Significant Mean Improvement Research Articles

Efficacy of the Intravitreal Sustained-Release Dexamethasone Implant for Diabetic Macular Edema Refractory to Anti-Vascular Endothelial Growth Factor Therapy: Meta-Analysis and Clinical Implications

To assess the effect on best-corrected visual acuity (BCVA) and efficacy of the intravitreal sustained-release 0.7 mg dexamethasone implant (Ozurdex; Allergan, Irvine, CA) in patients with recalcitrant diabetic macular edema (DME). Meta-analysis utilizing the MOOSE framework and a random effects model. Studies included adults undergoing treatment with Ozurdex for DME. The methodologic quality of each study was assessed using the MINORS and the Cochrane Collaboration Risk of Bias for randomized studies. A total of 3,859 patients among 15 studies were included in the final analysis. The mean difference in BCVA was a gain of four lines or 20 Early Treatment of Diabetic Retinopathy Study letters with Ozurdex at a mean follow-up period of 6 months. Treatment with Ozurdex is associated with significant mean improvement in visual acuity. Clinicians should have a multimodality approach to treating DME and be aware of this treatment option in those who have a suboptimal response to anti-VEGF therapy. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:160-166.].

Topical Oxybutynin 10% Gel for the Treatment of Primary Focal Hyperhidrosis: A Randomized Double-blind Placebo-controlled Split Area Study.

Limited efficacy, costs, side-effects and complications are issues of concern for most current therapeutic modalities for focal hyperhidrosis. This study evaluated the efficacy of topical oxybutynin 10% gel in treating 61 patients with primary focal hyperhidrosis. The gel was applied to the right or left axilla, palms or soles vs. a placebo compound to the contralateral side for 30 days. A blinded visual grading of the change in starch-iodine tests was performed by 2 non-involved physicians. The Hyperhidrosis Disease Severity Scale (HDSS) and Dermatology Life Quality Index (DLQI) questionnaires were administered before and after treatment. The patients rated their satisfaction with treatment. Fifty-three patients completed the 4-week treatment. Sweat reduction in the drug-treated sweating areas was higher than in the control-treated areas. There was a significant mean improvement in pre- and post-treatment HDSS and DQLI (p = 0.001 for both). Thirty-nine subjects (74%) reported moderate-to-high satisfaction. Twice-daily topical application of oxybutynin 10% gel appears to be an effective, safe and well-tolerated treatment for focal primary hyperhidrosis.

Patient Subgroup Analysis of Quality-of-Life Outcomes in Checkmate 205, a Phase 2 Study of Nivolumab in Patients with Classical Hodgkin Lymphoma

Introduction: Nivolumab is a fully human IgG4 immune checkpoint inhibitor targeting programmed death receptor-1 (PD-1). It has recently been approved by the FDA in the US for patients with classical Hodgkin lymphoma (cHL) who have failed autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplant brentuximab vedotin (cohort B of CheckMate 205). The objective response rates in cohort B of CheckMate 205 (NCT02181738) per independent radiologic review committee (IRRC) assessment was 66%, with median time to response of 2.1 months. Furthermore, mean EuroQol Five Dimensions (EQ-5D) visual analog scale (VAS) score increased over time during treatment with nivolumab, and European Organisation for Research and Treatment of Cancer Core Quality-of-Life questionnaire (EORTC QLQ-C30) data suggested an improvement from baseline (BL) across functional, symptom, and global health scores [Younes et al. Lancet Oncol 2016; Jul 20 (Epub ahead of print)]. The aim of the current analysis is to understand if quality-of-life (QoL) changes observed in the cohort of patients with cHL vary across patient subgroups.Methods: CheckMate 205 is a multi-cohort study evaluating the efficacy and safety of nivolumab 3 mg/kg by IV infusion every 2 wks in 3 cohorts of patients with cHL post-auto-HSCT. Patient-reportedgeneral health status was assessed using the 3-level version of the EQ-5D questionnaire, and cancer-specific QoL using the EORTC QLQ-C30. Questionnaires were administered to patients every 4 cycles (every 8 wks). All treated patients with BL and at least 1 post-BL assessment in cohort B were included in this analysis population. Scores were examined across prespecified patient subgroups, including age, sex, Eastern Cooperative Oncology Group (ECOG) performance status (PS) at BL, smoking status, B symptoms at BL, region (USA/Canada or Europe), and best overall response (BOR) per investigator assessment or IRRC at wks 9, 17, 25, and 33. Least squares (LS) means were used to describe post-BL score changes over time for the overall analysis population and subgroups. Minimally important differences were prespecified.Results: 72 patients (90%) from CheckMate 205, cohort B, completed BL and at least 1 post-BL EORTC QLQ-C30 or EQ-5D assessment. By wk 33, 58% of patients were included. The mean (SD) age was 38.9 (13.3) years. 34.7% of patients were female, 45.8% had BL ECOG PS 1, and 68.1% had stage IV disease at study entry. LS mean (standard error) score change from BL at wk 33 was 19.1 (3.1) for EQ-5D VAS and 7.6 (2.3) for the EORTC QLQ-C30 global health/QoL status scale. For the global health status subscale, all subgroup estimates were consistent with the overall changes from BL, except patients with absence of B symptoms who experienced significantly smaller changes at wk 17 only. For other EORTC subscales where statistically significant improvements in LS mean from BL were observed at each time point (fatigue, dyspnea, appetite loss, physical functioning, role functioning), although all subgroup estimates were in line with the overall change, there were some trends for non-smokers (vs smokers), ECOG PS 0 (vs 1), USA/Canada (vs Europe), and B symptoms at BL (vs none) toward better symptom improvement. Changes from BL across responders and non-responders were consistent with overall changes from BL.Conclusions: In this small cohort of patients with cHLwho had failed auto-HSCT and subsequent brentuximab vedotin, the improvement in QoL observed while on-treatment with nivolumab was mostly consistent across the subgroups investigated.Funding: Bristol-Myers Squibb (BMS). Medical writing: S Addison, Caudex, funded by BMS. DisclosuresEngert:Takeda, BMS: Consultancy, Honoraria, Research Funding. Taylor:Bristol-Myers Squibb: Consultancy. Bennett:Bristol-Myers Squibb: Consultancy. Hirji:Bristol-Myers Squibb: Employment. Cocks:Bristol-Myers Squibb: Consultancy. McDonald:Bristol-Myers Squibb: Consultancy. Mann:Bristol-Myers Squibb: Consultancy. Kato:Bristol-Myers Squibb: Employment. Cella:Alexion, Inc., Astellas, Biogen Idec, Celgene, Clovis Oncology, Inc., Daiichi Sankyo, Eli Lilly, Evidera, Inc., Exelixis, Fiborgen, Genetech, Helsinn Therapeutics, Inc., Immunogen, Ipsen Pharma, Janssen, Lexicon Pharmaceuticals, Inc., Merck, Novartis, Onc: Consultancy, Research Funding; Bristol-Meyers Squibb: Consultancy, Research Funding; Abbvie, Inc.: Consultancy, Research Funding; GlaxoSmithKline: Consultancy, Research Funding; Bayer Pharmaceuticals, Inc.: Consultancy, Research Funding; Facit.org: Other: President.

Robot-Assisted Laparoscopic Simple Prostatectomy with Retropubic Approach in Benign Prostatic Hyperplasia: Single Center Experience and Video Demonstration

Introduction: Robot-assisted laparoscopic simple prostatectomy was first reported in 20081 and minimally invasive simple prostatectomy demonstrated to be feasible in men with prostate size >80 cc needing surgical treatment under EAU guidelines.2 From 2006 to 2016, more than 1000 robotic surgeries were carried out in our medical center.3 In this study, we will introduce our single medical center experience of robot-assisted laparoscopic simple prostatectomy. Materials and Methods: A total of 30 patients who underwent robot-assisted laparoscopic simple prostatectomy were included in the study. All of them had symptomatic benign prostatic obstruction with prostate volume >80 cc. Transrectal biopsy was also performed in all of the patients and reveal nodular hyperplasia without evidence of malignancy. Preoperative assessments include PSA, International Prostate Symptom Score (IPSS), uroflowmetry, and postvoid residual urine. Operation was performed with a four-arm da Vinci surgical system with six ports that adapted the transperitoneal approach.4 Bladder was mobilized and Retzius' space was reached. Two rows of hemostatic sutures for control of the Santorini plexus were used. Dissection of the adenoma from the prostatic capsule was performed by the Millin's retropubic method.5 The bladder neck mucosa was approximated to the prostate apex to achieve retrigonization and anterior prostatic capsule was closed. Foley's tube was inserted and kept for about 7 to 14 days. In our clinical experience, cystogram was not performed routinely and it may be used in case for evaluation of anastomosis leakage. Parameters such as bladder neck-to-pubic symphysis ratio6 or posterior vesicourethral angle7 would be used as predictor for postoperative continence. Results: Totally 30 patients underwent the whole procedure without major complication. Mean patient age was 65.7 (55–79) years and mean estimated prostate volume was about 105.43 cc (75.0–173.0 cc). Mean operation time measured was 140 minutes (105–190) and mean blood loss was estimated about 141.3 mL (30–850). Patient stay was about 4.5 days and mean catheterization days were about 8.83 days. There was significant improvement in postoperative outcome based on uroflowmetry and International Prostate Symptoms Score. For uroflowmetry, there was also significant improvement in mean and maximum flow rate, which increased from 3.25 to 10.54 mL/s (p < 0.001) and from 8.36 to 21.25 mL/s (p < 0.001), respectively. Postvoiding residual urine volume also showed significant decrease from 98.36 to 11.00 mL (p < 0.001). Concerning patient's self-administered parameter, International Prostate Symptoms Score also showed significant improvement from 23.47 to 3.47. The patient was 69 years old and healthy with benign prostatic obstruction, and prostate measured about 85 g. We performed retropubic simple prostatectomy by the transperitoneal approach as already mentioned. Direct anastomosis was performed at bladder neck and urethra without trigonization. Cystography was performed at the seventh day after operation and showed the bladder neck in good shape. Good continence was also noted immediately after the catheter was removed and the patient was voiding well during follow-up. Conclusion: Robotic simple prostatectomy may be a feasible alternative option for patients with benign prostate hyperplasia and greatly enlarged prostate gland in consideration of acceptable complications and postoperative continence. Human Ethical Statement: Certification of approval with IRB: CE15215B. Music Origination: Bumper-Tag, edit by John Delay, download from YouTube Audio Library. No competing financial interests exist. Runtime of video: 7 mins 56 secs

Clinical outcomes of combined versus separate carbachol and brimonidine drops in correcting presbyopia.

BackgroundTo test and compare in a masked fashion the efficacy of using a parasympathomimetic drug (3% carbachol) and an alpha-2 agonist (0.2% brimonidine) in both combined and separate forms to create optically beneficial miosis to pharmacologically improve vision in presbyopia.MethodsA prospective, double-masked, randomized, controlled clinical trial was conducted. Ten naturally emmetropic and presbyopic subjects between 42 and 58 years old with uncorrected distance visual acuity of at least 20/20 in both eyes without additional ocular pathology were eligible for inclusion. All subjects received 3% carbachol and 0.2% brimonidine in both combined and separate forms, 3% carbachol alone and 0.2% brimonidine (control) alone in their non-dominant eye in a crossover manner with one week washout between tests. The subjects’ pupil sizes and both near and distance visual acuities will be evaluated pre- and post-treatment at 1, 2, 4, and 8 h, by a masked examiner at the same room illumination.ResultsStatistically significant improvement in mean near visual acuity (NVA) was achieved in all subjects who received combined 3% carbachol and 0.2% brimonidine in the same formula compared with those who received separate forms or carbachol alone or brimonidine alone (P < 0.0001).ConclusionBased on the data, the combined solution demonstrated greater efficacy than the other solutions that were tested. Improving the depth of focus by making the pupil small caused statistically significant improvement in near visual acuity, with no change in binocular distance vision.Trial registration ACTRN12616001565437. Registered 11 November 2016.

Reduced occurrence of severe visual impairment after introduction of anti-Vascular Endothelial Growth Factor in wet age-related macular degeneration - a population- and register-based study from northern Sweden.

To study the occurrence of severe visual impairment (SVI) and treatment outcome at 12months in patients treated for wet age-related macular degeneration (AMD) by use of data from the Swedish Macula Register (SMR) and referrals to the regional low vision clinics in five northern counties. Referrals to low vision clinics during 2005, 2009 and 2013 and treatment outcome at 12months from the SMR database from 2008 until 2013 in patients >65years of age in five northern counties were included in the survey. The rate of referral due to AMD was significantly reduced during the time period (-48%; p<0.001). At 12months, a significant slight mean improvement in logMAR visual acuity (VA) was observed (-0.01, SD 0.37; p<0.001) after a mean of 5.0±2.3 anti-vascular endothelial growth factor (VEGF)-injections were administered. Age and low baseline VA was associated with less favourable visual outcome (p<0.001). Referral rate to low vision clinic is a valuable tool for estimating occurrence of SVI and fell between the years 2005 until 2013. Data from the SMR showed improvement in visual acuity on the whole, but also identified patients at high risk for developing SVI during anti-VEGF-treatment.

Endoscopic Transcanal Myringoplasty for Anterior Perforations of the Tympanic Membrane

Repairing anterior perforations of the tympanic membrane has been challenging for otolaryngologists. Therefore, devising a simple and effective technique for performing the repair is crucial. To assess the results of endoscopic transcanal myringoplasty for repairing anterior perforations of the tympanic membrane. This medical record review included 59 patients who underwent endoscopic transcanal myringoplasty from January 1, 2013, to June 1, 2015, at PoJen General Hospital, Taipei, Taiwan. Patients with ossicular chain disease and cholesteatoma or inadequate follow-up were excluded. Patients were followed up for 6 months, and final follow-up was completed on January 1, 2016. The main outcome was the rate of overall graft success after endoscopic transcanal myringoplasty. Secondary outcomes included hearing results and prognostic factors. The study sample included the medical records of 59 patients (30 men [51%]; 29 women [49%]; mean [SD] age, 49.5 [13.1] years) who underwent endoscopic transcanal myringoplasty. Overall, 55 patients (93%) had a successful graft at 6 postoperative months. The mean (SD) preoperative and postoperative air-bone gaps were 15.9 (9.4) and 5.4 (7.0) dB, respectively, revealing a significant mean (SD) improvement of 10.3 (7.6) dB (Cohen d, 1.27; 95% CI, 0.90-1.63; P < .001, paired t test) in the gap. The postoperative air-bone gap in 46 patients (78%) was less than 10 dB; in 12 patients (20%), 10 to 20 dB; and in 1 patient (2%), more than 20 dB. Postoperative otorrhea significantly affected the graft success rate (odds ratio, 52.00; 95% CI, 4.08-662.55; P < .01, χ2 test). The visualization of the perforation margin (complete or partial) was not significantly associated with the graft success rate. However, partial visualization of the perforation margin significantly prolonged the mean (SD) operative time (complete vs partial, 59.2 [13.7] vs 68.1 [14.1] minutes; Cohen d, 0.64; 95% CI, 0.12-1.18; P = .02, t test). The rate of graft success and hearing outcomes for endoscopic transcanal myringoplasty are comparable with those of microscopic myringoplasty for repairing anterior perforations of the tympanic membrane. However, the present technique is simpler because postauricular incision, canalplasty, and general anesthesia are not required. Thus, endoscopic transcanal myringoplasty should be considered for repairing anterior perforations of the tympanic membrane.

Change in Health-Related Quality-of-Life at Group and Individual Levels Over Time in Patients Treated for Chronic Myofascial Neck Pain

This study evaluated change in health-related quality of life at the group and individual levels in a consecutive series of patients with chronic myofascial neck pain. Fifty patients with chronic neck pain self-administered the Short Form-36 Version 2 (SF-36 v2) before treatment and 6 weeks later. Internal consistency reliability was estimated for the 8 scale scores and Mosier's formula was used to estimate reliability of the physical and mental health composite scores. Significance of group-level change was estimated using within-group t statistics. Significance of individual change was evaluated by reliable change index. Statistically significant ( P < .05) group mean improvement over time was found for all SF-36 scores. At the individual level, 20% of the possible changes were statistically significant (17% improvement, 3% decline). Estimating the significance of individual change in health-related quality of life adds important information in comparing different treatment modalities for chronic myofascial neck pain.

Behavioral and Emotional Problems Associated With Convergence Insufficiency in Children

Objective: This study investigated behavioral and emotional characteristics of children with convergence insufficiency (CI), before and after treatment with office-based vergence accommodative therapy (OBVAT). Method: Parents of 44 children ages 9 to 17 years with symptomatic CI completed the Conners 3 ADHD Index and the Child Behavior Checklist (CBCL) before and after OBVAT. Pre-treatment scores were compared with normative data and post-treatment scores were compared with baseline using the Wilcoxon sign rank test. Results: Following OBVAT, CI children showed a significant mean improvement (p < .0001, effect size of 0.58) on the Conners 3 ADHD Index with the largest changes occurring in the 23 children who scored the highest at baseline. On the CBCL, anxious/depressed, somatic, and internalizing problems improved significantly (p < .001, effect sizes of −0.36, −1.15, and −0.67, respectively). Conclusion: In an open trial, attention and internalizing problems improved significantly following treatment for CI.

Pilot study of psychotherapeutic text messaging for depression

Background Text messaging services could increase access to psychotherapeutic content for individuals with depression by avoiding barriers to in-person psychotherapy such as cost, transportation, and therapist availability. Determining whether text messages reflecting different psychotherapeutic techniques exhibit differences in acceptability or effectiveness may help guide service development. Objectives We aimed to determine: (1) the feasibility of delivering a psychotherapy-based text messaging service to people with depression identified via the internet, (2) whether there is variation in satisfaction with messages according to the type of psychotherapeutic technique they represent, and (3) whether symptoms of depression vary according to receipt of each message type and participants’ satisfaction with the messages they received. Methods For this study 190 US adults who screened positive for a major depressive episode (Patient Health Questionnaire (PHQ-9) score ≥10) were recruited from online advertisements. Participants received a daily psychotherapy-based text message 6 days per week for 12 weeks. Text messages were developed by a team of psychiatrists, psychologists, and social workers to reflect three psychotherapeutic approaches: acceptance and commitment therapy (ACT), behavioural activation, and cognitive restructuring. Each week the message type for the week was randomly assigned from one of the three types, allowing for repeats. Participants were asked daily to rate each message. On the 7th day of each week, participants completed a two-item depression screener (PHQ-2). Web-based surveys at baseline, 6, and 12 weeks were used as the primary measure of depressive symptoms (PHQ-9). Results Of the 190 participants enrolled, 85 (45%) completed the 6-week web survey and 67 (35%) completed the 12-week survey. The mean baseline PHQ-9 score was 19.4 (SD 4.2) and there was a statistically significant mean improvement in PHQ-9 scores of −2.9 (SD 6.0; p < 0.001) at 6 weeks and −4.8 (SD 6.6; p < 0.001) at 12 weeks. Mean satisfaction ratings did not vary across message types. There was generally no association between the number of weeks in which participants received a given message type and PHQ-9 scores at follow-up. However, among individuals with more severe depression at baseline (PHQ-9 ≥ 20; n = 30), the number of weeks of behavioural activation messages received was associated with less symptom improvement (ρ = 0.37; p = 0.04) at 12 weeks. Participants who gave higher satisfaction ratings to messages regardless of type had greater reductions in PHQ-9 scores at 6 weeks. Conclusions Study participants exhibited borderline clinically significant improvement in depressive symptoms at 12 weeks suggesting the effects of the intervention, if any, were small. Although there was no overall variation in changes in PHQ-9 according to users’ exposure to the three message types, effectiveness among severely depressed participants could potentially be improved by tailoring towards fewer behavioural activation messages. Controlled studies to determine effectiveness of texting interventions such as this one are indicated considering that even small effects may be cost effective given the low cost of delivering text messages.

A clinical assessment of cochlear implant recipient performance: implications for individualized map settings in specific environments.

Individual speech intelligibility was measured in quiet and noise for cochlear Implant recipients upgrading from the Freedom to the CP900 series sound processor. The postlingually deafened participants (n = 23) used either Nucleus CI24RE or CI512 cochlear implant, and currently wore a Freedom sound processor. A significant group mean improvement in speech intelligibility was found in quiet (Freiburg monosyllabic words at 50 dBSPL) and in noise (adaptive Oldenburger sentences in noise) for the two CP900 series SmartSound programs compared to the Freedom program. Further analysis was carried out on individual’s speech intelligibility outcomes in quiet and in noise. Results showed a significant improvement or decrement for some recipients when upgrading to the new programs. To further increase speech intelligibility outcomes when upgrading, an enhanced upgrade procedure is proposed that includes additional testing with different signal-processing schemes. Implications of this research are that future automated scene analysis and switching technologies could provide additional performance improvements by introducing individualized scene-dependent settings.

Take Charge of Pain: evaluating a community-targeted self-management education program for people with musculoskeletal pain.

Issue addressed Musculoskeletal conditions are highly prevalent, affecting 28% of the Australian population. Given the persistent nature of many musculoskeletal conditions self-management is recognised as an important aspect of effective disease management. However, participant recruitment and retention for formal self-management programs is a challenge. Methods Arthritis SA (Arthritis Foundation of South Australia, a non-profit community health organisation) redesigned a shorter, community-orientated self-management education program delivered by health professionals. The program utilises aspects of the Stanford model of chronic disease self-management and motivational interviewing as well as principles of adult learning to create an effective learning environment. The program aims to guide participants to learn and practise a range of pain management strategies that are known to be effective in improving quality of life. This study used a pre- and post-test (at 6 weeks) design to determine whether this program achieved benefits in self-reported health outcomes. Outcomes that were measured included pain, fatigue, health distress, self-efficacy and communication. Results A response rate of 47% (n=102) was achieved and small but statistically significant improvements in mean [s.d.] pain scores (6.1 [2.3] to 5.4 [2.4], P=0.001), health distress (2.3 [1.3] to 2.0 [1.3], P=0.002) and self-efficacy (6.2 [2.1] to 6.8 [2.2], P=0.002) were found. Conclusion Community-based participants of this shorter, focused program recorded small but significant improvements in self-reported pain, health distress and self-efficacy. For those who completed the current program, Arthritis SA is currently exploring the potential of developing a booster session to promote sustainable positive health outcomes. So what? Supporting self-management through education is recognised as important but also as a key challenge for effective management of musculoskeletal conditions. Using a pre-post evaluation design, this study demonstrated effectiveness (short-term improvements for self-reported pain, health distress and self-efficacy) for a redesigned and shortened community-targeted program focusing on musculoskeletal pain.

Efficacy of Tadalafil De-Escalation in the Treatment of Psychogenic Erectile Dysfunction

Objectives: To assess the efficacy of tadalafil de-escalation in the therapeutic effects of psychogenic erectile dysfunction (ED) during the 3 months extension phase. Methods: A total of 90 men with mild to severe psychogenic ED were randomly divided into 2 groups: tadalafil 5 mg group and tadalafil de-escalation group. Efficacy assessments included the 5-item version of International Index of Erectile Function (IIEF-5), the Sexual Encounter Profile (SEP) questionnaires, Psychological and Interpersonal Relationship Scales (PAIRS), Erection Hardness Score (EHS). Results: Compared with the baseline, tadalafil 5 mg and de-escalation groups enhanced all efficacy outcomes. Patients receiving tadalafil 5 mg and de-escalation experienced a significant mean improvement in the psychogenic erectile function domain of the IIEF-5 from the baseline (p < 0.01). The mean change from baseline was significantly higher for the tadalafil de-escalation group than for the tadalafil 5 mg group (p < 0.05). Response to SEP3, PAIRS and EHS was significantly higher in the tadalafil de-escalation group than in the tadalafil 5 mg group (p < 0.05). The severity of ED in the tadalafil de-escalation group had reduced after treatment. It was also significantly better than those in the tadalafil 5 mg group (p < 0.05). Conclusion: Tadalafil de-escalation significantly improved the erectile function among psychogenic ED patients. This implies that tadalafil de-escalation treatment for psychogenic ED is worthy of further clinical practice and research.

Efficacy of Training Interprofessional Spiritual Care Generalists.

Provision of spiritual/religious (S/R) care has been associated with improvements in patient care, patient-provider relationships, and resource utilization. Clinicians identify a lack of training in S/R care as the primary impediment. The purpose of the study was to evaluate the effectiveness of one-day, simulation-based workshops to prepare interprofessional clinicians to function as capable, confident, and ethical spiritual care generalists. Interprofessional practitioners (physicians, nurses, social workers, psychologists, child life specialists) in a quaternary care academic pediatric hospital participated in daylong Spiritual Generalist workshops utilizing professional actors to learn requisite spiritual generalist skills. Participants completed pre- and postworkshop questionnaires on the day of the workshop, and three-month follow-up self-report questionnaires that included 1-5-point Likert scale items focused on 15 spiritual generalist skills. One hundred fifteen interprofessional staff members completed pre- and postquestionnaires and three-month follow-up surveys. Analysis revealed significant mean improvement in all 15 spiritual generalist skills targeted for developing mastery within each of three broad domains: Spiritual Screen and Care Plan, Provision of Spiritual Care, and Professional Development. Although the initial degree of improvement tended to be greater immediately postworkshop, 14 of the 15 spiritual generalist skills remained significantly higher at three months compared to preworkshop. This daylong workshop of concentrated instruction, including didactics, visual slideshow, simulation of clinical scenarios, and debriefing/discussion components, was efficient and effective in training clinicians from varied disciplines to learn basic generalist-level spiritual care skills and to collaborate more effectively with chaplains, the spiritual specialists.

Improvements in psychological dysfunction after endoscopic sinus surgery for patients with chronic rhinosinusitis.

Psychological dysfunction is highly prevalent among patients with chronic rhinosinusitis (CRS). Previous study has identified various measures of anxiety and depression as predictors of quality-of-life outcomes following endoscopic sinus surgery (ESS). Psychological dysfunction scores, as measured by the 22-item Sino-Nasal Outcome Test (SNOT-22), have been found to influence treatment decision making in CRS. This study aims to further elucidate improvement in discrete psychological symptoms following ESS for CRS. Adult patients with medically recalcitrant CRS electing to undergo ESS were prospectively enrolled into a multi-institutional, observational cohort. Psychological-related symptom severity and postoperative outcomes were assessed using psychological domain items of the SNOT-22, including subgroup analysis of patients with and without comorbid depression. A total of 374 participants met inclusion criteria and were followed postoperatively for a mean ± standard deviation (SD) of 14.6 ± 5.0 months. Total mean psychological domain scores improved from 15.9 ± 8.2 to 8.5 ± 8.4 (p < 0.001). Significant relative mean improvements were reported in "waking up tired" (23%; p < 0.001), "fatigue" (25%; p < 0.001), "reduced productivity" (28%; p < 0.001), "reduced concentration" (27%; p < 0.001), " frustrated/restless/irritable" (27%; p < 0.001), "sad" (15%; p < 0.001), and "embarrassed" (8%; p < 0.001) scores. A total of 64% to 66% of participants reported improvement in "reduced productivity," "waking up tired," "fatigue," and "frustrated/restless/irritable," compared to 46% and 38% reporting improvement in "sad" and "embarrassed," respectively. Patients with CRS report significant improvement in common mental health-related symptoms following ESS. Despite these improvements, some degree of persistent postoperative psychological dysfunction was reported. Further study is necessary to determine which factors are associated with persistent psychological dysfunction after ESS in order to optimize treatment outcomes.

Return to Play After Periacetabular Osteotomy for Treatment of Acetabular Dysplasia in Adolescent and Young Adult Athletes

Background: The Bernese periacetabular osteotomy (PAO) is an effective surgical treatment option for symptomatic acetabular dysplasia. Little evidence exists regarding the results of PAO and rates of return to play (RTP) in an athletic population. Hypothesis: The majority of athletes will demonstrate improvements in functional outcome measures, such as the modified Harris Hip Score and Hip Disability and Osteoarthritis Outcome Score, and will be able to return to sports after PAO. Study Design: Case series; Level of evidence, 4. Methods: A comprehensive surgical hip database at an academic referral center was used to identify a subpopulation of athletes on whom PAO was performed. Data analyzed included preceding surgeries, reoperations, and RTP timing and features. Standard pre- and postoperative radiologic parameters and validated functional outcome measures were assessed, and a regression model assessed risk factors for prolonged time to RTP. Results: Of 245 PAOs performed over the 5-year study period, 46 were performed in 41 patients who met inclusion criteria for being an athlete (mean age, 26.2 years; range, 13-41 years; 36 females; 19% of all PAOs), representing a variety of sports. Prior surgery had been performed on 9 hips (20%). Only 1 post-PAO procedure (2%), excision of heterotopic ossification, was performed during the study period. At final follow-up (median, 3.1 years; range, 1.2-4.4 years), significant mean improvements were observed in modified Harris Hip Score (from 71 to 90; P < .001) and Hip Disability and Osteoarthritis Outcome Score (from 64 to 89; P < .001). The University of California–Los Angeles Activity Scale scores were maintained at a high level (range, 8.0-8.2; P = .28). RTP was reported in 80% of patients (37 of 46) at a median of 9 months postoperatively, with increased postoperative pain as the only independent predictor of longer time to RTP. Of these 37 athletes, 27 (73%) returned to the same level, although this was significantly less common (P = .06) in competitive athletes (11 of 19; 58%) than in recreational athletes (16 of 18; 89%). Among those who did return at the same level, 23 of 27 (85%) were able to maintain this level over time, but this was not significantly different between competitive (8 of 11; 73%) and recreational (15 of 16; 94%) athletes (P = .27). Conclusion: Most athletic patients undergoing PAO are female patients and show postoperative improvements in function and return to athletic play. However, although there was no decline in overall activity level at a mean of 3 years, self-assessed athletic performance was attained and maintained in approximately one-half of the study population.

Combined fuzzy logic and random walker algorithm for PET image tumor delineation.

The random walk (RW) technique serves as a powerful tool for PET tumor delineation, which typically involves significant noise and/or blurring. One challenging step is hard decision-making in pixel labeling. Fuzzy logic techniques have achieved increasing application in edge detection. We aimed to combine the advantages of fuzzy edge detection with the RW technique to improve PET tumor delineation. A fuzzy inference system was designed for tumor edge detection from RW probabilities. Three clinical PET/computed tomography datasets containing 12 liver, 13 lung, and 18 abdomen tumors were analyzed, with manual expert tumor contouring as ground truth. The standard RW and proposed combined method were compared quantitatively using the dice similarity coefficient, the Hausdorff distance, and the mean standard uptake value. The dice similarity coefficient of the proposed method versus standard RW showed significant mean improvements of 21.0±7.2, 12.3±5.8, and 18.4%±6.1% for liver, lung, and abdominal tumors, respectively, whereas the mean improvements in the Hausdorff distance were 3.6±1.4, 1.3±0.4, 1.8±0.8 mm, and the mean improvements in SUVmean error were 15.5±6.3, 11.7±8.6, and 14.1±6.8% (all P's<0.001). For all tumor sizes, the proposed method outperformed the RW algorithm. Furthermore, tumor edge analysis demonstrated further enhancement of the performance of the algorithm, relative to the RW method, with decreasing edge gradients. The proposed technique improves PET lesion delineation at different tumor sites. It depicts greater effectiveness in tumors with smaller size and/or low edge gradients, wherein most PET segmentation algorithms encounter serious challenges. Favorable execution time and accurate performance of the algorithm make it a great tool for clinical applications.

Comparative analysis of genetic diversity and its relation to heterosis in early and mid-maturity Indian cauliflower (Brassica oleracea var. botrytis L.)

An experiment involving self-incompatible line based 80 F1 hybrids in early and 54 F1 hybrids in mid-maturity groups derived from line × tester design were studied with an aim of relating genetic divergence among the parents with the magnitude of heterosis in the F1 generations and to identify suitable hybrids. The significant improvements in mean of the hybrids were observed over the parents for all the traits in both maturity groups. Mean performance of all growth and yield contributing traits of parents and hybrids were higher in mid-maturity group over early maturity. Based on cluster analysis in early maturity group six (cc-13, cc-14, 14-4-17, 351aa, Pusa Deepali and SL-7) out of eighteen inbred lines were least diverse. Line vv of cluster VI was found most diverse from the lines xx-2-6, cc-32E and cc-12 of cluster VII with inter-cluster distance of 3.88. However, in mid-maturity group the most diverse lines were ccm-8 (II) and Palam Uphar (VI) with inter-cluster distance of 5.48. The combination of heterosis and diversity analysis indicated the higher fre quency and magnitude of heterosis of hybrids derived from the parental divergence class DC3 in early maturity and DC2 in mid-maturity group suggesting moderate genetic diversity is most desirable to produce highly heterotic hybrids in Indian cauliflower. The correlation between genetic distance and the level of mid-parent heterosis was not reliable for all the quantitative traits in both early and mid-maturity group of the cauliflower. Identified hybrids 395aa x Pusa Deepali and cc-32E × 23000 in early maturity and cc-22 × Sarju Maghi and cc-22 × Palam Uphar of mid-maturity group having higher magnitude of heterosis for maximum number of desirable traits may be selected for further evaluation and commercialization.

Tympanoplasty--conchal cavum approach.

ᅟThe three well recognized tympanoplasty approaches: permeatal, postaural, and endaural, each have advantages and disadvantages. The permeatal approach is suitable only for ears with adequate canal size. The postaural approach limits visualization of the posterior eardrum margin. The endaural approach limits the view of the eardrum's anterior margin.This study describes a modified endaural approach, developed to overcome these limitations. A retrospective case series review and collection of a prospective cohort of patient reported outcome data were undertaken to assess the technique.MethodStandard incisions as used in an endaural approach are placed within the ear canal. The novel incision extends from the superior canal incision into the conchal cavum. This allows a flap of the thick, hairbearing skin from both the bony and cartilaginous portions of the canal to be raised, and everted, to provide an excellent view of the entire drum. Perichondrium can be harvested for grafting from the conchal cavum.The clinical charts of all patients operated on by the first author using this technique from 2010–2012 were retrospectively reviewed. The size and position of the perforation, size of the canal, whether primary or revision surgery, graft take rate, hearing results and the occurrence of chondritis/perichondritis were recorded.To investigate the morbidities and the acceptance by the patients of the incision/scar in the conchal cavum, all patients undergoing the procedure in the 8 months up to the end of August 2013 were prospectively recruited to complete a self-assessment Likert scale questionnaire recording postoperative pain, and satisfaction with the cosmesis of the operative site. The clinician recorded if there was any evidence of chondritis/perichondritis.ResultsA 100 % graft take rate was achieved in the 75 adults treated by the first author from 2010 to 2012 regardless of the size and position of the perforation, configuration of the canal, primary or revision surgery.Preoperative Pure Tone Audiometric (PTA) Air Bone Gap (ABG) averaged over 3 frequencies (0.5, 1 and 2 K Hz) was 19.4dB (standard deviation = 9.6, range 2 to 50). Postoperative PTA ABG average was 6.2 dB (standard deviation = 8.3, range -7 to 37), demonstrating a statistically significant post-surgery mean improvement of 13.2 dB (paired T-test, p < 0.001).Twenty-one patients who underwent the procedure in 2013, reported minimal postoperative analgesic use, and scored the acceptability of the incision scar highly (4.8 out of a maximum of 5). There was no case of chondritis/perichondritis in the 96 cases.ConclusionWhilst it is the surgeon’s decision to use a permeatal, postaural or endaural approach, the endaural approach with the conchal cavum modification is an excellent alternative to the traditionally described approaches.Trial RegistrationClinical trial number: NCT02000843 at ClinicalTrials.gov

The viability of hearing protection device fit-testing at navy and marine corps accession points.

Introduction:The viability of hearing protection device (HPD) verification (i.e., fit-testing) on a large scale was investigated to address this gap in a military accession environment.Materials and Methods:Personal Attenuation Ratings (PARs) following self-fitted (SELF-Fit) HPDs were acquired from 320 US Marine Corps training recruits (87.5% male, 12.5% female) across four test protocols (1-, 3-, 5-, and 7- frequency). SELF-Fit failures received follow-up to assess potential causes. Follow-up PARs were acquired (Experimenter fit [EXP-Fit], followed by Subject re-fit [SUB Re-Fit]). EXP-Fit was intended to provide a perception (dubbed “ear canal muscle memory”) of what a correctly fitted HPD should feel like. SUB Re-Fit was completed following EXP-Fit to determine whether a training recruit could duplicate EXP-Fit on her/his own without assistance.Results:A one-way analysis of variance (ANOVA) (N=320) showed that SELF-Fit means differed significantly between protocols (P < 0.001). Post-hoc analyses showed that the 1-freq SELF-Fit mean was significantly lower than all other protocols (P < 0.03) by 5.6 dB or more. No difference was found between the multi-frequency protocols. For recruits who were followed up with EXP-Fit (n=79), across all protocols, a significant (P < 0.001) mean improvement of 25.68 dB (10.99) was found, but PARs did not differ (P = 0.99) between EXP-Fit protocols. For recruits in the 3-freq and 5-freq protocol groups who experienced all three PAR test methods (n=33), PAR methods differed (P < 0.001) but no method by protocol interaction was found (P = 0.46). Post hoc tests showed that both EXP-Fit and SUB Re-Fit had significantly better attenuation than SELF-Fit (P < 0.001), but no difference was found between EXPFit and SUB Re-Fit (P = 0.59). For SELF-Fit, the 1-freq protocol resulted in a 35% pass rate, whereas the 3-, 5-, and 7-freq protocols resulted in >60% pass rates. Results showed that once recruits experienced how HPDs should feel when inserted correctly, they were able to properly replicate the procedure with similar results to the expert fit suggesting “ear canal muscle memory” may be a viable training strategy concomitant with HPD verification. Fit-test duration was also measured to examine the tradeoff between results accuracy and time required to complete each protocol.Discussion:Results from this study showed the critical importance of initial selection and fitting of HPDs followed by verification (i.e., fit-testing) at Navy and Marine Corps accession points. Achieving adequate protection from an HPD is fundamentally dependent on obtaining proper fit of the issued HPD as well as the quality of training recruits receive regarding HPD use.