- Record: found
- Abstract: found
- Article: found
eHealth for maintenance cardiovascular rehabilitation: a systematic review and meta-analysis
Author(s):
Melina Heimer ,
Sandra Schmitz ,
Marc Teschler ,
Hendrik Schäfer ,
Emma R Douma ,
Mirela Habibovic ,
Willem J Kop ,
Thorsten Meyer ,
Frank C Mooren ,
Boris Schmitz
Publication date Created:
May 08 2023
Publication date (Electronic):
May 08 2023
Publisher:
Oxford University Press (OUP)
Read this article at
There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.
Abstract
Aims
To provide a quantitative analysis of eHealth-supported interventions on health outcomes in cardiovascular rehabilitation (CR) maintenance (phase III) in patients with coronary artery disease (CAD) and to identify effective behavioural change techniques (BCTs).
Methods and results
A systematic review was conducted (PubMed, CINAHL, MEDLINE, and Web of Science) to summarize and synthesize the effects of eHealth in phase III maintenance on health outcomes including physical activity (PA) and exercise capacity, quality of life (QoL), mental health, self-efficacy, clinical variables, and events/rehospitalization. A meta-analysis following the Cochrane Collaboration guidelines using Review Manager (RevMan5.4) was performed. Analyses were conducted differentiating between short-term (≤6 months) and medium/long-term effects (>6 months). Effective behavioural change techniques were defined based on the described intervention and coded according to the BCT handbook. Fourteen eligible studies (1497 patients) were included. eHealth significantly promoted PA (SMD = 0.35; 95%CI 0.02–0.70; P = 0.04) and exercise capacity after 6 months (SMD = 0.29; 95%CI 0.05–0.52; P = 0.02) compared with usual care. Quality of life was higher with eHealth compared with care as usual (SMD = 0.17; 95%CI 0.02–0.32; P = 0.02). Systolic blood pressure decreased after 6 months with eHealth compared with care as usual (SMD = −0.20; 95%CI −0.40–0.00; P = 0.046). There was substantial heterogeneity in the adapted BCTs and type of intervention. Mapping of BCTs revealed that self-monitoring of behaviour and/or goal setting as well as feedback on behaviour were most frequently included.
Conclusion
eHealth in phase III CR is effective in stimulating PA and improving exercise capacity in patients with CAD while increasing QoL and decreasing systolic blood pressure. Currently, data of eHealth effects on morbidity, mortality, and clinical outcomes are scarce and should be investigated in future studies.
Related collections
Most cited references85
- Record: found
- Abstract: found
- Article: not found
Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement
David Moher, Alessandro Liberati, Jennifer Tetzlaff … (2012)
Systematic reviews and meta-analyses have become increasingly important in health care. Clinicians read them to keep up to date with their field,1,2 and they are often used as a starting point for developing clinical practice guidelines. Granting agencies may require a systematic review to ensure there is justification for further research,3 and some health care journals are moving in this direction.4 As with all research, the value of a systematic review depends on what was done, what was found, and the clarity of reporting. As with other publications, the reporting quality of systematic reviews varies, limiting readers' ability to assess the strengths and weaknesses of those reviews. Several early studies evaluated the quality of review reports. In 1987, Mulrow examined 50 review articles published in 4 leading medical journals in 1985 and 1986 and found that none met all 8 explicit scientific criteria, such as a quality assessment of included studies.5 In 1987, Sacks and colleagues6 evaluated the adequacy of reporting of 83 meta-analyses on 23 characteristics in 6 domains. Reporting was generally poor; between 1 and 14 characteristics were adequately reported (mean = 7.7; standard deviation = 2.7). A 1996 update of this study found little improvement.7 In 1996, to address the suboptimal reporting of meta-analyses, an international group developed a guidance called the QUOROM Statement (QUality Of Reporting Of Meta-analyses), which focused on the reporting of meta-analyses of randomized controlled trials.8 In this article, we summarize a revision of these guidelines, renamed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses), which have been updated to address several conceptual and practical advances in the science of systematic reviews (Box 1). Terminology The terminology used to describe a systematic review and meta-analysis has evolved over time. One reason for changing the name from QUOROM to PRISMA was the desire to encompass both systematic reviews and meta-analyses. We have adopted the definitions used by the Cochrane Collaboration.9 A systematic review is a review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyze and summarize the results of the included studies. Meta-analysis refers to the use of statistical techniques in a systematic review to integrate the results of included studies. Developing the PRISMA Statement A 3-day meeting was held in Ottawa, Canada, in June 2005 with 29 participants, including review authors, methodologists, clinicians, medical editors, and a consumer. The objective of the Ottawa meeting was to revise and expand the QUOROM checklist and flow diagram, as needed. The executive committee completed the following tasks, prior to the meeting: a systematic review of studies examining the quality of reporting of systematic reviews, and a comprehensive literature search to identify methodological and other articles that might inform the meeting, especially in relation to modifying checklist items. An international survey of review authors, consumers, and groups commissioning or using systematic reviews and meta-analyses was completed, including the International Network of Agencies for Health Technology Assessment (INAHTA) and the Guidelines International Network (GIN). The survey aimed to ascertain views of QUOROM, including the merits of the existing checklist items. The results of these activities were presented during the meeting and are summarized on the PRISMA Website. Only items deemed essential were retained or added to the checklist. Some additional items are nevertheless desirable, and review authors should include these, if relevant.10 For example, it is useful to indicate whether the systematic review is an update11 of a previous review, and to describe any changes in procedures from those described in the original protocol. Shortly after the meeting a draft of the PRISMA checklist was circulated to the group, including those invited to the meeting but unable to attend. A disposition file was created containing comments and revisions from each respondent, and the checklist was subsequently revised 11 times. The group approved the checklist, flow diagram, and this summary paper. Although no direct evidence was found to support retaining or adding some items, evidence from other domains was believed to be relevant. For example, Item 5 asks authors to provide registration information about the systematic review, including a registration number, if available. Although systematic review registration is not yet widely available,12,13 the participating journals of the International Committee of Medical Journal Editors (ICMJE)14 now require all clinical trials to be registered in an effort to increase transparency and accountability.15 Those aspects are also likely to benefit systematic reviewers, possibly reducing the risk of an excessive number of reviews addressing the same question16,17 and providing greater transparency when updating systematic reviews. The PRISMA Statement The PRISMA Statement consists of a 27-item checklist (Table 1; see also Text S1 for a downloadable template for researchers to re-use) and a 4-phase flow diagram (Figure 1; see also Figure S1 for a downloadable template for researchers to re-use). The aim of the PRISMA Statement is to help authors improve the reporting of systematic reviews and meta-analyses. We have focused on randomized trials, but PRISMA can also be used as a basis for reporting systematic reviews of other types of research, particularly evaluations of interventions. PRISMA may also be useful for critical appraisal of published systematic reviews. However, the PRISMA checklist is not a quality assessment instrument to gauge the quality of a systematic review. Box 1 Conceptual issues in the evolution from QUOROM to PRISMA Figure 1 Flow of information through the different phases of a systematic review Table 1 Checklist of items to include when reporting a systematic review or meta-analysis From QUOROM to PRISMA The new PRISMA checklist differs in several respects from the QUOROM checklist, and the substantive specific changes are highlighted in Table 2. Generally, the PRISMA checklist “decouples” several items present in the QUOROM checklist and, where applicable, several checklist items are linked to improve consistency across the systematic review report. Table 2 Substantive specific changes between the QUOROM checklist and the PRISMA checklist (a tick indicates the presence of the topic in QUOROM or PRISMA) The flow diagram has also been modified. Before including studies and providing reasons for excluding others, the review team must first search the literature. This search results in records. Once these records have been screened and eligibility criteria applied, a smaller number of articles will remain. The number of included articles might be smaller (or larger) than the number of studies, because articles may report on multiple studies and results from a particular study may be published in several articles. To capture this information, the PRISMA flow diagram now requests information on these phases of the review process. Endorsement The PRISMA Statement should replace the QUOROM Statement for those journals that have endorsed QUOROM. We hope that other journals will support PRISMA; they can do so by registering on the PRISMA Website. To underscore to authors, and others, the importance of transparent reporting of systematic reviews, we encourage supporting journals to reference the PRISMA Statement and include the PRISMA web address in their Instructions to Authors. We also invite editorial organizations to consider endorsing PRISMA and encourage authors to adhere to its principles. The PRISMA Explanation and Elaboration Paper In addition to the PRISMA Statement, a supporting Explanation and Elaboration document has been produced18 following the style used for other reporting guidelines.19-21 The process of completing this document included developing a large database of exemplars to highlight how best to report each checklist item, and identifying a comprehensive evidence base to support the inclusion of each checklist item. The Explanation and Elaboration document was completed after several face-to-face meetings and numerous iterations among several meeting participants, after which it was shared with the whole group for additional revisions and final approval. Finally, the group formed a dissemination subcommittee to help disseminate and implement PRISMA. Discussion The quality of reporting of systematic reviews is still not optimal.22-27 In a recent review of 300 systematic reviews, few authors reported assessing possible publication bias,22 even though there is overwhelming evidence both for its existence28 and its impact on the results of systematic reviews.29 Even when the possibility of publication bias is assessed, there is no guarantee that systematic reviewers have assessed or interpreted it appropriately.30 Although the absence of reporting such an assessment does not necessarily indicate that it was not done, reporting an assessment of possible publication bias is likely to be a marker of the thoroughness of the conduct of the systematic review. Several approaches have been developed to conduct systematic reviews on a broader array of questions. For example, systematic reviews are now conducted to investigate cost-effectiveness,31 diagnostic32 or prognostic questions,33 genetic associations,34 and policy-making.35 The general concepts and topics covered by PRISMA are all relevant to any systematic review, not just those whose objective is to summarize the benefits and harms of a health care intervention. However, some modifications of the checklist items or flow diagram will be necessary in particular circumstances. For example, assessing the risk of bias is a key concept, but the items used to assess this in a diagnostic review are likely to focus on issues such as the spectrum of patients and the verification of disease status, which differ from reviews of interventions. The flow diagram will also need adjustments when reporting individual patient data meta-analysis.36 We have developed an explanatory document18 to increase the usefulness of PRISMA. For each checklist item, this document contains an example of good reporting, a rationale for its inclusion, and supporting evidence, including references, whenever possible. We believe this document will also serve as a useful resource for those teaching systematic review methodology. We encourage journals to include reference to the explanatory document in their Instructions to Authors. Like any evidence-based endeavour, PRISMA is a living document. To this end we invite readers to comment on the revised version, particularly the new checklist and flow diagram, through the PRISMA website. We will use such information to inform PRISMA's continued development. Note: To encourage dissemination of the PRISMA Statement, this article is freely accessible on the Open Medicine website and the PLoS Medicine website and is also published in the Annals of Internal Medicine, BMJ, and Journal of Clinical Epidemiology. The authors jointly hold the copyright of this article. For details on further use, see the PRISMA website. The PRISMA Explanation and Elaboration Paper is available at the PLoS Medicine website. Supporting Information Figure S1 Flow of information through the different phases of a systematic review (downloadable template document for researchers to re-use) Text S1 Checklist of items to include when reporting a systematic review or meta-analysis (downloadable template document for researchers to re-use)
- Record: found
- Abstract: found
- Article: found
The PRISMA 2020 statement: an updated guideline for reporting systematic reviews
The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews. In order to encourage its wide dissemination this article is freely accessible on BMJ, PLOS Medicine, Journal of Clinical Epidemiology and International Journal of Surgery journal websites. Systematic reviews serve many critical roles. They can provide syntheses of the state of knowledge in a field, from which future research priorities can be identified; they can address questions that otherwise could not be answered by individual studies; they can identify problems in primary research that should be rectified in future studies; and they can generate or evaluate theories about how or why phenomena occur. Systematic reviews therefore generate various types of knowledge for different users of reviews (such as patients, healthcare providers, researchers, and policy makers) [1, 2]. To ensure a systematic review is valuable to users, authors should prepare a transparent, complete, and accurate account of why the review was done, what they did (such as how studies were identified and selected) and what they found (such as characteristics of contributing studies and results of meta-analyses). Up-to-date reporting guidance facilitates authors achieving this [3]. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement published in 2009 (hereafter referred to as PRISMA 2009) [4–10] is a reporting guideline designed to address poor reporting of systematic reviews [11]. The PRISMA 2009 statement comprised a checklist of 27 items recommended for reporting in systematic reviews and an “explanation and elaboration” paper [12–16] providing additional reporting guidance for each item, along with exemplars of reporting. The recommendations have been widely endorsed and adopted, as evidenced by its co-publication in multiple journals, citation in over 60,000 reports (Scopus, August 2020), endorsement from almost 200 journals and systematic review organisations, and adoption in various disciplines. Evidence from observational studies suggests that use of the PRISMA 2009 statement is associated with more complete reporting of systematic reviews [17–20], although more could be done to improve adherence to the guideline [21]. Many innovations in the conduct of systematic reviews have occurred since publication of the PRISMA 2009 statement. For example, technological advances have enabled the use of natural language processing and machine learning to identify relevant evidence [22–24], methods have been proposed to synthesise and present findings when meta-analysis is not possible or appropriate [25–27], and new methods have been developed to assess the risk of bias in results of included studies [28, 29]. Evidence on sources of bias in systematic reviews has accrued, culminating in the development of new tools to appraise the conduct of systematic reviews [30, 31]. Terminology used to describe particular review processes has also evolved, as in the shift from assessing “quality” to assessing “certainty” in the body of evidence [32]. In addition, the publishing landscape has transformed, with multiple avenues now available for registering and disseminating systematic review protocols [33, 34], disseminating reports of systematic reviews, and sharing data and materials, such as preprint servers and publicly accessible repositories. To capture these advances in the reporting of systematic reviews necessitated an update to the PRISMA 2009 statement. Summary points • To ensure a systematic review is valuable to users, authors should prepare a transparent, complete, and accurate account of why the review was done, what they did, and what they found • The PRISMA 2020 statement provides updated reporting guidance for systematic reviews that reflects advances in methods to identify, select, appraise, and synthesise studies • The PRISMA 2020 statement consists of a 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and revised flow diagrams for original and updated reviews • We anticipate that the PRISMA 2020 statement will benefit authors, editors, and peer reviewers of systematic reviews, and different users of reviews, including guideline developers, policy makers, healthcare providers, patients, and other stakeholders Development of PRISMA 2020 A complete description of the methods used to develop PRISMA 2020 is available elsewhere [35]. We identified PRISMA 2009 items that were often reported incompletely by examining the results of studies investigating the transparency of reporting of published reviews [17, 21, 36, 37]. We identified possible modifications to the PRISMA 2009 statement by reviewing 60 documents providing reporting guidance for systematic reviews (including reporting guidelines, handbooks, tools, and meta-research studies) [38]. These reviews of the literature were used to inform the content of a survey with suggested possible modifications to the 27 items in PRISMA 2009 and possible additional items. Respondents were asked whether they believed we should keep each PRISMA 2009 item as is, modify it, or remove it, and whether we should add each additional item. Systematic review methodologists and journal editors were invited to complete the online survey (110 of 220 invited responded). We discussed proposed content and wording of the PRISMA 2020 statement, as informed by the review and survey results, at a 21-member, two-day, in-person meeting in September 2018 in Edinburgh, Scotland. Throughout 2019 and 2020, we circulated an initial draft and five revisions of the checklist and explanation and elaboration paper to co-authors for feedback. In April 2020, we invited 22 systematic reviewers who had expressed interest in providing feedback on the PRISMA 2020 checklist to share their views (via an online survey) on the layout and terminology used in a preliminary version of the checklist. Feedback was received from 15 individuals and considered by the first author, and any revisions deemed necessary were incorporated before the final version was approved and endorsed by all co-authors. The PRISMA 2020 statement Scope of the guideline The PRISMA 2020 statement has been designed primarily for systematic reviews of studies that evaluate the effects of health interventions, irrespective of the design of the included studies. However, the checklist items are applicable to reports of systematic reviews evaluating other interventions (such as social or educational interventions), and many items are applicable to systematic reviews with objectives other than evaluating interventions (such as evaluating aetiology, prevalence, or prognosis). PRISMA 2020 is intended for use in systematic reviews that include synthesis (such as pairwise meta-analysis or other statistical synthesis methods) or do not include synthesis (for example, because only one eligible study is identified). The PRISMA 2020 items are relevant for mixed-methods systematic reviews (which include quantitative and qualitative studies), but reporting guidelines addressing the presentation and synthesis of qualitative data should also be consulted [39, 40]. PRISMA 2020 can be used for original systematic reviews, updated systematic reviews, or continually updated (“living”) systematic reviews. However, for updated and living systematic reviews, there may be some additional considerations that need to be addressed. Where there is relevant content from other reporting guidelines, we reference these guidelines within the items in the explanation and elaboration paper [41] (such as PRISMA-Search [42] in items 6 and 7, Synthesis without meta-analysis (SWiM) reporting guideline [27] in item 13d). Box 1 includes a glossary of terms used throughout the PRISMA 2020 statement. PRISMA 2020 is not intended to guide systematic review conduct, for which comprehensive resources are available [43–46]. However, familiarity with PRISMA 2020 is useful when planning and conducting systematic reviews to ensure that all recommended information is captured. PRISMA 2020 should not be used to assess the conduct or methodological quality of systematic reviews; other tools exist for this purpose [30, 31]. Furthermore, PRISMA 2020 is not intended to inform the reporting of systematic review protocols, for which a separate statement is available (PRISMA for Protocols (PRISMA-P) 2015 statement [47, 48]). Finally, extensions to the PRISMA 2009 statement have been developed to guide reporting of network meta-analyses [49], meta-analyses of individual participant data [50], systematic reviews of harms [51], systematic reviews of diagnostic test accuracy studies [52], and scoping reviews [53]; for these types of reviews we recommend authors report their review in accordance with the recommendations in PRISMA 2020 along with the guidance specific to the extension. How to use PRISMA 2020 The PRISMA 2020 statement (including the checklists, explanation and elaboration, and flow diagram) replaces the PRISMA 2009 statement, which should no longer be used. Box 2 summarises noteworthy changes from the PRISMA 2009 statement. The PRISMA 2020 checklist includes seven sections with 27 items, some of which include sub-items (Table 1). A checklist for journal and conference abstracts for systematic reviews is included in PRISMA 2020. This abstract checklist is an update of the 2013 PRISMA for Abstracts statement [54], reflecting new and modified content in PRISMA 2020 (Table 2). A template PRISMA flow diagram is provided, which can be modified depending on whether the systematic review is original or updated (Fig. 1). Table 1 PRISMA 2020 item checklist Section and topic Item # Checklist item Location where item is reported Title Title 1 Identify the report as a systematic review. Abstract Abstract 2 See the PRISMA 2020 for Abstracts checklist (Table 2). Introduction Rationale 3 Describe the rationale for the review in the context of existing knowledge. Objectives 4 Provide an explicit statement of the objective(s) or question(s) the review addresses. Methods Eligibility criteria 5 Specify the inclusion and exclusion criteria for the review and how studies were grouped for the syntheses. Information sources 6 Specify all databases, registers, websites, organisations, reference lists and other sources searched or consulted to identify studies. Specify the date when each source was last searched or consulted. Search strategy 7 Present the full search strategies for all databases, registers and websites, including any filters and limits used. Selection process 8 Specify the methods used to decide whether a study met the inclusion criteria of the review, including how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process. Data collection process 9 Specify the methods used to collect data from reports, including how many reviewers collected data from each report, whether they worked independently, any processes for obtaining or confirming data from study investigators, and if applicable, details of automation tools used in the process. Data items 10a List and define all outcomes for which data were sought. Specify whether all results that were compatible with each outcome domain in each study were sought (e.g. for all measures, time points, analyses), and if not, the methods used to decide which results to collect. 10b List and define all other variables for which data were sought (e.g. participant and intervention characteristics, funding sources). Describe any assumptions made about any missing or unclear information. Study risk of bias assessment 11 Specify the methods used to assess risk of bias in the included studies, including details of the tool(s) used, how many reviewers assessed each study and whether they worked independently, and if applicable, details of automation tools used in the process. Effect measures 12 Specify for each outcome the effect measure(s) (e.g. risk ratio, mean difference) used in the synthesis or presentation of results. Synthesis methods 13a Describe the processes used to decide which studies were eligible for each synthesis (e.g. tabulating the study intervention characteristics and comparing against the planned groups for each synthesis (item #5)). 13b Describe any methods required to prepare the data for presentation or synthesis, such as handling of missing summary statistics, or data conversions. 13c Describe any methods used to tabulate or visually display results of individual studies and syntheses. 13d Describe any methods used to synthesise results and provide a rationale for the choice(s). If meta-analysis was performed, describe the model(s), method(s) to identify the presence and extent of statistical heterogeneity, and software package(s) used. 13e Describe any methods used to explore possible causes of heterogeneity among study results (e.g. subgroup analysis, meta-regression). 13f Describe any sensitivity analyses conducted to assess robustness of the synthesised results. Reporting bias assessment 14 Describe any methods used to assess risk of bias due to missing results in a synthesis (arising from reporting biases). Certainty assessment 15 Describe any methods used to assess certainty (or confidence) in the body of evidence for an outcome. Results Study selection 16a Describe the results of the search and selection process, from the number of records identified in the search to the number of studies included in the review, ideally using a flow diagram (see Fig. 1). 16b Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded. Study characteristics 17 Cite each included study and present its characteristics. Risk of bias in studies 18 Present assessments of risk of bias for each included study. Results of individual studies 19 For all outcomes, present, for each study: (a) summary statistics for each group (where appropriate) and (b) an effect estimate and its precision (e.g. confidence/credible interval), ideally using structured tables or plots. Results of syntheses 20a For each synthesis, briefly summarise the characteristics and risk of bias among contributing studies. 20b Present results of all statistical syntheses conducted. If meta-analysis was done, present for each the summary estimate and its precision (e.g. confidence/credible interval) and measures of statistical heterogeneity. If comparing groups, describe the direction of the effect. 20c Present results of all investigations of possible causes of heterogeneity among study results. 20d Present results of all sensitivity analyses conducted to assess the robustness of the synthesised results. Reporting biases 21 Present assessments of risk of bias due to missing results (arising from reporting biases) for each synthesis assessed. Certainty of evidence 22 Present assessments of certainty (or confidence) in the body of evidence for each outcome assessed. Discussion Discussion 23a Provide a general interpretation of the results in the context of other evidence. 23b Discuss any limitations of the evidence included in the review. 23c Discuss any limitations of the review processes used. 23d Discuss implications of the results for practice, policy, and future research. Other information Registration and protocol 24a Provide registration information for the review, including register name and registration number, or state that the review was not registered. 24b Indicate where the review protocol can be accessed, or state that a protocol was not prepared. 24c Describe and explain any amendments to information provided at registration or in the protocol. Support 25 Describe sources of financial or non-financial support for the review, and the role of the funders or sponsors in the review. Competing interests 26 Declare any competing interests of review authors. Availability of data, code, and other materials 27 Report which of the following are publicly available and where they can be found: template data collection forms; data extracted from included studies; data used for all analyses; analytic code; any other materials used in the review. Table 2 PRISMA 2020 for abstracts checklista Section and topic Item # Checklist item Title Title 1 Identify the report as a systematic review. Background Objectives 2 Provide an explicit statement of the main objective(s) or question(s) the review addresses. Methods Eligibility criteria 3 Specify the inclusion and exclusion criteria for the review. Information sources 4 Specify the information sources (e.g. databases, registers) used to identify studies and the date when each was last searched. Risk of bias 5 Specify the methods used to assess risk of bias in the included studies. Synthesis of results 6 Specify the methods used to present and synthesise results. Results Included studies 7 Give the total number of included studies and participants and summarise relevant characteristics of studies. Synthesis of results 8 Present results for main outcomes, preferably indicating the number of included studies and participants for each. If meta-analysis was done, report the summary estimate and confidence/credible interval. If comparing groups, indicate the direction of the effect (i.e. which group is favoured). Discussion Limitations of evidence 9 Provide a brief summary of the limitations of the evidence included in the review (e.g. study risk of bias, inconsistency and imprecision). Interpretation 10 Provide a general interpretation of the results and important implications. Other Funding 11 Specify the primary source of funding for the review. Registration 12 Provide the register name and registration number. aThis abstract checklist retains the same items as those included in the PRISMA for Abstracts statement published in 2013 [54], but has been revised to make the wording consistent with the PRISMA 2020 statement and includes a new item recommending authors specify the methods used to present and synthesise results (item #6) Fig. 1 PRISMA 2020 flow diagram template for systematic reviews. The new design is adapted from flow diagrams proposed by Boers [55], Mayo-Wilson et al. [56] and Stovold et al. [57] The boxes in grey should only be completed if applicable; otherwise they should be removed from the flow diagram. Note that a “report” could be a journal article, preprint, conference abstract, study register entry, clinical study report, dissertation, unpublished manuscript, government report or any other document providing relevant information We recommend authors refer to PRISMA 2020 early in the writing process, because prospective consideration of the items may help to ensure that all the items are addressed. To help keep track of which items have been reported, the PRISMA statement website (http://www.prisma-statement.org/) includes fillable templates of the checklists to download and complete (also available in Additional file 1). We have also created a web application that allows users to complete the checklist via a user-friendly interface [58] (available at https://prisma.shinyapps.io/checklist/ and adapted from the Transparency Checklist app [59]). The completed checklist can be exported to Word or PDF. Editable templates of the flow diagram can also be downloaded from the PRISMA statement website. We have prepared an updated explanation and elaboration paper, in which we explain why reporting of each item is recommended and present bullet points that detail the reporting recommendations (which we refer to as elements) [41]. The bullet-point structure is new to PRISMA 2020 and has been adopted to facilitate implementation of the guidance [60, 61]. An expanded checklist, which comprises an abridged version of the elements presented in the explanation and elaboration paper, with references and some examples removed, is available in Additional file 2. Consulting the explanation and elaboration paper is recommended if further clarity or information is required. Journals and publishers might impose word and section limits, and limits on the number of tables and figures allowed in the main report. In such cases, if the relevant information for some items already appears in a publicly accessible review protocol, referring to the protocol may suffice. Alternatively, placing detailed descriptions of the methods used or additional results (such as for less critical outcomes) in supplementary files is recommended. Ideally, supplementary files should be deposited to a general-purpose or institutional open-access repository that provides free and permanent access to the material (such as Open Science Framework, Dryad, figshare). A reference or link to the additional information should be included in the main report. Finally, although PRISMA 2020 provides a template for where information might be located, the suggested location should not be seen as prescriptive; the guiding principle is to ensure the information is reported. Discussion Use of PRISMA 2020 has the potential to benefit many stakeholders. Complete reporting allows readers to assess the appropriateness of the methods, and therefore the trustworthiness of the findings. Presenting and summarising characteristics of studies contributing to a synthesis allows healthcare providers and policy makers to evaluate the applicability of the findings to their setting. Describing the certainty in the body of evidence for an outcome and the implications of findings should help policy makers, managers, and other decision makers formulate appropriate recommendations for practice or policy. Complete reporting of all PRISMA 2020 items also facilitates replication and review updates, as well as inclusion of systematic reviews in overviews (of systematic reviews) and guidelines, so teams can leverage work that is already done and decrease research waste [36, 62, 63]. We updated the PRISMA 2009 statement by adapting the EQUATOR Network’s guidance for developing health research reporting guidelines [64]. We evaluated the reporting completeness of published systematic reviews [17, 21, 36, 37], reviewed the items included in other documents providing guidance for systematic reviews [38], surveyed systematic review methodologists and journal editors for their views on how to revise the original PRISMA statement [35], discussed the findings at an in-person meeting, and prepared this document through an iterative process. Our recommendations are informed by the reviews and survey conducted before the in-person meeting, theoretical considerations about which items facilitate replication and help users assess the risk of bias and applicability of systematic reviews, and co-authors’ experience with authoring and using systematic reviews. Various strategies to increase the use of reporting guidelines and improve reporting have been proposed. They include educators introducing reporting guidelines into graduate curricula to promote good reporting habits of early career scientists [65]; journal editors and regulators endorsing use of reporting guidelines [18]; peer reviewers evaluating adherence to reporting guidelines [61, 66]; journals requiring authors to indicate where in their manuscript they have adhered to each reporting item [67]; and authors using online writing tools that prompt complete reporting at the writing stage [60]. Multi-pronged interventions, where more than one of these strategies are combined, may be more effective (such as completion of checklists coupled with editorial checks) [68]. However, of 31 interventions proposed to increase adherence to reporting guidelines, the effects of only 11 have been evaluated, mostly in observational studies at high risk of bias due to confounding [69]. It is therefore unclear which strategies should be used. Future research might explore barriers and facilitators to the use of PRISMA 2020 by authors, editors, and peer reviewers, designing interventions that address the identified barriers, and evaluating those interventions using randomised trials. To inform possible revisions to the guideline, it would also be valuable to conduct think-aloud studies [70] to understand how systematic reviewers interpret the items, and reliability studies to identify items where there is varied interpretation of the items. We encourage readers to submit evidence that informs any of the recommendations in PRISMA 2020 (via the PRISMA statement website: http://www.prisma-statement.org/). To enhance accessibility of PRISMA 2020, several translations of the guideline are under way (see available translations at the PRISMA statement website). We encourage journal editors and publishers to raise awareness of PRISMA 2020 (for example, by referring to it in journal “Instructions to authors”), endorsing its use, advising editors and peer reviewers to evaluate submitted systematic reviews against the PRISMA 2020 checklists, and making changes to journal policies to accommodate the new reporting recommendations. We recommend existing PRISMA extensions [47, 49–53, 71, 72] be updated to reflect PRISMA 2020 and advise developers of new PRISMA extensions to use PRISMA 2020 as the foundation document. Conclusion We anticipate that the PRISMA 2020 statement will benefit authors, editors, and peer reviewers of systematic reviews, and different users of reviews, including guideline developers, policy makers, healthcare providers, patients, and other stakeholders. Ultimately, we hope that uptake of the guideline will lead to more transparent, complete, and accurate reporting of systematic reviews, thus facilitating evidence based decision making. Box 1 Glossary of terms Systematic review—A review that uses explicit, systematic methods to collate and synthesise findings of studies that address a clearly formulated question [43] Statistical synthesis—The combination of quantitative results of two or more studies. This encompasses meta-analysis of effect estimates (described below) and other methods, such as combining P values, calculating the range and distribution of observed effects, and vote counting based on the direction of effect (see McKenzie and Brennan [25] for a description of each method) Meta-analysis of effect estimates—A statistical technique used to synthesise results when study effect estimates and their variances are available, yielding a quantitative summary of results [25] Outcome—An event or measurement collected for participants in a study (such as quality of life, mortality) Result—The combination of a point estimate (such as a mean difference, risk ratio, or proportion) and a measure of its precision (such as a confidence/credible interval) for a particular outcome Report—A document (paper or electronic) supplying information about a particular study. It could be a journal article, preprint, conference abstract, study register entry, clinical study report, dissertation, unpublished manuscript, government report, or any other document providing relevant information Record—The title or abstract (or both) of a report indexed in a database or website (such as a title or abstract for an article indexed in Medline). Records that refer to the same report (such as the same journal article) are “duplicates”; however, records that refer to reports that are merely similar (such as a similar abstract submitted to two different conferences) should be considered unique. Study—An investigation, such as a clinical trial, that includes a defined group of participants and one or more interventions and outcomes. A “study” might have multiple reports. For example, reports could include the protocol, statistical analysis plan, baseline characteristics, results for the primary outcome, results for harms, results for secondary outcomes, and results for additional mediator and moderator analyses Box 2 Noteworthy changes to the PRISMA 2009 statement • Inclusion of the abstract reporting checklist within PRISMA 2020 (see item #2 and Box 2). • Movement of the ‘Protocol and registration’ item from the start of the Methods section of the checklist to a new Other section, with addition of a sub-item recommending authors describe amendments to information provided at registration or in the protocol (see item #24a-24c). • Modification of the ‘Search’ item to recommend authors present full search strategies for all databases, registers and websites searched, not just at least one database (see item #7). • Modification of the ‘Study selection’ item in the Methods section to emphasise the reporting of how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process (see item #8). • Addition of a sub-item to the ‘Data items’ item recommending authors report how outcomes were defined, which results were sought, and methods for selecting a subset of results from included studies (see item #10a). • Splitting of the ‘Synthesis of results’ item in the Methods section into six sub-items recommending authors describe: the processes used to decide which studies were eligible for each synthesis; any methods required to prepare the data for synthesis; any methods used to tabulate or visually display results of individual studies and syntheses; any methods used to synthesise results; any methods used to explore possible causes of heterogeneity among study results (such as subgroup analysis, meta-regression); and any sensitivity analyses used to assess robustness of the synthesised results (see item #13a-13f). • Addition of a sub-item to the ‘Study selection’ item in the Results section recommending authors cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded (see item #16b). • Splitting of the ‘Synthesis of results’ item in the Results section into four sub-items recommending authors: briefly summarise the characteristics and risk of bias among studies contributing to the synthesis; present results of all statistical syntheses conducted; present results of any investigations of possible causes of heterogeneity among study results; and present results of any sensitivity analyses (see item #20a-20d). • Addition of new items recommending authors report methods for and results of an assessment of certainty (or confidence) in the body of evidence for an outcome (see items #15 and #22). • Addition of a new item recommending authors declare any competing interests (see item #26). • Addition of a new item recommending authors indicate whether data, analytic code and other materials used in the review are publicly available and if so, where they can be found (see item #27). Supplementary Information Additional file 1. PRISMA 2020 checklist. Additional file 2. PRISMA 2020 expanded checklist.
- Record: found
- Abstract: found
- Article: found
Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range
Xiang Wan, Wenqian Wang, Jiming Liu … (2014)
Background In systematic reviews and meta-analysis, researchers often pool the results of the sample mean and standard deviation from a set of similar clinical trials. A number of the trials, however, reported the study using the median, the minimum and maximum values, and/or the first and third quartiles. Hence, in order to combine results, one may have to estimate the sample mean and standard deviation for such trials. Methods In this paper, we propose to improve the existing literature in several directions. First, we show that the sample standard deviation estimation in Hozo et al.’s method (BMC Med Res Methodol 5:13, 2005) has some serious limitations and is always less satisfactory in practice. Inspired by this, we propose a new estimation method by incorporating the sample size. Second, we systematically study the sample mean and standard deviation estimation problem under several other interesting settings where the interquartile range is also available for the trials. Results We demonstrate the performance of the proposed methods through simulation studies for the three frequently encountered scenarios, respectively. For the first two scenarios, our method greatly improves existing methods and provides a nearly unbiased estimate of the true sample standard deviation for normal data and a slightly biased estimate for skewed data. For the third scenario, our method still performs very well for both normal data and skewed data. Furthermore, we compare the estimators of the sample mean and standard deviation under all three scenarios and present some suggestions on which scenario is preferred in real-world applications. Conclusions In this paper, we discuss different approximation methods in the estimation of the sample mean and standard deviation and propose some new estimation methods to improve the existing literature. We conclude our work with a summary table (an Excel spread sheet including all formulas) that serves as a comprehensive guidance for performing meta-analysis in different situations. Electronic supplementary material The online version of this article (doi:10.1186/1471-2288-14-135) contains supplementary material, which is available to authorized users.
Author and article information
Contributors
Melina Heimer:
(View ORCID Profile)
Thorsten Meyer:
(View ORCID Profile)
Journal
Title:
European Journal of Preventive Cardiology
Publisher:
Oxford University Press (OUP)
ISSN
(Print):
2047-4873
ISSN
(Electronic):
2047-4881
Publication date Created:
October
2023
Publication date Created:
October
26 2023
Publication date Created:
May
08 2023
Publication date Other:
October
2023
Publication date
(Print):
October
26 2023
Publication date
(Electronic):
May
08 2023
Volume: 30
Issue: 15
Pages: 1634-1651
Article
DOI: 10.1093/eurjpc/zwad145
PubMed ID: 37154363
SO-VID: e87743a7-6dbb-4f2d-90ed-f41a170eb17f
Copyright © ©
2023
History
Data availability:
Comments
Comment on this article
scite_
0
0
0
0
Smart Citations0
0
0
0
Citing PublicationsSupportingMentioningContrasting
See how this article has been cited at scite.ai
scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.