Patients and caregivers can impact research quality throughout the research process.  As discussed below, their feedback, submitted through The Research Loop can shape all areas of research including design, data, and analysis and interpretation. Feedback in all of these areas may also give research greater validity12,15,30,31 and applicability.9

a. Design

Research design can make or break a study’s success.  As Chalmers & Glasziou noted, a main driver of research waste is the “poor engagement of end users of research” in design.24  They further pointed out that “New research is also too often wasteful because of inadequate attention to…important elements of study design”24

The voice of patients and caregivers can improve design in various ways.  They can ensure that design focuses on identified priorities that are relevant to patients.  They can make sure that research questions and outcomes are clear and point to inadequate descriptions.24,32,33 They can assess a study’s feasibility and barriers to recruitment.10,23,33 They can help identify choice of methods for trials.33 They can help develop research tools including rewriting documents in more accessible language.33 And they can reveal any biases or assumptions researchers may have that could influence the research. 

As discussed above, barriers to including patients and caregivers mean they are not able to be on the initial design team.  Yet, their critical eye can retrospectively review the design of published research. With The Research Loop, patients and caregivers can offer feedback on the design choices made by researchers.  This feedback can push researchers to evaluate why they made certain design choices and how that might have affected their results.  The feedback can help researchers focus on priorities important to patients and caregivers and define better research questions.  Additionally, patients and caregivers can suggest design improvements or new directions.  In so doing, patients and caregivers can provide important input to shape future research studies.

b. Data

Traditionally, patients and caregivers have not had access to data sets and thus have been all but excluded from this aspect of the research process. Occasionally, researchers have asked patients and caregivers to assist with data collection or allow them to be part of a research team.  More often though, patients and caregivers are only seen as data points – a passive role – rather than active collaborators in this stage. 

Movements to compel researchers to share data with each other and with patients and caregivers are growing more and more each day. These efforts are in their infancy but have important backing from patient leaders who recognize the value patients and caregivers can add to research if data is available to them.

Even without fully published data sets, patients and caregivers can still take a minimal part in this part of the research process.  For instance, patients and caregivers can identify where the presentation of data in a paper is unclear.  According to Glasziou, “31% of all graphs published in the Journal of the American Medical Association in 1999 and 2000 could not be interpreted unambiguously because some features were not self-explanatory.”34  While this statistic may have changed over the years, many patients and caregivers find research intellectually inaccessible precisely because the data is not intuitively presented.  Involvement by patients and caregivers in this respect can result in “reporting [that is] more meaningful and understandable for participants and the community.”9

Patients and caregivers offering feedback through The Research Loop can similarly comment on tables and graphs and the data available.  They can also comment on which statistical analysis methods the researcher chose and data points the researcher failed to include in their study.  For instance, a study that misses important demographic or socioeconomic data that could inform their findings and provide context.14 They can question what values the researcher deemed significant and ask the researcher to consider future studies that takes these views into account.

With this feedback in hand, researchers can consider what data they will collect in future studies, what methods for data collection and statistical tests they may use, and develop outputs and graphs that are more accessible and relevant to the public.

c. Analysis and Interpretation

According to INVOLVE, the patient and caregiver voice in analysis and interpretation can “help to identify themes that researchers might miss, help in checking the validity of the conclusions from a public perspective, and highlight findings that are more relevant to the public.”  In fact, Shippee et al. found, including patients and caregivers in analysis “resulted in an improved ability to contextualize conclusions…, added language and culture insight and highlighted [patients’ and caregivers’] priorities for a more focused analysis.”15  More importantly, patients and caregivers can point to the “appropriateness of the analysis.”

As with design and data, The Research Loop offers patients and caregivers a forum to provide critical feedback on the analysis and interpretation presented in research studies.  This may include highlighting areas where the analysis may not be focused and concise, or spotting inconsistencies in interpretation.  Additionally, patients and caregivers might again identify researcher bias. Because researchers may be removed or isolated from the actual caregiver or patient experience, they may make certain assumptions that can lead to faulty interpretations.  Those with firsthand knowledge of these topics may be the only ones able to help correct some assumptions.  They may also be the best to explain and expand upon the implications of the research.35

Feedback on analysis and interpretation can influence researchers’ future studies by encouraging them to understand the patient and caregiver perspective for interpretation.  It may also spark interest in aspects of the research not previously considered.

To download a full copy of The Research Loop White Paper or find links to other sections, including the reference section, click here.