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1.
PLoS One ; 19(3): e0286371, 2024.
Article in English | MEDLINE | ID: mdl-38457409

ABSTRACT

BACKGROUND: Most patients with COVID-19 report experiencing one or more symptoms after acute infection subsides, known as post-acute sequelae of SARS-CoV-2 infection (PASC). Though research has examined PASC after acute COVID-19, few studies have examined PASC over a longer follow-up duration or accounted for rates of symptoms and diagnoses before COVID-19 infection, and included those not actively seeking treatment for PASC. To determine what symptoms and diagnoses are occurring at higher rates after acute COVID-19 infection from a more inclusive sample, we extracted electronic hospital records (EHR) data from 13,033 adults with previously known diagnoses and symptoms. METHODS: The sample was comprised of patients who had a positive PCR test for SARS-CoV-2 between March 1, 2020, and December 31, 2020, and follow-up was conducted through November 29, 2021. All patients in the sample had medical appointments ≥4 weeks before and ≥4 weeks after their positive PCR test. At these appointments, all ICD-10 codes recorded in the EHR were classified into 21 categories based on the literature and expert review. Conditional logistic regression models were used to quantify the odds of these symptoms and diagnostic categories following COVID-19 infection relative to visits occurring before infection. The sample was comprised of 28.0% adults over 65 and was 57.0% female. After the positive PCR test, the most recorded diagnoses and symptoms were dyspnea and respiratory failure, myositis, musculoskeletal pain/stiffness, anxiety, and depression. RESULTS: Results from regression analyses showed increased odds of diagnosis for 15 of the 21 categories following positive PCR. Relative to pre-COVID, the diagnoses and symptoms with the greatest odds after a positive PCR test were loss of smell or taste [OR (95% CI) = 6.20 (3.18-12.09)], pulmonary fibrosis [3.50 (1.59-7.68)], and dyspnea/respiratory failure [2.14 (1.92-2.40)]. Stratification of these analyses by age, gender, race, and ethnicity showed similar results. CONCLUSION: The increased symptoms and diagnoses detected in the current study match prior analyses of PASC diagnosis and treatment-seeking patients. The current research expands upon the literature by showing that these symptoms are more frequently detected following acute COVID-19 than before COVID-19. Further, our analyses provide a broad snapshot of the population as we were able to describe PASC among all patients who tested positive for COVID-19.


Subject(s)
COVID-19 , Respiratory Insufficiency , Adult , Humans , Female , Male , COVID-19/diagnosis , SARS-CoV-2 , Post-Acute COVID-19 Syndrome , Dyspnea
3.
Sensors (Basel) ; 24(3)2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38339663

ABSTRACT

Accelerometers have been used to objectively quantify physical activity, but they can pose a high burden. This study was conducted to determine the feasibility of using a single-item smartphone-based ecological momentary assessment (EMA) in lieu of accelerometers in long-term assessment of daily exercise. Data were collected from a randomized controlled trial of intermittently exercising, otherwise healthy adults (N = 79; 57% female, mean age: 31.9 ± 9.5 years) over 365 days. Smartphone-based EMA self-reports of exercise entailed daily end-of-day responses about physical activity; the participants also wore a Fitbit device to measure physical activity. The Kappa statistic was used to quantify the agreement between accelerometer-determined (24 min of moderate-to-vigorous physical activity [MVPA] within 30 min) and self-reported exercise. Possible demographic predictors of agreement were assessed. Participants provided an average of 164 ± 87 days of complete data. The average within-person Kappa was κ = 0.30 ± 0.22 (range: -0.15-0.73). Mean Kappa ranged from 0.16 to 0.30 when the accelerometer-based definition of an exercise bout varied in duration from 15 to 30 min of MVPA within any 30 min period. Among the correlates examined, sex was significantly associated with agreement; mean agreement was higher among women (κ = 0.37) than men (κ = 0.20). Agreement between EMA self-reported and accelerometer-measured exercise was fair, suggesting that long-term exercise monitoring through a single-item EMA may be acceptable.


Subject(s)
Accelerometry , Ecological Momentary Assessment , Male , Adult , Humans , Female , Young Adult , Exercise/physiology , Self Report , Smartphone
4.
JACC Adv ; 3(1)2024 Jan.
Article in English | MEDLINE | ID: mdl-38375059

ABSTRACT

Precision prevention embraces personalized prevention but includes broader factors such as social determinants of health to improve cardiovascular health. The quality, quantity, precision, and diversity of data relatable to individuals and communities continue to expand. New analytical methods can be applied to these data to create tools to attribute risk, which may allow a better understanding of cardiovascular health disparities. Interventions using these analytic tools should be evaluated to establish feasibility and efficacy for addressing cardiovascular disease disparities in diverse individuals and communities. Training in these approaches is important to create the next generation of scientists and practitioners in precision prevention. This state-of-the-art review is based on a workshop convened to identify current gaps in knowledge and methods used in precision prevention intervention research, discuss opportunities to expand trials of implementation science to close the health equity gaps, and expand the education and training of a diverse precision prevention workforce.

5.
Obstet Gynecol ; 143(3): e78-e85, 2024 Mar 01.
Article in English | MEDLINE | ID: mdl-38128099

ABSTRACT

The National Institutes of Health's (NIH) Pathways to Prevention panel on postpartum health provides a consensus statement on the evidence, research gaps, and future priorities to prevent maternal morbidity and mortality. The panel reviewed an NIH-commissioned evidence review and workshop that included epidemiologic studies, demonstration interventions, and other maternal morbidity and mortality research to create these national recommendations. The panel concludes that a maternal morbidity and mortality crisis reflects a systemic failure of current U.S. health care, research efforts, and social policies. The panel recommends improving maternal health through a "maternal morbidity and mortality prevention moonshot" that adopts a comprehensive, multilevel life course conceptual framework; strengthens the research methods used within the science of maternal health; establishes and conducts national prevention, treatment, and policy interventions; and reimburses evidence-informed clinical approaches to improve maternal health across the life course. Without a national focus on fundamentally transformative interventions and other initiatives aimed at redressing structural racism and inequities in health care, current interventions and clinical advances in maternal morbidity and mortality prevention will remain tragically insufficient.


Subject(s)
Maternal Mortality , National Institutes of Health (U.S.) , Female , United States/epidemiology , Humans , Consensus , Evidence-Based Medicine , Maternal Health
6.
Int J Med Inform ; 181: 105286, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37956643

ABSTRACT

BACKGROUND: COVID-19 is a challenging disease to characterize given its wide-ranging heterogeneous symptomatology. Several studies have attempted to extract clinical phenotypes but often relied on data from small patient cohorts, usually limited to only one viral variant and utilizing a static snapshot of patient data. OBJECTIVE: This study aimed to identify clinical phenotypes of hospitalized COVID-19 patients and investigate their longitudinal dynamics throughout the pandemic, with the goal to relate these phenotypes to clinical outcomes and treatment strategies. METHODS: We utilized routinely collected demographic and clinical data throughout the hospitalization of 38,077 patients admitted between 3/2020 to 5/2022, in 12 New York hospitals. Uniform Manifold Approximation and Projection and agglomerative hierarchical clustering were used to derive the clusters, followed by exploratory data analysis to compare the prevalence of comorbidities and treatments per cluster. RESULTS: 4 distinct clinical phenotypes remained robust in multi-site validation and were associated with different mortality rates. The temporal progression of these phenotypes throughout the COVID-19 pandemic demonstrated increased variability across the waves of the three dominant viral variants (alpha, delta, omicron). Longitudinal analysis evaluating changes in clinical phenotypes of each patient throughout the course of a 4-week hospital stay exemplified the dynamic nature of the disease progression. Factors such as sex, race/ethnicity and specific treatment modalities revealed significant and clinically relevant differences between the observed phenotypes. CONCLUSIONS: Our proposed methodology has the potential of enabling clinicians and policy makers to draw evidence-based conclusions for guiding treatment modalities in a dynamic fashion.


Subject(s)
COVID-19 , Pandemics , Humans , New York/epidemiology , COVID-19/epidemiology , Hospitals , Phenotype
7.
Front Psychol ; 14: 1233884, 2023.
Article in English | MEDLINE | ID: mdl-37794909

ABSTRACT

Stress is a significant public health burden in the United States, with most Americans reporting unhealthy levels of stress. Stress management techniques include various evidence-based treatments shown to be effective but with heterogeneous treatment responses, indicating a lack of uniform benefits for all individuals. Designed to assess a participant's response to a specific intervention, personalized (N-of-1) trials provide guidance for which treatment (s) work (s) best for the individual. Prior studies examining the effects of mindfulness meditation, yoga, and walking for stress reduction found all three interventions to be associated with significant reductions in self-reported measures of stress. Delivering these treatments using a personalized trial approach has the potential to assist clinicians in identifying the best stress management techniques for individuals with persistently high stress while fostering treatment decisions that consider their personal condition/barriers. This trial will evaluate a personalized approach compared to standard of care for three interventions (guided mindfulness meditation; guided yoga; and guided brisk walking) to manage perceived stress. Participants will respond to daily surveys and wear a Fitbit device for 18 weeks. After a 2-week baseline period, participants in the personalized trial groups will receive 12 weeks of interventions in randomized order, while participants in the standard-of-care group will have access to all interventions for self-directed stress management. After intervention, all participants will undergo 2 weeks of observation, followed by two additional weeks of the stress management intervention of their choosing while continuing outcome measurement. At study completion, all participants will be sent a satisfaction survey. The primary analysis will compare perceived stress levels between the personalized and standard of care arms. The results of this trial will provide further support for the use of personalized designs for managing stress. Clinical Trial Registration: clinicaltrials.gov, NCT05408832. Protocol version: 9/14/2022, 21-0968-MRB.

8.
JMIR Form Res ; 7: e45510, 2023 Sep 18.
Article in English | MEDLINE | ID: mdl-37721795

ABSTRACT

BACKGROUND: Fatigue is one of the most common symptoms treated in primary care and can lead to deficits in mental health and functioning. Light therapy can be an effective treatment for symptoms of fatigue; however, the feasibility, scalability, and individual-level heterogeneity of light therapy for fatigue are unknown. OBJECTIVE: This study aimed to evaluate the feasibility, acceptability, and effectiveness of a series of personalized (N-of-1) interventions for the virtual delivery of bright light (BL) therapy and dim light (DL) therapy versus usual care (UC) treatment for fatigue in 60 participants. METHODS: Participants completed satisfaction surveys comprising the System Usability Scale (SUS) and items assessing satisfaction with the components of the personalized trial. Symptoms of fatigue were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) daily, PROMIS weekly, and ecological momentary assessment (EMA) questionnaires delivered 3 times daily. Comparisons of fatigue between the BL, DL, and UC treatment periods were conducted using generalized linear mixed model analyses between participants and generalized least squares analyses within individual participants. RESULTS: Participants rated the usability of the personalized trial as acceptable (average SUS score=78.9, SD 15.6), and 92% (49/53) of those who completed satisfaction surveys stated that they would recommend the trial to others. The levels of fatigue symptoms measured using the PROMIS daily fatigue measure were lower or improved in the BL (B=-1.63, 95% CI -2.63 to -0.63) and DL (B=-1.44, 95% CI -2.50 to -0.38) periods relative to UC. The treatment effects of BL and DL on the PROMIS daily measure varied among participants. Similar findings were demonstrated for the PROMIS weekly and EMA measures of fatigue symptoms. CONCLUSIONS: The participant scores on the SUS and satisfaction surveys suggest that personalized N-of-1 trials of light therapy for fatigue symptoms are both feasible and acceptable. Both interventions produced significant (P<.05) reductions in participant-reported PROMIS and EMA fatigue symptoms relative to UC. However, the heterogeneity of these treatment effects across participants indicated that the effect of light therapy was not uniform. This heterogeneity along with high ratings of usability and satisfaction support the use of personalized N-of-1 research designs in evaluating the effect of light therapy on fatigue for each patient. Furthermore, the results of this trial provide additional support for the use of a series of personalized N-of-1 research trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT04707846; https://clinicaltrials.gov/ct2/show/NCT04707846.

9.
JMIR Res Protoc ; 12: e45313, 2023 Aug 03.
Article in English | MEDLINE | ID: mdl-37535419

ABSTRACT

BACKGROUND: Poor sleep, defined as short-duration or poor-quality sleep, is a frequently reported condition with many deleterious effects including poorer cognitive functioning, increased accidents, and poorer health. Melatonin has been shown to be an efficacious treatment to manage symptoms of poor sleep. However, the treatment effects of melatonin on sleep can vary greatly between participants. Personalized, or N-of-1, trial designs represent a method for identifying the best treatment for individual participants. Although using N-of-1 trials of melatonin to treat poor sleep is possible, the feasibility, acceptability, and effectiveness of N-of-1 trials using melatonin are unknown. Using the National Institutes of Health Stage Model for Behavioral Intervention Development, a stage IB (intervention refinement, modification, and adaptation and pilot testing) design appeared to be needed to address these feasibility questions. OBJECTIVE: This trial series evaluates the feasibility, acceptability, and effectiveness of a series of personalized interventions for remote delivery of melatonin dose (3 and 0.5 mg) versus placebo supplements for self-reported poor sleep among 60 participants. The goal of this study is to provide valuable information about implementing remote N-of-1 randomized controlled trials to improve poor sleep. METHODS: Participants will complete a 2-week baseline followed by six 2-week alternating intervention periods of 3 mg of melatonin, 0.5 mg of melatonin, and placebo. Participants will be randomly assigned to 2 intervention orders. The feasibility and acceptability of the personalized trial approach will be determined with participants' ratings of usability and satisfaction with the remote, personalized intervention delivery system. The effectiveness of the intervention will be measured using participants' self-reported sleep quality and duration and Fitbit tracker-measured sleep duration and efficiency. Additional measures will include ecological momentary assessment measures of fatigue, stress, pain, mood, concentration, and confidence as well as measures of participant adherence to the intervention, use of the Fitbit tracker, and survey data collection. RESULTS: As of the submission of this protocol, recruitment for this National Institutes of Health stage IB personalized trial series is approximately 78.3% complete (47/60). We expect recruitment and data collection to be finalized by June 2023. CONCLUSIONS: Evaluating the feasibility, acceptability, and effectiveness of a series of personalized interventions of melatonin will address the longer term aim of this program of research-is integrating N-of-1 trials useful patient care? The personalized trial series results will be published in a peer-reviewed journal and will follow the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015) reporting guidelines. This trial series was approved by the Northwell Health institutional review board. TRIAL REGISTRATION: ClinicalTrials.gov NCT05349188; https://www.clinicaltrials.gov/study/NCT05349188. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45313.

10.
Trials ; 24(1): 523, 2023 Aug 12.
Article in English | MEDLINE | ID: mdl-37573428

ABSTRACT

BACKGROUND: In the USA, the primary cause of death and morbidity continues to be cardiovascular disease (CVD). Numerous trials have shown that statin medication reduces the likelihood of CVD events; it is a cornerstone of CVD prevention. However, studies have also indicated that up to 60% of the estimated 26.8 million Americans prescribed primary prevention statin treatment are nonadherent during the first year. Multi-component behavioral change technique (BCT) therapies have shown moderate promise in improving medication adherence as well as other positive health behaviors (such as physical activity). However, no research has looked at the duration of multi-component BCT intervention needed to result in a clinically significant improvement in statin adherence behaviors. This study aims to determine the necessary dose of a multi-component BCT intervention (defined as duration in weeks) to promote adherence to statin medication among those on primary prevention statin treatment by utilizing the modified time-to-event continuous reassessment method (TiTE-CRM). METHODS AND DESIGN: The study will utilize the modified TiTE-CRM in 42 participants, recruited in 14 cohorts of 3 participants each. The goal of this analysis is to identify the minimum effective dose (MED) of a multi-behavior change technique (BCT) intervention required to increase adherence to statins by 20% between baseline and follow-up periods. Using the TiTE-CRM method, the dose of the behavior intervention in weeks will be assigned to each cohort based on the performance of the prior cohort. At the end of the study, the intervention dose that has been found to be associated with a 20% increase in statin adherence among 80% of participants assigned to that dose will be identified as the MED. DISCUSSION: If successful, the current trial will provide additional guidance to researchers and clinicians seeking to increase statin medication adherence using a BCT intervention by identifying the dose (i.e., the duration) of an intervention required to meaningfully increase adherence. TRIAL REGISTRATION: ClinicalTrials.gov NCT05273736. Registered on March 10, 2022. https://www. CLINICALTRIALS: gov/ct2/show/NCT05273736.


Subject(s)
Cardiovascular Diseases , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Humans , Behavior Therapy , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/drug therapy , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Medication Adherence , Primary Prevention/methods
11.
JMIR Res Protoc ; 12: e43418, 2023 Jun 14.
Article in English | MEDLINE | ID: mdl-37314839

ABSTRACT

BACKGROUND: Being physically active is critical to successful aging, but most middle-aged and older adults do not move enough. Research has shown that even small increases in activity can have a significant impact on risk reduction and improve quality of life. Some behavior change techniques (BCTs) can increase activity, but prior studies on their effectiveness have primarily tested them in between-subjects trials and in aggregate. These design approaches, while robust, fail to identify those BCTs most influential for a given individual. In contrast, a personalized, or N-of-1, trial design can assess a person's response to each specific intervention. OBJECTIVE: This study is designed to test the feasibility, acceptability, and preliminary effectiveness of a remotely delivered personalized behavioral intervention to increase low-intensity physical activity (ie, walking) in adults aged 45 to 75 years. METHODS: The intervention will be administered over 10 weeks, starting with a 2-week baseline period followed by 4 BCTs (goal-setting, self-monitoring, feedback, and action planning) delivered one at a time, each for 2 weeks. In total, 60 participants will be randomized post baseline to 1 of 24 intervention sequences. Physical activity will be continuously measured by a wearable activity tracker, and intervention components and outcome measures will be delivered and collected by email, SMS text messages, and surveys. The effect of the overall intervention on step counts relative to baseline will be examined using generalized linear mixed models with an autoregressive model that accounts for possible autocorrelation and linear trends for daily steps across time. Participant satisfaction with the study components and attitudes and opinions toward personalized trials will be measured at the intervention's conclusion. RESULTS: Pooled change in daily step count will be reported between baseline and individual BCTs and baseline versus overall intervention. Self-efficacy scores will be compared between baseline and individual BCTs and between baseline and the overall intervention. Mean and SD will be reported for survey measures (participant satisfaction with study components and attitudes and opinions toward personalized trials). CONCLUSIONS: Assessing the feasibility and acceptability of delivering a personalized, remote physical activity intervention for middle-aged and older adults will inform what steps will be needed to scale up to a fully powered and within-subjects experimental design remotely. Examining the effect of each BCT in isolation will allow for their unique impact to be assessed and support design of future behavioral interventions. In using a personalized trial design, the heterogeneity of individual responses for each BCT can be quantified and inform later National Institutes of Health stages of intervention development trials. TRIAL REGISTRATION: clinicaltrials.gov NCT04967313; https://clinicaltrials.gov/ct2/show/NCT04967313. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/43418.

12.
Contemp Clin Trials Commun ; 33: 101135, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37333978

ABSTRACT

Background: Personalized interventions that can be delivered remotely are needed to increase physical activity (PA) in older adults to reduce risk of CV disease and mortality. Prior research indicates that Behavioral Change Techniques (BCTs) (e.g., goal setting, self-monitoring, behavioral repetition) can instill a habit for increasing daily walking. However, past interventions relied on between-subject randomized clinical trials, which can only only be informative about response of the hypothetical average person. Personalized trial designs can identify the benefits of an intervention for a specific individual although extended periods are required for collecting frequent measurements within-subject. Advances in remote, virtual technologies (e.g., text messaging, activity trackers), integrated with automatic platforms, can meet these requirements because they capacitate delivery of BCT interventions, and collection of data during daily life without personal contact. This Stage I-b trial is designed test whether a virtual, personalized intervention is feasible and acceptable to older adults, can elicit participant adherence and exhibit preliminary evidence for efficacy. Methods: A series of up to 60 single-arm, personalized trials, involving no personal contact, will recruit adults, 45-75 years of age, to wear an activity tracker during a 2-week baseline and a 10-week intervention. Five BCT prompts to execute a walking plan will be delivered on a daily basis during the intervention phase. Participants will rate satisfaction with personalized trial components and whether automaticity of the walking plan can be achieved. Step-counts, adherence to the walking plan and self-monitoring of step-count will also be recorded.

13.
JAMA ; 329(24): 2163-2170, 2023 06 27.
Article in English | MEDLINE | ID: mdl-37338866

ABSTRACT

Importance: Anxiety disorders are commonly occurring mental health conditions. They are often unrecognized in primary care settings and substantial delays in treatment initiation occur. Objective: The US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of screening for anxiety disorders in asymptomatic adults. Population: Asymptomatic adults 19 years or older, including pregnant and postpartum persons. Older adults are defined as those 65 years or older. Evidence Assessment: The USPSTF concludes with moderate certainty that screening for anxiety disorders in adults, including pregnant and postpartum persons, has a moderate net benefit. The USPSTF concludes that the evidence is insufficient on screening for anxiety disorders in older adults. Recommendation: The USPSTF recommends screening for anxiety disorders in adults, including pregnant and postpartum persons. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for anxiety disorders in older adults. (I statement).


Subject(s)
Anxiety , Mass Screening , Female , Pregnancy , Humans , Aged , Mass Screening/adverse effects , Anxiety Disorders/diagnosis , Anxiety Disorders/therapy , Preventive Health Services , Fear
14.
JAMA ; 329(23): 2057-2067, 2023 06 20.
Article in English | MEDLINE | ID: mdl-37338872

ABSTRACT

Importance: Major depressive disorder (MDD), a common mental disorder in the US, may have substantial impact on the lives of affected individuals. If left untreated, MDD can interfere with daily functioning and can also be associated with an increased risk of cardiovascular events, exacerbation of comorbid conditions, or increased mortality. Objective: The US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate benefits and harms of screening, accuracy of screening, and benefits and harms of treatment of MDD and suicide risk in asymptomatic adults that would be applicable to primary care settings. Population: Asymptomatic adults 19 years or older, including pregnant and postpartum persons. Older adults are defined as those 65 years or older. Evidence Assessment: The USPSTF concludes with moderate certainty that screening for MDD in adults, including pregnant and postpartum persons and older adults, has a moderate net benefit. The USPSTF concludes that the evidence is insufficient on the benefit and harms of screening for suicide risk in adults, including pregnant and postpartum persons and older adults. Recommendation: The USPSTF recommends screening for depression in the adult population, including pregnant and postpartum persons and older adults. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for suicide risk in the adult population, including pregnant and postpartum persons and older adults. (I statement).


Subject(s)
Depressive Disorder, Major , Mass Screening , Suicide , Adult , Aged , Female , Humans , Male , Pregnancy , Depression/diagnosis , Depressive Disorder, Major/complications , Depressive Disorder, Major/diagnosis , Mass Screening/adverse effects , Mass Screening/methods , Risk Assessment , United States
17.
Health Psychol ; 42(5): 285-286, 2023 May.
Article in English | MEDLINE | ID: mdl-37011156

ABSTRACT

The BMRC has initiated a new initiative, the Behavioral Medicine Research Council (BMRC) Scientific Statement papers. The statement papers will move the field forward by guiding efforts to improve the quality of behavioral medicine research and practice and facilitate the dissemination and translation of behavioral medicine research. (PsycInfo Database Record (c) 2023 APA, all rights reserved).


Subject(s)
Behavioral Medicine , Humans , Consensus , Behavioral Research
18.
Contemp Clin Trials ; 130: 107205, 2023 07.
Article in English | MEDLINE | ID: mdl-37105318

ABSTRACT

BACKGROUND: Statin therapy is a mainstay of cardiovascular disease (CVD) prevention, but research shows that statin therapy alone is insufficient for preventing incident CVD and mortality. Combining statin medication with increased physical activity (PA) can lower mortality risk more than either statin or PA alone. However, PA levels often remain the same and may even decline following statin prescription. Additional information is needed to identify how to increase PA among statin users and determine the minimal length of an intervention (i.e., intervention dose) necessary to increase PA. OBJECTIVE: The study aims to identify the required dose of a behavior change technique (BCT) intervention to increase PA among individuals on primary prevention statin therapy who have an elevated risk for cardiovascular disease (CVD). METHODS: The study will utilize the modified time-to-event continual reassessment method (TiTE-CRM) in 42 participants. We expect insights relating to dose-efficacy models and BCTs (Behavior Change Techniques) to improve PA in adults at risk for CVD. This trial will also examine potential mechanisms of action (MoAs) for interventions to increase PA, identify any effect a PA intervention may have on medication adherence, and determine whether participants respond uniformly to their respective behavioral interventions. ETHICS AND DISSEMINATION: This trial was approved by the Northwell Health Institutional Review Board (IRB) and all participants will complete informed consent. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalized trials will follow the CONSORT reporting guidelines. REGISTRATION DETAILS: This trial is registered on www. CLINICALTRIALS: gov (Number NCT05273723).


Subject(s)
Cardiovascular Diseases , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Adult , Humans , Behavior Therapy , Cardiovascular Diseases/prevention & control , Exercise , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Primary Prevention/methods
19.
Ann Fam Med ; 21(2): 165-171, 2023.
Article in English | MEDLINE | ID: mdl-36973047

ABSTRACT

PURPOSE: The US Preventive Services Task Force (USPSTF) is an independent body that makes evidence-based recommendations regarding preventive services to improve health for people nationwide. Here, we summarize current USPSTF methods, describe how methods are evolving to address preventive health equity, and define evidence gaps for future research. METHODS: We summarize current USPSTF methods as well as ongoing methods development. RESULTS: The USPSTF prioritizes topics on the basis of disease burden, extent of new evidence, and whether the service can be provided in primary care and going forward will increasingly consider health equity. Analytic frameworks specify the key questions and linkages connecting the preventive service to health outcomes. Contextual questions provide information on natural history, current practice, health outcomes in high-risk groups, and health equity. The USPSTF assigns a level of certainty to the estimate of net benefit of a preventive service (high, moderate, or low). The magnitude of net benefit is also judged (substantial, moderate, small, or zero/negative). The USPSTF uses these assessments to assign a letter grade from A (recommend) to D (recommend against). I statements are issued when evidence is insufficient. CONCLUSIONS: The USPSTF will continue to evolve its methods for simulation modeling and to use evidence to address conditions for which there are limited data for population groups who bear a disproportionate burden of disease. Additional pilot work is underway to better understand the relations of the social constructs of race, ethnicity, and gender with health outcomes to inform the development of a USPSTF health equity framework.


Subject(s)
Evidence-Based Medicine , Health Equity , Humans , United States , Advisory Committees , Preventive Health Services , Forecasting
20.
Geroscience ; 45(1): 569-589, 2023 02.
Article in English | MEDLINE | ID: mdl-36242693

ABSTRACT

Exercise is a cornerstone of preventive medicine and a promising strategy to intervene on the biology of aging. Variation in the response to exercise is a widely accepted concept that dates back to the 1980s with classic genetic studies identifying sequence variations as modifiers of the VO2max response to training. Since that time, the literature of exercise response variance has been populated with retrospective analyses of existing datasets that are limited by a lack of statistical power from technical error of the measurements and small sample sizes, as well as diffuse outcomes, very few of which have included older adults. Prospective studies that are appropriately designed to interrogate exercise response variation in key outcomes identified a priori and inclusive of individuals over the age of 70 are long overdue. Understanding the underlying intrinsic (e.g., genetics and epigenetics) and extrinsic (e.g., medication use, diet, chronic disease) factors that determine robust versus poor responses to various exercise factors will be used to improve exercise prescription to target the pillars of aging and optimize the clinical efficacy of exercise training in older adults. This review summarizes the proceedings of the NIA-sponsored workshop entitled, "Understanding Heterogeneity of Responses to, and Optimizing Clinical Efficacy of, Exercise Training in Older Adults" and highlights the importance and current state of exercise response variation research, particularly in older adults, prevailing challenges, and future directions.


Subject(s)
Exercise Therapy , Exercise , Humans , Aged , Prospective Studies , Retrospective Studies , Exercise/physiology , Treatment Outcome
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