Agaplesion Bethesda Clinic, Geriatric Research Unit Ulm University, Ulm, Germany; Geriatric Center Ulm/Alb-Donau, Ulm, Germany.
Geriatric Center Ulm/Alb-Donau, Ulm, Germany; University Clinic Ulm, Department of Neurology, Ulm, Germany.
J Am Med Dir Assoc. 2019 Feb;20(2):138-146. doi: 10.1016/j.jamda.2018.11.008. Epub 2019 Jan 9.
When treating older adults, a main factor to consider is physical frailty. Because specific assessments in clinical trials are frequently lacking, critical appraisal of treatment evidence with respect to functional status is challenging. Our aim was to identify and categorize assessments for functional status given in clinical trials in older adults to allow for a retrospective characterization and indirect comparison of treatment evidence from these cohorts. We conducted 4 separate systematic reviews of randomized and nonrandomized controlled clinical trials in older people with hypertension, diabetes, depression, and dementia. All assessments identified that reflected functional status were analyzed. Assessments were categorized across 4 different functional status levels. These levels span from functionally not impaired, slightly impaired, significantly impaired, to severely impaired/disabled. If available from the literature, cut-offs for these 4 functioning levels were extracted. If not, or if the existing cut-offs did not match the predefined functional levels, cut-off points were defined by an expert group composed of geriatricians, pharmacists, pharmacologists, neurologists, psychiatrists, and epidemiologists using a patient-centered approach. We identified 51 instruments that included measures of functional status. Although some of the assessments had clearly defined cut-offs across our predefined categories, many others did not. In most cases, no cut-offs existed for slightly impaired or severely impaired older adults. Missing cut-offs or values to adjust were determined by the expert group and are presented as described. The functional status assessments that were identified and operationalized across 4 functional levels could now be used for a retrospective characterization of functional status in randomized controlled trials and observational studies. Allocated categories only serve as approximations and should be validated head-to-head in future studies. Moreover, as general standard, upcoming studies involving older adults should include and explicitly report functional impairment as a baseline characteristic of all participants enrolled.
在治疗老年人时，需要考虑的一个主要因素是身体虚弱。由于临床试验中通常缺乏特定的评估，因此评估治疗对功能状态的证据具有挑战性。我们的目的是确定并分类在老年人群中进行的临床试验中用于功能状态的评估，以便能够对这些队列的治疗证据进行回顾性描述和间接比较。我们对患有高血压、糖尿病、抑郁症和痴呆症的老年人进行了 4 项独立的随机和非随机对照临床试验的系统评价。分析了所有反映功能状态的评估。评估分为 4 个不同的功能状态级别。这些级别从功能未受损、轻度受损、明显受损到严重受损/残疾。如果文献中有这些 4 个功能级别可用，则提取其截止值。如果没有，或者现有截止值与预先定义的功能级别不匹配，则由一组老年病学家、药剂师、药理学家、神经病学家、精神科医生和流行病学家组成的专家组使用以患者为中心的方法定义截止值。我们确定了 51 种包含功能状态测量的工具。尽管其中一些评估在我们预先定义的类别中具有明确的截止值，但许多其他评估没有。在大多数情况下，轻度受损或严重受损的老年人没有截止值。缺失的截止值或需要调整的值由专家组确定，并按照描述呈现。跨 4 个功能级别确定和实施的功能状态评估现在可用于回顾性描述随机对照试验和观察性研究中的功能状态。分配的类别仅作为近似值，应在未来的研究中进行头对头验证。此外，作为一般标准，未来涉及老年人的研究应包括并明确报告所有入组参与者的功能障碍作为基线特征。
