Exploring the complexity of cystic fibrosis (CF) and psychosocial wellbeing in the 2020s: Current and future challenges.

Cystic fibrosis (CF) is traditionally associated with considerable and progressive multisystem pathology, onerous treatment burden, complex psychosocial challenges, and reduced life-expectancy [1-9].This decade has seen transformative change in management for many, but not all, people with CF. The most notable change comes from Cystic Fibrosis Transmembrane Receptor (CFTR) modulators, which bring significant benefits for people who are eligible for, and able to access, them [10]. However alongside, or perhaps because of, this exciting progress, the past few years have also brought important novel challenges to the psychosocial wellbeing of people with CF. This article, written as a collaboration between CF psychologists, social workers, physicians and nurses aims to provide an accessible overview of the novel psychosocial challenges now faced by children, their families, and adults with CF, and to invite consideration of their changing psychosocial requirements to inform future holistic care. Themes include geopolitical stressors such as the pandemic and its wake, a growing divide between those able or unable to access CFTR modulators, potential rapid changes in life expectancy secondary to these drugs and the inevitable associated challenges this brings; evolving body image, mental health side effects of CFTR modulators, the challenges of adherence in apparently well children and young adults, as well as the diagnostic conundrum and associated anxiety of the cystic fibrosis screen positive inconclusive diagnosis (CFSPID) label. It also highlights some unmet research and service delivery needs in the area.

Rapid nursing redeployment from a specialist ward to a COVID-19 high-dependency setting.

BACKGROUND: Redeployment in health care can have a negative impact on the mental wellbeing of staff. Advanced planning and provisions for wellbeing support for health professionals has been recommended following previous pandemics. At the authors' institution nurses were redeployed overnight from a specialist cystic fibrosis ward to a COVID-19 high-dependency unit. AIM: To evaluate nurses' wellbeing following this redeployment during the first wave of the COVID-19 pandemic. METHOD: A mixed online survey, consisting of both open and closed questions, based on literature, preliminary results of the Impact of COVID-19 on the Nursing and Midwifery Workforce (ICON) study and staff feedback. This was sent to 28 nurses to explore their feelings and experiences of redeployment to a COVID-19 environment. Purposive sampling was used to select study participants while thematic analysis and descriptive statistics were used to analyse the data. FINDINGS: The survey had an 86% response rate. Using thematic analysis three key themes emerged: redeployment anxiety, lack of organisational preparedness and newfound teamworking. More than half (57%) of respondents expressed anxiety and concern when told of their redeployment; 52% reported that they did not receive adequate support from senior staff and management. However, 74% reported that they felt their nursing was positively influenced by support and teamwork from those in patient-facing roles. Twenty-five percent reported that they were looking for a new job or leaving their current role. CONCLUSION: This study examines the effects that redeployment to a COVID-19 environment has had on nurses. It highlights the need for further improvement to ensure redeployed staff are supported to safeguard their mental wellbeing.

"Fortunate are those who take the first steps"? The psychosocial impact of novel drug development.

Novel drug development offers people with cystic fibrosis exciting opportunities but is not without challenges. Currently, there is an understandable emphasis on protecting patients' physical health when developing treatments. However, there appears to be little consideration of how novel drug development impacts on psychosocial wellbeing, or the downstream consequences of this. Using an illustrative case and reviewing the literature we explore themes regarding the psychosocial impact of trial participation and novel drug development and identify areas requiring further research. Through this, we hope to prepare healthcare professionals to better understand the needs of their patients in this rapidly evolving landscape.

Patient-reported outcomes in patients with cystic fibrosis with a G551D mutation on ivacaftor treatment: results from a cross-sectional study.

BACKGROUND: Clinical studies demonstrate that ivacaftor (IVA) improves health-related quality of life (HRQoL) in patients aged ≥6 years with cystic fibrosis (CF). The real-world impact of IVA and standard of care (SOC) in groups of patients with G551D and F508del mutations, respectively, was assessed using a survey comprising disease-specific and generic HRQoL measures. METHODS: Patients with CF aged ≥12 years, or aged 6-11 years with caregiver support, with either (1) a G551D mutation and receiving IVA (G551D/IVA) for ≥3 months, or (2) homozygous for F508del and receiving SOC before lumacaftor/IVA availability (F508del/SOC), were eligible to participate in a cross-sectional survey. Demographic and clinical characteristics, and HRQoL measures were compared between patient groups, and multiple regression analyses were conducted. RESULTS: After differences in patient demographic and clinical characteristics were controlled for, significantly better scores were observed in the G551D/IVA group than in the F508del/SOC group on multiple domains of the validated Cystic Fibrosis Questionnaire-Revised and the EuroQol 5-dimensions 5-level questionnaire. CONCLUSIONS: G551D/IVA patients reported better HRQoL than F508del/SOC patients on generic and disease-specific measures in a real-world setting.

Report of the European Respiratory Society/European Cystic Fibrosis Society task force on the care of adults with cystic fibrosis.

The improved survival in people with cystic fibrosis has led to an increasing number of patients reaching adulthood. This trend is likely to be maintained over the next decades, suggesting a need to increase the number of centres with expertise in the management of adult patients with cystic fibrosis. These centres should be capable of delivering multidisciplinary care addressing the complexity of the disease, in addition to addressing the psychological burden on patients and their families. Further issues that require attention are organ transplantation and end of life management.Lung disease in adults with cystic fibrosis drives most of the clinical care requirements, and major life-threatening complications, such as respiratory infection, respiratory failure, pneumothorax and haemoptysis, and the management of lung transplantation require expertise from trained respiratory physicians. The taskforce therefore strongly reccommends that medical leadership in multidisciplinary adult teams should be attributed to a respiratory physician adequately trained in cystic fibrosis management.The task force suggests the implementation of a core curriculum for trainees in adult respiratory medicine and the selection and accreditation of training centres that deliver postgraduate training to the standards of the HERMES programme.

How a patient perspective improved IV therapy.

Cystic fibrosis (CF) treatment is demanding and includes courses of intravenous antibiotics (IVAB), for which many patients are admitted to hospital. Our 35-bed adult respiratory ward delivers antibiotic doses up to four times a day but time pressures meant most patients did not receive their antibiotics on time. Many adults with CF are expert patients and plan their care with the healthcare team so a patient-nurse partnership was set up to resolve this issue. This article outlines a radical service change, based on a patient's comments, that was piloted and received positive feedback.

A discrete choice experiment to quantify the influence of trial features on the decision to participate in cystic fibrosis trials.

BACKGROUND: Patient-centred trial design optimises recruitment and retention, reduces trial failure rates and increases the diversity of trial cohorts. This allows safe and effective treatments to reach clinic more quickly. To achieve this, patients' views must be incorporated into trial design. METHODS: A discrete choice experiment was used to quantify preferences of pwCF for trials features; medicine type, trial location, stipend, washout, drug access on trial completion and trial design. Respondents were presented pairs of hypothetical trial scenarios with different level combinations assigned through experimental design. Respondents were asked to pick their preferred option or decline both. The cross-sectional data were explored using a Random Parameters Logit model. RESULTS: We received 207 eligible responses between Oct2020-Jan2021. The strongest influence on the decision to participate was trial location; pwCF favour participation at their usual clinical centre. Greater travel distances made respondents less willing to participate. Post-trial drug access ranked second. pwCF would rather participate in modulator trials than trials of other drugs. In general, pwCF did not favour a washout period, but were more prepared to washout non-modulators than modulators. Stipend provision was not ranked highly, but higher stipends increased intention to participate. Trial design (placebo vs open-label) had minimal influence on the decision to participate. There are complex interactions between placebos and washouts. CONCLUSIONS: We used quantitative methods to systematically elicit preferences of pwCF for clinical trials' features. We explore the relevance of our findings to trial design and delivery in the current CF trials landscape.

How representative are clinical trial cohorts of the general CF population? Implications for trial planning.

Understanding the number of patients eligible to participate in research is important to design protocols and define research priorities. We reviewed the records of all patients with CF, age 12+, who receive care at our centre. We assessed their eligibility for trial participation based on common trial inclusion/exclusion criteria. 643 patients were included in the analysis, 31 were modulator ineligible(MI). Only 198(31 %) of the total cohort and 7(23 %) of the MI cohort were eligible for participation based on the hypothetical criteria. The most common reason for ineligibility was ppFEV1 ≥90 % followed by clinical instability, complex comorbidity and anticipated inability to adhere to the protocol. We suggest this would be a useful exercise for centres planning to either participate in, or refer subjects into, upcoming trials to undertake for their own cohort. We also make suggestions for protocol designs that optimise the number of patients who are eligible to participate.

Standards of care and educational gaps in adult cystic fibrosis units: a European Respiratory Society survey.

Background: Significant progress in the field of cystic fibrosis (CF) has substantially extended the life expectancy of patients with CF (pwCF). Consequently, the population of adult pwCF has outnumbered paediatric patients in most developed countries. Ageing is a new factor that can contribute to disease complexity and can require adaptation of CF units. Therefore, the necessity for standardised, specialised and multidisciplinary care is imperative. Concerns arise regarding the adequacy of current healthcare, therapeutic and educational offerings. Methods: To address these concerns, a multinational survey was conducted to assess the current state of care in specialised multidisciplinary adult and paediatric CF units and identify areas for improvement. Responses were collected from 44 centres providing regular care to CF patients. Results: The survey unveiled considerable disparities in the availability of critical resources, including diagnostic access, supplementary testing, treatment modalities, transplant and transition programmes, and healthcare professionals' training. Conclusion: This study underscores the urgent need to standardise care across these centres in order to minimise disparities in terms of available resources and training with a particular emphasis on adult pwCF who are becoming more numerous and showing different needs with ageing. The changing landscape of CF in adulthood will require constant monitoring to ensure proper adaptation of the current model of care.

A systematic review to identify and collate factors influencing patient journeys through clinical trials.

Patient-centred trial design and delivery; improves recruitment and retention; increases participant satisfaction; encourages participation by a more representative cohort; and allows researchers to better meet participants' needs. Research in this area mostly focusses on narrow facets of trial participation. We aimed to systematically identify the breadth of patient-centred factors influencing participation and engagement in trials, and collate them into a framework. Through this we hoped to assist researchers to identify factors that could improve patient-centred trial design and delivery. Robust qualitative and mixed methods systematic reviews are becoming increasingly common in health research. The protocol for this review was prospectively registered on PROSPERO, CRD42020184886. We used the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research Type) framework as a standardised systematic search strategy tool. 3 databases were searched as well as references checking, and thematic synthesis was conducted. Screening agreement was performed and code and theme checking were conducted by 2 independent researchers. Data were drawn from 285 peer-reviewed articles. 300 discrete factors were identified, and sorted into 13 themes and subthemes. The full catalogue of factors is included in the Supplementary Material. A summary framework is included in the body of the article. This paper focusses on outlining common ground that themes share, highlighting critical features, and exploring interesting points from the data. Through this, we hope researchers from multiple specialities may be better able to meet patients' needs, protect patients' psychosocial wellbeing, and optimise trial recruitment and retention, with direct positive impact on research time and cost efficiency.

SARS-CoV-2 driving rapid change in adult cystic fibrosis services: the role of the clinical nurse specialist.

Cystic fibrosis (CF) is a genetic, life-limiting disease without a cure; treatment is complex and lifelong. Respiratory failure is the most common cause of death; however, gastrointestinal disease, diabetes and liver disease are common comorbidities. Coronavirus disease (COVID-19) rapidly changed healthcare services across the globe, including redeployment of healthcare professionals. This adult CF service was challenged to continue a patient facing service within severe staffing and structural limitations.Not only were many members of the CF multidisciplinary team (MDT) redeployed at the start of the first wave, but also both the CF and ambulatory care wards were closed. Fortunately, the CF clinical nurse specialists (CF-CNSs) remained in their role. Rapid change and adaptation of the CF service was required to ensure that patients did not feel abandoned and access to treatment remained available. The role of the CF-CNS was therefore pivotal in this change.The aim of this project was to use quality improvement methodology to plan an emergency service allowing a reintroduction of ambulatory care services. Success was measured by the number of patients clinically reviewed with or without intervention, and the reasons for patients contacting the CF-CNS via email and phone were recorded.In weeks 1 and 2 of the emergency service, the CF-CNSs triaged patients by phone, then reviewed face-to-face when necessary. This first step allowed the CF-CNSs to start two patients on home intravenous antibiotics. This service continued to be developed over the following 12 weeks, leading to a total of 36 patient attendances. In March 2020, n=1187 patients made contact (mostly COVID-19, unwell and medication related), in April n=904 and May n=870 (blood test results, unwell and medication related).The motivation of the CF-CNSs was pivotal to the success of this initiative with the CF MDT available to provide some support and advice. It concluded at week 12, which then saw the opening of the formal ambulatory care ward and returning redeployed ward staff.

Discrete choice experiment (DCE) to quantify the influence of trial features on the decision to participate in cystic fibrosis (CF) clinical trials.

INTRODUCTION: Engaging people with cystic fibrosis (CF) in clinical trials is critical to improving outcomes for this fatal disease. Following extensive exploration of engagement in CF trials we believe six key concepts require a quantitative understanding of their influence in the current CF trials landscape including how controversial issues like placebos, washouts, stipend provision and location of trial visits are viewed by the CF community and how these might be modified depending on the type of medicine being investigated and the mechanism of access to the drug on trial completion. METHODS AND ANALYSIS: We have designed and will administer an online discrete choice experiment to elicit and quantify preferences of people with CF for these trials' attributes and estimate the relative importance of an attribute when choosing to participate in a trial. The cross-sectional data generated will be explored using conditional multinomial logit model. Mixed logit models such as the random-parameters logit and a latent class models will be used to explore preference heterogeneity. To determine the relative importance of an attribute, the difference between the attribute level with the highest preference weight and the level with the lowest preference weight will be calculated. ETHICS AND DISSEMINATION: Imperial College London Joint Research Compliance Office has granted ethical approval for this study. Patient consent will be sought following full explanation. No identifying information will be collected. Dissemination will be via international conferences, peer-review publication and patient accessible forums. Major CF trials networks have agreed to incorporate our findings into their review process, meaning our results can realistically influence and optimise CF trial delivery. PROSPERO REGISTRATION NUMBER: CRD42020184886.

Learning to breathe with Tai Chi online - qualitative data from a randomized controlled feasibility study of patients with cystic fibrosis.

INTRODUCTION: Tai Chi (TC), a gentle exercise, incorporates meditative movement and respiratory control. The high risk of cross infection for people with cystic fibrosis (CF) requires close management in healthcare settings, limiting group activities such as TC. A mixed-methods randomized controlled feasibility study compared teaching TC over the internet with in-person, face to face TC tuition provided to CF patients. This article explores qualitative data from patients and TC instructors on their attitudes, acceptability and engagement with the two modes of TC delivery. METHODS: Qualitative data from CF patients (>6 years) were collected using Skype interviews/focus groups and written feedback. TC instructors provided weekly written feedback, and took part in interviews/ focus groups at the end of the study. Patient and instructor interviews explored their experiences and engagement with TC online delivery and ability to practice. RESULTS: Irrespective of the type of TC delivery, all CF participants interviewed (n = 28) practiced between lessons and most wanted to continue TC. Teenagers were more likely to miss TC appointments. Internet delivery was well received by both patients and TC instructors. Two patients reported difficulties with screen size/camera and one with internet connectivity. CONCLUSION: Both face-to-face and internet delivery of TC lessons were equally well received and perceived as beneficial. In the current COVID-19 pandemic, CF patients self-isolating could find this intervention provides important support, therefore the programme was made available on YouTube in April 2020 and linked to the websites of the CF charities funding the research.

The future of cystic fibrosis care: a global perspective.

The past six decades have seen remarkable improvements in health outcomes for people with cystic fibrosis, which was once a fatal disease of infants and young children. However, although life expectancy for people with cystic fibrosis has increased substantially, the disease continues to limit survival and quality of life, and results in a large burden of care for people with cystic fibrosis and their families. Furthermore, epidemiological studies in the past two decades have shown that cystic fibrosis occurs and is more frequent than was previously thought in populations of non-European descent, and the disease is now recognised in many regions of the world. The Lancet Respiratory Medicine Commission on the future of cystic fibrosis care was established at a time of great change in the clinical care of people with the disease, with a growing population of adult patients, widespread genetic testing supporting the diagnosis of cystic fibrosis, and the development of therapies targeting defects in the cystic fibrosis transmembrane conductance regulator (CFTR), which are likely to affect the natural trajectory of the disease. The aim of the Commission was to bring to the attention of patients, health-care professionals, researchers, funders, service providers, and policy makers the various challenges associated with the changing landscape of cystic fibrosis care and the opportunities available for progress, providing a blueprint for the future of cystic fibrosis care. The discovery of the CFTR gene in the late 1980s triggered a surge of basic research that enhanced understanding of the pathophysiology and the genotype-phenotype relationships of this clinically variable disease. Until recently, available treatments could only control symptoms and restrict the complications of cystic fibrosis, but advances in CFTR modulator therapies to address the basic defect of cystic fibrosis have been remarkable and the field is evolving rapidly. However, CFTR modulators approved for use to date are highly expensive, which has prompted questions about the affordability of new treatments and served to emphasise the considerable gap in health outcomes for patients with cystic fibrosis between high-income countries, and low-income and middle-income countries (LMICs). Advances in clinical care have been multifaceted and include earlier diagnosis through the implementation of newborn screening programmes, formalised airway clearance therapy, and reduced malnutrition through the use of effective pancreatic enzyme replacement and a high-energy, high-protein diet. Centre-based care has become the norm in high-income countries, allowing patients to benefit from the skills of expert members of multidisciplinary teams. Pharmacological interventions to address respiratory manifestations now include drugs that target airway mucus and airway surface liquid hydration, and antimicrobial therapies such as antibiotic eradication treatment in early-stage infections and protocols for maintenance therapy of chronic infections. Despite the recent breakthrough with CFTR modulators for cystic fibrosis, the development of novel mucolytic, anti-inflammatory, and anti-infective therapies is likely to remain important, especially for patients with more advanced stages of lung disease. As the median age of patients with cystic fibrosis increases, with a rapid increase in the population of adults living with the disease, complications of cystic fibrosis are becoming increasingly common. Steps need to be taken to ensure that enough highly qualified professionals are present in cystic fibrosis centres to meet the needs of ageing patients, and new technologies need to be adopted to support communication between patients and health-care providers. In considering the future of cystic fibrosis care, the Commission focused on five key areas, which are discussed in this report: the changing epidemiology of cystic fibrosis (section 1); future challenges of clinical care and its delivery (section 2); the building of cystic fibrosis care globally (section 3); novel therapeutics (section 4); and patient engagement (section 5). In panel 1, we summarise key messages of the Commission. The challenges faced by all stakeholders in building and developing cystic fibrosis care globally are substantial, but many opportunities exist for improved care and health outcomes for patients in countries with established cystic fibrosis care programmes, and in LMICs where integrated multidisciplinary care is not available and resources are lacking at present. A concerted effort is needed to ensure that all patients with cystic fibrosis have access to high-quality health care in the future.

Children and Adults Tai Chi Study (CF-CATS2): a randomised controlled feasibility study comparing internet-delivered with face-to-face Tai Chi lessons in cystic fibrosis.

Virtual healthcare is fast entering medical practice. Research into the feasibility of using it to teach treatment regimens such as exercise has not been explored. Maintaining an exercise regime can be difficult in cystic fibrosis: group classes risk potential infection, yet motivation is hard to maintain when alone. Tai Chi is a low-impact exercise and involves gentle, demanding movements. This study aimed to assess the feasibility, safety and acceptability of learning Tai Chi via an internet-based approach and compared patient-reported outcomes. Children and adults with cystic fibrosis were recruited to a randomised, comparative effectiveness trial. Participants learnt eight Tai Chi movements; teaching was delivered in eight lessons over 3 months: delivered either via the internet or face-to-face. Assessments were at 3-monthly intervals over 9 months. Outcomes included health status, quality of life, sleep, mindfulness and instructor-led questions. 40 adults and children completed the eight sets of Tai Chi lessons. The median age was 22.8 years (range 6.1-51.5 years); 27 patients were female. The cohort comprised 26 adults (aged >16 years), six teenagers and eight children (aged <12 years). The groups were well matched. Feasibility and safety were demonstrated. Participants showed significant improvements in self-reported sleep, cough (both daytime and night-time), stomach ache and breathing. No differences in lung function, health status, quality of life, sleep or mindfulness was shown before or after completing the lessons. Tai Chi was safe and well tolerated; it was feasible to deliver individual lessons via the internet, reducing concerns regarding cross-infection, and appeared to improve self-reported symptoms.

Limitations to providing adult cystic fibrosis care in Europe: Results of a care centre survey.

BACKGROUND: There are a growing number of adults in Europe with a projected increase of 75% over the next decade. There is concern that provision of care will not be sufficient to meet needs. We aimed to establish the level of CF service throughout Europe. METHODS: An online survey designed by clinicians and patient representatives to explore level of service. RESULTS: Training opportunities for clinicians and resources (physical and manpower) to provide care to adults with CF are limited in Europe. Although specific adult CF care has been identified, teams continue to be supported by paediatric colleagues and many adults are still being admitted to paediatric wards. In some centres, service delivery, particularly infection control and access to some CF medication is insufficient and in many places poor personnel resources limits access to comprehensive multidisciplinary teams. CONCLUSIONS: This survey shows an urgent need for the development of resources for adult CF care, in both physical space and appropriately trained clinicians.

Cystic fibrosis-Children and adults Tai Chi study (CF CATS2): Can Tai Chi improve symptoms and quality of life for people with cystic fibrosis? Second phase study protocol.

BACKGROUND: Cystic fibrosis (CF) is a genetic disorder affecting respiratory and digestive systems. People with CF experience physical symptoms; cough, poor lung ventilation, recurrent infections, poor weight gain, diarrhoea, and malnutrition, as well as lower quality of life. Tai Chi, a Chinese form of meditative movement, may help with the symptoms of CF and help people with CF to exercise. However, there is very little research in this area. OBJECTIVE: To evaluate the feasibility of studying Tai Chi for CF and to compare the effectiveness of Tai Chi to standard care and face-to-face Tai Chi with online Tai Chi for people with CF. METHODS: This is a comparative effectiveness trial with 72 people with CF over 6 years old and a patient at the Royal Brompton Hospital, London, UK. Participants receive 8 Tai Chi sessions, then home practice with a DVD. Sessions are one-on-one for group A, online for group B. Group B is a no treatment standard care control (first 3 months). At baseline, 3, 6 and 9 months, questionnaires will be used to measure quality of life, mindfulness and sleep, and medical data health and respiratory function. At Tai Chi sessions and at 4 follow-up points, the Borg Scale and healthcare use data will be collected. At 9 months online focus groups will assess participants' experience, Tai Chi feasibility, perceived health impact, and study participation. Recruitment will use adverts in hospital clinics and website, and letter/phone for non-regularly attending patients. Block randomisation will use random number tables. The two groups will be compared for: weeks 1 to 12 (Tai Chi vs. standard care); before and after intervention (differences in delivery method); week 1 (of intervention) to month 9 (long-term impact). Qualitative data will use Framework analysis. DISCUSSION: We believe this is the first trial of Tai Chi for CF. Tai Chi may help with the physiological symptoms of CF and increase levels of exercise by providing a self-management technique and low stress activity. This study will provide data on the feasibility of a randomized controlled trial of Tai Chi for CF, including data for a sample size calculation and will inform future study design.

Meditative movement for respiratory function: a systematic review.

BACKGROUND: Meditative movement, such as tai chi, yoga, and qi gong, may benefit people with cystic fibrosis (CF), as a form of gentle exercise incorporating meditation, breathing, and relaxation. Respiratory function is the most common issue in CF. In this systematic review we synthesized the evidence on the effect of meditative movement on respiratory function in patients with CF. METHODS: We searched Chinese and English language databases with terms relating to tai chi/yoga/qi gong, and respiratory function/cough/dyspnea. Articles were screened and selected by 2 researchers. We included controlled studies published in English or Chinese after 1980, and extracted data using a specially designed spreadsheet. Two researchers independently evaluated study quality and reporting, using 3 standardized checklists. Meta-analysis was not possible due to heterogeneous methods. RESULTS: We found 1,649 papers, included 43 (30 in English, 13 in Chinese), 23 of which were randomized controlled trials, and 20 were non-randomized trials. No studies were concerned with CF. Eleven studies included patients with respiratory disorders, and 27 included healthy people. Very few studies were high quality. The main problems with the randomized controlled trials was the randomization and non-random and/or poorly reported sampling. The main problems with the non-randomized studies were poor reporting of samples and non-equivalent groups. Although no clinically important changes were found, meditative movement may improve FEV1 in healthy people, compared to no treatment/exercise (the intervention groups showed effect-size changes from 0.07 to 0.83), but meditative movement did not appear to affect FEV1/FVC in subjects with COPD. Key study limitations were: poor reporting of sampling or methods; inadequate sample size; non-randomized design; inadequate description of randomization; randomization by center; no blinding; lack of reporting of important aspects of meditative movement; and short-term follow-up. CONCLUSIONS: The available evidence does not support meditative movement for patients with CF, and there is very limited evidence for respiratory function in healthy populations. The available studies had heterogeneous populations and provided inadequate sampling information, so clinically relevant conclusions cannot be drawn. Well powered, randomized studies of meditative movement are needed.