Development and content validity of an application to assess 24-hour movement behaviors in 0-4-year-old children involving end-users and key stakeholders: the My Little Moves app.

BACKGROUND: Recently, research focus has shifted to the combination of all 24-h movement behaviors (physical activity, sedentary behavior and sleep) instead of each behavior separately. Yet, no reliable and valid proxy-report tools exist to assess all these behaviors in 0-4-year-old children. By involving end-users (parents) and key stakeholders (researchers, professionals working with young children), this mixed-methods study aimed to 1) develop a mobile application (app)-based proxy-report tool to assess 24-h movement behaviors in 0-4-year-olds, and 2) examine its content validity. METHODS: First, we used concept mapping to identify activities 0-4-year-olds engage in. Parents (n = 58) and professionals working with young children (n = 21) generated a list of activities, sorted related activities, and rated the frequency children perform these activities. Second, using multidimensional scaling and cluster analysis, we created activity categories based on the sorted activities of the participants. Third, we developed the My Little Moves app in collaboration with a software developer. Finally, we examined the content validity of the app with parents (n = 14) and researchers (n = 6) using focus groups and individual interviews. RESULTS: The app has a time-use format in which parents proxy-report the activities of their child, using eight activity categories: personal care, eating/drinking, active transport, passive transport, playing, screen use, sitting/lying calmly, and sleeping. Categories are clarified by providing examples of children's activities. Additionally, 1-4 follow-up questions collect information on intensity (e.g., active or calm), posture, and/or context (e.g., location) of the activity. Parents and researchers considered filling in the app as feasible, taking 10-30 min per day. The activity categories were considered comprehensive, but alternative examples for several activity categories were suggested to increase the comprehensibility and relevance. Some follow-up questions were considered less relevant. These suggestions were adopted in the second version of the My Little Moves app. CONCLUSIONS: Involving end-users and key stakeholders in the development of the My Little Moves app resulted in a tailored tool to assess 24-h movement behaviors in 0-4-year-olds with adequate content validity. Future studies are needed to evaluate other measurement properties of the app.

Assessing the Content Validity of Preference-Based Measures in Cancer.

OBJECTIVES: This study assessed the content validity of generic and condition-specific preference-based measures (PBMs) with patients treated for cancer, evaluated against 10 Consensus-Based Standards for the Selection of Health Measurement Instruments criteria for good content validity, to best inform measurement strategies regarding the use of PBMs in oncology development programs and real-world applications. METHODS: Individual, semistructured interviews were conducted with patients who received drug treatment for cancer in the United Kingdom (n = 47) and the United States (n = 49). During the interview, patients completed 3 generic PBMs (EQ-5D-5L, EuroQol Health and Wellbeing measure-Short Form, Château Santé Base) and 2 condition-specific PBMs (Quality of Life Utility-Core 10 Dimension, Functional Assessment of Cancer Therapy Eight Dimension [FACT-8D]). Interviews were conducted via teleconference, audio recorded, and transcribed verbatim. Transcripts were coded using thematic and content analysis methods. RESULTS: Condition-specific measures were evaluated as having better relevancy than generic PBMs. Overall, the FACT-8D was evaluated as holding the best content validity in terms of relevancy, and the EuroQol Health and Wellbeing measure-Short Form received the most favorable evaluation of relevancy for generic PBMs. All measures demonstrated comparable comprehensiveness, with all suggested by patients to be missing concepts. The EQ-5D-5L was evaluated best in terms of comprehensibility. This was followed by the Quality of Life Utility-Core 10 Dimension and FACT-8D; both received similar evaluations. CONCLUSIONS: All measures were generally seen by patients as adequate in capturing appropriate aspects of health-related quality of life for measuring cancer outcomes, although together condition-specific measures were evaluated as having better relevancy than generic PBMs. Further health-related quality of life instrument development is encouraged, particularly with regard to the longer-term detrimental impacts of cancer and treatment side effects. Other developments could include new cancer-specific tools inclusive of conventional health items, treatment impacts, and psychological items.

A Systematic Review and Quality Assessment of Cardiovascular Disease-Specific Health-Related Quality-of-Life Instruments Part I: Instrument Development and Content Validity.

OBJECTIVES: Health-related quality-of-life (HRQoL) instruments for cardiovascular diseases (CVD) have been commonly used to measure important patient-reported outcomes (PROs) in clinical trials and practices. This study aimed at systematically identifying and assessing the content validity of CVD-specific HRQoL instruments in clinical studies. METHODS: The research team searched Cumulative Index to Nursing and Allied Health Literature, Embase, and PubMed from inception to January 20, 2022. The research team included studies that reported the development and content validity for CVD-specific instruments. Two reviewers independently assessed the methodological quality using the Consensus-based Standards for the Selection of Health Measurement Instruments methods on evaluating content validity of PROs. Content analysis was used to categorize the items included in the instruments. RESULTS: The research team found 69 studies reporting the content validity of 40 instruments specifically developed for CVD. Fourteen (35.0%) were rated "sufficient" with very low to moderate quality of evidence. For PRO development, all instruments were rated "doubtful" or "inadequate." Twenty-eight (70.0%) instruments cover the core concepts of HRQoL. CONCLUSIONS: The quality of development and content validity vary among existing CVD-specific instruments. The evidence on the content validity should be considered when choosing a HRQoL instrument in CVD clinical studies and health economic evaluations.

How Well Does the EQ-5D-Y-5L Describe Children With Intellectual Disability?: "There's a Lot More to My Child Than That She Can't Wash or Dress Herself."

OBJECTIVES: The EQ-5D-5L is a generic health utility instrument for measuring health-related quality of life (HRQoL), with self-report and proxy report versions for children (EQ-5D-Y-5L). Children with intellectual disability (ID) are a heterogeneous population whose impairments and comorbidities place them at risk of poor HRQoL. This study aimed to describe the content validity and suitability for children with ID of a proxy report version of the EQ-5D-Y-5L as seen by their caregivers. METHODS: A proxy report EQ-5D-Y-5L was administered to caregivers of children with ID. Using cognitive think-aloud interviewing, participants were encouraged to provide the reasoning for their choices, assess the questions' relevance, comprehensibility, and comprehensiveness, and comment on the tool's strengths and weaknesses. Qualitative content analysis used both directed (deductive) and conventional (inductive) methods. RESULTS: There were 28 interviews with 30 caregivers of children with ID (aged 8-22 years, 17 boys, with autism spectrum disorder, cerebral palsy, Down syndrome, and rare genetic disorders). The EQ-5D-Y-5L was considered clear, concise, and largely relevant, but insufficiently comprehensive for this population. Interviewees sought clarification of the definition of HRQoL, whether it included unchanging impairments (vs fluctuating health states), and what basis of comparison to use (child or peer). Many interviewees suggested inclusion of questions for other domains, including communication and social engagement, equipment and human supports required, and a wider range of mental health questions. CONCLUSIONS: The study suggests that further work is required to ensure accurate responses to the EQ-5D-Y-5L from caregivers of children with ID and to describe these children adequately.

Cross-cultural adaptation and content validation of the Singapore English version of EQ-5D-Y: a qualitative study.

BACKGROUND: The EQ-5D-Y is a generic preference-weighted measure for children and adolescents which was developed within Europe. Two versions exist, the EQ-5D-Y-3L (Y-3L) and EQ-5D-Y-5L (Y-5L). This study aimed to cross-culturally adapt the Y-3L and Y-5L for use in Singapore and to assess the content validity, specifically, the relevance and comprehensiveness of the EQ-5D-Y descriptive system (DS) in Asia. METHODS: To culturally adapt the instruments, an expert panel consisting of paediatricians and primary school educators were consulted. Modifications suggested by the expert panel were tested via cognitive debriefing interviews with children aged 8-12 in Singapore. To assess the content validity of the EQ-5D-Y DS, interviews were conducted with both healthy (n = 8) and ill children (n = 6) aged 8-15. In the interviews, children discussed their experience with poor health and commented on the comprehensiveness and relevance of the EQ-5D-Y DS. RESULTS: The cross-cultural adaptation process led to minor modifications to the UK English Y-3L and Y-5L versions, including using phrases familiar to the local children and adding examples to facilitate understanding. The five health dimensions in the EQ-5D-Y DS were spontaneously elicited when children discussed their experience with poor health. All health dimensions related to poor health elicited from the interviews fell into three broad categories: physical health (e.g. Appetite, Mobility, and Sleep), mental well-being (e.g. Annoyed/Frustrated and Scared/Worried), and social relationships (e.g. Family and Friends). The EQ-5D-Y DS was generally found to be relevant and comprehensive, although some health dimensions that may be relevant to the local population (Social relationship and Appetite) were not covered. CONCLUSIONS: The UK English EQ-5D-Y instruments were adapted to produce the Singapore English EQ-5D-Y instrument that were comprehensible to local children as young as 8 years old. The EQ-5D-Y DS was generally relevant and comprehensive to measure poor health of local children. Future studies should ascertain the benefits of adding bolt-on items related to social relationships and appetite to the EQ-5D-Y DS.

Appropriateness of the EQ-5D-5L in capturing health-related quality of life in individuals with transfusion-dependent ß-thalassemia: a mixed methods study.

BACKGROUND: Individuals with transfusion-dependent ß-thalassemia (TDT) experience symptoms and functional impacts that reduce their health-related quality of life. However, EQ-5D-derived health utility index scores in TDT often indicate good HRQoL, suggesting the EQ-5D may not adequately capture the impact of TDT. This study explored the disease and treatment burden of TDT and examined the appropriateness of the EQ-5D-5L descriptive system (DS) in measuring HRQoL in TDT. METHODS: Adults with TDT in the United Kingdom, United States, and France completed a background questionnaire and EQ-5D-5L DS, followed by 60-minute semi-structured interviews on symptoms and HRQoL impacts of TDT (concept elicitation) and appropriateness of EQ-5D-5L DS (cognitive debrief). Transcribed interviews were analyzed using thematic and content analyses. The relationship between TDT symptoms and impacts were summarized in a conceptual model. EQ-5D-5L DS was mapped to concepts identified in the qualitative data to assess its capture of HRQoL concepts. Participants' EQ-5D-5L DS scores were compared to their qualitative descriptions for each dimension to assess their concordance. RESULTS: Thirty participants in the United States (n = 14 [46.7%]), United Kingdom. (n = 12 [40.0%]), and France (n = 4 [13.3%]) completed the study (73.3% female; mean age = 28.4 years [standard deviation (SD) = 5.1]; mean annual red blood cell transfusion [RBCT] frequency = 18.4 [SD = 7.6]). Participants reported TDT symptoms and impacts on HRQoL, all fluctuating across the RBCT cycle. EQ-5D-5L DS did not fully capture 11 of 16 (68.8%) HRQoL concepts reported. Most participants (n = 20/27 [74.1%]) reported that EQ-5D-5L DS did not capture important aspects of living with TDT, and 42.9% (n = 12/28) reported negative/neutral overall impressions of EQ-5D-5L DS. The highest degree of discordance between participants' qualitative data and EQ-5D-5L DS dimension scores was observed with mobility (42.3%) and self-care (34.6%), where the qualitative descriptions relating to these dimensions were worse than their quantitative scores. CONCLUSION: Current findings suggest that EQ-5D-5L DS lacks content validity and the derived health utility index score may not fully represent the burden of disease in TDT.

Content validity of the EQ-5D-5L with skin irritation and self-confidence bolt-ons in patients with atopic dermatitis: a qualitative think-aloud study.

OBJECTIVES: Two bolt-on dimensions (skin irritation, self-confidence) have been developed for the EQ-5D-5L to improve its content validity and responsiveness in psoriasis. However, the two bolt-ons are not strictly psoriasis-specific and are potentially relevant in other skin conditions. This study aims to explore the content validity of the EQ-5D-5L with two bolt-ons in patients with atopic dermatitis (AD). METHODS: In 2021-2022, qualitative, semi-structured interviews were conducted with 20 adult AD patients at a university dermatology clinic in Hungary. We aimed for a heterogeneous sample in terms of age, gender, education and disease severity. Patients completed the EQ-5D-5L with two bolt-ons using a think-aloud protocol. Probing questions were posed to investigate item relevance, potential conceptual overlaps, missing concepts and the appropriateness of the recall period. Interview transcripts were subjected to thematic analysis. RESULTS: The EQ-5D-5L with the two bolt-ons covered the most important aspects of health-related quality of life in AD patients. Most patients found both the skin irritation and self-confidence bolt-ons relevant. Fifteen potential missing concepts were identified, but only two (social relationships, judgement by others) were identified by more than one patient. A smaller conceptual overlap was found between the skin irritation and pain/discomfort dimensions in 7 patients (35%). Half the patients expressed a preference for a recall period of 1 week rather than of 'today'. CONCLUSIONS: The EQ-5D-5L with skin irritation and self-confidence bolt-ons showed good relevance, comprehensiveness and comprehensibility in patients with AD. However, in terms of comprehensiveness, social relationships and judgement by others (stigma) may be missing from the questionnaire.

Content and face validity of Workplace COVID-19 Knowledge & Stigma Scale (WoCKSS).

BACKGROUND: The COVID-19 pandemic has led to fear, rumours, and stigma, particularly against those infected with the virus. In Malaysia, the manufacturing industry is particularly vulnerable to COVID-19 clusters, making it critical to assess stigma attitudes among workers. To address this issue, The Workplace COVID-19 Knowledge & Stigma Scale (WoCKSS) was developed specifically for use in the manufacturing industry which served as the sample population for testing this scale. It was developed in the Malay language to ensure alignment with the local context. This study examines the content and face validity of WoCKSS, which can help assess the level of knowledge and stigma associated with COVID-19 among workers. METHODS: The WoCKSS was developed with 20 and 31 items for knowledge and stigma domains, respectively, based on an extensive review of COVID-19 literature. Content validation was conducted by four experts using a content validation form to assess the relevancy of each item to the intended construct. Content Validity Index (CVI) was calculated to measure the agreement between the experts on the relevance of each item to the intended construct. Face validation was then conducted by randomly selecting 10 respondents from the manufacturing industry, who rated the clarity and comprehension of each item using a face validation form. The Item Face Validity Index (I-FVI) was calculated to determine the clarity and comprehension of each question, and only items with an I-FVI ≥ 0.83 were retained. RESULTS: The WoCKSS achieved excellent content validity in both knowledge and stigma domains. Only 19 items from the knowledge domain and 24 items from the stigma domain were retained after CVI analysis. All retained items received a CVI score of 1.00, indicating perfect agreement among the experts. FVI analysis resulted in 17 items for the knowledge domain and 22 items for the stigma domain. The knowledge domain achieved a high level of agreement among respondents, with a mean I-FVI of 0.91 and a S-FVI/UA of 0.89. The stigma domain also showed high agreement, with a mean I-FVI of 0.99 and a S-FVI/UA of 0.86. CONCLUSION: In conclusion, the WoCKSS demonstrated high content and face validity. However, further testing on a larger sample size is required to establish its construct validity and reliability.

Follow-up after major traumatic injury: a survey of services in Australian and New Zealand public hospitals.

BACKGROUND: Increased survival from traumatic injury has led to a higher demand for follow-up care when patients are discharged from hospital. It is currently unclear how follow-up care following major trauma is provided to patients, and how, when, and to whom follow-up services are delivered. The aim of this study was to describe the current follow-up care provided to patients and their families who have experienced major traumatic injury in Australia and New Zealand (ANZ). METHODS: Informed by Donabedian's 'Evaluating the Quality of Medical Care' model and the Institute of Medicine's Six Domains of Healthcare Quality, a cross-sectional online survey was developed in conjunction with trauma experts. Their responses informed the final survey which was distributed to key personnel in 71 hospitals in Australia and New Zealand that (i) delivered trauma care to patients, (ii) provided data to the Australasian Trauma Registry, or (iii) were a Trauma Centre. RESULTS: Data were received from 38/71 (53.5%) hospitals. Most were Level 1 trauma centres (n = 23, 60.5%); 76% (n = 16) follow-up services were permanently funded. Follow-up services were led by a range of health professionals with over 60% (n = 19) identifying as trauma specialists. Patient inclusion criteria varied; only one service allowed self-referral (3.3%). Follow-up was within two weeks of acute care discharge in 53% (n = 16) of services. Care activities focused on physical health; psychosocial assessments were the least common. Most services provided care for adults and paediatric trauma (60.5%, n = 23); no service incorporated follow-up for family members. Evaluation of follow-up care was largely as part of a health service initiative; only three sites stated evaluation was specific to trauma follow-up. CONCLUSION: Follow-up care is provided by trauma specialists and predominantly focuses on the physical health of the patients affected by major traumatic injury. Variations exist in terms of patient selection, reason for follow-up and care activities delivered with gaps in the provision of psychosocial and family health services identified. Currently, evaluation of trauma follow-up care is limited, indicating a need for further development to ensure that the care delivered is safe, effective and beneficial to patients, families and healthcare organisations.

Content validity of SarQoL, a quality of life questionnaire specific to sarcopenia.

BACKGROUND: The Sarcopenia & Quality of Life (SarQoL) questionnaire is a patient-reported outcome measure designed for assessing health-related quality of life in individuals with sarcopenia. Despite its wide acceptance in the scientific literature, its content validity has only been partially demonstrated so far. AIMS: To enhance the evidence supporting the content validity of the SarQoL questionnaire. METHODS: Following COSMIN methodology, semi-structured interviews were conducted with 17 Belgian older adults who met the EWGSOP2 criteria for the diagnosis of sarcopenia and 11 experts in sarcopenia, with clinical or research background. Comprehensiveness, relevance and comprehensibility of SarQoL content were assessed through individual transcripts and were qualitatively analyzed thematically according to the seven dimensions of SarQoL. RESULTS: The majority of the concepts elicited during the semi-structured interviews fitted within existing SarQoL dimensions. Importantly, the different domains of SarQoL were consensually considered as relevant by patients and experts. Some new emergent concepts were identified by the participants. While many of them could be considered as enrichments of existing dimensions or sub-concepts, other new concepts (i.e. self-fulfilment, acceptance of the reduced condition, adaptation/use of strategies, depression) may highlight two potential dimensions not covered by SarQoL, i.e. patient empowerment and depression. Cognitive interviews also highlighted that SarQoL items and instructions were clear and comprehensible. CONCLUSIONS: SarQoL, in its current form, demonstrates good evidence of content validity for assessing health-related quality of life in patients with sarcopenia. We do not recommend adding new items or dimensions to SarQoL. Instead, for researchers or clinicians who aim to specifically address self-empowerment or depression of sarcopenic populations, we suggest completing the assessment of quality of life by concurrently using additional validated scales of patient empowerment or depression.

Formative peer evaluation instrument for a team-based learning course: Content and construct validity.

PURPOSE: Team-based learning (TBL) is an evidence-based approach to promote teamwork. Peer evaluation (PE) is an essential component to shape future team engagement and promote reflection. As PEs vary in use, implementation, and assessment, this study establishes the content and construct validity of a formative PE tool for a TBL course. METHODS: A ten-item instrument was developed based on a comprehensive review of PE literature and was critically edited by a team of experienced educators. Each student in a graduate histology course rated peers at two timepoints on a scale from Never to Always (0-3). The instrument's factor structure was analyzed by dividing the response set (D1 and D2); with D1 utilized for exploratory factor analysis (EFA) and D2 for confirmatory factor analysis (CFA). Cronbach's alpha assessed internal consistency. RESULTS: Data from 158 students across four cohorts were included in the analyses (D1, D2 = 972). A three-factor solution had good overall internal consistency (alpha = 0.82), and within the subscales ranged from 0.67 to 0.81. The factor structures were resonant with existing literature on (1) preparation, (2) providing feedback, and (3) feedback receptivity and attitude. CONCLUSION: This study establishes evidence of content and construct validity of a formative PE instrument for a TBL course.

Development of a self-report measure of empowerment along the hearing health journey: a content evaluation study.

OBJECTIVE: To conduct the first phases in the development of a self-report measure of empowerment on the hearing health journey, specifically, item generation and content evaluation of the initial pool of items generated. DESIGN: A content expert panel survey and cognitive interviews were conducted. Descriptive statistics were obtained for the quantitative data, and the cognitive interviews were analysed using thematic analysis. STUDY SAMPLE: Eleven researchers and clinicians participated in the content expert surveys. Sixteen experienced hearing aid users participated in the cognitive interviews, recruited from the USA and Australia. RESULTS: The items underwent five iterations based on feedback from the survey and interview data. This resulted in a set of 33 quality-tested potential survey items that were rated highly for relevance (mean = 3.96), clarity (mean = 3.70) and fit to dimensions of empowerment (mean = 3.92) (scale 0-4, where 4 was the maximum rating). CONCLUSIONS: Involving stakeholders in item generation and content evaluation increased relevance, clarity, fit to dimension, comprehensiveness, and acceptability of the items. This preliminary version of the 33-item measure underwent further psychometric refinement (Rasch analysis and traditional classical test theory testing) to validate it for clinical and research use (reported separately).

Health-related quality of life for children with anterior cruciate ligament deficiency: Ensuring content validity of the new KIDS-KNEES-ACL questionnaire.

PURPOSE: The existing knee-specific pediatric patient-reported outcome measures (PROMs) lack content and construct validity for children with anterior cruciate ligament (ACL) injury. This impairs their accuracy which can lead to false interpretations of data and inaccurate clinical guidelines. The purpose of this study was to develop a content-valid PROM for children with an ACL injury. METHODS: The process adhered to the COnsensus-based Standards for the selection of health Measurement INstruments guidelines for PROM development. Informants were children with ACL deficiency and sampled based on age, sex, and treatment. Semistructured interviews were conducted exploring themes within the International Classification of Functioning, Disability and Health model. Interviews continued beyond data saturation. By thematic analysis and by probing items from the adult PROM 'KNEES-ACL', new themes and items emerged. Content coverage, relevance and understandability were continuously evaluated. All interviews were recorded and transcribed verbatim. The NVivo 12 software was used for data analysis and coding of items. RESULTS: A PROM of 60 items across nine subscales was formed. From cognitive interviews, 19 new items emerged. Forty-one of 55 items from KNEES-ACL were endorsed as relevant; however, all required rewording to ensure understandability. Substantial differences in the psychosocial impact between adults and children were observed. The children experienced a more considerable negative psychosocial impact caused by a loss of participation in sports, lower self-confidence and loss of social networks. This resulted in four new domains. The physical issues were similar to adults, with few exceptions. CONCLUSION: The 'KIDS-KNEES-ACL' 1.0 (qualitative version) was developed. This version will be subjected to psychometric analysis, resulting in adequate measurement properties of the final KIDS-KNEES-ACL 2.0. As the only adequate pediatric ACL-specific PROM, its use in clinical trials and databases will enhance PROM data quality, and strengthen clinical guidelines and thus the treatment of children with ACL injury. LEVEL OF EVIDENCE: Not applicable.

Assessment of patients with head and neck cancer using the MD Anderson Dysphagia Inventory: Results of a study into its comprehensiveness, comprehensibility and relevance to clinical practice.

BACKGROUND: The MD Anderson Dysphagia Inventory (MDADI) is a widely used patient-reported outcome measure (PROM) which assesses dysphagia-related quality of life (QoL) in head and neck cancer (HNC). Despite its common use in HNC research and clinical practice, few of its psychometric properties have been reappraised since its inception. The aim of this study was to perform a survey-based qualitative analysis of UK HNC clinicians' perceptions of the content validity of the MDADI, evaluating it across the parameters of relevance, comprehensiveness and comprehensibility as per the COSMIN guideline for PROM assessment. RESULTS: Four themes relating to the content validity of the MDADI were identified: (1) MDADI items lack clarity of definition of the terms 'swallowing', 'eating' and 'dysphagia'; (2) the MDADI is perceived to be overly negative in tone including items that service users may find distressing or disempowering; (3) items in the tool are exclusory to specific subgroups of patients, such as those who are nil by mouth or socially isolated; and (4) modifications to the MDADI were suggested and encouraged to make it more clinically useful and patient-centred. CONCLUSIONS: This study indicates that MDADI's content validity is 'insufficient' when rated by COSMIN parameters. This has significant implications for its continued use in HNC research and clinical practice. Further re-evaluation of the content validity of the MDADI is warranted, with potential future amendment of items being indicated if the results of this study are corroborated in subsequent research. WHAT THIS PAPER ADDS: What is already known on the subject The MD Anderson Dysphagia Inventory (MDADI) patient-reported outcome measure of dysphagia-related quality of life is widely used in clinical practice and international clinical trials. Content validity is considered to be the most important property of a tool when assessing its psychometric strengths and weaknesses; however, the MDADI's content validity has not been reappraised since its initial development. What this paper adds to existing knowledge This study presents UK speech and language therapists' opinions and experience of the content validity of the MDADI and this first reappraisal of its content validity since its initial development highlights several issues with this psychometric parameter of the tool. This study highlights that further re-evaluation of the content validity of the MDADI is warranted, with potential future amendment of items being indicated if the results of this study are corroborated in subsequent research. What are the potential or actual clinical implications of this work? Clinicians cannot assume that commonly used outcomes tools have strong psychometric profiles. Consideration of the content validity of outcomes tools during selection for use in clinical and research practice should be key, as this will encourage use of tools that produce relevant, valid data that can contribute meaningfully to patient-centred care.

Adaptation and validation of the evidence-based practice profile (EBP2) questionnaire in a Norwegian primary healthcare setting.

BACKGROUND: Access to valid and reliable instruments is essential in the field of implementation science, where the measurement of factors associated with healthcare professionals' uptake of EBP is central. The Norwegian version of the Evidence-based practice profile questionnaire (EBP2-N) measures EBP constructs, such as EBP knowledge, confidence, attitudes, and behavior. Despite its potential utility, the EBP2-N requires further validation before being used in a cross-sectional survey targeting different healthcare professionals in Norwegian primary healthcare. This study assessed the content validity, construct validity, and internal consistency of the EBP2-N among Norwegian primary healthcare professionals. METHODS: To evaluate the content validity of the EBP2-N, we conducted qualitative individual interviews with eight healthcare professionals in primary healthcare from different disciplines. Qualitative data was analyzed using the "text summary" model, followed by panel group discussions, minor linguistic changes, and a pilot test of the revised version. To evaluate construct validity (structural validity) and internal consistency, we used data from a web-based cross-sectional survey among nurses, assistant nurses, physical therapists, occupational therapists, medical doctors, and other professionals (n = 313). Structural validity was tested using a confirmatory factor analysis (CFA) on the original five-factor structure, and Cronbach's alpha was calculated to assess internal consistency. RESULTS: The qualitative interviews with primary healthcare professionals indicated that the content of the EBP2-N was perceived to reflect the constructs intended to be measured by the instrument. However, interviews revealed concerns regarding the formulation of some items, leading to minor linguistic revisions. In addition, several participants expressed that some of the most specific research terms in the terminology domain felt less relevant to them in clinical practice. CFA results exposed partial alignment with the original five-factor model, with the following model fit indices: CFI = 0.749, RMSEA = 0.074, and SRMR = 0.075. Cronbach's alphas ranged between 0.82 and 0.95 for all domains except for the Sympathy domain (0.69), indicating good internal consistency in four out of five domains. CONCLUSION: The EBP2-N is a suitable instrument for measuring Norwegian primary healthcare professionals' EBP knowledge, attitudes, confidence, and behavior. Although EBP2-N seems to be an adequate instrument in its current form, we recommend that future research focuses on further assessing the factor structure, evaluating the relevance of the items, and the number of items needed. REGISTRATION: Retrospectively registered (prior to data analysis) in OSF Preregistration. Registration DOI: https://doi.org/10.17605/OSF.IO/428RP .

Development and content validity of the cognition in daily life scale (CDL).

Cognitive impairment can negatively influence daily functioning. Current cognitive measures are essential for diagnosing cognitive impairment, but findings on these tests do not always represent the level of cognitive functioning in daily life. Therefore, this study aimed to design a structured measurement instrument to observe and rate the impact of cognitive impairment in daily life, named the cognition in daily life scale for persons with cognitive problems (CDL). In this paper we describe the development, expected usability, and psychometric properties (content and face validity) of the instrument. The CDL was established through three consecutive development phases: (1) item selection, (2) item categorization and comparison, and (3) item revision and manual construction. Subsequently, a panel of eleven international experts rated the relevance of the selected items and provided comments on the expected usability and face validity. Content validity was estimated with the content validity index, based on which four items were removed. The experts' comments led to minor adjustments of the manual, domains, and formulation of the maintained items. The final instrument consists of 65 items describing behaviour that relies on cognitive functions within six domains. Future research should focus on evaluating the construct validity and reliability of the CDL.

Development of an infection control competency scale for clinical nurses: an instrument design study.

BACKGROUND: Nurses work in close proximity to patients, and as such, they can have a direct impact on the control of infections; thus, it is important for nurses to be competent in infection control. However, the scales used to measure infection control performance in nurses are not suitable for measuring infection control competencies that reflect nurses' expertise, clinical environment, and work. Thus, this study aimed to develop a valid and reliable measure to assess infection control competency of clinical nurses. METHODS: A concept analysis, using a hybrid model, was performed on the infection control competency of clinical nurses to confirm the components and develop 67 initial items. Ten experts evaluated the content validity of these items, and a Korean language expert and a Doctor of Nursing reviewed the questions to consolidate them into 59 items. Subsequently, 267 nurses working at a certified tertiary hospital in D City were surveyed to confirm the validity and reliability of the scale. RESULTS: As a result of the study, the final scale comprising seven factors and 33 questions was derived, and the cumulative explanatory power of these factors was 60.8%. To verify convergent and discriminant validity, confirmatory factor analysis was conducted, and the average variance extraction index, composite reliability values, and confidence interval of the correlation coefficient between factors were confirmed. Convergent and discriminant validities were verified by comparison with standard values. The Cronbach's α for the entire scale in this study was 0.93. Consequently, the validity and reliability of the clinical nurses' infection control competency measurement scale were verified. CONCLUSIONS: The validity and reliability of the infection control competency measurement scale for clinical nurses (ICCS-CN) developed in this study was verified, and the scale can be effectively used to measure the infection control competency of clinical nurses. Measuring the infection control competency of clinical nurses will help reduce the harm caused by infection and ensure patient safety by decreasing infection rates in medical institutions.

Cultural translation of the ethical dimension: a study on the reliability and validity of the Chinese nurses' professional ethical dilemma scale.

BACKGROUND: Quantifying the professional ethical challenges that nurses encounter is crucial for both theoretical insights and practical outcomes. The objective of this research is to assess the psychometric properties of the Chinese adaptation of the Moral Distress Scale for Healthcare Professionals (MD-APPS). METHODS: In 2024, a survey approach was utilized to engage with several tertiary-level healthcare institutions throughout China. A cohort of 448 nursing professionals who satisfied the specified selection benchmarks was consequently incorporated into the study. To evaluate the scale's reliability and validity, methods including the Content Validity Index (CVI), Factor Analysis-both Exploratory (EFA) and Confirmatory (CFA)-alongside assessments of internal consistency and test-retest reliability were employed. RESULTS: Expert evaluations yielded an I-CVI of 0.90, suggesting good content validity for the MD-APPS's Chinese adaptation. Exploratory Factor Analysis (EFA) revealed a bi-dimensional framework with 7 components, explaining 56.34% of the cumulative variance. Confirmatory Factor Analysis (CFA) outcomes displayed a χ-square/df ratio of 1.542. The estimate for Robust RMSEA was 0.054, and the SRMR was ascertained to be 0.041. Indices for both Robust TLI and Robust CFI surpassed the 0.9 threshold, indicating an acceptable fit; this aspect was supported by a P-value (Chi-square) of 0.094. The internal consistency, measured by Cronbach's α, was found to be 0.74, while the test-retest reliability over a two-week period reached 0.964. These findings provide initial evidence for the psychometric properties of the Chinese MD-APPS. CONCLUSION: The Chinese adaptation of the MD-APPS demonstrates promising initial psychometric properties, suggesting its potential suitability for exploring nurses' professional ethical challenges within the Chinese cultural context. This scale may facilitate the identification of diverse elements influencing nurses' professional ethics and the assessment of the ethical climate in nursing practices. However, further validation studies are needed to fully establish its psychometric robustness across various healthcare settings in China.

Content validity index for the readiness for hospital discharge scale in the skilled nursing facility setting.

OBJECTIVES: The purpose of this study was to determine the appropriateness of using the Readiness for Hospital Discharge Scale (RHDS) in the skilled nursing facility (SNF) setting as a discharge outcome measure. METHODS: Six experts consisting of nurses and physical therapists from two different SNFs in the Midwest were selected to participate in the study. The content validity of the scale was determined by using item and scale content validity index scores to determine the appropriateness of the scale in the SNF setting. RESULTS: The scale content validity index score for the RHDS was 0.96 with an item content validity index score range of 0.83 to 1.0. Kendall's Coefficient of Concordance was 0.278 and the statistical significance had a p-value of 0.031. CONCLUSIONS: The results of this study indicate that the RHDS has good content validity and is an appropriate measure to determine patient discharge readiness in the SNF setting.

[Establishment and content validity assessment of evaluation index system for development value of traditional Chinese medicine preparations in medical institutions].

The development of traditional Chinese medicine(TCM) preparations as an incubator for new drugs in medical institutions has flourished, while an evaluation index system remains to be established for comprehensively assessing the development value of these prescriptions. This study established an item pool through literature research, employed the Delphi method to determine the content of evaluation indexes, and adopted the superiority chart to determine the weight of each index. Two-level evaluation index system for the development value of TCM preparations in medical institutions was established, which included 7 first-level items and 36 se-cond-level items, demonstrating scientific validity. The first-level items(weight) were inheritance(10.61%), effectiveness(23.22%), safety(22.71%), innovation(13.21%), economy(10.00%), suitability(8.57%), and accessibility(11.68%). The top three second-level items in terms of weight distribution were adverse reaction monitoring(6.73%), evidence of therapeutic effect(5.71%), and clinical response rate(4.75%). The bottom three second-level items were production advantages(0.86%), medicinal dosage(0.48%), and medicinal smell or taste(0.18%). The content validity of the established system was assessed, which revealed that the index system was reliable, with the overall and average content validity indexes of 0.47 and 0.90, respectively. Furthermore, the established evaluation index system was used to evaluate six TCM preparations in a city-level hospital of TCM in Sichuan Province, which demonstrated that the system had operability. The results indicate that the evaluation index system is scientific, reliable, and operable, providing a reference for developers to selectively develop TCM preparations in medical institutions. In practical application, the system can be adjusted regarding the index weights according to actual conditions.