Benefits Of Therapy Research Articles

Defining benefit: Clinically and biologically meaningful outcomes in the next-generation Alzheimer's disease clinical care pathway.

To understand the potential benefits of emerging Alzheimer's disease (AD) therapies within and beyond clinical trial settings, there is a need to advance current outcome measurements into meaningful information relevant to all stakeholders. The relationship between the impact on disease biology and clinically measurable outcomes in cognition, function, and behavior must be considered when defining the meaningful benefit of early AD therapies. In this review, we discuss: (1) the lack of consideration for biomarkers in the current concept of meaningfulness in AD; (2) the lack of gold standards for determining minimal biologically and clinically important differences (MBCIDs) in AD trials; (3) how the treatment benefits of disease-modifying treatments are cumulative and increase over time; and (4) the different concepts of meaningfulness among key stakeholders. This review utilizes the future clinical biological framework of AD and aims to further integrate and expand the parameters of meaningful benefits toward a precision medicine framework. HIGHLIGHTS: Definition of meaningful benefit from Alzheimer's disease (AD) treatment varies across disease stage and stakeholder perspectives. Observable and meaningful outcomes must consider the clinical-biological nature of AD. Statistically significant effects or outcomes do not always equate to clinically meaningfulness. Assessment tools must reflect stage-specific subtle changes following treatment. Real-world evidence will support consensus, definition, and interpretation of clinical meaningfulness.

The impact of white matter hyperintensities on short-term outcomes of reperfusion therapy in patients with acute ischemic stroke.

This study aimed to explore the impact of white matter hyperintensities (WMH) on the short-term outcomes of reperfusion therapy in acute ischemic stroke (AIS) patients. We prospectively collected data on AIS patients undergoing reperfusion therapies at Chengdu Second People's Hospital from January 2020 and January 2024. WMH severity was graded as 0-3 (none to moderate) or 4-6 (severe) by the Fazekas scale. We analyzed National Institutes of Health Stroke Scale (NIHSS) scores, good functional outcomes (modified Rankin Scale, mRS 0-2) at 7days and discharge, and safety outcomes like in-hospital mortality and intracranial hemorrhage. During the study period, 669 patients were included, with 345 having none to moderate WMH and 324 with severe WMH. Patients with severe WMH exhibited significantly higher NIHSS and mRS at 7days and discharge, with a decrease in good outcomes (mRS 0-2: 40.43% vs. 75.65%), and an increase in intracranial hemorrhage (16.4% vs. 5.8%) and in-hospital mortality (11.7% vs. 2.0%) compared with none to moderate WMH patients. After matching the baseline data, none to moderate WMH was associated with higher likelihood of good outcomes at discharge [adjusted odds ratio (aOR), 2.142; 95% confidence interval (CI), 1.380-3.304; P < 0.001] and a lower rate of any intracranial hemorrhage (aOR, 0.348; 95% CI 0.180-0.673; P < 0.001), with no significant difference in in-hospital mortality between the groups. Severe WMH could reduce the benefits of reperfusion therapy in AIS, with increased risk of hemorrhagic complications, warranting further research into treatment strategies for these patients.

Efficacy and safety of Ranquilon® in the therapy of patients with anxiety associated with neurasthenia and adjustment disorder: results of the double-blind, randomized, placebo-controlled, multicenter phase 3 clinical trial

Objective: to evaluate the efficacy and safety of Ranquilon® (INN amide N-(6-phenylhexanoyl) glycyl-L-tryptophan)) tablets 1 mg2 at a dose of 6 mg per day (JSC “Valenta Pharm”, Russia) compared with placebo in the treatment of patients with anxiety in neurasthenia and adjustment disorder. Materialand methods. The clinical trial (CT) included a total of 220 patients with anxiety due to neurasthenia or adjustment disorder (adaptive reaction disorder) and a score on the Hamilton Anxiety Rating Scale (HARS) from 18 to 24 inclusive, the severity of asthenia on the self-assessment scale of asthenia (Multidimensional Fatigue Inventory, MFI-20) is more than 50 points, as well as at least 4 points on the severity subscale of the clinical global impression scale (Clinical Global Impression—Severity, CGI-S), who were randomly assigned to two groups and received double-blind treatment. Patients of group 1 (n=110) received Ranquilon® , 1 mg tablets, at a dose of 6 mg/day (2 tablets 3 times) for 28 days. Patients of group 2 (n=110) received PL in the same dosage regimen. The primary outcome measure for the clinical trial was the assessment of patient response rate (proportion of responders) as a ≥50% reduction in the mean total Hamilton Anxiety Rating Scale (HARS) score at Visit 3 (Day 29±1) compared to baseline at Visit 0 (days from -7 to -1). Secondary efficacy criteria included assessment of various parameters over time at visits 2 and 3 compared to the baseline (visit 0), in particular: on the HARS scale—the proportion of patients with a decrease in anxiety level (in the mean total score) by ≥50% and the proportion with ≤17 points, average anxiety score; for the CGI-I subscale—the proportion of patients with significant and pronounced improvement, on the CGI-S subscale—the proportion of patients with a score of 1 or 2 points, the mean total score of the change in the severity of the condition; on the MFI-20 scale—change in mean total score, the proportion of patients with a decrease in mean total score by 25%, by 50% and to ≤30 points, the mean total score for all subscale items; on the Spielberger-Hanin scale—change in the mean total score of personal anxiety and situational anxiety. To assess safety monitoring of adverse events (AEs), serious adverse events (SAEs), clinically significant deviations in vital signs, laboratory parameters, ECG parameters, etc. was analyzed. Results. The proportion of responders with a ≥50% reduction in HARS mean total score at Visit 3 (Day 29±1) compared to baseline (Visit 0) was statistically significantly higher (p&lt;0.0001) in in group 1 (Ranquilon® ) compared with group 2 (PL), respectively, was 70.0% (n=77) and 24.5% (n=27) (difference—45.5% (n =50)). Evaluation of all secondary efficacy criteria also showed a statistically significant benefit of therapy in Group 1 compared to Group 2 (p&gt;&lt;0.05). A total of 64 AEs were recorded in 44 (20.0%) patients: 43 AEs in 28 patients (25.5%) in Group 1 and 21 AEs in 16 (14.6%) patients in Group 2. There was no significant difference between treatment groups in the number of patients with AEs (p=0.063). In both groups, mild AEs were recorded; there were no patients with serious AEs (SAEs), SAEs with fatal outcome, or AEs that led to discontinuation of study therapy. No clinically significant abnormalities observed in vital signs, laboratory parameters, or ECG parameters. Conclusion. The superiority of Ranquilon® tablets 1 mg at a dose of 6 mg per day therapy over placebo in reducing anxiety in patients with conditions due to neurasthenia and adaptation disorder was confirmed. The drug demonstrated a favorable safety profile similar to that established for PL.&gt;&lt;0.0001) in in group 1 (Ranquilon® ) compared with group 2 (PL), respectively, was 70.0% (n=77) and 24.5% (n=27) (difference—45.5% (n =50)). Evaluation of all secondary efficacy criteria also showed a statistically significant benefit of therapy in Group 1 compared to Group 2 (p&lt;0.05).A total of 64 AEs were recorded in 44 (20.0%) patients: 43 AEs in 28 patients (25.5%) in Group 1 and 21 AEs in 16 (14.6%) patients in Group 2. There was no significant difference between treatment groups in the number of patients with AEs (p=0.063). In both groups, mild AEs were recorded; there were no patients with serious AEs (SAEs), SAEs with fatal outcome, or AEs that led to discontinuation of study therapy. No clinically significant abnormalities observed in vital signs, laboratory parameters, or ECG parameters. Conclusion. The superiority of Ranquilon® tablets 1 mg at a dose of 6 mg per day therapy over placebo in reducing anxiety in patients with conditions due to neurasthenia and adaptation disorder was confirmed. The drug demonstrated a favorable safety profile similar to that established for PL.

Exploring the Combined Efficacy of Rivastigmine and Vitamin E in Dementia Care

With the increasing number of individuals affected by dementia, particularly Alzheimer's disease (AD), it is essential to discover new treatments. This review looks at the potential benefits of using rivastigmine and vitamin E together to manage dementia. Rivastigmine, a drug that boosts acetylcholine levels in the brain, helps improve memory and communication between nerve cells. Vitamin E, a powerful antioxidant, shields brain cells from damage induced by oxidative stress. Combined, these treatments may slow down the progression of dementia and enhance patient outcomes. The review details how rivastigmine and vitamin E work individually and presents clinical evidence supporting their combined use. It also highlights the potential benefits of this combination therapy in improving cognitive functions and reducing the decline in daily activities. Additionally, the paper outlines areas for future research, such as long-term effectiveness, optimal dosages, and real-world application, to fully understand and utilize this therapeutic combination. In conclusion, while current evidence is promising, Additional research is required to validate the effectiveness and enhance the application of rivastigmine and vitamin E in dementia treatment. This review emphasizes the need for ongoing studies to refine treatment approaches and elevate the quality of life for individuals with dementia.

Benefits of Art therapy in Prison Population with a Diagnosis of Mental Illnes: A Systematic Review.

Art therapy is a form of psychotherapy that was introduced in psychiatric hospitals, where psychiatric patients used painting as a way to express themselves. Nowadays, it is used in prison and has positive effects such as stress and anxiety reduction, and decrease in rates of recidivism. The main aim of this study was to analyze the effects of art therapy programs among the prison population with a diagnosis of mental illness. A systematic review was performed and a total of 12 studies were included. Positive results and beneficial effects were observed for this population; the most prominent is the decrease in the rate of recidivism. Art therapy is a form of therapy that is effective for improving socialization and decreasing anxiety and depressive symptoms in patients diagnosed with mental illnesses. It has been proved to decrease recidivism rates in inmates who participate in these programs.

PDSS1 mutations-associated steroid-resistant nephrotic syndrome: case report and review of literature.

PDSS1 mutations hamper Coenzyme Q10 biosynthesis and cause a rare multisystem mitochondrial disease characterized by diverse clinical features and limited treatment options. To date, renal involvement has been reported in only one patient. We report a new female patient with compound heterozygous PDSS1 mutations and the clinical outcome following a trial of Coenzyme Q10 therapy. Our patient presented with developmental delay and regression at age three, which progressed to steroid-resistant nephrotic syndrome at age six, leading to stage 5 chronic kidney disease. Whole exome sequencing identified two pathogenic variants in the PDSS1 gene. High doses of Coenzyme Q10 therapy had no effect at this advanced stage of disease. Coenzyme Q10 treatment did not appear to improve the clinical outcome in this patient. Further data is needed to better understand the phenotypic spectrum of PDSS1-associated disruption, and the potential benefit of early Coenzyme Q10 therapy.

The effectiveness of music therapy for the treatment of Alzheimer's disease

Introduction: Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the most prevalent cause of dementia. It is caused by the degeneration of brain cells due to the accumulation of intracellular hyperphosphorylated tau - containing neurofibrillary tangles and extracellular plaques of amyloid-beta peptide. While pharmacotherapy remains the main form of treatment (including cholinesterase inhibitors and antagonists to NMDA), various non-pharmacological therapy modalities have gained increasing attention as complementary treatment options, such as music therapy. Purpose of the study: This review examines the role of music therapy as an important complement to baseline therapy for AD patients, focusing on indications, methods, and the prospect of music therapy. Materials and methods: A comprehensive literature review was conducted, analyzing 48 studies from the PubMed database (English-language, up to November 2024) that assess the efficacy, methods, and prospect of music therapy as an adjunctive therapy in Alzheimer’s disease. Conclusions: Music therapy is an established and effective supportive treatment for AD patients. It has demonstrated clinical success over many years as a tool for engaging multiple motor and sensory areas, shaping emotions, and evoking memories. This may be due to activating limbic and paralimbic structures, enhancing neuroplasticity, and modulating neurotransmitter systems. Despite the observable benefits of music therapy, the methodological limitations of existing studies highlight the need for further long-term research to standardize treatment approaches.

Leveraging Femtosecond Laser Ablation for Tunable Near-Infrared Optical Properties in MoS2-Gold Nanocomposites.

Transition metal dichalcogenides (TMDCs), particularly molybdenum disulfide (MoS2), have gained significant attention in the field of optoelectronics and photonics due to their unique electronic and optical properties. The integration of TMDCs with plasmonic materials allows to tailor the optical response and offers significant advantages for photonic applications. This study presents a novel approach to synthesize MoS2-Au nanocomposites utilizing femtosecond laser ablation in liquid to achieve tunable optical properties in the near-infrared (NIR) region. By adjusting ablation and fragmentation protocols, we successfully synthesize various core-shell and core-shell-satellite nanoparticle composites, such as MoS2/MoSxOy, MoSxOy/Au, and MoS2/MoSxOy/Au. UV-visible absorption spectroscopy unveils considerable changes in the optical response of the particles depending on the fabrication regime due to structural modifications. Hybrid nanoparticles exhibit enhanced photothermal properties when subjected to NIR-I laser irradiation, demonstrating potential benefits for selective photothermal therapy. Our findings underscore that the engineered nanocomposites not only facilitate green synthesis but also pave the way for tailored therapeutic applications, highlighting their role as promising candidates in the field of nanophotonics and cancer treatment.

Combination drug therapy in pulmonary hypertension: switch from selexipaq to intravenous trepostinil

A wide range of substances is currently available for the treatment of patients with pulmonary arterial hypertension. The current recommendations for initial drug therapy are based on the patient's risk profile. For patients at high risk, an initial triple combination therapy with different substances including prostanoids is recommended. The aim of the prospective, single-arm, unblinded study was to clarify whether PAH patients on triple therapy benefit from switching from selexipag to intravenous treprostinil. The primary endpoint was the achievement of a "low-risk" status after 6 (12) months. 27 PAH patients (45 (37; 61) years, 77.8% women) were included. At study entry they were assigned to low-risk (n=1), intermediate (n=12) or high-risk status (n=14). On average, 22 patients were followed for 8 (range 5-11) months. One patient was successfully transplanted after four months, another four patients died (in one case septic complications of unknown origin; in three cases progressive right heart failure). The primary endpoint (reaching "low-risk" status) was achieved in 12/21 (57.1%) patients (one further patient remained in "low-risk" status). These data indicate (despite the small number of patients) that even with established triple therapy, clinical improvement in individual patients is possible by switching from selexipag to intravenous treprostinil.

Differential long-term tamoxifen therapy benefit by menopausal status in breast cancer patients: secondary analysis of a controlled randomized clinical trial.

Estrogen receptor-positive breast cancer patients have a long-term risk of distant metastatic disease, and premenopausal patients have a higher risk. Randomized studies with long-term follow-up are essential to understand treatment benefit. We elucidated the long-term tamoxifen therapy benefit by menopausal status in the Stockholm tamoxifen trials with 20 years complete follow-up. Secondary analysis of 1242 estrogen receptor-positive and HER2-negative patients that were randomly assigned to 2-5 years of 40 mg adjuvant tamoxifen or no endocrine therapy. Distant recurrence-free interval in tamoxifen-treated vs endocrine untreated patients was assessed by Kaplan-Meier, Cox proportional hazards regression, and time-varying analyses. In premenopausal patients, a statistically significant tamoxifen benefit was observed for lymph node-negative (adjusted hazard ratio [HR] = 0.46, 95% confidence interval [CI] = 0.24 to 0.87), progesterone receptor-positive (adjusted HR = 0.61, 95% CI = 0.41 to 0.91), and genomic low-risk tumors (adjusted HR = 0.47, 95% CI = 0.26 to 0.85) but only lasted beyond 10 years for genomic low-risk tumors. Postmenopausal patients showed long-term benefit for all good-prognosis markers including low-grade (adjusted HR = 0.55, 95% CI = 0.41 to 0.73), lymph node-negative (adjusted HR = 0.44, 95% CI = 0.30 to 0.64), progesterone receptor-positive (adjusted HR = 0.60, 95% CI = 0.44 to 0.80), Ki-67 low (adjusted HR = 0.51, 95% CI = 0.38 to 0.68), and genomic low-risk tumors (adjusted HR = 0.53, 95% CI = 0.37 to 0.74), and regardless of tumor size (≤20 mm: adjusted HR = 0.55, 95% CI = 0.39 to 0.77; >20 mm: adjusted HR = 0.64, 95% CI = 0.44 to 0.94). Premenopausal patients with no poor-prognosis tumor characteristics (clinical marker score = 0) showed early benefit and postmenopausal long-term benefit. Our study suggests differential tamoxifen benefit by menopausal status. Improved long-term endocrine therapy prediction in premenopausal patients is needed and could involve molecular markers because standard tumor characteristics cannot predict benefit beyond 10 years.

Intrathecal baclofen pump for severe hypertonia in a patient with juvenile Huntington's disease: illustrative case.

While the symptoms of Huntington's disease (HD) typically first appear around the age of 40 years, 5%-10% of patients experience symptoms before the age of 21 years, in which case it is classified as juvenile Huntington's disease (JHD). JHD poses a unique clinical problem, as affected patients experience rapid deterioration in their quality of life as the motor manifestations of the disease become overwhelming. Medical treatment options for HD are sparse, and the only Food and Drug Administration-approved medication for the treatment of HD is the VMAT-2 inhibitor tetrabenazine. Unfortunately, treatments for JHD are even more limited, as investigational new drugs for HD oftentimes exclude patients with JHD from trials. Here, the authors present the case of a 15-year-old male with severe hypertonia and dystonic events secondary to JHD that was successfully treated with an intrathecal baclofen (ITB) pump. The patient experienced an improvement in hypertonia and a reduction in the frequency of dystonic events after ITB pump implantation, resulting in overall improved patient comfort. This case highlights the potential benefits of ITB therapy in managing debilitating hypertonia-type symptoms in patients with JHD. Given the limited treatment options for JHD, this intervention has the potential to profoundly enhance the quality of life for affected individuals. https://thejns.org/doi/10.3171/CASE24512.

Use Of Triple Therapy In A Cohort Of Patients With COPD Associated Wood Smoke And High Risk : Real Life Study Of Five Cases

Introduction: chronic obstructive pulmonary disease associated with exposure to wood smoke (copd-l) is part of 30% of the etiology of this entity. We know that copd-l has different characteristics compared to the association with tobacco. There is little worldwide experience in the use of bronchodilators and inhaled steroids in patients with this disease. Currently, the high risk of patients with copd-l is the main cause of exacerbations and shortterm cardiovascular outcome is the cause of increased morbidity and mortality. Triple therapy is currently a treatment used in patients with copd-t with excellent clinical and symptomatic benefits. Objective: to describe the effect of triple therapy in a series of 5 cases of patients with copd associated with wood smoke (copd-l) after 1-3-6 months of administration, improving symptoms and benefiting lung function. Methods: prospective, cross-sectional, observational real-life study carried out in the department of pulmonology of a third-level hospital in the city of puebla in the period from january 1, 2024 to august 1, 2024 in patients with symptomatic l-copd under the cat scale despite dual bronchodilator therapy treatment. Results: 100% of patients were female, exposed to wood smoke with an average of 196 hours/year, eosinophil count of 338 cells on average, with cat starting greater than 24 points before treatment and 13 points at the end of treatment at 6 months. Decrease to 50% of the eosinophil count, as well as decrease in dyspnea 1 point on the mmrc scale and 5 points on the borg scale. Conclusion: the cases described offer initial evidence of our medical practice on the benefits of triple therapy in patients with copd associated with firewood. Beclomethasone/formoterol/glycopyrronium have demonstrated good tolerance and safety without presenting adverse effects. These benefits have allowed the patient a better quality of life and a radical decrease in the prevalence of symptoms.

The Impact of Historical Art Movements on Medicine

Art and medicine have long influenced one another, with historical art movements shaping not only aesthetic trends but also conceptions of health, disease, and human anatomy. This paper examines the intertwined evolution of art and medicine across pivotal historical periods, highlighting the Renaissance’s focus on anatomical accuracy, Romanticism’s emotional engagement with the human condition, and Modernism’s reflection of trauma from warfare and disease. The analysis considers how visual representations, from anatomical sketches to symbolic portrayals of illness, have impacted public health perceptions and medical education. Additionally, the study examines the therapeutic uses of art in contemporary settings, underscoring the psychological benefits of art therapy in clinical care. By tracing these influences, this paper sheds light on art’s role in shaping healthcare practices, patient experience, and medical ethics, while advocating for continued interdisciplinary collaboration to enhance medical humanities and patient-centered care. Keywords: Art and Medicine, Historical Art Movements, Renaissance Anatomy, Modernism and Trauma, Art Therapy.

CRISPR/Cas9 Gene Editing: A Novel Approach Towards Alzheimer's Disease Treatment.

In defiance of the vast amount of information regarding Alzheimer's disease (AD) that has been learned over the past thirty years, progress toward developing an effective therapy has been difficult. A neurological ailment that progresses and cannot be reversed is Alzheimer's disease, which shows neurofibrillary tangles, beta-amyloid plaque, and a lack of cognitive processes that is created by tau protein clumps with hyperphosphorylation that finally advances to neuronal damage without a recognized treatment, which has stimulated research into new therapeutic strategies. The protein CAS9 is linked to CRISPR, which is a clustered Regularly Interspaced Short Palindromic Repeat that inactivates or corrects a gene by recognizing a gene sequence that produces a doublestranded break has enchanted a whole amount of interest towards its potency to cure gene sequences in AD. The novel CRISPR-Cas9 applications for developing in vitro and in vivo models to the benefit of AD investigation and therapies are thoroughly analyzed in this work. The discussion will also touch on the creation of delivery methods, which is a significant obstacle to the therapeutic use of CRISPR/Cas9 technology. By concentrating on specific genes, such as those that are significant early- onset AD risk factors and late-onset AD risk factors, like the apolipoprotein E4 (APOE4) gene, this study aims to evaluate the potential application of CRISPR/Cas9 as a possible treatment for AD.

The genetics workforce must be addressed before we can realize the benefits of gene therapy.

The genetics workforce must be addressed before we can realize the benefits of gene therapy.

Updated Genetic Analysis of Japanese Familial ALS Patients Carrying SOD1 Variants Revealed Phenotypic Differences for Common Variants.

Amyotrophic lateral sclerosis (ALS) is an adult-onset progressive neurodegenerative disease. Approximately 10% of ALS cases are familial, and more than 20 causative genes have been identified. As we have previously reported, SOD1 variants are the most common causes of familial ALS in Japan. Because antisense oligonucleotides for SOD1-linked ALS are being used in practical applications, the types of variants and the clinical features of patients need to be updated. We consecutively recruited 160 families with familial ALS in Japan. We performed genetic analyses, focusing on SOD1-linked ALS as the most common in our cohort, updated their genotypes, and characterized clinical phenotypes. A total of 26 SOD1 variants in 56 patients and 49 families (30.6%) were collected, with the 3 most common (p.His47Arg [the conventional numbering; H46R], p.Leu127Ser [L126S], p.Asn87Ser [N86S]) accounting for 38.8% of all families. We also identified 2 novel variants (p.Ile36Phe [I35F] and p.Asn132Argfs*3 [N131Rfs*3]). The mean age at onset was 48.9 ± 12.2 (mean ± SD) years for all patients with SOD1-linked ALS. Lower limb onset comprised 70% of cases. The mean disease duration was 64.7 ± 82 months, and the median survival was 71.5 months. Some variants led to a relatively homogeneous phenotype, although clinical characteristics differed among types of variants and families. Patients with p.His47Arg (H46R) showed slower progression with lower limb onset and a predominance of lower motor neuron involvement. The p.Leu127Ser (L126S) variant led to varying degrees of progression in heterozygous or homozygous states and presented incomplete penetrance. Intrafamilial phenotypic differences were observed in families carrying p.Asn87Ser (N86S). Four variants (p.Cys7Gly [C6G], p.His44Arg [H43R], p.Leu85Val [L84V], and p.Cys147Arg [C146R]) were found to be associated with rapid disease progression. The genetic basis of familial ALS, at least for SOD1 variants, still differed by geographic and ethnic background. Understanding these clinical profiles will help optimize evaluation in targeted gene therapy worldwide and benefit efficient diagnosis, leading to precise application in clinical practice.

Cost-utility of Pilates versus home-based exercises in individuals with chronic non-specific low back pain: economic evaluation alongside a randomised controlled trial

IntroductionChronic non-specific low back pain (CNLBP) is a major cause of disability resulting in high healthcare and lost productivity costs worldwide. Exercise therapy is the most prescribed treatment for CNLBP worldwide. Despite the benefits of exercise therapy, systematic reviews have highlighted the need for further high-quality evidence regarding their (cost-)effectiveness related to alternative treatments such as Pilates. Therefore, the aim was to investigate the cost-effectiveness of Pilates compared with home-based exercises for CNLBP.

The efficacy of negative-pressure wound therapy (NPWT) in the prevention of surgical site occurrences in open abdominal surgery: A randomized clinical trial

BackgroundThe secondary consequences of surgical site occurrences, especially surgical site infections, worsen the patient's outcomes while significantly increasing health care costs. The implementation of preventive measures to reduce this complication rate should be one of the priorities to improve health care. MethodsA randomized, open-label clinical trial was conducted between March 2019 and March 2021 in a general surgery department. Individuals who had undergone laparotomy and had risk factors for developing surgical site infections and surgical site occurrences were included and randomized to use either negative-pressure wound therapy or conventional dressing (control group) on the closed surgical incision. The aim of our study was to evaluate the benefit of negative-pressure wound therapy in the surgical site infection rates and other surgical site occurrences in both groups at a 30-day follow-up. ResultsTwo hundred seventy-five participants were recruited and were analyzed, 147 (53.5%) in the negative-pressure wound therapy group and 128 (46.5%) in the control group. Thirty-one (11.3%) surgical site infections and 71 (25.8%) other surgical site occurrences were observed, being significantly lower in the negative-pressure wound therapy group (odds ratio 0.31, 95% confidence interval 0.14–0.71; P = .005) and (odds ratio 0.51, 95% confidence interval 0.29–0.90; P = .02), respectively. Absolute risk reduction was 13% for surgical site infection and 12% for other surgical site occurrences. Number needed to treat 9 (95% confidence interval 5–29) for surgical site infection and number needed to treat of 8 (95% confidence interval 5–51) for other surgical site occurrences. Median hospital stay was 3 days lower in the negative-pressure wound therapy group than in the control group (9 vs 12 days; P = .03). No severe adverse events attributable to the negative-pressure wound therapy dressing were reported. ConclusionNegative-pressure wound therapy decreases the risk of surgical site occurrences and surgical site infection after laparotomy, so that its use should be considered in patients with risk factors.

Benefit of early oseltamivir therapy for adults hospitalized with influenza A: an observational study.

clinical guidelines recommend initiation of antiviral therapy as soon as possible for patients hospitalized with confirmed or suspected influenza. A multicenter US observational sentinel surveillance network prospectively enrolled adults (aged ≥18 years) hospitalized with laboratory-confirmed influenza at 24 hospitals during October 1, 2022-July 21, 2023. A multivariable proportional odds model was used to compare peak pulmonary disease severity (no oxygen support, standard supplemental oxygen, high-flow oxygen/non-invasive ventilation, invasive mechanical ventilation, or death) after the day of hospital admission among patients starting oseltamivir treatment on the day of admission (early) versus those who did not (late or not treated), adjusting for baseline (admission day) severity, age, sex, site, and vaccination status. Multivariable logistic regression models were used to evaluate the odds of intensive care unit (ICU) admission, acute kidney replacement therapy or vasopressor use, and in-hospital death. A total of 840 influenza-positive patients were analyzed, including 415 (49%) who started oseltamivir treatment on the day of admission, and 425 (51%) who did not. Compared with late or not treated patients, those treated early had lower peak pulmonary disease severity (proportional aOR: 0.60, 95% CI: 0.49-0.72), and lower odds of intensive care unit admission (aOR: 0.24, 95% CI: 0.13-0.47), acute kidney replacement therapy or vasopressor use (aOR: 0.40, 95% CI: 0.22-0.67), and in-hospital death (aOR: 0.36, 95% CI: 0.18-0.72). Among adults hospitalized with influenza, treatment with oseltamivir on day of hospital admission was associated reduced risk of disease progression, including pulmonary and extrapulmonary organ failure and death.

Selection of Patients With Early-Stage Breast Cancer for Extended Endocrine Therapy

There is a need for biomarkers that predict late recurrence risk and extended endocrine therapy (EET) benefit among patients with early-stage breast cancer (EBC). MammaPrint, a 70-gene expression risk-of-recurrence assay, has been found to project significant EET benefit in patients with assay-classified low-risk tumors. To determine the test's utility in identifying which patients with EBC in the IDEAL (Investigation on the Duration of Extended Adjuvant Letrozole) trial could benefit from 5-year vs 2.5-year letrozole treatment. This secondary analysis of the IDEAL randomized clinical trial evaluated postmenopausal women with hormone receptor-positive EBC who were assigned to either 2.5 or 5 years of EET, with 10 years of follow-up after randomization. A 70-gene assay was used to classify tumors as high, low, or ultralow risk. Adverse event (AE) frequency and treatment compliance were evaluated. Statistical analyses were performed from April 2022 to September 2024. After 5 years of endocrine therapy, patients were randomized to 2.5 or 5 years of EET with letrozole. Primary end point was distant recurrence (DR). Cox proportional hazard regression models and likelihood ratios tested the interaction between treatment and gene expression assay. Among 515 women included (mean [SD] age at randomization, 59.9 [9.5] years), 265 were in the 2.5-year treatment arm and 250 in the 5-year treatment arm. Of these patients, 223 (43.3%) patients with 70-gene assay-classified low-risk tumors had a significant absolute benefit of 10.1% for DR (hazard ratio, 0.32; 95% CI, 0.12-0.87; P = .03). Treatment interaction was not significant for DR. Of patients with either 70-gene assay-classified high-risk tumors (259 [50.3%]) or ultralow risk tumors (33 [6.4%]), 5 years vs 2.5 years of EET was not associated with improved benefit for DR. As expected, rates of AEs and treatment discontinuation were comparable among the different 70-gene assay risk groups in each treatment arm. This secondary analysis of the IDEAL trial found that the 70-gene assay identified patients with low-risk tumors who could benefit from 5-year vs 2.5-year EET. These findings suggest that this gene expression assay could go beyond guiding neoadjuvant and adjuvant chemotherapy decisions to informing the optimal duration of adjuvant endocrine therapy. EU Clinical Trials Register Eudra CT: 2006-003958-16.