Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme.

Background: Randomised controlled trials ('trials') are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and retention. However, relatively few of these have been conducted. Objectives: PROMoting THE Use of Studies Within A Trial aimed to facilitate at least 25 Studies Within A Trial evaluating recruitment or retention strategies. We share our experience of delivering the PROMoting THE Use of Studies Within A Trial programme, and the lessons learnt for undertaking randomised Studies Within A Trial. Design: A network of 10 Clinical Trials Units and 1 primary care research centre committed to conducting randomised controlled Studies Within A Trial of recruitment and/or retention strategies was established. Promising recruitment and retention strategies were identified from various sources including Cochrane systematic reviews, the Study Within A Trial Repository, and existing prioritisation exercises, which were reviewed by patient and public members to create an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding and receive support from the PROMoting THE Use of Studies Within A Trial team to undertake Studies Within A Trial. We also tested the feasibility of undertaking co-ordinated Studies Within A Trial, across multiple host trials simultaneously. Setting: Clinical trials unit-based trials recruiting or following up participants in any setting in the United Kingdom were eligible. Participants: Clinical trials unit-based teams undertaking trials in any clinical context in the United Kingdom. Interventions: Funding of up to £5000 and support from the PROMoting THE Use of Studies Within A Trial team to design, implement and report Studies Within A Trial. Main outcome measures: Number of host trials funded. Results: Forty-two Studies Within A Trial were funded (31 host trials), across 12 Clinical Trials Units. The mean cost of a Study Within A Trial was £3535. Twelve Studies Within A Trial tested the same strategy across multiple host trials using a co-ordinated Study Within A Trial design, and four used a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. PROMoting THE Use of Studies Within A Trial will add 18% more Studies Within A Trial to the Cochrane systematic review of recruitment strategies, and 79% more Studies Within A Trial to the Cochrane review of retention strategies. For retention, we found that pre-notifying participants by card, letter or e-mail before sending questionnaires was effective, as was the use of pens, and sending personalised text messages to improve questionnaire response. We highlight key lessons learnt to guide others planning Studies Within A Trial, including involving patient and public involvement partners; prioritising and selecting strategies to evaluate and elements to consider when designing a Study Within A Trial; obtaining governance approvals; implementing Studies Within A Trial, including individual and co-ordinated Studies Within A Trials; and reporting Study Within A Trials. Limitations: The COVID-19 pandemic negatively impacted five Studies Within A Trial, being either delayed (n = 2) or prematurely terminated (n = 3). Conclusions: PROMoting THE Use of Studies Within A Trial significantly increased the evidence base for recruitment and retention strategies. When provided with both funding and practical support, host trial teams successfully implemented Studies Within A Trial. Future work: Future research should identify and target gaps in the evidence base, including widening Study Within A Trial uptake, undertaking more complex Studies Within A Trial and translating Study Within A Trial evidence into practice. Study registration: All Studies Within A Trial in the PROMoting THE Use of Studies Within A Trial programme had to be registered with the Northern Ireland Network for Trials Methodology Research Study Within A Trial Repository. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/55/80) and is published in full in Health Technology Assessment; Vol. 28, No. 2. See the NIHR Funding and Awards website for further award information.

A Study Within A Trial is a research study nested inside a larger 'host trial', promoting the use of Studies Within A Trial aimed to do Study Within A Trial routine practice in clinical trial units by funding and supporting at least 25 Studies Within A Trial. The best way to test health and social care treatments is to do a randomised controlled trial ('trial'), where some patients get the treatment being tested and some do not. The results of different groups are compared to see if the treatment improves care. Recruiting patients and keeping them involved in trials is often very difficult. Research teams often do not know how best to recruit and keep patients engaged as the methods have not been tested to see if they work. The best way to test these methods is by doing a Study Within A Trial. We test a programme of Studies Within A Trial for recruiting and keeping patients engaged in trials. Trial teams were able to apply for funding of up to £5000 and receive support from Promoting the use of Study Within A Trial team to do Studies Within A Trial. We used our experience of doing Studies Within A Trial to outline lessons learnt for doing Studies Within A Trial. We funded 42 Studies Within A Trial and gave teams necessary advice to do them. We significantly increased the knowledge for both recruitment and retention strategies, and found 'pre-notifying' before sending questionnaires, sending pens and personalised text messages were all effective for increasing responses by participants. We tested Studies Within A Trial across several different trials at the same time to find out more quickly whether their methods worked. We highlight key lessons learnt to guide others doing Studies Within A Trial, including involving patient partners; picking the right strategy to test; getting ethical approvals; how to do and report Studies Within A Trial. Promoting the use of studies within a trial was successful and supported more Studies Within A Trial than planned. We hope our experience will support those doing Studies Within A Trial in the future.

Irish funder guidance increased searching for, and uptake of, core outcome sets.

OBJECTIVES: Assess the impact of the Health Research Board (HRB) Ireland guidance on the uptake of core outcome sets (COSs). STUDY DESIGN AND SETTING: (1) Information on COS use, searching of the Core Outcome Measures in Effectiveness Trials (COMET) database, and rationale for outcome selection were extracted from HRB funding applications (2) COMET was searched for relevant COS availability at the time of application or developed since (3) principal investigator choices were explored through online surveys. RESULTS: Out of 187 funding applications, 44% (n = 82) searched the COMET database, and 13% (n = 11) of those found a relevant COS to inform their outcomes. Four applicants proposed COS development. However, 84% (n = 156) of applications had no relevant COS available at the time of submission, as identified by subsequent author COMET search. Among 84 principal investigators who participated in the surveys, 10 (12%) found and used a COS and 19 (42%) of the 45 respondents who did not have reference to COMET had searched the COMET database. A new question in the application form prompted a rise in those reporting a search of the COMET database from 6% to 99%. CONCLUSION: The study found low COS uptake in funding applications, but a new application question prompted an increase in reporting searches of the COMET database. Funder guidance promoted COS awareness and use, but more efforts are needed to facilitate COS development and adoption in clinical research.

The People's Trial: supporting the public's understanding of randomised trials.

BACKGROUND: Randomised trials are considered the gold standard in providing robust evidence on the effectiveness of interventions. However, there are relatively few initiatives to help increase public understanding of what randomised trials are and why they are important. This limits the overall acceptance of and public participation in clinical trials. The People's Trial aims to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims by actively involving them in all aspects of trial design. This was done by involving the public in the design, conduct, and dissemination of a randomised trial. METHODS: Using a reflexive approach, we describe the processes of development, conduct, and dissemination of The People's Trial. RESULTS: Over 3000 members of the public, from 72 countries, participated in The People's Trial. Through a series of online surveys, the public designed a trial called The Reading Trial. They chose the question the trial would try to answer and decided the components of the trial question. In December 2019, 991 participants were recruited to a trial to answer the question identified and prioritised by the public, i.e. 'Does reading a book in bed make a difference to sleep in comparison with not reading a book in bed?' We report the processes of The People's Trial in seven phases, paralleling the steps of a randomised trial, i.e. question identification and prioritisation, recruitment, randomisation, trial conduct, data analysis, and sharing of findings. We describe the decisions we made, the processes we used, the challenges we encountered, and the lessons we learned. CONCLUSION: The People's Trial involved the public successfully in the design, conduct, and dissemination of a randomised trial demonstrating the potential for such initiatives to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims. TRIAL REGISTRATION: ClinicalTrials.gov NCT04185818 . Registered on 4 December 2019.

Does reading a book in bed make a difference to sleep in comparison to not reading a book in bed? The People's Trial-an online, pragmatic, randomised trial.

BACKGROUND: The best way of comparing healthcare treatments is through a randomised trial. In a randomised trial, we compare something (a treatment or intervention) to something else, often another treatment. Who gets what is decided at random, meaning everyone has an equal chance of getting any of the treatments. This means any differences found can be put down to the treatment received rather than other things, such as where people live, or health conditions they might have. The People's Trial aimed to help the public better understand randomised trials by inviting them to design and carry out a trial. The question chosen by the public for The People's Trial was: 'Does reading a book in bed make a difference to sleep, in comparison to not reading a book in bed?' This paper describes that trial, called 'The Reading Trial'. METHODS: The Reading Trial was an online, randomised trial. Members of the public were invited to take part through social media campaigns. People were asked to either read a book in bed before going to sleep (intervention group) or not read a book in bed before going to sleep (control group). We asked everyone to do this for 7 days, after which they measured their sleep quality. RESULTS: During December 2019, a total of 991 people took part in The Reading Trial, half (496 (50%)) in the intervention group and half (495 (50%)) in the control group. Not everyone finished the trial: 127 (25.6%) people in the intervention group and 90 (18.18%) people in the control group. Of those providing data, 156/369 (42%) people in the intervention group felt their sleep improved, compared to 112/405 (28%) of those in the control group, a difference of 14%. When we consider how certain we are of this finding, we estimate that, in The Reading Trial, sleep improved for between 8 and 22% more people in the intervention group compared to the control group. CONCLUSIONS: Reading a book in bed before going to sleep improved sleep quality, compared to not reading a book in bed. TRIAL REGISTRATION: ClinicalTrials.gov NCT04185818. Registered on 4 December 2019.

Can learning about trials be child's play? A qualitative exploration of the 'Schools Teaching Awareness of Randomised Trials' (START) initiative.

BACKGROUND: The Health Research Board-Trials Methodology Research Network (HRB-TMRN) celebrates International Clinical Trials Day with the help of the younger members of our community through the Network's 'Schools Teaching Awareness of Randomised Trials (START)' initiative. START seeks to increase public awareness of randomised trials in Ireland. Launched in 2016, it asks children (8-12 years old) to conduct and report their very own fun randomised trial. The study reported in this paper sought to explore children and teachers perceptions and experiences of the START initiative. METHODS: We conducted eight, one-to one interviews with teachers and eight focus groups with 61 children who took part in the 2018 START initiative. Interviews and focus groups were recorded and transcribed and the data analysed using template analysis. RESULTS: The findings of this study highlight the benefits of participating in START and the areas of the initiative that required further attention. Teachers and children recalled the benefits of experiential learning associated with START and learning by doing encouraged a fun way of engaging with trial processes. By recalling all aspects of planning, conducting and reporting their trial, the children in this study demonstrated their awareness of the trial processes. The teachers suggested that START provides a valuable framework to contribute to key aspects of the primary school curriculum in Ireland. The experiences of these participants also provided recommendation for improving the programme for future START participants. CONCLUSIONS: Increasing public awareness and understanding of randomised trials can help increase public engagement in trials. By educating children about the importance of trials and supporting them to 'learn by doing' by carrying out their own trial, the START initiative can contribute substantially to children's awareness and understanding of trial processes. Given that children are the public, the patients and the researchers of the future, initiatives such as START deserve attention.

Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed.

The evidence base available to trialists to support trial process decisions-e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants-is thin. One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. These are self-contained research studies embedded within a host trial that aim to evaluate or explore alternative ways of delivering or organising a particular trial process.SWATs are increasingly being supported by funders and considered by trialists, especially in the UK and Ireland. At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial? A framework for answering such a question is needed to avoid SWATs themselves contributing to research waste.This paper presents criteria on when enough evidence is available for SWATs that use randomised allocation to compare different interventions.

Battling the COVID-19 infodemic in an Irish context: the role of iHealthFacts.

On the 11 th of March 2020, the World Health Organisation (WHO) declared a global pandemic due to the SARS-CoV-2 virus, which causes coronavirus disease 2019 (COVID-19). This was one month after Dr. Tedros Adhanom Ghebreyesus, Director-General of the WHO declared that we are also fighting an 'infodemic'. The WHO has described an infodemic as an "over-abundance of information - some accurate and some not - that makes it hard for people to find trustworthy sources and reliable guidance when they need it". iHealthFacts.ie is an Irish resource where the public can quickly and easily check the credibility and reliability of health claims circulating on social media. Unreliable claims can lead to poorly informed health choices. iHealthFacts is an initiative that supports the public to think critically about health claims and make well-informed choices. Here, we describe the role iHealthFacts plays in providing reliable information to the public and offer reflections from those involved in launching this initiative during a pandemic.

What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study.

BACKGROUND: One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is little evidence supporting methods to improve retention. This paper reports the PRioRiTy II project, a Priority Setting Partnership (PSP) that identified and prioritised unanswered questions and uncertainties around trial retention in collaboration with key stakeholders. METHODS: This PSP was conducted in collaboration with the James Lind Alliance, a non-profit making initiative, to support key stakeholders (researchers, patients, and the public) in jointly identifying and agreeing on priority research questions. There were three stages. (1) First an initial online survey was conducted consisting of six open-ended questions about retention in randomised trials. Responses were coded into thematic groups to create a longlist of questions. The longlist of questions was checked against existing evidence to ensure that they had not been answered by existing research. (2) An interim stage involved a further online survey where stakeholders were asked to select questions of key importance from the longlist. (3) A face-to-face consensus meeting was held, where key stakeholder representatives agreed on an ordered list of 21 unanswered research questions for methods of improving retention in randomised trials. RESULTS: A total of 456 respondents yielded 2431 answers to six open-ended questions, from which 372 questions specifically about retention were identified. Further analysis included thematically grouping all data items within answers and merging questions in consultation with the Steering Group. This produced 27 questions for further rating during the interim survey. The top 21 questions from the interim online survey were brought to a face-to-face consensus meeting in which key stakeholder representatives prioritised the order. The 'Top 10' of these are reported in this paper. The number one ranked question was 'What motivates a participant's decision to complete a clinical trial?' The entire list will be available at www.priorityresearch.ie . CONCLUSION: The Top 10 list can inform the direction of future research on trial methods and be used by funders to guide projects aiming to address and improve retention in randomised trials.

Bedside Nurse Acceptance of Intensive Care Unit Telemedicine Presence.

Since 2010, health care organizations have rapidly adopted telemedicine as part of their health care delivery system to inpatients and outpatients. The application of telemedicine in the intensive care unit is often referred to as tele-ICU In telemedicine, nurses, nurse practitioners, physicians, and other health care professionals provide patient monitoring and intervention from a remote location. Tele-ICU presence has demonstrated positive outcomes such as increased adherence to evidence-based care and improved perception of support at the bedside. Despite the successes, acceptance of tele-ICU varies. Known barriers to acceptance include perceptions of intrusiveness and invasion of privacy.

Improving trial recruitment processes: how qualitative methodologies can be used to address the top 10 research priorities identified within the PRioRiTy study.

How can we improve recruitment to trials? In their recently published paper, Healy et al. outline the top 10 prioritised questions for trial recruitment research identified by the PRioRiTy study. The challenge now is for researchers to answer these questions; but how best can these be answered? In this commentary, we illustrate how qualitative research can be utilised to generate in-depth insight into trial recruitment issues, either as a stand-alone methodology, or through a mixed-methods approach. Consideration is given to how different forms of qualitative research can be used to address these priorities and to help researchers set out an agenda to optimise its value.

Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study.

BACKGROUND: Despite the problem of inadequate recruitment to randomised trials, there is little evidence to guide researchers on decisions about how people are effectively recruited to take part in trials. The PRioRiTy study aimed to identify and prioritise important unanswered trial recruitment questions for research. The PRioRiTy study - Priority Setting Partnership (PSP) included members of the public approached to take part in a randomised trial or who have represented participants on randomised trial steering committees, health professionals and research staff with experience of recruiting to randomised trials, people who have designed, conducted, analysed or reported on randomised trials and people with experience of randomised trials methodology. METHODS: This partnership was aided by the James Lind Alliance and involved eight stages: (i) identifying a unique, relevant prioritisation area within trial methodology; (ii) establishing a steering group (iii) identifying and engaging with partners and stakeholders; (iv) formulating an initial list of uncertainties; (v) collating the uncertainties into research questions; (vi) confirming that the questions for research are a current recruitment challenge; (vii) shortlisting questions and (viii) final prioritisation through a face-to-face workshop. RESULTS: A total of 790 survey respondents yielded 1693 open-text answers to 6 questions, from which 1880 potential questions for research were identified. After merging duplicates, the number of questions was reduced to 496. Questions were combined further, and those that were submitted by fewer than 15 people and/or fewer than 6 of the 7 stakeholder groups were excluded from the next round of prioritisation resulting in 31 unique questions for research. All 31 questions were confirmed as being unanswered after checking relevant, up-to-date research evidence. The 10 highest priority questions were ranked at a face-to-face workshop. The number 1 ranked question was "How can randomised trials become part of routine care and best utilise current clinical care pathways?" The top 10 research questions can be viewed at www.priorityresearch.ie . CONCLUSION: The prioritised questions call for a collective focus on normalising trials as part of clinical care, enhancing communication, addressing barriers, enablers and motivators around participation and exploring greater public involvement in the research process.

Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiative that aims to increase the evidence base for trial decision-making and in doing so, to improve trial efficiency.One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This guidance document provides a brief definition of SWATs, an explanation of why they are important and some practical 'top tips' that come from existing experience of doing SWATs. We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one.

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.

Using qualitative insights to change practice: exploring the culture of antibiotic prescribing and consumption for urinary tract infections.

OBJECTIVES: The aim of this paper is to explore the culture of antibiotic prescribing and consumption in the community for urinary tract infections (UTI) from the perspective of the general practitioners (GPs) and community member. DESIGN: Indepth interviews were conducted with GPs, and focus groups were held with community members. SETTING: General practice and community setting. PARTICIPANTS: 15 GPs practising in rural and urban locations in Ireland participated in the indepth interviews. 6 focus groups (n=42) with participants who had direct or indirect experiences with UTI were also undertaken. RESULTS: The decision to prescribe or consume an antibiotic for a UTI is a set of complex processes including need recognition, information search and evaluation processes governed by the relationship and interactions between the GP and the patient. Different GP and patient decision-making profiles emerged emphasising the diversity and variety of general practice in real-life settings. The GP findings showed a requirement for more microbiological information on antibiotic resistance patterns to inform prescribing decisions. Focus group participants wanted a conversation with the GP about their illness and the treatment options available. CONCLUSIONS: Collectively, this research identified the consultation as a priority intervention environment for stimulating change in relation to antibiotics. This paper demonstrates how qualitative research can identify the interacting processes which are instrumental to the decision to prescribe or consume an antibiotic for a suspected UTI. Qualitative research empowers researchers to investigate the what, how and why of interventions in real-life setting. Qualitative research can play a critical and instrumental role in designing behavioural change strategies with high impact on practice. The results of this research were used to design a complex intervention informed by social marketing. TRIAL REGISTRATION NUMBER: NCT01913860; Pre-results.

Intervention to improve the quality of antimicrobial prescribing for urinary tract infection: a cluster randomized trial.

BACKGROUND: Overuse of antimicrobial therapy in the community adds to the global spread of antimicrobial resistance, which is jeopardizing the treatment of common infections. METHODS: We designed a cluster randomized complex intervention to improve antimicrobial prescribing for urinary tract infection in Irish general practice. During a 3-month baseline period, all practices received a workshop to promote consultation coding for urinary tract infections. Practices in intervention arms A and B received a second workshop with information on antimicrobial prescribing guidelines and a practice audit report (baseline data). Practices in intervention arm B received additional evidence on delayed prescribing of antimicrobials for suspected urinary tract infection. A reminder integrated into the patient management software suggested first-line treatment and, for practices in arm B, delayed prescribing. Over the 6-month intervention, practices in arms A and B received monthly audit reports of antimicrobial prescribing. RESULTS: The proportion of antimicrobial prescribing according to guidelines for urinary tract infection increased in arms A and B relative to control (adjusted overall odds ratio [OR] 2.3, 95% confidence interval [CI] 1.7 to 3.2; arm A adjusted OR 2.7, 95% CI 1.8 to 4.1; arm B adjusted OR 2.0, 95% CI 1.3 to 3.0). An unintended increase in antimicrobial prescribing was observed in the intervention arms relative to control (arm A adjusted OR 2.2, 95% CI 1.2 to 4.0; arm B adjusted OR 1.4, 95% CI 0.9 to 2.1). Improvements in guideline-based prescribing were sustained at 5 months after the intervention. INTERPRETATION: A complex intervention, including audit reports and reminders, improved the quality of prescribing for urinary tract infection in Irish general practice. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01913860.

Improving antimicrobial prescribing in Irish primary care through electronic data collection and surveillance: a feasibility study.

BACKGROUND: The increase in the spread of antimicrobial resistance (AMR) in bacterial pathogens and limited availability of new antimicrobials places immense pressure on general practitioners (GPs) to prescribe appropriately. Currently, electronic antimicrobial prescribing data is not routinely collected from GPs in Ireland for surveillance purposes to assess regional specific fluctuations or trends in antimicrobial prescribing. The current study aimed to address this issue by assessing the feasibility of remotely extracting antimicrobial prescribing data from primary care practices in Ireland, for the purpose of assessing prescribing quality using the European Surveillance of Antimicrobial Consumption (ESAC) drug specific quality indicators. METHODS: Participating practices (n = 30) uploaded data to the Irish Primary Care Research Network (IPCRN). The IPCRN data extraction facility is integrated within the practice patient management software system and permitted the extraction of anonymised patient prescriptions for a one year period, from October 2012 to October 2013. The quality of antimicrobial prescribing was evaluated using the twelve ESAC drug specific quality indicators using the defined daily dose (DDD) per 1,000 inhabitants per day (DID) methodology. National and European prescribing surveillance data (based on total pharmacy sales) was obtained for a comparative analysis. RESULTS: Antimicrobial prescriptions (n = 57,079) for 27,043 patients were obtained from the thirty study practices for a one year period. On average, study practices prescribed a greater proportion of quinolones (37 % increase), in summer compared with winter months, a variation which was not observed in national and European data. In comparison with national data, study practices prescribed higher proportions of ß-lactamase-sensitive penicillins (4.98 % vs. 4.3 %) and a greater use of broad spectrum compared to narrow-spectrum antimicrobials (ratio = 9.98 vs. 6.26) was observed. Study practices exceeded the European mean for prescribing combinations of penicillins, including ß-lactamase inhibitors. CONCLUSIONS: This research demonstrates the feasibility and potential use of direct data extraction of anonymised practice data directly through the patient management software system. The data extraction methods described can facilitate the provision of routinely collected data for sustained and inclusive surveillance of antimicrobial prescribing. These comparisons may initiate further improvements in antimicrobial prescribing practices by identifying potential areas for improvement.

What is the best method? Recovery of methicillin-resistant Staphylococcus aureus and extended-spectrum ß-lactamase-producing Escherichia coli from inanimate hospital surfaces.

Environmental sampling in hospitals, when required, needs to be reliable. We evaluated different methods of sampling methicillin-resistant Staphylococcus aureus and extended-spectrum ß-lactamase-producing Escherichia coli on 5 materials of the hospital setting. Petrifilms and contact plates were superior to swabs for all of the surfaces studied.

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.