CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration

Kwakkenbos, Linda; Imran, Mahrukh; McCall, Steve; McCord, Kimberly A; Fröbert, Ole; Hemkens, Lars G.; Zwarenstein, Merrick; Relton, Clare; Rice, Danielle B; Langan, Sinéad; Benchimol, Eric I.; Thabane, Lehana; Campbell, Marion K; Sampson, Margaret; Erlinge, David; Verkooijen, Helena M.; Moher, David; Boutron, Isabelle; Ravaud, Philippe; Nicholl, Jon; Uher, Rudolf; Sauvé, Maureen; Fletcher, John; Torgerson, David; Gale, Chris; Juszczak, Edmund; Thombs, Brett D.

doi:10.1136/bmj.n857

Cited by 80 publications

(65 citation statements)

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“…We have developed a consensus-driven extension to the CONSORT 2010 Statement for RCTs conducted using cohorts and routinely collected data (Kwakkenbos et al ). 24 CONSORT-ROUTINE contains minimum reporting requirements with appropriate flexibility as described in the Explanation & Elaboration part of our checklist document. This article described how we reached the final checklist and Explanation & Elaboration text and provides information on the decision-making process.…”

Section: Discussionmentioning

confidence: 99%

“… 23 This article describes, in detail, the consensus-based development process. The main aims of this article are to: (1) describe the methods and processes used in the development of the CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE; Kwakkenbos et al ) 24 and (2) describe decisions made to arrive at the final checklist and the accompanying Explanation & Elaboration statement.…”

Section: Introductionmentioning

confidence: 99%

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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)

et al. 2021

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ObjectivesRandomised 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.MethodsThe 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.Results27 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.ConclusionUptake 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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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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)

et al. 2021

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“…The trial has been registered ( ClinicalTrials.gov , NCT04246528 ), and the protocol follows Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) 2013 Statement reporting recommendations [ 31 ]. Reporting was also informed by Consolidated Standard of Reporting Trials statement extensions for nonpharmacologic trials [ 32 ] pragmatic trials [ 33 ], and trials conducted using cohorts and routinely collected data [ 34 ]. All items from the World Health Organization trial registration data set are available as Additional file 1 , and the SPIRIT checklist of recommended items to address in a clinical trial protocol is available as Additional file 2 .…”

Section: Methodsmentioning

confidence: 99%

The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial

Nordlund¹,

Henry²,

Kwakkenbos³

et al. 2021

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Background Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary). Methods This study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort (http://www.spinsclero.com/en/cohort) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited. Discussion The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge. Trial registration ClinicalTrials.govNCT04246528. Registered on 27 January 2020

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“…Routinedaten (z. B. aus Registern, Krankenhausdatenbanken oder Abrechnungsdaten) können die Durchführung von RCTs substanziell verbessern [ 8 , 30 , 31 ]. Statt aufwendig neue Dateninfrastrukturen aufzubauen, werden Daten benutzt, die sowieso erhoben werden.…”

Section: Herausforderungen: Andere Studiendesigns Oder Andere Randomisierte Studien?unclassified

“…B. Register oder Kohorten [ 31 ]) oder traditionelle Datenerhebung wird verknüpft mit Abfragen bestehender Datenquellen [ 32 ]. Mit Routinedaten können nicht nur Endpunkte gemessen, sondern auch Studienteilnehmer effizienter rekrutiert werden [ 8 ].…”

Section: Herausforderungen: Andere Studiendesigns Oder Andere Randomisierte Studien?unclassified

Nutzenbewertung digitaler Gesundheitsanwendungen – Herausforderungen und Möglichkeiten

Hemkens

2021

Bundesgesundheitsbl

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ZusammenfassungDigitale Gesundheitsanwendungen (DiGA) versprechen, die Gesundheit und medizinische Versorgung von Patienten zu verbessern. Dieser Beitrag gibt eine kurze Übersicht zur evidenzbasierten Nutzenbewertung und den Herausforderungen an die zugrunde liegende Evidenz als Voraussetzungen für eine optimale, patientenorientierte Entscheidungsfindung. Es werden klassische Konzepte des Studiendesigns, aktuelle Entwicklungen und innovative Ansätze beschrieben mit dem Ziel, zukünftige Entwicklungsfelder für innovative Studiendesigns und strategische Evaluationskonzepte für DiGA aufzuzeigen. Ein besonderer Schwerpunkt liegt auf der Anwendung pragmatischer Studiendesigns.Evidenzbasierte Nutzenbewertung hat fundamentale Anforderungen und Maßstäbe unabhängig von der Art der evaluierten Behandlungen. Zuverlässige Evidenz ist unverzichtbar. Eine schnelle, effiziente, zuverlässige und praxisrelevante Evaluation von DiGA gelingt nicht durch eine Hinwendung zu nichtrandomisierten Studien, sondern vielmehr durch bessere, pragmatische randomisierte Studien. Sie sind machbar und verbinden die Charakteristika von DiGA, klassische methodische Konzepte und neue Ansätze der Studiendurchführung. Routinedaten, kontaktarme Studiendurchführung („virtual trials“, „remote trials“) und digitale Biomarker fördern nützliche randomisierte Real-World-Evidenz als solide Evidenzbasis von DiGA. Eine kontinuierliche, lernende Evaluation im Versorgungsalltag mit in die Routine eingebetteten randomisierten Studiendesigns ist der Schlüssel zur nachhaltigen und effizienten Nutzenbewertung von DiGA und kann entscheidend für eine strategische Verbesserung der Gesundheitsversorgung sein.

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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

Cited by 80 publications

References 67 publications

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)

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)

The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial

Nutzenbewertung digitaler Gesundheitsanwendungen – Herausforderungen und Möglichkeiten

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