Exactitud diagnóstica Del Instrumento Análisis de Carga de Trabajo Para Identificar Riesgos Laborales en Trabajadores Con Trastornos músculo esqueléticos de Extremidades Superiores Que se evalúan en la Asociación Chilena de Seguridad.
试验速览
- 阶段
- 不适用
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Occupational origin of upper limb musculoskeletal disorders
研究概览
简要总结
The aim of the study is to evaluate the diagnostic accuracy of an instrument (semi-structured interview) called Workload Analysis Instrument (WAI) (Análisis de Carga de Trabajo ACT), in detecting the presence of occupational risk in patients presenting an upper-limb musculoskeletal disorder. The test instrument was developed by Asociación Chilena de Seguridad (ACHS). This instrument will be applied to the worker when he or she visits the ACHS health care facility. The test administration is performed by an ergonomics specialist previously trained in WAI. WAI is the index test and the gold standard will be the Estudio de Puesto de Trabajo (EPT) resolution. The hypothesis of the study is that WAI is able to correctly label the occupational origin (rule in or rule out) of an upper-limb musculoskeletal disorder. Sensitivity, specificity and positive predictive value will be established.
详细描述
This is a cross sectional and prospective study where both the application of the index and reference instruments will be performed after the complete planning of the study.
Sample size was calculated assuming 90% sensitivity and 80% specificity of the WAI, based on experience with a similar instrument prior to WAI and on which WAI is built, which was used at the Hospital del Trabajador. For an absolute precision of 5%, the necessary sample size of people who actually have a work-related illness and those who do not actually have that origin should be 246. If 6% preciiosion is accepted that sample size should be 171.
Prevalence of ULMD qualified as from occupational origin is under 10% among patients who consult at the centers of the Metropolitan Region, according to the ACHS. Thus, the calculated final sample was approximately 1700 patients.
According to the project's budget, 900 applications of the WAI are to be planned.
The study will successively recruit patients: up to 246 true positives or 900 patients (whichever is reached first).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The care providers that administer the index test and the EPT assessment are not masked. However, the outcomes assesors of the EPT (gold standard) are masked to the results of the WAI (index test). The adminstrators of the WAI are unaware of the EPT result, as this evaluation is conducted after the application of the index test.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 and in a company affiliated to Asociación Chilena de Seguridad
- •Suspicion of occupational origin of upper limb musculoskeletal disorder and have a registered claim of occupational origin of reported disorder (DIEP form)
- •Disorder must be included in the following CIE-10 list: Trigger Finger ICD-10 code: M65.3; Flexor and extensor wrist tendinitis ICD-10 code: M65.8; Radial styloid tenosynovitis [de Quervain] ICD-10 ICD-10 code: M65.4; Carpal Tunnel Syndrome ICD-10 code: G56.0; Elbow Epitrocleitis ICD-10 code: M77.0; Epicondylitis ICD-10 code: M77.1; Shoulder tendinopathy of rotator cuff ICD-10 code: M75.1; Tendinitis bicipital ICD-10 code: M75.2; Subacromial bursitis ICD-10 code: M75.5
排除标准
- •Not consulting within the study recruitment timetable for a consecutive sample
- •Patients with physical limitations that preclude administering the instrument
- •Patients with prior diagnosis of the included disorder (see above)
研究组 & 干预措施
Study group
Intervention: Análisis de carga de trabajo (ACT)
干预措施: Análisis de carga de trabajo (ACT) (Diagnostic Test)
结局指标
主要结局
Occupational origin of upper limb musculoskeletal disorders
时间窗: Participants are only assessed once when they are interviewed with the WAI. Final outcomes are obtained without the participant.
Each patient´s disorder is classified as positive (occupational origin) or negative (non-occupational origin) by the index instrument and then by the gold standard. There are four possible main outcomes: true positive, true negative, false positive, false negative. Both the index instrument and the gold standard may yield a doubtful result.
次要结局
未报告次要终点