Treating the Individual: The Intersection of Personalized Medicine and Clinical Pathways

In a panel session at the 2023 Clinical Pathways Congress + Cancer Care Business Exchange, Ray Page, DO, PhD, The Center for Cancer and Blood Disorders, discussed how personalized medicine and clinical pathways intersect in ways that help drive the best outcomes for patients. In addition, co-presenters Mary E. Cooley, PhD, RN, FAAN, Dana-Farber Cancer Institute, and David F. Lobach, MD, PhD, MS, Elimu Informatics, provided an overview of their work on clinical decision-support tools for management of uncontrolled cancer symptoms.

According to Dr Page, about 15-20 years ago clinical pathways were less complicated. The introduction of molecular diagnostics and precision medicine has made treatment more complex. “There’s a proliferation of disease states and pathways,” he said. For example, with lung cancer there are at least 13 molecular targets depending on the mutation status, PDL-1 status, and whether immunotherapy will be provided at certain periods of time. As a result, this creates more “branches” that interact, which makes the development and maintenance of pathways much more of a challenge.

Pathways vendors, payers, patients, next-generation sequencing (NGS), and molecular diagnostics “collide” to combine pathways and precision medicine. A study by Mason et al, cited by Dr Page, used clinical pathways to investigate biomarker testing patterns for patients with non–small cell lung cancer (NSCLC) among providers using clinical pathways (J Clin Pathw. 2018;4[1]:49-54. doi:10.25270/jcp.2018.02.00001). The researchers found that these providers had high biomarker testing rates (94%), and 96.8% of patients had been prescribed the appropriate treatment. The remaining 3.2% of patients were enrolled in a clinical trial, and those with PDL-1 expression greater than 50% received immunotherapy (87.1%). Overall, the study showed that providers can use clinical pathways as a tool to promote testing of key biomarkers and assist with the selection of subsequent therapy for patients.

Dr Page concluded his section of the panel by offering some solutions for precision medicine–based pathways integration into value-based care. He suggested that providers should optimize the integration of the electronic health record (EHR) with their pathways. “We need to work on better, automated AI tools to drive pathways for us,” he said. In addition, Dr Page emphasized a need for providers to better collaborate and coordinate with pharmacy, especially in the case of biosimilars in both treatment and supportive care drugs. He also stated that molecular diagnostics companies can be of greater assistance by having better communication with EHR vendors, prescreening clinical trials for novel therapies, creating “clean and free” communication with payers, and reducing administrative burdens such as preauthorization.

Dr Cooley began the second part of the session with an overview of clinical decision support (CDS) and why it is an important aspect of symptom management. According to a study by Osheroff et al, “CDS provides clinicians, staff, patients, or other individuals with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care” (J Am Med Inform Assoc. 2007;14:141-145. doi:10.1197/jamia.M2334). Some examples of CDS tools are alerts, order sets, and reminders. Currently, Dr Cooley and colleagues are pushing to make CDS more patient-centered.

Dr Cooley states that although clinical guidelines are available and can enhance symptom management, they are often not used because they are not readily available for practice line of care; they are also often provided in paper versions, which are difficult to use. Furthermore, on average clinical guidelines take about 5 years to be adopted into practice.

CDS systems that use guideline-based symptom management pathways may help with the dissemination and adherence of guidelines, according to Dr Cooley. McCleary et al and Kawamoto et al found that the implementation of certain features in CDS systems improves their impact (JAMIA Open. 2022;5[3]:ooac064. doi:10.1093/jamiaopen/ooac064; BMJ. 2005;330[7494]:765. doi:10.1136/bmj.38398.500764.8F). These features include engaging stakeholders (including patients, clinicians, and clinical staff) through the development and deployment of the systems; integrating CDS into daily workflow; providing specific recommendations at the time and location of decision-making; and providing ongoing computer-based support.

Dr Lobach provided an example of a patient app CDS tool that Elimu Informatics in collaboration with the Dana Farber Institute have been developing for 20 years. He stated that the goal of the project was “to build a standards-based, interoperable EHR-integrated CDS system addressing 9 common symptoms: fatigue, pain, constipation, depression, anxiety, insomnia, nausea/vomiting, diarrhea, and skin reactions.” He then proceeded to walk through the patient experience when using the app.

The patients receive a text message that invites them to complete a questionnaire. This is how providers are able to engage with the patients. The survey collects data from the patients and continues to do so by prompting with optional questions to provide further details and context of the patient’s situation. Severe symptoms are tagged, and treatments they’ve already tried are removed as options for treatment. The app combines patient-reported information and EHR data, which are processed through complex decision algorithms that generate patient-tailored guidance. The clinician can use this information to select a management recommendation, and patients are also educated in the process. In order to have successful patient engagement, Dr Lobach recommends that future developments of similar CDS tools be intuitive so that patients should not need additional assistance or instruction.