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PubMed2004

[Technology assessment in health care: methodological and operational questions].

Coverage policies, elaboration of clinical guidelines, and health services evaluation and management are increasingly dependent on formal technology assessments in developed countries. The objective of this study was to identify methodological and operational barriers, as well as strategies to enhance technology assessment activities, with a focus on Brazil. Methodological limitations to the elaboration of systematic reviews and economic evaluations were reviewed, including equity considerations, as well as attempts to overcome those problems; regulatory efforts in developed countries are acknowledged as a lever for methodological advances in the field. Operational barriers to the elaboration and utilization of technology assessment reports in Brazil are related to the adequacy and availability of relevant data as well as to the scarcity of trained researchers and decision-makers. Besides political barriers, constraints to the implementation of technology assessment recommendations are generally posed by methodological and transferability limitations, by communication deficits, and by factors related to the decision-making context external to the assessment itself, like availability of resources, budget flexibility, and transactional costs.

Brazil↗

PubMed1992

Field testing as clinical trial methodology in periodontics.

In the early 1950s the randomized control trial (RCT) was introduced and became widely accepted as the definitive proof of efficacy of a specific medical treatment. In fact, the acceptance and application of this methodology were instrumental in converting medicine from an unpredictable art to a science. At present no other methodologies exist that allow the evaluation of therapeutic efficacy with confidence comparable to that achieved with randomized controlled trials. In recent years researchers have applied new experimental designs and data analysis techniques to clinical trials conducted in a field trial environment to facilitate the understanding of proper use of new therapeutic agents and procedures. Since many of the new methodologies are still evolving or have only recently been introduced, this review considers some of the major trends and developments, as well as experiences of the authors, in field trial methodology. This manuscript addresses the following questions: 1) are there current clinical trial needs that are not met by RCT? 2) If so, what considerations are necessary for new approaches to have scientific usefulness? and 3) What are the strengths and weaknesses of the field trial's setting relative to an institutional environment?

Bias↗

PubMed1982

Methodological rigor and citation frequency in patient compliance literature.

An exhaustive bibliography which assesses the methodological rigor of the patient compliance literature, and citation data from the Science Citation Index (SCI) are combined to determine if methodologically rigorous papers are used with greater frequency than substandard articles by compliance investigators. There are low, but statistically significant, correlations between methodological rigor and citation indicators for 138 patient compliance papers published in SCI source journals during 1975 and 1976. The correlation is not strong enough to warrant use of citation measures as indicators of rigor on a paper-by-paper basis. The data do suggest that citation measures might be developed as crude indicators of methodological rigor. There is no evidence that randomized trials are cited more frequently than studies that employ other experimental designs.

Data Collection↗

PubMed1995

Methodological and conduct principles for pharmacoeconomic research. Pharmaceutical Research and Manufacturers of America.

In January 1995, the Pharmaceutical Research and Manufacturers of America (PhRMA) adopted a voluntary set of principles to provide guidance for its member companies on the conduct and evaluation of pharmacoeconomic research. The principles were prepared by a working group of pharmacoeconomic scientists from the PhRMA Task Force on the Economic Evaluation of Pharmaceuticals. The principles were reviewed by a panel of academic experts and outside reviewers at each stage of their development. The PhRMA document consists of a set of broad principles that will foster high quality pharmacoeconomic research without impeding further methodological development of the field. Specific recommendations are offered in those methodological areas for which general agreement exists. However, no attempt was made to force a consensus for those methodological issues which have yet to be resolved. The principles address methodology and reporting of research rather than sponsor-investigator relationships or conflict of interest issues, which have been addressed elsewhere. This approach is based on the belief that the scientific integrity of pharmacoeconomic research is best ensured through the soundness of the research methods used and the full disclosure and transparency of all methods, analyses and results.

Communication↗

PubMed1999

Costs of diabetes. A methodological analysis of the literature.

OBJECTIVE: To review studies on the costs of diabetes and its complications through a scheme designed specifically for assessing the quality of cost-of-illness (COI) studies. DESIGN AND SETTING: The methodology of COI studies in diabetes was analysed in order to assess the significance of quantitative results. The scheme adopted 7 items identified as the main points for discussing the methodological choices governing the results. We also used a checklist based on questions related to the 7 items. MAIN OUTCOME MEASURES AND RESULTS: The answers showed that many studies appear not to give technical details, so it is hard to understand the method. Methodological choices varied widely between the studies. This is probably due to the lack of consensus on the methodology of COI studies. Based on the findings of this review, we suggest also some specific points that could help produce more reliable results on the costs of diabetes. CONCLUSIONS: Clearly, a general consensus on COI studies is still remote, making the value of any comparison of results questionable.

Cost of Illness↗

PubMed2005

A methodology for the evaluation of disinfection technologies.

There are several concerns associated with the use of chlorine for potable water disinfection. These are the resistance of certain pathogens, the formation of toxic disinfection by-products and the adverse effects on aesthetic water quality. Owing to these concerns the water industry is continually reviewing alternative disinfection technologies. A methodology has been devised that will aid the water industry in evaluating the potential of these technologies. The methodology uses seven criteria to evaluate the technologies, these are: inactivation efficiency, disinfection byproduct (DBP) formation, toxicity, aesthetic water quality, cost, scalability and residual maintenance. Each criterion is assessed by associated questions in order of importance in accordance with a protocol. The criteria are evaluated using UK water quality regulations as standards. Ultraviolet (UV) disinfection was used as an example to demonstrate the methodology. UV was shown to meet all the criteria apart from the provision of a residual disinfectant. Several other disinfection technologies were evaluated using the methodology. Direct electrochemical disinfection and mixed oxidant generators were identified as having the most potential for replacing chlorination.

Disinfection↗

PubMed2006

Estimating costs and benefits of advanced control for wastewater treatment plants--the MAgIC methodology.

This paper discusses a methodology to estimate the costs and benefits of advanced control for wastewater treatment plants. The methodology has been applied to four wastewater treatment plants, representing four standard types of plants built in Flanders, Belgium. The paper outlines the methodology and illustrated results from one of the four design cases. General results are shown and contrasted with full-scale experience. The methodology appears to give realistic results and will be used for further refinement of default control algorithms for certain types of plants. A preliminary analysis indicates that on-line control can become cost-effective for plant sizes above 50,000 population equivalents.

Automation↗

PubMed1998

Setting up of an original computer-assisted methodology to characterize in vitro drug-induced anti-angiogenic effects.

The development of angiogenesis within a tumor brings on a sequence of extremely complex molecular events. We have developed a methodology which enables a wide set of biological parameters to be quantitatively determined in the field of anti-angiogenesis pharmacology. This methodology which includes a video cell tracking device, is unique because it offers the possibility of evaluating the specific influence of a given compound with potential anti-angiogenic properties on cell cycle kinetics, cell death, global cell line growth, and cell motility. We chose TNP-470, a synthetic analogue of fumagilin, to test our methodology on HUVEC cell lines taken from various human umbilical cord veins. The experiments carried out with TNP-470 did not confirm all the data reported in the literature. Our results show that i) TNP-470 could be considered as a cytotoxic agent; ii) this compound had an apparently marginal cytostatic effect; and iii) it did not increase the apoptosis level. Our methodology also revealed that the HUVEC cell lines are very heterogeneous in terms of different biological parameters. This highlights the problem of the reproductibility of the result.

Angiogenesis Inhibitors↗

PubMed1991

The search for useful methodologies in occupational science.

Debate currently exists on the soundness of various research methodologies in the social sciences. In the present paper, this question is addressed in relation to the emerging discipline of occupational science. First, the discipline of occupational science is defined. Next, two competing methodologies--Paradigm 1, Positivistic, and Paradigm 2, Naturalistic--are contrasted. The criteria of genuineness and trustworthiness are proposed as crucial for the evaluation of the soundness of available research methodologies for the extension of occupational science. Next, exemplars of research methodologies that meet these criteria are described. In the conclusion, the role that nonscientific ways of knowing, such as art and literature, may play in the understanding of human occupation is discussed.

Health Services Research↗

PubMed2004

Comparing accuracy of risk-adjustment methodologies used in economic profiling of physicians.

This paper examines the relative accuracy of risk-adjustment methodologies used to profile primary care physician practice efficiency. Claims and membership data from an independent practice association health maintenance organization (HMO) were processed through risk-adjustment software of six different profiling methodologies. The Group R2 statistic was used to measure, for simulated panels of HMO members, how closely each methodology's cost predictions matched the panel's actual costs. All but one methodology explained at least 50% of panel cost variance with panels as small as 25 patients. Group R2 performance tended to be better when high-cost cases were included rather than excluded from the analyses.

Costs and Cost Analysis↗

PubMed1999

The prevalence of low back pain in adults: a methodological review of the literature.

The prevalence of low back pain (LBP) has been reported in the literature for different populations. Methodological differences among studies and lack of methodological rigor have made it difficult to draw conclusions from these studies. A systematic review was done for adult community prevalence studies of LBP published from 1981 to 1998. The technique of capture-recapture was performed to estimate the completeness of the search strategy used. Established guidelines and a methodological scoring system were used to critically appraise the studies. Thirteen studies were deemed methodologically acceptable. Differences in the duration of LBP used in the studies appeared to affect the prevalence rates reported and explain much of the variation seen. It was estimated that the point prevalence rate in North America is 5.6%. Further studies using superior methods are needed, however, before this estimate can be used with confidence to make health care policies and decisions relating to physical therapy.

Adult↗

PubMed1999

Compliance with methodological standards when evaluating ophthalmic diagnostic tests.

PURPOSE: To draw attention to the importance of methodological standards when carrying out evaluations of ophthalmic diagnostic tests by reviewing the extent of compliance with these standards in reports of evaluations published within the ophthalmic literature. METHODS: Twenty published evaluations of ophthalmic screening/diagnostic tests or technologies were independently assessed by two reviewers for compliance with the following methodological standards: specification of the spectrum composition for populations used in the evaluation, analysis of pertinent subgroups, avoidance of work-up (verification) bias, avoidance of review bias, presentation of precision of results for test accuracy, presentation of indeterminate test results, and presentation of test reproducibility. RESULTS: Compliance ranged from just 10% (95%CI, 1%-32%) for presentation of test reproducibility data and avoidance of review bias to 70% (95%CI, 46%-88%) for avoidance of work-up bias and presentation of indeterminate test results. Only 5 of the 20 evaluations complied with four or more of the methodological standards and none with more than five of the standards. CONCLUSIONS: The evaluations of ophthalmic diagnostic tests discussed in this article show limited compliance with accepted methodological standards but are no worse than previously described for evaluations published in general medical journals. Adherence to these standards by researchers can improve the study design and reporting of evaluations of new diagnostic techniques. Limited compliance, combined with a lack of awareness of the standards among users of research evidence, may lead to the inappropriate adoption of new diagnostic technologies, with a consequent waste of health care resources.

Bias↗

PubMed1999

[Assessment of educational performance of different teaching methodologies applied to medical students in the area of arterial hypertension].

BACKGROUND: Modernization of medical teaching includes the use of new teaching methodologies and among these, computer assisted tutorials. Previous experience has shown that this type of methodology is associated with better student performances. AIM: To assess the cognitive performance of fourth year medical students using different teaching methodologies. MATERIAL AND METHODS: During the hypertension course, medical students were allowed to choose to receive a printed booklet (group A), to receive the booklet and attend lectures (group B), to receive the booklet and use a multimedial educational program (group C) and to use all three methodologies (group D). Cognitive performance was evaluated with a multiple choice test scored from 0 to 100. RESULTS: The mean scores obtained by students were 84.5 in group A, 82.4 in group B, 88.9 in group C and 84.4 in group D. This overall score of 83.6 in hypertension was significantly better than the mean score of 72.5 obtained in the cardiology test. CONCLUSIONS: Allowing students to choose the most suitable method to learn according to their personal preferences, results in a better cognitive performance.

Education, Medical↗

PubMedDate not supplied

Methodological aspects of the medical examination of special contingents in the All-Russian Service of Disaster Medicine.

The tasks required for the preservation of the health of rescuers can be accomplished with the creation of a system for medical examinations and rehabilitation that functions with commonly used methodological and organizational principles. Absence of such a common methodological platform often results in the disqualification of members of the special contingent and a mistake in the evaluation process that gives birth to serious medical and social problems. The specific character of the rescuers' activities during conditions associated with extraordinary situations necessitates the development of criteria-based evaluation systems for determining the prognosis, and the clinical, diagnostic, normative, and legal, medical, and social criteria that include methodological approaches that define the criteria to be used in the examinations. We propose that the concept of the professional health examinations becomes the methodological basis used for the medical examinations and rehabilitation of the rescuers.

Disasters↗

PubMed2000

Reliability, validity, and methodological issues in assessing physical activity in a cross-cultural setting.

In summary, to complement the issues raised in Dr. Kriska's paper, this paper identified a number of methodological issues that researchers need to address before valid cross-cultural comparisons can be performed (see summary of issues and proposed actions for researchers in Table 1). In addition, this paper cautions us to interpret published findings in light of the methodological issues that were raised in this paper. This paper selectively addressed some methodological issues and leaves ample room for other researchers to think of other important issues. Many of the issues raised in this paper are related to the use of questionnaires to make cross-cultural comparisons. However, many of the methodological issues presented in this paper apply to other methods of assessing physical activity behaviors. As a final remark, I do want to acknowledge that other methods used to measure physical activity (including activity monitor) provide valuable but different information than questionnaires. It remains that in large-scale epidemiological studies, questionnaires are often the most practical instrument to use, and given the errors associated with questionnaires, we need to consider whether questionnaires are better at measuring physical activity behaviors at the group level or individual level.

Adult↗

PubMed2000

Economic evaluation studies in nuclear medicine: a methodological review of the literature.

BACKGROUND: The growing need for evaluation of the utility of new nuclear medicine technologies has spawned a few economic studies ranging from preliminary indications of cost savings to complete decision analysis models incorporating costs and quality of life. The objective of the current study was to evaluate the methodological quality of economic analyses of nuclear medicine procedures which targeted cost-effectiveness or cost-utility issues published in the medical literature during the years 1985-1999. METHODS: A computerized literature search was used to identify original investigations from the medical literature which included an economic analysis of a nuclear medicine procedure. Each economic analysis article was evaluated by two independent reviewers for adherence to ten accepted methodological criteria. RESULTS: Of the 29 articles meeting the search criteria, only six (21%) conformed to all ten methodological criteria. CONCLUSIONS: Published economic analyses of nuclear medicine procedures usually do not meet accepted methodological standards and could be significantly improved to achieve overall better quality relative to similar analyses in the literature from other medical fields. Continued improvement in the number and quality of economic studies is critically needed for the future competitiveness of nuclear medicine studies.

Cost-Benefit Analysis↗

PubMed2001

Meta-analyses in orthopaedic surgery. A systematic review of their methodologies.

BACKGROUND: The number and quality of well-designed scientific studies in the orthopaedic literature are limited. The purpose of this review was to determine the methodological qualities of published meta-analyses on orthopaedic-surgery-related topics. METHODS: A systematic review of meta-analyses was conducted. A search of the Medline database provided lists of meta-analyses in orthopaedics published from 1969 to 1999. Extensive manual searches of major orthopaedic journals, bibliographies of major orthopaedic texts, and personal files identified additional studies. Of 601 studies identified, forty met the criteria for eligibility. Two investigators each assessed the quality of the studies under blinded conditions, and they abstracted relevant data. RESULTS: More than 50% of the meta-analyses included in this review were published after 1994. We found that 88% had methodological flaws that could limit their validity. The main deficiency was a lack of information on the methods used to retrieve and assess the validity of the primary studies. Regression analysis revealed that meta-analyses authored in affiliation with an epidemiology department and those published in nonsurgical journals were associated with higher scores for quality. Meta-analyses with lower scores for quality tended to report positive findings. The meta-analyses that focused upon fracture treatment and degenerative disease (hip, knee, or spine) had significantly lower mean quality scores than did meta-analyses that examined thrombosis prevention and diagnostic tests (p < 0.05). CONCLUSIONS: The majority of meta-analyses on orthopaedic-surgery-related topics have methodological limitations. Limitation of bias and improvement in the validity of the meta-analyses can be achieved by adherence to strict scientific methodology. However, the ultimate quality of a meta-analysis depends on the quality of the primary studies on which it is based. A meta-analysis is most persuasive when data from high-quality randomized trials are pooled.

Humans↗

PubMed1975

Planning serials cancellations and cooperative collection development in the health sciences: methodology and background information.

In an era of steady-state budgets many research and academic libraries must cancel a significant number of current serials to maintain acquisitions of monographs. Thus paper reviews several techniques that have been used or that are of potential use in a rational selection of titles for cancellation. The context of the proposed methodology involves a network of libraries rather than an individual library. The methodology was tested with specific health sciences serial titles held by University of California libraries and resource libraries in NLM Region XI. As a test for the proposed methodology, background data were collected on 600 current foreign language serial titles included in SERLINE and held by at least one of the libraries in the networks of interest. Price, major secondary service coverage with productivity/impact factors, extent of holdings, and average number of recorded circulations per year in several of the libraries were recorded for each title. With the use of several different rules, estimates were made of the subscription savings that might be realized. It seems feasible to extend the same methodology to other groups of serial titles.

Abstracting and Indexing↗