A Master Protocol Template for Pediatric ARDS Studies.

BACKGROUND: Pediatric ARDS is associated with significant morbidity and mortality. High-quality data from clinical trials in children are limited due to numerous barriers to their design and execution. Here we describe the collaborative development of a master protocol as a tool to address some of these barriers and support the conduct of pediatric ARDS studies. METHODS: Using PubMed, we performed a literature search of randomized controlled trials (RCTs) in pediatric ARDS to characterize the current state and evaluate potential benefit of harmonized master protocols. We used a multi-stakeholder, collaborative, and team science-oriented process to develop a master protocol template with links to common data elements (CDEs) for pediatric ARDS trials. RESULTS: We identified 11 RCTs that enrolled between 14-200 total subjects per trial. Interventions included mechanical ventilation, prone positioning, corticosteroids, and surfactant. Studies displayed significant heterogeneity in ARDS definition, design, inclusion and exclusion criteria, and reported outcomes. Mortality was reported in 91% of trials and ventilator-free days in 73%. The trial heterogeneity made pooled analysis unfeasible. These findings underscore the need for a method to facilitate combined analysis of future trials through standardization of trial elements. As a potential solution, we developed a master protocol, iteratively revised with input from a multidisciplinary panel of experts and organized into 3 categories: instructions and general information, templated language, and a series of text options of common pediatric ARDS trial scenarios. Finally, we linked master protocol sections to relevant CDEs previously defined for pediatric ARDS and captured in a series of electronic case report forms. CONCLUSIONS: The majority of pediatric ARDS trials identified were small and heterogeneous in study design and outcome reporting. Using a master protocol template for pediatric ARDS trials with CDEs would support combining and comparing pediatric ARDS trial findings and increase the knowledge base.

You & Me: Test and Treat study protocol for promoting COVID-19 test and treatment access to underserved populations.

BACKGROUND: Infections and deaths from the COVID-19 pandemic have disproportionately affected underserved populations. A community-engaged approach that supports decision making around safe COVID-19 practices is needed to promote equitable access to testing and treatment. You & Me: Test and Treat (YMTT) will evaluate a systematic and scalable community-engaged protocol that provides rapid access to COVID-19 at-home tests, education, guidance on next steps, and information on local resources to facilitate treatment in underserved populations. METHODS: This direct-to-participant observational study will distribute at-home, self-administered, COVID-19 testing kits to people in designated communities. YMTT features a Public Health 3.0 framework and Toolkit prescribing a tiered approach to community engagement. We will partner with two large community organizations, Merced County United Way (Merced County, CA) and Pitt County Health Department (Pitt County, NC), who will coordinate up to 20 local partners to distribute 40,000 COVID tests and support enrollment, consenting, and data collection over a 15-month period. Participants will complete baseline questions about their demographics, experience with COVID-19 infection, and satisfaction with the distribution event. Community partners will also complete engagement surveys. In addition, participants will receive guidance on COVID-19 mitigation and health-promoting resources, and accessible and affordable therapeutics if they test positive for COVID-19. Data collection will be completed using a web-based platform that enables creation and management of electronic data capture forms. Implementation measures include evaluating 1) the Toolkit as a method to form community-academic partnerships for COVID-19 test access, 2) testing results, and 3) the efficacy of a YMTT protocol coupled with local resourcing to provide information on testing, guidance, treatment, and links to resources. Findings will be used to inform innovative methods to address community needs in public health research that foster cultural relevance, improve research quality, and promote health equity. DISCUSSION: This work will promote access to COVID-19 testing and treatment for underserved populations by leveraging a community-engaged research toolkit. Future dissemination of the toolkit can support effective community-academic partnerships for health interventions in underserved settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05455190 . Registered 13 July 2022.

Public health news frames in North Carolina newspaper coverage of the 100% Tobacco-Free Schools campaign? Sometimes.

OBJECTIVE: News organizations are an important and influential part of the social environment. They identify certain issues by the extent and nature of their coverage. To help explain what public health policy messages may have influenced school policy decisions, this content analysis provides an examination of newspaper coverage of North Carolinas 100% tobacco-free schools campaign. DATA COLLECTION METHODS: Researchers searched LexisNexis for articles published in North Carolina newspapers between January 1, 2001 and December 31, 2004 that included variations of "North Carolina tobacco-free schools." Researchers then conducted a descriptive analysis of 138 stories from nine North Carolina newspapers (approximately 4% of all the states newspapers) and used page placement and story type to examine the level of importance placed on the issue. Finally, frames for and against tobacco-free school policies were tracked, along with the presence of key messages presented by 100% TFS advocates. PRINCIPAL FINDINGS: The volume of news coverage changed throughout the study period, with peaks and valleys closely associated with external "trigger" events. In addition, a majority of the newspaper articles did not include key public health messages. CONCLUSIONS: The results suggest an opportunity for public health experts and officials to work more effectively with local journalists to increase the use (and impact) of public health messages in news coverage of tobacco policies affecting youth.

Assessing the need to update prevention guidelines: a comparison of two methods.

BACKGROUND: An important concern for developers of clinical practice guidelines is how best to determine when guidelines require updating to ensure they remain current and evidence based. Because of the high costs associated with updating guidelines, recent attention has focused on approaches that can reliably assess the extent of updating required. Recently, Shekelle and colleagues proposed a model of limited literature searches with modest expert involvement as a way to reduce the cost and time requirements for assessing whether a guideline needs updating. METHODS: The main objective of this study was to compare the Shekelle et al. assessment model (review approach) and a conventional process using typical systematic review methods (traditional approach) in terms of comprehensiveness and effort. We modeled the review approach on that by Shekelle and colleagues but refined it iteratively over three phases to achieve greater efficiency. Using both methods independently, we assessed the need to update six topics from the 1996 Guide to Clinical Preventive Services from the US Preventive Services Task Force. Main outcomes included completeness of study identification, importance of missed studies and the effort involved. RESULTS: Although the review approach identified fewer eligible studies than the traditional approach, none of the studies missed was rated as important by task force members acting as liaisons to the project with respect to whether the topic required an update. On average, the review approach produced substantially fewer citations to review than the traditional approach. The effort involved and potential time saving depended largely on the scope of the topic. CONCLUSIONS: The revised review approach provides an efficient and acceptable method for judging whether a guideline requires updating.

Exercise tolerance testing to screen for coronary heart disease: a systematic review for the technical support for the U.S. Preventive Services Task Force.

BACKGROUND: Coronary heart disease is the leading cause of morbidity and mortality in the United States. Exercise tolerance testing has been proposed as a means of better identifying asymptomatic patients at high risk for coronary heart disease events. PURPOSE: To review the evidence on the use of exercise tolerance testing to screen adults with no history of cardiovascular disease for coronary heart disease. DATA SOURCES: The MEDLINE database from 1966 through February 2003, hand-searching of bibliographies, and expert input. STUDY SELECTION: Eligible studies evaluated the benefits or harms of exercise tolerance testing when added to traditional risk assessment for adults with no known history of cardiovascular events. DATA EXTRACTION: One reviewer extracted information from eligible articles into evidence tables, and another reviewer checked the tables. Disagreements were resolved by consensus. DATA SYNTHESIS: No study has directly examined the effect of screening asymptomatic patients with exercise tolerance testing on coronary heart disease outcomes or risk-reducing behaviors or therapies. Multiple cohort studies demonstrate that screening exercise tolerance testing identifies a small proportion of asymptomatic persons (up to 2.7% of those screened) with severe coronary artery obstruction who may benefit from revascularization. Several large prospective cohort studies, conducted principally in middle-aged men, suggest that exercise tolerance testing can provide independent prognostic information about the risk for future coronary heart disease events (relative risk with abnormal exercise tolerance testing, 2.0 to 5.0). However, when the risk for coronary heart disease events is low, most positive findings will be false and may result in unnecessary further testing or worry. The risk level at which the benefits of additional prognostic information outweigh the harms of false-positive results is unclear and requires further study. CONCLUSIONS: Although screening exercise tolerance testing detects severe coronary artery obstruction in a small proportion of persons screened and can provide independent prognostic information about the risk for coronary heart disease events, the effect of this information on clinical management and disease outcomes in asymptomatic patients is unclear.

Diagnosis and testing in bronchiolitis: a systematic review.

BACKGROUND: The diagnosis of bronchiolitis is based on typical history and results of a physical examination. The indications for and utility of diagnostic and supportive laboratory testing (eg, chest x-ray films, complete blood cell counts, and respiratory syncytial virus testing) are unclear. OBJECTIVES: To review systematically the data on diagnostic and supportive testing in the management of bronchiolitis and to assess the utility of such testing. DESIGN: In conjunction with an expert panel, we generated admissibility criteria and derived relevant terms to search the literature published from 1980 to November 2002 in MEDLINE and the Cochrane Collaboration Database of Controlled Clinical Trials. Trained abstractors completed detailed data collection forms for each article. We summarized the data in tables after performing data integrity checks. RESULTS: Of the 797 abstracts identified, we present evidence from 82 trials that met our inclusion criteria (17 are primary articles on diagnosis of bronchiolitis and 65are reports of treatment or prevention trials). Numerous studies demonstrate that rapid respiratory syncytial virus tests have acceptable sensitivity and specificity, but no data show that respiratory syncytial virus testing affects clinical outcomes in typical cases of the disease. Seventeen studies presented chest x-ray film data. Abnormalities on chest x-ray films ranged from 20% to 96%. Insufficient data exist to show that chest x-ray films reliably distinguish between viral and bacterial disease or predict severity of disease. Ten studies included complete blood cell counts, but most did not present specific results. In one study, white blood cell counts correlated with radiologically defined disease categories of bronchiolitis. CONCLUSIONS: A large number of studies include diagnostic and supportive testing data. However, these studies do not define clear indications for such testing or the impact of testing on relevant patient outcomes. Given the high prevalence of this disease, prospective studies of the utility of such testing are needed and feasible.

Pharmacologic treatment of bronchiolitis in infants and children: a systematic review.

BACKGROUND: Bronchiolitis is the most common lower respiratory tract infection in infants. Up to 3% of all children in their first year of life are hospitalized with bronchiolitis. Bronchodilators and corticosteroids are commonly used treatments, but little consensus exists about optimal management strategies. OBJECTIVE: To conduct a systematic review of the effectiveness of commonly used treatments for bronchiolitis in infants and children. DATA SOURCES: We searched MEDLINE and the Cochrane Controlled Trials Register for references to randomized controlled trials of bronchiolitis treatment published since 1980. STUDY SELECTION: Randomized controlled trials of interventions for bronchiolitis in infants and children were included if they were published in English between 1980 and November 2002 and had a minimum sample size of 10. DATA EXTRACTION: We abstracted data on characteristics of the study population, interventions used, and results of studies meeting entry criteria into evidence tables and analyzed them by drug category. DATA SYNTHESIS: Interventions were grouped by drug category and qualitatively synthesized. RESULTS: Of 797 abstracts identified in the literature search, we included 54 randomized controlled trials. This review includes 44 studies of the most common interventions: epinephrine (n = 8), beta2-agonist bronchodilators (n = 13), corticosteroids (n = 13), and ribavirin (n = 10). Studies were, in general, underpowered to detect statistically significant outcome differences between study groups. Few studies collected data on outcomes that are of great importance to parents and clinicians, such as the need for and duration of hospitalization. CONCLUSIONS: Overall, little evidence supports a routine role for any of these drugs in treating patients with bronchiolitis. A sufficiently large, well-designed pragmatic trial of the commonly used interventions for bronchiolitis is needed to determine the most effective treatment strategies for managing this condition.

Screening and interventions for obesity in adults: summary of the evidence for the U.S. Preventive Services Task Force.

BACKGROUND: Obesity poses a considerable and growing health burden. This review examines evidence for screening and treating obesity in adults. DATA SOURCES: MEDLINE and Cochrane Library (January 1994 through February 2003). STUDY SELECTION: Systematic reviews; randomized, controlled trials; and observational studies of obesity's health outcomes or efficacy of obesity treatment. DATA EXTRACTION: Two reviewers independently abstracted data on study design, sample, sample size, treatment, outcomes, and quality. DATA SYNTHESIS: No trials evaluated mass screening for obesity, so the authors evaluated indirect evidence for efficacy. Pharmacotherapy or counseling interventions produced modest (generally 3 to 5 kg) weight loss over at least 6 or 12 months, respectively. Counseling was most effective when intensive and combined with behavioral therapy. Maintenance strategies helped retain weight loss. Selected surgical patients lost substantial weight (10 to 159 kg over 1 to 5 years). Weight reduction improved blood pressure, lipid levels, and glucose metabolism and decreased diabetes incidence. The internal validity of the treatment trials was fair to good, and external validity was limited by the minimal ethnic or gender diversity of volunteer participants. No data evaluated counseling harms. Primary adverse drug effects included hypertension with sibutramine (mean increase, 0 mm Hg to 3.5 mm Hg) and gastrointestinal distress with orlistat (1% to 37% of patients). Fewer than 1% (pooled samples) of surgical patients died; up to 25% needed surgery again over 5 years. CONCLUSIONS: Counseling and pharmacotherapy can promote modest sustained weight loss, improving clinical outcomes. Pharmacotherapy appears safe in the short term; long-term safety has not been as strongly established. In selected patients, surgery promotes large amounts of weight loss with rare but sometimes severe complications.

Counseling to promote a healthy diet in adults: a summary of the evidence for the U.S. Preventive Services Task Force.

OBJECTIVE: The purpose of this study was to examine the effectiveness of counseling to promote a healthy diet among patients in primary care settings. DESIGN AND DATA SOURCES: We conducted a MEDLINE search from 1966 to December 2001. STUDY SELECTION: We included randomized controlled trials of at least 3 months' duration with measures of dietary behavior that were conducted in patient populations similar to those found in primary care practices. We excluded studies that reported only biochemical or anthropomorphic endpoints, had dropout rates greater than 50%, or enrolled patients based on the presence of a chronic disease. DATA EXTRACTION: One author extracted relevant data from each included article into evidence tables. Using definitions developed by the research team, two authors independently rated each study in terms of its effect size, the intensity of its intervention, the patient risk level, and the use of well-proven counseling techniques. DATA SYNTHESIS: We identified 21 trials for use in this review. Dietary counseling produces modest changes in self-reported consumption of saturated fat, fruits and vegetables, and possibly dietary fiber. More-intensive interventions were more likely to produce important changes than brief interventions, but they may be more difficult to apply to typical primary care patients. Interventions using interactive health communications, including computer-generated telephone or mail messages, can also produce moderate dietary changes. CONCLUSIONS: Moderate- or high-intensity counseling interventions, including use of interactive health communication tools, can reduce consumption of saturated fat and increase intake of fruit and vegetable. Brief counseling of unselected patients by primary care providers appears to produce small changes in dietary behavior, but its effect on health outcomes is unclear.