ABSTRACT
INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is a common but under-diagnosed pathology in primary care. The objective was to study the feasibility of a randomized controlled trial in general practice to detect new cases of COPD at an earlier stage. METHODS: A cluster randomized, controlled, multicenter intervention study comparing, according to a 2×2 factorial plan, two case finding strategies: a systematic GOLD-HAS hetero-questionnaire and coordination of the patient's path to facilitate access to spirometry. The PIL-DISCO pilot study took place in 2017. Patients between 40 and 80 years old, with no previous history of COPD, consulting their GP on a given day regardless of the reason, were included. RESULTS: 176 patients were included in 1.5 days. Spirometry was performed in none of the control arm, in 13 (29.5%) of the questionnaire arm, in 22 (50%) in the coordination arm and in 32 (72.7%) with the combination of the two strategies. Two cases of stage 2 COPD and thirteen other respiratory diseases were diagnosed. CONCLUSIONS: This study confirms the feasibility of the protocol in primary care in terms of speed of inclusion and acceptability. An extension phase aiming to include 3200 patients will assess the diagnostic value of the two strategies tested in general practice.
Subject(s)
Mass Screening/methods , Primary Health Care/methods , Pulmonary Disease, Chronic Obstructive/diagnosis , Adult , Aged , Aged, 80 and over , Early Diagnosis , Feasibility Studies , Female , Forced Expiratory Volume , General Practice/methods , Humans , Male , Middle Aged , Program Evaluation , Spirometry/methodsABSTRACT
BACKGROUND: In liver transplant recipients with hepatitis C virus recurrence, there is concern about renal safety of sofosbuvir-based regimens. Changes in serum creatinine or in the estimated glomerular filtration rate (eGFR) under treatment are used to look for possible renal toxicity. However, serum creatinine and eGFR are highly variable. AIM: To analyse renal function trajectory with numerous assays of serum creatinine over a long period of time. METHODS: In a multicentre cohort of 139 patients, the eGFR was obtained from serum creatinine using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation. Slopes of eGFR were defined as a change in eGFR during a period divided by time. Pre-treatment, on-treatment and post-treatment periods were 9 months, 3-9 months and 4.5 months. Interactions between eGFR slopes and the pre-treatment eGFR, use of ribavirin or mycophenolate mofetil, and stage of fibrosis were addressed. On-treatment eGFR slopes were separated in tertiles. Pre- and post-treatment eGFR slopes were compared globally and according to tertiles. RESULTS: The post-treatment eGFR slope was significantly better than pre-treatment eGFR slope (+0.18 (IQR -0.76 to +1.32) vs -0.11 (IQR -1.01 to +0.73) mL/min/1.73 m2 /month, P = 0.03) independently of the pre-treatment eGFR (P = 0.99), ribavirin administration (P = 0.26), mycophenolate mofetil administration (P = 0.51) and stage of fibrosis (F3 and F4 vs lower stages, P = 0.18; F4 vs lower stages, P = 0.08; F4 Child-Pugh B and C vs lower stages, P = 0.38). Tertiles of on-treatment eGFR slopes were -1.71 (IQR -2.54 to -1.48), -0.78 (IQR -1.03 to -0.36) and +0.75 (IQR +0.28 to +1.47) mL/min/1.73 m2 /month. Pre- and post-treatment eGFR slopes were not significantly different according to tertiles (respectively, P = 0.34, 0.08, 0.73). CONCLUSION: The eGFR varies during treatment and gives a confusing picture of the renal safety of sofosbuvir-based regimens. In contrast, longitudinal assessment of the eGFR shows a rising trajectory over longer time, meaning that these therapies are safe for the kidneys in our cohort of liver transplant recipients.
