Development Of An International Observational Study Programme To Describe The Management And Outcomes Of Mild Stroke And Transient Ischaemic Attack In Routine Clinical Practice

ObjectiveTo evaluate the influence of intracerebral haemorrhage (ICH) location on stroke outcomes.MethodsWe included patients recruited to a UK hospital-based, multicentre observational study of adults with imaging confirmed spontaneous ICH. The outcomes of interest were occurrence of a cerebral ischaemic event (either stroke or transient ischaemic attack) or a further ICH following study entry. Haematoma location was classified as lobar or non-lobar.ResultsAll 1094 patients recruited to the CROMIS-2 (Clinical Relevance of Microbleeds in Stroke) ICH study were included (mean age 73.3 years; 57.4% male). There were 45 recurrent ICH events (absolute event rate (AER) 1.88 per 100 patient-years); 35 in patients presenting with lobar ICH (n=447, AER 3.77 per 100 patient-years); and 9 in patients presenting with non-lobar ICH (n=580, AER 0.69 per 100 patient-years). Multivariable Cox regression found that lobar ICH was associated with ICH recurrence (HR 8.96, 95% CI 3.36 to 23.87, p<0.0001); similar results were found in multivariable completing risk analyses. There were 70 cerebral ischaemic events (AER 2.93 per 100 patient-years); 29 in patients presenting with lobar ICH (AER 3.12 per 100 patient-years); and 39 in patients with non-lobar ICH (AER 2.97 per 100 patient-years). Multivariable Cox regression found no association with ICH location (HR 1.13, 95% CI 0.66 to 1.92, p=0.659). Similar results were seen in completing risk analyses.ConclusionsIn ICH survivors, lobar ICH location was associated with a higher risk of recurrent ICH events than non-lobar ICH; ICH location did not influence risk of subsequent ischaemic events.Trial registration numberNCT02513316.

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A multicentre, UK, retrospective, observational study to assess the effectiveness of insulin glargine 300 units/ml in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA)

Diabetic Medicine ◽

10.1111/dme.13847 ◽

2018 ◽

Vol 36 (1) ◽

pp. 110-119 ◽

Cited By ~ 3

Author(s):

T. Pang ◽

S. C. Bain ◽

R. Neil A. Black ◽

J. G. Boyle ◽

J. Elliott ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 1 Diabetes ◽

Clinical Practice ◽

Observational Study ◽

Insulin Glargine ◽

Type 1 Diabetes Mellitus ◽

Routine Clinical Practice ◽

Retrospective Observational Study

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Transfusions prior to established kidney disease Fox KM, Yee J, Cong Z, Brooks JM, Petersen J, Lamerato L, Gandra SR (2012) Transfusion burden in non-dialysis chronic kidney disease patients with persistent anemia treated in routine clinical practice: a retrospective observational study. BMC Nephrol 13: 5

Journal of Renal Nursing ◽

10.12968/jorn.2012.4.2.105a ◽

2012 ◽

Vol 4 (2) ◽

pp. 105-105

Keyword(s):

Chronic Kidney Disease ◽

Clinical Practice ◽

Kidney Disease ◽

Observational Study ◽

Routine Clinical Practice ◽

Retrospective Observational Study

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Patient (pt) characteristics and treatment patterns in the radium (Ra)-223 REASSURE observational study.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.5042 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 5042-5042 ◽

Cited By ~ 1

Author(s):

Celestia S. Higano ◽

Shawn H. Zimberg ◽

Sabina Dizdarevic ◽

Lauren Christine Harshman ◽

John Logue ◽

...

Keyword(s):

Clinical Practice ◽

Observational Study ◽

Interim Analysis ◽

Routine Clinical Practice ◽

Castration Resistant Prostate Cancer ◽

Castration Resistant ◽

Observation Methods ◽

Short And Long Term ◽

Grade 3

5042 Background: Ra-223, a targeted alpha therapy, prolonged survival with good safety in metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 ALSYMPCA trial. REASSURE will evaluate Ra-223 short- and long-term safety in routine clinical practice settings. This is the first planned interim analysis (median 7 mo observation). Methods: This global, prospective, single-arm, observational study enrolled pts with mCRPC with bone metastases (mets) for whom Ra-223 therapy was planned. Follow-up will continue up to 7 years after last Ra-223 dose. Results: 1106 pts (437 N. America, 665 Europe, 4 not recorded) enrolled from 2 Sep 2014 to 22 Sep 2016. Baseline data are available from 583 pts receiving 1st- (1L), 2nd- (2L), or ≥3rd-line (≥3L) Ra-223 for mCRPC(Table). The majority of pts (n=369, 63%) completed 5–6 doses (1L, 70%; 2L, 64%; ≥3L, 49%); median 6 doses (1L,6; 2L, 6; ≥3L, 4). Treatment-emergent drug-related AEs occurred in 215 pts (37%). Post-treatment grade 3/4 thrombocytopenia occurred in 14 pts (2.4%) and anemia in 45 (7.7%). Conclusions: In routine clinical practice, Ra-223 was associated with no short-term safety concerns and appeared to be used in pts with less advanced mCRPC than in ALSYMPCA. The majority of pts on 1L/2L Ra-223 therapy received 5–6 doses. Ra-223 was often used with abiraterone or enzalutamide, but not chemotherapy. The next interim analysis in 2019 will report long-term safety and outcomes on all pts. Clinical trial information: NCT02141438. [Table: see text]

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Clinical outcomes and patient (pt) profiles in REASSURE: An observational study of radium-223 (Ra-223) in metastatic castration-resistant prostate cancer (mCRPC).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.6_suppl.32 ◽

2020 ◽

Vol 38 (6_suppl) ◽

pp. 32-32

Author(s):

Celestia S. Higano ◽

Fred Saad ◽

A. Oliver Sartor ◽

Kurt Miller ◽

Peter Conti ◽

...

Keyword(s):

Bone Marrow ◽

Clinical Practice ◽

Observational Study ◽

Clinical Outcomes ◽

Bone Fractures ◽

Bone Marrow Suppression ◽

Routine Clinical Practice ◽

Metastatic Sites

32 Background: Ra-223 is a targeted alpha therapy that showed a survival advantage and favorable safety profile in the phase 3 ALSYMPCA trial in pts with mCRPC. REASSURE (NCT02141438) is evaluating the long-term safety of Ra-223 in routine clinical practice in pts with mCRPC over a 7-year follow-up period. Methods: In this global, prospective, single-arm, observational study, the second prespecified interim analysis (data cut-off March 2019) evaluated safety and clinical outcomes of Ra-223 in pts with mCRPC. Primary outcome measures were incidence of second primary malignancies (SPM), bone marrow suppression and short- and long-term safety in pts who had ≥1 Ra-223 dose. Secondary outcomes included overall survival (OS). Results: For 1465 pts in the safety analysis, median follow up was 11.5 months. Median PSA (n=1053), ALP (n=1048), and LDH (n=555) levels at baseline were 59 ng/mL, 135 U/L, and 269 U/L, respectively. 81% of pts had bone metastases only at baseline; 19% of pts had other metastatic sites, mostly in the lymph nodes. 19% of pts had <6 metastatic sites, 47% had 6–20 sites, 20% had >20 lesions but not a superscan, and 6% had a superscan. 45%, 38%, 37%, 9%, and 8% of pts received prior abiraterone, docetaxel, enzalutamide, cabazitaxel, or sipuleucel-T as prior therapies, respectively. Median number of Ra-223 doses received was 6; 67% of pts had ≥5 doses. SPM occurred in 1% of pts. The most common treatment-emergent drug-related adverse event (AE) of any grade was diarrhea (11%). 10% of pts had a bone-associated event, 5% had fractures, and 15% had a hematological AE. Median OS was 15.6 months (95% CI 14.6–16.5). Conclusions: In REASSURE, there was a low incidence of SPM, bone fractures, and bone marrow suppression after Ra-223 treatment, with no new AEs identified. This study confirms that in routine clinical practice, Ra-223 AE rates were low, and pts generally received ≥5 doses. Clinical trial information: NCT02141438. [Table: see text]

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