BACKGROUND: Since the COVID-19 pandemic, the use of video consultation (VC) in primary care has expanded considerably in many countries. VC and other telehealth formats are often touted as a solution to improved health care access, with numerous studies showing high satisfaction with this care format among health professionals and patients. However, operationalization and measurement of patient satisfaction with VC varies across studies and often lacks consideration of dynamic contextual factors (eg, convenience, ease-of-use, or privacy) and doctor-patient relational variables that may influence patient satisfaction.
OBJECTIVE: We aim to develop a comprehensive and evidence-based questionnaire for assessing patient satisfaction with VC in general practice.
METHODS: The vCare Patient-Satisfaction Questionnaire (the vCare-PSQ) was developed according to the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) guidelines. To achieve our overall objective, we pursued three aims: (1) a validation analysis of an existing patient-satisfaction scale (the PS-14), (2) an assessment of extrinsic contextual factors that may impact patient satisfaction, and (3) an assessment of pertinent intrinsic and relational satisfaction correlates (eg, health anxiety, information technology literacy, trust in the general practitioner, or convenience). For validation purposes, the questionnaire was filled out by a convenience sample of 188 Danish adults who had attended at least 1 VC.
RESULTS: Our validation analysis of the PS-14 in a Danish population produced reliable results, indicating that the PS-14 is an appropriate measure of patient satisfaction with VC in Danish patient populations. Regressing situational and doctor-patient relational factors onto patient satisfaction further suggested that patient satisfaction is contingent on several factors not measured by the PS-14. These include information technology literacy and patient trust in the general practitioner, as well as several contextual pros and cons.
CONCLUSIONS: Supplementing the PS-14 with dynamic measures of situational and doctor-patient relational factors may provide a more comprehensive understanding of patient satisfaction with VC. The vCare-PSQ may thus contribute to an enhanced methodological approach to assessing patient satisfaction with VC. We hope that the vCare-PSQ format may be useful for future research and implementation efforts regarding VC in a general practice setting.

BACKGROUND: Despite developing a polypharmacy core outcome set (COS) in primary care, it is not clear how these outcomes should be measured.
OBJECTIVE: To select outcome measurement instruments (OMIs) for a COS targeting appropriate polypharmacy in older patients in primary care.
METHODS: Following the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline, OMIs were identified from a Cochrane review focusing on appropriate polypharmacy. The quality of OMIs was assessed using a published checklist. Subsequently, two rounds of Delphi questionnaires were conducted via the SoGoSurvey® platform, engaging stakeholders (researchers, clinicians and journal editors specialising in geriatric primary care) to achieve consensus on OMIs using a scale encompassing \"agree\", \"disagree\", or \"unsure\". Consensus was achieved if 70% or more participants chose \"agree\" and 15% or fewer chose \"disagree.\"
RESULTS: The quality of 20 OMIs identified from the Cochrane review was evaluated. Seven OMIs were selected based on meeting the COSMIN guideline\'s minimum requirements. Out of 188 potential participants, 57 (30.3%) consented to participate. Rounds 1 and 2 of Delphi exercises were completed by 50 respondents, achieving agreement on three OMIs: \'number of serious adverse drug reactions (ADRs)\' (98%), \'number of deaths\' (76%), and \'number of patients who fell\' (70%) for measuring \'serious ADRs,\' \'mortality,\' and \'falls,\' respectively. No agreement was reached for \'medication appropriateness,\' \'medication side-effects,\' \'quality of life,\' and \'medication regimen complexity.\'
CONCLUSIONS: OMIs were selected for a limited number of outcomes in the polypharmacy COS. Future research should identify suitable OMIs for the remaining four outcomes.

OBJECTIVE: Ceiling effect may lead to misleading conclusions when using patient-reported outcome measure (PROM) scores as an outcome. The aim of this study was to investigate the potential source of ceiling effect-related errors in randomized controlled trials (RCTs) reporting no differences in PROM scores between study groups.
METHODS: A systematic review of RCTs published in the top 10 orthopedic journals according to their impact factors was conducted, focusing on studies that reported no significant differences in outcomes between two study groups. All studies published during 2012-2022 that reported no differences in PROM outcomes and used parametric statistical approach were included. The aim was to investigate the potential source of ceiling effect-related errors-that is, when the ceiling effect suppresses the possible difference between the groups. The proportions of patients exceeding the PROM scales were simulated using the observed dispersion parameters based on the assumed normal distribution, and the differences in the proportions between the study groups were subsequently analyzed.
RESULTS: After an initial screening of 2343 studies, 190 studies were included. The central 95% theoretical distribution of the scores exceeded the PROM scales in 140 (74%) of these studies. In 33 (17%) studies, the simulated patient proportions exceeding the scales indicated potential differences between the compared groups.
CONCLUSIONS: It is common to have a mismatch between the chosen PROM instrument and the population being studied increasing the risk of an unjustified \"no difference\" conclusion due to a ceiling effect. Thus, a considerable ceiling effect should be considered a potential source of error.

OBJECTIVE: To evaluate and synthesize psychometric properties of the MOS-SSS and to identify quality versions of MOS-SSS for use in future research and practice.
METHODS: A psychometric systematic review.
METHODS: Articles about the translation, adaptation, or validation of the MOS-SSS in Medline, PubMed, CINAHL, and Web of Science and their reference lists published before 11 November 2022.
METHODS: The review followed the Consensus Standards for the Selection of Health Measurement Instruments guidelines.
RESULTS: The review included 35 articles. Eleven versions of MOS-SSS (3, 4, 5, 6, 8, 12, 13, 16, 18, 19, and 22 items) have been validated in various populations and 13 languages. Of 14 studies developing a translated version of MOS-SSS, four studies performed both an experts\' evaluation of content validity and a face validity test; two studies reported translation evaluation in the form of a content validity index. Of 35 studies, six performed both exploratory factor analysis and confirmatory factor analysis for structural validity; hypotheses and measurements for construct validity testings were often not clearly stated; two examined criterion validity; and four assessed cross-cultural validity. Internal consistency reliabilities were commonly examined by calculating Cronbach\'s alpha and reported satisfactory. Five studies analysed test-retest reliabilities using intra correlation coefficient. Methodological concerns exist.
CONCLUSIONS: The English 19-item, Farsi Persian 19-item, and Vietnamese 19-item versions are recommended for future use in research and practice. Italian 19-item and Malaysian 13-item versions are not recommended to be used in future research and practice. All other versions considered in this review have potential use in future research and practice. Proper procedures for developing a translated version of MOS-SSS and validating the scale are recommended.
CONCLUSIONS: The review identified quality versions of MOS-SSS to measure social support in future research and practice. The study also indicated methodological issues in current validation studies. Application of the study findings and recommendations can be useful to improve outcome measurement quality and maximize the efficiency of resource use in future research and practice.
UNASSIGNED: This systematic review synthesized the evidence from previous research and did not involve any human participation.

The Inventory of Complicated Grief (ICG) is a commonly used self-report measure in psycho-oncology, best supportive care, and palliative medicine. However, existing validation studies yielded conflicting results regarding the structural validity. This study provides a psychometric review and conceptual replication of the ICG latent structure to test the hypothesis that existing studies overfit unreliable sources of variance, which overshadow the unidimensionality of the ICG. All proposed latent models identified in the psychometric review were tested in a series of confirmatory and exploratory structural equation models. Specifically, at least five to six latent intercorrelated factors were necessary to reach acceptable model fit. However, a general CG factor accounted for most variance and ICG sum scores showed predictable associations with anxiety and depressive symptoms, which suggests that the ICG is essentially unidimensional. There are indications that other measures of pathological grief show similar inconsistencies. Overall, potentially emerging subfacets of the ICG should not be interpreted as distinct \"symptom clusters.\" If time constraints are an issue as is often the case in clinical research, complicated grief may just be measured by a reduced item set without a significant loss of information or complexity.

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.

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.

OBJECTIVE: The skull base inventory (SBI) was developed to better assess health-related quality of life (HR-QOL) in patients with anterior and central skull base neoplasms treated by endoscopic and open approaches. The primary objective of this study was to prospectively assess the psychometric properties of the SBI.
METHODS: This study is part of a multi-center study of patients undergoing endoscopic and open procedures completed between 2012 and 2018. Participants were eligible if they were over 18 years of age; had benign or malignant anterior, antero-lateral, or central skull base tumors; and required either an open or endoscopic skull base surgical approach. In order to assess the psychometric properties of the SBI, patients completed the instrument at six time points (preoperative, 2 weeks, 3 months, 6 months, 12 months postoperative). Patients also completed the Anterior Skull Base (ASB) questionnaire and the Sinonasal Outcome Test (SNOT-22) to allow comparison to the SBI.
RESULTS: One hundred and eighty-seven patients were included across five centers, with 121 having an endoscopic procedure. Internal consistency (Cronbach\'s alpha = 0.95) and test-retest at 12 months and 12 months plus 2 weeks (intraclass correlation > 0.90) were excellent. Concurrent validity was demonstrated by very strong correlation between total SBI scores and ASB scores (r = 0.810 to 0.869, p < 0.001) and moderate correlation between nasal domain SBI scores and SNOT-22 scores (r = - 0.616 to - 0.738, p < 0.001). Convergent validity was demonstrated by moderate correlation between change in SBI scores and global QOL change (rs = 0.4942, p < 0.001). The minimally important clinical difference (global HR-QOL change of \"a little better\" or \"a little worse\") was 6.0.
CONCLUSIONS: The SBI questionnaire is reliable and valid for patients treated by both endoscopic and open approaches and can be used for assessment of HR-QOL in these settings.

Content validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM\'s content validity and grading the quality of the evidence in systematic reviews of PROMs.
An online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales (\'strongly disagree\' to \'strongly agree\'), and provided arguments for their ratings.
Discussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM.
The consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice.