The Experts below are selected from a list of 147 Experts worldwide ranked by ideXlab platform

Pesanai Chatikobo - One of the best experts on this subject based on the ideXlab platform.

  • A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex™ Device to Forceps Guided Surgical Circumcision in Zimbabwe.
    PloS one, 2016
    Co-Authors: Mufuta Tshimanga, Tonderayi Mangwiro, Owen Mugurungi, Sinokuthemba Xaba, Munyaradzi Murwira, Danuta Kasprzyk, Daniel E. Montaño, Daisy Nyamukapa, Basile O. Tambashe, Pesanai Chatikobo
    Abstract:

    Background The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, Procedure time, and cost) of the PrePex Device compared to forceps-guided surgical circumcision. Methods and Findings This Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex Device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the Procedures. The PrePex Device Procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total Procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-Procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total Procedure time for the PrePex Device was approximately one-third of the total surgical Procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p

  • a phase ii randomized controlled trial comparing safety Procedure time and cost of the prepex Device to forceps guided surgical circumcision in zimbabwe
    PLOS ONE, 2016
    Co-Authors: Mufuta Tshimanga, Tonderayi Mangwiro, Owen Mugurungi, Sinokuthemba Xaba, Munyaradzi Murwira, Danuta Kasprzyk, Daniel E. Montaño, Daisy Nyamukapa, Basile O. Tambashe, Pesanai Chatikobo
    Abstract:

    Background The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, Procedure time, and cost) of the PrePex Device compared to forceps-guided surgical circumcision. Methods and Findings This Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex Device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the Procedures. The PrePex Device Procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total Procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-Procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total Procedure time for the PrePex Device was approximately one-third of the total surgical Procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p<0.00001). There were 2 AEs for 2 participants (rate of 1.3%, 95% Confidence Interval: 0.0025–4.53%), which were resolved with simple intervention. The AEs were Device related, including 1 case of pain leading to Device removal and 1 case of removal of the Device. Conclusions The trial supports previous studies’ conclusions that the PrePex Procedure is safe, quick, easy to apply, and effective in terms of Procedure time as an alternative to traditional surgical circumcision. The PrePex Device has great potential for use in overburdened health systems and in resource-limited settings and is recommended for use in rapid scale-up of adult MC in Zimbabwe. Trial Registration ClinicalTrials.gov NCT01956370

Hilary Short - One of the best experts on this subject based on the ideXlab platform.

  • Involving Patients in Reducing Decision Uncertainties Around Orphan and Ultra-Orphan Drugs: A Rare Opportunity?
    The Patient - Patient-Centered Outcomes Research, 2015
    Co-Authors: Devidas Menon, Tania Stafinski, Andrea Dunn, Hilary Short
    Abstract:

    Introduction Uncertainty influences the amount of risk in decision making, and is typically related to clinical benefit, value for money, affordability, and/or adoption/diffusion of the technology (e.g., drug, Device, Procedure, etc.). Although evidence-based review processes within each stage of the technology lifecycle have been implemented to minimize uncertainty, high-quality information addressing that related to orphan and ultra-orphan drugs is often unavailable. The role that patients, as experts in their disease, may play in providing such information has yet to be fully explored. Objective The objective of this systematic review was to identify existing and proposed opportunities for patients with rare diseases and their families to provide input aimed at reducing decision uncertainties throughout the lifecycle of an orphan or ultra-orphan drug. Methods A comprehensive review of published and gray literature describing roles for patients and families in activities related to orphan and ultra-orphan drugs was conducted. In addition, the websites of regulatory and centralized reimbursement decision-making bodies in the top 22 OECD (Organisation for Economic Cooperation and Development) countries by gross domestic product (GDP) were scanned to identify current opportunities for patients with rare diseases in both stages. The websites of umbrella patient organizations for rare diseases in these countries were also scanned. These roles were then mapped onto a matrix to determine the stage in the technology lifecycle and types of uncertainties they directly or indirectly addressed. Results Across the 22 countries, nine roles for patients within regulatory related processes were identified, with at least one in each country. These roles were not specific to patients with rare diseases. Similarly, six different opportunities for patient input in centralized drug review processes were identified, all of which applied to patients, in general, rather than just those with rare diseases. ‘Real-world’ examples of patient involvement explicitly related to rare diseases centered around 11 different themes. Seven fell within the research and development or clinical trial stages of a drug’s lifecycle. Of the remaining four, three were associated with education and advocacy. All of the proposed roles identified focused on greater involvement in (1) the design and conduct of clinical trials, or (2) the ‘valuation’ of evidence during reimbursement decision making. When mapped onto the matrix of decision uncertainties, almost all of the existing and proposed roles addressed ‘clinical benefit’. Roles for patients in reducing ‘value for money’, affordability, or adoption/diffusion uncertainties were mainly indirect, and a result of patient involvement in activities aimed at generating information on clinical benefit, which is then used to inform discussions around these uncertainties. Conclusions While patient involvement in activities that directly address uncertainties in clinical benefit may not be ‘rare’, opportunities for reducing those related to ‘value for money’, affordability, and adoption/diffusion remain scarce.

  • Involving patients in reducing decision uncertainties around orphan and ultra-orphan drugs: a rare opportunity?
    The patient, 2014
    Co-Authors: Devidas Menon, Tania Stafinski, Andrea Dunn, Hilary Short
    Abstract:

    Introduction Uncertainty influences the amount of risk in decision making, and is typically related to clinical benefit, value for money, affordability, and/or adoption/diffusion of the technology (e.g., drug, Device, Procedure, etc.). Although evidence-based review processes within each stage of the technology lifecycle have been implemented to minimize uncertainty, high-quality information addressing that related to orphan and ultra-orphan drugs is often unavailable. The role that patients, as experts in their disease, may play in providing such information has yet to be fully explored.

Mufuta Tshimanga - One of the best experts on this subject based on the ideXlab platform.

  • A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex™ Device to Forceps Guided Surgical Circumcision in Zimbabwe.
    PloS one, 2016
    Co-Authors: Mufuta Tshimanga, Tonderayi Mangwiro, Owen Mugurungi, Sinokuthemba Xaba, Munyaradzi Murwira, Danuta Kasprzyk, Daniel E. Montaño, Daisy Nyamukapa, Basile O. Tambashe, Pesanai Chatikobo
    Abstract:

    Background The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, Procedure time, and cost) of the PrePex Device compared to forceps-guided surgical circumcision. Methods and Findings This Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex Device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the Procedures. The PrePex Device Procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total Procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-Procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total Procedure time for the PrePex Device was approximately one-third of the total surgical Procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p

  • a phase ii randomized controlled trial comparing safety Procedure time and cost of the prepex Device to forceps guided surgical circumcision in zimbabwe
    PLOS ONE, 2016
    Co-Authors: Mufuta Tshimanga, Tonderayi Mangwiro, Owen Mugurungi, Sinokuthemba Xaba, Munyaradzi Murwira, Danuta Kasprzyk, Daniel E. Montaño, Daisy Nyamukapa, Basile O. Tambashe, Pesanai Chatikobo
    Abstract:

    Background The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, Procedure time, and cost) of the PrePex Device compared to forceps-guided surgical circumcision. Methods and Findings This Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex Device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the Procedures. The PrePex Device Procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total Procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-Procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total Procedure time for the PrePex Device was approximately one-third of the total surgical Procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p<0.00001). There were 2 AEs for 2 participants (rate of 1.3%, 95% Confidence Interval: 0.0025–4.53%), which were resolved with simple intervention. The AEs were Device related, including 1 case of pain leading to Device removal and 1 case of removal of the Device. Conclusions The trial supports previous studies’ conclusions that the PrePex Procedure is safe, quick, easy to apply, and effective in terms of Procedure time as an alternative to traditional surgical circumcision. The PrePex Device has great potential for use in overburdened health systems and in resource-limited settings and is recommended for use in rapid scale-up of adult MC in Zimbabwe. Trial Registration ClinicalTrials.gov NCT01956370

Devidas Menon - One of the best experts on this subject based on the ideXlab platform.

  • Involving Patients in Reducing Decision Uncertainties Around Orphan and Ultra-Orphan Drugs: A Rare Opportunity?
    The Patient - Patient-Centered Outcomes Research, 2015
    Co-Authors: Devidas Menon, Tania Stafinski, Andrea Dunn, Hilary Short
    Abstract:

    Introduction Uncertainty influences the amount of risk in decision making, and is typically related to clinical benefit, value for money, affordability, and/or adoption/diffusion of the technology (e.g., drug, Device, Procedure, etc.). Although evidence-based review processes within each stage of the technology lifecycle have been implemented to minimize uncertainty, high-quality information addressing that related to orphan and ultra-orphan drugs is often unavailable. The role that patients, as experts in their disease, may play in providing such information has yet to be fully explored. Objective The objective of this systematic review was to identify existing and proposed opportunities for patients with rare diseases and their families to provide input aimed at reducing decision uncertainties throughout the lifecycle of an orphan or ultra-orphan drug. Methods A comprehensive review of published and gray literature describing roles for patients and families in activities related to orphan and ultra-orphan drugs was conducted. In addition, the websites of regulatory and centralized reimbursement decision-making bodies in the top 22 OECD (Organisation for Economic Cooperation and Development) countries by gross domestic product (GDP) were scanned to identify current opportunities for patients with rare diseases in both stages. The websites of umbrella patient organizations for rare diseases in these countries were also scanned. These roles were then mapped onto a matrix to determine the stage in the technology lifecycle and types of uncertainties they directly or indirectly addressed. Results Across the 22 countries, nine roles for patients within regulatory related processes were identified, with at least one in each country. These roles were not specific to patients with rare diseases. Similarly, six different opportunities for patient input in centralized drug review processes were identified, all of which applied to patients, in general, rather than just those with rare diseases. ‘Real-world’ examples of patient involvement explicitly related to rare diseases centered around 11 different themes. Seven fell within the research and development or clinical trial stages of a drug’s lifecycle. Of the remaining four, three were associated with education and advocacy. All of the proposed roles identified focused on greater involvement in (1) the design and conduct of clinical trials, or (2) the ‘valuation’ of evidence during reimbursement decision making. When mapped onto the matrix of decision uncertainties, almost all of the existing and proposed roles addressed ‘clinical benefit’. Roles for patients in reducing ‘value for money’, affordability, or adoption/diffusion uncertainties were mainly indirect, and a result of patient involvement in activities aimed at generating information on clinical benefit, which is then used to inform discussions around these uncertainties. Conclusions While patient involvement in activities that directly address uncertainties in clinical benefit may not be ‘rare’, opportunities for reducing those related to ‘value for money’, affordability, and adoption/diffusion remain scarce.

  • Involving patients in reducing decision uncertainties around orphan and ultra-orphan drugs: a rare opportunity?
    The patient, 2014
    Co-Authors: Devidas Menon, Tania Stafinski, Andrea Dunn, Hilary Short
    Abstract:

    Introduction Uncertainty influences the amount of risk in decision making, and is typically related to clinical benefit, value for money, affordability, and/or adoption/diffusion of the technology (e.g., drug, Device, Procedure, etc.). Although evidence-based review processes within each stage of the technology lifecycle have been implemented to minimize uncertainty, high-quality information addressing that related to orphan and ultra-orphan drugs is often unavailable. The role that patients, as experts in their disease, may play in providing such information has yet to be fully explored.

Basile O. Tambashe - One of the best experts on this subject based on the ideXlab platform.

  • A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex™ Device to Forceps Guided Surgical Circumcision in Zimbabwe.
    PloS one, 2016
    Co-Authors: Mufuta Tshimanga, Tonderayi Mangwiro, Owen Mugurungi, Sinokuthemba Xaba, Munyaradzi Murwira, Danuta Kasprzyk, Daniel E. Montaño, Daisy Nyamukapa, Basile O. Tambashe, Pesanai Chatikobo
    Abstract:

    Background The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, Procedure time, and cost) of the PrePex Device compared to forceps-guided surgical circumcision. Methods and Findings This Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex Device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the Procedures. The PrePex Device Procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total Procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-Procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total Procedure time for the PrePex Device was approximately one-third of the total surgical Procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p

  • a phase ii randomized controlled trial comparing safety Procedure time and cost of the prepex Device to forceps guided surgical circumcision in zimbabwe
    PLOS ONE, 2016
    Co-Authors: Mufuta Tshimanga, Tonderayi Mangwiro, Owen Mugurungi, Sinokuthemba Xaba, Munyaradzi Murwira, Danuta Kasprzyk, Daniel E. Montaño, Daisy Nyamukapa, Basile O. Tambashe, Pesanai Chatikobo
    Abstract:

    Background The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, Procedure time, and cost) of the PrePex Device compared to forceps-guided surgical circumcision. Methods and Findings This Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex Device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the Procedures. The PrePex Device Procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total Procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-Procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total Procedure time for the PrePex Device was approximately one-third of the total surgical Procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p<0.00001). There were 2 AEs for 2 participants (rate of 1.3%, 95% Confidence Interval: 0.0025–4.53%), which were resolved with simple intervention. The AEs were Device related, including 1 case of pain leading to Device removal and 1 case of removal of the Device. Conclusions The trial supports previous studies’ conclusions that the PrePex Procedure is safe, quick, easy to apply, and effective in terms of Procedure time as an alternative to traditional surgical circumcision. The PrePex Device has great potential for use in overburdened health systems and in resource-limited settings and is recommended for use in rapid scale-up of adult MC in Zimbabwe. Trial Registration ClinicalTrials.gov NCT01956370