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

Implementation Science

Evan Mayo-Wilson³  Susan Michie³  David Moher⁵  Geraldine Macdonald²  Sally Hopewell⁴  Sean Grant¹  Paul Montgomery¹ 

[1] Centre for Evidence-Based Intervention, University of Oxford, Barnett House, 32 Wellington Square, Oxford OX1 2ER, UK;Institute of Child Care Research, Queen’s University Belfast, 6 College Park, Belfast BT7 1LP, UK;Centre for Outcomes Research and Effectiveness, Research Department of Clinical, Educational & Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK;Centre for Statistics in Medicine, University of Oxford, Botnar Research Centre, Windmill Road, Oxford, OX3 7LD, UK;Clinical Epidemiology Program, Ottawa Hospital Research Institute, Centre for Practice-Changing Research (CPCR), The Ottawa Hospital - General Campus, 501 Smyth Rd, Room L1288, Ottawa, ON K1H 8L6, Canada

关键词: Complex interventions;    Reporting guidelines;    RCT;    Randomised controlled trial;    CONSORT-SPI;   

Others  :  813377
DOI  :  10.1186/1748-5908-8-99

 received in 2013-06-27, accepted in 2013-08-29,  发布年份 2013

【 摘 要 】

Background

Determining the effectiveness of social and psychological interventions is important for improving individual and population health. Such interventions are complex and, where possible, are best evaluated by randomised controlled trials (RCTs). The use of research findings in policy and practice decision making is hindered by poor reporting of RCTs. Poor reporting limits the ability to replicate interventions, synthesise evidence in systematic reviews, and utilise findings for evidence-based policy and practice. The lack of guidance for reporting the specific methodological features of complex intervention RCTs contributes to poor reporting. We aim to develop an extension of the Consolidated Standards of Reporting Trials Statement for Social and Psychological Interventions (CONSORT-SPI).

Methods/design

This research project will be conducted in five phases. The first phase was the project launch, which consisted of the establishment of a Project Executive and International Advisory Group, and recruitment of journal editors and the CONSORT Group. The second phase involves a Delphi process that will generate a list of possible items to include in the CONSORT Extension. Next, there will be a formal consensus meeting to select the reporting items to add to, or modify for, the CONSORT-SPI Extension. Fourth, guideline documents will be written, including an explanation and elaboration (E&E) document that will provide detailed advice for each item and examples of good reporting. The final phase will comprise guideline dissemination, with simultaneous publication and endorsement of the guideline in multiple journals, endorsement by funding agencies, presentations at conferences and other meetings, and a dedicated website that will facilitate feedback about the guideline.

Conclusion

As demonstrated by previous CONSORT guidelines, the development of an evidence-based reporting guideline for social and psychological intervention RCTs should improve the accuracy, comprehensiveness, and transparency of study reports. This, in turn, promises to improve the critical appraisal of research and its use in policy and practice decision making. We invite readers to participate in the project by visiting our website (http://tinyurl.com/CONSORT-study webcite).

【 授权许可】

   
2013 Montgomery et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Medical Research Council: A framework for development and evaluation of RCTs for complex interventions to improve health. London: MRC; 2008.
• [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.
• [5]Campbell MK, Elbourne DR, Altman DG: CONSORT statement: extension to cluster randomised trials. BMJ 2004, 328:702-708.
• [6]Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, for the CONSORT and Pragmatic Trials in Healthcare (Practihc) group, et al.: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008, 337:a2390.
• [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.
• [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.
• [9]Moher D, Schulz KF, Simera I, Altman DG: Guidance for developers of health research reporting guidelines. PLoS Med 2010, 7(2):e1000217.
• [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.
• [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.
• [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.
• [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.
• [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.
• [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.
• [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.
• [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. BioMed Central Full Text
• [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.
• [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.
• [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.
• [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.
• [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.
• [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.
• [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 PractOnline 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. BioMed Central Full Text
• [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.
• [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.
• [40]Jones J, Hunter D: Consensus methods for medical and health services research. BMJ 1995, 311(7001):376-380.
• [41]Montgomery P, Grant SP: Development of a CONSORT extension for complex social interventions. Auckland, New Zealand: Meeting at the 20th annual Cochrane Colloquium; 2012.
• [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.
• [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. BioMed Central Full Text
• [45]Marsh P, Fisher M: Developing the evidence base for social work and social care practice. London: Social Care Institute for Excellence; 2005.
• [46]Littell JH, Corcoran JC, Pillai V: Systematic reviews and meta-analysis. New York: Oxford University Press; 2008.
• [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. BioMed Central Full Text
• [49]Bowling A: Research methods in health: investigating health and health services. New York: McGraw-Hill; 2009.
• [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. BioMed Central Full Text
• [51]West R: Editorial note: providing full manuals and intervention descriptions: addiction policy. Addiction 2008, 103:1411.