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).

The purpose of this study was to expand the research capacity for comparative effectiveness evaluations of patients with multiple chronic conditions. Researchers administered a generic Quality of Life (QOL) instrument, physical symptom assessment, patient health questionnaire, and a tobacco screen through audio computer-assisted self-interviews (ACASI) and linked the responses to their electronic medical records (EMR) data. Researchers also calculated two co-morbidity indices (Chronic Disease Score and Charlson Co-morbidity Index).

The Epidemiologic Catchment Area (ECA) program of research was initiated in response to the 1977 report of the President's Commission on Mental Health. The purpose was to collect data on the prevalence and incidence of mental disorders and on the use of and need for services by the mentally ill. Independent research teams at five universities (Yale University, Johns Hopkins University, Washington University, Duke University, and University of California at Los Angeles), in collaboration with the National Institute for Mental Health, conducted the studies with a core of common questions and sample characteristics. The sites were areas that had previously been designated as Community Mental Health Center catchment areas: New Haven, Connecticut, Baltimore, Maryland, St. Louis, Missouri, Durham, North Carolina, and Los Angeles, California. Each site sampled over 3,000 community residents and 500 residents of institutions, yielding 20,861 respondents overall. The longitudinal ECA design incorporated two waves of personal interviews administered one year apart and a brief telephone interview in between (for the household sample). The diagnostic interview used in the ECA was the NIMH Diagnostic Interview Schedule (DIS), Version III (with the exception of the Yale Wave I survey, which used Version II). Diagnoses were categorized according to the DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS, 3rd Edition (DSM-III). Diagnoses derived from the DIS include manic episode, dysthymia, bipolar disorder, single episode major depression, recurrent major depression, atypical bipolar disorder, alcohol abuse or dependence, drug abuse or dependence, schizophrenia, schizophreniform, obsessive compulsive disorder, phobia, somatization, panic, antisocial personality, and anorexia nervosa. The DIS uses the Mini-Mental State Examination (MMSE), which measures cognitive functioning, as an indirect measure of the DSM-III Organic Mental Disorders. In the ECA survey, this diagnosis is called cognitive impairment.

This collection features data from 17,327 participants across 2,005 variables. Data from the Los Angeles, California, Catchment (UCLA) are not included. Baseline data (Wave 1) and Wave 2 data were linked to the National Death Index through 2007, which includes primary and contributing causes of death, International Classification of Disease (ICD) codes, and nature of injury variables.

Sometimes patients don't tell their doctors about all of their symptoms. For example, they may not tell their doctors about having low energy or not sleeping well. These symptoms can be signs of a health problem. Knowing about symptoms can help doctors find ways to help patients feel better. Using patient-reported outcomes (PRO) surveys is one way for doctors to collect this information. These surveys ask how health problems and their treatments affect patients from the patients' point of view. Filling out PRO surveys helps patients tell their doctors how they are feeling.

The research team wanted to know if giving doctors information from their patients about symptoms at the start of an office visit would lead to the patients feeling better. The team collected information from patients about their symptoms using PRO surveys. The surveys tracked five common symptoms: sleep problems, pain, anxiety, depression, and low energy.

The MIDUS Refresher study Survey (2011-2014 ICPSR 36532) recruited a national probability sample of 3,577 adults, aged 25 to 74, designed to replenish the original MIDUS 1 baseline cohort and paralleling the five decadal age groups of the MIDUS 1 baseline survey (ICPSR 2760). The MIDUS Refresher survey employed the same comprehensive assessments as those assembled on the core longitudinal MIDUS sample, but with additional questions about impacts of the economic recession of 2008-09. The MIDUS Refresher Biomarker study (2012-2016) obtained data from 863 respondents (n=746 Main sample, n=117 African Americans from Milwaukee) who completed the MIDUS Refresher Survey.

The purpose of the Refresher Biomarker Project (Project 4) parallels that of the MIDUS 2 Biomarker project (ICPSR 29282), which collected comprehensive biological assessments on a subsample of MIDUS respondents, thus facilitating analyses that integrate behavioral and psychosocial factors with biological regulation/dysregulation, broadly defined. The aim was to use such data to explicate biopsychosocial pathways that contributed to diverse health outcomes. A further theme was to examine period effects on health (mental and physical) related to the economic recession by comparing the pre-recession MIDUS sample with the post-recession MIDUS Refresher sample. A further objective of the MIDUS Refresher sample was to strengthen cross-project analyses by increasing the sample sizes available for testing hypotheses regarding the interplay of key factors (e.g., socioeconomic status, gender, psychosocial factors, biological factors) in mid- and later-life health.

Biomarker data collection was carried out at hypothalamic-pituitary-adrenal axis, the autonomic nervous system, the immune system, cardiovascular system, musculoskeletal system, antioxidants, and three General Clinical Research Centers (at UCLA, University of Wisconsin, and Georgetown University). The biomarkers reflect functioning of the metabolic processes. Our specimens (fasting blood draw, 12-hour urine, saliva) allowed for assessment of multiple indicators within these major systems. The protocol also included assessments by clinicians or trained staff, including vital signs, morphology, functional capacities including 3 dimensional gait analysis, bone densitometry, body composition, ankle brachial index, medication usage, and a physical exam. Project staff obtained indicators of heart-rate variability, beat to beat blood pressure, respiration, and salivary cortisol assessments during an experimental protocol that included both a cognitive and orthostatic challenge. Finally, to augment the self-reported data collected in Survey (Project 1), participants completed a medical history, self-administered questionnaire, and self-reported sleep assessments. For respondents at one site (UW-Madison), objective sleep assessments were also obtained with an Actiwatch(R) activity monitor.

The primary aim of this randomized clinical trial is to compare the effectiveness of the Specific Carbohydrate Diet (SCD) and the Mediterranean style diet (MSD) in inducing symptomatic and clinical remission in patients with Crohn's disease. Secondary objectives are to compare the effectiveness of the SCD and MSD in reducing mucosal and systemic inflammation, assessed by measuring the concentration of fecal calprotectin (FCP) and C-reactive protein (CRP) respectively; to compare the diets' effectiveness in improving fatigue, pain, and joint symptoms; and to determine the proportion of patients who continue study diets when prepared food is no longer provided without cost and their reasons for discontinuing the diets. The research aims were guided by crowdsourcing patient-generated research priorities; those that received the most support from Patient-Powered Research Network (PPRN) members were related to diet.

Based on the book Breaking the Vicious Cycle (Gottschall 1987), the Specific Carbohydrate Diet (SCD) restricts all but simple carbohydrates. Fresh fruits, vegetables, unprocessed meats, lactose-free cheeses, and certain legumes are permitted; grains, processed foods, canned foods, and milk are not permitted. The Mediterranean style diet (MSD) involves a high intake of olive oil, fruit, nuts, vegetables, and cereals; moderate intake of legumes, fish, seafood, and poultry; and low dairy intake. Red and processed meats, soda drinks, bakery foods, and sweets are not permitted. The MSD was selected as the alternative diet in this trial due to its easier implementation, consistency with U.S. Department of Agriculture and World Health Organization recommendations, and evidence of its role in overall health and specific benefits for Crohn's patients.

A total of 194 adult patients with mild to moderate Crohn's disease were enrolled and randomized into either the SCD (intervention) or MSD (control) diet groups at 33 different sites across the United States. Patients received meal delivery for their assigned diet for six weeks, then were provided instructions and recipes to adhere to the diet on their own for weeks seven through twelve. Outcome measures were taken at baseline, six weeks, and twelve weeks.

Patients treated for metastatic cancer, or cancer that has spread to another part of the body, often have symptoms from cancer and its treatment. They may feel tired, depressed, or nauseated. They may find it hard to do their usual activities. Better symptom tracking may help improve patients' care. For example, symptom tracking could quickly alert doctors when a patient may need a different medicine. In this study, the research team compared use of a weekly electronic symptom tracking system versus usual care for patients with cancer. Patients receiving usual care could report their symptoms to their care team during regular clinic visits. The research team wanted to see if the tracking system helped patients live longer, have better quality of life, or go to the hospital or emergency room less often. The aims of this study were as follows:

1. Determine whether integrating electronic patient-reported outcomes (ePRO) in cancer care improves patient-centered outcomes;
2. Elicit perspectives about benefit burden tradeoffs for integrating patient-reported outcomes into clinical workflow; and
3. Identify barriers, facilitators, and strategies used by practices to integrate patient-reported outcomes into clinical workflow.

A total of 1,191 patients were enrolled from 52 U.S.-based community oncology practices. Randomization into intervention and control conditions occurred at the site level. Data collected as part of this study included patient clinical information; weekly symptom surveys, quality of life surveys, and cancer care surveys completed by patients; feedback on the ePRO intervention from patients, clinical research associates, nurses, and physicians; and symptom alerts sent to nursing staff. Please note that while qualitative data were collected as part of this study, they are not available.

Objective: To meta-analyze the diagnostic efficiency of checklists for discriminating pediatric bipolar disorder (PBD) from other conditions. Hypothesized moderators included (a) informant - we predicted caregiver report would produce larger effects than youth or teacher report; (b) scale content - scales that include manic symptoms should be more discriminating; and (c) sample design - samples that include healthy control cases or impose stringent exclusion criteria are likely to produce inflated effect sizes.

Methods: Searches in PsycINFO, PubMed, and GoogleScholar generated 4094 hits. Inclusion criteria were (1) sufficient statistics to estimate a standardized effect size, (2) age 18 years or less, and (3) at least 10 cases (4) with diagnoses of PBD based on semi-structured diagnostic interview. Multivariate mixed regression models accounted for nesting of multiple effect sizes from different informants or scales within the same sample.

Results: Data included 63 effect sizes from 8 rating scales across 27 separate samples (N=11,941 youths, 1,834 with PBD). The average effect size was g=1.05. Random effect variance components within study and between study were significant, ps<.00005. Informant, scale content, and sample design all explained significant unique variance, even after controlling for design and reporting quality.

Discussion: Checklists have clinical utility for assessing PBD. Caregiver reports discriminated PBD significantly better than teacher and youth self report, although all three showed discriminative validity. Studies using "distilled" designs with healthy control comparison groups, or stringent exclusion criteria, produced significantly larger effect size estimates that could lead to inflated false positive rates if used as described in clinical practice.

Tsogolo la Thanzi (TLT) was a longitudinal study in Balaka, Malawi designed to examine how young people navigate reproduction in an AIDS epidemic. Tsogolo la Thanzi means "Healthy Futures" in Chichewa, Malawi's most widely spoken language. This particular study contains the Verbal Autopsy data providing information on 36 respondents who died over the study period (2009-2019). These 36 individuals were known to be deceased through recruitment efforts to re-interview the person during a subsequent wave of data collection. However, not all groups of respondents were re-interviewed in 2012, 2015, and 2019. Therefore, the total number of deaths from the original sample is potentially more than what is reported in this particular study. The 36 verbal autopsy cases in this study represent known deaths, and should not be interpreted as an inventory of all deaths that occurred.