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Browsing by Author "Hade, Erinn M."
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Item Advanced Therapy in Traumatic Brain Injury Inpatient Rehabilitation: Effects on Outcomes During the First Year after Discharge(Elsevier, 2019) Timpson, Misti; Hade, Erinn M.; Beaulieu, Cynthia; Horn, Susan D.; Hammond, Flora M.; Peng, Juan; Montgomery, Erin; Giuffrida, Clare; Gilchrist, Kamie; Lash, Aubrey; Dijkers, Marcel; Corrigan, John D.; Bogner, Jennifer; Physical Medicine and Rehabilitation, School of MedicineObjective To use causal inference methods to determine if receipt of a greater proportion inpatient rehabilitation treatment focused on higher level functions, e.g. executive functions, ambulating over uneven surfaces (Advanced Therapy, AdvTx) results in better rehabilitation outcomes. Design A cohort study using propensity score methods applied to the TBI-Practice-Based Evidence (TBI-PBE) database, a database consisting of multi-site, prospective, longitudinal observational data. Setting Acute inpatient rehabilitation (IRF). Participants Patients enrolled in the TBI-PBE study (n=1843), aged 14 years or older, who sustained a severe, moderate, or complicated mild TBI, receiving their first IRF admission to one of 9 sites in the US, and consented to follow-up 3 and 9 months post discharge from inpatient rehabilitation. Interventions Not applicable. Main Outcome Measures: Participation Assessment with Recombined Tools-Objective-17, FIMTM Motor and Cognitive scores, Satisfaction with Life Scale, and Patient Health Questionnaire-9. Results Controlling for measured potential confounders, increasing the percentage of AdvTx during inpatient TBI rehabilitation was found to be associated with better community participation, functional independence, life satisfaction, and decreased likelihood of depression during the year following discharge from inpatient rehabilitation. Participants who began rehabilitation with greater disability experienced larger gains on some outcomes than those who began rehabilitation with more intact abilities. Conclusions Increasing the proportion of treatment targeting higher level functions appears to have no detrimental and a small, beneficial effect on outcome. Caution should be exercised when inferring causality given that a large number of potential confounders could not be completely controlled with propensity score methods. Further, the extent to which unmeasured confounders influenced the findings is not known and could be of particular concern due to the potential for the patient’s recovery trajectory to influence therapists’ decisions to provide a greater amount AdvTx.Item Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis(American Medical Association, 2020-08) 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.; Surgery, School of MedicineImportance: 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.Item Contextualized Treatment in Traumatic Brain Injury Inpatient Rehabilitation: Effects on Outcomes During the First Year after Discharge(Elsevier, 2019) Bogner, Jennifer; Dijkers, Marcel; Hade, Erinn M.; Beaulieu, Cynthia; Montgomery, Erin; Giuffrida, Clare; Timpson, Misti; Peng, Juan; Gilchrist, Kamie; Lash, Aubrey; Hammond, Flora M.; Horn, Susan; Corrigan, John; Physical Medicine and Rehabilitation, School of MedicineObjective To evaluate the effect of providing a greater percentage of therapy as contextualized treatment on acute traumatic brain injury (TBI) rehabilitation outcomes. Design Propensity score methods are applied to the TBI-Practice-Based Evidence (TBI-PBE) database, a database consisting of multi-site, prospective, longitudinal observational data. Setting Acute inpatient rehabilitation. Participants Patients enrolled in the TBI-PBE study (n=1843), aged 14 years or older, who sustained a severe, moderate, or complicated mild TBI, receiving their first IRF admission in the US, and consented to follow-up 3 and 9 months post discharge from inpatient rehabilitation. Interventions Not applicable. Main Outcome Measures Participation Assessment with Recombined Tools-Objective- -17, FIMTM Motor and Cognitive scores, Satisfaction with Life Scale and Patient Health Questionnaire-9. Results Increasing the percentage of contextualized treatment during inpatient TBI rehabilitation leads to better outcomes, specifically in regard to community participation. Conclusions Increasing the proportion of treatment provided in the context of real-life activities appears to have a beneficial impact on outcome. Although the effect sizes are small, the results are consistent with other studies supporting functional-based interventions effecting better outcomes. Furthermore, any positive findings, regardless of size or strength, are endorsed as important by consumers (survivors of TBI). While the findings do not imply that decontextualized treatment should not be used, when the therapy goal can be addressed with either approach, the findings suggest that better outcomes may result if the contextualized approach is used.Item Demographic and Clinical Characteristics Associated With the Failure of Nonoperative Management of Uncomplicated Appendicitis in Children: Secondary Analysis of a Nonrandomized Clinical Trial(JAMA, 2022-05-02) Minneci, Peter C.; Hade, Erinn M.; Gil, Lindsay A.; Metzger, Gregory A.; Saito, Jacqueline M.; Mak, Grace Z.; Hirschl, Ronald B.; Gadepalli, Samir; Helmrath, Michael A.; Leys, Charles M.; Sato, Thomas T.; Lal, Dave R.; Landman, Matthew P.; Kabre, Rashmi; Fallat, Mary E.; Cooper, Jennifer N.; Deans, Katherine J.; Midwest Pediatric Surgery Consortium; Surgery, School of MedicineImportance: The factors associated with the failure of nonoperative management of appendicitis and the differences in patient-reported outcomes between successful and unsuccessful nonoperative management remain unknown. Objectives: To investigate factors associated with the failure of nonoperative management of appendicitis and compare patient-reported outcomes between patients whose treatment succeeded and those whose treatment failed. Design, setting, and participants: This study was a planned subgroup secondary analysis conducted in 10 children's hospitals that included 370 children aged 7 to 17 years with uncomplicated appendicitis enrolled in a prospective, nonrandomized clinical trial between May 1, 2015, and October 31, 2018, with 1-year follow-up comparing nonoperative management with antibiotics vs surgery for uncomplicated appendicitis. Statistical analysis was performed from November 1, 2019, to February 12, 2022. Interventions: Nonoperative management with antibiotics vs surgery. Main outcomes and measures: Failure of nonoperative management and patient-reported outcomes. The relative risk (RR) of failure based on sociodemographic and clinical characteristics was calculated. Patient-reported outcomes were compared based on the success or failure of nonoperative management. Results: Of 370 patients (34.6% of 1068 total patients; 229 boys [61.9%]; median age, 12.3 years [IQR, 10.0-14.6 years]) enrolled in the nonoperative group, treatment failure occurred for 125 patients (33.8%) at 1 year, with 53 patients (14.3%) undergoing appendectomy during initial hospitalization and 72 patients (19.5%) experiencing delayed treatment failure after hospital discharge. Higher patient-reported pain at presentation was associated with increased risk of in-hospital treatment failure (RR, 2.1 [95% CI, 1.0-4.4]) but not delayed treatment failure (RR, 1.3 [95% CI, 0.7-2.3]) or overall treatment failure at 1 year (RR, 1.5 [95% CI, 1.0-2.2]). Pain duration greater than 24 hours was associated with decreased risk of delayed treatment failure (RR, 0.3 [95% CI, 0.1-1.0]) but not in-hospital treatment failure (RR, 1.2 [95% CI, 0.5-2.7]) or treatment failure at 1 year (RR, 0.7 [95% CI, 0.4-1.2]). There was no increased risk of treatment failure associated with age, white blood cell count, sex, race, ethnicity, primary language, insurance status, transfer status, symptoms at presentation, or imaging results. Health care satisfaction at 30 days and patient-reported, health-related quality of life at 30 days and 1 year were not different. Satisfaction with the decision was higher with successful nonoperative management at 30 days (28.0 vs 27.0; difference, 1.0 [95% CI, 0.01-2.0]) and 1 year (28.1 vs 27.0; difference, 1.1 [95% CI, 0.2-2.0]). Conclusions and relevance: This analysis suggests that a higher pain level at presentation was associated with a higher risk of initial failure of nonoperative management and that a longer duration of pain was associated with lower risk of delayed treatment failure. Although satisfaction was high in both groups, satisfaction with the treatment decision was higher among patients with successful nonoperative management at 1 year.Item Impact of Level of Effort on the Effects of Compliance with the 3-Hour Rule(Elsevier, 2019) Beaulieu, Cynthia L.; Peng, Juan; Hade, Erinn M.; Corrigan, John D.; Seel, Ronald T.; Dijkers, Marcel P.; Hammond, Flora M.; Horn, Susan D.; Timpson, Misti L.; Swan, Melanie; Bogner, Jennifer; Physical Medicine and Rehabilitation, School of MedicineObjective To determine if patients’ level of effort (LOE) in therapy sessions during traumatic brain injury (TBI) rehabilitation modifies the effect of compliance with the 3-Hour Rule of the Centers for Medicare & Medicaid Services. Design Propensity score methodology applied to the TBI-Practice-Based Evidence (TBI-PBE) database, consisting of multi-site, prospective, longitudinal observational data. Setting Acute inpatient rehabilitation facilities (IRF). Participants Patients (n=1820) who received their first IRF admission for TBI in the US and were enrolled for 3 and 9 month follow-up. Main Outcome Measures Participation Assessment with Recombined Tools-Objective-17, FIMTM Motor and Cognitive scores, Satisfaction with Life Scale, and Patient Health Questionnaire-9. Results When the full cohort was examined, no strong main effect of compliance with the 3-Hour Rule was identified and LOE did not modify the effect of compliance with the 3-Hour Rule. In contrast, LOE had a strong positive main effect on all outcomes, except depression. When the sample was stratified by level of disability, LOE modified the effect of compliance, particularly on the outcomes of participants with less severe disability. For these patients, providing 3 hours of therapy for 50%+ of therapy days in the context of low effort resulted in poorer performance on select outcome measures at discharge and up to 9 months post discharge compared to patients with <50% of 3-hr therapy days. Conclusions LOE is an active ingredient in inpatient TBI rehabilitation, while compliance with the 3-Hour Rule was not found to have a substantive impact on the outcomes. The results support matching time in therapy during acute TBI rehabilitation to patients’ LOE in order to optimize long-term benefits on outcomes.Item Multi-institutional trial of non-operative management and surgery for uncomplicated appendicitis in children: Design and rationale(Elsevier, 2019-08-01) Minneci, Peter C.; Hade, Erinn M.; Lawrence, Amy E.; Saito, Jacqueline M.; Mak, Grace Z.; Hirschl, Ronald B.; Gadepalli, Samir; Helmrath, Michael A.; Leys, Charles M.; Sato, Thomas T.; Lal, Dave R.; Landman, Matthew P.; Kabre, Rashmi; Fallat, Mary E.; Fischer, Beth A.; Cooper, Jennifer N.; Deans, Katherine J.; Surgery, School of MedicineTraditionally, children presenting with appendicitis are referred for urgent appendectomy. Recent improvements in the quality and availability of diagnostic imaging allow for better pre-operative characterization of appendicitis, including severity of inflammation; size of the appendix; and presence of extra-luminal inflammation, phlegmon, or abscess. These imaging advances, in conjunction with the availability of broad spectrum oral antibiotics, allow for the identification of a subset of patients with uncomplicated appendicitis that can be successfully treated with antibiotics alone. Recent studies demonstrated that antibiotics alone are a safe and efficacious treatment alternative for patents with uncomplicated appendicitis. The objective of this study is to perform a multi-institutional trial to examine the effectiveness of non-operative management of uncomplicated pediatric appendicitis across a group of large children’s hospitals. A prospective patient choice design was chosen to compare non-operative management to surgery in order to assess effectiveness in a broad population representative of clinical practice in which non-operative management is offered as an alternative to surgery. The risks and benefits of each treatment are very different and a “successful” treatment depends on which risks and benefits are most important to each patient and his/her family. The patient-choice design allows for alignment of preferences with treatment. Patients meeting eligibility criteria are offered a choice of non-operative management or appendectomy. Primary outcomes include determining the success rate of non-operative management and comparing differences in disability days, and secondarily, complication rates, quality of life, and healthcare satisfaction, between patients choosing non-operative management and those choosing appendectomy.