| 1. |
- Cord, Kimberly A. Mc., et al.
(författare)
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Reporting Transparency and Completeness in Trials : Paper 2 - Reporting of randomised trials using registries was often inadequate and hindered the interpretation of results
- 2022
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Ingår i: Journal of Clinical Epidemiology. - : Pergamon Press. - 0895-4356 .- 1878-5921. ; 141, s. 175-186
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: Registries are important data sources for randomised controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries.STUDY DESIGN AND SETTING: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed.RESULTS: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate).CONCLUSION: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials.
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| 2. |
- Haycock, Philip C., et al.
(författare)
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Association Between Telomere Length and Risk of Cancer and Non-Neoplastic Diseases A Mendelian Randomization Study
- 2017
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Ingår i: JAMA Oncology. - : American Medical Association. - 2374-2437 .- 2374-2445. ; 3:5, s. 636-651
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE: The causal direction and magnitude of the association between telomere length and incidence of cancer and non-neoplastic diseases is uncertain owing to the susceptibility of observational studies to confounding and reverse causation. OBJECTIVE: To conduct a Mendelian randomization study, using germline genetic variants as instrumental variables, to appraise the causal relevance of telomere length for risk of cancer and non-neoplastic diseases. DATA SOURCES: Genomewide association studies (GWAS) published up to January 15, 2015. STUDY SELECTION: GWAS of noncommunicable diseases that assayed germline genetic variation and did not select cohort or control participants on the basis of preexisting diseases. Of 163 GWAS of noncommunicable diseases identified, summary data from 103 were available. DATA EXTRACTION AND SYNTHESIS: Summary association statistics for single nucleotide polymorphisms (SNPs) that are strongly associated with telomere length in the general population. MAIN OUTCOMES AND MEASURES: Odds ratios (ORs) and 95% confidence intervals (CIs) for disease per standard deviation (SD) higher telomere length due to germline genetic variation. RESULTS: Summary data were available for 35 cancers and 48 non-neoplastic diseases, corresponding to 420 081 cases (median cases, 2526 per disease) and 1 093 105 controls (median, 6789 per disease). Increased telomere length due to germline genetic variation was generally associated with increased risk for site-specific cancers. The strongest associations (ORs [ 95% CIs] per 1-SD change in genetically increased telomere length) were observed for glioma, 5.27 (3.15-8.81); serous low-malignant-potential ovarian cancer, 4.35 (2.39-7.94); lung adenocarcinoma, 3.19 (2.40-4.22); neuroblastoma, 2.98 (1.92-4.62); bladder cancer, 2.19 (1.32-3.66); melanoma, 1.87 (1.55-2.26); testicular cancer, 1.76 (1.02-3.04); kidney cancer, 1.55 (1.08-2.23); and endometrial cancer, 1.31 (1.07-1.61). Associations were stronger for rarer cancers and at tissue sites with lower rates of stem cell division. There was generally little evidence of association between genetically increased telomere length and risk of psychiatric, autoimmune, inflammatory, diabetic, and other non-neoplastic diseases, except for coronary heart disease (OR, 0.78 [ 95% CI, 0.67-0.90]), abdominal aortic aneurysm (OR, 0.63 [ 95% CI, 0.49-0.81]), celiac disease (OR, 0.42 [ 95% CI, 0.28-0.61]) and interstitial lung disease (OR, 0.09 [ 95% CI, 0.05-0.15]). CONCLUSIONS AND RELEVANCE: It is likely that longer telomeres increase risk for several cancers but reduce risk for some non-neoplastic diseases, including cardiovascular diseases.
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| 3. |
- Imran, Mahrukh, et al.
(författare)
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Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)
- 2021
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 11:4
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.METHODS: The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.RESULTS: 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.CONCLUSION: Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.
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| 4. |
- Imran, Mahrukh, et al.
(författare)
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Reporting Transparency and Completeness in Trials : Paper 3 - Trials conducted using administrative databases do not adequately report elements related to use of databases
- 2022
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Ingår i: Journal of Clinical Epidemiology. - : Pergamon Press. - 0895-4356 .- 1878-5921. ; 141, s. 187-197
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: We evaluated reporting completeness and transparency in randomised controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.STUDY DESIGN AND SETTING: MEDLINE and the Cochrane Methodology Register were searched (2011 and 2018). Eligible RCTs used administrative databases for identifying eligible participants or collecting outcomes. We evaluated reporting based on CONSORT-ROUTINE, which modified eight items from CONSORT 2010 and added five new items.RESULTS: Of 33 included trials (76% used administrative databases for outcomes, 3% for identifying participants, 21% both), most were conducted in the United States (55%), Canada (18%), or the United Kingdom (12%). Of eight items modified in the extension; six were adequately reported in a majority (>50%) of trials. For the CONSORT-ROUTINE modification portion of those items, three items were reported adequately in >50% of trials, two in <50%, two only applied to some trials, and one only had wording modifications and was not evaluated. For five new items, four that address use of routine data in trials were reported inadequately in most trials.CONCLUSION: How administrative data are used in trials is often sub-optimally reported. CONSORT-ROUTINE uptake may improve reporting.
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| 5. |
- Juszczak, Edmund, et al.
(författare)
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Introducing the CONsolidated Standards of Reporting Trials (CONSORT) statement for randomised controlled trials (RCTs) using cohorts and routinely collected health data
- 2019
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Ingår i: Trials. - : BMC. - 1745-6215. ; 20:Suppl. 1, s. 131-131
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Background: Randomised controlled trials (RCTs) are increasingly being conducted using existing sources of data, such as cohorts, administrative databases, disease registries and electronic health records. RCTs conducted using existing data sources require additional information to be reported. This reporting guideline is an extension of the 2010 version of the Consolidated Standards of Reporting Trials (CONSORT) Statement for RCTs using cohorts and routinely collected health data.Methods: A long-list of potential items for the checklist was identified through two methods: firstly, modifications to the current CONSORT checklist were generated using existing reporting guidelines, including the Reporting of Observational Studies in Epidemiology (STROBE) and REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Secondly, ascoping review of RCTs conducted in the last decade using cohorts and routinely collected health data facilitated the modification and identification of other potential items. Using the long-list, a three-stage Delphi exercise was conducted to assess the importance of each item for inclusion in the final extension checklist, which was finalised at a face-to-face meeting of experts.Results: A long-list of 27 items was created and 125 experts registered for the three-round Delphi exercise (92, 77 and 62 experts participated in each round respectively). Consensus was reached on 21 out of 27 items. The results of the Delphi exercise informed a face-to-face consensus meeting in May 2019; core items to be included in the extension checklist were finalised at this meeting. Corresponding explanations of extensions and new items with examples of good reporting were developed subsequently.Conclusion: The guideline checklist can facilitate transparent reporting of RCTs using cohorts and routinely collected health data, to assist evaluations of rigour and reproducibility, enhance understanding of the methodology, and make the results more useful for clinicians, journal editors, reviewers, guideline authors, and funders.
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| 6. |
- Kwakkenbos, Linda, et al.
(författare)
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CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) : checklist with explanation and elaboration
- 2021
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Ingår i: The BMJ. - : BMJ Publishing Group Ltd. - 1756-1833 .- 0959-8146. ; 373
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Tidskriftsartikel (refereegranskat)abstract
- Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the trial and to facilitate recruitment, to deliver an embedded intervention, to collect trial outcome data, or a combination of these purposes. This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). The extension was developed to look at the unique characteristics of trials conducted with these types of data with the goal of improving reporting quality in the long term by setting standards early in the process of uptake of these trial designs. The extension was developed with a sequential approach, including a Delphi survey, a consensus meeting, and piloting of the checklist. The checklist was informed by the CONSORT 2010 statement and two reporting guidelines for observational studies, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement and the REporting of studies Conducted using Observational Routinely collected Data (RECORD) statement. The extension includes eight items modified from the CONSORT 2010 statement and five new items. Reporting items with explanations and examples are provided, including key aspects of trials conducted using cohorts or routinely collected data that require specific reporting considerations.
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| 7. |
- Kwakkenbos, Linda, et al.
(författare)
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Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data
- 2018
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 8:8
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Forskningsöversikt (refereegranskat)abstract
- Introduction: Randomised controlled trials (RCTs) conducted using cohorts and routinely collected health data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. The development of an extension of the CONsolidated Standards of Reporting Trials (CONSORT) statement for RCTs using cohorts and routinely collected health data is being undertaken with the goal of improving reporting quality by setting standards early in the process of uptake of these designs. To develop this extension to the CONSORT statement, a scoping review will be conducted to identify potential modifications or clarifications of existing reporting guideline items, as well as additional items needed for reporting RCTs using cohorts and routinely collected health data.Methods and analysis: In separate searches, we will seek publications on methods or reporting or that describe protocols or results from RCTs using cohorts, registries, electronic health records and administrative databases. Data sources will include Medline and the Cochrane Methodology Register. For each of the four main types of RCTs using cohorts and routinely collected health data, separately, two investigators will independently review included publications to extract potential checklist items. A potential item will either modify an existing CONSORT 2010, Strengthening the Reporting of Observational Studies in Epidemiology or REporting of studies Conducted using Observational Routinely collected health Data item or will be proposed as a new item. Additionally, we will identify examples of good reporting in RCTs using cohorts and routinely collected health data.Ethics and dissemination: The proposed scoping review will help guide the development of the CONSORT extension statement for RCTs conducted using cohorts and routinely collected health data.
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| 8. |
- McCall, Stephen J., et al.
(författare)
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Reporting Transparency and Completeness in Trials : Paper 4 - Reporting of randomised controlled trials conducted using routinely collected electronic records - room for improvement
- 2022
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Ingår i: Journal of Clinical Epidemiology. - : Pergamon Press. - 0895-4356 .- 1878-5921. ; 141, s. 198-209
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To describe characteristics of randomised controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.STUDY DESIGN: MEDLINE and Cochrane Methodology Register were searched for a sample of RCTs published from 2011-2018. Completeness of reporting was assessed in a random sample using a pre-defined coding form.RESULTS: 183 RCT publications were identified; 122 (67%) used EHRs to identify eligible participants, 139 (76%) used the EHR as part of the intervention and 137 (75%) to ascertain outcomes. When 60 publications were evaluated against the CONSORT 2010 item and the corresponding extension for the 8 modified items, four items were 'adequately reported' for the majority of trials. Five new reporting items were identified for the CONSORT-ROUTINE extension; when evaluated, one was 'adequately reported', three were reported 'inadequately or not at all', the other 'partially'. There were, however, some encouraging signs with adequate and partial reporting of many important items, including descriptions of trial design, the consent process, outcome ascertainment and interpretation.CONCLUSION: Aspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting.
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| 9. |
- Relton, Clare, et al.
(författare)
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Health System Trials
- 2019
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Ingår i: Trials. - : BMC. - 1745-6215. ; 20, s. 115-115
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Pragmatic randomised trials aim to provide evidence to support decisions by stakeholders in healthcare systems (patients, clinicians, funders, policy makers). The typical pragmatic trial recruits participantwho provide data for the trial using purpose built data collection systems. At the end of the trial–all is disbanded. This approach is costland frequently fails to recruit sufficiently large or representativsamples.Since the advent of electronic data, pragmatic trials are increasingly using routine health data collected from administrative, clinical and patient sources. A new group of trial designs have emerged which we describe as ‘Health System Trials’. These include Registry-based Randomised Controlled Trials (RRCTs), Electronic Health Record (EHR) Trials, Administrative Data (AD) Trials and Trials within Cohorts (TwiCs). These four designs purposefully utilise existing and/or newly created health system data structures for one or more trial activities: identifying potential trial participants, recruitment, randomisation, process and outcome data collection, etc. The process of informed consent is often spread out (staged) as occurs in routine healthcare especially with TwiCs designs.By utilising populations within health systems and the data that derives from their healthcare encounters, these trials efficiently recruit large representative populations and obtain both short and longerterm outcomes. These designs reduce the effort and cost of trials whilst improving the applicability of the trial results for decision makers in health systems.We discuss the opportunities for these types of trial designs to be integrated within health systems, enabling the continuous generation of knowledge that is an essential feature of learning health systems. CONSORT Reporting guidelines for Trials Using Cohorts and Routine Health Data are currently being developed. Drawing on development work for these guidelines we describe real world examples of ‘HealthSystem Trials’, including examples of both nascent vertical (disease focused) and horizontal (e.g. practice based) learning health systems.
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| 10. |
- Relton, Clare, et al.
(författare)
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Review of use of the Trials within Cohorts (TwiCs) design approach
- 2019
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Ingår i: Trials. - : BMC. - 1745-6215. ; 20:Suppl. 1, s. 112-113
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Introduction: Trials within Cohorts (TwiCs) is an innovative approach to the design and conduct of multiple randomised controlled trials (RCTs) (Relton et al, 2010). This approach utilises an observational cohort to recruit trial populations and obtain short and longer term outcomes. We describe what is currently known about the use of this design approach.Methods: An extension of the 2010 Consolidated Standards of Reporting Trials (CONSORT) Statements for RCTs using cohorts and/or routinely collected health data is in development, supported by a scoping review that includes publications of methods or reports ofprotocols or results from RCTs using cohorts, registries, electronic health records and administrative databases. Data sources for this scoping review included Medline and Cochrane Methodology Register and were limited to English language.This review of use of the TwiCs approach uses publications of methods or reports of protocols or results from RCTs that use cohorts to recruit identified in the scoping review. This is supplemented with information from topic experts.We report: (i) types of cohorts (setting, population, condition/ disease area), (ii) how the cohorts are utilised (identifying potential trial participants, recruitment, randomisation, process and outcome data collection including bespoke and/or routine health record data, types of trials conducted/ planned), (iii) approaches to informed consent, e.g. staged approach (Young-Afat et al, 2016), and (iv) any purported and/or real study design (in)efficiencies.Timing of Potential Results: Early results indicate 75+ eligible full text articles, including 23 trial protocols and 23 articles reporting the results of trials using cohorts. Full results will be available in August 2019 and presented at the conference.Potential Relevance and Impact: Standard approaches to trial design are often costly and frequently fail to recruit sufficiently large or representative samples. This review will help provide information on the use and potential (in)efficiency of the TwiCs approach
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