Tag: statistics

Arch Esp Urol. 2023 Mar;76(2):161-168. doi: 10.56434/j.arch.esp.urol.20237602.18.

ABSTRACT

OBJECTIVE: To assess the clinical outcome of 1470 nm diode laser enucleation of the prostate (DiLEP) vs. bipolar transurethral enucleation of prostate (TUEP) for benign prostatic hyperplasia (BPH).

METHODS: One hundred and fifty-seven patients were retrospectively involved in this study. Eighty-two patients underwent DiLEP while 75 underwent bipolar TUEP. Seventy-three patients in DiLEP and sixty-nine in bipolar TUEP completed the 3-year follow-up, respectively. The baseline properties, perioperative data, and postsurgical outcomes were evaluated.

RESULTS: No statistically significant differences were found between DiLEP and bipolar TUEP in preoperative parameters. Significantly shorter operating time was noted in DiLEP group (p = 0.000). No patient suffered dangerous complications, and none in either group required a blood transfusion. No statistically significant differences were found between DiLEP and bipolar TUEP in the decrease in hemoglobin or sodium. During the 3-year postoperative follow-up, ongoing and significant improvements were found in both groups without any difference.

CONCLUSIONS: Both DiLEP and bipolar TUEP can improve low urinary tract symptoms (LUTS) secondary to BPH in a comparable way with high efficacy. Compared with bipolar TUEP, DiLEP with a morcellator required a shorter operative time.

PMID:37139622 | DOI:10.56434/j.arch.esp.urol.20237602.18

Arch Esp Urol. 2023 Mar;76(2):132-138. doi: 10.56434/j.arch.esp.urol.20237602.14.

ABSTRACT

AIM: To compare serum endothelial-specific molecule-1 (ESM-1 or endocan) levels between individuals with primary bladder cancer (BC) who have various pathological features of BC and healthy volunteers.

MATERIALS AND METHODS: 154 consecutive patients with primary BC (Group-1) and 52 healthy volunteers (Group-2) were accepted into this prospective, non-randomized, observational research between January 2017 and December 2018. Peripheral blood samples were obtained from each participant to measure serum ESM-1/endocan levels. Group-1 was further divided into subgroups as Group-1A (pTa), Group-1B (pT1) and Group-1C (pT2) based on the transurethral resection of bladder tumour (TURBT) histopathological results. In addition Group-1 was divided into other subgroups based on pathological features of BC including tumor grade, tumor volume and muscle-invasive status. Groups were compared statistically regarding ESM-1/endocan levels.

RESULTS: Median age of the individuals was 63 (22) years in Group-1 and 66 (11) years in Group-2 (p = 0.051). There were 140 (90.9%) males and 14 (9.1%) females in Group-1 and 30 (57.7%) males and 22 (42.3%) females in Group-2 (p < 0.001). The serum ESM-1/endocan measurements were lower in Group-2 than in Group-1 (p = 0.018). Of the patients in Group-1, 62 (40.3%) had low-grade tumors and 92 (59.7%) had high-grade tumors. When Group-1 was further divided into other subgroups according to different pathological features of BC such as tumor stage, grade, muscle-invasive status and tumor volume it was detected that there was a statistically meaningful difference between all subgroups of Group-1 and Group-2 in terms of serum ESM-1/endocan levels (p < 0.05 for each). The serum ESM-1/endocan cut-off value (3.472 ng/mL) had a specificity of 57.7%, sensitivity of 59.1%, NPV (negative predictive value) of 32.3% and PPV (positive predictive value) of 80.5% for predicting the presence of BC with an AUC (Area Under the Curve) of 0.609 (95% confidence interval (CI) 0.524-0.694; p = 0.018).

CONCLUSIONS: The serum ESM-1/endocan levels can be considered a potentially useful predictor for BC. Higher serum ESM-1/endocan levels are related with poor pathological outcomes in BC.

PMID:37139618 | DOI:10.56434/j.arch.esp.urol.20237602.14

J Med Ethics. 2023 May 3:jme-2023-108916. doi: 10.1136/jme-2023-108916. Online ahead of print.

ABSTRACT

Despite the frequent invocation of ‘false hope’ and possible related moral concerns in the context of assisted reproduction technologies, a focused ethical and conceptual problematisation of this concept seems to be lacking. We argue that an invocation of ‘false hope’ only makes sense if the fulfilment of a desired outcome (eg, a successful fertility treatment) is impossible, and if it is attributed from an external perspective. The evaluation incurred by this third party may foreclose a given perspective from being an object of hope. However, this evaluation is not a mere statistical calculation or observation based on probabilities but is dependent on several factors that should be acknowledgeable as morally relevant. This is important because it allows room for, and encourages, reasoned disagreement and moral negotiation. Accordingly, the object of hope itself, whether or not based on socially embedded desires or practices, can be a topic of debate.

PMID:37137697 | DOI:10.1136/jme-2023-108916

Inj Prev. 2023 May 3:ip-2023-044855. doi: 10.1136/ip-2023-044855. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess implementation fidelity of the Stay One Step Ahead (SOSA), a complex intervention which was delivered by health visiting teams, children’s centres, and family mentors and was aimed at preventing unintentional home injuries in children under 5 in disadvantaged communities.

STUDY DESIGN: A mixed-methods evaluation of the implementation fidelity of the SOSA intervention.

METHODS: A conceptual framework for implementation fidelity was used to triangulate data from questionnaires and semistructured interviews with parents and practitioners, observations of parent and practitioner contacts, and meeting documents. Quantitative data were analysed using logistic regression and descriptive statistics. Thematic analysis was used for qualitative data.

RESULTS: Parents in intervention wards were more likely to receive home safety advice from a practitioner than those living in matched control wards. Monthly safety messages and family mentor home safety activities were delivered with greater fidelity than other intervention components. Content most frequently adapted included the home safety checklist used by health visiting teams, and safety weeks delivered at children’s centres.

CONCLUSION: Consistent with similarly complex interventions, SOSA was delivered with variable fidelity in a challenging environment. The findings add to the body of evidence on implementation fidelity of home injury prevention programmes, providing important information for future intervention development and delivery.

PMID:37137688 | DOI:10.1136/ip-2023-044855

Eur J Hosp Pharm. 2023 May 3:ejhpharm-2023-003738. doi: 10.1136/ejhpharm-2023-003738. Online ahead of print.

ABSTRACT

OBJECTIVE: 24-hour urine creatinine clearance (ClCr 24 hours) remains the gold standard for estimating glomerular filtration rate (GFR) in critically ill patients; however, simpler methods are commonly used in clinical practice. Serum creatinine (SCr) is the most frequently used biomarker to estimate GFR; and cystatin C, another biomarker, has been shown to reflect GFR changes earlier than SCr. We assess the performance of equations based on SCr, cystatin C and their combination (SCr-Cyst C) for estimating GFR in critically ill patients.

METHODS: Observational unicentric study in a tertiary care hospital. Patients with cystatin C, SCr and ClCr 24 hours measurements in ±2 days admitted to an intensive care unit were included. ClCr 24 hours was considered the reference method. GFR was estimated using SCr-based equations: Chronic Kidney Disease Epidemiology Collaboration based on creatinine (CKD-EPI-Cr) and Cockcroft-Gault (CG); cystatin C-based equations: CKD-EPI-CystC and CAPA; and Cr-CystC-based equations: CKD-EPI-Cr-CystC. Performance of each equation was assessed by calculating bias and precision, and Bland-Altman plots were built. Further analysis was performed with stratified data into CrCl 24 hours <60, 60-130 and ≥130 mL/min/1.73 m².

RESULTS: We included 275 measurements, corresponding to 186 patients. In the overall population, the CKD-EPI-Cr equation showed the lowest bias (2.6) and best precision (33.1). In patients with CrCl 24 hours <60 mL/min/1.73 m², cystatin-C-based equations showed the lowest bias (<3.0) and CKD-EPI-Cr-CystC was the most accurate (13.6). In the subgroup of 60≤ CrCl 24 hours <130mL/min/1.73 m², CKD-EPI-Cr-CystC was the most precise (20.9). However, in patients with CrCl 24 hours ≥130mL/min/1.73 m², cystatin C-based equations underestimated GFR, while CG overestimated it (22.7).

CONCLUSIONS: Our study showed no evidence of superiority of any equation over the others for all evaluated parameters: bias, precision and Lin’s concordance correlation coefficient. Cystatin C-based equations were less biased in individuals with impaired renal function (GFR <60 mL/min/1.73 m²). CKD-EPI-Cr-CystC performed properly in patients with GFR from 60-130 mL/min/1.73 m² and none of them were accurate enough in patients ≥130 mL/min/1.73 m².

PMID:37137686 | DOI:10.1136/ejhpharm-2023-003738

Open Heart. 2023 May;10(1):e002224. doi: 10.1136/openhrt-2022-002224.

ABSTRACT

BACKGROUND: Structural changes caused by spinal curvature may impact the organs within the thoracic cage, including the heart. Cardiac abnormalities in patients with idiopathic scoliosis are often studied post-corrective surgery or secondary to diseases. To investigate cardiac structure, function and outcomes in participants with scoliosis, phenotype and imaging data of the UK Biobank (UKB) adult population cohort were analysed.

METHODS: Hospital episode statistics of 502 324 adults were analysed to identify participants with scoliosis. Summary 2D cardiac phenotypes from 39 559 cardiac MRI (CMR) scans were analysed alongside a 3D surface-to-surface (S2S) analysis.

RESULTS: A total of 4095 (0.8%, 1 in 120) UKB participants were identified to have all-cause scoliosis. These participants had an increased lifetime risk of major adverse cardiovascular events (MACEs) (HR=1.45, p<0.001), driven by heart failure (HR=1.58, p<0.001) and atrial fibrillation (HR=1.54, p<0.001). Increased radial and decreased longitudinal peak diastolic strain rates were identified in participants with scoliosis (+0.29, P_adj <0.05; -0.25, P_adj <0.05; respectively). Cardiac compression of the top and bottom of the heart and decompression of the sides was observed through S2S analysis. Additionally, associations between scoliosis and older age, female sex, heart failure, valve disease, hypercholesterolemia, hypertension and decreased enrolment for CMR were identified.

CONCLUSION: The spinal curvature observed in participants with scoliosis alters the movement of the heart. The association with increased MACE may have clinical implications for whether to undertake surgical correction. This work identifies, in an adult population, evidence for altered cardiac function and an increased lifetime risk of MACE in participants with scoliosis.

PMID:37137668 | DOI:10.1136/openhrt-2022-002224

BMJ Open. 2023 May 3;13(5):e070345. doi: 10.1136/bmjopen-2022-070345.

ABSTRACT

INTRODUCTION: Renin-angiotensin system (RAS) plays a key role in various types of cardiovascular disease and many kinds of RAS inhibitors have been developed. The effect of discontinuation of RAS inhibitors on clinical outcomes is still controversial. This study aims to evaluate the effects of discontinuing RAS inhibitor medication on the clinical outcomes of patients continuously taking these agents.

METHODS AND ANALYSIS: This article presents a systematic review protocol described in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will include randomised controlled trials in which the effects of RAS inhibitor withdrawal were evaluated. Initially, four authors will search for eligible studies in MEDLINE, EMBASE, the Cochrane Database Trial Register, European trial registry and ClinicalTrials.gov. Abstracts and full-text screenings will be performed by the four authors with data extraction performed by each author independently. We will include patients taking RAS inhibitors-including ACE inhibitor, angiotensin receptor blocker and angiotensin receptor neprilysin inhibitor and exclude the patients undergoing renal replacement therapy (RRT), adolescents (under 18 years of age) and patients with acute infectious diseases. Our search will be performed on 1 May 2023. Studies in which the patients discontinued RAS inhibitors due to any reason will be included. Patients who continuously took RAS inhibitors under conditions in which the intervention group discontinued these agents will be considered eligible as the comparison group. Death (any cause), Death (cardiovascular disease (CVD)) and CVD events will be set as primary outcomes. Secondary outcomes will be set as RRT, acute kidney injury, renal function (analysis of the change in estimated glomerular filtration rate), hyperkalaemia, proteinuria and blood pressure.

ETHICS AND DISSEMINATION: Research ethics approval was not required in this study due to it being a systematic review, and any data belonging to individuals cannot be identified. The results of this study will be disseminated through peer-reviewed journals and conferences.

TRIAL REGISTRATION NUMBER: PROSPERO CRD42022300777.

PMID:37137558 | DOI:10.1136/bmjopen-2022-070345

BMJ Open. 2023 May 3;13(5):e068499. doi: 10.1136/bmjopen-2022-068499.

ABSTRACT

INTRODUCTION: Negative pressure wound therapy (NPWT) in acute burn care may decrease the time to re-epithelialisation by more than 20%. Despite this, the perceived burden of use; including therapeutic, physical and financial, have limited the use of NPWT in acute burn care. This might be minimised by using the small, ultraportable, single-use NPWT device PICO as opposed to larger devices, which to date has never been studied in acute burn care. This research will; therefore, primarily assess the feasibility, acceptability and safety of PICO in paediatric burns. Secondary outcomes include time to re-epithelialisation, pain, itch, cost and scar formation.

METHODS AND ANALYSIS: This protocol details a clinical trial methodology and is pre-results. This single site, prospective, pilot randomised controlled trial will be conducted in an Australian quaternary paediatric burns centre. Participants must be aged ≤16 years, otherwise well and managed within 24 hours of sustaining a burn that fits beneath a PICO dressing. Thirty participants will be randomised to one of three groups: group A: Mepitel and ACTICOAT, group B: Mepitel, ACTICOAT and PICO and group C: Mepitel, ACTICOAT Flex and PICO. Patient outcomes will be recorded at each dressing change to assess efficacy and safety outcomes until 3 months postburn wound re-epithelialisation. Surveys, randomisation and data storage will be undertaken via online platforms and physical data storage collated at the Centre for Children’s Health Research, Brisbane, Australia. Analysis will be done by using StataSE 17.0 statistical software.

ETHICS AND DISSEMINATION: Ethics has been obtained from Queensland Health and Griffith Human Research Ethics committees including a site-specific approval. These data will be disseminated via clinical meetings, conference presentations and peer-reviewed journals.

TRIAL REGISTRATION NUMBER: ACTRN12622000009718.

PMID:37137557 | DOI:10.1136/bmjopen-2022-068499

Int J Rheum Dis. 2023 May 3. doi: 10.1111/1756-185X.14710. Online ahead of print.

ABSTRACT

INTRODUCTION: Restless leg syndrome (RLS) is a neurological disorder characterized by an uncontrollable desire to move legs along with abnormal sensations, particularly at night, which can lead to sleep disturbance. RLS may mimic rheumatic diseases or can be associated with them, hence their identification and treatment are important to improve sleep quality and overall quality of life in rheumatic diseases.

METHODS: We conducted a search of the PubMed, SCOPUS, and EMBASE databases to identify studies reporting a prevalence of RLS in patients with rheumatic disease. Two authors independently screened, selected, and extracted the data. Heterogeneity was assessed using I² statistics and random effect method of the meta-analysis was used to synthesize the results.

RESULTS: Out of 273 unique records, 17 eligible studies including 2406 rheumatic patients were identified. RLS prevalence (95% CI) among patients of rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, fibromyalgia and ankylosing spondylitis are found to be 26.6% (18.6 34.6); 32.5% (23.1-41.9), 4.4% (2.0-6.8), 38.1% (31.3-45.0) and 30.8% (23.48-39.16) respectively. RLS prevalence was similar for males and females.

CONCLUSION: Our study indicates a high prevalence of RLS in patients with rheumatic diseases. Early detection and treatment of RLS in patients with rheumatic conditions could be beneficial in improving their overall health and quality of life.

PMID:37137528 | DOI:10.1111/1756-185X.14710

Stroke Vasc Neurol. 2023 May 3:svn-2022-002276. doi: 10.1136/svn-2022-002276. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: The ring finger protein 213 gene (RNF213) p.R4810K variant increased the risk of acute ischaemic stroke (AIS) attributable to intracranial arterial stenosis (ICAS) in the Japanese and Korean populations. In this study, we aimed to examine the prevalence of the RNF213 p.R4810K variant in Chinese patients with AIS or transient ischaemic attack and identify the phenotype of the carriers.

METHODS: We analysed data from the Third China National Stroke Registry. All included participants were divided into two groups by carrier status of the p.R4810K variant. The aetiological classification was conducted according to the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. The presence of ICAS and extracranial arterial stenosis (ECAS) was defined as 50%-99% stenosis or occlusion of any intracranial and extracranial artery. Logistic regression models and Cox regression models were used to evaluate the association of the p.R4810K variant with TOAST classification, stenosis phenotypes and clinical outcomes.

RESULTS: A total of 10 381 patients were enrolled, among which 56 (0.5%) had the heterozygote GA genotype for p.R4810K. The variant carriers were younger (p=0.01), and more likely to suffer from peripheral vascular disease (p=0.04). The p.R4810K variant was associated with large-artery atherosclerosis (LAA) (adjusted OR=1.94, 95% CI 1.13 to 3.33), anterior circulation stenosis (adjusted OR=2.12, 95% CI 1.23 to 3.65) and ECAS (adjusted OR=2.29, 95% CI 1.16 to 4.51). Nevertheless, the p.R4810K variant was not associated with recurrence, poor functional outcome and mortality at 3 months and 1 year.

CONCLUSIONS: The RNF213 p.R4810K variant was associated with LAA, anterior circulation stenosis and ECAS in Chinese patients. Given the low carrying rate and only 1-year follow-up information, caution should be taken to interpret our findings in no statistically significant association between the p.R4810K variant and stroke prognosis in Chinese patients.

PMID:37137523 | DOI:10.1136/svn-2022-002276