On the Evaluation of Treatments for Narcotics Addiction

1979 ◽  
Vol 9 (2) ◽  
pp. 205-211 ◽  
Author(s):  
Vincent P. Dole ◽  
Burton Singer
Keyword(s):  
Clinical Trials ◽  
Randomized Trial ◽  
Observational Data ◽  
Chronic Diseases ◽  
Drug Addiction ◽  
Randomized Trials ◽  
Randomized Clinical Trials ◽  
The Other ◽  
Domain Of Applicability

This study is concerned with the domain of applicability of randomized clinical trials. For evaluation of well-defined treatments of acute diseases over limited periods of time, the randomized trial technique is unquestionably the best. However, in the field of chronic diseases (as illustrated by drug addiction) the physician's responsibility extends over periods of years, and his judgements involve consideration of many contingent factors which vary in the course of the disease. In this domain, randomized clinical trials, however ambitious in design, give only partial guidance. Observational data therefore must be used if treatment is to be optimized for individual patients. Two randomized trials in the treatment of narcotics addiction — one testing methadone and the other naltrexone — are reviewed, with comments on their conclusions and limitations.

scholarly journals Acupuncture for Managing Cancer-Related Insomnia: A Systematic Review of Randomized Clinical Trials

2016 ◽  
Vol 16 (2) ◽  
pp. 135-146 ◽  
Author(s):  
Tae-Young Choi ◽  
Jong In Kim ◽  
Hyun-Ja Lim ◽  
Myeong Soo Lee
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Sleep Quality ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Sham Acupuncture ◽  
Risk Of Bias ◽  
The Other ◽  
Level Of Evidence

Background. Insomnia is a prominent complaint of cancer patients that can significantly affect their quality of life and symptoms related to sleep quality. Conventional drug approaches have a low rate of success in alleviating those suffering insomnia. The aim of this systematic review was to assess the efficacy of acupuncture in the management of cancer-related insomnia. Methods. A total of 12 databases were searched from their inception through January 2016 without language restriction. Randomized controlled trials (RCTs) and quasi-RCTs were included if acupuncture was used as the sole intervention or as an adjunct to another standard treatment for any cancer-related insomnia. The data extraction and the risk of bias assessments were performed by 2 independent reviewers. Results. Of the 90 studies screened, 6 RCTs were included. The risk of bias was generally unclear or low. Three RCTs showed equivalent effects on the Pittsburgh Sleep Quality Index and 2 RCTs showed the similar effects on response rate to those of conventional drugs at the end of treatment. The other RCT showed acupuncture was better than hormone therapy in the numbers of hours slept each night and number of times woken up each night. The 3 weeks of follow-up in 2 RCTs showed superior effects of acupuncture compared with conventional drugs, and a meta-analysis showed significant effects of acupuncture. Two RCTs tested the effects of acupuncture on cancer-related insomnia compared with sham acupuncture. One RCT showed favourable effects, while the other trial failed to do so. Conclusion. There is a low level of evidence that acupuncture may be superior to sham acupuncture, drugs or hormones therapy. However, the number of studies and effect size are small for clinical significance. Further clinical trials are warranted.

Predictors of Cognitive Improvement Following Treatment for Late-Life Depression

2020 ◽  
pp. 089198872091551
Author(s):  
Prabha Siddarth ◽  
Cynthia M. Funes ◽  
Kelsey T. Laird ◽  
Linda Ercoli ◽  
Helen Lavretsky
Keyword(s):  
Clinical Trials ◽  
Standard Deviation ◽  
Social Functioning ◽  
Randomized Clinical Trials ◽  
Antidepressant Treatment ◽  
Late Life ◽  
The Other ◽  
Late Life Depression ◽  
Cognitive Improvement ◽  
Severity Of Depression

Objective: Cognitive impairment is frequently comorbid with late-life depression (LLD) and often persists despite remission of mood symptoms with antidepressant treatment. Increasing understanding of factors that predict improvement of cognitive symptoms in LLD is useful to inform treatment recommendations. Methods: We used data from 2 randomized clinical trials of geriatric depression to examine the relationships between sociodemographic factors (resilience, quality of life) and clinical factors (age of depression onset, severity of depression, apathy) with subsequent cognitive outcomes. One hundred sixty-five older adults with major depression who had completed one of 2 clinical trials were included: (1) methylphenidate plus placebo, citalopram plus placebo, and citalopram plus methylphenidate or (2) citalopram combined with Tai Chi or health education. A comprehensive neuropsychiatric battery was administered; 2 measures of cognitive improvement were examined, one defined as an increase in general cognitive performance score of at least 1 standard deviation and the other 0.5 standard deviation pre–post treatment. Results: At posttreatment, 59% of participants had remitted, but less than a third of those who remitted showed cognitive improvement (29%). Cognitive improvement was observed in 18% of nonremitters. Lower baseline depression severity, greater social functioning, and depression onset prior to 60 years of age were significantly associated with cognitive improvement. None of the other measures, including baseline apathy, resilience, and depression remission status, were significantly associated with cognitive improvement. Conclusions: Lower severity of depression, earlier onset, and greater social functioning may predict improvement in cognitive functioning with treatment for depression in LLD.

Carotid artery stenting: A systematic review of randomized clinical trials

VASA ◽  
2009 ◽  
Vol 38 (4) ◽  
pp. 281-291 ◽  
Author(s):  
Knur
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Carotid Artery ◽  
Carotid Artery Stenting ◽  
Randomized Trials ◽  
Randomized Clinical Trials ◽  
Low Risk ◽  
Carotid Surgery ◽  
Risk Patients ◽  
Carotid Occlusive Disease

Carotid occlusive disease is responsible for a significant proportion of major adverse cardiovascular events (death, stroke, myocardial infarction). Effective prevention by means of revascularization is a sufficient treatment, if performed at a center with an acceptably low procedural complication rate. Carotid surgery is the currently accepted standard of treatment for revascularization of extra cranial carotid occlusive disease. This has been validated by randomized clinical trials that have demonstrated its efficacy over best medical therapy. However, less invasive protected carotid artery stenting (CAS) has emerged as a potential therapeutic alternative to carotid endarterectomy (CEA) for the treatment of carotid atherosclerotic disease. Over the past decade several clinical trials have compared endovascular with surgical treatment. The Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial favored stenting over surgery in high-risk patients. The effectiveness of endovascular treatment in low-risk patients and patients with asymptomatic stenoses at preventing of stroke is still uncertain. Carotid artery stenting with an embolic protection device cannot be considered a scientifically sound and evidence-based alternative to carotid surgery in low-risk and asymptomatic patients until we have the results of further randomized trials. This overview presents the currently available data from randomized trials.

scholarly journals Incidental genetic findings in randomized clinical trials: recommendations from the Genomics and Randomized Trials Network (GARNET)

10.1186/gm411 ◽  
2013 ◽  
Vol 5 (1) ◽  
pp. 7 ◽  
Author(s):  
Ebony B Bookman ◽  
Corina Din-Lovinescu ◽  
Bradford B Worrall ◽  
Teri A Manolio ◽  
Siiri N Bennett ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Trials ◽  
Randomized Clinical Trials

A Randomized Trial Assessing the Impact of Written Information on Outpatients' Knowledge About and Attitude Toward Randomized Clinical Trials

2000 ◽  
Vol 21 (3) ◽  
pp. 223-240 ◽  
Author(s):  
Alexandra Y. Kruse ◽  
Lise L. Kjaergard ◽  
Kim Krogsgaard ◽  
Christian Gluud ◽  
Erik L. Mortensen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Trial ◽  
Randomized Clinical Trials ◽  
Written Information ◽  
The Impact

Infections in cancer patients treated with immune checkpoint inhibitors: Data from randomized trials.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2637-2637
Author(s):  
Cinzia Solinas ◽  
Anna Maria Morelli ◽  
Andrea Luciani ◽  
Antonio Ghidini ◽  
Fausto Petrelli
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Solid Tumors ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Randomized Trials ◽  
Randomized Clinical Trials ◽  
Checkpoint Inhibitors ◽  
Cochrane Library ◽  
And Control

2637 Background: Febrile neutropenia and infections are well studied complications of chemotherapy (CT) and some targeted agents employed in oncology. Less is known about the risk of infection associated with the use of immune checkpoint inhibitors (ICIs) in cancer patients. The present systematic review and meta-analysis was performed to address this question in patients diagnosed with solid tumors enrolled in randomized trials employing ICIs as experimental treatment. Methods: The Cochrane Library, EMBASE, and Pubmed databases were searched from inception through December 1st, 2020. Randomized clinical trials comparing any ICI alone, with CT, or with other agents vs CT, placebo, or other agents in patients with solid tumors were included. Two independent reviewers used a standardized data extraction and quality assessment form. Discordant cases were discussed with a third independent investigator. The following information was extracted: baseline study characteristics, including the primary tumor, author, year of publication, type of trial, type of disease, and the type of therapy (experimental and control arms); and the incidence of any-grade (grades [G] 1–5), low-grade (G1–2), and high-grade (G3–4), fatal event (G5) infections, and type of event. Random or fixed-effect models were used according to the statistical heterogeneity. Results: 36 randomized clinical trials were deemed eligible. The total population reached 21451 patients. In the pooled analysis, the use of ICIs was associated with a similar risk of all-grade infections (relative risk, RR = 1.02; 95% CI 0.84–1.24; P = 0.85) compared to non-ICI treatments (G1-5 events: 9.6 vs. 8.3%). When the ICIs alone arms were compared to CT, the experimental arms were associated with a 42% less risk of all-grade infections (RR = 0.58, 95% CI 0.4–0.85; P = 0.01; N = 18 studies). Compared to CT, the combination of ICIs and CT increased the risk of all-grade infections (RR = 1.37, 95% CI 1.23–1.53; P < 0.01; N = 13 studies) and severe infections (RR = 1.52, 95% CI 1.17–1.96; P < 0.01; N = 12 studies). Fatal infections were similar in the experimental and control arms (0.5%). Conclusions: In patients with advanced solid tumors, when ICIs were administered with CT, the risk of all-grade and G3-5 infections was significantly increased. Compared to CT alone, ICIs were safer and their use should be recommended for frail patients. Further studies are required to identify high-risk patients and evaluate the need for CT dose reduction or prophylactic myeloid growth factors use.

Propensity score matching versus coarsened exact matching in observational comparative effectiveness research

2021 ◽  
Author(s):  
David Guy ◽  
Igor Karp ◽  
Piotr Wilk ◽  
Joseph Chin ◽  
George Rodrigues
Keyword(s):  
Clinical Trials ◽  
Propensity Score ◽  
Propensity Score Matching ◽  
Observational Data ◽  
Randomized Clinical Trials ◽  
Original Data ◽  
Considerable Proportion ◽  
Exact Matching ◽  
Coarsened Exact Matching ◽  
Comparison Groups

Aim & methods: We compared propensity score matching (PSM) and coarsened exact matching (CEM) in balancing baseline characteristics between treatment groups using observational data obtained from a pan-Canadian prostate cancer radiotherapy database. Changes in effect estimates were evaluated as a function of improvements in balance, using results from randomized clinical trials to guide interpretation. Results: CEM and PSM improved balance between groups in both comparisons, while retaining the majority of original data. Improvements in balance were associated with effect estimates closer to those obtained in randomized clinical trials. Conclusion: CEM and PSM led to substantial improvements in balance between comparison groups, while retaining a considerable proportion of original data. This could lead to improved accuracy in effect estimates obtained using observational data in a variety of clinical situations.

scholarly journals Monitoring for Lack of Benefit: A Critical Component of a Randomized Clinical Trial

2009 ◽  
Vol 27 (4) ◽  
pp. 629-633 ◽  
Author(s):  
Boris Freidlin ◽  
Edward L. Korn
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Beneficial Effect ◽  
Randomized Clinical Trials ◽  
The Other ◽  
Data Monitoring ◽  
Complex Nature ◽  
Critical Component ◽  
Efficacy Data ◽  
Aggressive Approach

To balance patient interests against the need for acquiring evidence, ongoing randomized clinical trials are formally monitored for early convincing indication of benefit or lack of benefit. In lethal diseases like cancer, where new therapies are often toxic and may have limited preliminary efficacy data, monitoring for lack of benefit is particularly important. We review the complex nature of stopping a randomized trial for lack of benefit and argue that many cancer trials could be improved by a more aggressive approach to monitoring. On the other hand, we caution that some commonly used monitoring guidelines may result in stopping for lack of benefit even when a nontrivial beneficial effect is observed.

Evaluating Mortality with Erythropoietic Stimulating Agents (ESAs) in the Nephrology Setting: The Distinction between Evaluating Trials That Measure Survival as a Primary or Secondary Efficacy Endpoint Versus a Safety Endpoint.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 962-962
Author(s):  
Sara E. Barnato ◽  
Charles L. Bennett ◽  
Kathleen Elverman ◽  
Dennis P. West ◽  
Mark Courtney
Keyword(s):  
Clinical Trials ◽  
Relative Risk ◽  
Randomized Trials ◽  
Randomized Clinical Trials ◽  
Outcome Measure ◽  
Meta Analysis ◽  
Safety Measure ◽  
Significant Safety ◽  
Randomized Controlled ◽  
Efficacy Outcome

Abstract Background: At ASCO 2007, we reported increased mortality risks when ESAs are administered to anemic cancer patients who are receiving chemotherapy when target hemoglobin levels are beyond the correction of anemia. In February 2007, a meta-analysis of nine randomized clinical trials with 5,143 patients published in the Lancet [vol 369; 381–88] identified a statistically significant risk of all cause mortality (relative risk (RR) of 1.17, 95% confidence interval (CI) 1.01, 1.35) when anemic patients with chronic kidney disease received ESAs targeted to higher hemoglobin concentrations (120–150 g/L). A recent report from the RADAR (Research against Adverse Drug Reactions) group raises concern that survival analyses might differ depending on whether survival was evaluated as a measure of efficacy versus a measure of safety. Herein, we re-analyze the data by evaluating randomized clinical trials according to whether or not survival was prospectively included as a primary or secondary efficacy outcome. Methods: Risks of death in randomized controlled clinical trials included in the Lancet meta-analysis were evaluated. We classified those studies based on their mortality outcomes, either as an efficacy outcome or as a safety outcome. Effect estimates for RR and 95% CI were derived from Stata (version 9.1, College Station, TX), calculated with random-effects models and pooled by use of the Dersimonian and Laird method. Results: In studies where survival was measured as an efficacy endpoint, the relative risk of mortality with ESAs targeted to higher hemoglobin levels was 1.27 (1.08, 1.49), a number greater than the relative risk reported in the Lancet meta-analysis. Conclusions: Randomized controlled trials should be included in meta-analyses that evaluate harms only if the relevant safety measure is prospectively included as a primary or secondary efficacy outcome measure in the study protocol. When survival was included as part of the efficacy analysis, a statistically significant safety signal was present. Randomized trials that included harms as a measure of safety did not present a statistically significant safety signal. Including randomized trials that include harms as a safety measure introduce noise and can mask safety signals. Studies: Events: RR (95% CI) Survival included as a primary or secondary efficacy outcome measure: High vs Low Hb Target: Besarab 1998 (n=1233) 183/618 vs 150/615 1.21 (1.01, 1.46) Gouva 2004 (n=88) 4/43 vs 3/45 1.40 (0.33, 5.87) Drueke 2006 (n=602) 31/300 vs 21/302 1.49 (0.87, 2.53) Singh 2006 (n=1432) 52/715 vs 36/717 1.45 (0.96, 2.19) Subtotal (n=3355) 270/1676 vs 210/1679 1.27 (1.08, 1.49) Survival included only as a safety measure: High vs Low Hb Target: Foley 2000 (n=146) 4/73 vs 3/73 1.33 (0.31, 5.75) Furuland 2003 (n=416) 29/216 vs 27/200 0.99 (0.61, 1.62) Roger 2005 (n=154) 0/75 vs 0/79 not estimable Levin 2005 (n=152) 1/74 vs 3/78 0.35 (0.04, 3.30) Parfrey 2005 (n=696) 12/396 vs 20/300 0.45 (0.23, 0.92) Rossert 2006 (n=390) 1/195 vs 6/195 0.17 (0.02, 1.37) Subtotal (n=1954) 47/1029 vs 59/925 0.67 (0.37, 1.19)

Randomized Clinical Trials in Oncology: Understanding and Attitudes Predict Willingness to Participate

2001 ◽  
Vol 19 (15) ◽  
pp. 3554-3561 ◽  
Author(s):  
Peter M. Ellis ◽  
Phyllis N. Butow ◽  
Martin H.N. Tattersall ◽  
Stewart M. Dunn ◽  
Nehmat Houssami
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Trials ◽  
Randomized Clinical Trials ◽  
Screening Mammography ◽  
Diagnostic Assessment ◽  
Willingness To Participate ◽  
Cross Sectional Survey ◽  
Breast Clinic

PURPOSE: To explore the association at different time points in the trajectory of breast cancer care, between anxiety, knowledge, and attitudes, on women’s willingness to participate in randomized clinical trials. MATERIALS AND METHODS: A cross-sectional survey was undertaken among women attending a breast clinic for screening mammography or diagnostic assessment plus women with newly diagnosed breast cancer to assess attitudes toward and willingness to participate in randomized clinical trials of breast cancer treatment. RESULTS: Five hundred forty-five women completed questionnaires assessing knowledge of and attitudes toward randomized clinical trials. The mean age of respondents was 48.9 years (SD, 11.3 years). Thirty-three percent of women would consider participating in a clinical trial if they had breast cancer. Women with breast cancer (31%) were significantly more likely to decline to participate than women attending for screening mammography (15%) or diagnostic assessment (15%, P = .0002). Women who might consider participating in a randomized clinical trial were more knowledgeable about randomized trials (mean difference, 0.7; 95% confidence interval [CI], 0.2 to 1.2; P = .003). In a multivariate analysis, women who would consider participating in a randomized trial were younger (odds ratio [OR], 0.96; 95% CI, 0.93 to 0.99), more likely to want an active role in decision-making (OR, 3.2; 95% CI, 1.3 to 7.6), and reported a greater impact from the positive aspects of clinical trials (OR, 2.2; 95% CI, 1.3 to 3.8) and less impact from the negative aspects of clinical trials (OR, 2.2; 95% CI, 1.3 to 3.2). CONCLUSION: These findings suggest that women who have a better understanding of issues about clinical trials have more favorable attitudes toward randomized trials and are more willing to consider participation in a clinical trial.

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