Randomised controlled trials in general practice PhD course at the Norwegian research school in General Practice

11.04.14. EOR

Randomised controlled trials in general practice

PhD course at the Norwegian research school in General Practice

This course addresses methods in performing randomised controlled trials in general practice with a special emphasize on cluster randomised trials. Students will develop an understanding of how to plan, implement, analyze, report and evaluate RCTs. Original research will be presented by principal investigators, followed by discussions of papers with focus on design options and analytic strategies. The lectures will provide methodological background and will cover applied issues typically encountered in studies in general practice. This course is intended primarily for PhD students in general practice. The course includes a qualification in Good Clinical Practice (GCP) for studies in a general practice setting.

Aim: To give insight in how to perform RCTs in a general practice setting.

Learning outcomes: At the end of the course the students will be able to

1. describe how to plan, implement, analyze, report and evaluate RCTs 2. write an outline of a research protocol for RCT in a general practice setting Course team:

Prof. Elin Olaug Rosvold (EOR), Prof. Jørund Straand (JS), Svein Gjelstad (SG), MD, PhD, Prof. Morten Lindbæk (ML)

Lecturers: Ingvild Vik (IV), MD, Kirsten Valebjørg Knudsen (KVK), MD,

Eirik Eliassen (KEE) MD, Espen Saxhaug Kristoffersen (SEK) MD, PhD (All from University of Oslo).

External lecturer: Professor Sandra Eldridge (SE), Queen Mary University of London

Language: Norwegian and English (SE)

Number of participants: 40. Open course. Priority: NAFALM students . Study points: 4 ECTS

Location: University of Oslo

Time: Every second year. First course 3-5 November 2014.

Randomised controlled trials in general practice

Location: University of Oslo, Time: 3-5 . November 2014

Monday 3.11 Tuesday 4.11 Wednesday 5.11

09.00 – 9.45 Part 3: Cluster randomised trials

Lecture 7: Design of cluster randomised trials 1. SE

Lecture 14: Complex intervention in general practice: Rx-PAD study. SG + JS

10.00 –10.30 Registration Lecture 8: Design of cluster randomised trials 2. SE

Lecture 15: Example of RCT in general practice: Epicondylitis study.

ML 10:30-11:15 Part 1: Planning

Lecture 1: RCT in general practice.

Possibilities and challenges. JS

Group session 2: Discussion of cluster randomised trials

(EOR et al)

Group session 3:

Complex interventions in general practice

(EOR et al) 11:15-12:00 Lecture 2: Overview of data sources

and data collection. Power calculation.

Registration. SG

12:00- 13:00 LUNCH LUNCH LUNCH

13.00 –13:45 Lecture 3:

Protocol. SG

Part 4: Good Clinical Practice (GCP) in a general practice setting.

Lecture 9: Planning a GCP IS

Part 5: Reporting

Lecture 16: Analyses. Statistical methods. SG

14.00–14:45 Lecture 4: RCT design in general practice. Example: Ibuprofen vs mecillinam for uncomplicated cystitis.

IV, ML

Lecture 10: Implementation of a GCP IS

Lecture 17:

Analyses. Statistical methods. SG

15.00 –15:45 Part 2: Implementation Lecture 5 : Recruitments of participants. Randomization.

Interventions. Data capture. SG

Lecture 11: GCP finalization IS Lecture 18 Writing a RCT paper.

Choice of Journal. JS, SG

16.00 –16:45 Lecture 6: Organizing RCT . Example:

Vitamin D study. KVK

Lecture 12: Examples of RCT:

Comparing 3 antibiotic regimes for erythema migrans in general practice.

KEE

Lecture 19: Discussion JS and EOR

17:00-18:00 Group session 1: Discussion of RCT papers (EOR et al)

Lecture 13: Medication overuse headache. ESK

19:00

Dinner

Home tasks, Compulsory reading and Examination

Home task group session 1

Home task group session 2 and GCP

Home task group session 3

Examination

Read papers 1-3. Study text book.

Ruyter et al (ref. 8).

Read papers 4-7. Write an outline of a research protocol for a RCT- study in general practice (max 2 pages).

Compulsory reading

Text book: Sandra Eldridge and Sally Kerry: A practical Guide to Cluster Ramdomised Trials in Health Services Research (278 pages)

1. Knutsen KV. Madar AA. Lagerlov P. Brekke M. Raastad T. Stene LC. Meyer HE. Does vitamin D improve muscle strength in adults? A randomized, double-blind, placebo-controlled trial among ethnic minorities in Norway . J Clin Endocrinol Metab. 99(1):194-202, 2014 Jan

2. Kristoffersen ES. Straand J. Benth JS. Russell MB. Lundqvist C. Study protocol: brief intervention for medication overuse headache--a double-blinded cluster randomised parallel controlled trial in primary care. BMC Neurology. 12:70, 2012. (12 pages)

3. Sturt J. Hearnshaw H. Farmer A. Dale J. Eldridge S. The Diabetes Manual trial protocol - a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411]. BMC Family Practice. 7:45, 2006. (8 pages)

4. Straand J. Fetveit A. Rognstad S. Gjelstad S. Brekke M. Dalen I. A cluster-randomized educational intervention to reduce inappropriate prescription patterns for elderly patients in general practice--The Prescription Peer Academic Detailing (Rx-PAD) study [NCT00281450]. BMC Health Services Research. 6:72, 2006. (10 pages)

5. Gjelstad S. Hoye S. Straand J. Brekke M. Dalen I. Lindbaek M. Improving antibiotic prescribing in acute respiratory tract infections: cluster randomised trial from Norwegian general practice (prescription peer academic detailing (Rx-PAD) study). BMJ. 347:f4403, 2013. (12 pages)

6. Olaussen M. Holmedal O. Lindbaek M. Brage S. Physiotherapy alone or in combination with corticosteroid injection for acute lateral epicondylitis in general practice: a protocol for a randomised, placebo-controlled study. BMC Musculoskeletal Disorders. 10:152, 2009. (8 p)

7. Schulz KF. Grimes DA. Multiplicity in randomised trials II: subgroup and interim analyses. Lancet. 365(9471):1657-61, 2005 May 7-13.

8. Ruyter KW, Førde R, Solbakk, JH.. Medisinsk og helsefaglig etikk. Gyldendal Akademisk 2014. ISBN: 978-82-05-46110-9, p. 211-233 and 245-255 (32 pages)