OMERACT Core outcome measurement set for shared decision making in rheumatic and musculoskeletal conditions: a scoping review to identify candidate instruments.

OBJECTIVES: Shared decision making (SDM) is a central tenet in rheumatic and musculoskeletal care. The lack of standardization regarding SDM instruments and outcomes in clinical trials threatens the comparative effectiveness of interventions. The Outcome Measures in Rheumatology (OMERACT) SDM Working Group is developing a Core Outcome Set for trials of SDM interventions in rheumatology and musculoskeletal health. The working group reached consensus on a Core Outcome Domain Set in 2020. The next step is to develop a Core Outcome Measurement Set through the OMERACT Filter 2.2. METHODS: We conducted a scoping review (PRISMA-ScR) to identify candidate instruments for the OMERACT Filter 2.2 We systematically reviewed five databases (Ovid MEDLINE®, Embase, Cochrane Library, CINAHL and Web of Science). An information specialist designed search strategies to identify all measurement instruments used in SDM studies in adults or children living with rheumatic or musculoskeletal diseases or their important others. Paired reviewers independently screened titles, abstracts, and full text articles. We extracted characteristics of all candidate instruments (e.g., measured construct, measurement properties). We classified candidate instruments and summarized evidence gaps with an adapted version of the Summary of Measurement Properties (SOMP) table. RESULTS: We found 14,464 citations, read 239 full text articles, and included 99 eligible studies. We identified 220 potential candidate instruments. The five most used measurement instruments were the Decisional Conflict Scale (traditional and low literacy versions) (n=38), the Hip/Knee-Decision Quality Instrument (n=20), the Decision Regret Scale (n=9), the Preparation for Decision Making Scale (n=8), and the CollaboRATE (n=8). Only 44 candidate instruments (20%) had any measurement properties reported by the included studies. Of these instruments, only 57% matched with at least one of the 7-criteria adapted SOMP table. CONCLUSION: We identified 220 candidate instruments used in the SDM literature amongst people with rheumatic and musculoskeletal diseases. Our classification of instruments showed evidence gaps and inconsistent reporting of measurement properties. The next steps for the OMERACT SDM Working Group are to match candidate instruments with Core Domains, assess feasibility and review validation studies of measurement instruments in rheumatic diseases or other conditions. Development and validation of new instruments may be required for some Core Domains.

Reliability of vulvar blood perfusion in women with provoked vestibulodynia using laser Doppler perfusion imaging and laser speckle imaging.

BACKGROUND: Microvascular assessment has become increasingly used in gynecology to better understand the pathophysiology of various vulvar conditions and to study sexual function. Alteration in blood perfusion of the vulvar area has been observed using laser technologies in women with provoked vestibulodynia (PVD), the leading cause of vulvar pain. However, no studies have thus far investigated the reliability of and agreement between lasers for evaluating vulvar blood perfusion. OBJECTIVES: The main objective was to investigate the between-session reliability of the laser Doppler perfusion imaging (LDPI) and laser speckle contrast imaging (LSCI) for assessing blood perfusion of the vulvar vestibule in women with PVD. Secondary aims were to evaluate the association and agreement between the two laser technologies. METHODS: Twenty-six women with PVD participated in the study. Blood perfusion of the vulvar vestibule was assessed with LDPI and LSCI during two sessions 2 to 4 weeks apart. Blood perfusion was analyzed in five specific areas of the vulvar vestibule: 1) 3 o'clock site, 2) 6 o'clock site, 3) 9 o'clock site, 4) central area (delimited by areas 1, 2 and 3), and 5) posterior fourchette. The reliability of the measurements of the two instruments was calculated with intraclass correlation coefficients (ICCs), standard errors of measurement (SEMs) and coefficients of variation (CVs). Paired t-tests were also computed to compare the CVs of each laser technology. The association and agreement between LDPI and LSCI measurements were evaluated by Pearson's correlation coefficients and Bland-Altman plots, respectively. RESULTS: Excellent reliability was found for LDPI (ICCs = 0.78-0.80, p < 0.001, SEMs = 16.1-47.9) and LSCI measurements (ICCs = 0.75-0.81, p ≤ 0.001, SEMs = 17.0-52.2) for all vulvar vestibule areas. However, CVs were significantly higher using LDPI (CVs = 15.1-19.8) when compared to LSCI (CVs = 7.0-11.6) for all areas (p ≤ 0.031), except for area 4 (p = 0.079). Significant correlations were found between LDPI and LSCI for all areas (r = 0.58-0.89, p ≤ 0.003). Bland-Altman plots revealed a systematic difference between LDPI and LSCI measurements. CONCLUSION: Findings show that both LDPI and LSCI measurements are reliable for assessing blood perfusion of the vulvar vestibule in women with PVD. The LSCI appears to be a more reliable measurement as it presents less variation than LDPI. Finally, although LDPI and LSCI measurements are related, the systematic difference observed between them makes it impossible to compare absolute units.

Reliability and Convergent Validity of the Algometer for Vestibular Pain Assessment in Women with Provoked Vestibulodynia.

OBJECTIVE: Women with provoked vestibulodynia (PVD) suffer pain at the entry of the vagina elicited by pressure as during vaginal penetration. To quantify vestibular pain, we developed a new instrument, an algometer. The aim of this study was to investigate the test-retest reliability of the algometer and evaluate its convergent validity for vestibular pain assessment in women with PVD. METHODS: Twenty-six women with PVD participated in the study. Vestibular pain was assessed with the new algometer and the already known vulvalgesiometer during two different sessions 2 to 4 weeks apart. At each session, the pressure pain threshold (PPT) and pressure pain tolerance (PPTol) were measured twice at the 3, 6, and 9 o'clock sites of the vestibule in random order. The test-retest reliability (intra- and inter-session) of the algometer was calculated using the intraclass correlation coefficient (ICC) and standard error of measurement (SEM). Its convergent validity was evaluated by the correlation coefficients between PPTs and PPTols measured by the algometer and those measured with the vulvalgesiometer. RESULTS: Intra-session reliability at all three sites for PPTs and PPTols in both sessions was excellent (ICC = 0.859 to 0.988, P ≤ 0.002). Inter-session reliability was good to excellent (ICC = 0.683 to 0.922, SEM = 15.06 to 47.04 g, P ≤ 0.001). Significant correlations were found between the two tools for all sites for PPTs (r = 0.500 to 0.614, P ≤ 0.009) and PPTols (r = 0.809 to 0.842, P < 0.001). DISCUSSION: Findings showed that the algometer is a reliable and valid instrument for measuring PPTs and PPTols in the vestibular area in women with PVD. This technology is promising for pinpointing treatment mechanisms and efficacy.