Length of hysterotomy for fetal spina bifida repair is associated with prematurity risk.

OBJECTIVE: To investigate whether prenatal repair of spina bifida aperta through mini-hysterotomy results in less prematurity, as compared to standard hysterotomy, when adjusting for known prematurity risks. METHODS: We performed a bi-centric, propensity score matched, controlled study, that is, adjusting for factors earlier reported to result in premature delivery or membrane rupture, in consecutive women having prenatal repair either through stapled hysterotomy or sutured mini-hysterotomy (≤3.5 cm). Matches were pairwise compared and cox-regression analysis was performed to define the hazard ratio of delivery <37 weeks. RESULTS: Of 346 meeting the MOMS-criteria, 78 comparable pairs were available for matched-controlled analysis. Mini-hysterotomy patients were younger and had a higher BMI. Mini-hysterotomy was associated with a 1.67-lower risk of delivery <37 weeks (hazard ratio: 0.60; 95% CI: 0.42-0.85; p = 0.004) and 1.72 for delivery <34 + 6 weeks (hazard ratio: 0.58; 95% CI: 0.34-0.97; p = 0.037). The rate of intact uterine scar at birth (mini-hysterotomy: 98.7% vs. hysterotomy: 90.4%; p = 0.070), the rate of reversal of hindbrain herniation within 1 week after surgery (88.9% vs. 97.4%; p = 0.180) and the rate of cerebrospinal fluid leakage (0% vs. 2.7%; p = 0.50) were comparable. CONCLUSION: Prenatal spina bidifa repair through mini-hysterotomy was associated with a later gestational age at delivery and a comparable intact uterus rate without apparent compromise in neuroprotection.

Prospective development study of the Versius Surgical System for use in transoral robotic surgery: an IDEAL stage 1/2a first in human and initial case series experience.

PURPOSE: Transoral robotic surgery is well established in the treatment paradigm of oropharyngeal pathology. The Versius Surgical System (CMR Surgical) is a robotic platform in clinical use in multiple specialities but is currently untested in the head and neck. This study utilises the IDEAL framework of surgical innovation to prospectively evaluate and report a first in human clinical experience and single centre case series of transoral robotic surgery (TORS) with Versius. METHODS: Following IDEAL framework stages 1 and 2a, the study evaluated Versius to perform first in human TORS before transitioning from benign to malignant cases. Iterative adjustments were made to system setup, instrumentation, and technique, recorded in accordance with IDEAL recommendations. Evaluation criteria included successful procedure completion, setup time, operative time, complications, and subjective impressions. Further evaluation of the system to perform four-arm surgery was conducted. RESULTS: 30 TORS procedures were successfully completed (15 benign, 15 malignant) without intraoperative complication or conversion to open surgery. Setup time significantly decreased over the study period. Instrumentation challenges were identified, urging the need for TORS-specific instruments. The study introduced four-arm surgery, showcasing Versius' unique capabilities, although limitations in distal access were observed. CONCLUSIONS: TORS is feasible with the Versius Surgical System. The development of TORS-specific instruments would benefit performance and wider adoption of the system. 4-arm surgery is possible however further evaluation is required. Multicentre evaluation (IDEAL stage 2b) is recommended.

Intraoperative Applications of Artificial Intelligence in Robotic Surgery: A Scoping Review of Current Development Stages and Levels of Autonomy.

OBJECTIVE: A scoping review of the literature was conducted to identify intraoperative artificial intelligence (AI) applications for robotic surgery under development and categorize them by (1) purpose of the applications, (2) level of autonomy, (3) stage of development, and (4) type of measured outcome. BACKGROUND: In robotic surgery, AI-based applications have the potential to disrupt a field so far based on a master-slave paradigm. However, there is no available overview about this technology's current stage of development and level of autonomy. METHODS: MEDLINE and EMBASE were searched between January 1, 2010 and May 21, 2022. Abstract screening, full-text review, and data extraction were performed independently by 2 reviewers. The level of autonomy was defined according to the Yang and colleagues' classification and stage of development according to the Idea, Development, Evaluation, Assessment, and Long-term follow-up framework. RESULTS: One hundred twenty-nine studies were included in the review. Ninety-seven studies (75%) described applications providing Robot Assistance (autonomy level 1), 30 studies (23%) application enabling Task Autonomy (autonomy level 2), and 2 studies (2%) application achieving Conditional autonomy (autonomy level 3). All studies were at Idea, Development, Evaluation, Assessment, and Long-term follow-up stage 0 and no clinical investigations on humans were found. One hundred sixteen (90%) conducted in silico or ex vivo experiments on inorganic material, 9 (7%) ex vivo experiments on organic material, and 4 (3%) performed in vivo experiments in porcine models. CONCLUSIONS: Clinical evaluation of intraoperative AI applications for robotic surgery is still in its infancy and most applications have a low level of autonomy. With increasing levels of autonomy, the evaluation focus seems to shift from AI-specific metrics to process outcomes, although common standards are needed to allow comparison between systems.

Holistic Human-Serving Digitization of Health Care Needs Integrated Automated System-Level Assessment Tools.

Digital health tools, platforms, and artificial intelligence- or machine learning-based clinical decision support systems are increasingly part of health delivery approaches, with an ever-greater degree of system interaction. Critical to the successful deployment of these tools is their functional integration into existing clinical routines and workflows. This depends on system interoperability and on intuitive and safe user interface design. The importance of minimizing emergent workflow stress through human factors research and purposeful design for integration cannot be overstated. Usability of tools in practice is as important as algorithm quality. Regulatory and health technology assessment frameworks recognize the importance of these factors to a certain extent, but their focus remains mainly on the individual product rather than on emergent system and workflow effects. The measurement of performance and user experience has so far been performed in ad hoc, nonstandardized ways by individual actors using their own evaluation approaches. We propose that a standard framework for system-level and holistic evaluation could be built into interacting digital systems to enable systematic and standardized system-wide, multiproduct, postmarket surveillance and technology assessment. Such a system could be made available to developers through regulatory or assessment bodies as an application programming interface and could be a requirement for digital tool certification, just as interoperability is. This would enable health systems and tool developers to collect system-level data directly from real device use cases, enabling the controlled and safe delivery of systematic quality assessment or improvement studies suitable for the complexity and interconnectedness of clinical workflows using developing digital health technologies.

Beyond the RCT: When are Randomized Trials Unnecessary for New Therapeutic Devices, and What Should We Do Instead?

OBJECTIVE: The aim of this study was to develop an evidence-based framework for evaluation of therapeutic devices, based on ethical principles and clinical evidence considerations. SUMMARY BACKGROUND DATA: Nearly all medical products which do not work solely through chemical action are regulated as medical devices. Their huge range of purposes, mechanisms of action and risks pose challenges for regulation. High-profile implantable device failures have fuelled concerns about the level of clinical evidence needed for market approval. Calls for more rigorous evaluation lack clarity about what kind of evaluation is appropriate, and are commonly interpreted as meaning more randomized controlled trials (RCTs). These are valuable where devices are genuinely new and claim to offer measurable therapeutic benefits. Where this is not the case, RCTs may be inappropriate and wasteful. METHODS: Starting with a set of ethical principles and basic precepts of clinical epidemiology, we developed a sequential decision-making algorithm for identifying when an RCT should be performed to evaluate new therapeutic devices, and when other methods, such as observational study designs and registry-based approaches, are acceptable. RESULTS: The algorithm clearly defines a group of devices where an RCT is deemed necessary, and the associated framework indicates that an IDEAL 2b study should be the default clinical evaluation method where it is not. CONCLUSIONS: The algorithm and recommendations are based on the principles of the IDEAL-D framework for medical device evaluation and appear eminently practicable. Their use would create a safer system for monitoring innovation, and facilitate more rapid detection of potential hazards to patients and the public.

IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage.

OBJECTIVE: To extend the IDEAL framework for device innovation, IDEAL-D, to include the preclinical stage of development (stage 0). BACKGROUND: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety. METHODS: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. The group conducted a series of discussions following the principles used in the development of the original IDEAL framework. Importantly, IDEAL aims for maximal transparency, optimal validity in the evaluation of primary effects, and minimization of potential risk to patients or others. The proposals were subjected to further review and editing by members of the IDEAL Council before a final consensus version was adopted. RESULTS: In considering which studies are required before a first-in-human study, we have: (1) classified devices according to what they do and the risks they carry, (2) classified studies according to what they show about the device, and (3) made recommendations based on the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness before progression to clinical studies (stage 1). CONCLUSIONS: The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice.

What Helps and What Hinders the Creation of a Smoke-free Home: A Qualitative Study of Fathers in Scotland.

INTRODUCTION: Few studies have explored fathers' views and experiences of creating a smoke-free home, with interventions largely targeting mothers. This study aimed to identify barriers and facilitators to fathers creating a smoke-free home, to inform future intervention development. METHODS: Eighteen fathers who were smokers and lived in Scotland were recruited from Dads' community groups, Early Years Centres and through social media advertising. Semi-structured interviews explored their views and experiences of creating a smoke-free home. A theory-informed thematic analysis using the COM-B model highlighted ways in which capability, opportunity, and motivations shaped fathers' home smoking behaviors. RESULTS: Several fathers understood the health risks of second-hand smoke exposure through public health messaging associated with recent smoke-free legislation prohibiting smoking in cars carrying children. Limited understanding of effective exposure reduction strategies and personal mental health challenges reduced some fathers' ability to create a smoke-free home. Fathers were keen to maintain their smoke-free home rules, and their motivations for this largely centered on their perceived role as protector of their children, and their desire to be a good role model. CONCLUSIONS: Fathers' abilities to create a smoke-free home are shaped by a range of capabilities, opportunities, and motivations, some of which relate to their role as a father. Establishing a fuller understanding of the contextual and gender-specific factors that shape fathers' views on smoking in the home will facilitate the development of interventions and initiatives that fathers can identify and engage with, for the broader benefit of families and to improve gender equity and health. IMPLICATIONS: Our findings can inform future development of father-centered and household-level smoke-free home interventions. They identify fathers' views and experiences and help reframe smoking in the home as a gendered family-wide issue, which is important in building consensus on how best to support parents to create a smoke-free home. Our findings highlight the need for additional research to develop understanding of the ways in which gender-related aspects of family structures, heterosexual relationships, and child living arrangements influence home smoking rules and how to tailor interventions accordingly.

Am I safe? An Interpretative Phenomenological Analysis of Vulnerability as Experienced by Patients With Complications Following Surgery.

Abdominal surgery carries with it risks of complications. Little is known about patients' experiences of post-surgical deterioration. There is a real need to understand the psychosocial as well as the biological aspects of deterioration in order to improve care and outcomes for patients. Drawing on in-depth interviews with seven abdominal surgery survivors, we present an idiographic account of participants' experiences, situating their contribution to safety within their personal lived experiences and meaning-making of these episodes of deterioration. Our analysis reveals an overarching group experiential theme of vulnerability in relation to participants' experiences of complications after abdominal surgery. This encapsulates the uncertainty of the situation all the participants found themselves in, and the nature and seriousness of their health conditions. The extent of participants' vulnerability is revealed by detailing how they made sense of their experience, how they negotiated feelings of (un)safety drawing on their relationships with family and staff and the legacy of feelings they were left with when their expectations of care (care as imagined) did not meet the reality of their experiences (care as received). The participants' experiences highlight the power imbalance between patients and professionals in terms of whose knowledge counts within the hospital context. The study reveals the potential for epistemic injustice to arise when patients' concerns are ignored or dismissed. Our data has implications for designing strategies to enable escalation of care, both in terms of supporting staff to deliver compassionate care, and in strengthening patient and family involvement in rescue processes.

The IDEAL Reporting Guidelines: A Delphi Consensus Statement Stage Specific Recommendations for Reporting the Evaluation of Surgical Innovation.

OBJECTIVE: The aim of this study was to define reporting standards for IDEAL format studies. BACKGROUND: The IDEAL Framework and Recommendations establish an integrated pathway for evaluation of new surgical techniques and complex therapeutic technologies. However guidance on implementation has been incomplete, and incorrect use is commonly seen. We describe the consensus development of reporting guidelines for the IDEAL stages, and plans for their dissemination and evaluation. METHODS: Using the EQUATOR Network recommendations, participants with knowledge of IDEAL were surveyed to determine which IDEAL stages needed reporting guidelines. Draft checklists for stages 1, 2a, 2b, and 4 were subsequently developed by 3 researchers (N.B., A.H., P.M.), and revised through a 2-round Delphi consensus process. A final consensus teleconference resolved outstanding disagreements and clarified wording for checklist items. RESULTS: Sixty-one participants completed the initial survey, a clear majority indicating that new reporting guidelines were needed for IDEAL Stage 1 (69.5%), Stage 2a (78%), Stage 2b (74.6%), and Stage 4 (66%). A proposed set of checklists was modified by survey participants in 2 online Delphi rounds (n = 54 and n = 47, respectively), resulting in a penultimate checklist for each stage. Fourteen expert working group members finalized the checklist items and successfully resolved any outstanding areas without agreement on a consensus call. CONCLUSIONS: Participants familiar with IDEAL called for reporting guidelines for studies in all IDEAL stages except stage 3. The checklists developed have the potential to improve standards of reporting and thereby advance the quality of research on surgery and complex interventions and technologies, but require further evaluation in use.

How might the 'Icelandic model' for preventing substance use among young people be developed and adapted for use in Scotland? Utilising the consolidated framework for implementation research in a qualitative exploratory study.

BACKGROUND: Substance use among young people is a significant public health concern, particularly in Scotland. Primary prevention activities are essential in delaying young people's substance use and reducing the harms associated with use. However, such prevention activities are generally lacking. The Icelandic Model (IM) has received increasing attention and has been associated with improvements in substance use in Iceland since the 1990s. There is interest in implementing the IM in Scotland but concerns regarding transferability. This research study aimed to address a gap in the evidence base by providing insight into stakeholders' views of the IM in Dundee and more widely in Scotland. METHODS: Qualitative data were collected via semi-structured telephone interviews with 16 stakeholders. Data were analysed using Framework Analysis in NVivo, informed by the Consolidated Framework for Implementation Research. RESULTS: Participants were keen for more prevention activities to be delivered in Scotland and were generally supportive of the IM, given the high rates of substance use and related harm. A range of positive factors were identified, including the evidence base, the multi-component nature of the IM, and availability of current services that could be embedded into delivery. Several barriers were noted, relating to funding, the franchise model, support and buy-in and cultural differences. CONCLUSIONS: Our findings provide insight into the views of a range of stakeholders regarding the potential implementation of the IM in Scotland, and perceived barriers and facilitators. There is a desire for primary prevention activities in Scotland, driven by concerns about high rates of substance use and related harms, and a general lack of effective and evidence based prevention activities across the country. Several key barriers would need to be addressed in order for implementation to be successful, and participants were clear that initial piloting is required. Future research and evaluation is required to examine its potential and the outcomes of the approach in Scotland.

The IDEAL framework in neurosurgery: a bibliometric analysis.

BACKGROUND: The Idea, Development, Exploration, Assessment and Long-term study (IDEAL) framework was created to provide a structured way for assessing and evaluating novel surgical techniques and devices. OBJECTIVES: The aim of this paper was to investigate the utilization of the IDEAL framework within neurosurgery, and to identify factors influencing implementation. METHODS: A bibliometric analysis of the 7 key IDEAL papers on Scopus, PubMed, Embase, Web of Science, and Google Scholar databases (2009-2019) was performed. A second journal-specific search then identified additional papers citing the IDEAL framework. Publications identified were screened by two independent reviewers to select neurosurgery-specific articles. RESULTS: The citation search identified 1336 articles. The journal search identified another 16 articles. Following deduplication and review, 51 relevant articles remained; 14 primary papers (27%) and 37 secondary papers (73%). Of the primary papers, 5 (36%) papers applied the IDEAL framework to their research correctly; two were aligned to the pre-IDEAL stage, one to the Idea and Development stages, and two to the Exploration stage. Of the secondary papers, 21 (57%) explicitly discussed the IDEAL framework. Eighteen (86%) of these were supportive of implementing the framework, while one was not, and two were neutral. CONCLUSION: The adoption of the IDEAL framework in neurosurgery has been slow, particularly for early-stage neurosurgical techniques and inventions. However, the largely positive reviews in secondary literature suggest potential for increased use that may be achieved with education and publicity.

Development and evaluation of an electronic hospital referral system: a human factors approach.

Coordinating care across hospitals has been identified as a patient safety risk as referrals are often paper-based and poorly documented. Electronic referral systems have the potential to improve the situation but can fail to gain uptake. We applied a human factors/ergonomics (HFE) approach to place analysis of local workflow and user engagement central to the development of a new regional electronic referral system. The intervention was evaluated with a before-and-after study. Referral quality improved, referrals containing sufficient clinical information for continuation of care increased from 36.9% to 83.5% and completeness of referral information significantly improved. There was a 35.7% reduction in the number of calls to the on-call specialist, and the mean period between admission and surgery for expedited transfers was reduced. Applying HFE informed design with use-based evidence; the system maintains sustained uptake three years after implementation. Reliable recording of information translates to better patient safety during inter-hospital transitions. Practitioners summary: This study developed, implemented and evaluated a clinical referral system using a human factors approach. Process analysis and usability studies were used to inform the application requirements and design. Region-wide implementation in hospitals resulted in the improved quality and completeness of clinical referral information and efficiencies in the referral process.

No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations.

OBJECTIVE: To update, clarify, and extend IDEAL concepts and recommendations. BACKGROUND: New surgical procedures, devices, and other complex interventions need robust evaluation for safety, efficacy, and effectiveness. Unlike new medicines, there is no internationally agreed evaluation pathway for generating and analyzing data throughout the life cycle of surgical innovations. The IDEAL Framework and Recommendations were designed to provide this pathway and they have been used increasingly since their introduction in 2009. Based on a Delphi survey, expert workshop and major discussions during IDEAL conferences held in Oxford (2016) and New York (2017), this article updates and extends the IDEAL Recommendations, identifies areas for future research, and discusses the ethical problems faced by investigators at each IDEAL stage. METHODS: The IDEAL Framework describes 5 stages of evolution for new surgical therapeutic interventions-Idea, Development, Exploration, Assessment, and Long-term Study. This comprehensive update proposes several modifications. First, a "Pre-IDEAL" stage describing preclinical studies has been added. Second we discuss potential adaptations to expand the scope of IDEAL (originally designed for surgical procedures) to accommodate therapeutic devices, through an IDEAL-D variant. Third, we explicitly recognise the value of comprehensive data collection through registries at all stages in the Framework and fourth, we examine the ethical issues that arise at each stage of IDEAL and underpin the recommendations. The Recommendations for each stage are reviewed, clarified and additional detail added. CONCLUSIONS: The intention of this article is to widen the practical use of IDEAL by clarifying the rationale for and practical details of the Recommendations. Additional research based on the experience of implementing these Recommendations is needed to further improve them.

Progress in clinical research in surgery and IDEAL.

The quality of clinical research in surgery has long attracted criticism. High-quality randomised trials have proved difficult to undertake in surgery, and many surgical treatments have therefore been adopted without adequate supporting evidence of efficacy and safety. This evidence deficit can adversely affect research funding and reimbursement decisions, lead to slow adoption of innovations, and permit widespread adoption of procedures that offer no benefit, or cause harm. Improvement in the quality of surgical evidence would therefore be valuable. The Idea, Development, Exploration, Assessment, and Long-term Follow-up (IDEAL) Framework and Recommendations specify desirable qualities for surgical studies, and outline an integrated evaluation pathway for surgery, and similar complex interventions. We used the IDEAL Recommendations to assess methodological progress in surgical research over time, assessed the uptake and influence of IDEAL, and identified the challenges to further methodological progress. Comparing studies from the periods 2000-04 and 2010-14, we noted apparent improvement in the use of standard outcome measures, adoption of Consolidated Standards of Reporting Trials (CONSORT) standards, and assessment of the quality of surgery and of learning curves, but no progress in the use of qualitative research or reporting of modifications during procedure development. Better education about research, integration of rigorous evaluation into routine practice and training, and linkage of such work to awards systems could foster further improvements in surgical evidence. IDEAL has probably contributed only slightly to the improvements described to date, but its uptake is accelerating rapidly. The need for the integrated evaluation template IDEAL offers for surgery and other complex treatments is becoming more widely accepted.

Combining Systems and Teamwork Approaches to Enhance the Effectiveness of Safety Improvement Interventions in Surgery: The Safer Delivery of Surgical Services (S3) Program.

IMPORTANCE: Patient safety improvement interventions usually address either work systems or team culture. We do not know which is more effective, or whether combining approaches is beneficial. OBJECTIVE: To compare improvement in surgical team performance after interventions addressing teamwork culture, work systems, or both. DESIGN: Suite of 5 identical controlled before-after intervention studies, with preplanned analysis of pooled data for indirect comparisons of strategies. SETTING: Operating theatres in 5 UK hospitals performing elective orthopedic, plastic, or vascular surgery PARTICIPANTS:: All operating theatres staff, including surgeons, nurses, anaesthetists, and others INTERVENTIONS:: 4-month safety improvement interventions, using teamwork training (TT), systems redesign and standardization (SOP), Lean quality improvement, SOP + TT combination, or Lean + TT combination. MAIN OUTCOMES AND MEASURES: Team technical and nontechnical performance and World Health Organization (WHO) checklist compliance, measured for 3 months before and after intervention using validated scales. Pooled data analysis of before-after change in active and control groups, comparing combined versus single and systems versus teamwork interventions, using 2-way ANOVA. RESULTS: We studied 453 operations, (255 intervention, 198 control). TT improved nontechnical skills and WHO compliance (P < 0.001), but not technical performance; systems interventions (Lean & SOP, 2 & 3) improved nontechnical skills and technical performance (P < 0.001) but improved WHO compliance less. Combined interventions (4 & 5) improved all performance measures except WHO time-out attempts, whereas single approaches (1 & 2 & 3) improved WHO compliance less (P < 0.001) and failed to improve technical performance. CONCLUSIONS & RELEVANCE: Safety interventions combining teamwork training and systems rationalization are more effective than those adopting either approach alone. This has important implications for safety improvement strategies in hospitals.

A before-after study of multidisciplinary Out-of-Hours handover: combining management and frontline efforts to create sustainable improvement.

OBJECTIVE: The importance of implementation strategy in systems improvement is increasingly recognized and both 'bottom-up' and 'top-down' approaches have significant barriers. A trial of a combined approach involving frontline and managerial staff therefore seems merited. We attempted to improve handover using a Human Factors-based approach integrated with a combined 'top and bottom' implementation strategy. DESIGN: A before-after study was conducted across 9 months. SETTING: The study was set in a 236 bed district general hospital. PARTICIPANTS: Participants included any member of staff involved in Out of Hours handover. INTERVENTION: Existing processes were analysed using Human Factors methods. Changes made were based on this analysis and developed via facilitation between management and frontline staff. These included creating a single multidisciplinary handover, changing the venue, standardizing the meeting structure, developing an standard operating procedure for identifying unwell patients for handover and creating a clinical coordinator role. MAIN OUTCOME MEASURES: Meeting attendance, duration, start time efficiency, the type of patients handed over and the transfer of important information were measured pre- and post-intervention. RESULTS: We found improvement in handover start time (P = 0.002, r = 0) and multidisciplinary participation (P = 0.002, r = -0.534). Handover of unwell patients improved, but not significantly. Communication of plan (P < 0.001, r = 0.14) and pending tasks (P < 0.001, r = 0.30) improved, but diagnosis (P = 0.233, r = -0.05), history (P = 0.482, r = -0.03) and comorbidities (P = 0.19, r = -0.05) did not. CONCLUSIONS: The changes produced greater multidisciplinary participation, a broader focus and improved communication of plans and tasks outstanding. The 'top and bottom' implementation approach appeared valuable. Management involvement was essential for significant changes, while frontline staff involvement facilitated the design of context-specific practical solutions with staff buy-in.

Intentional Rounding: a staff-led quality improvement intervention in the prevention of patient falls.

AIMS AND OBJECTIVES: This study designed and evaluated the use of a specific implementation strategy to deliver a nursing staff-led Intentional Rounding intervention to reduce inpatient falls. BACKGROUND: Patient falls are a common cause of harm during hospital treatment. Intentional Rounding has been proposed as a potential strategy for prevention, but has not received much objective evaluation. Previous work has suggested that logical interventions to improve patient care require an integrated implementation strategy, using teamwork training and systems improvement training, to instigate positive change and improvement. METHODS: Customised Intentional Rounding was implemented and evaluated as part of a staff-led quality improvement intervention to reduce falls on a neuroscience ward. Intentional Rounding was instigated using a prespecified implementation strategy, which comprised of: (1) engagement and communication activities, (2) teamwork and systems improvement training, (3) support and coaching and (4) iterative Plan-Do-Check-Act cycles. Process (compliance with hourly visiting to patients by staff) and outcome (incidence of falls) measures were recorded pre- and postintervention. Falls measured on the active ward were compared with incidence of falls in 50 wards across the rest of the same Trust. RESULTS: There was a 50% reduction in patient falls on the active ward vs. a minimal increase across the rest of the Trust (3·48%). Customised Intentional Rounding, designed by staff specifically for the context, appeared to be effective in reducing patient falls. CONCLUSIONS: Improvement programmes based on integrating teamwork training and staff-led systems redesign, together with a preplanned implementation strategy, can deliver effective change and improvement. RELEVANCE TO CLINICAL PRACTICE: This study demonstrates, through the implementation of a specific strategy, an effective improvement intervention to reduce patient falls. It provides insight into the effective design and practical implementation of integrated improvement programmes to reduce risk to patients at the frontline.

The Safer Delivery of Surgical Services Program (S3): Explaining Its Differential Effectiveness and Exploring Implications for Improving Quality in Complex Systems.

OBJECTIVE: To analyze the challenges encountered during surgical quality improvement interventions, and explain the relative success of different intervention strategies. SUMMARY BACKGROUND DATA: Understanding why and how interventions work is vital for developing improvement science. The S3 Program of studies tested whether combining interventions addressing culture and system was more likely to result in improvement than either approach alone. Quantitative results supported this theory. This qualitative study investigates why this happened, what aspects of the interventions and their implementation most affected improvement, and the implications for similar programs. METHODS: Semistructured interviews were conducted with hospital staff (23) and research team members (11) involved in S3 studies. Analysis was based on the constant comparative method, with coding conducted concurrently with data collection. Themes were identified and developed in relation to the program theory behind S3. RESULTS: The superior performance of combined intervention over single intervention arms appeared related to greater awareness and ability to act, supporting the S3 hypothesis. However, we also noted unforeseen differences in implementation that seemed to amplify this difference. The greater ambition and more sophisticated approach in combined intervention arms resulted in requests for more intensive expert support, which seemed crucial in their success. The contextual challenges encountered have potential implications for the replicability and sustainability of the approach. CONCLUSIONS: Our findings support the S3 hypothesis, triangulating with quantitative results and providing an explanatory account of the causal relationship between interventions and outcomes. They also highlight the importance of implementation strategies, and of factors outside the control of program designers.