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1.  TElehealth in CHronic disease: mixed-methods study to develop the TECH conceptual model for intervention design and evaluation 
BMJ Open  2015;5(2):e006448.
To develop a conceptual model for effective use of telehealth in the management of chronic health conditions, and to use this to develop and evaluate an intervention for people with two exemplar conditions: raised cardiovascular disease risk and depression.
The model was based on several strands of evidence: a metareview and realist synthesis of quantitative and qualitative evidence on telehealth for chronic conditions; a qualitative study of patients’ and health professionals’ experience of telehealth; a quantitative survey of patients’ interest in using telehealth; and review of existing models of chronic condition management and evidence-based treatment guidelines. Based on these evidence strands, a model was developed and then refined at a stakeholder workshop. Then a telehealth intervention (‘Healthlines’) was designed by incorporating strategies to address each of the model components. The model also provided a framework for evaluation of this intervention within parallel randomised controlled trials in the two exemplar conditions, and the accompanying process evaluations and economic evaluations.
Primary care.
The TElehealth in CHronic Disease (TECH) model proposes that attention to four components will offer interventions the best chance of success: (1) engagement of patients and health professionals, (2) effective chronic disease management (including subcomponents of self-management, optimisation of treatment, care coordination), (3) partnership between providers and (4) patient, social and health system context. Key intended outcomes are improved health, access to care, patient experience and cost-effective care.
A conceptual model has been developed based on multiple sources of evidence which articulates how telehealth may best provide benefits for patients with chronic health conditions. It can be used to structure the design and evaluation of telehealth programmes which aim to be acceptable to patients and providers, and cost-effective.
PMCID: PMC4322202  PMID: 25659890
2.  Risk Prediction Models to Predict Emergency Hospital Admission in Community-dwelling Adults 
Medical Care  2014;52(8):751-765.
Supplemental Digital Content is available in the text.
Risk prediction models have been developed to identify those at increased risk for emergency admissions, which could facilitate targeted interventions in primary care to prevent these events.
Systematic review of validated risk prediction models for predicting emergency hospital admissions in community-dwelling adults.
A systematic literature review and narrative analysis was conducted. Inclusion criteria were as follows; Population: community-dwelling adults (aged 18 years and above); Risk: risk prediction models, not contingent on an index hospital admission, with a derivation and ≥1 validation cohort; Primary outcome: emergency hospital admission (defined as unplanned overnight stay in hospital); Study design: retrospective or prospective cohort studies.
Of 18,983 records reviewed, 27 unique risk prediction models met the inclusion criteria. Eleven were developed in the United States, 11 in the United Kingdom, 3 in Italy, 1 in Spain, and 1 in Canada. Nine models were derived using self-report data, and the remainder (n=18) used routine administrative or clinical record data. Total study sample sizes ranged from 96 to 4.7 million participants. Predictor variables most frequently included in models were: (1) named medical diagnoses (n=23); (2) age (n=23); (3) prior emergency admission (n=22); and (4) sex (n=18). Eleven models included nonmedical factors, such as functional status and social supports. Regarding predictive accuracy, models developed using administrative or clinical record data tended to perform better than those developed using self-report data (c statistics 0.63–0.83 vs. 0.61–0.74, respectively). Six models reported c statistics of >0.8, indicating good performance. All 6 included variables for prior health care utilization, multimorbidity or polypharmacy, and named medical diagnoses or prescribed medications. Three predicted admissions regarded as being ambulatory care sensitive.
This study suggests that risk models developed using administrative or clinical record data tend to perform better. In applying a risk prediction model to a new population, careful consideration needs to be given to the purpose of its use and local factors.
PMCID: PMC4219489  PMID: 25023919
risk prediction model; emergency hospital admission; community-dwelling adults
3.  The development of the PROMPT (PRescribing Optimally in Middle-aged People’s Treatments) criteria 
Whilst multimorbidity is more prevalent with increasing age, approximately 30% of middle-aged adults (45–64 years) are also affected. Several prescribing criteria have been developed to optimise medication use in older people (≥65 years) with little focus on potentially inappropriate prescribing (PIP) in middle-aged adults. We have developed a set of explicit prescribing criteria called PROMPT (PRescribing Optimally in Middle-aged People’s Treatments) which may be applied to prescribing datasets to determine the prevalence of PIP in this age-group.
A literature search was conducted to identify published prescribing criteria for all age groups, with the Project Steering Group (convened for this study) adding further criteria for consideration, all of which were reviewed for relevance to middle-aged adults. These criteria underwent a two-round Delphi process, using an expert panel consisting of general practitioners, pharmacists and clinical pharmacologists from the United Kingdom and Republic of Ireland. Using web-based questionnaires, 17 panellists were asked to indicate their level of agreement with each criterion via a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree) to assess the applicability to middle-aged adults in the absence of clinical information. Criteria were accepted/rejected/revised dependent on the panel’s level of agreement using the median response/interquartile range and additional comments.
Thirty-four criteria were rated in the first round of this exercise and consensus was achieved on 17 criteria which were accepted into the PROMPT criteria. Consensus was not reached on the remaining 17, and six criteria were removed following a review of the additional comments. The second round of this exercise focused on the remaining 11 criteria, some of which were revised following the first exercise. Five criteria were accepted from the second round, providing a final list of 22 criteria [gastro-intestinal system (n = 3), cardiovascular system (n = 4), respiratory system (n = 4), central nervous system (n = 6), infections (n = 1), endocrine system (n = 1), musculoskeletal system (n = 2), duplicates (n = 1)].
PROMPT is the first set of prescribing criteria developed for use in middle-aged adults. The utility of these criteria will be tested in future studies using prescribing datasets.
PMCID: PMC4229620  PMID: 25410615
Potentially inappropriate prescribing; Explicit criteria; Delphi technique; Middle-age; Polypharmacy; Multimorbidity
4.  Development and validation of a clinical prediction rule to identify suspected breast cancer: a prospective cohort study 
BMC Cancer  2014;14(1):743.
The number of primary care referrals of women with breast symptoms to symptomatic breast units (SBUs) has increased exponentially in the past decade in Ireland. The aim of this study is to develop and validate a clinical prediction rule (CPR) to identify women with breast cancer so that a more evidence based approach to referral from primary care to these SBUs can be developed.
We analysed routine data from a prospective cohort of consecutive women reviewed at a SBU with breast symptoms. The dataset was split into a derivation and validation cohort. Regression analysis was used to derive a CPR from the patient’s history and clinical findings. Validation of the CPR consisted of estimating the number of breast cancers predicted to occur compared with the actual number of observed breast cancers across deciles of risk.
A total of 6,590 patients were included in the derivation study and 4.9% were diagnosed with breast cancer. Independent clinical predictors for breast cancer were: increasing age by year (adjusted odds ratio 1.08, 95% CI 1.07-1.09); presence of a lump (5.63, 95% CI 4.2-7.56); nipple change (2.77, 95% CI 1.68-4.58) and nipple discharge (2.09, 95% CI 1.1-3.97). Validation of the rule (n = 911) demonstrated that the probability of breast cancer was higher with an increasing number of these independent variables. The Hosmer-Lemeshow goodness of fit showed no overall significant difference between the expected and the observed numbers of breast cancer (χ2HL: 6.74, p-value: 0.56).
This study derived and validated a CPR for breast cancer in women attending an Irish national SBU. We found that increasing age, presence of a lump, nipple discharge and nipple change are all associated with increased risk of breast cancer. Further validation of the rule is necessary as well as an assessment of its impact on referral practice.
PMCID: PMC4197234  PMID: 25277332
Breast cancer; Diagnosis; Primary care
5.  Interventions to improve adherence to lipid lowering medication 
Lipid lowering drugs are still widely underused, despite compelling evidence about their effectiveness in the treatment and prevention of cardiovascular disease. Poor patient adherence to medication regimen is a major factor in the lack of success in treating hyperlipidaemia. In this review we focus on interventions, which encourage patients at risk of heart disease or stroke to take lipid lowering medication regularly.
To assess the effect of interventions aiming at improved adherence to lipid lowering drugs, focusing on measures of adherence and clinical outcomes.
Search strategy
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycInfo and CINAHL. Date of most recent search was in February 2003. No language restrictions were applied.
Selection criteria
Randomised controlled trials of adherence-enhancing interventions to lipid lowering medication in adults for both primary and secondary prevention of cardiovascular disease in an ambulatory setting.
Data collection and analysis
Two reviewers extracted data independently and assessed studies according to criteria outlined by the Cochrane Reviewers’ Handbook.
Main results
The eight studies found contained data on 5943 patients. Interventions could be stratified into four categories: 1. simplification of drug regimen, 2. patient information/education, 3. intensified patient care such as reminding and 4. complex behavioural interventions such as group sessions. Change in adherence ranged from −3% to 25% (decrease in adherence by 3% to increase in adherence by 25%). Three studies reported significantly improved adherence through simplification of drug regimen (category 1), improved patient information/education (category 2) and reminding (category 3). The fact that the successful interventions were evenly spread across the categories, does not suggest any advantage of one particular type of intervention. The methodological and analytical quality was generally low and results have to be considered with caution. Combining data was not appropriate due to the substantial heterogeneity between included randomised controlled trials (RCTs).
Authors’ conclusions
At this stage, no specific intervention aimed at improving adherence to lipid lowering drugs can be recommended. The lack of a gold standard method of measuring adherence is one major barrier in adherence research. More reliable data might be achieved by newer methods of measurement, more consistency in adherence assessment and longer duration of follow-up. Increased patient-centredness with emphasis on the patient’s perspective and shared-decision-making might lead to more conclusive answers when searching for tools to encourage patients to take lipid lowering medication.
PMCID: PMC4163627  PMID: 15495105
*Patient Compliance; Antilipemic Agents [*therapeutic use]; Cardiovascular Diseases [prevention & control]; Randomized Controlled Trials as Topic; Humans
6.  Potentially inappropriate prescribing among older people in the United Kingdom 
BMC Geriatrics  2014;14:72.
Potentially inappropriate prescribing (PIP) in older people is associated with increases in morbidity, hospitalisation and mortality. The objective of this study was to estimate the prevalence of and factors associated with PIP, among those aged ≥70 years, in the United Kingdom, using a comprehensive set of prescribing indicators and comparing these to estimates obtained from a truncated set of the same indicators.
A retrospective cross-sectional study was carried out in the UK Clinical Practice Research Datalink (CPRD), in 2007. Participants included those aged ≥ 70 years, in CPRD. Fifty-two PIP indicators from the Screening Tool of Older Persons Potentially Inappropriate Prescriptions (STOPP) criteria were applied to data on prescribed drugs and clinical diagnoses. Overall prevalence of PIP and prevalence according to individual STOPP criteria were estimated. The relationship between PIP and polypharmacy (≥4 medications), comorbidity, age, and gender was examined. A truncated, subset of 28 STOPP criteria that were used in two previous studies, were further applied to the data to facilitate comparison.
Using 52 indicators, the overall prevalence of PIP in the study population (n = 1,019,491) was 29%. The most common examples of PIP were therapeutic duplication (11.9%), followed by use of aspirin with no indication (11.3%) and inappropriate use of proton pump inhibitors (PPIs) (3.7%). PIP was strongly associated with polypharmacy (Odds Ratio 18.2, 95% Confidence Intervals, 18.0-18.4, P < 0.05). PIP was more common in those aged 70–74 years vs. 85 years or more and in males. Application of the smaller subset of the STOPP criteria resulted in a lower PIP prevalence at 14.9% (95% CIs 14.8-14.9%) (n = 151,598). The most common PIP issues identified with this subset were use of PPIs at maximum dose for > 8 weeks, NSAIDs for > 3 months, and use of long-term neuroleptics.
PIP was prevalent in the UK and increased with polypharmacy. Application of the comprehensive set of STOPP criteria allowed more accurate estimation of PIP compared to the subset of criteria used in previous studies. These findings may provide a focus for targeted interventions to reduce PIP.
PMCID: PMC4091750  PMID: 24919523
Potentially inappropriate prescribing; Older people; Screening tool of older persons potentially inappropriate Prescriptions (STOPP); CPRD
7.  Long-term risk of stroke after transient ischaemic attack: a hospital-based validation of the ABCD2 rule 
BMC Research Notes  2014;7:281.
The ABCD2 clinical prediction rule is a seven point summation of clinical factors independently predictive of stroke risk. The purpose of this cohort study is to validate the ABCD2 rule in a Bulgarian hospital up to three years after TIA.
All consecutive admissions to an emergency department with symptoms of a first TIA were included. Baseline data and clinical examinations including the ABCD2 scores were documented by neurologists. Discrimination and calibration performance was examined using ABCD2 cut-off scores of ≥3, ≥4 and ≥5 points, consistent with the international guidelines. The Hosmer-Lemeshow test was used to examine calibration between the observed and expected outcomes as predicted by ABCD2 score within the logistic regression analysis.
Eighty-nine patients were enrolled to the study with a mean age of 63 years (+/- 12 years). Fifty-nine percent (n = 53) of the study population was male. Seven strokes (7 · 8%) occurred within the first year and six further strokes within the three-year follow-up period. There was no incident of stroke within the first 90 days after TIA. The rule demonstrated good predictive (OR = 1 · 58, 95% CI 1 · 09-2 · 29) and discriminative performance (AUCROC = 0 · 72, 95% CI 0 · 58-0 · 86), as well as a moderate calibration performance at three years.
This validation of the ABCD2 rule in a Bulgarian hospital demonstrates that the rule has good predictive and discriminative performance at three years. The ABCD2 is quick to administer and may serve as a useful tool to assist clinicians in the long-term management of individuals with TIA.
PMCID: PMC4013429  PMID: 24886654
Stroke; Transient ischaemic attack; Risk prediction; ABCD2 rule; Bulgaria
8.  Potential for alcohol and drug interactions in older adults: evidence from the Irish longitudinal study on ageing 
BMC Geriatrics  2014;14:57.
Older adults are susceptible to adverse effects from the concomitant use of prescription medications and alcohol. This study estimates the prevalence of exposure to alcohol interactive (AI) medications and concomitant alcohol use by therapeutic class in a large, nationally representative sample of older adults.
Cross-sectional analysis of a population based sample of older Irish adults aged ≥60 years using data from The Irish Longitudinal Study on Ageing (TILDA) (N = 3,815). AI medications were identified using Stockley’s Drug Interactions, the British National Formulary and the Irish Medicines Formulary. An in-home inventory of medications was used to characterise AI drug exposure by therapeutic class. Self-reported alcohol use was classified as non-drinker, light/moderate and heavy drinking. Comorbidities known to be exacerbated by alcohol were also recorded (diabetes mellitus, hypertension, peptic ulcer disease, liver disease, depression, gout or breast cancer), as well as sociodemographic and health factors.
Seventy-two per cent of participants were exposed to AI medications, with greatest exposure to cardiovascular and CNS agents. Overall, 60% of participants exposed to AI medications reported concomitant alcohol use, compared with 69.5% of non-AI exposed people (p < 0.001). Almost 28% of those reporting anti-histamine use were identified as heavy drinkers. Similarly almost one in five, combined heavy drinking with anti-coagulants/anti-platelets and cardiovascular agents, with 16% combining heavy drinking with CNS agents. Multinomial logistic regression showed that being male, younger, urban dwelling, with higher levels of education and a history of smoking, were associated with an increased risk for concomitant exposure to alcohol consumption (both light/moderate and heavier) and AI medications. Current smokers and people with increasing co-morbidities were also at greatest risk for heavy drinking in combination with AI medications.
The concurrent use of alcohol with AI medications, or with conditions known to be exacerbated by alcohol, is common among older Irish adults. Prescribers should be aware of potential interactions, and screen patients for alcohol use and provide warnings to minimize patient risk.
PMCID: PMC4008399  PMID: 24766969
Drug interactions; Alcohol interactive medications; Alcohol drinking/epidemiology; Aged
9.  Prescriber variation in potentially inappropriate prescribing in older populations in Ireland 
BMC Family Practice  2014;15:59.
Health care policy-makers look for prescribing indicators at the population level to evaluate the performance of prescribers, improve quality and control drug costs. The aim of this research was to; (i) estimate the level of variation in potentially inappropriate prescribing (PIP) across prescribers in the national Irish older population using the STOPP criteria; (ii) estimate how reliably the criteria could distinguish between prescribers in terms of their proportion of PIP and; (iii) examine how PIP varies between prescribers and by patient and prescriber characteristics in a multilevel regression model.
1,938 general practitioners (GPs) with 338,375 registered patients’ ≥70 years were extracted from the Health Service Executive Primary Care Reimbursement Service (HSE-PCRS) pharmacy claims database. HSE-PCRS prescriptions are WHO ATC coded. Demographic data for claimants’ and prescribers’ are available. Thirty STOPP indicators were applied to prescription claims in 2007. Multilevel logistic regression examined how PIP varied between prescribers and by individual patient and prescriber level variables.
The unadjusted variation in PIP between prescribers was considerable (median 35%, IQR 30-40%). The STOPP criteria were reliable measures of PIP (average >0.8 reliability). The multilevel regression models found that only the patient level variable, number of different repeat drug classes was strongly associated with PIP (>2 drugs v none; adjusted OR, 4.0; 95% CI 3.7, 4.3). After adjustment for patient level variables the proportion of PIP varied fourfold (0.5 to 2 times the expected proportion) between prescribers but the majority of this variation was not significant.
PIP is of concern for all prescribers. Interventions aimed at enhancing appropriateness of prescribing should target patients taking multiple medications.
PMCID: PMC4021047  PMID: 24690127
Potentially inappropriate prescribing; General practice; Prescriber variation; STOPP; Older populations
10.  Prevalence of potentially inappropriate prescribing and prescribing omissions in older Irish adults: findings from The Irish LongituDinal Study on Ageing study (TILDA) 
We sought to estimate the prevalence of potentially inappropriate prescriptions (PIP) and potential prescribing omissions (PPOs) using a subset of the STOPP/START criteria in a population based sample of Irish adults aged ≥65 years using data from The Irish LongituDinal Study on Ageing (TILDA).
A subset of 26 PIP indicators and 10 PPO indicators from the STOPP/START criteria were applied to the TILDA dataset. PIP/PPO prevalence according to individual STOPP/START criteria and the overall prevalence of PIP/PPO were estimated. The relationship between PIP and PPOs and polypharmacy, age, gender and multimorbidity was examined using logistic regression.
The overall prevalence of PIP in the study population (n = 3,454) was 14.6 %. The most common examples of PIP identified were NSAID with moderate-severe hypertension (200 participants; 5.8 %) and aspirin with no history of coronary, cerebral, or peripheral vascular symptoms or occlusive event (112 participants; 3.2 %). The overall prevalence of PPOs was 30 % (n = 1,035). The most frequent PPO was antihypertensive therapy where systolic blood pressure consistently >160 mmHg (n = 341, 9.9 %), There was a significant association between PIP and PPO and polypharmacy when adjusting for age, sex and multimorbidity (adjusted OR 2.62, 95 % CI 2.05–3.33 for PIP and adjusted OR 1.46, 95 % CI 1.23–1.75 for prescribing omissions).
Our findings indicate prescribing omissions are twice as prevalent as PIP in the elderly using a subset of the STOPP/START criteria as an explicit process measure of potentially inappropriate prescribing and prescribing omissions. Polypharmacy was independently associated with both PPO and PIP. Application of such screening tools to prescribing decisions may reduce unnecessary medication, related adverse events, healthcare utilisation and cost.
Electronic supplementary material
The online version of this article (doi:10.1007/s00228-014-1651-8) contains supplementary material, which is available to authorized users.
PMCID: PMC3978378  PMID: 24493365
Potentially inappropriate prescribing; Potential prescribing omissions; STOPP; START; Older people
11.  Is the Timed Up and Go test a useful predictor of risk of falls in community dwelling older adults: a systematic review and meta- analysis 
BMC Geriatrics  2014;14:14.
The Timed Up and Go test (TUG) is a commonly used screening tool to assist clinicians to identify patients at risk of falling. The purpose of this systematic review and meta-analysis is to determine the overall predictive value of the TUG in community-dwelling older adults.
A literature search was performed to identify all studies that validated the TUG test. The methodological quality of the selected studies was assessed using the QUADAS-2 tool, a validated tool for the quality assessment of diagnostic accuracy studies. A TUG score of ≥13.5 seconds was used to identify individuals at higher risk of falling. All included studies were combined using a bivariate random effects model to generate pooled estimates of sensitivity and specificity at ≥13.5 seconds. Heterogeneity was assessed using the variance of logit transformed sensitivity and specificity.
Twenty-five studies were included in the systematic review and 10 studies were included in meta-analysis. The TUG test was found to be more useful at ruling in rather than ruling out falls in individuals classified as high risk (>13.5 sec), with a higher pooled specificity (0.74, 95% CI 0.52-0.88) than sensitivity (0.31, 95% CI 0.13-0.57). Logistic regression analysis indicated that the TUG score is not a significant predictor of falls (OR = 1.01, 95% CI 1.00-1.02, p = 0.05).
The Timed Up and Go test has limited ability to predict falls in community dwelling elderly and should not be used in isolation to identify individuals at high risk of falls in this setting.
PMCID: PMC3924230  PMID: 24484314
12.  A Prospective Cohort Study of Alcohol Exposure in Early and Late Pregnancy within an Urban Population in Ireland 
Most studies of alcohol consumption in pregnancy have looked at one time point only, often relying on recall. The aim of this longitudinal study was to determine whether alcohol consumption changes in early and late pregnancy and whether this affects perinatal outcomes. We performed a prospective cohort study, conducted from November 2010 to December 2011 at a teaching hospital in the Republic of Ireland. Of the 907 women with a singleton pregnancy who booked for antenatal care and delivered at the hospital, 185 (20%) abstained from alcohol in the first trimester but drank in the third trimester, 105 (12%) consumed alcohol in the first and third trimesters, and the remaining 617 (68%) consumed no alcohol in pregnancy. Factors associated with continuing to drink in pregnancy included older maternal age (30–39 years), Irish nationality, private healthcare, smoking, and a history of illicit drug use. Compared to pre-pregnancy, alcohol consumption in pregnancy was markedly reduced, with the majority of drinkers consuming ≤ 5 units per week (92% in first trimester, 72–75% in third trimester). Perhaps because of this, perinatal outcomes were similar for non-drinkers, women who abstained from alcohol in the first trimester, and women who drank in the first and third trimester of pregnancy. Most women moderate their alcohol consumption in pregnancy, especially in the first trimester, and have perinatal outcomes similar to those who abstain.
PMCID: PMC3945584  PMID: 24549147
alcohol exposure; prospective cohort study; pregnancy; perinatal outcomes
13.  Cochrane reviews: relevant more than ever 
PMCID: PMC3529257  PMID: 23336449
14.  Series introduction 
PMCID: PMC3529273  PMID: 23336462
15.  A retrospective cohort study of mode of delivery among public and private patients in an integrated maternity hospital setting 
BMJ Open  2013;3(11):e003865.
To examine the associations between mode of delivery and public versus privately funded obstetric care within the same hospital setting.
Retrospective cohort study.
Urban maternity hospital in Ireland.
A total of 30 053 women with singleton pregnancies who delivered between 2008 and 2011.
The study population was divided into those who booked for obstetric care within the public (n=24 574) or private clinics (n=5479). Logistic regression analyses were performed to examine the associations between operative delivery and type of care, adjusting for potential confounding factors.
Main outcome measures
Caesarean section (scheduled or emergency), operative vaginal delivery (vacuum or forceps), indication for caesarean section as classified by the operator.
Compared with public patients, private patients were more likely to be delivered by caesarean section (34.4% vs 22.5%, OR 1.81; 95% CI 1.70 to 1.93) or operative vaginal delivery (20.1% vs 16.5%, OR 1.28; 95% CI 1.19 to 1.38). The greatest disparity was for scheduled caesarean sections; differences persisted for nulliparous and parous women after controlling for medical and social differences between the groups (nulliparous 11.9% vs 4.6%, adjusted (adj) OR 1.82; 95% CI 1.49 to 2.24 and parous 26% vs 12.2%, adj OR 2.08; 95% CI 1.86 to 2.32). Scheduled repeat caesarean section accounted for most of the disparity among parous patients. Maternal request per se was an uncommonly reported indication for caesarean section (35 in each group, p<0.000).
Privately funded obstetric care is associated with higher rates of operative deliveries that are not fully accounted for by medical or obstetric risk differences.
PMCID: PMC3840346  PMID: 24277646
Cohort Study; Operative Delivery; Caesarean Section; Private Healthcare; Operative Vaginal Delivery
16.  Prescribing patterns of glucosamine in an older population: a national cohort study 
Glucosamine is commonly prescribed as a disease modulating agent in osteoarthritis. However, the evidence to date suggests that it has a limited impact on the clinical symptoms of the disease including joint pain, radiological progression, function and quality of life. The aim of this study was to examine the prescribing patterns of glucosamine from 2002–2011 in an elderly Irish national population cohort using data from the Health Service Executive Primary Care Reimbursement (HSE-PCRS) General medical services (GMS) Scheme.
Patients aged ≥ 70 years on the HSE-PCRS pharmacy claims database between January 2002 and December 2011 were included. ATC code M01AX05 (glucosamine) was extracted. Prevalence rates per 1000 eligible population with 95% confidence intervals were calculated for all years and age groups (70–74 years, ≥75 years). A negative binomial regression analysis was used to determine longitudinal usage trends and compare prevalence rates across years, sex and age groups.
The annual patient rate of glucosamine prescribing increased significantly from 13.0/1000 eligible population (95% CI 12.6-13.4) in 2002 to 68.7/1000 population (95% CI 67.8-69.5) in 2009 before decreasing to 62.4/1000 population (95% CI 61.6-63.2) in 2011. The rate of prescribing of glucosamine varied with sex, with women receiving significantly more prescriptions than men. The cost of glucosamine also increased from 2002–2008. In 2008 total expenditure reached a high of €4.6 million before decreasing to €2.6 million in 2011.
The national trend in prescribing of glucosamine increased significantly from 2002 to 2009 before decreasing in 2010 and 2011, in keeping with current international guidelines. There is a need for awareness among healthcare professionals and patients alike of the best available evidence to inform decision making relating to the prescription and consumption of such supplements.
PMCID: PMC3874622  PMID: 24219123
Osteoarthritis; Glucosamine; Cost-effectiveness
17.  Addressing potentially inappropriate prescribing in older patients: development and pilot study of an intervention in primary care (the OPTI-SCRIPT study) 
Potentially inappropriate prescribing (PIP) in older people is common in primary care and can result in increased morbidity, adverse drug events, hospitalizations and mortality. The prevalence of PIP in Ireland is estimated at 36% with an associated expenditure of over €45 million in 2007. The aim of this paper is to describe the application of the Medical Research Council (MRC) framework to the development of an intervention to decrease PIP in Irish primary care.
The MRC framework for the design and evaluation of complex interventions guided the development of the study intervention. In the development stage, literature was reviewed and combined with information obtained from experts in the field using a consensus based methodology and patient cases to define the main components of the intervention. In the pilot stage, five GPs tested the proposed intervention. Qualitative interviews were conducted with the GPs to inform the development and implementation of the intervention for the main randomised controlled trial.
The literature review identified PIP criteria for inclusion in the study and two initial intervention components - academic detailing and medicines review supported by therapeutic treatment algorithms. Through patient case studies and a focus group with a group of 8 GPs, these components were refined and a third component of the intervention identified - patient information leaflets. The intervention was tested in a pilot study. In total, eight medicine reviews were conducted across five GP practices. These reviews addressed ten instances of PIP, nine of which were addressed in the form of either a dose reduction or a discontinuation of a targeted medication. Qualitative interviews highlighted that GPs were receptive to the intervention but patient preference and time needed both to prepare for and conduct the medicines review, emerged as potential barriers. Findings from the pilot study allowed further refinement to produce the finalised intervention of academic detailing with a pharmacist, medicines review with web-based therapeutic treatment algorithms and tailored patient information leaflets.
The MRC framework was used in the development of the OPTI-SCRIPT intervention to decrease the level of PIP in primary care in Ireland. Its application ensured that the intervention was developed using the best available evidence, was acceptable to GPs and feasible to deliver in the clinical setting. The effectiveness of this intervention is currently being tested in a pragmatic cluster randomised controlled trial.
Trial registration
Current controlled trials ISRCTN41694007
PMCID: PMC3751793  PMID: 23941110
Medical research council framework; Multifaceted intervention; Potentially inappropriate prescribing; Randomised controlled trial
18.  Cardiovascular medication: improving adherence 
BMJ Clinical Evidence  2011;2011:0220.
Adherence to medication is generally defined as the extent to which people take medications as prescribed by their healthcare providers. It can be assessed in many ways (e.g., by self-reporting, pill counting, direct observation, electronic monitoring, or by pharmacy records). This review reports effects of intervention on adherence to cardiovascular medications however adherence has been measured.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of interventions to improve adherence to long-term medication for cardiovascular disease in adults? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
We found 39 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
In this systematic review we present information relating to the effectiveness and safety of the following interventions: patient health education, prescriber education, prompting mechanisms, reminder packaging (calendar [blister] packs, multi-dose pill boxes), and simplified dosing.
Key Points
Adherence to medication is generally defined as the extent to which people take medications as prescribed by their healthcare providers. It can be assessed in many ways (e.g., by self-reporting, pill counting, direct observation, electronic monitoring, or through pharmacy records). In this review, we have reported adherence to cardiovascular medications however it has been measured.
The RCTs we found used a variety of different interventions in different populations, measured adherence differently, and expressed and analysed results differently. The diversity and complexity of interventions employed in RCTs makes it difficult to separate out any individual components that might be of benefit.
We found evidence that simplified dosing regimens may increase adherence compared with more complex regimens. While simplifying the frequency of dosage may increase adherence, it is not known whether simplified regimens may increase adherence when someone is taking multiple drugs, as may be the case with cardiovascular medicines.In altering a drug regimen simply to increase adherence, any changes could potentially affect the effectiveness of the treatment, and could also potentially increase adverse effects.
Prompting mechanisms may also increase adherence to medication. Some prompting mechanisms may be simple and inexpensive (e.g., mailed reminders), while others (e.g., daily telephone calls, installing videophones) seem impracticable for use in routine practice.
Patient health education may also increase adherence to medication but more data are needed to draw conclusions. Adherence behaviour is complex. Traditional education methods may fail to address this. However, more patient-centred approaches, particularly those that are nurse- or pharmacist-led, using video or telephone strategies, may be beneficial and require further investigation. We found some evidence that a combination of strategies, such as education plus prompting, may be more successful than a single educational strategy.
We found no evidence from one RCT that reminder packaging (a calendar blister pack) was effective, and found insufficient evidence on other types of reminder packaging such as multi-dose pill boxes.
We found one RCT of prescriber education in a developing country, which showed that a 1-day intensive training session of general practitioners on hypertension improved medication adherence compared with usual care but these data are not generalisable to the range of people taking cardiovascular medication so we cannot draw firm conclusions about this intervention.
PMCID: PMC3217775  PMID: 21481286
19.  Cemented versus uncemented fixation in total hip replacement: a systematic review and meta-analysis of randomized controlled trials 
Orthopedic Reviews  2013;5(1):e8.
The optimal method of fixation for primary total hip replacements (THR), particularly fixation with or without the use of cement is still controversial. In a systematic review and metaanalysis of all randomized controlled trials comparing cemented versus uncemented THRS available in the published literature, we found that there is no significant difference between cemented and uncemented THRs in terms of implant survival as measured by the revision rate. Better short-term clinical outcome, particularly an improved pain score can be obtained with cemented fixation. However, the results are unclear for the long-term clinical and functional outcome between the two groups. No difference was evident in the mortality and the post operative complication rate. On the other hand, the radiographic findings were variable and do not seem to correlate with clinical findings as differences in the surgical technique and prosthesis design might be associated with the incidence of osteolysis. We concluded in our review that cemented THR is similar if not superior to uncemented THR, and provides better short term clinical outcomes. Further research, improved methodology and longer follow up are necessary to better define specific subgroups of patients in whom the relative benefits of cemented and uncemented implant fixation can be clearly demonstrated.
PMCID: PMC3662257  PMID: 23705066
cemented; uncemented; total hip arthroplasty; meta analysis.
20.  Effectiveness of medicines review with web-based pharmaceutical treatment algorithms in reducing potentially inappropriate prescribing in older people in primary care: a cluster randomized trial (OPTI-SCRIPT study protocol) 
Trials  2013;14:72.
Potentially inappropriate prescribing in older people is common in primary care and can result in increased morbidity, adverse drug events, hospitalizations and mortality. In Ireland, 36% of those aged 70 years or over received at least one potentially inappropriate medication, with an associated expenditure of over €45 million.
The main objective of this study is to determine the effectiveness and acceptability of a complex, multifaceted intervention in reducing the level of potentially inappropriate prescribing in primary care.
This study is a pragmatic cluster randomized controlled trial, conducted in primary care (OPTI-SCRIPT trial), involving 22 practices (clusters) and 220 patients. Practices will be allocated to intervention or control arms using minimization, with intervention participants receiving a complex multifaceted intervention incorporating academic detailing, medicines review with web-based pharmaceutical treatment algorithms that provide recommended alternative treatment options, and tailored patient information leaflets. Control practices will deliver usual care and receive simple patient-level feedback on potentially inappropriate prescribing. Routinely collected national prescribing data will also be analyzed for nonparticipating practices, acting as a contemporary national control. The primary outcomes are the proportion of participant patients with potentially inappropriate prescribing and the mean number of potentially inappropriate prescriptions per patient. In addition, economic and qualitative evaluations will be conducted.
This study will establish the effectiveness of a multifaceted intervention in reducing potentially inappropriate prescribing in older people in Irish primary care that is generalizable to countries with similar prescribing challenges.
Trial registration
Current controlled trials ISRCTN41694007
PMCID: PMC3621288  PMID: 23497575
Multifaceted intervention; Potentially inappropriate prescribing; Primary care; Randomized controlled trial
21.  Protocol for a systematic review and individual patient data meta-analysis of prognostic factors of foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS) 
Diabetes–related lower limb amputations are associated with considerable morbidity and mortality and are usually preceded by foot ulceration. The available systematic reviews of aggregate data are compromised because the primary studies report both adjusted and unadjusted estimates. As adjusted meta-analyses of aggregate data can be challenging, the best way to standardise the analytical approach is to conduct a meta-analysis based on individual patient data (IPD).
There are however many challenges and fundamental methodological omissions are common; protocols are rare and the assessment of the risk of bias arising from the conduct of individual studies is frequently not performed, largely because of the absence of widely agreed criteria for assessing the risk of bias in this type of review. In this protocol we propose key methodological approaches to underpin our IPD systematic review of prognostic factors of foot ulceration in diabetes.
Review questions;
1. What are the most highly prognostic factors for foot ulceration (i.e. symptoms, signs, diagnostic tests) in people with diabetes?
2. Can the data from each study be adjusted for a consistent set of adjustment factors?
3. Does the model accuracy change when patient populations are stratified according to demographic and/or clinical characteristics?
MEDLINE and EMBASE databases from their inception until early 2012 were searched and the corresponding authors of all eligible primary studies invited to contribute their raw data. We developed relevant quality assurance items likely to identify occasions when study validity may have been compromised from several sources. A confidentiality agreement, arrangements for communication and reporting as well as ethical and governance considerations are explained.
We have agreement from the corresponding authors of all studies which meet the eligibility criteria and they collectively possess data from more than 17000 patients. We propose, as a provisional analysis plan, to use a multi-level mixed model, using “study” as one of the levels. Such a model can also allow for the within-patient clustering that occurs if a patient contributes data from both feet, although to aid interpretation, we prefer to use patients rather than feet as the unit of analysis. We intend to only attempt this analysis if the results of the investigation of heterogeneity do not rule it out and the model diagnostics are acceptable.
This review is central to the development of a global evidence-based strategy for the risk assessment of the foot in patients with diabetes, ensuring future recommendations are valid and can reliably inform international clinical guidelines.
PMCID: PMC3599337  PMID: 23414550
22.  Behavioural change in relation to alcohol exposure in early pregnancy and impact on perinatal outcomes - a prospective cohort study 
There has been limited research addressing whether behavioural change in relation to alcohol exposure in pregnancy results in better perinatal outcomes.
A cohort study of 6725 women who booked for antenatal care and delivered in a large urban teaching hospital in 2010–2011. A detailed history of alcohol consumption pre-pregnancy and during early pregnancy was recorded at the first antenatal visit with follow-up of the mother and infant until discharge following birth. Adverse perinatal outcomes were compared for ‘non-drinkers’, ‘ex-drinkers’ and ‘current drinkers’.
Of the 6017 (90%) women who reported alcohol consumption prior to pregnancy 3325 (55%) engaged in binge drinking and 266 (4.4%) consumed more than 14 units on average per week. At the time of booking 5649 (94%) women were ex-drinkers and of the 368 women who continued to drink 338 (92%) had a low intake (0–5 units per week), 30 (8%) an excess intake (6-20+ units per week) and 93 (25%) reported at least one episode of binge drinking. Factors associated with continuing to drink in early pregnancy included older maternal age (30–39 years), (OR 1.6; 95% CI 1.3 to 1.8), Irish nationality (OR 3.1; 95% CI 2.2 to 4.3) and smoking (OR 2.6; 95% CI 1.9 to 3.5). Ex-drinkers had similar perinatal outcomes to non-drinkers. Compared to non-drinkers current drinking was associated with an increased risk of intrauterine growth restriction (IUGR) (13% versus 19%, crude OR 1.6; 95% CI 1.1 to 2.2, adjusted OR 1.2; 95% CI 0.8 to 1.8). The greatest risk of IUGR was among women who continued to both drink and smoke, (9% versus 32%, crude OR 4.8; 95% CI 3.3 to 7.0, adjusted OR 4.5; 95% CI 3.1 to 6.7).
Public Health campaigns need to emphasise the potential health gains of abstaining from both alcohol and smoking in pregnancy.
PMCID: PMC3549282  PMID: 23324650
Alcohol exposure; Prospective cohort study; Pregnancy; Perinatal outcomes
23.  Proton pump inhibitors: potential cost reductions by applying prescribing guidelines 
There are concerns that proton pump inhibitors (PPI) are being over prescribed in both primary and secondary care. This study aims to establish potential cost savings in a community drug scheme for a one year period according to published clinical and cost-effective guidelines for PPI prescribing.
Retrospective population-based cohort study in the Republic of Ireland using the Health Services Executive (HSE) Primary Care Reimbursement Services (PCRS) pharmacy claims database. The HSE-PCRS scheme is means tested and provides free health care including medications to approximately 30% of the Irish population. Prescription items are WHO ATC coded and details of every drug dispensed and claimants’ demographic data are available. Potential cost savings (net ingredient cost) were estimated according to UK NICE clinical guidelines for all HSE-PCRS claimants on PPI therapy for ≥3 consecutive months starting in 2007 with a one year follow up (n=167,747). Five scenarios were evaluated; (i) change to PPI initiation (cheapest brand); and after 3 months (ii) therapeutic switching (cheaper brand/generic equivalent); (iii) dose reduction (maintenance therapy); (iv) therapeutic switching and dose reduction and (v) therapeutic substitution (H2 antagonist).
Total net ingredient cost was €88,153,174 for claimants on PPI therapy during 2007. The estimated costing savings for each of the five scenarios in a one year period were: (i) €36,943,348 (42% reduction); (ii) €29,568,475 (34%); (iii) €21,289,322 (24%); (iv) €40,505,013 (46%); (v) €34,991,569 (40%).
There are opportunities for substantial cost savings in relation to PPI prescribing if implementation of clinical guidelines in terms of generic substitution and step-down therapy is implemented on a national basis.
PMCID: PMC3529111  PMID: 23163956
Proton pump inhibitors; Cost-effective; Guidelines; Generic
25.  Diagnostic accuracy of the STRATIFY clinical prediction rule for falls: A systematic review and meta-analysis 
BMC Family Practice  2012;13:76.
The STRATIFY score is a clinical prediction rule (CPR) derived to assist clinicians to identify patients at risk of falling. The purpose of this systematic review and meta-analysis is to determine the overall diagnostic accuracy of the STRATIFY rule across a variety of clinical settings.
A literature search was performed to identify all studies that validated the STRATIFY rule. The methodological quality of the studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool. A STRATIFY score of ≥2 points was used to identify individuals at higher risk of falling. All included studies were combined using a bivariate random effects model to generate pooled sensitivity and specificity of STRATIFY at ≥2 points. Heterogeneity was assessed using the variance of logit transformed sensitivity and specificity.
Seventeen studies were included in our meta-analysis, incorporating 11,378 patients. At a score ≥2 points, the STRATIFY rule is more useful at ruling out falls in those classified as low risk, with a greater pooled sensitivity estimate (0.67, 95% CI 0.52–0.80) than specificity (0.57, 95% CI 0.45 – 0.69). The sensitivity analysis which examined the performance of the rule in different settings and subgroups also showed broadly comparable results, indicating that the STRATIFY rule performs in a similar manner across a variety of different ‘at risk’ patient groups in different clinical settings.
This systematic review shows that the diagnostic accuracy of the STRATIFY rule is limited and should not be used in isolation for identifying individuals at high risk of falls in clinical practice.
PMCID: PMC3460792  PMID: 22870921
Falls assessment; STRATIFY; Sensitivity and specificity; Systematic review; Meta-analysis

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