Tag: pubmed

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

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

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

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

J Otolaryngol Head Neck Surg. 2021 Jun 24;50(1):39. doi: 10.1186/s40463-021-00520-2.

ABSTRACT

OBJECTIVES: This study was performed to evaluate the efficacy of microwave ablation (MWA) eustachian tuboplasty for the treatment of patients with retracted tympanic membrane (TM) due to eustachian tube dysfunction (ETD).

METHODS: This was a prospective study of 20 patients with ETD (middle ear atelectasis) who underwent MWA eustachian tuboplasty. Outcomes included the ability to perform a Valsalva maneuver, audiometry results, tympanometry results, ETD Questionnaire (ETDQ-7) score, and TM status.

RESULTS: Eighteen patients (18 ears) were included in this study. There were statistically and clinically significant improvements in the mean ETDQ-7 score at 6 months postoperatively (change in mean score of 16.7 ± 3.6, P < 0.001) and at 30 months postoperatively (change in mean score of 18.9 ± 2.9, P < 0.001). Type A tympanogram was obtained in 27.8% of patients (5/18) at 6 months postoperatively, and in 77.7% at 30 months postoperatively. A Valsalva maneuver was possible in 72.2% of patients at 6 months postoperatively and in 88.9% of patients at 30 months postoperatively. In addition, the ears of 13 patients (72.2%) showed both normal tympanograms and TM at 30 months postoperatively. Interestingly, 38.5% of patients (5/13) exhibited complete sclerosis of the pars tensa. None of the patients experienced severe MWA-related complications during follow-up.

CONCLUSIONS: MWA eustachian tuboplasty is a feasible alternative to conventional tuboplasty, and can improve subjective and objective outcomes in patients with ETD for up to 30 months following treatment. In addition, this study showed that the extent of sclerotic plaque increased over time, whereas the extents of atrophy and tensa retraction decreased following tuboplasty in most patients.

PMID:34167591 | DOI:10.1186/s40463-021-00520-2

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

Ann Coloproctol. 2021 Jun 24. doi: 10.3393/ac.2020.01004.0143. Online ahead of print.

ABSTRACT

PURPOSE: The emergency intervention for acute malignant left-sided colonic obstruction remains controversial. Conflicting reports exist regarding the efficacy and safety of endoscopic placement of self-expandable metallic stents (SEMS) vs. primary surgery. Most reports focus on SEMS insertion as a bridge to surgery.

METHODS: An observational nonrandomized study at a single center in Cairo, Egypt included 65 high-risk patients (American Society of Anesthesiologists physical status classification ≥ III, age > 60 years) with acute malignant metastatic (stage IV) colonic obstruction. Twenty-nine patients underwent primary surgery (Hartmann’s procedure, HP), and 35 patients underwent SEMS insertion.

RESULTS: All cases that underwent SEMS insertion were technically successful. The 2 procedures were comparable in clinical success rates but a statistically significant difference existed between them regarding the duration of postoperative hospital stay in the HP and SEMS group (7.7 ± 3.1 days vs. 3.5 ± 0.6 days, retrospectively; P < 0.001), the interval before regaining oral feeding (41.8 ± 26.8 hours vs. 27.6 ± 18.5 hours, retrospectively; P = 0.015), and the duration of intensive care unit (ICU) admission (5.0 ± 1.7 days vs. 1.5 ± 0.7 days, retrospectively; P = 0.035). Six patients (20.7%) in the HP group and 2 patients (5.7%) in the SEMS group required postoperative ICU admission.

CONCLUSION: SEMS placement provides comparable efficacy and safety to HP in managing acute malignant obstruction of the rectosigmoid region in high-risk individuals, with faster recovery and less hospital and ICU admission time.

PMID:34167187 | DOI:10.3393/ac.2020.01004.0143

J Pediatr Endocrinol Metab. 2021 Jun 24. doi: 10.1515/jpem-2021-0160. Online ahead of print.

ABSTRACT

OBJECTIVES: Premature adrenarche may be associated with an intrauterine programmed metabolic syndrome which should be considered as a warning sign for coronary heart disease due to accelerated atherosclerosis, hypertension, type 2 diabetes mellitus (DM), and polycystic ovary syndrome.

METHODS: Seventy-three patients with premature adrenarche were evaluated for metabolic parameters and aortic elasticity to evaluate the susceptibility to atherosclerosis and compared with a control group. The patients were examined in two groups as overweight and nonoverweight, and metabolic and cardiac parameters were also compared among these groups. Strain, distensibility, and stiffness index parameters were used to evaluate aortic elasticity.

RESULTS: Biochemical parameters and cardiac measurements were not statistically different between patients and controls. They also did not differ between patients with normal weight and overweight groups. Atherogenic index and insulin resistance were closely related and a positive correlation between cholesterol and triglyceride, and ascending aortic stiffness was found.

CONCLUSIONS: The results may suggest that cholesterol and triglyceride-related arterial involvement is more involved in the pathogenesis of arterial stiffness. It can be considered that ‘being overweight’ or ‘having metabolic profile characterized by insulin resistance and dyslipidemia’ are the major coexisting factors influencing the vascular structure, rather than increased androgens and premature adrenarche itself.

PMID:34167179 | DOI:10.1515/jpem-2021-0160

Radiol Oncol. 2021 Jun 25. doi: 10.2478/raon-2021-0030. Online ahead of print.

ABSTRACT

BACKGROUND: Guidelines have reported that although microwave ablation (MWA) has potential advantages over radiofrequency ablation (RFA), superiority in efficacy and safety remain unclear. Aim of the study is to compare MWA with RFA in the treatment of liver cancer.

METHODS: Meta-analysis was conducted according to the PRISMA guidelines for studies published from 2010 onwards. A random-effects model was used for the meta-analyses. Complete ablation (CA), local tumor progression (LTP), intrahepatic distant recurrence (IDR), and complications were analyzed.

RESULTS: Four randomized trials and 11 observational studies with a total of 2,169 patients met the inclusion criteria. Although overall analysis showed no significant difference in LTP between MWA and RFA, subgroup analysis including randomized trials for patients with hepatocellular cancer (HCC) demonstrated statistically decreased rates of LTP in favor of MWA (OR, 0.40; 95% CI, 0.18-0.92; p = 0.03). No significant differences were found between the two procedures in CA, IDR, complications, and tumor diameter less or larger than 3 cm.

CONCLUSIONS: MWA showed promising results and demonstrated better oncological outcomes in terms of LTP compared to RFA in patients with HCC. MWA can be utilized as the ablation method of choice in patients with HCC.

PMID:34167181 | DOI:10.2478/raon-2021-0030

J Obstet Gynaecol Res. 2021 Jun 24. doi: 10.1111/jog.14901. Online ahead of print.

ABSTRACT

OBJECTIVE: To develop a screening tool for the risk factors potentially indicating methamphetamine use in pregnant women who are not receiving prenatal care.

METHOD: This prospective cohort, Institutional Review Board-approved study was performed at a university hospital in Thailand between January 2017 and January 2019. A screening tool was developed using data from 125 pregnant women not receiving prenatal care upon their first admission for childbearing at the hospital delivery room. Potential factors obtained from the patient’s history, physical examination, and methamphetamine use in pregnancy or had a urine amphetamine test positive were entered into a logistic regression analysis. The discriminative ability of the screening tool was expressed by the area under the receiver operating characteristic curve (AUROC) sensitivity and specificity, while bootstrapping was used for internal validation.

RESULTS: The screening covered four factors: smoking (odds ratio 7.73, score = 2), drinking (3.81, score = 1), living with a spouse or friend who uses methamphetamine (17.28, score = 3), BP ≥ 130/90 mmHg (2.47, score = 1). The AUROC for the model was 0.87, 95% CI, 0.81-0.93 (SE: 0.03). A total points score ≥3 represented the best cut-off value, with a sensitivity of 81% and specificity of 82%. Across the bootstrapping, the C-statistic for the full screening was 0.86, 95% CI, 0.81-0.93 (SE: 0.03).

CONCLUSION: A screening tool was developed with an excellent ability to discriminate the risk factors potentially indicating methamphetamine use in pregnant women not receiving prenatal care. Validation in pregnant women receiving prenatal care still needs to be performed.

PMID:34167171 | DOI:10.1111/jog.14901