A discrete choice experiment to identify the most efficient quality indicators for the supervision of psychiatric hospitals.

BACKGROUND: In the Netherlands, health care is regulated by the Health and Youth Care Inspectorate. Forty-six indicators are used to prioritize supervision of psychiatric hospitals. The objective of this study is to define a smaller set of weighted indicators which reflects a consensus among inspectors about which aspects are most important for risk assessment. METHODS: The set of 46 indicators, complemented with missing information, was reduced to six indicators by means of interviews, group discussions and ranking among the inspectors. These indicators were used as attributes in a discrete choice experiment (DCE) to define their weights. RESULTS: Twenty-six inspectors defined the top four indicators suitable for the risk assessment of psychiatric hospitals. These are: the policy on prevention of compulsory treatment; the policy on dysfunctional professionals; the quality of internal research after a serious incident; and the implementation of multidisciplinary guidelines on suicidal behaviour. These indicators share the same importance with regard to risk assessment. The screening of somatic symptoms and the policy on integrated care are important indicators too, but less relevant. CONCLUSION: Through a DCE, we reduced the amount of information for risk assessment of psychiatric hospitals to six weighted indicators. Inspectors can use these indicators to prioritize their inspections.

The development of quality indicators in mental healthcare: a discrete choice experiment.

BACKGROUND: Health care regulatory agencies perform audits or inspections to judge the quality and safety of health care. This judgment is based on the assessment of a large set of health care indicators as accepted by the profession. However, there is a lack of knowledge about the influence of these indicators and whether a smaller number would be sufficient for a quality assessment or audit procedure. METHODS: A discrete choice experiment (DCE) was performed for the assessment of quality of care regarding the management of patients with schizophrenia and drug dependency in psychiatric institutes. Based on multidisciplinary guidelines for the treatment of schizophrenia and a visit of (co)inspectors of the Dutch Healthcare Inspectorate at all 33 integrated mental hospitals a set of 51 indicators were assessed in a subsequent interview. With the analysis of the results, 6 attributes were selected for the DCE as quality indicators. RESULTS: Seventy-six percent of all health services (co)inspectors (n = 33) involved in the inspection of mental health services, participated in the experiment. Respondents considered an operational elaborate treatment plan the most important indicator for the assessment of quality of care in a psychiatric institute, followed by a general care program, treatment outcome measurement, and involvement in treatment of patients and relatives. Pharmacotherapy and governance responsibility were valued as less important indicators. CONCLUSIONS: The results of this DCE show that there is a prioritisation in the six selected quality indicators. This might help health services (co) inspectors to enhance the efficiency and transparency of the quality of care assessment for patients with schizophrenia and/or drug dependency in psychiatric institutes.

Randomized consent designs in randomized controlled trials: systematic literature search.

BACKGROUND: Three types of randomized consent designs are distinguished and ranked according to the extent to which participants are informed about treatment options: single-consent (those in the experimental group learn about their assigned treatment), incomplete-double-consent (all participants learn about their assigned treatment), and complete-double-consent (all participants learn about all treatments studied). All are methodologically, ethically, and judicially controversial. Even so, their use is justified if blinding is deemed necessary, but impossible to achieve by sham procedures (placebo), and experimental treatment seems attractive to potential participants. OBJECTIVE: The aim of this study is to give a comprehensive overview of the use of randomized consent designs. Data sources are MEDLINE (1/1977-2/2003), EMBASE (1/1984-2/2003), PsycINFO (1/1996-2/2003), the Cochrane Library, and the Science Citation Index database. REVIEW METHODS: Eligible were studies using a randomized consent design. Cluster randomized trials were excluded. One reviewer selected and data-extracted eligible papers. A second reviewer independently data-extracted 10% of the papers. Data on country of study conduct, year of commencement, area of medicine, type of design, reason(s) for use, details on approval by a research ethics committee, the index and reference intervention, nature of endpoints, and details on collection of data were extracted. Furthermore, for each trial, the rates of non-compliance and loss to follow-up were registered by treatment arm. The three types of randomized consent designs were compared as to differences between the rates of non-compliance and loss to follow-up in the separate trial arms. RESULTS: Randomized consent designs are seldom used (n=50). When used, they have often been used in the wrong circumstances (misuse). In 65% of the studies the non-compliance in the index group is larger than in the reference group. Contrary to expectation, trials using the incomplete-double design were associated with significantly higher rates of non-compliance and loss to follow-up in the reference groups than trials employing the other two versions. CONCLUSION: Trialists and physicians should be aware of the proper indication for the use of randomized consent designs.

Members of research ethics committees accepted a modification of the randomized consent design.

BACKGROUND AND OBJECTIVE: The use of randomized consent designs has been subject of methodologic and ethical controversy. In most Western countries, research ethics committees make the decision as to whether a randomized consent design can be applied. The purpose of the study is to assess to what extent a randomized consent design and a modification of this design is accepted by research ethics committees, in terms of ethics, health law, and methodology. METHODS: A postal survey was conducted among members of research ethics committees in the United Kingdom, and in The Netherlands, with professional competence in ethics, (health) law, methodology, or clinical practice. RESULTS: In both the UK and in The Netherlands, the modified randomized consent design appears to be statistically significantly more acceptable than the randomized consent design, with respect to ethical and judicial aspects. The overall rejection rate of the randomized consent design was 66% in the UK and 59% in The Netherlands. However, the modified randomized consent design was rejected by 47 and 41% in the two countries, respectively. CONCLUSION: the modified randomized consent design appears to be more acceptable than the randomized consent design. To increase consistency in the way research ethics committees handle study protocols, a discussion about the use of randomized consent designs appears necessary.

Indications and requirements for the use of prerandomization.

BACKGROUND AND OBJECTIVE: Although in effectiveness studies, the conventional randomized trial, in which informed consent is obtained before randomization, is the first choice, this design is not the panacea for all research questions. To counter contamination problems, prerandomization designs might be an alternative. Prerandomization implies that the randomization takes place before seeking informed consent, and because of this, prerandomization designs are controversial among ethicists, health lawyers, methodologists, and clinicians. However, in the Netherlands, these designs are becoming more accepted since the Dutch State Secretary of Health, Welfare and Sport decided that, under certain circumstances, prerandomization is admissible and not in conflict with the law. RESULTS: Based on well-defined indications and requirements, guidelines for the optimal application of prerandomization designs are presented. Designs in which prerandomization is used are outlined; methodological considerations useful when conducting trials using conventional designs or prerandomization designs are discussed, in addition to ethical and judicial aspects. CONCLUSION: In certain situations, prerandomization designs have an essential contribution to achieve evidence-based medicine. Banning prerandomization a priori implies that information about the effectiveness of numerous public health and medical interventions will not be forthcoming. Therefore, every design should be based on a balance between maximizing the potential for patient autonomy and minimizing the bias caused by contamination. This balance cannot be reached by formulating general rules, but an independent group of experts, like members of research ethics committee (REC), should decide whether this balance is acceptable.