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PubMed1994

Standardized assessment for panic disorder research. A conference report.

Lively controversies related to panic disorder are under active investigation by research groups around the world. However, publications from different laboratories are difficult to compare since there has been little consistency in measures or even in types of assessment used to characterize and follow up patients. Participants in the recently convened National Institutes of Health Consensus Development Conference on the Treatment of Panic Disorder noted this problem and recommended establishment of procedures to ensure comparability of studies. We organized a conference of clinical investigators whose objective was to develop a standard assessment package. Participants represented biological and psychosocial panic disorder treatment research sites in the United States and Canada. The 2-day conference resulted in agreement on a battery of assessments considered essential for panic disorder studies. The purposes of our report are to disseminate the conference conclusions and to encourage adoption of the proposed standards by clinical researchers, journal editors, Public Health Service peer review committees, and the Food and Drug Administration. We also identify some problematic issues that require further work.

Follow-Up Studies↗
PubMed2002

National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders.

A consensus conference on the use of placebo in mood disorder studies consisted of expert presentations on bioethics, biostatistics, unipolar depression, and bipolar disorder. Work groups considered evidence and presented statements to the group. Although it was not possible to write a document for which there was complete agreement on all issues, the final document incorporated input from all authors. There was consensus that placebo has a definite role in mood disorder studies. Findings of equivalence between a new drug and standard treatment in active control studies is not evidence of efficacy unless the new drug is also significantly more effective than placebo. Add-on studies in which patients are randomized to standard therapy plus the investigational drug or standard therapy plus placebo are especially indicated for high-risk patients. Mood disorders in elderly and pediatric patients are understudied, and properly designed trials are urgently needed. Research is needed on the ethical conduct of studies to limit risks of medication-free intervals and facilitate poststudy treatment. Patients must fully understand the risks and lack of individualized treatment involved in research.

Bipolar Disorder↗
PubMed2003

Depression and Bipolar Support Alliance consensus statement on the unmet needs in diagnosis and treatment of mood disorders in late life.

OBJECTIVES: To review progress made during the past decade in late-life mood disorders and to identify areas of unmet need in health care delivery and research. PARTICIPANTS: The Consensus Development Panel consisted of experts in late-life mood disorders, geriatrics, primary care, mental health and aging policy research, and advocacy. EVIDENCE: (1) Literature reviews addressing risk factors, prevention, diagnosis, treatment, and delivery of services and (2) opinions and experiences of primary care and mental health care providers, policy analysts, and advocates. CONSENSUS PROCESS: The Consensus Development Panel listened to presentations and participated in discussions. Workgroups considered the evidence and prepared preliminary statements. Workgroup leaders presented drafts for discussion by the Consensus Development Panel. The final document was reviewed and edited to incorporate input from the entire Consensus Development Panel. CONCLUSIONS: Despite the availability of safe and efficacious treatments, mood disorders remain a significant health care issue for the elderly and are associated with disability, functional decline, diminished quality of life, mortality from comorbid medical conditions or suicide, demands on caregivers, and increased service utilization. Discriminatory coverage and reimbursement policies for mental health care are a challenge for the elderly, especially those with modest incomes, and for clinicians. Minorities are particularly underserved. Access to mental health care services for most elderly individuals is inadequate, and coordination of services is lacking. There is an immediate need for collaboration among patients, families, researchers, clinicians, governmental agencies, and third-party payers to improve diagnosis, treatment, and delivery of services for elderly persons with mood disorders.

Age Factors↗
PubMed2002

The 2001 Bethesda System: terminology for reporting results of cervical cytology.

OBJECTIVES: The Bethesda 2001 Workshop was convened to evaluate and update the 1991 Bethesda System terminology for reporting the results of cervical cytology. A primary objective was to develop a new approach to broaden participation in the consensus process. PARTICIPANTS: Forum groups composed of 6 to 10 individuals were responsible for developing recommendations for discussion at the workshop. Each forum group included at least 1 cytopathologist, cytotechnologist, clinician, and international representative to ensure a broad range of views and interests. More than 400 cytopathologists, cytotechnologists, histopathologists, family practitioners, gynecologists, public health physicians, epidemiologists, patient advocates, and attorneys participated in the workshop, which was convened by the National Cancer Institute and cosponsored by 44 professional societies. More than 20 countries were represented. EVIDENCE: Literature review, expert opinion, and input from an Internet bulletin board were all considered in developing recommendations. The strength of evidence of the scientific data was considered of paramount importance. CONSENSUS PROCESS: Bethesda 2001 was a year-long iterative review process. An Internet bulletin board was used for discussion of issues and drafts of recommendations. More than 1000 comments were posted to the bulletin board over the course of 6 months. The Bethesda Workshop, held April 30-May 2, 2001, was open to the public. Postworkshop recommendations were posted on the bulletin board for a last round of critical review prior to finalizing the terminology. CONCLUSIONS: Bethesda 2001 was developed with broad participation in the consensus process. The 2001 Bethesda System terminology reflects important advances in biological understanding of cervical neoplasia and cervical screening technology.

Female↗
PubMed1997

Therapy of hepatitis C: overview.

Based on the first decade of research on alpha interferon in viral hepatitis, one can conclude that up to 40% of patients with compensated chronic hepatitis C and elevated alanine aminotransferase (ALT) levels will respond at least transiently to interferon. Four forms of alpha interferon have been evaluated in large numbers of patients with chronic hepatitis C: alfa-2b, alfa-2a, alfa-n1, and consensus interferon (CIFN). Responses are defined on the basis of biochemical (ALT) or virological (hepatitis C virus [HCV] RNA testing by polymerase chain reaction [PCR]) end points, and as end-of-treatment response (ETR) or sustained response (SR). Biochemical ETR rates to 6 months of therapy range from 35% to 50%, and SR rates 6 months after treatment from 8% to 21%. Although 6-month treatment courses are associated with a significant rate of relapse, 12 months of initial treatment and re-treatment regimens markedly improve the SR rate. Long-term follow-up evaluation in patients with an SR to interferon consistently show long-lasting and significant clinical, virological, and histological improvement. Finally, baseline factors that have been shown to be associated with SR to 6 months of treatment are not accurate enough to predict response. Therefore, the best treatment strategy is a therapeutic trial. Further studies of interferon therapy of hepatitis C are needed to define better virological end points useful in stopping therapy, to understand and better manage significant side effects of interferon, and to evaluate the histological effects of interferon in biochemical nonresponders. Also needed is a better understanding of the causes of resistance to interferon. Finally, newer therapeutic regimens such as the use of induction therapy and combination therapies with ribavirin, other antiviral agents, cytokines, and cytokine modifiers are of primary importance in eventually developing safe and effective means of treatment of hepatitis C.

Antiviral Agents↗
PubMed1997

Management of hepatitis C: a national survey of gastroenterologists and hepatologists.

A survey on the management of hepatitis C virus (HCV) infection was conducted by the American Digestive Health Foundation among United States physicians who are most familiar with the disease. The two-page survey was completed by 57% of a random sample of 2,500 members of the American Gastroenterological Association and the American Association for the Study of Liver Diseases. Analysis was limited to the 1,249 responses from physicians who spent at least 1 day per week in patient care. These physicians frequently managed patients with HCV, and nearly three quarters treated patients with interferon. To prevent transmission, the large majority of physicians recommended measures to avoid blood exposures, were uncertain or disagreed about the importance of sexual contact, and did not caution patients about casual contact. More than 70% of physicians told their patients to stop or minimize alcohol consumption. In the management of a patient with antibody to HCV but normal serum aminotransferase activities, 87% of physicians would have ordered a supplemental test, and if HCV were confirmed, 46% would have obtained a liver biopsy, but only 15% would have treated the patient with interferon. For a patient with chronic HCV infection and elevated serum aminotransferase activities, more than 90% of physicians would have obtained a liver biopsy and approximately 60% would have treated with interferon. Physicians who are most familiar with the management of patients with HCV generally agreed with the recommendations of the Consensus Development Conference Panel regarding prevention of transmission, minimizing alcohol consumption, and managing patients with typical presentations. Controversies remain regarding some issues of general management, the value of molecular testing, and the need to treat certain patients with interferon.

Gastroenterology↗
PubMed1997

Therapy of hepatitis C: interferon alfa-n1 trials.

Interferon alfa-n1 is produced from a lymphoid cell line and consists of multiple alpha interferon subtypes. Early studies indicated that interferon alfa-n1 was effective against hepatitis C, and a meta-analysis of published trials indicated that it was equally likely as recombinant alpha interferons to produce an end-of-treatment biochemical and histological response. However, there appeared to be a lower rate of posttreatment relapse after a 6-month course of interferon alfa-n1, so that the sustained response rate was 25% compared with 16% for recombinant alpha interferons. Subsequently, the efficacy of interferon alfa-n1 has been compared with recombinant alpha interferon directly in two large multicenter studies. The 096 International Hepatitis Comparative Study compared alfa-n1 with interferon alfa-2b in doses of 3 million units (MU) three times weekly for 24 weeks in a total of 1,071 patients. Biochemical end-of-treatment response rates were similar (35% for alfa-n1; 38% for alfa-2b), as were virological and histological responses. Relapse occurred more frequently after interferon alfa-2b, so that sustained biochemical (10.3% vs. 6.7%) and virological responses at 12 months were higher for alfa-n1. In a second study from Italy, interferon alfa-n1 was compared with interferon alfa-2a, using higher doses (6 MU three times weekly) until a biochemical response was obtained, and then using 3 MU three times weekly for a total of 12 months. The combined biochemical and virological sustained response rates were higher than reported with 6 months of treatment and were similar for alfa-n1 (17%) as for alfa-2a (16%). The superiority of 12 versus 6 months of treatment was also confirmed in the large multicenter 091 European Comparative Treatment Schedules study of 440 patients given four different regimens of therapy. Sustained biochemical response rates were 6% in patients who received 3 MU three times weekly for 6 months and 19% in those who received this dose for 12 months. When given for 12 months, there was no advantage to a slightly higher dose of interferon alfa-n1 (5 MU three times weekly). Thus, therapy with interferon alfa-n1 produces sustained response rates equivalent to the best obtained with recombinant alpha interferon. The optimal treatment regimen appears to be 3 MU given three times weekly for 12 months.

Antiviral Agents↗
PubMed1997

Side effects of alpha interferon in chronic hepatitis C.

Alpha interferons have been used widely to treat chronic hepatitis C virus infection. These include recombinant interferons, purified natural leukocyte, and lymphoblastoid interferons. Alpha interferon is administered by subcutaneous or intramuscular injection either daily or three times weekly for a period of 6 to as long as 24 months. A wide array of adverse effects of alpha interferon have been described. Several side effects such as fever, headache fatigue, arthralgias, and myalgias are common, especially with the initial injections. These early side effects of interferon are predictable and are encountered in the majority of patients. These may not require dose modification, but can be problematic for a significant proportion of patients. Other adverse events effects may require dose modification or even discontinuation of therapy in 2% to 10% of patients. Neuropsychiatric side effects such as depression and irritability can be most troublesome; their mechanisms are not well understood. Granulocytes, platelets, and red blood cell counts decrease during treatment, but the decreases are usually mild, although they can be dose limiting if cell counts are low initially. Interferon has important immunomodulatory properties, and treatment can induce autoimmune phenomena, the most frequent being autoimmune thyroiditis with either hypothyroidism or hyperthyroidism, especially in predisposed patients. Other autoimmune disease can be aggravated by interferon therapy. Severe and even life-threatening side effects of interferon occur in 0.1% to 1% of patients; these include thyroid, visual, auditory, renal, and cardiac impairment, and pulmonary interstitial fibrosis. Some of these side effects may be irreversible. Higher doses of interferon (above 5 million units three times weekly) cause higher rates of adverse events than standard doses. Contraindications to alpha interferon have been recognized.

Antiviral Agents↗
PubMed1997

Factors predictive of a beneficial response to therapy of hepatitis C.

Alpha interferon is the only drug that has been shown to be effective in the treatment of chronic hepatitis C, but only half of patients respond, either transiently or permanently. Pretreatment features that are associated with a greater likelihood of response to short courses of interferon include low hepatitis C virus (HCV) RNA levels, viral genotypes 2 or 3, and the absence of fibrosis or cirrhosis on liver biopsy. Each of these features is more predictive of sustained response (SR) than the end-of-treatment response (ETR). However, the accuracy of these features in predicting response in individual patients is poor. Furthermore, there are several limitations to using these factors in the clinical management of patients. Most importantly, they were identified in 6-month treatment trials. Longer treatment or combination of interferon with ribavirin reduces relapses and will therefore lessen the association of these factors with long-term response. In addition, changes in the definition of treatment end points and the technology used to measure HCV RNA might change the association between these predictive factors and response. The best predictor of a treatment response is the early normalization of the serum alanine aminotransferase (ALT) level during interferon treatment. HCV RNA loss during treatment may also be helpful in predicting response, but it is probably no better than serum ALT levels and is expensive. In summary, several clinical and virological features are associated with higher response rates to interferon treatment. Although pretreatment factors do not accurately predict treatment outcome in individuals, they may be helpful in counseling patients and making treatment decisions.

Algorithms↗
PubMed1997

Therapy of hepatitis C: patients with cirrhosis.

The management of both compensated and decompensated cirrhosis caused by hepatitis C must be viewed in the context of the natural history of the disease. The prognosis of compensated cirrhosis caused by hepatitis C is relatively good. In a recent retrospective study, after 5 years of follow-up evaluation, 18% of patients had developed hepatic decompensation and 7% hepatocellular carcinoma. Overall 5-year survival rate was 91%. Treatment with alpha interferon appears to decrease the incidence of hepatocellular carcinoma in patients who achieve a sustained remission. However, on an intention-to-treat basis and after adjustment for differences in clinical and serological features at entry, interferon therapy does not correlate with a reduced incidence of liver cancer or improved survival. Combined analysis of multiple large studies on patients with cirrhosis caused by hepatitis C indicates that current regimens of alpha interferon (3 to 6 million units three times weekly for 6 to 12 months) result in a sustained biochemical response in 9% of patients. The rates of sustained virological responses are less well documented. Virological measurements during therapy show that only 22% of patients become hepatitis C virus (HCV) RNA negative by 4 weeks and, thereafter, there is a high rate of breakthrough. In small studies, the combination of interferon and ribavirin leads to sustained biochemical and virological response rates of 21%, more than twice the rates achieved with interferon alone. The prognosis of decompensated cirrhosis caused by hepatitis C is poor, with a 5-year survival rate of only 50%. The efficacy of interferon in patients with decompensated cirrhosis is not well documented and its use cannot be recommended. In contrast, 5-year survival rates after liver transplantation for cirrhosis caused by hepatitis C is excellent, in the range of 70% to 80%. Recurrence of HCV infection occurs in more than 95% of patients, but in short-term follow-up studies, recurrence of cirrhosis and graft failure occurs in only 10% of patients.

Antiviral Agents↗
PubMed1997

Therapy of hepatitis C: patients with normal aminotransferase levels.

An important group of patients with chronic hepatitis C have normal serum alanine aminotransferase (ALT) levels despite having hepatitis C virus (HCV) RNA detectable in serum. These patients are typically identified after donating blood and being found to be positive for antibody to HCV (anti-HCV). A strict definition of this patient population is needed, which should include presence of anti-HCV, HCV RNA detectable by polymerase chain reaction (PCR), and persistently normal ALT levels. These patients are usually asymptomatic, but almost all have histological evidence of chronic hepatitis on liver biopsy. The liver histological lesions are generally mild, and cirrhosis is rare. The long-term outcome of this group of patients with chronic HCV infection is not known, but the prognosis is probably good. In small, uncontrolled trials of alpha interferon in this group of patients, end-of-treatment virological responses occurred in approximately 50% and sustained responses 6 to 12 months afterwards in 20%. These rates of response are not very different from those reported in patients with abnormal ALT levels. Importantly, in most studies, serum ALT levels became abnormal during therapy in approximately half of patients, and levels remained abnormal in a proportion after therapy. These findings suggest that alpha interferon therapy is not usually beneficial and may be harmful in patients with chronic hepatitis C who have normal ALT levels, perhaps as a result of the immunomodulatory actions of alpha interferon that may alter the balance of host immune reactions and viral replication, which seem to be responsible for the liver injury in chronic hepatitis C.

Alanine Transaminase↗