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Abstract Background Choosing an adequate measurement instrument depends on the proposed use of the instrument, the concept to be measured, the measurement properties (e.g. internal consistency, reproducibility, content and construct validity, responsiveness, and interpretability), the requirements, the burden for subjects, and costs of the available instruments. As far as measurement properties are concerned, there are no sufficiently specific standards for the evaluation of measurement properties of instruments to measure health status, and also no explicit criteria for what constitutes good measurement properties. In this paper we describe the protocol for the COSMIN study, the objective of which is to develop a checklist that contains COnsensus-based Standards for the selection of health Measurement INstruments, including explicit criteria for satisfying these standards. We will focus on evaluative health related patient-reported outcomes (HR-PROs), i.e. patient-reported health measurement instruments used in a longitudinal design as an outcome measure, excluding health care related PROs, such as satisfaction with care or adherence. The COSMIN standards will be made available in the form of an easily applicable checklist. Method An international Delphi study will be performed to reach consensus on which and how measurement properties should be assessed, and on criteria for good measurement properties. Two sources of input will be used for the Delphi study: (1) a systematic review of properties, standards and criteria of measurement properties found in systematic reviews of measurement instruments, and (2) an additional literature search of methodological articles presenting a comprehensive checklist of standards and criteria. The Delphi study will consist of four (written) Delphi rounds, with approximately 30 expert panel members with different backgrounds in clinical medicine, biostatistics, psychology, and epidemiology. The final checklist will subsequently be field-tested by assessing the inter-rater reproducibility of the checklist. Discussion Since the study will mainly be anonymous, problems that are commonly encountered in face-to-face group meetings, such as the dominance of certain persons in the communication process, will be avoided. By performing a Delphi study and involving many experts, the likelihood that the checklist will have sufficient credibility to be accepted and implemented will increase.

Aim In 2004, a model identifying children at risk of academic or behavioural limitations after bacterial meningitis ( BM) was presented. Risk factors were male gender, low birthweight, lower educational level of the father, Streptococcus pneumoniae, lower cerebrospinal fluid ( CSF) leucocyte count, delay between admission and start of antibiotics, dexamethasone <2 days, seizures and prolonged fever. The aim of this study was to validate that prediction model in an independent cohort. Methods Academic or behavioural limitations were determined in 93 Dutch school-age BM survivors. Risk factors for limitations were obtained from medical files. Validation was performed by applying the model in the cohort, then assessing discrimination and goodness of fit. Multiple imputation techniques were used to deal with missing values. Results Although fit of the model appeared good when it came to similarity of expected and observed cases (p-value of the Hosmer-Lemeshow test 0.24-0.57), discrimination was poor. Area under the curve ( AUC) of the receiver operated characteristics ( ROC) curve of the model was 0.83 (95% CI: 0.77-0.89) in the development cohort and 0.53 (95% CI: 0.41-0.65) in the validation cohort. Conclusion External validation of the model was unsuccessful. It is not suitable for implementation in practice. [ABSTRACT FROM AUTHOR]

STUDY DESIGN.: Systematic review of interventions. OBJECTIVE.: To assess the effects of spinal manipulative therapy (SMT) for acute low back pain. SUMMARY OF BACKGROUND DATA.: SMT is one of many therapies for the treatment of low back pain, which is a worldwide, extensively practiced intervention. METHODS.: An experienced librarian searched for randomized controlled trials (RCTs) in multiple databases up to March 13, 2011. RCTs that examined manipulation or mobilization in adults with acute low back pain (<6-week duration) were included. The primary outcomes were pain, functional status and perceived recovery. Secondary outcomes were return-to-work and quality of life. Two authors independently conducted the study selection, risk of bias assessment and data extraction. GRADE (grading of recommendations assessment, development, and evaluation) was used to assess the quality of the evidence. The effects were examined for SMT versus (1) inert interventions, (2) sham SMT, (3) other interventions, and (4) SMT as adjunct therapy. RESULTS.: We identified 20 RCTs (total participants = 2674), 12 (60%) of which were not included in the previous review. In total, 6 trials (30% of all included studies) had a low risk of bias. In general, for the outcomes of pain and functional status, there is low- to very low-quality evidence suggesting no difference in effect for SMT when compared with inert interventions, sham SMT or as adjunct therapy. There was varying quality of evidence (from very low to moderate) suggesting no difference in effect for SMT when compared with other interventions. Data were particularly sparse for recovery, return-to-work, quality of life, and costs of care. No serious complications were observed with SMT. CONCLUSION.: SMT is no more effective for acute low back pain than inert interventions, sham SMT or as adjunct therapy. SMT also seems to be no better than other recommended therapies. Our evaluation is limited by the few numbers of studies; therefore, future research is likely to have an important impact on these estimates. Future RCTs should examine specific subgroups and include an economic evaluation. [ABSTRACT FROM AUTHOR]

A critique of Hankins, M: 'How discriminating are discriminative instruments?' Health and Quality of Life Outcomes 2008, 6:36. [ABSTRACT FROM AUTHOR]

To investigate daily functioning, health-related quality of life (HRQoL), and overall quality of life (QoL) in young adult survivors of childhood bacterial meningitis (BM) thereby shedding light on very long-term outcomes and contributing to global meningitis burden estimates. In this cross-sectional study, the Weiss Functional Impairment Rating Scale-Self Report (WFIRS-S), the Patient-Reported Outcomes Measurement Information System Scale vGlobal Health v1.2 (PROMIS-GH), PROMIS-29 profile v2.01 and PROMIS Satisfaction with Social Roles and Activities Short Form 4a v2.0 instruments were administered to 483 survivors of childhood BM who participated in the 20|30 Dutch Postmeningitis study. Mean WFIRS-S scores were calculated as well as mean T-scores of the PROMIS instruments. PROMIS scores of survivors of childhood BM were compared with age-matched Dutch reference scores from the general population. Overall, survivors of childhood BM reported comparable or even better levels of daily functioning, HRQoL, and overall QoL (Global02) than the age-matched Dutch reference group. 10.2% of survivors of childhood BM reported poor mental health and 1.0% of survivors of childhood BM reported poor physical health. The average score of survivors of childhood BM for overall QoL (Global02) was 3.81 (on a scale from 1, indicating poor QoL, to 5, indicating excellent QoL)., Conclusion: Young adult survivors of childhood BM reported similar and even better levels of daily functioning, HRQoL, and overall QoL than age-matched Dutch reference scores. However, clinicians and healthcare workers should be mindful of poor mental and physical health of some survivors of childhood BM because these survivors also face problems with functioning in daily life., What Is Known: • Acute bacterial meningitis is a life-threatening infection which may lead to devastating lifelong disabilities. • Health-related quality of life is decreased in school-age survivors of bacterial meningitis., What Is New: • The present study shows that HRQoL in survivors of childhood BM improves over time • However, especially poor mental health in adolescent and young adult survivors is associated with impaired functioning in daily life., (© 2024. The Author(s).)

Background: People with communication problems experience challenges in participation. Optimizing communicative participation for this population is an important outcome of speech and language therapy. Participation experiences are best assessed from the patient's perspective, using a patient-reported outcome measure (PROM). The Communicative Participation Item Bank (CPIB) has been developed to identify perceived problems in communicative participation. However, previous research has shown that the item bank does not cover all domains and concepts of communicative participation, contains general communication items, and is not suitable for all people with communication problems., Aims: To develop a comprehensive PROM aimed at measuring communicative participation for all adults with communication problems and test its content validity., Methods & Procedures: An initial pool of 242 items was based on three sources: relevant content from an earlier literature review and concept elicitation study, and the translation of the items of the CPIB. This item pool was pilot-tested for comprehensibility and comprehensiveness using cognitive debriefing interviews in adults with different communication problems (speech, language, voice, hearing and cognitive communication disorders). This resulted in a second version of the item bank. The content validity of this version was tested in a group of professionals. The last (third) version of 133 items was tested for content validity in a second, new group of adults with various communication problems., Outcomes & Results: The initial pool of 242 items was developed and pilot-tested in 27 adults with different communication problems. After modifications, 161 items remained, which were tested in a content validity study with 25 people with different communication problems and five professionals (in the field of speech and language therapy and speech and language research). The professionals considered 91.9% of the item bank relevant and comprehensible, and comprehensive by adding two items. The item bank was then considered relevant, comprehensible and comprehensive by the group of adults with communication problems. A total of 133 items remained in the item bank, related to the International Classification of Functioning, Disability and Health (ICF) Activities and Participation domains 'mobility', 'self-care', 'domestic life', 'interpersonal interactions and relationships', 'major life areas' and 'community, social and civic life'., Conclusions & Implications: MyCommunication-Adults is an item bank for measuring communicative participation in adults with communication difficulties. The next step is to test the psychometric properties of the item bank, in order to establish a final item bank. The refined description of the construct of communicative participation can already be used for participation-focused goal-setting between individuals with communication problems and speech and language therapists., What This Paper Adds: What is already known on the subject The CPIB was developed to measure communicative participation in community-dwelling adults with communication problems. The item bank does not cover all domains and concepts of communicative participation, contains general communication items and not all questions seem to be relevant for specific target groups (e.g., hearing population). What this paper adds to the existing knowledge This study presents a refined description of the construct of communicative participation and the development of a new comprehensive PROM aimed at measuring this construct for all adults with communication difficulties. The development of the PROM is based on a previously conducted literature review and concept elicitation study. This study describes the development process of this new PROM, called MyCommunication-Adults, and the assessment of its content validity. What are the potential or actual clinical implications of this work? The refined description of the construct of communicative participation can be used for participation-focused goal-setting between individuals with communication problems and speech and language therapists., (© 2024 The Author(s). International Journal of Language & Communication Disorders published by John Wiley & Sons Ltd on behalf of Royal College of Speech and Language Therapists.)

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: The minimal important change (MIC) in a patient-reported outcome measure is often estimated using patient-reported transition ratings as anchor. However, transition ratings are often more heavily weighted by the follow-up state than by the baseline state, a phenomenon known as "present state bias" (PSB). It is unknown if and how PSB affects the estimation of MICs using various methods., Methods: We simulated 3240 samples in which the true MIC was simulated as the mean of individual MICs, and PSB was created by basing transition ratings on a "weighted change", differentially weighting baseline and follow-up states. In each sample we estimated MICs based on the following methods: mean change (MC), receiver operating characteristic (ROC) analysis, predictive modeling (PM), adjusted predictive modeling (APM), longitudinal item response theory (LIRT), and longitudinal confirmatory factor analysis (LCFA). The latter two MICs were estimated with and without constraints on the transition item slope parameters (LIRT) or factor loadings (LCFA)., Results: PSB did not affect MIC estimates based on MC, ROC, and PM but these methods were biased by other factors. PSB caused imprecision in the MIC estimates based on APM, LIRT and LCFA with constraints, if the degree of PSB was substantial. However, the unconstrained LIRT- and LCFA-based MICs recovered the true MIC without bias and with high precision, independent of the degree of PSB., Conclusion: We recommend the unconstrained LIRT- and LCFA-based MIC methods to estimate anchor-based MICs, irrespective of the degree of PSB. The APM-method is a feasible alternative if PSB is limited., (© 2024. The Author(s).)

Background: The commonly used ('legacy') PROMs evaluating outcomes of total hip arthroplasty (THA), have several limitations regarding their measurement properties and interpretation of scores. One innovation in PROMs is the use of Computerized Adaptive Testing (CAT). The Patient-Reported Outcomes Measurement Information System (PROMIS ® ) is a validated system of CATs. The aim of this study was to assess the measurement properties of PROMIS and legacy instruments in patients undergoing THA., Methodology: Patients in this multicenter study filled out a questionnaire twice, including Dutch-Flemish PROMIS v1.2 Physical Function (PROMIS-PF) and v1.1 Pain Interference (PROMIS-PI) CATs and short forms, PROMIS v1.0 Pain Intensity, and legacy PROMs (Hip disability and Osteoarthritis Outcome Score (HOOS), HOOS-Physical function Shortform (HOOS-PS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Oxford Hip Score (OHS), and two numeric rating scales measuring pain). The reliability, measurement precision (Standard Error of Measurement (SEM)), smallest detectable change (SDC), and burden of PROMIS instruments were presented head-to-head to legacy PROMs. Furthermore, construct validity was assessed., Results: 208 patients were included. All instruments had a sufficient test-retest reliability (range ICC: 0.83-0.96). The SEM of PROMIS CATs and short forms ranged from 1.8 to 2.2 T-score points, the SEM of legacy instruments 2.6-11.1. The SDC of PROMIS instruments ranged from 2.1 to 7.3 T-score points, the SDC of legacy instruments 7.2-30.9. The construct validity of PROMIS CAT and short forms were found sufficient, except for the PROMIS-PI short form. The burden of PROMIS CATs was smaller than PROMIS short forms (range 4.8-5.2 versus 8-20 items, respectively). The burden of legacy instruments measuring physical functioning ranged from 5 to 40 items., Conclusions: The PROMIS-PF is less burdensome, with high measurement precision, and almost no minimal or maximal scores, and an equal reliability compared to legacy instruments measuring physical functioning in patients undergoing THA. The PROMIS Pain Intensity 1a is comparable to the legacy pain instruments in terms of burden, reliability and SDC. Measuring the construct Pain Interference may not have additional value in this population because of its high correlation with instruments measuring physical functioning. The SDC values presented in this study can be used for individual patient monitoring., (© 2024. The Author(s).)

The lack of standardization in patient-reported outcome measures (PROMs) has made measurement and comparison of quality of life (QoL) outcomes in research focused on obesity treatment challenging. This study reports on the results of the second and third global multidisciplinary Standardizing Quality of life measures in Obesity Treatment (S.Q.O.T.) consensus meetings, where a core set of PROMs to measure nine previously selected patient-reported outcomes (PROs) in obesity treatment research was established. The S.Q.O.T. II online and S.Q.O.T. III face-to-face hybrid consensus meetings were held in October 2021 and May 2022. The meetings were led by an independent moderator specializing in PRO measurement. Nominal group techniques, Delphi exercises, and anonymous voting were used to select the most suitable PROMs by consensus. The meetings were attended by 28 and 27 participants, respectively, including a geographically diverse selection of people living with obesity (PLWO) and experts from various disciplines. Out of 24 PROs and 16 PROMs identified in the first S.Q.O.T. consensus meeting, the following nine PROs and three PROMs were selected via consensus: BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), IWQOL-Lite (self-esteem), and QOLOS (excess skin). No PROM was selected to measure stigma as existing PROMs deemed to be inadequate. A core set of PROMs to measure QoL in research focused on obesity treatment has been selected incorporating patients' and experts' opinions. This core set should serve as a minimum to use in obesity research studies and can be combined with clinical parameters., (© 2024 World Obesity Federation.)

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.

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).)

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 (MIC PRED ) and receiver operating characteristic curve (MIC ROC ) 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 MIC PRED and MIC ROC values ranging from 7.8 to 25.5 points and 9.4 to 27.8, respectively. Despite differences between MIC ROC and MIC PRED 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., (© 2024 European Society of Sports Traumatology, Knee Surgery and Arthroscopy.)

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., Competing Interests: Declaration of competing interest Drs Terwee and Mokkink are the founders of COSMIN; Dr Moher is a member of the PRISMA executive; Dr Tricco is the co-editor in chief of the Journal of Clinical Epidemiology. The other authors have no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

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., (© 2024. The Author(s).)

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., (© 2024. The Author(s).)

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., Competing Interests: The authors report no conflict of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

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., Competing Interests: The authors declare that there is no conflict of interest., (© The Author(s), 2024.)

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.

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., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

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).

Introduction: Patient-Reported Outcomes Measurement Information System (PROMIS ® ) is commonly used across medical conditions. To facilitate interpretation of scores across countries, we calculated Dutch reference values for PROMIS Physical Function (PROMIS-PF), Pain Interference (PROMIS-PI), Pain Behavior (PROMIS-PB), Ability to Participate in Social Roles and Activities (PROMIS-APSRA), and Satisfaction with Social Roles and Activities (PROMIS-SSRA), as compared to US reference values., Patients and Methods: A panel completed full PROMIS-PF ( n =1310), PROMIS-PI and PROMIS-PB ( n =1052), and PROMIS-APSRA and PROMIS-SSRA ( n =1002) item banks and reported their level of health per domain (no, mild, moderate, severe limitations). T-scores were calculated by sample and subgroups (age, gender, self-reported level of domain). Distribution-based and anchor-based thresholds for mild, moderate, and severe scores were determined., Results: Mean T-scores were close to the US mean of 50 for PROMIS-PF (49.8) and PROMIS-APSRA (50.6), lower for PROMIS-SSRA (47.5) and higher for PROMIS-PI (54.9) and PROMIS-PB (52.0). Distribution-based thresholds for mild, moderate, and severe scores were comparable to US recommended cut-off values (except for PROMIS-PI) but participants reported limitations 'earlier' than suggested thresholds., Conclusion: Dutch reference values were close to US reference values for some PROMIS domains but not all. We recommend country-specific reference values to facilitate worldwide PROMIS use.KEY MESSAGESPROMIS offers universally applicable IRT-based efficient and patient-friendly measures to assess commonly relevant patient-reported outcomes across medical conditions.To support the use of PROMIS in daily clinical practice and research across the world, country-specific general population reference values should be obtained.More research is necessary to obtain reliable and valid cut-off values for what constitutes mild, moderate and severe scores from the patients' perspective.