Performance Improvement Program on Imaging II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Image quality as determined by The proportion of "yes" answers to Q1 and Q2 in the post-educational assessment II compared to the proportion of "yes" answers to Q1 and Q2 pre-educational assessment.
研究概览
简要总结
This study consists of a retrospective and a prospective part. For each part and in each of 5 clinics, one intraoperative postimplant image (lateral view) of 25 patients with pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two assessments in the retrospective part. a) before an educational intervention, b) after the educational intervention. The evaluated images at these two timepoints are identical. In the prospective part, the surgeons apply their new knowledge from the educational intervention. They perform the positioning of the patient during the intraoperative fluoroscopy and record the image according to the teaching material. One postimplant image of each patient will be used for the evaluation.
At all three timepoints of image assessment, a questionnaire with the same set of 7 criteria (Q1-Q7) for assessing the radiographs is used. The criteria refer to the content of the educational material.
详细描述
5 surgeons in 5 clinics will participate including a total of 125 prospective and 125 retrospective cases. This means 25+25 cases per clinic or 5+5 cases treated by each surgeon. The anonymized images of the surgeon's last 5 patients (retrospective part) and the pseudonymized images of the next 5 patients meeting the eligibility criteria (prospective part) will be assessed. Patients are eligible if they are at least 18 years old, have an AO 31-A1, A2 or A3 fracture and were treated with either a Proximal Femoral nail Antirotation (PFNA), a PFNA- II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN).
Individually, the 5 surgeons per clinic review the 25 postimplant intraoperative lateral images filed for 5 retrospective cases using a set of predefined criteria.
After this first assessment of retrospective cases, the group watches a video and a poster and has one hour of time to discuss it. The group reviews the 25 cases from the pre-education step again within a period of maximum 5 days. The data are analyzed at AO Clinical Investigation and Documentation (AOCID) and provided to the surgeons for data review meeting where they agree on areas for improvement and set target goals for the prospective series. For the whole period of the second assessment and the prospective series, the poster is placed in the area of the operating room.
After patient information/consent, eligible patients are included into the prospective part of the study and treated with either an intramedullary nail or a DHS. During the surgery, the surgeons use the newly achieved knowledge to record images.
In the next step, the 5 surgeons per clinic review individually 25 postimplant intraoperative lateral images of 5 prospective cases using the same set of predefined criteria. The data are analyzed at AOCID and review by the Imaging Working Group of AO Education.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Diagnosis of a pertrochanteric femoral fracture (AO 31-A1, A2, A3)
- •Surgical treatment with either a Proximal Femoral Nail Antirotation (PFNA), a PFNA-II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN)
- •For the prospective part of the study:
- •Informed consent obtained, i.e.:
- •Ability to understand the content of the patient information/Informed Consent Form
- •Willingness to allow the use of health-related data (images) according to the Clinical Investigation Plan (CIP)
- •Signed and dated Ethics Committee (EC)/Institutional Review Board (IRB) approved written informed consent
排除标准
- •For the prospective part of the study: - Mentally handicapped patients or patients with dementia that are not able to understand the content patient information/Informed Consent Form
结局指标
主要结局
Image quality as determined by The proportion of "yes" answers to Q1 and Q2 in the post-educational assessment II compared to the proportion of "yes" answers to Q1 and Q2 pre-educational assessment.
时间窗: 6 months
次要结局
- Interrater agreement between pre-educational and post-educational assessment of surgery's quality (Q3-Q7)(6 months)
- Interrater agreement between pre-educational and post-educational assessment of image quality (Q1-Q2)(6 months)
- Proportion of images that are rated as "not assessable" (Q3-Q7)(6 months)
- Proportion of "Quality of reduction and surgery" criteria with the best possible assessment (yes/optimal) (Q3-Q7)(6 months)
- Surgeons' experience (years and professional level)(6 months)
- Surgeons practice (average number of hip surgeries per month)(6 months)
- Self-assessment gap score(6 months)