scholarly journals The HOPE Pilot Study: Harnessing Patient-Reported Outcomes and Biometric Data to Enhance Cancer Care

2018 ◽  
pp. 1-12 ◽  
Author(s):  
Alexi A. Wright ◽  
Nikita Raman ◽  
Patrick Staples ◽  
Stephanie Schonholz ◽  
Angel Cronin ◽  
...  

Purpose Integrating patient-reported outcomes (PROs) into clinical practice is an increasingly promising strategy for improving patients’ symptoms, communication, and clinical outcomes. The objective of the current study was to assess the feasibility, acceptability, and perceived effectiveness of a mobile health intervention that was designed to collect PROs and activity data as a measure of health status. Patients and Methods This work was a pilot intervention with 10 patients with gynecologic cancers who received palliative chemotherapy. The HOPE (Helping Our Patients Excel) study used wearable accelerometers to assess physical activity and the Beiwe research platform to collect PROs, stratify patient responses by risk, provide tailored symptom management, and notify patients and clinicians of high-risk symptoms. Feasibility and acceptability were assessed through enrollment and adherence rates, and perceived effectiveness was evaluated by patients and oncologists at study completion. Results The approach-to-consent rate was 100%, and participants were 90% and 70% adherent to the wearable accelerometers and smartphone surveys, respectively. Participants’ mean daily step count was 3,973 (standard deviation [SD], 2,305 steps) and increased from week 1 (mean, 3,520 steps; SD, 1,937 steps) to week 3 (mean, 4,136 steps; SD, 1,578 steps). Active monitoring of participants’ heart rates, daily steps, and PROs throughout the study identified anomalies in participants’ behavior patterns that suggested poor health for two patients (20%). Patients and clinicians indicated that the intervention improved physical activity, communication, and symptom management. Conclusion A mobile health intervention that collects PROs and activity data as a measure of health status is feasible, acceptable, and was perceived to be effective in improving symptom management in patients with advanced gynecologic cancers. A larger, multisite, randomized clinical trial to assess the efficacy of the HOPE intervention on patients’ symptoms, health-related quality of life, clinical outcomes, and health care use is warranted.

2015 ◽  
Vol 3 ◽  
pp. 232640981557618 ◽  
Author(s):  
Christina Lampe ◽  
Mohit Jain ◽  
Andrew Olaye ◽  
Bianca Meesen ◽  
Celeste Decker ◽  
...  

2019 ◽  
Author(s):  
Anna L Beukenhorst ◽  
Kelly Howells ◽  
Louise Cook ◽  
John McBeth ◽  
Terence W O'Neill ◽  
...  

BACKGROUND Wearables provide opportunities for frequent health data collection and symptom monitoring. The feasibility of using consumer cellular smartwatches to provide information both on symptoms and contemporary sensor data has not yet been investigated. OBJECTIVE This study aimed to investigate the feasibility and acceptability of using cellular smartwatches to capture multiple patient-reported outcomes per day alongside continuous physical activity data over a 3-month period in people living with knee osteoarthritis (OA). METHODS For the KOALAP (Knee OsteoArthritis: Linking Activity and Pain) study, a novel cellular smartwatch app for health data collection was developed. Participants (age ≥50 years; self-diagnosed knee OA) received a smartwatch (Huawei Watch 2) with the KOALAP app. When worn, the watch collected sensor data and prompted participants to self-report outcomes multiple times per day. Participants were invited for a baseline and follow-up interview to discuss their motivations and experiences. Engagement with the watch was measured using daily watch wear time and the percentage completion of watch questions. Interview transcripts were analyzed using grounded thematic analysis. RESULTS A total of 26 people participated in the study. Good use and engagement were observed over 3 months: most participants wore the watch on 75% (68/90) of days or more, for a median of 11 hours. The number of active participants declined over the study duration, especially in the final week. Among participants who remained active, neither watch time nor question completion percentage declined over time. Participants were mainly motivated to learn about their symptoms and enjoyed the self-tracking aspects of the watch. Barriers to full engagement were battery life limitations, technical problems, and unfulfilled expectations of the watch. Participants reported that they would have liked to report symptoms more than 4 or 5 times per day. CONCLUSIONS This study shows that capture of patient-reported outcomes multiple times per day with linked sensor data from a smartwatch is feasible over at least a 3-month period. INTERNATIONAL REGISTERED REPORT RR2-10.2196/10238


2017 ◽  
Author(s):  
James Weatherall ◽  
Yurek Paprocki ◽  
Theresa M Meyer ◽  
Ian Kudel ◽  
Edward A Witt

BACKGROUND Few studies assessing the correlation between patient-reported outcomes and patient-generated health data from wearable devices exist. OBJECTIVE The aim of this study was to determine the direction and magnitude of associations between patient-generated health data (from the Fitbit Charge HR) and patient-reported outcomes for sleep patterns and physical activity in patients with type 2 diabetes mellitus (T2DM). METHODS This was a pilot study conducted with adults diagnosed with T2DM (n=86). All participants wore a Fitbit Charge HR for 14 consecutive days and completed internet-based surveys at 3 time points: day 1, day 7, and day 14. Patient-generated health data included minutes asleep and number of steps taken. Questionnaires assessed the number of days of exercise and nights of sleep problems per week. Means and SDs were calculated for all data, and Pearson correlations were used to examine associations between patient-reported outcomes and patient-generated health data. All respondents provided informed consent before participating. RESULTS The participants were predominantly middle-aged (mean 54.3, SD 13.3 years), white (80/86, 93%), and female (50/86, 58%). Use of oral T2DM medication correlated with the number of mean steps taken (r=.35, P=.001), whereas being unaware of the glycated hemoglobin level correlated with the number of minutes asleep (r=−.24, P=.04). On the basis of the Fitbit data, participants walked an average of 4955 steps and slept 6.7 hours per day. They self-reported an average of 2.0 days of exercise and 2.3 nights of sleep problems per week. The association between the number of days exercised and steps walked was strong (r=.60, P<.001), whereas the association between the number of troubled sleep nights and minutes asleep was weaker (r=.28, P=.02). CONCLUSIONS Fitbit and patient-reported data were positively associated for physical activity as well as sleep, with the former more strongly correlated than the latter. As extensive patient monitoring can guide clinical decisions regarding T2DM therapy, passive, objective data collection through wearables could potentially enhance patient care, resulting in better patient-reported outcomes.


2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Vittal Hejjaji ◽  
Zhuokai Li ◽  
David J Cohen ◽  
John Carroll ◽  
Sreekanth Vemulapalli ◽  
...  

Background: The goals of TAVR and transcatheter mitral valve repair (TMVr) are to prolong survival, reduce heart failure (HF) hospitalizations, and improve health status. Most patients report large improvements in health status within 30 days of these procedures. While this is an important patient-centered outcome on its own, if these changes were also associated with subsequent clinical outcomes, this would further support using short-term health status as a quality metric for valve procedures. Methods: Among patients who underwent transfemoral TAVR or TMVr, had KCCQ data at baseline and 30 days, and could be linked to CMS for 1-year outcomes; we constructed sequential models examining the association of KCCQ with death and HF hospitalization from 30 days to 1 year: 1) baseline KCCQ, 2) 30-day KCCQ, 3) baseline and 30-day KCCQ, 4) change in KCCQ from baseline to 30 days. In each model, we tested the interaction between procedure type and KCCQ, examined the linearity of the association of KCCQ with outcomes using restricted cubic splines, and adjusted for patient factors (Figure footnote). Results: Our cohort included 73,699 patients who underwent TAVR or TMVr from 2011-18 (median age 83 [IQR 77-87], 53% men, 92% TAVR). There were no significant interactions between procedure type and KCCQ, so all analyses used the combined cohort. Higher baseline KCCQ (model 1) and 30-day KCCQ (model 2) were both strongly associated with lower risk of death and HF hospitalization (Figure). When both were included in the model (model 3), each assessment was independently associated with subsequent outcomes, with the 30-day being most predictive. Change from baseline to 30 days was nonlinearly associated with outcomes (model 4), with increases up to 25 points associated with lower risk of death or HF hospitalization but no further risk reduction beyond 25 points. There were no meaningful changes in the associations after adjusting for patient factors. Conclusion: Short-term improvements in patient-reported health status after TAVR or TMVr were strongly associated with lower risk of death or HF hospitalization, with the 30-day assessment having a stronger association than baseline. These results support the routine use of 30-day KCCQ as a potential measure of quality after TVTs and to identify those at higher risk for adverse outcomes.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S861-S861
Author(s):  
Alan Oglesby ◽  
Kostas Angelis ◽  
Yogesh Punekar ◽  
Vasiliki Chounta ◽  
Antonio Antela ◽  
...  

Abstract Background The SWORD-1 and SWORD-2 studies previously demonstrated that high rates of virologic suppression were maintained for 148 weeks after switching virologically suppressed HIV-1 infected adults from their current 3- or 4-drug antiretroviral regimen (CAR) to the 2-drug regimen (2DR) of dolutegravir + rilpivirine on Day 1 (Early Switch (ES) DTG+RPV group). This abstract reports the pooled SWORD-1/2 results of patient reported outcomes (PRO) measures through Week 148. Methods HIV Treatment Satisfaction Questionnaire (HIVTSQ) and Symptom Distress Module (SDM) were secondary PRO endpoints in the SWORD trials. For HIVTSQ, high scores represent greater treatment satisfaction (range 0 to 60). SDM was assessed using the Symptom Bother Score with low values indicating less symptom bother (range 0 to 80). The EQ-5D-5L measure of general health status was assessed as an exploratory endpoint with maximum utility score of 1 to indicate perfect health. Change from Baseline in these endpoints was calculated for the ES subjects (over 148 weeks). Subjects randomized to CAR switched to DTG+RPV at Week 52 (Late Switch (LS) DTG+RPV group) and change from LS Baseline (i.e., last pre-switch assessment) was calculated (over 96 weeks). Results Low Symptom Bother (9.6 and 10.3) and high TSQ scores (54.4 and 54.3) were reported pre-switch in the ES and LS groups, respectively. ES subjects reported modest improvements from Baseline in both symptom burden and overall treatment satisfaction in all visits through Week 148 (Figures 1 and 2). Among the LS group, there was little change in symptom burden but similar improvement in treatment satisfaction. Pre-switch health status was high in ES and LS groups (EQ-5D mean utility: 0.96 and 0.94, respectively) and remained stable in both groups at all time points. Conclusion High treatment satisfaction and low symptom burden that were observed in patients under CAR were maintained long term after switching to DTG+RPV. These results corroborate DTG+RPV as a well-tolerated 2DR alternative treatment option in patients currently suppressed on other 3/4-drug regimens without previous virologic failure. Disclosures All authors: No reported disclosures.


BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e031166
Author(s):  
Hans-Peter van Jonbergen ◽  
Ellie Landman ◽  
Maarten Horst ◽  
Robin Westerbeek ◽  
Ydo Kleinlugtenbelt

IntroductionTotal knee replacement (TKR) for osteoarthritis results in a satisfactory outcome in the majority of patients, although up to one in five patients may be dissatisfied with the outcome. Persistent pain is a main contributor to patient dissatisfaction, and femoral and tibial component malrotation have been identified as a potential cause for both persistent pain and patellofemoral problems. Based on the assumption that component malrotation is the causative factor for persistent pain, early revision for patients with symptomatic malrotated components has been advocated in the literature. However, convincing evidence that component malrotation indeed results in less than optimal outcomes is lacking. This study aims to assess the relation between knee prosthesis component rotation and patient-reported outcomes in a large group of patients and to determine the range of femoral, tibial and combined rotation that results in the best clinical outcomes.Methods and analysisIn this single-centre, prospective observational cohort study, a total of 500 patients will undergo TKR. All patients will have a 3D-CT assessment of femoral and tibial component rotation within 8 weeks after surgery. Outcome measures will include the Oxford Knee Score, the Knee Injury and Osteoarthritis Outcome Score, EQ-5D, visual analogue scale for pain, the American Knee Society Score and the knee joint range of motion. We will assess the relation between femoral, tibial and combined component rotation and patient-reported outcome measures at 8 weeks and 1 year of follow-up, and we will determine the range of femoral, tibial and combined rotation that results in the best clinical outcomes.Ethics and disseminationEthical approval for this study has been granted by the Isala Hospital ethics committee. The results will be published in a peer-reviewed journal and presented at relevant meetings.Trial registration numberNL7635.


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