Evaluation of a five-layer hydrocellular polyurethane foam dressing across wound care settings in southern Europe.

OBJECTIVE: The burden of chronic wounds did not disappear during the Covid-19 pandemic, so new ways to address healthcare practitioner (HCP) education had to evolve. The Teach, Try, and Talk (T3) programme was conceived in 2021 with HCPs in southern Europe (Italy, Spain and Portugal). METHOD: Virtual education sessions with experienced HCP guest speakers were held and a five-layer hydrocellular polyurethane foam dressing (HPFD) was introduced as a way of reducing dressing change frequencies and improving clinician satisfaction. HCPs recorded their experience of the HPFD using an online form and participated in a further virtual session with experienced HCPs to discuss the results. RESULTS: There were a total of 190 responses. A significant dressing change reduction from 3.6 changes per week to 1.8 with the HPFD (p<0.001) was observed in Italy, Spain and Portugal and within different care settings (hospital, wound clinic/health centre and the patient's home). Nearly one-third of participants stated one more day of dressing wear time was achieved by the ability of the HPFD to lock in and manage exudate, with nearly a quarter of responses stating it was due to fewer than three dressing lobes being full. The majority (97.8%) of HCPs stated they would recommend the HPFD to colleagues and patients. CONCLUSION: The T3 programme is a highly successful method of training delivery and practice improvement across a variety of healthcare settings in southern Europe, helping support HCP engagement and ongoing development in challenging times during the Covid-19 pandemic. The programme can be adapted considering the needs of different HCPs and payor and/or healthcare systems.

Comparison of topical purslane & topical 0.1% triamcinolone acetonide in the management of oral lichen planus - a double blinded clinical trial.

AIM AND BACKGROUND: Oral lichen planus (OLP) is a chronic autoimmune mucocutaneous disorder of unknown etiology and treatment is targeted at alleviating symptoms. At present, corticosteroids are the mainstay treatment, and their side effects hamper their long-term use, demanding alternative therapy. This study intended to assess the efficacy of topical purslane (Portulaca oleracea) at two concentrations, 5% and 10%, in OLP and to compare the level of clinical improvement in comparison to topical 0.1% triamcinolone acetonide gel. MATERIALS AND METHODS: After sample size determination, thirty-four subjects confirmed histopathologically with OLP were included in the study. They were divided into 3 groups, Group 1(Control) was treated with 0.1% triamcinolone acetonide, and Group 2(Case) and 3 (Case) were treated with topical purslane 5% and 10%, respectively. They were examined at baseline, 14 days, 30 days, 60 days, and 90 days. Clinical improvement was then analyzed at the end of 90 days using a visual analog scale (VAS) and Thongprasom's criteria. RESULTS: The study was analyzed statistically and a P value of < 0.05 was considered statistically significant. Intragroup comparison revealed a statistically significant difference between the five time periods (baseline, 14 days, 30 days, 60 days, and 90 days) for the study variables (burning sensation, pain, lesion score, clinical response, symptomatic response) for all three groups (p = 0.001). Alleviation of all symptoms and remission of the lesion were noted for all three groups at the end of three months. CONCLUSION: Purslane is a magical herb with a plethora of rich nutrients, ease in accessibility and devoid of side effects. It was concluded that its preparation is beneficial and can be a safer alternative long-term drug for the management of OLP. CLINICAL SIGNIFICANCE: With available literature evidence, our present study is the first of its kind to formulate a topical gel with purslane to treat symptomatic OLP. Our study had a longer follow-up of 3 months compared to other studies in the literature.

Clinical Improvement, Outcomes, Antiviral Activity, and Costs Associated With Early Treatment With Remdesivir for Patients With Coronavirus Disease 2019 (COVID-19).

BACKGROUND: Evidence remains inconclusive on any significant benefits of remdesivir in patients with mild-to-moderate COVID-19. This study explored the disease progression, various clinical outcomes, changes in viral load, and costs associated with early remdesivir treatment among COVID-19 patients. METHODS: A territory-wide retrospective cohort of 10 419 patients with COVID-19 hospitalized from 21 January 2020 to 31 January 2021 in Hong Kong was identified. Early remdesivir users were matched with controls using propensity-score matching in a ratio ≤1:4. Study outcomes were time to clinical improvement of at least 1 point on WHO clinical progression scale, hospital discharge, recovery, viral clearance, low viral load, positive IgG antibody, in-hospital death, and composite outcomes of in-hospital death requiring invasive ventilation or intensive care. RESULTS: After multiple imputation and propensity-score matching, median follow-up was 14 days for both remdesivir (n = 352) and control (n = 1347) groups. Time to clinical improvement was significantly shorter in the remdesivir group than that of control (HR: 1.14; 95% CI: 1.01-1.29; P = .038), as well as for achieving low viral load (1.51; 1.24-1.83; P < .001) and positive IgG antibody (1.50; 1.31-1.70; P < .001). Early remdesivir treatment was associated with lower risk of in-hospital death (HR: .58; 95% CI: .34-.99; P = .045), in addition to a significantly shorter length of hospital stay (difference: -2.56 days; 95% CI: -4.86 to -.26; P = .029), without increasing risks of composite outcomes for clinical deterioration. CONCLUSIONS: Early remdesivir treatment could be extended to hospitalized patients with moderate COVID-19 not requiring oxygen therapy on admission.

Optimal Timing of Remdesivir Initiation in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19) Administered With Dexamethasone.

BACKGROUND: Evidence is lacking about any additional benefits of introducing remdesivir on top of dexamethasone, and the optimal timing of initiation. METHODS: In a territory-wide cohort of 10 445 coronavirus disease 2019 (COVID-19) patients from Hong Kong who were hospitalized between 21 January 2020 and 31 January 2021, 1544 had received dexamethasone during hospitalization. The exposure group consisted of patients who had initiated remdesivir prior to dexamethasone (n = 93) or co-initiated the 2 drugs simultaneously (n = 373), whereas the nonexposure group included patients who were given remdesivir after dexamethasone (n = 149) or those without remdesivir use (n = 929). Multiple imputation and inverse probability of treatment weighting for propensity score were applied and hazard ratios (HRs) of event outcomes were estimated using Cox regression models. RESULTS: Time to clinical improvement (HR = 1.23; 95% CI, 1.02-1.49; P = .032) and positive IgG antibody (HR = 1.22; 95% CI, 1.02-1.46; P = .029) were significantly shorter in the exposure group than that of nonexposure. The exposure group had a shorter hospital length of stay by 2.65 days among survivors, lower WHO clinical progression scale scores from 5 days of follow-up onwards, and lower risks of in-hospital death (HR = .59; 95% CI, .36-.98; P = .042) and composite outcomes; and without experiencing an increased risk of acute respiratory distress syndrome. Differences in the cumulative direct medical costs between groups were no longer significant from 17 days of follow-up onwards. CONCLUSIONS: Initiation of remdesivir prior to or simultaneously with dexamethasone was associated with significantly shorter time to clinical improvement and positive IgG antibody, lower risk of in-hospital death, in addition to shorter length of hospital stay in patients with moderate COVID-19.

The association between anti-acetylcholine receptor antibody level and clinical improvement in myasthenia gravis.

BACKGROUND AND PURPOSE: Anti-acetylcholine receptor (AChR) antibodies (ab) in the serum are detected in most patients with generalized myasthenia gravis (MG) and used as a diagnostic tool. The aim of this study was to analyse a possible association between anti-AChR-ab serum levels and clinical improvement of MG. METHODS: The Maastricht University Medical Center is a centre of expertise for the treatment of MG. Between 1997 and 2020, more than 4000 anti-AChR-ab blood samples were measured for clinical care using a quantitative radioimmunoassay technique. These results, in combination with clinical status obtained from the patients' electronic patient files, were retrospectively analysed by a single blinded clinician. Symptoms of MG were classified using the Myasthenia Gravis Foundation of America (MGFA) scale. RESULTS: In total, 90 anti-AChR-ab-positive MG patients with 837 blood samples were included. The median follow-up time was 72 months. The majority of the included patients were women (61.1%), were on immunosuppressive drug therapy (88.9%), and underwent a thymectomy (54.4%). Multilevel logistic regression analysis showed a significantly inverse association between change in anti-AChR-ab level and the odds of MGFA improvement (per 10% decrease of anti-AChR-ab level: odds ratio 1.21, 95% confidence interval 1.12-1.31; p < 0.001). CONCLUSIONS: A change in anti-AChR-ab serum level is associated with clinical status in patients with MG. Analyses of anti-AChR-ab are not only useful for diagnostics but also in follow-up of adult symptomatic patients with MG. The use of repetitive anti-AChR-ab serum levels might be valuable in long-term monitoring for clinical improvement in patients with MG, however, further research is required for specific recommendations.

Use of the optimized sodium thiosulfate regimen for the treatment of calciphylaxis in Chinese patients.

BACKGROUND: Sodium thiosulfate (STS) can be used to treat patients diagnosed with calciphylaxis, which is a rare life-threatening syndrome. However, our patients treated with the recommended STS regimen presented with serious adverse events, resulting in treatment withdrawal. Then an optimized STS regimen was used to increase the tolerance of patients to STS and improve treatment continuation. The curative effect of the new regimen is not yet definite. Therefore, this study aimed to evaluate the response to the use of the optimized STS regimen for the treatment of calciphylaxis in Chinese patients during the first three courses of treatment. METHODS: Demographic, clinical, and laboratory data were retrospectively collected on 31 calciphylaxis patients with chronic kidney disease (CKD) or end-stage kidney disease (ESKD) treated with the optimized STS regimen. The primary outcome was a clinical improvement. The secondary outcomes included survival rate and adverse events. RESULTS: Twenty-five patients (over 80%) achieved clinical improvement considering improvement or nonspecific changes of skin lesions (80.65%) and pain relief (100%). Furthermore, 54.84% of patients did not experience any adverse events and none died from complications. During a median follow-up of 9 months (interquartile range 4‒19), 27 patients (87.10%) survived; additionally, 13 patients (41.94%) survived after a one-year follow-up period. CONCLUSION: The optimized STS regimen is relatively safe, associated with satisfactory outcomes, and well tolerated by patients for short to medium treatment duration. Hence, it is a promising approach for the treatment of patients diagnosed with calciphylaxis.

In the Era of Direct-Acting Antivirals, Liver Transplant Delisting Due to Clinical Improvement for Hepatitis C Remains Infrequent.

BACKGROUND / AIMS: Studies have suggested marked increases in transplant delisting due to clinical improvement for patients with hepatitis C virus (HCV) associated cirrhosis in the era of direct acting antivirals (DAAs). This study provides a 'real world' assessment of waitlist dynamics for HCV transplant candidates in the current era. METHODS: This was a retrospective cohort study of adults waitlisted for liver transplant (LT) alone between 1/1/2005-12/31/2018 using national US data. The post-DAA era included all listings occurring after 1/1/2013. Temporal trends in waitlisting, patient characteristics and outcomes with decompensated cirrhosis were evaluated. Adjusted competing risks models assessed the interaction of DAA-era and HCV history on (i) waitlist mortality, and (ii) delisting due to clinical improvement. RESULTS: Overall listing rates for HCV patients have decreased in the DAA era and particularly with Model for End-stage Liver Disease score ≥15 and ≥30. Rates of refractory ascites and severe encephalopathy at listing have increased. Delisting due to clinical improvement remains low (6.1% for 2013-2017 versus 5.2% for 2009-2012 versus 4% for 2005-2008; p < .001) and, for many, ascites (46.5%) and encephalopathy (30.5%) persist at delisting. Waitlist recovery is more frequent for HCV patients post-DAA (adjusted SHR 1.78 vs pre-DAA, 95% CI: 1.58-2.02; p < .001), while improvements in waitlist mortality by era are similar to non-HCV candidates (adjusted SHR 0.74 [95% CI: 0.7-0.78; p < .001] and 0.77 [95% CI: 0.74-0.8; p < .001], respectively). CONCLUSION: Listing rates for decompensated HCV cirrhosis have decreased in the DAA era. Delisting of HCV patients for clinical improvement has increased, but remains infrequent and many continue to experience considerable morbidity.

Pretreatment intranetwork connectivity can predict the outcomes in idiopathic tinnitus patients treated with sound therapy.

Previous studies demonstrated that brain morphological differences and distinct patterns of neural activation exist in tinnitus patients with different prognoses after sound therapy. This study aimed to explore possible differences in intrinsic network-level functional connectivity (FC) in patients with different outcomes after sound therapy (narrow band noise). We examined intrinsic FC using resting-state functional magnetic resonance imaging in 78 idiopathic tinnitus patients (including 35 effectively treated and 43 ineffectively treated) and 52 healthy controls (HCs) via independent component analysis. We also investigated the associations between the differences in FC and clinical variables. Analyses revealed significantly altered intranetwork connectivity in the auditory network (AUN) and some nonauditory-related networks in the EG/IG patients compared to HCs; compared with EG patients, IG patients showed decreased intranetwork connectivity in the anterior default mode network (aDMN) and AUN. Meanwhile, robust differences were also evident in internetwork connectivity between some nonauditory-related networks (salience network and executive control network; posterior default mode network and dorsal attention network) in the EG relative to IG patients. We combined intranetwork connectivity in the aDMN and AUN as an imaging indicator to evaluate patient outcomes and screen patients before treatment; this approach reached a sensitivity of 94.3% and a specificity of 76.7%. Our study suggests that tinnitus patients with different outcomes show distinct network-level functional reorganization patterns. Intranetwork connectivity in the aDMN and AUN may be indicators that can be used to predict prognoses in patients with idiopathic tinnitus and screen patients before sound therapy.

Funding Innovative Dialysis Technology in the United States: Home Dialysis and the ESRD Transitional Add-on Payment for New and Innovative Equipment and Supplies (TPNIES).

Innovative, patient-centered, and pragmatic dialysis technologies are urgently needed to accommodate the growing national interest in home dialysis use. To help achieve this goal, the US Centers for Medicare & Medicaid Services (CMS) are expanding reimbursement for eligible home dialysis machines through an existing payment mechanism, the transitional add-on payment for new and innovative equipment and supplies (TPNIES). This mechanism incentivizes the early adoption of innovative equipment into practice by reimbursing dialysis providers up to 26% of the total cost of approved home dialysis machines. Machines are evaluated for TPNIES eligibility using prespecified substantial clinical improvement (SCI) criteria that are derived from the Inpatient Prospective Payment System (for non-nephrology technologies). Although the SCI criteria may be suitable for some non-nephrology technologies, they have not been adapted to consider the unique and complex care inherent in home dialysis. Thus, many of the SCI criteria appear unsuitable for home dialysis machines. To better incentivize innovation, CMS should develop nephrology-specific transparent and pragmatic criteria for TPNIES. In this perspective, we provide an overview of the TPNIES payment mechanism, highlight areas of concern within the policy, and offer solutions for improving TPNIES that could better promote the adoption of new home dialysis machines.

Favipiravir for the treatment of patients with COVID-19: a systematic review and meta-analysis.

BACKGROUND: Favipiravir possesses high utility for treating patients with COVID-19. However, research examining the efficacy and safety of favipiravir for patients with COVID-19 is limited. METHODS: We conducted a systematic review of published studies reporting the efficacy of favipiravir against COVID-19. Two investigators independently searched PubMed, the Cochrane Database of Systematic Reviews, MedRxiv, and ClinicalTrials.gov (inception to September 2020) to identify eligible studies. A meta-analysis was performed to measure viral clearance and clinical improvement as the primary outcomes. RESULTS: Among 11 eligible studies, 5 included a comparator group. Comparing to the comparator group, the favipiravir group exhibited significantly better viral clearance on day 7 after the initiation of treatment (odds ratio [OR] = 2.49, 95% confidence interval [CI] = 1.19-5.22), whereas no difference was noted on day 14 (OR = 2.19, 95% CI = 0.69-6.95). Although clinical improvement was significantly better in the favipiravir group on both days 7 and 14, the improvement was better on day 14 (OR = 3.03, 95% CI = 1.17-7.80) than on day 7 (OR = 1.60, 95% CI = 1.03-2.49). The estimated proportions of patients with viral clearance in the favipiravir arm on days 7 and 14 were 65.42 and 88.9%, respectively, versus 43.42 and 78.79%, respectively, in the comparator group. The estimated proportions of patients with clinical improvement on days 7 and 14 in the favipiravir group were 54.33 and 84.63%, respectively, compared with 34.40 and 65.77%, respectively, in the comparator group. CONCLUSIONS: Favipiravir induces viral clearance by 7 days and contributes to clinical improvement within 14 days. The results indicated that favipiravir has strong possibility for treating COVID-19, especially in patients with mild-to-moderate illness. Additional well-designed studies, including examinations of the dose and duration of treatment, are crucial for reaching definitive conclusions.

Peroral endoscopic myotomy for the treatment of esophageal diverticulum: an experience in China.

BACKGROUND: With the development of minimally invasive endoscopic approaches for the esophagus in recent years, peroral endoscopic myotomy (POEM) in the treatment of esophageal diverticulum has been described recently in some reports due to its successful outcomes. The aim of this study is to report our experience with the use of diverticular POEM (D-POEM) technique in the management of esophageal diverticulum. METHODS: This retrospective study included consecutive patients with symptomatic esophageal diverticulum who visited our endoscopy center between April 2014 and January 2019. D-POEM was performed based on the principles of submucosal endoscopy. A new symptomatic scoring system was introduced to evaluate the severity of diverticular symptoms. RESULTS: A total of 10 patients with esophageal diverticulum (Zenker's 2, mid-esophagus 5, and epiphrenic 3) were included. The overall technical success rate of D-POEM was 100%, with a mean procedure time of 38.9 ± 20.5 (range 16-70) min. No serious complications occurred. Clinical improvement was achieved in 90% (9/10) of patients. The symptomatic score was significantly decreased from 2.5 (IQR 2.00-3.25) to 1.0 (IQR 0-1.25) (P = 0.007) during a median follow-up period of 11.0 (IQR 10.25-17.25) months. CONCLUSION: These findings suggested complete septotomy by D-POEM. Our preliminary data and experience put forwarded D-POEM as a safe and effective technique for esophageal diverticulum.

Predictors associated with clinical improvement of SARS-CoV-2 pneumonia.

BACKGROUND: There are few agents that have been proven effective for COVID-19. Predicting clinical improvement as well as mortality or severity is very important. OBJECTIVES: This study aimed to investigate the factors associated with the clinical improvement of COVID-19. METHODS: Overall, 74 patients receiving treatment for COVID-19 at Tokyo Medical and Dental University Hospital from April 6th to May 15th, 2020 were included in this study. Clinical improvement was evaluated, which defined as the decline of two levels on a six-point ordinal scale of clinical status or discharge alive from the hospital within 28 days after admission. The clinical courses were particularly investigated and the factors related to time to clinical improvement were analyzed with the log-rank test and the Cox proportional hazard model. RESULTS: Forty-nine patients required oxygen support during hospitalization, 22 patients required invasive mechanical ventilation, and 5 patients required extracorporeal membrane oxygenation. A total of 83% of cases reached clinical improvement. Longer period of time from onset to admission (≥10 days) (HR, 1.057; 95% CI, 1.002-1.114), no hypertension (HR, 2.077; 95% CI, 1.006-4.287), and low D-dimer levels (<1 µg/ml) (HR, 2.372; 95% CI, 1.229-4.576) were confirmed to be significant predictive factors for time to clinical improvement. Furthermore, a lower SARS-CoV-2 RNA copy number was also a predictive factor for clinical improvement. CONCLUSIONS: Several predictors for the clinical improvement of COVID-19 pneumonia were identified. These results may be important for the management of COVID-19 pneumonia.

Intra-articular hyaluronic acid in knee osteoarthritis: clinical data for a product family (ARTHRUM), with comparative meta-analyses.

INTRODUCTION: Viscosupplementation is widely practiced, to reduce pain in osteoarthritis (OA), using intra articular (IA) injections of hyaluronic acid (HA). In Europe, these products are class III medical devices, for which the Medical Device Regulation (MDR) requires clinical assessment, based on specific studies and/or a bibliographical review of equivalent devices. The purpose of this article is to present a comparative review between a family of devices (ARTHRUM, from LCA Pharmaceuticals, Chartres, France) and an extensive group of presumed equivalent IA HA devices or their controls, whose results have been published in Scientific journals. METHODS: To meet the criteria used in most ARTHRUM studies, the Western Ontario and McMaster Universities' index sub-scores were selected for pain (WOMAC A), stiffness (WOMAC B) and function (WOMAC C). The main criterion was the variation of the WOMAC A score from T0 (date of inclusion) to T6 (6 months). The other WOMAC criteria were assessed at T1, T3, T6 and complemented by OMERACT-OARSI rates of responders to the treatment. Fifty articles were selected, containing treatment details on more than 12,000 patients. These were divided into three groups: ARTHRUM, EQUIVALENTS and CONTROLS. To get quantitative comparisons, meta-analyses were performed for each criterion individually. The 95% confidence interval of each difference from baseline, was used to assess the clinical relevance, with reference to a minimum validated in OA literature. Comparisons between groups and tolerance assessment completed the investigation. RESULTS: For the WOMAC A, B and C scores, the full 95% CI was always above the minimal perceptible clinical improvement (MPCI), in the ARTHRUM and EQUIVALENTS groups, but not for all criteria in the CONTROLS group. In the comparisons, both ARTHRUM and EQUIVALENTS groups were significantly better than the CONTROLS group for each criterion. The effect size (ES) on pain, for the ARTHRUM and EQUIVALENTS groups, varied from 0.28 to 0.56 and from 0.23 to 0.27, respectively. Overall, ARTHRUM was estimated always non-inferior to EQUIVALENTS, and sometimes statistically and clinically superior. CONCLUSIONS: The comparison of ARTHRUM clinical studies, with studies selected through bibliographic research, leads to the conclusion that the clinical efficacy of the ARTHRUM medical devices, to reduce pain and improve the function in knee OA, during a six-month period, is at least as great as those of equivalent products. With good tolerance results (lowest rate of adverse events, and none of them serious), the risk benefit ratio favours using viscosupplementation with ARTHRUM.

Primary lung cancer diagnoses in people living with HIV in a large clinical centre in Montreal, Canada over 3 decades.

Lung cancer is the most frequent type of cancer-related death in people living with HIV (PLWH). We conducted a review of primary lung cancers in PLWH at the McGill University Health Centre from 1988-May 2018 to understand potential factors contributing to their development prior to the implementation of a lung cancer screening program. Twenty-seven individuals had a diagnosis of a lung tumor. Of these individuals, 21 (78%) had a primary lung cancer, over 21,428 person-years follow-up. Median age was 54.5 years [25th and 75th percentiles 49.0, 62.0]. Median CD4 count was 185.0 cells/µL [25th and 75th percentiles 54.0, 446.0] and 52% were on antitretroviral therapy with suppressed viral loads. Type of primary lung cancer included: non-small cell lung cancer (n = 15), small-cell lung cancer (n = 4) and bronchial carcinomas (n = 2). Metastatic disease at diagnosis was present in 11 (52%) persons. Survival was a median of 7.5 months from the time of diagnosis [25th and 75th percentiles 2.0, 9.0]. In conclusion, we observed a high proportion of lung cancers detected at very late stages of disease and with metastatic involvement. The implementation of a lung cancer screening program in 2018 should set a stage shift for earlier diagnosis and treatment.

Does patient expectancy account for the cognitive and clinical benefits of mindfulness training in older adults?

OBJECTIVES: Patient expectations of treatment effects could influence neuropsychological and clinical outcomes in clinical trials of behavioral and lifestyle interventions, which could potentially confound the interpretation of findings. Our aim was to examine whether patient expectancy mediated effectiveness of Mindfulness-Based Stress Reduction (MBSR) for improving cognitive function and clinical outcome. METHODS: The present study uses data from a single-blind, multi-site, randomized controlled trial comparing MBSR to a health education attention control in older adults with anxiety and/or depressive disorders and subjective cognitive concerns. Using the Credibility and Expectations Questionnaire, we measured expectancy and perceived credibility of the interventions assigned to patients. Using mediational analysis, we examined the influence of expectancy and credibility on two key outcomes: memory performance and clinical global improvement. RESULTS: Neither expectancy nor perceived credibility of intervention accounted significantly for MBSR's effectiveness for memory test performance or clinical global improvement. CONCLUSION: In this clinical trial, expectancy for improvement did not account for the effectiveness of MBSR on memory performance or clinical outcomes in depressed and anxious older adults. We advise that clinical trials of behavioral and lifestyle interventions for brain health in older adults should measure and test the role of expectancy.

Maximal flexion and patient outcomes after TKA, using a bicruciate-stabilizing design.

INTRODUCTION: Physiological motion after total knee arthroplasty (TKA) should result in a large range of motion, which would lead to good clinical outcomes. An adjusted design of a bicruciate-stabilizing TKA was developed to reproduce physiological motion. The aim of this study was to (1) investigate the maximal knee flexion of this knee system, 1 year post-operatively; (2) determine the clinical and functional improvement and compare the outcomes between patients with and without high maximal flexion; and (3) evaluate the adverse events. MATERIALS AND METHODS: In this prospective study, 62 patients with osteoarthritis received a bicruciate-stabilizing TKA. Maximum flexion was measured on a lateral X-ray pre- and post-operatively. Clinical and functional scores and the adverse events were reported up until 2 years after surgery. RESULTS: Pre-operatively, the median (range) maximal flexion was 131.5 (90-153)° and 1 year post-operatively, it was 130 (82-150)°. The results for the clinical scores showed an improvement between pre-operative values and post-operative values. The Kujala score and Knee Osteoarthritis Outcome Score (KOOS) symptoms, sport and quality of life score were better in patients with high maximal flexion (≥ 125°). Ten (serious) adverse device events were reported. CONCLUSIONS: In conclusion, the bicruciate-stabilizing TKA obtained a maximal flexion comparable to the flexion pre-operatively and resulted in good clinical and functional outcomes. Patients with high flexion ability seem to perform better on clinical and functional outcomes. Furthermore, the adjusted design of the bicruciate-stabilizing TKA reduced the number of adverse events. LEVEL OF EVIDENCE: Prospective cohort study, Level II.

The Clinical Relevance of Pain Severity Changes: Is There Any Difference Between Asian and Caucasian Patients With Osteoarthritis Pain?

The objective of the present analysis was to determine whether changes in Brief Pain Inventory (BPI) average pain scores by patient global impression of improvement (PGI-I) category and the cut-off for clinically important difference (CID) were different between Asian and Caucasian patients with chronic pain due to osteoarthritis. This analysis used data from 3 (Caucasian) and 2 (Asian) randomized, placebo-controlled, 10- to 14-week duloxetine studies for the treatment of patients ≥40 years of age with osteoarthritis pain. The receiver operating characteristic (ROC) analysis was used to characterize the association between changes in BPI average pain scores and PGI-I levels at study endpoint. The CID was characterized by PGI-I, and the cut-off point for CID in BPI average pain scores was determined by the intersection of a 45-degree tangent line with each ROC curve. Data from 668 Asian and 868 Caucasian patients were available for analysis. Baseline BPI average pain ratings including worst and least pain were comparable between Asians and Caucasians. Ratings for percentage change from baseline to endpoint for BPI average pain scores in Asian patients and Caucasian patients were similar across the 7 PGI-I categories, regardless of age, gender, study, and treatment. The ROC analysis results of cut-off points in BPI average pain scores demonstrated the raw change cut-off was -3.0, and percentage change cut-off was -40% for both Asian and Caucasian patients. Overall, the present analysis concludes changes in BPI average pain scores by PGI-I category and the cut-off for CID were similar for Asian and Caucasian patients with chronic pain due to osteoarthritis.

Are there interventions that improve breastfeeding and the use of breast milk in late preterm infants?

To answer the clinical question 'Among late preterm infants are there any interventions that improve the rates of breastfeeding and the use of breast milk compared with current practice?'. MEDLINE via Ovid, Embase via Ovid, the Maternity and Infant Care Database and the Cochrane Library were searched for relevant articles. Articles were excluded if they did not discuss specific interventions to improve breastfeeding, for example, if they only commented on factors such as age, race and education. Articles were also excluded if they were not specific to the late preterm infant population. A total of 516 articles were found and screened by title and abstract independently by two reviewers. The full text of 17 articles was independently reviewed. The reference lists of these full-text articles were screened, and 14 abstracts were subsequently reviewed. The final analysis included three studies. There is limited high-quality research evidence for interventions to improve breastfeeding in late preterm infants. In the absence of robust academic research, clinical practice should be guided by clinical expertise and involve a multidisciplinary team, including qualified lactation consultants. While it seems reasonable for hospitals to support interventions that improve breastfeeding in term infants, managing late preterm infants as healthy term infants without additional specialist support may result in high breastfeeding failure rates among late preterm infants.

What evidence-based strategies have been shown to improve breastfeeding rates in preterm infants?

Breast milk is the preferred form of nutrition for all infants and has been shown to reduce morbidity and improve health outcomes in preterm infants. However, mothers of preterm infants face many challenges initiating and sustaining breastfeeding within the neonatal unit. This scoping review examines evidence-based practices which aim to improve breastfeeding rates in preterm infants at the time of hospital discharge. A literature review identified 17 articles which are included in this review. Supporting evidence was found for the implementation of kangaroo mother care and/or skin-to-skin care, peer counsellors, provision of oropharyngeal colostrum in early infancy and use of donor human milk banks. However, overall it is apparent that high quality research including systematic review and data synthesis in the form of meta-analysis is required in this area to reach sound conclusions regarding recommendations of different interventions. This scoping review provides an important foundation for further research into this area.

Determinants for Meaningful Clinical Improvement of Pain and Health-Related Quality of Life After Spinal Cord Stimulation for Chronic Intractable Pain.

OBJECTIVES: Previous studies demonstrated significant improvement in mean pain scores and quality of life (QOL) scales in patients with chronic pain who underwent spinal cord stimulation (SCS). However, the number of individuals who experience relevant improvements in QOL, termed the meaningful clinical improvement (MCI), is not known. The present study investigated changes in pain measurements based on MCI after SCS. MATERIALS AND METHODS: Thirty-four patients with chronic intractable pain completed scales of pain (visual analogue scale [VAS]), QOL (SF-36), and psychological dimensions during a 22-month follow-up period (mean). Patient-centered MCI of the VAS and SF-36 domain scores were determined based on the MacNab criteria of surgical global effectiveness. Independent presurgical predictors for MCI in the VAS and SF-36 domains were analyzed using multiple binary logistic regression. RESULTS: There was significant improvement of pain and QOL after the SCS (p < 0.00001). Twenty-three patients (67.6%) reached an MCI of pain, and 16 (47.7%)-23 (67.7%) reported an MCI of QOL. Predictors of MCI included ≥80% paresthesia coverage of the painful area, lower levels of anxiety and catastrophizing symptoms, shorter pain duration, female gender and no use of opioids before surgery. MCI of pain and QOL was observed in 50%-70% of patients with chronic pain after SCS. CONCLUSIONS: The identification of determinants for MCI is a challenge to improve the accuracy of prognostic models in SCS for patients with chronic pain. Our results, if confirmed in other populations with a larger sample size, have implications for patients with chronic pain who are candidates for SCS treatment.