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PubMed2003

Randomized controlled trials in pediatric surgery: could we do better?

BACKGROUND/PURPOSE: Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the effectiveness of clinical interventions but are rarely reported in pediatric surgery. Have RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5 years been adequately designed and large enough to produce a valid result? METHODS: Abstracts accepted by the Annual BAPS Congress meetings between 1996 and 2000 were examined in collaboration with a senior health services researcher. The quality of the design, methodology, statistical analysis and conclusions, and the adequacy of the sample size were assessed for all identifiable clinical RCTs. RESULTS: From 760 accepted abstracts, there were only 9 RCTs (1%) of clinical interventions. In only 4 trials was the relevant primary end-point specified at the outset of the study, and none documented the method of randomization. Only one abstract mentioned blinding with respect to the intervention or outcome measure. Sample sizes were inadequate to detect even large clinical differences. To date, only one of these RCTs has been published in an English-language, peer-reviewed journal. CONCLUSIONS: Clear guidelines exist for the conduct of RCTs, yet compliance with these standards was rarely documented in abstracts of pediatric surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric surgery are difficult to perform, but the specialty would benefit from well-designed, carefully conducted, multicentre, clinical RCTs to advance evidence-based practice.

Bibliometrics↗
PubMedDate not supplied

An independent AGREE evaluation of the Occupational Medicine Practice Guidelines.

BACKGROUND AND CONTEXT: A large number of practice guidelines are being produced by numerous organizations. Health-care professionals need to critically evaluate these practice guidelines to understand whether they are well constructed and representative of the preponderance of evidence. The guideline development process should be precise and rigorous to ensure that the results are reproducible and not vague. PURPOSE: To evaluate the quality of the second edition of the practice guidelines published by the American College of Occupational and Environmental Medicine (ACOEM Guidelines). STUDY DESIGN/SETTING: Four appraisers used the AGREE (Appraisal of Guidelines Research and Evaluation) guideline evaluation instrument to evaluate the ACOEM Guidelines. METHODS: The Guidelines were evaluated with the AGREE guideline evaluation instrument. The AGREE instrument has been widely adopted around the world, and the authors recommended that it be adopted as the standard of guideline construction process evaluation in the United States. The instrument standardizes the quantitative assessment of quality for a guideline's development process across six domains that include: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, application, and editorial independence. Scores from four assessors were collected and interpreted. Additionally, each evaluator selected one of four global assessment choices: "strongly recommended for use in practice," "recommended for use with some modification or proviso," "not recommended as suitable for use in practice," or "unsure". RESULTS: The ACOEM Guidelines scored highest in the dimensions that evaluated reporting of the guideline's scope and purpose (79.63) as well as clarity and presentation (86.81). The guideline scored much lower in the remaining areas that included stakeholder involvement (46.06), rigor of development (26.59), application (31.48), and editorial independence (19.17). The global assessment was unanimous with all four evaluators assessing the guideline as recommend with proviso. CONCLUSIONS: Many of the Guidelines recommendations were consistent with current literature and guidelines; however, the AGREE assessment instrument evaluates the guideline development process and not the content. All the evaluators thought the content of the guidelines was substantially better than the documentation of the guideline construction process. The ACOEM Guidelines appear to have content consistent with their stated objectives, but the reporting of the guidelines construction process, particularly the rigor of recommendation development, is flawed, and the recommendations may not be valid owing to possible evidence selection deficiencies. The reader should consider these flaws and limitations when using the guideline. The reader should consider utilizing guidelines of higher quality when possible. Future guidelines should incorporate better reporting and give closer attention to guideline construction.

Attitude of Health Personnel↗
PubMed2001

Evaluation of biological effects, dosimetric models, and exposure assessment related to ELF electric- and magnetic-field guidelines.

Several organizations worldwide have issued guidelines to limit occupational and public exposure to electric and magnetic fields and contact currents in the extremely low frequency range (<3 kilohertz). In this paper, we evaluate relevant developments in biological and health research, computational methods for estimating dosimetric quantities, and exposure assessment, all with an emphasis on the power frequency (60 hertz in North America, 50 hertz in Europe). The aim of each guideline is to prevent acute neural effects of induced electric fields. An evaluation of epidemiological and laboratory studies of neurobiological effects identified peripheral nerve stimulation as the response most suitable for establishing a magnetic-field guideline. Key endpoints that merit further study include reversal of evoked potentials; cardiovascular function, as measured by heart rate and heart rate variability; and sleep patterns. High-resolution computations of induced electric fields and current densities in anatomically correct human models are now achieved with finite-difference methods. The validity and limitations of these models have been demonstrated by computations in regular geometric shapes, using both analytic and numeric computations. Calculated values for average dosimetric quantities are typically within a few percent for the two approaches. However, maximum induced quantities are considerably overestimated by numerical methods, particularly at air interfaces. Overestimates are less pronounced for the upper 99th percentile level of a dosimetric quantity, making this measure a more useful indicator of maximum dose. Neural stimulation thresholds are dependent on the electric field around the excitable cell rather than on the current density, making the former preferable for expression of basic restrictions based on nervous system function. Furthermore, modeling data indicate that the induced electric field is much less strongly influenced by tissue conductivity than is the induced current density. In the electric utility industry, most magnetic-field exposures at or near guideline levels occur in highly nonuniform fields. Two methods are described for simplified estimation of induced quantities in such fields, with each method using as input modeling results for uniform field exposure. These methods have practical value for assessing occupational exposures relative to guideline levels.

Air Pollutants, Radioactive↗
PubMed1998

The role of self-treatment guidelines in self-management education for adult asthmatics.

Guidelines on asthma management have changed considerably in the last two decades. Patient education has gained in popularity and especially asthma self-management training is thought to be essential in the treatment of adult asthma. Since 1989 many researchers have added self-treatment guidelines to self-management programmes and several studies have found improvements in health outcomes, such as lung function, quality of life, use of health care facilities and asthma symptoms. However, because of the lack of proper control groups, it is not clear whether this has to be attributed to self-treatment guidelines or to, for example, more education or more medical attention. The only two studies that were placebo controlled did not show an effect of self-treatment. To assess the added benefit of self-treatment guidelines to a self-management programme, randomized 'placebo' controlled trials of sufficient size with sufficient follow-up time are necessary. The only difference between intervention and control groups should be guidelines for self-treatment.

Adult↗
PubMedDate not supplied

Evidence-based and value-based formulary guidelines.

Health plans and hospitals have long used drug formularies, but the processes by which formulary committees made decisions have typically lacked transparency and scientific rigor. A growing number of organizations have begun implementing formulary guidelines issued by the Academy of Managed Care Pharmacy (AMCP). These guidelines call for health plans to request formally that drug companies present a standardized "dossier" that contains detailed information not only on the drug's effectiveness and safety but also on its economic value relative to alternative therapies. This paper describes the guidelines, reviews progress to date, and analyzes several critical issues for the future.

Decision Making, Organizational↗
PubMed2004

Periodontics and the new CDC guidelines.

On December 19, 2003, the Centers for Disease Control and Prevention released the Guidelines for Infection Control in Dental Health-Care Settings--2003. The publication was the first comprehensive dental infection control update since 1993. Although the guidelines are not directed toward a particular dental specialty, some recommendations may have a significant impact on the practice of periodontics because of the nature of the procedures that are considered routine to the specialty. This article deals with some of the issues addressed in the guidelines, highlighting topics of special interest to periodontists.

Centers for Disease Control and Prevention, U.S.↗
PubMed1999

Transatlantic Conference on Clinical Trial Guidelines in Peripheral Arterial Disease: clinical trial methodology. Basel PAD Clinical Trial Methodology Group.

Guidelines for the clinical development of drugs in peripheral arterial disease (PAD) have been issued by the Food and Drug Administration for the United States and by the regulatory agency of the European Union for Europe. With increasing globalization, transatlantic cooperation in drug research and development is essential for the future and would be substantially facilitated by the existence of transatlantic guidelines. A conference was held in Basel, Switzerland, in November 1997 to discuss the scientific background of the existing guidelines on the basis of published evidence and the extensive knowledge of clinical investigators and experienced regulators. The meeting was attended by 52 invited experts from the United States and Europe, as well as by representatives from the 2 regulatory authorities. The main conclusions from the meeting are presented and may serve as a reference for the future development of transatlantic guidelines for the evaluation of pharmacotherapy in PAD.

Clinical Trials as Topic↗
PubMed1998

The distribution of health care costs and their statistical analysis for economic evaluation.

OBJECTIVE: Where patient level data are available on health care costs, it is natural to use statistical analysis to describe the differences in cost between alternative treatments. Health care costs are, however, commonly considered to be skewed, which could present problems for standard statistical tests. This review examines how authors report the distributional form of health care cost data and how they have analysed their results. METHOD: A review of cost-effectiveness studies that collected patient-level data on health care costs. To supplement the review, five datasets on health care costs are examined. Consideration is given to the use of parametric methods on the transformed scale and to non-parametric methods of analysing skewed cost data. RESULTS: Since economic analysis requires estimation in monetary units, the usefulness of transformation-based methods is limited by the inability to retransform cost differences to the original scale. Non-parametric rank sum methods were also found to be of limited use for economic analysis, partly due to the focus on hypothesis testing rather than estimation. Overall, the non-parametric approach of bootstrapping was found to offer a useful test of the appropriateness of parametric assumptions and an alternative method of estimation where those assumptions were found not to hold. CONCLUSIONS: Guidelines for the analysis of skewed health care cost data are offered.

Cost-Benefit Analysis↗
PubMed2006

Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity.

BACKGROUND: It is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria. METHODS: The checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias) correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation. RESULTS: A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemized and transformed into a questionnaire format. CONCLUSION: The checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.

Bias↗
PubMed1992

Aeromedical transport services accepting pediatric patients and their abidance by published guidelines.

The number of aeromedical transport services accepting pediatric patients (ATSP) in the United States has increased greatly over the past decade. Most aeromedical transport services are primarily designed for adults but will also transport children. Suggested guidelines for ATSP were published by the American Academy of Pediatrics (AAP) in 1986. This survey of 65 ATSP and their abidance by the major AAP guidelines showed that two thirds of the ATSP were based at facilities with pediatric tertiary care capabilities; most ATSP were not directed by pediatric critical care (PCC) or pediatric emergency care (PEC) specialists; most transport team personnel were not trained in PCC or PEC; most ATSP had specific protocols for different clinical situations; most ATSP had separate equipment appropriate for pediatric patients; and there was little variation in transport team composition based on different clinical situations. In summary, all ATS surveyed transported children, but few were aware of the AAP guidelines, and only one in 65 was in complete abidance with the recommendations.

Adult↗
PubMed2006

Use of preventive measures for air travel-related venous thrombosis in professionals who attend medical conferences.

BACKGROUND: Lack of guidelines for prevention of air travel-related venous thrombosis may lead to excessive use of potentially dangerous precautions. OBJECTIVES: To assess the use of preventive measures for air travel-related thrombosis in professionals employed in the field of thrombosis and hemostasis and in other fields. METHODS: A survey amongst delegates of the XXth ISTH Congress, the 15th ISDB Congress and the 13th Cochrane Colloquium, which all took place in Australia 2005. RESULTS: Two thousand and eighty-nine questionnaires were completed (response 53%). Overall, 80% of the respondents had used preventive measures. Low-molecular-weight heparin and vitamin K antagonists were mostly used by ISTH delegates (10% vs. 1% at the other conferences). Medical doctors used more pharmacological prophylaxis (31%) than research fellows (11%) and non-clinical scientists (22%). Dutch (64%) and Asian respondents (67%) least used any prevention, whereas Israeli used most (94%). Subjects with risk factors for thrombosis more often used prophylaxis (90%) than those without (77%). In a multivariate analysis, conference, nationality, age, presence of risk factors and profession were determinants of prophylaxis use. CONCLUSION: Major differences in the use of prophylactic measures for air travel-related thrombosis stress the need for studies of interventions and clear guidelines on prevention of air travel-related venous thrombosis.

Aircraft↗
PubMed1999

[Recommendations on care of back pain problems].

Back problems are a common cause of disability. There are important variations in the care provided, suggesting that some patients receive suboptimal treatment. Several Western countries have developed practice guidelines to improve this state of affairs. If guidelines are to improve the outcome for patients seeking care, they must give valid recommendations. In this article I compare ten practice guidelines for back problems. The guidelines are from nine Western countries and were published in the ten-year period 1987-97. There are significant variations in the recommendations given. The guidelines were developed according to different methods. A systematic, evidence-based approach is less prone to bias than an informal expert-based consensus. I conclude that the systematically developed US guideline (AHCPR 1994) and the British guideline (RCGP 1996) are the ones giving valid recommendations and are therefore the best options for practitioners.

Australia↗
PubMed1994

Quantitative audit of the content of histopathology reports.

An audit of histopathology reports presents the problem that the output is textual and difficult to quantify. This makes the definition of an adequate report subjective and susceptible to observer variation. A procedure has been developed which allows the quantitative analysis of reports and facilitates the development of local reporting guidelines. A topic is selected; the auditor then lists the possible details that may be included in the report and notes how many reports from a sample include each detail. The results are discussed at a departmental meeting with the aim of agreeing on reporting guidelines. At a later date another sample of reports can be analysed for compliance with the guidelines and compared with the previous reports. Problems with compliance can be discussed further and at the audit meeting the guidelines may be amended appropriately, thus completing the audit cycle. This method of audit has the advantage that the results are quantitative and that the group discussion and re-examination of the guidelines has educational value.

Humans↗