National Clinical Research Articles

Assessing patients’ experience of care in four referral hospitals: a cross-sectional survey of outpatients in two South African rural provinces

BackgroundPatient experience of care surveys are an important component of performance improvement and clinical effectiveness because they serve as a good proxy for patient’s satisfaction and the quality of care. The purpose of this study was to assess patients’ experience of care in four referral hospitals in two of South Africa’s rural provinces.MethodsA cross-sectional study was conducted in four public hospitals in Eastern Cape (Nelson Mandela Academic (NMAH) and St. Elizabeth (SEH)) and Mpumalanga provinces (Rob Ferreira (RFH) and Themba) for two weeks in July 2022. Systematic random sampling was used to select 662 outpatients. A validated patient experience of care questionnaire measuring demographics, access to care, availability of medicines, cleanliness, staff attitudes and waiting times was used. The level of statistical significance was p-value ≤ 0.05.ResultsFemales accounted for 71.6% (474/662) of participants; the median age was 47 years and 20.2% (133/657) required assistance with a disability. Only 19.0% (31/659) of patients had been turned away from hospital previously; one hospital was reported to not be clean (68.5%, 111/162); more than two-thirds of Mpumalanga province participants (223/329, 67.8%) reported absence of drinking water (p-value < 0.0001); 68.5% (111/162) of Themba participants did not think that the hospital was clean compared to NMAH’s 82.2% (134/163) who thought it was clean (p-value < 0.0001). At least 70% of participants in each of the hospitals found the health professionals to be respectful towards patients (p-value < 0.0001). In all hospitals, at least half of the participants did not know the processes to be followed when lodging a complaint (p-value = 0.002). None of the four hospitals met all the national targets. And only two out of 28 potential domains exceeded 80% or the cut-off score for satisfaction.ConclusionsWhilst hospitals have been implementing various quality measures to improve patient’s experience of care, there are a few concerns such as non-availability of drinking water, lack of knowledge of complaints processes and waiting times that were mostly reported to be unacceptable. Efforts should be made to address the highlighted areas that affect patient experiences to continue improving patient care.Trial registrationThe study forms part of a clinical trial which was registered on 19 May 2022 in the South African National Clinical Trial Registry with ref: DOH-27-052022-6854. The URL of trial registry record is: https://sanctr.samrc.ac.za/.

Effects of the COVID-19 pandemic on surgical treatment for thoracic malignant tumor cases in Japan: a national clinical database analysis.

Surgical care has been significantly affected by the COVID-19 pandemic. This study was conducted to evaluate the effects of the pandemic on lung cancer and mediastinal tumor surgery. Changes in the number of surgical procedures for lung cancer and mediastinal tumors were analyzed using the National Clinical Database of Japan. Patient characteristics, including disease stage and histological type, from 2019 to 2022 were evaluated using annual datasets. Comparisons with 2019 showed that the number of patients who underwent surgery for primary lung cancer or a mediastinal tumor decreased in 2020 and then remained stable. There were no clinically significant changes in the trend over the four-year period regarding the number of patients for each clinical and pathological stage of lung cancer. Regarding mediastinal tumors, there was no significant difference in tumor size between years. There was a slight change in the selection of surgical indication during the second quarter of 2020, although its impact on annual trends in the stage distribution for lung cancer and primary disease for mediastinal tumors was minimal. Analyses of lung cancer and mediastinal tumor surgery cases in Japan during the COVID-19 pandemic showed no significant disease profile changes related to treatment delay.

Safety, effectiveness and immunogenicity of heterologous mRNA-1273 boost after prime with Ad26.COV2.S among healthcare workers in South Africa: The single-arm, open-label, phase 3 SHERPA study.

Limited studies have been conducted on the safety and effectiveness of heterologous COVID-19 vaccine boosting in lower income settings, especially those with high-HIV prevalence., The Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S (SHERPA) trial evaluated a mRNA-1273 boost after Ad26.COV2.S priming in South Africa. SHERPA was a single-arm, open-label, phase 3 study nested in the Sisonke implementation trial of 500000 healthcare workers (HCWs). Sisonke participants were offered mRNA-1273 boosters between May and November 2022, when Omicron sub-lineages were circulating. Adverse events (AE) were self-reported, and co-primary endpoints (SARS-CoV-2 infections and COVID-19 hospitalizations or deaths) were collected through national databases. We used Cox regression models with booster status as a time-varying covariate to determine the relative vaccine effectiveness (rVE) of the mRNA-1273 booster among SHERPA versus unboosted Sisonke participants. Of 11248 SHERPA participants in the rVE analysis cohort (79.3% female, median age 41), 45.4% had received one and 54.6% two Ad26.COV2.S doses. Self-reported comorbidities included HIV (18.7%), hypertension (12.9%) and diabetes (4.6%). In multivariable analysis including 413161 unboosted Sisonke participants, rVE of the booster was 59% (95%CI 29-76%) against SARS-CoV-2 infection: 77% (95%CI 9-94%) in the one-Ad26.COV2.S dose group and 52% (95%CI 13-73%) in the two-dose group. Severe COVID-19 was identified in 148 unboosted Sisonke participants, and only one SHERPA participant with severe HIV-related immunosuppression. Of 11798 participants in the safety analysis, 228 (1.9%) participants reported 575 reactogenicity events within 7 days of the booster (most commonly injection site pain, malaise, myalgia, swelling, induration and fever). More reactogenicity events were reported among those with prior SARS-CoV-2 infections (adjusted odds ratio [aOR] 2.03, 95%CI 1.59-2.59) and less among people living with HIV (PLWH) (aOR 0.49, 95%CI 0.34-0.69). There were 115 unsolicited adverse events (AEs) within 28 days of vaccination. No related serious AEs were reported. In an immunogenicity sub-study, mRNA-1273 increased binding and neutralizing antibody titres and spike-specific T-cell responses 4 weeks after boosting regardless of the number of prior Ad26.COV2.S doses, or HIV status, and generated Omicron spike-specific cross-reactive responses. mRNA-1273 boosters after one or two Ad26.COV2.S doses were well-tolerated, safe and effective against Omicron SARS-CoV-2 infections among HCWs and PLWH. Trial registration: The SHERPA study is registered in the Pan African Clinical Trials Registry (PACTR): PACTR202310615330649 and the South African National Clinical Trial Registry (SANCTR): DOH-27-052022-5778.

Benchmarks of Success in Radiotherapy versus Systemic Therapy National Clinical Trials Network (NCTN) Randomized Controlled Trials Sponsored by the National Cancer Institute (NCI)

Abstract Background The National Clinical Trials Network (NCTN) is the largest government sponsored organization in the United States tasked with funding randomized controlled trials (RCTs) in oncology. It is unknown whether there are differences in study design by treatment modality. We evaluated differences in methodology between trials testing radiotherapy versus systemic therapy. Methods The Clinical Trials Support Unit website was used to identify active RCTs of systemic or radiotherapy across NCTN cooperative groups through December 31, 2023. Studies in disease sites with &amp;gt; 5 radiotherapy trials were included. Each trial’s protocol was reviewed to obtain key design information that were descriptively compared: primary endpoint, hypothesis testing type (superiority vs non-inferiority), non-inferiority margin, hypothesized effect size, power, and significance level. Results A total of 186 RCTs (142 systemic therapy, 44 radiotherapy) were examined. Comparing primary endpoints, 59.1% vs 26.8% of radiotherapy vs systemic therapy trials, respectively, had a primary endpoint of overall survival. Nearly 1/3 of radiotherapy trials (31.2%) were non-inferiority vs 6.3% of systemic therapy trials. Among breast cancer trials, 75% of radiotherapy studies were non-inferiority vs 11.1% systemic. Target effect size, power, and significance level were similar by treatment modality within tumor types and disease settings. Conclusion Among NCTN cooperative group RCTs, there were marked differences in study design between radiotherapy vs systemic therapy trials. A higher benchmark for defining success for radiotherapy interventions was observed with greater emphasis on overall survival as primary endpoint. This may reflect differences in therapeutic mechanism by modality and types of study questions posed.

Status of perioperative venous thromboembolism (VTE) prophylaxis in gastrointestinal surgery based on national clinical database (NCD) data in Japan.

To investigate the current status of perioperative venous thromboembolism (VTE) prophylaxis in gastrointestinal surgery in Japan. We reviewed data on eight gastroenterological procedures from the Japanese National Clinical Database (NCD), accrued between 2018 and 2020. Patient characteristics, prophylactic methods, postoperative bleeding, cardiac arrest, and postoperative mortality rate within 30days were retrieved. Despite recommendations, approximately 30% of patients did not receive VTE prophylaxis, suggesting a lack of awareness. Pharmacological prophylaxis was associated with a higher incidence of VTE than mechanical or no prophylaxis for all procedures. Combined prophylaxis resulted in a lower incidence of VTE than pharmacological prophylaxis alone. Pharmacological prophylaxis was also associated with an increased incidence of bleeding events. The risk of cardiac arrest and death was higher in patients with pulmonary embolism (PE), but there was a trend toward lower mortality in the group that received pharmacological prophylaxis. Pharmacological prophylaxis for VTE was limited in reducing the incidence of VTE, but it may reduce the risk of death. Combining pharmacological and mechanical prophylaxis tended to be more effective for preventing VTE than either method alone. Conversely, pharmacological prophylaxis may increase the risk of bleeding.

Association between the COVID-19 pandemic and short-term outcomes after esophagectomy for esophageal cancer in facilities with and without board-certified esophageal surgeons: a nationwide retrospective cohort study.

The COVID-19 pandemic had a profound impact on cancer screening, diagnosis, and treatment procedures. We speculated that during the COVID-19 pandemic, sufficient medical resources were maintained in board-certified hospitals, resulting in favorable short-term outcomes, whereas hospital functions in non-board-certified hospitals declined, leading to mortality increase. The aim of this study is to investigate the impact of COVID-19 pandemic on short-term outcomes after esophagectomy, based on the scale of the facilities. Data of patients who underwent esophagectomy for esophageal cancer between January 2018 and December 2022 were analyzed using the National Clinical Database (NCD) of Japan. We selected the Authorized Institutes for Board-certified Esophageal Surgeons (AIBCESs) certified by the Japan Esophageal Society (JES) at the hospital level for evaluating the difference in outcomes between institutions. Operative mortality rates and other morbidities were evaluated using the standardized mortality and morbidity ratio (SMR, the ratio of the number of observed patients to the expected number of patients). Within the study period, the annual mean operative mortality rate was higher in non-AIBCESs than in AIBCESs. The SMR showed no significant difference after the COVID-19 pandemic in non-AIBCES for mortality, as well as that in AIBCES. In non-AIBCESs, no worsening of results caused by the COVID-19 pandemic was observed despite the shortage of medical resources. Our findings highlighted the high quality of esophageal surgery in Japan during the COVID-19 pandemic, a critical situation with limited medical resources.

Contraception with levonorgestrel-releasing intrauterine system versus copper intrauterine device: a meta-analysis of randomized controlled trials

Globally, approximately 19.4% of women of reproductive age use intrauterine contraception, encompassing both copper intrauterine devices (Cu-IUDs) and levonorgestrel intrauterine devices (LNG-IUDs). Despite current guidelines endorsing intrauterine contraception as a primary method, there remains debate regarding device selection. Notably, the lack of data regarding reasons for discontinuation has limited previous meta-analyses. This study aims to comprehensively evaluate the potential differences between intrauterine devices using available multinational data, thereby providing a basis for global policy and healthcare services. We systematically searched PubMed, EMBASE, Web of Science, and Cochrane Library for primary studies published from inception to January 13, 2024, with no language or geographic restrictions. The study was registered on PROSPERO (CRD42024496400). We included only randomized controlled trials comparing Cu-IUDs and LNG-IUDs. Data extraction was independently conducted by two reviewers, with unresolved discrepancies referred to a third senior reviewer for consultation. The primary outcome was pregnancy, with secondary outcomes encompassing continuation, reasons for discontinuation, expulsion, satisfaction, and other adverse events. Data were synthesized using a random-effects model. Risk of bias was evaluated with the Cochrane Collaboration's tool, and evidence quality was assessed using the GRADE framework. An analysis of 20 trials showed that compared to Cu-IUDs, LNG-IUDs were associated with lower risks of pregnancy (Risk Ratio 0.22, 95% confidence interval 0.12-0.39), ectopic pregnancy (RR 0.12, 95% CI 0.03-0.47), discontinuation due to increased bleeding (RR 0.49, 95% CI 0.28-0.85), increased bleeding (RR 0.42, 95% CI 0.25-0.7), heavy bleeding (RR 0.41, 95% CI 0.22-0.75), and dysmenorrhea (RR 0.41, 95% CI 0.34-0.48), but they carried a higher risk of discontinuation due to amenorrhea (RR 21.05, 95% CI 8.83-50.00). When comparing LNG (52mg) IUD with copper (380mm2) IUD, The LNG-IUD showed a lower risk of discontinuation due to increased bleeding (RR 0.68, 95% CI 0.55-0.58) and dysmenorrhea (RR 0.42, 95% CI 0.34-0.53), but a higher risk of discontinuation due to bleeding issues (RR 2.83, 95% CI 2.47-3.25) and amenorrhea (RR 5.92, 95% CI 2.81-12.49). There were no significant differences between the two terms of continuation, expulsion, non-medical reasons for discontinuation, satisfaction, and other adverse outcomes. LNG-IUDs and Cu-IUDs are both highly effective contraceptive methods. Compared to Cu-IUDs, LNG-IUDs were associated with a lower risk of pregnancy and adverse reactions. However, LNG-IUDs carry a higher risk of amenorrhea. When recommending contraceptive methods, healthcare providers should fully inform patients of these potential risks and consider patient preferences. The research was funded by Hunan Provincial Natural Foundation of China (2021JJ30040), the National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University (2021KFJJ06), and the National Natural Science Foundation of China (No. 81672225).

Assessing the characteristics of suicidal ideation and self-harm in a national older adult population attending emergency departments across Ireland: cohort study protocol

IntroductionOlder people (people aged 65 years and older) have high rates of death by suicide, and self-harm is a major risk factor for suicide. While rates of self-harm decrease with...

Analysis of surgical volume and short‐term outcomes for upper gastrointestinal cancer post‐COVID‐19: Evidence from a nationwide Japanese database

AbstractAimPrevious studies indicated that short‐term outcomes for gastroenterological surgeries did not worsen during the COVID‐19 pandemic. However, it remains unclear whether surgical volumes and medical resource use have recovered postpandemic. This study examines pre‐ and postpandemic trends in upper gastrointestinal surgeries, including esophagectomy and gastrectomy, and their short‐term outcomes.MethodsData from the Japan's National Clinical Database (NCD) were analyzed for patients who underwent esophagectomy for esophageal cancer and gastrectomy for gastric cancer between January 2018 and December 2023. We evaluated changes in surgical volume, intensive care unit (ICU) use, morbidity, mortality rates, and the standardized morbidity and mortality ratio (SMR)—a comparison of observed versus expected outcomes using an NCD‐established risk calculator. Key metrics included 30d mortality, surgical mortality, and four major morbidities like pneumonia and anastomotic leakage.ResultsEsophagectomy volumes remained stable from 2018 to 2023, while gastrectomy volumes decreased notably over the past 6 y. The proportion of patients over 70 increased significantly in both surgery types. Morbidity and mortality rates showed no significant deterioration postpandemic, as indicated by SMR values.ConclusionsThis study analyzed changes in surgical volume and short‐term outcomes for upper gastrointestinal cancer in the post‐COVID‐19 era using a Japanese nationwide database. It found that surgical treatments for gastrectomy and esophagectomy remained safe even after the pandemic.

Lack of Benefit of Autologous Hematopoietic Cell Transplantation (auto-HCT) in Mantle Cell Lymphoma (MCL) Patients (pts) in First Complete Remission (CR) with Undetectable Minimal Residual Disease (uMRD): Initial Report from the ECOG-ACRIN EA4151 Phase 3 Randomized Trial

Background:MCL is a B-cell non-Hodgkin lymphoma for which auto-HCT is often employed in first CR, based on non-randomized phase 2 trials, and a randomized trial (Dreyling et al, Blood 2005) conducted before the advent of more effective induction and maintenance regimens. The TRIANGLE trial (Dreyling et al, Lancet 2024) suggested that auto-HCT may not add benefit to more effective induction and maintenance regimens containing high-dose cytarabine, rituximab and BTK inhibitors. E4151 explored whether auto-HCT benefits pts achieving deep first remission, as measured by a highly sensitive immunoglobulin high throughput sequencing minimal residual disease (MRD) assay.Methods:EA4151 is a four arm trial conducted through the U.S. National Clinical Trials Network (NCTN) and Blood and Marrow Transplant Clinical Trials Network (BMT-CTN). Pts with MCL between the ages of 18 and 70 and in first remission were eligible. After induction, pts underwent PET/CT, bone marrow biopsy, and the clonoSEQ® MRD assay from peripheral blood. Pts in CR with uMRD at 1 in 10-6 sensitivity (uMRD6) were randomized 1:1 to Arm A (auto-HCT + 3 years of maintenance rituximab [MR]) or Arm B (3 years of MR alone), stratified by MIPI-c score and intensive vs non-intensive induction. Pts with either MRD-positive (MRD+) CR or MRD-indeterminate CR (Arm C and Arm D, respsectively) both received auto-HCT + 3 years of MR. Pts who were MRD+ pre-transplant had MRD repeated at day 100. Primary endpoint was to compare overall survival (OS) in Arms A and B, with secondary endpoints including progression-free survival (PFS). Primary analysis population included all randomized pts. As some pts refused their assigned treatment (N=65 [25.3%] for arm A and N=2 [0.8%] for arm B), a “treated as assigned” analysis was also performed. Stratified logrank test was used to compare survival distributions. P-values are two-sided.Results:From Aug 2017 to July 2024, 650 pts were assigned to a treatment arm with 257, 259, 49, and 85 pts enrolled on Arms A, B, C, and D, respectively. Pts were 79% male and 92% white race. Median age was 60 years (range 27-70). MIPI-c was low/low-intermediate (LI) in 63% and high/ high-intermediate (HI) in 37%. Induction was intensive (defined as high-dose cytarabine-containing) in 73% and non-intensive in 27%. A BTK inhibitor was given during induction in 7.2% of pts, and during maintenance in 0.3% of pts.The third pre-planned interim analysis was based on data as of 7/15/24, with median follow up of 2.7 years. The futility boundary was an OS hazard ratio (HR) of 0.984 for Arm A vs B. The estimated OS HR for Arm A vs B in all randomized (n=516) and pts treated as assigned (n=375) were 1.11 (CI 0.71-1.74, p=0.66) and 1.00 (CI 0.58-1.74, p=0.99), respectively and crossed the futility boundary. The 3 year (yr) OS for Arms A and B were 82.1% and 82.7% in all randomized pts, and 86.2% and 84.8% in pts treated as assigned. The estimated PFS HR for Arm A vs B in all randomized and pts treated as assigned were 1.05 (CI 0.71-1.56, p=0.79) and 0.95 (CI 0.59-1.54, p=0.84), respectively. The 3 yr PFS for Arms A and B were 76.6% and 77.4% in all randomized pts, and 81.5% and 80.4% in pts treated as assigned.For Arm C, 3 yr OS and PFS were 81.9% (CI 69.6-96.4%) and 76.9% (CI 64.4-91.7%), respectively. For Arm D, 3 yr OS and PFS were 85.1% (CI 76.0%-95.4%) and 73.4% (62.7-85.9%), respectively. For the MIPI-c low/LI group, 3 yr OS was 84.6% vs 85.7% for Arm A vs B (p=0.96), while in the MIPI-c high/HI group, 3 yr OS was 77.4% vs 77.6% for Arm A vs B (p=0.71). For the intensive induction group, 3 yr OS was 83.0% vs 86.2% for Arm A vs B (p=0.30), while in the non-intensive induction group, 3 yr OS was 79.5% vs 72.8% for Arm A vs B (p=0.48).Exploratory analysis of MRD+ pts (Arm C) showed that pts who converted to uMRD6 post auto-HCT (n=17) had 3 yr OS of 100% and PFS of 100%, whereas those who remained MRD+ (n=13) post auto-HCT had 3 yr OS of 63.6% and PFS of 48.8%. Causes of death (COD) in Arm A were 4.7% lymphoma, 5.1% COVID-19, and 5.0% other/unknown. COD in Arm B were 3.5% lymphoma, 6.6% COVID-19, and 4.6% other/unknown. In Sept 2024, the DSMC recommended termination of accrual and release of trial findings based on these results.Conclusion:In this interim analysis, in the era of highly effective induction and maintenance regimens, MCL pts in first CR with uMRD6 did not benefit from consolidative auto-HCT. Pts who remain MRD+ after induction may benefit from auto-HCT. Longer follow-up will be important to confirm these findings.

Booster-free anti-retroviral therapy for persons living with HIV and multidrug resistance (B-Free): protocol for a multicentre, multistage, randomised, controlled, non-inferiority trial

IntroductionAnti-retroviral therapy (ART) simplification strategies are needed for treatment-experienced people with HIV (PWH) and multidrug-resistant viruses. These individuals are commonly treated with boosted ART regimens and are thereby at risk...

Integrating Endocrine, Genomic, and Extra-Skeletal Benefits of Vitamin D into National and Regional Clinical Guidelines.

Vitamin D is essential for bone health, immune function, and overall well-being. Numerous ecological, observational, and prospective studies, including randomized controlled clinical trials (RCTs), report an inverse association between higher serum 25-hydroxyvitamin D [25(OH)D; calcifediol] levels in various conditions, including cardiovascular disease, metabolic disorders such as diabetes and obesity, susceptibility to infection-related complications, autoimmune diseases, and all-cause mortality. Vitamin D operates through two distinct systems. The endocrine system comprises the renal tubular cell-derived circulatory calcitriol, which primarily regulates calcium homeostasis and muscular functions. In contrast, intracellularly generated calcitriol in peripheral target cells is responsible for intracrine/paracrine system signaling and calcitriol-vitamin D receptor-mediated genomic effects. Government-appointed committees and health organizations have developed various clinical practice guidelines for vitamin D supplementation and management. However, these guidelines heavily relied on the 2011 Institute of Medicine (IoM) report, which focused solely on the skeletal effects of vitamin D, ignoring other body systems. Thus, they do not represent maintaining good overall health and aspects of disease prevention. Additionally, the IoM report was intended as a public health recommendation for the government and is not a clinical guideline. New country- and regional-specific guidelines must focus on healthy nations through disease prevention and reducing healthcare costs. They should not be restricted to bone effect and must encompass all extra-skeletal benefits. Nevertheless, due to misunderstandings, medical societies and other governments have used faulty IoM report as a foundation for creating vitamin D guidelines. Consequently, they placed disproportionate emphasis on bone health while largely overlooking its benefits for other bodily systems, making current guidelines, including 2024, the Endocrine Society less applicable to the public. As a result, the utility of published guidelines has been significantly reduced for clinical practice and RCTs that designed on bone-centric are generate misleading information and remain suboptimal for public health and disease prevention. This review and its recommendations address the gaps in current vitamin D clinical practice guidelines and propose a framework for developing more effective, country and region-specific recommendations that capture the extra-skeletal benefits of vitamin D to prevent multiple diseases and enhance public health.

Insights into cancer characteristics among SARS-CoV-2 infected hospitalized patients: a comprehensive analysis from the National Clinical Registry for COVID-19.

Cancer outcome is dependent on multiple predetermining factors including cancer, type of cancer and its related factors. This study aims to investigate the association between COVID-19 & cancer/cancer types, focusing on risk of in-hospital mortality within 30days of hospitalization of COVID-19 patients with cancer. We did a registry (National Clinical Registry for COVID-19) based retrospective observational study including 51,544 patients, of whom 976 were patients with cancer, admitted with COVID-19 between August 2020 and August 2023 across 42 hospitals of India. Out of 51,544 patients, 976 (1.8%) had cancer. Hematological malignancies made up 15.06% (147 cases), while solid cancers accounted for 29.5% (288 cases), with genitourinary (18.4%, 80 cases), gastrointestinal (15.2%, 49 cases), and lung cancers (10.1%, 34 cases) being the most common. Solid cancers had the highest in-hospital mortality rate at 25%. Survival analysis showed that cancer-related hazards were highest at admission but decreased to levels comparable with other morbidities within nine to ten days. For each cancer type, the hazard was significantly elevated compared to that of the cancer-free (Other Comorbidities and No Comorbiditiy) groups during the initial period of hospitalization. The use of Remdesivir, steroids, and anticoagulants reduced mortality risk, and prior COVID-19 vaccination was protective against mortality across all cancer types. This study shows that both cancer in general and specific cancer types significantly increase the risk of severe outcomes among SARS-CoV-2-infected patients, especially immediately after hospitalization. The findings highlight the need for close monitoring and personalized interventions for COVID-19 patients with cancer for at least 10days post-hospitalization, with a more specific high-risk period ranging from 7 to 18days depending on the type of cancer.

HPB SO26 - Evaluation of Theatre Database Accuracy in a Tertiary HPB Center According to NCIP Standards in the UK

Abstract Background The goal of creating the NCIP (National Clinical Improvement Programme) theatre data set discovery information system is to allow NHS Improvement to evaluate how theatre data can improve the attribution of surgical activities, as documented in Hospital Episode Statistics (HES) Admitted Patient Care (APC) data, to individual consultants. The success of NCIP is at risk due to the inaccurate attribution of existing activity data to consultants. Method The NCIP theatre database for the Hepato-Pancreato-Biliary (HPB) surgery department was compiled over a 12-month period (from April 2022 to April 2023) and analyzed based on the operating consultant recorded in the operative notes, clinical letters, and the Carfelow system (admitting office records). Results In Nottingham University Hospitals (NUH), 143 major liver and pancreatic resections were performed, including 38 Whipple’s procedures (both classic and Pylorus-preserving Pancreatico-Duodenectomy), 19 Distal Pancreatectomies, and 86 Liver resections. Of these, only 58 patients (40.6%) had correct entries in the NCIP database regarding the operating surgeon. The NCIP data inaccuracies for the operating consultant were 65.8% (25/38) for Whipple’s procedures, 57.9% (11/19) for Distal Pancreatectomies, and 56.97% (49/86) for Liver resections. Conversely, the NCIP data was 100% accurate concerning the assigned consultant on Careflow, which matches the clinical letters from the outpatient clinic. Conclusion The gap between the NCIP database and the admitting office database leads to inaccurate attributions of surgical activity. This hinders learning and improvement efforts essential for achieving program benefits and prevents providers from complying with license conditions and delivering efficient healthcare services. To ensure accurate HES data, admitting officers should request proper communication and accurate consultant codes from consultant secretaries to ensure accurate data across the different hospital systems

Identification of risk factors for postoperative complications after right colectomy and low anterior resection in patients ≥85 years old with colorectal cancer using the National Clinical Database

AbstractAimThe purpose of this study was to evaluate factors associated with surgical outcomes and postoperative complications (Grade ≥3 by Clavien–Dindo classification) of right hemicolectomy (RH) and low anterior resection (LAR) for colorectal cancer in patients ≥85 years old.MethodsWe retrospectively analyzed National Clinical Database (NCD) data on patients aged ≥85 years who underwent RH and LAR for colorectal cancer between 2017 and 2020. All possible preoperative factors were used to explore the risk factors for serious postoperative complication in these very elderly patients with colorectal cancer.ResultsFor RH, the operative mortality rate was 1.1% (98 cases), and the rate of serious postoperative complications was 5.2% (480 cases). Similarly, the mortality rate was 1.1% (27 cases), and the rate of serious complications (Clavien–Dindo Grade ≥3) was 8.7% (206 cases) for LAR. Based on multivariate analysis, independent risk factors for serious postoperative complications were male sex, ADL (partially dependent), hypertension, platelets (&lt;150 000/μL), serum Na (&lt;138 mEq/L), and PT‐INR (&gt;1.1) for RH, and ASA‐PS (Grade ≥3), history of pneumonia, creatinine (&gt;1.2 mg/day), and serum Na (&lt;138 mEq/L) for LAR.ConclusionsThe present results for RH and LAR suggest that surgical treatment for patients aged ≥85 years old is safe and feasible. Surgeons need to pay special attention more to physical status and past medical history than to tumor factors to prevent serious postoperative complications in these older patients with colorectal cancer.

Updated risk prediction model for pancreaticoduodenectomy using data from the National Clinical Database in Japan

AbstractAimRisk prediction models for mortality, severe postoperative complications, and postoperative pancreatic fistula in patients undergoing pancreaticoduodenectomy were established using data from the National Clinical Database more than a decade ago, and the surgical outcomes of pancreaticoduodenectomy have improved over the years. The aim of this study is to update the risk prediction model for pancreaticoduodenectomy using National Clinical Database data.MethodsBetween 2019 and 2021, the data of 35 365 patients who underwent pancreaticoduodenectomy and who were registered in the National Clinical Database were retrospectively analyzed. According to the registration year, the patients were divided into two cohorts: the development cohort (2019–2020; n = 23 654) and the validation cohort (2021; n = 11 711). Logistic regression analyses were performed to create risk models for surgical mortality, severe postoperative complications, and grade C postoperative pancreatic fistula.ResultsOverall, the rates of surgical mortality, severe postoperative complications, and grade C postoperative pancreatic fistula were 1.8%, 2.2%, and 1.3%, respectively. Logistic regression analyses revealed 28, 28, and 14 risk factors for surgical mortality, severe postoperative complications, and grade C postoperative pancreatic fistula, respectively. The area under the receiver operating characteristic curve of the risk model in the development cohort was 0.759 for surgical mortality, 0.712 for severe complications, and 0.699 for postoperative pancreatic fistula, comparable to the validation cohort. The calibration plots were favorable in both cohorts.ConclusionThe updated risk model for pancreaticoduodenectomy will be useful to predict surgical mortality, severe postoperative complications, and grade C postoperative pancreatic fistula.

Treatment for acute alcoholic-alimentary pancreatitis with peritoneal syndrome

A large number of publications on surgical treatment of acute alcohol-induced pancreatitis (AAP) with peritonitis indicates the importance of the problem and the need for a differentiated approach to treatment. The aim of this study is to determine the optimal treatment policy for acute alcohol-associated pancreatitis with peritonitis. The study included 114 male patients diagnosed with acute alcoholic pancreatitis and peritoneal sepsis, with an average age of 48.6 ± 6.4 years. They were admitted to the surgical departments of clinical hospitals between 2013 and 2023. The diagnosis of AAP was confi med based on clinical, laboratory, and instrumental findings. The classification of acute pancreatitis recommended by the National Clinical Guidelines of the Ministry of Health of the Russian Federation (2015 and 2020) has been applied. The Acute Physiology and Chronic Health Evaluation II (APACHE II) scale has been used to assess the severity and prognosis of the disease, while the Sequential Organ Failure Assessment (SOFA) scale has been used to evaluate organ failure. Based on the results, an algorithm for the treatment of acute alcoholic and alimentary pancreatitis with peritoneal syndrome has been proposed, taking into account the type of pancreatic necrosis, the extent of pancreatic damage, and the nature of fl uid accumulation. For patients with edematous pancreatitis, small-focal sterile pancreatic necrosis, and enzymatic peritonitis, percutaneous ultrasound-guided abdominal and omental drainage is recommended. In severe and moderate acute alcoholic-alimentary pancreatitis, with enzymatic peritonitis (more than 8 points on the APACHE II scale), which is manifested during diagnostic and sanitation laparoscopy by the presence of a hemorrhagic effusion and a large number of plaques of steatonecrosis on the parietal peritoneum and the large omentum, we should use an endovisual method of draining the abdominal cavity and the omentum to minimize anesthesiological and surgical aggression and to form and maintain general cavities, as well as to create good access to the pancreatic area. For patients with large-focal, infected subtotal or total pancreatic necrosis and purulent peritonitis, it is advisable to perform laparotomy, abdominalization of the pancreas, necrectomy, omentobursostomy, and drainage of purulent foci in the abdominal cavity and retroperitoneal tissue.

Predictive value of pre-treatment circulating tumor DNA genomic landscape in patients with relapsed/refractory multiple myeloma undergoing anti-BCMA CAR-T therapy: Insights from tumor cells and T cells.

B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T (CAR-T) therapy yield remarkable responses in patients with relapsed/refractory multiple myeloma (R/RMM). Circulating tumor DNA (ctDNA) reportedly exhibits distinct advantages in addressing the challenges posed by tumor heterogeneity in the distribution and genetic variations in R/RMM. Herein, the ctDNA of 108 peripheral blood plasma samples from patients with R/RMM was thoroughly investigated before administration of anti-BCMA CAR-T therapy to establish its predictive potential. Flow cytometry is used primarily to detect subgroups of T cells or CAR-T cells. In this study, several tumor and T cell effector-mediated factors were considered to be related to treatment failure by an integrat analysis, including higher percentages of multiple myeloma (MM) cells in the bone marrow (P=0.013), lower percentages of CAR-T cells in the peripheral blood at peak (P=0.037), and higher percentages of CD8+ T cells (P=0.034). Furthermore, there is a substantial correlation between high ctDNA level (>143ng/mL) and shorter progression-free survival (PFS) (P=0.007). Multivariate Cox regression analysis showed that high levels of ctDNA (>143ng/mL), MM-driven high-risk mutations (including IGLL5 [P=0.004], IRF4 [P=0.024], and CREBBP [P=0.041]), number of multisite mutations, and resistance-related mutation (ERBB4, P=0.040) were independent risk factors for PFS. Finally, a ctDNA-based risk model was built based on the above independent risk factors, which serves as an adjunct non-invasive measure of substantial tumor burden and a prognostic genetic feature that can assist in predicting the response to anti-BCMA CAR-T therapy. Chinese Clinical Trial Registry (ChiCTR2100046474) and National Clinical Trial (NCT04670055, NCT05430945).

2024 Chinese guidelines for the diagnosis and treatment of rheumatoid arthritis

Rheumatoid arthritis(RA) is an autoimmune disease characterized by erosive arthritis, which is an important cause of disability in Chinese population. It is of great significance to formulate and update RA diagnosis and treatment guidelines that meet the standards of international guidelines and clinical practice in China. The update of the Chinese guidelines for the diagnosis and treatment of RA was initiated by National Clinical Research Center for Dermatologic and Immunologic Diseases, jointly with the Chinese Association of Rheumatology and Immunology Physicians, the Rheumatology and Immunology Professional Committee of Chinese Rehabilitation Medical Association, the Rheumatology and Immunology Professional Committee of Chinese Research Hospital Association, and the Rheumatology and Immunology Branch of Beijing Association of Holistic Integrative Medicine. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and the Reporting Items for Practice Guidelines in Healthcare (RIGHT) checklist were followed to update the guidelines. The guidelines provide evidence-based recommendations on 10 clinical issues which were concerned by Chinese rheumatologists. The aim is to improve the level of diagnosis and standard treatment of RA in China, and to improve the quality of life and prognosis of patients.

Sex-specific risk factors and clinical dementia outcomes for white matter hyperintensities in a large South Korean cohort

ObjectiveWhite matter hyperintensities (WMH) on brain MRI images are the most common feature of cerebral small vessel disease (CSVD). Studies have yielded divergent findings on the modifiable risk factors for WMH and WMH’s impact on cognitive decline. Mounting evidence suggests sex differences in WMH burden and subsequent effects on cognition. Thus, we aimed to identify sex-specific modifiable risk factors for WMH. We then explored whether there were sex-specific associations of WMH to longitudinal clinical dementia outcomes.MethodsParticipants aged 49–89 years were recruited at memory clinics and underwent a T2-weighted fluid-attenuated inversion recovery (FLAIR) 3T MRI scan to measure WMH volume. Participants were then recruited for two additional follow-up visits, 1–2 years apart, where clinical dementia rating sum of boxes (CDR-SB) scores were measured. We first explored which known modifiable risk factors for WMH were significant when tested for a sex-interaction effect. We additionally tested which risk factors were significant when stratified by sex. We then tested to see whether WMH is longitudinally associated with clinical dementia that is sex-specific.ResultsThe study utilized data from 713 participants (241 males, 472 females) with a mean age of 72.3 years and 72.8 years for males and females, respectively. 57.3% and 59.5% of participants were diagnosed with mild cognitive impairment (MCI) for males and females, respectively. 40.7% and 39.4% were diagnosed with dementia for males and females, respectively. Of the 713 participants, 181 participants had CDR-SB scores available for three longitudinal time points. Compared to males, females showed stronger association of age to WMH volume. Type 2 Diabetes was associated with greater WMH burden in females but not males. Finally, baseline WMH burden was associated with worse clinical dementia outcomes longitudinally in females but not in males.DiscussionOlder females have an accelerated increase in cerebrovascular burden as they age, and subsequently are more vulnerable to clinical dementia decline due to CSVD. Additionally, females are more susceptible to the cerebrovascular consequences of diabetes. These findings emphasize the importance of considering sex when examining the consequences of CSVD. Future research should explore the underlying mechanisms driving these sex differences and personalized prevention and treatment strategies.Clinical trial registrationThe BICWALZS is registered in the Korean National Clinical Trial Registry (Clinical Research Information Service; identifier, KCT0003391). Registration Date 2018/12/14.