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Background Accurately measuring BMI in large epidemiological studies is problematic as objective measurements are expensive, so subjective methodologies must usually suffice. The purpose of this study is to explore a new subjective method of BMI measurement: BMI self-selection. Methods A cross-sectional analysis of the Mitchelstown Cohort Rescreen study, a random sample of 1,354 men and women aged 51–77 years recruited from a single primary care centre. BMI self-selection was measured by asking patients to select their BMI category: underweight, normal weight, overweight, obese. Weight and height were also objectively measured. Results 79% were overweight or obese: 86% of males, 69% of females (P Conclusions BMI self-selection may be useful for self-reporting BMI. Clinicians need to be aware of disparities between BMI self-selection at higher and lower BMI levels among overweight/obese patients and encourage preventative action for those at the lower levels to avoid weight gain and thus reduce their all-cause mortality risk.

We summarize how practicing dietitians combined available evidence with clinical experience, to define revised dietary recommendations for phosphorus in chronic kidney disease G3-5D. As well as a review of the evidence base, 4 priority topics were reviewed. These were translated into 3 nutrient level recommendations: the introduction of some plant protein where phosphorus is largely bound by phytate; consideration of protein intake in terms of phosphorus load and the phosphorus to protein ratio; and an increased focus on avoiding phosphate additives. This review summarizes and interprets the available evidence in order to support the development of practical food-based advice for patients with chronic kidney disease.

Introduction The standard low-phosphorus diet restricts pulses, nuts, and whole grains and other high phosphorus foods to control hyperphosphatemia. We conducted a randomized controlled trial to evaluate the effectiveness, safety, and tolerability of the modified diet, which introduced some pulses and nuts, increased the use of whole grains, increased focus on the avoidance of phosphate additives, and introduced the prescription of low-biological-value protein such as bread. Methods We conducted a multicenter, pragmatic, parallel-arm, open-label, randomized controlled trial of modified versus standard diet in 74 adults on hemodialysis with hyperphosphatemia over 1 month. Biochemistry was assessed using monthly laboratory tests. Dietary intake was assessed using a 2-day record of weighed intake of food, and tolerability was assessed using a patient questionnaire. Results There was no significant difference in the change in serum phosphate between the standard and modified diets. Although total dietary phosphorus intake was similar, phytate-bound phosphorus, found in pulses, nuts, and whole grains, was significantly higher in the modified diet (P Conclusion The modified low phosphorus diet was well tolerated and was associated with similar phosphate and potassium control but with a wider food choice and greater fiber intake than the standard diet.

Background Research into the association between childhood sexual abuse (CSA) and self-harm repetition is limited. Aims We aimed to examine the association between self-harm repetition, mental health conditions, suicidal intent and CSA experiences among people who frequently self-harm. Method A mixed-methods study was conducted including consecutive patients aged ≥18 years, with five or more self-harm presentations, in three Irish hospitals. Information was extracted from psychiatric records and patients were invited to participate in a semi-structured interview. Data was collected and analysed with a mixed-methods, convergent parallel design. In tandem, the association between CSA and self-harm repetition, suicidal intent and mental health conditions was examined with logistic regression models and independent sample t-test, with psychiatric records data. Thematic analysis was conducted with interview data, to explore CSA experiences and self-harm repetition. Results Between March 2016 and July 2019, information was obtained on 188 consecutive participants, with 36 participants completing an interview. CSA was recorded in 42% of the total sample and 72.2% of those interviewed. CSA was positively associated with self-harm repetition (odds ratio 6.26, 95% CI 3.94−9.94, P = 0.00). Three themes emerged when exploring participants’ CSA experiences: CSA as a precipitating factor for self-harm, secrecy of CSA accentuating shame, and loss experiences linked to CSA and self-harm. Conclusions CSA was frequently reported among people who frequently self-harm, and associated with self-harm repetition. Identification of patients at risk of repetition is key for suicide prevention. This is an at-risk group with particular characteristics that must be considered; comprehensive patient histories can help inform and tailor treatment pathways.

Background Measuring the quality and effectiveness of antimicrobial stewardship (AMS) programmes with quality indicators (QIs) is an area of increasing interest. We conducted a systematic review to identify QIs of AMS programmes in the hospital setting and critically appraise their methodological quality. Methods We searched the Cochrane Library, PubMed, MEDLINE, EMBASE, CINAHL, Scopus/web of science databases and the grey literature for studies that defined and/or described the development process and characteristics of the QIs developed. The Appraisal of Indicators through Research and Evaluation (AIRE) instrument was used to critically appraise the methodological quality of the QI sets. Results We identified 16 studies of QI sets consisting of 229 QIs. The QI sets addressed a broad range of areas of AMS in the hospital setting and consisted of 75% process indicators, 24% structural indicators and 1% outcome indicators. There was a wide variation in the information and level of detail presented describing the methodological characteristics of the QI sets identified. Conclusions The QIs identified in this study focused on process and structural indicators with few outcome indicators developed—a major deficiency in this area. Future research should focus on the development of outcome indicators or the use of process or structural indicators linked to outcomes to assess AMS. Testing of the QIs in practice is an essential methodological element of the QI development process and should be included in the QI development study or as planned validation work.

Purpose: The purpose of this study was to explore the knowledge, attitudes and practices of health professionals working in clinical trials, to pharmacovigilance and adverse drug reaction (ADR) reporting. Methods: A mixed methods study comprising an online questionnaire disseminated from September to November 2018, three semi-structured interviews and four focus groups. The qualitative components were conducted with a random sample of questionnaire participants who had provided their contact details (n = 24). The qualitative interviews were conducted at a location convenient to the participant’s place of work between October and December 2018. Results: One hundred forty-eight participants completed the questionnaire. Study coordinators/project managers represented the largest group of participants ( 28.6%, n = 38). Poor knowledge or understanding of ADR reporting was the most frequently cited barrier to ADR reporting (75%, n = 93). The most common enabler to reporting was having a clear understanding of an ADR definition (85.7%, n = 108). Focus group and interview participants described having limited staff as a barrier to reporting an ADR. They welcomed the prospect of pharmacovigilance training and indicated that face-to-face training would be preferred to provision of online training. Conclusion: This study highlights key factors that influence the reporting of ADRs in clinical trials. Although the findings are specifically related to the clinical trial environment in Ireland, they may provide a useful platform for optimising the future conduct of trials. This research suggests that ADR reporting may be improved through provision of enhanced pharmacovigilance training to clinical trial staff.

Background Successful antimicrobial stewardship interventions are imperative in today’s environment of antimicrobial resistance. New antimicrobial stewardship interventions should include qualitative analysis such as a process evaluation to determine which elements within an intervention are effective and provide insight into the context in which the intervention is introduced. Objective To assess the implementation process and explore the contextual factors which influenced implementation. Setting An academic teaching hospital in Cork, Ireland. Methods A process evaluation was conducted on completion of a feasibility study of the introduction of a procalcitonin antimicrobial stewardship intervention. The process evaluation consisted of semi-structured face-to-face interviews of key stakeholders including participating (senior) doctors (5), medical laboratory scientists (3) and a hospital administrator. The Consolidated Framework for Implementation Research was used to guide data collection, analysis, and interpretation. Main outcome measures Qualitative assessment of the intervention implementation process, the contextual factors which influenced implementation and identification of improvements to the intervention and its implementation and determine if proceeding to a randomised controlled trial would be appropriate. Results Analysis of the interviews identified three main themes. (1) The procalcitonin intervention and implementation process was viewed positively to support prescribing decisions. Participants identified modifications to procalcitonin processing and availability to improve implementation and allow procalcitonin to be “more of a clinical influence”. (2) In the antimicrobial stewardship context the concept of fear of missing an infection and risks of potentially serious outcomes for patients emerged. (3) The hospital context consisted of barriers such as available resources and facilitators including the hospital culture of quality improvement. Conclusion This process evaluation provides a detailed analysis of the implementation of procalcitonin testing as an antimicrobial stewardship intervention. The positive findings of this process evaluation and feasibility study should be built upon and a full randomised controlled trial and economic evaluation should be conducted in a variety of hospital settings to confirm the effectiveness of procalcitonin as an antimicrobial stewardship intervention.

Background Previous self-harm is one of the strongest predictors of future self-harm and suicide. Increased risk of repeated self-harm and suicide exists amongst patients presenting to hospital with high-risk self-harm and major self-harm repeaters. However, so far evidence-based training in the management of self-harm for mental health professionals is limited. Within this context, we aim to develop, implement and evaluate a training programme, SAMAGH, Self-harm Assessment and Management Programme for General Hospitals in Ireland. SAMAGH aims to (a) reduce hospital-based self-harm repetition rates and (b) increase rates of mental health assessments being conducted with self-harm patients. We also aim to evaluate the training on self-harm knowledge, attitudes, and skills related outcomes of healthcare professionals involved in the training. Methods/design The study will be conducted in three phases. First, the SAMAGH Training Programme has been developed, which comprises two parts: 1) E-learning Programme and 2) Simulation Training. Second, SAMAGH will be delivered to healthcare professionals from general hospitals in Ireland. Third, an outcome and process evaluation will be conducted using a pre-post design. The outcome evaluation will be conducted using aggregated data from the National Self-Harm Registry Ireland (NSHRI) on self-harm repetition rates from all 27 public hospitals in Ireland. Aggregated data based on the 3-year average (2016, 2017, 2018) self-harm repetition rates prior to the implementation of the SAMAGH will be used as baseline data, and NSHRI data from 6 and 12 months after the implementation of SAMAGH will be used as follow-up. For the process evaluation, questionnaires and focus groups will be administered and conducted with healthcare professionals who completed the training. Discussion This study will contribute to the evidence base regarding the effectiveness of an evidence informed training programme that aims to reduce repeated hospital self-harm presentations and to improve compliance with self-harm assessment and management. This study is also expected to contribute to self-harm and suicide training with the possibility of being translated to other settings. Its feasibility will be evaluated through a process evaluation.

The control of hyperphosphatemia is key to the management of chronic kidney disease mineral and bone disorder. Dietary restriction of phosphorus is essential to control hyperphosphatemia. Guidelines for chronic kidney disease and end-stage kidney disease generally provide high-level guidance on whether a nutrient should be restricted e.g, restrict dietary phosphorus. Dietitians translate such guidance into nutrient-based strategies and finally into food-based practical dietary advice for patients to follow. The practical aspects of dietary advice are not well described in the literature, neither are the challenges of concurrently altering 1 nutrient e.g., phosphorus while continuing to restrict others e.g., potassium, while maintaining overall nutritional adequacy and quality of life. In this article, we describe how we translated updated nutrient level recommendations into practical dietary advice to be delivered at the bedside.

Alcohol consumption is the number one public health concern in the university student population. The heterogeneous nature of university students’ consumption has recently been highlighted. Thus, the aim of the current research was to use latent class analysis to employ a person centred approach to describe alcohol consumption among university students with particular reference to gender. Questionnaires were distributed to students attending lectures in randomly selected degrees in one university. A total of 2332 self-completed questionnaires were obtained, yielding a response rate of 84%. Latent class analysis was conducted. In total, 830 men and 1367 women were analysed separately to uncover latent class structures. Harms, attitudes and consumption patterns were included in a model totalling to 26 variables. A 3-class structure best described men, while a 4-class structure best described women. Both men and women reported a class of “Guarded Drinkers”, “Responsible Conformers” and “Realistic Hed...

BackgroundWe know that parents require resources which can assist them to improve fever knowledge and management practices. The purpose of this study, using an RCT, was to examine the effectiveness of an information leaflet at increasing parental knowledge of fever, specifically temperature definition.MethodsA prospective, multi-centre, randomised, two-parallel arm, controlled trial with blinded outcome ascertainment was conducted. Parents presenting at purposively selected healthcare facilities who had a child aged ≤5 years of age were invited to participate. An information leaflet for use in the trial was designed based on previous studies with parents. Parents in the intervention arm read an information leaflet on fever and management of fever in children, completed a short questionnaire at Time 1 (T1) and again 2 weeks after randomisation at Time 2 (T2). Parents in the control arm did not receive the fever information leaflet but completed the same questionnaire as the intervention arm at T1 and againat T2. The primary outcome was the correct definition of fever (higher than ≥38 °C).ResultsA total of 100 parents participated in the study at T1. A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature (≥38 °C) at T1. 76% of the intervention arm correctly identified “higher than ≥38°C” as the temperature at which a fever is said to be present compared to 28% of the control arm. After 2 weeks, there was an increase of 6% of parents in the intervention arm (increase to 82.4%) who gave the correct temperature compared to just a 2.8% increase in the control arm (increase to 30.8%). Univariate logistic regression showed that parents in the intervention arm were significantly more likely to give the correct answer at both time-points (T1: OR 8.1; CI 95% 3.3–19.9:p p ConclusionsOur RCT of this simple educational intervention has been shown to improve parental understanding of fever knowledge and correct management strategies. Education interventions providing simple, clear information is a key step to decreasing parental mismanagement of fever and febrile illness in children.Trial registrationClinicalTrials.govNCT02903342, September 16, 2016, Retrospectively registered.

Background Diagnostic uncertainty and a high prevalence of viral infections present unique challenges for antimicrobial prescribing for respiratory tract infections (RTIs). Procalcitonin (PCT) has been shown to support prescribing decisions and reduce antimicrobial use safely in patients with RTIs, but recent study results have been variable. Methods We conducted a feasibility study of the introduction of PCT testing in patients admitted to hospital with a lower RTI to determine if PCT testing is an effective and worthwhile intervention to introduce to support the existing antimicrobial stewardship (AMS) programme and safely decrease antimicrobial prescribing in patients admitted with RTIs. Results A total of 79 patients were randomized to the intervention PCT-guided treatment group and 40 patients to the standard care respiratory control group. The addition of PCT testing led to a significant decrease in duration of antimicrobial prescriptions (mean 6.8 versus 8.9 days, P = 0.012) and decreased length of hospital stay (median 7 versus 8 days, P = 0.009) between the PCT and respiratory control group. PCT did not demonstrate a significant reduction in antimicrobial consumption when measured as DDDs and days of therapy. Conclusions PCT testing had a positive effect on antimicrobial prescribing during this feasibility study. The successful implementation of PCT testing in a randomized controlled trial requires an ongoing comprehensive education programme, greater integration into the AMS programme and delivery of PCT results in a timely manner. This feasibility study has shown that a larger randomized controlled trial would be beneficial to further explore the positive aspects of these findings.

Background: It is challenging to measure BMI accurately in population studies because it is an expensive and time-consuming task. As a result, subjectively measured BMI, calculated from self-reported height and weight, which we know to be inaccurate, is often used. The purpose of this study is to determine whether using a different, subjective method of measuring BMI, BMI self-selection, would be more accurate. BMI self-selection is determined by asking participants to place themselves in one of the BMI categories, underweight, normal weight, overweight or obese. Methods: A quantitative survey conducted in the outpatient departments of two hospitals in the South West of Ireland. Participants >18 years were included. Pregnant women were excluded. The final sample included 70 participants. Survey completion, including self-reported height and weight and BMI self-selection, preceded the objectively measured weight and height. Demographic and lifestyle factors were also recorded. Results: 59% of the sample were overweight or obese –63% of females and 54% of males. The sensitivity for correct BMI self-selection for normal weight, overweight and obese categories was 90%, 36% and 33% respectively. The sensitivity for BMI categories calculated from self-reported height and weight was 83%, 57% and 59% respectively. In analysis, age, regular alcohol consumption, unhealthy diet and lower levels of physical activity were all associated with underestimation of BMI. Conclusion: BMI self-selection is an accurate tool when used with normal weight individuals but shows poorer ability to demonstrate accurate measurement in overweight and obese BMI categories. It is inferior to the traditional self-reported BMI method for measuring BMI levels in the general population. Presently, we recommend continuing with self-reported BMI for BMI measurement in large population studies. However, further testing of BMI classification in larger studies is suggested and investigation into alternative objective methods of measurement is warranted.

The success of childhood weight management programmes relies on family engagement. While attendance offers many benefits including the support to make positive lifestyle changes, the majority of families referred to treatment decline. Moreover, for those who do attend, benefits are often compromised by high programme attrition. This systematic review investigated factors influencing attendance at community-based lifestyle programmes among families of overweight or obese children. A narrative synthesis approach was used to allow for the inclusion of quantitative, qualitative and mixed-method study designs. Thirteen studies met the inclusion criteria. Results suggest that parents provided the impetus for programme initiation, and this was driven largely by a concern for their child's psychological health and wellbeing. More often than not, children went along without any real reason or interest in attending. Over the course of the programme, however, children's positive social experiences such as having fun and making friends fostered the desire to continue. The stigma surrounding excess weight and the denial of the issue amongst some parents presented barriers to enrolment and warrant further study. This study provides practical recommendations to guide future policy makers, programme delivery teams and researchers in developing strategies to boost recruitment and minimise attrition.

Background: Currently, alcohol consumption levels are significantly higher among younger age groups. However, previous research has noted the diversity of motivations and patterns. These patterns of drinking have yet to be synthesised into a typology. The aim of the current study was to synthesise information from studies that produced types of alcohol consumption among young people. Method: Quantitative and qualitative literature investigating the different types of drinkers among young people [aged 12–24 years], published in peer reviewed journals, were eligible for inclusion in this systematic review. MEDLINE, PsychInfo and CINAHL were systematically searched for relevant articles published between January 1st 2000 and December 31st 2014. Included papers were critically appraised. A narrative synthesis approach was employed based on guidance from the UK Economic and Social Research Council. Results: In total, 13 studies were eligible for inclusion: 11 quantitative, one qualitative and one mixed methods. Six classes of drinkers were formed within this typology. Abstainers reported no alcohol consumption. Light drinkers reported drinking small amounts of alcohol infrequently. In comparison, social and hedonistic drinkers drank most in social situations and to have fun. Heavy and harmful consumers reported increased volume and frequency of consumption including harmful consequences. Conclusion: Currently, policy makers are attempting to combat the high levels of harmful alcohol consumption among young people. The current typology provides guidance for targeted interventions in addition to a practical analytic tool in future research.

Background Hypodermic needles of different sizes (gauges and lengths) can be used for vaccination procedures. The gauge (G) refers to the outside diameter of the needle tubing. The higher the gauge number, the smaller diameter of the needle (eg a 25 G needle is 0.5 mm in diameter and is narrower than a 23 G needle (0.6 mm)). Many vaccines are recommended for injection into muscle (intramuscularly), although some are delivered subcutaneously (under the skin) and intradermally (into skin). Choosing an appropriate length and gauge of a needle may be important to ensure that a vaccine is delivered to the appropriate site and produces the maximum immune response while causing the least possible harm. There are some conflicting guidelines regarding the lengths and gauges of needles that should be used for vaccination procedures in children and adolescents. Objectives To assess the effects of using needles of different lengths and gauges for administering vaccines to children and adolescents on vaccine immunogenicity (the ability of the vaccine to elicit an immune response), procedural pain, and other reactogenicity events (adverse events following vaccine administration). Search methods We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2014, Issue 10), MEDLINE and MEDLINE in Progress via Ovid (1947 to November 2014), EMBASE via Ovid (1974 to November 2014), and CINAHL via EBSCOhost (1982 to November 2014). We also searched reference lists of articles and textbooks, the proceedings of vaccine conferences, and three clinical trial registers. Selection criteria Randomised controlled trials evaluating the effects of using hypodermic needles of any gauge or length to administer any type of vaccine to people aged from birth to 24 years. Data collection and analysis Three review authors independently extracted trial data and assessed the risk of bias. We contacted trial authors for additional information. We rated the quality of evidence using the GRADE system. Main results We included five trials involving 1350 participants. Data for the primary review outcomes were either absent (for the incidence of vaccine-preventable diseases) or limited (for procedural pain and crying). The available evidence was compromised by the use of surrogate immunogenicity outcomes, incomplete blinding of outcome assessors, and imprecision for some outcomes. The evidence from two small trials was insufficient to allow any confident statements to be made about the effects of the needles evaluated in the trials on vaccine immunogenicity and reactogenicity. The remaining three trials (1135 participants) contributed data to comparisons between 25 G 25 mm, 23 G 25 mm, and 25 G 16 mm needles. These trials involved infants predominantly aged two to six months undergoing intramuscular vaccination in the anterolateral thigh using the World Health Organization (WHO) injection technique (skin stretched flat, needle inserted at a 90° angle and up to the needle hub in healthy infants). The vaccines administered were combination vaccines containing diphtheria, tetanus, and whole-cell pertussis antigens (DTwP). In some trials, the vaccines also contained Haemophilus influenzae type b (DTwP-Hib) and hepatitis B (DTwP-Hib-HepB) antigen components. We found moderate quality evidence from one trial that there is probably little or no difference in immune response, defined in terms of the proportion of seroprotected infants, between using 25 G 25 mm, 23 G 25 mm, or 25 G 16 mm needles to administer a series of three doses of a DTwP-Hib vaccine at ages two, three, and four months (numbers of participants in analyses range from 309 to 402. Immune response to pertussis antigen not measured). 25 mm needles (either 23 G or 25 G) probably lead to fewer severe local reactions (extensive redness and swelling) and fewer non-severe local reactions (any redness, swelling, tenderness or hardness (composite outcome)) after DTwP-Hib vaccination compared with 25 G 16 mm needles. We estimate that one fewer infant will experience a severe local reaction after the first vaccine dose for every 25 infants vaccinated with the longer rather than the shorter needle (number needed to treat (NNT) 25 (95% confidence interval (CI) 15 to 100)). We estimate that one fewer infant will experience a non-severe local reaction at 24 hours after the first, second, and third vaccine doses for every five to eight infants vaccinated with the longer rather than the shorter needle (NNTs range from 5 (95% CI 4 to 10) to 8 (95% CI 5 to 34)) (moderate quality evidence, one trial for first and second doses, two trials for third dose, numbers of participants in analyses range from 413 to 528). Using a wider gauge needle (23 G 25 mm) may slightly reduce procedural pain (low quality evidence) and probably leads to a slight reduction in the duration of crying time immediately after vaccination (moderate quality evidence) compared with a narrower gauge (25 G 25 mm) needle (one trial, 320 participants). The effects are probably not large enough to be of any clinical relevance. The 25 G 25 mm needle may produce a small reduction in the incidence of local reactions after each dose of a DTwP vaccine compared with the 23 G 25 mm needle, but the effect estimates are imprecise (low quality evidence, two trials, numbers of participants in analyses range from 100 to 459). The comparative effects of 23 G 25 mm, 25 G 25 mm, and 25 G 16 mm needles on the incidence of post-vaccination fever, persistent inconsolable crying, and other systemic events such as drowsiness, loss of appetite, and vomiting are uncertain due to the very low quality of the evidence. Authors' conclusions Using 25 mm needles (either 23 G or 25 G) for intramuscular vaccination procedures in the anterolateral thigh of infants using the WHO injection technique probably reduces the occurrence of local reactions while achieving a comparable immune response to 25 G 16 mm needles. These findings are applicable to healthy infants aged two to six months receiving combination DTwP vaccines with a reactogenic whole-cell pertussis antigen component. These vaccines are predominantly used in developing countries. The applicability of the findings to vaccines with acellular pertussis components and other vaccines with different reactogenicity profiles is uncertain.

Background In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a ‘gold standard’, validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists’ readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland. Methods This is a mixed-methods, explanatory sequential design, with quantitative survey followed by semistructured interviews. Academic clinical researchers (N = 132) working in Ireland were surveyed to examine their use and perceptions of RBM. A purposive sample of survey participants (n = 22) were then interviewed to gain greater insight into the quantitative findings. The survey and interview data were merged to generate a list of perceived barriers and facilitators to RBM implementation, with suggestions for, and solutions to, these issues. Results Survey response rate was 49% (132/273). Thirteen percent (n = 18) of responders were not familiar with the term risk-based monitoring and less than a quarter of respondents (21%, n = 28) had performed RBM in a clinical trial. Barriers to RBM implementation included lack of RBM knowledge/training, increased costs caused by greater IT demands, increased workload for trial staff and lack of evidence to support RBM as an effective monitoring approach. Facilitators included participants’ legal obligation to perform RBM under the new ICH-GCP guidelines, availability of RBM guidance and perception of cost savings by performing RBM in future trials. Conclusion The results of this study demonstrate a need for training and regulatory-endorsed guidelines to support the implementation of RBM in academic-led clinical trials. The study provides valuable insights to inform interventions and strategies by policy-makers and clinical trial regulators to improve RBM uptake. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2148-4) contains supplementary material, which is available to authorized users.

peer-reviewed Objective The burden of sexually transmitted infections (STIs) rests with young people, yet in Ireland there has been very little research into this population. The purpose of this study was to determine the incidence rate and establish risk factors that predict STI occurrence among adolescents in Ireland. Design Routine diagnostic, demographic and behavioural data from first-time visits to three screening centres in the southwest of Ireland were obtained. Univariate and multivariable logistic regression models were used to assess risk factors that predict STI occurrence among adolescents. Results A total of 2784 first-time patients, aged 13–19 years, received 3475 diagnoses between January 1999 and September 2009; 1168 (42%) of adolescents had notifiable STIs. The incidence rate of STIs is 225/100 000 person-years. Univariate analysis identified eligible risk factors (p

Background Fever is one of the most common childhood symptoms. It causes significant worry and concern for parents. Every year there are numerous cases of over- and under-dosing with antipyretics. Caregivers seek reassurance from a variety of sources including healthcare practitioners. The aim of this study was to describe parental knowledge, attitudes and beliefs regarding management of childhood fever in children aged 5 years and under. Method Semi-structured interviews were conducted with 23 parents at six ante-natal clinics in the south west of Ireland during March and April 2015. The Francis method was used to detect data saturation and thereby identify sample size. Thematic analysis was used to analyse the data. Results Twenty-three parents participated in the study. Five themes emerged from the data: assessing and managing the fever; parental knowledge and beliefs regarding fever; knowledge source; pharmaceutical products; initiatives. Parents illustrated a good knowledge of fever as a symptom. However, management practices varied between participants. Parents revealed a reluctance to use medication in the form of suppositories. There was a desire for more accessible, consistent information to be made available for use by parents when their child had a fever or febrile illness. Conclusion Parents indicated that further initiatives are required to provide trustworthy information on the management of fever and febrile illness in children. Healthcare professionals should play a significant role in educating parents in how to manage fever and febrile illnesses in their children. The accessible nature and location of pharmacies could provide useful support for both parents and General Practitioners.

Introduction In November 2016, the Integrated Addendum to ICH-GCP E6 (R2) will advise trial sponsors to develop a risk-based approach to clinical trial monitoring. This new process is commonly known as risk based monitoring (RBM). To date, a variety of tools have been developed to guide RBM. However, a gold standard approach does not exist. This review aims to identify and examine RBM tools. Methods Review of published and grey literature using a detailed search-strategy and cross-checking of reference lists. This review included academic and commercial instruments that met the Organisation for Economic Co-operation and Development (OECD) classification of RBM tools. Results Ninety-one potential RBM tools were identified and 24 were eligible for inclusion. These tools were published between 2000 and 2015. Eight tools were paper based or electronic questionnaires and 16 operated as Service as a System (SaaS). Risk associated with the investigational medicinal product (IMP), phase of the clinical trial and study population were examined by all tools and suitable mitigation guidance through on-site and centralised monitoring was provided. Conclusion RBM tools for clinical trials are relatively new, their features and use varies widely and they continue to evolve. This makes it difficult to identify the “best” RBM technique or tool. For example, equivalence testing is required to determine if RBM strategies directed by paper based and SaaS based RBM tools are comparable. Such research could be embedded within multi-centre clinical trials and conducted as a SWAT (Study within a Trial).

Background Fever is one of the most common childhood symptoms and accounts for numerous consultations with healthcare practitioners. It causes much anxiety amongst parents as many struggle with managing a feverish child and find it difficult to assess fever severity. Over- and under-dosing of antipyretics has been reported. Aim of the review The aim of this review was to synthesise qualitative and quantitative evidence on the knowledge, attitudes and beliefs of parents regarding fever and febrile illness in children. Method A systematic search was conducted in ten bibliographic databases from database inception to June 2014. Citation lists of studies and consultation with experts were used as secondary sources to identify further relevant studies. Titles and abstracts were screened for inclusion according to pre-defined inclusion and exclusion criteria. Quantitative studies using a questionnaire were analysed using narrative synthesis. Qualitative studies with a semi-structured interview or focus group methodology were analysed thematically. Results Of the 1565 studies which were screened for inclusion in the review, the final review comprised of 14 studies (three qualitative and 11 quantitative). Three categories emerged from the narrative synthesis of quantitative studies: (i) parental practices; (ii) knowledge; (iii) expectations and information seeking. A further three analytical themes emerged from the qualitative studies: (i) control; (ii) impact on family; (iii) experiences. Conclusion Our review identifies the multifaceted nature of the factors which impact on how parents manage fever and febrile illness in children. A coherent approach to the management of fever and febrile illness needs to be implemented so a consistent message is communicated to parents. Healthcare professionals including pharmacists regularly advise parents on fever management. Information given to parents needs to be timely, consistent and accurate so that inappropriate fever management is reduced or eliminated. This review is a necessary foundation for further research in this area.

The gold standard for categorisation of weight status is clinically measured body mass index (BMI), but this is often not practical in large epidemiological studies.To determine if a child's weight perception or a mother's perception of a child's weight status is a viable alternative to measured height and weight in determining BMI classification. Secondary outcomes are to determine the influence of a mother's BMI on her ability to categorise the child's BMI and a child's ability to recognise his/her own BMI.Cross-sectional analysis of the growing up in Ireland cohort study, a nationally representative cohort of 8568 9-year-old children. The variables considered for this analysis are the child's gender, BMI (International Obesity Taskforce grade derived from measured height and weight) and self-perceived weight status, and the mother's weight perception of the child, BMI (derived from measured height and weight) and self-perceived weight status. Cohen's weighted-kappa was used to evaluate the strength of the agreement between pairwise combinations of the BMI variables. Cumulative and adjacent categories logistic regression were used to predict how likely a person rates themselves as under, normal or overweight, based on explanatory variables.Mothers are more accurate at correctly classifying their child's BMI (κ=0.5; confidence intervals (CI) 0.38-0.51) than the children themselves (κ=0.25; CI 0.23-0.26). Overweight mothers are better raters of their child's BMI (κ=0.51; CI 0.49-0.54), compared with normal (κ=0.44; CI 0.41-0.47) or underweight mothers (κ=0.4; CI 0.22-0.58), regardless of whether the mother's BMI is derived from measured height and weight or self-perceived. The mother's perception of the child's weight status is not an influencing factor on the child's ability to correctly classify him/herself, but the child's self-perceived weight status influences the mother's ability to correctly classify the child.A mother's BMI classification of her child is a viable alternative to BMI measurement in large epidemiological studies.

In routine clinical practice, mattresses are manually cleaned using specialised cleaning and high-level disinfecting fluids. While effective against a wide range of organisms, the success of this approach is dependent on a thorough and complete application and is likely to be susceptible to human error and thus variable. The efficacy of available infection control measures to reduce such mattress contamination is unknown as it is not subject to quality control measures. There is a pressing need to identify more effective methods to prevent cross contamination within the medical environment, given the lack of available treatment strategies.The purpose of this study is to investigate the ability of a new technology, gaseous technology, to reduce colonization levels, compared to standard cleaning, and so attenuate superficial nosocomial infections.We conducted a prospective, single-centre, open-label, non-randomized trial with blinded outcome assessments, comparing the standard cleaning of hospital mattresses with a novel plasma based disinfection system Radica™, followed by a standard post-cleaning culturing protocol (five swabs/mattress).The median (interquartile range) maximal colony count per mattress for the 20 Radica versus 7 routinely cleaned mattresses was 1 (1-2.7) versus Too-Numerous-to-Count (TNTC) (32-TNTC), respectively, p = 0.002. Of the 20 Radica™ treated mattresses, 12 (60 %) had no positive culture result while all of the standard cleaned mattresses had at least two positive cultures.The plasma based Radica disinfection system reduces mattress bacterial colonization levels as compared to routine cleaning. This is a potentially important technology in the health care system to reduce surface colonisation and hence nosocomial infections.

Background Alcohol is a leading cause of global suffering. Europe reports the uppermost volume of alcohol consumption in the world, with Ireland and the United Kingdom reporting the highest levels of binge drinking and drunkenness. Levels of consumption are elevated among university students. Thus, this literature review aims to summarise the current research on alcohol consumption among university students in the Republic of Ireland and the United Kingdom. Methods MEDLINE, CINAHL, EMBASE and PsychInfo were systematically searched for literature from January 2002 until December 2014. Each database was searched using the following search pillars: alcohol, university student, Ireland or the United Kingdom and prevalence studies. Results Two thousand one hundred twenty eight articles were retrieved from electronic database searching. These were title searched for relevance. 113 full texts were retrieved and assessed for eligibility. Of these, 29 articles were deemed to meet inclusion criteria for the review. Almost two thirds of students reported a hazardous alcohol consumption score on the AUDIT scale. Over 20 % reported alcohol problems over their lifetime using CAGE while over 20 % exceed sensible limits each week. Noteworthy is the narrowing of the gender gap throughout the past decade. Conclusion This is the first review to investigate consumption patterns of university students in Ireland and the United Kingdom. A range of sampling strategies and screening tools are employed in alcohol research which preclude comparability. The current review provides an overview of consumption patterns to guide policy development.

Aim Fever and febrile illness are some of the most common conditions managed by parents. The aim of this study was to examine the knowledge, attitudes and beliefs of parents around fever in children under five years of age. Methods Between July and August 2014, a convenience sample of parents was invited to participate in this study in Copenhagen, Denmark. Results were analysed thematically using a constant comparison method. Results Twenty-one parents participated in the study. Five themes emerged from the data: parental concern, help-seeking behaviour, parental knowledge, parent fever management practices and initiatives. Parents used a range of information sources to obtain their knowledge on management of fever; however, due to issues of trust with these sources, reassurance was often sought from healthcare practitioners. There was a desire amongst most parents for initiatives to be introduced which provide general information on how to manage fever in children. Conclusion Parents were very concerned when their child was febrile and instigated practices obtained from accessible information sources. This study has identified a need for specific and reliable information initiatives to be introduced as a means of reducing parental concern and ensuring evidence-based strategies for managing a child with fever.

ObjectiveTo explore the barriers and facilitators experienced by those implementing a government-funded, community-based childhood weight management programme.DesignQualitative using semistructured interviews.SettingTwo geographical regions in the south and west of Ireland.Participants29 national-level and local-level stakeholders responsible for implementing the programme, including professionals from dietetics, psychology, public health nursing, physiotherapy, health promotion and administration.MethodsFramework analysis was used to identify barriers and facilitators, which were mapped onto six levels of factors influencing implementation outlined by Grol and Wensing: the innovation, the individual professional, the patient, the social context, the organisational context and the external environment.ResultsMost barriers occurred at the level of the organisational context. For all stakeholders, barriers arose due to the multidisciplinary nature of the programme, including the lack of role clarity and added complexity of working in different locations. Health professionals’ low-perceived self-efficacy in approaching the subject of weight with parents and parental resistance to hearing about their child’s weight status were barriers to programme implementation at the individual professional and patient levels, respectively. The main facilitators of implementation, occurring at the level of the health professional, included stakeholders’ recognition of the need for a weight management programme and personal interest in the area of childhood obesity. Having a local lead and supportive colleagues were further implementation drivers.ConclusionsThis study highlights the complexities associated with implementing a multidisciplinary childhood weight management programme, particularly translating such a programme to a community setting. Our results suggest the assignment of clear roles and responsibilities, the provision of sufficient practical training and resources, and organisational support play pivotal roles in overcoming barriers to change. This evidence can be used to develop an implementation plan to support the translation of interventions into real-world settings.

Objectives Fever is a common symptom of mostly benign illness in young children, yet concerning for parents. The aim of this study was to describe parental knowledge, attitudes and beliefs regarding fever in children aged ≤5 years of age. Design A cross-sectional study using a previously validated questionnaire. Results were analysed using descriptive statistics and multivariable logistic regression. Setting Purposively selected primary schools (n=8) in Cork, Ireland, using a paper-based questionnaire. Data were collected from a cross-sectional internet-based questionnaire with a convenience sample of parents via websites and web pages (n=10) previously identified in an interview study. Participants Parents with at least one child aged ≤5 years were invited to participate in the study. Main outcome measures Parental knowledge, attitudes and beliefs when managing fever in children. Results One thousand one hundred and four parents contributed to this research (121 parents from schools and 983 parents through an online questionnaire). Almost two-thirds of parents (63.1%) identified temperatures at which they define fever that were either below or above the recognised definition of temperature (38°C). Nearly two of every three parents (64.6%) alternate between two fever-reducing medications when managing a child’s fever. Among parents, years of parenting experience, age, sex, educational status or marital status did not predict being able to correctly identify a fever, neither did they predict if the parent alternated between fever-reducing medications. Conclusions Parental knowledge of fever and fever management was found to be deficient which concurs with existing literature. Parental experience and other sociodemographic factors were generally not helpful in identifying parents with high or low levels of knowledge. Resources to help parents when managing a febrile illness need to be introduced to help all parents provide effective care.

Background: Obesity is a growing problem worldwide and can often result in a variety of negative health outcomes. In this study we aim to apply partial least squares (PLS) methodology to estimate the separate effects of age, period and cohort on the trends in obesity as measured by body mass index (BMI). Methods: Using PLS we will obtain gender specific linear effects of age, period and cohort on obesity. We also explore and model nonlinear relationships of BMI with age, period and cohort. We analysed the results from 7,796 men and 10,220 women collected through the SLAN (Surveys of Lifestyle, attitudes and Nutrition) in Ireland in the years 1998, 2002 and 2007. Results: PLS analysis revealed a positive period effect over the years. Additionally, men born later tended to have lower BMI (�0.026 kg∙m -2 yr -1 , 95% CI: -0.030 to �0.024) and older men had in general higher BMI (0.029 kg∙m -2 yr -1 , 95% CI: 0.026 to 0.033). Similarly for women, those born later had lower BMI (�0.025 kg∙m -2 yr -1 , 95% CI: -0.029 to �0.022) and older women in general had higher BMI (0.029 kg∙m -2 yr -1 , 95%CI: 0.025 to 0.033). Nonlinear analyses revealed that BMI has a substantial curvilinear relationship with age, though less so with birth cohort. Conclusion: We notice a generally positive age and period effect but a slightly negative cohort effect. Knowing this, we have a better understanding of the different risk groups which allows for effective public intervention measures to be designed and targeted for these specific population subgroups.