Patient information leaflets: “a stupid system”.

The NHS’s multifarious patient information leaflets are inaccurate, inconsistent, and confusing, finds Margaret McCartney, and effort is duplicated because each trust commissions its own, often from the private sector

The so called patient revolution is nothing without quality information. And so the NHS is awash with patient information, especially leaflets, in hospital wards, outpatient clinics, and general practitioners’ surgeries. Some trusts commission leaflets from external, profit making companies; others write their own. But how efficiently does the health service coordinate them, and are leaflets tested for effectiveness on patients?

In a recent study researchers asked 128 trusts for leaflets given to patients after an inguinal hernia repair, and 93 trusts responded.1 Almost one in five trusts sent a leaflet created by a private company, Eido Healthcare. Others had inconsistent guidance on when to return to office work (ranging 1-6 weeks) or manual work (2-12 weeks). Similarly, leaflets gave conflicting advice about when to resume driving, sex, and sport. This means that patients are being given very different information about the effects of the same surgery, depending on where they live and which leaflets are used.

A similar study examined leaflets provided to patients who had been offered extracorporeal shockwave lithotripsy. The researchers found that the leaflets did not consistently mention common recognised complications and some were not mentioned at all.2 Another study, which examined patient information leaflets given for transrectal ultrasound guided prostate biopsy, again found wide variation, with drugs, analgesia, and complications often inadequately explained.3

“It’s a stupid system, a waste of money, and, without rigorous standards of searching and appraisal, much of the information is biased and misleading—especially in terms of fair representations of risk,” Muir Gray told the BMJ, reflecting on the current situation in the NHS. Gray is co-chair of the executive council of the Information Standard, an independent certification scheme funded by the Department of Health for organisations producing evidence based healthcare information for the public.

Gray said that a lack of coordination and slow uptake of the certification scheme by the NHS has meant that much information provided to patients is of poor quality. “Patients have a right to clean, unbiased information, but they can’t get that off the internet,” he said. “It’s not possible to communicate to a patient in 10 or 20 minutes everything about a decision. Knowledge is essential, but you can’t rely on the consultation—you don’t have the time. Therefore we need to supplement and complement face to face. You need that to help people reflect on their values, to discuss their fears and anxieties.”

The Information Standard, which is run by the for profit company Capita, offers a kitemark if the information presented is evidence based, clear, and accurate. Patients should also be involved and have tested the information.

Some 400 UK hospitals use Eido, a private company, to produce information leaflets for them. Eido’s website says that the company produces “informed consent patient information leaflets,” which it says “improve the doctor-patient relationship, reduce the risk of litigation and increase patient satisfaction.” They advertise both their Information Standard accreditation and ability to customise information locally.

Simon Parsons, a consultant surgeon in Nottingham, set up the company when he was a surgical registrar out of concern that the informed consent process, which was subject to then new General Medical Council guidance, was using poor quality patient information leaflets. Eido’s information leaflets are indemnified, and Parsons said, “In the 10 years we have supplied in the UK, not a single claim has been brought against us in terms of inaccurate patient information.” The company supplied audit data in support of its claim of patient satisfaction. The leaflets are not publicly available except through a hospital or surgeon who has access to them. East Cheshire NHS Trust makes one payment a year to Eido, which was for £6511 in 2012, the trust said in response to a request under the Freedom of Information Act.

Meanwhile, Guy’s and St Thomas’ NHS Foundation Trust has an online, freely available library of about 850 patient information leaflets, regularly updated, but all are produced in house.4 These are written by clinicians and healthcare professionals, and tested by patients or lay readers to ensure they can be easily understood. Anita Knowles, director of communications, told the BMJ that the trust ensures leaflets are necessary and would not duplicate a good leaflet from elsewhere. The patient publications team is made up of two staff team who call on additional resources as needed. They made a decision not to use external agencies because “it was just as cheap to do it ourselves. We wanted the control, as well as the ability to change information rapidly,” Knowles told the BMJ.

The problem of varying quality of leaflets is not new; in 1998 the BMJ published an investigation into the quality of leaflets on asthma given out by general practitioners. It found inaccuracies and outdated information from the NHS, drug companies, and charities.5 In an accompanying editorial, Angela Coulter, now a researcher at the University of Oxford, called for a national strategy.6

She told the BMJ that “progress has been slow.” The problem is that “the NHS still fails to take this seriously.” For example, printable patient information leaflets are available as part of the Emis computer system used by general practitioners, which are Information Standard accredited but which come with advertisements attached.

“In the patient’s eye, that can devalue it,” Coulter said. “At the moment, in most NHS trusts, there is no one who has responsibility, or, if they are junior, often they have no budget. Often leaflets are written with the best of intentions in someone’s free time, but they can end up amateurish, with the evidence and uncertainties not expressed clearly. Yet there has been so much work internationally into setting standards,” such as the Delphi method, a structured communication technique.

A spokesman told the BMJ that NHS England is launching a “major project” in September to standardise all information going out to patients, which will then go to the Information Standards Board for Health and Social Care for approval.7 One of the aims of this board, which works throughout the NHS, is to reduce inefficiencies through reducing replication. A spokesman said that there needed to be “clinically endorsed, consistent information available across the country,” which would “lead on the standardisation of all information going out to patients.”

The internet has given us a great gift of instant information sharing. The challenge now, Coulter emphasised, is to adopt high standards, updating information regularly, and making it easily accessible. The size of the NHS makes this hard to do, but it is wasteful to franchise out the core role of information provision to the private sector because each trust is paying again for the same information over and over. This is one area of the NHS where efficiency savings look ripe for the picking.

Source: BMJ



Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial).


Objective To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery.

Design Multicentre observer blinded randomised controlled trial.

Participants Patients undergoing laparotomy at 21 UK hospitals.

Interventions Standard care or the use of a wound edge protection device during surgery.

Main outcome measures Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient’s self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device.

Results 760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device.

Conclusions Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended.

Source: BMJ


The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: nested case-control study.


Objective To determine if the use of pioglitazone is associated with an increased risk of incident bladder cancer in people with type 2 diabetes.

Design Retrospective cohort study using a nested case-control analysis.

Setting Over 600 general practices in the United Kingdom contributing to the general practice research database.

Participants The cohort consisted of people with type 2 diabetes who were newly treated with oral hypoglycaemic agents between 1 January 1988 and 31 December 2009. All incident cases of bladder cancer occurring during follow-up were identified and matched to up to 20 controls on year of birth, year of cohort entry, sex, and duration of follow-up. Exposure was defined as ever use of pioglitazone, along with measures of duration and cumulative dosage.

Main outcome measure Risk of incident bladder cancer associated with use of pioglitazone.

Results The cohort included 115 727 new users of oral hypoglycaemic agents, with 470 patients diagnosed as having bladder cancer during follow-up (rate 89.4 per 100 000 person years). The 376 cases of bladder cancer that were diagnosed beyond one year of follow-up were matched to 6699 controls. Overall, ever use of pioglitazone was associated with an increased rate of bladder cancer (rate ratio 1.83, 95% confidence interval 1.10 to 3.05). The rate increased as a function of duration of use, with the highest rate observed in patients exposed for more than 24 months (1.99, 1.14 to 3.45) and in those with a cumulative dosage greater than 28 000 mg (2.54, 1.05 to 6.14).

Conclusion The use of pioglitazone is associated with an increased risk of incident bladder cancer among people with type 2 diabetes.

Source: BMJ


Improving antibiotic prescribing in acute respiratory tract infections: cluster randomised trial from Norwegian general practice (prescription peer academic detailing) .


Objective To assess the effects of a multifaceted educational intervention in Norwegian general practice aiming to reduce antibiotic prescription rates for acute respiratory tract infections and to reduce the use of broad spectrum antibiotics.

Design Cluster randomised controlled study.

Setting Existing continuing medical education groups were recruited and randomised to intervention or control.

Participants 79 groups, comprising 382 general practitioners, completed the interventions and data extractions.

Interventions The intervention groups had two visits by peer academic detailers, the first presenting the national clinical guidelines for antibiotic use and recent research evidence on acute respiratory tract infections, the second based on feedback reports on each general practitioner’s antibiotic prescribing profile from the preceding year. Regional one day seminars were arranged as a supplement. The control arm received a different intervention targeting prescribing practice for older patients.

Main outcome measures Prescription rates and proportion of non-penicillin V antibiotics prescribed at the group level before and after the intervention, compared with corresponding data from the controls.

Results In an adjusted, multilevel model, the effect of the intervention on the 39 intervention groups (183 general practitioners) was a reduction (odds ratio 0.72, 95% confidence interval 0.61 to 0.84) in prescribing of antibiotics for acute respiratory tract infections compared with the controls (40 continuing medical education groups with 199 general practitioners). A corresponding reduction was seen in the odds (0.64, 0.49 to 0.82) for prescribing a non-penicillin V antibiotic when an antibiotic was issued. Prescriptions per 1000 listed patients increased from 80.3 to 84.6 in the intervention arm and from 80.9 to 89.0 in the control arm, but this reflects a greater incidence of infections (particularly pneumonia) that needed treating in the intervention arm.

Conclusions The intervention led to improved antibiotic prescribing for respiratory tract infections in a representative sample of Norwegian general practitioners, and the courses were feasible to the general practitioners.

Source: BMJ


Lenalidomide plus Dexamethasone for High-Risk Smoldering Multiple Myeloma.


For patients with smoldering multiple myeloma, the standard of care is observation until symptoms develop. However, this approach does not identify high-risk patients who may benefit from early intervention.


In this randomized, open-label, phase 3 trial, we randomly assigned 119 patients with high-risk smoldering myeloma to treatment or observation. Patients in the treatment group received an induction regimen (lenalidomide at a dose of 25 mg per day on days 1 to 21, plus dexamethasone at a dose of 20 mg per day on days 1 to 4 and days 12 to 15, at 4-week intervals for nine cycles), followed by a maintenance regimen (lenalidomide at a dose of 10 mg per day on days 1 to 21 of each 28-day cycle for 2 years). The primary end point was time to progression to symptomatic disease. Secondary end points were response rate, overall survival, and safety.


After a median follow-up of 40 months, the median time to progression was significantly longer in the treatment group than in the observation group (median not reached vs. 21 months; hazard ratio for progression, 0.18; 95% confidence interval [CI], 0.09 to 0.32; P<0.001). The 3-year survival rate was also higher in the treatment group (94% vs. 80%; hazard ratio for death, 0.31; 95% CI, 0.10 to 0.91; P=0.03). A partial response or better was achieved in 79% of patients in the treatment group after the induction phase and in 90% during the maintenance phase. Toxic effects were mainly grade 2 or lower.


Early treatment for patients with high-risk smoldering myeloma delays progression to active disease and increases overall survival.

Source: NEJM



How Coffee Could Save Your Life.

Yet another reason to indulge your caffeine addiction.


To hear most recent research tell it, coffee is a miracle drink. The magic beans will ward off skin cancer and Alzheimer’s, reduce heart failure and diabetes risks, heighten focus, and maybe even protect liver health. Oh, and decrease suicide risk, according to the newest study that validates our coffee addictions.

According to a study performed by the Harvard School of Public Health and published this month in The World Journal of Biological Psychiatry, people who drink two to four cups of java each day are less likely to commit suicide than those who don’t drink coffee, drink decaf, or drink fewer than two cups each day. The study followed over 200,000 people for at least 16 years. And it’s not just a weak link: the researchers found that the suicide risk was cut by around 50 percent for caffeine fiends.

This isn’t the first time that researchers have discovered that coffee and smiles might go hand-in-hand. A 2011 study found that women who drink coffee cut their risk of depression by 15 percent compared to those who don’t. Michel Lucas, the head researcher of the most recent study, told The Huffington Post that coffee addicts can thank caffeine for the good news. The drug may actually act like a mild anti-depressant by tweaking levels of happy hormones like serotonin and dopamine.

Of course, there’s plenty of research out there that doesn’t look so kindly upon coffee drinkers. Recently, the New Yorker published an article arguing that while coffee may heighten focus, that means it also puts a squeeze on creativity. And of course, coffee’s well-known negative effects like insomnia and disturbed sleep cycles still hold.

Regardless, we’ll raise our mugs to this most recent study for giving us one more validation for our vice.




Coffee: Drink More, Live Longer?

Older coffee drinkers who really like their cup of joe appear to have a leg up in the longevity department.

Kicking your morning off with a cup of joe may provide more than a caffeine boost. A recent study from the National Institutes of Health (NIH) found that older coffee drinkers — even those who swill decaf — have a lower risk of death than those who don’t drink coffee.

Cups of cappuccino sit on a table during the World Coffee Conference in Guatemala City

“Coffee is one of the most widely consumed beverages, both in the United States and worldwide,” the authors of the study write. “Since coffee contains caffeine, a stimulant, coffee drinking is not generally considered to be part of a healthy lifestyle. However, coffee is a rich source of antioxidants and other bioactive compounds.”

Previous studies have looked at the link between coffee consumption and major causes of death with varying results. ”There has been a concern that drinking coffee might increase risk of death, but I think our findings show evidence against that,” says lead researcher Dr. Neal Freedman of the division of cancer epidemiology and genetics at the National Cancer Institute (NCI), which is part of the NIH.

In the study, researchers from the NCI analyzed 229,119 men and 173,141 women ages 50 to 71 who participated in the National Institutes of Health–AARP Diet and Health Study. The participants filled out a questionnaire about their coffee intake at the beginning of the study in 1995-1996 and were followed until their death or the study’s completion in December 2008. The participants were sorted into 10 coffee-consumption-frequency categories ranging from zero to six cups per day. The majority of the participants also indicated whether they were regular or decaf drinkers.

In relation to men and women who did not drink coffee, those who consumed three or more cups per day had approximately a 10% lower risk of death. Men who drank six or more cups of coffee per day had a 10% lower risk of death compared with men who did not drink coffee. Women who drank six or more cups a day had a 15% lower risk.

Overall, coffee drinkers were more likely to smoke cigarettes and consume red meat and alcohol than those who didn’t drink coffee. However, when the researchers adjusted for these risk factors, they found that drinking coffee was inversely related to death. Coffee drinkers were less likely to die from heart disease, respiratory disease, stroke, injuries and accidents, diabetes and infections, but there did not seem to be an association with decreased cancer deaths.

(MORECan’t Get Enough Coffee? It Might Be in Your Genes)

Since the study was observational only, the authors couldn’t conclude that coffee drinking actually reduces death risk. The researchers note that coffee intake was recorded in a self-report at a single time point and may not reflect long-term consumption patterns. As a result, more research is needed to see if the trend holds true across varying populations. But the researchers speculate that if the relationship between coffee drinking and decreased death risk is directly associated, it likely has to do with coffee’s many compounds.  ”There are an estimated 1,000 different compounds in coffee that can have a range of effects,” says Freedman. “Caffeine is the most studied, but we don’t think it has to do with caffeine because the same results were found in decaf drinkers. Coffee also has a lot of antioxidants, and many other compounds are associated with inflammation and insulin resistance.”

Further analysis of coffee’s compounds is needed to understand how the mechanisms work. And how you drink your coffee also matters. “How the coffee is prepared is also important,” says Freedman. “Some people like espresso, some like French press, and these can change the compounds in the coffee and we were unable to study that.”

Coffee abstainers, don’t panic: Freedman indicates there’s no need to hurry out for a Venti latte. “It’s important that we look at these findings cautiously,” he says. “The different compounds in coffee can have different effects on health for different people.”

Source: New England Journal of Medicine.


Acetaminophen Linked to Serious Skin Reactions.

Acetaminophen is associated with potentially fatal skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, the FDA announced Thursday. The agency notes that these reactions likely are rare.

Patients taking acetaminophen or another pain reliever/fever reducer who develop skin rashes or reactions should stop taking the drug and seek immediate medical attention. Patients who have experienced these reactions in the past while taking acetaminophen should not take the drug again and should discuss alternatives with their healthcare provider.

The warning is based on a small number of published cases and the FDA’s own adverse event reporting system.

Source: FDA 


Is the Prevalence of Dementia Changing?



In England, the prevalence fell from 8.3% to 6.5% during the past 20 years.

Dementia in the growing elder population is an important driver of healthcare costs and a matter of societal concern. Some trends might increase dementia prevalence (e.g., longer lifespan, increasing obesity and diabetes, survival after stroke), whereas others might reduce it (e.g., more-effective prevention of cardiovascular disease, improved early-life education). Between 1989 and 1994, researchers estimated dementia prevalence in three geographic areas in England by interviewing a population-based sample of more than 7500 older adults (age, ≥65). Now, investigators report results of an identical survey in a similar sample from the same areas between 2008 and 2011.

The overall prevalence of dementia fell significantly, from 8.3% to 6.5%. In care facilities, dementia prevalence rose from 58% to 73%; however, the proportion of elders living in such facilities declined from 5% to 3%. In both surveys, dementia prevalence was higher in women than in men in care and community settings.


This rigorous study is a persuasive piece of evidence that, at least in some settings, the prevalence of dementia in elders is declining and might be sensitive to societal efforts to improve education, primary prevention, and healthcare delivery.

Source: NEJM

Ultrasound Confirms Tube Position During Cardiopulmonary Resuscitation.

In this small study, the positive predictive value of ultrasound to confirm endotracheal tube placement during active compressions was 98.8%.
Confirming correct endotracheal tube (ETT) placement during cardiopulmonary resuscitation (CPR) can be challenging. In a prospective observational study, researchers in Taiwan assessed the accuracy of real-time tracheal ultrasonography in 89 cardiac arrest patients (age range, 24–98 years) receiving emergency intubation during CPR. Patients with severe neck trauma, neck tumors, or history of neck surgery (including tracheotomy) were excluded. The gold standard for correct ETT placement was defined as bilateral auscultated breath sounds with good capnography waveform and exhaled carbon dioxide >4 mm Hg after at least 5 breaths.

Three senior emergency medicine residents supervised by experienced faculty performed tracheal ultrasonography during and immediately after ETT insertion, with most scans taking 10 seconds or less. Observation of a single air-mucosa interface with comet-tail artifact confirmed tracheal placement. Seven patients (7.8%) had esophageal intubations. Sensitivity, specificity, and positive and negative predictive values of tracheal ultrasound for identifying ETT position were 100%, 86%, 99%, and 100%, respectively.


Aspiration devices are the current standard for confirmation of tracheal tube placement during CPR when end-tidal CO2 is not detectable. Ultrasound shows promise in this setting, but the failure to identify 1 in 7 esophageal intubations is concerning. The key to establishing the value of ultrasound for tracheal tube confirmation lies in demonstration of its ability to detect 100% of esophageal intubations. We are not there yet.

Source: NEJM