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.

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.

Core Set of Patient-Reported Outcome Measures for Measuring Quality of Life in Clinical Obesity Care.

PURPOSE: The focus of measuring success in obesity treatment is shifting from weight loss to patients' health and quality of life. The objective of this study was to select a core set of patient-reported outcomes and patient-reported outcome measures to be used in clinical obesity care. MATERIALS AND METHODS: The Standardizing Quality of Life in Obesity Treatment III, face-to-face hybrid consensus meeting, including people living with obesity as well as healthcare providers, was held in Maastricht, the Netherlands, in 2022. It was preceded by two prior multinational consensus meetings and a systematic review. RESULTS: The meeting was attended by 27 participants, representing twelve countries from five continents. The participants included healthcare providers, such as surgeons, endocrinologists, dietitians, psychologists, researchers, and people living with obesity, most of whom were involved in patient representative networks. Three patient-reported outcome measures (patient-reported outcomes) were selected: the Impact of Weight on Quality of Life-Lite (self-esteem) measure, the BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), and the Quality of Life for Obesity Surgery questionnaire (excess skin). No patient-reported outcome measure was selected for stigma. CONCLUSION: A core set of patient-reported outcomes and patient-reported outcome measures for measuring quality of life in clinical obesity care is established incorporating patients' and experts' opinions. This set should be used as a minimum for measuring quality of life in routine clinical practice. It is essential that individual patient-reported outcome measure scores are shared with people living with obesity in order to enhance patient engagement and shared decision-making.

The minimal important change is not a universal fixed value across diagnoses when using the FAOS and FAAM in patients undergoing elective foot and ankle surgery.

PURPOSE: This study aimed to calculate region and diagnosis-specific minimal important changes (MICs) of the Foot and Ankle Outcome Score (FAOS) and the Foot and Ankle Ability Measure (FAAM) in patients requiring foot and ankle surgery and to assess their variability across different foot and ankle diagnoses. METHODS: The study used routinely collected data from patients undergoing elective foot and ankle surgery. Patients had been invited to complete the FAOS and FAAM preoperatively and at 3-6 months after surgery, along with two anchor questions encompassing change in pain and daily function. Patients were categorised according to region of pathology and subsequent diagnoses. MICs were calculated using predictive modelling (MICPRED) and receiver operating characteristic curve (MICROC) method and evaluated according to strict credibility criteria. RESULTS: Substantial variability of the MICs between forefoot and ankle/hindfoot region was observed, as well as among specific foot and ankle diagnoses, with MICPRED and MICROC values ranging from 7.8 to 25.5 points and 9.4 to 27.8, respectively. Despite differences between MICROC and MICPRED estimates, both calculation methods exhibited largely consistent patterns of variation across subgroups, with forefoot conditions systematically showing smaller MICs than ankle/hindfoot conditions. Most MICs demonstrated high credibility; however, the majority of the MICs for the FAOS symptoms subscale and forefoot conditions exhibited insufficient or low credibility. CONCLUSION: The MICs of the FAOS and FAAM vary across foot and ankle diagnoses in patients undergoing elective foot and ankle surgery and should not be used as a universal fixed value, but recognised as contextual parameters. This can help clinicians and researchers in more accurate interpretation of the FAOS and FAAM change scores. LEVEL OF EVIDENCE: Level IV.

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.

Enhancing the Evaluation of Physical Function Following Orthopaedic Trauma Care: Comparison of PROMIS Computerized Adaptive Testing and Short Musculoskeletal Function Assessment.

OBJECTIVES: To compare measurement properties of Patient-Reported Outcomes Measurement Information System (PROMIS) (physical function [PF] and pain interference [PI]) computerized adaptive testing to traditional Short Musculoskeletal Function Assessment (SMFA) (dysfunction index [DI] and bother index [BI]). To explore factors associated with PROMIS scores. DESIGN: Cross-sectional study. SETTING: Level I Trauma Center. PATIENT SELECTION CRITERIA: Isolated upper/lower extremity fracture patients were recruited from the orthopaedic trauma outpatient clinic (October 1, 2021 to January 1, 2023). OUTCOME MEASURES: Correlations (Pearson), reliability (standard error [SE] [T score]), efficiency (amount of information per item [1 - SE2/Nitems]), and floor/ceiling effects were assessed. An r > 0.7 represented high correlation, and SE ≤ 2.2 represented sufficient reliability. Factors associated with worse PROMIS scores were also identified. RESULTS: In total, 202 patients completed PROMs at median 98 days follow-up. Correlations between PROMIS-PF and SMFA-DI, and PROMIS-PI and SMFA-BI were -0.84 and 0.65. Reliability was very high for both instruments (mean SE 2.0 [PROMIS-PF], SE 2.1 [PROMIS-PI], and SE 1.2 [SMFA-DI], SE 1.8 [SMFA-BI]). Relative efficiency for PROMIS-PF versus SMFA-DI, and PROMIS-PI versus SMFA-BI was 7.8 (SD 2.5) and 4.1 (SD 1.7), respectively. Neither PROMIS nor SMFA exhibited floor/ceiling effects. In the multivariable regression analyses, elevated levels of depression, among other factors, showed an (independent) association with worse PROMIS-PF and PROMIS-PI scores. CONCLUSIONS: PROMIS-PF and PROMIS-PI CATs showed a (high and moderate) correlation with SMFA and hence measure a comparable construct of physical function and discomfort. As computerized adaptive tests are much more efficient to administer, they present a compelling alternative to SMFA for evaluating impact of fracture treatment. The relation between symptoms of depression and PROMIS scores emphasizes the importance of psychosocial aspects of health in orthopaedic trauma patients. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Extending the PROMIS item bank "ability to participate in social roles and activities": a psychometric evaluation using IRT.

OBJECTIVE: Our objective was to explore whether the extension of the PROMIS item bank Ability to Participate in Social Roles and Activities (APSRA) with new items would result in more effective targeting (i.e., selecting items that are appropriate for each individual's trait level), and more reliable measurements across all latent trait levels. METHODS: A sample of 1,022 Dutch adults completed all 35 items of the original item bank plus 17 new items (in Dutch). The new items presented in this publication have been translated provisionally from Dutch into English for presentation purposes. We evaluated the basic IRT assumptions unidimensionality, local independence, and monotonicity. Furthermore, we examined the item parameters, and assessed differential item functioning (DIF) for sex, education, region, age, and ethnicity. In addition, we compared the test information functions, item parameters, and θ scores, for the original and extended item bank in order to assess whether the measurement range had improved. RESULTS: We found that the extended item bank was compatible with the basic IRT assumptions and showed good reliability. Moreover, the extended item bank improved the measurement in the lower trait range, which is important for reliably assessing functioning in clinical populations (i.e., persons reporting lower levels of participation). CONCLUSION: We extended the PROMIS-APSRA item bank and improved its psychometric quality. Our study contributes to PROMIS measurement innovation, which allows for the addition of new items to existing item banks, without changing the interpretation of the scores and while maintaining the comparability of the scores with other PROMIS instruments.

Navigating the outcome maze: a scoping review of outcomes and instruments in clinical trials in genetic neurodevelopmental disorders and intellectual disability.

Background: Individuals with genetic neurodevelopmental disorders (GNDs) or intellectual disability (ID) are often affected by complex neuropsychiatric comorbidities. Targeted treatments are increasingly available, but due to the heterogeneity of these patient populations, choosing a key outcome and corresponding outcome measurement instrument remains challenging. Objectives: The aim of this scoping review was to describe the research on outcomes and instruments used in clinical trials in GNDs and ID. Eligibility criteria: Clinical trials in individuals with GNDs and ID for any intervention over the past 10 years were included in the review. Sources of evidence: MEDLINE, PsycINFO, and Cochrane CENTRAL were searched. Titles and abstracts were independently screened for eligibility with a subsample of 10% double-screening for interrater reliability. Data from full texts were independently reviewed. Discrepancies were discussed until consensus was reached. Charting methods: Information was recorded on patient populations, interventions, designs, outcomes, measurement instruments, and type of reporter when applicable. Qualitative and descriptive analyses were performed. Results: We included 312 studies reporting 91 different outcomes, with cognitive function most frequently measured (28%). Various outcome measurement instruments (n = 457) were used, with 288 in only a single clinical trial. There were 18 genetic condition-specific instruments and 16 measures were designed ad-hoc for one particular trial. Types of report included proxy-report (39%), self-report (22%), clinician-report (16%), observer-report (6%), self-assisted report (1%), or unknown (16%). Conclusion: This scoping review of current practice reveals a myriad of outcomes and outcome measurement instruments for clinical trials in GNDs and ID. This complicates generalization, evidence synthesis, and evaluation. It underlines the need for consensus on suitability, validity, and relevancy of instruments, ultimately resulting in a core outcome set. A series of steps is proposed to move from the myriad of measures to a more unified approach.

Navigating the maze of outcome measures in rare disorders Treatments for genetic neurodevelopmental disorders and intellectual disability are increasingly available. However, it is hard to find appropriate instruments to measure whether these treatments are working. This hampers research and means some patients might not get the treatment they need. This scoping review provides an overview of investigated outcomes in this group, and with which instruments these are measured. It reveals that many different and overlapping outcomes are measured, complicating gathering, combining, and comparing of evidence. This scoping review underlines the need for harmonization and consensus on suitability, validity, and relevancy. Steps are proposed to move from the maze of outcome measures to a unified approach. Also, we provided recommendations for researchers to measure what matters to affected individuals and patient-centered care.

The psychometric properties of the PROMIS® profile CAT in people with stroke.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System® (PROMIS) Profile Computer Adaptive Testing (CAT) consists of seven CATs and one single item measuring most relevant aspects of health-related quality of life (HRQoL). The aim of our study was to determine construct validity and floor and ceiling effects of the PROMIS Profile CAT in Dutch people with stroke. METHODS: People with stroke receiving rehabilitation completed the PROMIS Profile CAT and the EuroQol-5 dimensions (EQ5D). Construct validity was evaluated with hypotheses testing based on expected correlations between the profile domains and the domains of the EQ5D. The proportion of participants with the lowest and highest scores were calculated for each profile domain to assess floor and ceiling effects. RESULTS: 160 participants were included (median age 61 years, 41.9% female). For the PROMIS Profile domains Physical Function, Anxiety, Depression, Sleep Disturbance, Pain Interference, and Pain Intensity > 75% of the results met our hypotheses. For Fatigue and Ability to Participate in Social Roles and Activities only 60% of hypotheses were met. No floor or ceiling effects were found, with the exception of a floor effect for Pain Intensity which probably indicates that many participants had no pain. CONCLUSION: Most domains of the PROMIS Profile CAT showed sufficient construct validity and no problematic floor or ceiling effects in people with stroke. These CATs and the single item Pain Intensity can be used to efficiently measure HRQoL in people with stroke.

Identifying Relevant Concepts for the Development of a Communicative Participation Item Bank for Children and Adolescents: A Systematic Review of Existing Instruments.

PURPOSE: This study aims to systematically identify items that measure communicative participation from measurement instruments that measure (aspects of) communication and/or participation in children and adolescents (5-18 years old) with communication disorders, for developing an item bank. METHOD: A systematic literature search was performed in MEDLINE and Embase to search for patient-reported outcome measures (PROMs) or parent reports measuring aspects of communication and/or participation in children and adolescents. The individual items of the included measurement instruments were reviewed on whether they measure communicative participation. The items were then classified into one of the International Classification of Functioning, Disability and Health (ICF) for Children and Youth (World Health Organization, 2007) domains of activities and participation. RESULTS: A total of 29 instruments were found, nine PROMs and 20 parent reports. One hundred forty-five items were identified that measure communicative participation. From these 145 items, 74 were retrieved from PROMs (51%), and 71 were retrieved from parent reports (49%). The majority of items were classified in ICF Domain 7, interpersonal interactions and relationships (73.8%), followed by Domain 8, major life areas (13.8%), and Domain 9, community, social, and civic life (8.3%). Only a few items were found in Domains 5 and 6, and none was found in Domains 1, 2, and 4. CONCLUSIONS: We identified 145 items potentially useful for developing an item bank addressing communicative participation in children and adolescents with communication disorders. However, item development in collaboration with the target population is needed to ensure that these items fully reflect the construct.

What's in a score: A longitudinal investigation of scores based on item response theory and classical test theory for the Amsterdam Instrumental Activities of Daily Living Questionnaire in cognitively normal and impaired older adults.

OBJECTIVE: We aimed to investigate whether item response theory (IRT)-based scoring allows for a more accurate, responsive, and less biased assessment of everyday functioning than traditional classical test theory (CTT)-based scoring, as measured with the Amsterdam Instrumental Activities of Daily Living Questionnaire. METHOD: In this longitudinal multicenter study including cognitively normal and impaired individuals, we examined IRT-based and CTT-based score distributions and differences between diagnostic groups using linear regressions, and investigated scale attenuation. We compared change over time between scoring methods using linear mixed models with random intercepts and slopes for time. RESULTS: Two thousand two hundred ninety-four participants were included (66.6 ± 7.7 years, 54% female): n = 2,032 (89%) with normal cognition, n = 93 (4%) with subjective cognitive decline, n = 79 (3%) with mild cognitive impairment, and n = 91 (4%) with dementia. At baseline, IRT-based and CTT-based scores were highly correlated (r = -0.92). IRT-based scores showed less scale attenuation than CTT-based scores. In a subsample of n = 1,145 (62%) who were followed for a mean of 1.3 (SD = 0.6) years, IRT-based scores declined significantly among cognitively normal individuals (unstandardized coefficient [B] = -0.15, 95% confidence interval, 95% CI [-0.28, -0.03], effect size = -0.02), whereas CTT-based scores did not (B = 0.20, 95% CI [-0.02, 0.41], effect size = 0.02). In the other diagnostic groups, effect sizes of change over time were similar. CONCLUSIONS: IRT-based scores were less affected by scale attenuation than CTT-based scores. With regard to responsiveness, IRT-based scores showed more signal than CTT-based scores in early disease stages, highlighting the IRT-based scores' superior suitability for use in preclinical populations. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Estimating anchor-based minimal important change using longitudinal confirmatory factor analysis.

PURPOSE: The minimal important change (MIC) is defined as the smallest within-individual change in a patient-reported outcome measure (PROM) that patients on average perceive as important. We describe a method to estimate this value based on longitudinal confirmatory factor analysis (LCFA). The method is evaluated and compared with a recently published method based on longitudinal item response theory (LIRT) in simulated and real data. We also examined the effect of sample size on bias and precision of the estimate. METHODS: We simulated 108 samples with various characteristics in which the true MIC was simulated as the mean of individual MICs, and estimated MICs based on LCFA and LIRT. Additionally, both MICs were estimated in existing PROMIS Pain Behavior data from 909 patients. In another set of 3888 simulated samples with sample sizes of 125, 250, 500, and 1000, we estimated LCFA-based MICs. RESULTS: The MIC was equally well recovered with the LCFA-method as using the LIRT-method, but the LCFA analyses were more than 50 times faster. In the Pain Behavior data (with higher scores indicating more pain behavior), an LCFA-based MIC for improvement was estimated to be 2.85 points (on a simple sum scale ranging 14-42), whereas the LIRT-based MIC was estimated to be 2.60. The sample size simulations showed that smaller sample sizes decreased the precision of the LCFA-based MIC and increased the risk of model non-convergence. CONCLUSION: The MIC can accurately be estimated using LCFA, but sample sizes need to be preferably greater than 125.

Core outcome measurement instruments for use in clinical and research settings for adults with post-COVID-19 condition: an international Delphi consensus study.

Post-COVID-19 condition (also known as long COVID) is a new, complex, and poorly understood disorder. A core outcome set (COS) for post-COVID-19 condition in adults has been developed and agreement is now required on the most appropriate measurement instruments for these core outcomes. We conducted an international consensus study involving multidisciplinary experts and people with lived experience of long COVID. The study comprised a literature review to identify measurement instruments for the core outcomes, a three-round online modified Delphi process, and an online consensus meeting to generate a core outcome measurement set (COMS). 594 individuals from 58 countries participated. The number of potential instruments for the 12 core outcomes was reduced from 319 to 19. Consensus was reached for inclusion of the modified Medical Research Council Dyspnoea Scale for respiratory outcomes. Measures for two relevant outcomes from a previously published COS for acute COVID-19 were also included: time until death, for survival, and the Recovery Scale for COVID-19, for recovery. Instruments were suggested for consideration for the remaining nine core outcomes: fatigue or exhaustion, pain, post-exertion symptoms, work or occupational and study changes, and cardiovascular, nervous system, cognitive, mental health, and physical outcomes; however, consensus was not achieved for instruments for these outcomes. The recommended COMS and instruments for consideration provide a foundation for the evaluation of post-COVID-19 condition in adults, which should help to optimise clinical care and accelerate research worldwide. Further assessment of this COMS is warranted as new data emerge on existing and novel measurement instruments.

Common measures or common metrics? the value of IRT-based common metrics.

There is a clear need to harmonize outcome measurement. Some authors propose to express scores as T scores to facilitate interpretation of PROM results in clinical practice. While this is a step in the right direction, there are important limitations to the acceptance of the T score metric as a common metric when T scores are based on raw sum scores of ordinal items: Such T scores of different instruments are not exactly comparable because they are not interval scaled; T scores of different measures are only on the same scale if exactly the same reference group is used; and the T sore metric cannot be maintained because it is reference population-dependent and needs to be updated regularly. These limitations can be overcome by using an item response theory (IRT)-based metric. Items from different measures can be placed on the same IRT metric to make scores comparable on an interval scale. The PROMIS initiative used IRT to develop item banks for measuring various health outcomes. Other PROMs have been linked to the PROMIS metric. Although PROMIS uses a T-score metric for practical reasons, the underlying PROMIS metric is actually an IRT metric. An IRT approach also enables further development of an item bank while preserving the underlying metric. Therefore, IRT-based metrics should be considered as common metrics for the future.

Translation and cross-cultural adaptation of the ICHOM standard set for stroke: the Dutch version.

INTRODUCTION: The International Consortium for Health Outcomes Measurement (ICHOM) developed a standard set of patient-centered outcome measures for use in stroke patients. In addition to the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health, it is comprised of 25 questions that are not part of a specific questionnaire. This study aimed to translate these 25 single questions into Dutch. METHODS: Two native Dutch-speaking translators independently translated the original ICHOM questions into Dutch. A consensus translation was made by these translators and a third person. This translation was subsequently translated back to English independently by two native English-speaking translators. Afterwards a pre-final version was made by consensus of a committee. After field-testing among 30 stroke patients, a final version was made. RESULTS: The forward and backward translations led to eight cross-cultural adaptations. Based on the interviews with stroke patients, 12 questions were changed to enhance comprehensibility leading to a final Dutch translation of the 25 single questions. CONCLUSIONS: A Dutch translation of the 25 single questions of the ICHOM Standard Set for Stroke was developed. Now a complete ICHOM Standard Set for Stroke can be used in Dutch populations allowing comparison and improvement of stroke care.

Clinician-reported outcome measures for the assessment of vitiligo: A scoping review.

Clinician-reported outcome measures (ClinROMs) are essential for assessment of vitiligo in clinical trials and daily practice. Several instruments have been developed and tested to measure, for example, vitiligo extent, repigmentation and activity. The goal of this review was to identify all introductory publications of ClinROMs for vitiligo that include at least some aspects of validation and to describe the instruments' characteristics, intention for use and practical strengths and limitations. A search strategy was conducted in PubMed, Embase and Cochrane Library (CENTRAL) from inception to July 2022. Based on the literature search (n = 2860), 10 articles were identified, describing 14 different ClinROMs. Six ClinRoms measured disease extent and/or repigmentation, seven evaluated disease activity and one was a composite score. The Vitiligo Area Scoring Index (VASI), and Vitiligo Extent Score (VES and VESplus) measure overall disease extent and/or repigmentation. The VASI relies on hand units (1% body surface area), whereas the VES and VESplus use a picture-based scoring technique. The Vitiligo Extent Score for a Target Area (VESTA) measures repigmentation percentage for target lesions. One global assessment score for extent has been validated. Vitiligo disease activity scores included a static measure of clinical activity signs (Vitiligo Signs of Activity Score [VSAS]) and two measures assessing dynamic evolution (Vitiligo Disease Activity Score [VDAS] and Vitiligo Disease Improvement Score [VDIS]). The Vitiligo European Task Force assessment tool (VETFa) is a composite score. Depending on the practical strengths and limitations as well as the research question and setting (clinical trials vs. daily practice), the choice of an appropriate ClinROM may differ. Fourteen ClinROMs in vitiligo were identified to measure vitiligo extent, repigmentation, and activity. Further research evaluating the validity, reliability, and responsiveness of each instrument and worldwide consensus on which instrument to use for a specific outcome (domain) is greatly needed.

Patient-reported outcomes for people with diabetes: what and how to measure? A narrative review.

Patient-reported outcomes (PROs) are valuable for shared decision making and research. Patient-reported outcome measures (PROMs) are questionnaires used to measure PROs, such as health-related quality of life (HRQL). Although core outcome sets for trials and clinical practice have been developed separately, they, as well as other initiatives, recommend different PROs and PROMs. In research and clinical practice, different PROMs are used (some generic, some disease-specific), which measure many different things. This is a threat to the validity of research and clinical findings in the field of diabetes. In this narrative review, we aim to provide recommendations for the selection of relevant PROs and psychometrically sound PROMs for people with diabetes for use in clinical practice and research. Based on a general conceptual framework of PROs, we suggest that relevant PROs to measure in people with diabetes are: disease-specific symptoms (e.g. worries about hypoglycaemia and diabetes distress), general symptoms (e.g. fatigue and depression), functional status, general health perceptions and overall quality of life. Generic PROMs such as the 36-Item Short Form Health Survey (SF-36), WHO Disability Assessment Schedule (WHODAS 2.0), or Patient-Reported Outcomes Measurement Information System (PROMIS) measures could be considered to measure commonly relevant PROs, supplemented with disease-specific PROMs where needed. However, none of the existing diabetes-specific PROM scales has been sufficiently validated, although the Diabetes Symptom Self-Care Inventory (DSSCI) for measuring diabetes-specific symptoms and the Diabetes Distress Scale (DDS) and Problem Areas in Diabetes (PAID) for measuring distress showed sufficient content validity. Standardisation and use of relevant PROs and psychometrically sound PROMs can help inform people with diabetes about the expected course of disease and treatment, for shared decision making, to monitor outcomes and to improve healthcare. We recommend further validation studies of diabetes-specific PROMs that have sufficient content validity for measuring disease-specific symptoms and consider generic item banks developed based on item response theory for measuring commonly relevant PROs.