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Nevin Manimala Statistics

Late-onset fetal growth restriction management: a national survey

Minerva Obstet Gynecol. 2022 Nov 7. doi: 10.23736/S2724-606X.22.05217-4. Online ahead of print.

ABSTRACT

BACKGROUND: Fetal growth restriction (FGR) is an obstetric condition that increases the risk of adverse neonatal outcomes. FGR antenatal care aims to decrease fetal morbidity and mortality through optimal fetal monitoring. However, no univocal strategies for late-onset FGR outpatient management are available, and this survey investigated gynaecologists’ attitudes concerning outpatient frequency tests.

METHODS: We mailed a survey to 429 Italian gynaecologists. The primary purpose was the ambulatory care of late-onset FGR without doppler alterations evaluation. The queries estimated the self-reported medical practice regarding cardiotocography (CTG) and obstetric ultrasound exams before hospitalization. Statistical analysis was performed with Stata 14.1 (Stata corp., College Station, TX, USA) for symmetrically distributed continuous variables, and the mean differences were analyzed using the t-test. Where appropriate, the proportions between the groups were evaluated using Fisher’s exact or Chi-square test. P values <0.05 were considered statistically significant.

RESULTS: 128 responses (29.8%) from the 429 SCCAL members were available for the survey. 39.9% of respondents had a late FGR standardized protocol. Regarding non-severe FGR with normal fetal doppler, 70.8% suggested a fetal doppler study after one week (92/128), 13.8% (18/128) and 6.9% (9/128) proposed the exam, respectively, two and three times for a week. 0.8% (1/128) of respondents had a daily doppler exam, 7.7% (10/128) did not answer, and 3.1% (4/128) repeated the ultrasound exam to time for a week. The antenatal CTG was offered: 70.8% (92/128) of gynaecologists recommended one weekly CTG, whereas 13.8% (18/128) suggested two. 6.9% (9/128) recommended three weekly tests and 0.8% a daily test. 7.7% (10/128) of gynaecologists did not respond. At least, we investigated the gynaecologist’s recommendations for outpatient EFW evaluation: 59.4% (76/128) repeated EFW after two weeks, 31.3% (40/128) after one week. 3.9% (4/128) and 3.1 (4/128) recommended EFW after three weeks and twice a week.

CONCLUSIONS: Gynaecologists recommend unnecessary cardiotocography and ultrasound Doppler exams for non-severe late-onset FGR with normal doppler. However, additional studies and comprehensive surveys are needed to support a standardized protocol and assess the feto-maternal outcomes impact.

PMID:36345906 | DOI:10.23736/S2724-606X.22.05217-4

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The association between gestational age and maternal adverse outcomes in patients undergoing trial of labor after cesarean

Minerva Obstet Gynecol. 2022 Nov 7. doi: 10.23736/S2724-606X.22.05174-0. Online ahead of print.

ABSTRACT

BACKGROUND: Although successful trial of labor after cesarean (TOLAC) resulting in vaginal birth after cesarean (VBAC) can lead to improved maternal and neonatal outcomes, an unsuccessful TOLAC is associated with increased risk of uterine rupture, higher blood loss, and increased risk of infection. Data remain limited in terms of whether differences in gestational age of patients who attempt TOLAC affect maternal morbidity. Out objective was to examine the association between gestational age and maternal adverse outcomes in women undergoing trial of labor after cesarean.

METHODS: This population-based cross-sectional study used birth data from the U.S. National Vital Statistics from 2014 to 2018. Women with liveborn singleton gestation who underwent TOLAC at 23 – 41 weeks’ gestation were included in the analytic population. The primary outcome was a composite of maternal adverse outcomes: admission to the intensive care unit, blood transfusion, uterine rupture, or unplanned hysterectomy. Secondary outcomes were individual measures within the primary composite outcome. Outcomes were compared between patients who underwent TOLAC at term (37-41 weeks gestational age) and those who underwent TOLAC at preterm (23-36 weeks gestational age). Multivariable analyses adjusted for demographic and obstetric differences between the two groups.

RESULTS: 455,284 patients met inclusion criteria for the study; 39,589 (8.7%) were at a preterm gestational age (GA) and 415,695 (91.3%) were at a term GA. The overall composite maternal adverse outcome was significantly higher for patients undergoing TOLAC at preterm GA (12.0 per 1,000 live births) compared to term GA (8.0 per 1,000 live births; aRR1.42; 95% CI 1.29-1.56). Among individual conditions within the primary composite outcome, preterm gestational age was associated with increased risk of admission to the intensive care unit, blood transfusion, and unplanned hysterectomy.

CONCLUSIONS: In patients who underwent TOLAC, preterm gestational age was associated with increased risk of adverse maternal outcomes.

PMID:36345903 | DOI:10.23736/S2724-606X.22.05174-0

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Pre-donation water and salty snacks to prevent vasovagal reactions among blood donors

Transfusion. 2022 Nov 8. doi: 10.1111/trf.17173. Online ahead of print.

ABSTRACT

BACKGROUND: Minimizing the risk of vasovagal reactions (VVRs) can prevent donor harms and improve donor return. We report the results of a program to reduce VVR rates.

STUDY DESIGN AND METHODS: The program was implemented on June 11, 2017 and consisted in drinking water and eating a salty snack before donating blood, plasma, or platelets. All donations made during the “pre-program period” (October 11, 2015-June 10, 2017) and “post-program period” (June 11, 2017-May 11, 2019) were included. Study outcomes comprised VVRs (any severity) and syncopal VVRs, whether employee- or donor-reported. An interrupted time series (ITS) analysis proxied causality based on the “pre-program trend,” the “immediate trend” (i.e., immediately before versus after the program), and the “post-program trend”. The relative risk (RR) of VVR (along with confidence intervals [CIs]) was reported, overall and stratified by subgroups based on age, sex, donor type (i.e., first-time versus repeat), and donation type (i.e., whole blood versus apheresis).

RESULTS: The monthly VVR rate (any severity) dropped from 4.6% in the pre-program period to 4.3% in the post-program period, and never reached its pre-program level. The ITS analysis revealed a statistically significant and increasing pre-program trend (RR [95% CI] = 1.011 [1.002-1.020]), a statistically significant and decreasing immediate trend (RR [95% CI] = 0.848 [0.743-0.969]), and a non-statistically-significant and stable post-program trend (RR [95% CI] = 0.999 [0.993-1.006]). Similar trends were observed for nearly all high- and low-risk subgroups. No statistically significant trend was observed for syncopal VVRs.

DISCUSSION: These results suggest that the herein-described program durably reduced the incidence of VVRs (any severity) by ~15%.

PMID:36345887 | DOI:10.1111/trf.17173

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Nevin Manimala Statistics

Radar reflector guided axillary surgery in node positive breast cancer patients

Expert Rev Med Devices. 2022 Nov 8:1-5. doi: 10.1080/17434440.2022.2139177. Online ahead of print.

ABSTRACT

INTRODUCTION: In patients with non-palpable breast cancer, the availability of wireless localization techniques facilitates removal of the target lesion. One such technique uses a radar reflector for localization (RRL). This study evaluates the feasibility and effectiveness of RRL to guide excision of axillary lymph nodes in patients with node-positive breast cancer.

METHODS: Our Breast Cancer Database was queried for patients diagnosed with breast cancer, between 5/2017 and 10/2021, who underwent preoperative placement of a radar reflector into a biopsy proven axillary lymph node. Clinicopathologic data were reported using descriptive statistics.

RESULTS: Twenty patients underwent preoperative placement of a radar reflector into the axilla. Intraoperatively, the clip and radar reflector were successfully removed in all patients. Among the 10 patients treated with NAC, 5 patients achieved an axillary pathologic complete response (pCR) and were spared a complete axillary lymph node dissection (cALND). Among the entire cohort, RRL resulted in a 53% reduction in the number of lymph nodes removed.

CONCLUSIONS: Wireless localization of axillary lymph nodes is safe and feasible. The technique ensures excision of biopsy proven positive axillary lymph nodes and enables a targeted approach to assessing the axilla, both in the setting of NAC and upfront surgery.

PMID:36345879 | DOI:10.1080/17434440.2022.2139177

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Evaluation of nasal airway resistance in a cohort of children with primary snoring and maxillary deficiency

Minerva Dent Oral Sci. 2022 Nov 7. doi: 10.23736/S2724-6329.22.04727-1. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of this study is to test whether rapid palatal expansion is effective to improve nasal airway patency in a sample of pediatric patients with primary snoring.

MATERIALS AND METHODS: A group of 21 subjects, 11 girls (52%) and 10 boys (48%), with a mean age of 7.1 years (SD = 1.3; range 4-9 years) were treated with a rapid maxillary expansion (RME) device. Nasal airway resistance was assessed via rhinomanometric exam before (pre) and 6 months after (post) the rapid palatal expansion treatment.

RESULTS: Data analysis showed a statistically significant increase in the mean scores of the results of the rhinomanometric exam between the “pre” and “post” measurements with a significant reduction in total inspiratory and expiratory air resistance values after rapid palatal expansion.

CONCLUSIONS: Our results show that RME treatment is associated with an improvement in nasal airway resistance due to a substantial reduction in nasal resistance associated with the orthopedic action of the orthodontic device.

PMID:36345835 | DOI:10.23736/S2724-6329.22.04727-1

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Nevin Manimala Statistics

Quality of Life Trajectory and Its Mediators in Older Patients With Acute Decompensated Heart Failure Receiving a Multi-Domain Rehabilitation Intervention: Results From the Rehabilitation Therapy in Older Acute Heart Failure Patients Trial

Circ Heart Fail. 2022 Nov 8:e009695. doi: 10.1161/CIRCHEARTFAILURE.122.009695. Online ahead of print.

ABSTRACT

BACKGROUND: As patients with heart failure experience worsening of their condition, including acute decompensated heart failure, quality of life deteriorates. However, the trajectory of quality of life changes and their determinants in the context of the Rehabilitation Therapy in Older Acute Heart Failure Patients trial physical rehabilitation intervention are unknown.

METHODS: Patients ≥60 years old admitted for acute decompensated heart failure (n=349) were randomized to either attention control or intervention. Quality of life outcomes (Kansas City Cardiomyopathy Questionnaire; 12-Item Short-Form Health Survey) were measured at baseline (inpatient), 1 month, and 3 months. Intervention effects were assessed using linear mixed effects regression, including covariates to model the main effects of the intervention and timing of outcome assessments. Mediation analysis determined if changes in Kansas City Cardiomyopathy Questionnaire were due to improvement in physical function (short physical performance battery, 6-minute walk distance).

RESULTS: Baseline Kansas City Cardiomyopathy Questionnaire summary score was similarly poor in the intervention and control arms (40.2±20.6 versus 41.5±20.6). Although the intervention experienced nominally greater Kansas City Cardiomyopathy Questionnaire improvement than control at 1 month (64.7±1.9 versus 61.1±1.9, P=0.13), the difference was not statistically significant until 3 months (67.7±1.9 versus 60.8±1.9, P=0.004). Twelve-Item Short-Form Health Survey Physical and Mental Composite Scores increased in both arms at 1 month and continued improvement only in the intervention. The 3-month improvement in short physical performance battery score explained 64.1% of the improvement in Kansas City Cardiomyopathy Questionnaire (P<0.001).

CONCLUSIONS: In older patients hospitalized for acute decompensated heart failure, quality of life improves in the first month after discharge. The quality of life benefit of a post-discharge physical rehabilitation intervention is detected early with large significant improvements at 3 months achieved primarily through improvement in short physical performance battery.

REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT02196038.

PMID:36345825 | DOI:10.1161/CIRCHEARTFAILURE.122.009695

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Nevin Manimala Statistics

Analysis of incidence data in developmental toxicity studies: Statistical tests to account for litter effects in fetal defect data

Birth Defects Res. 2022 Nov 8. doi: 10.1002/bdr2.2120. Online ahead of print.

ABSTRACT

BACKGROUND: When analyzing fetal defect incidence in laboratory animal studies, correlation in responses within litters (i.e., litter effects) can lead to increased false-positive rates if litter effects are not incorporated into the analysis. Studies of fetal defects require analysis methods that are robust across a broad range of defect types, including those with zero or near-zero incidence rates in control groups.

METHODS: A simulation study compared power and false-positive rates for six approaches across a range of background defect rates and litter size distributions. Statistical methods evaluated included ignoring the litter effect as well as parametric and nonparametric approaches based on litter proportions, generalized linear mixed models (GLMMs), the Rao-Scott Cochran-Armitage (RSCA) trend test, and a modification to the RSCA (mRSCA) introduced here to improve estimation at low background rates. These methods were also applied to a common and a rare defect from two prenatal developmental toxicology studies conducted by the National Toxicology Program (NTP).

RESULTS: At background defect rates of 1%, the mRSCA and parametric litter proportion methods provided gains in power over the nonparametric litter proportion method, the GLMM method, and the RSCA method. Simulations involving litter loss in high-dose groups showed loss of power for both litter proportion methods.

CONCLUSIONS: The mRSCA test developed here compares favorably with other litter-based approaches and is robust across a range of background defect rates and litter size distributions, making it a practical choice for prenatal developmental toxicology studies involving both common and rare fetal defects.

PMID:36345811 | DOI:10.1002/bdr2.2120

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Cerebrospinal Fluid Otorrhea After a Routine Tympanostomy Tube Placement: A Review of the Literature on Hyrtl Fissure

Ear Nose Throat J. 2022 Nov 8:1455613211039045. doi: 10.1177/01455613211039045. Online ahead of print.

ABSTRACT

OBJECTIVE: To review the literature on Hyrtl fissure (HF) and contribute our experience with a 2-year old who developed cerebrospinal fluid (CSF) otorrhea during routine tympanostomy tube placement.

METHODS: Data Sources: Pubmed and Google Scholar searches were conducted of articles in the English language literature from all time periods using the words Hyrtl, Hyrtl’s fissure, HF, and tympanomeningeal fissure. Study Selection: All relevant articles were reviewed to identify cases of HF.

RESULTS: Data Extraction: Nineteen cases, including ours, are described. Patient characteristics, method(s) of diagnosis and repair, and outcomes are reported. Computed tomography and intraoperative endoscopic images from our case are included. Presentation is more common in children (66.7% of cases where age was stated, n = 10) than in adults (33.3%, n = 5), and is most commonly unilateral (89.5%, n = 17). Cerebrospinal fluid otorrhea was the most common presentation. Six were discovered after tympanostomy tube placements while 3 were identified during cochlear implant work-up or after device failure. Surgical approaches described include endaural, transcanal, retrosigmoid, postauricular, and posterior fossa endoscopic. Multiple materials including bone wax, bone pate, fascia, muscle, and tissue sealant have been used. Our case describes an endoscopic repair in a child, which was successful at a 2-year follow-up. Data Synthesis: The small number of cases limits the utility of statistical analysis (n = 19).

CONCLUSIONS: Hyrtl fissure is a rare but important entity that may be discovered when routine procedures have unexpected results. Hyrtl fissure should be included in the differential diagnosis when there is persistent clear otorrhea after a tympanostomy tube, cochlear implant misinsertion, meningitis, or unexplained middle ear effusion in an adult.

PMID:36345799 | DOI:10.1177/01455613211039045

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Uncollimated gamma camera measurements at two metres to the patient provide a practical and statistically robust method for SeHCAT retention calculation

Nucl Med Commun. 2022 Dec 1;43(12):1247-1253. doi: 10.1097/MNM.0000000000001626. Epub 2022 Oct 17.

ABSTRACT

[75Se]tauroselcholic acid (SeHCAT) retention studies may be performed using a collimated or uncollimated (intrinsic) gamma camera, with trade-offs between counting sensitivity, collision risk, and stray source influence. In this work, we evaluate the uncertainty in SeHCAT studies performed in ‘outer room’ mode, where the patient sits or stands two metres away from the uncollimated camera face. 768 SeHCAT studies performed at the Royal Free Hospital were analysed retrospectively, and in all cases, the absolute uncertainty was found to be well within the clinically acceptable limit of ±1 percentage point at 15% retention. The mean counting sensitivity was found to be 1.64 cps/kBq, which is higher than collimated counting but lower than uncollimated counting with the patient on the couch. Seeing as the outer room method does not require patients to transfer onto the couch it may provide savings in setup time which may offset the necessarily longer acquisition time. Because the patient does not come into close proximity to the unprotected camera face the risk of collision is also reduced. Spectra from a SeHCAT capsule in a water-filled torso phantom were used to examine the potential impact of modifying the energy windows. We recommend adopting a wide central photopeak and downscatter window (160-296 keV) plus a lower photopeak window (111-159 keV), which may provide significant improvements in sensitivity. This improved sensitivity could be used to reduce the acquisition time, which is of particular interest in the context of increasing numbers of referrals for SeHCAT retention tests.

PMID:36345770 | DOI:10.1097/MNM.0000000000001626

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Bone metastases in prostate cancer – Gallium-68-labeled prostate-specific membrane antigen or Fluorine 18 sodium fluoride PET/computed tomography – the better tracer?

Nucl Med Commun. 2022 Dec 1;43(12):1225-1232. doi: 10.1097/MNM.0000000000001621. Epub 2022 Oct 19.

ABSTRACT

OBJECTIVE: The objective was to assess the roles of 68Ga-PSMA PET/CT and 18F-NaF PET/CT in evaluation of skeletal metastatic lesions in prostate cancer.

METHODS: Two hundred consecutive prostate cancer patients who had undergone 68Ga-PSMA PET/CT and 18F-NaF PET/CT at baseline evaluation (n = 80) and following suspected recurrence or disease progression (restaging) (n = 120) were analyzed retrospectively.

RESULTS: PSMA and NAF scans were positive for skeletal metastatic lesions in 67% (134 patients) and negative in 33% (66 patients). The scans were concordant in 80% (160 patients: 66 negative and 94 positive) and discordant in 20% (40 patients). Among 40 discordant results, 14 were baseline and 26 were restaging studies. PSMA detected more number of lesions in 11 (nine baseline and two restaging). These were true positive marrow or lytic metastatic lesions. NaF revealed more number of lesions in 29 (5 initial and 24 restaging). These were false positive on follow-up imaging. No statistical difference (P value = 0.7 by McNemar test) between the two scans for identifying absence or presence of at least one skeletal lesion was noted at baseline staging.

CONCLUSION: Though, both 18F-NaF and 68Ga-PSMA are excellent tracers for evaluation of skeletal metastases in prostate cancer, there is a distinct advantage of 68Ga-PSMA PET/CT due to detection of additional skeletal lesions and absence of false positive lesions. In addition, absence of PSMA avidity in healed metastases in the restaging setting opens up new avenue for assessment of response of skeletal metastases.

PMID:36345767 | DOI:10.1097/MNM.0000000000001621