Tag: statistics

Aesthetic Plast Surg. 2022 Feb 7. doi: 10.1007/s00266-022-02770-5. Online ahead of print.

ABSTRACT

BACKGROUND: We present our experience on 153 cases of full-thickness anterior blepharotomy with mullerectomy (FTABM) in the treatment of upper eyelid retraction (UER) related to Graves’ ophthalmopathy (GO).

METHODS: We included all the patients who underwent a graded FTABM between 1^st January 2015 and 30^th June 2020 for UER GO-related. The analysis included: pre-/post-operative conjunctival symptoms, epiphora, GO-Quality of Life Questionnaire (QoL), lagophthalmos, marginal reflex distance (MRD-1) index, eyelid symmetry within 1mm. The statistical analysis was designed to detect postoperative improvement in objective and subjective clinical features. Outcomes were analysed through Chi-squared test for dichotomous variables and through Wilcoxon-Mann-Whitney test for continuous variables.

RESULTS: Of the 111 patients, 42 underwent a bilateral procedure, while 69 a monolateral. Conjunctival symptoms were reported in 32% of cases before surgery and in 12.4% after FTABM (p < 0.001). Epiphora was complained by 29.6% of patients preoperatively and in 12.4% postoperatively (p < 0.001). Preoperative lagophthalmos was found in 12.4% (mean value of 0.34 ± 0.76 mm) of eyelids, and in 2.6% (mean value 0.05 ± 0.19 mm) eyelids (p = not significant) postoperatively. Pre-operative GO-QoL was 24.9 ± 4.4 mm; while post-operative GO-QoL was 35.3 ± 5.5 mm (p < 0.001). The MRD-1 varied from 10.12 ± 2.1 mm preoperatively, to 4.3 ± 0.6 mm (p < 0.001) after surgery. Asymmetric palpebral fissure was noted in 94 (84.7%) patients before surgery and in 7 (6.3%) after the procedure (p < 0.001).

CONCLUSION: FTABM is an effective procedure to treat UER GO-related. The technique manages to prevent complications of UER and determine good aesthetics.

LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . Level IV, therapeutic study.

PMID:35129648 | DOI:10.1007/s00266-022-02770-5

Eur Arch Otorhinolaryngol. 2022 Feb 7. doi: 10.1007/s00405-022-07281-2. Online ahead of print.

ABSTRACT

PURPOSE: To determine the long-term outcomes of patients with vestibular schwannomas (VS) after stereotactic radiosurgery (SRS) who experience delayed tumour regrowth.

METHODS: We carried out a retrospective case series in tertiary university settings. We included patients with VS with initial response to SRS and delayed regrowth, assessing a database of 735 patients with VS and 159 patients who had SRS as sole treatment. Following SRS, all patients had clinical follow-up and serial magnetic resonance imaging (MRI). We documented the post-SRS clinical assessment, pre- and post-SRS VS size as per MRI in predetermined time periods, response to treatment and rate of (re-) growth and the final outcome in each case.

RESULTS: We identified six patients with good initial response but delayed VS regrowth at a faster rate than pre-SRS. The mean growth rate for these VS was 0.347 mm/month (range 0.04-0.78 mm/month) prior to treatment; the mean growth rate at the time of delayed re-growth was 0.48 mm/month (range 0.17-0.75 mm/month); this did not reach the level of statistical significance (p = 0.08). This regrowth occurred at a mean time of 42 months (range 36-66 months) post-SRS and stopped 22 months (mean, range 12-36 months) post regrowth detection in all cases.

CONCLUSIONS: Given that delayed post-SRS VS regrowth can occur in approximately 4% of the treated cases, it is important to continue close clinical and radiological follow-up. Despite this abnormal behaviour, VS do stop growing again; still, patients should be made aware of the possibility of this uncommon VS behaviour following SRS.

PMID:35129632 | DOI:10.1007/s00405-022-07281-2

JAMA Pediatr. 2022 Feb 7. doi: 10.1001/jamapediatrics.2021.6308. Online ahead of print.

ABSTRACT

IMPORTANCE: Most parenting programs target parents of children with severe behavioral problems. There is limited evidence on the effectiveness of universal parenting programs, especially for families with low income.

OBJECTIVE: To evaluate the effectiveness of the KeySteps@JC Parent-Child Interaction Program for low-income families in Hong Kong.

DESIGN, SETTING, AND PARTICIPANTS: A parallel, unblinded, cluster, randomized clinical trial was conducted from September 2018 to June 2019. Eight participating preschools in Hong Kong were randomly assigned (1:1) using an online randomization plan generator into intervention (immediate) and waiting list control (delayed) groups. Intervention participants included the parents of children in kindergarten grade 1. The results were processed by an intention-to-treat analysis.

INTERVENTIONS: KeySteps@JC Parent-Child Interaction program.

MAIN OUTCOMES AND MEASURES: The primary outcome was child behavioral problems, which were assessed using the Strength and Difficulties Questionnaire. Secondary outcomes were parental emotion coaching, involvement in child reading and play, and parent stress levels, which were assessed using Chinese-validated versions of the Parent Reading Belief Inventory, the Chinese Parent-Child Interaction Scale, the Emotion-Related Parenting Styles, and the Parental Stress Scale questionnaires. Parents in the intervention group participated in a training program consisting of 20 weekly 1.5-hour sessions on child behavior management, emotion coaching, dialogic reading, and interactive play. The primary hypothesis was that child behavior problems would be reduced after the intervention. The main analysis was a mixed-method regression with group status as the independent variable.

RESULTS: A total of 267 parents (mean age, intervention group: 33.8 years; 95% CI, 32.9-34.7 years; waiting list group: 35.7 years; 95% CI, 34.5-36.9 years) participated in the program. The intervention group included 153 participants (57.3%), and the waiting list group included 114 participants (42.7%). Among the target children (mean age, intervention group: 3.5 years; 95% CI, 3.4-3.5 years; waiting list group: 3.4 years; 95% CI, 3.4-3.5 years), there were 88 boys (57.5%) in the intervention group and 59 boys (51.8%) in the waiting list group. At postintervention, the intervention group reported a statistically significant improvement in children’s behavior (Cohen d, 0.29; 95% CI, 0.04-0.53); parents’ use of emotion-coaching strategies, including feelings of uncertainty or ineffectiveness in emotion socialization (Cohen d, 0.26; 95% CI, 0.01-0.50) and parental rejection of negative emotion (Cohen d, 0.33; 95% CI, 0.08-0.57); and involvement in child reading (Cohen d, 0.17; 95% CI, -0.07 to 0.41).

CONCLUSIONS AND RELEVANCE: The results of this randomized clinical trial provide promising evidence on the effectiveness of a multicomponent parenting intervention in preparing children from low-income families to be more socially and emotionally ready for school.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03615937.

PMID:35129606 | DOI:10.1001/jamapediatrics.2021.6308

Graefes Arch Clin Exp Ophthalmol. 2022 Feb 7. doi: 10.1007/s00417-022-05570-4. Online ahead of print.

ABSTRACT

PURPOSE: To investigate retinal sensitivity changes in eyes with pure cuticular drusen.

METHODS: Multimodal imaging and microperimetry (37-loci grid) data were examined retrospectively to evaluate functional changes in eyes with pure cuticular drusen. Mean sensitivity in the cuticular drusen cohort was compared to age-matched normals. An age- and loci-specific normative reference was created to analyse localised sensitivity deviation.

RESULTS: The mean number loci with relative scotoma in the cuticular drusen cohort (n = 27, mean [SD] age: 48.5 [12.4] years) referenced to normal eyes (n = 80, 53.5 [14.6] years) was 5.5 (95% confidence interval 3.0 to 8.1). However, mean sensitivity was not statistically different to the age-matched normal cohort (95% CI, – 2.3 to + 3.4 dB). The 37-loci grid was stratified into three rings of the approximately same number of loci, and the percentage of cuticular drusen eyes with pointwise deviation was significantly lower in the inner compared to the middle ring (12.3 [5.3]% vs. 17.3 [5.1]%, p < 0.05).

CONCLUSIONS: Eyes with cuticular drusen demonstrated relative scotoma, but mean sensitivity was not affected. Pointwise sensitivity provides a more robust measure of retinal sensitivity than mean sensitivity in cuticular drusen and should be assessed both in the clinic and in future clinical trials.

PMID:35129629 | DOI:10.1007/s00417-022-05570-4

JAMA Netw Open. 2022 Feb 1;5(2):e2147351. doi: 10.1001/jamanetworkopen.2021.47351.

ABSTRACT

IMPORTANCE: Gender disparities exist throughout medicine. Recent studies have highlighted an attainment gap between male and female residents in performance evaluations on Accreditation Council for Graduate Medical Education (ACGME) milestones. Because of difficulties in blinding evaluators to gender, it remains unclear whether these observed disparities are because of implicit bias or other causes.

OBJECTIVE: To estimate the magnitude of implicit gender bias in assessments of procedural competency in emergency medicine residents and whether the gender of the evaluator is associated with identified implicit gender bias.

DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study was performed from 2018 to 2020 in which emergency medicine residency faculty assessed procedural competency by evaluating videos of residents performing 3 procedures in a simulated environment. They were blinded to the intent of the study. Proceduralists were filmed performing each procedure from 2 different viewpoints simultaneously by 2 different cameras. One was a gender-blinded (ie, hands-only) view, and the other a wide-angled gender-evident (ie, whole-body) view. The faculty evaluators viewed videos in a random order and assessed procedural competency on a global rating scale with extensive validity evidence for the evaluation of video-recorded procedural performance.

MAIN OUTCOMES AND MEASURES: The primary outcome was to determine if there was a difference in the evaluation of procedural competency based on gender. The secondary outcome was to determine if there was a difference in the evaluations based on the gender of the evaluator.

RESULTS: Fifty-one faculty evaluators enrolled from 19 states, with 22 male participants (43.1%), 29 female participants (56.9%), and a mean (SD) age of 37 (6.4) years. Each evaluator assessed all 60 procedures: 30 gender-blinded (hands-only view) videos and 30 identical gender-evident (wide angle) videos. There were no statistically significant differences in the study evaluators’ scores of the proceduralists based on their gender, and the gender of the evaluator was not associated with the difference in mean scores.

CONCLUSIONS AND RELEVANCE: In this study, we did not identify a difference in the evaluation of procedural competency based upon the gender of the resident proceduralist or the gender of the faculty evaluator.

PMID:35129594 | DOI:10.1001/jamanetworkopen.2021.47351

JAMA Netw Open. 2022 Feb 1;5(2):e2147363. doi: 10.1001/jamanetworkopen.2021.47363.

ABSTRACT

IMPORTANCE: Infections are proposed to be triggering factors for Kawasaki disease (KD), although its etiological factors remain unknown. Recent reports have indicated a 4- to 6-week lag between SARS-CoV-2 infection and multisystem inflammatory syndrome in children with a similar presentation to that of KD.

OBJECTIVE: To investigate the temporal correlation between KD and viral infections, focusing on respiratory viruses.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study was conducted among individuals aged 0 to 19 years diagnosed with KD between January 2010 and September 2020 from the Korean National Health Insurance Service. Data on infectious disease outbreaks from 2016 to 2019 were collected from the Korea Disease Control and Prevention Agency, Korean Influenza and Respiratory Virus Monitoring System, Korea Enteroviruses Surveillance System, and the Enteric Pathogens Active Surveillance Network in South Korea. Data were analyzed from December 2020 to October 2021.

MAIN OUTCOMES AND MEASURES: National databases for infectious diseases were used for a time-series analysis of the correlation between viral infections and KD. The temporal correlation between infectious disease outbreaks and KD outbreaks was evaluated using the Granger causality test (G-test), which is a useful tool to estimate correlations between 2 time series of diseases based on time lags.

RESULTS: Overall, 53 424 individuals with KD were identified, including 22 510 (42.1%) females and 30 914 (57.9%) males and 44 276 individuals (82.9%) younger than 5 years. Intravenous immunoglobulin-resistant KD was identified in 9042 individuals (16.9%), and coronary artery abnormalities were identified in 384 individuals (0.7%). Of 14 infectious diseases included in the analyses, rhinovirus infection outbreaks were identified as significantly correlated at 1 to 3 months before KD outbreaks in South Korea (r = 0.3; 1 month: P < .001; 2 months: P < .001; 3 months: P < .001). Outbreaks of respiratory syncytial virus infection were identified as significantly correlated with KD outbreaks by 2 months (r = 0.5; 2 months: P < .001). Additionally, varicella outbreaks were identified as significantly correlated at 2 and 3 months before KD outbreaks (r = 0.7; 2 months: P < .001; 3 months: P < .001).

CONCLUSIONS AND RELEVANCE: In this cohort study with a time series analysis of children and youth in South Korea with KD, respiratory infections caused by rhinovirus and respiratory syncytial virus and varicella outbreaks were significantly correlated with KD at 1 to 3 months before KD outbreaks.

PMID:35129593 | DOI:10.1001/jamanetworkopen.2021.47363

Rev Esc Enferm USP. 2022 Feb 4;56:e20210474. doi: 10.1590/1980-220X-REEUSP-2021-0474. eCollection 2022.

ABSTRACT

OBJECTIVE: To analyze the effects of an educational intervention in the light of the Meaningful Learning Theory on the knowledge and attitude of Primary Health Care physicians and nurses in the assessment of the degree of physical disability in leprosy.

METHOD: An intervention study of the before-and-after type, conducted with 122 professionals (84 nurses and 38 physicians) from the Primary Health Care of João Pessoa, Paraíba, in a training course on the assessment of the degree of physical disability in leprosy. The data were collected with the research’s own instrument validated and analyzed by the chi-square adherence and proportion test, with a 5% significance level.

RESULTS: There was an increase in the scores of all items of the instrument, with a statistically significant difference (p < 0.05) in 20 of the 32 items, with emphasis on those related to the professional’s technical ability to conduct the stages of anamnesis, palpation of peripheral nerves, sensory and motor evaluation. It is also noteworthy that, after the intervention, 5 items obtained 100% of correct answers.

CONCLUSION: The educational intervention grounded on the Meaningful Learning Theory improved the health professionals’ knowledge and attitude in the assessment of the degree of physical disability in people with leprosy.

PMID:35129573 | DOI:10.1590/1980-220X-REEUSP-2021-0474

Ann Surg. 2021 Oct 8. doi: 10.1097/SLA.0000000000005251. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the survival impact of low-titer group O whole blood (LTOWB) in injured pediatric patients who require massive transfusion.

SUMMARY BACKGROUND DATA: Limited data are available regarding the effectiveness of LTOWB in pediatric trauma.

METHODS: A prospective observational study of children requiring massive transfusion after injury at UPMC Children’s Hospital of Pittsburgh, an urban academic pediatric Level 1 trauma center. Injured children ages 1-17 years who received a total of >40 mL/kg of LTOWB and/or conventional components over the 24 hours after admission were included. Patient characteristics, blood product utilization and clinical outcomes were analyzed using Kaplan-Meier survival curves, log rank tests and Cox proportional hazards regression analyses. The primary outcome was 28-day survival.

RESULTS: Of patients analyzed, 27/80 (33%) received LTOWB as part of their hemostatic resuscitation. The LTOWB group was comparable to the component therapy group on baseline demographic and physiologic parameters except: older age, higher body weight and lower red blood cell and plasma transfusion volumes. After adjusting for age, total blood product volume transfused in 24 hours, admission base deficit, international normalized ratio (INR) and injury severity score (ISS), children who received LTOWB as part of their resuscitation had significantly improved survival at both 72 hours and 28 days post-trauma (Adjusted Odds Ratio (AOR) 0.23, p = 0.009 and AOR 0.41, p = 0.02, respectively); 6-hour survival was not statistically significant (AOR = 0.51, p = 0.30). Survivors at 28-days in the LTOWB group had reduced hospital LOS, ICU LOS and ventilator days compared to the CT group.

CONCLUSIONS: Administration of LTOWB during the hemostatic resuscitation of injured children requiring massive transfusion was independently associated with improved 72-hour and 28-day survival.

PMID:35129530 | DOI:10.1097/SLA.0000000000005251

Ann Surg. 2021 Oct 13. doi: 10.1097/SLA.0000000000005254. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine if minimally invasive right colectomy with intracorporeal anastomosis improves postoperative recovery compared to extracorporeal anastomosis.

BACKGROUND: Previous trials have shown that intracorporeal anastomosis improves postoperative recovery; however, it has not yet been evaluated in a setting with optimized perioperative care or with patient-related outcome measures.

METHODS: This was a multicenter, triple-blind, randomized clinical trial at two high-volume colorectal centers with strict adherence to optimized perioperative care pathways. The patients underwent robotic right colectomy with either intracorporeal or extracorporeal anastomosis. The primary outcome was patient-reported postoperative recovery measured using the “Quality of Recovery-15” questionnaire (QoR-15). ClinicalTrials.gov NCT03130166.

RESULTS: A total of 89 patients were randomized and analyzed according to the “Intention-to-treat”-principle. We found no statistically significant differences in patient-reported recovery between the groups. Postoperative pain, nausea, time to ambulation, time to first passage of flatus/stool, length of hospital stay, and pathophysiological tests showed no differences either. The duration of time to create the anastomosis was significantly longer with intracorporeal anastomosis (17 vs. 13 min, P = .003), while all other intraoperative, postoperative, and pathology variables showed no difference.

CONCLUSION: There were no significant differences in postoperative recovery between the two groups.

PMID:35129520 | DOI:10.1097/SLA.0000000000005254

Ann Surg. 2021 Oct 8. doi: 10.1097/SLA.0000000000005240. Online ahead of print.

ABSTRACT

OBJECTIVE: : Economic evaluation of early surgery compared to the endoscopy-first approach in chronic pancreatitis.

SUMMARY BACKGROUND DATA: In patients with painful chronic pancreatitis and a dilated main pancreatic duct, early surgery, as compared with an endoscopy-first approach, leads to more pain reduction with fewer interventions. However, it is unknown if early surgery is more cost-effective than the endoscopy-first approach.

METHODS: The multicenter Dutch ESCAPE trial randomized patients with chronic pancreatitis and a dilated main pancreatic duct between early surgery (surgery within 6 weeks) or the endoscopy-first approach in 30 centers (April 2011 – September 2016). Healthcare utilization was prospectively recorded up to 18 months after randomization. Unit costs of resources were determined, and cost-effectiveness and cost-utility analyses were performed from societal and healthcare perspectives. Primary outcomes were the costs per unit decrease on the Izbicki pain score and per gained quality-adjusted life-year.

RESULTS: In total, 88 patients were included in the analysis, with 44 patients randomized to each group. Total costs were lower in the early surgery group but did not reach statistical significance (mean difference €????4,815 (95 per cent bias-corrected and accelerated confidence interval €????13,113 to €3,411; P=0.25). Early surgery had a probability percentage of 88.4% of being more cost-effective than the endoscopy-first approach at a willingness-to-pay threshold of €0 per day per unit decrease on the Izbicki pain score. The probability percentage per additional gained QALY was 75.7% at a willingness-to-pay threshold of €50,000.

CONCLUSION: In patients with painful chronic pancreatitis and a dilated main pancreatic duct, early surgery was more cost-effective than the endoscopy-first approach.

PMID:35129523 | DOI:10.1097/SLA.0000000000005240