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[Methodology of diagnostic validation studies. Errors in study planning and evaluation].

The evaluation of diagnostic tests play an important role in clinical research. Though detailed standards have been developed for treatment evaluation, widely accepted methodological standards in diagnostic test research are still lacking. Following recent methodological research German biostatisticians usually distinguish between 4 types of diagnostic validation studies (Phase I to IV). The diagnostic value of a test can be described by indexes like sensitivity, specificity and predictive values. Sensitivity and specificity are so-called nosological probabilities whereas predictive values describe the probabilities of the disease given a positive or negative test result, respectively. These posterior probabilities depend on the prevalence of the disease in question. The methodological problems that arise in the planning of diagnostic studies differ from those encountered in treatment evaluation. This contribution presents an annotated checklist of the most important faults and shortcomings in the planning and the analysis of diagnostic validation studies. Avoiding these deficiencies may help that the study results are accepted by biostatisticians, clinicians and cost units.

Bias↗

The potential of phosphorescence spectrometry in clinical chemistry--the new generation of instrumentation and methodology.

We review recent advances in instrumentation and methodology in phosphorimetry that should facilitate the use of phosphorimetry for clinical analyses and recent phosphorescence studies of interest to the clinical chemist. We indicate recent advances, particularly improvements in instrumentation, novel methodologies, and new chemical processes that result in either an increase in sensitivity or selectivity (or both) of measurement of compounds of clinical importance. The greatest use of phosphorimetry in the clinical laboratory will not be for the analysis of very large numbers of samples for one species via automatic instrumentation, but rather will be for the analysis of those molecular species difficult or impossible to measure by conventional methods (colorimetry, fluorometry, etc.). Although various instrumental and methodological advances are discussed separately here, the most important use of these advances in clinical chemistry will undoubtedly be when two or more of them are combined, for example, in the use of time- or frequency-resolved phosphorimetry for the selective measurement of the phosphorescence resulting with inorganic probes and the appropriate choice of solvent and pH (of course, the instrument could contain an image vidicon detector for rapid determination of the spectrum, the decay curve, or both).

Antimetabolites↗

[Disorders of emotional processes in schizophrenia: methodological aspects of research].

The paper discusses the status of current knowledge concerning methodology of emotional processes in schizophrenia. The authors tried to systematize and categorize the methods used in research aimed at emotions based on clinical observation, the results of experimental work, neuropsychological knowledge, and the newest techniques of neuroimaging. Consolidation of knowledge concerning perception of emotional information and expression of emotions using mimery, gestures, and affective intonation of verbal expression was performed. The data concerning perception and expression of emotions were presented in facial, prosodic, and lexical aspects. The authors paid particular attention to the methodological controversies and the challenges in studies on emotions, the awareness of which may be helpful in reaching methodological correctness.

Humans↗

[International practice guidelines on the management of osteoporosis-- assessment of methodologic quality].

To a growing extent evidence-based clinical practice guidelines are considered helpful in supporting high quality medical care. Our study assessed the methodological quality of 20 clinical practice guidelines on the management of osteoporosis. Results indicated that only 2 out of 20 guidelines were developed with sufficient methodological rigour to be called evidence-based--none of them from Germany. Comparative reports including quality assessments may not only be helpful for clinicians to choose an appropriate guideline for their daily practice but also to stimulate guideline developers to use more rigorous methodology.

Cross-Cultural Comparison↗

[Is evidence-based medicine really a craze? Surely it is fashionable to criticize it. A methodologic comment from the Centro Italiano per la Medicina Basata sulle Prove (Italian Center for Proof-Based Medicine)].

Evidence Based Medicine (EBM) represents the methodological search for the best solution of a clinical problem, using the most relevant scientific acquisitions of biomedical research, collected and critically appraised in the light of the experience and expertise of physicians. This search is targeted to individual patient care, in the frame of risk/benefit and cost/effectiveness ratios. EBM approach constitutes a precious tool for applied clinical practice, and can also represent a useful methodological instrument for the complete management of patients. The impetus given to outcome studies, to effectiveness studies, to careful attention for outpatients, to the individual data (of the patients of controlled trials) analysis is a major merit of EBM. Many authors nowadays consider EBM just a fashion, and today denigrating EBM appears a fashion too. Medicine complexity is enormous, and EBM can provide a useful methodological approach to this same complexity. EBM is not the automatic solution for every clinical problem, but is a logical tool for the critical evaluation of the relevance of biomedical research results and for the judgment of their applicability into daily clinical practice.

Decision Support Techniques↗

Q methodology--a journey into the subjectivity of human mind.

AIMS: This paper introduces a relatively new research methodological tool, known as Q method, useful in exploring issues related to human subjectivity. DESCRIPTION: Q methodology is unique as it combines the strengths of both qualitative and quantitative research traditions. The sequential steps involve generation of ideas about the research topics, clarification and refinement of the ideas, and rank ordering these ideas by the respondents in a quasinormal distribution. The data are extracted with by-person factor analysis and useful in exploring arrays of attitude either cross-sectionally or longitudinally over a period of time. CONCLUSION: Q methodology can be used to analyse opinions, perceptions, and attitudes in both clinical and non-clinical settings. It is a preferred method of human subjectivity study as it provides more in-depth analysis of complex subjectivity issues.

Data Interpretation, Statistical↗

Methodology of the 1997 New Zealand National Nutrition Survey.

AIMS: To describe the development and use of the methodologies in the 1997 New Zealand National Nutrition Survey (NNS97). METHODS: NNS97 was a voluntary cross-sectional population survey conducted over a twelve month period on 4,636 non-institutionalized urban and rural New Zealand residents aged fifteen years and older. Survey data were collected in the participants' home and included: a self-administered qualitative food frequency questionnaire, including questions on food preparation habits; a three-pass 24-hour diet recall; interviewer-administered questions on diet supplement use, barriers to dietary change and participant perception of household food security; physical measurements including weight, height, three circumferences, two skinfolds and elbow breadth; blood pressure; and a blood sample to determine cholesterol and iron status. RESULTS: New methodologies developed for NNS97 included a computer based interview system, probability analyses for estimating prevalence of inadequate intake of selected nutrients, determination of iron status by both dietary and biochemical assessment, assessments of dietary supplement use and food security. A full range of quality control procedures at each stage of the data collection were also initiated. CONCLUSION: NNS97 has improved on previous New Zealand national nutrition survey methodologies, particularly with direct data capture and rigorous quality control procedures used in the collection of survey data.

Adolescent↗

Systems analysis and design methodologies: practicalities and use in today's information systems development efforts.

Historically, systems analysis and design methodologies have been used as a guide in software development. Such methods provide structure to software engineers in their efforts to create quality solutions in the real world of information systems. This article looks at the elements that constitute a systems analysis methodology and examines the historical development of systems analysis in software development. It concludes with observations on the strengths and weaknesses of four methodologies and the state of the art of practice today.

Computer-Aided Design↗

Evolving methodologies in bipolar disorder maintenance research.

Background During the development of a new treatment for bipolar disorder, maintenance studies are used to evaluate the ability of the putative mood stabiliser to prevent relapse and recurrence of further episodes. Comparisons with the early bipolar disorder maintenance studies indicate that the methodologies of recent trials have evolved substantially. Aims To review the methods used in the first- and second-generation maintenance studies, highlighting the differences of the various designs. Method Literature review. Results Methods that have evolved the most include patient enrolment, randomisation schemes and the use of outcome measures and statistical analyses. In addition, regulatory and commercial issues have also influenced study design. Conclusion There is little consensus on the methodology of bipolar disorder maintenance studies. As the integration of newer therapies into routine clinical practice is dependent on the evidence from controlled studies, it is essential that future maintenance trials in bipolar disorder achieve adequate methodological rigour without sacrificing overall feasibility.

Journal Article↗

A methodology to evaluate water and wastewater treatment plant reliability.

Evaluating the reliability of treatment processes and treatment facilities should be an important part of the planning and design process for water resource, wastewater treatment, and particularly wastewater reuse projects. With the recent developments in technology, particularly the development of membrane processes and alternative disinfection processes for water and wastewater treatment, there is an increasing need for a common methodology to evaluate the reliability of alternative processes and treatment facilities that utilize different combinations of those processes. To assess the reliability of a treatment facility, several aspects of treatment must be considered including a methodical evaluation of both mechanical reliability and plant performance. A straightforward method for conducting these types of analyses is described herein along with a description of applications of this methodology. A discussion is provided highlighting the value of such a methodology for both the water quality engineer and the risk manager.

Data Interpretation, Statistical↗

Evolving methodologies in bipolar disorder maintenance research.

BACKGROUND: During the development of a new treatment for bipolar disorder, maintenance studies are used to evaluate the ability of the putative mood stabilizer to prevent relapse and recurrence of further episodes. Comparisons with the early bipolar disorder maintenance studies indicate that the methodologies of recent trials have evolved substantially. AIMS: To review the methods used in the first- and second-generation maintenance studies, highlighting the differences of the various designs. METHOD: Literature review. RESULTS: Methods that have evolved the most include patient enrollment, randomisation schemes and the use of outcome measures and statistical analyses. In addition, regulatory and commercial issues have also influenced study design. CONCLUSION: There is little consensus on the methodology of bipolar disorder maintenance studies. As the integration of newer therapies into routine clinical practice is dependent on the evidence from controlled studies, it is essential that future maintenance trials in bipolar disorder achieve adequate methodological rigour without sacrificing overall feasibility.

Antimanic Agents↗

[Selected methodological problems of the history of medicine in the countries of former USSR].

The author has presented changes, which has taken place in methodology of medicine historical studies in the countries of former USSR. He has underlined mistakes, which originated in result of faulty methodological assumptions adopted. At the same time he has shown these changes as a natural occurrence, connected with development of sciences, but also as the result of political transformation and departure from dogma of Marxist methodology.

Historiography↗

Induction of hypotheses concerning hip arthroplasty: a modified methodology for medical research.

OBJECTIVES: The objective of this study is to advocate a methodology for medical research that, in contrast to traditional medical methodology, exploits the flexibility of machine learning and retains the kind of statistical tests that are generally accepted in the medical field for the confirmation of hypotheses. METHODS: First, the medical problem is defined and data for an observed population are collected; then a machine learning tool is used to generate hypotheses regarding the problem; finally, statistical methods are used to determine the validity of the generated hypotheses. RESULTS: To illustrate this approach, the problem of defining indications for hip arthroplasty after an acute medial femoral neck fracture is investigated as a case study. CONCLUSIONS: The methodology is similar to the usual style of applying machine learning, but insists on a link to the techniques of statistical tests that are normally used in medicine. It aims at a more flexible and economical use of experimental data than in the usual medical research, which is enabled by techniques of machine learning. At the same time, by reference to traditional statistical tests, it is hoped that this approach will lead to improved acceptance of machine learning in the medical field.

Aged↗

[Assessment of methodological quality of clinical performance measures].

One of the tasks of the federal "Coordinating Committee" within Germany's self-governing health care system is to develop clinical performance measures. Since these performance measures usually exert an enormous influence on health care delivery their methodological quality should meet highest standards. The aim of our study was to develop quality requirements for clinical performance measures to be used in Germany; we did this mainly by compiling internationally published criteria. We present lists of quality requirements for clinical performance measures and performance assessment programs as well as a checklist for documenting and assessing comprehensively the methodological quality of these measures. Developing clinical performance measures by using these criteria could improve their methodological quality and promote the objectivity of performance assessment in medical care.

Delivery of Health Care↗

Methodology for rendering household budget and individual nutrition surveys comparable, at the level of the dietary information collected.

OBJECTIVE: To describe the methodology applied in order to render comparable, at the level of the dietary information collected, the household budget survey (HBS) and individual nutrition survey (INS) data from four European countries (Belgium, Greece, Norway and the United Kingdom). SETTING: In Belgium, data from the HBS of 1987-88 were compared with data from the Belgian Interuniversity Research on Nutrition and Health collected from 1980 to 1985. In Greece, data from the HBS undertaken in 1993-94 in the greater Athens area were compared with data collected around 1994 in the same region, in the context of the Greek segment of the European Prospective Investigation on Cancer and Nutrition study. In Norway, data from the HBS carried out in 1992, 1993 and 1994 were compared with the NORKOST study conducted in 1993-94. In the United Kingdom, data from four HBSs carried out in 1985, 1986, 1987 and 1988 were compared with the National Dietary and Nutritional Survey of British adults conducted in 1987-88. DESIGN: INS-generated data were converted into 'HBS-like' estimates with the application of yield factors for weight changes during cooking, recipe-based calculations and edible proportion coefficients taking into account weight changes during the food preparation. The 'HBS-like' estimates thus obtained were compared with the original HBS values, after applying an adjustment factor for food spoiled or given to pets. CONCLUSION: The methodological considerations overviewed in the present paper indicate that a number of issues need to be taken into account before a proper comparison of the dietary data collected through surveys implemented with varied methodologies is carried out.

Belgium↗

Utilising field assignments in survey methodology course at Ziauddin Medical University, Karachi.

OBJECTIVE: To describe the teaching-learning strategy employed in the module of Survey Methodology for undergraduate medical students at Ziauddin Medical University. SETTING: Medical students of Ziauddin Medical University, Clifton, Karachi. METHODS: The objectives of the Survey Methodology course were developed so that a student would be able to design and conduct a small survey independently. For this purpose the students were required to participate in a census survey of a squatter settlement. The questionnaire for the survey was developed with the students, which included the demographic information of the households. It was discussed and pretested with the medical students. The students edited and entered the data on computer using Epi-Info. They were trained in sampling methods, data collection, data editing and entry through lectures and small group sessions. At the end of the course, students filled the course evaluation form. RESULTS: Out of 117 students who responded, 63% found the course to be useful. Small group sessions were regarded as the most helpful teaching strategy by 91% of the students. Majority (74%) of the students recommended that field visits should be a part of teaching strategy. CONCLUSION: The Survey Methodology course reinforces the importance and practical application of research methods. The students appreciate the course especially the small group sessions and the field visits.

Adult↗

Resource selection for an interdisciplinary field: a methodology.

The Health Sciences and Human Services Library of the University of Maryland developed and implemented a methodology to evaluate print and digital resources for social work. Although this methodology was devised for the interdisciplinary field of social work, the authors believe it may lend itself to resource selection in other interdisciplinary fields. The methodology was developed in response to the results of two separate surveys conducted in late 1999, which indicated improvement was needed in the library's graduate-level social work collections. Library liaisons evaluated the print collection by identifying forty-five locally relevant Library of Congress subject headings and then using these subjects or synonymous terms to compare the library's titles to collections of peer institutions, publisher catalogs, and Amazon.com. The collection also was compared to social work association bibliographies, ISI Journal Citation Reports, and major social work citation databases. An approval plan for social work books was set up to assist in identifying newly published titles. The library acquired new print and digital social work resources as a result of the evaluation, thus improving both print and digital collections for its social work constituents. Visibility of digital resources was increased by cataloging individual titles in aggregated electronic journal packages and listing each title on the library Web page.

Books↗

Applying methodological search filters to CAB abstracts to identify research for evidence-based veterinary medicine.

OBJECTIVE: The study sought to determine whether methodological search strategies identified by Haynes et al. as most effective for locating information for evidence-based medicine in MEDLINE would be effective in locating information in CAB Abstracts for evidence-based veterinary medicine. METHODS: Articles published in the year 2000 volumes of the Journal of the American Veterinary Medical Association and Veterinary Record were manually examined and classified by format (original study, review, general article, conference report, decision analysis, case report) and purpose category (etiology, prognosis, diagnosis, and treatment or prevention). Search strategies identified by Haynes et al. were then modified and run on the CAB Abstracts database. Sensitivity and specificity were determined by comparing results to the manual review of the literature. RESULTS: The author manually reviewed 390 articles, 289 articles of which were identified as original studies. Overall, the sensitivity and specificity of the search strategies were disappointing. DISCUSSION: The methodological search strategies developed by Haynes et al. for MEDLINE were not effective in locating literature for evidence-based veterinary practice in CAB Abstracts. A study examining methodological search strategies for identifying research for evidence-based veterinary practice in the CAB Abstracts database is necessary.

Databases, Bibliographic↗