Claire F. Snyder

63 Background: Patient engagement during the initiation, development, and implementation of a study has been shown to improve the ethical nature of research and the appropriateness of treatment methods, and insights into how best to partner with patients are needed. We describe our patient engagement experience in developing a clinical trial for non-metastatic pancreatic cancer (PCA). Methods: A team of patient research partners (PRPs) was consulted to design a multi-institutional study to evaluate the efficacy of chemotherapy, stereotactic body radiation therapy, and early palliative care (EPC) in patients with PCA who are typically ineligible for clinical trials due to advanced age, poor performance status, or preexisting comorbidities. PRPs included patients, caregivers, clinical researchers, patient advocacy organizations, and pharmaceutical companies. A 22-item initial survey on personal interests and a 5-item follow-up survey on study design were anonymously completed after two in-person meetings. Results: Of 15 PRPs involved, 9 completed the initial survey and 10 completed the follow-up survey. PRPs were most interested in improving quality of life (QOL, 89%), care coordination (78%), symptom management (67%), stress/anxiety (56%), and survival (56%). Confidence in the care team, hope, QOL, education and understanding, dignity, and pain management were reported to be the most important factors throughout the cancer experience. The majority (89%) requested that study participants have access to the study protocol and research publications supporting the study design. Because all PRPs suggested that a personal website be used to provide information to study participants and to disseminate the results of the study, an online patient education platform was adopted and customized for patients (and caregivers). Furthermore, integration of EPC into the treatment regimen was unanimously endorsed. Conclusions: Engaging PRPs in the process of designing a clinical trial for PCA appears to be feasible and valuable in identifying the study objectives most important to patients. PRPs conveyed that maintaining a good QOL is essential, and adoption of EPC in these patients should be considered.

The authors' results suggest that, when using PROs in clinical practice for patient management, the PRO measure matters in terms of usefulness to patients. The authors advise careful selection of the PRO measure best suited for the particular clinical practice application.

Patient-centered outcomes research (PCOR) aims to improve care quality and patient outcomes by providing information that patients, clinicians, and family members need regarding treatment alternatives, and emphasizing patient input to inform the research process. PCOR capitalizes on available data sources and generates new evidence to provide timely and relevant information and can be conducted using prospective data collection, disease registries, electronic medical records, aggregated results from prior research, and administrative claims. Given PCOR’s emphasis on the patient perspective, methods to incorporate patient-reported outcomes (PROs) are critical. PROs are defined by the US Food and Drug Administration as “Any report coming directly from patients… about a health condition and its treatment.” However, PROs have not routinely been collected in a way that facilitates their use in PCOR. Electronic medical records, disease registries, and administrative data have only rarely collected, or been linked to, PROs. Recent technological developments facilitate the electronic collection of PROs and linkage of PRO data, offering new opportunities for putting the patient perspective in PCOR. This paper describes the importance of and methods for using PROs for PCOR. We (1) define PROs; (2) identify how PROs can be used in PCOR and the critical role of electronic data methods for facilitating the use of PRO data in PCOR; (3) outline the challenges and key unanswered questions that need to be addressed for the routine use of PROs in PCOR; and (4) discuss policy and research interventions to accelerate the integration of PROs with clinical data.

Purpose Patient-reported outcomes (PROs) are used increasingly for individual patient management. Identifying which PRO scores require a clinician’s attention is an ongoing challenge. Previous research used a needs assessment to identify EORTC-QLQ-C30 cutoff scores representing unmet needs. This analysis attempted to replicate the previous findings in a new and larger sample. Methods This analysis used data from 408 Japanese ambulatory breast cancer patients who completed the QLQ-C30 and Supportive Care Needs Survey-Short Form-34 (SCNS-SF34). Applying the methods used previously, SCNS-SF34 item/domain scores were dichotomized as no versus some unmet need. We calculated area under the receiver operating characteristic curve (AUC) to evaluate QLQ-C30 scores’ ability to discriminate between patients with no versus some unmet need based on SCNS-SF34 items/domains. For QLQ-C30 domains with AUC ≥ 0.70, we calculated the sensitivity, specificity, and predictive value of various cutoffs for identifying unmet needs. We hypothesized that compared to our original analysis, (1) the same six QLQ-C30 domains would have AUC ≥ 0.70, (2) the same SCNS-SF34 items would be best discriminated by QLQ-C30 scores, and (3) the sensitivity and specificity of our original cutoff scores would be supported. Results The findings from our original analysis were supported. The same six domains with AUC ≥ 0.70 in the original analysis had AUC ≥ 0.70 in this new sample, and the same SCNS-SF34 item was best discriminated by QLQ-C30 scores. Cutoff scores were identified with sensitivity ≥0.84 and specificity ≥0.54. Conclusion Given these findings’ concordance with our previous analysis, these QLQ-C30 cutoffs could be implemented in clinical practice and their usefulness evaluated.

Purpose: Building on previous research documenting differences in preventive care quality between cancer survivors and noncancer controls, this study examines comorbid condition care. Methods: Using data from the Surveillance, Epidemiology, and End Results (SEER) –Medicare database, we examined comorbid condition quality of care in patients with locoregional breast, prostate, or colorectal cancer diagnosed in 2004 who were age ≥ 66 years at diagnosis, who had survived ≥ 3 years, and who were enrolled in fee-for-service Medicare. Controls were frequency matched to cases on age, sex, race, and region. Quality of care was assessed from day 366 through day 1,095 postdiagnosis using published indicators of chronic (n = 10) and acute (n = 19) condition care. The proportion of eligible cancer survivors and controls who received recommended care was compared by using Fisher's exact tests. The chronic and acute indicators, respectively, were then combined into single logistic regression models for each cancer type to compare survivors' care receipt to that of controls, adjusting for clinical and sociodemographic variables and controlling for within-patient variation. Results: The sample matched 8,661 cancer survivors to 17,322 controls (mean age, 75 years; 65% male; 85% white). Colorectal cancer survivors were less likely than controls to receive appropriate care on both the chronic (odds ratio [OR], 0.88; 95% CI, 0.81 to 0.95) and acute (OR, 0.72; 95% CI, 0.61 to 0.85) indicators. Prostate cancer survivors were more likely to receive appropriate chronic care (OR, 1.28; 95% CI, 1.19 to 1.38) but less likely to receive quality acute care (OR, 0.75; 95% CI, 0.65 to 0.87). Breast cancer survivors received care equivalent to controls on both the chronic (OR, 1.06; 95% CI, 0.96 to 1.17) and acute (OR, 0.92; 95% CI, 0.76 to 1.13) indicators. Conclusion: Because we found differences by cancer type, research exploring factors associated with these differences in care quality is needed.

While clinical care is frequently directed at making patients “feel better,” patients’ reports on their functioning and well-being (patient-reported outcomes [PROs]) are rarely collected in routine clinical practice. The International Society for Quality of Life Research (ISOQOL) has developed a User’s Guide for Implementing Patient-Reported Outcomes Assessment in Clinical Practice. This paper summarizes the key issues from the User’s Guide. Using the literature, an ISOQOL team outlined considerations for using PROs in clinical practice; options for designing the intervention; and strengths, weaknesses, and resource requirements associated with each option. Implementing routine PRO assessment involves a number of methodological and practical decisions, including (1) identifying the goals for collecting PROs in clinical practice, (2) selecting the patients, setting, and timing of assessments, (3) determining which questionnaire(s) to use, (4) choosing a mode for administering and scoring the questionnaire, (5) designing processes for reporting results, (6) identifying aids to facilitate score interpretation, (7) developing strategies for responding to issues identified by the questionnaires, and (8) evaluating the impact of the PRO intervention on the practice. Integrating PROs in clinical practice has the potential to enhance patient-centered care. The online version of the User’s Guide will be updated periodically.

Patient-centered care is an important aspect of high-quality care. Health informatics, particularly advances in technology, has the potential to facilitate, or detract from, patient-centered cancer care. Informatics can provide a mechanism for patients to provide their clinician(s) with critical information and to share information with family, friends, and other patients. This information may enable patients to exert greater control over their own care. Clinicians may use information systems (e.g., electronic medical records) to coordinate care and share information with other clinicians. Patients and clinicians may use communication tools and information resources to interact with one another in new ways. Caution in using new information resources is warranted to avoid reliance on biased or inappropriate data, and clinicians may need to direct patients to appropriate information resources. Perhaps the greatest challenge for both patients and providers is identifying information that is high quality and that enhances (and does not impede) their interactions.