Clinical Research

1. Clinical Research Professor Hanne Tønnesen

2. Contents • Best evidence based practice • Background • The randomized trials • Example • Evidence: score for level and quality • Patient preferences • Example

3. Best Evidence Staff expertise Patient preference Best Evidence-Based HP Includes all three parts (Sackett, DL, Strauss SE, Richardson WS et al. Evidence-based medicine. Churcill Livingstone 2000)

4. Best Evidence-Based HP Best available evidence • Clinical relevant, patient focused research concerning • diagnostic • prognosis • treatment • care • health promotion • disease prevention • Rehabilitation • New evidence replaces earlier accepted procedures by new, more effective with less side-effects

5. + Quality Meta-analysesSyst reviews RCT (intervention) CCT (intervention) Cohorts, Case-Control studies (Obs) Cases (Obs) Editorial papers and Consensus (’GOBSAT’) Animal Studies In Vitro studies Evidence degree: Pyramid (Eccles M BMJ 1998)

6. Smoking before surgery (OBS) Conclusion It is very dangerous to stop smoking less than 8 weeks before surgery ! (i.e. it is better to recommend cont smoking instead of risking more complications) (DO Warner Anaest 1984)

7. Postop complications (RCT) 6-8 wks, knee and hip replacement surgery Møller et al: Lancet 2002 1-2 wks, colorectal resection Sørensen et al. Colorect Dis 2003 3-4 wks, gall bladder, herniation, knee and hip surgery Lindström et al. Ann Surg 2008

8. Møller SørensenLindström DO Warner Evidence degree: Pyramid Meta-analysesSyst reviews RCT (intervention) CCT (intervention) Cohorts, Case-Control studies (Obs) Cases (Obs) Editorial papers and Consensus (’GOBSAT’) Animal Studies In Vitro studies

9. Effect upon postop compl6-8 weeks intervention before knee / hip replacement AM Møller et al. Lancet 2002

10. Møller Sørensen Lindström Moller 2002 Evidence degree: Pyramid Meta-analysesSyst reviews RCT (intervention) CCT (intervention) Cohorts, Case-Control studies (Obs) Cases (Obs) Editorial papers and Consensus (’GOBSAT’) Animal Studies In Vitro studies

11. Another exampleThe history of peptic ulcer intervention • Previously • Egg, milk and biscuits + major surgery • Antacida + selective surgery • H-2 Blockers and Inhibiters of the proton-pump + super-selective surgery • Today • Eradiation of Helicobacter + emergency surgery, exclusively • To morrow ?

12. Quality: RCT • Commonly utilized methods • Two researchers read and evaluate. • In case of disagreement a third researcher makes the decision. • Many different point score systems • Some invented for the occasion • Few validated Forskningstræning 2009

13. Quality: RCT • How to balance different shortcomings? • Better to describe each shortcoming individually • But this does not solve the problem of balancing

14. Quality: RCT • Evaluation of • Research question (and if it is answered) • Material / Trial profile • In- and exclusion criteria • Patient characteristics: are the groups comparable • Trial profile: has account been made of all included patients, number of drop-outs, >80% completeness

15. Quality: RCT • Evaluation of • Randomization • Hidden randomization list? • Envelopes sealed, intransparant, continously numbered? • Blinding of patient / doctor, blinded follow-up / analyses ? • Results: ITT or per protocol (only the completed) • Outcomes

16. Best Evidence-Based HP Clinical expertise • Use of clinical expertise and experiences in relation to • intervention • meet the patients’ needs and wishes

17. Clinical expertise The influence of especially trained nurses 100 + 100 Emergency patients (smokers and alcohol abusers) • 47 of 100 accepted when offered brief intervention by the staff nurses • 97 of 100 accepted when offered BI by an experienced nurse from another department Nelbom et al 2004, Backer et al 2007

18. Especially trained nurses • Smokers and alcohol abusers from the emergency wards accepted BI • 97 / 100 from dept internal medicine • 121 / 200 from orthopaedic department • 68 / 100 from dept neurology • Quit rates • 30 to 50% stopped smoking and alcohol abuse for a period • 5 to 10% stopped for at least a year Nelbom et al 2004, Backer et al 2007, Tonnesen et al 2008 submitted

19. Best Evidence-Based HP Patient preferences • Individual preferences, wishes and expectations from each patient contacting a health care system

20. Patient experiences Being offered a 6-8 weeks preop program before knee or hip replacement therapy All would like to have the program offered Quitters Smokers Møller & Villebroe Ugeskr Laeger 2004

21. Patient experiences Being offered a few days preop program before breast cancer surgery All found it relevant Most: Insufficient in the present situation A few: The kick I needed Thomsen et al. 2009 Eur J Oncol Nurs

22. Patient experiences Being randomised to the control group instead of the 4+4 weeks intervention program in relation to general and hip/knee surgery Half of the patients were disappointed Lindström et al. Contemp Clin Trials 2009

23. Alcohol cessation int. Colorectal Resection Smoking cessation int. Hip/Knee Replacement Physical exercise int. Spine Surgery Postop recovery (BMC Health Serv Res 2008) Postop complications (BMJ 1999) Postop complications (Lancet 2002) Ex: High compliance in surgical settings

24. Contents • Best evidence based practice • Background • The randomized trials • Example • Evidence: score for level and quality • Patient preferences • Example