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PubMed1982

Interpreting results of single-subject research designs.

Although single-subject research design has been discussed at some length in the recent physical therapy and occupational therapy literature, there has been little attempt to describe the procedures used for interpreting the experimental effects of such research. The purpose of this paper is to present the use of two strategies for determining whether changes have occurred as a result of experimental manipulation. The first strategy, visual analysis of graphed data, relies on visual interpretation of changes in data patterns both within and between experimental conditions. The second strategy is the use of statistical procedures such as trend estimation, the Rn statistic, and time series analysis. Finally, the issues of both clinical and statistical significance in interpreting the results of single-subject research are discussed.

Methods↗
PubMed2005

Behavioral headache research: methodologic considerations and research design alternatives.

Behavioral headache treatments have garnered solid empirical support in recent years, but there is substantial opportunity to strengthen the next generation of studies with improved methods and consistency across studies. Recently, Guidelines for Trials of Behavioral Treatments for Recurrent Headache were published to facilitate the production of high-quality research. The present article compliments the guidelines with a discussion of methodologic and research design considerations. Since there is no research design that is applicable in every situation, selecting an appropriate research design is fundamental to producing meaningful results. Investigators in behavioral headache and other areas of research consider the developmental phase of the research, the principle objectives of the project, and the sources of error or alternative interpretations in selecting a design. Phases of clinical trials typically include pilot studies, efficacy studies, and effectiveness studies. These trials may be categorized as primarily pragmatic or explanatory. The most appropriate research designs for these different phases and different objectives vary on such characteristics as sample size and assignment to condition, types of control conditions, periods or frequency of measurement, and the dimensions along which comparisons are made. A research design also must fit within constraints on available resources. There are a large number of potential research designs that can be used and considering these characteristics allows selection of appropriate research designs.

Behavior Therapy↗
PubMed2006

Revisiting case study as a nursing research design.

Case study research provides nurses with a form of inquiry that is holistic and appropriate for a variety of populations. Jeanine Gangeness and Eleanor Yurkovich discuss components of case study research, including its theoretical base, design methods, multiple data sources and analysis. The information presented is expanded on by using a planned population-based, multiple-case explanatory study.

Adolescent↗
PubMed1980

Research design: general designs.

The conceptual foundations for some of the most widely used research designs are presented, and the various design models are analyzed. Research designs should specify the stimulus and response, the time-order sequence, the sampling and allocation procedures, and the generalized method of analysis. Results of symbolization, seriation, and classification investigations cannot be generalized beyond the study units investigated. Cohort or case-control investigations prevent determination of causality. Cause can be logically proven if the design uses random assignment of study units to study groups and of study groups to stimulus conditions. Crossover designs offer no advantages over similarly constructed noncrossover designs, and introduce new sources of invalidity.

Models, Theoretical↗
PubMed2002

Four decades of music therapy behavioral research designs: a content analysis of Journal of music therapy articles.

This article updates previous content analyses of the Journal of Music Therapy (JMT) and presents information regarding the behavioral research approach to music therapy as reflected by published studies. JMT articles from 1964 through 1999 were examined to determine if the methodology included a behavioral research design (e.g., reversal, multiple baseline). Case studies not meeting the design criteria were excluded from the sample as were experimental group studies using a behavioral observation method or behavioral technique within a traditional statistical design. Experimental studies, however, in which behavioral research designs were included in treatment conditions and assigned to different groups were included. Articles meeting the behavioral research design criteria were analyzed to determine the type of design, the behavioral observation method and reliability report, the client population, and the music application. Of the 607 articles published in JMT, 96 or 15.8% included a behavioral research design. The lowest percentage occurred in the earliest volumes of JMT during the latter part of the 60s. An increase in behavioral research articles occurred during the 70s and 80s and continued throughout the 90s. Other findings include the following: (a) the most prevalent design was the reversal (ABA) with many variations; (b) the predominant observation methods were frequency counts and interval recording with an increase in observation reliability reports in the 80s and 90s; (c) studies published during the 80s and 90s included a wide variety of client populations compared to the 60s and 70s predominant applications with mental retardation and emotional disturbances; (d) the contingent application of music was highest during the 70s and 80s and virtually nonexistent during the 60s and 90s when other treatment conditions employed music as noncontingent background stimulus, an activity for structuring responses, and a cue for maintaining nonmusic responses. The increase in articles through the decades coupled with the increased diversity of populations suggests that behavioral research designs are flexible and applicable in music therapy practice today as much as they were during the initial phase during the 70s and 80s.

Humans↗
PubMed1985

Single-subject research designs for optometry.

Single-subject research designs are used extensively in the fields of education and psychology. There are many advantages of these designs over traditional group designs and they appear particularly important for applied research in optometry. An overview of the basic designs is presented. For each type of design, examples are provided that illustrate the application of this methodology to applied optometric research.

Feedback↗
PubMed1993

An application of mechanostat theory to research design: a theoretical model.

In this paper a theoretical model for research into the area of bone health is proposed. The model is based on the mechanostat theory of bone biology, originally proposed by Harold M. Frost, and is directed toward research in the area of osteoporosis. The mechanostat theory is briefly reviewed, including the concept of changes in minimum effective strain thresholds. Each of the model's five levels is then detailed, followed by discussion of their application to research design and interpretation. The proposed research model may provide a systematic approach to research design, and thereby a method to increase the current understanding of bone biology.

Biomechanical Phenomena↗
PubMed2006

Methodologies used in nursing research designed to improve patient safety.

Nursing research studies of patient safety for 2002-2005 were reviewed to determine methods used and methodological challenges within this field of research. Methods used in traditional clinical research and in health services research were often combined or adapted in innovative research designs to advance knowledge regarding nursing care and patient safety outcomes. This relatively new focus of complex research posed methodological challenges in areas such as measurement and the availability and analysis of data. The most frequent methods used included survey research, analysis of secondary data, and observational studies. This review points to the need to increase the incorporation of complex methodological training, including health services research, the analysis of secondary data and complex survey design in our doctoral programs, and to provide opportunities for researchers to gain further methodological training. Increased use of multi-site and multi-level studies is also needed.

Anthropology, Cultural↗
PubMedDate not supplied

Measuring the impact of patient counseling in the outpatient pharmacy setting: the research design of the Kaiser Permanente/USC patient consultation study.

This article describes the research method used to measure the impact of three alternative models of patient counseling in the outpatient pharmacy setting. The study was conducted in pharmacies operated by the Southern California region Kaiser Permanente Medical Care Program. Both random assignment and large-scale geographic area research designs were used. The presentation of the research design includes discussions of data collection and patient sampling methods; the measurement of patient outcomes, including measures of health care costs and utilization, patient functional status, and quality of life. Demographic data are presented for the study population, including an analysis of potential biased selection of patients electing to participate in random assignment. Data are also presented documenting potential selection bias across geographically determined treatment groups in the geographic area design arm. Finally, the article presents the analysis plan for the study and discusses study limitations.

Ambulatory Care↗
PubMed1984

Ends and means in research design.

General practice research often is a description of facts rather than a prediction of outcomes. This paper discusses the need to prepare protocols, to do pilot studies (to minimise error) and to be aware of the individuality of doctors and patients. The design or model for a project must be adapted to the question being asked: the means must suit the ends.

Family Practice↗
PubMed1978

Research designs for the study of gene-environment interactions in psychiatric disorders. Report of a Foundations Fund for Research in Psychiatry Panel.

Understanding the genetic and environmental contributions (and their interactions, which are likely to be complex) to the etiology of psychiatric disorders requires research designs incorporating many basic principles of genetics. Genetic variation is likely to contribute to psychiatric disorders and genetic heterogeneity is likely to exist for any single disorder, ie, completely different genetic variants may each be capable of increasing an individual's susceptibility to the disorder. Thus, it is important to define phenotypes that may more closely reflect each individual genetic variant rather than to rely solely on the psychiatric diagnosis. Research should be undertaken with the goal of testing specific hypotheses that can be excluded. Research designs can include studies of unrelated individuals, twins, separated relatives, nuclear families, or extended pedigrees. Not all hypotheses can be tested on one type of data, and appropriate analytic methods vary. Because genetic hypotheses cannot be tested on studies of unrelated individuals, it is important that data be collected on families instead of unrelated individual patients and/or controls. Studies should include traits that bridge the gap between the genotype and the diagnostic phenotype. Such studies should be multidisciplinary, and the best statistical-genetics methodology should be used for data analysis.

Adoption↗
PubMed1991

Epistemology and experimentation: an examination of quality factors in research design.

Forty-four research articles published in the occupational therapy literature were examined to determine the effect of design quality on study outcome. All 44 of the studies examined involved a parallel-groups comparison design. Twenty-two of the studies included random assignment of subjects to various groups, and the remaining 22 investigations used some nonrandom method to determine subject allocation. A standardized metric (i.e., effect size) was used to determine the effect of the independent variable in the 44 studies. The data analysis revealed that effect-size values were not significantly different between studies that involved random assignment and those not involving random assignment. The argument is made that such design characteristics as random assignment should be examined as moderator variables in any attempt to synthesize findings from multiple studies. Such an approach would treat the design used in a study as one of many possible variables that could influence the outcome. This approach would modify the a priori assumption that one research design is inherently superior to another regardless of the research question or context.

Humans↗
PubMed1997

Research design and methods of quantitative synthesis of medical evidence.

OBJECTIVE: To review the scientific principles, strengths, and limitations of research designs and methods of quantitative synthesis of medical evidence. DATA SOURCES: We used MEDLINE to perform a systematic search for literature using the keywords research design, epidemiology, and biometry. Journals searched included six major journals in obstetrics and gynecology and three in general medicine. These sources were supplemented with texts and reviews from the general medical literature. METHODS OF STUDY SELECTION: We reviewed the publications identified by our search and evaluated critically the relevant reports. We summarized objectives and scientific guidelines for the common research methodologies and outlined their advantages and disadvantages. TABULATION, INTEGRATION, AND RESULTS: The standard of clinical research design is the randomized controlled trial (RCT), which, if performed with sufficient methodologic rigor, is least likely to have serious biases. Cohort, case-control, and cross-sectional studies are common observational studies used in reproductive health; such observational studies are more susceptible to biases that can distort the researcher's results and conclusions. Descriptive studies such as case series and case reports are often interesting as clinical vignettes but have limited scientific merit. Methods for quantitative synthesis of medical evidence, including meta-analysis, decision analysis, and cost-effectiveness analysis are being used with increased frequency in the reproductive health literature to summarize medical evidence. CONCLUSION: Various research methods have their own inherent advantages and disadvantages. An understanding of the scientific principles of these methods will enable the clinician to evaluate medical evidence critically.

Biometry↗
PubMed1996

Traditional and alternative research designs and methods in clinical pediatric psychopharmacology.

OBJECTIVE: To review both traditional and alternative research designs and methods in pediatric psychopharmacology. METHOD: Study designs used in clinical trials in psychiatry were selected for review with the special considerations of pediatric psychopharmacological trials in mind. Where possible, a reference to a specific published trial in pediatric psychopharmacology was provided for each design. RESULTS: It appears that pediatric psychopharmacology trials require a relatively greater flexibility in design to avoid significant study biases. Alternative research designs may be preferable to the traditional approaches, particularly when the use of the latter may raise important issues of feasibility. CONCLUSIONS: Evolution of a clinical research hypothesis to a study protocol in pediatric psychopharmacology is a manageable task if one keeps in mind essential elements such as selection of study design, population, sample size, treatment duration, and efficacy assessments.

Adolescent↗
PubMed1998

Research design and statistical methods in Chinese medical journals.

CONTEXT: Study design and statistical analyses have improved in journals published in Western countries, but the type of research designs and statistical methods used in medical journals outside Western countries has not been assessed. OBJECTIVES: To determine the frequency of research designs and statistical techniques used in Chinese medical journals, types of statistical errors present, and trends over a 10-year period. DESIGN: Evaluation of all original articles published in 5 leading journals in 1985 (N = 640) and in 1995 (N = 954). MAIN OUTCOME MEASURES: Research designs and statistical methods. RESULTS: Compared with 1985, significant improvement was seen in 1995; the percentages of original articles reporting clinical trials, prospective studies, or basic science research increased from 18% to 31% (P<.001), the proportion of papers using statistical tests increased from 40% to 60% (P<.001), more sophisticated statistical methods were used, and of those articles using statistics, the proportion using appropriate methods increased from 22% to 46% (P<.001). In both years, the most commonly used statistical methods were t tests and contingency tables. The most common errors were presentation of P values without specifying the test used, use of multiple t tests instead of analysis of variance, and use of unpaired t tests when paired tests were required. CONCLUSIONS: The use of statistical methods in Chinese medical journals research is improving, and by 1995, the frequency of using statistical methods in published articles was similar to the results determined in previous studies of journals. However, the lack of or inappropriate use of statistics remains a serious problem.

China↗
PubMedDate not supplied

Testing incontinence pads using single-case research designs.

This article is predominantly concerned with the value of single-case research designs for generating nursing knowledge. The argument in favour of single-case research designs is made with reference to the testing of a range of body-worn incontinence pads in a group of cognitively impaired elderly women in two clinical settings.

Aged↗
PubMed1996

Explaining abstinence rates following treatment for alcohol abuse: a quantitative synthesis of patient, research design and treatment effects.

We examined the relationships of treatment, patient and research design characteristics to treatment outcome (i.e. abstinence rates) in a sample of 150 treatment conditions drawn from 100 alcohol treatment outcome studies published between 1980 and 1992. Treatment characteristics were related to abstinence rates: more intensive treatments had higher abstinence rates than less intensive treatments, whereas treatments with an expressed goal other than abstinence had lower abstinence rates than treatments with an abstinence goal. When the public vs. private ownership status of the treatment facility was taken into account, the presence of behavioral elements in the treatment condition also was related to higher abstinence rates. Because of inconsistent reporting in primary studies, we assessed the effects of only one patient pre-treatment characteristic; treatment conditions with a higher proportion of socially stable patients had better outcomes. Research design characteristics were also related to abstinence rates. Treatment conditions with shorter follow-ups and treatments drawn from studies that did not use criteria to exclude more impaired subjects had better outcomes. We discuss possible reasons why our findings regarding the effects of treatment intensity and the use of exclusionary criteria differ from those in previous reviews.

Adult↗