No abstract available.
Multicenter Studies as Topic

Humans ; Multicenter Studies as Topic

Background: Antimicrobials are drugs that are often misused and inappropriate antimicrobial prescribing often results in poor clinical outcome and drug resistance. Monitoring and regulation of antimicrobial use is currently being done by the Department of Health through the Antimicrobial Stewardship (AMS) Program. There is a need to determine the factors that affect successful implementation of an AMS program in private hospitals in the Philippines. This study was conducted to identify the enablers and potential barriers in implementing an AMS program in nine (9) private hospitals. Methodology: A concurrent mixed methods design was used to assess various stakeholders’ (physicians, administrators, other AMS members) perceptions of existing or proposed AMS programs, and to identify barriers and enablers in their implementation. Quantitative data were collected using self-administered survey questionnaire to assess clinician’s acceptance of AMS programs. Qualitative data were collected through semi-structured one-on-one interviews of clinicians and other AMS personnel and focus group discussions (FGD) of selected clinician groups. Data were gathered from October 2018 to October 2019. Results: 409 clinicians were surveyed, 52 were interviewed and 46 sat for 13 sessions of FGDs. Overall, the survey established that physicians were well aware of antimicrobial resistance problem. Majority of the clinicians indicated general agreement with the currently practiced antimicrobial protocols in their hospitals and with the AMS program. However, there were disagreements in perceptions with how antimicrobial restrictions impair prescribing practices and overuse of the same. These responses were strong points of discussion during the Key Informant Interviews (KII) and FGDs. All respondents were amenable with the institutionalization of an AMS program in their hospitals. The hospital leadership’s commitment was determined to be the key enabler of a successful AMS program’s implementation. Barriers identified for hospitals with existing AMS programs were: lack of dedicated staff, resistance and/or non-cooperation of physicians, lack of support from non-medical departments, and inadequate cooperation between hospital personnel. Barriers identified, regardless of the status of the AMS programs were: deficiency in knowledge with developing and implementing an AMS program, inadequate information dissemination, unavailability of an IT-based monitoring for antibiotic use, and the influence of pharmaceutical companies on stakeholders with regards to antimicrobial use. Conclusion Similar enablers and barriers to a successful implementation of an AMS program were seen in the different hospitals. A hospital leadership’s commitment was determined to be the key enabler. The success or failure of any AMS program appears to depend on physician understanding, commitment and support for such a program. By involving the main players in an AMS program- the hospital administrators, clinicians and other key members, perceived barriers will be better identified and overcome, and enablers will help allow a successful implementation of an AMS program. This multi-center study was funded by Philippine Council on Health Research and Development ( PCHRD) and Pediatric Infectious Disease Society of the Philippines ( PIDSP) and was conducted by the PIDSP Research Committee.
Physicians ; Multicenter Studies as Topic

Recently, multicenter clinical trials have been getting more popular inside and outside of the country. The disease pattern of our country is somewhat different from that of western countries in terms of its incidence, clinical feature. Therefore, the results of clinical studies in US or European countries cannot be properly applied without consideration of trial design features and intertrial comparisons. Therefore, the conduct of multicenter trial with our own population is necessary. Well organized multicenter trials having competitive power will make it possible to develop new treatment modalities, frame a reasonable policies for its clinical applications and ultimately contribute to improve national healthcare services.
Delivery of Health Care ; Incidence ; Multicenter Studies as Topic

Recently, multicenter clinical trials have been getting more popular inside and outside of the country. The disease pattern of our country is somewhat different from that of western countries in terms of its incidence, clinical feature. Therefore, the results of clinical studies in US or European countries cannot be properly applied without consideration of trial design features and intertrial comparisons. Therefore, the conduct of multicenter trial with our own population is necessary. Well organized multicenter trials having competitive power will make it possible to develop new treatment modalities, frame a reasonable policies for its clinical applications and ultimately contribute to improve national healthcare services.
Delivery of Health Care ; Incidence ; Multicenter Studies as Topic

No abstract available.
Acne Vulgaris* ; Female* ; Humans ; Multicenter Studies as Topic*

Biomedical Research ; Humans ; Multicenter Studies as Topic ; Vestibular Diseases ; diagnosis ; therapy

Biomedical Research ; Child ; Humans ; Multicenter Studies as Topic ; Pediatrics

OBJECTIVETo study the center effect discrepancy in the multi-center clinical trials.

METHODSTwo groups of data collected from the multi-center clinical trials were used. Data were processed by covariance analysis and Meta-analysis.

RESULTSIn the covariance analysis, the discrepancy of the center effect values indicated statistical significance. Through Meta-analysis on fixed effect model, the discrepancy in one heterogeneity test showed no statistical significance (P > 0.05) while the inter-group discrepancy of the merged effect values drawn from analysis based on fixed effect model having statistical significance (P < 0.05). In the random effect model, the discrepancy in one heterogeneity test showed statistical significance (P < 0.05) while the inter-group discrepancy of the merged effect values drawn from analysis based on random effect model having no statistical significance (P > 0.05).

CONCLUSIONSStudies on multi-center random controlled clinical trials, when statistical significance was found in the interaction discrepancy between the inter-center and the center-group relation, the merged effect values should be compared and analyzed by an appropriate statistic model based on the heterogeneous test results from the Meta-analysis. However, if the result from covariance analysis and the one from Meta-analysis did not agree to each other, the results drawn from the Meta-analysis were reliable.

Objectives: To analyze the current development status of gastric cancer (GC) randomized controlled trials (RCT) between 2000 and 2019, and to review the basic characteristics of published RCT. Methods: ClinicalTrials.gov was searched for phase 3 or 4 RCT conducted between January 2000 and December 2019 with the keyword "gastric cancer", and the development trend of different types of RCT during different time periods was described. Basic features of registered RCT such as intervention, study area, single-center or multicenter, sample size, and funding were presented. PubMed and Scopus databases were searched to judge the publication status of studies completed until June 2016. The adequacy of the report was estimated by the Consolidated Standards of Reporting Trials (CONSORT) checklist. Design flaws were evaluated by Cochrane tool and/or whether a systematic literature review was cited. The data was analyzed by χ² test or Fisher exact test. Results: There were 262 RCT including in the present study. The number of GC-RCT registered on ClinicalTrials.gov had been on the rise from 1 case in 2000 to 30 cases in 2015. The proportion of RCT associated with targeted therapy or immunotherapy increased from 0 during 2000-2004 to 37.1% (36/97) during 2015-2019. The RCT registered in Asia was 191 cases, while that in non-Asia region was 71 cases. The proportion of multi-center RCT from non-Asia was higher than that from Asia (70.4% (50/71) vs. 50.3% (96/191), χ²=8.527, P=0.003). The proportion of RCT published was 59.1% (81/137). Among the published RCT, 65 (80.2%) studies were reported adequately, but 63 (77.8%) studies had avoidable design limitations. Conclusions: Targeted therapy and immunotherapy have become research hotspots in the treatment of GC. At present, there are inadequate multicenter RCT in Asia, and the publication rate of RCT is low. A considerable number of published RCT are reported inadequately and have avoidable design flaws.
Humans ; Multicenter Studies as Topic ; Randomized Controlled Trials as Topic ; Stomach Neoplasms/therapy*