Statistical Difference In Change Research Articles

Comparison of Intraoperative Radiation Exposure Between Minimally Invasive Chevron Akin (MICA) and Open Procedures for Hallux Valgus Correction

Category: Bunion; Midfoot/Forefoot Introduction/Purpose: The minimally-invasive Chevron-Akin (MICA) procedure for hallux valgus correction is an increasingly popular technique that has yielded comparable radiographic and clinical outcomes to open procedures3–5. Intraoperative radiation dosages for certain foot and ankle surgeries have been reported relative to the international occupational radioprotection thresholds6. In particular, the mean intraoperative radiation exposure during the MIS Scarf osteotomy has been reported to be 14-times greater than open osteotomy7. However, no study to date has reported on the intraoperative radiation exposure during MICA procedures in relation to that of open procedures. Methods: This is a retrospective comparative study from a single institution. Patients underwent a MICA (n=25) or open (n=40) hallux valgus correction by a single foot and ankle fellowship trained surgeon. To account for the learning curve8, the number of intraoperative fluoroscopy shots for the first 50 consecutive MICA procedures were analyzed, and the first 25 procedures were excluded. Four data points were retrieved from the mini C-arm, including 1) number of fluoroscopy shots taken; 2) total fluoroscopy time (s); 3) total radiation dose (mGy); and 4) total dose area product (DAP; mGy*cm2). Preoperative and postoperative radiographs were referenced to measure the hallux valgus (HVA) and intermetatarsal angles (IMA) as previously described.9 Categorical variables were compared using the chi-square test, and continuous variables were compared using Student’s t-test or the Mann-Whitney U test. Analysis of variance was used to determine the statistical significance of differences in the fluoroscopy data between groups. Results: The average total dose absorbed (4.00 vs. 1.34 mGy, p< 0.001), total fluoroscopy time (226 vs. 48.5 s, p< 0.001), and number of fluoroscopy shots (125 vs. 22.3, p< 0.001) were 2.9, 4.6, and 5.6 times greater in the MICA versus the open group, respectively. The total DAP (4.22 vs. 2.56 mGy*cm2, p=0.175) was 1.6 times greater in the MICA group but the difference was not statistically significant. The mean preoperative and postoperative HVA and IMA were greater in the MICA cohort compared to the open cohort. However, there was no statistical difference in change in HVA (MICA -17.43 vs. Open -20.05, p=0.125) or IMA (MICA -8.08 vs. open -9.31, p=0.11) between the two cohorts, with each resulting in normal postoperative angles. Conclusion: In this single surgeon series, the MICA procedure demonstrated significantly greater dose absorbed, total fluoroscopy time, and number of fluoroscopy shots compared to the open procedure. The extent of radiation exposure to the surgeon and the patient in relation to the radioprotection thresholds must be closely monitored to specify the health risks involved with this procedure.

Does thrive by three, a quality-building intervention in childcare centres, strengthen children’s language skills?

ABSTRACT This study examined the effectiveness of the Thrive by Three intervention for 1- to 3-year-old’s language development. Data from 78 childcare centres, 187 toddler classrooms, and 1561 children (91.4% native Norwegian) were included. Results revealed that children in the intervention group had slightly steeper language development than those in the control group, but the difference was not statistically significant. Since previous studies find language stimulation in childcare to differ based on gender, we also examined if the Thrive by Three intervention affected boys and girls differently. We found that effects of the intervention were only present for girls’ language development. Girls in the intervention group had an increase of 17 more words from baseline to post-intervention than those in the control group. There was no statistical difference in change of boys’ language development between the intervention and control group. Results are discussed in light of theories and literature that may explain our findings.

PSUN21 Adrenal Incidentaloma: Is Interval Scanning Warranted?

Abstract Background Adrenal incidentaloma (AI) is an increasingly recognised finding, with pressure on healthcare systems. Earlier guidelines recommended interval scanning and testing to ensure stability. However, the recent European guidelines do not recommend the need for repeat scanning if initial assessment is reassuring. Aim To explore the utility of this guidance on need for interval scanning of benign AI. Methods A retrospective unselected review of AI cases seen in our unit before the launch of the European guidelines was conducted. At that time, a local protocol was in use to characterise scan and test adrenal functions at baseline, and at two years, the scan and endocrine tests were repeated. We compared the baseline scan results with those at two-years. Results We collected data on 54 patients initially identified between 2011 and 2016. Of these, 31 had left-sided lesions, 15 had right-sided lesions and 8 bilateral. Of the left-sided lesions, 16 increased in size over the 2.2-year follow-up period, 4 decreased in size and 17 remained the same. Of the right-sided lesions, 3 increased in size over the follow-up period, 6 decreased in size and 13 remained the same. Of those that increased (left- or right-sided), the largest increase was 5mm. Taking 2 mm as the cut-off for a significant change: on the left, 32/37 (86%) had a change ≤2mm (P<0. 001 for no increase). On the right, 21/22 (95%) had a change ≤2mm (P<0. 001). Using a ≤5% increase as cut-off: 28/37 on the left (P=0. 028) and 20/22 on the right (p<. 001) showed ≤5% increase. There was no statistical difference in change in lesion size in terms of laterality, being indeterminate on initial scanning, gender, age or initial size on presentation. Conclusion We found that there was no significant change in size after two years. Therefore, our data support the European guidelines that repeat scanning is unnecessary. This should be reassuring to patients and provide a more cost-effective service. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

Tranexamic Acid Dosing in Craniosynostosis Surgery: A Systematic Review with Meta-analysis.

Objective:This study aimed to compare operative time, blood loss, and transfusion requirement in patients receiving a high tranexamic acid (TXA) dose of greater than 10 mg/kg versus those receiving a low dose of 10 mg/kg or less.Methods:PubMed, Cochrane Central, and Embase were queried to perform a systematic review with meta-analysis. Studies reporting outcomes of TXA use in craniosynostosis surgery were included. TXA dosing, operative time, blood loss, and transfusion requirement were the primary outcomes studied. Other variables studied included age and types of craniosynostosis.Results:In total, 398 individuals in the included articles received TXA for craniosynostosis surgery. TXA loading doses ranged from 10 mg/kg to 50 mg/kg. Overall, administration of TXA was not associated with changes in operative time, but was associated with decreased blood loss and transfusion requirement on meta-analysis. Comparison of high dose TXA (>10 mg/kg) versus low dose (10 mg/kg or less) showed no statistical differences in changes in operative time, blood loss, or transfusion requirement.Conclusions:Overall, TXA reduced blood loss and transfusion requirement in patients undergoing surgery for craniosynostosis. There was no difference in outcomes between high dose and low dose regimens amongst those receiving TXA. Low dose TXA appears adequate to achieve clinical efficacy with a low adverse event rate.

Transcutaneous Vagus Nerve Stimulation Could Improve the Effective Rate on the Quality of Sleep in the Treatment of Primary Insomnia: A Randomized Control Trial.

(1) Background: The purpose of this study was to investigate the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS) in the treatment of primary insomnia. (2) Methods: This is a single center, randomized, double-blind study. A total of 30 patients diagnosed with primary insomnia were randomly divided into two groups to receive 20 Hz t-VNS in either the auricular concha area (treatment group) or periauricular area (control group), twice a day for 20 min during a one-month study period. The effective rate of treatment, defined as a ≥50% reduction of the Pittsburgh Sleep Index Scale (PSQI) after treatment, was compared between the two groups as the primary outcome. Response rate (defined as ≥10% change in the PSQI score), and changes in the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) scores were also assessed. (3) Results: After one month of treatment, the PSQI score of the treatment group decreased significantly (p = 0.001). The effective rate of the treatment group (73% vs. 27%, p = 0.027) was significantly higher than that of the control group. No statistical differences in changes of HAMA and HAMD scores were detected between the two groups. There were no complications in all patients. (4) Conclusion: T-VNS appeared to be a safe and effective treatment for primary insomnia.

Comparative Clinical and Radiographic Cohort Study: Uniportal Thoracic Endoscopic Laminotomy With Bilateral Decompression by Using the 1-Block Resection Technique and Thoracic Open Laminotomy With Bilateral Decompression for Thoracic Ossified Ligamentum Flavum.

Symptomatic thoracic myelopathy secondary to thoracic ossified ligamentum flavum (OLF) often requires decompression spinal surgery. To compare clinical and radiological outcomes in uniportal endoscopic vs open thoracic decompression for thoracic OLF. Retrospective evaluation of patients who underwent uniportal thoracic endoscopic unilateral laminotomy with bilateral decompression (TE-ULBD) by using the one-block resection technique compared with thoracic open laminotomy (TOL) with bilateral decompression. Radiological outcomes in MRI scan and clinical charts were evaluated. Thirty-five levels of TE-ULBD were compared with 24 levels of TOL. The overall complication rate of TOL was 15% while TE-ULBD was 6.5%. Both TOL and TE-ULBD cohort had significantly improved their visual analog scale (VAS), Oswestry Disability Index, and Japanese Orthopaedic Association (JOA) myelopathy score after operation. Comparative analysis of TE-ULBD performed statistically and significantly better than TOL in improvement of final VAS and JOA scores. The mean difference ± standard deviation of VAS and JOA improvement in final follow-up when compared with preoperative state of TE-ULBD and TOL was 0.717 ± 0.131 and 1.03 ± 0.2, respectively, P < .05. The mean Hirabayashi recovery rates were 94.5% (TE-ULBD) and 56.8% (TOL). There was no statistical difference in change in preoperative and final Oswestry Disability Index and MRI volume at upper endplate, middisk, and lower endplate canal cross-sectional area. Uniportal TE-ULBD achieved significantly improved pain and neurological recovery with sufficient spinal canal decompression, as compared with thoracic open laminectomy for patients with myelopathy secondary to OLF in our cohort.

Safety and Efficacy of Sodium-glucose Cotransporter 2 Inhibitors in Kidney Transplant Recipients With Pretransplant Type 2 Diabetes Mellitus: A Retrospective, Single-center, Inverse Probability of Treatment Weighting Analysis of 85 Transplant Patients

In this retrospective, observational, single-center, inverse probability of treatment weighting (IPTW) analysis study, we compared the outcomes of SGLT2 inhibitors (SGLT2 group) and other OHAs (control group) following KT. A total of 85 recipients with type 2 diabetic nephropathy as the major cause of ESRD before KT who were treated at our institute between October 2003 and October 2019 were screened and included. The variables considered for IPTW were recipient age, sex, body mass index, history of cardiovascular disease, ABO incompatibility, insulin therapy, estimated glomerular filtration rate (eGFR), and hemoglobin A1c (HbA1c) at the initiation of additional OHAs. Primary endpoints were changes in HbA1c, body weight, and eGFR 1 y after the initiation of additional OHAs. After IPTW analysis, there were 26 patients in the SGLT2 group and 59 patients in the control group (n = 85 overall). The body weights were significantly reduced in the SGLT2 group. There was no statistical difference in changes in HbA1c and eGFR. Similarly, there was no significant difference in the incidence of urinary infection, acute rejection, or other side effects between the groups. Our findings suggested that SGLT2 inhibitors reduced the body weight of KT recipients and were used safely without increasing side effects.

Regional Differences of Mechanical Properties in a Biceps Brachii Following Eccentric Exercise

PURPOSE: This study aimed to examine the effects of eccentric exercise (ECC) on the indices of mechanical properties together with markers of exercise-induced muscle damage (EIMD) in different sites of the biceps brachii (BB) muscle.METHODS: ECC using an elbow joint was performed in 13 non-trained, college men. Global symptoms of EIMD were identified through changes in muscle soreness and serum creatine kinase (CK) activity, including muscle function following ECC. To evaluate regional EIMD, muscle swelling and tenderness as well as muscular echo intensity were measured at distal (4 cm above the elbow joint) and middle (30% of the distance from the antecubital crease to the acromion) sites within the BB muscle. A handheld myotonometer was used to estimate changes in mechanical properties, that is, oscillation frequency (F), dynamic stiffness (S), and relaxation time (R), of BB muscles after ECC.RESULTS: A significant difference in the major markers of EIMD, such as muscle soreness and serum CK activity, along with parameters of muscle function, was observed after ECC compared to baseline. Although all indirect markers of regional muscle damage demonstrated meaningful differences between before and after ECC, no statistically significant interaction between the distal and middle sites was observed in any of the markers. After ECC, both distal and middle sites showed significant changes in F, S, and R, but no statistical differences in changes in muscle mechanical properties were observed between localized muscle sites within BB muscles.CONCLUSIONS: Changes in mechanical properties, including regional muscle damage, seem to be uniformly influenced by different anatomical locations within the BB muscle, such as elbow flexors, following ECC.

A comparative evaluation of kambin’s triangle approach versus safe triangle approach for lumbar transforaminal epidural injection in patients with lumbar radiculopathy - A prospective, randomized, double blind study

Background: Epidural injection of steroid and local anaesthetic is a common modality for management of radicular pain. Transforaminal approach is preferred for epidural injection in case of radiculopathy.&#x0D; Aims and Objectives: To compare the effect of the Kambin’s triangle and subpedicular approaches of transforaminal epidural injection (TFEI) in patients of lumbar radiculopathy.&#x0D; Materials and Methods: Forty patients with lumbar radicular pain were enrolled and randomly assigned to each group (Group K for Kambin’s triangle approach and Group S for subpedicular approach). All procedures were performed under fluroscopic guidance. The frequency of complications during the procedure and the effect of TFEI at 2 and 4 weeks after the procedure between the two groups were compared. Short-term outcomes were measured using a visual Analog scale (VAS). Multiple logistic regression analyses were performed to evaluate the relationship between possible outcome predictors and the therapeutic effect.&#x0D; Result: VAS was improved 2 weeks after the injection and continued to improve until 4 weeks in both groups. There were no statistical differences in changes of VAS between these two groups. Spinal nerve pricking occurred in one case of the subpedicular and in none of the cases of the Kambin’s triangle approach (p&lt;0.05).&#x0D; Conclusion: Kambin’s triangle approach is as efficacious as the subpedicular approach for short-term effect and offers considerable advantages (i.e., less spinal nerve pricking during procedure). So, Kambin’s triangle approach may be an alternative method for TFEI in cases where needle tip positioning in the anterior epidural space is difficult.

Umbilical cord blood and cord tissue mesenchymal stromal cells in children with cerebral palsy

Background & Aim: Umbilical cord blood (CB) and mesenchymal stromal cells (MSC) have shown safety in children with cerebral palsy (CP). While early phase clinical trials suggest potential functional benefit, small sample sizes, heterogeneous populations, and variable cell doses have impaired accurate assessment of motor gains following treatment. Aim: Describe change in gross motor function in young children with CP after treatment with high-dose allogeneic unrelated donor CB or allogeneic, third party human cord tissue-derived MSC (hCT-MSC) 12 months post treatment. Methods, Results & Conclusion: We conducted a phase 2 randomized trial of 90 children ages 2-4 years with hypertonic CP due to hypoxic ischemic encephalopathy, periventricular leukomalacia, or in utero stroke/bleed. Randomization, stratified by etiology and severity (Gross Motor Function Classification System (GMFCS) level), was to: (a) 10×107 total nucleated cells (TNC)/kg allogeneic CB at baseline, (b) three doses of 2×106 cells/kg hCT-MSC given at baseline, 3, and 6 months, or (c) Natural History in which 10×107 TNC/kg allogeneic CB was given at one year. Infusions were intravenous and premedicated with diphenhydramine and methylprednisolone without immunosuppression. Primary outcome was change in motor function one-year post enrollment, measured by the Gross Motor Function Measure-66 (GMFM-66). Ninety children (median 3.5 years) were randomized and completed baseline and 6-month evaluations. Due to the COVID pandemic, only 68 completed 12-month assessments. The only adverse events (AEs) related to the cell products were 8 transient infusion reactions (3 CB, 5 hCT-MSC). An additional 95 non-severe AEs and 33 severe AEs were unrelated to the products. At 6 months, there was no statistical difference in change in GMFM-66 scores between Natural History (n=31) and either treatment group (CB n=31, hCTMSC n=28). At 12 months, after adjustment for baseline GMFCS level, GMFM-66 score, and etiology of CP, the mean GMFM-66 score of the hCT- MSC group (n=23) was 1.4 points higher than Natural History (n=25;95% CI: -1.1, 4.0;p=0.27) and the CB group (n=20) was 3.3 points higher than Natural History (95% CI: 0.59, 5.93;p=0.02). High dose allogeneic CB, but not hCT-MSC, infusion is associated with gross motor improvement in young children with CP, consistent with the dose effect in a prior study of autologous CB. A phase 3 randomized placebo-controlled study should be performed to confirm the CB observation.

Reversal of warfarin and direct-acting oral anticoagulants in traumatic intracranial hemorrhage: Four factor prothrombin complex concentrates for all?

Background Patients receiving oral anticoagulation who experience a traumatic intracranial hemorrhage (ICH) should receive anticoagulation reversal. Four factor prothrombin complex concentrate (4FPCC) is indicated for reversal of warfarin, and is frequently used for reversal of direct-acting oral anticoagulants (DOACs). The purpose of this study is to compare the safety and efficacy of 4FPCC reversal for traumatic ICH in DOAC- and warfarin-anticoagulated patients. Methods This was a single-center, retrospective review of adult patients with traumatic ICH who received 4FPCC for reversal of anticoagulation between April 2013 and August 2018. The ICH volume on the pre- and post-reversal head CT scans was measured. The primary endpoint was the incidence of expansion of ICH volume of blood using pre-and post-4FPCC imaging. Results A total of 102 patients meeting inclusion criteria were identified with 75 patients in the warfarin group and 27 patients in the DOAC group. There were no significant differences in baseline characteristics between the groups except DOAC patients had larger ICH volumes at baseline as compared to warfarin patients (23.4 mm3 vs 3.7 mm3, p = 0.0001). There was neither a statistical difference in change in ICH volume pre-and post-4FPCC administration, nor in the rate of &gt;20% ICH expansion between the warfarin and DOAC groups. There was no difference in the rate of adverse events compared between groups. Conclusion There was no difference in the either the change in ICH volume or the rate of &gt;20% ICH expansion in patients receiving 4FPCC for reversal DOAC versus warfarin anticoagulation. Rates of complications were low in both groups.

Is it safe to stop at C7 during multilevel posterior cervical decompression and fusion? – multicenter analysis

Despite a number of studies addressing the anatomical and biomechanical challenges of long segment, posterior cervical fusion surgery, recommendations for appropriate caudal "end level" vary widely. Compare revision rates, patient reported outcomes and radiographic outcomes in patients in whom 3+ level posterior fusions ended in the cervical spine versus those in whom the fusion was extended into the thoracic spine. Multicenter retrospective analysis. Visual analog scale (VAS), Oswestry disability index (ODI), cervical lordosis, C2-C7 sagittal plumbline, T1 slope, and revision rate. We assembled a radiographic and clinical database of patients that had undergone three or more level posterior cervical fusions for degenerative disease from January 2013 to May 2015 at one of four busy spine centers. Only those patients with at least 2 years of postoperative (postop) follow-up were included. Patients were divided into two groups: group I (fusion ending at C6 or C7) and group II (fusion extending into the thoracic spine). All radiographic measurements (cervical lordosis, T1 slope, and C2-C7 sagittal plumbline) were performed by an independent experienced clinical researcher. Two hundred and sixty-four patient cases were reviewed and sorted into the two outlined groups, Group I (n=168) and Group II (n=96). Demographically, mean age, percentage of females, non-smokers and anterior support were greater in Group II than in Groups I (p<.05). Mean estimated blood loss (EBL), operative time (OR) and length of hospital stay (LOS) were significantly higher in Group II (p<.05). Rate of revision was not clinically or statistically significantly different (p>.05) between Group I (11.1%) and Group II (9.4%). The majority of the revision surgeries occurred between 2 to 5 years postop. A greater number of subjacent degeneration/spondylolisthesis events were noted in Group I compared with Group II (3.6% vs. 1.2%). There were significant improvements in mean clinical outcomes (ie, VAS and ODI) at two years postop in both groups, but there were no statistically significant differences between the groups (p>.05). Mean cervical lordosis at 2 years postop improved in all groups (12.8° vs. 14.1°); however, there was no significant statistical difference in change for mean cervical lordosis (2 weeks vs. 2 year postop) between the two groups. Similary, there were no significant statistical differences in change for mean C2-C7 sagittal plumbline and T1 slope (2 weeks vs. 2 year postop) between the two groups(p>.05). Caudal end level did not significantly affect revision rates, patient reported outcomes or radiographic outcomes. Higher EBL, OR, and LOS in group II suggest that, absent focal C7-T1 pathology, extension of posterior cervical fusions into the thoracic spine may not be necessary. Extension of posterior cervical fusions into the thoracic spine may be recommended for higher risk patients with limitations to strong C7 bone anchorage. In others, it is safe to stop at C7.

Effect of newborn screening for critical CHD on healthcare utilisation.

To evaluate the impact of state-mandated policies for pulse oximetry screening on healthcare utilisation, with a focus on use of echocardiograms. Healthcare Cost and Utilisation Project, Statewide Inpatient Databases from 2008 to 2014 from six states. We defined pre- and post-mandate cohorts based on dates when pulse oximetry became mandated in each state. Linear segmented regression models for interrupted time series assessed associations between implementation of the screening and changes in rate of newborns with Critical CHD-negative echocardiogram results. We also evaluated the changes in rate of newborns who underwent echocardiogram but were not diagnosed with any health issues that could cause hypoxemia. We identified 5967 critical CHD-negative echocardiograms (2847 and 3120 in the pre- and post-mandate periods, respectively). Our models detected a statistically significant increasing trend in rate of critical CHD-negative echocardiograms in the pre-mandate period (Incidence Rate Ratio: 1.08, p = 0.02), but did not detect any statistical differences in changes between pre- and post-mandate periods (Incidence Rate Ratio: 0.93, p = 0.14). Among non-Whites, an increasing trend of Critical CHD-negative echocardiogram during the pre-mandate period was detected (Incidence Rate Ratio 1.12, p < 0.01) and was attenuated during the post-mandate period (Incidence Rate Ratio 0.89, p = 0.02). Similar results were observed in the sensitivity analyses among both Whites and non-Whites. Results suggest that mandatory state screening policies are associated with reductions in false-positive screening rates for hypoxemic conditions, with reductions primarily attributed to trends among non-Whites.

630-P: Targeting Workload Experienced by Diabetes Camp Medical Staff: A Novel Training Curriculum

More than 5700 children with diabetes attend American Diabetes Association (ADA) camps each year. Training volunteer medical staff has become more challenging given the rapid advances in diabetes technology. Through a prospective, multi-site pilot study at 4 ADA camps, we assessed the efficacy of an educational bundle of online interactive cases with in-situ simulation in preparing medical volunteers for management of type 1 diabetes (T1D). We hypothesized that our curriculum would reduce the workload necessary to manage children with T1D as measured by the NASA-Task load index (TLX), a validated workload assessment tool comprised of 6 self-rated scales; mental, physical, and temporal demand, performance, effort, and frustration. No statistical difference in change in workload was observed between the intervention and control groups (Table 1). However, both groups were small and had different experiences prior to camp. The reduction in temporal demand reported by the intervention group by the end of camp may signal an impact among medical providers. Future interventions, with larger, more balanced groups, could evaluate timing of TLX change and the effect on medical staff’s camp experience and patient care. Disclosure E.S. Atwood: Research Support; Self; American Diabetes Association. N.M. Sheanon: Research Support; Self; American Diabetes Association. S. Amanat: None. J.C. Khoury: None. M. Klein: None.

Effect of early integration of specialized palliative care into standard oncologic treatment on the quality of life of patients with advanced head and neck cancers: A phase III randomized controlled trial.

12013 Background: Early palliative care is an important aspect of palliative treatment but has never been evaluated in head and neck cancer. Hence we performed this study. Methods: This was an open-label phase 3 randomised study which enrolled adult patients with squamous cell carcinoma of the head and neck region which warranted palliative systemic therapy. They were 1:1 allocated to either systemic therapy with (EPC arm) or without the addition of early palliative care service (STD arm). Patients were administered the Edmonton Symptom Assessment Scale (ESAS-r) and FACIT HN questionnaire at baseline and 4 weekly thereafter for 12 weeks. The primary endpoint was change in the quality of life (QOL) measured using FACIT HN 12 weeks after randomization. The secondary endpoints were changed in symptom burden at 12 weeks in ESAS-r and overall survival. A repeated-measures analysis of covariance (ANCOVA) was performed to examine the effects of arm and stratum on change in QOL (or symptom score), after controlling for baseline score. Results: Ninety patients were randomised in each arm between 1st June 2016 to 14th August 2017. The compliance with the questionnaires was 100% at baseline. In EPC arm the 70 patients were alive at 3 months and 67 (95.7%) completed the FACIT HN and 64 (91.4%) completed ESAS-r questionnaires. While in the STD arm out of 69 alive the corresponding figures were 61(88.4%) and 59 (85.5%) respectively. There was no statistical difference in change in QOL scores and ΔESAS-r at 12 weeks between the 2 arms (Table). The median overall survival was similar between the 2 arms. (Hazard ratio for death-1.006 (95%CI 0.7347-1.346)). Conclusion: In this phase 3 study, integration of early palliative care in head and neck cancer patients did not result in improvement in the quality of life scores, symptom scores or overall survival. Clinical trial information: CTRI/2016/03/006693 . [Table: see text]

Efficacy and safety of febuxostat for treatment of asymptomatic hyperuricemia among kidney transplant patients: A meta‐analysis of observational studies

The objective of this meta-analysis of observational studies was to evaluatethe efficacy and safety profiles of febuxostat in treating hyperuricemia among kidney transplant patients. We conducted electronic searches in PubMed, Embase, and Cochrane Central Register of Controlled Trials from January 1960 to July 2019 to identify studies that investigated the effects of febuxostat in kidney transplant patients on uric acid as well as safety profiles including estimated glomerular filtration rate (eGFR), hemoglobin level (Hb), white blood cell counts (WBC), liver enzymes, and trough level of tacrolimus. Seven observational studies with 367 participants were included in this meta-analysis. Compared with allopurinol, the febuxostat group demonstrated a higher odds of achieving target uric acid levels lower than 6mg/dL within 12months (OR=2.9, P=.004). However, there was no statistical difference in change of uric acid (WMD=-1.0mg/dL/y, P=.32) and change in allograft eGFR within a year (WMD=0.01mL/min/1.73m2 /y, P=.98) between febuxostat and allopurinol. Regarding safety profiles, there were no statistical differences in eGFR, Hb, WBC, liver enzymes (AST, ALT), and trough level of tacrolimus between baseline and at the study end. Only one study reported suspected graft loss among febuxostat group. Among kidney transplant patients, treating hyperuricemia with febuxostat showed a higher odds of reaching the target of serum uric acid<6mg/dL compared with allopurinol without causing significant side effects including change in tacrolimus level, liver function, decline in renal graft function, and bone marrow function.

Real-time hemodynamic effects of 1:100,000 and 1:200,000 injectable epinephrine and placement of topical 1:1000 epinephrine pledgets in patients undergoing endoscopic sinus and skull-base surgery: a randomized, prospective study.

Intranasal injection of epinephrine and placement of topical epinephrine pledgets are methods to improve visualization during endoscopic sinonasal surgery. Studies comparing the hemodynamic effects of these vasoconstrictors using intraoperative arterial line monitoring are lacking. Twenty-eight patients undergoing endoscopic skull-base surgery were enrolled in a prospective, randomized study. Patients were randomized to have either 2 mL of 1:100,000 or 2 mL of 1:200,000 epinephrine injected intranasally. Hemodynamic parameters, including pulse, systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP), were collected using intraoperative arterial line monitoring for 5 minutes. Afterward, 1:1000 topical epinephrine-soaked pledgets were placed in both groups, and the same parameters were collected for another 5 minutes. There was no statistical difference in change in pulse, SBP, DBP, and MAP between the 1:100,000 and 1:200,000 epinephrine groups. However, epinephrine injections did cause an increase in all hemodynamic parameters when compared with baseline (p < 0.05). Topical epinephrine pledgets placed after injection of epinephrine did not have any significant hemodynamic effects, except for 2 of 28 patients who had a >75-mmHg increase in SBP. No preoperative characteristics were identified that predicted sensitivity to epinephrine. There is no statistical difference in changes in hemodynamic parameters between injecting epinephrine 1:100,000 compared with 1:200,000 during endoscopic sinonasal surgery. In a subset of patients, placement of topical 1:1000 epinephrine pledgets had significant hemodynamic elevation requiring intervention and thus should be used judiciously depending on patient comorbidities.

The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX)

IntroductionCligosiban is an orally administered, centrally penetrant oxytocin receptor antagonist being developed to treat premature ejaculation (PE). AimTo determine the efficacy of 3 dose levels of cligosiban caplets to prolong intravaginal ejaculation latency time (IELT) and improve patient-reported outcomes in men with lifelong PE. MethodsPatients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments. Patients were eligible for the study if their stopwatch-assessed IELT was ≤1 minute in ≥75% of intercourse attempts and if they met other diagnostic criteria for lifelong PE. Eligible patients (target 220 evaluable) were randomized to double-blind cligosiban 400, 800, or 1200 mg or matching placebo caplets (to be taken 1 to 6 hours prior to sexual activity). Assessments were conducted at 2, 4, and 8 weeks. Main Outcome MeasureEfficacy measures were comprised of IELT, self-rating of ejaculation control and ejaculation-related distress (recorded in an electronic diary after each intercourse attempt), premature ejaculation profile, Patient’s Global Impression of Severity, and the Clinical Global Impression of Change. ResultsThere were no clinically or statistically significant differences between cligosiban (at any dose level) and placebo for the primary endpoint (change in geometric IELT) or any of the secondary endpoints. Cligosiban was well tolerated with a side-effect profile similar to placebo. Clinical ImplicationsThis Phase IIb study failed to demonstrate the potential for cligosiban, an oxytocin antagonist, to successfully treat symptoms of severe lifelong PE at doses up to 1200 mg. Strengths and LimitationsThis was a Phase IIb, randomized, double-blind, placebo-controlled study that was adequately powered but failed to detect a clinically meaningful or statistical difference in change in IELT between cligosiban at 3 dose levels and placebo. This is in contrast to a similarly designed proof-of-concept study where cligosiban was flexibly dosed at doses up to 800 mg and did demonstrate clinically meaningful and statistically significant changes in efficacy parameters. The reasons for this disparity are not known. ConclusionsCligosiban was well tolerated but failed to demonstrate efficacy for the treatment of men with lifelong PE at doses up to 1200 mg.Althof S, Osterloh IH, Muirhead GJ, et al. The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX). J Sex Med 2019; 16:1188–1198.

Platelet-rich plasma (PRP) treatment of noninsertional Achilles tendinopathy in a two case series: no significant difference in effect between leukocyte-rich and leukocyte-poor PRP.

BackgroundThere is a theoretical basis for the treatment of chronic tendinopathies by platelet-rich plasma (PRP), and it can, therefore, be considered a possible treatment of chronic Achilles tendinopathies (CATs), even though the clinical evidence for the use is not clear and, in addition, there is a lack of treatment algorithms and it is unclear which type of PRP is most effective. The objective of this study was through the comparison of two case series to assess: 1) the effect of PRP on CAT and 2) if there is any difference in effect between leukocyte-rich PRP (LR-PRP) and leukocyte-poor PRP (LP-PRP) in the treatment of CAT.Patients and methodsTwo separate series of achilles tenodinopathies treated with either LR-PRP or LP-PRP were evaluated with a natural experiment/quasi-experimental study design, with a short-term (2 months) and long-term (8–42 months) follow-up to assess the effect and stability of the treatment. In total, 84 patients with failed basic treatment for CAT for at least 6 months were treated with either Biomet’s GPS III recovery kit with LR-PRP (36 patients) or with Arthrex ACP LP-PRP (48 patients).ResultsThe overall probability of reaching a minimal clinically important change (MCIC) of at least 30% reduction in visual analog scale (VAS) was in activity (63%) and during rest (81%), and for Victorian Institute of Sport Assessment Scale (VISA-A), it was 61%. There was no statistical difference in change of VISA-A score or VAS between the patients treated with LP-PRP and LR-PRP.ConclusionPRP seems to be a possible treatment when all other treatment regimens have failed, with a reasonably high probability of reaching MCIC. The choice of either LR-PRP or LP-PRP seems to be up to personal preference as there were no significant differences between patients treated with LR-PRP and LP-PRP.

Effective concentration of Ropivacaine for post-operative pain relief in Total knee replacement surgeries using ultra sound guided continuous femoral block – A randomized double blinded study

Introduction: Postoperative pain in total knee replacement surgeries is severe and needs intense analgesia. Of various analgesic techniques available, continuous femoral nerve block is safe and associated with minimal side effects. Objectives: To compare the analgesic effect of various concentrations of ropivacaine using continuous femoral nerve block for post-operative pain relief in total knee replacement surgeries. Methods: 120 patients posted for elective total knee replacement (TKR) surgeries under American Society of Anesthesiologists (ASA) physical classification I or II, under spinal anaesthesia, were randomly allocated into four groups of 30 each. Group 1, 2, 3 and 4 received ropivacaine 0.12%, 0.16%, 0.20% and 0.25% respectively at 10 mL per hour infusion, by ultrasound-guided continuous femoral nerve block. Pain relief was assessed by visual analogue scale (VAS). Analgesic requirement in the post-operative period and hemodynamic changes compared between four groups. Results: There was no statistical difference in change in hemodynamics over time between all four groups. Analgesic requirement was significantly less and VAS score was significantly low in group 3 and group 4. Conclusion: In this study, the minimum effective concentration of ropivacaine when used for pain relief in continuous femoral block in total knee replacement surgeries is found to be 0.20%. Keywords: Analgesia; Knee replacement; Nerve block; Ropivacaine; Ultrasound