bluuebunny/crossref_metadata_2025 huggingface dataset:
OP354 Cost-Effectiveness Analysis Of Different Prenatal Screening Strategies For Down Syndrome In China: Data From Shandong Province
Authors: Du Yanqiu , Shang Wenru , Huang Jiayan
Published: December 2020

Introduction

There are large differences between the prenatal screening strategies for Down Syndrome (DS) in different provinces in China. In Henan province there is a serological triple screening in the second trimester (STS) strategy, while in Shandong province contingent non-invasive prenatal testing (NIPT) screening strategy (NIPT delivered to older pregnant women) is used, and there is a universal NIPT screening strategy in Anhui province. Moreover, many factors varied widely in different regions, such as the proportion of older pregnant woman and the ability of people to pay. This study aimed to determine the cost-effectiveness of current strategy in Shandong compared with strategies in other provinces.

Methods

A decision tree model was developed according to the screening strategies in different provinces. Four screening strategies were involved, universal STS strategy, contingent STS strategy, contingent NIPT strategy, and universal NIPT strategy. Cost-effectiveness analysis was conducted from a societal perspective in a simulated cohort of 100,000 pregnant women. The data of costs and epidemiologic parameters were collected from field surveys in Shangdong and a literature review.

Results

The universal STS strategy, contingent STS strategy, contingent NIPT strategy, and universal NIPT strategy could prevent 17.0, 40.0, 46.2, and 53.6 DS births, respectively. There was no strategy dominated by others. The universal NIPT strategy and contingent NIPT strategy would decrease invasive procedures for prenatal diagnosis, resulting in fewer procedure-related miscarriages. The sensitivity analysis showed that the effectiveness of the screening strategy is significantly influenced by the resident's acceptance of NIPT.

Conclusions

From the perspective of maximizing the effect, the universal NIPT strategy is the optimal strategy. But taking into account the resident's and government's ability to pay, contingent NIPT Strategy may be appropriate for the current situation in Shandong. To ensure a better cost-effective advantage in the universal NIPT strategy, the government should provide health education to increase the acceptance of NIPT while controlling the price of NIPT.
OP457 A Collaborative Horizon Scanning Alert For Disinvestment And Early Awareness
Authors: Lauvrak Vigdis , Farrah Kelly , Esmail Rosmin , Espeland Anna Lien , Hafstad Elisabet , Harboe Ingrid , Ohm Ingrid Kristine , Migliore Antonio , Topfer Leigh-Ann
Published: December 2020

Introduction

In 2019, the Norwegian Institute for Public Health and Canadian Agency for Drugs and Technologies in Health (CADTH) received support from HTAi to produce a quarterly current awareness alert for the HTAi Disinvestment and Early Awareness Interest Group in collaboration with the HTAi Information Retrieval Interest Group. The alert focuses on methods and topical issues, and broader forecasts of potentially disruptive technologies that may be of interest to those involved in horizon scanning and disinvestment initiatives in health technology assessment (HTA).

Methods

Information specialists at both agencies developed search strategies for disinvestment and for horizon scanning in PubMed and Google. The template for the alert was based on an e-newsletter developed by the Information Retrieval Interest Group. Information specialists and researchers reviewed the monthly (PubMed) and weekly (Google) search results and selected potentially relevant publications. Additional sources were also identified through regular HTA and horizon scanning work.

Results

Alerts are posted quarterly on the HTAi Interest Group website; members receive an email notice when new alerts are available. While the revised PubMed searches are identifying relevant information, Google alerts have been disappointing, and this search may need to be revised further or dropped. When the one-year pilot project ends, in Fall 2020, interest group members will be surveyed to see if the alerts were useful, and whether they have suggestions for improving them.

Conclusions

Collaborating on this alert service reduces duplication of effort between agencies, and makes new research in horizon scanning and disinvestment more accessible to colleagues in other agencies working in these areas.
OP520 Evaluating Long-Term Survival From Clinical Trials: Does Real-World Evidence Change the Paradigm?
Authors: Wang Xiaoliang , Adamson Blythe J. , Tan Katherine , Baxi Shrujal , Briggs Andrew , Ramsay Scott D.
Published: December 2020

Introduction

Both patient composition and medical care received in clinical trials may not be representative of clinical practice, yet health technology assessments (HTAs) commonly use extrapolation results from trials to estimate incremental benefit. Due to data limitations, external validation of trial extrapolations are uncommon. With the goal of better estimating the benefit of new therapies in practice, we compared long-term survival estimated from real-world patients who received therapy similar to the comparator arm of the OAK trial, a phase III study of patients with advanced non-small cell lung cancer (aNSCLC) who progressed following initial chemotherapy, to standard estimation approaches.

Methods

We estimated long-term survival from: (i) direct extrapolation of trial survival curves; and (ii) aNSCLC patients from the United States Flatiron Health Electronic Health Record ()-derived de-identified database diagnosed between January 2011 and August 2019 who received docetaxel monotherapy after platinum-doublet and had adequate organ function as well as functional status. Patients with unknown organ function and functional status were also included. Standard parametric extrapolations were applied and selected based on visual inspection and goodness-of-fit tests for each cohort.

Results

Using a log-logistic model to extrapolate the trial comparator arm (N = 425), estimated lifetime mean overall survival was 19.2 months (95% confidence interval [95% CI]: 16.5–22.6), and 14.4 months (95% CI: 12.4–17.0) for the real-world cohort (N = 415). Estimated 5-year overall survival rates were 5.4 percent (95% CI: 3.9–7.3) for the trial patients, compared to 3.7 percent (95% CI: 2.6–5.0) among real-world cohort patients.

Conclusions

Our results suggest that directly extrapolating observed survival for trial patients may overestimate the long-term survival compared to the experience of patients treated in routine practice. Our findings have implications for those wishing to estimate the incremental benefit for novel versus established treatments. We plan to compare our results to a generic patient cohort from national cancer registry. Further EHR-based studies utilizing real world data are needed to confirm our findings and to extend beyond this use case for other cancer types and anti-neoplastic therapies.
PP154 Funding Of Treatments For Rare Diseases In Singapore
Authors: Pearce Fiona , Lin Liang , Ng Kwong
Published: December 2020

Introduction

A national multi-stakeholder charity fund has been established in Singapore to provide targeted support to patients with rare genetic diseases whose treatment costs remain unaffordable despite government subsidies and insurance. This presentation will provide an overview of the evaluation, price-setting, and stakeholder engagement processes established to inform the first list of drugs eligible for funding under the Rare Disease Fund (RDF).

Methods

The local prevalence of “rare” and “ultra-rare” conditions was defined in line with international rates (≤4 in 10,000 and <2 in 50,000, respectively) to facilitate an analysis of the rare disease landscape in Singapore, and to identify patients most likely to benefit from the RDF. Public healthcare institutions proposed drugs for consideration, which underwent technical evaluation and were then assessed in line with eligibility criteria by an expert clinical group and prioritized by decision makers for funding.

Results

The number of patients with select rare diseases in Singapore was lower than global estimates contextualized to the local setting. Supporting clinical evidence, funding decisions from overseas health technology assessment agencies, reference pricing considerations, and local budget impact analyses informed the first tranche of drugs (n = 5) recommended. Extensive engagement with pharmaceutical companies was needed to negotiate fair drug prices relative to overseas countries. Additional treatments will be included in the RDF once sufficient funds are raised.

Conclusions

As the evaluation process evolves, wider considerations of disease and treatment experiences from a multi-stakeholder standpoint should be included to inform RDF listings. There is also a need to balance the sustainability of the fund in the longer term with the number of emerging treatments that may require coverage in the future.
PP164 Prescribed Medication Use, Complications, And Cost of Type 2 Diabetes Mellitus In The Real World
Authors: Chen Shengqi , Ung Carolina Oi Lam , Hu Hao
Published: December 2020

Introduction

Type 2 diabetes mellitus (T2DM) is one of the major diseases threatening the health of Chinese residents. Insufficient glycemic control results in inevitable and sometimes irreversible complications. The condition can be more complicated for patients with comorbidities. To maintain appropriate glycemic control, patients may need to add or switch to different classes of drugs as the disease progresses. The complicated drug treatment for diabetes poses a high risk for drug-drug interactions and challenges patient compliance, which is the most important factor affecting the ability to achieve glycemic control. In addition, T2DM is a life-long disease that is associated with a heavy economic burden for patients’ families and for society. Therefore, this paper aims to characterize the complexity of prescribed medications used to treat T2DM and to assess the trends in the number of complications, medications used, and costs incurred among these patients.

Methods

Data were retrieved from two tertiary hospitals. The population consisted of patients receiving at least one diagnosis of diabetes (International Classification of Diseases-10 codes: E11, E12, E13, and E14) between October 2007 and May 2017. Three measures were assessed, including the number of patients with different complications, concomitant drug use, and costs. Patients with a short disease duration (< 5 years) were compared with patients who had a longer disease duration (≥ 5 years).

Results

Of 31,071 patients, about half of those with a longer disease duration had at least five concomitant diseases, compared with nine percent of patients with a shorter disease duration. The maximum number of concomitant diseases was nine for both disease duration groups. Patients with longer disease duration were more likely to use multiple classes of drugs, compared with patients in the short disease duration group. The average annual medical costs for patients without concomitant disease was CNY 1,894 (USD 265).

Conclusions

Overall, the results demonstrated that T2DM is a relatively complex disease. Firstly, patients have up to nine concomitant diseases and use twenty-two classes of drugs. Secondly, patients with more complications tended to use more medications. Thirdly, patients with a longer disease duration tend to have a higher number of concomitant diseases, use more classes of drugs, and have higher medical costs than patients with a shorter disease duration.
PP181 Direct Comparison Of The Effectiveness And Safety Of Apixaban, Dabigatran, Rivaroxaban, And Warfarin: Subgroup Analyses Of Medicare Beneficiaries
Authors: Yang Lanting , Brooks Maria M. , Glynn Nancy W. , Zhang Yuting , Saba Samir , Hernandez Inmaculada
Published: December 2020

Introduction

No studies have directly compared the effectiveness and safety of direct oral anticoagulants (DOACs) and warfarin in patients with atrial fibrillation (AF), with or without a history of ischemic stroke and transient ischemic attack (TIA). This is important for two reasons: first, previous research reports important differences between DOACs and warfarin across other patient subgroups, and second, patients with previous stroke or TIA have a high risk of recurrent stroke.

Methods

Using 2012–2014 Medicare claims data, we identified patients newly diagnosed with AF in 2013–014 who started taking apixaban, dabigatran, rivaroxaban, or warfarin. We categorized the patients according to whether they had a history of stroke or TIA. We constructed Cox proportional hazard models that included indicator variables for treatment groups, a history of stroke or TIA, and the interaction between them, and controlled for demographic and clinical characteristics.

Results

The hazard ratio (HR) for stroke with dabigatran, compared with warfarin, was 0.64 (95% confidence interval [CI]: 0.48–0.85) for patients with a history of stroke or TIA and 0.94 (95% CI: 0.75–1.16) for patients without a history of stroke or TIA (p-value for interaction = 0.034). In patients with previous stroke or TIA, the risk of stroke was lower with dabigatran (HR 0.64, 95% CI: 0.48–0.85) and rivaroxaban (HR 0.70, 95%CI: 0.56–0.87), compared with apixaban, but there was no difference for patients in the other subgroup.

Conclusions

DOACs were generally more effective than warfarin for preventing stroke. The superiority of dabigatran was more pronounced in patients with a history of stroke or TIA. The comparative effectiveness of DOACs differed substantially between patients with and without a history of stroke or TIA; specifically, apixaban was less effective in patients with a history of stroke or TIA. Our results reinforce the need to tailor anticoagulation to patient characteristics and to support the investigation of the underlying mechanisms associated with DOACs.
PP185 Oral Health Status And Food Consumption Patterns In Selected Primary School Children
Authors: Islam Nabhira Aftabi Binte , Haque Mahmudul
Published: December 2020

Introduction

Nutrition is critical to the oral health of the individual. From gestation through to end of life, nutrition influences the integrity and function of the dentition and supporting oral structures and has a direct effect on health in general. According to the World Health Organization, diet has an important role in the prevention of oral diseases such as dental caries, dental erosion, defects in oral development, diseases of the oral mucosa, and periodontal disease.

Methods

A study was conducted to assess the oral health status and food consumption patterns of students attending the Rotary School and College at Mirpur-14, Dhaka on November 2018. Consent was provided by the school headmaster and guardians. A purposive sample of seventy students was taken. A semi-structured questionnaire and checklist was developed in the English and Bengali languages. Data were presented in simple frequency tables.

Results

Among the respondents the following eating habits were reported:

(i)

Thirty-one percent drank milk and twenty-eight percent consumed chocolate four to six times per week;

(ii)

Forty-three percent consumed fast food least seven times per week; and

(iii)

Forty-two percent ate vegetables and thirty-four percent ate fruits one to three times per week.

In terms of oral hygiene practices, sixty-one percent of respondents used toothpaste and thirty-nine percent used tooth powder. Seventy-eight percent of respondents brushed their teeth once a day and twenty-four percent brushed twice daily. The mean number of decayed, missing (due to caries), and filled permanent teeth was 1.47.

Conclusions

The relationship between oral health, dietary practices, nutritional status, and general health is complex, with many interrelated factors. To help children develop healthy eating patterns from an early age, it is important that the food and eating patterns to which they are exposed, both inside and outside the home, promote positive attitudes to good nutrition.
PP193 Research On The Correlation Mechanism Between The Psychological Contract Of Physicians In Public Hospitals And Their Medical Professionalism
Authors: Lyu Chao , Zhou Ping
Published: December 2020

Introduction

Guiding and motivating doctors' attitudes and behaviors in the public welfare of public hospitals is the key to promoting medical reform. This study explored the correlation between the hospital responsibilities perceived by physicians and their medical professionalism practices in Chinese public hospitals, and the moderating effects of variables such as sex, hospital level, working period, department, and reason for career choice on the correlation model.

Methods

A pre-developed, reliable, and valid scale for the physicians’ psychological contract was developed. Survey data from 123 public hospitals in three provinces in the east, central, and west areas of China were analyzed. The authors constructed and tested the correlation mechanism model and then analyzed the effects of particular variables.

Results

The fulfillment of hospital ideological responsibility has a significant positive effect on physicians' medical professionalism practices, with occupational satisfaction mediating the effect. In addition, hospital transactional, developmental, and relational responsibility can improve physicians’ medical professionalism practices through fairness perception and work pleasure. Hospital level, working period, department, and reason for career choice had a moderating effect on the correlation mechanism model, with the effects varying between different paths.

Conclusions

The fulfillment of hospital responsibilities can have a positive effect on physicians’ practices of medical professionalism, especially in the domain of ideological responsibility where the largest and most direct impact was observed. Furthermore, the results suggested that hospital administrators need to consider the differences between various types of physicians in order to improve the effects of guidance and motivation in these health professionals.
PP255 Epigenetic Profile Predicts Response To Immunotherapy In Patients With Non-Small-Cell Lung Cancer: An Early Assessment
Authors: Hijas-Gómez Ana Isabel , Polo-de-Santos Mª Mar , Luengo-Matos Setefilla , Carmona-Rodríguez Montserrat , Sánchez-Gómez Luís María
Published: December 2020

Introduction

Epigenetics is an innovative discipline that aims to provide biomarkers to aid in early diagnosis, patient risk classification, or outcome prediction. The identification of therapeutic targets is of particular interest in cancer therapy for selecting groups of patients who may benefit most from an intervention. Understanding the relationships between the immune system and tumor cells has led to new immunotherapy-based therapies that provide a promising alternative to conventional cancer therapies. The aim of this study was to conduct an early assessment of a novel epigenetic signature (EPIMMUNE) that could predict response to programmed cell death protein 1 (PD-1) inhibitor immunotherapy in patients with non-small cell lung cancer (NSCLC).

Methods

We identified the novel epigenetic signature EPIMMUNE through the Early Awareness and Alert System, “SINTESIS-new technologies” of the Agencia de Evaluación de Tecnologías Sanitarias in Spain (AETS-ISCIII). A literature search of PubMed, Embase, the Web of Science, the Trip database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, The Cochrane Library, and the Centre for Reviews and Dissemination databases was conducted. Clinical studies on EPIMMUNE published in English or Spanish up to August 2019 were reviewed.

Results

Only one retrospective study was found. Identification of EPIMMUNE was accomplished through interrogation of the DNA methylation status of CpG sites in 142 samples from adult patients with NSCLC who were treated with PD-1 inhibitors. EPIMMUNE was defined by 301 CpG sites whose methylation status was significantly associated with clinical response (progression-free and overall survival). No studies assessing the long-term clinical utility, impact on therapeutic decision making, or economic implications of EPIMMUNE were found.

Conclusions

The EPIMMUNE signature could provide an accurate and valid biomarker for identifying patients with NSCLC who may benefit from treatment with PD-1 inhibitors. However, the technology is under development, and there is only a single study on detecting the EPIMMUNE epigenetic profile and identifying the DNA methylation profiles associated with increased survival after PD-1 inhibitor therapy. More diagnostic accuracy studies and prospective, long-term trials are needed to evaluate the clinical impact this technology may have on therapeutic decision making. Given the limited evidence available, further research is needed before the technology can be disseminated.
PP264 Effectiveness And Safety Of Pressurized Intraperitoneal Aerosol Chemotherapy For Peritoneal Carcinomatosis: A Systematic Review
Authors: Hijas-Gómez Ana Isabel , Lingán-Cubas Nadia , Polo-de-Santos Mª Mar , García-Carpintero Esther , Luengo-Matos Setefilla , Sánchez-Gómez Luis María
Published: December 2020

Introduction

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a minimally invasive therapeutic option for stage IV or terminal stage peritoneal carcinomatosis, which has a very low survival rate. PIPAC is aimed at patients whose only therapeutic alternative is systemic chemotherapy because they are unable to undergo other treatments, such as cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. PIPAC consists of a micro-pump connected to a double-contrast injector, which is used to apply cytotoxic agents laparoscopically using pressurized aerosols. The objective of this study was to update the evidence regarding the effectiveness and safety of PIPAC.

Methods

A systematic review (SR) was conducted by searching PubMed, Embase, and The Cochrane Library database. ClinicalTrials.gov and the European Union Drug Regulating Authorities Clinical Trials Database were consulted to identify registered clinical studies. All articles published up to April 2019 were considered for inclusion. Abstracts, letters, single case studies, non-clinical and animal studies, and studies published in languages other than English or Spanish were excluded. Validated checklists were used to assess the quality of the included studies.

Results

Seventeen studies were included (three SRs and fourteen cases series) and eighteen ongoing clinical trials were identified. The quality of the SRs and cases series studies was low and moderate, respectively. Adverse events were categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events as grade 1–2 (mild-moderate: 11% to 40% of patients) and grade 3–4 (severe-fatal: 0% to 37% of patients). Overall complete histological regression according to the Peritoneal Regression Grading Score and the Peritoneal Cancer Index occurred in at least sixty percent of patients. The survival time ranged from 11 to 16 months.

Conclusions

Effectiveness data for PIPAC were promising, with high carcinomatosis regression rates. Most studies showed a moderate safety profile, with generally mild to moderate complications (nausea, abdominal pain, and vomiting). This is an advantage over systemic chemotherapy, which has severe systemic side effects. Economic evaluation studies are needed to estimate the cost effectiveness and cost utility of this technology. Diffusion of PIPAC is expected, but the criteria used to select patients in the studies carried out so far must be considered, as well as the need to follow strict safety protocols for preventing leakage of aerosolized cytotoxic drugs.
PP284 Volume-Result Relationship Analysis In Digestive Oncological Surgery In Spain By Using Health Data Records
Authors: Muñoz Laura , Puigdomènech Elisa , Cuscó Xavier Garcia , Velasco César , Espallargues Mireia
Published: December 2020

Introduction

In order to improve patients’ health outcomes, it is important to know the available evidence regarding centralization of surgical interventions for digestive cancer in hospitals with the highest volume of cases. We aim to describe and identify the number of annual interventions recommended by hospitals in order to maximize the health outcomes and efficiency for patients undergoing digestive cancer surgery during 2013–2016 in centers belonging to the Spanish National Health System (SNS).

Methods

The study design was a retrospective cohort study (patients aged ≥18 years). Data from Spanish public hospitals’ basic minimum set of data at hospital discharge for esophagus, stomach, liver, pancreas and rectum cancers was used. Age, sex primary/secondary diagnosis and procedures (Charlson index) were included. Reinterventions, hospital stay and in-hospital mortality were considered as the outcomes and measures of efficiency. Hospitals were grouped as low-/medium-/high-volume according to the number of annual procedures. Descriptive analysis and logistic and Poisson regression models with Stata16 were undertaken.

Results

High-volume hospitals performed between 67.4 (rectum) and 88.6 (liver) percent of interventions. The percentage of in-hospital mortality for all cancers was lower in high-volume centers (9.6% esophagus, 6.6% stomach, 7.1% pancreas, 4.2% liver and 2.2% rectum), showing a negative association between center volume and in-hospital mortality, which was statistically significant for esophagus (odds ratio [OR] = 0.48; 95% confidence interval [CI]: 0.28–0.81), stomach (OR = 0.51; 95% CI: 0.39–0.68) and rectum (OR = 0.63; 95% CI: 0.48–0.83) cancers. A non-statistically significant lower in hospital stay was observed in high-volume hospitals.

Conclusions

These results indicate that in Spain there is a negative association between the number of digestive oncological interventions per hospital and in-hospital mortality. This could help to define a threshold or cut-off point for the concentration of digestive cancer surgery in the SNS that might result in an improvement of lower in-hospital mortality and/or hospital stay.
PP288 Health Technology Assessment In Universal Health System: A Network At The Brazilian Capital
Authors: Silva Galdino Johnathan Portela Da , Silva Everton Macêdo , Tiziani Valdenize , Pereira Daniella Cristina Rodrigues , Camargo Erika Barbosa , Elias Flávia Tavares Silva
Published: December 2020

Introduction

Collaborative networking is adopted to implement health technology assessment (HTA) in academic and research institutions and exchange knowledge with hospitals and health services. Since 2016, the District Network for Health Technology Assessment (ReDAPTS) has been dedicated to generating and promoting evidence that supports decision-making, promoting continuous qualification, supporting and guiding managers in priorities and demands, analysing the economic, ethical and social implications of problems and situations, and contributing to healthcare quality at the Unified Health System. The objective of this study is to present the construction process of ReDAPTS from 2016 to 2019.

Methods

This experience report about ReDAPTS considered three main actions: (i) situational diagnosis in 2016 and 2017, (ii) agreements of internal regulation and governance and (iii) HTA training strategies for professionals. The scientific events and executive group meetings were described to identify the strategies for the implementation of a collaborative network in the Federal District (FD), Brazil.

Results

In total, fifteen institutions were identified with a potential to develop the HTA field at the district level. Between 2016 and 2019, three scientific events, eighteen technical meetings for network governance and two scientific meetings were carried out, organized by ReDAPTS and with 269 participants, highlighting assistance and university hospitals, FD Department of Health and academic and research institutions. Four HTA courses were offered and 319 professionals from the FD were trained.

Conclusions

Collaborative networking provided strengthening capacity for study production and debates on institutional processes for public health policies at the FD. Networking encouraged collaboration between institutions and promoted sharing HTA experiences. The network faces challenges to operate with full capacity. Political and institutional commitment, physical infrastructure and trained personnel sustainability are key to maintaining the HTA process at the FD. Institutions can develop HTA-teams to promote continuous qualification, study production and the rational use of technologies.
PP352 Systematic Review Of Clinical Effects Of Different Thermal Insulation Measures In Patients Undergoing Major Surgery
Authors: Xu He , Lu Yijuan , Guan Xin , Ma Aixia , Tang Wenxi
Published: December 2020

Introduction

Hypothermia (core temperature <36°C) during major surgeries could result in a number of adverse events such as surgical site infection, bleeding, and prolonged hospital stay. The incidence of intraoperative hypothermia was 44.3 percent in China in 2015, with only 10.7 percent of patients receiving effective hypothermia prevention measures during major surgeries. By systematically examining the adverse risks for patients using different warming measures (active and passive), our study discussed the potential of bringing the most effective one(s) into clinical guidelines.

Methods

Articles, ongoing trials and grey literatures were retrieved from PubMed, The Cochrane Library and Clinical Trials till February 2019. Bair HuggerTM (BH) was determined to be the reference group and all randomized controlled trials including BH were included. In the control group, we kept all possible warming measures. Adverse effect indicators were decided using scoping reviews and then applied in literature screening. Type (open/endoscopic) and length of surgery were included in sub-group analysis.

Results

A total of forty-two studies were included, with twenty-seven of them passive insulation measures and fifteen active measures. Compared with passive measures, BH had significant advantages, such as in surgical site infection (risk ratio [RR] = 0.13, 95% confidence interval [CI]: 0.05, 0.80), chills (RR = 0.37, 95% CI: 0.25, 0.54) and hospitalization stay (mean difference [MD]=−1.27d, 95% CI: -2.05, -0.48). Compared with active insulation measures, BH had no significant advantages. Patients with open or longer surgeries (≥2 hours) experienced higher risks.

Conclusions

Generally, an active warming system is more effective in lowering risks (e.g., hypothermia, surgical site infection, chills, length of stay) than passive ones, especially for patients going through non-endoscopic or longer surgeries. Among the active warming systems, BH does the same job as other active insulation measures. Given that the practice of peri-operative hypothermia prevention using active warming systems is not popular in China, the use of BH and other active insulation measures during major surgeries are recommended to improve the safety and potentially reduce the cost of treating those clinical adverse events.
PP434 Quality Of Studies Submitted To Support Requests For Medical Devices And Equipment Incorporation In A Teaching Hospital
Authors: Kny Katiuce Tomazi , Pires Ferreira Maria Angélica
Published: December 2020

Introduction

In hospitals with standardized processes of health technology assessment (HTA), clinical studies are usually required to support incorporation requests. Factors such as conflicts of interest and confirmation bias affect the quality of the evidence. The objective of this study was to assess the quality of studies submitted to the university hospital to support the incorporation of non-drugs technologies.

Methods

All submissions received from 2017 to 2019 were reviewed. Data about methodological quality of studies sent by requesters and their utilization of final recommendation were collected, as well as about studies retrieved during additional search performed by HTA. The Jadad and Assessing the Methodological Quality of Systematic Reviews (AMSTAR) scales were used for assessing the quality of randomized clinical trials (RCTs) and systematic reviews (SRs), respectively.

Results

Twenty-one requests for incorporation of equipment were analyzed. The average number of studies attached was 4.5. In eight requests (53.3%), both SRs and RCTs were attached. In seven (46.7%) only low quality studies were included were included; additional search identified RCTs and SRs in four of these cases. According to the Jadad and AMSTAR scales, 60 percent of the submitted RCTs showed a high risk of bias, while 57 percent of the SRs showed moderate quality, respectively.

Conclusions

The best evidence is not always submitted during the incorporation request process. Requirements for studies of moderate-to-high quality to accept the incorporation demand could be helpful to avoid inefficiencies in hospital-based HTA.
PP482 Invasive Electroencephalography In The Pre-Surgical Diagnosis Of Pharmacoresistant Epilepsy
Authors: Avdeyev Andrey , Shpekov Azat , Benberin Valeriy , Shanazarov Nasrulla , Ismailova Leilya , Akhmedullin Ruslan , Nurmasheva Arailym
Published: December 2020

Introduction

Worldwide, more than 50 million people suffer from epilepsy, and there are 16–51 new cases per 100,000 population each year. Up to 30 percent of patients with epilepsy are pharmacoresistant, who are candidates for surgical treatment. Invasive electroencephalography (iEEG) is a mandatory method in the arsenal of epileptic centers, and is gradually becoming the gold standard for invasive determination of boundaries between the affected and functional zones of the cortex and subcortical brain. Treatment costs correlate with the severity of the disease, with patients having uncontrolled seizures incurring eight times the costs compared to those with controlled epilepsy.

Methods

To assess the clinical and cost-effectiveness of the iEEG in the pre-surgical diagnosis of pharmacoresistant epilepsy, a systematic search of literature by keywords in the MEDLINE database was conducted. The search resulted in sixty-six articles. The analysis included twenty studies that met the search criteria.

Results

Most studies including meta-analysis show very low rates of complications of iEEG. Literature data demonstrate cost-effectiveness of the method in patients with pharmacoresistant epilepsy in comparison with continued antiepileptic drug therapy. As an integrated method, rather than a simple method, it takes maximum account of clinical, neurophysiological and anatomical-functional data to achieve accurate localization of the epileptogenic zone. Currently, iEEG is a clinically effective method to improve the safety and specificity of resective surgery.

Conclusions

With the use of iEEG, mortality and disability of patients with pharmacoresistant epilepsy will be significantly reduced. It has also been proven that epilepsy surgery leads to significant financial savings in the treatment of pharmacoresistant epilepsy. The results of the clinical and economic evaluation (mini-HTA report) have been submitted to the Ministry of Healthcare for decision-making on including iEEG in government reimbursement system.
PP499 Disinvestment Supported By A Hospital-Based Health Technology Assessment Unit: A Case Of A Teaching Hospital In Brazil
Authors: Schlatter Rosane Paixão , Kny Katiuce Tomazi , Ferreira Maria Angelica Pires
Published: December 2020

Introduction

The Hospital de Clínicas de Porto Alegre (HCPA), a public teaching hospital, has a Hospital-based Health Technology Assessment (HB-HTA) unit to support the decision-making process on technology incorporation, rationalization or disinvestment. In 2017, the plastic adhesive drape was standardized at HCPA for use in cardiovascular, digestive, orthopedic, and neurological surgery for the purpose of preventing surgical site infection (SSI). This study evaluated whether the plastic adhesive drape technology is more effective than the no adhesive drapes in the surgical procedures in which it is used in the HCPA, so as to support the medical board's decision regarding the rationalization of use.

Methods

The primary outcome was the surgical site infection rate (SSI). Searches were performed in PubMed, Cochrane and national and international health agencies: World Health Organization (WHO), National Institute for Health and Care Excellence (NICE), Centers for Disease Control and Prevention (CDC), Society for Healthcare Epidemiology of America (SHEA), Brazilian National Commission for the Incorporation of Technologies (CONITEC) and Brazilian National Health Surveillance Agency (ANVISA) databases. The search strategy combined terms related to the technology and types of surgery in which it is used in the HCPA. The quality of the included studies was assessed. Additionally, data on technology utilization and costs in the hospital were analyzed.

Results

Technology assessment followed AdHopHTA project recommendations. Data from the hospital showed that the technology has been used in fifteen surgical specialties, different from the proposed incorporation, with a progressive increase in consumption from 2017 to 2018. The literature review included a systematic review with seven clinical trials, which concluded that the plastic adhesive drape lacks benefits, with potential for increased risk of SSI. The evidence was of moderate quality.

Conclusions

The expenses associated with the use of the technology were considered unjustified as it is not reimbursed by the Brazilian Ministry of Health and its disinvestment was recommended. The Medical Board approved the disinvestment of the technology based on the evidence found by the HB-HTA unit, and the medical staff complied with the decision.
PP506 Health Technology Reassessment (HTR) Of A Non-Drug Technology: Methods Used By A Regional HTA Unit
Authors: Poirier Marie-Belle , Benkhalti Maria , Joncas Jérémy , Warrari Ouifak El , Addad Aghiles , Cheng Sonia , Mior Frédéric , Méziat-Burdin Anne , Dagenais Pierre
Published: December 2020

Introduction

An environmental scan conducted by the Canadian Agency for Drugs and Technologies (CADTH-March-2019) revealed that several health technology assessment (HTA) organisations are currently developing standard health technology reassessment (HTR) processes. Here we present methods used to conduct an HTR of a prioritization programme for non-immediate life-threatening urgent surgeries implemented in 2017 at a tertiary referral hospital in (Quebec-Canada). This HTR initiative was conducted by a regional HTA unit to optimize the programme efficiency and resources utilization as well as to motivate change in the clinical community of other hospitals within its healthcare network. Patient and healthcare personnel satisfaction levels towards the programme were also considered.

Methods

In this case study, HTR methods and outputs were elaborated using elements presented in the CADTH environmental scan and relevant publications identified through PubMed and in the grey literature. Documents in English and French, published between January 2002 and March 2019 were considered. Key stakeholders were consulted to identify barriers of the programme implementation to other hospitals in regards to aspects related either to the local medical practice or organizational factors.

Results

The prioritization process was conducted using the same tool applied for HTA appraisal with the additional criterion that the HTR could facilitate the programme implementation. The research processes used in this HTR included: i) systematic review of the literature, ii) hospital database search (efficacy and resource utilization), iii) perceptions of healthcare teams and patients. HTR outputs consist of specific recommendations on implementation barriers and methods to monitor the impacts of the programme.

Conclusions

In this evolving field, sharing lessons from HTR methods provides information to develop standard adaptable processes to different contexts. Hence, this work applies HTR to a healthcare programme while most of the literature focuses on the HTR processes on drug and interventional medicine disinvestment. These elements represented HTR methods used from prioritization appraisal, research processes for evaluation and outputs used to plan the implementation and finally monitoring from a regional HTA unit. It also showcases that HTR being conducted as a structured evidence-based assessment adds value to a healthcare programme and could also facilitate its implementation.
PP531 Quality Of Life Of Patients With Long-Chain Fatty Acid Oxidation Disorders Before And During Treatment With Triheptanoin
Authors: Kruger Eliza , Marsden Deborah , Bensimon Arielle , Cook Erin , Orvis Eli , Yang Hongbo , Mayhew Jill , Thomas Nina
Published: December 2020

Introduction

Long-chain fatty acid oxidation disorders (LC-FAOD) are a group of serious diseases in which patients are at risk of metabolic decompensation, resulting in cardiomyopathy, hypoglycemia and rhabdomyolysis and premature mortality. In addition, LC-FAOD are a burdensome disease that adversely effects quality of life (QoL) via symptoms of muscle pain, fatigue, and a difficult diet. Previous studies have reported improvements in QoL during treatment with triheptanoin as measured by short form (SF) instruments. This study sought to convert the QoL measure into a utility value for a sample of patients with LC-FAOD at baseline and 78 weeks during treatment with triheptanoin.

Methods

In an open-label Phase 2 study of triheptanoin (UX007-CL201, NCT01886378), caregivers of patients (n = 9/23 enrolled) or patients aged 18+ years (n = 6/6 enrolled) completed the SF-10 or the SF-12v2, respectively. Component summary scores at baseline and 78-week during treatment period were converted to EuroQol-Five Dimension (EQ-5D) utility (with zero representing death and 1.0 perfect health) using a published conversion algorithm (Lawrence and Fleishman 2004). Generalized linear mixed-effects models with individual-level random effects were used to estimate the utility values.

Results

At baseline, patients’ utility was estimated to be 0.365 (standard error [SE] = 0.090) compared with 0.629 (SE = 0.072) 78-weeks during treatment, a significant improvement (p = 0.0073). In a sensitivity analysis using SF-12v2 data only (that is, only adult patients), utility estimates were 0.498 (SE = 0.084) at baseline versus 0.690 (SE = 0.068) during treatment (p = 0.0499). No patients had a major clinical event during the SF instrument recall period, indicating the benefit was driven by day-to-day improvement in QoL.

Conclusions

Treatment with triheptanoin resulted in a substantial improvement in daily QoL for patients with LC-FAOD. Limitations of this study include that the estimation of utilities is from a single-arm study with small sample sizes and that the assessment of utility was based on a conversion algorithm rather than direct measurement. Nevertheless, results indicate significant improvement in QoL for patients treated with triheptanoin.
On the role of contestations, the power of reflexive authority, and legitimation problems in the global political system
Authors: Zürn Michael
Published: December 2020

This response to my critics discusses four claims that are central forA Theory of Global Governance. The first claim is that observing a high level of conflict and contestation in world politics is not proof of the unimportance of global governance, since many of the current conflicts and contestations are about international institutions. The second claim is that the 1990s saw a rise of trans- and international authority beyond the nation-state that is essential for the rise of a global political system. Third, a global system of loosely coupled spheres of authority relies on ‘critical deference’ (reflexive authority) but also contains numerous elements of coercion. And fourth, a technocratic legitimation of intrusive international authorities cannot build on emotions or a sense of belonging. This deficit creates a political opportunity structure that allows for the rise of a myriad of dissenters. The relative importance of them depends on the availability of resources for mobilization and not on the quality of reasons for resistance.
Locating (new) materialist characters and processes in global governance
Authors: Leander Anna
Published: December 2020

This contribution probesA Theory of Global Governancefrom a materialist perspective. I focus on three forms of materialisms that have played a significant role in social theory as well as International Relations theory: the materialisms of markets, of artefacts, and of embodied affects. Integrating these materialisms serves to unsettle the conceptualization of global governance and of the politics of authority, legitimacy, and contestation underpinning it. A materialist perspective moves the theory of global governance towards a focus on processes instead of institutions, allowing it to capture both the multiple forms of global governance and their increasingly rapidly shifting forms. The contribution is anchored in a discussion of the global governance of cyber-security.
Global governance in the age of epistemic authority
Authors: Pouliot Vincent
Published: December 2020

Today's global governance is qualitatively different from the past, according to Michael Zürn's penetrating analysis. With the rise of epistemic authority, reflexivity, service, and request have come to surpass command and control as key modes of global governance, leading to new forms of legitimation and contestation. I engage with this rich and thought-provoking argument on three counts. First, it remains doubtful that states defer to international organizations because the latter ‘know better’. There exist many gaps in epistemic authority and politics often trump rationality in global governance. Second, it is not clear how global hierarchy, which Zürn equates with ‘pockets of authority’, could emerge out of demands and requests, precisely because epistemic authority is so fluid and prone to contestation. Third, as historically young and increasingly based on service authority as it may be, contemporary global governance still rests on a body of inherited practices whose legitimation principles seem closer to tradition than to reflexive justification.
Rule and resistance in global governance
Authors: Deitelhoff Nicole , Daase Christopher
Published: December 2020

A Theory of Global Governance is a long awaited book that finally theorizes the increasing authority of international institutions and the conflicts emerging from it. With its focus on reflexive deference as a basis for international authority it covers important elements of global governance but also leaves some critical blind spots regarding the forms of super- and subordination. In our engagement with Michael Zürn's book we propose to conceptualize international authority as a subcategory of international rule instead of its essence and to investigate various forms of rule by way of analyzing the resistance they provoke instead of institutionalized mandates.
Meditating deformalization: remarks on ‘Of experts, helpers, and enthusiasts’
Authors: Bueger Christian
Published: December 2020

Moving away from studying actors to studying practices opens a fascinating vista of global governance. Kratochwil provokes inquiry into the practical work actual people do in international relations. He helps to move beyond binaries by offering a pragmatic approach to global governance in a fragmented institutional environment. Yet, his criticism of best practices for their problems of applicability and perverse side-effects misses the existence of different kinds of best practices. Some of them have been highly successful, such as the ‘Best Management Practices to Deter Piracy in the Gulf of Aden and off the Coast of Somalia’. One should not underestimate the potential of practices in both advancing scientific knowledge and ‘real-world’ change.