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Biomedical subjects

S E Margitić

Publications and source records attributed to S E Margitić.

5 recordsLinked to original sources
PubMed1995

Lessons learned from a prospective meta-analysis.

OBJECTIVE: To describe the unique aspects of and the lessons learned in planning and conducting a pooled analysis of multiple trials evaluating interventions to reduce functional decline in hospitalized older persons. Specific examples from the Hospital Outcomes Project for the Elderly (HOPE) meta-analysis are discussed. DESIGN: A prospective meta-analysis (PMA) that compiled and pooled data from concurrently conducted clinical trials testing related but distinct interventions. SETTING: The Data Coordinating Center for the prospective meta-analysis coordinated the collection and analysis of common outcome data from five university-affiliated hospitals and one community hospital conducting the clinical trials. PARTICIPANTS: Acutely ill hospitalized elderly participants at least 65 to 75 years old. INTERVENTIONS: Treatments being evaluated included exercise, physical therapy, a multidisciplinary geriatric care unit, a multidisciplinary in-hospital intervention with post-discharge care, a nursing-based geriatric care program, and a program to improve detection and evaluation of delirious patients. CONCLUSION: The prospective meta-analysis provides selected advantages over independently conducted clinical trials and retrospective meta-analyses. It does, however, pose special design and operational challenges that must be addressed well before initiation of the individual trials. Specific issues of concern include: maintaining scientific integrity of both the individual trials and the PMA; reaching consensus on PMA goals, what data to collect, how and when to collect them and how to maintain uniformly high quality data across all sites; defining the role of the Data Coordinating Center in a multicenter project that utilizes different trials and protocols; and establishing policies concerning analyses of the pooled data, publication of pooled analyses, and ownership of the pooled database.

Aged↗
PubMed1993

Hospital Outcomes Project for the Elderly (HOPE): rationale and design for a prospective pooled analysis.

OBJECTIVE: To describe a collaborative investigation that is based on a series of six clinical studies aimed at reducing functional decline in the acutely-ill hospitalized elderly. DESIGN: A prospective, multicenter pooled analysis project involving collection of a common set of data from a group of related but distinct intervention trials with similar objectives. SETTING: Five university-affiliated hospitals and one community hospital. PARTICIPANTS: Elderly patients (age minimums from 65 to 75 years) admitted for a range of acute illnesses. INTERVENTIONS: Site-specific interventions include exercise and physical therapy; developing and implementing methods to improve detection and evaluation of delirious patients; a multidisciplinary geriatric care unit; a multidisciplinary intervention implemented in-hospital that includes some post-discharge care; and a nursing-centered geriatric care program. MAIN OUTCOME MEASURE: Functional status. CONCLUSION: The prospective, multicenter design of the Hospital Outcomes Project for the Elderly (HOPE) provides an innovative approach for analysis of hospital outcomes in the elderly. Although differences in study populations and interventions exist, qualitative comparisons across sites will enhance generalizability and will provide a great opportunity to examine consistency among the sites. The HOPE pooled analysis project will impart greater statistical power to detect the primary and secondary outcomes compared with previous single-center trials that have assessed interventions related to functional decline in the hospitalized elderly.

Activities of Daily Living↗
PubMedDate not supplied

The recruitment of African-Americans to cancer prevention and control studies.

BACKGROUND: African-Americans have the highest overall age-adjusted cancer incidence and mortality rates of any population group in the United States. Despite this fact, this group remains underrepresented in cancer prevention and control research studies, primarily because most recruitment strategies result in limited access to African-American populations. METHODS: As part of three large-scale cancer prevention and control studies, effective strategies for recruiting African-American participants were developed and implemented. RESULTS: Eight strategies have been identified as successful recruitment strategies for involving African-Americans in cancer prevention and control studies. Utilizing these strategies resulted in recruiting a representative number of African-American participants, in relation to the local population, into the three studies. CONCLUSIONS: African-Americans can be recruited to participate in cancer control and prevention studies if plans include special strategies targeted to addressing unique barriers, beliefs, and concerns.

Adult↗
PubMedDate not supplied

Ten commandments of successful trial management.

A well-designed, adequately funded clinical trial based on sound science and conducted by experienced investigators and staff can falter if participating trial clinics are not managed well. Ten commandments for successful trial clinic management address key organizational and operational issues. Commandment I: Thou shalt know and follow thy rules. Commandment II: Thou shalt know and fulfill thy roles. Commandment III: Thou shalt meet thy commitments. Commandment IV: Thou shalt collaborate. Commandment V: Thou shalt communicate. Commandment VI: Thou shalt document. Commandment VII: Thou shalt honor thy participants. Commandment VIII: Thou shalt keep thy participants' secrets. Commandment IX: Thou shalt revere thy data. Commandment X: Thou shalt know and accept thy limitations. This report puts these commandments into context by providing concrete examples in the clinical trial setting. These commandments could serve as guidelines to the spectrum of personnel involved in the operations of a trial clinic, namely, principal investigators and co-investigators, trial coordinators, data managers, technicians, administrators, and support staff.

Clinical Trials as Topic↗