1.1.4.1. Included studies

Fifty-six randomised-controlled trial studies (eighty-four papers) were included in the review;^{4, 7, 8, 18, 24, 33, 36–38, 43, 45, 46, 56, 75, 80, 87, 89, 93–95, 98, 99, 103, 106, 109, 125–127, 130, 132, 138, 141, 144, 146, 148, 150, 151, 155, 156, 159, 167, 184, 186, 208, 211, 222, 228, 230, 235, 236, 244, 253, 261, 266–268, 279, 288} these are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 3). The majority of studies included people with knee or hip osteoarthritis (with a minority including people with hand osteoarthritis). Three studies^{45, 138, 186} reported including people with chronic knee pain, without specifying that they had osteoarthritis. These studies were included but noted to be an indirect population.

The treatment packages included in this review used the following interventions as components:

• Exercise^{7, 8, 18, 24, 33, 36–38, 43, 45, 46, 56, 80, 89, 94, 98, 99, 103, 106, 125, 126, 130, 132, 138, 141, 144, 146, 148, 150, 155, 156, 159, 167, 184, 186, 208, 211, 235, 236, 244, 266, 267, 279, 288}
• Manual therapy²²⁸
• Electrotherapy^{109, 268}
• Devices⁴
• Combinations of the above with additional interventions (including acupuncture and pharmacological management)^{75, 87, 93, 95, 127, 151, 222, 230, 253, 261}

These were combined with:

• Behaviour change interventions (including joint protection, pain coping skills training, goal setting, weight management counselling, ect.)^{7, 18, 36–38, 43, 45, 46, 56, 94, 95, 98, 103, 106, 126, 127, 130, 132, 138, 141, 144, 146, 148, 150, 167, 184, 186, 208, 222, 235, 236, 279}
• Educational programmes^{4, 8, 24, 33, 75, 80, 87, 89, 93, 99, 109, 125, 151, 155, 156, 159, 211, 228, 230, 244, 253, 261, 266–268, 288}

The treatment packages varied in length, including studies delivered over less than or equal to 6 weeks and more than 6 weeks.

No relevant clinical studies comparing treatment packages to the following non-combined active treatments were identified:

• Acupuncture
• Pharmacological management (oral, topical, transdermal or intra-articular therapy)
• Arthroscopic procedures

See also the study selection flow chart in Appendix C, study evidence tables in Appendix D, forest plots in Appendix E and GRADE tables in Appendix F.

1.1.4.2. Excluded studies

Two Cochrane reviews were identified and checked ^{136, 292} but were not included in the review. This was because the reviews did not include treatment packages by the definition used in our protocol.

See the excluded studies list in Appendix J.

1.1.5.1. Treatment packages compared to exercise alone

Table 2

Summary of studies included in the evidence review for the comparison of treatment packages and exercise alone.

1.1.5.2. Treatment packages compared to manual therapy alone

Table 3

Summary of studies included in the evidence review for the comparison of treatment packages and manual therapy alone.

1.1.5.3. Treatment packages compared to electrotherapy alone

Table 4

Summary of studies included in the evidence review for the comparison of treatment packages and electrotherapy alone.

1.1.5.4. Treatment packages compared to behaviour change interventions alone

Table 5

Summary of studies included in the evidence review for the comparison of treatment packages and behaviour change interventions alone.

1.1.5.5. Treatment packages compared to education programmes alone

Table 6

Summary of studies included in the evidence review for the comparison of treatment packages and education programmes alone.

1.1.5.6. Treatment packages compared to standard care (non-organised) or no treatment

Table 7

Summary of studies included in the evidence review for the comparison of treatment packages and standard care (non-organised) or no treatment.

See Appendix D for full evidence tables.

1.1.6.1. Treatment packages compared to exercise alone

Table 8

Clinical evidence summary: treatment packages compared to exercise alone.

1.1.6.2. Treatment packages compared to manual therapy alone

Table 9

Clinical evidence summary: treatment packages compared to manual therapy alone.

1.1.6.3. Treatment packages compared to electrotherapy alone

Table 10

Clinical evidence summary: treatment packages compared to electrotherapy alone.

1.1.6.4. Treatment packages compared to behaviour change interventions alone

Table 11

Clinical evidence summary: treatment packages compared to behaviour change interventions alone.

1.1.6.5. Treatment packages compared to education programmes alone

Table 12

Clinical evidence summary: treatment packages compared to education programmes alone.

1.1.6.6. Treatment packages compared to standard care (non-organised) or no treatment

Table 13

Clinical evidence summary: treatment packages compared to standard care (non-organised) or no treatment.

See Appendix F for full GRADE tables.

1.1.7.1. Included studies

Four health economic studies with relevant comparisons were included in this review: one comparing treatment packages to exercise alone ³⁷; and three comparing treatment packages to usual care.^{118, 144, 179} These are summarised in the health economic evidence profiles below (Table 14 and Table 15) and the health economic evidence tables in Appendix H.

1.1.7.2. Excluded studies

No relevant health economic studies were excluded due to limited applicability or methodological limitations.

See also the health economic study selection flow chart in Appendix G.

1.1.11.1. The outcomes that matter most

The critical outcomes were health-related quality of life, pain and physical function. These were considered critical due to their relevance to people with osteoarthritis. The Osteoarthritis Research Society International (OARSI) consider that pain and physical function were the most important outcomes for evaluating interventions. Health-related quality of life gives a broader perspective on the person’s wellbeing, allowing for examination of the biopsychosocial impact of interventions. The important outcomes were psychological distress, osteoarthritis flare and discontinuation. Discontinuation events were included for this review as a measure of the tolerability of the treatment package compared to the individual components and standard care.

The committee considered osteoarthritis flares to be important in the lived experience and management of osteoarthritis. However, these were also considered difficult to measure with no clear consensus on their definition. The Flares in OA OMERACT working group have proposed an initial definition and domains of OA flares through a consensus exercise; “it is a transient state, different from the usual state of the condition, with a duration of a few days, characterized by onset, worsening of pain, swelling, stiffness, impact on sleep, activity, functioning, and psychological aspects that can resolve spontaneously or lead to a need to adjust therapy.“ However, this has been considered to have limitations and has not been widely adopted. Therefore, the committee included the outcome accepting any reasonable definition provided by any studies discussing the event.

Mortality was not considered in the outcomes. Osteoarthritis as a disease process is not considered to cause mortality by itself and so any mortality was considered to either be due to the intervention or external factors. Given this, the committee did not feel that mortality required a specific outcome. Additionally, as this intervention included a combination of interventions that were included in other review questions, the committee agreed that there was unlikely to be additional risks of mortality from combining the interventions and so this did not need to be investigated separately. Finally, while mortality is not examined separately, participants may be included in the discontinuation outcome due to mortality. The committee were informed where this was the case to inform their decision making.

There was no evidence available for osteoarthritis flares. The committee acknowledged this as an important outcome rather than a critical one and agreed that they could make recommendations even though there was limited information for this outcome. While there was evidence available for other outcomes, there was only limited evidence available for psychological distress throughout the literature.

1.1.11.2. The quality of the evidence

Fifty-five randomised-controlled trial studies were included in this review. Evidence was available comparing treatment packages to exercise alone, manual therapy alone, electrotherapy alone, behaviour change interventions alone, educational programmes alone and standard care (non-organised) or no treatment. There was no evidence comparing treatment packages to acupuncture alone, devices alone, pharmacological management alone and arthroscopic procedures alone. The evidence for treatment packages in some far included combinations with all of the previously listed interventions apart from arthroscopic procedures.

The quality of the evidence varied across comparisons and outcomes but was in general between moderate and very low quality. Outcomes were most often downgraded for risk of bias and imprecision. Where downgraded for risk of bias this was often for selection bias and/or performance bias (as it was not possible to blind participants and those delivering the intervention to the allocated treatment in most cases). On occasions outcomes were downgraded for inconsistency when there was heterogeneity in the results. Some studies included indirect populations. However, these studies were often in a minority out of the study included in an outcome, so this only rarely influenced the quality rating.

1.1.11.3. Benefits and harms

1.1.11.4. Cost effectiveness and resource use

Four economic evaluations were included in the review. All were in people with knee osteoarthritis.

The first study took a UK perspective and was based on a single-blind pragmatic randomised controlled trial. It had a follow-up of 1 year. The treatment package was two supervised exercise sessions a week over 5 weeks while the comparator was outpatient physiotherapy with a maximum of 10 sessions. The study itself was small with only 67 patients recruited at baseline. QALYs were reported using the EQ-5D measure. An important difference between the two arms related to costs. The intervention was delivered in a group setting while the comparator was not. Since costs were reported on a per patient basis, the intervention was calculated to be cheaper than the comparator. Cost per QALY results were presented, however there were no sensitivity analyses nor analysis of uncertainty. The study was graded as partially applicable with potentially serious limitations.

The second study took an Australian perspective with a time horizon of 1 year. Pain coping skills training alone and in combination with exercise were compared to exercise alone. QALYs were captured using the AQoL-6D. The incremental QALYs were reported to one significant figure only and the addition of another significant figure resulted in vast variations in the final cost per QALY. The study did not report final cost per QALYs, so these were calculated from the available data. This study was graded as being partially applicable with potentially serious limitations.

The other two studies took a Canadian perspective. One study compared structured education and neuromuscular exercise to usual care (defined as educational pamphlets about knee osteoarthritis with the option of pain medication) while the other compared treatment management by various healthcare professionals to usual care (defined as an educational pamphlet on knee osteoarthritis by The Arthritis Society). The first study calculated QALYs using the EQ-5D measure while the other study collected this data using both the HUI3 and the PAD-5D. Both studies were graded as partially applicable. The time horizon in the first study was 1 year. The costs for the intervention were estimates based primarily on expert consultation and group-based programmes while costs for the comparator arm were taken from a study published in 2004. The second study had a time horizon of 6 months. While it defined resource use associated with the treatments, it was unclear how unit costs were assigned to each component of resource use. It was also unclear how the second study valued preference weights for utilities and how QALYs were calculated. For these reasons, both studies were deemed to have potentially serious limitations.

The first study reported that treatment packages dominated outpatient physiotherapy, being cheaper and more effective. The other three studies reported that treatment packages were cost effective at a threshold of £20,000 per QALY gained.

1.1.11.5. Other factors the committee took into account

The committee noted that the research identified does not appear to represent the diverse population of people with osteoarthritis. While they did not make a research recommendation for this review, they agreed that any further research should be representative of the population, including people from different family backgrounds, and socioeconomic backgrounds, disabled people, and people of different ages and genders. Future work should be done to consider the different experiences of people from diverse communities to ensure that the approach taken can be made equitable for everyone.

1.1.12. Recommendations supported by this evidence review

This evidence review supports recommendation 1.3.4. Other evidence supporting these recommendations can be found in evidence review K.

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