[Why nurses fly and surgeons rotate. The surgical study network CHIR-Net]. / Warum Schwestern fliegen und Ärzte rotieren. Das chirurgische Studiennetzwerk CHIR-Net.

BACKGROUND: The German National Surgical Trial Network (CHIR-Net) which has been funded since 2006 by the Federal Ministry of Education and Research (BMBF, funding code 01GH1001A-01GH1001F, 01GH0702) is made up of eight regional surgical centers. The aim of the CHIR-Net is the design, implementation and publication of prospective, randomized, multicenter trials to support evidence-based medicine in surgery. Two main pillars of the CHIR-Net are the surgeon on rotation program and the flying study nurse program. With these two programs the surgical hospitals are supported in their trial working by educating competent investigators and the infrastructural support of flexible and mobile study nurses. METHODS: The surgeon on rotation program and the concept of the flying study nurse are presented descriptively. Furthermore, this paper provides reports of experiences of a surgeon on rotation and a flying study nurse of the CHIR-Net. Additionally, the results of an on-line evaluation of the regional surgical hospitals (belonging to the regional surgical center of the universities Witten/Herdecke and Cologne) regarding the needs and requirements of the regional surgical hospitals are presented. RESULTS: The surgeon on rotation program of the CHIR-Net offers investigators the possibility to acquire the basics of designing, developing and implementation of high quality clinical trials. In addition, their own study projects could be intensively driven forward. The flying study nurse program enables in particular non-university surgical hospitals to be supported competitively in performing their own study projects and participating in muliticenter clinical trials. The success of these two programs has been confirmed by the conducted evaluations and the presented field reports. CONCLUSION: The CHIR-Net is able to develop a high quality study culture in Germany with its surgeon on rotation and flying study nurse program. In addition to the funding period by the BMBF, the continuance of the CHIR-Net should be a primary aim of further measures.

Nursing research and participant recruitment: organizational challenges and strategies.

Hospitals as research environments are crucial in advancing evidence-based practice and translational research. The authors discuss issues related to hospital-based nursing research such as institutional review board approval, the HIPAA, structure, unit characteristics, and nurse staffing as well as research-related issues such as study purpose and design, participant recruitment, and research personnel. Strategies and suggestions for nurse executives to assist researchers in overcoming recruitment challenges are presented.

The soft option. Interview by Louise Hunt.

A study is recruiting 310 children in hard water areas of England to test anecdotal evidence that water softeners reduce the symptoms of eczema.

Research team training: moving beyond job descriptions.

Providing appropriate training to research team members is essential to the effective implementation and overall operation of a research project. It is important to identify job requirements beyond those listed in the job description in order to fully assess basic and supplementary training needs. Training needs should be identified prior to and during the conduct of the study. Methods for delivering the training must also be identified. This article describes the identification of training needs and methods in the design of a research team training program using examples from an HIV prevention intervention trial with adolescent girls.

The role and potential contribution of clinical research nurses to clinical trials.

AIMS AND OBJECTIVES: This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. BACKGROUND: Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. DESIGN: Qualitative focus group study. METHODS: A focus group interview was carried out with CRNs (n = 9) employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside field notes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. FINDINGS: CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. CONCLUSIONS: The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal 'participant observers.' Such observations enhance understanding of the contexts being studied. RELEVANCE TO CLINICAL PRACTICE: These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

Co-bedding twins: how pilot study findings guided improvements in planning a larger multicenter trial.

BACKGROUND: Co-bedding, a developmental care practice for twins and multiples, has been theorized as a strategy to decrease the adverse neurodevelopmental effects that may be associated with hospitalization. OBJECTIVE: The aim of this study was to determine the feasibility of study design, methods, and the measurement of desired outcomes for the development of a larger multicentered study. RESULTS: Study findings were used to estimate effect size, determine staff and bedside care organization, evaluate feasibility of data collection measures, and identify issues related to recruitment and follow-up. Results were incorporated in the development of a larger multicentered trial grant proposal. DISCUSSION: Pilot studies can play an important role in the development of a competitive grant proposal and efficient conduct of a research trial. Pilot studies strengthen a proposal by providing essential baseline information. A general overview of the purpose of pilot studies is provided here, along with a description of the process of using findings from a pilot study to inform the development of a larger multisite trial. Findings from this pilot study examining the effects of co-bedding on twins and their parents are used to revise the research protocol for a larger multisite trial. These changes, which lead to improvement to the protocol, and the rational for these changes are highlighted.

Home visiting for intervention delivery to improve rural family asthma management.

The focus of this article is on the use of home visits in an asthma self-management intervention study with rural families who have a school-aged child with asthma. The study design involved randomization of the sample by elementary schools, then baseline (pretest) and postintervention data collection.(1) The purpose of this article is to describe challenges with, and pose solutions for, implementing home visits for asthma self-management in rural areas. Home visiting is a strategy for program delivery that takes advantage of the home context for tailoring services to address the family's individual needs. The advantages of intervening in the home include being able to (a) use actual home conditions for individualizing the asthma education to meet families' needs; (b) match home visitors with family in terms of ethnicity and language; (c) retain a high percentage of families over the year-long duration of the study; and (d) not add to family burden of managing asthma.

Issues in nursing: strategies for an Internet-based, computer-assisted telephone survey.

The study describes the design and implementation of an Internet-based, computed-assisted telephone survey about the care-planning process in 107 long-term care facilities in the Midwest. Two structured telephone surveys were developed to interview the care planning coordinators and their team members. Questionmark Perception Software Version 3 was used to develop the surveys in a wide range of formats. The responses were drawn into a database that was exported to a spreadsheet format and converted to a statistical format by the Information Technology team. Security of the database was protected. Training sessions were provided to project staff. The interviews were tape-recorded for the quality checks. The inter-rater reliabilities were above 95% to 100% agreement. Investigators should consider using Internet-based survey tools, especially for multisite studies that allow access to larger samples at less cost. Exploring multiple software systems for the best fit to the study requirements is essential.

Multicentre research: lessons from the field.

Multicentre research can be used to explore and generate significant data in aspects of care that affect small numbers of children. This article describes the problems and benefits encountered by a group of nurses from 11 hospitals undertaking a multicentre study of pressure ulcers in children and young people in England and Wales. Multicentre research can generate a large amount of useful data contributing to high quality evidence-based care and can provide nurses with a valuable learning and networking experience.

Barriers to conducting randomised controlled trials: lessons learnt from the Horsechestnut & Venous Leg Ulcer Trial (HAVLUT).

The RCT is considered the gold standard for testing a therapeutic intervention. However, the conduct of an RCT is not without numerous obstacles. As illustrated through the recent Horsechestnut and Venous Leg Ulcer Trial (HAVLUT), these barriers can be attributed to randomisation, recruitment, retention, blinding and sampling procedures, and to gate keeping. These obstacles, together with strategies to prevent and overcome them, are detailed throughout this article, and are aimed at ameliorating the future design and conduct of RCTs.

Conduct of multisite clinical studies by professional organizations.

ISSUES AND PURPOSE: Professional organizations are embracing collaborative multisite research and research utilization projects. This report describes the strategies undertaken and lessons learned from SPN's first multisite study. CONCLUSIONS: Infrastructure concerns (e.g., vision, communication, dissemination of results, resources, and human rights protections) and methodological issues specific to multisite research must be addressed to ensure a successful study. PRACTICE IMPLICATIONS: Multisite studies are an effective mechanism for more rapidly advancing nursing theory and evidence-based nursing practice.