Introduction: Optic neuritis leads to degeneration of retinal ganglion cells whose axons form the optic nerve. The standard treatment is a methylprednisolone pulse therapy. This treatment slightly shortens the time of recovery but does not prevent neurodegeneration and persistent visual impairment. In a phase II trial performed in preparation of this study, we have shown that erythropoietin protects global retinal nerve fibre layer thickness (RNFLT-G) in acute optic neuritis; however, the preparatory trial was not powered to show effects on visual function.
Background The coronavirus disease 2019 (COVID-19) pandemic is a threat to ongoing clinical trials necessitating regular face-to-face, in-person meetings, particularly in participants with a high risk of complications. Guidance on how to handle and safely continue such trials is lacking. Chronically ill elderly individuals require—in addition to protection from infection—regular physical exercise and social contact to remain healthy. Solutions on how to handle these conflicting necessities are needed. The ENTAIER-randomised controlled trial was investigating the influence of mindful movements on fall risk, fear of falling, mobility, balance, life quality, and other outcomes. The study population was planned to comprise of 550 chronically ill elderly individuals with a high risk of falling. The movements were regularly performed in coached groups over 6 months. After the trial began, COVID-19 lockdowns stopped all in-person meetings, and it was expected that the limitations of this pandemic would continue for a long term. Therefore, the exercise programme, which involved complex movements and was typically conducted face-to-face in groups, had to be substituted by a telemedicine programme within a short timeframe. The objectives, therefore, were to identify challenges and tasks that could to be resolved and steps that could to be taken to achieve high-quality, efficacy, safety, and enable human encounter and motivation. Methods We proceeded with four steps: 1) A literature review on the quality and feasibility issues of telemedicine in general, and specifically, in exercise training in elderly individuals. 2) Participation in two international telemedicine task forces on integrative medicine, particularly, mind–body medicine. 3) Interviews with study therapists, (for practical purposes, eurythmy therapists and Tai Chi teachers are summarized here as therapists) personnel, and international experts on providing mindful movement exercises and other physiotherapies via live telecommunication technology, and with scientists and patient representatives. 4) Final evaluation by the core trial team and subsequent planning and implementation of changes in the trial organisation. Results Various tasks and challenges were identified: for the technical equipment for therapists and patients; for the ability of therapists and trial participants to adequately manage the technology and telemedicine intervention; the reservations and concerns about the technology among therapists and participants; safety and data protection in using the technology; and study design. The two major options found on how to continue the trial in the COVID-19 situation were a complete switch to telemedicine and a partial switch in the form of risk management implemented into the former design. Conclusions The management of an ongoing clinical trial in a national or international crisis with a minimum of available time and extra financial resources, alongside with two checklists on steps and procedures for trial continuation and telemedicine implementation, may be informative for other researchers or healthcare providers faced with similar challenges and making similar decisions in the current situation or similar future scenarios. Trail registration www.drks.de. DRKS00016609. Registered July 30, 2019.
BackgroundThe need for documentation in cartilage defects is as obvious as in other medical specialties. Cartilage defects can cause significant pain, and lead to reduced quality of life and loss of function of the affected joint. The risk of developing osteoarthritis is high. Therefore, the socioeconomic burden of cartilage defects should not be underestimated.ObjectiveThe objective of our study was to implement and maintain a registry of all patients undergoing surgical treatment of cartilage defects.MethodsWe designed this multicenter registry for adults whose cartilage defects of a knee, ankle, or hip joint are treated surgically. The registry consists of two parts: one for the physician and one for the patient. Data for both parts will be gathered at baseline and at 6-, 12-, 24-, 36-, 60-, and 120-month follow-ups.ResultsTo date, a wide range of German, Swiss, and Austrian trial sites are taking part in the German Cartilage Registry, soon to be followed by further sites. More than 2124 (as of January 31, 2016) cases are already documented and the first publications have been released.ConclusionsThe German Cartilage Registry addresses fundamental issues regarding the current medical care situation of patients with cartilage defects of knee, ankle, and hip joints. In addition, the registry will help to identify various procedure-specific complications, along with putative advantages and disadvantages of different chondrocyte products. It provides an expanding large-scale, unselected, standardized database for cost and care research for further retrospective studies.Trial RegistrationGerman Clinical Trials Register: DRKS00005617; https://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005617 (Archived by WebCite at http://www.webcitation.org/6hbFqSws0)
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