The cost effectiveness of a randomized controlled trial to establish the relative efficacy of vitamin K1 compared with alendronate.

PURPOSE: The authors aimed to evaluate whether vitamin K(1) or alendronate (the recommended treatment in England and Wales for postmenopausal women with a previous fracture) appeared to be the more cost-effective treatment for fracture prevention. Furthermore, expected value of sample information (EVSI) analyses were undertaken to estimate whether a head-to-head trial of alendronate and vitamin K(1) would be considered cost effective. METHOD: A published osteoporosis model structure, populated with data from literature reviews, was used to evaluate the costs and quality-adjusted life-years associated with each intervention being provided to women at high risk of fracture, given current information. A lifetime horizon and a national health service and personal social services cost perspective were used. Observed outcomes from head-to-head randomized controlled trials (RCTs) of predetermined sizes were simulated and synthesized with existing data to formulate posterior distributions, which were used to estimate the more cost-effective treatment given these additional data. The EVSI was estimated and the expected net benefit of sampling (ENBS) calculated by subtracting the proposed trial costs. RESULTS: Given current information, vitamin K(1) is expected to dominate alendronate. However, this was subject to a considerable degree of uncertainty; dominance was reversed when it was assumed that vitamin K(1) had no effect on hip fractures. EVSI analysis indicated that an RCT of 2000 or 5000 women per arm produced high, and comparable, ENBS. These results were maintained in sensitivity analyses. CONCLUSIONS: It is concluded that an RCT recruiting between 2000 and 5000 women per arm to evaluate the relative efficacy of alendronate and vitamin K(1) appears to be cost effective for informing decision making in England and Wales.

Role development and effective practice in specialist and advanced practice roles in acute hospital settings: systematic review and meta-synthesis.

AIMS: This paper reports a study whose aim was to identify and synthesize qualitative research studies reporting barriers or facilitators to role development and/or effective practice in specialist and advanced nursing roles in acute hospital settings. BACKGROUND: The number of clinical nurse specialist, nurse practitioner, advanced nurse practitioner and consultant nurse roles has grown substantially in recent years. Research has shown that nurses working in innovative roles encounter a range of barriers and facilitators to effective practice. METHODS: Systematic literature searches were undertaken, and relevant studies identified using specific inclusion and exclusion criteria. The selected studies were appraised, and their findings synthesized using Ritchie and Spencer's 'Framework' approach. RESULTS: Fourteen relevant studies were identified, mostly from the UK. They described a range of barriers and facilitators affecting specialist and advanced nursing practice. These related to the practitioner's personal characteristics and previous experience, professional and educational issues, managerial and organizational issues, relationships with other health care professionals, and resources. The factors most widely identified as important were relationships with other key personnel, and role definitions and expectations. CONCLUSIONS: Relationships with other staff groups and role ambiguity are the most important factors which hinder or facilitate the implementation of specialist and advanced nursing roles. These factors seem interlinked, and the associated problems do not appear to resolve spontaneously when staff become familiar with the new roles. In order to reduce role ambiguity and the consequent likelihood of negative responses we recommend that, when specialist and advanced nursing roles are introduced, clear role definitions and objectives are developed and communicated to relevant staff groups; these definitions and objectives should be updated as necessary.

Application of systematic review methods to qualitative research: practical issues.

AIM: This paper explores practical methodological issues which arise from the application of systematic review and meta-synthesis techniques to qualitative research studies in the context of a pragmatic health services research question. BACKGROUND: The emphasis on, and volume of, qualitative research is increasing. As a result, there is a need to integrate and disseminate qualitative research findings. However, relatively little has been written about the methodology of systematically reviewing and meta-synthesizing qualitative research studies, and about the practical issues which arise in the course of these processes. METHODS: A systematic review and meta-synthesis was undertaken of qualitative research studies reporting data relevant to the pragmatic health services research question: "What factors facilitate or impede role development and/or effective practice as a clinical nurse specialist, nurse practitioner, advanced nurse practitioner or consultant nurse based in acute hospital settings?" FINDINGS: The identification of relevant studies is substantially more time-consuming than the identification of relevant studies for a systematic review of randomized controlled trials. A substantially larger proportion of papers has to be retrieved for full reading. Articles with unclear titles which lack abstracts cannot be dismissed as irrelevant. Study appraisal and data analysis, being iterative processes, are also more time-consuming than the appraisal and meta-analysis of quantitative studies. It may be possible to reduce the frustrations inherent in the distance between the reviewer and the participants in the primary research by using full project reports rather than published articles. CONCLUSIONS: Conducting a systematic review and meta-synthesis of qualitative research studies is a rewarding but demanding activity, and adequate time and resources must be made available. Some recommendations are made which may facilitate those processes.