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The unannounced standardised patient methodology--a potential feedback tool for registrar training.

BACKGROUND: The external clinical teaching visits (ECTV) remain the primary method of monitoring registrar progress and provide valuable feedback. The unannounced standardised patient (USP) methodology may represent an innovative tool to assess registrar performance and provide feedback that could complement the current ECTV program. OBJECTIVE: This article provides an overview of current feedback processes in registrar training, presents a review of the literature on the USP as an innovative performance assessment tool, and proposes its potential application for general practice registrar training as an effective audit and feedback tool. CONCLUSION: The USP methodology has been thoroughly tested, validated and embraced by many countries. Recently, the USP tool has been described as the validated, gold standard methodology to discriminate among variations in the quality of clinical practice. Most studies have used the USP tool to assess actual performance of practising doctors, with minimal attention being given to its potential as a feedback/teaching tool. The use of the USP for this purpose represents an opportunity for further research.

Australia↗

[Methodological obstacles encountered in the evaluation of psychotherapies of schizophrenic patients. A general review].

Through a critical review of literature, authors suggest a methodological reflexion about problems in evaluation of effects of psychotherapies of schizophrenics, taking into account not only individual techniques but also institutional ones with psychotherapeutic orientations. Among the main difficulties are: evaluation with too much unspecific and over simplified criteria, for example criterium of rehospitalisation; lack of real comparability between groups, or techniques, and lack of validity of randomisation, still considered as a pawn of methodological rigour; diversity of levels of experience, and education of therapists, too unmatched model of functional organisation of the different centers, and in the same time too unequal recruitment of patients and at length of proposed therapeutic programs. Moreover, and even before these methodological bias, a more basic obstacle must be considered. It is the non-opening of models to the falsification, denounced by Bignami as the impossible verification of the heuristic value of the proposed models, ie the impossible verification of the utility of the proposed programs for individual therapies of schizophrenics.

Bias↗

The U.S. Environmental Protection Agency's inhalation RfD methodology: risk assessment for air toxics.

The U.S. Environmental Protection Agency (U.S. EPA) has advocated the establishment of general and scientific guidelines for the evaluation of toxicological data and their use in deriving benchmark values to protect exposed populations from adverse health effects. The Agency's reference dose (RfD) methodology for deriving benchmark values for noncancer toxicity originally addressed risk assessment of oral exposures. This paper presents a brief background on the development of the inhalation reference dose (RfDi) methodology, including concepts and issues related to addressing the dynamics of the respiratory system as the portal of entry. Different dosimetric adjustments are described that were incorporated into the methodology to account for the nature of the inhaled agent (particle or gas) and the site of the observed toxic effects (respiratory or extrarespiratory). Impacts of these adjustments on the extrapolation of toxicity data of inhaled agents for human health risk assessment and future research directions are also discussed.

Administration, Inhalation↗

Estimates of quality and reliability with the physiotherapy evidence-based database scale to assess the methodology of randomized controlled trials of pharmacological and nonpharmacological interventions.

BACKGROUND AND PURPOSE: Systematic reviews and meta-analyses often include an evaluation of the methodological quality of the individual studies that have been included, and are usually conducted by at least 2 individuals. The objective of this study was to assess the methodological quality and reliability of a series of randomized controlled trials (RCTs) of both pharmacological and nonpharmacological interventions by use of the 10-item Physiotherapy Evidence-Based Database (PEDro) Scale. METHODS: Two abstractors independently reviewed 81 RCTs assessing a variety of interventions. The Cohen kappa statistic and the intraclass correlation coefficient (ICC) were used to assess agreement between abstractors. RESULTS: The average total PEDro scores were 5.94 (SD=1.43) for all studies combined, 6.88 (SD=1.2) for pharmacological studies, and 5.29 (SD=1.26) for nonpharmacological studies. The median score for pharmacological studies was significantly higher than that for nonpharmacological studies (7 versus 5). Pair-wise kappa scores ranged from a low of .452 for concealed allocation among drug trials to perfect agreement (1.00) for randomization and reporting of results from between-group comparisons. The ICCs associated with the cumulative PEDro score were .91 (95% confidence interval [CI]=.83-.94) for all studies, .89 (95% CI=.78-.95) for pharmacological studies, and .91 (95% CI=.84-.952) for nonpharmacological studies. DISCUSSION AND CONCLUSION: The methodological quality for pharmacological interventions was significantly higher than that for nonpharmacological interventions. There was good agreement between raters at an individual item level and in total PEDro scores. A lack of reporting clarity, poor organization of the report, or the failure to include salient details contributed to less-than-perfect agreement between raters.

Drug Therapy↗

Updating Medicare's physician fees: the sustainable growth rate methodology.

Medicare's method to annually update the fees it pays physicians has been under fire for some time--specifically, since the method determined that physician fees should be reduced rather than increased. The update method, called the sustainable growth rate (SGR), was implemented to control the growth in Medicare physician spending. Yet Congress, in response to physician concerns about beneficiary access to care, has acted to avert physician fee cuts since 2003. Although this signals dissatisfaction with the SGR methodology, there is yet to be a widely accepted physician fee update proposal that balances federal budgetary realities with the need to ensure beneficiary access. And the cost of changing the update method continues to mount, adding to the difficulties of developing a solution that meets the needs of all stakeholders. This issue brief describes the SGR methodology, the reasons why projected physician fee updates are negative, and some options that have been proposed to remedy the current situation. This issue brief is the second of two related papers on physician spending and Medicare's sustainable growth rate methodology. The companion paper was published on October 9, 2006 (see Issue Brief 815, available at www.nhpf.org/pdfs_ib/IB815_PhysicianSpending_10-09-06.pdf).

Humans↗

Methodology in anti-emetic trials.

Major progress in the ability to control chemotherapy-induced emesis has been made over the past 10 years. One of the several factors contributing to this improved control has been the development of accurate assessment methodology. The application of proper study methodology fostered the identification of active single agents and led to the formation of effective anti-emetic combinations. In this communication, important areas in anti-emetic study evaluation will be outlined. Proper methodology includes selection of agents or regimens that have a good rationale for study. Patient, chemotherapy, and anti-emetic factors must be controlled or standardised in good trial design, and the evaluation techniques for determining the amount of emesis or of nausea must be performed using reliable and valid methods. The statistical design employed and number of patients entered in the trial should be determined based on achievable and relevant goals.

Adult↗

Methodological issues in conducting research on parent-infant attachment.

The study of the parent's attachment to his or her infant has recently become a research topic of great interest to parent-child nursing practitioners. The parent-infant relationship has been examined using a variety of methodological approaches. Brazelton Neonatal Behavioral Assessment Scale demonstrations, home and laboratory observations, process recordings, videotape analyses, self-reported questionnaires, and developmental screening tools have all been used by researchers to measure the quality of this earliest form of human attachment. However, there are rising concerns as to the validity of attachment research in general, as well as methodological limitations in collecting data on parent-infant interactions. This article discusses issues of methodological concern in attachment research and makes suggestions to strengthen validity.

Adult↗

Adult day health care evaluation study: methodology and implementation. Adult Day Health Care Evaluation Development Group.

The Adult Day Health Care Evaluation Study was developed in response to a congressional mandate to study the medical efficacy and cost effectiveness of the Adult Day Health Care (ADHC) effort in the Department of Veterans Affairs (VA). Four sites providing ADHC in VA facilities are participating in an ongoing randomized controlled trial. Three years of developmental work prior to the study addressed methodological issues that were problematic in previous studies. This developmental work resulted in the methodological approaches described here: (1) a patient recruitment process that actively recruits and screens all potential candidates using empirically developed admission criteria based on predictors of nursing home placement in VA; (2) the selection and development of measures of medical efficacy that assess a wide range of patient and caregiver outcomes with sufficient sensitivity to detect small but clinically important changes; and (3) methods for detailed, accurate, and efficient measurement of utilization and costs of health care within and outside VA. These approaches may be helpful to other researchers and may advance the methodological sophistication of long-term care program evaluation.

Aged↗

A methodology for near-optimal computational superimposition of two-dimensional digital facial photographs and three-dimensional cranial surface meshes.

The authors present a methodology for human identification based on digital superimposition techniques. This methodology computes a fast, near optimal fit between a three-dimensional skull surface mesh and a two-dimensional digitized facial photograph. Since this is done digitally, (1) the photograph can be enhanced to reduce or eliminate motion blur, overexposure or underexposure, and out-of-focus distortions; (2) previous problems with skull/photograph scaling and alignment are minimized or eliminated; and (3) the photograph and skull can be numerically correlated. Two of several test cases produced from an implementation of this methodology are also presented.

Forensic Medicine↗

Methodologies for clinical ethics.

Truly professional medical ethics requires a methodology that generates both moral discernment and consistently right judgments. In this article the author briefly reviews difficulties involved in ethical decision-making, the historical development of casuistry, and four ethical methodologies employed in clinical medicine today. These latter, which are outlined and compared, are as follows: the methodology developed by David Thomasma in the 1960s and 1970s; one created by Jonsen, Siegler, and Winslade; another developed by the author; and the Bochum Protocol authored by Hans-Martin Sass et al. of the Bochum Center for Medical Ethics in the Federal Republic of Germany.

Casuistry↗

Mycotoxin methodology.

The development of methods with high specificity and low limits of determination, as well as screening methods that are convenient for detection and rough quantitation of mycotoxins, has proceeded at an accelerating rate over the past few years. Of particular interest has been the widespread application of high performance liquid chromatographic and immunoassay techniques in mycotoxin methodology. An overview of the latest developments in mycotoxin methodology is presented with emphasis on the need for attention to sampling and sample preparation, the basic principles supporting the analytical methodology, the need for techniques to confirm analyte identification, and the requirement for high-quality reference materials.

Aflatoxins↗

A comparison of methodologies in detection of the anaerobic threshold.

Peak cardiopulmonary exercise performance is readily evaluated. The most appropriate methodology for assessment of submaximal exercise performance, however, is a subject of controversy. Therefore, we assessed the difference between conventional methodologies using standard criteria to estimate the onset of anaerobiosis and compared them with known gas exchange and blood lactate [( La]) concentrations. Oxygen uptake (VO2) was determined at both the gas exchange anaerobic threshold (ATge) and the lactate threshold (LaT) using the following three types of commonly used methodologies in a blinded fashion: 1) conventional techniques based on manual inspection of plots of gas exchange indexes and [La] versus time, 2) computerized linear regression analysis of two-segment model plots for VCO2 versus VO2 and log [La] versus log VO2, and 3) fixed values determining the VO2 at a respiratory exchange ratio (VCO2/VO2) of 1.00 and at an [La] of 2 mmol/l. Respiratory exchange data were collected on a breath-by-breath basis in 30 men with documented myocardial infarction. Simultaneously, arterial blood was sampled for [La] every 20 seconds during maximal exercise on an upright bicycle ergometer programmed for a continuous ramp protocol of 15 W/min. The mean (+/- SD) peak VO2 was 1,463 (+/- 312) ml/min. The mean (+/- SD) VO2 values for each method were as follows: (table; see text) These results indicate that a good positive correlation exists between the gas exchange and lactate data by all three approaches. The chosen fixed values yield the highest threshold detection for both ATge and LaT. Detection was lowest using regression analysis for LaT.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

[Education at a distance as a methodological option for the development of continuing education processes for human resources in health].

It is becoming increasingly essential to put into effect the processes of continuing education that will facilitate continuing access to education, adapt to political changes, technological advances and current situations, and reach all the population to be trained. In so doing, institutions must implement new educational methodologies that reduce costs and extend coverage. One of these methodologies is education at a distance, which is examined in this article. This type of approach uses methods and techniques for individual and team work (studies based on written and audiovisual materials which, along with back-up tutoring and practical equipment and instruments, make up an instructional package) and physical presence activities under direction and supervision; at the same time, it offers the possibility of a study schedule that complements the work day. It also facilitates the continuing education of in-service personnel and encourages to assume greater responsibility for their own instruction with a view to their own overall development and to the attainment of excellence in the performance of services. Education at a distance is an option for the training of manpower committed to the performance of health services, and it must be introduced into current educational programs slowly and by degrees. The Health Training Program for Central America and Panama (PASCAP) is preparing a methodological guide for the design of systems of education at a distance as a frame of reference that must be adapted to the specific characteristics and needs of each country and institution. These stages are, broadly, a conceptual framework and academic planning, academic production, teaching-learning, and evaluation.

Audiovisual Aids↗

[Interpretation of mechanograms of the quadriceps femoris muscle twitch from technical, methodologic and physiologic aspects].

It is proved, that the physiological interpretation of the peaks in the quadriceps femoris muscle twitch mechanogramme is possible. The measuring chain (sensor-amplifier-magnetic data recorder-plotter) has a resonance frequency of 170 Hz and is suitable for the true representation of the tension-time-course. In order to compare the tensions with one another, it is necessary to standardize the tensions on the lower leg or body mass. Considering the fact that the twitch mechanogramme is a summation of the contractions of the fast twitch fiber (FTF) and slow twitch fiber population (STF), it has been assumed that both FTF and STF show contraction peaks. Essential methodological influences on the tension-time-course result from the relationship between tension sensor and biological system (lower leg mass). The measuring chain and lower leg mass represent a feather-mass system. The provoked oscillations of the lower leg mass may produce methodological peaks in the twitch mechanogramme. In general, the mechanogramme shows contractions superimposed by mechanical processes. The tonogramme shows that the tension-time-course of the twitch is characterized by several peaks too. In the tonogramme characteristic changes depending on the portion of the quadriceps femoris muscle (rectus femoris, vastus lateralis) can be seen. Following the muscle action potential (MAP) there are frequently reflex-MAP's variable in form and amplitude in the time range between 120-180 ms after the stimulus impulse. They allow to explain the peaks in the mechanogramme with contraction times (CT) of 140-160 ms, or they provoke an extension of the relaxation times. Some reflex-MAP may have a latency of only 80 ms. The analysis of the methodological components influencing the mechanogramme of the muscle twitch shows that the interpretation as FT- or ST-peaks has to be done from the point of view of physiology. The following results indirectly speak for the interpretation as FT- or ST-peaks (CT: 30-50 ms and 75 to 95 ms, respectively). There are the corresponding average CT for groups with clearly different lower leg mass, the relatively higher increase of the peaks with CT between 60-70 ms after a maximal voluntary contraction (MVC) of 10 seconds, the higher average tensions for the ST-peaks by long distance runners and the results for the CT when the lower leg mass is artificially elevated. Furthermore the mechanogrammes of the long distance runners show that the maximum may come to a CT of 100-130 ms.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗

[The application of methodological aspects of the social sciences to psychoanalytic research--impressions from Tutzing, 1976].

Discussing problems in the application of methodological aspects of social sciences to psychoanalytic research the question was asked whether statistical methodology can be adapted to the multidimensional communicative process of psychoanalysis. Referring to the fact that experimentally and methodologically confirmed research usually demands a reduction of the process to be examined it was pointed out that the results of these studies might undergo a reduction in statement value and practicable clinical relevance accordingly.

Humans↗

Methodological issues in epidemiologic studies of dietary fat and cancer.

Every scientific discipline has unique methodological constraints. Each scientific discipline also has differing degrees of power to resolve different questions. The methods of epidemiology are not exempt from these generalizations. In this brief review, several categories of methodological problems in epidemiological studies of dietary fat and cancer have been cited. Other problems could have been discussed and, several more examples illustrating the occurrence of the problems in research could have been presented. These problems notwithstanding, epidemiologic study of the association of dietary fat to cancer is an essential investigative tool in moving toward a better understanding of the public health impact of dietary fat. There are no known biological universals, and, as persuasive as data from animal models may be, extrapolation from the laboratory environment to human experience always is tentative. Laboratory methods require human validation before application to populations at risk of disease. Given the mutual dependency of epidemiologic studies and laboratory approaches, it is useful that the evidence from both realms be integrated and evaluated together as they are in this volume. Finally, given the limitations of any single epidemiologic method applied to the topic, future progress in understanding the role of dietary fat in cancer cause and prevention must rely on the application of multiple methodologies. By this means, it may be possible to compare and contrast the findings from different approaches to yield insights which would not otherwise be achievable.

Dietary Fats↗

A research programme in lifestyle and health: methodological and theoretical considerations.

Traditionally, research in health behaviour has been dominated by research ideologies and methods which developed in the health sciences and the social sciences. To a great extent these subjects have followed "classical" research designs propounded by the natural sciences. The result has been a marked dependency on survey research, quasi-experimental designs, case-control studies and other "static" designs. This research has been characterised by brief periods of intensive "data-collection", followed by long periods of analysis and report writing. These research endeavours often constitute an extensive, elaborate, and usually accurate picture of health attitudes, opinions and behaviours at the point of data collection. But they are simply "snapshots" of a group, culture, nation, etc. at one moment in time. This research is not "dynamic" and it is not surprising that despite the considerable amount of health behaviour research which exists, we still know relatively little about the process and dynamics of health behaviour change. Fortunately there is increasing concern, both theoretical and methodological, with the problem of behavioural change over time. On balance, the theoretical arguments are not well developed, however the methodological techniques for exploring continuous data are becoming available. This paper presents one model for an emerging research programme in lifestyle and health which attempts to address some of the theoretical and methodological issues discussed.

Adult↗

[Clinical trials in psychiatry. Recent evolution of the methodology in France (author's transl)].

The comparison, with the help of a check list of criteria, of psychotropic clinical trials published in France, with an interval of five years, covered 80 trials in 1970 and 75 trials in 1975. The differences found between these two years all indicate a stricter methodological approach in 1975. Certain gaps persist however, such as the extreme rarity of codified pretherapeutic evaluation, preliminary wash out periods, references to an official nosography and a sufficient homogeneity of treatment groups. On the other hand, in the majority of trials, the exclusion criteria are not given and a global clinical assessment is the only criterium of change used. Finally the conclusions proposed coincide with the data in only two thirds of the publications. The comparative revue of 120 controlled psychotropic trials so far published in French show above all the extreme variability of the type of control utilized. Only 58 trials out of 120 have been randomized and a minority of these were carried out according to a strict methodology, with quantitative evaluation of the results and an appropriate statistical analysis. The most frequent methodological insufficiences are the obvious heterogeneity of the treatment groups, the insufficient use of standardized evaluation instruments and the inadapted ness of certain experimental protocols to the goals being pursued. The points most frequently omitted in the presentation of the results are the drop-outs of treatment, information relating to associated and previous treatment, the dates of evaluation of the therapeutic effects as well as the approach used to established side effects. The recent application of the 1975 French Law has deeply changed the habits of French experimentators and it is necessary to correctly interpret the term of "control". The control of non-specific variables intervening in the therapeutical results is the only means of identifying the pharmacological effects of drugs. The best control of these variables is the randomized comparative trial of simultaneous treatment groups using double-blind prescriptions. In order to further comparisons of trials from different sources, it is absolutely necesary that evaluation studies in French be carried out and transmitted according to internationally recognized recommendations based on general rules of protocols and on standardized evaluation instruments.

Anti-Anxiety Agents↗