Patient-reported Outcomes In Clinical Practice Research Articles

Recommendations to address respondent burden associated with patient-reported outcome assessment.

Patient-reported outcomes (PROs) are increasingly used in healthcare research to provide evidence of the benefits and risks of interventions from the patient perspective and to inform regulatory decisions and health policy. The use of PROs in clinical practice can facilitate symptom monitoring, tailor care to individual needs, aid clinical decision-making and inform value-based healthcare initiatives. Despite their benefits, there are concerns that the potential burden on respondents may reduce their willingness to complete PROs, with potential impact on the completeness and quality of the data for decision-making. We therefore conducted an initial literature review to generate a list of candidate recommendations aimed at reducing respondent burden. This was followed by a two-stage Delphi survey by an international multi-stakeholder group. A consensus meeting was held to finalize the recommendations. The final consensus statement includes 19 recommendations to address PRO respondent burden in healthcare research and clinical practice. If implemented, these recommendations may reduce PRO respondent burden.

Perceptions regarding the concept and definition of patient-reported outcomes among healthcare stakeholders in Japan with relation to quality of life: a cross-sectional study

Patient-reported outcomes (PROs) are frequently used in a variety of settings, including clinical trials and clinical practice. The definition of PRO and quality of life (QOL) and their relationship have been concluded through discussions among experts that has been the premise of PRO guidelines are not clearly stated in the guidelines. Therefore, the definition of PRO, especially in relation to QOL, is sometimes explained simply, as “PRO includes QOL,” but this complicated matters. This study investigated the perceptions of PRO among various stakeholders (including patients and their families, the industry, clinicians, regulatory or health technology assessment personnel, and academic researchers) in Japan to clarify its definitions and that of QOL, including their relationship.We conducted a two-step survey: a qualitative interview survey and a web-based survey to ensure the validity of the survey. During the interviews, eight stakeholders described their perceptions and thoughts on PRO and its relationship to QOL, and their experience of using PRO. Overall 253 clinicians, 249 company employees, and 494 patients participated in the web survey to confirm how the findings of the interview survey supported the results.In the interview survey, patient advocates described various perspectives of PRO and QOL, including unexpected dynamic relationships, while the most other stakeholders explained PRO and QOL with the language used in the guidelines, but their responses were split. The web-based survey revealed that all stakeholders had a lower awareness of PRO than QOL. The most common perception of PRO, especially in the relationship to QOL, was “they did not fully overlap.” Although there were differences in perceptions of the relationship between PRO and QOL among clinicians, company employees, and patients, all perceived PRO as a tool to facilitate communication in clinical practice.The present results are inconsistent with the simplified explanation of PRO, but consistent with the original PRO guideline definitions, which also considered the role of PRO in clinical practice. To make PRO a more potent tool, all stakeholders using PRO should confirm its definition and how it differs from QOL, have a unified recognition in each PRO use, and avoid miscommunication.

Electronic health record (EHR)-based PROMIS measures among neurology clinic decedents and survivors: a retrospective cohort analysis

BackgroundIn addition to their standard use to assess real-time symptom burden, patient-reported outcomes (PROs), such as the Patient-Reported Outcomes Measurement Information System (PROMIS), measures offer a potential opportunity to understand when patients are experiencing meaningful clinical decline. If PROs can be used to assess decline, such information can be used for informing medical decision making and determining patient-centered treatment pathways. We sought to use clinically implemented PROMIS measures to retrospectively characterize the final PROMIS report among all patients who completed at least one PROMIS assessment from December 2017-March 2020 in one large health system, stratified by decedents vs. survivors. We conducted a retrospective cohort analysis of decedents (N = 1,499) who received care from outpatient neurology clinical practice within a single, large health system as part of usual care. We also compared decedents to survivors (360 + days before death; N = 49,602) on PROMIS domains and PROMIS-Preference (PROPr) score, along with demographics and clinical characteristics. We used electronic health record (EHR) data with built-in PROMIS measures. Linear regressions assessed differences in PROMIS domains and aggregate PROPr score by days before death of the final PROMIS completion for each patient.ResultsAmong decedents in our sample, in multivariable regression, only fatigue (range 54.48–59.38, p < 0.0029) and physical function (range 33.22–38.38, p < 0.0001) demonstrated clinically meaningful differences across time before death. The overall PROPr score also demonstrated statistically significant difference comparing survivors (0.19) to PROPr scores obtained 0–29 days before death (0.29, p < 0.0001).ConclusionsAlthough clinic completion of PROMIS measures was near universal, very few patients had more than one instance of PROMIS measures reported, limiting longitudinal analyses. Therefore, patient-reported outcomes in clinical practice may not yet be robust enough for incorporation in prediction models and assessment of trajectories of decline, as evidenced in these specialty clinics in one health system. PROMIS measures can be used to effectively identify symptoms and needs in real time, and robust incorporation into EHRs can improve patient-level outcomes, but further work is needed for them to offer meaningful inputs for defining patient trajectories near the end of life.Plain English SummaryAssessing symptom burden provides an opportunity to understand clinical decline, particularly as people approach the end of life. We sought to understand whether symptoms reported by patients can be used to assess decline in health. Such information can inform decision-making about care and treatments. Of eight symptoms that we assessed, patient reports of fatigue and physical function were associated with clinical decline, as was an overall score of symptom burden. Because few symptoms were associated with decline, patient-reported outcomes in clinical practice may not yet be robust enough for incorporation in prediction models and assessment of trajectories of decline.

Hand therapist use of patient-reported outcomes

BackgroundThe use of standardized outcome measures is essential for best clinical practice by hand therapists to determine patient status, progress, and the outcome of interventions. A better understanding of current patient-reported outcome (PRO) use in hand and upper extremity practice is warranted. PurposeThis study sought to understand what outcome measures are being used in clinical practice, how they are being used, and the perceived usefulness of PROs by active members of the American Society of Hand Therapists (ASHT). Study DesignThis study employed a cross-sectional design. MethodsThe web-based survey was distributed through Qualtrics (Qualtrics, Salt Lake City, Utah) to active members of ASHT with an email address on file. The survey consisted of multiple choice and open-ended questions. ResultsA total of 348 members responded to the survey. Seven hundred thirty-two different outcome measures were reported to be used by the hand therapist respondents. The most used outcome measure was QuickDASH by 38% of the respondents. Two hundred seventy-five (88%) indicated that their workplace advocated the use of PROs. Most respondents indicated that there were not constraints preventing the use of a PRO. Few therapists respondents use a psychosocial PRO in clinical practice. ConclusionsMost of the hand therapist respondents to our survey use a PRO and discuss the results with their clients. The QuickDASH was the PRO used most often by hand therapists. Only a few hand therapists use a psychosocial tool to measure patient status in clinical practice.

The Real-World Global Use of Patient-Reported Outcomes for the Care of Patients With Inflammatory Bowel Disease.

Many patient-reported outcomes (PROs) have been developed for inflammatory bowel disease (IBD) without recommendations for clinical use. PROs differ from physician-reported disease activity indices; they assess patients' perceptions of their symptoms, functional status, mental health, and quality of life, among other areas. We sought to investigate the current global use and barriers to using PROs in clinical practice for IBD. A cross-sectional survey was performed. An electronic questionnaire was sent to an international group of providers who care for patients with IBD. There were 194 respondents, including adult/pediatric gastroenterologists, advanced practice providers, and colorectal surgeons from 5 continents. The majority (80%) use PROs in clinical practice, 65% frequently found value in routine use, and 50% frequently found PROs influenced management. Thirty-one different PROs for IBD were reportedly used. Barriers included not being familiar with PROs, not knowing how to incorporate PRO results into clinical practice, lack of electronic medical record integration, and time constraints. Most (91%) agreed it would be beneficial to have an accepted set of consistently used PROs. The majority (60%) thought that there should be some cultural differences in PROs used globally but that PROs for IBD should be consistent around the world. PROs are used frequently in clinical practice with wide variation in which are used and how they influence management. Education about PROs and how to use and interpret an accepted set of PROs would decrease barriers for use and allow for global harmonization.

Engaging Continuing Medical Education Reveals Persisting Knowledge and Practice Gaps in FLT3-Positve AML

Introduction: Given the rapid evolution of testing and treatment of FMS-like tyrosine kinase 3 (FLT3)-positive AML, oncology providers are challenged by how to administer the latest evidence-based care. Additionally, while the use of patient-reported outcomes (PROs) can improve patient care, they are underutilized in oncology practice An interactive continuing medical education (CME) activity was provided to assess baseline attitudes and practice patterns while also addressing identified gaps in knowledge and skills regarding the management of patients with FLT3-positive AML. Methods: Vindico Medical Education provided a web-based CME activity available on myCME.com and for credit from December 31, 2021 to December 30, 2022. The activity included opportunities for interaction with the content to encourage engagement, transfer knowledge, improve confidence, and assess current practice patterns. Impact of education was measured by comparing paired pre- and post-test responses. Results: As of July 2022, 216 hematology/oncology providers who each see an average of 8 patients with AML per month participated in the education. These providers scored an average 26% on a pretest for topics related to the evaluation of patients with AML the impact of FLT3 mutations on prognosis and management, and the use of PROs in practice. Post-learning, providers scored 49%, highlighting the impact of the education on knowledge gaps, but also demonstrating persisting gaps. Specifically, post-test scores remained lowest regarding the implications of FLT3 mutations on patient outcomes and treatment strategies for these patients. Notably, while 65% of these providers indicated that they were guessing on the pre-test, the percentage of those who were confident and correct on the post-test rose from 1% to 18%, demonstrating a sharp rise in confidence. However, these persisting knowledge and confidence gaps translated to practice gaps - only 40% currently report performing mutational analysis at relapse for patients with AML. Moreover, only 51% were familiar with FLT3 MRD testing and providers lacked consensus regarding first- and subsequent-line treatment for FLT3-positive patients. Forty-seven percent noted an uncertainty regarding optimal combinations and sequencing as the primary challenge they face when selecting treatment for these patients. While knowledge and confidence scores regarding the use of PROs were high, only 16% always use PROs in practice, with patient non-compliance as the biggest barrier to implementation. Conclusion: Hematology/oncology providers lack knowledge and confidence regarding testing and management of patients with FLT3-positive AML, which translates to practice gaps. While the use of interactive CME led to robust gains in knowledge and confidence, further education is needed to address persisting gaps regarding testing and management of patients with FLT3-positive AML. Moreover, skills-based training and patient resources are needed to facilitate the use of PROs in clinical practice.

The feasibility and value of assessing patient-reported outcomes in pulmonary arterial hypertension.

Pulmonary arterial hypertension (PAH) is a progressive pulmonary vascular disease that negatively impacts health‐related quality of life (HRQOL). The PAH‐symptoms and impact (PAH‐SYMPACT) questionnaire is a validated disease‐specific patient‐reported outcome (PRO) instrument that assesses a patient's symptoms and the impact of PAH and its treatment on well‐being. We performed a single‐center prospective cohort study of patients with PAH to determine the feasibility of assessing PROs in clinical practice and to determine the association between PAH‐SYMPACT domains and clinical characteristics and outcomes. One hundred and ten patients completed the 1‐day version of the PAH‐SYMPACT questionnaire which consists of 22 Likert‐scale questions that assess HRQOL across four domains: cardiopulmonary (CP) symptoms, cardiovascular (CV) symptoms, physical impact (PI), and cognitive and emotional (CE) impact. Higher scores indicate worse HRQOL. Patients were predominantly female (n = 86, 78%) with a mean age of 57.8 ± 16.2 years. While several patient characteristics were associated with CP and PI domains, few were associated with CV and CE domains. PI and CE impact scores were associated with recent hospitalizations and mortality and CE impact score was independently associated with an increased risk of death after adjustment for disease severity (hazard ratio: 3.29, 95% confidence interval: 1.56–6.91, p = 0.002). In conclusion, the assessment of PROs in clinical practice using the PAH‐SYMPACT questionnaire is both feasible and valuable. PAH‐SYMPACT scores have independent prognostic value and are not adequately reflected by traditional measures of disease severity. These findings underscore the importance of assessing HRQOL in clinical practice.

Recruiting Adolescent and Young Adult Cancer Survivors for Patient-Reported Outcome Research: Experiences and Sample Characteristics of the SURVAYA Study.

Background: Participation of Adolescents and Young Adults with cancer (AYAs: 18–39 years at time of diagnosis) in patient-reported outcome studies is warranted given the limited knowledge of (long-term) physical and psychosocial health outcomes. We examined the representativeness of AYAs participating in the study, to observe the impact of various invitation methods on response rates and reasons for non-participation. Methods: A population-based, cross-sectional cohort study was performed among long-term (5–20 years) AYA cancer survivors. All participants were invited using various methods to fill in a questionnaire on their health outcomes, including enclosing a paper version of the questionnaire, and sending a reminder. Those who did not respond received a postcard in which they were asked to provide a reason for non-participation. Results: In total, 4.010 AYAs (response 36%) participated. Females, AYAs with a higher socio-economic status (SES), diagnosed more than 10 years ago, diagnosed with a central nervous system tumor, sarcoma, a lymphoid malignancy, stage III, or treated with systemic chemotherapy were more likely to participate. Including a paper questionnaire increased the response rate by 5% and sending a reminder by 13%. AYAs who did not participate were either not interested (47%) or did want to be reminded of their cancer (31%). Conclusions: Study participation was significantly lower among specific subgroups of AYA cancer survivors. Higher response rates were achieved when a paper questionnaire was included, and reminders were sent. To increase representativeness of future AYA study samples, recruitment strategies could focus on integrating patient-reported outcomes in clinical practice and involving AYA patients to promote participation in research.

Defining a Standard Set of Patient-Reported Outcomes for Patients With Advanced Ovarian Cancer.

PurposeAdvanced ovarian cancer (AOC) and its treatment cause several symptoms and impact on patients’ health-related quality of life (HRQoL). We aim to reach a consensus on the most relevant patient-reported outcome (PROs), the corresponding measures (PROMs), and measurement frequency during AOC patients’ follow-up from patients’ and healthcare professionals’ (HCP) perspective.MethodsThe project comprised five steps: 1) a literature review, 2) a focus group with patients, 3) a nominal group with HCP, 4) two round-Delphi consultations with patients and HCP, and 5) a final meeting with HCP. Delphi questionnaire was elaborated based on literature review, focus group (n=5 patients), and nominal group (n=16 HCP). The relevance of each PRO and the appropriateness (A) and feasibility (F) of the proposed PROM were assessed (Likert scale 1=strongly agree; 9=strongly disagree). The consensus was reached when at least 75% of the panelists rated it as ‘relevant’, ‘appropriate’, or ‘feasible’ (score 7-9).ResultsA total of 56 HCP [51.8% Hospital Pharmacy; 41.1% Oncology; 3.6% Nursing; and 3.6% Psycho-oncology; mean time in specialty 12.5 (8.0) years] and 10 AOC patients [mean time diagnosis 5.4 (3.0) years] participated in the 1st round. All PROs achieved consensus regarding their relevance, except dry skin (58.0%). Agreement was reached for PRO-CTCAE to be used to assess fatigue (A:84.9%; F:75.8%), neuropathy (A:92.4%; F:77.3%), diarrhea (A:87.9%; F:88.7%), constipation (A:86.4%; F:75.8%), nausea (A:89.4%; F:75.8%), insomnia (A:81.8%; F:88.7%), abdominal bloating (A:82.2%; F:82.2%) and sexuality (A:78.8%; F:88.6%); EQ-5D to determine patients’ HRQoL (A:87.9%; F:80.3%), pain (A:87.9%; F:75.8%) and mood (A:77.7%; F:85.5%); to assess treatment adherence the Morisky-Green (A:90.9%; F:84.9%) and the dispensing register (A:80.3%; F:80.3%) were chosen. It was agreed to note in the medical record whether the patient’s treatment preferences had been considered during decision-making (A:78.8%; F:78.8%) and to use a 5-point Likert scale to assess treatment satisfaction (A:86.4%; F:86.4%). Panelists agreed (A:92.4%; F: 77.3%) to collect these PROs (1) at the time of diagnosis/relapse; (2) one month after starting treatment/change therapeutic strategy; (3) every three months during the 1st-year of treatment; and later (4) every six months until treatment completion/change.ConclusionsThe consensus reached represents the first step towards including the patient’s perspective in AOC follow-up. The standardized collection of PROs in clinical practice may contribute to optimizing the follow-up of these patients and thus improving the quality of care.

Oncoplastic breast consortium recommendations for mastectomy and whole breast reconstruction in the setting of post-mastectomy radiation therapy

AimDemand for nipple- and skin- sparing mastectomy (NSM/SSM) with immediate breast reconstruction (BR) has increased at the same time as indications for post-mastectomy radiation therapy (PMRT) have broadened. The aim of the Oncoplastic Breast Consortium initiative was to address relevant questions arising with this clinically challenging scenario. MethodsA large global panel of oncologic, oncoplastic and reconstructive breast surgeons, patient advocates and radiation oncologists developed recommendations for clinical practice in an iterative process based on the principles of Delphi methodology. ResultsThe panel agreed that surgical technique for NSM/SSM should not be formally modified when PMRT is planned with preference for autologous over implant-based BR due to lower risk of long-term complications and support for immediate and delayed-immediate reconstructive approaches. Nevertheless, it was strongly believed that PMRT is not an absolute contraindication for implant-based or other types of BR, but no specific recommendations regarding implant positioning, use of mesh or timing were made due to absence of high-quality evidence. The panel endorsed use of patient-reported outcomes in clinical practice. It was acknowledged that the shape and size of reconstructed breasts can hinder radiotherapy planning and attention to details of PMRT techniques is important in determining aesthetic outcomes after immediate BR. ConclusionsThe panel endorsed the need for prospective, ideally randomised phase III studies and for surgical and radiation oncology teams to work together for determination of optimal sequencing and techniques for PMRT for each patient in the context of BR

State of the Art of Patient-reported Outcomes in Acromegaly or GH Deficiency: A Systematic Review and Meta-analysis.

ContextInsight into the current landscape of patient-reported outcome (PRO) measures (PROM) and differences between PROs and conventional biochemical outcomes is pivotal for future implementation of PROs in research and clinical practice. Therefore, in studies among patients with acromegaly and growth hormone deficiency (GHD), we evaluated (1) used PROMs, (2) their validity, (3) quality of PRO reporting, (4) agreement between PROs and biochemical outcomes, and (5) determinants of discrepancies.Evidence AcquisitionWe searched 8 electronic databases for prospective studies describing both PROs and biochemical outcomes in acromegaly and GHD patients. Quality of PRO reporting was assessed using the International Society for Quality of Life Research (ISOQOL) criteria. Logistic regression analysis was used to evaluate determinants.Evidence SynthesisNinety studies were included (acromegaly: n = 53; GHD: n = 37). Besides nonvalidated symptom lists (used in 37% of studies), 36 formal PROMs were used [predominantly Acromegaly Quality of Life Questionnaire in acromegaly (43%) and Quality of Life-Assessment of Growth Hormone Deficiency in Adults in GHD (43%)]. Reporting of PROs was poor, with a median of 37% to 47% of ISOQOL items being reported per study. Eighteen (34%) acromegaly studies and 12 (32%) GHD studies reported discrepancies between PROs and biochemical outcomes, most often improvement in biochemical outcomes without change in PROs.ConclusionsProspective studies among patients with acromegaly and GHD use a multitude of PROMs, often poorly reported. Since a substantial proportion of studies report discrepancies between PROs and biochemical outcomes, PROMs are pivotal in the evaluation of disease activity. Therefore, harmonization of PROs in clinical practice and research by development of core outcome sets is an important unmet need.

Difference in Estimation of Side Effects of Chemotherapy between Physicians and Patients with Early-Stage Breast Cancer: The Use of Patient Reported Outcomes (PROs) in the Evaluation of Toxicity in Everyday Clinical Practice.

Simple SummaryPatient reported outcomes (PROs) are frequently integrated into routine toxicity monitoring in clinical studies but not so often in everyday clinical practice. Our investigation, conducted on patients with early stage breast cancer, showed disproportion between patient and physician perceptions of side effects by using a PRO questionnaire for patients and then the questionnaire with the same questions for physicians estimation. We found this result to be very important because the use of PRO in our clinical practice helped us determine the group of patients which required additional care to help them tolerate treatment-related side effects, have better quality of life during treatment and ultimately have best possible outcome.Knowledge about the patient’s experience and perception of side effects and their impact on daily life is crucial for the adequate planning of interventions to provide the highest attainable levels of quality of life during oncology treatment. We conducted a study on consecutive samples of 69 early breast cancer patients treated with four cycles of neoadjuvant or adjuvant anthracycline-based chemotherapy. Patients completed the questionnaire about side effects experienced after the previous cycle of chemotherapy. The questionnaire was a modified PRO for the evaluation of treatment toxicity consisting of 18 questions related to the very common and common side effects of doxorubicin and cyclophosphamide, valued from 0 to 3 according to the subjective assessment of the patient. During the same cycles of therapy, data were also collected by the physician who completed a questionnaire consisting of the same questions as the questionnaire for patients, on the same scale. Most of the side effects reported by patients were mild to moderate in intensity, while physicians reported side effects much less frequently. The results also indicated a disproportionate reporting, in which physicians reported statistically significantly fewer side effects than patients. This study reported a level of disagreement between patients and physicians in the experience of therapy toxicity. In conclusion, use of PRO in clinical practice can help us avoid physician subjectiveness in the estimation of side effects and determine the group of patients who can benefit from additional and individualized supportive care measures, which could lead to better adherence to therapy and ultimately best outcomes.

Comparative Effectiveness of Dosing of Medical Therapy for Heart Failure: From the CHAMP-HF Registry

The comparative effectiveness of differing dosages of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) on clinical and patient-reported outcomes in clinical practice in the United States is unknown. This study sought to characterize associations between the dosing of GDMT and outcomes for patients with HFrEF in U.S. clinical practice. This analysis included 4832 outpatients who had chronic HFrEF across 150 practices in the U.S. in the Change the Management of Patients with Heart Failure (CHAMP-HF) registry with no contraindication and available dosing data for at least 1 GDMT at baseline. Baseline dosing of angiotensin-converting enzyme (ACEI)/angiotensin II receptor blocker (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), beta-blocker, and mineralocorticoid receptor antagonist (MRA) therapies were examined. For each medication class, multivariable models assessed associations between medication dosing and clinical outcomes over 24 months (all-cause mortality, HF hospitalization) and patient-reported outcomes at 12 months (change in the Kansas City Cardiomyopathy Questionnaire Overall Summary score [KCCQ-OS]). After adjustment, compared with target dosing, lower dosing was associated with higher all-cause mortality for ACEIs/ARBs/ARNIs (50% to < 100% target dosage, HR 1.16 [95% CI 0.87-1.55]; < 50% target dosage, HR 1.37 [95% CI 1.05-1.79]; none, HR 1.75 [95% CI 1.32-2.34; overall P< 0.001) and beta-blockers (50% to < 100% target dosage, HR 1.30 [95% CI 1.00-1.69]; < 50% target dosage, HR 1.41 [95% CI 1.11-1.79; none, HR 1.24 [95% CI 0.92-1.67]; overall P= 0.042). Lower dosing of ACEIs/ARBs/ARNIs was independently associated with higher risk of HF hospitalization (50% to < 100% target dosage, HR 1.08 [95% CI 0.90-1.30]; < 50% target dosage, HR 1.23 [1.04-1.47]; none, HR 1.29 [1.04-1.60]; overall P= 0.046), but beta-blocker dosing was not (overall P= 0.085). Target dosing of MRAs was not associated with risk of mortality or HF hospitalization. For each GDMT, compared with target dosing, lower dosing was not associated with change in the KCCQ-OS at 12 months, with the potential exception of worsening KCCQ-OS scores with lower dosing of ACEIs/ARBs/ARNIs. In this contemporary U.S. outpatient HFrEF registry, target dosing of ACEI/ARB/ARNI and beta-blocker therapy was associated with reduced mortality and was variably associated with HF hospitalization and patient-reported outcomes. MRA dosing was not associated with outcomes. The totality of these findings support the benefits of target dosing of GDMT in routine practice, as tolerated, with unmeasured differences among patients receiving differing dosages potentially explaining the differing results seen here compared with randomized clinical trials.

Adoption of patient-reported outcomes (PROs) in clinical practice for older patients receiving active anticancer treatment: Impact on health-related quality of life (QoL).

e24014 Background: PROs are the gold standard to describe subjective symptoms. In order to improve clinical management of outpatients receiving active anti-cancer treatment at Medical Oncology, Mauriziano Hospital, Turin, Italy, in January 2018 we introduced in routine clinical practice an assessment of patient-reported symptoms and toxicities. We demonstrated that use of PROs in clinical practice was associated with a significant QoL improvement, compared to the traditional visit (Baratelli, Support Care Cancer 2019). In this secondary analysis, we show the results obtained in older pts ( &gt; 70yrs). Methods: Eligible pts were receiving an active anti-cancer treatment, as outpatients. Pts treated in 2017 underwent “usual” visits (group A), while pts treated in 2018 before each visit received a paper questionnaire by a dedicated nurse, in order to provide information about symptoms and toxicities to be discussed during visit (group B). Primary objective was the comparison of QoL changes, measured by EORTC QLQ-C30. Results: Out of 211 pts, 88 were older than 70 yrs (47 group A, 41 group B). Median age was 76 (70-84 yrs). Most common tumors were colorectal (25.0%), lung (22.7%) and pancreatic (17.0%). 68.2% were receiving first-line treatment. Tumors and setting were similar between group A and B. Younger and older pts had comparable baseline QoL scores: mean global QoL score was 59.96 in younger pts vs. 57.39 in older pts. After 1 month, global QoL of older pts was significantly improved in group B compared to group A: mean change from baseline was -0.89 group A vs. +4.47 group B (p = 0.006, effect size 0.23). There were statistically significant differences in mean changes from baseline, in favor of group B, for role functioning (-5.67 group A and -0.81 group B, p = 0.034, effect size 0.20) and emotional functioning (-2.30 group A and +3.25 group B, p = 0.014, effect size 0.36). Mean changes from baseline for pain were significantly better for group B (-3.25) than group A (+6.03, p = 0.01, effect size 0.43). There were no significant differences between the 2 groups in terms of other functional scales or symptoms. There was no significant heterogeneity in the proportion of QoL responders between younger and older pts (p = 0.60). The proportion of older pts obtaining a clinically significant improvement in global QoL was numerically higher in group B (36.6%) compared to group A (19.1%, p = 0.09). Odds Ratio of obtaining an improvement in global QoL for group B vs group A was 1.73 (95%CI 0.75 – 3.99) in younger pts and 2.44 (95%CI 0.93 – 6.40) in older pts. Conclusions: This secondary analysis shows that the use of PROs in clinical practice, thanks to an active role of nurses and discussion of symptoms with physicians during the visit, is associated, also in older patients receiving active anticancer treatment, with a significant improvement in global QoL.

Primary care physician’s (PCP) perceived value of patient-reported outcomes (PROs) in clinical practice: a mixed methods study

BackgroundPatient-reported outcomes (PROs) can promote patient engagement, shared-decision making and improve the overall experience of care. However, PRO integration in the primary care clinical setting is limited. Exploring the perspectives...

Using patient-reported outcomes in measurement-based care: perceived barriers and benefits in oncologists and mental health providers

Patient-reported outcomes (PRO) are assessments of a patient’s perception of their own health. PROs are often used in measurement-based care (MBC) to assess whether a treatment is working or needs to be changed. We compared oncology providers to mental health providers about barriers and benefits for PRO-based MBC. Oncologists (n = 200) and mental health professionals (n = 250) were recruited through a survey panel. The survey was designed with input from providers and a patient investigator. Multivariate analyses compared oncologists to mental health professionals and never users of PROs to current PRO users. The most frequent barriers out of 13 were patients not wanting to complete PROs (55%), time (44%), training (37%), not knowing about PROs (33%), and PROs not accounting for individual differences (26%). Oncologists were more likely to report not being trained, not having the technology or funding to administer PROs to patients, not knowing how to interpret PROs, and not having PROs that meet their clinical needs (p < .05) than mental health professionals. Oncologists were also less likely to say that PROs helped justify continued treatment (p = .01) and were more likely to report that PROs helped patients get better faster and that PROs improved communication (p < .05) than mental health professionals. Oncology providers reported less familiarity with PROs and fewer resources to administer PROs in clinical practice. While logistical barriers likely impede PRO use in MBC, identifying specialty specific barriers and allowing PROs to be individualized to the patient may also improve PRO use for all providers.

The Smartphone App haMSter for Tracking Patient-Reported Outcomes in People With Multiple Sclerosis: Protocol for a Pilot Study.

BackgroundTreatment and monitoring decisions in people with multiple sclerosis (MS) are based commonly on clinician-reported outcomes. These reflect physical and radiological disease activity and are the most relevant endpoints in clinical trials. Over the past few years, the number of studies evaluating so-called patient-reported outcomes (PROs) has been increasing. PROs are reports from patients concerning their own health perception. They are typically obtained by means of questionnaires and aim to quantify symptoms such as fatigue, depression, and sexual dysfunction. The emergence of PROs has made a tremendous contribution to understanding the individual impact of disease in people with MS and their health-related quality of life. However, the assessment of PROs consumes resources, including time and personnel. Thus, useful ways to conveniently introduce PROs into clinical practice are needed.ObjectiveWe aim to provide a rationale and pilot study protocol for a mobile health (mHealth) solution named “haMSter” that allows for remote monitoring of PROs in people with MS.MethodsThe core function of haMSter is to provide three scientifically validated PRO questionnaires relevant to MS for patients to fill out at home once a month. Thereby, longitudinal and remote documentation of PROs is enabled. A scoring algorithm graphically plots PRO scores over time and makes them available at the next visit.ResultsThe pilot study is currently ongoing and will evaluate adherence to this mHealth solution in 50 patients over a period of 6 months. Results from the haMSter pilot study are expected in 2021.ConclusionshaMSter is a novel mHealth-based solution for modern PRO research, which may constitute the first step in achieving the ability to integrate PROs in clinical practice. This allows for a more problem-oriented approach in monitoring visits, which addresses patient needs and ultimately saves time.Trial RegistrationClinicalTrials.gov NCT04555863; https://clinicaltrials.gov/ct2/show/NCT04555863International Registered Report Identifier (IRRID)DERR1-10.2196/25011

Glioma patient-reported outcomes: patients and clinicians

IntroductionRoutine assessment of patient-reported outcomes (PROs) in oncology has shown to improve the quality of the delivered care and to prolong survival. However, for successful implementation of routine assessment of...

Measuring quality of life in older people with cancer.

The number of individuals aged 65+ with cancer will double in the next decade. Attention to quality of life (QOL) is imperative to identify relevant endpoints/outcomes in research and provide care that matches individual needs. This review summarizes recent publications regarding QOL measurement in older adults with cancer, considering implications for research and practice. QOL is a complex concept and its measurement can be challenging. A variety of measurement tools exist, but only one specific to older adults with cancer. QOL is frequently measured as functional health, adverse symptoms, and global QOL, thus only capturing a portion of this concept. Yet successful QOL intervention for older adults requires drawing from behavioral and social dimensions.Growing interest in comprehensive geriatric assessment (CGA) and patient-reported outcomes (PROs) provides important opportunities for measuring QOL. Recommendations for use of CGAs and PROs in clinical practice have been made but widespread uptake has not occurred. QOL is important to older adults and must be central in planning and discussing their care. It is modifiable but presents measurement challenges in this population. Various domains are associated with decline, survival, satisfaction with life, coping, and different interventions. Measurement approaches must fit with intention and capacity to act within given contexts.

Impact of adoption of patient-reported outcomes in clinical practice on the accuracy of symptom reporting in medical records of cancer patients.

Medical records are a relevant source for real-world evidence. We introduced patient-reported outcomes (PROs) in clinical practice, demonstrating a significant quality-of-life improvement, compared to usual visit. In this secondary analysis, we describe the agreement between patients' and physicians' reports of 5 symptoms. Our hypothesis was that adoption of PROs questionnaire could significantly improve the agreement. Eligible patients were receiving active anti-cancer treatment. Patients in the control group underwent usual visits (group A), while patients of group B, before each visit, filled a PROs paper questionnaire, to provide information about symptoms and toxicities. No specific instructions were provided to physicians to integrate such information in medical records. Agreement between patient and physician evaluations was assessed by Cohen's κ, calculating under-reporting as proportion of toxicities reported by patients but not recorded by physicians. 211 patients (412 visits) have been analyzed. For all symptoms, Cohen's κ was better for group B: emesis (0.25 group A vs. 0.36 group B), diarrhea (0.16 vs. 0.57), constipation (0.07 vs. 0.28), pain (0.22 vs. 0.42), fatigue (0.03 vs. 0.08). For all symptoms, although under-reporting was relevant in both groups, it was lower for group B: emesis (75.49% vs. 60.0%, p=0.031), diarrhea (82.89% vs. 50.0%, p<0.001), constipation (92.11% vs. 69.57%, p<0.001), pain (59.57% vs. 42.31%, p=0.01), fatigue (82.11% vs. 64.10%, p<0.001). Adoption of paper PROs allowed a significant reduction in under-reporting of symptoms, but agreement remained suboptimal. Direct integration of electronic PROs could minimize the issue of under-reporting of medical records, increasing their accuracy.