[Re-use of medical data for research. What do the Dutch think of the requirement for explicit consent?]. / Hergebruik van medische gegevens voor onderzoek. Wat vindt de Nederlander van het toestemmingsvereiste?

OBJECTIVE: How do healthcare consumers perceive the use of medical data for scientific research, within the framework of protection of their personal data? DESIGN: Survey among 731 members of the Healthcare Consumer Panel of the Netherlands Institute for Health Services Research (NIVEL). METHOD: A written and online questionnaire was used, consisting of general questions and 4 cases per respondent. The questions concerned the degree of trust respondents have in the use of previously registered data for different kinds of healthcare research, and their willingness to make data available under various conditions without being asked for explicit consent. RESULTS: Respondents showed a high degree of trust in scientific researchers and physicians concerning the re-use of medical data for research. A majority agreed that it is not necessary to be explicitly asked for consent for this kind of research, providing they are informed: one-third found their autonomy in being able to decide to be more important than scientific progress; three-quarters found explicit permission unnecessary as long as the data is well-protected and only used for scientific research. CONCLUSION: Data protection in research should be proportional to the risks of misuse and the benefits of the use of the data for research. A large majority of healthcare users trust the researchers, and the existing codes of conduct protect data sufficiently. Therefore, we see no need for stricter requirements for the use of health data, which would unnecessarily limit healthcare research. We do consider greater transparency about the research process to be necessary, in order to maintain a proper balance between personal-data protection and the need to emphasise the necessity for learning in the healthcare system.

Comparing the outcome of two different procedures to handle complaints from a patient's perspective.

AIM OF THE STUDY: To assess differences in patient satisfaction between a complaints procedure designed towards the needs of complainants (referred to here as the 'Committee') and a procedure that primarily aims at improving the professional quality of health care (referred to here as the 'Board'). METHOD: Patients' experiences and satisfaction were assessed through a questionnaire completed by 80 patients complaining to a Board and 335 to a complaints Committee. Only complainants with a complaint that was judged to be founded or partially founded were included. RESULTS: Only half of the complainants reported being satisfied with the procedure they underwent. After controlling for differences in respondent characteristics, satisfaction with the Board was higher than with the Committee. The level of variance explained, however, was low (3%). The majority of respondents reported favourably on procedural aspects, for example, the impartiality of the procedure, and empathy demonstrated for their situation. Only a minority of complainants in both procedures believed that changes would be made as a result of their complaint. DISCUSSION: The absence, in the eyes of most complainants, of tangible results of filing a complaint in both rather formal procedures may serve as an explanation for both the low level of overall satisfaction and the fact that the procedure which was developed specifically for patients did not perform better. To resolve the problem of low satisfaction with complaints handling, procedures should be developed that offer a basic degree of procedural safety. But this procedural safety should not stand in the way of what complainants really want: changes for the better.

The potential of legislation on organ donation to increase the supply of donor organs.

OBJECTIVES: The aim of this paper is to assess the possibilities to adapt the 1998 Dutch Organ Donation Act, taking account of fundamental principles such as the right to physical integrity, equitable access to and equal availability of care, and the non-commerciality principle, with a view to increasing the organ supply. METHODS: In 2008 the Dutch Taskforce on Organ Donation presented several proposals to amend the Act and to increase the supply of organs. This paper describes the proposals to amend the Act and evaluates them by assessing their intrinsic adherence to basic principles and the available evidence that these proposals will indeed increase the organ supply. RESULTS: Several proposals could constitute an infringement of fundamental principles of the Act. Moreover, evidence for their impact on the organ supply is lacking. Changing the consent system is possible, as this would not incur legal objections. There are diverging views regarding the impact of consent systems on the organ supply. CONCLUSIONS: The scope for changing the Act and its impact on organ procurement is at best limited. Relying on legislation alone will possibly not bring much relief, whereas additional policy measures may be more successful.

Donor education campaigns since the introduction of the Dutch organ donation act: increased cohesion between campaigns has paid off.

Governments utilize special policy measures to increase and maintain positive attitudes among their citizens towards consent registration and organ donation. Little has been published on these national strategies. Some studies report on the impact of single policy measures shortly after their implementation, whereas the assessment of the impact of a national strategy on organ donation over a long period of time has been lacking. The aim of this study is to assess the impact of the Dutch donor education strategy (1998-2008) on the availability of donor organs, by trying to disentangle the impact of education from other factors. In this study, we have devised a research strategy to assess the impact of policy measures at national level, while providing information about Dutch initiatives to increase registration and procurement rates, and demonstrating and explaining these increases. The increased resources and improved strategies employed to educate the public in relation to organ donation have paid off, but the impact decreases over time. The question remains whether the effects of these policy measures will further level off over time and what levels of increase in donor registration rates and efficiency of donor procurement are realistic targets to achieve.

Imagining the impact of different consent systems on organ donation: the decisions of next of kin.

Next of kin play an important role in organ donation. The aim of this study was to assess the extent to which explicitness of consent to organ donation by the deceased impacts the likelihood that next of kin will agree to organ donation of the deceased by using hypothetical cases. Results indicate that that people say they are more willing to agree to donate organs of those who explicitly consented to donate than those whose permission to donate is presumed. The degree of explicitness for the consent to donate by the deceased appears to influence the next of kin's decision about whether to agree to donation. This variation might explain the absence of differences in efficiency between various types of consent systems.

The impact of donor policies in Europe: a steady increase, but not everywhere.

BACKGROUND: Transplantable organs are scarce everywhere. Therefore, countries have developed policies to support the efficient use of potential donors. Nevertheless, the shortage of organs remains. Were these policies in vain? The aim of this study is to assess the impact of donor policies on donor procurement in 10 Western European countries from 1995 to 2005. METHOD: To assess the impact of the donor policies we studied the conversion of potential donors into effectuated donors. 80% of the donors died from CVAs or a (traffic) accident. We considered these mortality rates to be a good proxy for potential donors. Here we call the conversion of potential donors into actual donors 'the donor efficiency rate by proxy'. RESULTS: The mortality rates for CVA and (traffic) accidents have decreased in the countries under study. At the same time, in most countries the donor efficiency rates have steadily increased. The variance in donor efficiency rates between countries has also increased from 1995 to 2005. Four countries introduced a new consent system or changed their existing system, without (visible) long-term effects. CONCLUSION: The overall increase in donor efficiency means that the efforts to improve donor policies have paid off. However, substantial differences between countries were found. The success of donor policies in terms of the number of absolute donors is blurred by the success of policies on traffic safety and CVA treatment. It remains unclear which specific policy measures are responsible for the increase in donor efficiency rates. This increase is not related to having a presumed consent system. Furthermore, an analysis of countries that introduced a new consent system or changed their system showed no effect on donor efficiency.

Opting-out systems: no guarantee for higher donation rates.

There are considerable differences in the number of organ donations between countries. It is assumed that opting-out systems have a significantly positive impact on the national organ donation rate. The aim of our study was to establish whether different consent systems explain the difference in organ donation rates between countries when taking into account the difference in relevant mortality rates. For this study, we compared data on donation and relevant mortality rates for 10 different countries as well as information on the existing consent systems. This international comparative study shows that there is a strong correlation between mortality rates and donation rates (Spearman's rho = 0.81 (P < 0.01). International comparative legal research has shown that the differences between decision systems are marginal. When the national organ donation rates are corrected for mortality rates, these findings are confirmed: the donor efficiency rate shows that opting-out systems do not automatically guarantee higher donation rates than opting-in systems.