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.

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).

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.

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.

Co-design and content validity of the movement measurement in the early years (MoveMEY) tool for assessing movement behaviour of pre-school aged children.

BACKGROUND: Movement behaviours (physical activity, sedentary behaviour, and sleep) are important for pre-school children's health and development. Currently, no tools with appropriate content validity exist that concurrently capture these movement behaviours in young children. The aim of this study was to co-design and assess the content validity of a novel tool to concurrently measure movement behaviours in pre-school aged children (aged 3-4 years). METHODS: We followed four distinct steps to develop and assess the content validity of Movement Measurement in the Early Years (MoveMEY): (1) We conducted an extensive literature search, to identify pre-existing proxy measurement tools (questionnaires and diaries) to inform the design of a novel tool, which aimed to effectively capture movement behaviour guidelines of pre-school aged children. (2) We facilitated focus group discussions with parents and carers of pre-school aged children (n = 11) and (3) a qualitative survey with free text responses was completed by topic relevant researchers (n = 6), to co-design the measurement tool. (4) We assessed the content validity of the developed tool, MoveMEY, through interviews with parents of pre-school aged children (n = 12) following piloting of the tool. RESULTS: We developed an initial version of MoveMEY based on the format of an existing questionnaire and by mapping the content of questions to the guidelines. Co-design of MoveMEY resulted in changes to the format (e.g. short questionnaire to a seven-day diary) and content (e.g. inclusion of 'general information' questions on illness, disabilities and sleep disturbances; question on screen time before bed). Content validity assessment demonstrated that the items of MoveMEY were relevant and comprehensive for the assessment of children's movement behaviours. MoveMEY was felt to be comprehensible, however, parental suggestions were implemented to finalise and improve MoveMEY (e.g. adding examples to questions aiming to detect moderate to vigorous physical activity). CONCLUSION: MoveMEY is the first co-designed measurement tool that has relevance for assessing the movement behaviour guidelines of pre-school aged children. Parent/carer and topic relevant researcher involvement throughout the development process resulted in a seven-day daily reported activity diary that is comprehensive of children's movement behaviours and comprehensible to parents and carers.

The Feasibility and Validity of Preference-Based Quality of Life Measures With Informal Carers: A Think-Aloud Study.

OBJECTIVES: A range of preference-based quality of life (QoL) measures have been proposed for use with informal carers. Qualitative evaluation of validity and feasibility of the measures is an important step in understanding whether measures will work as intended. At present, little is known about the performance of different types of preference-based QoL measures with informal carers. The objective of this study was to qualitatively assess the feasibility, content validity (including face validity), and acceptability of 5 QoL measures (the Carer Experience Scale, CarerQoL-7D, ASCOT-C, ICECAP-A, and EQ-5D-5L) with informal carers. METHODS: A total of 24 "think-aloud" interviews were conducted with a cross-section of carers of adults in the United Kingdom. This think-aloud process was followed by semistructured discussion to probe issues of validity and feasibility in more detail. The interview data were transcribed, coded to identify the frequency of errors in completing the QoL measures and thematically analyzed to study the validity, feasibility, and acceptability of the measures. RESULTS: Few errors (3%-7% per item) were identified in completing each of the measures with little distinct pattern. Most participants found the measures to be concise, clear, and relevant. Challenges included relevance, context, time period, missing items, multiple questions, and response options. Informal carers generally expressed a preference for using a care-related QoL measure. CONCLUSIONS: Existing preference-based QoL measures have encouraging validity and feasibility within a mixed sample of informal carers, with minor challenges raised. These challenges ought to be considered, alongside the decision context, when administering QoL measures in this context.

Development of the item pool for the 'WHO-ageism scale': conceptualisation, item generation and content validity assessment.

OBJECTIVES: ageism harms individuals' health and wellbeing and can be costly to societies. Reliable and valid measures that can quantify ageism are critical for achieving accurate data on its global prevalence, determinants and impacts, and to evaluate the effectiveness of interventions to reduce it. Ageism scales exist; however, none have been demonstrated to validly measure ageism in a manner consistent with consensus definitions of the concept (i.e. as manifested in all of stereotypes, prejudices and discrimination), whilst also quantifying ageism against all groups, from a target and perpetrator perspective, and across diverse country settings. Our objective was to develop an item pool to meet this need. METHODS: we completed the conceptualisation, item generation and content validity assessment phases of a new World Health Organisation (WHO) WHO-ageism item pool that aims to measure the multi-dimensional nature of ageism. These phases drew on a review of available evidence, an experts' workshop and structured content validity reviews conducted by experts in scale development and ageism drawn from every world region defined by WHO. RESULTS: our resulting item pool is designed to provide a multi-dimensional measure of ageism against all ages measured from both a perpetration and experienced perspective and that can produce valid and reliable scores within diverse country contexts and comparable scores across these contexts. CONCLUSIONS: our item pool is the first major step in providing a global and comprehensive measure of ageism. Future phases of research will refine the item pool and establish the statistical psychometric properties of the final tool.

A qualitative study to explore the symptoms and impacts of Crohn's disease and to develop the Crohn's Disease Diary.

PURPOSE: To explore symptoms and disease impacts of Crohn's disease and to develop a new patient-reported outcomes (PRO) measure according to industry best practices. METHODS: A conceptual model of relevant symptoms experienced by patients with Crohn's disease was developed following a literature review. Three rounds of combined qualitative semi-structured concept elicitation and cognitive debriefing interviews with 36 patients (≥ 16 years) with Crohn's disease and 4 clinicians were conducted to further explore the most commonly reported and most bothersome symptoms to patients. Interview results were used to update the conceptual model as well as items and response options included in The Crohn's Disease Diary, a new PRO measure. RESULTS: All patients (N = 36) reported abdominal pain, loose or liquid bowel movements, and high or increased frequency of bowel movements, with most reporting these symptoms spontaneously (100%, 92%, and 75%, respectively). All patients reported bowel movement urgency, but 61% reported this symptom only when probed. Most also reported that symptoms impacted activities of daily living, work/school, and emotional, social, and physical functioning (overall, 78%-100%; spontaneously, 79% - 92%). Data regarding core symptoms of Crohn's disease from clinician concept elicitation interviews supported patient data. The 17-item Crohn's Disease Diary assesses core symptoms and impacts of Crohn's disease over 24 h, and extraintestinal manifestations over 7 days. The content validity of the diary was confirmed during cognitive debriefing interviews. CONCLUSION: The Crohn's Disease Diary is a new PRO measure for the assessment of Crohn's disease symptoms and impacts, developed according to industry best practices.

Development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0: a qualitative study.

PURPOSE: The Patient and Observer Scar Assessment Scale (POSAS) is widely used for measurements of scar quality. This encompasses visual, tactile and sensory characteristics of the scar. The Patient Scale of previous POSAS versions was lacking input from patients. Therefore, the aim of this study was to develop the POSAS3.0, Patient Scale with involvement of adults patients with all scar types, complying with the highest clinimetric standards. METHODS: From February 2018 to April 2019, a series of six focus group interviews were performed in the Netherlands and Australia to identify scar quality characteristics that adults with scars consider to be important. All focus groups were transcribed, anonymized and analysed using a thematic analysis. Relevant characteristics were formulated into items, resulting in a Dutch and English version of the Patient Scale. These drafts were pilot tested in Australia, the Netherlands and the United Kingdom, and refined accordingly. RESULTS: A total of 21 relevant scar quality characteristics were identified during the focus groups. Two distinct versions of the POSAS3.0, Patient Scale were developed. The Generic version contains 16 items and can be used for all scar types, except linear scars. The Linear Scar version of the Patient Scale contains the same 16 items, with an extra item referring to the widening of scar margins. All included items are rated on a verbal rating scale with five response options. CONCLUSION: Two versions of the POSAS3.0 Patient Scale were developed. Further field tests are being performed to establish the measurement properties and scoring algorithm of the scales.

Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth.

PURPOSE: The aim of this study was to generate evidence supporting the development and content validity of a new PRO instrument, the Small Intestinal Bacterial Overgrowth (SIBO) Symptom Measure (SSM) daily diary. The SSM assesses symptom severity in SIBO patients, with the ultimate goal of providing a fit for purpose PRO for endpoint measurement. METHODS: Qualitative research included 35 SIBO patients in three study stages, using a hybrid concept elicitation (CE)/cognitive interview (CI) method with US patients, ≥ 18 years. Stage 1 included a literature review, clinician interviews, and initial CE interviews with SIBO patients to identify symptoms important to patients for inclusion in the SSM. Stage 2 included hybrid CE/CI to learn more about patients' SIBO experience and test the draft SSM. Finally, stage 3 used CIs to refine the instrument and test its content validity. RESULTS: In stage 1 (n = 8), 15 relevant concepts were identified, with items drafted based on the literature review/clinician interviews and elicitation work. Within stage 2 (n = 15), the SSM was refined to include 11 items; with wording revised for three items. Stage 3 (n = 12) confirmed the comprehensiveness of the SSM, as well as appropriateness of the item wording, recall period, and response scale. The resulting 11-item SSM assesses the severity of bloating, abdominal distention, abdominal discomfort, abdominal pain, flatulence, physical tiredness, nausea, diarrhea, constipation, appetite loss, and belching. CONCLUSIONS: This study provides evidence supporting the content validity of the new PRO. Comprehensive patient input ensures that the SSM is a well-defined measure of SIBO, ready for psychometric validation studies.