Baseline Scores Research Articles

Evaluación de los cambios en la función sexual en pacientes sometidos a cirugía endoscópica de la litiasis del tracto urinario superior

ObjectiveTo evaluate the effect of endoscopic surgery on sexual function in patients with upper urinary tract (UUT) lithiasis. Material and methodsWe conducted an observational, prospective, longitudinal study with a single cohort of cases undergoing ureteroscopy (URS), retrograde intrarenal surgery (RIRS), or endoscopic combined intrarenal surgery (ECIRS). Patients’ sexual response was assessed with questionnaires in the 30 days prior to surgery, and at one and three months after surgery. The International Index of Erectile Function (IIEF-t) was used in male patients, and the Female Sexual Function Index (FSFI) was used in female patients. ResultsSeventy patients -34 men and 36 women- completed the study. Among men, the IIEF-t did not show significant difference between baseline scores (64.1±7.50) and those obtained at 3 months (63.8±9.51), with a non-significant decrease (p=0.054) at the first month (61.4±10.4). Subdomains did not worsen at 3 months, and desire (IIEF-SD) improved from 7.3±1.9 to 8.0±1.8. Among women, the FSFI-t did not change significantly after surgery: baseline score (27.3±4.1), 1-month score (26.8±3.7) and 3-month score (27.5±4.2). No subdomain worsened at the third month. ConclusionEndoscopic surgery for UUT is a safe technique in both sexes with no negative effect on sexual function. There are no differences between the baseline IIEF-t and FSFI-t scores and those obtained at 3 months.

Autograft and Allograft Anterior Cruciate Ligament Reconstruction in Patients Older Than 40 Years Have Similar Short-Term Patient-Reported Outcomes With Greater Rates of Anterior Cruciate Ligament Graft Failure in Patients Who Receive Allograft

PurposeThe purpose of this study was to evaluate short-term patient-reported outcomes (PROs) in patients aged 40 and older after primary ACLR between patients that received allograft or autograft. Secondary aims included assessing the effect of pre-existing osteoarthritis on short-term PROs. MethodsA retrospective review of an ambulatory surgery center’s electronic medical record was conducted for patients who underwent primary ACLR between 2009 and 2022. Patients aged younger than 40, those who underwent index revision procedures and/or concomitant ligament repair/reconstructions, and those with incomplete baseline or short-term (1- or 2-year) KOOS scores were excluded. Allograft and autograft patients were matched according to sex and body mass index (BMI) in a 2:1 fashion. PROs used included KOOS and Single Assessment Numeric Evaluation (SANE) at baseline and short-term follow up (minimum of 1 year). Minimum clinically important difference was calculated in a distribution-based fashion. Osteoarthritis severity was determined based on Kellgren-Lawrence grading of perioperative knee x-rays. Preexisting osteoarthritis was defined as KL grade 1 or more. ResultsA total of 331 patients were included after matching (215 allograft and 116 autograft patients). The average age was 47.7 ± 6.0 (range: 40-66). Age differed significantly between the two groups, with the allograft cohort having an average age of 48.6 ± 6.0 years and the autograft cohort having an average age of 46.1 ± 5.7 years (p < 0.001). Short-term change in KOOS and SANE scores did not differ by graft type (p = 0.154, p = 0.556, respectively). Sixty-seven percent of all patients met MCID for KOOS and 82% of patients with complete baseline and short-term SANE scores met MCID for SANE. There was a statistically significant difference in rupture rates between the allograft and autograft cohorts (n = 9 allograft vs n = 0 autograft; p = 0.030). There was no difference in re-operation rates between the autograft and allograft cohorts (p = 0.453). Perioperative Kellgren-Lawrence grading did not affect outcomes for either graft type (allograft: p = 0.905 vs. autograft: p = 0.522). ConclusionMiddle-aged patients undergoing ACLR with allograft or autograft demonstrate similar short-term patient reported outcomes. Pre-existing osteoarthritis similarly did not significantly affect short-term outcomes. However, rerupture rates were significantly higher in the allograft cohort than the autograft cohort. Level of EvidenceLevel III - Therapeutic

Abstract P344: APOe Genotype Modifies the Association Between Long-Term Blood Pressure Variability and Cognitive Decline/Dementia in Older Adults

We previously reported an increased risk of cognitive decline and dementia with high visit-to-visit long-term blood pressure variability (BPV) in the ASPREE randomized trial of low-dose aspirin, conducted in 19,114 community-dwelling older adults in Australia and the USA who were initially free of significant cognitive impairment and diagnosed dementia at enrollment. Upon completion of the randomized trial phase, ASPREE participants were invited into the ASPREE-eXTension (ASPREE-XT) observational study. In this analysis, we re-examined the risks of cognitive decline and dementia using extended follow-up from ASPREE-XT, and including recently available APOe genotype as an additional covariate. Long-term BPV was estimated in each participant using standard deviation (SD) of the means of three within-visit systolic BPs obtained with a validated automated oscillometric BP monitor from the baseline and first two annual ASPREE visits. During ASPREE and continued into ASPREE-XT, participants underwent annual/biennial standardized cognitive testing (4-test battery). Incident cognitive decline was defined as &gt;1.5 SD decline from baseline score on any cognitive test; incident dementia was a pre-specified secondary endpoint of ASPREE/ASPREE-XT and adjudicated by expert panel using DSM-IV criteria and clinical records. Participants reaching cognitive decline or dementia endpoints during the BPV estimation period were excluded from the analysis. Multivariable Cox proportional hazards regression showed the highest SD tertile of BPV, compared to the lowest SD tertile, remained associated with highest risk of cognitive decline (HR=1.16, 95% CI=1.04-1.30) and dementia (HR=1.27 (95% CI=1.02-1.59) in men, and cognitive decline (HR=1.12, 95% CI=1.01-1.24) in women (see accompanying Table), over a median follow-up of 5.8 years (for cognitive decline) and 6.5 years (for dementia). When APOe genotype was included as an additional covariate in an available subset of the cohort (81%), the presence of APOe4 allele partially attenuated the associations in both sexes, although cognitive decline remained significant in men. Our findings suggest the relationship between high long-term BPV and cognitive decline and dementia is stronger in men than women, but also modified by underlying APOe genotype.

Adherence to the Mediterranean Diet: A Tool to the Therapeutic Approaches for Patients With Temporomandibular Joint Disorders.

Temporomandibular joint disorder (TMD) is characterized by symptoms such as clenching, clicking, and locking of the jaw, often due to improper positioning affecting occlusion. Nearly half of TMD patients rarely require treatment, as symptoms typically diminish on their own within a year.Nevertheless, a significant majority of persons who are diagnosed with TMD do necessitate therapy, and it may take up to three years for complete remission to occur. This study aims to determine the extent to which a healthy nutritional model, specifically the Mediterranean diet, can enhance the effectiveness of existing therapeutic treatments, like physiotherapy with warm pads. An interventional study design was implemented. Baseline scores were obtained pre- and post-intervention, while Mediterranean diet adherence was evaluated once at the beginning. A dependent samples t-test and a one-way multivariate analysis of covariance (MANCOVA) were used to test the experimental hypotheses. There is a statistically significant difference (p=0.04) between the three groups associated with Mediterranean diet adherence, as indicated by the mean differences on the Jaw Functional Limitation Scale (JFLS-20) questionnaire. Participants following a medium or high level of Mediterranean diet (≥18) reported fewer problems with jaw functionality both before and after the intervention compared to those with low (<18) adherence to the diet. Adherence to the Mediterranean diet appears to have a therapeutic effect on patients with TMD, offering a new dimension to their treatment. The primary benefit is the low cost of treatment, as the diet is easily accessible. This dietary approach could significantly enhance the management of TMD symptoms.

The effect of socioeconomic status on clinical outcomes and implant survivorship after primary anatomic and reverse total shoulder arthroplasty

BackgroundLow socioeconomic status has been shown to contribute to poor outcomes in patients undergoing joint replacement surgery. However, there is a paucity of studies investigating shoulder arthroplasty. The purpose of this study was to evaluate the effect of socioeconomic status on baseline and postoperative outcome scores and implant survivorship after anatomic and reverse primary total shoulder arthroplasty (TSA). MethodsA retrospective review of a prospectively-collected single-institution database was performed to identify patients who underwent primary TSA. Zip codes were collected and converted to Area Deprivation Index (ADI) scores. We performed a correlation analysis between national ADI scores and preoperative, postoperative, and pre- to postoperative improvement in range of motion, shoulder strength, and functional outcome scores in patients with minimum 2-year follow-up. Patients were additionally grouped into groups according to their national ADI. Achievement of the MCID, SCB, and PASS and revision-free survivorship were compared between groups. ResultsA total of 1,148 procedures including 415 anatomic and 733 reverse total shoulder arthroplasties with a mean age of 64 ± 8.2 and 69.9 ± 8.0 years, respectively, were included. The mean follow-up was 6.3 ± 3.6 years for anatomic and 4.9 ± 2.7 years for reverse TSA. We identified a weak negative correlation between national ADI and most functional outcome scores and range of motion preoperatively (R range 0.07 to 0.16), postoperatively (R range 0.09 to 0.14), and pre- to postoperative improvement (R range 0.01 to 0.17). Thus, greater area deprivation was weakly associated with poorer function preoperatively, poorer final outcomes and poorer improvement in outcomes. There was no difference in the proportion of each ADI group achieving MCID, SCB, and PASS in the anatomic TSA cohort. However, in the reverse TSA cohort, the proportion of patients achieving MCID, SCB, and PASS decreased with greater deprivation. There was no difference in survivorship between ADI groups . ConclusionsWe found a negative effect of low socioeconomic status on baseline and postoperative patient outcomes and range-of-motion; however, the correlations were relatively weak. Patients that reside in socioeconomically deprived areas have poorer functional outcomes before and after TSA and achieve less improvement from surgery. We should strive to identify modifiable factors to improve the success of TSA in socioeconomically deprived areas.

Improving Critical Thinking in New Graduate Nurses Through the Use of Reflective Journaling: A Quality Improvement Project

BackgroundCritical thinking is an important skill for newly graduated nurses to develop to learn how to best recognize and manage deterioration in their patients. New nurses may be too focused on nursing tasks and may not have adequate time to pause and reflect on their patient experiences that foster critical thinking. An exercise like reflective journaling may help new graduate nurses engage in active reflection with the goal of learning from their experiences, which may enhance the development of critical thinking. PurposeThe purpose of this paper is to explore whether the use of a once weekly reflective journaling exercise influences the development of critical thinking in new graduate nurses during their 6-week nursing orientation. MethodsA quality improvement (QI), pre- and post-test design was used to improve the current process of nursing orientation for newly graduated nurses in a single hospital setting. Six participants participated in a once weekly reflective journaling intervention, utilizing Kim's Critical Reflective Inquiry, over a 6-week orientation period. Participants completed the Health Sciences Reasoning Test (HSRT) before reflective journaling was implemented and at the end of their 6-week hospital orientation. Preliminary ResultsPreliminary results found that there were no significant mean differences in the total HSRT scores after the reflective journaling was implemented (t = 1.085, p = .328). However, there was a strong, positive, and significant correlation between participants’ baseline and post reflective journaling critical thinking scores in the deduction domain (r =.810, p = 0.051). Clinically significant differences in the pre- and post-test domain scores of the HSRT were evident in the interpretation, inference, explanation, induction, and numeracy domains. ConclusionNew graduated nurses may benefit from using reflective journaling into their hospital orientation, but more research is needed to determine efficacy.

Effect of Aficamten on Health Status Outcomes in Obstructive Hypertrophic Cardiomyopathy: Results From SEQUOIA-HCM

BackgroundA primary goal in treating obstructive hypertrophic cardiomyopathy (oHCM) is to improve patients’ health status: their symptoms, function, and quality of life. The health status benefits of aficamten, a novel cardiac myosin inhibitor, have not been comprehensively described. ObjectivesThis study sought to determine the effect of aficamten on patient-reported health status, including symptoms of fatigue, shortness of breath, chest pain, physical and social limitations, and quality of life. MethodsSEQUOIA-HCM (Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM) randomized symptomatic adults with oHCM to 24 weeks of aficamten (n = 142) or placebo (n = 140), followed by a 4-week washout. The Kansas City Cardiomyopathy Questionnaire (KCCQ) and Seattle Angina Questionnaire 7-item (SAQ7) were serially administered. Changes in mean KCCQ—Overall Summary Score (KCCQ-OSS) and SAQ7—Summary Score (SAQ7-SS) from baseline to 24 weeks and following treatment withdrawal were compared using linear regression adjusted for baseline scores and randomization strata. Proportions of patients with clinically important changes were compared. ResultsAmong 282 participants, the mean age was 59 ± 13 years, 115 (41%) were female, and 223 (79%) were White. Baseline KCCQ-OSS (69.3 ± 20.1 vs 67.3 ± 18.8) and SAQ7-SS (72.0 ± 21.0 vs 72.4 ± 18.3) were similar between aficamten and placebo groups. Treatment with aficamten, compared with placebo, improved both the mean KCCQ-OSS (13.3 ± 16.3 vs 6.1 ± 12.6; mean difference: 7.9; 95% CI: 4.8-11.0; P < 0.001) and SAQ7-SS (11.6 ± 17.4 vs 3.8 ± 14.4; mean difference: 7.8; 95% CI: 4.7-11.0; P < 0.001) at 24 weeks, with benefits emerging within 4 weeks. No heterogeneity in treatment effect was found across subgroups. A much larger proportion of participants experienced a very large health status improvement (≥20 points) with aficamten vs placebo (KCCQ-OSS: 29.7% vs 12.4%, number needed to treat: 5.8; SAQ7-SS: 31.2% vs 13.9%, number needed to treat: 5.8). Participants’ health status worsened significantly more after withdrawal from aficamten than placebo (KCCQ-OSS: −16.2 ± 19.0 vs −3.0 ± 9.6; P < 0.001; SAQ7-SS: −17.4 ± 21.4 vs −2.5 ± 13.3), further confirming a causal effect of aficamten. ConclusionsIn patients with symptomatic oHCM, treatment with aficamten resulted in markedly improved health status, including significant improvement in chest pain-related health status, than placebo. (Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM [SEQUOIA-HCM]; NCT05186818)

A comparative study of 70% glycolic acid and 30% trichloroacetic acid peel in the treatment of facial atrophic acne scars: A split-face study.

Medium-depth peels are dynamic tools when used as part of office procedures for the treatment of acne scars. Most of the available literature on chemical peels focuses on their role in skin rejuvenation and hyperpigmentation. There is a paucity of well-conducted studies that have compared peels in the treatment of acne scars in Asian patients. The study aimed to compare the efficacy of 70% glycolic acid (GA) and 30% trichloroacetic acid (TCA) chemical peels in the treatment of facial atrophic acne scars. A longitudinal, right-left study was conducted to assess the effectiveness and side effects of 70% GA and 30% TCA in 30 patients with acne scars. A total of four peeling sessions were performed every 4 weeks. Evaluation of the response was done using Goodman and Baron's quantitative global acne scarring grading system (GBASG), physician visual analog scale (VAS), and patient VAS at baseline and 4, 8, 12, and 16 weeks. Relevant statistical tests were employed to study the effectiveness of both TCA and GA peels. Significant reduction was noted in mean GBASG scores on both sides at 8, 12, and 16 compared to baseline score (P = 0.000). Mean GBASG scores decreased from 12.67 ± 3.19 to 8.97 ± 2.73 on the 70% GA side while that on the 30% TCA side reduced from 13.20 ± 3.56 to 6.83 ± 2.60 (P = 0.003). The results were much better on the TCA peel side as compared to GA peel as per physician VAS (P = 0.000) and patient VAS (P = 0.000). Side effects such as post-inflammatory hyperpigmentation and acne were seen on both sides while dryness and crusting were more common on the TCA peel side. A 30% TCA peel is efficacious and well-tolerated for mild-to-moderate acne scars. About 70% GA peel is an effective alternative to TCA peel, especially for patients not tolerating TCA or requiring lesser downtime.

Helping mentors address scientific communication in STEM research training helps their mentees stay the course

BackgroundScientific communication (SC) has important social-cognitive, behavioral, and career-related benefits for emerging researchers, but both mentors and mentees find development of SC skills challenging. Whether training mentors to effectively mentor development of SC skills could have a meaningful impact on mentees was not clear. The Scientific Communication Advances Research Excellence (SCOARE) project has conducted faculty training workshops in techniques for mentoring SC skills since 2018. To study indirect workshop effects of mentors’ attendance at the SCOARE workshop on their matched PhD and postdoctoral mentees (N = 477), we surveyed mentees before and 6 months after their mentors attended and measured their social-psychological and behavioral outcomes. To examine the effectiveness of the workshop and to explore whether workshop effects vary based on mentee demographic characteristics, including home language variety (speaker of standardized English [STE], non-standardized English [NSTE], or another language [L2]), we conducted multilevel models.ResultsAfter adjusting baseline scores, mentees of mentors who attended SCOARE workshops (W +) were more engaged in speaking activities (β =0 .30, p = 0.016), had higher science identity (β = 0.20, p = 0.048), and were less likely to reconsider their career due to SC skills (β = – 0.39, p = 0.004) than mentees in the W– group. Across demographic groups, mentees of mentors who attended SCOARE workshops showed similar improvements in SC outcomes. Postdoctoral mentees, compared to doctoral mentees, had higher science identity and lower intention to pursue a non-research-intensive career. Comparing mentees of the 3 categories of home language variety, both the NSTE and L2 groups, compared to the STE group, were more likely to reconsider their careers due to SC skills and had a higher intention to pursue non-research-intensive careers both at baseline and post-workshop, suggesting the possibility of language background as a barrier to mentee career progression.ConclusionMentor training for SC skill development can improve social-psychological and behavioral outcomes for mentees, including science identity, frequency of speaking, and reconsideration of research careers due to concerns about SC.

Use of the PRECEDE-PROCEED Model in Piloting Vaccine Promotion and Infection Self-Protection: Intervention Development and Effectiveness Examination.

This study aimed to tailor and pilot a health education program using the PRECEDE-PROCEED model to promote vaccination and enhance self-protective behaviors against COVID-19 in Hong Kong populations. Quasi-experimental study. Phases 1-4 of the PRECEDE-PROCEED model were used to identify the needs for COVID-19 prevention. Strategies to address predisposing, reinforcing, and enabling factors in the PRECEDE-PROCEED model were developed, and an intervention package was generated thereafter. A pre-post experimental study was conducted among 50 participants to preliminarily assess the effects of the intervention based on Phases 5 and 8 of the PRECEDE-PROCEED model. The 3-month intervention package contained 16 health education videos, 36 health tips, individual consultations, regular reminders of vaccination, incentive of anti-epidemic packages, and vaccine booking services. By the third month, 33 participants took a new dose of COVID-19 vaccine, and 5 participants withdrew. The vaccination rate for new dose achieved 73.3% (95% CI: 58.06-85.40%). Compared with the Hong Kong population in the same period, our study demonstrated higher increase in vaccination rate (9.97 vs. 1.36 doses per 1000 person-days). The percentage of early testing in personal and family level increased to 86.7% and 84.4%, respectively (both p < 0.05). For correct mask wearing and hand washing, the scores increased from a baseline score of 9.1 ± 1.6 and 4.9 ± 1.3 to 9.5 ± 1.0 and 5.3 ± 1.2, respectively (both p < 0.05). The application of the PRECEDE-PROCEED model effectively facilitated the stepwise development, implementation, and evaluation of a health education program for improving vaccination rates and fostering self-protective behaviors against infections.

Effects of Kinesio tape on vascularity, pliability and height of the hypertrophic scar in burns patients: a randomized pilot clinical trial.

Deep burns damage the reticular dermis and may lead to the formation of hypertrophic scars. Compression therapy reduces local vascularity and realigns collagen fibers, resulting in esthetic and functional improvements. This study evaluated the effect of Kinesio tape compression with maximum mechanical tension on vascularity, pliability and the height of hypertrophic scars following deep burns. A single blind, randomized pilot clinical trial was carried out. The elastic compression of Kinesio tape was applied at maximum stretch in the intervention group (n=11) and no stretch in the sham group (n=11). Vascularity, pliability and height (the primary outcomes) were evaluated at 0, 45 and 90 days using the Vancouver Scar Scale (VSS). The association between the VSS scores, the intervention and the evaluation moment were analyzed using linear mixed-effects regression models, while comparisons of means between the groups were performed using the t Student test was. Significance was set at 5%. The mean VSS scores were similar between the groups. Significant improvement occurred in both groups when post-treatment and baseline scores were compared. No further improvement was found in the vascularity, pliability or height of hypertrophic scars resulting from deep burns when an elastic compression of Kinesio tape was used at maximum tension compared to lesser mechanical tension.

Comparative efficacy, safety, and tolerability of pharmacotherapies for acute mania in adults: a systematic review and network meta-analysis of randomized controlled trials.

The aim of this study was to provide evidence-based recommendations regarding the efficacy, safety, and tolerability of currently used pharmacological treatments for adults with acute bipolar mania. To achieve this, we conducted a systematic review and network meta-analysis (NMA) using R software and related packages. We searched primary clinical databases until February 2023 for reports of randomized controlled trials of drug treatments and adjunctive therapies for adults with acute bipolar mania, with outcomes including efficacy (mean change from baseline to endpoint in mania rating scores), safety (clinically significant adverse events from baseline to end of treatment), and tolerability (the proportion of patients who completed the whole trial to the planned endpoint). A total of 113 studies were included in our analysis, in which 23,491 participants (50.38% males; mean age = 38.6 years; mean study duration = 3.39 weeks; mean manic baseline score = 29.37) were randomly allocated to one of 51 monotherapies, adjunctive treatments, or placebo. Our results showed that tamoxifen (mean difference, -22.31 [-25.97, -18.63], N = 2, n1 = 43, n2 = 39) and tamoxifen+ lithium or valproate (LIT/VAL) (-16.37 [-22.55, -10.25], N = 1, n1 = 20, n2 = 20) had the best and second-best clinical efficacy in adults with acute bipolar mania over the placebo. Furthermore, olanzapine, paliperidone, quetiapine, ziprasidone, risperidone, divalproex, and haloperidol were significantly better tolerated than placebo. Combination therapies of antipsychotics and LIT/VAL appeared to be more effective than their corresponding monotherapies. While pharmacotherapies were associated with specific common adverse events, we found no evidence of increased incidence of headache or depression events compared to the placebo. Overall, our NMAs provided important insights into the effectiveness, safety, and tolerability of pharmacological treatments for acute bipolar mania and can help guide treatment decisions for clinicians.

EDS-FLU efficacy in patients with chronic rhinosinusitis with or without prior sinus surgery in ReOpen1 and ReOpen2 randomized controlled trials.

The inability of topical medications to reach sinus cavities is a potential reason for lack of efficacy in chronic rhinosinusitis (CRS). One purpose of endoscopic sinus surgery (ESS) is to enable delivery of medications into the sinus cavities. The exhalation delivery system with fluticasone (EDS-FLU; XHANCE) creates unique biomechanics that enable deposition of intranasal corticosteroid into sinuses and sinus drainage pathways but may have differing efficacy in operated versus unoperated sinuses. Two 24-week randomized trials (ReOpen1/2) evaluated EDS-FLU versus EDS-placebo in patients with CRS, stratified by surgical status. Surgery-naive (n=332) and prior-surgery (n=215) patient groups were analyzed as pooled data from ReOpen1/2. Outcome measures (least-squares mean change from baseline) included combined symptom score (CSS) and congestion score at weeks 4, 8, and 12 and average of percentages of opacified volume (APOV) of ethmoid/maxillary sinuses on CT and Sinonasal Outcome Test 22 (SNOT-22) total score at week 24. Baseline scores suggested moderate-severe disease: mean CSS=5.8; APOV=67.2%. EDS-FLU produced significant improvement versus placebo (p<0.05): CSS (surgery-naive, -0.68vs. -1.42; prior ESS, -0.70vs. -1.87); congestion (surgery-naive, -0.24vs. -0.59; prior ESS, -0.24vs. -0.69); and SNOT-22 (surgery-naive, -7.56vs. -18.30; prior ESS, -10.72vs. -18.74). Similar results were observed for APOV (p<0.05). No statistically significant difference was observed between surgery subgroups with either EDS-FLU dose. EDS-FLU improved symptoms, sinus opacification, and quality of life in patients with CRS with or without prior ESS, suggesting a role for EDS-FLU in both populations.

TACKoMesh – A randomised controlled trial comparing absorbable versus non-absorbable tack fixation in laparoscopic IPOM + repair of primary incisional hernia using post-operative pain and quality of life - Reliatack™ versus Protack™

There is a clinical need to better understand and improve post-operative pain for patients undergoing laparoscopic repair of incisional hernia. The aim of this single-centre, double-blind, randomised controlled trial was to compare post-operative pain between absorbable and non-absorbable tack fixation in patients undergoing IPOM + repair. Patients with primary incisional hernia (size 3–10 cm), were randomised to either Reliatack™ (n = 27), an articulating-arm device deploying absorbable polymer tacks, or Protack™ (n = 36), a straight-arm device deploying permanent titanium tacks. The primary outcome was reported pain on activity using a visual analogue scale at post-operative day 30. Clinical and patient-reported outcome measures (PROMs) were assessed pre-operatively (day 0), and at 1-, 6-, 30- and 365-days post-surgery. No significant differences in reported pain ‘on activity’ were found at any timepoint. Less reported pain ‘at rest’ was found on post-operative day-1 with absorbable tacks (p = 0.020). Significantly longer mesh-fixation time (p < 0.001) and the use of more knots for fascial closure (p = 0.006) and tacks for mesh-fixation (p = 0.001) were found for the absorbable tack group. There were no differences in other clinical and PROMs between groups. For the whole trial cohort (n = 63) several domains in the Short-Form-36 showed a reduction from baseline scores at day 30 that improved at day 365. At post-operative day 30, 75.0% of patients reported ‘a lot of pain’ since discharge. This study found no difference in reported pain when choosing absorbable or non-absorbable tack fixation. The utility of “early” post-operative pain assessment as a comparator following incisional hernia repair needs clarification.

Change of self-rated physical health predicts mortality in aging individuals: results of a population-based cohort study

BackgroundSelf-rated physical health (SRPH) is known as an important predictor of mortality. Previous studies mostly used baseline values of self-rated health to predict long-term mortality. The effect of change in self-rated physical health on mortality during the course of aging has rarely been researched. The present study aimed to determine SRPH over time in women and men of an aging population, assess whether and how change in SRPH affects mortality while adjusting for known determinants of mortality, and test effect modification by sex on the relation between course of SRPH and mortality.MethodsData of N = 12,423 respondents of the 5-year follow-up of the Gutenberg Health Study (GHS) with participation at the baseline assessment were analysed. All-cause mortality from 5-year follow-up onwards was defined as the primary outcome. SRPH was assessed by a single item. Cox proportional hazards models with adjustment for age, sex, socio-economic status and physical diseases were fitted to assess the predictive power of baseline score and course of SRPH. Additionally, effect modification by sex was assessed.ResultsDuring a median follow-up period of 7.3 years (quartiles 6.0-8.5 years), 618 (5%) participants died. Overall, 70.9% of the participants indicated good or very good SRPH at baseline (T1) and follow-up (T2), 6.9% rated their SRPH as not so good at T1 and T2, and 0.6% reported bad SRPH at T1 and T2. An improvement of SRPH was indicated by 9.6% and 12.0% indicated deterioration of their SRPH. Change in SRPH added substantial predictive information to the Cox proportional hazards models, when adjusting for relevant covariates. In men, deterioration and constantly bad SRPH were associated with the strongest increase in risk of mortality by 87%, resp. 228%. While improvements increased mortality risk in men (67%), women with an improved SRPH had a lower risk (57%).ConclusionA sizeable subgroup of aging participants reported deterioration of SRPH over five years. The association between change of SRPH and mortality is modified by sex. Deterioration of SRPH predicts mortality over baseline-assessment even when adjusted for relevant covariates. SRPH should be assessed regularly as part of an older individual’s health evaluation. Deterioration, constantly bad and improved SRPH should be taken seriously as unfavorable prognostic indicators, the latter only in men.

Resiliency among older adults receiving lung cancer treatment (ROAR-LCT): A novel supportive care intervention for older adults with advanced lung cancer

IntroductionNovel supportive care interventions designed for an aging population with lung cancer are urgently needed. We aimed to determine the feasibility of a novel supportive care physical therapy (PT) plus progressive muscle relaxation (PMR) intervention delivered to older adults with advanced lung cancer in the United States (US). Materials and MethodsThis clinical trial, Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT: NCT04229381), recruited adults aged ≥60 years with unresectable stage III/IV non-small cell (NSCLC) or small cell lung cancer (SCLC) receiving cancer treatment at The James Thoracic Oncology Center (planned enrollment, N = 20). There were no exclusion criteria pertaining to performance status, laboratory values, prior cancer diagnoses, comorbidities, or brain metastases. Participants were evaluated by PT and psychology and given an exercise pedaler, resistance bands, a relaxation voice recording, and instructions at study initiation. Participants were evaluated in-person by PTs and psychologists at the start and end of the 12-session intervention, with the intervening sessions conducted via virtual health. Participants completed self-reported measures of functional status, symptoms, and mood longitudinally with the following instruments: EQ-5D-5L, Patient Health Questionnaire-9, and General Anxiety Disorder-7. PT assessments included the Short Physical Performance Battery (SPPB) and the two-minute walk test. Feasibility was defined as at least 60% of participants completing at least 70% of all intervention sessions. Optional gut microbiome samples and activity monitoring data (ActiGraph®) were also collected. ResultsThe ROAR-LCT study concluded after consenting 22 patients. Among the 22 consented, 18 (81.8%) started the intervention; 11 participants (61.1%) completed at least 70% of all study sessions. All participants with SCLC completed the intervention. Reasons for withdrawal included progression of disease or hospitalization. The majority (88.9%) of patients who started were able to complete at least one virtual health session. Participants' functional status, SPPB, depression, and anxiety scores were stable from pre- to post-intervention. Participants who withdrew had worse baseline scores across domains. Seven microbiome and six ActiGraph® samples were collected. Discussion: This is one of the first PT + PMR supportive care interventions using virtual health among older adults with advanced lung cancer to achieve feasibility in the US.

Efficacy and safety of self-expandable metallic stents for management of benign gastric outlet obstruction-A prospective study.

We aimed at evaluating the safety and efficacy of self-expandable metallic stent (SEMS) insertion for managing patients with benign gastric outlet obstruction (GOO). This prospective interventional study included 23 patients. All consecutive treatment-naïve symptomatic patients with benign GOO were recruited. Fully covered SEMS were deployed across the stricture under fluoroscopic and endoscopic guidance. Technical success, clinical success and sustained treatment response (STR) were assessed. Technical success was defined as the successful deployment of SEMS at the desired anatomic location. Clinical success was defined as the resolution of symptoms and an increase in Gastric Outlet Obstruction Scoring System (GOOSS) of at least 1 point from the baseline score on Day 7. STR was assessed at four and eightweeks post stent removal in patients who had a response at week four. Factors associated with stent migration and non-response at week four were also assessed. The median age of the study population was 30years (range 19-65years). Males constituted 65.22%. Most patients presented with vomiting (100%) and abdominal pain (95.65%). Peptic stricture was most common etiology for GOO (60.9%) followed by tubercular (26.1%) and corrosive (13%). Most common site of obstruction was junction of first and second part of duodenum (69.57%) followed by pyloric (30.43%). Median length of stricture was 2cm (range 1.5-4). Technical success was achieved in all 23 patients (100%). Clinical success was achieved in 21 patients (91.3%). Response at Day 28 was seen in 20 patients (86.95%). Eighteen of 20 (90%) patients who had a response at week four had STR at week four and week eight after stent removal. Stent migration occurred in five (21.7%) patients. On univariate analysis, stricture length, calibre and stent length were found to predict migration. Fully covered SEMS was an effective and safe management modality in patients with benign GOO. Stent migration remains a troublesome disadvantage.

Cannabis-Containing Cream for CKD-Associated Pruritus: A Double-Blind, Placebo Controlled Trial

Rationale & ObjectiveThis study aims to compare the efficacy of a cannabis cream and a placebo in the treatment of chronic kidney disease (CKD)-associated pruritus. Study DesignA double-blind randomized controlled study. Setting & ParticipantsSixty hemodialysis patients with the Worst Itching Intensity Numerical Rating Scale (WI-NRS) ≥ 3. ExposurePatients received cannabis cream or placebo. OutcomesThe primary endpoint was the WI-NRS score at week 4. The secondary endpoints included the WI-NRS at week 2, Skindex-10 score at week 2 and 4, and the mean difference score between baseline and week 4 for WI-NRS and the Skindex-10 score Analytical ApproachWe utilized unpaired t-tests or Mann–Whitney U tests, along with Chi-square or Fisher’s exact tests as appropriate. Adjusted mean differences were determined using ANCOVA, adjusting for baseline scores. ResultsAmong 60 participants, mean age was 61.6 ± 14.4 years and mean baseline WI-NRS was 6.7 ± 1.7. The placebo and cannabis cream groups were similar at baseline, although more individuals in the placebo group had diabetes. At 4 weeks, the WI-NRS dropped to 2.6 in the cannabis group and 3.6 in the placebo group (mean difference after adjustment for baseline scores:-1.1, 95% CI: -2.1 to -0.2, p = 0.02). Skindex-10 scores at week 4 were also lower in the cannabis group, but after adjustment for baseline scores, statistical significance was not maintained. No side effects were observed in either group. LimitationsA single study with a small sample size restricts its generalizability. Variances in participants' diabetes statuses might have impacted itch outcomes. The absence of cannabinoid level assessment in blood prevents conclusive determination of potential systemic impacts. A four-week follow-up period inadequately captures long-term effect. ConclusionsIn CKD-associated pruritus, the topical cream containing cannabis significantly reduced the severity of itching symptoms compared to the placebo.

One-year evaluation of people recovering from COVID-19 receiving allied primary healthcare: A nationwide prospective cohort study

BackgroundA Dutch nationwide prospective cohort study was initiated to investigate recovery trajectories of people recovering from coronavirus disease 2019 (COVID-19) and costs of treatment by primary care allied health professionals. ObjectivesThe study described recovery trajectories over a period of 12 months and associated baseline characteristics of participants recovering from COVID-19 who visited a primary care allied health professional. It also aimed to provide insight into the associated healthcare and societal costs. MethodsParticipants completed participant-reported standardized outcomes on participation, health-related quality of life, fatigue, physical functioning, and costs at baseline (ie, start of the treatment), 3, 6, 9 and 12 months. ResultsA total of 1451 participants (64 % women, 76 % mild/moderate severity) with a mean (SD) age of 49 (12) years were included. Linear mixed models showed significant and clinically relevant improvements over time in all outcome measures between baseline and 12 months. Between 6 and 12 months, we found significant but not clinically relevant improvements in most outcome measures. Having a worse baseline score was the only baseline factor that was consistently associated with greater improvement over time on that outcome. Total allied healthcare costs (mean €1921; SEM €48) made up about 3% of total societal costs (mean €64,584; SEM €3149) for the average participant in the cohort. ConclusionsThe health status of participants recovering from COVID-19 who visited an allied health professional improved significantly over a 12-month follow-up period, but nearly the improvement occurred between baseline and 6 months. Most participants still reported severe impairments in their daily lives, and generated substantial societal costs. These issues, combined with the fact that baseline characteristics explained little of the variance in recovery over time, underscore the importance of continued attention for the management of people recovering from COVID-19. Trial registrationclinicaltrials.gov (NCT04735744)

Repetitive Transcranial Magnetic Stimulation with Body Weight-supported Treadmill Training Enhances Independent Walking of Individuals with Chronic Incomplete Spinal Cord Injury: A Pilot Randomized Clinical Trial.

The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) combined with body weight-support treadmill training (BWSTT) for improving walking function of individuals with chronic incomplete spinal cord injury (iSCI). A 4-week, double-blinded, randomized, sham-controlled pilot study involved 12 sessions of real (10Hz, 1800 pulses) or sham rTMS combined with BWSTT (15-20min, moderate intensity). Walking independence was assessed using the Walking Index for Spinal Cord Injury II (WISCI-II). Lower extremity motor function (lower extremity motor score [LEMS]) and spasticity, sensory function, functional independence (Spinal Cord Injury Measure III [SCIM-III]), and quality of life were also assessed. Walking independence (WISCI-II) after the 6th session was higher in the BWSTT/rTMS real (n = 7) (median change (IQR): 3 (1.5 to 3.5)) than in the sham group (n = 8) (median change (IQR): 0 (0 to 0.25), but there was no difference between groups after 12th session (BWSTT/rTMS real median change (IQR): 4 (2 to 5); BWSSTT/rTMS sham median change (IQR): 0 (0 to 3.25). Compared to baseline, LEMS and SCIM-III mobility scores were increased after 12 sessions in the BWSTT/rTMS real but not in the sham group. Within- and between-group sensory function, functional independence, and quality of life remained similar. This preliminary result suggests that combining BWSTT with rTMS could lead to earlier gait improvement in patients with chronic iSCI.