Multicenter Comparative Cohort Study Research Articles

Comparison of morbi-mortality of pancreaticoduodenectomy after preoperative biliary drainage using LAMS versus ERCP: a multicenter comparative cohort study of ACHBT - FRENCH – SFED intergroup.

Comparison of morbi-mortality of pancreaticoduodenectomy after preoperative biliary drainage using LAMS versus ERCP: a multicenter comparative cohort study of ACHBT - FRENCH – SFED intergroup.

An International Multicenter Prospective Study Evaluating the Long-term Oncological Impact of Adjuvant Chemotherapy in ypN+ Rectal Cancer.

To assess the oncological benefit of adjuvant chemotherapy (AC) in node positive (ypN+) rectal cancer after neoadjuvant chemoradiotherapy and radical surgery. The evidence for AC after total mesorectal excision for locally advanced rectal cancer is conflicting and the net survival benefit is debated. An international multicenter comparative cohort study was performed comparing oncological outcomes in tertiary rectal cancer centers from the Netherlands and France. Patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy followed by total mesorectal excision surgery and with positive lymph nodes on histologic examination (ypN+) were included for analysis. Kaplan-Meier curves were generated to compare disease-free (DFS) and overall survival in AC and non-AC groups. Of 1265 patients screened, a total of 239 rectal cancer patients with ypN+ disease were included. Demographic and clinical characteristics were similar in both groups. Higher systemic recurrence rates were observed in the non-AC group compared with those who received AC [32.0% (n=40) vs 17.5% (n=11), respectively, P =0.034]. DFS at 1 and 5 years postoperatively were significantly better in the AC group (92% vs 80% at 1 year; 72% vs 51% at 5 years, P =0.024), whereas no difference in overall survival was observed. In this multicenter comparative cohort study, we identified an oncological benefit of AC in both systemic recurrence and DFS in ypN+ rectal cancer patients. From this data, systemic chemotherapy continues to confer oncological benefit in locally advanced ypN+ rectal cancer.

COVID-19 Infection Risk Following Elective Arthroplasty and Surgical Complications in COVID-19-vaccinated Patients: A Multicenter Comparative Cohort Study.

BackgroundWe aimed to determine symptomatic Coronavirus disease 2019 (COVID-19) rates within 1 month of elective arthroplasty for vaccinated individuals and to determine whether vaccination guarantees protection against COVID-19 after arthroplasty (primary outcome). In addition, the 90-day surgical complications were compared to those of an unvaccinated group (secondary outcome).MethodsA prospective cohort study was conducted on elective joint arthroplasty patients at 3 tertiary hospitals in 2 major cities (Tehran and Isfahan) in our country (Iran). The outcomes of the COVID-19-vaccinated group were assessed between October 2021 and March 2022. Ninety-day surgical complications were compared with a historical cohort of unvaccinated patients treated earlier in the pandemic (April 2020-March 2021).ResultsThe study included 1717 consecutive patients: 962 vaccinated and 755 unvaccinated. In the vaccinated group, 38 patients (3.9%) contracted COVID-19, 4 (10.5%) were hospitalized again, and none required intensive care unit admission. The multivariate logistic regression analysis revealed that COVID-19-positive cases are more likely to be female (odds ratio [OR] = 12.5), to have visitors to their home (OR = 4.7), and to stay longer in the hospital (OR = 1.2) than COVID-19-negative cases. Compared to unvaccinated patients, the postoperative COVID-19 rate was not significantly different (3.9% vs 2.4%, P = .07). The incidence of surgical complications was similar between the 2 groups (P > .05).ConclusionsThe vaccination does not provide a guarantee that a patient will not contract COVID-19 following their arthroplasty surgery, especially in a region with a high rate of COVID-19. We believe reasonable perioperative COVID-19 precautions may be warranted even in vaccinated patients.

Prophylactic Central Nervous System Irradiation Is Not Indispensable in Adult Patients with Acute Lymphoblastic Leukemia: A Multicenter Retrospective Cohort Study

Objective:Studies comparing the efficacy and safety of prophylactic regimens for central nervous system (CNS) involvement in acute lymphoblastic leukemia (ALL) are scarce in adults. This multicenter retrospective study aimed to compare the efficacy of prophylactic regimens with and without CNS irradiation on the development of CNS relapse during follow-up.Materials and Methods:This was a multicenter comparative cohort study. A total of 203 patients were included from four tertiary care centers in Turkey. Patients were divided into two groups according to whether they received CNS irradiation or not. The groups were analyzed retrospectively regarding patient and disease characteristics, with the main focus being CNS relapse.Results:While 105 patients received chemotherapy-based prophylaxis, 98 patients received additional CNS irradiation. These groups were statistically comparable in terms of demographic characteristics and risk factors for CNS involvement. In the irradiation group, patients were younger and had more stem cell transplants. In a median of 23.8 (11.1-62.4) months, there was no difference between the two groups regarding CNS relapse-free survival (log-rank p=0.787).Conclusion:Craniospinal irradiation may not be indispensable for every adult patient with ALL, similarly to pediatric patients. It is crucial to avoid the long-term toxicities of radiation, especially in patients with long life expectancy. Craniospinal irradiation may be reserved for therapeutic use in cases of CNS relapse and prophylaxis for some high-risk patients.

Invasive pulmonary aspergillosis among intubated patients with SARS-CoV-2 or influenza pneumonia: a European multicenter comparative cohort study

BackgroundRecent multicenter studies identified COVID-19 as a risk factor for invasive pulmonary aspergillosis (IPA). However, no large multicenter study has compared the incidence of IPA between COVID-19 and influenza patients.ObjectivesTo determine the incidence of putative IPA in critically ill SARS-CoV-2 patients, compared with influenza patients.MethodsThis study was a planned ancillary analysis of the coVAPid multicenter retrospective European cohort. Consecutive adult patients requiring invasive mechanical ventilation for > 48 h for SARS-CoV-2 pneumonia or influenza pneumonia were included. The 28-day cumulative incidence of putative IPA, based on Blot definition, was the primary outcome. IPA incidence was estimated using the Kalbfleisch and Prentice method, considering extubation (dead or alive) within 28 days as competing event.ResultsA total of 1047 patients were included (566 in the SARS-CoV-2 group and 481 in the influenza group). The incidence of putative IPA was lower in SARS-CoV-2 pneumonia group (14, 2.5%) than in influenza pneumonia group (29, 6%), adjusted cause-specific hazard ratio (cHR) 3.29 (95% CI 1.53–7.02, p = 0.0006). When putative IPA and Aspergillus respiratory tract colonization were combined, the incidence was also significantly lower in the SARS-CoV-2 group, as compared to influenza group (4.1% vs. 10.2%), adjusted cHR 3.21 (95% CI 1.88–5.46, p < 0.0001). In the whole study population, putative IPA was associated with significant increase in 28-day mortality rate, and length of ICU stay, compared with colonized patients, or those with no IPA or Aspergillus colonization.ConclusionsOverall, the incidence of putative IPA was low. Its incidence was significantly lower in patients with SARS-CoV-2 pneumonia than in those with influenza pneumonia.Clinical trial registration The study was registered at ClinicalTrials.gov, number NCT04359693.

Partial Fundoplication is Effective Treatment for Female Patients with Gastroesophageal Reflux and Scleroderma: A Multicenter Comparative Cohort Study.

Patients with scleroderma often suffer from dysphagia and gastroesophageal reflux disease (GERD). Partial fundoplication is a validated anti-reflux procedure for GERD but may worsen dysphagia in scleroderma patients. Its utility in these patients is unknown. Here, we evaluate the efficacy and acceptability of partial fundoplication for the treatment of medically refractory GERD in patients with scleroderma. Analysis of a prospectively maintained database of patients who underwent fundoplication across 14 hospitals between 1991 and 2019. Perioperative outcomes, reintervention rates, heartburn, dysphagia, and patient satisfaction were assessed at 3months, 1- and 3-years post-surgery. A total of 17 patients with scleroderma were propensity score matched to 526 non-scleroderma controls. All underwent a partial fundoplication. Perioperative outcomes including complication rate, length of stay, and need for reoperation were similar between the two groups. Compared to baseline, both groups reported significantly improved heartburn at 3months, 1- and 3-years following partial fundoplication. Surgery was equally effective at controlling heartburn across all follow-up timepoints in patients with or without scleroderma. Dysphagia to solids was more common in patients with scleroderma than controls at 3-months post-surgery, but was not significantly different to controls at 1- and 3-year follow-up. Satisfaction scores were high and comparable between both groups across all postoperative timepoints, with 100% of patients with scleroderma reporting that their initial choice to undergo surgery was correct. Partial fundoplication controls reflux and is associated with a transient period of dysphagia to solids in patients with scleroderma. This approach is safe, effective and acceptable for patients with scleroderma and medically refractory GERD.

Outcomes of radiofrequency ablation by manual versus self-sizing circumferential balloon catheters for the treatment of dysplastic Barrett’s esophagus: a multicenter comparative cohort study

Radiofrequency ablation (RFA) is the preferred ablative modality for treating dysplastic Barrett's esophagus. The recently introduced self-sizing circumferential ablation catheter eliminates the need for a sizing balloon. Although it enhances efficiency, outcomes have not been compared with the previous manual-sizing catheter. We evaluated the comparative safety and efficacy of these 2 ablation systems in a large, multicenter cohort. Patients undergoing RFA at 3 tertiary care centers from 2005 to 2018 were included. Circumferential RFA was performed in a standard fashion, followed by focal RFA as needed. Outcomes were compared between the self-sizing and manual-sizing groups. The primary outcome was the rate of adverse events, including strictures, perforation, and bleeding. Secondary outcomes were procedure time and treatment efficacy, as assessed by rates and time to complete eradication of dysplasia (CE-D) and intestinal metaplasia (CE-IM). Three hundred eighteen patients were included, 90 (28.3%) treated with the self-sizing catheter and 228 (71.7%) with the manual-sizing catheter. Twenty-one patients (6.6%) developed strictures (8 [8.9%] in the self-sizing group and 13 [5.7%] in the manual-sizing group, P= .32). Of the self-sizing strictures, 75% occurred at the 12J dose before widespread adoption of the current 10J treatment standard. One patient developed bleeding, and no perforations were encountered. Procedure time was significantly shorter in the self-sizing group. No significant differences were observed in rates of and time to CE-D and CE-IM. These findings suggest that both systems are comparable in safety and efficacy. The use of the self-sizing system may enhance the efficiency of RFA for treating dysplastic Barrett's esophagus.

Post-stroke pathway analysis and link with one year sequelae in a French cohort of stroke patients: the PAPASePA protocol study

BackgroundStroke is a health problem with serious consequences, both in terms of mortality, and after-effects affecting patient quality of life. Stroke requires both urgent and chronic management involving the entire health care system. Although large variability in the management of stroke patients have been noticed, knowledge of the diversity and the scalability of post-stroke pathways, whether it is the care pathway or the life pathway, is currently not sufficient. Moreover the link between post-stroke pathways and patients sequelae have not been yet clearly defined. All this information would be useful to better target the needs to improve stroke patient management.The purposes are to identify the post-stroke life pathways components associated with sequelae (activity limitations – main purpose, cognitive disorders, anxio-depressive disorders, fatigue, participation restrictions) at 3 months and 1 year post-stroke, to define a typology of life pathways of patients during the post-stroke year and to analyze the social and geographical inequalities in the management of stroke.MethodsDesign: a prospective multicenter comparative cohort study with a follow up to 1 year after the acute episode.Participant centers: 13 hospitals in the Aquitaine region (France).Study population: patients diagnosed with a confirmed ischemic or hemorrhagic stroke included in the Aquitaine Observatory of Stroke (ObA2) cohort and voluntary to participate.Data sources are existing databases (ObA2 database and the French National Health Data System - SNDS) to collect information about care pathways, patient characteristics and stroke characteristics and Ad hoc surveys to collect information about life pathways and post-stroke sequelae. The endpoints of the study are post-stroke activity limitations evaluated by the modified Rankin score, other post-stroke sequelae (Cognitive disorders, anxio-depressive disorders, fatigue, restriction of participation) assessed by standardized and validated scales and Clusters of patients responding to pathways with common or similar characteristics.;DiscussionBy integrating a longitudinal dimension and relying on a large cohort, the project will make it possible to identify the sources of disturbances and the factors favorable to the outcome of the life pathways, important for the planning of the offer and the management of the public policies concerning stroke pathways.Trial registrationClinicalTrials.gov ID: NCT03865173, March 6th, 2019.

Early-Onset Spinal Deformity in Skeletal Dysplasias: A Multicenter Study of Growth-Friendly Systems

PurposeSevere, early-onset spinal deformity is common in patients with skeletal dysplasia. These deformities often present at young ages and are associated with significant pulmonary dysfunction. The objective of this study is to verify the effectiveness of growth-friendly spinal instrumentation systems in promoting growth in patients with skeletal dysplasia and early-onset kyphoscoliosis. MethodsA retrospective, multicenter comparative cohort study was performed. Twenty-three patients identified to have a skeletal dysplasia (SKD) were evaluated for diagnosis, age at treatment, gender, and type of growing rod construct (spine vs. rib constructs). Patients were matched by age and construct type with similarly treated patients with early-onset scoliosis (CON) without skeletal dysplasia. Radiographic parameters including maximum coronal and sagittal Cobb angle with levels, T1–S1 height, and T1–T12 height were measured. ResultsT1–T12 (12.8 vs. 15.2 cm, p = .01) and T1–S1 (21.2 vs. 24.5 cm, p = .05) heights were significantly shorter for the SKD group at implantation, and kyphosis tended to be more severe in children with SKD (p = .80 and .07, respectively). Kyphosis did not improve with treatment. Scoliosis improved (p < .01), and ΔT1–T12 and ΔT1–S1 significantly increased in both groups (p < .01). Complication rates were similar between the two groups; however, patients with SKD had more intraoperative monitoring changes and hardware failures (p < .005). ConclusionAlthough patients with SKD start with shorter spine lengths, gains in spine length appear to be comparable to other forms of EOS. Neuromonitoring changes and implant failures are more common in the SKD group. SignificanceThe effectiveness of growth-friendly techniques in promoting growth in early-onset spinal deformities in patients with skeletal dysplasia has not been previously studied. We report the first comprehensive review of this topic. Growth-friendly techniques are an appropriate treatment option in this patient population.

Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study

BackgroundThe standard aftercare treatment in surgically treated trauma patients with fractures around or in a joint, known as (peri)- or intra-articular fractures of the lower extremities, is either non-weight bearing or partial weight bearing. We have developed an early permissive weight bearing post-surgery rehabilitation protocol in surgically treated patients with fractures of the lower extremities. In this proposal we want to compare our early permissive weight bearing protocol to the existing current non-weight bearing guidelines in a prospective comparative cohort study.Methods/designThe study is a prospective multicenter comparative cohort study in which two rehabilitation aftercare treatments will be contrasted, i.e. permissive weight bearing and non-weight bearing according to the AO-guideline. The study population consists of patients with a surgically treated fracture of the pelvis/acetabulum or a surgically treated (peri)- or intra-articular fracture of the lower extremities. The inclusion period is 12 months. The duration of follow up is 6 months, with measurements taken at baseline, 2,6,12 and 26 weeks post-surgery.Primary outcome measure: ADL with Lower Extremity Functional Scale. Outcome variables for compliance, as measured with an insole pressure measurement system, encompass peak load and step duration.DiscussionThis study will investigate the (cost-) effectiveness of a permissive weight bearing aftercare protocol. The results will provide evidence whether a permissive weight bearing protocol is more effective than the current non-weight bearing protocol.Trial registrationThe study is registered in the Dutch Trial Register (NTR6077). Date of registration: 01–09-2016.

EUS-guided biliary drainage or enteroscopy-assisted ERCP in patients with surgical anatomy and biliary obstruction: an international comparative study.

Background and study aims: How enteroscopy-assisted ERCP (e-ERCP) and endoscopic ultrasound-guided biliary drainage (EUS-BD) compare in patients with surgically altered upper gastrointestinal anatomy is currently unknown. The aims of this study were to compare efficacy and safety of both techniques and study predictors of these outcomes. Patients and methods: This was an international, multicenter comparative cohort study at 10 tertiary centers. Outcomes data included technical success (biliary access with cholangiography and stent placement [when indicated]), clinical success (resolution of biliary obstruction) and adverse events (AEs) (graded according to the ASGE lexicon). Results: A total of 98 patients underwent EUS-BD (n = 49) or e-ERCP (n = 49). Technical success was achieved in 48 (98 %) patients in the EUS-BD group as compared to 32 (65.3 %) patients in the e-ERCP group (OR 12.48, P = 0.001). Clinical success was attained in 88 % of patients in EUS-BD group as compared to 59.1 % in the e-ERCP group (OR 2.83, P = 0.03). Procedural time was significantly shorter in the EUS-BD group (55 min vs 95 min, P < 0.0001). AEs occurred more commonly in the EUS-BD group (20 % vs. 4 %, P = 0.01). However, the majority (90 %) of AEs were mild/moderate. Length of stay was significantly longer in the EUS-BD group (6.6 d vs. 2.4 d, P < 0.0001). Conclusions: EUS-BD can be performed with a higher degree of clinical efficacy and shorter procedure time than e-ERCP in patients with surgically-altered upper gastrointestinal anatomy. Whether or not this approach should be first-line therapy in this patient population is highly dependent on the indication for the procedure, the patient’s anatomy, and local practice and expertise.

Knee osteoarthritis radiographic progression and associations with pain and function prior to knee arthroplasty: a multicenter comparative cohort study

We determined the radiographic osteoarthritic worsening rate prior to knee arthroplasty (TKA) and whether this worsening was associated with worsening pain and function as compared to a non-surgical matched sample. We used the Osteoarthritis Initiative 5-year datasets. Extent of knee OA 2 years prior to total knee arthroplasty (TKA) was matched to knees of persons who did not undergo TKA. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function and Knee injury and Osteoarthritis Outcome Score (KOOS) Pain scales were used to quantify functional deficit and functionally relevant pain respectively. A total of 167 persons with isolated TKA and 300 persons with matched symptomatic knee OA but no TKA were studied. During the 2 years prior to TKA, worsening by at least one Kellgren and Lawrence (KL) grade occurred in 27.4% (95% CI = 20.6-34.2) of the surgical knees compared to 6.6% (95% CI = 3.8-9.4) of matched non-surgical knees. Osteoarthritis radiographic progression was strongly associated with WOMAC Function and KOOS Pain worsening (P < 0.001) in the 2 years prior to TKA. KL worsening was strongly associated with future arthroplasty (Odds ratio = 5.0, 95% CI = 2.6-9.8) after adjustment for potential confounders. Persons undergoing TKA 2 years later had substantial worsening pain and function over the 2-year pre-operative period as compared to a non-surgical sample matched based on KL grades. Almost 30% of persons who elect to undergo TKA undergo rapid disease progression and symptom worsening during the 2 years prior to TKA.

Tuberculosis in pregnancy: The challenges for South Asian countries

Despite tuberculosis (TB) being a global problem, maternal TB remains an unrecognized and underestimated tragedy, especially in South Asian countries. Therefore, we performed a non-systematic review regarding implications of maternal TB on obstetric and perinatal outcomes in the South Asian context. We reviewed original studies, both descriptive and analytical, that originated from South Asian countries following an electronic search supplemented by a manual search. Although relevant studies from developed countries were reviewed, they were not included in the tabulation process because those studies had different socioeconomic/epidemiological background. Diagnosis of TB is often delayed during pregnancy, because of its non-specific symptoms, and overlapping presentation with other infectious diseases. Poverty, undernutrition, lack of social support and poor health infrastructure along with complications of TB and need for prolonged medications lead to increased maternal morbidity and mortality. Maternal TB in general (except lymphadenitis), is associated with an increased risk of small-for-gestational age, preterm and low-birthweight neonates, and high perinatal mortality. These adverse perinatal outcomes are even more pronounced in women with advanced disease, late diagnosis, and incomplete or irregular drug treatment. There could be a synergy of TB, socioeconomic and nutritional factors, which might have contributed to adverse perinatal effects, especially in low-income countries. As active TB poses grave maternal and perinatal risks, early, appropriate and adequate anti-TB treatment is a mainstay for successful pregnancy outcome. The current knowledge gaps in perinatal implications of maternal TB can be addressed by a multicenter comparative cohort study.

Design and rationale of a Prospective, Observational European Multicenter study on the efficacy of acute surgical decompression after traumatic Spinal Cord Injury: the SCI-POEM study

Despite many years of research, there is currently no treatment available that results in major neurological or functional recovery after traumatic spinal cord injury (tSCI). In particular, no conclusive data related to the role of the timing of decompressive surgery, and the impact of injury severity on its benefit, have been published to date. This paper presents a protocol that was designed to examine the hypothesized association between the timing of surgical decompression and the extent of neurological recovery in tSCI patients. The SCI-POEM study is a Prospective, Observational European Multicenter comparative cohort study. This study compares acute (<12 h) versus non-acute (>12 h, <2 weeks) decompressive surgery in patients with a traumatic spinal column injury and concomitant spinal cord injury. The sample size calculation was based on a representative European patient cohort of 492 tSCI patients. During a 4-year period, 300 patients will need to be enrolled from 10 trauma centers across Europe. The primary endpoint is lower-extremity motor score as assessed according to the 'International standards for neurological classification of SCI' at 12 months after injury. Secondary endpoints include motor, sensory, imaging and functional outcomes at 3, 6 and 12 months after injury. In order to minimize bias and reduce the impact of confounders, special attention is paid to key methodological principles in this study protocol. A significant difference in safety and/or efficacy endpoints will provide meaningful information to clinicians, as this would confirm the hypothesis that rapid referral to and treatment in specialized centers result in important improvements in tSCI patients.