JURISPRUDENCIA EN RELACIÓN A LA DEBIDA

The study recruited 568 out of 506 (112.3%) of the required sample size from November 2009 to August 2011. Participants were recruited from 15 sites across England, Scotland and Wales, with an average recruitment of 38 participants (range from 5 to 99) per site, with nine sites recruiting > 30 participants. The participant involvement in the trial ended in August 2012, following completion of recruitment and follow-up.Figure 2shows that, after an initial lag phase, steady recruitment was achieved with no noticeable seasonal variation.

Table 1provides a breakdown of screeningfigures collected from all sites, in terms of number of invitations sent, number of‘yes’replies, number of home screening visits, number randomised and the proportion of recruits per 100 invites. The different approaches were used to varying extents: GP-based approaches being responsible for recruiting 158 out of 568 (27.8%) of randomised participants at a rate of 2.5 per 100 invites, and stroke register-based approaches recruiting 410 out of 568 (72.2%) of randomised participants at a rate of 8.5 per 100 invites. The stroke register data includes participants recruited at outpatient clinics.

Follow-up (CONSORT)

Figure 3shows the CONSORT diagram for the study. The identification of participants was from 11,126 invites, either by letters of invitations or face-to-face approach. The exact breakdowns were not recorded; however, the majority were by letter of invitation. We had‘yes’replies from 1448 out of 11,126 (13.0%) approaches to participate in the study with 9678 out of 11,126 (87%) either not responding or providing negative replies. We did not record the number of‘no’replies. After initial pre-consent screening, usually by telephone, a further 596 out of 11,126 (5.4%) were considered ineligible. The main reason for ineligibility

0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 October 2009 December 2009February 2010 April 2010June 2010 August 2010_{October 2010} December 2010February 2011 April 2011June 2011 August 2011 Number of participants Time period FIGURE 2 Recruitment rate.

was that the potential participants felt they got out of the house as much as they wished already. Therefore, 852 out of 11,126 (7.7%) had a further screening visit in their own home from the RA. Overall, 568 out of 852 (66.7%) were found to be eligible to take part. Of the 11,126 letters sent, 568 people were included (5.1%). Of the 284 out of 11,126 (2.6%) who did not enter the study, only 1 out of 11,126 (0.01%) explicitly refused to participate (owing to their desire to be in the intervention group only).

The baseline questionnaire was completed by 567 out of 568 (99.8%) participants, with the one outstanding being left with the participant and never being received by the study coordinating centre. Following randomisation, 287 out of 568 (50.5%) participants were allocated to the intervention group and 281 out of 568 (49.5%) to the control group. In the control group, 1 out of 281 (0.4%) participants received two intervention visits in error. In the intervention group, 281 out of 287 (97.9%) of participants received at least one intervention visit. There was no evidence of crossover between the two groups. Six-month follow-up was measured by the receipt of the 6-month questionnaire booklet by the research team. For the intervention group, 264 out of 287 (92.0%) reached 6-month follow-up. Of the 23 out of 287 (8.0%) who did not reach 6-month follow-up, 3 out of 287 (1.0%) were lost to follow-up, 14 out of 287 (4.9%) withdrew consent and 4 out of 287 (1.4%) died. A further 2 out of 287 (0.7%) did not complete the follow-up but remained in the study, with 266 participants remaining in the intervention group after 6-month follow-up. For the control group, 239 out of 281 (85.1%) reached 6-month follow-up. Of the 42 out of 281 (14.9%) who did not reach 6-month follow-up, 8 out of 281 (2.8%) were lost to follow-up, 29 out of 281 (10.3%) withdrew consent and 5 out of 281 (1.8%) died. Therefore, there were 239 participants remaining in the control group after 6-month follow-up.

Completion of 6- and 12-month follow-ups was defined as return of the fully/partially completed questionnaire booklet to the NCTU. It does not indicate the level of completeness. Six- and 12-month results for individual measures presented later in the chapter indicate the number of participants from which we have analysable data.

There was a differential follow-up rate between the two groups for the 6-month follow-up, with 92.0% collected for the intervention group and 85.1% collected for the control group. However, these were both less than the predefined 20% attrition rates.

Successful data collection at 12-month follow-up was measured by receipt of the 12-month questionnaire booklet. For the intervention group, 232 out of 287 (80.8%) reached 12-month follow-up. Of the 34 out of 287 (266–232 = 34; 11.8%) who did not reach 12-month follow-up, 3 out of 287 (1.0%) were lost to follow-up, 17 out of 287 (5.9%) withdrew consent and 8 out of 287 (2.8%) died. A further 6 out of 287 (2.1%) did not complete the follow-up but remained in the study. For the control group 211 out of 281 (75.1%) reached 12-month follow-up. Of the 28 out of 281 (239–211 = 28; 10.0%) who did not reach 12-month follow-up, 4 out of 281 (1.4%) were lost to follow-up, 15 out of 281 (5.3%) withdrew consent and 7 out of 281 (2.5%) died. A further 2 out of 281 (0.7%) did not complete the 12-month follow-up but remained in the study.

TABLE 1 Breakdown of participant identification, screening and recruitment numbers from two alternative contact approaches Approach Invites ‘ Yes_’replies (% of invites) Screening visits (% of_‘yes_’replies) Randomised (% of_‘yes_’replies) Recruits/ 100 contacts GP database 6329 679 (10.7) 261 (38.4) 158 (23.3) 2.5 Stroke register 4797 769 (16.0) 591 (76.9) 410 (53.3) 8.5 Overall 11,126 1448 (13.0) 852 (58.8) 568 (39.2) 5.1

As with the 6-month follow-up, there were differential follow-up rates between the two groups for the 12-month follow-up. A total of 232 out of 287 (80.8%) of questionnaires were collected for the intervention group and 211 out of 281 (75.1%) collected for the control group. Although the control group follow-up rate was within the defined 20% attrition rate, the overall number of participants with 12-month follow-up data (n= 443) was within the threshold to ensure that the study had adequate power.

Table 2summarises the results of who completed the questionnaire and indicates a consistent proportion of participants completed the questionnaires themselves, whereas at 6 and 12 months there were consistent completion rates for both carer and other (16% and approximately 37%, respectively). The

‘other’completions at baseline were due to the presence of the RA.

Patient invites sent (n = 11126)

Replied ‘yes’ to invite (n = 1448)

Had a screening visit (n = 852)

Did not meet inclusion criteria (n = 596)

No reply or replied ‘no’ (n = 9678)

Did not meet inclusion criteria (n = 283) Declined to participate (n = 1) Number randomised

(n = 568)

Allocated to intervention group (n = 287) Received intervention (n = 281) Did not receive intervention (n = 6)

No follow-up dataa (n = 2) Lost to follow-up (n = 3) Withdrew (n = 14) Deceased (n = 4) Lost to follow-up (n = 8) Withdrew (n = 29) Deceased (n = 5) No follow-up dataa (n = 6) Lost to follow-up (n = 3) Withdrawn (n = 17) Deceased (n = 8) No follow-up dataa (n = 2) Lost to follow-up (n = 4) Withdrawn (n = 15) Deceased (n = 7) Allocated to control group (n = 281)

Received control (n = 281) Receive intervention (n = 6)

6-month follow-up (n = 264) 6-month follow-up (n = 239)

12-month follow-up (n = 232) Reached 12 months (n = 211)

Carer questionnaire follow-up

We received 192 carer questionnaires at baseline, with 100 out of 192 (52.1%) and 92 out of 192 (47.9%) from carers of participants in the intervention and control groups, respectively. We received 148 carer questionnaires at 6-month follow-up, with 84 out of 100 (84.8%) and 64 out of 92 (69.6%) from carers of participants in the intervention and control groups, respectively. We received 127 carer questionnaires at 12-month follow-up, with 71 out of 100 (71.0%) and 56 out of 92 (60.9%) from carers of participants in the intervention group and control, respectively.

Travel diary follow-up

Owing to the volume of travel diaries and the challenges of tracking their status, a decision was taken not to send reminders if the travel diary was not received. Overall, 70.6% of all expected travel diary months were received and assigned, regardless of whether they contained data, to 508 out of 568 (89.4%) of participants (Table 3); 73.6% were received for the intervention group and 67.5% from the control group. Overall, 55.1% of participants returned diaries for the full 12 months.