Purpose: International collaboration in research is essential in order to improve worldwide health. The purpose of this paper is to describe strategies used to administer an international multicenter trial to assess the effectiveness of a nursing educational intervention.

Design: The study design was a two-group randomized multicenter international clinical trial conducted to determine whether a brief education and counselling intervention delivered by a nurse could reduce prehospital delay in the event of symptoms suggestive of acute coronary syndrome (ACS) in patients previously diagnosed with cardiovascular disease.

Method: A flexible but well-defined project structure showed intervention consistency in five sites among three countries and included experienced project coordinators, multidimensional communication methods, strategies to optimize intervention fidelity, site-specific recruitment and retention techniques, centralized data management, and consideration of ethical and budgetary requirements.

Findings: Staff at five sites enrolled 3,522 participants from three countries and achieved 80% follow-up obtained at both 12 and 24 months.

Conclusion: Multidimensional approaches to maintain consistency across study sites, while allowing flexibility to meet local expectations and needs, contributed to the success of this trial.

Clinical Relevance: In order to support appropriate development of an evidence base for practice, nursing interventions should be tested in multiple settings. A range of strategies is described in this paper that proved effective in conducting a multicenter international trial.

Download full-text PDF

Source
http://dx.doi.org/10.1111/j.1547-5069.2008.00213.xDOI Listing

Publication Analysis

Top Keywords

multicenter international
12
international clinical
8
clinical trial
8
three countries
8
international
5
effective strategies
4
strategies implementing
4
multicenter
4
implementing multicenter
4
trial
4

Similar Publications

COLOR IV: a multicenter randomized clinical trial comparing intracorporeal and extracorporeal ileocolic anastomosis after laparoscopic right colectomy for colon cancer.

Surg Endosc

December 2024

State Key Lab of Digestive Health, Department of General Surgery, National Clinical Research Center for Digestive Diseases, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.

Introduction: Right-sided colon cancer is a prevalent malignancy. The standard surgical treatment for this condition is laparoscopic right hemicolectomy, with ileocolic anastomosis being a crucial step in the procedure. Recently, intracorporeal ileocolic anastomosis has garnered attention for its minimally invasive benefits.

View Article and Find Full Text PDF

Background: Gastrointestinal subepithelial lesions (SELs) range from benign to malignant. Endoscopic ultrasound (EUS)-guided fine-needle biopsy (EUS-FNB) is used widely for pathological diagnosis of SELs. Early diagnosis and treatment are important because all Gastrointestinal stromal tumors (GISTs) have some degree of malignant potential.

View Article and Find Full Text PDF

Background & Aims: The Crohn's Disease (CD) Exclusion Diet (CDED)+Partial Enteral Nutrition (PEN) is effective for inducing remission in mild-moderate CD. We assessed whether a 2-week course of Exclusive Enteral Nutrition (EEN), followed by CDED+PEN is superior to 8 weeks of EEN in sustaining clinical remission at week 14 in mild-to-severe CD and if CDED+PEN can maintain remission to week 24.

Methods: This international, multicenter, randomized-controlled trial compared 2-weeks of EEN (Modulen®IBD) followed by 3 phases of the CDED+PEN (henceforth CDED) to 8 weeks of EEN, followed by PEN with free diet up to week 24 (henceforth EEN).

View Article and Find Full Text PDF

Impact of enzyme replacement therapy on clinical manifestations in females with Fabry disease.

Orphanet J Rare Dis

December 2024

Department of Internal Medicine D, and Interdisciplinary Fabry Center (IFAZ), University Hospital Muenster, Muenster, Germany.

Background: The aim of our multicenter study was to investigate the implementation of the European Fabry guidelines on therapeutic recommendations in female patients with Fabry disease (FD) and to analyze the impact of enzyme replacement therapy (ERT) in treated and untreated females.

Results: Data from 3 consecutive visits of 159 female FD patients from 6 Fabry centers were retrospectively analyzed. According to their treatment, patients were separated in 3 groups (untreated, n = 71; newly ERT-treated, n = 47; long-term ERT-treated, n = 41).

View Article and Find Full Text PDF

Background: The aim of the study was to determine the level of dietary self-efficacy, physical activity and obesogenic environment in several districts of Istanbul and to examine the relationship between them.

Methods: In this cross-sectional study, a questionnaire was administered to primary health care workers working in three different districts of Istanbul. Sociodemographic questions, Dieting Self-Efficiency Scale (DSES), The Assessment of the Obesogenic Environment Scale (AOES), and International Physical Activity Questionnaire (IPAQ) were used in the survey.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!