- Email: [email protected]
Use of Cochrane evidence in supporting medical policies of oncology drugs in the United States
S120
Abstracts
obtained from the original questionnaire used to describe nurses’ selfefficacy of their sensitive outcomes in five domains (i.e. health promotions; daily activities interferences; ancillary outcomes; avoid dangers; learning outcomes) where only items related to cancer patients cardiotoxicity effects were used (n = 15). The items rated on a five-point response scale (1 = completely no confidence; 5 = completely confidence). Results: Nurses showed an overall low self-efficacy related to their sensitive outcomes in managing cancer patients cardiotoxicity effects (mean = 3.1±0.47). There was a slight positive correlation between age and self-efficacy (r = +0.271; p-value = 0.021), therefore experienced nurses reported higher self-efficacy level. Furthermore, the cancer nurses with a post-graduate education (n = 38) had higher self-efficacy scoring (r = +0.314; p-value = 0.003). Scores were not significantly different among hospitals (p-value >0.05). The items with the higher scoring were related to the patients’ education while the items with the lower scoring were related to the monitoring and understanding of cardiotoxicity effects. Besides, the analyzed items showed a good internal consistency (Cronbach’s a = 0.88). Conclusions: Although this study has several limitations mainly related to the data collection (self-report measurement), the findings could be very useful to plane a tailored education for cancer nurses, considering how the nurses self-efficacy responses show a general low confidence to face with cardiotoxicity effects. Moreover, some important relations need to be further explored, especially regarding the age, the gender, and the education differences. Indeed, tailored educational path for cancer nurses have to be developed. No conflict of interest. 1084 POSTER Use of Cochrane evidence in supporting medical policies of oncology drugs in the United States S. Hussain1 , A.K. Najmi2 , A. Singh3 . 1 Jamia Hamdard- Hamdard University, Department of Pharmacology- Pharmaceutical Medicine, New Delhi, India; 2 Jamia Hamdard- Hamdard University, Department of Pharmacology, New Delhi, India; 3 Anna University, Department of Biotechnology, Chennai, India Background: Cancer is the second leading cause of mortality in the US. Treatment of cancer imposes an enormous economic burden on US private payers. Private payer medical policies are developed using published clinical evidence. The systematic reviews (SR) are considered as the highest quality evidence and are used to inform the clinical guideline and medical policies. Cochrane collaboration develops SR to inform healthcare decisions making. This study assesses the influence of Cochrane SR on the private payers medical policies of the drugs used for the treatment of cancer. Method: The publically available medical policy documents of the drugs used for the treatment of cancer were scanned for the top four private insurers from the US, which together cover half of the US market, namely: UnitedHealthcare (UHG), Anthem, Aetna, and Cigna. The Cochrane SR used to inform these policy documents were identified by hand-searching. The relevant information such as the use of Cochrane SR, number of SR used, context of use of SR, Impact of SR on policy, Cochrane review group and center to which SR belongs, and other data were extracted from each of the policy document. Results: A total of 39 SR were used to inform 54 policy documents of the oncology therapies. Less than a quarter (22%) of policy documents of oncology drugs of US private payers has used SR. Overall, for policies where SR was used, 21% of SR supported the clinical usage of the drug and imparted high impact on 33% of policies. A maximum 39% of Aetna and minimum 13% of the Anthem oncology drug medical policies used SR as evidence while Cigna and UHG have not used SR as supporting evidence for oncology drugs. Conclusions: Cochrane SR used to inform oncology therapy was quite a low. Scope persists to improve the usage of Cochrane SR to inform the payer policies of oncology drugs. No conflict of interest. 1085 POSTER Patients’ guardians, Practitioners and Population (3Ps) opinions in pediatric oncology clinical trials in developing country: a cross-sectional survey W.M. Rashed1,2 . 1 Children’s Cancer Hospital Egypt 57357, Research, Cairo, Egypt; 2 Armed Forces College of Medicine, Cairo, Egypt Background: Clinical Trials is the heart of clinical research. Pediatric cancer patients needs this type of research to improve survival especially in developing countries. The aims of this study are (1) Evaluate the public attitude toward the concept of clinical trials in general and in pediatric settings particularly, (2) Determine the most common barriers or challenges
Poster Session, Sunday 29 January 2017 that face pediatric oncologists to participate in clinical trials in Egypt taking oncologists of Children’s Cancer Hospital Egypt-57357 [CCHE] as an example, (3) Determine the most common rationale/reasons of patients’ guardian to agree or not agree to participate in clinical trials. Materials and Methods: A cross-sectional survey was carried out in three participants categories: Patients’ guardians, Practitioners and Population. Well-structured survey was used for each category. Twenty oncology physicians were contacted, One sixty five of patients’ guardian were contacted and five hundred and two from public were contacted. Results: 50% of participated oncologist were a member in clinical trial studies. They are aware about the role of ethics committee. Participated oncologists referred the importance of running a clinical trial to many reasons: progress of science and medicine (95%), patients’ recovery (85%), academic reasons (80%) and economic reasons (35%). Regarding barriers of logistic difficulties: unaware of trials opening for accrual (75%), inadequate physician commitment (35%), financial constraints (30%), lack of experienced research staff (30%), type of practice [public vs private] (25%), difficulty with ethics requirements (20%). Barriers due to personal difficulties: Overall [too much time and effort] (45%), lack of acknowledgement (40%), preference for a particular treatment (30%), Too many tests (25%), effect of doctor–patient relationship (15%), discomfort with randomization (15%), opinion of referring doctor (15%), difficulty with informed consent procedures (10%) and “patients treated like guinea pigs” (10%). From public filled the survey, more than three quarter of those participants were of university education level or higher (86.8%). 30.8% of them had children and 85.5% agreed that clinical trial is useful but only 50% agreed to participate in cancer clinical trials. Out of 164 patients’ guardians participating in this survey, 33.5% agreed to participate in clinical trials with specific rationales to participate. Conclusion: This is the first cross-sectional study on opinions regarding clinical trials in Egypt. Based on the results of this study, we will work on the barriers and put action plan and blueprint for clinical trials unit [CTU] in the research department at CCHE enhancing national and international collaboration in clinical trials especially one quarter of pediatric cancer patients in Egypt admitted to CCHE that is helpful number in large studies to improve survival according to our mission. No conflict of interest. 1086 POSTER Identification and critical analysis of metastatic breast cancer policies to advance access to care and treatment in Europe: Research methodology and approaches used to survey the current policy environment M. Thrift-Perry1 , S. Dharssi1 . 1 Pfizer, Inc. Corporate Affairs, New York, NY 10017, USA Background: The European oncology policy landscape is rapidly evolving, evidenced by the increased awareness and prioritization of National Cancer Control Plans (NCCPs), which emphasize prevention, early detection, and treatment of common cancers, such as breast cancer. While multistakeholder efforts have helped to address the needs of early breast cancer patients, there is currently limited policy engagement by governments, healthcare professionals, and patient advocacy groups to address mBC patient care and treatment challenges. The growing burden of breast cancers, many of which are detected at later stages in low- and middleincome European countries, necessitates that these countries prioritize and implement effective policies that address this urgent public health issue. Aim: To increase the understanding of the European metastatic breast cancer (mBC) policy landscape and identify opportunities to improve patient access to care and treatment. Methods: To evaluate the current policy environment across the mBC care continuum, a comprehensive analysis of existing NCCPs and public health policies and programs was conducted in 7 European countries: Sweden, Poland, France, England, Netherlands, Italy & Germany. To identify key needs and best practices in mBC treatment and care policy, specific criteria were evaluated at each stage of the mBC patient care continuum agnostic to geography. Criteria were rated as low, medium, or high based on the level of policy development in each country. These findings were further informed by regional stakeholder insights and measured against current government policies and non-governmental organizations (NGOs; eg, advocacy engagements). The compiled data provide country-specific evaluations of each mBC criteria along the care continuum. Countries were then segmented based on government engagement, policy development, and NGO activity across the care continuum. Importantly, this characterization of countries strives to improve the implementation of mBC policy through the functional application of the findings to countries not included in the original analysis, as well as through the sharing of best practices.
Abstracts
obtained from the original questionnaire used to describe nurses’ selfefficacy of their sensitive outcomes in five domains (i.e. health promotions; daily activities interferences; ancillary outcomes; avoid dangers; learning outcomes) where only items related to cancer patients cardiotoxicity effects were used (n = 15). The items rated on a five-point response scale (1 = completely no confidence; 5 = completely confidence). Results: Nurses showed an overall low self-efficacy related to their sensitive outcomes in managing cancer patients cardiotoxicity effects (mean = 3.1±0.47). There was a slight positive correlation between age and self-efficacy (r = +0.271; p-value = 0.021), therefore experienced nurses reported higher self-efficacy level. Furthermore, the cancer nurses with a post-graduate education (n = 38) had higher self-efficacy scoring (r = +0.314; p-value = 0.003). Scores were not significantly different among hospitals (p-value >0.05). The items with the higher scoring were related to the patients’ education while the items with the lower scoring were related to the monitoring and understanding of cardiotoxicity effects. Besides, the analyzed items showed a good internal consistency (Cronbach’s a = 0.88). Conclusions: Although this study has several limitations mainly related to the data collection (self-report measurement), the findings could be very useful to plane a tailored education for cancer nurses, considering how the nurses self-efficacy responses show a general low confidence to face with cardiotoxicity effects. Moreover, some important relations need to be further explored, especially regarding the age, the gender, and the education differences. Indeed, tailored educational path for cancer nurses have to be developed. No conflict of interest. 1084 POSTER Use of Cochrane evidence in supporting medical policies of oncology drugs in the United States S. Hussain1 , A.K. Najmi2 , A. Singh3 . 1 Jamia Hamdard- Hamdard University, Department of Pharmacology- Pharmaceutical Medicine, New Delhi, India; 2 Jamia Hamdard- Hamdard University, Department of Pharmacology, New Delhi, India; 3 Anna University, Department of Biotechnology, Chennai, India Background: Cancer is the second leading cause of mortality in the US. Treatment of cancer imposes an enormous economic burden on US private payers. Private payer medical policies are developed using published clinical evidence. The systematic reviews (SR) are considered as the highest quality evidence and are used to inform the clinical guideline and medical policies. Cochrane collaboration develops SR to inform healthcare decisions making. This study assesses the influence of Cochrane SR on the private payers medical policies of the drugs used for the treatment of cancer. Method: The publically available medical policy documents of the drugs used for the treatment of cancer were scanned for the top four private insurers from the US, which together cover half of the US market, namely: UnitedHealthcare (UHG), Anthem, Aetna, and Cigna. The Cochrane SR used to inform these policy documents were identified by hand-searching. The relevant information such as the use of Cochrane SR, number of SR used, context of use of SR, Impact of SR on policy, Cochrane review group and center to which SR belongs, and other data were extracted from each of the policy document. Results: A total of 39 SR were used to inform 54 policy documents of the oncology therapies. Less than a quarter (22%) of policy documents of oncology drugs of US private payers has used SR. Overall, for policies where SR was used, 21% of SR supported the clinical usage of the drug and imparted high impact on 33% of policies. A maximum 39% of Aetna and minimum 13% of the Anthem oncology drug medical policies used SR as evidence while Cigna and UHG have not used SR as supporting evidence for oncology drugs. Conclusions: Cochrane SR used to inform oncology therapy was quite a low. Scope persists to improve the usage of Cochrane SR to inform the payer policies of oncology drugs. No conflict of interest. 1085 POSTER Patients’ guardians, Practitioners and Population (3Ps) opinions in pediatric oncology clinical trials in developing country: a cross-sectional survey W.M. Rashed1,2 . 1 Children’s Cancer Hospital Egypt 57357, Research, Cairo, Egypt; 2 Armed Forces College of Medicine, Cairo, Egypt Background: Clinical Trials is the heart of clinical research. Pediatric cancer patients needs this type of research to improve survival especially in developing countries. The aims of this study are (1) Evaluate the public attitude toward the concept of clinical trials in general and in pediatric settings particularly, (2) Determine the most common barriers or challenges
Poster Session, Sunday 29 January 2017 that face pediatric oncologists to participate in clinical trials in Egypt taking oncologists of Children’s Cancer Hospital Egypt-57357 [CCHE] as an example, (3) Determine the most common rationale/reasons of patients’ guardian to agree or not agree to participate in clinical trials. Materials and Methods: A cross-sectional survey was carried out in three participants categories: Patients’ guardians, Practitioners and Population. Well-structured survey was used for each category. Twenty oncology physicians were contacted, One sixty five of patients’ guardian were contacted and five hundred and two from public were contacted. Results: 50% of participated oncologist were a member in clinical trial studies. They are aware about the role of ethics committee. Participated oncologists referred the importance of running a clinical trial to many reasons: progress of science and medicine (95%), patients’ recovery (85%), academic reasons (80%) and economic reasons (35%). Regarding barriers of logistic difficulties: unaware of trials opening for accrual (75%), inadequate physician commitment (35%), financial constraints (30%), lack of experienced research staff (30%), type of practice [public vs private] (25%), difficulty with ethics requirements (20%). Barriers due to personal difficulties: Overall [too much time and effort] (45%), lack of acknowledgement (40%), preference for a particular treatment (30%), Too many tests (25%), effect of doctor–patient relationship (15%), discomfort with randomization (15%), opinion of referring doctor (15%), difficulty with informed consent procedures (10%) and “patients treated like guinea pigs” (10%). From public filled the survey, more than three quarter of those participants were of university education level or higher (86.8%). 30.8% of them had children and 85.5% agreed that clinical trial is useful but only 50% agreed to participate in cancer clinical trials. Out of 164 patients’ guardians participating in this survey, 33.5% agreed to participate in clinical trials with specific rationales to participate. Conclusion: This is the first cross-sectional study on opinions regarding clinical trials in Egypt. Based on the results of this study, we will work on the barriers and put action plan and blueprint for clinical trials unit [CTU] in the research department at CCHE enhancing national and international collaboration in clinical trials especially one quarter of pediatric cancer patients in Egypt admitted to CCHE that is helpful number in large studies to improve survival according to our mission. No conflict of interest. 1086 POSTER Identification and critical analysis of metastatic breast cancer policies to advance access to care and treatment in Europe: Research methodology and approaches used to survey the current policy environment M. Thrift-Perry1 , S. Dharssi1 . 1 Pfizer, Inc. Corporate Affairs, New York, NY 10017, USA Background: The European oncology policy landscape is rapidly evolving, evidenced by the increased awareness and prioritization of National Cancer Control Plans (NCCPs), which emphasize prevention, early detection, and treatment of common cancers, such as breast cancer. While multistakeholder efforts have helped to address the needs of early breast cancer patients, there is currently limited policy engagement by governments, healthcare professionals, and patient advocacy groups to address mBC patient care and treatment challenges. The growing burden of breast cancers, many of which are detected at later stages in low- and middleincome European countries, necessitates that these countries prioritize and implement effective policies that address this urgent public health issue. Aim: To increase the understanding of the European metastatic breast cancer (mBC) policy landscape and identify opportunities to improve patient access to care and treatment. Methods: To evaluate the current policy environment across the mBC care continuum, a comprehensive analysis of existing NCCPs and public health policies and programs was conducted in 7 European countries: Sweden, Poland, France, England, Netherlands, Italy & Germany. To identify key needs and best practices in mBC treatment and care policy, specific criteria were evaluated at each stage of the mBC patient care continuum agnostic to geography. Criteria were rated as low, medium, or high based on the level of policy development in each country. These findings were further informed by regional stakeholder insights and measured against current government policies and non-governmental organizations (NGOs; eg, advocacy engagements). The compiled data provide country-specific evaluations of each mBC criteria along the care continuum. Countries were then segmented based on government engagement, policy development, and NGO activity across the care continuum. Importantly, this characterization of countries strives to improve the implementation of mBC policy through the functional application of the findings to countries not included in the original analysis, as well as through the sharing of best practices.