Tag: statistics

Vaccine. 2022 Oct 22:S0264-410X(22)01281-6. doi: 10.1016/j.vaccine.2022.10.022. Online ahead of print.

ABSTRACT

BACKGROUND: Human papillomavirus (HPV) infections were the main cause of anogenital cancers and warts. HPV 6/11/16/18 vaccines provide protection against the high-risk types of HPV responsible for 70% of cervical cancers and 90% of genital warts. This randomized, blinded, non-inferiority phase III trial was to determine whether immunogenicity and tolerability would be non-inferior among women after receiving two novel 4- and 9-valent HPV vaccines (4vHPV, HPV 6/11/16/18; 9vHPV, HPV 6/11/16/18/31/33/45/52/58) compared with those receiving Gardasil 4 (4-valent).

METHODS: 1680 females between 20 and 45 years were randomized in a 2:1:1 ratio to 20-26, 27-35, or 36-45 y groups. Subjects then equally assigned to receive 4vHPV, 9vHPV or Gardasil 4 (control) vaccine at months 0, 2, and 6. End points included non-inferiority of HPV-6/11/16/18 antibodies for 4vHPV versus control, and 9vHPV versus control and safety. The immunogenicity non-inferiority was pre-defined as the lower bound of 95% confidence interval (CI) of seroconversion rate (SCR) difference > -10% and the lower bound of 95% CI of geometric mean antibody titer (GMT) ratio > 0.5.

RESULTS: Among the three vaccine groups, more than 99% of the participants seroconverted to all 4 HPV types. The pre-specified statistical non-inferiority criterion for the immunogenicity hypothesis was met: all the lower bounds of 95% CIs on SCR differences exceeded -10% for each vaccine HPV type and the corresponding lower bounds of 95% CIs for GMT ratios > 0.5. Across vaccination groups, the most common vaccination reaction were injection-site adverse events (AEs), including pain, swelling, and redness. General and serious AEs were similar in the three groups. There were no deaths.

CONCLUSIONS: This study demonstrated that the novel 4- and 9-valent HPV vaccination was highly immunogenic and generally well tolerated, both of which were non-inferior to Gardasil 4 in immunogenicity and safety.

PMID:36283897 | DOI:10.1016/j.vaccine.2022.10.022

Injury. 2022 Oct 2:S0020-1383(22)00732-X. doi: 10.1016/j.injury.2022.09.064. Online ahead of print.

ABSTRACT

BACKGROUND: Surgical stabilization of rib fractures (SSRF) is being done with increased frequency and new advances. Intrathoracic SSRF is a new less invasive approach compared to the traditional extrathoracic plating procedure. Educational assessment can be done through descriptive analysis of learning curves with operation time used as a proxy measurement for learning. The objective of this level 3 observational cohort study is to assess the learning curve of introducing the intrathoracic method of plating at a large academic medical institution.

METHODS: Intrathoracic surgical stabilization of rib fractures was introduced at a tertiary trauma center in March of 2019. All patients that received SSRF beginning 11/2017 were included. Patients with abbreviated injury scale score of the head, abdomen, extremity, or face greater than three and days from injury to SSRF greater than 4 were excluded. Operation time was determined from time of incision to completion of skin closure. Time per fracture and time per plate were calculated using total operation time. Learning curves and CUSUM graphs for individual surgeons that had completed in more than 3 SSRF cases were generated using and trended for statistical significance.

RESULTS: After exclusions, there were 38 patients with extrathoracic SSRF between November 2017-September 2021 and 24 patients with intrathoracic plating between March 2019-Sept. 2021. There were 5 fellows and 6 residents that performed extrathoracic SSRF. Four fellows and 2 residents performed intrathoracic SSRF. Graphs of time per fracture and time per plate over time produced learning curves without an inflection point for extrathoracic or intrathoracic SSRF in any of the following categories: all surgeries (Figs. 1 and 2), academic year (July to June), individual attending surgeons, fellows, or residents.

CONCLUSION: There was no discernible inflection point on the generated learning curves. Time per plate and time per fracture did not decrease as surgeons gained more experience. Introducing intrathoracic SSRF in a large academic hospital may not need to account for a learning curve adjustment period.

PMID:36283879 | DOI:10.1016/j.injury.2022.09.064

Br J Anaesth. 2022 Oct 22:S0007-0912(22)00547-5. doi: 10.1016/j.bja.2022.09.012. Online ahead of print.

NO ABSTRACT

PMID:36283871 | DOI:10.1016/j.bja.2022.09.012

J Pediatr Surg. 2022 Sep 26:S0022-3468(22)00614-5. doi: 10.1016/j.jpedsurg.2022.09.032. Online ahead of print.

ABSTRACT

PURPOSE: Intraoperative intercostal nerve cryoablation has emerged as a promising modality for postoperative analgesia following Surgical Correction of Pectus Excavatum (SCOPE). Most centers use two-minute cryoablation per level, although data from histologic and adult studies suggest the effectiveness of one-minute freezes. We aimed to describe our center’s experience with one minute per level cryoablation.

METHODS: A retrospective single institution review of patients undergoing SCOPE was performed to compare patients pre- and post-intercostal nerve cryoablation implementation. Cryoablation was performed as one minute for each of the thoracic intercostal nerves T3-T7. Multivariable regression analyses were conducted to compare the outcomes and cost between pre- and post-implementation groups.

RESULTS: During the study period, 198 patients underwent SCOPE with one Nuss bar, receiving either intraoperative intercostal nerve cryoablation (Cryo, n = 100) or preoperative thoracic paravertebral catheters (NoCryo, n = 98). Surgical time was on average 9 min longer for the Cryo group (p<0.01). Median length of stay for the Cryo group was 3 days shorter compared to the NoCryo group (p<0.01). The Cryo group had a 19-fold and 5.6-fold reduction in average inpatient and total postoperative opioid usage, respectively (p<0.01). Total hospital costs were significantly lower in the Cryo group (p<0.01). Overall complication rate was not statistically significant different between the two groups.

CONCLUSIONS: Intraoperative one minute per level cryoablation is a potent approach to postoperative analgesia for SCOPE patients that led to a shorter hospital length of stay, lower hospital costs, and decreased opioid use compared to conventional analgesia at our institution. Pediatric surgeons performing correction of chest wall deformities should consider offering this technique.

PMID:36283847 | DOI:10.1016/j.jpedsurg.2022.09.032

BMJ Support Palliat Care. 2022 Oct 25:spcare-2022-003924. doi: 10.1136/spcare-2022-003924. Online ahead of print.

ABSTRACT

OBJECTIVES: In lung cancer, three prominent symptoms, such as breathlessness, cough and fatigue, are closely related with each other forming a ‘respiratory distress symptom cluster’. The aim of this study was to determine the clinical and cost-effectiveness of the respiratory distress symptom intervention (RDSI) for the management of this symptom cluster in people with lung cancer.

METHODS: A single blind, pragmatic, randomised controlled trial conducted in eight centres in England, UK. A total of 263 patients with lung cancer were randomised, including 132 who received RDSI and 131 who received standard care. To be eligible, participants self-reported adverse impact in daily life from at least two of the three symptoms, in any combination. Outcomes were change at 12 weeks for each symptom within the cluster, including Dyspnoea-12 (D-12), Manchester Cough in Lung Cancer (MCLC) and Functional Assessment of Chronic Illness-Fatigue.

RESULTS: At baseline, nearly 60% of participants reported all three symptoms. At trial completion the total trial attrition was 109 (41.4%). Compared with the control group, the RDSI group demonstrated a statistically significant improvement in D-12 (p=0.007) and MCLC (p<0.001). The minimal clinically important difference MCID) was achieved for each outcome: D-12 -4.13 (MCID >3), MCLC -5.49 (MCID >3) and FACIT-F 4.91 (MCID >4).

CONCLUSION: RDSI is a clinically effective, low-risk intervention to support the management of the respiratory distress symptom cluster in lung cancer. However, the study did experience high attrition, which needs to be taken onto consideration when interpreting these results.

TRIAL REGISTRATION NUMBER: NCT03223805.

PMID:36283797 | DOI:10.1136/spcare-2022-003924

Curr Pharm Teach Learn. 2022 Oct;14(10):1292-1297. doi: 10.1016/j.cptl.2022.09.009. Epub 2022 Sep 15.

ABSTRACT

INTRODUCTION: Availability of patient care services in rural areas is often lacking, which can reduce access to care for patients living in these areas. Patient care within community pharmacies is vital to care access in rural areas, but expanding pharmacy services can often be challenging. Pharmacy students, especially those on advanced pharmacy practice experiences, are positioned to make an impact on sites.

METHODS: The objective of this study was to describe the implementation, evaluation, and impact of a student scholarship program designed to increase patient care initiatives in rural community pharmacies. Scholarships were provided to students to expand patient care initiatives targeting chronic disease in select rural community pharmacies. Before and after participating in the scholarship program, students completed a survey assessing their perceived ability and confidence to initiate new patient care activities. In addition, patient care services provided by students were tracked and reported cumulatively.

RESULTS: During the first year of implementation, 24 student scholarship rotations were completed. Throughout the 24 rotations, 369 patients were screened for prediabetes, 391 were screened for hypertension, and 552 patients were screened for immunizations. Of the 27 items presented in the survey, 20 items showed a mean statistically significant change indicating an increase in student confidence in leading, developing, and performing patient care activities.

CONCLUSIONS: A student scholarship program designed to increase patient care initiatives in rural community pharmacies led to new patient care services in rural areas and increased student confidence in leading, developing, and expanding upon patient care activities.

PMID:36283796 | DOI:10.1016/j.cptl.2022.09.009

Curr Pharm Teach Learn. 2022 Oct;14(10):1269-1273. doi: 10.1016/j.cptl.2022.09.004. Epub 2022 Sep 15.

ABSTRACT

INTRODUCTION: In many ways, traditional education environments contribute to a sedentary lifestyle, and this can lead to several negative health outcomes. This study determined the extent of anti-sedentary physical activity outcomes resulting from conducting pharmacy academia rotation topic discussions while walking.

METHODS: Topic discussions during six, one-month pharmacy resident academia rotations were converted from a traditional sitting environment to walking discussions conducted at a conversational pace. The preceptor’s time, distance, steps, ascent, and caloric expenditure for the discussions were tracked via the hiking feature on Garmin Fenix 3 Global Positioning System watch (Garmin Ltd.). Results were synced to the Garmin Connect mobile application, from which they were manually transcribed to spreadsheet software. Descriptive statistics for the variables were calculated.

RESULTS: A total of 46 topic discussions were conducted while walking. The average walking topic discussion lasted 44.62 min, covered 2.13 miles with 3896 steps, and expended 159 calories.

CONCLUSIONS: Results of this study demonstrate the various physical activity benefits of conducting topic discussions while walking as opposed to more traditional stationary discussions. Walking topic discussions are a simple way to counteract the sedentary aspects of academia by incorporating physical activity into the educational process without additional time or resources. Opportunity exists for other aspects of academia to adopt similar strategies to benefit faculty, staff, student, and resident wellness.

PMID:36283795 | DOI:10.1016/j.cptl.2022.09.004

Radiology. 2022 Oct 25:212403. doi: 10.1148/radiol.212403. Online ahead of print.

ABSTRACT

Background Pre-liver transplant (LT) sarcopenia is associated with poor survival. Methods exist for measuring body composition with use of CT scans; however, it is unclear which components best predict post-LT outcomes. Purpose To quantify the association between abdominal CT-based body composition measurements and post-LT mortality in a large North American cohort. Materials and Methods This was a retrospective cohort of adult first-time deceased-donor LT recipients from 2009 to 2018 who underwent pre-LT abdominal CT scans, including at the L3 vertebral level, at Johns Hopkins Hospital. Measurements included sarcopenia (skeletal muscle index [SMI] <50 in men and <39 in women), sarcopenic obesity, myosteatosis (skeletal muscle CT attenuation <41 mean HU for body mass index [BMI] <25 and <33 mean HU for BMI ≥25), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and VAT/SAT ratio. Covariates in the adjusted models were selected with use of least absolute shrinkage and selection operator regression with lambda chosen by means of 10-fold cross-validation. Cox proportional hazards models were used to quantify associations with post-LT mortality. Model discrimination was quantified using the Harrell C-statistic. Results A total of 454 recipients (median age, 57 years [IQR, 50-62 years]; 294 men) were evaluated. In the adjusted model, pre-LT sarcopenia was associated with a higher hazard ratio (HR) of post-LT mortality (HR, 1.6 [95% CI: 1.1, 2.4]; C-statistic, 0.64; P = .02). SMI was significantly negatively associated with survival after adjustment for covariates. There was no evidence that myosteatosis was associated with mortality (HR, 1.3 [95% CI: 0.86, 2.1]; C-statistic, 0.64; P = .21). There was no evidence that BMI (HR, 1.2 [95% CI: 0.95, 1.4]), VAT (HR, 1.0 [95% CI: 0.98, 1.1]), SAT (HR, 1.0 [95% CI: 0.97, 1.0]), and VAT/SAT ratio (HR, 1.1 [95% CI: 0.90, 1.4]) were associated with mortality (P = .15-.77). Conclusions Sarcopenia, as assessed on routine pre-liver transplant (LT) abdominal CT scans, was the only factor significantly associated with post-LT mortality. © RSNA, 2022 See also the editorial by Ruehm in this issue.

PMID:36283115 | DOI:10.1148/radiol.212403

Neural Comput. 2022 Oct 14:1-38. doi: 10.1162/neco_a_01547. Online ahead of print.

ABSTRACT

This review examines gradient-based techniques to solve bilevel optimization problems. Bilevel optimization extends the loss minimization framework underlying statistical learning to systems that are implicitly defined through a quantity they minimize. This characterization can be applied to neural networks, optimizers, algorithmic solvers, and even physical systems and allows for greater modeling flexibility compared to the usual explicit definition of such systems. We focus on solving learning problems of this kind through gradient descent, leveraging the toolbox of implicit differentiation and, for the first time applied to this setting, the equilibrium propagation theorem. We present the mathematical foundations behind such methods, introduce the gradient estimation algorithms in detail, and compare the competitive advantages of the different approaches.

PMID:36283053 | DOI:10.1162/neco_a_01547

Neural Comput. 2022 Oct 14:1-35. doi: 10.1162/neco_a_01549. Online ahead of print.

ABSTRACT

Domain adaptation aims to transfer knowledge of labeled instances obtained from a source domain to a target domain to fill the gap between the domains. Most domain adaptation methods assume that the source and target domains have the same dimensionality. Methods that are applicable when the number of features is different in each domain have rarely been studied, especially when no label information is given for the test data obtained from the target domain. In this letter, it is assumed that common features exist in both domains and that extra (new additional) features are observed in the target domain; hence, the dimensionality of the target domain is higher than that of the source domain. To leverage the homogeneity of the common features, the adaptation between these source and target domains is formulated as an optimal transport (OT) problem. In addition, a learning bound in the target domain for the proposed OT-based method is derived. The proposed algorithm is validated using both simulated and real-world data.

PMID:36283052 | DOI:10.1162/neco_a_01549