David J. McLernon

Validating the Readiness for Interprofessional Learning Scale (RIPLS) in the postgraduate context: are health care professionals ready for IPL?

Aims  This paper describes the process of validating the Readiness for Interprofessional Learning Scale (RIPLS) for use with postgraduate health care professionals.

Adverse drug reaction reporting in the UK: a retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals.

AbstractBackground: In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports. Objective: To compare patient characteristics, suspected drugs and suspected ADRs reported by patients with those reported by healthcare professionals using the YCS. Design and Setting: Retrospective observational study in the UK. Methods: Participants were patients reported to the Medicines and Healthcare products Regulatory Agency (MHRA), either by themselves, a representative or a healthcare professional, as having one or more suspected ADRs between October 2005 and September 2007. The main outcome measures were ADRs and time taken to report. Results: In total, 26 129 Yellow Card reports from patients and healthcare professionals were received from the MHRA for the 2-year study period (19.8% patient and 80.2% healthcare professional). More Yellow Card reports were made for female than male patients (p < 0.001). Patients reported a significantly higher number of suspected ADRs per report than healthcare professionals (median [interquartile range IQR] of 3 [2–5] vs 2 [1–3], respectively; p<0.001). A higher proportion of patient reports (16.1%) contained more than one suspect drug than healthcare professional reports (9%; p < 0.001). Healthcare professional reports had a higher proportion of ADRs that caused hospitalization (18.8% vs 12.9%), were life threatening (11.1% vs 6.2%) or caused death (2.6% vs 0.7%) than patient reports (all p<0.001). Patient reporters took a significantly longer time to report their reaction than healthcare professionals (median [IQR] of 104 [27–463] vs 28 [13–75] days respectively; p<0.001). Direct comparisons of the seriousness of the ADRs were not possible because of important differences between patient and healthcare professional versions of the Yellow Cards. Conclusions: This is the first substantial, published study in the UK to compare Yellow Card reports from patients and healthcare professionals. Whilst patients report more suspected ADRs to more suspect drugs than healthcare professionals, healthcare professionals tend to report more serious reactions that result in hospitalization, are life threatening or cause death. Further research is required to investigate the extent to which the extra information from patient reporters contributes to signal identification when assessing drug safety.

Planned Cesarean Delivery at Term and Adverse Outcomes in Childhood Health

IMPORTANCE Planned cesarean delivery comprises a significant proportion of births globally, with combined rates of planned and unscheduled cesarean delivery in a number of regions approaching 50%. Observational studies have shown that offspring born by cesarean delivery are at increased risk of ill health in childhood, but these studies have been unable to adjust for some key confounding variables. Additionally, risk of death beyond the neonatal period has not yet been reported for offspring born by planned cesarean delivery. OBJECTIVE To investigate the relationship between planned cesarean delivery and offspring health problems or death in childhood. DESIGN, SETTING, AND PARTICIPANTS Population-based data-linkage study of 321,287 term singleton first-born offspring born in Scotland, United Kingdom, between 1993 and 2007, with follow-up until February 2015. EXPOSURES Offspring born by planned cesarean delivery in a first pregnancy were compared with offspring born by unscheduled cesarean delivery and with offspring delivered vaginally. MAIN OUTCOMES AND MEASURES The primary outcome was asthma requiring hospital admission; secondary outcomes were salbutamol inhaler prescription at age 5 years, obesity at age 5 years, inflammatory bowel disease, type 1 diabetes, cancer, and death. RESULTS Compared with offspring born by unscheduled cesarean delivery (n = 56,015 [17.4%]), those born by planned cesarean delivery (12,355 [3.8%]) were at no significantly different risk of asthma requiring hospital admission, salbutamol inhaler prescription at age 5 years, obesity at age 5 years, inflammatory bowel disease, cancer, or death but were at increased risk of type 1 diabetes (0.66% vs 0.44%; difference, 0.22% [95% CI, 0.13%-0.31%]; adjusted hazard ratio [HR], 1.35 [95% CI, 1.05-1.75]). In comparison with children born vaginally (n = 252,917 [78.7%]), offspring born by planned cesarean delivery were at increased risk of asthma requiring hospital admission (3.73% vs 3.41%; difference, 0.32% [95% CI, 0.21%-0.42%]; adjusted HR, 1.22 [95% CI, 1.11-1.34]), salbutamol inhaler prescription at age 5 years (10.34% vs 9.62%; difference, 0.72% [95% CI, 0.36%-1.07%]; adjusted HR, 1.13 [95% CI, 1.01-1.26]), and death (0.40% vs 0.32%; difference, 0.08% [95% CI, 0.02%-1.00%]; adjusted HR, 1.41 [95% CI, 1.05-1.90]), whereas there were no significant differences in risk of obesity at age 5 years, inflammatory bowel disease, type 1 diabetes, or cancer. CONCLUSIONS AND RELEVANCE Among offspring of women with first births in Scotland between 1993 and 2007, planned cesarean delivery compared with vaginal delivery (but not compared with unscheduled cesarean delivery) was associated with a small absolute increased risk of asthma requiring hospital admission, salbutamol inhaler prescription at age 5 years, and all-cause death by age 21 years. Further investigation is needed to understand whether the observed associations are causal.

Minimising twins in in vitro fertilisation: a modelling study assessing the costs, consequences and cost–utility of elective single versus double embryo transfer over a 20‐year time horizon

Please cite this paper as: Scotland G, McLernon D, Kurinczuk J, McNamee P, Harrild K, Lyall H, Rajkhowa M, Hamilton M, Bhattacharya S. Minimising twins in in vitro fertilisation: a modelling study assessing the costs, consequences and cost–utility of elective single versus double embryo transfer over a 20‐year time horizon. BJOG 2011;118:1073–1083.

Cumulative live birth rate: time for a consensus?

Traditionally, IVF success rates have been reported in terms of live birth per fresh cycle or embryo transfer. With the increasing use of embryo freezing and thawing it is essential that we report not only outcomes following fresh but also those after frozen embryo transfer as a complete measure of success of an IVF treatment. Most people agree that an individuals chance of having a baby following fresh and frozen embryo transfer should be described as cumulative live birth rate. However, views on the most appropriate parameters required to calculate such an outcome have been inconsistent. There is an additional dimension-time for all frozen embryos to be used up by a couple, which can influence the outcome. Given that cumulative live birth rate is generally perceived to be the preferred reporting system in IVF, it is time to have an international consensus on how this statistic is calculated, reported and interpreted by stakeholders across the world.

Five year prognosis in patients with angina identified in primary care: incident cohort study.

Objective To ascertain the risk of acute myocardial infarction, invasive cardiac procedures, and mortality among patients with newly diagnosed angina over five years. Design Incident cohort study of patients with primary care data linked to secondary care and mortality data. Setting 40 primary care practices in Scotland. Participants 1785 patients with a diagnosis of angina as their first manifestation of ischaemic heart disease, 1 January 1998 to 31 December 2001. Main outcome measures Adjusted hazard ratios for acute myocardial infarction, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, death from ischaemic heart disease, and all cause mortality, adjusted for demographics, lifestyle risk factors, and comorbidity at cohort entry. Results Mean age was 62.3 (SD 11.3). Male sex was associated with an increased risk of acute myocardial infarction (hazard ratio 2.01, 95% confidence interval 1.35 to 2.97), death from ischaemic heart disease (2.80, 1.73 to 4.53), and all cause mortality (1.82, 1.33 to 2.49). Increasing age was associated with acute myocardial infarction (1.04, 1.02 to 1.06, per year of age increase), death from ischaemic heart disease (1.09, 1.06 to 1.11, per year of age increase), and all cause mortality (1.09, 1.07 to 1.11, per year of age increase). Smoking was associated with subsequent acute myocardial infarction (1.94, 1.31 to 2.89), death from ischaemic heart disease (2.12, 1.32 to 3.39), and all cause mortality (2.11, 1.52 to 2.95). Obesity was associated with death from ischaemic heart disease (2.01, 1.17 to 3.45) and all cause mortality (2.20, 1.52 to 3.19). Previous stroke was associated with all cause mortality (1.78, 1.13 to 2.80) and chronic kidney disease with death from ischaemic heart disease (5.72, 1.74 to 18.79). Men were more likely than women to have coronary artery bypass grafting or percutaneous transluminal coronary angioplasty after a diagnosis of angina; older people were less likely to receive percutaneous transluminal coronary angioplasty. Acute myocardial infarction after a diagnosis of angina was associated with an increased risk of death from ischaemic heart disease and all cause mortality (8.84 (5.31 to 14.71) and 4.23 (2.78 to 6.43), respectively). Neither of the invasive cardiac procedures significantly reduced the subsequent risk of all cause mortality. Conclusions In this sample of people with incident angina from primary care, there were sex differences in survival and age and sex differences in the provision of revascularisation after a diagnosis. Acute myocardial infarction after a diagnosis of angina was strongly predictive of mortality. To minimise adverse outcomes, optimal preventive treatments should be used in patients with angina.

Development of a decision support tool for primary care management of patients with abnormal liver function tests without clinically apparent liver disease: a record-linkage population cohort study and decision analysis (ALFIE)

OBJECTIVES To determine the natural history of abnormalities in liver function tests (LFTs), derive predictive algorithms for liver disease and identify the most cost-effective strategies for further investigation. DATA SOURCES MEDLINE database from 1966 to September 2006, EMBASE, CINAHL and the Cochrane Library. METHODS Population-based retrospective cohort study set in primary care in Tayside, Scotland, between 1989 and 2003. Participants were patients with no obvious signs of liver disease and registered with a general practitioner (GP). The study followed up those with an incident batch of LFTs in primary care to subsequent liver disease or mortality over a maximum of 15 years. The health technologies being assessed were primary care LFTs, viral and autoantibody tests, ultrasound and liver biopsy. Measures used were the epidemiology of liver disease in Tayside (ELDIT) database, time-to-event modelling, predictive algorithms derived using the Weibull survival model, decision analyses from an NHS perspective, cost-utility analyses, and one-way and two-way sensitivity analyses. RESULTS A total of 95,977 patients had 364,194 initial LFTs, with a median follow-up of 3.7 years. Of these, 21.7% had at least one abnormal liver function test (ALFT) and 1090 (1.14%) developed liver disease. Elevated transaminases were strongly associated with diagnosed liver disease, with hazard ratios (HRs) of 4.23 [95% CI (confidence interval) 3.55-5.04] for mild levels and 12.67 (95% CI 9.74-16.47) for severe levels versus normal. For gamma-glutamyltransferase (GGT), these HRs were 2.54 (95% CI 2.17-2.96) and 13.44 (10.71-16.87) respectively. Low albumin was strongly associated with all cause mortality, with ratios of 2.65 (95% CI 2.47-2.85) for mild levels and 4.99 (95% CI 4.26-5.84) for severe levels. Sensitivity for predicting events over 5 years was low and specificity was high. Follow-up time was split into baseline to 3 months, 3 months to 1 year and over 1 year. All LFTs were predictive of liver disease, and high probability of liver disease was associated with being female, methadone use, alcohol dependency and deprivation. The shorter-term models had overall c-statistics of 0.85 and 0.72 for outcome of liver disease at 3 months and 1 year respectively, and 0.88 and 0.82 for all cause mortality at 3 months and 1 year respectively. Calibration was good for models predicting liver disease. Discrimination was low for models predicting events at over 1 year. In cost-utility analyses, retesting dominated referral as an option. However, using the predictive algorithms to identify the top percentile at high risk of liver disease, retesting had an incremental cost-utility ratio of 7588 pounds relative to referral. CONCLUSIONS GGT should be included in the batch of LFTs in primary care. If the patient in primary care has no obvious liver disease and a low or moderate risk of liver disease, retesting in primary care is the most cost-effective option. If the patient with ALFTs in primary care has a high risk of liver disease, retesting depends on the willingness to pay of the NHS. Cut-offs are arbitrary and in developing decision aids it is important to treat the LFT results as continuous variables.

Patient views and experiences of making adverse drug reaction reports to the Yellow Card Scheme in the UK

To describe the characteristics of patient reporters to the UKs Yellow Card Scheme (YCS) and the suspect drugs reported, and to determine patient views and experiences of making a Yellow Card report.

Five-Year Prognosis in an Incident Cohort of People Presenting with Acute Myocardial Infarction

Background Following an AMI, it is important for patients and their physicians to appreciate the subsequent risk of death, and the potential benefits of invasive cardiac procedures and secondary preventive therapy. Studies, to-date, have focused largely on high-risk populations. We wished to determine the risk of death in a population-derived cohort of 2,887 patients after a first acute myocardial infarction (AMI). Methods Logistic regression and survival analysis were conducted to investigate the effect of different baseline characteristics, pharmacological therapies and revascularization procedures on coronary heart disease (CHD) and all-cause mortality outcomes. Results Within five years 44.4% of patients died (27.1% short-term [<30 days] and 23.7% longer-term [≥30 days]). Percutaneous transluminal coronary angioplasty (Adjusted Hazards Ratio (AHR) = 0.49, 95% Confidence Interval (CI) 0.26–0.93), β-blockers (AHR = 0.58, 95%CI 0.46–0.74) and statins (AHR = 0.60, 95%CI 0.47–0.77) were all associated with significant reductions in longer-term CHD-related mortality. However, not all patients received secondary preventive therapy (8.7%). Diabetes (AHR = 1.83, 95%CI 1.43–2.34), stroke (AHR = 1.73, 95%CI 1.35–2.22), heart failure (AHR = 1.69, 95%CI 1.28–2.22), smoking (AHR = 1.72, 95%CI 1.18–2.51) and obesity (>30 kg/m2; AHR = 1.39, 95%CI 1.01–1.90) increased the risk of longer-term mortality independent of other risk factors. Conclusions It is encouraging that the coronary procedure PTCA and pharmacological secondary prevention therapies were found to be strongly associated with an important reduced risk of subsequent death, although not all patients received these interventions. Smoking, being obese and having cardiovascular related disease at baseline were also associated with an increased likelihood of longer-term mortality, independent of other baseline characteristics. Thus, the provision of smoking cessation, advice on diet (for obese patients) and optimal treatment is likely to be crucial for reducing mortality in all patients after AMI.

Do lifestyle choices explain the effect of alcohol on bone mineral density in women around menopause

BACKGROUND Moderate alcohol consumption has been shown to be positively associated with increased bone mineral density (BMD). However, other lifestyle choices have also been shown to have an effect on bone health. OBJECTIVE The objective was to examine the association between alcohol intake and BMD in women around menopause in the United Kingdom and to determine whether any association is independent of other lifestyle choices. DESIGN A cross-sectional study design was used to examine the relation between alcohol intake and BMD in a cohort of 3218 women aged 50-62 y from the Aberdeen Prospective Osteoporosis Screening Study. Women were grouped into clusters according to their lifestyle choices. ANCOVA was used to examine the effect of categorized alcohol intake on BMD adjusted for cluster of lifestyle and other baseline covariates. The ANCOVA was repeated for different types of alcoholic beverage (eg, beer, liquor, and wine) separately. RESULTS Three lifestyle clusters were identified and were based on different levels of the following 3 factors: smoking pack-years, fruit and vegetable intakes, and physical activity. In the lifestyle-adjusted models, women who consumed >1 drink/d of alcohol had a significantly greater femoral neck BMD (P = 0.008) and lumbar spine BMD (P = 0.007) than did those who never consumed alcohol. For separate alcoholic drinks, only beer had a positive significant effect on lumbar spine BMD after adjustment for lifestyle (P = 0.005). CONCLUSION Moderate alcohol intake appears to be positively associated with BMD independently of the type of lifestyle led by women around menopause.