Design of VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1): A double-blind, randomized placebo-controlled trial of COVID-19 convalescent plasma in hospitalized patients with early respiratory compromise.

Background: Effective therapeutics for severe acute respiratory syndrome CoronaVirus-2 (SARS-CoV-2) infection are evolving. Under Emergency Use Authorization, COVID-19 convalescent plasma (CCP) was widely used in individuals hospitalized for COVID-19, but few randomized controlled trials supported its efficacy to limit respiratory failure or death. Methods: VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1) was a double-blind, multi-site, placebo-controlled, randomized clinical trial evaluating the efficacy and safety of CCP with conventional therapy in hospitalized Veterans with SARS-CoV-2 infection and early respiratory compromise (requirement for oxygen). Participants (planned sample size 702) were randomized 1:1 to receive CCP with high titer neutralizing activity or 0.9% saline, stratified by site and age (≥65 versus <65 years old). Participants were followed daily during initial hospitalization and at Days 15, 22 and 28. Outcomes: The composite primary outcome was acute hypoxemic respiratory failure or all-cause death by Day 28. Secondary outcomes by day 28 included time-to-recovery, clinical severity, mortality, rehospitalization for COVID-19, and adverse events. Serial respiratory and blood samples were collected for safety, virologic and immunologic analyses and future studies. Key variables in predicting the success of CURES-1 were: (1) enrollment early in the course of severe infection; (2) use of plasma with high neutralizing activity; (3) reliance on unambiguous, clinically meaningful outcomes. CURES-1 was terminated for futility due to perceived inability to enroll in the lull between the Alpha and Delta waves of the SARS CoV-2 epidemic. Conclusions: VA CURES-1 was a large multi-site trial designed to provide conclusive information about the efficacy of CCP in well-characterized patients at risk for progression of COVID-19. It utilized a rigorous study design with relevant initial timing, quality of product and outcomes. Trial registration: ClinicalTrials.gov Identifier: NCT04539275.

Acupuncture in the Treatment of Panitumumab Skin Toxicity: A Case Report.

BACKGROUND: Inflammatory skin rash resulting from treatment with epidermal growth factor receptor inhibitors may cause physical and mental disabling to patients treated for their oncologic condition and may, in some cases, lead to the cessation of biological treatment. CASE REPORT: In this case report, acupuncture treatment was provided to a patient with metastatic colorectal carcinoma who developed skin toxicity from panitumumab including rash, itching, and skin inflammation. Itching, infection, and inflammation symptoms improved significantly following acupuncture, subsequently relapsed following treatment cessation, and improved once again following reintroduction of acupuncture. CONCLUSION: Acupuncture may be effective in alleviating panitumumab-related skin inflammatory symptoms.

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER), a pragmatic trial for conservative chronic low back pain treatment.

BACKGROUND: Chronic low back pain (cLBP) is a common and highly disabling problem world-wide. Although many treatment options exist, it is unclear how to best sequence the multitude of care options to provide the greatest benefit to patients. METHODS: The Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER) trial uses a pragmatic, randomized, stepped design. Enrollment targets 2529 participants from 20 Veterans Affairs (VA) medical centers. Participants with chronic low back pain will first be randomized to one of three options: 1) an internet-based self-management program (Pain EASE); 2) a tailored physical therapy program (Enhanced PT); or 3) continued care with active monitoring (CCAM), a form of usual care. Participants not achieving a 30% or 2-point reduction on the study's primary outcome (Brief Pain Inventory Pain Interference (BPI-PI) subscale), 3 months after beginning treatment may undergo re-randomization in a second step to cognitive behavioral therapy for chronic pain, spinal manipulation therapy, or yoga. Secondary outcomes include pain intensity, back pain-related disability, depression, and others. Participants will be assessed every three months until 12 months after initiating their final trial therapy. Companion economic and implementation analyses are also planned. RESULTS: The SCEPTER trial is currently recruiting and enrolling participants. CONCLUSIONS: Trial results will inform treatment decisions for the stepped management of chronic low back pain - a common and disabling condition. Additional analyses will help tailor treatment selection to individual patient characteristics, promote efficient resource use, and identify implementation barriers of interventions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT04142177.

Treatment of acute exacerbations of chronic obstructive pulmonary disease with acupuncture during hospitalization: a three-arm double-blinded randomized sham-controlled trial.

BACKGROUND: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a healthcare burden. Acupuncture improves dyspnea in patients with chronic obstructive pulmonary disease (COPD) but, to the best of our knowledge, has not been tested in AECOPD. Here, we evaluated the efficacy and safety of true acupuncture added to standard of care (SOC), as compared with both sham procedure plus SOC and SOC only, for the treatment of AECOPD among inpatients. METHODS: This double-blinded randomized sham-controlled trial was set in a tertiary hospital in Israel. Patients with a clinical diagnosis of AECOPD were assigned to true acupuncture with SOC, sham procedure with SOC or SOC only. The primary outcome was dyspnea improvement as measured daily by the validated modified Borg (mBorg) scale. Secondary outcomes included improvement of other patient-reported outcomes and physiologic features, as well as duration of hospitalization and treatment failure. Acupuncture-related side effects were evaluated by the validated Acup-AE questionnaire. RESULTS: Seventy-two patients were randomized: 26 to acupuncture treatment, 24 to sham and 22 to SOC only arms. Baseline characteristics were similar in the three groups. A statistically significant difference in dyspnea intensity was found from the first day of evaluation after treatment (p = 0.014) until day 3 after treatment. Similar results were found for sputum production, but no statistical significance was found when comparing physiologic features between the three arms. Acupuncture was not associated with adverse events. CONCLUSION: Acupuncture seems to be efficacious in the treatment of AECOPD among inpatients hospitalized in internal medicine departments. TRIAL REGISTRATION NUMBER: NCT03398213 (ClinicalTrials.gov).

Safety and efficacy of the BNT162b mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia.

Patients with chronic lymphocytic leukemia (CLL) have a suboptimal humoral response to vaccination. Recently, BNT162b2, an mRNA COVID-19 vaccine with a high efficacy of 95% in immunocompetent individuals, was introduced. We investigated the safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with CLL from nine medical centers in Israel, Overall 400 patients were included, of whom 373 were found to be eligible for the analysis of antibody response. The vaccine appeared to be safe and only grade 1-2 adverse events were seen in 50% of the patients. Following the second dose, an antibody response was detected in 43% of the cohort. Among these CLL patients, 61% of the treatment-na ve patients responded to the vaccine, while responses developed in only 18% of those with ongoing disease, 37% of those previously treated with a BTK inhibitor and 5% of those recently given an anti-CD20 antibody. Among patients treated with BCL2 as monotherapy or in combination with anti-CD20, 62% and 14%, respectively, developed an immune response. There was a high concordance between neutralizing antibodies and positive serological response to spike protein. Based on our findings we developed a simple seven-factor score including timing of any treatment with anti-CD20, age, treatment status, and IgG, IgA, IgM and hemoglobin levels. The sum of all the above parameters can serve as a possible estimate to predict whether a given CLL patient will develop sufficient antibodies. In conclusion, the BNT162b2 mRNA COVID-19 vaccine was found to be safe in patients with CLL, but its efficacy is limited, particularly in treated patients.

Acupuncture Treatment of Delirium in Older Adults Hospitalized in Internal Medicine Departments: An Open-Label Pragmatic Randomized-Controlled Trial.

BACKGROUND: Acupuncture seems to improve cognitive function in experimental models and to reduce agitation in dementia. The addition of acupuncture to standard-of-care (SOC) may improve clinical outcomes related to delirium in hospitalized older adults. METHODS: This pragmatic open-label randomized-controlled trial evaluated 81 older adults hospitalized in an internal medicine ward and diagnosed with delirium. Fifty were randomized to daily acupuncture combined with SOC and 31 to SOC only for up to 1 week. Delirium was diagnosed using Confusion Assessment Method (CAM) tool, and its severity was assessed by the long CAM-Severity (CAM-S) tool. The primary study outcome was delirium resolution evaluated as time-to-first delirium remission (over 7 days) and the number of days spent delirium-free. RESULTS: Time-to-first delirium remission was shorter in the acupuncture arm as compared to the SOC only arm (p < 0.001). A multivariate Cox regression analysis showed a shorter time-to-first remission of delirium in the acupuncture arm as compared with SOC arm [Hazard Ratio 0.267 (95% CI 0.098-0.726, p = 0.010)]. In the 7 days of evaluation, a significantly higher number of delirium-free days was found in the acupuncture arm compared to the SOC arm (p < 0.001), and CAM-S sum from day 2 to day 7 of evaluation was significantly lower in the acupuncture group compared to the control group (p = 0.002). No adverse safety event was found in the acupuncture group. CONCLUSION: Acupuncture seems to be safe and effective in the treatment of delirium in older patients hospitalized in internal medicine departments.

Richter Transformation in Chronic Lymphocytic Leukemia: Update in the Era of Novel Agents.

Richter transformation (RT) is a poorly understood complication of chronic lymphocytic leukemia (CLL) with a dismal prognosis. It is associated with a switch in histopathology and biology, generally with a transformation of the original CLL clone to diffuse large B-cell lymphoma (DLBCL) or less frequently to Hodgkin's variant of Richter transformation (HVRT). It occurs in 2-10% of CLL patients, with an incidence rate of 0.5-1% per year, and may develop in treatment-naïve patients, although it is more common following therapy. In recent years, there has been a deeper understanding of the molecular pathogenesis of RT that involves the inactivation of the TP53 tumor suppressor gene in 50-60% of cases and the activation of aberrations of NOTCH1 and MYC pathways in about 30% of cases. Compared to the preceding CLL, 80% of cases with DLBCL-RT and 30% of HVRT harbor the same IGHV-D-J rearrangements, indicating a clonal evolution of the disease, while the remaining cases represent de novo lymphomas that are clonally unrelated. Despite advances in understanding the molecular variations and the pathogenesis of the disease, there is still no significant improvement in patient outcomes. However, if no clinical trials were designed for patients with RT in the past, now there many studies for these patients that incorporate new drugs and novel combinations that are being explored. In this review, we summarize the new information accumulated on RT with special emphasis on results involving the novel therapy tested for this entity, which represents an unmet clinical need.

A statistical quality assessment method for longitudinal observations in electronic health record data with an application to the VA million veteran program.

BACKGROUND: To describe an automated method for assessment of the plausibility of continuous variables collected in the electronic health record (EHR) data for real world evidence research use. METHODS: The most widely used approach in quality assessment (QA) for continuous variables is to detect the implausible numbers using prespecified thresholds. In augmentation to the thresholding method, we developed a score-based method that leverages the longitudinal characteristics of EHR data for detection of the observations inconsistent with the history of a patient. The method was applied to the height and weight data in the EHR from the Million Veteran Program Data from the Veteran's Healthcare Administration (VHA). A validation study was also conducted. RESULTS: The receiver operating characteristic (ROC) metrics of the developed method outperforms the widely used thresholding method. It is also demonstrated that different quality assessment methods have a non-ignorable impact on the body mass index (BMI) classification calculated from height and weight data in the VHA's database. CONCLUSIONS: The score-based method enables automated and scaled detection of the problematic data points in health care big data while allowing the investigators to select the high-quality data based on their need. Leveraging the longitudinal characteristics in EHR will significantly improve the QA performance.

COVID-19 among patients with hematological malignancies: a national Israeli retrospective analysis with special emphasis on treatment and outcome.

This national Israeli multicenter retrospective study aimed to characterize the clinical course of COVID-19 infection among patients with hematological malignancies, with special emphasis on treatment efficacy and outcome. Clinical and laboratory data from haemato-oncological patients diagnosed with COVID-19 from 16 medical centers were centrally reported. Multivariate regression analyses were used to determine variables associated with severe disease, hospitalization, and mortality. In total, 313 patients were included: 103 (35.7%) developed severe/critical respiratory infection, 178 (61.4%) were hospitalized, and 60 (20.0%) died. Age > 70 years was associated with severe/critical disease (p = 0.036) and mortality (p = 0.023), hypertension with severe/critical disease (p = 0.046) and hospitalization (p = 0.001), active haemato-oncological treatment with hospitalization (p = 0.009), and remdesivir treatment was associated with decreased mortality (p = 0.021). Convalescent plasma, enoxaparin, and corticosteroids resulted in no clinical benefit. In conclusion, COVID-19 infection seems particularly severe in patients with hematological malignancies, and of all examined therapies, remdesivir appears to be the most effective.

The impact of COVID-19 on patients with hematological malignancies: the mixed-method analysis of an Israeli national survey.

BACKGROUND: The COVID-19 pandemic required reevaluation of the therapeutic approach and added emotional stress for patients with hematological malignancies at high risk of contracting the virus. We aimed to evaluate how it affected such patients during the second lockdown in Israel. METHODS: This national survey included Hebrew-speaking patients with hematological malignancy. This included three tools with 28 items of sociodemographic and medical baseline characteristics, management of hematological disease, and evaluation of emotional coping during COVID-19 pandemic; the Hebrew version of the Patient Health Questionnaire 9; and 3 qualitative open-ended questions. Data was analyzed by mixed methods which combined both quantitative and qualitative thematic analyses. RESULTS: Four hundred eight patients responded to the survey. The management of their hematological disease included a decrease in the number of visits to the hematology clinic (37.0%), delay of some treatment schedules (9.1%), and prescription of replacement therapies permitting less visits to the clinic (2.2%). The frequency and intensity of "feeling afraid" regarding COVID-19 infection was increased (mean ± SD: 4 ± 1 to 5 ± 2 in a 1-7 Likert scale), and a high rate of depression was recorded, which appeared to be more evident in patients with chronic myeloid leukemia (CML) (p < 0.001). CONCLUSION: The management of hematological malignancies during pandemics should always take into consideration patients' fears, as well as the development of depression related to isolation and loneliness, in addition to the high risk of severe disease. Patients with CML had a high rate of depression which obviously needs to be managed very carefully during and after the COVID-19 pandemic.

Interruptions to Attending Physician Rounds and Their Effect on Resident Education.

BACKGROUND: Daily attending rounds (AR) are a cornerstone of teaching and patient care in academic health centers. Interruptions in health care are common and can cause increased risk of errors, incomplete work, and decreased decision-making accuracy. Interruptions to AR may diminish a trainee's capacity to learn and retain information. OBJECTIVE: We characterized and quantified interruptions that occur during AR. METHODS: We used a mixed-methods design combining a prospective observational study with a qualitative study. AR were observed January to March 2020 to characterize interruptions, followed by semi-structured interviews with the observed physicians to elucidate the effect of interruptions on workflow and the educational value of rounds. RESULTS: There were 378 observed interruptions over the course of 30 AR sessions, averaging 12.6 (range 1-22, median 13) interruptions per rounding session. Bedside nursing staff was the most common source of interruptions (25%) and consultant recommendations was the most common topic of interruption (21%). Most interruptions occurred during patient presentations (76%), and the most common method of interaction was text message (24%). Most team members described negative effects of interruptions, including loss of focus and missing critical clinical information; some also reported that certain interruptions had positive effects on education and clinical care. Interns were more likely to report negative emotional reactions to interruptions. CONCLUSIONS: AR are frequently interrupted for non-urgent topics by a variety of methods and sources. Negative effects included loss of focus, missed information, and increased stress. Proactive communication, particularly between physicians and nurses, was suggested to reduce interruptions.

Treatment Preferences for Chronic Low Back Pain: Views of Veterans and Their Providers.

PURPOSE: This study was conducted to characterize chronic low back pain (cLBP) and to identify treatment histories and preferences for cLBP management among Veterans and primary care providers within the Veterans Affairs (VA) healthcare system. PARTICIPANTS AND METHODS: Veterans with cLBP from five geographically diverse VA medical centers were identified using International Classification of Diseases (ICD) 9 and 10 codes from VA administrative data as were primary care providers at these same sites. From these data, Veterans (200/per site) and providers (160/per site) were selected and mailed surveys. Open-ended interview data were collected from a subset of Veterans and providers. RESULTS: In total, 235 Veterans and 67 providers returned completed surveys. More than 80% of the Veteran respondents had daily back pain for more than 1 year. Most Veterans had tried several treatments for their pain with medications and physical therapy being the most commonly used. Veterans and providers had similar attitudes towards many cLBP treatments with the exception of psychological therapies that were more favored by providers. Open-ended interview data showed that Veterans and providers emphasized the need for multi-component approaches to treatment. CONCLUSION: Among Veterans, cLBP is typically of sustained duration, is relatively severe, and also interferes significantly with normal functioning. Veterans are experienced with respect to treatments and had similar attitudes towards many cLBP treatments as their providers, especially tailored approaches.

Improving the international prognostic index score using peripheral blood counts: Results of a large multicenter study involving 520 patients with diffuse large B cell lymphoma.

The main purpose of this study was to assess whether it is possible to improve the prognostic impact of international prognostic index (IPI) score by combining it with peripheral blood counts. Thus, we evaluated the prognostic power of lymphocyte, neutrophil, and monocyte counts in 520 patients with diffuse large B cell lymphoma treated with R-CHOP, confirming that these parameters have a strong impact on overall survival (OS). Using revised IPI (R-IPI), 44% of patients were categorized as poor-risk and showed an OS at 5 years of 46%. As OS at 5 years of the 520 patients is 67%, it is clearly evident that R-IPI tends to overestimate the proportion of patients with poor prognosis. Accordingly, in an attempt to improve the discriminating power of R-IPI, we evaluated and compared three different scores by combining the neutrophil lymphocyte ratio (NLR) and absolute monocyte count (AMC) with the following values: (a) IPI score 3-5, (b) age > 60 years and performance status, (c) age ≥ 65 years and LDH > ULN. The three indexes studied, had a similar 5 years OS for the high-risk group (46%-52%), but the proportion of patients classified as poor-risk were 37%, 20%, and 32%, respectively, which are lower than 44% identified with R-IPI. Thus, while R-IPI overestimates the number of high-risk patients, after applying our models, it is possible to recognize patients who are truly at high-risk. Of the three scores, the most accurate appears to be that based on NLR, AMC, LDH > ULN and age ≥ 65 years, which identifies 32% of high-risk patients, correlating well with what is seen in clinical practice.

The effectiveness of foot reflexology in reducing anxiety and duration of labor in primiparas: An open-label randomized controlled trial.

BACKGROUND AND PURPOSE: Reflexology alleviates anxiety and may shorten the duration of labor. We evaluated the effect of reflexology on anxiety level and duration of labor in primiparas with moderate-to-severe anxiety. MATERIALS AND METHODS: In this open-label randomized-controlled trial, primiparas with moderate-to-severe anxiety were randomized into one of two groups: addition of reflexology to usual care, or usual care only. The primary outcome was a change in the level of anxiety during reflexology treatment. RESULTS: Ninety-nine women were assigned to reflexology treatment while ninety received usual care only. A larger alleviation of anxiety was observed immediately after reflexology treatment as compared to the control group during the 30 min following group assignment. Reflexology did not affect the length of delivery. CONCLUSION: Foot reflexology had a positive short-term anxiolytic effect during labor in primiparas with moderate-to-severe anxiety but did not affect the duration of labor.

Increasing the Frequency of Night Float Teaching with a Daily Management System: Where Medical Education Meets Quality Improvement.

Daytime resident rotations have a well-established system for incorporating didactic teaching into clinical rotations. However, how to create and sustain a parallel system of didactics for night rotations is less established. We aimed to use Lean methodology to increase the frequency of didactic teaching at night and improve house staff perception of the educational value of night float. Our educational intervention was comprised of the implementation of a daily management system (DMS) with a visual dashboard to track whether evening report was held and a repository of prepared lectures. With this intervention, the rate of evening report tripled from 18 to 55%, demonstrating that a daily management system can be successfully used to improve performance of an educational outcome by increasing attending and resident engagement on night float.

Primary peg-filgrastim prophylaxis versus filgrastim given "on demand" for neutropenia during therapy with cladribine for hairy cell leukemia.

BACKGROUND: Major advances in the treatment of patients with hairy cell leukemia (HCL) have been made following the introduction of purine analogues. The major significant short-term toxicity of cladribine therapy are neutropenia and neutropenic fever (NF) which may be life-threatening. AIM: In this retrospective study, we compared the incidence and duration of neutropenia and hospitalization in patients with HCL treated with cladribine followed by peg-filgrastim as primary prophylaxis versus daily filgrastim given "on demand" according to absolute neutrophil count (ANC). METHODS: Medical records of patients with HCL diagnosed and followed in 12 medical centers in Israel during 1985-2015 were examined for details of disease at diagnosis. The efficacy of peg-filgrastim and filgrastim was assessed by evaluating the incidence of neutropenia (ANC < 1.0 × 10 [9]/L), number and length of hospitalizations, and number of days from the last day of therapy to recovery of ANC to >1.0 × 10 [9]/L. RESULTS: The study population included 202 patients with HCL, 159 of whom (80.7%) were treated with cladribine; 78 patients (49%) required hospitalization for the administration of broad-spectrum antibiotics due to NF. Twenty-eight (19%) patients were treated with peg-filgrastim as primary prophylaxis, while 74 (64%) received filgrastim "on demand" due to neutropenia. Median length of hospitalization, and nadir duration were 8 and 18 days respectively (p = 0.71, p = 0.44). CONCLUSIONS: Infectious complications post-cladribine treatment remain high. No difference was found in terms of incidence of NF, number of febrile days, and nadir duration in patients receiving primary peg-filgrastim prophylaxis compared to filgrastim given on demand. Both approaches are justifiable, and the choice remains at the physician's discretion.

The study protocol for a randomized, controlled trial of acupuncture versus a sham procedure versus standard care alone for the treatment of delirium in acutely hospitalized older adults with a medical illness.

BACKGROUND: Many hospitalized older adults experience delirium, but treatment options are limited. Acupuncture has been shown to improve cognitive function and reduce agitation in dementia. We hypothesize that acupuncture, when compared with a sham intervention, will reduce the duration and severity of delirium, normalize delirium biomarkers, and improve clinical outcomes related to delirium in acutely hospitalized older adults with a medical illness. METHODS: This three-arm, prospective, randomized, clinical trial will evaluate adults aged over 65 years who are acutely hospitalized to an internal-medicine ward and diagnosed with delirium or subsyndromal delirium. The 288 patients (96 in each of three groups) will be randomly allocated to receive either daily true acupuncture with usual care, a daily sham procedure with usual care, or usual care only in a 1:1:1 distribution for up to one week or until the patient is delirium-free for over 48 h. Other delirium and clinical interventions will remain unchanged. Delirium will be diagnosed using DSM-5 criteria and its severity will be assessed using the long Confusion Assessment Method Severity (CAM-S) tool. OUTCOMES: The primary study outcome will be the daily CAM-S score over 7 days between the three groups. Secondary outcomes will include time to first resolution of the delirium (over 7 days), the proportion of days spent delirium-free, daily antipsychotic use, daily pain scores, sleep quality, morning serum cortisol and T3 levels, and midnight urinary cortisol/creatinine ratio, all determined twice a week, and delirium-related complications. Hospital mortality, duration of hospital stay and functional status at discharge will also be compared between the three groups. Adverse events potentially related to acupuncture will be evaluated daily. The cost-effectiveness of acupuncture will be estimated. CONCLUSION: This novel randomized study will evaluate both the specific and the non-specific effects of acupuncture on delirium, and related outcomes, and its safety. Potential mechanism(s) of action for acupuncture in reducing delirium will be explored and healthcare-related costs estimated. Positive study results may prove pivotal in facilitating a multimodal, non-pharmacologic, integrative approach to delirium treatment among older, medical inpatients.

The prognostic role of end of treatment FDG-PET-CT in patients with diffuse large B cell lymphoma can be improved by considering it with absolute monocyte count at diagnosis.

It is well established that some patients with diffuse large B-cell lymphoma (DLBCL) and the negative end of treatment PET-CT (EOT-PET-CT) will relapse, while a proportion with positive uptake can still obtain long-term EFS. We reviewed data of 200 consecutive, previously untreated patients with DLBCL recorded in Italy and Israel between 2007 and 2015. We found that patients with negative EOT-PET-CT with AMC > 630/mmc have a 3-years EFS of 72%, compared to those with AMC ≤ 630/mmc that have an EFS of 84%. Furthermore, considering patients with positive EOT-PET-CT, those with AMC > 630/mmc have a 3-years EFS of 8%, while those with AMC ≤ 630/mmc have an EFS of 38%. Thus, it appears that combining the gold standard for response evaluation EOT-PET-CT with a simple and inexpensive parameter like AMC at diagnosis, further improves prognostication in DLBCL. Applying this simple method can be useful for all doctors working in lymphoma clinical practice.

Postoperative analgesia by adding acupuncture to conventional therapy, a non-randomized controlled trial.

Background Postoperative pain is common in patients hospitalized in surgical departments, yet it is currently not sufficiently controlled by analgesics. Acupuncture, a complementary medical practice, has been evaluated for its benefits in postoperative pain with heterogeneous results. We tested the feasibility of a controlled study comparing the postoperative analgesic effect of acupuncture together with standard-of-care to standard-of-care only. Methods In this pilot non-randomized controlled study conducted at a tertiary medical center in Israel, patients received either acupuncture with standard-of-care pain treatment (acupuncture group) or standard-of-care treatment only (control group) following surgery. Visual Analogue Scale (VAS) ratings for pain level at rest and in motion were evaluated both at recruitment and two hours after treatment. Acupuncture-related side effects were reported as well. Results We recruited 425 patients; 336 were assigned to the acupuncture group and 89 to the control group. The acupuncture group exhibited a decrease of at least 40% in average level of pain both at rest (1.8±2.4, p<0.0001) and in motion (2.1±2.8, p<0.0001) following acupuncture, whereas the control group exhibited no significant decrease (p=0.92 at rest, p=0.98 in motion). Acupuncture's analgesic effect was even more prominent in reducing moderate to severe pain at baseline (VAS ≥4), with a decrease of 49% and 45% of pain level at rest and in motion respectively (p<0.001), compared with no significant amelioration in the control group (p=0.20 at rest, p=0.12 in motion). No major side effects were reported. Conclusion Integrating acupuncture with standard care may improve pain control in the postoperative setting.