ReviewBMJ open2021
SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.
Review in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07250490 (Validation of the DIVAS-Q), which is not on this map. Cited by 68 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Validation of the DIVAS-Q (Day to Day Impact of Vulvovaginal Atrophic Symptoms Questionnaire) A Portuguese Patient-Reported Outcome Measure
Who cites it
68 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Pooled it
- Patient-report and caregiver-report measures of rehabilitation service use following acquired brain injury: a systematic review.BMJ open · 2024Pooled it
- Reporting quality of randomized controlled trials evaluating non-vitamin K oral anticoagulants in atrial fibrillation: a systematic review.BMC cardiovascular disorders · 2023Pooled it
- [Extensions of guidelines for reporting types of study in medicine].Revista medica del Instituto Mexicano del Seguro Social · 2022Pooled it
- Trial
- Impact of withholding early parenteral nutrition on 2-year mortality and functional outcome in critically ill adults.Intensive care medicine · 2024Trial
- Evaluation of the Distal Radial Approach in percutaneous coronary interventions. Controlled, randomized non-inferiority trial.La Tunisie medicaleTrial
- Electronic Patient-Reported Health-Related Quality of Life Trajectories in ICU Survivors: A Multicentre Pilot Study-Within-a-Trial Protocol.Acta anaesthesiologica Scandinavica · 2026Article
- Nurse-led care model to overcome migration-related language barriers in people with cancer (BMJ open · 2026Article
- Validation of the DIVAS-Q (Day-to-Day Impact of Vulvovaginal Atrophic Symptoms Questionnaire): a Portuguese patient-reported outcome measure.Journal of patient-reported outcomes · 2026Observational
- Article
- Patient-reported Outcome Measures in Solid Organ Transplant Recipients: Current use, Challenges, and Recommendations for Future use.Transplantation · 2026Review
- Core outcome sets and trials of nutrition and metabolism interventions.Current opinion in clinical nutrition and metabolic care · 2026Review
- Efficacy of a video-viewing intervention of smartphone-based positive word stimulation on depressive symptoms in individuals with subthreshold depression: Protocol for a randomized controlled trial.PCN reports : psychiatry and clinical neurosciences · 2026Article
- 1st Global Consensus for Clinical Guidelines: Identifying a Core Outcome Set for Implant Dentistry in Edentulous Maxilla Rehabilitation.Clinical oral implants research · 2026Article
- Review
- Article
- Application of patient-reported outcomes in clinical trials of traditional Chinese medicine registered in international clinical trials registry platform, from 2010 to 2022: a cross-sectional study.Journal of patient-reported outcomes · 2026Article
- Perspective on patient and non-academic partner engagement for the responsible integration of large language models in health chatbots.Research involvement and engagement · 2025Article
- Translating Features to Findings: Deep Learning for Melanoma Subtype Prediction.Dermatopathology (Basel, Switzerland) · 2025Review
8 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
46 authors.
Funding
Abstract
Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.