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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., (© 2024. The Author(s).)

Objective: This study was to evaluate measurement properties of the Chinese version of the Brief Inventory of Perceived Stress (BIPS-C) and confirm possible solutions for measuring the constructs underlying perceived stress., Methods: A total of 1356 community residents enrolled and were randomly split into two halves. The first half was used to explore the underlying constructs of the BIPS-C by exploratory graph analysis (EGA) and the second half was used to compare and confirm the constructs by confirmatory factor analysis (CFA)., Results: The EGA identified a one-factor model of the BIPS-C with an accuracy of 99.3%. One-factor, three-factor, second-order, and bifactor models were compared by CFAs. The bifactor model with one general and three specific factors was found to be the most adequate [comparative fit index (CFI) = 0.990; Tucker-Lewis index (TLI) = 0.979; root mean square error of approximation (RMSEA) = 0.058] and was superior to the other models. The related bifactor indices showed a stronger existence of the general factor. The bifactor model of the BIPS-C also showed adequate internal consistency with McDonald's omega and omega subscales ranging from moderate to strong (0.677-0.869)., Conclusion: The BIPS-C demonstrates sufficient measurement properties for assessing general perceived stress., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: To identify utility-based patient-reported outcome measures (PROMs) for assessing health-related quality of life (HRQoL) in cardiac rehabilitation and secondary prevention programs (CR) and appraise existing evidence on their measurement properties. Secondly, to link their items to the International Classification of Functioning Disability and Health (ICF) and the International Consortium of Health Outcome Measures (ICHOM) domains for cardiovascular disease (CVD)., Methods: Eight databases were searched. The review followed the COSMIN and JBI guidelines for measurement properties systematic reviews and PRISMA 2020 reporting guidelines. Non-experimental and observational empirical studies of patients ≥ 18 years of age with CVD undergoing CR and assessed quality of life (QoL) or HRQoL using utility-based PROMs or one accompanied by health state utilities were included., Results: Nine PROMs were identified with evidence on measurement properties for three measures: the German translations of SF-12, EQ-5D-5L, and MacNew heart disease HRQoL questionnaire. There was moderate quality evidence for responsiveness and hypothesis testing of the SF-12 and EQ-5D-5L, and high-quality evidence for responsiveness and hypothesis testing for the MacNew. All items of SF-12 and EQ-5D were linked to ICF categories, but four items of the MacNew were not classified or defined. All the PROM domains were mapped onto similar constructs from the ICHOM global sets., Conclusion: Three utility-based PROMs validated in CR were identified: the German versions of the EQ-5D and SF-12 and the MacNew questionnaire. These PROMs are linked to a breadth of ICF categories and all ICHOM global sets. Additional validation studies of PROMs in CR are required., (© 2024. The Author(s).)

Purpose: 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., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: 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., Conclusion: 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., (© 2024. The Author(s).)

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., (© 2024. The Author(s).)

Purpose: There is need for a comprehensive measure of post-stroke fatigue with sound measurement properties. This study aimed to develop the Norwegian Fatigue Characteristics and Interference Measure (FCIM) and assess its content validity, structural validity, and internal consistency., Method: This study consisted of three steps: (1) an expert panel developed version 1.0 of the Norwegian FCIM, (2) its content validity was assessed in cognitive interviews with stroke patients (N = 15), (3) a convenience sample of stroke patients (N = 169) completed an online questionnaire with the FCIM, Fatigue Severity Scale, and sociodemographic information; validity and reliability were assessed using Rasch analysis., Results: FCIM version 1.0 included a 10-item characteristics subscale, a 20-item interference subscale, and two pre-stroke fatigue items. The cognitive interviews revealed content validity issues, resulting in two interference items being removed and five items being flagged but retained for Rasch analysis (version 2.0). Rasch analysis led to removal of four items from the characteristics subscale and six more from the interference subscale. The final six-item characteristics subscale and 12-item interference subscale (version 3.0) both showed adequate fit to the Rasch model with indications of unidimensionality and local independence. The interference subscale had a high person separation index. No significant differential item function (DIF) was found in relation to gender, but one item demonstrated DIF in relation to age., Conclusion: The cognitive interviews and Rasch analysis demonstrated that the Norwegian version of the FCIM has high content validity, structural validity, and internal consistency. Future research should assess its construct validity, reliability, and responsiveness., (© 2023. The Author(s).)

Purpose: This study aimed to systematically identify, appraise, and summarize the psychometric properties of instruments used to measure the quality of dying and death in Asian countries., Methods: The Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) was closely followed. The literature was searched using the following keywords and their synonyms: "death and dying," "measurement," and "Asian country" in CINAHL, PubMed, PsycInfo, Web of Science, and Cochrane Library from inception to April 2021. Two reviewers independently screened titles and abstracts and reviewed the full text. Two other reviewers independently assessed the quality of the identified studies in three steps: methodological quality evaluation, good measurement properties evaluation, and quality of evidence evaluation., Results: This review retrieved 37,195 studies, of which seven were finally included. Four instruments that assessed the quality of dying and death in Asian countries were identified: the Good Death Inventory (GDI), the Good Death Scale (GDS), and two versions of the Quality of Dying and Death (QODD) Questionnaires. All included studies failed to evaluate all the recommended psychometric properties, and none of the instruments provided strong evidence of their quality among Asian populations. Overall, the grade of evidence quality for the GDI was moderate, the highest among all identified instruments., Conclusion: The GDI is by far the most reliable instrument for assessing the quality of dying and death in Asian populations. A lack of validation studies in Asian and Western cultures, however, warrants caution when drawing conclusions from the GDI., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: To translate the ACL-QOL from English to Swedish and evaluate measurement properties for use after surgical and non-surgical management of anterior cruciate ligament (ACL) injury., Methods: The ACL-QOL was translated from English to Swedish and data were pooled from 13 cohorts to enable a comprehensive evaluation of measurement properties in line with COSMIN guidelines. We evaluated internal consistency, test-re-test reliability, measurement error, structural validity [confirmatory factor analysis (CFA)], construct validity and responsiveness (hypothesis testing), and floor/ceiling effects. Results were stratified by time since injury (≤ 1.5 years; 2-10 years, 15-25 years; > 30 years) and ACL management strategy [surgical (n = 1163), non-surgical (n = 570)]., Results: The Swedish ACL-QOL had sufficient internal consistency (total and domain scores) for use in surgically managed (Cronbach's alpha ≥ 0.744) and non-surgically managed (≥ 0.770) ACL-injured individuals at all time-points. Test-re-test reliability was sufficient [intraclass correlation coefficients: all domains > 0.80, total score 0.93 (95% CI 0.86-0.96)]. The standard error of measurement was 5.6 for the total score and ranged from 7.0 to 10.3 for each domain. CFA indicated sufficient SRMR values when using the total score or five domains; however, CFI and RMSEA values did not meet cut-offs for good model fit. Hypothesis testing indicated sufficient construct validity and responsiveness. Floor effects were negligible and ceiling effects were negligible or minor., Conclusion: The Swedish version of the ACL-QOL has sufficient internal consistency, test-re-test reliability, construct validity and responsiveness, for use in people with ACL injury managed with or without ACL surgery. Model fit could be improved and investigation into the source of misfit is warranted., (© 2022. The Author(s).)

Purpose: Ankle fractures are commonly occurring fractures, especially in the aging population, where they often present as fragility fractures. The disease burden and economic costs to the patient and society are considerable. Choosing accurate outcome measures for the evaluation of the management of ankle fractures in clinical trials facilitates better decision-making. This systematic review assesses the evidence for the measurement properties of patient-reported outcome measures (PROMs) used in the evaluation of adult patients with ankle fractures., Methods: Searches were performed in CINAHL, EMBASE, Medline and Google Scholar from the date of inception to July 2021. Studies that assessed the measurement properties of a PROM in an adult ankle fracture population were included. The included studies were assessed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for systematic reviews of PROMs., Results: In total, 13 different PROMs were identified in the 23 included articles. Only the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) presented some evidence on content validity. The Olerud-Molander Ankle Score (OMAS) and Self-reported Foot and Ankle Score (SEFAS) displayed good evidence of construct validity and internal consistency. The measurement properties of the OMAS, LEFS and SEFAS were most studied., Conclusion: The absence of validation studies covering all measurement properties of PROMs used in the adult ankle fracture population precludes the recommendation of a specific PROM to be used in the evaluation of this population. Further research should focus on validation of the content validity of the instruments used in patients with ankle fractures., (© 2022. The Author(s).)

Purpose: Both the International Consortium for Health Outcomes Measurement and the National Institutes of Health recommend the use of Patient-Reported Outcomes Measurement Information System (PROMIS®) measures in clinical care and research for stroke patients. This study aimed to systematically review the literature on the measurement properties and interpretability of PROMIS measures in stroke patients., Methods: Nine databases were searched from January 1st, 2007 till April 12th, 2021 for studies concerning the measurement properties and interpretability of PROMIS measures in stroke patients. The findings of these studies were analyzed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline for systematic reviews of Patient-Reported Outcome Measures (PROMs)., Results: Ten studies were included. The PROMIS Global Health was studied the most: its two subscales had sufficient structural validity in one study of very good quality, sufficient construct validity with > 75% of hypotheses tested confirmed (high GRADE rating), sufficient internal consistency, i.e. α ≥ 0.70 in two studies (high GRADE rating), sufficient reliability, i.e. ICC ≥ 0.70 in one study of doubtful quality, and indeterminate responsiveness in one study of inadequate quality. For other PROMIS measures, the measurement properties and interpretability were limitedly studied., Conclusion: The PROMIS Global Health showed sufficient structural and construct validity and internal consistency in stroke patients. There is a need for further research on content validity, structural validity, and measurement invariance of PROMIS measures in stroke patients. Trial Registration Information: CRD42020203044 (PROSPERO)., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: Chemotherapy-induced peripheral neuropathy (CIPN) is a common toxicity of cancer treatment, with potential to significantly impact cancer survivors' long-term quality of life. Patient reported outcome measures (PROMs) are increasingly utilised to evaluate CIPN. However, guidance remains lacking on how to identify fit for purpose PROMs with considerations necessarily differing when used in various research and in-clinic contexts. This study aimed to evaluate evidence about CIPN PROMs measurement properties and propose considerations to optimize CIPN PROM selection for each purpose., Methods: A systematic review was conducted to identify literature assessing measurement properties of CIPN PROMs. These were evaluated against Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) criteria and International Society for Quality of Life minimum standards. Risk of Bias (RoB) was assessed using the COSMIN RoB checklist., Results: Thirty-nine papers evaluating measurement properties of 13 PROMs were included. The European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy Questionnaire (QLQ-CIPN20) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) were the most commonly investigated PROMs and had the most measurement properties meeting established criteria., Conclusion: The use of the QLQ-CIPN20 and FACT/GOG-Ntx to assess CIPN in research settings has the most supporting evidence. However other considerations including study aims, endpoints and target population also factor into PROM selection and need to be considered more often when determining the most suitable outcome measure. Evidence of CIPN PROMs use in clinical practice is limited and their adoption to individual-patient level management requires more evaluation., (© 2022. The Author(s).)

Purpose: To appraise the measurement properties of generic patient-reported outcome measures (PROMs) measuring postoperative quality of life in adults undergoing elective abdominal surgery., Methods: We conducted a systematic review of PROMs administered after elective abdominal surgery. We systematically searched Ovid MEDLINE, Embase, the Cumulative Index to Nursing & Allied Health Literature database, and the Cochrane Library from earliest available dates to July 24, 2021, using relevant search terms. Articles were included if they reported assessment of measurement properties of a generic PROM/s measuring postoperative quality of life in adults who had undergone elective abdominal surgery. We used the Consensus-based Standards for the selection of health status Measurement Instruments (COSMIN) Risk of Bias checklist to assess methodological quality. We synthesized the data and used the COSMIN criteria for good measurement properties and the Grading of Recommendations, Assessment, Development and Evaluations criteria to rate the certainty of evidence., Results: Of 12,121 identified articles, nine articles assessing five PROMs (SF-6D, EQ-5D, SF-36, SF-12, PROMIS-10) met inclusion criteria. Measurement properties assessed included internal consistency (n = 2), construct validity (n = 5), and responsiveness (n = 8). Two PROMs had high quality evidence for a single measurement property each. The SF-6D demonstrated high quality evidence for responsiveness and the EQ-5D had high quality evidence for construct validity., Conclusion: There is insufficient evidence to support the choice of a specific generic PROM to evaluate quality of life following elective abdominal surgery. Clinicians and researchers should be aware of the current limitations in knowledge of the measurement properties of available PROMs., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: The Patient-Specific Functional Scale (PSFS), Disability of the Arm, Shoulder and Hand (DASH), Quick-DASH, and Shoulder Pain and Disability Index (SPADI) are frequently used instruments in shoulder functional assessment. They are available in Nepali and all but the PSFS has been validated for shoulder assessment. Therefore, the aim of this study was to validate the Nepali PSFS in shoulder pain patients and to compare validity, reliability, and responsiveness of all four instruments to provide a recommendation for their use., Method: Patients attending physiotherapy completed the Nepali PSFS at baseline and follow-up (1-3 weeks). It was tested for reliability using internal consistency (Cronbach's α), intraclass correlation coefficient (ICC), construct validity by hypothesis testing and responsiveness by anchor-based method using Area Under the Curve (AUC). The instruments were compared based on reported measurement properties and patients' preference., Results: 156 patients enrolled at baseline and 121 at follow-up. The PSFS showed sufficient reliability (α = 0.70, ICC = 0.82), construct validity (all three hypotheses met) and responsiveness (AUC = 0.83). Measurement property comparison demonstrated adequate reliability and validity, while PSFS was the most responsive instrument. Patients favoured the verbal rating scale of the DASH/Quick-DASH. The DASH had a lower completion rate for 'culturally sensitive' and 'uncommon' activities., Conclusion: The Nepali PSFS is a reliable, valid, and responsive instrument in shoulder functional assessment. The combined use of the Quick-DASH or SPADI with the PSFS is recommended for a comprehensive assessment of Nepali shoulder pain patients in clinical and research settings. They are shorter, more appropriate to the Nepali context and provide balanced self-evaluation., (© 2022. The Author(s).)

Purpose: This research aimed, first, to identify, summarize, and synthesize the studies reporting the development, translation, and/or psychometric evaluation of PROMs in Arabic-speaking populations and, second, to evaluate the psychometric properties and the translation process of a sample 26 PROMs., Methods: In 2019, PubMed, Web of Science, and SCOPUS were searched for studies reporting the development, translation, or cross-cultural adaptation of patient-reported outcome measures in Arabic-speaking populations, and those including the assessment of one or more psychometric properties as PROMs (including validity, reliability, responsiveness, interpretability) in our target populations were included. The review protocol registration number is CRD42018088991., Results: The search strategy outlined above yielded a total of 3179 titles in the three databases. Of these, 174 English language studies met the inclusion criteria. One hundred thirty-six PROMs were identified. The methodological quality and translation process of PROMs reported by at least two studies (26 PROM instruments, 63 studies) were examined. Internal consistency, reliability, and construct validity were the most frequently reported psychometric properties. Structural validity, cross-cultural validity, responsiveness, and measurement error were largely unreported. The process of developing at least two independent forward translations and back translation of the instrument into the source language were reported by 32 and 43 studies, respectively., Conclusion: There is a need for further investigation of measurement properties of Arabic PROMs measures before routine use can be recommended in clinical practice., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis., Methods: We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence., Results: Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties., Conclusion: Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable., Systematic Review Registration: PROSPERO CRD42020170247., (© 2021. The Author(s).)

Purpose: The aim was to investigate the measurement properties of the EQ-5D-5L utility index in patients after arthroscopic rotator cuff repair (RCR), total shoulder arthroplasty (TSA) or thumb carpometacarpal (CMC I) arthroplasty., Methods: In this prospective study, all patients completed the EQ-5D-5L before surgery and 6 months and 1 year after surgery. In addition, RCR patients completed the Oxford Shoulder Score (OSS), TSA patients completed the Shoulder Pain and Disability Index (SPADI) and CMC I patients completed the brief Michigan Hand Outcomes Questionnaire (brief MHQ) at each designated time point. Construct validity (Pearson's correlation coefficient, r), responsiveness (effect size), minimal important difference (MID), minimal important change (MIC), and floor and ceiling effects of the EQ-5D-5L were determined. To test discriminative ability, EQ-5D-5L utility indices of patients who were in a patient acceptable symptom state (PASS) or not at follow-up were compared using the Mann-Whitney U test., Results: We included 153 RCR, 150 TSA, and 151 CMC I patients. The EQ-5D-5L utility index correlated with the OSS (r = 0.73), SPADI (r = - 0.65) and brief MHQ (r = 0.61). The effect sizes were 1.3 (RCR and CMC I group) and 1.1 (TSA). The MID and MIC ranged from 0.027 to 0.209. Ceiling effects were found. The EQ-5D-5L utility index differed significantly between patients being in a PASS versus patients who were not in a PASS., Conclusion: The EQ-5D-5L utility index shows good construct validity, responsiveness and discriminative ability in patients after arthroscopic RCR, TSA and CMC I arthroplasty and is suitable to quantify quality of life., Clinical Trial Registration: This auxiliary analysis is part of a primary study that was originally registered at ClinicalTrials.gov (NCT01954433) on October 1, 2013., (© 2021. The Author(s).)

Purpose: To develop a set of consensus and empirically based reporting recommendations for primary studies of the measurement properties of patient-reported outcome measures (PROMs)., Methods: This study included four phases: 1. Conducting an extensive literature review of recommendations for reporting of studies testing measurement properties of PROMs; 2. Preparing for the Delphi study by identifying experts; 3. Conducting three Delphi rounds aiming for consensus on the item list of recommendations found in phase 1; 4. Developing the COSMIN reporting guideline and user manual., Results: The literature review resulted in 93 reporting items, included in the first Delphi round. A total of 84 individuals (from 12 countries) agreed to participate in the Delphi study, with 47, 30 and 25 responding in rounds one, two and three, respectively. After three rounds, we achieved consensus on a set of 71 items separated into a set of 35 "common" items (relevant to all studies on measurement properties) and 41 "specific" items (exclusively relevant to one of the nine measurement properties)., Conclusion: Consensus was achieved on a set of 71 items for inclusion in a reporting guideline for studies on measurement properties of PROMs. These items will guide researchers on the necessary information to include in their reports of investigations of measurement properties of PROMs. This guideline will likely improve the completeness of reporting of these important studies., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: The Outcome measures for vascular malformation (OVAMA) group reached consensus on the core outcome domains for the core outcome set (COS) for peripheral vascular malformations (venous, lymphatic and arteriovenous malformations). However, it is unclear which instruments should be used to measure these domains. Therefore, our aims were to identify all outcome measurement instruments available for vascular malformations, and to evaluate their measurement properties., Methods: With the first literature search, we identified outcomes and instruments previously used in prospective studies on vascular malformations. A second search yielded studies on measurement properties of patient- and physician-reported instruments that were either developed for vascular malformations, or used in prospective studies. If the latter instruments were not specifically validated for vascular malformations, we performed a third search for studies on measurement properties in clinically similar diseases (vascular or lymphatic diseases and benign tumors). We assessed the methodological quality of these studies following the Consensus-based Standards for the selection of health Measurement Instruments methodology, and evaluated the quality of the measurement properties., Results: The first search yielded 27 studies, none using disease-specific instruments. The second and third search included 22 development and/or validation studies, concerning six instruments. Only the Lymphatic Malformation Function Instrument was developed specifically for vascular malformations. Other instruments were generic QoL instruments developed and/or partly validated for clinically similar diseases., Conclusions: Additional research on measurement properties is needed to assess which instruments may be included in the COS. This review informs the instrument selection and/or the development of new instruments., Systematic Review Registration: PROSPERO, 42017056242.

Purpose: To examine the responsiveness of the EQ-5D-3L and EQ-5D-5L among total hip/knee replacement (THR/TKR) patients., Methods: The EQ-5D (3L or 5L) and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) have been routinely administered to all THR/TKR patients before and at 3 months after surgery in Alberta, Canada, since 2010. Patients were included in this analysis if they completed the WOMAC and the same version of EQ-5D at baseline and 3-month follow-up. The WOMAC was used as an anchor to categorize patients into 9 subgroups according to the relative change from baseline, i.e., no change, and 4 categories each for the amount of deterioration or improvement: large (≥ 70%), moderate (50% ≤ change < 70%), small but important (20% ≤ change < 50%), and very mild (0 < change ≤ 20%). The responsiveness of the EQ-5D-3L and EQ-5D-5L for each subgroup was assessed using effect size, standardized response mean, and Guyatt's Responsiveness Index., Results: A total of 1594 patients completed the EQ-5D-3L and WOMAC (60% females, mean age 66 years, N = 646 [41%] THR), and 3180 completed the EQ-5D-5L and WOMAC (60% females, mean age 66 years, N = 1352 [43.2%] THR) at baseline and 3-month follow-up. For both THR and TKR patients with "small but important" improvement, the EQ-5D-5L was consistently more responsive than the EQ-5D-3L., Conclusion: Our study demonstrated that the EQ-5D-5L is more responsive than the EQ-5D-3L in identifying health-related quality of life changes in THR/TKR patients. We recommend using the EQ-5D-5L in longitudinal studies in this patient population.

Purpose: The Depression Anxiety Stress Scales (DASS)-21 measures emotional symptoms of depression, anxiety, and stress, is relatively short, and is freely available in the public domain, which has resulted in it being applied to various clinical and non-clinical populations in many countries. The aim of this study was to systematically review the measurement properties of the DASS-21., Methods: The MEDLINE, Embase, and CINAHL databases were searched. The methodological quality of each identified study was assessed using the updated COSMIN Risk of Bias checklist. The quality of the measurement properties of the studies was rated using the updated criteria for good measurement properties. The quality of evidence was rated using a modified version of the GRADE approach., Results: This study included 48 studies in its review. The content validity of the DASS-21 demonstrated sufficient moderate-quality evidence. The instrument exhibited sufficient high-quality evidence for bifactor structural validity and internal consistency. The instrument also showed sufficient high-quality evidence for hypothesis testing of construct validity. Regarding criterion validity, only the DASS-21 Depression subscale demonstrated sufficient high-quality evidence. The measurement invariance across gender demonstrated inconsistent moderate-quality evidence. There was insufficient low-quality evidence for the reliability of each subscale. For responsiveness there was sufficient low-quality evidence for depression and stress subscales, and insufficient very-low-quality evidence for anxiety subscale., Conclusions: The DASS-21 demonstrated sufficient high-quality evidence for bifactor structural validity, internal consistency (bifactor), criterion validity (Depression subscale), and hypothesis testing for construct validity. Further studies are required to assess the other measurement properties of the DASS-21.

Purpose: Patient-reported health-related quality of life is a complementary healthcare outcome and important when assessing treatment efficacy. Using COSMIN methodological recommendations, this study evaluates the validity and reliability of a core heart disease-specific health-related quality of life questionnaire, the HeartQoL questionnaire (Danish version) in a sample of patients following heart valve surgery., Design: This project involved a cross-sectional validity study and a test-retest reliability study., Methods: Eligible patients completed the HeartQoL, the SF-36 health survey questionnaire, and the Hospital Anxiety and Depression Scale following heart valve surgery. Construct validity was tested using a priori hypotheses. Internal consistency reliability was assessed with Cronbach's alpha. An independent sample of patients participated in the test-retest study and reproducibility was determined with relative [intra-class correlation coefficient (ICC)] and absolute reliability [standard error of measurement (SEM) and smallest detectable change (SDC)]., Results: Internal consistency was high with Cronbach's alpha ≥ 0.87. ICC was 0.86-0.92. SEM ranged from 0.17 to 0.26 points and SDC ranged from 0.5 to 0.7 points. Construct validity was confirmed with 87% of all a priori hypotheses for predicted variables., Conclusions: The HeartQoL questionnaire demonstrates acceptable construct validity, internal consistency, and test-retest reproducibility in patients following heart valve surgery. Future studies should focus on assessing the responsiveness of the HeartQoL questionnaire over time and following heart valve surgery.

Purpose: To conduct a systematic review on measurement properties of questionnaires measuring depressive symptoms in adult patients with type 1 or type 2 diabetes., Methods: A systematic review of the literature in MEDLINE, EMbase and PsycINFO was performed. Full text, original articles, published in any language up to October 2016 were included. Eligibility for inclusion was independently assessed by three reviewers who worked in pairs. Methodological quality of the studies was evaluated by two independent reviewers using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Quality of the questionnaires was rated per measurement property, based on the number and quality of the included studies and the reported results., Results: Of 6286 unique hits, 21 studies met our criteria evaluating nine different questionnaires in multiple settings and languages. The methodological quality of the included studies was variable for the different measurement properties: 9/15 studies scored 'good' or 'excellent' on internal consistency, 2/5 on reliability, 0/1 on content validity, 10/10 on structural validity, 8/11 on hypothesis testing, 1/5 on cross-cultural validity, and 4/9 on criterion validity. For the CES-D, there was strong evidence for good internal consistency, structural validity, and construct validity; moderate evidence for good criterion validity; and limited evidence for good cross-cultural validity. The PHQ-9 and WHO-5 also performed well on several measurement properties. However, the evidence for structural validity of the PHQ-9 was inconclusive. The WHO-5 was less extensively researched and originally not developed to measure depression., Conclusion: Currently, the CES-D is best supported for measuring depressive symptoms in diabetes patients.

Purpose: Systematic reviews of patient-reported outcome measures (PROMs) differ from reviews of interventions and diagnostic test accuracy studies and are complex. In fact, conducting a review of one or more PROMs comprises of multiple reviews (i.e., one review for each measurement property of each PROM). In the absence of guidance specifically designed for reviews on measurement properties, our aim was to develop a guideline for conducting systematic reviews of PROMs., Methods: Based on literature reviews and expert opinions, and in concordance with existing guidelines, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) steering committee developed a guideline for systematic reviews of PROMs., Results: A consecutive ten-step procedure for conducting a systematic review of PROMs is proposed. Steps 1-4 concern preparing and performing the literature search, and selecting relevant studies. Steps 5-8 concern the evaluation of the quality of the eligible studies, the measurement properties, and the interpretability and feasibility aspects. Steps 9 and 10 concern formulating recommendations and reporting the systematic review., Conclusions: The COSMIN guideline for systematic reviews of PROMs includes methodology to combine the methodological quality of studies on measurement properties with the quality of the PROM itself (i.e., its measurement properties). This enables reviewers to draw transparent conclusions and making evidence-based recommendations on the quality of PROMs, and supports the evidence-based selection of PROMs for use in research and in clinical practice.

Purpose: The original COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was developed to assess the methodological quality of single studies on measurement properties of Patient-Reported Outcome Measures (PROMs). Now it is our aim to adapt the COSMIN checklist and its four-point rating system into a version exclusively for use in systematic reviews of PROMs, aiming to assess risk of bias of studies on measurement properties., Methods: For each standard (i.e., a design requirement or preferred statistical method), it was discussed within the COSMIN steering committee if and how it should be adapted. The adapted checklist was pilot-tested to strengthen content validity in a systematic review on the quality of PROMs for patients with hand osteoarthritis., Results: Most important changes were the reordering of the measurement properties to be assessed in a systematic review of PROMs; the deletion of standards that concerned reporting issues and standards that not necessarily lead to biased results; the integration of standards on general requirements for studies on item response theory with standards for specific measurement properties; the recommendation to the review team to specify hypotheses for construct validity and responsiveness in advance, and subsequently the removal of the standards about formulating hypotheses; and the change in the labels of the four-point rating system., Conclusions: The COSMIN Risk of Bias checklist was developed exclusively for use in systematic reviews of PROMs to distinguish this application from other purposes of assessing the methodological quality of studies on measurement properties, such as guidance for designing or reporting a study on the measurement properties.

Purpose: This systematic review (1) identifies the current generic and cancer-related patient-reported outcome measures (PROMs) that have been cross-culturally adapted to Brazilian Portuguese and applied to cancer patients and (2) critically evaluates their cross-cultural adaptation (CCA) and measurement properties., Methods: Seven databases were searched for articles regarding the translation and evaluation of measurement properties of generic and cancer-related PROMs cross-culturally adapted to Brazilian Portuguese that are applied in adult (≥18 years old) cancer patients. The methodological quality of included studies was assessed using the COSMIN checklist., Results: The bibliographic search retrieved 1674 hits, of which seven studies analysing eight instruments were included in this review. Data on the interpretability of scores were poorly reported. Overall, the quality of the CCA process was inconsistent throughout the studies. None of the included studies performed a cross-cultural validation. The evidence concerning the quality of measurement properties is limited by poor or fair methodological quality. Moreover, limited information regarding measurement properties was provided within the included papers., Conclusions: This review aids the selection process of Brazilian Portuguese PROMs for use in cancer patients. After acknowledging the methodological caveats and strengths of each tool, our opinion is that for quality of life and symptoms assessment the adapted FACT-G version and the ESAS could be recommended, respectively. Future research should rely on the already accepted standards of CCA and validation studies.

The purpose of this study is to assess the measurement properties of EQ-5D-5L compared to EQ-5D-3L in psoriasis patients., Methods: A cross-sectional survey was carried out at an academic dermatology clinic in Hungary. Psoriasis patients completed the EQ-5D-3L, EQ-5D-5L and Dermatology Life Quality Index (DLQI) questionnaires, and Psoriasis Area and Severity Index (PASI) was assessed. The UK value sets were used to calculate the 3L and 5L index scores. We tested the feasibility, ceiling effect, redistribution properties, the level of inconsistency and informativity (Shannon and Shannon Evenness indices). Spearman's rank-order correlations were performed between EQ-5D, EQ VAS, DLQI and PASI scores. Known-groups validity was evaluated by comparing age groups, clinical subtypes and treatment groups., Results: Mean age of the 238 patients was 47 years, and 36.6% of them received biological therapy. Mean EQ-5D index score was 0.77 (SD: 0.26) with the 3L and 0.84 (SD: 0.19) with the 5L. The overall ceiling effect decreased from 37.1 (3L) to 32.9% (5L). Shannon index improved significantly for most dimensions, but Shannon Evenness index improved only in three dimensions. Compared to the 3L, the 5L version confirmed a better convergent validity with PASI, but not with the DLQI. Known-groups validity was equally demonstrated both for the 5L and 3L., Conclusions: The EQ-5D-5L seems to improve measurement properties by reducing ceiling effects, strengthening correlations with PASI and improving informativity. Follow-up studies are needed to test responsiveness and reliability in psoriasis.

Purpose: The systematic review of patient-reported outcome instruments can allow the selection of the most appropriate instrument for use in research and clinical practice. There has been no systematic review of the measurement properties of irritable bowel syndrome (IBS)-specific health-related quality-of-life (HRQOL) instruments. The purposes of this study were to identify all available instruments for measuring the IBS-specific HRQOL and to determine which is the most appropriate instrument to apply in clinical practice., Methods: A systematic review study was conducted. The MEDLINE, EMBASE, and CINAHL databases were searched. The methodological quality of the included studies was assessed using the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) checklist. The measurement property results of each study were assessed using Terwee's quality criteria., Results: Seven instruments were identified: The Irritable Bowel Syndrome-Quality of Life (IBS-QOL) instrument was the only one that had been analyzed in multiple studies, with each of the remaining six instruments only being analyzed in a single psychometric study. The IBS-QOL demonstrated moderate positive evidence for internal consistency and reliability and is the best instrument based on the currently available evidence., Conclusions: Even though the IBS-QOL is currently the best instrument, there is conflicting evidence for its underlying structural validity. The factor structure or dimensionality of the IBS-QOL needs to be elucidated further.

Background: Systematic reviews of outcome measurement instruments are important tools for the selection of instruments for research and clinical practice. Our aim was to assess the quality of systematic reviews of health-related outcome measurement instruments and to determine whether the quality has improved since our previous study in 2007., Methods: A systematic literature search was performed in MEDLINE and EMBASE between July 1, 2013, and June 19, 2014. The quality of the reviews was rated using a study-specific checklist., Results: A total of 102 reviews were included. In many reviews the search strategy was considered not comprehensive; in only 59 % of the reviews a search was performed in EMBASE and in about half of the reviews there was doubt about the comprehensiveness of the search terms used for type of measurement instruments and measurement properties. In 41 % of the reviews, compared to 30 % in our previous study, the methodological quality of the included studies was assessed. In 58 %, compared to 55 %, the quality of the included instruments was assessed. In 42 %, compared to 7 %, a data synthesis was performed in which the results from multiple studies on the same instrument were somehow combined., Conclusion: Despite a clear improvement in the quality of systematic reviews of outcome measurement instruments in comparison with our previous study in 2007, there is still room for improvement with regard to the search strategy, and especially the quality assessment of the included studies and the included instruments, and the data synthesis.