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The prestigious journal Biostatistics published in July 2017 six solicited commentaries on the role of the U.S. Food and Drug Administration (FDA), as times change, with ever developing technical tools for clinical trials and their evaluation, with increased focus on personalised medicine (possibly aided by genetic testing), and on patient self-determination. Two were written by American economists, four by leading biostatisticians, mostly from the USA. This paper summarises these texts for a Danish audience.

This paper is a review of the literature on health professionals with substance abuse and it deals with the epidemiology, treatment, and results. A similar study has been carried out on health professionals in Denmark. Very few data are available for this group. The prevalence of substance abuse in health personnel seems to be equal to that in the general population, and from these data it is estimated that 3300 doctors/nurses in Denmark have an active alcohol abuse whereas the prevalence of other drug abuse is not known. The National Board of Health receives 150 new cases a year, in which decisions about specific treatment are made. Not all these cases are about substance abuse. Today, no organised treatment is on offer to health personnel with substance abuse, and they are forced to find their own. Results from abroad indicate that treatment with some degree of monitoring gives better results for health personnel than no monitoring, perhaps because of the risk of losing their authorisation, which is the penalty in this group, if substance abuse continues. From the results of a Danish study, the treatment in Greater Copenhagen seems less effective than the treatment given abroad. It is, therefore, recommended that the treatment of health personnel should be centralised in three or four places in Denmark, each with capacity for 30 outpatients. It is furthermore recommended that inpatient treatment of health personnel in work, which, generally speaking will be that needed in connection with detoxification, takes place in departments with a special interest in treating this kind of patient. Inpatient treatment is furthermore recommended for patients with psychiatric or somatic co-morbidity in addition to the substance abuse, or where repeated attempts at outpatient treatment have been unsuccessful. The estimated need is the possibility of admittance to two psychiatric beds per centre. Lastly, it is recommended that structured treatment in this group of patients should be established in close co-operation with the unions for advisory or legal assistance in the case of early retirement or change of job.

Internationally, there is solid experience on accreditation. Accreditation in the present paper is described in the form that is used in the three biggest and oldest organisations, The Joint Commission on Accreditation of Healthcare Organization (JCAHO), The Canadian Council on Health Services Accreditation (CCHSA), and The Australian Council on Healthcare (ACHS). Common elements in the organisations are standards, indicators, surveyors, surveys, accreditation report, and end result. The development in the three organisations has been different. However, the establishment of The International Society for Quality in Health Care (ISQua) and The Agenda for Leadership in Programs in Healthcare Accreditation (ALPHA) programme has motivated increasing comparability. The fact that association between accreditation and quality in patient care has not been demonstrated is a weak point. However, standards in the accreditation organisations require the use of clinical guidelines in order to increase the quality of patient care. From the "Health Policy Report 2002" it appears that external assessment in the form of accreditation is going to be a reality in the Danish healthcare sector. Hospitals of all counties and within The Copenhagen Hospital Corporation must undergo accreditation before the year 2006.

The purpose of the paper is to study methods for costing hospital services specifically in relation to multi-unit studies of activity, case-mix, severity-of-illness, outcome, and resource use in adult intensive care units. The article reviews 20 published cost studies of adult intensive care units. The studies are all published in English and are both European and American. Cost of intensive care therapy is compared across the 20 studies. However, as stressed in the article, to compare costs of intensive care therapy across units is not possible for a number of reasons. One of the reasons is the fact that the studies employ different approaches to costing and thereby introduce a methodological bias. In addition, the costing methodology applied in the majority of the studies has been wrongly specified in relation to the purpose and the viewpoint of the studies. The article concludes that the methodologies for costing intensive care unit therapy are flawed and fail to provide correct answers. In addition, the study question is in most studies not adequately specified and the cost concept used in the studies is not tailored to the purposes of the studies.