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      TIDieR-PHP: a reporting guideline for population health and policy interventions

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          Abstract

          We lack guidance on how to describe population health and policy (PHP) interventions in reports of evaluation studies. PHP interventions are legal, fiscal, structural, organisational, environmental, and policy interventions such as the regulation of unhealthy commodities, health service reorganisation, changes in welfare policy, and neighbourhood improvement schemes. Many PHP interventions have characteristics that are important for their implementation and success but are not adequately captured in the original Template for Intervention Description and Replication (TIDieR) checklist. This article describes the development of a revised reporting template for PHP interventions (TIDieR-PHP) and presents the checklist with examples for each item

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          The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

          Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
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            Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework

            Background The effectiveness of complex interventions, as well as their success in reaching relevant populations, is critically influenced by their implementation in a given context. Current conceptual frameworks often fail to address context and implementation in an integrated way and, where addressed, they tend to focus on organisational context and are mostly concerned with specific health fields. Our objective was to develop a framework to facilitate the structured and comprehensive conceptualisation and assessment of context and implementation of complex interventions. Methods The Context and Implementation of Complex Interventions (CICI) framework was developed in an iterative manner and underwent extensive application. An initial framework based on a scoping review was tested in rapid assessments, revealing inconsistencies with respect to the underlying concepts. Thus, pragmatic utility concept analysis was undertaken to advance the concepts of context and implementation. Based on these findings, the framework was revised and applied in several systematic reviews, one health technology assessment (HTA) and one applicability assessment of very different complex interventions. Lessons learnt from these applications and from peer review were incorporated, resulting in the CICI framework. Results The CICI framework comprises three dimensions—context, implementation and setting—which interact with one another and with the intervention dimension. Context comprises seven domains (i.e., geographical, epidemiological, socio-cultural, socio-economic, ethical, legal, political); implementation consists of five domains (i.e., implementation theory, process, strategies, agents and outcomes); setting refers to the specific physical location, in which the intervention is put into practise. The intervention and the way it is implemented in a given setting and context can occur on a micro, meso and macro level. Tools to operationalise the framework comprise a checklist, data extraction tools for qualitative and quantitative reviews and a consultation guide for applicability assessments. Conclusions The CICI framework addresses and graphically presents context, implementation and setting in an integrated way. It aims at simplifying and structuring complexity in order to advance our understanding of whether and how interventions work. The framework can be applied in systematic reviews and HTA as well as primary research and facilitate communication among teams of researchers and with various stakeholders. Electronic supplementary material The online version of this article (doi:10.1186/s13012-017-0552-5) contains supplementary material, which is available to authorized users.
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              Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2)

              Background Many healthcare interventions are of complex nature, consisting of several interacting components. Complex interventions are often described inadequately. A reporting guideline for complex interventions was published in 2012 (Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare, CReDECI) and was recently checked for its practicability. The reporting guideline was developed following the recommendations of the EQUATOR network but excluding a formal consensus process. Therefore, a consensus process was initiated, to revise the reporting guideline. Methods We used a three-phase consensus process consisting of (1) a web-based feedback survey on the published reporting guideline, (2) a face-to-face consensus conference, and (3) a final online review and feedback round to create the revised CReDECI. The consensus process was organized and conducted via the REFLECTION network. Results A total of 45 attendees from 16 European countries took part in the face-to-face consensus conference. The revised reporting guideline (CReDECI 2) comprises 13 items on three stages: development, feasibility and piloting, and evaluation of a complex intervention. Each item is illustrated by an explanation and an example. In contrast with most of the available reporting guidelines, CReDECI 2 does not focus on a specific study design, to reflect the use of different qualitative and quantitative designs and methods in the development and evaluation of complex interventions. Conclusions CReDECI 2 is a formally consented reporting guideline aiming to improve the reporting quality of the development and evaluation stages of complex interventions in healthcare. Since the guideline does not focus on a specific study design, design-specific reporting guidelines may additionally be used. Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-0709-y) contains supplementary material, which is available to authorized users.
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                Author and article information

                Contributors
                Role: research associate
                Role: clinical senior research fellow
                Role: professor of clinical epidemiology
                Role: associate research director
                Role: research director
                Role: senior research fellow
                Journal
                BMJ
                BMJ
                BMJ-UK
                bmj
                The BMJ
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2018
                16 May 2018
                : 361
                : k1079
                Affiliations
                [1 ]MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, 200 Renfield Street, Glasgow G2 3QB, UK
                Centre for Research in Evidence-Based Practice, Bond University, Queensland, Australia Melbourne School of Population and Global Health, University of Melbourne, VIC, Australia
                [* ]Deceased 22 September 2015
                Author notes
                Correspondence to: M Campbell mhairi.campbell@ 123456glasgow.ac.uk
                Article
                camm041840
                10.1136/bmj.k1079
                5954974
                29769210
                ba903e73-f863-4f14-90e0-471d3d19d374
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

                History
                : 21 February 2018
                Categories
                Research Methods & Reporting

                Medicine
                Medicine

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