The importance of the feasibility study: Lessons from a study of the hand-held fan used to relieve dyspnea in people who are breathless at rest Development, effectiveness and cost-effectiveness of a new out-patient Breathlessness Support Service: study protocol of a phase III fast-track randomised controlled trial A Mixed-Methods, Randomized, Controlled Feasibility Trial to Inform the Design of a Phase III Trial to Test the Effect of the Handheld Fan on Physical Activity and Carer Anxiety in Patients With Refractory Breathlessness. Does the use of a handheld fan improve chronic dyspnea? A randomized, controlled, crossover trial. An exercise test to assess clinical dyspnoea: estimation of reproducibility and sensitivity. A randomised controlled trial to investigate the use of high-frequency airway oscillations as training to improve dyspnoea in COPD An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Study Protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease Effectiveness of the Assessment of Burden of Chronic Obstructive Pulmonary Disease (ABC) tool: study protocol of a cluster randomised trial in primary and secondary care Multicentre randomised controlled trial of nursing intervention for breathlessness in patients with lung cancer. Correlation of the degree of dyspnea with health-related quality of life, functional abilities, and diffusing capacity for carbon monoxide in patients with systemic sclerosis and active alveolitis: results from the Scleroderma Lung Study. Clinically important differences in the intensity of chronic refractory breathlessness. Breathlessness, functional status, distress, and palliative care needs over time in patients with advanced chronic obstructive pulmonary disease or lung cancer: a cohort study. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease A randomised trial of high vs low intensity training in breathing techniques for breathless patients with malignant lung disease: a feasibility study. The experience of using the SEIQoL-DW with patients with advanced chronic obstructive pulmonary disease (COPD): issues of process and outcome Dyspnoea assessed by visual analogue scale in patients with chronic obstructive lung disease during progressive and high intensity exercise.
Background : The dyspnea accompanying advanced cardiorespiratory disease is often refractory to palliation . It is disabling , distressing and associated with the diseases most common everywhere in the world . The h and -held fan , used to generate a draught across the face , is a simple , cost-effective , safe , and universally applicable palliative breathlessness intervention , consistently described as valuable in qualitative research . A previous crossover trial confirmed its benefit in patients breathless at rest , but the washout period was uncertain . Aim : To determine the washout period after use of the h and -held fan to inform accurate r and omized controlled trial design . Design : An observational method ological study . Breathlessness intensity was measured using 100 mm visual analog scale and numerical rating scale , and “ relief of breathlessness ” was measured on a 5-point scale . Those benefitting from the fan provided visual analog scale/numerical rating scale scores until ( 1 ) scores returned to baseline values or ( 2 ) until response had plateaued . The primary outcome measure was the time ( in minutes ) to reach either component of the primary study endpoint . Setting s/ participants : Four in-/out-patient hospice/hospital units ; participants had chronic refractory breathlessness using the fan . Results : Overall , 31 patients participated ( mean age : 74.8 years ; range : 49–98 years , st and ard deviation = 11.5 years ) ; 64 % were males . Approximately , half of the sample experienced benefit of moderate effect size . The relative reduction in breathlessness relative to the mean baseline score for the sample was 27 % for the visual analog scale and 19 % for the numerical rating scale . Conclusion : Feasibility work is essential , even for simple widely employed interventions Background Breathlessness is a common and distressing symptom affecting many patients with advanced disease both from malignant and non-malignant origin . A combination of pharmacological and non-pharmacological measures is necessary to treat this symptom successfully . Breathlessness services in various compositions aim to provide comprehensive care for patients and their carers by a multiprofessional team but their effectiveness and cost-effectiveness have not yet been proven . The Breathlessness Support Service ( BSS ) is a newly created multiprofessional and interdisciplinary outpatient service at a large university hospital in South East London . The aim of this study is to develop and evaluate the effectiveness and cost effectiveness of this multidisciplinary out – patient BSS for the palliation of breathlessness , in advanced malignant and non-malignant disease . Methods The BSS was modelled based on the results of qualitative and quantitative studies , and systematic literature review s. A r and omised controlled fast track trial ( RCT ) comprising two groups : 1 ) intervention ( immediate access to BSS in addition to st and ard care ) ; 2 ) control group ( st and ard best practice and access to BSS after a waiting time of six weeks ) . Patients are included if suffering from breathlessness on exertion or at rest due to advanced disease such as cancer , chronic obstructive pulmonary disease ( COPD ) , chronic heart failure ( CHF ) , interstitial lung disease ( ILD ) or motor neurone disease ( MND ) that is refractory to maximal optimised medical management . Both quantitative and qualitative outcomes are assessed in face to-face interviews at baseline , after 6 and 12 weeks . The primary outcome is patients ' improvement of mastery of breathlessness after six weeks assessed on the Chronic Respiratory Disease Question naire ( CRQ ) . Secondary outcomes for patients include breathlessness severity , symptom burden , palliative care needs , service use , and respiratory measures ( spirometry ) . For analyses , the primary outcome , mastery of breathlessness after six weeks , will be analysed using ANCOVA . Selection of covariates will depend on baseline differences between the groups . Analyses of secondary outcomes will include patients ’ symptom burden other than breathlessness , physiological measures ( lung function , six minute walk distance ) , and caregiver burden . Discussion Breathlessness services aim to meet the needs of patients suffering from this complex and burdensome symptom and their carers . The newly created BSS is different to other current services as it is run in close collaboration of palliative medicine and respiratory medicine to optimise medical care of patients . It also involves professionals from various medical , nursing , physiotherapy , occupational therapy and social work background .Trial registration Clinical Trials.gov ( NCT01165034 CONTEXT The h and held fan is an inexpensive and safe way to provide facial airflow , which may reduce the sensation of chronic refractory breathlessness , a frequently encountered symptom . OBJECTIVES To test the feasibility of developing an adequately powered , multicenter , multinational r and omized controlled trial comparing the efficacy of a h and held fan and exercise advice with advice alone in increasing activity in people with chronic refractory breathlessness from a variety of medical conditions , measuring recruitment rates ; data quality ; and potential primary outcome measures . METHODS This was a Phase II , multisite , international , parallel , nonblinded , mixed- methods r and omized controlled trial . Participants were central ly r and omized to fan or control . All received breathlessness self-management/exercise advice and were followed up weekly for four weeks . Participants /carers were invited to participate in a semistructured interview at the study 's conclusion . RESULTS Ninety-seven people were screened , 49 r and omized ( mean age 68 years ; 49 % men ) , and 43 completed the study .  Site recruitment varied from 0.25 to 3.3/month and screening : r and omization from 1.1:1 to 8.5:1 . There were few missing data except for the Chronic Obstructive Pulmonary Disease Self-Efficacy Scale ( two-thirds of data missing ) . No harms were observed . Three interview themes included 1 ) a fan is a helpful self-management strategy , 2 ) a fan aids recovery , and 3 ) a symptom control trial was welcome . CONCLUSION A definitive , multisite trial to study the use of the h and held fan as part of self-management of chronic refractory breathlessness is feasible . Participants found the fan useful . However , the value of information for changing practice or policy is unlikely to justify the expense of such a trial , given perceived benefits , the minimal costs , and an absence of harms demonstrated in this study CONTEXT 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 . OBJECTIVE The objective of this study was to investigate whether a h and held fan reduces the sensation of breathlessness in such patients , enhancing palliative approaches . METHODS The effectiveness of a h and held fan ( blowing air across the nose and mouth ) in reducing the sensation of breathlessness was assessed in patients with advanced disease . Fifty participants were r and omized to use a h and held 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 1 cm in breathlessness recorded on a 10 cm visual analog scale ( VAS ) . RESULTS 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 ) . CONCLUSION This study supports the hypothesis that a h and held 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 A new test for assessing clinical dyspnoea  with greater precision has been devised . This involves walking on a treadmill while ventilation is measured and dyspnoea is assessed serially with visual analogue scales . The test has been applied successfully in patients with chronic bronchitis and emphysema and in asthmatic patients . The reproducibility of the test was determined by comparing identical periods of exercise separated by an interval of five days in patients with chronic bronchitis and emphysema . The relationship between dyspnoea and ventilation showed acceptable within-patient reproducibility . The sensitivity of the test was investigated in asthmatic patients by comparing exercise after placebo and after salbutamol which had increased PEFR by a mean of 33 % . After salbutamol , lower breathlessness scores usually occurred for a given level of ventilation and this indicates that the test was sensitive enough to detect an effective treatment . Thus more precise assessment of dyspnoea in patients is feasible and generally reliable . However , a proportion of patients respond unpredictably and it is necessary to apply this test critically and with an appreciation of its limitations Introduction Chronic obstructive pulmonary disease ( COPD ) is characterised by expiratory flow limitation result ing in symptomatic dyspnoea , sputum retention and ventilation heterogeneity . Changes in breathing mechanics affect the ability of respiratory muscles to respond to the ventilatory dem and s , increasing the sensation of dyspnoea . A high-frequency airway oscillating device has been developed to combine respiratory muscle training and oscillations to improve dyspnoea and sputum retention within COPD . Methods and analysis Patients with symptomatic COPD ( Medical Research Council Breathlessness scale grade ≥2 ) will be recruited to a double-blind , r and omised , sham-controlled trial . Both groups will follow an 8-week intervention phase using the device three times per day for 5 min at a time . This will be recorded in a self-reported diary . The device applies a flow resistive load and oscillations for combined training . Those receiving the sham device will follow the same protocol ; however , the mechanism of action will be removed from the device . Improvements in the Chronic Respiratory Question naire-Dyspnoea domain will be the primary outcome measure . Secondary outcomes will explore respiratory muscle function , health-related quality of life , exercise capacity and physical activity . The Lung Clearance Index will be an exploratory outcome . Outcomes will be explored using the most appropriate statistical test , dependent on the sample distribution . Focus groups will be an exploratory outcome and analysed by thematic analysis . Ethics and dissemination Ethical approval has been obtained from the East Midl and s-Leicester South Research Ethics Committee and the trial has been registered through the IS RCT N Registry . The study results will be disseminated to the appropriate stakeholders through presentations , conferences and peer- review ed journals . A double-blind , placebo-controlled , r and omised trial investigating the effects of high-frequency airway oscillations  on dyspnoea , sputum , quality of life and exercise capacity in # COPD . BACKGROUND Breathlessness is a common and distressing symptom , which increases in many diseases as they progress and is difficult to manage . We assessed the effectiveness of early palliative care integrated with respiratory services for patients with advanced disease and refractory breathlessness . METHODS In this single-blind r and omised trial , we enrolled consecutive adults with refractory breathlessness and advanced disease from three large teaching hospitals and via general practitioners in South London . We r and omly allocated ( 1:1 ) patients to receive either a breathlessness support service or usual care . R and omisation was computer generated central ly by the independent Clinical Trials Unit in a 1:1 ratio , by minimisation to balance four potential confounders : cancer versus non-cancer , breathlessness severity , presence of an informal caregiver , and ethnicity . The breathlessness support service was a short-term , single point of access service integrating palliative care , respiratory medicine , physiotherapy , and occupational therapy . Research interviewers were masked as to which patients were in the treatment group . Our primary outcome was patient-reported breathlessness mastery , a quality of life domain in the Chronic Respiratory Disease Question naire , at 6 weeks . All analyses were by intention to treat . Survival was a safety endpoint . This trial is registered with Clinical Trials.gov , number NCT01165034 . FINDINGS Between Oct 22 , 2010 and Sept 28 , 2012 , 105 consenting patients were r and omly assigned ( 53 to breathlessness support service and 52 to usual care )  . 83 of 105 ( 78 % ) patients completed the assessment at week 6 . Mastery in the breathlessness support service group improved compared with the control ( mean difference 0·58 , 95 % CI 0·01 - 1·15 , p=0·048 ; effect size 0·44 ) . Sensitivity analysis found similar results . Survival rate from r and omisation to 6 months was better in the breathlessness support service group than in the control group ( 50 of 53 [ 94 % ] vs 39 of 52 [ 75 % ] ) and in overall survival ( generalised Wilcoxon 3·90 , p=0·048 ) . Survival differences were significant for patients with chronic obstructive pulmonary disease and interstitial lung disease but not cancer . INTERPRETATION The breathlessness support service improved breathlessness mastery . Our findings provide robust evidence to support the early integration of palliative care for patients with diseases other than cancer and breathlessness as well as those with cancer . The improvement in survival requires further investigation . FUNDING UK National Institute for Health Research ( NIHR ) and Cicely Saunders International Abstract Background Breathlessness in advanced disease causes significant distress to patients and carers and presents management challenges to health care professionals . The Breathlessness Intervention Service ( BIS ) seeks to improve the care of  breathless patients with advanced disease ( regardless of cause ) through the use of evidence -based practice and working with other healthcare providers . BIS delivers a complex intervention ( of non-pharmacological and pharmacological treatments ) via a multi-professional team . BIS is being continuously developed and its impact evaluated using the MRC 's framework for complex interventions ( Pre Clinical , Phase I and Phase II completed ) . This paper presents the protocol for Phase III . Methods / Design Phase III comprises a pragmatic , fast-track , single-blind r and omised controlled trial of BIS versus st and ard care . Due to differing disease trajectories , the service uses two broad service models : one for patients with malignant disease ( intervention delivered over two weeks ) and one for patients with non-malignant disease ( intervention delivered over four weeks ) . The Phase III trial therefore consists of two sub- protocol s : one for patients with malignant conditions ( four week protocol ) and one for patients with non-malignant conditions ( eight week protocol ) . Mixed method interviews are conducted with patients and their lay carers at three to five measurement points depending on r and omisation and sub- protocol . Qualitative interviews are conducted with referring and non-referring health care professionals ( malignant disease protocol only ) . The primary outcome measure is ' patient distress due to breathlessness ' measured on a numerical rating scale ( 0 - 10 ) . The trial includes economic evaluation . Analysis will be on an intention to treat basis . Discussion This is the first evaluation of a breathlessness intervention for advanced disease to have followed the MRC framework and one of the first palliative care trials to use fast track methodology and single-blinding . The results will provide evidence of the clinical and cost-effectiveness of the service , informing its longer term development and implementation of the model in other centres nationally and internationally . It adds to method ological developments in palliative care research where complex interventions are common but evidence sparse . Trial Registration Clinical Trials.gov : NCT00678405 IS RCT N : IS RCT Background Chronic Obstructive Pulmonary Disease ( COPD ) is a growing worldwide problem that imposes a great burden on the daily life of patients . Since there is no cure , the goal of treating COPD is to maintain or improve quality of life . We have developed a new tool , the Assessment of Burden of COPD ( ABC ) tool , to assess and visualize the integrated health status of patients with COPD , and to provide patients and healthcare providers with a treatment algorithm . This tool may be used during consultations to monitor the burden of COPD and to adjust treatment if necessary . The aim of the current study is to analyse the effectiveness of the  ABC tool compared with usual care on health related quality of life among COPD patients over a period of 18 months . Methods / Design A cluster r and omised controlled trial will be conducted in COPD patients in both primary and secondary care throughout the Netherl and s. An intervention group , receiving care based on the ABC tool , will be compared with a control group receiving usual care . The primary outcome will be the change in score on a disease-specific- quality -of-life question naire , the Saint George Respiratory Question naire . Secondary outcomes will be a different question naire ( the COPD Assessment Test ) , lung function and number of exacerbations . During the 18 months follow-up , seven measurements will be conducted , including a baseline and final measurement . Patients will receive question naires to be completed at home . Additional data , such as number of exacerbations , will be recorded by the patients ’ healthcare providers . A total of 360 patients will be recruited by 40 general practitioners and 20 pulmonologists . Additionally , a process evaluation will be performed among patients and healthcare providers . Discussion The new ABC tool complies with the 2014 Global Initiative for Chronic Obstructive Lung Disease guidelines , which describe the necessity to classify patients on both their airway obstruction and a comprehensive symptom assessment . It has been developed to classify patients , but also to provide visual insight into the burden of COPD and to provide treatment advice . Trial registration Netherl and s Trial Register , NTR3788 OBJECTIVE To evaluate the effectiveness of nursing intervention for breathlessness in patients with lung cancer . DESIGN Patients diagnosed with lung cancer participated in a multicentre r and omised controlled trial where they either attended a nursing clinic offering intervention for their breathlessness or received best supportive care . The intervention consisted of a range of strategies combining breathing control , activity pacing , relaxation techniques , and psychosocial support . Best supportive care involved receiving st and ard management and treatment available for breathlessness , and breathing assessment s. Participants completed a range of self assessment question naires at baseline , 4 weeks , and 8 weeks . SETTING Nursing clinics within 6 hospital setting s in the United Kingdom . PARTICIPANTS 119 patients diagnosed with small cell or non-small cell lung cancer or with mesothelioma who had completed first line treatment for their disease and reported breathlessness . OUTCOME MEASURES Visual analogue scales measuring distress due to breathlessness , breathlessness at best and worst , WHO performance status scale , hospital anxiety and depression scale , and Rotterdam symptom checklist . RESULTS The intervention group improved significantly at 8 weeks in 5 of the 11 items assessed : breathlessness at best , WHO performance status , levels of depression , and two Rotterdam symptom checklist measures ( physical symptom distress and breathlessness ) and showed slight improvement in 3 of the remaining 6 items . CONCLUSION Most patients who completed the study had a poor prognosis , and breathlessness was typically a symptom of their deteriorating condition . Patients who attended nursing clinics and received the breathlessness intervention experienced improvements in breathlessness , performance status , and physical and emotional states relative to control patients OBJECTIVE To determine whether baseline self- assessment measures of health status and physiologic indices of disease severity in alveolitis-positive patients with systemic sclerosis ( SSc ) correlate with the severity of their dyspnea , and to quantify functional impairment in patients with scleroderma lung disease and compare it with that in patients with chronic obstructive pulmonary disease ( COPD ) . METHODS SSc patients ( n = 138 ) with diffuse ( n = 81 ) or limited ( n = 57 ) cutaneous disease and active alveolitis ( determined by bronchoalveolar lavage and /or high-resolution computed tomography ) who participated in the National Heart , Lung , and Blood Institute-sponsored , multicenter , parallel-group , double-blind , r and omized , placebo-controlled trial of oral cyclophosphamide for treatment of SSc-associated interstitial lung disease were evaluated . Pearson 's univariate correlations were determined between the Short Form 36 ( SF-36 ) physical component summary ( PCS ) and mental component summary ( MCS ) scales , functional question naires , and physiologic parameters of breathing ( forced vital capacity [ FVC ] and single-breath diffusing capacity for carbon monoxide [ DLCO ] ) . Student 's t-test was used to compare subgroups . Scores from 2 instruments for self- assessment of breathlessness , Mahler 's baseline dyspnea index ( BDI ) and a visual analog scale ( VAS ) for breathing , were divided at the median . Values for the DLCO and FVC ( % predicted ) were divided based on the American Thoracic Society guidelines for mild ( > 70 % of predicted ) , moderate ( 50 - 70 % of predicted ) , and severe ( < 50 % of predicted ) physiologic impairment . RESULTS Scores on the BDI and VAS for breathing were highly correlated ( r = -0.61 ) . The PCS and MCS were able to differentiate patients with more breathlessness ( measured by BDI and VAS for breathing ) and more abnormal physiologic measures ( FVC and DLCO ) . In SSc patients with alveolitis , all 8 domains of the SF-36 were significantly impaired as compared with the healthy population and were similar to those reported by patients with COPD . CONCLUSION The SF-36 was able to discriminate between scleroderma lung disease patients with more severe and less severe breathlessness , the primary symptom of active alveolitis . The SF-36 complements the BDI and VAS scores for breathing in scleroderma lung disease and is variably correlated with results of pulmonary function tests , suggesting that the SF-36 should be included as an outcome measure in intervention trials in this population CONTEXT Clinical ly important differences in chronic refractory breathlessness are ill defined but important in clinical practice and trial design . OBJECTIVES To estimate the clinical relevance of differences in breathlessness intensity using distribution and patient anchor methods . METHODS This was a retrospective data analysis from 213 data sets from four clinical trials for refractory breathlessness .  Linear regression was used to explore the relationship between study effect size and change in breathlessness score ( 0 - 100 mm visual analogue scale ) and to estimate the change in score equivalent to small , moderate , and large effect sizes . Pooled individual blinded patient preference data from three r and omized controlled trials were analyzed . The difference between the mean change in Day 4 minus baseline scores between preferred and non-preferred arms was calculated . RESULTS There was a strong relationship between change in score and effect size ( P = 0.001 ; R(2 ) = 0.98 ) . Values for small , moderate , and large effects were -5.5 , -11.3 , and -18.2 mm . The participant preference change in score was -9 mm ( 95 % CI , -15.8 , -2.1 ) ( P = 0.008 ) . CONCLUSION This larger data set supports a clinical ly important difference of 10 mm . Studies should be powered to detect this difference CONTEXT Breathlessness is a distressing symptom in advanced disease . Underst and ing its patterns , burden , and palliative care ( PC ) needs over time is important to improve patients ' quality of life . OBJECTIVES To describe and compare the courses of refractory breathlessness , functional status , distress , and PC needs in patients with advanced chronic obstructive pulmonary disease ( COPD ) or lung cancer ( LC ) over time . METHODS This was a cohort study of patients with COPD ( Stage III/IV ) or LC . Data were assessed monthly with up to 12 telephone interviews , using the modified Borg Scale , Karnofsky Performance Status Scale , Distress Thermometer  , and  Palliative care Outcome Scale  as outcomes measures . Descriptive analysis compared all outcomes between COPD and LC at baseline and over time ( forward from study entry and backward from death ) . RESULTS A total of 82 patients ( 50 COPD and 32 LC ) , mean ( SD ) age of 67.2 ( 7.8 ) , and 36 % female were included ( 8 COPD and 23 LC deceased ) . The patients with COPD perceived higher levels of breathlessness and distress at lower functional status steadily over time . The LC patients ' breathlessness , distress , and PC needs increased , whereas functional status decreased toward death . The PC needs were similar between disease groups . Breathlessness was negatively correlated with functional status ( COPD = mean r=-0.20 , P=0.012 ; LC = mean r=-0.277 , P=0.029 ) and positively correlated with PC needs in COPD patients ( mean r=0.343 , P<0.001 ) . Death was significantly predicted by diagnosis ( LC : hazard ratio=7.84 , P<0.001 ) and functional status ( 10 % decline : hazard ratio=1.52 , P=0.001 ) . CONCLUSION The PC needs of patients with advanced COPD are comparable with LC patients , and breathlessness severity and distress are even higher . The care for COPD patients requires further improvement to address symptom burden and PC needs 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 r and omised controlled trial . Methods A single-blinded fast-track pragmatic r and omised controlled trial was conducted for patients with chronic obstructive pulmonary disease referred to the service . Patients were r and omised 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 st and ard care . Outcomes examined included : response rates to the trial ; response rates to the individual question naires and items ; comments relating to the trial functioning made during interviews with patients , carers , referrers and service providers ; and , research er 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 r and omised 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 r and omisation 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 design ing blinded-trial protocol s . Trial registration Clinical Trials.gov BACKGROUND Breathlessness remains a refractory symptom in malignant lung disease .  Breathing training is an effective , non-pharmacological intervention but it is unclear how this should be delivered . This feasibility study aim ed to assess recruitment and retention , best end point and variability of breathlessness scores in order to calculate sample size for a future study . METHOD This was a single centre , r and omised controlled non-blinded parallel group feasibility study . Eligible participants ( breathless patients with intrathoracic malignancy ) received three breathlessness management training sessions or a single session only . Follow-up was for eight weeks and endpoints were : numerical rating scales ( NRS ) of breathlessness severity ; breathlessness distress ; HADS question naire ; coping ( BriefCOPE and our NRS coping question ) ; EQ-5D and EQ-VAS .  RESULTS 22 patients were r and omised over 12 months ; 55 % of expected recruitment from pilot data . Screening logs indicated this result ed , in part , from excluding patients who were receiving or who had recently received chemotherapy or radiotherapy . There was 40 % drop-out by week four . The most useful NRS scores for breathlessness severity were for " worst " and " average " over past 24h . From the variability data for " worst breathlessness " , a sample size of 270 should allow detection of a 30 % improvement in area under the curve in the three-session group compared with single-session , ( 90 % power ; p=0.05 , two-tailed ; 2:1 r and omisation single : three sessions ) allowing 50 % drop out at four weeks . CONCLUSIONS The follow-on study will test the hypothesis that three sessions of training improve breathlessness better than a single session . It will include patients undergoing palliative anti-cancer therapy . Stratification by centre will allow for differences in rates of chemotherapy or radiotherapy and variations in breathlessness service configuration Purpose To report the experience of using the SEIQoL-DW for the measurement of quality of life with patients with advanced COPD and consider its feasibility , acceptability and appropriateness for a Phase III r and omised controlled trial ( RCT ) . Methods The SEIQoL-DW was administered according to its instructions within a Phase II RCT 3–5 times per patient , across 13 patients and the process audio-recorded . Quantitative and qualitative criteria were used to assess feasibility , acceptability and appropriateness . Qualitative analysis of the transcripts and fieldwork notes was conducted using Framework Analysis . Results The SEIQoL-DW steps ( of identifying five quality of life cues , rating their functioning and importance ) were completed at 48/51 interviews . However , some respondents were overwhelmed by the scripted introduction , experienced difficulty with cue identification , and focused only on certain types of cues ( Step 1 ) ; some had difficulty interpreting and rating the concept of Step 2 ; and some had difficulty interpreting ‘ importance ’ and manipulating the SEIQoL-DW disc ( Step 3 ) . Conclusions Patients with advanced COPD were able to complete the SEIQoL-DW but analysis of its administration identified practical and conceptual concerns which question the validity of the results obtained . Suggestions for the development of the SEIQoL-DW and future feasibility studies are given BACKGROUND : A study was carried out to determine whether rating of dyspnoea by means of a visual analogue scale during a progressive exercise test is affected by the subject 's awareness of the progressive nature of the protocol . METHODS : Nineteen patients with chronic obstructive lung disease ( FEV1 mean ( SE ) 1.06 ( 0.07 ) 1 ) were studied . A preliminary incremental test was carried out with a work rate increasing by 10 watts every minute until the subject could no longer exercise , to determine the maximum work load ( Wmax ) and to anchor the upper end of the visual analogue scale . This was followed by two exercise tests performed one day apart in r and omised sequence , with two different protocol s. One was a 12 minute protocol that included two sudden bursts of three minute high intensity exercise , up to the subject 's Wmax , each preceded by three minutes of low level exercise . The other test was a conventional three minute incremental test lasting 12 minutes . On both study days the only information given to the subject about the temporal profile of load was that a change would be made every three minutes . The relation between dyspnoea , as assessed by the visual analogue scale , and ventilation , measured during high intensity or progressive exercise , was studied . RESULTS : The mean ( SE ) rates of increase of dyspnoea with increasing ventilation ( % of line length 1(-1 ) min ) obtained by linear regression analysis were similar for the two tests ( 2.86 ( 0.20 ) for progressive exercise and 2.87 ( 0.25 ) for high intensity exercise ) ; it was 2.59 ( 0.25 ) for the initial burst of high intensity exercise when the data on this were analysed separately . In six subjects with stable disease studied again two months later the reproducibility of the rating of dyspnoea was reasonably good for both protocol s. CONCLUSION : The results suggest that in most patients with chronic obstructive lung disease the assessment of exercise induced dyspnoea by means of a visual analogue scale during a progressive exercise test is not affected by the subject 's awareness of the progressive increase in work intensity
SUMMARY Despite a variety of measurement tools none can be recommended as gold st and ard for the assessment of dyspnoea .
A combination of unidimensional and multidimensional tools seems to be the best for clinical assessment .
PURPOSE OF REVIEW Refractory dyspnoea is a common and difficult to treat symptom in advanced disease .
Accurate assessment helps to guide treatment and prognosis .
RECENT FINDINGS The absence of commonly agreed assessment tools has been a significant barrier to improving care through inhibition of clinical research and limitation of clinicians ' ability to assess the effectiveness of their interventions .
Two recently published systematic review s on measurement tools for breathlessness identified a variety of tools but none could be recommended as gold st and ard .
For clinical purpose s , the combination of a unidimensional tool to assess dyspnoea severity and a multidimensional tool to evaluate the impact on a person 's quality of life seem most appropriate .
This review discusses the present evidence and puts forward a strategy for assessment and measurement of the symptom in clinical practice .