European collaboration on health technology assessment: looking backward and forward.

The establishment of health technology assessment (HTA) has been an important topic in Europe for many years. There have been a series of activities starting with first projects in 1994 leading to joint actions from the European Network of HTA (EUnetHTA) ending in 2021. This long interval of engagement with HTA structures, methodology, and processes by all member states led to a reliable basis for European collaboration in HTA. This article shows milestones and developments from EUR-ASSESS in 1994 through the progress of EUnetHTA and the accompanying EU-HTA-Network up to the recent elaboration of the EU-HTA-Regulation. With the EU-HTA-Regulation HTA collaboration is taken out of the trial phase of more than 15 years. Through the previous EU HTA collaboration, the appreciation and understanding of the differences and complexities behind the HTA processes in the EU healthcare systems have improved. It is now necessary to make the final steps toward a sustainable European Network for HTA.

Building a model of health technology assessment cooperation: lessons learned from EUnetHTA joint action 3.

OBJECTIVE: The European Network for Health Technology Assessment (EUnetHTA) was established in 2006. During its final project phase (joint action 3 [JA3]), it undertook an activity to define the scientific and technical principles of a model of health technology assessment (HTA) cooperation in Europe. This policy article presents the key learnings from JA3 partners about developing a model of HTA cooperation. METHODS: There were two phases to the activity: (i) A descriptive phase to describe the elements of HTA cooperation that were already in place in EUnetHTA JA3 and to identify which elements could be improved or were missing. (ii) An analytic phase synthesizing the data collected to identify learnings from the JA3 and to define the scientific and technical principles for a future model of HTA cooperation. RESULTS: Learnings for developing HTA cooperation were identified in regard to the framework used to support the cooperation, the HTA activities undertaken, the involvement of internal and external actors, managing decision making and the required human resources and support services needed to undertake HTA activities and to coordinate collaboration. CONCLUSIONS: These learnings coming from the experiences of the EUnetHTA JA3 are useful to inform discussions on a European Union regulation for HTA cooperation as well as subsequent work to set up the structures that will be defined in the regulation. The findings also have broader applicability and are relevant to individuals, groups, and organizations setting up HTA programs or establishing their own international collaborations.

The fourth edition of the European Network for Health Technology Assessment Forum: highlights and outcomes.

The European Network for Health Technology Assessment (EUnetHTA) organizes an annual Forum with stakeholders to receive feedback on its activities, processes, and outputs produced. The fourth edition of the EUnetHTA Forum brought together representatives of HTA bodies, patient organizations, healthcare professionals (HCPs), academia, payers, regulators, and industry. The aim of this paper is to provide an overview of the highlights presented at the 2019 EUnetHTA Forum, reporting the main items and themes discussed in the plenary panel and breakout sessions. The leading topic was the concept of unmet medical need seen from different stakeholders' perspectives. Breakout sessions covered the joint production of assessment reports and engagement with payers, patients, and HCPs. Synergies, pragmatism, and inclusiveness across Member States and stakeholders were emphasized as leading factors to put in place a collaboration that serves the interest of patients and public health in a truly European spirit.

EVIDENCE REQUIREMENTS FOR REIMBURSEMENT OF PHARMACEUTICALS ACROSS EUROPE.

OBJECTIVES: The objective of this study was to compare evidence requirements for health technology assessment of pharmaceuticals by national agencies across Europe responsible for reimbursement decisions focusing specifically on relative effectiveness assessment. METHODS: Evidence requirements from thirty-three European countries were requested and twenty-nine national agencies provided documents to review. Data were extracted from national documents (manufacturer's submission templates and associated guidance) into a purpose-made framework with categories covering information about the health condition, the technology, clinical effectiveness and safety. RESULTS: The level of detail in the required evidence varies considerably across countries. Some countries include specific questions while others request information under general headings. Some countries include all information in a single document, which may or may not include guidance on how to complete the template. Others have specific guidance documents or methods and process manuals that help with the completion of the submission templates. Despite differences in quantity and detail, the content of the evidence requirements is broadly similar. All countries ask for information on the health technology, target disease, and clinical effectiveness and safety. However, one country only requests clinical effectiveness information as part of cost-effectiveness analyses. We found twenty-six evidence requirements for which generic answers may apply across borders and nineteen in which countries requested nationally specific information. CONCLUSIONS: This work suggests that it would be possible to put together a minimum set of evidence requirements for HTA to support reimbursement decisions across Europe which could facilitate collaboration between jurisdictions.

Systematic reviews and their application to research in speech and language therapy: a response to T. R. Pring's 'Ask a silly question: two decades of troublesome trials' (2004).

BACKGROUND: The advent of evidence-based healthcare has seen a rise in the use of systematic reviews to bring together the findings from research studies. The use of systematic reviews in speech and language therapy (SLT) was criticized in this journal in 2004 by T. R. Pring. It was claimed that their findings are misleading due to the potential inclusion of biased data, and uninformative due to a lack of detail in the reporting of interventions. It is argued that outcome research should be carried out in a series of phases in which small-scale research precedes large-scale research. This, it is argued, is most likely to demonstrate statistically significant effects and also help to ensure that therapies become sufficiently defined so that clinicians can apply them in practice. AIMS: This paper argues that the above criticism of systematic reviews is based on a narrow conception of their capabilities: on the popular misapprehension that all systematic reviews answer effectiveness questions using only experimental studies and contain meta-analyses. Different methods for systematic reviews are described and their application within clinical outcome research is discussed with reference to a phased structure for empirical enquiry. MAIN CONTRIBUTION: Systematic reviews seek to identify and synthesize information within a given topic area. They are used to answer a wide range of research questions and the studies they include are not limited exclusively to experimental designs. Methods of synthesis can include both statistical approaches, such as meta-analysis, and 'qualitative' approaches, such as meta-ethnography and thematic analysis. Knowledge of the current state of research is essential for a sequentially phased approach within outcome research to operate. Since systematic reviews are summaries of research activity, they can provide this knowledge and should therefore be considered a valuable tool within outcome research. CONCLUSIONS: A systematic review using 'qualitative' and/or statistical methods for combining studies can be carried out within or across any of the phases within outcome research. Far from being uninformative, this can help bring together what is, and what is not, known and indicate the kinds of therapies that may be beneficial in the clinical setting and therapies which would benefit from further research and development.

The efficacy of treatment for children with developmental speech and language delay/disorder: a meta-analysis.

A meta-analysis was carried out of interventions for children with primary developmental speech and language delays/disorders. The data were categorized depending on the control group used in the study (no treatment, general stimulation, or routine speech and language therapy) and were considered in terms of the effects of intervention on expressive and receptive phonology, syntax, and vocabulary. The outcomes used in the analysis were dependent on the aims of the study; only the primary effects of intervention are considered in this review. These were investigated at the level of the target of therapy, measures of overall linguistic development, and broader measures of linguistic functioning taken from parent report or language samples. Thirty-six articles reporting 33 different trials were found. Of these articles, 25 provided sufficient information for use in the meta-analyses; however, only 13 of these, spanning 25 years, were considered to be sufficiently similar to be combined. The results indicated that speech and language therapy might be effective for children with phonological or expressive vocabulary difficulties. There was mixed evidence concerning the effectiveness of intervention for children with expressive syntax difficulties and little evidence available considering the effectiveness of intervention for children with receptive language difficulties. No significant differences were found between interventions administered by trained parents and those administered by clinicians. The review identified longer duration (>8 weeks) of therapy as being a potential factor in good clinical outcomes. A number of gaps in the evidence base are identified.

Speech and Language Therapy: Its Potential Role in CAMHS.

This review examines the implications of a recent systematic review of speech and language therapy interventions for child mental health services. The premise is that communication skills and mental health are closely related and that intervention in the one field may have an impact on skills and achievement in the other. The paper begins by discussing what we know about the relationship between speech/language and behavioural difficulties; it then reports results from the review, before examining the implications for practice and policy.