69 research outputs found
Prostate Specific Antigen (PSA) Growth Curves: A Method to Improve Prostate Cancer Screening
Prostate cancer (PrCA) screening aimed at detecting aggressive disease represents a significant public health issue. Development of biomarkers to predict PrCA that is likely to kill if left untreated is a major challenge. This dissertation focused on analyzing existing repeated measures of prostatic specific antigen (PSA) to develop and validate a tool to improve both sensitivity and specificity of the PSA-based screening test to detect high-risk PrCA. We used the Prostate Lung Colorectal and Ovarian trial data (PLCO) for PSA growth model building. Using 6 years of annual PSA measurements we established the PSA growth curves for four groups of men; those who developed high-risk PrCA, those who developed low-risk PrCA, those who developed benign prostatic hyperplasia (BPH) and those who were not diagnosed with either PrCA or BPH. We used these curves to estimate PSA annual rate of change at defined time points; one and two years before diagnosis for each individual in the cohort. We then examined the area under the curve (AUC) to estimate the specificity and the sensitivity of PSA annual rate thresholds. We validated our work by replicating the PSA growth models in a cohort of screened men in The Department of Veterans Affairs. Our results show that PSA annual change rates varied significantly by cancer status in both cohorts. The difference between the means of PSA rate values across the four groups of men was high and robust. Annual individual PSA rates showed substantial variability; however, a distinct range and significantly higher values were observed among men who developed high-risk PrCA. This resulted in high AUC (0.97) in the logistic regression model. A threshold of 0.37ng/ml/year had the best combination of sensitivity and specificity; i.e., of 97.2%, and 97.3% respectively. In the VA validation cohort, the same pattern was observed. However, men in the low-risk PrCA group had higher annual PSA rates as compared to the same group in the PLCO cohort. This resulted in a lower AUC of 93.3 (92.86-93.71) and the threshold of 0.37ng/ml/year predicted high-risk PrCA with a sensitivity and specificity of 95.5% and 86.2 % retrospectively
Abstract C66: Screening via multiple PSA measures to detect virulent prostate cancer could provide a way to address fundamental issues in African-American men's health
Abstract
The dilemma facing individuals wishing to make decisions regarding prostate cancer (PrCA) screening pivots on two opposing outcomes: over-diagnosing indolent cancer and under-diagnosing virulent cancer. In conjunction with limited data on which to draw conclusions, this dilemma formed the basis on which the US Preventive Services Task Force made its decision to not recommend PSA screening. Data driving that decision-making process was derived nearly entirely from European and European-American men, even though African Americans are much more likely to be diagnosed with later-stage, more aggressive disease at younger ages. The discrepancy that we see between the US' highest-world-quintile incidence rates and second-lowest-world-quintile mortality rates may be explained entirely by the presence of high-virulence disease among African Americans.
Clearly, detecting aggressive disease represents a significant public health issue and unmet clinical need. Development and discovery of biomarkers to predict PrCA that is likely to kill if left untreated is the major challenge in PrCA prevention and control. With this background in mind we sought to interrogate a large data set with multiple PSAs measured at regular (i.e., annual) intervals to see if we could predict high-virulence PrCA. Using the PLCO data we showed that with ≥three measures we were able to improve sensitivity and specificity of the PSA test to >97% overall and >99% among African-American men for detecting virulent, clinically relevant high-risk prostate cancer (PSA level ≥ 20ng/ml, cancer that invades prostate capsule, PrCA that involves more than one lobe, or Gleason score >7).
At this juncture, we have begun to address the question of what can be done to distinguish aggressive PrCA in African-American men. We propose creating a cohort of 48,000 individuals who are willing to undergo annual PSA screening with the intention of validating/refining the algorithm that the University of South Carolina team developed using PLCO trial data that combines three or more PSA measures to detect virulent, high-risk PrCA. This cohort also would serve another important purpose. There currently exists no other cohort with a sufficient number of African-American men to address other important cancer-related health issues. So, if designed correctly, this cohort could serve numerous other purposes.
This would be a simple follow-up study design with extensive baseline data collection and follow-up data collected at regular (i.e., annual) intervals. This would require strong community buy-in, commitment to providing information needed for informed decision-making, formulating rules for referring men out for diagnostic workup, and putting procedures in place for data linkage (e.g., to the cancer registries). Twelve institutions in 10 states across the US have expressed interest in being involved.
Currently, there are two, non-mutually exclusive, options for recruitment.
The Veterans Administration (VA) system could be ideal setting for this because: 1. They already have the screening infrastructure in place; 2. There isn't the financial incentive to over-diagnose and over-treat; 3. There is an excellent system of medical records; 4. There are many African-American veterans in the VA system; and 5. The medical home (for subsequent care) already is in place.
The NCI's community oncology research program (NCORP) appears to understand the CBPR imperative. As such, they have good access to local, interested communities and in some regions of the country this includes large AA populations. They have excellent community relations and local “connectivity” that could help to ensure a competent, caring ‘medical home' that would be essential for program viability (i.e., recruitment and follow-up). Depending on geographical particulars, there could be good overlap with the VA. NCORPS could add an important element of academic medicine/ NCI imprimatur to the mix.
Citation Format: James R. Hebert, Abraham Turner, Johnny Payne, Azza Shoaibi. Screening via multiple PSA measures to detect virulent prostate cancer could provide a way to address fundamental issues in African-American men's health. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr C66.</jats:p
Assessment of services for diabetes mellitus in clinics in Ramallah, West Bank, occupied Palestinian territory: an evaluation study
Azza,Shoaibi:University of South Carolina
Rana,Khatib:Community and Public Health
Abdullatif,Husseini:Community and Public HealthBackground Diabetes mellitus is a leading cause of morbidity and mortality worldwide. Few reliable data about its
management and complication rates have been reported in the occupied Palestinian territory (oPt). Services are offered
to patients with diabetes by four main providers: Ministry of Health (MoH), UN Relief and Works Agency for Palestine
Refugees in the Near East (UNRWA), non-governmental organisations (NGOs), and the private sector. However, the
main components of their services have not been assessed systematically in the reports. Our objective therefore was to
assess the provision of services for disease management (including infrastructure and related equipment), training
needs of health-care personnel, adherence to guidelines for disease management by the clinics of the MoH, UNRWA,
and NGOs in Ramallah, West Bank, oPt, for patients with diabetes.
Methods We assessed 11 clinics in Ramallah between Jan 27 and Feb 24, 2009. Four were clinics of the MoH, three
UNRWA, one NGO, and three joint clinics of MoH and NGOs. We assessed the clinics through semistructured
interviews with the doctors, nurses, pharmacists, and laboratory technicians managing patients with diabetes;
examination of the infrastructure of the clinics, measurement of crowding, and review of one to three patients’
consultations per clinic with doctors and nurses; and review of three to five sample records per clinic to ascertain their
completeness. Consent was obtained from the various stakeholders to assess their clinics, and health professionals
working at the clinics to interview them and review the records of their patients. The aim of reviewing the records was
to assess their completeness and we did not use the names of the patients or the actual data on the record.
Findings The management guidelines and provision of services for patients with diabetes differed between providers.
Services were most centralised at MoH clinics. Insulin was provided at two clinics of MoH, one joint clinic of MoH
and NGO, and all clinics of UNRWA. All health-care personnel at the clinics of UNRWA and NGO and the joint
clinics of MoH and NGOs were trained according to their respective provider’s guidelines compared with none of
those at the clinics of MoH. Weight and height were measured and body-mass index was calculated at one clinic of
MoH, clinic of the NGO, two joint clinics of MoH and NGO, and all clinics of UNRWA. Blood pressure was measured
at three clinics of MoH, two joint clinics of MoH and NGO, clinic of NGO, and all clinics of UNRWA. Equipment for
the assessment of diabetic complications was available in some clinics but rarely used. For example, ophthalmoscopes
were available at three clinics of MoH, three joint clinics of MoH and NGO, one clinic of UNRWA, but used in one
joint clinic; visual acuity charts were available at one clinic of MoH, one joint clinic of MoH and NGO, and two clinics
of UNRWA; electrocardiogram machines were available at three clinics of MoH, three joint clinics of MoH and NGO,
two clinics of UNRWA, and clinic of the NGO, but used in one joint clinic of MoH and NGO, two clinics of UNRWA,
and clinic of the NGO; tuning forks were available in two joint clinics of MoH and NGO and two clinics of UNRWA.
Monofilament was not available in any of the clinics. Foot-care equipment was available at one UNRWA clinic but
was not used. The glycated haemoglobin A1c test was available at the clinic of the NGO and the three joint clinics of
MoH and NGO. Microalbumin test was not available at any of the clinics. A nutritionist was available at the clinic of
the NGO and one joint clinic of MoH and NGO. The consultation time with doctors and nurses at the clinics of the
MoH and UNRWA was short (3–10 min) and consultations were not individualised or recorded. Records at the clinics
of UNRWA, clinic of the NGO, and the joint clinics were better organised and more complete than were those of the
MoH clinics. These clinics had special records with complete information for patients with diabetes whereas the
clinics of MoH had different types of records with incomplete information. Monitoring of patients was more
systematic at the clinics of UNRWA and NGO and the joint clinics of MoH and NGO than at the MoH clinics. In the
clinics of UNRWA and NGO and the joint clinics of NGO and MoH, patients were given appointments and were
monitored according to the protocols in these clinics (for laboratory tests and physical examination), whereas at the
clinics of MoH an appointment system and protocols for monitoring were not used
J Hypertens
IntroductionAngiotensin receptor blockers (ARBs) are commonly used antihypertensive medication with several other additional proven benefits. Recent controversy on association of lung cancer and other solid malignancy with the use of ARBs is concerning, although the follow-up studies have shown no such association.MethodsWe used data from the Department of Veterans Affairs electronic medical record system and registries to conduct a retrospective cohort study that compared first-time ARB users with nonusers in 1:15 ratio, after balancing for many baseline differences using inverse probability of treatment weights. We conducted time-to-event survival analyses on the weighted cohort.ResultsOf the 1 229 902 patients in the analytic cohort, 346 (0.44%) of the 78 075 treated individuals had a newly incident lung cancer and 6577 (0.57%) of 1 151 826 nontreated individuals were diagnosed with lung cancer. On double robust regression, the weighted hazard ratio was 0.74 (0.67\u20130.83, P<0.0001), suggesting a lung cancer reduction effect with ARB use. There was no difference in rates by ARB subtype.ConclusionIn this large nationwide cohort of United States Veterans, we found no evidence to support any concern of increased risk of lung cancer among new users of ARBs compared with nonusers. Our findings were consistent with a protective effect of ARBs.K05 CA136975/CA/NCI NIH HHS/United StatesU48 DP001936/DP/NCCDPHP CDC HHS/United StatesU54 CA153461/CA/NCI NIH HHS/United StatesU54CA153461/CA/NCI NIH HHS/United State
A Cost Effectiveness Analysis of Salt Reduction Policies to Reduce Coronary Heart Disease in Four Eastern Mediterranean Countries
Health system challenges of cardiovascular disease and diabetes in four Eastern Mediterranean countries
This paper presents evidence from research into health system challenges of cardiovascular disease (CVD) and diabetes in four Eastern Mediterranean countries: the occupied Palestinian territory, Syria, Tunisia and Turkey. We address two questions. How has the health system in each country been conceptualised and organised to manage the provision of care for those with CVD or diabetes? And what were key concerns about the institutional ability to address this challenge? Research took place from 2009 to 2010, shortly before the political upheavals in the region, and notably in Syria and Tunisia. Data collection involved a review of key documents, interviews with key informants and brief data collection in clinics. In analysing the data, we adopted the analytical schema proposed by Walt and Gilson, distinguishing content, actors, context and process. Key findings from each country highlighted concerns about fragmented provision and a lack of coordination. Specific concerns included: the lack of patient referral pathways, functioning health information systems and investment in staff. Regarding issues underlying these visible' problems in managing these diseases, we highlight implications of the wider systemic pressure for reform of health-sector finance in each country, based on neoliberal models
Priority setting for prevention and control of coronary heart disease in the occupied Palestinian territory: a pilot study
Background The burden of coronary heart diseases is increasing at an alarming rate in most low-income and middleincome countries. The fi ndings of evidence-based studies suggest that this burden can be prevented through health
policies. Various methods to defi ne and select policies have been developed including evidence-based prioritisation,
which is important in view of the scarce resources in and data for low-income and middle-income countries. The aim
of this study was to assess and prioritise context-specifi c policies for the prevention and control of coronary heart
diseases in the occupied Palestinian territory (oPt).
Methods In this mixed-methods pilot study, a set of policy options was developed and shortlisted on the basis of
integrated fi ndings from country-specifi c qualitative situational analysis inputs and quantitative modelling of related
risk factors and treatments with the IMPACT Excel-based model. A simple Excel sheet was used to calculate a priority
score for each policy and then the policies were ranked in terms of their importance. Criteria from WHO’s prioritised
research agenda and stepwise framework were used to rate the policies. The specifi c policies were scored and
prioritised by fi ve key informants (mid-level health managers, health practitioners, and academics) from the oPt and
then ranked in terms of importance. Ethics approval to undertake the study was obtained from the Institute of
Community and Public Health, Birzeit University, Ramallah, West Bank, oPt. All participants provided verbal
informed consent.
Findings Key informants shortlisted and rated 19 polices. The top fi ve policies were population-level primary
prevention with focus on blood pressure (n=2), health-system level with focus on collaboration and capacity building
of health-care providers (n=2), and treatment for high-risk patient groups (n=1).
Interpretation Policies with focus on primary prevention and health systems indicate a good understanding of the
epidemiology of diseases and the needs of the community. However, the small number and scope of the policy makers
(directly related to health) who rated the policies in this study were limitations for improved identifi cation of evidencebased policies. This approach of ranking pre-identifi ed policies might be important for engaging policy makers and,
when there are few resources, prioritising policies
Data from: The association between method of solicitation and patient permissions for use of surplus tissues and contact for future research
Objective: Obtaining patient permissions for research contact and for surplus tissue use as part of routine clinical practice can improve research participation. This study aims to investigate the difference in patient permissions for use of surplus tissues, and for direct contact for research, using two different methods of solicitation.
Methods: An opt-in, population-based approach for gathering research permissions was implemented in two methods. The first method, applied a 2 –item patient questionnaire delivered through the EHR patient portal. The questionnaire composed of two questions 1) whether de-identified surplus specimens may be used for research) and 2) whether patients could be contacted about research. In the second method, the same questionnaire was physically presented in clinic within the clinical workflow. We used 1 to 1 propensity score matching and multivariate logistic regression to estimate the odds of obtaining permission and the difference between the two methods of solicitation.
Results: The propensity score model matched 8044 observations (4114 submissions in each group). Among the in-clinic submission group, 70.13% provided permission for surplus tissue compared to 66.65% in the patient portal submission group (OR=1.20; 95% CI 1.09-1.32; p<0.001). Permission for future research contact was similar among in-clinic (65.07%) and patient portal submission (66.65%) groups (OR=0.94; 95% CI 0.85-1.03; p=0.175). These trends were consistent among European Americans and African American patients. However, among patients of other race, higher permission for both future contact (OR=0.58; 95% CI 0.39-0.86; p<0.007) and surplus tissue use (OR=0.65; 95% CI 0.43-0.97; p=0.036) was observed among patient portal submission
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