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Reliability of psychiatric diagnosis. I. A methodological review.

This article reviews some methodological aspects of studies of diagnostic reliability in psychiatry. We define and discuss the concept of interrater reliability and review some of the ways in which the design of the reliability study can influence the results. Three basic methodological issues are raised, including: importance of structured interviews and objective diagnostic criteria, the importance of a test/retest vs an interviewer/observer design, and the calculation of reliability in a way that takes chance agreement into account.

Attitude of Health Personnel

Appraising the quality of drug-evaluation research: II. A methodological review procedure for prophylactic treatment trials.

The present paper describes a methodological review procedure for evaluating a body of research focusing on the study of a prophylactic treatment medication. An illustrative application of this procedure to research evaluating lithium prophylaxis for bipolar affective disorders revealed possible biases in respect to subject selection, and general problems with diagnostic reliability and the reliability of the dependent variable. A tendency to ignore the statistical power aspects of determining sample size was also noted, along with possible difficulties relating to infrequent assessments of patients' clinical conditions. The implications of these matters were discussed in terms of the unique vantage point offered by this methodological review process.

Bipolar Disorder

Short-course antibiotic therapy for urinary tract infections in children. A methodological review of the literature.

We performed a methodological review of 14 published clinical trials of short-course (less than or equal to 4 days) vs conventional (seven to ten days) antibiotic therapy for urinary tract infection in children. Four reviewers independently assessed each study, without knowledge of authorship, according to 35 criteria, 14 of which were considered critical for this type of study. Reviewer ratings were summed so that any study could receive a potential score of 140 for all criteria and 56 for the critical criteria. Only one study met more than 75% of all the criteria, whereas four studies met 75% of critical criteria. Two studies found short-course antibiotic therapy significantly less effective than conventional therapy. The remaining 12 had insufficient sample size to warrant the conclusion that the two therapies were equivalent. We conclude that there is insufficient evidence to warrant the use of short-course antibiotic therapy for urinary tract infection in children and that a much larger study, with attention to some of the details described, is warranted.

Anti-Bacterial Agents

A methodological review of non-therapeutic intervention trials employing cluster randomization, 1979-1989.

A methodological review is presented of 16 non-therapeutic intervention trials published over the last decade which have randomized intact clusters rather than individuals in treatment groups. Each of the trials was surveyed as to the information supplied on six methodological criteria. Although there is increasing recognition of the methodological issues associated with cluster randomization, many investigators are still not aware of the impact of this design on sample size requirements and analysis considerations. Investigators are urged to publish the cluster-specific event rates observed in their trials as a guide for the planning of future studies.

Cluster Analysis

A decade of case management: a methodological review of outcome research.

The last decade has witnessed a burgeoning interest in case management services to people with severe mental illness. While the literature on case management is proliferating, there remains a paucity of rigorously designed outcome research. This paper provides a methodological review of that outcome research on case management, which found that the term case management is used to describe a diverse array of interventions that yield differing client outcomes. Suggestions for the direction of future inquiry are described.

Adult

Health education interventions in developing countries: a methodological review of published articles.

Some 67 journal articles that described and evaluated health education programmes in developing countries were read by two independent reviewers who examined the methodology used in the studies. Of the articles 47% provided a sufficiently detailed description of the educational intervention to allow replication and 40% described the educational level of the intended audience. Only 21% were controlled studies employing sample sizes greater than 60 individuals or two clusters, although six studies used randomized or quasi-randomized designs. Of the studies 33% looked at changes in health status while another 33% used observable changes in health behaviour as an endpoint. There was good agreement between the reviewers on whether these characteristics were present. Only three of the articles contained all four methodological attributes described above. The results of these articles suggests that successful health education depends on using a few messages, of proven benefit, repeatedly, and in many forums. It is important to improve the methodological quality of health education research. This can be done by using controlled, preferably randomized, designs, ensuring adequate sample sizes, examining only objective changes in behaviour or, better yet, changes in morbidity or mortality. Research reports should describe in detail the educational intervention employed and the target audience.

Developing Countries

Editorial peer review: methodology and data collection.

This study reports on the editorial peer review practices of two categories of U.S. medical journals indexed in Index Medicus. Journals in group 1 were included on each of three lists of recommended journals, had a circulation of 10,000, and were cited at least 5,000 times per year. Group 2 journals, also indexed in Index Medicus, met none of the criteria. After being pretested, data were collected through a series of interviews and questionnaires. A summary of the methodology and an analysis of the differences between data collected through questionnaires and interviews is reported. The study concluded that initial interviews are very helpful in designing a questionnaire; a high percentage of editors agreed to be interviewed (100% for sixteen group 1 editors and 93.8% for sixteen group 2 editors); a 69.4% response rate to the mailed questionnaire indicates either sufficient follow-up or a high rate of interest in the subject matter; no trends identified by the questionnaire were reversed by changes in answers given during the interviews; approximately 11% to 15% of the answers differed between the questionnaire and interview methodology; and for some sensitive issues, editors were more likely to give answers on the questionnaire according to what was perceived as the most appropriate answer, rather than the actual practices of the journal.

Data Collection

A methodological review of "method skeptic" reports.

The literature purporting to demonstrate that clinical neuropsychology is of limited validity in the forensic setting is reviewed critically and alternative interpretations are discussed. The methodological, procedural, conceptual, data analytical and survey/research design limitations are evaluated.

Female

Health interview surveys in developing countries: a methodological review.

This review covers cross-sectional health interview surveys in which respondents were asked about their recent illness and their use of preventive and curative health services. Country survey results differed widely, for both morbidity prevalence estimates and health services utilization, reflecting major methodological differences as well as any true differences that may exist between the population groups studied. Comparison of morbidity and utilization rates is thus thwarted by the absence of standardization in survey methodology, methods of analysis, and the classification of results. A lack of theoretical studies upon which to base methodology choices combined with a general lack of rigor in applying the methodologies chosen has limited the interpretation of many surveys carried out to date. The review concludes with a series of specific recommendations for improving the survey methodology of future health interview surveys in less developed countries.

Cross-Sectional Studies

Association between indicators of perinatal asphyxia and adverse outcome in the term infant: a methodological review.

There are conflicting opinions about the significance of 5 perinatal findings felt to be indicators of asphyxia (meconium staining of the amniotic fluid, abnormal fetal heart rate patterns, acidotic fetal scalp blood gases, low Apgar scores, and acidotic cord blood gases). A review of the literature was undertaken to determine the strength of association of each of these findings with adverse outcomes. Although all studies contained methodological problems, these indicators were found to have strong associations with one or more adverse outcomes such as perinatal death, low Apgar scores or cerebral palsy. The strength of the association (relative risk) was found to vary inversely with the prevalence of the outcome.

Acidosis

The value of trauma centres: a methodologic review.

This review examines the rationale for the development of trauma centres in North America. The value of local and regional trauma care systems is considered, emphasizing study methodology. Evidence is acquired from case-series reports, before-and-after studies and intersystem comparisons. It overwhelmingly suggests that the main determinants of survival, given the severity of the injury, are the adequacy of the initial resuscitation and the early recognition of serious injuries. Thus, doctors involved in front-line trauma care, whether in the centre-city teaching hospital or in the rural community setting, must be properly prepared.

Humans

The treatment of primary and secondary orgasmic dysfunction: a methodological review of the literature since 1970.

This paper reviews the studies since 1970 which examined the treatment outcome of primary and secondary nonorgsmic women. The studies were evaluated within the following sections: subjects, therapists, time format, treatment, and outcome criteria. Many methodological deficiencies were found, most notably the lack of specificity regarding subject characteristics, a reliance on women's self-reports of outcome without obtaining partner validation, the failure to assess the influence of the woman's partner on her orgasmic responsivity, the failure to control for expectancy factors, and the use of different criteria for treatment success. The problems in the literature suggest that it is premature to place any confidence in the identification of the treatment format which is most successful for a defined population of women who experience a specific form of primary or secondary orgasmic dysfunction. The data tentatively suggest that (1) secondary nonorgasmic women would show greater gains than primary nonorgasmic women in treatments emphasizing sexual and nonsexual communication techniques, (2) primary nonorgasmic women would show greater gains than secondary nonorgasmic women in desensitization and sexual technique training procedures, (3) desensitization may be the appropriate treatment for women whose sexual anxiety contributes to secondary orgasmic dysfunction. These hypotheses should be examined in controlled research.

Desensitization, Immunologic

Monitoring chemical exposure using breast milk: a methodological review.

Retrospective exposure assessments are often a major weakness in environmental epidemiologic studies. Many environmentally important chemicals are persistent lipophilic compounds which partition into fat and breast milk. The analysis of these chemicals in breast milk provides a noninvasive means of collecting large volumes of a biologic fluid that correlates well with body burden. This may provide an integrated measure of cumulative absorption over several years which can be used to assess exposure in several different epidemiologic study designs. However, consideration of toxicokinetic principles in the study design is important in order to allow for maternal and other factors unrelated to exposure which may influence breast milk concentrations. These factors include maternal age, parity, maternal body weight, time of sampling during the lactation period, and fat content of the breast milk. Failure to use standardized entrance criteria and to allow for the above factors in the analysis and interpretation of the study results may lead to invalid conclusions regarding past exposures. Allowance must also be made for the restrictions on the sampling frame available in any epidemiologic study using breast milk analysis. Published studies to date often have had several methodological deficiencies. With the introduction of biologic specimen banks, breast milk collection and analysis should play an important role in future epidemiologic studies, especially those investigating health outcomes in infants.

Body Weight

The metric analysis of three-dimensional dendritic tree patterns: a methodological review.

Metric analysis methods used to study neuronal arborizations are reviewed and discussed. The analysis methods considered are those examining the spatial orientation and density of the whole dendritic field of a neuron, the metrics of dendritic segments and the bifurcation angles. General variables indicating the size of the soma and the dendritic field are indicated. In addition, the instrumentation used for providing 3-dimensional data for metric analyses and the shrinkage of Golgi-stained neurons are discussed.

Animals