Effectiveness and Cost-effectiveness of Outpatient Physiotherapy After Knee Replacement for Osteoarthritis: Study Protocol for a Randomised Controlled Trial

Background: Primary total knee replacement is a common operation that is performed to provide pain relief and restore functional ability. Inpatient physiotherapy is routinely provided after surgery to enhance recovery prior to hospital discharge. However, international variation exists in the provision of outpatient physiotherapy after hospital discharge. While evidence indicates that outpatient physiotherapy can improve short-term function, the longer term benefits are unknown. The aim of this randomised controlled trial is to evaluate the long-term clinical effectiveness and cost-effectiveness of a 6-week group-based outpatient physiotherapy intervention following knee replacement. Methods/design: Two hundred and fifty-six patients waiting for knee replacement because of osteoarthritis will be recruited from two orthopaedic centres. Participants randomised to the usual-care group (n = 128) will be given a booklet about exercise and referred for physiotherapy if deemed appropriate by the clinical care team. The intervention group (n = 128) will receive the same usual care and additionally be invited to attend a group-based outpatient physiotherapy class starting 6 weeks after surgery. The 1-hour class will be run on a weekly basis over 6 weeks and will involve task-orientated and individualised exercises. The primary outcome will be the Lower Extremity Functional Scale at 12 months post-operative. Secondary outcomes include: quality of life, knee pain and function, depression, anxiety and satisfaction. Data collection will be by questionnaire prior to surgery and 3, 6 and 12 months after surgery and will include a resource-use questionnaire to enable a trial-based economic evaluation. Trial participation and satisfaction with the classes will be evaluated through structured telephone interviews. The primary statistical and economic analyses will be conducted on an intention-to-treat basis with and without imputation of missing data. The primary economic result will estimate the incremental cost per quality-adjusted life year gained from this intervention from a National Health Services (NHS) and personal social services perspective. Discussion: This research aims to benefit patients and the NHS by providing evidence on the long-term effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement. If the intervention is found to be effective and cost-effective, implementation into clinical practice could lead to improvement in patients’ outcomes and improved health care resource efficiency.

Why do Women Sue?

Statistics published by the National Health Service Litigation Authority relating to ten years of maternity claims provoke a sharp intake of breath. The total value of these claims over the first decade of the 21st century was £3,117,649,888 (NHS Litigation Authority 2012). The United Kingdom is not the only country to witness an astronomical increase in the level of litigation relating to maternity services. As far afield as Saudi Arabia (Henary et al 2012) and the United States (Berkowitz 2011), reports are being published of the demands on maternity budgets as a result of dissatisfaction with care received during pregnancy, labour and birth. The papers referenced above attribute adverse outcomes to negligence, misdiagnosis, surgical blunders and inefficient administration. Berkowitz(2011:7) suggests that what is needed is wholesale and whole-hearted adoption of ‘…electronic fetal monitoring [EFM] certification for all staff working on their Labor and Delivery floor, protocols for managing common clinical scenarios, simulation drills for dealing with uncommon dangerous events, and pre-procedure checklists’. The NHS Litigation Authority (2012:5) recommends that Trusts ‘…engage with the risk management process at all levels; provide suitable learning and training; ensure appropriate supervision and support; have in place up-to-date protocols and guidance with which staff are familiar; learn lessons from claims’. It is relatively easy to ensure that staff are sent on fetal heart rate (FHR) training days (although whether use of EFM produces better outcomes has, of course, never been clearly demonstrated (Alfirevic et al 2013) and that protocols for managing events during labour and birth are drawn up and even put into practice. It’s uncertain, however, whether doing so will make the problem of maternity litigation go away. There is something ‘rotten in the state of Denmark’ that is fuelling women’s dissatisfaction and which ‘the system’ has not been able to get its head round.