Risk Benefit Analysis

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Patrick Mitchell - One of the best experts on this subject based on the ideXlab platform.

  • RiskBenefit Analysis of the treatment of unruptured intracranial aneurysms
    Journal of neurology neurosurgery and psychiatry, 2005
    Co-Authors: R R Vindlacheruvu, A D Mendelow, Patrick Mitchell
    Abstract:

    Objectives: To determine under what circumstances repair of unruptured intracranial aneurysms may be beneficial. Methods: A life expectancy Analysis of patients with unruptured aneurysms with and without repair based on prospective data from the International Study of Unruptured Intracranial Aneurysms (ISUIA). Results: Life years are lost at all ages by repairing anterior circulation aneurysms under 7 mm in diameter in patients with no history of a subarachnoid haemorrhage from another aneurysm (incidental). For all other aneurysms the number of life years saved by repair is dependent on the patient’s age at the time when repair is undertaken. Between 2 and 40 years are saved by repairing aneurysms in patients aged 20 years. These Benefits fall to 0 when remaining life expectancy falls below 15–35 years, corresponding to the age range of 45–70 years. Conclusions: Repair of unruptured aneurysms Benefits patients harbouring them by improving life expectancy except in certain circumstances. The exceptions are patients with remaining life expectancy less than 15–35 years or aged 45–70 (depending on aneurysm size and location) and patients with aneurysms of the anterior circulation under 7 mm in diameter with no history of a previous subarachnoid haemorrhage. These results are based on the findings of the ISUIA and are dependent on their accuracy.

  • Risk Benefit Analysis of the treatment of unruptured intracranial aneurysms
    Journal of Neurology Neurosurgery and Psychiatry, 2005
    Co-Authors: R R Vindlacheruvu, A D Mendelow, Patrick Mitchell
    Abstract:

    Objectives: To determine under what circumstances repair of unruptured intracranial aneurysms may be beneficial. Methods: A life expectancy Analysis of patients with unruptured aneurysms with and without repair based on prospective data from the International Study of Unruptured Intracranial Aneurysms (ISUIA). Results: Life years are lost at all ages by repairing anterior circulation aneurysms under 7 mm in diameter in patients with no history of a subarachnoid haemorrhage from another aneurysm (incidental). For all other aneurysms the number of life years saved by repair is dependent on the patient’s age at the time when repair is undertaken. Between 2 and 40 years are saved by repairing aneurysms in patients aged 20 years. These Benefits fall to 0 when remaining life expectancy falls below 15–35 years, corresponding to the age range of 45–70 years. Conclusions: Repair of unruptured aneurysms Benefits patients harbouring them by improving life expectancy except in certain circumstances. The exceptions are patients with remaining life expectancy less than 15–35 years or aged 45–70 (depending on aneurysm size and location) and patients with aneurysms of the anterior circulation under 7 mm in diameter with no history of a previous subarachnoid haemorrhage. These results are based on the findings of the ISUIA and are dependent on their accuracy.

R R Vindlacheruvu - One of the best experts on this subject based on the ideXlab platform.

  • RiskBenefit Analysis of the treatment of unruptured intracranial aneurysms
    Journal of neurology neurosurgery and psychiatry, 2005
    Co-Authors: R R Vindlacheruvu, A D Mendelow, Patrick Mitchell
    Abstract:

    Objectives: To determine under what circumstances repair of unruptured intracranial aneurysms may be beneficial. Methods: A life expectancy Analysis of patients with unruptured aneurysms with and without repair based on prospective data from the International Study of Unruptured Intracranial Aneurysms (ISUIA). Results: Life years are lost at all ages by repairing anterior circulation aneurysms under 7 mm in diameter in patients with no history of a subarachnoid haemorrhage from another aneurysm (incidental). For all other aneurysms the number of life years saved by repair is dependent on the patient’s age at the time when repair is undertaken. Between 2 and 40 years are saved by repairing aneurysms in patients aged 20 years. These Benefits fall to 0 when remaining life expectancy falls below 15–35 years, corresponding to the age range of 45–70 years. Conclusions: Repair of unruptured aneurysms Benefits patients harbouring them by improving life expectancy except in certain circumstances. The exceptions are patients with remaining life expectancy less than 15–35 years or aged 45–70 (depending on aneurysm size and location) and patients with aneurysms of the anterior circulation under 7 mm in diameter with no history of a previous subarachnoid haemorrhage. These results are based on the findings of the ISUIA and are dependent on their accuracy.

  • Risk Benefit Analysis of the treatment of unruptured intracranial aneurysms
    Journal of Neurology Neurosurgery and Psychiatry, 2005
    Co-Authors: R R Vindlacheruvu, A D Mendelow, Patrick Mitchell
    Abstract:

    Objectives: To determine under what circumstances repair of unruptured intracranial aneurysms may be beneficial. Methods: A life expectancy Analysis of patients with unruptured aneurysms with and without repair based on prospective data from the International Study of Unruptured Intracranial Aneurysms (ISUIA). Results: Life years are lost at all ages by repairing anterior circulation aneurysms under 7 mm in diameter in patients with no history of a subarachnoid haemorrhage from another aneurysm (incidental). For all other aneurysms the number of life years saved by repair is dependent on the patient’s age at the time when repair is undertaken. Between 2 and 40 years are saved by repairing aneurysms in patients aged 20 years. These Benefits fall to 0 when remaining life expectancy falls below 15–35 years, corresponding to the age range of 45–70 years. Conclusions: Repair of unruptured aneurysms Benefits patients harbouring them by improving life expectancy except in certain circumstances. The exceptions are patients with remaining life expectancy less than 15–35 years or aged 45–70 (depending on aneurysm size and location) and patients with aneurysms of the anterior circulation under 7 mm in diameter with no history of a previous subarachnoid haemorrhage. These results are based on the findings of the ISUIA and are dependent on their accuracy.

Marc Makeieff - One of the best experts on this subject based on the ideXlab platform.

  • Prophylactic neck dissection for low-Risk differentiated thyroid cancers: Risk-Benefit Analysis
    Archives of Otorhinolaryngology - Head & Neck Surgery, 2016
    Co-Authors: Xavier Dubernard, Sandrine Dabakuyo, Samiratou Ouédraogo, Koceila Amroun, David Kere, Talal Nasser, Sophie Deguelte, Jean-marie Pochart, Jean-claude Mérol, Marc Makeieff
    Abstract:

    Background. The Benefit of neck dissection is the subject of debate in differentiated thyroid cancer (DTC). We analyze the Risk-Benefit of neck dissection for low-Risk DTC without detectable lymph nodes. Methods. We conducted a retrospective study from 1983 to 2003; which included 295 patients without detectable lymph nodes who were treated by thyroidectomy with (C1) or without (C-) neck dissection. All patients had iodine131 therapy. We compared the frequency of remission, disease progression, and permanent complications between groups. Results. Two hundred twelve patients comprised the C1 group, and 83 patients the C-group. Respectively for C1 versus C-, remission rates were 92% versus 89.2% (p 5 .40), and progressive disease observed was 3.3% versus 7.2% (p 5 .10). Permanent hypoparathyroidism occurred in 15.1% in C1 versus 3.6% in C-(p 5 .006). Conclusion. The Risk-Benefit Analysis of neck dissection in patients with low-Risk DTC shows no Benefit in terms of complete remission or occurrence of progression. However, Risk of complications seems to be higher in patients with neck dissection.

  • Prophylactic neck dissection for low-Risk differentiated thyroid cancers: Risk-Benefit Analysis
    Head & neck, 2016
    Co-Authors: Xavier Dubernard, Sandrine Dabakuyo, Samiratou Ouédraogo, Koceila Amroun, David Kere, Talal Nasser, Sophie Deguelte, Jean-marie Pochart, Jean-claude Mérol, Marc Makeieff
    Abstract:

    Background The Benefit of neck dissection is the subject of debate in differentiated thyroid cancer (DTC). We analyze the Risk-Benefit of neck dissection for low-Risk DTC without detectable lymph nodes. Methods We conducted a retrospective study from 1983 to 2003; which included 295 patients without detectable lymph nodes who were treated by thyroidectomy with (C+) or without (C-) neck dissection. All patients had iodine131 therapy. We compared the frequency of remission, disease progression, and permanent complications between groups. Results Two hundred twelve patients comprised the C+ group, and 83 patients the C- group. Respectively for C+ versus C-, remission rates were 92% versus 89.2% (p = .40), and progressive disease observed was 3.3% versus 7.2% (p = .10). Permanent hypoparathyroidism occurred in 15.1% in C+ versus 3.6% in C- (p = .006). Conclusion The Risk-Benefit Analysis of neck dissection in patients with low-Risk DTC shows no Benefit in terms of complete remission or occurrence of progression. However, Risk of complications seems to be higher in patients with neck dissection. © 2016 Wiley Periodicals, Inc. Head Neck, 2016

Adonis Stassinopoulos - One of the best experts on this subject based on the ideXlab platform.

  • a patient oriented Risk Benefit Analysis of pathogen inactivated blood components application to apheresis platelets in the united states
    Transfusion, 2013
    Co-Authors: Steven Kleinman, William J. Reed, Adonis Stassinopoulos
    Abstract:

    We performed a RiskBenefit Analysis for implementation of pathogen-inactivated (PI) apheresis platelets (APs) in the United States, focusing on the amotosalen/ ultraviolet-A system. Risks and Benefits were quantified per patient assuming a mean of 6 AP units per treatment cycle and using available clinical data, mathematical modeling, and observational studies. Current Risks associated with AP transfusion can be divided into known partially addressed Risks, known well-addressed Risks, and unknown Risks associated with acute or chronic emerging infectious agents (EIAs). Bacterial contamination dominates the first category, at a per-patient rate of 1:250, which correlates with an estimated septic transfusion reaction rate of 1:1000. Quantitation of per-patient EIA Risk was modeled to be between 1:370 (acute) and 1:667 (chronic). Due to its broad range of action PI is expected to reduce or eliminate these infectious Risks and also to reduce the rate of febrile transfusion reactions and possibly alloimmunization. These Benefits are weighed against 1) concerns for excess bleeding, 2) an apparent increase in acute respiratory distress syndrome in the initial report of the SPRINT clinical trial, and 3) the possible toxicity associated with the introduction of a new chemical into platelet (PLT) units. However, transfusion of an estimated 100,000 patients with PI PLTs worldwide has occurred without reported serious adverse effects. We conclude that evidence indicates a favorable RiskBenefit profile for the implementation of PLT PI and argues for a path forward toward US regulatory approval. A n important factor in deciding to implement a new blood safety technology is a positive RiskBenefit assessment. For pathogen inactivation (PI), this equates to comparing the Risks averted by introducing the technology (i.e., the Benefit derived) to the Risks incurred, which are those of excess treatmentrelated adverse effects. These incurred Risks, determined through clinical trials, use the patient as the unit of measurement, for example, the occurrence of clinically significant bleeding in a percentage of treated patients. Because incurred Risks are quantified on a “per-patient” basis, it is necessary to use the same unit of measurement (e.g., the patient) to quantitate Risks that are averted. However, infectious Risks of transfusion are generally reported on a

  • A patient-oriented RiskBenefit Analysis of pathogen-inactivated blood components: application to apheresis platelets in the United States
    Transfusion, 2012
    Co-Authors: Steven Kleinman, William J. Reed, Adonis Stassinopoulos
    Abstract:

    We performed a RiskBenefit Analysis for implementation of pathogen-inactivated (PI) apheresis platelets (APs) in the United States, focusing on the amotosalen/ ultraviolet-A system. Risks and Benefits were quantified per patient assuming a mean of 6 AP units per treatment cycle and using available clinical data, mathematical modeling, and observational studies. Current Risks associated with AP transfusion can be divided into known partially addressed Risks, known well-addressed Risks, and unknown Risks associated with acute or chronic emerging infectious agents (EIAs). Bacterial contamination dominates the first category, at a per-patient rate of 1:250, which correlates with an estimated septic transfusion reaction rate of 1:1000. Quantitation of per-patient EIA Risk was modeled to be between 1:370 (acute) and 1:667 (chronic). Due to its broad range of action PI is expected to reduce or eliminate these infectious Risks and also to reduce the rate of febrile transfusion reactions and possibly alloimmunization. These Benefits are weighed against 1) concerns for excess bleeding, 2) an apparent increase in acute respiratory distress syndrome in the initial report of the SPRINT clinical trial, and 3) the possible toxicity associated with the introduction of a new chemical into platelet (PLT) units. However, transfusion of an estimated 100,000 patients with PI PLTs worldwide has occurred without reported serious adverse effects. We conclude that evidence indicates a favorable RiskBenefit profile for the implementation of PLT PI and argues for a path forward toward US regulatory approval. A n important factor in deciding to implement a new blood safety technology is a positive RiskBenefit assessment. For pathogen inactivation (PI), this equates to comparing the Risks averted by introducing the technology (i.e., the Benefit derived) to the Risks incurred, which are those of excess treatmentrelated adverse effects. These incurred Risks, determined through clinical trials, use the patient as the unit of measurement, for example, the occurrence of clinically significant bleeding in a percentage of treated patients. Because incurred Risks are quantified on a “per-patient” basis, it is necessary to use the same unit of measurement (e.g., the patient) to quantitate Risks that are averted. However, infectious Risks of transfusion are generally reported on a

Michaël Schwarzinger - One of the best experts on this subject based on the ideXlab platform.

  • Impact on Life Expectancy of Withdrawing Thiopurines in Patients with Crohn’s Disease in Sustained Clinical Remission: A Lifetime Risk-Benefit Analysis
    PloS one, 2016
    Co-Authors: Julien Kirchgesner, Laurent Beaugerie, Fabrice Carrat, Harry Sokol, Jacques Cosnes, Michaël Schwarzinger
    Abstract:

    Objective Long-term treatment with thiopurines is associated with a decreased Risk of Crohn’s disease (CD) flare but an increased Risk of various cancers depending on gender, age, and presence of extensive colitis. We evaluated Risks and Benefits of withdrawing thiopurines in patients with CD in prolonged remission. Methods We developed a Markov model assessing Risks and Benefits of withdrawing thiopurines compared to continuing thiopurines in a lifetime horizon. The model was stratified by age (35 and 65 years old at thiopurine withdrawal), gender and presence of extensive colitis. Parameter estimates were taken from French cohorts and hospital databases, cancer and death national registries and published literature. Life expectancy, rates of relapse, serious adverse events, and causes-of-death were evaluated. Results In patients without extensive colitis, continuing thiopurines increased life expectancy up to 0.03 years for 35 year-old men and women but decreased life expectancy down to 0.07 years for 65 year-old men and women. Withdrawal strategy became the preferred strategy at 40.6 years for men, and 45.7 years for women without extensive colitis. In patients with extensive colitis, continuation strategy was the preferred strategy regardless of age. Risk-Benefit Analysis was not modified by duration of CD activity. Conclusions Factors determining life expectancy associated with withdrawal or continuation of thiopurines in patients with CD and in sustained clinical remission vary substantially according to gender, age and presence of extensive colitis. Individual decisions to continue or withdraw thiopurines in patients with CD in sustained remission should take into account these parameters.

  • impact on life expectancy of withdrawing thiopurines in patients with crohn s disease in sustained clinical remission a lifetime Risk Benefit Analysis
    PLOS ONE, 2016
    Co-Authors: Julien Kirchgesner, Laurent Beaugerie, Fabrice Carrat, Harry Sokol, Jacques Cosnes, Michaël Schwarzinger
    Abstract:

    Objective Long-term treatment with thiopurines is associated with a decreased Risk of Crohn’s disease (CD) flare but an increased Risk of various cancers depending on gender, age, and presence of extensive colitis. We evaluated Risks and Benefits of withdrawing thiopurines in patients with CD in prolonged remission. Methods We developed a Markov model assessing Risks and Benefits of withdrawing thiopurines compared to continuing thiopurines in a lifetime horizon. The model was stratified by age (35 and 65 years old at thiopurine withdrawal), gender and presence of extensive colitis. Parameter estimates were taken from French cohorts and hospital databases, cancer and death national registries and published literature. Life expectancy, rates of relapse, serious adverse events, and causes-of-death were evaluated. Results In patients without extensive colitis, continuing thiopurines increased life expectancy up to 0.03 years for 35 year-old men and women but decreased life expectancy down to 0.07 years for 65 year-old men and women. Withdrawal strategy became the preferred strategy at 40.6 years for men, and 45.7 years for women without extensive colitis. In patients with extensive colitis, continuation strategy was the preferred strategy regardless of age. Risk-Benefit Analysis was not modified by duration of CD activity. Conclusions Factors determining life expectancy associated with withdrawal or continuation of thiopurines in patients with CD and in sustained clinical remission vary substantially according to gender, age and presence of extensive colitis. Individual decisions to continue or withdraw thiopurines in patients with CD in sustained remission should take into account these parameters.