bluuebunny/crossref_metadata_2025 huggingface dataset:
PP04 Supporting The Social Integration Of Persons With Brain Injury Using Psychoactive Substances: A Health Technology And Intervention Assessment
Authors: Maltais Christine , Djouini Akram , Messier Frédéric , Bélanger Karine , Lespérance Nadia , Deguise Élaine
Published: December 2022

Introduction

People with a traumatic brain injury and who present with an unsafe or problematic substance use of psychoactive substances (PAS) face specific challenges in social integration resulting from the negative impacts of substance use on the benefits of rehabilitation services and treatments.

Methods

A systematic review of grey and scientific literature was conducted. The selection and coding of the included interventions (according to their characteristics), as well as descriptive analyses, resulted in findings which describe the interventions under study. Grades of evidence strength were attributed to the findings based on a range of factors including the methodological characteristics of the studies. Findings resulting from the systematic review were contextualized with information collected from administrative databases, clinical program documentation, and experiential data obtained from rehabilitation professionals. Recommendations were elaborated based on the aggregated data sources and informal deliberations by a committee involving researchers and clinicians.

Results

Out of 5014 selected references, 14 studies examining 13 interventions which targeted social integration of the management of PAS were included. Interventions with the strongest evidence base are user-centered (i.e., support individual choices and personal autonomy), individualized (i.e., considered individual needs and characteristics), and educational (i.e., support the acquisition of strategies and abilities). The evidence base was considered “emerging” for interventions which are systemic in nature (i.e., relate to familial, social, cultural, educational or professional environments), interdisciplinary (i.e., involve clinicians with distinct training, competences and expertise), and ecological (i.e., which involve interventions in the client’s living settings). While additional research is necessary to better support their efficacy, these interventions exhibited promising effects on various outcomes.

Conclusions

The analysis and synthesis of three streams of information resulted in five clinical practice recommendations relating to integration to school and productive activities, psychological adaptation, integration in living settings and independence, social life and sense of belonging, and finally, use of PAS. Recommendations should help support clinicians in rehabilitation settings.
PP06 Clinical Effectiveness Of Fluticasone Furoate Nasal Spray For Perennial Allergic Rhinitis In Children: A Systematic Review And Meta-Analysis
Authors: Rivera Paola Andrea
Published: December 2022

Introduction

Although previous studies suggest that fluticasone furoate nasal spray (FFNS) is superior to placebo in reducing symptoms in adolescents and adults with allergic rhinitis (AR), there is still uncertainty about its clinical effectiveness in the pediatric population. The aim of this study was to assess the clinical effectiveness of FFNS, compared with placebo, in reducing nasal symptoms in children with perennial AR.

Methods

A systematic review was conducted of studies identified from the MEDLINE and Embase databases that were published up to January 2021. The population of interest was patients aged 2 to 12 years with perennial AR. Included studies were limited to randomized controlled trials (RCTs) comparing FFNS (110 μg once daily) with placebo. The outcomes of interest included the reflective Total Nasal Symptom Score (rTNSS) and safety. Meta-analyses were performed using RevMan 5.4. The Cohen’s guideline was used to assess the minimum clinically important difference for rTNSS; that is, if the pooled standardized mean difference (SMD) and the lower limit of the 95 percent confidence interval (CI) exceed -0.5, the treatment effect was considered clinically significant.

Results

Three RCTs (959 pediatric patients) were included. One study evaluated the short-term use of FFNS, one evaluated the long-term use of FFNS, and the third evaluated both the short- and long-term use of FFNS. FFNS produced a statistically significant reduction in rTNSS (SMD -0.35, 95% CI -0.63, -0.08; p<0.001) relative to placebo in the long-term treatment studies, but not in the short-term studies. However, since the mean reduction did not reach the minimum clinically important difference (SMD -0.5), these results were not considered clinically relevant. The safety outcomes for FFNS were similar to placebo.

Conclusions

The currently available evidence suggests that FFNS does not produce a meaningful clinical effect on nasal symptoms in children with perennial AR, compared with placebo. In the past decade, however, some guidelines have unequivocally endorsed this treatment.
PP07 Improving The Use Of Real-World Evidence In The Development Of NICE Guidance
Authors: Kent Seamus , Duffield Stephen , Rowark Shaun , Kincaid Lynne , Gupta Vandana , Sharma Manuj , Jonsson Pall
Published: December 2022

Introduction

The National Institute for Health and Care Excellence (NICE) is determined to make better use of health and social care data in the development of its guidance. Real-world data (RWD) has the potential to significantly improve our understanding of the value of new and existing health and social care interventions. RWD is already widely used to characterize populations, interventions, and outcomes and to populate economic models, but its use in estimating the effects of interventions remains limited, especially for medicines. Key barriers to its greater use in this context include limited transparency around studies, sometimes a lack of confidence in their integrity, and methodological concerns around how studies have addressed major sources of potential bias.

Methods

This abstract focuses on the real-world evidence (RWE) framework developed by NICE to support its ambitions. The framework was developed in an iterative way based on: reviews of best practice approaches to the conduct and assessment of real-world evidence studies; case studies; and workshops with key external stakeholders. The initial version of this living framework focuses on de novo RWE studies using individual patient data.

Results

The RWE framework consists of an overarching research governance framework which describes expectations around the planning, conduct, and reporting of RWE studies across uses of real-world data. Uses are categorized by risk according to their importance to decision-making, the impact of decisions on patient and system outcomes, and their complexity as proxied by risk of bias. Studies of the effects of interventions on patient health and system outcomes are considered the highest risk. The research governance framework is supported by a tool to aid assessment of data suitability for its intended application, and detailed guidance on the conduct and reporting of comparative effect studies using RWD, following the target trial approach.

Conclusions

The RWE Framework underpins NICE’s ambitions to make better use of RWD in its guidance and is intended to improve the quality and utility of RWE studies submitted to NICE enabling more consistent and appropriate evaluation.
PP08 Evaluation Of Nutritional Status In Diabetic And Non-Diabetic Chronic Kidney Disease Patients Using A Web Tool
Authors: Rashid Ishfaq , Tiwari Pramil , D’Cruz Sanjay , Jaswal Shivani
Published: December 2022

Introduction

Poor nutritional status, a complex consequence of numerous interrelated factors, is poorly characterized in patients with chronic kidney disease (CKD) before they commence dialysis. This study aimed to characterize the risk factors and prevalence of malnutrition among patients with CKD, with or without diabetes mellitus, before they underwent dialysis at a tertiary care public teaching hospital.

Methods

This longitudinal observational study utilized a Pt-Global web tool© to assess the nutritional status of patients based on their Subjective Global Assessment score as follows: a score of two to three indicates that patient and family education is required; scores of four to eight mean that intervention is required as indicated by symptoms; and a score of nine or more indicates a critical need for intervention. Glomerular filtration rate calculated using the Chronic Kidney Disease Epidemiology Collaboration equation was used as the measure of kidney function. Multinomial regression analyses were used to ascertain the predictors of poor nutritional status.

Results

A total of 450 patients (265 men and 185 women) who had CKD, with or without diabetes, and were not on dialysis were recruited during the period of study. The average age of the patients was 53.9 years (standard deviation 14.2). ‘Severe’ malnutrition was present in 152 (33.8%) patients, while 140 (31.1%) were ‘mildly or moderately’ malnourished, and 158 (35.1%) were ‘well-nourished’. Patients with CKD and diabetes were more severely malnourished: 68 were rated as mild or moderate (15.1%) and 91 were rated as severe (20.2%). The prevalence of malnutrition increased with the decline of residual renal function. Fatigue, loss of appetite, pain anywhere in the body, constipation, dry mouth, feeling full quickly, and physical and functional inactivity were the most common risk factors for poor nutritional status.

Conclusions

This study presents real-world evidence of poor nutritional status in patients with CKD and confirms that it is more common in individuals who are diabetic and have poor kidney function and hypoalbuminemia. Emphasis on nutrition in patients with CKD is important for improving their health.
PP09 Use Of Real-World Evidence For Managing Health Technologies Throughout The Life Cycle Of Transcatheter Aortic Valve Interventions
Authors: de Verteuil Danielle , Azzi Leila , Lambert Laurie , Boothroyd Lucy , Duranceau Marie-France , Pagé Élisabeth , Truchon Catherine
Published: December 2022

Introduction

A Cardiology Evaluation Unit was established in 2004 within Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) with a novel mandate to collect real-world evidence (RWE) to complement literature-based health technology assessment. In 2010 following publication of the seminal PARTNER trial, INESSS was mandated by the health ministry to review the evidence on transcatheter aortic valve intervention (TAVI) for patients with aortic stenosis. Herein we show how RWE was used to evaluate health system performance throughout the technology’s life cycle and inform organizational and clinical decisions.

Methods

Various products were diffused by INESSS over the years: a guidance (2012), an updated literature review (2017) and provincial standards (2017), in parallel with RWE reports covering TAVI use from 2013-2015, from 2013-2018, and a 2021 RWE report combined with administrative data covering transcatheter and surgical treatment of aortic stenosis from 2013-2019.

Results

Based on the guidance’s review of evidence, TAVI was initially recommended for patients considered at too high risk for the surgical approach, under the condition of continued evidence generation to address uncertainty. The subsequent literature review update highlighted that the indication for TAVI had been extended to patients at moderate surgical risk. INESSS produced standards in collaboration with clinical experts to optimize and harmonize the use of TAVI in designated centers. Evaluation of structures, processes and outcomes by INESSS continued until 2019, showing a continuous increase in the use of TAVI, improved short-term survival, and careful patient selection via a multidisciplinary process. RWE also highlighted the impact of TAVI on the overall organization of care for patients with aortic stenosis, as selection criteria further expanded to patients at lower surgical risk, raising important issues regarding patient selection processes, wait times, and longer-term outcomes.

Conclusions

TAVI clinical practice is constantly evolving and leads to changes in the management of aortic stenosis. RWE provided essential organizational and clinical input to inform clinical guidance and decision-making by Québec policy-makers, clinicians and patients.
PP16 Machine Learning In The Treatment Of Spinal Deformities: Early Life-cycle Economic Analysis In Australia
Authors: Joglekar Rashmi , Shikule Aaron
Published: December 2022

Introduction

Patients with spinal deformity require implanted spinal rods to be specifically shaped to their anatomy. Spinal rods which are manually shaped in the operating theatre are prone to fracture and malpositioning. This emphasizes the need for preoperative planning, intraoperative imaging, and accurate shaping of the implant. The application of machine learning (ML) has enabled precision in shaping patient-specific rods, with the potential to reduce adverse events. Our objective is to assess the economic value of this technology, early in its lifecycle, in the context of Health Technology Assessment (HTA) in Australia.

Methods

A budget impact analysis was performed to quantify the economic value of patient-specific spinal rods from an Australian payor perspective. Clinical outcomes were sourced from literature review, and cost inputs were obtained from Medicare, Private Health Data Bureau and Hospital Casemix Protocol Data databases.

Results

Preliminary analysis indicates that a reduction in the rate of revision surgery due to decreased instrument failure results in cost-savings to the healthcare system, despite a higher outlay for the patient-specific rods. Adolescents who may have remained sagittally malaligned after the implantation of manually bent rods are expected to derive the greatest benefit from this ML application. The key uncertainty in this analysis is the limited real-world data of this emerging technology. ML is an iterative process of continuous improvement, identifying correlations within the data collected. As additional surgical data are integrated into predictive models, we anticipate ML technology will enhance decision-making support in surgical strategy and enable better implant precision, resulting in further decreased operating time, reduced mechanical complications, and increased healthcare savings.

Conclusions

ML technology is enabling precision in patient-specific implants, which is expected to drive healthcare cost-savings due to a reduction in instrument failure. Fewer replacement surgeries are an important patient-relevant outcome, especially for adolescents with spinal deformity. This preliminary analysis demonstrates the economic value of ML enabled patient-specific rods to Australian payors, early in its lifecycle.
PP20 Effectiveness And Safety Of Autogenic Training As A Treatment For Medical Conditions
Authors: Alvarez-Perez Yolanda , Rivero-Santanta Amado , Perestelo-Perez Lilisbeth , Duarte-Diaz Andrea , Ramos-García Vanesa , Torres-Castaño Alezandra , Toledo-Chávarri Ana , González-González Nerea , Rodríguez-Rodríguez Leticia , González-Rodríguez Carlos , Serrano-Aguilar Pedro
Published: December 2022

Introduction

Autogenic training consists of reaching a state of deep relaxation through mental representations of physical sensations in different parts of the body. It is a promising technique for improving the psychological well-being of people with chronic diseases, but there are no clinical practice guidelines recommending the use of autogenic training in this population. The aim of this work was to identify, critically evaluate, and synthesize the available evidence on the safety and effectiveness of autogenic training in the prevention and treatment of medical conditions.

Methods

We conducted a systematic search for systematic reviews and randomized controlled trials (RCTs) in MEDLINE, Embase, CINAHL, PsycINFO, and the Cochrane Central Register of Controlled Trials. The selection and assessment of risk of bias of the included studies was carried out independently by two reviewers.

Results

A total of 2,420 references were identified after eliminating duplicates. Of these, 141 were selected for reading the full text, and 13 systematic reviews and 18 RCTs were included. Compared with no intervention or delayed treatment, autogenic training significantly reduced levels of anxiety and depression as well as some physical symptoms (e.g., headaches and atopic dermatitis).

Conclusions

Autogenic training could be useful for improving the psychological well-being and physical symptoms of patients with chronic health conditions and as an additional element in multicomponent intervention programs. However, these conclusions are not definitive due to the low number of studies available for each health condition and their high or unclear risk of bias.
PP26 Cost Utility Of Vaccination Against COVID-19 In Brazil
Authors: Fernandes Ricardo , Santos Marisa , Magliano Carlos Alberto , Thura Bernardo , Macedo Luana , Padila Matheus , França Ana Claudia , Braga Andressa
Published: December 2022

Introduction

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), is a single-strand ribonucleic acid virus that was first identified in January 2020 in patients with viral pneumonia in Wuhan, China. The virus has since spread rapidly around the world, leading the World Health Organization to declare it a pandemic on 11 March 2020. In Brazil there have been 21.8 million cases of SARS-CoV-2 infection and 608,500 deaths. The objective of this study was to evaluate the cost utility of the Oxford, CoronaVac, and Janssen vaccines from the perspective of the Brazilian public health system.

Methods

Three microsimulation models were constructed using individual data. The simulations contained seven transition states related to the natural history of COVID-19. The model with a daily cycle had a time horizon of one year and used data from 289 days of the pandemic. The analysis considered direct medical costs from the Brazilian health system perspective. Outpatient, hospital, and mortality databases were used for the model inputs and patient data were stratified by age. Effective vaccines reduced the likelihood of patients becoming ill. Information on the quality of life of patients receiving treatment in the outpatient or hospital setting and disease sequelae were extracted from the published literature. The main outcome of the analysis was quality-adjusted life-years (QALYs).

Results

The vaccines had incremental cost-utility ratios ranging from USD 4,121 (Oxford) to USD 3,160 per QALY (CoronaVac). The older the population, the lower the incremental cost-utility ratio. Given a willingness-to-pay threshold of BRL 3,129 per QALY, all the vaccines were considered cost effective in the probabilistic sensitivity analysis. The incremental cost-effectiveness ratio stratified by age ranged from USD 6,327 per QALY in patients older than 75 years (Janssen) to USD 20,993 per QALY in patients younger than 59 years (CoronaVac).

Conclusions

The results of this analysis, stratified by patient age, can help in the preparation of a vaccination prioritization plan.
PP35 Defecography (Evacuation Proctography) For The Evaluation Of Pelvic Floor Disorders: A Literature Review
Authors: Akhmedullin Ruslan , Avdeyev Andrey , Benberin Valeriy , Shanazarov Nasrulla , Bariyeva Gulzada , Okesh Makhabbat , Akhmetova Makpal , Aimanova Tansolpan
Published: December 2022

Introduction

Pelvic floor diseases (PFD) often affect the adult population, with approximately 50 percent of women aged 50 years and older suffering from PFD. The condition has complex symptoms that may lead to stress and a negative impact on the quality of life. The USA spends about USD 1 billion annually on inpatient costs as a result of more than 700,000 emergency department visits and 50,000 hospitalizations associated with PFD. Defecography is currently the most commonly used method of diagnostic imaging used to evaluate PFD. This technology is not available in the Republic of Kazakhstan, despite its high diagnostic value.

Methods

In order to assess the clinical effectiveness of defecography, we have conducted a literature search in the MEDLINE database. We selected articles with pairwise comparisons of defecography with other tests: anorectal manometry; balloon expulsion test; electromyography; magnetic resonance imaging (MRI); and, ultrasound.

Results

The findings are primarily based on two meta-analysis (91 studies representing 10,768 cases). The results have been evaluated according to the detection frequency and omission of the following signs: cystocele, middle compartment descent, rectocele, intussusception, rectal prolapse, enterocele, and perineal descent. The literature review did not reveal significant difference in diagnostic value between MR defecography and defecography based on X-ray. However, the imaging endpoints (detection rate of structural and functional abnormalities) for defecography based on X-ray were significantly better than plain radiography.

Conclusions

The defecography is currently considered the gold standard and the most commonly used tool of diagnosis. The implementation does not require an expensive equipment purchase (MR defecography) and is reproducible on conventional X-ray equipment if the necessary inventory is available.
PP40 Health Apps To Manage Depression: Can We Separate The Grain From The Chaff? EvalDepApps Project
Authors: Carrion Carme , Sales-Masnou Ariadna , Eis Sophie , Robles Noemí , Puigdomènech Elisa , Duarte-Díaz Andrea , Vidal-Alaball Josep , Perestelo Lilisbeth , Davins Meritxell , Solà-Morales Oriol
Published: December 2022

Introduction

The use of mobile applications in the treatment of health issues is more frequently becoming common practice. Apps are fast, versatile, and manageable tools that allow the empowerment of patients and professionals, and can reduce the possible stigmatization suffered by some patients, mainly in mental health. There are more than 325,000 health apps on the market, but their impact remains unclear. There are several initiatives to define how health applications should be assessed, however, all of them address only partial aspects of the evaluation. The theoretical frameworks existing to date highlight the need to develop new tools and methodologies to assess mobile applications whose objective is the management of specific pathologies.

Methods

The primary goal of the EvalDepApps project is to develop and pilot an assessment tool for mobile applications whose main objectives are the treatment, monitoring or social support of people suffering from depression. The project is inspired by the results and lessons learnt from a previous project, EVALAPPS, whose central aim was to develop a tool to assess health apps targeted toward the management of overweight and obesity. The first steps of the EvalDepApps project are: (i) to explore and characterize the current landscape of mobile applications available in the market to treat depression through a systematic appraisal, and (ii) to review the existing evidence about the effectiveness and safety of these applications through systematic research of the existing evidence.

Results

Preliminary results show that all the depression management studies were by design based on cognitive-behavioral therapy (CBT) interventions (n=17) and the main management tools included in the services (web or apps) are psychoeducation and coaching (14), together with self-monitoring and feedback messaging (13).

Conclusions

Moreover, although health apps seem to be an interesting strategy to treat depression, there are very few apps available on the markets (30) and the supporting evidence is very limited. This result uncovers a need for further systematic and clinically oriented validation and testing of such apps.
PP43 Impact Of The COVID-19 Pandemic In The Brazilian National Committee for Health Technology Incorporation (Conitec) Recommendation Process
Authors: Cardoso Marilia , Thabane Lehana , Rugolo Juliana , Curado Daniel , Modelli Luis Gustavo , Lima Silvana , Weber Silke
Published: December 2022

Introduction

Health Technology Assessment (HTA) Process assists decision-making in health policies. The COVID-19 pandemic caused a high demand on protocol or guideline updates and incorporation of new drugs or therapies, overwhelming local agencies. A recent study reported that major HTA bodies in England, Scotland, Germany, and Canada reduced their number of drug recommendations in 2020, due to reprioritization of resources and COVID-related challenges. The present study aimed to evaluate the impact of the COVID-19 pandemic at the Brazilian National Committee for Health Technology Incorporation (Conitec) recommendation process.

Methods

This descriptive study evaluated all official recommendation reports available on the Government website in 2020 and 2021, extracting the data of disease category, technology type, the aim of the report, Public Involvement, and final result for the recommendation. The results were presented in tabular and graphical form using the machine learning, through the software R studio and excel.

Results

A total of 168 documents were evaluated, including guidelines and recommendation reports, with no reduction in the number of evaluations considering 2019. In 2020, there was a more significant evaluation of guidelines, and in 2021, a report on the non-incorporation of technologies. There were four specific documents about COVID 19, including vaccines and hospital care guidelines. The most incorporated and non-incorporated technologies were medication, targeting rare and highly prevalent diseases in balance. The Brazilian government was the main proposer. These results are part of the study “A Survey about the core methods of the recommendation reports for Brazilian Ministry of Health carried out by Brazilian Health Technology Assessment Centers”, which will characterize and analyze the core methods of the recommendation reports conducted by the Brazilian HTA Centers.

Conclusions

The pandemic had a low impact on demands in the routine of the Conitec. Establish indicators and technological norms applicable to health services, contribute to the identification of possible new practices, methods or criteria.
PP46 INEAS Guidelines For Pharmacoeconomic Evaluation: Focus On Health-Related Quality of Life Recommendations
Authors: Chemli Jaafar , Harzallah Nabil , Grati Hela , Jebali Marie Christine , Jameleddine Mouna , Hamouda Chokri
Published: December 2022

Introduction

In many low- and middle-income countries scarcity of local data on health outcomes and health-related quality of life (HRQoL) is a hindrance to conducting cost-effectiveness analyses. The Tunisian National Authority for Accreditation and Assessment in Healthcare (INEAS) developed a set of methodological guidelines to support pharmaceutical companies in the submission of health technology assessment (HTA) dossiers. The guidelines include INEAS’ methodological choices for pharmacoeconomic analysis, which take into consideration the specificities and constraints of the Tunisian context. We aimed to present the principal recommendations of the Tunisian guidelines for pharmacoeconomic studies, with a focus on patient-reported outcome and HRQoL measurement.

Methods

The INEAS pharmacoeconomic analysis guidelines were reviewed and the recommendations regarding outcome measurement and HRQoL were retrieved and reported.

Results

To populate the economic model, INEAS recommends using the best available evidence. Health outcomes should be measured in terms of life-years gained and quality-adjusted life-years (QALYs); disability-adjusted life-years can be used but are not the preferred method. To estimate QALYs, INEAS favors the indirect measure of patient preferences with a validated measurement instrument. Alternatively, other measures of utility may be used, including those identified through a systematic review of the scientific literature and the publications of other HTA agencies. Justification and details of the source of the data must be provided. The utility values selected should be recent and representative of the Tunisian population, as far as possible. The guidelines refer to a set of generic preference-based HRQoL instruments, including the EuroQol five-dimensions (EQ5D), the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3), and the Short-Form Six-Dimension (SF-6D), but do not provide any explicit recommendations on their use.

Conclusions

The INEAS pharmacoeconomic analysis guidelines adhere to international best practices but provide more flexibility for overcoming the lack of local data. The INEAS economic guidelines constitutes a further milestone in the process of implementing HTA in Tunisia and in the Middle Eastern and African regions.
PP51 Strengths And Limitations Of Migraine Management Guidelines In The USA and Europe: A Targeted Literature Review
Authors: Perry Richard , Mills Kayla , Ford Janet H. , McCosh Zach
Published: December 2022

Introduction

Migraine, the second leading cause of disability worldwide, remains underdiagnosed and undertreated. Considering the high burden of migraine, we analyzed the strengths and limitations of existing migraine management guidelines.

Methods

A targeted literature review was conducted using MEDLINE on 24 March 2021 to identify current migraine management guidelines (including policies and position statements) published in the English language from France, Germany, Italy, Spain, the United Kingdom, and the USA. This was supplemented by a gray literature search. Disease state or pharmacological management guidelines for adults with migraine comprising any of the following perspectives were included: health economics; payer; health technology assessment; treatment access; and impact of guideline implementation on economic or disease burden. Guidelines were analyzed using the Centers for Disease Control and Prevention (CDC) policy analytical framework, which comprises three domains: problem identification, policy analysis, and strategy or policy development, with ranking criteria for each.

Results

Of 39 selected guidelines, 25 adequately identified problems related to migraine, 35 sufficiently reviewed the literature on migraine treatment, three failed to cite literature, and one lacked sufficient content. Twenty-three guidelines targeted healthcare professionals. Almost all guidelines lacked a stepwise migraine treatment approach; only the American Academy of Family Physicians guideline offered first- and second-line treatment options. Four guidelines mentioned current political forces, and coverage of economic or budgetary impact aspects was limited. Numerous guidelines described the substantial economic burden of migraine and were categorized as ‘high’ for benefits. Public health impact was categorized as ‘high’ for 28 guidelines and budgetary impact was rated as ‘more favorable’ for 27 guidelines. Thirteen guidelines defined a strategy for the intended purpose. Only the United States Department of Health and Human Services pain management guideline met all of the CDC criteria.

Conclusions

Future policies on migraine management may benefit from the inclusion of information on economic data, political feasibility, and public health impact. Furthermore, migraine management guidelines could potentially be improved by considering a comprehensive treatment approach and guideline implementation, as well as addressing knowledge gaps in disease state, public health, and economic aspects.
PP52 Transcranial Magnetic Stimulation For The Treatment Of Cocaine Addiction: A Systematic Review
Authors: Torres-castaño Alezandra , Rivero-Santana Amado , Perestelo-Pérez Lilisbeth , Duarte-Díaz Andrea , Toledo-Chávarri Ana , Ramos-García Vanesa , Álvarez-Pérez Yolanda , Cudeiro-Mazaira Javier , Padrón-González Ivan , Serrano-Pérez Pedro
Published: December 2022

Introduction

Long-term cocaine use is associated with a wide range of cognitive deficits and neuropsychiatric pathologies. Repetitive transcranial magnetic stimulation (rTMS) is an emerging therapeutic strategy that stimulates the prefrontal cortex and may improve cognitive inhibitory control and decision-making. This systematic review aimed to evaluate and synthesize evidence on the safety, effectiveness, and cost effectiveness of rTMS for the treatment of cocaine addiction.

Methods

A systematic review of the literature was carried out. The following electronic databases were searched to identify relevant studies published from inception to October 2020: MEDLINE, Embase, CINAHL, PsycINFO, the Cochrane Central Register of Controlled Trials, and Web of Science. Randomized controlled trials (RCTs), non-randomized controlled trials (nRCTs), case series studies, and full economic evaluations were included.

Results

A total of 12 relevant studies were identified, which included five RCTs, one nRCTs, and six case series studies. None of the studies reported data on cost effectiveness. The results indicated that rTMS reduces cocaine cravings and the number of doses consumed. No serious adverse effects were observed.

Conclusions

The ability to modulate the craving for cocaine in a specific way with non-invasive brain stimulation techniques, such as rTMS, could be a new adjunct to the behavioral treatment of addiction, especially for cocaine use where there is currently no approved pharmacological treatment. Despite the low quality of the included studies, preliminary results indicate that rTMS may reduce cocaine use and cravings. In any case, since this effect is considered moderate, future studies with larger sample sizes and longer follow up are required.
PP76 Database On Evidence-Based Telemedicine In A Hospital Setting
Authors: Svendsen Ida Wagner , Kjølhede Tue , Ølholm Anne Mette , Yderstræde Knud , Kidholm Kristian
Published: December 2022

Introduction

The use of telemedicine services has increased worldwide during recent years because of national strategies for digitalization of health care and the coronavirus disease 2019 (COVID-19) pandemic. However, healthcare professionals often express uncertainty regarding the effectiveness of telemedicine interventions. The TELEMED database (https://telemedicine.cimt.dk/) was introduced by the Centre for Innovative Medical Technology (CIMT) at Odense University Hospital to ensure that hospital managers, healthcare professionals, and other stakeholders have access to scientific studies of telemedicine interventions.

Methods

The database constitutes a structured literature search in PubMed for randomized and non-randomized controlled trials on the use of telemedicine for treating somatic diseases in the hospital setting. The search was conducted by staff members in the health technology assessment unit at CIMT. Identified studies were sorted by first screening titles and abstracts and then by reading full-text versions. The data extracted from the studies included setting, intervention, patient group, type of telemedicine, clinical effect, patient perception, and implementation challenges. The value of each study was also assessed with respect to effectiveness.

Results

A total of 510 articles were selected for data extraction and assessment. The database provides results from 22 different specialties and can be searched using the criteria of medical specialty, country, technology, clinical effect, patient experience, and economic effect. The database serves as an information platform for clinical departments who wish to implement telemedicine services. It has great potential for supporting digital transformation during COVID-19 by providing accessible evidence-based information on patient groups and relevant technologies and their effects. More than 95 percent of the studies in the database that compared telemedicine with a control group showed either statistically significant improvements in clinical outcomes with telemedicine or no statistically significant difference between the two groups.

Conclusions

The TELEMED database provides an easily accessible overview of existing evidence-based telemedicine services. The database is freely available and is expected to be continuously improved and broadened over time.
PP78 Effectiveness And Safety Of The FreeStyle Libre® Glucose Monitoring System For T1DM In Childhood And Adolescence
Authors: González-Pacheco Himar , Ramallo-Fariña Yolanda , Rivero-Santana Amado , Álvarez-Pérez Yolanda , Perestelo-Pérez Lilisbeth , Serrano-Aguilar Pedro , Toledo-Chávarri Ana
Published: December 2022

Introduction

FreeStyle Libre System (FSL) is a minimally invasive technology, which provides frequent information about interstitial glucose levels, which allows adjustment of insulin dose and a reduction in the number of fingersticks. This study aims to evaluate the effectiveness and safety of FSL in childhood and adolescence.

Methods

Prospective case series in 27 Spanish hospitals. Patients aged 4-17 years with type 1 diabetes mellitus (T1DM) were included. Follow-up was done at 3, 6 and 12 months after starting to use the FSL. Outcome measures were HbA1c levels, acute complications of DM (severe hypoglycemia, ketoacidosis), DM knowledge, health-related quality of life, satisfaction and adverse effects. Biochemical glycemic outcomes (e.g., glycemic variability, time in therapeutic range) were available from 3 to 12 months. Mixed regression models with repeated time measurements were implemented.

Results

The mean age of patients was 12.6 years, with 56.4 percent had HbA1c values above 7.5 percent at baseline. This subgroup significantly improved their HbA1c levels at 3, 6 and 12 months (-0.46%, -0.44% and -0.35%, respectively). Patients with controlled HbA1c levels significantly worsened at 12 months (0.29%). There was a significant reduction in severe hypoglycemic episodes, but only in the multiple imputation analysis. In patients controlled at baseline, there were significant reductions between 3 and 12 months in the percentage of time under 55mg/dl (-0.64%), above 250mg/dl (-1.8%) and glycemic variability (-2.6%). In uncontrolled patients, there was a significant reduction in time above 250mg/dl (-5.8%) between 3 and 12 months follow-up. There was no significant improvement in knowledge about disease, although general self-perceived health worsened and general satisfaction improved. Mild adverse events such as skin reactions (14%) and discomfort or pain (11.3%) with no significant reductions in follow-up were recorded.

Conclusions

The use of FSL in childhood and adolescence with T1DM produces a significant reduction in HbA1c levels in patients with uncontrolled HbA1c levels along with a reduction in severe hypoglycemic episodes (in the multiple imputation analysis). FSL-related adverse effects are considered mild.
PP98 Occupational Therapy For Adult Persons With Cognitive Impairments: A Systematic Overview On Clinical Efficacy
Authors: Schnell-Inderst Petra , Conrads-Frank Annette , Stojkov Igor , Krenn Cornelia , Kofler Lisa-Maria , Siebert Uwe
Published: December 2022

Introduction

Damage to the central nervous system (CNS) in adulthood, may lead to cognitive impairments. In Germany, occupational therapy is most often prescribed for neurological diagnoses, including stroke and traumatic brain injury (351 and 343 cases per 100,000, respectively in 2018). For cognitive impairments, the primarily prescribed remedies are sensorimotor-perceptive, motor-functional and neuropsychologically oriented treatment or training of cognitive performance. Here we report the results of a health technology assessment (HTA) report on the clinical efficacy of occupational therapy for patients with cognitive impairments.

Methods

To assess clinical efficacy, a systematic overview was conducted based on published systematic reviews and HTA reports from the last ten years summarizing randomized controlled trials (RCTs) retrieved from four bibliographic databases. The target population included adult patients with cognitive impairments caused by diseases of the CNS, excluding moderate to severe dementia. The intervention studied is occupational therapy compared to no occupational therapy. Outcomes were cognitive abilities, independence, self-determination, health-related quality of life (QoL), and participation in activities of daily living (ADL).

Results

Five systematic reviews comprising 1,316 patients were included. There is evidence for a small statistically significant positive effect on “general cognitive function” (10 RCTs, n=470) and on ADL (4 RCTs, n= 405). A non-quantified positive effect was reported on behavior control (1 RCT, n=96), and conflicting evidence on QoL (2 RCTs, n=214). No effect was found for individual components of cognition (5 RCTs, n=202), self-efficacy (1 RCT, n=98) and social participation (2 RCTs, n=194). The level of the evidence was low for all endpoints due to the high risk of bias and small sample sizes.

Conclusions

Based on this systematic overview, it cannot be demonstrated but also not ruled out that occupational therapy for cognitive impairment is an effective therapy for adults with cognitive impairments. The evidence is very uncertain due to small effects and high risk of bias, low statistical power, and heterogeneity of interventions and study populations.
PP101 Development Process Of The Economic Guidelines In Tunisia
Authors: Jameleddine Mouna , Harzallah Nabil , Chemli Jaafar , Grati Hela , Jebali Marie Christine , Hamouda Chokri
Published: December 2022

Introduction

Health technology assessment (HTA) has become a critical support to health policy decision-making. The HTA evaluation process requires transparency, formalized processes, clear timelines, and standardization according to international best practice. Tunisia is establishing an HTA-based decision-making system through the National Authority for Accreditation and Assessment in Healthcare (INEAS) to ensure impartiality and fairness in decision-making, which is important for an emerging democracy. INEAS opted for a participatory approach in developing the national health economic guidelines to better engage healthcare sector stakeholders in the HTA process. We aimed to present the main phases of the process used to develop the Tunisian health economic guidelines, the methodological choices for pharmacoeconomic evaluations, and the methodological choices for budget impact analyses.

Methods

The different phases of developing the guidelines were listed and reported.

Results

The guidelines were developed under a technical cooperation program of the World Health Organization and involved collaboration between the Institut national d’excellence en santé et en services sociaux (INESSS in Quebec, Canada) and INEAS. The first version of the guidelines was drafted following a review of international HTA guidelines and best practice reference books, taking into account the Tunisian healthcare system context. This first draft was discussed in a workshop with the main health system stakeholders and then peer reviewed by international experts. Based on the feedback from experts, a second version was prepared and published on the INEAS website for public consultation. The Union of Innovative Pharmaceutical Research Companies (SEPHIRE), the National Health Insurance Fund (CNAM), and healthcare professionals provided the majority of feedback. The comments provided by SEPHIRE were discussed during a second workshop. The guidelines were revised and updated based on the comments provided and the final version was published in November 2021.

Conclusions

INEAS adopted a participatory approach for developing its economic guidelines, which enhanced engagement of the major health system stakeholders in the HTA implementation process in Tunisia.
PP103 Early Health Technology Assessment Of Integrated Care To Increase Employment For Persons With Substance Use Disorder
Authors: Støme Linn Nathalie , Rognli Eline Borger , Kværner Kari Jorunn , Wilhelmsen Christian Ringnes , Arnevik Espen Ajo
Published: December 2022

Introduction

The unemployment rates among people being treated for substance use disorder (SUD) are high, with Norwegian estimates ranging from 81 to 89 percent. A promising method for improving vocational outcome is Individual Placement and Support (IPS), where employment support is integrated into the treatment regimen. However, the expense and economic gain are covered by different societal sectors, which may be a disincentive for implementing this method. Thus, the aim of this study was to model the potential socioeconomic value of a new SUD treatment service.

Methods

For the simulation study, we made qualified assumptions about costs and socioeconomic gain based on data from scientific and administrative publications, expert opinion, and a randomized controlled trial of treatments for individuals with SUD that was set in a specialized Norwegian healthcare setting. We made assumptions about the proportion of patients likely to obtain employment after participating in the following three interventions: (i) treatment as usual; (ii) a self-help guide and additional workshop; and (iii) IPS.

Results

Based on early socioeconomic simulation modeling for the three interventions, IPS was found to be cost effective over a period of one to two years.

Conclusions

In this study we used early economic modeling to demonstrate the potential value of IPS for increasing employment rates among patients with SUD. Since it is important to secure evaluative support for an innovation at the earliest possible stage, early economic modeling may assist the innovator in implementing a health service that meets predefined user needs while also reducing associated risks. Although there is much uncertainty in such early stages due to a lack of valid data sources, early economic modeling may provide health authorities with much needed decision support when planning for future health services.