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Abstract 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.

AbstractIntroduction 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.

Abstract 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.

Abstract Background The ability to communicate is a prerequisite for participation in today’s society. To measure participation in adults with communication disorders, the Communicative Participation Item Bank (CPIB) was developed in 2006. Since then, several new PROMs have been developed to measure communication and the impact of communication disorders on participation. Moreover, the CPIB items do not all appear to be relevant to certain populations with communication problems and context of communicative participation is changing rapidly, given the increased use of digital communication forms. The purpose of this study was to identify new PROMs developed since 2006 that aim to measure (aspects of) communication, in order to select items that are suitable for expanding the Communicative Participation Item Bank to make the item bank more widely applicable (e.g., to the hearing-impaired population) and tailored to the current societal context. Methods Medline and Embase were used to search for PROMs that aim to measure (aspects of) communication. Each new PROM as well as the CPIB, was evaluated to determine to what extent it contains items that measure communicative participation and to what extent these items capture all communicative participation domains by linking each item to the ICF Activities and Participation domains. Results This study identified 31 new PROMs, containing 391 items that were labelled as measuring communicative participation. The majority of the 391 items measure aspects of ICF Activities and Participation domain ‘communication’, followed by the domain ‘interpersonal interactions and relationships’. The other ICF Activity and Participation domains were less often addressed. Analysis of the CPIB showed that items do not cover all domains of participation as defined in the ICF, such as the ‘major life areas’ domain. Conclusions We found a potential pool of 391 items measuring communicative participation that could be considered for extending the CPIB. We found items in domains that are already present in the CPIB, but also items that relate to new domains, such as an item on talking with customers or clients for the ‘major life areas’ domain. Inclusion of new items in other domains would benefit the comprehensiveness of the item bank.

Abstract Background The Patient-Reported Outcomes Measurement Information System (PROMIS®) has the potential to harmonize the measurement of health-related quality of life (HRQL) across medical conditions. We evaluated responsiveness and minimal important change (MIC) of seven Dutch-Flemish PROMIS computerized adaptive tests (CAT) in Dutch patients with advanced chronic kidney disease (CKD). Methods CKD patients (eGFR

Abstract Background Core outcome sets (COSs) aim to reduce outcome heterogeneity in clinical practice and research by suggesting a minimum number of agreed-upon outcomes in clinical trials. Most COSs in the musculoskeletal field are developed for specific conditions. We propose that there are likely to be common core domains within existing musculoskeletal COSs that may be used as a starting point in the development of future COSs. We aim to identify common core domains from existing COSs and to facilitate the development of new COSs for musculoskeletal conditions. As a secondary aim, we will assess the development quality of these COSs. Methods A systematic review including musculoskeletal COSs. We will search Core Outcome Measures in Effectiveness Trials (COMET) database, MEDLINE, EMBASE, Scopus, Cochrane Methodology Register and International Consortium for Health Outcome Measurement (ICHOM). Studies will be included if related to the development of a COS in adults with musculoskeletal conditions and for any type of intervention. Quality will be assessed using the Core Outcome Set-Standards for Development (COS-STAD) recommendations. Data extracted will include scope of the COS, health condition, interventions and outcome domains. Primary outcomes will be all core domains recommended within each COS. We define a common core outcome domain as one present in at least 67% of all COSs. All findings will be summarized and presented using descriptive statistics. Discussion This systematic review of COSs will describe the core domains recommended within each musculoskeletal COS. Common domains found may be used in the initial stages of development of future musculoskeletal COSs. Systematic review registration PROSPERO CRD42021239141

Abstract Background There is a lack of consensus related to the collection of standardized data for individuals with vitiligo enrolled in clinical trials and registries as well as those seen in clinical practice which causes difficulty in accurately interpreting, comparing, and pooling of data. Several years ago, efforts to initiate work on developing core outcome sets were performed and a consensus was reached in 2015 on the first core domain set for vitiligo clinical trials. Methods/design This project aims to further develop a core outcome set for vitiligo clinical trials as well as create internationally agreed-upon core outcome sets for registries and clinical practice. These core outcome sets will include a core domain set and a core measurement instruments set and will be supplemented by contextual factors, including baseline and treatment-related characteristics. In a preparatory exercise, the 2015 core domain set will be re-evaluated and will serve as the basis for the list of outcome domains used to initiate the consensus process. This project will consist of two parts. Part 1 will focus on the selection of a core domain set, or “what to measure” and contextual factors, for each setting based on electronic surveys (e-Delphi technique) and a conclusive consensus meeting by a large group of international stakeholders. Part 2 will include selection of core measurement instruments, or “how to measure,” and measurement details (e.g., scale and timing) for the core domain sets and contextual factors agreed upon in part 1. Part 2 will be based on consensus meetings with stakeholders involved in part 1 and will be guided by C3 (CHORD-COUSIN Collaboration), Harmonising Outcome Measures for Eczema (HOME), COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), and Outcome Measures in Rheumatology (OMERACT) recommendations including information on measurement properties of available instruments (systematic review and expert/patient opinion). At the end of part 2, all stakeholders involved will be invited to participate in a final meeting in which the ultimate core data sets (core outcome sets and contextual factors) will be presented and the dissemination plan and implementation goals will be defined. Discussion This project will harmonize data collection between clinical trials, registries, and clinical practices, facilitating new insights in vitiligo. Trial registration This study is registered in the Core Outcome Measures for Effectiveness Trials (COMET) database and on the C3 (CHORD-COUSIN Collaboration) website.

Abstract Background Systematic reviews of outcome measurement instruments are important tools in the evidence-based selection of these instruments. COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) has developed a comprehensive and widespread guideline to conduct systematic reviews of outcome measurement instruments, but key information is often missing in published reviews. This hinders the appraisal of the quality of outcome measurement instruments, impacts the decisions of knowledge users regarding their appropriateness, and compromises reproducibility and interpretability of the reviews’ findings. To facilitate sufficient, transparent, and consistent reporting of systematic reviews of outcome measurement instruments, an extension of the PRISMA (Preferred Reporting of Items for Systematic reviews and Meta-Analyses) 2020 guideline will be developed: the PRISMA-COSMIN guideline. Methods The PRISMA-COSMIN guideline will be developed in accordance with recommendations for reporting guideline development from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network. First, a candidate reporting item list will be created through an environmental literature scan and expert consultations. Second, an international Delphi study will be conducted with systematic review authors, biostatisticians, epidemiologists, psychometricians/clinimetricians, reporting guideline developers, journal editors as well as patients, caregivers, and members of the public. Delphi panelists will rate candidate items for inclusion on a 5-point scale, suggest additional candidate items, and give feedback on item wording and comprehensibility. Third, the draft PRISMA-COSMIN guideline and user manual will be iteratively piloted by applying it to systematic reviews in several disease areas to assess its relevance, comprehensiveness, and comprehensibility, along with usability and user satisfaction. Fourth, a consensus meeting will be held to finalize the PRISMA-COSMIN guideline through roundtable discussions and voting. Last, a user manual will be developed and the final PRISMA-COSMIN guideline will be disseminated through publications, conferences, newsletters, and relevant websites. Additionally, relevant journals and organizations will be invited to endorse and implement PRISMA-COSMIN. Throughout the project, evaluations will take place to identify barriers and facilitators of involving patient/public partners and employing a virtual process. Discussion The PRISMA-COSMIN guideline will ensure that the reports of systematic reviews of outcome measurement instruments are complete and informative, enhancing their reproducibility, ease of use, and uptake.

Abstract Background Everyday functioning is a clinically relevant concept in dementia, yet little is known about the clinical meaningfulness of scores on functional outcome measures. We aimed to establish clinically meaningful scoring categories for the Amsterdam Instrumental Activities of Daily Living Questionnaire (A-IADL-Q), representing no, mild, moderate and severe problems in daily functioning. Methods Informal caregivers (n = 6) of memory-clinic patients and clinicians (n = 13), including neurologists and nurse specialists, working at various memory clinics in The Netherlands. In focus groups, participants individually ranked nine summaries of fictional patients from least to most impairment in daily functioning. Then, they placed bookmarks to demarcate the thresholds for mild, moderate and severe problems. Individual bookmark placements were then discussed to reach consensus. Clinicians completed a survey in which they placed bookmarks, individually. Results While individual categorizations varied somewhat, caregivers and clinicians generally agreed on the thresholds, particularly about the distinction between ‘no’ and ‘mild’ problems. Score categories were no problems (T-score ≥ 60), mild problems (T-score 50–59), moderate problems (T-score 40–49), and severe problems in daily functioning (T-score

Abstract Background The International Consortium for Health Outcomes Measurement (ICHOM) develops condition-specific Standard Sets of outcomes to be measured in clinical practice for value-based healthcare evaluation. Standard Sets are developed by different working groups, which is inefficient and may lead to inconsistencies in selected PROs and PROMs. We aimed to identify common PROs across ICHOM Standard Sets and examined to what extend these PROs can be measured with a generic set of PROMs: the Patient-Reported Outcomes Measurement Information System (PROMIS®). Methods We extracted all PROs and recommended PROMs from 39 ICHOM Standard Sets. Similar PROs were categorized into unique PRO concepts. We examined which of these PRO concepts can be measured with PROMIS. Results A total of 307 PROs were identified in 39 ICHOM Standard Sets and 114 unique PROMs are recommended for measuring these PROs. The 307 PROs could be categorized into 22 unique PRO concepts. More than half (17/22) of these PRO concepts (covering about 75% of the PROs and 75% of the PROMs) can be measured with a PROMIS measure. Conclusion Considerable overlap was found in PROs across ICHOM Standard Sets, and large differences in terminology used and PROMs recommended, even for the same PROs. We recommend a more universal and standardized approach to the selection of PROs and PROMs. Such an approach, focusing on a set of core PROs for all patients, measured with a system like PROMIS, may provide more opportunities for patient-centered care and facilitate the uptake of Standard Sets in clinical practice.

Abstract Purpose To assess the psychometric properties of the Dutch-Flemish Patient-Reported Outcome Measurement Information System Scale v1.2 – Global Health (PROMIS-GH). Methods The PROMIS-GH (also referred to as PROMIS-10) was administered to 4370 persons from the Dutch general population. Unidimensionality (CFI ≥ 0.95; TLI ≥ 0.95; RMSEA ≤ 0.06; SRMR ≤ 0.08), local independence (residual correlations 0.30), model fit with the Graded Response Model (GRM, p 0.75), precision (total score information across the latent trait), measurement invariance (no Differential Item Functioning [DIF]), and cross-cultural validity (no DIF for language, Dutch vs. United States English) of its subscales, composed of four items each, Global Mental Health (GMH) and Global Physical Health (GPH), were assessed. Results Confirmatory factor analyses, on both subscales, revealed slight departures from unidimensionality for GMH (CFI = 0.98; TLI = 0.95, RMSEA = 0.22; SRMR = 0.04) and GPH (CFI = 0.99; TLI = 0.97; RMSEA = 0.12; SRMR = 0.03). Local independence, monotonicity, GRM model fit, internal consistency, precision and cross-cultural validity were supported. However, Global10 (emotional problems) showed misfit on the GMH subscale, while Global08 (fatigue) presented DIF for age. Conclusion The psychometric properties of the PROMIS-GH in the Dutch population were considered acceptable. Sufficient local independence, monotonicity, GRM fit, internal consistency, measurement invariance and cross-cultural validity were found. If future studies find similar results, structural validity of the GMH could be enhanced by improving or replacing Global10 (emotional problems).

Abstract Background To reduce the burden of completing Patient-Reported Outcome Measures (PROMs), PROMIS® Computerized Adaptive Tests (CATs) are being implemented in pediatric clinical practice. We aimed to develop recommendations for visual feedback options for PROMIS CATs on individual item and domain score level as an evidence-based feedback recommendation for PROMIS CATs is lacking. Methods Focus groups were held with clinicians who use the KLIK PROM portal. Literature-based feedback options were provided to initiate group discussion. Data was analyzed using thematic coding method. Additionally, a questionnaire was sent out to assess patients’ (12-18y) and parents’ (child 0-18y) preference for individual item feedback. Data was analyzed using descriptive statistics. Results Six focus groups were held (N = 28 clinicians). Regarding individual item feedback, showing the complete item bank, with only responses to administered items in traffic light colors was preferred. For domain scores, line graphs were preferred, including numerical (T-)scores, reference and cut-off lines, and traffic light colors. Separate graphs per domain, ranked in order of importance and harmonization of directionality (‘higher = better’) were considered important. Questionnaire results (N = 31 patients/N = 131 parents) showed that viewing their own item responses was preferred above receiving no item feedback by 58.1% of the patients and 77.1% of the parents. Conclusions Based on the outcomes and after discussion with the Dutch-Flemish PROMIS National Center, recommendations for PROMIS CAT feedback options were developed. PROMIS CATs can now be used in clinical practice to help clinicians monitor patient outcomes, while reducing the burden of completing PROMs for patients significantly.

Abstract Background To add context to the impact of medical conditions, it is important to interpret and compare health outcomes across studies and populations. We aimed to determine Dutch reference values for the Patient-Reported Outcomes Measurement Information System Scale v1.2 - Global Health (PROMIS-GH). Methods The PROMIS-GH, also referred to as PROMIS-10, was completed by 4370 Dutch persons, representative for the 2016 Dutch population. T-scores for the mental health (GMH) and physical health (GPH) subscales, and their shorter two-item subscales, were calculated for the entire population, age groups and gender. T-scores for GMH and GPH were compared to the US reference population, representative for the 2000 US general population. Interpretability thresholds for poor, fair, good, very good and excellent GPH and GMH were calculated based on T-scores of participants, which were categorized into five groups based on their response to item Global01. For each group the mean GPH and GMH T-score was calculated and the midpoint between two adjacent means was identified, resulting in thresholds. Thresholds based on the Dutch data were compared to US thresholds. Results The Dutch population had a GMH T-score of 44.7 and a GPH T-score of 45.2, both substantially worse than the US reference population T-score of 50. Lower T-scores were also found for age-range and gender subpopulations. Dutch GMH and GPH interpretability thresholds were mostly not substantially different compared to the US thresholds, although the Dutch threshold between fair and poor mental health was considerably higher (29 vs. 38). Conclusions This study reports reference values for the PROMIS-GH scale for the Dutch general population, including age-range and gender subpopulations. These reference values provide an important tool for healthcare professionals and researchers to better evaluate and interpret patient-reported mental health and physical health. Scores are notably worse than the US reference values. The exact reason for this remains subject for further research, although possibilities for the differences are discussed, including the presence of differential item functioning and the representativeness and recentness of the data.

Objective: To systematically describe the use and outcomes of Patient-Reported Outcomes Measurement Information System (PROMIS) measures in clinical studies in populations with stroke. Data Sources: A systematic search on the use of PROMIS measures in clinical stroke studies in 9 electronic databases. Study Selection: Studies had to be original, reporting on outcome data using PROMIS measures in populations with stroke (ischemic and/or hemorrhagic), from January 1st, 2007. Initially, 174 unique studies met the inclusion criteria. In 2 steps, titles, abstracts and full-text articles were screened for eligibility (2 authors independently). Data Extraction: From the selected articles, study characteristics, type of PROMIS measures, and its outcomes were extracted by 2 authors independently. The authors discussed their views to achieve consensus. A third author was consulted if necessary. Data Synthesis: In total, 27 studies (24,366 patients) were included, predominantly from the United States (22); most study populations were hospital-based (20); the number of patients ranged from 30-3283. In general, patients had no or mild symptoms (median modified Rankin scale 1). Two different generic PROMIS measures were reported (PROMIS Global Health, PROMIS 29) and 9 PROMIS measures focusing on specific domains (sleep, pain, physical functioning, self-efficacy, satisfaction with social roles, depression, anxiety, cognition, fatigue). These match the International Classification of Functioning, Disability, and Health (ICF) domains mentioned in the Core Set for Stroke. The measures were administered 1-55 months after stroke. Outcome data are provided. Pooling of data was not achieved because of a large variety in study characteristics (inclusion criteria, follow-up moments, data processing). Conclusions: The PROMIS measures in this review could be relevant from a patient's perspective, covering ICF core set domains for patients with stroke. The large variety in study characteristics hampers comparisons across populations. Many different outcome measures are used to report results of stroke rehabilitation studies.

Abstract Background One of the main aims of rehabilitation is to improve participation. Patient-Reported Outcomes Measurement Information System (PROMIS®) item banks ‘Ability to Participate in Social roles and Activities, (PROMIS-APS) and ‘Satisfaction with Social Roles and Activities’ (PROMIS-SPS) are promising options to measure participation, but the literature on PROMIS measures of (satisfaction with) participation across diagnoses in rehabilitation is limited. Therefore, the objective of this study was to describe levels of and changes in participation, as assessed with the PROMIS-APS and the PROMIS-SPS short forms, of patients in outpatient rehabilitation. Methods This study had quantitative, observational design with assessments at admission and discharge. Consecutive patients treated between April and August 2018 receiving outpatient multidisciplinary rehabilitation were the population of this study. The following diagnosis categories were included: brain injury (e.g. stroke), spinal cord and nerve injury, neuromuscular disorder (e.g. lateral sclerosis), amputation, musculoskeletal condition (e.g. osteoarthritis) or heart or lung disease (e.g. myocardial infarction, chronic obstructive pulmonary disease). The main patient-reported outcomes (PRO) of this study were the short form of the PROMIS-APS (8 items, Dutch general population reference score 50.6 [SD 9.5]), and PROMIS-SPS (8 items, Dutch general population reference score 47.5 [SD 8.3]. Results Of the 1279 patients invited, 777 (61%) completed the online forms at admission. Of those, 329 patients were invited at discharge, with 209 (64%) completing the forms. The mean (SD) T-scores of the PROMIS-APS and PROMIS-SPS were lower at admission (42.7 [SD 7.4]; (41.4 [SD 7.7]) and discharge (43.6 [SD 7.2]; (43.7 [SD 7.8]) than the Dutch general population. The change scores of the PROMIS-APS and PROMIS-SPS were 1.2 (95% CI 0.4–1.9; p = 0.004; effect size 0.16), and 2.4 (95% CI 1.6–3.2; p 30 paired measurements statistically significant improvements of PROMIS-APS, PROMIS-SPS or both were seen. Conclusions Patients undergoing outpatient rehabilitation had, both at admission and discharge, considerably lower PROMIS-APS and PROMIS-SPS T-scores short forms than the general Dutch population, and showed small T-score improvements at discharge.

Introduction The outcomes anxiety and depression are measured frequently by healthcare providers to assess the impact of a disease, but with numerous instruments. PROMIS item banks provide an opportunity for standardized measurement. Cross-cultural validity of measures and the availability of reference values are prerequisites for standardized measurement. Methods PROMIS Anxiety and Depression item banks were completed by 1002 representative Dutch persons. To evaluate cross-cultural validity, data from US participants in PROMIS wave 1 were used and differential item functioning (DIF) was investigated, using an iterative hybrid of logistic regression and item response theory. McFadden’s pseudo R2-change of 2% was the critical threshold. The impact of any DIF on full item banks and short forms was investigated. To obtain Dutch reference values, T-scores for anxiety and depression were calculated for the complete Dutch sample, and age-group and gender subpopulations. Thresholds corresponding to normal limits, mild, moderate and severe symptoms were computed. Results In both item banks, two items had DIF but with minimal impact on population level T-scores for full item banks and short forms. The Dutch general population had a T-score of 49.9 for anxiety and 49.6 for depression, similar to the T-scores of 50.0 of the US general population. T-scores for age-group and gender subpopulations were also similar to T-scores of the US general population. Thresholds for mild, moderate and severe anxiety and depression were set to 55, 60 and 70, identical to US thresholds. Conclusions The limited number of items with DIF and its minimal impact, enables the use of standard (US) item parameters and comparisons of scores between Dutch and US populations. The Dutch reference values provide an important tool for healthcare professionals and researchers to evaluate and interpret symptoms of anxiety and depression, stimulating the uptake of PROMIS measures, and contributing to standardized outcome measurement.

Abstract Background Patient reported outcomes (PROs) provide information on a patient’s health status coming directly from the patient. Measuring PROs with patient reported outcome measures (PROMs) has gained wide interest in clinical practice for individual patient care, as well as in quality improvement, and for providing transparency of outcomes to stakeholders through public reporting. However, current knowledge of selecting and implementing PROMs for these purposes is scattered, and not readily available for clinicians and quality managers in healthcare organizations. The objective of this study is to develop a framework with tools to support the systematic selection, implementation and evaluation of PROs and PROMs in individual patient care, for quality improvement and public reporting. Methods We developed the framework in a national project in the Netherlands following a user-centered design. The development process of the framework contained five iterative components: (a) identification of existing tools, (b) identification of user requirements and designing steps for selection and implementation of PROs and PROMs, (c) discussing a prototype of the framework during a national workshop, (d) developing a web version, (e) pre-testing of the framework. A total of 40 users with different perspectives (clinicians, patient representatives, quality managers, purchasers, researchers) have been consulted. Results The final framework is presented as the PROM-cycle that consists of eight steps in four phases: (1) goal setting, (2) selecting PROs and PROMs, (3) developing and testing of quality indicator(s), (4) implementing and evaluating the PROM(s) and indicator(s). Users emphasized that the first step is the key element in which the why, for whom and setting of the PROM has to be defined. This information is decisive for the following steps. For each step the PROM-cycle provides guidance and tools, with instruments, checklists, methods, handbooks, and standards supporting the process. Conclusion We developed a framework to support the selection and implementation of PROs and PROMs. Each step provides guidance and tools to support the process. The PROM-cycle and its tools are publicly available and can be used by clinicians, quality managers, patient representatives and other experts involved in using PROMS. Through periodic evaluation and updates, tools will be added for national and international use of the PROM-cycle.

Abstract Background Inadequate and poor quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize, and build upon study findings and impacts evidence-based decision-making by patients, clinicians, and policy-makers. To facilitate harmonized and transparent reporting of outcomes in trial protocols and published reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is being developed. The final product will provide unique InsPECT extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines. Methods The InsPECT SPIRIT and CONSORT extensions will be developed in accordance with the methodological framework created by the EQUATOR (Enhancing the Quality and Transparency of Health Research Quality) Network for reporting guideline development. Development will consist of (1) the creation of an initial list of candidate outcome reporting items synthesized from expert consultations and a scoping review of existing guidance for reporting outcomes in trial protocols and reports; (2) a three-round international Delphi study to identify additional candidate items and assess candidate item importance on a 9-point Likert scale, completed by stakeholders such as trial report and protocol authors, systematic review authors, biostatisticians and epidemiologists, reporting guideline developers, clinicians, journal editors, and research ethics board representatives; and (3) an in-person expert consensus meeting to finalize the set of essential outcome reporting items for trial protocols and reports, respectively. The consensus meeting discussions will be independently facilitated and informed by the empirical evidence identified in the primary literature and through the opinions (aggregate rankings and comments) collected via the Delphi study. An integrated knowledge translation approach will be used throughout InsPECT development to facilitate implementation and dissemination, in addition to standard post-development activities. Discussion InsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes.

Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit the examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area. Methods: This study will examine late phase trials, published between October 2019 and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists’ awareness of, and decisions to search for and use a COS. Discussion: This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials.

Abstract Background To assess the construct validity and responsiveness of the PROMIS Physical Function v1.2 short form 8b (PROMIS-PF), and the PROMIS Ability to Participate in Social Roles and Activities v2.0 short form 8a (PROMIS-APS) in postoperative recovery. Methods An observational pilot study was conducted in which 30 patients participated, undergoing various forms of abdominal surgery. Patients completed the PROMIS-PF and PROMIS-APS, the Short Form 36 Health Survey (SF-36) and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) at several time points before and after surgery. The construct validity and responsiveness of the two PROMIS short forms were evaluated by testing pre-defined hypotheses and were considered adequate when at least 75% of the data was consistent with the hypotheses. Construct validity was evaluated by calculating Spearman correlations and the responsiveness by calculating effect sizes. Results 6/7 (85.7%) of the results were consistent with the hypotheses supporting the construct validity of the PROMIS-PF. For the PROMIS-APS this was the case in 7/15 (46.7%) of the results. For the PROMIS-PF, 6/7 (85.7%) of the results were consistent with the hypotheses, supporting responsiveness. Regarding the responsiveness of the PROMIS-APS, only 7 out of 13 (53.8%) of these results were consistent with the hypotheses. Conclusions This study supported the construct validity and the responsiveness of the PROMIS-PF v1.2 short form 8b for measuring recovery in abdominal surgery. Considering the major advantages of PROMIS, we recommend the use of the PROMIS-PF in abdominal surgery.

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.

Abstract The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified.

Abstract Introduction Detecting functional decline from normal aging to dementia is relevant for diagnostic and prognostic purposes. Therefore, the Amsterdam IADL Questionnaire (A‐IADL‐Q) was developed: a 70‐item proxy‐based tool with good psychometric properties. We aimed to design a short version while preserving its psychometric quality. Methods Study partners of subjects (n = 1355), ranging from cognitively normal to dementia subjects, completed the original A‐IADL‐Q. We selected the short version items using a stepwise procedure combining missing data, Item Response Theory, and input from respondents and experts. We investigated internal consistency of the short version and concordance with the original version. To assess its construct validity, we additionally investigated concordance between the short version and the Mini–Mental State Examination (MMSE) and Disability Assessment for Dementia (DAD). Finally, we investigated differences in instrumental activities of daily living (IADL) scores between diagnostic groups across the dementia spectrum. Results We selected 30 items covering the entire spectrum of IADL functioning. Internal consistency (0.98) and concordance with the original version (0.97) were very high. Concordance with the MMSE (0.72) and DAD (0.87) scores was high. IADL impairment scores increased across the spectrum from normal cognition to dementia. Discussion The A‐IADL‐Q short version (A‐IADL‐Q‐SV) consists of 30 items and has maintained the psychometric quality of the original A‐IADL‐Q. As such, the A‐IADL‐Q‐SV is a concise measure of functional decline.

Table of contents S1 Criteria for exercises selection in subjects with low back pain Alessandro Aina S2 Recent advances in pathophysiology and treatment of myofascial trigger points Marco Barbero S3 Rehabilitation of scapular dyskinesia Barbara Cagnie S4 Musculoskeletal rehabilitation in subjects affected by neurological disorders Elena Castelli S5 Which examination tests suggest the best candidates for manual therapy Chad Cook S6 Case study: the role of the measurements for the identification of targets and guidance of the treatment Silvano Ferrari S7 Assessment of joint mobility: state of the art Andrea Foglia, Paolo Bizzarri S8 Core stabilization exercises in the treatment of urinary incontinence Donatella Giraudo S9 Preventing surgical subacromial decompression through rotator cuff rehabilitation Chris Littlewood S10 Methodological aspects of Clinical Prediction Rules in the rehabilitation of Low Back Pain Paolo Pillastrini S11 Interpretability of outcome measures in musculoskeletal rehabilitation Daniele Piscitelli S12 Conservative treatment of the misalignment of the spine: state of the art and perspectives Michele Romano S13 Balance training in subjects with musculoskeletal disorders Andrea Tettamanti S14 Dosage of manual therapy: principles for clinical practice Carla Vanti S15 Are there speed limits in post-surgery lower limb rehabilitation? Stefano Vercelli S16 Classification of predominant neuropathic, nociceptive or central sensation pain Lennard Voogt P1 A wearable proprioceptive stabilizer (Equistasi®) for rehabilitation of balance disorders in multiple sclerosis patients: preliminary results of a randomized, double-blind, versus placebo controlled study Aceto Maria, Spina Emanuele, Paone Paolo, Silvestre Francesco, Carotenuto Antonio, Cerillo Ilaria, Orefice Giuseppe P2 Effect of repeated neck retraction movements on strength and EMG activity of the upper limbs, range of motion and cervical posture Bassi Raffaele, Fiorito Serena, Aina Alessandro P3 Hamstring injuries: clinical assessment or image evaluation? Bonfanti M., Pasquetti M. P4 Effectiveness of the physical therapy treatment on pelvic floor muscles in pelvic girdle pain. A literature review Bortolami Arianna, Pillastrini Paolo, Vanti Carla P5 Scapulo-humeral muscles electromiographic activity during the elevation movement of the upper limb in subjects with rotator cuff lesion Brioschi D, Vitali M, Pedretti A, Fraschini G, Tettamanti A P6 Mechanical low back pain: secular trend and intervention topics of randomized controlled trials Castellini G, Gianola S, Bonovas S, Banfi G, Moja L P7 Quality of reporting in rehabilitation interventions for low back pain: a review of published randomised controlled trials Greta Castellini, Silvia Gianola, Pamela Frigerio, Michela Agostini, Rosa Bolotta, Davide Corbetta, Monica Gasparini, Paolo Gozzer, Erica Guariento, Linda Li, Valentina Pecoraro, Valeria Sirtori, Andrea Turolla, Andreano A, Lorenzo Moja P8 Power analysis and sample size reporting in rehabilitation of low back pain: review of randomized controlled trials included in Cochrane systematic review Castellini G, Gianola S, Bonovas S, Moja L P9 A core outcome set for clinical trials in non-specific low back pain Alessandro Chiarotto, Caroline B. Terwee, Maarten Boers, Raymond W. Ostelo P10 Roland & Morris Disability Questionnaire and Oswestry Disability Index: which has better measurement properties? A systematic review and meta-analysis Alessandro Chiarotto, Lara J. Maxwell, Caroline B. Terwee, George A. Wells, Peter Tugwell, Raymond W. Ostelo P11 Prevalence of myofascial trigger points in spinal pain disorders: systematic review and meta-analysis Alessandro Chiarotto, Ron Clijsen, Cesar Fernandez-de-las-Penas, Marco Barbero P12 Post-surgical scar rating scales in physiotherapy: a systematic review Ciceri Matteo, Rossetti Sara, Vercelli Stefano P13 Efficacy of action observation pre-operative training in functional recovery after hip and knee prosthesis Cislaghi M, Penone G, Marinelli G, Rezzan G, Melegati G, Gatti R P14 The use of Kinesio Taping in the treatment of hematomas: can we distinguish fancy from the effects? Colombo Claudio, Tolosa Francesca, Andrea Moriondo, Vercelli Stefano P15 Who is able to perform explicit motor imagery after stroke? Stefano Doronzio, Matteo Paci P16 Responsiveness of the Bridge tests in Symptomatic Lumbar Spondylolisthesis Silvano Ferrari, Carla Vanti, Marco Monticone P17 The relationship between number of sessions and clinical results in lumbar symptomatic spondylolisthesis Silvano Ferrari, Carla Vanti, Marco Monticone P18 Conservative treatments for upper extremity tendinopathies in occupational medicine: narrative review Garzonio Fabiola, Zanetta Anna, Bargeri Serena, Cerone Giorgia, Sartorio Francesco P19 The time-related effect of roller-massager on extensibility of the hamstring muscles Filippo Ghirlanda, Alessandro Schneebeli, Corrado Cescon, Marco Barbero P20 Effect of two different exercise programs on pain, disability and quality of life in people with subacute and chronic nonspecific neck pain Gioia G, Faccendini S, Aina A, Tettamanti A P21 A bridge between clinical practice and research: how health professionals can study literature and learn on the job Granzotto G, Coppola L, Gava I, Frassinelli M, Gattinoni F P22 Walking capacity improves after neuromotor physiotherapy in stroke patients Lorenzo Guidotti, Marco Postiglione, Bruna Lombardi, Matteo Paci P23 Intra and inter-session reliability of the angle between pain onset and submaximal pain during upper limb neurodynamics test 1: a study in healty individuals Diego Leoni, Davide Storer, Roberto Gatti, Michele Egloff, Marco Barbero P24 Effects of an AO-MI training on balance task in patients affected by multiple sclerosis Magno Tiziano, Tettamanti Andrea P25 Outcomes of treatment with neuromuscular stimulator for chronic anterior knee pain: a clinical case Daniele Maremmani, Sebastiano Cencini, Giuseppe Plebani P26 Consistency in locating pressure stimuli over the lumbar spine on a digital body chart: a comparison between chronic low back pain patients and healthy subjects Federica Moresi, Marco Barbero, Matteo Isnardi, Alberto Gallace, Corrado Cescon, Roberto Gatti P27 Malignant Cord Compression in the thoraco-lumbar spine. Early signs and symptoms in the differential diagnosis of low back pain Moretti N, Maselli, Testa M. P28 End growth results of exercise treatment to avoid bracing in adolescents with idiopathic scoliosis: a prospective cohort controlled study Stefano Negrini, Sabrina Donzelli, Francesco Saveri, Alessandra Negrini, Silvana Parzini, Michele Romano, Fabio Zaina P29 Reliability of the Ashworth scale and its modified versions: systematic review and meta-analysis Leonardo Nesi, Francesco Ferrarello, Valeria Anna Maria Bianchi, Matteo Paci P30 Differences in motor recovery between upper and lower limbs in stroke subtypes Matteo Paci, Luca Nannetti, Bruna Lombardi P31 Influence of clinical experience on the reliability of the Salford Gait Tool Giuditta Mini, Mariangela Marchettini, Francesco Ferrarello, Matteo Paci P32 A somatosensory discrimination training induces brain functional changes in healthy young subjects Fabio Piccolo, Federica Agosta, Elisabetta Sarasso, Paola Adamo, Federico Temporiti, Andrea Falini, Roberto Gatti, Massimo Filippi P33 Effects of dynamic tilt-table with integrated robotic stepping associated with functional electrical stimulation: a cross-over study Daniele Piscitelli, Roberto Meroni, Leonardo Pellicciari, Marco A. Mondelli, Thomas Favaron, Cesare G. Cerri, Enrico A. Tallarita P34 Manual therapy techniques in the treatment of whiplash and its associated disorders: a systematic review Ravizzotti Elisa, Vercelli Stefano P35 The Patient and Observer Scar Assessment Scale (POSAS) as a screening tool for early detection of pathologic post-surgical scars in physiotherapy Rossetti Sara, Ciceri Matteo, Vercelli Stefano P36 The anatomical basis of genetic dystonia: a multimodal MRI study Elisabetta Sarasso, Federica Agosta, Aleksandra Tomić, Silvia Basaia, Nataša Dragašević, Marina Svetel, Massimiliano Copetti, Vladimir S. Kostic, Massimo Filippi P37 The relative inclination of the end vertebrae of a scoliotic single curve can influence the results of the conservative treatment? A pilot study Francesco Saveri, Michele Romano, Matteo Mastrantonio, Alessandra Negrini, Fabio Zaina, Negrini Stefano P38 Physiotherapy for myofascial pain syndromes: reported methodological quality of randomized controlled trials indexed in the PEDro database Alessandro Schneebeli, Greta Castellini, Valentina Redaelli, Emiliano Soldini, Marco Barbero P39 Is the patellar pubic percussion test useful to diagnose only femur fractures or something else? Two case reports Segat M, Casonato O, Margelli M, Pillon S. P40 Effectiveness of new rehab method for MDI Spunton V, Fenini R, Garofalo R, Conti M P41 Toe walking and autism: cross-sectional study on clinical presentation patterns and correlation with language delay Valagussa G, Balatti V, Trentin L, Melli S, Norsi M, and Grossi E P42 Active Kyphosis Value (AKV): a new test for the evaluation of the kyphotisation mobility of the thoracic spine Massimiliano Vanossi, Francesco Saveri, Michele Romano P43 Pain Drawing and psychological distress in low back pain - systematic review and meta-analysis Carla Vanti, Sara Taioli, Ivan Gardenghi, Lucia Bertozzi, Anna Rosso, Antonio Romeo, Paolo Pillastrini P44 Responsiveness of the Oswestry Disability Index in symptomatic lumbar spondylolisthesis Carla Vanti, Silvano Ferrari, Martina Ruggeri, Marco Monticone P45 The relationship between instability tests, pain and disability in non-specific low back pain Carla Vanti, Bellini Filippo, Cristina Conti, Federica Faresin, Martina Ruggeri, Raffaella Piccarreta, Silvano Ferrari P46 Smartphone applications (apps) for physical therapists: a review Villanova Luca, Vercelli Stefano P47 A randomized controlled pilot trial of hand robotic training compared with a sensory-motor training program in post stroke patients Violini Claudia, Cenci Marco Joseph, Delconte Carmen, Pisano Fabrizio P48 Critical Illness PolyNeuroMyopathy (CIPNM): chance for a good prognosis Youssef S, Montesano M, Picardi M, De Giampaulis P, Corbo M, Pisani L. P49 The EdUReP approach plus manual therapy for the management of insertional Achilles tendinopathy: a case study Zanetta Anna, Garzonio Fabiola, Ruella Carolina, Sartorio Francesco