Psychometric properties for instruments used to measure core outcomes for provoked vestibulodynia: a systematic review
Bibliographic record
Abstract
BACKGROUND: The inconsistency in outcome measures used in clinical trials for provoked vestibulodynia (PVD) makes it difficult to compare the effects of different interventions. In a previous study, we developed a core outcome set (COS) for PVD intervention studies, which determined what to measure. AIM: To establish how to measure the COS, this systematic review presents the evidence base regarding the measurement properties of instruments for the COS. METHODS: The systematic review followed the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines and the Cochrane Handbook. A comprehensive search was conducted in PubMed, PsycInfo, and Embase. OUTCOMES: Content validity for the outcomes was assessed using COSMIN guidelines and the methodological quality of studies, and quality of measurement properties were evaluated using the COSMIN checklist and criteria. The synthesized evidence was graded with the modified grading of recommendations, assessment, development, and evaluation approach. RESULTS: No instrument showed high quality evidence for all measurement properties. Most development studies for the instruments were insufficient due to lack of patient involvement, and content validity was only investigated in the PVD population for one of the instruments assessed. Content validity was therefore largely based on expert opinion. No studies presented results for the structural validity or responsiveness of any of the instruments. For other measurement properties, aspects of construct validity (hypothesis testing) and reliability (including internal consistency) were the most studied. CLINICAL IMPLICATIONS: We established how to measure the COS for PVD, which will be useful for clinical trials. STRENGTHS AND LIMITATIONS: Strengths included the multidisciplinary team and the rigorous methodology. Limitations included overall lack of evidence of content validity for the instruments. CONCLUSION: Based on limited evidence and expert opinion, the following instruments are the most promising for the PVD COS: Insertional pain (sexual), 11-point numerical rating scale (NRS) with specific question/anchors, Insertional pain (non-sexual), Tampon test, and 11-point NRS; Provoked pain by pressure/contact, Vulvalgesiometer; Pain related interference on one's life, the Activity Engagement subscale of the Chronic Pain Acceptance Questionnaire; Pain related interference on sexual life, the Sexual Function Interference subscale of the Vulvar Pain Assessment Questionnaire; Sexual function, Female Sexual Function Index, excluding pain subscale; Pain anxiety, Pain Anxiety Symptom Scale, or the Pain Catastrophizing Scale. No recommendations can be made for Pelvic floor function at this time. Future research is needed to establish strong measurement properties of instruments for the COS.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.083 | 0.314 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.011 | 0.016 |
| Bibliometrics | 0.017 | 0.016 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.006 | 0.006 |
| Open science | 0.003 | 0.003 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".