Category: Statistics

BMJ Open. 2021 Aug 5;11(8):e049768. doi: 10.1136/bmjopen-2021-049768.

ABSTRACT

INTRODUCTION: Alzheimer’s disease has a high prevalence and a substantial impact on society, as well as the individual. Findings from clinical studies to date, suggest that multiple factors are likely to contribute to the variability seen in the progression of Alzheimer’s disease. However, despite this accumulating evidence, current identified factors do not explain the full extent of disease onset. Thus, the role of additional factors needs to be explored further.One such factor is exposure to adverse childhood experiences. However, the degree of this association is unknown. This systematic review will examine the literature investigating the associations between adverse childhood experiences and the risk of Alzheimer’s disease.

METHODS AND ANALYSIS: Articles investigating associations between exposure to adverse childhood experiences and the risk of Alzheimer’s disease will be identified systematically by searching CINAHL, MEDLINE and PsycInfo using Ebscohost. No restrictions on date of publication will be applied. The search strategy will be built combining the main key elements of the Population, Exposure, Comparator, and Outcomes inclusion criteria. A meta-analysis is planned and statistical methods will be used to identify and control for heterogeneity, if possible. The development of this protocol was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols.

ETHICS AND DISSEMINATION: Only published data will be used for this study, thus, ethical approval will not be required. Findings of the review will be published in a peer-reviewed scientific journal, and presented at national and international conferences.

PROSPERO REGISTRATION NUMBER: CRD42020191439.

PMID:34353804 | DOI:10.1136/bmjopen-2021-049768

BMJ Open. 2021 Aug 5;11(8):e050448. doi: 10.1136/bmjopen-2021-050448.

ABSTRACT

INTRODUCTION: Research has shown that improvements to the usability of medication alert systems are needed. For designers and decisions-makers to assess usability of their alert systems, two paper-based tools are currently available: the instrument for evaluating human-factors principles in medication-related decision support alerts (I-MeDeSA) and the tool for evaluating medication alerting systems (TEMAS). This study aims to compare the validity, usability and usefulness of both tools to identify their strengths and limitations and assist designers and decision-makers in making an informed decision about which tool is most suitable for assessing their current or prospective system.

METHODS AND ANALYSIS: First, TEMAS and I-MeDeSA will be translated into French. This translation will be validated by three experts in human factors. Then, in 12 French hospitals with a medication alert system in place, staff with expertise in the system will evaluate their alert system using the two tools successively. After the use of each tool, participants will be asked to fill in the System Usability Scale (SUS) and complete a survey on the understandability and perceived usefulness of each tool. Following the completion of both assessments, participants will be asked to nominate their preferred tool and relay their opinions on the tools. The design philosophy of TEMAS and I-MeDeSA differs on the calculation of a score, impacting the way the comparison between the tools can be performed. Convergent validity will be evaluated by matching the items of the two tools with respect to the usability dimensions they assess. SUS scores and answers to the survey will be statistically compared for I-MeDeSA and TEMAS to identify differences. Free-text responses in surveys will be analysed using an inductive approach.

ETHICS AND DISSEMINATION: Ethical approval is not required in France for a study of this nature. The results will be published in a peer-reviewed journal.

PMID:34353806 | DOI:10.1136/bmjopen-2021-050448

BMJ Open. 2021 Aug 5;11(8):e044070. doi: 10.1136/bmjopen-2020-044070.

ABSTRACT

INTRODUCTION: Rheumatic heart diseases (RHDs) contribute significant morbidity and mortality globally. To reduce the burden of RHD, timely initiation of secondary prophylaxis is important. The objectives of this study are to determine the frequency of subclinical RHD and to train a deep learning (DL) algorithm using waveform data from the digital auscultatory stethoscope (DAS) in predicting subclinical RHD.

METHODS AND ANALYSIS: We aim to recruit 1700 children from a group of schools serving the underprivileged over a 12-month period in Karachi (Pakistan). All consenting students within the age of 5-15 years with no underlying congenital heart disease will be eligible for the study. We will gather information regarding sociodemographics, anthropometric data, history of symptoms or diagnosis of rheumatic fever, phonocardiogram (PCG) and electrocardiography (ECG) data obtained from DAS. Handheld echocardiogram will be performed on each study participant to assess the presence of a mitral regurgitation (MR) jet (>1.5 cm), or the presence of aortic regurgitation (AR) in any view. If any of these findings are present, a confirmatory standard echocardiogram using the World Heart Federation (WHF) will be performed to confirm the diagnosis of subclinical RHD. The auscultatory data from digital stethoscope will be used to train the deep neural network for the automatic identification of patients with subclinical RHD. The proposed neural network will be trained in a supervised manner using labels from standard echocardiogram of the participants. Once trained, the neural network will be able to automatically classify the DAS data in one of the three major categories-patient with definite RHD, patient with borderline RHD and normal subject. The significance of the results will be confirmed by standard statistical methods for hypothesis testing.

ETHICS AND DISSEMINATION: Ethics approval has been taken from the Aga Khan University, Pakistan. Findings will be disseminated through scientific publications and to collaborators.

ARTICLE FOCUS: This study focuses on determining the frequency of subclinical RHD in school-going children in Karachi, Pakistan and developing a DL algorithm to screen for this condition using a digital stethoscope.

PMID:34353792 | DOI:10.1136/bmjopen-2020-044070

Arch Plast Surg. 2021 Jul;48(4):417-426. doi: 10.5999/aps.2020.02089. Epub 2021 Jul 15.

ABSTRACT

BACKGROUND: Soft tissue coverage plays a vital role in replacing the vascularity of the underlying bone in Gustilo type IIIB fractures. The aim of this article was to evaluate the feasibility of local pedicled flaps in type IIIB fractures at a tertiary care center.

METHODS: We included all cases of open Gustilo-Anderson type IIIB fractures of the tibia treated with local flap coverage from January 2017 to February 2019. We carried out a retrospective analysis to investigate the relationships of complications, hospital stay, and cost-effectiveness with the choice of flap, infective foci, site and size of the defect, and type of fixation.

RESULTS: Out of 138 Gustilo type IIIB fractures analyzed in our study, 27 cases had complications, of which 19 (13.76%) involved flap necrosis, four (2.89%) were infections, three (2.17%) involved partial necrosis, and one (0.72%) was related to bone spur development. Flap complications showed a statistically significant association with the perforator flap category (propeller flaps in particular) (P=0.001). Flap necrosis showed a significant positive correlation with cases treated within 3 weeks after trauma (P=0.046). A significant positive correlation was also found between defect size and the duration of hospital stay (P=0.03).

CONCLUSIONS: Although local flaps are harvested from the same leg that underwent trauma, their success rate is at least as high as microvascular flaps as reported from other centers. Amidst the local flaps, complications were predominantly associated with perforator flaps.

PMID:34352955 | DOI:10.5999/aps.2020.02089

Arch Plast Surg. 2021 Jul;48(4):433-439. doi: 10.5999/aps.2020.02306. Epub 2021 Jul 15.

ABSTRACT

Acellular dermal matrices (ADM) are a novel graft. The goal of this systematic review is to evaluate the evidence behind differences in human and porcine ADM, irrelevant of manufacturing method, and to determine if there is enough of an evidence base to change clinical practice. An extensive literature search was performed through MEDLINE and Embase with search terms defining a population, intervention and outcome. Title and abstract exclusion were performed with other exclusion criteria. In 191 articles were found after exclusion of duplicates, with only 29 remaining following exclusions. Ten studies were found to have level I and II evidence (I=3, II=8), of which two were histopathological, one was an animal model, one was a systematic review, and six were clinical. The remaining studies were reviewed and considered for discussion, but did not hold high enough standards for medical evidence. Strong clinical evidence already exists for the use of human ADM, but questions of access, cost, and ethics require consideration of a xenograft. Histopathologically, evidence suggests minimal long-term differences between human and porcine ADM, although there is a short acute immune response with porcine ADM. Clinically, there is limited difference in outcomes, with a small range in effect of different ADM preparations. Considering the effectiveness of ADM in wound healing, more high-level research with appropriate statistical analysis to facilitate a future meta-analysis is recommended to justify a transition from human to porcine ADM.

PMID:34352957 | DOI:10.5999/aps.2020.02306

Surg Technol Int. 2021 Aug 5;39:sti39/1470. Online ahead of print.

ABSTRACT

INTRODUCTION: Prior publications have demonstrated chemical and physical alteration of hernia mesh analyzed after explantation from the body. The specific alteration documented is oxidative degradation of polypropylene mesh fibers. An animal study recently published has demonstrated that adipose tissue attachment is present instead of reparative fibrous tissue infiltration in an average of 10.9-18.9% of the intramesh healing for a variety of clinically used knitted polypropylene mesh products; 8.0% for knitted polyester meshes. This study also found that in comparison to the knitted mesh products, non-woven polypropylene mesh reduced adipose tissue attachment to 1% or less, which was a statistically significant difference.

MATERIALS AND METHODS: Samples of explanted polypropylene mesh from eight patients were analyzed for the presence of adipose tissue attachment, reparative fibrous tissue infiltration, and oxidative changes. Greater adipose tissue attachment areas were compared with areas of greater reparative fibrous tissue infiltration for evidence of oxidative changes in the mesh to determine if the areas of higher adipose tissue attachment correlated with an increase in oxidative changes.

RESULTS: Intra mesh healing of clinically explanted knitted meshes demonstrated adipose tissue content from 0.0% to 49.1% per analyzed segment. The oxidation index, a measure of the degree of oxidative degradation in that portion of the mesh, was higher in seven of the eight areas of greater adipose tissue attachment than areas of greater reparative fibrous tissue infiltration.

CONCLUSION: Adipose tissue attachment does occur in knitted and woven polypropylene hernia meshes. The presence of adipose tissue may contribute to an increase in oxidative changes in knitted polypropylene hernia mesh fibers.

PMID:34352925

Arch Plast Surg. 2021 Jul;48(4):366-372. doi: 10.5999/aps.2020.02152. Epub 2021 Jul 15.

ABSTRACT

BACKGROUND: The result of illicit polymer injection is chronic inflammation with foreign-body granuloma (FBG) formation. Treatment can be divided into medical and surgical. Some patients develop severe complications with need surgical treatment. This study aims to describe patients who underwent surgical removal of the FBGs and autoimmune/inflammatory syndrome induced by adjuvants (ASIA); additionally, we evaluated the quality of life after surgery.

METHODS: In this retrospective single-center study, the authors examined data of patients who underwent surgical removal of FBG caused by illicit polymer injection for cosmetic purposes and confirmed ASIA from 2015 to 2020 by three different surgical approaches. Descriptive summary statistics were reported on patient demographics, presenting symptoms and clinical examination features, treatment strategies, histopathology reports and quality of life.

RESULTS: The cohort included 11 female patients with FBGs and ASIA. The most affected anatomical zones were the combination of gluteal region, thighs and legs (40%); and thighs with legs (20%). Main presentation was: skin hyperpigmentation (90.9%), skin induration (63.6%), chronic fatigue (63.6%), and ulcers (36.4%). Surgical modalities consisted of: ultrasonic-assisted liposuction in four patients (36.4%); open en bloc excision and primary closure in four patients (36.4%); and open en bloc excision and microsurgical reconstruction in three patients (27.2%). The postoperative quality of life visual analog scale score was 83.9.

CONCLUSIONS: ASIA treatment represents a challenge for the plastic surgeon. Adequate surgical treatment emphasizing, when possible, the total or near-total resection of the FBG must be performed to improve ASIA evolution.

PMID:34352946 | DOI:10.5999/aps.2020.02152

Adv Nutr. 2021 Aug 5:nmab093. doi: 10.1093/advances/nmab093. Online ahead of print.

ABSTRACT

High-glycemic index (high-GI) foods (so-called fast carbs) have been hypothesized to promote fat storage and increase risk of obesity. To clarify whether dietary GI impacts body weight, we searched PubMed and the Cochrane Database of Systematic Reviews for observational studies reporting associations between BMI and dietary GI, and for meta-analyses of randomized controlled trials (RCTs) comparing low-GI and high-GI diets for weight loss. Data on 43 cohorts from 34 publications, totaling 1,940,968 adults, revealed no consistent differences in BMI when comparing the highest with the lowest dietary GI groups. In the 27 cohort studies that reported results of statistical comparisons, 70% showed that BMI was either not different between the highest and lowest dietary GI groups (12 of 27 cohorts) or that BMI was lower in the highest dietary GI group (7 of 27 cohorts). Results of 30 meta-analyses of RCTs from 8 publications demonstrated that low-GI diets were generally no better than high-GI diets for reducing body weight or body fat. One notable exception is that low-GI diets with a dietary GI at least 20 units lower than the comparison diet resulted in greater weight loss in adults with normal glucose tolerance but not in adults with impaired glucose tolerance. While carbohydrate quality, including GI, impacts many health outcomes, GI as a measure of carbohydrate quality appears to be relatively unimportant as a determinant of BMI or diet-induced weight loss. Based on results from observational cohort studies and meta-analyses of RCTs, we conclude that there is scant scientific evidence that low-GI diets are superior to high-GI diets for weight loss and obesity prevention.

PMID:34352885 | DOI:10.1093/advances/nmab093

Am J Perinatol. 2021 Aug 5. doi: 10.1055/s-0041-1732379. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to evaluate maternal and neonatal outcomes by method of cervical ripening for labor induction among low-risk nulliparous individuals.

STUDY DESIGN: This is a secondary analysis of a multicenter randomized trial of labor induction at 39 weeks versus expectant management in low-risk nulliparous participants. Participants undergoing cervical ripening for labor induction in either group were included. Participants were excluded for preripening membrane rupture, abruption, chorioamnionitis, fetal demise, or cervical dilation ≥3.5 cm. Cervical ripening was defined by the initial method used: prostaglandin only (PGE; referent), Foley with concurrent prostaglandin (Foley-PGE), Foley only (Foley), and Foley with concurrent oxytocin (Foley-oxytocin). Coprimary outcomes were adverse maternal and neonatal composites. Secondary outcomes included cesarean delivery and length of labor and delivery (L&D) stay. Multivariable analysis was used to adjust for patient characteristics.

RESULTS: Of 6,106 participants included in the trial, 2,376 (38.9%) met criteria for this analysis. Of these, 1,247 (52.4%) had cervical ripening with PGE, 290 (12.2%) had Foley-PGE, 385 (16.2%) had Foley, and 454 (19.1%) had Foley-oxytocin. The maternal composite outcome was similar among participants who received Foley-PGE (24.1%, adjusted relative risk [aRR] = 1.21, 95% confidence interval [CI]: 0.96-1.52), Foley (21.3%, aRR = 1.16, 95% CI: 0.92-1.45), or Foley-oxytocin (19.4%, aRR = 1.04, 95% CI: 0.83-1.29), compared with PGE (19.7%). The neonatal composite outcome was less frequent in participants who received the Foley-PGE (2.4%, aRR = 0.35, 95% CI: 0.16-0.75) or Foley (3.6%, aRR = 0.51, 95% CI: 0.29-0.89) but did not reach statistical significance for participants who received Foley-oxytocin (4.6%, aRR = 0.63, 95% CI: 0.40-1.01) compared with PGE only (6.8%). Participants who received Foley-PGE or Foley-oxytocin had a shorter L&D stay (adjusted mean difference = -1.97 hours, 95% CI: -3.45 to -0.49 and -5.92 hours, 95% CI: -7.07 to -4.77, respectively), compared with PGE.

CONCLUSION: In term low-risk nulliparous participants, Foley alone or concurrent with PGE is associated with a lower risk of adverse neonatal outcomes than with PGE alone. Length of L&D stay was the shortest with concurrent Foley-oxytocin.

KEY POINTS: · Adverse maternal outcomes are similar among different methods of cervical ripening in low-risk women.. · Adverse neonatal outcomes are less frequent with use of Foley alone or in combination with PGE.. · The use of Foley alone, or in combination with other agents, appears to be beneficial..

PMID:34352922 | DOI:10.1055/s-0041-1732379

Am J Perinatol. 2021 Aug 5. doi: 10.1055/s-0041-1733784. Online ahead of print.

ABSTRACT

OBJECTIVE: Retosiban, an oxytocin receptor antagonist, was developed for treating spontaneous preterm labor (sPTL) in women with intact membranes. This ARIOS follow-up study aimed to characterize clinical safety, morbidity, and mortality of infants exposed to retosiban or comparator over 2 years.

STUDY DESIGN: ARIOS prospectively assessed outcomes in infants whose mothers received at least one dose of retosiban or comparator (placebo/atosiban) in two Phase 3 sPTL trials. Both trials were terminated prematurely owing to poor enrolment. Infants could be enrolled into ARIOS from 28 days after estimated due date until hospital discharge or up to 9 months (corrected age). An internally developed questionnaire detailing medical conditions, mortality and resource use (Child Health Inventory; CHI), Ages and Stages Questionnaire-3 (ASQ-3), Modified Checklist for Autism in Toddlers-Revised with Follow-Up, and Child Behavior Checklist for Ages 1.5 to 5 were completed remotely by parents or legal guardians at prespecified intervals. Serious adverse events (SAEs) were primarily captured via CHI. No comparative statistical analysis was conducted between treatment arms.

RESULTS: A total of 49 (86%) infants who had received retosiban and 49 (78%) infants who had received a comparator were enrolled in ARIOS. No deaths occurred during the study. Nine infants experienced SAEs: 6/49 (12.2%) infants in the comparators group and 3/49 (6.1%) in the retosiban group. Of the nine SAEs, seven were due to infections, three, and four in the retosiban and comparators groups, respectively. Based on ASQ-3 score, the incidence of neurodevelopmental delay at 18 and 24 months were 0/18 (0%) and 2/25 (8%) with retosiban and 7/22 (31.8%) and 3/21 (14.3%) with comparator, respectively.

CONCLUSION: The current study showed no unexpected adverse outcome or impairment with retosiban based on safety monitoring and neurodevelopment assessments. No further follow-up is intended owing to the discontinuation of clinical development of retosiban.

KEY POINTS: · There is a need for an effective and safe treatment for sPTL.. · ARIOS was a follow-up study of two Phase 3 trials in sPTL.. · There were no safety concerns with retosiban treatment.. · Slow recruitment led to termination of the Phase 3 trials..

PMID:34352924 | DOI:10.1055/s-0041-1733784