Quality of reporting of complex healthcare interventions and applicability of the CReDECI list - a survey of publications indexed in PubMed

BMC Medical Research Methodology

Gabriele Meyer¹  Gabriele Bartoszek²  Ralph Möhler² 

[1] Institute of Health and Nursing Science, Martin-Luther-University Halle-Wittenberg, Magdeburger Strasse 8, 06112, Halle/Saale, Germany;School of Nursing Science, Faculty of Health, Witten/Herdecke University, Stockumer Strasse 12, 58453, Witten, Germany

关键词: Review;    Research design;    Reporting guideline;    Evidence-based nursing;    Complex interventions;   

Others  :  866643
DOI  :  10.1186/1471-2288-13-125

 received in 2013-03-13, accepted in 2013-10-18,  发布年份 2013

【 摘 要 】

Background

The development and evaluation of complex interventions in healthcare has obtained increased awareness. The Medical Research Council’s (MRC) framework for the development and evaluation of complex interventions and its update offers guidance for researchers covering the phases development, feasibility/piloting, and evaluation. Comprehensive reporting of complex interventions enhances transparency and is essential for researchers and policy-makers. Recently, a set of 16 criteria for reporting complex interventions in healthcare (CReDECI) was published. The aim of this study is to evaluate the reporting quality in publications of complex interventions adhering to either the first or the updated MRC framework, and to evaluate the applicability of CReDECI.

Methods

A systematic PubMed search was conducted. Two reviewers independently checked titles and abstracts for inclusion. Trials on complex interventions adhering to the MRC framework and including an evaluation study in English and German were included. For all included trials and for all publications which reported on phases prior to the evaluation study, related publications were identified via forward citation tracking. The quality of reporting was assessed independently by two reviewers using CReDECI. Inter-rater agreement and time needed to complete the assessment were determined.

Results

Twenty-six publications on eight trials were included. The number of publications per trial ranged from 1 to 6 (mean 3.25). The trials demonstrate a good reporting quality for the criteria referring to the development and feasibility/piloting. For the criteria addressing the introduction of the intervention and the evaluation, quality of reporting varied widely. Two trials fulfilled 7 and 8 items respectively, five trials fulfilled one to five items and one trial offered no information on any item. The mean number of items with differing ratings per trial was two. The time needed to rate a trial ranged from 30 to 90 minutes, depending on the number of publications.

Conclusions

Adherence to the MRC framework seems to have a positive impact on the reporting quality on the development and piloting of complex interventions. Reporting on the evaluation could be improved. CReDECI is a practical instrument to check the reporting quality of complex interventions and could be used alongside design-specific reporting guidelines.

【 授权许可】

   
2013 Möhler et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P: Framework for design and evaluation of complex interventions to improve health. BMJ 2000, 321:694-696.
• [2]Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Developing and evaluating complex interventions: new guidance. 2008. http://www.mrc.ac.uk/complexinterventionsguidance webcite
• [3]Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, Medical Research Council Guidance: Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008, 337:a1655.
• [4]Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Developing and evaluating complex interventions: the new medical research council guidance. Int J Nurs Stud 2013, 50:587-592.
• [5]Hawe P, Shiell A, Riley T, Gold L: Methods for exploring implementation variation and local context within a cluster randomised community intervention trial. J Epidemiol Community Health 2004, 58:788-793.
• [6]Oakley A, Strange V, Bonell C, Allen E, Stephenson J, RIPPLE Study Team: Process evaluation in randomised controlled trials of complex interventions. BMJ 2006, 332:413-416.
• [7]Spillane V, Byrne MC, Byrne M, Leathem CS, O’Malley M, Cupples ME: Monitoring treatment fidelity in a randomized controlled trial of a complex intervention. J Adv Nurs 2007, 60:343-352.
• [8]Armstrong R, Waters E, Moore L, Riggs E, Cuervo LG, Lumbiganon P, Hawe P: Improving the reporting of public health intervention research: advancing TREND and CONSORT. J Public Health 2008, 30:103-109.
• [9]Egan M, Bambra C, Petticrew M, Whitehead M: Reviewing evidence on complex social interventions: appraising implementation in systematic reviews of the health effects of organisational-level workplace interventions. J Epidemiol Community Health 2009, 63:4-11.
• [10]Shepperd S, Lewin S, Straus S, Clarke M, Eccles MP, Fitzpatrick R, Wong G, Sheikh A: Can we systematically review studies that evaluate complex interventions? PLoS Med 2009, 6:e1000086.
• [11]Mayo-Wilson E: Reporting implementation in randomized trials: proposed additions to the consolidated standards of reporting trials statement. Am J Public Health 2007, 97:630-633.
• [12]Möhler R, Richter T, Köpke S, Meyer G: Interventions for preventing and reducing the use of physical restraints in long-term geriatric care - a Cochrane review. J Clin Nurs 2012, 21:3070-3081.
• [13]Redfern J, McKevitt C, Wolfe CD: Development of complex interventions in stroke care: a systematic review. Stroke 2006, 37:2410-2419.
• [14]Möhler R, Bartoszek G, Köpke S, Meyer G: Proposed criteria for reporting the development and evaluation of complex interventions in healthcare (CReDECI): guideline development. Int J Nurs Stud 2012, 49:40-46.
• [15]Greenhalgh T, Peacock R: Effectiveness and efficiency of search methods in systematic reviews of complex evidence: audit of primary sources. BMJ 2005, 331:1064-1065.
• [16]Tilling K, Coshall C, McKevitt C, Daneski K, Wolfe C: A family support organiser for stroke patients and their carers: a randomised controlled trial. Cerebrovasc Dis 2005, 20:85-91.
• [17]Avery AJ, Rodgers S, Cantrill JA, Armstrong S, Cresswell K, Eden M, Elliott RA, Howard R, Kendrick D, Morris CJ, Prescott RJ, Swanwick G, Franklin M, Putman K, Boyd M, Sheikh A: A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis. Lancet 2012, 379:1310-1319.
• [18]Strong V, Waters R, Hibberd C, Murray G, Wall L, Walker J, McHugh G, Walker A, Sharpe M: Management of depression for people with cancer (SMaRT oncology 1): a randomised trial. Lancet 2008, 372:40-48.
• [19]Wolfe CD, Redfern J, Rudd AG, Grieve AP, Heuschmann PU, McKevitt C: Cluster randomized controlled trial of a patient and general practitioner intervention to improve the management of multiple risk factors after stroke: stop stroke. Stroke 2010, 41:2470-2476.
• [20]Murphy AW, Cupples ME, Smith SM, Byrne M, Byrne MC, Newell J, SPHERE study team: Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial. BMJ 2009, 339:b4220.
• [21]Smith SM, Paul G, Kelly A, Whitford DL, O’Shea E, O’Dowd T: Peer support for patients with type 2 diabetes: cluster randomised controlled trial. BMJ 2011, 342:d715.
• [22]Klinkhammer-Schalke M, Koller M, Steinger B, Ehret C, Ernst B, Wyatt JC, Hofstädter F, Lorenz W, Regensburg QoL Study Group: Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer. Br J Cancer 2012, 106:826-838.
• [23]Faes MC, Reelick MF, Melis RJ, Borm GF, Esselink RA, Rikkert MG: Multifactorial fall prevention for pairs of frail community-dwelling older fallers and their informal caregivers: a dead end for complex interventions in the frailest fallers. J Am Med Dir Assoc 2011, 12:451-458.
• [24]Avery AJ, Rodgers S, Cantrill JA, Armstrong S, Elliott R, Howard R, Kendrick D, Morris CJ, Murray SA, Prescott RJ, Cresswell K, Sheikh A: Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices. Trials 2009, 10:28. BioMed Central Full Text
• [25]Avery AJ, Rodgers S, Cantrill JA, Armstrong S, Boyd M, Cresswell K, Eden M, Elliott R, Franklin M, Howard R, Hippisley-Cox J, Kendrick D, Morris CJ, Murray SA, Prescott RJ, Putman K, Swanwick G, Tuersley L, Turner T, Vinogradova Y, Sheikh A: PINCER trial. Report for the department of health patient safety research portfolio 2010. Adv Physiol Educhttp://www.birmingham.ac.uk/Documents/college-mds/haps/projects/cfhep/psrp/finalreports/PS024PINCERFinalReportOctober2010.pdf webcite
• [26]Sharpe M, Strong V, Allen K, Rush R, Maguire P, House A, Ramirez A, Cull A: Management of major depression in outpatients attending a cancer centre: a preliminary evaluation of a multicomponent cancer nurse-delivered intervention. Br J Cancer 2004, 90:310-313.
• [27]Bower P, Gilbody S, Richards D, Fletcher J, Sutton A: Collaborative care for depression in primary care. Making sense of a complex intervention: systematic review and meta-regression. Br J Psychiatry 2006, 189:484-493.
• [28]Redfern J, Rudd AD, Wolfe CD, McKevitt C: Stop Stroke: development of an innovative intervention to improve risk factor management after stroke. Patient Educ Couns 2008, 72:201-209.
• [29]Byrne M, Cupples ME, Smith SM, Leathem C, Corrigan M, Byrne MC, Murphy AW: Development of a complex intervention for secondary prevention of coronary heart disease in primary care using the UK medical research council framework. Am J Manag Care 2006, 12:261-266.
• [30]Corrrigan M, Cupples ME, Smith SM, Byrne M, Leathem CS, Clerkin P, Murphy AW: The contribution of qualitative research in designing a complex intervention for secondary prevention of coronary heart disease in two different healthcare systems. BMC Health Serv Res 2006, 6:90. BioMed Central Full Text
• [31]Murphy AW, Cupples ME, Smith SM, Byrne M, Leathem C, Byrne MC, The SPHERE Study: Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses [ISRCTN24081411]. Curr Control Trials Cardiovasc Med 2005, 6:11. BioMed Central Full Text
• [32]Gillespie P, O’Shea E, Murphy AW, Byrne MC, Byrne M, Smith SM, Cupples ME: The cost-effectiveness of the SPHERE intervention for the secondary prevention of coronary heart disease. Int J Technol Assess Health Care 2010, 26:263-271.
• [33]Paul G, Smith SM, Whitford D, O’Kelly F, O’Dowd T: Development of a complex intervention to test the effectiveness of peer support in type 2 diabetes. BMC Health Serv Res 2007, 7:136. BioMed Central Full Text
• [34]Paul GM, Smith SM, Whitford DL, O’Shea E, O’Kelly F, O’Dowd T: Peer support in type 2 diabetes: a randomised controlled trial in primary care with parallel economic and qualitative analyses: pilot study and protocol. BMC Fam Pract 2007, 8:45. BioMed Central Full Text
• [35]Gillespie P, O’Shea E, Paul G, O’Dowd T, Smith SM: Cost effectiveness of peer support for type 2 diabetes. Int J Technol Assess Health Care 2012, 28:3-11.
• [36]Koller M, Klinkhammer-Schalke M, Ehret C, Steinger B, Ernst B, Hofstädter F, Lorenz W, Mitglieder des Qualitätszitkels; Advisory Board: [Diagnosis and therapy of illness-related quality of life in breast cancer patients. Protocol of a randomized clinical trial at the Regensburg tumour centre]. Z Arztl Fortbild Qualitatssich 2006, 100:175-182.
• [37]Klinkhammer-Schalke M, Koller M, Wyatt JC, Steinger B, Ehret C, Ernst B, Hofstädter F, Lorenz W: Quality of life diagnosis and therapy as complex intervention for improvement of health in breast cancer patients: delineating the conceptual, methodological, and logistic requirements (modeling). Langenbecks Arch Surg 2008, 393:1-12.
• [38]Klinkhammer-Schalke M, Koller M, Ehret C, Steinger B, Ernst B, Wyatt JC, Hofstädter F, Lorenz W, Regensburg QoL Study Group: Implementing a system of quality-of-life diagnosis and therapy for breast cancer patients: results of an exploratory trial as a prerequisite for a subsequent RCT. Br J Cancer 2008, 99:415-422.
• [39]Faes MC, Reelick MF, Esselink RA, Rikkert MG: Developing and evaluating complex healthcare interventions in geriatrics: the use of the medical research council framework exemplified on a complex fall prevention intervention. J Am Geriatr Soc 2010, 58:2212-2221.
• [40]Reelick MF, Faes MC, Esselink RA, Kessels RP, Olde Rikkert MG: How to perform a preplanned process evaluation for complex interventions in geriatric medicine: exemplified with the process evaluation of a complex falls-prevention program for community-dwelling frail older fallers. J Am Med Dir Assoc 2011, 12:331-336.
• [41]Thompson C, Stapley S: Do educational interventions improve nurses’ clinical decision making and judgement? a systematic review. Int J Nurs Stud 2011, 48:881-893.
• [42]Schroter S, Glasziou P, Heneghan C: Quality of descriptions of treatments: a review of published randomised controlled trials. BMJ Open 2012, 2:e001978.
• [43]Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B: Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials 2013, 14:15. BioMed Central Full Text
• [44]Wells M, Williams B, Treweek S, Coyle J, Taylor J: Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions. Trials 2012, 13:95. BioMed Central Full Text
• [45]Moher D, Weeks L, Ocampo M, Seely D, Sampson M, Altman DG, Schulz KF, Miller D, Simera I, Grimshaw J, Hoey J: Describing reporting guidelines for health research: a systematic review. J Clin Epidemiol 2011, 64:718-742.
• [46]Department of social policy and Intervention: A CONSORT extension for social and psychological interventions. http://www.spi.ox.ac.uk/research/centre-for-evidence-based-intervention/consort-study.html webcite