Developing a minimum standard of care for treating people with osteoarthritis of the hip and knee

We reviewed three recently published guidelines for the management of osteoarthritis (OA) and considered the evidence and potential for implementation. From this we propose a minimum standard of care, or a ‘core set’ of interventions, that should be offered to all patients with OA of the hip and/or knee. Eight core recommendations emerged where it is recommended that health-care professionals:

•

Provide advice about, and offer access to appropriate information for OA self-management and lifestyle change
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Provide advice about weight loss if patient is overweight or obese and refer to services as required
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Provide advice for land-based exercises incorporating aerobic and strengthening components and refer to services as required
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Recommend adequate paracetamol for pain relief
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Make patients aware that non-steroid anti-inflammatory drugs (NSAIDs) or coxibs can improve symptoms in majority but this comes with potential for harm and that risk potential varies – be aware of and minimise the individual’s risk potential
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Offer intra-articular steroids for short-term relief of a flare or acute deterioration in symptoms.
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Offer stronger analgesic relief if prolonged severe symptoms
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Offer access to assessment for arthroplasty for consumers with severe symptomatic OA not responding to conservative therapy

An integrated, chronic disease model of care is proposed to best implement OA management and a check list of clinical indicators/performance measures is provided.

Introduction

In 1966, Donabedian proposed that health-care quality be measured by considering the structure, the process and the outcomes of care . This article considers these aspects of health care for people with osteoarthritis (OA).

The article firstly, briefly outlines the several key international guidelines that have published recommendations for evidence-based best practice for management of OA knee and hip in 2008 and 2009. The most recently available are:

1.

OA Research Society International (OARSI) recommendations for the management of hip and knee OA, Part II: OARSI evidence-based, expert consensus guidelines. OARSI (2008)
2.

OA: national clinical guideline for care and management in adults. National Institute of Clinical Excellence ((NICE) (2008)
3.

Guideline for the non-surgical management of hip and knee OA, Royal Australian College of General Practice (RACGP) (2009)

Consensus and discordance between guideline recommendations are presented, and key recommendations discussed in relation to the following features; the grade of the published evidence; how explicit the recommendation is and the ease with which it could be implemented; other potential barriers to implementation from the perspective of the health professionals, the patients and the health system/society; and a potential research agenda to address knowledge gaps.

Secondly, we discuss evidence for lack of guideline implementation and ways in which health-care policy and service design can support guideline implementation.

Based on this review, we propose a minimum ‘core set’ of recommendations that should be implemented in practice and can be used to measure clinical performance in OA management. Finally, we provide implementation tools that could support clinicians and consumers to adopt and sustain implementation of the ‘core set’ guideline recommendations, including key performance indicators linked to the core set.

Given the increasing focus on patient-centred quality and safety of care, and given the identified gaps in implementing evidence into practice, key clinical performance indicators will be linked to these recommendations to guide health practitioners and consumers.

What do the guidelines tell us to do at the clinical practice level?

Table 1 outlines the key recommendations across the three summary guidelines.

Table 1

OA guideline recommendations for model and service components of care.

Guidelines	RACGP (Australia) 2009	NICE (UK) 2008	OARSI 2008
Overall model of care	Yes	Yes	None
*General recommendations*
GP education	✓	–	–
Patient information and education	✓	✓	✓*
Performing intra-articular injection	✓	–	–
Multidisciplinary care	✓	✓	–
Optimal management with combination therapy (non-pharmacological and pharmacological)	✓	✓	✓

Components of care
*Assessment and monitoring*
Clinical assessment: Joint signs and symptoms	✓	✓	–
Co-morbidities assessment	✓	✓	–
Psychosocial assessment	✓	✓	–
Falls risk assessment	✓	✓	–
Medication and non-steroid anti-inflammatory drugs (NSAIDs) risk assessment	✓	✓	–
Development of care plan	✓	✓	–
Periodic review	–	✓	–
*Non-pharmacological interventions*
Weight reduction	✓**	✓*	✓*
Exercise
Land-based exercise	✓**	✓*	✓* (knee)
Aquatic exercise	✓	✓**	✓**(hip)
Physical therapy-multimodal	✓	–	✓
Tai-chi	✓	–	–
Self-management education programme	✓	✓*	–
Thermotherapy	✓	✓*	✓*
Transcutaneous Electric Nerve Stimulation (TENS)	✓*	✓	✓*
Acupuncture	✓*	✓#	✓*
Patellar taping	✓	✓	–
Braces and orthoses	✓**#	✓*	✓*
Massage therapy	✓	–	–
Telephone support	✓	–	✓*
Magnetic bracelets	✓	–	–
Laser therapy	✓	✓*	–
Leech therapy	✓		–
Electromagnetic fields (pulsed electromagnetic fields or electrical stimulation)	✓**#	✓*	–
Therapeutic ultrasound	✓#	✓*	–
Social support	✓#	✓	–
Walking aids	–	✓**	✓
*Pharmacological interventions*
Paracetamol	✓*	✓*	✓* (knee) ✓ (hip)
Oral NSAIDs
Efficacy	✓**	✓*	✓*
Safety	✓**	✓*	✓
Weak and strong opioids	✓*	✓*	✓*
Intra-articular corticosteroid injection	✓**	✓*	✓* (knee) ✓** (hip)
Topical NSAIDs	✓	✓*	✓*
Topical capsaicin	✓	✓**	✓*
Topical rubefacients	–	✓#	–
Viscosupplementation (hyaluronan and hylan derivatives)	✓#	✓#	✓*
Glucosamine (hydrochloride and sulphate)	✓	✓#	✓**
Chondroitin sulphate	✓#	✓#	✓**
Vitamin, herbal and other dietary therapies	✓#	–	–

* indicates grade of recommendation A or level I.

**indicates grade of recommendation B or Level II.

✓ indicates this item was included.

– indicates the item was not included.

# indicates not recommended or have evidence of no benefit.

Each guideline group have performed a synthesis of previously published guidelines, a systematic review of more recently published data and then draw on a blend of evidence and expert consensus to make their recommendations. Each have been developed with great rigour and thus, to allow sufficient processing of the available evidence, close dates for literature searching were set at December 2006, April 2007 and July 2007, respectively. Therein lays a key problem with guidelines, as there have been numerous OA interventions published since that time. Using PubMed Clinical Queries search engine for randomised controlled trials (RCTs) for OA management, more than 90 papers evaluating non-surgical interventions for either hip or knee OA were identified from January 2008 and up to September 2009. For some interventions, more recent evidence are reviewed; however, this review does not attempt to systematically update the literature for all recommendations.

All guidelines follow the earlier European League Against Rheumatism (EULAR) ‘Guidelines for Management of OA’ framework and have a common theme to recommend a multi-modal approach for OA combining non-pharmacological and pharmacological interventions and although not specifically stated as such, apart from RACGP OA guidelines, this aligns with the principles of chronic disease management recommended by the Institute of Medicine (2001) in the report: ‘Crossing the Quality Chasm: A New Health System for the 21st Century’ . These principles and their translation into the primary care service model are discussed later in this article.

There are increasing expectations from consumers and regulatory bodies for explicit standard setting and performance measurement from health-care settings and health-care professionals . Whilst the focus to date has been largely directed towards institutional performance, there is increasing interest in understanding performance for management of priority conditions and health-care providers .

Based on epidemiological data and impact of the condition, OA is a priority condition and this has been formally recognised within the World Health Organisation (WHO) led Bone and Joint Decade initiative . However, international consensus on a core set of OA interventions, which may represent a minimum standard of care, is yet to be reached.

OARSI guidelines present a core set of 20 (12 non-pharmacological and 8 pharmacological) interventions based on a review of the available published guidelines, levels of evidence and expert consensus. Not all recommendations carried the same evidence rating but have been suggested as core based predominantly on whether they had been recommended by the majority of previously published guidelines. Despite a considerable variability in the strength of their recommendations, the implication of a core set is, they have equal importance. OARSI guidelines did provide a strength of recommendation (SOR) as a mean with 95% confidence interval for each intervention based on the opinions of the guideline development group after taking into consideration the evidence for efficacy, safety and cost-effectiveness and the experts’ experiences and perceptions of patients’ uptake of the recommendation.

The summary of the NICE guidelines presents a three-ring ‘onion-graph’ with a total of 16 recommendations (three non-pharmacological, including weight reduction, exercise and education in the ‘inner’ core; paracetamol and topical NSAIDs in the next ring and 11 interventions in the outer ring). Although no explicit method has been stated, the NICE guidelines appear to recommend the prioritised rankings based on a combination of benefits and harms and cost-effectiveness from the perspective of the National Health Service (NHS), who had commissioned the guideline and in so-doing have ranked NSAID use, for which there is a high grade of evidence for not only relief of symptoms but also risk of harm and considerable cost, alongside application of heat or ice for which there is very little evidence but low risk of harm and no cost to the NHS.

The RACGP guidelines do not address the ‘core-set’ issue and present 16 recommendations (nine non-pharmacological and seven pharmacological) but do address the minimum set of standards and key clinical indicators for monitoring patients with OA. The RACGP guideline working group comprised consumers, specialists and primary-care clinicians as it was determined that the key end-users of guidelines for the management of OA should be at the primary-care level. The group rated evidence according to the Australian National Health and Medical Research Council (NHMRC) recent recommendations for grading of evidence which attempts to make explicit all the components that OARSI were addressing implicitly.

The following tables ( Tables 2 and 3 ) were taken from the website for public consultation and can be found at http://www.nhmrc.gov.au/guidelines/_files/Stage%202%20Consultation%20Levels%20and%20Grades.pdf

Table 2

Definition of NHMRC grades of recommendations.

Grade of recommendation	Description
A	Body of evidence can be trusted to guide practice
B	Body of evidence can be trusted to guide practice in most situations
C	Body of evidence provides some support for recommendation(s) but care should be taken in its application
D	Body of evidence is weak and recommendation must be applied

These grades are based on the following body of evidence matrix:

Table 3

Body of evidence matrix component.

	A Excellent	B Good	C Satisfactory	D Poor
Evidence base	several level I or II studies with low risk of bias	one or two level II studies with low risk of bias or an SR/multiple level III studies with low risk of bias	level III studies with low risk of bias, or level I or II studies with moderate risk of bias	level IV studies, or level I to III studies with high risk of bias
Consistency	all studies consistent	most studies consistent and inconsistency may be explained	some inconsistency reflecting genuine uncertainty around clinical question	evidence is inconsistent
Clinical impact	very large	substantial	moderate	slight or restricted
Generalisability	population/s studied in body of evidence are the same as the target population for the guideline	population/s studied in the body of evidence are similar to the target population for the guideline	population/s studied in body of evidence differ to target population for guideline but it is clinically sensible to apply this evidence to target population	population/s studied in body of evidence differ to target population and hard to judge whether it is sensible to generalise to target population
Applicability	directly applicable to Australian health-care context	applicable to Australian health-care context with few caveats	probably applicable to Australian health-care context with some caveats	not applicable to Australian health-care context