Evaluation of atrial fibrillation using wearable device signals and home blood pressure data in the Michigan Predictive Activity & Clinical Trajectories in Health (MIPACT) Study: A Subgroup Analysis (MIPACT-AFib).

Background: The rising adoption of wearable technology increases the potential to identify arrhythmias. However, specificity of these notifications is poorly defined and may cause anxiety and unnecessary resource utilization. Herein, we report results of a follow-up screening protocol for incident atrial fibrillation/flutter (AF) within a large observational digital health study. Methods: The MIPACT Study enrolled 6,765 adult patients who were provided an Apple Watch and blood pressure (BP) monitors. From March to July 2019, participants were asked to contact the study team for any irregular heart rate (HR) notification. They were assessed using structured questionnaires and asked to provide 6 Apple Watch EKGs. Those with arrhythmias or non-diagnostic EKGs were sent 7-day monitors. The EHR was reviewed after 3 years to determine if participants developed arrhythmias. Results: 86 participants received notifications and met inclusion criteria. Mean age was 50.5 (SD 16.9) years, and 46 (53.3%) were female. Of 76 participants assessed by the study team, 32 (42.1%) reported anxiety surrounding notifications. Of 59 participants who sent at least 1 EKG, 52 (88.1%) were in sinus rhythm, 3 (5.1%) AF, 2 (3.4%) indeterminate, and 2 (3.4%) sinus bradycardia. Cardiac monitor demonstrated AF in 2 of 3 participants with AF on Apple Watch EKGs. 2 contacted their PCPs and were diagnosed with AF. In total, 5 cases of AF were diagnosed with 1 additional case identified during EHR review. Conclusion: Wearable devices produce alarms that can frequently be anxiety provoking. Research is needed to determine the implications of these alarms and appropriate follow-up.

Wearable device signals and home blood pressure data across age, sex, race, ethnicity, and clinical phenotypes in the Michigan Predictive Activity & Clinical Trajectories in Health (MIPACT) study: a prospective, community-based observational study.

BACKGROUND: Wearable technology has rapidly entered consumer markets and has health-care potential; however, wearable device data for diverse populations are scarce. We therefore aimed to describe and compare key wearable signals (ie, heart rate, step count, and home blood pressure measurements) across age, sex, race, ethnicity, and clinical phenotypes. METHODS: In the Michigan Predictive Activity & Clinical Trajectories in Health (MIPACT) prospective observational study, we enrolled participants from Michigan Medicine, Ann Abor, MI, USA, and followed them up for at least 90 days. Patients were included if they were aged 18 years or older, were fluent in English, owned an iPhone 6 or newer model with a supported iOS version, and had regular access to the internet throughout the study period. All participants were provided with an Apple Watch Series 3 or 4, an Omron Evolv Wireless Blood Pressure Monitor, and the MyDataHelps study smartphone application. Participants were asked to wear their watch for 12 h per day or longer and to do daily or weekly tasks, including home blood pressure measurements and breathing tasks. Heart rate, blood pressure, step counts, and distance walked were collected. The study was divided into two phases: an intensive 45-day collection phase (phase 1); and a 3-year longitudinal monitoring phase (phase 2). Here we report the first 90 days of data for all participants, which includes all of phase 1 and the first 45 days of phase 2. Participants' electronic health records were used to establish clinical diagnoses for analysis. FINDINGS: We enrolled 6765 eligible participants between Aug 14, 2018, and Dec 19, 2019, of whom 6454 participants from Michigan Medicine completed the phase 1 study protocol and were included in this analysis (3482 [54%] women and 2972 [46%] men; 3657 [57%] participants were White, with 1094 [17%] Asian and 1090 [17%] Black participants). On days when participants wore their smart watches, median daily watch wear time was 15·5 h (IQR 14-17). Participants contributed a total of 1 107 320 blood pressure and 202 198 347 heart rate measurements over 90 days, with 172 (SD 50) blood pressure and 31 329 (SD 24 620) heart rate measurements per participant. Mean systolic blood pressure was 122 mm Hg (SD 10) and mean diastolic blood pressure was 77 mm Hg (SD 8), with 167 312 (15%) measurements having a systolic blood pressure higher than 140 mm Hg or diastolic blood pressure higher than 90 mm Hg. Mean resting heart rate was 64 beats per min (SD 8). Blood pressure and resting heart rate varied by sex, age, race, and ethnicity, with higher blood pressures in males and lower heart rate in participants aged 65 years or older (p<0·0001). Participants took 7511 steps per day (SD 2805) and walked 6009 metres per day (SD 2608), varying across demographic and clinical subgroups. INTERPRETATION: These data could inform clinical trial design, interpretation of wearable data in clinical practice, and health-care interventions. FUNDING: Apple, University of Michigan.

Clinical Level of Evidence Presented at the Cervical Spine Research Society (CSRS) Annual Meeting Over 10 Years (2008-2017): A Systematic Review.

STUDY DESIGN: Systematic review. OBJECTIVE: We systematically reviewed the level of clinical evidence presented at Cervical Spine Research Society annual meetings from 2008 through 2017. SUMMARY OF BACKGROUND DATA: The Cervical Spine Research Society is dedicated to advancing knowledge of the cervical spine to promote evidence-based care. Research presented at these meetings impacts clinical practice. METHODS: A total of 774 paper abstracts presented at Cervical Spine Research Society (CSRS) annual meetings were independently assessed by two reviewers. Reviewers designated a clinical level of evidence (LOE) to each included abstract from level I to level IV based on criteria set forth by the Oxford Centre for Evidence-Based Medicine. Reviewer agreement was assessed using Cohens Kappa coefficient (k) and disagreements were discussed until a consensus was reached. Wilcoxon rank sum test was used to assess for differences in LOE grades. Chi-squared testing was used to assess nonrandom changes in level of evidence and in excluded studies. RESULTS: A total of 583 abstracts were included. Over the last 10 CSRS meetings, 5.15% of presentations were level I, 27.8% level II, 27.4% level III, and 39.6% level IV. The average LOE from 2008 to 2017 was 3.02 (median = 3). Additionally, 49.7% were therapeutic studies, 37.6% prognostic studies, and 12.7% diagnostic studies. When comparing the first 5 years (2008-2012) to the last 5 years (2013-2017), we observed a significant increase in Level II (P = 0.007) evidence and a corresponding decrease in level IV evidence (P < 0.001). The average LOE improved from 3.14 (2008-2012) to 2.91 (2013-2017); there was a significant improvement in LOE between the two periods (P = 0.001). CONCLUSION: Emphasis on evidence-based medicine within cervical spine research has positively influenced the clinical level of evidence disseminated at CSRS annual meetings between 2008 and 2017. Continued focus on higher quality Level I studies is warranted. LEVEL OF EVIDENCE: 4.

Repeated rectal application of a hyperosmolar lubricant is associated with microbiota shifts but does not affect PrEP drug concentrations: results from a randomized trial in men who have sex with men.

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is highly effective in preventing HIV infection among men who have sex with men (MSM). The effects of consistent personal lubricant use in the rectum on tissue PrEP drug concentrations and the rectal microbiota are unknown. We investigated rectal PrEP drug concentrations and the microbiota in MSM before and after repeated rectal application of a hyperosmolar lubricant. METHODS: We randomized 60 HIV-negative MSM to apply 4 mL of hyperosmolar rectal lubricant daily (n = 20), take daily oral TDF/FTC (n = 19), or both (n = 21) for seven days. Blood, rectal biopsies and rectal secretions were collected via rigid sigmoidoscopy before and on day 8 after product use. Tenofovir (TFV) and FTC as well as their intracellular metabolites tenofovir-diphosphate (TFV-DP), FTC-triphosphate (FTC-TP) were measured by HPLC-mass spectrometry. Rectal mucosal microbiota was sequenced with 16S rRNA sequencing using Illumina MiSeq. RESULTS: Seven days of lubricant application was not associated with differences in PrEP drug concentrations in rectal tissue or secretions. Lubricant use was associated with a decrease in the relative abundance of the Bacteroides genus (p = 0.01) and a non-significant increase in the Prevotella genus (p = 0.09) in the rectum. PrEP drug concentrations in rectal tissue and secretions were not associated with microbiota composition or diversity either before or after lubricant use. CONCLUSIONS: Repeated rectal application of a hyperosmolar lubricant does not affect mucosal PrEP drug concentrations but is associated with changes in the rectal microbiome.

Short Communication: Anatomic Site of Sampling and the Rectal Mucosal Microbiota in HIV Negative Men Who Have Sex with Men Engaging in Condomless Receptive Anal Intercourse.

Rectal transmission accounts for the majority of HIV transmissions among men who have sex with men (MSM). We previously demonstrated a distinct rectal mucosal immune environment in MSM engaging in condomless receptive anal intercourse (CRAI) compared with men who do not engage in anal intercourse, including enrichment of the microbiota for the Prevotellaceae family as compared with Bacteroidaceae. Here, we expand upon these previous findings to determine differences by anatomic site of collection (anal vs. rectal mucosa) and examine associations of the predominant taxa with other genera. We analyzed 16SrRNA gene sequences of the V1-V2 region generated on an Illumina MiSeq® from 35 MSM engaging in CRAI and 20 male controls. Observation by principal coordinates analysis and analysis of similarities test showed differing composition of the microbiota by anatomic site of collection. When analyzing the top 10 abundant genera from each anatomic site by generalized linear models, the predominant genera (Prevotella enrichment among MSM engaging in CRAI vs. Bacteroides among controls) were consistent; however, the two sites shared only four common genera. In addition, associations between the relative abundance of Prevotella and Bacteroides with other prevalent genera, by Spearman's rank correlations, were inconsistent when stratifying by study group. Prevotella versus Bacteroides predominant microbiota may not define a consistent underlying microbial community, and our data underline the importance of anatomic sampling site. Understanding the rectal mucosal immune environment, of which the microbiota is a critical component, will enable a better understanding of rectal HIV transmission.