Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation.

BACKGROUND: Trials in pre-hospital trauma care are relatively uncommon. There are logistical and methodological challenges related to designing and delivering trials in this setting. Previous studies have assessed challenges reported in individual trials rather than across the pre-hospital trial landscape to identify over-arching factors. The aim of this study was to investigate the challenges and opportunities related to the set-up, design and conduct of pre-hospital trauma trials from across the pre-hospital trial landscape and a specific pre-hospital trauma feasibility study. METHODS: Semi-structured interviews were conducted with two cohorts of participants: research personnel who had experience of pre-hospital trials, either through direct involvement in conduct or through strategic oversight of national initiatives (n = 7), and clinical staff (n = 16) involved in recruitment to a pre-hospital trauma feasibility study. Thematic analyses were used to assess the barriers and enablers of conducting pre-hospital trauma trials. Two frameworks (The Capability Opportunity Motivation-Behaviour and the Theoretical Domains Framework) were used to guide analyses. RESULTS: The barriers and enablers reported were relevant to several TDF domains and COM-B components. Across both cohorts, challenges associated with opportunities were reported and included the lack of research experience amongst pre-hospital staff, team dynamics within a rotating shift schedule, and the involvement of external organisations with diverse institutional priorities and infrastructures (e.g. Air Ambulances). The infrequency of eligible cases was also reported to affect the trial design, set-up, and conduct. Other barriers reported related to clinical equipoise amongst staff and institutional pressures, which affected motivation. CONCLUSIONS: This study has highlighted that pre-hospital trials face many context-specific but also generic challenges. Pre-hospital trauma trial teams could consider the findings to develop targeted, behaviourally focused, solutions to the challenges identified in order to enhance the set-up and conduct of trials in this setting. TRIAL REGISTRATION: NCT04145271. Trial registration date: October 30, 2019. Note that this paper does not report results from a specific trial but does include participants who were involved in the conduct of a registered pre-hospital feasibility study.

Behavioural optimisation to address trial conduct challenges: case study in the UK-REBOA trial.

BACKGROUND: Clinical trials comprise multiple processes at various stages of the trial lifecycle. These processes often involve complex behaviours such as recruiting vulnerable patient populations and clinicians having to deliver complex trial interventions successfully. Few studies have utilised a behavioural framework to assess challenges and develop strategies for effective trial recruitment and delivery of trial interventions. This study reports the application of an innovative methodological approach to understand core trial processes, namely recruitment and intervention delivery, using a behavioural science approach to develop strategies designed to mitigate trial process problems. METHODS: The UK-REBOA trial aims to evaluate the clinical and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (a novel intervention) in injured patients with exsanguinating haemorrhage. A behavioural investigation ('diagnosis') was conducted using theory-informed (Theoretical Domains Framework, TDF) semi-structured interviews with site staff from the UK-REBOA trial to examine trial processes which could be improved in relation to trial recruitment and delivery of the intervention. Interviews were analysed using the TDF to identify influences on behaviour, which were then mapped to techniques for behaviour change and developed into potential solutions. RESULTS: The behavioural diagnosis of the challenges experienced during trial processes highlighted factors relevant to a range of TDF domains: Skills, Environmental context and resources, Beliefs about capabilities, Beliefs about consequences, Social influences, and Memory, attention, and decision-making processes. Within the solution development phase, we identified 24 suitable behaviour change techniques that were developed into proposed solutions to target reported process problems with the aim of changing behaviour to improve recruitment and/or intervention delivery. Proposed solutions included targeted changes to trial training content, suggestions to restructure the environment (e.g. reinforced the purpose of the trial with information about the social and environmental consequences) and other strategies to reduce barriers to recruitment and intervention delivery. CONCLUSIONS: This study demonstrates the feasibility of applying a behavioural approach to investigate ('diagnose') behavioural trial process problems and subsequently develop and implement targeted solutions ('treatment') in an active trauma trial. Understanding the factors that affected behaviour, attitudes and beliefs in this trauma trial allowed us to implement theoretically informed, evidence-based solutions designed to enhance trial practices. TRIAL REGISTRATION: ISRCTN 16,184,981.

Behavioural approaches to recruitment and retention in clinical trials: a systematic mapping review.

OBJECTIVES: To identify studies that applied behavioural approaches to issues of recruitment and/or retention to trials; to describe these approaches; and to identify gaps for future research. DESIGN: Systematic mapping review of research undertaken in clinical trials within peer-reviewed sources. Review participants were individuals involved in clinical trials, including trial staff, participants, potential participants and former participants. DATA SOURCES: MEDLINE, EMBASE, CINAHL, ERIC, PsycINFO, Web of Science and ASSIA from inception to 15 January 2020 with no date or language restrictions. ELIGIBILITY CRITERIA: Studies within the context of clinical trials reporting the barriers/facilitators to recruitment and retention, or developing/evaluating solutions to said barriers/facilitators, using a behavioural approach. RESULTS: 31 articles were included. Recruitment-focused studies (n=22, 71%) represented the majority. Studies tended to focus on participant behaviours (n=22, 71%). Underserved populations (n=11, 35%) were a notable subset of studies. Most studies (n=23, 74%) were exploratory but those that evaluated interventions (n=8, 26%) often did so within underserved populations (n=6). A majority of studies (n=30, 97%) did not specify their behaviours consistent with guidelines from behavioural scientists. The most used approaches were social cognitive theory (n=8, 26%), the theory of planned behaviour (n=6, 19%) and the theoretical domains framework (n=5, 16%). CONCLUSIONS: A range of behavioural approaches have been applied to recruitment and retention to trials. The multitude of recruitment research here is consistent with trials research generally and emphasises the need for research into retention. Authors report target behaviours minimally, which is not conducive to replication. Further research should build on lessons here, such as clearly specifying behaviours. Increased methodological rigour and transparency will lead to robust evidence bases and less research waste in poor recruitment and retention. Overall, trials informed by behavioural approaches promises to be efficient and more participant focused.

'You had to do something': prescribing antibiotics in Scotland during the COVID-19 pandemic restrictions and remobilisation.

Introduction The COVID-19 pandemic brought about seismic change for dentistry including the direction to provide remote advice and prescribe analgesia and antimicrobials. The possibilities for care have widened, but the impact of both restrictions and remobilisation on antibiotic prescribing is not known.Aims To report the impact of COVID-19 restrictions and remobilisation on dental antibiotic prescriptions and explore dentists' intentions and attitudes towards antibiotic prescribing.Design and setting Public Health Scotland national prescribing and claims data are reported alongside an online survey of Scottish general and public health service dentists including closed and open-ended questions.Results Antibiotic prescribing rose by 49% following the suspension of routine dental care, to a peak of 34,993 antibiotics (July 2020). The data also show that since the remobilisation of NHS dental care, antibiotic prescribing remains raised at levels around 28% higher than pre-pandemic. The survey highlights dentists' frustrations and concerns about this increased use of antibiotics. Most dentists intend to reduce their prescribing; however, significant challenges to this being realised were raised.Conclusions The previous success within dentistry to protect against the development of antimicrobial resistance has suffered a knock-back during the pandemic. A renewed focus on reducing unnecessary antibiotics within dentistry is required but, crucially, needs to be approached sensitively alongside the current backdrop of challenges within the service.

An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations.

OBJECTIVES: This study investigated trial consultations to identify whether and to what extent discussions of retention are present. STUDY DESIGN AND SETTING: This embedded mixed-methods study design included a purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-based surgical RCT. Study participants included potential trial participants, trial surgeons (TSs), and research nurses (RNs). RESULTS: Forty-four participants were included in this study: potential trial participants (n = 37); TSs (n = 4); and RNs (n = 3). Analysis revealed no discussion of retention across 79% of consultations. Of the remaining 21% where discussions of retention were present, only 3% (maximum) of the conversation related to retention. There was some evidence of good practice, but on the whole the discussions contained inaccuracies about timing and delivery of questionnaires and the right to withdraw often highlighted without providing trial consequences. CONCLUSION: This study is the first to explore trial consultations for discussions of retention. It suggests that there may be room for improvement within current practice. Further research is required to determine the generalizability of the findings reported to other clinical trials.

Pharmacist and Data-Driven Quality Improvement in Primary Care (P-DQIP): a qualitative study of anticipated implementation factors informed by the Theoretical Domains Framework.

OBJECTIVES: The quality and safety of drug therapy in primary care are global concerns. The Pharmacist and Data-Driven Quality Improvement in Primary Care (P-DQIP) intervention aims to improve prescribing safety via an informatics tool, which facilitates proactive management of drug therapy risks (DTRs) by health-board employed pharmacists with established roles in general practices. Study objectives were (1) to identify and prioritise factors that could influence P-DQIP implementation from the perspective of practice pharmacists and (2) to identify potentially effective, acceptable and feasible strategies to support P-DQIP implementation. DESIGN: Semistructured face-to-face interviews using a Theoretical Domains Framework informed topic guide. The framework method was used for data analysis. Identified implementation factors were prioritised for intervention based on research team consensus. Candidate intervention functions, behavioural change techniques (BCTs) and policies targeting these were identified from the behavioural change wheel. The final intervention content and modes of delivery were agreed with local senior pharmacists. SETTING: General practices from three Health and Social Care Partnerships in National Health Service (NHS) Tayside. PARTICIPANTS: 14 NHS employed practice pharmacists. RESULTS: Identified implementation factors were linked to thirteen theoretical domains (all except intentions) and six (skill, memory/attention/decision making, behavioural regulation, reinforcement, environmental context/resources, social influences) were prioritised. Three intervention functions (training, enablement and environmental restructuring) were relevant and were served by two policy categories (guidelines, communication/marketing) and eight BCTs (instructions on how to perform a behaviour, problem solving, action planning, prompt/cues, goal setting, self-monitoring, feedback and restructuring the social environment). Intervention components encompass an informatics tool, written educational material, a workshop for pharmacists, promotional activities and small financial incentives. CONCLUSIONS: This study explored pharmacists' perceptions of implementation factors which could influence management of DTRs in general practices to inform implementation of P-DQIP, which will initially be implemented in one Scottish health board with parallel evaluation of effectiveness and implementation.

Assessing effective interventions to improve trial retention: do they contain behaviour change techniques?

BACKGROUND: Clinical trials often struggle to retain the number of participants required to make valid and reliable assessments about the effectiveness of treatments. Several individual randomised comparisons of interventions to improve retention in trials have been shown to be effective. Many of these retention interventions target participants' behaviour (e.g. returning questionnaires or attending a follow-up visit). Although not designed as such, these interventions can be thought of as behaviour change interventions. By coding the constituent behaviour change components of effective retention interventions, the interventions' potential 'active ingredients' responsible for improvements in retention can be identified and maximised for future gains. METHODS: Studies reporting effective retention interventions were identified from existing meta-analyses in the literature. Published manuscripts and intervention and comparator group material were coded into their behaviour change techniques (BCTs) using the BCT taxonomy version 1. Two authors independently coded materials using a standardised coding manual and discussed any disagreements to reach consensus. Data on study characteristics including host trial context, timing, mode of delivery and dosage of retention intervention were recorded. RESULTS: Two intervention types were identified as having evidence of improving retention in existing meta-analyses: monetary incentives and electronic prompts. None of the interventions identified from the included studies explicitly stated a theoretical rationale for their development. BCTs were identified in both intervention and comparator groups across both intervention types and there was heterogeneity with regard to their presentation within and across interventions. The BCTs identified in the 'monetary incentive' interventions differed to the comparator group. Contrastingly, the BCTs identified in 'electronic prompts' interventions were identical in both the control and intervention groups (within studies) and differed only in terms of mode of delivery and dosing. CONCLUSIONS: Attending a measurement visit or returning a questionnaire is a behaviour and trialists should be mindful of this when designing retention interventions. Our work in this area provides some of the first evidence of the impact of implicit use of BCTs in retention interventions and highlights their potential promise for future trials.

A behavioural approach to specifying interventions: what insights can be gained for the reporting and implementation of interventions to reduce antibiotic use in hospitals?

BACKGROUND: Reducing unnecessary antibiotic exposure is a key strategy in reducing the development and selection of antibiotic-resistant bacteria. Hospital antimicrobial stewardship (AMS) interventions are inherently complex, often requiring multiple healthcare professionals to change multiple behaviours at multiple timepoints along the care pathway. Inaction can arise when roles and responsibilities are unclear. A behavioural perspective can offer insights to maximize the chances of successful implementation. OBJECTIVES: To apply a behavioural framework [the Target Action Context Timing Actors (TACTA) framework] to existing evidence about hospital AMS interventions to specify which key behavioural aspects of interventions are detailed. METHODS: Randomized controlled trials (RCTs) and interrupted time series (ITS) studies with a focus on reducing unnecessary exposure to antibiotics were identified from the most recent Cochrane review of interventions to improve hospital AMS. The TACTA framework was applied to published intervention reports to assess the extent to which key details were reported about what behaviour should be performed, who is responsible for doing it and when, where, how often and with whom it should be performed. RESULTS: The included studies (n = 45; 31 RCTs and 14 ITS studies with 49 outcome measures) reported what should be done, where and to whom. However, key details were missing about who should act (45%) and when (22%). Specification of who should act was missing in 79% of 15 interventions to reduce duration of treatment in continuing-care wards. CONCLUSIONS: The lack of precise specification within AMS interventions limits the generalizability and reproducibility of evidence, hampering efforts to implement AMS interventions in practice.

Barriers and Facilitators to Implementation of Antibiotic Stewardship Programmes in Hospitals in Developed Countries: Insights From Transnational Studies.

Objectives: To identify perceived influences on implementation of antibiotic stewardship programmes (ASPs) in hospitals, across healthcare systems, and to exemplify the use of a behavioral framework to conceptualize those influences. Methods: EMBASE and MEDLINE databases were searched from 01/2001 to 07/2017 and reference lists were screened for transnational studies that reported barriers and/or facilitators to implementing actual or hypothetical ASPs or ASP-supporting strategies. Extracted data were synthesized using content analysis with the Theoretical Domains Framework as an organizing framework. Commonly reported influences were quantified. Results: From 3,196 abstracts 75 full-text articles were screened for inclusion. Eight studies met the eligibility criteria. The number of countries involved in each study ranged from 2 to 36. These studies included a total of 1849 participants. North America, Europe and Australasia had the strongest representation. Participants were members of special interest groups, designated hospital representatives or clinical experts. Ten of the 14 theoretical domains in the framework were present in the results reported in the included studies. The most commonly reported (≥4 out of 8 studies) influences on ASP implementation were coded in the domain "environmental context and resources" (e.g., problems with data and information systems; lack of key personnel; inadequate financial resources) and "goals" (other higher priorities). Conclusions: Despite an extensive transnational research effort, there is evidence from international studies of substantial barriers to implementing ASPs in hospitals, even in developed countries. Large-scale efforts to implement hospital antibiotic stewardship in those countries will need to overcome issues around inadequacy of information systems, unavailability of key personnel and funding, and the competition from other priority initiatives. We have enhanced the evidence base to inform guidance by taking a behavioral approach to identify influences on ASP uptake. Systematic review registration: PROSPERO registration number CRD42017076425.

Qualitative study exploring the key determinants of information gathering to inform the management of over-the-counter (OTC) consultations in community pharmacies.

OBJECTIVES: Gathering relevant patient information during over-the-counter (OTC) consultations increases the likelihood of safe, effective and person-centred outcomes. The aim of this study was to explore the key determinants to information gathering during consultations for non-prescription medicine requests in community pharmacies in Scotland. DESIGN: Semi-structured interviews using the Theoretical Domains Framework (TDF), with community pharmacy teams across Scotland. Interviews explored participants' knowledge of current guidance, skills required to elicit information and barriers and facilitators associated with this behaviour. Theory-based content analysis was undertaken using the TDF as an initial coding framework to identify key determinants and map them to salient domains. Salience was determined by prominence or variation in views. Comparative analysis was undertaken by professional role. RESULTS: Thirty interviews were conducted with pharmacists (n=19) and medicine counter assistants (MCAs) (n=11). Eight salient domains were identified: environmental context and resources (privacy), beliefs about consequences (patient safety), skills (communication, decision-making), social influences (patient awareness of pharmacist role), knowledge (awareness and use of standard operating procedures), social professional role and identity (perception of own role), behavioural regulation (training) and intention (to gather information). Similar domains were salient for pharmacists and MCAs; however, different beliefs were associated with different roles. Overarching themes were identified: best practice, health literacy, decision-making and professionalism. CONCLUSIONS: Multiple influences and complexities affect the effective management of OTC consultations. While similar factors impact on both pharmacists and MCAs at a patient, professional and environmental level, subtle differences exist in how these influence their management of OTC consultations. This study highlights the importance of tailoring interventions to reflect different roles, functions and responsibilities of community pharmacy personnel.

Areas for improvement in community optometry: flashes and floaters take priority.

PURPOSE: A common response to rising demand for healthcare is to extend the role of health professionals and the range of their service provision. Community optometry in Scotland is a recent example of this. Within this context of innovation and change there are challenges to ensuring quality in optometry practice. The purpose of this research is to establish what the priorities are for practice improvement within community optometry and to start a programme to inform strategies to improve practice. METHODS: A four stage study was conducted: (1) a service-driven topic prioritisation exercise to identify priorities for optometry practice improvement; (2) a review of national and international guidance and UK protocols relating to the identified priority topic; (3) a national theory-based survey identifying current practice and the barriers and facilitators to the target behaviour; and (4) the identification of theory-based intervention options to improve practice. The Behaviour Change Wheel approach to behaviour change intervention development and Theoretical Domains Framework (TDF) provided the underlying theoretical framework. RESULTS: Stakeholders identified 'patients presenting with flashes and floaters' as an important priority for practice improvement. The decision about whether or not to refer patients on to secondary care for further examination is the target behaviour. Guidance for optometrists on this topic is lacking. Six TDF domains were related to the decision about whether or not to refer patients with flashes and floaters to secondary care - 'social influences', 'emotion', 'beliefs about capabilities', 'beliefs about consequences', 'behavioural regulation' and 'reinforcement'. CONCLUSIONS: This study has examined current practice in relation to the management of patients with flashes and floaters, identified the most salient targets for future strategies to improve optometry practice and highlighted what form these strategies may take. It demonstrates the use of a flexible, theory-informed approach, which can be used to engage with stakeholders and professionals to inform the design and development of efforts to improve practice in a variety of healthcare settings.

A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems.

BACKGROUND: Implementing new practices requires changes in the behaviour of relevant actors, and this is facilitated by understanding of the determinants of current and desired behaviours. The Theoretical Domains Framework (TDF) was developed by a collaboration of behavioural scientists and implementation researchers who identified theories relevant to implementation and grouped constructs from these theories into domains. The collaboration aimed to provide a comprehensive, theory-informed approach to identify determinants of behaviour. The first version was published in 2005, and a subsequent version following a validation exercise was published in 2012. This guide offers practical guidance for those who wish to apply the TDF to assess implementation problems and support intervention design. It presents a brief rationale for using a theoretical approach to investigate and address implementation problems, summarises the TDF and its development, and describes how to apply the TDF to achieve implementation objectives. Examples from the implementation research literature are presented to illustrate relevant methods and practical considerations. METHODS: Researchers from Canada, the UK and Australia attended a 3-day meeting in December 2012 to build an international collaboration among researchers and decision-makers interested in the advancing use of the TDF. The participants were experienced in using the TDF to assess implementation problems, design interventions, and/or understand change processes. This guide is an output of the meeting and also draws on the authors' collective experience. Examples from the implementation research literature judged by authors to be representative of specific applications of the TDF are included in this guide. RESULTS: We explain and illustrate methods, with a focus on qualitative approaches, for selecting and specifying target behaviours key to implementation, selecting the study design, deciding the sampling strategy, developing study materials, collecting and analysing data, and reporting findings of TDF-based studies. Areas for development include methods for triangulating data, e.g. from interviews, questionnaires and observation and methods for designing interventions based on TDF-based problem analysis. CONCLUSIONS: We offer this guide to the implementation community to assist in the application of the TDF to achieve implementation objectives. Benefits of using the TDF include the provision of a theoretical basis for implementation studies, good coverage of potential reasons for slow diffusion of evidence into practice and a method for progressing from theory-based investigation to intervention.

An Audit and Feedback Intervention for Reducing Antibiotic Prescribing in General Dental Practice: The RAPiD Cluster Randomised Controlled Trial.

BACKGROUND: Dentists prescribe approximately 10% of antibiotics dispensed in UK community pharmacies. Despite clear clinical guidance, dentists often prescribe antibiotics inappropriately. This cluster-randomised controlled trial used routinely collected National Health Service (NHS) dental prescribing and treatment claim data to compare the impact of individualised audit and feedback (A&F) interventions on dentists' antibiotic prescribing rates. METHODS AND FINDINGS: All 795 antibiotic prescribing NHS general dental practices in Scotland were included. Practices were randomised to the control (practices = 163; dentists = 567) or A&F intervention group (practices = 632; dentists = 1,999). A&F intervention practices were allocated to one of two A&F groups: (1) individualised graphical A&F comprising a line graph plotting an individual dentist's monthly antibiotic prescribing rate (practices = 316; dentists = 1,001); or (2) individualised graphical A&F plus a written behaviour change message synthesising and reiterating national guidance recommendations for dental antibiotic prescribing (practices = 316; dentists = 998). Intervention practices were also simultaneously randomised to receive A&F: (i) with or without a health board comparator comprising the addition of a line to the graphical A&F plotting the monthly antibiotic prescribing rate of all dentists in the health board; and (ii) delivered at 0 and 6 mo or at 0, 6, and 9 mo, giving a total of eight intervention groups. The primary outcome, measured by the trial statistician who was blinded to allocation, was the total number of antibiotic items dispensed per 100 NHS treatment claims over the 12 mo post-delivery of the baseline A&F. Primary outcome data was available for 152 control practices (dentists = 438) and 609 intervention practices (dentists = 1,550). At baseline, the number of antibiotic items prescribed per 100 NHS treatment claims was 8.3 in the control group and 8.5 in the intervention group. At follow-up, antibiotic prescribing had decreased by 0.4 antibiotic items per 100 NHS treatment claims in control practices and by 1.0 in intervention practices. This represents a significant reduction (-5.7%; 95% CI -10.2% to -1.1%; p = 0.01) in dentists' prescribing rate in the intervention group relative to the control group. Intervention subgroup analyses found a 6.1% reduction in the antibiotic prescribing rate of dentists who had received the written behaviour change message relative to dentists who had not (95% CI -10.4% to -1.9%; p = 0.01). There was no significant between-group difference in the prescribing rate of dentists who received a health board comparator relative to those who did not (-4.3%; 95% CI -8.6% to 0.1%; p = 0.06), nor between dentists who received A&F at 0 and 6 mo relative to those who received A&F at 0, 6, and 9 mo (0.02%; 95% CI -4.2% to 4.2%; p = 0.99). The key limitations relate to the use of routinely collected datasets which did not allow evaluation of any effects on inappropriate prescribing. CONCLUSIONS: A&F derived from routinely collected datasets led to a significant reduction in the antibiotic prescribing rate of dentists. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49204710.

Barriers and facilitators of evidence-based management of patients with bacterial infections among general dental practitioners: a theory-informed interview study.

BACKGROUND: General dental practitioners (GDPs) regularly prescribe antibiotics to manage dental infections although most infections can be treated successfully by local measures. Published guidance to support GDPs to make appropriate prescribing decisions exists but there continues to be wide variation in dental antibiotic prescribing. An interview study was conducted as part of the Reducing Antibiotic Prescribing in Dentistry (RAPiD) trial to understand the barriers and facilitators of using local measures instead of prescribing antibiotics to manage bacterial infections. METHODS: Thirty semi-structured one-to-one telephone interviews were conducted using the Theoretical Domains Framework (TDF). Responses were coded into domains of the TDF and sub-themes. Priority domains (high frequency: ≥50 % interviewees discussed) relevant to behaviour change were identified as targets for future intervention efforts and mapped onto 'intervention functions' of the Behaviour Change Wheel system. RESULTS: Five domains (behavioural regulation, social influences, reinforcement, environmental context and resources, and beliefs about consequences) with seven sub-themes were identified as targets for future intervention. All participants had knowledge about the evidence-based management of bacterial infections, but they reported difficulties in following this due to patient factors and time management. Lack of time was found to significantly influence their decision processes with regard to performing local measures. Beliefs about their capabilities to overcome patient influence, beliefs that performing local measures would impact on subsequent appointment times as well as there being no incentives for performing local measures were also featured. Though no knowledge or basic skills issues were identified, the participants suggested some continuous professional development programmes (e.g. time management, an overview of published guidance) to address some of the barriers. The domain results suggest a number of intervention functions through which future interventions could change GDPs' antibiotic prescribing for bacterial infections: imparting skills through training, providing an example for GDPs to imitate (i.e. modelling) or creating the expectation of a reward (i.e. incentivisation). CONCLUSIONS: This is the first theoretically informed study to identify barriers and facilitators of evidence-based management of patients with bacterial infections among GDPs. A pragmatic approach is needed to address the modifiable barriers in future interventions intended to change dentists' inappropriate prescribing behaviour.

Selective decontamination of the digestive tract in critically ill patients treated in intensive care units: a mixed-methods feasibility study (the SuDDICU study).

BACKGROUND: Hospital-acquired infections (HAIs) are a major cause of morbidity and mortality. Critically ill patients in intensive care units (ICUs) are particularly susceptible to these infections. One intervention that has gained much attention in reducing HAIs is selective decontamination of the digestive tract (SDD). SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of intravenous (i.v.) antibiotics. SDD may reduce infections and improve mortality, but has not been widely adopted in the UK or internationally. Hence, there is a need to identify the reasons for low uptake and whether or not further clinical research is needed before wider implementation would be considered appropriate. OBJECTIVES: The project objectives were to (1) identify and describe the SDD intervention, (2) identify views about the evidence base, (3) identify acceptability of further research and (4) identify feasibility of further randomised controlled trials (RCTs). DESIGN: A four-stage approach involving (1) case studies of two ICUs in which SDD is delivered including observations, interviews and documentary analysis, (2) a three-round Delphi study for in-depth investigation of clinicians' views, including semi-structured interviews and two iterations of questionnaires with structured feedback, (3) a nationwide online survey of consultants in intensive care medicine and clinical microbiology and (4) semistructured interviews with international clinical triallists to identify the feasibility of further research. SETTING: Case studies were set in two UK ICUs. Other stages of this research were conducted by telephone and online with NHS staff working in ICUs. PARTICIPANTS: (1) Staff involved in SDD adoption or delivery in two UK ICUs, (2) ICU experts (intensive care consultants, clinical microbiologists, hospital pharmacists and ICU clinical leads), (3) all intensive care consultants and clinical microbiologists in the UK with responsibility for patients in ICUs were invited and (4) international triallists, selected from their research profiles in intensive care, clinical trials and/or implementation trials. INTERVENTIONS: SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of i.v. antibiotics. MAIN OUTCOME MEASURES: Levels of support for, or opposition to, SDD in UK ICUs; views about the SDD evidence base and about barriers to implementation; and feasibility of further SDD research (e.g. likely participation rates). RESULTS: (1) The two case studies identified complexity in the interplay of clinical and behavioural components of SDD, involving multiple staff. However, from the perspective of individual staff, delivery of SDD was regarded as simple and straightforward. (2) The Delphi study (n = 42) identified (a) specific barriers to SDD implementation, (b) uncertainty about the evidence base and (c) bimodal distributions for key variables, e.g. support for, or opposition to, SDD. (3) The national survey (n = 468) identified uncertainty about the effect of SDD on antimicrobial resistance, infection rates, mortality and cost-effectiveness. Most participants would participate in further SDD research. (4) The triallist interviews (n = 10) focused largely on the substantial challenges of conducting a large, multinational clinical effectiveness trial. CONCLUSIONS: There was considerable uncertainty about possible benefits and harms of SDD. Further large-scale clinical effectiveness trials of SDD in ICUs may be required to address these uncertainties, especially relating to antimicrobial resistance. There was a general willingness to participate in a future effectiveness RCT of SDD. However, support was not unanimous. Future research should address the barriers to acceptance and participation in any trial. There was some, but a low level of, interest in adoption of SDD, or studies to encourage implementation of SDD into practice. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 25. See the NIHR Journals Library website for further project information.

The views of health care professionals about selective decontamination of the digestive tract: an international, theoretically informed interview study.

PURPOSE: Selective decontamination of the digestive tract (SDD) as a prophylactic intervention improves hospital-acquired infection and survival rates. Uptake of SDD is low and remains controversial. This study applied the theoretical domains framework to assess intensive care unit clinicians' views about SDD in regions with limited or no adoption of SDD. MATERIALS AND METHODS: Participants were health professionals with "decisional authority" for the adoption of SDD. Semistructured interviews were conducted as the first round of a Delphi study. Views about SDD adoption, delivery, and further SDD research were explored. Directed content analysis of interview data identified subthemes, which informed item development for subsequent Delphi rounds. Linguistic features of interview data were also explored. RESULTS: One hundred forty-one participants provided interview data. Fifty-six subthemes were identified; 46 were common across regions. Beliefs about consequences were the most widely elaborated theme. Linguistic features of how participants discussed SDD included caution expressed when discussing the risks and benefits and words such as "worry," "anxiety," and "fear" when discussing potential antibiotic resistance associated with SDD. CONCLUSIONS: We identified salient beliefs, barriers, and facilitators to SDD adoption and delivery. What participants said about SDD and the way in which they said it demonstrated the degree of clinical caution, uncertainty, and concern that SDD evokes.