Category: Statistics

Sci Rep. 2023 Feb 7;13(1):2194. doi: 10.1038/s41598-023-28697-8.

ABSTRACT

The COVID-19 Vaccines Global Access (COVAX) is a World Health Organization (WHO) initiative that aims for an equitable access of COVID-19 vaccines. Despite potential heterogeneous infection levels across a country, countries receiving allotments of vaccines may follow WHO’s allocation guidelines and distribute vaccines based on a jurisdictions’ relative population size. Utilizing economic-epidemiological modeling, we benchmark the performance of this pro rata allocation rule by comparing it to an optimal one that minimizes the economic damages and expenditures over time, including a penalty representing the social costs of deviating from the pro rata strategy. The pro rata rule performs better when the duration of naturally- and vaccine-acquired immunity is short, when there is population mixing, when the supply of vaccine is high, and when there is minimal heterogeneity in demographics. Despite behavioral and epidemiological uncertainty diminishing the performance of the optimal allocation, it generally outperforms the pro rata vaccine distribution rule.

PMID:36750592 | DOI:10.1038/s41598-023-28697-8

Eye (Lond). 2023 Feb 7. doi: 10.1038/s41433-023-02421-2. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine the baseline risk factors for elective ophthalmic surgery cancellations and characterise the reasons for cancellation.

METHODS: This is a retrospective, non-randomised study performed at a large tertiary ophthalmic centre. It included a consecutive sample of patients above the age of 18 who had an ophthalmic surgery scheduled at Cole Eye Institute, Cleveland Clinic, OH between January 2012 and December 2019. An automated search pull identified 75,908 scheduled surgeries (63,987 completed and 11,921 cancelled surgeries). Statistical analysis was performed using R (version 3.5.1). Main outcome measures were baseline factors that impact risk for surgery cancellation and reasons for surgery cancellation.

RESULTS: Analysis was performed on 69,963 scheduled surgeries (57.37% Female, 42.63% Male; Mean age of 62.72 years; 59,959 completed and 10,004 cancelled surgeries). Of the 2384 cancelled surgeries with reasons provided, the most common causes of cancellation were patient refusal (38.42%), patient health condition (18.79%), and rescheduling of surgery (15.27%). Female sex, black race, patient age less than 50 years, non-cataract surgeries, regional mean household income greater than $82,900, Medicare insurance, and geographical distance of less than 10 miles from home to the surgery site were each associated with a significantly increased risk of surgery cancellation (p < 0.01).

CONCLUSIONS: This study successfully identified several baseline factors predicting elective ophthalmic surgery cancellation. The clinical insights gained from these lines of enquiry may be used to construct models that not only identify patients at greater risk for cancellation but also highlight which interventions have greatest efficacy in preventing ophthalmic surgery cancellations.

PMID:36750587 | DOI:10.1038/s41433-023-02421-2

Spine Deform. 2023 Feb 7. doi: 10.1007/s43390-023-00659-0. Online ahead of print.

ABSTRACT

PURPOSE: The aim of the present study was to evaluate the effectiveness of carbon nanotubes (CNTs)/ HA-tricalcium phosphate (TCP) composite in a posterolateral spinal fusion model.

METHODS: At first, CNTs and CNTs/HA-TCP composites were prepared. Twenty adult male Sprague Dawley rats were randomized into four groups with five rats in each group. Decortication was carried out in standard manner in all animals. Group 1 (only decortication), group 2 (CNTs), group 3 (HA-TCP) and group 4 (CNTs/HA-TCP) were formed. Eight weeks later, all animals were killed and obtained fusion segments were evaluated by manual palpation, histomorphometry and micro-computed tomography (mCT).

RESULTS: In all evaluations, highest fusion values were obtained in Group 4. In mCT investigations, bone volume/ tissue volume (BV/TV) ratio was found to be significantly higher in composite group (group 4) only compared to ceramic group (group 3) (p < 0.001). Although in Group 2, in which only CNTs were used, the ratio was found to be statistically significantly higher than group 1(p < 0.001), the difference was not considered as significant in terms of fusion and in addition in group 2, CNTs were completely surrounded by fibrous tissue, i.e., no bone formation was observed.

CONCLUSIONS: The CNTs/HA-TCP composite is a promising synthetic bone graft substitute for spinal fusion. Although CNTs are inadequate in producing spinal fusion when they are used alone, due to their high biocompatibility due to their high biocompatibility, and multiple effect on bone regeneration, they seem to increase fusion rates significantly when they are used in combination with ceramic-based synthetic grafts.

PMID:36750546 | DOI:10.1007/s43390-023-00659-0

Adv Ther. 2023 Feb 7. doi: 10.1007/s12325-023-02438-9. Online ahead of print.

ABSTRACT

INTRODUCTION: In the absence of head-to-head trials, this study compared treatment outcomes with the C3 complement inhibitor pegcetacoplan versus the C5 complement inhibitor eculizumab or ravulizumab in complement inhibitor-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH).

METHODS: A matching-adjusted indirect comparison was conducted using individual patient data from the pegcetacoplan arm of the PRINCE trial (NCT04085601; n = 34) and aggregate data from the ravulizumab (n = 125) and eculizumab (n = 121) arms of the ALXN1210-PNH-301 trial (NCT03056040). Clinical and quality of life endpoints were evaluated after matching patients in the two trials on baseline characteristics. The weighted Wald test with 95% confidence interval was used to compare categorical and continuous variables (i.e., weighted chi-squared and z tests, respectively). Bias factor analysis was performed to quantify the extent of residual bias from unmeasured confounders.

RESULTS: After weighting, treatment with pegcetacoplan was associated with statistically significant improvements in most clinical endpoints compared with ravulizumab or eculizumab treatment. These included: greater absolute and percent reductions in lactate dehydrogenase (LDH) level and increase in hemoglobin level from baseline; shorter time to first occurrence of LDH normalization; larger proportions of patients achieving hemoglobin stabilization and avoiding transfusion, with fewer packed red blood cell units transfused; and a smaller proportion of patients experiencing breakthrough hemolysis (all p < 0.05). Patients receiving pegcetacoplan also had a greater increase in general health status score from baseline compared with those receiving C5 complement inhibitors.

CONCLUSION: Pegcetacoplan provides clinical benefits as first-line treatment for complement inhibitor-naïve patients with PNH.

TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04085601.

PMID:36750531 | DOI:10.1007/s12325-023-02438-9

Hum Nat. 2023 Feb 8. doi: 10.1007/s12110-023-09440-8. Online ahead of print.

ABSTRACT

Support from grandparents plays a role in mothers’ perinatal mental health. However, previous research on maternal mental health has mainly focused on influences of partner support or general social support and neglected the roles of grandparents. In this narrative review and meta-analysis, the scientific evidence on the association between grandparental support and maternal perinatal mental health is reviewed. Searches in PubMed, EMBASE, MEDLINE, Scopus, and PsycINFO yielded 11 empirical studies on N = 3381 participants, reporting on 35 effect sizes. A multilevel approach to meta-analysis was applied to test the association between grandparental support and maternal mental health. The results showed a small, statistically significant association (r = .16; 95% CI: 0.09-0.25). A moderator test indicated that the association was stronger for studies reporting on support from the maternal grandmother in particular (r = .23; 95% CI: 0.06-0.29). Our findings suggest that involved grandparents, in particular mother’s own mother, constitute a protective factor for the development of maternal postpartum mental health problems. These findings have clear implications for interventions. Future studies should examine whether stimulating high-quality support from grandparents is a fruitful avenue for enhancing maternal postpartum mental health.

PMID:36750511 | DOI:10.1007/s12110-023-09440-8

Ann Hematol. 2023 Feb 7. doi: 10.1007/s00277-023-05122-8. Online ahead of print.

ABSTRACT

Severe bleeding is the leading cause of early death in patients with newly diagnosed acute promyelocytic leukemia (APL). However, there are no means for hemorrhagic risk stratification in APL. This study aimed to identify optimized predictors of severe bleeding events related to APL. A total of 109 consecutive patients with newly diagnosed APL from January 2015 to April 2022 were retrospectively investigated. A systematic review of computer-based patient medical records was conducted to obtain clinical date, including baseline characteristics, routine blood examination findings, coagulation and fibrinolysis indexes, and bleeding events. Among the 109 patients, 89 were classified into the no-severe bleeding group, while 20 had severe bleeding. Compared with the patients with no severe bleeding, the patients with severe bleeding had significantly higher circulating leukemic cell percentages, disseminated intravascular coagulation (DIC) scores, D-dimer (D-D) levels, and fibrin degradation product (FDP) levels. They also had lower fibrinogen (FIB) levels and a longer prothrombin time. Multivariate analysis revealed that the circulating leukemic cell percentage (OR = 1.040, CI = 1.008-1.072, P = 0.012), FIB level (OR = 0.101, CI = 0.011-0.896, P = 0.040), and FDP level (OR = 1.012, CI = 1.000-1.024, P = 0.047) were independent risk factors for severe bleeding. FDP/FIB, D-D/FIB, and seven meaningful indicators in the single-factor analysis were included in the receiver operating characteristic (ROC) curve analysis. The results showed that FDP/FIB was the best indicator for predicting severe bleeding related to newly diagnosed APL. The area under the ROC curve of FDP/FIB was 0.915, and the best cutoff value was 61.77, with 100% sensitivity and 74.2% specificity. Statistical analysis showed a higher incidence of severe bleeding and higher DIC scores when FDP/FIB was >61.77 in APL patients. FDP/FIB has obvious advantages in predicting the degree of bleeding associated with primary promyelocytic leukemia; the greater the FDP/FIB value, the more severe the bleeding. The risk of severe bleeding was the highest when FDP/FIB > 61.77.

PMID:36750485 | DOI:10.1007/s00277-023-05122-8

Ann Dermatol. 2023 Feb;35(1):38-45. doi: 10.5021/ad.22.118.

ABSTRACT

BACKGROUND: Atopic dermatitis (AD) patients usually wonder if their condition will worsen after vaccination or if they should continue with the treatment they are receiving. Considering that many patients treated with dupilumab had previously experienced severe AD symptoms and flares, the concerns are more understandable.

OBJECTIVE: This study aimed to investigate the safety of the coronavirus disease 2019 (COVID-19) vaccination in patients with AD treated with dupilumab.

METHODS: We enrolled 133 patients (101 dupilumab-treated and 32 systemic oral agents-treated as control group) with AD from six hospitals. Patients were asked about worsening pruritus and AD (5-point Likert scale) after vaccination. AD variables (eczema area and severity index [EASI], investigator’s global assessment [IGA], itch numerical rating scale [NRS], sleep NRS, and patient-oriented eczema measure [POEM]) were compared pre- and post-vaccination. Adverse reactions to the COVID-19 vaccination were observed.

RESULTS: The incidence of adverse reactions to COVID-19 vaccines and worsening AD symptoms in dupilumab-treated patients were not significantly different compared with that in the control group. The itch NRS score increased significantly after vaccination (p<0.001). However, there were no statistically significant differences between the pre-and post-EASI, IGA, and POEM scores. Eight patients (7.9%) had worse EASI scores and required rescue therapy; however, most were easily managed with low-dose steroids or topical agents. None of the patients discontinued dupilumab treatment.

CONCLUSION: No serious adverse reactions were observed in patients with AD after COVID-19 vaccination. Exacerbation of pruritus and AD symptoms was observed but was mostly mild and transient.

PMID:36750457 | DOI:10.5021/ad.22.118

Clin Spine Surg. 2023 Feb 3. doi: 10.1097/BSD.0000000000001436. Online ahead of print.

ABSTRACT

STUDY DESIGN: Retrospective cohort study.

OBJECTIVE: We aim to investigate the relationship between the intraoperative motor evoked potential (MEP) signal changes during surgical treatment of cervical myelopathy with postoperative functional outcomes and determine what factors correlate with MEP signal changes.

SUMMARY OF BACKGROUND DATA: Intraoperative neurophysiologic monitoring with MEP for cervical cord decompression can potentially predict postoperative neurological complications.

MATERIALS AND METHODS: We prospectively collected data from 114 consecutive cervical compressive myelopathy patients who underwent decompressive cervical spine surgery. Functional outcomes were measured preoperatively and postoperatively at the 6-month mark, using the modified Japanese Orthopedic Association score.

RESULTS: Among the 114 patients, 87 patients showed significant MEP improvement, 1 patient with MEP degeneration, 3 patients with no change in MEP, and 23 patients with MEP change, but which eventually returned to baseline. Univariate analysis showed that patients with MEP improvement had similar 6-month functional and Japanese Orthopedic Association scores compared with patients who did not have MEP improvement. Critically, a longer duration of symptoms was shown to have a statistically significant relationship with patients who did not have MEP improvement on univariate analysis (49.2 wk in patients with no MEP improvement compared with 34.59 wk in patients with MEP improvement, P = 0.03) but this did not translate to differences in functional outcomes. There was also no statistically significant association between the functional outcome scores and demographics, surgical, or radiologic factors.

CONCLUSIONS: Our study shows that the duration of symptoms is not attributed to lower functional outcomes but is associated with a lack of MEP improvement.

LEVEL OF EVIDENCE: Level III.

PMID:36750440 | DOI:10.1097/BSD.0000000000001436

J Hand Surg Am. 2023 Feb 5:S0363-5023(22)00722-5. doi: 10.1016/j.jhsa.2022.11.020. Online ahead of print.

ABSTRACT

PURPOSE: Although carpal tunnel syndrome (CTS) can be diagnosed clinically with the Carpal Tunnel Syndrome 6 (CTS-6) evaluation tool, the relationship between disease severity and CTS-6 score has not been elucidated. The purpose of our study was to determine the correlation of the CTS-6 score and other physical examination maneuvers with the carpal tunnel severity grade by electrodiagnostic testing (EDT). We hypothesized that the CTS-6 score, Durkan test, and Semmes Weinstein Monofilament Testing (SWMT) positively correlate with EDT severity.

METHODS: We prospectively enrolled 105 consecutive patients who presented to the office with suspected CTS, excluding those with previous surgery, previous EDT from an outside facility, or concomitant neuropathy. Four fellowship-trained hand surgeons obtained the CTS-6 score, time to obtain a positive Durkan compression test, and SWMT of the thumb, index, and middle fingers. All patients were sent for EDT. Hand surgeons were blinded to the results of the EDT, and the electrodiagnosticians were blinded to the clinical data. We used the Bland criteria (0-6) to grade CTS severity on EDT. This grade was compared with the CTS-6 score, Durkan time, and SWMT results.

RESULTS: Using Spearman correlation coefficients, we found a weakly positive correlation between a higher CTS-6 score and a higher severity grade on EDT. The mean CTS-6 score based on EDT grading were the following: (1) 14.8 (grade 0), (2) 16.0 (grade 1), (3) 14.8 (grade 2), (4) 16.7 (grade 3), (5) 18.7 (grade 4), (6) 18.3 (grade 5), and (7) 22.4 (grade 6). We also found a statistically significant association between the SWMT and a higher CTS-6 score as well as a higher severity grade on EDT. Durkan compression test did not appear to correlate with the EDT grade.

CONCLUSIONS: The CTS-6 and SWMT show a positive correlation with EDT severity in CTS on the basis of the Bland criteria. The time to a positive Durkan test did not show any correlation.

TYPE OF STUDY/LEVEL OF EVIDENCE/LEVEL OF EVIDENCE: Diagnostic II.

PMID:36750395 | DOI:10.1016/j.jhsa.2022.11.020

Med Dosim. 2023 Feb 6:S0958-3947(23)00013-4. doi: 10.1016/j.meddos.2023.01.003. Online ahead of print.

ABSTRACT

To evaluate the effects of arc geometry on lung stereotactic body radiation therapy (SBRT) plan quality, using collision check software to select safe beam angles. Thirty lung SBRT cases were replanned 10Gy x 5 using 4 volumetric modulated arc therapy (VMAT) geometries: coplanar lateral (cpLAT), coplanar oblique (cpOBL), noncoplanar lateral (ncpLAT) and noncoplanar oblique (ncpOBL). Lateral arcs spanned 180° on the affected side whereas the 180° oblique arcs crossed midline to spare healthy tissues. Couch angles were separated by 30° on noncoplanar plans. Clearance was verified with Radformation CollisionCheck software. Optimization objectives were the same across the four plans for each case. Planning target volume (PTV) coverage was set to 95% and then plans were evaluated for dose conformity, healthy tissue doses, and monitor units. Clinically treated plans were used to benchmark the results. The volumes of the 25%, 50% and 75% isodoses were smaller with noncoplanar than coplanar arcs. The volume of the 50% isodose line relative to the PTV (CI50%) was as follows: clinical 3.75±0.72, cpLAT 3.39 ± 0.37, cpOBL 3.36 ± 0.34, ncpLAT 3.02 ± 0.21 and ncpOBL 3.02 ± 0.22. The Wilcoxon signed rank test with Bonferroni correction showed p < 0.005 in all CI50% comparisons except between the cpLat and cpObl arcs and between the ncpLat and ncpObl arcs. The best lung sparing was achieved using ncpObl arcs, which was statistically significant (p < 0.001) compared with the other four plans at V12.5Gy, V13.5Gy and V20Gy. Chest wall V30Gy was significantly better using noncoplanar arcs in comparison to the other plan types (p < 0.001). The best heart sparing at V10Gy from the ncpOBL arcs was significant compared with the clinical and cpLat plans (p < 0.005). Arc geometry has a substantial effect on lung SBRT plan quality. Noncoplanar arcs were superior to coplanar arcs at compacting the dose distribution at the 25%, 50% and 75% isodose levels, thereby reducing the dose to healthy tissues. Further healthy tissue sparing was achieved using oblique arcs that minimize the pathlength through healthy tissues and avoid organs at risk. The dosimetric advantages of the noncoplanar and oblique arcs require careful beam angle selection during treatment planning to avoid collisions during treatment, which may be facilitated by commercial software.

PMID:36750392 | DOI:10.1016/j.meddos.2023.01.003