Systematic Review: Measurement Properties of Patient-Reported Outcome Measures Used to Measure Depression Symptom Severity in Adolescents With Depression.

OBJECTIVE: To systematically evaluate the measurement properties of 12 patient-reported outcome measures (PROMs) used to measure depression symptom severity in adolescents with depression. Depression symptom severity was chosen as the outcome of focus given its importance as an outcome to measure in adolescents with depression across clinical trials and/or care. METHOD: MEDLINE, PsycInfo, Scopus, CINAHL, and Web of Science were searched from year of inception up to December 7th, 2023. Study appraisal (i.e., risk of bias), evaluation of measurement properties, and evidence synthesis followed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. Included studies evaluated at least one of nine measurement properties as detailed in the COSMIN taxonomy within a reported sample or subgroup of youth 12-24 years, with at least 40% meeting criteria for any depressive disorder. RESULTS: Of the 15,560 records identified, 31 studies for seven PROMs were included in the COSMIN appraisal. Although several PROMs have the potential to accurately measure depression symptom severity in adolescents with depression, at this time none of the PROMs can be recommended for use without further evaluative work. High-quality evidence was generally lacking, largely due to few or inconsistent findings, small sample sizes, and other methodological concerns. CONCLUSION: This systematic review of the measurement properties of 12 PROMs used to measure depression symptom severity in adolescents with depression found that none of the PROMs can be recommended for use until further evaluative work is conducted. Clinicians and researchers should proceed with caution when using these PROMs.

Development of a Video Consultation Patient-Satisfaction Questionnaire (vCare-PSQ): A Cross-Sectional Explorative Study.

BACKGROUND: Since the COVID-19 pandemic, the use of video consultation (VC) in primary care has expanded considerably in many countries. VC and other telehealth formats are often touted as a solution to improved health care access, with numerous studies showing high satisfaction with this care format among health professionals and patients. However, operationalization and measurement of patient satisfaction with VC varies across studies and often lacks consideration of dynamic contextual factors (eg, convenience, ease-of-use, or privacy) and doctor-patient relational variables that may influence patient satisfaction. OBJECTIVE: We aim to develop a comprehensive and evidence-based questionnaire for assessing patient satisfaction with VC in general practice. METHODS: The vCare Patient-Satisfaction Questionnaire (the vCare-PSQ) was developed according to the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) guidelines. To achieve our overall objective, we pursued three aims: (1) a validation analysis of an existing patient-satisfaction scale (the PS-14), (2) an assessment of extrinsic contextual factors that may impact patient satisfaction, and (3) an assessment of pertinent intrinsic and relational satisfaction correlates (eg, health anxiety, information technology literacy, trust in the general practitioner, or convenience). For validation purposes, the questionnaire was filled out by a convenience sample of 188 Danish adults who had attended at least 1 VC. RESULTS: Our validation analysis of the PS-14 in a Danish population produced reliable results, indicating that the PS-14 is an appropriate measure of patient satisfaction with VC in Danish patient populations. Regressing situational and doctor-patient relational factors onto patient satisfaction further suggested that patient satisfaction is contingent on several factors not measured by the PS-14. These include information technology literacy and patient trust in the general practitioner, as well as several contextual pros and cons. CONCLUSIONS: Supplementing the PS-14 with dynamic measures of situational and doctor-patient relational factors may provide a more comprehensive understanding of patient satisfaction with VC. The vCare-PSQ may thus contribute to an enhanced methodological approach to assessing patient satisfaction with VC. We hope that the vCare-PSQ format may be useful for future research and implementation efforts regarding VC in a general practice setting.

Assessing social connection for long-term care home residents: Systematic review using COnsensus-based Standards for the selection of health Measurement INstruments guidelines.

Social connection is important for long-term care (LTC) residents' quality of life and care. However, there is a lack of consensus on how to measure it and this limits ability to find what improves and impairs social connection in LTC homes. We therefore aimed to systematically review and evaluate the measurement properties of existing measures of social connection for LTC residents, to identify which, if any, measures can be recommended. We searched eight electronic databases from inception to April 2022 for studies which reported on psychometric properties of a measure of any aspect(s) of social connection (including social networks, interaction, engagement, support, isolation, connectedness, and loneliness) for LTC residents. We used COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines to evaluate the measurement properties reported for each identified measure and make recommendations. We identified 62 studies reporting on 38 measures; 21 measured quality of life, well-being or life satisfaction and included a social connection subscale or standalone items and 17 measures specifically targeted social connection. We found there was little high-quality evidence on psychometric properties such as sufficient content validity (n = 0), structural validity (n = 3), internal consistency (n = 3), reliability (n = 1), measurement error (n = 0), construct validity (n = 4), criterion validity (n = 0) and responsiveness (n = 0). No measures demonstrated satisfactory psychometric properties on all these aspects, so none could be recommended for use. Thirty-four measures have the potential to be recommended but require further research to assess their quality and the remaining four are not recommended for use. Our review therefore found that no existing measures have sufficient evidence to be recommended for assessment of social connection in residents of LTC homes. Further validation and reliability studies of existing instruments or the development of new measures are needed to enable accurate measurement of social connection in LTC residents for future observational and interventional studies. Highlights: Social connection is fundamental to person-centered care in long-term care homes.There is insufficient evidence for the reliability and validity of existing measures.No current measures can be recommended for use based on existing evidence.A reliable and valid measure of social connection is needed for future research.

Development of the occupational stress scale for small and medium-sized enterprise owners for stress prevention measures.

Small and medium-sized enterprise (SME) owners are at an increased risk of mental disorders in addition to stress directly related to their business performance. However, steps to protect SME owners' mental health are lacking, and no occupational stress scale has been developed to accurately understand the real-world situation. Based on a nationwide internet survey of 1,000 Japanese SME owners aged 20-79 years with five or more employees, we developed a novel occupational stress scale for SME owners. The 43-item scale assesses job stress factors and modifying factors (individual, non-work, and buffering factors). The validity and reliability of the scale were verified. The job stress factors were unique among SME owners and differed from those of employees, with moderate positive correlations with both psychological distress and presenteeism. Further, the study revealed the roles of modifying factors; work-family conflict increased presenteeism and psychological distress, while self-care and social support decreased them. The findings provide important insights for assessing psychological stress among SME owners, informing future mental health intervention strategies among this population.

Methodological quality of 100 recent systematic reviews of health-related outcome measurement instruments: an overview of reviews.

PURPOSE: Systematic reviews evaluating and comparing the measurement properties of outcome measurement instruments (OMIs) play an important role in OMI selection. Earlier overviews of review quality (2007, 2014) evidenced substantial concerns with regards to alignment to scientific standards. This overview aimed to investigate whether the quality of recent systematic reviews of OMIs lives up to the current scientific standards. METHODS: One hundred systematic reviews of OMIs published from June 1, 2021 onwards were randomly selected through a systematic literature search performed on March 17, 2022 in MEDLINE and EMBASE. The quality of systematic reviews was appraised by two independent reviewers. An updated data extraction form was informed by the earlier studies, and results were compared to these earlier studies' findings. RESULTS: A quarter of the reviews had an unclear research question or aim, and in 22% of the reviews the search strategy did not match the aim. Half of the reviews had an incomprehensive search strategy, because relevant search terms were not included. In 63% of the reviews (compared to 41% in 2014 and 30% in 2007) a risk of bias assessment was conducted. In 73% of the reviews (some) measurement properties were evaluated (58% in 2014 and 55% in 2007). In 60% of the reviews the data were (partly) synthesized (42% in 2014 and 7% in 2007); evaluation of measurement properties and data syntheses was not conducted separately for subscales in the majority. Certainty assessments of the quality of the total body of evidence were conducted in only 33% of reviews (not assessed in 2014 and 2007). The majority (58%) did not make any recommendations on which OMI (not) to use. CONCLUSION: Despite clear improvements in risk of bias assessments, measurement property evaluation and data synthesis, specifying the research question, conducting the search strategy and performing a certainty assessment remain poor. To ensure that systematic reviews of OMIs meet current scientific standards, more consistent conduct and reporting of systematic reviews of OMIs is needed.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Protocol for a systematic review evaluating psychometric properties and gender-related measurement (non)invariance of self-report assessment tools for autism in adults.

BACKGROUND: Given the recent evidence on gender differences in the presentation of autism, there is an increasing concern that current tools for autism do not adequately capture traits more often found in women. If tools for autism measure autistic traits differently based on gender alone, their validity may be compromised as they may not be measuring the same construct across genders. Measurement invariance investigations of autism measures can help assess the validity of autism constructs for different genders. The aim of this systematic review is to identify and critically appraise the psychometric properties of all self-report tools for autism in adults that meet two criteria: (a) they have been published since or included in the NICE (2014) recommendations, and (b) they have undergone gender-related measurement invariance investigations as part of their validation process. METHODS: A search of electronic databases will be conducted from 2014 until the present using MEDLINE, Embase, and PsycINFO using predefined search terms to identify eligible studies. The search for grey literature will include sources such as OpenGrey, APA PsycEXTRA, and Scopus. Two reviewers will independently screen titles, abstracts, and full texts for eligibility. The references of included studies will be searched for additional records. The methodological quality of the studies will be evaluated using the COSMIN Risk of Bias checklist, while psychometric quality of findings will be assessed based on criteria for good measurement properties and ConPsy checklist. The quality of the total body of evidence will be appraised using the approach outlined in the modified GRADE guidelines. DISCUSSION: This systematic review will be among the first to assess the psychometric properties and gender-related measurement invariance of self-reported measures for autism in adults that were published since (or included in) NICE (2014) guidelines. The review will provide recommendations for the most suitable tool to assess for autism without gender bias. If no such measure is found, it will identify existing tools with promising psychometric properties that require further testing, or suggest developing a new measure. SYSTEMATIC REVIEW REGISTRATION: The protocol has been registered at the International Prospective Register of Systematic Reviews (PROSPERO). The registration number is CRD42023429350.

Selection of outcome measurement instruments for a core outcome set for trials aimed at improving appropriate polypharmacy in older people in primary care: a Delphi consensus study.

BACKGROUND: Despite developing a polypharmacy core outcome set (COS) in primary care, it is not clear how these outcomes should be measured. AIM: To select outcome measurement instruments (OMIs) for a COS targeting appropriate polypharmacy in older patients in primary care. METHOD: Following the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline, OMIs were identified from a Cochrane review focusing on appropriate polypharmacy. The quality of OMIs was assessed using a published checklist. Subsequently, two rounds of Delphi questionnaires were conducted via the SoGoSurvey® platform, engaging stakeholders (researchers, clinicians and journal editors specialising in geriatric primary care) to achieve consensus on OMIs using a scale encompassing "agree", "disagree", or "unsure". Consensus was achieved if 70% or more participants chose "agree" and 15% or fewer chose "disagree." RESULTS: The quality of 20 OMIs identified from the Cochrane review was evaluated. Seven OMIs were selected based on meeting the COSMIN guideline's minimum requirements. Out of 188 potential participants, 57 (30.3%) consented to participate. Rounds 1 and 2 of Delphi exercises were completed by 50 respondents, achieving agreement on three OMIs: 'number of serious adverse drug reactions (ADRs)' (98%), 'number of deaths' (76%), and 'number of patients who fell' (70%) for measuring 'serious ADRs,' 'mortality,' and 'falls,' respectively. No agreement was reached for 'medication appropriateness,' 'medication side-effects,' 'quality of life,' and 'medication regimen complexity.' CONCLUSION: OMIs were selected for a limited number of outcomes in the polypharmacy COS. Future research should identify suitable OMIs for the remaining four outcomes.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Measurement properties of the Iranian version of the breast cancer perception scale (BCPS) according to the COSMIN checklist.

BACKGROUND: Breast cancer is a prevalent cancer characterized by its aggressive nature and potential to cause mortality among women. The rising mortality rates and women's inadequate perception of the disease's severity in developing countries highlight the importance of screening using conventional methods and reliable scales. Since the validity and reliability of the breast cancer perception scale (BCPS) have not been established in the Iranian context. Therefore, this study aimed to determine the measurement properties of the BCPS in women residing in Tabriz, Iran. METHODS: The present study comprised a cross-sectional design, encompassing a sample of 372 Iranian women. The participants were selected through a multi-stage cluster random sampling technique conducted over a period spanning from November 2022 to February 2023. The measurement properties of the Iranian version of BCPS were assessed following the guidelines outlined in the COSMIN checklist. This involved conducting various steps, including the translation process, reliability testing (internal consistency, test-retest reliability, and measurement error), and methodological tests for validity (content validity, face validity, construct validity, and hypothesis testing). The study also investigated the factors of responsiveness and interpretability. The presence of floor and ceiling effects was assessed. RESULTS: The internal consistency of the scale was assessed using Cronbach's alpha, yielding a satisfactory value of 0.68. Additionally, McDonald's omega (95% CI) was computed, resulting in a value of 0.70 (0.66 to 0.74). Furthermore, the test-retest reliability was evaluated, revealing a high intraclass correlation coefficient (ICC) of 0.97 (95% CI: 0.94 to 0.99). The CVI, CVR, and impact scores of the BCPS were determined to be 0.98, 0.95, and 3.70, respectively, indicating favorable levels of content and face validity. To assess construct validity, an examination of the Exploratory Factor Analysis (EFA) was conducted on a set of 24 items. This analysis revealed the presence of six distinct factors, which collectively accounted for 52% of the cumulative variance. The fit indices of the validity model (CFI = 0.91, NFI = 0.96, RFI = 0.94, TLI = 0.90, χ2/df = 2.03, RMSEA = 0.055 and SRMR = 0.055) were confirmed during the confirmatory factor analysis (CFA). The overall score of BCPS exhibited a ceiling effect of 0.3%. The floor effect observed in the overall score (BCPS) was found to be 0.5%. Concerning the validation of the hypothesis, Spearman's correlation coefficient of 0.55 was obtained between the BCPS and the QLICP-BR V2.0. This correlation value signifies a statistically significant association. Furthermore, it is worth noting that the minimum important change (MIC) of 3.92 exhibited a higher value compared to the smallest detectable change (SDC) of 3.70, thus suggesting a satisfactory level of response. CONCLUSIONS: The obtained findings suggest that the Iranian version of the BCPS demonstrates satisfactory psychometric properties for assessing the perception of breast cancer among Iranian women. Furthermore, it exhibits favorable responsiveness to clinical variations. Consequently, it can serve as a screening instrument for healthcare professionals to comprehend breast cancer and as a reliable tool in research endeavors.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

BACKGROUND AND OBJECTIVE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: This paper was jointly developed by Journal of Clinical Epidemiology, Quality of Life Research, Journal of Patient Reported Outcomes, Health and Quality of Life Outcomes and jointly published by Elsevier Inc, Springer Nature Switzerland AG, and BioMed Central Ltd., part of Springer Nature. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. Either citation can be used when citing this article.

Measurement properties of the Foot Function Index (FFI) questionnaire: A systematic review.

OBJECTIVE: Large numbers of people are subject to alterations and pathologies in the foot. To quantify how these problems of foot function affect the quality of life, clinicians and researchers have developed measures such as the Foot Function Index (FFI). Our aim is to determine the methodological quality of the FFI including adaptations to other languages. DATA SOURCES: The studies considered in this review were extracted from the PubMed, Embase and CINAHL databases. The inclusion criteria were followed: (1) studies of patients with no previous foot or ankle pathology and aged over 18 years; (2) based on English-language patient-reported outcome measures that assess foot function; (3) the patient-reported outcome measures should present measurement properties based on COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) criteria. REVIEW METHODS: The systematic review was conducted following the COSMIN criteria to establish the methodological quality of the original FFI, together with its variants and adaptations. The last search was carried out in May 2024. RESULTS: Of the 1994 studies obtained in the preliminary search, 20 were eligible for inclusion in the final analysis. These results are the validations and cross-cultural adaptations to the following languages: the original FFI has cross-cultural adaptation in 13 languages and the FFI-Revised Short Form has been adapted and validated for use in 2 languages. CONCLUSION: In terms of methodological quality, the FFI-Revised Short Form questionnaire is a valuable instrument for evaluating ankle and foot function and could usefully be expanded to be available in more languages.

Connor-Davidson Resilience Scale: a systematic review psychometrics properties using the COSMIN.

Background: Psychometrical evaluation of persons of diverse contexts and different populations, including general or clinical. Objective: This review study aimed to evaluate the psychometrics quality of resilience scales. Methods: International and Iranian databases were searched with MESH terms, including "psychometric", "validity", "reliability", "Connor-Davidson resilience scale", "Resilience scale", for published articles up to 1 February 2023. For each of the selected studies, the risk of bias was evaluated using the COSMIN Risk of Bias Checklist. Then the COSMIN checklist was used to evaluate the entire text of the article for methodological quality. Results: Considering the inclusion criteria, 80 documents were evaluated. According to the COSMIN's criteria for evaluating the risk of bias, the current study findings revealed the included studies' limitations in assessing the three versions of CD-RISC cross-cultural and content validity as well as their stability (e.g. conducting test re-test), whereas the majority of psychometric studies of CD-RISC-25, and CD-RISC-2 rated as very good or adequate in terms of structural validity. In terms of quality assessment of the included studies, the current study indicated that investigating the structural validity of the CD-RISC was mainly done based on exploratory factor analysis (EFA), and confirmatory factor analysis was absent. Conclusion: The general result indicates the acceptability of the quality of the studies. However, concerns for measurement properties such as responsiveness and criterion validity as well as the standard error of measurement have been neglected.

Assessment of the measurement properties of the Peabody Developmental Motor Scales-2 by applying the COSMIN methodology.

The Peabody Developmental Motor Scales-2 (PDMS-2) has been used to assess the gross and fine motor skills of children (0-6 years); however, the measurement properties of the PDMS-2 are inconclusive. Here, we aimed to systematically review the measurement properties of PDMS-2, and synthesize the quality of evidence using the Consensus-based Standards for the Selection of Health Measurements Instruments (COSMIN) methodology. Electronic databases, including PubMed, EMBASE, Web of Science, CINAHL and MEDLINE, were searched for relevant studies through January 2023; these studies used PDMS-2. The methodological quality of each study was assessed by the COSMIN risk-of-bias checklist, and the measurement properties of PDMS-2 were evaluated by the COSMIN quality criteria. Modified GRADE was used to evaluate the quality of the evidence. We included a total of 22 articles in the assessment. Among the assessed measurement properties, the content validity of PDMS-2 was found to be sufficient with moderate-quality evidence. The structural validity, internal consistency, test-retest reliability and interrater reliability of the PDMS-2 were sufficient for high-quality evidence, while the intrarater reliability was sufficient for moderate-quality evidence. Sufficient high-quality evidence was also found for the measurement error of PDMS-2. The overall construct validity of the PDMS-2 was sufficient but showed inconsistent quality of evidence. The responsiveness of PDMS-2 appears to be sufficient with low-quality evidence. Our findings demonstrate that the PDMS-2 has sufficient content validity, structural validity, internal consistency, reliability and measurement error with moderate to high-quality evidence. Therefore, PDMS-2 is graded as 'A' and can be used in motor development research and clinical settings.

Assessing the Psychometric Properties of the Illness Management and Recovery Scale: A Systematic Review Using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN).

The Illness Management and Recovery Scale (IMR-S) is based on the IMR program, developed to assess the recovery process for people with severe mental disorders by considering the perceptions of clients and clinicians involved in it. The aim of this study was to analyze the psychometric properties of the IMR-S so as to determine the reliability and suitability of its scores for evaluating recovery. Two coders searched five databases for studies, published between January 2004 and May 2023, that describe the psychometric assessment of the IMR-S. Studies were assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist. Finally, 46 papers were included. Methodological quality was very good for most of the studies that provide information on internal validity, and limited for those that report on responsiveness. Measurement properties were positive for convergent validity and measurement error. The quality of evidence was high for structural validity studies. Although this study only includes research published in English and may have overlooked certain psychometric properties evaluated in studies published in other languages, our findings suggest that the IMR-S is a valid and reliable instrument, demonstrating its potential to offer guidance for clinical practice.

Translation, contextual adaptation, and reliability of the Danish Concept of Pain Inventory (COPI-Adult (DK)) - A self-reported outcome measure.

OBJECTIVES: Pain is a growing concern globally, and an individual and societal burden. Pain science education (PSE) is a promising avenue for managing chronic pain, but targeted PSE is needed. The Concept of Pain Inventory for Adults (COPI-Adult) is a newly developed self-reported outcome measure aimed at targeting PSE. It is currently unavailable in Danish and has unknown reliability. The aims of this study were (1) to translate and contextually adapt to Danish and (2) to determine reliability in terms of test-retest reliability, internal consistency, and measurement error. METHODS: Step (1) was as follows: a dual panel approach was used to translate, contextually adapt into a Danish version. Step (2) was follows: a heterogenic sample of Danish adults >18 years (n = 150) was included in the test-retest analysis, test interval between 7 and 14 days, both answered via REDCap-link. Based on COSMIN recommendations, the following reliabilities were estimated: the test-retest using intraclass correlation coefficient (ICC2.1) and internal consistency using Cronbach's alpha level. Measurement error in terms of standard error of measurement (SEM) and smallest detectable change (SDC) were calculated. RESULTS: Step (1) was as follows: the first panel reached 100% consensus on the wording of the COPI-Adult (DK), with no alterations by the second panel. Step (2) was as follows: good to excellent test-retest reliability was found with ICC2.1 value (95% confidence interval) 0.88 (0.84-0.91), excellent internal consistency for the 13-item COPI-Adult (DK) with α = 0.939, SEM of 2.53, and SDC of 7.02. DISCUSSION: The COPI-Adult (DK) was successfully translated and contextually adapted. It is a reliable questionnaire with excellent internal consistency. The COPI-Adult (DK) shows promise in research and clinical practice.

A blueprint for patient and public involvement in the development of a reporting guideline for systematic reviews of outcome measurement instruments: PRISMA-COSMIN for OMIs 2024.

BACKGROUND: In recent years, projects to develop reporting guidelines have attempted to integrate the perspectives of patients and public members. Best practices for patient and public involvement (PPI) in such projects have not yet been established. We recently developed an extension of PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), to be used for systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) for OMIs 2024. Patients and public members formed a small but impactful stakeholder group. We critically evaluated the PPI component in this project and developed recommendations for conducting PPI when developing reporting guidelines. MAIN TEXT: A patient partner was an integral research team member at the project development and grant application stage. Once the project started, five patient and public contributors (PPCs) were recruited to participate in the Delphi study; three PPCs contributed to subsequent steps. We collected quantitative feedback through surveys; qualitative feedback was garnered through a focus group discussion after the Delphi study and through debrief meetings after subsequent project activities. Feedback was thematically combined with reflections from the research team, and was predominantly positive. The following themes emerged: importance of PPI partnership, number of PPCs involved, onboarding, design of Delphi surveys, flexibility in the process, complexity of PPI in methodological research, and power imbalances. Impacts of PPI on the content and presentation of the reporting guideline were evident, and reciprocal learning between PPCs and the research team occurred throughout the project. Lessons learned were translated into 17 recommendations for future projects. CONCLUSION: Integrating PPI in the development of PRISMA-COSMIN for OMIs 2024 was feasible and considered valuable by PPCs and the research team. Our approach can be applied by others wishing to integrate PPI in developing reporting guidelines.

Screen11: validating a screening instrument for voice disorders in accordance with the COSMIN framework.

PURPOSE: Although numerous patient-reported outcome measures have been developed and validated to quantify the impact of voice problems on different aspects of life, to our knowledge no screening instrument exists that specifically captures voice disorders in a retrospective fashion. The aim of the present study was to examine the psychometric properties and diagnostic validity of a retrospective voice screening method, Screen11, according to the COSMIN framework for health-related, patient-reported outcome measures. The items in Screen11 have been used to establish the prevalence of voice disorders in both general and occupation-specific populations in the Nordic countries. However, the instrument has not been validated. METHODS: The voice patient group (n = 54) in this study comprised of patients from the Turku University Central Hospital phoniatric outpatient clinic seeking help for their voice problems. For these voice patients, we recruited voice-healthy controls (n = 61) who matched in terms of gender, age, and occupation. The participants responded to the Screen11 questionnaire along with the VHI and the VAPP. RESULTS: The results of the initial exploratory factor analysis showed that all the Screen11 items loaded on a common underlying latent factor. Furthermore, Screen11 had high internal consistency (α = .93) and correlated sufficiently with other voice questionnaires. CONCLUSIONS: The results indicate that Screen11, which screens for possible voice disorders at an early stage, was successfully validated. With respect to its diagnostic validity, the Screen11 sum score is preferable. A threshold of ≥ 15 should be used for differentiating patients with possible voice disorders from those with healthy voices.

Measurement properties of tools used to assess self-harm in autistic and general population adults.

Autistic people are at increased risk of experiencing self-harm compared to the general population. However, it is unclear which tools are being used to assess self-harm in autistic people, or whether existing tools need to be adapted for this group. This two-stage systematic review aimed to identify tools used to assess self-harm in autistic and general population adults, evaluate these tools on their measurement properties, and make recommendations for their appropriate use in research and clinical practice. Four databases were systematically searched (PsycINFO, Embase, MEDLINE and Web of Science). Eight frequently used self-harm assessment tools were identified and assessed for risk of bias, criteria for good measurement properties, and quality of evidence using the COSMIN checklist. Of these, two tools had sufficient evidence of internal consistency (ISAS, QNSSI), and one had been frequently used with autistic adults (NSSI-AT). These three tools may have potential for use with autistic adults but require further investigation for content validity and measurement properties in the autistic population. More research and potential adaptations to current self-harm assessment tools are recommended in order to better conceptualise and understand self-harm and its measurement in autism.