Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Methodology

Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension

Authors: Paul Montgomery, Sean Grant, Evan Mayo-Wilson, Geraldine Macdonald, Susan Michie, Sally Hopewell, David Moher, on behalf of the CONSORT-SPI Group

Published in: Trials | Issue 1/2018

Login to get access

Abstract

Background

Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018.

Methods

We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010.

Results

The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention.

Conclusions

Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.
Appendix
Available only for authorised users
Literature
1.
Petrosino A, Boruch RF, Rounding C, McDonald S, Chalmers I. The Campbell collaboration Social, Psychological, Educational and Criminological Trials Register (C2-SPECTR) to facilitate the preparation and maintenance of systematic reviews of social and educational interventions. Eval Res Educ. 2000;14(3–4):206–19.CrossRef
2.
Bristow D, Carter L, Martin S. Using evidence to improve policy and practice: the UK what works Centres. Contemp Soc Sci. 2015;10(2):126–37.CrossRef
3.
Social and Behavioral Sciences Team. 2015 Annual Report. Washington, DC: Executive Office of the President, National Science and Technology Council; 2015.
4.
5.
Petrosino A. Reflections on the genesis of the Campbell collaboration. Exp Criminol. 2013;8(2):9–12.
6.
Oliver S, Bagnall AM, Thomas J, et al. Randomised controlled trials for policy interventions: a review of reviews and meta-regression. Health Technol Assess. 2010;14(16):1–165.CrossRefPubMed
7.
Goodman S, Dickersin K. Metabias: a challenge for comparative effectiveness research. Ann Intern Med. 2011;155(1):61–2.CrossRefPubMed
8.
Moher D, Glasziou P, Chalmers I, et al. Increasing value and reducing waste in biomedical research: Who's listening? Lancet. 2015; Available online 27 September 2015:doi: 10.1016/S0140-6736(1015)00307-00304
9.
Hoffmann TC, Glasziou P, Boutron I, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.CrossRefPubMed
10.
Pinnock H, Epiphaniou E, Sheikh A, et al. Developing standards for reporting implementation studies of complex interventions (StaRI): a systematic review and e-Delphi. Implement Sci. 2015;10(1):42.CrossRefPubMedPubMedCentral
11.
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):355–67.CrossRef
12.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.CrossRefPubMedPubMedCentral
13.
Michie S, Fixsen D, Grimshaw J, Eccles M. Specifying and reporting complex behaviour change interventions: the need for a scientific method. Implement Sci. 2009;4:40.CrossRefPubMedPubMedCentral
14.
Mayo-Wilson E. Reporting implementation in randomized trials: proposed additions to the consolidated standards of reporting trials statement. Am J Public Health. 2007;97(4):630–3.CrossRefPubMedPubMedCentral
15.
16.
17.
Open Science Collaboration. Estimating the reproducibility of psychological science. Science. 2015;349(6251):aac4716.CrossRef
18.
19.
Open Science Collaboration. An open, large-scale, collaborative effort to estimate the reproducibility of psychological science. Perspect Psychol Sci. 2012;7(6):657–60.CrossRef
20.
Tajika A, Ogawa Y, Takeshima N, Hayasaka Y, Furukawa TA. Replication and contradiction of highly cited research papers in psychiatry: 10-year follow-up. Br J Psychiatry. 2015; Available online July 2015:doi: 10.1192/bjp.bp.1113.143701
21.
Michie S, Wood CE, Johnston M, Abraham C, Francis JJ, Hardeman W. Behaviour change techniques: the development and evaluation of a taxonomic method for reporting and describing behaviour change interventions (a suite of five studies involving consensus methods, randomised controlled trials and analysis of qualitative data). Health Technol Assess. 2015;19(99):1–187.CrossRefPubMedPubMedCentral
22.
Glasziou P, Altman DG, Bossuyt P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014;383(9913):267–76.CrossRefPubMed
23.
Driessen E, Hollon SD, Bockting CLH, Cuijpers P, Turner EH. Does publication bias inflate the apparent efficacy of psychological treatment for major depressive disorder? A systematic review and meta-analysis of us national institutes of health-funded trials. PLoS One. 2015;10(9):e0137864.CrossRefPubMedPubMedCentral
24.
Ioannidis JP, Munafo MR, Fusar-Poli P, Nosek BA, David SP. Publication and other reporting biases in cognitive sciences: detection, prevalence, and prevention. Trends Cogn Sci. 2014;18(5):235–41.CrossRefPubMedPubMedCentral
25.
Cybulski L, Mayo-Wilson E, Grant S. Improving transparency and reproducibility: registering clinical trials of psychological interventions prospectively and completely. J Consult Clin Psychol. 2016;84(9):753–67.
26.
27.
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637–9.CrossRefPubMed
28.
Moher D, Schulz KF, Altman D, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357(9263):1191–4.CrossRefPubMed
29.
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.CrossRef
30.
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;285:1992–5.CrossRefPubMed
31.
Turner L, Shamseer L, Altman DG, 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.PubMed
32.
Devereaux PJ, Manns BJ, Ghali WA, Quan H, Guyatt GH. The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the consolidated standards of reporting trials (CONSORT) checklist. Control Clin Trials. 2002;23:380–8.CrossRefPubMed
33.
Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.CrossRefPubMed
34.
Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG, for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012;308(24):2594–604.CrossRefPubMed
35.
36.
Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 statement. BMJ. 2015;350:h1738.CrossRefPubMed
37.
38.
Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8):814–22.CrossRefPubMed
39.
Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008;371:281–3.CrossRefPubMed
40.
Ioannidis JP, Evans SJ, Gotzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141:781–8.CrossRefPubMed
41.
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):W60–6.CrossRefPubMed
42.
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;144:364–7.CrossRefPubMed
43.
MacPherson H, Altman DG, Hammerschlag R, et al. Revised STandards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7(6):e1000261.CrossRefPubMedPubMedCentral
44.
Michie S, Richardson M, Johnston M, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46:81–95.CrossRefPubMed
45.
Michie S, Atkins L, West R. The Behaviour Change Wheel: A guide to designing interventions. UK: Silverback Publishing; 2014.
46.
Michie S, West R, Campbell R, Brown J, Gainforth H. ABC of Behaviour Change Theories: An essential resource for researchers, policy makers and practitioners. UK: Silverback Publishing; 2014.
47.
Davis RE, Campbell R, Hildon Z, Hobbs L, Michie S. Theories of behaviour and behaviour change across the social and behavioural sciences: a scoping review. Health Psychol Rev. 2015;9(3):323–44.CrossRefPubMed
48.
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148(4):295–309.CrossRefPubMed
49.
Fraser MW, Galinsky MJ, Richman JM, Day SH. Intervention research: developing social programs. New York: Oxford University Press; 2009.
50.
51.
Grant S. Development of a CONSORT Extension for Social and Psychological Interventions. Oxford: Social Policy & Intervention, University of Oxford; 2014.
52.
Institute of Medicine. Psychosocial interventions for mental and substance use disorders: A framework for establishing evidence-based standards. Washington, DC: the National Academies Press; 2015.
53.
Bonell C, Jamal F, Melendez-Torres GJ, Cummins S. ‘Dark logic’: theorising the harmful consequences of public health interventions. J Epidemiol Community Health. 2015;69(1):95–8.CrossRefPubMed
54.
55.
Øvretveit J. Evaluating improvement and implementation for health. Berkshire: Open University Press; 2014.
56.
57.
Bonell C. The utility of randomized controlled trials of social interventions: an examination of two trials of HIV prevention. Critical Public Health. 2002;12(4):321–34.CrossRef
58.
Shadish WR, Cook TD, Campbell DT. Experimental and quasi-experimental designs for generalized causal inference. Belmont: Wadsworth; 2002.
59.
Sniehotta FF, Araújo-Soares V, Brown J, Kelly MP, Michie S, West R. Complex systems and individual-level approaches to population health: a false dichotomy? Lancet Public Health. 2017;2(9):e396–7.CrossRefPubMed
60.
Weiss MJ, Bloom HS, Brock T. A conceptual framework for studying the sources of variation in program effects. New York: MDRC; 2013.
61.
62.
Grant S, Montgomery P, Hopewell S, Macdonald G, Moher D, Mayo- Wilson E. Letter to the editor: new guidelines are needed to improve the reporting of trials in addiction sciences. Addiction. 2013;108:1687–8.CrossRefPubMed
63.
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. 2013;23(6):595–602.CrossRefPubMedPubMedCentral
64.
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.CrossRefPubMedPubMedCentral
65.
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;203:250–4.CrossRefPubMed
66.
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. 2013;43(5):1024–38.CrossRef
67.
Montgomery P, Mayo-Wilson E, Hopewell S, G M, Moher D, Grant S. Developing a reporting guideline for social and psychological intervention trials. Am J Public Health. 2013;103(10):1741–6.CrossRefPubMedPubMedCentral
68.
Gardner F, Mayo-Wilson E, Montgomery P, 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):810–2.CrossRefPubMed
69.
70.
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.CrossRefPubMedPubMedCentral
71.
Moher D, Weeks L, Ocampo M, et al. Describing reporting guidelines for health research: a systematic review. J Clin Epidemiol. 2011;64(7):718–42.CrossRefPubMed
72.
Moher D, Hopewell S, Schultz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.CrossRefPubMedPubMedCentral
73.
Murphy MK, Black NA, Lamping DL, et al. Consensus development methods, and their use in clinical guideline development. Health Technol Assess. 1998;2(3):i-iv, 1–88.
74.
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.CrossRefPubMedPubMedCentral
75.
Shamseer L, Moher D, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015;349:g7647.CrossRef
76.
Hopewell S, Ravaud P, Baron G, Boutron I. Effect of editors’ implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis. BMJ. 2012;344:e4178.CrossRefPubMedPubMedCentral
77.
78.
Harrison BA, Mayo-Wilson E. Trial registration: understanding and preventing reporting bias in social work research. Res Soc Work Pract. 2014;24(3):372–6.CrossRef
79.
80.
81.
82.
83.
Michie S, Thomas J, Johnston M, et al. The human behaviour-change project: harnessing the power of artificial intelligence and machine learning for evidence synthesis and interpretation. Implement Sci. 2017;12:121.CrossRefPubMedPubMedCentral
84.
85.
Agarwal S, LeFevre AE, Lee J, et al. Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) checklist. BMJ. 2016;352:i1174.CrossRefPubMed
86.
Stevens A, Shamseer L, Weinstein E, et al. Relation of completeness of reporting of health research to journals’ endorsement of reporting guidelines: systematic review. BMJ. 2014;348:g3804.CrossRefPubMedPubMedCentral
87.
Des Jarlais DC, Lyles C, Crepaz N, the TREND Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004;94(3):361–6.CrossRefPubMedPubMedCentral
Metadata
Title
Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension
Authors
Paul Montgomery
Sean Grant
Evan Mayo-Wilson
Geraldine Macdonald
Susan Michie
Sally Hopewell
David Moher
on behalf of the CONSORT-SPI Group
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2733-1

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

The therapeutic potential of attentional bias modification training for insomnia: study protocol for a randomised controlled trial

Study protocol

Silver diamine fluoride versus therapeutic sealants for the arrest and prevention of dental caries in low-income minority children: study protocol for a cluster randomized controlled trial

Study protocol

Frailty Intervention Trial iN End-Stage patientS on haemodialysis (FITNESS): study protocol for a randomised controlled trial

Study protocol

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial

Study protocol

High-intensity versus low-intensity noninvasive positive pressure ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease (HAPPEN): study protocol for a multicenter randomized controlled trial

Study protocol

Preloop trial: study protocol for a randomized controlled trial