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Background Perioperative hypothermia during laparoscopy for bowel resection is a risk factor for postoperative medical complications and surgical wound infections. Despite various warming methods used during surgery, a significant number of patients experience perioperative hypothermia. Use of dry, unwarmed insufflation carbon dioxide (CO2) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO2 for insufflation, can reduce the risk of perioperative hypothermia. Objective The aim is to determine if insufflation with warmed, humidified CO2 using the HumiGard device, alongside standard perioperative warming techniques, can improve patient recovery, including pain, surgical site infections, complications, and the use of analgesia compared with standard care alone. Methods The study is a multicenter, randomized, blinded (patient, surgeon, and assessor), sham device-controlled, parallel group-controlled trial of 232 patients. The study aims to recruit patients undergoing elective laparoscopic, segmental, or total colectomy. Patients will be randomized to receive HumiGard plus standard care or standard care alone (1:1 ratio). The primary outcome is patient-reported quality of recovery, measured by the validated QoR-40 (quality of recovery) questionnaire, from baseline to postoperative day 1. Secondary outcomes include postoperative pain, the incidence of hypothermia, and the rate of postoperative complications. Results The information gathered during a small-scale service evaluation at a single hospital was used to inform this study protocol. Before applying for a grant for this full randomized controlled trial, the authors will conduct a feasibility study of 40 patients to ensure that the protocol is feasible and to inform our sample size calculation. Conclusions The randomized controlled trial is designed to provide high-quality evidence on the effectiveness of the HumiGard device in potentially reducing the risk of perioperative hypothermia in patients scheduled for laparoscopic colectomy. The results will be used to improve the maintenance of adequate patient body temperature during surgery. International Registered Report Identifier (IRRID) PRR1-10.2196/14533

The Axonics sacral neuromodulation (SNM) system can be used by people with refractory overactive bladder (OAB) to reduce symptoms of urge urinary incontinence and urinary frequency, where conservative treatments have failed or are not suitable. It is the first system for this indication that makes use of a rechargeable battery to prolong the lifespan of the implanted device, with the potential advantage of reducing the frequency of surgical replacement procedures and associated complications. We describe the evidence considered by the UK National Institute of Health and Care Excellence (NICE) in their evaluation of this evidence, supported by Cedar Healthcare Technology Research Centre. Two observational studies provided descriptive data that suggested improvement in control of symptoms after implantation of the Axonics SNM system; however, there was no peer-reviewed evidence that directly compared rechargeable and non-rechargeable SNM systems. In the absence of long-term data, economic modelling relies on the accuracy of battery life estimates. The evidence supports the case for adopting the Axonics SNM system for treating refractory OAB, when conservative treatment or treatment with medicines has not worked. This conclusion is consistent with other relevant NICE guidelines. Use of Axonics SNM technology in the UK National Health Service (NHS) is associated with a potential cost saving of £6025 per person over a 15-year period when compared with an equivalent non-rechargeable SNM system, assuming the claimed battery life estimate (a minimum of 15 years) is accurate. The cost savings are estimated to start around 6 years after implantation. Key Points for Decision MakersPublished evidence from two non-comparative observational studies suggests that use of the Axonics Sacral Neuromodulation (SNM) system can help people with overactive bladder (OAB) to manage symptoms of urinary frequency and urinary incontinence.National Institute of Health and Care Excellence (NICE) concluded that the Axonics SNM system should be considered as an option for people with refractory OAB when conservative treatment or treatment with medicine has not worked.

IntroductionWales has ambitious health, wealth, and innovation policies and a clear goal to use the economic muscle of the Welsh National Health Service (NHS) to support its strong life sciences sector. Health Technology Wales (HTW) has a clear remit to appraise technologies over the span of their lifecycle from innovation to obsolescence. HTW is collaborating with the Bevan Commission through their national Health Technology Exemplars (HTEs), which partners NHS and industry stakeholders to strengthen innovation within the Welsh health system.MethodsHealth technology assessment (HTA) methods were used to produce topic exploration reports for assessing the evidence underpinning applicant innovations. A “Dragons’ Den” expert panel was convened to select the successful HTEs.ResultsFourteen Bevan HTEs were awarded funds, which were matched by industry partners. Application of HTA methods resulted in more critical consideration of technology value propositions, including: developing pull models of innovation focused on delivering health technology solutions for current problems facing NHS Wales; supporting early dialogue between the NHS and industry partners around demonstrating evidence of improved patient outcomes; and focusing on transformative rather than incremental innovation. The most promising innovations will progress to rapid HTA, where the evidence generated will be used to develop guidance for NHS Wales.ConclusionsHTA methods were productively deployed at the innovation phase of the technology lifecycle to support evidence-informed allocation of scarce innovation resources. In this way, HTW is working with key stakeholders to identify and offer early support to the most promising innovations, with the aim of expediting their adoption and realizing health benefits for patients as quickly as possible. The Bevan Commission has partnered with HTW to routinely build in HTA and evidence considerations in its future innovation calls and competitions. Thus, HTW has established a “feeder” pipeline for assessing bottom-up service-led innovations and encouraging evidence consideration throughout the lifecycle of innovative technologies.

BACKGROUND Perioperative hypothermia during laparoscopy for bowel resection is a risk factor for postoperative medical complications and surgical wound infections. Despite various warming methods used during surgery, a significant number of patients experience perioperative hypothermia. Use of dry, unwarmed insufflation carbon dioxide (CO₂) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO₂ for insufflation, can reduce the risk of perioperative hypothermia. OBJECTIVE The aim is to determine if insufflation with warmed, humidified CO₂ using the HumiGard device, alongside standard perioperative warming techniques, can improve patient recovery, including pain, surgical site infections, complications, and the use of analgesia compared with standard care alone. METHODS The study is a multicenter, randomized, blinded (patient, surgeon, and assessor), sham device-controlled, parallel group-controlled trial of 232 patients. The study aims to recruit patients undergoing elective laparoscopic, segmental, or total colectomy. Patients will be randomized to receive HumiGard plus standard care or standard care alone (1:1 ratio). The primary outcome is patient-reported quality of recovery, measured by the validated QoR-40 (quality of recovery) questionnaire, from baseline to postoperative day 1. Secondary outcomes include postoperative pain, the incidence of hypothermia, and the rate of postoperative complications. RESULTS The information gathered during a small-scale service evaluation at a single hospital was used to inform this study protocol. Before applying for a grant for this full randomized controlled trial, the authors will conduct a feasibility study of 40 patients to ensure that the protocol is feasible and to inform our sample size calculation. CONCLUSIONS The randomized controlled trial is designed to provide high-quality evidence on the effectiveness of the HumiGard device in potentially reducing the risk of perioperative hypothermia in patients scheduled for laparoscopic colectomy. The results will be used to improve the maintenance of adequate patient body temperature during surgery.

IntroductionEffective communication is vital for engaging stakeholders in health technology assessment (HTA), as well as the successful dissemination and adoption of HTA research and guidance. As a relatively new organization, Health Technology Wales (HTW) has an ideal opportunity to take an effective, strategic approach to communication and stakeholder engagement from the outset.MethodsHTW commissioned Pagoda Public Relations to develop an informed communications strategy and delivery framework. The strategy used OASIS methodology for public relations planning: Objectives, Audience insight, Strategy, Implementation, and Scoring (evaluation). Initial objectives were developed with input from the HTW team and members of the HTW Assessment Group and Appraisal Panel. Stakeholder insights were collected through an online survey and telephone interviews. These insights were used to inform the communications strategy and framework, outlining key audiences, key messages, communication objectives, methods, tactics, and evaluations.ResultsSeven key objectives were identified, each of which were supported by recommended actions. These were underpinned by the key aims and messages reflecting how we will achieve these objectives. National Health Service boards, government, clinicians, the technology and research sector, patients, and the general public were identified as priority audiences. Various different communication channels and activities were identified, aimed at various audiences. These included the website, social media, traditional media, and exhibitions or workshops, as well as targeted e-mail dissemination of guidance. Evaluation of HTW communications will be aligned with the wider HTW evaluation strategy, and evidence will be recorded through OutNav software (Matter of Focus Ltd).ConclusionsHTW is committed to a strategic, effective approach to communication and engagement. We now have an audience-informed communications strategy and plan that outlines our key objectives, and how to achieve and evaluate these objectives. Successful implementation will raise awareness of and value in profile and outputs of HTW, both in Wales and internationally.

IntroductionRandomized trials and similarly robust research methods generate evidence in carefully controlled settings, often with strict inclusion criteria. But patients in the ‘real world’ often have multiple comorbidities, and treatments are delivered within diverse environments. Trials are also difficult to fund, and rarely collect longitudinal data. Because of these, and other limitations, researchers are increasingly recognizing the inherent value of real world evidence (RWE). This is not only true for pharmaceutical products, and may have even more relevance in the evaluation of complex interventional procedures and non-medicines healthcare technologies. The Idea, Development, Exploration, Assessment, Learning (IDEAL) Framework guides the developmental ‘pipeline’ of surgical (and other) procedures, as well as medical device research (IDEAL-D). IDEAL informs the production of high-quality evidence of safety and effectiveness, but there is potential to further expand its applications.MethodsOur aim is to investigate the feasibility of using of RWE alongside the IDEAL Framework in the assessment of procedures and devices. Methodological experts from the IDEAL Collaboration, HTA agencies and other healthcare research organisations are contributing their unique perspectives and experiences to explore these methods. As part of this work, Cedar Healthcare Technology Research Centre (Cedar) has attempted to retrospectively apply the IDEAL criteria to a series of RWE projects conducted on behalf of the National Institute for Health and Care Excellence (NICE) Interventional Procedures and Medical Technologies Evaluation Programmes.ResultsCedar's experience indicates that there may be options for using retrospective routinely-collected linked data and other existing sources to address some of the requirements of IDEAL. Likewise, the IDEAL Framework is expected to be a helpful reference when designing new databases and clinical registries for prospective collection of relevant and informative evidence. Examples from several projects will be shared at the Health Technology Assessment International (HTAi) conference.ConclusionsInitial signs are that there are likely to be a number of ways in which IDEAL and RWE could complement one another.

The Department of Health in England want to see NHS commissioners and providers capitalize upon the expertise of the independent sector for the benefit of NHS patients. In preparing for the future what does the sector have to offer NHS nurses and how will this benefit patient care? This paper examines the role of independent providers and the way they are helping NHS commissioners and providers to break new ground in delivering more accessible and convenient care for NHS patients at home.