Randomised controlled trial: results

C Salisbury; NE Foster; C Hopper; A Bishop; S Hollinghurst; J Coast; S Kaur; J Pearson; A Franchini; J Hall; S Grove; M Calnan; J Busby; AA Montgomery

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Salisbury C, Foster NE, Hopper C, et al. A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of ‘PhysioDirect’ telephone assessment and advice services for physiotherapy. Southampton (UK): NIHR Journals Library; 2013 Jan. (Health Technology Assessment, No. 17.2.)

Chapter 3Randomised controlled trial: results

Generalisability

Patients were recruited between July 2009 and December 2009, and followed up until June 2010.

We considered several patient characteristics in order to evaluate the generalisability of this study: sex, age, deprivation (as measured in quintiles based on postcode), PCT and body region of MSK problem.

We compared the characteristics of patients in two groups: (a) those who were ineligible for the study on the basis of their referral letter (Table 4) or because they did not confirm that they wanted physiotherapy and (b) those who were eligible.

Among the eligible patients, we also compared those who did or did not consent to participate and were randomised to participate in the trial.

Obvious differences between those patients who were or were not eligible, reflecting the eligibility criteria, were observed for the site of MSK problem for which patients were referred to physiotherapy. A higher proportion of patients in Bristol and a lower proportion in Somerset were deemed eligible. More women were referred than men, and slightly fewer men were eligible. Patients who were eligible were slightly older than those whose who were ineligible (Table 5).

Considering the eligible patients, those patients who were randomised were slightly younger, on average, than those who were not. Apart from this, there were few differences between those who were randomised and those who were not (Table 5).

Patients from the least deprived areas (quintile 1) were under-represented in this study in comparison with the national population. Patients who were from the most deprived areas were slightly less likely to be eligible or to consent to participate in the study and be randomised.

The recruitment rate, defined as the percentage of patients consenting to participate from those who were eligible (responding to the invitation letter confirming that they did want physiotherapy), was 2256/4523 or 50% (Figure 2).

Baseline comparability of randomised groups

No marked difference was observed between patients randomised to the two arms of the trial in terms of demographic, stratification/minimisation or outcome variables at baseline (Table 6). At baseline, 59% of participants in the trial were female, 96% were white, the majority were in employment, and patients from the least deprived areas were under-represented. Almost everyone had access to a telephone and the vast majority had access to a car (Table 7).

The most common reasons for referral were lower limb problems (including hip and knee problems), lumbar problems and upper limb problems (including shoulder). Participants from each of the PCTs were reasonably well represented, with Bristol contributing the highest proportion. People were fairly evenly split in their preference for future care between usual care, PhysioDirect and having no preference (see Table 7). There were no important differences in outcome measures assessed at baseline (Table 8).

Loss to follow-up

Primary outcome data were collected for 88% (1985/2249) of patients at the 6 weeks' follow-up time point and 85% (1912/2249) of patients at the primary outcome time point of 6 months, with no difference between trial arms. Details of the relationship between loss to follow-up and patient characteristics are given in Appendix 1.

Several differences were observed between patients for whom the primary outcome measure (SF36v2 PCS at 6 months) was collected and those for whom it was missing, although these differences were similar for both trial arms (see Appendix 1, Tables 62 and 63). With regards to the demographic characteristics, patients with missing data tended to be younger, unemployed and to come from more deprived areas. There was also an association between job type and missing primary outcome data (see Appendix 1, Table 62).

As described in Chapter 1 (see Summary of changes to the project protocol), we obtained ethical permission for a protocol amendment to continue inviting patients to participate until 2000 patients had been recruited, in order to ensure that we reached our target of 1500 patients for analysis. Because of the lag time between initial approach to patients and recruitment, and because the final follow-up rate was higher than assumed, the total number of patients available for analysis (1912) was higher than originally planned (1500).

Process of care

In the context of this trial it is most helpful to describe the types of care received by participants in each arm of the trial, before describing the primary and secondary outcomes. This will aid interpretation of these outcomes.

Number of telephone and face-to-face consultations

Patients in the PhysioDirect arm were offered an initial telephone call to assess their need and priority for a face-to-face appointment. Of all patients in the PhysioDirect arm, 1281 (85%) contacted the service at least once, with 97% (1239/1281) of these having an initial telephone call and 3% (42) having an initial face-to-face appointment. Of those having an initial telephone assessment, 47% (586/1239) were managed entirely on the telephone with the remainder having at least one face-to-face consultation. Of all patients in the PhysioDirect arm, only 46% (695/1506) eventually had any face-to-face appointments (Table 9).

By the time of the first follow-up time point at 6 weeks after randomisation, 81% of patients in the PhysioDirect arm had received some sort of assessment appointment or consultation, compared with only 50% of those in the usual-care arm.

There is strong evidence that PhysioDirect greatly increases the odds of having at least one appointment or consultation (of any type) by 6 weeks [adjusted odds ratio (OR) 4.49 (95% CI 3.68 to 5.49); p < 0.001].

The following table shows the number of consultations that patients received in each arm of the trial. Over the 6-month follow-up period, patients in the PhysioDirect arm had significantly fewer face-to-face consultations, and fewer consultations in total (including telephone and face-to-face consultations), compared with those in the usual-care arm (Table 10).

Table 11 below details the distribution of the number of face-to-face consultations experienced by patients in each arm. This is further divided into all of those patients, or only those patients who had any face-to-face consultations. For those who did have any face-to-face consultations, a ‘course of treatment’ was a mean number of face-to-face consultations of 3.77 (95% CI 3.57 to 3.96) and 4.13 (95% CI 3.94 to 4.33) in the usual care and PhysioDirect arms, respectively. The number of appointments was skewed with a median number of face-to-face consultations of 3 [interquartile range (IQR) 2 to 5] and 4 (IQR 2 to 6) in the usual care and PhysioDirect arms, respectively.

Length of consultations

The mean and median lengths of the face-to-face consultations in minutes were 34.1 (SD 11.3) and 30 (IQR 30 to 40), respectively. Telephone consultations had a mean and median length of 23.9 (SD 12.2) and 23 (IQR 17 to 30) minutes, respectively.

The mean length of telephone calls in the PhysioDirect service was monitored throughout the trial and it was observed that the mean duration of calls decreased during the study. This is illustrated by Figure 3. The figure shows the mean duration of telephone calls, from the first week of calls in each site. However, as the study progressed an increasing proportion of calls were follow-up calls, which tended to be shorter.

Figure 4 shows the same analysis restricted to first calls only, and confirms that call duration became shorter over the period of the trial.

Did not attend rates

The rate of failed face-to-face appointments (DNA rate) at 6 months was measured in two different ways: (1) as an overall rate, namely the ratio of the number of unattended appointments over that of all appointments that had been scheduled; and (2) as an individual patient rate, with the DNA rate calculated for each patient as an incidence rate ratio (IRR) adjusted for age, sex and primary outcome at baseline and PCT.

The overall rate was substantially the same in the two trial arms, being 262/2310 (11%) for usual care and 279/2873 (10%) for PhysioDirect. The individual DNA rates had median 0 for both arms, with means of 0.12 for usual care and 0.09 for PhysioDirect. The effect estimated for PhysioDirect on the DNA rate (adjusting for age, sex, primary outcome at baseline and PCT) was 0.55 (95% CI 0.41 to 0.73) with p < 0.001. Therefore, there was strong evidence of PhysioDirect being associated with an average 45% reduction in individual patient DNA rate.

Waiting times

Waiting time to the first consultation, be it a telephone or face-to-face consultation, was calculated for each patient from both the referral date and the randomisation date (Table 12). The possible effect of PhysioDirect on each of those waiting times was estimated through Accelerated Failure Time analysis, adjusting for PCS at baseline, age, sex, main referral problem and PCT. Both in the referral and the randomisation case there was strong evidence (p < 0.001) of PhysioDirect substantially decreasing the waiting time, a reduction of up to 68%. This equates to a shorter wait of 7 days from randomisation. The median delay introduced by the need to obtain consent in the trial was 12 days (this is the difference between the date the referral was received and the date written patient consent was received).

One aim of PhysioDirect is to filter out people who will not benefit from face-to-face care, so that those who do need it can be seen more quickly. There was no evidence that the waiting time to first face-to-face appointment was different between the PhysioDirect and the usual-care arms (Table 13).

Characteristics of patients seen in face-to-face appointments in the PhysioDirect arm

In an exploratory analysis, we compared the characteristics of patients in the PhysioDirect arm who were then seen in face-to-face appointments following initial telephone assessment with those who were managed entirely on the telephone (Table 14). There were no differences in terms of age or sex. However, there were slight differences according to site of MSK problem, and patients managed entirely on the telephone had slightly higher SF-36v2 PCS scores at baseline than those seen face to face [37.6 and 35.4, respectively, difference in means 2.36 (95% CI 1.38 to 3.33)].

Primary outcome analysis

No evidence was found of a difference in the PCS of the SF-36v2 between the two trial arms at either the 6-week follow-up time point or the primary time point of 6 months, having adjusted for baseline outcome measure, sex, age, main referral problem and the patient's PCT (Table 15). The 95% confidence limits support the hypothesis of equivalence in terms of clinical outcome between the trial arms. Figure 5 illustrates the difference in means and confidence limits in relation to the observed variation in the primary outcome (SD) and the pre-specified equivalence limits of 2 points on the SF-36v2 PCS.

A repeated measure analysis was conducted to estimate possible variations in treatment effect on SF-36v2 PCS at different points in time, namely at 6 weeks and 6 months. The analysis showed no evidence of such variations, with an arm–time interaction for SF-36v2 PCS adjusted for outcome baseline, sex, age, referral problem and PCT of 0.001 (95% CI −0.0041 to 0.006; p = 0.76).

Secondary analyses

Sensitivity analyses

Adjustment for baseline imbalances

Some imbalance at baseline was observed for the employment status variable, but including it as a covariate in the ANCOVA did not change the conclusion of the original primary analysis, namely no evidence of any difference between PhysioDirect and usual care on SF-36v2 PCS at 6 months (Table 16).

Effect of missing primary outcome data

Although only about 15% of the primary outcome data were missing in each trial arm, multiple imputations were conducted to determine what effect those data might have had on the primary analysis. The conclusion that there was no evidence of difference between the trial arms was the same with or without multiple imputations of missing data (Table 17).

Clustering effects

The possibility of clustering effects due to patients belonging to the same PCT or GP practice was explored through multilevel models with random effects attributed to those clusters. Each one of the models was compared with the original one (fixed effects) for its goodness of fit relative to the data by means of a log–likelihood ratio test or through its Akaike information criterion (AIC, lower value corresponding to a better fit), which accounts both for likelihood and parsimony of the model.

The only model for which there was some evidence of a better fit to the data than the one adopted for the primary analysis was a model accounting for a PCT clustering effect, but it maintained the conclusions of the original model (i.e. equivalence between PhysioDirect and usual care) and the clustering effect appeared to be very modest as indicated by an intracluster correlation (ICC) of 0.005 (Table 18).

Secondary outcomes

Clinical outcomes

A similar regression analysis as the primary one (same covariate adjustments) was conducted using a set of secondary outcomes, representing different ways of assessing health status. These were:

a patient-generated measure, focusing on specific symptoms (MYMOP)
a broad measure of health-related quality of life (EQ-5D) to be used in the economic analysis
a single question about the extent to which the main problem for which the person had been referred to physiotherapy had improved (global improvement score)
a measure of whether or not the individual had ‘responded to treatment’ using the OMERACT-OARSI criteria, based on a composite measure including physical function, pain and improvement in the main problem.

The results of the analysis of MYMOP showed a statistically significant difference between the trial arms at 6 weeks but this difference was very small and the CIs fell within the limits of equivalence that we specified for the MYMOP measure a priori (0.5 points). Both the global improvement score and the analysis according to the OMERACT-OARSI criteria also suggested that patients in the PhysioDirect arm were more likely to have improved to a greater extent by 6 weeks than those in the usual-care arm. The EQ-5D showed a slight trend towards benefit from PhysioDirect at 6 weeks but the difference was small and may well have been due to chance.

It is notable that all five measures of clinical outcome (the four secondary outcomes in Table 19 and the primary outcome SF-36v2 PCS) showed a similar pattern of slightly better scores from PhysioDirect at 6 weeks, with minimal difference after 6 months' follow-up.

It should be pointed out that there is some dependence between measures in that two of the elements in the OMERACT-OARSI ‘response to treatment’ measure were based on improvements in scores on the ‘physical function’ and ‘pain’ scales from the SF-36 questionnaire, and the questions that make up these scales also contribute to the SF-36 PCS score, which is the primary outcome.

The following table (Table 20) shows the scores for each of the individual scales from the SF-36v2 measure, at both 6 weeks and 6 months. There is no evidence of difference between the trial arms on any measure, at either time point. This table also demonstrates that all of the measures improved over time in both arms of the trial.

Time lost from work

No evidence was found of a difference between the two trial arms in time lost from work due either to the medical condition or to physiotherapy-related treatment provided through the trial (Table 21). This analysis included only patients who were in work.

Preference for future care

Patients' preference for the type of care they would prefer (usual care, PhysioDirect or having no preference) was recorded both at baseline and at 6 months from randomisation. Although none of the categories was particularly favoured at baseline in either arm, after 6 months usual care was the preferred choice for those patients allocated to the usual-care arm, whereas patients allocated to the PhysioDirect arm appeared almost split in their preference between usual care and PhysioDirect. An analysis of the possible effect on preference by the PhysioDirect intervention by means of multinomial logistic regression provided evidence that it substantially increases the odds of preferring PhysioDirect to indifference (Table 22). So, although, normally, patients at 6 months would prefer usual care, PhysioDirect can reduce that tendency in its own favour. This is illustrated by Figure 6.

Patient satisfaction

Some evidence was found of slightly higher satisfaction for patients in usual care than for those in PhysioDirect with regards to both satisfaction with the quality of the consultation and overall satisfaction. No difference is evident with regards to satisfaction with access to the service (Table 23).

It is important to note that data presented in Table 23 are based on a comparison only of patients who had had any advice from a physiotherapist, either face to face or on the telephone. People who were still on the waiting list at 6 weeks following randomisation (predominantly in the usual-care group) did not complete the questionnaire, and satisfaction with access to care may be different among this group.

We explored whether or not there was an interaction between baseline patient preference and randomisation group in terms of satisfaction with the service, in other words, whether or not people's satisfaction with the service they received was related to their initial preference. We found no such interaction for any of the three components of satisfaction. We also explored whether or not there was an interaction between patient preference and randomisation group with respect to effectiveness (based on the primary outcome of SF-36v2 PCS). Again we found no such interaction.

Analysis of free-text comments from questionnaires to obtain the views of patients regarding waiting time from referral

We noted above that the people who may have been least satisfied with access were those who had not received any physiotherapy but they would not have completed the satisfaction questions. We observed that many people added free-text comments to the questionnaire. Therefore, in a post hoc analysis we undertook a quantitative analysis of these free-text comments.

In the final section of the 6-week and 6-month follow-up questionnaires, participants were invited to comment on ‘Things that were good about the service’ and ‘Things that could be improved’. These comments were entered in full as part of routine data entry. Content analysis was performed to assess:

Whether or not (from the comment) the patient had received physiotherapy (by telephone or face to face) at that point.
The patient's view of waiting time from referral, coded as positive, negative, both, or not stated. An example of when ‘both’ applied would be when the patient was appreciative of the prompt telephone contact but unhappy with the wait to be seen face to face.

The comments from all 6-week and 6-month questionnaires were coded by one researcher. Validation of the coding was carried out by a second researcher, independently coding a 1 in 10 sample. Where there were discrepancies, the coding was discussed and a final coding agreed. The resulting agreement for whether or not patients had had physiotherapy was 98% at 6 weeks and 97% at 6 months; the agreement for view of waiting time was 98% at 6 weeks and 95% at 6 months.

Results are shown comparing patients in the usual care and PhysioDirect arms of the trial (Tables 24 and 25).

It is clear from the results presented above that the free-text comments provide a different perspective, compared with the ‘access’ questions in the questionnaire, on respondents' views on waiting time for advice and treatment for physiotherapy. More positive comments were made in the PhysioDirect arm and more negative comments were made in the usual-care arm.

Adverse events

Despite requesting reports of AEs from physiotherapists and from GPs, and after reviewing the GP notes of all patients in the trial, no AEs were detected in either arm of the trial. In particular, no AEs were detected from 4323 consultations (1445 by telephone and 2878 face to face) over 6 months in 2249 patients allocated to PhysioDirect.

Subgroup analysis

Possible differences in the effect of PhysioDirect compared with usual care on the SF-36v2 PCS at 6 months between subgroups based on age, main referral problem, deprivation or PCT, were analysed by estimating the interaction term of those factors with assigned treatment. No evidence was found of subgroup differences for the primary outcome (Tables 26 and 27). However, potentially important differences cannot be excluded as the CIs are very wide, reflecting the limited power available for subgroup analyses.

Finally, we report descriptive data about the pattern of responses on the primary outcome for patients with different sites of MSK problem (Table 28). This demonstrates that different types of problem have different impacts on health status; most improve substantially over time (by up to 8 points, when the SD of the PCS in this population is 8.8 points at baseline); and that most of this improvement had occurred by 6 weeks following randomisation. Patients with thoracic or ‘other MSK’ problems improved the least over the 6 months' follow-up, whereas those with lumbar, limb or widespread pain problems improved the most. We have already demonstrated (see Table 15) that there is no evidence of difference overall between the trial arms in terms of improvement, or any evidence that some conditions benefited to a greater extent than others through a PhysioDirect service (see Table 26).

Figures

FIGURE 2

Consolidated Standards of Reporting Trials (CONSORT) diagram: flow of participants through the trial, a. Per cent is expressed as n/1506 × 100. b, Per cent is expressed as n/743 × 100.

FIGURE 3

Mean duration of first telephone calls over time: all calls.

FIGURE 4

Mean duration of first telephone calls over time: first calls only.

FIGURE 5

Difference in means in relation to equivalence limits.

FIGURE 6

Preference for PhysioDirect or usual care. (a) Baseline. (b) At 6 months.

Tables

TABLE 4

Reasons why referrals were ineligible for invitation

Reason	No. (%)
< 18 years	180 (13)
Hearing problems	27 (2)
Non-English language	27 (2)
Non-MSK problem	166 (12)
Needs domiciliary physiotherapy	197 (14)
Very urgent	376 (26)
Postoperative	105 (7)
In trial already	178 (13)
Problem unsuitable for telephone consult	135 (9)
Problem unsuitable for physiotherapy	12 (1)
Patient unsuitable for telephone consult	41 (3)
Other (reason stated)	9 (1)
Other (reason not stated)	89 (6)

: n = 1424 (21% of all referrals). Note: Some referrals had multiple reasons.

TABLE 5

Comparisons between those who were or were not eligible and were or were not randomised

Patient characteristics	Wanted physiotherapy and eligible: n = 6870 (100%)			Randomisation: n = 4523 (65.84%)
Patient characteristics	No: n = 2347 (34.16%)	Yes:^a n = 4523 (65.84%)	Test	Not randomised: n = 2267 (50.12%)	Randomised:^a n = 2256 (49.88%)	Test
Sex (%)
Female	56.97	59.74	x₁² = 4.90, p = 0.03	59.91	59.44	x₁² = 0.10, p = 0.75
Male	43.03	40.26		40.09	40.56
Median age (years) (IQR)	46.0 (31.0 to 62.0)	50.1 (37.3 to 63.0)	Rank-sum, z = −6.79, p < 0.001	52.00 (38.0 to 65.0)	48.30 (36.5 to 61.3)	Rank-sum, z = 5.64, p < 0.001
Deprivation quintile (5 = most deprived) (%)
1	8.76	10.24	x₄² = 14.43, p = 0.01	10.31	10.32	x₄² = 7.16, p = 0.13
2	19.72	20.06		20.13	20.04
3	25.51	27.00		25.84	28.37
4	22.04	22.53		22.17	22.58
5	23.96	20.18		21.55	18.70
PCT (%)
Bristol	26.5	31.70	x₃² = 42.16, p < 0.001	30.14	21.55	x₃² = 5.29, p = 0.15
Somerset	29.19	23.17		23.79	33.29
Cheshire	21.39	23.86		24.39	23.36
Stoke	22.92	21.27		21.68	20.57
Site of problem for which referred (%)
Cervica	8.73	12.74	x₈² = 582.08, p < 0.001	13.06	12.15	x₇² = 3.78, p = 0.80
Thoracic	1.67	2.17		2.14	2.17
Lumbar	25.49	27.8		28.25	27.41
Upper limb	19.03	23.38		23.37	23.37
Lower limb	26.56	29.09		28.34	29.93
Widespread pain	0.68	0.58		0.47	0.67
Multiple MSK	4.32	3.76		3.90	3.64
Other MSK	6.46	0.49		0.47	0.67
Non MSK	7.06	0.00		NA	NA

: IQR, interquartile range; NA, not applicable.
a: Including seven post-randomisation exclusions.

TABLE 6

Baseline demographic characteristics of the patients randomised

Patient baseline characteristics	Randomised patients: n = 2249^a (100%)
Patient baseline characteristics	Usual care: n = 743 (33.04%)	PhysioDirect: n = 1506 (66.96%)
Sex^b (%)
Female	58.95	59.56
Male	41.05	40.44
Median age^b (years) (IQR)	48.18 (36.01 to 61.93)	48.27 (36.72 to 61.01)
Ethnicity (%)
White	95.79	96.71
Black	1.09	0.87
Asian	1.63	1.01
Dual/mixed	0.95	0.74
Chinese	0.14	0.13
Other	0.41	0.54
Deprivation quintile (5 = most deprived) (%)
1	9.92	10.57
2	20.95	19.61
3	29.33	27.96
4	21.79	22.88
5	18.02	18.98
Employment status (%)
Employed	57.05	62.08
Unemployed	6.16	4.70
Student	2.60	2.55
Ill/disabled	7.11	5.57
Retired	22.02	20.40
Not working/other	5.06	4.70
Profession (%)
Administrative	16.91	13.54
Technical	10.73	11.72
Elementary	8.78	10.21
Manager	10.57	9.34
Personal services	7.32	9.34
Operatives	5.53	5.62
Professional	17.56	17.97
Customer services	11.22	11.24
Skilled trade	11.38	11.01

: IQR, interquartile range.
a: Excluding seven post-randomisation exclusions.
b: Stratification/minimisation variable.

TABLE 7

Baseline characteristics related to the physiotherapy problem or physiotherapy service

Patient baseline characteristics	Randomised patients: n = 2249^a (100%)
Patient baseline characteristics	Usual care: n = 743 (33.04%)	PhysioDirect: n = 1506 (66.96%)
Site of MSK problem^b (%)
Cervical	11.99	12.28
Thoracic	1.75	2.32
Lumbar	27.36	27.36
Upper limb	23.45	23.31
Lower limb	30.32	29.88
Widespread pain	0.94	0.53
Multiple MSK	3.64	3.65
Other MSK	0.54	0.66
PCT^b (%)
Bristol	33.78	33.13
Somerset	22.21	23.11
Cheshire	23.42	23.44
Stoke	20.59	20.32
Physiotherapy preference (%)
Usual care	32.97	30.71
PhysioDirect	35.29	35.57
No preference	31.74	33.72
Median time off work (days) (IQR)	0 (0-5)	0 (0-5)
English, native speaker (%)
No	2.88	3.64
Yes	97.12	96.36
Telephone (%)
No	0.54	0.93
Yes	99.46	99.07
Car (%)
No	17.12	16.72
Yes	82.88	83.28

: IQR, interquartile range.
a: Excluding seven post-randomisation exclusions.
b: Stratification/minimisation variable.

TABLE 8

Outcome variables at baseline for the patients randomised to the two arms of the trial

Patient outcome measures at baseline	Randomised patients: n = 2249^a (100%)
Patient outcome measures at baseline	Usual care: n = 743 (33.04%)	PhysioDirect: n = 1506 (66.96%)
SF-36v2 PCS
Mean (SD)	37.72 (8.63)	36.81 (8.88)
Median (IQR)	37.59 (31.39 to 43.93)	36.95 (30.44 to 43.16)
SF-36v2 MCS
Mean (SD)	45.66 (13.29)	46.07 (12.65)
Median (IQR)	47.86 (36.24 to 56.55)	48.46 (36.51 to 56.52)
MYMOP
Mean (SD)	3.80 (0.99)	3.84 (0.99)
Median (IQR)	3.75 (3.25 to 4.50)	4.00 (3.25 to 4.50)
EQ-5D
Mean (SD)	0.56 (0.29)	0.53 (0.30)
Median (IQR)	0.69 (0.43 to 0.76)	0.69 (0.23 to 0.76)

: IQR, interquartile range; MCS, Mental Component Score.
a: Excluding seven post-randomisation exclusions.

TABLE 9

Types of consultations experienced by patients

Type of appointment and time point	No. of patients (%) with different types of consultation/appointment
Type of appointment and time point	Usual care: n = 743	PhysioDirect: n = 1506
No appointments of any type
6 weeks	371 (50)	292 (19)
6 months	125 (17)	225 (15)
Only face-to-face appointments^a
6 weeks	341 (46)	20 (1)
6 months	540 (73)	35 (2)
Only telephone consultations
6 weeks	7 (1)	767 (51)
6 months	4 (0.5)	586 (39)
Telephone and face to face
6 weeks	23 (3)	427 (28)
6 months	73 (10)	660 (44)
Home visit only
6 weeks	1 (0.13)	0 (0)
6 months	1 (0.1)	0 (0)
Odds of having at least one appointment or consultation, irrespective of type, OR (95% CI)^b
6 weeks	4.49 (3.68 to 5.49), p < 0.001
6 months	1.13 (0.89 to 1.45), p = 0.32

a: ‘Face to face’ includes appointments that were booked, whether or not they were attended.
b: Adjusting for sex, age, main referral problem, PCT.

TABLE 10

Number of consultations

Consultations	Period	Usual care: n = 743	PhysioDirect: n = 1506	IRR^a	95% CI	p-value
Face-to-face, no. arranged:^b mean (SD); median (IQR)	6 weeks	0.89 (1.13); 0 (0 to 2)	0.58 (1.08); 0 (0 to 1)	0.64	0.56 to 0.73	< 0.001
Face-to-face, no. arranged:^b mean (SD); median (IQR)	6 months	3.11 (2.63); 3 (1 to 4)	1.91 (2.72); 0 (0 to 3)	0.59	0.53 to 0.65	< 0.001
Telephone: mean (SD); median (IQR)	6 weeks	0.04 (0.22); 0 (0 to 0)	0.87 (0.55); 1 (1 to 1)	19.79	13.85 to 28.28	< 0.001
Telephone: mean (SD); median (IQR)	6 months	0.13 (0.44); 0 (0 to 0)	0.96 (0.63); 1 (1 to 1)	7.34	5.87 to 9.17	< 0.001
Home visits: mean (SD); median (IQR)	6 weeks	0.001 (0.04); 0 (0 to 0)	0.002 (0.04); 0 (0 to 0)	1.48	0.15 to 14.25	0.73
Home visits: mean (SD); median (IQR)	6 months	0.004 (0.06); 0 (0 to 0)	0.003 (0.06); 0 (0 to 0)	0.82	0.20 to 3.45	0.79
Total consultations: mean (SD); median (IQR)	6 weeks	0.94 (1.17); 1 (0 to 2)	1.46 (1.29); 1 (1 to 2)	1.53	1.37 to 1.70	< 0.001
Total consultations: mean (SD); median (IQR)	6 months	3.25 (2.70); 3 (1 to 5)	2.87 (2.94); 1 (1 to 5)	0.87	0.80 to 0.94	0.001

: IQR, interquartile range; IRR, incidence rate ratio.
a: Adjusted for time, outcome baseline, sex, age, referral problem, PCT.
b: Appointments booked, whether or not attended.

TABLE 11

Number of face-to-face consultations

No. of appointments	No. of patients
	Face-to-face appointments				Face-to-face appointments in those who had any face-to-face appointments
	PhysioDirect		Usual care		PhysioDirect		Usual care
	n	% of patients	n	% of patients	n	% of patients	n	% of patients
0	811	(53.9)	130	(17.5)
1	97	(6.4)	99	(13.3)	97	(14)	99	(16.2)
2	108	(7.2)	110	(14.8)	108	(15.5)	110	(17.9)
3	136	(9)	123	(16.6)	136	(9.6)	123	(20.1)
4	98	(6.5)	96	(12.9)	98	(14.1)	96	(15.7)
5	78	(5.2)	70	(9.4)	78	(11.2)	70	(11.4)
6	70	(4.7)	45	(6.1)	70	(10.1)	45	(7.3)
7	40	(2.7)	24	(3.2)	40	(5.8)	24	(3.9)
8	23	(1.5)	17	(2.3)	23	(3.3)	17	(2.8)
9	13	(0.9)	10	(1.4)	13	(1.9)	10	(1.6)
10	11	(0.7)	4	(0.5)	11	(1.6)	4	(0.7)
11	8	(0.5)	8	(1.1)	8	(1.2)	8	(1.3)
12	5	(0.3)	1	(0.1)	5	(0.7)	1	(0.2)
13	4	(0.3)	3	(0.4)	4	(0.6)	3	(0.5)
14	2	(0.1)	2	(0.3)	2	(0.3)	2	(0.3)
15	1	(0.1)	0	(0)	1	(0.1)	0	(0)
16	1	(0.1)	0	(0)	1	(0.1)	0	(0)
17	0	(0)	1	(0.1)	0	(0)	1	(0.2)
Total	1506	(100)	743	(100)	695	(100)	613	(100)

TABLE 12

Number of days to first consultation (telephone or face to face)

Date from	Waiting time (days): median (IQR)		Accelerated failure time analysis^a
Date from	Usual care: n = 618	PhysioDirect: n = 1281	Arm–time ratio	95% CI	p-value
Referral	48 (32 to 66)	19 (13 to 32)	0.43	0.41 to 0.46	0.001
Randomisation	34 (20 to 55)	7 (4 to 15)	0.32	0.29 to 0.35	0.001

a: Adjusting for baseline PCS, age, sex, main referral problem and PCT.

TABLE 13

Number of days to first face-to-face consultation from the randomisation date

Date from	Waiting time (days): median (IQR)		Accelerated failure time analysis^a
Date from	Usual care: n = 613	PhysioDirect: n = 695	Arm–time ratio	95% CI	p-value
Randomisation	35 (20 to 55)	30 (17 to 55)	0.95	0.88 to 1.03	0.25

a: Adjusting for baseline PCS, age, sex, main referral problem and PCT.

TABLE 14

Within PhysioDirect arm, characteristics of patients invited for face-to-face consultation

Patient baseline characteristics	Whether or not seen in face-to-face consultation: n = 1281^a (100%)
Patient baseline characteristics	Telephone only: n = 586 (45.7%)	Telephone and face to face: n = 695 (54.3%)
Referral problem, n (%)
Cervical	64 (10.9)	91 (13.1)
Thoracic	11 (1.9)	15 (2.2)
Lumbar	165 (28.2)	179 (25.8)
Upper limb	131 (22.5)	176 (25.3)
Lower limb	195 (33.3)	195 (28.0)
Widespread pain	1 (0.2)	6 (0.9)
Multiple MSK	16 (2.7)	31 (4.5)
Other MSK	3 (0.5)	2 (0.3)

a: All of those in PhysioDirect arm, excluding those who had no consultations of any type.

TABLE 15

Primary outcome: SF-36v2 PCS at 6 weeks and 6 months following randomisation

Time point	SF-36v2 PCS
	Usual care		PhysioDirect		Difference in means^a	95% CI	p-value
	Mean (SD)	n	Mean (SD)	n	Difference in means^a	95% CI	p-value
Baseline	37.72 (8.63)	743	36.81 (8.88)	1504	NA	NA	NA
6 weeks	41.81 (10.30)	653	41.57 (10.26)	1332	0.42	−0.28 to 1.12	0.24
6 months	44.18 (10.84)	629	43.50 (10.94)	1283	−0.01	−0.80 to 0.79	0.99

: NA, not applicable.
a: Adjusted for: outcome baseline, gender, age, referral problem, PCT.

TABLE 16

Comparison of the estimates of trial arms difference in SF-36v2 PCS at 6 months with and without adjustment for employment status at baseline

Additional adjustment	Arm difference: SF-36v2 PCS at 6 months^a	95% CI	p-value
None	−0.01	−0.80 to 0.79	0.99
Employment status	−0.24	−1.01 to 0.54	0.55

a: Adjusted for outcome baseline, sex, age, referral problem, PCT

TABLE 17

Comparison of estimates of the difference in primary outcome between trial arms with and without multiple imputation of the missing values

Multiple imputations	Arm difference: SF-36v2 PCS at 6 months^a	95% CI	p-value
0	−0.01	−0.80 to 0.79	0.99
20	−0.03	−0.76 to 0.82	0.94

a: Adjusted for outcome baseline, sex, age, referral problem, PCT.

TABLE 18

Estimates of arm difference in primary outcome for models which do or do not account for possible clustering effects

Model	Arm difference: SF-36v2 PCS at 6 months^a	95% CI	p-value	ICC	Likelihood ratio test vs linear (p-value)	AIC
FE	−0.01	−0.80 to 0.79	0.99	0	1	13,528.62
FE + RE intercept for: PCT	−0.003	−0.80 to 0.79	0.99	0.005	0.01	13,533.55
FE + RE intercept and slope for: PCT	−0.01	−0.80 to 0.78	0.98	Intercept: PCT < 0.001 Slope: baseline PCS < 0.001 Age < 0.001	0.11	13,534.29
FE + RE intercept for: GP practice	−0.01	−0.80 to 0.78	0.98	0.004	0.29	13,530.30
FE + RE intercept and slope for: GP practice	−0.01	−0.80 to 0.78	0.98	Intercept: practice = 0.002 Slope: baseline PCS < 0.001 Age < 0.001	0.95	13,534.29
FE + RE intercept for: PCT and GP practice	−0.01	−0.80 to 0.78	0.98	Intercept: PCT = 0.005 Practice = 0.005	0.07	13,535.00
FE + RE intercept and slope for: PCT and GP practice	−0.01	−0.80 to 0.78	0.97	Intercept: PCT < 0.001 Practice = 0.002 Slope: baseline PCS < 0.001 Age < 0.001	0.35	13,541.72

: FE, fixed effect; LR test, likelihood ratio test; RE, random effect.
a: Adjusted for outcome baseline, sex, age, referral problem, PCT.

TABLE 19

Secondary health-related outcomes at baseline, 6 weeks or 6 months

Outcome (higher value is better outcome except where specified)	Mean (SD) or percentage, sample size					Regression analysis^a
	Usual care		PhysioDirect		Difference in means	Regression analysis^a
	Mean (SD)	n	Mean (SD)	n	Difference in means	95% CI	p-value
MYMOP (lower value is better outcome)
Baseline	3.80 (0.99)	743	3.84 (0.99)	1504
6 Weeks	2.92 (1.21)	561	2.76 (1.28)	1101	−0.19	−0.30 to −0.07	0.001
6 months	2.40 (1.38)	518	2.40 (1.43)	1033	−0.02	−0.16 to 0.11	0.73
EQ-5D
Baseline	0.56 (0.29)	731	0.53 (0.30)	1480
6 weeks	0.64 (0.26)	554	0.64 (0.27)	1080	0.01	−0.01 to 0.03	0.29
6 months	0.69 (0.27)	508	0.69 (0.27)	1020	0.01	−0.02 to 0.03	0.61
Global improvement score
Baseline	NA		NA		NA	NA	NA
6 weeks	3.54 (1.19)	552	3.69 (1.28)	1089	0.15	0.02 to 0.28	0.02
6 months	4.07 (1.40)	501	4.01 (1.44)	1001	−0.08	−0.23 to 0.08	0.32
OMERACT-OARSI
Baseline	NA		NA		NA	NA	NA
6 weeks	22.6%	124/550	28.2%	306/1085	1.37	1.08 to 1.75	0.01
6 months	38.6%	197/510	41.8%	430/1029	1.14	0.92 to 1.43	0.24

: NA, not applicable.
a: Adjusting for baseline outcome, age, gender, referral problem, PCT.

TABLE 20

SF-36v2 scale scores at baseline, 6 weeks or 6 months

Outcome	Baseline				6 weeks				6 months				Regression analysis^a
	Usual care		PhysioDirect		Usual care		PhysioDirect		Usual care		PhysioDirect		Regression analysis^a
	Mean (SD)	n	Mean (SD)	n	Mean (SD)	n	Mean (SD)	n	Mean (SD)	n	Mean (SD)	n	Arm difference	95% CI	p-value
PCS	37.7 (8.6)	743	36.8 (8.9)	1504	41.8 (10.3)	653	41.6 (10.3)	1332	44.2 (10.8)	629	43.5 (10.9)	1283	0.42	−0.28 to 1.12	0.24
PCS	37.7 (8.6)	743	36.8 (8.9)	1504	41.8 (10.3)	653	41.6 (10.3)	1332	44.2 (10.8)	629	43.5 (10.9)	1283	−0.01	−0.79 to 0.78	0.98
MCS	45.7 (13.3)	743	46.1 (12.6)	1504	48.7 (12.2)	653	48.7 (12)	1332	48.7 (11.8)	629	49 (11.9)	1283	−0.03	−0.88 to 0.82	0.94
MCS	45.7 (13.3)	743	46.1 (12.6)	1504	48.7 (12.2)	653	48.7 (12)	1332	48.7 (11.8)	629	49 (11.9)	1283	0.11	−0.83 to 1.05	0.82
Physical functioning	39.9 (10.2)	743	39.3 (10.4)	1506	43.0 (10.8)	656	43.0 (10.9)	1338	45.2 (10.8)	632	44.7 (11.2)	1284	0.52	−0.19 to 1.23	0.14
Physical functioning	39.9 (10.2)	743	39.3 (10.4)	1506	43.0 (10.8)	656	43.0 (10.9)	1338	45.2 (10.8)	632	44.7 (11.2)	1284	0.00	−0.75 to 0.75	1.00
Role-physical	37.4 (11.2)	743	36.7 (10.9)	1502	43.2 (11.6)	655	43.0 (11.3)	1336	45.5 (11.5)	630	45.0 (11.5)	1284	0.27	−0.60 to 1.15	0.52
Role-physical	37.4 (11.2)	743	36.7 (10.9)	1502	43.2 (11.6)	655	43.0 (11.3)	1336	45.5 (11.5)	630	45.0 (11.5)	1284	−0.08	−1.00 to 0.84	0.86
Bodily pain	34.9 (8.2)	743	34.6 (8.2)	1506	41.1 (9.6)	657	40.9 (9.9)	1338	43.2 (10.5)	632	43.1 (10.6)	1284	0.06	−0.68 to 0.80	0.89
Bodily pain	34.9 (8.2)	743	34.6 (8.2)	1506	41.1 (9.6)	657	40.9 (9.9)	1338	43.2 (10.5)	632	43.1 (10.6)	1284	0.04	−0.81 to 0.90	0.93
General health	45.1 (10.5)	743	44.6 (10.7)	1506	45.9 (10.5)	657	45.3 (10.8)	1338	46.1 (10.6)	634	45.7 (11.1)	1284	−0.07	−0.66 to 0.51	0.81
General health	45.1 (10.5)	743	44.6 (10.7)	1506	45.9 (10.5)	657	45.3 (10.8)	1338	46.1 (10.6)	634	45.7 (11.1)	1284	−0.14	−0.79 to 0.51	0.66
Vitality	43.7 (10.6)	743	43.4 (10.7)	1506	46.3 (10.8)	655	46.3 (10.8)	1334	47.4 (10.5)	632	47.0 (11.1)	1283	0.35	−0.40 to 1.11	0.35
Vitality	43.7 (10.6)	743	43.4 (10.7)	1506	46.3 (10.8)	655	46.3 (10.8)	1334	47.4 (10.5)	632	47.0 (11.1)	1283	−0.23	−1.05 to 0.60	0.59
Social functioning	40.4 (12.8)	743	39.8 (12.6)	1504	45.1 (12.2)	657	45.0 (12.4)	1338	46.1 (12.0)	632	46.2 (12.2)	1284	0.25	−0.69 to 1.18	0.58
Social functioning	40.4 (12.8)	743	39.8 (12.6)	1504	45.1 (12.2)	657	45.0 (12.4)	1338	46.1 (12.0)	632	46.2 (12.2)	1284	0.34	−0.61 to 1.30	0.48
Role-emotional	42.1 (14.6)	743	42.3 (14.3)	1498	46.6 (12.7)	655	46.2 (12.9)	1334	47.1 (12.2)	630	47.1 (12.4)	1283	−0.32	−1.24 to 0.59	0.51
Role-emotional	42.1 (14.6)	743	42.3 (14.3)	1498	46.6 (12.7)	655	46.2 (12.9)	1334	47.1 (12.2)	630	47.1 (12.4)	1283	−0.06	−1.07 to 0.95	0.92
Mental health	45.4 (11.7)	743	45.8 (11.4)	1506	47.9 (11.4)	655	48.2 (11.2)	1334	48.3 (11.44)	632	48.7 (11.3)	1283	0.24	−0.55 to 1.02	0.57
Mental health	45.4 (11.7)	743	45.8 (11.4)	1506	47.9 (11.4)	655	48.2 (11.2)	1334	48.3 (11.44)	632	48.7 (11.3)	1283	0.18	−0.67 to 1.04	0.72

a: Adjusting for baseline outcome, age, gender, referral problem, PCT at 6 weeks and 6 months.

TABLE 21

Time lost from work due to either medical condition or trial-related treatment

Owing to	Time off work and arm-time ratio
	Baseline						Baseline to 6 weeks						Baseline to 6 months
	Usual care		PhysioDirect		Arm-time ratio	p-value	Usual care		PhysioDirect		Arm-time ratio	p-value	Usual care		PhysioDirect		Arm-time ratio	p-value
	Mean (SD), median (IQR)	n	Mean (SD), median (IQR)	n	Arm-time ratio	p-value	Mean (SD), median (IQR)	n	Mean (SD), median (IQR)	n	Arm-time ratio	p-value	Mean (SD), median (IQR)	n	Mean (SD), median (IQR)	n	Arm-time ratio	p-value
Condition (days)	3.10 (7.72), 0 (0 to 2)	395	3.00 (7.53), 0 (0 to 2)	866	−0.2, (−1.12 to 0.63)	0.64	5.35 (15.22), 0 (0 to 2)	253	4.39 (11.44), 0 (0 to 2)	511	−0.95, (−3.02 to 1.05)	0.27	7.14 (22.24), 0 (0 to 2),	200	7.01 (18.03), 0 (0 to 3)	390	0.08, (−3.21 to 3.35)	0.94
Physiotherapy (hours)	NA		NA		NA		0.40 (1.21), 0 (0 to 0)	656	0.40 (2.35), 0 (0 to 0)	1340	−0.01 (−0.14 to 0.18)	0.94	0.98 (2.80), 0 (0 to 0),	598	0.95 (4.73), 0 (0 to 0)	1211	−0.04 (−0.37 to 0.33)	0.85

: NA, not applicable.
a: Arm-time ratio adjusted for baseline outcome, age, sex, referral problem, PCT.
: The possible differences between trial arms were estimated as time ratio between them through an Accelerated Failure Time model.

TABLE 22

Preference for usual care, PhysioDirect or neither

Preference	Percentages and multinomial logistic analysis^a
	Baseline		6 months		Risk rate ratio
	Usual care (n = 731)	PhysioDirect (n = 1462)	Usual care (n = 485)	PhysioDirect (n = 985)	Risk rate ratio
None	31.74	33.72	22.47	17.77	Ref.
Usual care	32.97	30.71	50.52	42.34	1.10 (95% CI 0.82 to 1.48); p = 0.53
PhysioDirect	35.29	35.57	27.01	39.90	1.98 (95% CI 1.43 to 2.74); p < 0.001

: Ref., reference.
a: Adjusting for baseline preference, baseline primary outcome, age, sex, referral problem, PCT.
: The difference between arms on preference is expressed as risk rate ratio with ‘no preference’ as reference.

TABLE 23

Consultation, access and overall satisfaction levels

Satisfaction	Time point	Arm				Regression analysis^a
		Usual care		PhysioDirect		Arm difference	95% CI	p-value
		Mean (SD)	n	Mean (SD)	n	Arm difference	95% CI	p-value
Consultation^b	6 weeks	82.5 (17.6)	378	77.6 (18.7)	890	−4.9	−7.1 to −2.7	< 0.001
Consultation^b	6 months	79.2 (19.2)	368	75.7 (20.1)	750	−3.4	−5.9 to 0.97	0.005
Access^a	6 weeks	71.4 (21.1)	381	70.6 (22.3)	869	−0.8	−3.4 to 1.7	0.502
Access^a	6 months	69.1 (20.8)	367	69.2 (22.0)	740	0.1	−2.7 to 2.8	0.960
Overall^a	6 weeks	83.7 (25.2)	383	77.3 (27.4)	885	−6.5	−9.6 to −3.4	< 0.001
Overall^a	6 months	79.7 (26.5)	367	75.9 (28.3)	739	−3.8	−7.3 to −0.3	0.031

a: Adjusting for baseline outcome, age, gender, referral problem, PCT.
b: Higher scores indicated greater satisfaction. Scores are rescaled as a percentage of the maximum possible score.

TABLE 24

Opinions of waiting time for physiotherapy from free-text comments on 6-week questionnaire

Item	Usual care, n/N (%)	PhysioDirect, n/N (%)
Those who made a free-text comment about things which were good, and/or things which could be improved	374/743 (50%)	777/1056 (74%)
Had received physiotherapy care (from comment)	264/374 (70%)	659/777 (85%)
Still waiting for physiotherapy care (from comment)	73/374 (20%)	45/777 (6%)
Uncertain (from comment) whether or not had had physiotherapy care	37/374 (10%)	73/777 (9%)
Those who commented specifically on waiting time	117/374 (31%)	215/777 (28%)
Positive about waiting time	17/117 (15%)	131/215 (61%)
Negative about waiting time	99/117 (85%)	80/215 (37%)
Positive and negative about waiting time	1/117 (1%)	4/215 (2%)
% of those commenting negatively about waiting time who were (from comment) still waiting for physiotherapy care	40/99 (40%)	19/80 (24%)

TABLE 25

Opinions of waiting time for physiotherapy from free-text comments on 6-month questionnaire

Item	Usual care, n/N (%)	PhysioDirect, n/N (%)
Those who made a free-text comment about things which were good, and/or things which could be improved	348/743 (47%)	670/1056 (63%)
Had received physiotherapy care (from comment)	308/348 (89%)	584/670 (87%)
Still waiting for physiotherapy care (from comment)	12/348 (3%)	12/670 (2%)
Uncertain (from comment) whether or not had had physiotherapy care	28/348 (8%)	74/670 (11%)
Those who commented specifically on waiting time	98/348 (28%)	157/670 (24%)
Positive about waiting time	26/98(27%)	109/157(69%)
Negative about waiting time	70/98 (71%)	44/157 (28%)
Positive and negative about waiting time	2/98 (2%)	4/157 (3%)
% of those commenting negatively about waiting time who were (from comment) still waiting for physiotherapy care	3/70 (4%)	2/44 (5%)

TABLE 26

Subgroup analyses of SF-36 PCS score at 6 months according to baseline age and presenting complaint

Subgroups at 6 months	SF-36v2 PCS				Randomisation– subgroup interaction^a^,^b	95% CI	p-value
	Usual care		PhysioDirect
	Mean	SD	Mean	SD
Age (years)
18 to < 25	47.6	10.8	47.3	9.1	Ref.		0.59
25 to < 35	49.6	8.1	48.4	9.4	−0.04	−3.79 to 3.71
35 to < 45	47.1	10.7	45.7	9.5	−0.92	−4.54 to 2.70
45 to < 55	44.3	10.9	44.5	10.3	1.34	−2.29 to 4.97
55 to < 65	42.5	9.9	41.4	11.7	0.78	−2.79 to 4.35
65 to < 75	39.2	10.2	39.6	11.2	1.03	−2.74 to 4.79
75 to < 85	35.9	10.1	35.4	8.7	2.01	−2.45 to 6.47
85 to < 95	36.3	7.5	28.3	9.3	−2.67	−9.68 to 4.35
Site of problem
Cervical	43.8	9.9	42.7	10.5	Ref.		0.28
Thoracic	42.3	13.8	42.9	11.9	3.85	−4.00 to 1.70
Lumbar	44.1	10.9	42.2	10.5	1.35	−1.27 to 3.96
Upper limb	44.6	10.7	45.2	11.0	2.59	0.08 to 5.09
Lower limb	45.0	10.9	44.2	10.8	0.14	−2.32 to 2.59
Widespread pain	33.8	11.5	37.7	12.4	4.76	−3.88 to 3.40
Multiple MSK	39.4	11.4	40.7	13.2	2.61	−2.12 to 7.33
Other MSK	42.8	14.9	41.1	14.2	3.39	−5.29 to 12.07

: Ref., reference.
a: Positive numbers indicate a greater benefit (in terms of SF-36v2 scale score) for patients in the specified age group or with the specified referral problem, which is greater than the benefit obtained by patients in the reference category.
b: Adjusted for baseline, sex, age, referral problem, PCT.

TABLE 27

Subgroup analyses of SF-36 PCS score at 6 months according to baseline socioeconomic status and PCT

Subgroups at 6 months	SF-36v2 PCS				Randomisation–subgroup interaction^a	95% CI	p-value
	Usual care		PhysioDirect
	Mean	SD	Mean	SD
Deprivation quintile (5 = most deprived)
1	46.7	10.0	45.0	10.7	Ref.		0.62
2	44.2	11.7	44.9	10.4	0.76	−2.44 to 3.97
3	45.5	9.4	44.4	10.7	−0.37	−3.42 to 2.69
4	43.6	11.2	42.5	11.1	−1.20	−4.41 to 2.00
5	41.0	11.2	39.8	11.2	−0.05	−3.51 to 3.40
PCT
Bristol	44.8	10.9	43.8	11.1	Ref.		0.78
Somerset	45.0	10.6	44.8	10.5	0.57	−1.46 to 2.59
Cheshire	44.0	10.7	43.0	11.2	0.88	−1.18 to 2.94
Stoke	42.3	11.2	41.7	10.7	1.00	−1.20 to 3.21

: Ref., reference.
a: Adjusted for baseline, sex, age, referral problem, PCT.

TABLE 28

Descriptive statistics for SF-36v2 PCS at baseline, 6 weeks or 6 months by patient's main referral problem

Main referral problem	PCS at time
	Baseline		6 weeks		6 months
	Mean (SD)	n	Mean (SD)	n	Mean (SD)	n
Cervical	38.87 (8.45)	273	41.51 (10.64)	240	43.07 (10.30)	227
Thoracic	39.33 (8.98)	48	42.69 (10.45)	40	42.77 (12.18)	38
Lumbar	34.62 (8.56)	614	40.55 (10.27)	540	42.81 (10.68)	511
Upper limb	38.86 (8.43)	525	42.59 (9.69)	471	44.97 (10.87)	451
Lower limb	37.47 (8.81)	675	42.15 (10.34)	600	44.47 (10.83)	593
Widespread pain	30.21 (8.73)	15	32.88 (10.90)	14	36.18 (11.76)	13
Multiple MSK	35.18 (8.79)	82	40.29 (10.72)	67	40.30 (12.54)	67
Other MSK	38.55 (10.19)	14	45.38 (10.33)	12	41.71 (13.71)	11

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