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The Royal College of General Practitioners has launched an Accredited Professional Development (APD) programme to prepare GPs for revalidation. This paper describes an evaluation of the APD pilot programme run within the Kent, Surrey and Sussex GP Deanery area. Interviews were undertaken with a sample of 20 participants to identify their views on the feasibility, acceptability and practicability of the programme.APD is based on a facilitated, distance-learning approach using a structured pro-gramme targeted at the areas described in the RCGP document Good Medical Practice for General Practitioners. l The research demonstrates that GPs are extremely supportive of the programme, valuing the flexible, learner-centred style of the teaching and learning. However, it is recognised that such an approach may not suit traditional learners. Participants were very positive about the structure of APD and the quality of its learning materials, but indicated that the role of the facilitator was crucial to its success. Facilitators were concerned about the time involvement of their role and indicated that without proper funding it would be unsustainable. [ABSTRACT FROM AUTHOR]

Background/aim: The objective of this study was to describe current surveillance platforms which support routine quality measurement in paediatric critical care., Method: Scoping review. The search strategy consisted of a traditional database and grey literature search as well as expert consultation. Surveillance platforms were eligible for inclusion if they collected measures of quality in critically ill children., Results: The search strategy identified 21 surveillance platforms, collecting 57 unique outcome (70%), process (23%), and structural (7%) quality measures. Hospital-associated infections were the most commonly collected outcome measure across all platforms (n = 11; 52%). In general, case definitions were not harmonised across platforms, with the exception of nationally mandated hospital-associated infections (e.g., central line-associated blood stream infection). Data collection relied on manual coding. Platforms typically did not provide an evidence-based rationale for measures collected, with no identifiable reports of co-designed, consensus-derived measures or consumer involvement in measure selection or prioritisation., Conclusions: Quality measurement in critically ill children lacks uniformity in definition which limits local and international benchmarking. Current surveillance activities for critically ill children focus heavily on outcome measurement, with process, structural, and patient-reported measures largely overlooked. Long-term outcome measures were not routinely collected. Harmonisation of paediatric intensive care unit quality measures is needed and can be achieved using prioritisation and consensus/co-design methods., (Copyright © 2022 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.)

Background: Peripheral intravenous catheters (PIVCs) are the most used invasive medical device in healthcare. Yet around half of insertion attempts are unsuccessful leading to delayed medical treatments and patient discomfort of harm. Ultrasound-guided PIVC (USGPIVC) insertion is an evidence-based intervention shown to improve insertion success especially in patients with Difficult IntraVenous Access (BMC Health Serv Res 22:220, 2022), however the implementation in some healthcare settings remains suboptimal. This study aims to co-design interventions that optimise ultrasound guided PIVC insertion in patients with DIVA, implement and evaluate these initiatives and develop scale up activities., Methods: A stepped-wedge cluster randomized controlled trial will be conducted in three hospitals (two adult, one paediatric) in Queensland, Australia. The intervention will be rolled out across 12 distinct clusters (four per hospital). Intervention development will be guided by Michie's Behavior Change Wheel with the aim to increase local staff capability, opportunity, and motivation for appropriate, sustainable adoption of USGPIVC insertion. Eligible clusters include all wards or departments where > 10 PIVCs/week are typically inserted. All clusters will commence in the control (baseline) phase, then, one cluster per hospital will step up every two months, as feasible, to the implementation phase, where the intervention will be rolled out. Implementation strategies are tailored for each hospital by local investigators and advisory groups, through context assessments, staff surveys, and stakeholder interviews and informed by extensive consumer interviews and consultation. Outcome measures align with the RE-AIM framework including clinical-effectiveness outcomes (e.g., first-time PIVC insertion success for DIVA patients [primary outcome], number of insertion attempts); implementation outcomes (e.g., intervention fidelity, readiness assessment) and cost effectiveness outcomes. The Consolidated Framework for Implementation Research framework will be used to report the intervention as it was implemented; how people participated in and responded to the intervention; contextual influences and how the theory underpinning the intervention was realised and delivered at each site. A sustainability assessment will be undertaken at three- and six-months post intervention., Discussion: Study findings will help define systematic solutions to implement DIVA identification and escalation tools aiming to address consumer dissatisfaction with current PIVC insertion practices. Such actionable knowledge is critical for implementation of scale-up activities., Trial Registration: Prospectively registered (Australian and New Zealand Clinical Trials Registry; ACTRN12621001497897)., (© 2023. Crown.)

Objective: The objective of this study was to audit current patient blood management practice in children throughout cardiac surgery and paediatric intensive care unit (PICU) admission., Design: This was a prospective observational cohort study., Setting: This was a single-centre study in the cardiac operating room (OR) and PICU in a major tertiary children's hospital in Australia., Patients: Children undergoing corrective cardiac surgery and requiring admission to PICU for postoperative recovery were included in the study., Measurements and Main Results: Fifty-six patients and 1779 blood sampling episodes were audited over a 7-month period. The median age was 9 months (interquartile range [IQR] = 1-102), with the majority (n = 30 [54%]) younger than 12 months. The median number of blood sampling episodes per patient per day was 6.6 (IQR = 5.8-8.0) in total, with a median of 5.0 (IQR = 4.0-7.5) episodes in the OR and 5.0 (IQR = 3.4-6.2) episodes per day throughout PICU admission. The most common reason for blood tests across both OR and PICU settings was arterial blood gas analysis (total median = 86%, IQR = 79-96). The overall median blood sampling volume per kg of bodyweight, patient, and day was 0.63 mL (IQR = 0.20-1.14) in total. Median blood loss for each patient was 3.5 mL/kg per patient per day (IQR = 1.7-5.6) with negligible amounts in the OR and a median of 3.6 mL/kg (IQR = 1.7-5.7) in the PICU. The median Cell Saver® transfusion volume was 9.9 mL/kg per patient per day (IQR = 4.0-19.1) in the OR. The overall median volume of other infusion products (albumin 4%, albumin 20%, packed red blood cells) received by each patient was 20.1 mL/kg (IQR = 10.7-36.4) per day. Sampling events and blood loss were positively associated with PICU stay., Conclusions: Patient blood management practices observed in this study largely conform to National Blood Authority guidelines. Further implementation projects and research are needed to accelerate implementation of known effective blood conservation strategies within paediatric critical care environments., (Crown Copyright © 2022. Published by Elsevier Ltd. All rights reserved.)

Objective: To develop and validate a difficult intravenous access risk assessment and escalation pathway, to increase first time intravenous insertion success in paediatrics., Methods: Mixed methods underpinned by literature and co-production principles. Iterative development of the instrument was informed through semi-structured interviews and stakeholder workshops. The instrument includes a risk assessment, inserter skill self-assessment, and escalation pathways. Reproducibility, reliability, and acceptability were evaluated in a prospective cohort study at a quaternary paediatric hospital in Australia., Results: Interview data (three parents, nine clinicians) uncovered two themes: i) Recognition of children with DIVA and subsequent escalation is ad hoc and problematic; and ii) Resources and training impact inserter confidence and ability. Three workshops were delivered at monthly intervals (February-April 2020) involving 21 stakeholders culminating in the co-production of the "DIVA Key". The DIVA Key was evaluated between May-December 2020 in 78 children; 156 clinicians. Seventy-eight paired assessments were undertaken with substantial agreement (concordance range = 81.5 to 83.0%) between the assessors. Interrater reliability of the DIVA risk assessment was moderate (kappa = 0.71, 95% CI 0.63-0.80). The DIVA Key predicted multiple insertion attempts for red (high risk) DIVA classification (relative risk ratio 5.7, 95% CI 1.2-27.1; reference low risk). Consumer and clinician satisfaction with DIVA Key was high (median (IQR) = 10 [8-10]; 8 [8-10 respectively)., Conclusion: The DIVA Key is a straightforward, reliable instrument with inbuilt escalation pathway to support the identification of children with difficult intravenous access., (© 2022. The Author(s).)

Background: The optimal intravenous device for antibiotic administration for children with respiratory disease is uncertain. We assessed the feasibility of a randomized controlled trial comparing midline catheters with peripherally inserted central catheters., Methods: Prospective, two-arm, feasibility randomized controlled trial in an Australian tertiary, pediatric hospital. Random assignment of 110 children (<18 years) to receive (i) midline catheter and (ii) peripherally inserted central catheters. Primary outcome was feasibility (eligibility, recruitment, retention, protocol adherence, and acceptability), and the primary clinical outcome was general anesthesia requirement for intravenous catheter insertion., Secondary Outcomes: insertion time, treatment delays, infusion efficiency, device failure, complications, and cost., Results: There was 80% recruitment, 100% retention, no missing data, and high patient/staff acceptability. Mean patient experience assessed on a 0-10 numeric rating scale was 8.0 peripherally inserted central catheters and 9.0 (midline catheters), respectively. Participant eligibility was not achieved (49% of screened patients) and moderate protocol-adherence across groups (89% peripherally inserted central catheters vs. 76% midline catheter). Insertion of midline catheter for pulmonary optimization reduced the requirement for general anesthesia compared to peripherally inserted central catheters (10% vs. 69%; odds ratio = 0.01, 95% confidence interval: 0.00-0.09). Midline catheters failed more frequently (18.1 vs. 5.5 peripherally inserted central catheters per 1000 catheter-days); however, this reduced over trial duration. Midline catheter insertion compared to peripherally inserted central catheters saved AUD$1451 per pulmonary optimization episode., Conclusions: An efficacy trial is feasible with expanded eligibility criteria and intensive staff training when introducing a new device. Midline catheter for peripherally compatible infusions is acceptable to patients and staff, might negate the need for general anesthesia and results in significant cost savings., (© 2021 John Wiley & Sons Ltd.)

Introduction: Peripheral arterial catheters (PAC) are used for haemodynamic monitoring and blood sampling in paediatric critical care. Limited data are available regarding PAC insertion and management practices, and how they relate to device function and failure. This information is necessary to inform future interventional research., Objectives: The primary objective of this study was to describe PAC insertion and management practices, and associated complications. Secondary objectives were to determine patient and clinical characteristics associated with risk of PAC successful insertion and failure., Methods: A prospective, observational study was conducted in the anaesthetic department and paediatric intensive care unit of a tertiary paediatric facility. Data were collected on PAC insertion, PAC management and PAC removal. Standard incidence and prevalence were calculated per 1,000 device days. Risk factors for multiple insertions and PAC failure were identified using Cox regression., Results: A total of 100 catheters in 89 children were examined capturing 472 device days. PACs were primarily inserted for blood sampling (78%) in the radial artery (78%) using ultrasound guidance (67%), with 31% inserted on first attempt. Heparin saline solution was used in 82% of devices. Median catheter dwell was 50.6 hours (IQR 24.0 - 158.0), with PAC failure occurring in 19 devices (20%), at a rate of 40.2 per 1000 catheter days (95% CI 25.7 - 63.1). Arm board immobilisation (HR 2.9; 95% CI 1.02-8.02; p = 0.05), higher PIM3 score (HR 1.06; 95% CI 1.03-1.09; p < 0.01) was associated with an increased the risk of PAC failure, and non-2% chlorhexidine antisepsis was associated with a decrease in PAC failure (HR 0.32; 95% CI 0.11-0.96; p = 0.04), in univariate analysis., Conclusions: PAC insertion is challenging, and failure is common. Prospective clinical trial data is needed to identify high risk patient groups and to develop interventions which optimise practices, thereby reducing failure., (Copyright © 2019 Australian College of Critical Care Nurses Ltd. All rights reserved.)

Hyperspectral imaging for agricultural applications provides a solution for non-destructive, large-area crop monitoring. However, current products are bulky and expensive due to complicated optics and electronics. A linear variable filter was developed for implementation into a prototype hyperspectral imaging camera that demonstrates good spectral performance between 450 and 900 nm. Equipped with a feature extraction and classification algorithm, the proposed system can be used to determine potato plant health with ∼88 % accuracy. This algorithm was also capable of species identification and is demonstrated as being capable of differentiating between rocket, lettuce, and spinach. Results are promising for an entry-level, low-cost hyperspectral imaging solution for agriculture applications.

Spatial interactions between cancer and immune cells, as well as the recognition of tumour antigens by cells of the immune system, play a key role in the immune response against solid tumours. The existing mathematical models generally focus only on one of these key aspects. We present here a spatial stochastic individual-based model that explicitly captures antigen expression and recognition. In our model, each cancer cell is characterised by an antigen profile which can change over time due to either epimutations or mutations. The immune response against the cancer cells is initiated by the dendritic cells that recognise the tumour antigens and present them to the cytotoxic T cells. Consequently, T cells become activated against the tumour cells expressing such antigens. Moreover, the differences in movement between inactive and active immune cells are explicitly taken into account by the model. Computational simulations of our model clarify the conditions for the emergence of tumour clearance, dormancy or escape, and allow us to assess the impact of antigenic heterogeneity of cancer cells on the efficacy of immune action. Ultimately, our results highlight the complex interplay between spatial interactions and adaptive mechanisms that underpins the immune response against solid tumours, and suggest how this may be exploited to further develop cancer immunotherapies., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objectives: Central venous access devices enable many treatments during critical illness; however, 25% of pediatric central venous access devices fail before completion of treatment due to infection, thrombosis, dislodgement, and occlusion. This is frequently attributed to inadequate securement and dressing of the device; however, high-quality research evaluating pediatric central venous access device securement innovation to prevent central venous access device failure is scarce. This study aimed to establish the feasibility of a definitive randomized control trial examining the effectiveness of current and new technologies to secure central venous access devices in pediatrics., Design: Single-center, parallel group, superiority, pilot randomized control trial., Setting: Anesthetic and intensive care departments of a tertiary pediatric hospital SUBJECTS:: One-hundred eighty pediatric patients with nontunneled central venous access device INTERVENTIONS:: Participants were randomized to receive central venous access device securement via standard care (bordered polyurethane dressing, with prolene sutures, chlorhexidine gluconate disc), tissue adhesive (Histoacryl, B Braun, Melsungen, Germany) in addition to standard care; or integrated dressing securement (SorbaView SHIELD [Centurion Medical Products, Franklin, MA], with prolene sutures and chlorhexidine gluconate disc)., Outcomes: Primary: Feasibility (including effect size estimates, acceptability); central venous access device failure; central venous access device complications; secondary: individual central venous access device complications, skin damage, dressing performance, and product cost., Measurements and Main Results: Feasibility criteria were achieved as recruitment occurred with acceptable eligibility, recruitment, missing data, and attrition rates, as well as good protocol adherence. Family members and staff-reported comparable levels of acceptability between study arms; however, tissue adhesive was reported as the most difficult to apply. Overall, 6% of central venous access devices failed, including 6% (3/54; incident rate, 13.2 per 1,000 catheter days) standard care, 2% (1/56; incident rate, 3.65 per 1,000 catheter days) integrated, and 8% (5/59; 25.0 per 1,000 catheter days) tissue adhesive., Conclusions: It is feasible to conduct an efficacy randomized control trial of the studied interventions. Further research is required to definitively identify clinical, cost-effective methods to prevent central venous access device failure by examining new dressing and securement technologies and techniques.

Background: Peripheral venous cannulation is considered a routine procedure, yet 50% of first attempt insertions fail, necessitating repeat insertion attempts. Identification of children with difficult intravenous access (DIVA) can help promote prompt escalation to an appropriately skilled clinician., Objective: To describe current international practice regarding the identification and management of children with DIVA, and to systematically review clinical tools and clinical pathways for children with DIVA., Methods: A cross-sectional, international survey; followed by a systematic review and critical appraisal of clinical pathways using the Appraisal of Guidelines for Research Evaluation (AGREE) II checklist., Results: A total of 148 clinicians from eight countries completed the survey. The majority were nurses (n = 92; 62%), practicing as vascular access specialists (n = 27; 18%). Twenty-three respondents (16%) reported using a DIVA tool, of which the DIVA Score was most common (n = 5; 22%). Five clinical pathways were identified from the survey and review. Based on the AGREE II domains, pathways generally scored well for scope and purpose, and for clarity of presentation areas. Information on the rigor of development and editorial independence was infrequently detailed. Based on AGREE II findings, one pathway was recommended for clinical practice, and four were recommended for use with modification., Conclusions: Resources for the identification and escalation of children with DIVA are not standardized or consistently used. Further work is needed to streamline processes for DIVA identification and escalation to the appropriate clinician, with technology-assisted insertion capability. This will enhance patient experiences and reduce harm from multiple insertion attempts., Clinical Relevance: Multiple failed insertion attempts come at great cost to the child, family, and healthcare service. Early identification and management of the child with DIVA can ensure prompt escalation and management, improving the patient and family experience., (© 2019 Sigma Theta Tau International.)

Background: Internationally, there is a lack of comparative vascular access (VA) data for pediatric clinicians and organizations to benchmark outcomes, evaluate quality initiatives, and improve practice. A VA registry is needed to address these knowledge and data capture gaps., Objectives: To determine the range and heterogeneity of VA outcome measures or quality indicators reported in randomized controlled trials (RCTs) and clinical registries, to inform development of a homogeneous, reliable, minimum dataset for a pediatric VA registry., Methods: Scoping review framework. A systematic search for RCTs reporting VA outcomes in pediatrics and neonates was undertaken in the Cochrane library, EMBASE, CINAHL, PubMed, MEDLINE, and EBSCO using a medical subject headings and key words related to VA and pediatrics. We included RCTs of children (0-18 years) reporting any VA outcome. We identified clinical registries reporting VA data in children (0-18) through web-based searches using key words related to VA and clinical or quality registries. Additional registries were identified through peer consultation. The frequency and scope of outcome measures and quality indicators were extracted from trials and registries and evaluated., Results: From 93 RCTs included, 214 different VA measures were reported, reflecting 14 outcome domains. The most commonly reported outcome domains were insertion (44 RCTs; 47%), noninfectious complications (33 RCTs; 35%), and infectious complications (30 RCTs; 32%). Of the 22 registries identified, VA-associated infection was the main quality indicator routinely collected (12 registries; 55%). Outcomes such as mechanical complications and patient-reported outcomes were infrequently collected., Linking Evidence to Action: Vascular access outcomes reported in pediatric and neonatal RCTs are highly heterogeneous. Internationally, clinical registries currently collect minimal VA data with the exception of infection outcomes. A core dataset of reliable, relevant measures to children and clinicians for VA device quality is needed. This will enable a VA registry that facilitates inter-institutional and international benchmarking., (© 2018 Sigma Theta Tau International.)

Objective: To develop a complex intervention for community pharmacy staff to promote uptake of smoking cessation services and to increase quit rates., Design: Following the Medical Research Council framework, we used a mixed-methods approach to develop, pilot and then refine the intervention., Methods: Phase I : We used information from qualitative studies in pharmacies, systematic literature reviews and the Capability, Opportunity, Motivation-Behaviour framework to inform design of the initial version of the intervention. Phase II : We then tested the acceptability of this intervention with smoking cessation advisers and assessed fidelity using actors who visited pharmacies posing as smokers, in a pilot study. Phase III : We reviewed the content and associated theory underpinning our intervention, taking account of the results of the earlier studies and a realist analysis of published literature. We then confirmed a logic model describing the intended operation of the intervention and used this model to refine the intervention and associated materials., Setting: Eight community pharmacies in three inner east London boroughs., Participants: 12 Stop Smoking Advisers., Intervention: Two, 150 min, skills-based training sessions focused on communication and behaviour change skills with between session practice., Results: The pilot study confirmed acceptability of the intervention and showed preliminary evidence of benefit; however, organisational barriers tended to limit effective operation. The pilot data and realist review pointed to additional use of Diffusion of Innovations Theory to seat the intervention in the wider organisational context., Conclusions: We have developed and refined an intervention to promote smoking cessation services in community pharmacies, which we now plan to evaluate in a randomised controlled trial., Trial Registration Number: UKCRN ID 18446, Pilot., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: New models of primary care are needed to address funding and staffing pressures. We addressed the research question "what works for whom in what circumstances in relation to the role of community pharmacies in providing lifestyle interventions to support smoking cessation?", Methods: This is a realist review conducted according to RAMESES standards. We began with a sample of 103 papers included in a quantitative review of community pharmacy intervention trials identified through systematic searching of seven databases. We supplemented this with additional papers: studies that had been excluded from the quantitative review but which provided rigorous and relevant additional data for realist theorising; citation chaining (pursuing reference lists and Google Scholar forward tracking of key papers); the 'search similar citations' function on PubMed. After mapping what research questions had been addressed by these studies and how, we undertook a realist analysis to identify and refine candidate theories about context-mechanism-outcome configurations., Results: Our final sample consisted of 66 papers describing 74 studies (12 systematic reviews, 6 narrative reviews, 18 RCTs, 1 process detail of a RCT, 1 cost-effectiveness study, 12 evaluations of training, 10 surveys, 8 qualitative studies, 2 case studies, 2 business models, 1 development of complex intervention). Most studies had been undertaken in the field of pharmacy practice (pharmacists studying what pharmacists do) and demonstrated the success of pharmacist training in improving confidence, knowledge and (in many but not all studies) patient outcomes. Whilst a few empirical studies had applied psychological theories to account for behaviour change in pharmacists or people attempting to quit, we found no studies that had either developed or tested specific theoretical models to explore how pharmacists' behaviour may be affected by organisational context. Because of the nature of the empirical data, only a provisional realist analysis was possible, consisting of five mechanisms (pharmacist identity, pharmacist capability, pharmacist motivation and clinician confidence and public trust). We offer hypotheses about how these mechanisms might play out differently in different contexts to account for the success, failure or partial success of pharmacy-based smoking cessation efforts., Conclusion: Smoking cessation support from community pharmacists and their staff has been extensively studied, but few policy-relevant conclusions are possible. We recommend that further research should avoid duplicating existing literature on individual behaviour change; seek to study the organisational and system context and how this may shape, enable and constrain pharmacists' extended role; and develop and test theory.

Change efforts in healthcare sometimes have an ambitious, whole-system remit and seek to achieve fundamental changes in norms and organisational culture rather than (or as well as) restructuring the service. Long-term evaluation of such initiatives is rarely undertaken. We report a secondary analysis of data from an evaluation of a profound institutional change effort in London, England, using a mixed-method longitudinal case study design. The service had received £15 million modernisation funding in 2004, covering multiple organisations and sectors and overseen by a bespoke management and governance infrastructure that was dismantled in 2008. In 2010-11, we gathered data (activity statistics, documents, interviews, questionnaires, site visits) and compared these with data from 2003 to 2008. Data analysis was informed by neo-institutional theory, which considers organisational change as resulting from the material-resource environment and three 'institutional pillars' (regulative, normative and cultural-cognitive), enacted and reproduced via the identities, values and activities of human actors. Explaining the long-term fortunes of the different components of the original programme and their continuing adaptation to a changing context required attention to all three of Scott's pillars and to the interplay between macro institutional structures and embedded human agency. The paper illustrates how neo-institutional theory (which is typically used by academics to theorise macro-level changes in institutional structures over time) can also be applied at a more meso level to inform an empirical analysis of how healthcare organisations achieve change and what helps or hinders efforts to sustain those changes., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Context: The long-term sustainability of whole-system change programs is rarely studied, and when it is, it is inevitably undertaken in a shifting context, thereby raising epistemological and methodological questions. This article describes a transferable methodology that was developed to guide the evaluation of a three-year follow-up of a large health care change program in London, which took place during a period of economic turbulence and rapid policy change., Method: Using a mixed-method organizational case study design, we studied three services (stroke, kidney, and sexual health) across primary and secondary care. Each had received £5 million (US$7.8 million) in modernization funding in 2004. In 2010/2011, we gathered data on the services and compared them with data from 2004 to 2008. The new data set contained quantitative statistics (access, process, and outcome metrics), qualitative interviews with staff and patients, documents, and field notes. Our data analysis was informed by two complementary models of sustainability: intervention-focused (guided by the question, What, if anything, of the original program has been sustained?) and system-dynamic (guided by the question, How and why did change unfold as it did in this complex system?)., Findings: Some but not all services introduced in the original transformation effort of 2004-2008 were still running; others had ceased or been altered substantially to accommodate contextual changes (e.g., in case mix, commissioning priorities, or national policies). Key cultural changes (e.g., quality improvement, patient centeredness) largely persisted, and innovative ideas and practices had spread elsewhere. To draw causal links between the original program and current activities and outcomes, it was necessary to weave a narrative thread with multiple intervening influences. In particular, against a background of continuous change in the local health system, the sustainability of the original vision and capacity for quality improvement was strongly influenced by (1) stakeholders' conflicting and changing interpretations of the targeted health need; (2) changes in how the quality cycle was implemented and monitored; and (3) conflicts in stakeholders' values and what each stood to gain or lose., Conclusions: The sustainability of whole-system change embodies a tension between the persistence of past practice and the adaptation to a changing context. Although the intervention-focused question, What has persisted from the original program? (addressed via a conventional logic model), may be appropriate, evaluators should qualify their findings by also considering the system-dynamic question, What has changed, and why? (addressed by producing a meaningful narrative)., (© 2012 Milbank Memorial Fund.)

Objective: no model of self-management education or peer support has yet achieved widespread reach and acceptability with minority ethnic groups. We sought to refine and test a new complex intervention in diabetes education: informal story-sharing groups facilitated by bilingual health advocates., Methods: pilot randomized trial with in-depth process evaluation in a socioeconomically deprived area. 157 people referred for diabetes education were randomized by concealed allocation to an intervention (story-sharing group in their own language) or control ('usual care' self-management education, through an interpreter if necessary) arm. Story-sharing groups were held in five ethnic languages and English (for African Caribbeans), and ran fortnightly for six months. Primary outcome was UKPDS (UK Prospective Diabetes Study) risk score. Secondary outcomes included attendance, HbA1c, well-being and enablement. Process measures included ethnographic observation, and qualitative interviews with staff and patients., Results: some follow-up data were obtained on 87% of participants. There was no significant difference between intervention and control arms in biomedical outcomes. Attendance was 79% in the story-sharing arm and 35% in the control arm (p < 0.0001), and patient enablement scores were significantly higher (8.3 compared to 5.9, p < 0.005). The model was very popular with clinicians, managers and patients, which helped overcome numerous challenges to its successful embedding in a busy public sector diabetes service., Conclusion: people from minority ethnic groups in a socioeconomically deprived area were keen to attend informal story-sharing groups and felt empowered by them, but clinical outcomes were no better than with conventional education. Further research is needed to maximize the potential and evaluate the place of this appealing service model before it is introduced as a part of mainstream diabetes services., (The Royal Society of Medicine Press Ltd 2011.)

Purpose: This paper seeks to describe the exploration of human resource issues in one large-scale program of innovation in healthcare. It is informed by established theories of management in the workplace and a multi-level model of diffusion of innovations., Design/methodology/approach: A realist approach was used based on interviews, ethnographic observation and documentary analysis., Findings: Five main approaches ("theories of change") were adopted to develop and support the workforce: recruiting staff with skills in service transformation; redesigning roles and creating new roles; enhancing workforce planning; linking staff development to service needs; creating opportunities for shared learning and knowledge exchange. Each had differing levels of success., Practical Implications: The paper includes HR implications for the modernisation of a complex service organisation., Originality/value: This is the first time a realist evaluation of a complex health modernisation initiative has been undertaken.

The present study aimed to determine whether pelvic examinations change clinical management of women with asymptomatic chlamydia infection. Records for women with asymptomatic chlamydia who underwent a pelvic examination at a sexual health clinic in Melbourne, Australia (January 2006 to June 2007) were analysed retrospectively. Of 91 cases, 31 (34%) warranted examination; one woman (1%; 95% confidence interval: 0.5%, 6.4%) had muco-purulent cervicitis and mild tenderness, and was treated for possible pelvic inflammatory disease. These data suggest that a pelvic examination will lead to changes in treatment for very few women diagnosed with asymptomatic chlamydia infection.

Objective: To explore what is known about organizational processes that determine whether (and the extent and rate at which) new non-pharmaceutical technologies are adopted and assimilated into routine health care., Methods: Electronic searching of four databases, hand searching of six journals and electronic citation tracking searches of three key research papers. A narrative synthesis was conducted., Results: Ninety-nine empirical studies and seven narrative overviews informed the findings. The majority (62%) of the studies took a deterministic approach (mainly using cross-sectional mailed questionnaires) and typically studied the impact of organizational variables - such as organizational size - on the rate of adoption of technological innovations. The remaining studies were process-based using a single- or multi-case study approach. The organizational processes that determine whether and how technological innovations are adopted and assimilated into routine health care practice are dependent upon the specific innovation concerned, the different actors involved at various points in time, and the particular organizational context in which decisions are made. It is important to see 'adoption' and 'assimilation' as part of an ongoing process rather than discrete events, and as a process that comprises both 'formal' organizational and 'informal' decisions by individual users (the latter often shaped by discussions with their peers and colleagues)., Conclusions: Further process-based studies are needed to provide a clearer evidence base for recommendations on how to facilitate the adoption and assimilation of beneficial new technologies. Three theoretical perspectives could form the basis of such studies and produce practical advice for managers and practitioners.

Background and Aims: Familial benign hypocalciuric hypercalcaemia (FBHH) is a benign autosomal dominantly inherited condition which results in elevated serum calcium and low urinary calcium. This condition is of clinical interest because it can be mistakenly diagnosed as primary hyperparathyroidism (PHP). In most cases FBHH can be shown to be due to a mutation in the calcium sensing receptor (CASR) gene and we aimed to find the causative mutation in three Scottish kindreds with FBHH., Methods: We used a combination of denaturing gradient gel electrophoresis and direct DNA sequencing to detect mutations in the CASR gene., Results: We detected a mutation in the CASR gene in each of the three kindreds. Two different mutations were detected (the same one was present in two kindreds). Neither mutation has been reported previously. All hypercalcaemic individuals from each kindred had the appropriate mutation while all normocalcaemic individuals did not., Conclusion: In the vast majority of kindreds with FBHH which have been reported previously, the CASR mutation responsible is private to that kindred. In three Scottish kindreds we have identified two new mutations.

Context: Large-scale, whole-systems interventions in health care require imaginative approaches to evaluation that go beyond assessing progress against predefined goals and milestones. This project evaluated a major change effort in inner London, funded by a charitable donation of approximately $21 million, which spanned four large health care organizations, covered three services (stroke, kidney, and sexual health), and sought to "modernize" these services with a view to making health care more efficient, effective, and patient centered., Methods: This organizational case study draws on the principles of realist evaluation, a largely qualitative approach that is centrally concerned with testing and refining program theories by exploring the complex and dynamic interaction among context, mechanism, and outcome. This approach used multiple data sources and methods in a pragmatic and reflexive manner to build a picture of the case and follow its fortunes over the three-year study period. The methods included ethnographic observation, semistructured interviews, and scrutiny of documents and other contemporaneous materials. As well as providing ongoing formative feedback to the change teams in specific areas of activity, we undertook a more abstract, interpretive analysis, which explored the context-mechanism-outcome relationship using the guiding question "what works, for whom, under what circumstances?", Findings: In this example of large-scale service transformation, numerous projects and subprojects emerged, fed into one another, and evolved over time. Six broad mechanisms appeared to be driving the efforts of change agents: integrating services across providers, finding and using evidence, involving service users in the modernization effort, supporting self-care, developing the workforce, and extending the range of services. Within each of these mechanisms, different teams chose widely differing approaches and met with differing success. The realist analysis of the fortunes of different subprojects identified aspects of context and mechanism that accounted for observed outcomes (both intended and unintended)., Conclusions: This study was one of the first applications of realist evaluation to a large-scale change effort in health care. Even when an ambitious change program shifts from its original goals and meets unforeseen challenges (indeed, precisely because the program morphs and adapts over time), realist evaluation can draw useful lessons about how particular preconditions make particular outcomes more likely, even though it cannot produce predictive guidance or a simple recipe for success. Noting recent calls by others for the greater use of realist evaluation in health care, this article considers some of the challenges and limitations of this method in the light of this experience and suggests that its use will require some fundamental changes in the worldview of some health services researchers.

Producing literature reviews of complex evidence for policymaking questions is a challenging methodological area. There are several established and emerging approaches to such reviews, but unanswered questions remain, especially around how to begin to make sense of large data sets drawn from heterogeneous sources. Drawing on Kuhn's notion of scientific paradigms, we developed a new method-meta-narrative review-for sorting and interpreting the 1024 sources identified in our exploratory searches. We took as our initial unit of analysis the unfolding 'storyline' of a research tradition over time. We mapped these storylines by using both electronic and manual tracking to trace the influence of seminal theoretical and empirical work on subsequent research within a tradition. We then drew variously on the different storylines to build up a rich picture of our field of study. We identified 13 key meta-narratives from literatures as disparate as rural sociology, clinical epidemiology, marketing and organisational studies. Researchers in different traditions had conceptualised, explained and investigated diffusion of innovations differently and had used different criteria for judging the quality of empirical work. Moreover, they told very different over-arching stories of the progress of their research. Within each tradition, accounts of research depicted human characters emplotted in a story of (in the early stages) pioneering endeavour and (later) systematic puzzle-solving, variously embellished with scientific dramas, surprises and 'twists in the plot'. By first separating out, and then drawing together, these different meta-narratives, we produced a synthesis that embraced the many complexities and ambiguities of 'diffusion of innovations' in an organisational setting. We were able to make sense of seemingly contradictory data by systematically exposing and exploring tensions between research paradigms as set out in their over-arching storylines. In some traditions, scientific revolutions were identifiable in which breakaway researchers had abandoned the prevailing paradigm and introduced a new set of concepts, theories and empirical methods. We concluded that meta-narrative review adds value to the synthesis of heterogeneous bodies of literature, in which different groups of scientists have conceptualised and investigated the 'same' problem in different ways and produced seemingly contradictory findings. Its contribution to the mixed economy of methods for the systematic review of complex evidence should be explored further.

Background: An increasing proportion of research in primary care is locally undertaken in designated research practices. Capacity building to support high quality research at these grass roots is urgently needed and is a government priority. There is little previously published research on the process by which GP practices develop as research organizations or on their specific support needs at organizational level., Methods: Using in-depth qualitative interviews with 28 key informants in 11 research practices across the UK, we explored their historical accounts of the development of research activity. We analysed the data with reference to contemporary theories of organizational development., Results: Participants identified a number of key events and processes, which allowed us to produce a five-phase model of practice development in relation to research activity (creative energy, concrete planning, transformation/differentiation, consolidation and collaboration). Movement between these phases was not linear or continuous, but showed emergent and adaptive properties in which specific triggers and set-backs were often critical., Conclusion: This developmental model challenges previous categorical taxonomies of research practices. It forms a theory-driven framework for providing appropriate support at the grass roots of primary care research, based on the practice's phase of development and the nature of external triggers and potential setbacks. Our findings have important implications for the strategic development of practice-based research in the UK, and could serve as a model for the wider international community.

Background: The capacity and capabilities for undertaking primary care research have increased both within and outside of the UK in recent years. The UK Department of Health aims to facilitate this further by establishing a national network of primary care organizations (PCOs) ready to act as hosts for shared research governance systems. However, it is unclear which models offer the most effective option. In addition, there is confusion over new processes and concern that researchers may be deterred from addressing important questions., Objectives: The research ascertains how PCOs selected as pilot sites have organized research management and governance (RM&G)., Methods: We adopted a case study approach involving interviews with key informants in a purposive sample of eight pilot PCO (RM&G) sites., Results: Motivating factors for PCOs to host RM&G included the possibility of additional resources and more effective use of research to improve service delivery. A range of organizational models were adopted, often reflecting existing strategic alliances. It is envisaged that it will not be effective or cost-effective for many PCOs to make individual arrangements for RM&G, and so models are already developing among groups of PCOs and partner organizations. The extent of partnerships between PCOs varied with concern over critical mass and dilution of expertise in larger groupings. The development and implementation of systems in pilot sites was facilitated by the support of the wider PCO in recognizing research as a valued and integral part of the organization; the effective management of relationships and the establishment of equal partnership arrangements for RM&G, and the effective use of existing R&D infrastructure and expertise., Conclusions: RM&G partnerships vary according to local circumstances. It is likely that groupings will develop in the future with increasing co-terminosity and across wider health organization boundaries, such as Strategic Heath Authorities (in the UK) or primary care research networks. Critical mass of RM&G arrangements is likely to be linked to levels of research activity. There are real concerns over the levels of bureaucracy associated with the implementation of research governance; however, those PCOs that develop as RM&G sites have the opportunity to enrich their organizations and expand clinically relevant R&D. Partnership working within PCOs and with primary care research networks, academic departments or acute trusts, may be the key to success. Those undertaking research within primary care settings outside of the UK can learn important lessons from the UK experience and ensure development of high quality research that informs improvements in patient care.