The quality of medical care at the end of life has become of major importance in contemporary developed societies [1
]. In the past century there has been a significant shift in cause of death, away from acute deaths due to infectious disease towards deaths caused by chronic and degenerative illness such as cancer and cardiovascular disease [1
]. Combined with rising life expectancy and an ageing population, this epidemiological transition has resulted in an increased number of people experiencing a terminal illness phase at the end of life [1
Parallel to these changes in the patterns of dying, advances in medical knowledge and technology have contributed considerably to the increase of treatment possibilities at the end of life. Physicians are now increasingly able to ensure effective treatment of pain and symptoms at the end of life, and to postpone a patient's death [1
]. However, in many cases a point is reached where those involved feel that prolonging life is no longer desirable as a certain minimal quality of life cannot always be maintained [1
]. This gives rise to decisions that possibly or certainly hasten the patient's death, i.e. end-of-life decisions (ELDs). These decisions include withholding or withdrawing potentially life-sustaining treatment, intensifying pain and/or symptom management with a possible life-shortening effect and administering drugs with the explicit intention of hastening death (i.e. physician-assisted suicide, life-ending without the patient's explicit request, and euthanasia).
Past studies in different countries have revealed that these various end-of-life decisions are made in a significant proportion of deaths [8
], although incidence estimates vary somewhat across countries. According to the 2001 EURELD study in six European countries (Belgium, The Netherlands, Denmark, Italy, Sweden and Switzerland) the incidence of deaths preceded by an ELD ranges from 23% to 51% [14
]. In Belgium the incidence rate dropped slightly, although not statistically significantly, from 39,3% to 38,4% between 1998 and 2001 [19
]. These studies contributed to an ongoing ethical and legal debate concerning end-of-life decisions, culminating in Belgium in 2002 with the passing of the laws on palliative care, patients' rights and euthanasia (which permits euthanasia under strict conditions of prudent practice) [21
It is in this new legal context that a third ELD study in Belgium was undertaken. This study is part of the larger M
onitoring quality of E
are (MELC) study in Flanders [25
], and aims to obtain reliable incidence estimates of ELDs and their characteristics in Flanders for 2007, as well as to take a closer look at the decision-making process preceding ELDs and the treatment and care provided at the end of life. As a third measurement point for Flanders, one of the research aims is to permit a trend analysis of end-of-life decision making. Furthermore, the legalisation of euthanasia since the last ELD study in Flanders creates the opportunity of estimating the possible effects of the euthanasia law on the practice of euthanasia and other end-of-life practices [24
], and will shed light on the argument that legalising euthanasia will possibly lead to a slippery slope, e.g. a rise in life-ending acts without the patient's explicit request [26
]. Comparison of the results of the Flemish study to the Dutch data from 2005 will put the findings in an international perspective [24
To design an adequate methodology for a nationwide study of ELDs is not straightforward because of the sensitive nature of the issue and the specific difficulties involved in the organisation of such a survey. In this article we present the protocol of the 2007 Flemish ELD study, which was guided by four methodological questions: (1) which study design is most appropriate for obtaining reliable incidence estimates and descriptions of ELDs, even of rare ELDs, that are representative for all deaths in Flanders in 2007?; (2) how can comparability with earlier ELD studies in Flanders and other countries be ensured?; (3) how can strict anonymity of physicians and patients for ethical and judicial reasons be guaranteed?; and (4) how can a sufficient response rate for a survey on this sensitive subject be achieved?
The study design we present in this article is based on a method, first developed in the Netherlands in 1990 [9
], that has been successfully used in several European countries to study the nationwide incidence and characteristics of ELDs [8
]. However, this is the first time that this study design has been described in detail. We believe that presenting it will be useful to researchers in other countries who intend to embark on similar research. The methodology outlined in this article will also serve as a reference for future publications using data from this study.