No gender-related bias in COPD diagnosis and treatment in Sweden: a randomised, controlled, case-based trial.

INTRODUCTION: COPD is a major cause of morbidity and mortality. The prevalence, morbidity and mortality of COPD among females have increased. Previous studies indicate a possible gender bias in the diagnosis and management of COPD. The present study aims to determine if there is gender bias in the management of COPD in Sweden. METHODS: This was a double-blind, randomised (1:1), controlled, parallel-group, web-based trial using the hypothetical case scenario of a former smoker (40 pack-years and quit smoking 3 years ago) who was male or female. The participants were blind to the randomisation and the purpose of the trial. The case progressively revealed more information with associated questions on how the physician would manage the patient. Study participants chose from a list of tests and treatments at each step of the case scenario. RESULTS: In total, 134 physicians were randomised to a male (n=62) or a female (n=72) case. There was no difference in initial diagnosis (61 (98%) male cases and 70 (97%) female cases diagnosed with COPD) and planned diagnostic procedures between the male and female cases. Spirometry was chosen by all the physicians as one of the requested diagnostic tests. The management of the hypothetical COPD case did not differ by sex of the responding physician. CONCLUSION: In Sweden, diagnosis and management of a hypothetical patient with COPD did not differ by the gender of the patient or physician.

Extended-Release Morphine for Chronic Breathlessness in Pulmonary Arterial Hypertension-A Randomized, Double-Blind, Placebo-Controlled, Crossover Study.

CONTEXT: Pulmonary arterial hypertension (PAH) affects people of all ages and is associated with poor prognosis. Chronic breathlessness affects almost all people with PAH. OBJECTIVES: This randomized, placebo-controlled, double-blind, crossover study aimed to evaluate the effects of regular, low-dose, extended-release (ER) morphine for PAH-associated chronic breathlessness. METHODS: Participants with PAH-associated chronic breathlessness were randomized to 1) seven days of ER morphine 20 mg, 2) seven-day washout, and 3) seven days of identically looking placebo, or vice versa. Primary end points were breathlessness "right now"-morning and evening-measured with a Visual Analogue Scale. Secondary end points included additional breathlessness measures, quality of life, function, harms, and blinded treatment preference (ACTRN12609000209291). RESULTS: Within a period of seven years, 50 patients were assessed in detail and 23 (46%) were randomized (despite broad eligibility criteria). Four participants withdrew while taking morphine. Nineteen participants completed the study. Breathlessness "right now" was higher on morphine compared with placebo both for morning [mean (M) ± SD 31.7 ± 25 mm vs. 26.9 ± 22 mm; effect size (80% CI) = -0.22 (-0.6 to 0.2)] and evening [(M ± SD 33.5 ± 28 mm vs. 25.6 ± 21 mm; effect size (80% CI) = -0.33 (-0.8 to 0.1)]. All secondary measures of breathlessness were higher with morphine as were nausea and constipation. CONCLUSION: This study does not support a Phase III study of ER morphine for people with PAH-associated chronic breathlessness. Recruiting to the target sample size was difficult, the direction of effect in every measure of breathlessness favored placebo and morphine generated more harms.

The Prospective Evaluation of the Net Effect of Red Blood Cell Transfusions in Routine Provision of Palliative Care.

BACKGROUND: Red Blood Cell (RBC) transfusions are commonly used in palliative care. RBCs are a finite resource, transfusions carry risks, and the net effect (benefits and harms) is poorly defined for people with life-limiting illnesses. OBJECTIVE: To examine the indications and effects of RBC transfusion in palliative care patients. DESIGN: This international, multisite, prospective consecutive cohort study. SETTING/SUBJECTS: Palliative care patients undergoing RBC transfusion. MEASUREMENTS: Target symptoms (fatigue, breathlessness, generalized weakness, or dizziness) were assessed before transfusion and at day 7 by treating clinicians, using National Cancer Center Institute Common Terminology Criteria for Adverse Events. Assessment of harms was made at day 2. RESULTS: One hundred and one transfusions with day 7 follow-up were collected. Median age was 72.0 (interquartile range 61.5-83.0) years, 58% men, and mean Australia-modified Karnofsky Performance Status (AKPS) of 48 (standard deviation [SD] 17). A mean 2.1 (SD 0.6) unit was tranfused. The target symptoms were fatigue (61%), breathlessness (16%), generalized weakness (12%), dizziness (6%), or other (5%). Forty-nine percent of transfusions improved the primary target symptom, and 78% of transfusions improved at least one of the target symptoms. Harms were infrequent and mild. An AKPS of 40%-50% was associated with higher chances of symptomatic benefit in the target symptom; however, no other predictors of response were identified. CONCLUSIONS: In the largest prospective consecutive case series to date, clinicians generally reported benefit, with minimal harms. Ongoing work is required to define the optimal patient- and clinician-reported hematological and functional outcome measures to optimize the use of donor blood and to minimize transfusion-associated risk.