Spirit 2013 statement: Defining standard protocol items for clinical trials
01 Jan 2013-Chinese Journal of Evidence-Based Medicine (West China University of Medical Sciences)-Vol. 13, Iss: 12, pp 1501-1507
TL;DR: The systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 is described, a guideline for the minimum content of a clinical trial protocol.
Abstract: The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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TL;DR: Three main actions are warranted: academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets, and standards for the content of protocols and full study reports should be rigorously developed and adopted for all types of health research.
668 citations
01 Jan 2017
TL;DR: The development of the CONSORT PRO extension is described, based on the methodological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network, to supplement the standard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes.
543 citations
Cites methods from "Spirit 2013 statement: Defining sta..."
...Trialists should consider PRO-specific protocol requirements in relation to the FDA guidance and more general recommendations on RCT design from the Standard protocol Items: Recommendations for Interventional Trials (SPIRIT) initiative.(40,41)...
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University of Birmingham1, University of Sydney2, University of Toronto3, Medicines and Healthcare Products Regulatory Agency4, University of Washington5, University of Oxford6, University of North Carolina at Chapel Hill7, University of Leeds8, University of Warwick9, University of Bristol10, Johnson & Johnson11, Merck & Co.12, Food and Drug Administration13, Patient-Centered Outcomes Research Institute14, Queen's University15, National Cancer Research Institute16
TL;DR: The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome and improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.
Abstract: Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. Objective To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). Design, Setting, and Participants The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network’s methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. Results The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. Conclusions and Relevance The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.
445 citations
Cites background or methods from "Spirit 2013 statement: Defining sta..."
...Survey participants were asked to rate the importance of including each of the 56 candidate items in the final SPIRIT-PRO Extension using a 9-point scale ranging from not important (1-3) to important but not critical (4-6) and critical (7-9)....
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...Explanation: There are 2 levels of missing PRO data: (1) patient completion of some but not all items within an instrument and (2) absence of the entire PRO assessment....
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...to (1) include the candidate item as recommended; (2) exclude the item; (3) or initiate further discussion....
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...This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017)....
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TL;DR: Real‐world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials.
378 citations
TL;DR: There is no one-size-fits-all approach to addressing loneliness or social isolation, and hence the need to tailor interventions to suit the needs of individuals, specific groups or the degree of loneliness experienced.
Abstract: Loneliness and social isolation are growing public health concerns in our ageing society. Whilst these experiences occur across the life span, 50% of individuals aged over 60 are at risk of social isolation and one-third will experience some degree of loneliness later in life. The aim of this scoping review was to describe the range of interventions to reduce loneliness and social isolation among older adults that have been evaluated; in terms of intervention conceptualisation, categorisation, and components. Three electronic databases (CINAHL, Embase and Medline) were systematically searched for relevant published reviews of interventions for loneliness and social isolation. Inclusion criteria were: review of any type, published in English, a target population of older people and reported data on the categorisation of loneliness and/or social isolation interventions. Data extracted included: categories of interventions and the reasoning underpinning this categorisation. The methodology framework proposed by Arskey and O’Malley and further developed by Levac, et al. was used to guide the scoping review process. A total of 33 reviews met the inclusion criteria, evaluating a range of interventions targeted at older people residing in the community or institutionalised settings. Authors of reviews included in this paper often used the same terms to categorise different intervention components and many did not provide a clear definition of these terms. There were inconsistent meanings attributed to intervention characteristics. Overall, interventions were commonly categorised on the basis of: 1) group or one-to-one delivery mode, 2) the goal of the intervention, and 3) the intervention type. Several authors replicated the categorisation system used in previous reviews. Many interventions have been developed to combat loneliness and social isolation among older people. The individuality of the experience of loneliness and isolation may cause difficulty in the delivery of standardised interventions. There is no one-size-fits-all approach to addressing loneliness or social isolation, and hence the need to tailor interventions to suit the needs of individuals, specific groups or the degree of loneliness experienced. Therefore, future research should be aimed at discerning what intervention works for whom, in what particular context and how.
314 citations
Cites methods from "Spirit 2013 statement: Defining sta..."
...[73] was developed as an extension of the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement [74] and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement [75]....
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References
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TL;DR: The CONSORT (Consolidated Standards of Reporting Trials) statement as discussed by the authors is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.
Abstract: The CONSORT (Consolidated Standards of Reporting Trials) statement is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.
3,352 citations
TL;DR: The SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations and strongly recommends that this explanatory paper be used in conjunction with the SPIRit Statement.
Abstract: High quality protocols facilitate proper conduct, reporting, and external review
of clinical trials. However, the completeness of trial protocols is often
inadequate. To help improve the content and quality of protocols, an
international group of stakeholders developed the SPIRIT 2013 Statement
(Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT
Statement provides guidance in the form of a checklist of recommended items to
include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important
information to promote full understanding of the checklist recommendations. For
each checklist item, we provide a rationale and detailed description; a model
example from an actual protocol; and relevant references supporting its
importance. We strongly recommend that this explanatory paper be used in
conjunction with the SPIRIT Statement. A website of resources is also available
(www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement,
should help with the drafting of trial protocols. Complete documentation of key
trial elements can facilitate transparency and protocol review for the benefit
of all stakeholders.
3,108 citations
TL;DR: The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols and Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention.
Abstract: ContextSelective reporting of outcomes within published studies based on the
nature or direction of their results has been widely suspected, but direct
evidence of such bias is currently limited to case reports.ObjectiveTo study empirically the extent and nature of outcome reporting bias
in a cohort of randomized trials.DesignCohort study using protocols and published reports of randomized trials
approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg,
Denmark, in 1994-1995. The number and characteristics of reported and unreported
trial outcomes were recorded from protocols, journal articles, and a survey
of trialists. An outcome was considered incompletely reported if insufficient
data were presented in the published articles for meta-analysis. Odds ratios
relating the completeness of outcome reporting to statistical significance
were calculated for each trial and then pooled to provide an overall estimate
of bias. Protocols and published articles were also compared to identify discrepancies
in primary outcomes.Main Outcome MeasuresCompleteness of reporting of efficacy and harm outcomes and of statistically
significant vs nonsignificant outcomes; consistency between primary outcomes
defined in the most recent protocols and those defined in published articles.ResultsOne hundred two trials with 122 published journal articles and 3736
outcomes were identified. Overall, 50% of efficacy and 65% of harm outcomes
per trial were incompletely reported. Statistically significant outcomes had
a higher odds of being fully reported compared with nonsignificant outcomes
for both efficacy (pooled odds ratio, 2.4; 95% confidence interval [CI], 1.4-4.0)
and harm (pooled odds ratio, 4.7; 95% CI, 1.8-12.0) data. In comparing published
articles with protocols, 62% of trials had at least 1 primary outcome that
was changed, introduced, or omitted. Eighty-six percent of survey responders
(42/49) denied the existence of unreported outcomes despite clear evidence
to the contrary.ConclusionsThe reporting of trial outcomes is not only frequently incomplete but
also biased and inconsistent with protocols. Published articles, as well as
reviews that incorporate them, may therefore be unreliable and overestimate
the benefits of an intervention. To ensure transparency, planned trials should
be registered and protocols should be made publicly available prior to trial
completion.
1,638 citations
"Spirit 2013 statement: Defining sta..." refers background in this paper
...Many protocols for randomized trials do not adequately describe the primary outcomes (inadequate for 25% of trials) (18, 19), treatment allocation methods (inadequate for 54% to 79%) (20, 21), use of blinding (inadequate for 9% to 34%) (21, 22), methods for reporting adverse events (inadequate for 41%) (23), components of sample size calculations (inadequate for 4% to 40%) (21, 24), data analysis plans (inadequate for 20% to 77%) (21, 24–26), publication policies (inadequate for 7%) (27), and roles of sponsors and investigators in study design or data access (inadequate for 89% to 100%) (28, 29)....
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TL;DR: There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported.
Abstract: Background
The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias has been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Until recently, outcome reporting bias has received less attention.
1,373 citations
"Spirit 2013 statement: Defining sta..." refers result in this paper
...As a transparent record of the researchers’ original intent, comparisons of protocols with final trial reports can help to identify selective reporting of results and undisclosed amendments (48), such as changes to primary outcomes (19, 49)....
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TL;DR: David Moher and colleagues from the EQUATOR network offer guidance and recommended steps for developing health research reporting guidelines.
Abstract: David Moher and colleagues from the EQUATOR network offer guidance and recommended steps for developing health research reporting guidelines.
845 citations
"Spirit 2013 statement: Defining sta..." refers methods in this paper
...As detailed later, the SPIRIT guideline was developed through 2 systematic reviews, a formal Delphi consensus process, 2 face-to-face consensus meetings, and pilottesting (32)....
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