Search tips
Search criteria

Results 1-15 (15)

Clipboard (0)

Select a Filter Below

more »
Year of Publication
author:("mccown, Colin")
1.  A hard pill to swallow: a qualitative study of women's experiences of adjuvant endocrine therapy for breast cancer 
BMJ Open  2014;4(6):e005285.
To explore women's experiences of taking adjuvant endocrine therapy as a treatment for breast cancer and how their beliefs about the purpose of the medication, side effects experienced and interactions with health professionals might influence adherence.
Qualitative study using semistructured, one-to-one interviews.
2 hospitals from a single health board in Scotland.
30 women who had been prescribed tamoxifen or aromatase inhibitors (anastrozole or letrozole) and had been taking this medication for 1–5 years.
Women clearly wished to take their adjuvant endocrine therapy medication as prescribed, believing that it offered them protection against breast cancer recurrence. However, some women missed tablets and did not recognise that this could reduce the efficacy of the treatment. Women did not perceive that healthcare professionals were routinely or systematically monitoring their adherence. Side effects were common and impacted greatly on the women’s quality of life but did not always cause women to stop taking their medication, or to seek advice about reducing the side effects they experienced. Few were offered the opportunity to discuss the impact of side effects or the potential options available.
Although most women in this study took adjuvant endocrine therapy as prescribed, many endured a range of side effects, often without seeking help. Advice, support and monitoring for adherence are not routinely offered in conventional follow-up settings. Women deserve more opportunity to discuss the pros, cons and impact of long-term adjuvant endocrine therapy. New service models are needed to support adherence, enhance quality of life and ultimately improve survival. These should ideally be community based, in order to promote self-management in the longer term.
PMCID: PMC4067895  PMID: 24928595
2.  Neurobehavioral consequences of chronic intrauterine opioid exposure in infants and preschool children: a systematic review and meta-analysis 
BMC Psychiatry  2014;14:104.
It is assumed within the accumulated literature that children born of pregnant opioid dependent mothers have impaired neurobehavioral function as a consequence of chronic intrauterine opioid use.
Quantitative and systematic review of the literature on the consequences of chronic maternal opioid use during pregnancy on neurobehavioral function of children was conducted using the Meta-analysis of Observational Studies in Epidemiology (MOOSE) and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. We searched Cinahl, EMBASE, PsychINFO and MEDLINE between the periods of January 1995 to January 2012.
There were only 5 studies out of the 200 identified that quantitatively reported on neurobehavioral function of children after maternal opioid use during pregnancy. All 5 were case control studies with the number of exposed subjects within the studies ranging from 33–143 and 45–85 for the controls. This meta-analysis showed no significant impairments, at a non-conservative significance level of p < 0.05, for cognitive, psychomotor or observed behavioural outcomes for chronic intra-uterine exposed infants and pre-school children compared to non-exposed infants and children. However, all domains suggested a trend to poor outcomes in infants/children of opioid using mothers. The magnitude of all possible effects was small according to Cohen’s benchmark criteria.
Chronic intra-uterine opioid exposed infants and pre-school children experienced no significant impairment in neurobehavioral outcomes when compared to non-exposed peers, although in all domains there was a trend to poorer outcomes. The findings of this review are limited by the small number of studies analysed, the heterogenous populations and small numbers within the individual studies. Longitudinal studies are needed to determine if any neuropsychological impairments appear after the age of 5 years and to help investigate further the role of environmental risk factors on the effect of ‘core’ phenotypes.
PMCID: PMC4021271  PMID: 24708875
Neuropsychology; Psychomotor; Cognition; Methadone; Opioids; Meta-analysis
4.  Differential Impact of Two Risk Communications on Antipsychotic Prescribing to People with Dementia in Scotland: Segmented Regression Time Series Analysis 2001–2011 
PLoS ONE  2013;8(7):e68976.
Regulatory risk communications are an important method for disseminating drug safety information, but their impact varies. Two significant UK risk communications about antipsychotic use in older people with dementia were issued in 2004 and 2009. These varied considerably in their content and dissemination, allowing examination of their differential impact.
Segmented regression time-series analysis 2001–2011 for people aged ≥65 years with dementia in 87 Scottish general practices, examining the impact of two pre-specified risk communications in 2004 and 2009 on antipsychotic and other psychotropic prescribing.
The percentage of people with dementia prescribed an antipsychotic was 15.9% in quarter 1 2001 and was rising by an estimated 0.6%/quarter before the 2004 risk communication. The 2004 risk communication was sent directly to all prescribers, and specifically recommended review of all patients prescribed relevant drugs. It was associated with an immediate absolute reduction in antipsychotic prescribing of 5.9% (95% CI −6.6 to −5.2) and a change to a stable level of prescribing subsequently. The 2009 risk communication was disseminated in a limited circulation bulletin, and only specifically recommended avoiding initiation if possible. There was no immediate associated impact, but it was associated with a significant decline in prescribing subsequently which appeared driven by a decline in initiation, with the percentage prescribed an antipsychotic falling from 18.4% in Q1 2009 to 13.5% in Q1 2011. There was no widespread substitution of antipsychotics with other psychotropic drugs.
The two risk communications were associated with reductions in antipsychotic use, in ways which were compatible with marked differences in their content and dissemination. Further research is needed to ensure that the content and dissemination of regulatory risk communications is optimal, and to track their impact on intended and unintended outcomes. Although rates are falling, antipsychotic prescribing in dementia in Scotland remains unacceptably high.
PMCID: PMC3714253  PMID: 23874832
5.  Community acquired infections in older patients admitted to hospital from care homes versus the community: cohort study of microbiology and outcomes 
BMC Geriatrics  2013;13:12.
Residents of care homes are at risk of colonisation and infection with antibiotic resistant bacteria, but there is little evidence that antibiotic resistance among such patients is associated with worse outcomes than among older people living in their own homes. Our aim was to compare the prevalence of antibiotic resistant bacteria and clinical outcomes in older patients admitted to hospital with acute infections from care homes versus their own homes.
We enrolled patients admitted to Ninewells Hospital in 2005 who were older than 64 years with onset of acute community acquired respiratory tract, urinary tract or skin and soft tissue infections, and with at least one sample sent for culture. The primary outcome was 30 day mortality, adjusted for age, sex, Charlson Index of co-morbidity, sepsis severity, presence of resistant isolates and resistance to initial therapy.
161 patients were identified, 60 from care homes and 101 from the community. Care home patients were older, had more co-morbidities, and higher rates of resistant bacteria, including MRSA and Gram negative organisms resistant to co-amoxiclav, cefuroxime and/or ciprofloxacin, overall (70% versus 36%, p = 0.026). 30 day mortality was high in both groups (30% in care home patients and 24% in comparators). In multivariate logistic regression we found that place of residence did not predict 30 day mortality (adjusted odds ratio (OR) for own home versus care home 1.01, 95% CI 0.40-2.52, p = 0.984). Only having severe sepsis predicted 30 day mortality (OR 10.09, 95% CI 3.37-30.19, p < 0.001), after adjustment for age, sex, co-morbidity, presence of resistant bacteria, resistance to initial therapy, and place of residence.
Older patients admitted with acute infection had high 30 day mortality. Patients from care homes were more likely to have resistant organisms but high levels of antimicrobial resistance were found in both groups. Thus, we recommend that antibiotic therapies active against resistant organisms, guided by local resistance patterns, should be considered for all older patients admitted with severe sepsis regardless of their place of residence.
PMCID: PMC3574846  PMID: 23388032
Long-term care facilities; Nursing home; Care home; Sepsis; Severity of infection; Antibiotic policy
6.  What do we know about who does and does not attend general health checks? Findings from a narrative scoping review 
BMC Public Health  2012;12:723.
General and preventive health checks are a key feature of contemporary policies of anticipatory care. Ensuring high and equitable uptake of such general health checks is essential to ensuring health gain and preventing health inequalities. This literature review explores the socio-demographic, clinical and social cognitive characteristics of those who do and do not engage with general health checks or preventive health checks for cardiovascular disease.
An exploratory scoping study approach was employed. Databases searched included the British Nursing Index and Archive, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Database of Systematic Reviews (CDSR) and Database of Abstracts of Reviews of Effects (DARE), EMBASE, MEDLINE, PsycINFO and the Social Sciences Citation Index (SSCI). Titles and abstracts of 17463 papers were screened; 1171 papers were then independently assessed by two researchers. A review of full text was carried out by two of the authors resulting in 39 being included in the final review.
Those least likely to attend health checks were men on low incomes, low socio-economic status, unemployed or less well educated. In general, attenders were older than non-attenders. An individual’s marital status was found to affect attendance rates with non-attenders more likely to be single. In general, white individuals were more likely to engage with services than individuals from other ethnic backgrounds. Non-attenders had a greater proportion of cardiovascular risk factors than attenders, and smokers were less likely to attend than non-smokers. The relationship between health beliefs and health behaviours appeared complex. Non-attenders were shown to value health less strongly, have low self-efficacy, feel less in control of their health and be less likely to believe in the efficacy of health checks.
Routine health check-ups appear to be taken up inequitably, with gender, age, socio-demographic status and ethnicity all associated with differential service use. Furthermore, non-attenders appeared to have greater clinical need or risk factors suggesting that differential uptake may lead to sub-optimal health gain and contribute to inequalities via the inverse care law. Appropriate service redesign and interventions to encourage increased uptake among these groups is required.
PMCID: PMC3491052  PMID: 22938046
Health checks; Screening; Public health; Inequalities; Primary care
7.  Authors' response 
PMCID: PMC3103680
8.  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
9.  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
10.  Quality and safety of medication use in primary care: consensus validation of a new set of explicit medication assessment criteria and prioritisation of topics for improvement 
Addressing the problem of preventable drug related morbidity (PDRM) in primary care is a challenge for health care systems internationally. The increasing implementation of clinical information systems in the UK and internationally provide new opportunities to systematically identify patients at risk of PDRM for targeted medication review. The objectives of this study were (1) to develop a set of explicit medication assessment criteria to identify patients with sub-optimally effective or high-risk medication use from electronic medical records and (2) to identify medication use topics that are perceived by UK primary care clinicians to be priorities for quality and safety improvement initiatives.
For objective (1), a 2-round consensus process based on the RAND/UCLA Appropriateness Method (RAM) was conducted, in which candidate criteria were identified from the literature and scored by a panel of 10 experts for 'appropriateness' and 'necessity'. A set of final criteria was generated from candidates accepted at each level. For objective (2), thematically related final criteria were clustered into 'topics', from which a panel of 26 UK primary care clinicians identified priorities for quality improvement in a 2-round Delphi exercise.
(1) The RAM process yielded a final set of 176 medication assessment criteria organised under the domains 'quality' and 'safety', each classified as targeting 'appropriate/necessary to do' (quality) or 'inappropriate/necessary to avoid' (safety) medication use. Fifty-two final 'quality' assessment criteria target patients with unmet indications, sub-optimal selection or intensity of beneficial drug treatments. A total of 124 'safety' assessment criteria target patients with unmet needs for risk-mitigating agents, high-risk drug selection, excessive dose or duration, inconsistent monitoring or dosing instructions. (2) The UK Delphi panel identified 11 (23%) of 47 scored topics as 'high priority' for quality improvement initiatives in primary care.
The developed criteria set complements existing medication assessment instruments in that it is not limited to the elderly, can be implemented in electronic data sets and focuses on drug groups and conditions implicated in common and/or severe PDRM in primary care. Identified priorities for quality and safety improvement can guide the selection of targets for initiatives to address the PDRM problem in primary care.
PMCID: PMC3296596  PMID: 22316181
Medication error; quality indicator; primary health care; adverse drug events; preventable drug related morbidity
11.  Framework for the impact analysis and implementation of Clinical Prediction Rules (CPRs) 
Clinical Prediction Rules (CPRs) are tools that quantify the contribution of symptoms, clinical signs and available diagnostic tests, and in doing so stratify patients according to the probability of having a target outcome or need for a specified treatment. Most focus on the derivation stage with only a minority progressing to validation and very few undergoing impact analysis. Impact analysis studies remain the most efficient way of assessing whether incorporating CPRs into a decision making process improves patient care. However there is a lack of clear methodology for the design of high quality impact analysis studies.
We have developed a sequential four-phased framework based on the literature and the collective experience of our international working group to help researchers identify and overcome the specific challenges in designing and conducting an impact analysis of a CPR.
There is a need to shift emphasis from deriving new CPRs to validating and implementing existing CPRs. The proposed framework provides a structured approach to this topical and complex area of research.
PMCID: PMC3216240  PMID: 21999201
12.  The external validity of published randomized controlled trials in primary care 
BMC Family Practice  2009;10:5.
A criticism of Randomized Controlled Trials (RCTs) in primary care is that they lack external validity, participants being unrepresentative of the wider population. Our aim was to determine whether published primary care-based RCTs report information about how the study sample is assembled, and whether this is associated with RCT characteristics.
We reviewed RCTs published in four primary care journals in the years 2001–2004. Main outcomes were: (1) eligibility fraction (proportion eligible of those screened), (2) enrolment fraction (proportion randomised of those eligible), (3) recruitment fraction (proportion of potential participants actually randomised), and (4) number of patients needed to be screened (NNS) in order to randomize one participant.
A total of 148 RCTs were reviewed. One hundred and three trials (70%) reported the number of individuals assessed by investigators for eligibility, 119 (80%) reported the number eligible for participation, and all reported the actual number recruited. The median eligibility fraction was 83% (IQR 40% to 100%), and the median enrolment fraction was 74% (IQR 49% to 92%). The median NNS was 2.43, with some trials reportedly recruiting every patient or practice screened for eligibility, and one trial screening 484 for each patient recruited. We found no association between NNS and journal, trial size, multi- or single-centre, funding source or type of intervention. There may be associations between provision of sufficient recruitment data for the calculation of NNS and funding source and type of intervention.
RCTs reporting recruitment data in primary care suggest that once screened for eligibility and found to match inclusion criteria patients are likely to be randomized. This finding needs to be treated with caution as it may represent inadequate identification or reporting of the eligible population. A substantial minority of RCTs did not provide sufficient information about the patient recruitment process.
PMCID: PMC2632986  PMID: 19152681
13.  Leaders, leadership and future primary care clinical research 
BMC Family Practice  2008;9:52.
A strong and self confident primary care workforce can deliver the highest quality care and outcomes equitably and cost effectively. To meet the increasing demands being made of it, primary care needs its own thriving research culture and knowledge base.
Review of recent developments supporting primary care clinical research.
Primary care research has benefited from a small group of passionate leaders and significant investment in recent decades in some countries. Emerging from this has been innovation in research design and focus, although less is known of the effect on research output.
Primary care research is now well placed to lead a broad re-vitalisation of academic medicine, answering questions of relevance to practitioners, patients, communities and Government. Key areas for future primary care research leaders to focus on include exposing undergraduates early to primary care research, integrating this early exposure with doctoral and postdoctoral research career support, further expanding cross disciplinary approaches, and developing useful measures of output for future primary care research investment.
PMCID: PMC2565662  PMID: 18822178
14.  Clinical symptoms and ‘off-label’ prescribing in children with asthma 
A UK-wide database of structured asthma review consultations was used to investigate the prevalence of ‘off-label’ anti-asthma prescriptions in relationship to clinical symptoms of asthma control. The 1050 children (6.1%) aged 16 years or under issued with an off-label prescription reported more nighttime, daytime and activity asthma symptoms, and used more short-acting β2-agonist medication than their peers. Off-label prescribing for children with asthma in UK primary care is associated with worse levels of self-reported asthma control.
PMCID: PMC2042555  PMID: 17359609
asthma; child health; drug labeling; family practice; prescriptions

Results 1-15 (15)