Corrigendum to “Etiology of exudative pleural effusion among adults: Differentiating between tuberculous and other causes, a multicenter prospective cohort study” [IJID Regions, volume 12 (2024), 100425]

Simple SummaryIn brief, this is the first prospective study using a multicentric approach to investigate the effectiveness of adjuvant radiotherapy in patients with early squamous cell carcinoma of the oral cavity (T1/2) and the oropharynx (T1) with one single ipsilateral cervical lymph node metastasis (pN1) in terms of overall survival, time to progression, and quality of life. After the inclusion of 209 patients into this prospective multicentric comprehensive cohort study (2009–2021) and analyzing the follow-up data, we can conclude that adjuvant radiotherapy in patients with early squamous cell carcinoma of the oral cavity and oropharynx does not seem to influence overall survival, but it positively affects the time to progression. However, irradiated patients report a significantly decreased quality of life up to three years after therapy compared to the observation group.(1) Background: Evaluation of impact of adjuvant radiation therapy (RT) in patients with oral squamous cell carcinoma of the oral cavity/oropharynx (OSCC) of up to 4 cm (pT1/pT2) and solitary ipsilateral lymph node metastasis (pN1). A non-irradiated group with clinical follow-up was chosen for control, and survival and quality of life (QL) were compared; (2) Methods: This prospective multicentric comprehensive cohort study included patients with resected OSCC (pT1/pT2, pN1, and cM0) who were allocated into adjuvant radiation therapy (RT) or observation. The primary endpoint was overall survival. Secondary endpoints were progression-free survival and QL after surgery; (3) Results: Out of 27 centers, 209 patients were enrolled with a median follow-up of 3.4 years. An amount of 137 patients were in the observation arm, and 72 received adjuvant irradiation. Overall survival did not differ between groups (hazard ratio (HR) 0.98 [0.55–1.73], p = 0.94). There were fewer neck metastases (HR 0.34 [0.15–0.77]; p = 0.01), as well as fewer local recurrences (HR 0.41 [0.19–0.89]; p = 0.02) under adjuvant RT. For QL, irradiated patients showed higher values for the symptom scale pain after 0.5, two, and three years (all p < 0.05). After six months and three years, irradiated patients reported higher symptom burdens (impaired swallowing, speech, as well as teeth-related problems (all p < 0.05)). Patients in the RT group had significantly more problems with mouth opening after six months, one, and two years (p < 0.05); (4) Conclusions: Adjuvant RT in patients with early SCC of the oral cavity and oropharynx does not seem to influence overall survival, but it positively affects progression-free survival. However, irradiated patients report a significantly decreased QL up to three years after therapy compared to the observation group.

BackgroundChildhood obesity has important effects on the onset and development of puberty. Although a number of studies have confirmed the relationship between obesity and precocious puberty, little is known about the pleiotropic genes of obesity and precocious puberty and the interaction between genes and environment. There are four objectives: (1) to analyze the incidence of precocious puberty in the general population in China; (2) to verify the direct effect of obesity on children’s precocious puberty using a variety of methods; (3) to verify the effect of obesity and its risk gene polymorphism on precocious puberty in a prospective cohort study; and (4) to analyze the interaction effect of genes and environment on pubertal development.MethodsWe will conduct a multi-center prospective cohort study in three cities, which are selected in southern, central, and northern China, respectively. Primary schools in these cities will be selected by a stratified cluster random sampling method. Primary school students from grade 1 to grade 3 (6 to 10 years old) will be selected for the cohort with extensive baseline data collection, including assessment of pubertal development, family demographic information, early development, sleep pattern, dietary pattern, and physical activity. Participants will be followed up for at least three years, and long-term follow-up will depend on future funding.DiscussionThe findings of this multicenter prospective population-based cohort study may expand previous related puberty development research as well as provide important information on the mechanism of early puberty. Targeted interventions can also be developed to improve adolescent health problems related to puberty development based on the available evidence.Trial registrationClinicalTrials.gov Identifier: NCT04113070, prospectively registered on October 2, 2019.

IntroductionThe cause of ischaemic stroke at a young age remains unknown in 30% of cases, highlighting the need to identify hidden causes and risk factors in young patients. Transient and...

Antibiotic overtreatment in infants is a significant problem, due to lack of accurate diagnostic tools for late-onset neonatal sepsis (LONS). We aimed to investigate the diagnostic accuracy of presepsin for LONS at initial suspicion. In this multicenter prospective observational cohort study, we consecutively included all term and preterm infants who started on antibiotics empirically for a nosocomial LONS suspicion. Presepsin concentrations were determined at initial LONS suspicion before antibiotic initiation (t = 0), and 12 and 24 h afterwards. Diagnostic accuracy measures for LONS were calculated. A total of 63 episodes of suspected LONS (32 classified as LONS, including 23 culture-positive and 9 culture-negative episodes) in 50 infants were included. Presepsin concentrations were significantly higher in LONS cases compared with non-LONS at all time-points. The AUC for all LONS cases at t = 0 was 0.77 (95% CI 0.66-0.89) and 0.80 (95% CI 0.67-0.92) for culture-positive LONS cases only. Presepsin seems to have insufficient accuracy as single biomarker to serve as a biomarker for ruling out LONS in infants suspected of LONS. Future larger studies are warranted to validate our findings and to investigate the clinical impact of presepsin, in combination with other biomarkers, as diagnostic tool to facilitate decision-making regarding the initiation of antibiotics, thereby supporting antibiotic stewardship. Presepsin seems to have insufficient accuracy as single biomarker for the decision to treat or not at initial suspicion of late-onset neonatal sepsis. This is the first prospective observational cohort study on the diagnostic accuracy of presepsin for late-onset neonatal sepsis consecutively recruiting all infants suspected of late-onset neonatal sepsis, minimizing bias. Future larger studies are warranted to investigate the clinical impact of presepsin in facilitating decision-making regarding the initiation of antibiotics in infants, thereby supporting antibiotic stewardship.

e20516 Background: To explore socio-demographic features and functional dimensions in patients included in a large Moroccan cohort study. Methods: This is the first Moroccan study which was designed to evaluate the quality of life in cancer patients. It is a prospective multicentric cohort study (the 10 existing centers). Patients with breast, cervical, lung or colorectal cancer were included during 2009. EORTC QLQ C30, BR23, CX24 and LC13 questionnaires were used after a transcultural validation. Results: Over 12 months, 2903 patients were included. Breast cancer was the most common (50.4%). Socio-demographic features: The average age at diagnosis was 52.7 years old. Most of them were women (75%). All of patients were Muslims. 75.1% were married. 60% were illiterate. 20% of patients were professionally active and 59.3% were housewives. 27.2% came from rural towns. The socioeconomic status was 65.8% low and 32.4% intermediate. 71.4% of patients had no social welfare. To get to the oncology centers, 77.8% of patients used public transportation while only 0.6% of total cases came in ambulances. The average distance was 150 kilometers. Psychosocial dimensions: For all types of cancer, functional dimensions were noticeably deteriorated with the stage. The lowest scores were observed in lung cancer, whereas the highest ones were for breast cancer. (Emotional function 62.54 vs. 53.05 professional function and leisure 74.14 vs. 42.22 cognitive activity 83.25 vs 26.93 social activity 86,17 vs. 77.69 p&lt;0.001). The financial problems score was higher in lung cancer (68.34). The future perspective was the most affected dimension in QLQ BR23 questionnaire (score40.51), while in QLQ CX24, the sexual enjoyment was the most impacted dimension (score 52.1). Conclusions: In the Moroccan culture, the social relationships the social relationships offset the negative impact of cancer on other functional dimensions. Social activity scores were the less affected. Financial issues are the major concern, resulting in a negative impact on the quality of life of our patients. Finally, over a period of one year, the scores of reported dimensions were significantly improved by the cancer treatment.

Lung cancer risk in non-smoking females with a familial history of cancer: a multi-center prospective cohort study in China

BackgroundIn Ethiopia, little is known about postoperative pain trajectories and possible predictive factors associated with them in patients undergoing surgery following traumatic fractures.MethodsThis multi-center prospective observational cohort study included surgical candidates for traumatic fractures (n = 218). Worst pain intensity was measured with an 11-point numeric rating scale on the first 4 postoperative days and day of hospital discharge. Growth mixture modeling was used to identify subgroups of patients based on their pain trajectories, and logistic regression models to quantify associations between pain trajectories and demographic, clinical, psychological, and life style factors.ResultsTwo postoperative pain trajectory subgroups were identified: rapid pain relief (48% of included individuals) and consistently high pain (52% of included individuals). Sub-analysis stratified by cause of injury demonstrated that higher preoperative pain was an independent risk factor for consistently high postoperative pain regardless of the patient’s injury type: traffic accident (OR = 1.48, 95% CI 1.23–1.79), machine/tool injury or conflict (OR = 1.58, 95% CI 1.11–2.26), or fall (OR = 1.47, 95% CI 1.08–1.99). Moreover, longer surgical time was a risk factor for consistently high postoperative pain among patients who had a fall-related injury (OR = 1.02, 95% CI 1.00–1.03). In contrast, among patients with a traffic-related injury, receiving a nerve block was a protective factor (OR = 0.19, 95% CI 0.04–0.87) compared with general anesthesia.ConclusionHigher preoperative pain and longer surgical time were associated with a consistently high acute postoperative pain trajectory. Clinicians may use these potentially modifiable factors to identify patients at risk for consistently high pain during the early postoperative period.

BackgroundThe clinical benefit of galcanezumab, demonstrated in randomized clinical trials (RCTs), remains to be quantified in real life. This study aimed at evaluating the effectiveness, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic migraine (CM) in a real-life setting.MethodsThis multicenter prospective observational cohort study was conducted between November 2019 and January 2021 at 13 Italian headache centers. Consecutive adult HFEM and CM patients clinically eligible were enrolled and treated with galcanezumab subcutaneous injection 120 mg monthly with the first loading dose of 240 mg. The primary endpoint was the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients after 6 months of therapy (V6). Secondary endpoints were the Numerical Rating Scale (NRS), monthly painkiller intake (MPI), HIT-6 and MIDAS scores changes, ≥50% responder rates (RR), the conversion rate from CM to episodic migraine (EM) and Medication Overuse (MO) discontinuation.ResultsOne hundred sixty-three patients (80.5% female, 47.1 ± 11.7 years, 79.8% CM) were included. At V6, MMDs reduced by 8 days in HFEM and MHDs by 13 days in CM patients (both p < .001). NRS, MPI, HIT-6 and MIDAS scores significantly decreased (p < .001). Ten patients (6.1%) dropped out for inefficacy and classified as non-responders. Patients with ≥50%RRs, i.e. responders, were 76.5% in the HFEM and 63.5% in the CM group at V6. Among CM patients, the V6 responders presented a lower body mass index (p = .018) and had failed a lower number of preventive treatments (p = .013) than non-responders. At V6, 77.2% of CM patients converted to EM, and 82.0% ceased MO. Adverse events, none serious, were reported in up to 10.3% of patients during evaluation times.ConclusionsGalcanezumab in real life was safe, well tolerated and seemed more effective than in RCTs. Normal weight and a low number of failed preventives were positively associated with galcanezumab effectiveness in CM patients.Trial registrationClinicalTrials.govNCT04803513.

Shunting for hydrocephalus can lead to improvement in the quality of life although the latter has been subdued by complications like shunt infection. Established protocols have contributed to the reduction of ventriculoperitoneal shunt (VPS) infections. Previously, we retrospectively demonstrated a low infection rate despite some of the protocol recommendations not being implemented. The aim of this study was to prospectively establish the incidence of shunt infection in the early post-shunt period following our protocol and elucidate on associated risk factors. A multicenter prospective descriptive cohort study of consecutive 209 under-5 children requiring VPS for hydrocephalus was conducted between January 2013 and November 2018. An innovative protocol insisting on intermittent application of povidone-iodine on the skin during the operation was implemented. The patients were followed-up for 3months post-surgery. Included were 211 VPS procedures performed on 209 children. The median age was 9months and 84 were males. Hydrocephalus was non-communicative in 72.0% and aqueductal stenosis was its most frequent cause (84.9%). Most surgeries were performed in the morning (90.5%), electively (95.3%), and for the first time (91%). The median duration of surgery was 65min. Shunt infection rate was 1.9% (n = 4) (95% CI 0.7 to 5.0%) per procedure. The observed infection rate was low. This suggests that the protocol followed captured the most critical components necessary to ensure low infection rates and that simple measures implemented in economically challenged environments may achieve internationally acceptable infection rates.

BackgroundThe clinical results of removal of metal implants after fracture healing are unknown and the question whether to remove or to leave them in is part of discussion worldwide. We present the design of a prospective clinical multicentre cohort study to determine the main indications for and expectations of implant removal, the influence on complaints, the incidence of surgery related complications and the socio-economic consequences of implant removal.Methods/DesignIn a prospective multicentre clinical cohort study at least 200 patients with a healed fracture after osteosynthesis with a metal implant are included for analyzing the outcome after removal. Six hospitals in the Netherlands are participating. Special questionnaires are designed. The follow up after surgery will be at least six months. The primary endpoint is the incidence of surgery related complications. Secondary endpoints are the influence of removal on preoperative symptoms and complaints and the socio-economic consequences.DiscussionBy performing this study we hope to find profound arguments to remove or not to remove metal implants after fracture healing that can help to develop clear guidelines for daily practice.Trial registrationNTR1297, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1297

ABSTRACTObjective: To determine the short-term cognitive and symptomatic outcome following mild traumatic brain injury.Methods: Setting: Emergency Departments of two UK tertiary referral hospitals. Participants: Adult patients presenting to the Emergency Departments of the Royal London Hospital and Salford Royal Hospital with suspected traumatic brain injury within 24 hours and Glasgow Coma Score > 8. A non-TBI comparison group included adult patients with no head or neck injury. Design: Prospective multi-centre cohort study. Main measures: The Standardized Assessment of Concussion (SAC), the Concussion Symptom Inventory (CSI) and total number of symptoms, measured at baseline and 72 hours.Results: This study enrolled 189 patients with and 51 patients without TBI. Patients with TBI had marked cognitive impairment which persisted at 72 hours (SAC score at baseline = 25 [23–27] vs 72 hours = 25 [22–27]; p = 0.1). Patients with TBI had persistent high symptom severity, although this had decreased at 72 hours (CSI score at baseline = 9 [4–22] vs 72 hours = 5 [1–19], p = 0.002). A similar pattern was observed with the total number of symptoms (baseline = 4 [2–8] vs 72 hours = 0 [0–4]; p < 0.001). Patients with TBI had worse neurocognitive function, higher overall symptom severity and higher total number of symptoms compared with patients without TBI. Patients without TBI’ neurocognitive function and symptom severity remained constant, but the number of symptoms reduced between baseline and 72 hours.Conclusion: There is a cognitive deficit and symptom burden in patients with mild TBI presenting to the Emergency Department which persists at 72 hours.

Chronic hepatitis C virus (HCV) infection is related with an increased risk of non-Hodgkin lymphomas (NHL). In indolent subtypes, regression of NHL was reported after HCV eradication with antiviral therapy (AT). In 2008 in Lombardy, a region of Northern Italy, the "Rete Ematologica Lombarda" (REL, Hematology Network of Lombardy-Lymphoma Workgroup) started a prospective multicenter observational cohort study on NHL associated with HCV infection, named "Registro Lombardo dei Linfomi HCV-positivi" ("Lombardy Registry of HCV-associated non-Hodgkin lymphomas"). Two hundred fifty patients with a first diagnosis of NHL associated with HCV infection were enrolled; also in our cohort, diffuse large B cell lymphoma (DLBCL) and marginal zone lymphoma (MZL) are the two most frequent HCV-associated lymphomas. Two thirds of patients had HCV-positivity detection before NHL; overall, NHL was diagnosed after a median time of 11years since HCV survey. Our data on eradication of HCV infection were collected prior the recent introduction of the direct-acting antivirals (DAAs) therapy. Sixteen patients with indolent NHL treated with interferon-based AT as first line anti-lymphoma therapy, because of the absence of criteria for an immediate conventional treatment for lymphoma, had an overall response rate of 90%. After a median follow-up of 7years, the overall survival (OS) was significantly longer in indolent NHL treated with AT as first line (P=0.048); this confirms a favorable outcome in this subset. Liver toxicity was an important adverse event after a conventional treatment in 20% of all patients, in particular among DLBCL, in which it is more frequent the coexistence of a more advanced liver disease. Overall, HCV infection should be consider as an important co-pathology in the treatment of lymphomas and an interdisciplinary approach should be always considered, in particular to evaluate the presence of fibrosis or necroinflammatory liver disease.

The smoking status of kidney transplant recipients and living donors has not been explored concurrently in a prospective study, and the synergistic adverse impact on outcomes remains uncertain. The self-reported smoking status and frequency were obtained from recipients and donors at the time of kidney transplantation in a prospective multicenter longitudinal cohort study (NCT02042963). Smoking status was categorized as "ever smoker" (current and former smokers collectively) or "never smoker." Among 858 eligible kidney transplant recipients and the 858 living donors, 389 (45.3%) and 241 (28.1%) recipients were considered ever smokers at the time of transplant. During the median follow-up period of 6years, the rate of death-censored graft failure was significantly higher in ever-smoker recipients than in never-smoker recipients (adjusted HR, 2.82; 95% CI 1.01-7.87; P=0.048). A smoking history of >20 pack-years was associated with a significantly higher rate of death-censored graft failure than a history of ≤20 pack-years (adjusted HR, 2.83; 95% CI 1.19-6.78; P=0.019). No donor smoking effect was found in terms of graft survival. The smoking status of the recipients and donors or both did not affect the rate of biopsy-proven acute rejection, major adverse cardiac events, all-cause mortality, or post-transplant diabetes mellitus. Taken together, the recipient's smoking status before kidney transplantation is dose-dependently associated with impaired survival.

Frailty is a multidimensional syndrome characterized by loss of physiologic reserve that gives rise to vulnerability to poor outcomes. We aimed to examine the association between frailty and long-term health-related quality of life among survivors of critical illness. Prospective multicenter observational cohort study. ICUs in six hospitals from across Alberta, Canada. Four hundred twenty-one critically ill patients who were 50 years or older. None. Frailty was operationalized by a score of more than 4 on the Clinical Frailty Scale. Health-related quality of life was measured by the EuroQol Health Questionnaire and Short-Form 12 Physical and Mental Component Scores at 6 and 12 months. Multiple logistic and linear regression with generalized estimating equations was used to explore the association between frailty and health-related quality of life. In total, frailty was diagnosed in 33% (95% CI, 28-38). Frail patients were older, had more comorbidities, and higher illness severity. EuroQol-visual analogue scale scores were lower for frail compared with not frail patients at 6 months (52.2 ± 22.5 vs 64.6 ± 19.4; p < 0.001) and 12 months (54.4 ± 23.1 vs 68.0 ± 17.8; p < 0.001). Frail patients reported greater problems with mobility (71% vs 45%; odds ratio, 3.1 [1.6-6.1]; p = 0.001), self-care (49% vs 15%; odds ratio, 5.8 [2.9-11.7]; p < 0.001), usual activities (80% vs 52%; odds ratio, 3.9 [1.8-8.2]; p < 0.001), pain/discomfort (68% vs 47%; odds ratio, 2.0 [1.1-3.8]; p = 0.03), and anxiety/depression (51% vs 27%; odds ratio, 2.8 [1.5-5.3]; p = 0.001) compared with not frail patients. Frail patients described lower health-related quality of life on both physical component score (34.7 ± 7.8 vs 37.8 ± 6.7; p = 0.012) and mental component score (33.8 ± 7.0 vs 38.6 ± 7.7; p < 0.001) at 12 months. Frail survivors of critical illness experienced greater impairment in health-related quality of life, functional dependence, and disability compared with those not frail. The systematic assessment of frailty may assist in better informing patients and families on the complexities of survivorship and recovery.

Vertebral fragility fractures (VFFs) commonly result from low bone mass and microarchitecture deterioration of bone tissue. spinal orthoses are common non-pharmacological options for managing vertebral fracture pain. However, the effects of spinal orthoses on pain, physical functioning, and quality of life (QoL) are still debated. This survey aimed to investigate the patients-reported outcomes of a dynamic spinal orthosis prescribed in the routine clinical practice of VFFs management. This multi-center national-wide prospective cohort study assessed older patients (aged > 60years) diagnosed with acute VFFs and prescribed with a dynamic spinal orthosis (Spinfast®). A survey questionnaire was realized and included sections on patient characterization, osteoporosis characterization, spinal orthosis, clinical outcomes, pain medications, and osteoporosis medications. The questionnaire was administered at baseline and after three months. A total of 68 patients completed the questionnaire at three months. Most patients had one or two VFFs and were treated with pain medications and osteoporosis medications. Compliance and tolerability of the spinal orthosis were assessed, and clinical outcomes such as pain intensity, physical functioning, and QoL were measured. The results showed no significant differences in outcomes between age subgroups. Italian physical medicine and rehabilitation physicians were commonly involved in the management of VFFs patients. Sixty-six patients completed the questionnaire. The results showed that pain intensity, physical functioning and QoL improved after three months of spinal orthosis wearing (p< 0.0001). The correct management of VFFs is mandatory to improve pain and reduce disability, and our findings suggested a positive role of dynamic spinal orthosis to improve the comprehensive management of VFFs patients. However, high-quality research trials are warranted to provide clear recommendations for the correct clinical management of VFF.