Developing a checklist for reporting research using simulated patient methodology (CRiSP): a consensus study.

Simulated patients are increasingly used to measure outcomes in health services but reporting is suboptimal. This study aims to create a checklist for the reporting of simulated patient (SP) methodology. This was a Delphi study. The authors of health service research studies using SP methodology were invited to participate. Round 1 questionnaire assessed the applicability of the TIDieR (Template for Intervention Description and Replication) reporting checklist for SP methodology and asked for rewording of/additional items. Responses were thematically analysed to generate Round 2 items in which participants rated each item for importance (seven-point Likert scale) and median, mode and IQR were calculated. In Round 3, participants were invited to rescore their Round 2 responses. Consensus was defined as an IQR ≤ 1 (Extremely important) and median ≤ 2 (Very important). All consensus items were considered for inclusion in the checklist. Similarly, worded items were rationalised and items not specific to SP methodology or other existing checklists were excluded. Twenty-nine authors participated in Round 1 and a further seven for Rounds 2 and 3. Twenty-six responses were analysed for Round 1, 30 for Round 2 and 28 for Round 3. There was consensus on 29 of 54 items in Round 2 and 45 of 63 items in Round 3. The final checklist comprised 28 items. A new reporting checklist to guide the reporting of studies, using simulated patients, complementary to CONSORT or STROBE, has been developed and will now be tested for usability.

Amaratunge S ，Harrison M ，Clifford R ，Seubert L ，Page A ，Bond C ... -  《-》

Refining the CRiSPHe (checklist for reporting research using a simulated patient methodology in Health): a Delphi study.

A recent applicability study highlighted the need for the existing checklist for reporting research using a simulated patient methodology (CRiSP) to be clearer and user-friendly. The aim of this study was to update the checklist to address these concerns. A fourth round of the Delphi consensus study, used in the original checklist development work, was conducted. Previous participants, who had expertise in SP methodology, were invited to complete a questionnaire including a list of 13 checklist items developed in the previous study and revised following applicability testing. Closed questions were analysed for frequency. Consensus was predefined as >80% agreement. All items were discussed in a roundtable meeting and further modified as necessary. Responses to open questions were content analysed. Twenty-one authors participated. There was a statistical consensus in 12 out of 13 modified checklist items. A final reporting checklist for studies in health research using SP methodology has been developed using a consensus approach. Further refinements may be needed to increase the generalizability of the checklist in different contexts.

Park JS ，Page A ，Clifford R ，Bond C ，Seubert L ... -  《-》

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).

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. 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. 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. 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.

Imran M ，Kwakkenbos L ，McCall SJ ，McCord KA ，Fröbert O ，Hemkens LG ，Zwarenstein M ，Relton C ，Rice DB ，Langan SM ，Benchimol EI ，Thabane L ，Campbell MK ，Sampson M ，Erlinge D ，Verkooijen HM ，Moher D ，Boutron I ，Ravaud P ，Nicholl J ，Uher R ，Sauvé M ，Fletcher J ，Torgerson D ，Gale C ，Juszczak E ，Thombs BD ... -  《-》

Development of the CLARIFY (CheckList stAndardising the Reporting of Interventions For Yoga) guidelines: a Delphi study.

The use of yoga as a therapeutic modality is increasing; however, a lack of transparent intervention reporting is restricting the dissemination and implementation of yoga research into clinical and community practice. The aim of this study was to develop a yoga-specific reporting guideline as an extension to existing reporting guidelines for randomised controlled trials, observational studies and case reports. Recognised international stakeholders in the design and conduct of yoga research were invited to contribute to the electronic Delphi survey. A four-round Delphi was conducted, whereby panellists rated selected items for their importance in the inclusion of yoga reporting guidelines, according to a 5-step Likert scale. A priori consensus for item inclusion was agreement of items as 'Very important' or 'Extremely important' by ≥80% of panellists. Non-consensus items were forwarded to subsequent rounds for re-rating. 53 experts in yoga research from 11 countries, primarily identifying as researchers (50%), allied health professionals (18.8%) and yoga professionals (12.5%), consented to participate in the Delphi. Of these, 48 completed Round 1 (91%), 43 completed Round 2 (81%), 39 completed Round 3 (74%) and 32 completed Round 4 (60%). Panellists reached consensus for inclusion on 21 items, grouped under 10 domains reflective of more generic intervention-based guidelines. The consensus-based 21-item CLARIFY (CheckList stAndardising the Reporting of Interventions For Yoga) checklist provides a minimum reporting template for researchers across a range of methodology designs. Use of these yoga-specific guidelines, in conjunction with the CLARIFY explanation and elaboration guidelines, will standardise the minimum level of detail required for transparent yoga intervention, facilitating the replication, dissemination and implementation of yoga research. Ongoing research will assess the uptake and impact of CLARIFY, to ensure these guidelines retain their relevance to the internationally growing field of yoga research.

Ward L ，Nault D ，Cramer H ，Moonaz S ... -  《-》

Consensus on Exercise Reporting Template (CERT): Modified Delphi Study.

Exercise interventions are often incompletely described in reports of clinical trials, hampering evaluation of results and replication and implementation into practice. The aim of this study was to develop a standardized method for reporting exercise programs in clinical trials: the Consensus on Exercise Reporting Template (CERT). Using the EQUATOR Network's methodological framework, 137 exercise experts were invited to participate in a Delphi consensus study. A list of 41 items was identified from a meta-epidemiologic study of 73 systematic reviews of exercise. For each item, participants indicated agreement on an 11-point rating scale. Consensus for item inclusion was defined a priori as greater than 70% agreement of respondents rating an item 7 or above. Three sequential rounds of anonymous online questionnaires and a Delphi workshop were used. There were 57 (response rate=42%), 54 (response rate=95%), and 49 (response rate=91%) respondents to rounds 1 through 3, respectively, from 11 countries and a range of disciplines. In round 1, 2 items were excluded; 24 items reached consensus for inclusion (8 items accepted in original format), and 16 items were revised in response to participant suggestions. Of 14 items in round 2, 3 were excluded, 11 reached consensus for inclusion (4 items accepted in original format), and 7 were reworded. Sixteen items were included in round 3, and all items reached greater than 70% consensus for inclusion. The views of included Delphi panelists may differ from those of experts who declined participation and may not fully represent the views of all exercise experts. The CERT, a 16-item checklist developed by an international panel of exercise experts, is designed to improve the reporting of exercise programs in all evaluative study designs and contains 7 categories: materials, provider, delivery, location, dosage, tailoring, and compliance. The CERT will encourage transparency, improve trial interpretation and replication, and facilitate implementation of effective exercise interventions into practice.

Slade SC ，Dionne CE ，Underwood M ，Buchbinder R ，Beck B ，Bennell K ，Brosseau L ，Costa L ，Cramp F ，Cup E ，Feehan L ，Ferreira M ，Forbes S ，Glasziou P ，Habets B ，Harris S ，Hay-Smith J ，Hillier S ，Hinman R ，Holland A ，Hondras M ，Kelly G ，Kent P ，Lauret GJ ，Long A ，Maher C ，Morso L ，Osteras N ，Peterson T ，Quinlivan R ，Rees K ，Regnaux JP ，Rietberg M ，Saunders D ，Skoetz N ，Sogaard K ，Takken T ，van Tulder M ，Voet N ，Ward L ，White C ... -  《-》