Search results

The COVID-19 Citizen Science (CCS) Study was launched early in the pandemic to collect patient-reported information about exposures, risk behaviors and outcomes relevant to the pandemic. The Patient-Centered Outcomes Research Institute (PCORI) funded the research team to expand recruitment into CCS using PCORnet, the National Patient-Centered Clinical Research Network, and to use the resulting data to compare the patient-reported impact of pandemic associated policies. The research team systematically collected pandemic-associated policies enacted by counties across the United States (focusing in areas where there were many CCS participants), and to do so on a weekly basis from the beginning of the pandemic using publicly available sources.

Researchers combined data from various sources to answer two primary research questions (RQ):

1. What is the comparative impact of different shelter-in-place/reopening policies, overall and in vulnerable populations, on patient-reported financial insecurity, mental health, and other subjective outcomes important to patients?
2. What is the comparative effectiveness of county-level containment and mitigation strategies at achieving timely access to COVID-19 vaccination, testing, healthcare, information and contact tracing?

The research team collected patient-reported data from the CCS study and policy data from the U.S COVID-19 County Policy (UCCP) database. Electronic health record (EHR) data were also available from some participants recruited from health systems located across 7 U.S. states who consented and authorized use of these data for the study. Data for these participants were extracted from the PCORnet Common Data Model (CDM). Additional county-level contextual variables were included in analysis.

This collection contains CCS survey data on patient-reported anxiety with county-level policies data (DS1), respondent demographics (DS2), baseline survey results (DS3), daily (DS4) and weekly (DS5) COVID-19 symptoms reports, COVID-19 vaccination surveys repeated monthly (DS6) as well as a one-time vaccination survey (DS7), and pandemic impacts check-in surveys (DS8). CDM datasets include logistic regression model outcomes to predict study enrollment among all invited participants (DS9), codes for immunizations (DS10), laboratory tests (DS11), and procedures (DS12). County-level variables are also available for years 2021 (DS13) and 2023 (DS14).

In the United States, tobacco smoking is associated with significant morbidity and premature mortality for individuals with serious mental illness (SMI) (e.g., schizophrenia, post-traumatic stress disorder, bipolar disorder, major depressive disorder). While many smokers with SMI wish to quit smoking, few are offered advice or treatments with demonstrated effectiveness in reducing tobacco dependence, primarily medication-assisted treatments. The overall aim of this randomized controlled trial was to test the effects of provider education (PE) (i.e. provider-level educational intervention focused on evidence-based smoking cessation treatment for those with SMI) and community health worker (CHW) support on the provision and utilization of smoking cessation treatment to those with SMI, and cessation rates for adults with SMI who smoke or use tobacco over a 2-year period. The objectives of this trial were to:

1. Examine whether an intervention combining PE and CHW support would increase prescriber provision of advice and assistance to quit smoking, and improve tobacco cessation rates in smokers with SMI compared to usual care/treatment as usual (TAU) and compared to PE-only treatment
2. Determine the effect of the combined PE+CHW intervention on patient-reported overall health compared to TAU and PE-only treatment

Eligible individuals were recruited from two outpatient psychiatric service providers in the Boston, Massachusetts metropolitan area. Clinics where individuals received services were randomized into either the TAU condition or into the PE condition, where health care providers would receive additional education on first-line medications used to treat tobacco use disorder. Within clinics in the PE arm, individuals were further randomized into the community health worker (CHW) support condition (PE+CHW), where CHWs would assist participants with smoking cessation care access and provide community outreach and education, or no CHW support (PE-only). Enrolled participants (n=1,010) completed surveys on smoking/tobacco use at 3 timepoints: study baseline, 1 year post-randomization, and 2 years post-randomization.

A mixed-methods evaluation of the trial was also conducted post-intervention, using an interactive convergent design. The aims of the evaluation were to identify barriers and facilitators to effective implementation; examine how primary care providers differed by performance and engagement level, and how experiences with the intervention compared across these groups; and identify anticipated barriers to implementing the intervention as discussed by stakeholders. Quantitative outcome and visit data from the trial were used in the evaluation. For the evaluation's qualitative component, interviews were conducted with purposively sampled community health workers, smoker participants, primary care providers, and other stakeholders in policy, payor, and clinical administration. Please note that the qualitative evaluation data are not available for this collection.

Meta-analyses combine the results of many studies to find out how well a treatment or other healthcare intervention works. Most meta-analyses use public sources of data, such as published journal articles, as the main sources of information for study results. But journal articles are not the only sources of study results. Some results appear in other places, such as clinical study reports. Clinical study reports are documents that describe what researchers did and found in much more detail than journal articles. However, these reports may not be available to the public. As a result, meta-analyses may not include all available information about a treatment.

The research team wanted to learn whether adding or replacing public and nonpublic data sources changed the results of meta-analyses. To find out, the research team added and replaced data as they conducted two meta-analyses. The first looked at adult use of a nerve-pain medicine. The second meta-analysis looked at adult use of a medicine to treat bipolar depression.

Chronic low back pain is a leading cause of disability and reduced quality of life for nearly 100 million individuals in the United States. Approximately 5 to 10 percent of these individuals are prescribed opioids for treating their chronic low back pain. Limited data exists on the long-term efficacy of opioid treatment while much concern exists regarding the harm they can do to a person. Despite medication treatment patients still suffer from inadequate pain relief, impaired function, and quality of life.

This study sought to compare the long-term effectiveness of two types of alternative therapy approaches - mindfulness based therapy (MBT) and cognitive behavioral therapy (CBT) - for treating chronic low back pain especially those being treated by opioids.

This study addressed whether it is better to expand the scope of collaborative care programs to treat patients with more complex psychiatric disorders or to facilitate successful referrals to specialty mental health care. The primary objective of this study is to compare Telepsychiatry Collaborative Care (TCC) and Telepsychiatry Enhanced Referral (TER) from the patient and provider perspective. The secondary objective is to determine whether patients not engaging and responding to TER, improve with Phone-Psychiatry Enhanced Referral (PER). There are four specific aims.

Aim #1: To quantitatively compare the treatment experience, engagement, self-reported clinical outcomes, and recovery-oriented outcomes of patients initially randomized to TCC and TER.

Aim #2: For the subset of patients randomized to TER who do not engage in treatment and are still symptomatic at 6 months, quantitatively compare treatment experience, treatment engagement, self-reported clinical outcomes and recovery-oriented outcomes of patients randomized to continued-TER or PER.

Aim #3: To gain an in-depth understanding of patients' and providers' treatment experience, qualitatively compare those randomized to TCC, TER and PER.

Aim #4: To examine treatment heterogeneity among subgroups of patients randomized to TCC and TER based on race/ethnicity, age and clinical severity.