Test, evidence, transition projects in Scotland: developing the evidence needed for transition of effective interventions in cancer care from innovation into mainstream practice.

BACKGROUND: A robust evidence base is required to assist healthcare commissioners and providers in selecting effective and sustainable approaches to improve cancer diagnosis and treatment. Such evidence can be difficult to build, given the fast-paced and highly pressured nature of healthcare delivery, the absence of incentives, and the presence of barriers in conducting pragmatic yet robust research evaluations. Cancer Research UK (CRUK) has played an active part in building the evidence base through its funding of programmes to identify, evaluate and scale-up innovative approaches across the UK. The aim of this paper is to describe and explain the research design and intended approach and activities for two cancer services improvement projects in Scotland funded by CRUK. METHODS: A hybrid effectiveness-implementation study design will assess both the efficiency of the new pathways and their implementation strategies, with the aim of generating knowledge for scale-up. A range of implementation, service and clinical outcomes will be assessed as determined by the projects' Theories of Change (ToCs). A naturalistic case study approach will enable in-depth exploration of context and process, and the collection and synthesis of data from multiple sources including routine datasets, patient and staff surveys, in-depth interviews and observational and other data. The evaluations are informed throughout by a patient/public representatives' group, and by small group discussions with volunteer cancer patients. DISCUSSION: Our approach has been designed to provide a holistic understanding of how (well) the improvement projects work (in relation to their anticipated outcomes), and how they interact with their wider contexts. The evaluations will help identify barriers, facilitators, and unanticipated consequences that can impact scalability, sustainability and spread. By opting for a pragmatic, participatory evaluation research design, we hope to inform strategies for scaling up successful innovations while addressing challenges in a targeted manner.

Validity of the Rockall scoring system after endoscopic therapy for bleeding peptic ulcer: a prospective cohort study.

BACKGROUND: The Rockall scoring system was developed in unselected patients, the majority of whom did not receive endoscopic therapy. The aim of this study was to assess the validity of the Rockall system in high-risk patients who undergo endoscopic therapy for peptic ulcer hemorrhage. METHODS: Rockall scores were calculated in 247 patients with major peptic ulcer bleeding entered into a randomized trial of endoscopic therapy. The observed rates of recurrent bleeding and mortality after endoscopic therapy were compared with predicted rates derived from Rockall's study group. The validity of the Rockall system was assessed in terms of calibration and discrimination. RESULTS: Rates of recurrent bleeding and mortality after endoscopic therapy increased with an increasing Rockall score. Observed rates of recurrent bleeding and mortality were below predicted rates, and calibration of the Rockall system was poor (Mantel-Haenszel chi square = 25.8, p < 0.0001 for recurrent bleeding; Mantel-Haenszel chi square = 15.1, p < 0.0001 for death). For the prediction of recurrent bleeding, the area under the receiver operating characteristic curve was low (63.4%), but the system was satisfactory when predicting mortality (area under the resulting curve, 84.3%). CONCLUSIONS: After endoscopic therapy for a bleeding peptic ulcer, the Rockall scoring system can identify patients at high risk of death, but it is inadequate for the prediction of recurrent bleeding.