gms | German Medical Science

Objectives: More than 2 years after the launch of the first digital therapeutics (DTx) as “Digitale Gesundheitsanwendungen” (DiGA) in Germany, DTx are becoming more widely used in routine care delivery. While permanent listing as a DiGA requires the robust demonstration of clinical effectiveness, primarily in a trial setting, different factors modifying clinical effectiveness along the real-world treatment pathway remain to be explored. This work employs a propensity score (PS) matching approach on real-world use data to assess the effect of different levels of therapeutic adherence on the achievement of a clinically relevant pain reduction.

Methods: 7,629 patients who enrolled in the home exercise program for back pain between Oct 20, 2020 and Feb 17, 2022, completed at least one exercise and reported at least one pain score, based on a verbal-numerical rating scale (VNRS), were included in this retrospective study. Use intensity of the exercise program was categorized as either high intensity (HI, ≥ three training completed days per week), intermediate intensity (II, ≥ two training days per week), or low intensity (LI, ≥ one training day per week). Outcome was assessed binarily as the achievement of a clinically relevant improvement of pain intensity, which was established at 30% of pain reduction in accordance with global consensus [1]. A PS was estimated based on the baseline covariates of gender, concomitant physical therapy and/or pain medication, and the chronicity of the pain. The assumption of conditional independence was assumed to hold due to use of independent baseline covariates only; a balanced distribution of covariates was assessed per quintile of the PS. A region of common support was identified graphically. Matching was performed as a nearest-neighbor matching with n=5 between exposed and unexposed in each stratum, respectively. Results were adjusted for multiple testing using the Bonferroni method.

Results and conclusion: The probability of achieving a clinically relevant reduction of pain intensity was significantly higher (11.4%) among patients who at least achieved a LI use. If patients achieved a II use, the probability was significantly higher (11.8%) in comparison to LI and sub-LI users combined. Among patients with a HI use, the probability of achieving a clinically relevant improvement was significantly higher (9.1%) when compared to II, LI and sub-LI users (Table 1 [Tab. 1]).

Although this study does not yield confirmatory power and further research is required, we see a clear benefit for patients who achieve any higher level of use intensity. In accordance with WHO recommendations [2], all stakeholders along the treatment pathway of the patient should aim to optimize adherence-modifying factors for the patient (i.e. health systems, socio-economic, condition-, treatment- and patient-specific factors) to ensure the best possible clinical effectiveness.