gms | German Medical Science

Introduction: Clinical trials are the gold standard for evidence-based practice. While randomised controlled trials (RCT) are routinely used for the evaluation of pharmaceuticals and medical products, some areas of clinical practice are systematically underrepresented in clinical trials. The aim of the study was to explore the current trends of clinical trials in nursing, physical therapy, occupational therapy, speech therapy and midwifery [1].

Methods: We conducted the search (08/09/2022) using the German Clinical Trial Register (DRKS, [2]) to collect information about interventions, funding, location, ICD-10 coding, and recruitment of studies found entering the individual health care profession. Inclusion criteria were study location in Germany, publication within the last 10 years and relevance to health care interventions. Analysis focused on descriptive statistics to examine current trends and developments.

Results: In total 442 clinical trials were included for analysis. Related to the health care professions, 44% (n= 193) of the clinical trials were initiated by physical therapists, 43% (n= 191) by nurses, 7% (n= 33) by occupational therapists, 4% (n= 17) by speech therapists and 2% (n= 8) by midwifes. The highest number of clinical trials is located in North Rhine-Westphalia (n= 97, 22%), Bavaria (n= 76, 17 %) and Baden-Wuerttemberg (n= 69, 16%). Over the years (2012-2022), the total number of clinical trials raised from n= 11 to n= 56 per year. Main intervention categories (ICD-10) focused on mental and behavioural disorders (ICD-10, Chapter 5), primarily in the field of nursing and secondly, diseases of the musculoskeletal system and connective tissue (ICD-10, Chapter 13) in physical therapy. Funding for the clinical trials is mainly provided by in-house budgets (physical therapy) and taxpayers’ money (nursing). Clinical research sites are predominantly university hospitals.

Discussion: This study offers important insights about clinical trials in the group of health care professions in Germany. The results demonstrate a strong association with a clinical background in nursing or physiotherapy, and targets in mental / behavioural and musculoskeletal disorders. This should relate to a solid evidence-base in these clinical fields, while neglecting other important areas of clinical interventions (i. e. diabetes, heart diseases) [3]. The analysis also shows that most interventions are developed and tested by university hospitals. This may lead to a lack of evidence in the outpatient care sector. Some limitations need to be considered with the interpretation of our results: we only used a single register for identification (DRKS), our selected search terms were profession oriented, we might have missed studies not connecting the intervention to a specific profession in the protocol. Future research may be determined to other registries and even an international comparison to further rational our findings [4].

Conclusion: The results of this study show well established fields and underrepresented areas of clinical investigations in the group of health care professions in Germany. The related discussion about clinical investigation projects should help to facilitate additional funding and a wider clinical scope. Clinical research in health care professions should be supported by tailored public funding programs, addressing neglected areas of research and wider the evidence base in these professions.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.