Content validation of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (NFLymSI-18) in indolent B-cell non-Hodgkin's lymphoma.

BACKGROUND: The NFLymSI-18 is a patient-reported outcome measure comprised of the highest priority symptoms, emotional concerns, treatment side effects, and other concerns identified by lymphoma patients and oncologists. This study assessed the content validity of the NFLymSI-18 for patients with indolent B-cell non-Hodgkin's lymphoma (iNHL), with a focus on the Disease-Related Symptoms Physical (DRS-P) subscale. METHODS: Patients with a confirmed iNHL diagnosis who had received one or more lines of treatment were recruited during clinic visits. Patients described their symptoms, treatment side effects, and emotional concerns related to iNHL in a semi-structured interview. Qualitative data were analyzed using NVivo10. RESULTS: Data saturation was obtained by the 18th interview. Most participants (67%) had follicular lymphoma. 28% of participants had marginal zone lymphoma, and one participant had lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia. Mean age of the 18 participants was 67 years. 56% of the sample was male. Most participants (67%) had a college or advanced degree. When asked to describe their iNHL symptoms, patients most often discussed swelling (n = 14), fatigue (n = 11), and pain (n = 8). The following symptoms were mentioned by three patients each: anxiety, appetite loss, rash, sleep disruption, trouble breathing, and malaise. Mapping of NFLymSI-18 content to these concerns showed the instrument includes all those most frequently mentioned symptoms. CONCLUSIONS: This study supports the content validity of the NFLymSI-18, including its DRS-P Subscale, for patients with iNHL. The instrument shows strong validity for the most referenced symptoms of swelling, fatigue, and pain. The diversity of additional symptoms reported by patients is consistent with the heterogeneous symptomology of iNHL.

Development of a Vitamin B12 Deficiency Patient-Reported Outcome Measure for Clinical Practice and Research.

BACKGROUND: It is difficult to recognize vitamin B12 deficiency and to evaluate the effect of B12 treatment due to a broad range of variable clinical symptoms overlapping with other diseases and diagnostic biomarkers that quickly normalize during treatment. This poses a risk of delay in diagnosis and a challenge to uniformly monitor the effect of B12 treatment. There is a need for a new clinical outcome measure suitable for clinical practice and clinical evaluation studies. OBJECTIVE: To develop a Patient-Reported Outcome Measure (PROM) which measures the severity of vitamin B12 deficiency symptoms. METHODS: The B12 PROM was developed by (1) gathering input from experts and literature review to define a construct and develop a conceptual model, (2) processing input from health care providers, scientists, and patients to develop items and response options, and (3) improving items based on the feedback from laypersons, test interviews, semi-structured cognitive interviews with patients, and forward and backward translation (ENG-NL). RESULTS: The B12 PROM includes 62 items grouped into 8 categories of symptoms related to vitamin B12 deficiency (General, Senses, Thinking, In limbs and/or face, Movement, Emotions, Mouth & Abdomen, Urinary tract & Reproductive organs). Cognitive interviews demonstrated good comprehensibility and comprehensiveness. CONCLUSIONS: This study is the first step in the development of a disease-specific PROM for vitamin B12 deficiency to measure the burden of symptoms. Further validation and reliability testing are necessary before the PROM can be applied in clinical practice and research.

Plain language titleDevelopment of a Vitamin B12 Deficiency Questionnaire for Clinical Practice and ResearchPlain language summaryThis study is the first step in the development of a questionnaire for vitamin B12 deficiency to measure the severity of vitamin B12 deficiency symptoms. The questionnaire includes 62 items grouped into 8 categories of symptoms related to vitamin B12 deficiency (General, Senses, Thinking, In limbs and/or face, Movement, Emotions, Mouth & Abdomen, Urinary tract & Reproductive organs). Interviews with patients demonstrated good comprehensibility and comprehensiveness of the questionnaire. Further testing is necessary before the questionnaire can be applied in clinical practice and research.

Development of an Instrument to Assess Health and Social Care Professionals' Knowledge and Attitudes Towards Later-Life Intimacy and Sexuality (HSCP-KALLIS): A Delphi Study.

AIMS: We aimed to ascertain the content validity of an instrument to assess health and social care professionals' knowledge and attitudes towards later-life intimacy and sexuality (HSCP-KALLIS). BACKGROUND: For older adults, intimacy and sexuality are important in maintaining their quality of life and well-being. However, addressing these needs remains challenging for health and social care professionals, particularly for nursing staff providing 24-h direct care to older people with dementia or those identified as lesbian, gay, bisexual, transgender, intersex or queer/questioning individuals. Existing instruments assessing knowledge and attitudes towards later-life intimacy and sexuality are dated and fail to adequately address dementia and sexual diversity. DESIGN: A two-round modified Delphi study was conducted. METHODS: Initially, 79 knowledge and attitude items were generated through an integrative review. Panellists rated each item's clarity and importance using online questionnaires. The content validity index for the individual and overall items was calculated. The panellists' written feedback-along with their knowledge level of later-life intimacy and sexuality-was obtained. RESULTS: Panellists included health and social care professionals (n = 9); healthcare-related educators (n = 2); researchers specialising in later-life intimacy, sexuality, dementia care and sexual diversity support (n = 7); and family carers of older people with dementia (n = 2). The instrument was revised based on the feedback received. The components of dementia, LGBTIQ+ and the provision of sex worker services in healthcare settings were highlighted by the panellists. Notably, 46 knowledge and 40 attitude items fulfilled the consensus criteria for clarity and importance. CONCLUSIONS: Acceptable content validity was established for the knowledge and attitude items. Further research is required to establish the psychometric properties of the HSCP-KALLIS. This instrument has implications for clinical practice-specifically, in nursing care-by addressing issues to improve awareness regarding later-life intimacy and sexuality in healthcare settings. IMPLICATIONS FOR PRACTICE: The HSCP-KALLIS has the potential to inform the educational needs regarding knowledge and attitudes towards later-life intimacy and sexuality for health and social care professionals, specifically nursing staff. The findings of the HSCP-KALLIS can be used for the development of competencies for later-life intimacy and sexuality, establishing policies and guidelines to support older adults' intimacy and sexuality needs in health care settings.

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.

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.

Clinical validation of the nursing diagnosis "Fall risk in adults (00303)" in elderly people in the community-dwelling.

PURPOSE: To identify the risk factors for the nursing diagnosis of fall risk in adults (00303) in elderly people in the community-dwelling. METHOD: This is a methodological study, with a quantitative approach, carried out with elderly people living in the city of Ribeirão Preto, SP, Brazil, from February to December 2018. For data collection, the demographic profile, Mini-Mental State Examination, diseases self-reported, functional independence measure, Lawton and Brody scale, geriatric depression scale, and self-perception of gait instruments were used. Tests of accuracy and association of risk factors with p ≤ 0.05 were performed. FINDINGS: A total of 262 elderly people, aged over 80 years (55.7%), 71% of which were female and 42.7% were widowed, were included in the sample. A total of 82.1% had vascular diseases, 72.1% had diabetes, and 20.6% had depression. The predominant risk factors were difficulty performing instrumental activities of daily living (58.8%), cognitive dysfunction (43.5%), and depressive symptoms (26.3%). Difficulty performing instrumental activities of daily living had a sensitivity greater than 60%. The positive and negative predictive values were mostly greater than 50%. In the regression analysis, it was found that the elderly have a higher risk of suffering a fall if they present anxiety (p = 0.05), impaired physical mobility (p = 0.02), and difficulty to perform instrumental activities of daily living as risk factors (p = 0.03). CONCLUSION: It was possible to identify the presence of risk factors for the diagnosis fall risk in adults (00303) in the clinical context of the elderly in home settings and contribute to the clinical validation of the taxonomy, increase the evidence and importance of the diagnosis, and generate new knowledge for gerontological nursing. IMPLICATIONS FOR NURSING PRACTICE: To help nurses identify risk factors that lead elderly people to suffer falls at home and to implement preventive actions in their community with the support of their families.

OBJETIVO: Identificar os fatores de risco para o diagnóstico de enfermagem Risco de Quedas em adultos (00303) em idosos do domicílio. MÉTODO: Trata­se de um estudo metodológico, com abordagem quantitativa, realizado com idosos residentes na cidade de Ribeirão Preto, SP, Brasil, no período de fevereiro a dezembro de 2018. Para coleta de dados foram utilizados instrumentos de perfil sociodemográfico, Mini exame do Estado Mental, doenças autorreferidas, Medida de Independência Funcional, Escala de Lawton e Brody, Escala de Depressão Geriátrica e autopercepção da marcha. Foram realizados testes de acurácia e associação de fatores de risco com p ≤ 0,05. RESULTADOS: Participaram 262 idosos, com idade superior a 80 anos (55,7%), sendo 71% do sexo feminino e 42,7% viúvos. Um total de 82,1% tinha doenças vasculares, 72,1% tinham diabetes e 20,6% tinham depressão. Os fatores de risco predominantes foram dificuldade para realizar atividades instrumentais de vida diária (58,8%), déficit cognitivo (43,5%) e sintomas depressivos (26,3%). A dificuldade para realizar atividades instrumentais da vida diária apresentou sensibilidade superior a 60%. Os valores preditivos positivos e negativos foram em sua maioria superiores a 50%. Na análise de regressão constatou­se que os idosos apresentam maior risco de sofrer queda se apresentarem Ansiedade (p = 0,05), Mobilidade física prejudicada (p = 0,02) e Dificuldade para realizar atividades instrumentais de vida diária (p = 0,03). CONCLUSÃO: Foi possível identificar a presença de fatores de risco para o diagnóstico Risco de queda em adultos (00303) no contexto clínico do idoso em ambiente domiciliar e contribuir para a validação clínica da taxonomia, aumentar a evidência e a importância do diagnóstico e gerar novos conhecimentos para a enfermagem gerontológica. IMPLICAÇÕES PARA A PRÁTICA DE ENFERMAGEM: Ajudar os enfermeiros a identificar os fatores de risco que levam os idosos a sofrer quedas no domicílio e a implementar ações preventivas na sua comunidade com o apoio dos seus familiares.

Transition of care in a Danish context: translation, cross-cultural adaptation and content validation of CTM-15 and PACT-M.

BACKGROUND: Transition of care from hospitalisation to home is a complex process with potential patient safety risks, especially for patients with multimorbidity. Traditionally, the quality of transition of care has been evaluated primarily through readmission rates. However, interpreting the readmission rates presents challenges, and readmission rates fail to capture the patient's perspective on the quality of the care transition. Insight into the patient's experience with their care or a health service can be provided through the use of patient-reported experience measures (PREMs), and the two PREMs Care Transitions Measure 15 (CTM-15) and Partners at Care Transitions Measure part 1 and 2 (PACT-M1 and PACT-M2) assess on the quality of transition of care from the patients' perspective. The aim of this study was to translate, culturally adapt, and assess content validity of CTM-15, PACT-M1, and PACT-M2 for Danish-speaking patients with multimorbidity. METHODS: A two-step approach was used for content validation, involving cognitive debriefing and interviews with patients, representing the target group, as well as quantitative data collection from healthcare professionals representing all three sectors of the Danish healthcare system. The patients were systematically interviewed regarding the aspects of content validity; comprehensibility, relevance, and comprehensiveness. The healthcare professionals assessed the relevance and comprehensiveness of each item through questionnaires, allowing the calculation of a content validity index (CVI). An item CVI ≥ 0.78 is considered good. RESULTS: The results of the qualitative data indicated that both CTM-15 and the PACT-M questionnaires were considered relevant, and comprehensible, and comprehensive to the target group. The CVI computed at item level determined that PACT-M1 and PACT-M2 demonstrated excellent content validity among the healthcare professionals, whereas the CVI for two items of the CTM-15 fell below the threshold value for "good". CONCLUSION: The Danish versions of the PACT-M questionnaires demonstrated good content validity, and the CTM-15 demonstrated acceptable content validity based on qualitative data from patients and quantitative data from healthcare professionals. Further validation of the questionnaires, by assessing their construct validity and reliability is recommended.

In this study, we aimed to translate two questionnaires, CTM-15 and PACT-M, that address patients' perspectives on the quality of transition of care, into Danish. Furthermore, we assessed their content validity i.e., their relevance, comprehensibility, and comprehensiveness. The study is important because we need to include the patients' experiences in the overall evaluation of transition of care from hospital admission to home. This is possible through validated questionnaires. In order to investigate the content validity, it is important to include representatives of the target group, in this study patients with multimorbidity, as well as professional experts in the area. We interviewed patients about their perception of the relevance, comprehensibility, and comprehensiveness of the questionnaires. Additionally, we asked healthcare professionals about the relevance and comprehensiveness of the questionnaires. PACT-M demonstrated good content validity according to both patients and healthcare professionals. CTM-15 showed good content validity among patients, however, two items were not considered relevant by healthcare professionals. To ensure the usability of the questionnaires, further investigation into their construct validity, reliability, and responsiveness is necessary. Upon completion of the validation process, the questionnaires will be valuable tools in research projects aiming to improve the transition of care, as well as in quality monitoring and improvement initiatives.

Development and validation of a healthy diet and physical activity tool based on health action process approach among patients undergone bariatric surgery.

Background: The purpose of this study was to develop and evaluate the validity and reliability of a healthy diet and physical activity assessment tool among patients one year after bariatric surgery based on Health Action Process Approach. Methods: We compiled 53 items based on healthy diet and physical activity behaviors among patients undergone bariatric surgery through reviewing the literature. Using quantitative and qualitative methods, and a panel of experts, we evaluated the face and content validities of the tool. The reliability was evaluated by Intra-class correlation coefficient and Cronbach's alpha. Results: The content validity ratio and the content validity index were 0.62 and 0.79, respectively. Exploratory factor analysis showed seven factors, including risk perception, outcome expectations, task self-efficacy, coping, recovery self-efficacy, action planning, coping planning, and behavioral intentions. The Intra-class correlation coefficient was between 0.8 and 0.91; and Cronbach's alpha for different constructs was between 0.8 and 0.95. Conclusion: The findings showed that the constructs of the Health Action Process Approach tool regarding healthy diet and physical activity had adequate validity and reliability in bariatric surgery patients.

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.

Content Validity and Psychometric Properties of the German Version of the Holm and Cordoba Urinary Tract Infection Score for Uncomplicated Urinary Tract Infections in Women: Protocol for a Validation Study.

BACKGROUND: Uncomplicated urinary tract infections (UTIs) in women are among the most common bacterial infections in primary care. Given the health threats related to the overuse of antibiotics, alternative options are of increasing importance. Patient-reported outcome measures are valuable tools for including the patients' perspective when evaluating the efficacy of these strategies. Aiming to identify a suitable instrument to measure the severity and bothersomeness of UTI symptoms in women, we performed a systematic review of the literature and identified the Holm and Cordoba Urinary Tract Infection Score (HCUTI), which measures the severity, bothersomeness, and impact of uncomplicated UTIs on daily activities. This instrument showed sufficient content validity but needs translation and further validation before it can be used in German research. OBJECTIVE: For use in the German setting, we aim (1) to perform translation and linguistic validation of the HCUTI and (2) to evaluate content validity and psychometric properties of the German version of the HCUTI in a population of women with uncomplicated UTIs. METHODS: The HCUTI will be translated and linguistically validated using the dual-panel method. This process involves a bilingual translation panel and a lay panel to check the comprehensibility of the translation. Content validity of the translated questionnaire will be assessed using cognitive interviews according to the criteria for good content validity as recommended by the COSMIN (Consensus-based Standards for the selection of health Measurement Instruments) group involving women with uncomplicated UTIs and health care professionals. Subsequent psychometric validation of the German version of the HCUTI in a population of women with uncomplicated UTIs will include the assessment of structural validity, internal consistency, test-retest reliability, construct validity, responsiveness, and interpretability. RESULTS: Results of the translation and linguistic validation process and the results of the content validity study were obtained in September 2023 and will be published separately. Data on the psychometric properties of the German version of the HCUTI are anticipated in mid-2024. CONCLUSIONS: We expect that data from the content validity study will provide important suggestions for potential modifications of the HCUTI for use in the German setting. The final version of the questionnaire will be used for the assessment of its psychometric properties in a large population of women with uncomplicated UTIs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/49903.

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.

Usefulness of Current Patient-Reported Outcome Scales for ACL Injury: A Mixed-Methods Evaluation of Stakeholder-Perceived Utility of Specific Constructs and Items Across the Rehabilitation Timeline.

Background: Numerous patient-reported outcome measures (PROMs) have been used in patients with anterior cruciate ligament reconstruction (ACLR), often with overlapping constructs of interest and limited content validity. Inefficient scale application increases burden and diminishes overall usefulness for both the patient and practitioner. Purpose: To isolate specific PROM items across a diverse set of constructs that patients and practitioners perceive as having the greatest value at various stages of recovery and return to sport (RTS) in patients after ACLR. Study Design: Cross-sectional study. Methods: A combined 77 stakeholders participated in this 2-phase mixed-methods investigation. In phase 1, a total of 27 patients and 21 practitioners selected individual PROM items from various constructs that had the greatest utility or importance. In phase 2, the highest rated items were further tested in a head-to-head comparison with 29 stakeholders who attended the 2022 ACL Injury Research Retreat. In addition to the utility assessment, practitioners answered other questions related to importance and timing of PROM assessments. Results: In phase 1, both patients and practitioners shared the same top item in 6 of the 8 (75%) constructs assessed. In phase 2, the construct of psychological burden was rated as "extremely important" by 59% of respondents, followed by physical function (54%), symptoms (35%), and donor site issues (10%). The PROM items of confidence, perceived likelihood of reinjury, and difficulty stopping quickly were rated by a respective 93%, 89%, and 86% of the sample as either "very useful" or "extremely useful." All constructs except donor site issues were rated by most stakeholders to be absolutely necessary to evaluate treatment progress and RTS readiness at the 6-month postoperative time and at RTS. Conclusion: Overall, psychological burden, with specific items related to confidence and reinjury likelihood, were rated as most important and useful by both patients and practitioners. The second most important and useful PROM item was related to higher intensity function (eg, decelerating or jumping/landing activities during sports).

Validating a theory of planned behavior questionnaire for assessing changes in professional behaviors of medical students.

Introduction: Teaching professionalism is a fundamental aspect of medical undergraduate education, delivering important domains of professional attitudes, ethics, and behaviors. The effects of educational interventions can be assessed by measuring the change in such domains, but validated assessment tools for these professionalism domains are lacking. In this study, we constructed and conducted expert validation of a modified theory of planned behavior (TPB) questionnaire to assess changes in professional behaviors (PBs) in medical students. Methods: To validate that, we modified an existing TPB questionnaire, and an 18-item questionnaire was subjected to expert panel evaluation using the content validation method. The clarity and relevance of items were assessed using a four-point rating scale (i.e., 1 = not relevant to 4 = highly relevant). Ratings of experts and free-text comments were analyzed. Quantitative evaluation of relevance and clarity was undertaken through analyses of the Item-level Content Validity Index (I-CVI) and Scale-level Content Validity Index (S-CVI). A qualitative assessment of the comments of experts was conducted to refine items, any disagreements were discussed, and a consensus decision was developed among authors for item changes. Results: Quantitative evaluation of the Item-level Content Validity Index (I-CVI) scored 0.9-1 for relevance and 0.7-1 for clarity. Qualitative evaluation resulted in (i) changes to the wording of items (e.g., choices such as "worthless/worthwhile" were replaced with "not important/important"); and (ii) suggestion of the addition of social media in the construct of subjective norms. Discussion: The proposed tool exhibits content validity and can assess TPB constructs in professionalism education. This study of content validity may help to ensure the modified TPB questionnaire accurately measures the TPB constructs, ensuring its effectiveness in accurately measuring the TPB constructs for PB in diversified educational medical institutions.

Validating the Antismoking AIDA Model-Based Questionnaire for Malaysian Population.

INTRODUCTION: The aim of this study was to validate the AIDA (Attention, Interest, Desire, and Action) Model-Based Antismoking Campaign Questionnaire to be used in Malaysian population. METHOD: This study consists of mainly translation, validation, and pilot testing. The translation phase using forward and backward translation, involved three panels and three translators. The validation was a cross-sectional study conducted from May to July 2023 with a purposive sampling technique. The data was collected through e-mails among eight experts. These experts answered an online questionnaire on a four-option Likert scale, based on the four concepts of relevancy, clarity, comprehensiveness, and representativeness. The content validity index (CVI) was measured on the scale of the content validity index (S-CVI/Ave) and Universal Agreement (UA). For pilot testing, the final version was tested among 25 non-smokers and six smokers to determine its reliability using the Cronbach's alpha. RESULTS: The content validity study for relevancy, clarity, comprehension, and representative S-CVI/Ave is 0.85, 0.79, 0.79, and 0.84, respectively. The CVI score of above 0.83 indicates all items are relevant and representable. The pilot testing shows high internal consistency for both samples, more than 0.85. CONCLUSION: In summary, the adapted translated version's content validity index was satisfactory, and it can be further pilot tested among the other target population.

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.

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.

Rapid Blueprinting: An Efficient Method for Designing Content of Assessments.

Problem: Many assessments in medical education involve measuring proficiency in a content area. Thus, proper content development (blueprinting) of tests in this field is of primary importance. Prior efforts to conduct content review as part of assessment development have been time- and resource-intensive, relying on practice analysis and then on linking methods. This monograph explores a "rapid, cost-effective" approach to blueprinting that allows efficient assessment development with rigor. Our investigation seeks to explore an efficient and effective alternate method for creating a content design (blueprint) for medical credentialing and evaluation examinations by focusing directly on assessment requirements. Approach: We employed a two-phase process to propose a rapid blueprinting method. Phase 1 involved a 1-day direct meeting of content experts/practitioners. Phase 2 involved a corroboration survey sent to a wider group of content experts/practitioners. The rapid blueprinting method was applied to developing eleven blueprints (five for medical specialty certification; five for health professions certification; and one for in-training assessment). Outcomes: The methods we used resulted in effective, well-balanced, operational examinations that successfully implemented the resulting blueprints in item writing assignments and test development. Assessments resulting from the use of the rapid blueprinting method also generated psychometrically sound inferences from the scores. For example, the assessments resulting from this methodology of test construction had KR-20 reliability coefficients ranging from .87 to .92. Next Steps: This approach leveraged the effectiveness and feasibility of the rapid blueprinting method and demonstrated successful examination designs (blueprints) that are cost- and time-effective. The rapid blueprinting method may be explored for further implementation in local assessment settings beyond medical credentialing examinations.

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.

Knowledge, Awareness, and Practice of Safety and Emergency Response Among Scuba Divers in Malaysia: Questionnaire Development and Validation.

INTRODUCTION: Safety has become paramount to ensure that scuba diving continues to expand into new markets, with minimal risks, and that scuba diving translates into a safe and relaxed adventure in response to growing market demands. Research focusing on assessing the knowledge, awareness, and practices (KAP) regarding safety and emergency response among scuba divers has been limited, and there is a need for validated assessment tools in this area. METHODS: This study involved 555 scuba divers in Malaysia, and the questionnaire underwent a thorough development and validation process, including content and face validity assessments, as well as exploratory factor analysis. The validation of the knowledge domain was conducted using Item Response Theory (IRT) analysis, while awareness and practice were validated through exploratory and confirmatory factor analyses (EFA and CFA). RESULTS: The content validity of the instrument was confirmed, with all items scoring over 80% for Item Content Validity Index (I-CVI), Scale Content Validity Index (S-CVI), and Scale Content Validity Index/Average (S-CVI/AVE). The initial draft comprises three domains: knowledge, awareness, and practice. Knowledge items were analyzed using IRT and demonstrated acceptable difficulty and discrimination levels. For the awareness and practice domains, EFA showed a Kaiser-Meyer-Olkin measure (KMO) of 0.83 and 0.79, respectively, with a significant Bartlett's test of Sphericity (P < 0.001). EFA yielded three factors for both awareness and practice domains with a total of 12 items for awareness and 13 items for practice, with satisfactory factor loadings (≥0.3). The final model of CFA showed good fits for both awareness and practice domains in terms of absolute, parsimonious, and comparative measures. The composite reliability of awareness was acceptable with Raykov's rho of 0.71, whereas the practice domain fell slightly below the acceptable threshold at 0.55. This was attributed to low factor loading and a limited number of items within each factor. The final questionnaire now consists of 20 items for knowledge, 10 items for awareness, and 12 items for the practice domain. CONCLUSION: The results of this validation and reliability study indicate that the newly developed questionnaire possesses favorable psychometric properties for assessing KAP related to safety and emergency response in the scuba diving context. This research is essential for harmonizing the perspectives of crucial stakeholders within the recreational scuba diving industry.

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.