bluuebunny/crossref_metadata_2025_split huggingface dataset:
VP18 Potential Of Real World Evidence For ‘IDEAL’ Procedures Research
Authors: Poole Ruth Louise , Myles Susan , Carolan-Rees Grace 
Published: December 2019

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.
VP25 HTA Enables Nurses To Discontinue Continuous ECG Monitoring
Authors: Mitchell Matthew , Lavenberg Julia , Holland Sara , Mull Nikhil , Williams Kendal 
Published: December 2019

IntroductionProviders frequently issue orders for telemetry (continuous ECG monitoring) of hospital inpatients, but they rarely issue orders to discontinue telemetry. This can cause telemetry beds to be unavailable for patients who need them.MethodsOur hospital health technology assessment (HTA) center conducted a rapid systematic review of evidence on algorithms, guidelines, and other tools for nurses to identify patients who no longer need telemetry. Databases searched included Medline, CINAHL, the Cochrane Library, National Guideline Clearinghouse, and Joanna Briggs Institute.ResultsWe found no guidelines or existing systematic reviews of nurse-driven protocols for discontinuing telemetry. There were three published articles describing projects where protocols for discontinuing telemetry were tested. All three of these studies were of low methodologic quality. They all found that use of the protocol reduced the number of hours of telemetry monitoring that were used in the hospital. Two studies published in letter form reported adaptations of computerized order entry systems where nurses assess the patient's readiness for discontinuing telemetry and either discontinue telemetry or report to the ordering physician when the stated discontinuation criteria are met.ConclusionsOur hospitals are now implementing the HTA findings in our electronic ordering system.
VP26 HTA In Nursing: Scoping Trends With An ICF Component Analysis
Authors: Wübbeler Markus , Geis Sebastian 
Published: December 2019

IntroductionNursing is a worldwide growing but still underdeveloped health technology assessment (HTA) field. A systematic overview about the current trends in HTA and nursing would shed some light on the issues of (i) the HTA base in this sector, and (ii) outcomes addressed with the interventions and technologies.MethodsWe conducted a scoping review using the National Health Service (NHS) Centre for Reviews and Dissemination HTA database, including all abstracts of HTA reports related to nursing. To systemize the interventions and technologies assessed in the HTA reports, we designed an International Classification of Functioning, Disability and Health (ICF) Map connecting the targeted healthcare outcomes with the components of the ICF Classification.ResultsWe identified seventy-eight HTA reports related to nursing care, published between the years 1992 and 2018. Overall, forty-four reports did not outline any particular outcome and had to be categorized as unclear. The remaining thirty-four reports addressed three ICF components (body functions, activities/ participation, environmental factors) with sixty-eight ICF content categories. Frequent ICF contents were services, systems and policies (code e5, n = 15), cardiovascular/ respiratory functions (code b4, n = 10), mental functions (code b1, n = 7), digestive functions (code b5, n = 7), domestic life (code d6, n = 7), and sensory functions/ pain (b2, n = 6). Six HTA reports evaluated interventions/ technologies with presumed effects on at least four ICF content categories from two ICF components.ConclusionsHTA in the field of nursing is often complex, including multicomponent approaches and a wide range of potential outcomes relevant for the HTA assessment. The ICF model might be useful to support a more streamlined understanding of complex interventions in this sector. Furthermore, reports might benefit from linking the ICF Classification with HTA, especially for the assessment of complex interventions.
VP39 The Alphabet Lottery? How NICE Outcomes Vary By Appraisal Committee
Authors: Macaulay Richard , Liu Lok Wan , Roibu Cornelia , Berardi Andrea 
Published: December 2019

IntroductionNICE (National Institute for Health and Care Excellence) makes recommendations on the public reimbursement of medicines based on their clinical- and cost-effectiveness. The recommendation is made by an Appraisal Committee (comprising a multi-disciplinary group of independent experts) as part of a technology appraisal. There are four Appraisal Committees (A,B,C,D); this research investigates whether appraisal outcomes vary by committee.MethodsAll publicly-available Final Appraisal Determinations from NICE Single Technology Appraisals (STA) were screened (01/10/2009-14/11/2018) and key data were extracted. Homogeneity in rates of acceptance or rejection across the committees was assessed using Chi-squared tests.ResultsThe Appraisal Committee was identified for 298 technologies, 56% (168/298) of which were ‘recommended’. The number of technologies assessed by each committee was similar (A:79, B:62, C:91, D:66). However, STAs conducted by Committee D were significantly less likely to receive ‘recommended’ outcomes (A:68% [54/79], B:65% [40/62], C:53% [48/91], D:39% [26/66]; p < 0.01). STAs for oncology indications had higher ’not recommended’ outcomes than those for non-oncology indications (25% vs. 9%). The lower ‘recommendation’ rates for committee D persisted across oncology (A:60%, B:83%, C:50%, D:38%; p = 0.01) and non-oncology indications (A:73%, B:53%, C:55%, D:40%; p < 0.01). However, STAs conducted by Committee D were significantly more likely to receive ‘optimized’ recommendations (A:16%, B:21%, C:33%, D: 36%; p < 0.01) and when considering the rates of ‘recommended’ and ‘optimized’ outcomes compared to ‘only in research’ and ‘not recommended’ outcomes, no significant differences were found (A:85%, B: 85%, C:86%, D:76%; p = 0.27).ConclusionsSTAs undertaken by NICE Appraisal Committee D was associated with a significantly lower rate of ‘recommended’ outcomes but tended to an ‘optimized’ recommendation significantly more than the other committees. Further research is needed to determine if this reflects any deviation in uniform implementation of NICE methodology between Committees.
VP55 Trial Recruitment & Retention Using Digital Tools: A Qualitative Study
Authors: Blatch-Jones Amanda , Worswick Louise , Bull Abby , Nuttall Jacqui , Griffiths Gareth , Wyatt Jeremy 
Published: December 2019

IntroductionRecruitment of participants and their retention in randomized controlled trials (RCTs) is key for research efficiency. However, for many trials, recruiting and retaining participants meeting the eligible criteria is extremely challenging. Digital tools are increasingly being used to identify, recruit and retain participants. While these tools are being used, there is a lack of quality evidence to determine their value in trial recruitment.MethodsThe aim of the main study was to identify the benefits and characteristics of innovative digital recruitment and retention tools for more efficient conduct of RCTs. Here we report on the qualitative data collected on the characteristics of digital tools required by trialists, research participants, primary care staff, research funders and Clinical Trials Units (CTUs) to judge them useful. A purposive sampling strategy was used to identify 16 participants from five stakeholder groups. A theoretical framework was informed from results of a survey with UKCRC registered CTUs. Semi-structured interviews were conducted and analysed using an inductive approach. A content and thematic analysis was used to explore the stakeholder's viewpoint and the value of digital tools.ResultsThe content analysis revealed that ‘barriers / challenges ‘ and ‘awareness of evidence’ were the most commonly discussed areas. Three key emergent themes were present across all groups: ‘security and legitimacy of information’, ‘inclusivity’, and ‘availability of human interaction’. Other themes focused on the engagement of stakeholders in their use and adoption of digital technology to enhance the recruitment/retention process. We also noted some interesting similarities and differences between practitioner and participant groups.ConclusionsThe key emergent themes clearly demonstrate the use of digital technology in the recruitment and retention of participants in trials. The challenge, however, is using these existing tools without sufficient evidence to support the usefulness compared to traditional techniques. This raises important questions around the potential value for future research.
VP57 Using Capital Bids For Hospital-Based Health Technology Assessment
Authors: Erskine Jamie , Chalkidou Anastasia 
Published: December 2019

IntroductionThe Evelina London Children's Hospital (ELCH) is undergoing a period of growth, including a new building planned to be completed within the next five years. Due to limited space and ambitions to be a state-of-the-art hospital, Horizon Scanning (HS) was considered important to ‘future-proof’ new facilities. As the aim of HS is to identify signals of coming change, ‘scanning’ the previous five years’ trends may be beneficial to an iterative HS methodology. Thus, it was thought that capital bids could provide a range of useful information required to make procurement decisions.MethodsKing's Technology Evaluation Centre (KiTEC) provided hospital-based HTA and HS support for the expansion of a London-based paediatric hospital. KiTEC focused on imaging technology due to its large spatial requirements and high-costs and assessed all capital bids made over the previous five years. A capital bidding system is used within GSTT to allocate funding for medical equipment that costs more than GBP5000 (USD 6540.70). Information was collated for all imaging equipment bid for over the previous five years and assessed for trends in imaging modalities and purchase costs.ResultsA total of 135 bids were made in the period 2013-2018, eight of which were by ECLH. Bids for ultrasound equipment were most common and rose over the period. Bids for CT scanners also rose, while bids for MRI scanners and x-ray technology were consistent and bids for fluoroscopy fell. The total cost of imaging bids over the interval rose steadily from GBP5.4 million to GBP6.9 million.ConclusionsDue to the lifespan of imaging technology, some trends may not emerge within a five year window. While some interesting findings were made, a ten to fifteen year period may require to be scanned for a robust analysis. This methodology is best applied in an iterative fashion along with standard HS techniques.
VP62 The EUnetHTA Companion Guide: A New Repository To Support European HTA
Authors: Luhnen Miriam , Fathollah-Nejad Reza , Nocon Maya , Hutner Heike , Rehrmann Maike , Chalon Patrice , Fujita-Rohwerder Naomi 
Published: December 2019

IntroductionGood quality management (QM) and the sound application of EUnetHTA's (European network for Health Technology Assessment) well-established methodology and tools are fundamental prerequisites for reliable and trustworthy joint work. To provide ultimate support and guidance to the assessment teams of EUnetHTA – and further, to ensure a sustainable mode of work for the post-2020 period – a comprehensive web-based so called “EUnetHTA Companion Guide” is established in Joint Action 3.MethodsThe Companion Guide was created using the open source Wiki software “DokuWiki”. We divided the content into five main parts: 1. EUnetHTA's QM concept, 2. QM for rapid Relative Effectiveness Assessment (REA) Pharma, 3. QM for rapid REA Other Technologies (OT) 4. Scientific Guidance & Tools and 5. QMS-related training material. The assessment processes for rapid REA Pharma and OT have been subdivided into single process steps for which the Companion Guide provides standard operating procedures (SOPs), checklists, templates, guidelines and tools. The content of the Companion Guide is continuously subjected to evaluation by means of a structured survey with regard to the achievement of its purpose of ensuring to ensure high-quality HTA reports.ResultsIn May 2018, the Companion Guide was launched and is now available to all EUnetHTA partners. It provides central access to all components of the newly established QMquality management system for EUnetHTA. The user has access to training modules that provide information on how to use the Companion Guide. Moreover, the training material enables EUnetHTA partners to build up necessary capabilities for QMquality management, and application of methodologies and tools in the context of EUnetHTA.ConclusionsThe purpose of the Companion Guide is to ensure the production of high-quality HTA reports by providing ultimate support and guidance to the EUnetHTA assessment teams during their joint work. The continuous evaluation will reveal necessary revisions and the need for further developments and guidance.
VP74 Orphan Black Box: Explanatory Principles
Authors: Wang George , Macaulay Richard 
Published: December 2019

IntroductionOrphan legislations over the past thirty years have successfully increased the number of drugs receiving marketing authorization for rare diseases. However, for a therapy to be accessible to most patients, it requires not only marketing authorization, but market access via public reimbursement. In many major markets, the pricing and reimbursement of new therapies is based on an assessment by a national Health Technology Assessment (HTA) body, for which economic value is typically a key consideration. This research evaluates the outcome of HTAs of orphan drugs in Europe.MethodsHTA decision data (to 31/08/2017) was extracted from Gemeinsame Bundesausschuss (G-BA), Haute Autorité de Santé (HAS), National Institute for Health and Care Excellence (NICE), Pharmaceutical Benefits Advisory Committee (PBAC), and Scottish Medicines Consortium (SMC) websites. EC-approval data was extracted from the European Medicines Agency (to 31/08/2017).ResultsOnly a small minority of drugs for orphan diseases received full recommendations for their licensed indication(s) by NICE (3/35, 9%), SMC (8/66, 12%) and PBAC (1/44, 2%). 37% (26/70) of drugs assessed received positive HTA outcome by HAS (ASMR I-III). In Germany, all approved orphan drugs (100/100) received automatic additional benefit post regulatory approval by G-BA.ConclusionsThere have been significant challenges for manufacturers in converting regulatory approval of orphan drugs into commercial success and optimised market access. Attaining positive HTA appraisals for these drugs, which have been approved under expedited regulatory pathways on a less than fully mature dataset, whilst also having high prices, due to small patient populations, limiting commercial returns, may necessitate increased utilisation of alternative reimbursement mechanisms.
VP82 Impact of Evidence Synthesis Methods on Outcome of Economic Evaluation
Authors: Gorry Claire , Leahy Joy , Lamrock Felicity , Walsh Cathal , White Arthur , Barry Michael , McCullagh Laura 
Published: December 2019

IntroductionEvidence synthesis (ES) is often required for economic evaluation (EE) of pharmaceuticals. Commonly used methods are based on the assumption of proportional hazards in trial data, using the hazard ratio (HR). Alternative methods for ES are increasingly used in EE, in situations where the pattern of hazards in the trial data indicates that the proportional hazards assumption may be violated. The impact of these methodological choices on model outcomes is explored.MethodsA network of trials of BRAF-targeted treatments for advanced melanoma, derived using a systematic review of the literature, is chosen for the study. Guyot's method is used to create individual-patient Kaplan-Meier (K-M) data from published survival curves. Log-cumulative hazard plots and Schoenfeld residuals are derived to examine patterns in hazards within the trial data. All analyses are conducted in R version 3.5.0©. Three alternative methods for ES are tested: 1) Network meta-analysis (NMA) based on published HRs and the assumption of proportional hazards. 2) NMA using fractional polynomials (FP) based on digitised K-M data, allowing the relaxation of the proportional hazards assumption. 3) NMA using an accelerated failure time (AFT) model based on digitised K-M data, allowing the relaxation of the proportional hazards assumption. The derived estimates of relative efficacy from each method are applied in a partitioned survival cost-effectiveness model programmed in Microsoft Excel™.ResultsThe model outcomes predicted by each method (HR, FP and AFT) are presented and compared. Both deterministic and probabilistic results are presented, alongside a discussion around how the uncertainty in these structural assumptions may be captured in EE.ConclusionsStructural assumptions in ES may lead to differences in model outcomes. The impact of these differences may be important in situations where decision uncertainty is high. Methods should be chosen and justified based on patterns of hazard present in the trial data.
VP89 A Preliminary Equity Checklist To Support The HTA Process
Authors: Benkhalti Maria , Dagenais Pierre 
Published: December 2019

IntroductionThere is increased recognition of the need to include equity considerations in HTA. Despite this, a recent World Health Organization report has found that this is seldom the case. We developed a preliminary version of an equity checklist in the hopes that tangible guidance will increase such analyses in the future and contribute to smart capability building.MethodsThe checklist is based on the Equity Framework for HTA developed by Culyer & Bombard (2012). The elements presented in the framework were revised to follow the stepwise HTA process. A comprehensive literature search was used to update and complete the elements. The checklist was then piloted in an HTA in 2018 and subsequently further refined through a workshop during a national HTA conference in Canada.ResultsThese steps resulted in a 27-item checklist leading to consider different aspects of the three major phases in the HTA process. The scoping phase brings questions relative to defining and contextualizing equity, such as highlighting potential minority groups and including vulnerability factors in the logic model. The development phase leads methodological approaches facilitating the analysis of inequities as well as considering contextual realities leading to inequities. The last phase, drafting of recommendations, aims to be aware of the evidence synthesis approaches as well as the various aspects to ensure recommendations consider existing inequities and avoid contributing to their development.ConclusionsGiven the essence of HTA to protect health by ensuring optimal technologies and interventions are adopted to the benefit of all system users, the consideration of inequities should constitute an integral part of its process. The use of a pragmatic and simple checklist to aid the planning of an HTA could contribute to greater consideration of inequities in the future. A movement in this direction could also lead to greater methodological developments for health equity analysis in HTA.
VP100 Ultraradical Ovarian Cancer Surgery Comparative Clinical Effectiveness
Authors: Cummins Carole , Patrick Hannah , Long Joanna , Kumar Satyam , Sundar Sudha , Bramley George 
Published: December 2019

IntroductionOvarian Cancer is usually diagnosed at an advanced stage. Extensive or ultra-radical surgery aims to improve the outcome by removing all visible tumour. National Institute for Health and Care Excellence UK 2013 Guidance expressed concern about its efficacy and safety, recommending research comparing complication rates, survival and quality of life with those following standard surgery. We present prospective observational data on quality of life and survival following surgery for advanced ovarian cancer. Innovative methods were used to collect patient reported outcomes and complex surgical information to compare outcomes of surgery of greater or lesser complexity used in routine practice.MethodsA cohort study collected disease, surgical, complications, survival and quality of life data (validated instruments including EURO-QOL, EORTC-30 and OVA28) across a 2-year period in 12 United Kingdom sites and in parallel studies in Melbourne, Australia and Kolkata, India.ResultsTwo hundred and sixty patients undergoing cytoreductive surgery were recruited in 12 months. Centres varied in utilisation of complex surgical procedures. Excluding patients with inoperable disease, 125 patients underwent low, 70 intermediate and 63 high Surgical Complexity Score (SCS) procedures. Complete cytoreduction with < 1cm residual disease was achieved in 100/125 (80 percent) low, 65/70 (92 percent) intermediate, and 57/63 (90 percent) high SCS groups (p = 0.023). Compliance with 12 months questionnaires was 89%. All surgical groups had improved EORTC QLC 30 Global at 12 months compared with prior to operation, with overlapping 95% confidence intervals and no between group differences at 12 months. Complications, survival and quality of life adjusted for disease burden and surgical complexity over 2 years’ follow-up will be described.ConclusionsResults will inform the update of NICE Interventional Procedures guidance recommendations on clinical governance arrangements for ovarian cancer surgery and enable clinicians and patients to better understand the outcomes of surgery, informing the consent process.