Impact case study database

Shoulder pain is a common musculoskeletal condition associated with a high socioeconomic burden. Subacromial shoulder pain, which accounts for up to 70% of shoulder pain, has increasingly been treated with surgery over the past two decades, despite a lack of compelling evidence for clinical effectiveness or cost effectiveness. The University of Oxford team collaborated with the University of Bristol on a subsequent longitudinal study of use and cost of subacromial decompression surgery [A]; this investigated the use and cost of subacromial decompression in England over the last decade compared with other countries and explored how this related to the conduct and outcomes of randomised, placebo-controlled clinical trials e.g. [4]. They found that in England, the use of arthroscopic subacromial decompression (ASAD) increased by 91% from just over 15,000 procedures in 2007/8 to nearly 29,000 procedures in 2016/17 at a cost of approximately GBP125,000,000 per annum [A]. Despite this increase, publication of the CSAW trial results in November 2017 showed no difference in outcome between two surgical groups undergoing ASAD or placebo surgery for subacromial shoulder pain at any time point [3].

NHS England responded rapidly to the publication of the CSAW trial results. In 2018, the NHS England Evidence Based Intervention programme, which aims to reduce the number of inappropriate interventions on the NHS, placed ASAD for subacromial shoulder pain on a ‘procedures of limited value’ list for national Clinical Commissioning Groups, meaning ASAD would be performed only when specific criteria are met. The guidance for CCGs states “Recent research has indicated that in patients with pure subacromial impingement (with no other associated diagnoses such as rotator cuff tears, calcific tendinopathy and acromio-clavicular joint pain), non-operative management with a combination of exercise and physiotherapy is effective in the majority of cases.” [B p.35]. The CSAW trial [3] is cited as the primary source in the rationale for this recommendation. An updated patient information leaflet was produced (C).

Reduction of surgery rates and cost saving

Most of the increase in ASAD in England over the past two decades took place before 2011/12 [A]. The subsequent plateau in rates between 2011/12 to 2016/17, illustrated in the graph, could be attributed to raised awareness of the issue of treatment uncertainty and correlates with the CSAW trial registration in 2012, publication of the trial protocol in 2015 [3], presentation of the trial by Beard and Carr with the clinical community, and media attention [D].

Following publication of the CSAW trial results in 2017 and subsequent changes to NHS guidelines in 2018, annual rates of surgery in England have fallen 80% from 28,000 in 2016/17 to 5,720 in 2019/20 [A, E]. In 2016/2017, the median cost of an elective admission for ASAD alone was GBP4,476 [4]. This places ASAD costs at an estimated GBP129,000,000 in 2016/17 compared with GBP26,000,000 in 2019/20. The fall in ASAD rates following publication of the CSAW trial therefore represents a cost saving to the NHS of GBP103,000,000 per annum. A study published in 2020 found that surgery rates also fell by 29% in Scotland between 2014 and 2018 [F], and the authors identified this decline as “ *corresponding to the publication of epidemiological studies demonstrating a rise in [ASAD], and awareness of studies which questioned the benefit of [ASAD]*”, citing [1] and [4]. Meanwhile, the FIMPACT trial also found no clear evidence that ASAD is cost-effective [5].

The use of surgery has also been in decline in other countries, and this has been linked to CSAW trial data. For example, in Sweden rates of ASAD increased from approximately 80 per 100,000 in 2008/09 to approximately 150 per 100,000 in 2014/15 and subsequently decreased to 120 per 100,000 in 2018/19. According to the Professor of Orthopaedic Surgery at Lund University, Sweden: “This decrease was without doubt influenced by the awareness raised in the orthopaedic community of the limited evidence to support for efficacy of the procedure by first the publication of your trial protocol, and then the outcomes of the trial in The Lancet.” He continues: “ The Publication of the CSAW trial, and associated papers, has initiated a review within the Swedish Governmental Institutes of ‘National Board of Health and Welfare’, and the ‘Swedish Agency for Health Technology Assessment’…The result will be an update of the Swedish national clinical guidelines for patients with shoulder pain” [Gi]. The Director of the Whitlam Orthopaedic Research Centre reports changes in practice in response to the CSAW trial:

“I have been pleased to see the practice change that has occurred in sub-acromial decompression surgery worldwide. In my own country, rates of sub-acromial decompression have significantly declined and this has been seen in many countries worldwide, including the UK” [Gii].

Arthroscopic surgery is low risk, but some patients can experience infection, stiff shoulder, damage to blood vessels or nerves and ongoing pain [G]. Furthermore, analysis of mixed shoulder arthroscopic procedures suggests around 5 in 1,000 patients will suffer a significant or life threatening complication such as deep infection, pulmonary embolus or death. This small incidence of serious harms has been reduced as a result in the fall in surgery fates following publication of the CSAW trial. Indeed, a BMJ Rapid Response Review on Subacromial Decompression for Shoulder Pain published in 2019 in response to the CSAW and FIMPACT trials concluded, “ almost all informed patients would choose to avoid surgery because there is no benefit but there are harms and it is burdensome. Subacromial decompression surgery should not be routinely offered to patients with sub acromial shoulder pain” [H]. The review also highlights the burden of surgery on patients including a 2–10 hour outpatient stay following surgery, approximately two weeks off work during recovery and avoidance of activities such as overhead carrying for three months.

As noted by the Director of the Whitlam Orthopaedic Research Centre: “The impact on health that has largely stemmed from the C-SAW paper is not only felt in cost savings by avoiding unnecessary care, but it has also decreased the risks associated with unnecessary care” [Gii]. Similarly the President of the Canadian Orthopaedic Association and Research Chair in Evidence-Based Orthopaedics noted, “ *I firmly believe that the CSAW trial has decreased the risks associated with sub-acromial decompression, allowing patients to return to their usual activities with greater confidence and ease.*” [Giii]

In addition to the direct effect on shoulder pain care, the philosophy and approach to CSAW has resulted in many wider impacts on the scientific and public perception of surgical evaluation which remain ongoing. The CSAW trial led to significant media coverage, sparking public debate on the role of placebo surgery [I]. Together with epidemiological studies [1] it has also contributed to a step change in the orthopaedic community’s acceptance of evidence-based decisions for costly based interventions thereby maximising the effectiveness of hospital care budgets, for example in one account from Australia:

“I have found the C-SAW publication to be a recent example of one that has had a major impact not only in changing clinical practice, but in changing it for the better in that clinical practice is now much more reliant on the evidence available”

Director, Whitlam Orthopaedic Research Centre, Australia [Gii].

From being a rare and pharmacologically influenced design, the 3-way placebo surgical control trial pioneered in CSAW is now championed as a rigorous and appropriate method for fundamental assessment of surgical efficacy and treatment mechanisms in all surgical subspecialities. In 2018, the MRC and NIHR Methodology Research Programme jointly commissioned a workshop to set guidelines for use of placebo controls in surgical trials, led by Beard, leading to the ASPIRE guidelines to assist commissioners and researchers at a global level to design and conduct high quality placebo surgical trials [J]. Several surgical placebo control trials are now underway both in the UK and abroad, including the ACCURATE trial recruiting from Finland, Sweden and Norway. The Director of the Whitlam Centre wrote that “…the impact of the C-SAW study has been felt worldwide … in the change it has made to orthopaedic thinking by pushing it towards a greater understanding of and respect for the evidence” [Gii]. The President of the Canadian Orthopaedic Association summarised the impact of the University of Oxford research:

“Without doubt, the CSAW trial has had a global impact on research and clinical practice. This trial has empowered health care professionals and clinician scientists to pursue similar trials and sparked many discussions on the topic of placebo surgery within the orthopaedic field” [Giii].