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).

Use of an abridged scored Patient-Generated Subjective Global Assessment (abPG-SGA) as a nutritional screening tool for cancer patients in an outpatient setting.

The scored Patient-Generated Subjective Global Assessment tool (PG-SGA), regarded as the most appropriate means of identifying malnutrition in cancer patients, is often challenging to implement in a busy outpatient setting. We assessed the validity of an abridged version of the PG-SGA (abPG-SGA), which forgoes the physical examination, and compared its usefulness in discerning malnutrition to the full PG-SGA and Malnutrition Screening Tool (MST). The nutritional status of 90 oncology outpatients receiving chemotherapy was assessed according to SGA global rating, PG-SGA, and MST. Receiver operating characteristic (ROC) curves were generated to estimate the sensitivity and specificity of various cut-off scores for malnutrition. Thirty-six percent of patients were malnourished (SGA). The abPG-SGA yielded 94% sensitivity and 78% specificity and area under the curve (AUC) = 0.956, which was slightly lower than PG-SGA (97% sensitivity, 86% specificity, AUC = 0.967) and higher than MST (81% sensitivity, 72% specificity, AUC = 0.823). Patient reported symptoms included loss of appetite (30%), altered taste (31%), fatigue (30%), and decreased ability to perform activities of daily living (53%). In conclusion, the abPG-SGA is a practical, informative and valid tool for detecting malnutrition in the outpatient oncology setting.