scholarly journals Constructing a confidence interval for the fraction who benefit from treatment, using randomized trial data

Biometrics ◽  
2019 ◽  
Vol 75 (4) ◽  
pp. 1228-1239
Author(s):  
Emily J. Huang ◽  
Ethan X. Fang ◽  
Daniel F. Hanley ◽  
Michael Rosenblum
Keyword(s):  
Confidence Interval ◽  
Randomized Trial ◽  
Trial Data

Strategies for Improving Vaccine Delivery: A Cluster-Randomized Trial

2018 ◽  
pp. 101-109
Author(s):  
Linda Y. Fu ◽  
Kathleen Zook ◽  
Janet A. Gingold ◽  
Catherine W. Gillespie ◽  
Christine Briccetti ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Randomized Trial ◽  
Financial Incentives ◽  
Odds Ratio ◽  
Adjusted Odds Ratio ◽  
Immunization Coverage ◽  
Virtual Learning ◽  
Cluster Randomized Trial ◽  
Learning Collaborative ◽  
Cluster Randomized

OBJECTIVE New emphasis on and requirements for demonstrating health care quality have increased the need for evidence-based methods to disseminate practice guidelines. With regard to impact on pediatric immunization coverage, we aimed to compare a financial incentive program (pay-for-performance [P4P]) and a virtual quality improvement technical support (QITS) learning collaborative. METHODS This single-blinded (to outcomes assessor), cluster-randomized trial was conducted among unaffiliated pediatric practices across the United States from June 2013 to June 2014. Practices received either the P4P or QITS intervention. All practices received a Vaccinator Toolkit. P4P practices participated in a tiered financial incentives program for immunization coverage improvement. QITS practices participated in a virtual learning collaborative. Primary outcome was percentage of all needed vaccines received (PANVR). We also assessed immunization up-to-date (UTD) status. RESULTS Data were analyzed from 3, 147 patient records from 32 practices. Practices in the study arms reported similar QI activities (∼6 to 7 activities). We found no difference in PANVR between P4P and QITS (mean ± SE, 90.7% ± 1.1% vs 86.1% ± 1.3%, P = 0.46). Likewise, there was no difference in odds of being UTD between study arms (adjusted odds ratio 1.02, 95% confidence interval 0.68 to 1.52, P = .93). In within-group analysis, patients in both arms experienced nonsignificant increases in PANVR. Similarly, the change in adjusted odds of UTD over time was modest and nonsignificant for P4P but reached significance in the QITS arm (adjusted odds ratio 1.28, 95% confidence interval 1.02 to 1.60, P = .03). CONCLUSIONS Participation in either a financial incentives program or a virtual learning collaborative led to self-reported improvements in immunization practices but minimal change in objectively measured immunization coverage.

scholarly journals Comparing Telephone Counseling With Reminding to Promote On-Time Repeated Mammography: A Randomized Trial in a Cohort With 4 Years Follow-Up

2019 ◽  
Vol 47 (1) ◽  
pp. 37-46
Author(s):  
Mary E. Costanza ◽  
Roger Luckmann ◽  
Christine Frisard ◽  
Mary Jo White ◽  
Caroline Cranos
Keyword(s):  
Confidence Interval ◽  
Randomized Trial ◽  
Odds Ratio ◽  
Multivariable Analysis ◽  
Telephone Counseling ◽  
Long Term Effects ◽  
Time Points ◽  
Reminder Call ◽  
Screening Mammograms

Background. Long-term continuous adherence to biennial screening mammograms as guidelines recommend remains low. Limited evidence suggests that reminder calls may increase short-term adherence as much as telephone counseling, but research is needed comparing the long-term effects of these two approaches. Purpose. To compare the impacts of two telephone outreach interventions and mailed reminders on 4-year continuous mammography adherence. Method. A cohort of 3,215 women, age 50 to 81 years, was selected from 30,160 women from a 4-year randomized trial of three interventions to promote biennial mammography: reminder letter only (LO), letter plus reminder call (RC), and two letters plus educational material and a counseling call (CC). Women selected remained eligible for the trial all 4 years and received annual interventions as needed. The proportion with a mammogram in the last 24 months was determined at baseline and four annual time points. Results. Continuous adherence at all four time points was higher in the RC (78.8%) and CC arms (78.8%) than in the LO arm (75.1%; p < .001). Multivariable analysis confirmed this finding: CC (odds ratio = 1.27; 95% confidence interval = [1.01, 1.61]) and RC (odds ratio = 1.23; 95% confidence interval = [0.98, 1.56]). Only 27.8% of women eligible for an initial counseling call actually received counseling. Conclusions. Compared with letters alone, outreach calls can modestly increase continuous mammography adherence among insured women with consistent primary care. Telephone counseling was no more effective than a reminder call, possibly due to limited acceptance of counseling calls by women who may find them unwelcome or unnecessary.

Studies Using Randomized Trial Data to Compare Nonrandomized Exposures

2020 ◽  
Vol 172 (7) ◽  
pp. 492 ◽  
Author(s):  
Catharine B. Stack ◽  
Anne R. Meibohm ◽  
Joshua M. Liao ◽  
Eliseo Guallar
Keyword(s):  
Randomized Trial ◽  
Trial Data

Randomized Trials

2019 ◽  
pp. 107-138
Author(s):  
Daniel Westreich
Keyword(s):  
Randomized Trial ◽  
Subgroup Analysis ◽  
Randomized Trials ◽  
Trial Data ◽  
Causal Interaction ◽  
Effect Measure ◽  
Effect Measure Modification ◽  
Broad Overview ◽  
Quantitative Approaches

In Chapter 5, the author describes randomized trials. The chapter gives a broad overview of types of trials and the steps in conducting a trial and also describes how trials meet (and fail to meet) core causal identification conditions. The author provides a brief introduction to the analysis of randomized trial data. As well, the chapter introduces factorial trials as well as subgroup analysis of trials as a way of explaining differences between causal interaction and effect measure modification. Finally, the author describes issues in the generalizability and transportability of trials and quantitative approaches to these issues.

scholarly journals Validation of an Automated Safety Surveillance System with Prospective, Randomized Trial Data

2008 ◽  
Vol 29 (2) ◽  
pp. 247-256 ◽  
Author(s):  
Michael E. Matheny ◽  
David A. Morrow ◽  
Lucila Ohno-Machado ◽  
Christopher P. Cannon ◽  
Marc S. Sabatine ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Surveillance System ◽  
Trial Data ◽  
Prospective Randomized Trial ◽  
Safety Surveillance

Does Non-Neurologic Multiorgan Dysfunction After Out-of-Hospital Cardiac Arrest among Children Admitted in Coma Predict Outcome 1 Year Later?

2020 ◽  
Author(s):  
Kelly L. Corbett ◽  
Angela P. Presson ◽  
Chong Zhang ◽  
Yizhe Xu ◽  
Susan L. Bratton ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Cardiac Arrest ◽  
Data Analysis ◽  
Confidence Interval ◽  
Randomized Trial ◽  
Secondary Data ◽  
Multiorgan Dysfunction ◽  
Hospital Cardiac Arrest ◽  
Multiorgan Dysfunction Syndrome

AbstractWe investigated if non-neurologic multiorgan dysfunction syndrome (MODS) following out-of-hospital cardiac arrest (OHCA) predicts poor 12-month survival. We conducted a secondary data analysis of therapeutic hypothermia after pediatric cardiac arrest out-of-hospital randomized trial involving children who remained unconscious and intubated after OHCA (n = 237). Associations between MODS and 12-month outcomes were assessed using multivariable logistic regression. Non-neurologic MODS was present in 95% of patients and sensitive (97%; 95% confidence interval [CI]: 93–99%) for 12-month survival but had poor specificity (10%; 95% CI: 4–21%). Development of non-neurologic MODS is not helpful to predict long-term neurologic outcome or survival after OHCA.

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