Clinically Important Differences in the Intensity of Chronic Refractory Breathlessness

Johnson, Miriam J.; Bland, John M.; Oxberry, Stephen G; Abernethy, Amy P.; Currow, David C.

doi:10.1016/j.jpainsymman.2013.01.011

Cited by 121 publications

(115 citation statements)

References 29 publications

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“…[21][22][23][24][25][26][27][28] In this study, those who respond have, on average, twice that reduction (19.8 mm) after a further week at the same dose. …”

Section: Discussionmentioning

confidence: 99%

The Longitudinal Pattern of Response When Morphine Is Used To Treat Chronic Refractory Dyspnea

Currow

Quinn

Greene

et al. 2013

Journal of Palliative Medicine

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Background: While evidence supports using sustained release morphine for chronic refractory breathlessness, little is known about the longitudinal pattern of breathlessness intensity as people achieve symptomatic benefit. The aim of this study is to describe this pattern.Methods: This secondary analysis used breathlessness intensity scores (100 mm visual analogue scale (VAS)) from a prospective, dose increment study of once daily (morning) sustained release morphine for chronic refractory breathlessness. Participants who achieved < 10% improvement over their own baseline at one week (10 mg) were titrated to 20 mg and if no response, another week later to 30 mg for one week. Time was standardized at the first day of the week in which participants responded generating twice daily data one week either side of symptomatic benefit. Analysis used random effect mixed modeling. Results: Of the 83 participants, 17/52 responders required > 10 mg: 13 participants (20 mg) and 4 (30 mg), contributing 634 VAS observations. In the week leading to a response, average VAS scores worsened by 0.3 mm/ day ( p = 0.16); the average improvement in the first 24 hours of response was 10.9 mm (7.0 to 14.7; p < 0.0001), with continued improvement of 2.2 mm/day ( p < 0.001) for six more days. Conclusion: When treating chronic refractory breathlessness with once daily sustained release morphine, titrate to effect, since inadequate dose may generate no response; and following an initial response, further dose increases should not occur for at least one week. Whether further benefit would be derived beyond day six on the dose to which people respond, and what net effect a further dose increase would have are questions yet to be answered.

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“…[21][22][23][24][25][26][27][28] In this study, those who respond have, on average, twice that reduction (19.8 mm) after a further week at the same dose. …”

Section: Discussionmentioning

confidence: 99%

The Longitudinal Pattern of Response When Morphine Is Used To Treat Chronic Refractory Dyspnea

Currow

Quinn

Greene

et al. 2013

Journal of Palliative Medicine

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“…Patients in the LTOT arm at 3 months reported an improvement in average breathlessness over the past 24 hours on the numerical rating score by a clinically important amount 57 (which was no longer apparent at 6 months). The improvement coincided with an improvement in the distress caused by breathlessness, reporting of having coped better with breathlessness, and a higher level of satisfaction with the treatment received for breathlessness.…”

Section: Quality Of Life Measuresmentioning

confidence: 98%

“…The minimum clinically important difference in the scale is 1 point. 56,57 How well a patient had coped with their breathlessness over the past 24 hours was anchored on 'not coping at all' and 'coping very well'. Satisfaction with treatment for breathlessness was anchored on 'not at all satisfied' and 'very satisfied'.…”

Section: Numerical Rating Scale For Breathlessnessmentioning

confidence: 99%

Does home oxygen therapy (HOT) in addition to standard care reduce disease severity and improve symptoms in people with chronic heart failure? A randomised trial of home oxygen therapy for patients with chronic heart failure

Clark

Johnson

Fairhurst

et al. 2015

Health Technol Assess

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BackgroundHome oxygen therapy (HOT) is commonly used for patients with severe chronic heart failure (CHF) who have intractable breathlessness. There is no trial evidence to support its use.ObjectivesTo detect whether or not there was a quality-of-life benefit from HOT given as long-term oxygen therapy (LTOT) for at least 15 hours per day in the home, including overnight hours, compared with best medical therapy (BMT) in patients with severely symptomatic CHF.DesignA pragmatic, two-arm, randomised controlled trial recruiting patients with severe CHF. It included a linked qualitative substudy to assess the views of patients using home oxygen, and a free-standing substudy to assess the haemodynamic effects of acute oxygen administration.SettingHeart failure outpatient clinics in hospital or the community, in a range of urban and rural settings.ParticipantsPatients had to have heart failure from any aetiology, New York Heart Association (NYHA) class III/IV symptoms, at least moderate left ventricular systolic dysfunction, and be receiving maximally tolerated medical management. Patients were excluded if they had had a cardiac resynchronisation therapy device implanted within the past 3 months, chronic obstructive pulmonary disease fulfilling the criteria for LTOT or malignant disease that would impair survival or were using a device or medication that would impede their ability to use LTOT.InterventionsPatients received BMT and were randomised (unblinded) to open-label LTOT, prescribed for 15 hours per day including overnight hours, or no oxygen therapy.Main outcome measuresThe primary end point was quality of life as measured by the Minnesota Living with Heart Failure (MLwHF) questionnaire score at 6 months. Secondary outcomes included assessing the effect of LTOT on patient symptoms and disease severity, and assessing its acceptability to patients and carers.ResultsBetween April 2012 and February 2014, 114 patients were randomised to receive either LTOT or BMT. The mean age was 72.3 years [standard deviation (SD) 11.3 years] and 70% were male. Ischaemic heart disease was the cause of heart failure in 84%; 95% were in NYHA class III; the mean left ventricular ejection fraction was 27.8%; and the median N-terminal pro-B-type natriuretic hormone was 2203 ng/l. The primary analysis used a covariance pattern mixed model which included patients only if they provided data for all baseline covariates adjusted for in the model and outcome data for at least one post-randomisation time point (n = 102: intervention,n = 51; control,n = 51). There was no difference in the MLwHF questionnaire score at 6 months between the two arms [at baseline the mean score was 54.0 (SD 18.4) for LTOT and 54.0 (SD 17.9) for BMT; at 6 months the mean score was 48.1 (SD 18.5) for LTOT and 49.0 (SD 20.2) for BMT; adjusted mean difference –0.10, 95% confidence interval (CI) –6.88 to 6.69;p = 0.98]. At 3 months, the adjusted mean MLwHF questionnaire score was lower in the LTOT group (–5.47, 95% CI –10.54 to –0.41;p = 0.03) and breathlessness scores improved, although the effect did not persist to 6 months. There was no effect of LTOT on any secondary measure. There was a greater number of deaths in the BMT arm (n = 12 vs.n = 6). Adherence was poor, with only 11% of patients reporting using the oxygen as prescribed.ConclusionsAlthough the study was significantly underpowered, HOT prescribed for 15 hours per day and subsequently used for a mean of 5.4 hours per day has no impact on quality of life as measured by the MLwHF questionnaire score at 6 months. Suggestions for future research include (1) a trial of patients with severe heart failure randomised to have emergency oxygen supply in the house, supplied by cylinders rather than an oxygen concentrator, powered to detect a reduction in admissions to hospital, and (2) a study of bed-bound patients with heart failure who are in the last few weeks of life, powered to detect changes in symptom severity.Trial registrationCurrent Controlled Trials ISRCTN60260702.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 75. See the NIHR Journals Library website for further project information.

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“…The MCID of a change of 1 point on the breathlessness scale found by Hui et al is remarkably similar to the findings of our secondary analysis of data from 4 clinical trials of opioids for refractory breathlessness. 6 Furthermore, because the MCID in Johnson et al was assessed by patient-anchored (blinded patient preference) and statistical distribution methods, we were able to determine that such a change would be both a moderate effect size and a difference that resulted in patient-led treatment choice. Our findings from the distribution method were remarkably similar to the estimate derived from Hui et al's standard-error-of-measurement sensitivity analysis 1 (an 11.3-mm moderate effect size for Johnson et al 6 vs a 1.2-point change for 0.5 standard deviations for Hui et al).…”

Section: 3mentioning

confidence: 99%

Minimal clinically important difference and Edmonton Symptom Assessment Scale

Johnson

Currow

2015

Cancer

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We appreciate the interest of Testino et al in our recent review. 1 We agree that the risk of hepatocellular carcinoma (HCC) remains elevated for patients who achieve a sustained virological response (SVR), particularly for those who already have cirrhosis. This is a particular group of patients who likely warrant continued regular screening for HCC. Indeed, a subgroup analysis of trials enrolling only hepatitis C virus (HCV) patients with advanced fibrosis and cirrhosis found a 3-fold-increased risk of HCC in patients who achieved SVR in comparison with trials enrolling patients at all stages of fibrosis.2 As we discuss in our review, a critical area of research will be identifying for continued screening and treatment those patients who attain SVR and continue to be at the highest risk for HCC.We also agree that type 2 diabetes mellitus and alcohol consumption are additional risk factors for HCC, particularly for those patients with preexisting cirrhosis. Emerging data suggest that in addition to serving as independent risk factors for the development of HCC, nonalcoholic steatohepatitis (a known result of type 2 diabetes mellitus) and alcoholic steatohepatitis act to increase the risk for HCC in HCV patients who have attained SVR. 2,3These findings support the developing model of multidisciplinary care for HCV patients, which will include hepatologists and other specialists who are able to assist in managing comorbid factors, including alcohol use, obesity, and diabetes, to maximize their prognosis. FUNDING SUPPORTNo specific funding was disclosed. CONFLICT OF INTEREST DISCLOSURESRaymond T. Chung reports grants from Gilead, Bristol-Myers Squibb, Merck, Janssen, and Biologics; grants and personal fees from AbbVie; and personal fees from Idenix outside the submitted work.

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Clinically Important Differences in the Intensity of Chronic Refractory Breathlessness

Abstract: This larger dataset supports a clinically important difference of 10mm. Studies should be powered to detect this difference.

Cited by 121 publications

References 29 publications

The Longitudinal Pattern of Response When Morphine Is Used To Treat Chronic Refractory Dyspnea

The Longitudinal Pattern of Response When Morphine Is Used To Treat Chronic Refractory Dyspnea

Does home oxygen therapy (HOT) in addition to standard care reduce disease severity and improve symptoms in people with chronic heart failure? A randomised trial of home oxygen therapy for patients with chronic heart failure

Minimal clinically important difference and Edmonton Symptom Assessment Scale

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