Background
Methods
Trial design
Participant eligibility criteria and identification
Recruitment
General practices
Patients
Randomisation and blinding
Interventions
Usual care
Stratified care intervention
Outcomes measures and analyses
Objective 1
Objective 2
Objective 3
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Low risk: must only have low risk treatment options reported in the EMR
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Medium risk: must have at least one medium risk treatment option and none of the high risk options reported in the EMR
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High risk: patients must have reported within the EMR, at least one high risk treatment option, or a referral to an MSK service providing a medium risk treatment option (e.g. physiotherapy or psychological intervention) with tool subgroup information within their referral so that services were aware that an onward referral to a high risk treatment option might be required.
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> 50% of cases: “Complete success” (proceed to main trial without amendments)
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40–50% of cases: “Partial success” (proceed to main trial with amendments)
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< 40% of cases: “Unsuccessful” (consider whether or not to proceed to main trial)2.Adhere to per protocol matched treatment options in:
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> 65% of cases: “Complete success” (proceed to main trial without amendments)
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50–65% of cases: “Partial success” (proceed to main trial with amendments)
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< 50% of cases: “Unsuccessful” (consider whether or not to proceed to main trial)
Objective 4
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How intense was your pain, on average, over the last 2 weeks? [Responses on a 0–10 scale, where 0 is “no pain” and 10 is “worst pain ever”].
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How much distress have you been experiencing because of your pain, on average, over the last 2 weeks? [Responses from 0 = no distress to 10 = extreme distress]
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How confident have you felt about managing your pain by yourself e.g. medication, changing lifestyle? [Responses from 0 = not at all confident to 10 = extremely confident]4.Anonymised GP medical record audit
Sample size
Results
Objective 1: general practice and participant recruitment and retention rates
Objective 2: to examine evidence of selection bias
Key characteristics | All participants (n = 524) | Intervention participants (n = 231) | Control participants (n = 293) | Non participants (n = 713a) |
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Age, mean (SD) | 61.1 (14.8) | 60.3 (15.1) | 61.8 (14.5) | 53.8 (17.8) |
Female, n (%) | 318 (60.7%) | 133 (57.6%) | 185 (63.1%) | 416 (58.4%) |
Index Multiple Deprivation quintile, n (%) | ||||
1 (least deprived) | 8 (1.5%) | 7 (3.0%) | 1 (0.3%) | 11 (1.6%) |
2 | 55 (10.6%) | 17 (7.4%) | 38 (13.0%) | 102 (14.4%) |
3 | 104 (19.9%) | 55 (23.9%) | 49 (16.7%) | 152 (21.4%) |
4 | 143 (27.3%) | 51 (22.2%) | 92 (21.4%) | 230 (32.4%) |
5 (most deprived) | 213 (40.8%) | 100 (43.5%) | 113 (38.6%) | 216 (30.4%) |
GP Practice, n (%) | ||||
A | 49 (9.4%) | 49 (21.2%) | – | 84 (11.8%) |
B | 11 (2.1%) | – | 11 (3.8%) | 17 (2.4%) |
C | 121 (23.1%) | – | 121 (41.3%) | 197 (27.6%) |
D | 30 (5.7%) | 30 (13.0%) | – | 23 (3.2%) |
E | 59 (11.3%) | 59 (25.5%) | – | 76 (10.7%) |
F | 93 (17.8%) | 93 (40.3%) | – | 99 (13.9%) |
G | 127 (24.2%) | – | 127 (43.3%) | 168 (23.6%) |
H | 34 (6.5%) | – | 34 (11.6%) | 49 (6.9%) |
Pain location, n (%) | ||||
Knee | 144 (27.5%) | 62 (26.8%) | 82 (28.0%) | – |
Neck | 59 (11.3%) | 30 (13.0%) | 29 (9.9%) | – |
Back | 155 (29.6%) | 73 (31.6%) | 82 (28.0%) | – |
Shoulder | 124 (23.7%) | 53 (22.9%) | 71 (24.2%) | – |
Widespread pain | 42 (8.0%) | 13 (5.6%) | 29 (9.9%) | – |
Duration (time since whole month without pain), n (%) | ||||
< 3 months | 136 (26.0%) | 69 (29.9%) | 67 (22.9%) | – |
3–6 months | 77 (14.7%) | 32 (13.9%) | 45 (15.4%) | – |
7–12 months | 89 (17.0%) | 38 (16.5%) | 51 (17.4%) | – |
1–2 years | 75 (14.3%) | 30 (13.0%) | 45 (15.4%) | – |
3–5 years | 53 (10.1%) | 21 (9.1%) | 32 (10.9%) | – |
6–10 years | 48 (9.2%) | 20 (8.7%) | 28 (9.6%) | – |
> 10 years | 46 (8.8%) | 21 (9.1%) | 25 (8.5%) | – |
Health Literacy Single Item Screen (Need help), n (%) [n = 516] | ||||
Never/rarely/sometimes | 500 (96.9%) | 222 (98.3%) | 278 (95.9%) | – |
Often/always | 16 (3.2%) | 4 (1.8%) | 12 (4.2%) | – |
Comorbidities (No. of listed long-term conditions), n (%) | – | |||
0 | 186 (35.5%) | 86 (37.2%) | 100 (34.1%) | – |
1 | 161 (30.7%) | 79 (34.2%) | 82 (28.0%) | – |
2 | 130 (24.8%) | 52 (22.5%) | 78 (26.6%) | – |
≥ 3 | 47 (9.0%) | 14 (6.1%) | 33 (11.3%) | – |
Lives alone (Yes), n (%) [n = 523] | 87 (16.6%) | 40 (17.3%) | 47 (16.1%) | – |
Currently employed (Yes), n (%) [n = 509] | 234 (46.0%) | 104 (46.6%) | 130 (45.5%) | – |
Pain interference with performance at work (0–10, the higher score the worse), mean (SD) | 4.28 (3.06) [n = 257] | 3.87 (2.88) [n = 113] | 4.60 (3.16) [n = 144] | – |
Time-off-work last 6 m due to MSK pain, n (%) [n = 260] | 66 (25.4%) | 28 (24.8%) | 38 (25.9%) | – |
Receipt of written information from GP, n (%) [n = 520] | 213 (41.0%) | 163 (71.5%) | 50 (17.1%) | – |
Pain intensity (at the point of GP consultation) (0–10, the higher score the worse), mean (SD) | 6.33 (2.05) | 6.60 (1.93) | 6.11 (2.11) | 6.35 (2.10)‡ |
Pain intensity (self-reported in baseline questionnaire) (0–10, the higher score the worse), mean (SD) | 6.21 (2.25) [n = 523] | 6.22 (2.17) [n = 230] | 6.21 (2.32) [n = 293] | – |
Self-efficacy (confidence to manage MSK pain) (0–10, the higher score the better), mean (SD) | 5.43 (2.62) [n = 521] | 5.41 (2.67) [n = 228] | 5.44 (2.59) [n = 293] | – |
Distress (0–10, the higher score the worse), mean (SD) | 5.66 (2.61) [n = 524] | 5.62 (2.60) [n = 231] | 5.69 (2.61) [n = 293] | – |
Days of moderate physical activity per week, median (IQR) | 2 (0–4) [n = 521] | 2 (0–4) [n = 230] | 2 (0–4) [n = 291] | – |
No. of previous MSK pain episodes, median (IQR) | 5 (1–25) [n = 415] | 5 (1–15) [n = 186] | 5 (1–30) [n = 229] | – |
MSK Risk status (Keele development version of the STarT MSK Tool – note it was not the final version), mean (SD) [n = 482] | – | |||
Low risk (0–3 score), n (%) | 155 (32.2%) | 67 (30.9%) | 88 (33.2%) | – |
Medium risk (4–7 score), n (%) | 263 (54.6%) | 119 (54.8%) | 144 (54.3%) | – |
High risk (8–9 score), n (%) | 64 (13.3%) | 31 (14.3%) | 33 (12.5%) | – |
Overall musculoskeletal health status (MSK-HQ) (0–56, the higher score the better), mean (SD) | 29.6 (10.4) [n = 507] | 29.9 (10.5) [n = 223] | 29.4 (10.4) [n = 284] | – |
Overall global change (−5–5, the higher score the better), mean (SD) | 0.34 (2.08) [n = 523] | 0.41 (2.19) [n = 230] | 0.28 (1.99) [n = 293] | – |
Fear-avoidance (using 11-item TSK, higher score the worse) mean (SD) | 24.5 (6.80) [n = 511] | 24.3 (6.60) [n = 224] | 24.7 (6.94) [n = 287] | – |
Satisfaction with initial GP care [n = 522] | ||||
Very satisfied, n (%) | 140 (26.8%) | 67 (29.1%) | 73 (25.0%) | – |
Quite satisfied, n (%) | 184 (35.3%) | 81 (35.2%) | 103 (35.3%) | – |
No opinion, n (%) | 115 (22.0%) | 43 (18.7%) | 72 (24.7%) | – |
Not very satisfied, n (%) | 74 (14.2%) | 34 (14.8%) | 40 (13.7%) | – |
Not at all satisfied, n (%) | 9 (1.7%) | 5 (2.2%) | 4 (1.4%) | – |
Patient perceived reassurance from GP for MSK pain (higher score is better) | ||||
Data gathering, mean (SD) | 9.9 (4.3) [n = 502] | 10.5 (4.6) [n = 223] | 9.5 (4.1) [n = 279] | – |
Relationship building, mean (SD) | 11.6 (4.2) [n = 499] | 12.0 (4.4) [n = 220] | 11.3 (3.9) [n = 279] | – |
Generic, mean (SD) | 13.1 (4.7) [n = 507] | 13.2 (5.0) [n = 224] | 13.0 (4.5) [n = 283] | – |
Cognitive, mean (SD) | 13.4 (4.7) [n = 510] | 13.5 (4.9) [n = 223] | 13.2 (4.6) [n = 287] | – |
Total, mean (SD) | 48.0 (16.0) [n = 510] | 49.2 (17.2) [n = 224] | 47.1 (15.0) [n = 286] | – |
Knee physical function using KOOS (the higher score the better), mean (SD) | 42.9 (21.2) [n = 142] | 44.0 (22.1) [n = 61] | 42.0 (20.5) [n = 81] | – |
Neck physical function using NDI (the higher score the worse), mean (SD) | 16.1 (8.02) [n = 59] | 14.6 (6.39) [n = 30] | 17.7 (9.28) [n = 29] | – |
Back physical function using RMDQ (the higher score the worse), mean (SD) | 9.59 (5.50) [n = 155] | 9.84 (5.40) [n = 73] | 9.38 (5.57) [n = 82] | – |
Shoulder function using SPADI-Function (the higher score the worse), mean (SD) | 47.1 (24.8) [n = 124] | 45.9 (25.3) [n = 53] | 48.0 (24.5) [n = 71] | – |
Multi-site physical function using SF12 PCS the higher score the better), mean (SD) | 34.4 (9.52) [n = 42] | 35.5 (9.35) [n = 13] | 33.9 (9.72) [n = 29] | – |
Quality of life using EQ5D-5 L, mean (SD) | 0.56 (0.24) [n = 513] | 0.55 (0.25) [n = 226] | 0.57 (0.22) [n = 287] | – |
Objective 3: assessing GP fidelity to the stratified care intervention
Matched GP treatment options | Low risk (n = 161, 38%) | Med risk (n = 224, 52%) | High risk (n = 45, 10%) | Grand Total | |||
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Advice - verbal | 102 | 63% | 108 | 48% | 23 | 51% | 233 |
Advice - written | 91 | 57% | 140 | 63% | 17 | 38% | 248 |
Advice – over-the-counter medication | 84 | 52% | 10 | 4% | 94 | ||
Advise GP follow-up if symptoms persist | 66 | 41% | 12 | 5% | 78 | ||
Refer to Physiotherapy | 2 | 2% | 85 | 84% | 14 | 14% | 101 |
Refer to MSK interface clinic | 38 | 17% | 10 | 22% | 48 | ||
Refer to pain clinic (multi-disciplinary) | 1 | 0% | 3 | 7% | 4 | ||
Personalised exercise programme | 5 | 2% | 1 | 2% | 6 | ||
Refer to Occupational Health support | 15 | 7% | 3 | 7% | 18 | ||
GP address comorbidity, distress or frailty | 1 | 1% | 7 | 3% | 7 | 16% | 15 |
Prescribe atypical analgesia | 2 | 1% | 59 | 26% | 9 | 20% | 70 |
Prescribe opioids | 1 | 0% | 10 | 22% | 11 | ||
Signpost to peer support group | 2 | 4% | 2 | ||||
Signpost/refer to lifestyle interventions | 2 | 4% | 2 | ||||
Refer for surgical opinion | 3 | 2% | 4 | 2% | 7 | 16% | 14 |
Corticosteroid injection | 1 | 1% | 4 | 9% | 5 | ||
Refer to rheumatology | 2 | 1% | 1 | 2% | 3 | ||
Fidelity to stratified care in decision-making | Pt count | % | |||||
Low risk - per protocol | 130 | 81% | |||||
Medium risk - per protocol | 200 | 89% | |||||
High risk - per protocol | 39 | 87% | |||||
Low risk - given Medium treatments | 3 | 2% | |||||
Low risk - given High treatments | 3 | 2% | |||||
Medium risk – given Low treatments | 0 | 0% | |||||
Medium risk - given High treatment | 5 | 2% | |||||
High risk – given Low treatments only | 3 | 7% | |||||
High risk – given Medium treatments | 0 | 0% | |||||
Low risk – only tool used (no treatments selected) | 25 | 16% | |||||
Med risk – only tool used (no treatments selected) | 19 | 8% | |||||
High risk – only tool used (no treatments selected) | 3 | 7% | |||||
Grand Total | 430 |
Objective 4: describing GP decision-making and patient outcomes in both arms
Key characteristics | Intervention 6 m follow-up (n = 200) | Control 6 m follow-up (n = 258) |
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6-month pain intensity (self-reported), mean (SD) | 3.93 (2.98) [n = 209]a | 4.18 (2.88) [n = 268]a |
Change in pain intensity (0–10, higher score is worse), from GP consultation to 6-month Questionnaire, mean (SD) | −2.6 (3.1) [n = 207] | −1.9 (3.1) [n = 266] |
Pain interference with performance at work (0–10, the higher score the worse), mean (SD) | 3.14 (2.74) [n = 87] | 3.86 (3.13) [n = 115] |
Days of moderate physical activity per week, median (IQR) | 3 (1–4) [n = 199] | 3 (1–4) [n = 257] |
Currently employed (Yes), n (%) | 78 (40.2%) | 101 (39.9%) |
Time-off-work last 6 m due to MSK pain (Yes), n (%) | 15 (17.4%) | 29 (25.4%) |
Overall global change (−5–5, the higher score the better), mean (SD) | 1.20 (2.72) [n = 199] | 1.15 (2.62) [n = 257] |
Risk status using a development version of the Keele STarT MSK Tool, mean (SD) (note: not the final version) | 3.40 (2.70) [n = 190] | 3.64 (2.35) [n = 234] |
Low risk (0–3 score), n (%) | 113 (59.5%) | 127 (54.3%) |
Medium risk (4–7 score), n (%) | 60 (31.6%) | 93 (39.7%) |
High risk (8–9 score), n (%) | 17 (9.0%) | 14 (6.0%) |
Overall musculoskeletal health status (MSK-HQ, 0–56, the higher score the better), mean (SD) | 37.5 (12.8) [n = 193] | 37.3 (11.8) [n = 248] |
Fear-avoidance (using 11-item TSK, higher score the worse) mean (SD) | 22.81 (7.25) [n = 197] | 23.70 (7.24) [n = 253] |
Satisfaction with GP care for MSK pain | ||
Very satisfied, n (%) | 48 (24.2%) | 58 (22.8%) |
Quite satisfied, n (%) | 71 (35.9%) | 89 (34.9%) |
No opinion, n (%) | 46 (23.2%) | 60 (23.5%) |
Not very satisfied, n (%) | 25 (12.6%) | 44 (17.3%) |
Not at all satisfied, n (%) | 8 (4.0%) | 4 (1.6%) |
Knee physical function using KOOS (the higher score the better), mean (SD) | 51.7 (24.5) [n = 55] | 53.6 (22.9) [n = 72] |
Neck physical function using NDI (the higher score the worse), mean (SD) | 7.80 (5.83) [n = 27] | 11.89 (11.57) [n = 24] |
Back physical function using RMDQ (the higher score the worse), mean (SD) | 6.90 (6.52) [n = 61] | 6.44 (5.80) [n = 75] |
Shoulder physical function using SPADI-Function (the higher score the worse), mean (SD) | 30.2 (29.6) [n = 44] | 33.4 (27.8) [n = 62] |
Multi-site physical function using SF12 PCS the higher score the better), mean (SD) | 37.3 (15.1) [n = 12] | 34.7 (10.7) [n = 23] |
Last 6 months saw a professional for MSK pain [n = 421] | 126 (67.0%) | 175 (75.1%) |
Last 6 months received any MSK investigation/treatment [n = 412] | 66 (36.7%) | 66 (28.5%) |
Last 6 months had MSK hospital overnight stay [n = 446] | 5 (2.6%) | 6 (2.4%) |
Quality of life using EQ5D-5 L, mean (SD) | 0.65 (0.26) [n = 208]a | 0.63 (0.25) [n = 258]a |