Category: Statistics

Med Princ Pract. 2021 Jun 23. doi: 10.1159/000517976. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of the study was to ascertain the effect of nasal polyposis on cardiac functions.

MATERIAL AND METHODS: A prospective randomized interventional open-label endpoint-controlled study was conducted in an academic tertiary care hospital. Thirty-one patients with chronic rhinosinusitis with nasal polyposis were enrolled and administered fluticasone furoate nasal spray for 3 weeks before randomly segregation into surgical or medical group. The treatment continued for 3 months in both groups. The SNOT-22 (Sino-Nasal Outcome Test-22) score, polyp grade, and right ventricular and pulmonary arterial functions were recorded in both groups before and after 3 months of the intervention.

RESULTS: Both groups had significant improvement in SNOT-22 scores after 3 months of intervention. Both groups showed improvement in cardiac functions, but statistical significance was found only in subjects who underwent surgery.

CONCLUSION: Nasal polyp affects cardiac functions, and this needs further evaluation and research through studies on large samples.

PMID:34348323 | DOI:10.1159/000517976

Pain. 2021 Aug 3. doi: 10.1097/j.pain.0000000000002426. Online ahead of print.

ABSTRACT

Several different reporting biases cited in scientific literature have raised concerns about the overestimation of effects and the subsequent potential impact on the practice of evidence-based medicine and human health. Up to 7-8% of the population experiences neuropathic pain, and established treatment guidelines are based predominately on published, clinical trial results. Therefore, we examined published randomized controlled trials (RCTs) of first-line drugs for neuropathic pain and assessed the relative proportions with statistically significant (i.e., positive) and non-significant (i.e., negative) results and their rates of citation. We determined the relationships between reported study outcome and the frequency of their citations with journal impact factor, sample size, time to publication after study completion, and study quality metrics. We also examined the association of study outcome with maximum study drug dosage and conflict of interest. We found that of 107 published RCTs, 68.2% reported a statistically significant outcome regarding drug efficacy for chronic peripheral and central neuropathic pain. Positive studies were cited nearly twice as often as negative studies in the literature (P=0.01), despite similar study sample size, quality metrics, and publication in journals with similar impact factors. The time to publication, journal impact factor, and conflict of interest did not differ statistically between positive and negative studies. Our observations that negative and positive RCTs were published in journals with similar impact at comparable time-lags after study completion are encouraging. However, the citation bias for positive studies could affect the validity and generalization of conclusions in literature and potentially influence clinical practice.

PMID:34348355 | DOI:10.1097/j.pain.0000000000002426

Photodiagnosis Photodyn Ther. 2021 Aug 1:102472. doi: 10.1016/j.pdpdt.2021.102472. Online ahead of print.

ABSTRACT

Background Photodynamic therapy (PDT) mediated by 5-aminolevulinic acid (5-ALA) is a possible minimally-invasive treatment for cervical intraepithelial neoplasia (CIN). The present study was carried out to investigate the effect of 5-ALA-PDT on CIN2 and the influencing factors of 5-ALA-PDT. Methods Patients diagnosed as CIN2 who met the inclusion criteria were enrolled in this study sequentially from January 2019 to April 2020. Patients were treated by PDT or cryotherapy according to their intentions. The primary endpoint was pathological regression. The secondary endpoint was HPV clearance. Affecting factors of the efficacy of PDT and adverse events were also assessed during treatment. Results A total of 210 patients were enrolled, including 97 patients in PDT group and 101 patients in cryotherapy group, with 12 patients excluded. There was no statistical difference in population characteristics. The pathological regression rate in PDT group was 92.0% (80/87), compared with 81.4% (79/97) in cryotherapy group (P <0.05). The HPV clearance rate was 64.4% (56/87) in PDT group and 57.8% (56/97) in cryotherapy group (P =0.36). The main side effects of PDT were abdominal pain (24.1%, 21/87) and increased vaginal secretions (23.0%, 20/87). On univariate analysis, the risk for lesions persisting at 6 months after PDT was increased by recurrent genital tract inflammation (P =0.004), smoking or passive smoking (P =0.020), and multicentric lesions (P = 0.020). Conclusion PDT can be a safe and efficient treatment for CIN2. Risk factors for persisting HSIL after PDT include recurrent genital tract inflammation, smoking or passive smoking, and multicentric lesions.

PMID:34348187 | DOI:10.1016/j.pdpdt.2021.102472

Med Image Anal. 2021 Jul 27;73:102187. doi: 10.1016/j.media.2021.102187. Online ahead of print.

ABSTRACT

Radiation exposure in positron emission tomography (PET) imaging limits its usage in the studies of radiation-sensitive populations, e.g., pregnant women, children, and adults that require longitudinal imaging. Reducing the PET radiotracer dose or acquisition time reduces photon counts, which can deteriorate image quality. Recent deep-neural-network (DNN) based methods for image-to-image translation enable the mapping of low-quality PET images (acquired using substantially reduced dose), coupled with the associated magnetic resonance imaging (MRI) images, to high-quality PET images. However, such DNN methods focus on applications involving test data that match the statistical characteristics of the training data very closely and give little attention to evaluating the performance of these DNNs on new out-of-distribution (OOD) acquisitions. We propose a novel DNN formulation that models the (i) underlying sinogram-based physics of the PET imaging system and (ii) the uncertainty in the DNN output through the per-voxel heteroscedasticity of the residuals between the predicted and the high-quality reference images. Our sinogram-based uncertainty-aware DNN framework, namely, suDNN, estimates a standard-dose PET image using multimodal input in the form of (i) a low-dose/low-count PET image and (ii) the corresponding multi-contrast MRI images, leading to improved robustness of suDNN to OOD acquisitions. Results on in vivo simultaneous PET-MRI, and various forms of OOD data in PET-MRI, show the benefits of suDNN over the current state of the art, quantitatively and qualitatively.

PMID:34348196 | DOI:10.1016/j.media.2021.102187

Int J Radiat Oncol Biol Phys. 2021 Aug 1:S0360-3016(21)02600-6. doi: 10.1016/j.ijrobp.2021.07.1698. Online ahead of print.

ABSTRACT

PURPOSE/OBJECTIVES: Pancreatic stereotactic body radiation therapy (SBRT) is limited to gross tumor without elective coverage for subclinical disease. Given a better understanding of recurrence patterns, we hypothesized that the addition of elective nodal irradiation (ENI) to pancreatic SBRT would be tolerable and would decrease locoregional progression.

MATERIALS/METHODS: We conducted a retrospective 1:2 propensity-matched cohort study to compare toxicity and locoregional progression among patients treated with pancreatic SBRT with or without ENI. In the SBRT+ENI cohort, an elective target volume was delineated per RTOG guidelines and treated to 25 Gy in 5 fractions alongside 40 Gy in 5 fractions to gross disease. The primary outcome was the cumulative incidence of locoregional progression, with death as a competing risk.

RESULTS: Among 135 candidate controls treated with SBRT alone, 100 were propensity-matched to 50 patients treated with SBRT+ENI. All patients completed SBRT. Median potential radiographic follow-up was 28 months. The incidence of late and serious acute toxicity were similar between matched cohorts. However, SBRT+ENI was associated with a statistically significant increase in acute grade 1-2 nausea (60% vs. 20%, p<0.001). The 24-month cumulative incidences of locoregional progression with and without ENI were 22.6% (95% confidence interval [CI]: 10.0-35.1%) vs. 44.6% (95% CI: 34.8-54.4%, multivariable-adjusted hazard ratio 0.39, 95% CI 0.18-0.87, p=0.021). This was stable in sensitivity analyses of uniform prescription dose, multiagent chemotherapy, and resectability. There were fewer peripancreatic (0% vs. 7%), porta hepatis (2% vs. 7%), and peri-aortic/aortocaval (5% vs. 12%) recurrences after SBRT+ENI, but no difference in survival.

CONCLUSIONS: Pancreatic SBRT+ENI was tolerable and did not increase late or serious acute toxicity relative to a matched cohort undergoing SBRT alone, but did increase acute grade 1-2 nausea. The addition of ENI to SBRT was associated with decreased locoregional progression but not improved survival. Further studies are warranted to determine if ENI offers meaningful benefit.

PMID:34348171 | DOI:10.1016/j.ijrobp.2021.07.1698

J Clin Epidemiol. 2021 Aug 1:S0895-4356(21)00235-3. doi: 10.1016/j.jclinepi.2021.07.019. Online ahead of print.

NO ABSTRACT

PMID:34348179 | DOI:10.1016/j.jclinepi.2021.07.019

Arch Phys Med Rehabil. 2021 Aug 1:S0003-9993(21)01313-7. doi: 10.1016/j.apmr.2021.07.788. Online ahead of print.

ABSTRACT

OBJECTIVE: To identify the incidence of dysphagia after ischemic stroke and determine factors affecting the presence of dysphagia.

DESIGN: Retrospective case-control study. This was an interim analysis of a prospective multicenter Korean stroke cohort.

SETTING: Acute care university hospitals.

PARTICIPANTS: Patients (N=6000) with first-ever acute ischemic stroke. Patients were divided into two groups according to the presence or absence of dysphagia confirmed at 7 days after onset using the American Speech-Language-Hearing Association National Outcomes Measurement System (ASHA-NOMS) scale, which was determined after conducting screening or standardized tests.

INTERVENTIONS: Not applicable.

MAIN OUTCOME MEASURES: Age at stroke onset, body mass index (BMI), premorbid modified Rankin Scale (mRS), brainstem lesions, National Institutes of Health Stroke Scale (NIHSS), post-stroke mRS, and ASHA-NOMS swallowing level at post-stroke day 7 were evaluated.

RESULTS: Among ischemic stroke patients, 32.3% (N=1940) had dysphagia at 7 days after stroke onset. At discharge, 80.5% (N=1561) still had dysphagia. The prediction model for the presence of dysphagia identified age at onset, underweight (BMI < 18.5 kg/m²), premorbid mRS, brainstem lesions, and NIHSS as independent predictors. The odds ratio (OR) for the presence of dysphagia significantly increased with underweight (OR [95% confidence interval]: 1.6684 [1.27-2.20]), increased age at onset (1.0318 [1.03-1.04]), premorbid mRS (1.1832 [1.13-1.24]), brainstem lesions (1.6494 [1.39-1.96]), and NIHSS (1.2073 [1.19-1.23]).

CONCLUSIONS: The incidence of dysphagia after ischemic stroke was 32.3%. The prediction model for the presence of dysphagia identified age, low BMI, premorbid disabilities, brainstem lesions, and NIHSS as predictive factors.

PMID:34348122 | DOI:10.1016/j.apmr.2021.07.788

J Affect Disord. 2021 Jul 9;294:737-744. doi: 10.1016/j.jad.2021.06.086. Online ahead of print.

ABSTRACT

BACKGROUND: Google Trends data are increasingly used by researchers as an indicator of population mental health, but few studies have investigated the validity of this approach during a public health emergency.

METHODS: Relative search volumes (RSV) for the topics depression, anxiety, self-harm, suicide, suicidal ideation, loneliness, and abuse were obtained from Google Trends. We used graphical and time-series approaches to compare daily trends in searches for these topics against population measures of these outcomes recorded using validated self-report scales (PHQ-9; GAD-7; UCLA-3) in a weekly survey (n = ~70,000) of the impact COVID-19 on psychological and social experiences in the UK population (21/03/2020 to 21/08/ 2020).

RESULTS: Self-reported levels of depression, anxiety, self-harm/suicidal ideation, self-harm, loneliness and abuse decreased during the period studied. There was no evidence of an association between self-reported anxiety, self-harm, abuse and RSV on Google Trends. Trends in Google topic RSV for depression and suicidal ideation were inversely associated with self-reports of these outcomes (p = 0.03 and p = 0.04, respectively). However, there was statistical and graphical evidence that self-report and Google searches for loneliness (p < 0.001) tracked one another.

LIMITATIONS: No age/sex breakdown of Google Trends data available. Survey respondents were not representative of the UK population and no pre-pandemic data were available.

CONCLUSION: Google Trends data do not appear to be a useful indicator of changing levels of population mental health during a public health emergency, but may have some value as an indicator of loneliness.

PMID:34348169 | DOI:10.1016/j.jad.2021.06.086

J R Soc Med. 2021 Aug 4:1410768211032589. doi: 10.1177/01410768211032589. Online ahead of print.

ABSTRACT

OBJECTIVE: Six per cent of hospital patients experience a patient safety incident, of which 12% result in severe/fatal outcomes. Acutely sick patients are at heightened risk. Our aim was to identify the most frequently reported incidents in acute medical units and their characteristics.

DESIGN: Retrospective mixed methods methodology: (1) an a priori coding process, applying a multi-axial coding framework to incident reports; and, (2) a thematic interpretative analysis of reports.

SETTING: Patient safety incident reports (10 years, 2005-2015) collected from the National Reporting and Learning System, which receives reports from hospitals and other care settings across England and Wales.

PARTICIPANTS: Reports describing severe harm/death in acute medical unit were identified.

MAIN OUTCOME MEASURES: Incident type, contributory factors, outcomes and level of harm were identified in the included reports. During thematic analysis, themes and metathemes were synthesised to inform priorities for quality improvement.

RESULTS: A total of 377 reports of severe harm or death were confirmed. The most common incident types were diagnostic errors (n = 79), medication-related errors (n = 61), and failures monitoring patients (n = 57). Incidents commonly stemmed from lack of active decision-making during patient admissions and communication failures between teams. Patients were at heightened risk of unsafe care during handovers and transfers of care. Metathemes included the necessity of patient self-advocacy and a lack of care coordination.

CONCLUSION: This 10-year national analysis of incident reports provides recommendations to improve patient safety including: introduction of electronic prescribing and monitoring systems; forcing checklists to reduce diagnostic errors; and increased senior presence overnight and at weekends.

PMID:34348052 | DOI:10.1177/01410768211032589

J Long Term Eff Med Implants. 2021;31(2):71-79. doi: 10.1615/JLongTermEffMedImplants.2021035972.

ABSTRACT

Tooth loss has become one of the most raising issues to be brought up in dentistry, by both patients and dentists. Teeth are considered to be important in case of function and esthetics. Compromise to the dentition would raise social disturbances for the individual. Dental implants are surgical fixtures or artificial tooth roots that are placed into the jawbone. It is one of the best methods of tooth replacement. When considering implants, the dentist must approach it with a multidisciplinary treatment plan. They should consider factors such as age, gender, habit, systemic diseases, oral hygiene, placement site and technique, bone width and bone height, bone density, etc. complications for implant surgery would include bleeding, infections, pain, breakage, etc. A single center retrospective study was done in an institutional setting. The data for the study was retrieved from the college’s patient records management software. All patients undergoing implant surgery in the posterior mandibular region were considered. The patients age, gender, implant site, bone width, and bone height were taken into account as variables. The data received was analyzed using SPSS. A total of 737 patients were considered in the study, 383 being male patients and remaining 354 being female patients. the right and left molar teeth were more commonly replaced in comparison to premolars. The association between the primary stability and bone density was statistically significant (p < 0.05). Within the limitations of the study, males had better bone density than females and D2 bone density was predominantly seen in both males and females and between the age group between 26 to 40 years. D2 bone density is seen in both left and right molar regions. Primary stability was associated with the implant length, width and bone density.

PMID:34348015 | DOI:10.1615/JLongTermEffMedImplants.2021035972