It does not, however, provide specific guidance on protocol content relating to patient-reported outcomes (PROs), such as health-related quality of life or patient-reported symptoms.
#BASIC SURGICAL INSTRUMENTS QUIZ TRIAL#
1, 2 SPIRIT provides an evidence-based list of items recommended for inclusion in trial protocols. 1, 2 Quiz Ref ID To address this issue, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013. 1, 2 Although trial protocols serve as the foundation for study planning, conduct, reporting, and appraisal, they vary greatly in content and quality. A protocol should provide sufficient detail to enable funders, reviewers, and ethics committees to appraise the scientific, methodological, and ethical rigor of the trial and for the research team to conduct a high-quality study. Quiz Ref ID Clinical trial protocols are essential documents that describe the study design and conduct. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.
#BASIC SURGICAL INSTRUMENTS QUIZ PRO#
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.Ĭonclusions 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. 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.
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. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. Results The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. 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. 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). Objective To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension).ĭesign, 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. 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. 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.
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