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

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.RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are

Does the Use of a Handheld Fan Improve Chronic Dyspnea? A Randomized, Controlled, Crossover Trial

Dyspnea is a disabling distressing symptom that is common in advanced disease affecting millions of people worldwide. Current palliative strategies are partially effective in managing this symptom; facial cooling has been shown to reduce the sensation of breathlessness when induced in volunteers but has not been formally investigated in dyspnea associated with disease. The objective of this study was to investigate whether a handheld fan reduces the sensation of breathlessness in such patients, enhancing palliative approaches. The effectiveness of a handheld fan (blowing air across the nose and mouth) in reducing the sensation of breathlessness was assessed in patients with advanced disease. Fifty participants were randomized to use a handheld fan for five minutes directed to their face or leg first and then crossed over to the other treatment. The primary outcome measure was a decrease of greater than 1cm in breathlessness recorded on a 10 cm visual analog scale (VAS). There was a significant difference in the VAS scores between the two treatments, with a reduction in breathlessness when the fan was directed to the face (P=0.003). This study supports the hypothesis that a handheld fan directed to the face reduces the sensation of breathlessness. The fan was acceptable to participants: it is inexpensive, portable, enhances self-efficacy, and available internationally. It should be recommended as part of a palliative management strategy for reducing breathlessness associated with advanced disease

Results of a pilot investigation into a complex intervention for breathlessness in advanced chronic obstructive pulmonary disease (COPD): Brief report

Breathlessness is the most common devastating symptom of advanced chronic obstructive pulmonary disease (COPD). The Breathlessness Intervention Service (BIS) is a multidisciplinary service that uses both pharmacological and non-pharmacological evidence-based interventions to reduce the impact of the symptom. The results of a Phase II evaluation of the service are reported. Pretest - posttest analysis of non-randomized data was performed for 13 patients with severe advanced COPD referred to BIS. Mean VAS-Distress scores (primary outcome measure) decreased (improved) for the group between baseline and follow up suggesting a clinically significant improvement: 6.88 (SD = 2.50) to 5.25 (SD = 2.99). At an individual level, 11 of the 13 patients showed a decrease in their distress due to breathlessness, and for eight of these this was clinically significant (range of all decreases 0.3–7.1 cm). Changes in secondary outcome measures are also reported. The Breathlessness Intervention Service appears to reduce distress due to breathlessness among patients with advanced COPD. A Phase III fully-powered randomized controlled trial is warranted

A scoping review of information provided within degenerative cervical myelopathy education resources: Towards enhancing shared decision making.

BACKGROUND: Degenerative cervical myelopathy (DCM) is a chronic neurological condition estimated to affect 1 in 50 adults. Due to its diverse impact, trajectory and management options, patient-centred care and shared decision making are essential. In this scoping review, we aim to explore whether information needs in DCM are currently being met in available DCM educational resources. This forms part of a larger Myelopathy.org project to promote shared decision making in DCM. METHODS: A search was completed encompassing MEDLINE, Embase and grey literature. Resources relevant to DCM were compiled for analysis. Resources were grouped into 5 information types: scientific literature, videos, organisations, health education websites and patient information leaflets. Resources were then further arranged into a hierarchical framework of domains and subdomains, formed through inductive analysis. Frequency statistics were employed to capture relative popularity as a surrogate marker of potential significance. RESULTS: Of 2674 resources, 150 information resources addressing DCM were identified: 115 scientific literature resources, 28 videos, 5 resources from health organisations and 2 resources from health education websites. Surgical management was the domain with the largest number of resources (66.7%, 100/150). The domain with the second largest number of resources was clinical presentation and natural history (28.7%, 43/150). Most resources (83.3%, 125/150) were designed for professionals. A minority (11.3% 17/150) were written for a lay audience or for a combined audience (3.3%, 5/150). CONCLUSION: Educational resources for DCM are largely directed at professionals and focus on surgical management. This is at odds with the needs of stakeholders in a lifelong condition that is often managed without surgery, highlighting an unmet educational need