Non-interventional Retrospective Study Research Articles

CO6 Clinical and Economic Outcomes of Adult Limb Spasticity Treatment with Botulinum Toxin-a (BONT-A) Products: A Single-Center Non-Interventional Retrospective Study

Effective limb spasticity (LS) treatment combines physiotherapy and BoNT-A. The North Staffordshire Rehabilitation Centre (UK) initiated LS patients on onabotulinumtoxinA (onaBoNT-A) prior to 2017; after, patients were initiated on abobotulinumtoxinA (aboBoNT-A). This study describes real-world outcomes of BoNT-A treatment, pre- and post-2017.

Treatment patterns and outcomes in resectable early stage NSCLC: Interim analysis of a global real-world study.

e18803 Background: Complete surgical resection is the preferred treatment for early stage NSCLC, with adjuvant chemotherapy as the standard of care in resected stage II/III and select stage IB NSCLC. Osimertinib, an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), is approved as adjuvant therapy in patients (pts) with resected stage IB–IIIA EGFR mutation-positive (EGFRm) NSCLC following results from the Phase III ADAURA trial. Understanding real-world clinical outcomes in early stage NSCLC, including EGFRm prevalence, will help inform unmet needs and further development of new treatment strategies in this population. We report interim results from a global non-interventional retrospective study of pts with resectable NSCLC using clinical data from medical records. Methods: Eligible pts (aged ≥18 yrs) had completely resected stage IA–IIIA NSCLC diagnosed between Jan 1, 2014 and Dec 31, 2017 with EGFR test results available and were followed to at least Dec 31, 2020. Primary endpoints included EGFRm prevalence, treatment patterns, and overall survival (OS); disease-free survival (DFS) was an exploratory endpoint estimated by Kaplan-Meier at predefined landmark timepoints. Results: Of 463 pts from 6 countries (31% from Taiwan, 21% Canada, 17% US, 13% Austria, 10% South Korea, 9% France), median age was 66 yrs (range: 33–86); 172 pts (37%) had stage IA NSCLC at initial diagnosis and 291 (63%) had stage IB–IIIA (22% IB, 13% IIA, 10% IIB, 18% IIIA). 213/463 pts (46%) were EGFRm (43% stage IA, 61% IB, 43% IIA, 26% IIB, 47% IIIA), of who 46% were from Taiwan, 21% South Korea, 14% Austria, 8% Canada, 7% US, and 4% France. In pts with EGFRm vs EGFR wild-type (wt) NSCLC, 84/213 (39%) and 83/250 (33%), respectively, received (neo)adjuvant therapy, of who 156/167 pts (93%) had stage IB–IIIA NSCLC. 106/156 pts (68%) had disease recurrence or death from time of surgery; recurrence rates were similar in pts with EGFRm vs EGFRwt NSCLC, though median DFS was longer in the EGFRm group (Table). Recurrence rates were high in both EGFRm and EGFTwt groups, with landmark DFS probability of 72% vs 77% at 12 mo and 29% vs 32% at 60 mo, respectively. Conclusions: In this real-world global study of surgically resected stage IA–IIIA NSCLC in pts who received an EGFR test, nearly half of the study cohort were EGFRm positive, of who 70% were treated in Taiwan/South Korea. The high rate of recurrence in pts with stage IB–IIIA NSCLC despite receiving (neo)adjuvant therapy reinforces the need for early diagnosis and EGFR testing to identify pts who might benefit from EGFR-targeted therapy, helping optimize clinical outcomes.[Table: see text]

Effect of prior olaparib maintenance therapy for platinum sensitive recurrent ovarian cancer on response to subsequent platinum-based chemotherapy.

Several years have passed since olaparib maintenance therapy was approved in patients with platinum sensitive recurrent ovarian cancer (PSROC). We speculated that the response to platinum-based chemotherapy (PBC) would be impaired at the time of recurrence after olaparib maintenance therapy. We conducted a noninterventional retrospective study to clarify this clinical question in a single institution. We included all patients with PSROC who received olaparib after second or later line of PBC between April 18, 2018, and August 31, 2021. We evaluated the effect of olaparib maintenance therapy on PBC after progression. We identified 42 patients who received olaparib maintenance therapy after second or later line of PBC. Twenty-four patients relapsed after olaparib maintenance therapy, and 17 patients received PBC again. Four of 17 patients (complete response 2, partial response 2) responded to the PBC. The median progression-free survival was longer in patients with platinum-free interval ≥12 months than platinum-free interval of 6-12 months (9.7 vs 2.6months, hazard ratio, 0.20: 95% confidence interval, 0.04-0.90; p=0.04). In the patients with PSROC who experienced disease progression after olaparib maintenance therapy, especially in those with platinum-free interval of 6-12 months, the response to subsequent PBC was extremely poor. The efficiency of re-administration of PBC for PSROC patients with a short-term recurrence after olaparib treatment may need to be reconsidered.

Surgical Management and Prognosis of Congenital Choledochal Cysts in Adults: A Single Asian Center Cohort of 69 Cases.

Background The choledochal cyst (CC) is a rare cystic dilatory condition with malignant tendency, which is more frequently reported in children. Surgical resection of cysts can significantly decrease the risk of malignancy and reduce associated complications. However, CC has been paid lesser attention in adults, and its surgical parameters have been frequently reported to be in dispute. This study aimed to report experience associated with the treatment of an adult with CC and to suggest the appropriate parameters for the surgery, including the extent of excision (complete or not), the length of the Y limb, the diameter of the cholangio-intestinal anastomosis (CIA), and different operative approaches (open, laparoscopic, and laparoscopic converted to open) by comparing the various indicators, including postoperative bile leakage, cholangitis, choledocholithiasis, carcinogenesis, and surgical re-excision. Methods We conducted a single-center noninterventional retrospective study of 69 different congenital choledochal cyst patients who were admitted to our hospital between July 2010 and July 2020. We collected and analyzed their demographic data, clinical presentations, underlying complications, imaging tests, endoscopic interventions, and parameters for the surgery, histological data, and prognostic indicators over a mean 77-month follow-up period. Results We found that out of the 69 cases, the median age at diagnosis was 32 (IQR = 22–45) years. Seven (10.1%) patients were asymptomatic before the diagnosis, with abdominal pain as the primary complaint in 62 (89.9%) patients, whereas nausea/vomiting was observed in 29 (42.0%) patients. CCs were mainly evaluated by using magnetic resonance cholangiopancreatography (MRCP) (n = 47, 68.1%). It was observed that surgery, cholecystectomy, choledochal cysts excision, and Roux-en-Y hepaticojejunostomy (n = 65, 94.2%), and laparotomy (n = 58, 84.1%) were the dominant therapeutic modalities employed. However, seventeen (24.6%) patients were treated with incomplete cyst resection, while 52 (75.4%) patients received complete cyst resection. We also conducted regular follow-ups after the surgery for a mean duration of 77 months. Postoperative complications were found to be experienced by 35 (50.7%) patients, and a further two patients (2.9%) developed malignancy during the follow-up. Moreover, increasing the diameter of cholangio-intestinal anastomosis served as a potential protective factor for postoperative choledocholithiasis (p = 0.040) and a risk factor for cholangitis (p = 0.002). Conclusions Among the 69 CC participants, abdominal pain was their major symptom. Those with an abnormal pancreaticobiliary junction were more likely to have choledocholithiasis and pancreatitis. The diagnosis was found to be highly dependent on the Todani classification scheme and MRCP. Surgical resection remains the key to CC treatment. The results suggested that the complete resection, the length of the Y limb of 40 cm–60 cm, and the diameter of the CIA of 1.0 cm–1.5 cm were appropriate values for predicting the lower risk of postoperative complications.

A retrospective cohort study on European Reference Network for Rare Vascular Diseases 5 outcome measures for Hereditary Haemorrhagic Telangiectasia in Denmark

BackgroundHereditary Haemorrhagic Telangiectasia (HHT) is an autosomal dominant disorder characterized by several clinical symptoms including epistaxis, arteriovenous malformations (AVM), and telangiectasia. In 2018, European Reference Network for Rare Vascular Diseases (VASCERN) recommended five outcome measures for HHT-patients to guide health care providers, some with limited experience in treating HHT, and thereby maximizing the number of HHT-patients receiving good care. The outcome measures cover the following aspects: (1) 90% of the patients should receive a pulmonary AVM (PAVM) screening; (2) 90% of the patients should receive written advice on nosebleed; (3) 70% should be assessed for iron deficiency; (4) 100% of the patients should receive written advice on antibiotic (AB) prophylaxis prior to dental and surgical procedures, and (5) 100% of relevant patients should receive written advice on pregnancy. We have introduced the outcome measures as Benchmarks in our HHT-centre and wanted to evaluate the extend of implementation we have achieved. We constantly struggle to secure the best possible treatment of our HHT-patients.MethodsThe study was a non-interventional retrospective study. Data was collected manually from patient records and from the Danish HHT-database.ResultsA total of 180 HHT-patients were included, all diagnosed in the period from January 1st, 2016, to December 31st, 2020. All patients were screened for PAVM. We could confirm that 66% of patients who had epistaxis received thoroughly advice. Assessment for iron deficiency was performed in 80% of the adult patients. Thoroughly advice on AB prophylaxis was documented in 75%. Thoroughly advice on pregnancy was documented in 80% of female patients 15–45 years of age. There were no significant differences over time for any of the outcome measures.ConclusionsThe Danish HHT-centre reached the target threshold for outcome measures 1 and 3. It could not be documented that the target thresholds for outcome measures 2, 4, and 5 were achieved. As information and education are a very important part of HHT care, focus on and documentation that all patients receive the relevant advice must be a priority in order to ensure best care.

Olanzapine long-acting injection, discontinuation rates and reasons for discontinuation: 10 years' experience at a UK high-secure hospital.

Background:Olanzapine pamoate has been shown to be an effective second-generation long-acting injection. Its popularity has possibly been adversely affected by the rare incidence of post-injection syndrome (PIS) and the associated requirement to monitor for 3 h after each injection.Objective:This study aimed to collect and present data on the use of olanzapine long-acting injection (OLAI) over a 10-year period in a high-security forensic hospital in South East England.Design:This was a non-interventional retrospective study collecting information from anonymised electronic patient and prescription records. As per hospital Trust guidelines, patient consent to access of hospital records was presumed unless explicitly withdrawn.Method:All patients prescribed OLAI between the years 2009 and 2019 were identified. Data collected included date that OLAI was started, stopped, dose range, side effects and concomitant medication.Results:Of 88 patients who were started OLAI, 45 (51%) continued at month 24. At 60 months, 22 of 70 (31%) patients for whom data were available continued with OLAI. Over 60% of continuers were on higher than recommended doses. Of almost 5000 injections administered, there was 1 episode of PIS.Conclusion:OLAI is an effective treatment for schizophrenia and schizoaffective disorder, especially when used in patients have been able to tolerate the drug and were stabilised on it for 24 months. In over half the patients who continued OLAI, the doses were higher than that recommended by the manufacturer. The incidence of PIS in this study was very low in comparison with other studies.Registration code:2049

Factors Affecting Voriconazole Trough Concentration and Optimal Maintenance Voriconazole Dose in Chinese Children.

Voriconazole is a triazole antifungal agent commonly used for the treatment and prevention of invasive aspergillosis (IA). However, the study of voriconazole's use in children is limited. The present study was performed to explore maintenance dose to optimize voriconazole dosage in children and the factors affecting voriconazole trough concentration. This is a non-interventional retrospective clinical study conducted from 1 January 2016 to 31 December 2020. The study finally included 94 children with 145 voriconazole trough concentrations. The probability of achieving a targeted concentration of 1.0–5.5 µg/mL with empiric dosing increased from 43 (45.3%) to 78 (53.8%) after the TDM-guided adjustment. To achieve targeted concentration, the overall target maintenance dose for the age group of less than 2, 2 to 6, 6 to 12, and 12 to 18 years old was approximately 5.71, 6.67, 5.08 and 3.31 , respectively (p < 0.001). Final multivariate analysis found that weight (p = 0.019), dose before sampling (p < 0.001), direct bilirubin (p < 0.001), urea nitrogen (p = 0.038) and phenotypes of CYP2C19 were influencing factors of voriconazole trough concentration. These factors can explain 36.2% of the variability in voriconazole trough concentration. Conclusion: In pediatric patients, voriconazole maintenance doses under the target concentration tend to be lower than the drug label recommended, but this still needs to be further studied. Age, body weight, dose, direct bilirubin, urea nitrogen and phenotypes of CYP2C19 were found to be influencing factors of voriconazole concentration in Chinese children. The influence of these factors should be taken into consideration during voriconazole use.

Opioid and sedative requirements in extracorporeal membrane oxygenation patients on hydromorphone versus fentanyl.

The extracorporeal membrane oxygenation (ECMO) circuit causes pharmacokinetic alterations of medications which impact drug selection and dosing. Although hydromorphone has a favorable pharmacokinetic profile, it is unclear whether hydromorphone provides better patient-centered benefits compared to fentanyl. The objective of this study is to compare opioid and sedative requirements in ECMO patients started on a fentanyl- versus hydromorphone-based analgesia regimen. This was a non-interventional retrospective cohort study. It was conducted at a single center in the cardiovascular intensive care units and cardiac intensive care units. We included venovenous (VV) or venoarterial ECMO patients. Patients who were started on a fentanyl continuous infusion within 24h of cannulation were compared to patients started on a hydromorphone continuous infusion. A linear mixed effects model was performed to compare doses of opioid, sedative, and propofol between groups over time. We included 28 hydromorphone patients and 53 fentanyl patients, with 85% on VV ECMO. There were no differences between hydromorphone and fentanyl groups in opioid or sedative (including propofol and benzodiazepine) doses for any ECMO day (p value for interaction .63 and .83, respectively). Propofol doses alone, however, were significantly higher in the fentanyl group on ECMO days three, four, and five. There appear to be no major differences in opioid or sedative requirements whether ECMO patients are initiated on a hydromorphone- or fentanyl-based regimen.

Free combination of dutasteride plus tamsulosin for the treatment of benign prostatic hyperplasia in South Korea: analysis of drug utilization and adverse events using the National Health Insurance Review and Assessment Service database

ObjectiveTo assess the use and safety of free combination therapy (dutasteride and tamsulosin), dutasteride monotherapy, or tamsulosin monotherapy in patients with benign prostatic hyperplasia (BPH).MethodsThis non-interventional retrospective cohort study used claims data from the Korea Health Insurance Review and Assessment-National Patient Sample database. Patients with BPH ≥ 40 years of age receiving combination therapy (dutasteride 0.5 mg and tamsulosin 0.4 mg daily) or dutasteride 0.5 mg, or tamsulosin 0.4 mg daily dose between 2012 and 2017 were included. The frequency, duration of treatment and risk of any adverse event (AE) or serious AE (SAE) was compared for combination therapy versus each monotherapy using non-inferiority testing.ResultsOf 14,755 eligible patients, 1529 (10.4%) received combination therapy, 6660 (45.1%) dutasteride monotherapy, and 6566 (44.5%) tamsulosin monotherapy. The proportion of patients treated with combination therapy exceeded the pre-specified 3% threshold for ‘frequent’ use. Safety results indicated a similar risk of any AE and SAE irrespective of treatment group. The adjusted relative risk for any AE over the treatment observation period comparing combination therapy with dutasteride monotherapy was 1.07 (95% confidence interval [CI] 1.03, 1.12), and with tamsulosin monotherapy was 0.98 (95% CI 0.95, 1.02) demonstrating non-inferiority. The adjusted relative risk for any SAE was 1.07 (95% CI 0.66, 1.74) and 0.90 (95% CI 0.56, 1.45), compared with dutasteride and tamsulosin monotherapy, respectively. Although the SAE results did not statistically demonstrate non-inferiority of combination therapy based on pre-specified margins, the 95% CI for the risk ratio estimates included the null with a lower limit below the non-inferiority margins, indicating no meaningful differences in SAE risk between groups. Absolute SAE risks were low.ConclusionCombination therapy with dutasteride and tamsulosin is frequently used in real-world practice in South Korea for treatment of BPH and demonstrates a safety profile similar to either monotherapy.

Pulmonary Embolism Detection in COVID-19 Patients

Background: A clinically important impact of Coronavirus Disease 2019 (COVID-19) is the increased likelihood of thromboembolism, mainly pulmonary embolism (PE). To screen for these complications a biochemical marker, D-dimer, is usually done. There is a plethora of research validating the use of D-dimer cutoff levels in non-COVID-19 patients, however less so in the COVID-19 population. Aim: To determine the number of suspected COVID patients with D-dimer ≥ 0.5 and PE reported on CTPA. Methods: Non-interventional single-centre retrospective clinical correlational study. Patient cohort was patients admitted with suspected COVID-19 over a 5-week period. N=690. Results: 76.5% of suspected COVID-19 patients were PCR positive. 40% of these patients had a CTPA completed with 19% reported to have a PE. 52% of patients had a D-dimer value ≥ 0.5 10.6% patients had a PE with a D-dimer ≥ 0.5. Conclusion: Nationally, hospitals are adopting existing D-dimer cut off levels to rule out PEs, however this leads to a large proportion of admitted COVID-19 patients having possibly unnecessary computed tomography pulmonary angiogram. This study highlights that majority of patients with D-dimers above the cut off level have negative PEs and contributes to the notion that standard D-dimer cutoffs are insufficiently accurate to be used as a standalone test in diagnosis in the context of an underlying SARS-CoV-2 infection.

Pathology spectrum of kidney damage in Hodgkin’s lymphoma, non-Hodgkin lymphoma/leukemia, and lymphoplasmacytic lymphoma in the real practice

Background: Kidney damage in lymphomas/leukemia’s presents with either acute kidney injury (AKI), chronic kidney disease (CKD), or both; and whilst AKI leads to evaluation often based on the clinical data, in some AKI and in almost all CKD cases kidney biopsy gives a clue to the diagnosis. Methods: A single center non-interventional retrospective study identified 36 patients with biopsy-proven kidney damage: 6 with Hodgkin’s lymphoma (HL), 18 with non-Hodgkin’s lymphoma/leukemia (NHL/CLL), and 12 with lymphoplasmacytic lymphoma (LPL). Results: Fifty-eight percent males and 42% females mean age 56.2 ± 17.4 years, presented with nephrotic syndrome in 47.2%, and with AKI in 11.1% of cases; 75% of patients diagnosed with CKD; in 13.9% AKI was superimposed on CKD. Patients with NHL/CLL presented with AKI significantly more often compared to HL and LPL—44% versus 16.6% versus 0 respectively. Monoclonal immunoglobulin (MIg) related glomerulopathies (GP) were found in 83.3% versus 16.6% cases in the LPL and NHL/CLL sub-groups, respectively ( p = 0.013). Patterns of damage included intracapillary monoclonal deposition disease, light and heavy chain amyloidosis, monotypic membranous nephropathy (MN), cryoglobulinemic glomerulonephritis (GN) and C3-GN in the LPL; and monotypic MN and proliferative GN with MIg deposits in the NHL/CLL sub-groups respectively. Paraneoplastic GPs were found in 83.3%, 38.8%, and 16.6% of patients with HL, NHL/CLL, LPL, respectively (HL vs LPL, p &lt; 0.001), and included minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and IgA-nephropathy in the HL; membranoproliferative GN, MN, and MCD in NHL/CLL; and FSGS in the LPL sub-groups. Tubulointerstitial damage revealed in NHL/CLL sub-group only, and found in every other case with 80% of lymphoid infiltration. Conclusions: Pattern glomerular damage depends on lymphoma type: paraneoplastic GPs are typical for HL, MIg-related GPs dominate in LPL, NHL/CLL presents mainly as paraneoplastic with single MIg-related patterns. Tubulointerstitial damage due to specific kidney infiltration attributable to NHL/CLL.

Can we trust combined anteversion and Lewinnek safe zone to avoid hip prosthesis dislocation?

IntroductionDislocation is one of the most common complications after primary total hip arthroplasty (THA). Combined anteversion (CA) is currently considered one of the most important measures of stability for THA. Thus, the aim of this study is to determine the association between a correct CA after THA and hip prosthesis dislocation, and to analyze the reliability of the Lewinnek safe zone parameters. Material and methodsThis is a non-interventional retrospective study, carried out at a tertiary hospital in Spain. 2489 primary THA in 2147 patients between January 2008 and December 2014 were identified. Clinical, biological and radiographic data, including cup inclination and cup and femoral anteversion, were analyzed of all patients who developed a hip prosthesis dislocation. ResultsThirty-four patients met the eligibility criteria to be analyzed. In 73.5% (25/34) of cases, acetabular anteversion (AV) was correct, with a mean AV of 15.1° ± 9.4°. Femoral anteversion (FA) was considered correct only in 38.2% (13/34) of the dislocated THA, with a mean FA of 8.4° ± 17.2°. Sixteen of these 34 patients (47.0%) presented a correct CA, with a mean CA of 24.2° ± 21.0°. Nineteen hips (55.8%) were within the Lewinnek safe zone. Moreover, eleven patients (32.3%) developed a dislocation even though components were within the Lewinnek safe zone and presented a correct CA. ConclusionOur findings suggest that even when the THA components are positioned within a correct CA and in the Lewinnek safe zone, hip prosthesis dislocations can occur in a not inconsiderable percentage of the cases. Thus, further radiological and clinical analysis should be done to identify potential reasons for hip prosthesis dislocation.

Ocular surface squamous neoplasia in New Zealand: a ten-year review of incidence in the Waikato region.

Ocular surface squamous neoplasia (OSSN) is a relatively rare disease with a low mortality and highly variable incidence. Despite a high incidence of OSSN in the Southern hemisphere, there is limited epidemiological data for New Zealand. The current study aims to assess the incidence, demographics, and histological grade of OSSN in the Waikato region of New Zealand, home to ~10% of the population of New Zealand. Non-interventional retrospective cohort study. All conjunctival biopsy histology reports from 2010 to 2019 in the Waikato region of New Zealand were analysed. Age, sex, and ethnicity were analysed and the incidence of OSSN was calculated. Main outcome measures included histological grade, rate of recurrence, and incidence of OSSN. A total of 386 patients underwent conjunctival biopsy with histology during the study period. Eighty-three lesions (22%) involving 80 patients (21%) werereported positive for OSSN. Patients with OSSN had a mean age of 68.9 years (SD = 13.2), were predominantly male (76%), and of New Zealand-European ethnicity (53%). Conjunctival intraepithelial neoplasia-1 (30%) was the most frequent diagnosis. Three patients (4%) had recurrent lesions requiring repeat biopsy. The peak annual OSSN incidence rate was 3.81/100,000 population in 2019. The overall ten-year incidence was 2.13/100,000 population/year. This is the largest study to investigate OSSN incidence in New Zealand. The incidence rate of OSSN is one of the highest rates reported in the literature.

Feasibility of ABUS as an Alternative to Handheld Ultrasound for Response Control in Neoadjuvant Breast Cancer Treatment

IntroductionThe Invenia Automated Breast Ultrasound Screening (ABUS) is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women with high-density breast tissue. ABUS provides time-efficient evaluation of the 3-dimensional recordings within 3 to 6 minutes. The role and advantages of ABUS in everyday clinical practice, especially in routine examination during neoadjuvant chemotherapy (NACT), is not clear. The aim of this monocentric, noninterventional retrospective study is to evaluate the use of ABUS in patients who are under NACT treatment for response control. MethodsRegular sonographic response check with handheld ultrasound (HHUS) examination and with ABUS were conducted in 83 women who underwent NACT. The response controls were conducted every 3 to 6 weeks during NACT. The handheld sonography was performed with GE Voluson S8. Handheld sonographic measurements and ABUS measurements were compared with the final pathologic tumor size. ResultsThere was no statistical difference between the measurements with HHUS examination or ABUS compared with final pathologic tumor size (P = .47). The average difference from ABUS measured tumor size to final pathologic tumor size was 9.8 mm. The average difference from handheld measured tumor size to final pathologic tumor size was 9/3 mm. Both the specificity of ABUS and HHUS examination in predicting pathologic complete remission was 100%. ConclusionABUS seems to be a suitable method to conduct response control in neoadjuvant breast cancer treatment. ABUS may facilitate preoperative planning and offers remarkable time saving for physicians compared with HHUS examination and thus should be considered for clinical practice

Diagnosis and Prognosis of Retroperitoneal Liposarcoma: A Single Asian Center Cohort of 57 Cases.

Background Liposarcoma is a soft tissue malignancy, commonly observed in the extremities. However, retroperitoneal liposarcoma is seldom reported and its diagnosis is frequently neglected. This study aims to present the clinical characteristics, diagnosis, and prognosis of five liposarcoma subtypes and report our experience of patient treatment. Methods We conducted a single-center noninterventional retrospective study of 57 retroperitoneal liposarcoma patients admitted to Peking Union Medical College Hospital (PUMCH, Beijing, China) between July 2011 and December 2019. We collected and analyzed their demographic, clinical, imaging, histological, therapeutic, and prognostic data over a mean 4.5-year follow-up period. Results Twenty-five (44%) patients were asymptomatic prior to diagnosis, with abdominal distension as the chief complaint in 18 (32%) patients and abdominal pain observed in 16 (28%) patients. Masses were evaluated by computed tomography (n = 48, 84%) or ultrasound (n = 25, 44%). Laparotomy (n = 52, 91%) was the dominant therapeutic modality rather than laparoscopy (n = 5, 9%). All patients were treated with R0 resection except two patients who underwent R2 resection. We conducted regular follow-ups every six months after surgery for a mean duration of 4.5 years. Recurrence was experienced by 14 (25%) patients and a further 9 (16%) died during follow-up. Conclusions Abdominal distension and pain are chief complaints with liposarcoma. As the extremities are the main liposarcomas locations, the diagnosis of retroperitoneal liposarcoma is usually neglected. Since half of the patients are asymptomatic, timely diagnosis and treatment are highly dependent on regular ultrasound and computed tomography imaging. R0 resection is the key to retroperitoneal liposarcoma treatment. In comparison, patients who underwent R2 resection, which is considered a palliative treatment, had bad prognoses. Large, symptomatic dedifferentiated, and pleomorphic liposarcomas are more likely to have poor prognoses, while the prognosis for well-differentiated or myxoid liposarcoma is relatively good.

Direct anterior approach provides better functional outcomes when compared to direct lateral approach in hip hemiarthroplasty following femoral neck fracture.

This study aims to compare the differences between direct anterior approach (DAA) and direct lateral approach (DLA) in hip hemiarthroplasty (HHA) after displaced femoral neck fracture (FNF) in early functional outcome, hospital length of stay, morbidity and mortality rates. This non-interventional retrospective study, carried out at a tertiary trauma centre within the Spanish National Health System, included all patients who underwent a bipolar HHA between 1st January 2018 and 31st December 2019 performed by 2 of our hip unit surgeons. A total of 94 patients were included (40 in DAA group and 54 in DLA group). Median follow-up was 19.2months (range 8-30.8months). Postoperative degree of mobilisation showed statistically significant differences in favour of DAA group, where 35% of patients were able to walk with no assistance after surgery. DAA group had 1day less of hospitalisation in contrast with DLA group overall (8days vs 9days, respectively, p < 0.05). Statistically significant differences were not detected in comparing postoperative complications, re-operations rates or 6-months mortality rate. Our study highlights the benefits of DAA for HHA after displaced FNF in terms of postoperative mobilisation degree and hospitalisation length of stay when compared to DLA.

The significance of low first trimester serum progesterone in ongoing early pregnancies presenting as pregnancies of unknown location

ObjectivesThe primary objective of this study was to ascertain whether there is association between low initial serum progesterone, sonographic parameters and clinical outcomes in women presenting with pregnancies of unknown location (PUL), which are found to be ongoing at their follow up scans in the first trimester. Study designThis was a non-interventional retrospective cohort study of 1056 patients spanning a 14-year period, conducted in the Early Pregnancy Unit (EPU) of an inner-city teaching hospital. Patients who had an ongoing singleton first trimester pregnancy after presenting with PUL were identified and categorised as having low progesterone if it was 32 nmol/l or lower. The crown-rump length (CRL), mean gestational sac diameter (MGSD) and gestational sac volume (GSV) were measured when the embryo was first seen, and the pregnancy outcome recorded. ResultsPregnancies with low progesterone tended to have smaller gestational sacs (GS) on follow up scan (p = 0.001) and the sac was smaller than expected for a given CRL (p = 0.000). There was no ultrasound parameter that was characteristic of low progesterone. The observation of a smaller than expected MGSD for a given CRL remained even when only pregnancies with normal outcomes were analysed. Clinical outcome data were available for 854 (80.9 %) women. Overall, 81.4 % (n = 34/43) of pregnancies with low progesterone resulted in livebirth, compared to 91.7 % (n = 744/811) livebirths in pregnancies with higher levels (p = 0.0454). ConclusionPregnancies with low progesterone tend to have a smaller GS compared to those with a higher progesterone, and the GSs are smaller than expected for a given CRL. The current study shows that women with low progesterone at the start of pregnancy remain at higher risk of miscarriage, even when the pregnancy is initially found to be viable in the first trimester. These pregnancies also tend to be associated with the sonographic finding of a smaller GS than expected for a given gestational age, regardless of eventual outcome.

Treatment patterns, clinical outcomes, and healthcare resource use associated with advanced/metastatic lung cancer in China: protocol for a retrospective observational study.

BackgroundLung cancer (LC) is the most common cancer worldwide. The prevalence of LC and rate of associated mortality are high and increasing faster in China than in Western countries. Non-small cell lung cancer (NSCLC) accounts for most LCs. This study aims to be the first large, multi-center, non-interventional retrospective study of treatment patterns (type/duration, number of lines, completion rate), real-world outcomes, and medical costs among Chinese patients with advanced/metastatic NSCLC (IIIb/IV) or extensive-stage small cell LC (ES-SCLC).MethodsThis study will enroll 8,800 patients (≥18 years, with a diagnosis of advanced/metastatic NSCLC made between 1 December 2013 to 30 November 2014) from 35 to 50 Chinese sites. Hospital information systems (HIS) and electronic medical records will be retrospectively reviewed, in adherence with regulatory and ethical requirements. Early-stage treatment (starting from 1 December 2010) of patients with recurrent disease or early disease progression will be examined. Data will be collected at baseline (diagnosis) and 6 and 12 months after this. Observation will end after 3 years or death. Data will be stratified by histology, staging, age, region, health insurance, and epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK) mutation status. Treatment duration and overall survival will be estimated using Kaplan-Meier curves. Descriptive statistics will be used for disease characteristics and patient demographics. Cox-proportional hazards models will be used to examine the impact of demographics/treatment on survival. Treatment patterns and outcome predictors will be explored using multivariate logistic regression.DiscussionThis protocol describes the methodology for collecting real-world data to guide evidence-based clinical practice and inform unmet needs in NSCLC treatment, with potential to identify gaps between guidelines and current practice.Trial registrationNCT03505515; data registered on ClinicalTrials.gov: 12h Apr., 2018.

Italian Observational Study on Real-Life Use of Venetoclax in Acute Myeloid Leukemia (AVALON study): Results of Interim Analysis on Relapsed/Refractory Patients

Italian Observational Study on Real-Life Use of Venetoclax in Acute Myeloid Leukemia (AVALON study): Results of Interim Analysis on Relapsed/Refractory Patients

Nosocomial infection with SARS-CoV-2 and main outcomes after surgery within an orthopaedic surgery department in a tertiary trauma centre in Spain.

AimsThe purpose of the present study is to analyse clinical data of a series of cases who developed nosocomial infection with SARS-CoV-2 in an orthopaedic and traumatology department.Patients and methodsIn this non-interventional retrospective study, carried out at a tertiary hospital within the Spanish National Health System, all adult patients who were admitted in the Orthopaedic Surgery and Traumatology Department between March 9th and May 4th, 2020, were included. Clinical, biological and radiological data, as well as mortality rates, were collected from hospital medical records.ResultsA total of 293 periods of hospitalization were analysed in 288 patients. Mean age was 66.1 years old and 57.3% were females. Nineteen patients (6.48%) met the inclusion criteria to be categorized as a nosocomial infection with SARS-CoV-2. In a comparison between patients with and without nosocomial infection, age, mortality and hospital length of stay were statistically significant (p < 0.05). The median time from admission to diagnosis of SARS-CoV-2 infection in our cohort was 16 days (6–86 days). No statistically significant differences were found in sex, living situation, reason of admission or period of admission (even if we observed that most of the nosocomial infections (78.9%) occurred in March).ConclusionWe have found a 6.48% of nosocomial infection with SARS-CoV-2, but with an important reduction of it after undergoing preventing protocols that included screening RT-PCR test for COVID-19. Age and hospital length stay were statistically significant risk factors for nosocomial infection with SARS-CoV-2. For the progressive restoration of the surgical activity, we recommend to correctly select the patients in elective surgery and to encourage fast-track programs and early discharge of patients with fractures.