Subjective Improvement Research Articles

(134) Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie’s Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study

Abstract Introduction Limited data currently exist on the role and efficacy of additional series of collagenase clostridium histolyticum (CCH) injections among Peyronie’s disease (PD) men who have previously failed a first series of injections. We have previously published outcomes of men undergoing a novel protocol for CCH injections and which demonstrated significant improvements compared to original IMPRESS I and II techniques. We therefore sought to evaluate results of men who had previously failed CCH injections to determine if they would respond to a repeat course using a more aggressive protocol. Objective To evaluate outcomes of a novel protocol for CCH injections among men who had previously failed 6-8 CCH injections using a traditional approach. Methods A randomized, controlled trial (NCT05108558) is ongoing. All participants had previously failed to achieve ≥20% curvature improvement with 6-8 prior CCH injections. Men were randomized 3:1 to receive either CCH + traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes were compared between treatment and control groups. Key measures included objective curve improvements and standardized/non-standardized questionnaires, with assessments obtained at baseline, 6-weeks after completion of CCH (treatment arm), after the no treatment period (controls), and at 1 year. Results A total of 22/40 men have been randomized to date, with 11 having fully completed treatment. Mean age was 64 years, with a median PD duration of 24 months. Mean composite baseline curvature was 80 degrees, with 55% having hourglass or indentation deformities, 10% calcification, median baseline IIEF-EFD 15, and 60% able to have penetrative intercourse. Median estimated improvement with the prior CCH series was 0% (IQR 0, 19.4), and the median number of prior injections was 8. The majority of men were dissatisfied with their prior series of CCH (60% vs 30% satisfied, 10% neutral). Of the 11 men who had completed the study protocol, 64% required 1 series, 9% 2 series, 18% 3 series, and 9% 4 series. Compared to the no treatment arm, treated men experienced significantly greater improvements (mean 78 degree vs 15, p=0.01). IIEF-EFD was also improved more in treated men (+4.3 vs -5.7, p<0.05). 100% of men reported a subjective major improvement in curvature, with the average subjectively estimated improvement 91%. 67% reported improved sensitivity (33% no change), while 60% reported improved or no change in erectile function, with 20% unsure, and 20% somewhat worse. Post-treatment, 83% of men were very satisfied with CCH as a treatment and 17% somewhat satisfied. Conclusions Repeating CCH using a novel protocol after an initially unsuccessful course of CCH achieves significant improvements in curvature and patient satisfaction. Additional data, including external validation, are warranted. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Matthew Ziegelmann - Endo Pharmaceuticals.

(313) Low-Intensity Extracorporeal Shockwave Therapy May Result in Improvements in Flaccid Cavernosal Artery Peak Systolic Velocity

Abstract Introduction Low-intensity extracorporeal shockwave therapy (LiESWT) is thought to treat erectile dysfunction (ED) by stimulating neovascularization and nerve regeneration. Studies suggest subjective improvements following treatment, but objective measures are sparse. Objective We aimed to objectively assess the efficacy of LiESWT in the treatment of ED using penile Doppler in men with ED following LiESWT therapy. We hypothesized that LiESWT results in demonstrable increases in penile blood flow. Methods Patients were prospectively enrolled in a clinical trial examining objective and subjective changes in erectile function following LiESWT. Patients underwent baseline examination with penile Duplex ultrasound in both the flaccid and rigid states following intracavernosal injection of alprostadil. Patients received 12 bi-weekly LiESWT treatments of 0.2mJ/mm2 at 5Hz, 1500 shocks delivered per treatment, with follow up Duplex at 1-2 weeks, 4-6 weeks, 3 months and 6 months post-treatment. Highest peak systolic velocity (PSV) and lowest end diastolic velocity (EDV) were reported. Results Twenty-five patients completed all five study visits. The mean highest PSV in the flaccid state prior to treatment was 7.86 cm/s (± 1.47), which significantly increased to 11.31 cm/s (± 1.81, p < 0.05) immediately following completion of treatments. This increase was sustained at 4-6 weeks with a mean PSV of 12.74 cm/s (± 1.80, p < 0.05), followed by 10.74 cm/s (± 1.43, p < 0.05) at 3 months, and 9.87 cm/s (± 1.14, p=0.11) at 6 months (Figure 1). No significant improvements were noted in flaccid lowest EDV or rigid peak PSV/lowest EDV. Conclusions Our results suggest that LiESWT may improve baseline penile vascularity. Overall, the clinical significance of the noted improvement in flaccid PSV after LiESWT remains to be determined and more work needs to be done to define the mechanism of action of LiESWT at a tissue level in human subjects. Disclosure No.

(162) Evaluating the Effectiveness of Testosterone Therapy Combined with PDE5 Inhibitors in Enhancing Erectile Function in Eugonadal Men

Abstract Introduction Historically, testosterone therapy (TTh) is not indicated in eugonadal men with erectile dysfunction (ED). Moreover, the 2018 AUA Guidelines state that TTh is not indicated as monotherapy for men suffering from ED but should be considered as combination therapy with PDE5i, as TTh may increase the efficacy of PDE5i therapy. Objective We investigated the benefits of providing TTh in combination with PDE5i therapy in marginally eugonadal men to determine its efficacy in improving erectile function. Methods A retrospective chart review was performed on men presenting with ED to an academic institution’s Men’s Health Clinic from 2010 to 2022. Objective data was gathered on key variables that affected patient-reported outcomes of ED, including age at presentation and comorbidities, as well as use of TTh and use of oral PDE5i. 177 eugonadal men were selected with the criteria of testosterone levels >300 ng/dL on initial presentation. Results were then statistically analyzed using a two-tailed student’s T test in R and p-values to determine the significance between variables and outcomes in ED. Results Out of our cohort of 179 eugonadal men presenting with ED, 42 patients were continued or started on concurrent TTh with oral PDE5i therapy added, and 83 were started on PDE5i monotherapy. Men in the dual-therapy group excluding those already on TTh began with a pre-therapy testosterone mean of 412.3 ng/dL compared to 443.0 ng/dL which was insignificant (p=0.22). There were no significant differences in presenting age (p=0.61) or comorbidities including hypertension (p=0.89) and diabetes (p=0.63) between the two groups. Additionally, there were no significant differences in lab values of HgA1c (p=0.34), cholesterol (p=0.80), triglycerides (p=0.27), or LDL (p=0.89). However, there was a lower initial HDL in the combination group of 45.1 mg/dL compared to 55.8 mg/dL (p = 0.036). Men in the dual-therapy group were more likely to report subjective improvement in ED symptoms compared to men taking PDE5is alone. This was supported by 33/42 (78.6%) of men in the dual therapy group reporting improved erectile function compared to 49/83 (59.0%) of men in the PDE5i only group (p = 0.029). Conclusions In conclusion, these results demonstrate that treatment of eugonadal men with concurrent TTh and PDE5i therapy demonstrated a significant improvement in erectile function as compared to PDE5i therapy alone. These findings suggest consideration of testosterone therapy in addition to PDE5i in clinical practice when treating marginally eugonadal men presenting with ED. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Consultant for AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast Investor: Sprout.

Intraplaque injections of hyaluronic acid for the treatment of stable-phase Peyronie's disease: a retrospective single-center experience.

Peyronie's disease (PD) is a condition of penile connective tissue affecting up to 10% of men worldwide. In the complexity of its management, nonsurgical treatments, such as intraplaque injections, are gaining attention. The current literature shows data on the efficacy of intraplaque injections of hyaluronic acid (HA) mainly in acute-phase PD. However, data on injections of HA in stable-phase PD are lacking. Data for this retrospective study were derived from a prospectively maintained database of private patients presenting at a private medical practice affiliated to the University of Naples "Federico II" (Naples, Italy) with stable-phase PD between January 2020 and March 2023. Patients underwent a standard protocol of three injections, each administered at a two-week interval. During the intervals, patients performed vacuum device therapy, penile stretching, and modeling exercises. All patients compiled the Peyronie's Disease Questionnaire (PDQ) and Global Assessment of Peyronie's Disease (GAPD) at baseline and 2 weeks after the third injection. A penile Doppler ultrasound was performed 2 weeks after the last injection to record the final curvature. Overall, we recruited 62 patients with stable-phase PD and a mean (±standard deviation [s.d.]) curvature of 52.7° (±9.7°). After 6 weeks, eight (12.9%) patients did not experience any curvature improvement. The remaining 54 patients had a final mean (±s.d.) curvature of 40.3° (±9.1°) with P < 0.001, compared to that before treatment. We found improvement in all PDQ domains (all P ≤ 0.01), and 50 (80.6%) patients reported subjective improvement of the penile curvature according to the GAPD. In conclusion, we demonstrated that after three injections of HA administered according to the adopted protocol, patients with stable-phase PD could experience significant improvements in penile curvature, and physical and psychological consequences of the disease without significantly relevant side effects.

Dubbing language-therapy CINEma-based in aphasia post-stroke (DULCINEA): A feasibility randomized crossover controlled trial.

Helping people recover from aphasia is among the top 10 research priorities relating to life after stroke. We aimed to evaluate the feasibility of dubbing techniques (using newly developed software) for post-stroke aphasia therapy and explore its potential efficacy. Randomised, crossover, interventional, feasibility trial that included patients with chronic post-stroke non-fluent aphasia. The intervention consisted of an individualised programme (16 sessions; 8 weeks) based on dubbing words and sentences progressively adapted to the severity of the aphasia. Patients were allocated to groups that underwent therapy within the first 3 months, or between 3 and 6 months from inclusion, each group serving as the control during the non-therapy periods. Outcomes were the pre-post differences in the Communicative Activity Log, the Boston Diagnostic Aphasia Examination, the General Health Questionnaire-12, the Stroke Aphasia Quality of Life Scale, and the Western Aphasia Battery Revised, administered by psychologists blinded to the patients' allocation. Recruitment was limited due to COVID-19 and prematurely stopped because of funding coming to an end. A total of 23 patients were randomised, 20 of whom completed the study (1 withdrew consent, and 2 dropped out). The adherence rate to the allocated group was 95.3%. No statistically significant differences were found in any of the outcomes; however, 17 (85%) patients reported subjective improvements in communication skills. This trial shows the feasibility of dubbing therapy (using dedicated software) for patients with post-stroke non-fluent aphasia. Although it lacks statistical power, certain effects on language and communication cannot be ignored.

Diagnostic Challenges of Ocular Rosacea.

This study aims to address the issues surrounding the diagnosis of ocular rosacea and to evaluate the development of the patients’ condition after treatment, as well as to distinguish between healthy and diseased patients using a glycomic analysis of tears. A prospective study was conducted to assess a total of 68 eyes in 34 patients over a six-week period. These patients were diagnosed with ocular rosacea based on subjective symptoms and clinical examination. The study monitored the development of objective and subjective values. The difference between patients with the pathology and healthy controls was established by means of analysis of glycans in tears. Skin lesions were diagnosed in 94% of patients with ocular rosacea, with the most commonly observed phenotype being erythematotelangiectatic (68.8%). The mean duration of symptoms was 29.3 months (range 0.5–126 months) with a median of 12 months. Throughout the study, an improvement in all monitored parameters was observed, including Meibomian gland dysfunction, bulbar conjunctival hyperemia, telangiectasia of the eyelid margin, anterior blepharitis, uneven and reddened eyelid margins, and corneal neovascularization. The study also observed improvements in subjective manifestations of the disease, such as foreign body sensation, burning, dryness, lachrymation, itching eyes, photophobia, and morning discomfort. The analysis of glycans in tears partially separated tear samples based on their origin, which allowed for the differentiation of patients with rosacea from healthy controls. In the first sample, the pathology was determined in a total of 63 eyes (98.4%) of 32 patients, with further samples showing a change in the glycomic profile of patients’ tears during treatment. The study demonstrated objective and subjective improvements in all the patients. Tear sampling and analysis could provide a means of timely diagnosis of ocular rosacea.

Immediate and Delayed Effects of Punctal Plug Insertion on Tear Meniscus Height in Severe Aqueous-Deficient Dry Eye.

The aim of this study was to assess the immediate and delayed effects of tear punctal occlusion with punctal plugs on tear meniscus height (TMH) in severe aqueous-deficient dry eye (ADDE) disease. Consecutive patients with severe ADDE related to Sjögren syndrome or ocular graft-versus-host disease underwent inferior and superior occlusion with punctal plugs. TMH was measured using the LacryDiag ocular surface analyzer platform before, 10 minutes, and at least 1 month after punctal occlusion. The corneal fluorescein staining (CFS) score was graded with the Oxford scale (from 0 to 5). Ocular symptoms were graded with a visual analog scale (from 1 to 10). We included 24 eyes of 24 patients (mean age 61 ± 9 years; mean follow-up 7 ± 5 months). The mean TMH was 0.19 ± 0.06 mm at baseline and increased significantly to 0.41 ± 0.13 mm (P < 0.001) and 0.46 ± 0.17 mm (P < 0.001) at 10 minutes after punctal plug insertion and at the end of follow-up, respectively. The median CFS score decreased from 3 ± 1 before plug insertion to 1 ± 2 at the end of follow-up (P < 0.001). Many patients (67%; n = 16) reported subjective improvement of symptoms. TMH was negatively correlated with the CFS score and visual analog scale score assessing symptoms. Upper and lower punctal occlusion increased TMH in patients with severe ADDE as soon as 10 minutes after plug insertion. TMH remained stable over time, which led to the relief of symptoms and reduced corneal staining.

Unlocking tracheoesophageal speech from pharyngoesophageal spasm: preliminary results of a videofluoroscopic-guided botulinum toxin A injection technique.

The tracheoesophageal puncture for the voice prosthesis (VP) placement is the recognized gold standard in post-laryngectomy voice rehabilitation. Despite the development of specific intraoperative techniques, a subset of patients will suffer from poor functional outcomes due to pharyngoesophageal spasms (PES). This paper evaluates the functional outcomes after transcutaneous botulinum toxin type A (BTX-A) infiltration for PES with a videofluoroscopy-guided technique. Since 2022, eight consecutive patients with VP and affected by PES were treated with BTX-A injection by a standard videofluoroscopic guided technique at the European Institute of Oncology, IRCCS (IEO) in Milan. A lidocaine test was performed pre-operatively to evaluate the potential effect of chemical neurectomy. All patients with positive lidocaine tests were injected with 50IU of BTX-A (Allergan, Irvine, CA) according to the sites marked during the videofluoroscopy. Reported symptoms (VHI, SECEL), perceptual (INFVo), aerodynamic (MPT) and manometric parameters were collected before and after treatment. In all cases, BTX-A was performed as an outpatient procedure without complications. For seven patients, only one BTX-A injection was needed, while one patient required a re-injection. Subjective and perceptive improvement after BTX-A was significant for VHI, SECEL and INFVo. MPT showed significant improvement after a chemical neurectomy. After a mean follow-up of 6months, all patients maintained a good TES quality. The videofluoroscopic guided BTX-A injection of the pharyngoesophageal tract showed to be a feasible and reproducible technique in all cases. The pharyngoesophageal videofluoroscopy allows defining of patients' anatomical landmarks that help the surgeon to perform a homogeneous injection, empowered by post-injection massage.

P997 New Objective Assessment of perianal Crohn’s disease, Perianal Lesion Index; PLI

Abstract Background In the previous survey, decisions of biological treatment (Bio) success for perianal Crohn’s disease (pCD) were made by the patient’s subjective improvement and physician’s assessment, so it lacks objectivity. Moreover, physicians, surgeons, and proctologists are related to treating pCD. This aspect is the difficulty of the treatment of pCD. We need a common assessment for each area’s doctor. We aimed to develop a new objective assessment of pCD, including endoscopic findings, and assess the efficacy of the newly launched Bio except anti-TNFα agents for pCD. Methods Usually, perianal abscesses and fistula are derived from ulcers in the lower rectum and anal canal, so we adapted SES-CD to the location and checked discharge and needs of setons, and finally scored it (Table 1). We named this assessment Perianal Lesion Index; PLI. We retrospectively evaluated 20 pCD patients who received Ustekinumab (UST) and Vedolizumab (VDZ) from March 2017 to March 2023 at our institute. We checked each patient’s PLI, CRP, LRG, and CDAI and compared them before starting Bio and eight weeks after initiation of Bio using a paired T-test. Finally, we used the Pearson correlation coefficient to examine the correlation between PLI and conventional serum biomarkers and CDAI. Results The male-to-female ratio was 4.0, the average age at the treatment initiation was 35. Eighteen patient’s diseases were located in the small and large intestines, 10 patients were penetrating type, and 2 patients were stenotic type. We used UST for 16 patients and VDZ for 4 patients. Seven patients were naïve for Bio, 8 patients were treated by one Bio, and 5 patients were treated by two Bio.PLI was positively correlated with CRP (r=0.59, p&amp;lt;0.001) but not correlated with LRG (r=0.77, p=0.077) and CDAI (r=0.35, p=0.07). The pretreatment average PLI was 8.5 and significantly decreased to 3.9 (p&amp;lt;0.001) 8 weeks after Bio initiation. There was a significant change in CRP (3.1 to 0.9, p =0.03) but not CDAI (193 to 147, p=0.2). There were significant PLI changes in each treatment group; the UST group’s PLI change was 8.3 to 3.1 (p&amp;lt;0.001), and the VDZ group's PLI was 9.5 to 8.0 (p=0.02) (Figure 1). Conclusion PLI seems to be an objective assessment for pCD, and it was positively correlated to CRP. We could assess each drug’s efficacy for pCD. Further investigation is needed to establish PLI’s accuracy, and we hope this assessment will contribute to the choices of Bio for pCD and the evaluation of its efficacy

Association of Tecovirimat Therapy With Mpox Symptom Improvement: A Cross-sectional Study-King County, Washington, May-October 2022.

Data on tecovirimat effectiveness for human mpox are limited. We conducted a retrospective cross-sectional interview-based study to identify associations between tecovirimat treatment and the mpox clinical course. Using public health surveillance data from King County, Washington, we recruited and interviewed persons diagnosed with mpox during May-October 2022. We calculated descriptive statistics on demographics, vaccination status, comorbidities, and symptoms including 3 self-reported dates (symptom onset, first date of symptom improvement, and illness resolution). We used multivariable linear regression, stratified by illness severity, to evaluate the association of tecovirimat treatment with time to symptom improvement and time to illness resolution. We compared individuals who did not receive tecovirimat to participants who started tecovirimat early (≤5 days from symptom onset) and late (>5 days and ≤28 days from symptom onset) in their illness. Of 465 individuals diagnosed with mpox, 115 (25%) participated in this study. Eighty participants (70%) received tecovirimat and 43 (37%) initiated tecovirimat early. Sixty-eight (59%) reported severe symptoms during their illness, including proctitis (n = 38 [33%]), rectal bleeding (n = 27 [24%]), or severe pain (n = 24 [21%]). In the multivariable analysis, early tecovirimat was associated with shorter time to symptom improvement (-5.5 days, P = .04) among participants with severe illness but not among those with nonsevere illness (0.9 day, P = .66). Early tecovirimat was not associated with faster illness resolution, regardless of severity. Our small study suggests that early tecovirimat initiation may hasten subjective symptomatic improvement in people with severe mpox. Larger randomized trials are needed to evaluate this finding.

Enhancing social-emotional functioning in adolescents with developmental language disorder or deaf or hard of hearing through a Theory of Mind intervention.

This study examines the effect of a Theory of Mind (ToM) intervention on ToM abilities and social-emotional functioning in adolescents with developmental language disorder (DLD) or who are deaf/hard of hearing (D/HH). It emphasizes the importance of self-reflection and measurement for personal growth. The research design incorporates both subjective and objective measures to evaluate the intervention's efficacy. To investigate the impact of the ToM intervention on ToM abilities and social-emotional functioning in adolescents with DLD or who are D/HH. It hypothesizes that participants in the intervention groups will show improved ToM and social-emotional functioning compared with those in the control groups. Adolescents with DLD or who are D/HH were recruited through collaboration with educational institutions. The study utilized a pre-/post-test design, assigning participants to either the intervention or the control group. The ToM intervention involved targeted activities to enhance ToM abilities. ToM abilities and social-emotional functioning were assessed using standardized tests and self-report questionnaires. Statistical analyses compared outcomes between the intervention and no intervention groups. The findings reveal subjective improvements in social-emotional functioning among the D/HH intervention group. However, no significant effects on objective ToM measures were observed. These results highlight the need for further investigation and refinement of interventions in these areas. Future research should focus on improving intervention strategies and exploring additional objective measures to gain a comprehensive understanding of the intervention's impact on ToM and social-emotional functioning in this population. The ToM intervention shows subjective benefits in improving social-emotional functioning among D/HH adolescents. However, it does not yield significant effects on objective ToM measures. These findings emphasize the ongoing need to refine interventions targeting ToM abilities and social-emotional functioning in this population. Future studies should explore alternative strategies and incorporate additional objective measures to enhance understanding and outcomes. What is already known on this subject Before this study, it was known that ToM interventions have the potential to enhance ToM abilities. However, the specific effects of such interventions on subjective and objective measures for ToM and social-emotional functioning in adolescents with DLD or who are D/HH remained unclear, necessitating further research. What this paper adds to the existing knowledge This study adds to the existing knowledge by demonstrating subjective improvements in social-emotional functioning among adolescents who are D/HH and underwent a ToM intervention. However, no significant effects on objective ToM measures were observed. These findings highlight the need for refining interventions and exploring additional measures to better understand the intervention's impact. What are the potential or actual clinical implications of this work? The subjective improvements in social-emotional functioning observed in this study have important clinical implications. They suggest that ToM interventions can positively impact the social well-being of adolescents who are D/HH. However, the lack of significant effects on objective ToM measures emphasizes the need for further research and intervention refinement to address specific areas of improvement in this population.

Determinants of Subjective Mental and Functional Health of Critical Illness Survivors: Comparing Pre-ICU and Post-ICU Status.

To compare ICU survivors' subjective mental and functional health before ICU admission and after discharge and to assess determinants of subjective health decline or improvement. Secondary analysis of the multicenter cluster-randomized Enhanced Recovery after Intensive Care trial ( ClinicalTrials.gov : NCT03671447). Ten ICU clusters in Germany. Eight hundred fifty-five patients with 1478 follow-up assessments. None. At two patient follow-ups scheduled 3 and 6 months after ICU discharge, patients rated their subjective mental and functional/physical health on two separate visual analog scales from 0 (worst) to 10 (best) in the previous week and before ICU admission. We compared pre-ICU and post-ICU subjective health and used mixed-effects regression to assess determinants of a health decline or improvement. At the first follow-up, 20% ( n = 165/841) and 30% ( n = 256/849) of patients reported a decline in subjective mental and functional health of at least three points, respectively; 16% ( n = 133/841 and n = 137/849) outlined improvements of mental and functional health. For 65% ( n = 543/841) and 54% ( n = 456/849), mental and functional health did not change three points or more at the first follow-up. Multivariable mixed-effects logistic regressions revealed that the ICU length of stay was a predictor of mental (adjusted odds ratio [OR] per ICU day, 1.04; 95% CI, 1.00-1.09; p = 0.038) and functional health (adjusted OR per ICU day, 1.06; 95% CI, 1.01-1.12; p = 0.026) decline. The odds of a mental health decline decreased with age (adjusted OR per year, 0.98; 95% CI, 0.96-0.99; p = 0.003) and the odds of a functional health decline decreased with time after discharge (adjusted OR per month, 0.86; 95% CI, 0.79-0.94; p = 0.001). The majority of ICU survivors did not experience substantial changes in their subjective health status, but patients with long ICU stays were prone to subjective mental and functional health decline. Hence, post-ICU care in post-ICU clinics could focus on these patients.

Quality of life, hearing results, patient satisfaction and postoperative complications of day-case versus inpatient unilateral cochlear implantation in adults: a randomized controlled, equivalence trial

ObjectiveTo investigate the hypothesis that day-case cochlear implantation is associated with equal quality of life, hearing benefits and complications rates, compared to inpatient cochlear implantation.Study designA single-center, non-blinded, randomized controlled, equivalence trial in a tertiary referral center.MethodsThirty adult patients with post-lingual bilateral sensorineural hearing loss eligible for unilateral cochlear implantation surgery were randomly assigned to either the day-case or inpatient treatment group. The effect on general quality of life, patient satisfaction, (subjective) hearing improvement, postoperative complications and causes of crossover and/or readmission were assessed using questionnaires, auditory evaluations and patients’ charts over a follow-up period of 1 year.ResultsOverall quality of life measured by the HUI3 was equal between the day-case (n = 14) and inpatient group (n = 14). The overall patients’ satisfaction showed a slight favor towards an inpatient approach. There was no significant difference in the subjective and objective hearing improvement between both treatment groups. During the 1-year follow-up period no major complications occurred. Minor complications occurred intraoperatively in three day-case patients resulting in three out of nine admissions of day-case patients. Other causes of admission of day-case patients were nausea and vomiting (n = 1), drowsiness (n = 1), late scheduled surgery (n = 2), social reasons (n = 1), or due to an unclear reason (n = 1). No patients required readmission.ConclusionWe found equal outcomes of QoL, patient satisfaction, objective, and subjective hearing outcomes between day-case and inpatient unilateral cochlear implantation. Nine out of 14 day-case patients were admitted for at least one night postoperatively (crossover). No major complications occurred in both groups. A day-case approach seems feasible when using specific patient selection, surgical planning and the preoperative provision of patient information into account. Besides this, the familiarity with a day-case approach of both patient and the surgical team can increase the feasibility of day-case surgery.Level of evidence1.

Construction and Application of Physical Education Classroom Teaching Model Integrating MOOC and Flipped Classroom

In terms of sports itself, mastering certain skills is a reliable way to avoid injury and futile training, and the teaching process needs to focus on imparting skills. Therefore, in order to optimize the teaching mode of physical education courses, this study explores the current improvement achievements and draws on the advancement of curriculum reform. The study proposes a recommendation method based on knowledge points and student characteristics by studying the characteristics and importance of sports techniques, in order to achieve high-quality customized content recommendations. Through validation experiments, the effectiveness of this recommendation method and optimization path is demonstrated. This study adopts an empirical research design to explore the impact of recommendation methods based on knowledge points and student characteristics on the teaching effectiveness of physical education courses. The effectiveness of this recommendation method is evaluated by collecting and analyzing students' learning data. Statistical analysis methods are used to analyze experimental data, including calculating the percentage of improvement in students' technical movements under different teaching modes. The research results indicated that recommendation methods based on knowledge points and student characteristics were of great significance for optimizing the teaching mode of physical education courses. The improvement of subjects' technical movements such as hitting and swinging in the new teaching mode was significantly better than that in the traditional teaching mode, with an increase of 10-20 technical movements per unit time, with a growth rate of over 20%. Compared with traditional teaching models, this teaching model has been subjectively recognized by students and has positive reference significance for the current physical education teaching model.

Stability of Ocular Alignment After Teprotumumab Therapy in a Cohort of Patients With Thyroid Eye Disease and Baseline Diplopia.

Teprotumumab is a monoclonal antibody that is effective in treating patients with thyroid eye disease (TED) and has been shown to produce subjective improvements in diplopia in this group. The aims of this study were to evaluate the rate and timing of recurrence/worsening of diplopia after teprotumumab treatment in a cohort of patients with TED presenting with diplopia at baseline. A retrospective chart review of 15 patients with diplopia secondary to TED, treated with teprotumumab, was conducted in a single-center academic institution. The primary outcome was the rate of recurrence/worsening of diplopia after completing teprotumumab. Secondary outcomes include the time to recurrence/worsening of diplopia and clinical activity scores (CAS) to correlate with changes in ocular alignment. Fifteen patients met the inclusion criteria for this study, and 7 of these had recurrence of diplopia (46.7%). Two patients had worsening of CAS to ≥4, 6 had worsening of CAS to 3, and the other 7 had CAS ≤2 during the follow-up period. The mean follow-up period was 20.4 months (SD 7.2) after completing teprotumumab. The mean time to diplopia recurrence/worsening was 8.8 months (range 6.7-12.2, SD 1.8). Patients with TED and baseline diplopia have a substantial rate of recurrence/worsening of diplopia after teprotumumab therapy, suggesting that they may not have stable ocular alignment immediately after treatment. Strabismus surgeons may need to weigh the significant risk of disease relapse when planning optimum timing for surgical correction.

Risdiplam Real World Data - Looking Beyond Motor Neurons and Motor Function Measures.

Risdiplam is an orally administered treatment for spinal muscular atrophy which leads to an improvement in motor function as measured by functional motor scales compared with placebo. Although risdiplam has been registered since 2020, real-world data in adults is still scarce. There have been no new safety signals so far, with some results pointing that risdiplam may be effectiveObjective:The objective was to present real-world data of 31 adult patients with spinal muscular atrophy type 2 and type 3 treated with risdiplam in the Republic of CroatiaMethods:Treatment effects were assessed with motor function tests and patient reported outcome measures, including Individualized Neuromuscular Quality of Life questionnaire, and Jaw Functional Limitation Scale. Side effects, as well as subjective improvements and symptoms, were noted. Majority of patients did not report any side effects. During treatment, we have observed clinically meaningful improvements in some patients, with stabilization of motor functions in the remaining patients. The majority of patients with bulbar function impairment experienced bulbar function improvement, all patients reported an increased quality of life with treatment. An unexpected observed treatment effect was weight gain in a third of all patients with some patients reporting an increase in appetite and subjective improvement in digestion. Risdiplam treatment was well tolerated with subjective and objective positive outcomes registered as measured by functional motor scales and patient-reported outcomes. Since risdiplam is administered orally and acts as a systemic therapy for a multisystemic disorder, effects in systems other than neuromuscular can be expected and should be monitored. Due to systemic nature of the disease patients need multidisciplinary monitoring.

Neurectomy and Myomectomy for Treatment of Spasmodic Dysphonia.

Spasmodic dysphonia (SD) is a debilitating neurological disorder affecting the muscles of voice production. Sudden involuntary movements of the vocal folds lead to phonatory breaks and to forced, strained, and strangled voice quality in adductor SD, or breathy breaks in abductor SD. There is currently no cure for spasmodic dysphonia, and the gold standard for treatment is the injection of botulinum toxin in small amounts to the intrinsic laryngeal musculature.1 However, botulinum treatment requires periodic reinjection, produces vocal instability immediately after injection, lacks uniform results among patients, and patients can develop antibodies to botulinum toxin. Long-term or permanent symptom relief would be ideal. We present four patients with adductor and one patient with abductor spasmodic dysphonia who underwent neurectomy and myomectomy for treatment. The mean age was 64 years (age range 45-83). The mean duration of adductor spasmodic dysphonia was 11.8 years. The duration of abductor spasmodic was 4 years. All patients had previously been treated with voice therapy and botulinum toxin A. The mean duration of follow up was 1.7 years. Four patients had subjective and objective improvement after surgery. One patient had subjective improvement.

Long-term Outcomes After Surgical Reconstruction of Multiligamentous Knee Injuries: Results at Minimum 10-Year Follow-up.

Multiligamentous knee injuries (MLKIs) are devastating injuries with concomitant injuries that complicate treatment and recovery. Short-term studies have shown satisfactory patient outcomes after surgical treatment; however, evaluations of long-term outcomes remain scarce. To evaluate long-term outcomes after surgically reconstructed MLKIs and further investigate the relationship between patient age on clinical outcomes. Case series; Level of evidence, 4. A total of 55 knees (age, 36 ± 11 years; 24% female subjects) who underwent surgical reconstruction for MLKI between 1992 and 2013 met the study inclusion criteria and were evaluated with postoperative patient-reported outcomes (PROs) including International Knee Documentation Committee (IKDC) score, Lysholm score, visual analog scale (VAS) for pain, Forgotten Joint Score, subjective improvement ratings and surgery satisfaction, and Tegner activity scores. PRO scores, revision, and conversion to arthroplasty were analyzed using descriptive statistics, linear regression, Wilcoxon rank-sum, and Fisher exact tests. At final follow-up (mean, 15 ± 5 years; range, 10-31 years), 67% of the cohort reported subjective improvement in their knee, and 82% reported satisfaction with their surgery. Compared with preoperative scores, there were significant improvements in postoperative VAS pain at rest in the full cohort, age ≤30-year cohort, and age >30-year cohort (4 ± 1 vs 2 ± 2; 4 ± 1 vs 2 ± 3; 4 ± 1 vs 1 ± 2, respectively; P≤ .029 for all) but significant reductions in Tegner scores (6 ± 3 vs 4 ± 2; 7 ± 2 vs 5 ± 2; 5 ± 2 vs 3 ± 1; P≤ .003 for all). Younger patients had higher postoperative Tegner scores than older patients (5 ± 2 vs 3 ± 1, respectively; P = .003), but no other differences in PROs were observed based on age. At a mean 15-year follow-up, 3.6% of the cohort underwent revision ligament surgery and 10.9% required arthroplasty. The majority of the cohort reported modest subjective improvement and were satisfied with their surgery. Gradual but expected age-related decreases in Tegner scores were observed, and some patients demonstrated continued symptomatic and functional limitations, but mean PRO scores remained satisfactory. Revision surgery and conversion to arthroplasty were not commonly required.

A prospective comparative study of efficacy and safety of 15% trichloroacetic acid peel, 35% glycolic acid peel and Q-switched Nd-YAG laser in patients of macular amyloidosis.

The unappealing appearance of skin in macular amyloidosis (MA) interferes with the patient's quality of life, and treating the condition has been challenging. To compare the efficacy and safety of 15% trichloroacetic acid (TCA) peel, 35% glycolic acid (GA) peel, and Q-switched Nd-YAG Laser in MA. Open, prospective study was conducted over 2 years, where after fulfilling the criteria, randomization was done into three groups. Group A: 15% TCA peel; Group B: 35% GA peel; Group C: Q-switched Nd-YAG Laser. Procedures were repeated at monthly intervals for six sittings. On each visit, patients were scored on the following parameters: color score, visual analog score (VAS), physician global assessment (PGA) scale, subjective improvement, and adverse effects. A total of 75 patients (25 patients in each group) completed the treatment. The mean age of study-population was 35.68 ± 9.8 years, with female to male ratio of 11.5:1. The mean change in color score (1.68) was more by Group A, followed by Group C (1.4), followed by Group B (1.16). Similar results were noted by subjective improvement, VAS, and PGA. Adverse events were more in Group A, followed by Group C, followed by Group B. No patient showed permanent adverse events. TCA-peel showed superior results over Nd-YAG laser and glycolic-acid peel. TCA-peel being cost-effective with excellent acceptability should be considered a treatment modality.

Long‐term response to idebenone treatment in a patient with advanced Leber hereditary optic neuropathy

Aims/Purpose: To present a case with advanced LHON and its response to 2‐year‐treatment with idebenone, which was prescribed 13 years after the onset of the disease.Methods: A 40‐year‐old Caucasian male patient with a history of bilateral painless visual loss since the age of 28 was examined at our Ophthalmology department. His brother had also suffered similar visual loss. At presentation ETDRS best corrected visual acuity (BCVA) was counting fingers (CF) in both eyes (BE). Fundoscopy revealed pale optic discs bilaterally. Visual fields (30‐2) showed central scotomas in BE. During OCT/OCTA imaging of the optic disc RNFL and GCC thickness were decreased bilaterally. In electrophysiological assessment with flash visual evoked potentials a reduction in amplitude was recorded in BE but with normal latency. Full‐field ERG was within normal limits in BE. At the genetic test, a mitochondrial point mutation m. 3460 G&gt;A at MT‐ND1 gene was detected, which was compatible with LHON. The patient was prescribed 300 mg idebenone per os three times/day for 24 months. Follow‐up visits were scheduled at 6, 12, 18 and 24 months.Results: At 6‐ and 12‐month follow‐up visits visual acuity, fundoscopic findings and OCT‐RNFL imaging remained unchanged. However, the patient reported subjective visual improvement bilaterally, with greater improvement in the visual field of the left eye. At 18 months following initiation of treatment an improvement of the visual field was documented in BE. No change of the GCC thickness was noted. At 2‐year follow‐up his condition remained improved.Conclusions: Delayed treatment with idebenone in advanced LHON can lead to subjective visual improvement. Moreover, an improvement in visual fields can also be documented even after 18 to 24 months of the initiation of the treatment.