Cross-cultural adaptation and validation of the 2021 Louisiana Needs Assessment Questionnaire for Arabic-speaking people living with HIV.

BACKGROUND: Despite the global decline in HIV infections and mortality worldwide, the HIV epidemic is still growing in the MENA region. In the region, People Living with HIV (PLWH) are facing many challenges related to cultural values, norms, and provided services which create significant obstacles to HIV prevention and control efforts. This study aimed to translate, culturally adapt, and validate the "2021 Louisiana Needs Assessment Questionnaire" for use among Egyptians and Arabic-speaking population. METHODS: Arabic translation and cultural adaptation of the questionnaire passed through five stages. The questionnaire was translated forward and backward then an expert committee reviewed the translated version. Another expert committee reviewed the developed version after modification to assess the content validity using the Content Validity Index (CVI). The last step included a cognitive interview of a convenient sample of 50 adult PLWH in five consecutive rounds to assess subjects' understanding of questions and response items and their meanings. RESULTS: Modifications were carried out all through the translation and adaptation process of the questionnaire including used words, nomenclature of services, adding or omitting response items, and ordering of questions and response items. The synthesized Arabic-adapted questionnaire has adequate content validity and all questions are clearly understood by the studied subjects. The calculated Content Validity Index of all questionnaire items ranged from 0.82 to 1. CONCLUSION: The developed culturally adapted questionnaire has adequate content validity/semantic appropriateness. It can be used to assess the needs of PLWH in the MENA region with minor adaptations to fit each country. It can also be used to follow the outcome and impact of implemented programs and services. Further research is recommended to assess its psychometric properties.

Important aspects of experiences from patients and parents related to medications in Child and Adolescents Mental Health Services (CAMHS) - a qualitative study.

PURPOSE: Patient-reported experiences are a key source of information on quality in mental health care. Most patient experience surveys are limited to assessments from adults, including those conducted by parents or proxies on behalf of others. The aim of this study was to produce findings to inform development of modules on patient and parent experiences with medication in outpatient CAMHS in Norway, for use in previously validated instruments applied in national surveys. PATIENTS AND METHODS: We developed survey questions based on a systematic literature review, expert-group consultations, interviews with adolescents and parents, and pretesting of the modules in a pilot study. This study included adolescents aged 12-17 years and parents with experiences from outpatient CAMHS and we present findings from semi-structured interviews. RESULTS: Adolescents with ADHD emphasized the following aspects as important concerning medication use in CAMHS: positive effects of medication like better function and concentration in school and change of behaviour. They also stressed the importance of side effects such as eating problems, nausea, loss of appetite, insomnia, and changes in thoughts and feelings. In addition, adolescents highlighted the significance of aspects as support in daily routines for taking medications, while parents highlighted needs for a professional follow-up care. Parents emphasized aspects regarding their children's medication included both positive effects and change in behaviour, as well as their identification of negative side effects. CONCLUSION: Our findings from semi-structured interviews identified important aspects reported by both patients and parents on functions, side effects and follow-up care related to medication. The results indicated that both groups emphasized corresponding aspects of what was important regarding medication. However, when it came to follow-up care, the two groups highlighted distinct aspects, indicating differing priorities or concerns in this area.

"I Think You Covered the Three Levels of Drugs and Consent": Qualitatively Testing Different Operationalizations of an Alcohol and Other Drugs-Involved Sexual Violence.

Substance-involved rape is increasing among college students, particularly women (Koss et al., 2022). Addressing rape requires first measuring it accurately in surveys to understand its true scope and nature. We used cognitive interviews with 40 young adults to qualitatively test the construct validity of an alcohol- and other drugs (AOD)-involved rape item in the Sexual Experiences Survey by asking participants to comment on different operationalizations of this construct. Our findings revealed that different phrasings elicited different interpretations of the items by participants. Specifically, the results indicated that (1) respondents viewed the different operationalizations as a sequence of events with varying severity; (2) some participants focused on the intentionality and responsibility of the perpetrator as opposed to opportunistic perpetration; and (3) study participants consistently chose one of the operationalizations as describing "being roofied" (being drugged without consent). Participants also contributed additional scenarios not described in the questionnaire and shared their interpretations of the items. The results underscore the importance of refining survey language to properly measure AOD-involved rape and allow us to understand how to tailor appropriate questions for best comprehension. The findings indicate the benefit in including several items about AOD-involved rape in questionnaires such as the Sexual Experiences Survey, with each item addressing different scenarios of victim intoxication. The results could also have important implications for sexual violence prevention programs, which should discuss consent, intentions, and responsibility specifically in the context of AOD consumption.

Forward and Back is Not Enough: Applying Best Practices for Translation of Pediatric Sleep Questionnaires.

Cultural differences in the experience of sleep warrant consideration in the measurement of sleep across populations. This requires careful attention to both language and culture when translating survey measures. While forward and back translation is the most commonly used approach, it has numerous limitations if used as an isolated method. Best practice guidelines recommend a multi-step team-based approach for translating questionnaires. We present our recent experience applying best practices in a study with both Spanish and English-speaking Mexican American mothers of toddlers. This work is part of a larger project that will measure parental sleep-related beliefs and parenting practices in Mexican American parents of toddlers. We utilized a team-based approach to translation and cultural adaptation, assembling a diverse, bilingual, and bicultural team. The translation process started with items and measures that we had selected, revised as needed, or created. New items were based on constructs identified in semi-structured interviews and focus groups used to explore parental sleep-related beliefs and parenting practices in the target population. Following this, our translation process included forward and back translation, harmonization and decentering, cognitive interviewing, debriefing, adjudication, and proofreading. We outline details of our process and the rationale for each step. We also highlight how each step contributes to ensuring culturally appropriate items with conceptual equivalence across languages. To ensure inclusivity and scientific rigor within the field of sleep research, investigators must utilize best practices for translations and cultural adaptations, building on the foundation of cultural constructs often identified in qualitative work.

What do you think it means? Using cognitive interviewing to improve measurement in implementation science: description and case example.

Pragmatic measures are essential to evaluate the implementation of evidence-based interventions. Cognitive interviewing, a qualitative method that collects partner feedback throughout measure development, is particularly useful for developing pragmatic implementation measures. Measure developers can use cognitive interviewing to increase a measure's fit within a particular implementation context. However, cognitive interviewing is underused in implementation research, where most measures remain "homegrown" and used for single studies. We provide a rationale for using cognitive interviewing in implementation science studies and illustrate its use through a case example employing cognitive interviewing to inform development of a measurement-based care protocol for implementation in opioid treatment programs. Applications of cognitive interviewing, including developing a common language with partners and collecting multi-level feedback on assessment procedures, to improve measurement in implementation science are discussed.

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.

Interpretation and content validity of the items of the Hamilton inventory to evaluate outcomes in Persian-speaking patients with complex regional pain syndrome: A cognitive interview approach.

BACKGROUND: The Hamilton Inventory for complex regional pain syndrome (CRPS) is a multidisciplinary assessment tool to evaluate signs and symptoms in patients with CRPS, developed in the English language. PURPOSE: This study aims to translate and cross-culturally adapt this tool for Persian-speaking patients with CRPS. Furthermore, this study aimed to understand how 1) Persian-speaking experts and patients interpret and calibrate responses to items on the Hamilton Inventory and 2) compensatory strategies that might affect responses. STUDY DESIGN: A cross sectional study with cognitive interview method. METHODS: Ten health care providers and 10 patients with CRPS were interviewed using cognitive interviewing techniques (talk-aloud, semi-structured interview probes). All interviews were recorded and transcribed verbatim. A directed content analysis was done to analyze the interviews using a previously established framework. RESULTS: Overall, the items on the Hamilton Inventory were well received by participants. Areas, where questions were unclear to some participants were recorded and categorized into five themes: Clarity and Comprehension (100%) in item 1 from the health professional tool and (65%) from the eleven items of the patient-reported tool. Perspective modifiers of culture influenced the calibrations of items "I feel my condition has negatively affected my relationships." (12%) and "My symptoms affect my comfort level with intimacy." (20%) from the patient-reported tool. CONCLUSION: The findings of this study demonstrate that there is no need for substantive changes to the items of the Hamilton Inventory, as they tend to be understood by Persian-speaking experts and patients with CRPS.

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.

The Use of an Iterative Strategy of Cognitive Interview and Expert Consultation to Revise the Quality of Life Scale for Patients with Aplastic Anemia (QLS-AA).

Background: Aplastic anemia is characterized by anemia, hemorrhage and infection, and is accompanied by a variety of complications and psychological burden. Therefore, the quality of life of AA patients is not optimistic. Our team is committed to developing an assessment tool for the quality of life of AA patients, and adopting an iterative strategy of cognitive interview and expert consultation to solve the challenges encountered in item revision. Purpose: We aim to use the strategy of cognitive interview and expert consultation to inform revision of the QLS-AA into a user-friendly tool with unambiguous items and improve the content validity of the scale. Methods: We used an iterative strategy of cognitive interview and expert consultation. Two rounds of cognitive interview were conducted to identify problems with item comprehension, recall and other cognitive processes. As well as, a multi-disciplinary group of expert consultation was consulted to review the rationality of item revisions. Results: In the first round of cognitive interview, 16 participants responded to 107 items. Among them, the most common problems were "clarification" and "item duplication". Based on the results of the first round of interview, an expert consultation was organized. A total of 16 amendments were put forward by the expert and 14 were adopted. In the second round of cognitive interviews, A total of 5 participants were included and 64 items were evaluated. Two items were suggested to be revised, and the remaining items were accurately understood and recognized by all participants. Couclusion: This study highlights the key issues to consider when incorporating patient perspectives into quality measurement. The revision of QLS-AA through the strategy of cognitive interview and expert consultation may provide valuable insights into the measurement of quality of life in aplastic patients. Trial Registration Number: ChiCTR2100047575.

Evidence of the content validity, acceptability, and feasibility of a new Patient-Reported Impact of Dermatological Diseases measure.

Background: The Global Research on the Impact of Dermatological Diseases (GRIDD) team is developing the new Patient-Reported Impact of Dermatological Diseases (PRIDD) measure of the impact of dermatological conditions on the patient's life, in partnership with patients. To develop PRIDD, we conducted a systematic review, followed by a qualitative interview study with 68 patients worldwide and subsequently a global Delphi survey of 1,154 patients to ensure PRIDD items were meaningful and important to patients. Objective: To pilot test PRIDD with patients with dermatological conditions, focusing on its content validity (comprehensiveness, comprehensibility, and relevance), acceptability, and feasibility. Methods: We conducted a theory-led qualitative study using the Three-Step Test-Interview method of cognitive interviewing. Three rounds of semi-structured interviews were conducted online. Adults (≥ 18 years) living with a dermatological condition and who spoke English sufficiently to take part in the interview were recruited through the International Alliance of Dermatology Patient Organizations' (GlobalSkin) global membership network. The topic guide met the gold-standard COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) standards for cognitive interviewing. Analysis followed the thematic analytical model of cognitive interviewing. Results: Twelve people (58% male) representing six dermatological conditions from four countries participated. Overall, patients found PRIDD to be comprehensible, comprehensive, relevant, acceptable, and feasible. Participants were able to discern the conceptual framework domains from the items. Feedback resulted in: the recall period being extended from 1 week to 1 month; removal of the 'not relevant' response option; and changes to the instructions and item ordering and wording to improve clarity and increase respondents' confidence in their ability to respond. These evidence-based adjustments resulted in a 26-item version of PRIDD. Conclusion: This study met the gold-standard COSMIN criteria for the pilot testing of health measurement instruments. The data triangulated our previous findings, in particular the conceptual framework of impact. Our findings illuminate how patients understand and respond to PRIDD and other patient-reported measurement instruments. The results of comprehensibility, comprehensiveness, relevance, acceptability, and feasibility of PRIDD provide evidence of content validity from the target population. The next step in the development and validation of PRIDD is psychometric testing.

Know Pain, No Pain? Preliminary Testing and Application of a New Tool to Assess Biopsychosocial Pain Concepts in Children.

To deliver tailored pain science education, assessing children's biopsychosocial pain concepts is necessary. As validated tools are lacking, a new tool is presented, the biopsychosocial pain concept matrix (BiPS matrix), which assesses children's biological, psychological, and social pain concepts in five domains according to the Common-Sense Model of Self-Regulation (Hagger and Orbell, 2003): (1) illness identity, (2) causes, (3) consequences, (4) duration, and (5) treatment. The present preliminary study aims to (1) assess the items' readability and understandability in cognitive interviews with N = 9 healthy children (9 to 19 years, M = 13.78 years, SD = 3.05; 44% female) and (2) pre-test the BiPS matrix within an online survey of N = 27 healthy children (9 to 19 years, M = 13.76 years, SD = 3.03; 56% female). Results revealed difficulties in understanding some items. Children's understanding increased with age. Age, chronic pain status, and pain in the social environment were positively associated with the BiPS total score, whereas the latter explained the most variance in pain concepts of children. Patient-focused methods such as cognitive interviews proved essential in testing the readability and understanding of items in children. Future studies are warranted to further validate the BiPS matrix.

Development of ELIP to Assess Physical Literacy for Emerging Adults: A Methodological and Epistemological Challenge.

Purpose: Following increased interest in physical literacy (PL), development of appropriate tools for assessment has become an important next step for its operationalization. To forward the development of such tools, the objective of this study was to build the foundations of the Évaluation de la Littératie Physique (ELIP), designed to help reduce existing tensions in approaches to PL assessment that may be resulting in a low uptake into applied settings. Methods: We followed two steps: (1) the development of the first version of ELIP by deploying a Delphi method (n = 30); and (2) the modification of items through cognitive interviews with emerging adults (n = 32). Results: The expert consensus highlighted four dimensions of PL to be assessed-physical; affective; cognitive; and social-with new perspectives, including a preference for broad motor tests over fitness. Conclusion: Results offer new insights into the assessment of emerging adults' PL, but ELIP still requires further work concerning validity, reliability, and sensitivity.

Patient and care partner assessments of diagnostic excellence in the emergency department: A cognitive interview study.

Background: Diagnostic excellence encompasses both receiving an accurate and timely explanation of a health problem that was communicated well, and the process it took to get to the correct diagnosis. Directly eliciting patients' perceptions of their diagnostic experience and outcomes after emergency visits is a promising method of assessing diagnostic excellence. However, little is known about how patients interpret and respond to questions about their diagnostic experiences and outcomes. Objective: To analyze patient and care partners' interpretation of questions capturing patient-reported diagnostic excellence in emergency settings. Design: Cognitive interviews using think-aloud and probing methods. Settings: Interviews were conducted virtually and via phone calls. Participants were patients or care partners of patients recently discharged from three emergency departments within a single academic health system in the Mid-Atlantic region of the US. Participants: 15 patients and care partners, 18 years or older, with recent emergency department experiences. Methods: Qualitative analysis using a deductive approach was used to code transcripts and analyze participant responses to Patient-Report to Improve Diagnostic Excellence in Emergency Department (PRIME-ED) questionnaire items. Themes of patient and care partners' questionnaire interpretations are presented descriptively. Results: 80% of participants were female, 47% were between the ages of 18-24 years, 47% of participants were White, and 7% were Hispanic/Latino. Participants shared their interpretations of diagnostic excellence following PRIME-ED domains: diagnostic accuracy and care team skills, their comprehension of the diagnosis, provider communication of uncertainty, and quality of diagnostic communication, including whether they felt the care team communicated well, adapted communication to their needs, listened and took concerns seriously, treated them as an equal, and provided clear, sufficient, and functional communication about follow-up steps. Responses indicated that patients and care partners can identify diagnostic errors, rationalize why their diagnosis was inaccurate, and assess whether diagnostic excellence was achieved. Respondents identified factors that contributed to their assessments of diagnostic accuracy and the quality of diagnostic communication. The quality of diagnostic communication contributed to patient perception of diagnostic accuracy and understanding of the diagnosis. Conclusions: Patient report is a useful tool for assessing diagnostic excellence in emergency settings. Our patient and care partners describe how they assess diagnostic excellence in the emergency department.Registration: N/A.Tweetable abstract: Patients and care partners provide accessible and useful information to assess diagnostic practices and diagnostic excellence in emergency departments.

Use of a focus group-based cognitive interview methodology to validate a cooking behavior survey among African-American adults.

Disparities in diet-related diseases persist among African-Americans despite advances in risk factor identification and evidence-based management strategies. Cooking is a dietary behavior linked to improved dietary quality and cardiometabolic health outcomes. However, epidemiologic studies suggest that African-American adults report a lower frequency of cooking at home when compared to other racial groups, despite reporting on average cooking time. To better understand cooking behavior among African-Americans and reported disparities in behavior, we sought to develop a survey instrument using focus group-based cognitive interviews, a pretesting method that provides insights into a survey respondent's interpretation and mental processing of survey questions. A comprised survey instrument was developed based on input from a community advisory board, a literature review, and a content review by cooking behavior experts. The cognitive interview pretesting of the instrument involved African-American adults (n = 11) at risk for cardiovascular disease who were recruited from a community-based participatory research study in Washington, D.C., to participate in a focus group-based cognitive interview. Cognitive interview methodologies included the verbal think-aloud protocol and the use of retrospective probes. Thematic analysis and evaluation of verbalized cognitive processes were conducted using verbatim transcripts. Five thematic themes related to the survey were generated: (1) Clarity and relevancy of question items; (2) influence of participants' perspectives and gender roles; (3) participant social desirability response to questions; (4) concern regarding question intent. Eleven survey items were determined as difficult by participants. Cooking topics for these items were: cooking practices, cooking skills, cooking perception (how one defines cooking), food shopping skills, and socialization around cooking. Question comprehension and interpreting response selections were the most common problems identified. Cognitive interviews are useful for cooking research as they can evaluate survey questions to determine if the meaning of the question as intended by the researcher is communicated to the respondents-specific implications from the results that apply to cooking research include revising questions on cooking practice and skills. Focus-group-based cognitive interviews may provide a feasible method to develop culturally grounded survey instruments to help understand disparities in behavior for culturally relevant diet behaviors such as cooking.

Validating a Self-Reported Medication Nonadherence Measure in the Context of Multiple Chronic Diseases and Routes of Medication Administration Among Patients with Type 2 Diabetes.

Introduction: Patients with diabetes may take oral and injectable medications and often have comorbid chronic diseases. It is unclear whether to assess nonadherence for oral and injectable medications separately or combined and for comorbid conditions separately or combined. Research Design and Methods: We conducted two cognitive interview studies among patients with type 2 diabetes who were prescribed medications for oral or injectable diabetes medications (Study 1) or at least one diabetes, blood pressure, and cholesterol medication (Study 2). Participants completed the two-domain DOSE-Nonadherence measure, which assesses extent of nonadherence and reasons for nonadherence. We asked about interpretation of instructions and items, recall period, ability to respond accurately with separate versus combined versions, and comprehensiveness of reasons for nonadherence to injectable medications. Results: Based on Study 1 (n=14), nonadherence to injectable and oral medications should be assessed separately. Participants believe they can respond accurately to 7-day recall period for daily medications and a one-month recall period for weekly injectable medications. New reasons for nonadherence to injectable medications were perceived as relevant. Based on Study 2 (n-12), nonadherence to medications for diabetes, blood pressure, and cholesterol should be assessed separately. Conclusion: Although separate versions increase response time, it may improve accuracy. Responses to the measure can facilitate conversations about nonadherence between providers and patients to inform clinical decision-making.

Exploring the validity of the body image scale with survivors of breast cancer: A cognitive interview approach.

OBJECTIVE: The aim of this study is to explore the construct validity of the Body Image Scale for Cancer Questionnaire (BIS) using cognitive interviews. METHODS: Twelve breast cancer survivors participated in a cognitive interview while completing the BIS. Each participant was asked to think-out-loud while answering items, and an interviewer asked probing questions relating to the participants' comprehension, example retrieval, certainty of answer and other decision-making factors. Interviews were audio recorded and transcribed, and the data were analysed deductively and inductively. RESULTS: The participants' interpretations of the questions varied significantly. Several participants perceived the phrasing of some questions to be leading. The participants were able to provide examples of how their physical, physiological and body function affected their body image. The participants expressed positive attitudes towards, and gratitude for their body, which was not captured by the questionnaire. At times, the participants felt uncertain in how to respond appropriately to specific items, and the participants found some items challenging to answer. Finally, the BIS included sensitive questions that elicited emotional reactions and discomfort for some participants. CONCLUSION: The findings of this study provide insight into, and suggestions for potential questionnaire revisions that may enhance the validity and relevance of the BIS for use with breast cancer survivors.

"How Are My Age and Cows Related?" Cognitive Interviewing as a Tool to Pretest Survey Questions in Two Limited Resource Settings.

Antimicrobial resistance is a complex topic requiring interdisciplinary solutions embedded in One Health thinking. Currently, many surveys are underway in low- and middle-income countries to study how antimicrobial use in the livestock sector is driving resistance. In a survey, the respondents must understand and answer the questions correctly to produce accurate and valuable results. Pretesting survey questions is therefore important but sometimes not performed due to limited time and resources. Cognitive interviewing is a pretesting method to give insights into the respondent's way of interpreting and mentally processing the survey questions to identify problems and finding ways to improve the questions. It has previously been suggested that cognitive interviews may be difficult to use in some cultural settings. This study aimed to use cognitive interviews in a respondent-adjusted way to study how survey questions related to antimicrobial use are understood and answered by 12 small-scale farmers in Kenya and Uganda. The results show that even a small number of interviews and using interviewers with limited knowledge of cognitive interviewing can identify many problems in survey questions and the survey tool. Cognitive interviews may provide a feasible and affordable way of pretesting questionnaires in situations where time and resources are limited, for example, during a disease outbreak.

A Qualitative Investigation of Older Adults' Conceptualization of Quality of Life and a Think-Aloud Content Validation of the EQ-5D-5L, SF-12v2, Warwick Edinburgh Mental Wellbeing Scale, and Office of National Statistics-4.

OBJECTIVES: Old age is characterized by declining health, comorbidities, and increasing health and social care service use. Traditionally, patient-reported outcome measures (PROMs) including the EQ-5D-5L and SF-12v2 have focused on health. Nevertheless, aged care often aims to improve broader elements of quality of life (QoL), captured by well-being measures, such as the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) and Office of National Statistics-4 (ONS-4). This study investigates older adults' conceptualization of QoL and the content validity of the EQ-5D-5L, SF-12v2, WEMWBS, and ONS-4 in measuring their QoL. METHODS: Qualitative cognitive think-aloud interviews were undertaken with older adults aged 75+, exploring their views on what was important to QoL and, for each measure, the relevance, acceptability, and interpretation of items; suitability of response options; and the comprehensiveness of the measure. Conceptualization of QoL was analyzed thematically and content validity using framework analysis. RESULTS: Twenty interviews were undertaken. Older adults' conceptualization of QoL centered on health, ability to perform usual activities, social contact, and emotional functioning. Possible response shift was observed, as older adults assessed their health relative to lower health expectations at their age or to people in worse states. Participants questioned the relevance of negatively phrased mental items and often preferred the functioning-focused EQ-5D-5L to more subjective ONS-4 and WEMWBS items. Domains suggested to improve comprehensiveness included social contact, coping, security, dignity, and control. CONCLUSIONS: These findings are useful to researchers developing new PROMs for older adults or for the developers of included PROMs considering permanently adapting or bolting-on domains to improve content validity in older adults.

Content validation of a caregiver diary to monitor severity and recovery of pediatric patients with respiratory syncytial virus infection.

BACKGROUND: Respiratory Syncytial Virus (RSV) is a leading cause of hospitalization and serious respiratory illness in infants/young children. The objectives of this study were to (1) identify important RSV-related signs of illness in infants that were observed by the parent/caregiver of the child and (2) assess content validity and usability of the Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) to monitor signs of RSV-related illness. METHODS: Review of medical literature identified signs of pediatric RSV-related illness in PRESORS. Semi-structured interviews with caregivers of infants (0-24 months of age) hospitalized with laboratory-confirmed RSV infection (in the two months prior to recruitment) were conducted to spontaneously elicit signs and impacts of the infant's illness from caregiver observations. Caregivers completed PRESORS using a "think-aloud" protocol to confirm comprehension, relevance, and usability of the smartphone application. Verbatim transcripts were analyzed using thematic analysis methods and Atlas.ti software. RESULTS: Interviews with 21 caregivers confirmed PRESORS captured 23/26 signs caregivers spontaneously reported. Cough, difficulty breathing, problems sleeping, and reduced feeding/drinking were the most worrying signs of severe RSV-related illness described. Cognitive debriefing indicated that caregivers: understood the wording of all PRESORS items and response options (except how to count heartbeats), recall periods were appropriate, and the PRESORS smartphone application was easy to use. Minor changes to enhance content validity were identified. CONCLUSIONS: In-depth interviews confirmed content validity and usability of the PRESORS by caregivers of infants with RSV. Next steps are to assess the revised PRESORS in clinical studies and evaluate its measurement properties.

Extension and Evaluation of the PROMIS Sexual Function and Satisfaction Measures for Use in Adults Living With Multiple Sclerosis.

BACKGROUND: Sexual dysfunction is a common symptom of multiple sclerosis (MS). Clinically meaningful and psychometrically sound measures of sexual function validated in people with MS are necessary to identify people with MS who experience problems with sexual function. AIM: To evaluate the Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction (SexFS) v2.0 measure in people with MS and to extend the PROMIS SexFS Brief and Full Profiles to include additional aspects of sexual function relevant to people living with MS. METHODS: A convenience sample of MS clinicians and sexually active individuals with MS ranked relevance of 26 items that listed specific factors that interfere with sexual function. Rankings were used to select items to include in the modified SexFS for Multiple Sclerosis (SexFS-MS) profiles. Sex-FS Brief and Full profiles along with the top 22 ranked interfering factor items underwent cognitive interviews (CI) to assess whether the items were understandable and meaningful. OUTCOMES: The SexFS as originally published functioned well in people with MS after minor modifications. RESULTS: Twelve MS clinicians and 26 people with MS ranked items. The 10 highest ranked questions about factors that interfere with sexual function most relevant to people with MS were added to the SexFS-MS Brief profiles and 18 to the Full profiles. Ten men and 12 women with MS participated in CIs and found most items to be clear and meaningful. However, important changes were made to the profile instructions, some response sets, and to some items to improve clarity and function. New items to assess numbness and reasons why sexually active people choose at times not to engage in sexual activity were added. CLINICAL IMPLICATIONS: Brief and Full profiles are freely available and are recommended for research and clinical practice that include people with MS. STRENGTHS & LIMITATIONS: This study is the first to provide validity evidence for the PROMIS SexFS in people living with MS. Though the PROMIS SexFS was tested in people who identify as lesbian, gay, or bisexual, only individuals who identified as heterosexual participated in this study. Results may not represent views of people with MS who identify as other sexual orientations who may have different concerns and priorities related to sexual function. CONCLUSION: This study extended the PROMIS SexFS Brief and Full profiles to create the SexFS-MS by adding items that measure most relevant issues related to sexual function in individuals living with MS. Amtmann D, Bamer AM, Salem R, et al. Extension and Evaluation of the PROMIS Sexual Function and Satisfaction Measures for Use in Adults Living With Multiple Sclerosis. J Sex Med 2022;19:719-728.