VISIÓN DEL ALUMNO 1. D ESCRIPCIÓN DEL ETC

Patient and carer dyads were randomly allocated to one of the two arms of the trial once baseline assessments were conducted. All of the 182 patients

176 and their carers received usual care provided by staff at the hospital from which they were recruited. All of the 92 patients and their carers randomised to the pain education intervention attended the face-to-face discussion which lasted for 30 minutes and received the leaflet immediately after randomisation. Of these, 59 participants received the phone call reminder intervention at week two. Due to poor telephone network coverage some participants did not receive a phone call (n=19) but had brief face-to-face contact with KN during their visit to the clinic at week two. Of the 59 participants who received a phone call, four also had face-to-face contact with me at the clinic where I reminded them to read the leaflet and clarified any questions they had.

7.5 Follow-up

Of the 182 patient/carer dyads randomised, 157 patient/carer dyads (86.26%) and a further 10 patients (without a carer) were successfully followed-up. Of the 15 patient/carer dyads lost to follow-up, 8 were from the pain education intervention group, and 7 were from the usual care group. Of the additional 10 carers lost to follow-up, 5 were from each arm of the study.

Follow-up assessments were collected from 79 patients/carer dyads allocated to the pain education intervention group and from 78 patients/carer dyads allocated to the usual care group. Follow-up assessments were also collected from 5 patients without a carer from each group.

177 The reasons for being lost to follow-up were various. In the pain education intervention group eight patient/carer dyads were lost to follow-up for the following reasons: two had no transport, four patients died before follow-up assessments, one patient/carer was untraceable and another patient/carer dyad had moved away to another centre. In the usual care group a total of seven patients/carer dyads were lost to follow-up for the following reasons:

four of them moved to another centre, two of them were untraceable and one patient was unwell therefore assessments could not be conducted. In each group a further five carers were lost to follow-up and the reasons were all similar; two carers from each group were too busy to accompany the patient to the hospital for follow-up assessments, and three from each group had no transport to cater for both the patient and the carer.

The reasons for loss to follow-up did not differ between the two groups except that in the intervention group four patients died, but no death was reported in the usual care group. As the intervention did not involve any invasive procedures it is unlikely that these were due to the intervention.

Of the 157 patient/carer dyads and 10 patients without a carer who completed the trial, complete data were available for all the outcomes with 100% response for all outcome scales. All outcomes were conducted at baseline and eight weeks after delivery of the intervention and transposed to a 0 to 100 scale with higher scores indicating a more ‘positive’ outcome;

hence a participant’s individual score represented a percentage of the best possible score for that outcome.

178 7.6 Primary outcome-average pain severity

The primary outcome measure for this trial was change in average pain severity between baseline and follow-up in the two arms of the trial measured by a sub-scale of the Brief Pain Inventory.

Both groups had an improved average pain severity at follow-up (Table 21). However those in the pain education group had a mean change of 40.95 (SD 23.78) while usual care group had a mean change of 19.27 (SD 25.27). Participants in the pain education group reported a greater improvement in severity of pain compared to those in the usual care group (mean difference 21.09, 95% confidence interval 16.56 to 25.63;

P<0.001). When adjustments were made for baseline average pain severity score, recruitment centre, age, gender and medication number, the result was similar (mean difference 21.25, 95% confidence interval 16.7 to 25.8; P <0.001). Regardless of the method of analysis used, the participants in the pain education intervention group appeared to have a greater improvement in pain severity than those in the usual care group.

179

Table 21 Primary outcome- average pain severity on the BPI-PS for pain education and usual care groups for patient participants

aLinear regression: controlling for baseline score, and recruitment centre.

bLinear regression: controlling for baseline score, recruitment centre, age, gender and medication number.

Outcome Pain education

(n=84)

Usual care (n=83)

Adjusted for baseline average pain severity and recruitment centre^a

Adjusted for baseline average pain severity, recruitment centre, age, gender and medication^b Mean difference (95%

CI)

P value Mean difference (95% CI) P value BPI-PS subscale

Mean (SD) average pain severity score

At baseline (n=182) 50.76 (24.86) 51.22 (27.1) At follow-up (n=167) 92.62 (8.23) 71.69 (21.18)

Mean change (SD) from baseline 40.95 (23.78) 19.27 (25.27) 21.09 (16.56 to 25.63) <0.001 21.25 (16.7 to 25.8) <0.001

180 7.7 Secondary outcomes (patients)

There were three secondary outcomes for the patients: pain interference with activities of daily living, patient pain knowledge of pain management, and quality of life. Table 22 presents secondary outcomes for the patients.

7.7.1 Pain interference

Both groups experienced improved pain interference score at follow-up:

mean difference 42.5 (SD 25.91) in the pain education group compared with 18.42 (SD 23.92) in the usual care group. Patient participants in the pain education group had significantly greater improvement on pain interference than the usual care group (mean difference 24.32, 95%

confidence interval 19.33 to 29.32; P<0.001). When adjusted for baseline pain interference score, recruitment centre, age, gender and medication number, the result was similar (mean difference 24.5, 95% confidence interval 19.61 to 29.38; P<0.001). In both analyses patient participants in the pain education intervention had a significantly greater improvement on pain interference with daily activities than patient participants in the usual care group.

7.7.2 Pain knowledge

Both groups reported improved pain knowledge: mean difference 25.63 (SD 15.5) in the pain education group compared with 6.32 (SD 11) in the usual care group. Patients in the pain education group reported greater

181 improvement in knowledge than patients in the usual care group (mean difference 20.05, 95% confidence interval 17.25 to 22.86; P<0.001). When adjusted for baseline patient pain knowledge score, recruitment centre, age, gender and medication number, the result was similar (mean difference 20.39, 95% confidence interval 17.51 to 23.27; P<0.001.

Patient participants in the pain education intervention group had significantly more knowledge of pain management than patient participants in the usual care group regardless of the method of analysis used.

7.7.3 Quality of life (palliative care outcomes)

At follow-up both the pain education group and the usual care group reported improved quality of life (palliative care outcomes), mean difference 45.44 (SD 22.58) in the pain education group compared with 14.46 (SD 18.77) in the usual care group. Patient participants in the pain education group experienced a better quality of life than participants in the usual care group (mean difference 28.32, 95% confidence interval 24.12 to 32.53; P<0.001). After adjustments were made for baseline quality of life score, recruitment centre, age, gender and medication number, the result was similar (mean difference 28.76, 95% confidence interval 24.62 to 32.91; P<0.001). In both analyses patient participants in the pain education intervention group had significantly a better quality of life than participants in the usual care group.