Journal of evaluation in clinical practice
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If the relative effectiveness of different treatments that might be used in clinical practice is to be evaluated reliably, it is very important that the evaluation is carried out in an appropriate manner. This is especially true where the differences between treatments are expected to be moderate, and so easily obscured by the play of chance or systematic bias. Although such differences are often of considerable clinical importance, they can be difficult to assess and require a large amount of randomized evidence. ⋯ This approach requires considerable time and effort. However, it will add to the analyses that can be performed and will remove many of the problems associated with a reliance on published data alone and some of the problems that can arise from the use of aggregate data. This paper sets out some of the reasons for this and some of the techniques used for individual patient data-based meta-analysis.
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Valid guidelines, when appropriately disseminated and implemented, can lead to changes in clinical practice and improvements in patient outcome. Guidelines are more likely to be valid if they are developed using systematic reviews, national or regional guideline development groups (including representatives of key disciplines) and explicit links between recommendations and scientific evidence. This paper discusses the practical implications of adopting this approach for guideline development and the role of peer review guidelines as another element of the process to ensure validity. ⋯ Good leadership and technical support are required for the successful development of clinically valid guidelines, which is dependent upon the small-group processes of guideline development panels and the translation of evidence into recommendations. Future guideline developers need to gain expertise in these areas. Research priorities are identified.
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Proliferation of clinical guidelines has given rise to a number of concerns about the status of clinical advisory statements. Are guidelines advisory or mandatory? What regulatory functions do guidelines serve; do they allow clinical discretion a large enough role? Relationships between legislation and guidelines, and the way courts go about determining the legal status of guidelines, are explained. The following questions in the context of the law of negligence are addressed. ⋯ Protocols and guidelines provide the courts with examples of clinical standards across a wide range of medical practice. As guidelines proliferate, so they will increasingly be used in court. However, adherence to guidelines has not automatically been equated with reasonable practice, and the courts seem unlikely to follow the standards enunciated in clinical guidelines without critically evaluating their authority, flexibility and scope of application.
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'Audit' is now in widespread use in our National Health Service, but there is little documentation of improvement resulting from audit. If it is to be used to identify mistakes in clinical practice, we must be prepared to admit them, or to have our work evaluated by others; such openness is uncommon. Understandably, doctors are concerned about possible litigation, undermining of their authority, and/or interference with their methods of practice. ⋯ Its educational value is self-evident. It allows the identification of deficiencies, and the provision of feedback to correct them. Furthermore, it provides for a continuum of audit through the undergraduate and postgraduate years of a doctor's training.