All you need to read in the other general journalsBMJ 2011; 343 doi: http://dx.doi.org/10.1136/bmj.d5798 (Published 14 September 2011) Cite this as: BMJ 2011;343:d5798
Stent looks unsafe for adults with intracranial arterial stenosis
In November 2008, researchers began a trial of angioplasty and stent placement for adults with a stroke or transient ischaemic attack caused by an intracranial arterial stenosis. The trial ended early, less than three years later, when a data monitoring committee decided it was futile and probably unsafe to continue. Rates of death or stroke in the first month were 14.7% (95% CI 10.7% to 20.1%) in 224 adults given the best medical management and a stent compared with 5.8% (3.4% to 9.7%) in 227 controls managed with drugs alone. Twenty five of the 33 strokes in the stent group occurred within one day of the procedure. Another eight occurred within a week⇓.
The findings were unexpected, and follow-up will continue to try to find out why outcomes were so much worse, initially at least, for adults treated with a stent. Wingspan, a self expanding stent, was approved by the US Food and Drug Administration in 2005 for adults with symptomatic and severe intracranial stenoses. This is the first head to head trial of the stent against best medical management, say the researchers. Dual antiplatelet treatment with aspirin and clopidogrel combined with aggressive management of cardiovascular risk factors clearly worked better.
US trainees plagued by debt, distress, and a poor quality of life
When researchers asked a national cohort of US residents in training to fill in questionnaires about quality of life, burnout, and debt, 15% (2402/16 187) reported a quality of life that was “as bad as it can be” or “somewhat bad.” All respondents were in the first three years of postgraduate training in internal medicine. The overall response rate was 74.1%⇓.
High levels of emotional exhaustion (45.8%; 7394/16 154) and depersonalisation (28.9%; 4541/15 737)—cardinal symptoms of burnout—were also common.
Trainees on internal medicine residency programmes in the US are clearly distressed, say the authors. It matters because in fully adjusted analyses, distress was significantly associated with lower test scores in a routine yearly multiple choice exam. The differences were small but discernible and potentially important if worse test scores translate to worse patient care.
Debt was also linked to poor test performance in this survey. Around half the respondents owed at least $50 000 (£31 500; €36 500), and more than a quarter owed at least $150 000. These residents were more likely to report burnout than debt-free peers, and they achieved significantly lower scores in the test. Those owing more than $200 000 scored five points less than residents with no debt (99% CI 4.4 to 5.6)—a difference equivalent to missing out a whole year of training, say the authors.
Duodenal switch is a poor choice for super obese adults
A duodenal switch is one alternative to the Roux-en-Y gastric bypass for super obese adults who cannot lose weight any other way. A small trial has confirmed that a switch works better than a bypass, inducing significantly greater weight loss, and bigger improvements in serum lipid profiles during the first two years. The advantages end there, however. Both operations improved quality of life, blood pressure, and metabolic measures such as serum concentrations of glucose and insulin. But complications were twice as common (62% (18/29) v 32% (10/31)) and arguably more serious after duodenal switch operations. Among the 29 patients who had this type of surgery, one developed acute liver failure, two developed severe malnutrition, two more had serum concentrations of vitamin A low enough to cause night blindness, and one needed iron infusions for iron deficiency. There were no complications related to malnutrition or micronutrient deficiency after gastric bypass surgery. Abdominal pain, vomiting, diarrhoea, and small bowel obstructions occurred in both groups⇓.
The extra weight loss associated with a duodenal switch is simply not worth the risk, says a linked editorial (p 329). We have no evidence that this operation is any better than a bypass at prolonging lives, preventing heart disease, controlling diabetes, or curing sleep apnoea—the outcomes that really matter to patients with a body mass index over 50.
Commercial weight management outperforms standard primary care
Adults who need help to lose weight can start with their local primary care service, or try a commercial provider. Weight Watchers, a commercial provider with a global reach, recently funded one of the first trials to compare the two. Adults attending Weight Watchers lost twice as much weight over 12 months as those treated in primary care (5.06 v 2.25 kg; adjusted difference 2.77, 95% CI 3.5 to 2.03) and lost significantly more fat mass. Waistlines shrank by an extra 2-4 cm, depending on the analysis.
Participants were mostly women (668/772). They were overweight or obese, with a mean body mass index of 31 and were referred to the trial by primary care professionals in Germany, Australia, and the UK. While the control group met with a local primary care professional about once a month for guideline based help, advice, and care, the intervention group went free to weekly group sessions for weigh-ins, advice, and motivation. They also had online support, including a library of meal cards and recipe ideas.
Around half the participants defaulted before the end of the trial, but even in the most conservative analyses, Weight Watchers worked better than standard primary care. Should commissioners of weight loss services switch to commercial providers?
Some in the UK already have, says a linked comment (doi:10.1016/S0140-6736(11)61186-0), and now we need good cost effectiveness analyses to find out if tax payers are getting value for money. In the meantime, more work needs to be done to find and evaluate services acceptable to overweight and obese men.
Mild cognitive impairment is linked to a shorter life for older adults
We know that severe forms of cognitive impairment, including dementias, are associated with a shortened life expectancy. Older adults with mild cognitive impairment are also at risk, according to a cohort study from the US. Researchers screened 3957 adults aged over 60 with a simple tool called the short portable mental health status questionnaire and tracked them through the national death index for 13 years. Mild cognitive impairment was significantly associated with mortality, after adjusting for demographic profiles, lifestyle factors, and chronic illnesses (hazard ratio 1.184, 95% CI 1.051 to 1.334). The link was not explained by depression. As expected, mortality was higher still among those with moderate or severe cognitive impairment at baseline (1.447, 1.235 to 1.695).
Most other studies linking cognitive function and survival have used complex batteries of psychometric tests, say the authors. A simple screening tool of 10 questions, delivered in a primary care setting, may be enough to detect mild problems with important implications.
The adults in this cohort were recruited from urban primary care clinics run by a safety net healthcare system in the US. The authors caution against generalising to more affluent settings.
Graduated licensing helps protect the youngest drivers
Most US states allow 16 year olds to learn to drive, and all now have graduated licensing programmes that place restrictions on the youngest drivers for at least three months after licensure. The programmes vary, but they commonly include a period of supervised driving only, followed by a further period when those aged 16-18 can drive unsupervised if they don’t drive at night or carry more than one young passenger.
A decade of research suggests that these measures help reduce the risk of fatal crashes among teens, and the latest study confirms that they are particularly effective for 16 year olds. The time series analysis of data from all 50 states and the district of Columbia reported a 26% reduction in fatal crashes associated with the tightest restrictions (rate ratio relative to no restrictions 0.74, 95% CI 0.65 to 0.84). Results for older teens were more worrying. The programmes had no significant effect on fatal crashes among 17 year olds and seemed to increase the risk for 18 year olds (1.12, 1.01 to 1.23).
Perhaps teenagers are learning to drive later to avoid the restrictions, say the authors. Or perhaps the protected period causes a “rebound” effect when 18 year old drivers are finally exposed to the full range of risks on the road.
Extending the restrictions to all drivers under 21 may be one solution, and New Jersey is leading the way, says an editorial (p 1142). Researchers are watching carefully.
US adults remain naive about prescription drugs
US adults have a touching faith in their regulatory authority. In an online survey of close to 3000 adults, 39% believed that the Food and Drug Administration “only approves prescription drugs that are extremely effective.” A quarter believed that the regulator “only approves drugs that do not have serious side effects.”
Respondents also failed to grasp that drugs tested using clinical outcomes (reduction in heart attacks, say) were a safer choice than similar drugs tested using only surrogate outcomes (reduction in cholesterol), or that it was usually better to opt for a drug with an established track record over one that has just been approved. Simple messages such as “it takes time to establish the safety of new drugs” seemed to help, and in a randomised trial both directive and non-directive messages significantly increased the proportion of respondents making the right choice.
It will take time and effort to make people aware of the uncertain benefits and risks of approved drugs, say the authors. The Food and Drug Administration must do more to help the public interpret the unfettered direct to consumer advertising that follows a new approval. They urge the regulator to add a prominent warning to all new drugs—similar to the black triangle scheme in the UK—along with clear messages about the limitations of surrogate outcomes in drug trials.
Cite this as: BMJ 2011;343:d5798