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C L Meinert

Publications and source records attributed to C L Meinert.

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Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards.

OBJECTIVE: --To investigate factors associated with the publication of research findings, in particular, the association between "significant" results and publication. DESIGN: --Follow-up study. SETTING: --Studies approved in 1980 or prior to 1980 by the two institutional review boards that serve The Johns Hopkins Health Institutions--one that serves the School of Medicine and Hospital and the other that serves the School of Hygiene and Public Health. POPULATION: --A total of 737 studies were followed up. RESULTS: --Of the studies for which analyses had been reported as having been performed at the time of interview, 81% from the School of Medicine and Hospital and 66% from the School of Hygiene and Public Health had been published. Publication was not associated with sample size, presence of a comparison group, or type of study (eg, observational study vs clinical trial). External funding and multiple data collection sites were positively associated with publication. There was evidence of publication bias in that for both institutional review boards there was an association between results reported to be significant and publication (adjusted odds ratio, 2.54; 95% confidence interval, 1.63 to 3.94). Contrary to popular opinion, publication bias originates primarily with investigators, not journal editors: only six of the 124 studies not published were reported to have been rejected for publication. CONCLUSION: --There is a statistically significant association between significant results and publication.

Academic Medical Centers

Data integrity.

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Clinical Trials as Topic

Identification of meta-analyses. The need for standard terminology.

Our efforts to identify published articles describing meta-analyses of clinical trials illustrate the need for standard terminology to facilitate retrieval. We found 119 articles describing meta-analyses and eligible for inclusion in MEDLINE, and yet when we searched MEDLINE, using strategies based on textwords and medical subject headings (MeSH), only 48% of the 119 articles were identified. Sixty-eight (57%) of the 119 articles contained at least one of the terms "meta-analysis," "pooling," or "overview" in the title or abstract. The importance of meta-analyses in the evaluation of medical treatments argues for more disciplined use of a specific term in order to facilitate identification of articles. The fact that the National Library of Medicine has started in 1989 to index articles describing meta-analyses using the MeSH META-ANALYSIS underscores this argument.

Clinical Trials as Topic

Infant stimulation curriculum for infants with cerebral palsy: effects on infant temperament, parent-infant interaction, and home environment.

To assess the effects of intervention in cerebral palsy, 48 infants 12 to 19 months of age, with mild to severe spastic diplegia, were randomly assigned to receive either 6 months of infant stimulation followed by 6 months of physical therapy (test group) or 12 months of neurodevelopmental physical therapy (contrast group). The infant stimulation protocol consisted of cognitive, motor, sensory, and language activities. Outcome was assessed after 12 months by using Carey Infant Temperament Questionnaire subscores (activity, rhythmicity, adaptability, approach, threshold, intensity, mood, distractibility, and persistence); Roth Mother-Child Relationship Evaluation subscores (acceptance, overprotection, overindulgence, rejection); and Home Observation for Measurement of the Environment subscores (maternal responsiveness, avoidance of restriction and punishment, organization of environment, play materials, maternal involvement, and variety of daily stimulation). Motor and cognitive outcomes suggesting advantage for the test group have been reported previously. After 12 months of intervention, mothers with infants in the contrast group showed a greater improvement in emotional and verbal responsiveness as measured by the Home Observation for Measurement of the Environment (mean score change in control group = 1.2, test group = 0.3 P less than .04). None of the 19 other measures differed significantly between treatment groups in change from baseline. This study demonstrates no short-term systematic effect on temperament, maternal-infant interaction, or home environment attributable to the inclusion of an infant stimulation curriculum in an intervention program for infants with spastic diplegia. It suggests that motor and cognitive advantages associated with infant stimulation are not mediated by measurable changes in the psychosocial variables studied.

Cerebral Palsy

Communications: Should mechanisms be established for sharing among clinical trial investigators experiences in handling problems in design, execution, and analysis? Methodology: the case for improved communications.

Despite their long history, the number that are in operation now, and the current level of expenditures on them, clinical trials have not been the focus of sufficient methodologic research. The paucity of metholologic explorations is further aggravated by the constraints on communications regarding methodology. Those individuals working in the area of clinical trials need to establish some professional identity with the field. Methodology in the areas of design and management of clinical trials needs to be stimulated, perhaps through special requests for applications (RFAs) and requests for proposals (RFPs). Communications could be improved by the establishments of a professional society, the development of an appropriate journal, and establishment of national training and information centers for clinical trials.

Clinical Trials as Topic

A plea for a discipline of health and medical evaluation.

There is an expanding need for quantitative information to evaluate health and medical care procedures. Existing methods for designing and carrying out evaluation studies need to be improved to provide better techniques for answering questions on efficacy of health and medical procedures, and in providing a more adequate information base on which to set healthy policy. This paper reviews some of the problems in the design and conduct of evaluation research, and makes a plea for creation of a special discipline to support and develop the field of health and medical care evaluation.

Clinical Trials as Topic