Characterization and Critical Appraisal of Physiotherapy Intervention Research in Nigeria: A Systematic Review

Objectives Clinical research is the bedrock of clinical innovation, education and practice. We characterized and critically appraised physiotherapy clinical research to avoid implementing misleading research findings into practice and to task the Nigerian physiotherapy societies on responsible conduct of clinical research. Methods This is a systematic review of articles published in English between 2009 and 2021. We searched Pubmed, Medline, Cumulative Index to Nursing and Allied Health Literature, Academic Search Complete, PsycINFO and African Journal Online, and reference lists of relevant articles. Data were selected and extracted according to predesigned eligibility criteria and using a standardized data extraction table. Where appropriate, the Pedro and Cochrane ROBINS1 were used to examine the risk of bias. Results Of the clinical experiments, the randomized controlled trial (RCT) was the most common design (87.5%). Musculoskeletal conditions (39.3%) were the most studied disorder. Most of the studies (76.8%) were of suboptimal quality. Interventions constituted exercise therapy (76.3%), manual therapy (8.5%) and electrotherapy (8.5%). More than half (67.8%) of the studies recorded medium to large effect sizes. A fair proportion (48.2%) of the studies had a confounding-by-indication bias. A few studies conducted normality tests (10.9%) and intention-to-treat analysis (37.5%). Discussion Of the clinical research, the volume of clinical experiments in the Nigeria Physiotherapy research community is small; notwithstanding, RCT is the most frequent clinical experiment. Physiotherapy interventions especially exercise appears effective, although incongruence between effect size and study quality limits inference. Sources of bias include absent/inadequate covariate analysis, blinding and intention-to-treat analysis approach. Registration: We registered the protocol with PROSPERO. The registration number: CRD42021228514.

Perspectives on Challenges to Cell Therapy Development in Taiwan: Strengthening Evidential Standards and Ways Forward

Over the past years, the field of regenerative medicine and cell therapy has garnered much interest, extending beyond the bench to broader use, and commercialization. These therapies undergo stringent regulatory oversight as a result of their complexities and potential risk across different jurisdictions. Taiwan’s government, with the aim of developing the country as a hub for regenerative medicine in Asia, enacted a dual track act to promote the development of regenerative and cell therapy products. This qualitative study used purposive sampling to recruit sixteen experts (Twelve respondents from medical institutions and four respondents from the industry) to understand their perspectives on one of the regulatory tracks which governs the medical use of cell technologies and challenges regarding its implementation. Semi-structured interviews were conducted, transcribed, coded and thematically analyzed. Three major themes emerged from the analysis: 1) Perceptions of the “Special Regulation for Cell Therapy” 2) Emerging issues and controversies on the medical use of cell technologies in private clinics, and 3) Challenges impeding the clinical innovation of cell technologies. As reported by the experts, it was clear that the special regulation for cell therapy was aimed at legalizing the clinical use of cell therapy in a similar fashion to an evidence-based pathway, to promote clinical innovation, ensure manufacturing consistency, and improve oversight on cell-based therapies. Thus, the regulation addresses the issues of safety concerns, patient’s access and stem cell tourism. However, the limited approved cell techniques, quality control during cell processing, time, and criteria used in evaluating applications in addition to the need to develop evidential standards for clinical evidence are some of the difficulties faced. Thus, policy interventions on funding, educational resources, training, and regulatory clarity addressing these challenges may positively impact clinical innovation of cell therapy in Taiwan.

Professional integrity in maternal – fetal innovation and research: an essential component of perinatal medicine

Objectives Clinical innovation and research on maternal–fetal interventions have become an essential for the development of perinatal medicine. In this paper, we present an ethical argument that the professional virtue of integrity should guide perinatal investigators. Methods We present an historical account of the professional virtue of integrity and the key distinction that this account requires between intellectual integrity and moral integrity. Results We identify implications of both intellectual and moral integrity for innovation, research, prospective oversight, the role of equipoise in randomized clinical trials, and organizational leadership to ensure that perinatal innovation and research are conducted with professional integrity. Conclusions Perinatal investigators and those charged with prospective oversight should be guided by the professional virtue of integrity. Leaders in perinatal medicine should create and sustain an organizational culture of professional integrity in fetal centers, where perinatal innovation and research should be conducted.

Creating a Healthcare Entrepreneurship Teaching Program for Medical Students

Introduction: The future of healthcare hinges on effective adoption of innovative solutions. Arguably, physicians are ideally positioned to propel clinical innovation given their firsthand experience with healthcare challenges; however, physicians often lack the necessary skills in innovation development and implementation methodology. The gap is partly a result of the paucity of exposure to innovation and entrepreneurship concepts within medical education and postgraduate training. To address this gap, the University of Toronto’s distributed medical education campus in Mississauga created a novel teaching initiative designed to impart themes of healthcare entrepreneurship to early stage medical learners. Methods: To inform the design of the program, the authors conducted a series of semi-structured interviews with key stakeholders, including physician entrepreneurs, innovation leaders, curriculum specialists and medical students. Using thematic analysis, key recommendations were extracted regarding learning objectives, approach to program delivery, and anticipated outcomes. A well-established entrepreneurial teaching model, the MaRS Entrepreneurship Framework, was adapted to frame the curricular content to the needs of medical learners. The resulting educational product consisted of six sessions, taught by subject matter experts, which outlined a methodological approach to the development of a medical start-up as a means of launching an innovation. Results: From November 2019 to May 2020, six sessions were held with a total of 37 unique attendees. The authors found that the series generated interest in entrepreneurship among medical students while fostering an appreciation for the basic principles of entrepreneurship. Conclusion: The next stage involves further program evaluation to guide the next iteration of the program. Potential avenues for growth include delivering the series virtually to support greater student accessibility. Future considerations include incorporating entrepreneurship into core undergraduate medical curricula and creating a dual degree program in medicine and entrepreneurship that cater to students with a deep interested in the field of healthcare entrepreneurship. Disclosure: The authors have no conflict of interest to declare. As all data were completely anonymized and no patients were involved, this was not reviewed by an ethics board.