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Purpose: For patients with celiac disease (CeD), the only current management option is adherence to a strict gluten-free diet (GFD); however, many patients on a GFD continue to experience symptoms with a significant impact on quality of life. Potential new treatments for CeD are under development and a validated patient-reported outcome measure is required to evaluate their utility in clinical trials. The purpose of this article is to provide a history of the development of the Celiac Disease Symptom Diary (CDSD) 2.1© for use in clinical trials. Methods: Qualitative and quantitative studies were conducted from 2010 to 2021, including concept elicitation and cognitive debriefing interviews with adult and adolescent participants with CeD (N = 93) diagnosed via biopsy and/or serology and input from eight interviews with CeD clinical experts. During these studies, different iterations of the CDSD were presented to the US Food and Drug Administration and the European Medicines Agency, and modifications were made in line with their feedback. Results: These studies ultimately led to the development of CDSD 2.1©, a daily diary which focuses on key symptoms of CeD (abdominal pain, bloating, diarrhea, nausea and tiredness). This patient-reported outcome measure was readily understood by adult and adolescent participants with CeD and content validity was demonstrated in both populations. Conclusion: CDSD 2.1© is a content-valid patient-reported outcome measure developed in accordance with best practices and regulatory guidance. A thorough exploration of the psychometric properties of CDSD 2.1© for both adult and adolescent participants with CeD is ongoing to support utilization in clinical trials. [ABSTRACT FROM AUTHOR]

This paper investigates the disparities in adopting cognitive interviewing techniques between local and federal law enforcement agencies in the USA. Despite the established benefits of these techniques for enhancing witness recall accuracy and reducing false confessions, adoption at the local level lags significantly behind federal practices. Through a qualitative synthesis of existing literature and public reports, this study identifies the main barriers to adoption, which include resource limitations, training deficiencies, and cultural resistance within local agencies. The analysis suggests that comprehensive training programs, legislative mandates, and cultural shifts within law enforcement are critical to overcoming these barriers. Recommendations for promoting broader adoption include enhancing resource allocation for training, implementing national standards for investigative practices, and leveraging successful models from federal agencies. The paper underscores the need for a unified approach to improve investigative outcomes and justice across all levels of law enforcement. [ABSTRACT FROM AUTHOR]

Simple and easy to use kits for SARS-Cov-2 self-testing during epidemic waves are needed to optimize diagnostic capacity in low- and middle-income countries. SARS-Cov-2 self-testing kits are available, but application of these novel diagnostic technologies is less understood in low and middle-income contexts. We investigated the ability to understand and perform instructions for use (IFUs) for STANDARD Q COVID-19 Ag Test (SD Biosensor) and Panbio COVID-19 Ag Rapid Test Device (Abbott Rapid Diagnostics) for anterior nares (AN) nasal self-sampling and self-testing for COVID-19 in rural and urban Malawi. Qualitative research methods using iterative cognitive interview approach was used to investigate the ability of healthcare providers and lay community members to understand and perform a COVID-19 self-sample or self-test using the manufacturer's instructions for use. A total of 120 iterative cognitive interviews were done with healthcare providers and lay community members for self-sampling (N = 76) and self-testing (N = 44). Cognitive interviews began with the manufacturers version of instructions for use followed by subsequent iterations to refine problematic instructions. Structured interview guide and an observation checklist were used to collect data which was then coded inductively. A framework analysis approach was used to synthesize qualitative data. Study participants were generally proficient at performing a COVID-19 self-sampling and self-testing using the two COVID-19 Rapid Testing Devices. Several of design and content problems within manufacturer's instructions for use made their contextual application sub-optimal. Overall, participants experienced difficulties because of the omission of essential elements within instructions, use of short texts/phrase or lack of a word instruction, the lack of labels on where to open the package; the inconsistencies between word instructions within the instructions for use and the physical contents of the test package; the inability to digest and apply certain technical concepts and the lack of clarity in the phrasing of some text instructions. As expected, healthcare providers experienced fewer problems compared to lay community members. The refinement of these instructions greatly improved comprehension among lay community members. Self-sampling and self-testing for COVID-19 can be performed lay community members with fidelity in a scaled context if the manufacturer's instructions for use have been refined and tailored to the context. In the current study, we have used the study findings to map the optimisation process of manufacturer's IFU'S for self-testing RDT's intended for low literacy contexts including Malawi. [ABSTRACT FROM AUTHOR]

Background: Shared decision making in healthcare is a fundamental right for patients. Healthcare professionals' perception of their own abilities to enable shared decision making is crucial for implementing shared decision making within service. IcanSDM (I can shared decision making) is a brief measure to investigate healthcare professionals' perception of shared decision making approaches to their practices. It was developed in Canada with French and English versions, and recently translated into German. This study aims to adapt the IcanSDM measure for Danish-speaking healthcare professionals, and evaluate its psychometric properties. Methods: Cultural adaptation and translation based on Beaton et al.'s approach was applied. A forward translation by ten people and a backward translation by two people were performed. To assess comprehensibility, cognitive interviews were conducted with 24 healthcare professionals. Eighty healthcare professionals who were trained in shared decision making for either one hour (n = 65) or one day (n = 15) participated in the psychometric evaluation. The evaluation concerned acceptance, item characteristics, skewness, item difficulties, corrected item-total correlations, inter-item correlations, factorial structure, internal consistency, and responsiveness. Results: The forward and backward translation revealed few discrepancies, and participants understood the items well. The psychometric evaluation showed a high completion rate and acceptable item difficulties and discrimination values. Both the factor analysis and the internal consistency showed a 2-factor structure: 1) healthcare professionals' capacity to implement shared decision making; and 2) healthcare professionals' capacity to practise shared decision making. The IcanSDM_Danish obtained a Cronbach's alpha coefficient of 0.74. The evaluation of responsiveness showed improvement, but was not statistically significant. Conclusion: The IcanSDM_Danish has good cross-cultural validity and internal consistency, and a 2-factor structure. The IcanSDM_Danish is capable of providing reliable and valid measurement when evaluating constructed knowledge about shared decision making, and may be able to support the implementation of shared decision making training and evaluation of its impact. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusion The aim of this study was to develop an outcome measure for caregivers of children with food allergy.A community‐informed measure development process was utilised to generate a novel parent‐reported outcome tool for caregivers of children with food allergy. We conducted focus groups with parents and caregivers of food‐allergic (n = 18) children, following which a team of coders identified themes and generated an initial set of candidate items. These items were reviewed by content‐area experts (n = 10) using content validity indices. We then conducted a series of cognitive interviews with parents of children with food allergy (n = 12) validating the instrument draft.We describe the results of these development steps as well as future steps to produce the final, validated form of the measure. The resultant 91‐item measure is intended for parents of children ages two to 12 years.This measure fills a unique need in the field by leveraging key stakeholders' perspectives to develop and subsequently validate a novel parent‐reported measure of parent and family food allergy impacts of children ages two to 12 years old. [ABSTRACT FROM AUTHOR]

Background and purpose Methods Results Conclusions Affective disturbances and cognitive impairment are common sequelae of intracerebral hemorrhage (ICH), yet predictive models for these outcomes remain limited, especially for spontaneous supratentorial ICH with small hematomas (<30 mL). The aim of this study was to investigate predictors of affective disturbances and cognitive impairment following small spontaneous supratentorial intracerebral hemorrhage.We retrospectively analyzed 1692 patients with spontaneous supratentorial ICH between January 2018 and December 2020 at the First Affiliated Hospital of Harbin Medical University. Of these, 1563 patients completed a median follow‐up of 3.5 years. Cognitive function was evaluated using the modified Telephone Interview for Cognitive Status, and affective disturbances using the Hamilton Depression Scale and the Hamilton Anxiety Scale. Restricted cubic spline analyses were employed to examine the relationships between predictors and outcomes.In this cohort, 58.5% had cognitive impairment, 52.8% reported depressive symptoms, and 39.4% exhibited anxiety symptoms. Logistic regression models using Boruta's algorithm demonstrated strong predictive capacity, with areas under the curve of 0.82 for cognitive impairment, 0.78 for depressive symptoms, and 0.73 for anxiety symptoms. Hematoma volume was significantly linked to depressive symptoms (odds ratio [OR] 1.56, 95% confidence interval [CI] 1.38–1.76) and inversely to cognitive impairment (OR 0.67, 95% CI 0.59–0.77). Uric acid levels displayed a nonlinear relationship with cognitive impairment (OR 0.70, 95% CI 0.61–0.81). Hospitalization days significantly raised the risk of both depressive (OR 1.16, 95% CI 1.03–1.30) and anxiety symptoms (OR 1.17, 95% CI 1.04–1.31).The logistic regression model, enhanced by Boruta's algorithm, provides a valuable tool for predicting affective disturbances and cognitive impairment after ICH. It facilitates early identification and improves risk assessment for these neuropsychiatric outcomes in patients with small hematomas. [ABSTRACT FROM AUTHOR]

Background: While Type 2 Diabetes Mellitus (T2DM) prevalence is increasing among younger individuals, few studies have examined how age at T2DM diagnosis relates to dementia risk in diabetic populations. We aimed to investigate the association between age at T2DM diagnosis and subsequent dementia risk, and to determine whether obesity moderates this relationship. Methods: We conducted a prospective cohort study using data from the Health and Retirement Study (2002–2016) matched with its 2003 Diabetes Mail-Out Survey. The study included 1,213 dementia-free adults aged ≥50 with diagnosed T2DM. Primary exposures were age at T2DM diagnosis (categorized as <50, 50–59, 60–69, and ≥70 years) and obesity status (BMI ≥30 kg/m2). The outcome was incident dementia, assessed using the Telephone Interview for Cognitive Status. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs), adjusting for sociodemographic factors, health behaviors, health status, and diabetes medication use. Results: Over a median follow-up of 10 (interquartile range, 6–14) years, 216 (17.8%) participants developed dementia. Compared to participants diagnosed with T2DM at age ≥70 years, those diagnosed at younger ages had increased dementia risk: HR 1.70 (95% CI, 1.03–2.80) for 60–69 years, 1.72 (95% CI, 1.06–2.79) for 50–59 years, and 1.90 (95% CI, 1.14–3.18) for <50 years. Obesity significantly moderated this relationship, with obese individuals diagnosed with T2DM before age 50 showing the highest dementia risk (HR 3.05; 95% CI 1.23–7.56) compared to non-obese individuals diagnosed at ≥50 years. Conclusions: Younger age at diagnosis of T2DM was significantly associated with a higher risk of dementia, particularly among individuals with obesity. Interventions specifically targeting obesity may be more effective in preventing dementia for adults with a younger onset of T2DM. [ABSTRACT FROM AUTHOR]

The primary aim of this study was to investigate the construct validity of a survey focussing on the use of technology and teaching techniques to promote religious moderation, employing exploratory factor analysis (EFA). A total of 116 educators, who teach character development courses, were recruited to participate in the study. The developed instrument is based on the Technology Pedagogical Content Knowledge (TPACK) framework and has been validated through expert and cognitive interviews with religious education lecturers. The study’s results demonstrate that participants were able to discern conceptual distinctions between TPACK domains. Four factors were identified: TPACK, Pedagogical Content Knowledge (PCK), Technological Knowledge (TK), and Pedagogical Knowledge (PK). TPACK encompasses both Technological Pedagogical Knowledge (TPK) and Technological Content Knowledge (TCK), while PCK includes Content Knowledge (CK). Additionally, Rasch statistical analysis was employed to determine that the instrument measures a single latent variable, namely religiously moderated TPACK, with high reliability based on the fit of the scale to the Rasch model. The statistical data from the EFA and Rasch analyses suggest that this survey can serve as a valuable tool for researchers and educators interested in exploring TPACK within the context of religious moderation. [ABSTRACT FROM AUTHOR]

Current feedback models advocate learner autonomy in seeking, processing, and responding to feedback so that medical students can become feedback-literate. Feedback literacy improves learners' motivation, engagement, and satisfaction, which in turn enhance their competencies. However, there is a lack of an objective method of measuring medical student feedback literacy in the empirical literature. Such an instrument is required to determine the level of feedback literacy amongst medical students and whether they would benefit from an intervention. Therefore, this research protocol addresses the methodology aimed at the development of a comprehensive instrument for medical student feedback literacy, which is divided into three phases, beginning with a systematic review. Available instruments in health profession education will be examined to create an interview protocol to define medical students' feedback literacy from the perspectives of medical students, educators, and patients. A thematic analysis will form the basis for item generation, which will subsequently undergo expert validation and cognitive interviews to establish content validity. Next, we will conduct a national survey to gather evidence of construct validity, internal consistency, hypothesis testing, and test-retest reliability. In the final phase, we will distribute the instrument to other countries in an international survey to assess its cross-cultural validity. This protocol will help develop an instrument that can assist educators in assessing student feedback literacy and evaluating their behavior in terms of managing feedback. Ultimately, educators can identify strengths, and improve communication with students, as well as feedback literacy and the feedback process. In conclusion, this study protocol outlined a systematic, evidence-based methodology to develop a medical student feedback literacy instrument. This study protocol will not only apply to medical and local cultural contexts, but it has the potential for application in other educational disciplines and cross-cultural studies. [ABSTRACT FROM AUTHOR]

Background and Objectives: This study aims to translate and culturally adapt the Toronto Extremity Salvage Score (TESS) for Latin American Spanish–speaking patients, enhancing the tool's accessibility for evaluating postsurgical functional outcomes in sarcoma patients across Latin America. Methods: The TESS questionnaires for lower extremity (LE) and upper extremity (UE) were translated and adapted following international guidelines. The process included forward and backward translation, expert committee review, and pretesting with cognitive interviewing. Patients treated for bone or soft tissue tumors in LE or UE were recruited to complete the adapted questionnaires. Test–retest reliability was evaluated by having participants complete the questionnaire again 2 weeks after the initial assessment. Results: A total of 89 participants completed the questionnaires. The study found high internal consistency, with Cronbach's alpha values reaching 0.9437 for LE and 0.9402 for UE. An agreement rate of 98.4% for the global score of TESS‐LE (95% confidence interval [CI]: 0.909–1.059) and 93.9% for TESS‐UE (95% CI: 0.882–0.995) was observed, demonstrating strong test–retest reliability. Conclusions: The Latin American Spanish version of TESS for both lower and upper extremities is a reliable and culturally appropriate tool for assessing physical function in limb sarcoma patients. Further validation across diverse Latin American populations is encouraged to strengthen its broad applicability. [ABSTRACT FROM AUTHOR]

ABSTRACT: Background: With young people and teenage children, India has recently become a hotspot for a multiple-fold increase in internet users. The objective of our study was planned to create a psychometric scale specially targeting school and college students with appropriate validation and cut-off derivation, as these groups are collective and also holds a major burden of internet addiction and also a potential risk group for developing internet addiction disorder. Methods: This was a cross-sectional study with a sample size of 1530 done among college students and school students studying between IX to XII standard with habit of internet usage. A google form survey questionnaire was used and study was conducted for a period of 2 months. Domain identified was Internet addiction which was followed by Item generation done by both Inductive, Deductive method and Content validity obtained from the field experts. After Cognitive Interviewing, survey was conducted by circulating the constructed scale in the Google form questionnaire to the eligible participants. After collecting the required data from the participants, the scale was subjected to Item Reduction Analysis. Results: The mean age of the study participants was 18.96 ±3.68 years and most of them were females. All the individual items had discrimination index value of higher than 0.75 and Cronbach's alpha of 0.75. The total weighed score calculated by adding the individual weighed score came as 21078. Correction factor obtained by dividing the weighed score to the raw score was 0.89. Using the Internet Addiction Scale for School and College Students (IASSCS) having a cut off value of 16 to delineate a person to have Internet addiction and No Internet addiction, around 63% of the study participants were found to have internet addiction and 37% of them were not having Internet addiction and among them a greater number of Internet addicts were found to be male compared to females. Conclusion: Due to the fact that internet addiction is linked to numerous physical and mental health problems, it may be more beneficial to use scale reports as screening tools at the primary health care level in order to identify high-risk groups for health problems caused by internet addiction at the earliest. [ABSTRACT FROM AUTHOR]

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]

Objective: To identify factors that influence response processes for patients providing quantitative self-report data. Secondly, due to the lack of integrative and explanatory models in this area, to develop a model of patients' response processes that can guide what to look for when considering validity evidence and interpreting scores on individual items. Methods: Participants (n = 13) were recruited from a specialized substance use disorder treatment clinic and interviewed while responding to items from a clinical feedback system implemented for routine outcome monitoring in that setting. The interview approach was based on cognitive interviewing. Data collection and analysis were inspired by a grounded theory approach. Results: We identified several variables that influenced the participants' response processes. The variables were organized into five categories: context-related variables; item-related variables; response base variables; reasoning strategies; and response selection strategies. We also found that the participants' responses for many items were affected by different aspects of the response process in ways that are relevant to interpretation but not necessarily discernible from the numerical scores alone, and we developed response categories to capture this. Conclusion: The findings suggest that patients providing quantitative self-report data encounter conditions in the response process that challenge and influence their ability to convey meaning and accuracy. This results in responses that for many of the items reflect messages important for interpretation and follow-up, even if it does not appear from the numerical scores alone. The proposed model may be a useful tool when developing items, assessing validity, and interpreting responses. [ABSTRACT FROM AUTHOR]

Rumination (self-referential and repetitive thinking), attentional biases (AB), and impaired cognitive control are theorized as being integral factors in depression and anxiety. Yet, research examining the relationship between rumination, mood, and AB for populations with reduced cognitive control, e.g., people living with dementia (PwD), is lacking. To explore whether literature-based relationships are demonstrated in dementia, PwD (n = 64) and healthy controls (HC) (n = 75) completed an online self-report survey measuring rumination and mood (twice), and a telephone cognitive status interview (once). Rumination was measured as an emotion-regulation style, thinking style, and response to depression. We examined the test-retest reliability of PwD's (n = 50) ruminative-scale responses, ruminative-scale internal consistency, and correlations between rumination, age, cognitive ability, and mood scores. Also, nine participants (PwD = 6, HC = 3) completed an AB measure via eye-tracking. Participants fixated on a cross, naturally viewed pairs of facial images conveying sad, angry, happy, and neutral emotions, and then fixated on a dot. Exploratory analyses of emotional-face dwell-times versus rumination and mood scores were conducted. Except for the HC group's reflective response to depression measure, rumination measures were reliable, and correlation strengths between rumination and mood scores (.29 to.79) were in line with literature for both groups. For the AB measure subgroup, ruminative thinking style scores and angry-face metrics were negatively correlated. The results of this study show that literature-based relationships between rumination, depression, and anxiety are demonstrated in dementia, but the relationship between rumination and AB requires further investigation. [ABSTRACT FROM AUTHOR]

Background and Aims: Falling is a serious threat for patient safety in hospitals. This study aimed to identify the risk factors of fall amongst rehabilitation patients and to use them for developing and validating the Persian version of Fall Risk Assessment Scale (FRAS). Methods: The current methodological study was conducted in two phases. In the first phase, based on the review of the literature and investigation of the medical records of 251 patients selected via purposive sampling, the risk factors of fall were extracted and the FRAS was developed accordingly. In the second phase, the face and content validities of the designed scale were determined by cognitive interview and Content Validity Index (CVI) and to evaluate the construct validity, known‐groups comparison was performed. Its inter‐rater reliability was analyzed using the weighted Kappa Coefficient (κ*). The study adhered to COSMIN guidelines. Results: Fall was significantly associated with disease diagnosis, used medications, history of fall, cognitive impairments, and three items of the Functional Independence Measure (toilet transfer, bed transfer, and shoer transfer). The CVI of the scale was 0.94. The risk for falls group had a significantly higher perceived fall risk than the no risk for falls group, thus establishing known‐group validity. Its weighted kappa coefficient was >0.85, its sensitivity was 73%, and its specificity was 82%. Conclusion: The valid and reliable FRAS may accurately assess the level of Fall Risk patients in Rehabilitation wards, helping to predict fall during hospitalization. So, enabling the planning and implementation of effective caring interventions. [ABSTRACT FROM AUTHOR]

Multiple-choice tests are widely used to measure learning outcomes. Consequently, constructing high-quality test items is critical, and many authors have advanced item-writing guidelines. One frequently mentioned guideline is to arrange the response options vertically. However, evidence to support this recommendation is scarce and has only been obtained for items with text-based options. This study aimed at understanding whether the arrangement of options affects performance at solving items with large-sized options, such as graphs and pictures, using objective and subjective measures. Fifty-seven high-school students completed a multiplechoice science and mathematics test with 24 four-choice items, options being graphs or pictures presented in one of four arrangements: vertical without page break, vertical with page break, Z, and inverted N. Response accuracy, response time, and perceived difficulty were obtained for each item. Subsequently, students participated in a cognitive interview about their experiences, practices, perceptions, and beliefs regarding the arrangement of options. Objective measures show that the arrangement of options hardly affected performance, the only effect being that vertical condition with page break resulted in significantly longer response times. Subjective measures show that most students favored the vertical arrangement they consider more common but negatively perceived vertical condition with page break and considered squared arrangements (Z, inverted N) to facilitate visual exploration and comparison between options, as opposed to the vertical arrangement. Results suggest that the vertical arrangement does not offer clear advantages over squared arrangements for items with large-sized options. [ABSTRACT FROM AUTHOR]

Background: Decision-making and problem-solving processes are powerful activities occurring daily across all healthcare settings. Their empowering potential is seldom fully exploited, and they may even be perceived as disempowering. We developed the EMPOWER-UP questionnaire to enable assessment of healthcare users' perception of empowerment across health conditions, healthcare settings, and healthcare providers' professional backgrounds. This article reports the initial development of EMPOWER-UP, including face and content validation. Methods: Four grounded theories explaining barriers and enablers to empowerment in relational decision-making and problem-solving were reviewed to generate a preliminary item pool, which was subsequently reduced using constant comparison. Preliminary items were evaluated for face and content validity using an expert panel of seven researchers and cognitive interviews in Danish and English with 29 adults diagnosed with diabetes, cancer, or schizophrenia. Results: A preliminary pool of 139 items was reduced to 46. Independent feedback from expert panel members resulted in further item reduction and modifications supporting content validity and strengthening the potential for generic use. Forty-one preliminary items were evaluated through 29 cognitive interviews, resulting in a 36-item draft questionnaire deemed to have good face and content validity and generic potential. Conclusions: Face and content validation using an expert panel and cognitive interviews resulted in a 36-item draft questionnaire with a potential for evaluating empowerment in user-provider interactions regardless of health conditions, healthcare settings, and healthcare providers' professional backgrounds. Plain Language Summary: Users of healthcare services living with long-term health conditions may need empowerment-based support from healthcare providers to discover and develop their inherent capacity to be responsible for their own life. This ensures that healthcare users develop the skills needed to manage the many decisions and problems they face. Yet many healthcare users still experience lack of involvement and support in decision-making and problem-solving. Therefore, we developed the EMPOWER-UP questionnaire to allow healthcare users to evaluate the empowering qualities of their interactions with healthcare providers regardless of their diagnosis, where the interactions take place, and with whom. The aim of this article was to describe the development of EMPOWER-UP and to present the results of early evaluations of its content. The questionnaire was developed in Danish based on thorough qualitative research explaining distinct, complex patterns in user-provider interactions and translated to English during the evaluation process. We used individual feedback from a panel of expert researchers and interviews conducted with healthcare users diagnosed with diabetes, cancer, or schizophrenia to evaluate EMPOWER-UP's content. Interviews were conducted while the participants answered preliminary versions of the questionnaire. As a result of these evaluations, several items in the questionnaire were adjusted, some were deleted, and some new items were developed. We believe that EMPOWER-UP can be an important tool to help evaluate the effectiveness of interventions aimed at ensuring empowering support from healthcare providers. Thus, EMPOWER-UP may help to identify the most effective interventions for specific healthcare contexts. [ABSTRACT FROM AUTHOR]

Background: Native Hawaiian and Pacific Islanders (NHPI) are disproportionately burdened by pregnancy-related deaths in the United States and have the lowest engagement in prenatal care compared to all other US racial groups. Aside from access barriers, studies suggest that NHPI face challenges with patient-clinician communication, perceived discrimination, and cultural conflicts within healthcare settings. This paper describes the cultural adaptation of the 14-item Mothers On Respect index for NHPI, originally developed by Vedam et al. (2017) for diverse communities in British Columbia, Canada, and reports the findings of the preliminary psychometric assessment of the adapted measure. Methods: Data from 26 interviews with NHPI women, expert, and cognitive interviews were conducted to inform the adaptation. An online survey was administered to a sample of 90 NHPI women to assess construct validity, convergent validity, and internal reliability of the adapted measure using exploratory and confirmatory factor analyses. Results: The adaptation resulted in substantial changes to the original measure, mainly by the addition of items related to 'feeling cared for by and connected to the provider' and 'perceived threats hindering communication.' The psychometric analyses identified a three-factor structure for the culturally adapted index and confirmatory factor analyses were employed to refine the measure. The result was a 25-item index with acceptable goodness of fit indices, high internal reliability (Cronbach's alpha of 0.96, 95% CI =.94-.97) and convergent validity with a related scale. Overall, participants in this sample indicated high levels of respectful care; however, people who received < 8 prenatal care visits had significantly lower ratings on average. Conclusions: Our findings suggest that the elements valued by NHPI are not fully captured in existing measures of respectful maternity care. Efforts to assess more discrete aspects of the patient-provider relationship for culturally distinct and racialized groups could help improve the quality of care and advance equity in maternal and perinatal health marginalized communities. [ABSTRACT FROM AUTHOR]

Introduction Methods Results Conclusions One of the most common assessment tools for examining the competencies of health professionals is the Objective Structured Clinical Examination (OSCE).In this study, an Educational Effects of OSCE Questionnaire (EEOQ) was developed and validated in seven steps: (1) Reviewing the literature, (2) Holding focus groups, (3) Synthesizing the results of literature review and focus groups, (4) Developing items, (5) Evaluating content validity, (6) Conducting cognitive interviews, and (7) Implementing a pilot test.The analysis of the literature review and focus groups revealed that the educational effects of OSCE are influenced by factors related to the test, the examiner, the peers, and the student. Initially, 22 items were developed, but one item was excluded based on the results of the I‐CVR and I‐CVI indices. In the Exploratory Factor Analysis, the KMO index was computed to be 0.85, and the significance of Bartlett's test of sphericity was confirmed (p < 0.001). The Total Variance Explained table showed that the educational effects of OSCE were grouped into four factors: content, structure, reflection and review, and feedback along with OSCE.This study found good evidence of validity and reliability for a questionnaire measuring the educational effects of OSCEs. It was discovered that OSCE can have different effects on student learning processes. [ABSTRACT FROM AUTHOR]

Background: Individuals exhibit varying degrees of flexibility depending on different characteristics, conditions, and diagnoses. The Flexibility Scale is a comprehensive informant-report measure used to assess multiple aspects of flexibility in autistic and non-autistic children and youth, with an emphasis on cognitive aspects. This tool has not been adapted nor validated for use in Spain. Methods: In this paper we aim to provide a culturally adapted and validated version of the Flexibility Scale for Spain. We detail the procedure followed by our research team to obtain a cultural adaptation of the scale for Spain, including forward and back translations, cognitive interviews, feedback from experts, and preliminary validation. Our participants in the validation process were 75 autistic and 39 typically developing children and adolescents between the ages of 6 and 17. Results: We reached a culturally adapted and preliminary validated version of the Flexibility Scale for Spain (Escala de Flexibilidad). Conclusions: We make the scale available to researchers and practitioners working in Spain. This contributes to laying the groundwork for further testing and adaptations in Spanish-speaking countries and communities worldwide. [ABSTRACT FROM AUTHOR]

The KATITA-25 (Kidney AlloTransplant Immunosuppressive Therapy Adherence) Questionnaire is a multidimensional self-administered scale developed in Brazilian Portuguese that measures the predisposition for non-adherence to immunosuppressive medication in candidate patients for kidney transplantation, in the pre-transplant setting. The aim of this study was the cross-cultural validation of the Spanish version of the KATITA-25 scale. The translation/back-translation method was used, followed by cognitive interviews and a pre-test. The Spanish version of KATITA-25 was administered to 163 candidate patients for kidney transplantation from 2 kidney transplant centres and 2 dialysis centres in Catalonia, Spain. The scale was re-administered to the first 79 patients included into the study, after a 2 to 4 weeks interval. Internal consistency was assessed using Cronbach's alpha, test–retest reliability with the intraclass correlation coefficient (ICC); construct validity with goodness of fit indices after confirmatory factor analysis using structural equation modelling. The Cronbach's alpha of the Spanish version was 0.83, the ICC was 0.86. Confirmatory factor analysis showed adequate fit of the structural model. Overall, the analytical results closely resembled those obtained in the validation of the original scale. In conclusion, this cross-cultural validation study showed adequate reliability and construct validity of the Spanish version of the KATITA-25 questionnaire. [ABSTRACT FROM AUTHOR]

Algorithms play a significant role in shaping our experiences of interacting with intelligent information systems but also inherit and amplify data biases, potentially leading to unfair decisions or discriminatory outcomes. This motivates us to investigate users' algorithm literacy, which covers the awareness and knowledge of algorithms and the skills to intervene in the operations of personalization algorithms when interacting with recommendation systems. Since vulnerable groups are more likely to suffer from the negative consequences of algorithmic decision‐making, investigating algorithm literacy among such groups is critical. This study aims to examine older adults' algorithm literacy, who are often considered a vulnerable group and labeled as digital laggards in contemporary information society. The empirical evidence collected from 21 participants in in‐depth interviews and cognitive mapping studies demonstrated that almost all participants are algorithm‐aware to some extent and identified (1) three types of information and sources collected by algorithms in user understanding, (2) two paradigms of how respondents understand personalized recommendations, and (3) two sets of strategies they develop to employ algorithms for improving user experience. The findings shed light on designing human‐centered intelligent information systems for unbiased personalization and developing a more inclusive AI‐assisted society that equally benefits people of all ages. [ABSTRACT FROM AUTHOR]

Early intervention improves the developmental progress among toddlers with ASD. Family involvement enhances the intervention outcome. This study aimed to develop and test the feasibility of an early intervention home program manual for toddlers with ASD. Method: This study involved three phases: (I) formulation of manual concept and content design (II) manual development through focus group discussion (n = 10) and content validation by experts (n = 9); (III) cognitive interview (n = 6) and feasibility study (n = 8). Result: Content Validity Index (I-CVI) for the developed manual ranged from.78–1.0, S-CVI/Ave.96, and S-CVI/UA.79. Cognitive interview among six parents reported that the manual was easy to understand. The feasibility study reported all eight parents benefitted from coaching sessions. Approximately 87.5% of the respondents found the program benefited their children and could easily implement the activities in their daily routines. Approximately 75% of respondents reported having greater confidence in managing their child's behaviors at home. Parent coaching using the developed home program is feasible and accepted by parents of a toddler with ASD. Further study should be developed to explore the effectiveness of parent coaching using the manual. [ABSTRACT FROM AUTHOR]

Background: Identification of exposures in patients with interstitial lung diseases (ILDs) is essential for diagnosis and management and can be facilitated through the use of exposure questionnaires. However, for most ILDs, a patient-focused questionnaire is lacking. Cognitive interviewing is a methodology used to evaluate sources of understanding and misunderstanding in a questionnaire and to provide evidence of content validity. We developed and refined a new exposure questionnaire for patients with fibrotic ILDs by using cognitive interviewing to establish its understandability and content validity. Methods: An exposure assessment questionnaire was developed by a multidisciplinary team. Cognitive interviews with 24 patients with fibrosing ILDs were conducted by trained interviewers over the phone or Zoom using a semi-structured interview guide. The questionnaire was amended based on the interviewers' interpretation of sources of misunderstanding. The revised questionnaire was tested in a second round of cognitive interviews with a different group of 24 patients. Results: Among the 48 patients who completed interviews, mean age was 61 years, 58.3% were male and 75.0% were white. Based on the first round of cognitive interviews, the multidisciplinary team modified the questions, organization, and instructions of the questionnaire to facilitate recall, adjust for exposures that were frequently misunderstood or required clarification, and focus on clinically relevant exposures. The revised questionnaire performed well in the second round of interviews. Conclusion: An exposure questionnaire, developed with input from patients, can be used to assess clinically relevant exposures in adults with fibrosing ILDs. This is the first questionnaire for all types of fibrosing ILD to have undergone content validation. [ABSTRACT FROM AUTHOR]

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

This article illustrates and differentiates the unique role cognitive interviews and think-aloud interviews play in developing and validating assessments. Specifically, we describe the use of (a) cognitive interviews to gather empirical evidence to support claims about the intended construct being measured and (b) think-aloud interviews to gather evidence about the problem-solving processes students use while completing tasks assessing the intended construct. We illustrate their use in the context of a classroom assessment of an early mathematics construct – numeric relational reasoning – for kindergarten through Grade 2 students. This assessment is intended to provide teachers with data to guide their instructional decisions. We conducted 64 cognitive interviews with 32 students to collect evidence about students' understanding of the construct. We conducted 106 think-aloud interviews with 14 students to understand how the prototypical items elicited the intended construct. The task-based interview results iteratively informed assessment development and contributed important sources of validity evidence. [ABSTRACT FROM AUTHOR]

The current study examined the Cognitive Interview (CI) for eliciting information about an overheard conversation (planning a future crime). Interviews were conducted either in‐person or via telephone. The CI elicited more information, and at a comparable accuracy level, in comparison to a structured interview (SI). The efficacy of the CI was not significantly influenced by whether the interview was conducted in‐person or via telephone. It took more time to conduct the CI than the SI. Finally, various measures of efficiency showed that the CI was as or more efficient than the SI. Suggestions are offered about adapting the CI for telephone interviews. [ABSTRACT FROM AUTHOR]

Obtaining accurate information from eyewitnesses is a crucial element in criminal investigations. Interview strategies such as the Cognitive Interview (CI) and the Self‐Administered Interview (SAI) have been developed and implemented to minimise inaccuracies and enhance the recall and reliability of eyewitness evidence. The SAI is a recent development within forensic psychology. However, a question remains as to the effectiveness of the SAI as an investigative interview tool. A systematic review of published studies employing the SAI was conducted (n = 22), and all were considered in relation to three variables (estimator, system and methodological). As the number of studies within the evidence base was relatively small, we could not ascertain whether the SAI is an effective investigative interviewing tool. However, the results demonstrate a number of positive benefits of the SAI. We discuss the implications of these findings for policy and directions for future research. [ABSTRACT FROM AUTHOR]

Purpose: Adherence to growth hormone treatment is known to affect growth outcomes. Both device preference and ease of use have been shown to affect treatment adherence. In this study, we assessed device preference and ease of use with two long-acting growth hormones, somapacitan (Sogroya®, Novo Nordisk A/S) and somatrogon (Ngenla®, Pfizer). Patients and Methods: In a randomized, crossover study conducted between September 20 and November 2, 2023, we recruited 33 adolescents with a growth-related disorder, and 37 caregivers, at six locations in the United States. Each participant was trained in the use of both devices and asked to perform a simulated injection. Device training time, preparation and injection time, and injection completeness were recorded. Participants also completed the Device Handling and Preference Questionnaire (DHPAQ) to indicate their device preference and ease of use opinions. Following conclusion of the "standard" visit, 10 adolescents and 10 caregivers were randomly selected to participate in a sub-study to validate the relevance, comprehensiveness, and comprehension of the DHPAQ. Results: The majority of participants (84.3%; 95% confidence interval [CI]: 74;92) preferred the somapacitan device to the somatrogon device (p <  0.0001). Almost all (98.6%; 95% CI: 92;100) participants answered that the somapacitan device was easy or very easy to use, while three-quarters (74.3%; 95% CI: 62;84) answered the same for the somatrogon device. Average training and injection times were lower for the somapacitan device than for the somatrogon device. Also, more patients successfully completed the injection with the somapacitan device than with the somatrogon device (97.1% vs 92.9%). Cognitive debriefing interviews indicated the DHPAQ was relevant, comprehensive, and fully comprehended. Conclusion: The somapacitan device was preferred to the somatrogon device by a majority of participants. More participants considered the somapacitan device to be easy or very easy to use than the somatrogon device. Plain Language Summary: • Children who grow slower in height than their peers often need growth hormone replacement treatment to reach normal height. This treatment involves daily or weekly injections for several years. Injecting treatment regularly is important for it to work properly, but the schedule can be difficult to adhere to. • From previous research, we know injection devices can influence adherence to treatment. Researchers in this study aimed to compare two different pen injectors (once-weekly medicines called somapacitan and somatrogon) to see which one patients and caregivers prefer and find easier to use. • This USA-based study included 33 adolescents with growth problems who injected themselves, and 37 caregivers of younger patients. During one visit, they were trained in how to use each device, observed giving a practice injection, and asked to fill in a questionnaire with their experience. Half of the participants did this with the somapacitan pen injector first and the somatrogon one second, while the other half followed the opposite order. • The researchers found that 84.3% of participants preferred the somapacitan pen‑injector, while 12.9% preferred the somatrogon pen-injector, and this difference was statistically significant. Almost all (98.6%) participants found the somapacitan pen‑injector easy or very easy to use, while three-quarters (74.3%) answered the same for somatrogon. On average, the participants learned to use the somapacitan device faster and more correctly than the somatrogon device. • In conclusion, given the device preference and ease of use, patients may be more likely to adhere to treatment with somapacitan compared with those receiving somatrogon. [ABSTRACT FROM AUTHOR]

Essentially unchanged measures of political interest have been included in every single survey on politics since the 60s, but recent research questions their validity. In addition, a context of increasing polarization around politics advices to re-examine what people have in mind when reporting political interest. To unpack what exactly the interest question is measuring, in this article we report the results of a mixed approach that combines qualitative and quantitative data. The first study consists of cognitive interviews to identify what comes to people's minds when asked about their political interest in surveys. The qualitative information is then used to inform an experiment embedded in a large N survey to tap into whether responses to survey questions about political interest are malleable to affective frames. Results show that the affective dimension seems to be particularly critical regarding answers to the political interest question but that the levels are marginally malleable to a negative frame. Overall, political interest appears to capture respondents' affective relation to politics and to do so consistently. [ABSTRACT FROM AUTHOR]

Background: Left ventricular assist device (LVAD) recipients report symptom improvement but find adjusting to life with the LVAD challenging. These challenges are unique, and existing patient‐reported outcome measures (PROMs) do not reflect their experiences. This study aimed to develop a culturally relevant quality of life PROM for use with LVAD recipients in future research, design evolutions and clinical practice. Methods: A three‐stage mixed‐methods approach was used to develop a PROM: stage 1 included group concept mapping (GCM); stage 2 semi‐structured qualitative interviews were conducted with 11 LVAD recipients and 10 clinicians, and a questionnaire was developed using a conceptual framework; and stage 3 used exploratory psychometric analysis of the PROM data using Rasch measurement theory. This paper presents stages 2 and 3. Results: The conceptual framework consisted of four key concepts, including general health, life with the LVAD, equipment and clothing and emotional impact. Statements from interviews and GCM were used to create items for the LVAD quality of life (LVAD‐QoL). Cognitive interviews tested face validity and participant comprehension. Forty‐nine participants were recruited from three UK transplant centres. PROM data were collected and analysed using Rasch analysis. Four items displayed misfit; dependency between item sets was the biggest issue (57/485 pairwise differences). After restructuring and dealing with item misfit, the LVAD‐QoL conformed to the Rasch model, supporting the psychometric properties and quality of the LVAD‐QoL. Conclusions: Using a mixed‐methods approach ensured the development of a robust and psychometrically sound tool for research, design evolution and clinical practice with LVAD recipients. [ABSTRACT FROM AUTHOR]

Abstract Background Sexual and reproductive empowerment (SRE) is an important determinant of women’s and girls’ health yet measuring it is complex due to cultural and domain-specific variations. This study describes the process of adapting an SRE scale consisting of four domains (self-efficacy; future orientation; social support; and safety) and testing its psychometric properties among Arabic speaking adolescent girls in Lebanon. Methods An SRE scale developed in a Western context was adapted in four steps: (1) reviewing the scale and selecting culturally appropriate domains for translation to standard Arabic; (2) conducting cognitive interviews with 30 11-17-year-old adolescent girls in Lebanon; (3) administering the scale to 339 refugee adolescent girls who participated in an early marriage intervention; and (4) conducting confirmatory factor analysis (CFA) on the data to assess the scale’s psychometric properties. Results The original model for the 13-item, four-domain adapted scale demonstrated poor fit in CFA. After iteratively removing two items, scale properties were improved, albeit were not optimal. The validity and reliability results for the self-efficacy domain were acceptable. Cognitive interview data revealed that Arab adolescent girls understood self-efficacy in relational terms, recognizing that autonomous decision-making is not necessarily favored but is influenced by parents and family. Conclusions This study presents an effort to customize an SRE scale for use in studies on the health of adolescent girls in an Arab cultural context. Findings from cognitive interviews highlight the importance of taking into consideration relationality in adolescent sexual and reproductive decision-making. The self-efficacy domain in the adapted scale demonstrates acceptable psychometric properties and is recommended for use in health studies to capture SRE.

The access to evidence-based treatments for mental health problems is limited in low-resource settings. Transdiagnostic approaches, such as the Unified Protocol (UP), are a potential solution for these settings because they are multi-problem focused, modular, flexible, and have low complexity. This study aimed to adapt UP to the mental health context of an urban speciality clinic in Pakistan using a four-step process of heuristic framework. The study employed an iterative and stakeholder-based approach to align the protocol with local values, language, and needs. Primarily, the proposed modifications focus on language use, matching literacy level, graphical illustrations, and relevance of examples. A multi-method approach including expert review, cognitive interviewing, and adaptation testing ensured cultural equivalence. Participants diagnosed with depression and anxiety were provided culturally adapted treatment (N = 15) at the testing phase. Findings indicated that the participants not only experienced significant reductions in symptoms of depression and anxiety but also found the culturally adapted UP to be easy to understand, culturally relevant, and engaging. This study provides evidence that the UP can be culturally adapted and used in the mental health context of Pakistan. The findings suggest that the UP is a promising intervention for individuals with depression and anxiety in low-resource settings. [ABSTRACT FROM AUTHOR]

Background: The EQ-5D-Y is a generic preference-weighted measure for children and adolescents which was developed within Europe. Two versions exist, the EQ-5D-Y-3L (Y-3L) and EQ-5D-Y-5L (Y-5L). This study aimed to cross-culturally adapt the Y-3L and Y-5L for use in Singapore and to assess the content validity, specifically, the relevance and comprehensiveness of the EQ-5D-Y descriptive system (DS) in Asia. Methods: To culturally adapt the instruments, an expert panel consisting of paediatricians and primary school educators were consulted. Modifications suggested by the expert panel were tested via cognitive debriefing interviews with children aged 8–12 in Singapore. To assess the content validity of the EQ-5D-Y DS, interviews were conducted with both healthy (n = 8) and ill children (n = 6) aged 8–15. In the interviews, children discussed their experience with poor health and commented on the comprehensiveness and relevance of the EQ-5D-Y DS. Results: The cross-cultural adaptation process led to minor modifications to the UK English Y-3L and Y-5L versions, including using phrases familiar to the local children and adding examples to facilitate understanding. The five health dimensions in the EQ-5D-Y DS were spontaneously elicited when children discussed their experience with poor health. All health dimensions related to poor health elicited from the interviews fell into three broad categories: physical health (e.g. Appetite, Mobility, and Sleep), mental well-being (e.g. Annoyed/Frustrated and Scared/Worried), and social relationships (e.g. Family and Friends). The EQ-5D-Y DS was generally found to be relevant and comprehensive, although some health dimensions that may be relevant to the local population (Social relationship and Appetite) were not covered. Conclusions: The UK English EQ-5D-Y instruments were adapted to produce the Singapore English EQ-5D-Y instrument that were comprehensible to local children as young as 8 years old. The EQ-5D-Y DS was generally relevant and comprehensive to measure poor health of local children. Future studies should ascertain the benefits of adding bolt-on items related to social relationships and appetite to the EQ-5D-Y DS. [ABSTRACT FROM AUTHOR]

The validity of the standard ideal L2 self scale has increasingly been called into question. This paper reports both quantitative and qualitative investigations into whether the ideal L2 self items tap into the intended construct of an actual–ideal discrepancy. Study 1 involved an experimental approach manipulating the items to explicitly refer to ability beliefs. Data from 1,362 participants across three countries (Austria, China, and Saudi Arabia) showed a lack of discriminant validity between original and manipulated items. Study 2 used cognitive interviewing to examine the thought processes of 24 Japanese university students as they responded to ideal L2 self items. Thematic analysis revealed that responses were dominated by reflections on current ability and expectations about using the language in specific situations, rather than envisioning an idealised future self. The findings of Studies 1 and 2 converge to indicate that the standard ideal L2 self scale does not successfully operationalise the intended theoretical construct of actual–ideal self discrepancies. Instead, responses are mostly driven by beliefs about ability to achieve the states described in each item. The results therefore challenge the validity of this widely-used scale, calling for a reinterpretation of its findings in the L2 Motivational Self System literature. [ABSTRACT FROM AUTHOR]

Background: Gestational diabetes mellitus (GDM) is characterized by hyperglycemia during pregnancy. There are many diabetes-specific tools for collecting information validated in Brazilian Portuguese. However, there are no specific instruments to assess knowledge about GDM in Brazilian Portuguese. The aim of this study was to cross-culturally adapt and validate the Brazilian Portuguese version of the Knowledge of Gestational Diabetes Mellitus questionnaire (GDMKQ). Methods: This study was conducted in southern Brazil from January to December 2023. Women with GDM or diabetes identified during pregnancy were considered eligible based on specific criteria. Clinical and demographic data were obtained through a medical records search. The GDMKQ underwent a multistep adaptation process, including translation, back-translation, content validity assessment, and cognitive interviews. After administration to participants, internal consistency, item-total correlation, and intraclass correlation were assessed. Confirmatory factor analysis was also conducted to ensure validity. Results: A total of 155 pregnant women were recruited for the study. Most participants were aged 18–30 years, and hypertension was the main comorbidity (25.2%). Regarding education, most participants (58.7%) attended high school. The Brazilian Portuguese version of the GDMKQ consisted of 32 items. The intraclass correlation was established by two independent interviews with 57 participants, yielding a correlation coefficient of 0.79 (p < 0.01). Internal consistency (Cronbach's alpha) was 0.81 overall but was less than 0.7 for each domain. Item-total correlations were calculated, and confirmatory factor analysis indicated a good model fit. The final Brazilian Portuguese version of the questionnaire consisted of 32 items. Conclusions: The Brazilian Portuguese version of the GDMKQ yielded a reliable and valid tool for evaluating diabetes knowledge in pregnant women. [ABSTRACT FROM AUTHOR]

Background: Sexual and reproductive empowerment (SRE) is an important determinant of women's and girls' health yet measuring it is complex due to cultural and domain-specific variations. This study describes the process of adapting an SRE scale consisting of four domains (self-efficacy; future orientation; social support; and safety) and testing its psychometric properties among Arabic speaking adolescent girls in Lebanon. Methods: An SRE scale developed in a Western context was adapted in four steps: (1) reviewing the scale and selecting culturally appropriate domains for translation to standard Arabic; (2) conducting cognitive interviews with 30 11-17-year-old adolescent girls in Lebanon; (3) administering the scale to 339 refugee adolescent girls who participated in an early marriage intervention; and (4) conducting confirmatory factor analysis (CFA) on the data to assess the scale's psychometric properties. Results: The original model for the 13-item, four-domain adapted scale demonstrated poor fit in CFA. After iteratively removing two items, scale properties were improved, albeit were not optimal. The validity and reliability results for the self-efficacy domain were acceptable. Cognitive interview data revealed that Arab adolescent girls understood self-efficacy in relational terms, recognizing that autonomous decision-making is not necessarily favored but is influenced by parents and family. Conclusions: This study presents an effort to customize an SRE scale for use in studies on the health of adolescent girls in an Arab cultural context. Findings from cognitive interviews highlight the importance of taking into consideration relationality in adolescent sexual and reproductive decision-making. The self-efficacy domain in the adapted scale demonstrates acceptable psychometric properties and is recommended for use in health studies to capture SRE. [ABSTRACT FROM AUTHOR]

Background: Non-specific low back pain is a common and costly global issue. Many people with low back pain live for years with ongoing symptom recurrence and disability, making it crucial to find effective prevention strategies. Motivational interviewing (MI) is an evidence-based patient-centred counselling style that helps motivate individuals to change their behaviours. In combination, MI and cognitive-behavioural therapy (MI-CBT) has the potential to yield long term improvements in pain and disability and reduce incidence of recurrence. Method: This is a two-arm superiority randomised controlled trial comparing MI-CBT and Education (n = 83) with Education only (n = 83). Participants that have recovered from a recent episode of non-specific low back pain (7th consecutive day with pain ≤ 2 on a 0–10 numeric pain rating scale) will be eligible for inclusion into the study. Both groups will receive five 30-min sessions over a 10-week period as well as the Navigating Pain booklet, homework book and a standardised exercise programme. In the intervention group, MI-CBT techniques will be used to provide individualised support, identify beliefs, and increase engagement with the resources provided. Outcomes measures include pain (current and in the last 7 days) as rated on the numeric pain rating scale. This will be used to determine recurrence (number of participants who report back pain ≥ 3 out of 10 on the numeric pain rating scale). Furthermore, self-reported (1) pain intensity; (2) pain catastrophizing; (3) fear-avoidance beliefs; (4) pain self-efficacy; (5) depression and anxiety; (6) disability will be measured. All outcomes will be measured at baseline, and again at 3-, 6-, and 12-months post allocation. Discussion: The effective delivery of self-management strategies to prevent recurrence of low back pain is an important aspect that requires urgent attention. This study will provide new information on the effectiveness of using an MI-CBT approach to facilitate self-management through education and exercise to improve low back pain outcomes. Evidence emerging from this trial has the potential to inform clinical practice and healthcare management of non-specific low back pain. Trial registration: Prospectively registered with Australian New Zealand Clinical Trials Registry: ACTRN12623000746639 (10/07/2023). [ABSTRACT FROM AUTHOR]

Introduction Aim Methods Results Conclusions Currently, no quality‐of‐life instrument exists that captures the full experience of the mental health outlook (MHO), a coreHEM core outcome, in people with haemophilia, including the potential transformational experience of receiving gene therapy.To describe the methods used to develop a content validated patient‐reported outcome measure (PROM) that measures MHO for people with haemophilia.A conceptual framework, developed from a literature/evidence review, was used to create an interview guide and draft a questionnaire. Males aged 15 or older with severe/moderate haemophilia were eligible to participate in concept elicitation or cognitive debriefing interviews. The conceptual framework was refined based on a thematic analysis of concept elicitation interviews and PROM items were developed from the conceptual framework. Cognitive debriefing sessions that prioritised relevance and understanding of the PROM were held in two rounds; items were updated iteratively.A conceptual framework with five domains (stigma, anxiety, depression, life interference and identity) was constructed from over 300 identified MHO concepts. Fifty‐three participants took part in interviews. After 32 concept elicitation interviews, the framework was updated by including eight new sub‐concepts and eliminating two. Updates to the questionnaire included items added or removed and improved wording. The final coreHEM MHO PROM has 26 questions in two sections (general mental health associated with haemophilia, and a gene therapy section).The instrument is content‐validated and can be used as an exploratory outcome. MHO scores can be measured and compared to give more insight into patient quality of life. [ABSTRACT FROM AUTHOR]

Background: Comprehensive antenatal care (ANC) must prioritize competent, evidence-based medical attention to ensure a positive experience and value for its users. Unfortunately, there is scarce evidence of implementing this holistic approach to ANC in low- and middle-income countries, leading to gaps in quality and accountability. This study assessed care competence, women's experiences during the first ANC visit, and the factors associated with these care attributes. Methods and findings: The study analyzed cross-sectional baseline data from the maternal eCohort study conducted in Mexico from August to December 2023. The study adapted the Quality Evidence for Health System Transformation (QuEST) network questionnaires to the Mexican context and validated them through expert group and cognitive interviews with women. Pregnant women aged 18 to 49 who had their first ANC visit with a family physician were enrolled in 48 primary clinics of the Instituto Mexicano del Seguro Social across 8 states. Care competence and women's experiences with care were the primary outcomes. The statistical analysis comprised descriptive statistics, multivariable linear and Poisson regressions. A total of 1,390 pregnant women were included in the study. During their first ANC visit, women received only 67.7% of necessary clinical actions on average, and 52% rated their ANC experience as fair or poor. Women with previous pregnancies (adjusted regression coefficient [aCoef.] −3.55; (95% confidence intervals [95% CIs]): −4.88, −2.22, p < 0.001), at risk of depression (aCoef. −3.02; 95% CIs: −5.61, −0.43, p = 0.023), those with warning signs (aCoef. −2.84; 95% CIs: −4.65, −1.03, p = 0.003), common pregnancy discomforts (aCoef. −1.91; 95% CIs: −3.81, −0.02, p = 0.048), or those who had a visit duration of less than 20 minutes (<15 minutes: aCoef. −7.58; 95% CIs: −10.21, −4.95, p < 0.001 and 15 to 19 minutes: aCoef. −2.73; 95% CIs: −4.79, −0.67, p = 0.010) and received ANC in the West and Southeast regions (aCoef. −5.15; 95% CIs: −7.64, −2.66, p < 0.001 and aCoef. −5.33; 95% CIs: −7.85, −2.82, p < 0.001, respectively) had a higher probability of experiencing poorer care competence. Higher care competence (adjusted prevalence ratio [aPR] 1.004; 95% CIs:1.002, 1.005, p < 0.001) and receiving care in a small clinic (aPR 1.19; 95% CIs: 1.06, 1.34, p = 0.003) compared to a medium-sized clinic were associated with a better first ANC visit experience, while common pregnancy discomforts (aPR 0.94; 95% CIs: 0.89, 0.98, p = 0.005) and shorter visit length (aPR 0.94; 95% CIs: 0.88, 0.99, p = 0.039) were associated with lower women's experience. The primary limitation of the study is that participants' responses may be influenced by social desirability bias, leading them to provide socially acceptable responses. Conclusions: We found important gaps in adherence to ANC standards and that care competence during the first ANC visit is an important predictor of positive user experience. To inform quality improvement efforts, IMSS should institutionalize the routine monitoring of ANC competencies and ANC user experience. This will help identify poorly performing facilities and providers and address gaps in the provision of evidence-based and women-centered care. Svetlana V. Doubova and co-workers explore antenatal care across Mexico using data collected from >1300 pregnant women who reported their individual lived experiences. Author summary: Why was this study done?: High-quality antenatal care (ANC) is crucial for preventing, detecting, and managing maternal and newborn complications. It involves providing comprehensive care, prioritizing evidence-based medical attention, and ensuring positive experiences for women. How healthcare providers treat women during the first ANC visit is vital in determining their satisfaction and subsequent use of health services. There is little evidence of the implementation of this holistic approach to ANC in Latin America and other low- and middle-income countries. What did the researchers do and find?: The study used baseline data from the maternal eCohort in Mexico, collected through validated global QuEST network questionnaires adapted to the local context. The study gathered and analyzed an extensive number of user-reported experience measures and multiple health status variables to comprehensively assess women's experiences and healthcare competency during the first ANC visit, serving as a valuable model for other Latin American and low- and middle-income countries. Compared to prior studies in this field, which typically gather information within a 1-year recall period, we used a 2-week data collection timeline to minimize recall bias. We found that higher care competence was associated with a higher likelihood of women rating their care as high quality and reporting positive experiences during the first ANC visit. The study's main limitation is the potential for participants' answers to be influenced by social desirability bias (i.e., what they think others want to hear), leading to responses they believe are socially acceptable. What do these findings mean?: Evidence on care competence and women's experiences should inform efforts to improve ANC quality in Mexico and Latin America. Care competence is an important determinant of client satisfaction. The gaps in care competence should be addressed to ensure positive experiences during pregnancy. [ABSTRACT FROM AUTHOR]

Background: Post-intensive care syndrome (PICS) affects many critical care survivors and family members. Nevertheless, the relationship between PICS-relevant domains in cardiac arrest (CA) survivors and psychological distress in their family members (henceforth, PICS-F) remains underexplored. Methods: We enrolled consecutive CA patients admitted between 16 August 2021 and 28 June 2023 to an academic medical center, along with their close family members, in prospective studies. Survivors' PICS domains were: physical dependence (Physical Self-Maintenance Scale, PSMS), cognitive impairments (Modified Telephone Interview for Cognitive Status, TICS-M), and post-traumatic stress disorder (PTSS) symptoms (PTSD Checklist—PCL 5), as well as PICS-F (PCL-5 Total Score). Hierarchical multivariate linear regressions examined associations between PICS-F and survivors' PICS domains. Results: Of 74 dyads (n = 148), survivors had a mean (SD) age of 56 ± 16 years, with 61% being male and with a median hospital stay of 28 days. Family members (43% spouses) were slightly younger (52 ± 14 years), predominantly female (72%), and of minority race/ethnicity (62%). A high prevalence of PICS assessed 28.5 days (interquartile range 10–63) post-CA was observed in survivors (78% physical dependence, 54% cognitive impairment, 30% PTSS) and in family members (30% PTSS). Survivor PTSS was significantly associated with family member distress (β = 0.3, p = 0.02), independent of physical dependence (β = 0.0, p = 0.9), cognitive impairment (β = −0.1, p = 0.5), family member characteristics, and duration of hospitalization. Conclusions: Both CA survivors and their family members showed substantial evidence of likely PICS. Survivor PTSS is notably associated with family member distress, highlighting the need for dyadic interventions to enhance psychosocial outcomes. [ABSTRACT FROM AUTHOR]

Purpose: Performance status is an important concept in oncology, but is typically clinician-reported. Efforts are underway to include patient-reported measures in cancer care, which may improve patient symptoms, quality of life and overall survival. The purpose of this study was to gain a preliminary understanding of how patients determined their physical performance status based on a novel patient-reported version of the Eastern Cooperative Oncology Group Performance Status (ECOG) scale. Methods: We conducted qualitative interviews, including concept elicitation and cognitive interviewing as part of the Patient Reports of Physical Functioning Study (PROPS) to investigate how participants selected their answers to a novel patient-reported ECOG. Participants were administered the patient-reported ECOG and asked to describe devices and modifications used to keep up with daily activities. Results: Participants generally understood the ECOG as intended. Participants with recent changes in status had some difficulty selecting an answer. Most participants used modifications and assistive devices in their daily lives but did not incorporate these into their rational for the ECOG. Conclusion: The potential benefits of a patient-reported ECOG are numerous and this study demonstrates that participants were able to understand and answer the patient-reported ECOG as intended. We recommend future evaluation for the most-appropriate recall period, whether to include modifications in the ECOG instructions, and if increasing the number of response options to the patient-reported ECOG may improve confidence when providing an answer. [ABSTRACT FROM AUTHOR]

Research in psychology, sociology, economics, and other disciplines investigating social justice has identified associations between fair treatment and human well-being. However, the lack of a practical and valid instrument for measuring individual experiences of fair treatment in multiple areas of life has limited the ability to understand the relationship between fairness and wellness. The purpose of these studies was to develop and establish the initial psychometric properties and convergent validity of a scale measuring personal experiences of fairness across various life domains. Development and validation occurred across three studies. Scale development in Study 1 included the generation of items, item revision, and analysis of content validity. A review of existing literature and qualitative data derived from focus group discussions informed the initial pool of items. Cognitive interviews and expert input aided in analysis of content validity and revision of items. Study 2 consisted of confirmatory factor analyses to evaluate the performance of items and determine the underlying factor structure of the scale. In Study 3, factor analyses were used to evaluate convergent validity with other fairness-related instruments. Results of the first study supported the conceptualization of fairness along a social-ecological spectrum: experiences of fairness existed in multiple distinct life domains (e.g., interpersonal, occupational, community). Results from the second study revealed a bifactor model with one general Fairness factor and four Interpersonal, Occupational, Community, and Societal ecological group factors. Results from the third study suggested acceptable convergent validity among some subscales and other established instruments, while also suggesting that refinements to the Community fairness subscale might improve the scale. The final 12-item scale demonstrated good reliability. Results of this study produced an instrument able to measure individual experiences of fair treatment across four life domains. [ABSTRACT FROM AUTHOR]

Purpose: To translate and cross‐culturally adapt PREP2 into Danish and to investigate the face validity and reliability of Danish PREP2 through cognitive interviewing, Rasch and reliability analyses. Methods: The Danish PREP2 was translated using a standardized procedure and then pretested following the Three‐Steps‐Interviews (TSTI) process. A total of 15 myopic children aged 7–14 wearing either orthokeratology lenses (ortho‐k) or single‐vision spectacles (SVS) were included in pretesting comprising cognitive interviews and Rasch analysis. Data from cognitive interviewing was analysed thematically according to Collins. Rasch analysis was used to pretest the psychometric properties in terms of person‐ and item‐fit statistics. Reliability was assessed via test–retest using Intra‐class correlation coefficient (ICC) in the CONTROL study population, which consisted of 60 Danish children aged 7–14 years wearing either ortho‐k or SVS. Results: Fifteen children participated in pilot studies comprising of cognitive interviewing and Rasch analysis and 44 out of 60 CONTROL children participated in test–retest reliability analysis. The translation process resulted in a Danish version of PREP2 corroborating the original. Pretesting highlighted issues in the contextualization of items and in marking responses. Thus, we introduced a digital format with help texts. Cognitive interviewing identified issues in the following Collins' themes: comprehension (understanding of concepts), judgement (ambiguity of items) and response (selecting answers). Rasch analysis indicated that help texts were useful for clarifying context. The ICC was 0.77 (95% CI: 0.66–0.85). Conclusions: The cross‐cultural adaptation of PREP2 was satisfactory and issues were identified and corrected through pretesting. The test–retest reliability showed substantial consistency. The instrument could be validated in a more generalizable setting in future studies. Trial registration: NCT03246464 (CONTROL study). [ABSTRACT FROM AUTHOR]

The prevalence of youth vaping has, in a relatively short time, become an "epidemic." In the wake of such labeling by the Surgeon General, a number of important examinations of vaping have been conducted. These have largely focused on high school and college‐age youth as this demographic shows the greatest prevalence of use. Nonetheless, no measure has been made available which might allow for the comprehensive assessment of quantity and frequency of vaping among this age group, thus aiding in standardization across settings. The current study utilized cognitive interviews with high school and college‐age youth who use vaping devices to inform the preliminary development of such an assessment. The sample consists of eight students between the ages of 15 and 24 (Mage = 18.75, SD = 2.73, 62.5% female, 75.0% Hispanic/Latino/a/x, 100.0% White). Interviewing and measure refinement were conducted in a two‐phase iterative fashion. Suggestions made during cognitive interviews resulted in the refinement of assessed content type, updated categories and pictures of vaping devices, as well as updated and age‐relevant terminology. Further, instructions were streamlined, and assessment items and multiple‐choice options were refined to maximize clarity and to minimize participant confusion. The result of this study, the E‐Cigarette Assessment for Youth Revised, is a unique tool for standardizing examinations of the quantity and frequency of vaping behaviors among high school students and college‐age youth. [ABSTRACT FROM AUTHOR]

The Cognitive Assessment Interview (CAI) is an interview-based scale measuring cognitive impairment and its impact on functioning in subjects with schizophrenia (SCZ). The present study aimed at assessing, in a large sample of SCZ (n = 601), the agreement between patients and their informants on CAI ratings, to explore patients' insight in their cognitive deficits and its relationships with clinical and functional indices. Agreement between patient- and informant-based ratings was assessed by the Gwet's agreement coefficient. Predictors of insight in cognitive deficits were explored by stepwise multiple regression analyses. Patients reported lower severity of cognitive impairment vs. informants. A substantial to almost perfect agreement was observed between patients' and informants' ratings. Lower insight in cognitive deficits was associated to greater severity of neurocognitive impairment and positive symptoms, lower severity of depressive symptoms, and older age. Worse real-life functioning was associated to lower insight in cognitive deficit, worse neurocognitive performance, and worse functional capacity. Our findings indicate that the CAI is a valid co-primary measure with the interview to patients providing a reliable assessment of their cognitive deficits. In the absence of informants with good knowledge of the subject, the interview to the patient may represent a valid alternative. [ABSTRACT FROM AUTHOR]

Researchers and practitioners need robust measurement tools for evaluating knowledge of child development to better support parents and their children during pregnancy and the transition to parenthood. We addressed this need by evaluating the psychometric properties of the Domains of Development Instrument (DoDI) for measuring knowledge of developmental milestones from birth to 3 years. We evaluated four types of validity evidence for the DoDI: test content, response processes, internal structure, and relations to other variables. We convened an expert panel to evaluate test content and conducted cognitive interviews with mothers to evaluate response processes. We also collected responses from a sample of 418 English-speaking pregnant women to evaluate internal structure and relations to other variables. We observed content validity and response process validity, as well as the predicted internal structure, internal consistency, test–retest reliability, and convergent validity. We conclude with recommendations for future research with the DoDI. [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: We lack a comprehensive validated Danish questionnaire to evaluate symptoms and bother regarding anal incontinence (AI). The International Consultation on Incontinence Questionnaire‐Bowel (ICIQ‐B) is an internationally recommended questionnaire containing 21 items, of which 17 are scored in three subscales: bowel pattern, bowel control, and quality of life. Aims: To translate the ICIQ‐B into Danish and to validate the Danish version in pelvic floor disorder (PFD) patients with and without AI. Methods: The ICIQ‐B was translated by a panel of healthcare professionals followed by cognitive interviews with PFD patients attending an outpatient clinic. Revisions were undertaken using an iterative process, and a backward translation was performed for the final version. Pretesting and test‐retest of the ICIQ‐B were done online and administrated together with the St. Mark's score. Content, structural, convergent and discriminant validity were assessed, followed by an evaluation of relative and absolute reliability, including the smallest real difference (SRD). Results: Thirty cognitive patient interviews were performed, resulting in three revisions. The Danish ICIQ‐B was found to be comprehensible and relevant but lacked items addressing the psychological impact of bowel problems. The ICIQ‐B was completed online by 227 PFD patients with and without AI. The structural validity of the bowel pattern subscale could not be retrieved. Patients indicating AI had significantly higher ICIQ‐B and St. Mark's scores than patients without AI, and ICIQ‐B subscale scores correlated moderately with St. Mark's scores. Internal consistency was good except for the bowel pattern subscale. Seventy‐six patients completed test‐retest. Relative reliability was excellent for subscale scores and moderate or good for single items except for the item concerning stool consistency, which was weak. The SRD was found to be 2.8 for the bowel pattern subscale, 4.3 for bowel control subscale, and 3.6 for the quality‐of‐life subscale. Conclusion: The Danish version of the ICIQ‐B can be used for Danish patients with PFD, and discriminant validity is good. The structural validity and the internal consistency of the bowel pattern subscale are questionable, indicating that some items do not represent the underlying construct. Test‐retest reliability of the ICIQ‐B is acceptable, but the change needed to reflect a real change above the measurement error in each subscale is three to four points. [ABSTRACT FROM AUTHOR]