scholarly journals Assessing the Long-Term Role of Vaccination against HPV after Loop Electrosurgical Excision Procedure (LEEP): A Propensity-Score Matched Comparison

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 717
Author(s):  
Giorgio Bogani ◽  
Francesco Raspagliesi ◽  
Francesco Sopracordevole ◽  
Andrea Ciavattini ◽  
Alessandro Ghelardi ◽  
...  

Background: Primary prevention through vaccination is a prophylactic approach aiming to reduce the risk of developing human papillomavirus (HPV)-related lesions. No mature and long-term data supported the adoption of vaccination in women undergoing conization. Methods: This is a retrospective multi-institutional study. Charts of consecutive patients undergoing conization between 2010 and 2014 were collected. All patients included had at least 5 years of follow-up. We compared outcomes of patients undergoing conization plus vaccination and conization alone. A propensity-score matching algorithm was applied in order to reduce allocation biases. The risk of developing recurrence was estimated using Kaplan-Meir and Cox hazard models. Results: Overall, charts of 1914 women were analyzed. The study group included 116 (6.1%) and 1798 (93.9%) women undergoing conization plus vaccination and conization alone, respectively. Five-year recurrence rate was 1.7% (n = 2) and 5.7% (n = 102) after conization plus vaccination and conization alone, respectively (p = 0.068). After the application of a propensity-score matching, we selected 100 patients undergoing conization plus vaccination and 200 patients undergoing conization alone. The crude number of recurrences was 2 (2%) and 11 (5.5%) for patients undergoing conization plus vaccination and conization alone, respectively (p = 0.231). Vaccination had no impact on persistent lesions (no negative examination between conization and new cervical dysplasia; p = 0.603), but reduced the risk of recurrent disease (patients who had at least one negative examination between conization and the diagnosis of recurrent cervical dysplasia; p = 0.031). Conclusions: Patients having vaccination experience a slightly lower risk of recurrence than women who had not, although not statistically significantly different. Further evidence is needed to assess the cost effectiveness of adopting vaccination in this setting.

2020 ◽  
Vol 7 (1) ◽  
pp. e000412
Author(s):  
Murray B Urowitz ◽  
Robert L Ohsfeldt ◽  
Ronald C Wielage ◽  
John J Dever ◽  
Mehdi Zakerifar ◽  
...  

ObjectiveLong-term extension (LTE) studies of belimumab in SLE do not include a comparator arm, preventing comparisons between belimumab plus standard therapy and standard therapy alone for organ damage accrual. Propensity score matching can be used to match belimumab-treated patients from LTE studies with standard therapy–treated patients from observational cohort studies. This analysis was designed to compare organ damage progression between treatment groups (belimumab plus standard therapy vs standard therapy alone) in patients with SLE with ≥5 years of follow-up, reproducing our previous study with more generalisable data.MethodsThis exploratory post hoc analysis used a heterogeneous population of US and non-US patients receiving monthly intravenous belimumab from pooled BLISS LTE trials (BEL112234/NCT00712933) and standard therapy–treated patients from the Toronto Lupus Cohort. Sixteen clinical variables were selected to calculate the propensity score.ResultsThe 592 LTE and 381 Toronto Lupus Cohort patients were highly dissimilar across the 16 variables; an adequately balanced sample of 181 LTE and 181 matched Toronto Lupus Cohort patients (mean bias=3.7%) was created using propensity score matching. Belimumab treatment was associated with a smaller increase in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) over 5 years than standard therapy alone (mean treatment difference=–0.453 (95% CI –0.646 to –0.260); p<0.001). Patients treated with belimumab were 60% less likely to progress to a higher SDI score over any given year of follow-up, compared with standard therapy alone (HR (95% CI) 0.397 (0.275 to 0.572); p<0.001).ConclusionUsing propensity score matching, this highly heterogeneous sample was sufficiently matched to the Toronto Lupus Cohort, suggesting that patients treated with intravenous belimumab may have reduced organ damage progression versus standard therapy alone. This analysis of a large and diverse pooled SLE population was consistent with our previously published US-focused study.


2019 ◽  
Vol 14 (1) ◽  
Author(s):  
Xian Wang ◽  
Yifan Zhu ◽  
Wen Chen ◽  
Liangpeng Li ◽  
Xin Chen ◽  
...  

Abstract Background Mild preoperative renal dysfunction (RD) is not rare in patients receiving isolated cardiopulmonary coronary artery bypass grafting (CCABG). However, there are not too many studies about the impact of mild preoperative RD on in-hospital and follow-up outcomes after isolated CCABG. This single-centre, retrospective propensity score matching study designed to study the impact of mild preoperative RD on in-hospital and long-term outcomes after first isolated CCABG. Methods After propensity score matching, 1144 patients with preoperative estimated glomerular filtration rate (eGFR) of more than 60 ml/min/1.73 m2 receiving first isolated CCABG surgery from January 2012 to December 2015 entered the study, who were divided into 2 groups: A group (eGFR ≥90 ml/min/1.73 m2, n = 572) and B group (eGFR of 60–89 ml/min/1.73 m2, n = 572). The in-hospital and long-term outcomes were recorded and analyzed. The mean follow-up time was 54.4 ± 10.7 months. Acute kidney injury (AKI) was defined and classified according to the Acute Kidney Injury Network (AKIN) criteria. Results The 2 propensity score-matched groups had similar baseline and procedure except the baseline eGFR. There were 8 patients died in A group (mortality is 1.4%) and 14 died in B group (mortality is 2.5%) during the in hospital and 30-day postoperatively(χ2 = 1.159, p = 0.282). There were totally 38 patients lost to follow-up, 18 in group A and 20 in group B. 21 patients died in group A and 37 died in group B during the follow-up, and long-term survival in group A was higher than in group B (96.2% vs 93.1%, χ2 = 4.336, p = 0.037). Comparing with group A, group B was associated with an increased rates and severity of AKI postoperatively (total AKI: 62 vs 144. AKIN stageI: 54 vs 113; AKIN stageII: 6 vs 22; AKIN stageIII: 2 vs 9, p<0.0001). During follow-up, group B also had a higher rate of new onset of dialysis (0 vs 6, χ2 = 4.432, p = 0.039). Multivariable logistic regression showed that comparing with A group, the HR for long-term mortality and new onset of dialysis in B group was 1.67 and 1.52 respectively (95%CI 1.09–2.90, p = 0.035; 95%CI 1.14–2.49, p = 0.027). Conclusions Comparing with normal preoperative renal function, patients with mild preoperative RD had a similar in-hosptial mortality, but with an increased in-hosptial rates and severity of AKI, and with a decreased long-term survival and increased long-term new onset of dialysis.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M.R Grubler ◽  
N.D Verheyen ◽  
A Meinitzer ◽  
L Fiedler ◽  
M Tscharre ◽  
...  

Abstract Background/Introduction Atrial fibrillation (AF) is a common heart rhythm disturbance, associated with an increased risk of stroke, hospital admissions and mortality, especially in patients with reduced ejection fraction. Among the oldest medications used for heart-rate control is digitalis, but largely due to observational studies showing an increased risk of death it has fallen out of favour. Recently newer clinical trials reported that the treatment with digitalis in permanent AF might be superior to beta blocker therapy in regard to functional status and symptom burden. Given this diverging results we attempt to analysis a large cohort of patients facilitating a propensity score matching algorithm. Purpose To assess the associations of digitalis treatment with mortality in patients with increased cardiovascular risk. Methods Patients were derived from a large cohort study including participants from a tertiary care centre who were referred to coronary angiography. The propensity score matching is based on a predefined list of variables, with digitalis as treatment. Matching strategy is nearest neighbour matching and to prove consistency, radius matching (radius = 0.1). For survival analysis we used a Cox proportional hazard regression comparing patients with and without digitalis for all-cause mortality. The analysis is conducted using STATA 13 MP. All patients provided written informed consent and the study was approved by the ethics committee. Results A total of 2457 patients (median age: 63.5 [IQR = 56.3–70.6] years, 30.1% women) referred to coronary angiography, with a median follow up of 9.9 (IQR = 8.5–10.7) years were included. The matching process and the resulting propensity score fulfilled all statistical assumptions and resulted in a balanced cohort. The risk for all-cause mortality was higher among propensity score matched participants not treated with digitalis compared to patients on treatment (n=514) HR 3.03 (95% CI 2.5 to 3.7). Total mortality in patients with AF on digitalis after a median follow-up of 9.9 years was 27.6%. At baseline, only 42.4% of patients with AF were on oral anticoagulation. Conclusions In the present cohort treatment with digitalis was associated with a lower risk of all-cause mortality after long-term follow-up. The patient population has a clinically significant 10-year mortality risk. The results may not apply to other cohorts but may help inform future clinical trials. FUNDunding Acknowledgement Type of funding sources: None.


2019 ◽  
Vol 55 (3) ◽  
pp. 613-622 ◽  
Author(s):  
Anna Sureda ◽  
Christian Chabannon ◽  
Tamás Masszi ◽  
David Pohlreich ◽  
Christof Scheid ◽  
...  

Abstract Plerixafor + granulocyte-colony stimulating factor (G-CSF) is administered to patients with lymphoma who are poor mobilizers of hematopoietic stem cells (HSCs) in Europe. This international, multicenter, non-interventional registry study (NCT01362972) evaluated long-term follow-up of patients with lymphoma who received plerixafor for HSC mobilization versus other mobilization methods. Propensity score matching was conducted to balance baseline characteristics between comparison groups. The following mobilization regimens were compared: G-CSF + plerixafor (G + P) versus G-CSF alone; G + P versus G-CSF + chemotherapy (G + C); and G-CSF + plerixafor + chemotherapy (G + P + C) versus G + C. The primary outcomes were progression-free survival (PFS), overall survival (OS), and cumulative incidence of relapse (CIR). Overall, 313/3749 (8.3%) eligible patients were mobilized with plerixafor-containing regimens. After propensity score matching, 70 versus 36 patients were matched in the G + P versus G-CSF alone cohort, 124 versus 124 in the G + P versus G + C cohort, and 130 versus 130 in the G + P + C versus G + C cohort. For both PFS and OS, the upper bound of confidence interval for the hazard ratio was >1.3 for all comparisons, implying that non-inferiority was not demonstrated. No major differences in PFS, OS, and CIR were observed between the plerixafor and comparison groups.


EP Europace ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. 1526-1536
Author(s):  
Marie Decroocq ◽  
Louis Rousselet ◽  
Margaux Riant ◽  
Laurène Norberciak ◽  
Guillaume Viart ◽  
...  

Abstract Aims Pacemaker implantation (PI) after atrioventricular nodal re-entry tachycardia (AVNRT) ablation is a dreadful complication. We aimed to assess periprocedural, early, and late risks for PI. Methods and results All 27 022 patients who underwent latest AVNRT ablation in France from 2009 to 2017, were identified in the nationwide medicalization database. A control group of 305 152 patients hospitalized for arm, leg, or skin injuries with no history of AVNRT or supraventricular tachycardia were selected. After propensity score matching, both groups had mean age of 53 ± 18 years and were predominantly female (64%). During this 9-year period, 822 of 27 022 (3.0%) AVNRT patients underwent PI, with significant higher risk in propensity-matched AVNRT patients compared to propensity-matched controls [2.9% vs. 0.9%; hazard ratio 3.4 (2.9–3.9), P &lt; 0.0001]. This excess risk was significant during all follow-up, including periprocedural (1st month), early (1–6 months), and late (&gt;6 months) risk periods. Annualized late risk per 100 AVNRT patients was 0.2%. In comparison to controls, excess risk was 0.2% in &lt;30-year-old AVNRT patients; 0.7% in 30–50-year-old; 1.1% in 50–70-year-old and 6.5% over 70-year-olds. Risk for PI was also significantly different according to three procedural factors: centres, experience, and ablation date, with a 30% decrease since 2015. Conclusion Periprocedural, early, and late risks for PI were higher after AVNRT ablation compared to propensity-matched controls. Longer follow-up is needed as the excess risk seems to persist late after AVNRT ablation.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Dyrbus ◽  
M Gasior ◽  
P Desperak ◽  
J Nowak ◽  
T Osadnik ◽  
...  

Abstract Background Prevalence of familial hypercholesterolemia (FH) is high among patients with coronary artery disease (CAD). However, data on FH among patients with acute coronary syndrome (ACS) are still scarce. Purpose Therefore, we aimed to assess the prevalence, lipid-lowering therapy and short- and long-term outcomes in patients with FH among patients with ACS. Methods We finally included 19,582 consecutive patients from the Hyperlipidaemia Therapy in the tERtiary Cardiological cEnTer (TERCET) Registry for years 2006–2018. Among them, there were 7,319 patients admitted with ACS: 3,085 due to ST-segment elevation acute coronary syndrome (STEMI), 2,256 due to NSTEMI, and 1,978 due to unstable angina (UA). Stable CAD [sCAD] group n=12,462 that was treated as a reference one. Based on the personal and familial history of premature cardiovascular disease and low-density lipoprotein cholesterol (LDL-C) concentration, the Dutch Lipid Clinic Network (DLCN) algorithm was used for FH diagnosis. Results At the time of hospitalization, the overall occurrence of probable/definite FH and possible FH were 1.2% and 13.5% respectively. In patients with ACS, 1.6% had probable/definite FH and 17.0% possible FH. The highest occurrence of FH was observed in STEMI subgroup, where 20.6% of the patients had ≥3 points according to the DLCN criteria. There were significant differences in hypolipemic treatment between the FH subpopulations. In patients with definite/probable FH 92.3% and 91.5% were administered statins at discharge, respectively (including 52.9% prescribed intensive statin therapy). Patients with definite and probable FH had higher 30-day mortality than patients without FH (8.2% and 3.8% vs 2.0%, respectively; p=0.0052). However, no significant differences were observed between the FH groups in the 12-, 36- and 60-month follow-up (Figure). Propensity-score matching analysis showed that definite/probable FH patients had significantly higher all-cause mortality at the 36- and 60-month follow-up in comparison to non-FH subjects (11.4% vs 4.8% and 19.2% vs 7.2%, respectively; p≤0.021 for both). Outcomes depending on DCLN FH diagnosis. Conclusions The prevalence of FH according to the DLCN criteria in the Polish very high-risk population is even 14.7% and is significantly higher in patients with ACS than in patients with sCAD. Among patients included in the Registry, the occurrence of FH rises to 20.6% in the STEMI subgroup, and to 17.2% in the NSTEMI subgroup. Propensity-score matching analysis confirmed that FH itself is a cause of increased all-cause mortality in the long-term follow-up. Acknowledgement/Funding None


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Wei-Chieh Lee ◽  
Pai-Wei Lee ◽  
Po-Jui Wu ◽  
Yen-Nan Fang ◽  
Huang-Chung Chen ◽  
...  

Abstract Objective Long-term oral anticoagulant should be considered or recommended in patients with atrial fibrillation (AF) and CHA2DS2VASc score ≥ 1 for stroke prevention. Warfarin and different direct oral anticoagulants (DOACs) are metabolized differently by the kidney. The impact on renal function after long-term use of anticoagulants in the patients with AF remains unclear. This study aimed to compare DOACs and warfarin’s impact on the decline in renal function from a large cohort with AF. Methods This study included patients with nonvalvular AF from 2000 to 2018, mainly through the medical history (ICD code) of the Chang Gung Research Database. Baseline estimated glomerular filtration rate (eGFR), follow-up eGFR and the change in eGFR between 2-year eGFR and baseline eGFR were compared between different DOACs and warfarin after propensity score matching. The primary study endpoint was acute kidney injury (AKI). Results 3657 patients were enrolled in this study and the mean observation time was 3.3 ± 0.9 years. During the observation period, there was a significantly higher incidence of AKI during follow-up in the warfarin group than in the different DOAC groups before and after propensity score matching (before: warfarin vs. DOAC: 9.2% vs. 5.2%, p <  0.001; after: warfarin vs. DOAC: 8.9% vs. 4.4%, p <  0.001). There was no difference in the incidence of AKI between dabigatran group and anti-factor Xa inhibitor group after propensity score matching. The incidence of AKI was similar among rivaroxaban, apixaban and edoxaban groups after propensity score matching. The change in eGFR between 2-year eGFR and baseline eGFR did not differ between the warfarin and DOAC groups after propensity score matching (warfarin vs. DOAC: − 1.27 ± 20.32 vs. -1.94 ± 17.24 mL/min/1.73 m2, p = 0.461). Conclusions During the mean observation time of 3.3 ± 0.9 years, warfarin was associated with a higher incidence of AKI compared with DOACs. The decline in renal function did not differ among warfarin and different DOAC groups.


2013 ◽  
Author(s):  
Francesca Menegazzo ◽  
Melissa Rosa Rizzotto ◽  
Martina Bua ◽  
Luisa Pinello ◽  
Elisabetta Tono ◽  
...  

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 168-170
Author(s):  
K Elsolh ◽  
D Tham ◽  
M A Scaffidi ◽  
R Bansal ◽  
J Li ◽  
...  

Abstract Background Inflammatory Bowel Disease (IBD) studies have commonly relied on real-world evidence to evaluate different therapies. An emerging idea has been the use of propensity score matching as a statistical method to account for baseline characteristics in IBD patients. In retrospective studies, propensity score matching of patients helps reduce treatment assignment bias and mimic the effects of randomization. Recently, propensity-score matching has become an important tool in IBD studies comparing biologic therapeutics. Biologic medications are among the highest-grossing drugs worldwide, and their pharmaceutical producers make considerable payments to physicians to market them. In spite of this, there is a lack of evidence examining the role of undue industry influence among propensity-score matched comparative studies evaluating biologic therapeutics for IBD. Aims Given the documented association between IBD biologics and FCOI, we hypothesize a high burden of FCOI in propensity-score matched studies. The aim of this study was to evaluate the prevalence of disclosed & undisclosed financial conflicts of Interest (FCOI) in propensity-score matched comparison studies evaluating biologics for IBD. Methods We developed & ran a librarian-reviewed systematic search on EMBASE, MEDLINE, and Cochrane Library databases for all propensity-score matched retrospective studies comparing biologics for the treatment of IBD. Full-text retrieval & screening was performed on all studies in duplicate. 16 articles were identified. Industry payments to authors were only considered FCOI if they were made by a company producing a biologic that was included in the comparison study. Disclosed FCOI were identified by authors’ interests disclosures in full-texts. Any undisclosed FCOI among US authors were identified using the Centre for Medicare and Medicaid Services (CMS) Open Payments Database, which collects industry payments to physicians. Results Based on a preliminary analysis of 16 studies, there was at least one author with a relevant FCOI in 14 (88%) of the 16 studies. 14 studies (88%) had at least one disclosed FCOI, while 6 studies (37.5%) had at least one undisclosed FCOI. Among studies with disclosed FCOI, a mean of 40.2% (SD = 23.4%) of authors/study reported FCOI. Among studies with undisclosed FCOI, a mean of 18.8% (SD = 7.0%) of authors/study reported FCOI. The total dollar value of FCOIs was $1,974,328.3. The median conflict dollar value was $5,576.6 (IQR: $321.6 to $36,394.9). Conclusions We found a high burden of undisclosed FCOI (37.5%) among authors of propensity-score matched studies evaluating IBD biologics. Given the potential for undue industry influence stemming from such payments, authors should ensure better transparency with industry relationships. Funding Agencies None


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