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09 CHAPTER NINE CARE DESIGNED TO DELIVER BEST OUTCOMES

A. Volume and Outcomes

01 Patient expectations and the desire to deliver services close to home where possible are powerful reasons to build service configurations around patients.

02 But what patients need above all is high-quality care and the best possible outcomes. For highly specialised services, this may lead to a tension between the convenience of care close to home and the need to access very specialised care in a centre of excellence.

03 Improving quality of care will always be an important factor in developing proposals for service change, with patient safety coming first underpinned by research evidence and professional opinion. The link between volume and outcome is one aspect of quality that has been hotly debated. The relationship between volume and outcome has become a proxy for testing the arguments for and against specialisation. As the Scottish Parliament's Health Committee say in their 2005 Report on workforce planning;

'Increasing specialisation also appears to be at least partly responsible for a strong tendency towards centralisation within the Scottish NHS, particularly towards fewer, larger hospitals, resulting in the closure or downgrading of smaller units... There is evidence to suggest that for particular procedures increased specialisation works in terms of delivering better outcomes for patients.

...However, when questioned, witnesses before the Committee were unable to provide any detailed evidence to support the benefits of specialisation across the board.'

04 Those who argue that there is no relationship between volume and outcome, or that at best the relationship is unclear, most frequently quote the work published by the NHS Centre for Reviews and Dissemination at the University of York in 1997. In view of the importance of the issue, the Advisory Group asked Prof. Graham Teasdale (President of the Royal College of Physicians and Surgeons of Glasgow) and Prof. Gordon Murray (Professor of Medical Statistics, University of Edinburgh) to look again at the research evidence. The purpose was to re-review the research evidence, in particular taking account of papers published since 1997. In view of the time constraints placed by the timetable of the work of the Framework, it was accepted that the approach taken would be that of a conventional narrative review, not a formal, comprehensive systematic review.

05 In view of the importance of the work, the following section of the chapter sets out their findings in full. The report itself and full Appendices can be found at http://www.show.scot.nhs.uk/sehd/nationalframework

Background

06 In 1979 Luft and his colleagues focused attention on the possibility of a connection between an increased volume of clinical work and improved outcome. Since then, many further studies have reported this relationship. Nevertheless, certain issues identified by Luft remain to be clarified so that controversy, even conflict continues about the importance of the "complexity" of the condition and the risks of treatment, the existence of "thresholds" in the relationship, and the relative roles of individual practitioner versus unit or hospital volume. The need for risk stratification and the importance of using an appropriate index of outcome in investigating these issues has been recognised.

07 Much of the relevant information is derived from routine statistics. These allow little opportunity for risk stratification and provide outcome only as mortality. For interventions with a low risk of death, large numbers must be studied in order not to overlook an effect that could be important if the intervention is very common. For many interventions, mortality is not an appropriate index and other indicators of effectiveness, of quality of care and of patient satisfaction are required.

09 In 1997, the NHS Centre for Reviews and Dissemination at the University of York published a systematic review of the evidence available on the volume/outcome relationship in health care, based upon data available up to 1996 (Sowden et al 1997). Although they identified many studies that they considered suitable, that showed a volume/outcome association, in essence, the conclusion reached was that the bulk of research evidence was methodologically flawed and of little value in forming decisions about the planning of the delivery of health services. Since then, substantial additional literature has been published, including other comprehensive reviews.

09 The York Review (Sowden et al, 1997) reached three main conclusions on volume/outcome relationships:

• Case-mix: 'Most of the existing research, because it does not sufficiently take account of differences in case-mix, probably overestimates the impact of volume on the quality of care' (Summary Report, page 10).
• Causation: '...because none of the research indicates that increasing activity over time leads to improvements in clinical outcome, it is difficult to infer from results of cross-sectional studies which show better outcomes in higher-volume units that similar differences in outcomes can be expected by the expansion of an existing unit' (Summary Report, page 10).
• Thresholds: 'The most that the research evidence can support is a conclusion that if there are significant quality gains from increased volume, these gains appear to be exhausted at relatively low threshold levels. Volumes of activity above these thresholds should be achievable without significant structural changes, but may require a more sharply defined internal division of labour across consultant staff (which may be consistent with increased sub-specialisation within disciplines).' (Summary Report, page 11).

Methods

10 A general literature search was undertaken on volume/outcome relationships, together with more focused literature searches on methodological aspects of volume/outcome relationships, on studies relating to volume/outcome relationships which evaluated the impact of an intervention to increase regionalisation, and methodological aspects of assessing clinical 'learning curves'. These searches concentrated on publications from 1997 onwards, although some key references predate this.

11 These literature searches showed that more relevant papers have been published between 1997 and 2004 than were published up to and including 1996 and so it would be a major undertaking to perform a formal systematic review of the more recent literature.

12 This review was therefore selective, based on reading abstracts and obtaining full papers when appropriate and when they were relatively easily accessed. As most papers in this area are observational and cross-sectional by design and are often very specific to a local area (such as a single US state), they tend to be published in low-impact journals which are not held by the local university libraries. Thus most of the full papers reviewed are either from high-impact journals we could access or from journals. whose contents can be accessed electronically.

Results

13 Over 500 abstracts and 50 full papers (see Appendix I of the Report of the Volume/Outcome Subgroup) were reviewed in detail. The vast majority of the papers related to surgical procedures with outcomes assessed in terms of short-term ('in-hospital' or '30-day') mortality. There is also an increasing number of papers relating to surgical oncology with outcomes assessed in terms of long-term (5 years plus) survival.

14 Many common procedures have very low surgical mortality rates, so that even if a volume/outcome relationship does exist for mortality, it would be difficult to demonstrate and might be of limited clinical relevance. So studies focused on morbidity outcomes are also becoming more common. For example, avoidance of a stoma in bowel surgery has a major impact on quality of life, making it a very relevant patient-centred outcome measure (Hodgson et al, 2003), and similar issues apply in prostate cancer (Begg at al, 2002). Sometimes, there may be a long delay between intervention and its consequence (in obstetrics, for instance) and/or the effect may exerted indirectly (such as in screening for cancer), so that 'intermediary' indices of patient outcome are needed.

Methodological quality

15 The York Review (Sowden et al, 1997) was rightly critical of the methodological quality of volume/outcome studies published prior to 1997. There is clear evidence that case-mix adjustment using clinical data on individual patients leads to the most reliable results and that case-mix adjustment using only administrative data tends to overestimate the magnitude of volume/outcome relationships.

16 Studies that use no case-mix adjustment at all are even more likely to overestimate such effects. This is now widely recognised, and methodological standards are higher in recent studies. For example, in the Gandjour review (2003), 16 of the 'best' 33 hospital volume/outcome studies published between 1990 and 2000 were published in 1999 or 2000.

17 Increasingly (and appropriately!) sophisticated statistical approaches are now being used to try to disentangle the complex issue of whether it is surgeon volume or hospital volume which drives the observed volume/outcome relationships (Birkmeyer et al 2003; Panageas et al 2003).

Findings

18 Methodologically flawed studies are still published, but there is now a strong core of methodologically sound papers which use high quality data and appropriate statistical methods to explore volume/outcome relationships. These papers are based either on series of patients with data extracted from administrative systems (giving very large sample sizes but incomplete case-mix adjustment) or on series of patients with data extracted from clinical databases (giving smaller sample sizes but good case-mix adjustment). Even when one restricts attention to these higher quality studies there is still very strong evidence of an association between volume and outcome in the direction that high volume surgeons and high volume hospitals tend to have superior outcomes compared to low volume surgeons and hospitals. The magnitude of this effect, and how it depends on the clinical area, is discussed later in the chapter..

19 Two particularly useful systematic reviews were identified. Halm et al (2002) reviewed studies published between January 1980 and December 2000, and Gandjour et al (2003) reviewed studies published between January 1990 and December 2000.

20 Halm et al was a conventional systematic review covering 27 procedures and diagnoses. In the 135 studies that met their criteria, a statistically significant relationship between higher volume and better outcomes was found for 69% of studies of clinician volume (see Table 9.1) and for 71% of studies of hospital volume (see Table 9.2).

21 The review of Gandjour et al, covered 34 diagnoses and interventions and included another 26 reports not analysed by Halm et al. In a total of 76 studies, higher hospital volume was statistically significantly better in 51, non-significantly better in 21, non-significantly worse in three and significantly worse in only one. These authors took the unusual additional approach of identifying the single most reliable study (based on criteria such as the quality of case-mix adjustment). In 20 such 'best' studies, high volume was significantly better in 10, non-significantly better in six, non-significantly worse in three, and significantly worse in one.

Thresholds

22 Ramsay et al (2001) undertook a systematic review of methods used to analyse learning curves in health care and, more recently, Cook et al (2004) proposed methods for adjusting for learning-curve effects in randomised trials of surgical interventions.

23 There was no clear consensus on appropriate ways to analyse learning effects, with one of the major problems being that as experience is gained in a new technique, it tends to be deployed for higher-risk patients. This means that outcomes can deteriorate as experience is gained. Careful case-mix adjustment is required to interpret this correctly, but almost by definition there is insufficient data for such analyses early in the learning experience.

24 Great importance is placed on volume thresholds by the Leapfrog Group, a large US-based consortium of healthcare purchasers (Birkmeyer et al 2004). The impression from the literature, however, is that definitions of 'low volume' and 'high volume' relate more to potential volumes than to any objective evidence on the actual level of activity required to achieve and/or maintain competence. For example, a unit performing 100 carotid endarterectomies per year could be classified 'high volume', while a unit performing 400 coronary artery bypass graft procedures per year could be classified as 'low volume' (Gandjour et al 2003, Birkmeyer et al 2004).

25 Studies which present outcome data for a range of activity volumes, as opposed to a simple low volume/high volume dichotomy, do often report poor outcomes at low-activity levels, then a levelling-off with outcomes in moderate-volume units being comparable to outcomes in high-volume units. This is partly the result of a statistical artefact, with greater variation being observed in the small samples which derive from low-volume units. There is, however, still evidence of discrepant outcomes being observed in very low-activity units when this excess variation is taken into account (see, for example, the review by Shahian and Normand, 2003).

Causation

26 In spite of very strong evidence of an association between increased volume and better outcomes, there are remarkably few studies that try to assess whether the association is causal. Indeed, it was stated in the York review that there was no evidence that increasing the volume of activity in a given unit would lead to an improvement in outcomes. This reflected a lack of evidence, rather than evidence of a lack of effect.

27 The evidence in this area is still extremely limited, but a number of studies are beginning to appear which evaluate the impact of interventions designed to concentrate activity.

28 Trauma systems are an area with a long history of regionalisation. The different approaches adopted by different countries thus constitute a 'natural experiment' on the organisation of trauma care. Nathens et al (2004) review the history of trauma management in the US and in France, and demonstrate how outcomes of trauma victims improved in the US following the introduction of regionalisation. There was a substantial lag period, however, between the introduction of regionalisation and an observed improvement in outcome.

29 The UK Neonatal Staffing Study Group (2002) reviews the evidence for regionalisation of neonatal intensive care units. The situation is complex, but evidence of volume/outcome relationships from older studies is not seen currently. This is ascribed to lower-volume units adopting developments in treatment that were initially used only in high-volume units. Training and staffing levels appear to be more important than volume per se.

30 The study also raises the caveats that high-volume units with a large number of consultant staff had higher levels of nosocomial bacteraemia, and that units running close to capacity have worse outcomes then when there is 'slack' in the system. These findings on the importance of staffing levels are consistent with the analysis of English hospital death rates published by Jarman et al (1999).

31 Nobilio et al (2004) report on the impact of regionalisation of cardiac surgery in an Italian region. They looked at patient outcomes, accessibility for patients and the efficiency of referral systems following the adoption of a 'hub and spoke' model. The study does provide evidence of benefit, and the authors conclude that their findings suggest 'that policies aimed at increasing cooperation rather than competition among health service providers have a positive impact on quality of care.'

32 This finding is consistent with data from the Lothian Surgical Audit which was presented at the Annual Conference of the Association of Surgeons of Great Britain and Ireland (Robson et al., 2005). In the Lothian experience, restructuring of emergency surgical care, focused on sub-specialisation appropriate to upper and lower abdominal conditions, has led to improved quality of care and outcomes.

Examples of the magnitude of volume/outcome associations

33 Halm et al (2002) summarised volume/outcome effects in terms of absolute differences in mortality between high- and low-volume hospitals (see Tables 9.1 and 9.2). Gandjour et al (2003) presented mortality rates for high-volume relative to low-volume hospitals. Absolute differences in mortality rates of the order of 10% are reported when high-volume units are compared to low-volume units in a number of complex high-risk surgical procedures, including paediatric cardiac surgery, surgery to repair ruptured abdominal aortic aneurysms, pancreatic cancer surgery and oesophageal cancer surgery.

34 Relative differences in mortality rates of at least 10% are reported in a range of common
lower-risk procedures, including percutaneous transluminal coronary angioplasty, carotid endarterectomy, knee replacement and surgery for hip fracture.

Table 9.1

Findings in articles relating physician volume and death: abbreviation of summary data from Halm et al, 2002 Table 3

Table 9.2

Findings in articles relating to hospital volume and death:
abbreviation of summary data from Halm et al 2002

Conclusions from review

35 Returning to the three conclusions extracted from the York Review, it is clear that concerns over case-mix adjustment no longer hold. There is now a core of studies of adequate methodological quality to establish striking volume/outcome associations in certain complex high-risk surgical procedures and more modest but clinically-relevant effects in a wide range of common procedures.

36 There is still only limited evidence to suggest that the observed associations are causal, and that interventions to manipulate volume can lead to better outcomes. It is, however, very important to note that the issue here is that evidence is sparse, rather than there being strong evidence of a lack of a causal association. The relevance of the observed volume/outcome relationships to health service planning depends crucially on how one interprets the underlying mechanisms which generate the associations.

37 The recent literature appears, in general to support the final conclusion of the York Review. Benefits arising from manipulation of volume are likely to be most clearly apparent at a relatively low threshold level.

Commentary: Implications of findings

38 The interpretation of the results of volume/outcome studies is complex. At the time of the York Review, methodological deficiencies in the evidence base meant that the studies had little if any relevance to health service planning. Recent improvements in the methodological rigour of at least a proportion of published volume/outcome studies mean that there is now a large body of credible evidence. This shows both substantial effects in a limited range of complex high risk surgical procedures and modest but clinically relevant effects in a wide range of more general procedures. Questions remain about the nature of the effects and their implications for service planning. Clarification of these depends upon somewhat different avenues of thinking.

39 The effects are likely to be most clear in circumstances where the condition is complex, and its treatment associated with high risk, and where data from substantial numbers of patients are available, covering a wide spectrum of levels of volume. This is reflected in the abundance and consistency of evidence about complex, high risk surgical procedures. This is already accepted into service delivery. Indeed, in specialities such as neurosurgery, cardiac surgery and transplantation, the debate is not if they should be regionalised but if greater, even national concentration is appropriate. Furthermore, the relationship between increased volume and improved outcome in these circumstances is likely to be continuous, with improvement even at relatively high levels of experience. One exception may be if the volume becomes excessive, so that penalties of "overwork" lead to deterioration in outcome.

40 For some disorders, even though evidence is less abundant and the extent of the effect not dramatic (and hence less easy to show and more controversial), the consequences may still be important. For example, reduction by a few percent in mortality for myocardial infarction could save many lives in Scotland.

41 Another issue is the fact that the volume/outcome literature looks at average effects. Although high volume is associated with good outcome in general, there are low volume hospitals whose outcomes are superior to typical high volume hospitals and there are high volume surgeons with poor results who work within high volume hospitals. However this does not deflect the criticism that, in the NHS, too many operations are still taking place in hospitals with low volumes and that this may change if patient choice is effective (Taylor 2004).

42 Is it the volume of activity for an individual surgeon or physician which is important or the volume of the relevant unit or hospital? More studies have looked at hospital volume than have looked at surgeon volume. There is evidence that each can be influential, with perhaps hospital volume stronger but there is no consensus. A related point is whether the surgeon/hospital needs to be 'high volume' for the procedure in question, or is high volume in general associated with good outcomes for all procedures? Urbach and Baxter (2004), for example, argue that volume in general is more important than volume for the specific procedure.

43 There is an increasing focus on indicators of outcome other than mortality. The occurrence of infection or other post-operative complications are generally applicable indices. Procedure specific "clinical" indicators can include: whether intestinal surgery is followed by a stoma or, if this avoided, by anastomosis; recurrence after procedures for hernia and varicose vein; and the persistence of reduced mobility and pain after orthopaedic surgery. Indices appropriate to 'medical' care are well established but rarely if ever available from routine sources of information. Quality control of diagnostic work is well established and recent evidence links volume with accuracy of breast screening. (Théberge et al, 2005). In a service increasingly taking account of patient choice, satisfaction with the whole process of care will need to be taken into account, with the potential of benefit from high volume, highly experienced specialised team care to be set against local familiarity and convenience.

44 It becomes a value judgement to explain the observed volume/outcome relationships. The two widely cited explanations are:- 'practice makes perfect' and 'selective referral' ( i.e. patients are selectively referred to clinicians or hospitals that have historically achieved good outcomes). The former would suggest that volume/outcome associations are causal but the latter would imply that the observed associations are artefactual rather than causal. There are also issues around aspects of process and/or structure which are associated with high volume ( e.g. a large well staffed intensive care unit) and which might lead indirectly to better outcomes.

45 A major current problem in applying these findings is the shortage of evidence supporting the hypothesis that the volume/outcome association is a causal association, whereby manipulating volume will have a beneficial impact on outcome. It should be noted that the problem is a lack of evidence rather than clear evidence of a lack of a causal effect. There is some limited evidence accumulating to support the association as being causal, but a great deal more research is needed in this area. The extent to which benefits can be achieved through diffusion of 'best practice' from 'centres of excellence' needs to be defined. Rigorous evidence of the effectiveness of clinical networks established since 1998 would be important.

46 Service planners may complain of the lack of clear cut, quantitative relationships, particularly concerning thresholds. In practice, the responsibility perhaps now lies with planners to specify the extent of effect that will be crucial in their decision making. Evidence may need to be stronger if it is the only or main factor for change in an existing arrangement. Where reconfiguration is needed in response to other factors, a general presumption of a volume/outcome relationship is a reasonable starting point, and the issue may be more what level of effect is relevant in the circumstances under consideration. The more sensitive the indicator of outcome used, and the more common the condition, the longer the list of interventions to which the volume/outcome effect will be relevant.

B. Designing Highly Specialised Care: Neurosurgery.

47 We commissioned work in two areas to give a 'real world' context to our thinking around specialised care.

48 The analysis of the future configuration of children's tertiary services is set out in Chapter 11. Our thinking in relation to the future configuration of adult and paediatric neurosurgery in Scotland is set out below.

49 In selecting these two areas for detailed scrutiny, we were conscious that a particular set of issues would arise in relation both to low volumes of activity and to reliance on scarce skills and expertise.

50 Through these two areas of work we were also keen to identify a planning approach which would be established as a methodology for use in the NHS when considering specialised services in the future. This approach is evident in the section which follows on adult and paediatric neurosurgery and in chapter 11, and is detailed in the Highly Specialised Care Methodology report which can be found at www.show.scot.nhs.uk/sehd/nationalframework

Adult and paediatric neurosurgery

51 Neurosurgery services in Scotland have been subject to three previous reviews (Carter, 2000; Teasdale, 2003; Scottish Colleges Committee on Children's Surgical Services, 2001). The NHS has nevertheless continued to experience significant difficulties in defining the shape of neurosurgery services for the future. It has also had problems addressing the particular pressures of sub-specialisation in a relatively low-volume speciality, and of workforce disposition to provide 24-hour cover. Some of the existing problems have been exacerbated due to lack of progress in implementing previous reviews' recommendations.

52 We were very aware of the previous work in the field and advice received from professional organisations, but acknowledged the need for objective criteria to support service planning. We didn't want to repeat previous work, but recognised the need to define the level of support for the proposals set out in it, particularly the expressed preference for a single site for neurosurgery in Scotland.

53 We explored a number of themes:

• the need to change
• current range and organisation of services
• current activity
• future needs of neurosurgery
• standards
• clinical and data information needs
• the service model
• configuration of neurosurgery
• future planning and commissioning arrangements for neurosurgery.

54 We adopted a number of techniques and tools to try to take an objective perspective, and referred to the previous work and reports. Data on neurosurgical activity in Scotland and information on travel times to the four neurosurgery units were also assessed. The tools included:

• a self assessment audit by the four centres using the 'Standards for Patients Requiring Neurosurgical Care' developed by the Joint Standards Development Group of the Clinical Standards Committee of the Society of British Neurological Surgeons ( SBNS) and the English Regional Specialised Services Commissioning Group
• an option appraisal involving the agreement of key criteria for the service
• population of the SBNS consultant workforce tool
• securing an independent opinion on medical workforce issues as they impact on the number of locations that can support 24-hour neurosurgical services.

Activity

55 Neurosurgery is currently delivered from four centres: Aberdeen Royal Infirmary and the Royal Aberdeen Children's Hospital; Ninewells Hospital, Dundee; the Western General Hospital and Royal Hospital for Sick Children in Edinburgh; and the Southern General Hospital and Royal Hospital for Sick Children, Glasgow.

56 Each of these units is an integral part of a multidisciplinary neurosciences service and is connected to a university medical school. Each unit provides a 'core service' for its local population and some sub-specialisation on a Scotland-wide basis.

57 The majority of inpatient neurosurgical activity takes place at the Southern General Hospital in Glasgow, which accounts for around 43% of the total. Aberdeen Royal Infirmary and Ninewells Hospital together carry out approximately the same amount as The Western General Hospital in Edinburgh. Significantly more day case activity occurs in Edinburgh than elsewhere.

58 The volume of new outpatient activity is fairly evenly spread across the four centres, but Aberdeen sees more new outpatients as a proportion of total outpatients than elsewhere and is the only centre that does significant outreach. Table 9.3 summaries this activity.

Table 9.3
Neurosurgical activity in Scotland 2002/03 - all ages

Source ISD Scotland (Form ISD(S)1)

Notes: Aberdeen includes Aberdeen Royal Infirmary, Royal Aberdeen Children's Hospital, Woodend Hospital, Tor-Na-Dee Hospital, Raigmore Hospital; Dundee includes Victoria Hospital; Edinburgh includes Western General Hospital, Royal Hospital for Sick Children.

59 The majority of activity in adults is carried out on an elective basis, but this is reversed in children with more emergency activity. In all age groups, the level of transfer is not insignificant, reflecting the degree of sub-specialisation and the role of certain sites as tertiary centres.

60 Despite looking at the needs of patients over a 20-year horizon, including the implications for the next generation of the workforce, we have found it difficult to predict the level and nature of demand. There is no needs assessment in this area. A view was taken, however, on what the need for neurosurgery might be in the future, based on assessing the changes over the last 20 years and our knowledge of technological development and research into, and the development of, drug and therapeutic interventions.

61 We believe the overall level of need may not change, but the type of neurosurgery will. Developments in genomics, drugs and therapeutic interventions will probably have the most significant effect on neurosurgery and the biggest impact on need.

62 It is likely that the complexity of neurosurgery will continue to advance in terms of technological adjuncts, and in the need for these to be delivered in highly-specialised neuroscience centres, such as development of stem cell therapy for Parkinson's disease.

63 A proportion of neurological disease is associated with ageing. The changing demographics of Scotland will therefore influence the nature of demand. We expect an increase in functional neurosurgery - epilepsy and tremors - associated with ageing. We also expect a decrease in paediatric neurosurgery due to the declining birth rate.

64 There is a level of unmet need in some areas, such as epilepsy surgery, that should be addressed. As the population grows older, brain tumours will become more common, meaning an increase in need for neuro-oncology services.

65 Extrapolating from practice in recent years, we believe it is likely that we will see a continued decrease in trauma, with the number of patients with head injuries being admitted to neurosurgical units reducing.

Patient views

66 It is generally accepted that patient expectations have increased and will continue to do so. Neurological Alliance Scotland worked with us to identify the elements of service that are important to patients and develop criteria for the future service.

67 Standards of care set out in the Neurological Alliance document 'Levelling Up' (Neurological Alliance, 2002) were also considered. They are summarised in Table 9.4.

Table 9.4
Neurological Alliance standards of care (Neurological Alliance, 2002)

68 Alliance members advised us to focus on patients and services, not organisations, structures and sites. The key patient priority was the development of an integrated Scotland-wide service. The model should provide equity of access with diagnosis, assessment and treatment provided as locally as possible.

69 They told us that irrespective of the final configuration proposed, the model should adopt a Managed Clinical Network approach on an all-Scotland basis, including clinicians as part of a 'virtual' organisation that actively involved patients in service design. It would also promote interdisciplinary working at all levels and with other agencies, such as voluntary organisations.

70 They acknowledged that a balance needed to be struck between centralisation, critical mass issues and the needs of local and rural communities, and expectations of patients, families
and carers.

Volume and outcome

71 We were particularly keen to understand the extent of the evidence base on the relationship between volume and health outcomes. Specific papers published on neurosurgical interventions were taken into account, and from these, we concluded that there is evidence of a relationship between the volume of procedures undertaken and health outcomes. It is not, however, universal, and the threshold level might be relatively low.

Standards

72 The adoption of, and audit against, explicit standards is a fundamental element in ensuring the service is more integrated with easy access and consistent service quality. The service should work with patients to set out explicitly the standards of care it seeks to deliver, and be prepared to be assessed regularly against these standards.

73 There is still a lack of information about services in Scotland. Items such as activity data, clinical audit and clinical information, which should form an evidence base to support service development, are lacking. Information that is available is either incomplete or the data bases were neither sufficiently large nor consistent to provide meaningful comparison.

74 In designing the service for the future, we are keen that arrangements for participation in data and information collection and clinical audit are included as core components. The NHS should adopt the Department of Health Definitions for Specialised Neurosciences Services, as applicable to Scotland, to support the database.

Workforce issues

75 Some of the key drivers for change in the service are about workforce issues. Workforce pressures are not unique to Scotland and are being felt on a global basis, but NHS Scotland needs to create its own solutions. For neurosurgical services, this means creating satisfying jobs and opportunities for career progression across the spectrum of the workforce.

76 The key issues are:

• the scarcity of skilled staff - medical, nursing and allied health professions ( AHPs)
• the implementation of the new contract for consultant medical staff
• the implementation of the requirements of the Working Time Regulations ( WTR), with particular implications for consultants and junior medical staff
• the demographic changes in Scotland which project a smaller workforce in the future.

77 There are also issues concerning continuing professional development of staff in units with relatively small caseloads and which see limited numbers of cases of unusual type. These include practical issues of cover to release staff to develop skills and experience in sub-speciality areas.

78 Designing and providing a service that recruits and retains these scarce, skilled staff must remain fundamental to neurosurgery in Scotland. In a global market, the service must remain attractive and provide opportunities for career development. It also needs to recognise the contribution and needs of its current staff and acknowledge the potential risk of service reconfiguration on staff retention.

79 Workforce issues concerning implementation of the new Consultant Contract and the WTR could be addressed through employing additional medical staff, if the investment and suitably qualified and experience staff were available. But this would increase consultant numbers to a level where the need expressed in volume of activity from the population catchment of each unit, or indeed for Scotland, would not be sufficient to support maintenance of skills, nor support skills training or acquisition of experience in junior doctors.

Option appraisal

80 An option appraisal was carried out to inform this section of the report. It was beneficial in making explicit the key criteria for the future service model and in informing recommendations on the configuration of the service model.

81 Briefly, the methodology followed was:

1 A number of criteria were identified and agreed

2 A weighting was applied to each criterion using the median score from individual weightings applied by Team members

3 A number of options were identified and agreed

4 The options were scored against the criteria by Team members individually

5 The weightings were then applied to the scored options using the median score from the individual scoring applied by Team members.

82 We agreed 17 options for the configuration of the service (Table 9.5).

Table 9.5
Options for configuration of the service

One Location

1.1 A new location

1.2 Glasgow

1.3 Edinburgh

1.4 Aberdeen

1.5 Dundee

Two Locations

2.1 Glasgow and Edinburgh

2.2 Glasgow and Aberdeen

2.3 Glasgow and Dundee

2.4 Edinburgh and Aberdeen

2.5 Edinburgh and Dundee

2.6 Aberdeen and Dundee

Three Locations

3.1 Glasgow, Edinburgh and Aberdeen

3.2 Glasgow, Edinburgh and Dundee

3.3 Edinburgh, Aberdeen and Dundee

3.4 Glasgow, Aberdeen and Dundee

Four Locations

4.1 Glasgow, Aberdeen, Dundee and Edinburgh - planned proactive change

4.2 Glasgow, Aberdeen, Dundee and Edinburgh - status quo

Outcome

83 We acknowledge that the option appraisal was an inexact process, but it gave us a direction of travel. It allowed us to give serious consideration to the implications of the outcome of the process, and how the model of service, described below, would be organised through the proposed configuration.

84 Table 9.6 summarises the outcome of the option appraisal process. The full detail is in the Neurosciences Action Team report, which can be found at www.show.scot.nhs.uk/sehd/nationalframework

Table 9.6
Total of ranked weighted median scores for options

86 The outcome indicated that Scotland should move from its current configuration (which was rated last in the option appraisal) towards a single centre for neurosurgical intervention for adults and children as part of a service model that would provide local outpatient, rehabilitation, and pre- and post-operative care and diagnosis.

The Neurosurgery Service for Scotland

87 There is consensus that neurosurgery in Scotland should be regarded as a single service delivered on a number of sites. This means that planning, service development and decisions on investment in staff, equipment and facilities will be on an all-Scotland basis.

88 The single service will require planning and commissioning on an all-Scotland level to establish a world class service. It would adopt a managed clinical network approach that would provide an improved service, attract and retain staff, provide a robust basis for research and development, and support academic neurosurgery.

89 Our work identified a number of underpinning components for the service and key criteria for planning.

Service description

90 Adult and paediatric neurosurgery should be co-located on university teaching hospital sites with other neuroscience specialties. It should have access to identified specialty beds, theatre facilities, intensive and high-dependency care and multidisciplinary teams. These teams should provide 24-hour care.

91 The service will be integrated, using a managed clinical network approach, across specialist, secondary and primary care, and will be provided as locally as possible. The service will have explicit standards for care across the integrated care pathway.

92 The integrated service will provide patients with access to a network of care with specialists at the centre. It will be based on agreed patient pathways, supported by protocols providing consistent, equitable care wherever and whenever a patient requires it.

93 The establishment of Managed Clinical Networks for agreed areas will be fundamental to securing integration. The experience of developing Managed Clinical Networks has shown benefits in the development of standards, pathways and, importantly, the involvement of patients. MCNs may have a national, regional or local focus, but clear links between all levels will be important.

94 We agreed that national sub-specialisation, as has already taken place in some areas, should be continued on an ongoing basis and this should be an immediate next step. But experience has shown that this should be done on a planned and managed basis. Initial areas should include acoustic neuroma, epilepsy surgery, functional surgery, cerebrovascular surgery, oncology, pituitary tumours, posterior circulation aneurysms, arteriovenous malformations and complex spinal surgery.

95 This principle should include the sub-specialty of paediatric neurosurgery, which should be concentrated on one prime site co-located with paediatric intensive care. Previous work in this area had indicated that Scotland should move towards a single lead paediatric neurosurgical unit at the centre of a Managed Clinical Network. Care in this unit should be undertaken by sub-specialty paediatric neurosurgeons within a tertiary paediatric service with provision of rapid access to local neurosciences care through a national Managed Clinical Network.

96 The Specialised Paediatric Services Action Team was considering paediatric intensive care provision in Scotland and to ensure consistency with their recommendations, an immediate action should be the establishment of this national Managed Clinical Network.

97 We considered the issue of how unplanned neurosurgical activity would be managed locally within the model. The service model supports local unplanned care and subsequent transfer, where necessary, to specialist services through agreed pathways. It is recognised that there will need to be investment in training of local staff to deliver this and the neurosurgical centres will have a significant role to play in this.

98 The single service can be described as being delivered at a number of levels (Table 9.7). Each level will provide Level N1 for their local population, there will be a number of Level N1 locations within the population covered by a Level N2 location and there will be a number of Level N1 and N2 locations within the population covered by a Level N3 centre.

Table 9.7

Levels of the single service

99 The underpinning components to support the above network of care are:

• development of e-health to support local delivery of diagnosis and care, particularly local access to scanning linked to specialist centres for interpretation and advice
• development of robust information technology infrastructure to support transfer of clinical information across NHS Scotland to support local delivery of care
• transport services for patients to flow into and out of neurosurgical centres in a timely and safe manner.
• a minimum core dataset and agreed, funded audit programme.

100 The integrated service is illustrated in Figure 9.8.

Figure 9.8
Integrated neurosurgical service

Service Specification

• Standards
• Minimum data set
• Audit programme
• Discharge and referral protocols
• Specialist Centre support at all levels (training)
• Transport
• Information
• MCNs

Planning and commissioning model

101 Limited progress with implementing recommendations from previous reviews of neurosurgery indicates that clear accountability is required. This needs to reflect the organisation of the service, which vests accountability with NHS Boards. The strengthened role of Regional Planning Groups may provide opportunities to clarify accountability, but an all-Scotland approach to planning and commissioning neurosurgery is necessary.

102 The difficulties faced by neurosurgery are around workforce issues. It is therefore essential that the planning of neurosurgical services is aligned with workforce planning, including identification and development of education and training programmes.

103 Decisions on major investment in resources of staff, equipment and facilities would be taken on a national basis, using the service model described previously. A national overview will ensure implementation of recommendations and continued service development on a consistent basis.

104 The national approach will enable a consistent service specification to be developed and implemented for NHS Scotland, and will allow trends in neurosurgery to be monitored and consequent changes in service planned.

105 It will also support the centres in working collaboratively in the areas of research and training, providing a larger population catchment. Discussions with the medical schools concerning the organisation of undergraduate and postgraduate training will be required.

106 In planning neurosurgical services for children and young people, the recommendations of the National Framework Child Healthcare Services report (Chapter 11) proposals concerning age-appropriate services should be taken into account.

107 Patient involvement in Managed Clinical Networks has provided many benefits and they should continue to be involved in the planning and development of neurosurgery.

108 There are a number of options in how neurosurgical service planning might be organised:

• Designation as a national service commissioned by National Services Division ( NSD). The service does not meet the criteria for such designation, and this approach has the potential to isolate neurosurgery from other specialities locally.
• An individual NHS Board would take lead responsibility on behalf of NHS Scotland. This would require infrastructure and resource to support. Experience with other services has shown limited success for this approach.
• Regional Planning Groups take responsibility, either by working collaboratively or by one of the groups taking lead responsibility.
• The Scottish Executive Health Department assumes leadership responsibility for planning neurosurgery, establishing a National Planning function to co-ordinate those services where an all-Scotland approach is considered appropriate. This National Planning function would link with Regional Planning Groups to ensure co-ordination between national and regional agendas - this is the preferred option.

Organisation and location of services

109 Specialist centres must provide practical support to local teams in terms of skills and gaining experience. This can be done through multi-disciplinary outreach and in-reach being focused on education opportunities, development of video and telephone conferencing for advice and training, and the establishment of more outreach services, including potentially one-stop diagnostic clinics. These could be developed through agreed service frameworks between specialist centres and local services which complement Managed Clinical Networks. They would be part of the specification for the service commissioned on a national basis.

110 The pattern of work will need to be re-organised to ensure that staff time is utilised effectively. Rotations and the organisation of outreach services on a block basis, such as spending complete days in local hospitals, will need to be explored.

111 The configuration of the service model depends on how many locations NHS Scotland can support to give 24/7 care in neurosurgery. This refers to Level N3 in the service model described previously.

112 Interventions that do not require 24 hour/7 day care were identified. These might be limited to common spinal surgery which, although of relatively high volume in neurosurgery, would not constitute a substantial service nor be an attractive job for staff.

113 In considering the entirety of the issues associated with providing a neurosurgery service, particularly the service model which establishes it as a single national service, underpinned through standards and audit, we consider that the current configuration of neurosurgery is not the optimal way to continue to provide comprehensive, high quality care to patients.

114 There is consensus that the service should move towards one prime site for adult and paediatric neurosurgery within a network of care as previously described.

Summary of Recommendations

• NHS Scotland should move towards providing adult and paediatric neurosurgical intervention on one prime site for the whole of Scotland within the service model described in this report.
• Neurosurgery should be regarded as a single service for Scotland, delivered on a number of sites.
• Neurosurgery services should be planned and commissioned on a national basis, with future decisions concerning investment in staff, facilities and equipment taken through the planning and commissioning model described in this report. Decisions should not be taken by individual NHS Boards. Staff may be appointed to geographic areas wider than individual NHS Boards.
• SEHD should assume strategic leadership responsibility for planning and commissioning neurosurgery on an all-Scotland basis, working with Regional Planning Groups and NHS Boards.
• A needs assessment for neurosciences should be undertaken to support future planning of services. This should initially be undertaken by the implementation team identified to take forward the recommendations of this report, and thereafter should form part of the planning arrangements.
• Patients should continue to be involved in the future planning of neurosurgical services, both locally and in the service model adopted for NHS Scotland. Patients and patient representative groups should be at the centre of future development and decision making.
• Explicit standards for the neurosurgery service should be agreed and set out in the service model. This should also include a mechanism for assessment against these standards and action plans to address areas for improvement. Patients should be involved in this process.
• The standards should be based on the SBNS standards currently being used elsewhere in the UK and the service should work with the SBNS in their further development. The service should make them relevant to Scotland while ensuring comparison with other units.
• Neurosurgery centres should work collaboratively to address areas for improvement, sharing good practice and developing action plans.
• A common minimum data set of activity information should be agreed, collected and reported back to the service to inform planning and performance management. The data set should be relevant to the service and based on Department of Health definitions.
• The future planning of neurosurgery should take account of evidence in the field of associations between volume and health outcomes.
• A planned audit programme for the service should be developed, agreed and maintained. Arrangements including funding for clinical audit and data collection, analysis and reporting should be main-streamed into the future model for neurosurgery.

References

Begg CB, Riedel ER, Bach PB, et al. (2002) Variations in morbidity after radical prostatectomy.
N Eng. J Med 346: 1138-1144.

Birkmeyer JD and Dimick JB. (2004) Potential benefits of the new Leapfrog standards: effect of process and outcome measures. Surgery 135: 569-575.

Birkmeyer JD, Stukel TA, Siewers AE, et al. (2003) Surgeon volume and operative mortality in the United States. N Eng J Med 349: 2117-2127.

Carter D (2000) Review of Neurosurgical Services in Scotland

Cook JA, Ramsay CR and Fayers P. (2004) Statistical evaluation of learning curve effects in surgical trials. Clinical Trials 1: 421-427.

Gandjour A, Bannenberg A and Lauterbach KW (2003) Threshold volumes associated with higher survival in health care. A systematic review. Med Care 41: 1129-1141.

Halm EA, Lee C and Chassin MR. Is volume related to outcome in health care? A systematic review and methodological critique of the literature (2002) Ann Intern Med 137: 511-520.

Hodgson DC, Zhang W, Zaslavsky AM et al (2003) Relation of hospital volume to colostomy rates and survival for patients with rectal cancer. J Natl Cancer Inst 2003; 95:708-16

Jarman B, Gault S, Alves B, et al. (1999) Explaining differences in English hospital death rates using routinely collected data. BMJ 318: 1515-1520.

Luft HS, Bunker, JP, Einthoven AC. (1979) Should operations be regionalised? The relationship between surgical volume and mortality. NEJ Med 301 1364-1369.

Nathens AB, Brunet FP and Maier RV. (2004) Development of trauma systems and effect on outcomes after injury. Lancet 363: 1794-1801.

Neurological Alliance (2002) Levelling Up: Standards of Care for People Living with a Neurological Condition.

Nobilia L, Fortuna D, Vizioli M, et al. (2004) Impact of regionalisation of cardiac surgery in Emilia-Romagna, Italy. J Epidemiol Community Health 58: 97-102.

Panageas KS, Schrag D, Riedel E et al. (2003) The effect of clustering of outcomes on the association of procedure volume and surgical outcomes. Ann Intern Med 139: 658-665.

Ramsay CR, Grant AM, Wallace SA, et al. (2001) Statistical assessment of the learning curves of health technologies. Health Technology Assessment 5 (12): 1-98.

Robson AJ, Richards JMJ, Nixon SJ and Paterson Brown S (2005) Specialisation of Emergency Surgery in the Management of Perforated Peptic Ulcer Disease. Br J Surgery Vol 92 Suppl 1 p147 April 2005

Scottish Colleges Committee on Children's Surgical Services (2001) Report on the Short Life Working Party on Paediatric Neurosurgery, October 2001.

Shahian DM and ST Normand. (2003) The volume-outcome relationship: from Luft to Leapfrog. Ann Thorac Surg 75: 1048-1058.

Sowden AJ, Grilli R and Rice N. (1997) The relationship between hospital volume and quality of health outcomes.CRD report 8, part 1. York: Centre for Reviews and Dissemination

Teasdale G (2003) Planning for the Future Provision of Neurosurgical services in Scotland: The Neurosurgical Viewpoint

Théberge I, Hébert-Goteau N, Langlois Et al. Volume of screening mammography and performance in the Quebec population. Breast Cancer Screening Programme. CMAJ, 2005, 172: 195-9.

The UK Neonatal Staffing Study Group (2002) Patient volume, staffing, and workload in relation to risk-adjusted outcomes in a random stratified sample of UK neonatal intensive care units: a prospective evaluation. Lancet 359: 99-107.

Urbach DR and Baxter NN. (2004) Does it matter what a hospital is "high volume" for? Specificity of hospital volume-outcome associations for surgical procedures: analysis of administrative data. BMJ 328: 73

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