1. ABOUT THE DATASET -------------------- Title: Community-based complex interventions to sustain independence in older people systematic review and network meta-analysis: risk-of-bias dataset Creators: Thomas Frederick Crocker[1], Natalie Lam[1], Magda Jordão[1], Caroline Brundle[1], Matthew Prescott[1], Anne Forster[1], Joie Ensor[2], John Gladman[3], Andrew Clegg[1] Organisations: 1: Academic Unit for Ageing and Stroke Research (University of Leeds), Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK 2: Centre for Prognosis Research, Keele School of Medicine, Keele University, Keele, Staffordshire, UK 3: Centre for Rehabilitation & Ageing Research, Academic Unit of Injury, Inflammation and Recovery Sciences, University of Nottingham and Health Care of Older People, Nottingham University Hospitals NHS Trust, Nottingham, UK Rights-holders: Unless otherwise stated, Copyright 2023 University of Leeds Publication Year: 2023 Description: This dataset contains risk-of-bias assessment process data and judgments for the results of trials of community-based complex interventions to sustain independence in older people. These datasets were produced in the course of conducting a systematic review and network meta-analyses registered with PROSPERO: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019162195 Cite as: Crocker TF, Lam N, Jordão M, Brundle C, Prescott M, Forster A, et al. (2023) Community-based complex interventions to sustain independence in older people systematic review and network meta-analysis: risk-of-bias dataset. University of Leeds. [Dataset] https://doi.org/10.5518/1386 Related publications: Clegg A, Crocker T, Forster A, Gladman J, Riley R, Ensor J, et al. Community-based complex interventions to sustain independence in older people, stratified by frailty: a systematic review and network meta-analysis. PROSPERO 2019 CRD42019162195. 2019. URL: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019162195 (Accessed 23 November 2022). Crocker TF, Clegg A, Riley RD, Lam N, Bajpai R, Jordão M, et al. Community-based complex interventions to sustain independence in older people, stratified by frailty: a protocol for a systematic review and network meta-analysis. BMJ Open 2021;11:e045637. https://doi.org/10.1136/bmjopen-2020-045637 Crocker TF, Lam N, Ensor J, Jordão M, Bajpai R, Bond M, et al. Community-based complex interventions to sustain independence in older people, stratified by frailty: a systematic review and network meta-analysis. Health Technol Assess in press. Crocker TF, Lam N, Jordão M, Brundle C, Prescott M, Forster A, et al. Risk-of-bias assessment using RoB2 was useful but challenging and resource-intensive: observations from a systematic review. J Clin Epidemiol 2023; 10.1016/j.jclinepi.2023.06.015. https://doi.org/10.1016/j.jclinepi.2023.06.015 Crocker TF, Lam N, Ensor J, Jordão M, Bajpai R, Bond M, et al. (2023) Community-based complex interventions to sustain independence in older people systematic review and network meta-analysis: effect estimates and findings dataset. University of Leeds. [Dataset] https://doi.org/10.5518/1377 Contact: Tom Crocker, medtcro@leeds.ac.uk 2. TERMS OF USE --------------- Copyright 2023 University of Leeds. Unless otherwise stated, this dataset is licensed under a Creative Commons Attribution 4.0 International Licence: https://creativecommons.org/licenses/by/4.0/. 3. PROJECT AND FUNDING INFORMATION ---------------------------------- Title: Community-based complex interventions to sustain independence in older people, stratified by frailty: a systematic review and network meta-analysis Dates: 2020-2022 Funding organisation: National Institute for Health Research Health Technology Assessment programme Grant no.: NIHR128862 URLs: https://www.fundingawards.nihr.ac.uk/award/NIHR128862 https://medicinehealth.leeds.ac.uk/directory_record/1314/community-based-complex-interventions-to-sustain-independence-in-older-people Ethics approval was not sought as this systematic review was secondary research using aggregated, anonymised data that is available in the public domain. Process data relates to the authors. 4. CONTENTS ----------- included_studies.pdf contains a PRISMA 2020 diagram and the references for each of the 129 studies included in the systematic review. individual_timings.csv contains data about how long it took each individual reviewer to conduct independent risk-of-bias assessments for each study. This includes studies with timing data for two complete individual assessments only. Times are presented per reviewer. - study_authors Author name of the study's primary reference - study_year Year of the study's primary reference - reports Total number of reports associated with the study - results Total number of results of interest associated with the study - reviewer_[a...e] Binary variables relating to each of the reviewers. - experience The number of studies a reviewer had assessed risk of bias for prior to conducting that assessment. [0..*] - started The date risk-of-bias assessment started. - total_time_mins The total time in minutes taken by the reviewer to assess risk of bias for the study. - ended The date risk-of-bias assessment ended. - days_worked The total number of days on which the risk of bias assessment was conducted. consensus_timings.csv contains data about how long the consensus meetings for risk-of-bias assessments lasted for each study. This includes studies with timing data for consensus meetings (following two independent individual assessments). Times are presented for the meeting in which two reviewers were present. Fields (where included) are as above except: - group_experience The number of previous days on which risk of bias consensus meetings had been conducted. [0..*] - total_time_mins The total time in minutes that the consensus meeting lasted. overall_resource__timings.csv contains data about both individual (independent) assessments (combined) and the consensus meetings, and overall resource (total time taken for both reviewers together). This includes studies with timing data for two complete individual assessments and a consensus meeting. Times are presented for total resource use counting both reviewers. Fields (where included) are as above except: - those including "_individual" relate to individual assessments and those including "_consensus" relate to consensus assessments. - least_experience_individual is the lesser of the experience (as above) of the two reviewers. - most_experience_individual is the greater of the experience (as above) of the two reviewers. - total_time_overall counts the time in minutes for both reviewers (i.e. total_time_individual_mins + 2*total_time_consensus_mins) ROB2_judgments.xlsx contains judgments per domain and overall of risk of bias rated with the Cochrane RoB 2 tool for each result of interest. - Outcome Outcome domain that the result of interest relates to. - Timeframe Timeframe that the result of interest relates to. - Study The study that the result of interest is from. - Experimental_intervention The group the experimental intervention was identified as being from. - Control_intervention The group the control intervention was identified as being from. - Specific_measure The specific details of the outcome that was assessed. - D1_individual Domain 1: risk of bias arising from the randomisation process (individual) - D1a_cluster Domain 1a: risk of bias arising from the randomisation process (cluster) - D1b_cluster Domain 1b: risk of bias arising from the identification or recruitment of participants into clusters. - D1_combo D1_individual; or, D1a_cluster/D1b_cluster - D2 Domain 2: risk of bias due to deviations from the intended interventions (effect of assignment to the intervention). - D3 Domain 3: risk of bias due to missing outcome data. - D4 Domain 4: risk of bias in measurement of the outcome. - D5 Domain 5: risk of bias in selection of the reported result. - Overall_RoB Overall risk of bias. + low risk of bias - some concerns x high risk of bias / serious concerns xx very serious concerns (overall risk of bias only) NA not applicable (because it relates to cluster or individually randomised trials only) 5. METHODS ---------- This systematic review and network meta-analysis (NMA) searched MEDLINE, Embase, CINAHL, PsycINFO, CENTRAL and trial registries from inception to August 2021, without restrictions, for randomised controlled trials (RCTs) and cluster RCTs (follow-up ≥ 24 weeks) of community-based complex interventions for sustaining independence of older people (mean age 65+) living at home. Two authors independently extracted summary data. Interventions were coded, summarised and grouped. A random-effects NMA was used. We assessed risk of bias using the Cochrane RoB 2 tool. The protocol has been published (Crocker, et al. 2021) [1]. Details particularly relevant for understanding this dataset are provided below. ==Risk of bias assessment using ROB2== Two reviewers (from CB, TC, MJ, NL, MP) independently assessed risk of bias (RoB) in each result of interest from each included study, using version 2 of the Cochrane tool for assessing risk-of-bias in randomised trials (RoB 2) [2-4]. Disagreements were resolved by consensus between the reviewers or through discussion with the PMG. Our effect of interest was the effect of assignment to the intervention (‘intention-to-treat’ effect). For individually randomised studies, we assessed risk of bias in five domains: 1. bias arising from the randomization process; 2. bias due to deviations from intended interventions; 3. bias due to missing outcome data; 4. bias in measurement of the outcome; 5. bias in selection of the reported result. For cRCTs, we used the latest guidance [5] to assess identification/recruitment bias, and other issues such as loss of clusters [2]. This resulted in two domains of bias in place of domain 1: 1a, bias arising from the randomization process, and 1b, bias arising from the identification or recruitment of participants. Other details were integrated within the same domains as for individually-randomised trials. For each result, we made a judgement of high risk of bias, low risk of bias, or some concerns for each domain by answering the SQs with the supporting evidence and our reasons, then we used the algorithms to generate the suggested judgment and considered whether to override the judgment. We summarised our concerns about any risk of bias and reached an overall risk-of-bias judgement that was at least as severe as the most severe domain risk. Although we considered whether to elevate the overall severity to high risk for each assessment where multiple domains were rated as some concerns (and none as high) we did not elevate any as we did not judge the risks to substantially lower confidence in the result. We also judged whether a result at high risk of bias posed serious concerns (only one domain at high risk) or very serious concerns (more than one domain at high risk of bias or very serious concerns in relation to one domain). We used the ROB 2 Excel tools (version 8 for individually randomised studies, version 3 for cluster-randomised studies, available from https://www.riskofbias.info/welcome/rob-2-0-tool) to manage our assessments and check consistency between reviewers. Reviewers who conducted ROB 2 assessments had read the guidance and watched the Cochrane RoB 2: Learning Live webinar series. Some of the reviewers had previous experience of using the original Cochrane risk of bias tool (TC, NL, MJ) and others were new to assessing risk of bias (CB, MP). ==Evaluation of usage of ROB 2== We recorded details of the time taken to conduct assessments and reach consensus per study. ==RoB 2 assessments and resulting datasets== We conducted all the assessments between July 2021 and February 2022. 113 studies reported results of interest. Among these studies there were 860 results of interest for which we assessed risk of bias. However, 34 were unsuitable for inclusion and therefore 826 results are presented. Although 113 studies were assessed for risk of bias, not all are represented in the process (timings) data. Individual timings: Seven studies missing: four with missing timing data for at least one reviewer, and three with more than two reviewers involved in the assessment. Consensus timings: Eight studies with missing timing data for the consensus meeting. Resource for overall process: Fourteen studies not analysable for the overall process. Of the 106 studies with timing data for (only) two complete individual assessments, seven did not have timing data for the consensus meeting. ==References== [1] Crocker TF, Clegg A, Riley RD, Lam N, Bajpai R, Jordão M, et al. Community-based complex interventions to sustain independence in older people, stratified by frailty: a protocol for a systematic review and network meta-analysis. BMJ Open. 2021;11:e045637. [2] Higgins JPT, Savović J, Page MJ, Elbers RG, Sterne JAC. Chapter 8: Assessing risk of bias in a randomized trial. In: Higgins J, Thomas J, Chandler J, Cumpston M, Li T, Page M, et al., editors. Cochrane handbook for systematic reviews of interventions Version 63 (updated February 2022) Available from: www.training.cochrane.org/handbook/: Cochrane; 2022. [3] Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898. [4] Higgins JPT, Savović J, Page MJ, Sterne JAC, RoB2 Development Group. Revised Cochrane risk-of-bias tool for randomized trials (RoB 2). 2019. [5] Eldridge S, Campbell MK, Campbell MJ, Drahota AK, Giraudeau B, Reeves BC, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2): Additional considerations for cluster-randomized trials (RoB 2 CRT) (18 March 2021). 2021. 6. INCLUDED STUDIES ------------------- We included 129 studies in total (not all provided suitable information for inclusion in meta-analysis). 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Follow-up study of an urban family medicine home visit program. J Fam Pract 1988;26:307–12. Barenfeld E, Dahlin-Ivanoff S, Wallin L, Gustafsson S. Promoting aging migrants' capabilities: A randomized controlled trial concerning activities of daily living and self-rated health. AIMS Public Health 2018;5:173–88. https://doi.org/10.3934/publichealth.2018.2.173 Bernabei R, Landi F, Gambassi G, Sgadari A, Zuccala G, Mor V, et al. Randomised trial of impact of model of integrated care and case management for older people living in the community. BMJ 1998;316:1348–51. https://doi.org/10.1136/bmj.316.7141.1348 Bleijenberg N, Drubbel I, Schuurmans MJ, Dam HT, Zuithoff NP, Numans ME, et al. Effectiveness of a proactive primary care program on preserving daily functioning of older people: a cluster randomized controlled trial. J Am Geriatr Soc 2016;64:1779–88. https://doi.org/10.1111/jgs.14325 Blom J, den Elzen W, van Houwelingen AH, Heijmans M, Stijnen T, Van den Hout W, et al. Effectiveness and cost-effectiveness of a proactive, goal-oriented, integrated care model in general practice for older people. A cluster randomised controlled trial: Integrated Systematic Care for older People--the ISCOPE study. Age Ageing 2016;45:30–41. https://doi.org/10.1093/ageing/afv174 Borrows A, Holland R. Independent living centre occupational therapy (OT) versus routine community OT. Int J Ther Rehabil 2013;20:187–94. https://doi.org/10.12968/ijtr.2013.20.4.187 Botjes E. Methodebeschrijving EigenKrachtWijzer: Databank Effectieve sociale interventies Report: Movisie; 2013. URL: https://www.movisie.nl/sites/movisie.nl/files/2018-03/Methodebeschrijving-eigenkrachtwijzer.pdf (Accessed 17 May 2020). Bouman A, van Rossum E, Ambergen T, Kempen G, Knipschild P. Effects of a home visiting program for older people with poor health status: a randomized, clinical trial in The Netherlands. 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