Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy (sensitivity and specificity) of the clinical variables assessed with the score form.
研究概览
简要总结
What combination of ≤ 6 clinical variables will give the highest specificity for indicating significant shoulder injuries (fractures or dislocations) with a set sensitivity of ≥ 97%?
Although shoulder trauma is a common injury, there is no clinical decision rule to determine the necessity for radiography for these traumas. With this trial the investigators aim to develop such a rule to reduce the amount of radiographs without missing any significant injuries.
The primary objective is to compose a set of clinical diagnostic criteria predictive of shoulder fractures or dislocations that would reduce the amount of radiographs without missing any significant injuries. A second objective is to determine if the clinical decision rule is applicable for triage use.
详细描述
The CASH (Clavicle-AC-Joint-Sub-capital-Humerus) trial is designed as a cross sectional interobserver study. It will randomize between first examiner of the patient to determine applicability for triage use and use a list of 19 criteria to determine a clinical decision rule for significant shoulder injuries.
Method/intervention After admittance to the ED, all consecutive shoulder injury patients will be assessed for eligibility in the study. After informed consent is given, the patient will be randomized for first observer (ED physician or triage nurse) to be examined, which means they will be assessed in duplo.
The patient will be examined by means of a score form, which contains 19 different diagnostic criteria. The criteria are grouped: anamnesis, inspection, palpation and pain/range of motion(ROM). After completing the list, patients will get a full set of shoulder x-rays: shoulder AP- and axial-view, and clavicle AP and 30' cranio-caudal view.
The trial participation for the patient will be completed at this point and final diagnosis and treatment are provided by the ED physician according to his/her own findings and interpretation of the radiographs. For the study, the radiographs will be reassessed by one consultant radiologist specialized in skeletal trauma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Aged18-65 years
- •Trauma <48h
排除标准
- •Any prior ipsilateral shoulder surgery.
- •Any diseases of the bones potentially influencing fracturability (osteogenesis imperfecta, osteoporosis, achondroplasia, M. Kahler, chronic (> 1yr) prednisone use > 5mg)
- •Any shoulder injury as part of a multi-trauma or high energy trauma (HET) with distractible injuries
- •Any condition that will influence the perception of pain (e.g. alcohol intoxication, psychiatric problems, mental retardation)
研究组 & 干预措施
MD as first examiner
Patients will be examined according to a standardized physical examination item list
干预措施: Standard diagnostic item list (Other)
Triage nurse as first examiner
Patients will be examined according to a standardized physical examination item list
干预措施: Standard diagnostic item list (Other)
结局指标
主要结局
Diagnostic accuracy (sensitivity and specificity) of the clinical variables assessed with the score form.
时间窗: An average of 12 to 18 months
次要结局
- Interobserver agreement for each clinical variable between both observers determined with the Cohen's kappa coefficient(An average of 12 to 18 months)
研究者
K. Rijsbergen
Research intern
Zaans Medisch Centrum