Development and validation of a patient reported experience measure for experimental cancer medicines (PREM-ECM) and their carers (PREM-ECM-Carer).

BACKGROUND: Our aim was to develop a validated Patient Reported Experience Measure (PREM) to capture patient and carer experience during participation in experimental cancer medicine trials (ECM): called PREM-ECM. METHODS: Mixed method design, consisting of four stages. Questionnaire items were produced for both patients and carers using interviews, focus groups, and cognitive interviews with patients and carers separately. For both patient and carer PREMs, a cross-sectional questionnaire study was conducted to identify final items for inclusion using hierarchical item reduction and Rasch analysis. Questionnaire validity and reliability were assessed, including administration feasibility. RESULTS: Initial interview participants suggested the need for three PREMs, two specific to patients: (i) a 'prior' questionnaire that captured experiences of trial introduction, screening, consenting, and early trial experience (< 6 weeks post consent); and (ii) 'on-trial' that captured experiences of ongoing consent and trial participation; and (iii) a PREM specific for carers. The draft 25-item 'prior' questionnaire was completed by 162 patients and 162 patients completed the draft 35-item 'on-trial' questionnaire. Hierarchical and Rasch analysis produced a 14-item 'prior' list and a 15-item list for 'on-trial'. Both patient PREM's demonstrated a good fit to the Rasch model following Bonferroni correction (X2p = 0.008). The carer 34-draft item questionnaire was completed by 102 participants. Hierarchical and Rasch analysis produced a 13-item list for PREM-ECM-Carer, with good fit to the Rasch model ( X2p = 0.62). The pilot testing demonstrated the feasibility of all the PREMs in capturing patient and caregiver experiences in routine clinical settings. CONCLUSIONS: The three PREM-ECM questionnaires will be the first validated experience measures for ECM trial patients and their carers. These questionnaires may be used to assess patients' and their carers' experiences of ECM and enable robust comparisons across cancer trial units highlighting areas for service improvement.

Psychometric Evaluation of the Cancer Dependent Quality of Life (CancerDQoL) Questionnaire: An Individualised Measure of the Impact of Cancer and Its Treatment on Quality of Life.

OBJECTIVE: The Cancer Dependent Quality of Life (CancerDQoL) questionnaire asks about the impact of cancer and its treatment on individuals' quality of life (QoL). This study evaluates the psychometric properties of the CancerDQoL in a UK sample. METHODS: Patients (n = 159) with a range of cancers, recruited from Barts Health NHS Trust and Barts Maggie's Centre, completed self-administered questionnaires: CancerDQoL, EQ-5D-VAS (health status), EORTC-QLQ-C30 (predominantly health symptoms/functioning) and W-BQ16 (well-being). Based on the pre-existing -DQoL template and Item Library (Bradley), the CancerDQoL includes 23 cancer-specific life-domain items and four overview items. RESULTS: Exploratory factor analysis revealed a 22-item, single-factor solution. Internal consistency was excellent (α = 0.94). Cancer negatively impacted all life domains: 'feelings about future' had the most negative mean weighted (by importance) impact (WI) score. 'Physical abilities' WI scores were ranked 12th. CancerDQoL Average Weighted Impact (AWI) scores were more strongly correlated with the Cancer-dependent QoL overview item than with the General QoL or General Health overview items. As expected, the EQ-5D-VAS and EORTC-QLQ-C30 correlated together more strongly than with CancerDQoL AWI scores. CONCLUSIONS: The CancerDQoL is the first individualised questionnaire measuring the impact of cancer and its treatment on QoL. The CancerDQoL AWI score is related to, but different from, measures of health status/functioning and well-being. Eleven CancerDQoL life-domains were more negatively impacted/important than physical abilities which is a major focus of the EQ-5D and EORTC-QLQ-C30. By revealing aspects of life most impacted by cancer and its treatment, efforts can be prioritised to improve QoL for people with cancer.

Development and pilot testing of a patient-reported outcome measure to assess symptoms of parastomal hernia.

AIM: The aim was to develop and pilot a patient-reported outcome measure (PROM) to assess symptoms of parastomal hernia (PSH). METHODS: Standard questionnaire development was undertaken (phases 1-3). An initial list of questionnaire domains was identified from validated colorectal cancer PROMs and from semi-structured interviews with patients with a PSH and health professionals (phase 1). Domains were operationalized into items in a provisional questionnaire, and 'think-aloud' patient interviews explored face validity and acceptability (phase 2). The updated questionnaire was piloted in patients with a stoma who had undergone colorectal surgery and had a computed tomography scan available for review. Patient-reported symptoms were examined in relation to PSH (phase 3). Three sources determined PSH presence: (i) data about PSH presence recorded in hospital notes, (ii) independent expert review of the computed tomography scan and (iii) patient report of being informed of a PSH by a health professional. RESULTS: For phase 1, 169 and 127 domains were identified from 70 PROMs and 29 interviews respectively. In phase 2, 14 domains specific to PSH were identified and operationalized into questionnaire items. Think-aloud interviews led to three minor modifications. In phase 3, 44 completed questionnaires were obtained. Missing data were few: 5/660 items. PSH symptom scores associated with PSH presence varied between different data sources. The scale with the most consistent differences between PSH presence and absence and all data sources was the stoma appearance scale. CONCLUSION: A PROM to examine the symptoms of PSH has been developed from the literature and views of key informants. Although preliminary testing shows it to be understandable and acceptable it is uncertain if it is sensitive to PSH-specific symptoms and further psychometric testing is needed.

Development and Evaluation of a Patient Cirrhosis Knowledge Assessment.

BACKGROUND AND AIMS: Self-management skills improve outcomes for patients with cirrhosis. While education programs exist to teach these skills, there are limited patient assessments to evaluate their efficacy. We aimed to develop and evaluate cirrhosis knowledge assessments for patients with compensated and decompensated cirrhosis. METHODS: Across two institutions, a 4-stage process was undertaken: first, we developed a comprehensive set of questions regarding cirrhosis self-management. Second, the questions underwent critical review by patients and hepatology providers. Third, patients with cirrhosis answered these questions before and after a written educational tool. Questions were updated based on results. Fourth, patients answered the updated questions before and after a video educational tool. Binomial test or paired sample t-test was used to compare pre- and post-tests depending on question type. RESULTS: In phase 3, 134 patients completed pre- and post-tests. 44% were decompensated, 81% were diagnosed with cirrhosis at least 3 years, and 52% were 60-75 years. 95% of single-answer questions were answered correctly by at least 70% of patients in the pre-test. None of the answers improved significantly with education. After phase 3, 6 questions were removed and 6 questions were edited to increase challenge. In phase 4, 96 patients (42 compensated, 54 decompensated) completed pre- and post-tests. In the compensated assessment, 3 questions improved after education and the summative score increased (7.9 to 9.0, P < 0.001). In the decompensated assessment, 4 questions improved after education and the summative score increased (7.0 to 7.7, P = 0.004). CONCLUSION: Through a rigorous process, we created and evaluated cirrhosis knowledge assessments for patients with compensated and decompensated cirrhosis. Further validation is required and then these assessments can be used to improve patient education.

Development and preliminary validation of a questionnaire on the care needs of family carers of older individuals with disabilities in China: a mixed methods study.

BACKGROUND: Ensuring the wellness of older individuals with disabilities requires prioritising the care needs of their carers. However, current practice lacks validated tools to measure the needs of carers in home environments. Thus, this study aimed to create and test a questionnaire on the care needs of family carers of older people with disabilities in China. METHODS: We used a standard development process to generate the questionnaire. The pilot testing included cognitive interviews to ensure interpretation as intended. Furthermore, we used a cross-sectional study method to conveniently select 640 Chinese family carers of older people with disabilities from August 1, 2022, to June 11, 2023, for face-to-face investigation. Exploratory factor analysis (EFA) aided in project reduction and factor estimation, with 30 participants undergoing retest evaluations every two weeks. Confirmatory factor analysis (CFA) assessed the model's structural validity, while internal consistency and retest reliability validated its accuracy. RESULTS: These tests established the model: content validity, item analysis and EFA. Six factors extracted from the initial analysis explained 62.891% of the observation variance. CFA showed good model fit, and the questionnaire had good reliability and validity. The final questionnaire included 21 items focusing on six dimensions: care assistance (three items), care environment (three items), care information (three items), formal support (four items), care ability (six items) and self-development (two items). CONCLUSION: The care needs questionnaire effectively evaluates the needs of family carers in their caring activities.

Development, validation and feasibility of a Patient Satisfaction Questionnaire for evaluating the quality performance of a diagnostic small fibre neuropathy service: A qualitative study.

INTRODUCTION AND AIM: Small fibre neuropathy (SFN) is a peripheral neuropathy, leading to neuropathic pain and autonomic dysfunction. An evidence-based standardized patient diagnostic SFN service has been implemented in the Netherlands for improving patient-centred SFN care. However, the quality of care of this diagnostic SFN service has never been assessed from a patient perspective. The aim of this study was to develop and validate an SFN-Patient Satisfaction Questionnaire (SFN-PSQ) to measure the quality performance of a standardized diagnostic SFN service. METHODS: A descriptive qualitative study to create the SFN-PSQ was performed using the (COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist. For item generation and content development, domains and/or items from validated PSQs were selected. The content development and content validity were performed using a Delphi method with SFN expert caregivers with different backgrounds. By using the three-step-test method in individual cognitive interviews, the content validity by patients was finalized. RESULTS: In one online Delphi panel round, the content of the first concept of the SFN-PSQ was validated, which resulted in the second concept of the SFN-PSQ. From July 2019 till March 2020, nine patients consented to participate in the individual cognitive interviews. The most significant changes of the new questionnaire were adding domains and items concerning the waiting list, the diagnostic services and consultation by the hospital psychiatrist. Also, a differentiation was made for both an inpatient and outpatient diagnostic SFN service. Furthermore, the clarity and intelligibility of the domains/items were improved, resulting in an increased comprehension of the SFN-PSQ. Ultimately, the new developed SFN-PSQ consisted of 10 domains and 51 items, suitable for measuring patient satisfaction of the neurological analysis in patients with SFN. CONCLUSION: Through item generation, expert opinions and interviews with patients, the SFN-PSQ was developed and validated, and feasibility was confirmed. The structure of the questionnaire, based on the logistic and diagnostic SFN pathway, could be used as a model in other hospitals to improve the quality, continuity and access of SFN care and other chronic diseases taking into account potential cross-cultural differences. PATIENT OR PUBLIC CONTRIBUTION: Caregivers were involved in the item generation and content development of the questionnaire. Patients were directly involved in testing the content validity and feasibility of the SFN-PSQ. CLINICAL TRIAL REGISTRATION: Not applicable.

Development of an early intervention in psychosis services fidelity questionnaire.

PURPOSE: We describe the development of an online fidelity questionnaire for early intervention in psychosis (EIP) services, to be used in population-level research, and that can be completed using self-reports from EIP staff. METHODS: A review of key literature sources on the components of EIP services was used to identify those components eligible for inclusion in the questionnaire. A modified Delphi approach, using experts in EIP services, was used to select the most important components to include in the questionnaire. To pilot test the questionnaire, two EIP staff members completed one fidelity questionnaire each, and a third questionnaire was completed by an external rater. Responses from the three sources were compared and used to revise the fidelity questionnaire. RESULTS: Twenty-two experts from England and Canada responded to two Delphi rounds, identifying the top 25 most important EIP service components. Some evidence-based components were not rated as highly as some non-evidence-based components. Pilot testing showed that the EIP staff rated fidelity higher than the external rater. Several questions were removed and/or revised based on the pilot study findings. CONCLUSIONS: Fidelity instruments are limited by the available evidence and the personal experiences of experts used to develop them. As such, fidelity instruments and EIP services should continually be updated to reflect new knowledge. The online fidelity questionnaire was a simple and efficient way to collect data. Future evaluations of the fidelity questionnaire need to ensure that externally collected fidelity data are comprehensive and accurate.

"I find it hard to change poor food habits": Measuring food choice motives in an emerging economy.

Food choices are driven by an array of motives that have been approached, determined and quantified in a number of ways, mainly in developed countries. The objective of this study was to better understand the motives behind food choices in an emerging economy by collecting information from urban people in South Africa in a series of four studies. (1) Items generated through focus group discussions with low, middle and high income participants by Magano et al. (2023) were checked for content and face validity and (2) 123 statements derived from them were evaluated by 621 respondents. After exploratory factor analysis (EFA), 46 statements best representing the motivational space were (3) presented to another group of respondents (n = 259). Here, the EFA resulted in a 31-item, 7-factor food choice questionnaire for emerging economies (FCQ-EE) which was (4) confirmed by a nationwide sample (n = 814) and further refined to an alternative 19-item, 7-factor solution. The emerging factors were: Healthy eating constraints (HEC), Frugality (FR), Emotional eating (EE), Meat appeal (MA), Weather (WE), Quality seeking (QS) and Cooking constraints (CC). Whether used in the 31-item or 19-item format, this set of statements highlights factors underlying food choice in an emerging economy and offers a way to study their importance in similar contexts. Further research is needed to show the extent to which these factors can predict actual food choices.

Development of a self-report measure of empowerment along the hearing health journey: a content evaluation study.

OBJECTIVE: To conduct the first phases in the development of a self-report measure of empowerment on the hearing health journey, specifically, item generation and content evaluation of the initial pool of items generated. DESIGN: A content expert panel survey and cognitive interviews were conducted. Descriptive statistics were obtained for the quantitative data, and the cognitive interviews were analysed using thematic analysis. STUDY SAMPLE: Eleven researchers and clinicians participated in the content expert surveys. Sixteen experienced hearing aid users participated in the cognitive interviews, recruited from the USA and Australia. RESULTS: The items underwent five iterations based on feedback from the survey and interview data. This resulted in a set of 33 quality-tested potential survey items that were rated highly for relevance (mean = 3.96), clarity (mean = 3.70) and fit to dimensions of empowerment (mean = 3.92) (scale 0-4, where 4 was the maximum rating). CONCLUSIONS: Involving stakeholders in item generation and content evaluation increased relevance, clarity, fit to dimension, comprehensiveness, and acceptability of the items. This preliminary version of the 33-item measure underwent further psychometric refinement (Rasch analysis and traditional classical test theory testing) to validate it for clinical and research use (reported separately).

[An instrument to assess biopsychosocial pain concepts in adults : Development and evaluation by experts]. / Ein Instrument zur Erfassung biopsychosozialer Schmerzkonzepte von Erwachsenen : Entwicklung und Evaluation durch Expert*innen.

BACKGROUND: The biopsychosocial model is fundamental for the understanding and treatment of chronic pain; however, little research has focused on whether those affected show a biopsychosocial understanding. The multidimensional questionnaire Biopsychosocial Pain Concept Matrix (BiPS matrix) is presented. The conception of the BiPS matrix is based on the biological, psychological and social areas as well as on the common sense model of self-regulation with five dimensions: (1) type of disorder, (2) assumptions on the causes, (3) consequences, (4) duration of the disease and (5) possibilities for control and treatment. OBJECTIVE: The present study aims to examine the content relevance and comprehension of the areas, dimensions and items, including the use of the BiPS matrix with children by interdisciplinary expert ratings. The questionnaire can be perspectively used by treating professionals for diagnostic purposes. METHOD: In an online study 17 experts were questioned. In addition to descriptive statistics, comments were evaluated using qualitative content analysis according to Mayring. RESULTS: All experts rated the assessment of pain concepts with the BiPS matrix as well as the areas and dimensions as very relevant. With respect to the items, suggestions were made mainly regarding the wording of the items and adjustments for children. DISCUSSION: From an expert point of view the BiPS matrix represents a relevant instrument. Further research on the psychometric properties of the BiPS matrix in adults and children is indicated. In addition, the BiPS matrix can also be used to investigate pain concepts of medical and psychotherapeutic professional groups to demonstrate the biopsychosocial understanding of pain and the associated treatment options.

The mental health self-direction scale: An abridged version and its sensitivity to change.

OBJECTIVE: The Mental Health Self-Direction Scale (MHSD) measures the extent to which clients are able to resolve mental problems by themselves. Because this scale had not yet been evaluated, the aims of this paper were (a) to evaluate and improve the MHSD and (b) to explore the sensitivity to change of the improved scale. METHOD: The MHSD was evaluated and improved by means of confirmatory factor analyses of data from one longitudinal and two cross-sectional outpatient sample. Inconsistent items were removed in a stepwise fashion. Subsequently, the scale's sensitivity to change was explored in the longitudinal sample by using latent growth curve models. RESULTS: The original 31-item scale was reduced to a more stable version with 19 items that yielded four factors named: actorship, demoralization, commitment, and understanding. Throughout clients' treatment, actorship and understanding tended to increase; demoralization tended to decrease; and commitment remained consistently high. CONCLUSIONS: The abridged MHSD scale is stable and sensitive to change. It measures the extent to which clients experience and develop self-direction throughout their treatment. With the use of the new MHSD scale, new views on mental health that emphasize clients' ability to actively engage and cope with health-challenges can be incorporated into clinical treatment.

[Development of a German short version of the Nijmegen Cochlear Implant Questionnaire]. / Konstruktion einer Kurzversion des Nijmegen Cochlear Implant Questionnaire in deutscher Sprache.

BACKGROUND: The Nijmegen Cochlear Implant Questionnaire (NCIQ) is a questionnaire for assessing hearing-specific quality of life in the context of cochlear implantation. Its length (60 items) makes it difficult to use in clinical practice, so a short version is desirable. The question arises as to which items should be selected for the short version. METHODS: The items were selected statistically using uncorrected item-total score correlation. Item selection was made based on datasets from three measurement points: before implantation and 3 and 12 months after processor activation. The items were selected according to the criterion that they were among the 40 items with the highest item-total score correlation at each of the three measurement points. RESULTS: Of the 60 items in the NCIQ, 25 met the criterion and were hence included in the short version. The short version yields similar scores as the long version at the postoperative timepoints; however, at the preoperative timepoint, the agreement of the scores is suboptimal. Split-half reliability and internal homogeneity of the short version are very good. CONCLUSION: The present study constitutes an initial positive evaluation of a short form of the NCIQ in terms of standard psychometric criteria. Application of the short form is associated with significantly reduced resources in terms of processing and evaluating.

Environmental health knowledge of healthcare professionals: Instrument development and validation using the Rasch model.

INTRODUCTION: environmental risk factors constitute a major public health issue, calling for preventive actions and interventions at multiple levels. An important step in this direction is increasing the environmental health (EH) knowledge of the healthcare professionals. In this context, tools designed to measure such knowledge are of imperative importance. The aim of the present study was to develop an EH knowledge tool for healthcare professionals. METHODS: a group of experts defined the knowledge areas of the EH tool and their corresponding items. An online pilot and a validation study were performed. Internal consistency reliability was measured with the Kuder-Richardson 20 (KR-20) estimate, the construct validity and uni-dimensionality of the tool were assessed with the Rasch model. Known-groups validity was analysed with the two-sample t-test. RESULTS: a total of n = 151 and n = 444 healthcare professionals and end-year medical and nursing students, participated in the pilot and the validation study, respectively. The resulting 33-item EH knowledge questionnaire for healthcare professionals (EHKQ-HP) obtained a KR-20 = 0.82. The scale is uni-dimensional. Its construct validity was verified, and its items cover a wide range of difficulties. Separation statistics were adequate and known-groups behaved as hypothesized. CONCLUSIONS: the EHKQ-HP is a valuable resource for measuring the EH knowledge of the healthcare professionals. As such it will be useful in detecting EH knowledge gaps, and helping public health agents in making informed decisions when developing interventions for increasing this very knowledge. This would consequently help in improving the health of the general population.

The current use of the EORTC QLQ-NMIBC24 and QLQ-BLM30 questionnaires for the assessment of health-related quality of life in bladder cancer patients: a systematic review.

PURPOSE: Investigating the use of the EORTC bladder cancer (BC) modules by evaluating: (a) study contexts/designs; (b) languages/countries in which the modules were administered; (c) their acceptance by patients/investigators; and (d) their psychometric properties. METHODS: A systematic review was performed with studies from 1998 until 20/10/2021 in five databases. Articles/conference abstracts using the EORTC-QLQBLM30 (muscle invasive BC) and the EORTC-QLQNMIBC24 (previously referred to as QLQ-BLS24; non-muscle invasive BC) were included. Two authors independently screened titles/abstracts/full-texts and performed data extraction. RESULTS: A total of 76 eligible studies were identified. Most studies included the BLM30 (n = 53), were in a urological surgery context (n = 41) and were cross-sectional (n = 35) or prospective (n = 30) in design. The BC modules were administered in 14 languages across 19 countries. Missing data were low-moderate for all non-sex related questions (< 1% to 15%). Sex-related questions had higher rates of missing data (ranging from 6.9% to 84%). Most investigators did not use all scales of the questionnaires. One validation study for the original BLS24 led to the development of the NMIBC24, which adopted a new scale structure for which good structural validity was confirmed (n = 3). Good reliability and validity was shown for the NMIBC24 module, except for malaise and bloating/flatulence scales. Psychometric evidence for BLM30 is lacking. CONCLUSION: These results provide insight into how the EORTC BC quality of life modules could be further improved. Current work is ongoing to update the modules and to determine if the two modules can be combined into a single questionnaire that works well in both the NMIBC and MIBC settings.

Content validation of a daily patient-reported outcome measure for assessing symptoms in patients with Small Intestinal Bacterial Overgrowth.

PURPOSE: The aim of this study was to generate evidence supporting the development and content validity of a new PRO instrument, the Small Intestinal Bacterial Overgrowth (SIBO) Symptom Measure (SSM) daily diary. The SSM assesses symptom severity in SIBO patients, with the ultimate goal of providing a fit for purpose PRO for endpoint measurement. METHODS: Qualitative research included 35 SIBO patients in three study stages, using a hybrid concept elicitation (CE)/cognitive interview (CI) method with US patients, ≥ 18 years. Stage 1 included a literature review, clinician interviews, and initial CE interviews with SIBO patients to identify symptoms important to patients for inclusion in the SSM. Stage 2 included hybrid CE/CI to learn more about patients' SIBO experience and test the draft SSM. Finally, stage 3 used CIs to refine the instrument and test its content validity. RESULTS: In stage 1 (n = 8), 15 relevant concepts were identified, with items drafted based on the literature review/clinician interviews and elicitation work. Within stage 2 (n = 15), the SSM was refined to include 11 items; with wording revised for three items. Stage 3 (n = 12) confirmed the comprehensiveness of the SSM, as well as appropriateness of the item wording, recall period, and response scale. The resulting 11-item SSM assesses the severity of bloating, abdominal distention, abdominal discomfort, abdominal pain, flatulence, physical tiredness, nausea, diarrhea, constipation, appetite loss, and belching. CONCLUSIONS: This study provides evidence supporting the content validity of the new PRO. Comprehensive patient input ensures that the SSM is a well-defined measure of SIBO, ready for psychometric validation studies.

"Recognition of heart attack symptoms and treatment-seeking behaviors: a multi-center survey in Tehran, Iran".

BACKGROUND: In acute myocardial infarction (AMI), timely recognition of symptoms and early hospital presentation positively affect patient morbidity and mortality. Due to the high burden of ischemic heart disease in Iran, this study aimed to identify factors affecting the level of knowledge, responses at the time of AMI onset, and sources of health information among the Iranian population. METHOD: This cross-sectional study was conducted in three tertiary hospitals in Tehran, Iran. An expert-validated questionnaire was used to obtain data. A total of 400 individuals were enrolled. RESULT: Among the respondents, 285 people(71.3%) considered "chest pain or discomfort," and 251 (62.7%) regarded "pain or discomfort in the arm or shoulder" as MI symptoms. Approximately 288 (72.0%) respondents had poor knowledge of the AMI symptoms. Knowledge of symptoms was higher among those with higher levels of education, those with medical-associated jobs, and those who resided in the capital areas. Major risk factors identified by the participants were: anxiety (340)(85.0%), obesity (327)(81.8%), an unhealthy diet (325)(81.3%), and the presence of high LDL levels (258)(64.5%) and Diabetes Mellitus (164)(41.0%) were less appreciated. Calling an ambulance (286)(71.5%) was the most common treatment-seeking behavior in the case of a suspected heart attack. CONCLUSION: It is vital to educate the general population about AMI symptoms, particularly those with comorbidities at the greatest risk for an AMI episode.

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

BACKGROUND: Bespoke self-report resource-use measures (RUMs) are commonly developed or adapted for each new randomised controlled trial. Consequently, RUMs lack standardisation and validation is rarely conducted. A new generic RUM, ModRUM, has been developed using a rigorous process, including consultation with health economists and patients. ModRUM includes a concise core healthcare module, designed to be included in all trials, and depth-adding questions, which can replace or be added to core questions as needed. Modules covering other sectors are under development. The aim of this study was to test the acceptability, feasibility, and criterion and construct validity of the healthcare module of ModRUM. METHODS: Patients who had a recent appointment at their GP practice were invited to complete ModRUM (core module or core module with depth questions), a characteristics form and the EQ-5D-5L. Acceptability was assessed via response rates and questionnaire completion time. Feasibility was assessed by reviewing issues observed in participants' responses and question completion rates. Construct validity was tested via hypothesis testing and known-group analyses, using Wilcoxon rank-sum and Kruskal-Wallis tests, and a generalised linear model. Criterion validity was tested by comparing ModRUM results with primary care medical records. Sensitivity, specificity, and agreement using Lin's concordance correlation coefficient (pc) were estimated. RESULTS: One hundred patients participated from five GP practices in the South-West of England. Acceptability was higher for the core module (20% versus 10% response rate). Question completion rates were high across both versions (> 90%). Some support was observed for construct validity, with results suggesting that healthcare costs differ dependent on the number of long-term conditions (p < 0.05) and are negatively associated with health-related quality of life (p < 0.01). Sensitivity was high for all questions (> 0.83), while specificity varied (0.33-0.88). There was a good level of agreement for GP contacts and costs, and prescribed medication costs (pc > 0.6). CONCLUSION: This study provided preliminary evidence of the acceptability, feasibility, and criterion and construct validity of ModRUM. Further testing is required within trials and with groups that were less well represented in this study.

Development and validation of a tool to assess researchers' knowledge of human subjects' rights and their attitudes toward research ethics education in Saudi Arabia.

BACKGROUND: Researchers must adhere to ethical and scientific standards in their research involving human subjects; therefore, their knowledge of human subjects' rights is essential. A tool to measure the extent of this knowledge is necessary to ensure that studies with participants are conducted ethically and to enhance research integrity. Currently, no validated instrument is available for such an assessment. Therefore, the primary purpose of this study is to develop a reliable and valid instrument to assess researchers' knowledge of human subjects' rights in clinical settings, as well as a reliable and valid measure of their attitudes toward clinical research ethics education in Saudi Arabia. METHODS: The current study involves the development of a questionnaire about the rights of human subjects in research and the researchers' attitudes toward research ethics education. The content was developed based on an extensive review of research ethics guidelines. A panel of experts tested the questionnaire for face validity (n = 5) and content validity (n = 8). The reliability of the questionnaire was established by a split-half reliability coefficient and item analysis among a sample (n = 301) of clinical researchers. RESULTS: Face validity demonstrated that the questionnaire was quick to complete and easy to answer. The global content validity indices (S-CVIs) were greater than 0.78 for all questionnaire sections; the split-half reliability coefficient was 0.755 for knowledge items; Cronbach's alpha was 0.77 for researchers' attitudes, showing good internal consistency. The difficulty index ranged from 12.0% to 98.7% for all knowledge items. Most questions were at an acceptable level of reliability and discrimination criteria. The final version of the questionnaire contained 89 items, distributed as 15 questions on demographic and professional characteristics, 64 questions items on knowledge, and 10 items on attitudes. CONCLUSIONS: The questionnaire is a valid and reliable tool to assess biomedical researchers' knowledge of human subjects' rights and their attitudes toward research ethics education. This instrument could help address the gap in researchers' knowledge of the rights and facilitate the development of educational intervention programs to set appropriate learning objectives.

Development and validation of the Health Literacy Scale for community-dwelling older adults in Taiwan.

Health literacy is a crucial factor in determining one's health outcomes. Individuals with high health literacy possess the ability to access, comprehend, evaluate, and utilize health information to maintain, enhance, and advocate for good health. This study aimed to develop and validate a tool called the Health Literacy Questionnaire for Older Adults (HLQ-OA) specifically designed to assess the health literacy of community-dwelling older adults in Taiwan. The development of the HLQ-OA occurred in two phases. Firstly, a systematic literature review was conducted, followed by the evaluation of content validity and face validity through expert and older adult assessments. Subsequently, a cross-sectional study was carried out, involving a convenient sample of 481 older adults from community-dwelling long-term care stations. The final version of the HLQ-OA comprised 16 items that assessed four competencies associated with accessing, understanding, appraising, and applying health-related information. The HLQ-OA demonstrated excellent internal consistency, with an overall Cronbach's α coefficient of 0.94. Additionally, the model fit indices indicated an acceptable fit: RMSEA = 0.046, GFI = 0.909, CFI = 0.945, TLI = 0.939. Furthermore, a high correlation was observed between the HLQ-OA and the HL-SF12 (r = 0.832). These findings support the reliability and validity of the HLQ-OA as a tool for assessing the health literacy of older adults. In conclusion, the HLQ-OA is a reliable and valid instrument that can be effectively utilized to measure the health literacy levels of older adults.

Evaluation of the simulation based training quality assurance tool (SBT-QA10) as a measure of learners' perceptions during the action phase of simulation.

BACKGROUND: In an earlier interview-based study the authors identified that learners experience one or more of eight explicit perceptual responses during the active phase of simulation-based training (SBT) comprising a sense: of belonging to instructor and group, of being under surveillance, of having autonomy and responsibility for patient management, of realism, of an understanding of the scenario in context, of conscious mental effort, of control of attention, and of engagement with task. These were adapted into a ten-item questionnaire: the Simulation Based Training Quality Assurance Tool (SBT-QA10) to allow monitoring of modifiable factors that may impact upon learners' experiences. This study assessed the construct validity evidence of the interpretation of the results when using SBT-QAT10. MATERIALS AND METHODS: Recently graduated doctors and nurses participating in a SBT course on the topic of the deteriorating patient completed the SBT-QAT10 immediately following their participation in the scenarios. The primary outcome measure was internal consistency of the questionnaire items and their correlation to learners' satisfaction scores. A secondary outcome measure compared the impact of allocation to active versus observer role. RESULTS: A total of 349 questionnaires were returned by 96 course learners. The median of the total score for the ten perception items (TPS) was 39 (out of 50), with no significant difference between the scenarios. We identified fair and positive correlations between nine of the 10 items and the SBT-QA10-TPS, the exception being "mental effort". Compared to observers, active learners reported significantly more positive perceptions related to belonging to the team and interaction with the instructor, their sense of acting independently, and being focused. The questionnaire items were poorly correlated with the two measures of global satisfaction. CONCLUSION: Except for the item for mental effort, the QA10-TPS measures learners' experiences during the active phase of simulation scenarios that are associated with a positive learning experience. The tool may have utility to learners, instructors, and course providers by informing subsequent debriefing and reflection upon practice for learners and faculty. The relationship between these perceptions and commonly used measures of satisfaction remains poorly understood raising questions about the value of the latter.