Mayol-Heath D.N.,Research Operations |
Keck A.-S.,University of Illinois at Urbana - Champaign |
Woo P.,Carle Tissue Repository
Biopreservation and Biobanking | Year: 2011
Background research may be time consuming but is an essential component in producing a compliant, efficient, and quality biorepository. This article addresses 5 fundamental considerations associated with biorepository development. The process begins with community and stakeholder buy-in. Once this phase is complete and stakeholder approval is achieved, several crucial elements remain. When proceeding, it is important to consider researcher needs, initial facility setup requirements, start-up funding sources, biorepository site visits, regulations, and best practices. Multiple sources should be utilized when exploring these topics and should include guidance documents, regulations, existing literature, and "borrowed knowledge" from others who have been through the process. Thorough research during this initial phase and the subsequent tailoring of this information to fit the specific institution's needs will contribute significantly to the success of the biorepository. © 2011, Mary Ann Liebert, Inc.
Kamat S.A.,HealthCore Inc. |
Kamat S.A.,Research Operations |
Bullano M.F.,Astrazeneca |
Chang C.-L.,HealthCore Inc. |
And 2 more authors.
Current Medical Research and Opinion | Year: 2011
Background: Suboptimal adherence to lipid-lowering therapies is associated with and potentially contributes to increased cardiovascular morbidity and mortality. Single-pill combination (SPC) lipid-modifying therapies may improve patient adherence due to decreased pill burden and increased convenience for the patient. Objective: To compare adherence to SPC versus multi-pill combination (MPC) lipid-modifying medications. Methods: This retrospective study used pharmacy and medical claims and laboratory result data from a national managed care dataset to evaluate patients who were newly prescribed simvastatin plus ezetimibe, simvastatin plus niacin, and lovastatin plus niacin either as SPC or MPC. Patients were considered adherent to therapy if they had a proportion of days covered (PDC) â‰1 0.80. Results: The mean PDC was 0.76 and 0.70 in the first 3 months of therapy, 0.54 and 0.45 in the second 3 months, and 0.50 and 0.41 for the remaining 30 months of follow-up for the SPC and MPC groups, respectively. SPC patients were 32% (OR = 1.32; 95% CI: 1.27-1.36; P<0.01) more likely to be adherent to treatment than MPC patients. Conclusion: Adherence was significantly higher among patients receiving SPC than MPC. Although only associations and not temporality were assessed due to the observational design of this study, the use of SPC may be a successful method for improving adherence in a real-world setting. © 2011 Informa UK Ltd.
Kuter D.J.,Massachusetts General Hospital |
Macahilig C.,Research Operations |
Grotzinger K.M.,Glaxosmithkline |
Poston S.A.,Glaxosmithkline |
And 3 more authors.
International Journal of Hematology | Year: 2015
This observational study aimed to assess real-world treatment patterns and clinical outcomes for patients with chronic immune thrombocytopenia (ITP) currently being treated with eltrombopag or romiplostim after switching from corticosteroids, rituximab, or the alternate thrombopoietin receptor agonist (TPO-RA). The study examined the rationale for switching to TPO-RA therapy using aided responses. Dosing patterns were also analyzed before and after switching. Treatment outcomes were assessed through platelet counts at multiple time points including treatment initiation and after switching at the last office visit. A total of 280 patients were enrolled whose active therapy for ITP was replaced with either eltrombopag (n = 130) or romiplostim (n = 150). Efficacy-related issues (desired platelet count not achieved and/or lack of response to prior therapy) were the main drivers for therapy switching among all patients (54 % for eltrombopag vs. 57 % for romiplostim). Platelet counts at the last office visit showed improvement compared with counts at the initiation of either eltrombopag or romiplostim treatment. No significant differences were noted when comparing clinical outcomes between the eltrombopag and romiplostim treatment cohorts. Our results suggest that switching to the other TPO-RA may be beneficial if there is inadequate response to treatment with the initial TPO-RA. © 2015, The Japanese Society of Hematology.
Deepa M.,Madras Diabetes Research Foundation And Dr Mohans Diabetes Specialities Center |
Pradeepa R.,Research Operations |
Anjana R.M.,Madras Diabetes Research Foundation And Dr Mohans Diabetes Specialities Center |
Mohan V.,Madras Diabetes Research Foundation And Dr Mohans Diabetes Specialities Center
Indian Journal of Community Medicine | Year: 2011
Noncommunicable diseases (NCDs) are reaching epidemic proportions worldwide and in India. Surveillance of NCD risk factors are therefore needed as they could help in policy planning and implementation of preventive measures. This article will focus on the experiences gained, and challenges faced, in conducting NCD risk factor surveillance studies in India. Two major surveillance studies on NCDs were conducted in India - the World Health Organization (WHO) - Indian Council of Medical Research (ICMR) NCD risk factor surveillance study and the Integrated Disease Surveillance Project (IDSP). The WHO-ICMR study was a six-site pilot study representing six different geographical locations in India with a sample size of 44,537 including rural, peri-urban/slum and urban. Phase 1 of the IDSP was completed and included seven states in India with a sample size of 5000 per state. The NCD risk factor surveillance showed that high prevalence of diabetes, hypertension and obesity in urban areas with slightly lower prevalence rates in semi-urban and rural areas. There are several challenges in obtaining data on NCD risk factors, which include challenges in obtaining anthropometric and blood pressure measures and in assessing tobacco consumption, diet and physical activity. The challenges in field operations include contacting and convincing subjects, creating rapport, tracking subjects, climatic conditions, recall ability and interviewer skills. Success in surveillance studies depends on anticipating and managing these challenges. Conclusion: Improving country-level surveillance and monitoring is a valuable step in prevention and control of NCDs in India.