Vax rates may be underestimated
IMMUNISATION coverage rates appear to have been significantly underestimated in the Australian Childhood Immunisation Register, according to a short report published in the MJA. The authors studied a cohort of children in south-eastern Sydney aged 12‒15 months in 2002. According to the Register, 81% of children in the region had received all vaccination doses scheduled for the first year of life. However, systematic follow up of one third of the children recorded as being overdue for one or more doses found the overall proportion who were up-to-date was at least 91%. The authors conducted a similar study in 2013 that focused on children aged 12‒15 months in another area in Sydney, where the Register estimated a coverage level of 87%. Of the 112 children recorded as being overdue for one or more vaccinations, and whose records were checked with providers and parents, 33% were found to be up-to-date, increasing the estimated coverage rate to at least 91%. The authors said their findings demonstrated that, in some localities, the true level of coverage was higher than that reflected in the Register. Possible reasons why some children were incorrectly recorded in the Register included GPs not understanding the reporting process, data being entered incorrectly, or technical problems in practice software. The authors said it was an important public health priority to identify the populations where coverage was genuinely low, so that education and other appropriate efforts could be properly focused. “To obtain a more accurate picture of variations in coverage, investment is required to provide ongoing support to general practice staff and to ensure that practice software interfaces seamlessly with the Register”, the authors wrote.
 
Balloon autoinflation treatment improves otitis media
NASAL balloon autoinflation is a feasible treatment option in primary care for children with otitis media with effusion, research published in the CMAJ has found. The randomised controlled trial, involving 43 UK family practices, included 320 children aged 4–11 years with a recent history of ear symptoms and otitis media with effusion in one or both ears. The children were randomised to receive either autoinflation three times daily for 1‒3 months in addition to their usual care, or standard care alone. Clearance of middle-ear fluid at 1 and 3 months was assessed by experts masked to allocation. The authors found those who received autoinflation were more likely to have a normal tympanogram at 1 month than children in the control group. Overall, children in the autoinflation arm experienced fewer days with any symptom or problem than those who received standard care. The authors found that autoinflation also produced greater improvements in ear-related quality of life. Compliance was 89% at 1 month and 80% at 3 months, and adverse events were mild, infrequent and not markedly different from those in the control group. The authors said the method could possibly be used in many symptomatic children, and could improve management and outcomes in primary health care systems. “Wider use of nasal balloon autoinflation could address the present lack of treatment options for children with symptomatic otitis media with effusion”, they wrote. However, autoinflation might not be suitable for all children, especially those aged under 4 years, and required ongoing commitment to treatment. “Further research is needed for very young children, and to inform prudent use across different health settings”, the authors said.
 
Mode of delivery may influence placebo outcomes
NOT all placebos are equal, and the mode of delivery can influence the treatment outcome, according to a systematic review published in the Annals of Internal Medicine. The authors evaluated 149 randomised trials that both reported pain outcomes in the treatment of knee osteoarthritis in adults aged 45‒76 years with widely used pharmaceuticals, and compared them with one of four placebo types — oral, intra-articular, topical and oral plus topical. Placebo effects were evaluated using a differential model, and it was found that intra-articular and topical placebo had significantly greater effect sizes in reducing pain than oral placebo. The model found marked differences in the relative efficacies and hierarchy of the active treatments compared with a network model that considered all placebos equivalent. They said their analysis supported the hypothesis that placebo treatments can exert clinically relevant effects, and that the potential for differential placebo effects needed to be considered when assessing the relative efficacies and rankings of active treatments against different placebos. Clinicians should be aware of the “practical reality that a substantial portion of the overall benefit observed and used in clinical practice may be influenced by the mode of treatment delivery”. These differences must also be incorporated into the design of future clinical studies, the authors said.
 
Pharma companies delay adverse event reports
AN analysis of quarterly US Food and Drug Administration (FDA) Adverse Event Reporting System data for nearly 10 years has found evidence that drug manufacturers delay reporting serious adverse events (AEs). The analysis, published in JAMA Internal Medicine, found reports on AEs that resulted in patient deaths were more likely to be delayed. The study included more than 1.6 million AE reports and used Kaplan-Meier estimates to identify that 9.94% of reports (40 464 with patient death and 119 919 without patient death) were not received by the FDA within the 15-day threshold for the initial receipt of information. The analysis found 90.71% of events without patient death were reported to the FDA within the 15-day threshold, compared with 88.25% for events involving patient death. The researchers said it was possible that manufacturers “spend additional time in verifying reports concerning deaths”. They said the findings were likely to be an underestimate of the overall underreporting or misreporting of AEs “given the anecdotal evidence of FDA warning letters to manufacturers alleging downward misclassification of serious AEs”. “While increased enforcement may decrease violations, a simple alternative would be to recommend direct submission of reports to the FDA rather than via the manufacturer”, they wrote. An accompanying editor’s note said reporting delays should never occur “as they mean that more patients are exposed to potentially avoidable serious harm, including death”.
 
Young cancer patients not told of impacts on fertility
US population-based research has found that less than 70% of adolescent and young adult (AYA) patients with cancer are told that their treatment may affect their fertility, with male patients more than twice as likely to be told about fertility preservation options than females. The research, published in Cancer, found that discussions and actions surrounding fertility preservation in AYA patients with cancer were associated with medical and socioeconomic factors and with child-rearing status. The study included 459 AYA patients (283 men, 176 women) diagnosed with cancer between 2007 and 2008. Questionnaires were used to identify the factors associated with not discussing the effects of therapy on fertility or fertility preservation options, and with not making arrangements to preserve fertility. About 60% of the patients were white. Most had private health insurance, had no comorbid conditions, and were being seen by a medical oncologist. Nearly one-third of males reported making provision for fertility preservation, a rate 4‒5 times higher than that for females. Men without insurance, without a college degree, and those raising children were less likely to discuss fertility preservation with healthcare providers. Among those who reported a reason for not making fertility preservation arrangements, 41% of men and 52% women cited access reasons, including cost issues and lack of awareness of options. About a third of male patients and half of female patients reported health-related reasons, including not wanting to delay treatment, the physician advising against delaying treatment, and concern about the effect of cancer on future offspring. The authors said the observed gender differences probably reflected the fact that oocyte cryopreservation was only available on an experimental basis at the time the patients were diagnosed. The access and health-related reasons for not making fertility preservation arrangements highlighted the need for reducing costs and improving insurance coverage. They wrote that partnerships between cancer health care providers and fertility experts should “develop strategies that increase awareness of fertility preservation options and decrease delays in cancer therapy as fertility preservation for AYA patients with cancer improves”.
 
Mothers missing out on advice about infant care
MANY mothers receive inconsistent or no advice on important aspects of infant care, including safe sleep practices and breastfeeding, a US study published in Pediatrics has found. The authors surveyed a nationally representative sample of 1031 mothers of infants aged 2‒6 months. Survey questions assessed the advice received from doctors, birth hospital nurses, family and media regarding immunisation, breastfeeding, sleep position, sleep location and pacifier use. Weighted frequencies of no advice and advice consistent with official recommendations were calculated to obtain prevalence estimates. The authors found that doctors were the most common source of reported advice, but around 20% of mothers reported having received no advice from doctors on breastfeeding or infant sleep position, and more than 50% reported no advice regarding sleep location or pacifier use. Reported advice from nurses was generally similar. The study authors said it was possible some health professionals might choose to avoid controversy or lengthy conversations about potentially controversial guidelines in a busy, time-pressured practice. The prevalence of advice from family or media was 20%‒56% for nearly all care practices, and was often inconsistent with recommendations by healthcare workers. The authors wrote that their research could help identify important targets for public health efforts to improve adherence to advice and official recommendations. Family and media also represented an untapped resource for advice to mothers of infants, the authors wrote. An accompanying commentary said the results were a “wake up call” for paediatricians, and that “we can and must do a better job of engaging fully in evidence-informed, culturally appropriate public discourse that transforms social norms about the necessity of providing a safe sleep environment for infants”.
 

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