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PubMed2002

Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. STandards for Reporting Interventions in Controlled Trails of Acupuncture.

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 journal editors 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↗

PubMed1999

Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group.

PURPOSE: Prostate-specific antigen (PSA) is a glycoprotein that is found almost exclusively in normal and neoplastic prostate cells. For patients with metastatic disease, changes in PSA will often antedate changes in bone scan. Furthermore, many but not all investigators have observed an association between a decline in PSA levels of 50% or greater and survival. Since the majority of phase II clinical trials for patients with androgen-independent prostate cancer (AIPC) have used PSA as a marker, we believed it was important for investigators to agree on definitions and values for a minimum set of parameters for eligibility and PSA declines and to develop a common approach to outcome analysis and reporting. We held a consensus conference with 26 leading investigators in the field of AIPC to define these parameters. RESULT: We defined four patient groups: (1) progressive measurable disease, (2) progressive bone metastasis, (3) stable metastases and a rising PSA, and (4) rising PSA and no other evidence of metastatic disease. The purpose of determining the number of patients whose PSA level drops in a phase II trial of AIPC is to guide the selection of agents for further testing and phase III trials. We propose that investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period. Some investigators may want to report additional measures of PSA changes (ie, 75% decline, 90% decline). Response duration and the time to PSA progression may also be important clinical end point. CONCLUSION: Through this consensus conference, we believe we have developed practical guidelines for using PSA as a measurement of outcome. Furthermore, the use of common standards is important as we determine which agents should progress to randomized trials which will use survival as an end point.

Androgens↗

PubMed2005

The current state of in-vivo pre-clinical animal models for heart valve evaluation.

For over 30 years, animal models have remained a central critical component in the pre-clinical safety evaluation of prosthetic heart valves developed for use in humans. Though many advances have been made in valve design, no ideal replacement prosthesis has yet been developed. As a result, valve manufacturers continue to address issues relating to thrombogenicity, structural integrity, fluid dynamics and calcification in their designs. Many animal models have been developed to examine these issues, including dog, pig, calf and sheep, yet no standard model has been accepted. Recently, the International Standard Organization has provided guidelines in document 5840 to address cardiovascular implants. The aim of this report is to provide a summary of the current state of pre-clinical valve evaluation in animals. Changes in ISO 5840 will be addressed that have occurred between 1998 and the present date, and the role of current available animal models. The aim also is to provide rational guidance in the selection of appropriate animal models to match the purpose of valve implantation studies.

Animals↗

PubMed1998

Checking the anaesthetic machine: self-reported assessment in a university hospital.

Checking the anaesthetic machine before its daily use is essential. The aim of our study was to evaluate, through the use of an anonymous questionnaire, how the anaesthetists of our institution (physicians and nurses) report their daily checking. Sixty-three questions were used to ask the participants how frequently they checked the main components of the anaesthetic machine; the answers were evaluated with a score (0-3). The overall response rate was 78%, nurses; rate being lower than physicians' rate. Nurses obtained a higher global score, which raises the question of different adherence to guidelines by nurses and physicians. Moreover, questions in relation to gas supply were badly scored by all participants, which should alert us to reinforce theoretical and practical training in these items. Finally, although the methodology used in this survey could raise the question of the best way to evaluate the actual checkout procedure, self-reported assessment remains an alternative to more complex and expensive methods, such as an observer or a video evaluation.

Analysis of Variance↗

PubMed2004

Focusing pharmacoeconomic activities: reimbursement or the drug life cycle?

The purpose of this paper is to consider the role of pharmacoeconomic activities in the drug life cycle and not just as activities to support reimbursement applications and market entry. These activities are important in establishing the value case for a drug product to both internal and external audiences. Unless these activities are fully integrated into establishing the business case for a product from the pre-phase I period of drug discovery, manufacturers run the risk of establishing a unit price for the product and claims for cost-effectiveness which are inconsistent with achieving reimbursement. Importantly, manufacturers need to consider at an early stage the evidentiary and analytical needs for product evaluation under formulary submission guidelines (AMCP; NICE) and the integration of pharmacoeconomic activities over the life cycle. These activities include justifying assumptions for business opportunity assessments and an early commitment to developing a mock reimbursement submission at post-phase II. The integration of pharmacoeconomic activities in the drug cycle is not only an antidote to excessive clinical optimism but also provides the basis for an effective assessment of the likely performance of new products in the health-care market place at a price and formulary position acceptable both to the manufacturer and the reimburser.

Australia↗

PubMed1998

Comparing 1997 Resuscitation Council (UK) recovery position with recovery position of 1992 European Resuscitation Council guidelines: a user's perspective.

Both the 1992 and the 1997 recovery positions were demonstrated to 100 employees attending for Basic Life Support resuscitation training at a district general hospital (Chesterfield and North Derbyshire Royal Hospital NHS Trust). They used both positions, experiencing being the first-aider and the casualty and then completed a closed questionnaire. The results were evaluated from this 100% response. In every aspect the 1992 or 'How' position was preferred both in terms of ease of use and comfort during the procedure by the majority of each sample group. In every comparison the 1992 position was preferred highly significantly, (P < 0.001) using chi-square statistical analysis.

Cardiopulmonary Resuscitation↗

PubMed2004

Professionals' awareness of operational antibiotic prescribing controls in UK NHS hospitals.

In recent years, there have been increasing recommendations for multidisciplinary collaboration between clinical pharmacists and medical microbiologists in an attempt to control the quality (and quantity) of antibiotic prescribing. A questionnaire addressing the utilization of antibiotic prescribing controls was sent to the chief pharmacist and medical microbiologist in UK NHS hospitals. Responses were received from both the chief pharmacist and the medical microbiologist employed in the same hospital from 83 hospitals (a 30% response rate from two independent studies). A high level of disagreement and poor awareness was identified between the interprofessional staff groups regarding the existence of antibiotic formulary (with disagreement between the two groups, or not known by one or both respondents, in 46% of the paired hospitals, N = 38) and guideline documents (13%, N = 11), performance of antibiotic prescribing audits (40%, N = 33), and whether pharmacists (52%, N = 43) and medical microbiologists (77%, N = 64) monitored physician compliance with antibiotic prescribing control documents. This study has identified poor knowledge of the existence of basic antibiotic prescribing control mechanisms and the role of professional colleagues. It is suggested that there is some way to go before 'Agenda for Change' principles of flexible and collaborative roles are met.

Anti-Infective Agents↗

PubMedDate not supplied

Computerized screening devices and performance assessment: development of a policy towards automation. International Academy of Cytology Task Force summary. Diagnostic Cytology Towards the 21st Century: An International Expert Conference and Tutorial.

ISSUES: The extension of automation to the diagnostic assessment of clinical materials raises issues of professional responsibility, on the part of both the medical professional and designer of the device. The International Academy of Cytology (IAC) and other professional cytology societies should develop a policy towards automation in the diagnostic assessment of clinical cytologic materials. CONSENSUS POSITION: The following summarizes the discussion of the initial position statement at the International Expert Conference on Diagnostic Cytology Towards the 21st Century, Hawaii, June 1997. 1. The professional in charge of a clinical cytopathology laboratory continues to bear the ultimate medical responsibility for diagnostic decisions made at the facility, whether automated devices are involved or not. 2. The introduction of automated procedures into clinical cytology should under no circumstances lead to a lowering of standards of performance. A prime objective of any guidelines should be to ensure that an automated procedure, in principle, does not expose any patient to new risks, nor should it increase already-existing, inherent risks. 3. Automated devices should provide capabilities for the medical professional to conduct periodic tests of the appropriate performance of the device. 4. Supervisory personnel should continue visual quality control screening of a certain percentage of slides dismissed at primary screening as within normal limits (WNL), even when automated procedures are employed in the laboratory. 5. Specifications for the design of primary screening devices for the detection of cervical cancer issued by the IAC in 1984 were reaffirmed. 6. The setting of numeric performance criteria is the proper charge of regulatory agencies, which also have the power of enforcement. 7. Human expert verification of results represents the "gold standard" at this time. Performance characteristics of computerized cytology devices should be determined by adherence to defined and well-considered protocols. Manufacturers should not claim a new standard of care; this is the responsibility of the medical community and professional groups. 8. Cytology professionals should support the development of procedures that bring about an improvement in diagnostic decision making. Advances in technology should be adopted if they can help solve problems in clinical cytology. The introduction of automated procedures into diagnostic decision making should take place strictly under the supervision and with the active participation and critical evaluation by the professional cytology community. ONGOING ISSUES: Guidelines should be developed for the communication of technical information about the performance of automated screening devices by the IAC to governmental agencies and national societies. Also, guidelines are necessary for the official communication of IAC concerns to industry, medicolegal entities and the media. Procedures and guidelines for the evaluation of studies pertaining to the performance of automated devices, performance metrics and definitions for evaluation criteria should be established.

Automation↗

PubMed1992

The Quality of Life Committee of the Clinical Trials Group of the National Cancer Institute of Canada: organization and functions.

The Quality of Life Committee of the National Cancer Institute of Canada Clinical Trials Group has successfully advocated the adoption of quality of life outcomes in Canadian clinical trials in patients with cancer. It has developed a policy promoting quality of life assessment in phase III trials and developed writing guidelines to assist clinical investigators when developing protocols for proposed studies. As a result, all phase III clinical trials instituted since the policy was developed have quality of life assessment as a part of their objectives. It has assisted the Clinical Trials Group office personnel in the development of procedures for the conduct of quality of life assessments in clinical trials with the result that the completion rate of self-report questionnaires is very high. The Committee maintains contact with other clinical trials groups and organizations having an interest in measuring quality of life in cancer.

Canada↗

PubMed1994

Guidelines for testing slow acting drugs in osteoarthritis.

New compounds appear to improve symptoms of osteoarthritis (OA), and others are putative chondroprotective agents. We suggest experimental designs for studying the effects of these agents in subjects with hip and knee OA. The course of the articular cartilage lesion is the primary outcome measure to be assessed in putative chondroprotective agent trials. Serial radiographic studies suggest that the annual rate of joint space narrowing in patients with hip or knee OA is about 0.25 mm. Other approaches to quantitation of cartilage loss, e.g., radiographic measurement of the area of joint space, ultrasonography, magnetic resonance imaging and fiberoptic arthroscopy (for knee OA) are under investigation.

Antirheumatic Agents↗

PubMed2000

An analytical model applied to a multicenter pneumococcal enzyme-linked immunosorbent assay study.

Pneumococcal conjugate vaccines will eventually be licensed after favorable results from phase III efficacy trials. After licensure of a conjugate vaccine for invasive pneumococcal disease in infants, new conjugate vaccines will likely be licensed primarily on the basis of immunogenicity data rather than clinical efficacy. Analytical methods must therefore be developed, evaluated, and validated to compare immunogenicity results accurately within and between laboratories for different vaccines. At present no analytical technique is uniformly accepted and used in vaccine evaluation studies to determine the acceptable level of agreement between a laboratory result and the assigned value for a given serum sample. This multicenter study describes the magnitude of agreement among 12 laboratories quantifying an identical series of 48 pneumococcal serum specimens from 24 individuals (quality-control sera) by a consensus immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) developed for this study. After provisional or trial antibody concentrations were assigned to the quality-control serum samples for this study, four methods for comparison of a series of laboratory-determined values with the assigned concentrations were evaluated. The percent error between assigned values and laboratory-determined concentrations proved to be the most informative of the four methods. We present guidelines that a laboratory may follow to analyze a series of quality-control sera to determine if it can reproduce the assigned antibody concentrations within an acceptable level of tolerance. While this study focused on a pneumococcal IgG ELISA, the methods that we describe are easily generalizable to other immunological assays.

Antibodies, Bacterial↗

PubMed1999

Meeting the information needs of drug purchasers: the evolution of formulary submission guidelines.

The emergence of formulary submission guidelines in the 1990s has been seen by many as an attempt to come to grips with the issue of drug management within health systems and to provide, for the first time, a coherent and methodologically rigorous approach to formulary selection. Judging from the available evidence, however, guidelines have fallen far short of their potential. The purpose of this paper is to consider what role guidelines have played in health system management and whether they play a useful role in providing a methodologically sound basis for drug-impact assessment. Two polar cases in guideline development are examined: the Australian guidelines first published in 1992 and now undergoing a second major revision and the guidelines recently published by Blue Cross and Blue Shield of Colorado and Nevada. The former guidelines represent what can be described as the traditional, clinical paradigm of drug-impact assessment; the latter represent what can be called the system-impact paradigm. The argument put forward is that the Australian guidelines are essentially an anachronism, offering little to those whose principal concern is with the management of health systems. In their emphasis on a hierarchy of evidence and a clinical trial-focused, cost-effectiveness evaluation perspective, they represent a methodologic dead end in a number of important respects. The systems-based approach, on the other hand, with its emphasis on validation of claims and the need to consider a range of drug-impact and risk-management scenarios, offers an analytic framework that, while possibly less rigorous, is likely to contribute significantly to the management of health care systems.

Australia↗

PubMed2003

[Commentary note on the Italian translation of the Council for International Organizations of Medical Sciences 2002 Guidelines].

The new CIOMS International Ethical Guidelines on Biomedical Research Involving Human Subjects were published in August 2002. The aim of the present paper was to prepare a reasoned Italian translation of the guidelines. A preliminary version was submitted to a group of bioethicists and scientific research experts. Besides verifying the correctness and the adherence of the Italian version to the original text, a number of problematic terms were analysed. Some uncertainties emerged about the translation of expressions such as "ethical review committee" and "sponsor" and the difficulty to distinguish between "should" and "must". In the present globalisation era the need was apparent for a new approach to produce faithful translations based on a multidisciplinary approach that takes into account specific contexts and local peculiarities, but remains respectful to the original text.

Adult↗

PubMed2006

The influence of PHARMAC's National Hospital Pharmaceutical Strategy on Quality Use of Medicines activities in New Zealand hospitals.

AIM: To determine the influence of PHARMAC's National Hospital Pharmaceutical Strategy (NHPS) on Quality Use of Medicine (QUM) activities in New Zealand hospitals. METHOD: In July 2002 and July 2004, a questionnaire-based cross-sectional survey on QUM activities was administered to chief pharmacists at all 30 New Zealand public hospitals employing a pharmacist (29 in July 2004), to examine pre and post-NHPS activity. RESULTS: Both surveys achieved a 97% response rate. A range of QUM activities were undertaken in hospitals. Overall, Drug Utilisation Reviews (DURs) significantly decreased (67 vs 42) (p<0.05), although antimicrobial guidelines and intranet formularies significantly increased (p<0.05). PHARMAC's QUM initiatives, still evolving, did not appear to positively influence QUM activity in 2002-4. In 2004, PHARMAC put their original plans to coordinate QUM activity on hold and chose to participate in the processes of the Safe and Quality use of Medicines Group (SQM). Formed in 2003 by the District Health Boards of New Zealand, SQM focused attention on anticoagulants and high-risk medicines. CONCLUSION: QUM activities, similar in both periods, were not positively influenced by PHARMAC's Strategy.

Cross-Sectional Studies↗

PubMed2000

Practices to improve antimicrobial use at 47 US hospitals: the status of the 1997 SHEA/IDSA position paper recommendations. Society for Healthcare Epidemiology of America/Infectious Diseases Society of America.

OBJECTIVE: To determine the status of programs to improve antimicrobial prescribing at select US hospitals. DESIGN: Cross-sectional survey. PARTICIPANTS AND SETTING: Pharmacy and infection control staff at all 47 hospitals participating in phase 3 of Project Intensive Care Antimicrobial Resistance Epidemiology. RESULTS: All 47 hospitals had some programs to improve antimicrobial use, but the practices reported varied considerably. All used a formulary, and 43 (91%) used it in conjunction with at least one of the other three antimicrobial-use policies evaluated: stop orders, restriction, and criteria-based clinical practice guidelines (CPGs). CPGs were reported most commonly (70%), followed by stop orders (60%) and restriction policies (40%). Although consultation with an infectious disease physician (70%) or pharmacist (66%) was commonly used to influence initial antimicrobial choice, few (40%) reported a system to measure compliance with these consultations. CONCLUSIONS: In most hospitals surveyed, practices to improve antimicrobial use, although present, were inadequate based on recommendations in a Society for Healthcare Epidemiology of America and Infectious Disease Society of America joint position paper. There is room to improve antimicrobial-use stewardship at US hospitals.

Anti-Bacterial Agents↗

PubMed2004

Issues in regulatory guidelines for data monitoring committees.

As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the standard approach to implement this responsibility for many Phase III trials. Recent draft guidelines on the operation of DMCs by the Food and Drug Administration (FDA) have raised issues that need further clarification or discussion, especially for industry sponsored trials. These include, the time when DMCs are needed, the role of the independent statistician to support the DMC, and sponsor participation at DMC meetings. This paper provides an overview of these issues, based on the discussions at the January, 2003 workshop sponsored by Duke Clinical Research Institute.

Clinical Trials Data Monitoring Committees↗

PubMed1997

Managed care guidelines for the economic evaluation of pharmaceuticals.

Foundation Health Corporation, through its National Pharmacy and Therapeutics Committee, requires all pharmaceutical manufacturers and others who wish products to be considered for formulary listing to meet evidentiary and analytical standards in their submission documentation. This article details the evidentiary and analytical standards required from those making submissions and describes the methodological basis of the guidelines. This is the first time, as far as the authors are aware, that a managed care health system in the United States has required formulary submissions not only to meet clinical and economic evaluation standards, but also to take explicit account of the perspective of the managed care group in applying these techniques. Submissions are required to take what is described as a systems impact perspective. This approach is quite different, in both evidentiary and analytical terms, from standards required by health systems in other countries and standards for the economic evaluation of pharmaceuticals proposed by expert groups in the United States.

Cost-Benefit Analysis↗

PubMed1992

An analysis of the U.S. Environmental Protection Agency neurotoxicity testing guidelines.

Few of the more than 65,000 chemicals listed in the Environmental Protection Agency (EPA) inventory have been tested for neurotoxicity. The nervous system may be especially vulnerable to toxicants because many compounds can cross the blood-brain barrier and induce irreversible damage. Additionally, the young, the elderly, and other sensitive populations may be particularly susceptible to neurotoxic injury. The EPA has developed guidelines including neurobehavioral, neuropathological, and neurochemical tests for the identification of possible neurotoxicants. In the present review, tests included in the current EPA guidelines for neurotoxicity testing are described and evaluated. The main benefit of the tests is that regulators are familiar with them, thus facilitating interpretation. Additionally, validation data on these tests are available for many known neurotoxicants. These factors make it difficult to introduce new methods that may include in vitro and other techniques. The current in vivo tests can be costly and prolonged and can involve the use of many laboratory animals, making them inappropriate for generalized use on existing chemicals. It is suggested that alternative tests be incorporated for screening of large numbers of chemicals and that testing priority be given to chemicals on the basis of structure/activity relationships, lipophilicity, bioaccumulation, and extent of exposure.

Animals↗