COnsensus-based Standards For The Selection Of Health Measurement INstruments Research Articles

Psychometric Testing of the Cross-Culturally Adapted Thai Version of the Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale in Caregivers of Patients With Chronic Illnesses.

To evaluate the psychometric properties of the Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale (CSE-CSC). The CSE-CSC scale was developed congruently with the Caregiver Contribution to Self-Care of Patient with Chronic Illness Inventory (CC-SC-CII) to assess caregiver self-efficacy (CSE), the motivation factor of caregiving. Its applicability in Asian populations, including Thailand, was limited. Psychometric tests were guided by COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) principles. This included translating the English version into Thai, following the principles of good practice for the translation and cultural adaptation process for patient-reported outcome (PRO) measures. Nine nursing experts evaluated the content validity. The analysis included caregivers of patients with chronic conditions from 16 primary care centres in Thailand. We tested the structural validity using exploratory factor analysis (EFA), confirmatory factor analysis (CFA) and concurrent validity for CC-SC-CII-v2. We tested the scale's reliability with methods for multidimensional and unidimensional constructs, the intraclass correlation coefficients (ICCs) and measurement error variance. Kappa coefficient (k = 1.00) indicated the scale's excellent content validity. The final analysis included a total of 407 samples. The EFA with the first split-half subsample (n = 194) extracted a two-dimensional structure. One reflected CSE in Maintenance and Monitoring behaviour and another captured CSE in Management behaviour. CFA with the second split-half subsample (n = 213) and the overall sample (n = 407) supported the scale's bidimensional model with high factor loadings. Each dimension and the overall CSE-CSC scale positively correlated with each scale and the overall CC-SC-CII-v2. McDonald's ω and Cronbach's α (both ranged from 0.91-0.94) indicated excellent internal reliability. Test-retest reliability showed ICCs between 0.95 and 0.96. Measurement error yielded satisfactory results. Testing of the Thai CSE-CSC scale supported validity and reliability, indicating that the scale can apply to Thai caregivers. This scale can be used in clinical practice and research to evaluate CSE in contribution to patient self-care.

Uncovering the Daily Experiences of People Living With Advanced Cancer Using an Experience Sampling Method Questionnaire: Development, Content Validation, and Optimization Study.

The experience sampling method (ESM), a self-report method that typically uses multiple assessments per day, can provide detailed knowledge of the daily experiences of people with cancer, potentially informing oncological care. The use of the ESM among people with advanced cancer is limited, and no validated ESM questionnaires have been developed specifically for oncology. This study aims to develop, content validate, and optimize the digital Experience Sampling Method for People Living With Advanced Cancer (ESM-AC) questionnaire, covering multidimensional domains and contextual factors. A 3-round mixed methods study was designed in accordance with the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) and the European Organization for Research and Treatment of Cancer guidelines. The study included semistructured interviews with 43 people with stage IV breast cancer or stage III to IV lung cancer and 8 health care professionals. Round 1 assessed the appropriateness, relative importance, relevance, and comprehensiveness of an initial set of ESM items that were developed based on the existing questionnaires. Round 2 tested the comprehensibility of ESM items. Round 3 tested the usability of the digital ESM-AC questionnaire using the m-Path app. Analyses included descriptive statistics and qualitative content analysis. Following the first round, we developed an initial core set of 68 items (to be used with all patients) and a supplementary set (optional; patients select items), both covering physical, psychological, social, spiritual-existential, and global well-being domains and concurrent contexts in which experiences occur. We categorized items to be assessed multiple times per day as momentary items (eg, "At this moment, I feel tired"), once a day in the morning as morning items (eg, "Last night, I slept well"), or once a day in the evening as evening items (eg, "Today, I felt hopeful"). We used participants' evaluations to optimize the questionnaire items, the digital app, and its onboarding manual. This resulted in the ESM-AC questionnaire, which comprised a digital core questionnaire containing 31 momentary items, 2 morning items, and 7 evening items and a supplementary set containing 39 items. Participants largely rated the digital questionnaire as "easy to use," with an average score of 4.5 (SD 0.5) on a scale from 1 ("completely disagree") to 5 ("completely agree"). We developed the ESM-AC questionnaire, a content-validated digital questionnaire for people with advanced breast or lung cancer. It showed good usability when administered on smartphone devices. Future research should evaluate the potential of this ESM tool to uncover daily experiences of people with advanced breast or lung cancer, explore its clinical utility, and extend its validation to other populations with advanced diseases.

Consensus definition of a radiologically healed fistula on magnetic resonance imaging in perianal Crohn’s disease: an international Delphi study

IntroductionPerianal fistulising Crohn’s disease (pfCD) is a distinct and debilitating phenotype seen in around one-third of patients with CD. Clinical trials in pfCD are increasingly using magnetic resonance imaging (MRI) criteria as a primary endpoint, but there is heterogeneity in the radiological definition of a healed perianal fistula that currently limits our ability to perform meaningful meta-analyses of studies. Our aim is to standardise outcomes through the generation of an international consensus definition of a radiologically healed fistula.Methods and analysisThis international Delphi consensus study employs a two-part strategy.The first is a systematic review to identify a longlist of variables used to define radiological healing in pfCD. MRI-based indices used to score fistula severity and healing will be assessed for their methodological quality using Consensus-based Standards for the selection of health Measurement Instruments (COSMIN). The systematic review protocol will be conducted using COSMIN methodology and reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses.The second part will be an online Delphi consensus, guided by the results of the systematic review. Radiologists, gastroenterologists and colorectal surgeons with expertise in the management of pfCD will be invited to take part in two to three rounds of online surveys. Once an a priori threshold of >80% agreement is reached on individual radiological components used to define ‘healing’ and ‘healed’, a final meeting of key stakeholders will be organised to generate a consensus definition of a healed fistula.Ethics and disseminationThe study has been deemed exempt from a formal Research Ethics Committee review as no patients will participate directly in the consensus process, given the technical nature of the research question. The study is registered with the local R&D department (Reference RD24/007). Publication of this study will help standardise radiological endpoint measurement in clinical trials of pfCD and improve the synthesis and meta-analysis of comparative studies.PROSPERO registration numberCRD42024504334.

Integrated measure for training transfer in nursing practice: Development and validation study

BackgroundThe persistent knowledge-practice gap in nursing, where competencies gained through continuing professional development fail to integrate into practice, remains a significant challenge. Effective transfer of acquired knowledge and skills to the workplace is essential for bridging this gap. However, there is a lack of comprehensive, validated instruments to assess factors influencing training transfer in nursing practice. ObjectiveThis study aims to develop a questionnaire capable of assessing training transfer as an integrated construct, encompassing all factors influencing this process in nursing practice. DesignThe study followed a developmental, iterative approach guided by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). Setting(s)Eight tertiary teaching hospitals in the Netherlands. ParticipantsEducational experts (n = 8) and nurses (n = 1588). MethodsThe questionnaire development consisted of three phases: Phase 1) content development, in which instruments were identified based on a literature study and translation of included instruments into Dutch, Phase 2) pilot phase: content validation and usability testing using Delphi studies with experts and nurses, Phase 3) psychometric validation: construct validation using exploratory and confirmatory factor analysis, composite reliability and discriminant validity. The phases were completed from January 2023 till June 2024. ResultsThe literature review led to the inclusion of two key instruments: the Learning Transfer System Inventory (LTSI) and the Learning Climate Questionnaire (LCQ). Following item reduction based on Delphi rounds, nurses completed the adapted instruments. Psychometric validation demonstrated a good fit for these instruments in nursing practice. The adapted LTSI showed loadings ranging from 0.37 to 0.99, with a Normed Χ2 of 1.996, TLI of 0.908, CFI of 0.920, and RMSEA of 0.050 [CI = 0.047–0.054]. The adapted LCQ exhibited loadings from 0.64 to 0.94, with a Normed Χ2 of 3.385, TLI of 0.963, CFI of 0.974, and RMSEA of 0.069 [CI = 0.061–0.078]. The combined model demonstrated a Normed Χ2 of 2.014, TLI of 0.900, CFI of 0.907, and RMSEA of 0.051 [CI = 0.048–0.054]. ConclusionsThe adapted LTSI and LCQ, both separately and combined, are reliable and valid instruments for use in the Dutch nursing hospital context. Together, they provide a comprehensive assessment of factors influencing training transfer. They can also be used independently to examine specific components such as trainers (LCQ), context (LTSI), personal aspects (LTSI), or training (LTSI/LCQ). Furthermore, these instruments can facilitate discussions between nurses, managers, and educational experts to address barriers to training transfer in nursing practice.

Psychometric properties of self-reported measures of psychological birth trauma in puerperae: A COSMIN systematic review.

To identify and evaluate the psychometric properties of available patient-reported outcome measures (PROMs) of psychological birth trauma (PBT) in postpartum women. A literature search was carried out across eight databases-PubMed, Embase, Web of Science, CINAHL, PsycINFO, China National Knowledge Infrastructure (CNKI), Wanfang Database, and VIP Database for Chinese Technical Periodicals-covering studies published from the inception of each database up to 21 May 2024. English and Chinese language studies employing any research design and reporting at least one psychometric property of PBT in puerperae were included. Independent reviewers extracted data and followed the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines to evaluate three aspects of the included instruments: methodological quality, psychometric properties, and level of evidence assessed using the modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. Thirty-one studies with twelve PROMs were included, measurement error, cross-cultural validity, and responsiveness were not reported for most PROMs. Nine PROMs received a Class B recommendation, based on their measurement attribute ratings and overall evidence quality. In contrast, the CTI, IES-R, and PBTAS with high-quality evidence for insufficient measurement properties, so received a Class C recommendation. This systematic review provisionally recommends the City BiTS as credible tool for assessing PBT in both clinical practice and research involving puerperae. However, further comprehensive studies are needed to conduct more comprehensive validations of the psychometric properties of existing PROMs.

Patient-reported outcomes of chimeric antigen receptor T-cell therapy in hematologic malignancies: a systematic review and meta-analysis

Few studies evaluated patient-reported outcomes (PROs) for patients with hematologic malignancies receiving with Chimeric Antigen Receptor T (CAR-T) cell therapy. We performed a systematic review and meta-analysis to evaluate the benefits of CAR-T cell therapies focused on PROs. A systematic literature searched from PubMed, Cochrane, and the Web of Science from inception to September 2023. Study selection and data extraction were conducted independently by two reviewers based on pre-specified criteria. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist was used to evaluate the methodological quality of the included studies. The random-effects model was employed to calculate the combined effect and 95% Confidence intervals. This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline and the protocol was registered with PROSPERO (CRD42024586706). We identified 20,110 studies. Of those, 15 studies with 16 different PRO measures (PROMs) were included in the meta-analysis. CAR-T cell therapy improved PROs in the six domains of general health status, pain, fatigue, depression, social function, and cognitive function: from the general health status (SMD: 0.57, 95% CI: 0.34 to 0.81) to cognitive function (SMD: 0.25, 95% CI: 0.14 to 0.37). The current meta-analysis shows that CAR-T cell therapy produces clinically meaningful differences in PROs. These results suggest that the professional perspective and patient values and preferences should be weighed equally when considering CAR-T cell therapy for hematologic malignancies.

CARD-SARC: mixed-method study to develop a disease-specific health-related quality of life tool for cardiac sarcoidosis

Abstract Introduction Sarcoidosis is a rare inflammatory condition caused by the formation of lumps (granulomas) of abnormal tissue in any organ, and can affect physical, functional, mental, social and economic aspects of life. People living with cardiac sarcoidosis (CS) are likely to have worse clinical outcomes and greater impairment on health-related quality of life (HRQoL) than other sarcoidosis manifestations. HRQoL is the main concern for people living with sarcoidosis. However, measuring HRQoL in people with CS is difficult as existing tools focus on other forms of sarcoidosis (for example, lung, eye or skin involvement) or for specific cardiac symptoms (for example, atrial fibrillation, angina or heart failure), but not specifically for CS. Purpose To develop a disease-specific patient-reported outcome measure (CARD-SARC) to assess the impact of CS on HRQoL. Methods A sequential exploratory mixed-method, multicentre observational cohort study using a clinimetric approach was conducted. The McMaster Framework for evaluative instruments involved three steps (item selection, item scaling and item reduction) which were complemented with recommendations from the consensus-based standards for the selection of health measurement instruments (COSMIN). The item-generation process connected data from quantitative (theory, research findings and systematic review) and qualitative components (qualitative semistructured interviews, clinical observations and experts’ opinion). A simultaneous triangulation (QUAN+qual) method was followed to ensure a comprehensive list of preliminary items. The formatting of items was guided by patient and public involvement (PPI) with a 2-weeks recall period. The item reduction strategy was led by PPI and an international multidisciplinary clinical CS-experts. Results 740 potential items were generated by converging all the different sources and techniques. After removal of duplicates and simultaneous triangulation, a preliminary list with 111 items was reviewed by the CS-expert panel with 26 members (including 11 pulmonologists, 7 cardiologists, 5 CS-patients and 3 specialist-nurses). After a consensus meeting, the CARD-SARC included 61 relevant items in six sections for pilot-testing: "functioning", "social, leisure and occupation", "emotional", psychological", "physical" and "healthcare/self-care". Conclusions This study combined a robust methodology with active PPI engagement to develop the first disease-specific HRQoL tool for CS. Each data source was planned independently, however the input from PPI members was critical during the simultaneous triangulation for item-generation. The contributions of CS-experts (members of the PPI group and clinical multidisciplinary experts) enhanced the content validity of the CARD-SARC. The CARD-SARC has the potential to influence clinical management and treatment options, future research and health-economic stakeholders’ decisions for CS.

Patient-Reported Outcome Measures for Pelvic Organ Prolapse: A Systematic Review Using the COnsensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) Checklist.

Patient-reported outcome measures (PROMs) are recommended to measure the impact of a health condition or intervention effectiveness as they aim to capture what is most meaningful to patients. Several PROMs are used to evaluate pelvic organ prolapse (POP)-related domains, yet the measurement properties of these instruments have not been fully explored with a rigorous analysis of the methodological quality and quality of evidence. To conduct a systematic review reporting on the measurement properties of PROMs used for the assessment of POP-related domains in accordance with the COSMIN guidelines. Five databases were searched from inception to December 2023. Studies were eligible if they involved (1) at least one group of female adults diagnosed with or presenting with symptoms of POP; (2) a self-reported outcome measure (PROMs, questionnaires) to evaluate POP-related domains; and (3) at least one measurement property. Methodological quality and measurement quality were assessed using the COSMIN risk of bias (ROB) checklist and the COSMIN criteria for good measurement properties. A total of 13 PROMs were included. The BIPOP had the lowest ROB for Content Validity. The POP-SS was the only PROM with sufficient evidence of adequate construct validity and responsiveness to be used in both surgical and conservative management settings. This original work identified a gap in evidence regarding the measurement qualities of identified PROMs used in the POP population.

Cross-Cultural Adaptation and Validation of the Thai Version of the Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain and Osteoarthritis (KOOS-PF).

The Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) is a condition-specific patient-reported outcome measure that is used to evaluate patients with patellofemoral pain. To translate the KOOS-PF into the Thai language, to make necessary adaptations to a Thai cultural context, and to assess the measurement properties of the Thai version of the KOOS-PF (TH-KOOS-PF) using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Cohort study (diagnosis); Level of evidence, 3. This study was conducted between December 2021 and May 2023. Language translation of the KOOS-PF was performed according to guidelines for the cross-cultural adaptation of self-report measures. Eligible participants aged 18 to 50 years were asked to complete various patient-reported outcome measures including the TH-KOOS-PF at 3 time points: baseline, 2 weeks after baseline for test-retest reliability analysis, and 2 months after baseline for responsiveness assessment. The KOOS-PF was successfully translated and culturally adapted to create the TH-KOOS-PF. A total of 86 participants (mean age, 37.0 ± 8.1 years; 59.3% female) with patellofemoral pain participated in the validation process. Construct validity of the TH-KOOS-PF was demonstrated by confirmation of all a priori hypotheses. The standardized Cronbach alpha coefficient was 0.88 (95% CI, 0.83-0.91), which indicated good internal consistency. Test-retest reliability was high, with an intraclass correlation coefficient of 0.87 (95% CI, 0.77-0.92). The TH-KOOS-PF demonstrated good responsiveness, as evidenced by all predefined hypotheses' being confirmed, and there were no floor or ceiling effects. Using an anchor-based approach, the minimal clinically important difference was 11.6 points. The results of this study revealed the TH-KOOS-PF to be a valid, reliable, and responsive tool for assessing Thai patients with patellofemoral pain. The TH-KOOS-PF will be useful in both clinical and research settings.

Psychometric properties of self-report instruments for assessing self-care in patients with oncological diseases: protocol for a COSMIN-based systematic review

Background: The topic of self-care in cancer has garnered increased attention from researchers and clinicians over the years. This has prompted the development and testing of several instruments to capture the multidimensional nature of the self-care construct in cancer patients. Several self-report instruments are available in the literature; however, which instrument exhibits the best reliability and validity remains unclear.Objective: The aim of this protocol is to identify all available instruments developed for measuring self-care behaviors in adult cancer patients and critically appraise their psychometric properties.Methods: This systematic review will follow the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. PubMed, CINAHL, Embase, Scopus, Web of Science, and PsycINFO databases will be searched for relevant articles on the topic. Studies testing the psychometric properties of self-report instruments assessing self-care behaviors in adult cancer patients, published in English, Italian, or Spanish, will be included. Two independent reviewers will assess the eligibility of the studies and extract the data. Risk of bias will be evaluated using the COSMIN Risk of Bias Checklist, and the quality of the results will be assessed based on specific COSMIN criteria.Conclusion: A thorough and critical evaluation of all available evidence for instruments measuring self-care in patients with cancer might have both strong clinical and research implications. The results of this review could drive healthcare providers in the selection of the most appropriate assessment tool for detecting and monitoring the self-care levels of this population. On the other hand, the results may underline the necessity of validating new instruments.

A systematic review and meta-analysis of the parental stress scale's psychometric properties.

Parental stress can affect the ability of parents to cope with the challenges of raising children. The result can be a negative cycle within the family dynamic, which in turn can interfere with children's development and emotional regulation. Among the many instruments available to assess parental stress, the Parental Stress Scale (PSS) deserves particular mention. To our knowledge, there are currently no systematic reviews evaluating the psychometric properties of the PSS. The aim of this systematic review was to assess the psychometric properties of the PSS using the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) methodology and to conduct a meta-analysis. A thorough literature search was conducted from different databases. A meta-analysis to test the generalisability of PSS internal consistency across its component factors was performed. A total of 20 validation studies of the PSS were identified. Based on the COSMIN methodology, this instrument receives an 'A' rating, meaning that it is considered to be a cross-sectional instrument with the necessary scientific evidence for the assessment of the construct of parental stress. The meta-analysis testing the generalisability of its internal consistency yielded satisfactory results across the different factors. Future research should focus on those psychometric properties of the PSS that have not been studied as extensively, such as reproducibility, responsiveness, measurement error, and measurement invariance.

The spinal cord injury (SCI) peer support evaluation tool: the development of a tool to assess outcomes of peer support programs within SCI community-based organizations.

Guided by the 4-step process outlined in the Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline, multiple methodologies were used: Delphi, literature reviews, ratings with consensus, think-aloud, and test-retest. The purpose of this study was to develop and test a spinal cord injury (SCI) peer support evaluation tool that meets the needs of community-based SCI organizations in Canada. Peer support programs for people with SCI delivered by community-based SCI organizations. This research was co-constructed with executives and staff from SCI community-based organizations, people with SCI, researchers, and students. Given the multiple steps of this study, sample size and characteristics varied based on each step. Participants included people with SCI who received peer support (mentees) or provided peer support (mentors/supporters) and staff of community-based organizations. In step 1, the 20 most important outcomes for SCI peer support were identified. In step 2 and 3, the 97 items were identified to assess the outcomes and by using rating and multiple consensus methodologies 20 items, one to assess each outcome, were selected. In step 4, content and face validity and test-retest reliability were achieved. The resulting SCI Peer Support Evaluation Tool consists of 20single-item questions to assess 20 outcomes of SCI peer support. Through a systematic process, the SCI Peer Support Evaluation Tool is now ready to be implemented to assess outcomes of SCI peer support programs delivered by community-based SCI organizations.

Development of theoretical framework and digital competence assessment checklist (DCAC) for nursing students

BackgroundThe rapid development of digital technology impacts all aspects, including nursing education. Nursing programs are tasked with equipping graduates with both clinical skills and digital competence. However, inconsistencies in the conceptual understanding of digital competence in nursing literature, underscore the need to refine the concept. DesignThis study involved two phases including a modified Delphi approach and psychometric testing. In Phase 1, the panel of experts in nursing was invited to evaluate the theoretical framework, domain, and item of assessment checklist. In Phase 2, the psychometric properties of the assessment checklist were tested using a quantitative survey. SettingThe study was conducted in Taiwan, Indonesia, and Vietnam. ParticipantParticipants included 12 nursing experts from Taiwan, Indonesia, and Vietnam during the development phase and 417 nursing students from these countries in the validation phase. MethodsPhase 1 utilized a modified Delphi approach establishing a theoretical framework and assessment checklist. Experts provided feedback on a Likert scale, aiming for consensus. Phase 2 involved a quantitative survey where graduate nursing students rated the DCAC. The analysis process following the recommendation of the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). ResultsThe theoretical framework defined digital competence across four domains. In the first Delphi round, all items were rated above the consensus threshold. After two rounds, the CVI ranged from .8 to 1.0, suggesting strong agreement among experts. The second phase revealed high discriminant validity among survey items, with Cronbach's alpha indicating high internal consistency. The refined 22-item DCAC showed improved fit indices, confirming the assessment checklist's structure. ConclusionThe developed 22-item DCAC is a valid and reliable tool for measuring digital competence among nursing students. Integration of digital competence into nursing education is essential for preparing students to excel in the healthcare environment.

Content validity of measures in early numeracy in children up to eight years: A COSMIN systematic review

Early numeracy skills are considered essential predictors for later mathematical and educational achievement. Therefore, there is a need for early numeracy measures with psychometrically sound properties. This systematic review aimed to determine the content validity of all current early numeracy measures in accordance with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) framework and methodological guidelines, and was conducted and reported by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement and checklist. Systematic literature searches were conducted in January 2024 in five electronic databases: CINAHL, Embase, Eric, PsycINFO, and PubMed. Eligible measures assessed numeracy, targeted children up to eight years of age, were published in English in 1995 or later, and had psychometric data on measure dimensionality. Eligible psychometric reports that were published in English described instrument development and/or content validity of included measures. The measures’ methodological quality was assessed using the COSMIN Risk of Bias checklist, after which all three aspects of content validity (i.e., relevance, comprehensiveness and comprehensibility) were evaluated. Six early numeracy measures and eleven psychometric reports were included. None of the measures could be recommended for use in clinical practice, education, or research due to a lack of high-quality evidence on content validity. However, no high-quality evidence was found to indicate insufficient content validity, therefore, all measures still have the potential to be used. Limited access to measures in the domain of early numeracy, despite having contacted both publishers and instrument developers, may have negatively impacted the completeness of the current overview of content validity of early numeracy measures. In line with the COSMIN guidelines, after the initial evaluation of content validity, future studies should evaluate the remaining psychometric properties of the included measures to identify the most robust measures in terms of validity, reliability, and responsiveness.

Sleep-related measurements to assess sleep disturbances among people living with dementia in nursing homes: a systematic review.

There is a high prevalence of sleep disturbances among people living with dementia (PLWD) in nursing homes. Reliable and valid measurements are needed to assess these disturbances. The aim of this systematic review was to identify, analyze and synthesize studies of sleep-related measurements to assess sleep disturbances in PLWD. The databases PubMed, CINAHL, and PsycINFO were systematically searched in 2019; the search was updated in March 2024. The inclusion criteria were as follows: participants with dementia or probable dementia in any care setting; and studies that reported at least one of the following aspects: (I) theoretical and conceptual frameworks, (II) user or patient involvement by type of users in measurement development, (III) feasibility and practicability of measurements, and (IV) results of psychometric analyses. The quality of the included studies was evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria and the quality appraisal tool for studies of diagnostic reliability (QAREL) tool. A total of 5169 studies were identified; ultimately, 15 studies describing three self-administered measurements, three proxy-administered measurements and two technological measurements were included. No sleep-related measurement showed acceptable psychometric properties in any of the COSMIN domains. No measurement without adaptation can be recommended for PLWD in nursing homes. If existing measurements are used in clinical practice, the self-perspective of PLWD should be taken into account. If this is no longer fully possible, proxy-rating perspectives in combination could be an option. Future research on sleep-related measurements should be strictly based on international consensus-based psychometric quality criteria.

Patient-reported outcome measures for acute rhinosinusitis in adults and children: a systematic review of the quality of existing instruments

BackgroundAcute rhinosinusitis (ARS) is a self-limiting inflammation of the nose and sinuses caused by viral or bacterial infections that requires primarily symptomatic treatment. Patient-reported outcome measures (PROMs) are suitable tools for the assessment of the effectiveness of remedies for ARS from the patient’s perspective in clinical trials and real-world studies. Data regarding the quality of existing PROMs for ARS are limited.PurposeTo conduct a systematic review of the quality of existing disease-specific PROMs for use in adults and children with ARS according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, and to derive recommendations for use of the identified instruments in future clinical studies.MethodsWe systematically searched PubMed, Web of Science and Embase for studies reporting on the development and/or validation of PROMs for ARS. We assessed the methodological quality of each included study, evaluated the quality of measurement properties per PROM and study, and graded the evidence. Based on the overall evidence, we derived recommendations for use of the instruments.ResultsWe identified four studies on three PROMs measuring symptoms of ARS and quality of life in adults (Sinonasal Outcome Test-16, SNOT-16; Measurement of Acute Rhinosinusitis, MARS; Rhinosinusitis Quality-of-Life Assessment, RhinoQoL). For ARS in children, we identified two studies on two PROMs measuring symptoms of ARS (Pediatric Rhinosinusitis Symptom Scale, PRSS; Sinus Symptom Questionnaire, S5). Our assessment of measurement properties indicates that all instruments require further validation before they can be unrestrictedly recommended for use in future research (COSMIN category B). In particular, there were no content validity studies for any of the identified instruments, but also data on other important measurement properties, e.g., structural validity, are lacking.ConclusionCurrently, no PROM for ARS in adults and children can be unrestrictedly recommended based on the evaluation of their quality. Further validation is required for all identified PROMs. Content validation involving patients and experts should be given priority.Systematic review registrationOSF (https://doi.org/10.17605/OSF.IO/VAP8U).

A new patient-reported outcome measure for the evaluation of ankle instability: description of the development process and validation protocol

BackgroundAcute ankle sprains represent one of the most common traumatic injuries to the musculoskeletal system. Many individuals with these injuries experience unresolved symptoms such as instability and recurrent sprains, leading to chronic ankle instability (CAI), which affects their ability to maintain an active lifestyle. While rehabilitation programs focusing on sensorimotor, neuromuscular, strength and balance training are primary treatments, some patients require surgery when rehabilitation fails. A critical analysis of the patient-reported outcome tools (PROs) used to assess CAI surgical outcomes raises some concerns about their measurement properties in CAI patients, which may ultimately affect the quality of evidence supporting current surgical practice. The aim of this research is to develop and validate a new PRO for the assessment of ankle instability and CAI treatment outcomes, following recent methodological guidelines, with the implicit aim of contributing to the generation of scientifically meaningful evidence for clinical practice in patients with ankle instability.MethodsFollowing the COnsensus-based Standards for the selection of Health Measurement Instruments (COSMIN), an Ankle Instability Treatment Index (AITI) will be developed and validated. The process begins with qualitative research based on face‒to‒face interviews with CAI individuals to explore the subjective experience of living with ankle instability. The data from the interviews will be coded following an inductive approach and used to develop the AITI content. The preliminary version of the scale will be refined through an additional round of face‒to‒face interviews with a new set of CAI subjects to define the AITI content coverage, relevance and clarity. Once content validity has been examined, the AITI will be subjected to quantitative analysis of different measurement properties: construct validity, reliability and responsiveness.DiscussionThe development of AITI aims to address the limitations of existing instruments for evaluating surgical outcomes in patients with CAI. By incorporating patient input and adhering to contemporary standards for validity and reliability, this tool seeks to provide a reliable and meaningful assessment of treatment effects.Trial registrationNot applicable.

Screening instruments for mental disorders in primary healthcare: a scoping review protocol (SCREENING-MD)

IntroductionWhen mental disorders go undetected until later stages, they can result in poorer health outcomes for patients. Primary healthcare (PHC) stands as a strategic setting for the early identification and...

Systematic review and meta-analysis of developmental assets scales: A study protocol for psychometric properties.

Application of developmental assets, one of existing Positive Youth Development (PYD) frameworks, has gained momentum in research, policy formulations, and interventions, necessitating the introduction of the most efficient scales for this framework. The present study protocol aims to conduct a systematic review and meta-analysis of developmental assets scales to document the underlying logic, objectives, and methodologies earmarked for the identification, selection, and critical evaluation of these scales. In accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P), the intended search will encompass databases of PubMed, Scopus, Web of Knowledge, and PsycINFO, spanning from the inception of 1988 to 1st of April 2024. The review will include articles published published in English language focusing on individuals aged 10 to 29 years and reporting at least one type of reliability or validity of developmental assets scales. The review process will be in compliance with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), and the overall quality of evidence will be determined using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) guidelines. This comprehensive assessment aims to identify potential biases in prior research and offer guidance to scholars regarding the optimal scales for developmental assets in terms of validity, reliability, responsiveness, and interpretability The evidence-based appraisal of the scales strengths and limitations is imperative in shaping future research, enhancing their methodological rigor, and proposing refinements to existing instruments for developmental assets.

Cross-cultural adaptation of the Avoidance of Daily Activities Photo Scale for Turkish patients with shoulder pain: Reliability and validity assessment according to the COSMIN guideline

ContextPeople with chronic or long-term pain may develop various psychosocial symptoms such as fear and avoidance of behavior due to pain. Reliable and valid quality of life tools must be available in Turkish to specifically assess avoidance of behavior in people with shoulder pain. ObjectivesThis study aimed to translate and culturally adapt the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain and to evaluate the psychometric properties of its Turkish version (ADAP-Tr) in patients with shoulder pain. MethodsTranslation, adaptation, and validation were performed according to the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) guidelines. The internal consistency, reliability, construct validity, and discriminant validity of the ADAP-Tr were tested. The Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia (TSK), and Shoulder Pain and Disability Index (SPADI) were applied for validation purposes. ResultsThe study included a total of 162 participants with shoulder pain. The internal consistency of the ADAP-Tr showed excellent reliability with a Cronbach's α of 0.94 and a test-retest assessment of 0.88 ICC (95% CI, 0.83-0.91). The standard error of measurement was 1.85 points, and the minimal detectable change was determined 5.12 points. There was a low to high correlation among the ADAP-Tr and PCS (r = 0.481, p < .001), TSK (r = 0.448, p < .001), and SPADI (r = 0.826, p < .001) scores. ConclusionsThe ADAP-Tr was shown to be a valid and strong reliability tool to use in clinical and research settings as a shoulder-specific measurement tool.