Category: Statistics

Braz J Phys Ther. 2021 Aug 30:S1413-3555(21)00084-8. doi: 10.1016/j.bjpt.2021.07.006. Online ahead of print.

ABSTRACT

BACKGROUND: Quarantine periods change routines and behaviors with potential impact on different health outcomes.

OBJECTIVE: To determine the association between changes in physical activity and sedentary behaviors with changes in back pain during the COVID-19 pandemic quarantine among Brazilian adults.

METHODS: This was a nationwide survey through online questionnaires using data from 43,062 adults (≥ 18 years of age). Information on back pain was assessed using questions about episodes of back pain and worsening symptoms during the quarantine. The pattern of movement behaviors adopted before and during the pandemic were considered for physical inactivity (< 150 min/week of activity), high TV-viewing (≥ 4 h/d), and high computer/tablet use (≥ 4 h/d). Covariates included sex, age group, academic achievement, skin color, working status during the quarantine, and adherence to the quarantine. Logistic regression models were used for statistical analyses (weighted for national representativity).

RESULTS: Becoming inactive (OR=1.76, 95% CI: 1.32, 2.37), with high TV-viewing (OR=1.35, 95% CI: 1.14, 1.61) and high computer/tablet use (OR=1.39, 95% CI: 1.11, 1.73) during the pandemic were associated with a higher incidence of back pain. The incidence of physical inactivity was also associated with increased back pain (OR=2.71, 95%CI: 1.64, 4.48).

CONCLUSIONS: We conclude that increased physical inactivity and sedentary behaviors due to the COVID-19 pandemic quarantine are associated with the incidence and worsening symptoms of back pain among Brazilian adults.

PMID:34548211 | DOI:10.1016/j.bjpt.2021.07.006

Fertil Steril. 2021 Sep 18:S0015-0282(21)01986-5. doi: 10.1016/j.fertnstert.2021.08.040. Online ahead of print.

ABSTRACT

OBJECTIVE: To analyze the impact on live birth rates (LBRs) of the individualized luteal phase support (termed iLPS) in patients with low serum progesterone (P) levels compared with patients without iLPS.

DESIGN: Retrospective cohort study, December 1, 2018, to May 30, 2019.

SETTING: Private medical center.

PATIENT(S): A total of 2,275 patients checked for serum P on the day of blastocyst transfer were analyzed. During the study period, 1,299 patients showed serum P levels of ≥9.2 ng/mL, whereas 550 showed serum P levels of <9.2 ng/mL and received iLPS. Additionally, a historical group of 426 patients with serum P levels of <9.2 ng/mL but no iLPS were used for comparison. Eligible patients were aged ≤50 years with adequate endometrium morphology after receiving estrogens. Luteal phase support was provided with micronized vaginal P (MVP) to all women. Patients with personalized initiation of exogenous P according to the endometrial receptivity assay test, polyps, fibroids distorting the cavity, or hydrosalpinx were not included in the analysis.

INTERVENTION(S): As routine practice since December 2018, patients with low serum P levels received an iLPS with a daily injection of 25 mg of subcutaneous P from the day of embryo transfer (ET) in addition to standard LPS (400 mg of MVP twice a day).

MAIN OUTCOME MEASURE(S): Live birth rate.

RESULT(S): The LBR was 44.9% in the iLPS cases vs. 45.0% in patients with normal serum P levels (crude odds ratio [OR], 1.0; 95% confidence interval [CI], 0.82-1.22). By regression analysis, low serum P levels did not affect the LBR after adjusting for possible confounders (age, oocyte origin, fresh vs. frozen, day of ET, embryo quality, number of embryos transferred) (adjusted OR, 0.99; 95% CI, 0.79-1.25). Similarly, no differences were observed in other pregnancy outcomes between groups. The LBR was significantly higher in the group of patients who received additional subcutaneous P (iLPS) compared with the historical group with low serum P levels and no iLPS (44.9% vs. 37.3%; OR, 1.37; 95% CI, 1.06-1.78). In the overall population, patients showing P levels of <9.2 ng/mL on the day of ET were slightly younger and had higher body mass index and lower estradiol and P levels during the proliferative phase compared with patients with P levels of ≥9.2 ng/mL. No differences were observed with regard to the time in between the last dose of MVP and the serum P determination. After a multivariable logistic regression analysis, only body mass index and estradiol levels in the proliferative phase reminded statistically significant. Significant differences in the LBR were observed between patients with serum P levels of <9.2 ng/mL without iLPS and patients with serum P levels of ≥9.2 ng/mL when using either own or donated oocytes.

CONCLUSION(S): Individualized LPS for patients with low serum P levels produces LBRs similar to those of patients with adequate serum P levels.

PMID:34548167 | DOI:10.1016/j.fertnstert.2021.08.040

Fertil Steril. 2021 Sep 18:S0015-0282(21)01991-9. doi: 10.1016/j.fertnstert.2021.08.045. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the intraindividual agreement of the sperm chromatin dispersion (SCD) assay results to assess sperm DNA fragmentation (SDF) in men with infertility.

DESIGN: Diagnostic test reliability study.

SETTING: Andrology laboratories.

PATIENT(S): A total of 219 men with infertility.

INTERVENTION(S): Sperm DNA fragmentation assessment in two ejaculates of the same subjects within a 3-month interval, using the SCD assay performed and analyzed by the same observers under similar testing conditions.

MAIN OUTCOME MEASURE(S): Cohen’s κ statistics to assess the degree of agreement between the pairs of results after converting the nominal SCD values into categorical data, that is, normal (<20%), intermediate (21%-29%), and high (≥30%) SDF rates. We also assessed the pairs of results using reliability measures for numerical variables (intraclass correlation coefficient for consistency using the two-way mixed-effects model and Bland-Altman plots).

RESULT(S): The degree of agreement in classifying patients according to normal and pathological SDF classes was overall substantial (κ = 0.632; 95% confidence interval [CI], 0.546-0.718). A total of 76.7% of individuals were classified under the same class using paired ejaculates. The agreement rate was highest (approximately 80%) in ejaculates initially classified as either normal or high and lowest (approximately 60%) among those with intermediate SDF levels. The frequency of intermediate SDF ejaculates downgraded to normal or upgrade to high SDF classes in the second test was similar (approximately 20%). The intraclass correlation coefficient was 0.856 (95% CI, 0.812-0.887), and the mean difference between the pairs of observations was 0.80% (95% CI, -0.72 to 2.23), indicating no systematic difference between paired observations.

CONCLUSION(S): Our study indicates a substantial intraindividual agreement of paired SCD assay results to classify men with infertility into three SDF categories: normal, intermediate, and high. The reliability of the SCD assay was adequate and exceeded 0.80 using two ejaculates analyzed within a 3-month interval under similar conditions. Although this evidence overall supports a single SCD test for patient classification using predefined SDF thresholds, particularly when the first test shows normal or high SDF levels, one in four men will have discordant values in paired ejaculates. Clinicians should be judicious when using SDF test results in decision-making.

PMID:34548170 | DOI:10.1016/j.fertnstert.2021.08.045

Gynecol Oncol. 2021 Sep 18:S0090-8258(21)01326-3. doi: 10.1016/j.ygyno.2021.08.028. Online ahead of print.

ABSTRACT

OBJECTIVES: In a prospective study of platinum-resistant ovarian cancer patients, we examined whether the Disease-related Symptoms-Physical (DRS–P) scale of the NCCN/FACT-Ovarian Cancer Symptom Index-18 (NFOSI-18) is responsive to clinical change in patients estimated by their provider to survive at least six months.

METHODS: The NFOSI-18, and other FACT measures, was collected at study entry and 3 and 6 months post-enrollment. Measures were compared for those who died or dropped off study prior to 3 months or prior to 6 months (assumed as health deterioration over time), or those who stayed on study through 6 months (presumed as stable disease over time). Statistical analyses included a fitted linear mixed model for estimating the group differences over time, Cox regression to assess the probability of survival with patient-reported outcomes, and effect size.

RESULTS: DRS-P scores of patients who completed only one assessment were significantly lower compared to patients who were able to complete two assessments [5.9 points lower (2.0-9.8); p < 0.01], or three assessments [8.1 points lower (4.8-11.5); p < 0.01]. Measures of abdominal discomfort, functional well-being, emotional well-being, and quality of life were also significant, but treatment side effects were not. Further, in every scale except for neurotoxicity, higher (better) baseline scores were associated with a decreased likelihood of death, after adjusting for age, performance and disease status.

CONCLUSION: The NFOSI-18 DRS-P scale is responsive to clinical change. It has potential as an indicator of changing health status with ovarian cancer disease progression, distinct from treatment side effects.

PMID:34548162 | DOI:10.1016/j.ygyno.2021.08.028

Fertil Steril. 2021 Sep 18:S0015-0282(21)01992-0. doi: 10.1016/j.fertnstert.2021.08.046. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the effect of preoperative intravenous (IV) acetaminophen versus oral (PO) acetaminophen or placebo on postoperative pain scores and the time to discharge in women undergoing oocyte retrieval.

DESIGN: Randomized, double-blind, placebo-controlled trial.

SETTING: Single academic fertility center.

PATIENT(S): Women aged 18-43 years undergoing oocyte retrieval.

INTERVENTION(S): Randomization to preoperative 1,000 mg IV acetaminophen and PO placebo (group A), IV placebo and 1,000 mg PO acetaminophen (group B), or IV and PO placebo (group C) MAIN OUTCOME MEASURE(S): Difference in patient-reported postoperative visual analog scale pain scores from baseline and the time to discharge.

RESULT(S): Of the 159 women who completed the study, there were no differences in the mean postoperative pain score differences or the time to discharge. Although not statistically significant, the mean postoperative opioid dose requirement in group A was lower than that in groups B and C (0.24 vs. 0.59 vs. 0.58 mg IV morphine equivalents, respectively) due to fewer women in group A requiring rescue pain medication (8% vs. 19% vs. 15%, respectively). Group A also reported less constipation when compared with groups B and C (19% vs. 33% vs. 40%, respectively). The rates of postoperative nausea were similar, and there were no differences in embryology or early pregnancy outcomes between the study groups.

CONCLUSION(S): Preoperative IV acetaminophen for women undergoing oocyte retrieval did not reduce postoperative pain scores or shorten the time to discharge when compared with PO acetaminophen or placebo and, thus, cannot currently be recommended routinely in this patient population.

CLINICAL TRIAL REGISTRATION NUMBER: NCT03073980.

PMID:34548165 | DOI:10.1016/j.fertnstert.2021.08.046

Syst Rev. 2021 Sep 21;10(1):253. doi: 10.1186/s13643-021-01806-2.

ABSTRACT

BACKGROUND: The upper respiratory tract of children is colonized by various microbial species during the healthy state, whereas the lungs are believed to be sterile. In children with respiratory infections, micro-organisms can be recovered from the upper respiratory sites, as well as the lungs. However, the correlation of microbial yield between the two sites is unclear. This systematic review is designed to explore the microbial composition of the respiratory system in healthy children, comparing the organisms identified in the upper airways versus the lungs. We will also compare the prevalence and pattern of upper respiratory micro-organisms in healthy children versus those with various respiratory diseases. We will additionally compare the organisms identified in the upper airway versus the lungs in children with respiratory disease.

METHODS: We will search the following electronic databases: Epistemonikos and Cochrane Library for systematic reviews and MEDLINE (through PubMed), EMBASE, Cochrane CENTRAL, LIVIVO, Web of Science, Scopus, and CINAHL databases for primary studies. Reference lists of relevant studies will be examined for links to potential related articles. Two reviewers will independently determine eligibility for inclusion. The methodological quality and risk of bias of the included observational studies will be scored using the Newcastle-Ottawa Scale tool, and JBI Critical Appraisal Checklist for case series. We will present the data with descriptive statistics and provide pooled estimates of outcomes, wherever it is feasible to perform a meta-analysis. Heterogeneity in studies will be explored by using the Higgins and Thompson I² method. Sensitivity analysis will be done to explore the impact of study quality, and subgroup analysis will be done based on age, health condition, type of respiratory specimen, and method of identifying organisms. We will prepare a summary of findings’ table and assess the confidence in the evidence using the GRADE methodology.

RESULTS: This is a protocol; hence, there are no results at this stage.

DISCUSSION: The proposed systematic review will provide comparisons of the microbiota in the upper respiratory tract versus the lungs, in children, during health as well as respiratory disease. Similarly, the site-specific yield will be compared between healthy children and those with respiratory disease. This will provide clinicians, microbiologists, and respiratory therapists a better understanding of the respiratory system microbiota, suitability (or otherwise) of upper airway specimens in various respiratory diseases, and the potential role of upper airway colonization on specific respiratory diseases. We will disseminate the review through a peer-reviewed journal publication. Data that cannot be included in the published version will be made available on request.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020202115 .

PMID:34548109 | DOI:10.1186/s13643-021-01806-2

Injury. 2021 Sep 12:S0020-1383(21)00757-9. doi: 10.1016/j.injury.2021.09.005. Online ahead of print.

ABSTRACT

BACKGROUND: Increasing numbers of patients are taking Direct Oral Anticoagulants at the time of hip fracture. Evidence is limited on how and if the effects of DOAC’s should be reversed before surgical fixation. Wide variations in practice exist. We conducted a systematic review to investigate outcomes for three reversal strategies. These were: “watch and wait” (also referred to as “time-reversal”), plasma product reversal and reversal with specific antidotes.

METHODS: A systematic search was conducted using multiple databases. Results were obtained for studies directly comparing different DOAC reversal strategies in hip fracture patients and for studies comparing DOAC-taking hip fracture patients (including patients “reversed” using any method and “non-reversed” patients) against matched controls taking either a vitamin-K antagonist or not receiving anticoagulation therapy. This allowed construction of a network meta-analysis to indirectly compare outcomes between “reversed” and “non-reversed” DOAC patients. With respect to “watch and wait”/”time-reversal”, a cut-off time to surgery of 36 hours was used to distinguish between “time-reversed” and “non time-reversed” DOAC patients. The primary outcome was early/inpatient mortality, reported as Odds Ratios (OR).

RESULTS: No studies investigating plasma products or reversal agents specifically in hip fracture patients were obtained. Fourteen studies were suitable for analysis of “watch and wait”/”time- reversal”. Two studies directly compared “time-reversed” and “non time-reversed” DOAC-taking hip fracture patients (58 “time-reversed”, 62 “non time-reversed”). From 12 other studies we used indirect comparisons between “time-reversed” and “non time-reversed” DOAC patients (total, 357 “time-reversed”, 282 “non time-reversed”). We found no statistically significant differences in mortality outcomes between “time-reversal” and “non time-reversal” (OR 1.48 [95%CI: 0.29-7.53]). We also did not find a statistically significant difference between “time reversal” and “non time-reversal” in terms of blood transfusion requirements (OR 1.16 [95% CI 0.42-3.23]). However, several authors described that surgical delay is associated with worse outcomes related to prolonged hospitalisation, and that operating within 36 hours is safe.

CONCLUSIONS: We suggested against “watch and wait” to reverse the DOAC effect in hip fractures. Further work is required to assess the optimal timing for surgery as well as the use of plasma products or specific antidotes in DOAC-taking hip fracture patients.

PMID:34548147 | DOI:10.1016/j.injury.2021.09.005

Parasit Vectors. 2021 Sep 21;14(1):484. doi: 10.1186/s13071-021-04996-9.

ABSTRACT

This letter responds to comments on our article (Yin YL et al., Parasit Vectors, 10.1186/s13071-021-04739-w) by Yuqing Wang and colleagues, who wrote a letter entitled “Microarray analysis of circular RNAs in HCT-8 cells infected with Cryptosporidium parvum” and discussed statistical procedures for microarray analysis during C. parvum infection. To further confirm our data, in this letter, a common R package for analyses of differentially expressed genes, namely DESeq2, with Benjamini-Hochberg correction, was used to analyze our microarray data and identified 26 significantly differentially expressed circRNAs using adjusted P value < 0.05 and | Log₂ (fold change [FC]) | ≥ 1.0, including our circRNA ciRS-7 of interest. Therefore, the protocol for selecting circRNAs of interest for further study in our article is acceptable and did not affect the subsequent scientific findings in our article.

PMID:34548103 | DOI:10.1186/s13071-021-04996-9

Parasit Vectors. 2021 Sep 21;14(1):485. doi: 10.1186/s13071-021-04957-2.

ABSTRACT

We read with great interest the article by Yin et al. (Parasit Vectors 14:238, 2021). The authors found that Cryptosporidium infection induced significantly aberrant expression of circular RNA profiles in HCT-8 cells, a finding which has far-reaching implications. However, due to the high number of false positives caused by multiple comparisons, statistical methods for microarray analysis should be carefully selected. Accurate analysis results will provide a convincing basis for subsequent experiments. In addition, we recommend several more appropriate methods in this article.

PMID:34548105 | DOI:10.1186/s13071-021-04957-2

World J Surg Oncol. 2021 Sep 21;19(1):285. doi: 10.1186/s12957-021-02343-x.

ABSTRACT

OBJECTIVE: To investigate the effect of Helicobacter pylori (H. pylori) eradication on the prognosis of postoperative early gastric cancer (EGC).

METHODS: This is a retrospective study based on data from 6 hospitals. We identified 429 patients with EGC who underwent curative gastrectomy from January 2010 to December 2016. All of the patients were tested for H. pylori. Patients were divided into two groups, the successful H. pylori eradication group (group A, 268 patients) and the non-H. pylori eradication group (group B, 161 patients), for calculating the disease-free survival (DFS) and overall survival (OS) of each group.

RESULT: Positive node metastasis (hazard ratio (HR), 3.13; 95% confidence interval (CI), 1.84-5.32; P < 0.001), undifferentiated type (HR, 2.54; 95% CI, 1.51-4.28; P < 0.001), and non-H. pylori eradication (HR, 1.73; 95% CI, 1.08-2.77; P = 0.023) were statistically significantly independent risk factors of recurrence. Patient’s age ≥60 years old (HR, 3.32; 95% CI, 2.00-5.53; P < 0.001), positive node metastasis (HR, 3.71; 95% CI, 2.25-6.12; P < 0.001), undifferentiated type (HR, 3.06; 95% CI, 1.79-5.23; P < 0.001), and non-H. pylori eradication (HR, 1.83; 95% CI, 1.11-3.02; P = 0.018) were statistically significantly independent risk factors of overall survival.

CONCLUSION: H. pylori eradication treatment could prevent the recurrence of postoperative EGC to prolong the overall survival of patients with EGC.

PMID:34548086 | DOI:10.1186/s12957-021-02343-x