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Biomedical subjects

M Lloyd Jones

Publications and source records attributed to M Lloyd Jones.

9 recordsLinked to original sources

A systematic review and economic evaluation of alendronate, etidronate, risedronate, raloxifene and teriparatide for the prevention and treatment of postmenopausal osteoporosis.

OBJECTIVES: To establish the clinical effectiveness and cost-effectiveness of selective oestrogen receptor modulators, bisphosphonates and parathyroid hormone (subject to licensing) for the prevention and treatment of osteoporosis and the prevention of osteoporotic fractures in postmenopausal women. DATA SOURCES: Electronic databases. REVIEW METHODS: Studies that met the review's entry criteria were eligible for inclusion in the meta-analyses provided that they reported fracture incidence in terms of the number of patients suffering fractures. Meta-analysis was carried out using the random-effects model. A model was constructed to estimate the cost-effectiveness of osteoporosis interventions. The model calculated the number of fractures that occurred and provided the costs associated with osteoporotic fractures, and the quality-adjusted life-years (QALYs). In addition, the conditions of breast cancer and coronary heart disease (CHD) were modelled, as some interventions have been shown to affect the risk of these conditions. RESULTS: Ninety randomised controlled trials (RCTs) met the inclusion criteria. They related to the five interventions (alendronate, etidronate, risedronate, raloxifene and teriparatide) and to five comparators (calcium, calcium plus vitamin D, calcitriol, hormone replacement therapy and exercise), as well as placebo or no treatment. All five interventions have been shown to reduce the risk of vertebral fracture in women with severe osteoporosis with adequate calcium intakes. However, none of these drugs has been demonstrated, by direct comparison, to be significantly more effective than either each other or the other active interventions reviewed in this report. The intervention costs of treating all osteoporotic women, for a period of 5 years, were in the region of pound 900-1500 million for alendronate, etidronate, risedronate and raloxifene. The cost per QALY ratios fell dramatically with age. Assuming the risks of a woman with severe osteoporosis at the threshold of osteoporosis, no treatment had a cost per QALY below pound 35,000 at 50 years of age. At 60 years of age, the cost per QALY of raloxifene was pound 26,000 assuming no impact on hip fractures, and pound 31,000 assuming an adverse effect. However, these results are driven by the effect on breast cancer and the assumptions made regarding this disease state. No other intervention had a cost per QALY below pound 35,000. When analyses were conducted assuming that the fracture risk is doubled at each site, alendronate and risedronate had cost per QALY ratios below pound 30,000 at all ages. For women at the threshold of osteoporosis, without a prior fracture and aged 70 years, the cost per QALY of the three bisphosphonates ranged from pound 34,000 to pound 41,000. Raloxifene had a cost per QALY of pound 23,000, assuming no effect on hip fracture, given assumptions regarding breast cancer. At 80 years of age, the cost per QALY of alendronate and risedronate was below pound 20,000. This was true for etidronate when incorporating observational data, but the value rose to pound 69,000 when only RCT data were used. No other intervention had a cost per QALY below pound 35,000. It was assumed that doubling the risk of fracture for women without a prior fracture would give results similar to patients at the threshold of osteoporosis with a prior fracture. CONCLUSIONS: Of the five interventions, only raloxifene appeared to reduce the risk of vertebral fracture in postmenopausal women unselected for low bone mineral density (BMD). However, as the full data have not been made public, there is some uncertainty regarding this result. None of the five interventions has been shown to reduce the risk of non-vertebral fracture in women unselected for low BMD. All of the proposed interventions provided gains in QALYs compared with no treatment in women with sufficient calcium and vitamin D intakes. The size of the QALY gain for each intervention was strongly related to the age of the patient. The estimated costs varied widely for the interventions. These net costs were markedly different by age, with some interventions becoming cost-saving at higher age ranges in patients with a prior fracture. Areas for future research include: the evidence base for the efficacy of fracture prevention in the very elderly, reanalysis of raloxifene using a dedicated breast cancer and CHD model, and more trials considering the cost-effectiveness of teriparatide.

Age Factors↗

Control of bleeding in patients with haemophilia A with inhibitors: a systematic review.

This paper reports a systematic review of the best available evidence of clinical effectiveness in the treatment of acute bleeding in haemophilia A patients with inhibitors. Because of the lack of randomized controlled trials (RCTs) on this topic, broad inclusion criteria with regard to study design were applied in order to assess the best available evidence for each intervention. Because of the clinical and methodological heterogeneity of the evidence, it was not appropriate to pool data across studies; instead, data were synthesized using tabulation and qualitative narrative assessment. No evidence was found to support the use of high-dose factor VIII (FVIII) in bleeding episodes. However in surgery it was found to be highly successful (100%) for low-titre, low-responding inhibitors although not reliable for high-responding inhibitors. Porcine FVIII (pFVIII) was effective in the control of severe bleeding episodes with high-titre or high-responding inhibitors (100%) and in 60-90% of surgical procedures. Activated prothrombin complex concentrates (APCCs) appear to be more effective than prothrombin complex concentrates (PCCs) in the control of mild to severe bleeding episodes. There was no good evidence for the use of PCCs in surgery. APCCs controlled bleeding in approximately 90% of surgical episodes. Recombinant factor VIIa (rFVIIa) controlled 70-100% of mild to severe bleeding episodes with high-responding inhibitors, and achieved better results when used early. It was effective in 60-100% of surgical episodes. Doses varied from study to study, and side-effects from mild to infrequent but serious adverse events were reported. The quality of the evidence is variable. Limited evidence relating to other treatment options is also included in the review.

Acute Disease↗

The implications of contact with the mentor for preregistration nursing and midwifery students.

AIM OF THE PAPER: To examine the extent to which preregistration nursing and midwifery students have contact with their named mentor, and the implications of this. BACKGROUND/RATIONALE: Mentorship has an important part to play in enabling preregistration nursing and midwifery students to gain the maximum benefit from clinical placements. Previous research has indicated that the benefits of mentorship to learners are related to the number of occasions on which the student and mentor work together. DESIGN/METHODS: A research project commissioned by the Sheffield and North Trent College of Nursing and Midwifery (now the University of Sheffield School of Nursing and Midwifery) provided an opportunity to examine the extent to which their named mentors were available to Project 2000 students, and the implications of this. Students and their named mentors were asked to keep an activity diary for 1 week. The main objective was to collect activity data to inform an analysis of the costs and benefits of clinical placements to service providers. This cost-benefit study has been published elsewhere. However, the data also cast light on the extent to which mentors were available to students, and the implications of this, and it is these findings which are presented here. RESULTS/FINDINGS: Students frequently worked shifts without their named mentors even though unrostered students often worked weekends, evening and night shifts in order to maximize time spent with their mentors. In the mentor's absence, other members of staff covered for some of their activities (in particular, direct and indirect supervision of students). However, students whose named mentors were absent spent significantly less time than other students working with a qualified member of staff as a partner in giving care. CONCLUSIONS: It is suggested that the extent to which named mentors are unavailable to Project 2000 students may be detrimental to the education and professional development of those students.

Education, Nursing↗

Practical considerations in case study research: the relationship between methodology and process.

This paper explores the extent to which the design of a research study is influenced by pragmatic as well as theoretical considerations by describing the authors' experience of conducting multiple case studies in the context of a policy-orientated research project. The case studies in question formed part of a collaborative project exploring the development of innovative roles in nursing and the professions allied to medicine. The researchers adopted Yin's approach to the conduct of multiple case studies to explore issues relating to the effectiveness of new roles, their resource implications and educational issues surrounding their development. They address the fact that methodological decisions have practical implications and also explore the effects of practical and ethical issues on research design. Three purposively selected acute National Health Service Trust hospitals in England formed the case study sites for the work recorded in this paper. In each Trust, three nursing roles were selected, making nine cases for study. A variety of data collection strategies were used including semi-structured interviews with post-holders and other stakeholders (n = 51), non-participant observation of meetings, collection of audit, financial and statistical data and review of relevant documentation. This paper describes some of the dilemmas which arose during the course of the study, the rationale for methodological decisions taken to resolve these dilemmas and the steps taken to enhance rigour. In particular, the authors discuss the problems associated with obtaining informed consent in the context of qualitative research and with member validation of transcripts in a context where confidentiality was crucial. The decision to present findings thematically rather than as individual cases is justified both in terms of the nature and purpose of the research and in relation to the particular importance of anonymity and confidentiality in this study. Finally, the degree of reciprocity between researcher and researched is discussed.

Attitude of Health Personnel↗

Should service providers be paid for providing pre-registration clinical placements?

The authors have argued elsewhere that second- and third-year student nurses and midwives on ward-based clinical placements make a service contribution which is of significant value to the service provider. The value of the service contribution made by students in community-based clinical placements is lower, not least because such placements cannot free staff time in the same way as on the wards, and thus the presence of students appears to form a cost to the service provider. It is clear that there is no case for introducing a system of payments for ward-based placements, but in community-based placements the position is less obvious. The argument hinges upon the perceived value to the service provider of the qualitative benefits associated with the presence of students on placement. Other studies have suggested that these benefits are such as to outweigh the associated costs. Because the presence of students on clinical placement is associated with both costs and benefits, efforts should be made to ensure that both ward-based and community-based placements are distributed as fairly as possible between locations so that no one location is unduly advantaged or disadvantaged by the number of students which it receives.

Accreditation↗