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首页> 外文期刊>Journal of Health Services Research & Policy >Adapting the randomized consent (Zelen) design for trials of behavioural interventions for chronic disease: feasibility study
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Adapting the randomized consent (Zelen) design for trials of behavioural interventions for chronic disease: feasibility study

机译：调整随机同意（Zelen）设计用于慢性疾病行为干预试验：可行性研究

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摘要

Objectives: Standard randomized controlled trials of interventions for chronic conditions that involve behavioural change, or that are highly desired by participants, are difficult to undertake because of problems with recruitment and contamination. Alternatives include cluster-randomized trials or pre-randomization designs such as the Zelen design. The aim here was to develop a pre-randomization design that would overcome ethical and methodological problems associated with the conventional Zelen design, and permit the rigorous evaluation of a complex package of care, involving physical therapy and behavioural changes, for patients with painful patello-femoral osteoarthritis of the knee joint. nnMethods: Eligible patients were first consented to a one-year observational study of their arthritis. They were subsequently randomized into intervention and control arms. Those in the intervention arm were then asked if they were willing to participate in a further study involving regular sessions with a physiotherapist. Those in the control arm were not told about this, but were followed up as agreed. nnResults: Eighty-seven patients consented to the observational study, 43 of whom were subsequently randomized to the intervention arm. All 43 consented to the intervention, although five of these did not receive the full package of care. Assessments were carried out at five months and one year on 82 patients, and concealment was satisfactorily maintained in the majority. nnConclusions: We conclude that this study design could potentially offer an acceptable compromise between the need for scientific rigour and the ethical imperative of fully informed consent in trials that involve behavioural change or interventions that patients might want to obtain.
机译：目标：由于招募和污染问题，难以进行涉及行为改变或参与者高度期望的慢性病干预措施的标准随机对照试验。备选方案包括群集随机试验或预随机设计，例如Zelen设计。目的是开发一种预先随机化的设计，该设计将克服与传统Zelen设计相关的伦理和方法问题，并允许对痛苦的pat骨症患者进行包括物理疗法和行为改变在内的复杂护理方案的严格评估。膝关节股骨骨关节炎。 nn方法：首先让符合条件的患者接受对关节炎的为期一年的观察性研究。随后，他们被随机分为干预和控制部门。然后询问干预部门的人员是否愿意参加进一步的研究，包括与物理治疗师定期会面。控制人员没有被告知这一点，但按照约定进行了跟进。结果：87例患者同意观察性研究，其中43例随后被随机分配至干预组。所有43人都同意干预，尽管其中有5人没有得到全部护理。对82例患者在5个月零一年时进行了评估，大多数患者的隐匿性令人满意。 nn结论：我们得出的结论是，在涉及行为改变或患者可能希望获得的干预的试验中，这项科学设计可能会在科学严谨性要求与充分知情同意的道德要求之间达成可接受的折衷。

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  • 来源
    《Journal of Health Services Research & Policy》 |2005年第4期|p.220-225|共6页
  • 作者

    Rona Campbell Tim Peters Clare Grant Brian Quilty and Paul Dieppe;

  • 作者单位

    Department of Social Medicine, University of Bristol, Bristol, UK;

    Academic Unit of Primary Health Care, Department of Community Based Medicine, University of Bristol, Bristol, UK;

    Academic Unit of Primary Health Care, Department of Community Based Medicine, University of Bristol, Bristol, UK;

    Department of Medicine (Rheumatology), University of Bristol, Bristol, UK;

    MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol, Bristol, UK;

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  • 正文语种 eng
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  • 关键词

    chronic disease;

    机译：慢性病;

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