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.

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 CINAHL, 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 (COSMIN) 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". 28 (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.

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 and Content Validation of a Measure to Assess the Parent-Child Social-emotional Reciprocity of Children with ASD.

Background: As no scales are currently available to assess the social-emotional reciprocity (SER) between children with autism spectrum disorder (ASD) and their parents, we aimed to develop a questionnaire for this. Methods: Both quantitative and qualitative techniques were used for content validation. All stages of this study used purposive sampling to choose various groups of experts, mental health professionals, and parents of children with ASD to participate in the development, judgment-quantifying, and pretest stages. Data from 30 parents of children with ASD were gathered for the field test. Results: Thirty items were retained after content validation. The proportion of consensus regarding the comprehensiveness of the entire questionnaire was 1.00. The scale-level content validity index (CVI) by averaging calculation method and universal agreement calculation method were 0.95 and 0.50, respectively. Following the pretest, a total of 23 questions, on a five-point scale, were retained. Conclusion: Given the significance of SER between children with ASD and their parents, mental health practitioners should use this questionnaire to understand it to maximize the efficacy of any intervention.

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.

Development and content validity testing of a colonoscopy-specific patient-reported experience measure: the Patient Experience Colonoscopy Scale (PECS).

BACKGROUND: In endoscopic care, favourable patient experiences before, during and after a colonoscopy are essential for the patient's willingness to repeat the procedure. To ensure that significant experiences are measured, patients should be involved in creating the measurement instruments. Thus, the aim of the present study was to develop a colonoscopy-specific PREM by (1) operationalising patient experiences before, during and after a colonoscopy procedure and (2) evaluating its content validity. METHODS: The colonoscopy-specific PREM was developed in two stages: (1) operationalisation with item generation and (2) content validity testing. A previously developed conceptual model, based on a systematic literature review that illustrates patients' (n = 245) experiences of undergoing a colonoscopy, formed the theoretical basis. To assess the degree to which the PREM reflected patients' experiences before, during and after a colonoscopy procedure, content validity was tested-through face validity with healthcare professionals (n = 4) and cognitive interviews with patients (n = 14) having experienced a colonoscopy. Content validity index (CVI) was calculated to investigate the relevance of the items. RESULTS: The Patient Experience Colonoscopy Scale (PECS) is a colonoscopy-specific PREM consisting of five different constructs: health motivation, discomfort, information, a caring relationship and understanding. Each construct was defined and generated into a pool of items (n = 77). After face-validity assessment with healthcare professionals, a draft 52-item version of the PECS was ready for content validity testing by the patients. During cognitive interviews the patients contributed valuable insights that led to rewording and removal of items. Results from the CVI suggest that the PECS and its content are relevant (I-CVI range 0.5-1, S-CVI/Ave = 0.86). The final PECS consists of 30 items representing a colonoscopy-specific PREM. CONCLUSION: The PECS is a new 30-item PREM instrument designed for adult elective colonoscopy patients after they have undergone the procedure. Each item in the PECS derives from a conceptual model based on a systematic literature review. Patients and healthcare professionals were involved in developing the PECS, which measures colonoscopy-specific patient experiences before, during and after the procedure. The content validity testing positively contributed to the development of the PECS. Psychometric properties need to be evaluated further.

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.

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.

Assessing domain match and feasibility of candidate instruments matching with OMERACT endorsed domains to measure flare in knee and hip osteoarthritis.

PURPOSE: To evaluate the domain match (truth) and feasibility of candidate instruments assessing flare in knee and hip osteoarthritis (OA) according to the identified domains. MATERIAL AND METHODS: From a literature review (575 papers), instruments were selected and evaluated using the truth and feasibility elements of the OMERACT Filter 2.2. These were evaluated by 26 experts, including patients, in two Delphi survey rounds. The final selection was obtained by a vote. RESULTS: 44 instruments were identified. In Delphi Round 1, five instruments were selected. In Round 2, all instruments obtained at least 75 % in terms of content match with the endorsed domains and feasibility. In the final selection, the Flare-OA questionnaire obtained 100 % favorable votes. CONCLUSION: Through consensus of the working group, the Flare-OA questionnaire was selected as the best candidate instrument to move into a full assessment of its measurement properties using the OMERACT Filter 2.2.

Content development for a new item-bank for measuring multifocal contact lens performance.

BACKGROUND: Presbyopia is an age-related condition that causes a decreased ability to focus on nearby objects. Multifocal contact lenses are commonly used to address this issue. However, there seems to be a notable dissatisfaction among multifocal contact lens wearers. The absence of a reliable instrument to measure the patient's perspective, despite the widespread use of this method, highlights the need for further research in this area. OBJECTIVE: The objective of this study is to develop an item-bank integrating all domains necessary to assess the patient's perspective on multifocal contact lens performance, offering a comprehensive measure. The item-bank will ensure a high level of content validity, be self-administered, and will initially be available in Spanish. The aim of this tool is to serve as a valuable resource for research and optometric clinics, facilitating the follow-up of patients with presbyopia who wear multifocal contact lenses or those who are newly starting to use them. METHODOLOGY: The MCL-PRO item bank, followed a systematic and step-wise inductive approach to gather information, following the recommendations outlined in the COSMIN guidelines and similar studies. The process involved the following steps: (1) Literature review and relevant existing items identification (2) Social media review, (3) Semi-structured focus groups, (4) performing qualitative analysis, (5) refining and revising the items, and (6) generating the content of the item bank. RESULTS: A total of 575 items were included in the item-bank hosted under 8 different domains that were found to be important for presbyopic population: visual symptoms (213), activity limitation (111), ocular symptoms (135), convenience (36), emotional well-being (33), general symptoms (16), cognitive issues (21) and economic issues (10). CONCLUSION: The item-bank created has followed standardised methodology for its development and encloses all the aspects for MCL performance evaluation from patients perspective.

Evidence to support test interpretation: Evaluating the content validity of a new item set for the Transition Pragmatics Interview.

PURPOSE: There is little consensus on evidence-based practice guidelines for the selection of criterion-referenced assessments. Having confidence in scores from criterion-referenced assessments requires evidence that items align with their intended constructs. The purposes of these studies were to demonstrate evidence of content validity for the revised item set of a developing social communication assessment and to provide clinicians with a model of content validity evaluations that can be generalised to the review of other assessments. METHOD: In Study 1, 10 experts rated 25 newly-developed items for how well they represented the intended construct. In Study 2, seven participants ages 14-20 were administered the Three Step Test Interview to assess their cognitive processes for responding to new items. Examinee responses were coded for construct-relevant and construct-irrelevant factors. RESULT: Twenty-three of the 25 newly-developed items were deemed representative of the intended construct by experts and elicited construct-relevant response processes from examinees. CONCLUSION: The integration of expert review and examinee cognitive interviewing provides a more complete evaluation of the alignment of the items to their intended construct. Transparent reports of the methods and findings of content validity studies strengthen the ability of clinicians to select criterion-referenced assessments that support valid decisions.

Satisfaction with asynchronous e-learning: An exploratory factor analysis of the Learner Satisfaction with Asynchronous e-Learning (LSAeL) instrument.

AIM: To describe the development and psychometric testing of the Learner Satisfaction with Asynchronous e-Learning (LSAeL) instrument. BACKGROUND: Existing satisfaction with e-learning instruments may not accurately evaluate learner satisfaction with constructs associated with asynchronous e-learning. DESIGN: Methodological study. METHODS: Content, face and construct validity of the instrument were evaluated using a two-stage process. A five-member expert panel evaluated the instrument's content and face validity. A content validity index and a modified kappa co-efficient was used to calculate the content validity of individual test items and the global instrument and to adjust for chance agreement between raters. These data were then reviewed and individual items were removed, retained or refined accordingly. Using an empirically informed wholly asynchronous e-learning program 237 nursing students from a regional university in New South Wales, Australia completed the 35 item LSAeL instrument. An exploratory factor analysis (EFA) was then conducted to explore the dimensionality of the instrument. RESULTS: Exploratory factor analysis identified a seven-factor solution with 30 items, explaining an 86.1% of the total variance, was the best fit for the data. CONCLUSION: The study demonstrates that the construct validity of the LSAeL instrument is acceptable. Instrument development is an iterative process and further testing with other cohorts and in other settings is required.

Validating the International Classification of Functioning, Disability and Health Core Sets for Autism in a Sample of Australian School-Aged Children on the Spectrum.

Assessing functioning of children on the autism spectrum is necessary to determine the level of support they require to participate in everyday activities across contexts. The International Classification of Functioning, Disability and Health (ICF) is a comprehensive biopsychosocial framework recommended for classifying health-related functioning in a holistic manner, across the components of body functions, activities and participation, and environmental factors. The ICF Core Sets (ICF-CSs) are sub-sets of relevant codes from the broader framework that provide a basis for developing condition-specific measures. This study combined the ICF-CSs for autism, attention deficit hyperactivity disorder (ADHD) and cerebral palsy (CP) to validate the ICF-CSs for autism in an Australian sample of school-aged children. This cross-sectional study involved caregivers of school-aged children on the spectrum (n = 70) completing an online survey and being visited in their homes by an occupational therapist to complete the proxy-report measure based on the ICF-CSs for autism, ADHD and CP. Absolute and relative frequencies of ratings for each of the codes included in the measure were calculated and reported, along with the number of participants who required clarification to understand the terminology used. Findings indicate that the body functions and activities and participation represented in the ICF-CSs for autism were the most applicable for the sample. However, findings relating to environmental factors were less conclusive. Some codes not currently included in the ICF-CSs for autism may warrant further investigation, and the language used in measures based on the ICF-CSs should be revised to ensure clarity.

Patient-reported outcome measures for dysphagia in head and neck cancer: A systematic review and appraisal of content validity and internal structure.

Dysphagia is a major head and neck cancer (HNC) issue. Dysphagia-related patient-reported outcome measures (PROMs) are critical for patient-centred assessment and intervention tailoring. This systematic review aimed to derive a comprehensive inventory of HNC dysphagia PROMs and appraise their content validity and internal structure. Six electronic databases were searched to February 2023 for studies detailing PROM content validity or internal structure. Eligible PROMs were those developed or validated for HNC, with ≥20% of items related to swallowing. Two independent raters screened citations and full-text articles. Critical appraisal followed COSMIN guidelines. Overall, 114 studies were included, yielding 39 PROMs (17 dysphagia-specific and 22 generic). Of included studies, 33 addressed PROM content validity and 78 internal structure. Of all PROMs, only the SOAL met COSMIN standards for both sufficient content validity and internal structure. Notably, the development of 18 PROMs predated the publication of COSMIN standards. In conclusion, this review identified 39 PROMs addressing dysphagia in HNC, of which only one met COSMIN quality criteria. Given that half of PROMs were developed prior to COSMIN guidelines, future application of current standards is needed to establish their psychometric quality.

Content analysis of AI-generated (ChatGPT) responses concerning orthodontic clear aligners.

OBJECTIVES: To assess the accuracy of ChatGPT answers concerning orthodontic clear aligners. MATERIALS AND METHODS: A cross-sectional content analysis of ChatGPT generated responses to queries related to clear aligner treatment (CAT) was undertaken. A total of 111 questions were generated by three orthodontists based on a set of predefined domains and subdomains. The artificial intelligence (AI)-generated (ChatGPT) answers were extracted and their accuracy was determined independently by five orthodontists. The accuracy of answers was assessed using a prepiloted four-point scale scoring rubric. Descriptive statistics were performed. RESULTS: The total mean accuracy score for the entire set was 2.6 ± 1.1. It was noted that 58% of the AI-generated answers were scored as objectively true, 18% were selected facts, 9% were minimal facts, and 15% were false. False claims included the ability of CAT to reduce the need for orthognathic surgery (4.0 ± 0.0), improve airway function (3.8 ± 0.5), achieve root parallelism (3.6 ± 0.5), alleviate sleep apnea (3.8 ± 0.5), and produce more stable results compared to fixed appliances (3.8 ± 0.5). CONCLUSIONS: The overall level of accuracy of ChatGPT responses to questions concerning CAT was suboptimal and lacked citations to relevant literature. Ability of the software to offer current and precise information was limited. Therefore, clinicians and patients must be mindful of false claims and relevant facts omitted in the answers generated by ChatGPT.

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.

Qualitative Research to Understand the Patient Experience and Evaluate Content Validity of the Chronic Ocular Pain Questionnaire (COP-Q).

INTRODUCTION: Chronic ocular surface pain (COSP) is described as a persistent, moderate-to-severe pain at the ocular surface lasting more than 3 months. Symptoms of COSP have a significant impact on patients' vision-dependent activities of daily living (ADL) and distal health-related quality of life (HRQoL). To adequately capture patient perspectives in clinical trials, patient-reported outcome (PRO) measures must demonstrate sufficient evidence of content validity in the target population. This study aimed to explore the patient experience of living with COSP and evaluate content validity of the newly developed Chronic Ocular Pain Questionnaire (COP-Q) for use in COSP clinical trials. METHODS: Qualitative, combined concept elicitation (CE) and cognitive debriefing (CD) interviews were conducted with 24 patients experiencing COSP symptoms in the USA. Interviews were supplemented with real-time data collection via a daily diary app task in a subset of patients (n = 15) to explore the day-to-day patient experience. Three healthcare professionals (HCPs) from the USA, Canada, and France were also interviewed to provide a clinical perspective. CE results were used to further inform development of a conceptual model and to refine PRO items/response options. CD interviews assessed relevance and understanding of the COP-Q. Interviews were conducted across multiple rounds to allow item modifications and subsequent testing. RESULTS: Eye pain, eye itch, burning sensation, eye dryness, eye irritation, foreign body sensation, eye fatigue, and eye grittiness were the most frequently reported symptoms impacting vision-dependent ADL (e.g., reading, using digital devices, driving) and wider HRQoL (e.g., emotional wellbeing, social functioning, work). COP-Q instructions, items, and response scales were understood, and concepts were considered relevant. Feedback supported modifications to instruction/item wording and confirmed the most appropriate recall periods. CONCLUSIONS: Findings support content validity of the COP-Q for use in COSP populations. Ongoing research to evaluate psychometric validity of the COP-Q will support future use of the instrument in clinical trial efficacy endpoints.

Development and Validation of an Auricular Acupuncture Protocol for the Management of Chemotherapy-Induced Nausea and Vomiting in Cancer Patients.

Auricular acupuncture (AA) has been used to manage chemotherapy-induced nausea and vomiting (CINV). However, the application of the technique varies widely among the clinical trials that test its effectiveness. The aim of the present study was to develop and clinically validate an AA protocol for the management of CINV in cancer patients. This study was carried out in two stages: (1) development of the AA protocol for the management of CINV and (2) clinical validation of the protocol. The content validity of the protocol was determined by a panel of specialists, with an agreement rate ranging from 85.7% to 100%. In the clinical validation, when administered to cancer patients, the protocol developed has been shown to reduce the incidence, frequency, severity, and length of nausea and vomiting following chemotherapy, as well as the severity of nausea and anticipatory nausea following chemotherapy. This protocol needs to be tested in future studies, including a pilot study with a sham group and a randomized clinical trial, in order to further evaluate its feasibility, acceptability, safety, and clinical usefulness for the management of CINV.

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.

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.