Multicenter Prospective Cohort Study Research Articles

Adverse drug reactions and its associated factors among geriatric hospitalized patients at selected comprehensive specialized hospitals of the Amhara Region, Ethiopia: a multicenter prospective cohort study.

Adverse drug reactions are more prevalent in geriatric patients and are frequently associated with a range of polypharmacy-related issues as well as some physiological aging-related alterations. These affect the pharmacokinetic and pharmacodynamic properties of drugs. This study aimed to assess the magnitude of ADRs and their contributing factors among geriatric patients admitted at Comprehensive Specialized Hospitals of the Amhara Region. A multicenter prospective cohort study was carried out from May 2023 to August 2023 on geriatric patients admitted to four randomly selected comprehensive hospitals in the Amhara region. We used logistic regression to find the factors influencing the occurrence of ADRs. A P value of less than 0.05 was deemed statistically significant. During the study's follow-up period, 373 patients in total were included. An incidence rate of 31.10% (95% CI: 26.38-35.82) was obtained from the identification of 121 ADRs in total. The organ most frequently affected by ADRs was the gastrointestinal tract (28.92%), followed by the cardiovascular system (19.01%), and the drug class most often implicated in ADRs was antibiotics (21.49%), then anticoagulants (12.40%). ADRs were substantially linked to being overweight (P < 0.001), having been hospitalized in the previous six months (P = 0.000), and hyperpolypharmacy (p = 0.047). 93.39% of all ADRs received the interventions. 85.12% of the adverse drug reactions were successfully resolved. This study found that over one-third of older people and individuals admitted to the hospital experienced ADRs. Overweight, hyperpolypharmacy, and patients who had previously been admitted during the preceding six months were significantly linked with the occurrence of ADRs. Improving the drug safety of elderly patients, particularly those who are admitted, should be a greater priority for healthcare professionals.

A prophylactic tyrosine kinase inhibitor strategy based on measurable residual disease pre-transplantation for Ph+ acute lymphoblastic leukemia undergoing allogeneic hematopoietic stem cell transplantation: A prospective multicenter cohort study.

Relapse is the major cause of treatment failure in Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). This study aimed to evaluate the effect of a prophylactic tyrosine kinase inhibitor (TKI) strategy on relapse in this population. Patients were assigned to prophylactic or control groups based on measurable residual disease (MRD) pre-transplantation. The primary endpoint was the cumulative incidence of relapse. A total of 110 patients with Ph+ ALL undergoing allo-HSCT were enrolled in this prospective study. Thirty-eight patients with positive MRD pre-transplantation were included in the prophylactic group, and 72 with negative MRD pre-transplantation were included in the control group. The 4-year cumulative incidence of relapse was 25.3% (95% CI: 12.1%-41.0%) and 20.3% (11.6%-30.7%; HR = 1.272, 95% CI: 0.551-2.940, p = .549), and non-relapse mortality was 10.5% (3.3%-22.7%) and 9.7% (4.2%-17.9%; HR = 1.094, 95% CI: 0.320-3.738, p = .928) in the prophylactic and control groups. The 4-year overall survival was 71.8% (53.2%-84.1%) and 84.1% (72.9%-90.9%; HR = 1.746, 95% CI: 0.741-4.112, p = .196), and leukemia-free survival was 64.1% (45.8%-77.7%) and 70.0% (57.6%-79.4%; HR = 1.212, 95% CI: 0.607-2.421, p = .585) in the prophylactic and control groups. Our results suggest that prophylactic TKI post-HSCT in patients with positive MRD pre-transplantation can produce outcomes comparable to negative MRD pre-transplantation without TKI post-HSCT.

Healthcare costs in relation to kidney function among older people: the SCOPE study.

In this study, a comprehensive analysis of costs of chronic kidney disease (CKD) was performed, to understand factors associated with the economic burden of the disease in a multicentre international framework. The impact on costs of demographics, socio-economics, clinical, and functional variables was tested in 2204 subjects aged 75years or more attending outpatient clinics in Europe using a multicentre 2-year prospective cohort study. By means of collected resources consumption and unit cost data a comprehensive cost database was built and then investigated using multilevel regression modeling. Overall, hospitalization, medications and specialist visits were the main cost items, with a notable variability among countries. Estimated yearly costs were 4478€ ± 9804€, rising up to 6683€ ± 10,953€ for subjects with estimated Glomerular Filtration Rate (eGFR) < 30. Costs increased significantly according to the severity of the disease, gender and age. Clinical and functional covariates were also significantly associated with CKD-related total costs, even after correcting for the inter-country variability. Findings corroborate the importance of multidimensional assessment of participants with CKD, as multimorbidity and functional disability produce a detrimental impact on participant's prognosis and cost of care. Preservation of functional impairment and adequate management of comorbidities may thus help decreasing the overall consumption on health care resources in CKD patients, especially in older people.

Abstract A049: Peritoneal tumor DNA as a prognostic biomarker in locally advanced gastroesophageal cancer: A pilot prospective cohort study

Abstract Background: Gastroesophageal cancers commonly spread to the peritoneum. Peritoneal disease significantly alters patient prognosis and treatment-intent. Currently, peritoneal lavage cytology (PLC) is the method of choice for detecting peritoneal micro-metastasis within the peritoneum. Despite its pervasive use, PLC has a variable sensitivity of 10% - 80% in detecting peritoneal micro-metastasis in gastroesophageal cancers. Peritoneal tumor DNA (ptDNA) is tumor-derived DNA detectable in peritoneal lavage fluid. ptDNA-positivity may indicate peritoneal micro- metastasis and may be more sensitive than PLC in staging the peritoneum and predicting disease- free survival (DFS) and overall survival (OS). We aimed to develop and test a tumor-informed platform for ptDNA detection and validate its sensitivity and specificity against PLC. Methods: For this pilot study, peritoneal lavage fluid were collected at staging laparoscopy from 15 patients with gastroesophageal cancer. Cytology and peritoneal metastases (where clinically detectable) were confirmed by histopathology. A tumor-informed ptDNA testing was performed via whole-genome sequencing of tumor tissue and buffy coat to identify somatic variants for each patients, followed by tracking of up to 96 variants in each patient’s peritoneal fluid. Results: 5 out of 15 patients were either cytology positive or had macroscopic peritoneal disease and ptDNA was detectable in all 5 cases. Additionally, out of the 10 cytology-negative patients without macroscopic peritoneal disease, ptDNA positivity was detected in 6 patients prior to commencing neoadjuvant chemotherapy or surgery. Two of these 6 patients demonstrated radiological evidence of recurrence at 15- and 18-months follow-up respectively. Interestingly, one patient with macroscopic peritoneal disease tested negative for cytology. In this case, peritoneal lavage was carried out to the upper two abdominal quadrants only, and the pelvic deposit of disease was detected after the lavage had been completed. Despite a negative cytology result, ptDNA was detected using the same fluid sample, suggesting a higher sensitivity compared to PLC. Conclusions: This pilot study demonstrates that a tumor-informed ptDNA detection platform is feasible and potentially more sensitive than PLC in gastroesophageal cancer. To further validate the clinical utility of ptDNA we are proceeding to a multi-center prospective cohort study. Citation Format: Zexi Allan, Yuxuan Wang, Jeanne Tie, Niall Tebbutt, Nicholas Clemons, Nickolas Papadopoulos, Kenneth Kinzler, Bert Vogelstein, David SH Liu. Peritoneal tumor DNA as a prognostic biomarker in locally advanced gastroesophageal cancer: A pilot prospective cohort study [abstract]. In: Proceedings of the AACR Special Conference: Liquid Biopsy: From Discovery to Clinical Implementation; 2024 Nov 13-16; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(21_Suppl):Abstract nr A049.

Can Ileostomy Reversal Be Safely Performed by Surgical Residents?

Background and Objectives: The growing number of colorectal cancer patients has highlighted the importance of surgical education in colorectal surgery. Despite the negative impact of the COVID-19 pandemic on surgical training, recent changes in the Polish surgical training program have increased the number of intestinal procedures required to be completed by residents. This study aims to assess the safety of ileostomy reversal procedures performed by surgical residents. Materials and Methods: A multicenter prospective cohort study, the LILEO study, was conducted from October 2022 until December 2023 across 20 Polish surgical departments. The study included 199 patients who underwent ileostomy reversal and were divided into two groups: 139 patients operated by specialist surgeons and 60 patients operated by surgical residents. The primary outcomes measured were postoperative complications, length of hospital stay (LOS), and 30-day reoperation rate. Secondary outcomes included the severity of perioperative complications assessed using the Clavien–Dindo classification and a focused analysis of loop ileostomy reversal outcomes. Results: The median LOS was significantly shorter in the resident group (5.5 days vs. 6 days, p &lt; 0.05). Although the overall complication rate was lower in the resident group (21.7% vs. 33.1% in the specialist surgeon group), this difference was not statistically significant (p = 0.105). The 30-day reoperation rate was 3.3% in the resident group and 8.6% in the specialist surgeon group (p = 0.179). In terms of severity, minor complications (Clavien–Dindo grades 1 and 2) were more common in the specialist group (p &lt; 0.05). The analysis of loop ileostomy reversals revealed no significant differences in postoperative outcomes between the two groups. Conclusions: Ileostomy reversal procedures performed by surgical residents under supervision are safe and feasible, with outcomes comparable to those performed only by specialist surgeons. These findings support ileostomy reversal as a valuable procedure for developing surgical residents’ skills and do not negatively affect postoperative outcomes.

Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT)

IntroductionDifferential target multiplexed spinal cord stimulation (DTM SCS) is a new stimulation paradigm for chronic pain management with the aim of modulating glial cells and neurons in order to rebalance...

Does induction or augmentation of labor increase the risk of postpartum hemorrhage in pregnant women with anemia? A multicenter prospective cohort study in India.

To investigate whether induction/augmentation of labor in pregnant women with anemia increases the risk of postpartum hemorrhage (PPH) and whether this risk varied by indications for labor induction/augmentation and by anemia severity in pregnancy. In a prospective cohort study of 9420 pregnant women from 13 hospitals across India, we measured hemoglobin concentrations at recruitment (≥28 weeks of gestation) and blood loss after childbirth during follow-up and collected clinical information about PPH. Clinical obstetric and childbirth information at both visits were extracted from medical records. Anemia severity in the third trimester was categorized using hemoglobin concentrations (no/mild anemia: hemoglobin ≥10 g/dL; moderate: hemoglobin 7 to 9.9 g/dL; severe: hemoglobin <7 g/dL), while PPH was defined based on blood loss volume (vaginal births: ≥500 mL or cesarean sections: ≥1000 mL) and clinical diagnosis. Indications for labor induction/augmentation were classified as clinically indicated and elective as per guidelines. We performed multivariable modified Poisson regression analyses to investigate the associations of anemia severity and indications for labor induction/augmentation, including their interaction, with PPH, adjusted for potential confounders. PPH was associated with anemia but not with indications for labor induction/augmentation. However, there was a significant interaction between the two factors in relation to PPH (P = 0.003). Among pregnant women with severe anemia, a higher risk of PPH was associated with elective (adjusted risk ratio, 3.44 [95% confidence interval, 1.29-9.18]) but not with clinically indicated (adjusted risk ratio, 1.22 [95% confidence interval, 0.42-3.55]) labor induction/augmentation. No associations were observed among pregnant women with no/mild and moderate anemia. The risk of PPH is higher in women who have moderate-severe anemia in late pregnancy. Induction/augmentation of labor is generally safe for women with anemia, but it can increase the risk of PPH in women with severe anemia if performed electively.

Prognostic Implications of Initial Radiological Findings of Pulmonary Fibrosis in Patients with Acute SARS-CoV-2 Infection: A Prospective Multicentric Study

Pulmonary fibrosis detected during the acute phase of SARS-CoV-2 infection may significantly influence patient prognosis. This study aimed to evaluate the prognostic value of initial high-resolution computed tomography (HRCT) findings of pulmonary fibrosis in hospitalized COVID-19 patients and to examine how these findings relate to disease severity and clinical outcomes, with a particular focus on the development and validation of predictive scoring systems. In this multicentric prospective cohort study from January 2023 to January 2024, 120 adult patients with confirmed SARS-CoV-2 infection requiring hospitalization were enrolled from two Romanian university hospitals. Patients were categorized based on the presence (n = 60) or absence (n = 60) of pulmonary fibrosis signs on admission HRCT scans, identified by reticular opacities, traction bronchiectasis, honeycombing, and architectural distortion. Biochemical analyses, severity scores (SOFA, APACHE II, NEWS 2), and novel compound scores combining clinical and radiological data were assessed. Patients with HRCT evidence of pulmonary fibrosis had significantly higher severity scores and worse clinical outcomes. The HRCT score alone was a strong predictor of severe COVID-19 (area under the ROC curve [AUC] = 0.885), with a best cutoff value of 9.72, yielding 85.7% sensitivity and 79.8% specificity. Compound Score 1, integrating SOFA, APACHE II, and HRCT scores, demonstrated excellent predictive performance with an AUC of 0.947, sensitivity of 92.5%, and specificity of 88.9%. Compound Score 2, combining systemic inflammation markers (SIRI, SII) and NEWS 2, also showed a strong predictive capability (AUC = 0.913), with 89.2% sensitivity and 85.7% specificity at the optimal cutoff. Regression analysis revealed that Compound Score 1 had the highest hazard ratio for severe COVID-19 outcomes (HR = 4.89; 95% CI: 3.40–7.05), indicating its superior prognostic value over individual markers and traditional severity scores. Initial HRCT findings of pulmonary fibrosis are significantly associated with increased disease severity in hospitalized COVID-19 patients. The HRCT score is a valuable prognostic tool, and, when combined with clinical severity scores into Compound Score 1, it enhances the prediction of severe COVID-19 outcomes with high sensitivity and specificity. These compound scores facilitate the early identification of high-risk patients, guiding clinical decision-making and optimizing patient management to improve outcomes.

Long-term health outcomes of COVID-19 in ICU- and non-ICU-treated patients up to 2 years after hospitalization: a longitudinal cohort study (CO-FLOW)

BackgroundMany patients hospitalized for COVID-19 experience long-term health problems, but comprehensive longitudinal data up to 2 years remain limited. We aimed to (1) assess 2-year trajectories of health outcomes, including comparison between intensive care unit (ICU) treated and non-ICU-treated patients, and (2) identify risk factors for prominent health problems post-hospitalization for COVID-19.MethodsThe CO-FLOW multicenter prospective cohort study followed adults hospitalized for COVID-19 at 3, 6, 12, and 24 months post-discharge. Measurements included patient-reported outcomes (a.o., recovery, symptoms, fatigue, mental health, sleep quality, return to work, health-related quality of life [HRQoL]), and objective cognitive and physical tests. Additionally, routine follow-up data were collected.Results650 patients (median age 60.0 [IQR 53.0–67.0] years; 449/650 [69%] male) surviving hospitalization for COVID-19 were included, of whom 273/650 (42%) received ICU treatment. Overall, outcomes improved over time. Nonetheless, 73% (322/443) of patients had not completely recovered from COVID-19, with memory problems (274/443; 55%), concentration problems (259/443; 52%), and dyspnea (251/493; 51%) among most frequently reported symptoms at 2 years. Moreover, 61% (259/427) had poor sleep quality, 51% (222/433) fatigue, 23% (102/438) cognitive failures, and 30% (65/216) did not fully return to work. Objective outcome measures showed generally good physical recovery. Most outcomes were comparable between ICU- and non-ICU-treated patients at 2 years. However, ICU-treated patients tended to show slower recovery in neurocognitive symptoms, mental health outcomes, and resuming work than non-ICU-treated patients, while showing more improvements in physical outcomes. Particularly, female sex and/or pre-existing pulmonary disease were major risk factors for poorer outcomes.Conclusions73% (322/443) of patients had not completely recovered from COVID-19 by 2 years. Despite good physical recovery, long-term neurocognitive complaints, dyspnea, fatigue, and impaired sleep quality persisted. ICU-treated patients showed slower recovery in neurocognitive and mental health outcomes and resumption of work. Tailoring long-term COVID-19 aftercare to individual residual needs is essential. Follow-up is required to monitor further recovery.Trial registration: NL8710, registration date 12-06-2020.

Goals of Surgical Interventions in Youths Receiving Palliative Care

Most youths receiving palliative care undergo many surgical interventions over their lifetimes. The intended purposes of interventions in the context of goals of care are not commonly articulated. To describe the goals and purposes of surgical intervention in youths receiving palliative care and propose a framework discussing intervention using goal-oriented language. This retrospective cohort analysis was conducted among a subset of patients enrolled between April 2017 and March 2021 in a prospective multicenter cohort study of youths receiving palliative care (the Pediatric Palliative Care Research Network's Shared Data and Research [SHARE] Study). Patients younger than 30 years receiving palliative care services were eligible for inclusion in SHARE, and all enrolled at Boston Children's Hospital/Dana Farber Cancer Institute, a SHARE site, were included in this study. Goals and purposes of all surgical interventions from the time of diagnosis through the present were abstracted from patient records. A goal and purpose framework was generated using a hybrid deductive-inductive approach based on established goals-of-care frameworks and the clinical context of surgical interventions. Data were analyzed in September 2023. Primary outcomes included goals and purposes of surgical interventions performed in the study population. Among 197 youths receiving palliative care (mean [SD] age at palliative care start, 8.01 [7.53] years; 108 male [54.8%]; 6 Asian [3.0%], 12 Black [6.1%], 129 White [65.5%], and 16 with >1 race [8.1%]; 27 Hispanic [13.7%] and 142 not Hispanic [72.1%]), almost all individuals (189 youths [95.9%]) underwent at least 1 surgical intervention (mean [SD] 17.5 [16.3] interventions; median [IQR] 13 [5-22] interventions). Of 3331 surgical interventions, there were 878 interventions (26.5%) conducted with the goal of life extension, 1229 interventions (37.1%) conducted for life enhancement, and 79 interventions (2.4%) conducted for both goals; the remaining 1130 interventions (34.1%) held neither goal. Most interventions were performed with the purpose of diagnosis (1092 interventions [32.9%]) or cure and repair (1055 interventions [31.8%]), with fewer performed for the purpose of placing or maintaining assistive technology (696 interventions [21.0%]) or for supportive (434 interventions [13.1%]) or temporizing (39 interventions [1.2%]) purposes. Patients with cardiovascular disease and cancers constituted approximately half (592 patients [56.1%]) of those undergoing curative or repair interventions, whereas youths with neurologic or genetic conditions constituted approximately half (244 patients [56.2%]) of those undergoing supportive interventions. In this cohort study, nearly all youths underwent surgical intervention, and the purposes of intervention differed by serious illness type. These findings suggest that conversations centered on a proposed framework concerning goals and purposes of surgical intervention may facilitate goal-concordant, high-quality care for youths with serious illness.

The Association Between Perioperative Red Blood Cell Transfusions and 1-Year Mortality After Major Cancer Surgery: An International Multicenter Observational Study.

Packed red blood cell (pRBC) transfusions in patients undergoing surgery for cancer are given to treat anemia or acute hemorrhage. Evidence indicates that pRBC transfusions are associated with poor perioperative and oncological outcomes. The ARCA-1 (Perioperative Care in the Cancer Patient-1) study was designed to test the association between perioperative pRBC transfusions and postoperative morbidity and mortality in patients undergoing cancer surgery. The primary hypothesis of our study was that perioperative pRBC transfusions have a negative impact on postoperative morbidity and 1-year mortality. ARCA-1 was an international multicenter prospective observational cohort study. Participating centers enrolled a minimum of 30 consecutive adult patients with cancer who underwent surgery with curative intent. The primary end point was all-cause mortality 1 year after major cancer surgery. Secondary end points were rates of perioperative blood product use, 1-year cancer-specific mortality, overall survival, and 30-day morbidity and mortality. We performed a propensity score matching analysis to adjust for selection bias. A multivariable logistic regression model was fitted to estimate the effects of significant covariates on 1-year mortality, cancer-related mortality, and overall survival. A total of 1079 patients were included in the study. The rate of perioperative pRBC transfusions was 21.1%. Preoperative comorbidities, including anemia, American Society of Anesthesiologists (ASA) score of III to IV, a history of coronavirus disease 2019 (COVID-19), myocardial infarction, stroke, need for dialysis, history of blood transfusions, and metastatic disease were statistically significantly more frequent in transfused patients compared to nontransfused patients. The 1-year mortality rate was higher in transfused patients before (19.7% vs 6.5%; P < .0001) and after (17.4% vs 13.2%; P = .29) propensity score matching. 1-year mortality was 1.97 times higher in transfused than in no-transfused patients (odd ratio [OR], 1.97; 95% confidence interval [CI], 1.13-3.41). The odds of 1-year cancer mortality for patients who had perioperative pRBCs was 1.82 times higher (OR, 1.82; 95% CI, 0.97-3.43) compared to those who did not receive perioperative pRBC transfusion. The effect of perioperative pRBC transfusion on overall survival was also significant (hazard ratio [HR], 1.85; 95% CI, 1.15-2.99). Transfused patients also had a higher rate of 30-day postoperative mortality before (3.5% vs 0.7%; P = .0009) and after propensity score matching (4.2% vs 1.8%; P = .34). This international, multicenter observational study showed that perioperative pRBC transfusion was associated with an increased mortality risk.

Prevalence and aggravation of cervical spine instabilities in rheumatoid arthritis during over 10 years: a prospective multicenter cohort study.

We designed a prospective multicenter cohort study to clarify along-term, > 10-year prevalence and aggravation of cervical spine instabilities in rheumatoid arthritis (RA). In 2001-2002, 634 outpatients were enrolled, and 233 (36.8%) were followed for > 10 years. Cervical spine instability was defined as atlantoaxial subluxation (AAS, > 3-mm atlantodental interval), vertical subluxation (VS, < 13-mm Ranawat value), and subaxial subluxation (SAS, ≥ 2-mm irreducible vertebral translation). The aggravation was determined as ≥ 2mm decrease of the Ranawat value in VS, ≥ 2-mm increase of slippage in SAS, and these new developments. The prevalence of VS and SAS increased during both the initial and last > 5 years (all, p ≤ 0.049). While VS aggravation was associated with pre-existing AAS (p = 0.007) and VS (p = 0.002), SAS aggravation correlated with pre-existing VS (p = 0.002). Multivariable analysis found hand mutilating changes (odds ratio [OR] = 4.048, p = 0.008), RA duration ≥ 5 years (OR = 3.711, p = 0.013), C-reactive protein (CRP) level ≥ 3.8mg/dL (OR = 2.187, p = 0.044), and previous joint surgery (OR = 2.147, p = 0.021) as predictors for VS aggravation. Pre-existing VS (OR = 2.252, p = 0.024) and CRP ≥ 1.0mg/dL (OR = 2.139, p = 0.013) were disclosed as predictors for SAS aggravation. Low disease activity and clinical remission before the development of VS and advanced peripheral joint destruction are essential to prevent progressive cervical spine instability in RA.

Smoking behavior and the risks of tumor recurrence and progression in patients with non-muscle-invasive bladder cancer.

Studies on the relationship of cigarette smoking with the risks of recurrence and progression of non-muscle-invasive bladder cancer (NMIBC) are inconsistent and prospective data are scarce. Therefore, we aimed to assess the association of smoking behavior with risks of NMIBC recurrence and progression. We used data of the prospective multi-center cohort study UroLife, including 1495 patients with NMIBC who reported information on smoking at 6 weeks post-diagnosis (baseline; reflecting present and pre-diagnosis). This included smoking status (also based on reporting 3 months post-diagnosis), intensity, duration, pack years, and time since smoking cessation, if applicable. Hazard ratios and 95% confidence intervals (CIs) for risks of first recurrence, multiple recurrences, and progression were computed using multivariable proportional hazards regression models. During a total median follow-up period of 4.6 years, 517 patients developed ≥1 recurrence and 163 had progression. Higher versus lowest categories of smoking intensities and pack years up to baseline were significantly associated with a higher risk of first recurrence. No significant linear associations were found, except for smoking intensity among BCG-treated patients (per 10 cigarettes/day increase: HR 1.23, 95%CI 1.02, 1.48). No associations for smoking status, duration, and time since cessation were observed. Analyses of multiple recurrence risk showed comparable results. Regarding progression risk, no consistent associations were found. In conclusion, heavier smoking was associated with higher recurrence risk, particularly among BCG-treated patients. This may be attributable to persistent damage through its carcinogenic compounds. Given the mixed results across different exposures, the effect of smoking behavior on NMIBC prognosis remains unclear.

Helicobacter pylori prevalence and its spontaneous eradication rate after distal or proximal gastrectomy for gastric cancer: A multicenter prospective cohort study

AbstractBackgroundHelicobacter pylori (H. pylori) eradication is recommended in patients undergoing endoscopic resection for early gastric cancer to reduce recurrence. However, due to the possibility of spontaneous regression secondary to dynamic changes in the remnant stomach, the immediate eradication after gastrectomy for H. pylori carriers remains unclear. This study aimed to investigate the prevalence of H. pylori in Japanese patients with gastric cancer and the spontaneous eradication rate after distal or proximal gastrectomy.MethodsThis multicenter prospective cohort study was conducted at 22 institutions. Eligibility criteria was patients over 20 years planned to undergo R0 gastrectomy for gastric cancer. The primary endpoint was spontaneous eradication rate 1 year after distal or proximal gastrectomy. The prevalence of H. pylori infection before surgery and clinical features related to spontaneous eradication were examined.ResultsA total of 1247 patients were included in this study. The preoperative H. pylori status was positive in 756 patients and negative in 491. Seventy‐nine of the negative patients had an eradication history, totaling 835 (67%) patients preoperatively infected with H. pylori. The infection status of 541 patients was examined 1 year postoperatively; 285 were negative, with a 52.7% spontaneous eradication rate. Spontaneous eradication was significantly higher in male and older patients (&gt;70 years); other factors, such as histological type, gastrectomy method and adjuvant chemotherapy presence, did not affect the rate.ConclusionsAs spontaneous H. pylori eradication occurred in more than half of the analyzed patients, retesting for H. pylori. should be considered before postoperative eradication therapy (UMIN000020280).

Effects of β-blockers on the Outcomes in Patients with Pulmonary Arterial Hypertension Stratified by the Presence of Comorbid Conditions: a Multicenter Prospective Cohort Study (BNP-PL)

The current guidelines do not recommend β-blockers in pulmonary arterial hypertension (PAH) unless indicated by comorbidities. However, the evidence regarding the role of β-blockers in PAH is contradictory. What are the effects of β-blockers on clinical outcomes in patients newly diagnosed with pulmonary arterial hypertension (PAH), and how do these outcomes differ based on the presence of cardiovascular comorbidities that are standard indications for β-blocker use? We analyzed data from 806 patients newly diagnosed with PAH enrolled prospectively in the Database of Pulmonary Hypertension in the Polish Population (BNP-PL). The endpoints were all-cause mortality and a composite of hospitalization due to right heart failure, syncope or death. Indications for β-blocker included hypertension, significant arrhythmia, and coronary artery disease(CAD). Propensity score matching (PSM) was used to form a control group based on age, PAH mortality risk variables and initially introduced PAH specific therapy. Out of the 806 patients, 469 (58.2%) received β-blockers at the time of PAH diagnosis. In PSM, β-blocker treatment showed a higher incidence of the composite endpoint (HR:1.44; 95% CI: 1.04-1.99; P = .03) and had neutral impact on mortality (HR, 1.22; 95% CI, 0.87-1.72; P = .25). When stratified by the presence of comorbidities, β-blockers showed adverse effects on composite endpoint in patients without comorbidities and a neutral effect in patients with at least one comorbidity INTERPRETATION: β-blockers pose significant risks in patients with PAH, especially in patients without coexisting systemic hypertension, CAD and arrhythmia.

Recruiting and retaining healthcare workers in Scotland to a longitudinal COVID-19 study: a descriptive analysis

BackgroundRapid timescales for the design and delivery of research were common during the COVID-19 pandemic. The recruitment and retention of healthcare workers (HCWs) as participants in research studies are notoriously challenging, but this was exacerbated during the pandemic by the unprecedented demand placed on the workforce. The SARS-CoV-2 Immunity and Reinfection Evaluation (SIREN study) is a prospective multicentre cohort study following HCWs in the UK. This paper discusses the strategies and challenges associated with recruitment and retention of HCW participants in Scotland.MethodsThere were 44,546 HCWs recruited to the SIREN study, of whom 6,285 were recruited by research teams at ten different research sites in Scotland between October 2020 and March 2021. Information on target and actual sample size, availability of resource, recruitment rate, and recruitment and engagement strategies by site was collated from SIREN study documentation and discussions with local key SIREN site staff. Individual-level data from 6,153 HCW participants with ongoing consent for all data usage were also collated, including socio-demographic data and information on withdrawal (in first year) and opt-in to a study extension after one year. Factors associated with these outcomes were explored in logistic regression analyses.ResultsDifferent recruitment strategies were used in each site according to local agreements, protocol and staff capacity, with the recruitment period ranging from 13 to 160 days. The locally-agreed recruitment target was met in four sites. The proportion of participants who withdrew in the first year ranged from 3.1 to 24.8% by site, while subsequent opt-in to a 12-month study extension ranged from 28.6 to 74.8%. The sites with the highest proportions of withdrawals were the same four sites with lowest proportions of opt-in. On an individual level, there was a lower level of retention among younger participants, and those from lower socio-economic backgrounds and minority ethnic groups.ConclusionsSite-specific factors including research-readiness likely had a significant influence on recruitment and retention, more so than the specific recruitment or retention strategies employed. Independent of site factors, individual-level variables influenced recruitment and retention, suggesting targeted strategies may be needed to promote research engagement among particular socio-demographic groups.

Patients follow four clusters of participation in physical exercise after an ACL injury. Results from the NACOX cohort study

ObjectivesTo explore how participation in physical exercise (PE) changes over time after an anterior cruciate ligament (ACL) injury. Additionally, to identify factors associated with participation in PE by analyzing longitudinal data. DesignAn explorative analysis of the NACOX study, a prospective multicenter cohort study. MethodsPatients with an acute ACL injury aged 15-40 years were followed for three years. The patients regularly reported participation in PE, knee function, new injuries, and surgeries. State sequence analysis and Hierarchical Cluster Analysis were used to analyze participation in PE. Clusters were compared using an analysis of variances, the Chi-square test, and Fischer’s exact test. ResultsThe study included 275 patients, 52% female, with a mean age of 25 years. Four clusters were identified, varying from low to high participation in PE after an ACL injury. Clusters differed regarding the number of ACL reconstructions (ACLR) (p = 0.03); time from injury to ACLR (p = 0.03); patient-reported knee function at the follow-ups at 3-months (p = 0.02), 6-months (p = 0.02), and 12-months (p = 0.02) after injury; PE level before injury (p < 0.001); and number of new injuries and surgeries (other than ACLR) (p = 0.001). ConclusionFour clusters, varying from low to high participation in PE after an ACL injury were identified. The results provide valuable insight into factors associated with different levels of participation in PE, which can be helpful for healthcare personnel working with ACL rehabilitation.

Clinical and Radiographic Outcomes of a Long Cementless Monobloc Stem for Revision Total Hip Arthroplasty Due to Chronic Periprosthetic Infection

BackgroundA long cementless monobloc stem is widely used for aseptic loosening, with satisfactory five-to-ten-year outcomes reported. Nonetheless, related studies on chronic periprosthetic joint infection (PJI) are scant. This study evaluated the clinical and radiographic outcomes of the stem in two-stage revisions due to PJI. MethodsThis prospective multicenter cohort study consisted of patients from three medical centers who were enrolled in a single arm from January 2017 to May 2022. All patients were diagnosed with chronic PJI based on International Consensus Meeting (ICM) criteria and underwent two-stage revisions using a long monobloc cementless revision stem. Among 44 patients, 37 (12 women and 25 men) completed an average follow-up of 35.6 months (range, 14 to 75). The primary outcome was the stability of the stem; secondary outcomes included infection eradication, Harris hip score, leg length discrepancy, major complications, and isolated pathogens at intraoperative cultures. ResultsAt one year after revision, the infection-free prosthesis survival rate was 97.3% (95% CI [confidence interval]: 96.4 to 98.2%). At the last follow-up, the mean subsidence was 2.9 ± 2.1 mm (range, 0.8 to 4.8). Postoperative leg length discrepancy averaged −4.6 ± 4.9 mm (range, −16 to 0). The Engh score averaged 14.1 ± 6.9 (range, 0 to 22). The Harris hip score improved from a preoperative average of 35.7 ± 8.5 (range, 12 to 50) to 80.4 ± 9.3 (range, 58 to 92) at the 1-year postoperative follow-up (P < 0.01). ConclusionThe long cementless monobloc stem used in the current study presents a feasible option for two-stage revision in cases of chronic PJI. The bone ingrowth and stability could be observed within the short follow-up time.

Effects of Social Determinants of Health and Social Support on Surgical Outcomes Among Patients Undergoing Hysterectomy.

To describe composite 30-day postoperative complication rates among patients undergoing hysterectomy during the coronavirus disease 2019 (COVID-19) pandemic and to determine baseline and postoperative mental health symptoms, levels of social support, and socioeconomic status and their association with hysterectomy outcomes. This multicenter prospective cohort study at eight centers across the United States enrolled patients who underwent minimally invasive hysterectomy for benign indications during the COVID-19 pandemic. Patients completed preoperative and postoperative surveys assessing mental health (PHQ-9 [Patient Health Questionnaire]), social support (MOS-SS [Medical Outcomes Study Social Support Survey]), and socioeconomic status (Hollingshead Index [Hollingshead Four Factor Index of Socioeconomic Status]). Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection rates and 30-day composite complication rates were measured and categorized by Clavien-Dindo Grade. Bivariate associations of survey data on complications were assessed. Logistic regression analyses were used to identify independent predictors of 30-day complications and complication severity. Postoperative complications within 30 days occurred in 67 of 273 (24.5%) patients. Most (88.1%) complications were mild, but eight (11.9%) experienced severe complications. Only three patients (1.1%) tested positive for SARS-CoV-2 infection. There were no differences in complication rates when comparing race and ethnicity, age, or socioeconomic status. Survey responses that indicated more depression and worse support from preoperative to postoperative were seen in patients with severe complications (P=.008 and P=.09, respectively). Multivariate analysis demonstrated that an increase in support scores was protective against severe complications (P=.02). Worsening depression scores were associated with more severe complications (P=.03). This study showed a high rate of complications (24.5%) among patients who underwent hysterectomy during the COVID-19 pandemic. Lower social support and worse mental health status are associated with worse postoperative outcomes after hysterectomy.

Postoperative lymphopaenia as a risk factor for postoperative infections in cancer surgery: A prospective multicentre cohort study (the EVALYMPH study).

Stress due to surgical trauma decreases postoperative lymphocyte counts (LCs), potentially favouring the occurrence of postoperative infections (PIs). We aimed to determine whether postoperative lymphopaenia following thoracic or gastrointestinal cancer surgery is an independent risk factor for PIs and to identify modifiable factors related to anaesthesia and surgical procedures that might affect its occurrence. The EVALYMPH study was a prospective, multicentre cohort study with a 30-day patient follow-up. Multivariate analyses were performed to determine the risk factors for PIs and for postoperative lymphopaenia. Patients were included from January 2016 to September 2017 in 25 French centres. Adult patients admitted for thoracic or gastrointestinal cancer surgery were eligible for inclusion. PIs within 30 days after surgery were defined as urinary tract infections, pneumonia, surgical site infections and other infections (bloodstream infections or pleurisy). Of 1207 patients included, 273 (22.6%) developed at least one infection within 30 days after surgery, with a median [IQR] time to onset of 8 [5 to 11] days. An increased risk of PI was significantly associated with an ASA score of IV: hazard ratio (HR) 4.27 (95% confidence interval (CI), 1.87 to 9.72), surgery > 200 min (HR 1.58 (1.15 to 2.17) and lymphopaenia on postoperative day 1 (POD1) (HR 1.56 (1.08 to 2.25). This risk was associated with changes in postoperative LC over time (P = 0.001) but not with preoperative LC (P = 0.536).POD1 lymphopenia was related to patient characteristics and duration of surgery but not to potentially modifiable other surgical or anaesthetics factors. POD1 lymphopaenia was associated with PIs in patients undergoing thoracic or gastrointestinal cancer surgery. To individualise care, patient characteristics and surgery duration should be taken into account. ClinicalTrials.gov Identifier: NCT02799251.