Assess Content Validity Research Articles

Designing a tool for measuring determinants of eye self-care and evaluating its psychometric properties.

Eye care is crucial for maintaining healthy vision. This study aimed to design a determinants assessment instrument related to eye self-care in the student community and evaluate its psychometric properties. The present mixed-method cross-sectional study was conducted in two sections using Creswell and Plano Clark methods for instrument development. The study was conducted in Isfahan, Iran, in 2021. The first section (textual analysis and qualitative research) explained and developed the instrument's fundamental items. This section included in-depth, semi-structured interviews with 21 students and eight experts. In the second, the psychometric properties of the designed instrument have been evaluated. Twenty students assessed the instrument's qualitative and quantitative face validity. The instrument's content was measured by computing the content validity ratio and content validity index. In addition, exploratory factor analysis (performed on 251 students) was used to establish construct validity. Internal and test-retest reliability was determined using Cronbach's alpha and intraclass correlation coefficients (ICC), respectively. During face and content validity assessment, a 39-item questionnaire was finalized. Exploratory factor analysis led to the extraction of seven factors, including "perceived self-efficacy and self-regulation," "outcome expectation," "perceived barriers," "motivation," "perceived susceptibility," "normative beliefs," and "perceived severity." The seven extracted factors explained 48.6% of the total variance. Cronbach's alpha was obtained to be 0.780, indicating good internal consistency, and the ICC for the total score of the questionnaire was 0.892 (95% confidence interval: 0.822-0.944), indicating excellent test-retest reliability. Our developed questionnaire was a valid and reliable instrument for assessing eye care determinants among students, a vulnerable population afflicted with eye defects and disorders.

Postpartum family planning attitudes among Turkish women: development of a reliable and valid scale.

The aim of this study was to develop a scale based on the Health Belief Model (HBM) to assess the family planning (FP) attitudes of postpartum women with 0- to 12-month-old infants residing in eight neighbourhoods of the Bornova province, Izmir, Turkey. Family planning is an integral component of maternal and infant health during the postpartum period and is a fundamental aspect of healthcare services in the prenatal and postnatal period. The Postpartum Family Planning Attitude Scale (PFPAS) was developed in four stages: item pool development, content validity evaluation, pilot study, and reliability and validity assessment. The PFPAS was administered to 292 women. The developed scale comprised 27 items and six sub-dimensions. Cronbach's alpha coefficient was used to evaluate the reliability of the scale. Construct validity was evaluated using confirmatory factor analysis. Cronbach's alpha coefficient was 0.88, indicating good reliability. Confirmatory factor analysis validated the structural validity of the scale, with a chi-square/degree of freedom ratio of 2.24, an RMSEA value of 0.068, and a CFI value of 0.95. The lowest and highest possible scores for the PFPAS were 27 and 135, respectively, with a mean total score of 105.32 ± 11.91.

Involving patients in the process: Development of a constipation patient-reported outcome measure for symptoms and quality of life

ObjectivePatient-reported outcome measures (PROMs) are useful standardized tools to measure current patient health status and well-being. While there are existing constipation-related PROMs, the majority of PROMs were not developed with adequate patient involvement and few examined content validity. Accordingly, the current study aimed to develop a constipation PROM with multiple phases of patient and clinician involvement. MethodsTo generate PROM items, 15 patients with chronic constipation (age range =28–79 years, 10 females) underwent a qualitative interview exploring their experiences with chronic constipation. Following that, eight clinical experts completed the content validity index (CVI) ratings of all the items generated to assess content validity. Based on results of the content validity assessment, relevant items were maintained and 12 participants with chronic constipation were re-interviewed to obtain feedback about comprehensibility, comprehensiveness and relevance. ResultsSix themes and 25 sub-themes emerged from the qualitative interview, and an initial list of 33 symptom items and 18 quality of life (QoL) items were generated. Based on the CVIs calculated, 11 symptom items and nine QoL items were maintained with the scale-content validity index indicating excellent content validity. Overall, participants indicated the PROM to be relevant, comprehensive and easy to understand however, minor amendments were made to improve the three qualities of interest. ConclusionThe current study developed a constipation PROM that measures both symptom severity and constipation-related QoL, with supporting evidence for relevance, comprehensiveness and comprehensibility. Further prioritization should be given to validating and exploring new digital modalities of PROM administration.

TRADUÇÃO E ADAPTAÇÃO TRANSCULTURAL DA FERRAMENTA KNOWLEDGE TRANSLATION PLANNING TEMPLATE PARA O CONTEXTO BRASILEIRO

ABSTRACT Objective: to translate, cross-culturally adapt, and validate the content of the Knowledge Translation Planning Template, a research dissemination planning tool, into Brazilian Portuguese. Method: this is a methodological study, sequentially divided into six stages: initial translation, translation synthesis, back-translation, judges' committee, pre-test, and approval of the adapted version by the instrument author. The judge's committee assessed content validity using the modified Kappa and Content Validity Index. The test was conducted with teachers and students from a Federal University of Santa Catarina graduate program. Results: the process of translating and back-translating the tool showed no discrepancies in terms of meaning. The committee was composed of seven judges who carried out semantic, cultural, and conceptual evaluations and made notes on the translation of the content. At this stage, the content validity showed excellent values for the Content Validity Index and modified Kappa, with 0.99 and 0.816, respectively. The tool was tested with 30 teachers and postgraduate students, where 90% of the respondents considered the tool to be sufficiently comprehensive and that all the items were relevant to the purpose of the instrument. In the last stage, the documents were analyzed together with the author of the original tool and the final version was approved. Conclusion: the Modelo de Planejamento de Tradução do Conhecimento results from a careful translation process, cross-cultural adaptation, and tool content validation. This has resulted in a tool that is applicable and understood by the target audience, which shows consistency in the equivalence of translation and cross-cultural adaptation for Brazil.

Psychometric properties of the Persian version of emotions and attitudes towards MRI" (MRI-EMA).

Patients with multiple sclerosis (MS) should have magnetic resonance imaging evaluation regularly. They will experience anxiety before this examination. We conducted this study to evaluate the validity and reliability of emotions and attitudes towards MRI" (MRI-EMA). One hundred-nine patients with MS were asked to fill the valid and reliable Persian version of Beck Anxiety Inventory (BAI), and MRI-EMA, questionnaires. Two weeks later, twenty cases were asked to fill the questionnaire again to assess reliability. The intra-class correlation coefficient (ICC) and Cronbach's alpha analysis were used. The correlation coefficient between BAI and MRI-EMA was calculated. Five neurologists assessed content validity by content validity ratio (CVR) and content validity index (CVI). The mean age was 37.2±1.2 years and 77% were females. CVI and CVR for all questions were 100%. The correlation coefficient between BAI and MRI-EMA was r=0.1, P=0.1 and only fear of MRI subscale was significantly correlated with BAI. The ICC of all questions was between 0.79 and 0.98. Patients with MS have to be routinely screened with MRI which provides anxiety for them. Considering MRI related anxiety is crucial for these cases. The Persian version of the MRI-EMA questionnaire is a valid and reliable instrument for measuring MRI related anxiety in patients with multiple sclerosis.

Cross-cultural adaptation, content validity and analysis of items of the Objective and Subjective Knowledge and HIV Testing Scale for the Brazilian population.

The objective was to propose a Portuguese version of the Objective and Subjective Knowledge and HIV Testing Scale (OSK-HIV-TS), to assess content validity and to perform analysis of items when applied to a sample of undergraduate students. Three translators translated the OSK-HIV-TS into Portuguese. Judges evaluated each item of the consensual version of the translated instrument according to semantic, idiomatic, cultural, and conceptual equivalences. A consensus committee reviewed the back-translated and original versions of the OSK-HIV-TS. Content validity was calculated by content validity index and analysis of items conducted using Classical Test Theory (CTT). The translated scale presented semantic, idiomatic, conceptual, and cultural equivalence in relation to the original version. A total of 491 undergraduate students participated and a high proportion of right answers was observed on the distribution of students' responses to the OSK-HIV-TS. All items were classified as easy or very easy and only the item 16 was classified as strong according to discrimination index. The OSK-HIV-TS is a novel instrument for assessing HIV knowledge in Brazilian literature that can inspire more research on HIV/AIDS behavior and associated factors, which, despite being essential and necessary, are still lacking in the Brazilian literature.

Math self-regulated learning assisted by metacognitive support by reviewing sex differences in mathematics anxiety

The study aims to analyze the effect of mathematics self-regulated learning (MSRL) assisted by metacognitive support (MS) by reviewing sex differences (SD) in mathematics anxiety (MA). The reason is that MA causes students to have difficulty in learning, so good strategies and approaches are needed. In several studies, there is a relevant relationship between MA, SRL, and MS. This research is quantitative research using Spearman Rho analysis and ordinal regression analysis, with the research population being 3rd-grade students of primary schools in Sidoarjo, East Java. The instruments used in data collection were questionnaires and tests declared valid and reliable. The validity and reliability of the instrument were obtained through content validity assessment and item analysis testing. The results showed a relationship between SRL and MS to MA. There was a positive effect of MS-assisted MSRL in terms of SD on MA. Furthermore, the average student had a positive MS and a high MSRL. The highest MA students are at the moderate level, with a percentage of 79%, and are dominant in the affective aspect. However, when viewed from the SD, the MA showed that female students were more anxious than male students. Thus, the MS-assisted SRL has a good influence when viewed from SD to MA. The recommendation from this research is so that MS and SRL strategies can be implemented optimally. Teachers must prepare and explore the implementation of using the strategies and approach more deeply.

VALIDATION OF A TOOL TO MEASURE THE LEVEL OF SCHOOL-UNIVERSITY PARTNERSHIP

This study aims at developing and validating an audit tool that could be used to assess school-university partnerships. Specifically, the study followed four steps of (i) evaluating and modifying contents and items of the original tool, (ii) qualitatively assessing content validity of the revised scale basing on expert ratings, and revising the scale accordingly, (iii) conducting cognitive interviews with potential participants, and making further revision, and (iv) quantitatively evaluating the validity and reliability of the audit tool based on data collected from 463 participants, and finalizing the tool. In the end, an audit tool consisting of 36 questions that fit into two scales (i.e., “Shared goals and values” and “Partnership operations and management”) was confirmed. The study also discussed potential uses of the tool for both currently working partnerships and newly formed partnerships; and at different levels.

What matters and influence resuscitation preference? Development, field testing, and structural validation of items among older patients in the emergency department

BackgroundDecisions about resuscitation preference is an essential part of patient-centered care but a prerequisite is having an idea about which questions to ask and understand how such questions may be clustered in dimensions. The European Resuscitation Council Guidelines 2021 encourages resuscitation shared decision making in emergency care treatment plans and needs and experiences of people approaching end-of-life have been characterized within the physical, psychological, social, and spiritual dimensions. We aimed to develop, test, and validate the dimensionality of items that may influence resuscitation preference in older Emergency Department (ED) patients.MethodsA 36-item questionnaire was designed based on qualitative interviews exploring what matters and what may influence resuscitation preference and existing literature. Items were organized in physical, psychological, social, and spiritual dimensions. Initial pilot-testing to assess content validity included ten older community-dwelling persons. Field-testing, confirmatory factor analysis and post-hoc bifactor analysis was performed on 269 older ED patients. Several model fit indexes and reliability coefficients (explained common variance (ECV) and omega values) were computed to evaluate structural validity, dimensionality, and model-based reliability.ResultsItems were reduced from 36 to 26 in field testing. Items concerning religious beliefs from the spiritual dimension were misunderstood and deemed unimportant by older ED patients. Remaining items concerned physical functioning in daily living, coping, self-control in life, optimism, overall mood, quality of life and social participation in life. Confirmatory factor analysis displayed poor fit, whereas post-hoc bifactor analysis displayed satisfactory goodness of fit (χ2 =562.335 (p<0.001); root mean square error of approximation=0.063 (90% CI [0.055;0.070])). The self-assessed independence may be the bifactor explaining what matters to older ED patients’ resuscitation preference.ConclusionsWe developed a questionnaire and investigated the dimensionality of what matters and may influence resuscitation preference among older ED patients. We could not confirm a spiritual dimension. Also, in bifactor analysis the expected dimensions were overruled by an overall explanatory general factor suggesting independence to be of particular importance for clinicians practicing resuscitation discussions in EDs. Studies to investigate how independence may relate to patients’ choice of resuscitation preference are needed.

Content Validation of the Movement Disorder-Childhood Rating Scale (MD-CRS) for Dyskinetic Cerebral Palsy

BackgroundDyskinetic cerebral palsy (DCP), a lifelong neurological disorder beginning in early childhood, manifests with hyperkinetic movements and dystonia. The Movement Disorder-Childhood Rating Scale (MD-CRS) is a clinician-reported outcome measure assessing the intensity of movement disorders and their effect on daily life in pediatric patients. Content validity of clinical outcome assessments is key to accurately capturing patient perspective. Evidence demonstrating content validity of the MD-CRS in patients with DCP is needed. This study captures input from patients with DCP and their caregivers regarding the content validity of the MD-CRS. MethodsThis qualitative, noninterventional, cross-sectional study included interviews with children/adolescents (aged six to 18 years) with DCP and caregivers of children with DCP. Participants were asked to describe body regions and daily functions affected by DCP. Caregivers also reviewed MD-CRS Part I to evaluate the relevance of the items and corresponding response options. Descriptions of DCP were coded and mapped to MD-CRS items and response options. Caregiver feedback on MD-CRS Part I was analyzed using inductive content analysis. ResultsEight patients and 12 caregivers were interviewed. Participants confirmed that the body regions and activities listed in the MD-CRS were affected by DCP and that involuntary movements interfered with all motor, oral/verbal, self-care, and video protocol activities. Caregivers endorsed the response options for 12 of 15 items in MD-CRS Part I and suggested clarifications for others. ConclusionsParticipants confirmed that affected body regions and activities listed in the MD-CRS were relevant to their experience with DCP, demonstrating the content validity of this tool in children/adolescents with DCP.

Monitoring independence in daily life activities after trauma in humanitarian settings: Item reduction and assessment of content validity of the Activity Independence Measure-Trauma (AIM-T).

A standardized set of measures to assess functioning after trauma in humanitarian settings has been called for. The Activity Independence Measure for Trauma (AIM-T) is a clinician-rated measure of independence in 20 daily activities among patients after trauma. Designed in Afghanistan, it has since been used in other contexts. Before recommending the AIM-T for wider use, its measurement properties required confirmation. This study aims at item reduction followed by content validity assessment of the AIM-T. Using a two-step revision process, first, routinely collected data from 635 patients at five facilities managing patients after trauma in Haiti, Burundi, Yemen, and Iraq were used for item reduction. This was performed by analyzing inter-item redundancy and distribution of the first version of the AIM-T (AIM-T1) item scores, resulting in a shortened version (AIM-T2). Second, content validity of the AIM-T2 was assessed by item content validity indices (I-CVI, 0-1) based on structured interviews with 23 health care professionals and 60 patients in Haiti, Burundi, and Iraq. Through the analyses, nine pairs of redundant items (r≥0.90) were identified in the AIM-T1, leading to the removal of nine items, and resulting in AIM-T2. All remaining items were judged highly relevant, appropriate, clear, feasible and representative by most of participants (I-CVI>0.5). Ten items with I-CVI 0.5-0.85 were revised to improve their cultural relevance or appropriateness and one item was added, resulting in the AIM-T3. In conclusion, the proposed 12-item AIM-T3 is overall relevant, clear, and representative of independence in daily activity after trauma and it includes items appropriate and feasible to be observed by clinicians across different humanitarian settings. While some additional measurement properties remain to be evaluated, the present version already has the potential to serve as a routine measure to assess patients after trauma in humanitarian settings.

Artificial intelligence-enhanced care pathway planning and scheduling system: content validity assessment of required functionalities

BackgroundArtificial intelligence (AI) and machine learning are transforming the optimization of clinical and patient workflows in healthcare. There is a need for research to specify clinical requirements for AI-enhanced care pathway planning and scheduling systems to improve human–AI interaction in machine learning applications. The aim of this study was to assess content validity and prioritize the most relevant functionalities of an AI-enhanced care pathway planning and scheduling system.MethodsA prospective content validity assessment was conducted in five university hospitals in three different countries using an electronic survey. The content of the survey was formed from clinical requirements, which were formulated into generic statements of required AI functionalities. The relevancy of each statement was evaluated using a content validity index. In addition, weighted ranking points were calculated to prioritize the most relevant functionalities of an AI-enhanced care pathway planning and scheduling system.ResultsA total of 50 responses were received from clinical professionals from three European countries. An item-level content validity index ranged from 0.42 to 0.96. 45% of the generic statements were considered good. The highest ranked functionalities for an AI-enhanced care pathway planning and scheduling system were related to risk assessment, patient profiling, and resources. The highest ranked functionalities for the user interface were related to the explainability of machine learning models.ConclusionThis study provided a comprehensive list of functionalities that can be used to design future AI-enhanced solutions and evaluate the designed solutions against requirements. The relevance of statements concerning the AI functionalities were considered somewhat relevant, which might be due to the low level or organizational readiness for AI in healthcare.

An integrated STEM-based mathematical problem-solving test: Developing and reporting psychometric evidence

Science, technology, engineering, and mathematics (STEM) problem-solving is necessary to be infused into the classroom. Nevertheless, the criticism of underrepresented mathematics in STEM problem-solving assessment is an issue. In this study, we develop and investigate the psychometric evidence of an integrated STEM-based mathematical problem-solving test. The product of the test was a mathematical essay test that contains three scientific scenarios related to the environment in every middle school grade. The mathematical contents were integrated into engineering-based design using the technology. Three experts filled an assessment sheet to assess content validity, which was analyzed using a content validity index (CVI) and intraclass correlation coefficient (ICC). The result of content validity revealed that overall items were valid and reliable. The construct validity was examined using the Rasch analysis from the data of Grades 7–9 students in Indonesia (n = 286). The construct of all scenarios and prompting items indicated fit with various difficulty levels and acceptable discrimination value. Nevertheless, four prompting items were reported as misfit based on unweighted mean square value. The recommendation for improvement is emphasized in the language clarity aspect. The inter-rater reliability was also declared good. A further study is suggested to provide a computer-based test.

Content Validity of the Left Ventricular Assist Device Bathing Assessment.

Many institutions recommend modified bathing techniques for individuals with left ventricular assist devices (LVADs) due to infection risk. Although these techniques may be challenging for patients, there currently is no assessment to evaluate these skills and whether intervention programs have been successful. This article describes the development and content validation of the LVAD Bathing Assessment. The content validity index (CVI) process was used to determine the relevance of assessment items. Modified Kappa indices were calculated to account for the possibility of chance agreement among raters. Eight content validity experts rated each assessment item and provided feedback. The overall assessment and 44 of 47 individual items had excellent content validity (scale-level CVI [S-CVI] = 0.97; item-level CVI [I-CVI] > 0.78). Minor revisions were made based on feedback. Creation of an LVAD bathing assessment may improve care by identifying safety risks that may cause infection. Further studies for construct validation and reliability testing are needed.

Translation and Psychometric Testing of the Norwegian Version of the “Patients’ Perspectives of Surgical Safety Questionnaire”

PurposeTo translate the Patients’ Perspectives of Surgical Safety (PPSS) questionnaire into Norwegian and to test it for structural validity and internal consistency. DesignThis is a methodological study. MethodsThe original 20-item PPSS questionnaire was translated into Norwegian using a model of translation-back translation. We assessed content validity via a pretest with 20 surgical patients. A sample of 218 surgical patients in a university hospital in Norway completed the PPSS questionnaire. Psychometric analysis included item characteristics, and structural validity was evaluated by an exploratory factor analysis. Internal consistency was calculated using Cronbach's alpha. FindingsWe successfully translated and adapted the Norwegian PPSS questionnaire. Completion rate was 74%. Missing values were less than 5% and all 20 items had a high skewness (≥15 %) ranging from 52.8% to 95.9%. The exploratory factor analysis yielded two significant factors that explained 45.15% of variance. The Cronbach's alpha for Factor 1 “Team interaction safety” was 0.88 and for Factor 2 “Patient's ID safety”, 0.82. Overall, most patients reported a high sense of surgical safety. ConclusionsThe first Norwegian version of the PPSS measuring surgical patients’ perception shows promising psychometric properties regarding structural validity and internal consistency. However, future research on PPSS should provide an examination of construct validity, validation and testing in other populations of surgical patients. To improve safety of the surgical trajectory, it is necessary to pay more attention to patients’ perceptions of surgical safety.

S96 An Exploration of the Experience and Measurement of Fatigue in Adults With Crohn’s Disease

Background: Fatigue has a detrimental impact on health-related quality of life and functioning in patients with Crohn’s disease (CD). We aimed to confirm the relevance and importance of fatigue, establish the content validity of the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), qualitatively explore meaningful change in fatigue experience, and assess the measurement properties of the FACIT-F in patients with moderate-to-severe CD. Methods: This was a mixed-methods observational study consisting of a cross-sectional qualitative interview (Part A) and a longitudinal 2-week daily diary pilot study (Part B) in participants aged ≥18 years with a clinical diagnosis of moderate-to-severe CD. Part A included open-ended questions related to the participant’s overall experiences with CD, fatigue, and impact on daily activities and a cognitive debriefing of several patient-reported outcomes (PROs), including the FACIT-F. Part B consisted of participants completing an electronic daily diary that included the FACIT-F and other PROs for 14 days. Item performance, test-retest reliability, and construct validity were assessed at baseline (Day 1), Day 7, and Day 14. Results: In Part A, thirty-five participants (mean age 45.1 years; 65.7% female) completed an interview. Ninety-one percent of the interview participants reported fatigue as a symptom attributed to CD. Participants indicated that fatigue had a major impact on their daily activities (e.g., recreation/ hobbies, work/school, yard work and housework), social activities, and emotional health. The FACIT-F was well understood by the interview participants. In Part B, seventy-6 participants (mean age 41.9 years; 66% female) completed at least the Day 1 diary entry. Potential floor and ceiling effects were observed for several FACIT-F items, but test-retest reliability and construct validity were all strong and within the ranges hypothesized a priori. Conclusion(s): The interviews indicate that fatigue is a frequent and bothersome symptom experienced by most patients with moderate-to-severe CD and support the content validity of the FACIT-F in this population. Daily diary study results indicate that the FACIT-F scale demonstrates adequate reliability and validity among patients with CD. These study findings suggest that the FACIT-F would be a reliable, valid, and useful measure of fatigue in patients with moderate-to-severe CD.

Erotic capital and its role in the assessment of candidates and employees: scale development and validation

Inspired by the concept of erotic capital, we claim that candidates’ and employees’ erotic capital is one of the factors that may influence on the decisions related to human resources management. Hakim’s concept is however criticized for being too extensive, too incoherent and lacking empirical studies to support it. Therefore, we have conducted empirical studies. They aimed at validating the construct of erotic capital in the context of its role in the assessment of another person, assessment that is intrinsic to HR decision-making. An additional goal was to develop a tool (questionnaire) for estimating the impact of the candidate's/employee's erotic capital on decisions being made concerning recruitment and appraisal in the organization.Research was split into 3 stages. Stage one consisted of studying the literature. At the second stage, we proceeded with the assessment of content and face validity of the research tool. Within the third stage of the research, the construct was subject to theoretical validity check. Validation proved that the obtained model of erotic capital fulfilled the requirements of: reliability, validity (divergent and predictive) and unidimensionality.

PCR25 Content Validity Assessment of a Newly-Developed Patient-Reported Outcome Measure for Dry Eye Disease (DED), Meibomian Gland Dysfunction (MGD), and Sjogren's Syndrome Dry Eye Disease (SS-DED)

The aim of this research was to evaluate the content validity of the Dry Eye Disease Questionnaire (DED-Q), a newly-developed patient-reported outcome measure suitable for use in Dry Eye Disease (DED), Meibomian Gland Dysfunction (MGD), and Sjogren’s Syndrome Dry Eye Disease (SS-DED).

Measuring clinical trial set-up complexity: development and content validation of a pharmacy scoring tool to support workload planning

Abstract Introduction Clinical trials are essential for advancing medical knowledge and patient care. Pharmacy plays a vital role in research delivery, safeguarding participants, healthcare professionals and Trusts by ensuring Investigational Medicinal Products (IMPs) are procured, handled, stored, dispensed and used safely. Data have emerged indicating that clinical trial protocols are increasingly more complex for site personnel to execute. Whilst various tools have been developed to support workload planning and costing of clinical trials for clinicians and nursing personnel, the equivalent tool for pharmacy activities is not available.1,2 Aim This study aims to locally develop and validate a pharmacy scoring tool to assess clinical trial complexity at the set-up stage. Objectives are to develop pharmacy-scoring tool to quantify clinical trials execution complexity with respect to pharmacy activities and determine Content Validity Index (CVI) and Inter-Rater Agreement (IRA) of the scoring tool through an internal vetting process. Methods A three-stage process was used to develop and validate the scoring tool. Two researchers contextualised the pharmacy–specific items, organised the content and constructed the tool based on suitable elements for inclusion through a targeted literature search and outputs from an expert panel meeting. Four experts independently rated each items on its relevance, clarity and alignment with clinical trial complexity considerations at the set-up stage using a 4-point Likert scale. Following data analysis, researchers made a judgement on whether to retain, modify, omit or add new items to the tool. Where the desired level of content validity had not been achieved for an item, revisions were made following a group discussion and the tool was re-distributed to the same expert panel for a second round of assessment. Item level-CVI (I-CVI) and tool level-CVI (average-CVI) was calculated for each round. Four experts then utilised the revised tool to retrospectively review 20 random studies to evaluate clinical trial complexity scores independently. IRA among assessors was measured for each individual pharmacy-specific item by dividing the responses into dichotomous ratings (one or two vs. three or four). The study was deemed a service evaluation and approved by the Trust Pharmacy Research and Audit Group therefore ethical submission was waived. Results Fourteen pharmacy-specific items were identified for inclusion in the tool with a possible score of 0-3 points per item. The highest possible complexity score when adding up all items is 42 points with a scale of low 0-14, moderate &amp;gt;14-28, and high &amp;gt;28-42. Following two rounds of content validity assessment where clarity revisions were made to four items, 14 out of 14 scored I-CVI of 1 with overall tool level average-CVI score of 1. The IRA shows 100% agreement by item and tool. Discussion/Conclusion This clinical trial’s complexity-scoring tool is the first of its kind tailored for pharmacy set-up in the UK. Overall, the results from this study support validity and reliability (content and construct) of this locally developed tool. The formal agreement on the use of this tool with the Trust Research Lead has better facilitated workload and capacity planning as well as ensuing costings for Pharmacy clinical trial activities.

Development and psychometric evaluation of a new brief scale to measure eHealth literacy in people with type 2 diabetes

BackgroundThe internet has become a major source of health information, and obtaining appropriate information requires various abilities and skills, labeled as electronic health literacy (eHealth literacy). The existing instruments for measuring eHealth literacy are outdated because they were developed during the Web 1.0 era, or not sufficiently sensitive for people with a specific condition or disease because they were designed to assess eHealth literacy over a broad range for a general population. Approximately one in ten adults worldwide live with diabetes. Health professionals have a responsibility to identify patients with low eHealth literacy to prevent them from obtaining misleading internet diabetes information.AimsThe aims were to develop a condition-specific eHealth literacy scale for diabetes and to evaluate its psychometric properties among people with type 2 diabetes.MethodsAn instrument development design was used. This study recruited 453 people diagnosed with type 2 diabetes at the outpatient clinics of hospitals in 2021. Psychometric properties (internal consistency, measurement invariance, and content, structural, convergent, and known-groups validities) were analyzed.ResultsAn expert panel assessed content validity. Exploratory factor analysis, exploratory graph analysis, and confirmatory factor analysis (CFA) for structural validity yielded a two-factor solution (CFI = 0.977, SRMR = 0.029, RMSEA = 0.077). Cronbach’s alpha and omega values were excellent for each factor (0.87–0.94). Multigroup CFA yielded configural and metric measurement invariance across the gender, age, and glycemic control status groups. Convergent validity with a comparator instrument to measure health literacy was supported by a moderate correlation, and known-groups validity determined using groups with different internet-use frequencies was satisfied with a high effect size.ConclusionA new condition-specific eHealth literacy scale for people with type 2 diabetes was developed, comprising 10 items. The scale exhibited good psychometric properties; however, test–retest reliability must be determined for the stability of the scale and cross-cultural validity is required among different languages. The brief scale has the merits of being feasible to use in busy clinical practice and being less burdensome to respondents. The scale can be applied in clinical trials of internet-based diabetes interventions for assessing the eHealth literacy of respondents.