Patient experiences of as-needed budesonide-formoterol by Turbuhaler® for treatment of mild asthma; a qualitative study.

BACKGROUND: Combination low-dose budesonide-formoterol, taken as-needed for symptom relief reduces exacerbation risk and is recommended for treatment of mild asthma. The NovelQ qualitative study explored patients' attitudes toward using this novel therapy. METHODS: Adults with mild asthma using reliever-only treatment were randomised to as-needed budesonide-formoterol Turbuhaler® in a multinational, 52-week open-label randomised controlled trial (NovelSTART-ACTRN12615000999538). A subgroup were interviewed to explore their attitudes to use of as-needed budesonide-formoterol after receiving it for ≥10 months. Semi-structured interviews were conducted until saturation, audio-recorded, and thematically analysed. RESULTS: Analysis of 35 participants (66% female; mean age 43.5 [range 18-74]; mean Asthma Control Questionnaire score 1.09 ± SD0.55) interviews identified 5 themes, each including both barriers and facilitators to therapy use. Themes were: 'Treatment effectiveness' i.e. how well symptoms were relieved and/or prevented; 'Lifestyle fit of the regimen' e.g. the extent to which the treatment regimen integrated into the patient's daily life; 'Attitudes toward medication use and safety' e.g. openness for new reliever treatments, beliefs about treatment necessity or side effects; 'Device attributes' e.g. perceived ease of use; and 'Doctor-patient relationship' e.g. impact of health professional support on new treatment acceptance. CONCLUSIONS: A wide range of factors seem to drive the opinions of mild asthma patients on as-needed budesonide-formoterol therapy. Many patients perceived both positive and negative treatment attributes, and their individual evaluation of these attributes determined their likelihood of using it after the study. Supportive patient-physician interactions appear key to addressing patient barriers. Recommendations for patient-centred discussions, developed from this research, are provided.

Obesity, underweight and BMI distribution characteristics of children by gross national income and income inequality: results from an international survey.

BACKGROUND: Economic wealth and income inequality may impact on childhood BMI distribution by affecting overconsumption of food and sedentary forms of transportation and entertainment across the whole or some of the population. OBJECTIVES: To determine whether BMI distribution of children differs by gross national income (GNI) per capita and Gini index derived from World Bank data. METHODS: Secondary analysis of largely self-reported height and weight data from a multi-country, cross-sectional study (ISAAC), of 77,963 children aged 6-7 (from 19 countries) and 205,388 adolescents aged 13-14 (from 36 countries), were used to examine underweight vs obesity prevalence and BMI distribution skewness, median and dispersion. RESULTS: Children and adolescents from 'lower' GNI countries had higher prevalence of underweight than those from 'higher' GNI countries (6% vs 3%, p = 0.03; 2% vs 1%, p = 0.05 respectively), but the prevalence of obesity was not different (2% vs 5%, p = 0.29; 2% vs 2%, p = 0.66). BMI distribution of participants from 'higher' GNI countries had higher median, without significant difference in skewness or dispersion compared to 'lower' GNI countries (higher medians +1.1 kg/m2 for 6-7 year olds, and + 0.7 kg/m2, +1.2 kg/m2 for 13-14 year old girls and boys respectively). Gini index was not associated with underweight or obesity prevalence in either children or adolescents, nor with any BMI distribution characteristics with one exception. Adolescent girls from higher income inequality countries had a greater median BMI (+0.7 kg/m2) and a less skewed BMI distribution. CONCLUSIONS: It appears that the obesogenic impact of economic prosperity affects all children similarly. Income inequality may have a gender specific effect affecting BMI distribution in adolescent girls.

Birth weight and subsequent body mass index in children: an international cross-sectional study.

BACKGROUND: The reported association between birth weight and subsequent body mass index (BMI) is conflicting. OBJECTIVES: To examine the relationship between birth weight and BMI in children aged 6-7 years. METHODS: Secondary analysis of data from a multi-centre, multi-country, cross-sectional study (International Study of Asthma and Allergies in Childhood (ISAAC) Phase Three). Parents/guardians of children aged 6-7 years completed questionnaires about their children's birth weight, current height and weight and whether their mother smoked in the first year of the child's life. A general linear mixed model was used to determine the association between BMI and birth weight. RESULTS: A total of 72 111 children (17 countries) were included in the analysis. There was a positive association of birth weight with BMI (for each kg increase in birth weight the BMI at 6-7 increased by 0.47 (SE 0.02) kg/m2 ; p < 0.0001) with a clear gradient by birth weight category. There was no statistically significant interaction between birth weight and Gross National Income (GNI). CONCLUSIONS: There is a positive linear relationship between birth weight and BMI in 6-7 year old children, which is present in both high and low income countries.

Reference ranges for serum periostin in a population without asthma or chronic obstructive pulmonary disease.

BACKGROUND: The clinical utility of serum periostin as a type 2 biomarker in asthma is limited by lack of reference range values derived from a population without respiratory disease. OBJECTIVE: To derive age- and sex-related reference intervals for serum periostin from an adult population without asthma or COPD. METHODS: Serum periostin levels were measured in 480 individuals, comprising 60 female and 60 male adults in each of the 18- to 30-year, 31- to 45-year, 46- to 60-year and 61- to 75-year age groups. Key exclusion criteria included a doctor's diagnosis of asthma, chronic bronchitis or COPD, and a history of wheezing or use of respiratory inhalers in the last 12 months. The distribution of periostin and logarithm-transformed periostin levels was derived, and 90% confidence intervals for an individual prediction were calculated. RESULTS: The distribution of serum periostin was right skewed with a mean (SD) periostin of 51.2 (11.9) ng/mL, median (IQR) 50.1 (43.1 to 56.9) ng/mL and range 28.1 to 136.4 ng/mL. There was no association between logarithm periostin and age or sex, although levels were low in current smokers. The 90% confidence limits for periostin were 35.0 and 71.1 ng/mL. CONCLUSIONS AND CLINICAL RELEVANCE: Serum periostin levels in adults without asthma or COPD are similar to those in adults with asthma. Serum periostin measurements do not need to be adjusted to take account of a patient's age or sex, although levels are lower in current smokers. Reference values for serum periostin levels in adults without asthma or COPD are provided.

Venous thromboembolism rates in patients with lower limb immobilization after Achilles tendon injury are unchanged after the introduction of prophylactic aspirin: audit.

UNLABELLED: ESSENTIALS: We audited venous thromboembolism (VTE) in Achilles injuries after the use of prophylactic aspirin. We audited 218 patients with Achilles injury requiring lower limb immobilization for ≥ 1 week. Fourteen patients (6.4%, 95% CI 3.6% to 10.5%) developed symptomatic and confirmed VTE. The incidence was similar to the 6.3% identified in the same patient group prior to the use of aspirin. BACKGROUND/OBJECTIVE: We report a follow-up audit of the incidence of venous thromboembolism (VTE) in patients requiring lower limb immobilization because of Achilles tendon injury, since the introduction of a policy to routinely prescribe 100 mg of aspirin daily. PATIENTS/METHODS: We studied 218 patients aged 18-65 years who attended the Orthopaedic Assessment Unit at Wellington Hospital between January 2013 and December 2014 with Achilles tendon injury requiring lower limb immobilization for ≥ 1 week. Information on assessment of VTE risk, prescription of aspirin and symptomatic VTE occurring within 70 days of immobilization was obtained and compared with the same information collected with the same method in the same patient group between January 2006 and December 2007, before the policy to routinely prescribe aspirin was introduced. RESULTS: A total of 189 of 218 (93%) patients were prescribed aspirin, as compared with 0.5% previously. Fourteen patients (6.4%, 95% confidence interval 3.6-10.5%) developed symptomatic radiologically confirmed VTE (10 distal deep vein thromboses [DVTs], two proximal DVTs, one pulmonary embolism [PE], and one PE with distal DVT). Aspirin was prescribed to all patients who subsequently developed a VTE; in one of 14, a recognized risk factor was documented. The VTE incidence was similar to the 6.3% identified in the previous audit. CONCLUSION: Lower limb immobilization following Achilles tendon injury confers a high risk of VTE even with aspirin prophylaxis. Consideration should be given to prophylaxis with low molecular weight heparin during lower limb immobilization following Achilles tendon injury, as this has proven efficacy in this clinical situation.

Upper extremity deep vein thrombosis in a TV cameraman.

We report the case of a 40-year-old right-handed man who developed a right subclavian vein thrombosis due to work as a TV cameraman. He presented with a sudden onset of marked swelling and blue discolouration of his right arm 3 weeks after the most strenuous and prolonged episode of TV camera work that he had ever undertaken. This involved carrying a 9kg camera on his shoulder, with his right arm flexed and abducted, for a 60min period with provocation of severe pain and marked discomfort persisting during the subsequent 3 weeks before presentation. A clinical diagnosis of upper extremity deep vein thrombosis (UEDVT) was made, with the diagnosis confirmed by ultrasound. He was treated with catheter-induced thrombolysis and a 3 month course of anticoagulation. He was advised that his UEDVT was caused by his occupation and that he should no longer work as a cameraman. This case shows the importance of identifying any occupational cause of UEDVT.

Association between breastfeeding and body mass index at age 6-7 years in an international survey.

BACKGROUND: Breastfeeding is believed to reduce children's risk for obesity but data are conflicting. It is also uncertain if breastfeeding has different effects on obesity in high- and low-income countries. OBJECTIVES: This study aimed to investigate the association between having been breastfed and body mass index (BMI) in 6- to 7-year-old children in a large international survey. METHODS: Parents/guardians reported whether their child had been breastfed and their current height and weight. Some centres measured height and weight directly. Analyses adjusted for whether height and weight were reported or measured, child's age, sex, country gross national income and centre. RESULTS: Data were available for 76,635 participants from 31 centres in 18 countries. Reported breastfeeding rates varied from 27 to 98%. After adjusting for potential confounders, the estimated BMI difference was 0.04 kg m(-2) lower among those who had been breastfed (P = 0.07). The risk for being overweight or obese was slightly lower among breastfed children (odds ratio = 0.95, P = 0.012). There was no evidence that the association between breastfeeding and BMI was different in lower income countries compared with higher income countries. CONCLUSIONS: The findings suggest that breastfeeding has little impact on children's BMI. Increasing breastfeeding is unlikely to reduce the global epidemic of childhood obesity.

The association between paracetamol use and asthma: causation or coincidence?

A better understanding of the causation of asthma and allergic disorders could potentially lead to intervention strategies that reduce their prevalence and severity. One potential causative factor is the use of paracetamol. Most of the evidence for the link with asthma is from non-experimental studies of paracetamol exposure in utero, infancy, childhood and adult life; however, it has been difficult to rule out confounding and bias in the associations observed. The two randomized clinical trials of the effect of paracetamol in patients with asthma have been difficult to interpret, due to methodological issues. There have been no randomized controlled trials of paracetamol use and the development of asthma. Both asthma and paracetamol use are common, and so even if there is a relatively small effect of paracetamol exposure on the development of asthma or its severity, then such an effect would be of major public health significance. It is proposed that randomized controlled trials of the effect of paracetamol on the development of asthma and its severity are a high research priority.

Randomized controlled trial of asthma risk with paracetamol use in infancy--a feasibility study.

BACKGROUND: There is non-experimental evidence that paracetamol (acetaminophen) use may increase the risk of developing asthma. However, numerous methodological issues need to be resolved before undertaking a randomized controlled trial to investigate this hypothesis. OBJECTIVE: To establish the feasibility of a randomized controlled trial of liberal paracetamol as usually given by parents/guardians vs. a comparator (restricted paracetamol in accordance with WHO guidelines, ibuprofen or placebo), and childhood asthma risk. METHODS: Questionnaires were completed by parents/guardians of infants admitted to Wellington Hospital with bronchiolitis to assess views about comparator treatments. Subsequently, infants of parents/guardians who provided informed consent were randomized to restricted or liberal paracetamol use for 3 months with paracetamol use recorded. RESULTS: Of 120 eligible participants, 72 (60%) parents/guardians completed the questionnaire. Ibuprofen, restricted paracetamol and placebo were acceptable to 42 (58%), 29 (40%) and 9 (12%) parents/guardians, respectively. 36 (30%) infants were randomized to restricted or liberal paracetamol. Paracetamol use was greater for the liberal vs. restricted group for reported [Hodges-Lehmann estimator of difference 0.94 mg/kg/day (95% CI 0.2-3.52), P = 0.02] and measured use [Hodges-Lehmann estimator of difference 2.11 mg/kg/day (95% CI 0.9-4.18), P = 0.004]. The median reported and measured use of paracetamol was 2.0-fold and 3.5-fold greater in the liberal vs. restricted group. CONCLUSIONS AND CLINICAL RELEVANCE: Although separation in paracetamol dosing is likely to be achieved with a liberal vs. restricted paracetamol regime, ibuprofen is the preferred comparator treatment in the proposed RCT of paracetamol use and risk of asthma in childhood.

Immediate care of open extremity fractures: where can we improve?

Clear guidelines are set by the British Orthopaedic Association (BOA) and British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) on the preoperative management of open fractures. This as well as the clinical consequences of poor management of open fractures means the patient workup for surgery is important as well as the timing of surgery. Experience suggests few patients are managed 100% as per the guidelines and we look to test this hypothesis. A retrospective analysis was undertaken of all open long bone fractures (total 133), excluding hand injuries, which presented to a district general hospital over a 5-year period. The implementation of 7 defined key tasks for initial management was recorded. 101 cases were eligible, with the majority of cases (71.4%) having initial orthopaedic assessment outside normal working hours. The mean number of tasks completed was 3.23/7. Assessment out of hours was associated with less tasks being implemented but doctor seniority and the presence of polytrauma made no difference to the quality of acute care. Staff involved in the acute care of open fractures require targeted education to improve the delivery of initial preoperative care. We recommend that other centres assess their performance against this data.

Antibiotic treatment during infancy and increased body mass index in boys: an international cross-sectional study.

OBJECTIVE: To investigate whether antibiotic exposure during the first year of life is associated with increased childhood body mass index (BMI). DESIGN: Secondary analysis from a multi-centre, multi-country, cross-sectional study (The International Study of Asthma and Allergies in Childhood Phase Three). SUBJECTS: A total of 74 946 children from 31 centres in 18 countries contributed data on antibiotic use in the first 12 months of life and current BMI. METHODS: Parents/guardians of children aged 5-8 years completed questionnaires that included questions about their children's current height and weight, and whether in the child's first 12 months of life, they had received any antibiotics, paracetamol, were breastfed or the mother/female guardian smoked cigarettes, and whether the child had wheezed in the past 12 months. A general linear mixed model was used to determine the association of antibiotic exposure with BMI, adjusting for age, sex, centre, BMI measurement type (self-reported or measured), maternal smoking, breastfeeding, paracetamol use, gross national income and current wheeze. RESULTS: There was a significant interaction between sex and early-life antibiotic exposure. Early-life antibiotic exposure was associated with increased childhood BMI in boys (+0.107 kg m(-2), P<0.0001), but not in girls (-0.008 kg m(-2), P=0.75) after controlling for age, centre and BMI measurement type. The association remained in boys (+0.104 kg m(-2), P<0.0007), after adjustment for maternal smoking, breastfeeding, paracetamol use and current wheeze. There was no interaction between age, maternal smoking, breastfeeding, paracetamol use, gross national income and current wheeze in the association between early antibiotic exposure and BMI. CONCLUSIONS: Exposure to antibiotics during the first 12 months of life is associated with a small increase in BMI in boys aged 5-8 years in this large international cross-sectional survey. By inference this provides additional support for the importance of gut microbiota in modulating the risk of obesity, with a sex-specific effect.

Is a lateral view essential in management of hip fracture?

INTRODUCTION: Neck of femur accounts to about 86,000 cases per annum in UK. AP and lateral radiographs form an essential investigation in planning the management of these fractures. Recently it has been suggested that lateral view does not provide any additional information in majority of the cases. MATERIALS AND METHODS: We looked retrospectively at 25 consecutive radiographs with intracapsular and extracapsular fracture neck of femur each presenting to our department between May 2010 and January 2011. These radiographs were put on the CD in 2 folders as AP and lateral. It was reviewed by 2 observers who suggested their preferred treatment. The results were compared for the intra observer agreement to assess the necessity of the lateral view of the radiographs. We also compared the treatment options with the gold standard. RESULTS: Our results showed that lateral view did not make any difference in the management in majority of the cases with excellent agreement based on kappa statistics. CONCLUSION: We feel that the lateral view does not make any difference in most of the cases as shown by a good intraobserver agreement.

Five-year functional outcome analysis of ankle fracture fixation.

This study examines retrospectively the functional outcome of patients at 5 years following their ankle fracture surgery using the Olerud-Molander Ankle Score (OMAS) and SF-12 questionnaire. Of 69 patients, 43 were females and 26 males. The mean age was 50.7 years. There were 74 and 26% of Weber 'B' and 'C' fractures, respectively. The mean OMAS was 75.2. About 63% of the patients were still complaining of stiffness, around 45% patients were still complaining of ankle swelling, 50% of patients still had some sort of pain, 39% still thought that they had not fully recovered and 38% did not return to their pre-injury sporting activity. Apart from the age, no significant difference was seen in the OMAS due to gender, fracture type or timing of surgery. Our findings show that many patients who have had surgery for ankle fractures will still have some functional limitations even 5 years after the injury.

Cognitive ecology: a field of substance?

In 1993, Les Real invented the label 'cognitive ecology'. This label was intended for work that brought cognitive science and behavioural ecology together. Real's article stressed the importance of such an approach to the understanding of behaviour. At the end of a decade in which more interdisciplinary work on behaviour has been seen than for many years, it is time to assess whether cognitive ecology is a label describing an active field.

Anxiety and depression disorders 5 years after severe injuries: a prospective follow-up study.

Individuals with severe injuries were investigated 5 years after the traumatic events, and predictors of anxiety and depression disorders were identified. Trauma victims were selected who had an Injury Severity Score of > or = 16 and were brought to all hospitals in the Mersey region and North Wales over 1 year. The 212 patients aged > or = 15 years who left the hospital alive and lived within an accessible distance of the study hospital in Warrington were contacted 5 years later and 158 (74.5%) received follow-up assessment. Thirty-eight subjects (36.9%) reported "definite" anxiety and/or depression disorders and, of these, only 21.1% reported taking psychotropic medications. Factors associated with anxiety and/or depression disorders at follow-up were: sequelae of head injury (i.e., cognitive problems, posttraumatic seizures, facial pain): writing impairment: disability due to thorax problems; and a new trauma during follow-up. Initial severity or types of injuries and overall residual disability rated by the investigator were not strong predictors of anxiety and/or depression disorders at follow-up.

An analysis of radiating pain at lumbar discography.

This study aimed to identify the morphological abnormalities of the intervertebral disc, as demonstrated by lumbar discography, that are associated with pain radiation to the hip, groin, buttock or lower limb. We carried out a retrospective review of 99 consecutive lumbar discogram reports. The association of disc degeneration, annular tears (partial or full thickness) and the level of disc injected was determined with respect to the presence and pattern of radiating pain. A total of 260 discs were injected, of which 179 were considered abnormal. Posterior annular tears were demonstrated in 84 discs, anterior annular tears in 15 discs and 45 discs had both anterior and posterior tears. A significant association was identified between isolated posterior tears and the production of concordant radiating pain (P = 0.0041). No difference was identified between partial thickness posterior tears and full thickness posterior tears associated with leak of contrast medium, with regard to radiating pain. Similarly, there was no significant association between disc level injected and the pattern of pain radiation. The results indicate that pain experienced in the buttock, hip, groin or lower limb can arise from the posterior annulus of the intervertebral disc without direct involvement of the nerve root.

Vertebral end-plate (Modic) changes on lumbar spine MRI: correlation with pain reproduction at lumbar discography.

The vertebral end-plate has been identified as a possible source of discogenic low back pain. MRI demonstrates end-plate (Modic) changes in 20-50% of patients with low back pain. The aim of this study was to investigate the association between Modic changes on MRI and discogenic back pain on lumbar discography. The MRI studies and discograms of 58 patients with a clinical diagnosis of discogenic back pain were reviewed and the presence of a Modic change was correlated with pain reproduction at 152 disc levels. Twenty-three discs with adjacent Modic changes were injected, 21 of which were associated with pain reproduction. However, pain was also reproduced at 69 levels where no Modic change was seen. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for a Modic change as a marker of a painful disc were 23.3%, 96.8%, 91.3% and 46.5% respectively. Modic changes, therefore, appear to be a relatively specific but insensitive sign of a painful lumbar disc in patients with discogenic low back pain.

Disability after severe injury: five year follow up of a large cohort.

The early outcome for severely injured patients has improved in the last 20 years, but the level of continuing long term disability in such patients is not known. A large cohort of severely injured patients (ISS > 15) were interviewed and examined approximately 5 years following their injury. We present the preliminary results which show that only 30 per cent had made a full recovery, and that an alarming 47 per cent remain with moderate, severe or very severe disabilities. A large proportion (45%) of the persisting disability is due to pelvic and limb injury (74 per cent if brain and spinal cord injuries are excluded). This study reflects initial treatment in 13 District General Hospitals and one Teaching Hospital in a single geographical region in 1989 and 1990, and is the first such study in the UK. We conjecture whether more aggressive and specialized treatment and rehabilitation, especially of orthopaedic injuries, would improve these disappointing results.

The value of lumbar spine magnetic resonance imaging in the demonstration of anular tears.

STUDY DESIGN: Retrospective review of magnetic resonance imaging and discography in patients investigated for low back pain before spinal fusion. OBJECTIVE: To determine the sensitivity of magnetic resonance imaging in the detection of painful anular tears manifested by the high-intensity zone. SUMMARY OF BACKGROUND DATA: Two studies have produced results showing that magnetic resonance imaging has a high specificity for the detection of painful anular tears manifested by a high-intensity zone. However, in a recent study, results showed no significant correlation between the high-intensity zone and pain reproduction. The sensitivity of magnetic resonance imaging in identifying anular tears in a symptomatic population has not been determined. METHODS: Anular tears were identified in magnetic resonance images by the presence of a high-intensity zone in the posterior anulus. The results were compared with the demonstration of painful anular tears on discogram, which has been considered the gold standard. RESULTS: The study group comprised 58 patients (31 men, 27 women; mean age 42, range 21-63 years). One hundred and fifty-two discs were injected and examined by discography, and 108 were considered degenerate. Of these, 86 had anular tears (54 posterior, 6 anterior, 26 both). Seventy anular tears were associated with concordant pain provocation. Twenty-seven high-intensity zones were identified in magnetic resonance imaging, of which 24 were associated with pain reproduction by discography. The sensitivity, specificity, positive predictive value, and negative predictive value of magnetic resonance imaging in the diagnosis of concordantly painful posterior anular tears are therefore 26.7%, 95.2%, 88.9%, and 47%, respectively. CONCLUSION: These results confirm that the high-intensity zone is a marker of a painful posterior anular tear. However, the usefulness of this sign is limited by low sensitivity.

An investigation into the effect of ischaemia and pressure on irritant inflammation.

Reports of chemical burns beneath tourniquets during orthopaedic procedures led us to explore the irritant effects produced by the skin antiseptics used during such procedures. A sphygmomanometer and tourniquet, at a pressure of 200 mmHg for 30 min, was used to created pressure and ischaemia which were then examined separately for their respective effects on irritant inflammation in normal subjects and those with atopic eczema. As no inflammation could be demonstrated with the antiseptics, we subsequently used the known irritant chemical anthralin to examine the effect of ischaemia with and without pressure. Site-related variation in anthralin-induced inflammation was observed but there was no demonstrable effect of either pressure or ischaemia on the inflammatory response. Therefore, as we are unable to show a relationship between ischaemia with or without pressure and irritant inflammation, we conclude that burns under tourniquets are likely to be idiosyncratic reactions and their further investigation requires examination of the individuals affected.