Tailored support may reduce mental and relational impact of infertility on infertile patients and partners.

RESEARCH QUESTION: What is the psychological impact of infertility on infertile patients and partners of infertile patients? DESIGN: This online, international, quantitative survey assessed the impact of infertility on mental health, relationships and daily activities for 1944 respondents. Respondents were male or female infertile patients (n = 1037) or partners to infertile patients (n = 907; not necessarily partners of the patient sample) and were recruited at different stages of the treatment journey. RESULTS: The most common emotions were 'sadness' at infertility diagnosis and 'anxiety' during treatment. Emotions differed in nature and intensity throughout the journey. Envy of others who achieved pregnancy was frequently reported by women. More than half of respondents (60.4%; n = 1174) perceived the infertility journey to have impacted their mental health, and 44.1% (n = 857) of respondents sought mental health support. More patients reported mental health impacts (70.1%, n = 727) than partners (49.3%, n = 447). One in three respondents indicated that their relationship had suffered due to the infertility diagnosis. Of these respondents, 55.0% (n = 409) strongly agreed that infertility caused an emotional strain. Patients more often than partners reported a detrimental impact on daily activities. Respondents most commonly agreed with statements regarding an 'effect on work-life balance'. CONCLUSION: Treatment journey stages are defined by their impact profile, which differs between infertile patients and partners of infertile patients. Negative impacts are diverse (mental health, relational, daily activities). There was disparity between the number of respondents reporting mental health issues and the number seeking mental health support. This indicates the need for support services tailored to different treatment stages.

Barriers and factors associated with significant delays to initial consultation and treatment for infertile patients and partners of infertile patients.

RESEARCH QUESTION: What are the key drivers and barriers for infertile patients and their partners to see an infertility specialist and initiate treatment? DESIGN: An online, international, 30-minute quantitative survey collected data from 1944 respondents from nine countries. Respondents were infertile patients (n = 1037) or partners of infertile patients (n = 907; but not necessarily partners of the patient sample), at different stages of the treatment journey. RESULTS: The overall average times were 3.2 years to receiving a medical infertility diagnosis, 2.0 years attempting to achieve pregnancy without assistance before treatment, and 1.6 years of treatment before successful respondents achieved pregnancy. The most common driver for considering treatment after a consultation (n = 1025) was an equal desire within the couple to have a child (40.8%). Of the partners (n = 356), 29.8% reported that transparency of information from healthcare professionals about treatment expectations was important. A significantly higher proportion of respondents seeking treatment reported that healthcare professionals offered supportive services (61.2%) and mental health services (62.0%), than of the 207 respondents who did not seek treatment (32.4% and 36.7%, respectively; P < 0.001). Perceived cost was the most commonly reported barrier for respondents not seeking a consultation (37.5% of n = 352) or treatment (42.0% of n = 207). Of the 95 respondents who discontinued treatment, 34.7% discontinued due to the financial impact. CONCLUSIONS: Respondents reported significant delays to seeking treatment, probably negatively impacting the chances of achieving pregnancy. Motivational coherence within couples was a key driver and cost of treatment was the main barrier. Reported supportive service offerings by healthcare professionals were significantly associated with continuation of the treatment journey.

A multitrait, multimethod matrix approach for a consumer-grade wrist-worn watch measuring sleep duration and continuity.

STUDY OBJECTIVES: We examined associations between self-reports about typical sleep patterns and sleep data derived from a wearable device worn on a nightly basis for a prolonged period (mean = 214 nights). We hypothesized that sleep characteristics would correlate better across different methods of assessment (self-report versus wearable) than they would correlate within the same method, a classic psychometric approach (multitrait, multimethod matrix). METHODS: A cross-national sample of 6,230 adult wearable users completed a brief sleep questionnaire collecting data on sleep duration and number of awakenings (NAW) and provided informed consent to link their responses to data from their wearable watches. The data collection for the wearable occurred over 12 months and the sleep questionnaire was completed subsequent to that. RESULTS: Results indicated a large (r = .615) correlation between sleep duration as assessed with the wearable and by self-report. A medium-to-large correlation (r = .406) was also seen for NAW. The multitrait, multimethod matrix suggested minimal method variance, i.e. similar "traits" (sleep duration and NAW) correlated across methods but within a given method, and such "traits" were generally unrelated. CONCLUSIONS: The results suggest that the longer period of data collection with the wearable generates more stable estimates of sleep than have been reported in most studies of actigraphy. Alternatively, the data might imply that individuals modify their self-reports about sleep via daily feedback to align their perceptions to the output of the wearable.

A large survey of nocturia related to sleep quality and daytime quality of life in a young Japanese population: NOCTURNE study.

AIMS: Nocturia, due to nocturnal polyuria and other conditions associated with nocturnal voiding, affects sleep quality and daytime quality of life (QOL). We aimed to investigate the relationship among nocturia, sleep quality, and daytime QOL in a young Japanese population. METHODS: This epidemiological study analyzed data from a retrospective data set containing sleep data from wearable devices worn by 9446 Japanese users and a prospective data set containing answers to a 10-item questionnaire completed by a subset of 605 users in the retrospective dataset. We recorded the first uninterrupted sleep period (FUSP), total sleep time (TST), number of nocturnal voids, sleep quality, daytime QOL, bothering nocturnal voids, and early wake-ups in the morning. RESULTS: The subjects were 18-65 years old. The mean TST was 6.7 ± 0.9 h, and the mean number of wake-ups was 2.11 ± 1.1. FUSP and TST decreased (from 334 ± 114 to 173 ± 74 min and 5.9 ± 1.0 to 5.5 ± 1.0 h, respectively) with an increasing number of nocturnal voids, and the change was statistically significant. Logistic regression analysis showed a statistically significant relationship between nocturia and FUSP and the number of wake-ups. CONCLUSION: Nocturia has close relationships with FUSP and the number of wake-ups and can result in decreased daytime QOL in young Japanese people.

Night-time voids, level of bother and sleep characteristics in a non-patient population of wearable devices users.

INTRODUCTION: Nocturia is a highly prevalent and bothersome medical condition characterised mainly by the need to wake up to pass urine during the main sleep period. Using data from wearable devices, it is possible to examine the sleep of large cohorts in natural settings. This study seeks to use data from connected smartwatches combined with a one-time survey to explore the presence of nocturia and associated level of bother and sleep characteristics in a non-patient cohort of wearable device users representing a broad age range. METHODS: The data used come from a retrospective dataset containing sleep data from Withings watches of 250 000 users and a prospective dataset containing answers to a 10-item questionnaire completed by a subset of users in the retrospective dataset. RESULTS: The prospective dataset contained 6230 users. Overall, 6.0%, 15.3% and 38.9% of users in the age groups 18-44 years, 45-64 years and 65-90 years, respectively, reported 2 or more nocturnal voids as their customary voiding pattern, corresponding to levels of nocturia consistent with previous literature. The level of bother associated with nocturia was higher among younger users with 27.8% of users aged 18-44 years reporting that their daytime activity was highly affected versus just 14.1% among those aged 65-90 years. A higher number of reported voids per night was associated with watch-derived measures of a lower sleep efficiency, a longer awake duration at night and a shorter first uninterrupted sleep period. CONCLUSION: This study suggests not only that nocturia is present among the younger population but also that the younger are more bothered by this medical condition. Using data from wearables it was possible to establish that there is an association between the number of nocturnal voids and sleep characteristics.

Feasibility and Health Benefits of an Individualized Physical Activity Intervention in Women With Metastatic Breast Cancer: Intervention Study.

BACKGROUND: There is limited knowledge regarding the potential benefits of physical activity in patients with metastatic breast cancer. OBJECTIVE: The Advanced stage Breast cancer and Lifestyle Exercise (ABLE) Trial aimed to assess the feasibility of a physical activity intervention in women with metastatic breast cancer and to explore the effects of physical activity on functional, psychological, and clinical parameters. METHODS: The ABLE Trial was a single-arm, 6-month intervention study with a home-based, unsupervised, and personalized walking program using an activity tracker. At baseline and 6 months, we assessed anthropometrics, functional fitness, physical activity level, sedentary behavior, quality of life, fatigue, and tumor progression. Paired proportions were compared using the McNemar test and changes of parameters during the intervention were analyzed using the Wilcoxon signed-rank test, the Mann-Whitney test, and Spearman rank correlations. RESULTS: Overall, 49 participants (mean age 55 years; recruitment rate 94%) were enrolled and 96% adhered to the exercise prescription (attrition rate 2%). Statistically significant improvements in the 6-minute walking distance test (+7%, P<.001) and isometric quadriceps strength (+22%, P<.001), as well as decreases in body mass index (-2.5%, P=.03) and hip circumference (-4.0%, P<.001) were observed at 6 months. Quality of life remained stable and a nonstatistically significant decrease (-16%, P=.07) in fatigue was observed. CONCLUSIONS: The high recruitment and adherence rates suggest the willingness of patients with metastatic breast cancer to participate in a physical activity program. The beneficial outcomes regarding physical fitness and anthropometry of this unsupervised physical activity program may encourage these patients to maintain a physically active lifestyle. Future randomized controlled trials with larger sample sizes are warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT03148886; https://clinicaltrials.gov/ct2/show/NCT03148886.

Middle-Aged Men With HIV Have Diminished Accelerometry-Based Activity Profiles Despite Similar Lab-Measured Gait Speed: Pilot Study.

BACKGROUND: People aging with HIV are living with increased risk for functional decline compared with uninfected adults of the same age. Early preclinical changes in biomarkers in middle-aged individuals at risk for mobility and functional decline are needed. OBJECTIVE: This pilot study aims to compare measures of free-living activity with lab-based measures. In addition, we aim to examine differences in the activity level and patterns by HIV status. METHODS: Forty-six men (23 HIV+, 23 HIV-) currently in the MATCH (Muscle and Aging Treated Chronic HIV) cohort study wore a consumer-grade wristband accelerometer continuously for 3 weeks. We used free-living activity to calculate the gait speed and time spent at different activity intensities. Accelerometer data were compared with lab-based gait speed using the 6-minute walk test (6-MWT). Plasma biomarkers were measured and biobehavioral questionnaires were administered. RESULTS: HIV+ men more often lived alone (P=.02), reported more pain (P=.02), and fatigue (P=.048). In addition, HIV+ men had lower blood CD4/CD8 ratios (P<.001) and higher Veterans Aging Cohort Study Index scores (P=.04) and T-cell activation (P<.001) but did not differ in levels of inflammation (P=.30) or testosterone (P=.83). For all participants, accelerometer-based gait speed was significantly lower than the lab-based 6-MWT gait speed (P<.001). Moreover, accelerometer-based gait speed was significantly lower in HIV+ participants (P=.04) despite the absence of differences in the lab-based 6-MWT (P=.39). HIV+ participants spent more time in the lowest quartile of activity compared with uninfected (P=.01), who spent more time in the middle quartiles of activity (P=.02). CONCLUSIONS: Accelerometer-based assessment of gait speed and activity patterns are lower for asymptomatic men living with HIV compared with uninfected controls and may be useful as preclinical digital biomarkers that precede differences captured in lab-based measures.

A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial.

BACKGROUND: About 5% of breast cancer cases are metastatic at diagnosis, and 20%-30% of localized breast cancer cases become secondarily metastatic. Patients frequently report many detrimental symptoms related to metastasis and treatments. The physical, biological, psychological, and clinical benefits of physical activity during treatment in patients with localized breast cancer have been demonstrated; however, limited literature exists regarding physical activity and physical activity behavior change in patients with metastatic breast cancer. OBJECTIVE: The primary objective of this study is to assess the feasibility of a 6-month physical activity intervention with activity trackers in patients with metastatic breast cancer (the Advanced stage Breast cancer and Lifestyle Exercise, ABLE Trial). Secondary objectives are to examine the effects of physical activity on physical, psychological, anthropometrics, clinical, and biological parameters. METHODS: We plan to conduct a single-center, single-arm trial with 60 patients who are newly diagnosed with metastatic breast cancer. Patients will receive an unsupervised and personalized 6-month physical activity program that includes an activity tracker Nokia Go and is based on the physical activity recommendation. Patients will be encouraged to accumulate at least 150 minutes per week of moderate-to-vigorous intensity physical activity. Baseline and 6-month assessments will include anthropometric measures, functional tests (eg, 6-minute walk test and upper and lower limb strength), blood draws, patient-reported surveys (eg, quality of life and fatigue), and clinical markers of tumor progression (eg, Response Evaluation Criteria In Solid Tumors criteria). RESULTS: Data collection occurred between October 2016 and January 2018, and the results are expected in August 2018. CONCLUSIONS: The ABLE Trial will be the first study to assess the feasibility and effectiveness of an unsupervised and personalized physical activity intervention performed under real-life conditions with activity trackers in patients with metastatic breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT03148886; https://clinicaltrials.gov/ct2/show/NCT03148886 (Accessed by WebCite at http://www.webcitation.org/71yabi0la). REGISTERED REPORT IDENTIFIER: RR1-10.2196/10487.

Patient stratification and identification of adverse event correlations in the space of 1190 drug related adverse events.

PURPOSE: New pharmacovigilance methods are needed as a consequence of the morbidity caused by drugs. We exploit fine-grained drug related adverse event information extracted by text mining from electronic medical records (EMRs) to stratify patients based on their adverse events and to determine adverse event co-occurrences. METHODS: We analyzed the similarity of adverse event profiles of 2347 patients extracted from EMRs from a mental health center in Denmark. The patients were clustered based on their adverse event profiles and the similarities were presented as a network. The set of adverse events in each main patient cluster was evaluated. Co-occurrences of adverse events in patients (p-value < 0.01) were identified and presented as well. RESULTS: We found that each cluster of patients typically had a most distinguishing adverse event. Examination of the co-occurrences of adverse events in patients led to the identification of potentially interesting adverse event correlations that may be further investigated as well as provide further patient stratification opportunities. CONCLUSIONS: We have demonstrated the feasibility of a novel approach in pharmacovigilance to stratify patients based on fine-grained adverse event profiles, which also makes it possible to identify adverse event correlations. Used on larger data sets, this data-driven method has the potential to reveal unknown patterns concerning adverse event occurrences.