Category: Statistics

J Gynecol Obstet Hum Reprod. 2021 Nov 13:102271. doi: 10.1016/j.jogoh.2021.102271. Online ahead of print.

ABSTRACT

INTRODUCTION: Up to 30% of couples may face secondary infertility. The impact of ectopic pregnancy, spontaneous abortion, pregnancy termination or live birth with caesarean section may impair further fertility in different ways. However, secondary infertility after physiological vaginal life childbirth has been little studied. The aim of this study was to describe the population and the fertility issues and analyze the predictive factors of success in in vitro fertilization in women presenting secondary infertility after a physiological vaginal childbirth.

MATERIAL AND METHODS: This single-centre retrospective study included women aged 18-43 years consulting between 2013 and 2020 for secondary infertility in a couple having already had previous vaginal life childbirth. Couples’ characteristics, management decision after the first consultation and IVF outcomes were analyzed.

RESULTS: Secondary infertility was found in 286 couples, out of whom 138 had a history of vaginal life childbirth. Population was characterized by an advanced female age and overweight. After the first consultation, IVF was performed in only 40% of couples. No predictive factor of live birth was found.

CONCLUSION: Our study shows that in couples with secondary infertility after prior physiological delivery cigarette smoking is frequent in male partners, and ovarian reserve markers are altered. However, no statistically significant predictive factor of live birth after IVF treatment has been identified. Further large prospective studies are necessary.

PMID:34785399 | DOI:10.1016/j.jogoh.2021.102271

Ann Vasc Surg. 2021 Nov 13:S0890-5096(21)00883-9. doi: 10.1016/j.avsg.2021.10.047. Online ahead of print.

ABSTRACT

OBJECTIVE: to identify predictors of long-term aortic diameter change and disease progression in a population cohort of patients with newly diagnosed aortic dissection (AD), intramural hematoma (IMH), or penetrating aortic ulcer (PAU).

METHODS: We used the Rochester Epidemiology Project record linkage system to identify all Olmsted County, MN-USA, residents diagnosed with AD, IMH, and PAU (1995-2015). The endpoints were aortic diameter change, freedom from clinical disease progression (any related intervention, aortic aneurysm, new aortic syndrome, rupture or death) and disease resolution (complete spontaneous radiological disappear). Linear regression was used to assess aortic growth rate; predictors of disease progression were identified with Cox proportional hazards.

RESULTS: Of 133 incident cases, 46 ADs, 12 IMHs, and 28 PAUs with sufficient imaging data were included. Overall median follow-up was 8.1 years. Aortic diameter increase occurred in 40 ADs (87%, median 1.0 mm/year), 5 IMHs (42%, median 0.2 mm/year) and 14 PAUs (50%, median 0.4 mm/year). Symptomatic presentation (P=.045), connective tissue disorders (P=.005), and initial aortic diameter >42 mm (P=.013) were associated with AD growth rate. PAU depth >9 mm (P=.047) and female sex (P=.013) were associated with aortic growth rate in PAUs and IMHs. At 10 years, freedom from disease progression was 22% (95%CI 12-41) for ADs, 44% (95%CI 22-92) for IMHs, and 46% (95%CI 27-78) for PAUs. DeBakey I/IIIB AD (HR 3.09; P=.038), initial IMH aortic diameter (HR 1.4; P=.037) and PAU depth >10 mm (HR 3.92; P=.018) were associated with disease progression. No AD spontaneously resolved; resolution rate at 10 years was 22% (95%CI 0-45) for IMHs and 11% (95%CI 0-23) for PAUs.

CONCLUSIONS: Aortic growth and clinical disease progression are observed in most patients with aortic syndromes, while spontaneous resolution is uncommon. Predictors of aortic growth and disease progression may be used to tailor appropriate follow-up and eventual early intervention.

PMID:34785342 | DOI:10.1016/j.avsg.2021.10.047

J Allergy Clin Immunol Pract. 2021 Nov 13:S2213-2198(21)01259-9. doi: 10.1016/j.jaip.2021.10.068. Online ahead of print.

ABSTRACT

BACKGROUND: Autonomy is the ability of patients to make informed medical decisions. Autonomy is rooted in disease state understanding. Medical ethics, especially the principle of autonomy, plays an important role in healthcare delivery when caring for diverse populations.

OBJECTIVE: We sought to identify patient characteristics that influence autonomy.

METHODS: 295 adults with moderate to severe asthma completed two surveys at the beginning of a one year randomized clinical trial. The Navigating Ability and Inhaled Corticosteroids Knowledge questionnaires were combined to create a 21-question assessment of autonomy with possible scores ranging from 10-105. Linear regression was performed on the derived autonomy score predicted by patient baseline characteristics.

RESULTS: Comparison revealed statistically significant differences in baseline autonomy scores in patients who reported Spanish as their primary language (p=0.01), patients with diabetes (p=0.01), and those with depressive symptoms (p=0.03) at -11.4 (95% CI, -20.5, -2.3), -4.8 (95% CI, -8.3, -1.3), and -3.1 (95% CI, -5.9, -0.3) points respectively. Non-Hispanic White participants on average were found to have 8.2 (95% CI, 4.5, 12.0) points higher autonomy scores compared to non-Hispanic Black participants (Bonferroni adjusted p<0.01). Patients with higher functional health literacy had higher autonomy scores (coefficient=0.24, 95% CI, 0.1, 0.4, p<0.01) CONCLUSIONS: Autonomy is associated with comorbidities, demographics, and literacy. These results may reflect differences in social, educational, and economic opportunities encountered by patients. Further investigation is needed to assess and understand how socioeconomic and educational factors influence autonomy. By identifying differences in autonomy based on baseline patient characteristics, this project serves as an initial step in adjusting current and developing new treatment guidelines and interventions to improve patient autonomy.

PMID:34785390 | DOI:10.1016/j.jaip.2021.10.068

Ann Anat. 2021 Nov 13:151855. doi: 10.1016/j.aanat.2021.151855. Online ahead of print.

ABSTRACT

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is the gold standard method for bariatric surgery and leads to substantial improvements in Type 2 Diabetes mellitus. However, many patients experience relapses in diabetes five years after undergoing this aggressive surgical procedure. We focus on beta-cell population changes and absorptive intestinal consequences after RYGB in a healthy nonobese animal model after a long survival period.

METHODS: For our purpose, we use three groups of Wistar rats: RYGB-operated, surgical control (Sham) and fasting control. We measure alpha-, beta-cell mass; transcription (Arx, and Pdx-1) and proliferation (Ki67) factors; glucose tolerance and insulin release after oral glucose tests; histological adaptive changes in the jejunum; and intestinal glucose transporters.

RESULTS: Our results showed an early increase in insulin secretion after surgery, that decrease at the end of the study. The beta-cell mass reduces twenty-four weeks after RYGB, which coincides with decrease of Pdx-1 transcription promoter factor. These was coincident with an increase in alpha-mass and a high expression of Arx in RYGB group.

CONCLUSIONS: The analysis of all data showed beta-cell mass transdifferentiation into alpha-cell mass in RYGB rats. Due to long-term exhaustion of the beta-cell population by hyperinsulinism derived from digestive tract adaptation to surgery.

PMID:34785322 | DOI:10.1016/j.aanat.2021.151855

Ann Vasc Surg. 2021 Nov 13:S0890-5096(21)00873-6. doi: 10.1016/j.avsg.2021.10.039. Online ahead of print.

ABSTRACT

OBJECTIVES: Contrast induced nephropathy occurs in up to 7.5% of cases in endovascular aortic repair (EVAR). Carbon Dioxide (CO₂) has been proposed as an alternative agent to iodinated contrast medium (ICM); however, specific protocols are not universally adopted, and the visualization of the renal arteries may be suboptimal in some cases. The aim of this study was to analyze our CO₂-EVAR experience with automatic injections, in order to identify the anatomical characteristics associated with the best visualization of all the aortic vessels, with particular attention to the lowest renal artery (LoRA).

METHODS: From 2016 to 2019, all EVAR performed with either CO₂ or ICM were analyzed and compared. CO₂-EVAR was performed using an automated injector (600 mmHg pressure; 100 cc volume); a small amount of ICM was injected in case of difficulty in LoRA visualization or doubts at the completion angiogram. Clinical and CT-Scan preoperative characteristics were considered. The study endpoints were technical success, amount of ICM and radiation dose, postoperative renal function and possible CO₂-related adverse events. Statistical analysis was by Fisher’s exact, t-Student, Mann-Whitney tests and ROC curve.

RESULTS: In the considered period, 321 EVAR procedures, 72 (22.4%) with CO₂ and 249 (77.6%) with ICM, were performed. The two groups were similar for clinical characteristics and preoperative renal function. ICM was injected in a significantly lower amount in the CO₂-EVAR group (52.8 ± 6.1 vs. 88.1 ±9.2 cc, p<0.001), which received a significantly higher mean radiation dose (Total DAP: 500550.8 ± 377394.6 mGy/cm² CO₂-EVAR vs. 332301.8 ±230139.3 mGy/cm² ICM-EVAR, p=0.001). Postoperative eGFR decreased significantly less in the CO₂-EVAR (2.3 ± 1.1 ml/min) compared with the ICM-EVAR group (10.6 ±5.3 ml/min), p<0.001. LoRA was correctly visualized in 50/72 (69.4%) cases of CO₂-EVAR, which had a significantly longer proximal neck [Median (IQR): 30 (14) vs. 18 (15) mm, p=0.001]. At ROC curve, a proximal neck length >24.5 mm was predictive of LoRA visualization (72.1% sensitivity, 73.8% specificity). Three CO₂-EVAR cases had intraoperative transient hypotension with no consequences. Sixteen/72 (22.2%) CO₂-EVAR procedures were performed using 0 cc of ICM.

CONCLUSIONS: CO₂-EVAR by automated injections is safe and requires a lower amount of ICM if compared with ICM-EVAR, with a consequent significant benefit on postoperative renal function. If specific anatomical situations are present, ICM may be completely unnecessary. The radiation dose is however significantly higher, therefore procedural protocols need further refinements.

PMID:34785338 | DOI:10.1016/j.avsg.2021.10.039

Contemp Clin Trials. 2021 Nov 13:106620. doi: 10.1016/j.cct.2021.106620. Online ahead of print.

ABSTRACT

In the U.S., older adults hospitalized with acute episodes of chronic conditions often are rehospitalized within 30 days of discharge. Numerous studies reveal that poor management of the complex needs of this population remains the norm. METHODS: This prospective, intent-to-treat, randomized controlled trial (RCT) will assess the effects of replicating the rigorously studied Transitional Care Model (TCM) in four U.S. healthcare systems. The TCM is an advanced practice registered nurse led, team-based, care management intervention that supports older adults throughout vulnerable care episodes that span hospital to home. This RCT will compare health and economic outcomes demonstrated by at-risk older adults hospitalized with heart failure, chronic obstructive pulmonary disease or pneumonia randomized to receive usual discharge planning (control group, N = 800) to those observed by a similar group of older adults randomized to receive the TCM protocol (N = 800). The primary outcome is number of rehospitalizations at 12 months post-discharge, with secondary resource use outcomes measured at multiple intervals. Patient experience with care, health and quality of life outcomes will be assessed at 90 days post-discharge. DISCUSSION: Based on health and economic benefits demonstrated in multiple NIH funded RCTs, the study team hypothesizes that the intervention group, both within and across participating health systems, will have decreased acute care resource use and costs at 12 months and better ratings of the care experience and health and quality of life through 90 days post-discharge compared to the control group. The impact of COVID-19 on implementation of this study also is discussed.

PMID:34785306 | DOI:10.1016/j.cct.2021.106620

Curr Probl Cardiol. 2021 Nov 13:101047. doi: 10.1016/j.cpcardiol.2021.101047. Online ahead of print.

ABSTRACT

INTRODUCTION: Patients with advanced chronic kidney disease (CKD) have largely been excluded from randomized control trials (RCTs) in heart failure (HF). This creates a paucity of high quality evidence for guideline directed medical therapy (GDMT), particularly in patients with heart failure with reduced ejection fraction (HFrEF) and CKD.

METHODS: This is a systematic review looking at the patterns and rates of inclusion of CKD in RCTs among patients with HFrEF. The search included RCTs from January 2010 to December 2020. A heat map was constructed to reflect the stages of CKD stages. The percentage of studies that included advanced CKD (stages 4 to 5) was recorded and log transformed, and then fitted into a time regression model. A p value of <0.05 was considered statistically significant.

RESULTS: Out of the 3052 screened, 706 studies were included in the analysis. Only 61% of the RCTs reported at least some information on kidney function. There was a trend of increase in percentage of studies that included CKD stages 4 to 5 from years 2010 to 2020. This was confirmed with a statistically significant linear trend p=0.02 while the percentage of studies that included dialysis and kidney transplant recipients remained consistently low.

CONCLUSION: There is a paucity of high-quality evidence for GDMT in the HFrEF population with CKD, particularly in those with advanced non-dialytic CKD, those on maintenance dialysis and kidney transplant recipients. There is a pressing need for wider inclusion of patients with advanced CKD in RCTs of GDMT in HFrEF.

PMID:34785259 | DOI:10.1016/j.cpcardiol.2021.101047

Arthroscopy. 2021 Nov 13:S0749-8063(21)00982-8. doi: 10.1016/j.arthro.2021.11.007. Online ahead of print.

ABSTRACT

PURPOSE: To compare the biomechanical effects of superior capsule reconstruction graft fixation length determined at 20° and 40° glenohumeral (GH) abduction. .

METHODS: Humeral translation, rotational range of motion (ROM) and subacromial contact pressure were quantified at 0°, 30°, and 60° of GH abduction in the scapular plane in 6 cadaveric shoulders for: intact; massive rotator cuff tear; SCR with a dermal allograft fixed at 20° GH abduction (SCR 20); and SCR fixed at 40° GH abduction (SCR 40). Statistical analysis was conducted using repeated measures ANOVA and paired t-test (P < 0.05).

RESULTS: Massive cuff tear significantly increased total ROM compared to intact at 0° and 60° abduction. SCR 20 or SCR 40 did not affect ROM. Compared to intact, the massive cuff tear significantly increased superior translation an average of 4.6 ± 0.5 mm at 9/12 positions (P ≤ 0.002). Both SCR 20 and SCR 40 reduced superior translation compared to massive cuff tear (P < 0.05); however, SCR 40 significantly decreased superior translation compared to SCR 20 at 0° abduction (P ≤ 0.046). Peak subacromial pressure for massive cuff tear increased an average of 486.8 ± 233.9 kPa relative to intact at 5/12 positions (P ≤ 0.037).; SCR 20 reduced peak subacromial pressure at 2/12 positions (P ≤ 0.012) while SCR 40 achieved this at 6/12 (P ≤ 0.024).

CONCLUSION: SCR with dermal allograft fixed at 20° or 40° of GH abduction decreases GH translation and subacromial pressure without decreasing range of motion.

PMID:34785299 | DOI:10.1016/j.arthro.2021.11.007

Sci Total Environ. 2021 Nov 13:151496. doi: 10.1016/j.scitotenv.2021.151496. Online ahead of print.

ABSTRACT

Biodiversity measures deliver valuable ecological information by reflecting a range of ecosystem processes. However, the accuracy of environmental assessment based on species patterns may often be affected by insufficient survey details. The comprehensive evaluation of plant taxa richness in rivers requires an extensive sampling effort. The use of Hill numbers and Chao estimators improves species diversity assessment based on a feasible number of samples. The aim of this work was to identify macrophyte groups, associated with various species traits, which are rich in species, as well as those whose detection is particularly difficult as it requires an exceptional sampling effort (sources of dark diversity). Analyses were performed with the use of Hill numbers and Chao estimators. It was shown that the field identification of all estimated macrophytes is particularly difficult for low trophy indicators and generally submerged plants, as well as for small-leaved species. A field survey encompassing the full (expected) macrophyte diversity encountered within a river is easiest to perform in the case of free-floating plants and large-leaved macrophytes, as well as for species with high trophic tolerance. The study proved that ecological assessment of rivers based on a small number of sampling units may lead to incorrect diversity estimates. Conversely, the estimation of diversity patterns at the level of the Shannon and Simpson indices does not require extensive sampling, and the extrapolation approach is not needed. The effectiveness of diversity assessment in fluvial ecosystems can be increased by extrapolation of gray diversity which can be considered in planning of monitoring programs. Moreover even estimated dark diversity bight be already efficient to identify ecological pattern and when comparing biodiversity across regions and ecosystems.

PMID:34785227 | DOI:10.1016/j.scitotenv.2021.151496

Chest. 2021 Nov 13:S0012-3692(21)04288-4. doi: 10.1016/j.chest.2021.11.005. Online ahead of print.

ABSTRACT

BACKGROUND: Definitions for central lung cancer have been ambiguous in guidelines, causing difficulty in selecting candidates for invasive mediastinal staging among patients with radiologically node-negative, early-stage lung cancer.

RESEARCH QUESTION: What is the optimal definition for central lung cancer, which is robust to inter-reader and institutional variation, to select candidates for invasive mediastinal staging among those with clinical T1N0M0 lung cancer?

STUDY DESIGN AND METHODS: Two retrospective cohorts were evaluated for the associations of central lung cancer according to 13 definitions based on chest CT with occult nodal metastasis. Univariable and multivariable ordinal logistic regression analyses were performed with the pathological N category as an ordinal outcome. Robust definitions, which retained statistical significance across multi-reader, dual-institutional datasets, were identified. For these definitions, binary diagnostic performance and inter-reader agreement were investigated.

RESULTS: In the two cohorts, 807 patients (median age, 63 years; interquartile range, 56-71 years; 410 women; 33 pN1, 48 pN2, and 1 pN3) and 510 patients (median age, 65 years; interquartile range, 58-71 years; 267 women; 33 pN1, 20 pN2, and no pN3) were included, respectively. Three definitions robust to inter-reader variation and dataset heterogeneity were identified: definition 7 (concentric lines arising from the midline, inner one-third, medial margin; adjusted odds ratio [OR], 2.01; 95% confidence interval [CI], 1.13-3.51; P=0.02), definition 10 (location index-based inner one-third, center; adjusted OR, 3.60; 95% CI, 1.49-8.25; P=0.003), and definition 12 (location index-based inner one-third, medial margin; adjusted OR, 3.57; 95% CI, 1.91-6.52; P<0.001). Definition 12 showed higher inter-reader agreement than definition 7 (Cohen κ, 0.80 vs. 0.66; P=0.005). Nevertheless, the sensitivity and positive predictive value of the three definitions were below 50%.

INTERPRETATION: Three definitions exhibited robust associations with occult nodal metastasis. However, selecting candidates for invasive mediastinal staging solely based on a central tumor location would be suboptimal.

PMID:34785237 | DOI:10.1016/j.chest.2021.11.005