Sir_Excellence
H e a lth R e se a rc h A re a s & A p p ro a c h e s C h e a t S h e e t Com m on objectives Design & outcom es Setting / organizational involvem ent Other aspects Links to m ore inform ation 1. Epidem iological research Studies are often concerned with identifying factors related to disease burden and transm ission within a population Studies em ploy observational designs, using dichotom ized data to calculate outcom es such as disease risk, incidence, and odds Research m ay be conducted by academ ic, governm ent, or hospital-based investigators. Investigators often have less control over an intervention, and instead are analyzing surveillance data and/or data related to “natural experim ents” BRFSS, NHANES, and NHIS are health surveillance program s collecting data that are often used in epidem iology studies. This data is publicly available. 2. H ealth service research This area of research is concerned with how outcom es are related to health system structures and processes. Studies m ay be focused on issues related to the “triple aim ” of im proving quality of care and patient experience, and decreasing costs, and are often concerned with understanding issues related to delivery of health services M ay rely on a com bination of clinical, patient reported, and econom ic m etrics, using experim ental and quasi- experim ental designs Typically conducted in hospital and health system settings. M ay involve collaboration between academ ic institutions and health system s, and potentially rely on collaboration and data sharing across large networks of health system s and academ ic institutions. M ay evaluate program s or initiatives im plem ented at specific practices, but often with a greater em phasis on external validity/generalizability than would be the case in classic program evaluation NIH RePORTER is a registry of federally funded studies, including m any health service studies (also includes clinical studies) Academ yHealth is a national professional association prom oting the field of health service research 3. Clinical trials These Studies are usually conducted at clinical settings and (inpatient or outpatient) focused on strategies for prevention, diagnosis, or treatm ent of disease in individual patients. Often aim ing to dem onstrate the efficacy of a new drug, m edical device, or treatm ent Clinical outcom es, focus on specific biom arkers, using the the “gold standard” random ized clinical trial design Typified conducted by large, m ulti-site studies involving hundreds or thousands of participants receiving an intervention in a clinical setting Typically involves collaborations between academ ic institutions, pharm aceutical com panies, and other industry partners Investigators attem pt to m aintain a high degree of control over the intervention’s delivery. Clinical trials are regulated in the US by the FDA, and carried out over four phases - from initial testing on hum an subjects to studies to identify long term side effects Clinicaltrials.gov is a searchable registry of clinical trials, including results FDA.gov provides inform ation related to running clinical trials, including regulations and oversight Objectives Design & outcom es Setting / organizational Other aspects Links to m ore inform ation involvem ent 4. Program evaluation Program evaluation is concerned with understanding the im pact of a specific program in a specific context, and therefore is less concerned with generalizability of findings. Program evaluation can focus on process and/or outcom e m easures. Outcom es of interest m ay be clinical or patient reported. Evaluations can use any research design. Quasi-experim ental designs m ay be used m ore often in evaluation than in clinical research that aim s to produce generalizable findings. Program evaluation is com m on for health program s im plem ented within state or local governm ental agencies, NGOs, and health organization. Evaluation differs from traditional research in its em phasis on a specific program and context. Findings are generally geared toward helping stakeholders involved in a program to understand whether objectives are being achieved The CDC provides a wealth of evaluation-related resources. CDC-funded public health program s often require an evaluation using the CDC’s evaluation fram ework. RE-AIM is an evaluation fram ework that is com m on to CBPR and D&I initiatives. The Donabedian M odel is a fram ework for evaluating health service initiatives and quality of care. 5. Q uality im provem ent (Q I) Healthcare QI projects are typically focused on im proving or stream lining processes related to patient care or hospital m anagem ent. QI projects can use a wide range of clinical and perform ance-related m easures. Projects can follow a “plan, do review” process rather than an experim ental or quasi-experim ental design (although QI projects that feature com parison groups aren’t uncom m on) Health care organizations of all types engage in QI. QI initiatives m ay be cham pioned by providers or hospital or health system m anagem ent. 2 Institute of M edicine reports - To Err is Hum an (1999) and Crossing the Quality Chasm (2001) played an im portant role in bringing issues in health quality to the fore. A distinction is often m ade between health research and QI projects, but the line separating the two is fuzzy and without universal consensus. IOM ’s 6 Dom ains of Healthcare Quality provide a fram ework for assessing quality. Lean and Six Sigm a are approaches developed in other industries that are som etim es used for QI in healthcare organizations.. 6. Com parative effectiveness research (CER) Com parative effectiveness studies are designed to determ ine which of several treatm ent options is associated with the best outcom es. CER studies typically use experim ental designs to explore the effects of different treatm ents. They tend to focus on clinical outcom es can also use patient reported outcom es and cost/utilization data. M ost often conducted at academ ic and/or health service organizations. CER m ay also involve pharm aceutical firm s and non-profit/NGOs as well. CER studies com pare outcom es for patients in 2 or m ore intervention or treatm ent groups.They m ay also include a control or placebo group. Clinical trials m ay be designed as CER studies. NIH provides a variety of CER-related resources and inform ation. The Dartm outh Institute is a pioneer in CER Objectives Design & outcom es Setting / organizational involvem ent Other aspects Links to m ore inform ation 7. Com m unity Based Participatory Research (CBPR) CBPR is an approach to research that is focused on involving m em bers as partiers in the entire research process. A m ajor goal or CBPR is to insure that research findings are relevant to the com m unities that they are m eant to benefit. CBPR can use any experim ental, quasi-experim ental, or qualitative approach to research, and can use a range of different outcom es. Studies take place within com m unities, often at organizations based in or operating in the com m unity. CBPR usually involves a collaboration between com m unity m em bers and academ ic researchers Trust and the ability to identify and utilize existing knowledge and capacity within a com m unity are key ingredients to successful CBPR. Academ ic researchers and com m unity m em bers m ust be able to work as equal partners. The Detroit Urban Research Center has a long history of CBPR partnerships to im prove health in com m unities in Detroit, M ichigan. A CBPR toolkit is available from the National Organization of Com m unity Health Centers. 8. Patient Centered O utcom es Research (PCO R) This approach incorporates CBPR concepts into studies that often have a m ore clinical focus. The em phasis is on conducting health research that asks questions which are im portant to patients - as opposed to questions that are interesting to researchers from an academ ic perspective. PCOR studies focus on outcom es that are im portant to patients. For exam ple, a diabetes study m ay em phasize im proved quality of life, rather than only assessing im provem ents in hem oglobin A1c levels. PCOR studies can use alm ost any type of study design. Studies take place in clinical and com m unity settings, and typically involve collaborations between healthcare organizations, academ ic institutions, and som etim es professional organizations as well. The PCOR concept has recently gained popularity am ong federal and private funders as a strategy to ensure that funded research studies are having a real benefit for patients. Findings are often m eant to help patients m ake a decision between available treatm ent options. For that reason these studies are often set up as CER The Patient Centered Outcom es Research Institute (PCORI) was created under the ACA and has been cham pioning this approach to research across the country. The Patient is a journal focused on publishing articles from PCOR studies 9. D issem ination & im plem entation research (D & I) The aim of D&I is to study approaches for putting evidence-based treatm ents and interventions into practice. Since D&I studies m ay be m ore focused on process-related outcom es, since they are usually taking a treatm ent that has been dem onstrated to be effective and understanding how to get that treatm ent to patients. Studies m ay com bine a traditional experim ental design with a RE-AIM style evaluation to collect data on the im plem entation process. D&I studies are conducted within hospital, health system s, academ ic institutions, com m unity-based health organizations, large national and m ultinational NGOs, and so on D&I research is becom ing increasingly com m on, and a large num ber of federal and private foundation granting organizations have been funding studies. It is often a m ultidisciplinary approach drawing from all areas of health research. TIDIRH is an institute at W ashington University associated with NIH that prom otes D&I research and provides trainings and resources. Im plem entation Science is a peer-reviewed journal dedicated to publishing findings of D&I studies
