Patients Experiences of Early Postoperative Cognition and Its Relation to Cognitive Decline and Inflammatory Responses: a Mixed Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Patients experiences of early postoperative cognitive recovery
研究概览
简要总结
The study has a mixed-methods design i.e. integration of qualitative and quantitative data within a single investigation. Participants included will be patients ≥60 years that are undergoing major elective joint replacement surgery (n=40) and their relative. Patient's experience of his/her cognition will be capture by interviews on postoperative day 13-16 during the follow-up visit and after 1 year. A relative will also be interviewed once on postoperative day 13-16. Cognitive function will be measured preoperatively and on postoperative day 13-16 using the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) test battery. Symptoms / discomfort will be measured pre- and postoperatively (on postoperative day 1 and 2 and at the follow up visit day 13-16) by the Swedish version of Quality of Recovery (SwQoR) and by a visual analogue scale assessing pain intensity. Biomarkers will also be collected at the same time points. The findings from the interviews will be sorted out depending on group stratification (no delayed neurocognitive recovery and delayed neurocognitive recovery). The qualitative and quantitative findings will be compared to seek for similarities and differences.
详细描述
Aim The aim of present study is therefore to explore patients' experiences of their early and late postoperative cognition after major orthopaedic surgery in relation to postoperative cognitive function assessed with validated neuropsychological tests, inflammatory signalling molecules and quality of postoperative recovery as well as to describe the relative's view of early postoperative cognition.
Study design A mixed-methods study i.e. inductive concurrent design where, the core component is qualitative and the supplemental component is quantitative with integration of qualitative and quantitative data within a single investigation will be undertaken to address the research questions.
Participants Patients Participants included will be patients undergoing major elective joint replacement surgery (n=40) at a university hospital in Sweden. The sample size is based on the mixed methods study design and the incidence of early cognitive decline at 1-2 weeks postoperatively of 17% -25%.
Exclusion criteria: a score on the mini-mental state examination (MMSE) at screening of ≤ 22 i.e. suspected dementia; < 60 years of age; suffering from a nervous system disease; taking tranquillisers or antidepressants; underwent a surgical procedure in the previous six months; or inability to read and speak Swedish; suffering from a severe visual or auditory disorder, alcoholism or drug dependence.
Relatives One close relatives (spouses or children with age ≥ 18 years) per patients will be asked to participate. Inclusion criteria for the relatives included identifying themselves as being a relative whom the patient included in the study and being able to take part in an interview in Swedish. The patient decide which relative that should be asked. If the relative do not accept to be included, the patient will not be excluded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing major elective joint replacement surgery
排除标准
- •a score on the mini-mental state examination (MMSE) at screening of ≤ 22 i.e. suspected dementia
- •age < 60 years
- •suffering from a nervous system disease
- •taking tranquillisers or antidepressants
- •underwent a surgical procedure in the previous six months
- •inability to read and speak Swedish
- •suffering from a severe visual or auditory disorder, alcoholism or drug dependence
结局指标
主要结局
Patients experiences of early postoperative cognitive recovery
时间窗: 13-16 days after surgery
The opening question t: "How do you yourself experience the time after the operation compared to before? " Probing questions were asked such as "What do you mean?" and "How would you describe that?" The informants will be encouraged to speak freely about the experience. An interview guide will be used to ensure covering issues such as cognition, memory loss, attention, mood and daily activity.
Quality of postoperative recovery
时间窗: 13-16 days after surgery
The patients' quality of recovery will be measured with the Swedish Quality of Recovery (SwQoR), which measure 24 different items related to symptoms/discomfort that appear postoperatively, such as pain, anxiety, sleep difficulties, dizziness, fatigue, returning to work or usual home activities. The items are rated on 11-point numerical scales ranging from 0, "none of the time", to 10, "all of the time". Reliability and validity tests have provided evidence that it is appropriate to use SwQoR in patients undergoing surgery
Cognitive function
时间窗: 13-16 days after surgery
Cognitive function will be measured preoperatively and on postoperative day 13-16 using the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) neuropsychological test battery The ISPOCD battery assesses cognitive performance using four different tests, providing seven variables for analysis, including Visual Verbal Learning Test, the Concept Shifting Test, the Stroop Colour-Word Test, the Letter-Digit Coding Test and has been validated in the perioperative setting for two decades. The tests will be administered in the same sequence at each test session by the same researcher following a standardized instruction manual in order to ensure as uniform a test situation as possible. The tests will be carried out in quiet rooms and only the patient and a researcher will be present.
Relatives experiences of patients early postoperative cognitive recovery
时间窗: 13-16 days after surgery
Opening question : "How would you describe your relative regarding being as they used to be, being themselves, before the operation compared to the time after surgery" Probing questions were asked such as "What do you mean?" and "How would you describe that?" The informants will be encouraged to speak freely about the experience. An interview guide will be used to ensure covering issues such as cognition, memory loss, attention, mood and daily activity.
次要结局
- Interleukin 1-beta (pg/mL)(13-16 days after surgery)
- Fractalkine (pg/mL)(13-16 days after surgery)
- C-reactive protein (mg/L)(13-16 days after surgery)
- Interleukin-6 (pg/mL)(13-16 days after surgery)
- HMGB-1 (μg/mL)(13-16 days after surgery)
- Experiences of late postoperative cognitive recovery(1 year after surgery)
- Interleukin-10 (pg/mL)(13-16 days after surgery)
- Postoperative pain(13-16 days after surgery)
研究者
Ulrica Nilsson
Professor
Karolinska Institutet