Abstract：
UNASSIGNED: An objective, physiological measurement taken using a medical device may reduce the incidence of pressure ulcers through earlier detection of problems signs before visual signs appear. Research in this field is hampered by variations in clinical practice and patient-level confounders.
UNASSIGNED: The authors outline key considerations for designing a protocol for a study to assess the efficacy and safety of a prognostic medical device in reducing pressure ulcer incidence in a hospital, including comparators, randomisation, sample size, ethics and practical issues.
UNASSIGNED: Key issues relating to methodology and ethics are considered alongside a theoretical protocol, which could support future researchers in wound care trials.
UNASSIGNED: A prospective, three-armed, multi-centre, stratified cluster-randomised controlled trial is proposed. The third arm is recommended as it is expected that patients will need to be moved for the medical device to be used and repositioning is a preventive strategy. A minimum of 16 200 patients in 33 wards would needed to be recruited to achieve statistical significance. Ethical considerations in terms of consent or assent need to be considered.
UNASSIGNED: The hypothetical study designed to evaluate the effectiveness of a diagnostic or prognostic medical device in reducing pressure ulcer incidence in secondary care, while accounting for biases, would require large sample sizes and involves risks of inter-operator and inter-device reliability, heterogeneity of users and the vague clinical interpretation of device results. Robust research in this field has the potential to influence or change policy and practice relating to the prevention of pressure ulcers in secondary care.
UNASSIGNED: The authors outline key considerations for designing a protocol for a study to assess the efficacy and safety of a prognostic medical device in reducing pressure ulcer incidence in a hospital, including comparators, randomisation, sample size, ethics and practical issues.
UNASSIGNED: Key issues relating to methodology and ethics are considered alongside a theoretical protocol, which could support future researchers in wound care trials.
UNASSIGNED: A prospective, three-armed, multi-centre, stratified cluster-randomised controlled trial is proposed. The third arm is recommended as it is expected that patients will need to be moved for the medical device to be used and repositioning is a preventive strategy. A minimum of 16 200 patients in 33 wards would needed to be recruited to achieve statistical significance. Ethical considerations in terms of consent or assent need to be considered.
UNASSIGNED: The hypothetical study designed to evaluate the effectiveness of a diagnostic or prognostic medical device in reducing pressure ulcer incidence in secondary care, while accounting for biases, would require large sample sizes and involves risks of inter-operator and inter-device reliability, heterogeneity of users and the vague clinical interpretation of device results. Robust research in this field has the potential to influence or change policy and practice relating to the prevention of pressure ulcers in secondary care.
摘要：
■一个目标，使用医疗设备进行的生理测量可以通过在视觉迹象出现之前早期检测到问题迹象来降低压疮的发生率。该领域的研究受到临床实践和患者水平混杂因素的影响。
■作者概述了设计一项研究方案的关键考虑因素，以评估预后医疗设备在降低医院压疮发生率方面的有效性和安全性。包括比较器，随机化，样本量,道德和实际问题。
■与方法和道德相关的关键问题与理论协议一起考虑，这可以支持未来的研究人员进行伤口护理试验。
■预期，三臂，多中心,提出了分层整群随机对照试验。建议使用第三臂，因为预计需要移动患者以使用医疗设备，并且重新定位是一种预防策略。至少需要招募33个病房的16200名患者才能达到统计学意义。需要考虑同意或同意方面的道德考虑。
■旨在评估诊断或预后医疗设备在降低二级保健中的压疮发生率方面的有效性的假设研究，在考虑偏见的同时，将需要大样本量，并涉及运营商间和设备间可靠性的风险，用户的异质性和设备结果的模糊临床解释。该领域的强大研究有可能影响或改变与预防二级保健中的压疮有关的政策和实践。
■作者概述了设计一项研究方案的关键考虑因素，以评估预后医疗设备在降低医院压疮发生率方面的有效性和安全性。包括比较器，随机化，样本量,道德和实际问题。
■与方法和道德相关的关键问题与理论协议一起考虑，这可以支持未来的研究人员进行伤口护理试验。
■预期，三臂，多中心,提出了分层整群随机对照试验。建议使用第三臂，因为预计需要移动患者以使用医疗设备，并且重新定位是一种预防策略。至少需要招募33个病房的16200名患者才能达到统计学意义。需要考虑同意或同意方面的道德考虑。
■旨在评估诊断或预后医疗设备在降低二级保健中的压疮发生率方面的有效性的假设研究，在考虑偏见的同时，将需要大样本量，并涉及运营商间和设备间可靠性的风险，用户的异质性和设备结果的模糊临床解释。该领域的强大研究有可能影响或改变与预防二级保健中的压疮有关的政策和实践。
