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.

"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.

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.

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.

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.

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.

Psychometric properties of the end-of-life care decision inventory (EOL-CDI): a mixed-methods study.

BACKGROUND: End-of-life care decision-making has become important to support dignity and quality of life for patients who are facing death in Korea, along with the enactment of the Life-Sustaining Treatment Act in 2018. However, it seems that the concepts and policies related to the law are not yet familiar to health care providers or the general public. This unfamiliarity can hinder efficient end-of-life care discussions. Therefore, the purpose of this study was to propose a valid and reliable tool to explore the level of understanding of concepts and attributes related to end-of-life care decisions. METHODS: This is a mixed-methods study design. A relevant law and literature analysis, expert consultation, cognitive interviews of 10 adults, and cross-sectional survey for psychometric tests using data from 238 clinical nurses were performed to update a tool developed before the life-sustaining treatment Act was enacted in Korea. RESULTS: 29 items of the draft version were polished in terms of literacy, total length, and scoring method via cognitive interviews and finalized into 21 items through psychometric tests and expert consultations. The 21 items conformed to the Rasch unidimensional paramenters. CONCLUSION: A tool to identify the level of understanding of concepts related to end-of-life care decisions was proposed through a rather rigorous process to ensure feasibility and validity/reliability. We recommend the proposed tool to apply to the adult population and nurses for evaluation and educational purposes.

Development of a patient-reported outcome measure for the assessment of symptom burden in pediatric chronic kidney disease (PRO-Kid).

BACKGROUND: Chronic kidney disease (CKD) and kidney failure in childhood are associated with significant and life-altering morbidities and lower quality of life. Emerging evidence suggests that management should be guided in part by symptom burden; however, there is currently no standardized assessment tool for quantifying symptom burden in this pediatric population. This study aimed to develop and refine a patient-reported symptom assessment tool for children with CKD/kidney failure (PRO-Kid), to evaluate the frequency and impact of symptoms. METHODS: This was a prospective observational study of children and caregivers of children with CKD/kidney failure at two Canadian pediatric care centers. Building on previously published patient-reported outcome measures (PROs) for the assessment of symptom burden in other populations, we drafted a 13-item questionnaire. Cognitive interviews were performed with children and caregivers of children with CKD/kidney failure to iteratively refine the questionnaire. RESULTS: Twenty-four participants completed cognitive interviewing (11 children, 13 caregivers). The most common symptoms endorsed were feeling left out, feeling sad/depressed, inability to focus, tiredness, nausea, vomiting, not wanting to eat, and changes in the taste of food. Feeling left out was added to the questionnaire as almost all participants voiced this as a frequent and impactful symptom, resulting in a 14-item questionnaire. CONCLUSIONS: PRO-Kid is the first pediatric CKD/kidney failure-specific PRO tool to assess symptom burden. Future work should validate this tool in a larger cohort so that it may be used to improve the care of children living with CKD/kidney failure. A higher resolution version of the Graphical abstract is available as Supplementary information.

The use of composite time trade-off and discrete choice experiment methods for the valuation of the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS): a think-aloud study.

PURPOSE: To identify patterns and problems in completing composite time trade-off (C-TTO) and discrete choice experiment (DCE) exercises for the valuation of the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) to inform the optimisation of a valuation protocol. METHODS: Fourteen cognitive interviews were conducted in the UK using concurrent and retrospective think-aloud and probing techniques. Each participant completed 8 C-TTO tasks and 8 DCE tasks within a computer-assisted personal interview setting. Verbal information was transcribed verbatim. Axial coding and thematic analysis were used to organise the qualitative data and identify patterns and problems with the completion of tasks. RESULTS: While participants found the tasks generally manageable, five broad themes emerged to explain and optimise the response to the tasks. (1) Format and structure: attention to the design of practice examples, instructions, and layout were needed. (2) Items and levels: underlying relationships were discovered across different combinations of levels of SWEMWBS items. (3) Decision heuristics: participants engaged in diverse strategies to assist trade-off decisions. (4) Valuation feasibility: certain states were difficult to imagine, compare and quantify. (5) Valuation outcome: the data quality was affected by participants' discriminatory ability across states and their time trade-off decisions. CONCLUSION: The interviews contributed insights regarding the robustness of the proposed methods. The application of C-TTO and DCE valuation techniques was practical and suitable for capturing individual attitudes towards different mental well-being scenarios. A modified protocol informed by the results is being tested in a larger sample across the UK.

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.

Translation and cultural adaptation of the Family Centered Care Assessment Scale (FCCAS) for Finnish pediatric nursing.

PURPOSE: The purpose of this study was to translate and culturally adapt the Family Centered Care Assessment Scale (FCCAS) to evaluate family-centered care in the context of Finnish pediatric nursing. DESIGN AND METHODS: The translation and cultural adaptation were done according guidelines of International Society for Pharmacoeconomics and Outcomes (ISPOR), which constitute a systematic process including ten phases. The presented research included cognitive interviews conducted with the end user of the scale: parents of hospitalized children. RESULTS: The FCCAS was successfully translated and culturally adapted to the Finnish context. Translational, clinical and parental expertise were used to develop the scale. Conceptual equivalence was achieved in the translation. In the cultural adaptation, some of the items were modified based on experts' assessments to make them comprehensible and appropriate to the Finnish culture. The scale showed good evidence of content. Reporting of the study adheres to the COSMIN checklist. CONCLUSIONS: Combining ISPOR guidelines and cognitive interviews are recommended to use in the translation and cultural adaptation process. Nursing staff and parents' involvement and awareness of family-centered care have been concretized. Systematic translation and cultural adaptation have prepared a Finnish version of the scale for psychometric testing. PRACTICE IMPLICATIONS: The study outlines how rigorous methodological approaches can be applied to the translation and cultural adaptation of a measurement tool. The developed scale includes items which comprehensively cover family-centered care characteristics. In following study, it will be possible to evaluate the extent to which family-centered care is implemented in Finnish pediatric nursing.

A Contribution to Measure Partnership Trust in Community-Based Participatory Research and Interventions With Latinx Communities in the United States.

Given the growing diversity in the United States, responsiveness to the needs of diverse communities is paramount. Latinx communities in the United States often state mistrust in outside institutions because of adverse experiences. Community-based participatory research (CBPR) is considered a trust-building process and is one approach to understand disparities. However, the conceptualization and evaluation of trust as a CBPR outcome are understudied. This article summarizes a community-engaged research process conducted for the cultural and linguistic refinement of a partnership trust survey tool to assess partnership trust as an outcome of CBPR (CBPR-PTS), by using Perinatal Awareness for Successful Outcomes (PASOs) as a case study and cross-cultural cognitive interviewing (CCCI) methodology. The participants were 21 diverse stakeholders of PASOs, a community-based health organization that serves the Latinx population in South Carolina. A modified version of the multidimensional measure of trust model informed instrument development. The team analyzed the CCCI data using compiling informal analysis to identify which survey items' wordings must be changed or adapted based on the participants' accounts. Sixteen of 28 questions subjected to CCCI required modifications due to translation errors, culturally specific errors, or general cognitive problems. The new survey instrument has 19 scales and 195 items categorized into nine dimensions of the modified multidimensional measure of trust model. CCCI was a useful tool to address the cross-cultural understanding issues of the CBPR-PTS. Measurement instruments should be able to capture the socioeconomic, cultural, and geographic/environmental variability of community stakeholders to help understand the diversity of the comprehension and views of the communities involved in disparities' reduction efforts.

Using cognitive interviewing to bridge the intent-interpretation gap for nutrition coverage survey questions in India.

Designing survey questions that clearly and precisely communicate the question's intent and elicit responses based on the intended interpretation is critical but often undervalued. We used cognitive interviewing to qualitatively assess respondents' interpretation of and responses to questions pertaining to maternal and child nutrition intervention coverage. We conducted interviews to cognitively test 25 survey questions with mothers (N = 21) with children less than 1 year in Madhya Pradesh, India. Each question was followed by probes to capture information on four cognitive stages-comprehension, retrieval, judgement, and response. Data were analysed for common and unique patterns across the survey questions. We identified four types of cognitive challenges: (1) retention of multiple concepts in long questions: difficulty in comprehending and retaining questions with three or more key concepts; (2) temporal confusion: difficulty in conceptualizing recall periods such as "in the last 6 months" as compared to life stages such as pregnancy; (3) interpretation of concepts: mismatch of information being asked, meaning of certain terms and intervention scope; and (4) understanding of technical terms: difficulty in understanding commonly used technical words such as "breastfeeding" and "antenatal care" and requiring use of simple alternative language. Findings from this study will be useful for stakeholders involved in survey design and implementation, especially those conducting large-scale household surveys to measure coverage of essential nutrition interventions.

Perspectives on Conservative Care in Advanced Kidney Disease: A Qualitative Study of US Patients and Family Members.

RATIONALE & OBJECTIVE: Little is known about perceptions of conservative care among patients with advanced kidney disease in the United States. STUDY DESIGN: Qualitative study using cognitive interviewing about attitudes regarding conservative care using decision aids on treatments for advanced kidney disease developed outside the United States. SETTING & PARTICIPANTS: 14 patients 75 years or older with advanced kidney disease, defined as estimated glomerular filtration rate≤20mL/min/1.73m2 and not receiving maintenance dialysis, and 6 of their family members. ANALYTICAL APPROACH: Thematic analysis of participants' reactions to descriptions of conservative care taken from various clinical care decision aids. RESULTS: Participants were mostly White (n=15) and had at least some college education (n=16). Four themes emerged from analysis of interviews: (1) core elements of conservative care: aspects of conservative care that were appealing to participants included a whole-person, team-based, and structured approach to care that focused on symptom management, maintaining current lifestyle, and managing health setbacks; (2) importance of how conservative care is framed: participants were more receptive to conservative care when this was framed as an active rather than passive treatment approach and were receptive to statements of uncertainty about future course of illness and prognosis; (3) an explicit approach to shared decision making: participants believed decisions about conservative care and dialysis should address considerations about risk and benefits of treatment options, family and clinician perspectives, and patients' goals, values, and preferences; and (4) relationship between conservative care and dialysis: although conservative care models outside the United States are generally intended to serve as an alternative to dialysis, participants' comments implied that they did not see conservative care and dialysis as mutually exclusive. LIMITATIONS: Themes identified may not generalize to the broader population of US patients with advanced kidney disease and their family members. CONCLUSIONS: Participants were favorably disposed to a whole-person multidisciplinary approach to conservative care, especially when framed as an active treatment approach. Models of conservative care excluding the possibility of dialysis were less embraced, suggesting that current models will require adaptation to meet the needs of US patients and their families.

Qualitative evaluation of the Autism Behavior Inventory: use of cognitive interviewing to establish validity of a caregiver report scale for autism spectrum disorder.

PURPOSE: The Autism Behavior Inventory (ABI) is an observer-reported outcome scale measuring core and associated features of autism spectrum disorder (ASD). Extensive scale development (reported elsewhere) took place, in alignment with the Food and Drug Administration's patient-reported outcome guidance, to address the need for instruments to measure change and severity of ASD symptoms. METHODS: Cognitive interviewing was used to confirm understanding and content validity of the scale prior to its use in clinical trials. Respondents were caregivers of individuals with ASD (N = 50). Interviews used a hybrid of the "think-aloud" and verbal probing approach to assess ABI's content validity and participant understanding of the instrument, including: item clarity and relevance; item interpretation; appropriateness of response scales; and clarity of instructions. Audio-recordings of the interviews were transcribed for qualitative data analysis. The scale was revised based on participant feedback and tested in a second round of interviews (round 1 N = 38, round 2 N = 12). RESULTS: In total, 67/70 items reached ≥ 90% understandability across participants. Caregivers were able to select an appropriate response from the options available and reported finding the examples helpful. Based on participant feedback, instructions were simplified, 8 items were removed, and 10 items were reworded. The final revised 62-item scale was presented in round 2, where caregivers reported readily understanding the instructions, response options, and 61/62 items reached ≥ 90% understandability. CONCLUSIONS: Cognitive interviews with caregivers of a diverse sample of individuals with ASD confirm the content validity and relevance of the ABI to assess core and associated symptoms of ASD.

How to translate and locally adapt a PROM. Assessment of cross-cultural differential item functioning.

Translating patient-reported outcome measures (PROMs) can alter the meaning of items and undermine the PROM's psychometric properties (quantified as cross-cultural differential item functioning [DIF]). The aim of this paper was to present the theoretical background for PROM translation, adaptation, and cross-cultural validation, and assess how PROMs used in sports medicine research have been translated and adapted. We also assessed DIF for the Knee Injury and Osteoarthritis Outcome Score (KOOS) across Danish, Norwegian, and Swedish versions. We conducted a search in PubMed and Scopus to identify the method of translation, adaptation, and validation of PROMs relevant to musculoskeletal research. Additionally, 150 preoperative KOOS questionnaires were obtained from the Scandinavian knee ligament reconstruction registries, and cross-cultural DIF was evaluated using confirmatory factor analysis and Rasch analysis. There were 392 studies identified, describing the translation of 61 PROMs. Ninety-four percent were performed with forward-backward technique. Forty-nine percent used cognitive interviews to ensure appropriate wording, understandability, and adaptation to the target culture. Only two percent were validated according to modern test theory. No study assessed cross-cultural DIF. One KOOS subscale showed no cross-cultural DIF, two had DIF with respect to some (but not all) items, and thus conversion tables could be constructed, and two KOOS subscales could not be pooled. Most PROM translations are of undocumented quality, despite the common conclusion that they are valid and reliable. Scores from three of five KOOS subscales can be pooled across the Danish, Norwegian, and Swedish versions, but two of these must be adjusted for DIF.

Development of a brief, generic, modular resource-use measure (ModRUM): cognitive interviews with patients.

BACKGROUND: Self-report resource-use measures (RUMs) are often used to collect healthcare use data from participants in healthcare studies. However, RUMs are typically adapted from existing measures on a study-by-study basis, resulting in a lack of standardisation which limits comparability across studies. Psychometric testing of RUMs is rarely conducted. This paper reports on cognitive interviews with patients to test the content validity and acceptability of a new RUM (ModRUM). ModRUM is a brief, generic RUM with a core module on healthcare use and questions/modules to increase depth and breadth. METHODS: A purposeful sampling strategy with maximum variation was used to recruit patients from primary care to participate in "think-aloud" interviews with retrospective probing. Participants verbalised their thought processes as they completed ModRUM, which allowed errors (issues with completion) to be identified. The interviewer asked follow-up and probing questions to investigate errors, clarity and acceptability. Interviews were audio-recorded and transcribed verbatim. Research team members independently scored transcripts to identify errors in comprehension, recall, judgement and response. Members met to agree on final scores. Interview transcripts were analysed qualitatively using techniques of constant comparison, to identify common themes and ideas for improvement. Data collection and analysis were performed concurrently and in rounds. RESULTS: Twenty participants were interviewed between December 2019 and March 2020. Interviews were conducted in three rounds, with revisions made iteratively and in response to interview findings. Seven participants completed the core module and 13 completed the core module plus depth questions. Of 71 issues, 28 were in comprehension, 14 in retrieval, 10 in judgement, 18 in response and 1 uncategorised. Most issues (21 issues by 2 participants) were due to participants including family healthcare use. Other issues included using incorrect recall periods (5 issues) and overlooking questions leading to missing responses (9 issues). Common participant suggestions included highlighting important details and providing additional definition or examples for some terms. The length, content and layout were acceptable to most participants. CONCLUSIONS: A generic RUM is needed to increase study comparability. RUM development requires thorough testing to demonstrate and enhance validity. Cognitive interviewing has demonstrated the acceptability and content validity of ModRUM.

Testing the Digital Health Literacy Instrument for Adolescents: Cognitive Interviews.

BACKGROUND: Despite the increasing number of youth seeking health information on the internet, few studies have been conducted to measure digital health literacy in this population. The digital health literacy instrument (DHLI) is defined as a scale that measures the ability to operate digital devices and read and write in web-based modes, and it assesses seven subconstructs: operational skills, navigation skills, information searching, evaluating reliability, determining relevance, adding self-generated content to a web-based app, and protecting privacy. Currently, there is no validation process of this instrument among adolescents. OBJECTIVE: This study aims to explore the usability and content validity of DHLI. METHODS: Upon the approval of institutional review board protocol, cognitive interviews were conducted. A total of 34 adolescents aged 10-18 years (n=17, 50% female) participated in individual cognitive interviews. Two rounds of concurrent cognitive interviews were conducted to assess the content validity of DHLI using the thinking aloud method and probing questions. RESULTS: Clarity related to unclear wording, undefined technical terms, vague terms, and difficult vocabularies was a major issue identified. Problems related to potentially inappropriate assumptions were also identified. In addition, concerns related to recall bias and socially sensitive phenomena were raised. No issues regarding response options or instrument instructions were noted. CONCLUSIONS: The initial round of interviews provided a potential resolution to the problems identified with comprehension and communication, whereas the second round prompted improvement in content validity. Dual rounds of cognitive interviews provided substantial insights into survey interpretation when introduced to US adolescents. This study examined the validity of the DHLI and suggests revision points for assessing adolescent digital health literacy.

Guidelines for Conducting Virtual Cognitive Interviews During a Pandemic.

The COVID-19 pandemic has challenged researchers working in physical contact with research participants. Cognitive interviews examine whether study components (most often questionnaire items) are worded or structured in a manner that allows study participants to interpret the items in a way intended by the researcher. We developed guidelines to conduct cognitive interviews virtually to accommodate interviewees who have limited access to the internet. The guidelines describe the essential communication and safety equipment requirements and outline a procedure for collecting responses while maintaining the safety of the participants and researchers. Furthermore, the guidelines provide suggestions regarding training of participants to use the technology, encouraging them to respond aloud (a potential challenge given that the researcher is not physically present with the participant), and testing and deploying the equipment prior to the interview. Finally, the guidelines emphasize the need to adapt the interview to the circumstances and anticipate potential problems that might arise.

Development of a measure for patients preparing to start dialysis and their partners: The Starting Dialysis Questionnaire (SDQ).

BACKGROUND: The transition onto dialysis is a stressful time that affects both patients and their partners. Research suggests that psychological and interpersonal characteristics within the couple are related to how well they adapt to dialysis. The aim of this multi-phase, mixed methods study was to develop a measure, the Starting Dialysis Questionnaire (SDQ), that is applicable to both patients and their partners and assesses their own thoughts and feelings about these constructs. METHODS: Data from semi-structured interviews with patients and their partners (n = 22 couples) were analysed using theoretical thematic analysis to identify and define constructs related to quality of life (QOL). Next, items addressing these constructs were derived from the interviews. Then, cognitive interviews were conducted with patients with chronic kidney disease and their partners (n = 5 couples) to assess the face validity and comprehensibility of the items. Lastly, preliminary psychometric properties were evaluated in a sample of patients preparing to start dialysis and their partners (n = 83 couples). RESULTS: Three themes related to QOL were identified, namely dialysis expectations, accepting dialysis and dyadic relationship characteristics. The cognitive interviews refined the SDQ and established its face validity. Psychometric assessments indicated that overall the items performed well and did not show significant floor or ceiling effects. Good internal consistency was found within the three domains, and items correlated within the domains. CONCLUSIONS: The SDQ is a measure (34 items) that assesses key psychological and interpersonal factors in patients and their partners as they start dialysis. It shows good preliminary psychometric properties; however, a large-scale field trial is needed to establish its validity. Once validated, it could offer a clinically useful tool to assist clinicians in preparing patients and partners for dialysis.