Real‐world prevalence of the inclusion criteria for the LEADER trial: Data from a national general practice network

AimTo assess the impact of deprivation on diabetic retinopathy presentation and related treatment interventions, as observed within the UK hospital eye service.MethodsThis is a multicentre, national diabetic retinopathy database study with anonymised data extraction across 22 centres from an electronic medical record system. The following were the inclusion criteria: all patients with diabetes and a recorded, structured diabetic retinopathy grade. The minimum data set included, for baseline, age and Index of Multiple Deprivation, based on residential postcode; and for all time points, visual acuity, ETDRS grading of retinopathy and maculopathy, and interventions (laser, intravitreal therapies and surgery). The main outcome measures were (1) visual acuity and binocular visual state, and (2) presence of sight-threatening complications and need for early treatment.Results79 775 patients met the inclusion criteria. Deprivation was associated with later presentation in patients with diabetic eye disease: the OR of being sight-impaired at entry into the hospital eye service (defined as 6/18 to better than 3/60 in the better seeing eye) was 1.29 (95% CI 1.20 to 1.39) for the most deprived decile vs 0.77 (95% CI 0.70 to 0.86) for the least deprived decile; the OR for being severely sight-impaired (3/60 or worse in the better seeing eye) was 1.17 (95% CI 0.90 to 1.55) for the most deprived decile vs 0.88 (95% CI 0.61 to 1.27) for the least deprived decile (reference=fifth decile in all cases). There is also variation in sight-threatening complications at presentation and treatment undertaken: the least deprived deciles had lower chance of having a tractional retinal detachment (OR=0.48 and 0.58 for deciles 9 and 10, 95% CI 0.24 to 0.90 and 0.29 to 1.09, respectively); in terms of accessing treatment, the rate of having a vitrectomy was lowest in the most deprived cohort (OR=0.34, 95% CI 0.19 to 0.58).ConclusionsThis large real-world study suggests that first presentation at a hospital eye clinic with visual loss or sight-threatening diabetic eye disease is associated with deprivation. These initial hospital visits represent the first opportunities to receive treatment and to formally engage with support services. Such patients are more likely to be sight-impaired or severely sight-impaired at presentation, and may need additional resources to engage with the hospital eye services over complex treatment schedules.

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Generalizability of Trial Data to Real-World Practice: An Analysis of The Society of Thoracic Surgeons Intermacs Database

The Annals of Thoracic Surgery ◽

10.1016/j.athoracsur.2021.08.062 ◽

2021 ◽

Author(s):

Alexander A. Brescia ◽

Tessa M.F. Watt ◽

Francis D. Pagani ◽

Thomas M. Cascino ◽

Min Zhang ◽

...

Keyword(s):

Real World ◽

Trial Data

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Abstract 16784: Under-Enrollment of Real-World Heart Failure With Preserved Ejection Fraction Patients in Major HFpEF Clinical Trials

Circulation ◽

10.1161/circ.142.suppl_3.16784 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Joban Vaishnav ◽

Lisa R Yanek ◽

Virginia S Hahn ◽

Eunice Yang ◽

Rishi Trivedi ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Outcomes ◽

Real World ◽

Loop Diuretic ◽

Nyha Class ◽

Clinic Visit ◽

Inclusion Criteria ◽

Pulmonary Capillary ◽

Number Of Patients ◽

Wedge Pressure

Introduction: Inclusion criteria for enrollment in HFpEF clinical trials vary considerably and often exclude patients with co-morbidities such as obesity. We tested the hypotheses that: 1) a large number of patients with clinical and hemodynamic evidence of HFpEF are excluded from major HFpEF clinical trials; and 2) there is no difference in clinical outcomes between patients excluded versus those who met enrollment criteria by evaluating reasons for exclusion from HFpEF clinical trials and comparing clinical outcomes in a real-world HFpEF cohort. Methods: Patients referred to the Johns Hopkins HFpEF Clinic with clinical and hemodynamic evidence of HFpEF (pulmonary capillary wedge pressure [PCWP] ≥ 12 mmHg on a loop diuretic or PCWP ≥ 15 mmHg) were assessed for inclusion into 4 major HFpEF trials (TOPCAT, I-PRESERVE, PARAGON-HF, and RELAX). Cumulative hazard of HF hospitalization or death at 2 years from index clinic visit was compared between patients included and excluded by each trial. Results: Of 132 HFpEF patients, the median PCWP was 19 mmHg (IQR: 15-22 mmHg). Forty-four (33%) of patients met enrollment criteria for TOPCAT, 39 (29%) for I-PRESERVE, 21 (16%) for PARAGON-HF, and 50 (38%) for RELAX. The top 5 criteria that would have excluded patients included low natriuretic peptide level, obesity, elevated blood pressure, young age, and low hemoglobin (Figure 1A) . There was no difference in HF burden (hospitalizations, diuretic dosing, or NYHA class), or in clinical outcomes including HF hospitalization or death between patients who did or did not meet inclusion criteria for each clinical trial (Figure 1B ). Conclusion: We demonstrate that in a real-world cohort of hemodynamically-proven HFpEF few patients would have met criteria for enrollment in major HFpEF clinical trials, yet HF burden and outcomes were no different. Given the lack of proven therapies in HFpEF, consideration should be given to unifying and broadening enrollment criteria in HFpEF clinical trials.

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Abstract 15829: Temporal Characteristics of Intra-thoracic Impedance Before and After Heart Failure Hospitalizations in a Large Real-world Population of Patients With Cardiovascular Implanted Electronic Devices

Circulation ◽

10.1161/circ.142.suppl_3.15829 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Shantanu Sarkar ◽

Jodi L Koehler ◽

Eddy Warman

Keyword(s):

Real World ◽

Electronic Devices ◽

Primary Diagnosis ◽

Implantable Devices ◽

World Population ◽

Inclusion Criteria ◽

Temporal Characteristics ◽

Before And After ◽

Intrathoracic Impedance

Introduction: Intrathoracic impedance (IMP), measured in ICD/CRTD implantable devices, is a measure of intravascular blood volume and have been shown to correlate with intracardiac pressures. We investigated the temporal characteristics of IMP before and after HF events (HFE) in a large real-world cohort of patients (pts) with ICD/CRTD devices. Methods: We linked Optum© deidentified EHR dataset during the period from 2007-2017 to the Medtronic CareLink data warehouse. Pts with ICD/CRTD implants with IMP measurements were included. HFE was defined as an inpatient, ED, or observation unit stay with primary diagnosis of HF and IV diuretics administration. Temporal average of IMP measurement across all pts in the 60 days pre and post HFE were compared for HFE with and without readmission for HF within 60 days and in pts with no HFE. Results: A total of 17,886 pts with 1.8±1.2 years of follow-up met inclusion criteria. The average age was 66.6 ±12.3 years, with 72% being males, and 51% with ICD devices. A total of 1174 pts had 1425 HFE with no readmission and 282 pts had 295 HFE which were followed by readmission. A total of 17,839 pts had no HFE over 86,858 follow-up months. The average IMP during HFE, with and without readmission, and in pts with no HFE are shown in Fig. IMP decreases over a period of time prior to HFE and recovers due to treatment during HFE. The average IMP across all patients was lower on all 60 days pre and post HFE with readmission compared to HFE with no readmission (p<0.001) and both were lower compared to follow-up period with no HFE (p<0.001). The IMP recovers less often after HF events which are followed by readmission within 60 days compared to HF events with no readmission. Conclusions: In a large real-world population of pts with ICD/CRTD devices, on an average IMP reduces prior to and recovers during HFE. IMP was lower before and after HFE with readmission compared to HFE with no readmission. Readmission is more likely in pts with smaller impedance recovery after HF events.

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Use of Augmented Reality in Reconstructive Microsurgery: A Systematic Review and Development of the Augmented Reality Microsurgery Score

Journal of Reconstructive Microsurgery ◽

10.1055/s-0039-3401832 ◽

2019 ◽

Vol 36 (04) ◽

pp. 261-270

Author(s):

Yasser Al Omran ◽

Ali Abdall-Razak ◽

Catrin Sohrabi ◽

Tiffanie-Marie Borg ◽

Hayat Nadama ◽

...

Keyword(s):

Systematic Review ◽

Augmented Reality ◽

Systematic Reviews ◽

Real World ◽

Digital Information ◽

Inclusion Criteria ◽

Qualitative Synthesis ◽

Reconstructive Microsurgery ◽

User Access ◽

Meta Analyses

Abstract Background Augmented reality (AR) uses a set of technologies that overlays digital information into the real world, giving the user access to both digital and real-world environments in congruity. AR may be specifically fruitful in reconstructive microsurgery due to the dynamic nature of surgeries performed and the small structures encountered in these operations. The aim of this study was to conduct a high-quality preferred reporting items for systematic reviews and meta-analyses (PRISMA) and assessment of multiple systematic reviews 2 (AMSTAR 2) compliant systematic review evaluating the use of AR in reconstructive microsurgery. Methods A systematic literature search of Medline, EMBASE, and Web of Science databases was performed using appropriate search terms to identify all applications of AR in reconstructive microsurgery from inception to December 2018. Articles that did not meet the objectives of the study were excluded. A qualitative synthesis was performed of those articles that met the inclusion criteria. Results A total of 686 articles were identified from title and abstract review. Five studies met the inclusion criteria. Three of the studies used head-mounted displays, one study used a display monitor, and one study demonstrated AR using spatial navigation technology. The augmented reality microsurgery score was developed and applied to each of the AR technologies and scores ranged from 8 to 12. Conclusion Although higher quality studies reviewing the use of AR in reconstructive microsurgery is needed, the feasibility of AR in reconstructive microsurgery has been demonstrated across different subspecialties of plastic surgery. AR applications, that are reproducible, user-friendly, and have clear benefit to the surgeon and patient, have the greatest potential utility. Further research is required to validate its use and overcome the barriers to its implementation.

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P0816CLINICAL CHARACTERISTICS AND EGFR AND UACR DISTRIBUTION ACCORDING TO THE 2012 KDIGO CKD CLASSIFICATION: A REPORT FROM THE US DISCOVER CKD COHORT

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa142.p0816 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

Juan Jose Garcia Sanchez ◽

Juan Jesus Carrero ◽

Supriya Kumar ◽

Roberto Pecoits-Filho ◽

Glen James ◽

...

Keyword(s):

Kidney Disease ◽

Real World ◽

Patient Characteristics ◽

Study Cohort ◽

Diagnostic Code ◽

Inclusion Criteria ◽

Real World Data ◽

Electronic Health Record Data ◽

World Data ◽

Co Morbidity

Abstract Background and Aims In 2012, the Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommended categorising and prognosticating chronic kidney disease (CKD) based on estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR). Contemporary studies describing the prevalence and characteristics of patients with CKD categorised according KDIGO 2012 and how studies of new pharmacotherapies relate to these categories are scarce. One such new therapy class of key interest are the sodium glucose co-transporter 2 inhibitors (SGLT-2i), shown to delay the progression to renal failure and prevent cardiovascular/renal death in patients with CKD. We aimed to describe patient characteristics and the prevalence of CKD according to the 2012 KDIGO categories in a large real-world US cohort of patients with CKD (part A). We also describe a subset of the population according to the DAPA-CKD trial inclusion criteria (eGFR [25-75ml/min/1.73m2] and UACR [200-5000mg/g]) (part B). Method DISCOVER-CKD is an international observational study in patients with CKD. The DISCOVER-CKD retrospective US cohort of patients was extracted using real-world data from the integrated Limited Claims and Electronic Health Record data (IBM Health, Armonk, NY) and HealthVerity. Patients were aged ≥18 years, with ≥1 UACR measure. For part A, required first diagnostic code of CKD (Stages 3A, 3B, 4, 5, or ESRD) or two eGFR of <75 mL/min/1.73 m2 recorded at least 90 days apart and for part B, two measures of eGFR 25-75 mL/min/1.73 m2 recorded at least 90 days apart between 1st January 2008 and September 2018. Index date was diagnostic code or 2nd eGFR. The first UACR, recorded +/-12 months of index, was used to categorise patients. Descriptive analyses were used to summarise prevalence and patient characteristics. Results Of the overall study cohort (N=4330, 49.1% women, mean age 65.3±10.64 years), by KDIGO categories (part A): 85.7% (n=3601) had normal to mildly increased albuminuria, 11.0% (n=463) had moderately increased albuminuria and 3.3% (n=137) had severely increased albuminuria (Figure 1). 4.6% (n=193) fulfilled DAPA-CKD trial inclusion criteria (part B). In both populations, the most common comorbidities were hypertension (HTN, 73.0% for both) and type 2 diabetes (T2D, 57.6% and 56.2%, respectively). Anti-hypertensive drugs were frequently used (76.4% and 76.9%, respectively). Conclusion This study, utilising real-world data, adds to the scarcity of knowledge reporting the characteristics of patients with CKD in different eGFR and UACR strata according to the KDIGO 2012 definitions. We observed a trend in higher UACR in the group of patients with lower eGFR and report a high prevalence of T2D and HTN in the study population, demonstrating the high co-morbidity burden in patients, for whom new therapies may be beneficial.

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P647An audit of possible familial hypercholesterolaemia in general practice

European Heart Journal ◽

10.1093/eurheartj/ehz747.0254 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

J Gallagher ◽

M McGuckin ◽

D Behan ◽

P Harrington

Keyword(s):

Cardiovascular Disease ◽

General Practice ◽

Familial Hypercholesterolaemia ◽

Lipid Lowering ◽

Inclusion Criteria ◽

Clinical Notes ◽

Structured Care ◽

Premature Cardiovascular Disease ◽

History Of ◽

The Mean

Abstract Background Familial hypercholesterolaemia (FH) is an autosomal dominant condition associated with elevated total cholesterol and low-density lipoprotein (LDL). It confers an increased risk of premature cardiovascular disease and associated mortality. It is estimated that the majority of patients with FH in Ireland are undiagnosed and structured care programmes are not available. Purpose To undertake an audit of those patients in a general practice with possible FH Methods A retrospective audit was carried out on the patients attending a GP practice. Inclusion criteria for the study were as follows: LDL level >4.9mmol/L Triglyceride level (<2mmol/L) Data was collected from the patients' clinical notes and patients were interviewed to acquire additional details not available in the clinical notes where possible. A Dutch Lipid Clinic Network Score (DLCNS) was calculated for each patient. Results Of 5,438 patients with a LDL recorded 284 patients fulfilled the inclusion criteria. 52.4% were female. Mean age 60 years old (range: 19–95 years). The highest LDL level recorded for these patients ranged from 5.0 - 8.6 mmol/L, with a mean value of 5.4 mmol/L. The mean most recent LDL level was 3.6mmol/L (range: 1.0–6.3 mmol/L). 42 patients (14.8%) had a family history of premature coronary and/or vascular disease in line with DLCNS criteria. 9 patients (3.2%) had a personal history of premature cardiovascular disease. The DLCNS was calculated for each patient based on the information available. 225 patients (79.2%) had a score of 3, 36 patients (12.7%) had a score of 4, 12 patients (4.2%) had a score of 5 and 6 patients (2.1%) had a score of 6. This equates to 273 patients (96.1%) with a possible diagnosis of FH, and 6 patients (2.1%) with a probable diagnosis of FH. The mean most recent systolic blood pressure reading for these patients was 128mmHg, and diastolic 76mmHg. 51 patients (18%) were current smokers, 83 (29.2%) were ex-smokers, and 111 (39%) had never smoked. Smoking status was unknown for 38 patients (13.4). 128 patients (45%) were on lipid-lowering treatment at the time of this audit. 60 (21.1%) were on high intensity treatment, 68 (23.9%) were on medium intensity treatment and none were on low intensity treatment. 24.3% of patients were at target LDL. There were 5 patients (1.8%) currently receiving ezetimibe and 1 (0.4%) on fenofibrate. Conclusion A significant number of patients had a LDL >5mmol/l in this audit. Only 45% were on lipid lowering treatment and 24.3% were at a target LDL. This highlights the needs for structured programmes for screening and management of FH in primary care. Acknowledgement/Funding Funded by an unrestricted grant from Amgen

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The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

Health and Quality of Life Outcomes ◽

10.1186/s12955-019-1220-z ◽

2019 ◽

Vol 17 (1) ◽

Cited By ~ 12

Author(s):

Samantha Cruz Rivera ◽

Derek G. Kyte ◽

Olalekan Lee Aiyegbusi ◽

Anita L. Slade ◽

Christel McMullan ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Clinical Trials ◽

Case Studies ◽

Real World ◽

Clinical Trial Data ◽

Research Impact ◽

Trial Data ◽

Patient Reported ◽

The Impact

Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. Methods Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. Results Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. Conclusions PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. Trial registration Systematic Review registration PROSPERO CRD42017067799.

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