Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission: study protocol of a prospective, multicentre, randomized clinical trial

Background: Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy. The primary study aim is to compare the rates of clinical remission at 1?year in patients who discontinue anti-TNF treatment versus those who continue treatment. Methods: This is an ongoing, prospective, double-blind, multicentre, randomized, placebo-controlled study in patients with Crohn?s disease or ulcerative colitis who have achieved clinical remission for ?6?months with an anti-TNF treatment and an immunosuppressant. Patients are being randomized 1:1 to discontinue anti-TNF therapy or continue therapy. Randomization stratifies patients by the type of inflammatory bowel disease and drug (infliximab versus adalimumab) at study inclusion. The primary endpoint of the study is sustained clinical remission at 1?year. Other endpoints include endoscopic and radiological activity, patient-reported outcomes (quality of life, work productivity), safety and predictive factors for relapse. The required sample size is 194 patients. In addition to the main analysis (discontinuation versus continuation), subanalyses will include stratification by type of inflammatory bowel disease, phenotype and previous treatment. Biological samples will be obtained to identify factors predictive of relapse after treatment withdrawal. Results: Enrolment began in 2016, and the study is expected to end in 2020. Conclusions: This study will contribute prospective, controlled data on outcomes and predictors of relapse in patients with inflammatory bowel disease after withdrawal of anti-TNF agents following achievement of clinical remission. Clinical trial reference number: EudraCT 2015-001410-1

Characteristics and outcomes of chronic pain patients referred to hospital pain clinics: a prospective observational study

BACKGROUND: Understanding the patient referral patterns and medical profiles of patients attending hospital pain clinics, and the therapies offered to them, can provide a useful starting point for evaluating their effectiveness and identifying areas for improvement. METHODS: A prospective observational study was carried out. Sociodemographic and clinical data were gathered at twelve centres. The diagnoses and pain treatments provided by the referring doctors were compared with the ones provided by pain clinicians. Pain severity and patients' quality of life were measured prospectively. Descriptive statistics were compared. RESULTS: Two-hundred sixty-nine patients referred to 12 outpatient hospital pain clinics in Catalonia were followed for 3 months. Most were referred by orthopaedists (50.0%) or primary care physicians (20.2%). The mean age and time since pain onset were 59.4 and 4.1 years, respectively. Pain clinicians changed the diagnostic labels of 48.5% of the patients. Nearly all patients (89.2%) were receiving pain medications prior to referral. Treatment was modified in 94.8%. Pain clinicians used more interventional and/or alternative therapies (65.1% of patients), opioids (46.8%) and co-adjuvants (38.2%). Three months after referral, the 24-h worst and current pain severity had decreased by 30.9% and 27.8% on average, respectively. The mean (effect size) improvements in a quality of life (the EuroQol 5 Dimensions index) and pain (visual analogue scale) scores were, respectively, 0.16 (0.73) and 6.7 (0.31). CONCLUSIONS: Pain clinicians refined the diagnoses and treatments of patients referred to hospital pain clinics and improved outcomes. Relatively few patients are referred from primary care considering the prevalence of chronic pain in this setting.This research received funds from Laboratorios del Doctor Esteve, S.A

Characteristics and outcomes of chronic pain patients referred to hospital pain clinics: a prospective observational study

BACKGROUND: Understanding the patient referral patterns and medical profiles of patients attending hospital pain clinics, and the therapies offered to them, can provide a useful starting point for evaluating their effectiveness and identifying areas for improvement. METHODS: A prospective observational study was carried out. Sociodemographic and clinical data were gathered at twelve centres. The diagnoses and pain treatments provided by the referring doctors were compared with the ones provided by pain clinicians. Pain severity and patients' quality of life were measured prospectively. Descriptive statistics were compared. RESULTS: Two-hundred sixty-nine patients referred to 12 outpatient hospital pain clinics in Catalonia were followed for 3 months. Most were referred by orthopaedists (50.0%) or primary care physicians (20.2%). The mean age and time since pain onset were 59.4 and 4.1 years, respectively. Pain clinicians changed the diagnostic labels of 48.5% of the patients. Nearly all patients (89.2%) were receiving pain medications prior to referral. Treatment was modified in 94.8%. Pain clinicians used more interventional and/or alternative therapies (65.1% of patients), opioids (46.8%) and co-adjuvants (38.2%). Three months after referral, the 24-h worst and current pain severity had decreased by 30.9% and 27.8% on average, respectively. The mean (effect size) improvements in a quality of life (the EuroQol 5 Dimensions index) and pain (visual analogue scale) scores were, respectively, 0.16 (0.73) and 6.7 (0.31). CONCLUSIONS: Pain clinicians refined the diagnoses and treatments of patients referred to hospital pain clinics and improved outcomes. Relatively few patients are referred from primary care considering the prevalence of chronic pain in this setting.This research received funds from Laboratorios del Doctor Esteve, S.A