bluuebunny/crossref_metadata_2025 huggingface dataset:
Bodily Maps of Emotion in Major Depressive Disorder
Authors: Lyons Naomi , Strasser Alexa , Beitz Bernard , Teismann Tobias , Ostermann Thomas , Anderle Laura , Michalak Johannes
Published: December 2020

Background

Emotions play a central role in mental disorder and especially in depression. They are sensed in the body, and it has recently been shown in healthy participants that these sensations can be differentiated between emotions. The aim of the current study was to assess bodily sensations for basic emotions induced by emotion eliciting pictures in depression.

Methods

30 healthy controls (HC), 30 individuals suffering from Major depressive disorder (MDD) without medication use (MDDnm) and 30 individuals with MDD with medication use (MDDm) were shown emotional and neutral pictures and were asked to paint areas in an empty body silhouette where they felt an increase or decrease in activation. Body sensation maps were then calculated and statistical pattern recognition applied.

Results

Results indicated statistically separable activation patterns for all three groups. MDDnm showed less overall activation than HCs, especially in sadness and fear, while MDDm showed stronger deactivation for all emotions than the other two groups.

Conclusions

We could show that emotion experience was associated with bodily sensations that are weaker in depression than in healthy controls and that antidepressant medication was correlated with an increased feeling of bodily deactivation. Results give insights into the relevance for clinicians to acknowledge bodily sensations in the treatment of depression.
Re-investigation of the Normal Spectral Emissivity at 684.5 nm of Solid and Liquid Molybdenum
Authors: Eber Alexander , Pichler Peter , Pottlacher Gernot
Published: December 2020

In this work, we present normal spectral emissivity data of solid and liquid molybdenum at a wavelength of 684.5 nm. The presented results are novel measurements on molybdenum, a material, which was already measured 15 years ago by our group. The present results indicate a lower emissivity in the liquid phase. The novel measurements were done within the European Metrology Programme for Innovation and Research (EMPIR) project 17IND11 Hi-TRACE. The optimized measuring system is an ohmic pulse-heating apparatus combined with microsecond Division of Amplitude polarimetry.
High-Temperature Oxidation of NiAlCr–Ca and NiAlCr–Sr Alloys in Air
Authors: Azakli Yunus , Gunduz Kerem Ozgur , Cengiz Sezgin , Gencer Yucel , Tarakci Mehmet
Published: December 2020

In this study, interrupted oxidation behavior of synthetic NiAlCr–Ca (Ca = 0.3, 1.4, 2 at.%) and NiAlCr–Sr (Sr = 0.4 at.%) alloys in the air at 1027 °C for 192 h was investigated. Parabolic rate constants (kp) showed that the Sr-containing alloy exhibited the best oxidation resistance among the alloys investigated in this study. The oxide scale formed on the Sr-containing alloy was composed of α-Al2O3 phase with Sr-rich nodules. Increasing the Ca concentration in the alloys was found to reduce the oxidation resistance due to the formation of non-protective Ca-rich complex oxides and consumption of α-Al2O3 scale by the reaction between Al2O3 and CaO. The Ca-rich complex oxides were initially formed on the Ca-rich interdendritic region and grew with time. Very little scale spallation was observed for the Sr-containing alloy, while it was notable for 0.3 at.% Ca-containing alloy. Spallation was attributed to the coefficient of thermal expansion (CTE) mismatch arisen from the formation of CaAl4O7 phase, a compound with a very low CTE.
Analysis of the developing gut microbiota in young dairy calves—impact of colostrum microbiota and gut disturbances
Authors: Hang Bui Phan Thu , Wredle Ewa , Dicksved Johan
Published: December 2020

The aim of this study was to characterize the colostrum and fecal microbiota in calves and to investigate whether fecal microbiota composition was related to colostrum microbiota or factors associated with calf health. Colostrum samples were collected in buckets after hand milking of 76 calving cows from 38 smallholder dairy farms. Fecal samples were taken directly from the rectum of 76 calves at birth and at 14 days age. The bacterial community structure in colostrum and feces was analyzed by terminal restriction fragment length polymorphism for all samples, and the microbial composition was determined by 16S rRNA gene amplicon sequencing for a subset of the samples (8 colostrum, 40 fecal samples). There was a significant difference in fecal microbiota composition between day 0 and day 14 samples, but no associations between the microbiota and average daily gain, birth weight, or transfer of passive immunity. At 14 days of age, Faecalibacterium and Butyricicoccus were prevalent in higher relative abundances in the gut of healthy calves compared to calves with diarrhea that had been treated with antimicrobials. Colostrum showed great variation in composition of microbiota but no association to fecal microbiota. This study provides the first insights into the composition of colostrum and fecal microbiota of young dairy calves in southern Vietnam and can form the basis for future more detailed studies.
Correction to: Ambitious subsidy reform by the WTO presents opportunities for ocean health restoration
Authors: Costello Christopher , Millage Katherine , Eisenbarth Sabrina , Galarza Elsa , Ishimura Gakushi , Rubino Laura Lea , Saccomanno Vienna , Sumaila U. Rashid , Strauss Kent
Published: December 2020

The original article can be found online.
What Do Migrants Know About Their Childcare Rights? A First Exploration in West Germany
Authors: Seibel Verena
Published: December 2020

Although an increasing number of studies emphasise migrants’ lack of knowledge about their childcare rights as a crucial barrier to their childcare usage, almost none examines the conditions under which migrant families acquire this knowledge. This study contributes to the literature by exploring potential individual factors determining migrant families’ knowledge about their childcare rights in Germany. I use unique data collected through the project Migrants’ Welfare State Attitudes (MIFARE), in which nine different migrant groups in Germany were surveyed about their relation to the welfare state, including childcare. Analysing a total sample of 623 migrants living with children in their household and by using logistic regression analyses, I find that human and social capital play significant roles in explaining migrants’ knowledge about their childcare rights. Migrants who speak the host language sufficiently are more likely to know about their childcare rights; however, it does not matter whether migrants are lower or higher educated. Moreover, I observe that migrants benefit from their co-ethnic relations only if childcare usage is high among their ethnic group. Based on these results, policy recommendations are discussed in order to increase migrants’ knowledge about their childcare rights in Germany.
The Football Association Injury and Illness Surveillance Study: The Incidence, Burden and Severity of Injuries and Illness in Men’s and Women’s International Football
Authors: Sprouse Bradley , Alty Jon , Kemp Steve , Cowie Charlotte , Mehta Ritan , Tang Alicia , Morris John , Cooper Simon , Varley Ian
Published: December 2020

Objectives

To determine the incidence and characteristics of injury and illness in English men’s and women’s senior and youth international football.

Methods

Time-loss injuries and illnesses, alongside match and training exposure, were collected across 8 seasons (2012–2020) in youth (U15, U16, U17, U18, U19) and senior (U20, U21, U23, senior) English men’s and women’s international teams. Analysis of incidence, burden, and severity of injury and illness was completed. Sex-specific comparisons were made between the senior and youth groups, and across the 8 seasons of data collection.

Results

In men’s international football, 535 injuries were recorded (216 senior; 319 youth) during 73,326 h of exposure. Overall, match injury incidence (31.1 ± 10.8 injuries/1000 h) and burden (454.0 ± 195.9 d absent/1000 h) were greater than training injury incidence (4.0 ± 1.0 injuries/1000 h) and burden (51.0 ± 21.8 d absent/1000 h) (both P < 0.001). In women’s international football, 503 injuries were recorded (senior: 177; youth: 326) during 80,766 h of exposure and match injury incidence (27.6 ± 11.3 injuries/1000 h) and burden (506.7 ± 350.2 days absent/1000 h) were greater than training injury incidence (5.1 ± 1.8 injuries/1000 h) and burden (87.6 ± 32.8 days absent/1000 h) (both P < 0.001). In women’s international football, a group × season interaction was observed for training injury incidence (P = 0.021), with the senior group recording a greater training injury incidence during the 2015–2016 season compared to the youth group (14.4 vs 5.7 injuries/1000 h; P = 0.022). There was no difference in injury severity between match and training for men’s (P = 0.965) and women’s (P = 0.064) international football.

Conclusions

The findings provide a comprehensive examination of injury and illness in English men’s and women’s senior and youth international football. Practitioners will be able to benchmark their team’s injury and illness incidence and characteristics to the match-play and training information provided in the present study.
SHARĪʿA AS STATE LAW: AN ANALYSIS OF ʿALLĀL AL-FĀSĪ’S CONCEPT OF THE OBJECTIVES OF ISLAMIC LAW
Authors: Tajdin Mustapha
Published: December 2020

This article presents and evaluates the legal thought of Muhammad ʿAllāl al-Fāsī (1910–1974) with a focus on his discourse on the objectives of Sharīʿa and the motives behind his reformulation of these objectives within the broader context of his political agenda. Al-Fāsī's concerns were not purely academic. As a political leader who struggled for the independence of his country and as a decision maker within the newly established Moroccan state, his theorization of Islamic law departed from traditional and modern efforts to negotiate the supposed status of Sharīʿa within the institutional structures of postcolonial Muslim states. The questions engaged in this article are to what extent did al-Fāsī's contribution to Maqāṣid go beyond its classical reformulations as represented by the Andalusian Māliki jurist Ibrāhīm Ibn Mūsā Abū Isḥāq al-Shāṭibī (d. AH 790/1388 CE) in his seminal work, Al-Muwāfaqāt fī Uṣūl al-Sharīʿa, and whether al-Fāsī's work represents a turn in the field of Maqāṣid when compared with that of other modern Muslim jurists, among them Muhammad al-Ṭāhir Ibn ʿĀshūr (1886–1970). This article focuses on al-Fāsī's book on Maqāṣid al-Sharīʿa, Maqāṣid al-Sharīʿa al-Islāmiyya wa Makārimuhā, and its contribution to the ongoing efforts to accommodate Islamic law within the corpus of modern secular laws.
Effects of substitution dietary guidelines targeted at prevention of IHD on dietary intake and risk factors in middle-aged Danish adults: the Diet and Prevention of Ischemic Heart Disease: a Translational Approach (DIPI) randomised controlled trial
Authors: Gotfredsen Johanne Louise , Hoppe Camilla , Andersen Rikke , Andersen Elisabeth Wreford , Landberg Rikard , Overvad Kim , Tetens Inge
Published: December 2020

The objective was to investigate the effects of substitution (SUB) dietary guidelines (DG) targeted at the prevention of IHD on dietary intake and IHD risk factors in Danish adults with minimum one self-assessed IHD risk factor. A 6-month single-blinded parallel randomised controlled trial with a follow-up at month 12 included 219 subjects (median age 51 years, 59 % female, 73 % overweight or obese) randomised into an SUB DG, an official (OFF) DG or a control group following their habitual diet (HAB). Participants in the DG intervention groups received bi-weekly reminders of their DG and recipes for dishes and the HAB group received a greeting. Dietary intake and fasting blood, anthropometric and blood pressure measurements were obtained at baseline, month 6 and month 12. Linear regression analyses were applied. At month 6, when compared with the HAB, the SUB had a greater impact on the extent of dietary changes with increased intake of whole grains, dietary fibre and low fibre vegetables compared with the OFF DG, and both DG groups had similar decreased percentage of energy (E%) intake from SFA. The extent of dietary changes was similar at month 12. No overall significant changes from baseline were found in blood pressure, anthropometrics and IHD risk markers. In conclusion, both SUB and OFF DG resulted in cardioprotective dietary changes. However, neither the SUB nor the OFF DG resulted in any overall effects on the selected intermediate risk factors for IHD.
Effects of maternal and post-weaned rumen-protected folic acid supplementation on slaughter performance and meat quality in offspring lambs
Authors: Li H.Q. , Wang B. , Li Z. , Luo H.L. , Zhang C. , Jian L.Y. , Gao Y.F. , Lu W. , Zhao X.G.
Published: December 2020

The present study was undertaken to evaluate the influence of rumen-protected folic acid (RPFA) on slaughter performance, visceral organ and gastrointestinal tract coefficients, and meat quality in lambs. Sixty-six lambs from 120Huewes were selected based on body weight and maternal diets and then assigned to six groups using a randomised block experimental design in a 3 × 2 factorial arrangement. The first factor was folic acid (FA) as RPFA in the maternal diet (0 mg/kg (M0F), 16 mg/kg (M16F) or 32 mg/kg (M32F) on DM basis). The second factor was FA in the lambs’ diet from weaning until slaughter (0 mg/kg (OC) or 4·0 mg/kg (OF)). The results indicated that the addition of 16 mg/kg FA to the maternal diet increased pre-slaughter weight (PSW), dressing and meat percentage, the reticulum and omasum coefficients, length of the jejunum and ileum, tail fat and perirenal fat coefficient anda* value of the meat colour. The addition of RPFA to the lambs’ diet increased PSW, dressing and meat percentage, eye muscle area, abomasum weight, weight and length of the small intestine, but reduced the coefficients of tail fat. An M × O interaction was observed for the weights of heart, lungs, rumen and total stomach, weight and coefficient of omental fat and the girth rib value. Collectively, RPFA in the maternal and lambs’ diet improved slaughter performance and meat quality by stimulating the morphological development of the gastrointestinal tract and the distribution of fat in the body.
OP141 Health Technology Assessment In India: Current Scenario And Way Forward
Authors: Shah Komal , Saha Somen , Kotwani Priya , Singh Malkeet , Tyagi Kirti
Published: December 2020

Introduction

India has introduced health technology assessment (HTA) as a tool for improving the allocation of health resources. The core mandate of HTA in India (HTAIn) is to undertake critical appraisal of available technologies, identify cost-effective interventions, and help the government pursue evidence-informed decisions regarding public health expenditures. We conducted a systematic review to assess economic evaluation studies published in the last four years from India.

Methods

Economic evaluations published from September 2015 to September 2019 were identified by searching various databases, including PubMed, Scopus, Embase, The Cochrane Library, and CINAHL according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Cost-effectiveness studies and HTAs reported or conducted in India were included. Two independent reviewers performed the final selection of studies by assessing the full-text articles and conducted the data extraction. Differences of opinions were resolved through discussion and mutual consensus.

Results

After screening 2,837 articles, seventy met the inclusion criteria and were selected. The articles predominantly used secondary data (70%) to evaluate the cost effectiveness of an innovation. Among the technologies assessed, fifty-seven percent were curative in nature and most commonly addressed infectious diseases (27%), closely followed by non-communicable diseases, and maternal and child health. Principally, the cost effectiveness of a technology was expressed in terms of disability-adjusted or quality-adjusted life-years. Only two studies reported negative findings.

Conclusions

HTA can play a pivotal role in equipping policy makers and public health payers to make appropriate decisions for healthcare budget allocations when mapped with the true disease burden of the population. It is important to highlight negative results and to create a national repository of HTA studies to facilitate faster adoption of best practices in India.
OP145 Review Of eHealth Interventions For Improving Primary Healthcare In Low-Middle Income Countries
Authors: Pandya Apurvakumar , Raval Devang , Kotwani Priya , Saha Somen
Published: December 2020

Introduction

Web-based and mobile health interventions, also called eHealth, have significant potential to deliver cost effective, quality health care. The present review maps common eHealth technology solutions for primary healthcare by evaluating their safety, efficacy, and effectiveness, and the challenges associated with their implementation in low-middle income countries (LMIC) in the last ten years.

Methods

A search of various electronic database was conducted, including PubMed, Scopus, and PsycINFO, to identify articles published between 2009 and 2019 that focused on the implementation of eHealth in the primary healthcare setting across LMICs. A total of 450 articles were screened and thirty-nine relevant articles were selected for review.

Results

The thirty-nine included studies were classified into the following four categories: (i) assessment of intervention effects (n = 26); (ii) cost-benefit analysis (n = 4); (iii) systematic review (n = 5); and (iv) conceptual exploration of eHealth interventions (n = 4). The eHealth studies covered three domains: (i) non-communicable diseases; (ii) reproductive, maternal, newborn, and child health; and (iii) other health issues. The included eHealth technologies comprised mobile health (n = 27), telemedicine (n = 10), and information and communication technology (n = 2).

Conclusions

The majority of studies assessed eHealth technologies based on the following eight dimensions: safety, clinical effectiveness, technical aspects, acceptability, cost, ethical aspects, adaptability to local needs, and scalability. However, evidence on safety, cost effectiveness, and scalability were limited. The main implementation challenges identified were technology development and maintenance costs, the need for trained human resources, and acceptability among users. The methodologies and assessment frameworks of the studies were heterogeneous in nature, highlighting the need for a robust, standardized, and comprehensive framework for assessing eHealth technologies.
OP184 Strengthening Patient Outcome Evidence In Health Technology Assessments: A Co-Production Approach
Authors: Rasburn Mark , Livingstone Heidi , Leng Gillian
Published: December 2020

Introduction

Involving patients is a core principle which governs the work of the National Institute for Health and Care Excellence (NICE). To improve how patient evidence is identified and considered in health technology assessments (HTAs), NICE worked with patient organizations to review existing HTA methods and co-designed proposals for change.

Methods

A working group, including six patient organizations, oversaw the project, identifying and co-designing options for improvement. We held a stakeholder event with twenty-two patient organizations to identify themes for improving how we find and use patient evidence. We then ran an online quantitative and qualitative survey for targeted consultation with patient organizations to capture broader views.

Results

The fifty-two people who responded to the consultation made the following suggestions:

(i)

Provide information about uncertainties that patient evidence might help to address;

(ii)

Explore the role of real-world evidence in patient involvement;

(iii)

Provide training and support to patient organizations;

(iv)

Create inclusive committee cultures; and

(v)

Include additional touchpoints during HTAs to incorporate patient evidence.

Conclusions

This work identified improvements in seeking and incorporating patient evidence into HTA processes. Precise guidance for patient organizations will help them to submit evidence that will make the most impact. This is particularly important when assessing disruptive technologies where there are likely to be greater uncertainties and cost pressures. The results of this work will be developed into formal options for NICE to consider when updating its methods guides.
OP230 How Legitimate Is The Process Of Updating the Benefits Package In Israel? A 20 Year Overview
Authors: Greenberg Dan , Assor Yael
Published: December 2020

Introduction

The National Health Insurance Law enacted in 1995 stipulates a minimum list of health services (benefits package) that the four health plans in Israel have to provide to their members. The recommendations on which new technologies or new indications for existing ones should be added every year to the benefits package, subject to a predetermined budget, are made by a public committee that evaluates and prioritizes candidate technologies according to their clinical merit, economic (mainly budget impact), social, ethical and other aspects. We assessed the legitimacy of this coverage decision process over the past 20 years.

Methods

The legitimacy of the process was assessed by adherence to the conditions outlined in the accountability for reasonableness (A4R) framework. A4R defines four conditions for legitimate and fair healthcare coverage decision processes: relevance, publicity, appeals/reversibility, and enforcement. We reviewed the changes made in the coverage decision process over the past 20 years and examined whether these changes have changed its legitimacy.

Results

Our analysis suggests that despite several changes made over the years in the process for updating the benefits package, for example, increase in transparency, introducing a structured appeal process, it only partially fulfills the four A4R conditions. In order to accomplish these goals more fully, several widely used considerations such as cost-effectiveness analysis and incorporating views from patients should be included. Additionally, this decision-making process should become even more transparent than it currently is.

Conclusions

The annual process of updating the benefits package in Israel where hundreds of technologies are “competing” with each other for coverage under a pre-defined budget is unique and not without merit. This process has been operating in the same pattern with only minor changes made since 1999. The main barriers for fulfilling all A4R conditions may relate in part to the large number of technologies assessed each year within a short time frame. Several changes in the process including the assessment of societal values, involvement of diverse stakeholders including patient advocate groups should be made to improve its legitimacy.
OP340 Adverse Clinical Events And Associated Risk Factors In Patients With Very-High-Risk Atherosclerotic Cardiovascular Disease
Authors: Zhao Boya , He Xiaoning , Zhao Jia , Wu Jing
Published: December 2020

Introduction

Clinical atherosclerotic cardiovascular disease (ASCVD) patients are judged to be very-high-risk if they had a history of multiple major ASCVD events, or one major ASCVD event with multiple high-risk conditions. Very-high-risk ASCVD patients are under high risk of adverse clinical events and need more attention in the management of secondary prevention. This real-world study aimed at estimating the prevalence of very-high-risk ASCVD and investigating the occurrence of adverse clinical events and associated risk factors among patients with very-high-risk ASCVD in China.

Methods

Data were obtained from the Urban Employee Basic Medical Insurance database in Tianjin, China. Very-high-risk ASCVD patients were identified from 2014 to 2015 through the history of ASCVD events and evidence of high-risk conditions, and followed for 24 months. Adverse clinical events were measured by major adverse cardiovascular events (MACE), a composite endpoint of stroke, myocardial infarction (MI) and death. A Cox regression model was used to identify risk factors of MACE, adjusting for potential confounders.

Results

The percentage of clinical ASCVD patients identified as very-high-risk was 35.2 (N = 41,181), while 34,740 patients with continuous enrollment were included (mean age: 67.1 years; 42.5% female). The percentage of patients who had MACE in the 24-month follow-up period was 27.7, with stroke (22.3%) as the most prevalent event followed by death (6.9%) and MI (1.3%). Male gender, older age, and having MI or ischemic stroke (versus unstable angina) as the index major ASCVD event were risk predictors of MACE.

Conclusions

More than one-third of patients with clinical ASCVD are under very-high-risk in China, and among them 27.7 percent experience MACE during a 24-month follow-up period. Male patients, older patients, and patients who had MI or ischemic stroke are under higher risk of experiencing MACE. Future studies are warranted for comparing the differences in characteristics, pattern of drug use, occurrence of adverse clinical events and medical burden between very-high-risk ASCVD patients and ASCVD patients not at very-high-risk.
OP484 Analysis Of Horizon Scanning Outputs For The National Institute for Health and Care Excellence Health Technology Assessment Process
Authors: Khan Sarah Khalid , Moral Sonia Garcia Gonzalez , Ogunbayo Dapo , Craig Dawn
Published: December 2020

Introduction

The National Institute for Health Research (NIHR) Innovation Observatory (NIHRIO) is the national Horizon Scanning (HS) organization in England, and the National Institute for Health and Care Excellence (NICE) is its key health technology assessment (HTA) stakeholder. NIHRIO has a remit to notify NICE of innovative technologies with a time horizon of three years prior to regulatory approval in the European Union (EU)/United Kingdom (UK). The notification process produces an initial ‘filtration form’ followed by a ‘technology briefing’ produced 17–20 months prior to licence for those technologies that NICE will consider for appraisal. Since April 2017, NIHRIO has produced ~400 technology briefings. We present an analysis of how this has fed into the NICE HTA process so far.

Methods

The analysis mapped NIHRIO's technology briefings (April 2017 – June 2020) with relevant NICE technology appraisal/highly specialized technologies (TA/HST) guidance during the time period. The analysis followed the timeline of technologies from identification during the horizon scanning process to filtration to briefing submission to NICE and entering the TA/HST process to outcome/recommendation given by NICE.

Results

Until June 2020, 496 technology briefings entered the NICE TA/HST scoping process. Forty per cent are in progress, four per cent have had a TA/HST recommendation and three per cent that entered the NICE TA/HST scoping process did not complete it. On average it took less time from briefing submission to NICE recommendation for cancer indications. The time from discovery to NICE recommendation ranged from 115 months to 22 months.

Conclusions

HS for TA/HST is a lengthy process from identification to final recommendation and there is considerable variation in time duration from identification to briefing submission to NICE recommendation. Average time taken from briefing submission to NICE recommendation is shorter for cancer indications and repurposed medicines. A full TA/HST may not be recommended for all technology briefings, rather they may update existing guidance or find different routes of evaluation. Technologies that enter the TA/HST scoping process might be terminated, suspended or discontinued for several reasons which may include lack of company engagement, change in development or regulatory plans by the company. Timely notification is key in achieving TA/HST recommendation at the time of market authorization but not the only influencing factor.
OP523 Towards A Health Technology Assessment Framework For Omics-Technologies: Preliminary Results Of The ExACT project.
Authors: Govaerts Laurenz , Hoxhaj Ilda , Simoens Steven , Dyck Walter Van , Huys Isabelle , Boccia Stefania , Gutierrez-Ibarluzea Inaki
Published: December 2020

Introduction

Omics technologies enable the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics) and thus proved to be valuable tools for personalized decision-making in clinical practice. For their evaluation, a health technology assessment (HTA) framework is not standardized and accepted, yet. Therefore, we aim at designing an omics-technologies HTA evaluation framework to facilitate their assessment, through a mixed-method approach. This work is part of the ExACT project, which aims to produce a range of tools to facilitate the implementation of precision health in clinical practice.

Methods

A systematic review was conducted to identify the existing HTA frameworks used for the evaluation of omics-technologies. Desk research on the HTA agencies’ websites was performed to identify the reports on omics-technologies HTA evaluation frameworks used by these agencies. A questionnaire evaluating HTA agencies’ experience on evaluation of omics-technologies was designed. The new framework will be elaborated based on the findings from the three methodological steps, and will be validated through a Delphi process.

Results

Twenty-three articles were included in the systematic review. The main identified HTA frameworks were ACCE and “Evaluation of Genomic Applications in Practice and Prevention” (EGAPP). The desk research showed that these frameworks were seldom used by HTA agencies, which for the evaluation of omics-technologies mostly refer to the HTA Core Model®, mainly assessing the following domains: clinical effectiveness and economic evaluation. Data collection process of the questionnaire HTA agencies’ experience is in progress.

Conclusions

Although two main HTA frameworks for the evaluation of omics-technologies have been identified, these frameworks are sporadically used by HTA agencies in their practice. The particular interest of HTA agencies on clinical effectiveness and economic evaluation, might potentially reflect the uncertainty and difficulties when evaluating omics-technologies. This could indicate that these HTA frameworks are not feasible and practical to be used in routine HTA agency processes for omics technologies, emphasizing the need for a new framework. Our methodological approach might contribute to the development of a new HTA framework, feasible and practical to use not only for HTA agencies.
OP544 Appraising Variation In Health Technology Assessment Of Novel Immuno-Oncology Medicines In Australia, Canada, France, And The United Kingdom
Authors: McCann Eilish , Goto Daisuke , Griffiths Jessica , Hollywood Alicia , Spiteri Carmel
Published: December 2020

Introduction

Demonstrating the value of medicines through health technology assessment (HTA) systems is becoming increasingly complex. Innovative therapies – such as immuno-oncology (IO) agents – are testing limits of methodological approaches in markets with established HTA systems. The objective of this study is to understand how requirements, approaches, and decision-making differ between select HTA agencies with a focus on specific PD-1/PD-L1 (programmed death receptor-1/programmed death-ligand 1) agents and cancer indications, and to describe how this variation impacts patient access. To achieve this objective, we conducted a detailed HTA dossier review for several recently launched IO products across Australia (AU), Canada (CA), France (FR), and the United Kingdom (UK).

Methods

Content experts reviewed HTA dossiers for pembrolizumab, nivolumab, and atezolizumab for non-small cell lung cancer (NSCLC) first-line monotherapy, NSCLC combination therapy, and adjuvant melanoma. A systematic analytic framework was developed to understand best-practice methodology across systems. Information on submitted data, patient/expert input, and access decisions were extracted; key themes were identified and refined through workshop discussion, and probed further through blinded primary research with eight individuals with current or recent experience of HTA systems.

Results

We identified six major elements of variation impacting decision-making: evidentiary expectations for biomarkers, use/impact of patient-centered data; use/impact of real-world data, acceptance of surrogate endpoints, approaches for clinical data extrapolation, and accepted time horizons. Considerable variation in time to access was observed; for pembrolizumab (NSCLC first-line monotherapy), time from product registration to HTA decision ranged from 42 (CA) to 487 (AU) days; time from registration to listing ranged from 189 (CA) to 605 (AU) days.

Conclusions

Evaluated HTA systems demonstrate a large degree of variability in approaches to decision-making for novel IO medicines; resultant access decisions and time to access are also highly variable. Inconsistency between systems and duplication of effort when assessing similar clinical/economic data could be contributing to limited or delayed patient access; the relationship merits further exploration. Assessed HTA systems are currently undergoing process revisions but expert input suggests that this is not expected to reduce variation, and could further increase complexity. The influence of parallel scientific advice programs between HTA agencies and regulatory bodies in reducing variation must also be determined.
PP146 Cost Effectiveness Of Aripiprazole Orally Disintegrating Tablets For The Treatment Of Schizophrenia In China
Authors: Lin Ziyi , Xuan Jianwei
Published: December 2020

Introduction

Although antipsychotic medications have been a cornerstone in the treatment of schizophrenia for decades worldwide, the orally disintegrating tablet (ODT) formulation is a new concept in China. Only four brand names exist in the Chinese market, three of which were launched recently. Patients taking ODTs have a higher rate of medication adherence and consequently experience better treatment outcomes than patients taking the same medication in standard oral tablet (SOT) formulation. This study aimed to analyze the cost effectiveness in China of aripiprazole in ODT form, compared with the SOT forms of aripiprazole and olanzapine.

Methods

A discrete-event simulation model was built to represent the one-year progression of schizophrenia. On entry into the model, 100,000 people for each treatment arm were labeled fully adherent, partially adherent, or non-adherent based on medication possession ratios, and then experienced events including relapse, adverse events, changing adherence levels, and treatment switching and quitting. Parameters for adherence rates, medical costs, and utility values were derived from the published literature. The switching pattern was acquired through interviews with fifty-seven Chinese psychiatrists.

Results

The total annual costs per patient in the aripiprazole-ODT, aripiprazole-SOT, and olanzapine-SOT arms were CNY 9,817 (USD 1,388), CNY 15,278 (USD 2,160), and CNY 10,298 (USD 1,456), respectively. The annual quality-adjusted life-years (QALYs) gained per patient in the aripiprazole-ODT, aripiprazole-SOT, and olanzapine-SOT arms were 0.73, 0.71, and 0.72, respectively. According to the probabilistic sensitivity analysis, the probability of aripiprazole-ODT being cost effective was ninety-nine percent, when compared with aripiprazole-SOT and sixty-nine percent when compared with olanzapine-SOT.

Conclusions

Aripiprazole-ODT was associated with lower costs and higher gains in QALYs than either aripiprazole-SOT or olanzapine-SOT in patients with schizophrenia in China. While the sensitivity analysis confirmed the robustness of the result that aripiprazole-ODT was better economic value than aripiprazole-SOT, there is some uncertainty in the comparison between aripiprazole-ODT and olanzapine-SOT. The main limitation of this study is that some parameters were sourced from studies on Western populations because of a lack of data in China. Local data on the use of antipsychotics, especially adherence rates, is needed.
PP162 Digital Medication Health Service Platforms Of Pharmaceutical Companies As Novel Sources Of Real-World Data For Health Technology Assessment
Authors: Li Jian , Wang He , Ung Carolina Oi Lam , Hu Hao
Published: December 2020

Introduction

Digital medication health service (DMHS) platforms are increasingly used by pharmaceutical companies to provide direct medication health services through digital methods like apps, hotlines, and web services, etcetera. However, the implications of such platforms in supporting health technology assessment (HTA) are rarely discussed in the literature. This presentation sets out the opportunities for using the DMHS platforms of pharmaceutical companies as real-world data sources for HTA.

Methods

A mixed-method qualitative study combining literature review and case study was conducted. Relevant literature was identified by searching the Web of Science and PubMed databases. A case study on current DMHS platforms in China was carried out using an inductive approach to identify the key elements emerging from these platforms.

Results

DMHS platforms of pharmaceutical companies can identify multiple attributes of medication information needs regarding medical products, including effectiveness, safety, and economic factors. The platforms can respond to different stakeholders, including patients and their carers, doctors, nurses, pharmacists, etcetera. As one kind of interactive process, DMHS platforms can provide further services, including patient education, consultation, and evaluation, follow-up visits, chronic disease management, promotion of the rational use of drugs, therapeutic drug monitoring, and adverse drug reaction surveillance and reporting.

Conclusions

The DMHS platforms of pharmaceutical companies provide a unique and valuable real-world data source for HTA. These types of self-reported outcomes have not gained enough attention in HTA. Collective efforts by HTA agencies and pharmaceutical companies are needed to set strategies for integrating DMHS platforms into HTA.
PP194 Research On The Correlation Mechanism Between The Psychological Contract Of Physicians In Public Hospitals And Their Turnover Intention
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 turnover intention in Chinese public hospitals, as well as the moderating effects of variables such as sex, hospital level, working period, department, and reason for career choice on the correlation models.

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 transactional and developmental responsibility had a significant negative effect on the intent of physicians to leave the hospital and front-line clinical practice, respectively. Working pleasure, fairness perception, and occupational satisfaction were mediator variables in the impact. In addition, 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 transactional responsibility had a more negative effect on the intent of physicians to leave the hospital than other responsibilities, whereas fulfillment of hospital developmental responsibility had a more negative impact on the intent of physicians to leave front-line clinical practice. 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.
PP290 Exploratory Investigation On Innovative Business Models Of Internet Hospitals In China: A Focus Group Study Of Key Stakeholders
Authors: Hu Hao , Chen Shengqi , Li Meng , Ung Carolina Oi Lam , Lai Yunfeng
Published: December 2020

Introduction

Under the national guidance of Internet Plus Healthcare, Internet hospital was officially recognized in 2018 by the Chinese government, however, how to innovate the business models of Internet hospitals remains controversial. This study sought to explore key stakeholders’ perspectives on key dilemmas about innovative business models of Internet hospitals in China.

Methods

A focus group study of key stakeholders was performed. Twelve key stakeholders (six senior officials from related ministries, two industry practitioners of Internet medicine, one hospital leader, two healthcare researchers (financing and policy), and one venture capital manager) participated in the focus group, in 2019. Thematic content analysis was applied for data analysis.

Results

Themes highlighted six key dilemmas when developing a business model of Internet hospitals, including (i) value proposition (medical treatment versus entire health management); (ii) leading party (hospitals versus third parties such as Internet companies); (iii) level of healthcare (tertiary versus primary); (iv) scope of service (provide full range versus part of traditional hospital service); (v) primary source of revenue (medical services versus drug sales); and (vi) legal liability (web-based unit versus physical hospital).

Conclusions

The healthcare industry is currently in search of innovative business models of Internet hospitals in response to the unprecedented form of healthcare in China. However, the core aspects of the model design still remain debatable. At this revolutionary stage, policies are important to allow the implementation of different model designs that support the successful transformation of the entire health care system in China.
PP297 Rethinking The Gap Between Technology And Implementation: A Framework For Socially Embedded Technoscience
Authors: Andrews Chad
Published: December 2020

Introduction

In 1964, Jacques Ellul framed the history of technology as one defined not just by the introduction of new machines, but by the social and institutional practices that guide their use and implementation. He called this integrated system “la technique,” believing that the word “technology” had come to emphasize physical tools at the cost of social ones.

There is a strong critical component in Ellul, who opposed the dehumanization apparent in technological systems and their associated forms of utilitarian thinking. Remaining aware of this critical history, this study relies on Ellul and similar technological theories to conceptualize a framework for rethinking the distinction between health technologies and their implementation in the context of health technology assessments (HTAs). It does so by considering how HTAs could be modified within the proposed framework to better consider the social and human factors that determine how a drug or technology exists within a “live” social environment.

Methods

The study is conceptual and driven by an analysis of existing HTAs. It details potential ways that reviews could be adjusted in line with the presentation's proposed framework.

Results

By collapsing the distinction between technology and implementation, we can guide HTAs that are more cognizant of the essential human and social components of implementation, helping to avoid the crises that arise when technologies are introduced without considering their fundamental social factors.

Conclusions

Many modern HTAs already take implementation into account, but their findings treat technologies as conceptually distinct from practices and procedures, leaving the latter to local institutions to determine. By challenging the traditional gap between technological and sociological factors in traditional HTA practices, it is possible to develop new approaches to reviewing health technologies—not as distinct objects, but as complex sociotechnical phenomena in line with Ellul's “la technique.”
PP316 Efficacy And Usability Of eHealth Technologies In Stroke Survivors For Improvement Of Self-Management: Clinical Trial
Authors: Arri Eunate Arana , Ortiz-Fernández Leire , Orcajo Janire , Fernández Rubén García , Sagastagoya Joana , Imaz-Ayo Natale , Alava-Menica Ander
Published: December 2020

Introduction

Stroke is a leading cause of severe and long-term disability in developed countries. Around 15 million people suffer a stroke each year, most due to modifiable risk factors. Several reviews have shown that interventions mediating eHealth technologies can reduce the risk of suffering a stroke episode, improving the control of risk factors; nevertheless, all of them conclude that new and well-designed studies are needed.

Methods

We performed a prospective, randomized, parallel group and open, pilot trial. The study was carried out based on an initial sample of forty-three patients between 18 and 80 years old who have had an ischemic stroke. The control group got conventional treatment and the intervention group got conventional treatment and the assistance of STARR (the Decision SupporT and self-mAnagement system for stRoke survivoRs), as well as commercial wearables. The principal variable of the study was to evaluate the usability of the decision support system.

Results

At month nine, the average score on the System Usability Scale in the intervention group was 64.7 and in month 12, 67.4, exceeding in both cases the margin of acceptability (50) and in the limit of “good” (68). When we analyzed clinical factors (systolic/diastolic blood pressure) as well as the analytical parameters related to prevention of reinfarction, we observed that the intervention group had good control of blood pressure and better analytical parameters, compared to the control group.

Conclusions

Technological support allowed participants to feel comfortable using the devices as well as resolving technical incidences by themselves after a training period. The self-management platform can be efficient in stroke survivors’ management of their disease condition, improving analytical and clinical parameters, which eventually can influence a decrease in associated comorbidities and, therefore, improvement of the disease. However, it should be noted that this type of platform is not useful for every patient profile, and studies in this regard should be expanded.