Function Domain Score Research Articles

Association of Pulmonary Involvement at Baseline with Exercise Intolerance and Worse Physical Functioning 8 Months Following COVID-19 Pneumonia

Objectives: We aimed to describe the cardiopulmonary function during exercise and the health-related quality of life (HRQoL) in patients with a history of COVID-19 pneumonia, stratified by chest computed tomography (CT) findings at baseline. Methods: Among 77 consecutive patients with COVID-19 who were discharged from the Pulmonology Ward between March 2020 and April 2021, 28 (mean age 54.3 ± 8.6 years, 8 females) agreed to participate to the current study. The participants were analyzed in two groups based on pulmonary involvement (PI) at baseline chest CT applying a threshold of 25%. A consequent artificial intelligence (AI)-guided total opacity score (TOS) was calculated in a subgroup of 22 patients. A cardiopulmonary exercise test (CPET) was conducted on average 8.4 (±1.9) months after discharge from the hospital. HRQoL was defined using the short-form (SF-36) questionnaire. The primary outcome was exercise intolerance that was defined as a peak oxygen uptake (V′O2peak) < 80% predicted. Secondary outcomes were ventilatory limitation, defined as breathing reserve < 15%, circulatory limitation, defined as oxygen pulse predicted below 80%, and deconditioning, defined as exercise intolerance in the absence of ventilatory and circulatory limitations. Other secondary outcomes included the SF-36 domains. Results: In all, 15 patients had at least 25% PI (53.6%) at baseline chest CT. Exercise intolerance was observed in ten patients (35.7%), six due to deconditioning and four due to circulatory limitation; none had ventilatory limitation. AI-guided TOS was 30.1 ± 24.4% vs. 6.1 ± 4.8% (p < 0.001) at baseline, and 1.7 ± 3.0% vs. 0.2 ± 0.7% (nonsignificant) at follow-up in high and low PI groups, respectively. The physical functioning (PF) domain score of the SF-36 questionnaire was 66.3 ± 19.4 vs. 85.0 ± 13.1 in high and low PI groups, respectively (p = 0.007). Other SF-36 domains did not differ significantly between the groups. A high PI at baseline was inversely correlated with V′O2peak (standardized β coefficient = −0.436; 95% CI −26.1; −0.7; p = 0.040) and with PF scores (standardized β coefficient −0.654; 95% CI −41.3; −7.6; p = 0.006) adjusted for age, sex, body mass index and lung diffusion capacity. Conclusions: One-third of participants experienced exercise intolerance eight months after COVID-19 pneumonia. A higher PI at baseline was significantly associated with exercise intolerance and PF. Notwithstanding, the radiological PI was resolved, and the exercise intolerance was mainly explained not by ventilatory limitation but by circulatory limitation and deconditioning.

Efficacy of Hongjing I granule, an herbal medicine, in patients with mild to moderate erectile dysfunction in a randomized controlled trial.

HJIG is a potential treatment for erectile dysfunction (ED) that has been used in China for over 20years. We conducted a multi-center, double-blind, randomized, placebo-controlled trial to evaluate the effectiveness and safety of the Chinese Herbal Medicine, Hongjing I granule (HJIG), in patients with mild to moderate erectile dysfunction (ED). This study is structured as a randomized, double-blind, placebo-controlled trial, executed across multiple centers. The recruitment strategy is primarily oriented towards patients demonstrating a pronounced preference for solely leveraging traditional Chinese medicine (TCM) interventions, a preference that is widely observed within TCM healthcare settings. A total of 100 patients, presenting with mild to moderate ED, specifically linked to the traditional diagnostic criteria of qi deficiency and blood stasis, will be enrolled. These participants will be randomly distributed between the HJIG (N = 50) and placebo (N = 50) arms. The designated treatment period is set at 8weeks. Primary outcome measures encompass the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score, the Sexual Encounter Profile (SEP), and scores derived from the traditional Chinese medicine symptom evaluation. Of the 122 men enrolled, the baseline IIEF-EF score averaged 16.00 [IQR: 13.00, 18.00]. Eight weeks post-randomization, the HJIG group demonstrated a mean change in IIEF-EF scores of 7.80 (±3.25), compared to 3.33 (±3.90) in the placebo group, signifying a marked difference (P < 0.001). The median alterations in SEP3 scores were 0.50 [IQR: 0.36, 0.75] for the HJIG group and 0.50 [0.20, 0.67] for the placebo group, revealing a statistically relevant distinction (P = 0.05). In both primary outcomes, HJIG proved superior to the placebo. Additionally, improvements in TCM symptom scores were notably greater in the HJIG group relative to the placebo, with no adverse events reported across both groups. The Hongjing I granule significantly improved symptoms in patients with mild to moderate ED. However, to validate these findings, further extended randomized trials are warranted. The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) and the registration number was ChiCTR2000041127.

Home-Based Exercise and Self-Management After Lung Cancer Resection

Patients with lung cancer have poor physical functioning and quality of life. Despite promising outcomes for those who undertake exercise programs, implementation into practice of previously tested hospital-based programs is rare. To evaluate a home-based exercise and self-management program for patients after lung resection. A randomized clinical trial with assessor blinding was conducted among 116 patients undergoing surgery for non-small cell lung cancer from November 23, 2017, to July 31, 2023, at tertiary hospitals in Australia. Patients were followed up for 12 months postoperatively. Patients randomized to the intervention group received a postoperative 3-month home-based exercise and self-management program, supported by weekly physiotherapist-led telephone consultations. Patients randomized to the control group received usual care. The primary outcome was self-reported physical function (30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC QLQ-C30] score) at 3 months. Secondary outcomes included objective measures of physical function and exercise capacity (at 3 and 6 months) and patient-reported outcomes including quality of life (at 3 and 6 months, with some questionnaires completed at 12 months). Analysis was performed on an intent-to-treat basis. A total of 1370 patients were screened, with 177 eligible and 116 consented (mean [SD] age, 66.4 [9.6] years; 68 women [58.6%]). Of these 116 patients, 58 were randomized to the intervention and 58 to the control. A total of 103 patients (88.8%) completed assessments at 3 months, 95 (81.9%) at 6 months, and 95 (81.9%) at 12 months. There were no statistically significant differences between the intervention and control groups for self-reported physical function (EORTC QLQ-C30 physical functioning domain score) at the 3-month primary end point (mean [SD] score, 77.3 [20.9] vs 76.3 [18.8]; mean difference, 1.0 point [95% CI, -6.0 to 8.0 points]). Patients in the intervention group, compared with the control group, had significantly greater exercise capacity (6-minute walk distance: mean difference, 39.7 m [95% CI, 6.8-72.6 m]), global quality of life (mean difference, 7.1 points [95% CI, 0.4-13.8 points]), and exercise self-efficacy (mean difference, 16.0 points [95% CI, 7.0-24.9 points]) at 3 months as well as greater objectively measured physical function (Short Physical Performance Battery score: mean difference, 0.8 points [95% CI, 0.1-1.6 points]), exercise capacity (6-minute walk distance: mean difference, 50.9 m [95% CI, 6.7-95.1 m]), and exercise self-efficacy (mean difference, 10.1 points [95% CI, 1.9-18.2 points]) at 6 months. One minor adverse event and no serious adverse events occurred. In this randomized clinical trial, a postoperative home-based exercise and self-management program did not improve self-reported physical function in patients with lung cancer. However, it did improve other important clinical outcomes. Implementation of this program into lung cancer care should be considered. http://anzctr.org.au Identifier: ACTRN12617001283369.

Abstract 4143239: Extracorporeal Shockwave Therapy Improves Physical Outcomes and Quality of Life In Patients With Symptomatic Peripheral Arterial Disease: Results from a Meta-analysis of Randomized Controlled Trials

Introduction: Extracorporeal shockwave therapy (ESWT) is a non-invasive procedure that may be useful to treat symptomatic peripheral arterial disease (PAD). Trials comparing ESWT with control groups have shown promising results. Methods: PubMed, Cochrane, EMBASE, and Google Scholar were searched for randomized controlled trials reporting the efficacy of extracorporeal shockwave therapy versus control in patients with symptomatic PAD. Data from eligible studies was analyzed using the Review Manager 5.4 software. Mean difference (MD) and 95% Confidence intervals (CI) were calculated for continuous outcomes. Inverse variance method and a random effects model were used for pooled estimates. A p-value &lt; 0.05 (Z-test) was considered significant. Results: 5 randomized controlled trials with 264 patients were included in our analysis. A significant increase in the mean walking distance (MD: 54.13, 95% CI 9.34 to 98.92, p=0.02), pain-free walking distance (MD: 54.13, 95% CI 14.19, 57.88, p= 0.001), SF-36 physical component summary (MD: 11.97, 95% CI 0.26 to 23.69, p=0.05), EQ-5D-3L index score (MD; 0.08, 95% CI: 0.00 to 0.15, p=0.05) and VascuQoL index ((MD: 0.48, 95% CI 0.03 to 0.92, p= 0.04) was seen with ESWT. A slightly higher ankle brachial pressure index was seen in the control group (MD: -0.01, 95% CI: -0.02 to -0.00, p=0.04). There was no difference in SF-36 physical functioning domain score (MD: 18.58, 95% CI: -0.29 to 37.45, p=0.05) and SF-36 bodily pain score (MD: 9.17, 95% CI: -2.885 to 21.19, p=0.13). Conclusions: There was significant improvement in walking distances, exertional symptoms, and quality of life with ESWT. However, ESWT did not translate to an increase in post-treatment ankle-brachial index which was slightly higher in the control group. There is a need for larger randomized controlled trials to substantiate the efficacy of ESWT in treating symptomatic PAD.

Clinical Features of Conduction Block in Ulnar Neuropathy at the Elbow: The Surgery of the Ulnar Nerve (SUN) Multicenter Clinical Trial.

In ulnar neuropathy at the elbow, weakness is classically a sign of severe disease. Weakness is associated with motor axonal loss as measured by decreased distal compound muscle action potential (CMAP) amplitude. Conduction block, a demyelinating phenomenon that recovers readily, can also cause weakness, creating ambiguity for the treating clinician. This cross-sectional study evaluated baseline blinded data collected from 2020-2023 from the Surgery of the Ulnar Nerve randomized controlled trial comparing in-situ decompression versus transposition procedures. Adult patients underwent electrodiagnostic testing, clinical motor and sensory testing, and completed the Michigan Hand Questionnaire and Carpal Tunnel Questionnaire. 177 patients were categorized into 3 distinct groups based on normal distal CMAP amplitudes (77 patients), presence of conduction block with or without distal CMAP amplitude loss (37 patients), or pure axonal loss with distal CMAP amplitude loss in the absence of conduction block (63 patients). Compared to the normal group, patients with conduction block had significantly decreased pinch strength and worse function domain scores on the Michigan Hand Questionnaire and Carpal Tunnel Questionnaire, but shorter duration of disease. Patients with pure axonal loss had decreased pinch strength, worse 2-point discrimination, and worse overall, function and aesthetics domain scores on the Michigan Hand Questionnaire. There was a significant interaction between the effects of conduction block and distal CMAP amplitude on pinch strength, indicating that higher degrees of conduction block resulted in more pronounced loss of pinch strength in patients with relatively preserved distal CMAP amplitude. Our findings support the paradigm that ulnar neuropathy at the elbow presenting with conduction block represents a distinct and intermediate pathophysiology, distinguished by quicker onset with less advanced neurological deficits. Prognostic Level II.

Validation of the Integrated Palliative Care Outcome Scale (IPOS) in adults with cystic fibrosis.

A primary palliative care model for cystic fibrosis (CF) recommends using the Integrated Palliative Care Outcome Scale (IPOS) for screening. Validation of the IPOS is needed. This secondary analysis utilized baseline data from a multisite trial of the palliative care model, Improving Life with CF. Adults with CF completed the IPOS, the Memorial Symptom Assessment Scale-CF (MSAS-CF), the CF Questionnaire-Revised (CFQ-R), the Patient Health Questionnaire (PHQ-8), the Generalized Anxiety Disorder (GAD-7), and the Perceived Stress Scale (PSS). IPOS structure was assessed using Cronbach α coefficients and a factor analysis. Construct validity was evaluated through bivariate relationships between IPOS scores and other questionnaire scores, and linear regressions assessing the extent to which the IPOS explains variance in quality-of-life domains. The sample comprised 256 adults with complete IPOS data. α coefficients were .86 for the IPOS total score, .81 for the Physical Symptoms subscale, .79 for the Emotional Symptoms subscale, and .63 for the Communication/Practical Issues subscale. A two-component factor structure best aligned with the current subscales. IPOS scores were significantly associated with other measures; associations with MSAS-CF and CFQ-R subscales differentiated the IPOS Physical and Emotional subscales. The IPOS total score provided unique information about the variance in the CFQ-R Physical Functioning and Respiratory Symptoms domain scores. In adults with CF, the IPOS has acceptable internal consistency and there is evidence of construct validity. These findings support adoption of the IPOS in the primary palliative care model for CF.

The Intra-Meatal Application of Tadalafil Cream Versus Oral Administration Efficacy and Safety: Results from a Randomized, Two-Administration Route, Cross-Over Clinical Trial.

Background: Tadalafil cream, a topically administered phosphodiesterase-5 inhibitor (PDE5), presents a potential alternative to oral PDE5 inhibitors like tadalafil for the treatment of erectile dysfunction (ED). This study evaluates the non-inferiority and potential superiority of tadalafil cream compared to oral tadalafil. Methods: This randomized controlled trial employed a cross-over design with two treatment periods of two weeks each, separated by a one-week washout phase. Thirty-five male participants aged 18-75 with diagnosed ED (International Index of Erectile Function-Erectile function: IIEF-EF score < 26) were randomized to receive either tadalafil cream or oral tadalafil. Tadalafil cream was applied topically, while tadalafil was taken orally. The primary endpoint was IIEF-EF, and secondary endpoints were measured using the International Index of Erectile Function (IIEF) domain scores. Adverse events and treatment preferences were also assessed. Results: Tadalafil cream showed a higher increase in sexual function across all IIEF domains compared to oral tadalafil. The lower bounds of the confidence interval [improvement: final-baseline scores between tadalafil cream and oral tadalafil 0.72 (95% CI -2.72-4.15)] were above the non-inferiority margin of -3.22, confirming tadalafil cream's non-inferiority in the erectile function domain. In the intercourse satisfaction domain, tadalafil cream was superior to oral tadalafil. At the end of the trial, 88.57% of participants preferred tadalafil cream (95% CI 73.26%-96.79%), a result significantly above the non-inferiority margin that indicated superiority (p < 0.001). No systemic adverse events were reported for tadalafil cream, and significant differences in dizziness, headache, nasal congestion, and erythema were observed between the two treatments. Conclusions: Tadalafil cream is a safe and effective treatment for erectile dysfunction, demonstrating non-inferiority and potential superiority over oral tadalafil, with a high patient preference. Its topical administration offers a promising alternative for patients, particularly those with cardiovascular diseases where oral PDE5 inhibitors are contraindicated or less well tolerated.

Pain associated with prostaglandin E1-containing intracavernosal injection medication is associated with poor erectile function recovery after radical prostatectomy.

Intracavernosal injection therapy is often used as second-line therapy for erectile dysfunction associated with radical prostatectomy when therapy with phosphodiesterase-5 inhibitors has failed, but prostaglandin E1-containing vasoactive agents are associated with penile pain in some men. To define the incidence of pain with prostaglandin E1-containing intracavernosal injectionmixtures for erectile dysfunction associated with radical prostatectomy when therapy with phosphodiesterase-5 inhibitors has failed, and whether painwasa predictor of erectile function recovery. Men who underwent radical prostatectomy andwerecommencedonintracavernosal injection within 12 months of radical prostatectomy were included. A pain visual analog scale (0-10) was used to assess the degree of pain. Erectile function recovery was defined asthe International Index of Erectile Function domain score ≥24using phosphodiesterase-5 inhibitors at 24months. The study included 566 patients, mean age was 58±14 (42-74) years. Duration post-radical prostatectomy at intracavernosal injection training was 3.5±3.5m. Nerve sparing status: bilateral 76%, unilateral 13%, and non-nerve sparing 11%. Incidence of pain with intracavernosal injection per nerve sparing status: bilateral 10% of patients, unilateral 32%, non-nerve sparing 92% (p<0.001). Median visual analog scale in those experiencing pain: bilateral 4 (interquartile range 3, 5), unilateral 5.5 (interquartile range 3, 6), non-nerve sparing 7 (interquartile range 3, 9) (p<0.001). Phosphodiesterase-5 inhibitors success at 24months (no pain vs. pain): bilateral 70%vs. 40% (p<0.001), unilateral 50%vs. 28% (p<0.001), non-nerve sparing 10%vs. 0% (p<0.001). On multivariate analysis, predictors of failure to respond to phosphodiesterase-5 inhibitors at 24months post-radical prostatectomy included baseline erectile function, increasing age, incomplete nerve-sparing surgery, and presence of pain. The presence of penile pain with intracavernosal injection is associated with poorer erectile function recovery post-radical prostatectomy. Incidence of pain is high in men with non-nerve sparing radical prostatectomy; older patient age, poorer nerve sparing, poor baseline erectile function, and the presence of penile pain with prostaglandin E1-containing intracavernosal injection medication, were predictive of poor erectile function recovery using phosphodiesterase-5 inhibitors at 24months.

Association of physical function with masticatory ability and masticatory habits: a cohort study

BackgroundFew studies have evaluated masticatory ability and habits in relation to physical function. This study aimed to investigate the association of physical function with both masticatory ability and masticatory habits.MethodsIn this cohort study, we followed up with 146 community-dwelling older adults aged 65–84 years for 1 year. Physical function domain scores on the Kihon Checklist were used to assess physical function. Masticatory ability was examined using objective measurements and self-administered questionnaires. Data on masticatory habits were obtained using self-administered questionnaires. The Mann–Whitney U test was used to analyze the association between masticatory ability and masticatory habits as exposures; logistic regression analysis was used to analyze the effect of exposure on the outcome.ResultsA relationship was found between objective and subjective masticatory ability; however, no relationship was found between objective masticatory ability and masticatory habits. Furthermore, subjective masticatory ability and masticatory habits appeared to influence physical function 1 year later (odds ratio [OR]: 6.00, 95% confidence interval [CI]: 1.44–25.05; OR: 6.49, 95% CI: 2.45–17.22).ConclusionMasticatory ability and habits may be associated with a decline in physical function after 1 year in community-dwelling older adults. To maintain the physical function of these individuals, early intervention that addresses not only masticatory ability but also masticatory habits is necessary.Graphical

Effect of multidisciplinary team-style continuity of care and nutritional nursing on lung cancer: randomized study.

Aim: The clinical efficacy of systemic chemotherapy is limited due to the nonspecific delivery of anticancer drugs and is associated with serious systemic adverse effects. Therefore, integrated treatment and comprehensive care are particularly important for postoperative chemotherapy patients with lung cancer.Materials & methods: This study aimed to ascertain the application effect of multidisciplinary team (MDT)-style continuity of care combined with whole-process nutritional nursing in postoperative chemotherapy patients with lung cancer. Nutritional indices, immune function, adverse emotions, self-efficacy, self-care ability, quality of life and toxic reactions during chemotherapy were recorded in postoperative chemotherapy patients with lung cancer receiving routine care (control group) and MDT-style continuity of care combined with whole-process nutritional care (intervention group).Results: After care, the intervention group performed higher BMI, PA, TP and ALB, CD3+, CD4+ and CD4+/CD8+, lower levels of CD8+, lower self-rating anxiety scale, self-rating depression scale and QLQ-C30 symptom domain scores and higher general self-efficacy scale, exercise of self-care agency scale and QLQ-C30 functional domain scores versus the control group (all p<0.05).Conclusion: MDT-style continuity of care combined with whole-process nutritional care can improve the nutritional status of postoperative chemotherapy patients with lung cancer, and in turn enhance their quality of life.

Immediate Versus Delayed Exercise on Health-related Quality of Life in Patients Initiating Androgen Deprivation Therapy: Results from a Year-long Randomised Trial

Background and objectiveAn array of treatment-related toxicities result from androgen deprivation therapy (ADT) in patients with prostate cancer (PCa), compromising function and health-related quality of life (HRQoL). Exercise has been demonstrated to counter a number of these adverse effects including decreased HRQoL; however, when exercise should be initiated is less clear. This study aims to examine whether commencing exercise when ADT is initiated rather than later during treatment is more effective in countering adverse effects on HRQoL. MethodsMen with PCa (48–84 yr) initiating ADT were randomised to immediate exercise (IMEX; n = 54) or delayed exercise (DEL; n = 48) for 12 mo. IMEX consisted of 6 mo of supervised resistance/aerobic/impact exercise commenced at the initiation of ADT with 6 mo of follow-up. DEL consisted of 6 mo of usual care followed by 6 mo of the same exercise programme. HRQoL was assessed using the Short Form-36 at baseline and 6 and 12 mo. Intention to treat was utilised for the analyses that included group × time repeated-measures analysis of variance using log transformed data. Key findings and limitationsThere were a significant group × time interaction for the physical functioning domain (p = 0.045) and physical component summary score (p = 0.005), and a significant time effect for bodily pain (p < 0.001) and vitality domains (p < 0.001), with HRQoL maintained in IMEX and declining in DEL at 6 mo. Exercise in DEL reversed declines in vitality and in the physical component summary score, with no differences at 12 mo compared with baseline. Limitations include treatment alterations during the intervention. Conclusions and clinical implicationsConcurrently initiating exercise and ADT in patients with PCa preserves HRQoL, whereas exercise initiated while on established ADT regimens reverses declines in some HRQoL domains. Patient summaryTo avoid initial treatment-related adverse effects on health-related quality of life, exercise medicine should be initiated at the start of treatment.

Efficacy and safety of low-intensity pulsed ultrasound (LIPUS) combined with tadalafil in the treatment of severe erectile dysfunction: a retrospective cohort study.

Low-intensity pulsed ultrasound (LIPUS) is an effective and safe treatment for mild to moderate erectile dysfunction (ED). This study aimed to investigate the efficacy and safety of combining LIPUS with tadalafil in treating severe ED. The data from 27 patients treated with LIPUS alone (group A) and 21 patients treated with a combination of LIPUS and daily 10 mg tadalafil (group B) were retrospectively analyzed. The LIPUS regimen consisted of twice-weekly treatments for 4 consecutive weeks. The treatment was considered effective if the change in International Index of Erectile Function-Erectile Function Domain (IIEF-EF) score after treatment was greater than or equal to the minimal clinically important difference (MCID) (the MCID for severe ED is 7 points). The effectiveness, IIEF-EF score, erectile hardness score (EHS), peak systolic velocity (PSV), end diastolic velocity (EDV), and adverse events were evaluated before treatment, 4 weeks after treatment, and 12 weeks after treatment. Compared to pre-treatment, both groups showed significant improvement in IIEF-EF score and EHS at 4 and 12 weeks after treatment (P<0.001), with no statistically significant difference between the two time points (P>0.05). The effective rate did not significantly differ between group A (9/27, 33.3%) and group B (10/21, 47.62%) at 4 weeks or between group A (9/27, 33.3%) and group B (12/21, 57.14%) at 12 weeks after treatment (P=0.32, P=0.10). However, in patients without comorbidities, the effective rate of group B (12/18, 66.67%) was higher than that of group A (9/25, 36.00%) at 12 weeks after treatment (P=0.047). After LIPUS treatment, the PSV level significantly increased and the EDV level significantly decreased compared with before treatment (P<0.05). No adverse events were reported. The study suggests that LIPUS has a therapeutic effect on severe ED patients, especially those without comorbidities. It may have a synergistic or overlapping effect with phosphodiesterase type 5 inhibitors (PDE5Is) on severe ED patients without comorbidities.

(146) TOPICAL ADMINISTRATION OF MED3000 GEL SIGNIFICANTLY IMPROVES ERECTILE FUNCTION IN MEN WITH MILD, MODERATE, OR SEVERE ERECTILE DYSFUNCTION: RESULTS FROM TWO MULTICENTER CLINICAL TRIALS

Abstract Introduction MED3000 is an FDA-cleared, over-the-counter topical erectile dysfunction (ED) treatment. As MED3000 can be accessed by a mixed group of men with varying levels of ED severity, it is important to assess efficacy in these subgroups. Objective To assess the effects of MED3000 in men with mild, moderate, and severe ED using the International Index of Erectile Function – Erectile Function (IIEF-EF) domain score (assessed on both controlled trials for this treatment and Sexual Encounter Profile (SEP) Questions (Q) 2 and 3 (evaluated in one study). Methods Two multicenter clinical trials enrolled men with a diagnosis of ED for &amp;gt;3 months according to the NIH Consensus Statement. ED severity was defined by baseline IIEF-EF domain scores (mild = 17 or greater, moderate = 11-16, and severe = 10). Study 1 lasted 12 weeks and study 2 was of 24-week duration. Patients or their female partners were instructed to apply MED3000 immediately prior to sexual intercourse and they were required to make at least 4 intercourse attempts in each of the 4-weekly periods during treatment. Subjects in both studies were instructed to complete the IIEF-EF at the end of each 4-week treatment period and those in Study 1 were also instructed to answer SEP Q2 and Q3 after each intercourse attempt. The changes from baseline for the IIEF-EF domain changes from baseline for each 4-week interval were averaged to provide a mean change from baseline over 12 (Study 1) or 24 weeks (Study 2). The changes from baseline for percentages of patients responding “Yes” to SEP Q2 or Q3 were averaged to provide a mean change from baseline over the 12- and 24-week study periods (average of non-missing data from each 4-weekly visit). The significance of changes from baseline for all measures were determined with paired t-tests. With Bonferroni correction, P &amp;lt; 0.004 was the accepted value for statistical significance for Study 1 and P &amp;lt; 0.0125 was accepted for Study 2. Efficacy analyses were conducted using all subjects who made use of the treatment at least once and missing data were imputed. Results Study 1 enrolled 250 subjects (mean age ± standard deviation (SD) = 46.8 ± 12.5 years, duration of ED = 27.5 ± 36.5 months, 59.2%, 28.0%, and 12.8% with mild, moderate, or severe ED, respectively). Study 2 enrolled 48 subjects (44 White, 4 Black, mean age = 46.1 ± 13.5 years, duration of ED = 28.9 ± 32.3 months, 39.6%, 35.4%, and 25.0% with mild, moderate, or severe ED). MED3000 treatment resulted in significant improvements from baseline in the IIEF-EF domain scores over 12 or 24 weeks in total cohorts and those with mild, moderate or severe ED (Table 1). Changes from baseline for IIEF-EF scores in both studies exceeded the minimal clinically important differences (MCID) for mild (2 points), moderate (5 points), and severe (7 points) ED. Results from Study 1 indicated significant improvements from baseline for SEP Q2 and Q3 that also exceeded the MCIDs for these measures for all ED severities. Conclusions Results from these studies of MED3000 demonstrated statistically and clinically significant improvements from baseline for IIEF-EF domain scores (both studies) and SEP Q2 and Q3 (Study 1 only), measures commonly employed to assess treatment-related improvements in erectile function, in patients with mild, moderate or severe ED. Disclosure Yes, this is sponsored by industry/sponsor: Haleon. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Haleon.

Does Diabetes Have a Negative Impact on Erectile Function Recovery After Radical Prostatectomy?

ObjectivesTo quantify the risk of long-term post-radical prostatectomy (RP) erectile dysfunction (ED) in men with diabetes mellitus (DM). MethodsWe included men who underwent RP and were followed for ≥ 24 months at our institution; men were excluded if they received androgen deprivation therapy or radiation therapy. Erectile function recovery (EFR) was assessed using the International Index of Erectile Function (IIEF) Erectile Function Domain (EFD) score pre-RP and serially during follow-up. We performed logistic regression analysis to investigate a potential association between erectile function 24 months post- RP. ResultsOf 2,261 men included. 8% were diabetic. Men in the diabetic group tended to present with more vascular comorbidities. For men with DM, the median time from diagnosis was 4 years pre-RP, and the median hemoglobin A1c pre-RP was 6.7%. After 24 months post-RP, EFR was significantly lower among the diabetic group. The median EFD was 7. Men with DM had a lower proportion of functional EFR (17%) and a greater proportion of severe ED (57%). In the univariable logistic regression model to analyze DM diagnosis was a significant predictor of functional EFR (OR 0.43, p<0.001) and severe ED (OR 1.85, p<0.001) 24 months post-RP. Furthermore, this was not observed for a multivariable analysis. Conclusions24 months after RP, EFR is compromised in individuals with DM

Disability in migraine: Multicountry results from the Chronic Migraine Epidemiology and Outcomes - International (CaMEO-I) Study.

Few studies of migraine have evaluated migraine disability across multiple countries using the same methodology. This cross-sectional, web-based survey was conducted in 2021-2022 in Canada, France, Germany, Japan, UK and USA. Respondents with migraine were identified based on modified International Classification of Headache Disorders, 3rd edition, criteria. Headache features (Migraine Symptom Severity Score (MSSS, range: 0-21), presence of allodynia (Allodynia Symptom Checklist, ASC-12)) and migraine burden (Patient Health Questionnaire-4 (PHQ-4), Migraine-Specific Quality of Life questionnaire version 2.1 (MSQ v2.1), Work Productivity and Activity Impairment (WPAI) questionnaire) were evaluated. Among 14,492 respondents with migraine across countries, the mean ± SD MSSS was 15.4 ± 3.2 and 48.5% (7026/14,492) of respondents had allodynia based on ASC-12. Of all respondents living with migraine, 35.5% (5146/14,492) reported moderate to severe anxiety and/or depression symptoms. Mean ± SD MSQ v2.1 Role Function-Restrictive, Role Function-Preventive and Emotional Function domain scores were 60.7 ± 22.9, 71.5 ± 23.0 and 65.1 ± 27.2, respectively. The WPAI mean ± SD percentages of respondents who missed work or worked impaired as a result of migraine were 6.8 ± 18.1% and 41.0 ± 30.1%, respectively. For every country surveyed, migraine was associated with high levels of symptom severity, with allodynia and with substantial burden.

Evaluation of intra cavernosal platelet-rich plasma injection as a new treatment of erectile dysfunction

ABSTRACT Aim of the Work Aim of the work is to evaluate the effect of intracavernosal injection of platelet-rich plasma (PRP) for the treatment of arteriogenic erectile dysfunction (ED). Methods This study was conducted up on 25 men complaining of mild-to-moderate ED, who were in a stable relationship for more than 1 year. Results After 6 months of intracavernosal PRP injection, there was a statistically significant improvement of the International Index of Erectile Function-Erectile Function domain score, which then declines after 1 year of the treatment. No adverse effects were observed during the study. Conclusions PRP intracavernosal injections may be a promising option for the management of arteriogenic ED. But further studies are needed to confirm these findings.

Surgical and Patient-Reported Outcomes After Mastectomy and Implant-Based Prepectoral Reconstruction Using TIGR® Synthetic Mesh.

Background Single-stage direct-to-implant (DTI) breast reconstruction after mastectomy has gained popularity over the last decade, thanks to the wide use of biological matrices and synthetic meshes. Despite their high cost, there is no evidence of superior outcome from the biological matrices compared to the synthetic meshes. In this study, we aimed to evaluate our experience with TIGR, a synthetic, long-term absorbable mesh, in mastectomy and immediate breast reconstruction (MIBR) with a focus on patient-reported outcomes (PROMs). Methods This was a single-trust prospective quality improvement study conducted between 2017 and 2019. The main objectives were complication rates including infection, implant loss, and other surgical complications in patients undergoing TIGR mesh-assisted MIBR in the prepectoral plane for either cancer or risk reduction. PROMs were measured using the validated European Organisation for Research and Treatment of Cancer (EORTC) breast questionnaire module. Clinical evaluations were conducted at one week, three weeks, and 12 months postoperatively. All patients provided written consent, and the audit was registered with the Quality Improvement Department of the organization. Results One hundred and twelve meshes were used in 93 patients with a mean age of 49 (24-75) years and a body mass index (BMI) of 23.4 (19.1-29.6). During the follow-up period, complications occurred in 26 patients (28%), including infection in four (4.3%), complete skin flap necrosis in one (1%), partial flap necrosis in three (3.2%), and implant loss in four (4.3%) patients. PROM data from 41 individuals indicated a moderate overall quality of life (82.7%), with high functional domain scores with relatively lower emotional functioning scores. Symptom domains generally scored poorly except for body image and sexual functioning. Conclusion Mastectomy and immediate prepectoral breast reconstruction using TIGR mesh is safe with low major complication rates. It is associated with high functional and quality of life scores but low scores in symptom domains which could be multifactorial. However, limitations due to study type and follow-up duration suggest caution in generalizing findings.

Assessing the impact of early progressive mobilization on moderate-to-severe traumatic brain injury: a randomized controlled trial.

Traumatic brain injury (TBI) is a major cause of neurodisability worldwide, with notably high disability rates among moderately severe TBI cases. Extensive previous research emphasizes the critical need for early initiation of rehabilitation interventions for these cases. However, the optimal timing and methodology of early mobilization in TBI remain to be conclusively determined. Therefore, we explored the impact of early progressive mobilization (EPM) protocols on the functional outcomes of ICU-admitted patients with moderate to severe TBI. This randomized controlled trial was conducted at a trauma ICU of a medical center; 65 patients were randomly assigned to either the EPM group or the early progressive upright positioning (EPUP) group. The EPM group received early out-of-bed mobilization therapy within seven days after injury, while the EPUP group underwent early in-bed upright position rehabilitation. The primary outcome was the Perme ICU Mobility Score and secondary outcomes included Functional Independence Measure motor domain (FIM-motor) score, phase angle (PhA), skeletal muscle index (SMI), the length of stay in the intensive care unit (ICU), and duration of ventilation. Among 65 randomized patients, 33 were assigned to EPM and 32 to EPUP group. The EPM group significantly outperformed the EPUP group in the Perme ICU Mobility and FIM-motor scores, with a notably shorter ICU stay by 5.9days (p < 0.001) and ventilation duration by 6.7days (p = 0.001). However, no significant differences were observed in PhAs. The early progressive out-of-bed mobilization protocol can enhance mobility and functional outcomes and shorten ICU stay and ventilation duration of patients with moderate-to-severe TBI. Our study's results support further investigation of EPM through larger, randomized clinical trials. Clinical trial registration ClinicalTrials.gov NCT04810273 . Registered 13 March 2021.

Abstract PS02-02: Patient-reported outcomes from the Phase 3 CAPItello-291 trial investigating capivasertib and fulvestrant for patients with aromatase inhibitor-resistant HR-positive/HER2-negative advanced breast cancer

Abstract Background: In the Phase 3 CAPItello-291 trial, adding capivasertib (C), a pan-AKT inhibitor, to fulvestrant (F) in patients (pts) with aromatase inhibitor-resistant, HR+/HER2− (HER2− defined as IHC 0, or 1+ or IHC2+/ISH–) advanced breast cancer significantly improved PFS vs placebo (P) + F in the overall (HR 0.60, 95% CI 0.51, 0.71, p&amp;lt; 0.001) and AKT pathway-altered populations (HR 0.50, 95% CI 0.38, 0.65, p&amp;lt; 0.001). The safety profile of C-F was manageable; diarrhea (mostly grade 1) was the most frequent adverse event. Global health status (GHS)/health-related quality of life (HRQoL) was maintained from baseline in both arms; time to deterioration (TTD) favored C-F. We report results from additional patient-reported outcomes (PRO). Methods: Pts were randomized 1:1 to receive F (500 mg IM on days 1 and 15 of cycle 1 and day 1 of each subsequent 28-day cycle) with either P or C (400 mg BID; 4 days on, 3 days off). PRO measures assessed HRQoL, disease-related symptoms, functioning, and patient-reported treatment tolerability using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), EORTC QLQ Breast Cancer 23 items (EORTC QLQ-BR23), PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and Patient Global Impression of Treatment Tolerability (PGI-TT). PROs were assessed at pre-specified timepoints. Change from baseline was assessed using Mixed Model Repeat Measures (on-treatment scores) for EORTC QLQ-C30 and summarized for EORTC QLQ-BR23; TTD was assessed using the stratified log-rank test for both. Results: Overall, 708 pts were randomized to C-F (n=355) or P-F (n=353). Overall compliance rates with EORTC QLQ-C30 and PGI-TT were 84.5% and 80.6% with C-F and 81.8% and 81.7% with P-F, respectively. Baseline compliance rates with the EORTC QLQ-C30 and PGI-TT were 88.2% and 82.8% with C-F and 87.3% and 83.1% with P-F, respectively. Mean changes from baseline in EORTC QLQ-C30 functional and symptom domain scores were maintained with C-F and P-F, except for diarrhea in the C-F arm, where scores worsened by &amp;gt;10 points (table). TTD analysis showed that HRs favored C-F vs P-F for all functional and symptom domains, except diarrhea (HR 2.75; 95% CI 2.01, 3.81), which favored P-F (table). Median TTD of diarrhea was shorter with C-F vs P-F in line with the C-F safety profile. Diarrhea with C-F was generally manageable, and discontinuations due to diarrhea were low (2.0%; n=7/355). For PGI-TT, most pts reported that they were ‘not at all’ or ‘a little bit’ bothered by the side effects of cancer therapy. Over the first 6 months, the proportion of pts reporting to be ‘somewhat’, ‘quite a bit’, or ‘very much’ bothered by side effects was higher for C-F vs P-F, with between-arm differences being highest in the first 2 cycles. Results from EORTC QLQ-BR23 domains will be presented at the meeting. Conclusions: Pts treated with C-F maintained HRQoL for longer than pts treated with P-F on all EORTC QLQ-C30 functional and symptom domain scores, except diarrhea. Worsening of diarrhea was observed with C-F, consistent with the safety profile of C, but events appeared tolerable and did not negatively impact GHS/HRQoL. Together with the clinical efficacy and manageable safety profile of C-F, the PRO results from the CAPItello-291 trial further support a positive benefit–risk profile of the combination in this population. https://clinicaltrials.gov/: NCT04305496. Funding: CAPItello-291 is sponsored by AstraZeneca. Editorial acknowledgment: AstraZeneca-funded medical writing support was provided by Suzanne Patel, Ph.D., from BOLDSCIENCE Inc. Capivasertib was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited). Citation Format: Hope Rugo, Mafalda Oliveira, Sacha Howell, Florence Dalenc, Javier Cortés, Henry Gómez, Xichun Hu, Komal Jhaveri, Petr Krivorotko, Sibylle Loibl, Serafin Morales Murillo, Meena Okera, Yeon Park, Joo Hyuk Sohn, Eriko Tokunaga, Masakazu Toi, Samih Yousef, Lyudmila Zhukova, Marta Fulford, Haylee Andrews, Ian Wadsworth, Celina D’Cruz, Nicholas Turner. Patient-reported outcomes from the Phase 3 CAPItello-291 trial investigating capivasertib and fulvestrant for patients with aromatase inhibitor-resistant HR-positive/HER2-negative advanced breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS02-02.

The Impact of Frailty on Surgical Outcome of Patients with Lumbar Spinal Canal Stenosis.

Frailty is an important factor in surgical outcomes. The current study aimed to evaluate the effect of preoperative frailty on postoperative outcomes in older patients with lumbar spinal canal stenosis (LSCS). We retrospectively examined 209 patients aged ≥65 years who underwent surgery for LSCS. Health-related quality-of-life (HRQOL) tools, including the Roland-Morris Disability Questionnaire (RDQ), Zurich Claudication Questionnaire (ZCQ), and Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ), were used in the assessment conducted before surgery and at 6 months and 1 year after surgery. Frailty was categorized based on the 11-item modified frailty index (mFI-11). Patients with mFI-11 of 0, <0.21, and >0.21 were classified under the robust (R), pre-frailty (P), and frailty (F) groups, respectively. According to the mFI-11, 24, 138, and 47 patients were included in the R, P, and F groups, respectively. Regarding preoperative radiographic parameters, there was a remarkable increase in the sagittal vertical axis and a significant decrease in the development of lumbar lordosis with frailty progression. The preoperative scores of RDQ and ZCQ, and lumbar function, walking ability, social life, and psychological disorder domain scores of JOABPEQ differed significantly among these groups. The frequency of revision surgery was not higher in the F group than in the other groups. After adjustment for factors have shown different distributions among the three groups, the frequency of effective surgical cases did not show a clear trend among the three groups in all domains of the JOABPEQ. The preoperative HRQOL scores and the radiographic parameters of patients with LSCS worsened with frailty severity. However, frailty did not affect the rate of revision surgery and surgical efficacy in patients with LSCS. Although this study has limitations, our findings indicated that even LSCS patients with frailty can be considered for surgery if they have an indication for LSCS surgery.