scholarly journals Prostatic urethral lift (UroLift): a real-world analysis of outcomes using hospital episodes statistics

BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Toby Page ◽  
Rajan Veeratterapillay ◽  
Kim Keltie ◽  
Julie Burn ◽  
Andrew Sims
Keyword(s):  
Real World ◽  
Hazard Analysis ◽  
Attendance Rate ◽  
Day Case ◽  
Patient Demographics ◽  
Kaplan Meier ◽  
Accident And Emergency ◽  
Case Surgery ◽  
Observational Cohort ◽  
Rate Requirement

Abstract Background To determine real-world outcomes of prostatic urethral lift (UroLift) procedures conducted in hospitals across England. Methods A retrospective observational cohort was identified from Hospital Episode Statistics data including men undergoing UroLift in hospitals in England between 2017 and 2020. Procedure uptake, patient demographics, inpatient complications, 30-day accident and emergency re-attendance rate, requirement for further treatment and catheterization were captured. Kaplan–Meier and hazard analysis were used to analyse time to re-treatment. Results 2942 index UroLift procedures from 80 hospital trusts were analysed; 85.3% conducted as day-case surgery (admitted to hospital for a planned surgical procedure and returning home on the same day). In-hospital complication rate was 3.4%. 93% of men were catheter-free at 30 days. The acute accident and emergency attendance rate within 30 days was 12.0%. Results of Kaplan Meier analysis for subsequent re-treatment (including additional UroLift and endoscopic intervention) at 1 and 2 years were 5.2% [95% CI 4.2 to 6.1] and 11.9% [10.1 to 13.6] respectively. Conclusions This real-world analysis of UroLift shows that it can be delivered safely in a day-case setting with minimal morbidity. However, hospital resource usage for catheterization and emergency hospital attendance in the first 30 days was substantial, and 12% required re-treatment at 2 years.

Patterns of hedgehog inhibitor (HHI) treatment interruptions and re-initiations among patients with basal cell carcinoma (BCC) in real-world clinical practice.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19349-e19349
Author(s):  
Jessica J. Jalbert ◽  
Chieh-I Chen ◽  
Ning Wu ◽  
Matthew G. Fury ◽  
Emily S Ruiz ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Treatment Duration ◽  
Index Date ◽  
Sensitivity Analyses ◽  
Kaplan Meier ◽  
Treatment Interruptions ◽  
Observational Cohort ◽  
Practice Methods

e19349 Background: HHIs are oral targeted therapies approved for the treatment of advanced BCC but treatment-related adverse events may result in treatment interruptions or discontinuation. The objective of this study was to describe HHI treatment patterns among patients with BCC in real-world clinical practice. Methods: We conducted an observational cohort study using MarketScan Commercial/Medicare databases (01/01/2013–09/30/2018). We identified new users of HHIs (index date = date of the first dispensation), ≥18 years of age who were continuously enrolled for ≥6 months prior to the index date (i.e. baseline) with ≥1 baseline BCC diagnosis. Treatment interruptions (TI) were defined as a lack of dispensation following the exhaustion of days’ supply and allotted grace period (GP). Re-initiation (RI) was defined as ≥1 HHI dispensation after TI. The Kaplan–Meier method was used to estimate risk and time to TI and, among patients with a TI, incidence of RI. HHIs are generally dispensed in 30-days’ supply and indicated as long as a patient derives a clinical benefit; however, since TIs are commonly employed during HHI therapy, sensitivity analyses were conducted using GPs of 14, 30, 60, 90, and 120 days. Results: We identified 469 patients with a BCC diagnosis initiating HHIs. The mean (SD) age was 67.6 (15.8) years, 64.2% were men, 51.2% were covered by commercial insurance, and 99.2% initiated vismodegib. Using a GP of 14, 30, 60, 90, and 120 days, the risk of TI was 79.2%, 68.8%, 60.0%, 55.4%, and 51.4% at 6 months and 94.8%, 91.3%, 88.2%, 83.2%, and 80.2% at 1 year, respectively. Median HHI treatment duration ranged from 94 days (95% CI: 90–109) using a GP of 14 days to 173 days (95% CI: 156–194) using a GP of 120 days. At 6 months following TI, incidence of RI was 35.8%, 19.8%, 11.3%, 6.9%, and 4.9% using a GP of 14, 30, 60, 90, and 120 days, respectively. The incidence of HHI RI at 1-year following TI ranged from 40.8% using a 14-day GP to 13.4% using a 120-day GP. Conclusions: Median HHI treatment duration was approximately 6 months, even after allowing for a 120-day GP. Median treatment duration was considerably shorter than what has been reported in clinical trials. Our results suggest that long-term HHI therapy may be difficult in a real-world setting.

Treatment outcomes with first-line (1L) nab-Paclitaxel + gemcitabine (AG) and FOLFIRINOX (FFX) in metastatic pancreatic adenocarcinoma (mPAC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18147-e18147 ◽  
Author(s):  
Thomas H. Cartwright ◽  
Monika Parisi ◽  
Janet L. Espirito ◽  
Thomas Wilson ◽  
Corey Pelletier ◽  
...  
Keyword(s):  
Real World ◽  
Performance Status ◽  
Stage Iv ◽  
Categorical Variables ◽  
Eligibility Criteria ◽  
Kaplan Meier ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Chi Squared ◽  
Observational Cohort ◽  
Ecog Ps

e18147 Background: AG and FFX have demonstrated improved overall survival (OS) compared to gemcitabine (GEM) as 1L treatment (tx) for mPAC. Limited comparative data exists on AG vs FFX. This study compared time to treatment failure (TTF), OS, and patient (pt) demographics in mPAC pts receiving 1L AG vs FFX, and evaluated outcomes by performance status (PS) in a real-world setting. Methods: This was a retrospective observational cohort study of adult pts diagnosed with stage IV mPAC treated with 1L AG, FFX, or GEM monotherapy between 04/2013 and 10/2015 with at least 3 mo follow-up, to 01/2016. We report results for AG vs FFX; AG vs GEM analysis is ongoing. Data were programmatically extracted from the iKnowMed electronic health record database of pts in The US Oncology Network. Eligibility included ≥3 doses of A (for AG) or ≥2 doses of fluorouracil (for FFX), and excluded pts on clinical trial or with other cancer diagnoses during the study period. Categorical variables were compared with chi-squared tests. TTF and OS were assessed using the Kaplan-Meier method. Results: 2,901 pts with mPAC receiving chemotherapy during the study period were initially identified. 486 total pts met all eligibility criteria, with 255 AG and 159 FFX pts. Median age was 68 and 61 yrs for AG and FFX respectively (p < .0001). ECOG PS was 0-1 in 77% of AG pts and 91% of FFX pts (p = 0.0004). Median TTF and mOS in all pts was 3.5 [95% CI 3.0-3.9] and 9.8 mo [95% CI 8.2-11.5] respectively. There was no statistical difference in mTTF or mOS for the AG vs FFX cohorts (mTTF 3.7 vs 4.3 mo, log-rank p = 0.25; and mOS 9.8 vs 11.4 mo, log-rank p = 0.38). Among pts with ECOG PS 0-1, TTF for AG vs FFX was 4.2 vs 4.3 mo respectively (log-rank p = 0.47); and OS for AG vs FFX was 12.1 vs 11.4 mo (log-rank p = 0.68). Conclusions: Although pts in the AG cohort were older and had worse PS, mTTF and mOS were not statistically different from pts in FFX. Results were similar after stratifying by PS. Limitations include the retrospective and non-randomized nature of the study. However, this represents real world outcomes where randomized data do not exist. Analysis of toxicities and resource utilization is ongoing and will aid in optimizing tx selection in these pts.

scholarly journals Real-world insight into public access defibrillator use over five years

Open Heart ◽  
2020 ◽  
Vol 7 (1) ◽  
pp. e001251 ◽  
Author(s):  
Hannah Torney ◽  
Olibhéar McAlister ◽  
Adam Harvey ◽  
Amy Kernaghan ◽  
Rebecca Funston ◽  
...  
Keyword(s):  
Real World ◽  
Response Times ◽  
Public Access ◽  
Case Report Form ◽  
Public Places ◽  
Patient Demographics ◽  
Life Saving ◽  
Medical Facilities ◽  
Observational Cohort ◽  
The Mean

BackgroundPublic access defibrillators (PADs) represent unique life-saving medical devices as they may be used by untrained lay rescuers. Collecting representative clinical data on these devices can be challenging. Here, we present results from a retrospective observational cohort study, describing real-world PAD utilisation over a 5-year period.MethodsData were collected between October 2012 and October 2017. Responders voluntarily submitted electronic data downloaded from HeartSine PADs, and patient demographics and other details using a case report form in exchange for a replacement battery and electrode pack.ResultsData were collected for 977 patients (692 males, 70.8%; 255 females, 26.1%; 30 unknown, 3.1%). The mean age (SD) was 59 (18) years (range <1 year to 101 years). PAD usage occurred most commonly in homes (n=328, 33.6%), followed by public places (n=307, 31.4%) and medical facilities (n=128, 13.1%). Location was unknown in 40 (4.09%) events. Shocks were delivered to 354 patients. First shock success was 312 of 350 patients where it could be determined (89.1%, 95% CI 85.4% to 92.2%). Patients with reported response times ≤5 min were more likely to survive to hospital admission (89/296 (30.1%) vs 40/250 (16.0%), p<0.001). Response time was unknown for 431 events.ConclusionThis is the first study to report global PAD usage in voluntarily submitted, unselected real-world cases and demonstrates the real-world effectiveness of PADs, as confirmed by first shock success.

scholarly journals P0741CHRONIC KIDNEY DISEASE PROGRESSION IN A LARGE PREVENTION COHORT IN COLOMBIA

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Angela Rivera ◽  
Angelito Bernardo ◽  
Jasmin Vesga ◽  
Izcay Ronderos ◽  
Mauricio Sanabria
Keyword(s):  
Kidney Disease ◽  
Disease Progression ◽  
Prevention Program ◽  
Reduction Rate ◽  
Progression Rate ◽  
Ckd Progression ◽  
Care Services ◽  
Kaplan Meier ◽  
Observational Cohort ◽  
Kidney Disease Progression

Abstract Background and Aims Chronic kidney disease (CKD) is a syndrome that today has important implications for the health of populations and the economic sustainability of health systems around the world, therefore strategies to slow disease progression are necessary. Aims: To estimate the incidence of renal replacement therapy (RRT) in a cohort of patients included in a CKD secondary prevention program and to describe the decrease of the estimated glomerular filtration rate (eGFR). Method This is a historical, multicenter, observational cohort study in a prevention program between January 1, 2010, and December 31, 2017, with follow-up until December 31, 2018, at the Renal Care Services (RCS) network. Socio-demographic and clinical characteristics of all patients were summarized descriptively. We estimated the incidence of RRT rate with Kaplan Meier analysis. Progression rate to RRT was analyzed by mixed-effects model adjusted for the eGFR reduction rate at 180 days; the model considered the diagnosis of diabetes. Results 7131 patients met the inclusion criteria for data analysis. The mean age was 65 years, 50.5% were female, (Table 1). There were 577 events of RRT with a rate of 2.02 events of RRT per 100 patients-year [95% CI,1.86 to 2.19], characteristics at the RRT initiation are presented in Table 2. At the beginning of the program the eGFR was 45.3 ml / min / 1.73m2 in non-diabetics, and 40.9 3 ml / min / 1.73m2 in diabetics. The CKD progression was - 0.48 ml / min / 1.73m2 per 180 days in diabetics and - 0.20 ml / min / 1.73m2 per 180 days in non-diabetics. The final events of the cohort are presented in Figure 1; the mortality rate was 0.89 events per 100 patients-year [95% CI, 0,79 to 1,01]. Conclusion This population of patients in a CKD prevention program presented a low rate of initiation of dialysis therapy and a slight decrease of eGFR; the diabetic status influences the CKD progression.

scholarly journals Comparison of Propofol and Thiopentone Anaesthesia (with Special Reference to Recovery Characteristics)

1987 ◽  
Vol 15 (4) ◽  
pp. 389-393 ◽  
Author(s):  
W. M. Weightman ◽  
M. Zacharias
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Day Case ◽  
Early Recovery ◽  
Day Case Surgery ◽  
Pain On Injection ◽  
High Incidence ◽  
Case Surgery ◽  
Repeated Doses ◽  
The Mean

Thiopentone and propofol were used for the induction and maintenance of anaesthesia in unpremedicated patients undergoing minor gynaecological procedures. There were no significant differences in the induction and maintenance characteristics except for a high incidence of pain on injection and a greater fall in the mean systolic blood pressure associated with propofol in comparison with thiopentone. Propofol was associated with a quicker early recovery as well as a faster psychomotor recovery, as tested by a peg-board. However, complete psychomotor recovery was not achieved for up to three hours in some patients receiving propofol and so caution is advised regarding the early street fitness of patients receiving repeated doses of the drug for day case surgery.

scholarly journals One-year outcomes of drug-coated balloon treatment for long femoropopliteal lesions: a multicentre cohort and real-world study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xiaoxi Yu ◽  
Xin Zhang ◽  
Zhichao Lai ◽  
Jiang Shao ◽  
Rong Zeng ◽  
...  
Keyword(s):  
Real World ◽  
Cox Regression ◽  
Ankle Brachial Index ◽  
Primary Patency ◽  
Critical Limb Ischaemia ◽  
Limb Ischaemia ◽  
Cox Regression Analysis ◽  
Femoropopliteal Artery ◽  
Kaplan Meier ◽  
Multicentre Cohort

Abstract Background Drug-coated balloons (DCBs) have shown superiority in the endovascular treatment of short femoropopliteal artery disease. Few studies have focused on outcomes in long lesions. This study aimed to evaluate the safety and effectiveness of Orchid® DCBs in long lesions over 1 year of follow-up. Methods This study is a multicentre cohort and real-world study. The patients had lesions longer than or equal to 150 mm of the femoropopliteal artery and were revascularized with DCBs. The primary endpoints were primary patency, freedom from clinically driven target lesion revascularization (TLR) at 12 months and major adverse events (all-cause death and major target limb amputation). The secondary endpoints were the changes in Rutherford classification and the ankle brachial index (ABI). Results One hundred fifteen lesions in 109 patients (mean age 67 ± 11 years, male proportion 71.6%) were included in this study. The mean lesion length was 252.3 ± 55.4 mm, and 78.3% of the lesions were chronic total occlusion (CTO). Primary patency by Kaplan–Meier estimation was 98.1% at 6 months and 82.1% at 12 months. The rate of freedom from TLR by Kaplan–Meier estimation was 88.4% through 12 months. There were no procedure- or device-related deaths through 12 months. The rate of all-cause death was 2.8%. Cox regression analysis suggested that renal failure and critical limb ischaemia (CLI) were statistically significant predictors of the primary patency endpoint. Conclusion In our real-world study, DCBs were safe and effective when used in long femoropopliteal lesions, and the primary patency rate at 12 months by Kaplan–Meier estimation was 82.1%.

Real-world treatment patterns in relapsed/refractory multiple myeloma: Clinical and economic outcomes in patients treated with pomalidomide or daratumumab

2021 ◽  
pp. 107815522199553
Author(s):  
Joshua Richter ◽  
Vamshi Ruthwik Anupindi ◽  
Jason Yeaw ◽  
Suneel Kudaravalli ◽  
Stojan Zavisic ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Treatment Options ◽  
Proteasome Inhibitors ◽  
Economic Outcomes ◽  
Office Visits ◽  
Refractory Multiple Myeloma ◽  
Kaplan Meier ◽  
Real World Evidence ◽  
New Treatment

Introduction Real-world evidence on later line treatment of relapsed/refractory multiple myeloma (RRMM) is sparse. We evaluated clinical outcomes among RRMM patients in the 1-year following treatment with pomalidomide or daratumumab and compared economic outcomes between RRMM patients and non-MM patients. Patient and Methods Adult patients with ≥1 claim of pomalidomide or daratumumab were identified between January 2012 and February 2018 using IQVIA PharMetrics® Plus US claims database. Patients were required to have a diagnosis or treatment for MM and a claim of any immunomodulatory drugs and proteasome inhibitors before the index date. Mean time to new therapy, overall survival (OS) using Kaplan-Meier curve and adverse events (AEs) were reported over the 1-year post-index period. RRMM patients were also matched to a non-MM comparator cohort and economic outcomes were compared between the two cohorts. Results 289 RRMM patients were matched to 1,445 patients without MM. Most prevalent hematological AE was anemia (72.0%) and non-hematological AE was infections (75.4%). Mean (SD) time to a new treatment was 4.7 (5.3) months and median OS was 14.6 months. RRMM patients had significantly higher hospitalizations and physician office visits (Both P < .0001) compared to non-MM patients. Adjusting for baseline characteristics, patients with RRMM had 4.9 times (95% CI 3.8-6.4, P < .0001) the total healthcare costs compared with patients without MM. The major driver of total costs among RRMM patients was pharmacy costs (67.3%). Conclusion RRMM patients showed a high frequency of AEs, low OS, and a substantial economic burden suggesting need for effective treatment options.

scholarly journals Real-World Palbociclib Use in HR+/HER2− Advanced Breast Cancer in Canada: The IRIS Study

2021 ◽  
Vol 28 (1) ◽  
pp. 678-688
Author(s):  
Katie Mycock ◽  
Lin Zhan ◽  
Gavin Taylor-Stokes ◽  
Gary Milligan ◽  
Debanjali Mitra
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Medical Records ◽  
Survival Rates ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Retrospective Chart Review ◽  
Hormone Receptor Positive ◽  
Kaplan Meier ◽  
Epidermal Growth

Background: Palbociclib is a selective cyclin-dependent kinase (CDK) 4/6 inhibitor used in combination with aromatase inhibitors or fulvestrant for patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2)-negative advanced/metastatic breast cancer (ABC/MBC). Palbociclib was the first CDK 4/6 inhibitor approved for HR+/HER2− ABC/MBC treatment in Canada in combination with letrozole (P+L) as an initial endocrine-based therapy (approved March 2016), or with fulvestrant (P+F) following disease progression after prior endocrine therapy (approved May 2017). The Ibrance Real World Insights (IRIS) study (NCT03159195) collected real-world outcomes data for palbociclib-treated patients in several countries, including Canada. Methods: This retrospective chart review included women with HR+/HER2− ABC/MBC receiving P+L or P+F in Canada. Physicians reviewed medical records for up to 14 patients, abstracting demographic and clinical characteristics, treatment patterns, and clinical outcomes. Progression-free rates (PFRs) and survival rates (SRs) at 6, 12, 18, and 24 months were estimated via Kaplan–Meier analysis. Results: Thirty-three physicians examined medical records for 247 patients (P+L, n = 214; P+F, n = 33). Median follow-up was 8.8 months for P+L and 7.0 months for P+F. Most patients were initiated on palbociclib 125 mg/d (P+L, 90.2%; P+F, 84.8%). Doses were reduced in 16.6% of P+L and 14.3% of P+F patients initiating palbociclib at 125 mg/d. The PFR for P+L was 90.3% at 12 months and 78.2% at 18 months; corresponding SRs were 95.6% and 93.0%. For P+F, 6-month PFR was 91.0%; 12-month SR was 100.0%. Conclusions: Dose reduction rates were low and PFR and SR were high in this Canadian real-world assessment of P+L and P+F treatments, suggesting that palbociclib combinations are well tolerated and effective.

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