OBJECTIVE: 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.
CONCLUSIONS: 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.

Rare neurological conditions (RNCs) encompass a variety of diseases that differ in progression and symptoms but typically include muscle weakness, sensory and balance impairment and difficulty with coordinating voluntary movement. This can limit overall physical activity, so interventions to address this are recommended. The aim of this study was to agree a core outcome measurement set for physical activity interventions in people living with RNCs. We followed established guidelines to develop core outcome sets. Broad ranging discussions in a series of stakeholder workshops led to the consensus that (1) physical well-being; (2) psychological well-being and (3) participation in day-to-day activities should be evaluated in interventions. Recommendations were further informed by a scoping review of physical activity interventions for people living with RNCs. Nearly 200 outcome measures were identified from the review with a specific focus on activities or functions (e.g, on lower limb function, ability to perform daily tasks) but limited consideration of participation based outcomes (e.g., social interaction, work and leisure). Follow on searches identified two instruments that matched the priority areas: the Oxford Participation and Activities Questionnaire and the Sources of Self-Efficacy for Physical Activity. We propose these scales as measures to assess outcomes that are particularly relevant to assess when evaluating physical activity interventions mong people with RNCs. Validation work across rare neurological conditions is now required to inform application of this core outcome set in future clinical trials to facilitate syntheses of results and meta-analyses.

Allogeneic hematopoietic stem cell transplantation (HSCT) is associated with increased treatment-related mortality, loss of physical vitality, and impaired quality of life. Future research will investigate the effects of multidisciplinary rehabilitative interventions in alleviating these problems. Nevertheless, published studies in this field show considerable heterogeneity in selected outcomes and the outcome measurement instruments used. The purpose of this scoping review is to provide an overview of the outcomes and outcome measurement instruments used in studies examining the effects of rehabilitative interventions for patients treated with allogeneic HSCT.
We conducted a scoping review that included randomized controlled trials, pilot studies, and feasibility studies published up to 28 February 2022.
We included n = 39 studies, in which n = 84 different outcomes were used 227 times and n = 125 different instruments were used for the measurements.
Research in the field of rehabilitation for patients with haematological malignancies treated with allogeneic HSCT is hampered by the excess outcomes used, the inconsistent outcome terminology, and the inconsistent use of measurement instruments in terms of setting and timing. Researchers in this field should reach a consensus with regard to the use of a common terminology for the outcomes of interest and a homogeneity when selecting measurement instruments and measurement timing methods.

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.
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.
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.

BACKGROUND: Neurogenic bladder (NGB) is a chronic and disabling condition with a high prevalence rate, which can cause economic burden on patients and their families and reduce the quality of life of patients. Researchers have carried out a large number of clinical trials on the effectiveness and safety of different interventions for the treatment of NGB. The published clinical trials of NGB generally suffered from inconsistent and irregular reporting of outcome indicators. To facilitate future research studies of NGB, a core outcome set (COS) is required, which helps translate the results into high-quality evidence.
METHODS: This mixed-method project has four phases instrument: in phase 1, a scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of clinical trials of interventions for NGB; in phase 2, a qualitative component using interviews to obtain the views of NGB patients, families, and their caregivers; in phase 3, Delphi survey among stakeholders to prioritize the core outcomes; and in phase 4, a face-to-face consensus meeting to discuss and agree on the final NBG COS.
CONCLUSIONS: We will develop a COS that should be reported in future clinical trials of NGB.
BACKGROUND: Core Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: http://www.comet-initiative.org/studies/details/1985 . Registered on 02 January 2022. INPLASY  INPLASY202210007.

Research interest in Hidradenitis Suppurativa (HS) has grown exponentially over the past decades. Several groups have worked to develop novel scores that address the drawbacks of existing investigator-assessed and patient-reported outcome measures currently used in HS trials, clinical practice and research. In clinical trial settings, the drawbacks of the HiSCR have become apparent; mainly, it is lack of a dynamic measurement of draining tunnels. The newly developed (dichotomous) IHS4 and HASI-R are backed up by adequate validation data and are good contenders to become the new primary outcome measure in HS clinical trials. Patient-reported outcomes, as well as physician reported measures, are being developed by the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC). For example, the Hidradenitis Suppurativa Quality of Life (HiSQOL) score is a validated measure of HS-specific quality of life and is already being used in many HS trials. Magnitude of pain measurement via a 0-10 numerical rating scale is well-established; however, consensus is still required to ensure consistent administration and interpretation of the instrument. A longitudinal measurement over multiple days rather than at one time point, such as for example the Pain Index could provide increased reliability and reduced recall bias. Ultimately, these newly developed scores and tools can be included in a standardized registry to be used in routine clinical practice.

BACKGROUND: OMERACT uses an evidence-based framework known as the \'OMERACT Filter Instrument Selection Algorithm\' (OFISA) to guide decisions in the assessment of outcome measurement instruments for inclusion in a core outcome set for interventional and observational clinical trials.
METHODS: A group of OMERACT imaging and patient-centered outcome methodologists worked with imaging outcome groups to facilitate the selection of imaging outcome measurement instruments using the OFISA approach. The lessons learned from this work influenced the evolution to Filter 2.2 and necessitated changes to OMERACT\'s documentation and processes.
RESULTS: OMERACT has revised documentation and processes to incorporate the evolution of instrument selection to Filter 2.2. These revisions include creation of a template for detailed definitions of the target domain which is a necessary first step for instrument selection, modifications to the Summary of Measurement Properties (SOMP) table to account for sources of variability, and development of standardized reporting tables for each measurement property.
CONCLUSIONS: OMERACT Filter 2.2 represents additional modifications of the OMERACT guide for working groups in their rigorous assessment of measurement properties of instruments of various types, including imaging outcome measurement instruments. Enhanced reporting aims to increase the transparency of the evidence base leading to judgements for the endorsement of instruments in core outcome sets.

Imaging is one of the most rapidly evolving fields in medicine. Unfortunately, many imaging technologies have been applied as measurement instruments without rigorous evaluation of the evidence supporting their truth, discriminatory capability and feasibility for that context of use. The Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Instrument Selection Algorithm (OFISA) is used to evaluate such evidence for use of an instrument in a research setting. The objectives of this work are to: [1] define and describe the key conceptual aspects that are essential for the evaluation of imaging as an outcome measurement instrument and [2] describe how these aspects can be assessed through OFISA.
Experts in imaging and/or methodology met to formalize concepts and define key steps. These concepts were discussed with a team of patient research partners with interest in imaging to refine technical and methodological aspects into comprehensible information. A workshop was held at OMERACT2020 and feedback was incorporated into existing OMERACT process for domain and instrument selection.
Three key lessons were identified: (1) a clear definition of the domain we want to measure is a necessary prerequisite to the selection of a good instrument, (2) the sources of variability that can directly influence the instrument should be clearly identified, (3) incorporating these first two lessons into OFISA improves the quality of every instrument selection process.
The incorporation of these lessons in the updated OMERACT Filter (now 2.2) will improve the quality of the selection process for all types of outcome measurement instruments.

OBJECTIVE: Although neuropsychiatric involvement in Systemic Lupus Erythematosus (NPSLE) is one of the most complex and troubling manifestations of the disease, validated outcome instruments to be used as sensitive endpoints in controlled clinical trials are lacking. We set out a systematic literature review (SLR) to identify outcome measurement instruments and domains used to assess NPSLE.
METHODS: The Preferred Reporting Items for systematic reviews and Meta-analysis (PRISMA) guidelines were used. Articles available in English (1967-2020), listed in PubMed, EMBASE, PsycINFO, Cochrane Library and EULAR outcome measures library were screened. All domains and outcome measurement instruments were characterized according to the OMERACT Filter 2.1, considering core areas (manifestations/abnormalities, life impact, death/lifespan, societal/resource use) and contextual factors.
RESULTS: Of 3,392 abstracts evaluated, 83 studies were included in the SLR (15,974 patients, females 89.9%). Eligible studies included domains and instruments pertinent to all core areas defined by OMERACT, except for \"societal/resource use\". The most common core areas were \"manifestations/abnormalities\", covering 10 domains pertinent to laboratory and instrumental markers, indexes and neuropsychiatric dimension (cognitive, neurologic and psychiatric field), and \"life impact\", covering 7 domains related to physical function (from both the perspective of the patient and the physician), pain and quality of life.
CONCLUSIONS: Our study revealed great heterogeneity in the instruments derived from populations with NPSLE and none of these had high-quality evidence. This supports the need to develop and further validate a core domain set and outcome measurement instruments to promote clinical research in this field, enhancing comparability across studies.

Scores on an outcome measurement instrument depend on the type and settings of the instrument used, how instructions are given to patients, how professionals administer and score the instrument, etc. The impact of all these sources of variation on scores can be assessed in studies on reliability and measurement error, if properly designed and analyzed. The aim of this study was to develop standards to assess the quality of studies on reliability and measurement error of clinician-reported outcome measurement instruments, performance-based outcome measurement instrument, and laboratory values.
We conducted a 3-round Delphi study involving 52 panelists.
Consensus was reached on how a comprehensive research question can be deduced from the design of a reliability study to determine how the results of a study inform us about the quality of the outcome measurement instrument at issue. Consensus was reached on components of outcome measurement instruments, i.e. the potential sources of variation. Next, we reached consensus on standards on design requirements (n = 5), standards on preferred statistical methods for reliability (n = 3) and measurement error (n = 2), and their ratings on a four-point scale. There was one term for a component and one rating of one standard on which no consensus was reached, and therefore required a decision by the steering committee.
We developed a tool that enables researchers with and without thorough knowledge on measurement properties to assess the quality of a study on reliability and measurement error of outcome measurement instruments.