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Patient decision aids in knee replacement surgery
The Knee 19 (2012) 746–750
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The Knee
Review
Patient decision aids in knee replacement surgery Chethan Jayadev a, Tanvir Khan a, Angela Coulter b, c, David J. Beard a, Andrew J. Price a,⁎ a b c
NIHR Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Science, University of Oxford, United Kingdom Foundation for Informed Medical Decision Making, Boston, Massachusetts, USA Department of Public Health, University of Oxford, United Kingdom
a r t i c l e
i n f o
Article history: Received 12 September 2011 Received in revised form 5 February 2012 Accepted 7 February 2012 Keywords: Decision aids Shared decision-making Arthroplasty Knee replacement surgery
a b s t r a c t Arthroplasty is an effective intervention for symptomatic knee osteoarthritis refractory to conservative therapy. However, recent data highlights regional variations in service provision unrelated to disease severity and a low, but not insignificant, rate of patient dissatisfaction. The variation in knee arthroplasty provision is in part also due to the clinical decision-making of orthopaedic surgeons. The management of osteoarthritis is an example of a preference-sensitive clinical pathway, and possible explanations for poor patient satisfaction include unrealistic expectations and poor perception of potential benefits and risks. In addition to the individual impact, this represents an inefficient use of resources by healthcare providers during a challenging economic period. Improved shared-decision making between patients and clinicians would potentially address these issues. Patient decision aids provide relevant personalised evidence-based information to facilitate the shared decision-making process. Orthopaedic surgeons are receptive to the use of patient decision aids to support shared decision-making, but there are a number of issues to overcome before they are routinely adopted. The number of decision aids and the literature supporting their effectiveness is growing rapidly. NHS Direct has launched online patient decision support for knee osteoarthritis. The use of patient decision aids in clinical practice is gathering pace and may soon become the ethical and legal standard. This article provides a narrative review of patient decision aids in the context of knee replacement surgery from a UK perspective. © 2012 Elsevier B.V. All rights reserved.
Contents 1. 2. 3. 4.
Introduction . . . . . . . . . . . . . . . . . . Shared decision-making . . . . . . . . . . . . Patient decision aids . . . . . . . . . . . . . . Rationale for decision aids in knee arthroplasty . 4.1. Unwarranted variation in service provision 4.2. Patient satisfaction and selection . . . . . 4.3. Financial constraints . . . . . . . . . . . 5. Effectiveness of decision aids . . . . . . . . . . 6. Accuracy and quality of decision aids . . . . . . 7. Orthopaedic opinion and practice . . . . . . . . 8. Conclusions . . . . . . . . . . . . . . . . . . Author contributions . . . . . . . . . . . . . . . . Funding sources . . . . . . . . . . . . . . . . . . Conflict of interest statement . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . .
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1. Introduction ⁎ Corresponding author at: Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, Botnar Research Centre, Windmill Road, Oxford OX3 7LD, United Kingdom. Tel.: + 44 1865 737539; fax: + 44 1865 227671. E-mail address: [email protected] (A.J. Price). 0968-0160/$ – see front matter © 2012 Elsevier B.V. All rights reserved. doi:10.1016/j.knee.2012.02.001
Patient decision aids are tools designed to help patients make difficult decisions about their investigations and treatments. They are used in preference-sensitive health care choices; where there is
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more than one way to treat a condition with no clinical evidence to suggest one option is better than another. Decision aids help patients in deciding which of the available options will be best for them. The National Health Service (NHS) is being remodelled to give patients “more choice and control, backed by an information revolution” [1]. The principle is “no decisions about me without me”. NHS Direct already offers online decision aids for knee and hip osteoarthritis. Orthopaedic surgeons are receptive to the use of patient decision aids to support shared decision-making. In a survey of UK consultant orthopaedic surgeons who perform joint replacement surgery, 79% responded that the use of patient decision aids is a “good” or “excellent” idea [2]. The aim of this article is to provide on overview of patient decision aids with the context and rationale for their emerging use in knee arthroplasty. 2. Shared decision-making Patients want greater involvement in decisions regarding their care. Up to 75% of patients believe that treatment decisions should be made by them alone, or together with their doctor [3]. Consequently, it has been argued that the doctor–patient relationship should shift from paternalism to a partnership [4]. This is reflected in ethical guidance for doctors produced by the General Medical Council [5]. Like any good partnership confronted with a difficult choice, a mutual understanding of needs and expectations is required to make a shared decision with shared responsibility. Shared decision-making requires collaboration between the patient and clinician to reach an informed decision on the most appropriate course of action. This is based on the best available clinical evidence and the patient's needs, priorities, perceptions and values [6,7]. The practice of shared decision-making is most apt for preference-sensitive health care choices such as arthroplasty for osteoarthritis (OA). There are several reasonable possible actions and each option has its own risk–benefit profile. The objective is that the agreed management plan is consistent with the patient's values. The model is rapidly becoming the established ethical, political and professional paradigm [8]. The NHS has promised that “shared decision-making will become the norm” [1]. Patients should always make the ultimate decision about their care and this is manifest in their right to autonomy, requirement to consent and adherence (or not) to the care plan. However, if they are not fully informed about the options and encouraged to participate, they cannot be autonomous decision makers. Some prefer the term informed decision-making, in contrast to the more passive notion of informed consent, as this crystallises the essence of the approach [9]. There is a bi-directional exchange of information. The clinician must convey their expertise on diagnosis, prognosis, and treatment options with their effectiveness, benefits and potential risks. The patient must assimilate this information to identify and communicate their personal priorities, attitudes and values to the risk–benefit profile of each option. The subsequent agreement on the management plan is based on this exchange. 3. Patient decision aids Patient decision aids are tools that provide patients with the relevant evidence-based information to facilitate the shared decisionmaking process. They provide estimates of the benefits and risks of the available options in sufficient detail to allow patients to weigh up the pros and cons and make specific personal choices about treatment. They are an adjunct to the doctor–patient encounter and not a substitute. The aims of using decision aids are to [10]: 1. Enhance patients' knowledge of the available treatment or management options, quantifying their risks, benefits and likelihoods.
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2. Help clarify expectations, perceptions, priorities and values. 3. Engage patients in the decision making process and offer structured guidance in deliberation. Decision aids can be self- or clinician administered. They exist in multiple formats: booklets and leaflets; audiotapes and CDs; audio– visual DVDs; computer programmes and interactive websites; and structured discussions. Many are delivered in a combination of formats. They can be used before, during or after the clinical encounter. There has been a recent explosion in the number of decision aids covering screening investigations, surgical and non-surgical treatments in variety of specialties. Developers include a range of commercial, non-profit and academic organisations mainly, but not exclusively, in North America. The Cochrane inventory of decision aids (http://decisionaid.ohri.ca/cochinvent.php) includes more than 300 currently available tools covering a wide range of conditions. It is estimated that decision aids were accessed about nine million times in 2006, mainly online [11]. Knee OA is one of nine online decision aids currently available on the website of NHS Direct in England [12]. After using the decision aid, it is necessary to elicit and assess the patient's knowledge about the available options, their values regarding the risks and benefits, and ultimately their preferred choice [13]. Any unresolved issues and support required must also be highlighted. This information is captured in a “patient preference report”, which is in either paper or electronic format and is used by the clinical team to “close the decision loop” [14]. 4. Rationale for decision aids in knee arthroplasty Over 6 million people in the UK suffer from painful OA in one or both knees [15]. Knee replacement is a reliable and effective intervention for patients with significant persistent symptoms, functional limitations and reduced quality of life despite conservative therapy [16,17]. The National Joint Registry (NJR) for England and Wales reports that nearly 75,000 primary knee replacement procedures were conducted during 2010 for OA [18]. This represents about a 25% increase in the number of procedures reported during 2006. There are a number of challenges and concerns facing knee arthroplasty provision. These are briefly outlined below. 4.1. Unwarranted variation in service provision The NHS Atlas of Variation highlights considerable regional variations in knee arthroplasty provision [19,20]. This can be as high as four to five-fold between the highest and lowest rate areas. Some of the regional variation may reflect differences in consultation rates or in GPs' referral decisions. Rates of knee and hip arthroplasty in England have been shown to vary by “age, sex, deprivation, rurality, and ethnicity” [21]. However, what is more concerning is that the disparity does not reflect the variation in incidence, prevalence or severity of OA. National patient reported outcome measures (PROMs) data from England suggests that regions with the highest knee arthroplasty rates have the lowest pain and disability scores [20,22]. This has been cited as a reason for possible patient dissatisfaction and has led some to question the “healthcare value” of arthroplasty [23]. It has been suggested that patients may not have accepted surgery had they been given clear and unbiased information about the full range of treatment options and probabilities of benefit and harm. Regional variation may also relate to differences in clinical practice and decision-making of orthopaedic surgeons. Despite professional guidelines and recommendations, there is variability in the patient's journey from self-referral to primary care, through orthopaedic consultation to joint replacement [24,25]. Pain, disability and quality of life are multifaceted parameters that depend on the complex interaction of biological, psychological and social factors. These parameters
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do not necessarily correlate with physical findings or the extent of radiographic joint degeneration. Patient-reported scoring tools are used to supplement traditional clinical assessments in the surgeon's evaluation for joint replacement. However, there is debate about the extent to which such scoring systems should influence surgical decisions. There appears to be no consensus amongst surgeons for the definitive indications for knee replacement [26–28]. A recent Swedish study using a standardised indication criteria assessment tool for patients selected for primary hip or knee replacement surgery found significant variations between hospitals [28]. Patient factors such as age, obesity and co-morbidities have been shown to affect the surgeon's threshold to proceed to joint replacement [27,29]. 4.2. Patient satisfaction and selection The majority of patients that are selected for knee arthroplasty are pleased with their outcome. The rate of patient dissatisfaction reported in the literature ranges from 5% to 20%, with a generally quoted value of 10% [30–34]. NJR data from 8095 patients following total knee replacement states that 81.8% were satisfied, 11.2% were unsure and 7.0% were not satisfied [32]. PROMs data from England shows that 91.5% of patients record an improvement in their Oxford Knee Score following knee arthroplasty. However, 78.0% reported an improvement in their general health (EQ5D score) and only 49.5% reported an increase in general health as marked on a visual analogue scale (EQ5D VAS score) [35]. PROMs collected before and 3 months after primary knee replacement in 449 patients showed that 10% reported no change and 7.6% reported deterioration [36]. Such data raise questions about whether surgery is the best option for all patients, and whether knee replacements that conferred no patient benefit represent inefficient use of NHS resources. Potential reasons for dissatisfaction include unrealistic patient expectations and uninformed perceptions of potential benefits, risks and limitations of surgery [34]. Patients' own preferences and willingness to undergo joint replacement vary according to age, gender and ethnicity [37–39]. The growing group of patients diagnosed with OA at a younger (pre-retirement) age who have higher demands on their joints pose a unique challenge. The long-term results of arthroplasty are more unpredictable than in their older counterparts [40–45] and there is on-going debate on how best to measure outcome in younger patients [46]. The treatment of knee OA offers several “preference-sensitive” options, and the patient's values and attitudes to the risk–benefit profile of each available option are central to the decision [47,48]. A survey in Ontario, Canada found that only 15% of patients eligible for joint replacement surgery by radiographs and self-reported symptoms would agree to surgery if offered [49]. It is difficult to predict the patient's decision because the perceived risks, benefits and tradeoffs for treatments vary between individuals and also over time [50]. Decision aids improve patients' understanding of their choices in the treatment of OA and, therefore, allow better setting of expectations. Although no direct evidence exists, it is hoped decision aids could decrease dissatisfaction following arthroplasty. 4.3. Financial constraints The demand for primary knee arthroplasty is projected to rise by 673% by 2030 [51]. There are concerns on how this is going to be funded as health care providers find themselves in a challenging economic and political environment. The NHS budget has been ringfenced from austerity measures. However, an established and respected healthcare think tank, The King's Fund, predicts that the NHS faces an effective real terms budget cut of 5–6% per year, leaving an annual funding gap of up to £6 billion [52]. Their strategy to improve productivity targets clinical decision-making and the variations in clinical service delivery.
Shared evidence-based decision-making with the use of patient decision aids has been advocated as a potential solution to the above challenges facing knee arthroplasty provision, which can be extended to all elective orthopaedic procedures. This approach, once embedded into routine clinical care, is expected to improve patient satisfaction, equalise regional variations in arthroplasty rates and potentially reduce expenditure. [53]. 5. Effectiveness of decision aids A Cochrane Collaboration systematic review has evaluated the impact of patient decision aids across a number of dimensions [54]. Eighty-six completed randomised controlled trials (RCTs) were reviewed; evaluating 35 different clinical decisions. There were no completed decision aid trials in joint replacement surgery within the time frame of the review and only one suitable on-going RCT comparing decision aids versus usual care was identified. The only orthopaedic study included was a comparison of interactive videodisk plus booklet versus booklet alone in 393 adults with herniated discs or spinal stenosis considering back surgery [55]. There was a reduction in the uptake of surgery among patients with herniated discs that used the interactive videodisk without effecting functional outcomes. However, the authors reported little effect on patient satisfaction and functional status. The Cochrane review concluded that decision aids were better than usual care in terms of: 1. Improved patient knowledge 2. Improved patient perception of chances of risks and benefits 3. Less decisional conflict (i.e. fewer patients feel unclear about personal values or feel uninformed) 4. Fewer patients were passive in decision-making 5. Fewer patients remain undecided after using an aid 6. Greater concordance between patient values and chosen option The authors did not find a significant effect on patient's satisfaction or anxiety related to decision-making. The benefits generally concur with previous reviews and studies on decision aids (reviewed in [56]). The evidence to date has shown no overall effect on health outcomes (general or disease-specific) or patient adherence to the chosen treatment. There are variable effects on actual decisions made and longevity of the knowledge gain [54,56]. Research on decision aids has concentrated on the impact of decision aids on the patient as an individual. There are relatively few studies reporting effects on service utilisation and health care costs. The current Cochrane review reports reduced rates of elective invasive surgery by up to 25% in favour of conservative options. This could have huge cost-saving implications for health-care providers. However, there are currently only a handful of completed trials directly measuring the economic impact of decision aids. A recent UKbased multicentre RCT evaluated the effects of decision support in 894 women with heavy menstrual bleeding followed up for 2 years [57]. Where decision support was used, there was a significant reduction in surgery rates and an associated reduction in health care spending. Other economic evaluations found that decision aids produced no difference in health resource use and were only costneutral if cheaper online tools were used [58–61]. The effect of decision aids on consultation length is variable, ranging from 8 min shorter to 23 min longer [54]. However, 6 out the 9 RCTs reported no difference in consultation length. There are no studies investigating the effect of decision aids on litigation rates. Whether any these findings extrapolate to orthopaedic practice requires further investigation. 6. Accuracy and quality of decision aids The information contained within patient decision aids must be evidence-based, accurate and up-to-date. It must be presented in an
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understandable manner without bias. This is essential for patients to use and benefit from the aids, and for clinicians and health providers to incorporate them into routine practice. There has been a rapid growth in the number of decision aids in recent years produced by multiple developers from all over the world. A recent review of the information in decision aids raised some concerns regarding their “completeness, balance and accuracy” [62]. The authors found that only 43% of the 68 treatment decision aids reviewed described the natural history of the condition and only 54% described the procedures involved for each available option. A description of the benefits and risks was given in over 60% of aids and their likelihoods were described in about 65% of aids. About half of the decision aids had a greater emphasis on potential benefits than harms. Although designed to involve patients in decisionmaking, few aids sought patient input during development, favouring medical experts instead. Many decision aids included patient narratives and vignettes. People often find it easier to relate to another individual's experience than to statistical representations (i.e. the evidence-base). The use of such anecdotal evidence must be impartial and used with caution. The International Decision Aid Standards (IPDAS) Collaboration has subsequently been created and has established approved standards for developing and evaluating decision aids [63]. They have also produced a tool (IPDAS instrument) for assessing patient decision aids [64]. However, the cost of developing, assessing and maintaining the accuracy and quality of decision aids is not presently known.
7. Orthopaedic opinion and practice Orthopaedic surgeons are receptive to the use of patient decision aids to support shared decision-making. In survey of UK consultant orthopaedic surgeons who perform joint replacement surgery, 79% responded that the use of patient decision aids is a “good” or “excellent” idea [2]. Over half (53%) of the 272 responding surgeons preferred a booklet format, 5.9% preferred a DVD, 4.4% preferred a webbased online aid and 9.2% thought a combination of formats would be best. However, this seems to be at odds with the current interest in online decision aid tools by the NHS and health providers in North America. In the same survey, most surgeons (43%) favoured the “take home model” for decision aids. Patients use the aid after the first consultation so that options can be discussed and a decision made at the subsequent visit. The use of patient decision aids before the first consultation was preferred by 18% of respondents. Only 13% of surgeons would consider the use of decision aids during the consultation. The most important factors that would influence orthopaedic surgeons to use patient decision aids were if they improved patients' understanding (38% of respondents); helped communication with patients (25%), and helped patients clarify their priorities and values (15%). The most common concerns that would dissuade use were if outpatient workload was increased (23%); aids were not kept up-to-date (22%), and if patients did not like or want to use them (20%). Similar positive sentiments towards decision aids have been echoed by the American Academy of Hip and Knee Surgeons and the American Academy of Orthopaedic Surgeons (AAOS) [65]. AAOS spinal surgeons have highlighted the possibility that shared decisionmaking may reduce litigation and malpractice insurance premiums. Despite the support for the concept of patient decision aids, they have not yet entered routine orthopaedic practice. In addition to the factors voiced by UK surgeons given above, other obstacles to uptake include concerns about accuracy, applicability to older patients, language barriers for patients from different ethnic backgrounds and literacy levels, and usability of media formats. There are arguments that the cost-effectiveness of decision aids remains inconclusive and fears
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that both private and NHS providers may lose income if fewer patients choose surgery. 8. Conclusions There is a strong ethical, political and economic drive for shared decision-making in elective orthopaedic surgery. Patient decision aids facilitate shared decision-making and have been shown to improve patients' knowledge and perceptions on the risk–benefit profile of available treatment options. They better align patients' values with clinical decisions and there is emerging evidence that decision aids improve the efficiency of service utilisation and health care costs. Surveys suggest that orthopaedic surgeons are amenable to the principle of shared decision-making, but have concerns regarding their logistics, practicality and implementation. In particular, decision support must not interfere with or burden the clinical workflow. Further research is required to evaluate the true impact of decision aids on the actual decisions made, service utilisation and health care costs, and which format is best. Methods to incentivise private and NHS providers to use patient decision aids in routine clinical practice are being developed. Shared decision-making is already deemed to be the most ethical way to make treatment decisions and it may soon become a legal standard in some countries and a pre-requisite for informed consent [11,65]. The number of available patient decision aids is growing rapidly and the infrastructure for their development, assessment and dissemination is being established, particularly in the USA and Canada. The government wants the NHS to adopt the ethos of shared-decision making at its core, and patient decision aids are beginning to enter routine practice in other specialties such as Urology and Obstetrics. NHS Direct is already offering online decision aids for knee and hip OA. It is likely that shared decision-making and patient decision aids will enter all areas of elective Orthopaedics. As surgeons we need to play an integral role in the development of decision aids and their adaptation to clinical practice. Author contributions All co-authors have made substantial contributions to the conception and planning of the review, drafting and revising the article for important intellectual content and final approval of the version to be submitted. Funding sources This work was supported by the NIHR Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford. Additional sources of funding include Orthopaedic Research UK (Chethan Jayadev) and Smith & Nephew (Tanvir Khan). Other than their support and encouragement, the funding sources above had no involvement in the design or execution of the review, in the preparation of the manuscript or the decision to submit this work for publication. Conflict of interest statement No author has any financial or personal relationships with other people or organisations that could inappropriately influence their work. References [1] Department of Health. Equity and Excellence: Liberating the NHS. Available from: http://www.dh.gov.uk/en/Healthcare/LiberatingtheNHS/ 2010. [2] Adam JA, Khaw FM, Thomson RG, Gregg PJ, Llewellyn-Thomas HA. Patient decision aids in joint replacement surgery: a literature review and an opinion survey of consultant orthopaedic surgeons. Ann R Coll Surg Engl 2008 Apr;90(3):198–207.
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N Engl J Med 2000 Apr 6;342(14):1016–22. Coyte PC, Hawker G, Croxford R, Wright JG. Rates of revision knee replacement in Ontario, Canada. J Bone Joint Surg Am 1999 Jul 01;81(6):773–82. Furnes O, Espehaug B, Lie S, Vollset S, Engesæter L, Havelin L. Early failures among 7,174 primary total knee replacements: a follow-up study from the Norwegian Arthroplasty Register 1994–2000. Acta Orthop Scand 2002 Feb 01;73(2):117–29. Gioe T, Novak C, Sinner P, Ma W. Knee arthroplasty in the young patient: survival in a community registry. Clin Orthop Relat Res 2007 Nov;464:83–7. Lonner JH, Hershman S, Mont M, Lotke PA. Total knee arthroplasty in patients 40 years of age and younger with osteoarthritis. Clin Orthop Relat Res 2000 Nov;01(380):85–90. Rand JA, Trousdale RT, Ilstrup DM, Harmsen WS. Factors affecting the durability of primary total knee prostheses. J Bone Joint Surg Am 2003 Mar 01;85-A(2):259–65. Vazquez-Vela Johnson G, Worland RL, Keenan J, Norambuena N. Patient demographics as a predictor of the ten-year survival rate in primary total knee replacement. J Bone Joint Surg Br 2003 Feb 01;85(1):52–6. Price AJ, Longino D, Rees J, Rout R, Pandit H, Javaid K. Are pain and function better measures of outcome than revision rates after TKR in the younger patient? Knee 2010 Jun;17(3):196–9 [Research Support, Non-U.S. Gov't]. Kassirer JP. Incorporating patients' preferences into medical decisions. N Engl J Med 1994 Jun 30;330(26):1895–6. Pickering Institute Europe. Sharing Decisions. Available from: http://www. pickereurope.org/sharingdecisions 26 October 2010. Hawker GA, Wright JG, Coyte PC, Williams JI, Harvey B, Glazier R, et al. Determining the need for hip and knee arthroplasty: the role of clinical severity and patients' preferences. Med Care 2001 Mar;39(3):206–16. Clark JP, Hudak PL, Hawker GA, Coyte PC, Mahomed NN, Kreder HJ. The moving target: a qualitative study of elderly patients' decision-making regarding total joint replacement surgery. J Bone Joint Surg Am 2004 Jul 1;86-A(7):1366–74. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am 2007 Apr;89(4):780–5. Appleby J, Ham C, Imison C, Jennings M. Improving NHS Productivity: More with the Same Not More of the Same: The Kings Fund; 2010. Right Care. QIPP. Available from: http://www.dh.gov.uk/en/Healthcare/Quality andproductivity/QIPPworkstreams/DH_115449. Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2011(10):CD001431 [Meta-Analysis Review]. Deyo RA, Cherkin DC, Weinstein J, Howe J, Ciol M, Mulley Jr AG. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Med Care 2000 Sep;38(9):959–69. Leatherman S, Warrick L. Effectiveness of decision aids: a review of the evidence. Med Care Res Rev 2008 Dec 1;65(6 Suppl):79S–116S. Kennedy AD, Sculpher MJ, Coulter A, Dwyer N, Rees M, Abrams KR, et al. Effects of decision aids for menorrhagia on treatment choices, health outcomes, and costs: a randomized controlled trial. JAMA 2002 Dec 4;288(21):2701–8. Murray E, Davis H, Tai SS, Coulter A, Gray A, Haines A. Randomised controlled trial of an interactive multimedia decision aid on benign prostatic hypertrophy in primary care. BMJ 2001 Sep 1;323(7311):493–6. Murray E, Davis H, Tai SS, Coulter A, Gray A, Haines A. Randomised controlled trial of an interactive multimedia decision aid on hormone replacement therapy in primary care. BMJ 2001 Sep 1;323(7311):490–3. Vuorma S, Rissanen P, Aalto AM, Hurskainen R, Kujansuu E, Teperi J. Impact of patient information booklet on treatment decision — a randomized trial among women with heavy menstruation. Health Expect 2003 Dec;6(4):290–7. Vuorma S, Teperi J, Aalto AM, Hurskainen R, Kujansuu E, Rissanen P. A randomized trial among women with heavy menstruation — impact of a decision aid on treatment outcomes and costs. Health Expect 2004 Dec;7(4):327–37. Feldman-Stewart D, Brennenstuhl S, McIssac K, Austoker J, Charvet A, Hewitson P, et al. A systematic review of information in decision aids. Health Expect 2007 Mar 1;10(1):46–61. Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, et al. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ 2006 Aug 26;333(7565):417. International Decision Aid Standards Collaboration. IPDASi Assessment. Available from: http://www.ipdasi.org/. Weinstein JN, Clay K, Morgan TS. Informed patient choice: patient-centered valuing of surgical risks and benefits. Health Aff (Millwood) 2007 May-Jun;26(3): 726–30.
Contents lists available at SciVerse ScienceDirect
The Knee
Review
Patient decision aids in knee replacement surgery Chethan Jayadev a, Tanvir Khan a, Angela Coulter b, c, David J. Beard a, Andrew J. Price a,⁎ a b c
NIHR Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Science, University of Oxford, United Kingdom Foundation for Informed Medical Decision Making, Boston, Massachusetts, USA Department of Public Health, University of Oxford, United Kingdom
a r t i c l e
i n f o
Article history: Received 12 September 2011 Received in revised form 5 February 2012 Accepted 7 February 2012 Keywords: Decision aids Shared decision-making Arthroplasty Knee replacement surgery
a b s t r a c t Arthroplasty is an effective intervention for symptomatic knee osteoarthritis refractory to conservative therapy. However, recent data highlights regional variations in service provision unrelated to disease severity and a low, but not insignificant, rate of patient dissatisfaction. The variation in knee arthroplasty provision is in part also due to the clinical decision-making of orthopaedic surgeons. The management of osteoarthritis is an example of a preference-sensitive clinical pathway, and possible explanations for poor patient satisfaction include unrealistic expectations and poor perception of potential benefits and risks. In addition to the individual impact, this represents an inefficient use of resources by healthcare providers during a challenging economic period. Improved shared-decision making between patients and clinicians would potentially address these issues. Patient decision aids provide relevant personalised evidence-based information to facilitate the shared decision-making process. Orthopaedic surgeons are receptive to the use of patient decision aids to support shared decision-making, but there are a number of issues to overcome before they are routinely adopted. The number of decision aids and the literature supporting their effectiveness is growing rapidly. NHS Direct has launched online patient decision support for knee osteoarthritis. The use of patient decision aids in clinical practice is gathering pace and may soon become the ethical and legal standard. This article provides a narrative review of patient decision aids in the context of knee replacement surgery from a UK perspective. © 2012 Elsevier B.V. All rights reserved.
Contents 1. 2. 3. 4.
Introduction . . . . . . . . . . . . . . . . . . Shared decision-making . . . . . . . . . . . . Patient decision aids . . . . . . . . . . . . . . Rationale for decision aids in knee arthroplasty . 4.1. Unwarranted variation in service provision 4.2. Patient satisfaction and selection . . . . . 4.3. Financial constraints . . . . . . . . . . . 5. Effectiveness of decision aids . . . . . . . . . . 6. Accuracy and quality of decision aids . . . . . . 7. Orthopaedic opinion and practice . . . . . . . . 8. Conclusions . . . . . . . . . . . . . . . . . . Author contributions . . . . . . . . . . . . . . . . Funding sources . . . . . . . . . . . . . . . . . . Conflict of interest statement . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . .
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1. Introduction ⁎ Corresponding author at: Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, Botnar Research Centre, Windmill Road, Oxford OX3 7LD, United Kingdom. Tel.: + 44 1865 737539; fax: + 44 1865 227671. E-mail address: [email protected] (A.J. Price). 0968-0160/$ – see front matter © 2012 Elsevier B.V. All rights reserved. doi:10.1016/j.knee.2012.02.001
Patient decision aids are tools designed to help patients make difficult decisions about their investigations and treatments. They are used in preference-sensitive health care choices; where there is
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more than one way to treat a condition with no clinical evidence to suggest one option is better than another. Decision aids help patients in deciding which of the available options will be best for them. The National Health Service (NHS) is being remodelled to give patients “more choice and control, backed by an information revolution” [1]. The principle is “no decisions about me without me”. NHS Direct already offers online decision aids for knee and hip osteoarthritis. Orthopaedic surgeons are receptive to the use of patient decision aids to support shared decision-making. In a survey of UK consultant orthopaedic surgeons who perform joint replacement surgery, 79% responded that the use of patient decision aids is a “good” or “excellent” idea [2]. The aim of this article is to provide on overview of patient decision aids with the context and rationale for their emerging use in knee arthroplasty. 2. Shared decision-making Patients want greater involvement in decisions regarding their care. Up to 75% of patients believe that treatment decisions should be made by them alone, or together with their doctor [3]. Consequently, it has been argued that the doctor–patient relationship should shift from paternalism to a partnership [4]. This is reflected in ethical guidance for doctors produced by the General Medical Council [5]. Like any good partnership confronted with a difficult choice, a mutual understanding of needs and expectations is required to make a shared decision with shared responsibility. Shared decision-making requires collaboration between the patient and clinician to reach an informed decision on the most appropriate course of action. This is based on the best available clinical evidence and the patient's needs, priorities, perceptions and values [6,7]. The practice of shared decision-making is most apt for preference-sensitive health care choices such as arthroplasty for osteoarthritis (OA). There are several reasonable possible actions and each option has its own risk–benefit profile. The objective is that the agreed management plan is consistent with the patient's values. The model is rapidly becoming the established ethical, political and professional paradigm [8]. The NHS has promised that “shared decision-making will become the norm” [1]. Patients should always make the ultimate decision about their care and this is manifest in their right to autonomy, requirement to consent and adherence (or not) to the care plan. However, if they are not fully informed about the options and encouraged to participate, they cannot be autonomous decision makers. Some prefer the term informed decision-making, in contrast to the more passive notion of informed consent, as this crystallises the essence of the approach [9]. There is a bi-directional exchange of information. The clinician must convey their expertise on diagnosis, prognosis, and treatment options with their effectiveness, benefits and potential risks. The patient must assimilate this information to identify and communicate their personal priorities, attitudes and values to the risk–benefit profile of each option. The subsequent agreement on the management plan is based on this exchange. 3. Patient decision aids Patient decision aids are tools that provide patients with the relevant evidence-based information to facilitate the shared decisionmaking process. They provide estimates of the benefits and risks of the available options in sufficient detail to allow patients to weigh up the pros and cons and make specific personal choices about treatment. They are an adjunct to the doctor–patient encounter and not a substitute. The aims of using decision aids are to [10]: 1. Enhance patients' knowledge of the available treatment or management options, quantifying their risks, benefits and likelihoods.
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2. Help clarify expectations, perceptions, priorities and values. 3. Engage patients in the decision making process and offer structured guidance in deliberation. Decision aids can be self- or clinician administered. They exist in multiple formats: booklets and leaflets; audiotapes and CDs; audio– visual DVDs; computer programmes and interactive websites; and structured discussions. Many are delivered in a combination of formats. They can be used before, during or after the clinical encounter. There has been a recent explosion in the number of decision aids covering screening investigations, surgical and non-surgical treatments in variety of specialties. Developers include a range of commercial, non-profit and academic organisations mainly, but not exclusively, in North America. The Cochrane inventory of decision aids (http://decisionaid.ohri.ca/cochinvent.php) includes more than 300 currently available tools covering a wide range of conditions. It is estimated that decision aids were accessed about nine million times in 2006, mainly online [11]. Knee OA is one of nine online decision aids currently available on the website of NHS Direct in England [12]. After using the decision aid, it is necessary to elicit and assess the patient's knowledge about the available options, their values regarding the risks and benefits, and ultimately their preferred choice [13]. Any unresolved issues and support required must also be highlighted. This information is captured in a “patient preference report”, which is in either paper or electronic format and is used by the clinical team to “close the decision loop” [14]. 4. Rationale for decision aids in knee arthroplasty Over 6 million people in the UK suffer from painful OA in one or both knees [15]. Knee replacement is a reliable and effective intervention for patients with significant persistent symptoms, functional limitations and reduced quality of life despite conservative therapy [16,17]. The National Joint Registry (NJR) for England and Wales reports that nearly 75,000 primary knee replacement procedures were conducted during 2010 for OA [18]. This represents about a 25% increase in the number of procedures reported during 2006. There are a number of challenges and concerns facing knee arthroplasty provision. These are briefly outlined below. 4.1. Unwarranted variation in service provision The NHS Atlas of Variation highlights considerable regional variations in knee arthroplasty provision [19,20]. This can be as high as four to five-fold between the highest and lowest rate areas. Some of the regional variation may reflect differences in consultation rates or in GPs' referral decisions. Rates of knee and hip arthroplasty in England have been shown to vary by “age, sex, deprivation, rurality, and ethnicity” [21]. However, what is more concerning is that the disparity does not reflect the variation in incidence, prevalence or severity of OA. National patient reported outcome measures (PROMs) data from England suggests that regions with the highest knee arthroplasty rates have the lowest pain and disability scores [20,22]. This has been cited as a reason for possible patient dissatisfaction and has led some to question the “healthcare value” of arthroplasty [23]. It has been suggested that patients may not have accepted surgery had they been given clear and unbiased information about the full range of treatment options and probabilities of benefit and harm. Regional variation may also relate to differences in clinical practice and decision-making of orthopaedic surgeons. Despite professional guidelines and recommendations, there is variability in the patient's journey from self-referral to primary care, through orthopaedic consultation to joint replacement [24,25]. Pain, disability and quality of life are multifaceted parameters that depend on the complex interaction of biological, psychological and social factors. These parameters
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do not necessarily correlate with physical findings or the extent of radiographic joint degeneration. Patient-reported scoring tools are used to supplement traditional clinical assessments in the surgeon's evaluation for joint replacement. However, there is debate about the extent to which such scoring systems should influence surgical decisions. There appears to be no consensus amongst surgeons for the definitive indications for knee replacement [26–28]. A recent Swedish study using a standardised indication criteria assessment tool for patients selected for primary hip or knee replacement surgery found significant variations between hospitals [28]. Patient factors such as age, obesity and co-morbidities have been shown to affect the surgeon's threshold to proceed to joint replacement [27,29]. 4.2. Patient satisfaction and selection The majority of patients that are selected for knee arthroplasty are pleased with their outcome. The rate of patient dissatisfaction reported in the literature ranges from 5% to 20%, with a generally quoted value of 10% [30–34]. NJR data from 8095 patients following total knee replacement states that 81.8% were satisfied, 11.2% were unsure and 7.0% were not satisfied [32]. PROMs data from England shows that 91.5% of patients record an improvement in their Oxford Knee Score following knee arthroplasty. However, 78.0% reported an improvement in their general health (EQ5D score) and only 49.5% reported an increase in general health as marked on a visual analogue scale (EQ5D VAS score) [35]. PROMs collected before and 3 months after primary knee replacement in 449 patients showed that 10% reported no change and 7.6% reported deterioration [36]. Such data raise questions about whether surgery is the best option for all patients, and whether knee replacements that conferred no patient benefit represent inefficient use of NHS resources. Potential reasons for dissatisfaction include unrealistic patient expectations and uninformed perceptions of potential benefits, risks and limitations of surgery [34]. Patients' own preferences and willingness to undergo joint replacement vary according to age, gender and ethnicity [37–39]. The growing group of patients diagnosed with OA at a younger (pre-retirement) age who have higher demands on their joints pose a unique challenge. The long-term results of arthroplasty are more unpredictable than in their older counterparts [40–45] and there is on-going debate on how best to measure outcome in younger patients [46]. The treatment of knee OA offers several “preference-sensitive” options, and the patient's values and attitudes to the risk–benefit profile of each available option are central to the decision [47,48]. A survey in Ontario, Canada found that only 15% of patients eligible for joint replacement surgery by radiographs and self-reported symptoms would agree to surgery if offered [49]. It is difficult to predict the patient's decision because the perceived risks, benefits and tradeoffs for treatments vary between individuals and also over time [50]. Decision aids improve patients' understanding of their choices in the treatment of OA and, therefore, allow better setting of expectations. Although no direct evidence exists, it is hoped decision aids could decrease dissatisfaction following arthroplasty. 4.3. Financial constraints The demand for primary knee arthroplasty is projected to rise by 673% by 2030 [51]. There are concerns on how this is going to be funded as health care providers find themselves in a challenging economic and political environment. The NHS budget has been ringfenced from austerity measures. However, an established and respected healthcare think tank, The King's Fund, predicts that the NHS faces an effective real terms budget cut of 5–6% per year, leaving an annual funding gap of up to £6 billion [52]. Their strategy to improve productivity targets clinical decision-making and the variations in clinical service delivery.
Shared evidence-based decision-making with the use of patient decision aids has been advocated as a potential solution to the above challenges facing knee arthroplasty provision, which can be extended to all elective orthopaedic procedures. This approach, once embedded into routine clinical care, is expected to improve patient satisfaction, equalise regional variations in arthroplasty rates and potentially reduce expenditure. [53]. 5. Effectiveness of decision aids A Cochrane Collaboration systematic review has evaluated the impact of patient decision aids across a number of dimensions [54]. Eighty-six completed randomised controlled trials (RCTs) were reviewed; evaluating 35 different clinical decisions. There were no completed decision aid trials in joint replacement surgery within the time frame of the review and only one suitable on-going RCT comparing decision aids versus usual care was identified. The only orthopaedic study included was a comparison of interactive videodisk plus booklet versus booklet alone in 393 adults with herniated discs or spinal stenosis considering back surgery [55]. There was a reduction in the uptake of surgery among patients with herniated discs that used the interactive videodisk without effecting functional outcomes. However, the authors reported little effect on patient satisfaction and functional status. The Cochrane review concluded that decision aids were better than usual care in terms of: 1. Improved patient knowledge 2. Improved patient perception of chances of risks and benefits 3. Less decisional conflict (i.e. fewer patients feel unclear about personal values or feel uninformed) 4. Fewer patients were passive in decision-making 5. Fewer patients remain undecided after using an aid 6. Greater concordance between patient values and chosen option The authors did not find a significant effect on patient's satisfaction or anxiety related to decision-making. The benefits generally concur with previous reviews and studies on decision aids (reviewed in [56]). The evidence to date has shown no overall effect on health outcomes (general or disease-specific) or patient adherence to the chosen treatment. There are variable effects on actual decisions made and longevity of the knowledge gain [54,56]. Research on decision aids has concentrated on the impact of decision aids on the patient as an individual. There are relatively few studies reporting effects on service utilisation and health care costs. The current Cochrane review reports reduced rates of elective invasive surgery by up to 25% in favour of conservative options. This could have huge cost-saving implications for health-care providers. However, there are currently only a handful of completed trials directly measuring the economic impact of decision aids. A recent UKbased multicentre RCT evaluated the effects of decision support in 894 women with heavy menstrual bleeding followed up for 2 years [57]. Where decision support was used, there was a significant reduction in surgery rates and an associated reduction in health care spending. Other economic evaluations found that decision aids produced no difference in health resource use and were only costneutral if cheaper online tools were used [58–61]. The effect of decision aids on consultation length is variable, ranging from 8 min shorter to 23 min longer [54]. However, 6 out the 9 RCTs reported no difference in consultation length. There are no studies investigating the effect of decision aids on litigation rates. Whether any these findings extrapolate to orthopaedic practice requires further investigation. 6. Accuracy and quality of decision aids The information contained within patient decision aids must be evidence-based, accurate and up-to-date. It must be presented in an
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understandable manner without bias. This is essential for patients to use and benefit from the aids, and for clinicians and health providers to incorporate them into routine practice. There has been a rapid growth in the number of decision aids in recent years produced by multiple developers from all over the world. A recent review of the information in decision aids raised some concerns regarding their “completeness, balance and accuracy” [62]. The authors found that only 43% of the 68 treatment decision aids reviewed described the natural history of the condition and only 54% described the procedures involved for each available option. A description of the benefits and risks was given in over 60% of aids and their likelihoods were described in about 65% of aids. About half of the decision aids had a greater emphasis on potential benefits than harms. Although designed to involve patients in decisionmaking, few aids sought patient input during development, favouring medical experts instead. Many decision aids included patient narratives and vignettes. People often find it easier to relate to another individual's experience than to statistical representations (i.e. the evidence-base). The use of such anecdotal evidence must be impartial and used with caution. The International Decision Aid Standards (IPDAS) Collaboration has subsequently been created and has established approved standards for developing and evaluating decision aids [63]. They have also produced a tool (IPDAS instrument) for assessing patient decision aids [64]. However, the cost of developing, assessing and maintaining the accuracy and quality of decision aids is not presently known.
7. Orthopaedic opinion and practice Orthopaedic surgeons are receptive to the use of patient decision aids to support shared decision-making. In survey of UK consultant orthopaedic surgeons who perform joint replacement surgery, 79% responded that the use of patient decision aids is a “good” or “excellent” idea [2]. Over half (53%) of the 272 responding surgeons preferred a booklet format, 5.9% preferred a DVD, 4.4% preferred a webbased online aid and 9.2% thought a combination of formats would be best. However, this seems to be at odds with the current interest in online decision aid tools by the NHS and health providers in North America. In the same survey, most surgeons (43%) favoured the “take home model” for decision aids. Patients use the aid after the first consultation so that options can be discussed and a decision made at the subsequent visit. The use of patient decision aids before the first consultation was preferred by 18% of respondents. Only 13% of surgeons would consider the use of decision aids during the consultation. The most important factors that would influence orthopaedic surgeons to use patient decision aids were if they improved patients' understanding (38% of respondents); helped communication with patients (25%), and helped patients clarify their priorities and values (15%). The most common concerns that would dissuade use were if outpatient workload was increased (23%); aids were not kept up-to-date (22%), and if patients did not like or want to use them (20%). Similar positive sentiments towards decision aids have been echoed by the American Academy of Hip and Knee Surgeons and the American Academy of Orthopaedic Surgeons (AAOS) [65]. AAOS spinal surgeons have highlighted the possibility that shared decisionmaking may reduce litigation and malpractice insurance premiums. Despite the support for the concept of patient decision aids, they have not yet entered routine orthopaedic practice. In addition to the factors voiced by UK surgeons given above, other obstacles to uptake include concerns about accuracy, applicability to older patients, language barriers for patients from different ethnic backgrounds and literacy levels, and usability of media formats. There are arguments that the cost-effectiveness of decision aids remains inconclusive and fears
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that both private and NHS providers may lose income if fewer patients choose surgery. 8. Conclusions There is a strong ethical, political and economic drive for shared decision-making in elective orthopaedic surgery. Patient decision aids facilitate shared decision-making and have been shown to improve patients' knowledge and perceptions on the risk–benefit profile of available treatment options. They better align patients' values with clinical decisions and there is emerging evidence that decision aids improve the efficiency of service utilisation and health care costs. Surveys suggest that orthopaedic surgeons are amenable to the principle of shared decision-making, but have concerns regarding their logistics, practicality and implementation. In particular, decision support must not interfere with or burden the clinical workflow. Further research is required to evaluate the true impact of decision aids on the actual decisions made, service utilisation and health care costs, and which format is best. Methods to incentivise private and NHS providers to use patient decision aids in routine clinical practice are being developed. Shared decision-making is already deemed to be the most ethical way to make treatment decisions and it may soon become a legal standard in some countries and a pre-requisite for informed consent [11,65]. The number of available patient decision aids is growing rapidly and the infrastructure for their development, assessment and dissemination is being established, particularly in the USA and Canada. The government wants the NHS to adopt the ethos of shared-decision making at its core, and patient decision aids are beginning to enter routine practice in other specialties such as Urology and Obstetrics. NHS Direct is already offering online decision aids for knee and hip OA. It is likely that shared decision-making and patient decision aids will enter all areas of elective Orthopaedics. As surgeons we need to play an integral role in the development of decision aids and their adaptation to clinical practice. Author contributions All co-authors have made substantial contributions to the conception and planning of the review, drafting and revising the article for important intellectual content and final approval of the version to be submitted. Funding sources This work was supported by the NIHR Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford. Additional sources of funding include Orthopaedic Research UK (Chethan Jayadev) and Smith & Nephew (Tanvir Khan). Other than their support and encouragement, the funding sources above had no involvement in the design or execution of the review, in the preparation of the manuscript or the decision to submit this work for publication. Conflict of interest statement No author has any financial or personal relationships with other people or organisations that could inappropriately influence their work. References [1] Department of Health. Equity and Excellence: Liberating the NHS. Available from: http://www.dh.gov.uk/en/Healthcare/LiberatingtheNHS/ 2010. [2] Adam JA, Khaw FM, Thomson RG, Gregg PJ, Llewellyn-Thomas HA. Patient decision aids in joint replacement surgery: a literature review and an opinion survey of consultant orthopaedic surgeons. Ann R Coll Surg Engl 2008 Apr;90(3):198–207.
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