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PubMed2005

[Economic evaluation studies in health].

Clinical journals often publish economic evaluation studies of health technologies and programs. To improve the peer review process and, hence, the quality and validity of published studies, the British Medical Journal (BMJ) established publication guidelines for the publication of economic evaluations aimed at authors, reviewers and editors. The present article analyzes the opportunity of adopting the BMJ's or similar guidelines by Medicina Clínica and the probable effectiveness of this measure. The article concludes that although this initiative would probably improve the review process and the quality of the papers published, it might be worthwhile to review, up-date and adapt the BMJ guidelines to the Spanish context by means of a consensus-forming process. Finally, this article discusses the limitations of the peer review process in improving the quality and validity of economic evaluations and suggests some complementary measures, drawing on lessons and experiences from the field of clinical research.

Authorship↗

PubMed2006

Cell-free artificial liver support: design of appropriate clinical studies.

The clinical use of cell-free liver support devices is dependent upon proof of safety and efficacy in clinical trials. The current published data to support their use is limited in both quantity and quality. In most studies, the methodology is such that the effects of these devices are difficult to establish with certainty. Bias might be introduced by the use of uncontrolled studies, and in randomized controlled trials limited size, poorly matched control groups or medical therapy or the use of clinically inappropriate endpoints might be important. Guidelines are now available to provide a framework for the design and execution of such trials, specifically to minimize the systematic errors that are frequently present and that might result in biased estimates of treatment effects. In the present review, the limitations of current studies are discussed and suggestions made as to the design and conduct of future clinical trials.

Biomedical Research↗

PubMed2004

Medicare proposal may benefit insurers.

The proposed guidelines from U.S. Pharmacopeial Convention Inc., which was assigned the task by last year's Medicare law, seek a middle ground between pharmaceutical companies and insurers. The USP proposal is expected to result in a final plan after the organization takes comments. It is also supposed to define a list of classes of drugs--more formally divided into therapeutic areas and pharmacologic subcategories.

Drug Industry↗

PubMed1995

Clinical assessment of osteoarthritis in clinical trials.

The emergence of various therapeutic possibilities in the field of osteoarthritis has strongly prompted clinicians to conduct studies to evaluate the symptomatic as well as the potential chondromodulating effects of these treatments. For this purpose, some authors recently proposed guidelines with regard not only to the potential outcome variables to assess cartilage breakdown but also the characteristics of both the patients and the osteoarthritis in demonstrating chondromodulating effects. The most clinically relevant variable will be chosen (with regard to simplicity as well as reliability, validity, and responsiveness). This variable will be applied in the particular subgroup of patients who show predictive factors of osteoarthritis progression.

Clinical Trials as Topic↗

PubMedDate not supplied

[Proposal of guidelines for the set-up of pharmaco-epidemiologic studies in drug surveillance].

In the light of recent experiences and anticipating an increase in similar requests in the future, it seemed very interesting to a drug safety executives' group from the pharmaceutical industry to propose guidelines for the set-up and follow-up of pharmacoepidemiological studies requested by Health Authorities for the assessment of drug risk. The scope of these guidelines is to establish the responsibility of the teams and structures involved in the study, to define the necessary stages set-up, and to determine the rules in order to ensure its smooth running from the drafting of the protocole to the final use of the data.

Clinical Trials as Topic↗

PubMedDate not supplied

Commentary on the consensus recommendations for the post mortem diagnosis of Alzheimer's disease.

The consensus recommendations for the post mortem diagnosis Alzheimer's disease (AD) highlight the difficulties in establishing a pathological diagnosis in brains from clinically demented individuals with both certainty and uniformity. There is, however, a need for diagnostic guidelines that are relatively simple, inexpensive, and adaptable to general pathologists and different laboratories. The current Consortium to Establish a Registry for Alzheimer's disease (CERAD) criteria and the recommendations in the consensus document giving three probabilistic categories for diagnosis go a long way towards establishing a uniform approach for the diagnosis of AD. However, more uniformity could be adopted in the topography of sectioning to enhance diagnostic and future research comparisons. We also recommend that immunohistochemistry for beta A4 (A beta) amyloid and tau-reactive neurofibrillary changes, in addition to hematoxylin and eosin stains, should become the basis for histological diagnosis. We agree with the guidelines concerning documentation of all AD changes. Until a clearer understanding of the early changes of AD is established, strict observation and recording are the pathologists' best diagnostic skills. The ill-defined diagnostic areas of AD continue to prompt the need for a new method of detection of the underlying pathologic process.

Aged↗

PubMed2003

Measuring response in solid tumors: comparison of RECIST and WHO response criteria.

BACKGROUND: Objective tumor response is a common endpoint in daily practice as well as in clinical trials to evaluate the efficacy of anti-cancer agents. Traditionally, the standard World Health Organization (WHO) criteria has been adopted in these contexts. However, the recent development of new classes of anti-cancer agents and progress in imaging technology have required new methodology to evaluate response to treatment. Recently, the Response Evaluation Criteria in Solid Tumors Group (RECIST) proposed new guidelines using unidimensional measurement. Theoretically, the simple sum of the maximum diameters of individual tumors is more linearly related to cell kill than is the sum of the bidimensional products. To validate these new guidelines, we have compared the standard WHO response criteria with the new RECIST guidelines in the same patient population. METHODS: Data from 79 patients enrolled in eight prospective phase II studies at Samsung Medical Center were retrospectively re-analyzed to determine the concordance between the two response criteria. The two response criteria were applied separately, and the results were compared using the kappa statistic to test concordance for overall response rate. RESULTS: The overall response rate according to the WHO criteria was 31.6%. Using the RECIST criteria, nine patients were reclassified and the overall response rate was 30.4%. There was excellent agreement between the unidimensional and bidimensional criteria in 23 of 25 responses (92%). The kappa statistic for concordance for overall response was 0.91. CONCLUSIONS: We conclude that the new RECIST guidelines are comparable to the old response criteria in evaluating response in solid tumors. Moreover, the new guidelines are just as simple and reproducible in the measurement of response in daily practice as they are in clinical trials.

Antineoplastic Agents↗

PubMed1994

Intraarticular treatment of osteoarthritis and guidelines to its assessment.

Intraarticular treatment has been considered for osteoarthritis since the first attempts at local injection of steroid derivatives. To assess the effectiveness of intraarticular drugs, in view of the variability of the disease and the remarkable placebo response, a control group of patients is necessary. The main outcome measures are pain and joint effusion when using symptomatic slow acting drugs. If a chondroprotective effect is to be demonstrated the main criterion is measurement on standardized radiography of the knee medial femorotibial joint space.

Clinical Trials as Topic↗

PubMed2005

Evolution of methodological standards in surgical trials.

BACKGROUND: The Consolidated Standards of Reporting Trials (CONSORT) Statement outlines acceptable ways of performing and reporting clinical trials. The objective of the present study was to identify evolving patterns in the methodological standards of surgical trials. METHODS: Compliance with 12 key standards from the CONSORT statement were evaluated in 490 trials published in either the ANZ Journal of Surgery or the British Journal of Surgery between January 1969 and December 2003. RESULTS: There has been an irregular but progressive improvement in the methodological standards of published trials. The criteria with the greatest improvement related to estimation of sample size, randomization, concealment of the allocated intervention, baseline comparisons, and the method of expressing outcomes. Compliance rates were <50% for three criteria during the last decade of the review, that is, concealment of the allocated intervention, blindness of assessment, and the method of expressing outcomes. CONCLUSION: The results of surgical trials need to be interpreted with care.

Australia↗

PubMedDate not supplied

The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."

Bias↗

PubMed2003

Impact of a web-based antimicrobial approval system on broad-spectrum cephalosporin use at a teaching hospital.

OBJECTIVE: To achieve sustained improvement in use of cefotaxime and ceftriaxone (CEFX) in a major teaching hospital, as measured against national antibiotic guidelines. DESIGN AND SETTING: Pre- and post-intervention survey of CEFX use in the Royal Melbourne Hospital, a tertiary hospital in Melbourne, Victoria. INTERVENTION: Web-based antimicrobial approval system linked to national antibiotic guidelines was developed by a multidisciplinary team and implemented in March 2001. MAIN OUTCOME MEASURES: Change in rate of CEFX use (defined daily doses [DDDs] per 1000 acute occupied bed days) over 8 months pre- and 15 months post-intervention; concordance of indication for CEFX with national antibiotic guidelines pre- and post-intervention. RESULTS: CEFX use decreased from a mean of 38.3 DDDs/1000 bed days pre-intervention to 15.9, 18.7 and 21.2 DDDs/1000 bed days at 1, 4 and 15 months post-intervention. Concordance with national antibiotic guidelines rose from 25% of courses pre-intervention to 51% within 5 months post-intervention (P < 0.002). Gentamicin use also increased, from a mean of 30.0 to 48.3 DDDs/1000 bed days (P = 0.0001). CONCLUSION: The web-based antimicrobial approval system achieved a sustained reduction in CEFX use over 15 months as well as increased prescribing concordance with antibiotic guidelines. It has potential for linking to electronic prescribing and for wider use for other drugs, as well as for research into the epidemiology of antibiotic use.

Anti-Bacterial Agents↗

PubMed2004

Clinical utility as a criterion for revising psychiatric diagnoses.

OBJECTIVE: Changes in DSM-IV were guided by empirical data that mostly focused on improving diagnostic validity and reliability. Although many changes were made explicitly to improve clinical utility, no formal effort was made to empirically determine actual improvements in clinical utility. The authors propose that future revisions of DSM empirically demonstrate improvement in clinical utility to clarify whether the advantages of changing the diagnostic criteria outweigh potential negative consequences. METHOD: The authors provide a formal definition of clinical utility and then suggest that the merits of a proposed change to DSM be evaluated by considering 1) its impact on the use of the diagnostic system, 2) whether it enhances clinical decision making, and 3) whether it improves clinical outcome. RESULTS: Evaluating a change based on its impact on use considers both user acceptability and accuracy in application of the diagnostic criteria. User acceptability can be measured by surveying users' reactions, assessing user acceptability in a field trial setting, and measuring the effects on ease of use. Assessment of the correct application of diagnostic criteria entails comparing the clinician's diagnostic assessment to expert diagnostic assessment. Assessments of the impact on clinical decision making use methods developed for evaluating adherence to practice guidelines. Improvement in outcome entails measuring reduction in symptom severity or improvement in functioning or in documenting the prevention of a future negative outcome. CONCLUSIONS: Empirical methods should be applied to the assessment of changes that purport to improve clinical utility in future revisions of DSM.

Attitude of Health Personnel↗

PubMed2001

Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations.

Acupuncture treatment and control group interventions in parallel-group randomised trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA: STandards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journals are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis and replication of trials.

Acupuncture Therapy↗

PubMed1998

Long-term changes in compliance with clinical guidelines through computer-based reminders.

We evaluate the effectiveness of computer-based reminders in improving compliance with preventive medicine screening guidelines and examine the long-term impact of these reminders. Physicians in an ambulatory care practice were given a summary health maintenance report of preventive screening items at each scheduled patient visit. The electronic medical record (COSTAR) in use in this practice was programmed to integrate 13 clinical guidelines into the routine flow of care. Mean performance of 10 out of 13 health maintenance measures improved in the year following introduction of the integrated guideline report (p less than .001 by chi-square test for 8 items, p less than .01 for 2 items). Five years after the report was introduced, improvement in mean performance persisted for 7 measures (p less than .001 by chi-square test), compliance improved for one additional measure (p less than .001), and improvement disappeared for three measures that had shown improvement in the first year of the intervention.

Evaluation Studies as Topic↗

PubMed1999

[European strategy for control of resistance to antibiotics].

The problem of international spread of bacterial resistance requires development of a strategy at worldwide or at least at European level. Clinically relevant monitoring systems for resistance and use of antibiotics have to be implemented to support the guidelines on prescription of antibiotics. Every hospital should establish an 'antibiotics team' controlling the prescription of antimicrobials and the observance of local formulary agreements. Veterinary use of growth promoting antimicrobials related to substances used in human medicine should be terminated. Future research should be aimed at resolving the problem of resistance to antimicrobials.

Animals↗

PubMed2002

Standards for Reporting Interventions in Controlled Trials of Acupuncture: the STRICTA recommendations.

Acupuncture treatment and control group interventions in parallel-group randomized trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA: STandards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journals are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis and replication of trials.

Acupuncture Therapy↗

PubMed1995

Using Oncology Nursing Society Cancer Chemotherapy Guidelines as a basis for continuing education in rural hospitals.

PURPOSE/OBJECTIVES: To describe a workshop developed to teach nurses caring for patients with cancer in a southern, rural area how to administer chemotherapy in an inpatient or homecare setting. DATA SOURCES: The Oncology Nursing Society (ONS) Cancer Chemotherapy Guidelines and published articles and books. DATA SYNTHESIS: An oncology clinical nurse specialist teaching at a local university developed and presented 10 hours of didactic content and a 6-hour clinical practicum. The workshop was conducted in association with a community hospital, which offered oncology care to patients with cancer in the community. CONCLUSIONS: All nurses who successfully completed the workshop demonstrated improved ability in caring for patients with cancer and in administering chemotherapy. The ONS Cancer Chemotherapy Guidelines provided an excellent outline for the development of an initial course on the science of chemotherapy and management of related symptoms. IMPLICATIONS FOR NURSING PRACTICE: Many nurses work in rural areas where they are expected to provide competent nursing care to a variety of specialized patient populations, yet they have limited access to educational opportunities. A workshop format is feasible and can provide the education necessary for nurses who care for patients with cancer.

Antineoplastic Agents↗

PubMed1999

A database system for integrated clinical trial management, control, statistical analysis and ICH-compliant reporting.

Clinical trial management and quality assurance is a complex activity that, when manually executed, is prone to errors and delays, and organizations involved in the conduct of clinical drug trials must rely on database systems to ensure adequate data integrity and timely reporting. We report the design and implementation of an integrated computer system for the management and control of multiple phase II to IV clinical drug trials, and for automated generation of monitoring and statistical analysis reports that are fully compliant with international guidelines. This Windows-based system incorporates a number of third-party software tools and applications, and its major components are COATI (Control, Assessment and Tracking of Therapeutic Investigations), a client-server database application; DART (Data Analysis and Reporting Tool) for automated data abstraction and reporting; and PANDA (Data Analysis Package) for automated statistical analysis. The system is in production for two years and was used in 15 clinical trials in a diversity of medical conditions and study designs.

Clinical Trials as Topic↗