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CANNOT BE BADGERED: a sorry tale from MASCOT
Clinical trials in children are few and far between so funding from NIHR for MASCOT, a large clinical trial comparing treatment options at in children whose asthma is uncontrolled on low dose inhaled corticosteroids, was welcome. However, what followed was a litany of frustrating delays due to an astonishing burden of bureaucracy, communication problems, governance issues and difficulties with recruitment (See page 457). As a result, the trial was not completed and over £1 million of public money was wasted. While this fiasco was rumbling on, the BADGER trial, starting about the same time, was successfully completed in the USA. What can be learnt from this disaster? It strikes us that there are three areas where immediate reform should be possible. First, a reliable and quick supply of placebo inhalers and tablets should be available for studies of this sort. Second, research staff should have direct access to patient lists in primary and secondary care and should be able to communicate directly with patients, unless individuals have opted out. Third, the Multicentre Research Ethics Committee decision and local Governance processes must be speeded up. Ros Smyth (See page 459) is optimistic that progress will be made in some of these areas if the recommendations of the new Health Research Agency are acted upon. We hope she's right. However, this is just one illustration of our national obsession with process (wearisomely correct in MASCOT) at the expense of outcome (a New England Journal of Medicine paper for BADGER).
High, Hot, and a Helluva lot
Navaratnam and colleagues show that the age-standardised incidence of idiopathic pulmonary fibrosis in the UK has been rising by about 5% per annum over the last 40 years. They estimate over 5000 new cases per year. This data seems robust as independent estimates were made from two separate sources: a large GP database, and death registrations. Increased case ascertainment because of improved diagnostics is unlikely to account for such a large increase as the prognosis did not change appreciably during the observation period. The study estimated a median survival of 3 years, reinforcing the dismal prognosis of idiopathic pulmonary fibrosis. We do not know what causes this condition, why the incidence is increasing and how best to treat it. It is clear that this is an important public health problem and that more research is needed urgently. See page 462.
It's not over until it's over
Neonatal intensive care units (NICU) have repeatedly pushed back the boundaries of what is viable. However, from the brilliance of the acute care of tiny babies has come a cohort of respiratory casualties. We all know that premature babies, even if they require no intensive care, leave hospital with lower than normal lung function. Drysdale et al confirm that being born prematurely is associated with decrements in lung function, but more importantly, show that this affects the severity of respiratory viral infections. The infants admitted to hospital had worse lung function prior to the viral infection than those who did not. Clearly this matters in the short term, but what is the long-term fate of these babies with likely fixed chronic airflow limitation? Will they be the new phenotype, pauci-inflammatory COPD cohort in years to come? How will this interact with smoking, which is all too common in NICU survivors? This is an issue the respiratory community needs to address. Just because these babies have been successfully salvaged in NICU is far from meaning that their problems are over. See page 468.
Another tombstone in the graveyard of good ideas
Vitamin D is well known to be at the root of all evil and giving Vitamin D cures everything from steroid resistance in asthma to toddler tantrums (we wish!). Animal models have demonstrated the importance of optimising Vitamin D status in the developing fetal lung. So it is therefore obvious that optimising Vitamin D status during pregnancy and early childhood is a good thing, and only a matter time before one of the many ongoing birth cohort studies demonstrated this, right? No, wrong: the KOALA study (more than 400 children, followed from birth to age 6–7) were unable to show any effect of either childhood Vitamin D levels, childhood Vitamin D intake, or recommended use of Vitamin D≥10 μg/day during pregnancy, on childhood spirometry. A salutary lesson: sometimes research into the blindingly obvious does not give the obvious answers. See page 474.
Nervous about your lungs?
This 72-year-old woman presented with neurological problems, and was found to have lung and spinal cord nodules. See page 546 for this month's pulmonary puzzle, where things are not quite as they seem.
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