A comparison of clinical practice guidelines for proximal femoral fracture

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Anaesthesia 2013, 68, 159–166

doi:10.1111/anae.12076

Original Article A comparison of clinical practice guidelines for proximal femoral fracture R. J. Kearns,1 L. Moss2 and J. Kinsella3 1 Consultant Anaesthetist, 2 Clinical Physicist and Honorary Lecturer, 3 Head of Section, Academic Unit of Anaesthesia, Pain & Critical Care Medicine, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK

Summary Clinical practice guidelines are designed to assist clinical decision-making by summarising evidence and forming recommendations. The number of available guidelines is vast and they vary in relevance and quality. We reviewed guidelines relevant to the management of a patient with a fractured neck of femur and explored similarities and conflicts between recommendations. As guidelines are often produced in response to an area of clinical uncertainty, recommendations differ. This can result in a situation where the management of a particular clinical problem will depend upon which guideline is followed. We explore the reasons for such differences. .................................................................................................................................................................

Correspondence to: R. Kearns Email: [email protected] Accepted: 2 October 2012

In 1990, the Institute of Medicine proposed that clinical practice guidelines be developed in order to bridge the gap between evidence and practice, reduce variations in healthcare, assist clinical decision-making, improve patient care and decrease costs [1]. While opinion and consensus amongst practitioners with years of clinical wisdom provide guidance to those with less experience, the paradigm shift of recent years has led away from eminence and towards evidence as the basis for best practice. Increasingly, guidelines may be referred to as examples of customary or best practice [2]. In common with all health professionals, anaesthetists are faced with complex patients in whom several clinical guidelines may apply. The peri-operative management of proximal femoral fracture is an important example of a challenging clinical area where evidence Anaesthesia © 2012 The Association of Anaesthetists of Great Britain and Ireland

is lacking and practice varies [3]. Proximal femoral fracture is a common, serious and costly condition that occurs in an increasingly elderly, frail and dependent patient population [4, 5]. It is estimated that 70 000– 80 000 cases of proximal femoral fracture occur annually in the UK [6, 7]. This is projected to rise to around 100 000 cases in England alone by 2033, with an estimated associated cost of £3.6–5.6 billion [8]. The vulnerability of this patient group is apparent in the associated prolonged length of hospital stay, complex care journey, ongoing care needs, and high levels of morbidity and mortality [9]. Data from national audit suggest a consistent and persistent mortality rate of around 7–10% at one month and 30% at one year [3, 7, 10]. Proximal femoral fracture therefore results in significant levels of financial and human expenditure, and is a burgeoning public health challenge [8, 11, 12]. 159

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Several guidelines designed to standardise and improve care in this vulnerable patient group have been created over the last five years [13–17]. We reviewed guidelines relating to the management of proximal femoral fracture, exploring the similarities, differences and conflicts encountered.

Methods The PubMed, Medline, Embase and Cochrane databases were searched for papers in the English language published from 1996 to September 2012 using the search terms ‘clinical practice guidelines’, ‘practice policies’, ‘protocols’ and ‘consensus statements’, and combining these with ‘femoral fracture’ and ‘hip fracture’. Current local and national (UK) guidelines relating to the peri-operative management of proximal femoral fracture were accessed via the former NHS National Library of Guidelines [18] and NHS Evidence websites [19]. The websites of relevant government organisations, professional societies, and guideline publishers were reviewed for publications of interest, and reference lists examined.

Results Five UK clinical guidelines, issued over a five-year period, were identified, issued by: the British Orthopaedic Association/British Society of Geriatricians (BOA/BSG 2007) [13]; the Scottish Intercollegiate Guideline Network (SIGN 2009) [14]; the National Institute for Health and Clinical Excellence (NICE 2011) [15]; the Association of Anaesthetists of Great Britain and Ireland (AAGBI 2011) [16]; and the British Orthopaedic Association (Standards for Trauma; BOAST 2012) [17]. Guidelines ranged in length from one to 664 pages.

General recommendations and timeline All guidelines highlighted the inherent high levels of comorbidity and frailty within this patient group, advising a thorough assessment of the cause of the fall and premorbid level of physical and cognitive function. Recommendations relating to general aspects of management such as delivery of adequate patient information, multidisciplinary management, the benefits of orthogeriatric input, a dedicated trauma team and theatre list, and consultant-delivered care were com160

mon to all guidelines. General care issues including pressure area protection, nutritional assessment and supplementation, adequate hydration, and coordinated rehabilitation with supported discharge were also consistently acknowledged. The timeliness of surgery was addressed in all guidelines. A four-hour time period from hospital to orthopaedic ward admission was specified in BOA/ BSG 2007, NICE 2011 and AAGBI 2011 publications. This was reduced to two hours in SIGN 2009, and was not specified in the updated BOAST 2012 guideline. All guidelines emphasised the advantages of expedited surgery with all but SIGN 2009 setting a standard of surgical repair on the day of or day after surgery, and within daylight hours. This was reduced to 24 hours in the SIGN 2009 guideline.

Analgesia Both SIGN 2009 and AAGBI 2011 advised early analgesia in the pre-hospital setting while the remaining guidelines focused on management in the emergency department. Guidelines generally recommended the use of regular oral paracetamol, the avoidance of nonsteroidal anti-inflammatory drugs, and the regular assessment of pain at rest and movement (taking into account the potential for decreased capacity to express pain). The BOA/BSG 2007 guideline specified that oral or intramuscular opioids should be used in preference to the intravenous route, with codeine and tramadol also considered as useful agents. This is in contrast to the SIGN 2009 and AAGBI 2011 guidelines, which advised the careful titration of intravenous morphine, and the avoidance of oral opioids and codeine due to adverse effects such as constipation and peri-operative cognitive dysfunction. There was a lack of cited evidence in this area. The use of peri-operative nerve blockade was discussed in SIGN 2009, NICE 2011 and AAGBI 2011. All three guidelines, after considering the same 2002 Cochrane review [20], concluded that peripheral nerve blockade should be considered as an adjunct for both pre- and postoperative analgesia. The NICE 2011 guideline specified further that peripheral nerve blockade should only be added if analgesia was inadequate after administration of paracetamol and titration of opioid. Anaesthesia © 2012 The Association of Anaesthetists of Great Britain and Ireland

Kearns et al. | Clinical practice guidelines for proximal femoral fracture

Anaesthesia The conduct of anaesthesia was discussed in all guidelines with the exception of BOAST 2012. Conclusions made by both SIGN 2009 and NICE 2011 were based on the results of a 2004 Cochrane meta-analysis of 22 studies [21], with an additional paper on cost-effectiveness included by NICE [22]. While SIGN 2009 made a consensus recommendation that regional anaesthesia should be considered for all patients unless contraindicated, NICE 2011 acknowledged only that patients should be offered the choice between regional and general anaesthesia after individualised consideration of the risks and benefits. The AAGBI 2011 publication considered a further, more recent meta-analysis that included 18 715 patients from 34 randomised controlled trials, 14 observational studies and eight reviews [23]. The conclusions of this work were reflected in the recommendation that regional anaesthesia should be the preferred technique. However, the importance of patient-centred, multidisciplinary decision-making and considerate anaesthesia (regardless of technique) was highlighted. Further recommendations by AAGBI 2011 included: consideration of peripheral nerve blockade in all cases; lower doses of local anaesthetic and the lateral position to reduce haemodynamic compromise with neuraxial block; the use of fentanyl in preference to morphine or diamorphine for spinal anesthesia; and avoiding the combination of general anaesthesia and neuraxial block. Pragmatic guidance relating to the administration of general anaesthesia was also given.

Anticoagulation and antiplatelet therapy Guidelines differed in their approaches to this issue. Recommendations are summarised in Table 1. It should be noted that guidelines on the peri-operative management of anticoagulation not specific to patients undergoing proximal femoral fracture repair are also available [24–27].

Cardiac murmur and anaemia The presence of an undiagnosed systolic murmur is a common dilemma in this patient group. This is highlighted in the 2001 NCEPOD report [28], and this document is therefore included in the analysis. Guidance is summarised in Table 2. Anaesthesia © 2012 The Association of Anaesthetists of Great Britain and Ireland

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Recommendations regarding anaemia are summarised in Table 3.

Discussion The care of an elderly patient arriving in hospital at 11:00, who spent three hours in the emergency department, received oral opioids, was found to have an asymptomatic murmur, and was investigated with an echocardiogram before being operated on the following afternoon, would be compatible with the BOA/BSG 2007, NICE 2011 and BOAST 2012 guidelines, whilst various aspects of the same patient’s management would be contrary to AAGBI 2011 (in at least two aspects) and SIGN 2009 (in at least three aspects). It is also relatively easy to select other examples that are completely compatible with the SIGN 2009 and AAGBI 2011 guidelines but are contrary to the other guidelines. So why do guidelines differ? Chronology undoubtedly plays a major role. It is clearly impossible that a guideline published five years ago could appraise the same evidence as one published years later. Conversely, the authors of a new guideline might find that there is no recent evidence to review and be forced to analyse studies that are out of date and do not reflect current practice. While this situation might seem surprising in view of the inexorable increase of the medical literature [29], it is not infrequently encountered (as illustrated in the review of anaesthetic technique for proximal femoral fracture repair). Furthermore, guidelines may vary in the literature reviewed, even when they are published at around the same time. This may relate to different search strategies and criteria, or may reflect differing perspectives and intended readership. For example, although the AAGBI 2011 and NICE 2011 hip fracture guidelines were both published in the same year, they differ in the literature reviewed on anaesthetic technique. While both guidelines consider the 2004 Cochrane review by Parker and colleagues [21], the AAGBI document also includes the larger, more recent meta-analysis by Luger et al. [23]. The reasons for this are not clear, though may reflect the different timescales in which guidelines are created, as well as the marginally later publication date of the AAGBI guideline. The AAGBI guideline is cliniciandriven and patient-focused, placing a greater emphasis 161

162

Not mentioned

Not mentioned

SIGN 2009 [14]

NICE 2011 [15]

Not mentioned

BOAST 2012 [17]

Not mentioned

< 1.5 (follow hospital guidelines)

Not mentioned

Small amounts may be given (with supplemental heparin)

INR should be corrected promptly to avoid undue delay

Oral or intravenous (1.0–2.5 mg suggested)

Absence of relevant research

Vitamin K for reversal of warfarin

INR, international normalised ratio. BCSH, British Committee for Standards in Haematology.

< 2 (follow hospital guidelines)

AAGBI 2011 [16]

Not mentioned

Not mentioned

Not mentioned

< 1.5

BOA/BSG 2007 [13]

Source

Acceptable INR for neuraxial block

Acceptable INR for surgery

Not mentioned

Not mentioned

Not mentioned

Should be used in accordance with BCSH guidelines

Absence of relevant research

Fresh frozen plasma for reversal of warfarin

Not mentioned

Expensive and rarely indicated

Not mentioned

Not mentioned

Not mentioned

Plasma thromboplastin component for reversal of warfarin

Not mentioned

Aspirin may be withheld during inpatient stay, unless indicated for unstable angina or recent / frequent transient ischaemic attacks. Clopidogrel generally not stopped on admission. Surgery should not be delayed. Platelets should not be administered prophylactically. Higher than normal surgical blood loss should be expected

Not mentioned

Surgery should not be delayed. General anaesthesia recommended in patients taking dual antiplatelet therapy. Transfuse platelets only in the event of excessive surgical bleeding

Clopidogrel: multidisciplinary discussion required

Antiplatelet drugs

Table 1 Summary of guidance for the management of anticoagulant/antiplatelet drugs in patients undergoing repair of proximal femoral fracture.

Anaesthesia 2013, 68, 159–166 Kearns et al. | Clinical practice guidelines for proximal femoral fracture

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Kearns et al. | Clinical practice guidelines for proximal femoral fracture

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Table 2 Summary of guidance for the management of cardiac murmurs in patients undergoing repair of proximal femoral fracture. Source

Indications for pre-operative echocardiography

BOA/BSG 2007 [13]

If an echocardiogram can be obtained without causing delay, the information may be useful. The absence of echocardiography should not lead to delays in fixing the fracture

SIGN 2009 [14]

Older people with hip fracture do not require routine additional cardiac investigation such as echocardiography before surgery. Echocardiography should be performed if aortic stenosis is suspected, to allow confirmation of diagnosis, risk stratification and any future cardiac management. The need for echocardiography, based on clinical history, physical examination and ECG findings should not delay surgery unduly. Rapid access to an echocardiography service is recommended for appropriate patients to avoid unnecessary delay to surgery

NICE 2011 [15]

Not addressed

AAGBI 2011 [16]

Echocardiography may be indicated: (i) to establish left ventricular function if the patient is breathless at rest or on low-level exertion (ii) to investigate the severity of an ejection systolic murmur heard in the aortic area, particularly if significant aortic stenosis is suggested by two or more of: – a history of angina on exertion – unexplained syncope or near syncope – a slow rising pulse – an absent second heart sound – left ventricular hypertrophy on the ECG without hypertension (although clinical signs of aortic stenosis can be difficult to elicit). “Awaiting echocardiography” is an unacceptable reason to delay surgery. A majority of clinicians favour proceeding to surgery with modification of their technique towards general anaesthesia and invasive blood pressure monitoring, with the proviso that patients should undergo echocardiography in the early postoperative period. Not addressed

BOAST 2012 [17] NCEPOD 2001 [28]

An asymptomatic cardiac murmur may indicate significant cardiac disease and should be investigated pre-operatively by echocardiography

ECG, electrocardiogram

Table 3 Summary of guidance for the management of anaemia in patients undergoing repair of proximal femoral fracture. Source

Peri-operative management of anaemia

BOA/BSG 2007 [13]

Transfusion may be required as a drop in haemoglobin concentration of 2–3 g.dl 1 over the peri-operative period can be anticipated in most patients. In the absence of reliable evidence to guide the use of blood transfusion after hip fracture surgery, practice varies considerably. Local protocols are variably in use. Further research is required

SIGN 2009 [14]

Comments on paucity of evidence in this area. Suggests referral to SIGN guideline on peri-operative blood transfusion

NICE 2011 [15]

Anaemia should be identified and corrected to avoid unnecessary delay to surgery

AAGBI 2011 [16]

Pre-operative transfusion should be considered for a haemoglobin concentration < 9 g.dl 1, or < 10 g.dl 1 with a history of ischaemic heart disease. If haemoglobin concentration is 10–12 g.dl 1, two units of blood should be crossmatched. If haemoglobin concentration is within normal limits, a grouped sample is sufficient. Consider cell salvage for peri-prosthetic fractures or revision surgery

BOAST 2012 [17]

Identify and treat correctable co-morbidities immediately so that surgery is not delayed

on the practical issues surrounding the patient journey, whilst NICE must balance an over-arching responsibility for the fair and optimal use of resources, with that of current best practice and clinical will, and is Anaesthesia © 2012 The Association of Anaesthetists of Great Britain and Ireland

accountable to Government. This may at times create a challenging counterpoise. Differences in guidelines may result in fundamental differences in practice and are an important phenomenon. 163

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Barriers to guideline compliance are well documented in a recent article by Carthey and colleagues [30]. The exponential increase in the number of published guidelines brings with it an inherent variability in guideline quality, an issue actively addressed by the AGREE (Appraisal of Guidelines for Research and Evaluation) collaboration [31, 32]. The AGREE II tool is designed to “assess the quality of practice guidelines across the spectrum of health, provide direction on guideline development, and guide what specific information ought to be reported in guidelines” [32]. However, such tools are not infallible and have limitations. The AGREE II instrument is one of the most well-validated tools for guideline methodological assessment and incorporates 23 items within six domains: scope and purpose; stakeholder involvement; rigour of development; clarity of presentation; applicability; and editorial independence [32]. Within this process, methodological processes are systematically assessed. However, the quality of the literature and the appropriateness of the conclusions reached are not independently evaluated. This leaves the potential for unanswered questions on a guideline’s clinical validity. Equally, while allowing for a degree of comparison to be made between different guidelines on a topic, there is no watershed mark by which a guideline on a particular topic can universally be considered acceptable or clinically apt. Although AGREE II is undoubtedly a welcome addition to guideline development processes, it may not yet be adequate to determine the utility of an individual guideline fully. Thus, even guidelines produced by organisations granted the AGREE seal of approval are not immune to criticism [33, 34]. This raises further questions regarding the legal implications of guidelines. In correspondence following a much discussed editorial on NICE guidance of CardioQTM monitoring [35], Ghosh and colleagues suggest that clinicians might fear claims of negligence if they do not follow guidance produced by high-profile organisations such as NICE. They also consider that the incorporation of guidelines into the Comission for Quality and Innovation (CQUIN) framework is likely to result in further financially motivated pressures to comply [35, 36]. In reply to recent similar criticisms [37], NICE responded by clearly stating that guidelines are “not in any way mandatory” and are designed to help “healthcare professionals and patients make 164

informed choices” [38]. Despite these reassurances, the quasi-legal status of guidelines is a matter of understandable anxiety and uncertainty. In medical litigation, the main question that must be answered is whether or not a doctor has provided a standard of ‘reasonable care’ as required by law. This is judged by taking into account the circumstances surrounding a particular situation, and balancing the differences inherent in medical practice against the interests of the patient. Traditionally, the standard of care in law has been determined according to the Bolam test [39]. This is based on the principle that a doctor does not breach the legal standard of care, and thus is not negligent, if their practice is upheld by a responsible body of professionals with expertise within the same clinical field. However, this doctrine may be criticised as relying unduly upon medical testimony with insufficient attention to the interests of the patient. More recently, there has been a move towards the requirement for an explanation of the logic underlying the standard of care that is deemed acceptable by the ‘body of medical opinion’. This is known as the Bolitho test and as a result the Courts enquire in increasing detail into the analysis of events, supporting evidence base, and risk analysis of other courses of action [40]. Therefore, although accepted practice will be established in the Court by the invitation of expert testimony, guidelines may be increasingly referred to by expert witnesses, and by the judge, as evidence of customary and accepted best practice. Superficially, it could seem reasonable to suggest that a competent clinician should follow all the recommendations in an evidence-based guideline, all the time. However, this assumes that the guideline is completely up to date, uses only completely robust evidence, and is entirely applicable to the patient in question. Unfortunately, or perhaps fortunately, the medical literature is expanding rapidly at a rate far exceeding that possible for guideline production. The process by which guidelines are formed is hugely resource- and labour-intensive and cannot at present be repeated for every new piece of evidence that is produced. For example, a recently published, large, multicentre randomised controlled trial examining liberal versus restrictive blood transfusion in patients undergoing proximal femoral fracture repair concluded that Anaesthesia © 2012 The Association of Anaesthetists of Great Britain and Ireland

Kearns et al. | Clinical practice guidelines for proximal femoral fracture

there was no advantage in adopting a higher transfusion threshold even in elderly patients at high risk of cardiovascular disease [41]. This new evidence is not incorporated in recent guidelines on hip fracture as it would have been unavailable during the period of research undertaken in this area. In addition, the timely implementation of a guideline, even if there is general agreement on its merit, can undoubtedly create significant challenges in terms of resources, cost and training. The presence of conflicting, out-of-date or methodologically flawed guidelines could clearly have far-reaching consequences, and yet is hard to avoid in reality. Equally, the presence of guidelines containing polarised advice could highlight that the area under investigation is one in which there is clinical uncertainty and thus aid both defendant and claimant on the same issue. Until these issues are resolved, if they ever are, guidelines should serve as a source of reference regarding best practice, and not be legally binding. Despite this, it is certainly plausible that high-quality, peer-reviewed guidelines produced by a professional group (such as the AAGBI) may be seen as consistent with the tenets of both Bolam and Bolitho, and thus realise a greater importance as a source of reference during court proceedings. As discussed recently, it would seem reasonable that clinicians should be prepared to justify any major deviations from relevant guidelines [42]. Advances in technology may provide potential solutions to some of the issues described above. The SIGN guidelines are now being published in electronic rather than paper based formats to allow them to be read on mobile devices [43], and NICE has also taken measures to improve user-friendliness by creating ‘pathways’ mapping all sources of guidance on a particular topic [44], and by enhancing its website. It is hoped that these measures will help to increase awareness, accessibility and utility of guidelines, providing useful information where needed at a clinical interaction. Similarly, the Artificial Intelligence in Medicine research field recognises the inherent challenges (and potential advantages) of managing multiple, complex, clinical guidelines and is currently active in the development of methodologies and systems to aid in this task [45, 46]. Although many advances have been made in the technology supporting the computerisation of guidelines, further investigation into which populations Anaesthesia © 2012 The Association of Anaesthetists of Great Britain and Ireland

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to target, types of system to use, and most importantly, effects on patient outcomes and cost-effectiveness, are needed. The recognition that poorly programmed systems may result in actual harm due to poor training, human error, or improper use of software is also important, and highlights the need for caution when such technologies are introduced into clinical practice [47]. Development and validation of the necessary technology represents only one of the barriers to its successful integration into the clinical environment. If the promise of its considerable potential is ever to be realised, advances must be made not only within the technical domain, but in the social, educational and cultural change that must accompany it.

Competing interests JK is Deputy Chairman of SIGN. No external funding or other competing interests declared.

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