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Carlos Blanco - One of the best experts on this subject based on the ideXlab platform.
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Generalizability of Pharmacologic and Psychotherapy Clinical Trial Results for Posttraumatic Stress Disorder to Community Samples
The Journal of Clinical Psychiatry, 2016Co-Authors: Silvia Franco, Nicolas Hoertel, Shuai Wang, Frédéric Limosin, Kibby Mcmahon, Jorge Mario Rodríguez-fernández, Hugo Peyre, Carlos BlancoAbstract:OBJECTIVE The present study sought to quantify the generalizability of pharmacologic and psychotherapy Clinical Trial Results in individuals with a DSM-IV diagnosis of posttraumatic stress disorder (PTSD) to a large representative community sample. METHODS Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large nationally representative sample of the adult US population. We applied a standard set of exclusion criteria representative of pharmacologic and psychotherapy Clinical Trials to all adults with a DSM-IV diagnosis of PTSD in the previous 12 months (n = 1,715) and then to a subsample of participants seeking treatment (n = 366). Our aim was to assess how many participants with PTSD would fulfill typical eligibility criteria. Results We found that more than 6 of 10 respondents from the overall PTSD sample and more than 7 of 10 respondents seeking treatment for PTSD would have been excluded by 1 exclusion criterion or more in a typical pharmacologic Trial. In contrast, about 2 of 10 participants in the full sample and about 3 of 10 participants seeking treatment for PTSD would have been excluded in a typical psychotherapy efficacy Trial. CONCLUSIONS We found that psychotherapy Trial Results may be applied to most patients with PTSD in routine Clinical practice. The designers of pharmacologic Clinical Trials should carefully consider the trade-offs between the application of each exclusion criterion and its impact on representativeness. Specification a priori of the goals of the study, better justification for each exclusion criterion, and estimation of the proportion of individuals ineligible for the Trial would assist study design. Developing integrated forms of pharmacotherapy and psychotherapy that simultaneously target commonly overlapping psychiatric disorders may yield more informative Results for mental health care providers and research funding agencies.
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Generalizability of Pharmacologic and Psychotherapy Clinical Trial Results for Posttraumatic Stress Disorder to Community Samples.
The Journal of Clinical Psychiatry, 2016Co-Authors: Silvia Franco, Nicolas Hoertel, Shuai Wang, Frédéric Limosin, Kibby Mcmahon, Jorge Mario Rodríguez-fernández, Hugo Peyre, Carlos BlancoAbstract:The present study sought to quantify the generalizability of pharmacologic and psychotherapy Clinical Trial Results in individuals with a DSM-IV diagnosis of posttraumatic stress disorder (PTSD) to a large representative community sample. Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large nationally representative sample of the adult US population. We applied a standard set of exclusion criteria representative of pharmacologic and psychotherapy Clinical Trials to all adults with a DSM-IV diagnosis of PTSD in the previous 12 months (n = 1,715) and then to a subsample of participants seeking treatment (n = 366). Our aim was to assess how many participants with PTSD would fulfill typical eligibility criteria. We found that more than 6 of 10 respondents from the overall PTSD sample and more than 7 of 10 respondents seeking treatment for PTSD would have been excluded by 1 exclusion criterion or more in a typical pharmacologic Trial. In contrast, about 2 of 10 participants in the full sample and about 3 of 10 participants seeking treatment for PTSD would have been excluded in a typical psychotherapy efficacy Trial. We found that psychotherapy Trial Results may be applied to most patients with PTSD in routine Clinical practice. The designers of pharmacologic Clinical Trials should carefully consider the trade-offs between the application of each exclusion criterion and its impact on representativeness. Specification a priori of the goals of the study, better justification for each exclusion criterion, and estimation of the proportion of individuals ineligible for the Trial would assist study design. Developing integrated forms of pharmacotherapy and psychotherapy that simultaneously target commonly overlapping psychiatric disorders may yield more informative Results for mental health care providers and research funding agencies. © Copyright 2016 Physicians Postgraduate Press, Inc.
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Generalizability of pharmacological and psychotherapy Clinical Trial Results for borderline personality disorder to community samples.
Personality Disorders: Theory Research and Treatment, 2015Co-Authors: Nicolas Hoertel, Saioa López, Shuai Wang, Ana González-pinto, Frédéric Limosin, Carlos BlancoAbstract:The present study sought to quantify the generalizability of Clinical Trial Results in individuals with a Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of borderline personality disorder (BPD) to a large representative community sample. Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large nationally representative sample of 34,653 adults from the United States population. We applied a standard set of exclusion criteria representative of pharmacological and psychotherapy Clinical Trials to all adults with a DSM-IV diagnosis of BPD (n = 2,231). Our aim was to assess how many participants with BPD would not fulfill typical eligibility criteria. We found that more than 7 of 10 respondents in a typical pharmacological efficacy Trial and more than 5 of 10 participants in a typical psychotherapy efficacy Trial would have been excluded by at least 1 criterion. Having a current history of alcohol or drug use disorder and a lifetime history of bipolar disorder explained a large proportion of ineligibility in both pharmacological and psychotherapy efficacy Trials. Clinical Trials should carefully consider the impact of exclusion criteria on the generalizability of their Results. As required by CONSORT guidelines, reporting exclusion rate estimate and reasons of eligibility should be mandatory in both Clinical Trials and meta-analyses. As treatment Trials of borderline personality disorder move from efficacy to effectiveness to better inform Clinical practice, the eligibility rate must be increased by imposing less stringent eligibility criteria to allow for more generalizable Results.
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Generalizability of Clinical Trial Results for generalized anxiety disorder to community samples.
Depression and Anxiety, 2012Co-Authors: Nicolas Hoertel, Carlos Blanco, Yann Le Strat, Pierre Lavaud, Caroline DubertretAbstract:Background There has been little research on the generalizability of Clinical Trials for generalized anxiety disorder (GAD). The present study examines the generalizability of pharmacological and psychotherapy Clinical Trials’ Results of individuals with DSM-IV GAD to a large community sample. Methods Data were drawn from the National Epidemiological Survey on Alcohol and Related Conditions (NESARC), a large national representative face-to-face sample of 43,093 adults of the United States population. We applied a standard set of eligibility criteria representative of GAD pharmacological and psychotherapy Clinical Trials to all adults with past 12 months GAD (n = 894), and to a subgroup of participants seeking treatment (n = 329). Our aim was to assess how many participants with GAD would fulfil typical eligibility criteria. Results We found that more than seven out of 10 participants with GAD were excluded by at least one criterion. In the subgroup of GAD participants who sought treatment, the exclusion rate by at least one criterion raised to more than eight out of 10 participants with GAD. For the overall sample and the treatment-seeking subsample, having a current depression was the criterion excluding the highest percentage of individuals. Having a lifetime history of bipolar disorder, a current significant medical condition, a current diagnosis of alcohol abuse or dependence, and a social or specific phobia also excluded a substantial proportion of individuals in both samples. Conclusions Clinical Trials exclude a majority of adults with GAD. Clinical Trials should carefully consider the impact of eligibility criteria on the generalizability of their Results. Depression and Anxiety 00:1–7, 2012. © 2012 Wiley Periodicals, Inc.
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Research Article GENERALIZABILITY OF Clinical Trial Results FOR GENERALIZED ANXIETY DISORDER TO COMMUNITY SAMPLES
2012Co-Authors: Nicolas Hoertel, Carlos Blanco, Yann Le Strat, Pierre Lavaud, Caroline DubertretAbstract:Background: There has been little research on the generalizability of Clinical Trials for generalized anxiety disorder (GAD). The present study examines the generalizability of pharmacological and psychotherapy Clinical Trials’ Results of individuals with DSM-IV GAD to a large community sample. Methods: Data were drawn from the National Epidemiological Survey on Alcohol and Related Conditions (NESARC), a large national representative face-to-face sample of 43,093 adults of the United States population. We applied a standard set of eligibility criteria representative of GAD pharmacological and psychotherapy Clinical Trials to all adults with past 12 months GAD (n = 894), and to a subgroup of participants seeking treatment (n = 329). Our aim was to assess how many participants with GAD would fulfil typical eligibility criteria. Results: We found that more than seven out of 10 participants with GAD were excluded by at least one criterion. In the subgroup of GAD participants who sought treatment, the exclusion rate by at least one criterion raised to more than eight out of 10 participants with GAD. For the overall sample and the treatment-seeking subsample, having a current depression was the criterion excluding the highest percentage of individuals. Having a lifetime history of bipolar disorder, a current significant medical condition, a current diagnosis of alcohol abuse or dependence, and a social or specific phobia also excluded a substantial proportion of individuals in both samples. Conclusions: Clinical Trials exclude a majority of adults with GAD. Clinical Trials should carefully consider the impact of eligibility criteria on the generalizability of their Results. Depression and Anxiety 29:614–620, 2012.
Larry W Kwak - One of the best experts on this subject based on the ideXlab platform.
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idiotype vaccine therapy biovaxid in follicular lymphoma in first complete remission phase iii Clinical Trial Results
Journal of Clinical Oncology, 2009Co-Authors: Stephen J Schuster, Sattva S Neelapu, Barry L Gause, Franco M Muggia, Jon P Gockerman, Eduardo M Sotomayor, Jane N Winter, Christopher R Flowers, A M Stergiou, Larry W KwakAbstract:2 Background: In previous Trials, tumor-specific purified idiotype (Id) protein conjugated to keyhole limpet hemocyanin (KLH) administered with granulocyte-monocyte colony-stimulating factor (GM-CSF) induced follicular lymphoma (FL)-specific immune responses and molecular remissions (Nat Med. 1999;5:1171–7). Methods: We conducted a prospective randomized double-blind placebo-controlled multicenter phase III study of patient-specific autologous tumor-derived Id vaccine in advanced stage previously untreated FL patients (pts) with a lymph node adequate for vaccine production (≥ 2cm). Pts achieving complete response (CR) or complete response unconfirmed (CRu) after chemotherapy (PACE: prednisone, doxorubicin, cyclophosphamide, etoposide) were stratified by International Prognostic Index risk group and randomized 2:1 to receive either vaccination with Id-KLH/GM-CSF or control (KLH/GM-CSF). The primary endpoint was disease free survival. Results: 234 pts were enrolled; 177 (76%) achieved CR/CRu and were random...
Nicolas Hoertel - One of the best experts on this subject based on the ideXlab platform.
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Generalizability of Pharmacologic and Psychotherapy Clinical Trial Results for Posttraumatic Stress Disorder to Community Samples.
The Journal of Clinical Psychiatry, 2016Co-Authors: Silvia Franco, Nicolas Hoertel, Shuai Wang, Frédéric Limosin, Kibby Mcmahon, Jorge Mario Rodríguez-fernández, Hugo Peyre, Carlos BlancoAbstract:The present study sought to quantify the generalizability of pharmacologic and psychotherapy Clinical Trial Results in individuals with a DSM-IV diagnosis of posttraumatic stress disorder (PTSD) to a large representative community sample. Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large nationally representative sample of the adult US population. We applied a standard set of exclusion criteria representative of pharmacologic and psychotherapy Clinical Trials to all adults with a DSM-IV diagnosis of PTSD in the previous 12 months (n = 1,715) and then to a subsample of participants seeking treatment (n = 366). Our aim was to assess how many participants with PTSD would fulfill typical eligibility criteria. We found that more than 6 of 10 respondents from the overall PTSD sample and more than 7 of 10 respondents seeking treatment for PTSD would have been excluded by 1 exclusion criterion or more in a typical pharmacologic Trial. In contrast, about 2 of 10 participants in the full sample and about 3 of 10 participants seeking treatment for PTSD would have been excluded in a typical psychotherapy efficacy Trial. We found that psychotherapy Trial Results may be applied to most patients with PTSD in routine Clinical practice. The designers of pharmacologic Clinical Trials should carefully consider the trade-offs between the application of each exclusion criterion and its impact on representativeness. Specification a priori of the goals of the study, better justification for each exclusion criterion, and estimation of the proportion of individuals ineligible for the Trial would assist study design. Developing integrated forms of pharmacotherapy and psychotherapy that simultaneously target commonly overlapping psychiatric disorders may yield more informative Results for mental health care providers and research funding agencies. © Copyright 2016 Physicians Postgraduate Press, Inc.
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Generalizability of Pharmacologic and Psychotherapy Clinical Trial Results for Posttraumatic Stress Disorder to Community Samples
The Journal of Clinical Psychiatry, 2016Co-Authors: Silvia Franco, Nicolas Hoertel, Shuai Wang, Frédéric Limosin, Kibby Mcmahon, Jorge Mario Rodríguez-fernández, Hugo Peyre, Carlos BlancoAbstract:OBJECTIVE The present study sought to quantify the generalizability of pharmacologic and psychotherapy Clinical Trial Results in individuals with a DSM-IV diagnosis of posttraumatic stress disorder (PTSD) to a large representative community sample. METHODS Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large nationally representative sample of the adult US population. We applied a standard set of exclusion criteria representative of pharmacologic and psychotherapy Clinical Trials to all adults with a DSM-IV diagnosis of PTSD in the previous 12 months (n = 1,715) and then to a subsample of participants seeking treatment (n = 366). Our aim was to assess how many participants with PTSD would fulfill typical eligibility criteria. Results We found that more than 6 of 10 respondents from the overall PTSD sample and more than 7 of 10 respondents seeking treatment for PTSD would have been excluded by 1 exclusion criterion or more in a typical pharmacologic Trial. In contrast, about 2 of 10 participants in the full sample and about 3 of 10 participants seeking treatment for PTSD would have been excluded in a typical psychotherapy efficacy Trial. CONCLUSIONS We found that psychotherapy Trial Results may be applied to most patients with PTSD in routine Clinical practice. The designers of pharmacologic Clinical Trials should carefully consider the trade-offs between the application of each exclusion criterion and its impact on representativeness. Specification a priori of the goals of the study, better justification for each exclusion criterion, and estimation of the proportion of individuals ineligible for the Trial would assist study design. Developing integrated forms of pharmacotherapy and psychotherapy that simultaneously target commonly overlapping psychiatric disorders may yield more informative Results for mental health care providers and research funding agencies.
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Generalizability of pharmacological and psychotherapy Clinical Trial Results for borderline personality disorder to community samples.
Personality Disorders: Theory Research and Treatment, 2015Co-Authors: Nicolas Hoertel, Saioa López, Shuai Wang, Ana González-pinto, Frédéric Limosin, Carlos BlancoAbstract:The present study sought to quantify the generalizability of Clinical Trial Results in individuals with a Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of borderline personality disorder (BPD) to a large representative community sample. Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large nationally representative sample of 34,653 adults from the United States population. We applied a standard set of exclusion criteria representative of pharmacological and psychotherapy Clinical Trials to all adults with a DSM-IV diagnosis of BPD (n = 2,231). Our aim was to assess how many participants with BPD would not fulfill typical eligibility criteria. We found that more than 7 of 10 respondents in a typical pharmacological efficacy Trial and more than 5 of 10 participants in a typical psychotherapy efficacy Trial would have been excluded by at least 1 criterion. Having a current history of alcohol or drug use disorder and a lifetime history of bipolar disorder explained a large proportion of ineligibility in both pharmacological and psychotherapy efficacy Trials. Clinical Trials should carefully consider the impact of exclusion criteria on the generalizability of their Results. As required by CONSORT guidelines, reporting exclusion rate estimate and reasons of eligibility should be mandatory in both Clinical Trials and meta-analyses. As treatment Trials of borderline personality disorder move from efficacy to effectiveness to better inform Clinical practice, the eligibility rate must be increased by imposing less stringent eligibility criteria to allow for more generalizable Results.
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Generalizability of Clinical Trial Results for bipolar disorder to community samples: findings from the national epidemiologic survey on alcohol and related conditions
The Journal of Clinical Psychiatry, 2013Co-Authors: Nicolas Hoertel, Yann Le Strat, Pierre Lavaud, Caroline Dubertret, Frédéric LimosinAbstract:BACKGROUND: Research on the generalizability of Clinical Trial Results for bipolar disorder is limited. The present post hoc study sought to quantify the generalizability of Clinical Trial Results in individuals with DSM-IV bipolar disorder to a large representative community sample. METHOD: Data were derived from the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large, nationally representative sample of 43,093 adults from the United States population. We applied a standard set of eligibility criteria representative of Clinical Trials to all adults with DSM-IV bipolar depression (n = 785) or mania (n = 724) in the past 12 months and then to a subsample of participants seeking treatment for bipolar depression (n = 276). Our aim was to determine the proportion of participants with bipolar depression or acute mania who would have been excluded from a Clinical Trial by typical eligibility criteria. Results: We found that more than 5 of 10 participants with bipolar depression (58.17%) or mania (55.75%) would have been excluded by at least 1 eligibility criterion. In the subgroup of participants with bipolar depression who sought treatment, the exclusion rate by at least 1 criterion was higher (63.87%). Having a significant risk of suicide was the criterion excluding the highest percentage of participants in the bipolar depression samples, while having a current DSM-IV diagnosis of alcohol abuse or dependence was the one leading to the greatest exclusion rate in Clinical Trials for participants with acute mania. Exclusion rates were higher for participants with bipolar I depression compared with those with bipolar II depression. CONCLUSIONS: Traditional Clinical Trials tend to exclude a majority of individuals with bipolar disorder. Clinical Trials should carefully consider the impact of eligibility criteria on the generalizability of their Results and explain the rationale for their use. Future Trials should weigh the trade-offs between internal validity and the representativeness of the study. Language: en
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Generalizability of Clinical Trial Results for generalized anxiety disorder to community samples.
Depression and Anxiety, 2012Co-Authors: Nicolas Hoertel, Carlos Blanco, Yann Le Strat, Pierre Lavaud, Caroline DubertretAbstract:Background There has been little research on the generalizability of Clinical Trials for generalized anxiety disorder (GAD). The present study examines the generalizability of pharmacological and psychotherapy Clinical Trials’ Results of individuals with DSM-IV GAD to a large community sample. Methods Data were drawn from the National Epidemiological Survey on Alcohol and Related Conditions (NESARC), a large national representative face-to-face sample of 43,093 adults of the United States population. We applied a standard set of eligibility criteria representative of GAD pharmacological and psychotherapy Clinical Trials to all adults with past 12 months GAD (n = 894), and to a subgroup of participants seeking treatment (n = 329). Our aim was to assess how many participants with GAD would fulfil typical eligibility criteria. Results We found that more than seven out of 10 participants with GAD were excluded by at least one criterion. In the subgroup of GAD participants who sought treatment, the exclusion rate by at least one criterion raised to more than eight out of 10 participants with GAD. For the overall sample and the treatment-seeking subsample, having a current depression was the criterion excluding the highest percentage of individuals. Having a lifetime history of bipolar disorder, a current significant medical condition, a current diagnosis of alcohol abuse or dependence, and a social or specific phobia also excluded a substantial proportion of individuals in both samples. Conclusions Clinical Trials exclude a majority of adults with GAD. Clinical Trials should carefully consider the impact of eligibility criteria on the generalizability of their Results. Depression and Anxiety 00:1–7, 2012. © 2012 Wiley Periodicals, Inc.
Antoine Tournoys - One of the best experts on this subject based on the ideXlab platform.
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Clinical Trial Results with antithrombin iii in sepsis
Critical Care Medicine, 2000Co-Authors: Francois Fourrier, Merce Jourdain, Antoine TournoysAbstract:Objective: To present and discuss the rationale and Results of Clinical Trials using antithrombin (AT) supplementation in patients with sepsis. Data Sources/Study Selection: Review of all controlled (open or double-blind) studies of patients with severe sepsis or septic shock who were treated with AT concentrates to obtain better control of coagulation activation and inflammation. Data Extraction: AT is a major inhibitor of the coagulation cascade. Recent experimental studies have also shown that it can modulate the inflammatory reactions that occur during sepsis. An early and prolonged decrease in AT activity is well documented during sepsis-induced disseminated intravascular coagulation and during the systemic inflammatory response. Thus, supplementation with AT concentrates has been proposed as a potential therapy in sepsis patients. Data Synthesis: Numerous uncontrolled studies of AT supplementation in sepsis patients have been reported in the last 20 yrs. Since 1993, four placebo-controlled randomized studies have been performed in France, Germany, Northwestern Europe, and Italy. Three of these studies were subjected to a meta-analysis of 122 patients. Results showed a nonsignificant 22% reduction in the 30-day all-cause mortality and a reduction in the length of stay in the intensive care unit in the AT treated group. The Italian study of 120 patients demonstrated that the overall mortality was similar in the placebo and treated groups. However, post hoc analysis according to the Cox regression model showed that in patients with septic shock, AT supplementation significantly decreased the risk of death. Conclusions: Together, these studies are consistent with the positive effect seen with AT supplementation in patients with severe sepsis. A multicenter phase III Trial is currently in progress to definitively document its effect on mortality.
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Clinical Trial Results with antithrombin III in sepsis.
Critical care medicine, 2000Co-Authors: Francois Fourrier, Merce Jourdain, Antoine TournoysAbstract:To present and discuss the rationale and Results of Clinical Trials using antithrombin (AT) supplementation in patients with sepsis. Review of all controlled (open or double-blind) studies of patients with severe sepsis or septic shock who were treated with AT concentrates to obtain better control of coagulation activation and inflammation. AT is a major inhibitor of the coagulation cascade. Recent experimental studies have also shown that it can modulate the inflammatory reactions that occur during sepsis. An early and prolonged decrease in AT activity is well documented during sepsis-induced disseminated intravascular coagulation and during the systemic inflammatory response. Thus, supplementation with AT concentrates has been proposed as a potential therapy in sepsis patients. Numerous uncontrolled studies of AT supplementation in sepsis patients have been reported in the last 20 yrs. Since 1993, four placebo-controlled randomized studies have been performed in France, Germany, Northwestern Europe, and Italy. Three of these studies were subjected to a meta-analysis of 122 patients. Results showed a nonsignificant 22% reduction in the 30-day all-cause mortality and a reduction in the length of stay in the intensive care unit in the AT treated group. The Italian study of 120 patients demonstrated that the overall mortality was similar in the placebo and treated groups. However, post hoc analysis according to the Cox regression model showed that in patients with septic shock, AT supplementation significantly decreased the risk of death. Together, these studies are consistent with the positive effect seen with AT supplementation in patients with severe sepsis. A multicenter phase III Trial is currently in progress to definitively document its effect on mortality.
Raphael E Pollock - One of the best experts on this subject based on the ideXlab platform.
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novel systemic therapies in advanced liposarcoma a review of recent Clinical Trial Results
Cancers, 2013Co-Authors: William W Tseng, Neeta Somaiah, Alexander J Lazar, Raphael E PollockAbstract:Liposarcoma is one of the most common adult soft tissue sarcomas and consists of three histologic subtypes (well and dedifferentiated, myxoid/round cell, and pleomorphic). Surgery is the mainstay of treatment for localized disease; however for unresectable or metastatic disease, effective treatment options are currently limited. In the past decade, a better understanding of the distinct genetic and molecular aberrations for each of the three histologic subtypes has led to the development of several novel systemic therapies. Data from phase I and early phase II Clinical Trials have been reported. Despite challenges with conducting Clinical Trials in liposarcoma, preliminary Results for several of these novel, biology-driven therapies are encouraging.