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Cognitive interviewing in the form of probing is key for developing methodologically sound survey questions. For a long time, probing was tied to the laboratory setting, making it difficult to achieve large sample sizes and creating a time-intensive undertaking for both researchers and participants. Web surveys paved the way for administering probing questions over the Internet in a time- and cost-efficient manner. In so-called web probing studies, respondents first answer a question and then they receive one or more open-ended questions about their response process, with requests for written answers. However, participants frequently provide very short or no answers at all to open-ended questions, in part because answering questions in writing is tedious. This is especially the case when the web survey is completed via a smartphone with a virtual on-screen keypad that shrinks the viewing space. In this study, we examine whether the problem of short and uninterpretable answers in web probing studies can be mitigated by asking respondents to complete the web survey on a smartphone and to record their answers via the built-in microphone. We conducted an experiment in a smartphone survey (N  =   1,001), randomizing respondents to different communication modes (written or oral) for answering two comprehension probes about two questions on national identity and citizenship. The results indicate that probes with requests for oral answers produce four to five times more nonresponse than their written counterparts. However, oral answers contain about three times as many words, include about 0.3 more themes (first probing question only), and the proportion of clearly interpretable answers is about 6 percentage points higher (for the first probing question only). Nonetheless, both communication modes result in similar themes mentioned by respondents. [ABSTRACT FROM AUTHOR]

We describe the prevalence and nature of cognitive interviewing (CI) for testing survey questionnaires in the United States and compare our results to those from Blair and Presser's similar study of three decades ago when such testing was relatively new. We find that although CI is now much more common than in 1993, there are still many organizations that do not use it. In addition, we find that there has been only a modest reduction in the great variation of ways CI is conducted both within and across organizations. We interpret this variability mainly as a reflection of the lack of consensus about best practices and call for research that will make consensus about best practices more likely. [ABSTRACT FROM AUTHOR]

To design user-centered services, it is essential to build empathy toward users. It is hence strategic to trigger empathy for users among professionals concerned with shaping service user experiences. There is, however, a lack of quantitative tools to measure empathy in design. Through two studies, we report on the development and validation of the Empathy in Design Scale (EMPA-D). The tool aims to measure service employees' empathy toward users. Grounded in theories from psychology and design, we first generated and tested a pool of items through expert inspection and cognitive interviews. In Study 1, we administered 16 items to 406 full-time service employees from various industries, including employees in customer-facing positions. In Study 2, we iterated on additional items and administered a revised scale to 305 service employees. The selected model consists of 11 items and has a three-factor structure (Emotional interest/Perspective-taking , Personal experience and Self-awareness) , which showed an adequate model fit and good internal consistency. Evidence of convergent validity was provided by moderate correlations of the EMPA-D scale with empathy measures in psychology (SITES, Empathy Quotient, Interpersonal Reactivity Index), whereas discriminant validity was demonstrated by low correlations with the narcissism measure Narcissistic Personal Inventory. We outline how this self-reported empathy measure can support organizations in enhancing their services and discuss potential limitations of quantitatively measuring empathy in service teams. Research Highlights We present the development and validation of the Empathy in Design Scale (EMPA-D), a self-report measure of employees' empathy toward users of a service. We report on two validation studies and document the psychometric properties of the scale. The selected model consists of 11 items and a three-factor structure (Emotional interest/Perspective-taking, Personal experience and Self-awareness). The resulting EMPA-D scale contributes to filling the gap in metrics to assess empathy in the service design context. In industry, measuring employees' empathy support the selection of appropriate empathic interventions to foster the service user-centeredness. [ABSTRACT FROM AUTHOR]

Background Serious injection-related infections (SIRIs) in people who inject drugs often lead to prolonged hospitalizations or premature discharges. This may be in part due to provider reluctance to place peripherally inserted central catheters (PICCs) for outpatient parenteral antibiotic therapy in this population. Because internal medicine (IM) residents are often frontline providers in academic centers, understanding their perspectives on SIRI care is important to improve outcomes. Methods We surveyed IM residents in a large urban multicenter hospital system about SIRI care with a novel case-based survey that elicited preferences, comfort, experience, and stigma. The survey was developed using expert review, cognitive interviewing, and pilot testing. Results are reported with descriptive statistics and linear regression. Results Of 116 respondents (response rate 34%), most (73%) were uncomfortable discharging a patient with active substance use home with a PICC, but comfortable (87%) with discharge to postacute facilities. Many (∼40%) endorsed high levels of concern for PICC misuse or secondary line infections, but larger numbers cited concerns about home environment (50%) or loss to follow-up (68%). While overall rates were low, higher stigma was associated with more concerns around PICC use (r = −0.3, P =.002). A majority (58%) believed hospital policies against PICC use in SIRI may act as a barrier to discharge, and 74% felt initiation of medications for opioid use disorder (MOUD) would increase their comfort discharging with a PICC. Conclusions Most IM residents endorsed high levels of concern about PICC use for SIRI, related to patient outcomes and perceived institutional barriers, but identified MOUD as a mitigating factor. [ABSTRACT FROM AUTHOR]

Background Advance care planning (ACP) aims to ensure that people with chronic or advanced disease receive medical care that is consistent with their values and preferences. However, professionals may find it challenging to engage these patients in conversations about the end of life. We sought to develop a pictorial tool to facilitate communication around ACP. Methods This was a three-phase study. In phase 1, we used the nominal group and Delphi techniques to achieve expert consensus regarding the conceptual content of the tool. In phase 2, a professional cartoonist was commissioned to create a series of cartoons representing each of the content areas resulting from the Delphi process. The pictorial tool was then administered (phase 3) with a sample of individuals with advanced/chronic disease to explore whether the cartoons were easy to understand and conveyed the intended message. Results Following a three-round Delphi process, consensus was reached regarding a set of 12 key content areas that should be considered in the context of an ACP interview. The cartoons created to represent each of the 12 areas were then reviewed and ordered so as to reflect the typical stages of an end-of-life care interview. After administering the pictorial tool with 24 frail older adults with advanced/chronic disease, changes were made to 9 of the 12 cartoons. Conclusions The new pictorial tool comprises a set of 12 cartoons that can guide professionals as they seek to engage frail older adults with advanced/chronic disease in conversations about the end of life and ACP. [ABSTRACT FROM AUTHOR]

Background Topical agents are an essential component of psoriasis therapy. Objectives To develop a new version of the patient-reported Patient Benefit Index assessing the importance and achievement of treatment goals in topical psoriasis therapy in adult patients (PBI-TOP). Methods Through semi-structured interviews, focus groups and free-text questionnaires, patients reported their needs in topical treatment. Based on qualitative content analysis, items were developed by a consensus group and were refined in cognitive debriefing interviews. A pilot validation assessed the PBI-TOP and convergent criteria [Dermatology Life Quality Index (DLQI); Psoriasis Area and Severity Index (PASI); affected Body Surface Area (BSA)]. Results Thirty patients (26–72 years, mean 47; 60% male) reported various treatment goals relating to the themes 'effectiveness' and 'characteristics of the preparation'. Twenty patients took part in cognitive debriefings (22–84 years, mean 50.6, 50% male). There were 154 patients who participated in the pilot validation (18–85 years, mean 46.9, 63.6% male). An importance-weighted total score on overall effectiveness and three subscales based on exploratory factor analysis were defined: effectiveness on symptoms, effectiveness on quality of life (QoL), and characteristics of the preparation. All scores showed excellent internal consistency (α > 0.9). The global effectiveness score correlated significantly with DLQI (r = –0.41), PASI (r = –0.32) and BSA (r = –0.22). The effectiveness subscales (symptoms; QoL) correlated significantly with DLQI (r = –0.41; –0.32) and PASI (r = –0.27; –0.33). The score on characteristics of the preparation correlated significantly with the DLQI (r = –0.34). Conclusions The PBI-TOP showed good feasibility and favourable psychometric characteristics in this pilot validation. [ABSTRACT FROM AUTHOR]

Background Adolescent and young adult (AYA) survivors of a central nervous system (CNS) tumor represent a vulnerable group who can experience: social isolation, low rates of employment, and achieving independence can be compromised, leading to poorer quality of life compared with survivors of other cancer types. The aim of this study is to develop and evaluate the validity of a needs assessment tool (NAT) for AYA survivors of a CNS tumor. Methods Items generated using data from 29 qualitative studies and cognitive interviews (n = 8) produced NAT V1.1 (49 items). 128 of 316 eligible participants attending neuro-oncology clinics at 4 NHS sites between June 2022 and March 2023 completed the NAT V1.1 to allow for item reduction and refinement and to evaluate reliability and validity. A pilot study (n = 6) using YOU-CAN in routine follow-up concluded the study. Results Hierarchical analysis and Rasch analysis identified 18- and 15-items for removal, respectively. YOU-CAN, comprised of the remaining 16 items, demonstrates excellent test-retest reliability (intra-class correlation coefficient, 0.901, n = 40) and sufficient correlation with the European Quality of Life questionnaire and Supportive Care Needs Survey (Pearson r  = 0.433 and 0.590, respectively). Pilot testing showed YOU-CAN triggered discussions of unmet needs in consultations and highlighted the importance of multidisciplinary support. Conclusions YOU-CAN is a valid and reliable instrument containing items related to concerns about physical and emotional health; family and relationships; self-acceptance; and independence. Future efforts should examine YOU-CAN's feasibility, and develop guidance for managing unmet needs. Routine use of YOU-CAN may improve the identification of otherwise undiscussed unmet needs and opportunities to deliver personalized support. [ABSTRACT FROM AUTHOR]

Background Social isolation is prevalent and associated with dementia, yet the directionality and mechanisms are less understood. This study examined the association between social isolation and cognitive functioning and explored the mediating role of sleep disturbance on the social isolation–cognition relationship. Methods Data from 5 753 dementia-free Americans aged ≥50 of 2006 (T1), 2010 (T2), and 2014 (T3) waves of the Health and Retirement Study. Social isolation was measured by the Steptoe Social Isolation Index. Cognitive functioning was measured by the Telephone Interview of Cognitive Status. Sleep disturbance was measured with the modified Jenkins Sleep Scale. We used cross-lagged panel models to determine the associations between social isolation, sleep disturbance, and cognitive functioning. Results Social isolation is significantly associated with subsequent cognitive functioning (T1 to T2: β = −0.055, standard error [ SE ] = 0.014, p <.001; T2 to T3: β = −0.044, SE  = 0.016, p <.001). Lower cognitive functioning is significantly associated with greater subsequent social isolation (T1 to T2: β = −0.101, SE  = 0.020, p <.001; T2 to T3: β = −0.058, SE  = .011, p <.001). Sleep disturbance at T2 partially mediated the effect of social isolation (T1) on cognitive functioning (T3), accounting for 6.2% of the total effect (β = −0.003, SE  = 0.001, p <.01). Conclusions Social isolation may deteriorate cognitive functioning and vice versa. The association between social isolation and cognition is partially explained by sleep disturbance. [ABSTRACT FROM AUTHOR]

Background Loneliness precedes the onset of cognitive impairment (CI) in older adults. Although the mechanisms through which loneliness "gets under the skin" to influence the risk of developing CI have been conceptually proposed, they are rarely empirically examined. The Evolutionary Theory of Loneliness posits that loneliness as a stressor could cause dysregulations in multiple physiological systems. The current study investigated whether inflammatory, cardiovascular, and kidney biomarkers mediate the longitudinal association between loneliness and CI. Methods Cross-lagged panel models were used to examine the hypothesized relationships, using 2006, 2010, and 2014 waves of data from the Health and Retirement Study (N = 7,037). Loneliness was measured with the 3-item UCLA loneliness scale. CI was assessed with the modified telephone interview for cognitive status. Biomarkers included HbA1C, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, C-reactive protein, and Cystatin C. Using a stepwise model-building approach, first, the model included only loneliness, CI, and biomarker variables; then, sociodemographic covariates were added; lastly, health status were controlled for. Results In unadjusted and partially adjusted models, loneliness was associated with higher odds of worse cognitive status in an 8-year follow-up. Only HbA1C mediated the longitudinal association between loneliness and CI. However, after further controlling for health status, all associations became nonsignificant. Conclusions Examining a large number of participants and linking a limited number of biological markers with cognition and loneliness longitudinally, our empirical data did not support theoretical propositions, highlighting the critical importance of controlling for confounders in future studies examining longitudinal mediational relationships underlying loneliness and CI. [ABSTRACT FROM AUTHOR]

Background Cancer and dementia are becoming increasingly common co-occurring conditions among older adults. Yet, the influence of participant cognitive status on the validity of self-reported data among older adults in population-based cohorts is unknown. We thus compared self-reported cancer diagnoses in the U.S. Health and Retirement Study (HRS) against claims from linked Medicare records to ascertain the validity of self-reported diagnoses by participant cognitive and proxy interview status. Methods Using data from HRS participants aged ≥67 who had at least 90% continuous enrollment in fee-for-service Medicare, we examined the validity of self-reported first incident cancer diagnoses from biennial HRS interviews against diagnostic claim records in linked Medicare data (reference standard) for interviews from 2000 to 2016. Cognitive status was classified as normal, cognitive impairment no dementia (CIND), or dementia using the Langa–Weir method. We calculated the sensitivity, specificity, and κ for cancer diagnosis. Results Of the 8 280 included participants, 23.6% had cognitive impairment without dementia (CIND) or dementia, and 10.7% had a proxy respondent due to an impairment. Self-reports of first incident cancer diagnoses for participants with normal cognition had 70.2% sensitivity and 99.8% specificity (κ = 0.79). Sensitivity declined substantially with cognitive impairment and proxy response (56.7% for CIND, 53.0% for dementia, 60.0% for proxy respondents), indicating poor validity for study participants with CIND, dementia, or a proxy respondent. Conclusions Self-reported cancer diagnoses in the U.S. HRS have poor validity for participants with cognitive impairment, dementia, or a proxy respondent. Population-based cancer research among older adults will be strengthened with linkage to Medicare claims. [ABSTRACT FROM AUTHOR]

Background Patient-reported outcome measures for sexual health were often designed for research studies that included only heterosexual, partnered, and cisgender participants; as such, they may have limited applicability for clinical use among sexual and gender minority (SGM) individuals or those without a partner. Aim We aimed to conduct cognitive interviews with SGM persons and heterosexual women to determine the readability, comprehension, and applicability of questionnaire items to assess sexual function among diverse sexual and gender identities. Methods We conducted 4 rounds of cognitive interviews with 52 participants (28 SGM; 24 cisgender, heterosexual) who provided feedback on the comprehension and wording of questionnaire items and response scales. We used items from the Female Sexual Function Index (FSFI) and focused on establishing content validity of a modified measure. Participants made recommendations for changes to the questionnaire, which was iteratively revised between interview rounds. Two independent coders analyzed the transcripts using structural coding based on 5 predefined codes: satisfaction with item, specificity/language change needed, missing/suggested item, patient definitions of concepts, and confusion with item. Outcomes Content validity. Results After 3 rounds of cognitive interviews and revisions to the questionnaire, participants found the final version acceptable and understandable, thereby reaching thematic saturation and establishing content validity of the modified FSFI. Modifications included the following: replacing all instances of "sexual stimulation" and "intercourse" with "sexual activity (alone or with a partner)," broadening the definition of "vaginal penetration" beyond penile-vaginal penetration, and adding skip logic to include the option "no sexual activity." Participants identified missing concepts important to their sexual health, such as use of an external lubricant. Clinical Implications The FSFI and similar questionnaires need to be adapted to broader clinical practice populations such that all persons' experiences are accurately reflected and assessed, ensuring that sexual health needs can be met more inclusively. Strength and Limitations A strength of the study was using cognitive interviews engaging patient perspectives, which is considered the gold standard for establishing content validity. One limitation is that participants included predominantly White and highly educated women. Conclusion Feedback from interviews supports modifying FSFI items and further psychometric testing, and future studies should evaluate the measure among racially and educationally diverse groups. [ABSTRACT FROM AUTHOR]

Although delirium is a significant clinical and public health problem, little is understood about how specific vulnerabilities underlie the severity of its presentation. Our objective was to quantify the relationship between baseline cognition and subsequent delirium severity. We prospectively investigated a population-representative sample of 1510 individuals aged ≥70 years, of whom 209 (13.6%) were hospitalized across 371 episodes (1999 person-days assessment). Baseline cognitive function was assessed using the modified Telephone Interview for Cognitive Status, supplemented by verbal fluency measures. We estimated the relationship between baseline cognition and delirium severity [Memorial Delirium Assessment Scale (MDAS)] and abnormal arousal (Observational Scale of Level of Arousal), adjusted by age, sex, frailty and illness severity. We conducted further analyses examining presentations to specific hospital settings and common precipitating aetiologies. The median time from baseline cognitive assessment to admission was 289 days (interquartile range 130 to 47 days). In admitted patients, delirium was present on at least 1 day in 45% of admission episodes. The average number of days with delirium (consecutively positive assessments) was 3.9 days. Elective admissions accounted for 88 bed days (4.4%). In emergency (but not elective) admissions, we found a non-linear U-shaped relationship between baseline global cognition and delirium severity using restricted cubic splines. Participants with baseline cognition 2 standard deviations below average (z -score = −2) had a mean MDAS score of 14 points (95% CI 10 to 19). Similarly, those with baseline cognition z -score = + 2 had a mean MDAS score of 7.9 points (95% CI 4.9 to 11). Individuals with average baseline cognition had the lowest MDAS scores. The association between baseline cognition and abnormal arousal followed a comparable pattern. C-reactive protein ≥20 mg/l and serum sodium <125 mM/l were associated with more severe delirium. Baseline cognition is a critical determinant of the severity of delirium and associated changes in arousal. Emergency admissions with lowest and highest baseline cognition who develop delirium should receive enhanced clinical attention. [ABSTRACT FROM AUTHOR]

STUDY QUESTION Is it possible to design an ART Treatment Planning and Continuation Intervention (TPCI) that is considered acceptable and feasible to patients and healthcare professionals (HCPs)? SUMMARY ANSWER HCPs and patients responded positively to the TPCI prototype and perceived it as an acceptable intervention to support patients to stay engaged with planned treatment, but some concerns were raised about the feasibility of using it in practice. WHAT IS KNOWN ALREADY People discontinue ART due to its psychological burden. Digital tools to support people undergoing ART are available but typically focus only on practical support rather than psychological support. Research about treatment continuation and multi-cycle planning indicates that cognitive factors (expectations, intentions, efficacy beliefs) should be targets of interventions designed to help patients engage with and continue treatment to meet their personal treatment plans and goals. However, it is not known whether this form of psychological support would be acceptable for HCPs and patients or feasible to implement in practice. STUDY DESIGN, SIZE, DURATION Qualitative cognitive interviews with HCPs and patients (May 2021). Patients were eligible if they had had a consultation to start a first/repeat stimulated IVF/ICSI cycle in the 8 weeks prior to recruitment, were aged 18 or older (upper age limit of 42 years for women) and fluent in English. Eligible HCPs were those employed by a fertility clinic who were responsible for delivering treatment planning consultations to patients. PARTICIPANTS/MATERIALS, SETTING, METHODS HCPs and patients were asked to think aloud while being exposed to and exploring the TPCI in one-to-one online cognitive interviews. The TPCI was designed to reduce treatment discontinuation via cognitive factors namely formation and maintenance of multi-cycle ART intentions and efficiency of decision-making during treatment, and continuation of treatment after an unsuccessful cycle (when recommended). To impact cognitive factors the TPCI comprised of two components: an expectation management and reasoning checklist for HCPs to use during planning consultations (TPCI Checklist) and a multi-feature cognitive support mobile application (TPCI App) for patients to use prior to and during treatment. After participants thought aloud while being exposed to the TPCI prototype (both components) they were asked open questions concerning their perceptions of the core components and activities on eight acceptability dimensions (e.g. acceptability, demand, integration). Interviews lasted between 40 and 90 min, were recorded, transcribed verbatim and analysed using thematic analysis. MAIN RESULTS AND THE ROLE OF CHANCE Thirteen HCPs and 13 patients participated in 25 online interviews. Thematic analysis using inductive and deductive coding generated 180 codes, grouped into 22 categories and synthesized into 9 themes. The themes showed that HCPs and patients provided positive feedback about the TPCI, perceiving it as a needed, acceptable and potentially effective way to forewarn patients of the possible need for multiple cycles, to provide patients with a sense of patient–clinic collaboration and support, and to bolster treatment intentions, all of which were perceived to contribute to reduced treatment discontinuation. HCPs perceived implementation of the TPCI Checklist to be challenging in its current length due to time pressures and clinic workload. Suggestions for enhancing the TPCI Checklist and App were provided, but none required critical changes to its core components or activities. LIMITATIONS, REASONS FOR CAUTION All patients were women recruited from social media websites, mainly associated with patient support groups, who may be highly committed to their fertility treatment. HCPs were predominantly from private fertility clinics. WIDER IMPLICATIONS OF THE FINDINGS The findings suggest there is demand for digital support geared towards motivational aspects of undergoing ART. The TPCI is an acceptable support tool to meet that need according to HCPs responsible for delivering planning consultations and patients undergoing fertility treatment. Future research is needed to develop the prototype and examine the feasibility of implementation of the TPCI in clinics. STUDY FUNDING/COMPETING INTEREST(S) This research was financially supported by Merck Serono Ltd, an affiliate of Merck KGaA, Darmstadt, Germany. 'Merck KGaA, Darmstadt, Germany reviewed the manuscript for medical accuracy only before journal submission. The authors are fully responsible for the content of this manuscript, and the views and opinions described in the publication reflect solely those of the authors' J.B. reports personal fees from Merck KGaA, Darmstadt, Germany, Merck AB an affiliate of Merck KGaA, Darmstadt Germany, Theramex, Organon JJC, Ferring Pharmaceuticals A/S, research grant from Merck Serono Ltd, grants from ESHRE outside the submitted work and that she is co-developer of Fertility Quality of Life (FertiQoL) and MediEmo app. S.G. reports consultancy fees from TMRW Life Sciences and Ferring Pharmaceuticals A/S, speaker fees from Access Fertility, SONA-Pharm LLC, Meridiano Congress International and Gedeon Richter. C.H. declares no conflicts of interest. TRIAL REGISTRATION NUMBER N/A. [ABSTRACT FROM AUTHOR]

Background: Recap of atopic eczema (RECAP) is a patient‐reported outcome measure assessing eczema control. This instrument has been developed and validated in the UK. There are self‐reported and proxy‐reported versions in English, Dutch and German. However, it is unclear whether the self‐reported version shows adequate content validity when completed by young people (8–16 years) in these languages. Objectives: To assess the content validity (comprehensibility, relevance and comprehensiveness) of the English, German and Dutch versions of the self‐reported RECAP in young people with atopic eczema and to identify the most appropriate age cutoff for self‐completion. Methods: We conducted 23 semistructured cognitive interviews with young people aged 8–16 years, using the 'think‐aloud' method. In Germany and the Netherlands, participants were recruited in dermatology clinics and in the UK through social media and existing mailing lists. Interviews were audio recorded, transcribed verbatim and analysed in the three languages, using a problem‐focused coding manual. Transcripts were coded by two independent reviewers in each country. Themes were translated into English and compared across the three countries. Results: Significant age‐related comprehensibility issues with the last three items of the questionnaire occurred with young people aged 8–11 years, causing difficulties completing RECAP without help. However, older children had only minor problems and were able to complete the questionnaire by themselves. The self‐reported version of RECAP has sufficient content validity for self‐completion in young people aged 12 years and above. However, the German version with some translational adaptations may be appropriate for children from the age of 8 years. There may be some situations where the proxy version is needed for older children too. Conclusions: The self‐reported version of RECAP is appropriate for use from the age of 12 years. The proxy version can be used in children younger than 12 years. Other measurement properties should be further investigated. What is already known about this topic?Recap of atopic eczema (RECAP) is an instrument recommended by the Harmonising Outcome Measures for Eczema initiative for the core outcome domain of long‐term control of atopic eczema.Content validity of RECAP for self‐completion by adults and of the proxy version has been assessed. What does this study add?In this study, content validity (comprehensibility, relevance and comprehensiveness) of the self‐reported version of RECAP among young people (aged 8–16 years) with atopic eczema across the UK, Germany and the Netherlands is assessed.Based on these findings, key recommendations on how to measure eczema control in young people with atopic eczema are formulated. What are the clinical implications of this work?The Dutch, English and German self‐completion versions of RECAP are recommended for use in adolescents from the age of 12 years.The proxy version could be used in children younger than 12 years or where children are cognitively or physically incapable of reporting their experience of eczema control.Caregivers should be encouraged to complete RECAP together with their child where possible. [ABSTRACT FROM AUTHOR]

Objective: Regular psychosocial assessment is a best-practice guideline for young adult oncology care, but multipurpose, multidimensional, developmentally appropriate patient-reported outcome measurement strategies for young adults with cancer are lacking. This study reported on the development and preliminary validation of the Young Adult Psychosocial Assessment Strategy (YA-PAS), a tool designed to meet this clinical need.Methods: The YA-PAS was developed based on the literature and clinician feedback. 20 young adults with cancer participated in cognitive interviews to provide feedback on complexity, readability, and applicability to inform measure refinement. Following refinements, 100 young adults with a history of cancer participated in an observational study including a preliminary evaluation of YA-PAS factor structure, internal consistency, test-retest reliability, construct and criterion validity, feasibility, and acceptability.Results: Cognitive interviews and psychometric evaluation informed modifications and resulted in a measure with 9 domains (anxiety, depression, cognitive functioning, post-traumatic stress, family stressors, support, social isolation, self-efficacy for symptom management, and self-efficacy for medication management) and nonscoring items assessing substance use, life stressors, resources, educational/vocational status, and relationship status. 8 of 9 domains demonstrated acceptable internal consistency (Cronbach's α ≥ 0.70), substantial (r = 0.61-0.80) or almost perfect (r > 0.80) test-retest reliability, and evidence of domain and cut-point validity. 89% of participants were able to complete the YA-PAS within 20 min and 87% were satisfied with the measure.Conclusions: The YA-PAS demonstrated promising psychometric properties, feasibility, and acceptability. Clinical implications and research recommendations are discussed. [ABSTRACT FROM AUTHOR]

Background Patient experience is a recognized aspect of quality of care for people with chronic kidney disease (CKD), but current patient-reported experience measures (PREMs) only focus on dialysis care. We developed and validated the Kidney PREM to assess patients' experience with renal services in secondary care for any CKD stage or treatment (transplant, haemodialysis and peritoneal dialysis). Methods We developed the Kidney PREM in two phases, informed by a multidisciplinary expert group to ensure face validity. We organized three national data collections (2016–8) to investigate item response profiles and to conduct exploratory and confirmatory analyses to assess internal consistency. We also explored content validity in cognitive interviews and evaluated test–retest reliability. Finally, we developed the Kidney PREM Short Form for more frequent measurement of patient experience to inform local service improvements. Results We analysed 32   959 responses across data collections, with the 2018 collection covering all 71 UK renal centres. The Kidney PREM final version consisted of 38 items grouped into 13 themes, all pertaining to one underlying dimension reflecting the construct of 'patient experience' with high internal consistency (Cronbach's α = 0.94). The Kidney PREM Short Form consisted of 15 items across the same 13 themes. Conclusions The Kidney PREM supports the collection of reliable information on patient experience that people with CKD consider relevant, regardless of CKD stage or treatment modality. Kidney PREM data have the potential to guide local and national initiatives to improve patients' experiences with renal services in the UK and other countries. [ABSTRACT FROM AUTHOR]

Objective: Provide an overview of the Patient-Reported Outcomes Measurement Information System (PROMIS®) Early Childhood Parent Report measurement development project and describe its qualitative methods.Methods: The PROMIS Early Childhood (PROMIS EC) initiative used the PROMIS mixed-methods approach to patient-reported outcome development, with insight from the developmental specification framework to create parent report measures appropriate for assessing young children's health-related quality of life. Qualitative methods to develop these instruments included expert input, literature and measure review, and parent concept elicitation and cognitive interviews to confirm the measure frameworks, item understandability, and developmental appropriateness.Results: Twelve measures resulted from the PROMIS EC initiative. These parent report instruments cover young children's physical, mental, and social health.Conclusions: The new PROMIS EC Parent Report instruments offer clinicians and researchers brief and psychometrically robust tools to evaluate young children's physical, mental, and social health outcomes. Aligned with the PROMIS Pediatric instruments, the early childhood versions enable coherent lifespan measurement starting at age 1 while maintaining developmental sensitivity. [ABSTRACT FROM AUTHOR]

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. 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. 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. The SexFS as originally published functioned well in people with MS after minor modifications. 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. Brief and Full profiles are freely available and are recommended for research and clinical practice that include people with MS. 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. 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. [ABSTRACT FROM AUTHOR]

Summary: Background: The content validity (appropriateness and acceptability) of patient‐reported outcome (PRO) measures for scalp hair loss, eyebrow loss, eyelash loss, nail damage and eye irritation has been demonstrated in adults with alopecia areata (AA) but not adolescents. Objectives: To explore the content validity of the suite of AA PRO measures and accompanying photoguides in an adolescent sample. Methods: Semi‐structured, 90‐min, combined concept elicitation and cognitive interviews were conducted face‐to‐face with adolescents who experienced ≥ 50% AA‐related scalp hair loss. Transcripts underwent thematic and framework analysis. Results: Eleven adolescents (aged 12–17 years, 55% female, 45% nonwhite) diagnosed with AA for 5·9 years (mean) participated. Participants had 69·6% scalp hair (mean) and current eyebrow (82%) and/or eyelash loss (82%) and/or nail involvement (36%). Adolescents reported scalp, eyebrow and eyelash hair loss as their top three most bothersome signs/symptoms. Despite mostly accepting their AA, impacts related to visible areas of hair loss were prominent. Participants demonstrated good understanding and appropriate use of the PRO measures, and advocated including hair loss percentages alongside descriptive categories in the Scalp Hair Assessment PRO™. Results confirmed treatment success thresholds established with adults: achievement of ≤ 20% scalp hair loss, no/minimal eyebrow and eyelash loss, no/a little nail damage and eye irritation (PRO measure categories 0 or 1). Conclusions: The Scalp Hair Assessment PRO™, PRO Measure for Eyebrows™, PRO Measure for Eyelashes™, PRO Measure for Nail Appearance™ and PRO Measure for Eye Irritation™ and accompanying photoguides are fit‐for‐purpose self‐reported measures of AA signs/symptoms that are impactful to adolescents with AA. Linked Comment: T.M. Klein. Br J Dermatol 2022; 186:763–764. Plain language summary available online [ABSTRACT FROM AUTHOR]

Background: The apolipoprotein E (APOE) e4 allele is a well-established genetic risk factor of brain aging. Vigorous physical activity may be particularly important in APOE-e4 carriers, but data have been inconsistent, likely due to differences in the timing of the physical activity assessment, definition of cognitive decline, and/or sample size.Methods: We prospectively evaluated the association between vigorous physical activity and cognition assessed at least 9 years later, according to APOE-e4 carrier status. Biennially from 1986, Nurses' Health Study participants reported their leisure-time physical activities. Starting in 1995-2001 and through 2008, participants (aged 70+ years) underwent up to 4 repeated cognitive telephone assessments (6 tasks averaged together using z-scores).Results: Among 7252 women, latent process mixed models identified 3 major patterns of cognitive change over 6 years: high-stable, medium-stable, and decline. Taking the high-stable cognitive trajectory as the outcome reference in multinomial logistic regressions, highest tertile of vigorous physical activity (≥5.9 metabolic-equivalent [MET]-hours/wk) compared to lowest tertile (≤0.9 MET-hours/wk) was significantly associated with subsequent lower likelihood of the medium-stable trajectory in the global score (odds ratio [OR] [95% CI] = 0.72 [0.63, 0.82]), verbal memory (OR [95% CI] = 0.78 [0.68-0.89]), and telephone interview of cognitive status score (OR [95% CI] = 0.81 [0.70-0.94]). Vigorous physical activity was also associated with lower likelihood of decline in category fluency (OR [95% CI] = 0.72 [0.56, 0.92]). We observed some evidence (p-interaction = .07 for the global score) that the association was stronger among APOE-e4 carriers than noncarriers (OR [95% CI] = 0.60 [0.39, 0.92] vs 0.82 [0.59, 1.16]).Conclusion: Midlife vigorous physical activity was associated with better cognitive trajectories in women in their seventies, with suggestions of stronger associations among APOE-e4 carriers. [ABSTRACT FROM AUTHOR]

Background We previously conducted a concept elicitation study on the impact of S taphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) on health-related quality of life (HRQoL) from the patient's perspective and found significant impacts on HRQoL, particularly in the physical and functional domains. Using this information and following guidance on the development of patient-reported outcome (PRO) measures, we determined which combination of measures and items (ie, specific questions) would be most appropriate in a survey assessing HRQoL in bloodstream infections. Methods We selected a variety of measures/items from the Patient-Reported Outcomes Measurement Information System (PROMIS) representing different domains. We purposefully sampled patients ~6–12 weeks post-SAB/GNB and conducted 2 rounds of cognitive interviews to refine the survey by exploring patients' understanding of items and answer selection as well as relevance for capturing HRQoL. Results We interviewed 17 SAB/GNB patients. Based on the first round of cognitive interviews (n = 10), we revised the survey. After round 2 of cognitive interviewing (n = 7), we finalized the survey to include 10 different PROMIS short forms/measures of the most salient HRQoL domains and 2 adapted questions (41 items total) that were found to adequately capture HRQoL. Conclusions We developed a survey from well-established PRO measures that captures what matters most to SAB/GNB patients as they recover. This survey, uniquely tailored to bloodstream infections, can be used to assess these meaningful, important HRQoL outcomes in clinical trials and in patient care. Engaging patients is crucial to developing treatments for bloodstream infections. [ABSTRACT FROM AUTHOR]

Patient-reported outcome instruments to assess sexual functioning typically assume that patients are heterosexual and have a single sexual partner, thus they may have limited applicability for sexual and gender minority (SGM) populations as well as for nonpartnered individuals or those with multiple partners. To explore the perceptions of SGM persons regarding the Female Sexual Function Index (FSFI), a commonly used sexual functioning questionnaire. We conducted 2 rounds of cognitive interviews with 27 SGM persons with and without a cancer diagnosis. Interviews were audio-recorded and transcribed. Two researchers independently coded the transcripts using inductive thematic analysis to identify major themes. Themes identified via qualitative analysis. Cognitive debriefing with the participants provided critical insights about the way we ask questions about sexual functioning in the oncology clinic. Three overarching themes arose from the data: (i) Certain aspects of the questionnaire were felt to unnecessarily medicalize sexuality; (ii) FSFI domains were perceived to represent a narrow and heteronormative experience of sexuality focused on penile-vaginal intercourse; (iii) Questionnaire domains emphasizing sexual "performance" were perceived as male-oriented. Questionnaires such as the FSFI that were developed in research studies with specific eligibility criteria need to be adapted to the broader population seen in clinical practice. Strengths of the study include purposive sampling of SGM persons through LGBTQ networks. Our sample included individuals of different sexual orientations, gender identities, marital status, and cancer histories. However, a limitation is that the the majority of the sample was white and college-educated. Other limitations of the study include the potential sampling bias of self-selected participants with a particular interest in the study questions. The findings provide important evidence for the development of a more inclusive sexual function measure, moving away from the traditional heteronormative, cisnormative approach to measuring sexual function. Austria MD, Lynch K, Le T, et al. Sexual and Gender Minority Persons' Perception of the Female Sexual Function Index. J Sex Med 2021;18:2020–2027. [ABSTRACT FROM AUTHOR]

Summary: Background: Shared decision‐making tools (SDMt) are visual tools developed to promote joint medical decisions between physicians and patients. There is a paucity of such tools in dermatology. Objectives: To develop and validate a SDMt for use in specialized consultation for vitiligo. Methods: A prospective cross‐sectional study was carried out from March 2019 to March 2020. We first conducted a qualitative study of topics discussed by patients and clinicians during therapeutic decision‐making in the setting of a specialized consultation for vitiligo using an anchored‐theory method, which allowed conceptualization of the SDMt. The usefulness of the SDMt was evaluated by a working group of multidisciplinary health workers and patients with vitiligo. Consensus on the final tool was obtained through an e‐Delphi method. Results: We recruited 30 patients with vitiligo for the qualitative study, which identified 91 topics related to therapeutic decision‐making. Hierarchical clustering analysis confirmed the distribution of these topics in two subgroups (general treatment goals and priorities, and topics specific to each treatment). The consensus of a multidisciplinary group was used to develop the SDMt. The tool was comprised of eight A5 cards, which addressed face repigmentation; body repigmentation (limited area); body repigmentation (extended area); partial or complete depigmentation; coping with the disease; stabilization of disease; maintaining repigmentation; and disease information. Cognitive interviews confirmed the satisfaction, readability and usefulness of the SDMt. The SDMt was then translated and culturally validated in English. Conclusions: We developed a tool for shared decision‐making in nonsegmental vitiligo, which we translated and cross‐culturally validated in a US patient population with vitiligo to ensure its generalizability. What is already known about this topic?Therapeutic management in vitiligo is often challenging and requires long‐term adherence.Shared decision‐making tools (SDMt) are visual aids that may help patients better define what they would like to achieve in terms of treatment.In dermatology, there have been various decision support tools developed but none for vitiligo. What does this study add?We developed a SDMt that was tested in 30 French and 10 US adult patients with vitiligo who reported high satisfaction rates with the use of this tool during consultation.This SDMt for vitiligo may help patients better define how they would like to improve their adherence to treatment and what they consider successful in terms of treatment. What are the clinical implications of this work?The SDMt for vitiligo can be used routinely in daily clinical practice, which may help to increase patient adherence to treatment. Plain language summary available online [ABSTRACT FROM AUTHOR]

Cognitive interviewing is a qualitative research method for improving the validity of quantitative surveys, which has been underused by academic researchers and monitoring and evaluation teams in global health. Draft survey questions are administered to participants drawn from the same population as the respondent group for the survey itself. The interviewer facilitates a detailed discussion with the participant to assess how the participant interpreted each question and how they formulated their response. Draft survey questions are revised and undergo additional rounds of cognitive interviewing until they achieve high comprehension and cognitive match between the research team's intent and the target population's interpretation. This methodology is particularly important in global health when surveys involve translation or are developed by researchers who differ from the population being surveyed in terms of socio-demographic characteristics, worldview, or other aspects of identity. Without cognitive interviewing, surveys risk measurement error by including questions that respondents find incomprehensible, that respondents are unable to accurately answer, or that respondents interpret in unintended ways. This methodological musing seeks to encourage a wider uptake of cognitive interviewing in global public health research, provide practical guidance on its application, and prompt discussion on its value and practice. To this end, we define cognitive interviewing, discuss how cognitive interviewing compares to other forms of survey tool development and validation, and present practical steps for its application. These steps cover defining the scope of cognitive interviews, selecting and training researchers to conduct cognitive interviews, sampling participants, collecting data, debriefing, analysing the emerging findings, and ultimately generating revised, validated survey questions. We close by presenting recommendations to ensure quality in cognitive interviewing. [ABSTRACT FROM AUTHOR]

Background The complexity of disease- and treatment-related symptoms causes profound distress and deterioration of health-related quality of life among patients with brain tumors. Currently, there is no Danish validated disease-specific instrument that focuses solely on measures of both neurologic and cancer-related symptoms of patients with brain tumors. The MD Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) is a validated patient self-report questionnaire that measures symptom prevalence, intensity, and interference with daily life. The aim of the present study was to determine the psychometric validity of the Danish translation of the MDASI-BT, and to test its utility in 3 cohorts of Danish patients across the spectrum of the brain cancer disease and treatment trajectory. Methods A linguistic validation process was conducted. Danish patients with malignant primary brain tumors were included to establish the psychometric validity and reliability of the Danish MDASI-BT. Cognitive debriefing interviews were conducted to support the psychometric properties. Results A total of 120 patients participated in this study. Coefficient αs for the symptom and interference subscales indicate a high level of reliability across all items. Corresponding symptom and interference or functional items and subscales in the MDASI-BT and European Organisation for Research and Treatment of Cancer Brain Tumor Module BN20 were significantly correlated. Cognitive debriefing provided evidence for content validity and questionnaire utility as participants were comfortable answering the questions and had no problem with the understandability or number of questions asked. Conclusion The MDASI-BT is a simple, concise symptom assessment tool useful for assessing the symptom severity and interference of Danish-speaking patients with brain cancer. [ABSTRACT FROM AUTHOR]

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory disease. The HS core outcome set calls for a patient global assessment (PtGA). Objectives: To assess the validity, reliability and responsiveness of a candidate single‐item PtGA for HS‐specific health‐related quality of life (HRQoL). Methods: Cognitive debriefing interviews were conducted with patients with HS in Denmark and the USA. A cross‐sectional observational study was done with adults with HS in the USA and Denmark. Candidate PtGA item, demographic items and multiple patient‐reported scales – the Hidradenitis Suppurativa Quality of Life (HiSQOL), Dermatology Life Quality Index (DLQI) and numerical rating scale (NRS) for pain – were concurrently administered to evaluate convergent and known‐groups validity. Scales with a single‐item assessment of change were readministered 24–72 h later, to evaluate reliability and responsiveness. Results: After cognitive debriefing, the candidate PtGA for HS‐specific HRQoL was finalized with five response levels. Convergent validity of the PtGA was supported by significant correlations with HiSQOL score [r = 0·79, 95% confidence interval (CI) 0·75–0·82] and DLQI (r = 0·78, 95% CI 0·74–0·82). The PtGA displayed known‐groups validity with DLQI score bands based on significance of an anova (P < 0·001). Good test–retest reliability was supported by the intraclass correlation coefficient (0·82, 95% CI 0·78–0·85) for those who reported stable HS. Responsiveness was assessed by differences in PtGA score against a patient‐reported assessment of change, which showed significant differences towards improvement. Conclusions: The single‐item PtGA exhibits reliability, validity and responsiveness in assessing HS‐specific HRQoL in HS, making it a good provisional tool for HS clinical research. What is already known about this topic? Hidradenitis suppurativa (HS) can have a large negative impact on health‐related quality of life (HRQoL).Patient global assessments are useful in eliciting important aspects of the patient's perspective on an individual basis.Few studies have developed and investigated the measurement properties of a patient global assessment (PtGA) item for HS. What does this study add? This study describes the development, validation and psychometric properties of a PtGA item for HS.This PtGA item for HRQoL shows promise with its validity and reliability, allowing for its further development as a clinical research tool. What are the clinical implications of this work? The PtGA item can now be investigated longitudinally in a treated population to further elucidate the responsiveness, minimally important change and score bands. [ABSTRACT FROM AUTHOR]

Pruritus is a commonly reported symptom after burn injury. Valid and reliable scales to measure itch in pediatric burn survivors are important for treatment and epidemiological studies. This study sought to develop psychometrically sound, publicly available self- and proxy-report measures of itch for use in pediatric burn survivors suitable for use in research and clinical practice. A panel of burn experts developed a definition of itch interference and a set of parallel self- and proxy-report candidate items that covered important activities affected by itch. Candidate items were evaluated in cognitive interviews with pediatric burn survivors (n = 4) and proxies (n = 2). Items were translated to Spanish and administered in both English and Spanish to a sample (N = 264) of pediatric burn survivors and/or their proxy enrolled in the Burn Model System (BMS) longitudinal database. The mean age of the pediatric sample was 13 years and average time since burn 5 years. The final itch interference measures each included 5 parallel items calibrated using a one-parameter graded response item response theory model, with a mean of 50 representing the average itch interference of the sample. Reliability of the scores is excellent between the mean and two standard deviations above. Initial analyses provide support for validity of the score. Concordance between the self- and proxy-report scores was moderate (ICC = 0.68). The results support the reliability and validity of the itch scale in children and youth with burn injury. The new BMS Pediatric Itch Interference scales are freely and publicly available at https://burndata.washington.edu/itch. [ABSTRACT FROM AUTHOR]

Introduction: After a vehicle rollover led to the death of a military member in Central Africa in 2018, it became apparent there was a significant gap in the capability to collect toxicology samples of Service Members involved in accidents and mishaps at remote Special Operations Forces locations in Africa. Multiple misconceptions surrounding sample collection, procedures for laboratory evaluation, and methods for shipment signaled the importance of establishing a procedure and a plan to provide the necessary medical inventory to properly collect and ship samples.Materials and Methods: The Special Operations Command Africa (SOCAFRICA) Surgeon's Office gathered the appropriate supplies for collection of forensic toxicology samples, and simultaneously developed a step-by-step checklist to safely and correctly perform urine and blood collection. The procedures were further improved after the completion of cognitive interviews with a Navy corpsman and Army Civil Affairs medic. Multiple shipping iterations occurred to ensure safe movement and arrival of samples at Armed Forces Medical Examiner System Dover AFB. Two Separate Specimens for Accident Forensic Toxicology Investigation Kits were generated to accommodate personnel typically associated with accidents involving vehicles and aircraft.Results: SOCAFRICA's toxicology kit supports legal and medical chain of custody requirements for investigations, and provides deployed forces in Africa with a mechanism to collect and ship samples from Africa to Dover AFB. The kits are provided to ensure these samples are successfully analyzed, thereby removing any ambiguity surrounding an accident or mishap.Conclusion: SOCAFRICA established a prepared kit with all of the materials for sample collection, accompanied by step-by-step descriptions of the procedure, and clear guidance on the proper completion of the requisite paperwork that meets medico-legal requirements. [ABSTRACT FROM AUTHOR]

Vulvodynia is defined as vulvar pain of at least 3 months duration without a clear identifiable cause. There are currently no validated questionnaires that assess the experience of women with localized vulvodynia of the vestibule (vestibulodynia, previously known as vulvar vestibulitis) that meet the requirements of the Food and Drug Administration's Patient Reported Outcome (PRO) Guidance. To develop a new content-valid PRO assessment in accordance with the Food and Drug Administration's PRO guidance to assess the symptoms and impacts of localized vulvodynia. Participants were recruited for concept elicitation interviews (ie, interviews with open-ended questions with the goal of eliciting volunteered data about the symptoms and impacts of vulvodynia). Participants were identified as having localized vulvodynia by clinicians who were experts in treating vulvar disorders. Eligibility was confirmed by the recruiting clinician, and informed consent was obtained; participants were then scheduled for in-person interviews. 25 participants were interviewed from United States (US). After concept elicitation interviews, the draft Vulvodynia Experience Questionnaire (VEQ) was developed based on the results. Cognitive interviews were conducted with 20 participants from US sites to assess the content validity of the VEQ (eg, interpretation and clarity of the items, relevance of concepts). The VEQ was further revised after cognitive interviews. All interviews were conducted face-to-face, audio-recorded, transcribed verbatim, anonymized, and analyzed using a qualitative data analysis software program. 17 unique symptoms and 32 unique impacts were reported during concept elicitation interviews. Pain (n = 25, 100%) and burning (n = 24, 96%) were the most frequently reported symptoms of localized vulvodynia, and negative impact on emotional well-being (n = 25, 100%) was the most frequently reported impact. After analysis, item generation, and cognitive interviews, the resulting VEQ v2.0 contains 3 parts (part 1, pain; part 2, associated symptoms; part 3, impacts) with a total of 25 items that measure the most frequently reported symptoms and impacts of localized vulvodynia. The VEQ is a multidimensional assessment of the core symptoms and impacts of localized vulvodynia that, after additional psychometric testing including the ability to detect change, may be used in clinical trials to characterize the benefits of novel treatments. The VEQ requires additional testing to establish its cultural relevance and linguistic validity in other countries. The VEQ is a novel method of collecting information on localized vulvodynia symptoms and impacts that may be suitable for use in clinical trials after psychometric testing. Goldstein AT, Diez P M Q, Kapanadze S, et al. The Vulvodynia Experience Questionnaire: Qualitative Development of a New Patient-Reported Outcome Measure for Vulvodynia. J Sex Med 2020;17:2055–2066. [ABSTRACT FROM AUTHOR]

Background Dialysis care often focuses on outcomes that are of lesser importance to patients than to clinicians. There is growing international interest in individualizing care based on patient priorities, but evidence-based approaches are lacking. The objective of this study was to develop a person-centered dialysis care planning program. To achieve this objective we performed qualitative interviews, responsively developed a novel care planning program and then assessed program content and burden. Methods We conducted 25 concept elicitation interviews with US hemodialysis patients, care partners and care providers, using thematic analysis to analyze transcripts. Interview findings and interdisciplinary stakeholder panel input informed the development of a new care planning program, My Dialysis Plan. We then conducted 19 cognitive debriefing interviews with patients, care partners and care providers to assess the program's content and face validities, comprehensibility and burden. Results We identified five themes in concept elicitation interviews: feeling boxed in by the system, navigating dual lives, acknowledging an evolving identity, respecting the individual as a whole person and increasing individualization to enhance care. We then developed a person-centered care planning program and supporting materials that underwent 32 stakeholder-informed iterations. Data from subsequent cognitive interviews led to program revisions intended to improve contextualization and understanding, decrease burden and facilitate implementation. Conclusions My Dialysis Plan is a content-valid, person-centered dialysis care planning program that aims to promote care individualization. Investigation of the program's capacity to improve patient experiences and outcomes is needed. [ABSTRACT FROM AUTHOR]

Summary: Background: Hidradenitis suppurativa (HS) is a chronic, inflammatory condition that can have a large negative impact on health‐related quality of life (HRQOL). A reliable and validated measure of HS‐specific HRQOL in clinical studies is needed. Objectives: To develop and validate the Hidradenitis Suppurativa Quality Of Life (HiSQOL©) scale, for clinical trial measurement of HS‐specific HRQOL. Methods: In stage 1, qualitative concept elicitation interviews were conducted with patients with HS in Denmark (n = 21) and the U.S.A. (n = 21). In stage 2, cognitive debriefing interviews were performed with U.S. (n = 30) and Danish patients with HS (n = 30). In stage 3 an observational study of 222 patients with HS in the U.S.A. was conducted for item reduction, measure validation and assessment of psychometric properties. In stage 4, an observational study of 215 patients with HS in Denmark was conducted to confirm the psychometric structure derived in stage 3. In both studies the Dermatology Life Quality Index, Hospital Anxiety and Depression Scale and numerical rating scale for pain were also included. Results: In concept elicitation, 99 items were generated, which were reduced to 41 after removing duplicates. In cognitive debriefing, two items were added and one item removed. A 42‐item instrument was psychometrically assessed. Based on psychometric analyses and patient input, the instrument was reduced to 17 items that had strong psychometric properties in both the U.S. and Danish samples. Conclusions: The HiSQOL is a reliable and valid instrument to measure HS‐specific HRQOL in clinical trials. What's already known about this topic? Hidradenitis suppurativa (HS) is a chronic, relapsing inflammatory skin condition with potential adverse impacts on health‐related quality of life (HRQOL).The ability to assess HS‐specific HRQOL is important to those with HS and in further research to mitigate the effects of the condition.Development of HS‐specific instruments is feasible, and existing instruments have limitations. What does this study add? This study describes the development, validation and psychometric properties of the HiSQOL, a novel HS‐specific HRQOL instrument.HiSQOL is a patient‐reported outcome measure developed for clinical trials to address disease‐specific changes in HRQOL. What are the clinical implications of this work? HiSQOL is acceptable and comprehensible, and has strong evidence for validity and reliability in assessing patient‐centred outcomes in clinical trials. [ABSTRACT FROM AUTHOR]

Objective: Stigma is associated with many health conditions, including chronic pain. Research on health-related stigma is limited by the lack of validated instruments that distinguish among various stigma-related constructs. We aimed to develop and validate such a measure for pediatric functional abdominal pain (FAP). Felt stigma (FS) was defined as comprising both perceived and internalized stigma. Stigma concealment (SC) was defined as efforts by stigmatized individuals to prevent others from learning of their condition.Methods: Using a theory-driven approach, we adapted items from existing self-report measures of stigma to construct the health-related FS and Concealment Questionnaire (FSC-Q). Patients with FAP (N = 179, ages 11-17) completed the preliminary FSC-Q and health-related measures hypothesized to be associated with stigma. Cognitive interviewing and exploratory factor analysis (EFA) informed the final version of the measure.Results: EFA identified a 2-factor model comprised of FS and SC. The FS and SC scales exhibited good internal consistency and construct validity. Consistent with study hypotheses, both factors were significantly associated with anxiety, depression, pain catastrophizing, pain threat, physical symptoms, and pain interference/disability. Higher FS was associated with higher mental healthcare utilization. The subset of participants meeting criteria for irritable bowel syndrome (IBS) reported higher FS and SC compared with those without IBS.Conclusion: The FSC-Q may help advance research on health-related stigma in FAP and other chronic health conditions by allowing for assessment of distinct stigma-related constructs. [ABSTRACT FROM AUTHOR]

Summary: Background: According to current standards, no existing patient‐reported outcome (PRO) measures have high‐quality validity evidence for use with individuals diagnosed with paediatric localized scleroderma (LS). This severely hinders patient‐centred LS‐focused research, including much needed clinical trials. Objectives: To develop a valid health‐related quality of life measure for individuals with paediatric LS and to qualitatively evaluate its content validity using a patient‐centred approach. Methods: Previously collected qualitative data from youth with LS and their caregivers was used to develop items. The resulting item set was administered in a clinical setting to participants aged 8–18 years old. Cognitive interviews were used to evaluate time to survey completion, readability/understanding of the items, appropriateness of the recall period and construct representation. Results: Seventeen children and adolescents with LS participated in the study. Interviews supported readability, understanding of the items and appropriateness of the recall period in individuals > 10 years old. Revisions were made to simplify the instructions and to be more inclusive of different subtypes of LS. Three items were added to improve content representation. Conclusions: Content validity was supported by the patient‐centred development process of the outcome measure and via direct feedback from individuals with LS and their families. Although an important first step, the resulting PRO, termed the Localized Scleroderma Quality of Life Instrument, should be further evaluated in a larger sample before being implemented. What's already known about this topic? No current health‐related quality of life (HRQoL) measures have been created using direct input from children and adolescents with localized scleroderma (LS).When compared with qualitative reports of HRQoL impact in youth with all LS subtypes, no existing patient‐reported outcome (PRO) measures have appropriate content validity for individuals with paediatric LS. What does this study add? This study proposes a novel LS‐specific PRO and is the first qualitative assessment of content validity for any PRO measure in this population.Results from cognitive interviews with children and adolescents support the content validity of the newly developed item set and its ability to capture HRQoL impact in a clinical context. What are the clinical implications of this work? Incorporating a content‐valid PRO of HRQoL impact into clinical practice would allow for the valid, ongoing capture of patient experience in LS.Although content validity is an important and necessary step in the process of evaluating validity, items within this novel measure will undergo additional psychometric evaluation before implementation in research and clinical settings. Linked Comment:Nelson. Br J Dermatol 2020; 182:529. Plain language summary available online [ABSTRACT FROM AUTHOR]

Quantitative survey findings are important in measuring health-related phenomena, including on sensitive topics such as respectful maternity care (RMC). But how well do survey results truly capture respondent experiences and opinions? Quantitative tool development and piloting often involve translating questions from other settings and assessing the mechanics of implementation, which fails to deeply explore how respondents understand survey questions and response options. To address this gap, we conducted cognitive interviews on survey questions (n = 88) adapted from validated RMC instruments used in Ethiopia, Kenya and elsewhere in India. Cognitive interviews with rural women (n = 21) in Madhya Pradesh, India involved asking the respondent the survey question, recording her response, then interviewing her about what the question and response options meant to her. We analysed the interviews to revise the tool and identify question failures, which we grouped into six areas: issues with sequencing, length and sensitivity; problematic response options; inappropriate vocabulary; temporal and spatial confusion; accessing different cognitive domains; and failure to resonate with the respondent's worldview and reality. Although women tended to provide initial answers to the survey questions, cognitive interviews revealed widespread mismatch between respondent interpretation and question intent. Likert scale response options were generally incomprehensible and questions involving hypothetical scenarios could be interpreted in unexpected ways. Many key terms and concepts from the international RMC literature did not translate well and showed low resonance with respondents, including consent and being involved in decisions about one's care. This study highlights the threat to data quality and the validity of findings when translating quantitative surveys between languages and cultures and showcases the value of cognitive interviews in identifying question failures. While survey tool revision can address many of these issues, further critical discussion is needed on the use of standardized questions to assess the same domains across contexts. [ABSTRACT FROM AUTHOR]

Summary: Background: Psychosocial concerns represent important outcomes in studies of treatments for acne and acne scarring. Also important, but largely overlooked, is the concept of appearance. Objectives: To design an acne‐specific patient‐reported outcome measure for acne and acne scarring. Methods: We used a mixed‐methods approach. Phase I involved 21 patient interviews that were audio‐recorded, transcribed and coded. Concepts were identified and developed into scales that were refined through 10 cognitive interviews and input from 16 clinical experts. Phase II involved data collection at hospital and community‐based dermatology clinics in Canada and the U.S.A. Eligible participants were aged 12 years and older with acne and/or acne scars on the face, chest and/or back. Rasch Measurement Theory (RMT) analyses were performed to examine psychometric properties. Results: Phase I led to the development of seven scales that measure appearance of facial skin, acne (face, chest and back) and acne scars, acne‐specific symptoms and appearance‐related distress. In phase II, 256 patients completed the ACNE‐Q. RMT analysis provided evidence that the items of each scale worked together conceptually and statistically. Most participants scored within the range of measurement for each scale (81·9–93·1%). Reliability was high, with person separation index values and Cronbach alpha values > 0·90 for the appearance scales, ≥ 0·87 for appearance‐related distress and ≥ 0·75 for symptoms. Worse scores on appearance scales correlated with worse symptom scores and more appearance‐related distress. Conclusions: The ACNE‐Q is a rigorously developed instrument that can be used to measure appearance and other patient‐centred concerns. What's already known about this topic? Acne is a common dermatological condition that can have an important impact on psychosocial function.Current patient‐reported outcome measures specific to acne focus mostly on measuring psychological and social impact. What does this study add? The ACNE‐Q provides a set of independently functioning scales that measure appearance of facial, back and chest acne, acne scarring and facial skin.Additional scales measure appearance‐related distress and acne symptoms. What are the clinical implications of this work? ACNE‐Q provides the dermatology community with a rigorously developed patient‐reported measure for acne that can be applied in clinical trials, research and patient care.The measurement of appearance by ACNE‐Q scales is more comprehensive than in other instruments providing important information on appearance of their acne and/or acne scars from the patient perspective. Respond to this article Linked Comment: Gabes. Br J Dermatol 2019; 181:1121–1122. Plain language summary available online [ABSTRACT FROM AUTHOR]

Introduction: Emerging tobacco products have become increasingly popular, and the US Food and Drug Administration extended its authority to all products meeting the definition of a tobacco product in 2016. These changes may lead to shifts in public perceptions about tobacco products and regulation, and national surveys are attempting to assess these perceptions at the population level. This article describes the item development and cognitive interviewing of the tobacco product and regulation perception items included in two tobacco-focused cycles of the Health Information National Trends Survey (HINTS-FDA), referred to as HINTS-FDA.Methods: Cognitive interviewing was used to investigate how respondents comprehended and responded to tobacco product and regulation perception items. Adult participants (n = 20) were selected purposively to oversample current tobacco users and were interviewed in two iterative rounds. Weighted descriptive statistics from the fielded HINTS-FDA surveys (N = 5474) were also calculated.Results: Items were generally interpreted as intended, and participants meaningfully discriminated between tobacco products when assessing addiction perceptions. Response selection issues involved inconsistent reporting among participants with little knowledge or ambivalent opinions about either government regulation or tobacco products and ingredients, which resolved when a "don't know" response option was included in the survey. The fielded survey found that a non-negligible proportion of the population do not have clear perceptions of emerging tobacco products or government regulation.Conclusions: A "don't know" response option is helpful for items assessing many emerging tobacco products but presents several analytic challenges that should be carefully considered. Multiple items assessing specific tobacco product and regulation perception items are warranted in future surveys.Implications: The findings from this study can serve as a foundation for future surveys that assess constructs related to emerging tobacco products, harm perceptions across multiple tobacco products, and tobacco-related government regulatory activities. The data provide unique insight into item-specific motivation for selecting a "don't know" response option for tobacco survey items. [ABSTRACT FROM AUTHOR]

This paper tests two hypotheses about how well five different methods—the Question Understanding AID (QUAID), the Survey Quality Predictor (SQP), expert review, the Questionnaire Appraisal System (QAS), and cognitive interviews—predict problems (as measured by missing data, behavior codes, and response latency) that occur in typical survey conditions. We find partial support for both the complementary methods hypothesis (using the evaluations methods together will yield the best prediction of problems) and the test environment hypothesis (the more directly the evaluation method observes the response process, the better it will predict problems). In addition, we find evidence that the methods perform somewhat differently for items measuring subjective as opposed to objective characteristics. [ABSTRACT FROM AUTHOR]

The only PRO validated for men after RP is Extended Prostate Cancer Index (EPIC). However, EPIC has weaknesses, including the lack of assessment of function in response to ED medication use, inclusion of ejaculation and absence of penile morphology assessment. We developed the RPQ to address these weaknesses. RPQ is a 41-item scale assessing 5 domains: erectile function (EF), sexual desire (SD), orgasm (O), sexual satisfaction (SS), and penile morphology (PM). The EF domain assesses erections in response to no medication, PDE5i, intracavernosal injections (ICI). We used a multi-step process to develop the RPQ including: extensive literature review; development of primary domains; item generation and winnowing; feedback from 8 sexual medicine experts; and cognitive interviewing with 10 patients to verify content, wording, and response format. For validation, post-RP men completed the RPQ and the following PROs: IIEF, EPIC, SEAR, and the PROMISE measures. Participants completed the RPQ again within two weeks. Analyses include internal consistency (Cronbach's alpha), test-retest reliability, and convergent/discriminant validity. Cronbach's alpha and test-retest reliability ≥0.7 were considered acceptable. Mean age of the 311 men was 62±7. All domains of the RPQ demonstrated strong internal consistency (Cronbach's alpha=0.70-0.98) and test-retest reliability (ICC= 0.82-0.99). There was sound convergent validity for the RPQ EF domains with/without medication demonstrate by correlations with the IIEF Erectile Function Domain (EFD) (r=0.31 to 0.70, p<.05). Discriminate validity was demonstrated for RPQ EF domains with/without medication with moderate correlations with the SEAR and PROMIS scales (r=0.23 to r=0.59, p<.01). There was also sound convergent validity for RPQ SD, O, and SS domains with strong correlations with the PROMIS desire, orgasm, and satisfaction scales (r=0.66 to r=0.77, p<.01), with discriminant validity demonstrating moderate correlations with SEAR Self-Esteem (r=0.38 to r=0.46, p<.01) and Sexual Bother (r=-0.43 to 0.66, p<.01). The RPQ PM domain demonstrated convergent validity with moderate correlations with the IIEF EFD and Orgasm domain (r=-0.20; r=0.33, p<.01, respectively) and discriminant validity with low, non-significant correlation with EPIC Urinary function. Initial validation of the RPQ supports the reliability and validity of the scale. Work supported by industry: no. [ABSTRACT FROM AUTHOR]

Introduction: Characteristics of electronic nicotine delivery systems (ENDS) make assessment of their use a challenge for researchers. Cognitive interviews are a way of gaining insight into participants' interpretations of survey questions and the methods they use in answering them, to improve survey tools.Methods: We used cognitive interviews to modify a young adult survey and improve assessment of quantity and frequency of ENDS use, as well as reasons for initiation and use of ENDS products. Twenty-five college students between the ages of 18 and 32 participated in individual cognitive interviews, which assessed question comprehension, answer estimation, retrieval processes, and answer response processes.Results: Comprehension issues arose discerning between ENDS device types (eg, cigalikes vs. vape pens), and answer estimation issues arose regarding ENDS use as drug delivery systems. These issues appeared to improve when pictures were added specifying the device in question, as well as when specific language naming nicotine as the ENDS product content was added to survey questions. Regarding answer retrieval, this sample of users had problems reporting their frequency of ENDS use, as well as quantifying the amount of ENDS products consumed (eg, volume of e-juice, number of cartridges, nicotine concentration).Conclusions: Accurate assessment of ENDS products proved challenging, but cognitive interviews provided valuable insight into survey interpretation that was otherwise inaccessible to researchers. Future research that explores how to assess the wide array of ENDS devices, as well as possible population differences among specific device-type users would be valuable to public health researchers and professionals.Implications: This study extends the current literature by using cognitive interviews to test ENDS assessment questions in a sample of young adults, a population at elevated risk for ENDS use. Problems encountered when answering ENDS use questions underscore the need to develop easily understood ENDS questions that allow for quantification of ENDS use. Future research examining the nature of ENDS product types and different levels of user experience will yield valuable assessment tools for researchers and tobacco control professionals. [ABSTRACT FROM AUTHOR]

This research, inspired by the cognitive interviewing literature, investigates misreporting of intimate partner violence when survey participants interpret items in unintended ways. In over 23 per cent of victimizations reported by university-aged males and in over 12 per cent of victimizations reported by females, follow-up questions revealed that purported violence was either accidental or done in a manner where neither partner took the event seriously. The problem was worse for perpetration reports where over 47 per cent of male reports and over 17 per cent of female reports were endorsed in a manner unintended by instrument design. The magnitude of the problem, together with its gendered nature, suggests that misreporting of this type is a substantial problem having the potential to negatively affect the testing of partner-violence theories. [ABSTRACT FROM AUTHOR]

Objective. Cross-cultural translation of patient-reported outcome measures (PROMs) is a lengthy process, often performed professionally. Cognitive interviewing assesses patient comprehension of PROMs. The objective was to evaluate the usefulness of cognitive interviewing to assess translations and compare professional (full) with non-professional (simplified) translation processes. Methods. A full protocol used for the Bristol RA Fatigue Multi-dimensional Questionnaire and Numerical Rating Scale (BRAF-MDQ, BRAF-NRS) was compared with a simplified protocol used for the RA Impact of Disease scale (RAID). RA patients in the UK, France, the Netherlands, Germany, Spain and Sweden completed the PROMs during cognitive interviewing (BRAFs in the UK were omitted as these were performed during development). Transcripts were deductively analysed for understanding, information retrieval, judgement and response options. Usefulness of cognitive interviewing was assessed by the nature of problems identified, and translation processes by percentage of consistently problematic items (≥40% patients per country with similar concerns). Results. Sixty patients participated (72% women). For the BRAFs (full protocol) one problematic item was identified (of 23 items x 5 languages, 1/115 = 0.9%). For the RAID (simplified protocol) two problematic items were identified (of 7 items x 6 languages, 2/42 = 4.8%), of which one was revised (Dutch). Coping questions were problematic in both PROMs. Conclusion. Conceptual and cultural challenges though rare were important, as identified by formal evaluation, demonstrating that cognitive interviewing is crucial in PROM translations. Proportionately fewer problematic items were found for the full than for the simplified translation procedure, suggesting that while both are acceptable, professional PROM translation might be preferable. Coping may be a particularly challenging notion cross-culturally. [ABSTRACT FROM AUTHOR]

There has been a recurrent recognition in inquiry reports following high-profile deaths of children known to welfare services of shortcomings in social workers' analytical and assessment skills. There is an urgent need to explore what might help supervisors and practitioners 'think about their thinking'. This paper draws on cognitive interviewing (CI) and examines its applicability/transferability to the professional domain of child-care social work supervision. Focusing on how practitioners make sense of their practice, this approach homes in on cognitive understandings but, in so doing, heightens practitioners' awareness of the emotional and affective dimensions of practice and of their thinking. The integration of cognitive and affective ways of knowing resonates with psycho-socially informed ideas about the interrelationship between thinking and feeling and the importance of emotional containment for effective thinking. This paper suggests that combining the psychological underpinnings of CI with psycho-socially informed concepts, such as containment, creates a more robust and holistic theoretical framework for supporting the application of CI in practice. The paper proposes that the adoption of a cognitive and affective approach to supervisory practice has considerable potential for enhancing practitioners' critical thinking skills and decision-making capabilities, to the benefit of the children and families with whom they work. [ABSTRACT FROM AUTHOR]

Cross-cultural cognitive interviewing (CCCI) has increasingly been practiced across a range of cultures, languages, and countries, in an effort to establish cross-cultural equivalence of survey questions and other materials, to detect sources of difficulties in answering survey questions for particular subgroups, and to detect problems related to translation from source to target languages. Although descriptions of such studies have proliferated in both the published and unpublished literatures, there has been little effort to reconcile discrepant views, approaches, and findings. The current synthesis reviews 32 CCCI studies located in peer-reviewed journals and books, along with key unpublished sources, to characterize these investigations in terms of their purpose, procedures, and findings. Based on a number of trends in this emergent field, conclusions are made concerning appropriate methods for cognitive testing of cross-cultural instruments, and recommendations are made for future practices that will serve to advance the CCCI field. [ABSTRACT FROM AUTHOR]

Introduction The transition from early childhood to teen years (5–12) is a critical time of development, which can be made particularly challenging by a burn injury. Currently, few validated standardized measures exist for this age group. This study aimed to generate item pools to create a computer adaptive test (CAT) assessing post-burn recovery in school-aged children. Methods Item pool development was based on the School-Aged Life Impact Burn Recovery Evaluation (SA-LIBRE5-12) Conceptual Model and the World Health Organization's International Classification of Functioning, Disability, and Health for Children and Youth. Additional elements included a literature review, expert consensus meetings, and parent cognitive interviews. Candidate items assessing health outcomes were extracted from existing legacy measures during the literature review. Details of expert consensus meetings and parent cognitive interviews are in Table 1. Results Items assessing health outcomes (n=3,732) were extracted during the literature review. Experts binned items across three domains: 1) Physical Functioning (55 items), 2) Psychological Functioning (80 items), and 3) Family and Social Functioning (57 items). Six cognitive interviews were conducted. Qualitative data resulted in further review of 86 items. The results of the cognitive interviews indicated that item stems and response choices were interpretable by respondents. Conclusions This study developed an item pool (n=192) to assess post-burn recovery of school-aged children. The next step in the SA-LIBRE5-12 CAT Profile development will be field-testing for the calibration and item response theory-based validation of the assessment. [ABSTRACT FROM AUTHOR]

Every cognitive interview pretest designer must decide how many interviews need to be conducted. With little theory or empirical research to guide the choice of sample size, practitioners generally rely on the examples of other studies and their own experience or preferences. We investigated pretest sample size both theoretically and empirically. Using a model of the relationship of sample size to question problem prevalence, detection power of the cognitive interview technique, and probability of observing a problem, we computed the sample size necessary, under varying conditions, to detect problems. Under a range of plausible values for the model parameters, we found that additional problems continued to be detected as sample size increased. We also report on an empirical study that simulated the number of problems detected at different sample sizes. Multiple outcome measures showed a strong positive relationship between sample size and problem detection; serious problems that were not detected in small samples were consistently observed in larger samples. We discuss the implications of these findings for practice and for additional research. [ABSTRACT FROM PUBLISHER]

Purpose: Emphasis on consumer-centered care for frail and institutionalized older adults has increased the development and adaptation of surveys for this population. Conventional methods used to pretest survey items fail to investigate underlying sources of measurement error. However, the use of the cognitive interview (Cl), a method for studying how respondents answer survey items, is not well established or documented in this population. This study demonstrates how CIs can be used to improve questionnaires intended for nursing home residents. Design and Methods: CIs were conducted with 29 nursing home residents in order to identify potential problems with prospective survey items. We used scripted probes to standardize the interviews and adapted the Question Appraisal System to enumerate and classify the problems discovered. Results: We fielded between one and five versions of each item in an iterative process that identified 61 item-specific problems. Additionally, residents' cognitive responses suggested that some screened their answers on the basis of perceived physical and environmental limitations, and some had difficulty answering items about preferences that fluctuate day to day. These findings led us to modify the items and response set to simplify the respondents' cognitive task. Implications: This study illustrates how Cl techniques can be used to understand residents' comprehension of and response to survey items. [ABSTRACT FROM AUTHOR]

This article presents information on the methods for testing and evaluating survey questions. In recent decades a growing awareness of conventional pretesting's draw backs has led to two interrelated changes. First, there has been a subtle shift in the goals of testing, from an exclusive focus on identifying and fixing overt problems experienced by interviewers and respondents to a broader concern for improving data quality so that measurements meet a survey's objectives. Second, new testing methods have been developed or adapted from other uses. These methods include cognitive interviews, behavior coding, response latency, vignette analysis, formal respondent debriefings, experiments and statistical modeling. The development of these methods raises issues of how they might best be used in combination, as well as whether they in fact lead to improvements in survey measurement. In addition, the adoption of computerized modes of administration poses special challenges for pretesting, as do surveys of special populations, such as children, establishments and those requiring questionnaires in more than one language all of which have greatly increased in recent years.

Background The Māori & Pasifika population experience high rates of health inequity, with a greater prevalence of obesity and the associated, life diminishing comorbidities. This is in part attributable to higher socioeconomic disadvantage, low health literacy and a lack of culturally tailored health services. Currently no validated tool exists to assess health behaviour change among Māori & Pasifika populations or success of tailored health interventions to tackle chronic disease. Methods The project incorporates a comprehensive validation and pilot testing process, including 1) cognitive interviewing and 2) test-retest reproducibility. Participants will include a representative sample of Māori & Pasifika young people and their parents/guardians. All research methodology is guided by cultural experts, specific to the Māori & Pasifika population. Results Qualitative data collected via cognitive interviewing will provide feedback regarding the readability, comprehension and content validity of the questionnaire items. Thematic analysis will inform improvements, optimising participant understandability. Cronbach's alpha will be used to assess internal consistency and Pearson's r will determine questionnaire test-retest reproducibility. Conclusions A validated questionnaire articulating with cultural values will provide meaningful data to researchers, health practitioners and government bodies regarding the lifestyle decisions of Māori & Pasifika peoples. Enhanced monitoring will determine the success of health initiatives to improve health outcomes of a priority population, across Australia and internationally. Key messages Lifestyle programs aiming to improve health outcomes are increasingly adapted to incorporate and acknowledge cultural values. Reliable measurement tools, including questionnaires, are fundamental to advancing future health research and tackling health inequity among priority populations. [ABSTRACT FROM AUTHOR]

Background The World Mental Health-Composite International Diagnostic Interview (CIDI) 3.0, originally in English, is a fully-structured interview designed for the assessment of mental disorders. Although Arabic translations of CIDI from countries like Lebanon and Iraq exist, a Modern Standard Arabic translation was developed to suit the Saudi population. While the translation model used in the present paper has been used to translate instruments in Asian and European languages, there is no study to the best of our knowledge which has used this specific model to translate a validated instrument from English to Arabic. Case presentation This paper describes the Saudi adaptation of CIDI 3.0. The TRAPD team translation model—comprising of translation, review, adjudication, pretesting and documentation—was implemented to carry out the Saudi adaptation of CIDI 3.0. Pretests involving cognitive interviewing and pilot study led to translation revisions which consequently confirmed that Saudi respondents had a good understanding of various items of the instrument. The adaptation procedures for the Saudi CIDI 3.0 were well documented and the instrument was linguistically validated with the Saudi population. Conclusions The TRAPD model was successfully implemented to adapt the CIDI 3.0 to be used as the main survey instrument for the Saudi National Mental Health Survey, findings of which will provide health policy makers mental health indicators for health decision making and planning. Key messages The CIDI 3.0 is a resourceful tool for examining mental health issues in the GCC. [ABSTRACT FROM AUTHOR]

This research explores the potential utility of response latency as an index of question problems in survey research. The time respondents took to answer three types of bad questions was compared to the time they took to answer the repaired versions of the questions. Questions containing a superfluous negative and double-barreled questions took longer to answer than nearly identical questions without these problems. Repaired versions of questions soliciting frequency estimates, however, took longer to answer than their problematic counter-parts. The results are discussed in the context of a model of question answering, and their implications for survey methodology are explored. [ABSTRACT FROM AUTHOR]