Standard Of Care Research Articles

Patient perspectives on multidimensional learning and person-centred care: interviews with persons living with type 2 diabetes.

The objective of this study was to explore patients' learning and support needs within contemporary diabetes care to help them deal with daily life challenges. A qualitative descriptive design was used following the Consolidated Criteria for Reporting Qualitative Studies. The 15 individual face-to-face interviews were analysed using qualitative content analysis. Participants were drawn from three healthcare centres in rural and urban regions of West Sweden. The study involved 15 patients (8 men, 7 women) with T2DM who experienced contemporary diabetes care. Patients expressed a strong desire for access to person-centred, multidimensional learning, with a focus on genuine partnership, tailored education, and emotional engagement. Digital tools were seen as valuable aids in their self-care efforts. Sub-themes were 'Desiring genuine partnership and tailored patient education' and 'Needing support related to altered perspectives on life and awareness of care standards but with finite care resources'. The findings suggest that integrating person-centred, multidimensional learning strategies into diabetes care could be beneficial, particularly when addressing both practical and emotional needs. Encouraging active patient engagement through flexible digital solutions and providing support for emotional well-being may improve the overall patient experience. However, further research and practical application are needed to fully understand how these strategies could be effectively implemented to support patients with T2DM in managing their daily health challenges.

Family Nurture Intervention and mother-preterm infant autonomic emotional connection in the neonatal intensive care unit: A review.

We review methods and outcomes of a novel parenting intervention, Family Nurture Intervention (FNI), that promotes early mother-infant autonomic co-regulation and emotional connection in the neonatal intensive care unit (NICU). FNI involves individualised mother-infant calming sessions combined with maternal emotional expression. Two parallel group randomised controlled trials have evaluated FNI. The first,recruited 150 preterm newborns (26-34 weeks GA) and their mothers, randomised into two groups: FNI (n = 78) and Standard Care (SC) only (n = 72). Dyadic, infant and maternal outcomes were assessed at discharge, 18-months and 4-5 years corrected age. The second,recruited 135 infants from two level 4 NICUs (FNI n = 66, SC n = 69) with similar outcomes assessed at discharge/term equivalent. Relative to SC, FNI infants showed improved development and relational health through 5 years. At term age, FNI infants had better autonomic regulation and more mature brain activity and cortical connectivity on EEG. FNI mothers also reported fewer anxiety and depression symptoms post-discharge. At 18-month, FNI infants obtained higher cognitive and language scores, and lower attention and social behaviour scores than SC infants. FNI improves the early life development and relational health of high-risk preterm infants. Further research is important to assess its efficacy in other high-risk populations and contexts.

Protocol for a Randomized Controlled Trial on the Development and Effectiveness of an Educational Mobile Application Using an Integrated Change Model to Prevent Atherosclerotic Cardiovascular Disease Risk Factors

Background: An effective approach to preventing cardiovascular issues is the use of mobile health applications to improve modifiable risk factors. This protocol for a randomized controlled trial aims to evaluate the development and effectiveness of an educational mobile app that employs an integrated change model to reduce risk factors for atherosclerotic cardiovascular disease (ASCVD) among individuals aged 20 to 69 years. Methods: This study will be a parallel, randomized, single-blind clinical trial utilizing the randomized block design involving 430 participants. The participants will be divided into a control group receiving standard clinical care and an intervention group receiving standard clinical care along with app-based education, over approximately 6 months. Conclusion: This application has been designed to enhance motivation, awareness, and positive habits to reduce risk factors in individuals at increased risk of ASCVD. Consequently, the results could improve cardiovascular health knowledge, manage biological risk factors, and modify cardiac behaviors through mobile applications. This research is expected to present a promising approach to utilizing mobile apps for managing cardiovascular health and contribute to the growing body of research on digital health interventions.

Effect of preoperative inspiratory muscle training combined with preoperative education on postoperative pulmonary complications in high-risk patients with lung cancer: protocol for a randomised controlled trial.

Preoperative inspiratory muscle training (IMT) is recognised as an important component of the preoperative management of lung cancer, although there is limited evidence for the delivery of a home-based IMT programme combined with preoperative education. We developed a programme combining short-term home-based IMT and preoperative physiotherapy education ('the programme'). This study aims to evaluate the effectiveness of this programme in reducing postoperative pulmonary complications (PPCs) after lung cancer resection compared with standard care. In this randomised controlled trial, 114 participants scheduled for lung cancer surgery at the First Affiliated Hospital of Fujian Medical University will be randomly assigned (1:1) to either receive usual care (information booklet) or usual care combined with the programme, which consist of short-term home-based IMT and preoperative physiotherapy education. The primary outcome measure will be PPCs using the Melbourne Group Score. Secondary outcomes will include health-related quality of life, maximal inspiratory pressure, 6 min walk distance, length of hospital stay, anxiety and depression levels, and hospital costs. The study has received ethics approval from the ethics committee of the first affiliated hospital of Fujian Medical University (approval no: MRCTA, ECFAH of MFU [2021]569). Participants will be required to provide written informed consent. The results of the study will be submitted for publication in peer-reviewed journals. ChiCTR2300067464.

Positioning Ethics When Direct Patient Care is Prioritized: Experiences from Implementing Ethics Case Reflection Rounds in Childhood Cancer Care.

Caring for children with cancer involves complex ethical challenges. Ethics Case Reflection (ECR) rounds can be offered to support teams to reflect on challenges and what should be done in patient care. A training course, for facilitators of ECR rounds, has been offered to healthcare professionals (HCPs) in childhood cancer care by a Nordic working group on ethics. During/after the course, the trainees implemented and facilitated ECR rounds in their clinical setting. The aim was to explore the trainees' experiences of implementing ECR rounds in childhood cancer care. HCPs, who participated as trainees in the course, participated in 3 focus group interviews (n = 22) and 27 individual interviews (n = 17). Interview data were analysed concurrently with data collection following classic grounded theory. Positioning ethics is the core category in this study, used to resolve the main concern of doing ethics in a context where direct patient care is prioritized. Being able to take time for ethics reflections, not perceived as the key priority, was considered a luxury in the clinical setting. Strategies for positioning ethics include allying, promoting ethics reflection, scheduling ethics reflection, and identifying ethical dilemmas. These strategies can be more or less successful and vary in intensity. The prioritisation of direct patient care is not surprising, but polarisation between care and ethics needs to be questioned and ethics reflection need to be integrated in standard care. Ethical competence seems to be central in doing ethics and more knowledge on the promotion of ethical competence in practice and education is needed.

The importance of simultaneous oculoplastic surgery in quality of life related to vision in surgical resection of large vestibular schwannomas.

Facial nerve palsy is one of the most important complications of vestibular schwannoma resection. When VII cranial nerve is damaged, ocular complications might appear, impacting patient´s quality of life. Therefore, standardized eye care must be a priority. This involves three key treatments: topical treatment, rehabilitation and oculoplastic surgery. The aim of this work is to review the results of oculoplastic surgery performed simultaneously with vestibular schwannoma resection in terms of vision-related quality of life, compared to deferred surgery. The study involved 177 patients who underwent vestibular schwannoma resection between 2015 and 2022. The incidence of facial palsy was registered. Of those patients who had the palsy, we selected 35 who also had oculoplastic surgery. 5 of them declined participating in the study. The final sample (n = 30) was divided in two groups depending on the timing of oculoplastic surgery: simultaneously- first group (n = 15) and deferred-second group (n = 15). The vision-related quality of life was measured using the NEI VFQ-25 test. 26.56% patients developed an immediate postoperative facial dysfunction, decreasing to 18.08% after one year of follow-up. Timing of oculoplastic surgery was associated with better results in quality of life; the first group of patients had a better quality of life (70.27/100) compared to the second group (53.73/100; p = 0.006). Moreover, worse results in quality of life were also associated with long-term postoperative facial palsy (p = 0.042). Current criteria for selecting patients were reliable, proving adequacy as we found worse long-term facial functions in patients who underwent simultaneous surgery (p = 0.01). Our current criteria for selecting candidates for simultaneous oculoplastic surgery are effective. When long-term facial nerve dysfunction is expected during vestibular schwannoma resection, oculoplastic surgery should be performed simultaneously to preserve the q vision-related quality of life. Long-term severe facial palsy is associated with poor vision-related quality of life.

Shared decision making in primary malignant bone tumour surgery around the knee in children and young adults: protocol for a prospective study

BackgroundChildren and young adults needing surgery for a primary malignant bone tumour around the knee face a difficult, life-changing decision. A previous study showed that this population wants to be involved more in the decision-making process and that more involvement leads to less decisional stress and regret. Therefore, a well-designed and standardized decision-making process based on the principles of shared decision-making needs to be designed, implemented, and evaluated.MethodsWe developed a shared decision-making (SDM) model for this patient population, including an online decision aid (DA). This model has been implemented in the standard care of patients with a primary malignant bone tumour around the knee. Following implementation, we will analyse its effect on the decision-making process and the impact on patient experiences using questionnaires and interviews. Moreover, potential areas for improvement will be identified.DiscussionGiven the importance of involving patients and parents in surgical decision-making, particularly in life-changing surgery such as malignant bone tumour surgery, and given the lack of SDM models applicable for this purpose, we want to share our model with the international community, including our study protocol for evaluating and optimising the model. This study will generate valuable knowledge to facilitate the optimisation of current patient care for local treatment. The sharing of our implementation and study protocol can serve as an example for other centres interested in implementing SDM methods in an era characterized by more empowered patients and parents who desire autonomy and reliable and realistic information.

Multivariable models of outcomes with [177Lu]Lu-PSMA-617: analysis of the phase 3 VISION trial

[177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolonged life in patients with metastatic castration-resistant prostate cancer (mCRPC) in VISION (NCT03511664). However, distinguishing between patients likely and unlikely to respond remains a clinical challenge. We present the first multivariable models of outcomes with 177Lu-PSMA-617 built using data from VISION, a large prospective phase 3 clinical trial powered for overall survival. Adults with progressive post androgen receptor pathway inhibitor and taxane prostate-specific membrane antigen (PSMA)-positive mCRPC received 177Lu-PSMA-617 plus protocol-permitted standard of care (SoC) or SoC alone. In this post hoc analysis, multivariable Cox proportional hazards models of overall survival (OS) and radiographic progression-free survival (rPFS), and a logistic regression model of prostate-specific antigen response (≥50% decline; PSA50) were constructed and evaluated using C-index or receiver operating characteristic (ROC) analyses with bootstrapping validation. Nomograms were constructed for visualisation. Patients were randomised between June 2018 and October 2019. Data from all 551 patients in the 177Lu-PSMA-617 arm were analysed in multivariable modelling. The OS nomogram (C-index, 0.73; 95% confidence interval [CI], 0.70-0.76) included whole-body maximum standardised uptake value (SUVmax), time since diagnosis, opioid analgesic use, aspartate aminotransferase, haemoglobin, lymphocyte count, presence of PSMA-positive lesions in lymph nodes, lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and neutrophil count. The rPFS nomogram (C-index, 0.68; 0.65-0.72) included SUVmax, time since diagnosis, opioid analgesic use, lymphocyte count, presence of liver metastases by computed tomography, LDH, and ALP. The PSA50 nomogram (area under ROC curve, 0.72; 95% CI, 0.68-0.77) included SUVmax, lymphocyte count and ALP. Performances of the OS and rPFS models were maintained when they were reconstructed excluding SUVmax. These models of outcomes with 177Lu-PSMA-617 are the first built using prospective phase 3 data. They show that a combination of pretreatment laboratory, clinical, and imaging parameters, reflecting both patient and tumour status, influences outcomes. These models are important for aiding treatment selection, patient management, and clinical trial design. Novartis.

Protocol for a randomized controlled trial to evaluate the effectiveness of a telehealth group intervention to reduce perinatal depressive symptoms

BackgroundPerinatal depression and anxiety (PDA) affect approximately 20 % of individuals and are associated with adverse outcomes, including preterm birth, low birth weight, and impaired cognitive development of the child. Telehealth may reduce access barriers to needed mental health services. However, lack of disseminated, standardized study protocols aimed at investigating the role of telehealth in reducing PDA symptoms limits the ability to compare findings across studies. The purpose of this paper is to provide a conceptual framework and a randomized controlled trial protocol (RCT) for use in future studies. Methods and analysisAn RCT was designed to evaluate the effectiveness of a group videoconference intervention (VCI) to reduce PDA symptoms across pregnancy and postpartum period. Participants are randomly assigned to study groups: VCI + standard of care, or attention control (AC) + standard of care. Both groups have weekly one-hour group videoconference sessions for 9 weeks. The VCI groups are facilitated by a mental health professional using a manualized program based on mindfulness-based practices and cognitive behavioral therapy (MBCT). The AC groups are facilitated by a registered nurse using a manualized program for childbirth and parenting education. The primary outcomes are depressive symptoms as measured by the Edinburgh Postnatal Depression Scale (EPDS) and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7). ConclusionThis RCT study protocol can be used as a standard approach to improve the ability to compare findings across studies, applied in any setting (e.g., rural or urban), and adapted to diverse communities.Trial Registration:ClinicalTrials.govNCT03932760

Traditional, complementary and integrative medicine therapies for the treatment of mild/moderate acute COVID-19: protocol for a systematic review and network meta-analysis

BackgroundIncreasing evidence has emerged for traditional, complementary and integrative medicine (TCIM) to treat COVID-19 which requires systematic summaries of the net benefits of interventions against standard care and one another....

A Hybrid Simulation‐Based Workshop Improves Knowledge and Confidence in the Management of Hemorrhagic Conversion of Stroke Among Interventional Neurology Trainees

Background Mechanical thrombectomy is the standard of care in acute ischemic stroke with anterior large vessel occlusion presenting within 6 hours of symptom onset, but complications do exist. We assessed the feasibility of a hybrid simulation‐based workshop at a national meeting for interventional neurology trainees focused on the management of acute ischemic stroke and tissue‐plasminogen activator‐related hemorrhage. Methods In this prospective, observational, hybrid simulation‐based study at a fellows’ workshop at a national conference, participants were asked to manage a patient with acute ischemic stroke in the neurointerventional suite followed by thrombolytic‐related hemorrhage leading to cerebral herniation during mechanical thrombectomy. We evaluated the participants’ ability to complete critical actions that were developed based on best practices and relevant American Heart Association guidelines and the Neurocritical Care Society's Emergency Neurological Life Support protocols. The primary outcome was the improvement in knowledge from a precourse to postcourse test. Secondary outcomes included participant reactions. Results Sixty trainees completed the simulation session in 8 groups. The mean sum of critical actions completed by trainees was 9.75/14 (70%). There was a moderate effect of the intervention on trainees’ knowledge from pretest (mean 3.8, SD = 0.3) to posttest (mean 4.3, SD = 0.3). The simulation scenario was described as moderately realistic, very engaging, and extremely satisfactory. Following the workshop, all fellows endorsed an increase in proficiency and confidence in neurological emergency management. Conclusion Simulation‐based workshops at national conferences are feasible and a potentially useful tool for safely educating a large audience of trainees who may not have access to high‐fidelity simulation platforms at their institutions.

Recurrent peritonsillar abscess in adults: Incidence and risk factors in a prospective longitudinal cohort

ObjectiveThe incidence of recurrent peritonsillar abscess (7.4–22%) was estimated in retrospective studies. The aim of this prospective study was to estimate the cumulative incidence of recurrent peritonsillar abscess and related risk factors. MethodsWe performed a prospective longitudinal cohort study. The study included adult patients (≥18 years old) of both sexes who were attended in the emergency facilities of our tertiary hospital, without peritonsillar abscess background, diagnosed of a first episode of peritonsillar abscess and treated with standard of care (abscess drainage and antibiotics). Patients were followed for 24 months. Cumulative incidence of peritonsillar abscess recurrence was estimated and its 95% confidence interval was calculated; and predictive risk factors were assessed. ResultsBetween January 1st, 2019 and March 9th, 2020, a total of 181 consecutive patients were included. The cumulative incidence of recurrent peritonsillar abscess at 2 years of the diagnosis was 9.9% (18 out of 181, 95% CI: 6.4–15.2%). The only risk factor associated with recurrent peritonsillar abscess in multivariate analysis was low plasma glucose level at the time of emergency room attendance (HR: 0.46, 95% CI: 0.24–0.91, p-value: 0.026). ConclusionPeritonsillar abscess is an incident medical issue, with an established recurrence rate, but with unclear predictive risk factors of recurrence. Further studies are needed to assess the risk factor associated with recurrent peritonsillar abscess.

Comparison of first-line chemotherapy regimens in unresectable locally advanced or metastatic pancreatic cancer: a systematic review and Bayesian network meta-analysis

In advanced pancreatic ductal adenocarcinoma (PDAC), first-line chemotherapy is the standard of care. Due to the absence of head-to-head comparisons in clinical trials, we performed this systematic review and network meta-analysis to compare treatment options for PDAC in terms of their efficacy and toxicity. PubMed, the Cochrane Central Register of Controlled Trials, Embase, and oncological meetings websites were searched until Nov 15, 2023. We included phase 2-3 randomised controlled trials published after Jan 1, 2000, evaluating first-line treatments in patients with previously untreated, unresectable, locally advanced or metastatic PDAC. Primary endpoints assessed were progression-free survival and overall survival. Summary data were extracted from published reports. The deviance information criterion was used to choose between a random-effects or fixed-effects model. Hazard ratios (HRs) with 95% credible intervals were estimated using a Bayesian approach. The risk of bias was evaluated using the Cochrane Risk of Bias 2 (RoB 2) tool and studies were graded as low, some concerns, or high risk of bias. The quality of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. This systematic review and network meta-analysis is registered with PROSPERO, CRD42023450330. 6050 records were screened and 79 randomised controlled trials (22 168 patients) were included in the analysis. Gemcitabine was the most frequent comparator (in 50 [63%] of 79 trials) and was considered as the reference treatment. A fixed-effect model was used to analyse the primary outcomes. Regarding progression-free survival (71 trials, 19 479 patients), the most effective treatments were gemcitabine plus nab-paclitaxel alternating folinic acid, fluorouracil, and oxaliplatin ([FOLFOX] HR 0·32, 95% credible interval 0·22-0·47), cisplatin, nab-paclitaxel, capecitabine, and gemcitabine ([PAXG] 0·35, 0·22-0·55), and liposomal irinotecan in combination with fluorouracil, leucovorin, and oxaliplatin ([NALIRIFOX] 0·43, 0·34-0·54), followed by fluorouracil, leucovorin, irinotecan, and oxaliplatin ([FOLFIRINOX] 0·55, 0·47-0·65) and gemcitabine plus nab-paclitaxel (0·62, 0·54-0·72). Similar results were observed for overall survival (79 trials, 22 104 patients): PAXG (HR 0·40, 95% credible interval 0·25-0·65), gemcitabine plus nab-paclitaxel alternating FOLFOX (0·46, 0·32-0·66), and NALIRIFOX (0·56, 0·45-0·70) had the highest benefit, followed by FOLFIRINOX (0·66, 0·56-0·78) and gemcitabine plus nab-paclitaxel (0·67, 0·59-0·77). The overall risk of bias was low to some concerns. Certainty of evidence was low. Our findings suggest that NALIRIFOX and FOLFIRINOX should be the preferred options for patients who can tolerate these regimens, with gemcitabine plus nab-paclitaxel remaining a viable alternative, particularly in patients unfit for triplet therapy. Phase 3 randomised controlled trials investigating concomitant or sequential quadruplets are warranted. None.

Atezolizumab/bevacizumab and lenvatinib for hepatocellular carcinoma: A comparative analysis in a European real-world cohort.

Immunotherapy-based combinations are currently the standard of care in the systemic treatment of patients with HCC. Recent studies have reported unexpectedly long survival with lenvatinib (LEN), supporting its use in first-line treatment for HCC. This study aims to compare the real-world effectiveness of LEN to atezolizumab/bevacizumab (AZ/BV). A retrospective analysis was conducted to evaluate the effectiveness and safety of frontline AZ/BV or LEN therapy in patients with advanced HCC across 18 university hospitals in Europe. The study included 412 patients (AZ/BV: n=207; LEN: n=205). Baseline characteristics were comparable between the 2 treatment groups. However, patients treated with AZ/BV had a significantly longer median progression-free survival compared to those receiving LEN. The risk of hepatic decompensation was significantly higher in patients with impaired baseline liver function (albumin-bilirubin [ALBI] grade 2) treated with AZ/BV compared to those with preserved liver function. Patients with alcohol-associated liver disease had poorer baseline liver function compared to other etiologies and exhibited a worse outcome under AZ/BV. In this real-world cohort, survival rates were similar between patients treated with LEN and those treated with AZ/BV, confirming that both are viable first-line options for HCC. The increased risk of hepatic decompensation in patients treated with AZ/BV who have impaired baseline liver function underscores the need for careful monitoring. Future trials should aim to distinguish more clearly between metabolic dysfunction-associated steatotic liver disease and alcohol-associated liver disease.

Navigating the changing landscape of BTK-targeted therapies for B cell lymphomas and chronic lymphocytic leukaemia.

The B cell receptor (BCR) signalling pathway has an integral role in the pathogenesis of many B cell malignancies, including chronic lymphocytic leukaemia, mantle cell lymphoma, diffuse large B cell lymphoma and Waldenström macroglobulinaemia. Bruton tyrosine kinase (BTK) is a key node mediating signal transduction downstream of the BCR.The advent of BTK inhibitors has revolutionized the treatment landscape of B cell malignancies, with these agents often replacing highly intensive and toxic chemoimmunotherapy regimens as the standard of care. In this Review, we discuss the pivotal trials that have led to the approval of various covalent BTK inhibitors, the current treatment indications for these agents and mechanisms of resistance. In addition, we discuss novel BTK-targeted therapies, including covalent, as well as non-covalent, BTK inhibitors, BTK degraders and combination doublet and triplet regimens, to provide insights on the best current treatment paradigms in the frontline setting and at disease relapse.

Effect of individualized anesthesia and analgesia on postoperative pain in patients stratified for pain sensitivity: A study protocol for the PeriOPerative individualization trial randomized controlled trial.

Despite advancements in surgical and anesthesia techniques, acute and persistent postoperative pain are still a common challenge. Postoperative pain has direct effects on individual patient care and outcome, as well as putting strain on limited health care resources. Several prediction methods for postoperative pain have been described. One such method is the assessment of pain during peripheral venous cannulation (VCP). It is not known if different approaches to anesthesia and analgesia, depending on the evaluation of risk for postoperative pain, can improve outcome. The aim of this study is to evaluate if individualized anesthesia and analgesia can affect postoperative pain and recovery after surgery, in patients stratified by VCP. Adult patients scheduled for laparoscopic surgery undergo pain-sensitivity stratification using VCP on the day of surgery. Patients scoring VCP ≥2.0 on the visual analogue scale (pain-sensitive) are randomized to multimodal anaesthesia and analgesia with opioids or standard of care. Patients scoring VCP ≤1.9 (pain-tolerant) are randomized to opioid-free anaesthesia or standard of care. The primary outcome is acute postoperative pain measured with numeric rating scale in the postoperative care unit. Secondary outcomes include analysis of pain after 24 h, persistent postoperative pain and quality of recovery. Individualized perioperative pain management has the potential to improve patient care. This study will examine the impact of different anesthesia and analgesia regimes, in patients with differing pain sensitivity, on postoperative pain. Prospectively posted at ClinicalTrials.gov, identifier NCT04751812.

A Randomized Study of Cryoablation of Intercostal Nerves in Patients Undergoing Minimally Invasive Thoracic Surgery

ObjectivesMinimally invasive thoracic surgery can cause significant pain, and optimizing pain control after surgery is highly desirable. We examined pain control after intercostal nerve block with or without cryo-ablation of the intercostal nerves. MethodsThis was a randomized study (NCT05348447) of adults scheduled for a minimally invasive thoracic procedure. Each intercostal space near the incision site was injected with lidocaine and bupivacaine with epinephrine (standard-of-care). The cryo-analgesia group also had 5-6 intercostal nerves ablated. The primary outcome was the amount of narcotics (in morphine mg equivalent, MME) taken during the postoperative hospital stay and the first two weeks post-discharge. Secondary outcomes were incentive spirometry (IS) volume and pain scores in the hospital and pain and neuropathy scores at two weeks. ResultsOur final cohort contained 103 patients (52 standard-of-care; 51 cryo-analgesia). There were no differences between the treatment groups in MMEs administered during the hospital stay (44.9 mg standard of care vs. 38.4 mg cryo-analgesia), total MME at two weeks (108.8 vs. 95.2 mg), or pain assessed on postoperative day (POD) 1 (3.8 and 3.3), POD2 (2 and 3.5), or two weeks (2 and 3.5). The decrease in IS in the postoperative period was not significantly different between the two groups. Patients in the cryo-analgesia group had higher neuropathy scores (8 vs. 13, p=0.019) two weeks after surgery. ConclusionsIn this randomized study, cryo-analgesia did not decrease postoperative pain or narcotic requirements. Cryo-analgesia increased neuropathic pain two weeks after surgery.

Shaping Clinical Policy for Salvage Radiotherapy After Radical Prostatectomy in Prostate Cancer: Bridging the Gap Between Clinical Trials and Daily Practice.

Salvage radiotherapy (sRT) can have similar outcomes to adjuvant radiotherapy (aRT) if administered at the earliest evidence of biochemical recurrence. RADICALS-RT was the first trial to support this hypothesis and a policy of observation after radical prostatectomy (RP) with early sRT has become the new standard of care since then. This study assessed the impact of RADICALS-RT in the clinical practice regarding the timing of sRT for prostate cancer initially treated with RP. Data from 297 patients who underwent sRT after radical RP were retrospectively collected. Two groups were created and analyzed on the basis of the date of RADICALS-RT presentation at ESMO. After these results were released in October 2021, our institutional postoperative radiotherapy policy was revisited, and a third group was created and analyzed separately. Median PSA for Groups 1, 2, and 3 were 0.33, 0.27, and 0.2, respectively. Less than one-third of patients in Groups 1 and 2 had a postoperative PSA of 0.2 ng/mL or less at the time of sRT. Group 3 showed statistically significant differences in median PSA at the time of sRT compared with Groups 1 and 2. RADICALS-RT demonstrated a significant impact on clinical practice only after being complemented with real local evidence.

Acquired Hemophilia A: A Narrative Review and Management Approach in the Emicizumab Era

Acquired Hemophilia A (AHA) is a rare bleeding disorder caused by inhibitory autoantibodies to factor VIII (FVIII). The goals of treatment are two-fold, namely immunosuppressive therapy (IST) to eradicate the inhibitor and hemostatic management to control bleeding. Emicizumab, a bispecific antibody that acts as a factor VIIIa (FVIIIa) mimetic, has seen growing use in AHA following its approval for congenital hemophilia A (cHA). This review provides an overview of the epidemiology, pathophysiology, diagnosis, and treatment of AHA. Registry, trial, and case series data are assimilated and summarized with an emphasis on a standardized approach that integrates the use of emicizumab. With recent registry data suggesting the need to focus on immunosuppression-related mortality in AHA, we provide treatment recommendations in an algorithmic format that have become the standard of care at our institution. These recommendations are intended to minimize hemostatic product usage and potential toxicity related to IST, while reducing morbidity and re-hospitalization rates for bleeding. The proposed treatment algorithm, which includes key interventions by phase of therapy, can be readily implemented at centers that have rapid access to plasma FVIII activity using a one-stage assay. A case is presented to illustrate the proposed diagnostic and management considerations.

Evaluation of CellerateRX® Utility in Reducing Groin Complications after Femoral Exposure

OBJECTIVEVascular procedures involving groin incisions for femoral exposure often have complications that delay wound healing. These complications include but are not limited to development of seromas, hematomas, or infection requiring reintervention leading to readmission, increased length of stay, and increased morbidity & mortality, including limb loss. In this prospective study, we evaluate the utility of CellerateRX® surgical powder in preventing postoperative groin complications. We compare outcomes of groin incisions that received standard surgical wound care and those that were additionally packed with CellerateRX® powder. METHODSGroin incisions required for femoral exposure in vascular surgery procedures were considered. The control group included cases between 2020-2021. Exclusion criteria included patients less than 18 years of age, those with a bovine allergy, those with an active groin infection, or those undergoing a repeat femoral exposure. Bilateral groin incisions were counted as two separate constituents in the overall sample. The perioperative protocol in the management of these patients included one-hour preoperative vancomycin (15 mg/kg IV)/ceftriaxone (2 g IV), double skin preparation with 4% chlorhexidine, hair removal with surgical clippers, IobanTM, postoperative doxycycline (100 mg PO/IV BID for 24 hours), and negative pressure wound therapy or a muscle flap in high-risk patients. Patients between 2022-2023 who met the described inclusion criteria were enrolled into the experimental group. The only change to the perioperative protocol of the experimental group was the addition of CellerateRX® powder to the surgical wound before closure. Patients were followed for 6 months. The primary outcome was the number of groin complications that required return to the operating room (e.g., seroma, hematoma, infection). RESULTSThe control group consisted of 137 groins, 17 (13%) of which developed complications—7 (5.2%) seromas, two (1.5%) hematomas, five (3.7%) soft tissue infections, and three (2.2%) skin necrosis cases. The treatment group consisted of 20 groins, 3 (15%) of which developed complications—two seromas and one soft tissue infection. A two-tailed Fisher’s exact test demonstrated no statistically significant association between the presence of complications and the treatment group (p=.49, α=.05). CONCLUSIONSBased on the results of this study, we cannot conclude that packing wounds with CellerateRX® powder alters the risk of developing postoperative groin complications compared to standard wound care. Although the number of hematomas and skin necrosis were not observed in the treatment group, the observed differences may be due to the small sample size.