Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery
试验速览
- 阶段
- 不适用
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Completion of interviews (stage one)
研究概览
简要总结
People who undergo surgery, or develop intestinal obstruction will spend a period of time without normal bowel function. This might extend beyond the normal measures of passage of flatus or tolerance of diet. This study will take a three stage approach to develop a patient reported outcome measure for gastrointestinal recovery.
Stage 1: Qualitative interviews with 20-40 patients who have undergone major abdominal surgery, or conservatively managed intestinal obstruction. These interviews will identify key themes and ideas to develop the questionnaire.
Stage 2: Face validity testing of questionnaire with 20 patients, using the QQ-10 questionnaire to aid assessment. The questionnaire may be edited after this.
Stage 3: 250-500 patients will be asked to complete the questionnaire following surgery or treatment for intestinal obstruction. Basic demographics will also be collated. Item reduction and scale refinement will be undertaken using this dataset. This will provide a PROM of gastrointestinal recovery which is ready for validation.
详细描述
Gastrointestinal dysfunction is commonly seen after surgery, and also manifests itself in intestinal obstruction. During this time, the patient may experience a range of symptoms of acute intestinal failure, including loss of motility and absorption. These may resolve at different rates during the period of gastrointestinal recovery. Trials in the area have conflicting results, partly due to the selection of clinician reported unidimensional outcomes. There is a clear need for a patient reported outcome measure (PROM) to record gastrointestinal recovery.
Aims and Objectives
- To develop a PROM for gastrointestinal recovery.
- To identify a candidate long-list of items for inclusion in a PROM through semi-structured patient interviews, and test face validity with patients and an expert panel
- To develop a PROM using the approved long list
Methods This study will be conducted in three stages with reference to FDA (Food and Drug Administration) and ISOQoL (International Society for Quality of Life Research) guidelines.
Stage 1: Five centres will undertake purposive sampling to identify patients who have undergone major intraabdominal surgery (including gastrointestinal, urological, and gynaecological) and patients treated for intestinal obstruction. It is expected that 40-60 participants will undergo a semi-structured interview to identify important items related to recovery of gastrointestinal function in order to reach thematic saturation. Interviews will be transcribed and coded using a framework methodology. This will generate allow us to construct a prototype questionnaire with an initial pool of items.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Adult patients (aged 18+) admitted to hospital for one of the following reasons will be eligible to participate:
- •Undergoing major elective gastrointestinal surgery (e.g. colorectal resection, gastric resection, liver or pancreatic resection)
- •Emergency laparotomy for non-trauma indication
- •Patients undergoing intra-abdominal surgery for non-gastrointestinal indications e.g.cystoprostatectomy, prostatectomy, nephrectomy, hysterectomy, or oophorectomy.
- •With a diagnosis of intestinal obstruction (small or large bowel).
- •Participants are permitted to participate in another study or trial in addition to PRO-DIGI
排除标准
- •Non conversationaI standard of English
- •Unable to provide informed consent
结局指标
主要结局
Completion of interviews (stage one)
时间窗: Within one month of treatment
completions of interview by group 1
Completion of questionnaire (stage three)
时间窗: Within two weeks of treatment
completion of questionnaire by group 3
Completion of face validity assessment (stage two)
时间窗: Within one month of treatment
Assessment of face validity using the QQ-10 (Questionnaire quality-10 item) questionnaire by group 2
次要结局
未报告次要终点