Dutch Chronic Pancreatitis Registry (CARE): design and rationale of a nationwide prospective evaluation and follow-up.

BACKGROUND: Chronic pancreatitis is a complex disease with many unanswered questions regarding the natural history and therapy. Prospective longitudinal studies with long-term follow-up are warranted. METHODS: The Dutch Chronic Pancreatitis Registry (CARE) is a nationwide registry aimed at prospective evaluation and follow-up of patients with chronic pancreatitis. All patients with (suspected) chronic or recurrent pancreatitis are eligible for CARE. Patients are followed-up by yearly questionnaires and review of medical records. Study outcomes are pain, disease complications, quality of life, and pancreatic function. The target sample size was set at 500 for the first year and 1000 patients within 3 years. RESULTS: A total of 1218 patients were included from February 2010 until June 2013 by 76 participating surgeons and gastroenterologist from 33 hospitals. Participation rate was 90% of eligible patients. Eight academic centers included 761 (62%) patients, while 25 community hospitals included 457 (38%). Patient centered outcomes were assessed by yearly questionnaires, which had a response rate of 85 and 82% for year 1 and 2, respectively. The median age of patients was 58 years, 814 (67%) were male, and 38% had symptoms for less than 5 years. DISCUSSION: The CARE registry has successfully recruited over 1200 patients with chronic and recurrent pancreatitis in about 3 years. The defined inclusion criteria ensure patients are included at an early disease stage. Participation and compliance rates are high. CARE offers a unique opportunity with sufficient power to investigate many clinical questions regarding natural course, complications, and efficacy and timing of treatment strategies.

Exploring experiences and health-related quality of life of caregivers of patients who start home dialysis: study protocol for a prospective, multicentre cohort study.

INTRODUCTION: Starting dialysis not only has a major impact on the life of patients but also on their informal caregivers. Previous research shows greater burden and lower quality of life among caregivers of dialysis patients compared with the general population. Unfortunately, the evidence on the course of both positive and negative experience in caregivers of incident dialysis patients is scarce. Furthermore, well-designed, prospective, multicentre studies comparing caregiving of home dialysis patients with in-centre dialysis patients are lacking. This paper proposes a protocol to assess the trajectory of experiences (both positive and negative) and quality of life of caregivers of home dialysis patients compared with caregivers of in-centre dialysis patients. METHODS AND ANALYSIS: This paper presents a protocol for a prospective, observational, multicentre cohort study which extends the ongoing Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO). This study will include at least 200 adult caregivers of patients who start dialysis therapy and have been included in the DOMESTICO study. Positive experiences of the caregivers will be the primary outcome parameter of this study, and negative experiences and health-related quality of life the secondary outcome parameters. Required support will be investigated as an exploratory finding. Outcome parameters will be assessed at baseline, and at 6 and 12 months after start of dialysis using validated questionnaires. ETHICS AND DISSEMINATION: Ethical approval for this study has been obtained from the Medical Research Ethics Committee of the Amsterdam University Medical Centre. The results of this study will be disseminated by publication in a peer-reviewed journal and through presentations at conferences and seminars.