Costs, challenges and opportunities of decentralised chimeric antigen receptor T-cell production: a literature review and clinical experts' interviews.

The objectives were to summarise the evidence and clinical experts' views comparing the use of decentralised produced chimeric antigen receptor (CAR) T-cell therapies versus commercially available products, regarding drug costs, time to finalised product and other reported advantages, disadvantages, challenges and facilitators. A literature review according to the PRISMA guidelines was conducted in Medline, Embase and Trip databases. Publications were included if they reported information on cost estimates, time to finalised products and other outcomes of interest of a decentralised CAR T-cell production strategy.

Patient' and social aspects related to complementary mistletoe therapy in patients with breast cancer: A systematic review commissioned by the German agency for Health Technology Assessment.

Purpose: To mitigate side effects of conventional cancer care and improve quality of life, many patients with breast cancer in German-speaking countries opt for mistletoe therapy in addition to standard treatment. To understand the value for users, we evaluated the domain "Patient and Social aspects" in a health technology assessment on complementary mistletoe therapy in patients with breast cancer.

Methods: A systematic review was conducted according to PRISMA guidelines.

Occupational therapy for persons with cognitive impairments.

Background: Damage to the central nervous system can occur in adulthood, for example, due to stroke, trauma, tumours, or chronic diseases. After damage to the central nervous system, cognitive impairments occur in addition to physical limitations. Occupational therapy is most often prescribed for neurological diagnoses, including stroke and traumatic brain injury.

Evaluation criteria for health apps supporting medication adherence in early-stage technology development - a scoping review.

Introduction: Health apps offer an approach to improve the patients' management of their medication. Although the Digital Healthcare Act (DVG) has created a claim in the statutory health insurance (SHI), the large number of health apps available and their varying quality make it difficult for service providers and especially for medical laypersons to select an adequate high-quality medication app. Manufacturers need guidance for the development of high-quality apps right from the start.

Causal evidence in health decision making: methodological approaches of causal inference and health decision science.

Objectives: Public health decision making is a complex process based on thorough and comprehensive health technology assessments involving the comparison of different strategies, values and tradeoffs under uncertainty. This process must be based on best available evidence and plausible assumptions. Causal inference and health decision science are two methodological approaches providing information to help guide decision making in health care.

Decision-analytic modeling for early health technology assessment of medical devices - a scoping review.

Objective: The goal of this review was to identify decision-analytic modeling studies in early health technology assessments (HTA) of high-risk medical devices, published over the last three years, and to provide a systematic overview of model purposes and characteristics. Additionally, the aim was to describe recent developments in modeling techniques.

Methods: For this scoping review, we performed a systematic literature search in PubMed and Embase including studies published in English or German.

Additional treatment with mistletoe extracts for patients with breast cancer compared to conventional cancer therapy alone - efficacy and safety, costs and cost-effectiveness, patients and social aspects, and ethical assessment.

Background: Chemotherapy is often used in the treatment of breast cancer in women. Side effects such as diarrhea, fatigue, hair loss, fever or disturbances in blood formation impair the women's quality of life. An essential treatment goal of the accompanying mistletoe therapy (MT) used in complementary medicine is to improve the health-related quality of life during cancer therapy.

[Testicular Cancer Screening in Men Aged 16 Years and Older: IQWiG ThemenCheck Health Technology Assessment Report on Medical, Economic, Social, Ethical, Legal and Organisational Aspects].

Background: Testicular cancer occurs mainly in young men between 25 and 45 years and is the most common cancer at this age. Possible testicular cancer early detection measures, clinical palpation and scrotal ultrasound (CUS) or testicular self-examination (TSE) in asymptomatic men aged 16 years and older, could perhaps avoid deaths and aggressive late therapies. Therefore, we investigated whether these measures have an additional benefit compared to the current situation.

A universal outcome measure for headache treatments, care-delivery systems and economic analysis.

Background: The first manuscript in this series delineated a model of structured headache services, potentially cost-effective but requiring formal cost-effectiveness analysis (CEA). We envisaged a need for a new outcome measure for this purpose, applicable to all forms of treatment, care and care-delivery systems as opposed to comparisons of single-modality treatments.

Conception And Delineation: A literature review confirmed the lack of any suitable established measure.

Adult patient access to electronic health records.

Background: To support patient-centred care, healthcare organisations increasingly offer patients access to data stored in the institutional electronic health record (EHR).

Objectives: Primary objective 1. To assess the effects of providing adult patients with access to electronic health records (EHRs) alone or with additional functionalities on a range of patient, patient-provider, and health resource consumption outcomes, including patient knowledge and understanding, patient empowerment, patient adherence, patient satisfaction with care, adverse events, health-related quality of life, health-related outcomes, psychosocial health outcomes, health resource consumption, and patient-provider communication.

Effects of Adult Patient Portals on Patient Empowerment and Health-Related Outcomes: A Systematic Review.

Patient portals are offered by health care organizations to facilitate health information sharing and patient empowerment and support patient-centered care. The aim of this systematic review is to assess the effect of patient portals on patient empowerment and health-related outcomes. After a systematic literature search, ten randomized controlled trials (RCTs) were included in this review.

Recommendations for primary studies evaluating therapeutic medical devices were identified and systematically reported through reviewing existing guidance.

Objectives: The aim of the study was to review existing recommendations on study design, conduct, analysis, and reporting for primary studies of therapeutic medical devices (TMDs) and the closely related field of interventional procedures.

Study Design And Setting: We performed a targeted literature review of publications with recommendations for study design, conduct, analysis, and reporting for primary studies of TMDs and related technologies. We combined an electronic database search with a systematic screening of tables of content of selected journals and scanning the reference lists of relevant articles.

Ten recommendations for assessing the comparative effectiveness of therapeutic medical devices: a targeted review and adaptation.

Objectives: The aim of this study was to review existing guidance on the methods for evaluation of the comparative effectiveness (CE) of therapeutic medical devices (TMDs) and develop recommendations for systematic reviews (SRs) of CE of TMDs as part of health technology assessments.

Study Design And Setting: We performed a targeted literature review of evaluation frameworks and recommendations for evaluation methods for TMDs and related technologies. An electronic database search was combined with systematic screening of tables of content of selected journals and scanning the reference lists of relevant papers.

INTEGRATE-HTA: THE PERSPECTIVE OF EUnetHTA.

The HTA Core Model (HTACM) of EUnetHTA and the INTEGRATE-HTA Model (IHTAM) both provide HTA experts with advanced guidance on how to assess health technologies. In this study, we examine the similarities and differences of the two models, identifying synergies and opportunities for future collaboration. We also consider how such an alignment of the HTACM and IHTAM might be done in practice and present some alternative practical approaches.

A bias-adjusted evidence synthesis of RCT and observational data: the case of total hip replacement.

Evaluation of clinical effectiveness of medical devices differs in some aspects from the evaluation of pharmaceuticals. One of the main challenges identified is lack of robust evidence and a will to make use of experimental and observational studies (OSs) in quantitative evidence synthesis accounting for internal and external biases. Using a case study of total hip replacement to compare the risk of revision of cemented and uncemented implant fixation modalities, we pooled treatment effect estimates from OS and RCTs, and simplified existing methods for bias-adjusted evidence synthesis to enhance practical application.

USING EXPERT OPINION IN HEALTH TECHNOLOGY ASSESSMENT: A GUIDELINE REVIEW.

Objectives: External experts can be consulted at different stages of an HTA. When using vague information sources, it is particularly important to plan, analyze, and report the information processing in a standardized and transparent way. Our objective was to search and analyze recommendations regarding where and how to include expert data in HTA.

Clinical effectiveness of cancer screening biomarker tests offered as self-pay health service: a systematic review.

Background: Biomarker tests are increasingly being offered by laboratories and clinicians as self-pay health services to screen asymptomatic individuals; however, sufficient evidence may not be available to support this practice. We investigated the benefit-harm tradeoffs associated with 11 biomarkers currently offered in Germany as self-pay tests to screen for cancer.

Methods: We systematically searched bibliographic databases for health technology assessments, systematic reviews and randomized-controlled trials (RCTs) through September 2015.

Systematic overview of cost-effectiveness thresholds in ten countries across four continents.

Aim: To provide an overview of thresholds for incremental cost-effectiveness ratios (ICERs) representing willingness-to-pay (WTP) across multiple countries and insights into exemptions pertaining to the ICER (e.g., cancer).

Oncotyrol--Center for Personalized Cancer Medicine: Methods and Applications of Health Technology Assessment and Outcomes Research.

Background: The Oncotyrol - Center for Personalized Cancer Medicine is an international and interdisciplinary alliance combining research and commercial competencies to accelerate the development, evaluation and translation of personalized healthcare strategies in cancer. The philosophy of Oncotyrol is to collaborate with relevant stakeholders and advance knowledge "from bench to bedside to population and back". Oncotyrol is funded through the COMET Excellence Program by the Austrian government via the national Austrian Research Promotion Agency (FFG).

Health technology assessment of medical devices: What is different? An overview of three European projects.

Background: With the growing use and importance of health technology assessment (HTA) in decision making during recent years, health technology assessors, decision makers and stakeholders are confronted with methodological challenges due to specific characteristics of health technologies (e. g., pharmaceuticals, diagnostic tests, screening programs), their developmental environment, and their regulation process.

[HTA goes Europe: European collaboration on joint assessment and methodological issues becomes reality].

Introduction: The standardisation of European HTA and thus the reduction of redundancies require clearly defined processes and methods. The HTA Core Model®, a tool developed by the European Network EUnetHTA, is intended to ensure the transparent production of standardised and high-quality assessments in international collaboration.

Methods: The present paper describes the experience with already published EUnetHTA assessments as well as possibilities for national/local adaptations of these assessments.

Concepts of 'personalization' in personalized medicine: implications for economic evaluation.

Context: This study assesses if, and how, existing methods for economic evaluation are applicable to the evaluation of personalized medicine (PM) and, if not, where extension to methods may be required.

Methods: A structured workshop was held with a predefined group of experts (n = 47), and was run using a modified nominal group technique. Workshop findings were recorded using extensive note taking, and summarized using thematic data analysis.

Appropriate evidence sources for populating decision analytic models within health technology assessment (HTA): a systematic review of HTA manuals and health economic guidelines.

Background: An increasing number of evidence sources are relevant for populating decision analytic models. What is needed is detailed methodological advice on which type of data is to be used for what type of model parameter.

Purpose: We aim to identify standards in health technology assessment manuals and economic (modeling) guidelines on appropriate evidence sources and on the role different types of data play within a model.

Health technology assessment of utilization, practice and ethical issues of self-pay services in the German ambulatory health care setting.

Objectives: The provision of self-pay medical services is common across health care systems, but understudied. According to the German Medical Association, such services should be medically necessary, recommended or at least justifiable, and requested by the patient. We investigated the empirical evidence regarding frequency and practice of self-pay services as well as related ethical, social, and legal issues (ELSI).