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Nevin Manimala Statistics

Evaluation of an Initiative to Decrease the Use of Oxygen Supplementation for Category II Fetal Heart Rate Tracings

Obstet Gynecol. 2021 Oct 1;138(4):627-632. doi: 10.1097/AOG.0000000000004544.

ABSTRACT

OBJECTIVE: To examine compliance with a guideline to reduce exposure to supplemental oxygen for category II fetal heart rate (FHR) tracings in normally oxygenated laboring patients.

METHODS: All patients in labor in an urban academic medical center from January 1 to July 31, 2020 were assessed. The preintervention group included those who delivered from January 1 to March 19, 2020. On March 20, 2020, a new guideline took effect that recommended no maternal supplemental oxygen for category II FHR tracings. The postintervention group delivered from March 20 to July 31, 2020. Exclusion criteria were planned cesarean delivery, multiple gestations, delivery at less than 24 weeks of gestation, intrauterine fetal death, and patients who received supplemental oxygen for an oxygen saturation lower than 95%. The primary outcome was the percentage of patients who received oxygen in labor analyzed by control charts and the rules of special cause variation. Chi-squared and t tests were used for secondary outcome assessment. P<.05 was considered significant.

RESULTS: A total of 1,333 patients were included, 474 patients in the preintervention group and 859 in the postintervention group. Oxygen was administered to 22.6% of patients before guideline implementation, compared with 0.6% after the guideline. Special cause variation was detected with an 8-point shift starting the month that the guideline was implemented, indicating statistical significance. There were no differences in any studied secondary maternal or fetal outcomes, although our statistical power to detect differences in infrequent outcomes was limited.

CONCLUSION: This quality-improvement study demonstrated significant adherence to the guideline that supplemental oxygen would no longer be given to patients with category II FHR tracings in the absence of maternal hypoxemia, with no significant change in maternal or perinatal outcomes.

PMID:34623075 | DOI:10.1097/AOG.0000000000004544

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Reduction in Cesarean Delivery Rates Associated With a State Quality Collaborative in Maryland

Obstet Gynecol. 2021 Oct 1;138(4):583-592. doi: 10.1097/AOG.0000000000004540.

ABSTRACT

OBJECTIVE: To assess the extent to which hospitals participating in the MDPQC (Maryland Perinatal-Neonatal Quality Care Collaborative) to reduce primary cesarean deliveries adopted policy and practice changes and the association of this adoption with state-level cesarean delivery rates.

METHODS: This prospective evaluation of the MDPQC includes 31 (97%) of the birthing hospitals in the state, which all voluntarily participated in the 30-month collaborative from June 2016 to December 2018. Hospital teams agreed to implement practices from the “Safe Reduction of Primary Cesarean Births” patient safety bundle, developed by the Council on Patient Safety in Women’s Health Care. Each hospital’s implementation of practices in the bundle was measured through surveys of team leaders at 12 months and 30 months. Half-yearly cesarean delivery rates were calculated from aggregate birth certificate data for each hospital, and differences in rates between the 6 months before the collaborative (baseline) and the 6 months afterward (endline) were tested for statistical significance.

RESULTS: Among the 26 bundle practices that were assessed, participating hospitals reported having a median of seven practices (range 0-23) already in place before the collaborative and implementing a median of four (range 0-17) new practices during the collaborative. Across the collaborative, the cesarean delivery rates decreased from 28.5% to 26.9% (P=.011) for all nulliparous term singleton vertex births and from 36.1% to 31.3% (P<.001) for nulliparous, term, singleton, vertex inductions. Five hospitals had a statistically significant decrease in nulliparous, term, singleton, vertex cesarean delivery rates and four had a significant increase. Nulliparous, term, singleton, vertex cesarean delivery rates were significantly lower across hospitals that implemented more practices in the “Response” domain of the bundle.

CONCLUSION: The MDPQC was associated with a statewide reduction in cesarean delivery rates for nulliparous, term, singleton, vertex births.

PMID:34623072 | DOI:10.1097/AOG.0000000000004540

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Outcomes of the First Pregnancy After Fertility-Sparing Surgery for Early-Stage Cervical Cancer

Obstet Gynecol. 2021 Oct 1;138(4):565-573. doi: 10.1097/AOG.0000000000004532.

ABSTRACT

OBJECTIVE: To evaluate outcomes of the first pregnancy after fertility-sparing surgery in patients with early-stage cervical cancer.

METHODS: We performed a population-based study of women aged 18-45 years with a history of stage I cervical cancer reported to the 2000-2012 California Cancer Registry. Data were linked to the OSHPD (California Office of Statewide Health Planning and Development) birth and discharge data sets. We included patients with cervical cancer who conceived at least 3 months after a fertility-sparing surgery, which included cervical conization or loop electrosurgical excision procedure. Those undergoing trachelectomy were excluded. The primary outcome was preterm birth. Secondary outcomes included growth restriction, neonatal morbidity, stillbirth, cesarean delivery, and severe maternal morbidity. We used propensity scores to match similar women from two groups in a 1:2 ratio of case group participants to control group participants: population individuals without cancer and individuals with cervical cancer (women who delivered before their cervical cancer diagnosis). Wald statistics and logistic regressions were used to evaluate outcomes.

RESULTS: Of 4,087 patients with cervical cancer, 118 (2.9%) conceived after fertility-sparing surgery, and 107 met inclusion criteria and were matched to control group participants. Squamous cell carcinoma was the most common histology (63.2%), followed by adenocarcinoma (30.8%). Patients in the case group had higher odds of preterm birth before 37 weeks of gestation compared with both control groups (21.5% vs 9.3%, odds ratio [OR] 2.7, 95% CI 1.4-5.1; 21.5% vs 12.7%, OR 1.9, 95% CI 1.0-3.6), but not preterm birth before 32 weeks. Neonatal morbidity was more common among the patients in the case group relative to those in the cervical cancer control group (15.9% vs 6.9%, OR 2.5, 95% CI 1.2-5.5). There were no differences in rates of growth restriction, stillbirth, cesarean delivery, and maternal morbidity.

CONCLUSION: In a population-based cohort, patients who conceived after surgery for cervical cancer had higher odds of preterm delivery compared with control groups.

PMID:34623068 | DOI:10.1097/AOG.0000000000004532

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Insight into pediatric-versus adult-onset lichen planus: A retrospective analytical study from Northern India

Indian J Dermatol Venereol Leprol. 2021 Sep 15:1. doi: 10.25259/IJDVL_1_2021. Online ahead of print.

NO ABSTRACT

PMID:34623054 | DOI:10.25259/IJDVL_1_2021

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SGLT2 inhibitors and cardiac remodelling: a systematic review and meta-analysis of randomized cardiac magnetic resonance imaging trials

ESC Heart Fail. 2021 Oct 8. doi: 10.1002/ehf2.13645. Online ahead of print.

ABSTRACT

AIMS: Recent large randomized controlled trials (RCTs) have demonstrated efficacy of sodium-glucose cotransporter-2 inhibitors (SGLT2i) in both preventing and treating heart failure (HF). SGLT2i-induced reversal of left ventricular remodelling has been proposed as a mechanism contributing to this effect.

METHODS AND RESULTS: We performed a systematic review and meta-analysis of RCTs to compare SGLT2i versus placebo (treatment duration >3 months) on cardiac remodelling parameters as measured by cardiac magnetic resonance imaging (cMRI) in patients with HF and/or diabetes. The PubMed and ClinicalTrials.gov databases were searched until 15 June 2021. Our primary outcome was change in absolute left ventricular mass (LVM) from baseline to study endpoint. Secondary outcomes included changes in LVM indexed to body surface area, left ventricular end-systolic volume (LVESV), left ventricular end-diastolic volume (LVEDV), and left ventricular ejection fraction (LVEF) from baseline to study endpoint. The Cochrane Collaboration’s tool was used to assess risk of bias. Five studies representing 408 patients were included. SGLT2i was associated with greater LVM regression compared to placebo (MD, -5.76 g; 95% CI, -10.87 g to -0.64 g, I2 = 73%; overall effect, P < 0.03; four RCTs). Statistical subgroup differences were not observed in our sensitivity analysis focusing on HF with reduced ejection fraction (P = 0.37) and were observed in our sensitivity analysis focusing on diabetes (P < 0.001). SGLT2i was not associated with statistical changes in LV mass indexed to body surface area (I2 = 75%; P = 0.16; five RCTs), LVESV (I2 = 87%; P = 0.07; five RCTs), LVEDV (I2 = 81%; P = 0.20; five RCTs), nor LVEF (I2 = 85%; P = 0.19; five RCTs) versus placebo. Sixty per cent of RCTs had low risk of bias.

CONCLUSIONS: Sodium-glucose cotransporter-2 inhibitors treatment was associated with a reduction in left ventricular mass as assessed by cMRI.

PMID:34623032 | DOI:10.1002/ehf2.13645

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Algorithm for an automatic treatment planning system using a single-arc VMAT for prostate cancer

J Appl Clin Med Phys. 2021 Oct 8. doi: 10.1002/acm2.13442. Online ahead of print.

ABSTRACT

Optimization process in treatment planning for intensity-modulated radiation therapy varies with the treatment planner. Therefore, a large variation in the quality of dose distribution is usually observed. To reduce variation, an automatic optimizing toolkit was developed for the Monaco treatment planning system (Elekta AB, Stockholm, Sweden) for prostate cancer using volumetric-modulated arc therapy (VMAT). This toolkit was able to create plans automatically. However, most plans needed two arcs per treatment to ensure the dose coverage for targets. For prostate cancer, providing a plan with a single arc was advisable in clinical practice because intrafraction motion management must be considered to irradiate accurately. The purpose of this work was to develop an automatic treatment planning system with a single arc per treatment for prostate cancer using VMAT. We designed the new algorithm for the automatic treatment planning system to use one arc per treatment for prostate cancer in Monaco. We constructed the system in two main steps: (1) Determine suitable cost function parameters for each case before optimization, and (2) repeat the calculation and optimization until the conditions for dose indices are fulfilled. To evaluate clinical suitability, the plan quality between manual planning and the automatic planning system was compared. Our system created the plans automatically in all patients within a few iterations. Statistical differences between the plans were not observed for the target and organ at risk. It created the plans with no human input other than the initial template setting and system initiation. This system offers improved efficiency in running the treatment planning system and human resources while ensuring high-quality outputs.

PMID:34623022 | DOI:10.1002/acm2.13442

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Enamel wear against monolithic zirconia restorations: A meta-analysis and systematic review of in vitro studies

J Esthet Restor Dent. 2021 Oct 8. doi: 10.1111/jerd.12823. Online ahead of print.

ABSTRACT

OBJECTIVE: An assessment was performed to identify and evaluate dental enamel wear caused by monolithic zirconia restoration. Literature searches were conducted in PubMed, Science Direct, Cochrane Evidence, and the Cochrane Library up to May 2020.

MATERIAL AND METHODS: Studies were selected for systematic review according to the inclusion (articles conducted on the wear of enamel samples opposing monolithic zirconia) and exclusion (case reports, non-English articles, and monolithic zirconia samples facing other materials rather than human enamel) criteria. Of those, articles on polished and glazed monolithic zirconia subjected to a 50 N vertical load with a range of 240,000-250,000 cycles, equivalent to 1 year of in vivo mastication, were included in the meta-analysis.

RESULTS: In total, 3968 articles were pooled. Twenty-five articles met the inclusion criteria for the systematic review. Three studies were included in the meta-analysis. The results showed that the enamel wear against monolithic zirconia was within the statistically accepted level. Moreover, the polished monolithic zirconia surface caused less enamel wear than the glazed surface.

CONCLUSION: This review indicates that monolithic zirconia restorations cause acceptable antagonist enamel wear. Moreover, the meta-analysis results agreed that the final restoration’s surface texture plays an essential role in the wear process.

CLINICAL SIGNIFICANCE: Monolithic zirconia restorations have been widely used in dental practice because they eliminate the chipping problems resulting from using veneered restorations. With recent technology development, monolithic zirconia has obtained more esthetic features and a more natural look. However, due to the high strength and surface roughness of monolithic zirconia, wear on the antagonist’s teeth was detected. The results showed that this wear amount was statistically acceptable and lower than other ceramics such as feldspathic porcelain and enamel. Furthermore, surface treatment methods must be applied to minimize tooth wear, as polished or glazed surfaces interfere with enamel loss.

PMID:34623015 | DOI:10.1111/jerd.12823

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SWITCHING BETWEEN REFERENCE ADALIMUMAB AND BIOSIMILARS IN CHRONIC IMMUNE-MEDIATED INFLAMMATORY DISEASES: A SYSTEMATIC LITERATURE REVIEW

Br J Clin Pharmacol. 2021 Oct 8. doi: 10.1111/bcp.15101. Online ahead of print.

ABSTRACT

INTRODUCTION: adalimumab is a biological therapy used to treat different chronic inflammatory diseases. At present, there are an increasing number of adalimumab biosimilars. To assume interchangeability between reference adalimumab and biosimilars as acceptable, there should be evidence about efficacy and safety of this switching. Regulation of this practice falls under the authority of individual European Union member states.

OBJECTIVES: to systematically review the evidence on the efficacy, safety, and immunogenicity of switching between reference adalimumab and biosimilars in different chronic immune-mediated inflammatory diseases.

METHODS: the studies presenting data about switching between reference adalimumab and biosimilars were identified by sensitive search strategies in Medline and EMBASE from 1st January 2004 until 30th June 2021.

RESULTS: 471 references were obtained and 21 finally included in the analysis (total number of patients switching: 2802). Eight different adalimumab biosimilars were tested after receiving reference adalimumab. Eight articles included rheumatoid arthritis (RA), 1 miscellaneous rheumatic disease, 6 psoriasis (PSO) and 6 inflammatory bowel disease (IBD) patients. Overall, the efficacy results in the switching groups were comparable to those obtained in the arms of continuous biosimilar and continuous reference adalimumab. There were no significant differences in treatment emergent adverse events, anti-drug or neutralising antibodies among the three groups.

CONCLUSIONS: switching between reference adalimumab and biosimilars has no impact on efficacy, safety and immunogenicity in patients with RA, PSO and IBD. This finding was consistent for the different adalimumab biosimilars analysed. These conclusions could probably be extended to other rheumatic diseases as psoriatic arthritis and ankylosing spondylitis.

PMID:34622969 | DOI:10.1111/bcp.15101

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A comparison of platelet function in cold-stored whole blood and platelet concentrates

Transfusion. 2021 Oct 8. doi: 10.1111/trf.16657. Online ahead of print.

ABSTRACT

BACKGROUND: There is renewed interest in the use of whole blood (WB) for the resuscitation of trauma patients. Platelet function in stored WB compared to platelet concentrates is not well established and was assessed in vitro in this study.

METHODS: Leucocyte-depleted cold-stored WB (CS-WB) was prepared using a Terumo WB-SP Imuflex kit and held at 2-6°C alongside: (A) UK standard pooled platelets stored at 20-24°C (RT-PLTS), (B) pooled platelets stored at 2-6°C (CS-PLTS), and (C) platelet-rich plasma produced using the Terumo kit (CS-PRP), for 21 days. A series of in vitro assays were assessed platelet function.

RESULTS: Platelet count was retained to 57 ± 14% of starting number at day 21 in CS-WB. Over time, CS-WB platelets become more activated, with increased CD62P expression (day 1: 7 ± 3.7% vs. day 21: 59 ± 17.1%) and annexin V binding (day 1: 2 ± 0.2% vs. day 21: 21 ± 15.1%). For comparison, 18.6 ± 6% of platelets in RT-PLTS demonstrated CD62P expression at day 7, whereas annexin V binding in RT-PLTS at day 7 was 2.6 ± 0.5%. Over storage, aggregatory response to agonists decreased in all arms. Functional platelet microparticles increased steadily in CS-WB throughout storage.

CONCLUSION: During storage, platelet count reduced in CS-WB, whereas CD62P expression and annexin V binding increased. This was accompanied by a reduced aggregatory response, although compared to 7-day-old RT-PLTS, CS-WB maintained a maximal response to agonists for longer, suggesting that the shelf life for CS-WB can be considered for up to 21 days.

PMID:34622949 | DOI:10.1111/trf.16657

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Recurrence of postpartum hemorrhage in relatives: A population-based cohort study

Acta Obstet Gynecol Scand. 2021 Oct 8. doi: 10.1111/aogs.14262. Online ahead of print.

ABSTRACT

INTRODUCTION: Studies on the family aggregation of postpartum hemorrhage (PPH) are scarce and with inconsistent results, and to what extent current birthweight influences recurrence between relatives remains to be studied. Further, family aggregation of PPH has been studied from an individual, but not from a public heath perspective. We aimed to investigate family aggregation of PPH in Norway, how birthweight influences these effects, and to estimate the proportion of PPH cases attributable to a family history of PPH and current birthweight.

MATERIAL AND METHODS: Using data from the Medical Birth Registry of Norway, Statistics Norway, and Central Population Registry of Norway we identified individuals as newborns, parents, grandparents, and full and half-siblings, and studied 1 002 687 mother-offspring, 841 164 father-offspring, and 761 011 both-parents-offspring pairs. We used multilevel logistic regression to calculate odds ratios (OR) with 95% CI.

RESULTS: If the birth of the mother but not of the father involved PPH, then the OR of PPH (>500 mL) in the next generation was 1.44 (95% CI 1.39-1.49). If the birth of the father but not of the mother involved PPH, then OR was 1.12 (95% CI 1.08-1.16). These effects were stronger in severe PPH. Recurrence between siblings was highest between full sisters (OR 1.47, 95% CI 1.41-1.52), followed by maternal half-sisters, paternal half-sisters, and partners of full brothers. A family history of PPH or birthweight of 4000 g or more accounted for ≤5% and 15% of the total number of PPH cases, respectively.

CONCLUSIONS: A history of PPH in relatives influenced the recurrence risk of PPH in a dose-response pattern consistent with the anticipated proportion of shared genes. The recurrence was highest through the maternal line.

PMID:34622946 | DOI:10.1111/aogs.14262