Dataset Information

Development and psychometric validation for evaluating written medicine information in Thailand: The Consumer Information Rating Form.

ABSTRACT:

Objective

To translate and validate the consumer information rating form (CIRF) for use in Thai populations.

Design

The development of the CIRF was carried out in two phases: translation process and cognitive interview, and psychometric testing.

Setting

A university hospital and a tertiary hospital in northeast Thailand.

Participants

150 outpatients from medicine department: 30 for phase 1 and 120 patients for phase 2 study.

Methods

The CIRF was translated with cultural adaptation into Thai using cognitive interview technique in a sample of outpatients. A larger sample of outpatients then completed the CIRF in relation to either a package insert (PI) or a patient information leaflet (PIL) for one of three medicines: atorvastatin, celecoxib and metformin. Construct validity was assessed using principal component analysis (PCA) and internal consistency using Cronbach's α coefficient. Known group validity was assessed by comparing mean consumers' ratings for PIs and PILs.

Results

Thirty participants engaged in the cognitive interview and 120 participants completed the CIRF. The PCA found the 17 items of the CIRF were extracted into three factors: comprehensibility, utility and design quality scales, mirroring the original. Cronbach's α for the overall scale (0.904) indicated good internal consistency. Known-group validity demonstrated significant differences in consumers' rating between PIs and PILs for almost all items (p<0.001).

Conclusion

Thai version of CIRF had acceptable validity and reliability for Thai consumers' ratings of written medicine information. The CIRF could be of practical use in the process of developing medicine information to ensure consumers' comprehension and their usefulness.

SUBMITTER: Wongtaweepkij K

PROVIDER: S-EPMC8488703 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ImportanceOlfactory dysfunction (OD) is an increasingly common and morbid condition, especially given the ongoing COVID-19 pandemic. Thus, the ability to reproducibly measure smell loss-associated quality of life (QOL) and its response to treatment is paramount.ObjectiveTo develop and validate a concise and visually appealing smell loss-associated QOL patient-reported outcome measure for OD.Design, setting, and participantsA secondary analysis of comments to an online survey by 1000 patients with olfactory dysfunction published in 2013 was used as the primary source to generate items of the Olfactory Dysfunction Outcomes Rating (ODOR). In addition, 30 patients with OD enrolled in 2 clinical studies at a tertiary care medical center (Washington University) were asked to identify their main concerns associated with smell loss. And finally, 4 otolaryngologists reviewed the items generated from the online survey and the patients' interviews to identify any additional items. Prospective study design was used for data collection from the 30 patients and 4 otolaryngologists. Prospective study design was used for survey validation. Validation of the ODOR was performed with 283 patients enrolled in several prospective studies at a single institution that completed the ODOR as an outcome measure.Main outcomes and measuresItem generation and selection were the outcomes of ODOR development. The psychometric and clinimetric measures evaluated for validation were internal consistency, test-retest reliability, face and content validity, concurrent validity, and discriminant validity. Minimal clinically important difference was also determined.ResultsThe ODOR is a 28-item instrument with each item scored as either no difficulty or very rarely bothered (0) to complete difficulty or very frequently bothered (4) with a total instrument score range of 0 to 112 points. Higher scores indicate higher degree of dysfunction and limitation. Validation in the cohort of 283 patients (mean [SD] age, 47.0 [14.4] years; 198 female participants [73%]; 179 White participants [80%]) revealed that the instrument has high internal consistency (Cronbach α = 0.968), test-retest reliability (r = 0.90 [95% CI, 0.81-0.95]), face validity, content validity, concurrent validity (r = 0.87 [95% CI, 0.80-0.91] compared with the Questionnaire of Olfactory Disorders-Negative Statements; ρ = -0.76 [95% CI, -0.81 to -0.71] compared with a patient-reported symptom severity scale), and divergent validity (mean score difference, -33.9 [95% CI, -38.3 to -29.6] between normosmic patients and hyposmic/anosmic patients). The minimal clinically important difference was 15 points. The estimated time for survey completion was approximately 5 minutes.Conclusions and relevanceIn this survey creation and validation study, the ODOR was shown to be a novel, concise, reliable, and valid patient-reported outcome measure of OD-associated QOL. It can be used to measure physical problems, functional limitations, and emotional consequences associated with OD and how they change after a given intervention, which is clinically applicable and particularly pertinent given the growing burden of OD associated with COVID-19.

Project description:BackgroundMedication is the most common intervention in health care, and the number of online consumer information systems within the pharmaceutical sector is increasing. However, online consumer information systems can be a barrier for users, imposing information asymmetries between stakeholders.ObjectiveThe objective of this study was to quantify and compare the usability of an online consumer medication information system (OCMIS) against a reference implementation based on an interoperable information model for patients, physicians, and pharmacists.MethodsQuantitative and qualitative data were acquired from patients, physicians, and pharmacists in this online usability study. We administered 3 use cases and a post hoc questionnaire per user. Quantitative usability data including effectiveness (task success), efficiency (task time), and user satisfaction (system usability scale [SUS]) was complemented by qualitative and demographic data. Users evaluated 6 existing systems and 1 reference implementation of an OCMIS.ResultsA total of 137 patients, 81 physicians, and 68 pharmacists participated in this study. Task success varied from 84% to 92% in patients, 66% to 100% in physicians, and 50% to 91% in pharmacists. Task completion time decreased over the course of the study for all but 2 OCMIS within the patient group. Due to an assumed nonnormal distribution of SUS scores, within-group comparison was done using the Kruskal-Wallis test. Patients showed differences in SUS scores (P=.02) and task time (P=.03), while physicians did not have significant differences in SUS scores (P=.83) and task time (P=.72). For pharmacists, a significant difference in SUS scores (P<.001) and task time (P=.007) was detected.ConclusionsThe vendor-neutral reference implementation based on an interoperable information model was proven to be a promising approach that was not inferior to existing solutions for patients and physicians. For pharmacists, it exceeded user satisfaction scores compared to other OCMIS. This data-driven approach based on an interoperable information model enables the development of more user-tailored features to increase usability. This fosters data democratization and empowers stakeholders within the pharmaceutical sector.

Project description:Post stroke dysphagia (PSD) is common and associated with poor outcome. The Dysphagia Severity Rating Scale (DSRS), which grades how severe dysphagia is based on fluid and diet modification and supervision requirements for feeding, is used for clinical research but has limited published validation information. Multiple approaches were taken to validate the DSRS, including concurrent- and predictive criterion validity, internal consistency, inter- and intra-rater reliability and sensitivity to change. This was done using data from four studies involving pharyngeal electrical stimulation in acute stroke patients with dysphagia, an individual patient data meta-analysis and unpublished studies (NCT03499574, NCT03700853). In addition, consensual- and content validity and the Minimal Clinically Important Difference (MCID) were assessed using anonymous surveys sent to UK-based Speech and Language Therapists (SLTs). Scores for consensual validity were mostly moderate (62.5-78%) to high or excellent (89-100%) for most scenarios. All but two assessments of content validity were excellent. In concurrent criterion validity assessments, DSRS was most closely associated with measures of radiological aspiration (penetration aspiration scale, Spearman rank rs?=?0.49, p?<?0.001) and swallowing (functional oral intake scale, FOIS, rs?=?-0.96, p?<?0.001); weaker but statistically significant associations were seen with impairment, disability and dependency. A similar pattern of relationships was seen for predictive criterion validity. Internal consistency (Cronbach's alpha) was either "good" or "excellent". Intra and inter-rater reliability were largely "excellent" (intraclass correlation >0.90). DSRS was sensitive to positive change during recovery (medians: 7, 4 and 1 at baseline and 2 and 13 weeks respectively) and in response to an intervention, pharyngeal electrical stimulation, in a published meta-analysis. The MCID was 1.0 and DSRS and FOIS scores may be estimated from each other. The DSRS appears to be a valid tool for grading the severity of swallowing impairment in patients with post stroke dysphagia and is appropriate for use in clinical research and clinical service delivery.

Project description:BackgroundUncertainty is integral to evidence-informed decision making and is of particular importance for preference-sensitive decisions. Communicating uncertainty to patients and the public has long been identified as a goal in the informed and shared decision-making movement. Despite this, there is little quantitative research on how uncertainty in health information is perceived by readers.ObjectiveThe aim of this study was to examine the impact of different uncertainty descriptions regarding the evidence for a treatment effect in a written research summary for the public.MethodsWe developed 8 versions of a research summary on a fictitious drug for tinnitus with varying degrees (Q1), sources (Q2), and magnitudes of uncertainty (Q3). We recruited 2099 members of the German public from a web-based research panel. Of these, 1727 fulfilled the inclusion criteria and were randomly presented with one of these research summaries. Randomization was conducted by using a centralized computer with a random number generator. Web-based recruitment and data collection were fully automated. Participants were not aware of the purpose of the study and alternative presentations. We measured the following outcomes: perception of the treatment effectiveness (primary), certainty in the judgement of treatment effectiveness, perception of the body of evidence, text quality, and intended decision. The outcomes were self-assessed.ResultsFor the primary outcome, we did not find a global effect for Q1 and Q2 (P=.25 and P=.73), but we found a global effect for Q3 (P=.048). Pairwise comparisons showed a weaker perception of treatment effectiveness for the research summary with 3 sources of uncertainty compared to the version with 2 sources of uncertainty (P=.04). Specifically, the proportion of the participants in the group with 3 sources of uncertainty that perceived the drug as possibly beneficial was 9% lower than that of the participants in the group with 2 sources of uncertainty (92/195, 47.2% vs 111/197, 56.3%, respectively). The proportion of the participants in the group with 3 sources of uncertainty that considered the drug to be of unclear benefit was 8% higher than that of the participants in the group with 2 sources of uncertainty (72/195, 36.9% vs 57/197, 28.9%, respectively). However, there was no significant difference compared to the version with 1 source of uncertainty (P=.31). We did not find any meaningful differences between the research summaries for the secondary outcomes.ConclusionsCommunicating even a large magnitude of uncertainty for a treatment effect had little impact on the perceived effectiveness. Efforts to improve public understanding of research are needed to improve the understanding of evidence-based health information.Trial registrationGerman Clinical Trials Register DRKS00015911, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015911.International registered report identifier (irrid)RR2-10.2196/13425.

Project description:AimsTo develop and validate a short form of the 54-item Diabetes Medication System Rating Questionnaire that maintains the domains and performance characteristics of the long-form questionnaire.MethodsData from the Diabetes Medication System Rating Questionnaire validation study were analysed to select items representing the nine scales (convenience, negative events, interference, self-monitoring of blood glucose burden, efficacy, social burden, psychological well-being, treatment satisfaction and treatment preference). The resulting 20-item Diabetes Medication System Rating Questionnaire Short-Form was administered online, with validated criterion measures of treatment satisfaction and medication adherence, with a retest within 2 weeks. Participants were US adults (N = 413) with Type 2 diabetes using oral agents alone; insulin by syringe and/or pen with or without oral agents; or glucagon-like peptide-1 agents. Most participants (82%) completed the retest.ResultsThe median inter-item agreement of scales was 0.76 and the total composite (mean of all items except treatment preference) was 0.88. The median test-retest reliability of scales was 0.86, and of the total composite was 0.95. All statistically significant correlations between Diabetes Medication System Rating Questionnaire Short-Form scales and criterion measures of treatment satisfaction and adherence were in the expected direction. The median correlation of the Diabetes Medication System Rating Questionnaire Short-Form with corresponding criterion measures of treatment satisfaction was 0.59; the mean correlation of the same Diabetes Medication System Rating Questionnaire Short-Form measures with adherence was 0.42. The Diabetes Medication System Rating Questionnaire Short-Form scales were more powerful predictors of adherence than were the criterion measures of treatment satisfaction. The Diabetes Medication System Rating Questionnaire Short-Form scales differentiated between those taking different medications and between those using different insulin delivery devices.ConclusionsThis study suggests that the Diabetes Medication System Rating Questionnaire Short-Form provides a comprehensive set of measures with acceptable reliability and validity and a reduced burden of administration.

Project description:BACKGROUND: In developing the PatientsLikeMe online platform for patients with Multiple Sclerosis (MS), we required a patient-reported assessment of functional status that was easy to complete and identified disability in domains other than walking. Existing measures of functional status were inadequate, clinician-reported, focused on walking, and burdensome to complete. In response, we developed the Multiple Sclerosis Rating Scale (MSRS). METHODS: We adapted a clinician-rated measure, the Guy's Neurological Disability Scale, to a self-report scale and deployed it to an online community. As part of our validation process we reviewed discussions between patients, conducted patient cognitive debriefing, and made minor improvements to form a revised scale (MSRS-R) before deploying a cross-sectional survey to patients with relapsing-remitting MS (RRMS) on the PatientsLikeMe platform. The survey included MSRS-R and comparator measures: MSIS-29, PDDS, NARCOMS Performance Scales, PRIMUS, and MSWS-12. RESULTS: In total, 816 RRMS patients responded (19% response rate). The MSRS-R exhibited high internal consistency (Cronbach's alpha?=?.86). The MSRS-R walking item was highly correlated with alternative walking measures (PDDS, ??=?.84; MSWS-12, ??=?.83; NARCOMS mobility question, ??=?.86). MSRS-R correlated well with comparison instruments and differentiated between known groups by PDDS disease stage and relapse burden in the past two years. Factor analysis suggested a single factor accounting for 51.5% of variance. CONCLUSIONS: The MSRS-R is a concise measure of MS-related functional disability, and may have advantages for disease measurement over longer and more burdensome instruments that are restricted to a smaller number of domains or measure quality of life. Studies are underway describing the use of the instrument in contexts outside our online platform such as clinical practice or trials. The MSRS-R is released for use under creative commons license.

Project description:BackgroundVarious types of framing can influence risk perceptions, which may have an impact on treatment decisions and adherence. One way of framing is the use of verbal terms in communicating the probabilities of treatment effects. We systematically reviewed the comparative effects of words versus numbers in communicating the probability of adverse effects to consumers in written health information.MethodsNine electronic databases were searched up to November 2012. Teams of two reviewers independently assessed studies.Inclusion criteriarandomised controlled trials; verbal versus numerical presentation; context: written consumer health information.ResultsTen trials were included. Participants perceived probabilities presented in verbal terms as higher than in numeric terms: commonly used verbal descriptors systematically led to an overestimation of the absolute risk of adverse effects (Range of means: 3% - 54%). Numbers also led to an overestimation of probabilities, but the overestimation was smaller (2% - 20%). The difference in means ranged from 3.8% to 45.9%, with all but one comparison showing significant results. Use of numbers increased satisfaction with the information (MD: 0.48 [CI: 0.32 to 0.63], p < 0.00001, I2 = 0%) and likelihood of medication use (MD for very common side effects: 1.45 [CI: 0.78 to 2.11], p = 0.0001, I2 = 68%; MD for common side effects: 0.90 [CI: 0.61 to 1.19], p < 0.00001, I2 = 1%; MD for rare side effects: 0.39 [0.02 to 0.76], p = 0.04, I2 = not applicable). Outcomes were measured on a 6-point Likert scale, suggesting small to moderate effects.ConclusionsVerbal descriptors including "common", "uncommon" and "rare" lead to an overestimation of the probability of adverse effects compared to numerical information, if used as previously suggested by the European Commission. Numbers result in more accurate estimates and increase satisfaction and likelihood of medication use. Our review suggests that providers of consumer health information should quantify treatment effects numerically. Future research should focus on the impact of personal and contextual factors, use representative samples or be conducted in real life settings, measure behavioral outcomes and address whether benefit information can be described verbally.