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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract Background As the use of self-reported data to classify obesity continues, the temporal change in the accuracy of self-report measurement when compared to clinical measurement remains unclear. The objective of this study was to examine temporal trends in misclassification patterns, as well as sensitivity and specificity, of clinically measured versus self-report based body mass index (BMI) from three national lifestyle surveys over a 10-year period. Methods The Surveys of Lifestyle Attitudes and Nutrition (SLÁN) were interview based cross-sectional survey/measurements involving nationally representative samples in 1998, 2002 and 2007. Data from a subsample of both self-reported and measured height and weight were available from 66 men and 142 women in 1998, 147 men and 184 women in 2002 and 909 men and 1128 women in 2007. Respondents were classified into the BMI categories normal (< 25 kg m-2), overweight (25- < 30 kg m-2) and obese (≥ 30 kg m-2). Results Underreporting of BMI increased across the three surveys (14%→21%→24%; p = 0.002). Sensitivity scores for the normal category exceeded 94% in all three surveys but decreased for the overweight (75%→68%→66%) and obese categories (80%→64%→53%). Simultaneously, specificity levels remained high. Conclusions BMI values based on self-reported determinations of height and weight in population samples are underestimating the true prevalence of the obesity epidemic and this underestimation is increasing with time. The decreased sensitivity and consistently high specificity scores in the obese category across time, highlights the limitation of self-report based BMI classifications and the need for simple, readily comprehensible indicators of obesity.

Background: As the use of self-reported data to classify obesity continues, the temporal change in the accuracy of self-report measurement when compared to clinical measurement remains unclear. The objective of this study was to examine temporal trends in misclassification patterns, as well as sensitivity and specificity, of clinically measured versus self-report based body mass index (BMI) from three national lifestyle surveys over a 10-year period.Methods: The Surveys of Lifestyle Attitudes and Nutrition (SLÁN) were interview based cross-sectional survey/measurements involving nationally representative samples in 1998, 2002 and 2007. Data from a subsample of both self-reported and measured height and weight were available from 66 men and 142 women in 1998, 147 men and 184 women in 2002 and 909 men and 1128 women in 2007. Respondents were classified into the BMI categories normal (< 25 kg m⁻²), overweight (25- < 30 kg m⁻²) and obese (≥ 30 kg m⁻²).Results: Underreporting of BMI increased across the three surveys (14%→21%→24%; p = 0.002). Sensitivity scores for the normal category exceeded 94% in all three surveys but decreased for the overweight (75%→68%→66%) and obese categories (80%→64%→53%). Simultaneously, specificity levels remained high.Conclusions: BMI values based on self-reported determinations of height and weight in population samples are underestimating the true prevalence of the obesity epidemic and this underestimation is increasing with time. The decreased sensitivity and consistently high specificity scores in the obese category across time, highlights the limitation of self-report based BMI classifications and the need for simple, readily comprehensible indicators of obesity. [ABSTRACT FROM AUTHOR]

Introduction: Testicular cancer is among the most common malignancies in men under the age of 50 years. Most testicular symptoms are linked to benign diseases. Men's awareness of testicular diseases and testicular self-examination behaviours are suboptimal. In this pilot feasibility study and process evaluation we examine the feasibility of conducting a future definitive randomised controlled trial (RCT) to test the effect of the Enhancing Men's Awareness of Testicular Diseases using Virtual Reality intervention (E-MATVR) compared to the Enhancing Men's Awareness of Testicular Diseases using Electric information control (E-MATE). The study protocol is registered on ClinicalTrials.gov (NCT05146466)., Methods: Male athletes, engaged in Gaelic games, and aged 18 to 50 years were included. Recruitment was via FacebookTM, XTM (formerly TwitterTM), and posters. Participants were individually randomised to either E-MATVR or E-MATE. Data were collected at baseline (T0), immediately post-test (T1), and three months post-test (T2) using surveys. Qualitative interviews were conducted with participants and researchers., Results: Data were collected from 74 participants. Of those, 66 were retained. All E-MATVR participants and most E-MATE participants (n = 33, 89.2%) agreed/strongly agreed that the device was easy to use and that they were engaged to learn by the device. Most E-MATVR participants (n = 34, 91.9%) and all E-MATE participants agreed/strongly agreed that the time it took them to complete the intervention was reasonable. All 74 participants were extremely satisfied/somewhat satisfied with their overall participation in the study. E-MATVR was described as interactive, easy, fun, and close to real life. Initial difficulty using VR equipment, nausea, and technical issues were identified as challenges to engaging with E-MATVR. Recommendations were made to make VR more accessible, shorten the survey, and incorporate more interactivity. Across all participants, mean testicular knowledge scores (range 0-1) increased from 0.4 (SD 0.2) at T0 to 0.8 (SD 0.2) at T1. At T2, overall mean scores for participants were 0.7 (SD 0.2). Mean knowledge scores did not differ by trial arm at any timepoint. At T2, all E-MATVR participants and 29/32 E-MATE participants (90.6%) reported purposefully examining their testes within the past three months., Conclusion: Findings are promising, highlighting the feasibility of using VR to promote young athletes' awareness of testicular diseases. Considering the strengths, limitations, and lessons learned from this study, some modifications are required prior to conducing an RCT. These include but are not limited to shortening survey questions, incorporating more interactivity and visual content, and targeting more heterogenous male-dominated environments., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Saab et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback., Methods: We collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase., Results: Two hundred and eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases., Conclusions: Potential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice., (© 2024. The Author(s).)

Background: Registry-based randomised controlled trials (rRCTs) have been described as pragmatic studies utilising patient data embedded in large-scale registries to facilitate key clinical trial procedures including recruitment, randomisation and the collection of outcome data. Whilst the practice of utilising registries to support the conduct of randomised trials is increasing, the use of the registries within rRCTs is inconsistent. The purpose of this systematic review is to explore the conduct of rRCTs using a patient registry to facilitate trial recruitment and the collection of outcome data, and to discuss the advantages and challenges of rRCTs., Methods: A systematic search of the literature was conducted using five databases from inception to June 2020: PubMed, Embase (through Ovid), CINAHL, Scopus and the Cochrane Controlled Register of Trials (CENTRAL). The search strategy comprised of MESH terms and key words related to rRCTs. Study selection was performed independently by two reviewers. A risk of bias for each study was completed. A narrative synthesis was conducted., Results: A total 47,862 titles were screened and 24 rRCTs were included. Eleven rRCTs (45.8%) used more than one registry to facilitate trial conduct. Six rRCTs (25%) randomised participants via a specific randomisation module embedded within a registry. Recruitment ranged between 209 to 106,000 participants. Advantages of rRCTs are recruitment efficiency, shorter trial times, cost effectiveness, outcome data completeness, smaller carbon footprint, lower participant burden and the ability to conduct multiple trials from the same registry. Challenges are data collection/management, quality assurance issues and the timing of informed consent., Conclusions: Optimising the design of rRCTs is dependent on the capabilities of the registry. New registries should be designed and existing registries reviewed to enable the conduct of rRCTs. At all times, data management and quality assurance of all registry data should be given key consideration. We suggest the inclusion of the term 'registry-based' in the title of all rRCT manuscripts and a clear simple breakdown of the registry-based conduct of the trial in the abstract to facilitate indexing in the major databases., (© 2024. The Author(s).)

Background: Retaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure retention or improve it. Other than monetary incentives, there is no requirement to disclose the use of retention strategies to the participant. Additionally, not all retention strategies are developed at the planning stage, i.e. post-funding during protocol development, but some protocols include strategies for participant retention as retention is considered and planned for early in the trial planning stage. It is yet unknown if these plans are communicated in the corresponding participant information leaflets (PILs). The purpose of our study was to determine if PILs communicate plans to promote participant retention and, if so, are these outlined in the corresponding trial protocol., Methods: Ninety-two adult PILs and their 90 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate., Results: Plans to promote participant retention were communicated in 81.5% (n = 75/92) of PILs. Fifty-seven percent (n = 43/75) of PILs communicated plans to use "combined strategies" to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12/75 PILs). The importance of retention and the impact that missing or deleted data (deleting data collected prior to withdrawal) has on the ability to answer the research question were explained in 6.5% (n = 6/92) and 5.4% (n = 5/92) of PILs respectively. Out of the 59 PILs and 58 matching protocols that both communicated plans to use strategies to promote participant retention, 18.6% (n = 11/59) communicated the same information, the remaining 81.4% (n = 48/59) of PILs either only partially communicated (45.8%; n = 27/59) the same information or did not communicate the same information (35.6%; n = 21/59) as the protocol with regard to the retention strategy(ies)., Conclusion: Retention strategies are frequently communicated to potential trial participants in PILs; however, the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the planning stage of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL., (© 2024. The Author(s).)

Introduction: Increased awareness of testicular diseases can lead to early diagnosis. Evidence suggests that men's awareness of testicular diseases is low, with many expressing their willingness to delay help-seeking for symptoms of concern. The risk of testicular diseases is higher in gender and sexual minority groups. In this study, we discuss the codesign, refinement and launch of 'On the Ball', an inclusive community-based 'testicular awareness' campaign., Methods: The World Café participatory research methodology was used. Individuals from Lesbian, Gay, Bisexual, Transgender and Queer+ friendly organisations, testicular cancer survivors, policymakers, media/marketing experts and graphic designers were recruited. Participants were handed a brief for 'On the Ball', which was designed based on feedback from a previous World Café workshop. They were assigned to three tables. Participants rotated tables at random for three 20-min rounds of conversations. Each table had a facilitator who focussed on one element of the campaign brief. Data were collected using audio recorders and in writing and were analysed thematically., Results: Thirteen individuals participated in the workshop. The following themes emerged from the data: (i) campaign identity, (ii) campaign delivery and (iii) campaign impact. Participants recommended enhancements to the campaign logo, slogan, social media posts and poster. They suggested delivering the campaign online via social media and offline using various print and broadcast media. Participants recommended targeting areas with a large number of men such as workplaces. To help measure the impact of the campaign, participants proposed capturing social media analytics and tracking statistics relating to testicular diseases. Recommendations were used to refine the 'On the Ball' campaign and launch it in a university. In total, 411 students engaged with the various elements of the campaign during the soft launch., Conclusions: 'On the Ball' campaign visuals ought to be inclusive. Online and offline campaign delivery is warranted to reach out to a wider cohort. Campaign impact can be captured using social media analytics as well as measuring clinical outcomes relating to testicular diseases. Future research is needed to implement the campaign online and offline, explore its impact and evaluate its feasibility, acceptability, cost and effect on promoting testicular awareness., Patient or Public Contribution: The 'On the Ball' campaign was codesigned and refined with members of Lesbian, Gay, Bisexual, Transgender and Queer+ friendly organisations, testicular cancer survivors, health policymakers, media and marketing experts and graphic designers using the World Café participatory research methodology., (© 2024 The Author(s). Health Expectations published by John Wiley & Sons Ltd.)

Introduction: Smartwatches have become ubiquitous for tracking health metrics. These data sets hold substantial potential for enhancing healthcare and public health initiatives; it may be used to track chronic health conditions, detect previously undiagnosed health conditions and better understand public health trends. By first understanding the factors influencing one's continuous use of the device, it will be advantageous to assess factors that may influence a person's willingness to share their individual data sets. This study seeks to comprehensively understand the factors influencing the continued use of these devices and people's willingness to share the health data they generate., Methods and Analysis: A two-section online survey of smartwatch users over the age of 18 will be conducted (n ≥200). The first section, based on the expectation-confirmation model, will assess factors influencing continued use of smartwatches while the second section will assess willingness to share the health data generated from these devices. Survey data will be analysed descriptively and based on structural equation modelling.Subsequently, six focus groups will be conducted to further understand the issues raised in the survey. Each focus group (n=6) will consist of three smartwatch users: a general practitioner, a public health specialist and an IT specialist. Young smartwatch users (aged 18-44) will be included in three of the focus groups and middle-aged smartwatch users (aged 45-64) will be included in the other three groups. This is to enhance comparison of opinions based on age groups. Data from the focus groups will be analysed using the microinterlocutor approach and an executive summary.After the focus group, participants will complete a brief survey to indicate any changes in their opinions resulting from the discussion., Ethics and Dissemination: The results of this study will be disseminated through publication in a peer-reviewed journal, and all associated data will be deposited in a relevant, publicly accessible data repository to ensure transparency and facilitate future research endeavours.This study was approved by the Social Research Ethic Committee (SREC), University College Cork-SREC/SOM/21062023/2., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs)., Methods: A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third., Results: Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas., Conclusion: Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed., (© 2024. The Author(s).)