Possible progress and unresolved conflicts resulting from guidelines on good epidemiologic practices

Article Abstract:

The implementation of the good epidemiologic practices (GEP) guidelines is reviewed and raises many questions. Will the introduction of GEP, and the associated increase in the necessary quality assurance, quality control, documentation, archiving requirements, and other additional imposts increase the quality of occupational epidemiology? Will the added requirements subtract from the already diminished study dollars? Guidelines that are well intended to help the study process frequently become rules that must be followed. Many problems arise from the implementation of GEPs. For example, release of data sets for public use frequently impinges on the individuals' rights to privacy. These infringements could diminish the pool of participants. Release of data without personal descriptors may not be sufficient to hide the individuals' identities, while it may eliminate the value of the information. Data sharing, access, and archiving requirements present concerns. How will the data be stored, and where? Storage facilities and the storage medium must be sufficient to preserve the integrity of the information. Should studies be low-power, using smaller subject numbers, or high-power, using large cohorts? Rigid adherence to guidelines can diminish the quality of the study, but departure from the guidelines can deny its quality. Guidelines should not, in other words, be transformed into a rigid, irrevocable set of rules, as this can stifle investigations and valid inquiry. Time and usage will decide the benefits or disadvantages of the GEP. (Consumer Summary produced by Reliance Medical Information, Inc.)

Methods

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Managing the quality and conduct of epidemiologic studies

Article Abstract:

The quality of epidemiologic study design has rarely been considered as a separate topic in the medical literature. While some studies critique particular components of the design, the methods used in the treatment process, the manner of reporting results, or the data analysis process, there has been a notable lack of review of the total process, including sponsorship of the studies, who conducts the studies, and how the data is amassed, reviewed, and analyzed. Epidemiologic studies and analyses are gaining greater stature and playing more important roles as the foundations of health policy. Recent federal legislation governing environmental matters, issues, toxins, testing, etc., has required epidemiologic studies to maintain good laboratory practices (GLPs). The inclusion of GLPs as a criterion for the acceptance of toxicological studies was feared by the toxicologists as an unnecessary restraint, but these fears proved groundless. These requirements contributed to quality reporting conducted in a manner permitting comparative analyses. The epidemiologic study was the subject of a conference at which the introduction of good epidemiologic practices (GEPs) was proposed. These GEPs are intended to establish minimum, but not sufficient, practices and procedures. They provide for the quality and integrity of data produced, the resultant analyses, and the outcome decisions. The recommended format of epidemiologic study, consistent with the GEP, is outlined and briefly discussed. (Consumer Summary produced by Reliance Medical Information, Inc.)

Quality management

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Skin and eye diseases among arc welders and those exposed to welding operations

Article Abstract:

Study of 77 welders, 75 people exposed to welding, 58 people not exposed to welding showed frequent cutaneous erythema, cutaneous scars. No significant difference found in actinic elastosis, dermatoses, skin tumors, ocular abnormalities.

Welding repair, Physiological aspects, Eye diseases, Welding

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