Outcomes Advanced Vk

[Mei Li Wu]

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Methods: The study used a nationwide cohort of 369,516 singleton pregnancies in Denmark followed from 11-14 weeks of gestation to delivery or termination of pregnancy. Pregnant women aged 35 years or older were divided into two advanced maternal age groups, 35-39 years and 40 years or older, and compared with pregnant women aged 20-34 years. Adverse pregnancy outcomes were chromosomal abnormalities, congenital malformations, miscarriage, stillbirth, and birth before 34 weeks of gestation. Multivariable logistic regression analyses were performed to investigate associations between advanced maternal age and adverse pregnancy outcomes. Furthermore, a risk prediction model for a composite adverse pregnancy outcome was made with prespecified predicting factors.

Conclusion: Women older than 40 years have a higher risk of chromosomal abnormalities, miscarriage, and birth before 34 weeks of gestation than younger women and should be monitored accordingly. No increased risk was observed for stillbirth and other congenital malformations. Several factors increase the risk of adverse pregnancy outcomes, but advanced maternal age drives a high proportion of the total risk score.

Introduction: Health-related quality of life (HRQOL) in advanced non-small-cell lung cancer (NSCLC) might be affected by the presence of brain metastasis (BM). We report findings from a prospective observational study that examined HRQOL in patients newly diagnosed with advanced NSCLC, with or without baseline BM, through 1 year of follow-up.

Patients and methods: Patients starting first-line treatment of stage IIIB/IV NSCLC were prospectively enrolled and consented at 34 US-based community oncology practices. Data on patient-reported outcomes (PROs) were collected once per cycle during treatment, and at each visit after discontinuation. PROs included the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (QLQ-LC13), the Lung Cancer Module of the M.D. Anderson Symptom Inventory (MDASI-LC), and the Rotterdam Activity Level Scale (RALS). Linear mixed models were used to examine the effect of baseline BM, including differences in change over time.

Conclusion: Newly diagnosed advanced NSCLC patients with baseline BM experienced a significantly faster and clinically meaningful deterioration in PRO-based HRQOL compared with those without baseline BM.

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Cancer patients require an accurate assessment of performance status and physical function to inform treatment decisions and determine eligibility into clinical trials. However, an objective evaluation of physical function and performance status is difficult because patients spend the majority of their time outside of the clinic, self-report to providers, and undergo dynamic changes throughout their treatment experience.

Recent technological advances in wearable activity monitors have made it possible to collect real-time, objective patient activity data in a non-obtrusive manner. Wearable activity monitors measure the duration, intensity, and frequency of physical activity and have previously been used in clinical settings to motivate exercise and behavior.13,14,15 Consumer-based wearable activity monitors, such as the Fitbit Charge HR are relatively inexpensive, simple devices that can be used to track physical activity including step counts, stairs climbed, calories, heart rate, and sleep.16,17,18 These will be referred to as activity metrics in this report. While previous studies have used wearable activity monitors for measuring adherence to a particular exercise intervention, or to motivate physical activity, their application for the assessment of patient functional and clinical outcomes has not previously been reported.15

Our primary objective was to measure the association between Fitbit Charge HR activity metrics and performance status. We also sought to measure the association between the wearable activity metrics and survival, the occurrence of serious adverse events, as well as the correlation between the wearable activity metrics and PROs in the domains of pain, physical functioning, and fatigue.

PROs were completed at each visit using NIH PROMIS scales: physical functioning, fatigue, pain, sleep, and emotional well-being. All 37 patients completed baseline PROMIS questionnaires and 31 patients completed the PROMIS questionnaires at end-of-study.

Step counts were the most reliable activity metrics to obtain from patients where all 37 patients had recorded step counts that were properly synced to their device. Heart rate and sleep data were missing in three patients due to syncing errors or removal of device during sleep. Based on individual patient responses in the exit interview, patients described their participation in the study as a positive experience and they considered the device easy to use, unobtrusive, and motivating (Table 4). Common complaints included: difficulty putting on and removing due to the style of the band clasp, not being waterproof, and flashing green light being distracting during sleep. Selected patient responses from the exit interview are provided in Table 4.

We examined the use of a consumer-based, wearable activity monitor to assess provider-assessed performance status, PROs, and survival in advanced cancer patients. We found that the wearable activity monitor was feasible for use, especially for the estimation of step counts over a short period of time. The statistically significant correlations observed between objectively measured wearable activity data and validated performance status scales, namely ECOG-PS and KPS, were consistent with our proposed hypothesis that the collection of wearable activity monitor data could supplement clinical evaluation of performance status. Importantly, the activity data suggested a trend for the prediction of clinically relevant adverse events, 30-day morbidity, and 6-month survival. We also observed correlations between wearable activity monitor metrics and PROs including physical functioning, pain, fatigue, and emotional distress.

Our findings provide new information regarding the use of an emerging technology in cancer clinical settings. While other cancer clinical trials have used wearable activity monitors (e.g., pedometers, biosensors, accelerometers) for the objective measurement of physical activity,14,15,16 the use of wearable activity monitors to correlate with functional and clinical outcomes are only beginning to be reported. As a result of the increase in use of wearable activity monitors in clinical settings, there are new oncology trials being developed or currently ongoing that are exploring the use of biosensors with broader applications.15,19,20,21,22,23 One such study evaluated the feasibility of the Garmin fitness tracker for predicting hospitalization in cancer patients undergoing concurrent chemotherapy and radiation therapy with curative intent.23 Authors reported that patients walked on average 5103 steps per day and an increase in 1000 steps per day was associated with a 38% reduction in risk for hospitalization. These findings were consistent with our own and supported the conclusion that objective activity monitoring in cancer patients is feasible and may be used to predict clinical outcomes such as hospitalization, although this would have to be explored in a larger randomized trial. Clinical trials from other chronic disease areas, such as chronic obstructive pulmonary disease, have also explored the use for wearable activity monitors to track and obtain objective measures of activity and reported their utility in a clinical setting.24,25,26 Thus, while our findings are described within the context of cancer clinical trials, the use of wearable activity monitors for the assessment of physical function and outcome prediction can be applied to broader healthcare settings.

Although limited by its small size and short duration, our trial included participants of varying ECOG-PS and KPS ratings allowing for activity estimates in each of the performance status categories. The majority of our participants were diagnosed with advanced pancreatic cancer disease. Thus, our patients tended to be sicker with poorer prognosis than what we may expect in other cancer groups. This also may explain the lower average PRO scores compared to the standard cancer population and a higher number of adverse events, hospitalizations, and deaths observed during the short study period. While this may limit the generalizability of our findings to healthier and earlier-stage cancer patients and survivors, our findings address a current research gap regarding the use of wearable activity monitors in sick and advanced cancer population. Our population was relatively homogeneous in terms of overall health and treatment schedules adding confidence to our findings and allowing us to show feasibility in a more advanced cancer population. Future studies should enroll more patients from multiple disease sites and stages to further generalize our findings to a broader cancer population. Finally, while device validation will always be a challenge inherent to the use of consumer-based wearable activity monitors in research, the Fitbit Charge HR has been validated for clinical use, and the accuracy of all wearable activity monitors will continue to improve over time.28,29,30,31,32,33

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