Evidence Appraisal Integrated Activities

OBJECTIVE

To critically appraise studies, develop a brief synopsis of the trial results, succinctly present the results and then put the results into a proper clinical context

INITIAL PRE-READING

How To Critically Appraise an RCT In 10 minutes

Watch this video Viva La Evidence

Study Results at Your Fingertips

MyStudies - Free access

INTEGRATION ACTIVITY FORMAT

Students placed in groups of ~ 5-7
Each group chooses one of the studies below to review
Students then work in pairs and develop a one-slide critical appraisal and results synopsis
One to two students in each group will be chosen at random to present their findings to the class
A discussion about the appraisal and the appropriate clinical context for the results is had with the entire class for each study

MODULE

TRIAL PRESENTATION FORMAT

Studies chosen include landmark studies and/or studies that address important therapeutic issues for the particular module

ACADEMIC YEAR 1 - FIRST TERM

1) FOUNDATION STUDIES (Groups)

ACCORD FIBRATES Groups 1,13,25
AFFIRM Groups 2,14,26
AIM-HIGH Groups 3,15,27
HOPE Groups 4,16,28
HYVET Groups 5,17,29
PROVE-IT Groups 6,18,30
TNT Groups 7,19,31
EMPAREG Groups 8,20,32
ILLUMINATE Groups 9,21,33
SPRINT Groups 10,22,34
CARDS Groups 11,23,35
WHI Groups 12,24,36

ACADEMIC YEAR 1 - SECOND TERM

2) INTRO TO INFECTIOUS DISEASE STUDIES

The "Best" Antibiotic Sensitivity Chart Ever

IV vs PO antibiotics Groups 1,13,25
Delayed antibiotics for respiratory tract infections Groups 2,14,26
Delayed antibiotics for otitis media Groups 3,15,27
Duration of treatment for community acquired pneumonia Groups 4,16,28
Duration of treatment for pyelonephritis Groups 5,17,29
Choice of antibiotic for community acquired pneumonia-1 Groups 6,18,30
Choice of antibiotic for community acquired pneumonia-2 Groups 7,19,31
HPV vaccine study Groups 8,20,32
Influenza vaccine study Groups 9,21,33
COVID vaccine Pfizer Groups 10,22,34
Herpes zoster vaccine study 1 Groups 11,23,35
Herpes zoster vaccine study 3 Groups 12,24,36

3) MUSCULOSKELETAL STUDIES

Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis Groups 1,13,25
CLASS – celecoxib vs NSAIDs Groups 2,14,26
Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for low back pain Groups 3,15,27
Glucosamine and chondroitin for OA Groups 4,16,28
Acetaminophen vs diclofenac for OA Groups 5,17,29
Diclofenac gel for acute neck pain Groups 6,18,30
Topical diclofenac vs oral diclofenac Groups 7,19,31
Acetaminophen for low back pain Groups 8,20,32
Misoprostol and NSAID induced ulcers Groups 9,21,33
Low dose vs high dose colchicine for gout Groups 10,22,34
TEAR - oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis Groups 11,23,35
MOVES - Glucosamine and chondroitin for OA for moderate to severe pain Groups 12,24,36

4) DERMATOLOGY STUDIES

5) EENT STUDIES

AMSTAR meta-analysis checklist

Scenario 1 - Otitis Media - GROUPS 1, 7, 18, 19, 25, 36

Anthony Martin arrives at your pharmacy somewhat frustrated since his family physician declined to write an antibiotic prescription for his two and half year old son, Oscar. His symptoms started yesterday afternoon - Oscar complains of right ear pain but there is no discharge. Rectal temperature taken today was 38.5 degrees. His wife is sure Oscar has an ear infection since the last time he had these same symptoms, that was ultimately the diagnosis. Mr. Martin asks if you think buying acetaminophen is really “enough”?

Antibiotics for acute otitis media in children

Scenario 2 - Allergic Rhinitis - GROUPS 2, 8, 17, 20, 26, 35

Ruby Parmar is a firefighter. She is plagued by sinus congestion (preventing her from sleeping) and a runny nose associated with seasonal allergies. Her prescription for intranasal triamcinolone is typically effective, but she would like to know if a non-sedating anti-allergy pill would work just as well since it’s inconvenient carrying around the “nose spray”.

Intranasal steroids vs antihistamines for allergic rhinitis

Scenario 3 - Acute Sinusitis - GROUPS 3, 9, 16, 21, 27, 34

You are seeing a patient in clinic before her appointment with the primary care physician. She was feeling unwell with a “flu” last week. While most of her symptoms have resolved (cough, fever), the nasal congestion and discharge persists and so she has made an appointment (she is an otherwise healthy 32 year old with treated thyroid disease). She would like your advice for what treatment she should ask the doctor to prescribe.

Intranasal steroids for acute sinusitis

Scenario 4 - Glaucoma - GROUPS 4, 10, 15, 22, 28, 33

Mrs. Ada Waters is a 63 year-old woman you. Her ophthalmologist prescribed timolol and xalatan eye drops for treatment of open angle glaucoma. She has never really felt much different on treatment since she recovered from her first episode (of acute angle closure glaucoma requiring ER visit) and surgery. She asks you if the treatment is really making a difference.

Interventions for open angle glaucoma

Scenario 5 - Sore Throat - GROUPS 5, 11, 14, 23, 29, 32

You have a good friend who is applying for pharmacy. Her invitation for the multiple-mini interview (MMI) is coming up soon, but she is starting to experience a sore throat. While she is worried about not being able to speak through all of those stations, she knows she often gets a terrible headache along with her sore throat. She has an unused prescription for amoxicillin (unexpired) and wonders if you recommend for her to take it.

Antibiotics for sore throat

Scenario 6 - Conjunctivitis - GROUPS 6, 12, 13, 24, 30, 31

A man comes to your pharmacy (he appears in his early twenties) complaining of “pink eye”. He has had a pink discolouration and discharge from his left eye for two days. He asks if the OTC antibiotic eye drops (he’s holding a product with polymixin B) are any better than “waiting it out”.

Antibiotics for acute conjunctivitis

6) HEMATOLOGY STUDIES

None so far

ACADEMIC YEAR 2 - FIRST TERM

7) RESPIROLOGY STUDIES

First inhaled steroid study Groups 1,13,25
Tiotropium in asthma Groups 2,14,26
Inhaled steroid in children Groups 3,15,27
Combined Budesonide–Formoterol as Needed in Mild Asthma Groups 4,16,28
Doubling dose of inhaled corticosteroid Groups 5,17,29
As-Needed Budesonide–Formoterol versus Maintenance Budesonide in Mild Asthma Groups 6,18,30
Indacaterol-glycopyrronium VS salmeterol/fluticasone in COPD Groups 7,19,31
Tiotropium VS salmeterol in COPD Groups 8,20,32
Short VS long steroids for COPD exacerbation Groups 9,21,33
Stopping inhaled steroids in COPD Groups 10,22,34
Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD Groups 11,23,35
Tezepelumab in Adults with Uncontrolled Asthma Groups 12,24,36

8) CARDIOVASCULAR STUDIES

SESSION 1

VA1 (Group 1, 13, 25)
VA 2 (Group 2, 14, 26)
Polycap Study 3 (Group 3, 15, 27)
ACCORD-BP (Group 4, 16, 28)
SPRINT (Group 5, 17, 29)
CONSENSUS (Group 6,18,30)
DAPA-HF (Group 7, 19, 31)
CONFIRM-HF (Group 8, 20, 32)
PROSPER (Group 9, 21, 33)
HOPE-3 (Group 10, 22, 34)
Heart Protection Study (HPS) (Group 11, 23, 35)
REDUCE-IT (Group 12, 24, 36)

File:CV Case.pdf

SESSION 2

The Guideline Case

A 63 y/o patient with CHOOSE ONE (⬆︎HTN/⬆︎Chol/⬆︎glucose/HF/A fib) and using the guideline determine:

their 5yr/10yr risks of mortality/CVD events
the potential benefit
the potential side effects (with magnitude)
words/sentiment patient values and preferences/SDM

Atrial fibrillation - Groups 1,13,25,2,14,26

2018 Atrial fibrillation guidelines

Diabetes - Groups 3,15,27,4,16,28

2018 Diabetes guidelines

Lipid Simplified - Groups 5,17,29,6,18,30

2015 Simplified lipid guidelines

Lipid - Groups 7,19,31,8,20,32

2016 Lipid guidelines

Heart failure - Groups 9,21,33,10,22,34

2017 Heart failure guidelines

Hypertension - Groups 11,23,35,12,24,36

2018 Hypertension guidelines

OPTIONAL SESSION

ACADEMIC YEAR 2 - SECOND TERM

9) NEPHROLOGY STUDIES

None so far

10) ENDOCRINOLOGYFile:IA ENDO LAYOUT 1.pdf

RISK ASSESSMENT CASES FOR DIABETES AND OSTEOPOROSIS

1) DIABETES CASE

66 y/o white male who was diagnosed with diabetes 8 years ago

His blood pressure over the last year has been roughly 145/80 mmHg - at present untreated
A1c = 8%, no diabetes meds, non-smoker, BMI ~30
Total cholesterol is 6 mmol/L, his HDL is 2 mmol/L, non-HDL = 6 minus 2, not on a statin
No retinopathy, urine albumin-to-creatinine ratio (UACR) = 15ug/mg (7mg/mmol),
Serum creatinine = 70 micromol/L, waist circumference 100 cm
GFR 75 mL/min/1.73m2
In normal sinus rhythm
Age at end of highest education = 19
Mother alive, father died of a heart attack at age 80

Calculate Risks

CVD RISK ESTIMATES - list the endpoints described by the specific calculator

Framingham - xx% - 10-year risk - also if no diabetes xx%

ASCVD - xx% - 10-year risk - also if no diabetes xx%

The Calculator

CVD CALCULATOR

https://decisionaid.ca/cvd/

DIABETES COMPLICATIONS RISK ESTIMATES - list the endpoints described by the specific calculator

xx% - also 10-year risk if A1c 9, 8, 7 and 6

also get risk of kidney failure, vision loss, pressure sensation loss – also if A1c 9, 8,7,6

The Calculator

DIABETES DECISION AID

http://decisionaid.ca/diabetes/

BENEFITS AND HARMS

Use the 2020 diabetes guidelines and/or Diabetes Decision Aid to get estimates of benefits and harms and also use the MyStudies synopsis listed below

COSTS

Try using Pricing Doc to get costs

Groups 1,13,25

Metformin - UKPDS 34 MyStudies Data

Groups 2,14,26

Sulfonlyureas - UKPDS 33 MyStudies Data

Groups 3,15,27

Insulin - ORIGIN MyStudies Data

Groups 4,16,28

SGLT2 - EMPA-REG OUTCOME MyStudies Data

Groups 5,17,29

GLP - LEADER MyStudies Data

Groups 6,18,30

DPP4 - TECOS MyStudies Data

Groups 7,19,31

Intensive treatment – small scale - STENO MyStudies Data

Groups 8,20,32

Intensive treatment – large scale - ADDITION-Europe - MyStudies Data

2) OSTEOPOROSIS CASE

60 y/o female

72 kg, 1.69m, BMI = 25.2
t-score of -2.5
Worried about falling and getting a hip fracture
A friend recently had an atraumatic fracture from simply tripping and falling over in the snow
No other risk factors

Calculate Risks

FRACTURE RISK ESTIMATES - list the endpoints described by the specific calculator

Major osteoporotic fracture - xx% - 10-year risk – if no BMD (just BMI), and then if they had a BMD t-Score of -2.0, -2.5, and -3.0

Hip fracture - - xx% - 10-year risk – if no BMD (just BMI) and if you have a BMD xx% - 10-year risk – if no BMD, and then if they had a BMD T-Score of -2.0, -2.5, and -3.0

The Calculator

FRACTURE CALCULATOR

Frax Tool - Canada

BENEFITS AND HARMS

Use the 2023 Osteoporosis Guideline and/or your osteoporosis lecture notes to get the benefits and apply these to your patient, and also get the harms

COSTS

Try using Pricing Doc to get costs

Groups 9,21,33

Activity

Groups 10,22,34

Calcium/Vitamin D

Groups 11,23,35

Bisphosphonates

Groups 12,24,36

Denosumab

11) NEUROLOGY STUDIES

Opioids for chronic non-cancer pain Groups 1,13,25
Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain Groups 2,14,26
Galcanezumab for prevention of cluster headaches Groups 3,15,27
Immediate or delayed treatment of a first seizure Groups 4,16,28
Rimegepant for episodic migraine Groups 5,17,29
Sleep restriction for insomnia Groups 6,18,30
CHANCE Groups 7,19,31
SPARCL Groups 8,20,32
Erenumab for episodic migraine Groups 9,21,33
Reduction of benzodiazepines through education Groups 10,22,34
Patient controlled opioid analgesia versus non-patient controlled opioid analgesia for postoperative pain Groups 11,23,35
PROGRESS Groups 12,24,36

ACADEMIC YEAR 3

12) PSYCHIATRY STUDIES

Psychiatry Rating Scales Introduction

Study 1: STAR*D (Level 2) Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression
Study 2: Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder
Study 3: Long-acting injectable versus oral antipsychotics for the maintenance treatment of schizophrenia
Study 4: Association of Antipsychotic Polypharmacy vs Monotherapy With Psychiatric Rehospitalization Among Adults With Schizophrenia
Study 5: Real-world Effectiveness of Pharmacologic Treatments for the Prevention of Bipolar Disorder
Study 6: BALANCE Combination lithium and valproate therapy versus monotherapy for relapse prevention in bipolar I disorder

13) GASTROENTEROLOGY STUDIES

Fidaxomicin versus vancomycin for Clostridium difficile infection Groups 1,13,25
Prophylaxis of hepatic encephalopathy: Lactulose vs placebo Groups 2,14,26
Antibiotics vs surgical therapy for uncomplicated appendicitis: Systematic review and meta-analysis Groups 3,15,27
Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics Groups 4,16,28
Omeprazole before endoscopy in patients with gastrointestinal bleeding Groups 5,17,29
Sequential-therapy treatment regimens vs standard triple therapy for the eradication of H. pylori infection Groups 6,18,30
Adding licorice to the standard treatment regimen of Helicobacter pylori Groups 7,19,31
Palifermin for oral mucositis after intensive therapy for hematologic cancers Groups 8,20,32
Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: a meta-analysis Groups 9,21,33
Prevention of NSAID-induced gastroduodenal ulcers: a meta-analysis Groups 10,22,34
Beta-Adrenergic Antagonists in the Prevention of Gastrointestinal Rebleeding in Patients With Cirrhosis: A Meta-Analysis Groups 11,23,35
Rifaximin versus norfloxacin for secondary prophylaxis of spontaneous bacterial peritonitis Groups 12,24,36

14) OB/GYN STUDIES