108 | Chapter 6 Secondary analyses In addition to the main analysis, we performed an a priori defined stratified analysis for frailty status (i.e. non- and pre-frail). Furthermore, we conducted two sensitivity analyses to assess the robustness of the findings. For the first sensitivity analysis (SA1), we conducted a per-protocol analysis. This analysis included only participants who complied with the designated protocols, excluding those with less than 75% attendance in the intervention group and those in the control group who participated in any fall prevention intervention (242). In the Netherlands the societal perspective is the preferred perspective, meaning that all costs are considered regardless of who bears them (22). The advantage of using the societal perspective over narrower perspectives such as the healthcare perspective is that (unexpected) shifts in costs between sectors can be identified (257). Some other countries make decisions from a healthcare perspective. To inform health insurers and to be able to compare results of this study with literature, the second sensitivity analysis (SA2) was conducted from a healthcare perspective, meaning that we excluded lost productivity costs, and patient and family costs (271). RESULTS Participants Between June 2021 and January 2023, 849 potential participants were screened for eligibility (Figure 6.1). Of these, 264 people were included in the study between August 2021 and January 2023 and were randomly assigned to the intervention group (n = 131) or the control group (n = 133). Follow-up finished in January 2024. In the intervention group, 40 (30%) participants were classified as non-frail and 91 (70%) as pre-frail. In the control group, 37 (28%) participants were non-frail and 96 (72%) were pre-frail (Figure 6.1). No clinically relevant differences in baseline characteristics were observed between the intervention and control groups (Table 6.1). Likewise, there were no relevant baseline differences between groups after stratifying for frailty or in the per-protocol sample (Appendix 6.2, Table A6.2 and Appendix 6.3, Table A6.3). The rate of missing data was 10.4% for fall diaries and follow-up calls, and 16.5% for cost and quality of life questionnaires in the intervention group. In the control group, the percentages of missing data were 15.0% and 26.1%, respectively. Participants with complete data had statistically significantly higher Mini-Mental State Examination scores (indicating better cognitive functioning) and a lower fall history at baseline.
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