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• W1486806516 abstract "Patients in control groups assigned to receive standard treatment in therapeutic clinical trials tend to fare better than otherwise similar patients treated with best practice alone, irrespective of any effect in the active comparator group [1]. One reason may be that such patients benefit from the discipline imposed by a formal protocol with specified follow-up, monitoring and so on, although additional factors no doubt contribute as well. This is one reason why we support enrolment of patients into such trials, when a suitable study is available [2]. When no suitable clinical trial is available, formal checklists [3] and treatment guidelines offer some of the discipline of a trial protocol. Do they deserve three cheers? That depends on the quality of the guideline, individual aspects of the patient and their disease and the thoughtfulness and medical decision making/therapeutic skills of the clinician.Guidelines should provide guidance and act as ‘aides memoire’ and can rather seldom usefully stipulate rigid algorithms – clinical medicine is often too complicated to be reduced to a kind of ‘painting-by-numbers’ recipe cookbook. To be useful they need to be used and to be used they must be succinct. Individual factors unique to each patient including comorbidities, concurrent medications, cultural preferences and personal circumstances to name but a few must be weighed and factored in and this demands knowledge and skill on the part of the clinician. Where such is the case, guidelines surely deserve three cheers, but where they are verbose or overly proscriptive, rather less.Much research has gone into the difficulties of persuading doctors to adhere to treatment guidelines and there is empirical evidence demonstrating that treatment recommendations are often not implemented [4]. Confusion sometimes reigns when guidelines are inconsistent. The glut of guidelines from a multitude of authoritative local, national and international bodies is probably one important reason for the limited impact of such didactic advice. Take for example the hypothetical journey of a patient with fractured neck of femur requiring emergency anaesthesia and orthopaedic surgery, where it has been estimated that health care professionals will have to navigate 75 different clinical guidelines from hospital admission to discharge [5]. The volume of material, diversity of recommendations and complexity of guidance is likely to create a state of bewilderment in prescribers and confused, inconsistent management of patients. In this era of personalized electronic communication, text messaging can contribute to a possible solution. An innovative randomized controlled trial of text messaging in Africa showed significant improvements in the appropriate use of artemether-lumefantrine (as advocated by national guidelines) for patients with malaria [6]. More prosaically, but perhaps no less important for those of us who wish to retain some self-respect as clinical pharmacologists, this issue of the Journal contains a study where recommendations made by clinical pharmacologists on an electronic prescribing system were more likely to be accepted by physicians, than the good ol' fashioned practice of scrawling in the notes or drug chart [7].Rather than relying on new-fangled technology (which may be expensive and prone to breakdown) some simpler tactics directly exploit the human tendency to follow the path of least resistance. Kahan and colleagues demonstrated that within a health insurance network, the simple act of removing the need for prior authorization for losartan prescriptions had the desired effect of achieving a marked drop in prescriptions for valsartan and a switch towards the less expensive preparations of losartan [8]: modifying the behaviour of physicians may be less to do with erudite guidance and exhortations, but more to do with providing the relevant (dis)incentives via a route of least ‘hassle’.While getting physicians to adopt treatment guidelines is difficult, there are equal or even greater challenges in persuading doctors to lodge spontaneous reports of suspected adverse drugs reactions, an area that has been plagued by inconsistent and poor reporting. What are the key drivers that lead physicians and other health care professionals to report or, more commonly, not report adverse drug reactions? This is an important methodological question when considering the special section in this month's issue of the Journal featuring a study of disproportionality analysis in assessing spontaneous reports [9]. Here, in two related commentaries we draw attention to the debate surrounding the increasing use of disproportionality analysis, and emphasize for our readers, the pros and cons of such methods [10, 11]. The evaluation of relative or absolute risks from the numerous spontaneous reporting databanks has so far been hindered by the lack of information on number of people exposed to the drug, thus making it almost impossible to determine accurately if the excess of reports of a specific adverse event with a particular drug (relative to other similar drugs) was due to greater numbers of patients taking the drug or a genuine reflection of a higher potential incidence for harm.In its simplest form, disproportionality analysis could tackle this Achilles heel by looking at the frequency of reports for the specific adverse event as a proportion of total number of other adverse events for that drug. This would be a relatively straightforward task to perform, involving counting up numbers of certain adverse events for the drugs of interest and estimating odds of particular adverse events being reported in that database. However, the key methodological issue here rests firmly on the question whether the tendency for a spontaneous report to be submitted is a genuine reflection of the actual frequency of the adverse event in the population. All manners of detection and reporting bias might occur, for instance, greater awareness of safety problems with rosiglitazone might hypothetically result in a greater number of adverse event reports, and a consequent dilution in the proportion of bladder cancer reports. Indeed, a recent research paper found a marked increase in spontaneous reporting of adverse events with statins (particulary myalgia and arthralgia) following a Dutch television programme on the benefits and risks of statins [12, 13]. In our view, the multitude of factors that exert an influence on the decision of patients or healthcare professionals to report (or not report) certain adverse events create major challenges in the interpretation of disproportionality analysis. Caveat emptor!" @default.
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• W1486806516 date "2011-11-09" @default.
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• W1486806516 title "Two cheers or three for treatment guidelines? Nudging prescribers in right directions" @default.
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