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Methodological issues facing studies of atherosclerotic change.

BACKGROUND: The association between coronary heart disease and lesions of the coronary arteries has led to investigations of different interventions on atherosclerotic change. Currently, B-mode ultrasound of the peripheral arterial vessels, rather than arteriography of the coronary arteries, provides the most accurate evaluation of atherosclerotic disease extent in the patient. METHODS AND RESULTS: When measuring the effect of risk factor modification on atherosclerotic change, it is important to select appropriate methods and end points for quantifying disease and evaluating subsequent change. Measurements must be valid, precise, and reliable and require appropriate a priori definitions of end points and their change. Consistent methodology within studies is crucial. Multiple measurements and data reduction methods can increase the efficiency of comparisons and merit careful consideration. Missing data arising from nonvisualization of sites complicate analyses. Identifying both covariates of atherosclerotic change and possible confounding interventions require monitoring biochemical, physiological, and/or clinical variables and making inferences from these. CONCLUSIONS: To strengthen the rationale for use of B-mode ultrasonography in assessing the natural history of atherosclerosis, four methodological issues must be addressed: evaluation of primary end points using composite and/or individual measurements of atherosclerotic assessment from the carotid arteries, evaluation of new methodology that may allow assessment of the anatomy of specific lesions and/or their potential for rupture, development of methods making complementary use of both angiographic measurements of lumen diameter and ultrasound assessment of the arterial wall, and concrete demonstration of a direct link between increasing intimal-medial thickness and subsequent clinical events. The use of a continuous variable (intimal-medial thickness) in ultrasound studies offers cost/benefit advantages; this methodology continues to evolve.

Arteriosclerosis↗

Evaluating intensive family preservation programs: a methodological review.

OBJECTIVES: To determine the adequacy of evaluations of family preservation services (FPS), which are designed to support families and prevent out-of-home placements of children at risk of abuse or neglect, and to assess the effectiveness of FPS at reducing out-of-home placements of children. DATA SOURCES: References published from 1977 to 1993 were identified from a computerized search of databases for English-language publications using the key phrases "family preservation," "child abuse," and "family-based services." Unpublished references were identified by mail or phone from a listing of more than 200 programs in a national directory. SELECTION OF STUDIES: Of 802 references initially identified, 46 program evaluations were reviewed. Ten studies met the following inclusion criteria: (1) evaluated an intensive family preservation program, (2) included outcome data in the report, and (3) used a comparison group. Five were randomized trials, and 5 were quasi-experimental studies (nonrandomized). DATA EXTRACTION: Descriptive information about the programs and evaluations was collected. To determine methodological quality, two independent raters used a 15-item questionnaire to examine the assignment of families to treatment groups, the interventions provided, and the outcomes assessed. A composite score of 11 or greater represented an acceptable study, 6 to 10 represented an adequate study, and 5 or less represented an unacceptable study. RESULTS: Only two studies were rated acceptable, four were adequate, and four were unacceptable. Methodological shortcomings included poorly defined assessment of risk, inadequate descriptions of the interventions provided, and nonblinded determination of the outcomes. Rates of out-of-home placements were 21% to 59% among families who received FPS and 20% to 50% among comparison families. The relative risk of placement was significantly reduced by FPS in only two studies (one randomized trial and one quasi-experimental study). CONCLUSIONS: Despite current widespread use of FPS to prevent out-of-home placements of children, evaluations of FPS are methodologically difficult and show no benefit in reducing rates of out-of-home placements of children at risk of abuse or neglect in 8 of 10 studies. Consistent, methodologically rigorous evaluations are needed to determine the effectiveness of FPS and to guide social policy for high-risk children and their families.

Adolescent↗

[Analysis of methodological structure of research proposals submitted to the Health Care Research Fund].

BACKGROUND: Currently the methodological features of the applied-research grant proposals submitted to the Research Agencies are not well known while they play an important role in the evaluation process. The objectives of this work were to describe the methodological features and appropriateness in the fulfillment of a sample of proposals submitted to the Fondo de Investigación Sanitaria (FIS). MATERIAL AND METHODS: 216 proposals submitted to the FIS in 1993 and 1994. A specific revision protocol was designed to assess the objectives of the study according with criteria drown from the scientific literature. RESULTS: Most of the proposals correctly fulfill the items relative to the research problem description and justification. The operative component of the scientific method is scarcely fulfilled in the proposal hypothesis, objectives and methods. A 30% of the proposals do not show a typical research frame. The observational design and the basic field research are the most frequent findings in their items. The study variables, subjects, information management, plan of analysis and organization are incomplete or wrong filled in more than 50% of the proposals. The accepted proposals had an score of 1.93 in the degree of appropriate fulfillment and the non accepted 1.76, p = 0.001. The item with the strongest association to the acceptation was the appropriate definition of the variables, OR = 21.6 (CI 95%: 4.90-45.7). CONCLUSIONS: The methodological structure is not appropriate in more than 50% of the proposals submitted to the FIS. The appropriateness in the fulfillment of the methodological features increase the probability of their acceptance.

Competitive Bidding↗

Methodologic recommendations for cocaine abuse clinical trials: a clinician-researcher's perspective.

This chapter reviewed the controlled tricyclic trials for cocaine abuse with both a clinician's and a researcher's eye in order to develop methodologic recommendations for future medications development efforts. The review is summarized in table 2. The main points are that attrition is high, particularly early in the trials; placebo effects are high, particularly early and in subjective or self-report measures; and the samples may be heterogeneous with responsive (depressed, mild severity) and unresponsive (antisocial personality) subgroups. Methodologic recommendations are summarized in table 3. Emphasis is placed upon the potential heterogeneity of cocaine abusers and targeting treatments to subgroups on the one hand, and various methodologic recommendations to tighten up the design of early, small-scale pilot trials on the other. These include use of potent, standardized interventions to reduce attrition; a prolonged, single-blind placebo lead-in to wash out early dropouts and placebo effects; discarding the uncontrolled pilot trial in favor of crossover, discontinuation, or multiple-baselines designs; and considering the impressions of experienced clinicians as well as objective, urine-based measures when judging efficacy. These recommendations are all arguable in that they have disadvantages as well as advantages and that they all depart to some extent from current practice and wisdom. It is hoped that they will promote discussion and stimulate methodologic innovation in the search for effective medications for cocaine abuse.

Clinical Trials as Topic↗

[Straying in the methodology. I. Introduction].

In recent decades clinical studies with patients have gained qualitative and quantitative importance. This has led to growing interest in methodological quality. At present, doctors need more methodological knowledge. Sophisticated software enables almost everyone to carry out the most exotic of statistical and epidemiological analyses, but the methodological implications are too often incompletely understood. In a series of column-like short articles methodological items will be discussed, in order to point out frequent errors, fallacies and practical problems.

Clinical Medicine↗

[Paradigm as a methodological approach to analyzing Russia's public health system].

A concept of paradigm is applied to the analysis of the national public health system. Whether it can be used as a methodological regulator in public health management is considered. Evidence is provided for the theoretical premises of constructing a paradigm of the public health system, its philosophical bases, the notional system, methodology, and the technological framework. The theoretical and practical aspects of public health paradigm, such as identification, interpretation, and rationalization are used to analyze at the conceptual and practical level, as well as search for new ways of reforming the public health system by the paradigm approach as a deeper development of the existing paradigm or its modification. This can become a foundation for the realignments of the theoretical and practical bases of the national public health system. The formation of the new paradigm of the public health system is to take place not in a revolutionary, but in a developmental mode. Priority should be given not to radical transformations and drastic changing of the key concepts, but to the fluent increasing of new knowledge and their inclusion of the theory and practice of public health. The promises of using the paradigm methodology, allowing the internal and external principles of the operation and function of the public health system to be integrated. In this context, the paradigm approach may be used as a methodological tool for analyzing person-society-state-economy-management relations within the framework of the public health system.

Humans↗

A methodological strategy for a one-number census in the UK.

"As a result of lessons learnt from the 1991 [U.K.] census, a research programme was set up to seek improvements in census methodology. Underenumeration has been placed top of the agenda in this programme, and every effort is being made to achieve as high a coverage as possible in the 2001 census. In recognition, however, that 100% coverage will never be achieved, the one-number census (ONC) project was established to measure the degree of underenumeration in the 2001 census and, if possible, to adjust fully the outputs from the census for that undercount. A key component of this adjustment process is a census coverage survey (CCS). This paper presents an overview of the ONC project, focusing on the design and analysis methodology for the CCS. It also presents results that allow the reader to evaluate the robustness of this methodology."

Censuses↗

Why we know so little about prenatal care nationwide: an assessment of required methodology.

Policymakers, advocates, providers, recipients, and health services researchers all would agree that too little is known about the nature and effects of specific components of prenatal care. In the process of designing a national, longitudinal study of pregnancy and childbirth, we surfaced some methodological dilemmas that help to explain why so little is known. This article explores two of the major problems: (1) selecting a valid scientific sample of pregnant women and (2) collecting data from providers and women. From this analysis, seven methodological questions, which should be investigated through empirical field studies, are identified. Those field studies are essential if future research into the content of prenatal care is to achieve an acceptable level of methodological rigor.

Data Collection↗

Progress in demographic methodology.

"This paper examines developments in demographic methodology during the past decade or so. It focuses on methodological advances in the analysis of mortality of infants and young children, of adults, and on problems of mortality estimation in small populations. The other major areas reviewed here are related to the study of birth intervals, parity progression, proximate determinants of fertility, and the demography of the family. Concluding remarks relate the methodological issues to the information explosion in demography."

Adult↗

Phenomenological nursing research: methodological insights derived from Heidegger's interpretive phenomenology.

The phenomenological approach is increasingly being utilised as the method structure for nursing research studies. However, the nursing literature is beginning to reflect a concern with nurse researchers' adoption of phenomenological methods without, at the same time, laying the philosophical and methodological foundations on which the method is built. It is important for nursing knowledge development through research that the choice of research methodology can be argued for, and is judged to be coherent with, both the philosophical tone of the research and the nature of the research question. In this article the concepts underpinning Heidegger's interpretive phenomenological philosophy are examined and discussed in terms of the methodological insights they provide for the conduct of nursing phenomenological research.

Awareness↗

A study of the perceptions of hospice day care patients: my phenomenological methodology.

This paper describes the phenomenological methodology used to evaluate a hospice day care service from the perspective of twelve patients attending a UK hospice in June/July 1996. It briefly compares and contrasts a variety of phenomenological methodologies, then gives an account of the development and application of the phenomenological methodology used for the study.

Aged↗

Does breast feeding help protect against atopic disease? Biology, methodology, and a golden jubilee of controversy.

To help shed some light on the 50-year-old controversy concerning the possible protective effect of breast feeding on subsequent atopic disease, I developed 12 standards pertaining to both biologic and methodologic aspects of exposure (infant feeding), outcome (atopic conditions), and statistical analysis for studies of atopic eczema, asthma, allergic rhinitis, cow milk allergy, and other food allergy. Among the published studies on atopic eczema, the nine claiming a protective benefit of breast feeding performed less well than the 12 not making such a claim on "methodologic" standards relating to strict diagnostic criteria and blind ascertainment of outcome. The positive studies were somewhat stronger, however, on the "biologic" standards bearing on sufficient duration and exclusivity of breast feeding and on separate analysis of children at high risk. For the other atopic conditions, there were no important differences between positive and negative studies. In few negative or positive studies was there adequate control for confounding variables or examination of potential benefits relating to the severity or age at onset of atopic disease. To avoid another 50 years of unresolved controversy, future studies should improve both the biologic and methodologic aspects of their design and analysis.

Animals↗

Method and methodology in feminist research: what is the difference?

Feminism and nursing have historically travelled separate paths. Nursing has only recently begun to embrace feminist philosophy, and consequently nurse researchers are just beginning to undertake truly feminist research. There appears to be little consensus between feminist researchers' interpretations of the concepts of method and methodology. Prior to embarking on the development of a feminist research proposal it is imperative to differentiate between these two concepts. This paper explores the concepts of method and methodology and explains their interrelationship. Feminist research methodology, with its emphasis on a non-hierarchical, reflexive, interactive approach is highlighted and its impact on the researcher's choice of an appropriate method is discussed. It is only through addressing these issues that nurse researchers will be effective in pursuing truly feminist research that can act as a catalyst for the emancipation of women and the nursing profession.

Bias↗

Combining methodological approaches in research: ethnography and interpretive phenomenology.

This paper provides a detailed account of two methodological approaches commonly used in qualitative research: ethnography and interpretive phenomenology. It traces both methodologies through the various stages of a research study--data collection, analysis and validation, before considering the most appropriate methods of reconstructing the participant experience for the given audience. The author puts forward a case for the combination of methodological approaches through the triangulation of data, suggesting that this can enhance our understanding of nursing. In the case of ethnographic and phenomenological data, triangulation may enable the researcher to highlight their interpretation of the phenomenon under review, whilst at the same time considering that phenomenon in terms of the participant group, their cultural background and day-to-day experiences.

Anthropology, Cultural↗

Narrative inquiry: Locating Aboriginal epistemology in a relational methodology.

BACKGROUND: This methodology utilizes narrative analysis and the elicitation of life stories as understood through dimensions of interaction, continuity, and situation. It is congruent with Aboriginal epistemology formulated by oral narratives through representation, connection, storytelling and art. Needed for culturally competent scholarship is an experience of research whereby inquiry into epiphanies, ritual, routines, metaphors and everyday experience creates a process of reflexive thinking for multiple ways of knowing. Based on the sharing of perspectives, narrative inquiry allows for experimentation into creating new forms of knowledge by contextualizing diabetes from the experience of a researcher overlapped with experiences of participants--a reflective practice in itself. AIM: The aim of this paper is to present narrative inquiry as a relational methodology and to analyse critically its appropriateness as an innovative research approach for exploring Aboriginal people's experience living with diabetes. NURSING APPLICATION: Narrative inquiry represents an alternative culture of research for nursing science to generate understanding and explanation of Aboriginal people's 'diabetic self' stories, and to coax open a window for co-constructing a narrative about diabetes as a chronic illness. The ability to adapt a methodology for use in a cultural context, preserve the perspectives of Aboriginal peoples, maintain the holistic nature of social problems, and value co-participation in respectful ways are strengths of an inquiry partial to a responsive and embodied scholarship.

Communication↗

Work sampling: valuable methodology to define nursing practice patterns.

The volatile clinical and managerial environment of today's health care system demands that the nursing sector regularly evaluates how staff deliver care. Management's central purpose is to support clinical core activities, striving for a reasonable balance between cost effectiveness and quality care. Various methodologies, such as work sampling and time-and-motion studies, have been used to explore work-related activities. As a cost-effective and useful methodology, work sampling warrants more in-depth exploration of the various techniques involved to ensure nurse managers, clinicians and researchers appreciate the complexities of the approach and its potential to contribute to an understanding of nursing work. The present paper describes work sampling as a method, reviews its use through the literature and outlines some of its advantages and disadvantages in comparison to the time-and-motion methodology, a method similar in many ways. It is intended to enhance readers' appreciation of work sampling's potential value to nurses and other health professionals, and to enhance the understanding of the difference between work sampling and time-and-motion studies.

Nursing Methodology Research↗

The nurse researcher: an added dimension to qualitative research methodology.

Nurse researchers are increasingly adopting qualitative methodologies for research practice and theory development. These approaches to research are, in many cases, more appropriate for the field of nursing inquiry than the previously dominant techno-rational methods. However, there remains the issue of adapting methodologies developed in other academic disciplines to the nursing research context. This paper draws upon my own experience with interpretive research to raise questions about the issue of nursing research within a social science research framework. The paper argues that by integrating the characteristics of nursing practice with the characteristics of research practice, the researcher can develop a 'nursing lens', an approach to qualitative research that brings an added dimension to social science methodologies in the nursing research context. Attention is drawn to the unique nature of the nurse-patient relationship, and the ways in which this aspect of nursing practice can enhance nursing research. Examples are given from interview transcripts to support this position.

Humans↗

Ethical and methodologic benefits of using a reflexive journal in hermeneutic-phenomenologic research.

PURPOSE: To illustrate the importance of considering the researcher's written reflections on the qualitative research process as a valuable source of data and as a means of enhancing ethical and methodologic rigour. ORGANIZING CONSTRUCT: Excerpts from the researcher's reflexive journal are presented as evidence of an audit trail. Ethical and methodologic concerns arising during the research process are outlined and the value of reflecting on these issues is addressed. METHODS: A hermeneutic-phenomenologic study, conducted in Scotland, included in-depth interviews with six problem drinkers to explore the lived experience of their suffering. The researcher was considered to be a primary data-collection tool, whose reflections on the research process added to the contextual richness of the study. For an interpretative approach to data analysis, the researcher found metaphors to convey the participants' stories to a new audience. This intuitive, creative process was analysed and reported in the reflexive journal. CONCLUSIONS: The researcher's self-awareness, fostered by the use of a reflexive journal, is mirrored by the participants' ability to reflect on the final interpretation of their stories and on the therapeutic benefits of the research process. The researcher's reflexive journal reveals previously hidden contextual information which enhances the prime ethical and methodologic aim of the study--to understand the lived experience of suffering by problem drinkers.

Adaptation, Psychological↗