Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2009 Jul 7:8:9.
doi: 10.1186/1472-684X-8-9.

The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

Morag C Farquhar  1 , Irene J Higginson, Petrea Fagan, Sara Booth
Affiliations

The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

Morag C Farquhar et al. BMC Palliat Care. .

Abstract

Background: The Breathlessness Intervention Service is a novel service for patients with intractable breathlessness regardless of aetiology. It is being evaluated using the Medical Research Council's framework for the evaluation of complex interventions. This paper describes the feasibility results of Phase II: a single-blinded fast-track pragmatic randomised controlled trial.

Methods: A single-blinded fast-track pragmatic randomised controlled trial was conducted for patients with chronic obstructive pulmonary disease referred to the service. Patients were randomised to either receive the intervention immediately for an eight-week period, or receive the intervention after an eight-week period on a waiting list during which time they received standard care. Outcomes examined included: response rates to the trial; response rates to the individual questionnaires and items; comments relating to the trial functioning made during interviews with patients, carers, referrers and service providers; and, researcher fieldwork notes.

Results: 16 of the 20 eligible patients agreed to participate in a recruitment visit (16/20); 14 respondents went on to complete a recruitment visit/baseline interview. The majority of those who completed a recruitment visit/baseline interview completed the RCT protocol (13/14); 12 of their carers were recruited and completed the protocol. An unblinding rate of 6/25 respondents (patients and carers) was identified. Missing data were minimal and only one patient was lost to follow up. The fast-track trial methodology proved feasible and acceptable. Two of the baseline/outcome measures proved unsuitable: the WHO performance scale and the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW).

Conclusion: This study adds to the evidence that fast-track randomised controlled trials are feasible and acceptable in evaluations of palliative care interventions for patients with non-malignant conditions. Reasonable response rates and low attrition rates were achieved. Further, with adequate preparation of the research and randomisation teams, clinicians, and responders, and effective liaison with the clinicians, single-blinding proved possible. Methods were identified to reduce unblinding through careful attention to the type of data collected at unblinded measurement points; the content of interviews should be carefully considered when designing blinded-trial protocols.

Trial registration: Clinical Trials.gov NCT00711438.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow chart depicting the follow up measurement points
Figure 2
Figure 2
CONSORT flow chart summarising the numbers for study enrolment, randomisation, allocation, follow up and analysis
See this image and copyright information in PMC

References

    1. Solano JP, Gomes B, Higginson IJ. A comparison of symptom prevalence in far advanced cancer, AIDS, heart disease, chronic obstructive pulmonary disease and renal disease. J Pain Symptom Manage. 2006;31:58–69. doi: 10.1016/j.jpainsymman.2005.06.007. - DOI - PubMed
    1. Corner J, Plant H, A'Hern R, Bailey C. Non-pharmacological intervention for breathlessness in lung cancer. Palliat Med. 1996;10:299–305. doi: 10.1177/026921639601000405. - DOI - PubMed
    1. Bredin M, Corner J, Krishnasamy M, Plant H, Bailey C, A'Hern R. Multicentre randomised control trial of nursing intervention for breathlessness in patients with lung cancer. BMJ. 1999;318:901–904. - PMC - PubMed
    1. Hately J, Laurence V, Scott A, Baker R, Thomas P. Breathlessness clinics within specialist palliative care settings can improve the quality of life and functional capacity of patients with lung cancer. Palliat Med. 2003;17:410–417. doi: 10.1191/0269216303pm752oa. - DOI - PubMed
    1. Connors S, Graham S, Peel T. An evaluation of a physiotherapy led non-pharmacological breathlessness programme for patients with intrathoracic malignancy. Palliat Med. 2007;21:285–287. doi: 10.1177/0269216307079172. - DOI - PubMed

Associated data