Protocol for CONSORT-SPI: An extension for social and psychological interventions

Implementation Science

Volumn 8, Issue 1, 2013, Pages

  Montgomery, Paul ^a   Grant, Sean ^a   Hopewell, Sally ^b   Macdonald, Geraldine ^c   Moher, David ^d   Michie, Susan ^e   Mayo Wilson, Evan ^e  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

^d OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^e UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Complex interventions; CONSORT SPI; Randomised controlled trial; RCT; Reporting guidelines

Indexed keywords

ARTICLE; DELPHI STUDY; HEALTH PROMOTION; HUMAN; METHODOLOGY; PRACTICE GUIDELINE; PROGRAM EVALUATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARD;

DELPHI TECHNIQUE; GUIDELINES AS TOPIC; HEALTH PROMOTION; HUMANS; PROGRAM EVALUATION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 84883183918     PISSN: None     EISSN: 17485908     Source Type: Journal    
DOI: 10.1186/1748-5908-8-99     Document Type: Article

References (51)

1. Medical Research Council A framework for development and evaluation of RCTs for complex interventions to improve health 2008, London: MRC, Medical Research Council.
2. Hayward RA, Kent DM, Vijan S, Hofer TP. Reporting clinical trial results to inform providers, payers, and consumers. Health Aff 2005, 24(6):1571-1581.
3. Glasziou P, Chalmers I, Altman DG, Bastian H, Boutron I, Brice A, et al. Taking healthcare interventions from trial to practice. BMJ 2010, 341:384-387.
4. Schulz KF, Altman DG, Moher D, for the CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:698-702. for the CONSORT Group.
5. Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004, 328:702-708. 10.1136/bmj.328.7441.702, 381234, 15031246.
6. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, , et al. for the CONSORT and Pragmatic Trials in Healthcare (Practihc) group Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008, 337:a2390. 10.1136/bmj.a2390, 3266844, 19001484, for the CONSORT and Pragmatic Trials in Healthcare (Practihc) group.
7. Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148:295-309. 10.7326/0003-4819-148-4-200802190-00008, 18283207, for the CONSORT group.
8. Moher D, Weeks L, Ocampo M, Seely D, Sampson M, Altman DG, et al. Describing reporting guidelines for health research: a systematic review. J Clin Epidemiol 2011, 64(7):718-742. 10.1016/j.jclinepi.2010.09.013, 21216130.
9. Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med 2010, 7(2):e1000217. 10.1371/journal.pmed.1000217, 2821895, 20169112.
10. Moher D, Jones A, Lepage L, for the CONSORT Group Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 2001, 285:1992-1995. 10.1001/jama.285.15.1992, 11308436, for the CONSORT Group.
11. Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev 2012, 11:MR000030.
12. Torgerson CJ, Torgerson DJ, Birks YF, Porthouse J. A comparison of RCTs in health and education. Br Educ Res J 2005, 31(6):761-785.
13. Stinson JN, McGrath PJ, Yamada JT. Clinical trials in the journal of pediatric psychology: applying the CONSORT statement. J Pediatr Psychol 2003, 28:159-167. 10.1093/jpepsy/jsg001, 12654939.
14. Perry AE, Weisburd D, Hewitt C. Are criminologists describing randomized controlled trials in ways that allow us to assess them? findings from a sample of crime and justice trials. J Exp Criminol 2010, 6:245-262.
15. Naleppa MJ, Cagle JG. Treatment fidelity in social work intervention research: a review of published studies. Res Soc Work Pract 2010, 20:674-681.
16. Semaan S, Kay L, Strouse D, Sogolow E, Mullen PD, Neumann MS, et al. A profile of U.S.-based trials of behavioral and social interventions for HIV risk reduction. J Acquir Immune Defic Syndr 2002, 30:S30-S50.
17. Grant S, Mayo-Wilson E, Melendez-Torres GJ, Montgomery P. The reporting quality of social and psychological intervention trials: a systematic review of reporting guidelines and trial publications. PLoS One 2013, 8(5):e65442. 10.1371/journal.pone.0065442, 3666983, 23734256.
18. McGrath PJ, Stinson J, Davidson K. Commentary: the journal of pediatric psychology should adopt the CONSORT statement as a way of improving the evidence base in pediatric psychology. J Pediatr Psychol 2003, 28:169-171. 10.1093/jpepsy/jsg002, 12654940.
19. Davidson KW, Goldstein M, Kaplan RM, Kaufmann PG, Knatterud GL, Orleans CT, et al. Evidence-based behavioural medicine: what is it and how do we achieve it?. Ann Behav Med 2003, 26:161-171. 10.1207/S15324796ABM2603_01, 14644692.
20. Armstrong R, Waters E, Moore L, Riggs E, Cuervo LG, Lumbiganon P, et al. Improving the reporting of public health intervention research: advancing TREND and CONSORT. J Public Health (Oxf) 2008, 30(1):103-109.
21. Bonell C, Oakley A, Hargreaves J, Strange V, Rees R. Assessment of generalisability in trials of health interventions: suggested framework and systematic review. BMJ 2006, 333:346-349. 10.1136/bmj.333.7563.346, 1539056, 16902217.
22. Moore L, Moore GF. Public health evaluation: which designs work, for whom and under what circumstances?. J Epidemiol Community Health 2011, 65:596-597. 10.1136/jech.2009.093211, 21665866.
23. Boutron I, John P, Torgerson DJ. Reporting methodological items in randomized experiments in political science. Ann Am Acad Pol Soc Sci 2010, 628(112):112-131.
24. Simera I, Altman DG, Moher D, Schulz KF, Hoey J. Guidelines for reporting health research: the EQUATOR network's survey of guideline authors. PLoS Med 2008, 5:869-874.
25. Hopewell S, Altman DG, Moher D, Schulz KF. Endorsement of the CONSORT statement by high impact factor medical journals: a survey of journal editors and journal 'instructions to authors. Trials 2008, 9:20. 10.1186/1745-6215-9-20, 2359733, 18423021.
26. Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006, 144:364-367. 10.7326/0003-4819-144-5-200603070-00013, 16520478.
27. Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group Methods and processes of the CONSORT group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med 2008, 148(4):W60-W67. for the CONSORT group.
28. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, for the CONSORT PRO Group Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 2013, 309(8):814-822. 10.1001/jama.2013.879, 23443445, for the CONSORT PRO Group.
29. Chan A, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013, 346:e7586. 10.1136/bmj.e7586, 3541470, 23303884.
30. Gardner F, Mayo-Wilson E, Montgomery P, Hopewell S, Macdonald G, Moher D, et al. Editorial perspective: the need for new guidelines to improve the reporting of trials in child and adolescent mental health. J Child Psychol Psychiatry 2013, 54(7):810-812. 10.1111/jcpp.12106, 23789914.
31. Grant S, Mayo-Wilson E, Hopewell S, Macdonald G, Moher D, Montgomery P. New guidelines are needed to improve the reporting of trials in addiction sciences. Addiction 2013, 108(9):1687-1688. 10.1111/add.12249, 23796394.
32. Montgomery P, Mayo-Wilson E, Hopewell S, Macdonald G, Moher D, Grant S. Developing a reporting guideline for social and psychological intervention trials. Am J Public Health 2013, Epub ahead of print.
33. Montgomery P, Grant S, Hopewell S, Macdonald G, Moher D, Mayo-Wilson E. Developing a reporting guideline for social and psychological intervention trials. Br J Soc Work 43(5):1024-1038.
34. Grant S, Mayo-Wilson E, Hopewell S, Macdonald G, Moher D, Montgomery P. Developing a reporting guideline for social and psychological intervention trials. J Exp Criminol 2013, 9(3):355-367.
35. Grant S, Montgomery P, Hopewell S, Macdonald G, Moher D, Mayo-Wilson E. Developing a reporting guideline for social and psychological intervention trials. Res Soc Work Pract Online Before Print.
36. Mayo-Wilson E, Grant S, Hopewell S, Macdonald G, Moher D, Montgomery P. Developing a reporting guideline for social and psychological intervention trials. Trials 2013, 14:242. 10.1186/1745-6215-14-242, 3734002, 23915044.
37. Mayo-Wilson E, Montgomery P, Hopewell S, Macdonald G, Moher D, Grant S. Developing a reporting guideline for social and psychological intervention trials. Br J Psychiatry 2013, In Press.
38. Altman DG. Endorsement of the CONSORT statement by high impact medical journals: a survey of instructions for authors. BMJ 2005, 330:1056-1057. 10.1136/bmj.330.7499.1056, 557224, 15879389.
39. Sinha IP, Smyth RL, Williamson PR. Using the delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med 2011, 8(1):e1000393. 10.1371/journal.pmed.1000393, 3026691, 21283604.
40. Jones J, Hunter D. Consensus methods for medical and health services research. BMJ 1995, 311(7001):376-380. 10.1136/bmj.311.7001.376, 2550437, 7640549.
41. Montgomery P, Grant SP. Development of a CONSORT extension for complex social interventions 2012, Auckland, New Zealand: Meeting at the 20th annual Cochrane Colloquium.
42. Murphy MK, Black NA, Lamping DL, McKee CM, Sanders CFB, Askham J. Consensus development methods, and their use in clinical guideline development. Health Technol Assess 1998, 2(3):1-88.
43. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, the CONSORT Group CONSORT for reporting randomised trials in journal and conference abstracts. Lancet 2008, 371:281-283. 10.1016/S0140-6736(07)61835-2, 18221781, the CONSORT Group.
44. Albrecht L, Archibald M, Arseneau D, Scott SD. Development of a checklist to assess the quality of reporting of knowledge translation interventions using the workgroup for intervention development and evaluation research (WIDER) recommendations. Implement Sci 2013, 8:52. 10.1186/1748-5908-8-52, 3661354, 23680355.
45. Marsh P, Fisher M. Developing the evidence base for social work and social care practice 2005, London: Social Care Institute for Excellence.
46. Littell JH, Corcoran JC, Pillai V. Systematic reviews and meta-analysis 2008, New York: Oxford University Press.
47. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs 2000, 32(4):1008-1015.
48. Michie S, Abraham C, Eccles MP, Francis JJ, Hardeman W, Johnston M. Strengthening evaluation and implementation by specifying components of behaviour change interventions: a study protocol. Implement Sci 2011, 6:10. 10.1186/1748-5908-6-10, 3041694, 21299860.
49. Bowling A. Research methods in health: investigating health and health services 2009, New York: McGraw-Hill.
50. Michie S, Fixsen D, Grimshaw JM, Eccles MP. Specifying and reporting complex behaviour change interventions: the need for a scientific method. Implement Sci 2009, 4:40. 10.1186/1748-5908-4-40, 2717906, 19607700.
51. West R. Editorial note: providing full manuals and intervention descriptions: addiction policy. Addiction 2008, 103:1411.