What Really Matters Is Rarely Measured: Outcome of Routine Care and Patient-reported Outcomes

2013 ◽  
Vol 64 (1) ◽  
pp. 58-59 ◽  
Author(s):  
Manfred P. Wirth ◽  
Johannes Huber
EP Europace ◽  
2019 ◽  
Vol 22 (3) ◽  
pp. 368-374 ◽  
Author(s):  
Benjamin A Steinberg ◽  
Jeffrey Turner ◽  
Ann Lyons ◽  
Joshua Biber ◽  
Mihail G Chelu ◽  
...  

Abstract Aims Incorporating patient-reported outcomes (PROs) into routine care of atrial fibrillation (AF) enables direct integration of symptoms, function, and health-related quality of life (HRQoL) into practice. We report our initial experience with a system-wide PRO initiative among AF patients. Methods and results All patients with AF in our practice undergo PRO assessment with the Toronto AF Severity Scale (AFSS), and generic PROs, prior to electrophysiology clinic visits. We describe the implementation, feasibility, and results of clinic-based, electronic AF PRO collection, and compare AF-specific and generic HRQoL assessments. From October 2016 to February 2019, 1586 unique AF patients initiated 2379 PRO assessments, 2145 of which had all PRO measures completed (90%). The median completion time for all PRO measures per visit was 7.3 min (1st, 3rd quartiles: 6, 10). Overall, 38% of patients were female (n = 589), mean age was 68 (SD 12) years, and mean CHA2DS2-VASc score was 3.8 (SD 2.0). The mean AFSS symptom score was 8.6 (SD 6.6, 1st, 3rd quartiles: 3, 13), and the full range of values was observed (0, 35). Generic PROs of physical function, general health, and depression were impacted at the most severe quartiles of AF symptom score (P < 0.0001 for each vs. AFSS quartile). Conclusion Routine clinic-based, PRO collection for AF is feasible in clinical practice and patient time investment was acceptable. Disease-specific AF PROs add value to generic HRQoL instruments. Further research into the relationship between PROs, heart rhythm, and AF burden, as well as PRO-guided management, is necessary to optimize PRO utilization.


2018 ◽  
Vol 36 (7_suppl) ◽  
pp. 7-7
Author(s):  
Timo Schinkothe ◽  
Susan Praveen ◽  
Abhishek Lal ◽  
Baiju Rahman

7 Background: It is proven that the online documentation and transmission of symptoms can prolong the overall survival of cancer patients. Recent studies have shown that this advantage exists both in conventional chemotherapy and in oral therapy.Current implementations require a healthcare professional who monitors the data online. In most centers, such kind of human resources is not available except in clinical trials. It was therefore the goal of this project to develop an eHealth procedure, in which no permanent online observation is necessary. Methods: PRO-React, a symptom-based automated feedback or advice feature is integrated into the eHealth platform CANKADO. In the online settings, physician activates medication plans for his patients, documents drug-taking and sets reminders for the patient of future intake times. PRO-React assists the patients daily in global health documentation and dynamic symptom questionnaires. A built-in automated analysis brings forth suitable recommendations for patients like discuss with the physician, visit the physician immediately, visit directly or go to ER. The patient reported outcomes are shared in real-time with the physicians. Results: Trials are ongoing. Interim analysis is planed for January 2018. Results will be presented at the conference. Conclusions: PRO-React helps in the dynamic recognition of events with minimal daily documentation from the patients as well as assist in reacting to the needs of the patients. It also circumvents the need of a mediator group like nurses and thereby increase compliance and improve the doctor-patient-relationship leading to decreased mortality and higher patient satisfaction. PRO-React is available for routine care but also included into several multi-center trials.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7044-7044
Author(s):  
Ethan M. Basch ◽  
Randall Teal ◽  
Amylou C. Dueck ◽  
Jennifer Jansen ◽  
Sydney Henson ◽  
...  

7044 Background: There is growing interest to implement electronic patient-reported outcomes in oncology practices for symptom monitoring. It is not well known what nurse, physician, and patient impressions of benefits, acceptability, and challenges are in routine care use. Methods: PRO-TECT is an ongoing U.S. national trial including 26 community oncology practices across 15 states that implemented PRO symptom monitoring [NCT03249090]. Patients complete weekly PROs between visits, nurses receive alerts for severe/worsening symptoms, and oncologists review PROs at office visits. Interviews were conducted with 147 stakeholders including nurses (N = 46), oncologists (N = 27), data managers (N = 15), and patients (N = 59). Each stakeholder group had different interview guides with overlapping topics to explore experiences with the PRO system. Interviews lasted 15-60 minutes, were digitally recorded, transcribed, and entered into a qualitative analysis software program. A codebook was developed from the research questions, interview guides, and discussions with the project team. Standardized coding methods were applied, with transcripts double coded for thematic analysis. Feedback surveys were also completed by nurses (N = 57), oncologists (N = 38), and patients (N = 435). Results: Key benefits perceived across stakeholder groups included increased patient self-awareness of symptoms; improved direct communication of patients with care teams; more open and honest conveying of symptom experiences; ability to track symptoms over time; and increased involvement of patients in their own care. Most stakeholders felt PRO symptom monitoring had a positive impact on quality of care delivery, and believed benefits of PROs outweighed necessary staff efforts. Challenges included additional work by nurses to review and respond to alerts, staff turnover requiring retraining, and limited time of oncologists. In the survey, 39/56 (70%) nurses felt the PRO system improved quality of care; 27/33 (82%) oncologists noted PROs were useful for team discussions and care delivery; and 320/434 (74%) patients agreed that weekly PRO reporting improved discussions with their care team. Conclusions: Clinicians and patients perceived weekly PRO symptom monitoring between visits to be valuable despite added staff effort. Results of additional analyses are forthcoming. Clinical trial information: NCT03249090 .


2013 ◽  
Vol 64 (1) ◽  
pp. 60-61
Author(s):  
Khurshid A. Guru ◽  
James O. Peabody ◽  
Kamran Ahmed ◽  
Adam Kibel ◽  
Alon Weizer ◽  
...  

2011 ◽  
Vol 54 (1) ◽  
pp. 141-147 ◽  
Author(s):  
M. S. Kozak ◽  
M. J. Mugavero ◽  
J. Ye ◽  
I. Aban ◽  
S. T. Lawrence ◽  
...  

2017 ◽  
pp. 1-10 ◽  
Author(s):  
Nicholas G. Wysham ◽  
Steven P. Wolf ◽  
Gregory Samsa ◽  
Amy P. Abernethy ◽  
Thomas W. LeBlanc

Purpose Routinely collected patient-reported outcomes (PROs) could provide invaluable data to a patient-centered learning health system but are often highly missing in clinical trials. We analyzed our experience with PROs to understand patterns of missing data using electronic collection as part of routine clinical care. Methods This is an analysis of a prospectively collected observational database of electronic PROs captured as part of routine clinical care in four different outpatient oncology clinics at an academic referral center. Results More than 24,000 clinical encounters from 7,655 unique patients are included. Data were collected via an electronic tablet–based survey instrument (Patient Care Monitor, version 2.0), at the time of clinical care, as part of routine care processes. Missing instruments (ie, no items completed) were submitted for 6.8% of clinical encounters, and 15.8% of encounters had missing items. Nearly 90% of all encounters involved < 10% missing items. In multivariable analyses, younger age, private health insurance, being seen in the breast oncology clinic, less time spent on the instrument, and longitudinal care were significantly associated with less missingness. Conclusion Embedding collection of electronic PRO data into routine clinical care yielded low rates of missing data in this real-world, prospectively collected database. In contrast to clinical trial experience, missingness improve with longitudinal care. This approach may be a solution to minimizing missingness of PROs in research or clinical care settings in support of learning health care systems.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 177-177
Author(s):  
Shruti Sinkar ◽  
Faith Too ◽  
Kelly Carr ◽  
Jessica Jelinek ◽  
Elizabeth Saylor ◽  
...  

177 Background: Use of patient-reported outcomes (PRO) to evaluate symptoms improves clinical outcomes. Best practices for implementing PROs into routine care may vary according to clinical scenario, site-specific resources and programmatic goals. Patients with metastatic breast cancer (MBC) often experience a variety of symptoms. Methods: As a quality improvement project, we are pilot testing incorporation of a battery of PRO measures into routine care for patients with MBC at Johns Hopkins in order to gain experience that will guide future broader implementation of PROs across our program. Participants complete the PROs on paper at baseline (BL), 3, and 6 months (mo). Measures include NCCN Distress Thermometer (BL only), Patient Health Questionnaire-8 (PHQ-8), Generalized Anxiety Disorder-7 (GAD-7), PRO-CTCAE Insomnia questions and a modified version of the revised Edmonton Symptom Assessment System (r-ESAS) questionnaire with 3 extra symptom domains. Project team members alert clinicians by email of scores that exceed severity thresholds as follows – Distress: ≥4, PHQ-8: ≥8, GAD-7: ≥10, any item on r-ESAS: ≥4 and PRO-CTCAE Insomnia: severe/very severe or quite a bit/very much. Results: From May 29, 2020 and April 5, 2021, 67 patients were approached for participation, and 40 (59.7%) completed the BL PROs. Median age was 64 (range 36-85). Most participants were White (70%), non-Hispanic (90%) and had hormone receptor-positive (93%) MBC. At BL, 22 (55%) had visceral disease and most were receiving endocrine-based regimens [21 (53%)] or chemotherapy [16 (40%)]. 27 (68%) participants had ≥1 BL alert. The most common BL alerts were for symptoms on the r-ESAS [23 participants (58%)]. The most frequent items on the r-ESAS for which participants had BL alerts were pain, tiredness, well-being, tingling/numbness and rash. Other BL alerts were: Distress [9 participants (23%)], PRO-CTCAE Insomnia [5 participants (13%)], PHQ-8 [4 participants (10%)] and GAD-7 [2 participants (5%)]. To date, 24 of 35 (69%) and 15 of 28 (54%) participants who have reached the 3 and 6 mo time points have completed the respective follow-up (FU) PROs. Most common FU alerts to date are on the r-ESAS [3 mo: 14 participants (58%), 6 mo: 9 participants (60%)]. The project team has successfully notified providers of all alerts to date. Clinical actions (phone calls, provider visits and/or referrals) have been taken within 30 days of notification for > 75% of alerts. Conclusions: Implementation of a PRO battery for patients receiving routine care for MBC led to detection of a range of symptoms, the majority of which were clinically actionable. Restrictions on in-person interactions during the COVID-19 pandemic may have contributed to low rates of PRO completion in this pilot project. Prior to broader implementation, we will consider strategies such as an electronic platform and a shorter battery to enhance patient engagement.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 789.2-790
Author(s):  
A. Abdalla ◽  
A. Rambojun ◽  
L. C. Coates ◽  
E. Korendowych ◽  
N. Mchugh ◽  
...  

Background:Biologic interventions using highly specific immuno-modulatory biologic disease-modifying anti-rheumatic drugs (bDMARDs) represent a rapidly developing therapeutic approach to the treatment of Psoriatic Arthritis (PsA). However, despite high rates of response, adverse events, primary and secondary inefficacy are common, and multiple sequential lines of bDMARDs are often required. Data on drug persistence, as a surrogate for response, from national registries indicates switching has become accepted routine practice. One third of patients will fail or discontinue their first biologic with a significant proportion switching on to a 3rd biologic or higher.1-4 Due to a lack of evidence on the response to sequential therapies, individual patients may not have further lines routinely funded after three bDMARDs in the UK. While limiting lines of therapy remains a UK concern, many countries with rationed healthcare systems follow the UK model of drug usage.Objectives:To describe the response to sequential lines of bDMARD therapy prescribed in routine care in a UK single centre cohort.Methods:A retrospective sample of patients with PsA who fulfilled CASPAR criteria and had received at least one bDMARD were taken from the Bath longitudinal cohort for inclusion in the study. Clinical and laboratory variables that constitute physician and patient-reported outcome measures were collected at baseline and after a median (range) follow-up of 3 months (2-5) into their respective therapy line in accordance with the National Institute for Health and Care Excellence (NICE) rules. The mean change with a 95% confidence interval (CI) was used to report the difference between the baseline and follow-up measures. All patients provided consent to use their data collected during routine care, and ethical approval by the local committee was granted.Results:The patients mean age was 57.7 (SD 12.2) with a median (range) disease duration of 14.4 years (9.7 – 23.2). Data was available for 194 patients commencing 1st line bDMARD, 106 (2nd line), 93 (3rd line), 33 (4th line), 12 (5th line), and 9 (6th line and higher) from a total of 759 patients in the cohort. Mean tender and swollen joint count at baseline 1st bDMARD was 7 (SD 4.7) and 22 (SD 14.0), pain visual analogue scale 50 (SD 27.6) and PASI 1.3 (SD 2.2). Reasons for changing biological therapies include lack or loss of efficacy, intolerance, side effects, and comorbidities. Mean levels of joint disease at drug initiation did not diminish with subsequent lines of therapy. Clinical and patient reported outcomes by line of therapy are reported in Figure 1. Clinical responses were greatest to first line bDMARD, however clinically relevant DAPSA improvements were seen up to 5th line. Absolute levels of psoriasis in the cohort were low, however improvement in PASI was achieved across all lines of therapy. Patient and Physician Global Assessments (1-5 on Likert scale) and the Pain Visual analogue score (VAS on 1-10 Likert scale) showed a similar trend with greatest improvement to first line treatment across all lines of therapy.Conclusion:In this study we report the clinical response to sequential lines of bDMARD therapy for active PsA in routine clinical practice. Clinical response was greatest to the first line bDMARD but overall improvement in DAPSA, PASI or pain response did not appear to diminish up to 5th line. Further study in larger cohorts is required to confirm this finding and build on our understanding of clinical response to sequential lines of bDMARD therapy.References:[1]Hyrish et al 2006 Rheum 45, 1558-65[2]Kawabe A. 2020 Arth Res Ther 22, 136[3]Park DJ. 2017 Clin Rheum 36, 1013-22[4]Karlsson. 2007 JA Rheum 47,507-13Figure 1.Clinical and patient reported outcomes by line of therapyDisclosure of Interests:Abuelmagd Abdalla: None declared, Adwaye Rambojun: None declared, Laura C Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Gilead, Eli Lilly, Janssen, Medac, Novartis, Pfizer, and UCB., Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Pfizer, and Novartis, Eleanor Korendowych Consultant of: Abbvie, Celgene, Janssen, Lilly and Novartis., Neil McHugh: None declared, William Tillett Speakers bureau: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, Pfizer Inc., and UCB, Consultant of: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, MSD, Pfizer Inc., and UCB., Grant/research support from: AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc., and UCB.


2022 ◽  
pp. jrheum.200609
Author(s):  
Majed Mustafa Khraishi ◽  
Valencia P. Remple ◽  
Samuel Silverberg ◽  
Jacqueline C. Stewart ◽  
Brandusa Florica ◽  
...  

Objective COMPLETE-PsA was an observational study of biologic-naïve Canadian adults with active psoriatic arthritis (PsA) treated with adalimumab or a non-biologic disease-modifying antirheumatic drug (nbDMARDs) regimen, after inadequate response/intolerance to a current nbDMARD treatment regimen. The aim of this analysis was to assess 12-month effectiveness of adalimumab versus nbDMARDs. Methods Patients enrolled between March 2012 and November 2017 were included. The following clinical parameters and patient-reported outcomes were collected/calculated per routine care: DAPSA28, DAS28, ESR, CRP, MDGA, PtGA, pain, HAQ-DI, SF-12, enthesitis, dactylitis, BSA, and time to achieving ACR50, ACR70 and modified MDA (mMDA). Results Two hundred seventy-seven adalimumab-treated and 148 nbDMARD-treated patients were included. At baseline, adalimumab-treated patients were less likely to be employed; had longer morning stiffness; higher DAPSA28, DAS28, MDGA, PtGA, pain, and HAQ-DI; and lower prevalence of dactylitis (all p<0.05). Adalimumab-treated patients showed lower baseline-adjusted DAPSA28 (16.5 vs. 26.6), DAS28 (2.8 vs. 3.9), MDGA (25.3 vs. 37.1), and ESR (10.2 vs. 15.4 mm/hr) after 3 months compared to nbDMARD-treated patients, with observed improvements maintained to month 12. Time to achievement of ACR50, ACR70, and mMDA was significantly (p<0.01) shorter among adalimumab-treated patients, with the likelihood of having dactylitis [OR: 0.4 (0.2–0.6)] and BSA<3% [2.7 (1.5–5.0)] significantly lower and higher, respectively. Switching to another biologic was less likely in adalimumab-treated vs. nbDMARD -treated patients (HR [95% CI]: 0.3 [0.2-0.5]). Conclusion In a real-world Canadian PsA population, adalimumab was more effective than nbDMARDs at reducing disease activity and the severity of skin involvement and demonstrated higher retention.


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