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临床试验/NCT02300428
NCT02300428已完成不适用

Health Economics of the Use of Ferrous Iron Salts in Primary Care in the UK.

dora pereira1 个研究点 分布在 1 个国家目标入组 406,902 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
406,902
试验地点
1
主要终点
Prescription rate

研究概览

简要总结

Iron deficiency anaemia (IDA) affects approximately 4.7 million of people in the UK, with children and pre-menopausal women being at higher risk (1). Each year more than 6.8 million prescriptions for oral iron are filled in England alone (NHS Information Centre data). However, gastrointestinal symptoms limit adherence in 10-30% of otherwise healthy patients (2-4) and in up to 50% of patients with gastrointestinal disorders (5). Simple ferrous iron salts constitute the vast majority of currently prescribed oral iron because these are cheap and well absorbed. However, they are also poorly tolerated and thus, we believe, are expensive to the NHS.

Funded by the Medical Research Council, we have developed an alternative oral iron supplement, that we name IHAT (iron hydroxide adipate tartrate), as an efficacious therapy for IDA with minimal side-effects.

In the study proposed here we aim to assess the total health cost associated with current oral iron supplements and, hence, define the clinical unmet need for alternative treatments. We will use Clinical Practice Research Datalink (CPRD) GOLD data to (i) estimate the pattern of prescribing to oral iron in primary care in the general population and (ii) develop a health economics model in pre-menopausal women. These data will provide evidence for the total health system costs associated with current oral iron treatment. Furthermore, this study will provide data from which the cost-effectiveness and total health system costs of alternative effective and treatments with minimal side-effects could be estimated.

详细描述

Our research objective is to gather evidence for the unmet clinical need for safe, low-side-effect oral iron in the UK.

To achieve this objective we aim to determine:

  1. Pattern of prescribing to oral iron in primary care in GP practices in England: estimate prescription rates, efficacy and intolerance of treatment with all forms of currently prescribed oral iron.
  2. Health economics of the use of ferrous iron salts in primary care: estimate patterns of individual response to treatment; determine the costs of ferrous iron (sulphate, fumarate and gluconate) therapy in pre-menopausal women in primary care, and develop a cost-effectiveness model for alternative treatments with minimal side-effects.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients prescribed oral iron in primary care practices included in the UK CPRD database

排除标准

  • 未提供

结局指标

主要结局

Prescription rate

时间窗: 12 months

number of prescriptions of iron supplements issued at the patient level in the year

Health Economics Modelling

时间窗: 10 years

In this analysis we will determine the following to parameterise the model that will be based on the cohort study over a 10 years period: i) Frequency of repeat oral iron prescriptions, ii) Number of hospital admissions, i) Incidence of gastrointestinal side-effects, ii) Treatment cessation rate iii) Haemoglobin changes The basis for the model will be the above data extracted from the CPRD, further informed by publicly available clinical trial data.

次要结局

  • Efficacy(12 months)
  • Gastrointestinal intolerance(12 months)

研究者

发起方
dora pereira
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

dora pereira

Senior Investigator Scientist

Medical Research Council

研究点 (1)

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