Tag: statistics

BJPsych Open. 2023 May 26;9(3):e96. doi: 10.1192/bjo.2023.57.

ABSTRACT

BACKGROUND: Brain in Hand (BIH) is a UK-based digital self-support system for managing anxiety and social functioning.

AIMS: To identify the impact of BIH on the psychological and social functioning of adults with autism.

METHOD: Adults with diagnosed or suspected DSM-5 (level 1) autism, identified by seven NHS autism services in England and Wales, were recruited for a 12-week prospective mixed-methods cohort study. The primary quantitative outcome measures were the Health of the Nation Outcome Scales for People with Learning Disabilities (HONOS-LD) and the Hospital Anxiety and Depression Scale (HADS). Fisher’s exact test explored sociodemographic associations. Paired t-test was utilised for pre-post analysis of overall effectiveness of BIH. Multivariable linear regression models, univariable pre-post analysis, Wilcoxon signed-rank test, logistic regression analysis, Bonferroni correction and normative analysis were used to give confidence in changes identified. A thematic analysis of semi-structured exist interviews following Braun and Clarke’s six-step process of 10% of participants who completed the study was undertaken.

RESULTS: Sixty-six of 99 participants completed the study. There was significant reduction in mean HONOS-LD scores, with 0.65 s.d. decrease in those who used BIH for 12 weeks. Significant positive changes were identified in HONOS-LD subdomains of ‘self-injurious behaviours’, ‘memory and orientation’, ‘communication problems in understanding’, ‘occupation and activities’ and ‘problems with relationship’. A significant reduction in the anxiety, but not depression, component of the HADS scores was identified. Thematic analysis showed high confidence in BIH.

CONCLUSIONS: BIH improved anxiety and other clinical, social and functioning outcomes of adults with autism.

PMID:37232106 | DOI:10.1192/bjo.2023.57

Hosp Pediatr. 2023 May 26:e2022006917. doi: 10.1542/hpeds.2022-006917. Online ahead of print.

ABSTRACT

OBJECTIVES: To assess the performance of pediatric residents in recognizing a decompensating patient with impending respiratory failure and appropriately escalating care using a virtual reality (VR) simulated case of an infant with bronchiolitis after an extended period of decreased clinical volumes during the coronavirus disease 2019 (COVID-19) pandemic.

METHODS: Sixty-two pediatric residents at a single academic pediatric referral center engaged in a 30-minute VR simulation on respiratory failure in a 3-month-old admitted to the pediatric hospital medicine service with bronchiolitis. This occurred in a socially distant manner across the Zoom platform during the COVID-19 pandemic (January-April 2021). Residents were assessed on their ability to (1) recognize altered mental status (AMS), (2) designate clinical status as “(impending) respiratory failure,” and (3) escalate care. Statistical differences between and across postgraduate year (PGY) levels were examined using χ2 or Fisher’s exact test, followed by pairwise comparison and posthoc multiple testing using the Hochberg test.

RESULTS: Among all residents, 53% successfully recognized AMS, 16% identified respiratory failure, and 23% escalated care. No significant differences were seen across PGY levels for recognizing AMS or identifying respiratory failure. PGY3+ residents were more likely to escalate care than PGY2 residents (P = .05).

CONCLUSIONS: In the setting of an extended period with decreased clinical volumes during the COVID-19 pandemic, pediatric residents across all PGY levels demonstrated challenges with identifying (impending) respiratory failure and appropriately escalating care during VR simulations. Though limited, VR simulation may serve as a safe adjunct for clinical training and assessment during times of decreased clinical exposure.

PMID:37232100 | DOI:10.1542/hpeds.2022-006917

Cancer Res Treat. 2023 May 25. doi: 10.4143/crt.2023.333. Online ahead of print.

ABSTRACT

PURPOSE: This study evaluated whether combination therapy is more effective than monotherapy in elderly patients with metastatic or recurrent gastric cancer (MRGC) as first-line chemotherapy.

MATERIALS AND METHODS: Elderly (≥70 years) chemo-naïve patients with MRGC were allocated to receive either combination therapy (group A: 5-FU/oxaliplatin, capecitabine/oxaliplatin, capecitabine/cisplatin, or S-1/cisplatin) or monotherapy (group B; 5-FU, capecitabine, or S-1). In group A, starting doses were 80% of standard doses, and they could be escalated to 100% at the discretion of the investigator. Primary endpoint was to confirm superior overall survival (OS) of combination therapy vs monotherapy.

RESULTS: After 111 of the planned 238 patients were randomized, enrollment was terminated due to poor accrual. In the full-analysis population [group A (n=53) and group B (n=51)], median OS of combination therapy vs. monotherapy was 11.5 vs. 7.5 months [hazard ratio (HR), 0.86; 95% confidence interval (CI), 0.56-1.30; p=0.231]. Median progression-free survival (PFS) was 5.6 vs. 3.7 months (HR, 0.53; 95% CI, 0.34-0.83; p=0.005). In subgroup analyses, patients aged 70-74 years tended to have superior OS with combination therapy [15.9 vs. 7.2 months (p=0.056)]. Treatment-related adverse events (TRAEs) occurred more frequently in group A vs. group B. However, among severe TRAEs (≥grade 3), there were no TRAEs with a frequency difference of > 5%.

CONCLUSION: Combination therapy was associated with numerically improved OS, although statistically insignificant, and a significant PFS benefit compared with monotherapy. Although combination therapy showed more frequent TRAEs, there was no difference in the frequency of severe TRAEs.

PMID:37232070 | DOI:10.4143/crt.2023.333

J Cerebrovasc Endovasc Neurosurg. 2023 May 26. doi: 10.7461/jcen.2023.E2022.11.005. Online ahead of print.

ABSTRACT

OBJECTIVE: Cerebral collateral circulation may affect subarachnoid hemorrhage (SAH) induced cerebral vasospasm and delayed cerebral ischemia. In this study our aim was to investigate the relationship between collateral status, vasospasm and delayed cerebral ischemia (DCI) in both aneurysmal and nonaneurysmal SAH.

METHODS: Patients diagnosed as SAH with and without aneurysm were included and their data investigated retrospectively. After the patients diagnosed as SAH according to cerebral computed tomography (CT)/magnetic resonance imaging (MRI), they underwent cerebral angiography to check for cerebral aneurysm. The diagnosis of DCI was made according to the neurological examination and control CT/MRI. All the patients had their control cerebral angiography on days 7 to 10 in order to assess vasospasm and also collateral circulation. The American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) Collateral Flow Grading System was modified to measure collateral circulation.

RESULTS: A total of 59 patients data were analyzed. Patients with aneurysmal SAH had higher Fisher scores and DCI was more common. Although there was no statistically significant difference between the patients with and without DCI in terms of demographics and mortality, patients with DCI had worse collateral circulation and more severe vasospasm. These patients had higher Fisher scores and more cerebral aneurysm overall.

CONCLUSIONS: According to our data, patients with higher Fisher scores, more severe vasospasm, and poor cerebral collateral circulation may experience DCI more frequently. Additionally aneurysmal SAH had higher Fisher scores and DCI was seen more common. To improve the clinical results for SAH patients, we believe that physicians should be aware of the DCI risk factors.

PMID:37232069 | DOI:10.7461/jcen.2023.E2022.11.005

Low Urin Tract Symptoms. 2023 May 26. doi: 10.1111/luts.12483. Online ahead of print.

ABSTRACT

OBJECTIVES: Convective water vapor thermal therapy (CWVTT-Rezum) is a minimally invasive surgical therapy that is being increasingly utilized for bladder outlet obstruction. Most patients leave the site of care with a Foley catheter in place for a mean reported duration of 3-4 days. A minority of men will fail their trial without catheter (TWOC). We aim to identify the frequency of TWOC failure following CWVTT and its associated risk factors.

METHODS: Patients who underwent CWVTT at a single institution from October 2018 to May 2021 were retrospectively identified and pertinent data extracted. The primary endpoint was TWOC failure. Descriptive statistics were performed, and rate of TWOC failure was determined. Potential risk factors for failed TWOC were assessed through univariate and multivariate logistic regression.

RESULTS: A total of 119 patients were analyzed. Seventeen percent (20/119) had a failed TWOC on their first attempt. Of those, 60% (12/20) failed in a delayed fashion. In patients who failed, the median number of total TWOC attempts required for success was two (interquartile range [IQR] = 2-3). All patients eventually had a successful TWOC. The median preoperative postvoid residual for successful and failed TWOC was 56 mL (IQR = 15-125) and 87 mL (IQR = 25-367), respectively. Preoperative elevated postvoid residual (unadjusted odds ratio [OR] 1.02, 95% CI: 1.01-1.04; adjusted OR 1.02, 95% CI: 1.01-1.04) was associated with TWOC failure.

CONCLUSIONS: Seventeen percent of patients failed their initial TWOC after CWVTT. Elevated postvoid residual was associated with TWOC failure.

PMID:37232068 | DOI:10.1111/luts.12483

Orthop Surg. 2023 May 25. doi: 10.1111/os.13757. Online ahead of print.

ABSTRACT

OBJECTIVE: The effectiveness of arthroscopic rotator cuff repair (ARCR) on rheumatoid arthritis (RA) patients remains a controversial topic. This study investigates the mid-term outcomes of ARCR in RA patients and identifies the factors influencing clinical efficacy.

METHODS: This retrospective study enrolled RA patients with small or medium rotator cuff tears (RCTs) between February 2014 and February 2019. Visual Analog Scale (VAS), American Shoulder and Elbow Surgeons (ASES), and Constant-Murley scores were collected at each follow-up time. Ultimately, magnetic resonance imaging (MRI) and X-ray were employed to assess rotator cuff integrity and progression of shoulder bone destruction, respectively. Statistical methods used two-way repeated-measures ANOVA or generalized estimation equations.

RESULTS: A total of 157 patients were identified and divided into ARCR (n = 75) and conservative treatment (n = 82) groups. ARCR group continued to be divided into small tear (n = 35) and medium tear (n = 40) groups. At the final, all scores were better in ARCR group than in the conservative treatment group (p < 0.05). A radiographic evaluation of the final follow-up demonstrated that the progression rate in ARCR group (18.67%) was significantly lower than that of the conservative treatment group (39.02%, p < 0.05). In the comparison of the small tear and medium tear groups, all scores increased significantly after surgery (p < 0.05), and the final follow-up scores were better than preoperative scores (p < 0.05) but worse than those of the 6-month postoperative follow-up (p < 0.05). Comparison between the two groups revealed that all scores of the small tear group were significantly better than those of the medium tear group at 6-month postoperative follow-up (p < 0.05). Although the scores of small tear group remained better than those of the medium group at the final postoperative follow-up, the difference was not statistically significant (p > 0.05). Radiographic assessment of the final follow-up demonstrated that the progression rate in the small tear group (8.57%) was significantly lower than that in the medium group (27.50%, p < 0.05), and the retear rate of small tear group (14.29%) was significantly lower than that of the medium tear group (35.00%, p < 0.05).

CONCLUSION: ARCR could effectively improve the quality of life for RA patients with small or medium RCTs, at least in the medium term. Despite the progression of joint destruction in some patients, postoperative retear rates were comparable to those in the general population. ARCR is more likely to benefit RA patients than conservative treatment.

PMID:37232062 | DOI:10.1111/os.13757

Stereotact Funct Neurosurg. 2023 May 16:1-7. doi: 10.1159/000529763. Online ahead of print.

ABSTRACT

INTRODUCTION: Microvascular decompression (MVD) is an efficacious neurosurgical intervention for patients with medically intractable neurovascular compression syndromes. However, MVD may occasionally cause life-threatening or altering complications, particularly in patients unfit for surgical operations. Recent literature suggests a lack of association between chronological age and surgical outcomes for MVD. The Risk Analysis Index (RAI) is a validated frailty tool for surgical populations (both clinical and large database). The present study sought to evaluate the prognostic ability of frailty, as measured by RAI, to predict outcomes for patients undergoing MVD from a large multicenter surgical registry.

METHODS: The American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) database (2011-2020) was queried using diagnosis/procedure codes for patients undergoing MVD procedures for trigeminal neuralgia (n = 1,211), hemifacial spasm (n = 236), or glossopharyngeal neuralgia (n = 26). The relationship between preoperative frailty (measured by RAI and 5-factor modified frailty index [mFI-5]) for primary endpoint of adverse discharge outcome (AD) was analyzed. AD was defined as discharge to a facility which was not home, hospice, or death within 30 days. Discriminatory accuracy for prediction of AD was assessed by computation of C-statistics (with 95% confidence interval) from receiver operating characteristic (ROC) curve analysis.

RESULTS: Patients undergoing MVD (N = 1,473) were stratified by RAI frailty bins: 71% with RAI 0-20, 28% with RAI 21-30, and 1.2% with RAI 31+. Compared to RAI score 19 and below, RAI 20 and above had significantly higher rates of postoperative major complications (2.8% vs. 1.1%, p = 0.01), Clavien-Dindo grade IV complications (2.8% vs. 0.7%, p = 0.001), and AD (6.1% vs. 1.0%, p &lt; 0.001). The rate of primary endpoint was 2.4% (N = 36) and was positively associated with increasing frailty tier: 1.5% in 0-20, 5.8% in 21-30, and 11.8% in 31+. RAI score demonstrated excellent discriminatory accuracy for primary endpoint in ROC analysis (C-statistic: 0.77, 95% CI: 0.74-0.79) and demonstrated superior discrimination compared to mFI-5 (C-statistic: 0.64, 95% CI: 0.61-0.66) (DeLong pairwise test, p = 0.003).

CONCLUSIONS: This was the first study to link preoperative frailty to worse surgical outcomes after MVD surgery. RAI frailty score predicts AD after MVD with excellent discrimination and holds promise for preoperative counseling and risk stratification of surgical candidates. A risk assessment tool was developed and deployed with a user-friendly calculator: <ext-link ext-link-type=”uri” xlink:href=”https://nsgyfrailtyoutcomeslab.shinyapps.io/microvascularDecompression” xmlns:xlink=”http://www.w3.org/1999/xlink”>https://nsgyfrailtyoutcomeslab.shinyapps.io/microvascularDecompression</ext-link>.

PMID:37232028 | DOI:10.1159/000529763

Stereotact Funct Neurosurg. 2023 May 24:1-10. doi: 10.1159/000530398. Online ahead of print.

ABSTRACT

BACKGROUND: Deep brain stimulation (DBS) is a neurosurgical treatment used for the treatment of movement disorders. Surgical and perioperative complications, although infrequent, can result in clinically significant neurological impairment.

OBJECTIVES: In this study, we evaluated the incidence and risk factors of intracranial bleeding in DBS surgery.

METHOD: Medline, EMBASE, and Cochrane were screened in line with PRISMA 2020 guidelines to capture studies reporting on the incidence of hemorrhagic events in DBS. After removing duplicates, the search yielded 1,510 papers. Abstracts were evaluated by two independent reviewers for relevance. A total of 386 abstracts progressed to the full-text screen and were assessed against eligibility criteria. A total of 151 studies met the criteria and were included in the analysis. Any disagreement between the reviewers was resolved by consensus. Relevant data points were extracted and analyzed in OpenMeta [Analyst] software.

RESULTS: The incidence of intracranial bleeding was 2.5% (95% CI: 2.2-2.8%) per each patient and 1.4% (95% CI: 1.2-1.6%) per each implanted lead. There was no statistically significant difference across implantation targets and clinical indications. Patients who developed an intracranial bleed were on average 5 years older (95% CI: 1.26-13.19), but no difference was observed between the genders (p = 0.891). A nonsignificant trend was observed for a higher risk of bleeding in patients with hypertension (OR: 2.99, 95% CI: 0.97-9.19) (p = 0.056). The use of microelectrode recording did not affect the rate of bleeding (p = 0.79).

CONCLUSIONS: In this review, we find that the rate of bleeding per each implanted lead was 1.4% and that older patients had a higher risk of hemorrhage.

PMID:37232022 | DOI:10.1159/000530398

Pediatr Neurosurg. 2023 May 24. doi: 10.1159/000531210. Online ahead of print.

ABSTRACT

Introduction Subependymal giant cell astrocytoma (SEGA) is the most common CNS tumor in patients with tuberous sclerosis complex (TSC). Although these are benign, their proximity to the foramen of Monroe frequently causes obstructive hydrocephalus, a potentially fatal complication. Open surgical resection has been the mainstay of treatment; however, this can cause significant morbidity. The development of mTOR inhibitors has changed the treatment landscape, but there are limitations to their use. Laser interstitial thermal therapy (LITT) is an emerging treatment modality that has shown promise in treatment of a variety of intracranial lesions, including SEGAs. We present a single institution, retrospective study of patients treated for SEGAs with LITT, open resection, mTOR inhibitors, or a combination of these modalities. The primary study outcome was tumor volume at most recent follow up compared with volume at treatment initiation. The secondary outcome was clinical complications associated with treatment modality. Methods Retrospective chart review was performed to identify patients with SEGAs treated at our institution from 2010-2021. Demographics, treatment information and complications were collected from the medical record. Tumor volumes were calculated from imaging obtained at initiation of treatment and at most recent follow up. Kruskal-Wallis non-parametric testing was used to assess differences in tumor volume and follow up duration between groups. Results Four patients underwent LITT (3 with LITT only), three underwent open surgical resection, and four were treated with mTOR inhibitors only. Mean percent tumor volume reduction for each group was 48.6 ± 13.8, 90.7 ± 39.8, and 67.1 ± 17.2%, respectively. No statistically significant difference was identified comparing percent tumor volume reduction between the three groups (p=0.0513). Additionally, there was no statistically significant difference in follow up duration between groups (p=0.223). Only 1 patient in our series required permanent CSF diversion and 4 discontinued or decreased the dose of mTOR inhibitor due to either cost or side effects. Conclusions Our study suggests that LITT could be considered as a treatment option for SEGAs, as it was effective in reducing tumor volume with very few complications. This modality is less invasive than open resection and may be an alternative for patients who are not candidates for mTOR inhibitors. We recommend an updated paradigm for SEGA treatment which includes LITT in select cases after consideration of patient-specific factors.

PMID:37232001 | DOI:10.1159/000531210

BMJ Open Respir Res. 2023 May;10(1):e001625. doi: 10.1136/bmjresp-2023-001625.

ABSTRACT

BACKGROUND: Krebs von den Lungen-6 (KL-6) is a known biomarker for diagnosis and monitoring of interstitial lung diseases. However, the role of serum KL-6 and the mucin 1 (MUC1) variant (rs4072037) in COVID-19 outcomes remains to be elucidated. We aimed to evaluate the relationships among serum KL-6 levels, critical outcomes and the MUC1 variant in Japanese patients with COVID-19.

METHODS: This is a secondary analysis of a multicentre retrospective study using data from the Japan COVID-19 Task Force collected from February 2020 to November 2021, including 2226 patients with COVID-19 whose serum KL-6 levels were measured. An optimal serum KL-6 level cut-off to predict critical outcomes was determined and used for multivariable logistic regression analysis. Furthermore, the relationship among the allele dosage of the MUC1 variant, calculated from single nucleotide polymorphism typing data of genome-wide association studies using the imputation method, serum KL-6 levels and COVID-19 critical outcomes was evaluated.

RESULTS: Serum KL-6 levels were significantly higher in patients with COVID-19 with critical outcomes (511±442 U/mL) than those without (279±204 U/mL) (p<0.001). Serum KL-6 levels ≥304 U/mL independently predicted critical outcomes (adjusted OR (aOR) 3.47, 95% CI 2.44 to 4.95). Moreover, multivariable logistic regression analysis with age and sex indicated that the MUC1 variant was independently associated with increased serum KL-6 levels (aOR 0.24, 95% CI 0.28 to 0.32) but not significantly associated with critical outcomes (aOR 1.11, 95% CI 0.80 to 1.54).

CONCLUSION: Serum KL-6 levels predicted critical outcomes in Japanese patients with COVID-19 and were associated with the MUC1 variant. Therefore, serum KL-6 level is a potentially useful biomarker of critical COVID-19 outcomes.

PMID:37230764 | DOI:10.1136/bmjresp-2023-001625