H: Recopilación de problemas detectados por el grupo de control
I: Problemas identificados por cada evaluador del grupo experimental
Phase 2 suggests that it is feasible to conduct a definitive trial. Nonetheless, based on the results of phase 2, Table 42 presents proposed recommended changes to main trial components and their estimated impact.
TABLE 42 Recommendations for improving trial parameters
Parameter Recommendations Rationale Impact
Screening None Screening rate compares favourably with those of other studies; CRC nurses screened 79% (n= 156) of all surgical CRC patients for eligibility
–
Eligibility Remove language as exclusion criterion
A multicentred study is likely to include areas in which English is not the first language for some people
We do not envisage a significant impact on eligibility rate
Exclude people already meeting recommended levels of physical activity
People meeting recommended levels of physical activity will already be maximising their chances of obtaining the health benefits associated with post-diagnosis physical activity. It does not seem a good use of resource, therefore, to include these people
This change in criteria is likely to reduce the eligibility rate because studies suggest that approximately 40% of people with CRC are meeting recommended levels for physical activity
In addition, our study shows that most participants were nearly meeting or were meeting recommended levels for physical activity and therefore greater efforts will have to be made to include those who are less active. To apply this eligibility criterion in any future study, patients could be screened using a self-report physical activity questionnaire to assess current physical activity Include people with poor
mobility
The study shows that the main reason nurses excluded people with CRC was poor mobility (35%). However, most cardiac rehabilitation services
accommodate people with poor mobility, including people who use a wheelchair. Cardiac rehabilitation also accommodates people with poor physical health (e.g. a low-intensity class for people who are in poor physical health)
This change to criteria should impact on eligibility rate by approximately 35%
TABLE 42 Recommendations for improving trial parameters (continued )
Parameter Recommendations Rationale Impact
Consent Exclude people who are on active treatment, such as adjuvant chemotherapy
The study shows that one of the reasons why people with CRC who wanted to participate in the study changed their minds or why some participants who were randomised to the intervention group were unable to attend cardiac rehabilitation was because they did not feel able to exercise while on treatment. Changing the eligibility criteria should, therefore, remove this barrier to participation
This change to the criteria should not impact on eligibility rate but merely delay when people are invited to enter the study (i.e. post treatment). We estimate it will improve the consent rate by 20% (18% of those who were interested in participating changed their minds because they were having adjuvant therapy) and intervention adherence by 25% (25% of participants randomised to the intervention group did not complete cardiac rehabilitation because of ongoing treatment)
Completion Introduce evidence-based strategies to improve completion rates at follow-up including: monetary incentive and a ‘package’ of postal communication strategies with reminder letters
The study shows that 61% of participants completed final follow-up measures
Evidence is lacking about the actual impact of these strategies on completion rates. Based on other studies’ completion rates (80–90%), we estimate an improvement of 20–30% Missing accelerometer data Introduce strategies to improve accelerometer wear-time, such as training investigators to explain the importance of these data for the study to participants and providing individual feedback on level of physical activity recorded by the device
The study shows that 31% of accelerometer data sets were assessed as invalid. The main reasons were not wearing the device or not wearing it for long enough
There was variation across sites and one site hardly had any invalid accelerometer data sets. One possible reason is that the investigator in site 1 had a sports science background and therefore was familiar with measurement of physical activity and could explain how to wear these devices properly. We estimate 10% invalid accelerometer data sets in any future trial
Missing diagnostic information
Ensure that investigators request this information once it becomes available
Diagnostic and treatment information was recorded at screening and therefore some of the diagnostic information was unavailable at this time
We estimate 100% of diagnostic information will be recorded in any future trial
Intervention adherence
None There were genuine health-related reasons why people were unable to attend cardiac rehabilitation, and, of those who did attend, attendance rates were very good (range 75–142%)
Chapter 9 Phase 2 qualitative study
T
his chapter presents the findings of the qualitative study that was nested within the pilot RCT (phase 2). Interviews and focus groups about the feasibility and acceptability of trial procedures and of theintervention (i.e. the feasibility and acceptability of using cardiac rehabilitation for people with CRC) are presented and discussed from the perspectives of people with CRC and people with CHD, and cancer and cardiology clinicians.
Introduction
Qualitative methods are an essential part of a trial’s evaluation and particularly apt for exploring the feasibility and acceptability of trial components and the intervention as opposed to measuring outcomes. Qualitative methods in RCTs can be used to understand and improve main trial components, such as recruitment.164Qualitative methods can also be used to explore processes, contextual factors or
intervention characteristics and mechanisms that can aid the interpretation of trial outcomes.165
Nevertheless, qualitative studies as an embedded component of RCTs remain uncommon,166although
there has been a recent growth in use of qualitative methods under the auspices of the MRC
Collaboration and Innovation for Difficult or Complex Randomised Controlled Trials (ConDuCT) Hub.167–170 The phase 2 qualitative study nested within the pilot RCT explored participants’ and clinicians’ views and experiences of the main components of the trial and the intervention (i.e. cardiac rehabilitation). The specific aims were to investigate:
l the views and experiences of CRC participants of the main trial procedures (e.g. recruitment, randomisation)
l the views and experiences of cardiac rehabilitation as a feasible and acceptable rehabilitation programme for CRC from the perspectives of CRC participants, people with CHD attending cardiac rehabilitation, and cardiac rehabilitation clinicians and CRC nurse specialists.
We have used the COnsolidated criteria for REporting Qualitative research, a 32-item checklist for interviews and focus groups,171to guide the structure of this chapter.