Current Technology Developments Can Improve the Quality of Research and Level of Evidence for Rehabilitation Interventions: A Narrative Review

Abstract

The current important limitations to the implementation of Evidence-Based Practice (EBP) in the rehabilitation field are related to the validation process of interventions. Indeed, most of the strict guidelines that have been developed for the validation of new drugs (i.e., double or triple blinded, strict control of the doses and intensity) cannot-or can only partially-be applied in rehabilitation. Well-powered, high-quality randomized controlled trials are more difficult to organize in rehabilitation (e.g., longer duration of the intervention in rehabilitation, more difficult to standardize the intervention compared to drug validation studies, limited funding since not sponsored by big pharma companies), which reduces the possibility of conducting systematic reviews and meta-analyses, as currently high levels of evidence are sparse. The current limitations of EBP in rehabilitation are presented in this narrative review, and innovative solutions are suggested, such as technology-supported rehabilitation systems, continuous assessment, pragmatic trials, rehabilitation treatment specification systems, and advanced statistical methods, to tackle the current limitations. The development and implementation of new technologies can increase the quality of research and the level of evidence supporting rehabilitation, provided some adaptations are made to our research methodology.

Keywords: methods; new technology; rehabilitation; study design; validation.

Figure 2

Study design and levels of evidence [16]. This pyramid could be more detailed, but the general idea is to differentiate the four kinds of studies: The meta-analysis of published studies is at the top (e.g., systematic review and meta-analysis), as level I evidence. Then the experimental studies—fully controlled (RCT) and pseudo-RCT (level II) quasi-experimental designs (i.e., prospective studies). The observational large-scale studies (cohort studies and case–control studies (level III)) and the case reports or case series are at the base of the pyramid, with a low level of evidence (level IV). Finally, expert opinion, not based on any scientific data or evidence, represents the lowest level of evidence (level V).

Figure 1

The rocket model, adapted from Verweij et al., 2019 [11]. Note that this model and its numbers relate to the development of new drugs, as no data are available for new interventions in rehabilitation sciences. Blue colors indicate the different steps of the discovery, development and preclinical research, orange represents the clinical development. The different steps of the clinical development are as follows. Phase 1—healthy volunteer study: this is the first time the drugs is tested in people; less than 100 volunteers are usually involved, and the pharmacokinetics, absorption, metabolism, and excretion effects on the body, as well as any adverse effects associated with safe dose ranges, will be determined. Phase 2—small sample size study in patient population: Evaluates the safety and effectiveness of the medicine in an additional 100–500 patients who may receive a placebo or a previously utilized standard of care. The analysis of the ideal dosage strength aids in the development of schedules, while adverse events and dangers are documented. Phase 3—large-scale clinical study: typically enrolls 1000–5000 patients, allowing medication labeling and adequate drug usage instructions. Phase 3 studies need substantial cooperation, planning, and coordination and control on the part of an Independent Ethics Committee (IEC) or an Institutional Review Board (IRB) in preparation for full-scale manufacturing after medication approval.

Figure 3

Relationship between time and cost of the different study design.