■双膦酸盐是一类常用于治疗骨质疏松症的药物。阿仑膦酸盐被推荐作为一线治疗;然而,长期依从性(治疗依从性和持久性)较差.替代双膦酸盐是可用的,可以静脉给药,并已被证明可以改善长期依从性。然而,临床上最有效和最具成本效益的双膦酸盐替代方案仍不清楚.临床试验中最具成本效益的双膦酸盐可能不是患者日常临床实践中最具成本效益或可接受的。
■1.探索病人,临床医生和利益相关者的观点,与替代双膦酸盐相比,阿仑膦酸盐的经验和偏好。2.更新和完善2016年双膦酸盐的系统审查和成本效益分析,并估计进一步研究它们的好处的价值。3.开展利益相关者/共识参与,以确定重要的研究问题并进一步对研究重点进行排名。
■这项研究分两个阶段进行,阶段1A和1B并行,接下来是阶段2:•阶段1A-我们引起了患者和医疗保健经验,以了解他们对双膦酸盐治疗骨质疏松症的偏好。这是通过对定性研究进行系统审查和框架综合来进行的,其次是对参与者的半结构化定性访谈。•第1B阶段-我们更新并扩展了现有的卫生技术评估系统审查以及临床和成本效益模型,结合更全面的治疗效果回顾,安全,副作用,遵守和长期坚持。阶段2-我们确定了需要回答的关于双膦酸盐的有效性和可接受性的进一步研究问题并对其进行排序。
患者和医疗保健专业人员发现了坚持双膦酸盐药物治疗的许多挑战,平衡长期降低风险的潜力与坚持口服阿仑膦酸钠的工作。静脉用唑来膦酸盐治疗通常更可接受,这样的方案被认为更直接地参与,尽管部分服用阿仑膦酸钠的患者对目前的治疗感到满意.静脉注射唑来膦酸被发现是最有效的,与其他双膦酸盐相比,依从性更高,降低脆性骨折的风险。然而,口服双膦酸盐比静脉注射唑来膦酸盐更具成本效益,因为在医院使用唑来膦酸盐的成本较高.在设定研究重点时,包括患者和医疗保健专业人员的重要性得到认可。重要的研究领域与影响治疗选择和有效性的患者因素有关,如何优化长期护理和替代提供唑来膦酸的成本效益,非医院设置。
静脉唑来膦酸盐治疗通常更容易被患者接受,并且被发现是最有效的双膦酸盐,并且具有更大的依从性;然而,相对于口服阿仑膦酸盐的成本效益受到其较高的唑来膦酸盐医院管理成本的限制.
■需要进一步的研究来支持人们做出影响治疗选择的决定,有效性和最佳的长期护理,以及在非医院(社区)环境中静脉注射唑来膦酸盐的临床和成本效益。
■系统评价中包含的许多研究缺乏清晰度和局限性可能对一些与双膦酸盐效应相关的发现解释不足。
■本试验注册为ISRCTN10491361。
■该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:NIHR127550)资助,并在《卫生技术评估》中全文发表;卷。28号21.有关更多奖项信息,请参阅NIHR资助和奖励网站。
双膦酸盐是通常用于治疗骨质疏松症的药物治疗。阿仑膦酸盐是最常用的,是口服,每周在一周的特定时间,这可能是具有挑战性的。不到四分之一的人继续这种治疗超过2年。替代双膦酸盐是可用的,频率和管理方式各不相同。最可接受和最物有所值的方案尚不清楚。我们的目的是确定替代双膦酸盐与阿仑膦酸盐在预防骨折方面的有效性,以及是否以合理的财务成本降低了骨折风险。但患者可以接受。这项研究分两个阶段进行,阶段1A和1B并行,其次是阶段2:阶段1A:审查已发表的关于患者和医生观点的证据,关于不同双膦酸盐治疗方案的经验和偏好,随后是与患者和医疗保健专业人员的访谈。第1B阶段:关于双膦酸盐如何有效预防骨质疏松症引起的脆性骨折以及它们是否物有所值的现有研究的更新。阶段2:确定需要回答的关于双膦酸盐治疗的有效性和可接受性的问题。服用双膦酸盐药物通常需要患者付出很多努力,特别是服用阿仑膦酸盐片剂时。每年输注唑来膦酸盐治疗更可接受,与阿仑膦酸盐相比,更容易参与和最有效的治疗。然而,在医院使用唑来膦酸钠的费用使阿仑膦酸钠更物有所值.双膦酸盐能有效降低骨折风险,但是“继续治疗”,特别是阿仑膦酸盐片剂,仍然是一个挑战。每年输注唑来膦酸盐可提供可接受和有效的治疗。但是需要进一步的研究来支持患者和医疗保健专业人员做出关于各种治疗的决定,在医院外和社区施用唑来膦酸的好处和成本节约。
UNASSIGNED: Bisphosphonates are a class of medication commonly used to treat osteoporosis. Alendronate is recommended as the first-line treatment; however, long-term adherence (both treatment compliance and persistence) is poor. Alternative bisphosphonates are available, which can be given intravenously and have been shown to improve long-term adherence. However, the most clinically effective and cost-effective alternative
bisphosphonate regimen remains unclear. What is the most cost-effective bisphosphonate in clinical trials may not be the most cost-effective or acceptable to patients in everyday clinical practice.
UNASSIGNED: 1. Explore patient, clinician and stakeholder views, experiences and preferences of alendronate compared to alternative bisphosphonates. 2. Update and refine the 2016 systematic review and cost-effectiveness analysis of bisphosphonates, and estimate the value of further research into their benefits. 3. Undertake stakeholder/consensus engagement to identify important research questions and further rank research priorities.
UNASSIGNED: The
study was conducted in two stages, stages 1A and 1B in parallel, followed by stage 2: • Stage 1A - we elicited patient and healthcare experiences to understand their preferences of bisphosphonates for the treatment of osteoporosis. This was undertaken by performing a systematic review and framework synthesis of qualitative studies, followed by semistructured qualitative interviews with participants. • Stage 1B - we updated and expanded the existing Health Technology Assessment systematic review and clinical and cost-effectiveness model, incorporating a more comprehensive review of treatment efficacy, safety, side effects, compliance and long-term persistence. • Stage 2 - we identified and ranked further research questions that need to be answered about the effectiveness and acceptability of bisphosphonates.
UNASSIGNED: Patients and healthcare professionals identified a number of challenges in adhering to bisphosphonate medication, balancing the potential for long-term risk reduction against the work involved in adhering to oral alendronate. Intravenous zoledronate treatment was generally more acceptable, with such regimens perceived to be more straightforward to engage in, although a portion of patients taking alendronate were satisfied with their current treatment. Intravenous zoledronate was found to be the most effective, with higher adherence rates compared to the other bisphosphonates, for reducing the risk of fragility fracture. However, oral bisphosphonates are more cost-effective than intravenous zoledronate due to the high cost of zoledronate administration in hospital. The importance of including patients and healthcare professionals when setting research priorities is recognised. Important areas for research were related to patient factors influencing treatment selection and effectiveness, how to optimise long-term care and the cost-effectiveness of delivering zoledronate in an alternative, non-hospital setting.
UNASSIGNED: Intravenous zoledronate treatment was generally more acceptable to patients and found to be the most effective bisphosphonate and with greater adherence; however, the cost-effectiveness relative to oral alendronate is limited by its higher zoledronate hospital administration costs.
UNASSIGNED: Further research is needed to support people to make decisions influencing treatment selection, effectiveness and optimal long-term care, together with the clinical and cost-effectiveness of intravenous zoledronate administered in a non-hospital (community) setting.
UNASSIGNED: Lack of clarity and limitations in the many studies included in the systematic review may have under-interpreted some of the findings relating to effects of bisphosphonates.
UNASSIGNED: This
trial is registered as ISRCTN10491361.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127550) and is published in full in Health Technology Assessment; Vol. 28, No. 21. See the NIHR Funding and Awards website for further award information.
Bisphosphonates are drug treatments commonly used to treat osteoporosis. Alendronate is the most used and is taken by mouth, weekly at a specific time of the week, which can be challenging. Less than one in four people continue this treatment beyond 2 years. Alternative bisphosphonates are available, which vary in frequency and how they are administered. The most acceptable and best value-for-money regimen is unclear. Our aim was to determine how effective alternative bisphosphonates are compared to alendronate at preventing fractures and whether reduction in fracture risk was achieved at a reasonable financial cost, but acceptable to patients. The
study was conducted in two stages, stages 1A and 1B in parallel, followed by stage 2: Stage 1A: a review of the published evidence on patients’ and doctors’ views, experiences and preferences regarding different bisphosphonate treatment regimens, followed by interviews with patients and healthcare professionals. Stage 1B: an update of an existing
study on how effective bisphosphonates are in preventing fragility fractures caused by osteoporosis and whether they are good value for money. Stage 2: identification of questions that need to be answered about the effectiveness and acceptability of bisphosphonate treatments. Taking bisphosphonate medication often involves quite a lot of effort by patients, particularly when taking alendronate tablets. A yearly infusion of zoledronate treatment was more acceptable, easier to engage with and the most effective treatment compared to alendronate. However, the cost of administering zoledronate in hospital made alendronate better value for money. Bisphosphonates are effective in reducing the risk of fracture, but ‘continuing with treatment’, particularly alendronate tablets, remains a challenge. A yearly infusion of zoledronate offers an acceptable and effective treatment, but further research is needed to support patients and healthcare professionals in making decisions about the various treatments, benefits and cost savings of administering zoledronate outside of hospital and in the community.