bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP222 Efficacy And Safety Of Foot Reflexology
Authors: del Mar Trujillo-Martín Mª , Pino.Sedeño Tasmania Del , Leon-salas Beatriz , García Javier García , Brito Néstor Benitez , Gonzalez Asunción Gaitán , Rodríguez Leticia Rodríguez , de Alba Inmaculada Guerrero Fernández , Aguilar Pedro Serrano 
Published: December 2021

IntroductionFoot reflexology is a type of complementary manual therapy that consists of applying pressure or massage to the sole of the foot to produce various therapeutic effects in other body areas or organs. This technique has been used in many different clinical indications, but there is uncertainty about its real effect. A health technology assessment (HTA) was conducted to analyze the efficacy and safety of foot reflexology within the framework of the “Health Protection Plan Against Pseudo-Therapies,” which was established in 2018 by the Spanish Ministry of Health and the Ministry of Science and Innovation.MethodsA systematic review and metanalysis was conducted to synthesize the available scientific literature on the efficacy and safety of foot reflexology in people of any age with any disease or medical condition.ResultsSixty-eight randomized controlled studies were included. Pooled estimates indicated that foot reflexology had no effect on pain, fatigue, depression, quality of life, quality of sleep, or blood pressure, compared with non-reflexological foot massage. Improvements in pain (standardized mean difference [SMD] −1.11, 95% CI: −1.70 - −0.52), fatigue (SMD −0.93, 95% CI: −1.36 - −0.51), sleep quality (SMD −1.11, 95% CI: −1.68 - −0.34), and systolic (mean difference [MD] −7.36, 95% CI: −8.49 - −6.23) and diastolic (MD −5.07, 95% CI: −0.98 - −0.22) blood pressure were obtained when reflexology was compared with usual care or no intervention. In the case of anxiety levels, the benefit obtained with foot reflexology compared with any comparator (SMD −0.6, 95% CI: −0.98 - −0.22) was attenuated when compared with non-reflexological foot massage (SMD −0.2, 95% CI: −0.36 - −0.03). Very few studies reported on the safety of foot reflexology.ConclusionsThere was no evidence for any specific effect of reflexology for any condition when compared with non-reflexological foot massage, except for a positive effect on anxiety levels.
PP230 Safety, Effectiveness, And Cost Effectiveness Of Interventions For Preventing Delirium In Hospitalized Patients
Authors: León-Salas Beatriz , Linertová Renata , García-García Javier , Pérez-Ros Pilar , Rivas-Ruiz Francisco , Toledo-Chávarri Ana , Trujillo-Martín María M. 
Published: December 2021

IntroductionDelirium is a prevalent syndrome in the hospital setting and the elderly are the most affected. The objective was to assess the safety, clinical effectiveness, and cost effectiveness of interventions for preventing delirium among people aged 65 years or older at hospital admission.MethodsA systematic review of available scientific literature (randomized controlled trials) on the safety, effectiveness, and cost effectiveness of the interventions was conducted. The overall effect size for each type of intervention was estimated through a meta-analysis. A cost-effectiveness study in the context of the Spanish National Healthcare System was performed.ResultsForty-nine studies were included for the effectiveness and safety assessment (25 on pharmacological interventions, 12 on perioperative interventions, 2 on non-pharmacological interventions, and 10 on multicomponent interventions). The following interventions reduced delirium incidence relative to usual care or placebo: hypnotics and sedatives (13 studies; risk ratio [RR] 0.54: 95% confidence interval [CI] 0.36–0.80); perioperative interventions aimed at limiting opioid use (two studies; RR 0.50, 95% CI: 0.29–0.86); controlling the intensity of general anesthesia (three studies; RR 0.77, 95% CI: 0.59–0.99); and multicomponent interventions (10 studies; RR 0.62, 95% CI: 0.54–0.72). In addition, multicomponent interventions reduced the duration (mean difference −1.18, 95% CI: −1.95 - −0.40) and severity of delirium (standardized mean difference −0.98, 95% CI: −1.46 - −0.49), while dexmedetomidine reduced the duration of delirium (mean difference −0.70, 95% CI: −1.03 - −0.37).The economic analysis of a multicomponent preventive intervention estimated an average cost of EUR7,282 per patient, which was EUR140 per patient more expensive than usual care. The incremental cost-effectiveness ratio was EUR21,391 per quality-adjusted life-year, which is below the acceptability threshold used in Spain. The literature review yielded two economic evaluations that estimated the cost effectiveness of a multicomponent intervention in the United Kingdom and found that the multicomponent intervention was a dominant strategy.ConclusionsThis meta-analysis suggests that multicomponent interventions and dexmedetomidine are effective in reducing the incidence of delirium in hospitalized patients and that multicomponent interventions could be a cost-effective strategy in Spain.
PP231 Safety, Effectiveness And Economic Analysis Of Exercise Intervention For Prevention Of Cognitive And Functional Deterioration In Hospitalized Patients
Authors: León-Salas Beatriz , Linertová Renata , García-García Javier , Pérez-Ros Pilar , Rivas-Ruiz Francisco , Toledo-Chávarri Ana , Trujillo-Martín María M. 
Published: December 2021

IntroductionCognitive and functional deterioration is common in hospital setting and occurs in 40 percent of admitted older patients. One of its main causes is physical inactivity. The objective of our health technology assessment was to assess the safety and clinical effectiveness of a structured multicomponent intervention of physical exercise (Vivifrail) for the prevention of the cognitive and functional deterioration in hospitalized patients aged 70 years or older and to estimate costs and the budgetary impact for the Spanish National Health Service.MethodsA systematic review of available scientific literature (including experimental and observational designs) on the safety and effectiveness of Vivifrail was performed. A costing study and budgetary impact analysis of the incorporation of Vivifrail as a therapeutic alternative to standard care with a time horizon of 5 years was performed.ResultsOne randomized controlled trial (RCT) (n = 370) showed positive effects of Vivifrail compared to usual care in functional capacity (mean difference (MD) = 2.20, 95% confidence interval (CI) 1.78 to 2.62), cognitive state (MD = 1.80, 95% CI 1.24 to 2.36), and quality of life (MD = 13.20, 95% CI 12.70 to 13.70). Regarding other variables, the Vivifrail increased the grip strength of the dominant hand (MD = 2.30; 95% CI = 1.79 to 2.81), verbal fluency (MD = 2.15; 95% CI = 1.56 to 2.74), performance of double tasks (MD = 0.10; 95% CI = 0.07 to 0.13), executive function (MD = −31.07; 95% CI = −49.23 to −12.91) and emotional state (MD = −2.00; 95% CI = −2.50 to −1.50).The total cost of implementing Vivifrail in a 1,000-bed general hospital would be EUR18,000 per year (adjusted to 2020 currency), with approximately 150 patients older than 75 years benefited. This represents a cost of EUR120 per patient.ConclusionsThe Vivifrail could improve functional and cognitive capacity, although available evidence on the Vivifrail is very scarce. More well designed and executed RCT and cost-effectiveness study confirming or refuting the promising findings are needed for a new assessment.
PP254 Double-Counting In Evidence Synthesis Including Routinely Collected Data: Methodological and Practical Considerations
Authors: Hussein Humaira , Nevill Clareece , Meffen Anna , Bujkiewicz Sylwia , Sheehan Nuala , Sutton Alex , Abrams Keith , Gray Laura 
Published: December 2021

IntroductionThe use of real-world data, as an alternative to randomized controlled trials, is becoming increasingly common in the evaluation of new health technologies. With this rise in real-world literature, such data will also enter evidence synthesis models. While it can be beneficial to utilize data from all available sources, this can introduce the problem of double-counting of participants.MethodsUsing a number of case-studies, we discuss and illustrate various issues around double-counting. These include synthesis of studies using the same database or the same subset of participants, overlapping use of intervention arms across studies and the use of registry data from the participants overlapping with those in randomized controlled trials. The implications in research are considered along with common methods used currently to overcome these issues.ResultsDouble-counting of participants in evidence synthesis can artificially inflate precision, potentially leading to inappropriate conclusions. Common methods currently used to help mitigate the impact of double-counting includes stratifying analysis to different timelines, using the most comprehensive study in the evidence synthesis model or using the study that has the largest sample size. However, in all of these cases, sensitivity analyses would need to be considered to ensure robust results.ConclusionsCurrently, there are no published guidelines on how to address the issue of double-counting. With the increased use of real-world data in evidence synthesis, double-counting has the potential to become a significant issue. Therefore, it is of significant importance that methodologies and guidelines are developed to address this.
PP290 Ongoing Swedish Initiatives To Improve The Potential For Real World Data Assessment Of Medical Devices
Authors: Hedblom Amanda Hansson , Saunders Rhodri 
Published: December 2021

IntroductionIn 2020, the Swedish regions cemented a national managed-introduction project for medical devices, to ensure equal, cost-effective, and appropriate use. Health technology assessment (HTA) is an important component of the project. Swedish national health registers have world-class coverage and completeness but may lack information enabling adequate evaluation of medical devices. This study reviews the current situation and ongoing initiatives. Additionally, the potential for medical device health economics and outcomes research (HEOR) using Swedish registers is assessed.MethodsA review of Swedish national health registers was undertaken, focusing on available data, and contextualized for the purpose of HEOR for medical devices. Additionally, the review included an evaluation of the Swedish reimbursement authority's (The Dental and Pharmaceutical Benefits Agency, TLV) ongoing initiatives to improve the potential to follow-up the impact of the technologies they assess and develop value-based pricing schemes.ResultsFive registers were deemed the most relevant national health registers for device research. They include high-quality longitudinal data and are linkable on a per-patient basis. For devices, main limitations include limited data on specialized outpatient care, lags in updating certain registers, lack of laboratory data, and challenges in identifying the specific device used. Reports indicate that certain limitations are being addressed, including pilot-studies investigating the opportunity for automated reporting of data from regional systems, and app-collected patient-reported health data.ConclusionsSwedish registers provide comprehensive sources for HEOR studies, but limitations related to the assessment of medical device impact remain. As is common with register data reporting grouped diagnoses and interventions, specific devices are not directly identifiable in the national health registers. For some devices, this might be addressable through linkage with other data-sources. Swedish authorities are undertaking several initiatives that will likely improve the potential for HTA and follow-up of medical devices using national health register data.
PP296 Patient Involvement In An Assessment Of The Management Of Sudden Onset Severe Headache Presenting To The Emergency Department
Authors: Wade Ros , Walton Matthew , Harden Melissa , Hodgson Robert , Eastwood Alison , Storey James , Hassan Taj , Randall Marc , Hassan Abu , Williams John 
Published: December 2021

IntroductionSudden onset severe headache is usually caused by a primary headache disorder but may be secondary to a more serious problem, such as subarachnoid hemorrhage (SAH). Very few patients who present to hospital with headache have suffered a SAH, but early identification is important to improve patient outcomes. A systematic review was undertaken to assess the clinical effectiveness of different care pathways for the management of headache, suspicious for SAH, in the Emergency Department. Capturing the perspective of patients was an important part of the research.MethodsThe project team included a patient collaborator with experience of presenting to the Emergency Department with sudden onset severe headache. Three additional patients were recruited to our advisory group. The patient's perspective was collected at various points through the project including at team meetings, during protocol development and when interpreting the results of the systematic review and drawing conclusions.ResultsPatients were reassured by the very high diagnostic accuracy of computed tomography (CT) for detecting SAH. Patients and clinicians emphasized the importance of shared decision making about whether to undergo additional tests to rule out SAH, after a negative CT result. When lumbar puncture was necessary, patients expressed a preference to have it on an ambulatory basis; further research on the safety and acceptability of ambulatory lumbar puncture was recommended.ConclusionsPatient input at the protocol development stage helped researchers understand the patient experience and highlighted important outcomes for assessment. Patient involvement added context to the review findings and highlighted the preferences of patients regarding the management of headache.
PP298 Scottish Health Technologies Group (SHTG) Adaptations: Utilizing Other Agencies’ HTAs In Scotland
Authors: Anand Neil , Campbell Evan , Macgann Tracey , Kelly Joanna , Calvert Julie 
Published: December 2021

IntroductionHealth Technology Assessment (HTA) is an important but time-consuming process to inform decision-making. Following requests from stakeholders in Scotland to provide advice on technologies that had recently undergone HTA in other jurisdictions, SHTG recognized a gap in their ‘product menu’. Colleagues within the SHTG team devised a mechanism through which an original HTA could be adapted for Scotland, taking into account local contextual factors.MethodsSHTG Adaptations comprise the following: i) assessment of the original HTA using the EUnetHTA HTA Adaptation Toolkit and checklist; ii) draft Adaptation using the outcome of the assessment and contextual information for Scotland; iii) consultation group of relevant Scottish clinicians is provided with the original HTA and draft SHTG Adaptation; iv) modified Delphi approach (max. three rounds of questioning) is used to ascertain the relevance of the original HTA to Scotland; v) the Adaptation is submitted to SHTG Council for endorsement.ResultsSHTG Adaptations have a timeline of 2–3 months, three have been published since this product was launched. The process has run smoothly with excellent clinical engagement from across NHS Scotland. Key learning focusses on the role of the SHTG Council (i.e. appraisal committee) in this process and in handling of expert opinion of evidence which has already been appraised by another agency.ConclusionsThe SHTG Adaptation is a new product which offers a timely assessment and utilization of an HTA from another agency.
PP299 A Framework And Analysis Assessing The Impact Of Patient-Centered Outcome Evidence In HTA Appraisals
Authors: Halsby Kate , Langford Bryony , Pagotto Anna , Tuson Harriet , Collings Shuk-Li , Goncalves-Bradley Daniela , Yasmeen Najeeda , Burton Jessica 
Published: December 2021

IntroductionThe importance of patient-centered outcome (PCO) evidence is increasingly recognized, but its inclusion in Health Technology Assessment (HTA) submissions remains inconsistent. We explored the impact of PCO evidence on HTA decision-making.MethodsA framework was developed to assess the impact of PCO evidence (excluding EQ-5D) on HTA appraisals. An impact rating was determined by reviewing company, committee and Evidence Review Group (ERG) opinion. This was applied to publicly available appraisal documents (National Institute for Health and Care Excellence [NICE]: 8; Scottish Medicines Consortium [SMC]: 2) in a pilot study. The framework was then refined and applied to a larger dataset.ResultsPCO evidence had ‘substantial impact’ in 3/8 NICE and 1/2 SMC appraisals, and ‘some impact’ in those remaining. PCO evidence informed the cost-effectiveness model in 2/8 NICE and 1/2 SMC submissions, and was considered superior to EQ-5D evidence in one NICE and one SMC submission. The ERG considered PCO evidence relevant to decision-making in 5/8 NICE appraisals. PCO evidence was mentioned in guidance for 7/10 appraisals (deemed relevant in 5/10). In one assessment, committee comments were notably more favorable than ERG comments. Larger dataset analysis results provided further insights to the pilot study.ConclusionsThe framework allows a systematic approach to evaluating the impact of PCO evidence on HTA appraisals.BL, AP, DGB and NY are employees of Symmetron Ltd, which received funding from Pfizer UK in connection with the development of this manuscript. KH, HT, SLC and JB are employees of Pfizer UK. This study was sponsored by Pfizer UK.
PP403 New Medical Technology Adoption In Asia Pacific: Focused On South Korea And Japan
Authors: Hwang Hyojung 
Published: December 2021

IntroductionThis study is the first to analyze and compare the distinctive market access process of new medical technologies focused on technical fee creation in South Korea and Japan. The purpose of this study is to derive implications for each country through analysis and comparison of the market access process and propose improvements of new medical technology adoption program by referring the United States’ incentive program for innovative technology.MethodsIdentification and review the published articles and health polices, and reports related to the medical procedure (medical technologies) coding and payment rule in South Korea, Japan and the United States.ResultsIn Korea, for the rapid introduction of new medical technologies, a One-Stop Service program (aka parallel review process) is operated that simultaneously conducts regulatory approval and new health technology assessment (nHTA) process. In Japan, the Sakigake designation program aims to give patients better access to innovative pharmaceuticals, medical technologies, and regenerative medicines by streamlining the approval and pricing process but it doesn't provide immediate coverage after approval. Medicare Coverage for Innovative Technology (MCIT) is one of the incentive programs for innovative technology which aims to improve patient access to new medical technologies through rapid market access process in the United States. Medical technologies designated a Breakthrough Device receive immediate Medicare Coverage for 4 years by MCIT.ConclusionsIt is recommended for Korea and Japan to actively implement the accelerated patient access process and grant affordable premium prices for the innovative medical technologies. MCIT can be considered as a breakthrough for innovative medical technology adaption.
PP428 Rechargeable Versus Recharge-Free Sacral Neurostimulation: An Australian Health Economics Analysis
Authors: Joglekar Rashmi , Cordato Alexandra 
Published: December 2021

IntroductionSacral neuromodulation is a well-established therapy for urinary and fecal incontinence. Currently available sacral neurostimulators require replacement every three to five years due to battery depletion. New rechargeable sacral neurostimulators with a potential 15-year battery life now have regulatory approval in Australia. However, the initial outlay for the device is higher than for the predicate devices. Our objective was to assess the economic value of rechargeable devices, compared with recharge-free implants, and to identify the patients most likely to benefit from the introduction of this novel technology in Australia.MethodsThe Medicare database was reviewed to quantify populations likely to derive benefits from rechargeable technology. Cost minimization and budget impact analyses were conducted from a payer perspective. Cost inputs were derived from Medicare and the Private Hospital Data Bureau. Two scenarios were modeled comparing the three and five-year battery life of the recharge-free devices with 15 years for a rechargeable device. Sensitivity testing was conducted based on potential uptake and dropout rates (due to death, dementia, etc.).ResultsRechargeable neurostimulators were found to be dominant (cost-saving) in all modeled scenarios, facilitated by a reduction in the frequency of battery replacement procedures and their associated risks for patients. Rechargeability also facilitated higher power settings for optimal symptom control, without trading off device longevity. Younger patients are expected to derive the greatest benefit from the extended battery life as data showed that 40 percent of the implantations were for patients younger than 65 years. The key uncertainty in this analysis was the limited real-world data on patient selection and preferences, which may influence uptake and dropout rates.ConclusionsRechargeable sacral neurostimulators deliver cost savings to the healthcare system due to their extended battery life. Fewer replacement surgeries are an important patient-relevant outcome, especially for younger populations. This finding is important because it demonstrates the economic value of rechargeability to payers and provides robust evidence supporting therapy access for privately insured patients in Australia.