Reminding clinical research stakeholders to reprioritize routine assessment of patient satisfaction as a primary outcome measure in patient-centric activities.
During the past decade, there has been unprecedented focus on patient-centric initiatives in support of drug development planning and execution. The original intent of these initiatives was to amplify patient input, address patient needs and preferences, and ensure that patients have the best possible experience participating in clinical trials. As investment and experience with patient centric initiatives has evolved, a growing number of organizations have looked to measure the impact of patient-centric activities on a variety of clinical trial outcomes includingspeed and quality.1 Although these outcome measures inform project management, resource allocation and return-on-investment decisions, they are ‘trial-centric’; they are not patient centric.
Key indicators of patient experience—most notably satisfaction—are largely missing from the outcome measures that organizations are systematically gathering. Such routine assessment of patient satisfaction is essential to measuring the successful implementation of patient-centric initiatives and to informing continuous improvement of these initiatives.
The purpose of this article is to remind clinical research stakeholders to re-prioritize routine assessment of patient satisfaction as a primary outcome measure and to inform how to approach that assessment.
Patient satisfaction is not a new concept. It has been covered extensively in the medical science literature. Studies have consistently shown that there exists a positive link between patient satisfaction and a variety of patient-oriented clinical care outcomes, including in-patient mortality, treatment adherence, and improved rapport with care providers.2,3,4 Given this compelling and consistent association, it is only fitting to consistently measure and evaluate patient satisfaction.
Yet, based on a recent literature review of patient satisfaction in clinical research specifically, only a small fraction of studies (nine out of several thousand) reported systematically evaluating patient experiences during a clinical trial.5 Further, of the nine studies that reported measuring patient satisfaction, only one study used a widely accepted and validated patient satisfaction instrument (Modified Client Satisfaction Questionnaire).4 The remainder used ad hoc, investigator-developed patient satisfaction instruments.
These findings were recently corroborated at a meeting among patient engagement stakeholders from sponsor companies and contract research organizations (CRO) where the majority of companies conceded that they are not consistently measuring patient satisfaction in their clinical trials. The inconsistency and sparseness in how patient satisfaction is measured should not come as a surprise given the limited number of patient satisfaction scales developed exclusively for clinical research.
There is clearly little to no consensus on what is the most appropriate instrument for measuring patient satisfaction. This by no means suggests that organizations should be satisfied with the current state of affairs. Rather, lack of a consensus measurement-method signifies an opportunity to test out and validate different approaches for capturing patient experience in clinical research. To begin, there already exists a recognized and validated non-clinical research patient satisfaction instrument, the 8-item Modified Client Satisfaction Questionnaire. This instrument is commonly used in many different industries and has been adopted in the medical science and healthcare literature.4,6 This measure could provide an appropriate starting point from which organizations can expand and refine (i.e., adding additional questions about different aspects of the clinical research study).
There are numerous factors that impact a patient’s clinical trial experience ranging from their relationship with clinical research staff and healthcare providers to their perceptions of the research facility, location of the study site, ease or difficulty adhering to protocol requirements and the ease with which technology solutions can be used. It is important to note that the domains that are assessed are likely to change depending on the unique and custom design of each clinical trial and the unique patient population served (e.g., demographics, social determinants). Generally, it is understood that there is no one-size-fit-all-approach and this is certainly true in the endeavors to measure the patient experience. However, there still needs to be more of a unified effort and approach among sponsor and CRO companies to capture patient satisfaction across different domains covering the clinical research experience.
As a starting point, we propose the following domains:
Consistent assessment of these domains can be beneficial on many fronts. First, it can provide an important outlet for patients wishing to provide input and feedback regarding their experience. Countless studies have shown that with very few exceptions, patients eligible for clinical research studies are eager and willing to engage with researchers. A recent online survey, for example, found that the vast majority (93%) of patients would be “Interested in helping researchers design better trials.” The results suggest that protocol co-design, in particular, is an opportunity to partner and engage with patients.7
Second, examining patient attitudes and perceptions around whether they were, for example, treated with dignity and respect can provide important clues that can help inform and bolster diversity, equity, and inclusion initiatives. This is particularly important when it concerns historically marginalized groups, such as racial minorities. A recent focus group study among Black patients revealed that those treated by healthcare providers who received specialized training to treat patients of varying skin colors, reported greater respect and dignity compared to Black patients that were seen by healthcare providers who had not received such training.8 Measuring the patient experience can go a long way in revealing disparities resulting from racial, gender, and other forms of bias that could negatively affect the likelihood of a minority patient remaining in a clinical research study.
Lastly, tracking patient satisfaction can serve as an early indicator, or proxy, that can be used to help predict relevant study-level operational outcomes. For example, it is well understood that certain study-level outcomes can take a long time to collect, sometimes taking years.9 This time lag creates a challenge for stakeholders involved in the drug development process, particularly in the face of significantly rising costs to run clinical trials. Patient satisfaction, on the other hand, can be tracked and measured from the outset of a study (i.e., satisfaction level with initial interactions with study personnel). In so doing, this assessment provides relevant stakeholders with an early indicator of how patients are connecting with study personnel and experiencing participation, which can have direct, tangible effects on outcomes like recruitment rates, dropout rates, as well as patient adherence to the study drug.
Importantly, there are a variety of methodologies for administering patient satisfaction assessments while reducing patient survey fatigue and completion burden. For example, rather than ask the patient to fill out a long survey multiple times during the study, some sites could ask half of the relevant survey questions during the first few weeks or months of the study, while asking the other half of the survey questions during the second part of the study. Alternatively, some sites may ask patients to answer all of the questions at the end of the study, while some may choose to focus on a few select domains and administer the same few questions multiple times during the course of the study to examine the longitudinal impact on the patient’s experience. These are just a few examples of how the survey questions can be administered so that patients are not overly burdened but are still given an opportunity to express their personal experience and satisfaction and inform improvement. The bottom line is, there are many different ways that patient experience and satisfaction can be measured that can fit the needs of both the clinical research site executing the trial as well as the patient.
Measuring and demonstrating the impact of patient engagement in drug development remains a work-in-process. At the same time, pressure to invest in patient-centric initiatives can at times lead to what many are calling tokenistic or virtue signaling (a false appearance of inclusiveness).10,11 Left unchecked, the clinical research enterprise runs the risk of becoming more ‘trial-centric’ and of overlooking and alienating the populations that we are trying to engage, elevate, and empower.
Operational outcomes, while important, should not be the primary outcomes of patient-centric practices. Instead, they should be viewed more as key secondary endpoints that are likely to be improved as a consequence of enhanced patient satisfaction. As such, we encourage organizations to take initiative and start measuring patient experience and their attitudes about that experience. In so doing, we can empirically begin to track and demonstrate whether patient-centric initiatives are meeting the primary intent of patient engagement.
Jennifer Kim*, Tufts CSDD, Kenneth Getz, Tufts CSDD
*Corresponding Author, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 145 Harrison Avenue, Boston, MA 02111. Jennifer_y.email@example.com