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Biostatistics and Health Services Research (BIO HSR) is a statistical science research hub and one of four divisions in the Department of Population and Quantitative Health Sciences.
We are home to the Quantitative Methods Core (QMC) that provides biostatistical support for research studies across the medical school and beyond.
We are research partners with MassHealth (Massachusetts Medicaid and CHIP), working to improve the quality of services offered. We also evaluate MassHealth programs for the Center for Medicare and Medicaid Services (CMS).
Our expertise and research projects span multiple areas, including: patient reported outcome measurement, geography-based differences in social determinants of health, international programs to reduce sexually transmitted disease, statistical methods for interpreting genetic information, and program evaluation.
This site is a repository of selected publications produced by BIO HSR faculty and researchers.
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Recent Publications
Publication Peer Academic Supports for Success: Pilot Randomised Controlled Feasibility Trial(2025-02) Davis, Maryann; Hutchinson, Dori; Cherchia, Paul; Wang, Bo; Golden, Laura; Morrison, Emily; Baczko, Amanda; Psychiatry; Population and Quantitative Health Sciences; Biostatistics and Health Services ResearchIntroduction: Mental health conditions are prevalent among university students, putting them at elevated risk for dropout. Universities offer an array of peer programmes, and students often share their concerns with peers before professionals. A well-specified peer intervention to help sustain academic persistence that colleges can directly offer their undergraduates with mental health conditions should benefit this population. The Peer Academic Supports for Success coaching model was developed to address this need. Objective: This study's goal was to conduct a feasibility and preliminary impact study of the Peer Academic Supports for Success model and feasibility of randomised controlled trial research methods. Methods: Seventy-two undergraduate students with academically impairing mental health conditions were randomised to receive Peer Academic Supports for Success versus an active control condition. Survey data were collected at baseline and at the end of the next two semesters. Official transcripts were obtained. Intervention implementation data were assessed through coach and participant report. Results: Peer Academic Supports for Success was delivered with fidelity, successfully attracted and retained students, and was safe. Randomised controlled trial methods proved feasible. Findings revealed significant treatment effects on several of the targeted proximal outcomes. Conclusions: The findings suggest Peer Academic Supports for Success is a promising university-based intervention to support young adult students with mental health conditions and should be tested in a robust clinical trial.Publication Echocardiography parameters and cardiac geometry in pregnancy by race and ethnicity(2025-01-21) Wilkie, Gianna; Essa, Angela; Person, Sharina D; Kovell, Lara; Obstetrics and Gynecology; Medicine; Population and Quantitative Health Sciences; Biostatistics and Health Services ResearchObjectives: The objective of this study was to assess transthoracic echocardiography (TTE) parameters in pregnancy by race and ethnicity. Methods: We performed a retrospective cohort study of pregnant individuals without cardiovascular disease who underwent a perinatal TTE between October 2017 and May 2022. Demographics and echocardiographic parameters were compared by race/ethnicity. Multivariate regression analysis was performed for TTE parameters after adjusting for age and hypertension. Results: During the study period, 369 individuals had TTEs with a mean age of 31.8 ± 6.0 years old. Subjects were 55.3% White, 24.7% Hispanic, 14.1% Black, and 6.0% Asian. TTE parameters of left ventricular (LV) ejection fraction and LV mass index differed by race/ethnicity, though no difference was seen in cardiac geometry. Conclusion: The differences in TTE parameters may not be clinically significant as most values fall within normal clinical ranges. Further prospective studies are needed to better evaluate cardiac outcomes by differences in echocardiographic parameters in pregnancy.Publication Neighborhood Socioeconomic Status and Breastfeeding Initiation and Duration Among Primiparous Black Women(2025-01-21) Griswold, Michele K; Crawford, Sybil L; Person, Sharina D; Rosenberg, Lynn; Palmer, Julie R; Cozier, Yvette C; Biostatistics and Health Services Research; Population and Quantitative Health Sciences; Tan Chingfen Graduate School of NursingSocial determinants of health account for racial inequities in breastfeeding rates in the United States. There is a gap in the role of neighborhood socioeconomic status (NSES) as it relates to breastfeeding disparities. Using longitudinal data from the Black Women's Health Study, we assessed associations of NSES with breastfeeding initiation and duration in a cohort of primiparous U.S. Black women. We also explored associations within strata of important economic indicators, including education, occupation, and marital status. Breastfeeding initiation ( = 2,705) increased with NSES quartile, from 75.2% in the lowest quartile to 88.3% in the highest quartile ( < 0.0001). Compared with women living in the highest NSES quartile, those in the lowest quartile had a 41% (odds ratio: 0.59 [95% confidence interval: 0.43, 0.81]) decreased odds of initiating breastfeeding. For breastfeeding duration ( = 2,172), women residing in NSES quartiles 1-3 were significantly less likely ( < 0.0001) to breastfeed (44.4%) for 6+ months compared with those living in the highest quartile (62.8%). Adjusted relative risks for those in quartiles 1-3 compared with 4 (highest) were 0.63 (0.45, 0.87), 0.50 (0.37, 0.68), and 0.64 (0.47, 0.86), respectively ( = 0.0001). There was no statistically significant evidence of effect modification by education, occupation, marital status, and region ( = >0.05). Living in a lower NSES environment was associated with reduced breastfeeding initiation and duration compared with a higher NSES environment. Research is needed to understand the mechanisms by which neighborhood-level factors influence breastfeeding initiation and duration for Black women in the United States.Publication Plasma fibronectin is a prognostic biomarker of disability in Parkinson's disease: a prospective, multicenter cohort study(2025-01-02) Zhu, Shuzhen; Li, Hualin; Huang, Zifeng; Zeng, Yiheng; Huang, Jianmin; Li, Guixia; Yang, Shujuan; Zhou, Hang; Chang, Zihan; Xie, Zhenchao; Que, Rongfang; Wei, Xiaobo; Li, Minzi; Liang, Yanran; Xian, Wenbiao; Li, Mengyan; Pan, Ying; Huang, Fanheng; Shi, Lin; Yang, Chengwu; Deng, Chao; Batzu, Lucia; Poplawska-Domaszewicz, Karolina; Chen, Shuhan; Chan, Ling-Ling; Ray Chaudhuri, K; Tan, Eng-King; Wang, Qing; Population and Quantitative Health Sciences; Biostatistics and Health Services ResearchIn a prospective longitudinal study with 218 Parkinson's disease (PD) patients in the discovery cohort and 84 in the validation cohort, we aimed to identify novel blood biomarkers predicting disability milestones in PD. Through Least Absolute Shrinkage and Selection Operator-Cox (Lasso-Cox) regression, developed nomogram predictive model and Linear mixed-effects models, we identified low level of plasma fibronectin (pFN) as one of the best-performing risk markers in predicting disability milestones. A low level of pFN was associated with a short milestone-free survival period in PD. Longitudinal analysis showed an annual decline in the rate of pFN was significantly associated with the annual elevation rate in the Hoehn-Yahr stage. Moreover, pFN level was negatively correlated with phosphorylated α-synuclein, and a low level of pFN was associated with BBB disruption in the striatum on neuroimaging, providing evidence for pFN's role in PD progression. We finally identified pFN as a novel blood biomarker that predicted first-milestone disability in PD.Publication Multiclass arrhythmia classification using multimodal smartwatch photoplethysmography signals collected in real-life settings [preprint](2024-12-13) Han, Dong; Moon, Jihye; Díaz, Luís Roberto Mercado; Chen, Darren; Williams, Devan; Mohagheghian, Fahimeh; Ghetia, Om; Peitzsch, Andrew G; Kong, Youngsun; Nishita, Nishat; Ghutadaria, Ohm; Orwig, Taylor A; Otabil, Edith Mensah; Noorishirazi, Kamran; Hamel, Alexander; Dickson, Emily L; DiMezza, Danielle; Lessard, Darleen; Wang, Ziyue; Mehawej, Jordy; Filippaios, Andreas; Naeem, Syed; Gottbrecht, Matthew F; Fitzgibbons, Timothy P; Saczynski, Jane S; Barton, Bruce; Ding, Eric Y; Tran, Khanh-Van; McManus, David D; Chon, Ki H; Medicine; Population and Quantitative Health Sciences; Biostatistics and Health Services ResearchIn the early stages of atrial fibrillation (AF), most cases are paroxysmal (pAF), making identification only possible with continuous and prolonged monitoring. With the advent of wearables, smartwatches equipped with photoplethysmographic (PPG) sensors are an ideal approach for continuous monitoring of pAF. There have been numerous studies demonstrating successful capture of pAF events, especially using deep learning. However, deep learning requires a large amount of data and independent testing on diverse datasets, to ensure the generalizability of the model, and most prior studies did not meet these requirements. Moreover, most prior studies using wearable-based PPG sensor data collection were limited either to controlled environments, to minimize motion artifacts, or to short duration data collection. Most importantly, frequent premature atrial and ventricular contractions (PAC/PVC) can confound most AF detection algorithms. This has not been well studied, largely due to limited datasets containing these rhythms. Note that the recent deep learning models show 97% AF detection accuracy, and the sensitivity of the current state-of-the-art technique for PAC/PVC detection is only 75% on minimally motion artifact corrupted PPG data. Our study aims to address the above limitations using a recently completed NIH-funded Pulsewatch clinical trial which collected smartwatch PPG data over two weeks from 106 subjects. For our approach, we used multi-modal data which included 1D PPG, accelerometer, and heart rate data. We used a computationally efficient 1D bi-directional Gated Recurrent Unit (1D-Bi-GRU) deep learning model to detect three classes: normal sinus rhythm, AF, and PAC/PVC. Our proposed 1D-Bi-GRU model's performance was compared with two other deep learning models that have reported some of the highest performance metrics, in prior work. For three-arrhythmia-classification, testing data for all deep learning models consisted of using independent data and subjects from the training data, and further evaluations were performed using two independent datasets that were not part of the training dataset. Our multimodal model achieved an unprecedented 83% sensitivity for PAC/PVC detection while maintaining a high accuracy of 97.31% for AF detection. Our model was computationally more efficient (14 times more efficient and 2.7 times faster) and outperformed the best state-of-the-art model by 20.81% for PAC/PVC sensitivity and 2.55% for AF accuracy. We also tested our models on two independent PPG datasets collected with a different smartwatch and a fingertip PPG sensor. Our three-arrhythmia-classification results show high macro-averaged area under the receiver operating characteristic curve values of 96.22%, and 94.17% for two independent datasets, demonstrating better generalizability of the proposed model.Publication Vitiligo is associated with lower body mass index: a retrospective case-control study(2024-12-09) Sharifzadeh, Afsheen; Wetstone, Rachel; Chen, Li-Chi; Guilarte-Walker, Yurima; Flahive, Julie; Harris, John E; Dermatology; Population and Quantitative Health Sciences; Biostatistics and Health Services Research.Publication Digital Health Tools and Behavioral Strategies to Increase Engagement With Diabetes Self-Management Education and Support: Design and Feasibility of DM-BOOST(2024-10-14) Amante, Daniel J; Shenette, Lisa; Wainaina, Stacey; Balakrishnan, Kavitha; Bhatia, Shina; Lee, Jung Ae; Lemon, Stephenie C; McManus, David; Harlan, David M; Malkani, Samir; Gerber, Ben S; Population and Quantitative Health Sciences; Medicine; Diabetes Center of Excellence; Biostatistics and Health Services ResearchPurpose: The purpose of the study was to describe the development and feasibility of implementing the DM-BOOST program in support of an established diabetes self-management education and support (DSMES) program. Methods: A patient panel of 4 adults with type 2 diabetes (T2DM) codesigned DM-BOOST. DM-BOOST is a patient-focused program that includes peer-written text messages about diabetes self-management behaviors and digital health training to improve patient portal use and initiate goal setting prior to a scheduled DSMES appointment. Adults with T2DM and A1C ≥8.0% participated in a 6-month feasibility pilot. Participants were randomly assigned (1:1) to receive either DM-BOOST or usual care. Outcomes included DSMES engagement (scheduled and attended DSMES appointments) and changes in diabetes self-efficacy and treatment satisfaction. Results: Pilot participants (n = 60) were 60.0% female with mean age 45.5 years (SD 8.3) and A1C 10.1% (SD 1.8%). All DM-BOOST participants (30/30, 100%) had DSMES appointments scheduled compared to 86.7% of usual care (26/30). DM-BOOST participants had fewer DSMES appointment no-shows/cancellations (3/30, 10%) compared to usual care (10/26, 35%). There was greater improvement in diabetes self-efficacy in the DM-BOOST group compared to usual care and no difference in treatment satisfaction. Conclusions: DM-BOOST, leveraging peer-written text messaging and digital health training, increased DSMES engagement. Implementation of DM-BOOST was determined to be feasible, with several system-level barriers identified, including obtaining provider referrals and scheduling appointments. An effectiveness trial of DM-BOOST is needed to evaluate the impact on clinical outcomes.Publication Repetitive transcranial magnetic stimulation alleviates motor impairment in Parkinson's disease: association with peripheral inflammatory regulatory T-cells and SYT6(2024-10-25) Xie, Fen; Shen, Bibiao; Luo, Yuqi; Zhou, Hang; Xie, Zhenchao; Zhu, Shuzhen; Wei, Xiaobo; Chang, Zihan; Zhu, Zhaohua; Ding, Changhai; Jin, Kunlin; Yang, Chengwu; Batzu, Lucia; Chaudhuri, K Ray; Chan, Ling-Ling; Tan, Eng-King; Wang, Qing; Biostatistics and Health Services Research; Population and Quantitative Health SciencesBackground: Repetitive transcranial magnetic stimulation (rTMS) has been used to treat various neurological disorders. However, the molecular mechanism underlying the therapeutic effect of rTMS on Parkinson's disease (PD) has not been fully elucidated. Neuroinflammation like regulatory T-cells (Tregs) appears to be a key modulator of disease progression in PD. If rTMS affects the peripheral Tregs in PD remains unknown. Methods: Here, we conducted a prospective clinical study (Chinese ClinicalTrials. gov: ChiCTR 2100051140) involving 54 PD patients who received 10-day rTMS (10 Hz) stimulation on the primary motor cortex (M1) region or sham treatment. Clinical and function assessment as well as flow cytology study were undertaken in 54 PD patients who were consecutively recruited from the department of neurology at Zhujiang hospital between September 2021 and January 2022. Subsequently, we implemented flow cytometry analysis to examine the Tregs population in spleen of MPTP-induced PD mice that received rTMS or sham treatment, along with quantitative proteomic approach reveal novel molecular targets for Parkinson's disease, and finally, the RNA interference method verifies the role of these new molecular targets in the treatment of PD. Results: We demonstrated that a 10-day rTMS treatment on the M1 motor cortex significantly improved motor dysfunction in PD patients. The beneficial effects persisted for up to 40 days, and were associated with an increase in peripheral Tregs. There was a positive correlation between Tregs and motor improvements in PD cases. Similarly, a 10-day rTMS treatment on the brains of MPTP-induced PD mice significantly ameliorated motor symptoms. rTMS reversed the downregulation of circulating Tregs and tyrosine hydroxylase neurons in these mice. It also increased anti-inflammatory mediators, deactivated microglia, and decreased inflammatory cytokines. These effects were blocked by administration of a Treg inhibitor anti-CD25 antibody in MPTP-induced PD mice. Quantitative proteomic analysis identified TLR4, TH, Slc6a3 and especially Syt6 as the hub node proteins related to Tregs and rTMS therapy. Lastly, we validated the role of Treg and rTMS-related protein syt6 in MPTP mice using the virus interference method. Conclusions: Our clinical and experimental studies suggest that rTMS improves motor function by modulating the function of Tregs and suppressing toxic neuroinflammation. Hub node proteins (especially Syt6) may be potential therapeutic targets. Trial registration: Chinese ClinicalTrials, ChiCTR2100051140. Registered 15 December 2021, https://www.chictr.org.cn/bin/project/edit?pid=133691.Publication Efficacy of a Multimodal Digital Behavior Change Intervention on Lifestyle Behavior, Cardiometabolic Biomarkers, and Medical Expenditure: Protocol for a Randomized Controlled Trial(2024-10-30) Howard-Wilson, Sakeina; Ching, Jack; Gentile, Sherri; Ho, Martin; Garcia, Alex; Ayturk, Didem; Lazar, Peter; Hammerquist, Nova; McManus, David; Barton, Bruce; Bird, Steven; Moore, John; Soni, Apurv; Medicine; Population and Quantitative Health Sciences; Biostatistics and Health Services ResearchBackground: The US Preventive Services Task Force recommends providers offer individualized healthy behavior interventions for all adults, independent of their risk of cardiovascular disease. While strong evidence exists to support disease-specific programs designed to improve multiple lifestyle behaviors, approaches to adapting these interventions for a broader population are not well established. Digital behavior change interventions (DBCIs) hold promise as a more generalizable and scalable approach to overcome the resource and time limitations that traditional behavioral intervention programs face, especially within an occupational setting. Objective: We aimed to evaluate the efficacy of a multimodal DBCI on (1) self-reported behaviors of physical activity, nutrition, sleep, and mindfulness; (2) cardiometabolic biomarkers; and (3) chronic disease-related medical expenditure. Methods: We conducted a 2-arm randomized controlled trial for 12 months among employees of an academic health care facility in the United States. The intervention arm received a scale, a smartphone app, an activity tracker, a video library for healthy behavior recommendations, and an on-demand health coach. The control arm received standard employer-provided health and wellness benefits. The primary outcomes of the study included changes in self-reported lifestyle behaviors, cardiometabolic biomarkers, and chronic disease-related medical expenditure. We collected health behavior data via baseline and quarterly web-based surveys, biometric measures via clinic visits at baseline and 12 months, and identified relevant costs through claims datasets. Results: A total of 603 participants were enrolled and randomized to the intervention (n=300, 49.8%) and control arms (n=303, 50.2%). The average age was 46.7 (SD 11.2) years, and the majority of participants were female (80.3%, n=484), White (85.4%, n=504), and non-Hispanic (90.7%, n=547), with no systematic differences in baseline characteristics observed between the study arms. We observed retention rates of 86.1% (n=519) for completing the final survey and 77.9% (n=490) for attending the exit visit. Conclusions: This study represents the largest and most comprehensive evaluation of DBCIs among participants who were not selected based on their underlying condition to assess its impact on behavior, cardiometabolic biomarkers, and medical expenditure. Trial registration: ClinicalTrials.gov NCT04712383; https://clinicaltrials.gov/study/NCT04712383. International registered report identifier (irrid): RR1-10.2196/50378.Publication Acupuncture in the emergency department (ACUITY): Results from a BraveNet multi-center feasibility randomized controlled trial(2024-10-21) Dusek, Jeffery A; Kallenberg, Gene A; Storrow, Alan B; Hughes, Robert M; Coyne, Christopher J; Vago, David R; Nielsen, Arya; Karasz, Alison; Kim, Ryung S; Surdam, Jessica; Segall, Tracy; Faryar, Kiran A; Dyer, Natalie L; Barton, Bruce A; McKee, M Diane; Family Medicine and Community Health; Population and Quantitative Health Sciences; Biostatistics and Health Services ResearchBackground: Pain plays a significant role in emergency department (ED) visits, however safe and effective nonpharmacologic options are needed. Prior studies of acupuncture in the ED reported pain reduction with minimal side effects, but most were small and single site. Methods: We conducted ACUITY, a prospectively designed multi-center feasibility RCT. Our goal was to recruit 165 adults with acute non-emergent pain ≥4 on a 0-10-point scale at three EDs affiliated with BraveNet Practice Based Research Network. At baseline and 45-60 min later (post), participants self-assessed their pain and anxiety using a 0-10 rating scale. The primary feasibility outcome was recruitment of participants, whereas secondary outcomes were retention, and participant/provider acceptability. Results: From May 3, 2021, to September 24, 2022, 632 eligible individuals were approached and 165 enrolled (165/632: 26.1 %), meeting our recruitment goal. Notably, 42.4 % of enrollees were Black/African American, 42.4 % were White/Caucasian, and 13.9 % were Hispanic/Latino. Participants were randomized to Acupuncture (n = 83) or Usual care (n = 82), of which 151 (91.5 %) and 128 (77.6 %) provided pain and anxiety scores at post-treatment and 1-week respectively. Acupuncture was rated acceptable to participants and providers. Mean pain ratings (pre-to-post) were 7.4 (2.2) to 4.8 (2.8) for acupuncture and 7.1 (2.3) to 6.4 (2.5) for usual care. Mean anxiety ratings (pre-to-post) were 4.5 (3.4) to 2.5 (2.6) for acupuncture and 4.1 (3.4) to 3.5 (3.2) for usual care. Conclusion: Successful completion of ACUITY indicates we have the expertise and preliminary data to conduct a future definitive, multi-center RCT. Trial registration clinical trialsgov: NCT04880733.Publication Income in Relation to Psychosocial Factors Among Stroke Survivors using Smartwatches for Atrial Fibrillation Monitoring(2024-10-11) Naeem, Syed; Jones, Tyler; Daniel, Joseph; Mehawej, Jordy; Filippaios, Andreas; Paul, Tenes; Wang, Ziyue; Howard-Wilson, Sakeina; Lessard, Darleen; Ding, Eric; Otabil, Edith Mensah; Noorishirazi, Kamran; Soni, Apurv; Saczynski, Jane; Tran, Khanh-Van; McManus, David; Medicine; Population and Quantitative Health Sciences; Biostatistics and Health Services ResearchBackground: Timely detection of atrial fibrillation (AF) is critical for stroke prevention. Smartwatches are FDA-approved devices that can now aide in this detection. Objective: Investigate how socioeconomic status is associated with self-reported psychosocial outcomes, including anxiety, patient activation, and health-related quality of life in stroke survivors using smartwatch for AF detection. Methods: We analyzed data from the Pulsewatch study, a randomized controlled trial (NCT03761394). Participants in the intervention group wore a cardiac patch monitor in addition to a smartwatch for AF detection, whereas the control group wore only the cardiac patch monitor. Generalized anxiety disorder-7 scale, Consumer Health Activation Index and short-form health survey were completed to assess anxiety, patient activation, physical and mental health status at baseline, 14, and 44 days. We used a longitudinal linear regression model to examine changes in psychosocial outcomes in low (<$50K) vs. high (>$50K) income groups. Results: A total of 95 participants (average age 64.9± 9.1 years; 57.9% male; 89.5% non-Hispanic white) were included. History of renal disease (p-value 0.029), statin use (p-value 0.034), depression (p-value 0.004), and anxiety (p-value <0.001), were different between the income groups. In the adjusted model, the low-income group was associated with increased anxiety (β 2.75, p-value 0.0003), and decreased physical health status (β -5.07, p-value 0.02). There was no change identified in self-reported patient engagement and mental health status score. Conclusion: Our findings demonstrate that low SES is associated with worse self-reporting of physical health status, and this may influence psychosocial outcomes in smartwatch users.Publication The Association between Food Insecurity and Insomnia Symptoms among Young Adults in Puerto Rico and the Mediating Role of Psychological Distress Symptoms(2024-09-28) Vázquez-Colón, Natalia; López-Cepero, Andrea; Amaya, Claudia; Tucker, Katherine L; Kiefe, Catarina I; Person, Sharina D; Rosal, Milagros C; Pérez, Cynthia M; Population and Quantitative Health Sciences; Prevention Research Center; Biostatistics and Health Services ResearchResidents of Puerto Rico face a high burden of food insecurity (FI), which has been associated with insomnia symptoms (IS). However, this association remains understudied in Puerto Rican young adults, a vulnerable group experiencing an elevated prevalence of FI and poor sleep. We evaluated the association between FI and IS and the mediating role of psychological distress symptoms among young adults in Puerto Rico. Data are derived from the PR-OUTLOOK cohort (2020-2023) of adults aged 18-29 y. We assessed FI with the six-item USDA Household Food Security Scale and IS with the 5-item Women's Health Initiative Insomnia Rating Scale. Psychological distress symptoms included depressive symptoms (CES-D-10), anxiety (STAI-10), and perceived stress (PSS-4). Poisson's regression models estimated prevalence ratios (PRs) with 95% confidence intervals (CIs). The Karlson-Holm-Breen method estimated the mediation percentage of each psychological distress symptom on the association between FI and IS. Notably, 24.8% of participants experienced FI, and 30.4% reported elevated IS. FI was associated with IS (PR = 1.41, 95% CI = 1.24, 1.60), an association partially mediated by depressive (31.6%), perceived stress (17.6%), and anxiety symptoms (17.2%), accounting for 35.8% of the mediation percentage. Future research should confirm these findings using objective assessments of sleep and psychosocial stress.Publication Association of the affordable care act with perceived health care quality of cancer survivors(2023-10-27) Oyinbo, Atinuke G; Epstein, Mara M; Sabatino, Meagan J; Liu, Shao-Hsien; Person, Sharina D; Baek, Jonggyu; Alcusky, Matthew D; Lapane, Kate L; Population and Quantitative Health Sciences; Morningside Graduate School of Biomedical Sciences; Medicine; Biostatistics and Health Services ResearchBackground: The association between the Patient Protection and Affordable Care Act (ACA) and perceptions of health care quality of cancer survivors is not well established. The purpose of this study was to examine changes in perceived health care quality concurrent with the implementation of the ACA among cancer survivors relative to a non-cancer comparison group. Methods: We used cross-sectional data from the Health Information National Trends Survey (N = 30,542). Participants were considered cancer survivors if they had a diagnosis greater than five years before the interview. The pre-ACA period included the years 2008 through 2014. The post-ACA period included 2017 through 2020. Using difference-in-differences methods, we estimated the association of ACA implementation with perceived health care quality (measured from excellent to fair/poor) using propensity score-matched cancer survivors (n = 2298) and a non-cancer comparison group (n = 6669) with weighted logistic models. Results: There were similar distributions of perceptions of excellent, very good, good, and fair/poor health care quality regardless of cancer status or time-period. The pre-post ACA implementation difference of reporting excellent, very good and good health care quality (odds ratio [OR]: 1.0, 95% confidence interval [CI]: 0.83-1.19; OR: 0.98, 95% CI 0.83-1.19; and OR: 1.05, 95% CI: 0.87-1.28 respectively) compared to fair/poor was similar in cancer survivors relative to the non-cancer comparison group. Conclusions: The initial implementation of the ACA appeared to have no effect on perceived overall health care quality reported by cancer survivors when compared to individuals without a history of cancer. Health care policies and domains which continue to support better patient-perceived care quality should be assessed in the cancer survivor population.Publication Design, creation, and use of the Test Us Bank (TUB) COVID-19 sample biorepository(2024-11-12) Broach, John; Achenbach, Chad; Behar, Stephanie; O'Connor, Laurel; Tarrant, Seanan; Ferranto, Julia; Wright, Colton; Hartin, Paul; Orwig, Taylor; Nanavati, Janvi; Kalibala, Benedict; Woods, Kelsey; Shaw, Bernadette; Flahive, Julie; Barton, Bruce; Hafer, Nathaniel; Herbert, Carly; Fahey, Nisha; Gibson, Laura; Simin, Karl; Kowalik, Timothy; Ward, Doyle V; Mirza, Agha W; Murphy, Robert L; Caputo, Matthew; Buchholz, Bryan; Fantasia, Heidi; Koren, Ainat; Marchand, Lisa; Oludare, Simisola; Sogade, Felix; Ritland, Dana; Davis, Cedrice; Grenier, Allen; Baron, Christi; Brent, Ellie; McKenney, Jennifer Bacani; Elder, Nancy; Michaels, LeAnn; Ferrara, Laura; Theron, Grant; Palmer, Zaida; Levy, Barcey; Daly, Jeanette; Parang, Kim; Schmidt, Megan; Buxton, Denis; Heetderks, William; Manabe, Yukari C; Soni, Apurv; McManus, David; Emergency Medicine; Medicine; Center for Clinical and Translational Science; Population and Quantitative Health Sciences; Pediatrics; Biostatistics and Health Services Research; Molecular, Cell, and Cancer Biology; MicrobiologyShortly after the first case of SARS-CoV-2 was diagnosed a public health emergency (PHE) was declared and a multi-agency response was initiated within the US federal government to create and propagate testing capacity. As part of this response, an unprecedented program designated Rapid Acceleration of Diagnostics (RADx) Tech was established by the National Institutes of Health (NIH) to facilitate the development of point-of-care tests for the COVID-19. The RADx Tech Clinical Studies Core (CSC), located at the University of Massachusetts Chan Medical School (UMass Chan), with partnering academic, private, and non-governmental organizations around the country, was tasked with developing clinical studies to support this work. This manuscript details development of a biorepository specifically focused on the collection and storage of samples designed for diagnostic platform development. It highlights the unified collection and annotation process that enabled gathering a diverse set of samples. This diversity encompasses the geography and backgrounds of the participants as well as sample characteristics such as variant type and RT-PCR cycle threshold (CT) value of the corresponding reference sample on a uniform clinical reference platform.Publication Medicaid Accountable Care Organizations and Disparities in Pediatric Asthma Care(2024-09-30) Geissler, Kimberley H; Shieh, Meng-Shiou; Ash, Arlene S.; Lindenauer, Peter K; Krishnan, Jerry A; Goff, Sarah L; Biostatistics and Health Services Research; Population and Quantitative Health Sciences; UMass Chan AnalyticsImportance: Nearly 6 million children in the US have asthma, and over one-third of US children are insured by Medicaid. Although 23 state Medicaid programs have experimented with accountable care organizations (ACOs), little is known about ACOs' effects on longstanding insurance-based disparities in pediatric asthma care and outcomes. Objective: To determine associations between Massachusetts Medicaid ACO implementation in March 2018 and changes in care quality and use for children with asthma. Design, setting, and participants: Using data from the Massachusetts All Payer Claims Database from January 1, 2014, to December 31, 2020, we determined child-years with asthma and used difference-in-differences (DiD) estimates to compare asthma quality of care and emergency department (ED) or hospital use for child-years with Medicaid vs private insurance for 3 year periods before and after ACO implementation for children aged 2 to 17 years. Regression models accounted for demographic and community characteristics and health status. Data analysis was conducted between January 2022 and June 2024. Exposure: Massachusetts Medicaid ACO implementation. Main outcomes and measures: Primary outcomes were binary measures in a calendar year of (1) any routine outpatient asthma visit, (2) asthma medication ratio (AMR) greater than 0.5, and (3) any ED or hospital use with asthma. To determine the statistical significance of differences in descriptive statistics between groups, χ2 and t tests were used. Results: Among 376 509 child-year observations, 268 338 (71.27%) were insured by Medicaid and 73 633 (19.56%) had persistent asthma. There was no significant change in rates of routine asthma visits for Medicaid-insured child-years vs privately insured child-years post-ACO implementation (DiD, -0.4 percentage points [pp]; 95% CI, -1.4 to 0.6 pp). There was an increase in the proportion with AMR greater than 0.5 for Medicaid-insured child-years vs privately insured in the postimplementation period (DiD, 3.7 pp; 95% CI, 2.0-5.4 pp), with absolute declines in both groups postimplementation. There was an increase in any ED or hospital use for Medicaid-insured child-years vs privately insured postimplementation (DiD, 2.1 pp; 95% CI, 1.2-3.0 pp), an 8% increase from the preperiod Medicaid use rate. Conclusions and relevance: Introduction of Massachusetts Medicaid ACOs was associated with persistent insurance-based disparities in routine asthma visit rates; a narrowing in disparities in appropriate AMR rates due to reductions in appropriate rates among those with private insurance; and worsening disparities in any ED or hospital use for Medicaid-insured children with asthma compared to children with private insurance. Continued study of changes in pediatric asthma care delivery is warranted in relation to major Medicaid financing and delivery system reforms.Publication Barriers and facilitators to home blood pressure monitoring in women with pregnancies complicated by hypertensive disorders: a qualitative study(2024-08-09) Kovell, Lara C; Denu, Mawulorm; Revoori, Ritika; Sadaniantz, Katherine; Staples, Brooke; Chiriboga, Germán; Forrester, Sarah N; Lemon, Stephenie C; Moore Simas, Tiffany A; Person, Sharina D.; McManus, David D; Mazor, Kathleen M; Biostatistics and Health Services Research; Medicine; Obstetrics and Gynecology; Pediatrics; Population and Quantitative Health Sciences; Prevention Research Center; PsychiatryBackground/objective: Hypertensive disorders of pregnancy (HDP) are a major cause of maternal morbidity and mortality in the US. Improved diagnosis and treatment of HDP may be achieved through home blood pressure monitoring (HBPM). However, there are challenges to effective HBPM during pregnancy. This qualitative study was conducted to explore patients' perspectives and experiences with HBPM. Methods: Pregnant or recently postpartum women with HDP (≥18 years) were recruited from an academic medical center to virtual focus groups from March to September 2023. The discussions centered on experiences with HDP and barriers and facilitators to HBPM. Qualitative thematic analysis was performed. Results: Among 20 participants, the mean age was 33.8 (SD 5.9) years, with 35% Hispanic and 35% Black/African-American. Facilitators to HBPM included understanding the parameters/purpose of HBPM, prior experience with healthcare/duration of hypertension, free access to HBPM equipment and decision support, creating a routine, external support/counseling (e.g., partner/healthcare/family), and technology support. Barriers to HBPM included uncertainty/lack of training about the HBPM process, accessing/using HBPM equipment, the belief that clinic monitoring was sufficient/achieving good control, and activation barriers to making HBPM a priority (e.g., fear of affirming the diagnosis, higher priorities/life stressors). Conclusion: Many of the barriers to HBPM in pregnancy can be overcome through patient education/counseling, technology support, clinician/family reinforcement, and better access to validated blood pressure monitors. Given the importance of HBPM in improving outcomes for HDP, it is important for healthcare providers and policy makers to work to reduce barriers and amplify facilitators to HBPM for better adoption.Publication Effect of multi-level social risk factors on developmental trajectories of sexual risk behaviors among Bahamian middle-to-late adolescents(2024-08-28) Kim, Deogwoon; Guo, Yan; Wang, Ava; Fahey, Nisha; Rosa, Veronica; Deveaux, Chloee; Taylor, Marcellus; Deveaux, Lynette; Biostatistics and Health Services Research; Pediatrics; Population and Quantitative Health SciencesBackground: Few studies have examined how multi-level social factors interact and affect developmental patterns of sexual risk among middle-to-late adolescents who are at risk of experiencing sexual risk behaviors. We examined developmental trajectories of sexual risk behaviors of boys and girls in middle-to-late adolescence and the effects of exposure to three social risk factors (poor parental monitoring, peer risk, and neighborhood risk). Methods: We followed 2,332 Bahamian adolescents every six months from Grades 10-12. We used group-based trajectory modeling to identify distinct trajectories of sexual risk behaviors for boys and girls. Results: We identified three trajectories each for boys and girls. Peer risk and neighborhood risk predicted a high sexual-risk trajectory for boys, and peer risk (alone or combined with other risk factors) had the greatest impact on the membership of moderate-to-high-risk trajectory for girls. Parental monitoring had a relatively small effect on adolescents' sexual risk behavior. Conclusion: Our results underscore the importance of early identification of adolescents with sexual risk behavior and development of targeted prevention interventions to improve adolescent health outcomes.Publication Effects of donor-engrafted clonal hematopoiesis in allogeneic and autologous stem cell transplantation: a systematic review and meta-analysis(2024-08-25) Xie, Yiyu; Kazakova, Vera; Weeks, Lachelle D; Gerber, Jonathan M; Tai, Jesse; Zhang, Tian Y; Lowsky, Robert; Wu, Xiaojin; Yang, Chengwu; Patel, Shyam A; Biostatistics and Health Services Research; Medicine; Population and Quantitative Health Sciences; Center for Accelerating Practices to End Suicide (CAPES)Donor stem cell health may be critically important to the success of hematopoietic stem cell transplantation (HSCT). Herein, we performed this systematic review and meta-analysis including meta-regression to assess the impact of donor-engrafted clonal hematopoiesis (CH) in allogeneic HSCT (allo-HSCT) and impact of pre-transplant CH in autologous HSCT (auto-HSCT). We applied random-effects models to analyze 5 allo-HSCT studies with 3192 donor-recipient pairs and 9 auto-HSCT studies with 2854 patients. We found that donor-engrafted CH after allo-HSCT decreased the risk of disease relapse [Hazard Ratio (HR) = 0.79, 95% Confidence Interval (CI): (0.67, 0.93)], but did not affect overall survival (OS) [HR = 0.91, 95% CI: (0.75, 1.11)], progression-free survival (PFS) [HR = 0.94, 95% CI: (0.63, 1.41)], or non-relapse mortality [HR = 1.06, 95% CI: (0.81, 1.39)]. In contrast, pre-transplant CH in auto-HSCT recipients resulted in inferior OS [HR = 1.30, 95% CI: (1.16, 1.46)], inferior PFS [HR = 1.35, 95% CI: (1.18, 1.54)], and higher risk for therapy-related myeloid neoplasm [HR = 4.85, 95% CI: (2.39, 9.82)] when compared to auto-HSCT recipients without CH. This study sheds light onto the debate about prospective "CHIP screening" for stem cell donors and addresses the impact of CH as a transmissible phenomenon.Publication Stopping use of E-cigarettes and smoking combustible cigarettes: findings from a large longitudinal digital smoking cessation intervention study in the United States(Springer Science and Business Media LLC, 2024-09-27) Lee, Donghee N; Faro, Jamie M; Stevens, Elise M; Pbert, Lori; Yang, Chengwu; Sadasivam, Rajani S; Biostatistics and Health Services Research; Obstetrics and Gynecology; Population and Quantitative Health Sciences; Prevention Research CenterObjective: Digital interventions have been widely implemented to promote tobacco cessation. However, implementations of these interventions have not yet considered how participants' e-cigarette use may influence their quitting outcomes. We explored the association of e-cigarette use and quitting smoking within the context of a study testing a digital tobacco cessation intervention among individuals in the United States who were 18 years and older, smoked combustible cigarettes, and enrolled in the intervention between August 2017 and March 2019. Results: We identified four e-cigarette user groups (n = 990) based on the participants' baseline and six-month e-cigarette use (non-users, n = 621; recently started users, n = 60; sustained users, n = 187; recently stopped users, n = 122). A multiple logistic regression was used to estimate the adjusted odds ratios (AOR) of six-month quit outcome and the e-cigarette user groups. Compared to e-cigarette non-users, the odds of quitting smoking were significantly higher among recently stopped users (AOR = 1.68, 95% CI [1.06, 2.67], p = 0.03). Participants who were most successful at quitting combustible cigarettes also stopped using e-cigarettes at follow-up, although many sustained using both products. Findings suggest that digital tobacco cessation interventions may carefully consider how to promote e-cigarette use cessation among participants who successfully quit smoking. Trial registration: ClinicalTrials.gov identifier NCT03224520 (July 21, 2017).Publication Implementation strategies for decentralized management of multidrug-resistant tuberculosis: insights from community health systems in Zambia(2024-09-14) Zulu, Joseph Mumba; Maritim, Patricia; Halwiindi, Hikabasa; Chavula, Malizgani Paul; Munakampe, Margarate; Matenga, Tulani Francis L; Mweemba, Chris; Sinyangwe, Ntazana N; Habib, Batuli; Musukuma, Mwiche; Silumbwe, Adam; Wang, Bo; Kaonga, Patrick; Chewe, Mwimba; Fisa, Ronald; Banda, Jeremiah; Mubanga, Angel; Phiri, Henry; Biostatistics and Health Services Research; Population and Quantitative Health SciencesBackground: Decentralized management approaches for multi-drug-resistant tuberculosis (MDR TB) have shown improved treatment outcomes in patients. However, challenges remain in the delivery of decentralized MDR TB services. Further, implementation strategies for effectively delivering the services in community health systems (CHSs) in low-resource settings have not been fully described, as most strategies are known and effective in high-income settings. Our research aimed to delineate the specific implementation strategies employed in managing MDR TB in Zambia. Methods: Our qualitative case study involved 112 in-depth interviews with a diverse group of participants, including healthcare workers, community health workers, patients, caregivers, and health managers in nine districts. We categorized implementation strategies using the Expert Recommendations for Implementing Change (ERIC) compilation and later grouped them into three CHS lenses: programmatic, relational, and collective action. Results: The programmatic lens comprised four implementation strategies: (1) changing infrastructure through refurbishing and expanding health facilities to accommodate management of MDR TB, (2) adapting and tailoring clinical and diagnostic services to the context through implementing tailored strategies, (3) training and educating health providers through ongoing training, and (4) using evaluative and iterative strategies to review program performance, which involved development and organization of quality monitoring systems, as well as audits. Relational lens strategies were (1) providing interactive assistance through offering local technical assistance in clinical expert committees and (2) providing support to clinicians through developing health worker and community health worker outreach teams. Finally, the main collective action lens strategy was engaging consumers; the discrete strategies were increasing demand using community networks and events and involving patients and family members. Conclusion: This study builds on the ERIC implementation strategies by stressing the need to fully consider interrelations or embeddedness of CHS strategies during implementation processes. For example, to work effectively, the programmatic lens strategies need to be supported by strategies that promote meaningful community engagement (the relational lens) and should be attuned to strategies that promote community mobilization (collective action lens).