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临床试验/NCT05723120
NCT05723120已完成不适用

Development and Validation of the PHYSIOSCORE to Assess the Complexity Level and Physiotherapy Care in Hospitalized Patients

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2018年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
2
主要终点
Respiratory variables

研究概览

简要总结

Abstract Background: Several medical scores have been developed to support clinical support and predict complications in hospitalized patients. However, there is no scale for physical therapy (PT) support.

Objetivo: To develop a scale to determine the level of complexity and PT support in hospitalized patients.

Methods: This cross-sectional study was performed in a tertiary hospital and developed in three distinctive phases: scale (PHYSIOSCORE) development, validation, and testing. The development phase was performed with ten senior PTs using the Delphi methodology. The validation and testing phases were performed by assessing 220 patients (n=110 in each phase). The reproducibility was evaluated by re-assessing 110 patients every five days until hospital discharge.

详细描述

Phase 1. Questionnaire validation construct. The committee comprised ten specialist physical therapists with more than ten years of experience in hospital care. The questionnaires were developed based on variables used in clinical practice. The committee agreed that the scale needed to meet four objectives7: (i) be composed of variables used by physical therapists working in the hospital; (ii) have valid content for hospitalized adult patients8; (iii) be viable9 (fast and easy to use); and (iv) have inter-examiner reliability.

In the first meeting, every committee member was asked to report relevant variables. After that, the committee was asked to classify each informed variable10-13 as unimportant, important, or essential for the physical therapy assessment to provide quality care to the patient during hospitalization. The validity of this construct was performed using the Delphi technique14,15, and the consensus was defined with a minimum percentage of at least 75% agreement as important or essential. Only the items that reached consensus were retained for the second round.

In the second round, the committee members were asked to re-evaluate each item and classify them on a 10-point numerical scale. Where the score 0 represented the item within the normal range and 5, 7, or 10 points, depending on the item analyzed, the condition that most deviated from normality and consequently would result in greater attention and greater complexity of physical therapy care (Appendix B). The consensus was defined with a minimum percentage of at least 75% agreement among the participants for each item.

The final version of the PHYSIOSCORE was composed of 106 items, divided into three domains: respiratory, imaging, and neuromuscular. For patients with spontaneous breathing or noninvasive mechanical ventilation, the PHYSIOSCORE consisted of six items: pulmonary function, pulmonary sound, need for airway clearance, peripheral oxygen saturation (SpO2), respiratory rate (f), and imaging examination. For patients on invasive mechanical ventilation, the PHYSIOSCORE was also composed of six items: pulmonary sound, PaO2/FiO2 ratio, patient-mechanical ventilator interaction, measurements of pulmonary mechanics, need for airway clearance, and imaging examination (Appendix C). The imaging examination was divided into four segments: pulmonary parenchyma, pleura, vascular plot, and expandability (Appendix D).

The neuromuscular evaluation consisted of six items: neuropsychological, muscle strength and tone, postural control, neuromotor coordination, and walking. (Appendix E).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Respiratory variables

时间窗: 3 years

"lung function", "breath sounds", "PaO2/FiO2", and "Chest X-ray"

neuromuscular variables

时间窗: 3 years

"muscle strength", "muscle tone" and "postural control"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alcino Costa Leme

Head Physiotherapist of Surgical ICU

University of Sao Paulo

研究点 (2)

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