Renal Denervation as a Complementary Treatment Option for Uncontrolled Arterial Hypertension: A Situation Assessment.

Uncontrolled arterial hypertension is a major global health issue. Catheter-based renal denervation has shown to lower blood pressure in sham-controlled trials and represents a device-based, complementary treatment option for hypertension. In this situation assessment, the authors, who are practicing experts in hypertension, nephrology, general practice and cardiology in the Republic of Ireland, discuss the current evidence base for the BP-lowering efficacy and safety of catheter-based renal denervation with different modalities. Although important questions remain regarding the identification of responders, and long-term efficacy and safety of the intervention, renal denervation has the potential to provide much-needed help to address hypertension and its adverse consequences. The therapeutic approach needs to be multidisciplinary and personalised to take into account the perspective of patients and healthcare professionals in a shared decision-making process.

The Limerick Declaration on Rural Health Care 2022.

The 19th World Rural Health Conference, hosted in rural Ireland and the University of Limerick, with over 650 participants coming from 40 countries and an additional 1600 engaging online, has carefully considered how best rural communities can be empowered to improve their own health and the health of those around them. The conference also considered the role of national health systems and all stakeholders, in keeping with the commitments made through the Sustainable Development Goals and the enjoyment of the highest attainable standard of health as one of the fundamental rights of every human being. This conference declaration, the Limerick Declaration on Rural Healthcare, is designed to inform rural communities, academics and policymakers about how to achieve the goal of delivering high quality health care in rural and remote areas most effectively, with a particular focus on the Irish healthcare system. Congruent with current evidence and best international practice, the participants of the conference endorsed a series of recommendations for the creation of high quality, sustainable and cost-effective healthcare delivery for rural communities in Ireland and globally. The recommendations focused on four major themes: rural healthcare needs and delivery, rural workforce, advocacy and policy, and research for rural health care. Equal access to health care is a crucial marker of democracy. Hence, we call on all governments, policymakers, academic institutions and communities globally to commit to providing their rural dwellers with equitable access to health care that is properly resourced and fundamentally patient-centred in its design.

The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial.

BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MultimorbiditY Collaborative Medication Review And Decision Making (MyComrade) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)). METHODS: A pilot cluster randomised controlled trial will be conducted, using a mixed-methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention based on pre-defined progression criteria. A total of 16 practices will be recruited (eight in ROI; eight in NI), and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥ 10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of general practitioners (GPs) in ROI, and a GP and practice-based pharmacist (PBP) in NI. The GPs/GP and PBP will schedule the time to review the medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment and 4 and 8 months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed. DISCUSSION: The findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN80017020 . Date of confirmation is 4/11/2019.

Systematic review of interventions to improve gender equity in graduate medicine.

Women are substantially underrepresented in senior and leadership positions in medicine and experience gendered challenges in their work settings. This systematic review aimed to synthesise research that has evaluated interventions for improving gender equity in medicine. English language electronic searches were conducted across MEDLINE, CINAHL, Academic Search Complete, PsycINFO and Web of Science. Reference list screening was also undertaken. Peer-reviewed studies published between 2000 and March 2020 that evaluated interventions to improve gender equity, or the experiences of women, in academic or clinical medicine were reviewed. Dual reviewer data extraction on setting, participants, type of intervention, measurement and outcomes was completed. Methodological rigour and strength of findings were evaluated. In total, 34 studies were included. Interventions were typically focused on equipping the woman (82.4%), that is, delivering professional development activities for women. Fewer focused on changing cultures (20.6%), ensuring equal opportunities (23.5%) or increasing the visibility or valuing of women (23.5%). Outcomes were largely positive (87.3%) but measurement typically relied on subjective, self-report data (69.1%). Few interventions were implemented in clinical settings (17.6%). Weak methodological rigour and a low strength of findings was observed. There has been a focus to-date on interventions which Equip the Woman Interventions addressing systems and culture change require further research consideration. However, institutions cannot wait on high quality research evidence to emerge to take action on gender equity. Data collated suggest a number of recommendations pertaining to research on, and the implementation of, interventions to improve gender equity in academic and clinical settings.

A Systematic Review of Measurement Tools for the Proactive Assessment of Patient Safety in General Practice.

BACKGROUND: Primary care physicians have reported a difficulty in understanding how best to measure and improve patient safety in their practices. OBJECTIVES: The aims of the study were to identify measures of patient safety suitable for use in primary care and to provide guidance on proactively monitoring and measuring safety. METHODS: Searches were conducted using Medline, Embase, CINAHL and PsycInfo in February 2016. Studies that used a measure assessing levels of or attitudes toward patient safety in primary care were considered for inclusion. Only studies describing tools focused on the proactive assessment of safety were reviewed. Two independent reviewers extracted data from articles and applied the Quality Assessment Tool for Studies with Diverse Designs. RESULTS: More than 2800 studies were screened, of which 56 were included. Most studies had used healthcare staff survey or interviews to assess patient safety (n = 34), followed by patient chart audit (n = 14) or use of a practice assessment checklist (n = 7). Survey or interview of patients, active monitoring systems, and simulated patients were used with less frequency. CONCLUSIONS: A lack of appropriate measurement tools has been suggested to limit the ability to monitor patient safety in primary care and to improve patient care. There is no evident "best" method of measuring patient safety in primary care. However, many of the measures are readily available, quick to administer, do not require external involvement, and are inexpensive. This synthesis of the literature suggests that it is possible for primary care physicians to take a proactive approach to measuring and improving safety.

Blood pressure control in patients with a previous stroke/transient ischaemic attack in primary care in Ireland: a cross sectional study.

BACKGROUND: Uncontrolled blood pressure (BP) is an important modifiable risk factor for recurrent stroke. Secondary prevention measures when implemented can reduce stroke re-occurrence by 80%. However, hypertension control rates remain sub-optimal, and little data is available from primary care where most management occurs. The aim of this study was to describe BP control in primary care-based patients with a previous stroke or transient ischaemic attack (TIA) in Ireland, and to concurrently examine antihypertensive medication-dosing. METHODS: Study participants most recent office-based BP reading was compared with the NICE (NG136) and European Society of Hypertension/ European Society of Cardiology (ESH/ESC 2013) goal of BP < 140/90 mmHg. Optimal anti-hypertensive medication dosing was determined by benchmarking prescribed doses for each drug with the World Health Organisation-Defined Daily Dosing (WHO-DDD) recommendations. RESULTS: We identified 328 patients with a previous stroke or TIA in 10 practices. Blood pressure was controlled in almost two thirds of patients when measured against the ESH/ESC and NICE guidelines (63.1%, n = 207). Of those with BP ≥140/90 (n = 116), just under half (n = 44, 47.3%) were adequately dosed in all anti-hypertensive medications when compared with the WHO-DDD recommendations. CONCLUSION: Blood pressure control in patients post stroke/TIA appears sub-optimal in over one third of patients. A comparison of drug doses with WHO-DDD recommendations suggests that 47% of patients may benefit from drug-dose improvements. Further work is required to assess how best to manage blood pressure in patients with a previous stroke or TIA in Primary Care, as most consultations for hypertension take place in this setting.

The CHARMS pilot study: a multi-method assessment of the feasibility of a sexual counselling implementation intervention in cardiac rehabilitation in Ireland.

BACKGROUND: Many people living with cardiovascular disease (CVD) are affected by sexual problems associated with the condition. International guidelines recommend all patients with CVD should receive sexual counselling, yet this is rarely provided by health professionals. The current study piloted the Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention, a complex multi-level intervention designed to increase the implementation of sexual counselling guidelines in hospital-based cardiac rehabilitation (CR) in Ireland. METHODS: The CHARMS intervention, consisting of awareness training and skills development for staff, and education and support for patients, was implemented in two CR centres. Following a repeated measures design, quantitative and qualitative feasibility, fidelity, cost, and outcome data were collected from staff and patients at baseline (T1, pre-intervention), at 3 months post-baseline (T2, post-intervention), and at 6 months post-baseline (T3, post-intervention). Data were organised according to a 14-point reporting framework of methodological issues that should be examined in pilot and feasibility studies. To inform a future definitive trial, potential solutions to identified feasibility issues were generated using the ADePT process for decision-making after pilot and feasibility trials. RESULTS: Most elements of the study protocol were executed smoothly, and intervention implementation was successful. Patients' (N = 42) responses to the intervention were positive. The reporting framework and the ADePT process facilitated the identification of two overarching feasibility problems, as well as solutions to be implemented in a definitive trial: (1) a high level of patient attrition in the pilot study, to be addressed through the use of financial incentives, reducing the length of the patient questionnaire, and providing a telephone survey option; and (2) negative staff perceptions, to be addressed through an augmented staff intervention, reframing 'sexual counselling' as 'sexual education and support' to fit with professional role perceptions, and reviewing all intervention terminology with a CR staff member to ensure acceptability. CONCLUSIONS: This article reports the successful piloting of a novel sexual counselling implementation intervention in cardiac rehabilitation. The utilisation of an extended reporting framework and the ADePT process facilitated the identification of adaptations necessary to ensure the feasibility of a definitive trial, thereby maximising methodological transparency.

Out-of-hospital cardiac arrest in the home: Can area characteristics identify at-risk communities in the Republic of Ireland?

BACKGROUND: Internationally, the majority of out-of-hospital cardiac arrests where resuscitation is attempted (OHCAs) occur in private residential locations i.e. at home. The prospect of survival for this patient group is universally dismal. Understanding of the area-level factors that affect the incidence of OHCA at home may help national health planners when implementing community resuscitation training and services. METHODS: We performed spatial smoothing using Bayesian conditional autoregression on case data from the Irish OHCA register. We further corrected for correlated findings using area level variables extracted and constructed for national census data. RESULTS: We found that increasing deprivation was associated with increased case incidence. The methodology used also enabled us to identify specific areas with higher than expected case incidence. CONCLUSIONS: Our study demonstrates novel use of Bayesian conditional autoregression in quantifying area level risk of a health event with high mortality across an entire country with a diverse settlement pattern. It adds to the evidence that the likelihood of OHCA resuscitation events is associated with greater deprivation and suggests that area deprivation should be considered when planning resuscitation services. Finally, our study demonstrates the utility of Bayesian conditional autoregression as a methodological approach that could be applied in any country using registry data and area level census data.

Long-term cost effectiveness of cardiac secondary prevention in primary care in the Republic of Ireland and Northern Ireland.

While cardiac secondary prevention in primary care is established practice, little is known about its long-term cost effectiveness. This study examines the cost effectiveness of a secondary prevention intervention in primary care in the Republic of Ireland and Northern Ireland over 6 years. An economic evaluation, based on a cluster randomised controlled trial of 903 patients with heart disease, was conducted 4.5 years after the intervention ceased to be delivered. Patients originally randomised to the control received usual practice while those randomised to the intervention received a tailored care package over the 1.5-year delivery period. Data on healthcare costs and quality adjusted life expectancy were used to undertake incremental cost utility analysis. Multilevel regression was used to estimate mean cost effectiveness and uncertainty was examined using cost effectiveness acceptability curves. At 6 years, there was a divergence in the results across jurisdictions. While the probability of the intervention being cost effective in the Republic of Ireland was 0.434, 0.232, 0.180, 0.150, 0.115 and 0.098 at selected threshold values of €5000, €15,000, €20,000, €25,000, €35,000 and €45,000, respectively, all equivalent probabilities for Northern Ireland equalled 1.000. Our findings suggest that the intervention in its current format is likely to be more cost effective than usual general practice care in Northern Ireland, but this is not the case in the Republic of Ireland.

The cost effectiveness of the SIMPle intervention to improve antimicrobial prescribing for urinary tract infection in primary care.

Background: Antimicrobial resistance is a major public health issue. This study examines the cost effectiveness of the SIMPle (Supporting the Improvement and Management of Prescribing for Urinary Tract Infections (UTI)) intervention to improve antimicrobial prescribing in primary care in Ireland. Methods: An economic evaluation was conducted alongside a cluster randomized controlled trial of 30 general practices and 2560 patients with a diagnosis of UTI. Practices were randomized to the usual practice control or the SIMPle intervention (arm A or B). Data at 6 months follow-up were used to estimate incremental costs, incremental effectiveness in terms of first-line antimicrobial prescribing for UTI and cost effectiveness acceptability curves. Results: The SIMPle intervention was, on average, more costly and more effective than the control. The probability of intervention arm A being cost effective was 0.280, 0.995 and 1.000 at threshold values of €50, €150 and €250 per percentage point increase in first-line antimicrobial prescribing respectively. The equivalent probabilities for intervention arm B were 0.121, 0.863 and 0.985, respectively. Conclusions: The cost effectiveness of the SIMPle intervention depends on the value placed on improving antimicrobial prescribing. Future studies should examine the wider and longer term costs and outcomes of improving antimicrobial prescribing.

A comparison of medical records and patient questionnaires as sources for the estimation of costs within research studies and the implications for economic evaluation.

BACKGROUND: Data on health care utilization may be collected using a variety of mechanisms within research studies, each of which may have implications for cost and cost effectiveness. OBJECTIVE: The aim of this observational study is to compare data collected from medical records searches and self-report questionnaires for the cost analysis of a cardiac secondary prevention intervention. METHODS: Secondary data analysis of the Secondary Prevention of Heart Disease in General Practice (SPHERE) randomized controlled trial (RCT). Resource use data for a range of health care services were collected by research nurse searches of medical records and self-report questionnaires and costs of care estimated for each data collection mechanism. A series of statistical analyses were conducted to compare the mean costs for medical records data versus questionnaire data and to conduct incremental analyses for the intervention and control arms in the trial. RESULTS: Data were available to estimate costs for 95% of patients in the intervention and 96% of patients in the control using the medical records data compared to 65% and 66%, respectively, using the questionnaire data. The incremental analysis revealed a statistically significant difference in mean cost of -€796 (95% CI: -1447, -144; P-value: 0.017) for the intervention relative to the control. This compared to no significant difference in mean cost (95% CI: -1446, 860; P-value: 0.619) for the questionnaire analysis. CONCLUSIONS: Our findings illustrate the importance of the choice of health care utilization data collection mechanism for the conduct of economic evaluation alongside randomized trials in primary care. This choice will have implications for the costing methodology employed and potentially, for the cost and cost effectiveness outcomes generated.

Prescription contraception use: a cross-sectional population study of psychosocial determinants.

OBJECTIVE: Many forms of contraception are available on prescription only for example, the oral contraceptive pill (OCP) and long-acting reversible contraceptives (LARCs). In this analysis we aim to identify key determinants of prescription contraceptive use. DESIGN: Cross-sectional population survey. Data on sociodemographic indices, concerns about the OCP and perceived barriers to access were collected. SETTING: Data set constructed from a representative population-based telephone survey of community dwelling adults in the Republic of Ireland (RoI) PARTICIPANTS: 1515 women aged between 18 and 45 years MAIN OUTCOME MEASURE: Self-reported user of the OCP or LARCs (intrauterine contraception, contraceptive injections or subdermal contraceptive implants) in the previous 12 months. RESULTS: For at least some of the previous year, 35% had used the OCP and 14% had used LARCs, while 3% had used two or more of these methods. OCP users were significantly younger, more likely to be unmarried and had higher income than non-users. Overall, 68% agreed with the statement 'that taking a break from long-term use of the contraceptive pill is a good idea' and 37% agreed with the statement that 'the OCP has dangerous side effects' and this was the strongest predictor variable of non-use of the OCP. Intrauterine contraception users were significantly older, more likely to be married and had lower income than non-users. Injections or subdermal contraceptive implant users were significantly younger, less likely to be married, had lower income and were less likely to agree that taking a break from long-term use of the pill is a good idea than non-users. CONCLUSIONS: Prescription contraceptive use is sociodemographically patterned, with LARCs in particular being associated with lower incomes in the RoI. Concerns about the safety of the OCP remain prevalent and are important and modifiable determinants of contraceptive-related behaviour.

Comparing the clinical-effectiveness and cost-effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: study protocol for a randomised controlled trial.

INTRODUCTION: Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence-based psychological treatment in the Irish health service context. While the use of internet-delivered cognitive-behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain, there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) programme among people with chronic pain. The current study will compare the clinical-effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain. METHODS AND ANALYSIS: Participants with non-malignant pain that persists for at least 3 months will be randomised to one of two study conditions. The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period. The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period. Participants will be assessed preintervention, postintervention and at a 3-month follow-up. The primary outcome will be pain-related functional interference. Secondary outcomes will include: pain intensity, depression, global impression of change, acceptance of chronic pain and quality of life. A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial. ETHICS AND DISSEMINATION: The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee (12/05/05). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN18166896.

Effectiveness of a smartphone application to promote physical activity in primary care: the SMART MOVE randomised controlled trial.

BACKGROUND: Physical inactivity is a major, potentially modifiable, risk factor for cardiovascular disease, cancer, and other chronic diseases. Effective, simple, and generalisable interventions that will increase physical activity in populations are needed. AIM: To evaluate the effectiveness of a smartphone application (app) to increase physical activity in primary care. DESIGN AND SETTING: An 8-week, open-label, randomised controlled trial in rural, primary care in the west of Ireland. METHOD: Android smartphone users >16 years of age were recruited. All participants were provided with similar physical activity goals and information on the benefits of exercise. The intervention group was provided with a smartphone app and detailed instructions on how to use it to achieve these goals. The primary outcome was change in physical activity, as measured by a daily step count between baseline and follow-up. RESULTS: A total of 139 patients were referred by their primary care health professional or self-referred. In total, 37 (27%) were screened out and 12 (9%) declined to participate, leaving 90 (65%) patients who were randomised. Of these, 78 provided baseline data (intervention = 37; control = 41) and 77 provided outcome data (intervention = 37; control = 40). The mean daily step count at baseline for intervention and control groups was 4365 and 5138 steps per day respectively. After adjusting, there was evidence of a significant treatment effect (P = 0.009); the difference in mean improvement in daily step count from week 1 to week 8 inclusive was 1029 (95% confidence interval 214 to 1843) steps per day, favouring the intervention. Improvements in physical activity in the intervention group were sustained until the end of the trial. CONCLUSION: A simple smartphone app significantly increased physical activity over 8 weeks in a primary care population.

Patients' experiences of using a smartphone application to increase physical activity: the SMART MOVE qualitative study in primary care.

BACKGROUND: Regular physical activity is known to help prevent and treat numerous non-communicable diseases. Smartphone applications (apps) have been shown to increase physical activity in primary care but little is known regarding the views of patients using such technology or how such technology may change behaviour. AIM: To explore patients' views and experiences of using smartphones to promote physical activity in primary care. DESIGN AND SETTING: This qualitative study was embedded within the SMART MOVE randomised controlled trial, which used an app (Accupedo-Pro Pedometer) to promote physical activity in three primary care centres in the west of Ireland. METHOD: Taped and transcribed semi-structured interviews with a purposeful sample of 12 participants formed the basis of the investigation. Framework analysis was used to analyse the data. RESULTS: Four themes emerged from the analysis: transforming relationships with exercise; persuasive technology tools; usability; and the cascade effect. The app appeared to facilitate a sequential and synergistic process of positive change, which occurred in the relationship between the participants and their exercise behaviour; the study has termed this the 'Know-Check-Move' effect. Usability challenges included increased battery consumption and adjusting to carrying the smartphone on their person. There was also evidence of a cascade effect involving the families and communities of participants. CONCLUSION: Notwithstanding technological challenges, an app has the potential to positively transform, in a unique way, participants' relationships with exercise. Such interventions can also have an associated cascade effect within their wider families and communities.

Views of doctors of varying disciplines on HPAT-Ireland as a selection tool for medicine.

BACKGROUND: Selection tools for medicine must achieve political validity and enjoy stakeholder acceptability. This qualitative study aimed to establish the perspectives of doctors, from various clinical specialities, on HPAT-Ireland, a new selection tool for undergraduate medical students. METHODS: Fifteen doctors participated over three iterative cycles of recruitment, interviewing and analysis. Prior to interview, participants sat a practice HPAT-Ireland test. HPAT-Ireland has three sections: (1) Logical reasoning/problem solving; (2) Interpersonal understanding and (3): Non-verbal reasoning. SUMMARY OF RESULTS: Three themes emerged: job relatedness; utility of HPAT-Ireland and diversity. Sections 1 and 2 were considered very job related however Section 3 was widely criticised for lacking clinical relevance. Doctors did not think that the test would reliably predict future performance. However, one-third felt it was acceptable as a selection tool in conjunction with academic record. Those who found it unacceptable were influenced by its perceived narrow focus, limited job relatedness, potential for socioeconomic bias, impact on gender and potential for negative influence on student diversity. CONCLUSIONS: A selection tool that does not enjoy the confidence of the medical profession is unlikely to achieve political validity and may ultimately fail, regardless of other objective measures of its effectiveness such as predictive validity.

Translating policy into practice: a case study in the secondary prevention of coronary heart disease.

BACKGROUND: This paper focuses on the relationships between health 'policy' as it is embodied in official documentation, and health 'practice' as reported and reflected on in the talk of policy-makers, health professionals and patients. The specific context for the study involves a comparison of policies relating to the secondary prevention of coronary heart disease (CHD) in the two jurisdictions of Ireland - involving as they do a predominantly state funded (National Health Service) system in the north and a mixed health-care economy in the south. The key question is to determine how the detail of health policy as contained in policy documents connects to and gets translated into practice and action. METHODS: The data sources for the study include relevant health-care policy documents (N=5) and progress reports (N=6) in the two Irish jurisdictions, and semi-structured interviews with a range of policy-makers (N=28), practice nurses (14), general practitioners (12) and patients (13) to explore their awareness of the documents' contents and how they saw the impact of 'policy' on primary care practice. RESULTS: The findings suggest that although strategic policy documents can be useful for highlighting and channelling attention to health issues that require concerted action, they have little impact on what either professionals or lay people do. CONCLUSION: To influence the latter and to encourage a systematic approach to the delivery of health care it seems likely that contractual arrangements - specifying tasks to be undertaken and methods for monitoring and reporting on activity - are required.

Supporting the improvement and management of prescribing for urinary tract infections (SIMPle): protocol for a cluster randomized trial.

BACKGROUND: The overuse of antimicrobials is recognized as the main selective pressure driving the emergence and spread of antimicrobial resistance in human bacterial pathogens. Urinary tract infections (UTIs) are among the most common infections presented in primary care and empirical antimicrobial treatment is currently recommended. Previous research has identified that a substantial proportion of Irish general practitioners (GPs) prescribe antimicrobials for UTIs that are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland. The aim of this trial is to design, implement and evaluate the effectiveness of a complex intervention on GP antimicrobial prescribing and adult (18 years of age and over) patients' antimicrobial consumption when presenting with a suspected UTI. METHODS/DESIGN: The Supporting the Improvement and Management of Prescribing for urinary tract infections (SIMPle) study is a three-armed intervention with practice-level randomization. Adult patients presenting with suspected UTIs in primary care will be included in the study.The intervention integrates components for both GPs and patients. For GPs the intervention includes interactive workshops, audit and feedback reports and automated electronic prompts summarizing recommended first-line antimicrobial treatment and, for one intervention arm, a recommendation to consider delayed antimicrobial treatment. For patients, multimedia applications and information leaflets are included. Thirty practices will be recruited to the study; laboratory data indicate that 2,038 patients will be prescribed an antimicrobial in the study. The primary outcome is a change in prescribing of first-line antimicrobials for UTIs in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland. The study will take place over 15 months with a six-month intervention period. Data will be collected through a remote electronic anonymized data-extraction system, a text-messaging system and GP and patient interviews and surveys. The intervention will be strengthened by the implementation of a social marketing framework and an economic evaluation. TRIAL REGISTRATION: This intervention is registered at ClinicalTrials.gov, ID NCT01913860.

Effectiveness of a cognitive behavioural therapy-based rehabilitation programme (Progressive Goal Attainment Program) for patients who are work-disabled due to back pain: study protocol for a multicentre randomised controlled trial.

BACKGROUND: Psychologically informed rehabilitation programmes such as the Progressive Goal Attainment Program (PGAP) have the potential to address pain-related disability by targeting known psychological factors that inhibit rehabilitation progress. However, no randomised controlled trials of this intervention exist and it has not been evaluated in the Irish health service context. Our objective was to evaluate the clinical efficacy and cost-effectiveness of the PGAP in a multicentre randomised controlled trial with patients who are work-disabled due to back pain. METHODS AND DESIGN: Adult patients (ages 18 years and older) with nonmalignant back pain who are work-disabled because of chronic pain and not involved in litigation in relation to their pain were invited to take part. Patients were those who show at least one elevated psychosocial risk factor (above the 50th percentile) on pain disability, fear-based activity avoidance, fatigue, depression or pain catastrophizing. Following screening, patients are randomised equally to the intervention or control condition within each of the seven trial locations. Patients allocated to the control condition receive usual medical care only. Patients allocated to the PGAP intervention condition attend a maximum of 10 weekly individual sessions of structured active rehabilitation in addition to usual care. Sessions are delivered by a clinical psychologist and focus on graded activity, goal-setting, pacing activity and cognitive-behavioural therapy techniques to address possible barriers to rehabilitation.The primary analysis will be based on the amount of change on the Roland Morris Disability Questionnaire posttreatment. We will also measure changes in work status, pain intensity, catastrophizing, depression, fear avoidance and fatigue. Outcome measures are collected at baseline, posttreatment and 12-month follow-up. Health-related resource use is also collected pre- and posttreatment and at 12-month follow-up to evaluate cost-effectiveness. DISCUSSION: This study will be the first randomized controlled trial of the PGAP in chronic pain patients and will provide important information about the clinical and cost effectiveness of the programme as well as its feasibility in the context of the Irish health service. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN61650533.