By Paul Williams1, David J Beard2 and Navin Verghese3
1Clinical Director Trauma, Orthopaedics and Spinal Surgery, Swansea Bay University Health Board (SBUHB)
2Professor of Musculoskeletal & Surgical Science, University of Oxford & Swansea Bay University Health Board (SBUHB)
3Clinical Lead for Spinal Surgery, Swansea Bay University Health Board (SBUHB)
Published 08 October 2020
Whilst there are some laudable successes from the COVID-19 period, it has also highlighted and accentuated many vulnerable aspects of our healthcare system. The waiting list and delay for elective surgery is one such example. In orthopaedics the waiting time for routine elective orthopaedic surgery, once deemed necessary for an individual patient, has consistently drawn interest and comment over several decades, usually for the wrong reasons. Ironically, the existence of any prolonged delay for orthopaedic surgery seems at odds with the drive for evidence based healthcare provision as hip and knee arthroplasty have been repeatedly shown to be some of the most cost effective and low risk surgical interventions within our health system today1,2. A rationale to the apparently tolerant approach to delay and under resourcing for orthopaedic services does exist. Whilst frustrating for many, the absence of any life threatening aspect or perceived serious detriment to a patient suffering from osteoarthritis (OA) or in need of arthroplasty is a key factor. Often, non-trauma elective orthopaedic operations are considered as 'non-essential' as it is pre-supposed the potential for harm due to delay is low. In this editorial we challenge this position on the basis of obsolete data and a rapidly changing elective surgery landscape. We also make a plea to address some of the shortcomings that may be contributing to potential assumption, misinterpretation, and ultimately incorrect policy.
There is no question waiting lists have continued to increase exponentially. The COVID-19 pandemic has significantly reduced a previously over-burdened and under provided capacity even further resulting in increased scrutiny and prioritisation comparisons within and across surgical specialities. Elective orthopaedic and spinal surgery have been dismissed even further into the shadows. Prior to COVID-19 the waiting lists for orthopaedic surgery (in Wales particularly) had soared. In England, which has less of a resource problem than Wales, the number on the T&O waiting list at the end of December 2019 was 526,000 (either for clinic or surgery appointments) and this was the highest level in recent years, of this number just over 100,000 patients had been on a T&O waiting list for over 18 weeks - again a record level for England3. The total waiting list number in England has now grown to 540,000, and those waiting over 18 weeks has tripled to 302,426 (as at August 2020). Organisations such as Versus Arthritis are highlighting this issue4. In SBUHB alone prior to the pandemic there were more than 1,500 patients that had waited in excess of a year for elective orthopaedic and spinal surgery with more than 400 waiting in excess of two years.
With such a backdrop there is real concern that such waits for surgery could do patient harm and it is ethical to explore any underpinning assumptions and the evidence for such a case. This includes; how the decision to refer patients for operation is made; what should be measured to indicate change or deterioration; what evidence exists to show waiting has a deleterious effect on this population; and what can be implemented to offset any potential negative effects. Lastly, it is important to investigate and set any findings against the different health provision/healthcare domains; 1. Clinical and Patient, 2. Legal aspects and litigation, 3. Service provision and resources.
Decision to operate
The placing of patients on the waiting list for orthopaedic surgery has clear implications for the magnitude of the waiting list, especially at times of limited resource with the concept of 'prudent healthcare' well accepted. There have been several recent studies of large datasets demonstrating how the capacity to benefit from the operation can be used to guide decision making for referral to surgeons and ultimately placement on a surgery waiting list. Assuming there is a temporal deterioration in pain and function over time these PROMS based instruments and scoring tools can be used to indicate thresholds for intervention and how outcome can be negatively affected if status is allowed to deteriorate. There is evidence that leaving the patient to deteriorate for too long (at least in terms of pain/functional deterioration, if not time) negatively impacts on the potential for good outcome5,6.
Added to this is a lack of standardisation on what levels of incapacity dictate being placed on a waiting list, a lack of transparency of the reasoning for doing so and the potential to 'game' the process to obtain early intervention. Some clinicians and patients can even pre-empt future status to account for the excessive waiting lists (“I’ll put you on it now as by the time you will need it the time will be about right”). Far from being ethically questionable (as patient need is being serviced in a genuine manner) this adds further complexity to understanding the true effects of orthopaedic waiting lists. Finally, the increasingly diverging position of public (excessive waiting lists) versus private health provision (no waiting time) adds further to the complexity. Scoring tools such as PROMS, published guidelines and referral to treat target times will all impact the decision to operate. One would like to expect decisions are made upon need but such selection and prioritisation is also not without contention7.
Deterioration, doing harm or threat to life
In considering the implications of waiting for elective orthopaedic surgery, (in this case mainly hip/knee arthroplasty, but not excluding spinal surgery), there is no question that some hierarchy exists. Compared to surgical interventions for more immediate threat such as tumour, aneurysm, transplant, or cardiac surgery, any delay is likely to have a relatively less serious consequence and usually does not include death. The threat from the immediate pathology outside oncology, (usually OA), centres around increased pain and further dysfunction and this is well established. What is not clear is whether the new world of excessive waiting and cancellation has increased the threat of poor outcome or has brought in new lines of threat, including serious pathology secondary to the original musculoskeletal condition. It is well known that any co-existing pathology will contribute to health status8. Immediate investigation of this is warranted. We need to know the best methods of measuring deterioration, whether patients on an elective orthopaedic waiting list do truly experience detrimental effects and whether such effects are related to the duration of the wait. Finally, from a solution perspective, we need to know what policies should be employed to reduce, obviate or legislate against any negative effects.
1. How to measure deterioration
Measurement science in orthopaedics is well developed and there are many instruments seemingly capable of demonstrating change in status over time. To have value these instruments, such as PROMS and other similar scoring tools, need to be considered alongside experimentally calculated clinical significances of Minimally Important Change (MIC) and Minimal Important (Clinical) Differences (MID / MICD) especially when looking at group comparisons9. That is to say, how is a change in score reflected clinically?
Clinical and radiological measures must not be underestimated and certainly have their place with no real substitute for the wealth of experience gained through years of surgical training and practice. However, because of a hierarchy of perceived importance to a patient, symptom and activity level assessments often take priority with these measures often taking second place or demoted to mechanistic questions.
There are some deficits in this measurement arena too. Firstly, there appears a near absence of information on co-morbidity and the effect of this on elective orthopaedic patients on a waiting list. Secondly, if a self-reported instrument is used it can be insufficiently responsive or precise to show small incremental changes in status associated with waiting list effects i.e. trends. Some PROM scores are especially prone to this due to the irregular pattern and variation in patient status over time and the inability to flag small signals10. When changes are small there are difficulties distinguishing real difference from error or noise11.
2. Evidence for detrimental effects
In exploring waiting times for orthopaedic surgery the body of evidence for detrimental effect is one of the most serious areas of concern. Considering how topical this subject has been over many years there is an unexpectedly poor level of quantity and quality of evidence for detrimental effects whilst on an orthopaedic waiting list. There are surprisingly few longitudinal datasets on which to base any conclusions. The summary message from the present evidence is also unforeseen and likely misleading for modern times.
Two of the best and most contemporary pieces of evidence, in the form of systematic review, are from Hoogeboom et al. 2018 and Morris et al. 2018. The former study found 15 studies which provided reliable data from which to conclude a position. There was evidence in both hip and knee replacement OA patients waiting for surgery that pain did not increase during a 180-day wait (six months). However, function was shown to deteriorate during this time. Whilst systematic review evidence is powerful it considers wait times at around six months to one-year maximum. In these unprecedented times some of the waits being discussed are five or six times this length of time (up to three years). There is no data on which to base any reasoning for delays of this magnitude12.
The review of Morris looking at 18 worthwhile studies in terms of Quality of Life (QoL) found the evidence less convincing. They found an inconsistency in reporting (possibly due to the longitudinal datasets becoming obsolete) hampering any interpretation and their final message was aimed at guiding the methodology for future data collection13. Both sets of work suffer from examination of the problem in a previous era and do not address the prolonged waits of today.
Other studies, (outside the UK), have provided evidence of deterioration with 69% of patients in the Australian system experiencing a decrease in HRQoL whilst waiting up to 6 months (again a much shorter time than the current climate had some deterioration)14. Hirvonen et al., documented that the evidence can be mixed for hip and knee replacement and waiting for treatment does not necessarily lead to deterioration of health outcomes but can still generate “certain disutility to patients, pain and anxieties while waiting”15.
Studies involving populations of patients with other previous pathology that ultimately requires elective orthopaedic surgery, such as meniscal damage, also support a picture of potential for deterioration16. One study examining ACL patients on a waiting list (for six months) showed considerable mental (51%) mental and physical deterioration (63%)17.
Perhaps more persuasive is a recent and seminal study out of Edinburgh of over 2,000 THRs and over 2,000 TKRs looking at the effect of co-morbidity such as COPD and peripheral vascular disease. 12% of all TKR 'waiters' and 19% of all THR 'waiters' had a score on the EQ-5D global health instrument of 'worse than death [WTD]'8. This is one of the few studies to address co-morbidity in waiting list patients.
Spinal surgery predominantly targets neurological compression causing radiculopathy and/or myelopathy and commonly shares resources with Orthopaedics. Consequently, RTT waiting times are frequently related. Neurological tissue has unpredictable and limited regenerative properties. Therefore, once the decision has been made to operate, the principle of spinal surgery is to perform surgical decompression in as timely a fashion as possible in order to minimise irreversible neurological harm, especially where there is evidence of objective deteriorating neurological deficit.
In the acute setting, delayed lumbar surgery is associated with poorer neurological outcomes including foot drop18, bladder and bowel dysfunction19. In the sub-acute and chronic settings, more relevant when considering increasing waiting lists, the evidence indicates that duration of symptoms prior to surgery ranging from 4 – 36 weeks breakpoints is associated with poorer outcomes related to pain relief20, motor function21 and return to work22. The cost effectiveness of early spinal surgery has also been demonstrated when comparing cost per QALY with prolonged conservative management23,24. Poorer outcomes are also associated with delayed semi-elective surgery for cervical myelopathy25 with potentially devastating consequences with permanent loss of spinal cord function.
3. Substantial deterioration and relationship with waiting duration
There is no evidence (found to date) on which to base a judgement call whether these detrimental effects are substantial or not. Furthermore, and perhaps most critically, no work could be found to show a clear relationship between status and waiting time on an elective orthopaedic waiting list. This should be interpreted as a lack of data problem rather than a non-problem. Anecdotally, there is agreement that the longer time patients wait for arthroplasty surgery, the more they will deteriorate – osteoarthritis is a progressive degenerate chronic condition. We also know that prolonged use of NSAIDS is associated with gastrointestinal bleeding and cardiac events. Many other forms of analgesia are associated with significant side effect profiles. Specific events however, that may be causatively attributable to the length of time a patient has waited on the in-patient list, such as peptic ulceration or a fracture adjacent to an ankylosed joint for example, are hard to prove and there is a lack of evidence based literature to define 'harm' by way of such metrics. Psychosocial and socioeconomic deterioration is assumed but again can be difficult to define and quantify objectively and are often overlooked by surgeons.
4. Optimisation and prioritisation
There is some work that has looked at optimisation of surgery timing in the wake of increased waiting times and limited resources. The recent Arthroplasty Candidacy Help Engine (ACHE) work of Price et al. (2020) has shown that there may well be a 'sweet spot' for listing and performing arthroplasty surgery. It gives little detail about deterioration over time owing to the cross sectional nature of the database (a problem with many interpretations for this area as already mentioned) but may be useful in guiding decision making at any time in the course of the disease6.
Similar issues around prioritisation have been encountered in Finland where it was found 73% of the waiting list population had co-morbidity. The co-morbidity was associated with reduced HRQoL and the recommendation was that these patients should be prioritised26.
Closer to home, the Scottish study of Scott et al. found that the co-morbidities in their sample contributed to the very poor HRQoL scores. Those patients had a much worse outcome at one year arthroplasty in terms of Oxford scores and satisfaction8. As a result some algorithms have since been designed to help with urgency or prioritisation27.
5. Can you improve while waiting?
There is evidence that some of the counter-measures available for arresting deterioration on an elective orthopaedic waiting list can be effective. For TKR a therapeutic education and functional re-adaptation (TEFR) programme was successful in terms of health-related quality of life (HRQL)28. A similar programme has been described by O’Brien and a randomised control trial to evaluate is currently ongoing29.
There will be implications of an extended waiting time for orthopaedic surgery but the scarcity of data, and the obsolete nature of any existing data, is far from helpful in making considered decisions or classifications. Robust data is not yet available to demonstrate the amplified negative effects of COVID-19 on waiting times for surgery and any sequelae of the now greatly extended wait which for most patients in Wales is at present at least an additional six months. Added to this poorly evidenced deterioration picture are complexities from the likely non-linear pattern of deterioration (both temporally and in magnitude). The ability to accurately identify and mark signals of change or transition compounds the difficulty. New data sets should always account for baseline variability and use standardised measures. Without accounting for baseline status optimisation or priority setting will be impossible. There are also theoretical displacement consequences of co-morbidity (not discussed in detail here) where patients with serious and developing co-morbidity have their orthopaedic condition downgraded in urgency to treat the co-morbid condition. The unprecedented waiting times for elective orthopaedics now in existence does need a fresh approach with new importance placed upon longitudinal changes in chronic conditions. Unfortunately, in the absence of mature datasets on temporal change, there is also an absence of reliable surrogate data on which to base or help resource planning.
In terms of legal or litigation issues, the above summary has shown that there is very little appropriate data on which to base any conclusions or predictions. The recent prioritisation guidelines issued by the Royal College of Surgeons, the British Orthopaedic Association (BOA) and various speciality societies have defined categories of clinical risk with expected timeframes for treatment30. These have not been previously readily available to the general public and the legal profession in terms of their ability to reference. The heterogeneous nature of the pre-COVID-19 waiting lists in Wales has resulted in many patients who were not 'formally categorised' at the decision to operate being the subject of validation exercises resulting in them being identified as within categories that should have had surgery a long time previously according to these new guidelines.
Since the publication of the NHS Plan of 2000 health care providers in England have been required to offer patients an appointment for the elective treatment within 18 weeks of referral with rewards and penalties for successful and unsuccessful performance. The legal profession may suggest that not meeting this target for an individual patient is tantamount to 'treating them with contempt'. Such prioritisation guidelines risk the possibility of front loading the waiting list with clinically 'more urgent' patients (Category 2 and 3, with 1 being emergency) to the detriment of category 4 patients. By default, this will effectively lead to rationing of resources on the basis of clinical need and the very real possibility that some patients will never come to the top of the waiting list. Ethically this raises significant concerns regarding equality. Geographically, there exists significant variation in the capacity available to provide for these different groups; for example, in Wales the lack of uptake of GIRFT recommendations towards 'hot' and 'cold' sites continue to impinge upon the ability to offer any sort of sustainable elective service. Politically, there are far reaching healthcare provision and ethos implications as patients are left with no alternative other than to look towards the private sector or accept that they have to live with their condition.
For the clinician it is a difficult arena and clinical autonomy must retain credence. For the patient it is highly frustrating and there will be concerns about serious mental health issues amongst other developing pathology. In terms of service provision, until there are robust longitudinal data sets documenting deterioration over the longer period, healthcare procurement decisions will be hampered. Cost effectiveness may also change with longer waiting times for surgery and this requires constant monitoring31.
- There is very little evidence overall in this area to support decision making or policy.
- Many of the databases are cross sectional with few longitudinal repeat measures.
- The 'waiting time' is a critical factor especially as there are no studies with such prolonged current waiting times in existence.
- The ongoing slide (increase) in waiting time is highlighted by the research profile and population characteristics of the existing portfolio of studies in this area. The previous context is out of date.
- The limited evidence that does exist shows a mixed picture and the studies which show minimal change in status have examined much shorter waits than today and can be misleading.
- Good outcome measures exist but may be insufficiently developed for exploring waiting list effects.
- There is a very strong argument and need for immediate prospective data collection on patients who are waiting for elective orthopaedic surgery in the current period.
- Daigle ME, Weinstein AM, Katz JN, Losina E. The cost-effectiveness of total joint arthroplasty: a systematic review of published literature. Best Pract Res Clin Rheumatol 2012;26(5):649-58.
- Dakin H, Gray A, Fitzpatrick R, Maclennan G, Murray D, Group KATT. Rationing of total knee replacement: a cost-effectiveness analysis on a large trial data set. BMJ Open. 2012;2(1):e000332.
- British Orthopaedic Association (BOA) (2019). BOA expresses growing concern over lengthening waiting times for patients. Available at: https://www.boa.ac.uk/resources/boa-expresses-growing-concern-over-lengthening-waiting-times-for-patients.html.
- Versus Arthritis (2020). Our pain can’t wait. Fix joint replacement waiting times. Available at: https://community.versusarthritis.org/discussion/51495/our-pain-can-t-wait-fix-joint-replacement-waiting-times.
- Dakin H, Eibich P, Beard D, Gray A, Price A. The use of patient-reported outcome measures to guide referral for hip and knee arthroplasty. Bone Joint J. 2020;102-B(7):950-8.
- Price AJ, Kang S, Cook JA, Dakin H, Blom A, Arden N, et al. The use of patient-reported outcome measures to guide referral for hip and knee arthroplasty. Bone Joint J. 2020;102-B(7):941-9.
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- Naylor JM, Hayen A, Davidson E, Hackett D, Harris IA, Kamalasena G, Mittal R. Minimal detectable change for mobility and patient-reported tools in people with osteoarthritis awaiting arthroplasty. BMC Musculoskelet Disord. 2014;15:235.
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- Hirvonen J, Tuominen U, Seitsalo S, Lehto M, Paavolainen P, Hietaniemi K, et al. The Effect of Waiting Time on Health-Related Quality of Life, Pain and Physical Function in Patients Awaiting Primary Total Hip Replacement: A Randomized Controlled Trial. Value Health. 2009;12:942-7.
- Abram SGF, Judge A, Beard DJ, Carr AJ, Price AJ. Long-term rates of knee arthroplasty in a cohort of 834 393 patients with a history of arthroscopic partial meniscectomy. Bone Joint J. 2019;101-B(9):1071-80.
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