Rounds Of Cognitive Interviews Research Articles

Linguistic validation of the Spanish version of the Anal Cancer High-Grade squamous intraepithelial lesions outcomes Research Health-Related Symptom Index (A-HRSI): AMC-A04

ObjectivesThe Anal Cancer High-grade squamous intraepithelial lesions (HSIL) Outcomes Research (ANCHOR) Health-Related Symptom Index (A-HRSI) is a 25-item measure that assesses physical symptoms and impacts, and psychological symptoms. To promote generalizability and equity in the capture of these concepts in Spanish-speaking participants, we linguistically validated a Spanish version of A-HRSI.MethodsFollowing independent forward translation and reconciliation of A-HRSI from English to Spanish, two rounds of cognitive interviews were completed with ANCHOR participants who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish. Interviews were coded to highlight any items and concepts that were reported as being difficult for any reason by ≥ 3 participants, with such items revised during a research team panel discussion and tested in a second round of interviews if applicable.ResultsSeventeen participants representing 8 nationalities were enrolled (Round 1 n=10, Round 2 n=7); 7 participants reported not completing high school (41.2%). No difficulties were reported with respect to the theoretical concepts measured by A-HRSI. We made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s).ConclusionThe Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL.Plain English SummaryLanguage is a tremendous barrier to enrolling patients to clinical trials. The anal cancer high-grade squamous intraepithelial lesions (HSIL) outcomes research [ANCHOR] trial is a randomized clinical trial that recently established that the treatment of anal HSIL, versus active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV (PLWH). The ANCHOR Health-Related Symptom Index (A-HRSI) is a 25-item patient-reported outcomes measure that was developed to assess physical symptoms, physical impacts, and psychological symptoms related to anal HSIL. As approximately 10% of ANCHOR participants preferred the delivery of their healthcare in Spanish, the purpose of the present study was to linguistically validate a Spanish version of A-HRSI. Based on feedback from interviews with 17 participants from the ANCHOR trial who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish, we made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL as part of clinical trials or routine care.

Cognitive testing of a survey instrument to assess sexual practices, behaviours, and health outcomes: a multi-country study protocol

BackgroundPopulation level data on sexual practices, behaviours and health-related outcomes can ensure that responsive, relevant health services are available for all people of all ages. However, while billions of dollars have been invested in attempting to improve sexual and reproductive health (including HIV) outcomes, far less is understood about associated sexual practices and behaviours. Therefore, the World Health Organization embarked on a global consultative process to develop a short survey instrument to assess sexual health practices, behaviours and health outcomes. In order for the resulting draft survey instrument to be published as a ‘global’ standard instrument, it is important to first determine that the proposed measures are globally comprehensible and applicable.This paper describes a multi-country study protocol to assess the interpretability and comparability of the survey instrument in a number of diverse countries.MethodsThis study will use cognitive interviewing, a qualitative data collection method that uses semi-structured interviews to explore how participants process and respond to survey instruments. We aim to include study sites in up to 20 countries. The study procedures consist of: (1) localizing the instrument using forward and back-translation; (2) using a series of cognitive interviews to understand how participants engage with each survey question; (3) revising the core instrument based on interview findings; and (4) conducting an optional second round of cognitive interviews. Data generated from interviews will be summarised into a predeveloped analysis matrix.The entire process (a ‘wave’ of data collection) will be completed simultaneously by 5+ countries, with a total of three waves. This stepwise approach facilitates iterative improvements and sharing across countries.DiscussionAn important output from this research will be a revised survey instrument, which when subsequently published, can contribute to improving the comparability across contexts of measures of sexual practices, behaviours and health-related outcomes. Site-specific results of the feasibility of conducting this research may help shift perceptions of who and what can be included in sexual health-related research.

Portuguese Physical Literacy Assessment Questionnaire (PPLA-Q) for adolescents (15\u201318\u2009years) from grades 10\u201312: development, content validation and pilot testing

BackgroundThe Portuguese Physical Literacy Assessment (PPLA) is a novel tool to assess high-school students’ (grade 10–12; 15–18 years) Physical Literacy (PL) in Physical Education (PE); inspired by the four domains of the Australian Physical Literacy Framework (APLF), and the Portuguese PE syllabus. This paper describes the development, content validation, and pilot testing of the PPLA-Questionnaire (PPLA-Q), one of two instruments in the PPLA, comprised of modules to assess the psychological, social, and part of the cognitive domain of PL.MethodsDevelopment was supported by previous work, analysis of the APLF, and literature review. We iteratively gathered evidence on content validity through two rounds of qualitative and quantitative expert validation (n = 11); three rounds of cognitive interviews with high-school students (n = 12); and multiple instances of expert advisor input. A pilot study in two grade 10 classes (n = 41) assessed feasibility, preliminary reliability, item difficulty and discrimination.ResultsInitial versions of the PPLA-Q gathered evidence in favor of adequate content validity at item level: most items had an Item-Content Validity Index ≥.78 and Cohen’s κ ≥ .76. At module-level, S-CVI/Ave and UA were .87/.60, .98/.93 and .96/.84 for the cognitive, psychological, and social modules, respectively. Through the pilot study, we found evidence for feasibility, preliminary subscale and item reliability, difficulty, and discrimination. Items were reviewed through qualitative methods until saturation. Current PPLA-Q consists of 3 modules: cognitive (knowledge test with 10 items), psychological (46 Likert-type items) and social (43 Likert-type items).ConclusionResults of this study provide evidence for content validity, feasibility within PE setting and preliminary reliability of the PPLA-Q as an instrument to assess the psychological, social, and part of the cognitive domain of PL in grade 10 to 12 adolescents. Further validation and development are needed to establish construct validity and reliability, and study PPLA-Q’s integration with the PPLA-Observation (an instrument in development to assess the remaining domains of PL) within the PPLA framework.

Sexual and Gender Minority Persons’ Perception of the Female Sexual Function Index

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

The Newcastle ENDOPREM™: a validated patient reported experience measure for gastrointestinal endoscopy

ObjectivesMeasuring patient experience of gastrointestinal (GI) procedures is a key component of evaluation of quality of care. Current measures of patient experience within GI endoscopy are largely clinician derived and...

Collecting data on end-of-life decision-making: Questionnaire translation, adaptation and validity assessment

Little is known in Australia about current practice relating to medical end-of-life decisions preceding patient deaths. This study aimed to translate and culturally adapt a European questionnaire on medical end-of-life decisions and end-of-life care to the Australian context, producing a questionnaire to assess current medical practice in Australia and enable comparison with international studies. Following initial research team review, an English translation of the questionnaire was culturally adapted using four waves of cognitive pre-testing interviews with members of the target community: Australian doctors (n=27) from different specialties, clinical settings and geographical locations. Cognitive interviewing was used to identify potential problems with the translated questionnaire by examining the cognitive processes participants used to answer questions. Two experts in end-of-life research provided feedback on the questionnaire after the third wave of cognitive interviews. Research team review occurred again after the third and fourth waves of cognitive interviews. Interview notes were reviewed, coded and analysed using content analysis. A consensus approach was used to identify necessary adaptations, with all members of the research team endorsing the adaptations. Following cognitive pre-testing, an online version of the questionnaire was piloted with doctors, nurses and health law researchers (n=13). Improvements to questionnaire wording, flow/routeing and design were identified during the cognitive interviewing and piloting process and implemented. Saturation in terms of face and content validity and acceptability of the questionnaire was achieved after four rounds of cognitive interviews. Participants generally agreed that the adapted questionnaire instructions were easy to follow, the questions were easy to understand, they felt comfortable answering all the questions, and the online questionnaire format was user friendly. The time taken to complete the questionnaire (average 9.2 min) was also acceptable to participants. Cognitive interviewing was a suitable method for identifying and solving challenges with comprehension and applicability of the questionnaire within the Australian context. The final questionnaire was well accepted by doctors and is now being used in a study exploring the incidence and nature of medical end-of-life decisions involving adult patients in one Australian state (Victoria). This questionnaire may be suitable for use or further adaptation in research in other English speaking jurisdictions.

Development and content validation of the Satisfaction and Experience Questionnaire for Granulocyte Colony-Stimulating Factor (SEQ-G-CSF)

BackgroundSeveral options for granulocyte colony-stimulating factor (G-CSF) prophylaxis of chemotherapy-induced febrile neutropenia are available to patients worldwide. We have developed a novel patient-reported outcome measure, the Satisfaction and Experience Questionnaire for G-CSF (SEQ-G-CSF), to help understand patients’ perspectives of and satisfaction with different G-CSF options.ResultsThree oncology nurses and 40 adult oncology patients in the United States were enrolled and participated in focus group discussions to develop and refine the SEQ-G-CSF. Nurses had ≥ 5 years of experience treating oncology patients and were currently involved in the management of oncology patients receiving G-CSF prophylaxis. The patients had breast cancer, lung cancer, non-Hodgkin lymphoma, or prostate cancer (10 patients in each group) and were receiving G-CSF prophylaxis via injection or the on-body injector (OBI) device. The preliminary SEQ-G-CSF contained an item relevance questionnaire and three SEQ modules (sociodemographic, medical history, and G-CSF–related healthcare characteristics questionnaires). Twenty-one patients (53% of total sample size) discussed their experience and satisfaction with G-CSF. Their most common experiences were G-CSF effectiveness, convenience and benefits of the OBI, and relationships with healthcare providers. Side effects and having to undergo additional treatment were also reported. Satisfaction with aspects of G-CSF included the OBI and effectiveness of G-CSF treatment; dissatisfaction included inconvenience (having to return to the clinic the next day and administration of the injection) and the insurance approval process. The SEQ-G-CSF was finalized after three rounds of cognitive interviews and includes five domains related to general satisfaction (one item), treatment burden (four items), travel burden (two items), time burden (four items), and treatment compliance (two items).ConclusionsThe SEQ-G-CSF is a novel instrument that quantifies a patient’s experience and satisfaction with different G-CSF options using 13 easy-to-understand items. This study provides evidence for the content validity of SEQ-G-CSF. Although further psychometric testing is required, the SEQ-G-CSF may be a useful addition to clinical trials, observational studies, and clinical practice.

Using Cognitive Interviewing to Design Interventions for Implementation in Oncology Settings.

Implementation of effective interventions into clinical practice is slow, in large part, because researchers do not sufficiently attend to the realities of nurses who implement interventions. The aim of the study was to provide an exemplar of how cognitive interviewing-an important and underused method for developing nursing research-can be used to design survey items and assess multilevel implementation factors. We utilized the Consolidated Framework for Implementation Research to create a survey to assess factors that influence how oncology nurses deliver physical activity interventions. Two rounds of cognitive interviews were conducted with five purposively selected oncology nurses to assess survey items' clarity and effectiveness at eliciting desired information. We used a cognitive interviewing coding scheme to code data and revise unclear items. Participants completed the revised survey online and underwent a second interview to provide additional feedback. Seven important changes were made to the survey: how to assess nurses' perceptions of other nurses' beliefs and practices; language to capture data relating to nursing leadership and administration; increased detail to assess factors related to nurses' workplaces; language related to capturing factors related to policy; language to capture data related to equity, disparities, and cultural tailoring; terms replacement with language used by nurses; and strategy to capture data about nurses' knowledge of national physical activity recommendations for cancer survivors. Cognitive interviewing can be applied to develop survey items that capture real-world experiences and perspectives of practicing nurses. This is an essential step in developing nursing interventions that are ready to be implemented and increasing the uptake of evidence-based nursing care. Cognitive interviewing can be used across nursing settings, populations, and interventions to develop understandings of attitudes, attributes, characteristics, and perceptions for a variety of nursing interventions.

Linguistic validation of the simplified Chinese version of the US National Cancer Institute\u2019s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE\u2122)

BackgroundThe aim of this study was to translate and linguistically validate the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) into Simplified Chinese for use in Singapore.MethodsAll 124 items of the English source PRO-CTCAE item library were translated into Simplified Chinese using internationally established translation procedures. Two rounds of cognitive interviews were conducted with 96 cancer patients undergoing adjuvant treatment to determine if the translations adequately captured the PRO-CTCAE source concepts, and to evaluate comprehension, clarity and ease of judgement. Interview probes addressed the 78 PRO-CTCAE symptom terms (e.g. fatigue), as well as the attributes (e.g. severity), response choices, and phrasing of ‘at its worst’. Items that met the a priori threshold of ≥20% of participants with comprehension difficulties were considered for rephrasing and retesting. Items where < 20% of the sample experienced comprehension difficulties were also considered for rephrasing if better phrasing options were available.ResultsA majority of PRO-CTCAE-Simplified Chinese items were well comprehended by participants in Round 1. One item posed difficulties in ≥20% and was revised. Two items presented difficulties in < 20% but were revised as there were preferred alternative phrasings. Twenty-four items presented difficulties in < 10% of respondents. Of these, eleven items were revised to an alternative preferred phrasing, four items were revised to include synonyms. Revised items were tested in Round 2 and demonstrated satisfactory comprehension.ConclusionsPRO-CTCAE-Simplified Chinese has been successfully developed and linguistically validated in a sample of cancer patients residing in Singapore.

Assessment of shared decision making in pediatrics: Developing German scales for patients aged 7–18 years, parents and parent-proxy reports (CollaboRATEpediatric)

ObjectiveTo develop parsimonious German scales (CollaboRATEpediatric) to assess shared decision making (SDM) with patients aged 7-18 years, parents and parents on behalf of their children (parent-proxy reports), and to establish comprehensibility and preliminary face validity. MethodsBased on an existing SDM scale for adults (CollaboRATE) we developed CollaboRATEpediatric in a two-step approach: (1) team-based translation of the English CollaboRATE scale into German and adaptation for pediatric patients, parents and parent-proxy reports, followed by (2) iterative revisions of the CollaboRATEpediatric scales based on cognitive interviews with patients and parents until comprehensibility and preliminary face validity were established. ResultsTaking into account seven problem areas identified in four rounds of cognitive interviews (e.g., item complexity) we developed CollaboRATEpediatric scales for patients, parents and parent-proxy reports. By iteratively revising items we were able to resolve all problem areas and achieved full comprehensibility and intended interpretation of all items. ConclusionThe scales enable the parsimonious assessment of SDM with pediatric patients and parents as well as comparisons between the two groups. Future empirical work will establish the psychometric performance of CollaboRATEpediatric. Practice ImplicationsCollaboRATEpediatric can be used in quality improvement initiatives to foster the comprehensive implementation of SDM in pediatrics.

4284 Development of a Survey Instrument to Predict Uptake of and Adherence to Active Surveillance among Men with Low-Risk Prostate Cancer

OBJECTIVES/GOALS: Active surveillance (AS) is a recognized strategy to manage low-risk prostate cancer (PCa) in the absence of cancer progression. Little prospective data exists on the decisional factors associated with selecting and adhering to AS in the absence of cancer progression. We developed a survey instrument to predict AS uptake and adherence. METHODS/STUDY POPULATION: We utilized a three-step process to develop and refine a survey instrument designed to predict AS uptake and adherence among men with low-risk PCa: 1) We identified relevant conceptual domains based on prior research and a literature review. 2) We conducted 21 semi-structured concept elicitation interviews to identify patient-perceived barriers and facilitators to AS uptake and adherence among men with a low-risk PCa who had been on AS for ≥1 year. The identified concepts became the basis of our draft survey instrument. 3) We conducted two rounds of cognitive interviews with men with low-risk PCa (n = 12; n = 6) to refine and initially validate the instrument. RESULTS/ANTICIPATED RESULTS: Relevant concepts identified from the initial interviews included the importance of patient: knowledge of their PCa risk, value in delaying treatment, trust in urologist and the AS surveillance protocol, and perceived social support. Initially, the survey was drafted as a single instrument to be administered after a patient had selected AS comprising sections on patient health, AS selection, and AS adherence. Based on the first round of cognitive interviews, we revised the single instrument into two surveys to track shifts in patient preference and experience. The first, administered at diagnosis, focuses on selection, and the second, a 6-month follow up, focuses on adherence. Following revisions, participants indicated the revised 2-part instrument was clear and not burdensome to complete. DISCUSSION/SIGNIFICANCE OF IMPACT: The instrument’s content validity was evaluated through cognitive interviews, which supported that the survey items’ intended and understood meanings were isomorphic. In the next phase, we plan to conduct a large-scale prospective cohort study to evaluate the predictive validity, after which it will be available for public research use.

Development of a Comprehensive Questionnaire Evaluating Knowledge, Attitudes, and Practices Regarding University Student Food Access Resource Use

Abstract Objectives To develop a comprehensive questionnaire which assesses food security and knowledge, attitudes, and practices (KAPs) regarding food access resources at a large public university. Methods A comprehensive food security and food resource questionnaire was developed by a panel of nutrition and survey design experts for use with university students. The questionnaire underwent two rounds of cognitive interviews with a diverse group of university students to ensure questions were understood as intended. Feedback from the first round of cognitive interviews was used to inform changes and improve clarity. The second round of cognitive interviews was used to clarify changes made to the questionnaire during the first round of interviews. Following the cognitive interviews, the questionnaire was reviewed by the panel of nutrition and survey design experts and finalized. Results Following a systematic approach, a comprehensive questionnaire was developed and finalized for use with university students. The initial questionnaire contained 40 questions. Following the first round of cognitive interviews (n = 15 students) 34 questions were revised, 7 questions were added and 1 question was removed. Following the second round of cognitive interviews (n = 10 students), Likert-scale questions were edited for simplicity, and question formatting was edited to emphasize differences in questions that were otherwise identical. Before distribution, 7 questions about food choice were added, food security screening questions were added, and skip-logic was incorporated into the questionnaire and tested. Conclusions The final questionnaire evaluates food resource KAPs and contains 68 items, including questions from the 10-item USDA Food Security Module, and newly developed questions regarding student food choice motivations, sugar-sweetened beverage consumption habits, knowledge/awareness of food access resources, perceptions of food access resources, current student concerns/stressors, and financial considerations. This newly developed questionnaire has been distributed to 10,000 University of California, Davis students. Future applications for this questionnaire include distribution at other universities and colleges within California. Funding Sources This project was funded by an internal University of California, Davis research grant.

The Cystic Fibrosis Impact Questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis

BackgroundPatients with cystic fibrosis (CF) experience significant disease burden, including progressive pulmonary decline and reduced survival. This multicenter qualitative study was conducted to develop a new patient-reported outcome (PRO) measure to assess the impact of CF on patients’ quality of life: the Cystic Fibrosis Impact Questionnaire (CF-IQ).Semi-structured qualitative concept elicitation (CE) interviews with patients and caregivers documented CF-related symptoms, impacts, and treatment experiences. Coded interview data were considered alongside existing PROs, published literature, and expert opinion to develop an initial scale. Three rounds of cognitive interviews evaluated respondent comprehension and facilitated refinement of the CF-IQ.ResultsAdult (N = 20) and pediatric (N = 22) patients with CF and their parents/caregivers (N = 22) completed CE interviews at 7 US clinics. The sample included patients aged 6–58 years, 57% females, and represented a broad range of disease severity (forced expiratory volume in 1 s range: 22%–127% predicted). Interviews identified 59 unique CF-related impact concepts in domains, including activity limitations (physical, social, leisure), functional limitations (school, work), vulnerability/lack of control, emotional impact, treatment burden, and future outlook. Concept saturation was achieved, and a draft questionnaire was developed. Findings from the cognitive interviews (n = 18) confirmed that instructions, items, and response scales were relevant and clear, and interpreted as intended by patients.ConclusionThe CF-IQ is a 40-item novel PRO scale assessing a comprehensive set of patient-relevant concepts to characterize the multifaceted nature of CF. Qualitative interview data support the content validity of the CF-IQ, which is currently undergoing additional psychometric evaluation in patients with CF.

Development and Psychometric Properties of a Questionnaire Assessing Self-Reported Generic Health Literacy in Adolescence.

Health literacy is a promising approach to promoting health and preventing disease among children and adolescents. Promoting health literacy in early stages of life could contribute to reducing health inequalities. However, it is difficult to identify concrete needs for action as there are few age-adjusted measures to assess generic health literacy in young people. Our aim was to develop a multidimensional measure of health literacy in German to assess generic health literacy among 14- to 17-year-old adolescents, namely, the “Measurement of Health Literacy Among Adolescents Questionnaire” (MOHLAA-Q). The development process included two stages. Stage 1 comprised the development and validation using a literature review, two rounds of cognitive interviews, two focus groups and two rounds of expert assessments by health literacy experts. Stage 2 included a standard pretest (n = 625) of the questionnaire draft to examine the psychometric properties, reliability and different validity aspects. The MOHLAA-Q consists of 29 items in four scales: (A) “Dealing with health-related information (HLS-EU-Q12-adolescents-DE)”; (B) “Communication and interaction skills”, (C) “Attitudes toward one’s own health and health information”, and (D) “Health-related knowledge”. The confirmatory factor analysis indicated a multidimensional structure of the MOHLAA-Q. The internal consistency coefficients (Cronbach’s α) of the scales varied from 0.54 to 0.77. The development of the MOHLAA-Q constitutes a significant step towards the comprehensive measurement of adolescents’ health literacy. However, further research is necessary to re-examine its structural validity and to improve the internal consistency of two scales.

Brazilian-Portuguese Linguistic Validation of the Velopharyngeal Insufficiency Effects on Life Outcome Instrument.

The purpose of this study was to conduct a linguistic validation of the velopharyngeal insufficiency (VPI) Effects on Life Outcome (VELO) instrument for use in Brazilian-Portuguese patients with VPI. The original English version of the VELO instrument was translated into Brazilian-Portuguese, back-translated, and adapted among the Brazilian patients (n = 21) with VPI and their parents, based on the standardized guidelines for the cross-culture adaption process. Discrepancies in the forward and backward translation steps were computed. Comprehension rates were captured for each debriefing interview. The content validity index (CVI) per item (I-CVI) and of the scale (S-CVI universal agreement [S-CVI/UA] and averaging [S-CVI/Ave]) were calculated. Reconciliation of the 2 forward translations and the comparison between the back translation and the original VELO version resulted in some item wordings with discrepancies which were reviewed by the research team (translators, expert committee, and original developers of instrument). Three rounds of cognitive interviews also led to some revisions of wording. Comprehension rates of patients and their parents were 60% to 100%, 80% to 100%, and 100% in the first, second, and third rounds of cognitive interviews, respectively. The I-CVI, S-CVI/AU, and SCI/Ave for the Brazilian-Portuguese VELO version were 0.83 (or higher), 0.83 (or higher), and 0.97, respectively. The linguistic validation process of the VELO instrument created a cross-culturally equivalent Brazilian-Portuguese version for use in Brazilian-Portuguese speaking patients with VPI.

Translation and linguistic validation of the implementation leadership scale in Chinese nursing context.

To translate the Implementation Leadership Scale (ILS) into Chinese and evaluate how Chinese nursing staff and leaders understood and responded to the Chinese ILS. Leadership is a critical factor for implementing evidence-based practice. The ILS is a valid and reliable instrument to understand leadership for evidence-based practice; however, this scale or the other similar instrument does not exist in Chinese. We followed the translation and cross-cultural validation guideline developed by Sousa and Rojjanasrirat. Translation included two forward and blind backward translations, and their comparisons. Two rounds of cognitive interview were used to evaluate the linguistic validity. The translation process took 12months. In the forward and backward translations, 24 translation issues were identified, of which semantic equivalence issues were most frequent. Ten nurses participated in each round of cognitive interviews and 33 linguistic issues were found. The final Chinese ILS had seven significant adaptations to the original instrument. This study provided a deep understanding of using the ILS in the local context and laid the foundation for future psychometric statistical testing. Implementation leadership scale could support organisational leadership development programmes and strategies to facilitate and support EBP implementation and sustainability.

Towards an assessment instrument for suffering in patients with psychiatric conditions: assessing cognitive validity.

Unbearable suffering is a key criterion in legally granting patients' euthanasia requests in Belgium yet a generally accepted definition of unbearable suffering remains elusive. The ability to understand and assess unbearable suffering is essential, particularly in patients with psychiatric conditions, as the underlying causes of these conditions are not always apparent. To enable research into when and why suffering experiences incite patients with psychiatric conditions to request euthanasia, and to help explore preventive and curative perspectives, the development of an assessment instrument is needed. To improve the cognitive validity of a large initial item pool used to assess the nature and extent of suffering in patients with psychiatric conditions. Cognitive validity was established via two rounds of cognitive interviews with patients with psychiatric conditions with (n = 9) and without (n = 5) euthanasia requests. During the first round of cognitive interviews, a variety of issues relating to content, form and language were reported and aspects that were missing were identified. During the second round, the items that had been amended were perceived as sufficiently easily to understand, sensitive to delicate nuances, comprehensive and easy to answer accurately. Neither research topic nor method were perceived as emotionally strenuous, but instead as positive, relevant, comforting and valuable. This research resulted in an item pool that covers the concept of suffering more adequately and comprehensively. Further research endeavours should examine potential differences in suffering experiences over time and in patients with psychiatric conditions with and without euthanasia requests. The appreciation patients demonstrated regarding their ability to speak extensively and openly about their suffering and wish to die further supports the need to allow patients to speak freely and honestly during consultations. None.

A Modular Health-Related Quality of Life Instrument for Electronic Assessment and Treatment Monitoring: Web-Based Development and Psychometric Validation of Core Thrive Items.

BackgroundPatient-reported outcome (PRO) measures describe natural history, manage disease, and measure the effects of interventions in trials. Patients themselves increasingly use Web-based PRO tools to track their progress, share their data, and even self-experiment. However, existing PROs have limitations such as being: designed for paper (not screens), long and burdensome, negatively framed, under onerous licensing restrictions, either too generic or too specific.ObjectiveThis study aimed to develop and validate the core items of a modular, patient-centric, PRO system (Thrive) that could measure health status across a range of chronic conditions with minimal burden.MethodsThrive was developed in 4 phases, largely consistent with Food and Drug Administration guidance regarding PRO development. First, preliminary core items (common across multiple conditions: core Thrive items) were developed through literature review, analysis of approximately 20 existing PROs on PatientsLikeMe, and feedback from psychometric and content experts. Second, 2 rounds of cognitive interviews were iteratively conducted with patients (N=14) to obtain feedback on the preliminary items. Third, core Thrive items were administered electronically along with comparator measures, including 20-item Short-Form General Health Survey (SF)-20 and Patient Health Questionnaire (PHQ)-9, to a large sample (N=2002) of adults with chronic diseases through the PatientsLikeMe platform. On the basis of theoretical and empirical rationale, items were revised or removed. Fourth, the revised core Thrive items were administered to another sample of patients (N=704) with generic and condition-specific comparator measures. A psychometric evaluation, which included both modern and classical test theory approaches, was conducted on these items, and several more items were removed.ResultsCognitive interviews helped to remove confusing or redundant items. Empirical testing of subscales revealed good internal consistency (Cronbach alpha=.712-.879), test-retest reliability (absolute intraclass correlations=.749-.912), and convergent validity with legacy PRO scales (eg, Pearson r=.5-.75 between Thrive subscales and PHQ-9 total). The finalized instrument consists of a 19-item core including 5 multi-item subscales: Core symptoms, Abilities, Mobility, Sleep, and Thriving. Results provide evidence of construct (content, convergent) validity, high levels of test-retest and internal consistency reliability, and the ability to detect change over time. The items did not exhibit bias based on gender or age, and the items generally functioned similarly across conditions. These results support the use of Thrive Core items across diverse chronic patient populations.ConclusionsThrive appears to be a useful approach for capturing important domains for patients with chronic conditions. This core set serves as a foundation to begin developing modular condition-specific versions in the near future. Cross-walking against traditional PROs from the PatientsLikeMe platform is underway, in addition to clinical validation and comparison with biomarkers. Thrive is licensed under Creative Commons Attribution ShareAlike 4.0.

Development of a Questionnaire to Evaluate Out-of-Home Participation for People With Dementia.

We describe the development of a questionnaire, Participation in Activities and Places Outside Home (ACT-OUT), for older adults with cognitive impairment and align it to people with mild- to moderate-stage dementia. ACT-OUT was developed in a cross-cultural collaboration in combination with three rounds of cognitive interviews in Switzerland with 26 older adults without cognitive impairment and five older adults with dementia. Qualitative data from the interviews were analyzed using a constant comparison approach. The final ACT-OUT Version 1.0 consists of three parts: (1) questions targeting places older adults visit; (2) questions on aspects influencing participation, such as transportation, familiarity, and risk perception; and (3) questions on perception of self. The development of an instrument such as ACT-OUT is more a cyclical than a linear process. This study is a first step toward a more systematic evaluation of out-of-home participation among older adults with and without dementia.

Improving the normalization of complex interventions: part 1 - development of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT)

BackgroundUnderstanding and measuring implementation processes is a key challenge for implementation researchers. This study draws on Normalization Process Theory (NPT) to develop an instrument that can be applied to assess, monitor or measure factors likely to affect normalization from the perspective of implementation participants.MethodsAn iterative process of instrument development was undertaken using the following methods: theoretical elaboration, item generation and item reduction (team workshops); item appraisal (QAS-99); cognitive testing with complex intervention teams; theory re-validation with NPT experts; and pilot testing of instrument.ResultsWe initially generated 112 potential questionnaire items; these were then reduced to 47 through team workshops and item appraisal. No concerns about item wording and construction were raised through the item appraisal process. We undertook three rounds of cognitive interviews with professionals (n = 30) involved in the development, evaluation, delivery or reception of complex interventions. We identified minor issues around wording of some items; universal issues around how to engage with people at different time points in an intervention; and conceptual issues around the types of people for whom the instrument should be designed. We managed these by adding extra items (n = 6) and including a new set of option responses: ‘not relevant at this stage’, ‘not relevant to my role’ and ‘not relevant to this intervention’ and decided to design an instrument explicitly for those people either delivering or receiving an intervention. This version of the instrument had 53 items. Twenty-three people with a good working knowledge of NPT reviewed the items for theoretical drift. Items that displayed a poor alignment with NPT sub-constructs were removed (n = 8) and others revised or combined (n = 6). The final instrument, with 43 items, was successfully piloted with five people, with a 100% completion rate of items.ConclusionThe process of moving through cycles of theoretical translation, item generation, cognitive testing, and theoretical (re)validation was essential for maintaining a balance between the theoretical integrity of the NPT concepts and the ease with which intended respondents could answer the questions. The final instrument could be easily understood and completed, while retaining theoretical validity. NoMAD represents a measure that can be used to understand implementation participants’ experiences. It is intended as a measure that can be used alongside instruments that measure other dimensions of implementation activity, such as implementation fidelity, adoption, and readiness.