Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

Hemming, Karla; Taljaard, Monica; McKenzie, Joanne E.; Hooper, Richard; Copas, Andrew; Thompson, JA; Dixon‐Woods, Mary; Aldcroft, Adrian; Doussau, A.; Grayling, Michael J.; Kristunas, Caroline; Goldstein, Cory E.; Campbell, Marion K; Girling, Alan; Eldridge, Sandra; Campbell, Mike; Lilford, Richard; Weijer, Charles; Forbes, Andrew Benjamin; Grimshaw, Jeremy

doi:10.1136/bmj.k1614

Cited by 268 publications

(308 citation statements)

References 83 publications

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“…We employ an incomplete stepped wedge, cluster randomized controlled trial (SW-CRT) design and mixed methods. For reporting, we follow the Consolidated Standards of Reporting Trials (CONSORT) for stepped wedge cluster-randomized trial designs [27] and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (Additional file 1) [28]. We conduct a Hybrid Type II Implementation-Effectiveness trial [29] in both the Education and Health sectors in Bungoma South Sub-County in Kenya.…”

Section: Trial Designmentioning

confidence: 99%

Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): protocol for a stepped wedge cluster randomized trial

et al. 2020

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Background: The mental health treatment gap-the difference between those with mental health need and those who receive treatment-is high in low-and middle-income countries. Task-shifting has been used to address the shortage of mental health professionals, with a growing body of research demonstrating the effectiveness of mental health interventions delivered through task-shifting. However, very little research has focused on how to embed, support, and sustain task-shifting in government-funded systems with potential for scale up. The goal of the Building and Sustaining Interventions for Children (BASIC) study is to examine implementation policies and practices that predict adoption, fidelity, and sustainment of a mental health intervention in the education sector via teacher delivery and the health sector via community health volunteer delivery. Methods: BASIC is a Hybrid Type II Implementation-Effectiveness trial. The study design is a stepped wedge, cluster randomized trial involving 7 sequences of 40 schools and 40 communities surrounding the schools. Enrollment consists of 120 teachers, 120 community health volunteers, up to 80 site leaders, and up to 1280 youth and one of their primary guardians. The evidence-based mental health intervention is a locally adapted version of Traumafocused Cognitive Behavioral Therapy, called Pamoja Tunaweza. Lay counselors are trained and supervised in Pamoja Tunaweza by local trainers who are experienced in delivering the intervention and who participated in a Train-the-Trainer model of skills transfer. After the first sequence completes implementation, in-depth interviews are conducted with initial implementing sites' counselors and leaders. Findings are used to inform delivery of implementation facilitation for subsequent sequences' sites. We use a mixed methods approach including qualitative comparative analysis to identify necessary and sufficient implementation policies and practices that predict 3 implementation outcomes of interest: adoption, fidelity, and sustainment. We also examine child mental health outcomes and cost of the intervention in both the education and health sectors. Discussion: The BASIC study will provide knowledge about how implementation of task-shifted mental health care can be supported in government systems that already serve children and adolescents. Knowledge about implementation policies and practices from BASIC can advance the science of implementation in low-resource contexts.

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Section: Trial Designmentioning

confidence: 99%

Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): protocol for a stepped wedge cluster randomized trial

et al. 2020

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“…The pancreatic cancer team included at least a medical oncologist, a gastroenterologist, and a surgeon, regularly together with a specialized nurse. This trial was designed in adherence to the CONSORT statement for cluster randomized trials [17] and extension for stepped-wedge trials [18], and SPIRIT guidelines for clinical trials [19]. For an overview of PACAP-1, see the SPIRIT figure ( Fig.…”

Section: Pacap-1 Trial Design {8} {13}mentioning

confidence: 99%

Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial

Mackay¹,

Smits²,

Latenstein³

et al. 2020

Trials

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Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial Abstract Background: Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life.(Continued on next page) Methods/design: PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3-and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide. Discussion: The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life. Trial registration: ClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equa tor-network.org/reporting-guidelines/spirit-2013-statementdefining-standard-protocol-items-for-clinical-trials/). Title {1}Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial Trial registration {2a and 2b}. Trial open for accr...

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“…It consists of 10 items and 5 sub-elements, which are evaluated as: Yes, No, Not clear (Boutron et al, 2017). CONSORT-PRO, whose objective was to determine the results reported by the patients (PRO), which are usually inadequately reported, thus limiting the value of the data (Calvert et al, 2013); CONSORT-SPI, published in 2013 (Montgomery et al, 2013), and updated in 2018, for reporting randomized clinical trials (RCTs) of social and psychological interventions, extends 9 of the 25 items from CONSORT 2010 (CONSORT 2010), added a new item related to stakeholder involvement, and modified aspects of the flow diagram (Montgomery et al, 2018); IMPRINT, which seeks to improve CT information of infertility treatments (Harbin Consensus Conference Workshop Group et al, 2014); TIDIER checklist, for the report of interventions in evaluative studies, including CT (Hoffmann et al, 2014); adaptation to CT in orthodontics (Pandis et al, 2015); the "n-de-1", to evaluate the effectiveness of an intervention in a single patient (Vohra et al, 2016); PAFS, for the report of randomized pilot and feasibility trials, added 11 items grouped in 7 domains ; KCONSORT (2009) renamed STORK standards (2016), to generate a standard for reporting results in intervention studies where they were going to be used Kampo Products (Motoo et al, 2017); protocol for a scoping review to support development of a CONSORT extension for RCTs using cohorts and routinely collected health data, published in 2018 (Kwakkenbos et al, 2018); SW-CRT, published in 2018, for reporting of stepped wedge cluster RCT consist in 40 items grouped in 26 domains (Hemming et al, 2018); ADs, published in 2018, extension for adaptive design RCT, adjusting 24 items of 16 domains of the CONSORT 2010 (Dimairo et al, 2018); MAPGRT for reporting of Multi-Arm Parallel-Group RCT, expanding on 10 items of the CONSORT 2010 (Juszczak et al, 2019); PRT for reporting within person RCT, it extends 16 items of the CONSORT 2010 checklist and introduces a modified flowchart and baseline table (Pandis et al, 2019). None of them considers score allocation.…”

Section: Consort Statementsmentioning

confidence: 99%

Statements, Recommendations, Proposals, Guidelines, Checklists and Scales Available for Reporting Results in Biomedical Research and Quality of Conduct. A Systematic Review

et al. 2020

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OTZEN, T.; MANTEROLA, T.; MORA, M.; QUIROZ, G.; SALAZAR, P. & GARCÍA, N. Statements, recommendations, proposals, guidelines, checklists and scales available for reporting results in biomedical research and quality of conduct. A systematic review. Int. J. morphol., 38(3):774-786, 2020. SUMMARY:Research reporting statements, recommendations, proposals, guidelines, checklists and scales can improve quality of reporting results in biomedical research. The aim of this study was to describe statements, recommendations, proposals, guidelines, checklists and scales available for reporting results and quality of conduct in biomedical research. Systematic review. All types statements, recommendations, proposals, guidelines, checklists and scales generated to improve the quality of the biomedical research results report were included. Data sources: EMBASE, HINARI, MEDLINE and Redalyc; in the libraries BIREME-BVS, SciELO and The Cochrane Library; in the meta-searchers Clinical Evidence and TRIP Database; and on the Websites of EQUATOR Network, BMC Medical Education and EUROPE PMC were used. The recovered documents were grouped as study design related to systematic reviews (SR) meta-analysis and meta-reviews, CT and RCTs and quasi-experimental studies, observational studies, diagnostic accuracy studies, clinical practice guidelines; biological material, animal and preclinical studies; qualitative studies; economic evaluation and decision analysis studies; and methodological quality (MQ) scales). The 93 documents were obtained.

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Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

Cited by 268 publications

References 83 publications

Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): protocol for a stepped wedge cluster randomized trial

Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): protocol for a stepped wedge cluster randomized trial

Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial

Statements, Recommendations, Proposals, Guidelines, Checklists and Scales Available for Reporting Results in Biomedical Research and Quality of Conduct. A Systematic Review

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