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PubMed2002

Use of perflubron emulsion to decrease allogeneic blood transfusion in high-blood-loss non-cardiac surgery: results of a European phase 3 study.

BACKGROUND: This single-blind randomized study in general surgery evaluated the efficacy of perflubron emulsion (PFC) as an artificial oxygen carrier being used to augment preoperative acute normovolemic hemodilution to reduce and avoid transfusion of both allogeneic erythrocytes and erythrocytes from preoperative autologous donation compared with standard of care. METHODS: Subjects (N = 492) with hemoglobin concentrations of 12-15 g/dl undergoing noncardiac surgical procedures with 20 ml/kg or greater expected blood loss were randomized into two groups. Control patients were transfused intraoperatively at a hemoglobin concentration less than 8.0 +/- 0.5 g/dl or at protocol-defined, physiologic triggers. PFC-treated patients first underwent acute normovolemic hemodilution to hemoglobin of 8.0 +/- 0.5 g/dl, followed by dosing with perflubron emulsion (1.8 g/kg). When hemoglobin reached less than 6.5 +/- 0.5 g/dl, an additional 0.9-g/kg dose was given. PFC patients were transfused at hemoglobin less than 5.5 +/- 0.5 g/dl or at predefined physiologic triggers. After surgery, hemoglobin was maintained at 8.5 +/- 0.5 g/dl or greater in all patients until discharge. Efficacy endpoints included the number of allogeneic and preoperative autologous donation units transfused and the percentage of subjects avoiding transfusion. RESULTS: Both groups had similar hemoglobin concentrations at screening (13.5 +/- 1.0 g/dl) and at discharge: 10.8 +/- 1.2 g/dl (PFC) and 11.1 +/- 1.3 g/dl (control). At 24 h, more patients in the PFC group avoided allogeneic and preoperative autologous donation erythrocyte transfusions (53% vs. 43%, < 0.05), and fewer erythrocytes were transfused (1.5 +/- 4.8 vs. 2.1 +/- 3.9 units; median, 0 vs. 1 unit; P = 0.013). By day of discharge, these differences were not significant in the intent-to-treat population, but overall there were less allogeneic and preoperative autologous donation erythrocyte transfusions in the PFC group (696 vs. 846 units). In the protocol-defined target population (n = 330 subjects with blood loss > or = 20 ml/kg), significantly greater avoidance of any erythrocyte transfusion was maintained through day of hospital discharge (26% vs. 16% in the PFC and control groups, respectively; P < 0.05), and there was also a significant reduction in the number of erythrocyte units transfused (3.4 +/- 2.9 vs. 4.9 +/- 2.4 units; median 2 vs. 4 units; P < 0.001). Adverse events rates were similar in the PFC (86%) and control (81%) groups; however, more serious adverse events were reported in the PFC group (32%) than in controls (21%; P < 0.05). Overall mortality was 3%, and the difference between groups (PFC, 4% vs. controls, 2%) was not statistically significant. CONCLUSIONS: Augmented acute normovolemic hemodilution with PFC reduces transfusion needs in patients undergoing noncardiac surgical procedures with blood loss 20 ml/kg or greater.

Adult↗
PubMedDate not supplied

Applying an evaluation framework for health information system design, development, and implementation.

BACKGROUND: Dramatic advances in health information technologies necessitate a comprehensive evaluation framework covering all phases of development, from conception to routine operational use. OBJECTIVES: The purpose of this article was to illustrate the application of an informatics evaluation framework that provides a heuristic for matching the stage of system design and the level of evaluation. METHODS: An evaluation framework is illustrated in the context of five studies in different stages of system design. RESULTS: The studies discussed in this article represent the various stages of the framework. In addition, they are examples of how evaluation research studies not only contribute to the assessment of system design but also constitute distinct contributions to knowledge. DISCUSSION: The ability to engineer advanced information systems has exceeded the understanding of how to deploy them effectively in complex settings and to adapt them to a range of user populations. A systematic, continuous evaluation increases the likelihood that the conditions for success will be understood, including how to tailor a system, how to maintain the target population's use of the system, and how to innovate continually to enhance the functionality of the system and the users' experience. Without sound evaluation methodologies throughout the stages of system development, information systems have limited potential to influence healthcare processes positively.

Humans↗
PubMed2002

The role of the African-American physician in reducing traffic-related injury and death among African Americans: consensus report of the National Medical Association.

ISSUE: Traffic-related injuries and fatalities disproportionately affect the African American community. These high rates of traffic-related death and injury among African Americans manifest in multiple areas of traffic safety, including: Failure to use seat belts and child restraints. High incidence of alcohol-impaired driving. Failure to follow child passenger and seat belt safety laws and recommendations. High rates of pedestrian accidents, ofen brought on by impairments of drivers and/or pedestrians. Research indicates that national public information campaigns, with general messages only slightly modified for African American audiences, have not been culturally appropriate or effective in changing traffic safety behavior. In addition, traditional distribution mechanisms for these messages have not effectively reached the target population. Evidence suggests that in the African American community, there is a pervasive lack of knowledge of the devastating impact of traffic-related accidents on the overall health status of the community. This lack of information has resulted in a tragic cycle, in which parents fail to model safe operation of motor vehicles, and generation after generation copy this behavior, increasing the community's vulnerability to serious injuries and untimely deaths. This trend toward improper traffic safety habits among African Americans persists despite federal, state and local laws to enforce and promote sound traffic safety practices. OBJECTIVE: To study the existence of disparities in traffic-related injury and death among African Americans and to determine what kinds of traffic safety messages and campaigns will be effective in encouraging African Americans to respond to safety laws in sufficient numbers to reduce the disproportionately high rate of injury and death. Traffic safety issues were examined to effectively recommend policy, address barriers, best practices, and intervention strategies for the National Medical Association, its physician members, their patients, and their communities. CONSENSUS PROCESS: A literature review, driven by research instruments from numerous organizations included reports and materials from the National Highway Traffic Safety Administration (NHTSA), American Academy of Pediatrics, National Committee for Injury Prevention and Control, U.S. Centers for Disease Control and Prevention (CDC), Mothers Against Drunk Driving (MADD), and the National SAFE KIDS Campaign. Both the Meharry Medical College report, Achieving a Credible Health and Safety Approach to Increasing Seat Belt Use Among African-Americans, and the U.S. Department of Transportation's Blue Ribbon Panel to Increase Seat Belt Use Among African Americans: A Report to the Nation, provided substantial background for the panel. More than 60 pieces of traffic safety literature have been examined to date. Based on the literature review, a short list of the most relevant issues affecting African Americans and traffic safety was devised. It includes: The disproportionately high rate of traffic-related injury and death among African Americans. The cost in health, monetary costs and other associated costs of traffic safety accidents and injuries. The number of traffic-related injuries and deaths that could be prevented if more African Americans observed good traffic safety practices. Barriers to practicing good traffic safety habits among African Americans. Failure of laws and public information campaigns to influence improved traffic safety practices among African Americans sufficient to reduce disparities in traffic-related injury and death. In July 2001, NMA convened a consensus panel of experts in St. Thomas, U.S. Virgin Islands, to review a briefing document summarizing the most salient traffic safety issues among African Americans. The panel elaborated on key issues, including existing policy and standards for the use of child restraint devices to secure infants and toddlers, existing data regarding disparities in traffic-related injury and death among African Americans, and the cultural, age and developmental appropriateness of existing safety campaigns. SUMMARY: Public information campaigns have successfully improved traffic safety practices among the general public but in large part have been unsuccessful among minority populations-including African Americans. This may be due to: A failure to use techniques and messages that are culturally sensitive to African Americans. Campaigns that have targeted geographic and social centers where African Americans are not broadly present. Lack of awareness of the disproportionate effect motor vehicle crashes are having on African Americans. Scientifically based, culturally appropriate intervention strategies need to be devised and implemented by African American institutions and organizations to improve traffic safety practices and reduce the high rate of traffic-related injury and deaths among African Americans.

Accidents, Traffic↗
PubMed2003

Cultural Perspectives on Korean American Cancer Control.

This paper emphasizes the importance of sociocultural research for successful ethnic-based cancer control. The article first delineates some demographic characteristics of Korean Americans and then describes six subcultural groups within this population, illuminating that Korean Americans are a diverse people. The author emphasizes that any cancer control program needs to acknowledge these cultural differences in selecting the target population, identifying intervention strategies, and training a team of health-care professionals, as well as in determining psychological factors related to cancer. The author also suggests that the traditional Korean American notion of health, the preventive approach to illness by using food as medicine, the traditional classification of body types, and the sasang theory for the treatment of illness are all important factors worthy of further research. Finally, the synchronistic and holistic approach to health common among Korean Americans is described by citing recent studies of cancer control that combine the use of Western medicine together with proper physical exercise, diet control, and psychological and family counseling.

Journal Article↗
PubMed1994

[Proportion of disease attributable to tobacco in the province of Granada].

BACKGROUND: Smoking is the main cause of preventable morbidity and mortality in Europe. The effect of smoking is not constant with the diseases related to it. The goal of this study is to estimate poblational etiologic fractions (PEF), as the proportion of disease attributable to smoking in the reference population, for those disease clearly related to smoking in Granada. METHODS: The PEF depend upon relative risk (RR) and the proportion of exposed subjects in the target population. Meta-analytic procedures, following the Woolf's method, were applied to estimate weighted RR between smoking and each one of the diseases studied. A survey on a random sample of all Granadian population to assess the prevalence of smoking was performed. RESULTS: The PEF were always higher for males than for females. In males, the highest figures were for lung cancer (85%) and chronic obstructive lung disease (84%); whilst in females lung cancer and peripheral artery disease reached the greatest figures, 55% and 51%, respectively. CONCLUSIONS: The figures obtained outline the need for improving antismoking campaigns and allow to quantify the maximum potential benefit to be got if smoking was quit by the Granadian population.

Adolescent↗
PubMed1995

Behavioral diagnosis of 30 to 60 year-old men in the Fabreville Heart Health Program.

To develop effective interventions in the Fabreville Heart Health Program, a behavioral diagnosis was conducted on a sample of 1,600 men 30 to 60 years of age residing in the Fabreville district of Laval, Quebec's second most populous city. The response rate of the self-administered postal questionnaire was 73.5%. The results indicate that dietary fat consumption, smoking and a sedentary lifestyle were more prevalent among the younger respondents, particularly those less-educated. The results underline the importance of segmenting the target population so that heart health interventions can respond to the specific needs of each sub-population. Furthermore, the data seem to suggest the need to adapt educational messages to the target lifestyle habits. The results showed that in terms of diet, consumption of meat and dairy products contributed the most to fat intake. Of the 30% who were smokers, a large proportion would be reluctant to stop the habit; 20% smoked 26 cigarettes or more a day, and more than half had already tried once or more to stop. Although 60% of respondents indicated they engaged in physical activity, only 37.0% did it regularly. These results demonstrate the need to clearly target specific behaviours and subgroups in our promotion messages for a healthy heart.

Adult↗
PubMed2004

Simulation of working population exposures to carbon monoxide using EXPOLIS-Milan microenvironment concentration and time-activity data.

Current air pollution levels have been shown to affect human health. Probabilistic modeling can be used to assess exposure distributions in selected target populations. Modeling can and should be used to compare exposures in alternative future scenarios to guide society development. Such models, however, must first be validated using existing data for a past situation. This study applied probabilistic modeling to carbon monoxide (CO) exposures using EXPOLIS-Milan data. In the current work, the model performance was evaluated by comparing modeled exposure distributions to observed ones. Model performance was studied in detail in two dimensions; (i) for different averaging times (1, 8 and 24 h) and (ii) using different detail in defining the microenvironments in the model (two, five and 11 microenvironments). (iii) The number of exposure events leading to exceeding the 8-h guideline was estimated. Population time activity was modeled using a fractions-of-time approach assuming that some time is spent in each microenvironment used in the model. This approach is best suited for averaging times from 24 h upwards. In this study, we tested how this approach affects results when used for shorter averaging times, 1 and 8 h. Models for each averaging time were run with two, five and 11 microenvironments. The two-microenvironment models underestimated the means and standard deviations (SDs) slightly for all averaging times. The five- and 11-microenvironment models matched the means quite well but underestimated SDs in several cases. For 1- and 24-h averaging times the simulated SDs are slightly smaller than the corresponding observed values. The 8-h model matched the observed exposure levels best. The results show that for CO (i) the modeling approach can be applied for averaging times from 8 to 24 h and as a screening model even to an averaging time of 1 h; (ii) the number of microenvironments affects only weakly the results and in the studied cases only exposure levels below the 80th percentile; (iii) this kind of model can be used to estimate the number of high-exposure events related to adverse health effects. By extrapolation beyond the observed data, it was shown that Milanese office workers may experience adverse health effects caused by CO.

Air Pollutants, Occupational↗
PubMed2003

High incidence and prevalence of HIV-1 infection in high risk population in Calcutta, India.

HIV-1 infection in India has been increasing steadily over the last decade. In the absence of potent antiviral therapy, estimates of HIV infection are needed to monitor the epidemic, institute prevention strategies in target populations and determine the suitable populations for vaccine studies. In this report we present the HIV-1 seroprevalence and annual estimates of seroincidence in a high risk population from Calcutta, the most populous city in the eastern part of India. In 1206 high risk subjects tested over two years between February of 1999 and December 2000, we have determined an overall seroprevalence of 40.1% using enzyme-linked immunosorbent assay followed by a confirmatory Western blot testing. Furthermore, using a newly described Standardized Testing Algorithm for Recent HIV-1 Seroconversion (STARHS), we have estimated an annual seroincidence rate of about 7% in this population during this two-year study. Such a high annual seroincidence rate makes this population well suited for studies of HIV-1 prevention, including vaccine trials.

Condoms↗
PubMed2003

Seroprevalence of HTLV-I and HTLV-II infection among immigrants in northern Italy.

To assess the prevalence of human T cell leukemia virus type I (HTLV-I) and 2 (HTLV-II) infection and the associated risk factors among immigrants living in Northern Italy, we surveyed 3017 open-population subjects from three geographical areas and 371 prisoners. In the open population, the overall prevalence was 0.3% for HTLV-I and 0.1% for HTLV-II, while among prisoners, HTLV-I and HTLV-II infection were detected in 1.4 and 0.8% of subjects, respectively. HTLV-I prevalence was higher in subjects with multiple sexual partners or sexually transmitted diseases. This association was significant in the open-population group and close to significance in prisoners. Multivariate analysis showed that human immunodeficiency virus (HIV) seropositivity remained significantly associated with HTLV-I infection in both targeted populations (OR: 11.2 in the open population; OR: 9.9 among prisoners), whereas sexual exposure was associated with HTLV-I seropositivity only for prisoners (OR: 14.3). No independent variable was related to HTLV-II infection.

Adult↗
PubMed2004

Transplantation of a combination of CD133+ and CD34+ selected progenitor cells from alternative donors.

Positive selected haematopoietic stem cells are increasingly used for allogeneic transplantation with the CD34 antigen employed in most separation techniques. However, the recently described pentaspan molecule CD133 appears to be a marker of more primitive haematopoietic progenitors. Here we report our experience with a new CD133-based selection method in 10 paediatric patients with matched unrelated (n = 2) or mismatched-related donors (n = 8). These patients received a combination of stem cells (median = 29.3 x 10(6)/kg), selected with either anti-CD34 or anti-CD133 coated microbeads. The proportion of CD133+ selected cells was gradually increased from patient to patient from 10% to 100%. Comparison of CD133+ and CD34+ separation procedures revealed similar purity and recovery of target populations but a lower depletion of T cells by CD133+ selection (3.7 log vs. 4.1 log, P < 0.001). Both separation procedures produced >90% CD34+/CD133+ double positive target cells. Engraftment occurred in all patients (sustained primary, n = 8; after reconditioning, n = 2). No primary acute graft versus host disease (GvHD) >/= grade II or chronic GvHD was observed. The patients showed a rapid platelet recovery (median time to independence from substitution = 13.5 d), whereas T cell regeneration was variable. Five patients are alive with a median follow-up of 10 months. Our data demonstrates the feasibility of CD133+ selection for transplantation from alternative donors and encourages further trials with total CD133+ separated grafts.

AC133 Antigen↗
PubMed1996

Subjective sleep characteristics of 1,485 males and females aged 50-93: effects of sex and age, and factors related to self-evaluated quality of sleep.

BACKGROUND: This epidemiologic study cross-sectionally examined the effects of sex and age on subjective characteristics of sleep and the factors related to self-evaluated sleep quality in a Dutch noninstitutionalized elderly population. METHODS: 1,692 sleep questionnaires were mailed to all attenders of the general practice serving Krimpen aan de Lek, The Netherlands, aged 50 or over. Both target population and responders (1,485 subjects) were virtually representative of the Dutch population regarding sex and age (50 +) characteristics. RESULTS: Overall, females reported significantly poorer quality of sleep, longer sleep latencies, more nighttime awakenings, less frequent napping, and more frequent use of sedative-hypnotic drugs when compared to males. Additionally, there was a female predominance in the prevalence of disturbed sleep onset and sleep maintenance, whereas a male predominance was observed in the prevalence of excessive daytime sleepiness. Across subjects, a significant age-related increment was found for sleep latency time and time spent in bed. The number of nighttime awakenings increased significantly with age only in males. No significant correlations were found between health status and sex, age, or subjective sleep quality. The most frequently reported causes of disturbed sleep onset and sleep maintenance were worries and nocturia, respectively. Subjective quality of sleep was mostly associated with self-estimated sleep latency. CONCLUSIONS: Our findings extend those of previous epidemiologic studies reporting that sleep disorders are common in the general elderly population. Future studies should further elucidate the nature and extent of geriatric sleep disorders to satisfy the increasing need for its accurate diagnosis and treatment.

Aged↗
PubMed1993

Development of a transcultural health education program for the Hmong.

CNSs face unique opportunities and challenges in meeting the health care needs of culturally diverse populations. As an education consultant involved in the development and implementation of a transcultural health education program, a CNS is required to have expert knowledge of the target population's health beliefs, values, and practices as well as knowledge of their language, level of literacy, and traditional teaching-learning styles. A critical consideration includes the use of a pluralistic model of education that addresses both the implicit and explicit conditions of learning and education. This paper describes the model and its application in the development and implementation of a health education program for the Hmong. The transcultural education process is examined and analyzed for appropriateness and effectiveness.

Health Education↗
PubMed2006

Power and sample size for testing associations of haplotypes with complex traits.

Evaluation of the association of haplotypes with either quantitative traits or disease status is common practice, and under some situations provides greater power than the evaluation of individual marker loci. The focus on haplotype analyses will increase as more single nucleotide polymorphisms (SNPs) are discovered, either because of interest in candidate gene regions, or because of interest in genome-wide association studies. However, there is little guidance on the determination of the sample size needed to achieve the desired power for a study, particularly when linkage phase of the haplotypes is unknown, and when a subset of tag-SNP markers is measured. There is a growing wealth of information on the distribution of haplotypes in different populations, and it is not unusual for investigators to measure genetic markers in pilot studies in order to gain knowledge of the distribution of haplotypes in the target population. Starting with this basic information on the distribution of haplotypes, we derive analytic methods to determine sample size or power to test the association of haplotypes with either a quantitative trait or disease status (e.g., a case-control study design), assuming that all subjects are unrelated. Our derivations cover both phase-known and phase-unknown haplotypes, allowing evaluation of the loss of efficiency due to unknown phase. We also extend our methods to when a subset of tag-SNPs is chosen, allowing investigators to explore the impact of tag-SNPs on power. Simulations illustrate that the theoretical power predictions are quite accurate over a broad range of conditions. Our theoretical formulae should provide useful guidance when planning haplotype association studies.

Computer Simulation↗
PubMed1996

Neuro-epidemiological pilot survey of an urban population in a developing country. A study in Bangalore, south India.

A feasibility study was conducted in an urban population of 3,040 in Bangalore, South India, to understand the baseline characteristics, evaluate screening questionnaires, identify potential problems and determine the magnitude of the problems. The target population was selected by a random method, from four census enumeration blocks of a specific urban area. A two-phase study design was adopted consisting of screening by trained field investigators in the initial stage and clinical examination by a neurologist in the second stage. The information was collected by an interview method on a house-to-house basis. Evaluation of the screening instruments yielded high sensitivity and specificity rates, and it became clear that there is a need to reduce false-positive results in the screening questionnaire for individuals above 7 years of age. The prevalence of neurological disorders was 32.8 per 1,000 population (with a rate of 7.8/1,000 for epilepsy). It appears feasible to detect a wide range of neurological disorders using the methods described.

Adolescent↗
PubMed2007

Autism in the Faroe Islands: an epidemiological study.

The Faroe Islands are considered to be a genetic isolate. This population study of the prevalence of autism sought to identify a representative cohort for future genetic studies. In 2002 all schools were screened for autism spectrum disorders. The target population were all children born in 1985 through 1994 and living in the Faroe Islands on December 31, 2002. Children who screened positive for autism characteristics were examined using the Diagnostic Interview for Social and Communication Disorders (DISCO). Of the children aged 8 through 17 years, 0.56% had childhood autism, Asperger syndrome or atypical autism. The male:female ratio was just under 6:1. The prevalence of autism in the Faroe Islands was very similar to that reported from many western countries.

Adolescent↗
PubMedDate not supplied

[Survey of satisfaction among health center users].

OBJECTIVES: To find out the satisfaction's level of the Nazaret (Valencia) Health Center's users; To detect the deficiencies in the areas under study; To find out whether or not there are differences with previous studies in primary care. DESIGN: Transversal study, results evaluation with no equivalent control group. SETTING: (site). Primary health care. Neighborhood of Valencia with 6749 people. With a regressive Sundbarg index, and the 42.6% of the population that are older than nine years are illiterate or with incomplete primary education, the income level index by neighborhood in 1986 is -5.6 (range: 13.4; -8.1). PARTICIPANTS TARGET POPULATION: all the Nazaret Health Center users. The inclusion criteria were: 1. Eighteen years old (or older) users. 2. That had contacted previously for whatever reason (administrative or sanitary) with the health center at least in one occasion during the prior 6 months. The random sample was selected for a 5% maximum error, a 95.5% confidence level, and a p < or = 30% for the negative answers from the scale, its size was 323 patients, with a 20% increase for forecasted no cooperation/no answers (n = 388). INTERVENTION AND RESULTS: The average age of the interviewed was 42 years. The total adding score was 98.1 (theoretical range: 27-135). The score by areas (theoretical range 9-45) was: personal quality area 35.5 professional competence 32.4 and the relationship cost-comfort 30.5. A total (overall) satisfaction item had an average of 7.2 on a 1 to 10 scale, with P10 = 5, P50 = 7, P90 = 10. The analysis of variance shows that satisfaction increases with age, with the attachment to the same doctor, with feminine sex, with unemployment and, with low educational level, being more critic the young people and the people with educational level (not significative difference). CONCLUSION: We consider that users have a good degree of satisfaction, that the ratio cost-comfort should be improved, there is a significative improvement compared with previous studies done with the former primary health care model.

Adolescent↗
PubMed1997

Accidents among high school pupils in Israel: a recurrent disease?

Accidents are unexpected events usually producing injury. Many victims of trauma have a history of recurrent accidents. This study is a preliminary effort to verify the hypothesis that accidents may be considered as a recurrent disease in certain families; these children and families belong to a 'high risk group'. Two-hundred seventy-nine high school pupils participated in the study. Every pupil had experienced 1.7(+/- 1.7) mild to serious injuries that necessitated medical treatment during the years of elementary and high school. The geographical location of accidents was as follows: 26.4% were on the road; 23.1% occurred at school; 28.6% were associated with sport activities; and 22% occurred at home. The prevalence of injuries among boys was higher than among girls. A correlation was found between the number of accidents of the pupils and those of close family members, suggesting that these children and families are prone to accidents and form a 'high risk group'. The knowledge of accident and injury prevention did not change significantly during high school studies. The principal source of knowledge of accident and injury prevention of the pupils were the media: TV (98.8%), newspapers: (65.6%), and radio (58.1%). The contribution of physicians and nurses to this knowledge was very slight (16.5%). These families should be a target population; an educational program should be organized and transmitted by the media; family meetings with educational advisors, physicians and nurses should take place at school, especially for these target families. As a preventive measure for all, and especially to the high risk group, we would suggest that high school pupils work for 1-3 months in rehabilitation centers in which they can see the consequences of accidents and thereby gain an understanding of the effects of injury on the patient and his family.

Accident Proneness↗
PubMed2006

Seven criteria for improving effectiveness trials in psychiatry.

BACKGROUND: There are no published criteria for improving the quality of effectiveness of randomized controlled trials (RCTs) in psychiatry. METHOD: The authors review and systematize the relevant literature on effectiveness trials, with particular reference to psychiatry. RESULTS: In planning effectiveness RCTs in psychiatry, seven sets of issues need to be carefully considered: (i) study question (i.e. is the study question expressed in an answerable way?); (ii) reference population (i.e. what is the reference group or subgroup to which the trial results should be generalized?); (iii) patient sample (i.e. how far does the sample reflect the target population?); (iv) study settings (i.e. how representative are the study settings of routine clinical sites?); (v) study interventions (i.e. is the study intervention manualized, acceptable to patients and suitable for widespread use?); (vi) control condition (i.e. are the key characteristics of the control condition well described, and do they vary within and between sites?); and (vii) bias (e.g. attrition, blinding, concealment, consent and contamination). CONCLUSIONS: More effectiveness trials are needed which have sufficient statistical power to provide precise answers to assist clinicians in making treatment decisions. The development of effectiveness trials in psychiatry, both for studies of individual treatments and for service evaluations, may be enhanced by carefully considering and justifying decisions in relation to each of the seven key headings proposed here.

Bias↗