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Trial Registries (trial + registry)
Selected AbstractsProspective Registration of Clinical Trials in India: Strategies, Achievements & ChallengesJOURNAL OF EVIDENCE BASED MEDICINE, Issue 1 2009Prathap Tharyan Abstract Objective This paper traces the development of the Clinical Trial Registry-India (CTRI) against the backdrop of the inequities in healthcare and the limitations in the design, conduct, regulation, oversight and reporting of clinical trials in India. It describes the scope and goals of the CTRI, the data elements it seeks and the process of registering clinical trials. It reports progress in trial registration in India and discusses the challenges in ensuring that healthcare decisions are informed by all the evidence. Methods A descriptive survey of developments in clinical trial registration in India from publications in the Indian medical literature supplemented by firsthand knowledge of these developments and an evaluation of how well clinical trials registered in the CTRI up to 10 January, 2009 comply with the requirements of the CTRI and the World Health Organization's International Clinical Trial Registry (WHO ICTRP). Results Considerable inequities exist within the Indian health system. Deficiencies in healthcare provision and uneven regulation of, and access to, affordable healthcare co-exists with a large private health system of uneven quality. India is now a preferred destination for outsourced clinical trials but is plagued by poor ethical oversight of the many trial sites and scant information of their existence. The CTRI's vision of conforming to international requirements for transparency and accountability but also using trial registration as a means of improving trial design, conduct and reporting led to the selection of registry-specific dataset items in addition to those endorsed by the WHO ICTRP. Compliance with these requirements is good for the trials currently registered but these trials represent only a fraction of the trials in progress in India. Conclusion Prospective trial registration is a reality in India. The challenges facing the CTRI include better engagement with key stakeholders to ensure increased prospective registration of clinical trials and utilization of existing legislative opportunities to complement these efforts. [source] Immunosuppressive treatments for immunoglobulin A nephropathy: A meta-analysis of randomized controlled trialsNEPHROLOGY, Issue 4 2004Review Article SUMMARY: Immunoglobulin A (IgA) nephropathy is a worldwide disease that causes end-stage kidney disease (ESRD) in up to 15,20% of affected patients within 10 years from the apparent onset of disease and in up to 30,40% of individuals within 20 years from diagnosis. No specific treatment has been established and there is wide variation in current practice. This systematic review evaluates the use of immunosuppressive agents to treat patients with IgA nephropathy. The Cochrane Renal Group Specialized Register, Cochrane Controlled Trial Registry, MEDLINE, EMBASE and article reference lists were searched for randomized or quasi randomized trials. Two independent reviewers assessed studies for inclusion criteria (biopsy proven IgA nephropathy, randomized trial, use of immunosuppressive agents) and extracted data regarding the effects of immunosuppressive agents on ESRD, doubling of serum creatinine, glomerular filtration rate, urinary protein excretion and side-effects. Data were analysed with a random effects model. The published trials were few (13 trials, 623 patients) and were generally of poor quality. Compared with placebo, steroids were associated with a lower risk of progression to ESRD (six trials, 341 patients, RR 0.44, 95% CI 0.25,0.80) and lower end-of-trial proteinuria (six trials, 263 patients, weighted mean difference (WMD) ,0.49 g/day, 95% CI ,0.25 to ,0.72). Treatment with alkylating agents significantly reduced end of treatment proteinuria (two trials, 122 patients, WMD ,0.94, 95% CI ,0.46 to ,1.43). Although the optimal management of patients with IgA nephropathy remains uncertain because of limitations with the existing published data, immunosuppressive agents are a promising strategy and should be investigated further. [source] Nurse-led vs. conventional physician-led follow-up for patients with cancer: systematic reviewJOURNAL OF ADVANCED NURSING, Issue 4 2009Ruth Lewis Abstract Title.,Nurse-led vs. conventional physician-led follow-up for patients with cancer: systematic review. Aim., This paper is a report of a systematic review of the effectiveness and cost-effectiveness of nurse-led follow-up for patients with cancer. Background., As cancer survivorship increases, conventional follow-up puts a major burden on outpatient services. Nurse-led follow-up is a promising alternative. Data sources., Searches were conducted covering a period from inception to February 2007 of 19 electronic databases, seven online trial registries, five conference proceedings reference lists of previous reviews and included studies. Review methods., Standard systematic review methodology was used. Comparative studies and economic evaluations of nurse-led vs. physician-led follow-up were eligible. Studies comparing different types of nurse-led follow-up were excluded. Any cancer was considered; any outcome measure included. Results., Four randomised controlled trials were identified, two including cost analyses. There were no statistically significant differences in survival, recurrence or psychological morbidity. One study showed better HRQL measures for nurse-led follow-up, but one showed no difference, two showed a statistically significant difference for patient satisfaction, but two did not. Patients with lung cancer were more satisfied with nurse-led telephone follow-up and more were able to die at home. Patients with breast cancer thought patient-initiated follow-up convenient, but found conventional follow-up more reassuring. One study showed the cost of nurse-led follow-up to be less than that of physician-led follow-up, but no statistical comparison was made. Conclusion., Patients appeared satisfied with nurse-led follow-up. Patient-initiated or telephone follow-up could be practical alternatives to conventional care. However, well-conducted research is needed before equivalence to physician-led follow-up can be assured in terms of survival, recurrence, patient well-being and cost-effectiveness. [source] Gynaecological surgery from art and craft to science?AUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 2 2009Neil Philip JOHNSON Randomised controlled trials are applied more readily to medical than surgical interventions. There are even more barriers to randomised trials of surgical interventions than to other randomised trials. These include reluctance among surgeons to undertake trials (owing to concern over expressing equipoise, surgical training and surgical learning curve issues, restrictions of funding and time for research, even financial conflict of interest), reluctance of patients to participate in surgical trials owing to fears over ,experimental surgery', failure of randomised trials to detect rare surgical complications and the almost universal failure of those conducting surgical trials to examine important long-term outcomes. Rapid advances in surgical fields mean that new surgical techniques are rapidly superseded and clinical questions surrounding new techniques may linger only until the next new technique becomes available. Nonetheless randomised controlled trials remain the cornerstone of evaluating the effectiveness of surgical interventions. Genuine progress has been made in this field. However, large multicentre collaborative randomised trials that have been prospectively defined in trial registries will be required in the future to answer the important clinical questions regarding gynaecological surgical interventions. [source] Does the Addition of Dexamethasone to Standard Therapy for Acute Migraine Headache Decrease the Incidence of Recurrent Headache for Patients Treated in the Emergency Department?ACADEMIC EMERGENCY MEDICINE, Issue 12 2008A Meta-analysis, Systematic Review of the Literature Abstract Objectives:, Neurogenic inflammation is thought to play a role in the development and perpetuation of migraine headache. The emergency department (ED) administration of dexamethasone in addition to standard antimigraine therapy has been used to decrease the incidence of recurrent headaches at 24 to 72 hours following evaluation. This systematic review details the completed trials that have evaluated the use of dexamethasone in this role. Methods:, The authors searched MEDLINE, EMBASE, CINAHL, LILACS, recent emergency medicine scientific abstracts, and several prepublication trial registries for potential investigations related to the research question. The authors included studies that incorporated randomized, double-blind, placebo-controlled methodology and that were performed in the ED. A fixed-effects and random-effects model was used to obtain summary risk ratios (RRs) and 95% confidence intervals (CIs) for the self-reported outcome of moderate or severe headache on follow-up evaluation. Results:, A pooled analysis of seven trials involving 742 patients suggests a modest but significant benefit when dexamethasone is added to standard antimigraine therapy to reduce the rate of patients with moderate or severe headache on 24- to 72-hour follow-up evaluation (RR = 0.87, 95% CI = 0.80 to 0.95; absolute risk reduction = 9.7%). The treatment of 1,000 patients with acute migraine headache using dexamethasone in addition to standard antimigraine therapy would be expected to prevent 97 patients from experiencing the outcome of moderate or severe headache at 24 to 72 hours after ED evaluation. The sensitivity analysis yielded similar results with sequential trial elimination, indicating that no single trial was responsible for the overall result. Adverse effects related to the administration of a single dose of dexamethasone were infrequent, mild, and transient. Conclusions:, These results suggest that dexamethasone is efficacious in preventing headache recurrence and safe when added to standard treatment for the management of acute migraine headache in the ED. [source] | ||||||||||