Pragmatic vs. explanatory: An adaptation of the PRECIS tool helps to judge the applicability of systematic reviews for daily practice

Journal of Clinical Epidemiology

Volumn 64, Issue 10, 2011, Pages 1095-1101

  Koppenaal, Tjarco ^a,b   Linmans, Joris ^a   Knottnerus, J André ^a   Spigt, Mark ^a  

^a MAASTRICHT UNIVERSITY   (Netherlands)

^b Foundation of Primary Health Care Centres Eindhoven   (Netherlands)

Author keywords

Clinical trial methodology; Lifestyle intervention; Policy making; Pragmatic trial; Randomized controlled trials; Systematic review

Indexed keywords

CALCULATION; PRAGMATIC EXPLANATORY CONTINUUM INDICATOR SUMMARY TOOL; PRIORITY JOURNAL; REVIEW; SCORING SYSTEM; STATISTICAL ANALYSIS; SYSTEMATIC REVIEW (TOPIC);

CLINICAL TRIALS AS TOPIC; DECISION SUPPORT TECHNIQUES; RESEARCH DESIGN; REVIEW LITERATURE AS TOPIC;

EID: 80052023039     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2010.11.020     Document Type: Review

References (44)

1. D. Schwartz, and J. Lellouch Explanatory and pragmatic attitudes in therapeutical trials J Chronic Dis 20 1967 637 648
2. R.B. Haynes, D.L. Sackett, and G.H. Guyatt Clinical epidemiology: how to do clinical practice research 2006 Lippincott, Williams and Wilkins Philadelphia, PA
3. K.E. Thorpe, M. Zwarenstein, A.D. Oxman, S. Treweek, C.D. Furberg, and D.G. Altman A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers J Clin Epidemiol 62 2009 464 475
4. D.L. Riddle, R.E. Johnson, M.P. Jensen, F.J. Keefe, K. Kroenke, and M.J. Bair The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) instrument was useful for refining a randomized trial design: experiences from an investigative team J Clin Epidemiol 63 2010 1271 1275
5. A. Liberati, D.G. Altman, J. Tetzlaff, C. Mulrow, P.C. Gøtzsche, and J.P. Ioannidis The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration J Clin Epidemiol 62 2009 e1 e34
6. A. Laupacis, and S. Straus Systematic reviews: time to address clinical and policy relevance as well as methodological rigor Ann Intern Med 147 2007 273 274 (Pubitemid 351664584)
7. R.J. McKinlay, C. Cotoi, N.L. Wilczynski, and R.B. Haynes Systematic reviews and original articles differ in relevance, novelty, and use in an evidence-based service for physicians: PLUS project J Clin Epidemiol 61 2008 449 454 (Pubitemid 351446186)
8. P. Fleming, and M. Godwin Lifestyle interventions in primary care: systematic review of randomized controlled trials Can Fam Physician 54 2008 1706 1713
9. C.S. Wiysonge, H. Bradley, B.M. Mayosi, R. Maroney, A. Mbewu, and L.H. Opie Beta-blockers for hypertension Cochrane Database Syst Rev 1 2007 CD002003
10. G. Salkeld, P. Phongsavan, B. Oldenburg, M. Johannesson, P. Convery, and P. Graham-Clarke The cost-effectiveness of a cardiovascular risk reduction program in general practice Health Policy 41 2 1997 105 119 (Pubitemid 27321959)
11. J.A. Baron, R. Gleason, B. Crowe, and J.I. Mann Preliminary trial of the effect of general practice based nutritional advice Br J Gen Pract 40 1990 137 141
12. M.J. Kastarinen, P.M. Puska, M.H. Korhonen, J.N. Mustonen, V.V. Salomaa, and J.E. Sundvall Non-pharmacological treatment of hypertension in primary health care: a 2-year open randomized controlled trial of lifestyle intervention against hypertension in eastern Finland J Hypertens 20 2002 2505 2512 (Pubitemid 36026864)
13. OXCHECK Effectiveness of health checks conducted by nurses in primary care: final results of the OXCHECK study. Imperial Cancer Research Fund OXCHECK Study Group BMJ 310 1995 1099 1104
14. C.R. Elley, N. Kerse, B. Arroll, and E. Robinson Effectiveness of counselling patients on physical activity in general practice: cluster randomised controlled trial BMJ 326 2003 793
15. A. Steptoe, S. Doherty, E. Rink, S. Kerry, T. Kendrick, and S. Hilton Behavioural counselling in general practice for the promotion of healthy behaviour among adults at increased risk of coronary heart disease: randomised trial BMJ 319 1999 943 947 discussion 947-8 (Pubitemid 29469387)
16. P. Roderick, V. Ruddock, P. Hunt, and G. Miller A randomized trial to evaluate the effectiveness of dietary advice by practice nurses in lowering diet-related coronary heart disease risk Br J Gen Pract 47 1997 7 12 (Pubitemid 27033854)
17. VACOOP Comparison of propranolol and hydrochlorothiazide for the initial treatment of hypertension. II. Results of long-term therapy. Veterans Administration Cooperative Study Group on Antihypertensive Agents JAMA 248 1982 2004 2011
18. VACOOP Comparison of propranolol and hydrochlorothiazide for the initial treatment of hypertension. I. Results of short-term titration with emphasis on racial differences in response. Veterans Administration Cooperative Study Group on Antihypertensive agents JAMA 248 1982 1996 2003
19. IPPPSH The international prospective primary prevention study in hypertension (IPPPSH): objectives and methods. The IPPPSH Collaborative Group Eur J Clin Pharmacol 27 1984 379 391
20. IPPPSH Cardiovascular risk and risk factors in a randomized trial of treatment based on the beta-blocker oxprenolol: the International Prospective Primary Prevention Study in Hypertension (IPPPSH). The IPPPSH Collaborative Group J Hypertens 3 1985 379 392
21. MRC MRC trial of treatment of mild hypertension: principal results. Medical Research Council Working Party Br Med J (Clin Res Ed) 291 6488 1985 97 104
22. MRCOA Medical Research Council trial of treatment of hypertension in older adults: principal results. MRC Working Party BMJ 304 1992 405 412
23. UKPDS-39 Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. UK Prospective Diabetes Study Group BMJ 317 1998 713 720
24. UKPDS-38 Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group BMJ 317 1998 703 713
25. G. Berglund, O. Andersson, and B. Widgren Low-dose antihypertensive treatment with a thiazide diuretic is not diabetogenic. A 10-year controlled trial with bendroflumethiazide Acta Med Scand 220 1986 419 424 (Pubitemid 17232389)
26. J. Coope, and T.S. Warrender Randomised trial of treatment of hypertension in elderly patients in primary care Br Med J (Clin Res Ed) 293 6555 1986 1145 1151 (Pubitemid 16008923)
27. B. Dahlof, R. Devereux, U. de Faire, F. Fyhrquist, T. Hedner, and H. Ibsen The Losartan Intervention For Endpoint reduction (LIFE) in Hypertension study: rationale, design, and methods. The LIFE Study Group Am J Hypertens 10 7 Pt 1 1997 705 713 (Pubitemid 27313815)
28. B. Dahlof, R.B. Devereux, S.E. Kjeldsen, S. Julius, G. Beevers, and U. de Faire Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol Lancet 359 2002 995 1003 (Pubitemid 34286536)
29. B. Dahlof, P.S. Sever, N.R. Poulter, H. Wedel, D.G. Beevers, and M. Caulfield Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial Lancet 366 2005 895 906 (Pubitemid 41265663)
30. C.J. Pepine, E.M. Handberg, R.M. Cooper-DeHoff, R.G. Marks, P. Kowey, and F.H. Messerli A calcium antagonist vs a non-calcium antagonist hypertension treatment strategy for patients with coronary artery disease. The International Verapamil-Trandolapril Study (INVEST): a randomized controlled trial JAMA 290 2003 2805 2816 (Pubitemid 37509488)
31. C.J. Pepine, E. Handberg-Thurmond, R.G. Marks, M. Conlon, R. Cooper-DeHoff, and P. Volkers Rationale and design of the International Verapamil SR/Trandolapril Study (INVEST): an Internet-based randomized trial in coronary artery disease patients with hypertension J Am Coll Cardiol 32 1998 1228 1237 (Pubitemid 28522378)
32. P.S. Sever, B. Dahlöf, N.R. Poulter, H. Wedel, G. Beevers, and M. Caulfield Rationale, design, methods and baseline demography of participants of the Anglo-Scandinavian Cardiac Outcomes Trial. ASCOT investigators J Hypertens 19 2001 1139 1147 (Pubitemid 32493649)
33. L. Wilhelmsen, G. Berglund, D. Elmfeldt, T. Fitzsimons, H. Holzgreve, and J. Hosie Beta-blockers versus diuretics in hypertensive men: main results from the HAPPHY trial J Hypertens 5 1987 561 572
34. J.T. Wright Jr., G. Bakris, T. Greene, L.Y. Agodoa, L.J. Appel, and J. Charleston Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial JAMA 288 2002 2421 2431 (Pubitemid 35340538)
35. J.T. Wright Jr., J.W. Kusek, R.D. Toto, J.Y. Lee, L.Y. Agodoa, and K.A. Kirk Design and baseline characteristics of participants in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study Control Clin Trials 17 4 Suppl 1996 3S 16S (Pubitemid 26343150)
36. A. Zanchetti Prevalence of carotid atherosclerosis in hypertension: preliminary baseline data from the European Lacidipine Study on Atheroscelerosis (ELSA) Blood Press Suppl 4 1996 30 35 (Pubitemid 26418432)
37. A. Zanchetti, M.G. Bond, M. Hennig, A. Neiss, G. Mancia, and C. Dal Pal Calcium antagonist lacidipine slows down progression of asymptomatic carotid atherosclerosis: principal results of the European Lacidipine Study on Atherosclerosis (ELSA), a randomized, double-blind, long-term trial Circulation 106 2002 2422 2427 (Pubitemid 35278796)
38. K.F. Schulz, D.G. Altman, and D. Moher CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials J Clin Epidemiol 63 2010 834 840
39. M. Zwarenstein, S. Treweek, J.J. Gagnier, D.G. Altman, S. Tunis, and B. Haynes Improving the reporting of pragmatic trials: an extension of the CONSORT statement BMJ 337 2008 a2390
40. P.J. Karanicolas, V.M. Montori, P.J. Devereaux, H. Schünemann, and G.H. Guyatt A new "mechanistic-practical" framework for designing and interpreting randomized trials J Clin Epidemiol 62 2009 479 484
41. S. Treweek, and M. Zwarenstein Making trials matter: pragmatic and explanatory trials and the problem of applicability Trials 10 2009 37
42. G. Gartlehner, R.A. Hansen, D. Nissman, K.N. Lohr, and T.S. Carey A simple and valid tool distinguished efficacy from effectiveness studies J Clin Epidemiol 59 2006 1040 1048 (Pubitemid 44374310)
43. D.L. Sackett The principles behind the tactics of performing therapeutic trials R.B. Haynes, D.L. Sackett, G.H. Guyatt, P. Tugwell, Clinical epidemiology: how to do clinical practice research 3rd edition 2006 Lippincott, Williams and Wilkins Philadelphia, PA 173 244
44. M.G. Spigt, and D. Kotz Comment on: "a simple and valid tool distinguished efficacy from effectiveness studies" J Clin Epidemiol 60 2007 753 755 (Pubitemid 46894727)