Treatment guidelines are continuously becoming an important part of medical reality especially since the carrying of research findings to everyday clinical practice is becoming increasingly difficult. They aim to assist clinicians but also policy makers to arrive at decisions concerning the treatment and care of patients. They set the standard of care and training for health professionals and eventually they identify priority areas for further research since they are based primarily on the available evidence, but also, in areas where evidence is not available, on expert opinion.

Especially in psychiatry, the accumulated knowledge is often complex, confusing and in many instances in contrast to the beliefs and practices which are solidly embedded in psychiatric culture and training for the last few decades.

There is a number of issues that characterize the development of treatment guidelines. One of the most recent and controversial is the representation of different stakeholders in the workgroup, that is also patients and the pharmaceutical industry are represented. Although it is supposed that experienced scientists should constitute the core of the team, it is not unusual that persons with little clinical or research background take the lead, and often the overwhelming majority are not psychiatrists. Conflicts of interest are not always reported adequately and this constitutes a serious ethical problem. According to most recent concepts, the conflict of interest does not include merely any direct or indirect economic transaction related to the topic (including honoraria and even support by the industry to participate in congresses) but also academic-related issues like career characteristics and affiliations (e.g. chair of association related with a specific treatment option, or focus on research on a specific treatment field). Recently the American Psychiatric Association faced a dead end with the publication of the treatment guidelines for bipolar disorder because of its strict policy concerning the conflict of interest. APA adopted a new guideline development process to meet standards of the Institute of Medicine published in March 2011 and since then most of its guidelines have not been updated.

The method for the grading of data is of prime importance in the development of guidelines because it is the tool which leads to the hierarchical preference concerning treatment options. Such methods exist since the early 1980s. All of them include a method to assess the quality of data and a method to arrive at recommendations on the basis of the extent to which we can be confident that the desirable effects of an intervention outweigh the undesirable effects. The values and preferences factor as well as the cost are also taken into consideration by various workgroups. Starting in 1992 five steps were developed to summarize the process of individual-level decision making and they were published in 2005.¹ They include: (a) the formulation of a precise and answerable question and avoiding uncertainty and vague statements, (b) the performing of a systematic search and retrieval of the evidence available, (c) the critical review and classification of the retrieved evidence with the recognition of the presence of systematic errors, various types of bias, confounders, reliability and validity issues etc. The clinical significance and the generalizability of the results should be taken into account also, (d) application of results in practice and (e) evaluation of performance.²

It is important to assess the quality of the evidence which come from the sources described above. The quality assessment is based on the strength of their freedom from the various biases that beset medical research. In this frame, triple-blind, placebo controlled trials with allocation concealment and complete follow-up involving a homogeneous patient population and medical condition should be considered to constitute the highest grade, while case reports should be considered to constitute the lowest grade. Expert opinion should not be considered to be a source of evidence although it could be a valuable tool for the development of guidelines.

Until recently there are a number of grading systems for assessing the quality of evidence which were developed by different organizations. One of them is the U.S. Preventive Services Task Force (USPSTF) and another system is the Oxford (UK) CEBM Levels of Evidence, which also is useful for the grading of diagnostic tests, prognostic markers, or harm and constituted the basis for the use of the BCLC staging system for diagnosing and monitoring hepatocellular carcinoma in Canada. Another method to grade data is the PORT method which has been used by the World Federation of Societies of Biological Psychiatry for the development of the WFSBP guidelines.^3–5

The most detailed and precise modern method seems to be the GRADE method (short for Grading of Recommendations Assessment, Development and Evaluation) for the development of guidelines⁶ which clearly separates quality of evidence from level of recommendation and suggests it is necessary to include a clear question which should include all four components of clinical management (patients, an intervention, a comparison, and the outcomes of interest) and to grade the outcomes into those who are critical for the decision making and into those who are not. In this frame, the assessment of the quality of evidence is important since it reflects the confidence whether the effect is adequate to support recommendations. The determinants of quality are study limitations, inconsistency of results, indirectness of evidence, imprecision and reporting bias.^7–12

Today the development of guidelines seems to be an absolutely necessary element not only of clinical practice but also for scientific research itself, since it is the final tool to assess the advances and the unmet needs and to propose future actions.

Konstantinos N. Fountoulakis
Associate Professor of Psychiatry,
3rd Department of Psychiatry ,
Aristotle University of Thessaloniki

References

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