Browsing by Subject "hyväksyttävyys"

Tiivistelmä – Referat – Abstract 15D is a generic, 15-dimensional instrument for measuring health-related quality of life (HRQoL). 15D instrument has been used in multiple studies evaluating the effectiveness of medical interventions in Finland and abroad. 15D-instrument is a self-administered questionnaire traditionally administered in a paper-and-pencil format. With the emergence of novel technologies, electronic modes of delivery of the 15D instrument are becoming increasingly common as methods for data collection. However, there are no previous studies evaluating electronic modes of delivery of the 15D instrument. In previous studies, electronic instruments measuring patient-reported outcomes have shown strong measurement equivalence and high acceptability. The aim of this study is to evaluate acceptability and measurement equivalence of electronic delivery modes of the 15D instrument. A repeated measures, randomized cross-over study was conducted in the Department of Otorhinolaryngology at Helsinki University Hospital during April, May and June of 2019. A total of 160 outpatients who participated in the study were randomized into four groups of 40 patients. Every participant filled two delivery modes of the 15D instrument: a single paper-and-pencil questionnaire and one out of two electronic questionnaires provided in the study. The two electronic delivery modes delivered in the study were a web-based questionnaire and a mobile app-based questionnaire. The order and the mode of the administration varied between the groups. The patients filled the first questionnaire before the doctor’s appointment at the study site. The patients were then asked to fill the second questionnaire after the doctor’s appointment at home within 3 days after the first administration. Information about acceptability concerning different delivery modes were collected using an end-of-study questionnaire. As a part of determining patient acceptability, response rates for different delivery forms and mode preferences were examined. Measurement equivalence was assessed by intra class correlation coefficients (ICCs) and comparison of mean and median for 15D scores and weighted kappa for item scores. Paired observations were also visually analysed with Bland-Altman plots. Subgroup analyses were conducted for identifying differences in observed patient characteristics (age, sex, base-line HRQoL). 86 participants (females 53.5 %; males 46.5 %) aged 18 to 80 (mean ± SD: 48.2 ± 15.7) filled both questionnaires of the 15D instrument resulting in an overall response rate of 54.1%. Response rates for filling both questionnaires were lower in both groups that filled electronic forms at home (41.0 % for mobile app-based and 52.5 % for web-based questionnaires) than in the paper-and-pencil groups (60.0 % and 62.5 %). Overall 74.1 % preferred the electronic delivery mode compared to 16.5 % preferring the paper-and-pencil mode. Statistically significant differences favouring the web-based form over the paper-and-pencil form were observed in the speed of use (p = 0.002) and in the possibility to edit answers (p = 0.018). Similarly, mobile app-based form was favoured over paper-and-pencil group in the possibility to edit answers (p = 0,041). In terms of measurement equivalence for 15D index scores, high association across paper-and-pencil and web-based questionnaires (ICC: 0.910 [Cl 95 % 0.794-0.962] and ICC: 0.935 [Cl 95 % 0.862-0.971]) and high to moderate across paper-and-pencil and mobile app-based questionnaires (ICC: 0.949 [Cl 95 % 0.883-0.978] and ICC: 0.928 [Cl 95 % 0.601-0.980]) were observed. A clinically important and a statistically significant difference in mean 15D scores was identified in the paper-mobile app group. A statistically significant but not clinically important difference in medians was observed in mobile app-paper group with participants returning the second delivery form in time. This study provides strong evidence supporting the use of electronic delivery modes of the 15D instrument regarding measurement equivalence and patient acceptability. However, differences in electronic delivery modes may have an impact on measurement equivalence and representativeness of study participants. In this study, a small sample size and limited data on study participants limit the generalizability of the results. Most effective ways of collecting data electronically concerning all age and patient groups must be identified in future studies. Electronic data collection methods offer many opportunities for utilising HRQoL data. For example, it is important to assess whether HRQoL-instruments can be used as clinical tools in the future.