Self-efficacy outlined in chapter one is a person’s self-perceived belief in achieving desired outcomes and is frequently referred to in terms of control in managing the symptoms of a disease (198). It provides a simple framework from which to evaluate progress in acquiring confidence in self-management behaviours and has been used in the evaluation of bronchiectasis self-management (272). The 6-item Self-Efficacy Measure for Chronic Disease (SEMCD) (293) was chosen by our public and patient advisors as being succinct (0ne page) and easy to complete with only six questions each measured on a ten point scale evaluating confidence. 154 participants would give 80% power to detect a treatment difference (two sided 5% significance) of 1 unit of the SEMCD with a standard deviation of 2.2 units. Self-report questionnaires received by participants every 3 months for a year measured quantitative outcomes. Secondary outcomes measured included St George’s Respiratory Questionnaire (SGRQ) (294), validated in bronchiectasis(295) (296), the EuroQol-5D 3 level version (EQ-5D-3L) (297), and cost questionnaires. The Lung Information Needs Questionnaire (LINQ) (298) assessed knowledge and behaviour and is validated for chronic obstructive pulmonary disease. Participants also received non-validated questionnaires evaluating knowledge and confidence in managing bronchiectasis, particularly exacerbations and the design/presentation of BET. The number of exacerbations of bronchiectasis (42), medical contacts and sputum analyses were obtained from cost questionnaires and hospital records. Feasibility and acceptability of BET was investigated qualitatively through focus groups at the end of the study (299).
Page 65 of 288 The hospitals involved included one bronchiectasis specialist centre with bronchiectasis specialist nursing support, 4 district general hospitals with specialist respiratory nursing support and 1 community hospital located within East Anglia, UK. Participation was for a twelve month period and outcomes were measured as changes from baseline. Study recruitment was conducted from May 2013 to April 2015 with follow-up the study completed in April 2016.
Eligible participants were randomised to the intervention or control groups on a 1:1 basis using a computer generated code created by the study statistician with stratification according to hospital centre and severity of disease (four or more exacerbations in the last 12 months versus less than four) code concealment in sequential opaque envelopes. Unblind researcher CB enrolled participants and assigned sequential envelopes.
Participants randomised to the intervention received the BET document (48 pages) plus education provided by researcher CB (to promote standardisation and reduce the chance of cross-contamination of the control group) via four brief semi-structured telephone interactions including how to use the action plan, information, monitoring and reference sections.
Participants were encouraged to practice using the tool and ask questions, a contact number was provided for information about the study and use of BET (not for clinical queries). Participants’ healthcare providers were informed of their participation within the trial. No additional care was provided to the treatment as usual comparison group who continued to be guided by their usual health practitioners at routine appointments.
Page 66 of 288
Figure 5 BET enrolment and retention
Enrolment Assessed for eligibility n= 1351
Exclusions: n= 1002 Declined n= 30 Declined n= 73 Declined n= 11 Declined n= 14 Total Declined 128 n= 1 Total Excluded n= 1131 n= 220 Allocation
BET Intervention n= 109 Treatmentas usual n= 111 received 3 or more of
the telephone education sessions
n= 106 Did not receive
intervention. Reason: Never returned baseline questionnaires n= 3 Follow-up
Withdrew Too busy n= 2 Withdrew Too busy n= 1 Withdrew Study too much for them n= 0 Withdrew Study too much for them n= 2 Withdrew Too poorly n= 2 Withdrew Too poorly n= 2 Withdrew Too mild n= 1 Withdrew Too mild n= 0 Withdrew Low, dissengaged n= 0 Withdrew Low, dissengaged n= 1 Withdrew Bereavement n= 0 Withdrew Bereavement n= 1 Withdrew Caring for relative (all needs) n= 1 Withdrew Caring for relative (all needs) n= 0 Withdrew Left to take part in a medicinal study n= 1 Withdrew Left to take part in a medicinal study n= 1 Withdrew Left for University n= 1 Withdrew Left for University n= 0 Withdrew Offshore n= 1 Withdrew Offshore n= 0 Withdrew RIP n= 4 Withdrew RIP n= 4
Total Withdrawn n= 13 Total Withdrawn 12 n= 29 n= 39 Analysis n= 67 n= 60
Not meeting Inclusion criteria (prior to consent)
Lost to follow-up (no response to primary outcome at
12mths) not withdrawn Analysed for primary outcome
no reason given too poorly not interested
too busy screen fail (consented) no exacerbation (12mths)
Lost to follow-up (no response to primary outcome at
12mths) not withdrawn Analysed for primary outcome Randomised
Page 67 of 288 Data were double entered using Microsoft Excel software and discrepancies resolved by re-examining the source data. LINQ was analysed using the LINQ
Scoring Tool (www.linq.org.uk). The Bronchiectasis Aetiology Co-morbidity Index
was calculated from clinical data (56). Analysis was based on an intention-to-treat approach. Changes from baseline for primary and secondary endpoints was compared between groups using a general linear model adjusted for the stratification of severity used in the randomisation schedule. Total exacerbations and unscheduled care were both compared using negative binomial regression and reported as the incidence rate ratio which is the ratio of the event rates between the study arms. Adjusted analyses were undertaken with adjustment for baseline values of the outcomes. The analysis of LINQ subscales were based on a Mann- Whitney test as the values were not normally distributed.
Transcribed recordings of the semi-structured focus groups were reviewed in relation to personal self-management and the acceptability and utility of BET then analysed in parallel to increase rigour (300). Microsoft Office Excel and qualitative data analysis software (Nvivo11) were used to perform an inductive thematic analysis where patterns and clusters of linked data were organised into themes (301, 302)