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临床试验/NCT03064334
NCT03064334已完成不适用

Patients' Views on Outcomes Following Total Knee Arthroplasty: a Focus-group Study

University of Salford1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Medium focus groups discussion to explore the patients experiance and functional recovery post -TKA.

研究概览

简要总结

In order to assess patients' concerns and other quality of life aspects, post-total knee arthroplasty (TKA) requires further assessment tools, more than controlled experiments testing defined isolated variables. Qualitative research offers useful methods to explicate the complexity and deeper meaning of patient experiences and outcomes post-TKA. Qualitative methods facilitate the collection of in-depth experiences and perceptions from individuals about a specific phenomenon which, in this case, is outcomes post-TKA. Specifically, a phenomenological approach allows for the collection of diverse and unique patient experiences and outcomes post-TKA .

The focus of this project is using focus groups to explore poorly understood areas, such as outcomes and experiences post-TKA, in order to generate useful findings and hypotheses.

详细描述

Knee osteoarthritis (OA) is a major cause of disability around the world; it is the most common chronic condition in primary care in the UK. By 2030 it is predicted to be the greatest cause of disability in the general population . An effective end-stage treatment for knee OA is knee-replacement surgery, which was first done in the 1970s and 1980s.

In England and Wales, the number of knee-replacement procedures recorded by the National Joint Registry in 2013 was 91,703, which represents an increase of 0.9 % over 2012. The data analysis by the National Joint Registry and the Office of National Statistics suggests that, by 2030, primary Total Knee Arthroplasty (TKA) will increase by 117% from the 2012 level. Subsequently, TKA revision surgeries are expected to increase incrementally by 332%. There is a similar estimation of demand for revision TKA surgeries in the United States; by 2030, they are expected to rise by 601% from the 2005 level. The United States estimation of primary TKA is for growth of 673% from the 2005 level, which is similar to England and Wales's upper-limit projections .

Post-TKA, 75-85% of patients report satisfaction with surgery outcomes, while the remaining 15-25% are dissatisfied .Total knee arthroplasty's success has traditionally been evaluated from the surgeon's perspective, e.g. the presence of surgical complications or implant survival. This is gradually changing to involve the patient in measuring health outcomes and decision-making processes. Patient-reported outcome measures (PROMs) have evolved to explore patient perspectives by monitoring the quality of care in health organizations and conducting clinical trial outcomes.

More than half of patients' early concerns post-total knee arthroplasty (TKA) are not considered in commonly used patient-reported outcome measures . This may support current medical outcomes evaluation post-TKA having implications that differ from the patient perspective. This may be explained by the dissatisfaction of some patients post-TKA. So, being more sensitive to patient experience assessment methods is required, rather than profession-driven tools.

Patients' experiences and their perceptions of current outcome measurements post-TKA are poorly understood. In order to explore this area qualitative methods are appropriate, as they facilitate the collection of in-depth experiences and perceptions of individuals about a specific phenomenon which, in this case, is outcomes post TKA. Specifically, a phenomenological approach allows for the collection of diverse and unique patient experiences and outcomes post-TKA.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who have undergone primary unilateral total knee arthroplasty within the last year.
  • Maximum post-operative achievement is between one and two years.
  • Patients can read and understand English, non-English speaking patients will be excluded from the study to avoid any language barrier.
  • Purposive sampling will be used to recruit the most relevant patients to answer the research questions such as;
  • mixed genders to explore gender-experience differences.
  • mixed work and retired to explore return to work barriers
  • patients with family support and patients living alone to explore the value of family support or home-care services
  • mixed educational levels to explore educational background effects.
  • So there will be no age, gender, social, work status or educational level limitations (Schwandt, 2001)

排除标准

  • There are possible complications or they present with other pathological conditions that might change recovery progression, they will be excluded to minimize confounding factors and their effects on patients' experiences and outcomes, such as:
  • They have undergone bilateral knee arthroplasty, unilateral knee revision surgery, post-traumatic or unicompartmental knee replacement.
  • They cannot read and understand English.
  • Their function is limited due to musculoskeletal involvements other than unilateral knee osteoarthritis.
  • They have been diagnosed with uncontrolled diabetes mellitus or blood pressure.
  • Post-TKR they are in pathological groups, such as having neurological disorders (stroke, Parkinson's disease etc.), haemophilia or psychological pathologies.
  • They are morbidly obese and have a body mass index (BMI) greater than
  • They have advanced osteoporosis or some other unstable chronic disease.
  • They have been diagnosed with peripheral vascular disease or an uncontrolled cardiac disease.
  • They present with major postoperative complications, such as infection, fracture, acute myocardial infarction, stroke, pulmonary embolism or deep-vein thrombosis.

结局指标

主要结局

Medium focus groups discussion to explore the patients experiance and functional recovery post -TKA.

时间窗: 60 -70 minute of total 120 minute of focus group discussion.

Qualitative methods in term of medium focus groups discussion will be used to explore the patients perceptions and experiences post-surgery. The focus groups will be facilitated by a focus-group expert and the researcher using open-ended questions in order to prompt free discussion to explore their experience and barrier post-TKA. All topics and questions covered will be suitable to discuss in a semi-public setting. All discussions will be recorded using electronic methods, in addition to field notes taken by both facilitator and researcher. Discussion guide: How was experience of Total Knee Arthroplasty (TKA), Functional improvements after TKA, What modifications have been made to compensate for that, What are the barrier, In the course of routine activities did the patients need help, Did the patients need family support, Were patients able return to work after TKA, (if not, why? what are the barriers

次要结局

  • Medium focus groups discussion to explore the quality of health service provide post -TKA(40 -50 minute of total 120 minute of focus group discussion.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bodor Bin sheeha

PhD student

University of Salford

研究点 (1)

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