This Week in PLOS Medicine: Iraqi Civilian Death Toll, Diagnostic Tests Poorly Described, Psychiatric Drug Approval
This week PLOS Medicine publishes the following new articles:
Based on a survey of 2000 randomly selected households throughout Iraq, Amy Hagopian and colleagues estimate that close to half a million excess deaths are attributable to the recent Iraq war and occupation. Estimates that extrapolate from a small number of reported deaths to the entire population are associated with considerable uncertainty, and based on statistical methods attempting to account for this, the researchers say that they are 95% confident that the true number of excess deaths lies between 48,000 and 751,000. The risk of death at the peak of the conflict in 2006 almost tripled for men and rose by 70% for women. Violent deaths were attributed primarily to coalition forces (35%) and militia (32%). The majority (63%) of violent deaths were from gunshots, while car bombs accounted for 12%. While war-related deaths peaked in 2006, as discussed in an accompanying Perspective article by Salman Rawaf, post-war Iraq has limited capacity to re-establish and maintain its battered public health and safety infrastructure. Rawaf argues that living in Iraq today is no longer about how many died but how future deaths should be prevented as the country copes with ongoing conflict.
Evaluation of diagnostic studies is often a challenge in diseases that are not defined by a specific test. Assessment of the accuracy of diagnostic tests is essential because they may be used to define who is considered to have a disease and receive treatment for it. However, measuring the accuracy of a diagnostic test requires an accurate gold standard, which defines which patients truly have and do not have the disease. Studies of diseases not defined by a specific test often rely on expert panels to establish the gold standard. In a systematic review and analysis of the diagnostic literature using expert panels to define the gold standard for a given disease, Loes Bertens and colleagues determined how expert panels were used in such studies and how well their process was described and reliability assessed. In 81 diagnostic studies for psychiatric disorders, half of which pertained to dementia, cardiovascular diseases, and respiratory disorders, reporting was often found to be incomplete, affecting the reader’s ability to judge potential bias in a study and to apply the same study methods.
Corrado Barbui and Irene Bighelli use the example of drugs for psychiatric disorders to highlight the main limitations of current rules governing the approval of new medicines in Europe. The example of psychiatric drugs is relevant because several active treatments are already available on the market, rates of spontaneous remission are very high, placebo and active treatment response is unpredictably erratic and variable, and outcome measures are not clear-cut concepts. The authors address the challenges posed by the requirement for establishing that a drug is effective vs. placebo in conditions with a high and variable rate of placebo effect, recommend potential new ways to address efficacy, and conclude that the European example may be relevant to inform regulatory policies in other systems of care.