Appendix D: Research Questions & PICO(TS)

The Effective Health Care Program Stakeholder Guide

Comparative effectiveness reviews (CERs) are a type of systematic review, which synthesizes the available scientific evidence on the comparative effectiveness, benefits, and harms for a variety of diagnostic, treatment, and health care delivery decisions. They provide syntheses of relevant evidence to inform real-world health care decisions for consumers, clinicians, and policymakers.

CERs are designed to answer to a set of questions. The questions may be about how different tests or treatments work, or how they compare to one another. These key questions tell the researchers what to look for in the evidence. Key questions help to ensure that the research stays focused on the findings that consumers, clinicians, and health care policymakers need to make good decisions.

For example, investigators studying the evidence about different treatments available for people with acid reflux disease will engage a team of patients, clinical experts, researchers, and others to think through the important issues for people with this condition. The team then develops a list of questions that are most relevant to all consumers, clinicians, and policymakers. They will make sure the questions reflect as many of the available treatments for acid reflux disease as possible, the benefits of these treatments for different groups of people, and the possible side effects of each treatment for different groups of people.

Most typically these questions are generated during the topic refinement process. However, key questions can be suggested as part of a topic nomination. Key questions generally use a Patient, Intervention, Comparison, Outcomes, Treatment, and Setting [PICO(TS)] format to maximize the usefulness of the final report. Public comment on a set of draft key questions helps researchers continue to think about what is most important to ask so that the research report can be as useful as possible.

Patient, Population or Problem:

The "P" in PICO(TS) is a description of the patient(s) of interest. It includes the condition(s), populations or sub-populations, disease severity or stage, co-morbidities, and other patient characteristics or demographics.

Intervention or Exposure:

The "I" in PICO(TS) refers to the specific treatments or approaches with the patient or population. It includes doses, frequency, methods of administering treatments, etc.

Comparison:

The "C" in PICO(TS) describes what is being compared with the intervention described above. It includes alternatives such as placebo, drugs, surgery, lifestyle changes, etc.

Outcome:

The "O" in PICO(TS) describes the specific results of interest. It refers to short, intermediate, and long-term outcomes, and includes specific areas such as quality of life, complications, mortality, morbidity, etc.

Timing (if applicable):

The "T" in PICO(TS) describes the duration of time that is of interest for the particular patient outcome, benefit, or harm to occur (or not occur).

Setting (if applicable):

The "S" in PICO(TS) describes the setting or context of interest. Setting can be a location (such as primary, specialty, or inpatient care), or health policy that frames or restricts the important questions to be answered.

The carefully drafted questions for a CER are strengthened by incorporating stakeholders and end-users in their development. For example, patients can offer specific and important insights about the benefits and harms of a treatment or drug. Clinicians or policymakers can describe real-world treatment and coverage dilemmas that the final CER may help to resolve. These points of view are invaluable in the early phases of research and help ensure the final products are relevant and useful.

When developing key questions, investigators will use the PICO(TS) approach described above, as well as the involvement of stakeholders, to help them identify three to five specific, well-defined questions. A strong question is one that helps guide the research and can be addressed by a review of the evidence. Questions inappropriate for CER include those that involve clinical judgment, seek specific recommendations, are vague or limited to a single procedure, or that ask about general approaches to treatment.

The following examples are listed to illustrate the difference between questions that are considered "strong" or "weak" in their appropriateness for CER. Examples are listed for clinical questions, as well as the organization and delivery of health care.

Use questions that ask about indications for multiple procedures

Ask questions that are specific about effectiveness and evidence

Be specific about the aspect of health care that is of interest

Ask questions that are specific to reviewing available evidence

Ask questions that will provide a basis for determining relative performance