scholarly journals A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE)

2021 ◽  
Vol 4 ◽  
pp. 82
Author(s):  
Megan McCarthy ◽  
Linda O'Keeffe ◽  
Paula R. Williamson ◽  
Matthew R. Sydes ◽  
Amanda Farrin ◽  
...  
Keyword(s):  
Reporting Guidelines ◽  
Rapid Review ◽  
Quality Of Reporting ◽  
Routinely Collected Data ◽  
Steering Group ◽  
Delphi Exercise ◽  
Trial Protocols ◽  
Randomised Controlled ◽  
Stage 1 ◽  
The Cost

Background: Protocols are an essential document for conducting randomised controlled trials (RCTs). However, the completeness of the information provided is often inadequate. To help improve the content of trial protocols, an international group of stakeholders published the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Initiative in 2013. Presently, there is increasing use of cohorts and routinely collected data (RCD) for RCTs because these data have the potential to improve efficiencies by facilitating recruitment, simplifying, and reducing the cost of data collection. Reporting guidelines have been shown to improve the quality of reporting, but there is currently no specific SPIRIT guidance on protocols for trials conducted using cohorts and RCD. This protocol outlines steps for developing SPIRIT-ROUTINE, which aims to address this gap by extending the SPIRIT guidance to protocols for trials conducted using cohorts and RCD.  Methods: The development of the SPIRIT-ROUTINE extension comprises five stages. Stage 1 consists of a project launch and a meeting to finalise the membership of the steering group and scope of the extension. In Stage 2, a rapid review will be performed to identify possible modifications to the original SPIRIT 2013 checklist. Other key reporting guidelines will be reviewed to identify areas where additional items may be needed, such as the Consolidated Standards of Reporting Trials (CONSORT) extension for trials conducted using cohorts and RCD (CONSORT-ROUTINE). Stage 3 will involve an online Delphi exercise, consisting of two rounds and involving key international stakeholders to gather feedback on the preliminary checklist items. In Stage 4, a consensus meeting of the SPIRIT-ROUTINE steering group will finalise the items to include in the extension. Stage 5 will involve the publication preparation and dissemination of the final checklist.  Conclusion: The SPIRIT-ROUTINE extension will contribute to improving design of trials using cohorts and RCD and transparency of reporting.

scholarly journals The quality of intervention reporting in trials of therapeutic exercise for hip osteoarthritis: a secondary analysis of a systematic review

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Louise C. Burgess ◽  
Thomas W. Wainwright ◽  
Khara A. James ◽  
Johan von Heideken ◽  
Maura D. Iversen
Keyword(s):  
Systematic Review ◽  
Secondary Analysis ◽  
Internal Validity ◽  
Hip Osteoarthritis ◽  
Therapeutic Exercise ◽  
Quality Of Reporting ◽  
Effective Interventions ◽  
Randomised Controlled ◽  
Intervention Reporting

Abstract Background Therapeutic exercise is recommended as a core treatment for hip osteoarthritis (HOA). Whilst it is widely accepted that exercise can improve pain and disability, optimal type and dose of exercise are yet to be agreed upon. This may, in part, be attributed to the wide variation and inadequate reporting of interventions within the literature. This study evaluates the quality of intervention reporting among trials of therapeutic exercise in HOA. Methods Randomised controlled trials (RCTs) were sourced in a systematic review, completed in August 2020. Two raters independently used the Template for Intervention Description and Replication (TIDieR) and Consensus on Exercise Reporting Template (CERT) to evaluate intervention reporting. Correlations between quality assessment scores and CERT and TIDieR scores evaluated the relationship between internal validity and external applicability. The year of publication was compared to the quality of reporting scores. Results Fourteen RCTs were included in the analysis. On average, studies were awarded 9.43 ± 1.95 out of 12 points for the TIDieR checklist (range 4–12) and 13.57 ± 4.01 out of 19 points for the CERT (range 5–19). Pearson’s correlation coefficient suggested that the quality of reporting had improved over time and that there was a fair, positive relationship between internal validity and external applicability. Discussion Whilst the quality of intervention reporting is improving, many RCTs of therapeutic exercise in HOA lack the detail necessary to allow accurate evaluation and replication. Researchers are encouraged to utilise the standardised reporting guidelines to increase the translation of effective interventions into clinical practice.

scholarly journals Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048178
Author(s):  
Katie Mellor ◽  
Saskia Eddy ◽  
Nicholas Peckham ◽  
Christine M Bond ◽  
Michael J Campbell ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
A Priori ◽  
Pilot Trial ◽  
Public Library ◽  
Feasibility Studies ◽  
Methodological Review ◽  
Pilot Trials ◽  
Trial Protocols ◽  
Randomised Controlled

ObjectivesPrespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports.Study designMethodological review.MethodsWe searched four journals through PubMed: British Medical Journal Open, Pilot and Feasibility Studies, Trials and Public Library of Science One. Eligible publications reported external randomised pilot trial protocols or results, were published between January 2018 and December 2019 and reported progression criteria. We double data extracted 25% of the included publications. Here we report the progression criteria characteristics.ResultsWe included 160 publications (123 protocols and 37 completed trials). Recruitment and retention were the most frequent indicators contributing to progression criteria. Progression criteria were mostly reported as distinct thresholds (eg, achieving a specific target; 133/160, 83%). Less than a third of the planned and completed pilot trials that included qualitative research reported how these findings would contribute towards progression criteria (34/108, 31%). The publications seldom stated who established the progression criteria (12/160, 7.5%) or provided rationale or justification for progression criteria (44/160, 28%). Most completed pilot trials reported the intention to proceed to a definitive trial (30/37, 81%), but less than half strictly met all of their progression criteria (17/37, 46%). Prepublication peer reviewer reports were available for 153/160 publications (96%). Peer reviewer reports for 86/153 (56%) publications mentioned progression criteria, with peer reviewers of 35 publications commenting that progression criteria appeared not to be specified.ConclusionsMany external randomised pilot trial publications did not adequately report or propose prespecified progression criteria to inform whether to proceed to a future definitive randomised controlled trial.

scholarly journals Cost-effectiveness analysis of an intimate partner violence prevention intervention targeting men, women and couples in rural Ethiopia: evidence from the Unite for a Better Life randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042365
Author(s):  
Jessica Leight ◽  
Negussie Deyessa ◽  
Vandana Sharma
Keyword(s):  
Intimate Partner Violence ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Partner Violence ◽  
Controlled Trial ◽  
Intimate Partner ◽  
Community Level ◽  
Secondary Outcome ◽  
Randomised Controlled ◽  
The Cost

ObjectivesExperience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples.DesignWe use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously.SettingUBL was implemented in rural southern Ethiopia between 2013 and 2015.ParticipantsThe randomised controlled trial included 6770 households in 64 villages.InterventionsUBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships.Primary and secondary outcome measuresThis paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted.ResultsThe estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries.ConclusionsUBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains.Trial registration numberNCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry)

A Systematic Review of Cost-Effectiveness Analyses Alongside Randomised Controlled Trials of Acupuncture

2012 ◽  
Vol 30 (4) ◽  
pp. 273-285 ◽  
Author(s):  
Song-Yi Kim ◽  
Hyangsook Lee ◽  
Younbyoung Chae ◽  
Hi-Joon Park ◽  
Hyejung Lee
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Randomised Controlled Trials ◽  
Risk Of Bias ◽  
Economic Evaluations ◽  
Controlled Trials ◽  
German Studies ◽  
Life Years ◽  
Randomised Controlled ◽  
The Cost

Objective To summarise the evidence on the cost-effectiveness of acupuncture. Methods We identified full economic evaluations such as cost-effectiveness analysis (CEA), cost-utility analysis (CUA) and cost-benefit analysis (CBA) alongside randomised controlled trials (RCTs) that assessed the consequences and costs of acupuncture for any medical condition. Eleven electronic databases were searched up to March 2011 without language restrictions. Eligible RCTs were assessed using the Cochrane criteria for risk of bias and a modified version of the checklist for economic evaluation. The general characteristics and the results of each economic analysis such as incremental cost-effectiveness ratios (ICERs) were extracted. Results Of 17 included studies, nine were CUAs that measured quality-adjusted life years (QALYs) and eight were CEAs that assessed effectiveness of acupuncture based on improvements in clinical symptoms. All CUAs showed that acupuncture with or without usual care was cost-effective compared with waiting list control or usual care alone, with ICERs ranging from ¢3011/QALY (dysmenorrhoea) to ¢22 298/QALY (allergic rhinitis) in German studies, and from £3855/QALY (osteoarthritis) to £9951/QALY (headache) in UK studies. In the CEAs, acupuncture was beneficial at a relatively low cost in six European and Asian studies. All CUAs were well-designed with a low risk of bias, but this was not the case for CEAs. Conclusions Overall, this review demonstrates the cost-effectiveness of acupuncture. Despite such promising results, any generalisation of these results needs to be made with caution given the diversity of diseases and the different status of acupuncture in the various countries.

Improved quality of reporting safety data of medication in paediatric randomised controlled trials

2021 ◽  
pp. archdischild-2020-321197
Author(s):  
Taco Jan Prins ◽  
Corine Rollema ◽  
Eric van Roon ◽  
Tjalling de Vries
Keyword(s):  
Adverse Events ◽  
Randomised Controlled Trials ◽  
Safety Data ◽  
Drug Event ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Event Reporting ◽  
The Past ◽  
Randomised Controlled

ObjectiveEvaluating the reporting of safety data of medication in paediatric randomised controlled trials (RCTs) in 2017–2018 compared with our earlier study.DesignLiterature search with a systemic appraisal of adverse drug event reporting.Main outcome measuresQuality of reporting of safety data using Consolidated Standards of Reporting Trials (CONSORT) and Ioannidis scores in paediatric drug RCTs. The CONSORT score consists of nine recommendations of the CONSORT Group issued to improve the quality of reporting adverse events. The Ioannidis score is based on these advices. We considered a CONSORT score of at least 6 and an Ioannidis score of at least 3 as sufficient.ResultsWe reviewed 100 RCTs published in 2017 and 2018. Ninety-four (94%) articles mentioned adverse events compared with 78% in the earlier study. Fifty-seven per cent used a standardised method for reporting adverse events compared with 34% in our earlier study. In 26 of the articles, the expected adverse events were defined, and 27 articles had a preset standardised scale for adverse events. Of these, 62 articles (62%) had a CONSORT score of 6 or higher compared with 18% in 2010. In the present study, 67% had an Ioannidis score of 3 or higher, whereas in the earlier study this was 29%. Both differences are statistically significant (p<0.05).ConclusionsReporting safety data in paediatric RCTs has improved over the past 10 years. However, there is still room for improvement and for further improvement. Authors and editors should give more attention to methods for collecting, reporting and presenting safety data of RCTs in studies and manuscripts.

Positive behavioural support for children and adolescents with learning disabilities and behaviour that challenges: an initial exploration of service use and costs

2016 ◽  
Vol 21 (4) ◽  
pp. 169-180 ◽  
Author(s):  
Valentina Iemmi ◽  
Martin Knapp ◽  
Caroline Reid ◽  
Catherine Sholl ◽  
Monique Ferdinand ◽  
...  
Keyword(s):  
Learning Disabilities ◽  
Children And Adolescents ◽  
Service Use ◽  
Potential Cost ◽  
Content Type ◽  
Total Cost ◽  
Behavioural Support ◽  
Delphi Exercise ◽  
The Cost

Purpose Positive behavioural support has been considered as a valuable alternative to residential care for children and adolescents with learning disabilities and behaviour that challenges. While recent evidence suggests it has a positive impact on behaviour and carer ability to cope, there is little evidence of its economic costs or benefits. The paper aims to discuss this issue. Design/methodology/approach An exploratory cross-sectional study was conducted to evaluate the cost of providing positive behavioural support to ten children and adolescents with learning disabilities and behaviour that challenges living in the community in Ealing, West London. Comparison was also made with the cost estimate of possible alternative support packages for children and adolescents with learning disabilities and behaviour that challenges in the UK, as obtained through a Delphi exercise. Findings Total cost of services per child was £1,454 per week for young people supported short-term, and £1,402 supported long-term. Children and adolescents were making use of a range of social care, education and health services. Over the full sample, half of the total cost was accounted for by education services. The Delphi exercise estimated the weekly cost of residential-based care as more expensive than the cost of community-based care for children and adolescents with learning disabilities and behaviour that challenges. At the end of the ITSBS, all ten children and adolescents initially at risk of imminent residential placement were living in the community with less service-intensive and less expensive support. This suggests that avoiding residential-based care could reduce costs in the long term. Originality/value Positive behavioural support has potential to support people with learning disabilities and behaviour that challenges in the community, leading to potential cost advantages. However, this is a small study and more robust research is needed.

scholarly journals The Evaluation of home medication review for patients with type 2 diabetes mellitus by community pharmacists: a randomised controlled trial

2021 ◽  
Vol 19 (3) ◽  
pp. 2397
Author(s):  
M. Rozaini Rosli ◽  
Chin F. Neoh ◽  
David B. Wu ◽  
Nazariah W. Hassan ◽  
Mahani Mahmud ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Community Pharmacists ◽  
Anthropometric Data ◽  
Anthropometric Parameters ◽  
Home Medication ◽  
Medication Wastage ◽  
Randomised Controlled ◽  
The Cost

Background: Successful diabetes treatment requires commitment and understanding of disease management by the patients. Objective: This trial aimed to evaluate the programme effectiveness of home medication review by community pharmacists (HMR-CP) in optimising diabetes care and reducing medication wastage. Methods: A randomised controlled trial was conducted on 166 patients with Type 2 Diabetes Mellitus (T2DM) who were randomly assigned to the intervention or control groups. The intervention group received HMR-CP at 0-month, 3-month, and 6-month. The primary outcome was haemoglobin A1c (HbA1c) while clinical outcomes, anthropometric data, and humanistic outcomes were the secondary outcomes. For the intervention group, drug-related problems (DRP) were classified according to the Pharmaceutical Care Network Europe Foundation (PCNE). Medication adherence was determined based on the Pill Counting Adherence Ratio (PCAR). The cost of medication wastage was calculated based on the total missed dose by the T2DM patients multiplied by the cost of medication. General linear model and generalised estimating equations were used to compare data across the different time-points within and between the groups, respectively. Results: No significant difference was observed in the demographic and anthropometric data at baseline between the two groups except for fasting blood glucose (FBG). There was a significant reduction in the HbA1c (-0.91%) and FBG (-1.62mmol/L) over the study period (p<0.05). A similar observation was noted in diastolic blood pressure (DBP) and total cholesterol (TC) but not in high-density lipoprotein (HDL), and anthropometric parameters. Both utility value and Michigan Diabetes Knowledge Test (MDKT) scores increased significantly over time. As for the intervention group, significant changes in PCAR (p<0.001) and the number of DRP (p<0.001) were noted. Conclusions: HMR-CP significantly improved the glycaemic control, QoL, medication adherence, and knowledge of T2DM patients as well as reduced the number of DRP and cost of medication wastage. However, the impact of HMR-CP on certain clinical and anthropometric parameters remains inconclusive and further investigation is warranted. 

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