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临床试验/NCT03573765
NCT03573765已完成不适用

The Role of Patient Factors, Surgical Factors and Hospital Factors Upon Patient Outcomes and NHS Costs in the Treatment of Upper Limb Musculoskeletal Conditions: Spatial and Iongitudinal Analysis of Routine Data

University of Oxford0 个研究点目标入组 8,308,821 人开始时间: 1998年4月6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
8,308,821
主要终点
Revision and reoperation

研究概览

简要总结

Surgery is a common treatment type for damaged joints, tendons and nerves in the upper limb where conservative measures are inappropriate or have failed. These conditions are common and result in significant levels of pain and functional disability. The investigators are conducting a broad ranging study of variation in the provision of surgical treatment and factors affecting outcomes after surgical treatment of upper limb conditions. This will be a population-based study of all patients undergoing surgical treatment funded by the National Health Service (NHS) of England over a nineteen-year period. This study will help to understand the factors associated with a poor outcome following surgery, which can be shared with patients considering treatment options. The investigators will also document current and future health service burden associated with commonly performed surgical procedures including complications and repeat operations.

详细描述

The investigators will conduct time series analyses, geospatial mapping and risk-factor association studies for both access to and outcomes of surgical treatments of the upper limbs. A large cohort of pseudonymised records will be extracted from the NHS Hospital Episode Statistics Admitted Patient Care database. Suitable patients will be identified based on a match to a specified list of International Classification of Diseases (ICD-10) and Office for Population Censuses and Surveys (OPCS-4) codes. Dates and cause of death will be linked from the Office for National Statistics (ONS) by NHS Digital.

Separate analyses will be conducted for different intervention types with detailed outcomes reporting for high volume procedures. Adults will be defined as those aged 18 years or older at the time of surgery. Children will be defined as those aged less than 18 years at surgery and only included in a limited number of analyses where relevant (e.g. trigger digit).

Key analyses:

  1. Baseline demographics by procedure type
  2. Procedure volume incidence trends
  • Time series analysis
  • Adjusted to standard population distributions
  • Geographical mapping including adjustment for sociodemographic indices including indices of deprivation
  1. Revision, reoperation and mortality rates:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Condition affecting one of:
  • All patients treated with surgery for any of the following:
  • Osteoarthritis
  • Inflammatory arthritis
  • Any other cause of arthropathy
  • Tendon tears
  • Peripheral neuropathy
  • Fractures and/or dislocations
  • Instability
  • Any arthroplasty surgery using a prosthesis

排除标准

  • Patients registering a "type 2 opt out" - withholding NHS data from research use.

结局指标

主要结局

Revision and reoperation

时间窗: 1998-2017

Estimated at annual increments and standardised lifetime risk

Treatment volume: time series

时间窗: 1998-2017

Crude and adjusted for population by age/sex

Treatment volume: geospatial patterns

时间窗: 1998-2017

Mapped according to residence and NHS organisation boundaries

次要结局

  • Complications(30, 45, 60, 90 days post surgery + 1 year and last recorded follow-up/censoring.)
  • Readmission to hospital(up to 30 days following surgery)
  • Healthcare related costs(up to 52 weeks from date of surgery)
  • Length of stay post surgery(up to 52 weeks from date of surgery)

研究者

申办方类型
Other
责任方
Sponsor

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