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However, the reality was that although NICE was principally aimed at aligning professional standards through clinical guidelines and audit, the acceptability of drugs, devices and technological interventions in defining those standards, could not be ignored and so the concept of a "fourth hurdle" for drugs accessing the NHS market was invoked.
The clinical audit process seeks to identify areas for service improvement, develop & carry out action plans to rectify or improve service provision and then to re-audit to ensure that these changes have an effect. Clinical audit can be described as a cycle or a spiral, see figure.
Their purpose is to engage clinicians in systematic evaluation of their clinical practice against standards (often set by NICE), and to encourage improvement in the quality of care. This programme is gradually being extended to other areas of healthcare, working with clinical, patient and professional advisory groups.
Clinical audit is the review of clinical performance, the refining of clinical practice as a result and the measurement of performance against agreed standards – a cyclical process of improving the quality of clinical care. In one form or another, audit has been part of good clinical practice for generations. Whilst audit has been a ...
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
Plates vi & vii of the Edwin Smith Papyrus (around the 17th century BC), among the earliest medical guidelines. A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare.
Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials , clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes.
The DLQI can provide clinicians with more accurate insight into the impairment of quality of life experienced by individual patients. This may lead to more appropriate clinical decisions. [13] The DLQI can also be used when required by national guidelines, for example in the management of psoriasis [14] or hand eczema. [15]