Quality of Studies

No single criterion can be used to judge an epidemiology study. Instead, many 

Guidelines for Carcinogen Risk Assessment note the following considerations of well-paformed studies  

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Once the FDA receive the initial submission, an IND reference number is assigned. The application is then passed on to the appropriate review centre either the Center for Drug Evaluation and Research (CDER), or the Center for Biologies Evaluation and Research (CBER). Various experts will then review the submitted documents, the purpose being to ensure that the safety of subjects is not compromised and, in the case of Phase II and III studies, that the quality of study design is scientifically adequate. The FDA are allowed 30 days to complete the initial review, after which the study can commence, provided that it has been approved by an Institutional Review Board (IRB). 

Consequently, there is no golden standard of calculating indirect Costs-of-Illness. The estimates based on different methodologies might differ significantly, and so will the total Costs-of-Illness of HIV/AIDS. It is possible to analyze the quality of studies whether all components (such as indirect costs of caring relatives etc.) have been included. Whether the methodology applied is best cannot always be determined. 

In recent years there has been a dramatic increase in the number of studies published in the scientific literature that purport to be economic analyses. As with all areas of research, the quality of studies varies and care should be taken when reviewing published (and unpublished) economic analyses. Studies have shown that although improving over time, the general quality of many published economic analyses is still... 

As a detailed interpretation and supplementation of the NRC (1993a) guidelines, the NAC/AEGL Committee has developed guidelines for evaluating the quality of studies to be used in the calculation of proposed AEGL values. The proposed evaluation and documentation procedure created by the NAC/ AEGL Committee is intended to provide technical-support-document writers, reviewers, committee members, interested parties, and the public with... 

The conclusions drawn from our review and evaluation of literature assessing the economic value of clinical pharmacy services published from 1988-1995 are multifocal. The total number of articles published on this topic has grown, as demonstrated by the number in this review (104, average 13/yr) versus the original prospectus (58, average 4/yr), which included articles published from 1974-1987. Although the number of published articles on this topic appears sufficient, an opportunity does exist for improvement in the quality of study design. 

It has been stated already that the primary purpose of GLP is not to guarantee primarily the scientific or technical quality of studies, but to provide transparency in enabling third parties to follow in retrospect the whole course of a study to trace back all activities to procedural standards, to relate activities to the personnel that had performed them and decisions to the authorised individuals, in fact to reconstruct the whole study. While such a purpose of the quality system is valuable in situations where the outcome of a study may not be readily reproducible, and where repeating studies may be out of the question, other situations may require different approaches. 

Similar to evaluating the quality of a clinical trial, sponsorship of a pharmacoeconomic study should be considered when evaluating the quality and usefulness of that study. The quality of studies conducted or funded by different companies or organizations will vary by sponsor, company, product, or evaluation, and the potential for bias should be neither ignored nor assumed. For example, many of the studies sponsored or conducted by the pharmaceutical industry to date have been academically rigorous as well as informative. A clear understanding of how to evaluate, critique, and use the pharmacoeconomic literature appropriately will minimize any potential effects of this criterion on clinical decision making. 

However, the non-specialists who are using and might modify an arbitrary partial model for studies shall be enabled to store and share the results of these studies as well as to record their decisions and rationales. To ensure the quality of studies results, each discipline will have to define a range of admitted models as well as attributes modifications, which a data consumer is allowed to perform. 

Evidence ranking level for etiology depends on the design and quality of studies. The highest level is ranked la and decreases downward. Table modified from the Oxford Centre for Evidence-based Medicine Levels of Evidence website (www.cebm.net/index.aspx o=1025), produced since November 1998 by Bob Phillips, Chris Ball, Dave Sacked, Doug Badenoch, Sharon Straus, Brian Haynes, Martin Dawes. Updated by Jeremy Howick in March 2009. 

There is a need to increase the quantity and quality of studies dealing with the effects of exposure to cold thermal environment on physical working performance. Although cold thermal environment is known to influence performance in all working activities, its... 

Absence of cooperation can sometimes compromise the quality of study. Medications are usually not used for US scanning, but light sedation (equi-molecular mixture of nitrous oxide and oxygen, midazolam, hydroxyzine) could be considered in some circumstances, such as Doppler recordings. For further information on sedation, refer to VCU and CT sections in the same chapter. 

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