OBJECTIVE: As the importance of the patient\'s perspective on treatment outcome is becoming increasingly clear, the availability of patient-reported outcome measures (PROMs) has grown accordingly. There remains insufficient information regarding the quality of PROMs in patients with soft-tissue sarcomas (STSs). The objectives of this systematic review were (1) to identify all PROMs used in STS patients and (2) to critically appraise the methodological quality of these PROMs.
METHODS: Literature searches were performed in MEDLINE and Embase on April 22, 2024. PROMs were identified by including all studies that evaluate (an aspect of) health-related quality of life in STS patients by using a PROM. Second, studies that assessed measurement properties of the PROMs utilized in STS patients were included. Quality of PROMs was evaluated by performing a COSMIN analysis.
RESULTS: In 59 studies, 39 PROMs were identified, with the Toronto Extremity Salvage Score (TESS) being the most frequently utilized. Three studies evaluated methodological quality of PROMs in the STS population. Measurement properties of the TESS, Quick Disability of the Arm, Shoulder and Hand (QuickDASH) and European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) were reported. None of the PROMs utilized in the STS population can be recommended for use based on the current evidence and COSMIN analysis.
CONCLUSIONS: To ensure collection of reliable outcomes, PROMs require methodological evaluation prior to utilization in the STS population. Research should prioritize on determining relevant content and subsequently selecting the most suitable PROM for assessment.

BACKGROUND: Since its creation, the Mental Health Literacy Scale (MHLS) has been used worldwide in mental health literacy studies.
OBJECTIVE: This study aimed to systematically evaluate, summarize, and compare the measurement properties of MHLS validation studies.
METHODS: PsycINFO, CINAHL, ERIC, Scopus, Embase, MEDLINE, and PubMed databases were searched from May 30, 2015, to December 31, 2023. Peer-reviewed studies validating the MHLS and its measurement properties were included, irrespective of language, study population, and setting. Studies using the MHLS as an outcome measure, as a comparative instrument to validate another instrument, or using other MHL measures and grey literature was excluded.
RESULTS: Of the 685 search results, 16 studies were deemed eligible. The COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) RoB criteria showed 15/15 studies exhibited \'Very Good\' or \'Adequate\' internal consistency, 3/6 reliability, 1/8 content validity, 14/14 structural validity, 6/7 hypothesis testing for convergent validity, 2/7 hypothesis testing for known-group validity, and 0/1 error measurement. The Cronbach\'s alpha ranged from 0.720 to 0.890, and the Intra-class Correlation Coefficient ranged from 0.741 to 0.99, while content validity was limited regarding the quality of evidence rating. The four-factor and unidimensional structures were 35.7 % and 28.6 %, respectively, the most common models.
CONCLUSIONS: The MHLS exhibited strong evidence of construct validity and reliability, ensuring consistent and accurate evaluation of MHL and improving research credibility and generalizability. However, the low number of identical language versions of MHLS studies prohibited statistical pooling and quantitative summaries.

BACKGROUND: Medication Treatment Satisfaction (M-TS) from the patients\' perspective is important for comprehensively evaluating the effect of medicines. The extent to which current patient-reported outcome measures (PROMs) for M-TS are valid, reliable, responsive, and interpretable remains unclear. To assess the measurement properties of existing PROMs for M-TS and to highlight research gaps.
METHODS: Using PubMed, Embase (Ovid), Cochrane library (Ovid), IPA (Ovid), PsycINFO, Patient-Reported Outcome and Quality of Life Questionnaires biomedical databases, and four Chinese databases, we performed a systematic search for studies addressing the development and validation of PROMs for M-TS. Based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline, pairs of reviewers independently assessed the measurement properties of the PROMs and rated the quality of evidence on the measurement properties of each PROM. (The Open Science Framework registration: https://doi.org/10.17605/OSF.IO/8S5ZM ).
RESULTS: This review identified 69 PROMs for M-TS in 114 studies (four generic, 32 disease-specific, and 33 drug-specific) of which 60 were intended for adults. All provided limited or no information regarding interpretability. Most demonstrated appropriate construct validity including convergent validity (39/69) and discriminative or known-groups validity (40/69) (high to moderate quality of evidence). Only a few provided evidence of sufficient content validity (8/69), structural validity (13/69), and internal consistency (11/69). Of 38 PROMs reporting test-retest reliability, results in 24 provided evidence of satisfactory test-retest reliability (18 with high to moderate, 6 with low to very low quality of evidence). Few PROMs reported responsiveness (16/69). Two generic PROMs (Treatment Satisfaction Questionnaire for Medication initial Version 1.4, TSQM-1.4; Treatment Satisfaction with Medicines Questionnaire, SATMED-Q) and one drug-specific PROM (Insulin Treatment Satisfaction Questionnaire, ITSQ) demonstrated both satisfactory validity and reliability.
CONCLUSIONS: Most existing PROMs for M-TS require further exploration of measurement properties. Reporting guidelines are needed to enhance the reporting quality of the development and validation of PROMs for M-TS.

OBJECTIVE: To extensively review Patient Reported Outcome Measures (PROMs) used to assess outcomes in persons with hand fractures in terms of their psychometric properties.
METHODS: A COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodological review was conducted. Six electronic databases were searched (Medline, Embase, Scopus, Web of Science, PsycINFO, CINAHL) for studies evaluating the psychometric properties of PROMs assessing recovery from hand fracture. Titles and abstracts, full text review, quality assessment and data extraction were performed by two reviewers. Any disagreements were resolved after review by a third, expert reviewer. Quality assessment of included studies was performed using the COSMIN checklist.
RESULTS: This COSMIN review found that there were only 4 studies that fulfilled the inclusion criteria in terms of assessing measurement properties of PROMs in hand fractures. Only the construct validity of the Disabilities of the Arm, Shoulder, and Hand (DASH), the Quick DASH (QDASH) and the Duruoz Hand Index (DHI), and the responsiveness of the DASH, the Patient Specific Functional Scale (PSFS), the Patient-Rated Wrist and Hand Evaluation (PRWHE) and the Michigan Hand Outcomes Questionnaire (MHQ) were assessed in these studies. The overall rating of the studies was assessed as insufficient or indeterminate and quality of evidence was assessed as moderate, low, or very low by our team.
CONCLUSIONS: This study identified that there is a lack of evidence in the medical literature with regards to the measurement properties of PROMs in patients with hand fractures. The 4 included studies do not provide good quality data to support the use of these PROMS in patients with hand fractures. There is a need for more studies for more PROMs. This has important consequences for how outcomes will be measured in clinical studies in hand research and in clinical practice.
Hand fractures are some of the most common types of fractures in adults. They affect patients in the short term with everyday activities and can have a long-term impact especially on people who use their hands a lot at work and at home. The recovery from a hand fracture, with whatever treatment, can be captured by questionnaires completed by patients at frequent time intervals. We looked at whether questionnaires, which could do so for these patients, have been assessed in previous studies. Even though this is an important topic, we only found a handful of studies which have done so, and these were not very robust in their assessment. This study indicates that there needs to be more work in the field which will be very helpful for clinical practice and future research.

OBJECTIVE: Systematic reviews of patient-reported outcome measures (PROMs) are important tools to select the most suitable PROM for a study or clinical application. Conducting these reviews is challenging, and the quality of these reviews needs to be improved. We updated the COSMIN guideline for systematic reviews of PROMs, including the COSMIN Risk of Bias checklist, and the COSMIN criteria for good measurement properties.
METHODS: Adaptations to the methodology were based on our experience with applying the COSMIN guideline, through discussions among the authors, and results from two related Delphi studies.
RESULTS: The updated guideline places more emphasis on key aspects that are often missing or sub optimally conducted in published systematic reviews of PROMs, such as formulating a well-defined research question and developing a comprehensive search strategy, assessing risk of bias, applying criteria for good measurement properties, summarizing results, and grading the quality of the evidence. We also stress the importance of evaluating the measurement properties of each subscale of a PROM separately and evaluating content validity of all included PROMs.
CONCLUSIONS: The quality of systematic reviews of PROMs can be improved by using this updated version of the COSMIN guideline for systematic reviews of PROMs. Improved quality will lead to better PROM selection and increased standardization of PROM use.
Patient-reported outcome measures (PROMs) are questionnaires that measure aspects of health from the patient perspective. To measure a specific health aspect, often dozens of PROMs are available. To choose the best PROM, a systematic review of PROMs can be conducted, in which all information on the quality and feasibility of each available PROM is collected, rated, and compared. Based on such a review a choice for the most suitable PROM for a certain study or clinical application can be made. However, conducting a systematic review of PROMs is very challenging, because nine quality aspects of PROMs need to be taken into account.In this article, we present an updated step-by-step guideline for conducting systematic reviews of PROMs. Each of these steps is described in detail in an accompanying manual. This updated guideline helps researchers to conduct systematic reviews of PROMs in a systematic and transparent way. It also helps readers of systematic reviews to understand how the review was conducted and to check the conclusions about which PROMs are recommended based on their quality.

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.

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.
UNASSIGNED: 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.

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.

BACKGROUND: Despite developing a polypharmacy core outcome set (COS) in primary care, it is not clear how these outcomes should be measured.
OBJECTIVE: To select outcome measurement instruments (OMIs) for a COS targeting appropriate polypharmacy in older patients in primary care.
METHODS: 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.\'
CONCLUSIONS: OMIs were selected for a limited number of outcomes in the polypharmacy COS. Future research should identify suitable OMIs for the remaining four outcomes.

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.
CONCLUSIONS: 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.
BACKGROUND: The protocol has been registered at the International Prospective Register of Systematic Reviews (PROSPERO). The registration number is CRD42023429350.