Rating of Included Trials on the Efficacy–Effectiveness Spectrum: development of a new tool for systematic reviews

Journal of Clinical Epidemiology

Volumn 84, Issue , 2017, Pages 95-104

  Wieland, L Susan ^a   Berman, Brian M ^a   Altman, Douglas G ^b   Barth, Jürgen ^c   Bouter, Lex M ^d,e   D'Adamo, Christopher R ^a   Linde, Klaus ^f   Moher, David ^g,h   Mullins, C Daniel ⁱ   Treweek, Shaun ^j   Tunis, Sean ^k   van der Windt, Danielle A ^l   Zwarenstein, Merrick ^m   Witt, Claudia ^a,c,n  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^e VU UNIVERSITY AMSTERDAM   (Netherlands)

^f TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^g OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^h UNIVERSITY OF OTTAWA   (Canada)

ⁱ UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^j UNIVERSITY OF ABERDEEN   (United Kingdom)

^k World Trade Center   (United States)

^l KEELE UNIVERSITY   (United Kingdom)

^m WESTERN UNIVERSITY   (Canada)

ⁿ CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

more..

Author keywords

Applicability; Comparative effectiveness research; Effectiveness; Efficacy; Explanatory trial; Pragmatic trial; Randomized controlled trials; Systematic reviews

Indexed keywords

ARTICLE; AUTHOR; CITATION ANALYSIS; CLINICAL EFFECTIVENESS; CLINICAL RESEARCH; CORRELATION COEFFICIENT; DELPHI STUDY; DEMOGRAPHY; FEASIBILITY STUDY; HUMAN; INTERRATER RELIABILITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RATING SCALE; STATISTICAL PARAMETERS; SYSTEMATIC REVIEW (TOPIC); COMPARATIVE EFFECTIVENESS; EPIDEMIOLOGY; LITERATURE; OBSERVER VARIATION; PROCEDURES; REPRODUCIBILITY; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME;

COMPARATIVE EFFECTIVENESS RESEARCH; DELPHI TECHNIQUE; EPIDEMIOLOGIC RESEARCH DESIGN; FEASIBILITY STUDIES; HUMANS; OBSERVER VARIATION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; REVIEW LITERATURE AS TOPIC; TREATMENT OUTCOME;

EID: 85016498254     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2017.01.010     Document Type: Article

References (21)

1. Schwartz, D., Lellouch, J., Explanatory and pragmatic attitudes in therapeutical trials. J Clin Epidemiol 62 (2009), 499–505.
2. Thorpe, K.E., Zwarenstein, M., Oxman, A.D., Treweek, S., Furberg, C.D., Altman, D.G., et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol 62 (2009), 464–475.
3. Loudon, K., Treweek, S., Sullivan, F., Donnan, P., Thorpe, K.E., Zwarenstein, M., The PRECIS-2 tool: designing trials that are fit for purpose. BMJ, 350, 2015, h2147.
4. Witt, C.M., Manheimer, E., Hammerschlag, R., Ludtke, R., Lao, L., Tunis, S.R., et al. How well do randomized trials inform decision making: systematic review using comparative effectiveness research measures on acupuncture for back pain. PLoS One, 7(2), 2012, e32399.
5. Koppenaal, T., Linmans, J., Knottnerus, J.A., Spigt, M., Pragmatic vs. explanatory: an adaptation of the PRECIS tool helps to judge the applicability of systematic reviews for daily practice. J Clin Epidemiol 64 (2011), 1095–1101.
6. Glasgow, R.E., Gaglio, B., Bennett, G., Jerome, G.J., Yeh, H.C., Sarwer, D.B., et al. Applying the PRECIS criteria to describe three effectiveness trials of weight loss in obese patients with comorbid conditions. Health Serv Res 47 (2012), 1051–1067.
7. Selby, P., Brosky, G., Oh, P.I., Raymond, V., Ranger, S., How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial. BMC Med Res Methodol, 12, 2012, 101.
8. Tosh, G., Soares-Weiser, K., Adams, C.E., Pragmatic vs explanatory trials: the pragmascope tool to help measure differences in protocols of mental health randomized controlled trials. Dialogues Clin Neurosci 13 (2011), 209–215.
9. Bratton, D.J., Nunn, A.J., Wojnarowska, F., Kirtschig, G., Sandell, A., Williams, H.C., The value of the pragmatic-explanatory continuum indicator summary wheel in an ongoing study: the bullous pemphigoid steroids and tetracyclines study. Trials, 13, 2012, 50.
10. Thorpe, K.E., Zwarenstein, M., Oxman, A.D., Treweek, S., Furberg, C.D., Altman, D.G., et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ 180 (2009), E47–E57.
11. Zwarenstein, M., Treweek, S., Gagnier, J.J., Altman, D.G., Tunis, S., Haynes, B., et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ, 337, 2008, a2390.
12. Loudon, K., Zwarenstein, M., Sullivan, F., Donnan, P., Treweek, S., Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose. Trials, 14, 2013, 115.
13. Institute of Medicine. What is comparative effectiveness research?. Initial National Priorities for Comparative Effectiveness Research, 2009, 29 The National Academies Press, Washington D.C.
14. Gartlehner, G., Hansen, R.A., Nissman, D., Lohr, K.N., Carey, T.S., A simple and valid tool distinguished efficacy from effectiveness studies. J Clin Epidemiol 59 (2006), 1040–1048.
15. Roland, M., Torgerson, D.J., What are pragmatic trials?. BMJ, 316, 1998, 285.
16. Bratton, D.J., Nunn, A.J., Alternative approaches to tuberculosis treatment evaluation: the role of pragmatic trials. Int J Tuberc Lung Dis 15 (2011), 440–446.
17. Wider, B., Pittler, M.H., Thompson-Coon, J., Ernst, E., Artichoke leaf extract for treating hypercholesterolaemia. Cochrane Database Syst Rev, 3, 2013, CD003335.
18. Panebianco, M., Sridharan, K., Ramaratnam, S., Yoga for epilepsy. Cochrane Database Syst Rev, 5, 2015, CD001524.
19. Manheimer, E., Cheng, K., Linde, K., Lao, L., Yoo, J., Wieland, S., et al. Acupuncture for peripheral joint osteoarthritis. Cochrane Database Syst Rev, 2010, CD001977.
20. Linde, K., Allais, G., Brinkhaus, B., Fei, Y., Mehring, M., Vertosick, E.A., et al. Acupuncture for the prevention of episodic migraine. Cochrane Database Syst Rev, 2016, CD001218.
21. Shrout, P.E., Fleiss, J.L., Intraclass correlations: uses in assessing rater reliability. Psychol Bull 86 (1979), 420–428.