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Issues in methodological research: perspectives from researchers and commissioners.

OBJECTIVES: (1) Methodological research has few well-defined tools and processes analogous to those available for reviews and data collection in substantive health technology assessment. (2) This project was set up to obtain researchers' and others' views on the innovative projects on research methodology under the NHS Health Technology Assessment Programme and the usefulness of the research. (3) The study was intended to span both epistemological and management issues. (4) The following issues were explored: (a) the degree to which researchers would feel constrained by the "Cochrane" approach to systematic reviews when undertaking reviews of a methodological nature; (b) whether methodological projects may require exceptional design and management arrangements, in view of their novelty, subjectivity and complexity; (c) whether researchers would seek out other methods, in addition to undertaking reviews of argument, as a means of extending their understanding of methodological issues (there may be three categories of research methods in methodology: reviews of methodological argument, studies that use the literature as a source of data, and research that collects new primary data); (d) whether the Methodology Programme overall can be considered a "success". METHODS: (1) Telephone interviews were carried out on researchers (one senior and one junior per project), resulting in 35 interviews from 19 of the 20 target projects. (2) A qualitative postal survey was sent to 12 people who had played a key role in the development of the Methodology Programme; replies were received from six of them. (3) Analysis was undertaken of the hit rates for 29 projects on the NCCHTA website by the end of February and the end of May 1999, comparing those concerned with methodology (n = 10) and those concerned with other issues (n = 19). RESULTS: UNDERTAKING METHODOLOGICAL RESEARCH: VIEWS OF RESEARCHERS: This section summarises the views of 35 researchers who were interviewed by telephone. RESULTS: UNDERTAKING METHODOLOGICAL RESEARCH: VIEWS OF RESEARCHERS: (THE NATURE OF METHODOLOGICAL REVIEWS): (1) There was a reluctance among researchers to use the term "systematic review" in the methodological context. (2) Practical problems in undertaking methodological reviews were found at every stage of the research process. (a) In the initial search stage, preplanned strategies were difficult to maintain, owing to the need to respond to the problems of too few or too many references. (b) At the analysis stage, most studies were not formally weighted, but there was implicit weighting in researchers' views of their merits or relevance. (c) It was often only at the synthesis stage that researchers could see clearly what their study was able to do; iteration was frequently necessary at this point. (d) It was difficult to form simple conclusions and recommendations beyond summaries of what was known in the field. (e) Dissemination activities were most often directed to other health service researchers, with some attention to NHS policy makers and research commissioners. RESULTS: UNDERTAKING METHODOLOGICAL RESEARCH: VIEWS OF RESEARCHERS (THE NEED FOR FLEXIBILITY): (1) Few researchers had amended their topic or methods once their research was under way, although some had made minor changes to their original plan, generally to refine the topic to fit the time or data available. (2) Changing a topic was seen as inappropriate unless checked with funders, but changes in research methods were viewed as reasonable because questions might be refined in the light of information gained or early thinking. RESULTS: UNDERTAKING METHODOLOGICAL RESEARCH: VIEWS OF RESEARCHERS (THE QUESTION OF BIAS): (1) Few researchers considered that this kind of research could be undertaken or presented in a wholly unbiased way because of the need to assess the research studied. (2) Objectivity was nonetheless seen as something that researchers should strive towards. Efforts to do so included presenting data clearly, separating findings from discussion, covering all points of view, setting out their own assumptions and values, and testing their ideas on others known to have differing views. (3) The formal peer-review process was not seen to have made a difference here, primarily because of the stage at which referees become involved. RESULTS: UNDERTAKING METHODOLOGICAL RESEARCH: VIEWS OF RESEARCHERS (PROJECT MANAGEMENT--TIMING AND TIME MANAGEMENT): (1) A majority of projects were completed within 3 months of their due date. Those studies completed roughly on time were considered to have efficient junior researchers and good project management, including clear deadlines for different stages of the research. (2) Some studies had severe problems of time management. Too much time tended to be spent on collecting and reading the literature and the writing stage was not always well planned. Referees' comments were also slow in coming. (ABSTRACT TRUNCATED)

Attitude↗

Reasons for the loss of sensitivity and specificity of methodologic MeSH terms and textwords in MEDLINE.

OBJECTIVE: To determine the reasons for the loss of sensitivity and specificity of methodologic MeSH terms and textwords in MEDLINE for identifying sound clinical studies of the etiology, prognosis, diagnosis, prevention, or treatment of disorders in adult general medicine. DESIGN: Analytic survey of the information retrieval properties of methodologic MeSH terms and textwords selected to detect studies meeting basic methodologic criteria for direct clinical use in general adult medicine. MEASURES: Frequency of non-use and misuse of relevant methodologic MeSH terms and textwords among studies meeting and not meeting the basic criteria for clinical practice as determined by the manual review (the gold standard) of all articles in 10 internal and general medicine journals for 1986 and 1991. RESULTS: Loss of sensitivity due to the non-use of relevant methodologic terms among articles meeting basic methodologic criteria was more pronounced in the areas of diagnosis, prognosis, and etiology than treatment in 1991 and 1986. The use of relevant methodologic terms has improved from 1986 to 1991 in all areas except prognosis. Loss of specificity due to the use of relevant methodologic terms among articles not meeting basic methodologic criteria occurred most frequently in the areas of treatment and etiology. CONCLUSIONS: Although the appropriate use of methodologic MeSH and textwords has improved from 1986 to 1991 among studies meeting basic methodologic criteria for direct clinical use in general adult medicine much improvement is still needed in the areas of diagnosis, prognosis, and etiology. Improvement is needed in assigning the relevant methodologic index terms to studies that meet the methods criteria and in having the authors use the relevant methodologic textwords in the title or abstract. Some improvement is also needed in not using methodologic terms when the study clearly does not meet the methods criteria.

Abstracting and Indexing↗

A comparison of segmental and wrist-to-ankle methodologies of bioimpedance analysis.

The common approach of bioelectrical impedance analysis to estimate body water uses a wrist-to-ankle methodology which, although not indicated by theory, has the advantage of ease of application particularly for clinical studies involving patients with debilitating diseases. A number of authors have suggested the use of a segmental protocol in which the impedances of the trunk and limbs are measured separately to provide a methodology more in keeping with basic theory. The segmental protocol has not, however, been generally adopted, partly because of the increased complexity involved in its application, and partly because studies comparing the two methodologies have not clearly demonstrated a significant improvement from the segmental methodology. We have conducted a small pilot study involving ten subjects to investigate the efficacy of the two methodologies in a group of normal subjects. The study did not require the independent measure of body water, by for example isotope dilution, as the subjects were maintained in a state of constant hydration with only the distribution between limbs and trunk changing as a result of change in posture. The results demonstrate a significant difference between the two methodologies in predicting the expected constancy of body water in this study, with the segmental methodology indicating a mean percentage change in extracellular water of -2.2%, which was not significantly different from the expected null result, whereas the wrist-to-ankle methodology indicated a mean percentage change in extracellular water of -6.6%. This is significantly different from the null result, and from the value obtained from the segmental methodology (p = 0.006). Similar results were obtained using estimates of total body water from the two methodologies.

Ankle↗

'Best research practice': in pursuit of methodological rigour.

RATIONALE: This paper is based on the rationale that misuse of methodological notions in research publications lays research studies open to criticism and dismissal. AIM: In search of 'best research practice', this paper aims to examine the different qualities of four major qualitative methodologies: ethnography, descriptive phenomenology, interpretative phenomenology/hermeneutics and critical social theory. DESIGN: The study presents a critical overview of methodological decision-making, illustrating the sorts of issues researchers must consider in order to justify to the readership and to themselves the employment of a particular methodology. This is presented alongside a general overview of qualitative research and a précis of each of the major qualitative methodologies. The paper describes the methodologies, salient features, and examines methodological similarities and differences. The paper concludes by examining the need for methodological rigour within the framework of the National Health Service (NHS) Executive's drive for evidence-based practice in health care. RECOMMENDATIONS: It is hoped that the paper will stimulate a deeper exploration of methodological rigour in future research publications.

Benchmarking↗

The effect of dedicated methodology and statistical review on published manuscript quality.

STUDY OBJECTIVE: We examine how dedicated methodology and statistical review affects the quality of manuscripts published in Annals of Emergency Medicine. DESIGN: The dedicated reviewers developed a manuscript scoring form based on previously used instruments. The form contained 84 unique elements. Eight items sought the presence of state-of-the-art features (eg, formal exploration of the sensitivity of results to assumptions); the others sought substandard quality. Two raters independently scored each original research publication appearing in 4 consecutive issues of Annals for the presence or absence of each relevant item. We then reviewed the formal methodology and statistical review and all subsequent correspondence between authors and editors to determine whether the methodology and statistical review provided guidance regarding each of the 84 items and whether the advice was incorporated into the final manuscript. RESULTS: There were 32 original research articles. One was never subjected to methodology and statistical review. Reviewers agreed on 94% of all items; single-item agreement ranged from 77% to 100%. State-of-the-art features were present in 31 (14%) of 217 ratings; the methodology and statistical review had commented on 13 (42%) of these. State-of-the-art features were absent in 186 (86%) ratings; the methodology and statistical review had commented on 33 (18%) of these. Substandard features were deemed present in 166 (12%) of 1,519 ratings; the methodology and statistical review had commented on 82 (44%) of these. Substandard features were absent in 1,333 (88%) ratings; the methodology and statistical review had commented on 132 (10%) of these. We found no fatal flaws in the published manuscripts. CONCLUSION: Methodology reviewers often failed to comment on deficiencies that they had classified as substandard when designing this study. Reviews also did not encourage inclusion of state-of-the-art abstract, article, and references features. When reviews identified areas in need of improvement, only half of the comments led to improved manuscripts. In the other half, authors either rebuked the suggestions or the editors did not act when suggestions were ignored.

Peer Review, Research↗

What is the methodologic quality of human therapy studies in ISI surgical publications?

OBJECTIVE: To determine the methodologic quality of therapy articles about humans published in ISI surgical journals, and to explore the association between methodologic quality, origin, and subject matter. SUMMARY BACKGROUND DATA: It is supposed that ISI journals contain the best methodologic articles. METHODS: This is a bibliometric study. All journals listed in the 2002 ISI under the subject heading of "Surgery" were included. A simple randomized sampling was conducted for selected journals (Annals of Surgery, The American Surgeon, Archives of Surgery, British Journal of Surgery, European Journal of Surgery, Journal of the American College of Surgeons, Surgery, and World Journal of Surgery). Published articles related to therapy on humans of the selected journals were reviewed and analyzed. All kinds of clinical designs were considered, excluding editorials, review articles, letters to the editor, and experimental studies. The variables considered were: place of origin, design, and the methodologic quality of articles, which was determined by applying a valid and reliable scale. The review was performed interchangeably and independently by 2 research teams. Descriptive and analytical statistics were used. Statistical significance was defined as P values less than 1%. RESULTS: A total of 653 articles were studied. Studies came predominantly from the United States and Europe (43.6% and 36.8%, respectively). The subject areas most frequently found were digestive and hepatobiliopancreatic surgery (29.1% and 24.5%, respectively). Average and median methodologic quality scores of the entire series were 11.6 +/- 4.9 points and 11 points, respectively. The association between methodologic quality and journals was determined. Also, the association between methodologic quality and origin was observed, but no association with subject area was verified. CONCLUSIONS: The methodologic quality of therapy articles published in the journals analyzed is low; however, statistical significance was determined between them. Association was observed between methodologic quality and origin, but not with subject matter.

Bibliometrics↗

Studies of factors in relapse to alcohol, drug and nicotine use: a critical review of methodologies and findings.

OBJECTIVE: To critically review the methodologies used to study relapse in substance abusers and compare some of the findings these methodologies have produced. METHOD: Representative studies that have used retrospective, prospective, or near real time methodologies to study antecedents or consequences of relapse are presented and the strengths and weaknesses of each methodology are reviewed. Limitations in the ability of substance abusers to accurately report internal states are considered. Degree of convergence in findings across methodologies is examined. RESULTS: Retrospective reports can provide perhaps the most detailed accounts of circumstances and experiences leading up to relapse, but are also more likely to be inaccurate due to the limitations of memory. Prospective studies are less likely to be affected by memory problems, but may not capture factors that immediately precede relapse. The near real time methodology, which uses palm-top computers to gather data, has many advantages over other methodologies, but a number of limitations as well. The two studies in which retrospective reports were directly compared to either prospective or near real time reports yielded mixed results regarding degree of agreement. Findings from several areas of research suggest that some substance abusers may have difficulty recognizing and reporting internal states. CONCLUSIONS: Despite memory problems and other limitations of self-report, all three methodologies have produced findings that implicate negative affect states, increased craving, cognitive factors, interpersonal problems, and lack of coping as factors in relapse. Future relapse studies should make use of all three methodologies to obtain data on relapse and consequences, and steps should be taken to enhance the accuracy of the self-reports that are gathered with each method.

Alcoholism↗

Quality of reporting of randomized trials as a measure of methodologic quality.

CONTEXT: The evaluation of the methodologic quality of randomized controlled trials (RCTs) is central to evidence-based health care. Important methodologic detail may, however, be omitted from published reports, and the quality of reporting is therefore often used as a proxy measure for methodologic quality. We examined the relationship between reporting quality and methodologic quality of published RCTs. METHODS: Study of 60 reports of placebo-controlled trials published in English-language journals from 1985 to 1997. Reporting quality was measured using a 25-item scale based on the 1996 issue of the Consolidated Standards of Reporting Trials (CONSORT). Concealment of allocation, appropriate blinding, and analysis according to the intention-to-treat principle were indicators of methodologic quality. Methodologic quality was compared between groups of trials defined by reporting quality scores of low, intermediate, and high. Reporting quality scores were compared between groups defined by high and low methodologic quality. RESULTS: Among 23 trials of low reporting quality (median score, 9 [range, 3.5-10.5]), allocation concealment was unclear for all but 1 trial, but there were 16 trials (70%) with adequate blinding and 9 trials (39%) that had been analyzed according to the intention-to-treat principle. Among 18 trials of high reporting quality (median score, 18 [range 16.5-22.0]), there were 8 trials (44%) with adequate allocation concealment, 16 trials (89%) with adequate blinding, and 13 trials (72%) analyzed according to the intention-to-treat principle. The median reporting score was 15.0 for the 33 trials that were analyzed according to intention-to-treat principle and 14.5 for the 14 trials with on-treatment analyses (P =.67). CONCLUSIONS: Similar quality of reporting may hide important differences in methodologic quality, and well-conducted trials may be reported badly. A clear distinction should be made between these 2 dimensions of the quality of RCTs.

Publishing↗

Screening radon risks: a methodology for policymakers.

This paper provides an easy-to-use screening methodology to estimate potential excess lifetime lung cancer risk resulting from indoor radon exposure. The methodology was developed under U.S. EPA Office of Policy, Planning, and Evaluation sponsorship of the agency's Integrated Environmental Management Projects (IEMP) and State/Regional Comparative Risk Projects. These projects help policymakers understand and use scientific data to develop environmental problem-solving strategies. This research presents the risk assessment methodology, discusses its basis, and identifies appropriate applications. The paper also identifies assumptions built into the methodology and qualitatively addresses methodological uncertainties, the direction in which these uncertainties could bias analyses, and their relative importance. The methodology draws from several sources, including risk assessment formulations developed by the U.S. EPA's Office of Radiation Programs, the EPA's Integrated Environmental Management Project (Denver), the International Commission on Radiological Protection, and the National Institute for Occupational Safety and Health. When constructed as a spreadsheet program, the methodology easily facilitates analyses and sensitivity studies (the paper includes several sensitivity study options). The methodology will be most helpful to those who need to make decisions concerning radon testing, public education, and exposure prevention and mitigation programs.

Female↗

Adherence of published diabetes mellitus practice guidelines to methodologic standards of guideline development.

There are multiple practice guidelines published pertaining to diabetes care. Experts have formulated methodologic standards of guideline formulation. To determine whether practice guidelines pertaining to diabetes and published in peer-reviewed publications and the Internet adhered to established methodologic standards of guideline development. We identified all guidelines pertaining to diabetes care published between 1980 and 2000 using a computerized search of Medline, the Practice Guidelines Clearinghouse, the Institute for Clinical Systems Improvement Web site, and a global internet search engine. We used a previously validated 25-item assessment tool to determine guideline adherence to methodologic standards in three categories: guideline development and format, identification and summary of evidence, and formulation of recommendations. We conducted a multivariable regression analysis to determine the influence of guideline author, publishing medium, year of publication, and guidelines length on adherence to methodologic standards of guideline development. We evaluated 43 guidelines: 33% published on the Internet, 66% in peer-reviewed journals; 51% published by organizations, and 49% by individual experts. Of a maximum of 25 methodologic standards, the number of standards adhered by a guideline was 9 (range, 2 to 19). Mean proportion (SD) of guidelines that adhered to methodologic standards on guideline development and format was 48% (28); on identification and summary of evidence, 21% (22); and on the formulation of recommendations, 36% (27). Longer guidelines had greater adherence to methodologic standards (P < 0.0001). Guidelines pertaining to diabetes care published on the internet and in peer-reviewed publications do not meet most methodologic standards of guideline development.

Diabetes Mellitus↗

Comparison of the ESTRO formalism for monitor unit calculation with a Clarkson based algorithm of a treatment planning system and a traditional "full-scatter" methodology.

The ESTRO formalism for monitor unit (MU) calculations was evaluated and implemented to replace a previous methodology based on dosimetric data measured in a full-scatter phantom. This traditional method relies on data normalised at the depth of dose maximum (Zm), as well as on the utilisation of the BJR 25 table for the conversion of rectangular fields into equivalent square fields. The treatment planning system (TPS) was subsequently updated to reflect the new beam data normalised at a depth ZR of 10 cm. Comparisons were then carried out between the ESTRO formalism, the Clarkson-based dose calculation algorithm on the TPS (with beam data normalised at Zm and ZR), and the traditional "full-scatter" methodology. All methodologies, except for the "full-scatter" methodology, separated head-scatter from phantom-scatter effects and none of the methodologies; except for the ESTRO formalism, utilised wedge depth dose information for calculations. The accuracy of MU calculations was verified against measurements in a homogeneous phantom for square and rectangular open and wedged fields, as well as blocked open and wedged fields, at 5, 10, and 20 cm depths, under fixed SSD and isocentric geometries for 6 and 10 MV. Overall, the ESTRO Formalism showed the most accurate performance, with the root mean square (RMS) error with respect to measurements remaining below 1% even for the most complex beam set-ups investigated. The RMS error for the TPS deteriorated with the introduction of a wedge, with a worse RMS error for the beam data normalised at Zm (4% at 6 MV and 1.6% at 10 MV) than at ZR (1.-9% at 6 MV and 1.1% at 10 MV). The further addition of blocking had only a marginal impact on the accuracy of this methodology. The "full-scatter" methodology showed a loss in accuracy for calculations involving either wedges or blocking, and performed worst for blocked wedged fields (RMS errors of 7.1% at 6 MV and 5% at 10 MV). The origins of these discrepancies were quantified and the shortcomings of these MU calculation methodologies are discussed in the paper.

Algorithms↗

Q-methodology: definition and application in health care informatics.

OBJECTIVE: To introduce the Q-methodology research technique to the field of health informatics. Q-methodology--the systematic study of subjectivity--was used to identify and categorize the opinions of primary care physicians and medical students that contributed to our understanding of their reasons for acceptance of and/or resistance to adapting information technologies in the health care workplace. DESIGN: Thirty-four physicians and 25 medical students from the Chicago area were surveyed and asked to rank-order 30 opinion statements about information technologies within the health care workplace. The Q-methodology research technique was employed to structure an opinion typology from their rank-ordered statements. (The rank-ordered sorts were subjected to correlation and by-person factor analysis to obtain groupings of participants who sorted the opinion statements into similar arrangements.) RESULTS: The typology for this study revealed groupings of similar opinion-types associated with the likelihood of physicians and medical students to adapt information technology into their health care workplace. A typology of six opinions was identified in the following groups: (1) Full-Range Adopters; (2) Skills-Concerned Adopters; (3) Technology-Critical Adopters; (4) Independently-Minded and Concerned; (5) Inexperienced and Worried; and (6) Business-Minded and Adaptive. It is imperative to understand that in the application of Q-methodology, the domain is subjectivity and research is performed on small samples. The methodology is a combination of qualitative and quantitative research techniques that reveals dimensions of subjective phenomena from a perspective intrinsic to the individual to determine what is statistically different about the dimensions and to identify characteristics of individuals who share common viewpoints. Low response rates do not bias Q-methodology because the primary purpose is to identify a typology, not to test the typology's proportional distribution within the larger population. CONCLUSION: Q-methodology can allow for the simultaneous study of objective and subjective issues to determine an individual's opinion and forecast their likeliness to adapt information technologies in the health care workplace. This study suggests that an organization's system implementers could employ Q-methodology to individualize and customize their approach to understanding the personality complexities of physicians in their organization and their willingness to adapt and utilize information technologies within the workplace.

Attitude of Health Personnel↗

Methodological quality and reporting of ethical requirements in phase III cancer trials.

BACKGROUND: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. METHOD: Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231). RESULTS: The mean Jadad score was 9.86 +/- 1.117. The methodological quality was poor in 75 RCTs (Jadad score <9). The mean Berdeu score was 0.42 +/- 0.133. The mean ethical quality score for poor methodological quality RCTs (n = 75) was 0.39 +/- 0.133; it was 0.43 +/- 0.133 for good (n = 156) methodological quality RCTs (p = 0.07). There was improvement in ethical quality according to the year of commencement of the trials (p < 0.001). There was no correlation between methodological quality and the number of participating patients (R2 = 0.003, p = 0.78), between ethical quality and the number of participating patients (R2 = 0.003, p = 0.76 ), or between ethical quality and methodological quality (R2 = 0.012, p = 0.1). ICP and REC approval were not obtained for 21 and 77 trials respectively. CONCLUSION: The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed.

Clinical Trials, Phase III as Topic↗

Eight-dimensional methodology for innovative thinking about the case and ethics of the Mount Graham, Large Binocular Telescope project.

This paper introduces the Eight Dimensional Methodology for Innovative Thinking (the Eight Dimensional Methodology), for innovative problem solving, as a unified approach to case analysis that builds on comprehensive problem solving knowledge from industry, business, marketing, math, science, engineering, technology, arts, and daily life. It is designed to stimulate innovation by quickly generating unique "out of the box" unexpected and high quality solutions. It gives new insights and thinking strategies to solve everyday problems faced in the workplace, by helping decision makers to see otherwise obscure alternatives and solutions. Daniel Raviv, the engineer who developed the Eight Dimensional Methodology, and paper co-author, technology ethicist Rosalyn Berne, suggest that this tool can be especially useful in identifying solutions and alternatives for particular problems of engineering, and for the ethical challenges which arise with them. First, the Eight Dimensional Methodology helps to elucidate how what may appear to be a basic engineering problem also has ethical dimensions. In addition, it offers to the engineer a methodology for penetrating and seeing new dimensions of those problems. To demonstrate the effectiveness of the Eight Dimensional Methodology as an analytical tool for thinking about ethical challenges to engineering, the paper presents the case of the construction of the Large Binocular Telescope (LBT) on Mount Graham in Arizona. Analysis of the case offers to decision makers the use of the Eight Dimensional Methodology in considering alternative solutions for how they can proceed in their goals of exploring space. It then follows that same process through the second stage of exploring the ethics of each of those different solutions. The LBT project pools resources from an international partnership of universities and research institutes for the construction and maintenance of a highly sophisticated, powerful new telescope. It will soon mark the erection of the world's largest and most powerful optical telescope, designed to see fine detail otherwise visible only from space. It also represents a controversial engineering project that is being undertaken on land considered to be sacred by the local, native Apache people. As presented, the case features the University of Virginia, and its challenges in consideration of whether and how to join the LBT project consortium.

Arizona↗

Cost-effectiveness analyses in gynecologic oncology: methodological quality and trends.

OBJECTIVES: To evaluate methodological quality and trends of cost-effectiveness analyses (CEA) published in gynecologic oncology. METHODS: A medical literature search of articles from 1966 through 2002 was performed to identify original, English-language articles that included economic analyses in gynecologic oncology. We included articles that were cost-effectiveness or cost-benefit analyses or performed these analyses as part of their study. Ten methodological principles that should be incorporated in CEAs were assessed for each study. Each article was given a score of 0, 1, or 2 for each of the 10 methodological principles (max score = 20). Data were analyzed using the Student t test, ANOVA, and linear regression. RESULTS: We screened 693 articles to identify 68 that met our inclusion criteria. The articles focused on cervical cancer (n = 53; 78%), ovarian cancer (n = 11; 16%), uterine cancer (n = 2; 3%), and general perioperative care (n = 2; 3%). The mean (+/-SD) methodological principle score was 16.1 (+/-4.1) and we observed a significant improvement in the total score over time (P = 0.01). Primary CEA's (CEA identified as the objective of the study) were of higher quality than secondary CEA's (primary objective of the study was not CEA but CEA was included in the study; total scores 18.2 vs. 11.6, respectively; P<0.0001). Studies with at least one investigator in public health or healthcare economies also had higher quality (mean total score 17.7 vs. 15.2; P=0.006). The most common limitations of published CEAs were in methodology or presentation of incremental analyses, sensitivity analyses, and discounting. CONCLUSIONS: Cost-effectiveness analyses in gynecologic oncology showed significant improvement in quality over the last two decades. Despite this progress, methodological improvement is still needed in the areas of incremental comparisons and sensitivity analysis. Understanding the methodology of cost-effectiveness analysis is critical for researchers, editors, and readers to accurately interpret results of the growing body of CEA articles.

Analysis of Variance↗