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PubMed2007

Methodologic quality of cost-effectiveness analyses of surgical procedures.

OBJECTIVE: The purpose of this study was to evaluate the methodologic quality of economic analyses of surgical procedures and to compare quality across publications. SUMMARY BACKGROUND DATA: With healthcare resources limited and technologies rapidly advancing across specialties, including surgery, there is increasing demand for evidence of cost-effectiveness. METHODS: A MEDLINE search identified English-language articles published from 1995 to 2004 that included economic analyses of surgical procedures. Two of the authors reviewed 110 studies and scored each based on compliance with 10 methodologic criteria. Data analyses used Cohen's kappa statistic, regression models, Mann-Whitney U tests, and Kruskal-Wallis tests. RESULTS: The 110 articles appeared in 79 different journals, including 57 articles in 37 surgical journals. Most journals (75%) had only 1 article eligible for inclusion. The average number of criteria met was 4.1, with 10 articles meeting all 10 methodologic standards. Compliance rates for the 5 methodologic criteria most frequently neglected ranged from 34% to 45% in nonsurgical journals and 9% to 14% in surgical journals (P < 0.001). CONCLUSIONS: While methodologic guidelines for cost-effectiveness analyses have appeared in the medical literature, studies of cost-effectiveness in surgery often do not meet these criteria. As healthcare policy seeks to incorporate information from economic evaluations, it is increasingly important that surgical journals adhere to accepted guidelines and perform quality assurance on these studies. This may be aided by wider promulgation of the methodologic criteria in surgical journals or at surgical meetings.

Adult↗

PubMed2005

Adapt or adopt: developing and transgressing the methodological boundaries of grounded theory.

AIMS: While acknowledging that there is an existing debate regarding the nature of grounded theory, the aim of this paper is to highlight a number of common and key areas/issues where adaptation/adoption of Glaserian grounded theory in nursing-related studies often occurs. These issues are: the differences between conceptual description and conceptual theory; beginning the study with a 'general wonderment' or a more defined research question; establishing the credibility of the theory; identifying a basic psycho-social process and emerging vs. forcing. BACKGROUND: Since the development and introduction of grounded theory in 1967, the number of studies, in a wide range of disciplines including nursing, that purport to be using a grounded theory method has grown enormously. While Glaser and Strauss acknowledged then that it was entirely appropriate for the methodology to evolve and develop, some of the studies that claim to be based on grounded theory methodology share little methodological similarity, and at times, bear only a passing resemblance to Glaserian grounded theory. DISCUSSION: Some methodological transgressions in papers that purport to be grounded theory studies are such that it would be inaccurate to term the resulting method grounded theory at all. Instead such studies are more accurately thought of as a form of qualitative data analysis. Such transgressions include a study that has no evidence of conceptualization; one that does not identify a basic psycho-social process; and one that moves from 'emerging' to 'forcing'. Other methodological adaptations of grounded theory, such as beginning the study with more than a general wonderment and broadening the approach to establishing the credibility of the theory, are more in keeping with Glaser and Strauss' position on the evolution of the method. In such cases, it is necessary to distinguish such methods from 'pure' Glaserian grounded theory, and it would be prudent and methodologically accurate to describe the resulting method as 'modified' grounded theory.

Concept Formation↗

PubMed1991

Legal methodology as nursing problem solving.

This article presents legal methodology as a form of nursing research. The four elements of the legal methodology are examined. The sources of legal authority are explained and the essential components of one case, Sermchief v Gonzales are presented in detail as an illustration of the legal methodology. In addition to the elements of the methodology, the methodological tools for the process are described. The computer and manual searching strategies are identified. Finally, the citation system which serves as an integral portion of the methodological process is discussed.

Humans↗

PubMed2005

Methodological pitfalls in the study of religiosity and spirituality.

The number of studies demonstrating a relationship between religiosity and spirituality and physical and psychological health have increased rapidly during the past decade. There are significant disputes in the literature regarding the methodological quality of research in this area. Despite nursing scholars' interest in this area, no thorough review of the methodological critiques is available. The purpose of this study is to review areas of methodological difficulty in the study of religiosity and spirituality by identifying contemporary methodological critiques, critically evaluating the critiques and the underlying issues, and making suggestions for methodological advancement in the field. Three main areas of methodological critique exist: construct measurement, study design, and data analysis. Research in this area should aim for conceptual clarity, deliberate design, and appropriate analysis. Considerations of these critiques are instructive for nursing research done in the area of religiosity and spirituality.

Data Interpretation, Statistical↗

PubMed2004

An increasing number of qualitative research papers in oncology and palliative care: does it mean a thorough development of the methodology of research?

BACKGROUND: In the second half of the nineties, a scientific debate about the usefulness of qualitative research in medicine began in the main medical journals as well as the amount of "qualitative" papers published on peer reviewed journals has noticeably increased during these last years. Nevertheless the label of qualitative methodology has been assigned to an heterogeneous collection of studies. Some of them show a complete awareness of the specificity of this kind of research, while others are still largely influenced by the quantitative paradigm prevailing in the medical field. The concern with the rigour and credibility of qualitative methods has lead to the development of a number of checklist for assessing qualitative research. The purposes of this review were to describe the quality of the development of qualitative research in the medical field, focusing on oncology and palliative care, and to discuss the applicability of a descriptive checklist. METHODS: A review was conducted on Medline and PsycINFO databases. On the basis of their abstract, papers found have been classified considering: publication year, kind of journal, paper type, data gathering method, sample size and declared methodological approach. A sub sample of the previous papers was than selected and their methodological characteristics were evaluated based on a descriptive checklist. RESULTS: 351 abstracts and 26 full papers were analysed. An increase over time in the number of qualitative studies is evident. While most of the papers before 1999 were published on nursing journals (43%), afterwards also medical journals were largely represented. Psychological journals increased from 7% to 12%. The 22% of studies used a sample size lower than 15 and the 15% did not specify the sample size in the abstract. The methodological approach was also often not specified and the percentage increased in the second time period (from 73% to 80%). Grounded theory was the most employed methodological approach while phenomenology shows a decrease. Interview remains the most used data gathering method in both periods, even if it shows a 10% reductions, while focus group and multiple methods application both increase to 12%. The use of the descriptive checklist on the full text of the 26 papers shows that all the items present a larger percentage of satisfaction after 1 January 1999 than it was for the paper published before 1999. There seems to be two different types of quality criteria: specific and unspecific. The first ones mainly refer to qualitative paradigm (such as the relationship with the subject of research or evidence about how subjects perceived the research) and they are often not satisfied. In contrast unspecific criteria (such as the connection to an existing body of knowledge or systematic data gathering) which are mainly shared with the quantitative paradigm are more frequently satisfied. CONCLUSIONS: In oncology and palliative care the publication of qualitative studies increased during the nineties, reaching its peak in around 2000. The use of descriptive checklists even if it was not easy to apply, allows researchers to get a deeper insight into methodological facets that a global judgement may leave out.

Bibliometrics↗

PubMed2003

A methodology and implementation for annotating digital images for context-appropriate use in an academic health care environment.

Use of digital medical images has become common over the last several years, coincident with the release of inexpensive, mega-pixel quality digital cameras and the transition to digital radiology operation by hospitals. One problem that clinicians, medical educators, and basic scientists encounter when handling images is the difficulty of using business and graphic arts commercial-off-the-shelf (COTS) software in multicontext authoring and interactive teaching environments. The authors investigated and developed software-supported methodologies to help clinicians, medical educators, and basic scientists become more efficient and effective in their digital imaging environments. The software that the authors developed provides the ability to annotate images based on a multispecialty methodology for annotation and visual knowledge representation. This annotation methodology is designed by consensus, with contributions from the authors and physicians, medical educators, and basic scientists in the Departments of Radiology, Neurobiology and Anatomy, Dermatology, and Ophthalmology at the University of Utah. The annotation methodology functions as a foundation for creating, using, reusing, and extending dynamic annotations in a context-appropriate, interactive digital environment. The annotation methodology supports the authoring process as well as output and presentation mechanisms. The annotation methodology is the foundation for a Windows implementation that allows annotated elements to be represented as structured eXtensible Markup Language and stored separate from the image(s).

Academic Medical Centers↗

PubMed2006

Methodological quality of randomized controlled trials of spinal manipulation and mobilization in tension-type headache, migraine, and cervicogenic headache.

STUDY DESIGN: Literature review of quality of clinical trials. OBJECTIVE: To determine the methodological quality of published randomized controlled trials that used spinal manipulation and/or mobilization to treat patients with tension-type headache (TTH), cervicogenic headache (CeH), and migraine (M) in the last decade. BACKGROUND: TTH, CeH, and M are the most prevalent types of headaches seen in adults. Individuals who have headaches frequently use physical therapy, manual therapy, or chiropractic care. Randomized controlled trials are considered an optimal method with which to assess the efficacy of any intervention. METHODS: Computerized literature searches were performed in MEDLINE, EMBASE, COCHRANE, AMED, MANTIS, CINHAL, and PEDro databases. Randomized controlled trials in which spinal manipulation and/or mobilization had been used for TTH, CeH, and M published in a peer-reviewed journal as full text, and with at least 1 clinically relevant outcome measure (ie, headache intensity, duration, or frequency) were reviewed. The methodological quality of the studies was assessed independently by 2 reviewers using a set of predefined criteria. RESULTS: Only 8 studies met all the inclusion criteria. One clinical trial evaluated spinal manipulation and mobilization together, and the remaining 7 assessed spinal manipulative therapy. No controlled trials analyzing exclusively the effects of spinal mobilization were found. Methodological scores ranged from 35 to 56 points out of a theoretical maximum of 100 points, indicating an overall poor methodology of the studies. Only 2 studies obtained a high-quality score (greater than 50 points). No significant differences in quality scores were found based on the type of headache investigated. Methodological quality was not associated with the year of publication (before 2000, or later) nor with the results (positive, neutral, negative) reported in the studies. The most common flaws were a small sample size, the absence of a placebo control group, lack of blinded patients, and no description of the manipulative procedure. CONCLUSIONS: There are few published randomized controlled trials analyzing the effectiveness of spinal manipulation and/or mobilization for TTH, CeH, and M in the last decade. In addition, the methodological quality of these papers is typically low. Clearly, there is a need for high-quality randomized controlled trials assessing the effectiveness of these interventions in these headache disorders.

Headache Disorders↗

PubMed1997

Developments in the application of impact assessment methodologies for pollution prevention.

Pollution prevention requires the assessment of various multimedia environmental impacts to ensure that the alternative selected most closely represents the environmental goals and priorities of the facility. While some facility's environmental policies are easy to assess (e.g., reduce TRI emissions), others require a more sophisticated assessment methodology (e.g., select the most environmentally-friendly manufacturing process). Chemical environmental impact assessment for pollution prevention can be very effective, but can only provide a scientifically defensible decision point if the methodologies, analytical tools, and data quality are consistent with the environmental goals and priorities expressed. In many assessments completed in the past, the assessment methodologies have been overly simplistic when compared to the environmental goals projected. More sophisticated chemical impact assessment methodologies have not been used in the past for a variety of reasons, including: poor study design, poor data quality, inadequate funding, inadequate computer systems and databases, and practitioner's lack of understanding. This paper will describe a broad range of assessment methodologies, the steps involved in various evaluations, various resources available to conduct pollution prevention impact assessments, and on-going methodology development.

Ecology↗

PubMed2005

Do the findings of case series studies vary significantly according to methodological characteristics?

OBJECTIVES: To review the use of case series in National Institute for Clinical Excellence (NICE) Health Technology Assessment (HTA) reports, to review systematically the methodological literature for papers relating to the validity of aspects of case series design, and to investigate characteristics and findings of case series using examples from the UK's Health Technology Assessment programme. DATA SOURCES: Electronic databases. NICE website. Reports produced as part of the UK's HTA programme. REVIEW METHODS: NICE HTAs that used information from case series studies were obtained from the NICE website and a range of quality criteria applied. Searches of electronic databases, handsearched journals and the bibliographies of papers were made in order to find studies that assessed aspects of case series design, analysis or quality in relation to study validity. Hypotheses relating to the design of case series studies were developed and empirically investigated using four case examples from existing reports produced as part of the UK's HTA programme (functional endoscopic sinus surgery for nasal polyps, spinal cord stimulation for chronic back pain, percutaneous transluminal coronary angioplasty and coronary artery bypass grafting for chronic angina). Analysis was undertaken comparing studies within each review. RESULTS: There was no consensus on which case series to include in HTAs, how to use them or how to assess their quality, despite them being used in 30% of NICE HTAs. No previous studies empirically investigating methodological characteristics of case series were found. However, it is possible that the search strategy failed to find relevant studies. Poor reporting of case series characteristics severely constrained analysis and there were insufficient data to investigate all the hypotheses. Findings were not consistent across the different topics and were subject to considerable uncertainty. All the examples in our analysis were surgical interventions, which are prone to additional confounding factors due to difficulties of standardisation compared with drug treatment. Our findings may not be generalisable outside the interventions studied. The case series reports included generally exhibited poor reporting of methodological characteristics. This constrained our analysis. The use of several methods of analysis has led to apparently discrepant results. Given the number of analysis performed, the usual level of significance (p = 0.05) should be viewed with caution. The most important limitation of this study is the small number of cases on which the findings are based. The results are therefore tentative and should be viewed with caution. CONCLUSIONS: Case series are incorporated in a significant proportion of health technology assessments. Quality criteria have been used to appraise the quality of case series and decide on their inclusion in reviews of studies using this design. In this small series of case studies drawn from HTAs carried out for the NHS HTA programme, little evidence was found to support the use of many of the factors included in quality assessment tools. Importantly, no relationship was found between study size and outcome across the four examples studied. Isolated examples of a potentially important relationship between other methodological factors and outcome were shown, such as blinding of outcome measurement, but these were not shown consistently across the small number of examples studied. This study is based on a very small sample of studies and should therefore be considered as exploratory. Further investigation of the relationship between methodological features and outcome is justified given the frequency of use of case series in health technology assessments. Further research into the methodological features of case series and their outcome is justified in a wider sample of technologies and larger sets of case series. Value of information analyses including case series could be explored. Further exploration of the differences between case series and randomised controlled trial results, preferably using registry or comprehensive case series data, would be valuable.

Academies and Institutes↗

PubMed1994

The associated targets methodology and the multi-isocenters radiosurgery treatment planning system Artemis-3D.

A new radiosurgical methodology, the "associated targets methodology" has been developed and tested by our group for the irradiation of complex cerebral arteriovenous malformations using our treatment planning system Artemis-3D. For the treatment of the arteriovenous malformations we used 15 MV photons generated by a Saturne 43 Linac, eight additional collimators (6-20 mm in diameter), the Betti fixation seat and the Talairach stereotactic frame. The successive steps of the associated targets' methodology are: -the prescription of a peripheral minimal therapeutic effective dose corresponding to the 60-70% cumulated isodose range; -the compartmentalization of the target volume into several sub-volumes, each of them having its own isocenter, collimator, irradiation space and isocenter dose weight; -the 3-dimensional computation and graphics requirements, and dose volume analysis; -the optimization evaluation criteria taking into account the dose inside and outside of the lesion. Two treatment planning software versions of Artemis-3D exist; the first one was developed for the sitting position and later for the supine treatment position, the second version is a multi-modalities imagery radiosurgical treatment planning system based on more powerful computers. Different types of stereotactic frames have been integrated. Three-dimensional visualization, stereotactic CT imaging, and angiography can be used for the sitting or supine position. We started using this methodology in 1990, and treated 44 patients during that year. For 26 single isocenter arteriovenous malformations, the obliteration rate was 22/26 (85%). In the 18 multi-isocenters irradiation cases, the overall obliteration rate was 11/18 = 61%. An example of successfully irradiated complex arteriovenous malformation is discussed to illustrate the methodology. With this three-dimensional methodology we have improved the results obtained during the first period (1986 to 1989) of our radiosurgical practice in which we used a two dimensional planification approach.

Dose-Response Relationship, Radiation↗

PubMedDate not supplied

The Delphi methodology (Part one): A useful administrative approach.

The Delphi methodology is used to determine, predict and explore group attitudes, needs and priorities. This paper, the first of a two part series on the Delphi methodology, will provide nurse administrators with the basic information necessary to participate in and conduct projects using the Delphi methodology. The methodology will be defined and issues related to design, sampling, instrumentation and methods of data analysis discussed. The role of the nurse administrator, when the Delphi methodology is used, will then be addressed. In the second paper, administrative applications of the Delphi methodology will be addressed.

Delphi Technique↗

PubMed1993

A comparative overview of treatment research methodology: adult vs. child and adolescent, psychopharmacological vs. psychosocial treatments.

This article provides a broad overview in a comparison format of some general methodological issues relevant to treatment research with children and adolescents. Two sets of comparisons are required to develop vigorous child and adolescent treatment research methodology: differences in methodology between adult and child/adolescent treatment studies, and similarities and differences between psychopharmacological and psychosocial treatment research in children and adolescents. This article discusses these issues and organizes them into tabular comparisons. Adult and child/adolescent methodologies differ in many ways, including ethics, recruitment, compliance, nature of variables and confounds, development and maturation, physiology, assessment, contextual factors, and background assumptions. Future treatment studies must increasingly assess interactions and additive or synergistic effects of pharmacological and psychosocial treatments. Integration of both treatment modalities into the same study requires knowledge of similarities and differences in their respective methodologies. This article compares and contrasts pharmacological and psychosocial research methodologies on 11 issues: diagnostic assessment, subject selection, design, controls, length of study, sample size, developmental issues, nature and frequency of contacts with subjects, compliance facilitation, outcome assessment, and data analysis and interpretation.

Adolescent↗

PubMed1989

Psychological impact of abortion: methodological and outcomes summary of empirical research between 1966 and 1988.

A systematic "roadmap" through the medical literature that empirically examines the incidence of psychological sequelae of induced abortion is presented. Because outcome incidence rates and methodological profiles vary substantially across studies, selective use of articles from this literature without an accompanying rationale for that selectivity could foster erroneous conclusions. Information compiled here can facilitate a rapid methodological critique of citations in abortion-related materials. Investigations published in English between January 1966 and April 1988 that quantitatively examined psychological sequelae using prospective, retrospective, or comparative methodologies are summarized in tables to produce a synopsis of the demographics, methodological limitations, and gross statistical features of each article. This quantitative guide is designed to facilitate appropriate use of the current literature, provide needed background to assess positions arising from the currently available data, and provide methodological focus for planning better studies in the future.

Abortion, Induced↗

PubMedDate not supplied

Health interview surveys in developing countries: a methodological review.

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

Cross-Sectional Studies↗

PubMed1997

Using a phenomenological research technique to examine student nurses' understandings of experiential teaching and learning: a critical review of methodological issues.

This paper provides a report of the usage of a phenomenological research methodology to investigate the influence on clinical practice of pre- and post-registration nurse education which makes explicit use of experiential teaching and learning approaches. The primary aim of the research was to explore the use of a phenomenological research methodology to examine the students' understanding of experiential teaching and learning. The claims made for the use of experiential teaching and learning approaches in both pre- and post-registration nurse courses and how clinical practice is influenced by the experiential learning elements of pre- and post-registration nurse education were also examined. The first stage of the enquiry involved focused non-directive interviews with members of BSc Nursing Studies and MSc Mental Health Branch programmes. Both programmes claim to make use of experiential teaching and learning. The data were analysed using a technique developed by Giorgi. Previous experiences of experiential teaching and learning were probed, student interpretations differentiated, and the relationship between course-based learning using experiential approaches and the implications for it's influence on practice were examined. The second stage of the enquiry has followed up the initial findings, exploring the students' experience of experiential approaches on their courses both in the classroom and in work-based learning situations. The findings are presented and discussed in the context of other studies from both nurse and higher education. Throughout the paper methodological concerns arising are discussed. The paper concludes with the identification of methodological problems arising from the research strategy: the implications of the power nexus created when teachers research students, and issues relating to the use of a phenomenological methodology in a longitudinal study.

Clinical Competence↗

PubMed1996

[Methodological quality of qualitative studies--potential measures].

Methodological quality of scientific research is argumentative persuasiveness of the conclusions of the research. Aspects of methodological quality are: methodological objectivity (including reliability, validity, subjectivity and intersubjectivity), generalizability, and, regarding action-oriented research, action-rationality. Values, which are only partly of a methodological nature, are: transferability, utilization-value, implementary value and participatory value. Concerning each of these norms and values a variety of measures to promote methodological quality in qualitative inquiry are discussed.

Diffusion of Innovation↗

PubMed1992

Suicide and patients with neurologic diseases. Methodologic problems.

OBJECTIVE: The suicide risk in patients with many neurologic diseases has been reported to be greater than that in the general population. Studies on the subject are, however, often encumbered with methodologic problems. We appraised these problems and, based on an evaluation, reappraised knowledge of the suicide risk in patients with specific neurologic diseases. DATA SOURCE: Using the computerized database MEDLINE, we identified all published reports with the key words suicide, attempted suicide, and neurologic diseases. STUDY SELECTION: We assessed and reviewed studies concerning the most common neurologic diseases for methodologic problems in the study design. DATA EXTRACTION: The following methodologic problems emerged during our review: (1) choice of study type, ie, autopsy study or follow-up study; (2) choice of study population; (3) choice of control groups; (4) epidemiologic/statistical methods used; and (5) validity of statistics reported. DATA SYNTHESIS: We analyzed the methodologic problems in studies of patients with multiple sclerosis, epilepsy, Huntington's chorea, spinal cord lesions, cranial trauma, brain tumors, Parkinson's disease, vascular disorders, and migraine. In most of the studies, the methods used gave rise to uncertainty about the conclusion presented. CONCLUSION: An increased suicide risk was found in patients suffering from multiple sclerosis and spinal cord lesions as well as in selected groups of patients with epilepsy. In other neurologic diseases, the suicide risk may be increased, but the results are uncertain due to the methodologic problems in the study design.

Brain Injuries↗

PubMed1999

Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature.

CONTEXT: Practice guidelines play an important role in medicine. Methodological principles have been formulated to guide their development. OBJECTIVE: To determine whether practice guidelines in peer-reviewed medical literature adhered to established methodological standards for practice guidelines. DESIGN: Structured review of guidelines published from 1985 through June 1997 identified by a MEDLINE search. MAIN OUTCOME MEASURES: Mean number of standards met based on a 25-item instrument and frequency of adherence. RESULTS: We evaluated 279 guidelines, published from 1985 through June 1997, produced by 69 different developers. Mean overall adherence to standards by each guideline was 43.1% (10.77/25). Mean (SD) adherence to methodological standards on guideline development and format was 51.1% (25.3%); on identification and summary of evidence, 33.6% (29.9%); and on the formulation of recommendations, 46% (45%). Mean adherence to standards by each guideline improved from 36.9% (9.2/25) in 1985 to 50.4% (12.6/25) in 1997 (P<.001). However, there was little improvement over time in adherence to standards on identification and summary of evidence from 34.6% prior to 1990 to 36.1 % after 1995 (P = .11). There was no difference in the mean number of standards satisfied by guidelines produced by subspecialty medical societies, general medical societies, or government agencies (P = .55). Guideline length was positively correlated with adherence to methodological standards (P = .001). CONCLUSION: Guidelines published in the peer-reviewed medical literature during the past decade do not adhere well to established methodological standards. While all areas of guideline development need improvement, greatest improvement is needed in the identification, evaluation, and synthesis of the scientific evidence.

Peer Review, Research↗