Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial
| Autor: | Imke Backhus, Christoph Heesen, Sascha Köpke, Franz Fuest, Adrianus van de Roemer, Anne Christin Rahn, Ingrid Mühlhauser, Karin Riemann-Lorenz |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
medicine.medical_specialty Multiple Sclerosis Statistics as Topic Pilot Projects Health Informatics computer.software_genre Health Services Accessibility law.invention 03 medical and health sciences 0302 clinical medicine Patient Education as Topic Randomized controlled trial Cronbach's alpha law Clinical endpoint medicine Humans Interview 030212 general & internal medicine Pilot randomised controlled trial Qualitative Research Multiple choice Consumer Health Information business.industry Health Policy Confidence interval Computer Science Applications Test (assessment) Clinical trial Comprehension Patient information Physical therapy Feasibility Studies Data mining business computer 030217 neurology & neurosurgery Research Article |
| Zdroj: | BMC Medical Informatics and Decision Making |
| ISSN: | 1472-6947 |
| DOI: | 10.1186/s12911-016-0362-8 |
| Popis: | Background Presentation of confidence intervals alongside information about treatment effects can support informed treatment choices in people with multiple sclerosis. We aimed to develop and pilot-test different written patient information materials explaining confidence intervals in people with relapsing-remitting multiple sclerosis. Further, a questionnaire on comprehension of confidence intervals was developed and piloted. Methods We developed different patient information versions aiming to explain confidence intervals. We used an illustrative example to test three different approaches: (1) short version, (2) “average weight” version and (3) “worm prophylaxis” version. Interviews were conducted using think-aloud and teach-back approaches to test feasibility and analysed using qualitative content analysis. To assess comprehension of confidence intervals, a six-item multiple choice questionnaire was developed and tested in a pilot randomised controlled trial using the online survey software UNIPARK. Here, the average weight version (intervention group) was tested against a standard patient information version on confidence intervals (control group). People with multiple sclerosis were invited to take part using existing mailing-lists of people with multiple sclerosis in Germany and were randomised using the UNIPARK algorithm. Participants were blinded towards group allocation. Primary endpoint was comprehension of confidence intervals, assessed with the six-item multiple choice questionnaire with six points representing perfect knowledge. Results Feasibility of the patient information versions was tested with 16 people with multiple sclerosis. For the pilot randomised controlled trial, 64 people with multiple sclerosis were randomised (intervention group: n = 36; control group: n = 28). More questions were answered correctly in the intervention group compared to the control group (mean 4.8 vs 3.8, mean difference 1.1 (95 % CI 0.42–1.69), p = 0.002). The questionnaire’s internal consistency was moderate (Cronbach's alpha = 0.56). Conclusions The pilot-phase shows promising results concerning acceptability and feasibility. Pilot randomised controlled trial results indicate that the patient information is well understood and that knowledge gain on confidence intervals can be assessed with a set of six questions. Trial registration German Clinical Trials Register: DRKS00008561. Registered 8th of June 2015. Electronic supplementary material The online version of this article (doi:10.1186/s12911-016-0362-8) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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