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Patient Reported Outcomes Have Arrived: A Practical Overview for Clinicians in Using Patient Reported Outcomes in Oncology.

ABSTRACT: Ensuring that the patient's voice is routinely incorporated in all aspects of health care in oncology is essential to provide quality care. Patient reported outcomes (PROs) are standardized measures that are used to obtain the patient's perspective and are increasingly used in all aspects of health care to ensure optimal delivery of patient-centered care. The US Food and Drug Administration encourages that PROs be used in studies for label indications. There are no uniform standardized methods to use PROs nor is there consensus on which PROs are best for regulatory approval, comparative effectiveness research, toxicity assessment, health-related quality of life, or symptom monitoring. For this review, we conducted a literature search using PubMed and Google Scholar, and herein summarize the evidence related to the use of PROs in clinic care and research. Using valid, reliable, and easily interpretable PROs developed in comparable populations will provide the most useful results. Various ways that PROs can be used successfully in oncology have been exemplified in this overview to provide clinicians and researchers practical guidance.

SUBMITTER: Warsame R

PROVIDER: S-EPMC6832764 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Patient Reported Outcomes Have Arrived: A Practical Overview for Clinicians in Using Patient Reported Outcomes in Oncology.

Warsame Rahma R D'Souza Anita A

Mayo Clinic proceedings 20190925 11

Ensuring that the patient's voice is routinely incorporated in all aspects of health care in oncology is essential to provide quality care. Patient reported outcomes (PROs) are standardized measures that are used to obtain the patient's perspective and are increasingly used in all aspects of health care to ensure optimal delivery of patient-centered care. The US Food and Drug Administration encourages that PROs be used in studies for label indications. There are no uniform standardized methods t ...[more]

PMID: 31563425

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Project description:BACKGROUND:The value of using real-time patient-reported outcome (PRO) measures in cancer communication has gained attention both in the clinic and in research. Despite this, no internationally accepted guidelines or training programs for clinicians on how to engage in patient-centred communication based on PROs exist. Lack of training may complicate implementation and systematic use of PROs in the clinic. We aimed to develop a short and feasible manual and training session in PRO-based dialogue rooted in patient-centred communication, coined PROmunication. METHODS:PROmunication was implemented in two studies using PROs in different clinical cancer settings. We interviewed clinicians twice during the development phase. First, adopting a clinical perspective, they provided ideas for content, length and structure of the training session and the manual. Second, they approved the draft of the manual with minor adjustments on how to document clinician-patient communication. The final version of the PROmunication tool was built on clinicians' input, theory on patient-centred communication, a literature review, and didactic considerations. RESULTS:The one-page manual gave clinicians a brief and clear overview of how to prepare for, undergo and document a PRO-based consultation. Illustrations and verbal phrases were offered to operationalize and facilitate patient-centred communication. The training session included elements like evidence-based knowledge about the rationale, benefits and challenges of using PROs and comprised theory, experimental training and instructions for the use of the manual in clinical practice. Ad hoc training and feedback in the clinic followed the training session. CONCLUSIONS:This paper presents the development of a short, theory-driven manual and training session intended to support and engage clinicians in PRO-based dialogue leading to patient-centred communication. Further testing of the tool is necessary and adjustments may be required if the PROmunication tool should be applied in other clinical settings were patients are seen regularly. An evaluation of the tool is planned to be performed in future studies. Training in PROmunication may further systematic and consistent use of PRO data in the consultation, leading to patient-centred consultations and increased patient involvement.

Project description:BACKGROUND:Using a real dataset, we highlighted several major methodological issues raised by the estimation of the Minimal Clinically Important Difference (MCID) of a Patient-Reported Outcomes instrument. We especially considered the management of missing data and the use of more than two times of measurement. While inappropriate missing data management and inappropriate use of multiple time points can lead to loss of precision and/or bias in MCID estimation, these issues are almost never dealt with and require cautious considerations in the context of MCID estimation. METHODS:We used the LIGALONGO study (French Randomized Controlled Trial). We estimated MCID on the SF-36 General Health score by comparing many methods (distribution or anchor-based). Different techniques for imputation of missing data were performed (simple and multiple imputations). We also consider all measurement occasions by longitudinal modeling, and the dependence of the score difference on baseline. RESULTS:Three hundred ninety-three patients were studied. With distribution-based methods, a great variability in MCID was observed (from 3 to 26 points for improvement). Only 0.2 SD and 1/3 SD distribution methods gave MCID values consistent with anchor-based methods (from 4 to 7 points for improvement). The choice of missing data imputation technique clearly had an impact on MCID estimates. Simple imputation by mean score seemed to lead to out-of-range estimate, but as missing not at random mechanism can be hypothesized, even multiple imputations techniques can have led to an slight underestimation of MCID. Using 3 measurement occasions for improvement led to an increase in precision but lowered estimates. CONCLUSION:This practical example illustrates the substantial impact of some methodological issues that are usually never dealt with for MCID estimation. Simulation studies are needed to investigate those issues. TRIAL REGISTRATION:NCT01240772 (ClinicalTrials.gov) registered on November 15, 2010.

Project description:ObjectiveTo examine the feasibility of soliciting outcomes from adults who received chemotherapy treatment for cancer and describe the patterns and correlates of patient-reported toxicities.Data sourcesPatient survey data from 29 Michigan ambulatory oncology practices collected in 2017.Study designSecondary analysis of patient survey data. Descriptive statistics were generated at the patient and practice levels. Thematic analysis of open-text comments identified clusters of frequently reported toxicities.Data collection methodsPatients completed 11 items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. Using a 5-point Likert scale, patients rated the frequency of nausea, vomiting, diarrhea, and pain; the severity of nausea, vomiting, constipation, numbness/tingling, and pain; and how much numbness/tingling and pain interfered with usual or daily activities. Patients could also report two toxicities in open-text comments. Finally, patients reported unplanned health care service for toxicity or side effect management.Principal findingsOf 3565 eligible patients, 2245 participated (63%) and 457 (20%) rated at least one toxicity as severe/very severe. Across practices, the proportion of patients who reported at least one severe/very severe toxicity ranged from 8% to 50%. Troubling toxicities included pain frequency (mean 2.3, SD 1.3), pain severity (2.1, 1.1), and diarrhea frequency (1.9, 1.0). From completed assessments, 1653 (74%) reported at least one toxicity in open-text comments; fatigue (n = 182), stomach discomfort (n = 53), and skin/nail changes (n = 41) were most frequently reported. Regarding consequences, 156 patients (7%) reported unplanned health care service use: 41 (26%) visited an emergency department and 32 (21%) were admitted to a hospital.ConclusionsQuerying patients on chemotherapy treatment experiences and toxicities was feasible. Toxicity rates varied across practices, which informed quality improvement. Toxicity severity and service use incidence exceed previously published trial data, particularly for pain, fatigue, and gastrointestinal issues. Open-text questions enabled exploration with newer treatment regimens.

Project description:BACKGROUND:The benefits of electronic patient reported outcomes (PRO) questionnaires have been demonstrated in many settings, including in hospitals and patient homes. However, it remains to be investigated how melanoma patients and their treating clinicians experience the electronic self-reporting of side effects and the derived communication. OBJECTIVE:The primary objective of this study was to examine patients' and clinicians' experiences with an eHealth intervention for weekly monitoring of side effects during treatment with immunotherapy. METHODS:An eHealth intervention based on questions from the PRO-Common Terminology Criteria for Adverse Events (CTCAE) library was used and tested in a randomized clinical trial with patients receiving immunotherapy for malignant melanoma and clinicians at a university hospital in Denmark. On a weekly basis, patients reported their symptoms from home during the treatment via a provided tablet. The electronic patient reports were available to clinicians in the outpatient clinic. A mixed methods approach was applied to investigate the patients' and clinicians' experiences with the intervention. Data from patient experiences were collected in a short survey, the Patient Feedback Form. Moreover, a subset of the patients participating in the survey was interviewed about their experience. Furthermore, one focus group interview with clinicians was carried out to elucidate their views. RESULTS:A total of 57 patients completed the Patient Feedback Form, and 14 patients were interviewed. The focus group interview included 5 clinicians. Overall, patients and clinicians were satisfied with the tool. They believed it enhanced patients' awareness of side effects and increased their feeling of involvement. The patients reported that it was easy to fill out the questionnaire and that it made sense to do so. However, a minority of the patients expressed in the interviews that they did not believe that the health care professionals had seen their reports when they came to the clinic, and that the reporting did not lead to increased contact with the department. CONCLUSIONS:Overall, satisfaction with the eHealth intervention was high among patients and their treating clinicians. The tool was easy to use and contributed to greater symptom awareness and patient involvement. Thus, in terms of patient and clinician satisfaction with the tool, it makes sense to continue using the tool beyond the project period. TRIAL REGISTRATION:ClinicalTrials.gov NCT03073031; https://tinyurl.com/tjx3gtu.

Dataset Information

Patient Reported Outcomes Have Arrived: A Practical Overview for Clinicians in Using Patient Reported Outcomes in Oncology.

Publications

Patient Reported Outcomes Have Arrived: A Practical Overview for Clinicians in Using Patient Reported Outcomes in Oncology.

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