Early Intervention Group Research Articles

Cardiovascular outcomes of early versus delayed coronary intervention in low to intermediate-risk patients with STEMI in Thailand: a randomised trial

BackgroundThe benefit of an early coronary intervention after streptokinase (SK) therapy in low to intermediate-risk patients with ST-elevation myocardial infarction (STEMI) still remains uncertain. The current study aimed to evaluate...

Effect of early nutrition intervention on advanced nasopharyngeal carcinoma patients receiving chemoradiotherapy.

e17504 Background: Patients with nasopharyngeal carcinoma (NPC) frequently developed the problem of malnutrition at the time of diagnosis. Chemoradiotherapy (CRT) can even worsen the situation. Therefore, nutritional intervention should be applied to prevent CRT-associated weight loss and interruption of CRT. However, it is still controversial if early nutritional intervention is beneficial to NPC patients with CRT. This study is to investigate the influence of early nutritional intervention on advanced NPC patients with CRT by evaluating the nutritional status and CRT treatment tolerance. Methods: A cohort of 78 stage III-IV nasopharyngeal carcinoma patients was divided into early (n = 46) and late (n = 32) nutrition intervention groups. The early group of patients received nutritional support at the beginning of CRT, whereas the late group received such a support until development of the side effects, like 50% required oral dietary intake or > 10% weight loss. The data were collected and statistically analyzed. Results: There was no significant difference in baseline clinical characteristics between these two groups, suggesting that no selection bias occurred. Both groups of patients had weight loss at the end of CRT and 3 months thereafter. However, at the later time point, the early group started to regain their weight, while the late group continued to lose weight. At both time points, the early group had a lower percentage of weight loss than the late group. Similar results were also obtained for BMI, albumin, and pre-albumin levels (All p< 0.05). Besides, the early group showed a lower rate of advanced mucositis, a lower percentage of patients with more than 3 days RT breaks, fewer days of RT delayed for toxicity, and a lower percentage of patients with unplanned hospitalizations (All p< 0.05). A linear correlation was also found between the percentage of weight loss and the number of days of RT delayed. Conclusions: Early nutritional intervention provides beneficial outcomes to NPC patients by maintaining their nutritional status and enhancing CRT treatment tolerance. Our results also indicated early nutrition intervention may reduce the hospital cost and improve patients’ life quality.

MON-LB077 A Large Single Institution Series of Neuroendocrine Recovery and Tumor Recurrence after Pituitary Apoplexy

Introduction: Pituitary apoplexy (PA) is a neurosurgical and endocrine emergency. Prompt recognition and treatment can significantly improve outcomes. Although there are several case series and retrospective reviews of patients with pituitary apoplexy, the vast majority of these include less than 50 patients. Furthermore, endocrine follow-up data is lacking from these studies. We aimed to retrospectively review recovery of neuroendocrine function in early vs. late surgery and to determine whether there was a lower incidence of recurrence of pituitary tumors after apoplexy. Methods: We reviewed the charts of 72 patients managed surgically for PA at our hospital between 1986 and 2018. We analyzed presentation patterns, imaging, and pathology findings, and pre and post-operative endocrine data. Patients were included in the study if they had surgical or pathologic confirmation of PA. There were no exclusion criteria. Early intervention was defined as within 8 days of presentation. Post-operative hormone replacement was evaluated by review of patients’ medications. Results: Of the 72 patients reviewed, data regarding early vs. late surgery was available for 69 patients. 47.8% (n=33) of patients received early intervention and 52.2% (n=36) received surgery 8 or more days after symptom onset. No association between timing of surgery and recovery of neuroendocrine function was observed. 51.5% (n=17) of patients who received early surgery vs. 52.8% (n=19) who received late surgery required post-operative steroid replacement (p= 0.92). 42.4% (n=14) vs. 40.0% (n=14) required post-operative thyroid replacement (p=0.84). 24.2% (n=8) vs. 17.1% (n=6) required post-operative testosterone replacement (p=0.47). 12.1% (n=4) vs. 8.8% (n=3) required post-operative DDAVP replacement (p=0.71). 17% (n=12) of our patients had tumors that recurred. Of these, 8 were non-functioning adenomas, 2 were Rathke cleft cysts, 1 was a prolactinoma, and 1 was a chordoma. 4 of our patients were lost to follow up. Neurological outcomes resolved in 45% (n=15) vs. 50% (n=18) of patients, and improved in 45% (n=15) vs. 33% (n=12) in the early vs late intervention group respectively. Conclusion: Whether to perform early surgery in patients with PA is a topic of debate. We report no significant difference in neuroendocrine outcomes of patients who were treated with early vs. late surgery. Our recurrence incidence after PA is consistent with that of non-functioning pituitary adenomas that do not undergo apoplexy, which is quoted to be about 16%. Future studies are needed to corroborate our findings. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. s presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.

Effect of non-surgical periodontal therapy on insulin resistance and insulin sensitivity among individuals with borderline diabetes: A randomized controlled trial

ObjectiveTo investigate the effect of non-surgical periodontal therapy on insulin resistance and sensitivity among individuals with borderline diabetes not receiving medications. MethodsA crossover, randomized controlled trial was conducted among participants with borderline diabetes diagnosed by a 75-g oral glucose tolerance test. Participants were randomly assigned to either an early or later intervention group. The early intervention group underwent non-surgical periodontal therapy of scaling and root planing during the first 6 months, followed by a 6-month non-intervention period. The order was reversed in the later intervention group. Primary outcomes included: fasting or post-load serum glucose and insulin, body mass index (BMI), HOMA-IR, HOMA-β, and Matsuda Index. ResultsSeventy-four participants were randomized, and 71 participants completed the trial. There were no significant differences between groups in glucose and insulin concentrations during the intervention and non-intervention periods. When analyzed within groups by median-split of bleeding on probing (BOP) levels before intervention, the lower BOP group showed improved changes in BMI, HOMA-IR, HOMA-β, and Matsuda Index (P < 0.05). Further, we observed a positive correlation between baseline BOP and change in BMI (P = 0.06). Change in BMI was positively correlated with changes in HbA1c, HOMA-IR, and HOMA-β (P < 0.05), and inversely correlated with change in Matsuda Index (P = 0.001). ConclusionsPeriodontal therapy had no significant effect on markers related to insulin and glucose metabolism among individuals with borderline diabetes. However, participants with a lower BOP (%) showed significant improvements in BMI, fasting serum insulin, HOMA-IR, HOMA-β and Matsuda Index. Clinical significanceAmong individuals diagnosed with borderline diabetes, those who had <37% of a lower BOP (%) showed potential improvements in BMI, fasting serum insulin, HOMA-IR, HOMA-β and Matsuda Index following non-surgical periodontal therapy.

The role of the family in early intervention of preterm infants with abnormal general movements.

Objectives:To determine the effect of family-based intervention on motor function in preterm infants.Methods:This study was designed as a randomized controlled trial between August 2015 and September 2016. Forty-two preterm infants were randomized and split equally between the family-based intervention group, composed of a physiotherapeutic and a familial component (8 males, 8 females; mean age 91±3.09 days), and the traditional early intervention group (8 females, 8 males, mean age: 91.06±2.4 days). Both groups received a treatment program based on a neurodevelopmental approach during 3- to 12-months-old. The groups were evaluated at corrected ages of the third, sixth, ninth, twelfth, and 24th months using the Bayley Scale of Infant and Toddler Development, Third Edition (Bayley-III).Results:Within-group changes over time were statistically significant using multivariate tests of fine motor (Multivariate analysis of variance (MANOVA); F=1515.27, p<0.001) and gross motor (MANOVA; F=1950.59, p=0.001) development. However, there was no interaction between groups in fine (MANOVA; F=0.027, p=0.872) and gross motor development (MANOVA; F=0.022, p=0.883).Conclusion:The early intervention approaches might support fine and gross motor function development in preterm infants in the first year of life.

Outcome of Early vs. Delayed Invasive Intervention in Acute Coronary Syndrome Patients Attending a Selected Specialized Hospital: A Comparative Study

Background: This study was to compare the outcome of early versus delayed invasive intervention in acute coronary syndrome (ACS) patients.&#x0D; Methods: A total of 200 patients with ACS underwent early intervention group (d”24 h, n=100) and delayed intervention group (&gt;24 to 72 h, n=100) after percutaneous coronary intervention (PCI) were enrolled. The probable outcomes were a composite of re-infarction, acute LVF, recurrent ischemia, repeat revascularization, bleeding, stroke or death at 30 days.&#x0D; Results: Male were predominating (74%vs26%). Left anterior descending artery was the commonest infarct related artery in both groups (p=0.114). Cardiac markers, Cardiogenic shock, Acute left ventricular failure (LVF) and ventilator requirement were significantly higher (p=0.007, p=0.060, p=0.009, p=0.002) and mean duration of hospital stay was longer (p &lt;0.001) in delayed intervention group. At 30 days follow-up improvement of chest pain, LVF and ejection fraction were achieved significantly in patient undergoing early intervention (p &lt;0.001, p=0.016, 54.7±7.4 vs. 48.4±6.9; p &lt;0.001). Adverse outcome like acute LVF (7% vs. 21%; p=0.004), re-infarction (0% vs. 7%; p=0.007), acute kidney injury (AKI) (5% vs. 17%; p=0.007), bleeding (11% vs. 18%; p=0.160), stroke (3% vs. 9%; p=0.074), repeat revascularization (1% vs. 7%; p=0.032), death (0% vs. 5%; p=0.030) was higher in delayed invasive intervention group (p=0.001).&#x0D; Conclusion: Acute LVF, ventilator requirement and duration of hospital stay were significantly predominating in delayed intervention group. Early invasive strategy in ACS patient associated with lower rates of acute LVF, acute kidney injury, re-infarction, stroke, bleeding, repeat revascularization and death compared with delayed invasive strategy at 30 days of follow-up.&#x0D; Cardiovasc. j. 2019; 11(2): 129-138

Medical Management of Children With Congenital/Infantile Cataract Associated With Microphthalmia, Microcornea, or Persistent Fetal Vasculature.

To report the surgical outcomes of children with cataract associated with microphthalmia, microcornea, or persistent fetal vasculature (MMP) and children with isolated cataract. The study included 111 children (cataract associated with MMP: n = 25) who underwent cataract surgery at younger than 16 years. Exclusion criteria were duration of follow-up less than 5 years, intraindividual differences in age at surgery, eye disorders other than MMP, secondary cataract, and syndromal diseases. Main outcome measures were proportion of eyes with glaucoma and best corrected visual acuity (BCVA). Both groups were dichotomized by age at surgery (early intervention group: ≤ 48 days). Descriptive analysis was performed throughout. Median age at surgery was 3.9 months for cataract associated with MMP and 23.3 months for isolated cataract. The median (interquartile range [IQR]) duration of follow-up was 95.9 months (range: 76.0 to 154.5 months). In children with bilateral cataract associated with MMP, the proportion of eyes with final BCVA worse than 0.3 logMAR was similar regardless of age at surgery (early intervention: 80%, later intervention: 78%). In bilateral isolated cataract, the proportions were 56% and 33%, respectively. Children with cataract associated with MMP had a high prevalence of glaucoma (28%). Glaucoma prevalence was lower in the later intervention group. In the presence of MMP, early cataract surgery is associated with a high risk of post-lensectomy glaucoma, but does not offer the benefit of better visual outcomes. [J Pediatr Ophthalmol Strabismus. 2019;56(1):43-49.].

Association between vitamin B group supplementation with changes in % flow-mediated dilatation and plasma homocysteine levels: a randomized controlled trial.

There is limited evidence examining the association between B vitamin supplementation and improved endothelial function via lowering plasma homocysteine levels. This study investigated whether low-dose B vitamin supplementation improves endothelial dysfunction in Japanese adults with one or more components of metabolic syndrome. A randomized, controlled, crossover trial, without a washout period or blinding of subjects, was conducted from May-September, 2010. The subjects were 127 Japanese men and women aged 40–65 years who had at least one component of metabolic syndrome without medication. Participants took a supplement drink for two months but were divided into early intervention or later intervention groups. The flow-mediated dilatation, plasma homocysteine level, serum B-vitamins, and vitamin C levels were measured. A significant increase in serum B vitamins and vitamin C levels, and a reduction in plasma homocysteine levels were observed. The mean serum homocysteine level pre- and post-intervention was 9.8 and 8.2 µmol/L in the early intervention group and 10.8 and 7.4 µmol/L in the later intervention group (p<0.01). However, no significant changes in flow-mediated dilatation was found. Low-dose multivitamin supplementation including B vitamins is associated with a significant reduction in plasma homocysteine levels among patients with one or more components of metabolic syndrome. This study was registered at the University Hospital Medical Information Network (UMIN) centre, and has the identifier UMIN000004436.

Effect of Early Nutrition Intervention on Advanced Nasopharyngeal Carcinoma Patients Receiving Chemoradiotherapy.

Background: Patients with nasopharyngeal carcinoma (NPC) frequently developed the problem of malnutrition at the time of diagnosis. Chemoradiotherapy (CRT) can even worsen the situation. Therefore, nutritional intervention should be applied to prevent CRT-associated weight loss and interruption of CRT. However, it is still controversial if early nutritional intervention is beneficial to NPC patients with CRT. This study is to investigate the influence of early nutritional intervention on advanced NPC patients with CRT by evaluating the nutritional status and CRT treatment tolerance.Methods: A cohort of 78 stage III-IV nasopharyngeal carcinoma patients was divided into early (n=46) and late (n=32) nutrition intervention groups. The early group of patients received nutritional support at the beginning of CRT, whereas the late group received such a support until development of the side effects, like 50% required oral dietary intake or >10% weight loss. The data were collected and statistically analyzed.Results: There was no significant difference in baseline clinical characteristics between these two groups, suggesting that no selection bias occurred. Both groups of patients had weight loss at the end of CRT and 3 months thereafter. However, at the later time point, the early group started to regain their weight, while the late group continued to lose weight. At both time points, the early group had a lower percentage of weight loss than the late group. Similar results were also obtained for BMI, albumin, and pre-albumin levels (All p<0.05). Besides, the early group showed a lower rate of advanced mucositis, a lower percentage of patients with more than 3 days RT breaks, fewer days of RT delayed for toxicity, and a lower percentage of patients with unplanned hospitalizations (All p<0.05). A linear correlation was also found between the percentage of weight loss and the number of days of RT delayed.Conclusion: Early nutritional intervention provides beneficial outcomes to NPC patients by maintaining their nutritional status and enhancing CRT treatment tolerance. Our results also indicated early nutrition intervention may reduce the hospital cost and improve patients' life quality.

A randomized trial of early endovenous ablation in venous ulceration: a critical appraisal: Original Article: Gohel MS, Heatly F, Liu X etal. A randomized trial of early endovenous ablation in venous ulceration. N Engl J Med 2018; 378:2105-114.

Gohel etal. aimed to compare early endovenous ablation vs. deferred endovenous ablation of superficial venous reflux with regard to time to healing of venous leg ulcers, rate of healing at 24 weeks, recurrence rate, ulcer-free time and health-related quality of life. This multicentre, parallel-group (ratio 1:1), randomized controlled trial was conducted in a vascular surgery department setting at 20 participating centres across the U.K. A total of 450 patients with venous leg ulcers were randomly assigned to receive compression therapy and undergo early endovenous ablation of superficial venous reflux within 2 weeks after randomization (early-intervention group) or to receive compression therapy alone, with consideration of endovenous ablation deferred until after the ulcer was healed or until 6 months after randomization if the ulcer was unhealed (deferred-intervention group). The primary outcome was the time to ulcer healing. Secondary outcomes were the rate of ulcer healing at 24 weeks, the rate of ulcer recurrence, the length of time free from ulcers (ulcer-free time) during the first year after randomization, and patient-reported health-related quality of life. Endovenous laser or radiofrequency ablation, ultrasound-guided foam sclerotherapy, or nonthermal, nontumescent methods of treatment (such as cyanoacrylate glue or mechanochemical ablation) were performed either alone or in combination. The treating clinical team determined the method and strategy of endovenous treatment. The time to ulcer healing was shorter in the early-intervention group than in the deferred-intervention group. Furthermore, more patients had healed ulcers with early intervention [hazard ratio for ulcer healing 1·38, 95% confidence interval (CI) 1·13-1·68; P = 0·001]. The median time to ulcer healing was 56 days (95% CI 49-66) in the early-intervention group and 82 days (95% CI 69-92) in the deferred-intervention group. The rate of ulcer healing at 24 weeks was 85·6% in the early-intervention group and 76·3% in the deferred-intervention group. The median ulcer-free time during the first year after trial enrolment was 306 days (interquartile range 240-328) in the early-intervention group and 278 days (interquartile range 175-324) in the deferred-intervention group (P = 0·002). The most common complications were pain and deep vein thrombosis (DVT) (early-intervention group: pain, six of 28; DVT, nine of 28; deferred-intervention group: pain, six of 24; DVT, three of 24). Gohel etal. conclude that early endovenous ablation of superficial venous reflux results in faster healing of venous leg ulcers than deferred endovenous ablation. Patients assigned to the early-intervention group also had longer ulcer-free time during the first year after randomization.

Clinical characteristics and surgical outcomes of internal hernia after gastrectomy in gastric cancer patients: retrospective case control study.

Although the internal hernia is rare after gastric cancer surgery, it is a serious complication, and prompt surgical treatment is essential. However, internal hernia has not been studied because of low incidence and difficulty of diagnosis. This study investigated the clinical characteristics and proper management of internal hernia after gastrectomy. From June 2001 to June 2016, patients who underwent gastrectomy, either open or laparoscopic (robotic) surgery, with potential internal hernia defect were enrolled. The hernia defect was not closed in any of the enrolled patients. The clinicopathological data of internal hernia patients were compared to patients without internal hernia to identify risk factors. Surgical outcomes of internal hernia were compared between patients who underwent early and late intervention group according to time interval from symptom onset to operation. Of 5777 patients who underwent gastrectomy with possible internal hernia, 24 (0.4%) underwent emergency or scheduled surgery for internal hernia. Internal hernia through the Petersen space was observed in 15 cases, and through the jejunojejunostomy mesenteric defect in 9 cases. Low body mass index (odds ratio [OR] 4.403, p = 0.003) and laparoscopic approach (OR 6.930 p < 0.001) were statistically significant factors in multivariate analysis. Postoperative complication rate (16.7% vs. 50% p = 0.083) and mortality rate (8.3% vs. 25.0% p = 0.273) were slightly higher in the late intervention group. Although internal hernia is a rare complication, it is difficult to diagnose and cause serious complications. To prevent internal hernia, the necessity of hernia defect closure should be investigated in the further studies. Early surgical treatment is necessary when it is suspected.

A multi-component wellbeing programme for upper secondary students: Effects on wellbeing, buoyancy, and adaptability

School-related wellbeing, academic buoyancy, and adaptability are valued constructs in their own right, as indicators of student welfare and as predictors of academic achievement. In the present study, we examined the impact of a six-session multi-component, intervention on school-related wellbeing, academic buoyancy, and adaptability. Participants in their first year of upper secondary education were randomly allocated to early intervention groups, or wait list-control groups. Following baseline measurements, outcomes were assessed after the early intervention groups and again after the wait list-control groups. Following intervention, a slowed decline was shown in school-related wellbeing and adaptability was boosted. Buoyancy was boosted in the early intervention group but not the late intervention group. Findings show how a relatively short intervention can beneficially impact on student outcomes. Booster sessions may be required to maintain the benefits for wellbeing and adaptability.

The recovery of post-burn hypertrophic scar in a monitored pressure therapy intervention programme and the timing of intervention

IntroductionPressure therapy used to be considered as the mainstay non-invasive treatment of hypertrophic scar. However, the maturation process of hypertrophic scar during pressure therapy process has seldom be reported. Moreover, although early application of pressure therapy after burn injuries is reco6mmended, minimal evidence exists to support it. This study aimed to examine the maturation trajectory of post-burn hypertrophic scars in a 6-month monitored pressure therapy intervention programme and investigate the difference in the trajectory between patients receiving early intervention and patients receiving late intervention. MethodsThirty-four patients with sixty-five post-burn hypertrophic scar samples were recruited for the study. All the subjects were treated with a 6-month pressure therapy programme with the pressure dosage regulated using a newly developed pressure therapy system, the Smart Pressure Monitored Suits. The selected scars were assessed with MiniScan XE Spectrocolorimeter on scar pigmentation, and Terason t3000 portable ultrasound imaging equipment on scar thickness. The Vancouver Scar Scale (VSS) was used to evaluate pigmentation, pliability, vascularity and height of the scars. Subjects’ report of pain and itch was documented. Assessments were conducted before treatment began and then monthly during the 6 month-intervention process. Patients were further divided into two groups according to the time of intervention post-burn injuries to review differences in the maturation trajectory between those who received early versus late treatment (early intervention group, prescribed within 60days after injuries; late intervention group, prescribed after 61 days). The changes of scar features were recorded to formulate the recovery trajectory of scar, and the outcomes of intervention between the early and the late groups were compared. ResultsPre- and post-treatment comparison demonstrated significant improvement in scar pigmentation, thickness, VSS scores and scores of pain and itch (p<0.01) for the early intervention group. For the later intervention, only scar lightness, yellowness, VSS scores and scores of pain and itch was found with significant improvement (p<0.01). The improvement in these scar characteristics was sustained over time during the treatment process. The early group demonstrated superior effect in improving scar lightness, yellowness (p<0.01), thickness (p<0.01), pigmentation score (p<0.05) and pain score (p<0.01) than the late group in comparison between the two groups at similar post-burn timing. ConclusionsHypertrophic scars appeared to undergo continuous improvement in the appearance, pain and itch over time during the process of a monitored pressure intervention programme. Early application of pressure therapy after burn injury may contribute to better outcomes as shown by their faster recovery than those with late intervention. In order to achieve the best outcomes, regular evaluation and adjustment for optimal interface pressure is necessary.

Benefits of Early Surgery on Clinical Outcomes After Degenerative Mitral Valve Repair

This study aimed to evaluate the clinical trends of mitral valve repair for degenerative mitral regurgitation and the benefit of early surgical intervention on repair durability in a high-volume center. From January 2003 to December 2015, 1,903 consecutive patients with severe degenerative mitral regurgitation underwent mitral valve repair at our institution. The timing of surgical intervention was evaluated by guideline-related indications including symptoms, atrial fibrillation, left ventricular dysfunction, and pulmonary hypertension. Clinical outcomes and risk factors for recurrent mitral regurgitation were analyzed. Over 13 years from 2003 to 2015, trends of preoperative characteristics demonstrated that the proportion of asymptomatic patients substantially increased. The 8-year overall survival, freedom from reoperation for mitral valve, and freedom from recurrent mitral regurgitation were 96%, 96%, and 85%, respectively. Ejection fraction less than 60%, left ventricular end-diastolic dimension greater than 60 mm, isolated anterior leaflet lesion, and intraoperative mild residual mitral regurgitation were independent predictive factors for recurrent mitral regurgitation. The incidence of recurrent mitral regurgitation was significantly lower in the early intervention group (3% versus 18%, p < 0.01). In subgroup analysis of asymptomatic patients, the incidence of recurrent mitral regurgitation was significantly lower in patients without guideline-related indications (3% versus 31%, p < 0.0001). Early surgical intervention for severe degenerative mitral regurgitation before symptoms, atrial fibrillation, and ventricular dysfunction are associated with excellent clinical outcomes. Besides complexity of leaflet lesion and repair quality, surgical timing also significantly affects repair durability. Early surgical intervention should therefore be recommended to reduce recurrent mitral regurgitation.

Is reducing uncertain control the key to successful test anxiety intervention for secondary school students? Findings from a randomized control trial.

The aim of the study was to conduct a randomized control trial of a targeted, facilitated, test anxiety intervention for a group of adolescent students, and to examine the mediating role of uncertain control. Fifty-six participants (male = 19, white = 21, mean age = 14.7 years) were randomly allocated to an early intervention or wait-list control group. Participants completed the Revised Test Anxiety Scale and the Uncertain Control Scale from the Motivation and Engagement Scale at baseline, after the early intervention group had received the intervention, and again, after the wait-list control group had received the intervention. Participants showed moderate to large reductions in the worry and tension components of test anxiety, and uncertain control, after the intervention. The reduction in worry and tension was partially mediated by the reduction in uncertain control. Findings contribute to the evidence base for test anxiety interventions designed for school age populations and highlight uncertain control as an important factor in test anxiety intervention. (PsycINFO Database Record

A Randomized Trial of Early Endovenous Ablation in Venous Ulceration

BackgroundVenous disease is the most common cause of leg ulceration. Although compression therapy improves venous ulcer healing, it does not treat the underlying causes of venous hypertension. Treatment of superficial venous reflux has been shown to reduce the rate of ulcer recurrence, but the effect of early endovenous ablation of superficial venous reflux on ulcer healing remains unclear.MethodsIn a trial conducted at 20 centers in the United Kingdom, we randomly assigned 450 patients with venous leg ulcers to receive compression therapy and undergo early endovenous ablation of superficial venous reflux within 2 weeks after randomization (early-intervention group) or to receive compression therapy alone, with consideration of endovenous ablation deferred until after the ulcer was healed or until 6 months after randomization if the ulcer was unhealed (deferred-intervention group). The primary outcome was the time to ulcer healing. Secondary outcomes were the rate of ulcer healing at 24 weeks, the rate of ulcer recurrence, the length of time free from ulcers (ulcer-free time) during the first year after randomization, and patient-reported health-related quality of life.ResultsPatient and clinical characteristics at baseline were similar in the two treatment groups. The time to ulcer healing was shorter in the early-intervention group than in the deferred-intervention group; more patients had healed ulcers with early intervention (hazard ratio for ulcer healing, 1.38; 95% confidence interval [CI], 1.13 to 1.68; P=0.001). The median time to ulcer healing was 56 days (95% CI, 49 to 66) in the early-intervention group and 82 days (95% CI, 69 to 92) in the deferred-intervention group. The rate of ulcer healing at 24 weeks was 85.6% in the early-intervention group and 76.3% in the deferred-intervention group. The median ulcer-free time during the first year after trial enrollment was 306 days (interquartile range, 240 to 328) in the early-intervention group and 278 days (interquartile range, 175 to 324) in the deferred-intervention group (P=0.002). The most common procedural complications of endovenous ablation were pain and deep-vein thrombosis.ConclusionsEarly endovenous ablation of superficial venous reflux resulted in faster healing of venous leg ulcers and more time free from ulcers than deferred endovenous ablation. (Funded by the National Institute for Health Research Health Technology Assessment Program; EVRA Current Controlled Trials number, ISRCTN02335796.)

Can the Amount of Interventions during the Convalescent Phase Predict the Achievement of Independence in Activities of Daily Living in Patients with Stroke? A Retrospective Cohort Study

This study aimed to evaluate the diagnostic performance of the amount of physical, occupational, and speech therapy intervention and optimal timing necessary for activities of daily living (ADL) independence in patients with stroke. Patients (N = 441) with stroke admitted to the convalescent rehabilitation ward were classified into an early intervention or a nonearly intervention group on the basis of the duration from the date of onset to date of hospital admission. Logistic regression model was used to identify factors influencing independence in ADL in both groups. Cutoff point, likelihood ratio, and posterior probabilities for ADL independence were calculated, and diagnostic accuracy was evaluated for extracted factors. Results of logistic regression analysis revealed that age and physical and occupational therapy intervention amount provided during convalescent phase and Functional Independent Measure (FIM) motor score at admission significantly influenced independence in ADL at discharge from the hospital in the early intervention group (hospitalization date was 30 days or less). The cutoff point was 168 hours; positive likelihood ratio was 1.74; negative likelihood ratio was .78; and the posterior probability for the time spent by the therapist was 81.0%. FIM motor score at admission was the only factor extracted for the nonearly intervention group (hospitalization date was 31 days or more). The ADL independence in patients with stroke admitted to convalescent rehabilitation ward during their convalescent phase cannot be determined simply on the basis of the amount of physical and occupational therapy they receive.

Effects of early intervention on feeding behavior in preterm infants: A randomized controlled trial

BackgroundAlthough highly beneficial, human milk feeding is challenging in preterm infants due to adverse NICU factors for the infant and mother. AimTo investigate the effects of an early intervention in promoting infant's human milk feeding and acquisition of full oral feeding. MethodsThis study is part of a RCT. We included preterm infants born between 25+0 and 29+6 weeks of gestational age (GA) without severe morbidities, and their parents. Infants were randomized to either receive early intervention (EI) or standard care (SC). EI included PremieStart and parental training to promote infant massage and visual attention according to a detailed protocol. SC, in line with NICU protocols, included Kangaroo Mother Care. The time of acquisition of full oral feeding and human milk consumption at discharge were recorded. ResultsSeventy preterm (EI n = 34, SC n = 36) infants were enrolled. Thirteen were excluded according to the protocol. Fifty-seven (EI n = 29, SC n = 28) infants were evaluated at discharge. The two groups were comparable for parent and infant characteristics. A significantly higher rate of infants fed with any human milk was observed in the EI group (75.9%) compared with the SC group (32.1%) (p = 0.001), and EI infants were four times more likely to be fed exclusively with human milk. Full oral feeding was achieved almost one week earlier in EI infants (mean postmenstrual age 36.8 ± 1.6 vs 37.9 ± 2.4 weeks in EI vs SC, p = 0.04). ConclusionsEarly interventions promoting mother self-efficacy and involvement in multisensory stimulation have beneficial effects on human milk feeding in preterm infants.

Post-cholecystectomy bile duct injuries: when to repair?

Background: Post cholecystectomy bile duct injury (BDI) though rarely happens; it has its own impact on postoperative outcomes. There is controversy on the optimal time for repair of such injuries. The aim of this study was to analyze the different time modalities used for repair of these injuries and its outcomes.Methods: This was a prospective randomized study conducted at General Surgery Department, Sohag university hospital, from August 2013 to March 2017. It included forty patients diagnosed to have BDI after cholecystectomy divided into 3 groups according to the time of intervention; early, intermediate, and late. We compared them regarding the pre-operative, operative variables and analyzed the post-operative outcomes among groups with one year follow-up after repair. Results: Bile leakage was the main presenting symptom in 100% of patients of early intervention group while there was combination of jaundice (71.43%) and bile leakage (28.57%) in the other two groups, 28.57% of patients of intermediate intervention required ICU admission. In the early intervention group there were tendency towards less severe injuries requiring simpler maneuvers for repair with primary repairs or end to end anastomoses while in late intervention group there were tendency towards more severe injuries requiring more complex maneuvers for reconstruction. In the post-operative course there was a tendency for intermediate intervention group to have higher incidence of complications in the early and late post-operative course (57%, p=0.007). Add to this the intermediate intervention group had the longest hospital stay (p=0.008) and was plagued by mortality rate of 21% (p=0.049).Conclusions: Late repair is superior to other time modalities of intervention in post-cholecystectomy BDI in terms of postoperative outcomes.

A multicomponent behavioral intervention for smoking cessation during pregnancy: a nonconcurrent multiple-baseline design.

Given serious consequences of maternal smoking, we aimed to develop and test a multicomponent behavioral intervention to enhance smoking cessation during pregnancy. In this nonconcurrent, multiple-baseline intervention pilot study, 48 daily smoking pregnant women (mean 13.7 weeks of gestation) were recruited from Buffalo, NY, USA. Upon completion of the repeated baseline smoking monitoring (up to 3 weeks), 30 continuous smokers received a contingent financial incentive-based intervention with three additional components (education and counseling, monitoring and feedback, and family support). After the quit date, participants met with counselors (~1 hr/visit) daily for 2 weeks and twice a week for another 6 weeks. Twenty-one out of 30 participants quit smoking completely (verified by urine cotinine) after receiving the intervention, and the other nine nonquitters decreased smoking substantially. The estimated smoking cessation rate was 70.0% (21/30) at the second week of the intervention, and 63.3% (19/30) at the conclusion of the 8-week intervention assuming the dropouts as smoking. In interrupted time series analysis, the mean daily number of cigarettes smoked among quitters decreased by 6.52, 5.34, and 4.67 among early, delayed, and late intervention groups, respectively. Quitters' mean urine cotinine level maintained stably high before the intervention but decreased rapidly to the nonsmoking range once the intervention was initiated. Most participants (85.7%) reported meeting or exceeding expectations, and 100% would recommend the program to others. This pilot multicomponent intervention was feasible and acceptable to most participants, resulting in a high smoking cessation rate among pregnant smokers who were unlikely to quit spontaneously.