Public Health Surveillance Systems Public health surveillance is the ongoing, systematic collection, analysis, interpretation, and dissemination of data regarding a health-related event for use in public health action to reduce morbidity and mortality and to improve health Centers for Disease Control and Prevention. Updated Guidelines for Evaluating Public Health Surveillance Systems. MMWR 2001; 50(RR13); 1-35. www.cdc.gov/mmwr/preview/mmwrhtml/rr5013al.htm Uses of Surveillance Systems measure the burden of a disease, including the identification of populations at high risk and the identification of new or emerging health concerns; monitor trends in the burden of a disease; (trends in detection) guide the planning, implementation, and evaluation of programs to prevent and control disease; evaluate public policy; detect changes in health practices and the effects of these changes; prioritize the allocation of health resources; provide a basis for epidemiologic research. From NCI’s surveillance research branch http://surveillance.cancer.gov/about/ Cancer surveillance provides a quantitative portrait of cancer and its determinants in a defined population. …. It also includes the assessment of genetic predisposition …. Cancer surveillance tells us where we are in the effort to reduce the cancer burden and also generates the observations that form the basis for cancer research and interventions for cancer prevention and control. From the Futures Report, September 2001, a collaboration among the National Cancer Institute, the National Center for Health Statistics, the Centers for Disease Control and Prevention, the American Cancer Society, and the North American Association of Central Cancer Registries. Research Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge 45 CFR 46.102(d). Downloaded 2/21/2012 from http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf Difference lies in purpose Research – generalizable • knowledge May be translated to population health • Surveillance – prevent or control disease and improve health, control a health problem in the population from which the information is gathered May generate generalizable knowledge Centers for Disease Control and Prevention. Policy on Distinguishing Public Health Research and Public Health Nonresearch. Downloaded 2/21/12 from http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-publichealth-research-nonresearch.pdf Why does it matter? Clarification of goals, questions Funding agency regulations and goals IRB Public health surveillance and research covered under different regulations Previously Identified Data Goals Monitor HP 2020 objective to increase the proportion of cancers screened Collect data demonstrating cost effectiveness of LS screening, for institutional and state funding purposes (newborn screening model) Measure identification of LS over time Data for educational/awareness purposes Promote appropriate institutional and provider practices Provide data to Medicaid/Medicare in support of coverage Previously Identified Q’s Prevalence of LS mutation in patients with various cancer types – is screening appropriate? What family history is associated with mutation? (develop screening recommendations) What is the estimated frequency of LS associated cancers? Can we confirm the prevalence of LS? What is the number of Medicaid/Medicare patients identified with LS? More Q’s … Average number of family members identified via cascade screening? What proportion test mutation positive after screening positive under various screening protocols? What proportion of individuals identified with LS do not meet Bethesda or Amsterdam criteria? What is the penetrance of LS for various cancers? Any more? Can we prioritize Q’s and goals? Examples from Michigan BRCA counseling/testing database funded by CDC All work is aligned with goals of cooperative agreement funding Clinical sites cannot access other institution’s raw data Sites can submit proposals for analyses – reviewed by MI Dept. of Community Health Staff Authorship depends on proposals, contribution to manuscript Michigan Stroke Registry and Quality Improvement Program - similar LSSN Publications/Analysis Committee Who should be on it? Clinical expertise Analytical expertise Data contributing members Non-contributing members Funding agencies Outside stakeholders How to prioritize requests/determine suitability of requests? Established priorities & criteria will be helpful LSSN Analysis Proposals Institutions will have access to their own data Should there be access to aggregate raw data (vs. results of an analysis)? Different levels of access? Who should be able to submit proposals/author papers? Contributing, non-contributing LSSN institutions? Outside investigators? Students? Will it cost $$$ to access raw or aggregate data? Authorship Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research: Authorship and Contributorship (http://www.icmje.org/ethical_1author.html) Authors should meet conditions 1, 2, and 3. Substantial contribution to conception and design, acquisition of data, or analysis and interpretation of data; AND Draft the article or revise it critically for important intellectual content; AND Give final approval of the version to be published Authorship in LSSN Based on # contributed to database? A certain number of representatives from each institution? Based on analysis proposals? (Who gets to propose analyses related to LSSN’s established questions and goals?) Limit the # of papers a LSSN member can author? What about acknowledgements? Acknowledgements Acknowledge each institution contributing data to that analysis and publication? Acknowledge individuals vs. contributing institution Just put in link to LSSN website? Or name LSSN in some other way?