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National Clinical Guideline Centre (UK). Osteoarthritis: Care and Management in Adults. London: National Institute for Health and Care Excellence (UK); 2014 Feb. (NICE Clinical Guidelines, No. 177.)
Update information: December 2020: in the recommendation on adding opioid analgesics NICE added links to other NICE guidelines and resources that support discussion with patients about opioid prescribing and safe withdrawal management. For the current recommendations, see www.nice.org.uk/guidance/CG177/chapter/recommendations.
N.1. Research question: What are the short-term and long-term benefits of non-pharmacological and pharmacological treatments for osteoarthritis in very old people (for example, aged 80 years and older)?
Why this is important: Very little data exist on the use of pharmacological and non-pharmacological treatments for osteoarthritis in very old people. This is highly relevant, not only because of the ageing population but also because of the high incidence of comorbidities in this population – osteoarthritis may be one of many health problems affecting function, and this may influence the appropriateness of management options. The acceptability, nature and setting for exercise strategies for this population is one area suggested for further study. Any non-pharmacological intervention for which a reduction in the need for drug treatment can be demonstrated is desirable. NSAIDs are frequently contraindicated in older people with comorbidities (such as renal failure, cardiovascular or gastrointestinal intolerance), and effective pharmacological options for this group warrant further study. Outcome and intervention studies are also needed for very old people in whom joint replacement surgery is not recommended because of risks associated with comorbidities.
N.2. Research question: What are the factors influencing, and methods of improving, adherence to osteoarthritis treatments?
Why this is important: Osteoarthritis often results in chronically painful joints for many years. However many treatments, for example muscle strengthening or aerobic exercise, which have significant benefits are often only used by people for a short period of time (weeks). This results in short-duration or limited improvements and the need for further intervention and health care utilisation. It is therefore important to understand both the factors influencing why people ‘opt in’ to specific therapeutic options, and to devise strategies for improving the long-term usage of such treatments. Research in this area may take the form of long term evaluation of strategies to improve adherence, such as the use of e-health or allied health professional contacts for assisting both muscle strengthening exercises and weight loss. It is imperative such studies have intrinsic health economic evaluations given the size of the osteoarthritis burden for the NHS.
N.3. Research question: What are the benefits of combinations of treatments for osteoarthritis, and how can these be included in clinically useful, cost-effective algorithms for long-term care?
Why this is important: Most people with osteoarthritis have symptoms for many years, and over this time they will receive several treatments, sometimes in combination. This may involve a combination of non-pharmacological and pharmacological treatments, such as using a walking stick and taking analgesics at the same time. Perhaps more commonly, a person may take different analgesics at the same time (for example, NSAIDs and opioids). However, most of the osteoarthritis trial evidence only evaluates single treatments, and often such trials are of short duration (for example, 6 weeks). We need to understand the benefits of combination treatments relevant to particular anatomical sites of osteoarthritis (for example, hand compared with knee) and whether particular combinations provide synergistic benefit in terms of symptom relief. Also needed is an understanding of how combinations of treatments can be included in algorithms (for example, dose escalation or substitution designs) for use in clinical practice. Trials to address this area may need to utilise complex intervention methodologies with health economic evaluations, and will need to stratify for comorbidities that affect the use of a particular intervention.
N.4. Research question: What are effective treatments for people with osteoarthritis who have common but poorly researched problems, such as pain in more than one joint or foot osteoarthritis?
Why this is important: Although people with osteoarthritis typically have symptoms that affect one joint at any particular time, there are still many people, especially older people, who have more than one painful joint. For example, it is common for osteoarthritis to affect both knees, or for a person to have pain in one knee and in one or more small joints such as the base of the thumb or the big toe. The mechanisms that cause pain may differ in people with one affected joint compared with those who have pain in several joints. For example, altered use because of pain in one joint often leads to increased mechanical stress and pain at other sites, and having chronic pain at one site can influence the experience of pain elsewhere in the body. However, almost all trials of treatments for osteoarthritis focus on a single joint, and if a participant has bilateral symptoms or additional symptoms at a different joint site only one ‘index’ joint (the most painful) is assessed. Whether systemic treatments for osteoarthritis work less well if a person has more than one painful site, and whether local treatment of one joint (for example, injection of corticosteroid into a knee) can lead to benefits at other sites (for example, the foot) remains unknown. A further caveat to current research evidence is that most trials focus on treatment of knee osteoarthritis, and to a lesser extent hip or hand osteoarthritis, but there are very few trials that examine other prevalent sites of osteoarthritis such as the first metatarsophalangeal (bunion) joint, the mid-foot joints, the ankle or the shoulder. Trials should be undertaken to determine the efficacy of available treatments, both local and systemic, at such sites. New outcome instruments to measure pain, stiffness and function specific to osteoarthritis at each site may need to be developed and validated for use in such trials.
N.5. Research question: Is it possible to identify predictors of response to individual treatments in people with osteoarthritis?
Why this is important: Osteoarthritis is complex in terms of pain (with both peripheral and central components) and range of structural pathology (of which we are increasingly aware because of information from modern imaging studies using modalities such as magnetic resonance imaging and ultrasound). It may be that certain treatments have increased efficacy if targeted to subsets of the osteoarthritis population, selected for specific characteristics. At present, there are few useful sub-classifications of osteoarthritis to guide interventions. There is evidence from randomised controlled trials showing that some individuals do respond to specific analgesics or anti-inflammatories even when there is no benefit at the group or mean level. Even those studies which show overall mean benefit for a NSAID have often selected subjects by a flare design, where only those who lose effect coming off a NSAID enter the study, thereby enriching the study sample with potential responders. Where agents have no clear clinical efficacy at the group level (e.g. paracetamol), or have benefit that is statistically but not clinically significant beyond the non-specific treatment effect (e.g. acupuncture & hyaluronans), identification of subgroups which may benefit from these agents could be justified. The design of these studies should be informed by previous studies, including systematic reviews and meta-analyses, to guide the baseline variables to be collected that may predict response (e.g. presence/absence of inflammation on musculoskeletal ultrasound).
N.6. Research question: Which biomechanical interventions (such as footwear, insoles, braces and splints) are most beneficial in the management of osteoarthritis, and in which subgroups of people with osteoarthritis do they have the greatest benefit?
Why this is important: In many people, osteoarthritis is made worse by weight-bearing or biomechanical forces through an affected joint. For example, base of thumb pain may be worse with grabbing and lifting items. Local support for the joint, in this case via a thumb splint, may improve pain and function. A large range of devices are available to help people with osteoarthritis in different joints, but there are very few trials to demonstrate their efficacy, and in particular little data to guide healthcare professionals on which people would benefit most from these aids. For example, there are many knee braces available, but few well designed randomised controlled trials of their efficacy, and few suggestions for clinicians on which patient sub-groups might benefit from their use. Trials in the device area require careful attention to design issues such as the selection of control or sham interventions, blinded assessments and the choice of validated outcome measures that reflect the specific joint or functional ability being targeted.
N.7. Research question: What outcome measures are the most effective indicators to identify patient benefits of effective self-management strategies and support for self-management of osteoarthritis?
Why this is important: Self-management can promote patient knowledge, and the skills and confidence to manage osteoarthritis through consultations, training and support from health care professionals. However the outcomes measured as indicators of success vary widely and self-management strategies for osteoarthritis have repeatedly shown negligible to small effects in outcomes such as disability and pain. Furthermore, self-management interventions for osteoarthritis can be undertaken as part of chronic disease care. Added to this are new technologies and e-health approaches to self-management. Outcomes and indicators of successful self-management and self-management support have included: resource utilisation, hospitalisation rates, self-efficacy, quality of life, knowledge, clinical severity, functional status, self-management behaviours, barriers to self-management and health status. They have been used alone or in combination according to the different programmes. It is therefore difficult to directly compare the effect of different self-management interventions because of the wide variation in outcomes. ‘Time’, as osteoarthritis is a chronic long term condition, is not often taken into account and outcomes may not accurately reflect programme components. Quality indicators and outcome measures of osteoarthritis self-management need to be developed and tested for the evaluation of long term outcome. Indicators and outcomes need to match the content of the intervention. A core set of measures for osteoarthritis self-management should be proposed via systematic review, indicator mapping, qualitative study and consensus of the osteoarthritis community (including patients and carers). Such measures should be adopted in subsequent guideline updates.
N.8. Research question: For individuals with osteoarthritis, is a patient centred approach to information giving and pain management more effective and cost effective in improving important outcomes compared to group self-management programmes?
Why this is important: Self-management strategies for osteoarthritis have repeatedly shown negligible to small effects in outcomes such as disability and pain. A patient centred approach to supporting self- management can be offered across a range of multidisciplinary consultations for osteoarthritis, and over a period of time, whereas group sessions may be offered for episodes of care by dedicated members of the multidisciplinary team. Osteoarthritis is a long term chronic condition and requires consistency of care over time where patients consult a wide variety of health professionals for their osteoarthritis and their other comorbidities. A randomised controlled trial with nested qualitative study could investigate whether, for individuals with osteoarthritis, a patient centred approach to information giving and pain management is more effective and cost effective in improving important outcomes compared to group self-management programmes. Important outcomes may include pain, changes in prescriptions for symptom control, positive health seeking behaviours and participation in activities of daily living, quality of life.
N.9. Research question: In people with osteoarthritis, are there treatments that can modify joint structure, resulting in delayed structural progression and improved outcomes?
Why this is important: There is evidence from observational studies that factors affecting structural joint components, biomechanics and inflammation in and around the joint influence the progression of osteoarthritis. Symptoms appear to be more closely linked to structure than was once thought, so preventing progression of the structural deterioration of a joint is expected to deliver symptomatic benefits for people with osteoarthritis, as well as delaying joint replacement in some. There have been published randomised controlled trials with interventions targeting structural components of cartilage (glucosamine sulphate) and bone (strontium ranelate). However, several limitations have been identified with the glucosamine sulphate studies, and it is unclear whether cardiovascular concerns will prevent approval of strontium ranelate for treating osteoarthritis. Randomised, placebo-controlled trials of adequate power and duration (related to the structural end point under consideration) should be undertaken to determine the benefits and side effects of agents with disease-modifying osteoarthritis drug potential for treating both hip and knee osteoarthritis (separately). Appropriate structural end points may include progression of radiographic joint space narrowing or MRI features of osteoarthritis. Associated clinical end points could include measures of pain, function and health-related quality of life. Studies should also include rates of subsequent joint replacement (preferably maintaining original blinding, even if extensions are open label). Later phase trials should include a health economic evaluation.
N.10. Research question: What is the optimum timing and content of review and follow-up for people with osteoarthritis and how this may relate to structured pathways of care?
Why this is important: Patient follow up is essential for reinforcement of core treatment, for supporting people to self-manage their condition and to review treatment efficacy. Opportunistic review can be patient led or health care professional led however there is a lack of efficacy of different models. Continuation of core treatment e.g. exercise and weight loss, should form a key component of review. A randomised controlled trial to determine the clinical and cost effective ness of review and follow up for people with osteoarthritis is needed. The population for review may include any of the following people with osteoarthritis with: troublesome joint pain, multisite involvement, multiple comorbidities, on medication for symptom relief and those undertaking complex behaviour change interventions. The timing of review or follow up would include a clear rationale e.g. annual review as part of chronic disease management pathway; and a clear definition e.g. patient led, health care professional led. A comparator would be selected to represent usual single episodes of care. Outcomes would include impact of the disease on symptoms, function and quality of life, and uptake of self-management.
N.11. Research question: What is the minimal important difference for the main clinical outcomes in OA?
Why this is important: When looking at the results of clinical trials, it is not sufficient for a treatment to be statistically superior to another; it must provide a clinically meaningful benefit. The minimal important difference (MID) has therefore been suggested to assist clinical decision-making. This may differ for different outcomes (e.g. pain or function). One international study suggested that a change of15 out of a 100 for an absolute reduction or 20% relative reduction should be the bench mark for the minimum clinical important difference. However, applying the MID concept is difficult. The MID may vary between populations, and with how it is calculated (for example, based on the anchor question that related a particular outcome to a patient meaningful result). Care needs to be taken when considering the metrics of the instruments upon which MID calculations are made. As well, clinical decision making has never been made based on efficacy alone. It is a trade-off process between risk and benefit, therefore a cut-off for the risk-benefit ratio may be need to be considered. Studies in this area may involve simulation studies to understand bias, secondary analysis of existing datasets and new studies using different anchor questions.
N.11.1. Criteria for selecting high-priority research recommendations
| PICO question | What are the benefits of combinations of treatments for osteoarthritis, and how can these be included in clinically useful, cost-effective algorithms for long-term care? |
|---|---|
| Importance to patients or the population | Osteoarthritis is extremely common in UK ageing population. Most people with OA use combinations of therapies |
| Relevance to NICE guidance | Would inform future recommendations |
| Relevance to the NHS | Because of the paucity of effective OA therapies, front line health care professionals need to know of useful combinations and synergies of combinations |
| National priorities | None |
| Current evidence base | Extremely limited trial data on combining either pharmacological and non-pharmacological or combining different pharmacological treatments |
| Equality | The research question has no equality issues |
| Study design | Randomised controlled trials and pragmatic randomised trials are feasible |
| Feasibility | The population to be studied is large and the interventions often not costly |
| Other comments | None |
| Importance | High: essential for future recommendations |
| PICO question | What are effective treatments for people with osteoarthritis who have common but poorly researched problems, such as pain in more than one joint or foot osteoarthritis? |
|---|---|
| Importance to patients or the population | The majority of trials of osteoarthritis therapies have focussed on knees, and to lesser extent hips with a few hand OA trials. Multi-site joint pain including OA is common in a large proportion of the population. Osteoarthritis of the foot may be as common as knee osteoarthritis. |
| Relevance to NICE guidance | Will make future guidance relevant to a much larger proportion of the community |
| Relevance to the NHS | These are hugely common problems for primary and secondary care health care professionals |
| National priorities | None |
| Current evidence base | Virtually no trial data for multiple site joint pain including OA or for foot OA |
| Equality | The research question has no equality issues |
| Study design | Some focus on development of relevant outcome measures is required before intervention studies can be conducted |
| Feasibility | The population to be studied is large and the interventions often not costly |
| Other comments | None |
| Importance | High: essential for future recommendations |
| PICO question | Which biomechanical interventions (such as footwear, insoles, braces and splints) are most beneficial in the management of osteoarthritis, and in which subgroups of people with osteoarthritis do they have the greatest benefit? |
|---|---|
| Importance to patients or the population | Given the paucity of effective osteoarthritis therapies and the biomechanically driven nature of the OA processes, these interventions are important to almost all people with osteoarthritis |
| Relevance to NICE guidance | Would improve range of therapeutic options |
| Relevance to the NHS | Huge unmet need for rationale, cost-effective use of biomechanical devices |
| National priorities | None |
| Current evidence base | Few well designed trials |
| Equality | The research question has no equality issues |
| Study design | Randomised trials using sham interventions with attention to blinded assessment |
| Feasibility | The population to be studied is large and the interventions often not costly |
| Other comments | None |
| Importance | High: essential for future recommendations |
| PICO question | In people with osteoarthritis, are there treatments that can modify joint structure, resulting in delayed structural progression and improved outcomes? |
|---|---|
| Importance to patients or the population | There are currently no licensed structure modifying osteoarthritis therapies. The hope remains that maintaining or improving structural pathology will prevent subsequent progression of symptoms |
| Relevance to NICE guidance | There is no acceptance of structure modification therapies at present |
| Relevance to the NHS | Need to prevent huge burden of progressive osteoarthritis |
| National priorities | None |
| Current evidence base | There are many trials examining structure modification but concerns about the performance and measurement characteristics of the imaging tools applied and the powering of studies |
| Equality | The research question has no equality issues |
| Study design | Randomised controlled trials with attention to powering on the basis of particular imaging modality and tissue pathology under study. ‘Time to joint replacement’ as an outcome requires careful evaluation |
| Feasibility | While the study population is large, imaging modalities need to be standardised in multi-centre studies; structure modifying studies are often expensive due to participant numbers and duration of follow up |
| Other comments | None |
| Importance | High: proof of the structure modification principle is required |
- Research question: What are the short-term and long-term benefits of non-pharmacological and pharmacological treatments for osteoarthritis in very old people (for example, aged 80 years and older)?
- Research question: What are the factors influencing, and methods of improving, adherence to osteoarthritis treatments?
- Research question: What are the benefits of combinations of treatments for osteoarthritis, and how can these be included in clinically useful, cost-effective algorithms for long-term care?
- Research question: What are effective treatments for people with osteoarthritis who have common but poorly researched problems, such as pain in more than one joint or foot osteoarthritis?
- Research question: Is it possible to identify predictors of response to individual treatments in people with osteoarthritis?
- Research question: Which biomechanical interventions (such as footwear, insoles, braces and splints) are most beneficial in the management of osteoarthritis, and in which subgroups of people with osteoarthritis do they have the greatest benefit?
- Research question: What outcome measures are the most effective indicators to identify patient benefits of effective self-management strategies and support for self-management of osteoarthritis?
- Research question: For individuals with osteoarthritis, is a patient centred approach to information giving and pain management more effective and cost effective in improving important outcomes compared to group self-management programmes?
- Research question: In people with osteoarthritis, are there treatments that can modify joint structure, resulting in delayed structural progression and improved outcomes?
- Research question: What is the optimum timing and content of review and follow-up for people with osteoarthritis and how this may relate to structured pathways of care?
- Research question: What is the minimal important difference for the main clinical outcomes in OA?
- Research recommendations - OsteoarthritisResearch recommendations - Osteoarthritis
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