Periodic Reporting for period 4 - BETTER-B (BETTER TREATMENTS FOR BREATHLESSNESS IN PALLIATIVE AND END OF LIFE CARE)
Período documentado: 2023-07-01 hasta 2023-12-31
The BETTER-B project focuses on breathlessness that persists despite optimal treatment of the underlying disease, usually referred to as chronic or refractory. This type of breathlessness is burdensome, neglected and yet one of the most common symptoms of advanced disease, estimated to affect 15 million people in Europe. Breathlessness can have a devastating impact on patients’ lives, and that of their family, friends and caregivers. Further, chronic breathlessness results in high health, social and informal care costs. New treatments for breathlessness are urgently needed as there is currently no widely licensed drug for the management of chronic breathlessness. An existing antidepressant, mirtazapine, has the potential to decrease chronic or refractory breathlessness in patients with advanced respiratory disease, in palliative care and at end of life. However, currently there is not robust evidence for mirtazapine’s use for this purpose. The overall objective of the BETTER-B project was to test whether mirtazapine is an effective and cost-effective medicine for the relief of patient-reported chronic or refractory breathlessness in patients with chronic obstructive pulmonary disease (COPD) and interstitial lung diseases (ILD). Concurrently, the project mapped and compared views, usual practice and experiences of palliative and respiratory clinicians across Europe on the main medications to alleviate breathlessness in COPD and ILD. A European wide survey of respiratory and palliative care physicians to explore current management of chronic breathlessness, and to determine the influence of practice guidance on management was completed. The results highlighted the need for more drug treatment options for breathlessness. We have actively engaged with those affected by breathlessness across Europe to inform our plans and produce European wide accessible guidance on the pharmacological management of severe chronic breathlessness in adults with advanced life-limiting diseases. We have submitted our Practice Review for publication in the top specialty journal called Palliative Medicine.
We successfully completed the BETTER-B programme including a Europe-wide survey on physicians’ attitudes and experiences of managing breathlessness, an international randomised controlled trial on the clinical and cost-effectiveness of mirtazapine (a re-purposed medicine) for chronic breathlessness, development of the evidence-based European guidance, now being presented as a Practice Review in Palliative Medicine, as well as qualitative interviews to understand patients and caregivers’ experiences of the trial medication.
Our survey in WP1 revealed substantial variation in the approach to clinical management of chronic refractory breathlessness between specialties, and between lung diseases. Knowledge of clinical practice guidelines appeared to influence evidence-based treatment choices, but there was also evidence of deviation from current recommendations. People were receiving different levels of care based on where they were treated and the disease that they had. Some people may be seen by a respiratory specialist, while others may be treated by palliative care specialists. A substantial proportion of palliative care and respiratory medicine physicians were also using benzodiazepines for breathlessness despite the evidence that benzodiazepines failed to provide evidence of benefit and were associated with harm. Many respondents were unaware of relevant guidelines. Our results were shared at conferences and published open access online in BMC Pulmonary Medicine in Jan 2022. The WP1 survey pointed to the need to consider other treatment options for breathlessness, while also developing cross-specialty guidelines that are user-friendly and well-publicised that could potentially improve practice.
We responded to this need in the BETTER-B randomised, placebo-controlled trial of mirtazapine. We recruited a total of 300 participants (225 patients and 75 caregivers) in Europe, Australia and New Zealand. The trial was conducted in the eye of the storm of the COVID-19 pandemic. The pandemic and lockdowns posed unprecedented challenges to healthcare systems across Europe and in our participating countries, reshaping the landscape of patient care and clinical research. We now have the largest trial of mirtazapine for breathlessness in our patient population. We have also developed an evidence-based European guidance, now being presented as a Practice Review in Palliative Medicine to share best practice around the use of pharmacological treatment options for severe chronic breathlessness in adults with advanced life-limiting diseases.
U-MUEN with support from KCL, partners and the Ethics Advisory Board (EAB) have built an engaged network of patient, public and professional members. We have been guided by the EAB and our Patient and Public Involvement and Engagement (PPIE) members regarding how and in what form we share information on the project website. We developed and translated factsheets for patients, and their families, to explain what happens once a person goes into hospital with COVID-19, co-produced with our partners, the European Lung Foundation. We also developed a guide to support people who suffer from breathlessness. Through Twitter, the guide reached over 70,000 people from across the world.
Our survey in WP1 revealed substantial variation in the approach to clinical management of chronic refractory breathlessness between specialties, and between lung diseases. Knowledge of clinical practice guidelines appeared to influence evidence-based treatment choices, but there was also evidence of deviation from current recommendations. People were receiving different levels of care based on where they were treated and the disease that they had. Some people may be seen by a respiratory specialist, while others may be treated by palliative care specialists. A substantial proportion of palliative care and respiratory medicine physicians were also using benzodiazepines for breathlessness despite the evidence that benzodiazepines failed to provide evidence of benefit and were associated with harm. Many respondents were unaware of relevant guidelines. Our results were shared at conferences and published open access online in BMC Pulmonary Medicine in Jan 2022. The WP1 survey pointed to the need to consider other treatment options for breathlessness, while also developing cross-specialty guidelines that are user-friendly and well-publicised that could potentially improve practice.
We responded to this need in the BETTER-B randomised, placebo-controlled trial of mirtazapine. We recruited a total of 300 participants (225 patients and 75 caregivers) in Europe, Australia and New Zealand. The trial was conducted in the eye of the storm of the COVID-19 pandemic. The pandemic and lockdowns posed unprecedented challenges to healthcare systems across Europe and in our participating countries, reshaping the landscape of patient care and clinical research. We now have the largest trial of mirtazapine for breathlessness in our patient population. We have also developed an evidence-based European guidance, now being presented as a Practice Review in Palliative Medicine to share best practice around the use of pharmacological treatment options for severe chronic breathlessness in adults with advanced life-limiting diseases.
U-MUEN with support from KCL, partners and the Ethics Advisory Board (EAB) have built an engaged network of patient, public and professional members. We have been guided by the EAB and our Patient and Public Involvement and Engagement (PPIE) members regarding how and in what form we share information on the project website. We developed and translated factsheets for patients, and their families, to explain what happens once a person goes into hospital with COVID-19, co-produced with our partners, the European Lung Foundation. We also developed a guide to support people who suffer from breathlessness. Through Twitter, the guide reached over 70,000 people from across the world.
Overall, the findings from the BETTER-B programme are likely to lead to significant opportunities for improving patient outcomes, advancing medical knowledge, and enhancing public health efforts.
As we noted, research into severe breathlessness in serious respiratory diseases is often neglected, for example compared to pain research. The findings from BETTER-B are contributing in several ways to reduce this inequity and improve the lives for people across Europe and to improve clinical care:
• Improved patient and informal carer support and quality of life: Developing and testing better treatments and management strategies for the 75 million across Europe affected by severe breathlessness and serious respiratory diseases. This can ultimately improve their quality of life and prognosis.
• Raising the profile of this neglected field and demonstrating that research is possible. BETTER-B has raised the profile of common respiratory diseases, including COPD and ILD to help funders and others understand the importance of this condition, and the opportunities for research.
• Understanding how to conduct international research of a major problem of this kind with full ethical integration and ensuring equipoise
• Development of novel therapies: Investigating breathlessness in respiratory disease can lead to the development of new therapeutic approaches aimed at alleviating symptoms and improving quality of life in individuals affected by breathlessness, not only with respiratory disease, but also potentially other causes such as heart disease. BETTER-B has taken a holistic approach, and although its main trial considered one pharmacological intervention, BETTER-B has considered pharmacological and non-pharmacological interventions, pulmonary rehabilitation programs and breathlessness support services.
• Individualised care and treatment approaches: By understanding and developing evidence, working with patient and public involvement partners, and developing guidance, BETTER-B findings will enable clinicians to develop more individualised care and treatment approaches.
As we noted, research into severe breathlessness in serious respiratory diseases is often neglected, for example compared to pain research. The findings from BETTER-B are contributing in several ways to reduce this inequity and improve the lives for people across Europe and to improve clinical care:
• Improved patient and informal carer support and quality of life: Developing and testing better treatments and management strategies for the 75 million across Europe affected by severe breathlessness and serious respiratory diseases. This can ultimately improve their quality of life and prognosis.
• Raising the profile of this neglected field and demonstrating that research is possible. BETTER-B has raised the profile of common respiratory diseases, including COPD and ILD to help funders and others understand the importance of this condition, and the opportunities for research.
• Understanding how to conduct international research of a major problem of this kind with full ethical integration and ensuring equipoise
• Development of novel therapies: Investigating breathlessness in respiratory disease can lead to the development of new therapeutic approaches aimed at alleviating symptoms and improving quality of life in individuals affected by breathlessness, not only with respiratory disease, but also potentially other causes such as heart disease. BETTER-B has taken a holistic approach, and although its main trial considered one pharmacological intervention, BETTER-B has considered pharmacological and non-pharmacological interventions, pulmonary rehabilitation programs and breathlessness support services.
• Individualised care and treatment approaches: By understanding and developing evidence, working with patient and public involvement partners, and developing guidance, BETTER-B findings will enable clinicians to develop more individualised care and treatment approaches.