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Propensity score matching for treatment delay effects with observational survival data

Hade, Erinn M; Nattino, Giovanni; Frey, Heather A; Lu, Bo
In observational studies with a survival outcome, treatment initiation may be time dependent, which is likely to be affected by both time-invariant and time-varying covariates. In situations where the treatment is necessary for the study population, all or most subjects may be exposed to the treatment sooner or later. In this scenario, the causal effect of interest is the delay in treatment reception. A simple comparison of those receiving treatment early vs. those receiving treatment late might not be appropriate, as the timing of the treatment reception is not randomized. Extending Lu's matching design with time-varying covariates, we propose a propensity score matching strategy to estimate the treatment delay effect. The goal is to balance the covariate distribution between on-time treatment and delayed treatment groups at each time point using risk set matching. Our simulation study shows that, in the presence of treatment delay effects, the matching-based analyses clearly outperform the conventional regression analysis using the naive Cox proportional hazards model. We apply this method to study the treatment delay effect of 17 alpha-hydroxyprogesterone caproate (17P) for patients with recurrent preterm birth.
PMID: 31571522
ISSN: 1477-0334
CID: 4691592

The Association of Moms2B, a Community-Based Interdisciplinary Intervention Program, and Pregnancy and Infant Outcomes among Women Residing in Neighborhoods with a High Rate of Infant Mortality

Hade, Erinn M; Lynch, Courtney D; Benedict, Jason A; Smith, Rachel M; Ding, Danielle D; Gabbe, Steven G; Gabbe, Patricia Temple
OBJECTIVES/OBJECTIVE:We evaluated the effectiveness of Moms2B, a community-based group pregnancy and parenting program, in an effort to assess whether the program improved pregnancy and infant outcomes. METHODS:We conducted a retrospective matched exposure cohort study comparing women exposed to the Moms2B program during pregnancy (two or more prenatal visits) who delivered a singleton live birth or stillbirth (≥ 20 weeks gestation) from 2011-2017 to a closely matched group of women not exposed to the program. Primary outcomes were preterm birth and low birth weight. Propensity score methods were used to provide strong control for confounders. RESULTS:The final analytic file comprised 675 exposed pregnancies and a propensity score-matched group of 1336 unexposed pregnancies. Most of the women were non-Hispanic Black. We found evidence of better outcomes among pregnancies exposed to Moms2B versus unexposed pregnancies, particularly for the primary outcome of low birth weight [9.45% versus 12.00%, respectively, risk difference (RD) = -2.55, 95% confidence interval (CI) = (-5.44, 0.34)]. Point estimates for all adverse pregnancy outcomes uniformly favored exposure to Moms2B. CONCLUSIONS FOR PRACTICE/UNASSIGNED:Our findings suggest that participation in the Moms2B program improves pregnancy and infant outcomes. The program offers an innovative group model of pregnancy and parenting support for women, especially in non-Hispanic Black women with high-risk pregnancies.
PMID: 33471249
ISSN: 1573-6628
CID: 4762812

Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis

Minneci, Peter C; Hade, Erinn M; Lawrence, Amy E; Sebastião, Yuri V; Saito, Jacqueline M; Mak, Grace Z; Fox, Christa; Hirschl, Ronald B; Gadepalli, Samir; Helmrath, Michael A; Kohler, Jonathan E; Leys, Charles M; Sato, Thomas T; Lal, Dave R; Landman, Matthew P; Kabre, Rashmi; Fallat, Mary E; Cooper, Jennifer N; Deans, Katherine J
Importance:Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery. Objective:To determine the success rate of nonoperative management and compare differences in treatment-related disability, satisfaction, health-related quality of life, and complications between nonoperative management and surgery in children with uncomplicated appendicitis. Design, Setting, and Participants:Multi-institutional nonrandomized controlled intervention study of 1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019. Of the 1209 eligible patients approached, 1068 enrolled in the study. Interventions:Patient and family selection of nonoperative management with antibiotics alone (nonoperative group, n = 370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n = 698). Main Outcomes and Measures:The 2 primary outcomes assessed at 1 year were disability days, defined as the total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care (expected difference, 5 days), and success rate of nonoperative management, defined as the proportion of patients initially managed nonoperatively who did not undergo appendectomy by 1 year (lowest acceptable success rate, ≥70%). Inverse probability of treatment weighting (IPTW) was used to adjust for differences between treatment groups for all outcome assessments. Results:Among 1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery. A total of 806 (75%) had complete follow-up: 284 (77%) in the nonoperative group; 522 (75%) in the surgery group. Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%). After IPTW, the success rate of nonoperative management at 1 year was 67.1% (96% CI, 61.5%-72.31%; P = .86). Nonoperative management was associated with significantly fewer patient disability days at 1 year than did surgery (adjusted mean, 6.6 vs 10.9 days; mean difference, -4.3 days (99% CI, -6.17 to -2.43; P < .001). Of 16 other prespecified secondary end points, 10 showed no significant difference. Conclusion and Relevance:Among children with uncomplicated appendicitis, an initial nonoperative management strategy with antibiotics alone had a success rate of 67.1% and, compared with urgent surgery, was associated with statistically significantly fewer disability days at 1 year. However, there was substantial loss to follow-up, the comparison with the prespecified threshold for an acceptable success rate of nonoperative management was not statistically significant, and the hypothesized difference in disability days was not met. Trial Registration:ClinicalTrials.gov Identifier: NCT02271932.
PMID: 32730561
ISSN: 1538-3598
CID: 4691652

Interpregnancy interval and preterm delivery: An empirical comparison of between-persons and within-sibship designs

Klebanoff, Mark A; Hade, Erinn M
BACKGROUND:Short interpregnancy interval has been associated with increased risk of preterm delivery; recent studies employing within-sibship designs suggest that this risk may be exaggerated. There are unresolved issues regarding properties of this design. OBJECTIVES/OBJECTIVE:To compare directly the results, for short intervals, of between-person and within-sibship analyses when applied to the same target population. METHODS:Cross-sectional data are from the National Survey of Family Growth, a statistically representative survey of women and men in the USA, 2006-2015. Participants provided a complete pregnancy history including outcome, duration and ending date, enabling calculation of interval. Conventional analysis employed log-linear regression, controlling survey design, early life events, demographic variables, pregnancy intendedness, breastfeeding of the previous birth and obstetric history. Within-sibship analyses, utilising conditional log-linear regression, controlled the same variables, except those remaining static within each participant. RESULTS:Among participants with at least three live- or stillbirths, the percentage of pregnancies in each interval, and the percent of deliveries that were preterm following that interval were 9.2%, 14.6% for <6, and 14.7%, 15.4% for 6-11, versus 12.2%, 14.7% for 18-23 months. Among participants with at least three live- or stillborn infants, those in the within-sibship analysis had a higher risk profile than comparably parous, ineligible participants. In a between-participant analysis, among those included in within-sibship models, the adjusted risk ratios (vs 18-23 months) for preterm delivery for intervals <6 and 6-11 months were 0.74 (95% CI 0.63, 0.88) and 0.85 (95% CI 0.74, 0.98). The corresponding risk ratios were 0.56 (95% CI 0.14, 2.30) and 0.49 (95% CI 0.13, 1.80) for those ineligible for the within-sibship models. CONCLUSIONS:When comparable analyses were employed, the association between interval and preterm delivery was similar between participants included in the within-sibship analysis and those ineligible for the within-sibship analysis, but differed from those in the full cohort, perhaps due to different target populations.
PMID: 36511351
ISSN: 1365-3016
CID: 5382002

Cutoff designs for community-based intervention studies

Pennell, Michael L; Hade, Erinn M; Murray, David M; Rhoda, Dale A
Public health interventions are often designed to target communities defined either geographically (e.g. cities, counties) or socially (e.g. schools or workplaces). The group randomized trial (GRT) is regarded as the gold standard for evaluating these interventions. However, community leaders may object to randomization as some groups may be denied a potentially beneficial intervention. Under a regression discontinuity design (RDD), individuals may be assigned to treatment based on the levels of a pretest measure, thereby allowing those most in need of the treatment to receive it. In this article, we consider analysis, power, and sample size issues in applying the RDD and related cutoff designs in community-based intervention studies. We examine the power of these designs as a function of intraclass correlation, number of groups, and number of members per group and compare results to the traditional GRT.
PMID: 21500240
ISSN: 1097-0258
CID: 4690952

Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival

Hade, Erinn M; Young, Gregory S; Love, Richard R
BACKGROUND:While the clinical trials and statistical methodology literature on sample size re-estimation (SSRE) is robust, evaluation of SSRE procedures following the completion of a clinical trial has been sparsely reported. In blinded sample size re-estimation, only nuisance parameters are re-estimated, and the blinding of the current trial treatment effect is preserved. Blinded re-estimation procedures are well-accepted by regulatory agencies and funders. We review our experience of sample size re-estimation in a large international, National Institutes of Health funded clinical trial for adjuvant breast cancer treatment, and evaluate our blinded sample size re-estimation procedure for this time-to-event trial. We evaluated the SSRE procedure by examining assumptions made during the re-estimation process, estimates resulting from re-estimation, and the impact on final trial results with and without the addition of participants, following sample size re-estimation. METHODS:We compared the control group failure probabilities estimated at the time of SSRE to estimates used in the original planning, to the final un-blinded control group failure probability estimates for those included in the SSRE procedure (SSRE cohort), and to the final total control group failure probability estimates. The impact of re-estimation on the final comparison between randomized treatment groups is evaluated for those in the originally planned cohort (n = 340) and for the combination of those recruited in the originally planned cohort and those added after re-estimation (n = 509). RESULTS:Very little difference is observed between the originally planned cohort and all randomized patients in the control group failure probabilities over time or in the overall hazard ratio estimating treatment effect (originally planned cohort HR 1.25 (0.86, 1.79); all randomized cohort HR 1.24 95% CI (0.91, 1.68)). At the time of blinded SSRE, the estimated control group failure probabilities at 3 years (0.24) and 5 years (0.40) were similar to those for the SSRE cohort once un-blinded (3 years, 0.22 (0.16, 0.30); 5 years, 0.33 (0.26, 0.41)). CONCLUSIONS:We found that our re-estimation procedure performed reasonably well in estimating the control group failure probabilities at the time of re-estimation. Particularly for time-to-event outcomes, pre-planned blinded SSRE procedures may be the best option to aid in maintaining power. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov, NCT00201851 . Registered on 9 September 2005. Retrospectively registered.
PMCID:6708130
PMID: 31443726
ISSN: 1745-6215
CID: 4691552

Bias associated with using the estimated propensity score as a regression covariate

Hade, Erinn M; Lu, Bo
The use of propensity score methods to adjust for selection bias in observational studies has become increasingly popular in public health and medical research. A substantial portion of studies using propensity score adjustment treat the propensity score as a conventional regression predictor. Through a Monte Carlo simulation study, Austin and colleagues. investigated the bias associated with treatment effect estimation when the propensity score is used as a covariate in nonlinear regression models, such as logistic regression and Cox proportional hazards models. We show that the bias exists even in a linear regression model when the estimated propensity score is used and derive the explicit form of the bias. We also conduct an extensive simulation study to compare the performance of such covariate adjustment with propensity score stratification, propensity score matching, inverse probability of treatment weighted method, and nonparametric functional estimation using splines. The simulation scenarios are designed to reflect real data analysis practice. Instead of specifying a known parametric propensity score model, we generate the data by considering various degrees of overlap of the covariate distributions between treated and control groups. Propensity score matching excels when the treated group is contained within a larger control pool, while the model-based adjustment may have an edge when treated and control groups do not have too much overlap. Overall, adjusting for the propensity score through stratification or matching followed by regression or using splines, appears to be a good practical strategy.
PMCID:4004383
PMID: 23787715
ISSN: 1097-0258
CID: 4691042

The Registry-Based Randomized Trial - A Pragmatic Study Design [Editorial]

Troxel, Andrea B; Hade, Erinn M
Randomized controlled trials are the gold standard of clinical research for comparing therapies in well-defined groups of participants.1 Randomization avoids confounding due to unmeasured variables or to treatment selection and enables a causal interpretation of the estimated treatment effect. It has long been recognized, however, that standard explanatory clinical trials are slow, costly, and subject to participant selection. To preserve the strengths of randomized trials while mitigating their weaknesses, pragmatic randomized clinical trials emerged; these trials aim to facilitate decision-making rather than explicate a mechanism of action and enroll a diverse set of participants using existing structures and data sources.2.
PMID: 38320494
ISSN: 2766-5526
CID: 5632552

Conditional logistic versus conditional Poisson regression in sibship studies of interpregnancy interval

Klebanoff, Mark A; Hade, Erinn M
PMID: 38330206
ISSN: 1365-3016
CID: 5632382

Estimating the effect of diuretics and inhaled corticosteroids for evolving bronchopulmonary dysplasia in preterm infants

Slaughter, Jonathan L.; Klebanoff, Mark A.; Hade, Erinn M.
Background: Off-label treatment of extremely preterm infants with diuretics and inhaled corticosteroids (ICS) for evolving bronchopulmonary dysplasia (BPD) is common. Their effectiveness in reducing mortality or BPD severity, and optimal treatment timing, are unclear. Objectives: To determine whether diuretic treatment or ICS administration for infants with early evolving (between 10"“27 days postnatal) and progressively evolving (28th-day"“36th-week postnatal) BPD are independently associated with reduced mortality and moderate or severe BPD at 36-weeks postmenstrual age (PMA). Methods: We examined neonates born before 28 weeks' gestation and admitted to neonatal intensive care units on postnatal Day 0 between 2006 and 2016 using data collected during routine care recorded within the Paediatric Health Information System (PHIS). An early evolving BPD cohort consisted of infants treated with oxygen, positive pressure or mechanical ventilation at 10 days postnatal. The progressively evolving BPD cohort consisted of infants treated with these modalities at 28 days. In new users, we evaluated the effect of diuretic and ICS treatment on mortality or BPD severity at 36 weeks PMA, adjusting for time-dependent confounding by respiratory status using marginal structural models. Results: Early evolving BPD was present in 10,135 patients; progressively evolving BPD in 11,728. New diuretic exposure during early evolving BPD (adjusted risk ratio [aRR] 0.77, 95% confidence interval [CI] 0.65, 0.93) was associated with decreased mortality or moderate/severe BPD risk. New diuretics (aRR 0.86, 95% CI 0.75, 0.99) during progressively evolving BPD between 28-days"“36-weeks PMA were less strongly associated with mortality or moderate/severe BPD reduction. There was no strong association for ICS in patients with early evolving (aRR: 1.40; 95% CI: 0.79, 2.51) or progressively evolving BPD (aRR 1.16, 95% CI 0.95, 1.49). Conclusion: Diuretics, but not ICS, for evolving BPD were associated with mortality and BPD risk reduction.
SCOPUS:85181709826
ISSN: 0269-5022
CID: 5630112