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3.  Bad apples or spoiled barrels? Multilevel modelling analysis of variation in high-risk prescribing in Scotland between general practitioners and between the practices they work in 
BMJ Open  2015;5(11):e008270.
Primary care high-risk prescribing causes significant harm, but it is unclear if it is largely driven by individuals (a ‘bad apple’ problem) or by practices having higher or lower risk prescribing cultures (a ‘spoiled barrel’ problem). The study aimed to examine the extent of variation in high-risk prescribing between individual prescribers and between the practices they work in.
Design, setting and participants
Multilevel logistic regression modelling of routine cross-sectional data from 38 Scottish general practices for 181 010 encounters between 398 general practitioners (GPs) and 26 539 patients particularly vulnerable to adverse drug events (ADEs) of non-steroidal anti-inflammatory drugs (NSAIDs) due to age, comorbidity or co-prescribing.
Outcome measure
Initiation of a new NSAID prescription in an encounter between GPs and eligible patients.
A new high-risk NSAID was initiated in 1953 encounters (1.1% of encounters, 7.4% of patients). Older patients, those with more vulnerabilities to NSAID ADEs and those with polypharmacy were less likely to have a high-risk NSAID initiated, consistent with GPs generally recognising the risk of NSAIDs in eligible patients. Male GPs were more likely to initiate a high-risk NSAID than female GPs (OR 1.73, 95% CI 1.39 to 2.16). After accounting for patient characteristics, 4.2% (95% CI 2.1 to 8.3) of the variation in high-risk NSAID prescribing was attributable to variation between practices, and 14.2% (95% CI 11.4 to 17.3) to variation between GPs. Three practices had statistically higher than average high-risk prescribing, but only 15.7% of GPs with higher than average high-risk prescribing and 18.5% of patients receiving such a prescription were in these practices.
There was much more variation in high-risk prescribing between GPs than between practices, and only targeting practices with higher than average rates will miss most high-risk NSAID prescribing. Primary care prescribing safety improvement should ideally target all practices, but encourage practices to consider and act on variation between prescribers in the practice.
PMCID: PMC4636636  PMID: 26546137
4.  A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial 
Lancet (London, England)  2014;383(9924):1211-1221.
The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans.
We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35–65 years with a body-mass index (BMI) of 28 kg/m2 or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2–9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491.
374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95–5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64–5·08), both in favour of the intervention (p<0·0001). Eight serious adverse events were reported, five in the intervention group (lost consciousness due to drugs for pre-existing angina, gallbladder removal, hospital admission with suspected heart attack, ruptured gut, and ruptured Achilles tendon) and three in the comparison group (transient ischaemic attack, and two deaths). Of these, two adverse events were reported as related to participation in the programme (gallbladder removal and ruptured Achilles tendon).
The FFIT programme can help a large proportion of men to lose a clinically important amount of weight; it offers one effective strategy to challenge male obesity.
PMCID: PMC4524002  PMID: 24457205
5.  Feasibility study of the effects of art as a creative engagement intervention during stroke rehabilitation on improvement of psychosocial outcomes: study protocol for a single blind randomized controlled trial: the ACES study 
Trials  2014;15:380.
Benefits of art participation after stroke are becoming increasingly recognized. Qualitative studies suggest that participation in visual arts creative engagement interventions (CEIs) during rehabilitation after stroke may improve mood, self-esteem, hope and some aspects of physical recovery. This study examines the feasibility of undertaking a randomized controlled trial of a CEI delivered by artists within in-patient stroke rehabilitation to test effectiveness.
This trial is a two arm, single-blind, randomized controlled feasibility trial within in-patient stroke rehabilitation. We will recruit 80 patients receiving stroke rehabilitation in two stroke units in a health board area of Scotland (40 patients in each arm). Intervention arm participants will receive a visual-arts based CEI facilitated by experienced artists. Artists will follow an intervention protocol with specific components that enable participants to set, achieve and review artistic goals. Participants will receive up to eight intervention sessions, four within a group and four one-to-one with the artist. Control group participants will receive usual care only.
Data collection will occur at baseline, post-intervention and three-month follow-up. Stroke-related health status is the primary outcome; mood, self-esteem, self-efficacy, perceived recovery control and hope are secondary outcomes. Semi-structured interviews will be conducted with purposively selected patients, artists and healthcare staff to elicit views and experiences of the intervention and feasibility and acceptability of trial processes. Recruitment rates, retention rates and patient preference for art participation will also be collected. Data will indicate, with confidence intervals, the proportion of patients choosing or refusing participation in the CEI and will allow calculation of recruitment rates for a future definitive trial. Summary data will indicate potential variability, magnitude and direction of difference between groups. Findings will inform sample size calculations for a definitive trial. Thematic analysis of qualitative data will be managed using the Framework Approach. Framework is an analytical approach for qualitative data, commonly used in policy and medical research.
If shown to demonstrate effects, this intervention has the potential to address aspects of stroke recovery previously. Not routinely addressed in rehabilitation.
Trial registration
Registered with Clinical Trials.Gov: NCT02085226 on 6th March 2014.
Electronic supplementary material
The online version of this article (doi:10.1186/1745-6215-15-380) contains supplementary material, which is available to authorized users.
PMCID: PMC4190489  PMID: 25262168
Stroke; Art; Mood; Self-esteem; Health status
6.  Prediction of liver disease in patients whose liver function tests have been checked in primary care: model development and validation using population-based observational cohorts 
BMJ Open  2014;4(6):e004837.
To derive and validate a clinical prediction model to estimate the risk of liver disease diagnosis following liver function tests (LFTs) and to convert the model to a simplified scoring tool for use in primary care.
Population-based observational cohort study of patients in Tayside Scotland identified as having their LFTs performed in primary care and followed for 2 years. Biochemistry data were linked to secondary care, prescriptions and mortality data to ascertain baseline characteristics of the derivation cohort. A separate validation cohort was obtained from 19 general practices across the rest of Scotland to externally validate the final model.
Primary care, Tayside, Scotland.
Derivation cohort: LFT results from 310 511 patients. After exclusions (including: patients under 16 years, patients having initial LFTs measured in secondary care, bilirubin >35 μmol/L, liver complications within 6 weeks and history of a liver condition), the derivation cohort contained 95 977 patients with no clinically apparent liver condition. Validation cohort: after exclusions, this cohort contained 11 653 patients.
Primary and secondary outcome measures
Diagnosis of a liver condition within 2 years.
From the derivation cohort (n=95 977), 481 (0.5%) were diagnosed with a liver disease. The model showed good discrimination (C-statistic=0.78). Given the low prevalence of liver disease, the negative predictive values were high. Positive predictive values were low but rose to 20–30% for high-risk patients.
This study successfully developed and validated a clinical prediction model and subsequent scoring tool, the Algorithm for Liver Function Investigations (ALFI), which can predict liver disease risk in patients with no clinically obvious liver disease who had their initial LFTs taken in primary care. ALFI can help general practitioners focus referral on a small subset of patients with higher predicted risk while continuing to address modifiable liver disease risk factors in those at lower risk.
PMCID: PMC4054629  PMID: 24889852
7.  Association of Day Length and Weather Conditions with Physical Activity Levels in Older Community Dwelling People 
PLoS ONE  2014;9(1):e85331.
Weather is a potentially important determinant of physical activity. Little work has been done examining the relationship between weather and physical activity, and potential modifiers of any relationship in older people. We therefore examined the relationship between weather and physical activity in a cohort of older community-dwelling people.
We analysed prospectively collected cross-sectional activity data from community-dwelling people aged 65 and over in the Physical Activity Cohort Scotland. We correlated seven day triaxial accelerometry data with daily weather data (temperature, day length, sunshine, snow, rain), and a series of potential effect modifiers were tested in mixed models: environmental variables (urban vs rural dwelling, percentage of green space), psychological variables (anxiety, depression, perceived behavioural control), social variables (number of close contacts) and health status measured using the SF-36 questionnaire.
547 participants, mean age 78.5 years, were included in this analysis. Higher minimum daily temperature and longer day length were associated with higher activity levels; these associations remained robust to adjustment for other significant associates of activity: age, perceived behavioural control, number of social contacts and physical function. Of the potential effect modifier variables, only urban vs rural dwelling and the SF-36 measure of social functioning enhanced the association between day length and activity; no variable modified the association between minimum temperature and activity.
In older community dwelling people, minimum temperature and day length were associated with objectively measured activity. There was little evidence for moderation of these associations through potentially modifiable health, environmental, social or psychological variables.
PMCID: PMC3907400  PMID: 24497925
10.  Goal-setting intervention in patients with active asthma: protocol for a pilot cluster-randomised controlled trial 
Trials  2013;14:289.
Supporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation.
A two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff.
Trial registration
PMCID: PMC3846716  PMID: 24021033
Asthma; Goals; Behaviour change; Intervention; RCT; Primary care
11.  Psychological theory in an interdisciplinary context: psychological, demographic, health-related, social, and environmental correlates of physical activity in a representative cohort of community-dwelling older adults 
Physical activity (PA) in older adults is influenced by a range of environmental, demographic, health-related, social, and psychological variables. Social cognitive psychological models assume that all influences on behaviour operate indirectly through the models constructs, i.e., via intention and self-efficacy. We evaluated direct, indirect, and moderating relationships of a broad range of external variables with physical activity levels alongside intention and self-efficacy.
We performed a cross-sectional survey of a representative and stratified (65–80 and 80+ years; deprived and affluent) sample of 584 community-dwelling people, resident in Scotland. Objectively measured physical activity and questionnaire data were collected.
Self-efficacy showed unique relationships with physical activity, controlling for demographic, mental health, social, environmental, and weather variables separately, but the relationship was not significant when controlling for physical health. Overall, results indicating support for a mediation hypothesis, intention and self-efficacy statistically mediate the relationship of most domain variables with physical activity. Moderation analyses show that the relationship between social cognitions and physical activity was stronger for individuals with better physical health and lower levels of socio-economic deprivation.
Social cognitive variables reflect a range of known environmental, demographic, health-related and social correlates of physical activity, they mediate the relationships of those correlates with physical activity and account for additional variance in physical activity when external correlates are controlled for, except for the physical health domain. The finding that the social cognition-physical activity relationship is higher for participants with better health and higher levels of affluence raises issues for the applicability of social cognitive models to the most disadvantaged older people.
PMCID: PMC3847689  PMID: 24011129
Physical activity; Older adults; Social ecological model
12.  Evaluating the reliability, validity, acceptability, and practicality of SMS text messaging as a tool to collect research data: results from the Feeding Your Baby project 
To test the reliability, validity, acceptability, and practicality of short message service (SMS) messaging for collection of research data.
Materials and methods
The studies were carried out in a cohort of recently delivered women in Tayside, Scotland, UK, who were asked about their current infant feeding method and future feeding plans. Reliability was assessed by comparison of their responses to two SMS messages sent 1 day apart. Validity was assessed by comparison of their responses to text questions and the same question administered by phone 1 day later, by comparison with the same data collected from other sources, and by correlation with other related measures. Acceptability was evaluated using quantitative and qualitative questions, and practicality by analysis of a researcher log.
Reliability of the factual SMS message gave perfect agreement. Reliabilities for the numerical question were reasonable, with κ between 0.76 (95% CI 0.56 to 0.96) and 0.80 (95% CI 0.59 to 1.00). Validity for data compared with that collected by phone within 24 h (κ =0.92 (95% CI 0.84 to 1.00)) and with health visitor data (κ =0.85 (95% CI 0.73 to 0.97)) was excellent. Correlation validity between the text responses and other related demographic and clinical measures was as expected. Participants found the method a convenient and acceptable way of providing data. For researchers, SMS text messaging provided an easy and functional method of gathering a large volume of data.
In this sample and for these questions, SMS was a reliable and valid method for capturing research data.
PMCID: PMC3422836  PMID: 22539081
Cellular phone; SMS text messaging; reproducibility of results; data collection; method acceptability; midwifery; feeding your baby study; psychology
13.  Prediction of initiation and cessation of breastfeeding from late pregnancy to 16 weeks: the Feeding Your Baby (FYB) cohort study 
BMJ Open  2013;3(8):e003274.
To derive prediction models for both initiation and cessation of breastfeeding using demographic, psychological and obstetric variables.
A prospective cohort study.
Women delivering at Ninewells Hospital, Dundee, UK.
Data sources
Demographic data and psychological measures were obtained during pregnancy by questionnaire. Birth details, feeding method at birth and at hospital discharge were obtained from the Ninewells hospital database, Dundee, UK. Breastfeeding women were followed up by text messages every 2 weeks until 16 weeks or until breastfeeding was discontinued to ascertain feeding method and feeding intentions.
Pregnant women over 30 weeks gestation aged 16 years and above, living in Dundee, booked to deliver at Ninewells Hospital, Dundee, and able to speak English.
Main outcome measure
Initiation and cessation of breastfeeding.
From the total cohort of women at delivery (n=344) 68% (95% CI 63% to 73%) of women had started breastfeeding at discharge. Significant predictors of initiating breastfeeding were older age, parity, greater intention to breastfeed from a Theory of Planned Behaviour (TPB)-based questionnaire, higher Iowa Infant Feeding Assessment Scale (IIFAS) score as well as living with a husband or partner. For the final model, the AUROC was 0.967. For those who initiated breastfeeding (n=233), the strongest predictors of stopping were low intention to breastfeed from TPB, low IIFAS score and non-managerial/professional occupations.
The findings from this study will be used to inform the protocol for an intervention study to encourage and support prolonged breastfeeding as intentions appear to be a key intervention focus for initiation. The predictive models could be used to identify women at high risk of not initiating and also women at high risk of stopping for interventions to improve the longevity of breastfeeding.
PMCID: PMC3733309  PMID: 23906958
Public Health; Nutrition & Dietetics
14.  Impact of clinical trial findings on Bell's palsy management in general practice in the UK 2001–2012: interrupted time series regression analysis 
BMJ Open  2013;3(7):e003121.
To measure the incidence of Bell's palsy and determine the impact of clinical trial findings on Bell's palsy management in the UK.
Interrupted time series regression analysis and incidence measures.
General practices in the UK contributing to the Clinical Practice Research Datalink (CPRD).
Patients ≥16 years with a diagnosis of Bell's palsy between 2001 and 2012.
(1) Publication of the 2004 Cochrane reviews of clinical trials on corticosteroids and antivirals for Bell's palsy, which made no clear recommendation on their use and (2) publication of the 2007 Scottish Bell's Palsy Study (SBPS), which made a clear recommendation that treatment with prednisolone alone improves chances for complete recovery.
Main outcome measures
Incidence of Bell's palsy per 100 000 person-years. Changes in the management of Bell's palsy with either prednisolone therapy, antiviral therapy, combination therapy (prednisolone with antiviral therapy) or untreated cases.
During the 12-year period, 14 460 cases of Bell's palsy were identified with an overall incidence of 37.7/100 000 person-years. The 2004 Cochrane reviews were associated with immediate falls in prednisolone therapy (−6.3% (−11.0 to −1.6)), rising trends in combination therapy (1.1% per quarter (0.5 to 1.7)) and falling trends for untreated cases (−0.8% per quarter (−1.4 to −0.3)). SBPS was associated with immediate increases in prednisolone therapy (5.1% (0.9 to 9.3)) and rising trends in prednisolone therapy (0.7% per quarter (0.4 to 1.2)); falling trends in combination therapy (−1.7% per quarter (−2.2 to −1.3)); and rising trends for untreated cases (1.2% per quarter (0.8 to 1.6)). Despite improvements, 44% still remain untreated.
SBPS was clearly associated with change in management, but a significant proportion of patients failed to receive effective treatment, which cannot be fully explained. Clarity and uncertainty in clinical trial recommendations may change clinical practice. However, better ways are needed to understand and circumvent barriers in implementing clinical trial findings.
PMCID: PMC3717449  PMID: 23864211
Epidemiology; Primary Care; Clinical trials < Therapeutics
15.  Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose 
Trials  2013;14:115.
If you want to know which of two or more healthcare interventions is most effective, the randomised controlled trial is the design of choice. Randomisation, however, does not itself promote the applicability of the results to situations other than the one in which the trial was done. A tool published in 2009, PRECIS (PRagmatic Explanatory Continuum Indicator Summaries) aimed to help trialists design trials that produced results matched to the aim of the trial, be that supporting clinical decision-making, or increasing knowledge of how an intervention works. Though generally positive, groups evaluating the tool have also found weaknesses, mainly that its inter-rater reliability is not clear, that it needs a scoring system and that some new domains might be needed. The aim of the study is to: Produce an improved and validated version of the PRECIS tool. Use this tool to compare the internal validity of, and effect estimates from, a set of explanatory and pragmatic trials matched by intervention.
The study has four phases. Phase 1 involves brainstorming and a two-round Delphi survey of authors who cited PRECIS. In Phase 2, the Delphi results will then be discussed and alternative versions of PRECIS-2 developed and user-tested by experienced trialists. Phase 3 will evaluate the validity and reliability of the most promising PRECIS-2 candidate using a sample of 15 to 20 trials rated by 15 international trialists. We will assess inter-rater reliability, and raters’ subjective global ratings of pragmatism compared to PRECIS-2 to assess convergent and face validity. Phase 4, to determine if pragmatic trials sacrifice internal validity in order to achieve applicability, will compare the internal validity and effect estimates of matched explanatory and pragmatic trials of the same intervention, condition and participants. Effect sizes for the trials will then be compared in a meta-regression. The Cochrane Risk of Bias scores will be compared with the PRECIS-2 scores of pragmatism.
We have concrete suggestions for improving PRECIS and a growing list of enthusiastic individuals interested in contributing to this work. By early 2014 we expect to have a validated PRECIS-2.
PMCID: PMC3748822  PMID: 23782862
Pragmatic; Explanatory; Clinical trials; Trial design; Applicability
16.  The Utility of Liver Function Tests for Mortality Prediction within One Year in Primary Care Using the Algorithm for Liver Function Investigations (ALFI) 
PLoS ONE  2012;7(12):e50965.
Although liver function tests (LFTs) are routinely measured in primary care, raised levels in patients with no obvious liver disease may trigger a range of subsequent expensive and unnecessary management plans. The aim of this study was to develop and validate a prediction model to guide decision-making by general practitioners, which estimates risk of one year all-cause mortality in patients with no obvious liver disease.
In this population-based historical cohort study, biochemistry data from patients in Tayside, Scotland, with LFTs performed in primary care were record-linked to secondary care and prescription databases to ascertain baseline characteristics, and to mortality data. Using this derivation cohort a survival model was developed to predict mortality. The model was assessed for calibration, discrimination (using the C-statistic) and performance, and validated using a separate cohort of Scottish primary care practices.
From the derivation cohort (n = 95 977), 2.7% died within one year. Predictors of mortality included: age; male gender; social deprivation; history of cancer, renal disease, stroke, ischaemic heart disease or respiratory disease; statin use; and LFTs (albumin, transaminase, alkaline phosphatase, bilirubin, and gamma-glutamyltransferase). The C-statistic for the final model was 0.82 (95% CI 0.80–0.84), and was similar in the validation cohort (n = 11 653) 0.86 (0.79–0.90). As an example of performance, for a 10% predicted probability cut-off, sensitivity = 52.8%, specificity = 94.0%, PPV = 21.0%, NPV = 98.5%. For the model without LFTs the respective values were 43.8%, 92.8%, 15.6%, 98.1%.
The Algorithm for Liver Function Investigations (ALFI) is the first model to successfully estimate the probability of all-cause mortality in patients with no apparent liver disease having LFTs in primary care. While LFTs added to the model's discrimination and sensitivity, the clinical utility of ALFI remains to be established since LFTs did not improve an already high NPV for short term mortality and only modestly improved a very low PPV.
PMCID: PMC3522690  PMID: 23272082
17.  Identifying suspected breast cancer: development and validation of a clinical prediction rule 
The British Journal of General Practice  2011;61(586):e205-e214.
An evidence-based approach is needed to identify women with breast symptoms who are most likely to have breast cancer so that timely and appropriate referral can take place.
To report the development and validation of a clinical prediction rule for the diagnosis of breast cancer.
Design and setting
Cohort study with two prospective groups of women: those presenting to a symptomatic breast clinic (derivation cohort) and a separate cohort presenting to 11 general practices (validation cohort) in Tayside, Scotland.
Regression analysis was used to derive a clinical prediction rule from presenting symptoms, personal and family history, and clinical findings. Validation consisted of estimating the number of breast cancers predicted to occur compared with the actual number of observed breast cancers across deciles of risk.
In the derivation cohort of 802 patients, 59 (7%) were diagnosed with breast cancer. Independent clinical predictors for breast cancer were: increasing age by year (adjusted odds ratio [AOR] 1.10, 95% confidence interval [CI] = 1.07 to 1.13); presence of a discrete lump (AOR 15.20, 95% CI = 4.88 to 47.34); breast thickening (AOR 7.64, 95% CI = 2.23 to 26.11); lymphadenopathy (AOR 3.63, 95% CI = 1.33 to 9.92); and lump ≥2 cm (AOR 5.41, 95% CI = 2.36 to 12.38). All eight patients with skin tethering had breast cancer. The regression model had good predictive power, identifying all five breast cancers in the validation cohort of 97 patients in the top two deciles of risk.
The clinical prediction rule discriminates between patients at high risk of breast cancer from those at low risk, and can be implemented as an evidence-based recommendation to enhance appropriate referral from general practice to a symptomatic breast clinic. Ongoing validation in further populations is required.
PMCID: PMC3080225  PMID: 21619744
breast cancer; diagnosis; primary care
18.  A cluster randomised stepped wedge trial to evaluate the effectiveness of a multifaceted information technology-based intervention in reducing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets in primary medical care: The DQIP study protocol 
High-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents accounts for a significant proportion of hospital admissions due to preventable adverse drug events. The recently completed PINCER trial has demonstrated that a one-off pharmacist-led information technology (IT)-based intervention can significantly reduce high-risk prescribing in primary care, but there is evidence that effects decrease over time and employing additional pharmacists to facilitate change may not be sustainable.
We will conduct a cluster randomised controlled with a stepped wedge design in 40 volunteer general practices in two Scottish health boards. Eligible practices are those that are using the INPS Vision clinical IT system, and have agreed to have relevant medication-related data to be automatically extracted from their electronic medical records. All practices (clusters) that agree to take part will receive the data-driven quality improvement in primary care (DQIP) intervention, but will be randomised to one of 10 start dates. The DQIP intervention has three components: a web-based informatics tool that provides weekly updated feedback of targeted prescribing at practice level, prompts the review of individual patients affected, and summarises each patient's relevant risk factors and prescribing; an outreach visit providing education on targeted prescribing and training in the use of the informatics tool; and a fixed payment of 350 GBP (560 USD; 403 EUR) up front and a small payment of 15 GBP (24 USD; 17 EUR) for each patient reviewed in the 12 months of the intervention. We hypothesise that the DQIP intervention will reduce a composite of nine previously validated measures of high-risk prescribing. Due to the nature of the intervention, it is not possible to blind practices, the core research team, or the data analyst. However, outcome assessment is entirely objective and automated. There will additionally be a process and economic evaluation alongside the main trial.
The DQIP intervention is an example of a potentially sustainable safety improvement intervention that builds on the existing National Health Service IT-infrastructure to facilitate systematic management of high-risk prescribing by existing practice staff. Although the focus in this trial is on Non-steroidal anti-inflammatory drugs and antiplatelets, we anticipate that the tested intervention would be generalisable to other types of prescribing if shown to be effective.
Trial registration, dossier number: NCT01425502
PMCID: PMC3353207  PMID: 22444945
Adverse drug event; Non-steroidal anti-inflammatory drug; Antiplatelet; Medication error; Medication review; Decision support systems; Clinical; Stepped wedge; Randomised controlled trial; Primary healthcare
19.  Social, Environmental and Psychological Factors Associated with Objective Physical Activity Levels in the Over 65s 
PLoS ONE  2012;7(2):e31878.
To assess physical activity levels objectively using accelerometers in community dwelling over 65 s and to examine associations with health, social, environmental and psychological factors.
Cross sectional survey.
17 general practices in Scotland, United Kingdom.
Random sampling of over 65 s registered with the practices in four strata young-old (65–80 years), old-old (over 80 years), more affluent and less affluent groups.
Main Outcome Measures
Accelerometry counts of activity per day. Associations between activity and Theory of Planned Behaviour variables, the physical environment, health, wellbeing and demographic variables were examined with multiple regression analysis and multilevel modelling.
547 older people (mean (SD) age 79(8) years, 54% female) were analysed representing 94% of those surveyed. Accelerometry counts were highest in the affluent younger group, followed by the deprived younger group, with lowest levels in the deprived over 80 s group. Multiple regression analysis showed that lower age, higher perceived behavioural control, the physical function subscale of SF-36, and having someone nearby to turn to were all independently associated with higher physical activity levels (R2 = 0.32). In addition, hours of sunshine were independently significantly associated with greater physical activity in a multilevel model.
Other than age and hours of sunlight, the variables identified are modifiable, and provide a strong basis for the future development of novel multidimensional interventions aimed at increasing activity participation in later life.
PMCID: PMC3281090  PMID: 22359640
20.  Assessing Asthma control in UK primary care: Use of routinely collected prospective observational consultation data to determine appropriateness of a variety of control assessment models 
BMC Family Practice  2011;12:105.
Assessing asthma control using standardised questionnaires is recommended as good clinical practice but there is little evidence validating their use within primary care. There is however, strong empirical evidence to indicate that age, weight, gender, smoking, symptom pattern, medication use, health service resource use, geographical location, deprivation, and organisational issues, are factors strongly associated with asthma control. A good control measure is therefore one whose variation is most explained by these factors.
Eight binary (Yes = poor control, No = good control) models of asthma control were constructed from a large UK primary care dataset: the Royal College of Physicians 3-Questions (RCP-3Qs); the Jones Morbidity Index; three composite measures; three single component models. Accounting for practice clustering of patients, we investigated the effects of each model for assessing control. The binary models were assessed for goodness-of-fit statistics using Pseudo R-squared and Akaikes Information Criteria (AIC), and for performance using Area Under the Receiver Operator Characteristic (AUROC). In addition, an expanded RCP-3Q control scale (0-9) was derived and assessed with linear modelling. The analysis identified which model was best explained by the independent variables and thus could be considered a good model of control assessment.
1,205 practices provided information on 64,929 patients aged 13+ years. The RCP-3Q model provided the best fit statistically, with a Pseudo R-squared of 18%, and an AUROC of 0.79. By contrast, the composite model based on the GINA definition of controlled asthma had a higher AIC, an AUROC of 0.72, and only 10% variability explained. In addition, although the Peak Expiratory Flow Rate (PEFR) model had the lowest AIC, it had an AUROC of 71% and only 6% of variability explained. However, compared with the RCP-3Qs binary model, the linear RCP-3Q Total Score Model (Scale 0-9), was found to be a more robust 'tool' for assessing asthma control with a lower AIC (28,6163) and an R-squared of 33%.
In the absence of a gold standard for assessing asthma control in primary care, the results indicate that the RCP-3Qs is an effective control assessment tool but, for maximum effect, the expanded scoring model should be used.
PMCID: PMC3196897  PMID: 21958349
21.  New Users of Metformin Are at Low Risk of Incident Cancer 
Diabetes Care  2009;32(9):1620-1625.
The antidiabetic properties of metformin are mediated through its ability to activate the AMP-activated protein kinase (AMPK). Activation of AMPK can suppress tumor formation and inhibit cell growth in addition to lowering blood glucose levels. We tested the hypothesis that metformin reduces the risk of cancer in people with type 2 diabetes.
In an observational cohort study using record-linkage databases and based in Tayside, Scotland, U.K., we identified people with type 2 diabetes who were new users of metformin in 1994–2003. We also identified a set of diabetic comparators, individually matched to the metformin users by year of diabetes diagnosis, who had never used metformin. In a survival analysis we calculated hazard ratios for diagnosis of cancer, adjusted for baseline characteristics of the two groups using Cox regression.
Cancer was diagnosed among 7.3% of 4,085 metformin users compared with 11.6% of 4,085 comparators, with median times to cancer of 3.5 and 2.6 years, respectively (P < 0.001). The unadjusted hazard ratio (95% CI) for cancer was 0.46 (0.40–0.53). After adjusting for sex, age, BMI, A1C, deprivation, smoking, and other drug use, there was still a significantly reduced risk of cancer associated with metformin: 0.63 (0.53–0.75).
These results suggest that metformin use may be associated with a reduced risk of cancer. A randomized trial is needed to assess whether metformin is protective in a population at high risk for cancer.
PMCID: PMC2732153  PMID: 19564453
22.  Reduced-Function SLC22A1 Polymorphisms Encoding Organic Cation Transporter 1 and Glycemic Response to Metformin: A GoDARTS Study 
Diabetes  2009;58(6):1434-1439.
Metformin is actively transported into the liver by the organic cation transporter (OCT)1 (encoded by SLC22A1). In 12 normoglycemic individuals, reduced-function variants in SLC22A1 were shown to decrease the ability of metformin to reduce glucose excursion in response to oral glucose. We assessed the effect of two common loss-of-function polymorphisms in SLC22A1 on metformin response in a large cohort of patients with type 2 diabetes.
The Diabetes Audit and Research in Tayside Scotland (DARTS) database includes prescribing and biochemistry information and clinical phenotypes of all patients with diabetes within Tayside, Scotland, from 1992 onwards. R61C and 420del variants of SLC22A1 were genotyped in 3,450 patients with type 2 diabetes who were incident users of metformin. We assessed metformin response by modeling the maximum A1C reduction in 18 months after starting metformin and investigated whether a treatment target of A1C <7% was achieved. Sustained metformin effect on A1C between 6 and 42 months was also assessed, as was the time to metformin monotherapy failure. Covariates were SLC22A1 genotype, BMI, average drug dose, adherence, and creatinine clearance.
A total of 1,531 patients were identified with a definable metformin response. R61C and 420del variants did not affect the initial A1C reduction (P = 0.47 and P = 0.92, respectively), the chance of achieving a treatment target (P = 0.83 and P = 0.36), the average A1C on monotherapy up to 42 months (P = 0.44 and P = 0.75), or the hazard of monotherapy failure (P = 0.85 and P = 0.56).
The SLC22A1 loss-of-function variants, R61C and 420del, do not attenuate the A1C reduction achieved by metformin in patients with type 2 diabetes.
PMCID: PMC2682689  PMID: 19336679
23.  Outcomes for births booked under an independent midwife and births in NHS maternity units: matched comparison study 
Objective To compare clinical outcomes between women employing an independent midwife and comparable pregnant women using NHS services.
Design Anonymised matched cohort analysis. Cases from the database of the Independent Midwives’ Association (IMA) matched up to 1:5 with Scottish National Health Service (NHS) records for age, parity, year of birth, and socioeconomic status. Multivariable logistic regression models used to explore the relation between explanatory variables and outcomes; analyses controlled for potential confounding factors and adjusted for stratification.
Setting UK databases 2002-5.
Participants Anonymised records for 8676 women (7214 NHS; 1462 IMA).
Main outcome measures Unassisted vertex delivery, live birth, perinatal death, onset of labour, gestation, use of analgesia, duration of labour, perineal trauma, Apgar scores, admission to neonatal intensive care, infant feeding.
Results IMA cohort mothers were significantly more likely to achieve an unassisted vertex delivery than NHS cohort mothers (77.9% (1139) v 54.3% (3918); odds ratio 3.49, 95% confidence interval 2.99 to 4.07) but also significantly more likely to experience a stillbirth or a neonatal death (1.7% (25) v 0.6% (46); 5.91, 3.27 to 10.7). All odds ratios are adjusted for confounding factors. Exclusion of “high risk” cases from both cohorts showed a non-significant difference (0.5% (5) v 0.3% (18); 2.73, 0.87 to 8.55); the “low risk” IMA perinatal mortality rate is comparable with other studies of low risk births. Women in the IMA cohort had a higher incidence of pre-existing medical conditions (1.5% (22) v 1.0% (72) in the NHS cohort) and previous obstetric complications (21.0% (307) v 17.8% (1284)). The incidence of twin pregnancy was also higher (3.4% (50) v 3.1% (224)). In the IMA cohort, 66.0% of mothers (965/1462) had home births, compared with only 0.4% of NHS cohort mothers (27/7214). Spontaneous onset of labour was more common in the IMA group (96.6% (1405) v 74.5% (5365); 10.43, 7.74 to 14.0), and fewer mothers used pharmacological analgesia (40.2% (588) v 60.6% (4370); 0.42, 0.38 to 0.47). Mothers in the IMA cohort were much more likely to breast feed (88.0% (1286) v 64.0% (2759); 3.46, 2.84 to 4.20). Prematurity (4.3% (63) v 6.9% (498); 0.49, 0.35 to 0.69), low birth weight (4.0% (60) v 7.1%) (523); 0.93, 0.62 to 1.38), and rate of admission to neonatal intensive care (4.4% (65) v 9.3% (667); 0.43, 0.32 to 0.59) were all higher in the NHS dataset.
Conclusions Healthcare policy tries to direct patient choice towards clinically appropriate and practicable options; nevertheless, pregnant women are free to make decisions about birth preferences, including place of delivery and staff in attendance. While clinical outcomes across a range of variables were significantly better for women accessing an independent midwife, the significantly higher perinatal mortality rates for high risk cases in this group indicate an urgent need for a review of these cases. The significantly higher prematurity and admission rates to intensive care in the NHS cohort also indicate an urgent need for review.
PMCID: PMC2695511  PMID: 19520729
24.  The feasibility of using pedometers and brief advice to increase activity in sedentary older women – a pilot study 
People over the age of 70 carry the greatest burden of chronic disease, disability and health care use. Participation in physical activity is crucial for health, and walking accounts for much of the physical activity undertaken by sedentary individuals. Pedometers are a useful motivational tool to encourage increased walking and they are cheap and easy to use. The aim of this pilot study was to evaluate the feasibility of the use of pedometers plus a theory-based intervention to assist sedentary older women to accumulate increasing amounts of physical activity, mainly through walking.
Female participants over the age of 70 were recruited from primary care and randomised to receive either pedometer plus a theory-based intervention or a theory-based intervention alone. The theory-based intervention consisted of motivational techniques, goal-setting, barrier identification and self-monitoring with pedometers and daily diaries. The pedometer group were further randomised to one of three target groups: a 10%, 15% or 20% monthly increase in step count to assess the achievability and acceptability of a range of targets. The primary outcome was change in daily activity levels measured by accelerometry. Secondary outcome measures were lower limb function, health related quality of life, anxiety and depression.
54 participants were recruited into the study, with an average age of 76. There were 9 drop outs, 45 completing the study. All participants in the pedometer group found the pedometers easy to use and there was good compliance with diary keeping (96% in the pedometer group and 83% in the theory-based intervention alone group). There was a strong correlation (0.78) between accelerometry and pedometer step counts i.e. indicating that walking was the main physical activity amongst participants. There was a greater increase in activity (accelerometry) amongst those in the 20% target pedometer group compared to the other groups, although not reaching statistical significance (p = 0.192).
We have demonstrated that it is feasible to use pedometers and provide theory-based advice to community dwelling sedentary older women to increase physical activity levels and a larger study is planned to investigate this further.
PMCID: PMC2527003  PMID: 18691392
25.  Screening for left ventricular systolic dysfunction using GP-reported ECGs 
Diagnostic echocardiography has poor access for patients with suspected heart failure. Pre-echocardiography screening with electrocardiograms (ECGs) is recommended as a means of targeting this scarce resource. There are data to support this policy when ECGs are interpreted by cardiologists but not by GPs.
To assess the value of GP-reported ECGs as a pre-echocardiography screening test for left ventricular systolic dysfunction (LVSD).
Design of study
Cross-sectional study of GPs' ECG reporting skills.
General practice, NHS in Scotland.
A randomly selected, stratified sample of 123 Scottish GPs reviewed 180 ECGs (100 abnormal, 50 normal and 30 duplicate) from 150 patients with suspected heart failure. Forty-one patients had LVSD on echocardiography. GPs were required to categorise ECGs as normal or abnormal.
Mean sensitivity was 0.94 (95% CI = 0.92 to 0.95). Mean specificity 0.58 (95% CI = 0.56 to 0.60). Mean positive predictive value (PPV) was 0.47 (95% CI = 0.46 to 0.48). Mean negative predictive value (NPV) was 0.96 (95% CI = 0.95 to 0.97). Mean likelihood ratio was 2.39 (95% CI = 2.28 to 2.50). Seventy of 123 (57%) GPs achieved sensitivity of 0.9 and specificity of 0.5 for the detection of LVSD.
Most Scottish GPs have the skills to perform pre-echocardiography screening ECGs in patients with suspected LVSD. However, differences in ECG reporting performance between individual GPs will result in widely varying referral rates for echocardiography and differences in the detection rate of LVSD. The implications of these findings need to be considered when heart failure diagnostic services are being developed.
PMCID: PMC2042566  PMID: 17359605
ECG; echocardiography; left ventricular systolic dysfunction; screening

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