Historical Control Analysis Research Articles

Liberal surgical laparoscopy reduction for acute intussusception: experience from a tertiary pediatric institute

The optimal treatment for acute intussusception has not yet been defined. In this study, we explored whether employing a liberal laparoscopic intervention for intussusception could lead to favorable outcomes. We performed a historical control analysis to evaluate the outcomes associated with this liberal surgical management protocol. This liberal surgical management protocol were revised to incorporate a new protocol centered around the laparoscopic approach. In some cases of acute intussusception, liberal laparoscopic exploration and intervention were undertaken without initial hydrostatic or pneumatic reduction. During the study interval, a retrospective review was conducted on a total of 3086 patients. These were categorized into two groups: 1338 cases before May 2019 (pre-protocol group) and 1748 cases after May 2019 (post-protocol group). Surgical intervention rates in the pre-protoco and post-protocol period were 10.2% and 27.4% respectively (odds ratio [OR] = 0.30 [95% CI 0.25–0.37]; p < 0.001). No significant differences were observed in baseline clinical characteristics or demographic features between the two groups. The duration from admission to operation was longer for the pre-protocol group (p = 0.008) than for the post-protocol group. The post-protocol group demonstrated decreases in both intestinal resection (OR = 1.50 [95% CI 0.96–2.35]; p = 0.048) and total recurrent events (OR = 1.27 [95% CI 1.04–1.55]; p = 0.012) compared to the pre-protocol group. Liberal laparoscopic intervention for intussusception may effectively reduce the risk of intestinal resection and total recurrent events, thereby exhibiting promising outcomes for patients with intussusception.

Strict Surgical Repair for Bile Leakage Following the Roux-en-Y Hepaticojejunostomy.

Background: The optimal bile leakage management strategy in the pediatric population following the initial Roux-en-Y hepaticojejunostomy is still a matter of discussion today. Here, we assessed the roles of bile leakage management and surgical implementation on outcomes for patients with bile leakage.Materials and Methods: A revised protocol for bile leakage management with restricted surgical intervention was implemented at Chongqing Children’s Hospital on March 15, 2013 and Sanxia Hospital on April 20, 2013. We performed a retrospective, historical control analysis for the protocol implementation to compare the short- and long-term outcomes using the corresponding statistical methods.Results: There was a total of 84 patients included in the analysis, including 46 patients in the pre-protocol group and 38 patients in the post-protocol group. No statistical differences for the demographic features were found between the two groups. There was a decrease in redo surgeries in the post-protocol cohort compared to those in the pre-protocol cohort (odds ratio [OR] = 4.48 [95% CI, 1.57–12.77]; p = 0.003). Furthermore, patients in the post-protocol group were less likely to be associated with intensive care unit (ICU) admission (OR = 3.72 [95% CI, 1.11–12.49]; p = 0.024) compared to patients in the pre-protocol group, respectively. There was no mortality between the two groups.Conclusions: A restrictive surgical intervention strategy can effectively reduce the rate of redo surgery and exhibited promising outcomes for bile leakage in terms of postoperative recovery and hospitalization costs.

Cost-utility analysis of pralatrexate for relapsed or refractory peripheral T-cell lymphoma based on a case-matched historical control study along with single arm clinical trial

BackgroundPatients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) treated with pralatrexate have previously shown superior overall survival (OS) compared to those who underwent conventional chemotherapy (CC, 15.4 vs. 4.07 months). We conducted an economic evaluation of pralatrexate from a societal perspective in Korea based on data from the PROPEL phase II study.MethodsUsing a Markov model with a weekly cycle, we simulated the experience of patients with R/R PTCL receiving pralatrexate or CC for 15 years. The model consists of five health states; initial treatment, treatment pause, subsequent treatment, stem cell transplantation (SCT) success, and death. Comparative effectiveness was based on PROPEL phase II single-arm study and its matched historical control analysis. Costs included drug, drug administration, monitoring, adverse event management, and SCT costs.ResultsThe incremental cost-effectiveness ratio of the base case was $39,153 per quality-adjusted life-year (QALY) gained. The results of one-way sensitivity analysis ranged from $33,949 to $51,846 per QALY gained, which remained within an implicit willingness-to-pay (WTP) threshold of anticancer drugs in Korea.ConclusionsPralatrexate is a cost-effective intervention with improved OS and incremental costs within the WTP limit. Pralatrexate could function as a new therapeutic option for patients suffering from life-threatening R/R PTCL.

Impact of Real-Time Clinical Decision Support on Blood Utilization and Outcomes in Hospitalized Patients with Solid Tumor Cancer

Patients with cancer are frequently hospitalized, and anemia is a common complication of cancer care. Transfusion is often required and commonly occurs above guideline-supported thresholds. It was hypothesized that an educational intervention, combined with real-time clinical decision support (CDS), would reduce blood utilization among hospitalized solid tumor cancer patients without adversely affecting outcomes. A retrospective, historical control analysis was conducted comparing transfusion utilization among hospitalized solid tumor cancer patients before and after implementation of the educational intervention and CDS. The primary outcome was receipt of red blood cell (RBC) transfusion. Secondary outcomes included total RBC transfusions per 100 inpatient-days, readmission, outpatient transfusion within seven days of discharge, inpatient mortality, and odds of transfer to the ICU. The odds of receiving a transfusion were significantly reduced in the postintervention cohort (odds ratio [OR] = 0.52, p = 0.005). Among patients receiving transfusion, there was no significant difference between groups in the number of RBC transfusions per 100 inpatient-days (incidence rate ratio = 0.87, p = 0.26). There were also no significant differences in readmission, outpatient transfusion within seven days of discharge, or inpatient mortality, though patients in the postintervention cohort had lower odds of ICU transfer (OR = 0.29, p = 0.04). The combined use of an educational intervention and CDS in a hospitalized solid tumor cancer patient population was associated with lower blood utilization, similar patient outcomes, and unchanged short-term outpatient transfusion requirements. Hospitals should consider similar interventions to work toward appropriate resource allocation and mitigation of transfusion-associated risk in this patient population.

Impact of a best practice alert on transfusion practices for solid tumor oncology patients.

57 Background: Recent evidence supports a restrictive transfusion strategy in the majority of hospitalized patients, though transfusion practices for oncology patients remain highly variable. We evaluated whether use of a best practice alert for solid tumor oncology inpatients would result in more restrictive transfusion practices and impact patient outcomes. Methods: We conducted a retrospective, historical control analysis at a large academic hospital in Chicago, IL. We compared transfusion utilization among solid tumor oncology patients before and after implementation of a transfusion alert. Patients with active bleeding, hematologic malignancies and those undergoing surgical procedures were excluded. A best practice alert with clinical decision support encouraging use of a restrictive transfusion strategy (Hgb &lt; 7 g/dL) was implemented 6/14 with phase-in completed by 9/14. We abstracted PRE intervention medical records of patients hospitalized from 5/1/13 to 4/30/14 and POST intervention records from 9/1/14 to 8/31/15. Readmission rates, incidence of ICU transfer and inpatient mortality were also compared using multiple linear regression. Outcomes were adjusted for age, gender, race, BMI, smoking status and Charlson comorbidity index. Results: 1296 total patients were included in the analysis (PRE, n = 685; POST, n = 611). There were no differences in age, gender, BMI or Charlson comorbidity index among cohorts, although the PRE cohort included more Caucasians (60.2% vs. 46.8%, p &lt; 0.0001) and smokers (6.0% vs. 2.5%, p = 0.002). Packed red blood cells transfused per 100 patient-days were significantly lower in the POST-intervention cohort (3.8 vs. 6.4, p = 0.01). The POST-intervention cohort also had fewer 30-day emergency department visits (3.3% vs. 5.1%, p = 0.03). There were no significant differences in rates of 30-day readmission (34.6 % vs. 37.3%, p = 0.19), ICU transfer (0.5% vs. 1.1%, p = 0.08) or inpatient mortality (1.7% vs. 1.8%, p = 0.96). Conclusions: Implementation of a best practice alert among solid tumor oncology patients effectively reduced utilization of packed red blood cells without affecting patient outcomes.

Successful Implementation of a Packed Red Blood Cell and Fresh Frozen Plasma Transfusion Protocol in the Surgical Intensive Care Unit

BackgroundBlood product transfusions are associated with increased morbidity and mortality. The purpose of this study was to determine if implementation of a restrictive protocol for packed red blood cell (PRBC) and fresh frozen plasma (FFP) transfusion safely reduces blood product utilization and costs in a surgical intensive care unit (SICU).Study DesignWe performed a retrospective, historical control analysis comparing before (PRE) and after (POST) implementation of a restrictive PRBC/FFP transfusion protocol for SICU patients. Univariate analysis was utilized to compare patient demographics and blood product transfusion totals between the PRE and POST cohorts. Multivariate logistic regression models were developed to determine if implementation of the restrictive transfusion protocol is an independent predictor of adverse outcomes after controlling for age, illness severity, and total blood products received.Results829 total patients were included in the analysis (PRE, n=372; POST, n=457). Despite higher mean age (56 vs. 52 years, p=0.01) and APACHE II scores (12.5 vs. 11.2, p=0.006), mean units transfused per patient were lower for both packed red blood cells (0.7 vs. 1.2, p=0.03) and fresh frozen plasma (0.3 vs. 1.2, p=0.007) in the POST compared to the PRE cohort, respectively. There was no difference in inpatient mortality between the PRE and POST cohorts (7.5% vs. 9.2%, p=0.39). There was a decreased risk of urinary tract infections (OR 0.47, 95%CI 0.28-0.80) in the POST cohort after controlling for age, illness severity and amount of blood products transfused.ConclusionsImplementation of a restrictive transfusion protocol can effectively reduce blood product utilization in critically ill surgical patients with no increase in morbidity or mortality.

Contraceptive efficacy, safety, fit, and acceptability of a single-size diaphragm developed with end-user input.

To estimate contraceptive efficacy, safety, acceptability, and fit of a single-size diaphragm used with contraceptive gel. We conducted a multicenter trial in which 450 couples used the single-size diaphragm, 300 randomized to acid-buffering gel and 150 to nonoxynol-9, for at least 190 days and six menstrual cycles. Visits were at enrollment and after menstrual cycles 1, 3, and 6. Study outcomes included pregnancy probability, safety, acceptability, and fit. Pregnancy and safety were compared with an historical control group who used a standard diaphragm with these gels. Most (439/450 [98%]) women could be fitted with the single-size diaphragm. A total of 421 of 450 (94%) provided follow-up. The 35 study pregnancies yielded 6-month Kaplan-Meier cumulative typical use pregnancy probabilities per 100 women with 95% confidence intervals (CIs) of 10.4 (6.9-14.0) for all users and 9.6 (5.5-13.6) and 12.5 (5.4-19.5) with acid-buffering gel and nonoxynol-9, respectively. Historical control analysis yielded a propensity score-adjusted estimate of this pregnancy probability for the single-size diaphragm of 11.3 compared with 10.7 per 100 women for the standard diaphragm ([rounded] difference 0.7, 95% CI -3.6 to 4.9). Approximately half (51%) reported at least one urogenital event but compared favorably to the standard diaphragm in historical control analysis. Most (282/342 [82%]) liked the diaphragm. Results suggest that if provided by a clinician, 94% (95% CI 92-96%) could insert, correctly position, and remove the diaphragm. The single-size diaphragm was safe, as effective as a standard diaphragm, and acceptable when used with contraceptive gel. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00578877.

Lamotrigine XR conversion to monotherapy: first study using a historical control group.

The efficacy and safety of lamotrigine extended-release tablets (LTG XR) as monotherapy for partial seizures were evaluated using the conversion-to-monotherapy design, and historical data as the control. This methodology was recently approved by the United States Food and Drug Administration, and this study is the first historical control design in epilepsy to complete enrollment. Patients ≥13 years old with uncontrolled partial epilepsy receiving monotherapy with valproate or a noninducing antiepileptic drug were converted to once-daily LTG XR (250 mg or 300 mg) as monotherapy and were followed up for 12 additional weeks. Efficacy was measured by the proportion of patients meeting predefined escape criteria for seizure worsening compared with aggregated pseudoplacebo control data from 8 previously conducted conversion-to-monotherapy trials. Nonoverlap of the 95% confidence limit for LTG XR and the 95% prediction interval of the historical control denotes efficacy. Of 226 randomized patients, 174 (93 in 300 mg/day group and 81 in 250 mg/day group) started withdrawal of the background AED and were evaluated for escape. In the historical control analysis population, the lower 95% prediction interval of the historical control (65.3%) was not overlapped by the upper 95% confidence limit of either LTG XR (300 mg/day; 37.2%) or LTG XR (250 mg/day; 43.4%). Adverse events were reported in 53% and 61% of patients receiving LTG XR (300 mg/day and 250 mg/day, respectively). LTG XR (250 mg or 300 mg once daily) is effective for conversion-to-monotherapy treatment of partial seizures in patients ≥13 years old.

A Retrospective Analysis of Concurrent CRT in HNSCC Cases using Low Doses of CDDP: Efficacy of Combination with Hybrid Type AHF only Indicated during Chemotherapy

To evaluate long term results on survival, locoregional control and larynx preservation in the patients with operable Stage III–IV laryngopharyngeal Ca mainly, who had been treated with low-dose of CDDP regimen. To evaluate an altered fractionated RT regimen in which AHF was indicated only during 2 cycles of chemotherapy, which was introduced in order to intensify RT more than conventional schedule. Since April 1992 to March 2007, 102 cases with loco- regional advanced but operable laryngopharyngeal SCC has been consecutively treated with 2 cycles of chemotherapy, Chemotherapy regimen was 20mg/m2 4 times a week of CDDP or CDGP. CDGP was administered in patients with low renal function (CCr24<70ml/min) or adverse effects after first course of CDDP. Since April 1999, 71 patients has been consecutively enrolled to the hybrid type AHF regimen which was indicated in only chemotherapy weeks. 1.5 Gy/F b.i.d. 4 days a week was administered in first and 5th week of total 6.5 weeks RT schedule. They were compared with another group of 31 cases treated in 7.5 weeks conventional schedule before the altered fractionation regimen started. Prescribed doses of hybrid type AHF and conventional schedule were 68 Gy/36F/6.5 weeks and 68.2 Gy/31F/7.5 weeks, respectively. The BED at α/β=10 for each them were 56.5 and 58.7, respectively, and at α/β=3 they were 104.6 and 118.2, respectively. As primary site distribution was unbalanced between two groups, we also analyzed for primary adjusted 73 cases with oropharynx T4 limited, hypopharynx, and larynx. Finally the distribution became 1: 22: 8 in the former and 2: 30: 10 in the latter. The Stage distribution on Stage II: III: IVA was 5: 14: 12 in the former and 6: 14: 22 in the latter, respectively, in the 73 cases. Median observation time was 92 months in the conventional group and 35 months in the hybrid AHF group. Eighteen cases of all had experienced double cancer and 2 cases triple. Five-year CSS was 80.6% in the former, 90.2% in the latter. Definitive RT were done in 94 cases of all. In primary adjustment study 5-year CSS was 80.6% in the conventional group, and 89.2% in the hybrid type AHF (p = 0.235), 5-year locoregional RFS was 86.3% and 86.7%, respectively. And 5-year larynx preservation rate was 73.3% and 92.7%, respectively. There was significant difference between two groups (p = 0.028) only in the larynx preservation rate. We have experienced CRT using low dose CDDP/CDGP for 102 cases with locally advanced but operable HNSCC for 15 years. From this historical control analysis we estimate that CRT combination with hybrid type AHF would make functional preservation easier than CRT in conventional schedule in operable HNSCC. We should make a plan for the RCS on this issue as soon as we can.

Structured emergency medicine board review and resident in-service examination scores.

To determine whether the institution of a structured board review program is associated with improved in-service examination scores by residents at an emergency medicine (EM) residency program. A retrospective, historical control analysis of the association of a board review program and in-service examination scores at one EM residency program was performed. A structured board review consisting of monthly reading assignments in "classic" EM textbooks followed by a graded multiple-choice written examination was instituted in 1987. Percentile scores on the American Board of Emergency Medicine (ABEM) in-service examination before (1985-1986) and after (1987-1994) initiation of the board review process were compared by resident level (EM-1, 2, or 3). The EM-1 mean percentile score before review was 50.7 and rose to 68.9 after the institution of the board review program (p = 0.039). Mean EM-2 scores (66.8 vs 65.4) and EM-3 scores (74.4 vs 67.4) decreased slightly; these decreases were not statistically significant. Due to the large increase in EM-1 scores, the mean scores for the total program increased slightly (63.4 vs 67.4; p = NS). In this study, EM-1 in-service scores improved in association with the institution of a structured board review program. This formalized didactic program may increase the knowledge base and test performance of EM-1 residents. A favorable effect on EM-2 and EM-3 resident scores was not seen.