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Bayesian Approaches in the Regulation of Medical Products
Published in Mani Lakshminarayanan, Fanni Natanegara, Bayesian Applications in Pharmaceutical Development, 2019
An adaptive design is defined as a clinical study design that allows for prospectively planned modifications based on accumulating study data without undermining the study’s integrity and validity [22]. Adaptive designs have been increasingly adopted because they usually make trials more efficient.
Bottom-Up Cell Culture Models to Elucidate Human In Vitro Biomarkers of Infection
Published in Raquel Cumeras, Xavier Correig, Volatile organic compound analysis in biomedical diagnosis applications, 2018
Michael Schivo, Mitchell M. McCartney, Mei S. Yamaguchi, Eva Borras, Cristina E. Davis
Clearly, the field of non-invasive breath diagnostics is undergoing a rapid transition from a nascent field of inquiry into a more developed field of research that goes beyond simple phenomenology. Early studies in the field focused on clinical trials and untargeted biomarker discovery, but this approach is sensitive to artifacts and confounding effects in the clinical study design. Due to the untargeted nature of this biomarker search paradigm, these artifacts are very difficult to identify. Extremely large clinical trials with high numbers of human subjects are needed to fully verify these biomarker identifications via this method. It is not always a practical model to generate candidate biomarkers for either diagnostic or therapy approaches.
Case reports in dysphagia
Published in Margaret Walshe, Maggie-Lee Huckabee, Clinical Cases in Dysphagia, 2018
Margaret Walshe, Maggie-Lee Huckabee
Gagnier et al. (2013, p. 223) suggest that ‘case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or inform clinical study design’. There are reporting standards for most types of studies. Templates for these are published on the Equator Network (see www.equator-network.org). Case reports are no different. Some journals, such as the British Medical Journal, have specific guidelines on writing case reports. These must obviously be followed when submitting manuscripts to these journals. Many journals also require a patient consent form but all attempts to protect the person’s identity must be made with no identifying information in the case report.
Effects of An Occupational Therapy Memory Strategy Education Group Intervention on Irish Older Adults’ Self-Management of Everyday Memory Difficulties
Published in Occupational Therapy In Health Care, 2019
Áine Coe, Mary Martin, Tadhg Stapleton
A quasi-experimental one -group pretest post-test prospective clinical study design was utilized in the study (Portney & Watkins, 2009). Marsden and Torgerson (2012 p. 592) highlight that quasi-experiments can determine “the promise” of an intervention when the intervention in question is in its development phase. This type of study design was considered the most appropriate and feasible for this research, as the intervention was a new service initiative in the development phase. Baseline data was collected prior to intervention for clients recruited to the study (time point one; TP1), and was repeated two weeks after the clients completed the six week intervention (time point two; TP2), with final follow-up assessments completed at 3-months post intervention (time point three; TP3).
Designing medical technology for resilience: integrating health economics and human factors approaches
Published in Expert Review of Medical Devices, 2018
Simone Borsci, Ijeoma Uchegbu, Peter Buckle, Zhifang Ni, Simon Walne, George B. Hanna
In line with these initiatives, HERD MedTech may potentially bring awareness among experts regarding the usefulness of integrated research at early stages of device design. This framework may be useful to experts in pre- and post-market assessment of MT including human factors, health economists, designers, health-care professional and experts in health technology, and clinical study design. In addition, HERD MedTech could potentially be the basis for the development of a common framework of assessment to improve market access processes for MT. The hope is that this framework will lead to a discussion to future revision of the international standards (e.g. IEC 62366-1) as well as national guidance for HTA. The development of the approach advance in this article was informed by four years of industry-facing academic research that aimed to generate evidence to inform the adoption of MT into the UK’s national health system. It has incorporated research perspectives in human factors analysis, health economic evaluation, decision analysis, and clinical practice.
Visual Pathway Degeneration in Chemotherapy-Related Neurotoxicity: A Review and Directions for Future Research
Published in Neuro-Ophthalmology, 2020
David E. Anderson, Sarah A. Holstein, Sachin Kedar
Improvements in clinical study design will be necessary to carry the state of the science forward. Studies reviewed here were either retrospective34,35 or prospective with multiple cancer diagnoses38,39 and chemotherapy protocols.37,39 Future research will benefit by using prospective studies of patients with homogeneous cancer diagnoses. Furthermore, including multiple time points during and after treatment will improve the resolution of dose-dependent and long-term changes in retinal structure and function. Focusing on a single chemotherapy protocol, rather than multiple protocols with a common agent, will improve clinical relevance and directions for future research to isolate neurotoxic agents.