Assessment of appropriateness of screening community-dwelling older people to prevent functional decline.

OBJECTIVES: To identify appropriate screening conditions, stratified according to age and vulnerability, to prevent functional decline in older people. DESIGN: A RAND/University of California at Los Angeles appropriateness method. SETTING: The Netherlands. PARTICIPANTS: A multidisciplinary panel of 11 experts. MEASUREMENTS: The panelists assessed the appropriateness of screening for 29 conditions mentioned in guidelines from four countries, stratified according to age (60-74, 75-84, ≥85) and health status (general, vital, and vulnerable) and received a literature overview for each condition, including the guidelines and up-to-date literature. After an individual rating round, panelists discussed disagreements and performed a second individual rating. The median of the second ratings defined the appropriateness of screening. RESULTS: The panel rated screening to be appropriate in three of the 29 conditions, indicating that screening was expected to prevent functional decline. Screening for insufficient physical activity was considered appropriate for all three age and health groups. Screening for cardiovascular risk factors and smoking was considered appropriate for the general and vital population aged 60 to 74. Of the 261 ratings, 63 (24%) were classified as uncertain, of which 42 (67%) concerned the vulnerable population. The panelists considered conditions inappropriate mainly because of lack of an adequate screening tool or lack of evidence of effective interventions for positive screened persons. CONCLUSION: The expert panel considered screening older people to prevent functional decline appropriate for insufficient physical activity and smoking and cardiovascular risk in specific groups. For other conditions, sufficient evidence does not support screening. Based on their experience, panelists expected benefit from developing tests and interventions, especially for vulnerable older people.

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.

Targeted agenda program: an innovative approach to facilitate progress in disaster health.

The Targeted Agenda Program (TAP) has been introduced for the first time during the 15th World Congress on Disaster and Emergency Medicine (15WCDEM) in Amsterdam in 2007 to stimulate interaction between the participants before, during and after the congress. A TAP process consists of 11 steps, starting with defining a relevant issue and ending with the publication of a TAP report based on expert opinions. Seven TAP groups participated during the 15WCDEM. The TAP issues referred to: (1) the need for health impact assessment of disasters; (2) the golden standard for preparedness for a chemical, biological, radiological and nuclear disasters; (3) the role of acute psychosocial first aid; (4) the 10 most important issues for policymakers to minimize health effects of floods; (5) the search for a golden standard in the treatment of wounded combatants; (6) the preparedness of health organizations for consequences of extreme weather conditions; and (7) the health problems of high-vulnerability groups during disasters. This article describes the motivation and operational aspects of the TAP and advocates that this concept can play an important facilitating role in focus, networking and enhancement of knowledge in the field of disaster health.

Effectiveness of an outreach treatment program for inner city crack abusers: compliance, outcome, and client satisfaction.

In a randomized controlled trial the effectiveness of an outreach treatment program (OTP) was compared with standard addiction care services for hard-drug addicts in Rotterdam (The Netherlands). The study aimed at chronic, high-risk crack abusers who were insufficiently engaged in standard addiction treatment services. Data were collected from February 2000 to December 2001. A total of 124 subjects participated in the study at baseline. Follow-up data were available for 94 subjects. Outcome measures included treatment compliance, outcome, and satisfaction. Data were collected by means of monthly registrations, EuropAsi interviews and an evaluation form. There was a high compliance with OTP in the treatment group; the average length-of-stay was 6 months, with visits three times a week. Although both groups were well represented in standard care, participation was mainly based on methadone maintenance. Subjects treated in OTP showed significant improvements in physical health, general living conditions, and psychiatric status, but no change in employment, substance abuse, and legal status. The control group remained almost unchanged. Clients of OTP reported feeling very satisfied with their treatment. On-the-spot incentives and a positive relationship with the care provider were directly associated with treatment retention. An outreach treatment program, as conducted in this study, is associated with high compliance, general improvement, and treatment satisfaction. Characteristics of this treatment modality are (1) assertive outreach, (2) a mixed program with incentives, and (3) a strong focus on individual-bound therapy. Further research is needed with larger groups and similar conditions at baseline assessment.

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.