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. 2020 Jul 6;15(7):e0235364. doi: 10.1371/journal.pone.0235364

Table 2. Summary of findings.

Evidence treatment options across regional musculoskeletal pain presentations
Treatment Options Service Model Evidence base Outcomes / Effects Comments Overall Strength of evidence (Grade)
Clinical outcome (pain and disability) Open access 1 Trial (Holdsworth 2007, Overman et al 1988), 2 Cohorts (Badke et al 2014, Denninger 2018); 2 Service evaluations (Ojha 2015, Mallet 2014). Small differences between groups (e.g., Mean functional improvement score at discharge 15.2 ±11.7 for self-referred patients vs 14.6 ±10.6 for GP led care; p = 0.77) on a 0–100 scale for function) and (e.g., percent decrease in pain 64.6% for self-referrers vs 66.6% for Physician referred patients; p = 0.76), Badke et al. 2014; Mean improvement in function from baseline, 54%; 95% CI: 46%, 62%) and pain (mean difference, 4 points; 95% CI: 1, 7 points), with no differences between groups (P>.05), Denninger 2018). Overall, patients displayed good clinical improvement in disability and pain, with no differences between groups (P >.05). Between group differences in pain and function were also not sustained in the long term (>12 months). ** Limited evidence
Combination 2 cross-sectional analysis of patient cohort. Ludvigsson 2012; Phillips 2012 Mean (SD) summary index (EQ VAS) of self-rated health including pain and functional disability on a scale from 0 to 100: 67 (18) for self-referred patients vs. 56 (19) for GP-led care; p = 0.006). Ludvigsson 2012. Mean pain intensity (VAS (SD)) 6.91 (9.4), p<0.001 at 3 months follow up. Significant differences were found between groups. Relatively small data-set (n = 93) from a patient cohort. Philips et al 2012 was compared to baseline but did not include comparison group data.
Service based pathway 1 cluster randomised trial. Bishop et al 2017 Perceived change from baseline:4% of self-referred patients vs. 6.5% of GP-led care patients reported complete recovery at 6 months Evidence from pilot trial. (cluster randomisation based on GP practices).
Clinical outcome (Quality of life) Open access 2 Cohort (Denninger 2018; Goodwin 2016/Moffatt 2017). Beneficial effects demonstrated. Small, statistically insignificant differences between groups at follow-up (e.g. percent change in pre-post EQ 5D mean (SD) at 6 months 0.13 (0.27) Goodwin 2016). Comparable improvements (slightly better among self-refers) in QoL outcomes for up to 2 years across studies. **Limited evidence
Combination 2 cross-sectional analysis of patient cohort. Ludvigsson 2012; Phillips 2012 e.g., mean EQ 5D (SD) 0.65 (0.22) for self-referred groups vs. 0.51 (0.30) for GP led care at 3 months, p = 0.014 Ludvigsson et al; and 0.82 (0.2) at 3months, p<0.001 Phillips et al 2012. Unadjusted analysis
Service based pathway 1 cluster randomised trial. Bishop et al 2017 Mean EQ 5D score (SD) for control practices vs intervention practices respectively: @ baseline: 0.565 (0.246) vs. 0.544 (0.262) @ 6 months 0.602 (0.251) vs. 0.594 (0.262) @ 12 months 0.615 (0.254) vs. 0.606 (0.258) Quality of life increased similarly in both arms compared to baseline across all follow-up time points
Safety outcomes (adverse effects and missed red-flag diagnoses) Open access 2 Cohort (Denninger 2018, Goodwin 2016) 2 service evaluation (Mintken 2015, Moore 2005). Other studies without safety as a priori outcomes: (McGill et al 2013, Ojha 2015, Pendergast et al 2012, Holdsworth 2007, Greenfield 1975, Boissonnault 2010, 2016, Desjardins-Charbonneau et al 2016) No adverse events/effects, missed red flag diagnoses due to accessing care through MSK triage and direct access/self-referral across all included studies. MSK triage/direct access presented no higher risks to patients. However, most services included specially trained and/or more senior professionals. *** Moderate evidence
Combination Other studies without safety as a priori outcomes: Ferguson et al 1999 Informal liaison with GPs, access to patient medical notes, and use of pre-defined protocol/checklists for minimising mis-diagnosis.
Service based pathway 1 cluster randomised trial. Bishop et al 2017 No evidence that the direct access pathway led to adverse events, missed diagnosis of serious pathologies. No comparison with control practices without direct access services.
Socio-economic outcomes (work absence and sickness certification) Open access 1 Trial (Holdsworth 2007) 1 cross-sectional analysis (McGill et al 2013) (Mean MSK related work absence, S.D., range (days): 2.5, ±10.6, 0 to 120 for self-referrers; vs. 6.0, ±19.6, 0 to 300; p = 0.048). Holdsworth et al 2007 94% drop in lost time from work due to MSK related condition over 12 months. Consistently large differences in favour of direct across/self-referral for up to 12 months across studies. *** Moderate evidence
Combination 1 cross sectional analysis (Bornhoft 2015) 1 analysis of patient cohort (Phillips 2012). N (%) of sick-leave recommendations for direct access and GP led care respectively. 82 (14.1%) vs. 369 (23.2%) @ 6months 73 (15.1%) vs. 338 (23.5%) @ 12 months. Bornhft 2015. Mean (SD) Sickness absence @ baseline and @ 3months 4.6 (12.6) vs. 1.45 (9.7); p <0.05 Mean (SD) Work performance @ baseline and @ 3months 75.9 (19.6) vs. 87.8 (13.2); p <0.001. Phillips et al 2012 Significant differences in work related outcomes relative to baseline.
Service based pathway 1 cluster randomised trial. Bishop et al 2017 Mean (SD) work related costs associated with MSK conditions: £740.30 (2084.75) for control practices vs £ 539.36 (2069.43) for intervention practices who accessed care via MSK triage/ direct self-referrals. Work related absence costs were significantly higher for patients without direct access. Outcome over 12 month period.
Health care utilisation (costs, further consultations, prescriptions, tests, referrals, and impact on GP workload/services) Open access 2 Trial (Holdsworth 2007, Greenfield 1975), 3 Cohorts (Badke et al 2014, Denninger 2018, Goodwin 2016); 2 Service evaluations (Ojha 2015, Swinkels 2014). 4 cross-sectional analysis (McGill et al 2013, Mitchell et al 1997, Pendergast et al 2012) Badke- Mean total cost of care per patient (SD): $2423.5 (2555.3). Mean total cost of care per patient (SD): $3878.7 (2923.8) Denninger 2014. Total cost care per patient (SD): 1542 (108, 2976). For DA vs 3085 (1939, 4224) McGill et al 2013: Medication use: Medication use: 24.07% for DA compared to 90.53% for GP led care. Radiology use: 11.11% compared to 82.11% for GP led care. Overall, consistently significant differences in health care utilisation costs (higher for usual GP-led care compared to MSK triage and direct access/self-referral) ***Moderate evidence
Combination 1 cross sectional analysis (Bornhoft 2015) 2 analysis of patient cohort (Phillips 2012; Ludvigsson 2012. 1 service evaluation (Mallet 2014)
Service based pathway 1 cluster randomised trial. Bishop et al 2017

*Very weak evidence: Perspective / opinions only/ Absence of empirical data (from qualitative or quantitative studies).

** Limited evidence: Some empirical evidence from cohort and cross-sectional observational studies, lacking comparisons with usual GP led care, AND when there were small, inconsistent, or non-significant differences in patient related outcomes, OR without.

*** Moderate evidence: Some empirical evidence from trials, good quality cohort and cross-sectional analyses of large data sets including, comparisons with usual GP led care, and /or with small to moderate but consistent effects on patient related outcomes.

**** Strong evidence: Evidence from good quality trials, cohort and cross-sectional analyses of large data sets including direct access, comparisons with usual GP led care, and /or with moderate to strong consistent effects on patient related outcomes.