Health Research Areas, Approaches & Objectives Cheat Sheet

Health Research Areas Approaches Cheat Sheetcommon Objectives Design

Health Research Areas & Approaches Cheat Sheet Common objectives Design & outcomes Setting / organizational involvement Other aspects Links to more information 1. Epidemiological research Studies are often concerned with identifying factors related to disease burden and transmission within a population Studies employ observational designs, using dichotomized data to calculate outcomes such as disease risk, incidence, and odds Research may be conducted by academic, government, or hospital-based investigators. Investigators often have less control over an intervention, and instead are analyzing surveillance data and/or data related to “natural experiments” BRFSS, NHANES, and NHIS are health surveillance programs collecting data that are often used in epidemiology studies. This data is publicly available.

2. Health service research This area of research is concerned with how outcomes are related to health system structures and processes. Studies may be focused on issues related to the “triple aim” of improving quality of care and patient experience, and decreasing costs, and are often concerned with understanding issues related to delivery of health services May rely on a combination of clinical, patient reported, and economic metrics, using experimental and quasi- experimental designs Typically conducted in hospital and health system settings. May involve collaboration between academic institutions and health systems, and potentially rely on collaboration and data sharing across large networks of health systems and academic institutions. May evaluate programs or initiatives implemented at specific practices, but often with a greater emphasis on external validity / generalizability than would be the case in classic program evaluation NIH RePORTER is a registry of federally funded studies, including many health service studies (also includes clinical studies) AcademyHealth is a national professional association promoting 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 treatment of disease in individual patients. Often aiming to demonstrate the efficacy of a new drug, medical device, or treatment Clinical outcomes, focus on specific biomarkers, using the “gold standard” randomized clinical trial design Typified conducted by large, multi-site studies involving hundreds or thousands of participants receiving an intervention in a clinical setting Typically involves collaborations between academic institutions, pharmaceutical companies, and other industry partners Investigators attempt to maintain 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 human subjects to studies to identify long term side effects Clinicaltrials.gov is a searchable registry of clinical trials, including results FDA.gov provides information related to running clinical trials, including regulations and oversight

4. Program evaluation Program evaluation is concerned with understanding the impact 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 outcome measures. Outcomes of interest may be clinical or patient reported. Evaluations can use any research design. Quasi-experimental designs may be used more often in evaluation than in clinical research that aims to produce generalizable findings. Program evaluation is common for health programs implemented within state or local governmental agencies, NGOs, and health organization. Evaluation differs from traditional research in its emphasis 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 programs often require an evaluation using the CDC’s evaluation framework. RE-AIM is an evaluation framework that is common to CBPR and D&I initiatives. The Donabedian Model is a framework for evaluating health service initiatives and quality of care.

5. Quality improvement (QI) Healthcare QI projects are typically focused on improving or streamlining processes related to patient care or hospital management. QI projects can use a wide range of clinical and performance-related measures. Projects can follow a “plan, do review” process rather than an experimental or quasi-experimental design (although QI projects that feature comparison groups aren’t uncommon) Healthcare organizations of all types engage in QI. QI initiatives may be championed by providers or hospital or health system management. Institute of Medicine reports - To Err is Human (1999) and Crossing the Quality Chasm (2001) played an important role in bringing issues in health quality to the fore. A distinction is often made between health research and QI projects, but the line separating the two is fuzzy and without universal consensus. IOM’s 6 Domains of Healthcare Quality provide a framework for assessing quality. Lean and Six Sigma are approaches developed in other industries that are sometimes used for QI in healthcare organizations.

6. Comparative effectiveness research (CER) Comparative effectiveness studies are designed to determine which of several treatment options is associated with the best outcomes. CER studies typically use experimental designs to explore the effects of different treatments. They tend to focus on clinical outcomes can also use patient reported outcomes and cost/utilization data. Most often conducted at academic and/or health service organizations. CER may also involve pharmaceutical firms and non-profit/NGOs as well. CER studies compare outcomes for patients in 2 or more intervention or treatment groups. They may also include a control or placebo group. Clinical trials may be designed as CER studies. NIH provides a variety of CER-related resources and information. The Dartmouth Institute is a pioneer in CER

7. Community Based Participatory Research (CBPR) CBPR is an approach to research that is focused on involving members as partiers in the entire research process. A major goal or CBPR is to insure that research findings are relevant to the communities that they are meant to benefit. CBPR can use any experimental, quasi-experimental, or qualitative approach to research, and can use a range of different outcomes. Studies take place within communities, often at organizations based in or operating in the community. CBPR usually involves a collaboration between community members and academic researchers Trust and the ability to identify and utilize existing knowledge and capacity within a community are key ingredients to successful CBPR. Academic researchers and community members must be able to work as equal partners. The Detroit Urban Research Center has a long history of CBPR partnerships to improve health in communities in Detroit, Michigan. A CBPR toolkit is available from the National Organization of Community Health Centers.

8. Patient Centered Outcomes Research (PCOR) This approach incorporates CBPR concepts into studies that often have a more clinical focus. The emphasis is on conducting health research that asks questions which are important to patients - as opposed to questions that are interesting to researchers from an academic perspective. PCOR studies focus on outcomes that are important to patients. For example, a diabetes study may emphasize improved quality of life, rather than only assessing improvements in hemoglobin A1c levels. PCOR studies can use almost any type of study design. Studies take place in clinical and community settings, and typically involve collaborations between healthcare organizations, academic institutions, and sometimes professional organizations as well. The PCOR concept has recently gained popularity among federal and private funders as a strategy to ensure that funded research studies are having a real benefit for patients. Findings are often meant to help patients make a decision between available treatment options. For that reason these studies are often set up as CER The Patient Centered Outcomes Research Institute (PCORI) was created under the ACA and has been championing this approach to research across the country. The Patient is a journal focused on publishing articles from PCOR studies.

9. Dissemination & implementation research (D&I) The aim of D&I is to study approaches for putting evidence-based treatments and interventions into practice. Since D&I studies may be more focused on process-related outcomes, since they are usually taking a treatment that has been demonstrated to be effective and understanding how to get that treatment to patients. Studies may combine a traditional experimental design with a RE-AIM style evaluation to collect data on the implementation process. D&I studies are conducted within hospital, health systems, academic institutions, community-based health organizations, large national and multinational NGOs, and so on D&I research is becoming increasingly common, and a large number of federal and private foundation granting organizations have been funding studies. It is often a multidisciplinary approach drawing from all areas of health research. TIDIRH is an institute at Washington University associated with NIH that promotes D&I research and provides trainings and resources. Implementation Science is a peer-reviewed journal dedicated to publishing findings of D&I studies.