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BACKGROUND: Recruiting the target number of participants within the pre-specified time frame agreed with funders remains a common challenge in the completion of a successful clinical trial and addressing this is an important methodological priority. While there is growing research around recruitment, navigating this literature to support an evidence-based approach remains difficult. The Online resource for Recruitment Research in Clinical triAls project aims to create an online searchable database of recruitment research to improve access to existing evidence and to identify gaps for future research. METHODS: MEDLINE (Ovid), Scopus, Cochrane Database of Systematic Reviews and Cochrane Methodology Register, Science Citation Index Expanded and Social Sciences Citation Index within the ISI Web of Science and Education Resources Information Center were searched in January 2015. Search strategy results were screened by title and abstract, and full text obtained for potentially eligible articles. Studies reporting or evaluating strategies, interventions or methods used to recruit patients were included along with case reports and studies exploring reasons for patient participation or non-participation. Eligible articles were categorised as systematic reviews, nested randomised controlled trials and other designs evaluating the effects of recruitment strategies (Level 1); studies that report the use of recruitment strategies without an evaluation of impact (Level 2); or articles reporting factors affecting recruitment without presenting a particular recruitment strategy (Level 3). Articles were also assigned to 1, or more, of 42 predefined recruitment domains grouped under 6 categories. RESULTS: More than 60,000 records were retrieved by the search, resulting in 56,030 unique titles and abstracts for screening, with a further 23 found through hand searches. A total of 4570 full text articles were checked; 2804 were eligible. Six percent of the included articles evaluated the effectiveness of a recruitment strategy (Level 1), with most of these assessing aspects of participant information, either its method of delivery (33%) or its content and format (28%). DISCUSSION: Recruitment to clinical trials remains a common challenge and an important area for future research. The online resource for Recruitment Research in Clinical triAls project provides a searchable, online database of research relevant to recruitment. The project has identified the need for researchers to evaluate their recruitment strategies to improve the evidence base and broaden the narrow focus of existing research to help meet the complex challenges faced by those recruiting to clinical trials.
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Bases de Datos como Asunto , Selección de Paciente , Investigación Biomédica/normas , Humanos , Tamaño de la MuestraRESUMEN
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.
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Antibacterianos/economía , Antibacterianos/uso terapéutico , Prescripción Inadecuada/prevención & control , Infecciones Urinarias/tratamiento farmacológico , Infecciones Urinarias/economía , Análisis Costo-Beneficio , Utilización de Medicamentos , Humanos , Irlanda , Uso Excesivo de Medicamentos Recetados/prevención & control , Atención Primaria de SaludRESUMEN
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.
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Antibacterianos/uso terapéutico , Medicina General/normas , Adhesión a Directriz/estadística & datos numéricos , Prescripción Inadecuada/prevención & control , Pautas de la Práctica en Medicina/normas , Infecciones Urinarias/tratamiento farmacológico , Adulto , Anciano , Farmacorresistencia Bacteriana , Femenino , Medicina General/estadística & datos numéricos , Humanos , Prescripción Inadecuada/estadística & datos numéricos , Irlanda , Masculino , Auditoría Médica , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en Medicina/estadística & datos numéricos , Sistemas RecordatoriosRESUMEN
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.
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Antiinfecciosos , Utilización de Medicamentos/estadística & datos numéricos , Prescripción Electrónica/estadística & datos numéricos , Prescripción Inadecuada/estadística & datos numéricos , Almacenamiento y Recuperación de la Información/métodos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Atención Primaria de Salud/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Factibilidad , Femenino , Humanos , Irlanda , Masculino , Persona de Mediana Edad , Vigilancia en Salud Pública , Garantía de la Calidad de Atención de Salud/métodos , Mejoramiento de la Calidad , Indicadores de Calidad de la Atención de Salud , Adulto JovenRESUMEN
Understanding the role of exposure to natural recreational waters in the acquisition and transmission of antimicrobial resistance (AMR) is an area of increasing interest. A point prevalence study was carried out in the island of Ireland to determine the prevalence of colonisation with extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-PE) and carbapenem-resistant Enterobacterales (CRE) in recreational water users (WU) and matched controls. A total of 411 adult participants (199 WU, 212 controls) submitted at least one faecal sample between September 2020 - October 2021. In total, 80 Enterobacterales were isolated from 73 participants. ESBL-PE were detected in 29 (7.1 %) participants (7 WU, 22 controls), and CRE were detected in nine (2.2 %) participants (4 WU, 5 controls). No carbapenemase-producing Enterobacterales (CPE) were detected. WU were significantly less likely to harbour ESBL-PE than controls (risk ratio = 0.34, 95 % CI 0.148 to 0.776, χ2 7.37, p = 0.007). This study demonstrates the occurrence of ESBL-PE and CRE in healthy participants in Ireland. Recreational exposure to bathing water in Ireland was associated with a decreased prevalence of colonisation with ESBL-PE and CRE.
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Antiinfecciosos , Infecciones por Enterobacteriaceae , Gammaproteobacteria , Adulto , Humanos , Infecciones por Enterobacteriaceae/epidemiología , Agua , beta-Lactamasas , Carbapenémicos , Heces , AntibacterianosRESUMEN
The increasing prevalence of extended-spectrum beta-lactamase (ESBL) producing Enterobacterales (ESBL-PE) and carbapenemase-producing Enterobacterales (CPE) is a major public health concern worldwide. Despite the associated risk of infection from gut colonisation with a resistant Enterobacterales, the incidence and duration of carriage in healthy individuals is poorly studied. This "persistence study" is the first in Ireland to assess the longitudinal carriage of ESBL-PE and CPE in healthy individuals. A cohort of 45 participants, 22 of whom were colonised with ESBL-PE, was recruited from a recently completed point prevalence study that investigated colonisation in recreational water users (WU) versus controls. Six bi-monthly faecal samples per participant were analysed for CPE and ESBL-PE over one year and the relationship between persistent colonisation and exposure to natural waters was investigated. For 11 of 45 participants (24.4 %) ESBL-E. coli (ESBL-EC) was detected in at least one sample. Genomic analysis revealed that six participants harboured the same ESBL-EC strains as identified in the preceding study. ESBL-EC persisted in the gut for a median duration of 10.3 months (range 4-23 months), consistent with previous research. Five participants (11.1 %) carried ESBL-EC for the entire study year. The carbapenemase gene blaIMI-2 was detected once. Colonisation was higher in water users during the non-bathing season (n = 10, November 2021-April 2022), than during the bathing season (n = 5, May 2022-September 2022) [relative risk 1.99 (95 % CI 0.34-11.71)]. However, overall WU were less likely to be colonised with ESBL-EC than controls (19 % vs 25 % respectively, RR 0.76, CI 0.24-2.34). Further research is warranted to better understand the factors influencing the persistence of gut colonisation with ESBL-EC and CPE and to what extent bathing water quality impacts colonisation for those regularly exposed.
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Antiinfecciosos , Escherichia coli , Humanos , Escherichia coli/genética , Enterobacteriaceae/genética , Irlanda/epidemiología , beta-Lactamasas/genética , Heces , AntibacterianosRESUMEN
Background: Hypertension is one of the most important risk factors for stroke and heart disease. Recent international guidelines have stated that 'poor adherence to treatment - in addition to physician inertia - is the most important cause of poor blood pressure control'. The MaxImising Adherence, Minimising Inertia (MIAMI) intervention, which has been developed using a systematic, theoretical, user-centred approach, aims to support general practitioners (GPs) and people with hypertension to maximise medication use, through the facilitation of adequate information exchange within consultations about long-term antihypertensive medication use and adherence skill development. The aim of the MIAMI pilot cluster randomised controlled trial (RCT) is to gather and analyse feasibility data to allow us to (1) refine the intervention, and (2) determine the feasibility of a definitive RCT. Methods: GP practices (n = 6) will be recruited and randomised to the intervention arm (n = 3) or usual care control arm (n = 3). Each practice will recruit 10 patient participants. For a patient to be eligible they must have a diagnosis of hypertension, be on two or more anti-hypertensive medications, must not be achieving recommended blood pressure levels, and be over the age of 65 years. Participants in the intervention arm will meet their GP and receive the MIAMI intervention twice over three months. Quantitative data collection will take place at baseline and three month follow up. A pilot health economic analysis and a qualitative sub-study will also be incorporated into the study. Discussion: This pilot cluster RCT of the MIAMI intervention will allow us to gather valuable acceptability and feasibility data to further refine the intervention so it optimally designed for both GP and patient use. In particular, the qualitative component will provide an insight into GP and patient experiences of using the intervention.
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Background: Uncomplicated urinary tract infections (UTIs) are among the most common presentations of bacterial infections in the outpatient setting. The variation of outcomes reported in trials to assess the most effective treatment interventions for uncomplicated UTIs has meant that comparing and synthesising the outcomes across trials is challenging and limits the reliability of evidence which would otherwise inform healthcare decisions. Objective: Develop a Core Outcome Set (COS) for interventions for the treatment of uncomplicated UTIs in otherwise healthy adults. Methods: The COS development consisted of three phases: (1) A systematic review to identify outcomes reported in randomised trials and systematic reviews of randomised trials comparing the effectiveness of any interventions for the treatment of uncomplicated UTI in otherwise healthy adults; (2) Outcomes identified in the systematic review were prioritised in an online 3-round modified Delphi survey with healthcare practitioners (n = 68), researchers (n = 5), and people who have experienced or cared for someone experiencing a UTI (n = 180); (3) An online consensus meeting to determine the final COS with healthcare practitioners and policymakers (n = 9), researchers (n = 4), and people who have experienced or cared for someone experiencing a UTI (n = 7). Results: We identified a large number of outcomes. Through the use of robust consensus methods, those outcomes were reduced to a core set of six outcomes that should, at a minimum, be measured and reported in randomised trials and systematic reviews of interventions treating uncomplicated UTIs in adults.
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Background: Uncomplicated urinary tract infections (UTIs) are amongst the most frequent infections presenting in the outpatient setting. A growing number of clinical trials are assessing the most effective treatment interventions for uncomplicated UTI. Due to the heterogeneity of the outcomes reported in these trials, however, comparing these outcomes is challenging. Objectives: Identify the core outcomes that have been reported in trials and systematic reviews of interventions treating uncomplicated UTI in adults. Methods: We conducted a systematic search for core outcomes used to evaluate treatments of UTIs. We searched the Cochrane Database of Systematic Reviews, PubMed and Embase. One researcher independently screened each article for inclusion, and the Core Outcome Set for treatment of Urinary Tract Infections (COSUTI) team acted as second reviewers. All included articles were screened by two reviewers. All outcomes were extracted verbatim, and similar outcomes were grouped into domains and subdomains. Results: In total, 334 outcomes were reported across 41 papers, the average number of outcomes reported being 8. Outcomes were categorized across 18 domains, the majority of which were related to clinical cure outcomes. Many outcomes varied in the timepoints within which the outcome was measured and reported. Conclusions: Comparing the outcomes of trials investigating uncomplicated UTI treatment remains challenging due to the difference in outcomes currently reported. Consistency of reporting of outcomes would be improved by developing a minimum number of consistent outcomes that should be reported in all trials.
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Globally, water-based bathing pastimes are important for both mental and physical health. However, exposure to waterborne organisms could present a substantial public health issue. Bathing waters are shown to contribute to the transmission of illness and disease and represent a reservoir and pathway for the dissemination of antimicrobial resistant (AMR) organisms. Current bathing water quality regulations focus on enumeration of faecal indicator organisms and are not designed for detection of specific waterborne organisms of public health concern (WOPHC), such as antimicrobial resistant (AMR)/pathogenic bacteria, or viruses. This investigation presents the first scoping review of the occurrence of waterborne organisms of public health concern (WOPHC) in identified natural bathing waters across the European Union (EU), which aimed to critically evaluate the potential risk of human exposure and to assess the appropriateness of the current EU bathing water regulations for the protection of public health. Accordingly, this review sought to identify and synthesise all literature pertaining to a selection of bacterial (Campylobacter spp., Escherichia coli, Salmonella spp., Shigella spp., Vibrio spp., Pseudomonas spp., AMR bacteria), viral (Hepatitis spp., enteroviruses, rotavirus, adenovirus, norovirus), and protozoan (Giardia spp., and Cryptosporidium spp.) contaminants in EU bathing waters. Sixty investigations were identified as eligible for inclusion and data was extracted. Peer-reviewed investigations included were from 18 countries across the EU, totalling 87 investigations across a period of 35 years, with 30% published between 2011 and 2015. A variety of water bodies were identified, with 27 investigations exclusively assessing coastal waters. Waterborne organisms were classified into three categories; bacteria, viruses, and protozoa; amounting to 58%, 36% and 17% of the total investigations, respectively. The total number of samples across all investigations was 8,118, with detection of one or more organisms in 2,449 (30%) of these. Viruses were detected in 1281 (52%) of all samples where WOPHC were found, followed by bacteria (865(35%)) and protozoa (303(12%)). Where assessed (442 samples), AMR bacteria had a 47% detection rate, emphasising their widespread occurrence in bathing waters. Results of this scoping review highlight the potential public health risk of exposure to WOPHC in bathing waters that normally remain undetected within the current monitoring parameters.
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Criptosporidiosis , Cryptosporidium , Humanos , Salud Pública , Microbiología del Agua , Calidad del AguaRESUMEN
BACKGROUND: Breastfeeding is a complex behaviour relying on a combination of individual mother and infant characteristics, health systems, and family, community and professional support. Optimal breastfeeding in high-income countries is particularly low. Despite having similar sociocultural backgrounds, breastfeeding rates between Ireland, the United Kingdom (UK) and Australia vary, thus there is a need to understand whether this is due to individual, sociocultural or policy differences. This research identifies the between-country differences in infant feeding mode and examines if country differences in feeding mode persist once known individual, behavioural and structural factors are considered using socioecological and person-context models. METHODS: Participants were adult women with at least one infant less than 6 months of age, who completed an online survey (n = 2047) that was distributed by social media in June 2016. Within-country differences in infant feeding mode ('any breastfeeding' vs. 'no breastfeeding') were examined first before hierarchical multivariable logistic regression was used to determine if country differences in feeding mode persisted after adjusting for known factors associated with breastfeeding. RESULTS: In this sample, 'any breastfeeding' rates were 89, 71 and 72% in Australia, Ireland and the United Kingdom respectively. Within-country differences were evident in Australia, Ireland and the UK. Four factors showed no association with infant feeding mode in Australia while they did in the other countries (maternal age, income, skin-to-skin contact, support from friends and family). Two factors were unique to Australia: the odds of being in the 'no breastfeeding' group increased when the baby was delivered via caesarean and when not enough breastfeeding information was available after birth. One determinant was unique to Ireland: the odds of being in the 'no breastfeeding' group increased when respondents indicated they were not religious; in the UK this occurred when respondents were living in a town/village. After adjusting for sets of known factors of infant feeding mode based on socioecological and person-context models, country differences remained in hierarchical regressions: the odds of not breastfeeding were higher in both Ireland (AOR 3.3, 95%CI 1.8,6.1) and the United Kingdom (AOR 2.7, 95%CI 1.5, 4.7) compared to Australia. CONCLUSIONS: This study indicates that different levels in the socioecological system are related to infant feeding behaviours. An adequate inter-systems level response would consider the interactions within and between behavioural and structural mechanisms which support breastfeeding behaviour. Optimising infant feeding practices will require an integrated web of interventions that go beyond the individual and focus on addressing factors that will influence families within their communities as they move between systems.
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Lactancia Materna , Adulto , Australia , Estudios Transversales , Femenino , Humanos , Lactante , Irlanda , Embarazo , Reino UnidoRESUMEN
Background: Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. One area in need of research is trial recruitment. Recruiting patients to trials is a major challenge facing trialists. Failure to meet recruitment targets can result in delays and underpowered studies. This SWAT evaluates the effectiveness of hand-held digital multimedia presentation of trial information and standard written patient information to potential participants on recruitment and retention to a host trial. Methods: This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT) (ISRCTN12838042) designed within a host trial - the SATIN trial (ISRCTN88111427), a RCT designed for implementation in the Irish primary care setting. The SWAT eligibility criteria was determined by the host trial. General practices who agree to participate in the host trial will provide women (participants) who are willing to consider participating in the host trial with either a multimedia digital information resource facilitated through a handheld tablet device, plus a written participant information leaflet (Intervention) or a written participant information leaflet (comparator). Outcomes are recruitment and retention to the host SATIN trial and participant's quality of decision-making. Discussion: Although designed to be implemented in a host trial, the host trial, was suspended and therefore this SWAT was not implemented. The protocol and the lessons learnt whilst developing it offer guidance to researchers who wish to answer similar research questions in the future in a similar context or setting. Trial registration: ISRCTN Registry ISRCTN12838042 (11/10/2017).
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BACKGROUND: In general practice, males represent around 20% of the total number of urinary tract infection (UTI) consultations. The majority of UTI research focuses on the diagnosis and treatment of women with UTIs but there is little evidence on how male UTIs are treated. AIM: To better understand GPs' attitudes towards the diagnosis and treatment of male UTIs. This research aimed to support future investigations to determine best practice in diagnosis and treatment of male UTI. DESIGN AND SETTING: A qualitative interview study was carried out with 15 GPs across Ireland. METHOD: A topic guide was created to ensure consistency in interviews. The interviews were audiorecorded and transcribed verbatim. Transcripts were analysed using thematic analysis. RESULTS: Fifteen interviews with GPs were completed. Analysis indicated that GPs' knowledge of guidelines and implementation of them varied widely when deciding a treatment plan for a male presenting with UTI symptoms. There was clear consensus that male UTIs were uncommon and complicated to diagnose. Three GPs reported never treating a male UTI, while others reported treating <5 patients in their careers. There was an assumption that sexually transmitted infections (STI) take precedence in young males when presenting with similar symptoms. The use of antimicrobial treatment guidelines varied widely, in line with the interpretation of the origin and severity of symptoms. CONCLUSION: Male UTIs are perceived by GPs as rare and complicated. GPs expressed that patient age, resources, and guidelines available limited their confidence in diagnosing and treating male UTIs.
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BACKGROUND: Urinary tract infections (UTIs) are the second most common infection presenting in the community. Clinical guidelines and decision aids assist health practitioners to treat a UTI; however, treatment practices vary due to patient needs and context of presentation. Numerous trials have evaluated the effectiveness of treatment interventions for UTI; however, it is difficult to compare the results between trials due to inconsistencies between reported outcomes. Poor choice of outcome measures can lead to impairment of evidence synthesis due to the inability to compare outcomes between trials with similar aims. Transparency in selecting and reporting outcomes can be mitigated through the development of an agreed minimum set of outcomes that should be reported in clinical trials, referred to as a core outcome set (COS). This paper presents the protocol for the development of a COS for interventions in the treatment of uncomplicated UTI in adults. METHODS: This COS development consists of three phases. Phase 1 is a systematic review, which aims to identify the core outcomes that have been reported in trials and systematic reviews of interventions treating uncomplicated UTI in adults. Phase 2 consists of a three-round online Delphi survey with stakeholders in the area of treatment interventions for UTI. The aim of this online Delphi survey is to achieve consensus on the importance of the outcomes emerging from Phase 1 of this research. Phase 3 is a consensus meeting to finalise the COS that should be reported in trials evaluating the effectiveness of interventions for the treatment of UTI. DISCUSSION: It is hoped that the development of a COS for interventions for the treatment of uncomplicated UTI in adults will be adopted as a minimum set of outcomes that should be reported and measured within this context. If the findings from clinical trials related to treatment interventions for UTI are to impact on policy and practice, it is important that the findings from different treatment interventions are comparable across trials.
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Antibacterianos/uso terapéutico , Ensayos Clínicos como Asunto/métodos , Determinación de Punto Final , Proyectos de Investigación , Infecciones Urinarias/tratamiento farmacológico , Antibacterianos/efectos adversos , Consenso , Conferencias de Consenso como Asunto , Técnica Delphi , Humanos , Participación de los Interesados , Revisiones Sistemáticas como Asunto , Resultado del Tratamiento , Infecciones Urinarias/diagnóstico , Infecciones Urinarias/microbiologíaRESUMEN
BACKGROUND: Mobile phones offer new opportunities to efficiently and interactively collect real-time data from patients with acute illnesses, such as urinary tract infections (UTIs). One of the main benefits of using mobile data collection methods is automated data upload, which can reduce the chance of data loss, an issue when using other data collection methods such as paper-based surveys. OBJECTIVE: The aim was to explore differences in collecting data from patients with UTI using text messaging, a mobile phone app (UTI diary), and an online survey. This paper provides lessons learned from integrating mobile data collection into a randomized controlled trial. METHODS: Participants included UTI patients consulting in general practices that were participating in the Supporting the Improvement and Management of UTI (SIMPle) study. SIMPle was designed to improve prescribing antimicrobial therapies for UTI in the community. Patients were invited to reply to questions regarding their UTI either via a prospective text message survey, a mobile phone app (UTI diary), or a retrospective online survey. Data were collected from 329 patients who opted in to the text message survey, 71 UTI patients through the mobile phone UTI symptom diary app, and 91 online survey participants. RESULTS: The age profile of UTI diary app users was younger than that of the text message and online survey users. The largest dropout for both the text message survey respondents and UTI diary app users was after the initial opt-in message; once the participants completed question 1 of the text message survey or day 2 in the UTI diary app, they were more likely to respond to the remaining questions/days. CONCLUSIONS: This feasibility study highlights the potential of using mobile data collection methods to capture patient data. As well as improving the efficiency of data collection, these novel approaches highlight the advantage of collecting data in real time across multiple time points. There was little variation in the number of patients responding between text message survey, UTI diary, and online survey, but more patients participated in the text message survey than the UTI diary app. The choice between designing a text message survey or UTI diary app will depend on the age profile of patients and the type of information the researchers' desire. TRIAL REGISTRATION: ClinicalTrials.gov NCT01913860; https://clinicaltrials.gov/ct2/show/NCT01913860 (Archived by WebCite at http://www.webcitation.org/6pfgCztgT).
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"Delayed or back up" antibiotic prescriptions and "symptomatic" treatment may help to reduce inappropriate antibiotic prescribing for Urinary Tract Infections (UTI) in the future. However, more research needs to be conducted in this area before these strategies can be readily promoted in practice. This study explores General Practitioner (GP) and patient attitudes and experiences regarding the use of delayed or back-up antibiotic and symptomatic treatment for UTI. Qualitative face to face interviews with General Practitioners (n = 7) from one urban and one rural practice and telephone interviews with UTI patients (n = 14) from a rural practice were undertaken. Interviews were analysed using framework analysis. GPs believe that antibiotics are necessary when treating UTI. There was little consensus amongst GPs regarding the role of delayed prescribing or symptomatic treatment for UTI. Delayed prescribing may be considered for patients with low grade symptoms and a negative dipstick test. Patients had limited experience of delayed prescribing for UTI. Half indicated they would be satisfied with a delayed prescription the other half would question it. A fear of missing a serious illness was a significant barrier to symptomatic treatment for both GP and patient. The findings of this research provide insight into antibiotic prescribing practices in general practice. It also highlights the need for further empirical research into the effectiveness of alternative treatment strategies such as symptomatic treatment of UTI before such strategies can be readily adopted in practice.
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Current antimicrobial prescribing guidelines indicate that male and female patients with urinary tract infections (UTIs) should be treated with same antimicrobials but for different durations. The aim of this study was to explore the differences in reconsultations and antimicrobial prescribing for UTI for both males and females. A total of 2557 adult suspected UTI patients participating in the Supporting the Improvement and Management of Prescribing for urinary tract infection (SIMPle) study from 30 general practices were analyzed. An antimicrobial was prescribed significantly more often to females (77%) than males (63%). Nitrofurantoin was prescribed more often for females and less often for males (58% vs. 41%), while fluoroquinolones were more often prescribed for males (11% vs. 3%). Overall, reconsultation was 1.4 times higher in females, and if the antimicrobial prescribed was not the recommended first-line (nitrofurantoin), reconsultation after empirical prescribing was significantly higher. However, the reconsultation was similar for males and females if the antimicrobial prescribed was first-line. When a urine culture was obtained, a positive culture was the most important predictor of reconsultation (Odds ratio 1.8 (95% CI 1.3-2.5)). This suggests, when prescribing empirically, that male and female UTI patients should initially be treated with first-line antimicrobials (nitrofurantoin) with different durations (50-100 mg four times daily for three days in females and seven days for males). However, the consideration of a culture test before prescribing antimicrobials may improve outcomes.
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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.
Asunto(s)
Antibacterianos/uso terapéutico , Actitud del Personal de Salud , Pautas de la Práctica en Medicina/estadística & datos numéricos , Investigación Cualitativa , Infecciones Urinarias/tratamiento farmacológico , Adulto , Femenino , Grupos Focales , Medicina General/estadística & datos numéricos , Médicos Generales/estadística & datos numéricos , Humanos , Entrevistas como Asunto , Irlanda , Masculino , Persona de Mediana EdadRESUMEN
Inappropriate antimicrobial prescribing contributes to the global spread of antimicrobial resistance. The pending weekend with changed availability of general practitioners (GP) and increased patient concern may increase the intention to prescribe antimicrobials. The aim of this study is to analyse variation in antimicrobial prescribing between weekdays and weekend in Irish general practice. All prescribing data over a 15 month period was obtained from the 30 practices participating in the Supporting the Improvement and Management of Prescribing for urinary tract infection (SIMPle) study. Antimicrobials were classified using anatomical therapeutic chemical classification code guidelines. Prescribing of antimicrobials per total number of prescriptions was compared between weekdays (Monday to Thursday) and the weekend (Friday to Sunday). Antimicrobials were generally more often prescribed during weekends; the antimicrobial prescribing rate was greater by 9.2 % on Friday compared to average prescribing on other weekdays (21.4 vs. 19.6 %). The chance of an antimicrobial prescription was 1.07 (95 % CI 1.04-1.10) higher on weekend days compared to weekdays. This was reflected in increased prescriptions for ampicillin, co-amoxiclav, nitrofurantoin, quinolones and macrolides. However, if antimicrobials were prescribed, no significant differences were observed between weekdays and weekend among the different classes of antimicrobials. GPs prescribe relatively more antimicrobials during the weekend compared to weekdays. However, the patterns of antimicrobial prescribing did not differ according to the day of prescription. Trial Registration The intervention was registered with ClinicalTrials.gov on 26 July 2013, ID number NCT01913860.
RESUMEN
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.