1 fashion to either ezetimibe 10 mg/simvastatin 40 mg or simvastatin 40 mg in this placebo-controlled, randomized, double-blinded parallel study.
RESULTS:
A total of 18,144 patients were randomized at 1,158 sites in 39 countries, 9,067 to ezetimibe/simvastatin and 9,077 to simvastatin alone as part of the intention-to-treat group. Baseline characteristics were fairly similar between the two arms. Presentation was ST-segment elevation MI (STEMI) in 29%, NSTEMI in 47%, and unstable angina (UA) in 24%. Nearly 88% underwent diagnostic angiography and 70% underwent percutaneous coronary intervention. Premature discontinuation was observed in 42% of patients in both arms.
Baseline LDL cholesterol (LDL-C) levels were 95 mg/dL in both arms; the median follow-up average was 53.7 mg/dL versus 69.5 mg/dL in the ezetimibe/simvastatin and simvastatin arms, respectively. LDL lowering was observed as early as 1 month, and appeared sustained over the duration of follow-up. At 1 year, triglycerides were also lowered by 16.7 mg/dL in the combination arm, while HDL was increased by 0.6 mg/dL. The primary endpoint of CV death/MI/UA/coronary revascularization beyond 30 days/stroke was lower in the ezetimibe/simvastatin arm compared with the simvastatin arm over the duration of follow-up (32.7% vs. 34.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.89-0.99).
Other endpoints including MI (13.1% vs. 14.8%, p = 0.002), stroke (4.2% vs. 4.8%, p = 0.05), ischemic stroke (3.4% vs. 4.1%, p = 0.008), and CV death/MI/stroke (20.4% vs. 22.2%, p = 0.003) were all lower in the ezetimibe/simvastatin arm; no differences were noted for all-cause mortality (15.4% vs. 15.3%, p = 0.78), CV mortality (6.9% vs. 6.8%, p = 0.99) and need for coronary revascularization (21.8% vs. 23.4%, p = 0.11). Per protocol analysis confirmed and further embellished the primary intention-to-treat analyses; the primary endpoint was significantly reduced in the ezetimibe/simvastatin arm compared with placebo (29.8% vs. 32.4%, HR 0.92, 95% CI 0.87-0.98, p = 0.012).
Question:
What does "intention-to-treat" mean in this trial?
Answer
A
Chi-squared testing can be performed on the trial results.
B
All patients randomized in the trial were included in the analysis of the results.
C
Patients who took all doses of the medication were included in the analysis of the results.
D
Wilcoxon rank sum testing can be performed on the trial results.
E
The informed consent form was not signed by the study participant.
B
Intention-to-treat means all patients who were randomized were intended to be treated according to the study design. Some patients may elect to opt out of the study later on or the study protocol may not be followed exactly as stated, but these patients are still included in the results of the trial.
A randomized, open-label trial was conducted comparing Diovan to Altace. Patients were randomly assigned to either medication and the first dose must have been given on the same day the informed consent was signed. After 6 months, the results were analysed. Which of the following statements is true regarding this information?
Answer
A
The trial was not powered to detect a statistically significant difference.
B
The investigators were aware of which patients were on Altace or Diovan but the patients were not aware.
C
Patients had an equal chance of being assigned to either treatment regimen
D
Subjects had an equal chance of being chosen for study inclusion.
E
There will be no validity to the trial since patients had to signed an informed consent.
C
Randomization means that the enrolled subjects have an equal chance of being assigned one of the treatment regimens.
Which of the following statements regarding sensitivity are true? (Select ALL that apply.)
Answer
A
It refers to the percentage of time a test is negative when disease is not present.
B
It refers to the percentage of time a test is positive when disease is not present.
C
It refers to the percentage of time a test is negative when disease is present.
D
It refers to the percentage of time a test is positive when disease is present.
E
It is equal to 1 - type I error.
D
Pg. 168
A pharmacist is presenting the Helsinki trial which investigated gemfibrozil 1,200 mg daily versus control. The results showed that CHD events were 2.7% in the gemfibrozil arm versus 4.1% in the control group, with a p-value of < 0.02. What is the number needed to treat to prevent one CHD event in this trial?
72
Number needed to treat (NNT) is 1/ARR. Therefore, 1/0.014 = 72 patients. 72 patients will need to be treated with gemfibrozil to prevent one CHD event.
Next
A new diagnostic test detects a certain genetic marker linked to the development of breast cancer. The test has 79% sensitivity and 94% specificity. Which of the following statements are correct? (Select ALL that apply.)
Answer
A
This test will be positive 79% of the time in patients who have the breast cancer marker.
B
This test will be positive 94% of the time in patients who have the breast cancer marker.
C
This test will be negative 79% of the time in patients who have the breast cancer marker.
D
This test will be negative 94% of the time in patients who have the breast cancer marker.
E
This test will be able to detect 94% of the breast cancer cases in the United States.
A
Pg. 168
Abstract
BACKGROUND:
In patients with established cardiovascular disease, residual cardiovascular risk persists despite the achievement of target low-density lipoprotein (LDL) cholesterol levels with statin therapy. It is unclear whether extended-release niacin added to simvastatin to raise low levels of high-density lipoprotein (HDL) cholesterol is superior to simvastatin alone in reducing such residual risk.
METHODS:
We randomly assigned eligible patients to receive extended-release niacin, 1500 to 2000 mg per day, or matching placebo. All patients received simvastatin, 40 to 80 mg per day, plus ezetimibe, 10 mg per day, if needed, to maintain an LDL cholesterol level of 40 to 80 mg per deciliter (1.03 to 2.07 mmol per liter). The primary end point was the first event of the composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
RESULTS:
A total of 3414 patients were randomly assigned to receive niacin (1718) or placebo (1696). The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy. At 2 years, niacin therapy had significantly increased the median HDL cholesterol level from 35 mg per deciliter (0.91 mmol per liter) to 42 mg per deciliter (1.08 mmol per liter), lowered the triglyceride level from 164 mg per deciliter (1.85 mmol per liter) to 122 mg per deciliter (1.38 mmol per liter), and lowered the LDL cholesterol level from 74 mg per deciliter (1.91 mmol per liter) to 62 mg per deciliter (1.60 mmol per liter). The primary end point occurred in 282 patients in the niacin group and in 275 patients in the placebo group (p = 0.79).
Question:
In the trial above, what is the number needed to harm?
500
NNH is calculated the same way as NNT. ARR = 16.2 - 16.4 = -0.2% (implying risk from the treatment versus the placebo). NNH = 1/ARR (expressed as a decimal) = 1/0.002 = 500.
Abstract
BACKGROUND:
In patients with established cardiovascular disease, residual cardiovascular risk persists despite the achievement of target low-density lipoprotein (LDL) cholesterol levels with statin therapy. It is unclear whether extended-release niacin added to simvastatin to raise low levels of high-density lipoprotein (HDL) cholesterol is superior to simvastatin alone in reducing such residual risk.
METHODS:
We randomly assigned eligible patients to receive extended-release niacin, 1500 to 2000 mg per day, or matching placebo. All patients received simvastatin, 40 to 80 mg per day, plus ezetimibe, 10 mg per day, if needed, to maintain an LDL cholesterol level of 40 to 80 mg per deciliter (1.03 to 2.07 mmol per liter). The primary end point was the first event of the composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
RESULTS:
A total of 3414 patients were randomly assigned to receive niacin (1718) or placebo (1696). The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy. At 2 years, niacin therapy had significantly increased the median HDL cholesterol level from 35 mg per deciliter (0.91 mmol per liter) to 42 mg per deciliter (1.08 mmol per liter), lowered the triglyceride level from 164 mg per deciliter (1.85 mmol per liter) to 122 mg per deciliter (1.38 mmol per liter), and lowered the LDL cholesterol level from 74 mg per deciliter (1.91 mmol per liter) to 62 mg per deciliter (1.60 mmol per liter). The primary end point occurred in 282 patients in the niacin group and in 275 patients in the placebo group (p = 0.79).
Question:
In the trial above, what is the hazard ratio of the primary endpoint?
1.01
Hazard ratio (HR) = hazard rate in the treatment group / hazard rate in the control group. Hazard rate in the treatment group = 282/1718. Hazard rate in the control group = 275/1696. Therefore, 16.4/16.2 = 1.01.
Abstract
BACKGROUND:
A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period.
METHODS:
In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes.
RESULTS:
Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P < 0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P < 0.001).
CONCLUSIONS:
A once-yearly infusion of zoledronic acid during a 3-year period reduced the risk of vertebral, hip, and other fractures.
Question:
In the trial above, what is the absolute risk reduction of morphometric vertebral fractures?
7.6%
ARR = (% risk in control group) - (% risk in treatment group). Therefore, ARR = 10.9% - 3.3% = 7.6%.
A pharmacist is considering which intravenous vasodilator should be preferred at her institution. She has narrowed her search down to two agents. Each drug provides similar health benefits and similar tolerability. The pharmacist will base her decision on drug acquisition, administration, and monitoring costs. The pharmacist should use the following analysis to decide which intravenous vasodilator should be added to her institution:
Answer
A
A cost-utility analysis
B
A cost-minimization analysis
C
A cost-effectiveness analysis
D
A cost-benefit analysis
E
A cost-optimization analysis
B
A cost-minimization analysis (CMA) is used when two or more interventions have already demonstrated equivalency outcomes and the costs of each intervention are being compared. CMA measures and compares the input costs and assumes outcomes are equivalent.
Abstract
BACKGROUND:
A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period.
METHODS:
In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes.
RESULTS:
Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P < 0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P < 0.001).
CONCLUSIONS:
A once-yearly infusion of zoledronic acid during a 3-year period reduced the risk of vertebral, hip, and other fractures.
Question:
In the trial above, what is/are the independent variable/s? (Select ALL that apply.)
A
In a clinical trial, the independent variable is the intervention.
Which of the following statements regarding specificity are true? (Select ALL that apply.)
Answer
A
The percentage of time a test is negative when disease is not present.
B
The percentage of time a test is positive when disease is not present.
C
The percentage of time a test is negative when disease is present.
D
The percentage of time a test is positive when disease is present.
E
It is equal to 1 - type I error.
A, E
Pg. 168
Abstract
BACKGROUND:
Although low-density lipoprotein (LDL) lowering has been the mainstay of therapy for primary and secondary cardiovascular (CV) prevention, the data have been primarily for statins. Other nonstatin agents such as fibrates, niacin, and high-density lipoprotein (HDL)-raising agents have failed to show a clinical benefit when added to statins. The current trial sought to study the safety and efficacy of ezetimibe/simvastatin compared with simvastatin alone in reducing CV events in patients at high risk.
METHODS:
Patients with recent ACS were randomized in a 1:1 fashion to either ezetimibe 10 mg/simvastatin 40 mg or simvastatin 40 mg in this randomized, controlled, double-blinded parallel study.
RESULTS:
A total of 18,144 patients were randomized at 1,158 sites in 39 countries, 9,067 to ezetimibe/simvastatin and 9,077 to simvastatin alone as part of the intention-to-treat group. Baseline characteristics were fairly similar between the two arms. Presentation was ST-segment elevation MI (STEMI) in 29%, NSTEMI in 47%, and unstable angina (UA) in 24%. Nearly 88% underwent diagnostic angiography and 70% underwent percutaneous coronary intervention. Premature discontinuation was observed in 42% of patients in both arms.
Baseline LDL cholesterol (LDL-C) levels were 95 mg/dL in both arms; the median follow-up average was 53.7 mg/dL versus 69.5 mg/dL in the ezetimibe/simvastatin and simvastatin arms, respectively. LDL lowering was observed as early as 1 month, and appeared sustained over the duration of follow-up. At 1 year, triglycerides were also lowered by 16.7 mg/dL in the combination arm, while HDL was increased by 0.6 mg/dL. The primary endpoint of CV death/MI/UA/coronary revascularization beyond 30 days/stroke was lower in the ezetimibe/simvastatin arm compared with the simvastatin arm over the duration of follow-up (32.7% vs. 34.7%; p = 0.016).
Other endpoints including MI (13.1% vs. 14.8%, p = 0.002), stroke (4.2% vs. 4.8%, p = 0.05), ischemic stroke (3.4% vs. 4.1%, p = 0.008), and CV death/MI/stroke (20.4% vs. 22.2%, p = 0.003) were all lower in the ezetimibe/simvastatin arm; no differences were noted for all-cause mortality (15.4% vs. 15.3%, p = 0.78), CV mortality (6.9% vs. 6.8%, p = 0.99) and need for coronary revascularization (21.8% vs. 23.4%, p = 0.11). Per protocol analysis confirmed and further embellished the primary intention-to-treat analyses; the primary endpoint was significantly reduced in the ezetimibe/simvastatin arm compared with simvastatin (29.8% vs. 32.4%, HR 0.92, 95% CI 0.87-0.98, p = 0.012).
Question:
In the trial above, what is the number of people needed to treat to prevent 1 primary endpoint event in the per protocol population?
39
NNT = 1/ARR (expressed as a decimal). ARR = 32.4% - 29.8% = 2.6%. Therefore, NNT = 1/0.026 = 38.5. Round up to 39 for the correct response.
Abstract
BACKGROUND:
Although low-density lipoprotein (LDL) lowering has been the mainstay of therapy for primary and secondary cardiovascular (CV) prevention, the data have been primarily for statins. Other nonstatin agents such as fibrates, niacin, and high-density lipoprotein (HDL)-raising agents have failed to show a clinical benefit when added to statins. The current trial sought to study the safety and efficacy of ezetimibe/simvastatin compared with simvastatin alone in reducing CV events in patients at high risk.
METHODS:
Patients with recent ACS were randomized in a 1:1 fashion to either ezetimibe 10 mg/simvastatin 40 mg or simvastatin 40 mg in this randomized, controlled, double-blinded parallel study.
RESULTS:
A total of 18,144 patients were randomized at 1,158 sites in 39 countries, 9,067 to ezetimibe/simvastatin and 9,077 to simvastatin alone as part of the intention-to-treat group. Baseline characteristics were fairly similar between the two arms. Presentation was ST-segment elevation MI (STEMI) in 29%, NSTEMI in 47%, and unstable angina (UA) in 24%. Nearly 88% underwent diagnostic angiography and 70% underwent percutaneous coronary intervention. Premature discontinuation was observed in 42% of patients in both arms.
Baseline LDL cholesterol (LDL-C) levels were 95 mg/dL in both arms; the median follow-up average was 53.7 mg/dL versus 69.5 mg/dL in the ezetimibe/simvastatin and simvastatin arms, respectively. LDL lowering was observed as early as 1 month, and appeared sustained over the duration of follow-up. At 1 year, triglycerides were also lowered by 16.7 mg/dL in the combination arm, while HDL was increased by 0.6 mg/dL. The primary endpoint of CV death/MI/UA/coronary revascularization beyond 30 days/stroke was lower in the ezetimibe/simvastatin arm compared with the simvastatin arm over the duration of follow-up (32.7% vs. 34.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.89-0.99).
Other endpoints including MI (13.1% vs. 14.8%, p = 0.002), stroke (4.2% vs. 4.8%, p = 0.05), ischemic stroke (3.4% vs. 4.1%, p = 0.008), and CV death/MI/stroke (20.4% vs. 22.2%, p = 0.003) were all lower in the ezetimibe/simvastatin arm; no differences were noted for all-cause mortality (15.4% vs. 15.3%, p = 0.78), CV mortality (6.9% vs. 6.8%, p = 0.99) and need for coronary revascularization (21.8% vs. 23.4%, p = 0.11). Per protocol analysis confirmed and further embellished the primary intention-to-treat analyses; the primary endpoint was significantly reduced in the ezetimibe/simvastatin arm compared with simvastatin (29.8% vs. 32.4%, HR 0.92, 95% CI 0.87-0.98, p = 0.012).
Question:
In the trial above, what is the number of people needed to treat to prevent 1 primary endpoint event in the intention-to-treat population?
50
NNT = 1/ARR (expressed as a decimal). Therefore, NNT = 1/0.02 = 50.
Abstract
BACKGROUND:
Although trends in the prevalence of obesity and obesity-attributable deaths have been examined, little is known about the resultant burden of disease associated with obesity.
PURPOSE:
This study examined trends in the burden of obesity by estimating the obesity-related quality-adjusted life years (QALYs) lostâ€”defined as the sum of QALYs lost due to morbidity and future QALYs lost in expected life years due to premature deathsâ€”among U.S. adults along with differences by gender, race/ethnicity, and state.
Question:
What type of pharmacoeconomic analysis is this?
Answer
A
Cost-Minimization Analysis
B
Cost-Benefit Analysis
C
Cost-Effectiveness Analysis
D
Cost-Utility Analysis
E
ECHO Model Analysis
Next
D
Cost-utility analysis includes a quality of life component, generally expressed in quality-adjusted life years (QALYs). CUA considers both quality (morbidity) and quantity (mortality) of life gained.
Abstract
BACKGROUND:
In patients with established cardiovascular disease, residual cardiovascular risk persists despite the achievement of target low-density lipoprotein (LDL) cholesterol levels with statin therapy. It is unclear whether extended-release niacin added to simvastatin to raise low levels of high-density lipoprotein (HDL) cholesterol is superior to simvastatin alone in reducing such residual risk.
METHODS:
We randomly assigned eligible patients to receive extended-release niacin, 1500 to 2000 mg per day, or matching placebo. All patients received simvastatin, 40 to 80 mg per day, plus ezetimibe, 10 mg per day, if needed, to maintain an LDL cholesterol level of 40 to 80 mg per deciliter (1.03 to 2.07 mmol per liter). The primary end point was the first event of the composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
RESULTS:
A total of 3414 patients were randomly assigned to receive niacin (1718) or placebo (1696). The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy. At 2 years, niacin therapy had significantly increased the median HDL cholesterol level from 35 mg per deciliter (0.91 mmol per liter) to 42 mg per deciliter (1.08 mmol per liter), lowered the triglyceride level from 164 mg per deciliter (1.85 mmol per liter) to 122 mg per deciliter (1.38 mmol per liter), and lowered the LDL cholesterol level from 74 mg per deciliter (1.91 mmol per liter) to 62 mg per deciliter (1.60 mmol per liter). The primary end point occurred in 282 patients in the niacin group and in 275 patients in the placebo group (p = 0.79).
Question:
Looking at the results of the trial above, which of the following statements are correct? (Select ALL that apply.)
Answer
A
The addition of niacin to statin therapy did not lead to a clinically significant reduction in death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
B
The addition of niacin to statin therapy led to a statistically significant reduction in death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
C
The addition of niacin to statin therapy led to a clinically significant reduction in death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
D
The addition a statin to niacin therapy led to a statistically significant reduction in death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
E
The addition of a statin to niacin therapy did not lead to a clinically significant reduction in death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
A
The study was terminated early because there appeared to be a lack of efficacy. The primary end point occurred more often in the niacin group than the placebo group, but this was not statistically significant.
Which of the following situations best represents a Type I error?
Answer
A
A clinical trial investigating Drug X is found to be statistically significant and is approved for use by the FDA. A subsequent trial of the same inclusion and exclusion criteria with adequate statistical power is performed and is not found to be statistically significant.
B
A clinical trial investigating Drug X is found to be statistically significant and is approved for use by the FDA. A subsequent trial of the same inclusion and exclusion criteria and same number of patients is performed and is found to be statistically significant.
C
A clinical trial investigating Drug X is not found to be statistically significant. A subsequent trial of the same inclusion and exclusion criteria and same number of patients with adequate power is performed and is not found to be statistically significant.
D
A clinical trial investigating Drug X is not found to be statistically significant. A subsequent trial of the same inclusion and exclusion criteria with adequate power is performed and is found to be statistically significant.
E
A clinical trial investigating Drug X is found to be statistically significant and is approved for use by the FDA. A subsequent trial of the same inclusion and exclusion criteria with adequate power is performed and is found to be statistically significant.
A
A type I error occurs when when the null hypothesis is rejected in error. In the example, the first study had a statistically significant result. The investigator failed to accept (rejected) the null hypothesis. The subsequent study (with adequate power) had conflicting results. This is a type I error.
A cardiologist believes that atrial fibrillation may be caused by chronic exposure to zolpidem. He intends to conduct a study of patients at his current practice. He will select a group of patients with atrial fibrillation and a group of matched patients without atrial fibrillation. He will review the medical records of both groups looking for exposure to zolpidem. What type of study design does this trial represent?
Answer
A
Cross-sectional study
B
Case series
C
Case-control study
D
Cohort study
E
Case report
C
This is a case-control study design. Case-control studies start with patients who have the disease (and controls) and looks back retrospectively for an exposure. In this case the study starts with atrial fibrillation patients (and controls) and looks for exposure to zolpidem. If the cardiologist finds an association, a trial would need to be conducted to prove cause and effect.
A pharmacist is presenting the Helsinki trial which investigated gemfibrozil 1,200 mg daily versus control. The results showed that CHD events were 2.7% in the gemfibrozil arm versus 4.1% in the control group, with a p-value of < 0.02. What is the absolute risk reduction of CHD events in this trial? (Round to the nearest TENTH. Type in just the number; do not include the percentage sign in the answer.)
1.4
The absolute risk reduction is the difference in risk of the outcome in question (in this case, CHD events). The rate of CHD events in the control arm was 4.1%. The rate of CHD events in the gemifibrozil arm was 2.7%. 4.1% - 2.7% = 1.4%.
Abstract
BACKGROUND:
Although low-density lipoprotein (LDL) lowering has been the mainstay of therapy for primary and secondary cardiovascular (CV) prevention, the data have been primarily for statins. Other nonstatin agents such as fibrates, niacin, and high-density lipoprotein (HDL)-raising agents have failed to show a clinical benefit when added to statins. The current trial sought to study the safety and efficacy of ezetimibe/simvastatin compared with simvastatin alone in reducing CV events in patients at high risk.
METHODS:
Patients with recent ACS were randomized in a 1:1 fashion to either ezetimibe 10 mg/simvastatin 40 mg or simvastatin 40 mg in this placebo-controlled, randomized, double-blinded parallel study.
RESULTS:
A total of 18,144 patients were randomized at 1,158 sites in 39 countries, 9,067 to ezetimibe/simvastatin and 9,077 to simvastatin alone as part of the intention-to-treat group. Baseline characteristics were fairly similar between the two arms. Presentation was ST-segment elevation MI (STEMI) in 29%, NSTEMI in 47%, and unstable angina (UA) in 24%. Nearly 88% underwent diagnostic angiography and 70% underwent percutaneous coronary intervention. Premature discontinuation was observed in 42% of patients in both arms.
Baseline LDL cholesterol (LDL-C) levels were 95 mg/dL in both arms; the median follow-up average was 53.7 mg/dL versus 69.5 mg/dL in the ezetimibe/simvastatin and simvastatin arms, respectively. LDL lowering was observed as early as 1 month, and appeared sustained over the duration of follow-up. At 1 year, triglycerides were also lowered by 16.7 mg/dL in the combination arm, while HDL was increased by 0.6 mg/dL. The primary endpoint of CV death/MI/UA/coronary revascularization beyond 30 days/stroke was lower in the ezetimibe/simvastatin arm compared with the simvastatin arm over the duration of follow-up (32.7% vs. 34.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.89-0.99).
Other endpoints including MI (13.1% vs. 14.8%, p = 0.002), stroke (4.2% vs. 4.8%, p = 0.05), ischemic stroke (3.4% vs. 4.1%, p = 0.008), and CV death/MI/stroke (20.4% vs. 22.2%, p = 0.003) were all lower in the ezetimibe/simvastatin arm; no differences were noted for all-cause mortality (15.4% vs. 15.3%, p = 0.78), CV mortality (6.9% vs. 6.8%, p = 0.99) and need for coronary revascularization (21.8% vs. 23.4%, p = 0.11). Per protocol analysis confirmed and further embellished the primary intention-to-treat analyses; the primary endpoint was significantly reduced in the ezetimibe/simvastatin arm compared with simvastatin (29.8% vs. 32.4%, HR 0.92, 95% CI 0.87-0.98, p = 0.012).
Question:
Looking at the results of the trial above, what is the absolute risk reduction of the primary endpoint in the intention-to-treat population?
2%
ARR = (% risk in control group) - (% risk in treatment group). Therefore, ARR = 34.7% - 32.7% = 2%.
Abstract
BACKGROUND:
Although low-density lipoprotein (LDL) lowering has been the mainstay of therapy for primary and secondary cardiovascular (CV) prevention, the data have been primarily for statins. Other nonstatin agents such as fibrates, niacin, and high-density lipoprotein (HDL)-raising agents have failed to show a clinical benefit when added to statins. The current trial sought to study the safety and efficacy of ezetimibe/simvastatin compared with simvastatin alone in reducing CV events in patients at high risk.
METHODS:
Patients with recent ACS were randomized in a 1:1 fashion to either ezetimibe 10 mg/simvastatin 40 mg or simvastatin 40 mg in this randomized, controlled, double-blinded parallel study.
RESULTS:
A total of 18,144 patients were randomized at 1,158 sites in 39 countries, 9,067 to ezetimibe/simvastatin and 9,077 to simvastatin alone as part of the intention-to-treat group. Baseline characteristics were fairly similar between the two arms. Presentation was ST-segment elevation MI (STEMI) in 29%, NSTEMI in 47%, and unstable angina (UA) in 24%. Nearly 88% underwent diagnostic angiography and 70% underwent percutaneous coronary intervention. Premature discontinuation was observed in 42% of patients in both arms.
Baseline LDL cholesterol (LDL-C) levels were 95 mg/dL in both arms; the median follow-up average was 53.7 mg/dL versus 69.5 mg/dL in the ezetimibe/simvastatin and simvastatin arms, respectively. LDL lowering was observed as early as 1 month, and appeared sustained over the duration of follow-up. At 1 year, triglycerides were also lowered by 16.7 mg/dL in the combination arm, while HDL was increased by 0.6 mg/dL. The primary endpoint of CV death/MI/UA/coronary revascularization beyond 30 days/stroke was lower in the ezetimibe/simvastatin arm compared with the simvastatin arm over the duration of follow-up (32.7% vs. 34.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.89-0.99).
Other endpoints including MI (13.1% vs. 14.8%, p = 0.002), stroke (4.2% vs. 4.8%, p = 0.05), ischemic stroke (3.4% vs. 4.1%, p = 0.008), and CV death/MI/stroke (20.4% vs. 22.2%, p = 0.003) were all lower in the ezetimibe/simvastatin arm; no differences were noted for all-cause mortality (15.4% vs. 15.3%, p = 0.78), CV mortality (6.9% vs. 6.8%, p = 0.99) and need for coronary revascularization (21.8% vs. 23.4%, p = 0.11). Per protocol analysis confirmed and further embellished the primary intention-to-treat analyses; the primary endpoint was significantly reduced in the ezetimibe/simvastatin arm compared with placebo (29.8% vs. 32.4%, HR 0.92, 95% CI 0.87-0.98).
Question:
Looking at the results of the trial above, which of the following statements is correct?
Answer
A
Ezetimibe 10 mg/simvastatin 40 mg is not superior to simvastatin 40 mg alone in reducing CV events in post high-risk ACS patients.
B
Ezetimibe 10 mg/simvastatin 40 mg is superior to simvastatin 40 mg alone in reducing CV events in post high-risk ACS patients.
C
Ezetimibe 10 mg/simvastatin 40 mg is inferior to simvastatin 40 mg alone in reducing CV events in post high-risk ACS patients.
D
Ezetimibe 10 mg/simvastatin 40 mg is similar to simvastatin 40 mg alone in reducing CV events in post high-risk ACS patients.
E
There is no statistical difference between ezetimibe 10 mg/simvastatin 40 mg and simvastatin 40 mg alone in reducing CV events in post high-risk ACS patients.
B
Since the confidence interval for the hazard ratio does not include 1, the results for the primary endpoint are statistically significant at the 0.05 level. Please note, reporting of the p-value is not necessary to determine this.
Which of the following situations best represents a Type II error?
Answer
A
A clinical trial investigating Drug X is found to be statistically significant and is approved for use by the FDA. A subsequent trial of the same inclusion and exclusion criteria and same number of patients is performed and is not found to be statistically significant.
B
A clinical trial investigating Drug X is found to be statistically significant and is approved for use by the FDA. A subsequent trial of the same inclusion and exclusion criteria and same number of patients is performed and is found to be statistically significant.
C
A clinical trial investigating Drug X is not found to be statistically significant. A subsequent trial of the same inclusion and exclusion criteria and same number of patients with adequate power is performed and is not found to be statistically significant.
D
A clinical trial investigating Drug X is not found to be statistically significant. A subsequent trial of the same inclusion and exclusion criteria with adequate power is performed and is found to be statistically significant.
E
A clinical trial investigating Drug X is found to be statistically significant and is approved for use by the FDA. A subsequent trial of the same inclusion and exclusion criteria with adequate power is performed and is found to be statistically significant.
D
A type II error occurs when when the null hypothesis is accepted in error. In the example, the first study had a non-statistically significant result (no difference). The null hypothesis was accepted. The subsequent study (with adequate power) had conflicting results. This is a type II error. Type II error is more likely to occur in underpowered trials.
Which of the following statements are true regarding the p-value? (Select ALL that apply)
Answer
A
It indicates the likelihood of the study results being due to chance.
B
It represents the level of clinical significance.
C
It is considered statistatically significant if the p-value is less than the alpha value.
D
It provides information for accepting or not accepting the null hypothesis.
E
It can be set to any number by the investigator and be clinically relevant.
A, C, D
Generally a p-value of < 0.05 indicates statistical significance in a clinical trial. The p-value does not measure the clinical significance of the result.
Abstract
BACKGROUND:
Although low-density lipoprotein (LDL) lowering has been the mainstay of therapy for primary and secondary cardiovascular (CV) prevention, the data have been primarily for statins. Other nonstatin agents such as fibrates, niacin, and high-density lipoprotein (HDL)-raising agents have failed to show a clinical benefit when added to statins. The current trial sought to study the safety and efficacy of ezetimibe/simvastatin compared with simvastatin alone in reducing CV events in patients at high risk.
METHODS:
Patients with recent ACS were randomized in a 1:1 fashion to either ezetimibe 10 mg/simvastatin 40 mg or simvastatin 40 mg in this randomized, controlled, double-blinded parallel study.
RESULTS:
A total of 18,144 patients were randomized at 1,158 sites in 39 countries, 9,067 to ezetimibe/simvastatin and 9,077 to simvastatin alone as part of the intention-to-treat group. Baseline characteristics were fairly similar between the two arms. Presentation was ST-segment elevation MI (STEMI) in 29%, NSTEMI in 47%, and unstable angina (UA) in 24%. Nearly 88% underwent diagnostic angiography and 70% underwent percutaneous coronary intervention. Premature discontinuation was observed in 42% of patients in both arms.
Baseline LDL cholesterol (LDL-C) levels were 95 mg/dL in both arms; the median follow-up average was 53.7 mg/dL versus 69.5 mg/dL in the ezetimibe/simvastatin and simvastatin arms, respectively. LDL lowering was observed as early as 1 month, and appeared sustained over the duration of follow-up. At 1 year, triglycerides were also lowered by 16.7 mg/dL in the combination arm, while HDL was increased by 0.6 mg/dL. The primary endpoint of CV death/MI/UA/coronary revascularization beyond 30 days/stroke was lower in the ezetimibe/simvastatin arm compared with the simvastatin arm over the duration of follow-up (32.7% vs. 34.7%, p = 0.016).
Other endpoints including MI (13.1% vs. 14.8%, p = 0.002), stroke (4.2% vs. 4.8%, p = 0.05), ischemic stroke (3.4% vs. 4.1%, p = 0.008), and CV death/MI/stroke (20.4% vs. 22.2%, p = 0.003) were all lower in the ezetimibe/simvastatin arm; no differences were noted for all-cause mortality (15.4% vs. 15.3%, p = 0.78), CV mortality (6.9% vs. 6.8%, p = 0.99) and need for coronary revascularization (21.8% vs. 23.4%, p = 0.11). Per protocol analysis confirmed and further embellished the primary intention-to-treat analyses; the primary endpoint was significantly reduced in the ezetimibe/simvastatin arm compared with simvastatin (29.8% vs. 32.4%, p = 0.012).
Question:
In the trial above, what is the hazard ratio of the primary endpoint in the intention-to-treat population?
0.94
Hazard ratio (HR) = hazard rate in the treatment group/hazard rate in the control group. Therefore, HR = 32.7%/34.7% = 0.94. Hazard ratio is a type of relative risk.
Abstract
BACKGROUND:
Although low-density lipoprotein (LDL) lowering has been the mainstay of therapy for primary and secondary cardiovascular (CV) prevention, the data have been primarily for statins. Other nonstatin agents such as fibrates, niacin, and high-density lipoprotein (HDL)-raising agents have failed to show a clinical benefit when added to statins. The current trial sought to study the safety and efficacy of ezetimibe/simvastatin compared with simvastatin alone in reducing CV events in patients at high risk.
METHODS:
Patients with recent ACS were randomized in a 1:1 fashion to either ezetimibe 10 mg/simvastatin 40 mg or simvastatin 40 mg in this randomized, controlled, double-blinded parallel study.
RESULTS:
A total of 18,144 patients were randomized at 1,158 sites in 39 countries, 9,067 to ezetimibe/simvastatin and 9,077 to simvastatin alone as part of the intention-to-treat group. Baseline characteristics were fairly similar between the two arms. Presentation was ST-segment elevation MI (STEMI) in 29%, NSTEMI in 47%, and unstable angina (UA) in 24%. Nearly 88% underwent diagnostic angiography and 70% underwent percutaneous coronary intervention. Premature discontinuation was observed in 42% of patients in both arms.
Baseline LDL cholesterol (LDL-C) levels were 95 mg/dL in both arms; the median follow-up average was 53.7 mg/dL versus 69.5 mg/dL in the ezetimibe/simvastatin and simvastatin arms, respectively. LDL lowering was observed as early as 1 month, and appeared sustained over the duration of follow-up. At 1 year, triglycerides were also lowered by 16.7 mg/dL in the combination arm, while HDL was increased by 0.6 mg/dL. The primary endpoint of CV death/MI/UA/coronary revascularization beyond 30 days/stroke was lower in the ezetimibe/simvastatin arm compared with the simvastatin arm over the duration of follow-up (32.7% vs. 34.7%; p = 0.016).
Other endpoints including MI (13.1% vs. 14.8%, p = 0.002), stroke (4.2% vs. 4.8%, p = 0.05), ischemic stroke (3.4% vs. 4.1%, p = 0.008), and CV death/MI/stroke (20.4% vs. 22.2%, p = 0.003) were all lower in the ezetimibe/simvastatin arm; no differences were noted for all-cause mortality (15.4% vs. 15.3%, p = 0.78), CV mortality (6.9% vs. 6.8%, p = 0.99) and need for coronary revascularization (21.8% vs. 23.4%, p = 0.11). Per protocol analysis confirmed and further embellished the primary intention-to-treat analyses; the primary endpoint was significantly reduced in the ezetimibe/simvastatin arm compared with simvastatin (29.8% vs. 32.4%, HR 0.92, 95% CI 0.87-0.98, p = 0.012).
Question:
Which of the following statements is correct when referring to the primary endpoint's absolute risk reduction?
Answer
A
There is a 2% reduction in risk in all patients taking simvastatin.
B
There will be two less primary endpoint events for every 100 patients taking ezetimibe/simvastatin.
C
One hundred patients need to be treated with simvastatin for two patients to benefit.
D
There is a 98% reduction in risk in all patients taking ezetimibe/simvastatin.
E
There will be two less primary endpoint events for every 100 patients taking simvastatin.
B
The ARR for the primary endpoint is 2%.
Standard deviation represents:
Answer
A
The measurement of the difference of the highest and lowest values around the median.
B
The 5% of the numbers not contained within the confidence interval.
C
The measurement of the difference of the highest and lowest values around the mean.
D
The measure of the precision of the sample mean.
E
The variability of the data around the mean.
E
The standard deviation is a measure that summarizes the amount by which every value within a dataset varies from the mean.
Which of the following statements is true regarding statistical power of a study?
Answer
A
A trial without adequate statistical power is at risk of a type I error.
B
Higher statistical power results in more confidence that the null hypothesis was accepted correctly.
C
Risk of type II error can be eliminated if statistical power is high enough.
D
Statistical power and type II error are not related.
E
It is the probability of failing to accept the null hypothesis when it is false.
E
Risk of type I or type II error can never be completely eliminated. As power increases, the chance of type II error decreases.
A new study is presented on medical rounds. The clinical trial reports that Drug X was significantly better than aspirin in reducing heart attacks. The data is reported as normally distributed, with the average heart attack risk in the Drug X group of 2.4% versus 5.2% in the placebo group. What is the correct statement regarding the relationship between the mean, median and mode of this trial?
Answer
A
The mean of the data is the middle while the median is skewed to the left.
B
The mean of the data is the middle while the median is skewed to the right.
C
The mean, median and mode are the same value.
D
The median of the data is the middle while the mean is skewed to the left.
E
The median of the data is the middle while the mean is skewed to the right.
C
When the data are not skewed, the mean, median and mode are the same value, or are equal to one another.
A pharmacy administration resident will conduct a pharmaconeconomic study to evaluate the utility of the fluoroquinolone IV to oral interchange program for UTI at her institution. She will compare patients who had IV to oral interchange made by a pharmacist versus those who did not over a 12 month period. The outcomes that will be measured include length of stay (days) and percent of patients with clinical cure. Choose the type of analysis the pharmacy resident should perform:
Answer
A
Cost-Minimization Analysis
B
Cost-Benefit Analysis
C
Cost-Effectiveness Analysis
D
Cost-Utility Analysis
E
ECHO Model Analysis
C
CEA is the most common methodology in the literature today. Outcomes are similar to those in clinical trials, like the example above. Inputs are measured in dollars (pharmacist time, drug costs) and outputs are in natural units (cure, LOS).
What is the average in the following data set?
98, 45, 8, 57, 62, 89, 8, 49
52
The average (or mean) is calculated by adding all the values and diving by the number of values present.
A director of pharmacy for a large hospital employs two clinical coordinators. The director asked each clinical coordinator to submit a proposal for a new clinical program that could be implemented in the future that would improve patient care and reduce cost.
The Ambulatory Care clinical coordinator proposed rotating clinical pharmacists through the pulmonology clinic to focus on COPD patients with high readmission rates. The pharmacist would see patients with the team, review medication regimens, and provide patient counseling. An extra pharmacist would be needed 3 mornings per week, but he believes the service could decrease COPD readmission rates, improve prescribing, and improve patient satisfaction.
The Critical Care clinical coordinator proposed expanding the ICU prolonged infusion beta-lactam protocol to the entire hospital. The protocol is working well in the 25-bed ICU and costs have been reduced. Expanding to the entire hospital will require significant multidisciplinary education, since this would be a major practice change. It could further reduce drug expenditure, reduce antimicrobial resistance rates, and possibly reduce length of stay.
What type of pharmacoeconomic analysis would be best to determine which proposal would provide the most monetary benefit to department of pharmacy?
Answer
A
Cost-Minimization Analysis
B
Cost-Benefit Analysis
C
Cost-Effectiveness Analysis
D
Cost-Utility Analysis
E
ECHO Model Analysis
B
A cost-benefit analysis is useful for comparing programs with similar or unrelated (as in this example) outcomes as long as the outcome measures can be converted to dollars. Even antimicrobial resistance can be converted to dollars (resistant pathogens lead to more expensive antimicrobials being used and for longer durations). Certainly improving patient satisfaction is an important goal for a program, but the director of pharmacy will likely need to justify the program to his superiors in terms of dollars, with this as an additional benefit.
Abstract
BACKGROUND:
A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period.
METHODS:
In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes.
RESULTS:
Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P < 0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P < 0.001).
CONCLUSIONS:
A once-yearly infusion of zoledronic acid during a 3-year period reduced the risk of vertebral, hip, and other fractures.
Question:
In the trial above, which statement is accurate regarding the relative risk of morphometric vertebral fractures?
Answer
A
Patients taking zoledronic acid were 30% less likely to experience morphometric vertebral fractures than patients taking placebo.
B
Patients taking placebo were 30% less likely to experience morphometric vertebral fractures than patients taking zoledronic acid.
C
Patients taking zoledronic acid were 30% as likely to experience morphometric vertebral fractures than patients taking placebo.
D
Patients taking placebo were 30% as likely to experience morphometric vertebral fractures than patients taking zoledronic acid.
E
Patients taking zoledronic acid were 30% more likely to experience morphometric vertebral fractures than patients taking placebo.
C
The relative risk for morphometric vertebral fractures is 0.30 (10.9% in the placebo group vs 3.3% in the zoledronic acid group). The correct interpretation of the RR is that the patients who received zoledronic acid were 30% as likely to experience vertebral fracture as those taking placebo (not 30% less likely since 30% less than 10.9% is 7.63%).
Abstract
BACKGROUND:
A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period.
METHODS:
In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes.
RESULTS:
Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P < 0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P < 0.001).
CONCLUSIONS:
A once-yearly infusion of zoledronic acid during a 3-year period reduced the risk of vertebral, hip, and other fractures.
Question:
In reading the trial above, which of the following statements regarding the null hypothesis is true?
Answer
A
The null hypothesis should be accepted.
B
The null hypothesis should fail to be accepted.
C
The null hypothesis does not exist for this trial.
D
A decision regarding the null hypothesis cannot be made from the information provided.
E
None of the above statements are true.
B
For the outcomes of morphometric vertebral fracture and hip fracture, the difference between zoledronic acid and placebo was statistically significant. We know this because the 95% confidence intervals for each of the risk ratios exclude 1.
A new diagnostic test detects a certain genetic marker linked to the development of colon cancer. The test has 89% sensitivity and 82% specificity. Which of the following statements are correct? (Select ALL that apply.)
Answer
A
This test will be negative 89% of the time in patients who do not have the colon cancer marker.
B
This test will be positive 89% of the time in patients who have the colon cancer marker.
C
This test will be negative 82% of the time in patients who do not have the colon cancer marker.
D
This test will be positive 82% of the time in patients who have the colon cancer marker.
E
This test will be positive 89% of the time in patients who do not have the colon cancer marker.
B, C
Pg. 168
Abstract
BACKGROUND:
A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period.
METHODS:
In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes.
RESULTS:
Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P < 0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P < 0.001).
CONCLUSIONS:
A once-yearly infusion of zoledronic acid during a 3-year period reduced the risk of vertebral, hip, and other fractures.
Question:
In the trial above, what is/are the dependent variable/s? (Select ALL that apply.)
Answer
A
Vertebral fractures
B
Zoledronic acid
C
Placebo
D
Hip fractures
E
Cost of the medication
Next
A, D
In a clinical trial, the dependent variable/s are the outcome/s of interest.
What is the median in the following data set?
78, 34, 2, 11, 103, 88, 6, 212
56
For an even number of values: arrange the numbers in order from lowest to highest, select the middle two numbers, add them together and divide by 2.
A report of a clinical trial of a new antipyretic (Feverstop) versus placebo, concluded that the new drug gave a higher proportion of success than did the placebo. The alpha value of the trial was reported to be 0.05. The report ended with the statement that Feverstop was associated with a 15% risk reduction in fever which was statistically significant (p-value = 0.03). In light of this information, we may conclude:
Answer
A
The likelihood the reduction in fever was due to chance is 3%.
B
The likelihood the confidence interval contained 15% is 3%.
C
We are 97% confident the true value for fever reduction is 15%.
D
We can expect the same results 97 out of 100 times if this trial was repeated.
E
The likelihood of a type II error is 3%.
A
The p-value is the probability the result was due to chance. The likelihood that the reduction in fever was due to chance is 3%.
A company recently learned that several lots of their popular coffee creamer were contaminated with a human carcinogen. It is unknown what effect consuming this carcinogen in small quantities may have on humans. An immediate recall is announced. A massive media campaign is underway to identify people who used these lots of coffee creamer so they can receive medical attention immediately. The company plans to conduct a study that will follow these patients over time to determine the effect of this exposure compared to other patients who used their coffee creamer who were not exposed. What study design does this trial represent?
Answer
A
Cross-sectional study
B
Case series
C
Case-control study
D
Cohort study
E
Case report
D
This is a prospective cohort study design. Cohort studies start with an exposure/intervention and look for an outcome of interest (disease). In this case the study starts with the exposure (contaminated coffee creamer) and patients will be followed prospectively to look for an outcome (disease such as cancer). This design is useful when randomization to the exposure would be unethical.
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