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Nevin Manimala Statistics

Molecular beacon based real-time PCR p1 gene genotyping, macrolide resistance mutation detection and clinical characteristics analysis of Mycoplasma pneumoniae infections in children

BMC Infect Dis. 2022 Sep 6;22(1):724. doi: 10.1186/s12879-022-07715-6.

ABSTRACT

BACKGROUND: Mycoplasma pneumoniae can be divided into different subtypes on the basis of the sequence differences of adhesive protein P1, but the relationship between different subtypes, macrolide resistance and clinical manifestations are still unclear. In the present study, we established a molecular beacon based real-time polymerase chain reaction (real-time PCR) p1 gene genotyping method, analyzed the macrolide resistance gene mutations and the relationship of clinical characteristics with the genotypes.

METHODS: A molecular beacon based real-time PCR p1 gene genotyping method was established, the mutation sites of macrolide resistance genes were analyzed by PCR and sequenced, and the relationship of clinical characteristics with the genotypes was analyzed.

RESULTS: The detection limit was 1-100 copies/reaction. No cross-reactivity was observed in the two subtypes. In total, samples from 100 patients with positive M. pneumoniae detection results in 2019 and 2021 were genotyped using the beacon based real-time PCR method and P1-1 M. pneumoniae accounted for 69.0%. All the patients had the A2063G mutation in the macrolide resistance related 23S rRNA gene. Novel mutations were also found, which were C2622T, C2150A, C2202G and C2443A mutations. The relationship between p1 gene genotyping and the clinical characteristics were not statistically related.

CONCLUSION: A rapid and easy clinical application molecular beacon based real-time PCR genotyping method targeting the p1 gene was established. A shift from type 1 to type 2 was found and 100.0% macrolide resistance was detected. Our study provided an efficient method for genotyping M. pneumoniae, valuable epidemiological monitoring information and clinical treatment guidance to control high macrolide resistance.

PMID:36068499 | DOI:10.1186/s12879-022-07715-6

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Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: subanalysis of the PROMISE-2 study

J Headache Pain. 2022 Sep 6;23(1):115. doi: 10.1186/s10194-022-01482-0.

ABSTRACT

BACKGROUND: Patients with chronic migraine (CM) treated with eptinezumab in the PROMISE-2 trial achieved greater reductions in migraine and headache frequency, impact, and acute headache medication (AHM) use than did patients who received placebo. This post hoc analysis examines relationships between headache frequency reductions and changes in AHM use in patients in PROMISE-2.

METHODS: PROMISE-2 was a double-blind, placebo-controlled trial conducted in adults with CM. Patients were randomized to eptinezumab 100 mg, 300 mg, or placebo, administered intravenously once every 12 weeks for up to two doses. Patients recorded headache/AHM information daily and for each event in an electronic diary; data from all days with daily reports were included. Shifts in headache frequency and AHM use were assessed in the three populations: total CM population, patients with CM and medication-overuse headache (MOH), and patients with CM and MOH who were ≥ 50% responders during treatment (response over weeks 1-24).

RESULTS: A total of 1072 adults with CM received treatment (eptinezumab, n = 706; placebo, n = 366). Mean baseline headache frequency was 20.5 days; mean baseline AHM days was 13.4; 431 patients had MOH, of which 225 (52.2%) experienced ≥50% response over weeks 1-24. Relative to baseline, the proportion of days with both headache and AHM use decreased 25.1% (eptinezumab) versus 17.0% (placebo) in the total population (N = 1072), 29.2% versus 18.4% in the MOH subpopulation (n = 431), and 38.3% versus 31.5% in the CM with MOH population with ≥50% response subgroup (n = 225) during weeks 1-24. The proportion of days with headache and triptan use decreased 9.1% (eptinezumab) versus 5.8% (placebo), 11.8% versus 7.2%, and 14.5% versus 12.6%, respectively. Reductions in other AHM types were smaller.

CONCLUSIONS: In this post hoc analysis, eptinezumab use in patients with CM was associated with greater decreases in days with headache with AHM overall and with triptans in particular. The magnitude of effect was greater in the subgroup of CM patients with MOH and ≥ 50% response.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02974153 . Eptinezumab reduces headache frequency and acute medication use in patients with chronic migraine.

PMID:36068494 | DOI:10.1186/s10194-022-01482-0

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The effect of different preoperative left atrial appendage emptying speeds on left atrial function in patients with persistent atrial fibrillation after left atrial appendage closure combined with catheter ablation

BMC Cardiovasc Disord. 2022 Sep 6;22(1):399. doi: 10.1186/s12872-022-02842-z.

ABSTRACT

OBJECTIVE: The present study aimed to investigate whether different preoperative left atrial appendage emptying speeds (LAAEVs) have an effect on left atrial function in patients with sinus arrhythmia after left atrial appendage closure (LAAC) combined with catheter ablation (CA).

METHODS: A total of 163 patients with persistent non-valvular atrial fibrillation who received combined LAAC+CA surgery were included in the present study. Regular follow-up was conducted for 12 months, and patients with complete data and successful sinus rhythm recovery were selected as the study subjects (n = 82). The patients were divided into two groups: the LAAEV < 25 cm/s group and the LAAEV ≥ 25 cm/s group (n = 41 each). The propensity score was used for matching according to gender, age, CHA2DS2-VASc score, and HAS-BLED score. The changes in the two groups in LA structure, storage function, conduit function, and pump function were compared.

RESULTS: Before surgery, the maximum LA volume (LAVmax) and minimum LA volume (LAVmin) were greater in the LAAEV < 25 cm/s group than in the LAAEV ≥ 25 cm/s group. The LA storage function (eg. Ƹ and SRs), conduit function (eg. SRe), and pump function (eg. SRa) were all worse in the LAAEV < 25 cm/s group than in the LAAEV ≥ 25 cm/s group. After the combined LAAC+CA surgery, the LA storage, conduit, and pump functions improved in both groups. At 12 months after surgery, there were no statistically significant differences between the two groups.

CONCLUSION: Before combined LAAC+CA surgery, the LA structure and function of the LAAEV < 25 cm/s group were worse than those of the LAAEV ≥ 25 cm/s group. However, after LAAC+CA surgery, the LA structure and function of the patients were improved, and there were no significant differences between the two groups. Inferred improvement in LA structure and function in the LAAEV < 25 cm/s group was superior to that in the LAAEV ≥ 25 cm/s group.

PMID:36068492 | DOI:10.1186/s12872-022-02842-z

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Prednisolone and enoxaparin (clexane) therapy (“the Bondi protocol”) for repeated IVF failure

Am J Reprod Immunol. 2022 Sep 6. doi: 10.1111/aji.13616. Online ahead of print.

ABSTRACT

PROBLEM: What is the impact of an empirical immune therapy protocol of prednisolone and enoxaparin (clexane) (the “Bondi protocol”) on women with repeated IVF failure?

METHOD OF STUDY: This was a retrospective review of live birth outcomes conducted on all transfer cycles performed by a single clinician (GS) at IVFAustralia between February 2016 and April 2020. This consisted of 1786 transfer cycles, including 460 cycles treated with the Bondi protocol and 1326 without. Women with repeated IVF failure were given the Bondi protocol based on blood NK cell activity. Primary outcome was live birth and statistical analysis was performed with GraphPad Prism software with significance for p-values <0.05.

RESULTS: Overall ‘Bondi’ and ‘normal’ protocol cycles had similar rates of IVF/ICSI, fresh/frozen transfers, and use of preimplantation genetic testing (PGT). Women given the Bondi protocol were older, had more previous cycles, and had higher blood NK cell activity. There was no significant difference in live birth rates (Bondi 26%, normal 28%). Bondi protocol live birth rates per transfer cycle were as high as 40% in patients under 38 years old. The Bondi protocol was more effective as NK activity increased from ‘normal’ to ‘borderline’ to ‘high’. For high NK cell activity levels, live birth rates were over 4 times higher for women on the Bondi protocol (28%) than those on normal protocols (6%, p = 0.0007).

CONCLUSIONS: This study describes a simple and relatively safe immune therapy protocol that may improve IVF success rates in women with evidence of immune dysfunction. This article is protected by copyright. All rights reserved.

PMID:36067527 | DOI:10.1111/aji.13616

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Infectious complications and long-term outcomes in patients with diffuse large B-Cell lymphoma and diabetes mellitus

Leuk Lymphoma. 2022 Sep 6:1-7. doi: 10.1080/10428194.2022.2118526. Online ahead of print.

ABSTRACT

Febrile neutropenia (FN) is a major complication in patients with diffuse large B-Cell lymphoma (DLBCL). Diabetes mellitus (DM) has deleterious effects on the immune system resulting in an increased risk of infections. We evaluated patients with DLBCL who started frontline treatment with R-CHOP, and compared outcomes according to presence of DM comorbidity. Between 2013 and 2018, 218 patients with DLBCL were included. 46 patients (21%) had DM. Rate of admissions for FN was higher for patients with DM (0.7 vs. 0.46 admissions/patient, p = .016), also after age and gender-matched subgroup analysis (p = .004). Improved glycemic control during FN hospitalizations was associated with shorter hospitalizations. Metformin was associated with improved median overall survival in diabetic patients (89 vs. 64 months, p = .018). In conclusion, Patients with DLBCL and DM had higher rates of FN hospitalizations. Improved glycemic control during FN hospitalization was associated with shorter length of stay.

PMID:36067523 | DOI:10.1080/10428194.2022.2118526

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Quantification of Patient-Reported Pain Locations: Development of an Automated Measurement Method

Comput Inform Nurs. 2022 Sep 3. doi: 10.1097/CIN.0000000000000875. Online ahead of print.

ABSTRACT

Patient-reported pain locations are critical for comprehensive pain assessment. Our study aim was to introduce an automated process for measuring the location and distribution of pain collected during a routine outpatient clinic visit. In a cross-sectional study, 116 adults with sickle cell disease-associated pain completed PAINReportItⓇ. This computer-based instrument includes a two-dimensional, digital body outline on which patients mark their pain location. Using the ImageJ software, we calculated the percentage of the body surface area marked as painful and summarized data with descriptive statistics and a pain frequency map. The painful body areas most frequently marked were the left leg-front (73%), right leg-front (72%), upper back (72%), and lower back (70%). The frequency of pain marks in each of the 48 body segments ranged from 3 to 79 (mean, 33.2 ± 21.9). The mean percentage of painful body surface area per segment was 10.8% ± 7.5% (ranging from 1.3% to 33.1%). Patient-reported pain locations can be easily analyzed from digital drawings using an algorithm created via the free ImageJ software. This method may enhance comprehensive pain assessment, facilitating research and personalized care over time for patients with various pain conditions.

PMID:36067491 | DOI:10.1097/CIN.0000000000000875

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Nevin Manimala Statistics

Application of the E-Value to Assess Bias in Observational Research in Plastic Surgery

Plast Reconstr Surg. 2022 Sep 1. doi: 10.1097/PRS.0000000000009624. Online ahead of print.

ABSTRACT

BACKGROUND: The E-value is a statistical measure that is used to quantify the degree of unmeasured confounding that is necessary to undermine the treatment-outcome associations established in observational studies. Despite the substantial amount of observational research that informs evidence-based practice in plastic surgery, sensitivity analyses based on the E-value have not been conducted in the field.

METHODS: We performed a systematic search of the literature to identify meta-analyses of observational studies in plastic surgery. We calculated E-values for various treatment-outcome associations based on the risk, odds, or hazard ratios in each study, to assess unmeasured confounding effects that may influence the validity of the conclusions. We then analyzed the distribution of E-values from pooled versus individual studies.

RESULTS: We identified 45 meta-analyses that met the inclusion criteria, with each containing an average of 3 pooled assessments of observational data. The E-value of the pooled effect estimates ranged from 1.11 to 19.49, with an average value of 3.82. As for the individual effect estimates from each primary study within the meta-analyses, the E-values ranged from 1.00 to 321.50, with an average value of 8.74.

CONCLUSIONS: We determined that E-values vary substantially across the literature and that unmeasured confounding may be present in a substantial number of observational studies. Although extant statistical techniques will continue to be necessary to control for measured confounding, the E-value is a novel concept that can facilitate more robust sensitivity analyses in plastic surgery research.

PMID:36067485 | DOI:10.1097/PRS.0000000000009624

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Risk Factors for Partial Flap Loss in a Free Flap: A 12-Year Retrospective Study of Anterolateral Thigh Free Flap in 303 Lower Extremity Cases

Plast Reconstr Surg. 2022 Sep 1. doi: 10.1097/PRS.0000000000009646. Online ahead of print.

ABSTRACT

BACKGROUND: Despite remarkable improvements in free flap procedures, partial flap losses in perforator flap still occur. This study aimed to analyze partial necrosis cases which underwent reconstruction of the lower extremities using anterolateral thigh (ALT) free flaps and identifies risk factors causing the occurrence of partial necrosis.

METHODS: From January 2005 to February 2017, 303 ALT free flaps were retrospectively analyzed. After collecting patient’s data, receiver operating characteristic (ROC) curve was conducted to find the critical distance between the perforator and the flap margin which distinguishes incidence of partial necrosis. Also, the rate of partial losses was calculated for each section after dividing the distance from the perforator to the flap margin into 1cm sections. Lastly, logistic regression analyses were performed to identify the risk factors.

RESULTS: 43 cases had partial flap losses (14.19%). Flaps with supra-deep fat layer elevation showed the highest rate of partial necrosis (25.53 %) with statistical significance (p = 0.0001). In ROC curve, the cut-off distance was 10.25 cm. In addition, flap tissues 8 cm away from the perforator have a 10.3 % chance of necrosis, whereas those 12 cm away from the perforator have a 22.9 % chance. Lastly, supra-deep fat layer elevation (OR: 3.952) and large flap dimension (OR: 1.041) were risk factors of partial flap necrosis on multivariate analysis.

CONCLUSIONS: The distance from perforator to flap margin, flap elevation layer, and flap dimension affected the occurrence of partial necrosis. Taking these into consideration, ALT free flap of appropriate size and thickness should be harvested.

PMID:36067478 | DOI:10.1097/PRS.0000000000009646

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Surgeon gender-related differences in operative coding in plastic surgery

Plast Reconstr Surg. 2022 Sep 6. doi: 10.1097/PRS.0000000000009609. Online ahead of print.

ABSTRACT

BACKGROUND: Numerous studies in the medical and surgical literature have discussed the income gap between male and female physicians but none have adequately accounted for the disparity.

METHODS: This study was performed to determine whether gender-related billing and coding differences may be related to the income gap. A 10% minimum difference was set a priori as statistically significant. A cohort of 1036 candidates’ nine-month case lists for the American Board of Plastic Surgery (ABPS) over a five year span (2014-2018) was evaluated for relationships between surgeon gender and work RVUs, coding information, major and minor cases performed and work setting. Data was de-identified by the ABPS prior to evaluation. We hypothesized that wRVUS, average codes per case, major cases, and minor cases would be at least 10% higher for male than female physicians.

RESULTS: Significant differences were found between males and females in wRVUs billed, wRVUs billed per case, and the numbers of major cases performed. The average total wRVUs for male surgeons was 19.34% higher than female surgeons (3253.2 [3090.5, 3425.8] versus 2624.1 [2435.2, 2829.6]. Male surgeons performed 14.28% more major cases than females (77.6 [72.7, 82.7] vs 90.5 [86.3, 94.9], p = 0.0002).

CONCLUSIONS: Our findings support the hypothesis that billing and coding practices can, in part, account for income differences between male and female plastic surgeons. Potential explanations include practices focusing on larger and more complex operative cases and differences in coding practices.

PMID:36067475 | DOI:10.1097/PRS.0000000000009609

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“Videofluorographic analysis of swallowing function after total glossolaryngectomy.”

Plast Reconstr Surg. 2022 Sep 1. doi: 10.1097/PRS.0000000000009639. Online ahead of print.

ABSTRACT

Previously, surgeons believed that after total glossolaryngectomy (TGL), swallowing is mainly dependent on gravity. However, swallowing function after TGL varies widely between patients, and a thorough analysis is lacking. We aimed to clarify the post-TGL swallowing function and determine whether it is primarily dependent on gravity. We retrospectively analyzed videofluorographic examinations (VFs) of patients who underwent TGL and free or pedicle flap reconstruction. We enrolled 20 patients (male, n=12; mean age, 61 years; age range, 43 to 89 years). All patients demonstrated constriction of the reconstructed pharynx to some degree, and no patient’s ability to swallow was dependent on gravity alone. VF showed excellent barium clearance in eight patients and poor clearance in 12. All patients with excellent clearance showed strong constriction of the posterior pharyngeal wall, whereas only 8.3% of the patients with poor clearance showed adequate constriction, which was significantly different (p=0.0007). Velopharyngeal closure and lip closure also contributed significantly to excellent clearance (p=0.041). The shape of the reconstructed pharynx (depressed, flat, protuberant) showed no statistically significant association with excellent clearance. Contrary to our previous understanding, the constriction of the remnant posterior pharyngeal wall played an important role in post-TGL swallowing, and gravity played a secondary role. Dynamic posterior pharyngeal wall movement might result from the increased power of the pharyngeal constrictor muscle and compensate for the immobility of the transferred flap. A well-functioning pharyngeal constrictor muscle and complete velopharyngeal and lip closures can contribute to excellent barium clearance in patients after TGL.

PMID:36067466 | DOI:10.1097/PRS.0000000000009639