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PubMed2003

Standard outcome metrics and evaluation methodology for disease management programs. American Healthways and Johns Hopkins Consensus Conference.

Disease management is conceptually recognized as being a significant approach for closing the gaps in care identified by the Institute of Medicine as contributing to poor outcomes from our health care system. That conceptual credibility has been bolstered by the disease management industry through the adoption of an industry-standard definition of disease management and through the development and implementation of disease management accreditation programs by the National Committee for Quality Assurance, Utilization Review Accreditation Commission, and Joint Commission on Accreditation of Healthcare Organizations. The clinical and financial outcomes of disease management programs continue to be suspect, however, due to the lack of an industry standard set of outcomes metrics and a uniform methodology for evaluating those metrics. As a result, the ability to evaluate the effectiveness of any individual program is compromised, and the ability to effectively compare results across programs of different delivery designs is non-existent. To address this issue, American Healthways and Johns Hopkins convened a consensus conference of nearly 150 health care professionals representing health plans, hospitals, practicing physicians (both primary care and specialty), and other health care professionals. The conference purpose was to develop a "first-step" set of metrics and a uniform methodology that could be applied industry-wide to enable meaningful comparisons between programs and to allow evaluation of individual programs whether "homegrown" or "outsourced." The consensus conferees recognized that there were many paths to this objective, but that they had to land on a set of metrics and a methodology that was "doable" in light of today's technology and data availability. The results of their consensus effort follow.

Disease Management↗

PubMed1999

Contraceptive introduction reconsidered: a new methodology for policy and program development.

Although new contraceptive technology has the potential for providing women with expanded options for fertility control, the historical record of international family planning shows that, in practice, introduction of new methods has not always broadened reproductive choice. Using the example of introduction of intrauterine devices into the Indian family planning program in the 1960s, we show that an exclusive focus on the technology itself is problematic and argue that methodologies are needed that relate introduction of new methods to user needs and program capacities. We summarize key findings from the Indonesian experience with Norplant introduction. Although an effort was made to address problems with previous approaches, major deficiencies in both the technical and interpersonal dimensions of care arose when the implants were made broadly available within the program. We subsequently present a methodology for contraceptive introduction developed by the World Health Organization. This methodology emphasizes the social and institutional context in which technology is used and suggests a participatory and research-based approach to program and policy development. We illustrate results from this new approach in its implementation in Vietnam and suggest areas for further evaluation.

Contraception↗

PubMed1994

Approaches to analysis of dietary data: relationship between planned analyses and choice of methodology.

Dietary intake cannot be estimated without error and probably never will be. The nature and magnitude of the error depends on both the dietary data collection methodology and the subjects studied. The impact of particular types of error depends on the question being asked and the analytical methodology used to address it. Examples of these phenomena are presented in this review paper. The future lies in improved estimation and understanding of the error terms and in the development of analytical and statistical methods of coping with these error terms rather than with "improvements" in dietary methodology per se.

Data Collection↗

PubMed2003

Citation indexes do not reflect methodological quality in lung cancer randomised trials.

BACKGROUND: Citation factors are applied to assess scientific work despite the fact that they were developed commercially in order to compare competing journals. The aim of the present study was to determine whether there is a relationship between citation factors and a trial's methodological quality using published randomised trials in lung cancer clinical research. Material and methods All of the randomised trials included in nine systematic reviews performed by the European Lung Cancer Working Party (ELCWP) were assessed using two quality scales (Chalmers and ELCWP). RESULTS: One hundred and eighty-one articles were eligible. The median overall ELCWP and Chalmers quality scores were 61.8% and 49.0%, respectively, with a correlation coefficient (r(s)) of 0.74 (P <0.001). A weak association was observed between citation factors and quality scores with the respective correlation coefficients ranging from 0.18 to 0.40 (ELCWP scale) and from 0.21 to 0.38 (Chalmers scale). American authors published trials significantly more often in journals with high citation factors than European or non-American authors (P <0.0001), despite no better methodological quality. Positive trials, which were significantly more likely to be published in journals with higher citation factors, were of no better quality than negative ones. CONCLUSION: Journals with higher citation factors do not appear to publish clinical trials with higher levels of methodological quality, at least for trials in the field of lung cancer research.

Chi-Square Distribution↗

PubMed2026

Standardization Challenges in Glycated Albumin Measurement: Methodological Heterogeneity and Quantification Discrepancies.

BACKGROUND: Glycated albumin (GA) is a valuable biomarker for monitoring glycemic status. However, measurement standardization is challenged by methodological heterogeneity, where different analytical principles and target measurands cause quantification discrepancies. This study systematically compared prevailing methodologies to identify a robust reference measurement procedure for widespread standardization. METHODS: We compared a targeted bottom-up proteomics method (ID-LC-MS/MS) with an enzymatic assay and the Japan Society of Clinical Chemistry (JSCC) reference method. A cohort of 129 donor serum specimens and certified reference materials (JCCRM-611) were analyzed to assess methodological comparability. Furthermore, GA concentration-dependent glycation kinetics at the Lys-525 site of albumin was examined. RESULTS: The optimized targeted bottom-up proteomics method showed a strong correlation (r = 0.986) with both the enzymatic assay and JSCC reference method. However, a progressively increasing negative systematic bias was observed at higher GA levels, confirming that Lys-525 underestimates GA at higher levels. In addition, with increasing overall GA concentration, the glycation ratio at the Lys-525 site consistently declined compared to the total glycated lysine residues. CONCLUSIONS: The standardization of GA measurements requires a precise, universally accepted definition to address analytical discrepancies. The present results indicate that quantification targeting all glycated lysine residues (as in the JSCC method) aligns more closely with biologically relevant GA values than site-specific measurement at Lys-525, which shows greater bias at higher concentrations. Therefore, further GA standardization would focus on adopting total glycated lysine residues on albumin as the preferred measurand definition, to improve detection accuracy and clinical comparability.

Serum Albumin↗

PubMed2006

Expert consensus document on arterial stiffness: methodological issues and clinical applications.

In recent years, great emphasis has been placed on the role of arterial stiffness in the development of cardiovascular diseases. Indeed, the assessment of arterial stiffness is increasingly used in the clinical assessment of patients. Although several papers have previously addressed the methodological issues concerning the various indices of arterial stiffness currently available, and their clinical applications, clinicians and researchers still report difficulties in selecting the most appropriate methodology for their specific use. This paper summarizes the proceedings of several meetings of the European Network for Non-invasive Investigation of Large Arteries and is aimed at providing an updated and practical overview of the most relevant methodological aspects and clinical applications in this area.

Adult↗

PubMed1990

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↗

PubMed1990

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↗

PubMed2000

Methodology for sampling questing nymphs of Ixodes ricinus (Acari: Ixodidae), the principal vector of Lyme disease in Europe.

To assess the Lyme borreliosis vector population density we set up a methodology for sampling the Ixodes ricinus L. population host questing on the vegetation. We focused on the collection of the nymphal stage, which is the principal stage of disease transmission to humans. This study was carried out in Rambouillet forest (Yvelines, France) where seven study areas were demarcated. These areas are maximally homogeneous for plant species using a finer scale than the phytosociological classification as defined by the method of landscape diagnostics. Out of 23 collections performed from March 1997 to May 1998, 2,906 I. ricinus nymphs were collected. The sampling technique chosen was the cloth lure technique. The technical parameters were studied and fixed (cloth type, cloth size, sample size, researcher position). It appeared that toweling was the best cloth type to optimize the number of ticks collected; the position of the researcher had no effect on tick samples. To satisfy the criteria for correct sampling, we studied representativity, randomness, and nonselectivity of our methodology. The spatial distribution of nymphs in a homogeneous area was close to random and thus very few subsamples were needed to obtain a relative density which was representative. No significant differences were found between random samples and following transect samples; and nonselectivity was totally satisfied because we only worked on questing nymphs. We grouped the samples that presented no significant differences to attribute a density index, which varied from 0 to 5. This methodology, applied with the same parameters, offers potential for producing comparable results from studies in different geographical areas and at different times of the years.

Animals↗

PubMed1996

Conceptual and methodologic issues in quantifying perceptual accuracy in childhood asthma.

Delineated methodologic issues in the study of symptom perception in childhood asthma. A review of past and recent psychophysiological and clinical studies of both adults and children presents the methodologic and analytic approaches that have been applied to quantify perceptual accuracy. Peak expiratory flow rate, forced expiratory volume in the first second, and force expiratory flow can serve as objective measures of asthma. A visual analog scale, a numerical guess, and a categorical description as subjective measures all have clear strengths and weaknesses. Correlational analysis of subjective-objective data, arithmetic differences between subjective guess and objective value, and an error grid categorization can each be applied to calculate an accuracy index on an individual subject. Illustrative examples reveal that the same data lead to different indices depending on the method chosen. Empirical research is needed to standardize various methodologic approaches. Given the increasing prevalence, severity, and morbidity of pediatric asthma, the study of symptom perception may be a critical component in our understanding of asthma management, and will likely lead to useful clinical interventions.

Adolescent↗

PubMed1999

The restriction site mutation assay: a review of the methodology development and the current status of the technique.

The restriction site mutation (RSM) assay has been employed in our laboratory, as a mutation detection system, since its first description in 1990. In principle the technique is capable of detecting mutations in ubiquitous restriction enzyme sites and is, therefore, readily applicable to any sequenced gene and/or organism. The RSM assay has been applied in our laboratory in various species, detecting rare mutations induced in mouse, rat, Xenopus, flatfish and human cells and tissues. This paper reviews the data accumulated by the RSM methodology in our hands and charts the developmental processes which have steadily improved the technique such that it is now applicable as a sensitive genotypic mutation detection system. This paper also includes PCR primer sequences and restriction enzymes employed in mutational analyses performed in the various species studied. We detail a variety of problems associated with the assay and the steps taken to solve them. The specific hurdles which have been overcome include the lack of quantitative data, the question of the contribution of DNA adducts to the induced mutation profile and the presence of false positives. Finally, the methods which have been developed to increase the sensitivity of the assay are also detailed. This paper describes our recommended RSM methodology, as it is routinely employed in our laboratory, which enables the analyses of mutations induced by chemical exposures and spontaneous endogenous processes. Our aim in presenting the developmental data on the RSM assay is to provide other researchers with sufficient information about the RSM methodology to facilitate its application in mutation analysis in other genes and organisms.

Animals↗

PubMed2003

Methodology for evaluation of possible consequences of accidental atmospheric releases of hazardous matter.

Sites exist with high levels of risk of accidental atmospheric releases. These releases can be hazardous nuclear, chemical, and biological matter. Such accidents may occur during transport of waste, or they may be due to natural hazards, human errors, terror acts or various operations at high risk. Considering the operation of lifting and transport of the sunken Kursk nuclear submarine as an example, a methodology for risk assessment is described. This methodology includes two approaches: (1) probabilistic analysis of possible atmospheric transport pathways using trajectory modelling, and (2) evaluation of possible contamination and consequences using real-time operational atmospheric dispersion modelling. The first approach can be applied in advance of an operation during the preparation stage, the second in real time during the operation stage. For the cases considered in this study, the results of trajectory modelling are supported by the operational dispersion modelling, i.e., the westerly flow is dominant during fall occurring 79% of the time. Hence, September-October 2001 was more appropriate for the lifting and transport of the Kursk nuclear submarine in comparison with summer months, when atmospheric transport toward the populated regions of the Kola and Scandinavian Peninsulas was dominant. The suggested methodology may be applied to any potentially dangerous object involving a risk of atmospheric release of hazardous material of nuclear, chemical or biological nature.

Accidents↗

PubMed2003

Neurocognitive assessment in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project schizophrenia trial: development, methodology, and rationale.

Patients with schizophrenia are severely impaired in crucial aspects of neurocognitive function. This impairment is the strongest clinical correlate of poor long-term outcome and adaptive dysfunction. Reports of neurocognitive enhancement with second generation antipsychotic medications have thus offered promise for improvement in the long-term outcome of patients with schizophrenia. However, the majority of these studies have had serious weaknesses in methodology, such as open-label design, small samples, or inappropriate dosing of medications. More recent studies have addressed these methodological issues but have been of short duration and have largely been sponsored by pharmaceutical companies. The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project is a unique opportunity to address the comparative neurocognitive effectiveness of available antipsychotic medications. This article describes the neurocognitive methods used in the schizophrenia trial of the CATIE project, including the selection and training of neurocognitive raters, patient inclusion criteria for assessment, rationale for the choice of neurocognitive instruments, and methodology for each neurocognitive test.

Antipsychotic Agents↗

PubMed1992

The dual-task methodology and assessing the attentional demands of ambulation with walking devices.

The purposes of this article are (1) to provide a preliminary examination of the attentional demands of ambulating with two commonly prescribed walking aids (a standard walker and a rolling walker) and (2) to introduce the dual-task methodology to the physical therapy community. Five subjects familiar with the appropriate use of the walkers and five subjects uninformed as to the correct use of the walkers participated in the study. Each subject completed the three phases of the experiment: (1) performing the reaction time (RT) task only; (2) performing each of the walking tasks only; and (3) performing each of the walking tasks in conjunction with the RT task, which constituted the dual-task conditions. The findings indicated that walking aided by either the rolling walker or the standard walker was highly attention demanding. More importantly, it appears that greater attentional demand was required when ambulating with the standard walker. These results are discussed with respect to the gait modifications and accuracy demands required when using these walkers. The usefulness of the dual-task methodology as a research tool for addressing clinically oriented questions is emphasized, and some potential applications of this methodology for the therapist within the clinic are discussed.

Adult↗

PubMed2004

Methodology and tools for source term assessment in case of emergency.

By looking at the power plant state of fission product barriers and critical safety systems, the magnitude of a potential radioactive release could be predicted in a timely manner to allow emergency response to be executed even before the occurrence of a release. This is the perspective in which the development of ASTRID methodology and tool is performed. The methodology maps out, for several reactor types as well as reactor containments, relevant process parameters and indicators, what and how to calculate and a structured way to summarise and conclude on potential source term and likely time projections. A computer tool is proposed to support the methodology, to suite different user situations, both on-site and off-site as well as size of staff, priority and work order. The output from such an assessment is intended to, first, give bases for decisions on necessary urgent protective actions pre-release, and, second, an input for the sophisticated dispersion calculation codes.

Computer Simulation↗

PubMed1997

An international study on sleep disorders in the general population: methodological aspects of the use of the Sleep-EVAL system.

The comparability among epidemiological surveys of sleep disorders has been encumbered because of the array of methodologies used from study to study. The present international initiative addresses this limitation. Many such studies using the exact same methodology are being completed in six European countries (France, the United Kingdom, Germany, Italy, Portugal, and Spain), two Canadian cities (metropolitan areas of Montreal and Toronto), New York State, and the city of San Francisco. These surveys have been undertaken with the aim of documenting the prevalence of sleep disorders in the general population according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) and the International Classification of Sleep Disorders (ICSD-90). Data are gathered over the telephone by lay interviewers using the Sleep-EVAL expert system. This paper describes the methodology involved in the realization of these studies. Sample design and selection procedures are discussed.

Adolescent↗

PubMed1994

An objective methodology for task analysis and workload assessment in anesthesia providers.

BACKGROUND: Administering anesthesia is a complex task in which either human or equipment failure can have disastrous consequences. An improved understanding of the nature of the anesthesiologist's job could provide a more rational basis for improvements in provider training as well as the design of anesthesia equipment. The objective of this study was to develop a set of techniques to evaluate anesthesiologist performance and to determine what information could be obtained from performing real-time task assessment and workload analysis tests in the operating room. METHODS: The methodology used included time-motion analysis, secondary task probing, and subjective workload assessment. The time-motion data was subjected to subsequent analysis to generate quantitative measures such as task duration (time spent focused on an individual task) and task density (the number of tasks initiated per minute). The latency of response to a "vigilance light" was used as a secondary task probe. Finally, both the observer and the subjects themselves scored workload at 10-15-min intervals throughout the case. Two groups of anesthesia providers performing general endotracheal anesthesia for simple ambulatory surgical cases (1-4 h duration) were examined using this methodology. In the first group, 3rd-yr anesthesia residents and experienced certified registered nurse anesthetists (n = 11) performed cases under limited supervision by an attending anesthesiologist. In the second group, novice residents in their first 8 weeks of training (n = 11) performed similar cases under nearly constant attending supervision. RESULTS: The two groups seemed to manifest different patterns of task behavior, task density, subjective workload, and latency of response to the vigilance task. Response latency to the vigilance task increased at times of increased workload (e.g., during induction of anesthesia). The experienced (less supervised) providers spent significant amounts of time observing the monitors and the surgical field, whereas the novice subjects spent more time conversing with the supervising attending. Despite performing fewer tasks per minute (lower task densities), the novice subjects exhibited longer latencies of response to the vigilance light and increased subjective workload. Novice subjects also had longer task duration values. For example, postintubation, novices focused on their monitors for an average of twice as long as did experienced subjects (13 +/- 2 vs. 7 +/- 1 s) before moving on to another task. CONCLUSIONS: These techniques permitted an objective description of task characteristics, workload, and vigilance in anesthesia personnel under actual work conditions. This methodology could aid in understanding the factors that affect anesthesiologists' performance and may prove useful in assessing the progress of training.

Anesthesiology↗

PubMed2005

A systematic review of the methodological rigor of studies evaluating cultural competence training of health professionals.

PURPOSE: To systematically examine the methodological rigor of studies using cultural competence training as a strategy to improve minority health care quality. To the authors' knowledge, no prior studies of this type have been conducted. METHOD: As part of a systematic review, the authors appraised the methodological rigor of studies published in English from 1980 to 2003 that evaluate cultural competence training, and determined whether selected study characteristics were associated with better study quality as defined by five domains (representativeness, intervention description, bias and confounding, outcome assessment, and analytic approach). RESULTS: Among 64 eligible articles, most studies (no. = 59) were published recently (1990-2003) in education (no. = 26) and nursing (no. = 14) journals. Targeted learners were mostly nurses (no. = 32) and physicians (no. = 19). Study designs included randomized or concurrent controlled trials (no. = 10), pretest/posttest (no. = 22), posttest only (no. = 27), and qualitative evaluation (no. = 5). Curricular content, teaching strategies, and evaluation methods varied. Most studies reported provider outcomes. Twenty-one articles adequately described provider representativeness, 21 completely described curricular interventions, eight had adequate comparison groups, 27 used objective evaluations, three blinded outcome assessors, 14 reported the number or reason for noninclusion of data, and 15 reported magnitude differences and variability indexes. Studies targeted at physicians more often described providers and interventions. Most trials completely described targeted providers, had adequate comparison groups, and reported objective evaluations. Study quality did not differ over time, by journal type, or by the presence or absence of reported funding. CONCLUSIONS: Lack of methodological rigor limits the evidence for the impact of cultural competence training on minority health care quality. More attention should be paid to the proper design, evaluation, and reporting of these training programs.

Cultural Diversity↗