Standardized Protocol Items Recommendations for Observational Studies (SPIROS) for Observational Study Protocol Reporting Guidelines: Protocol for a Delphi Study (Preprint)

BACKGROUND Approximately 90% of currently published clinical and public health research is in the form of observational studies. Having a detailed and registered study protocol prior to data collection is important in any empirical study. Without this, there is no reliable way to assess the occurrence of publication bias, outcome reporting bias, and other protocol deviations. However, there is currently no solid guidance available on the information that a protocol for an observational study should contain. OBJECTIVE The aim of this study is to formulate the Standardized Protocol Items Recommendations for Observational Studies (SPIROS) reporting guidelines, which focus on 3 main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies. METHODS A scoping review of published protocol papers of observational studies in epidemiology will identify candidate items for the SPIROS reporting guidelines. The list of items will be extended with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist items and recommendations from the SPIROS steering committee. This long list serves as the basis for a 2-round Delphi survey among experts to obtain consensus on which items to include. Each candidate item from the long list will be rated on a 5-point Likert scale to assess relevance for inclusion in the SPIROS reporting guidelines. Following the Delphi survey, an expert-driven consensus workshop will be convened to finalize the reporting guidelines. RESULTS A scoping review of published observational study protocols has been completed, with 59 candidate items identified for inclusion into the Delphi survey, itself launched in early 2020. CONCLUSIONS This project aims to improve the timeliness, completeness, and clarity of study protocols of observational studies in analytical epidemiology by producing expert-based recommendations of items to be addressed. These reporting guidelines will facilitate and encourage researchers to prepare and register study protocols of sufficient quality prior to data collection in order to improve the transparency, reproducibility, and quality of observational studies. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/17864

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Standardized Protocol Items Recommendations for Observational Studies (SPIROS) for Observational Study Protocol Reporting Guidelines: Protocol for a Delphi Study

JMIR Research Protocols ◽

10.2196/17864 ◽

2020 ◽

Vol 9 (10) ◽

pp. e17864

Author(s):

Raman Mahajan ◽

Sakib Burza ◽

Lex M Bouter ◽

Klaas Sijtsma ◽

André Knottnerus ◽

...

Keyword(s):

Data Collection ◽

Observational Study ◽

Study Protocol ◽

Scoping Review ◽

Delphi Study ◽

Observational Studies ◽

Delphi Survey ◽

Reporting Guidelines ◽

Standardized Protocol ◽

Study Protocols

Background Approximately 90% of currently published clinical and public health research is in the form of observational studies. Having a detailed and registered study protocol prior to data collection is important in any empirical study. Without this, there is no reliable way to assess the occurrence of publication bias, outcome reporting bias, and other protocol deviations. However, there is currently no solid guidance available on the information that a protocol for an observational study should contain. Objective The aim of this study is to formulate the Standardized Protocol Items Recommendations for Observational Studies (SPIROS) reporting guidelines, which focus on 3 main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies. Methods A scoping review of published protocol papers of observational studies in epidemiology will identify candidate items for the SPIROS reporting guidelines. The list of items will be extended with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist items and recommendations from the SPIROS steering committee. This long list serves as the basis for a 2-round Delphi survey among experts to obtain consensus on which items to include. Each candidate item from the long list will be rated on a 5-point Likert scale to assess relevance for inclusion in the SPIROS reporting guidelines. Following the Delphi survey, an expert-driven consensus workshop will be convened to finalize the reporting guidelines. Results A scoping review of published observational study protocols has been completed, with 59 candidate items identified for inclusion into the Delphi survey, itself launched in early 2020. Conclusions This project aims to improve the timeliness, completeness, and clarity of study protocols of observational studies in analytical epidemiology by producing expert-based recommendations of items to be addressed. These reporting guidelines will facilitate and encourage researchers to prepare and register study protocols of sufficient quality prior to data collection in order to improve the transparency, reproducibility, and quality of observational studies. International Registered Report Identifier (IRRID) PRR1-10.2196/17864

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Strategies for involving patients and the public in scaling-up initiatives in health and social services: protocol for a scoping review and Delphi survey

Systematic Reviews ◽

10.1186/s13643-021-01597-6 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Ali Ben Charif ◽

◽

Karine V. Plourde ◽

Sabrina Guay-Bélanger ◽

Hervé Tchala Vignon Zomahoun ◽

...

Keyword(s):

Social Services ◽

Scoping Review ◽

Delphi Study ◽

Public Involvement ◽

Scale Up ◽

Scaling Up ◽

Delphi Survey ◽

The Public ◽

Health And Social Services ◽

Scoping Reviews

Abstract Background The scale-up of evidence-based innovations is required to reduce waste and inequities in health and social services (HSS). However, it often tends to be a top-down process initiated by policy makers, and the values of the intended beneficiaries are forgotten. Involving multiple stakeholders including patients and the public in the scaling-up process is thus essential but highly complex. We propose to identify relevant strategies for meaningfully and equitably involving patients and the public in the science and practice of scaling up in HSS. Methods We will adapt our overall method from the RAND/UCLA Appropriateness Method. Following this, we will perform a two-prong study design (knowledge synthesis and Delphi study) grounded in an integrated knowledge translation approach. This approach involves extensive participation of a network of stakeholders interested in patient and public involvement (PPI) in scaling up and a multidisciplinary steering committee. We will conduct a systematic scoping review following the methodology recommended in the Joanna Briggs Institute Reviewers Manual. We will use the following eligibility criteria: (1) participants—any stakeholder involved in creating or testing a strategy for PPI; (2) intervention—any PPI strategy proposed for scaling-up initiatives; (3) comparator—no restriction; (4) outcomes: any process or outcome metrics related to PPI; and (5) setting—HSS. We will search electronic databases (e.g., Medline, Web of Science, Sociological Abstract) from inception onwards, hand search relevant websites, screen the reference lists of included records, and consult experts in the field. Two reviewers will independently select and extract eligible studies. We will summarize data quantitatively and qualitatively and report results using the PRISMA extension for Scoping Reviews (PRISMA-ScR) checklist. We will conduct an online Delphi survey to achieve consensus on the relevant strategies for PPI in scaling-up initiatives in HSS. Participants will include stakeholders from low-, middle-, and high-income countries. We anticipate that three rounds will allow an acceptable degree of agreement on research priorities. Discussion Our findings will advance understanding of how to meaningfully and equitably involve patients and the public in scaling-up initiatives for sustainable HSS. Systematic review registration We registered this protocol with the Open Science Framework on August 19, 2020 (https://osf.io/zqpx7/).

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The Unanticipated Challenges Associated With Implementing an Observational Study Protocol in a Large-Scale Physical Activity and Global Positioning System Data Collection

JMIR Research Protocols ◽

10.2196/resprot.9537 ◽

2018 ◽

Vol 7 (4) ◽

pp. e110

Author(s):

Paul McCrorie ◽

David Walker ◽

Anne Ellaway

Keyword(s):

Physical Activity ◽

Data Collection ◽

Observational Study ◽

Global Positioning System ◽

Study Protocol ◽

Large Scale ◽

Positioning System ◽

Global Positioning ◽

System Data

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A Delphi study to establish a consensus definition and clinical reporting guidelines for Mesenchymal Stromal Cells.

10.1101/2021.06.18.21259151 ◽

2021 ◽

Author(s):

Laurent Renesme ◽

Kelly D Cobey ◽

Maxime Le ◽

Manoj M Lalu ◽

Bernard Thebaud

Keyword(s):

Knowledge Translation ◽

Scoping Review ◽

Delphi Study ◽

Clinical Studies ◽

Reporting Guidelines ◽

Research Network ◽

Dissemination And Implementation ◽

Consensus Definition ◽

Core Group ◽

Modified Delphi

Introduction. Despite being more than two decades of research, Mesenchymal Stromal Cell (MSC) treatments are still struggling to cross the translational gap. Two key issues that likely contribute to these failures are i) the lack of clear definition for MSC and ii) poor quality of reporting in MSC clinical studies. To address these issues, we propose a modified Delphi study to establish a consensus definition for MSC and clinical reporting guidelines for MSC. Methods and analysis. We will conduct a three-round international modified Delphi Survey. Findings from a recent scoping review examining how MSC are defined and reported in preclinical and clinical studies were used to draft the initial survey for round one of our Delphi. Participants will include a "core group" of individuals as well as researchers whose work was captured in our scoping review. The core group will include stakeholders from different research fields including developmental biology, translational science, research methods, regulatory practices, scholarly journal editing, and industry. The first two survey rounds will be online, and the final round will take place in person. Each participant will be asked to rate their agreement on potential MSC definition characteristics and reporting items using a Likert scale. After each round, we will analyse data to determine which items have reached consensus for inclusion/exclusion, and then develop a revised questionnaire for any new items, or items that did not reach consensus. Ethics and dissemination. This study received ethical approval from the Ottawa Health Research Network Research Ethics Board. To support the dissemination of our findings, we will use an evidence-based "integrated knowledge translation" approach to engage knowledge users from the inception of the research. This will allow us to develop a tailored end-of-project knowledge translation plan to support and ensure dissemination and implementation of the Delphi results.

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ESPACOMP Medication Adherence Reporting Guidelines (EMERGE): a reactive-Delphi study protocol

BMJ Open ◽

10.1136/bmjopen-2016-013496 ◽

2017 ◽

Vol 7 (2) ◽

pp. e013496 ◽

Cited By ~ 16

Author(s):

R Helmy ◽

L L Zullig ◽

J Dunbar-Jacob ◽

D A Hughes ◽

B Vrijens ◽

...

Keyword(s):

Medication Adherence ◽

Study Protocol ◽

Delphi Study ◽

Reporting Guidelines

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Strategies for involving patients and the public in scaling-up initiatives in health and social services: study protocol for a scoping review and Delphi survey

10.21203/rs.3.rs-63534/v2 ◽

2021 ◽

Author(s):

Ali Ben Charif ◽

Karine V. Plourde ◽

Sabrina Guay-Belanger ◽

Hervé Tchala Vignon Zomahoun ◽

Amédé Gogovor ◽

...

Keyword(s):

Social Services ◽

Scoping Review ◽

Delphi Study ◽

Public Involvement ◽

Scale Up ◽

Scaling Up ◽

Delphi Survey ◽

The Public ◽

Health And Social Services ◽

Scoping Reviews

Abstract Background: The scale-up of evidence-based innovations is required to reduce waste and inequities in health and social services (HSS). However, it often tends to be a top-down process initiated by policy-makers, and the values of the intended beneficiaries are forgotten. Involving multiple stakeholders including patients and the public in the scaling-up process is thus essential but highly complex. We propose to identify relevant strategies for meaningfully and equitably involving patients and the public in the science and practice of scaling up in HSS.Methods: We will adapt our overall method from the RAND/UCLA Appropriateness Method. Following this, we will perform a two-prong study design (knowledge synthesis and Delphi study) grounded in an integrated knowledge translation approach. This approach involves extensive participation of a network of stakeholders interested in patient and public involvement (PPI) in scaling up and a multidisciplinary steering committee. We will conduct a systematic scoping review following the methodology recommended in the Joanna Briggs Institute Reviewers Manual. We will use the following eligibility criteria: 1) Participants – any stakeholder involved in creating or testing a strategy for PPI; 2) Intervention – any PPI strategy proposed for scaling-up initiatives; 3) Comparator – no restriction; 4) Outcomes: any process or outcome metrics related to PPI; and 5) Setting – HSS. We will search electronic databases (e.g., Medline, Web of Science, Sociological Abstract) from inception onwards, hand searching relevant websites, screen the reference lists of included records, and consult experts in the field. Two reviewers will independently select and extract eligible studies. We will summarize data quantitatively and qualitatively and report results using the PRISMA extension for Scoping Reviews (PRISMA-ScR) checklist. We will conduct an online Delphi survey to achieve consensus on the relevant strategies for PPI in scaling-up initiatives in HSS. Participants will include stakeholders from low-, middle-, and high-income countries. We anticipate that three rounds will allow an acceptable degree of agreement on research priorities. Discussion: Our findings will advance understanding of how to meaningfully and equitably involve patients and the public in scaling-up initiatives for sustainable HSS.Registration: We registered this protocol with the Open Science Framework on August 19, 2020 (https://osf.io/zqpx7/).

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Establishment of a consensus definition for mesenchymal stromal cells (MSC) and reporting guidelines for clinical trials of MSC therapy: a modified Delphi study protocol

BMJ Open ◽

10.1136/bmjopen-2021-054740 ◽

2021 ◽

Vol 11 (10) ◽

pp. e054740

Author(s):

Laurent Renesme ◽

Kelly D Cobey ◽

Maxime Le ◽

Manoj M Lalu ◽

Bernard Thebaud

Keyword(s):

Clinical Trials ◽

Knowledge Translation ◽

Scoping Review ◽

Delphi Study ◽

Clinical Studies ◽

Reporting Guidelines ◽

Research Network ◽

Consensus Definition ◽

Core Group ◽

Modified Delphi

IntroductionDespite being more than two decades of research, mesenchymal stromal cell (MSC) treatments are still struggling to cross the translational gap. Two key issues that likely contribute to these failures are (1) the lack of clear definition for MSC and (2) poor quality of reporting in MSC clinical studies. To address these issues, we propose a modified Delphi study to establish a consensus definition for MSC and reporting guidelines for clinical trials of MSC therapy.Methods and analysisWe will conduct a three-round international modified Delphi survey. Findings from a recent scoping review examining how MSCs are defined and reported in preclinical and clinical studies were used to draft the initial survey for round 1 of our Delphi. Participants will include a ‘core group’ of individuals as well as researchers whose work was captured in our scoping review. The core group will include stakeholders from different research fields including developmental biology, translational science, research methods, regulatory practices, scholarly journal editing and industry. The first two survey rounds will be online, and the final round will take place in person. Each participant will be asked to rate their agreement on potential MSC definition characteristics and reporting items using a Likert scale. After each round, we will analyse the data to determine which items have reached consensus for inclusion/exclusion, and then develop a revised questionnaire for any new items, or items that did not reach consensus.Ethics and disseminationThis study received ethical approval from the Ottawa Health Research Network Research Ethics Board. To support the dissemination of our findings, we will use an evidence-based ‘integrated knowledge translation’ approach to engage knowledge users from the inception of the research. This will allow us to develop a tailored end-of-project knowledge translation plan to support and ensure dissemination and implementation of the Delphi results.

Download Full-text