3.1. Patients’ preferences and expectations
1061 Potentially eligible participants were identified from referral forms, of whom 709 (66.8%) were ineligible or did not want to participate. summarises the flow of patients and follow-up in this study.
Flow chart summarising follow-up on clinical outcomes and treatment preferences and expectations.
Of the 709 who did not participate in the trial, 94 responded to the additional questions about treatment preferences and expectations; 71% reported a treatment preference of whom 40% stated exercise and 16% stated acupuncture. Other examples included hydrotherapy and heat. Using the numerical rating scale (where 0 is expectation of no benefit and 10 is expectation of being completely better), those not participating in the trial had a mean level of expectation for advice and exercise of 6.2 (2.7) and for acupuncture, 3.6 (3.4).
Of the 352 participants randomised to the trial, only 70 (20%) reported a treatment preference. shows baseline characteristics (socio-demographic, knee specific and randomised treatment) for those with and without a treatment preference; two participants did not complete this question. Patients reporting a preference were similar to those reporting no preference, although patients who had knee symptoms for less than 1 year were more likely to have no treatment preference. Patients with and without treatment preferences were randomised equally to all treatment arms of the trial.
Baseline characteristics of trial participants: comparing those with and without a treatment preference.
At baseline, all participants were asked which treatment they would choose if they had a free choice: 10% stated advice and exercise, 13% acupuncture and 44% both. Very few other treatments were reported, with similar responses across the randomised groups (Table S1
). Treatment preferences and overall strength of preferences for each treatment were similar between groups. Patients’ outcome and treatment expectations are summarised in Table S1
. Patients had, on average, high expectations of improvement at baseline. Overall mean baseline levels of expectation of benefit from treatments were 5.9 (2.3) and 6.3 (2.2) for advice and exercise, and for acupuncture, respectively, and there was little difference between the three trial arms. Very few patients reported expecting the available treatments to be of ‘little’ or ‘no’ help.
presents the unadjusted and adjusted coefficients testing the relationships between patients’ baseline treatment preferences and expectations and their clinical outcome (WOMAC pain subscale) at 6 and 12 months. There was no relationship between patients’ baseline treatment preferences and the change in their knee pain over time.
Association of patients baseline treatment preferences and expectations with change in WOMAC pain score.
In total, 163 participants were matched for their treatment preference, i.e. they stated a preference for the treatment they were randomised to. The degree of matching was similar for the two acupuncture groups (A&E plus true acupuncture n = 70 and A&E plus non-penetrating acupuncture n = 78) but was much lower for advice and exercise alone (n = 15). Patients who received the treatment for which they had stated a preference did not obtain greater reductions in pain (see ).
Association of patients baseline treatment preferences and expectations with OMERACT-OARSI responder.
In total, 202 participants were matched for their treatment expectation, ie they gave a high score (6–10) for the treatment they were randomised to. The degree of matching was similar for those randomised to advice and exercise (n = 65), A&E plus true acupuncture (n = 70), and A&E plus non-penetrating acupuncture (n = 67). There was no relationship between general outcome expectations at baseline and pain reduction at 6 and 12 months.
Patients who received the treatment for which they had expressed high expectations did not have lower pain scores over time. When treatment response was considered using a secondary outcome, the OMERACT-OARSI responder criteria, those patients who received the treatment for which they had high expectations of benefit were more likely to be classified as a treatment responder at 6 months (adjusted odds ratio (OR) 1.72 (1.06, 2.79)) and 12 months (adjusted OR 1.88 (1.13, 3.13)).
3.2. Physiotherapists’ expectations and preferences
Physiotherapists expressed a treatment preference for 43% of patients. Overall, the physiotherapists had high expectations of improvement for their patients, reporting a mean general outcome expectation of 6.6 (2.0) out of 10. They had similar expectations of benefit from advice and exercise (6.0 (1.8)) and acupuncture (5.8 (1.9)), with little difference between the three trial arms (Table S2
3.3. Matched patient and physiotherapist treatment expectations and preferences
presents the predictive ability of matched treatment expectations and preferences (the match of both patient and therapist) for outcome at 6 and 12 months as measured by the WOMAC pain scale. In total, 51 patients were matched for both their own and their physiotherapist’s treatment preference, ie both the patient and their physiotherapist gave a preference for the treatment they were randomised to. The degree of matching was similar for the two acupuncture groups (A&E plus true acupuncture n = 21 and A&E plus non-penetrating acupuncture n = 24) but was lower for advice and exercise alone (n = 6). There was no relationship between matching the patients’ and physiotherapists’ preference with the treatment received and patients’ clinical outcome.
Association of baseline treatment expectations and preferences with change in WOMAC pain score and OMERACT-OARSI responder at follow-up: matched for both participant and physiotherapist.
120 Patients were matched for both their own and their physiotherapist’s treatment expectation, ie both the patient and their physiotherapist gave a high expectation score for the treatment they were randomised to. The degree of matching was similar for those randomised to advice and exercise (A&E) (n = 41), A&E plus true acupuncture (n = 40), and A&E plus non-penetrating acupuncture (n = 39). There was no clear evidence that when patients received the treatment for which both they, and their therapist, held high expectations, that the change in pain was greater than when there was no match.