Nevin Manimala

J Pediatr Surg. 2021 May 24:S0022-3468(21)00387-0. doi: 10.1016/j.jpedsurg.2021.05.011. Online ahead of print.

ABSTRACT

AIM: To evaluate the correlation between sacral/vertebral anomalies and spinal cord anomalies (SCA) on MRI, in patients with anorectal malformation (ARM).

METHODS: Patients with ARM consecutively treated between January 1999 and August 2019 were included. Radiological imaging of sacrum and spine were retrospectively analyzed and correlated to the presence of SCA at MRI. Fisher’s exact test and X² test were used as appropriate; p<0.05 was considered statistically significant.

RESULTS: 348 patients with ARM were enrolled in the study, 147 presented SCA at MRI. 144 patients showed spinal bone anomalies, isolated vertebral and sacral anomalies were found in 17,6% and 35% respectively. Higher level of ARM was associated with a significant higher prevalence of sacral and vertebral anomalies. A significant correlation was found between the “level” of ARM and the presence of SCA (p<0.05). Sacral anomalies were significantly correlated with the presence of SCA at MRI (p<0.05). SCA were found in 70% of patients with vertebral anomalies (VA) and in 76% of patients with sacral anomalies. The presence of multiple malformations (vertebral and sacral anomalies) are strictly related to the presence of SCA. However, the absence of spinal bone anomalies does not exclude the presence of SCA. SD was the most represented type of SCA (n=94/147), of those 96% had fatty filum. Neurological or neurourological symptoms were detected in 11,5% patients (n=17) with SCA and required neurosurgical intervention.

CONCLUSIONS: Our data confirm the strong relation between sacral or vertebral anomalies and SCA. However, in our series also patients without sacral/vertebral anomalies had SCA at MRI. Our results suggest that, despite the presence or absence of spinal anomalies, spinal cord MRI should be performed in all children with ARM, to allow a correct multidisciplinary follow-up and treatment. In fact, most patients with spinal bone and SCA are asymptomatic, but could develop clinical manifestations during their growth.

PMID:34167803 | DOI:10.1016/j.jpedsurg.2021.05.011

J Pediatr Surg. 2021 Jun 1:S0022-3468(21)00428-0. doi: 10.1016/j.jpedsurg.2021.05.019. Online ahead of print.

ABSTRACT

BACKGROUND: Victims of child physical abuse (CPA) undergo stabilization and social evaluation during initial management. Current data guides the initial hospital course, but few studies evaluate post-hospital care. The aim of this study was to evaluate compliance with recommended post-discharge visits.

METHODS: A retrospective review of our trauma database at a Level I pediatric trauma center from 2014-2018 was performed. Data included demographics, injuries, and longitudinal outcomes. Descriptive statistics and univariate analyses were performed.

RESULTS: There were 401 patients (409 unique presentations). Median age was 7 months. Mortality was 6%. Ninety-five percent (358/377) had recommended appointments with multiple specialty services. Compliance with all recommended visits during the first year after injury was 88%. Patients with complex injuries were as likely to comply with recommended follow-up [72% vs. 67%, p = 0.4]; however, they were more likely to still be receiving care at 1 year (58% vs. 14%, p = 0.0001). Those discharged to CPS custody were more likely to be compliant with their follow-up (90% vs. 82%, p = 0.03).

CONCLUSION: Patients significantly injured due to CPA require more post-hospital care over time. CPA management guidelines should include a mechanism to provide resources to these patients and manage multiple coordinating consultants .

PMID:34167802 | DOI:10.1016/j.jpedsurg.2021.05.019

Nefrologia. 2021 Mar-Apr;41(2):200-209. doi: 10.1016/j.nefroe.2020.12.005. Epub 2021 May 24.

ABSTRACT

BACKGROUND AND OBJECTIVE: The number of patients who start dialysis due to graft failure increases every day. The best dialysis modality for this type of patient is not well defined and most patients are referred to HD. The objective of our study is to evaluate the impact of the dialysis modality on morbidity and mortality in transplant patients who start dialysis after graft failure.

MATERIAL AND METHODS: A multicentre retrospective observation and cohort study was performed to compare the evolution of patients who started dialysis after graft failure from January 2000 to December 2013. One group started on PD and the other on HD. The patients were followed until the change of dialysis technique, retransplantation or death. Anthropometric data, comorbidity, estimated glomerular filtration rate (eGFR) at start of dialysis, the presence of an optimal access for dialysis, the appearance of graft intolerance and retransplantation were analyzed. We studied the causes for the first 10 hospital admissions after starting dialysis. For the statistical analysis, the presence of competitive events that hindered the observation of the event of interest, death or hospital admission was analyzed.

RESULTS: 175 patients were included, 86 in DP and 89 in HD. The patients who started PD were younger, had less comorbidity and started dialysis with lower eGFR than those on HD. The mean follow-up was 34 ± 33 months, with a median of 24 months (IQR 7-50 months), Patients on HD had longer follow-up than patients on PD (35 vs. 18 months, p = < 0.001). The mortality risk factors were age sHR 1.06 (95% CI: 1.03-1.106, p = 0.000), non-optimal use of access for dialysis sHR 3.00 (95% CI: 1.507-5.982, p = 0.028) and the dialysis modality sHR (PD/HD) 0.36 (95% CI: 0.148-0.890, p = 0.028). Patients on PD had a lower risk of hospital admission sHR [DP/HD] 0.52 (95% CI: 0.369-0.743, p = < 0.001) and less probability of developing graft intolerance HR 0.307 (95% CI 0.142-0.758, p = 0.009).

CONCLUSIONS: With the limitations of a retrospective and non-randomized study, it is the first time nationwide that PD shows in terms of survival to be better than HD during the first year and a half after the kidney graft failure. The presence of a non-optimal access for dialysis was an independent and modifiable risk factor for mortality. Early referral of patients to advanced chronic kidney disease units is essential for the patient to choose the technique that best suits their circumstances and to prepare an optimal access for the start of dialysis.

PMID:34167773 | DOI:10.1016/j.nefroe.2020.12.005

Lancet Digit Health. 2021 Jul;3(7):e445-e454. doi: 10.1016/S2589-7500(21)00082-0.

ABSTRACT

BACKGROUND: Biparametric MRI (comprising T2-weighted MRI and apparent diffusion coefficient maps) is increasingly being used to characterise prostate cancer. Although previous studies have combined Prostate Imaging-Reporting & Data System (PI-RADS)-based MRI findings with routinely available clinical variables and with deep learning-based imaging predictors, respectively, for prostate cancer risk stratification, none have combined all three. We aimed to construct an integrated nomogram (referred to as ClaD) combining deep learning-based imaging predictions, PI-RADS scoring, and clinical variables to identify clinically significant prostate cancer on biparametric MRI.

METHODS: In this retrospective multicentre study, we included patients with prostate cancer, with histopathology or biopsy reports and a screening or diagnostic MRI scan in the axial view, from four cohorts in the USA (from University Hospitals Cleveland Medical Center, Icahn School of Medicine at Mount Sinai, Cleveland Clinic, and Long Island Jewish Medical Center) and from the PROSTATEx Challenge dataset in the Netherlands. We constructed an integrated nomogram combining deep learning, PI-RADS score, and clinical variables (prostate-specific antigen, prostate volume, and lesion volume) using multivariable logistic regression to identify clinically significant prostate cancer on biparametric MRI. We used data from the first three cohorts to train the nomogram and data from the remaining two cohorts for independent validation. We compared the performance of our ClaD integrated nomogram with that of integrated nomograms combining clinical variables with either the deep learning-based imaging predictor (referred to as DIN) or PI-RADS score (referred to as PIN) using area under the receiver operating characteristic curves (AUCs). We also compared the ability of the nomograms to predict biochemical recurrence on a subset of patients who had undergone radical prostatectomy. We report cross-validation AUCs as means for the training set and used AUCs with 95% CIs to assess the performance on the test set. The difference in AUCs between the models were tested for statistical significance using DeLong’s test. We used log-rank tests and Kaplan-Meier curves to analyse survival.

FINDINGS: We investigated 592 patients (823 lesions) with prostate cancer who underwent 3T multiparametric MRI at five hospitals in the USA between Jan 8, 2009, and June 3, 2017. The training data set consisted of 368 patients from three sites (the PROSTATEx Challenge cohort [n=204], University Hospitals Cleveland Medical Center [n=126], and Icahn School of Medicine at Mount Sinai [n=38]), and the independent validation data set consisted of 224 patients from two sites (Cleveland Clinic [n=151] and Long Island Jewish Medical Center [n=73]). The ClaD clinical nomogram yielded an AUC of 0·81 (95% CI 0·76-0·85) for identification of clinically significant prostate cancer in the validation data set, significantly improving performance over the DIN (0·74 [95% CI 0·69-0·80], p=0·0005) and PIN (0·76 [0·71-0·81], p<0·0001) nomograms. In the subset of patients who had undergone radical prostatectomy (n=81), the ClaD clinical nomogram resulted in a significant separation in Kaplan-Meier survival curves between patients with and without biochemical recurrence (HR 5·92 [2·34-15·00], p=0·044), whereas the DIN (1·22 [0·54-2·79], p=0·65) and PIN nomograms did not (1·30 [0·62-2·71], p=0·51).

INTERPRETATION: Risk stratification of patients with prostate cancer using the integrated ClaD nomogram could help to identify patients with prostate cancer who are at low risk, very low risk, and favourable intermediate risk, who might be candidates for active surveillance, and could also help to identify patients with lethal prostate cancer who might benefit from adjuvant therapy.

FUNDING: National Cancer Institute of the US National Institutes of Health, National Institute for Biomedical Imaging and Bioengineering, National Center for Research Resources, US Department of Veterans Affairs Biomedical Laboratory Research and Development Service, US Department of Defense, US National Institute of Diabetes and Digestive and Kidney Diseases, The Ohio Third Frontier Technology Validation Fund, Case Western Reserve University, Dana Foundation, and Clinical and Translational Science Collaborative.

PMID:34167765 | DOI:10.1016/S2589-7500(21)00082-0

Endocrinol Diabetes Nutr (Engl Ed). 2021 Mar;68(3):170-174. doi: 10.1016/j.endien.2021.06.001. Epub 2021 Jun 16.

ABSTRACT

OBJECTIVE: To show that statistical techniques allow for obtaining a reduced number of four-hour glucose profiles that can identify any glucose behavior in patients with type 1 diabetes mellitus.

PATIENTS AND METHODS: A retrospective study of 10 patients with type 1 diabetes mellitus was conducted using data collected by continuous glucose monitoring. A data mining technique based on decision trees called CHAID (Chi-square Automatic Interaction Detection) was used to classify glucose profiles into groups using two decision criteria. These were 1, the seven days of the week and 2, different time slots, the day being divided into six sections of four hours each. Clustering was performed according to the glucose levels recorded using the statistically significant differences found.

RESULTS: Significant differences (P-value <.05) and dependencies were seen between the glucose profiles classified depending on the independent variables ‘day of the week’ and ‘time slot’. The relationships found were different for each patient, showing the need for individualized studies.

CONCLUSIONS: The results obtained will facilitate mathematical modeling of glucose, and can be used to develop an individualized classifier for each patient that categorizes glucose profiles based on the day of the week and time slot variables. Using this classifier, it will be possible to predict the glucose levels of the patient knowing on which day of the week and in which time slot he/she is, leading to more precise models. Healthcare professionals will also be able to improve patient habits and therapies.

PMID:34167696 | DOI:10.1016/j.endien.2021.06.001

Am J Cardiol. 2021 Jul 15;151:64-69. doi: 10.1016/j.amjcard.2021.04.017.

ABSTRACT

Despite significant advances in evidence-based treatments for heart failure with reduced ejection fraction (HFrEF), the use of guideline directed medical therapy (GDMT) at recommended doses remains suboptimal. We examine the usage and modification of inpatient GDMT and its effect on outcomes in patients hospitalized with a diagnosis of acute on chronic HFrEF between 2013 and 2018. Overall use and modification of GDMT, which included heart failure appropriate beta-blockers (BB), renin-angiotensin system inhibitors (RASi) and aldosterone blockers (MRA) during the hospitalization were collected. Target dosages were based on guideline recommendations. Primary endpoints included 30-day hospitalization-free survival and 1-year survival. Among 1,655 patients, discharge use of BB, RASi, and MRA was 73.4%, 55.9% and 13.8%, respectively. Upon discharge, ≥50% target dose of BB, RASi, and MRA was used in 25.3%, 15.6%, and 13.7%, respectively. In multivariable analyses, there was a statistically significant improvement in 1-year survival and 30-day hospitalization-free survival in patients discharged on increasing number of medication classes optimized at ≥50% target dose (per extra medication, HR 0.74, 0.64-0.86, p <0.001, and HR 0.73, 0.62-0.86, p = 0.0002), respectively. Initiation and/or uptitration of BB and RASi was associated with improved 30-day hospitalization-free survival and 1-year survival, (HR 0.73 (0.57-0.92), p = 0.0087; HR 0.62 (0.46-0.82), p <0.001) for BB and (HR 0.77 (0.62-0.95), p <0.001; HR 0.62 (0.48-0.80), p <0.001) for RASi, respectively. In conclusion, inpatient optimization of GDMT in acute HFrEF is feasible and associated with improved 30-day hospitalization-free survival and 1-year survival.

PMID:34167690 | DOI:10.1016/j.amjcard.2021.04.017

Health Technol Assess. 2021 Jun;25(41):1-110. doi: 10.3310/hta25410.

ABSTRACT

BACKGROUND: Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents’ dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults.

OBJECTIVE: To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment.

DESIGN: A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial.

SETTING: A total of 37 UK residential and nursing care homes.

PARTICIPANTS: Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance.

INTERVENTIONS: Residents were randomised (1 : 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period.

MAIN OUTCOME MEASURES: Primary outcome – change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes – number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use.

RESULTS: A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197; sham stimulation, n = 209); two exclusions occurred post randomisation. Primary outcome data were available for 345 (85%) residents (transcutaneous posterior tibial nerve stimulation, n = 167; sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78% of the transcutaneous posterior tibial nerve stimulation group and 71% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of -5 ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and -66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95% confidence interval 0 to 136 ml; p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants’ scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures.

CONCLUSIONS: The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost-consequences analysis; however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context.

LIMITATIONS: Completing 24-hour pad collections was challenging for care home staff, resulting in some missing primary outcome data.

FUTURE WORK: Research should investigate transcutaneous posterior tibial nerve stimulation in residents with urgency urinary incontinence to determine whether or not targeted stimulation is effective. Research should evaluate the effects of continence training for staff on continence care in care homes.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN98415244 and ClinicalTrials.gov NCT03248362.

FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 41. See the NIHR Journals Library website for further project information.

PMID:34167637 | DOI:10.3310/hta25410

Br J Nutr. 2021 Jun 25:1-33. doi: 10.1017/S000711452100235X. Online ahead of print.

ABSTRACT

This work investigated the effects of repeated sweet taste exposure at breakfast on perceptions and intakes of other sweet foods, while also examining effects due to duration of exposure (1/3 weeks), test context (breakfast/lunch), and associations between taste perceptions and intakes. Using a randomised controlled parallel-groups design, participants (N=54, 18 male, mean age: 23.9±5.8yrs, mean BMI: 23.6±3.5kg/m2) were randomized to consume either a sweet breakfast (cereal with sucralose) (N=27) or an equicaloric non-sweet breakfast (plain cereal) (N=27) for 3 weeks. On days 0 (baseline), 7, and 21, pleasantness, desire to eat and sweetness were rated for other sweet and non-sweet foods, and sweet food consumption was assessed in an ad-libitum meal at breakfast and lunch. Using intention-to-treat analyses, no statistically significant effects of exposure were found at breakfast (largest F(2,104)=1.84, p=0.17, ηp2=0.03), or lunch (largest F(1,52)=1.22, p=0.27, ηp2=0.02), and using Bayesian analyses, the evidence for an absence of effect in all rating measures was strong to very strong (smallest BF01=297.97 (BF01error=2.68%)). Associations between ratings of pleasantness, desire to eat and intake were found (smallest r=0.137, p<0.01). Effects over time regardless of exposure were also found: sugars and percent energy consumed from sweet foods increased throughout the study smallest (F(2,104)=4.54, p=0.01, ηp2=0.08). These findings demonstrate no effects of sweet taste exposure at breakfast for 1 or 3 weeks on pleasantness, desire for, sweetness or intakes of other sweet foods in either the same (breakfast) or in a different (lunch) meal context.

PMID:34167596 | DOI:10.1017/S000711452100235X

Pilot Feasibility Stud. 2021 Jun 24;7(1):133. doi: 10.1186/s40814-021-00869-1.

ABSTRACT

BACKGROUND: Hand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life. Incidence is higher amongst women, particularly around the age of the menopause. Whilst the relationship between sex hormones and OA has been studied in vitro, in epidemiological studies and in clinical trials of hormone replacement therapy (HRT), this study is the first to investigate the effect of estrogen-containing therapy on hand pain in post-menopausal women with symptomatic hand OA in a randomised study design.

METHODS: This is a feasibility study of a double-blinded placebo-controlled intervention with 1:1 randomisation to either a combination of conjugated estrogens 0.45 mg and bazedoxifene acetate 20 mg (Duavive) or placebo. The target population is post-menopausal women with symptomatic hand OA, aiming to recruit 60-90 study participants. The primary objective is to assess the feasibility of a future fully powered randomised controlled trial (RCT). Participants will take the study medication for 24 weeks and be followed up for 28 weeks after randomisation. The primary outcomes used to determine feasibility are eligible participant identification rates and routes; recruitment, randomisation and retention rates of eligible participants; study medication compliance; and the likelihood of unintentional unblinding. Secondary outcomes include measures of hand pain, function, appearance and menopausal symptoms. An end of study questionnaire and focus groups will help to refine the final protocol for a full study.

DISCUSSION: Identifying new treatments for symptomatic hand OA is a recognised research priority. The study will help us to understand whether there are sufficient interested and eligible individuals in this target population who would consider HRT for their hand symptoms. It will provide proof-of-concept RCT data on the effects of HRT on hand pain and other clinically relevant outcomes in this population. The study will gain valuable information on the feasibility of a full RCT and how best to run this. The findings will be published in a peer-reviewed journal and presented at a relevant conference.

TRIAL REGISTRATION: ISRCTN12196200 registered on 15 January 2019.

PMID:34167594 | DOI:10.1186/s40814-021-00869-1

Eur J Med Res. 2021 Jun 24;26(1):59. doi: 10.1186/s40001-021-00531-9.

ABSTRACT

BACKGROUND: Femoral neck shortening can occur in young patients receiving internal fixation for Pauwels type II femoral neck fracture. The risk factors for neck shortening, which can affect hip function, are not clear. This study aimed to retrospectively identify risk factors for neck shortening after internal fixation with parallel partially threaded cannulated cancellous screws (FPTCS) for Pauwels type II femoral neck fracture in relatively young patients.

METHODS: Clinical data from 122 cases with Pauwels type II femoral neck fracture from February 2014 to February 2019 were reviewed and analyzed, and causes of neck shortening were statistically analyzed. And the Chi-squared test or Fisher’s exact test was used to compare indicators. Multivariate analysis was conducted with non-conditional logistic regression analysis.

RESULTS: Statistically significant differences were found in age, sex, BMD, BMI, fracture type, posterior medial cortex comminution, and reduction quality between patients with femoral neck shortening and those without femoral neck shortening. Logistic regression analysis showed that fracture type, posterior medial cortex comminution, and reduction quality were the main risk factors for neck shortening.

CONCLUSION: Fracture type, posterior medial cortex comminution, and reduction quality can be used as important reference indexes to predict the possibility of neck shortening after internal fixation with FPTCS for Pauwels type II femoral neck fracture in young patients. BMD and BMI may be also risk factors.

PMID:34167592 | DOI:10.1186/s40001-021-00531-9