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PubMed2005

Inclusion criteria for clinical trials in sepsis: did the American College of Chest Physicians/Society of Critical Care Medicine consensus conference definitions of sepsis have an impact?

BACKGROUND: Over the last 25 years, a growing number of clinical trials have evaluated novel sepsis therapies. To promote uniformity in inclusion criteria for patient enrollment, the American College of Chest Physicians and Society of Critical Care Medicine first published consensus conference definitions for sepsis in 1992. STUDY OBJECTIVES: To characterize (1) the utilization of specific criteria for patient enrollment in sepsis clinical trials and (2) the impact that the consensus conference definitions have had on these criteria. DESIGN: We used MEDLINE to identify clinical trials in sepsis from 1976 to 2001. Clinical trials published after the consensus conference (ACC; from 1993 to 2001) were compared with trials published before the consensus conference (BCC; from 1976 to 1992). RESULTS: We identified 176 clinical trials (ACC, 119 trials; BCC, 57 trials). Clinical trials published ACC were more likely to utilize or reference a previously published standard for inclusion criteria (65% vs 11%, respectively; p < 0.001). The consensus conference definitions were the standards used in 69% of these trials. The utilization of specified values for WBC count, temperature (T), heart rate (HR), and respiratory rate (RR) was significantly increased in the ACC group compared to the BCC group, as follows: WBC count, 62% vs 26%, respectively (p < 0.001); T, 89% vs 56%, respectively (p < 0.001); HR, 77% vs 26%, respectively (p < 0.001); and RR, respectively 76% vs 28% (p < 0.001). ACC, clinical trials were less likely to require blood culture positivity (4 of 119 trials [3%] vs 9 of 57 trials [16%], respectively; p < 0.006) and were more likely to incorporate markers of acute organ dysfunction (81 of 119 trials [68%] vs 28 of 57 trials [49%], respectively; p < 0.03) in the inclusion criteria. CONCLUSIONS: (1) Since 1992 there has been a significant increase in the utilization of predefined sepsis criteria for patient enrollment in clinical trials, and this increase can be attributed to the existence of consensus conference definitions. (2) Compared to inclusion criteria BCC, inclusion criteria ACC were less reliant on blood culture positivity and were more likely to incorporate markers of organ dysfunction.

Clinical Trials as Topic↗
PubMed2001

New developments in the prevention and treatment of venous thromboembolism.

Although unfractionated heparin has been widely used for preventing and treating venous thromboembolism, low-molecular-weight heparins (LMWHs) have been extensively studied. In particular, LMWHs have been valuable in the prevention of venous thromboembolism in high-risk surgical patients, such as those undergoing total joint replacement, and in high-risk medical patients. Recent studies indicated that the extended use of LMWHs after discharge in patients undergoing total hip replacement significantly decreases the frequency of venous thrombosis compared with placebo. Furthermore, LMWHs have been shown to be as effective and safe as unfractionated heparin for the initial treatment of both deep vein thrombosis and pulmonary embolism and have extended the treatment of these conditions into the outpatient setting. New recommendations from the sixth American College of Chest Physicians Consensus Conference on Antithrombotic Therapy and the rationale for change are discussed.

Arthroplasty, Replacement, Hip↗
PubMed2002

Adjuvant therapy for breast cancer: recommendations for management based on consensus review and recent clinical trials.

Determining the optimal individual adjuvant systemic therapy for breast cancer patients is a challenging undertaking because it requires translating data from clinical trials that have involved thousands of patients into a highly individualized, risk-adjusted approach for the patient at hand. Choosing adjuvant therapy for women with breast cancer includes consideration of four issues: A) evaluation of risk of relapse; B) extrapolation of results from clinical trials; C) therapeutic ratio, and D) the patient's preferences following a thorough discussion with her physician. Data from recently completed phase III adjuvant trials and worldwide consensus conferences document the benefits of adjuvant therapy in improving disease-free survival and overall survival for patients diagnosed with invasive breast cancer >1.0 cm in size. The benefits of hormonal therapy are clear, but limited to patients with estrogen receptor-positive breast cancer. Anthracyclines lead to improved outcomes compared with nonanthracycline regimens. Taxanes appear to improve disease-free survival in patients with node-positive disease, although longer follow-up is required to assess their impact on overall survival. Some countries have reported a reduction in the mortality rate from breast cancer over the past several years. The improved survival rate is due, at least in part, to the use of adjuvant systemic therapy. Ongoing studies are evaluating targeted therapies, with the potential of remarkably improving patient outcome.

Antineoplastic Agents, Hormonal↗
PubMed1999

Medication treatment for the severely and persistently mentally ill: the Texas Medication Algorithm Project.

This article provides an overview of the issues involved in developing, using, and evaluating specific medication guidelines for patients with psychiatric disorders. The potential advantages and disadvantages, as well as the essential elements in the structure of algorithms, are illustrated by experience to date with the Texas Medication Algorithm Project, a public-academic collaboration. Phase 1 entailed assembling research findings on the efficacy of medications for schizophrenic, bipolar, and major depressive disorders. This knowledge was evaluated for its quality and relevance, integrated with expert clinical judgment as well as input by practicing clinicians, family advocates, and patients. Phase 1 (the design and development of the algorithms) was followed by a feasibility test (Phase 2). Phase 3 is an ongoing evaluation comparing the clinical and economic effects of using specific medication guidelines (algorithms) versus treatment as usual in public sector patients with severe and persistent mental illnesses.

Algorithms↗
PubMed2001

Acupuncture: searching for benefits.

(1) Acupuncture has been assessed in hundreds of published comparative trials involving thousands of patients in a variety of situations. (2) Most of these trials are handicapped by their poor methodological quality. (3) Systematic reviews have found evidence of specific benefit in the treatment of nausea and vomiting, both postoperatively and during pregnancy. Unfortunately, the practical implications of these results are limited, notably because various methods were used to stimulate the relevant acupuncture points (needle insertion, finger pressure, electrical stimulation). (4) In other clinical uses it is either impossible to draw conclusions, or the conclusions are negative. Acupuncture should be assessed more rigorously as an analgesic method, especially in the treatment of recurrent headache, neck pain, and dental care. (5) The complications of acupuncture, although infrequent, cannot be overlooked, as they can be severe (especially infections and pneumothorax). Most of these risks might be avoided by the use of more rigorous techniques.

Acupuncture Therapy↗
PubMed2006

Antidepressant discontinuation syndrome: consensus panel recommendations for clinical management and additional research.

OBJECTIVE: Currently, no evidence-based guidelines exist for the management of serotonin reuptake inhibitor (SRI) discontinuation syndrome. This article summarizes recommendations with respect to future research as well as clinical management recommendations for SRI discontinuation syndrome. PARTICIPANTS: In April 2004, a panel of physicians convened in New York City to discuss recommendations for clinical management of and additional research on SRI discontinuation syndrome. EVIDENCE: Previous guidance for management of SRI discontinuation syndrome was proposed in 1997 in a consensus meeting also chaired by Alan F. Schatzberg. A literature search of the PubMed database was conducted to identify articles on SRI discontinuation syndrome that have been published since 1997. CONSENSUS PROCESS: The 2004 panel reviewed important preclinical and clinical studies, discussed prospective investigation of this syndrome in clinical trials, and suggested the establishment of a research network to collect data in naturalistic settings. The panel also reviewed the management recommendations published in 1997 and subsequently updated the recommendations, taking into account the latest clinical data as well as the personal experience of its members with patients. CONCLUSIONS: Additional preclinical and clinical studies are necessary to further elucidate the underlying biological mechanisms of SRI discontinuation syndrome and to identify the patient populations and agents that are most affected by this phenomenon. Management strategies include gradual tapering of doses and should emphasize clinical monitoring and patient education.

Antidepressive Agents↗
PubMed1995

[Consensus and new development in epithelial ovarian cancer chemotherapy in 1995].

Recent clinical trials have confirmed that cisplatinum combination has advantages for advanced ovarian cancer interns of response rate, response duration and disease-free time, but little advantage for overall survival. Although addition of doxorubicin to cisplatin-based chemotherapy is a matter of controversy between European countries and the USA, high-dose epirubicin, which is an analog of doxorubicin, has a potent response in relapsed cases after CDDP combination chemotherapy. Clinical trails of epirubicin + CPA + CDDP for advanced ovarian cancer and underway in Japan. Under standard supportive care, escalated CDDP dose may prolong median survival time, but its advantage for long-time survival is questionable. Trials of high-dose chemotherapy as front line treatment for advanced ovarian cancer supported by PBSCT/G-CSF in combination with assessment of scheduled AUC have been collected from many world-wide institutes. GOG demonstrated that intraperitoneal administration of CDDP with intravenous CPA had obvious superiority to intravenous CDDP and CPA in overall survival and adverse effect for stage III ovarian cancer, under the conditions that 70% of cases had minimum residual tumor (< 0.5 cm). We have to make sure whether this modality has the same effect on early and stage IV ovarian cancer. Taxol plus CDDP has promising benefits for median disease free survival and median survival time, so it is becoming the standard regimen for advanced ovarian cancer in USA. The delay of the clinical introduction of taxanes should be eliminated promptly in Japan.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1995

Evidence-based periodontal treatment. II. Predictable regeneration treatment.

Clinical experience, technical ability, and intuition are indispensable but are no longer sufficient as the sole clinical skills necessary to provide the best outcomes from periodontal and peri-implant regeneration treatment. This article describes a comprehensive and rigorous methodologic framework to assess the available evidence contained within the literature. This assessment tool is referred to as the evidence-based method. The methodology was used by a series of task forces convened to evaluate three common areas of clinical regenerative treatment. The major goals of these task forces were: (1) to increase the strength of the inference that practitioners can derive from the base of knowledge contained within the literature, (2) to develop algorithms to improve the predictability of regeneration treatment, and (3) to determine methods that can be used to predictably transfer the value of therapy to the patient.

Algorithms↗
PubMed1996

Impact and interpretation of multiple guidelines and consensus documents.

The US National High Blood Pressure Education Program (NHBPEP) was established in 1972, shortly after publication of the initial landmark reports of the Veterans Administration Cooperative study reports demonstrating safety and efficacy in reducing abnormally elevated arterial pressure with antihypertensive drugs. Over the ensuing 23 years, this program was responsible for the formulation of periodic guidelines on the general approach to the patient with hypertension as well as on a number of more specific considerations by more specialized working groups that deal with other concerns relative to the diagnosis, treatment and other aspects of hypertensive cardiovascular disease.

Clinical Trials as Topic↗