TABLE 5

Clinical and patient-reported outcome measures: key secondary outcomes

Secondary outcomeControl armIntervention armAdjusted difference in means (95% CI)aDirection of positive effectStandardised effect size
N Mean (SD) N Mean (SD)
Key secondary outcomes
Normative adherence (%)29534.9 (31.7)29352.9 (31.4)9.5 (8.6 to 10.4)Increase0.29
FEV1% predicted (%)28256.9 (23.0)27460.6 (24.2)1.4 (–0.2 to 3.0)Increase0.06
BMI (kg/m2)28222.6 (4.1)27323.1 (4.4)0.3 (0.1 to 0.6)Increase0.07
Patient-reported outcomes
Beliefs about medication
 Concerns2712.1 (0.5)2632.0 (0.5)–0.2 (–0.2 to –0.1)Decrease0.29
 Necessities2713.5 (0.7)2633.7 (0.8)0.1 (0.0 to 0.2)Increase0.18
SRBAI (habit)27111.7 (4.9)26112.9 (4.9)1.2 (0.5 to 1.8)Increase0.24
CFQ-R
 Physical27452.6 (30.6)26455.8 (30.2)2.3 (–1.0 to 5.6)Increase0.08
 Emotion27466.5 (24.7)26466.6 (22.9)0.2 (–2.9 to 3.2)Increase0.01
 Social27459.6 (20.0)26460.5 (20.0)0.3 (–2.2 to 2.7)Increase0.01
 Eating27481.0 (23.2)26484.0 (21.5)1.9 (–1.3 to 5.2)Increase0.09
 Body image27465.1 (29.3)26467.2 (27.3)1.7 (–1.4 to 4.8)Increase0.06
 Treatment burden27451.6 (19.7)26556.6 (19.5)3.9 (1.2 to 6.7)Increase0.20
 Respiratory27156.6 (21.9)26358.0 (22.5)0.7 (–2.4 to 3.8)Increase0.03
 Digestion27280.2 (21.6)26380.4 (19.4)1.1 (–1.7 to 3.9)Increase0.05
MAD-3 (medication adherence)2459.9 (3.6)23710.8 (3.3)0.7 (0.2 to 1.2)Increase0.20
Behavioural question (effort)2703.0 (1.2)2603.3 (1.3)0.3 (0.1 to 0.5)Increase0.22
Subjective adherence26765.6 (32.8)25868.6 (31.3)1.9 (–2.8 to 6.6)0.06
CHAOS-6 (routine)2729.6 (3.2)2639.4 (3.4)–0.2 (–0.6 to 0.3)Decrease0.05
PAM-13 (health-style assessment)27464.9 (13.0)26568.1 (15.6)3.4 (1.3 to 5.4)Increase0.23
PHQ-8 (depression)2726.4 (5.0)2626.3 (5.6)–0.1 (–0.8 to 0.7)Decrease0.01
GAD-7 (anxiety)2734.5 (4.8)2624.9 (5.3)0.3 (–0.4 to 1.0)Decrease0.05
EQ-5D-5L2720.81 (0.18)2640.84 (0.15)0.01 (–0.01 to 0.04)Increase0.09
a

All analyses adjusted for previous year’s i.v. therapy-days, site and the outcome measure value at baseline.

Reproduced with permission from Wildman.44 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The table includes minor additions and formatting changes to the original table.

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From: Work packages 3.2, 3.3 and 3.4: full-scale randomised controlled trial with concurrent process evaluation

Cover of An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT
An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT.
Programme Grants for Applied Research, No. 9.11.
Wildman MJ, O’Cathain A, Hind D, et al.
Southampton (UK): NIHR Journals Library; 2021 Oct.
Copyright © 2021 Wildman et al. This work was produced by Wildman et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.
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