D Moher’s research while affiliated with Ottawa Hospital Research Institute and other places

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Publications (137)


La declaration RECORD (Reporting of Studies Conducted Using Observational Routinely Collected Health Data) : directives pour la communication des etudes realisees a partir de donnees de sante collectees en routine
  • Article

February 2019

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64 Reads

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1 Citation

EI Benchimol

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L Smeeth

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[...]

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M Winker

Les données de santé collectées en routine et obtenues à des fins administratives et cliniques sans objectifs de recherche spécifiques a priori, sont de plus en plus utilisées pour la recherche. L'évolution rapide et la disponibilité de ces données ont révélé des problèmes qui ne sont pas abordés dans les outils d’évaluation existantes, tel que STROBE (Strengthening the Reporting of Observational Studies in Epidemiology). RECORD (REporting of studies Conducted using Observational Routinely collected health Data) a été développé pour combler ces lacunes. RECORD représente une extension de STROBE pour évaluer des éléments spécifiques aux études observationnelles en utilisant des données de santé collectées en routine. RECORD propose une liste de 13 éléments à évaluer concernant le titre, le résumé, l'introduction, les méthodes, les résultats et la section discussion des articles, ainsi que d'autres informations requises pour établir la qualité des études rapportées dans ces articles. Cet article méthodologique présente la liste des éléments d’évaluation ainsi que des informations explicatives pour réaliser et interpréter les évaluations. Des exemples sont également proposés pour chaque élément de la liste d’évaluation. Cet article présente une version en Français de l’outil d’évaluation RECORD. Accompagné de son site Internet (http://www.record-statement.org) son objectif est une large diffusion de l’outil d’évaluation RECORD pour faciliter sa mise en œuvre. Grâce à RECORD, les auteurs, les éditeurs de revues et les évaluateurs d’articles (c.-à-d., évaluation par les pairs) peuvent promouvoir la transparence des articles rapportant des études observationnelles originales à partir des données de santé collectées en routine.


Fig. 1 Flow of potential checklist items through CONSORT-SPI 2018 project
Table 1 The CONSORT-SPI 2018 checklist
Table 3 Items to report in journal or conference abstracts for social and psychological intervention trials [39]
Table 4 Items to report in the abstract for cluster randomised social and psychological intervention trials [33]
Table 5 Items to report in the main text for cluster randomised social and psychological intervention trials [33]
Reporting randomised trials of social and psychological interventions: The CONSORT-SPI 2018 Extension
  • Article
  • Full-text available

July 2018

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1,553 Reads

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109 Citations

Trials

BACKGROUND: Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018. METHODS: We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010. RESULTS: The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention. CONCLUSIONS: Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.

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Fig. 1 The CONSORT-SPI 2018 flow diagram
Abbreviations CI: Confidence interval; CONSORT: Consolidated Standards of Reporting Trials; CONSORT-SPI: Consolidated Standards of Reporting Trials for Social and Psychological Interventions; E&E: Explanation and Elaboration; RCT: Randomised controlled trial; SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials; UK: United Kingdom; US: United States
The CONSORT-SPI 2018 checklist (Continued)
Items to report in the abstract for cluster randomised social and psychological intervention trials [8]
Items to report in the main text for cluster randomised social and psychological intervention trials [8]
CONSORT-SPI 2018 Explanation and Elaboration: Guidance for reporting social and psychological intervention trials

July 2018

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598 Reads

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107 Citations

Trials

BACKGROUND: The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the CONSORT 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioural and social scientists report these studies transparently. METHODS: Following a systematic review of existing reporting guidelines, we conducted an online Delphi process to prioritise the list of potential items for the CONSORT-SPI 2018 checklist identified from the systematic review. Of 384 international participants, 321 (84%) participated in both rating rounds. We then held a consensus meeting of 31 scientists, journal editors, and research funders (March 2014) to finalise the content of the CONSORT-SPI 2018 checklist and flow diagram. RESULTS: CONSORT-SPI 2018 extends 9 items (14 including sub-items) from the CONSORT 2010 checklist, adds a new item (with 3 sub-items) related to stakeholder involvement in trials, and modifies the CONSORT 2010 flow diagram. This Explanation and Elaboration (E&E) document is a user manual to enhance understanding of CONSORT-SPI 2018. It discusses the meaning and rationale for each checklist item and provides examples of complete and transparent reporting. CONCLUSIONS: The CONSORT-SPI 2018 Extension, this E&E document, and the CONSORT website (www.consort-statement.org) are helpful resources for improving the reporting of social and psychological intervention RCTs.



Table 1 GRIPP2 long form (Continued) 
GRIPP2 reporting checklists: Tools to improve reporting of patient and public involvement in research

August 2017

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2,952 Reads

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474 Citations

Research Involvement and Engagement

Background While the patient and public involvement (PPI) evidence base has expanded over the past decade, the quality of reporting within papers is often inconsistent, limiting our understanding of how it works, in what context, for whom, and why. Objective To develop international consensus on the key items to report to enhance the quality, transparency, and consistency of the PPI evidence base. To collaboratively involve patients as research partners at all stages in the development of GRIPP2. Methods The EQUATOR method for developing reporting guidelines was used. The original GRIPP (Guidance for Reporting Involvement of Patients and the Public) checklist was revised, based on updated systematic review evidence. A three round Delphi survey was used to develop consensus on items to be included in the guideline. A subsequent face-to-face meeting produced agreement on items not reaching consensus during the Delphi process. Results One hundred forty-three participants agreed to participate in round one, with an 86% (123/143) response for round two and a 78% (112/143) response for round three. The Delphi survey identified the need for long form (LF) and short form (SF) versions. GRIPP2-LF includes 34 items on aims, definitions, concepts and theory, methods, stages and nature of involvement, context, capture or measurement of impact, outcomes, economic assessment, and reflections and is suitable for studies where the main focus is PPI. GRIPP2-SF includes five items on aims, methods, results, outcomes, and critical perspective and is suitable for studies where PPI is a secondary focus. Conclusions GRIPP2-LF and GRIPP2-SF represent the first international evidence based, consensus informed guidance for reporting patient and public involvement in research. Both versions of GRIPP2 aim to improve the quality, transparency, and consistency of the international PPI evidence base, to ensure PPI practice is based on the best evidence. In order to encourage its wide dissemination this article is freely accessible on The BMJ and Research Involvement and Engagement journal websites. Electronic supplementary material The online version of this article (doi:10.1186/s40900-017-0062-2) contains supplementary material, which is available to authorized users.


GRIPP2 reporting checklists: Tools to improve reporting of patient and public involvement in research

August 2017

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1,376 Reads

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1,495 Citations

The BMJ

BACKGROUND: While the patient and public involvement (PPI) evidence base has expanded over the past decade, the quality of reporting within papers is often inconsistent, limiting our understanding of how it works, in what context, for whom, and why. OBJECTIVE: To develop international consensus on the key items to report to enhance the quality, transparency, and consistency of the PPI evidence base. To collaboratively involve patients as research partners at all stages in the development of GRIPP2. METHODS: The EQUATOR method for developing reporting guidelines was used. The original GRIPP (Guidance for Reporting Involvement of Patients and the Public) checklist was revised, based on updated systematic review evidence. A three round Delphi survey was used to develop consensus on items to be included in the guideline. A subsequent face-to-face meeting produced agreement on items not reaching consensus during the Delphi process. RESULTS: One hundred forty-three participants agreed to participate in round one, with an 86% (123/143) response for round two and a 78% (112/143) response for round three. The Delphi survey identified the need for long form (LF) and short form (SF) versions. GRIPP2-LF includes 34 items on aims, definitions, concepts and theory, methods, stages and nature of involvement, context, capture or measurement of impact, outcomes, economic assessment, and reflections and is suitable for studies where the main focus is PPI. GRIPP2-SF includes five items on aims, methods, results, outcomes, and critical perspective and is suitable for studies where PPI is a secondary focus. CONCLUSIONS: GRIPP2-LF and GRIPP2-SF represent the first international evidence based, consensus informed guidance for reporting patient and public involvement in research. Both versions of GRIPP2 aim to improve the quality, transparency, and consistency of the international PPI evidence base, to ensure PPI practice is based on the best evidence.


Das RECORD-Statement zum Berichten von Beobachtungsstudien, die routinemäßig gesammelte Gesundheitsdaten verwenden = The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement

October 2016

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57 Reads

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15 Citations

Zeitschrift für Evidenz Fortbildung und Qualität im Gesundheitswesen

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist as well as explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included. This document, as well as the accompanying website and message board (http://www.record-statement.org), will improve the implementation and understanding of RECORD. By implementing RECORD, authors, journals editors, and peer reviewers can enhance transparency of research reporting.


Figure 1: Interventions eligible for network meta-analysis. Lines reflect where comparisons may exist between treatments. Which comparisons have been studied will be established by studies identified. Availability of outcomes can also impact network structure. Clinical experts have guided the network refinement
Comparison of pharmacological and non-pharmacological interventions to prevent delirium in critically ill patients: A protocol for a systematic review incorporating network meta-analyses

September 2016

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418 Reads

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11 Citations

Systematic Reviews

Background Delirium is characterized by acute changes in mental status including inattention, disorganized thinking, and altered level of consciousness, and is highly prevalent in critically ill adults. Delirium has adverse consequences for both patients and the healthcare system; however, at this time, no effective treatment exists. The identification of effective prevention strategies is therefore a clinical and research imperative. An important limitation of previous reviews of delirium prevention is that interventions were considered in isolation and only direct evidence was used. Our systematic review will synthesize all existing data using network meta-analysis, a powerful statistical approach that enables synthesis of both direct and indirect evidence. Methods We will search Ovid MEDLINE, CINAHL, Embase, PsycINFO, and Web of Science from 1980 to March 2016. We will search the PROSPERO registry for protocols and the Cochrane Library for published systematic reviews. We will examine reference lists of pertinent reviews and search grey literature and the International Clinical Trials Registry Platform for unpublished studies and ongoing trials. We will include randomized and quasi-randomized trials of critically ill adults evaluating any pharmacological, non-pharmacological, or multi-component intervention for delirium prevention, administered in or prior to (i.e., peri-operatively) transfer to the ICU. Two authors will independently screen search results and extract data from eligible studies. Risk of bias assessments will be completed on all included studies. To inform our network meta-analysis, we will first conduct conventional pair-wise meta-analyses for primary and secondary outcomes using random-effects models. We will generate our network meta-analysis using a Bayesian framework, assuming a common heterogeneity parameter across all comparisons, and accounting for correlations in multi-arm studies. We will perform analyses using WinBUGS software. DiscussionThis systematic review will address the existing knowledge gap regarding best practices for delirium prevention in critically ill adults by synthesizing evidence from trials of pharmacological, non-pharmacological, and multi-component interventions administered in or prior to transfer to the ICU. Use of network meta-analysis will clarify which delirium prevention strategies are most effective in improving clinical outcomes while causing least harm. The network meta-analysis is a novel approach and will provide knowledge users and decision makers with comparisons of multiple interventions of delirium prevention strategies. Systematic review registrationPROSPERO CRD42016036313


Randomized clinical trials of nonpharmacological treatments

April 2016

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132 Reads

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32 Citations

Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, and behavioral interventions. Unlike pharmacological treatments, these have no specific requirements for approval. Consequently, they can be widely proposed in clinical practice but may not have been adequately evaluated. This situation is an important barrier for the evaluation of the beneficial effects of these treatments and the conduct of clinical trials. Randomized Clinical Trials of Nonpharmacologic Treatments focuses on the methods for assessing nonpharmacological treatments, highlighting specific issues and trial design. Features: Chapters written by international experts in the field. Highlights specific issues in assessing nonpharmacological treatments in trials including: how to overcome the difficulties of blinding patients, care providers, and outcome assessors. the complexity of the intervention, the learning curve, and the clustering effect. placebos that can be used. issues of assessing harm and assessing the applicability of trials. Presents a variety of trial designs for nonpharmacological treatments-including cluster randomized controlled trials, expertise-based trials, pragmatic trials, and nonrandomized trials. Provides several examples of the planning, conduct, analyses, and reporting of trials in different fields, including surgery, technical interventions, medical devices, rehabilitation, psychotherapy, and behavioral interventions. Providing practical examples that underline these issues and solutions, this book is one of the first to exclusively explore this topic, discussing various categories of treatments, from surgical procedures to psychotherapy.



Citations (72)


... L es données de santé collectées en routine sont un sousproduit des opérations quotidiennes des systèmes de soins de santé, recueillies indépendamment de questions de recherche a priori spécifiques 1,2 . Un large éventail de sources (registres de maladies, données administratives de santé, bases de données de surveillance de la qualité/de la sécurité, dossiers médicaux électroniques et données de pharmacie) contiennent des données collectées en routine et ont à la fois l'exposi tion au médicament et les résultats cliniques qui pourraient être utiles en pharmacoépidémiologie 3,4 . ...

Reference:

La déclaration RECORD-PE (Reporting of Studies Conducted Using Observational Routinely Collected Health Data Statement for Pharmacoepdemiology) : directives pour la communication des études realisées à partir de données de santé observationelles collectées en routine en pharmacoépidémiologie
La declaration RECORD (Reporting of Studies Conducted Using Observational Routinely Collected Health Data) : directives pour la communication des etudes realisees a partir de donnees de sante collectees en routine
  • Citing Article
  • February 2019

... 15 A consensus-driven approach to NPI evaluation. Both researchers 5,7,11,[19][20][21] and health authorities 13,16,22 have called for the establishment of a comprehensive evaluation framework that systematically integrates all aspects of NPI assessment. To be effective, such a framework must be: i) consensus-based, ensuring alignment among all stakeholders, including researchers, healthcare users, healthcare practitioners, health operators, scientific societies, and health authorities; ii) comprehensive, covering all study types, from defining the intervention to evaluating its real-world implementation; iii) adapted to NPIs, recognizing their specific characteristics while adhering to established health research standards. ...

Randomized clinical trials of nonpharmacological treatments
  • Citing Book
  • April 2016

... This study follows the Consolidated Standards of Reporting Trials reporting guideline for social and psychological interventions. 23 The study formed part of a wider survey testing the acceptability of the intervention and the association of COVID-19-related fear with self-harm. 24,25 Participants One thousand and forty (n = 1040) participants were recruited online from a pre-existing database of YouGov panel members that is representative of the UK population. ...

Reporting randomised trials of social and psychological interventions: The CONSORT-SPI 2018 Extension

Trials

... This study is reported based on the Consolidated Standards of Reporting Randomised Controlled Trials (RCTs) of Social and Psychological Interventions (CONSORT-SPI) 2018 [22]. ...

CONSORT-SPI 2018 Explanation and Elaboration: Guidance for reporting social and psychological intervention trials

Trials

... Authors KR, SP and JV assessed the risk of bias in the randomized trials using the Cochrane Collaboration's tool (Higgins et al., 2011). Selection bias was assessed for aspects of random sequence generation and allocation concealment (Schulz et al., 2018). Performance bias was assessed for blinding of participants and personnel. ...

‘Allocation concealment’: the evolution and adoption of a methodological term
  • Citing Article
  • June 2018

Journal of the Royal Society of Medicine

... The practical utility of scholarship is indeed increasingly problematized given failure in confirming previously published findings. The problem is not only failure in applied intervention studies (Grant et al., 2013;Peterson, 1996), but the more general dissatisfaction with the public image of scholarship and the congruent reputational risks for individual scholars and academia in general (Anvari, & Lakens, 2018). For instance, Billheimer criticizes the tendency for context-free statements in applied science relying too much on presumably general laws -which is often of little value for the practical tasks (Billheimer, 2019). ...

Developing a reporting guideline for social and psychological intervention trials

Trials

... In addition to the National Statement (National Health and Medical Research Council and Council and Universities Australia, 2023) and National Framework (Australian Commission on Safety and Quality in Health Care, 2022), international resources, such as the 33-item SPIRIT statement (Chan et al., 2013), designed to provide an international standard for trial protocol development and reporting tools, such as the 16-item CONSORT-Harms (Junqueira et al., 2023) checklist for integration with the CONSORT-Outcomes (Butcher et al., 2022) or CONSORT-Social & Psychological Interventions (Montgomery et al., 2013), all promote the inclusion of harms data. Yet uptake is inconsistent (Junqueira et al., 2021). ...

Protocol for CONSORT-SPI: an extension for social and psychological interventions

Implementation Science

... To assess specific characteristics within the interventions, the TIDieR [30] (Template for Intervention Description and Replication) checklist was used to describe interventions, and if required, primary studies were consulted for additional relevant data not reported at review level. Methodological quality was assessed using AMSTAR 2 (A MeaSurement Tool to Assess systematic Reviews) [31]. ...

Die TIDieR Checkliste und Anleitung – ein Instrument für eine verbesserte Interventionsbeschreibung und Replikation
  • Citing Article
  • March 2016

Das Gesundheitswesen

... The final paper was shared with participants, and they were asked if they would like to be included as co-authors. The GRIPP2 checklist was used to ensure the quality of the report (appendix 6) [37]. The findings section below summarises the themes agreed. ...

GRIPP2 reporting checklists: Tools to improve reporting of patient and public involvement in research

The BMJ

... Reporting guidelines, for instance, could potentially be helpful to ensure transparent and consistent reporting of engagement [12]. Indeed, there are evidence-based reporting guidelines such as the Guidance for Reporting Involvement of Patients and the Public (GRIPP) and GRIPP2 checklists that can be used to improve the reporting of engagement methods, results and impact in health and social care research [13]. There are two forms of GRIPP2: the long form (GRIPP2-LF) and the short form (GRIPP2-SF) [13]. ...

GRIPP2 reporting checklists: Tools to improve reporting of patient and public involvement in research

Research Involvement and Engagement