Skip to main content

Table 1 Secondary clinical outcomes

From: Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

Secondary outcomes

Body Mass Index (BMI).

Forced expiratory volume in 1 s (FEV1): standardised spirometry as a measure of condition severity [100].

EuroQol EQ-5D-5 L: generic health status measure for health economic analysis [101].

The Patient Activation Measure (PAM-13): assessment of patient knowledge, skill, and confidence for self-management [102]. Elements of the PAM-13 map to logic model constructs #29 and #30.

Confusion, Hubbub, and Order Scale (CHAOS 6-item): measure of life chaos [103]. Elements of the CHAOS-6 map to logic model construct #32.

Medication Adherence Data-3 items (MAD-3). Bespoke questionnaire adapted from the Medication Adherence Reporting Scale [104]:

1. I forget to take my nebuliser treatment (Always/Often/Sometimes/Rarely/Never)

2. I take fewer nebuliser treatments than my doctor recommends (Always/Often/ Sometimes/Rarely/Never)

3. I decide to skip one or more of my nebuliser treatments (Always/Often/Sometimes/Rarely/Never)

Maps to logic model construct #28.

Self-Report Behavioural Automaticity Index (SRBAI) [105]. Maps to logic model construct #31.

Cystic Fibrosis Questionnaire-Revised (CFQ-R): disease specific health-related quality of life instrument [106].

The Patient Health Questionnaire depression scale (PHQ-8): severity measure for depressive disorders [107].

The General Anxiety Disorder 7-item anxiety scale (GAD-7): severity measure for anxiety [108];

The Capability Opportunity Motivation Behaviour Beliefs Questionnaire (COM- BMQ), incorporating the validated self-report Beliefs about Medicines Questionnaire - specific (Nebuliser adherence) (BMQ 21-item) [109], customised by the team to identify perceived necessities and concerns for nebuliser treatment. Elements of the COM-BMQ map to logic model constructs #7, #29 and#33.

Project-specific items on belief, intention and confidence

Subjective adherence single question: self-report estimate of adherence as a percentage. Maps to logic model construct #28.

Self-reported problems: identification of capability and opportunity barriers to nebuliser adherence. Maps to logic model construct #33.

Concomitant medications: bespoke instrument, designed for this research project.

Resource use form (inpatient IV days; routine clinic visits; unscheduled outpatient contacts; unscheduled inpatient stays).

Prescription: a monthly prescription check to both check for data transfer to CFHealthHub and review for an indication that the prescription has changed

Objective Adherence to prescribed medication

Any treatment with IV antibiotics