Development and Validation of a Method to Estimate COPD Severity in Multiple Datasets: A Retrospective Study.

INTRODUCTION: Outcomes in chronic obstructive pulmonary disease (COPD) such as symptoms, hospitalisations and mortality rise with increasing disease severity. However, the heterogeneity of electronic medical records presents a significant challenge in measuring severity across geographies. We aimed to develop and validate a method to approximate COPD severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 classification scheme, which categorises patients based on forced expiratory volume in 1 s, hospitalisations and the modified Medical Research Council dyspnoea scale or COPD Assessment Test. METHODS: This analysis was part of a comprehensive retrospective study, including patients sourced from the IQVIA Medical Research Data [IMRD; incorporating data from The Health Improvement Network (THIN), a Cegedim database] and the Clinical Practice Research Datalink (CPRD) in the UK, the Disease Analyzer in Germany and the Longitudinal Patient Data in Italy, France and Australia. Patients in the CPRD with the complete set of information required to calculate GOLD 2011 groups were used to develop the method. Ordinal logistic models at COPD diagnosis and at index (first episode of triple therapy) were then used to validate the method to estimate COPD severity, and this was applied to the full study population to estimate GOLD 2011 categories. RESULTS: Overall, 4579 and 12,539 patients were included in the model at COPD diagnosis and at index, respectively. Models correctly classified 74.4% and 75.9% of patients into severe and non-severe categories at COPD diagnosis and at index, respectively. Age, gender, time between diagnosis and start of triple therapy, healthcare resource use, comorbid conditions and prescriptions were included as covariates. CONCLUSION: This study developed and validated a method to approximate disease severity based on GOLD 2011 categories that can potentially be used in patients without all the key parameters needed for this calculation.

Prescribing Pathways to Triple Therapy: A Retrospective Observational Study of Adults with Chronic Obstructive Pulmonary Disease in the UK.

Purpose: Treatment guidance for chronic obstructive pulmonary disease (COPD) recommends inhaled corticosteroid (ICS)+long-acting muscarinic antagonist+long-acting ß2-agonist (LABA) triple therapy for patients who experience recurrent exacerbations, persistent breathlessness, or exercise limitation on dual therapy. However, information is limited on pathways to triple therapy in the UK. Patients and Methods: A retrospective cohort study was conducted using de-identified patient-level data from UK primary care electronic medical records from January 1, 2005 to May 1, 2016. Data were included from patients who had their first triple therapy regimen (index date) recorded during the study period and a minimum of 12 months' pre-index data. Treatment pathways to triple therapy were recorded, and the proportion of patients on triple therapy before their COPD diagnosis was determined. Adherence to triple therapy was estimated using the proportion of days covered (PDC). Results: After applying eligibility criteria, 82,300 patients were included, with a mean age at COPD diagnosis of 64.7 years. The major treatment pathway (27.9%) was the first initiation of ICS+LABA prior to triple therapy. Following COPD diagnosis, the median time to triple therapy was approximately 3.5 years. The estimated mean adherence to triple therapy was 81.8% PDC. Multivariate analysis showed that the following groups were more likely to have received previous therapy prior to triple therapy: females (versus males), patients with asthma (versus those without asthma), severe COPD (versus those with non-severe COPD), or fewer exacerbations (versus those with more exacerbations). Conclusion: Treatment pathways to triple therapy in the UK are diverse, highlighting the need to better understand factors involved in clinical decision-making.

Prescribing Pathways to Triple Therapy: A Multi-Country, Retrospective Observational Study of Adult Patients with Chronic Obstructive Pulmonary Disease.

INTRODUCTION: Maintenance treatment strategies in COPD recommend inhaled corticosteroid (ICS) + long-acting muscarinic antagonist (LAMA) + long-acting ß2-agonist (LABA) triple therapy after initial dual therapy. Little is known about how treatment pathways to triple therapy vary across countries in clinical practice. METHODS: This multi-country, retrospective cohort study (conducted 1 January 2005-1 May 2016) included patients with a COPD diagnosis, and (UK only) evidence of smoking history, or (France, Italy, Germany, and Australia) an indicator confirming COPD diagnosis, a first instance of triple therapy recorded during the study period and ≥ 12 months of data prior to this date. Treatment pathways to triple therapy were analyzed in patients whose first instance of triple therapy was on or after the initial COPD diagnosis. The proportion of patients who initiated triple therapy prior to initial COPD diagnosis was also estimated. Meta-analyses of the main results were performed. RESULTS: In 130,729 patients across all countries, mean age (standard deviation) ranged from 63.4 (10.4) years (Germany) to 69.8 (9.9) years (Italy), and median time (interquartile range) from initial COPD diagnosis to first prescription of triple therapy ranged from 16.9 (5.7-36.2) months (Australia) to 42.5 (13.9-87.4) months (UK). ICS + LABA was the most common treatment pathway prior to triple therapy in the UK, Germany, and Italy (27.3%-31.6%); no previous maintenance therapy prior to triple therapy was the most common pathway in France and Australia (32.5% and 37.9%, respectively). Meta-analyses provided a pooled estimate of 20.4% (95% confidence interval: 13.8%-29.1%) for the proportion of patients initiating triple therapy at or before initial COPD diagnosis. CONCLUSIONS: In this retrospective cohort study, treatment pathways to triple therapy were diverse within and between countries. The differing impact of treatments may affect quality of life and disease control in patients with COPD. Further analyses should investigate factors influencing pathways to triple therapy.

Progression from Early/Intermediate to Advanced Forms of Age-Related Macular Degeneration in a Large UK Cohort: Rates and Risk Factors.

PURPOSE: To estimate rates and risk factors for progression to geographic atrophy (GA) or choroidal neovascularization (CNV) among eyes diagnosed with early or intermediate age-related macular degeneration (AMD) in clinical practice. DESIGN: Retrospective cohort analysis of a multicenter electronic medical record (EMR) database from the United Kingdom. PARTICIPANTS: Patients aged 50 years or more with diagnosis of early/intermediate AMD in at least 1 eye (the study eye) and no evidence of CNV or GA in the study eye, from 10 clinical sites using the EMR. METHODS: Anonymized data for 40 543 patients with a diagnosis of early/intermediate AMD were extracted between October 2000 and February 2016 from EMR database records held in the 10 sites. A sample of records randomly selected from each center was used to validate disease definitions. Records were analyzed by subgroup, based on the AMD status of the fellow eye. Multivariate Cox regression models identified other predictors of disease progression. MAIN OUTCOME MEASURES: Progression rate (per 100 person-years) to GA or CNV in study eyes with early/intermediate AMD by fellow eye status and identified risk factors for progression. RESULTS: Study eyes with early/intermediate AMD and a diagnosis of CNV in the fellow eye progressed to CNV fastest (at a rate of 15.2 per 100 person-years), and those with a diagnosis of GA in the fellow eye progressed to GA fastest (11.2 per 100 person-years), compared with the rates per 100 person-years of progression to CNV (3.2-11.9) or GA (2.0-7.8) in the other subgroups. In individuals with bilateral early/intermediate AMD, rates of progression to GA or CNV were 2.0 and 3.2 per 100 person-years, respectively. In the multivariate model, age, female sex, and cardiovascular disease were associated with an increased risk for progression to advanced AMD, whereas diabetes and glaucoma were associated with a decreased rate of progression (hazard ratios, 0.45 and 0.64, respectively). CONCLUSIONS: Progression to GA or CNV was observed frequently in eyes with early/intermediate AMD, with the status of the fellow eye affecting the rate of progression. Novel associations with risk factors were observed and require replication in other cohorts.

5 year incidence of YAG capsulotomy and PCO after cataract surgery with single-piece monofocal intraocular lenses: a real-world evidence study of 20,763 eyes.

OBJECTIVES: To evaluate the 3- and 5-year incidence of posterior capsule opacification (PCO) and neodymium-doped yttrium aluminium garnet (Nd:YAG) capsulotomy in patients following cataract surgery, comparing results for different single-piece acrylic hydrophilic and hydrophobic monofocal intraocular lens (IOL) models and other patient factors. PATIENTS AND METHODS: Electronic medical record data collected from seven United Kingdom (UK) National Health Service (NHS) ophthalmology clinics for routine, age-related (≥65 years) cataract surgeries that implanted single-piece acrylic monofocal IOLs during 2010-2013 were used to calculate 3- and 5-year incidence of Nd:YAG and PCO. IOL models of Alcon Acrysof, AMO Tecnis, Bausch & Lomb (B & L) Akreos, LenStec Softec, and Rayner Flex were analyzed. Pairwise comparisons were conducted between AcrySof IOLs and other IOLs using Bonferroni adjustment for multiplicity. Multivariate analyses were conducted adjusting for known confounders. RESULTS: The incidence of Nd:YAG capsulotomy ranged between 2.4-12.6% at 3 years and 5.8-19.3% at 5 years post-cataract surgery. Similarly, the incidence of PCO ranged between 4.7-18.6% at 3 years and 7.1-22.6% at 5 years. When comparing all of the single-piece IOLs, AcrySof demonstrated the lowest incidence rates for both PCO and Nd:YAG (P < 0.001 for each comparison). From adjusted logistic regression analysis, AcrySof were associated with lower 3- and 5-year odds of Nd:YAG and PCO incidence. CONCLUSIONS: Following cataract surgery with single-piece monofocal IOLs different incidence rates of PCO were observed with different IOLs. AcrySof IOLs were associated with significantly lower incidence of PCO requiring Nd:YAG treatment over periods of 3 and 5 years.

Direct Ophthalmic Healthcare Resource Use among Patients with Geographic Atrophy in a Large Cohort from the United Kingdom.

PURPOSE: To estimate the direct ophthalmic healthcare resource use in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). DESIGN: Retrospective analysis of anonymized data derived from electronic medical records (EMRs) acquired at 10 clinical sites in the United Kingdom. PARTICIPANTS: Patients aged ≥50 years with ≥1 eye with a clinical record of GA or, for comparison, bilateral early/intermediate AMD. Four subgroups were identified: GA in both eyes (GA:GA); GA in 1 eye, choroidal neovascularization (CNV) in the fellow eye (GA:CNV); GA in 1 eye with early or intermediate AMD in the fellow eye (GA:E); and early/intermediate AMD in both eyes (E:E). METHODS: The EMRs were analyzed to derive the median number of visits over the first 2 years after diagnosis of GA or early/intermediate AMD. Clinical tests recorded at visits were used to calculate estimated costs (payer perspective) of monitoring. Analyses were restricted to patients with an initial diagnosis on or after January 1, 2011, to represent present day monitoring and costs associated with AMD. MAIN OUTCOME MEASURES: Median number of visits and estimated monitoring costs per patient (in £) over the first 2 years among patients with ≥2 years of follow-up and in the individual subgroups. Intravitreal treatment costs in the GA:CNV group were excluded. RESULTS: For all 3 GA subgroups (n = 1080), the median number of visits over the first 2 years was 5, and monitoring costs were £460.80 per patient. The GA:CNV subgroup (n = 355) had the highest number of visits (median, 15), with a cost of £1581, compared with the GA:E subgroup (n = 283; median 4 visits; cost ∼£369) and the GA:GA subgroup (n = 442; median 3 visits; cost ∼£277). Ophthalmic tests were conducted most frequently in the GA:CNV subgroup. Visits and costs in the E:E subgroup (n = 6079) were lower. CONCLUSIONS: Resource use in patients with GA varies considerably and is strongly influenced by the concomitant presence of CNV and lack of monitoring strategies for GA.

Three-year incidence of Nd:YAG capsulotomy and posterior capsule opacification and its relationship to monofocal acrylic IOL biomaterial: a UK Real World Evidence study.

PURPOSE: To evaluate 3-year incidence of Nd:YAG capsulotomy and PCO and compare the effect of different IOL materials. METHODS: Data were retrospectively collected from seven UK ophthalmology clinics using Medisoft electronic medical records. Eyes from patients ≥65 years undergoing cataract surgery with implantation of acrylic monofocal IOLs during 2010-2013 and 3-year follow-up were analysed. Nd:YAG capsulotomy and PCO incidence proportions were reported for 3 IOL cohorts: AcrySof, other hydrophobic and hydrophilic acrylic IOLs. Unadjusted/adjusted odds ratios (OR) of Nd:YAG capsulotomy were calculated through logistic regression for non-AcrySof cohorts versus AcrySof. A sub-group analysis in single-piece IOLs (>90% of sample eyes) was also performed. RESULTS: The AcrySof cohort included 13,329 eyes, non-AcrySof hydrophobic 19,025 and non-AcrySof hydrophilic 19,808. The 3-year Nd:YAG capsulotomy incidence (95% CI) for AcrySof (2.4%, 2.2-2.7%) was approximately two times lower than non-AcrySof hydrophobic IOLs (4.4%, 4.1-4.7%) and approximately fourfold lower than non-AcrySof hydrophilic IOLs (10.9%, 10.5-11.3%). Trends were similar in PCO incidence (AcrySof: 4.7%; non-AcrySof hydrophobic: 6.3%; non-AcrySof hydrophilic: 14.8%). Also in the analysis restricted to single-piece IOLs, the pattern remained (2.4% vs 5.1% vs. 10.9%, respectively). Adjusted regression analysis showed a approximately two and fivefold increased odds of Nd:YAG for non-AcrySof hydrophobic and hydrophilic acrylic IOLs respectively vs. AcrySof IOLs. Nd:YAG capsulotomy ORs were similar and remained statistically significant in the single-piece IOL sub-group. CONCLUSIONS: Real-world evidence shows that within 3 years following implantation, AcrySof IOLs are significantly superior in reducing Nd:YAG capsulotomy and PCO incidence compared to other hydrophilic and hydrophobic acrylic IOLs.