Effect of ambulatory oxygen on quality of life for patients with fibrotic lung disease (AmbOx): a prospective, open-label, mixed-method, crossover randomised controlled trial.

BACKGROUND: In fibrotic interstitial lung diseases, exertional breathlessness is strongly linked to health-related quality of life (HRQOL). Breathlessness is often associated with oxygen desaturation, but few data about the use of ambulatory oxygen in patients with fibrotic interstitial lung disease are available. We aimed to assess the effects of ambulatory oxygen on HRQOL in patients with interstitial lung disease with isolated exertional hypoxia. METHODS: AmbOx was a prospective, open-label, mixed-method, crossover randomised controlled clinical trial done at three centres for interstitial lung disease in the UK. Eligible patients were aged 18 years or older, had fibrotic interstitial lung disease, were not hypoxic at rest but had a fall in transcutaneous arterial oxygen saturation to 88% or less on a screening visit 6-min walk test (6MWT), and had self-reported stable respiratory symptoms in the previous 2 weeks. Participants were randomly assigned (1:1) to either oxygen treatment or no oxygen treatment for 2 weeks, followed by crossover for another 2 weeks. Randomisation was by a computer-generated sequence of treatments randomly permuted in blocks of constant size (fixed size of ten). The primary outcome, which was assessed by intention to treat, was the change in total score on the King's Brief Interstitial Lung Disease questionnaire (K-BILD) after 2 weeks on oxygen compared with 2 weeks of no treatment. General linear models with treatment sequence as a fixed effect were used for analysis. Patient views were explored through semi-structured topic-guided interviews in a subgroup of participants. This study was registered with ClinicalTrials.gov, number NCT02286063, and is closed to new participants with all follow-up completed. FINDINGS: Between Sept 10, 2014, and Oct 5, 2016, 84 patients were randomly assigned, 41 randomised to ambulatory oxygen first and 43 to no oxygen. 76 participants completed the trial. Compared with no oxygen, ambulatory oxygen was associated with significant improvements in total K-BILD scores (mean 55·5 [SD 13·8] on oxygen vs 51·8 [13·6] on no oxygen, mean difference adjusted for order of treatment 3·7 [95% CI 1·8 to 5·6]; p<0·0001), and scores in breathlessness and activity (mean difference 8·6 [95% CI 4·7 to 12·5]; p<0·0001) and chest symptoms (7·6 [1·9 to 13·2]; p=0·009) subdomains. However, the effect on the psychological subdomain was not significant (2·4 [-0·6 to 5·5]; p=0·12). The most common adverse events were upper respiratory tract infections (three in the oxygen group and one in the no-treatment group). Five serious adverse events, including two deaths (one in each group) occurred, but none were considered to be related to treatment. INTERPRETATION: Ambulatory oxygen seemed to be associated with improved HRQOL in patients with interstitial lung disease with isolated exertional hypoxia and could be an effective intervention in this patient group, who have few therapeutic options. However, further studies are needed to confirm this finding. FUNDING: UK National Institute for Health Research.

Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial.

BACKGROUND: Fibrotic interstitial lung diseases (ILDs) are chronic and often progressive conditions resulting in substantial morbidity and mortality. Shortness of breath, a symptom often linked to oxygen desaturation on exertion, is tightly linked to worsening quality of life in these patients. Although ambulatory oxygen is used empirically in their treatment, there are no ILD-specific guidelines on its use. To our knowledge, no studies are available on the effects of ambulatory oxygen on day-to-day life in patients with ILD. METHODS/DESIGN: Ambulatory oxygen in fibrotic lung disease (AmbOx) is a multicentre, randomised controlled crossover trial (RCT) funded by the Research for Patient Benefit Programme of the National Institute for Health Research. The trial will compare ambulatory oxygen used during daily activities with no ambulatory oxygen in patients with fibrotic lung disease whose oxygen saturation (SaO2) is ≥94% at rest, but drops to ≤88% on a 6-min Walk Test. The randomised controlled trial (RCT) will evaluate the effects on health status (measured by the King's Brief ILD Questionnaire: K-BILD) of ambulatory oxygen used at home, at an optimal flow rate determined by titration at screening visit, and administered for a 2-week period, compared to 2 weeks off oxygen. Key secondary outcomes will include breathlessness on activity scores, as measured by the University of California San Diego Shortness of Breath Questionnaire, global patient assessment of change scores, as well as quality of life scores (St George's Respiratory Questionnaire), anxiety and depression scores (Hospital Anxiety and Depression Scale), activity markers measured by SenseWear Armbands, pulse oximetry measurements, patient-reported daily activities, patient- and oxygen company-reported oxygen cylinder use. The study also includes a qualitative component and will explore in interviews patients' experiences of the use of a portable oxygen supply and trial participation in a subgroup of 20 patients and carers. DISCUSSION: This is the first RCT of the effects of ambulatory oxygen during daily life on health status and breathlessness in fibrotic lung disease. The results generated should provide the basis for setting up ILD-specific guidelines for the use of ambulatory oxygen. TRIAL REGISTRATION: National Clinical Trials Registry, identifier: NCT02286063 . Registered on 8 October 2014 (retrospectively registered).

Illness perception, self-care behaviour and quality of life of heart failure patients: a longitudinal questionnaire survey.

OBJECTIVES: To examine the associations between illness perception, self-care behaviour, and quality of life in patients admitted to hospital with a primary diagnosis of heart failure (HF), and the changes in these at 2 and 6 months after discharge. DESIGN: Longitudinal questionnaire-based study. SETTING: Three London hospitals with specialist heart failure services. PARTICIPANTS: A convenience sample of 88 patients (70% male, mean age 70) admitted to hospital with a primary diagnosis of heart failure were recruited prior to discharge. Participants were over the age of 18, able to understand English, and with the cognitive ability to complete the questionnaires. Thirty-eight patients did not provide follow-up data: 21 (24%) died during the 6-month follow-up period, and 17 (19%) did not return their post-discharge questionnaires. METHODS: The Revised Illness Perception Questionnaire, the Self-Care Heart Failure Index, Hospital Anxiety and Depression scale, and the Minnesota Living with Heart Failure (MLHF) Questionnaires were completed prior to discharge from hospital, and 2 and 6 months after discharge. RESULTS: HF symptoms improved over time (MLHF score co-efficient [95%CI] -0.915 [-1.581, -0.250], P<0.001). Patients appeared to believe that many of the causes of their illness were outside their control. Although self-care maintenance (e.g. weighing daily) improved over time, this did not translate into increased involvement in self-care management (e.g. adjusting diuretic dose) or the ability to act on changes in symptoms. Self-care confidence was lower in those who reported a more negative emotional impact of their illness, but was higher in those who had high scores on illness coherence. CONCLUSIONS: Six months following hospital discharge, patients' symptom control had improved. Many continued to believe that their illness was outside their control, and although self-care maintenance improved this was not associated with greater self-care management, particularly if the patient's emotional state was negative, and their understanding of their condition was poor. Our data suggest that a more participative person-centred approach, tailoring the disease management programme to address the patient's illness beliefs and emotional state, assisting the individual to identify barriers and solutions, may help increase self-care confidence and management.

Long-term outcomes of patients bridged to recovery versus patients bridged to transplantation.

OBJECTIVE: The proportion of patients who can be bridged with left ventricular assist devices to myocardial recovery and the long-term outcome of these patients is unknown. METHODS: We investigated the outcomes of patients bridged to recovery compared with those bridged to transplantation. All left ventricular assist devices were implanted as a bridge to transplantation with a very proactive program of promoting myocardial recovery. A total of 40 patients were bridged to recovery and 52 to transplantation. Of the bridged to recovery (explanted) group, 33 were men (age, 32.8 ± 11.8 years), 37 had dilated cardiomyopathy (familial in 3, peripartum cardiomyopathy in 3) and 3 had myocarditis. Of the bridged to transplantation (transplanted) group, 42 were men (age, 42.3 ± 12.5 years; P < .0005 vs bridged to recovery). The diagnosis was ischemic heart disease in 24, dilated cardiomyopathy in 21 (only 13 received drug therapy), hypertrophic obstructive cardiomyopathy in 2, arrythmogenic right ventricular dysplasia in 2, myocarditis in 1, and congestive heart disease in 2. RESULTS: The survival rate was 89.9%, 73.9%, and 73.9% and 80.4%, 78.3, and 78.3% in the explanted and transplanted groups at 1, 5, and 7 years, respectively. In total, 12 (23%) patients bridged transplantation either died from, or required ventricular assist device support, for primary graft failure. Of the explanted patients, 4 (10%) subsequently required transplantation at 34, 512, 1019, and 1213 days (2 died 25 and 1867 days after transplantation and 2 were well after 1523 and 3199 days). The rate of transplant or ventricular assist device-free survival less noncardiac death for the bridged to recovery and bridged to transplantation groups, respectively, was 89.9%, 73.9%, and 73.9% and 80.4%, 78.3%, and 78.3% at 1, 3, and 7 years. At latest follow-up (1394 ± 1195 days for the bridged to recovery and 1913 ± 941 days for the bridged to transplantation group), 5 of the bridged to transplantation patients (9.6%) had malignancy, 34 (65.4%) had hypercholesterolemia, 25 (48.1%) had hypertension, and 7 (13.5%) had coronary disease. The creatinine was 125.5 ± 43.5 vs 95.2 ± 16.5 µmol/L for the bridged to transplantation and bridged to recovery groups (P < .001). CONCLUSIONS: The outcome after explantation for myocardial recovery is comparable, if not better than, after bridge to transplantation.

The relationship between nurse staffing and patient outcomes: a case study.

BACKGROUND: Research has shown a direct relationship between staffing levels and patient outcomes for specific nurse-sensitive indicators, with lower patient to nurse ratios (i.e. less patients per nurse) associated with better outcomes. OBJECTIVES: To explore the relationship between nurse staffing characteristics (the nursing hours worked by permanent and temporary staff and nurse hours per patient day) and patient outcomes: pressure sores, patient falls, upper gastrointestinal bleed, pneumonia, sepsis, shock and deep vein thrombosis. DESIGN: A case study using retrospective hospital data, at ward level. SETTING: A tertiary cardio-respiratory NHS Trust in England, comprising two hospitals. PARTICIPANTS: All patients, including day cases, who were admitted to either hospital as an in-patient over 12 months. METHODS: Data were extracted from corporate hospital systems. The clinical areas were categorised as lower dependency, i.e. wards, or critical care which included ICU and high dependency units. The relationship between nurse staffing characteristics and patient outcomes was assessed using either a Poisson or negative binomial regression model as appropriate. We sought to establish whether the outcomes were affected by the nurse hours per patient day, the permanent nurse hours worked as a percentage of the total hours, and the permanent nurse hours worked as a percentage of the permanent and bank hours combined. RESULTS: In the lower dependency category wards there was only a weak association demonstrated between nurse staffing and the majority of the outcomes. The results from the high dependency critical care areas showed few significant results with only the rate of sepsis being significantly reduced as the ratio of permanent staff hours increased. CONCLUSIONS: The study demonstrated the possibility of using existing hospital data to examine the relationship between nurse staffing and patient outcomes, however the associations found were weak and did not replicate reliably the findings from previous work.