A digital therapeutic for proactive monitoring of patients on immune checkpoint inhibitor therapy for early detection of immune-related adverse events.

2020 ◽  
Vol 38 (5_suppl) ◽  
pp. 101-101
Author(s):  
Shyamali Mallick Singhal ◽  
Shane Dormady ◽  
Jiali Li ◽  
Shiva Singhal ◽  
Lynda Chin
Keyword(s):  
Early Detection ◽  
Adverse Events ◽  
Clinical Care ◽  
Patient Reported Outcome ◽  
Feasibility Trial ◽  
Cancer Center ◽  
Evidence Based ◽  
Close Monitoring ◽  
Patient Reported ◽  
Proactive Monitoring

101 Background: Immune-related adverse events (irAEs) occur frequently in patients receiving immuno-oncology therapy. irAEs are heterogeneous and unpredictable. Experience at academic cancer centers has shown that (1) education of patients and families must be continuous; (2) experience of the care team can improve outcomes; and (3) close monitoring of patients in between visits translate into early detection and timely intervention. Most oncologists in lower volume community practices have not gained the experience nor have the resource for continuous education frequent proactive monitoring. Methods: In addition to self-monitoring by patients on chemotherapy to improve outcome (Basch ref), we hypothesized that adoption of evidence-based management is critical as well. Thus, we have developed ApricityRx, a digital therapeutic (DTx) for end-to-end irAE management, which not only engages patients in frequent self-nonitoring but also activates the oncology team for timely intervention. In brief, ApricityRx (i) enables intelligent monitoring by educating and guiding patients to track specific expert-prioritized symptoms in between clinic visits; (ii) facilitates early recognition by prompting triage at the right time and (iii) recommends evidence-based management based on consensus guidelines. Results: In a community cancer center, 16 patients have been enrolled (44% consent rate) in an IRB approved feasibility trial to evaluate the usability of ApricityRx as a tool for frequent monitoring and timely triage. Over 435 unique longitudinal records containing over 34K data points, including patient-reported outcome (PRO) and clinical care data (EMR), were generated. Interim analyses have shown that primary and secondary endpoints were met. Detailed results will be presented. Conclusions: ApricityRx has shown usability in a low-volume community-based oncology practice to facilitate proactive monitoring and tinely triage by the oncology team. Further, ApricityRx has enabled not only generation of high-resolution patient-reported outcome (PRO) data, but also aggregation of PRO and real-world EHRs data for downstream analyses.

scholarly journals Reduced Time to Surgery Improves Patient-Reported Outcome After Achilles Tendon Rupture

2018 ◽  
Vol 46 (12) ◽  
pp. 2929-2934 ◽  
Author(s):  
Simon Svedman ◽  
Robin Juthberg ◽  
Gunnar Edman ◽  
Paul W. Ackermann
Keyword(s):  
Patient Outcome ◽  
Adverse Events ◽  
Achilles Tendon ◽  
Tendon Rupture ◽  
Achilles Tendon Rupture ◽  
Patient Reported Outcome ◽  
Evidence Based ◽  
Treatment Protocols ◽  
Good Outcome ◽  
Patient Reported

Background: Patient outcome after an acute Achilles tendon rupture (ATR) continues to be suboptimal and heterogeneous. Thus, prognostic factors are called for to optimize evidence-based ATR treatment protocols; however, the influence of delayed time from injury to surgery (TTS) on patient outcome after ATR remains largely unknown. Purpose: To determine whether patient outcomes and adverse events after surgical repair of acute ATR are related to delayed TTS. Study Design: Cohort study; Level of evidence, 3. Methods: Two hundred twenty-eight patients with ATR who were treated with uniform anesthetic and surgical techniques, within 10 days after injury, were retrospectively assessed. TTS depended on availability of the operating theater, and neither surgeon nor patient could influence the TTS. Patients were assigned to 1 of 3 groups: short TTS (<48 hours), intermediate TTS (48-72 hours), and long TTS (>72 hours). Patient-reported outcome at 1 year was assessed with the validated Achilles tendon Total Rupture Score, with scores higher than 80 on a 0- to 100-point scale indicating an overall good outcome. The incidences of adverse events (perioperative and postoperative) and deep venous thrombosis were assessed. Results: Short TTS was significantly associated with increased rate of good outcome and reduced risk of adverse events. Seventy-one percent (95% CI, 60%-83%) of the patients with short TTS attained a good outcome compared with 44% (95% CI, 33%-56%) of the patients with long TTS ( P = .002), with the intermediate TTS group in between, 63% (95% CI, 47%-78%). The incidence of adverse events was significantly reduced among patients with short TTS, 1.4% (95% CI, 1%-4%) compared with those with intermediate TTS, 11% (95% CI, 2%-21%) ( P = .035) and those with long TTS, 14.8% (95% CI, 7%-23%) ( P = .003). The risk of sustaining a deep venous thrombosis was not statistically significantly different among the 3 groups ( P = .15). Conclusion: Patients with acute ATR undergoing operation within 48 hours after injury had better outcomes and a lower number of adverse events compared with patients undergoing operation after 72 hours. These results align with evidence-based recommendations from other surgical disciplines and should be used as guidelines for optimizing ATR treatment protocols. Registration: NTC01317160 (ClinicalTrials.gov identifier).

Successes with and barriers to patient-reported outcome deployment at a comprehensive cancer center.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 292-292
Author(s):  
Nadine Jackson McCleary ◽  
Deborah Schrag ◽  
Neil E. Martin ◽  
Sadiqa Mahmood ◽  
Elizabeth Beyer ◽  
...  
Keyword(s):  
Adverse Events ◽  
Assessment Tool ◽  
Treatment Plan ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Patient Reported ◽  
Oncology Practice ◽  
Plan Modification

292 Background: Routine collection of patient reported outcomes (PROs) reduces hospitalizations and improves quality of life. In the absence of clear implementation guidelines and research guiding deployment, PROs may not have the desired impact on outcomes in routine oncology practice. We share lessons learned from PRO deployment at Dana-Farber Cancer Institute. Methods: We developed a symptom/toxicity assessment tool based on the PRO-CTCAE to capture 15 symptomatic adverse events with a 1-week recall: fatigue/ decreased appetite/insomnia/ shortness of breath/numbness and tingling/concentration, general pain/anxiety/sadness, rash, nausea/vomiting/fever, constipation, and diarrhea. Responses from eligible English-literate patients scheduled for a gastrointestinal cancer center or adult palliative care visit between January 18 to March 22, 2018 were transmitted directly from clinic tablet to the EMR. To evaluate the deployment, we sought qualitative feedback from clinic staff and three multidisciplinary working groups comprised of patients, nurses, pharmacists, operations leaders, quality/safety experts, and health services researchers to identify technical and workflow gaps in PRO Content, Implementation, and Analytics. Results: We noted a 38% response rate of the N = 4440 PROs assigned to N = 4440 scheduled visits for N = 2055 unique patients (36% were completed, 2% started but not completed); 62% were not started. Workflow enhancement requests include an updated summary view, a clinical documentation tool, a scoring algorithm to highlight severe responses, and a quality metric dashboard to evaluate the deployment. Ongoing analyses are studying the proportion of moderate-severe symptomatic adverse events reported and their association with provider action (i.e., supportive care referral, chemotherapy treatment plan modification, or unplanned ED/hospitalization in the subsequent 30 days). Conclusions: Refinement of the PRO deployment strategy is needed to guide implementation efforts and demonstrate meaningful impact in routine oncology practice.

scholarly journals Electronic patient-reported outcomes and machine learning in predicting immune-related adverse events of immune checkpoint inhibitor therapies

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sanna Iivanainen ◽  
Jussi Ekstrom ◽  
Henri Virtanen ◽  
Vesa V. Kataja ◽  
Jussi P. Koivunen
Keyword(s):  
Machine Learning ◽  
Early Detection ◽  
Adverse Events ◽  
Cancer Patients ◽  
Immune Checkpoint ◽  
Patient Reported Outcomes ◽  
Prediction Models ◽  
Accuracy Score ◽  
Patient Reported ◽  
Auc Value

Abstract Background Immune-checkpoint inhibitors (ICIs) have introduced novel immune-related adverse events (irAEs), arising from various organ systems without strong timely dependency on therapy dosing. Early detection of irAEs could result in improved toxicity profile and quality of life. Symptom data collected by electronic (e) patient-reported outcomes (PRO) could be used as an input for machine learning (ML) based prediction models for the early detection of irAEs. Methods The utilized dataset consisted of two data sources. The first dataset consisted of 820 completed symptom questionnaires from 34 ICI treated advanced cancer patients, including 18 monitored symptoms collected using the Kaiku Health digital platform. The second dataset included prospectively collected irAE data, Common Terminology Criteria for Adverse Events (CTCAE) class, and the severity of 26 irAEs. The ML models were built using extreme gradient boosting algorithms. The first model was trained to detect the presence and the second the onset of irAEs. Results The model trained to predict the presence of irAEs had an excellent performance based on four metrics: accuracy score 0.97, Area Under the Curve (AUC) value 0.99, F1-score 0.94 and Matthew’s correlation coefficient (MCC) 0.92. The prediction of the irAE onset was more difficult with accuracy score 0.96, AUC value 0.93, F1-score 0.66 and MCC 0.64 but the model performance was still at a good level. Conclusion The current study suggests that ML based prediction models, using ePRO data as an input, can predict the presence and onset of irAEs with a high accuracy, indicating that ePRO follow-up with ML algorithms could facilitate the detection of irAEs in ICI-treated cancer patients. The results should be validated with a larger dataset. Trial registration Clinical Trials Register (NCT3928938), registration date the 26th of April, 2019

scholarly journals Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e041626
Author(s):  
Jamie M Jacobs ◽  
Chelsea S Rapoport ◽  
Arielle Horenstein ◽  
Madison Clay ◽  
Emily A Walsh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Symptom Management ◽  
Adjuvant Endocrine Therapy ◽  
Feasibility Trial ◽  
Cancer Center ◽  
Control Group ◽  
Evidence Based ◽  
Pill Bottle ◽  
Randomised Controlled

IntroductionPatient adherence to adjuvant endocrine therapy (AET) after a diagnosis of hormone-sensitive breast cancer is poor. Previous interventions have failed to produce changes in adherence, address patient preferences or include theoretically informed and evidence-based components. Therefore, we iteratively developed a patient-centred, evidence-based, small-group, videoconference intervention to improve adherence and symptom management as well as reduce distress for patients taking AET after breast cancer (Symptom-Targeted Randomised Intervention for Distress and Adherence to Adjuvant Endocrine Therapy, STRIDE).Methods and analysisThe current study is a non-blinded, randomised, controlled, feasibility trial of STRIDE compared with a medication monitoring control group. The primary objective is to examine the feasibility and acceptability of STRIDE, while secondary objectives are to assess changes in objective and subjective adherence, symptom distress and satisfaction with AET. Patients will be recruited from the Massachusetts General Hospital Cancer Center in Boston, Massachusetts. The total number of patients accrued will be 75, with ≥60 patients completing the study. All patients will store their AET in an electronic pill bottle for objective adherence monitoring. Patients randomly assigned to the STRIDE intervention will receive 6 weekly 1-hour sessions, in small groups of two, delivered via videoconferencing by a trained mental health professional. Patients assigned to the control group will store their medication in the electronic pill bottle and receive follow-up oncology care as usual. All participants will complete self-report psychosocial measures at baseline, 12 weeks and 24 weeks postbaseline.Ethics and disseminationThe study is funded by the National Cancer Institute of the National Institutes of Health and is approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board (Protocol #18–603, V.1.2, first approval date 1 February 2019). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. Results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patient organisations and media outlets.Trial registration numberNCT03837496; Pre-results.

scholarly journals Capturing PROMs in Oncology Through Consistent Nutrition Risk Identification: An Opportunity to Optimize Care by Embedding Patient Participation Facilitated by eHealth Tools

2021 ◽  
pp. 1-2
Author(s):  
Susana  Couto Irving 
Keyword(s):  
Outcome Measures ◽  
Patient Participation ◽  
Cancer Care ◽  
Clinical Care ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Risk Identification ◽  
Nutrition Status ◽  
Pancreatic Tumors ◽  
Patient Reported

Patient-reported outcome measures obtained via E-Health tools ease the assessment burden and encourage patient participation in cancer care (PaCC Study). <b>Background:</b> E-health based patient-reported outcome measures (PROMs) have the potential to automate early identification of both nutrition status and distress status in cancer patients while facilitating treatment and encouraging patient participation. This cross-sectional study assessed the acceptability, accuracy, and clinical utility of PROMs collected via E-Health tools among patients undergoing treatment for stomach, colorectal, and pancreatic tumors. <b>Results:</b> Eight-nine percent mostly, or completely, agreed that PROMs via tablets should be integrated in routine clinical care. Men were significantly more likely to require help completing the questionnaires than women (inv.OR = 0.51, 95% CI = (0.27, 0.95), p = 0.035). The level of help needed increased by 3% with each 1-year increase in age (inv. OR = 1.03, 95% CI = (1.01, 1.06), p = 0.013). On average, a patient tended to declare weight which was 0.84 kg inferior to their true weight (Bland and Altman 95 % CI = (–3.9, 5.6); SD: 2.41) and a height which was 0.95 cm superior to their true height (Bland and Altman 95 % CI = (−5, 3.1); SD 2.08). Patient-reported nutrition status was significantly associated with the professionally generated assessment (95% CI = (2.27, 4.15), p &#x3c; 0.001). As nutrition status declined, the distress score increased (95%CI = (0.88, 1.68), p &#x3c; 0.001). Of the patients, 48.8% who were both distressed and malnourished requested supportive care to address their problems. <b>Conclusion:</b> Patient-reported assessments utilizing E-health tools are an accurate and efficient method to encourage patient participation in cancer care while simultaneously ensuring that regular assessment of psycho-social and nutritional aspects of care are efficiently integrated in the daily clinical routine.

scholarly journals Harmonizing evidence-based practice, implementation context, and implementation strategies with user-centered design: a case example in young adult cancer care

2020 ◽  
Author(s):  
Emily R Haines ◽  
Alex Dopp ◽  
Aaron R. Lyon ◽  
Holly O. Witteman ◽  
Miriam Bender ◽  
...  
Keyword(s):  
Young Adult ◽  
Outcome Measure ◽  
Implementation Strategies ◽  
Patient Reported Outcome ◽  
Evidence Based ◽  
User Centered Design ◽  
Evidence Based Practices ◽  
Patient Reported Outcome Measure ◽  
Patient Reported ◽  
User Centered

Abstract Background. Attempting to implement evidence-based practices in contexts for which they are not well-suited may compromise their fidelity and effectiveness or burden users (e.g., patients, providers, healthcare organizations) with elaborate strategies intended to force implementation. To improve the fit between evidence-based practices and contexts, implementation science experts have called for methods for adapting evidence-based practices and contexts, and tailoring implementation strategies; yet, methods for considering the dynamic interplay among evidence-based practices, contexts, and implementation strategies remain lacking. We argue that harmonizing the three can be accomplished with User-Centered Design, an iterative and highly stakeholder-engaged set of principles and methods. Methods. This paper presents a case example in which we used User-Centered Design methods and a three-phase User-Centered Design process to design a care coordination intervention for young adults with cancer. Specifically, we used usability testing to redesign an existing evidence-based practice (i.e., patient-reported outcome measure that served as the basis for intervention) to optimize usability and usefulness, an ethnographic user and contextual inquiry to prepare the context (i.e., comprehensive cancer center) to promote receptivity to implementation, and iterative prototyping workshops with a multidisciplinary design team to design the care coordination intervention and anticipate implementation strategies needed to enhance contextual fit. Results. Our User-Centered Design process resulted in the Young Adult Needs Assessment and Service Bridge (NA-SB), including a patient-reported outcome measure redesigned to promote usability and usefulness and a protocol for its implementation. By ensuring NA-SB directly responded to features of users and context, we designed NA-SB for implementation , potentially minimizing the strategies needed to address misalignment that may have otherwise existed. Furthermore, we designed NA-SB for scale-up ; by engaging users from other cancer programs across the country to identify points of contextual variation which would require flexibility in delivery, we created a tool not overly tailored to one unique context. Conclusions. User-Centered Design can help maximize usability and usefulness when designing evidence-based practices, preparing contexts, and informing implementation strategies- in effect, harmonizing evidence-based practices, contexts, and implementation strategies to promote implementation and effectiveness.

scholarly journals The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 100 (4) ◽  
pp. 662-676 ◽  
Author(s):  
Jenna C Gibbs ◽  
Caitlin McArthur ◽  
John D Wark ◽  
Lehana Thabane ◽  
Samuel C Scherer ◽  
...  
Keyword(s):  
Vertebral Fractures ◽  
Functional Performance ◽  
Physical Therapist ◽  
Controlled Trial ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Feasibility Trial ◽  
Home Exercise ◽  
Intention To Treat ◽  
Patient Reported

Abstract Background Regular exercise is advocated in osteoporosis guidelines to prevent fractures. Few studies have evaluated the effect of exercise on functional performance, posture, and other outcomes that are important to patients after vertebral fractures. Objective This pilot study will explore the effect of home exercise versus control on functional performance, posture, and patient-reported outcome measures. Design This study was a parallel 2-arm pilot feasibility trial with 1:1 randomization to exercise or attentional control groups. Setting This study took place in 5 Canadian and 2 Australian academic or community hospitals/centers. Participants This study included 141 women ≥65 years of age with radiographically confirmed vertebral fractures. Intervention A physical therapist delivered exercise and behavioral counseling in 6 home visits over 8 months and monthly calls. Participants were to exercise ≥3 times weekly. Controls received equal attention. Measurements Functional performance, posture, quality of life, pain, and behavior-change outcomes were assessed at baseline and after 6 (questionnaires only) and 12 months. Adherence to exercise was assessed by calendar diary. All t tests examined between-group mean differences (MD) in change from baseline in intention-to-treat and per-protocol analyses. Results There was a small effect of exercise on 5 times sit-to-stand test versus control (MD = −1.58 [95% CI = −3.09 to −0.07], intention-to-treat; MD = −1.49 [95% CI = −3.12 to 0.16], per-protocol). There were no other major or statistically significant MDs for any other measured outcomes after follow-up. Adherence declined over time. Limitations Treatment effects on variables may have been underestimated due to multiple comparisons and underpowered analyses. Conclusions Our exploratory estimate of the effect of exercise on functional leg muscle strength was consistent in direction and magnitude with other trials in individuals with vertebral fractures. Declining adherence to home exercise suggests that strategies to enhance long-term adherence might be important in future confirmatory trials.

Performance of the patient reported CAPLET2.0 physical functioning assessment tool.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 194-194
Author(s):  
Alexandra McCartney ◽  
Julia Singer ◽  
Reenika Aggarwal ◽  
Katrina Hueniken ◽  
Raiza Commiting ◽  
...  
Keyword(s):  
Physical Function ◽  
Cancer Patients ◽  
Physical Functioning ◽  
Assessment Tool ◽  
Performance Status ◽  
Patient Reported Outcome ◽  
Cancer Center ◽  
Patient Reported ◽  
Hematological Cancers ◽  
Screening Questions

194 Background: CAPLET is a published patient reported outcome measure which assesses domains of physical function efficiently in cancer patients through a branching logic algorithm using a patient-reported outcome version of ECOG performance status and EQ5D-3L health utility score (PMID: 29982902; a total of 6 screening questions). We assessed the sensitivity and specificity of this tool after updating it with screening questions from the EQ5D-5L (CAPLET2.0) as opposed to the previously published EQ5D-3L screener (CAPLET). Methods: Eligible cancer patients across all outpatient clinics and disease sites (solid and liquid cancers) at the Princess Margaret Cancer Center completed a questionnaire on touch-screen technology containing the EQ5D-5L, patient-reported outcome (PRO)-ECOG performance scale, the gold standard WHODAS 2.0 (12 items) and HAQ-DI (20 items) physical functioning questionnaires, and a clinico-demographic survey. Results: Of 261 patients, 53% were female, 61% were Caucasian, and 71% had English as a first language. Disease sites included: 12% breast, 10% gastrointestinal, 12% genitourinary, 19% gynecological, 13% head and neck, 13% lung and 13% hematological cancers. The optimal branching logic cut-points were identified when PRO-ECOG, scored as 0-1 and individual EQ5D items scored with the best functioning category allowed specific WHODAS/HAQ-DI questions to be skipped. Against individual WHODAS-HAQ-DI items, CAPLET2.0 had sensitivities ranging from 83-100% (median 93%), and specificities of 50-82% (median 58%). Using CAPLET 2.0, 45% of patients could have skipped all but five questions measuring mental health and cognition which are always asked. Sensitivities, specificities and the proportion of questions that could have been skipped were all similar to the original CAPLET tool. Conclusions: CAPLET2.0, which uses the updated EQ5D-5L and PRO-ECOG as screening questions to assess physical function in cancer patients has comparable performance to the original CAPLET tool. CAPLET2.0 is therefore a viable alternative physical functioning screening tool for both routine and research use.

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