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Introduzione: La Sindrome di Ohtahara (SO) è un’encefalopatia epilettica rara resistente ai farmaci, caratterizzata da frequenti spasmi tonici o crisi focali motorie associati allo specifico quadro elettroencefalografico di burst suppression. Esordisce nei primi mesi di vita e rappresenta meno del 4% dei casi di epilessia infantile. La prognosi dipende dall’eziologia e generalmente è sfavorevole con decesso nella maggior parte dei casi durante la prima infanzia. La gestione delle gravi encefalopatie associate a SO è controversa, soprattutto riguardo le strategie per garantire il benessere dei piccoli pazienti e delle loro famiglie, richiedendo una continua modulazione degli interventi medici: dall’intensività degli interventi assistenziali in attesa della diagnosi, alle cure palliative laddove si giunge a una prognosi di inguaribilità, fino alla possibile desistenza da trattamenti intensivi/invasivi quando non più proporzionati al quadro clinico. Obiettivo: Attraverso il caso di M, neonata di 38 settimane, intubata e ventilata meccanicamente sin dalla nascita per assenza di attività respiratoria spontanea, per la quale a circa 4 mesi di vita si è giunti alla diagnosi clinica di SO, si intendono approfondire le questioni etiche connesse: a. alla proporzionalità e appropriatezza etico-clinica dei trattamenti in pazienti per i quali si giunga a una prognosi infausta quoad vitam; b. al processo decisionale da condividere con i genitori, che nel caso specifico non riuscivano ad accettare l’irreversibilità della malattia della figlia, nonostante il supporto psicologico offerto sin dall’inizio. Discussione: In una situazione di patologia probabilmente irreversibile, come nel caso di grave encefalopatia, con disfunzione cortico-sottocorticale e quadro elettro-clinico di SO, associata ad assenza di trigger respiratorio, in cui non emergono elementi in grado di modificare la prognosi quoad vitam, e della cui gravità i genitori possono far fatica ad elaborare la consapevolezza, diventa difficile individuare i limiti dei trattamenti, che potrebbero configurarsi come ostinazione irragionevole e penoso prolungamento del processo del morire. Nel caso di M, durante il suo ricovero nella Terapia Intensiva Neonatale (TIN) della Fondazione Policlinico “A. Gemelli” IRCCS di Roma, i neonatologi hanno costantemente coinvolto i neuropsichiatri infantili per ricercare una causa eziologica e opzioni terapeutiche percorribili, e hanno richiesto il supporto in più fasi delle consulenze di etica clinica per valutare in maniera interdisciplinare la proporzionalità e l’appropriatezza etico-clinica dei trattamenti in atto (in particolare del ventilatore meccanico) e da attuare. Conclusioni: I limiti dei trattamenti e più in generale gli interrogativi legati al fine vita sono questioni etiche sempre più frequenti, anche in TIN, e devono essere costantemente discussi, approfonditi e condivisi all’interno dell’équipe medica e con i genitori, anche quando la comunicazione si presenta difficile. Nel caso di M, solo dopo diverse valutazioni interdisciplinari, si è giunti a una decisione condivisa anche con i genitori di continuare le cure palliative già in essere, di astenersi da interventi intensivi/invasivi in caso di eventi critici, e di favorire il benessere dell’intera famiglia, trasferendo M in un Hospice Pediatrico, dove la morte è avvenuta quando la piccola aveva 11 mesi.

Introduzione: la malattia renale cronica è una causa significativa di decesso. I malati che progrediscono verso la malattia renale allo stadio terminale spesso iniziano la dialisi come trattamento salva-vita. Esistono diverse questioni etiche relative alle decisioni di iniziare/non iniziare o mantenere/non prolungare la dialisi, in particolare per i pazienti con deficit cognitivo e comorbilità, dove la decisione diventa più complessa. Obiettivo: attraverso il caso di un paziente di 56 anni, affetto da cancro laringeo e insufficienza renale cronica end-stage in trattamento sostitutivo emodialitico trisettimanale – oltre che da altre comorbidità – si intendono approfondire gli aspetti etici connessi alla valutazione della proporzionalità e dell’appropriatezza etico-clinica del trattamento dialitico in pazienti che hanno una prognosi infausta “quoad vitam” a breve termine e presentano deficit cognitivo. Discussione: il trattamento dialitico, quale trattamento sostitutivo della funzione renale, sebbene abbia sempre una finalità palliativa e sia tecnicamente praticabile, in determinate circostanze potrebbe configurarsi come ostinazione irragionevole ed essere un penoso prolungamento del processo del morire. Conclusioni: nel valutare l’appropriatezza clinica e la proporzionalità del trattamento dialitico è stata importante una valutazione interdisciplinare e il coinvolgimento dei familiari che ha portato all’elaborazione di un documento condiviso di orientamento etico assistenziale. All’interno di tale documento sono stati individuati gli obiettivi di cura e ciò che rappresentava il miglior bene per il paziente.

Introduzione: La sindrome di Edwards, altrimenti nota come Trisomia 18, è una malattia genetica che può essere caratterizzata da molteplici anomalie congenite multiorgano e spesso è considerata una malattia “incompatibile con la vita”, con un’alta percentuale di gravidanze terminate con aborto (spontaneo o indotto) o il rifiuto alla nascita di possibili trattamenti, anche se alcuni bambini con questa condizione vivono per diversi anni. Obiettivo: Lo scopo di questo lavoro è di discutere l’approccio di etica clinica alla Trisomia 18 attraverso il caso di Angelica – giunta all’attenzione dei curanti nella Fondazione Policlinico Universitario “A. Gemelli” IRCCS in Roma nel 2017 – una bambina affetta da tale patologia che, al momento attuale, ha raggiunto l’età di 4 anni e 10 mesi. Risultati: Dal momento della diagnosi (prenatale) al follow-up attuale è stato messo in atto un approccio eticoclinico, di cui vengono illustrate le valutazioni interdisciplinari che nel tempo sono state effettuate relativamente alla proporzionalità delle possibili opzioni di trattamento, anche di tipo invasivo/intensivo. Conclusioni: La Trisomia 18 non può più essere considerata una malattia “incompatibile con la vita” ed è importante una valutazione interdisciplinare, sia prenatale sia postnatale, che vada a identificare step by step i possibili trattamenti clinicamente ed eticamente appropriati e proporzionati. Tali trattamenti, anche quando invasivi/intensivi, non si configurano necessariamente come over-treatment, ma come la messa in atto di cure palliative finalizzate a migliorare la qualità di vita di questi bambini ed a facilitare la loro gestione domiciliare.

Tra i temi più discussi durante l’emergenza pandemica da Sars-CoV-2 c’è quello che riguarda l’accesso (o l’eventuale sospensione) a trattamenti intensivi (specificatamente i supporti ventilatori), nel caso di forte squilibrio tra necessità cliniche e risorse disponibili. Particolare clamore ha suscitato in Italia la pubblicazione il 6 marzo 2020, dunque in una delle fasi più gravi dell’emergenza, del documento Raccomandazioni di etica clinica per l’ammissione a trattamenti intensivi e per la loro sospensione, in condizioni eccezionali di squilibrio tra necessità e risorse disponibili ad opera della Società Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI), per aver prospettato la possibilità di utilizzare l’età come criterio di accesso ai supporti ventilatori. Obiettivo del presente contributo è discutere l’impostazione teorica di fondo che SIAARTI ha adottato, e il criterio specifico che ha proposto per stabilire la priorità di trattamento dei pazienti intensivi nel contesto dell’emergenza. A ciò farà seguito un breve approfondimento della questione in chiave egualitarista.

Recently new opportunities are emerging for improving the way patients with Haemophilia A are treated. Among these opportunities, efmoroctocog alfa is a first-in-class recombinant factor VIII-Fc fusion protein (rFVIIIFc) produced by recombinant DNA technology with an extended half-life compared with conventional FVIII preparations. The available evidence coming from an Italian HTA report indicates that efmoroctocog alfa provides an effective alternative to conventional FVIII preparations (including standard rFVIIIs) for the management of Haemophilia A. Moreover, by reducing the frequency of injections required, it has the potential to reduce treatment burden, and hence improve adherence to prophylaxis and patient Quality-of-Life.

Objectives To conduct a formative evaluation of applying the VALIDATE approach in practice by (i) assessing how students appreciated the e-learning course, (ii) exploring how, for what purposes and with what outcomes the acquired VALIDATE competences subsequently were used in internships in different institutional contexts, and how this was shaped by these contexts, and (iii) what this shows on real-world use of VALIDATE. Methods Comparative discussion of experiences of applying the VALIDATE approach via a semistructured survey and oral feedback from e-course students; final reports on internships in health technology assessment (HTA) practice, followed by semistructured interviews with interns and supervisors to complement and interpret results. Results All students considered the VALIDATE approach an enlightening and important addition to current HTA knowledge, especially regarding understanding the relation between empirical analysis and normative inquiry, identifying policy relevant questions and using the method of reconstructing interpretive frames for scoping. The latter appeared intellectually challenging and requiring some prior HTA knowledge. The use the VALIDATE approach in practice shows that interns productively redefined the HTA problem, based on appreciation of different stakeholders’ definition of the issue; they experienced constraints from retrieving all relevant perspectives from existing literature as well as from institutional rules and routines. Conclusions Some challenges in applying the VALIDATE approach deserve attention for its future use: currently used research approaches often assume a problem as “given”; and the data needed on different perspectives is often not reported in scientific literature. Finally, data gathering on and evaluation of value dimensions was experienced as challenging.

Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (O’Rourke et al. [2020, International Journal of Technology Assessment in Health Care 36, 187–90]). HTA is, then, where facts and values meet. But how, where, and when do facts and values meet in HTA? Currently, HTA is usually portrayed as a sequential process, starting with empirical analysis (assessment), followed by a deliberation on the implications of the findings for a judgment of a health technology’s value (appraisal). In this paper, we will argue that in HTA, empirical analysis and normative inquiry are much more closely entwined. In fact, as we hope to show, normative commitments act as an indispensable guide for the collection and interpretation of empirical evidence. Drawing on policy sciences, we will suggest a concrete methodology that can help HTA practitioners to integrate empirical analysis and normative inquiry in a transparent way. The proposed methodology can be conceived as a concrete means for conducting a scoping exercise in HTA. Moreover, it offers a distinct way of giving stakeholders a structural and constructive role in HTA. This paper outlines the approach developed by the values in doing assessments of health technologies project, a project funded by the Erasmus+ program (contract number 2018-1-NL01-KA203-038960), which is the European Union’s program to support education, training, youth, and sport in Europe. The project has resulted in an E-learning course, an accompanying handbook, and a consensus statement, all freely available from the project’s website www.validatehta.eu.

L’articolo espone l’esperienza del Servizio di Consulenza di Etica Clinica (Servizio CEC) dell’Istituto di Bioetica e Medical Humanities dell’Università Cattolica del Sacro Cuore per la Fondazione Policlinico Universitario “Agostino Gemelli” IRCCS (FPG) di Roma, dal 1992 ad oggi. Dopo una introduzione generale sul significato e gli scopi della consulenza di etica clinica, l’articolo prende in esame la casistica del Servizio. A tal fine è stata realizzata un’indagine retrospettiva di tutte le consulenze di etica clinica (CEC) richieste ed eseguite dal Servizio CEC dalla sua istituzione ad agosto 2019. È stato analizzato l’andamento del Servizio e confrontato il numero di CEC eseguite nei primi 20 anni, quando il Servizio utilizzava una modalità prevalentemente cartacea, con il numero di CEC eseguite da quando il Servizio è stato inserito sul Sistema Informativo interno del Policlinico il 1 gennaio 2016 dove le CEC sono tracciate elettronicamente. In particolare, sono stati individuati e fatti oggetto di discussione critica i dati relativi a: numero delle richieste di CEC, numero delle CEC elaborate, aree cliniche che hanno richiesto le CEC, forme assunte dalla consulenza (consulenza classica o documento condiviso di orientamento etico-assistenziale), quesiti etici – e non solo etici – maggiormente emersi.

Una ripresa secondo una dimensione pubblica del dibattito sulla giustizia distributiva in Sanità si è verificata in tempi recenti con l’introduzione dei nuovi farmaci antivirali ad azione diretta per il trattamento dei pazienti affetti da epatite C, estremamente efficaci nel curare la patologia ma dai costi esorbitanti. Obiettivo del presente contributo è di fornire un breve approfondimento sul tema dei c.d. “farmaci insostenibili”, esaminato sotto un particolare modello di giustizia distributiva, ossia l’egualitarismo, e secondo la prospettiva intergenerazionale. La conclusione è che ad oggi i sistemi sanitari stanno affrontando il problema della sostenibilità attraverso l’ottimizzazione della spesa farmaceutica, ma non sembrano ancora ben equipaggiati per affrontare l’eventualità di una divaricazione inaggirabile tra domanda e offerta di questa tipologia di farmaci. Quest’ultima va affrontata in riferimento all’idea di giustizia distributiva che ha una società, e più specificatamente, alla quantità di risorse che una società è disposta a pagare per la cura di un suo membro. Da ultimo, in termini di giustizia distributiva, l’idea – spesso supportata dalle analisi di farmacoeconomia – che sia giustificabile spendere una cifra molto elevata oggi per ricavare risparmi nel lungo periodo non è di per sé coerente con le principali teorie della giustizia, e necessita di argomenti a sostegno estrinseci ai loro presupposti teorici.

Prioritization of COVID-19 vaccines is one of the most relevant topics in the current pandemic emergency. Prioritization decisions are political decisions that are value-laden, and as such of ethical nature. Despite the clear political and ethical nature of this topic, prioritization decisions are often interpreted and presented as scientific decisions. The aim of this article is twofold. First, we aim to show critical points that characterize certain pandemic vaccination plans from the ethical viewpoint using four dimensions (problem definitions, incorporation of different perspectives, context, and specification). The four dimensions were drawn from findings of the European project “VALIDATE” (VALues In Doing Assessments of healthcare TEchnologies”, https://validatehta.eu). Second, we aim to reframe the issue about prioritization itself in the light of the four dimensions mentioned. Our conclusion is that policy-problem definitions, incorporation of different perspectives, contextual considerations and specification of moral principles seem to be common critical points of some vaccination plan documents. The European project “VALIDATE” seems to be able to provide a useful and profitable approach to address many of these critical points.

A critical transformation of the current era seems to be medicine’s conquest of old age, beginning with its acquired ability to prolong human life. Providing increasingly effective health care for the elderly has become the most extensive of medicine’s frontiers. This is also an ideal of a moral nature: it is a discrimination unworthy of medicine the idea that the age of the patient can be a variable to be taken into account, if there are the technical means to be able to bring him the benefits (the standards of treatment should not take into account the age). However, not everyone considers this orientation justified.

Una delle questioni più spinose che accompagna il dibattito sulla campagna vaccinale anti-SARS-CoV-2/COVID- 19 è quella che riguarda l’accesso ai vaccini, ossia l’ordine di priorità da seguire, soprattutto nella fase iniziale di somministrazione, caratterizzata da un forte squilibrio tra domanda e offerta. In Italia, l’accesso è regolato dal Piano strategico dell’Italia per la vaccinazione anti-SARS-CoV-2/COVID-19 del dicembre 2020, a cui ha fatto seguito un documento di aggiornamento del febbraio 2021. L’obiettivo del presente contributo è di analizzare sotto un profilo etico i due documenti, approfondendo in particolare il tema delle giustificazioni che sono alla base delle scelte prese e del loro inquadramento rispetto alla prospettiva egualitarista del Servizio Sanitario Nazionale (SSN) italiano.

ObjectivesThere is no consensus on who might be qualified to conduct ethical analysis in the field of health technology assessment (HTA). Is there a specific expertise or skill set for doing this work? The aim of this article is to (i) clarify the concept of ethics expertise and, based on this, (ii) describe and specify the characteristics of ethics expertise in HTA.MethodsBased on the current literature and experiences in conducting ethical analysis in HTA, a group of members of the Health Technology Assessment International (HTAi) Interest Group on Ethical Issues in HTA critically analyzed the collected information during two face-to-face workshops. On the basis of the analysis, working definitions of “ethics expertise” and “core competencies” of ethics experts in HTA were developed. This paper reports the output of the workshop and subsequent revisions and discussions online among the authors.ResultsExpertise in a domain consists of both explicit and tacit knowledge and is acquired by formal training and social learning. There is a ubiquitous ethical expertise shared by most people in society; nevertheless, some people acquire specialist ethical expertise. To become an ethics expert in the field of HTA, one needs to acquire general knowledge about ethical issues as well as specific knowledge of the ethical domain in HTA. The core competencies of ethics experts in HTA consist of three fundamental elements: knowledge, skills, and attitudes.ConclusionsThe competencies described here can be used by HTA agencies and others involved in HTA to call attention to and strengthen ethical analysis in HTA.

Objective:To investigate, through a questionnaire, older adults’ demographic and socio-economic characteristics, knowledge, attitudes and practices in terms of food safety and healthy diet; and to develop dietary and hygiene indices able to represent participants’ nutritional and food safety behaviour, exploring their association with demographic and socio-economic factors.Design:One-year cross-sectional study.Setting:Gemelli Teaching Hospital (Rome, Italy).Participants:People aged ≥65 years, Italian speaking, accessing the Centre of Ageing Medicine.Results:Mean age of the sample was 74 (sd 7·7) years. Subjective perception of a safe diet was high: 64·2 % of respondents believed they have a balanced diet. Interviewees got informed about proper nutrition mainly from television, magazines, newspapers, Internet (29·9 %) and from health professionals (34·8 %) such as dietitians, whereas 15·4 % from general practitioners. Regarding food safety, 33·8 % of participants reported to consume expired food, even more than once per month; between 80 and 90 % of participants reported to follow food safety practices during preparation and cooking, even though 49·3 % defrosted food at room temperature. Calculated dietary and hygiene indices showed that the elderly participants were far from having optimal nutritional and food safety behaviours.Conclusions:These results suggest it is necessary to increase the awareness of older adults in the matter of healthy diet and food safety. Specific and targeted educational interventions for the elderly and their caregivers could improve the adoption of recommended food safety practices and safe nutritional behaviours among older adults.

"This work is aimed at critically illustring the eight-year experience of the Master in “Clinical Bioethics Consultation” (2013-2020). This advanced second-level Master was promoted in 2013 by the Catholic University of the Sacred Heart of Rome, and co-worked by other Italian clinical as well as academic institutions (University Campus Bio-medico of Rome, Insubria University of Varese, “Federico II” University of Naples, Lanza Foundation of Padua, Local Health and Social Care Unit n. 7 (ULSS) of Veneto Region, Treviso; Ospedale San Giovanni Calibita Fatebenefratelli – Isola Tiberina, Rome, and Italian Group for clinical ethics consultation (GIBCE)). To this aim, it first will discuss two points: on the one hand, an epistemological one, i.e. the justification of the activity of ethics consultant in clinical settings supported by the authors; on the other hand, a pedagogical one, i.e. the identification of the learning needs clinical bioethics gives birth to. The second part of the work will focus on the experience of the Master, explaining its basic features (objectives, methods, contents, evaluation tools, etc), offering a critical review, and identifying the challenges this initiative has to face in the next future. "

"Introduction. The recent introduction of extremely effective drugs in treating diseases, but associated with exorbitant costs raised several issues in terms of distributive justice. However, in this debate justice is widely thought in intragenerational terms. The work will explore the concept of intergenerational health care justice, in particular the argument, often used to justify the introduction of this type of drugs, according to which the vast amount of money spent now will allow to have savings in the long run. The recent introduction of some drugs that are extremely effective in treating diseases but associated with exorbitant costs, raised several issues in terms of distributive justice. However, in this debate justice is widely thought in intragenerational terms. Methods: A review of key documents on intergenerational justice was conducted, followed by a nonsystematic review of peer-reviewed and gray literature. The existing material was analyzed and a draft manuscript was prepared and discussed. Some experts carried out the revision of the manuscript until consensus was reached. Results: The concept of intergenerational health care justice has never been well explored. From an intergenerational point of view, the argument – which is often supported by pharmaco-economic evaluations – according to which the vast amount of money spent now for this type of drugs will allow to have savings in the long run is not in itself coherent with the main theories of justice. Conclusions: Considerations that are extrinsic to the assumptions of the main theories of justice are needed in order to justify the argument above. "

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El artículo presenta un caso clínico, dirigido en el año 2011 por el equipo de servicio de consulta ética clínica del Instituto de Bioética y Humanidades Médicas de la Facultad “Agostino Gemelli” de Medicina de la Universidad Católica del Sacro Cuore en Roma (Italia). El caso clínico se refiere a los dilemas éticos sobre las perspectivas del paciente para recibir un trasplante hepático ortotópico porque no era residente del país y carecía de un cuidador para asistirlo durante el periodo de seguimiento, así como de un lugar para quedarse después de la cirugía.

Contains fulltext : 168280.pdf (Publisher’s version ) (Open Access) Ethics has been identified as a key element in Health Technology Assessment (HTA) since its conception. However, ethical issues are still not frequently addressed explicitly in HTA. Several valuable reasons have been identified. The basis of the article is the claim that ethics is often not part of HTA for "epistemological reasons". Hence, the main aim of the contribution is to explore in more details and emphasize them by using the fact/value dichotomy. Our conclusion is that current HTA configuration is predominantly based on the comparison among objective and empirically testable "facts", whilst ethics is not empirically testable. In this sense, there is a sort of "epistemological gap", which can explain why it is so difficult to integrate ethics in HTA. We suggest that the epistemological differences among the various domains of HTA are addressed more explicitly.

Despite improvements in blood donor selection and screening procedures, transfusion recipients can still develop complications related to infections by known and emerging pathogens. Pathogen reduction technologies (PRT) have been developed to reduce such risks. The present study, developed whithin a wider health technology assessment (HTA) process, was undertaken to estimate the costs of the continuing increase in the use of platelet PRT in Italy.A multidisciplinary team was established to perform the HTA and conduct a budget impact analysis. Quantitative data on platelet use were derived from the 2015 national blood transfusion report and from the Italian Platelets Transfusion Assessment Study (IPTAS). The current national fee of 60 Euro per platelet PRT procedure was used to quantify the costs to the Italian National Health Service (INHS). The analysis adopts a 3-year time-frame. In order to identify the impact on budget we compared a scenario representing an increased use of PRT platelets over time with a control scenario in which standard platelets are used.Progressive implementation of PRT for 20%, 40% and 66% of annual adult platelet doses could generate an increase in annual costs for the INHS amounting to approximately 7, 14 and 23 million Euros, respectively. Use of kits and devices suitable for the treatment of multiple adult platelet doses in one PRT procedure could lower costs.In order to fully evaluate the societal perspective of implementing platelet PRT, the increase in costs must be balanced against the expected benefits (prevention of transfusion-transmissible infections, white cell inactivation, extension of platelet storage, discontinuation of pathogen detection testing). Further studies based on actual numbers of platelet transfusion complications and their societal cost at a local level are needed to see the full cost to benefit ratio of platelet PRT implementation in Italy, and to promote equal treatment for all citizens.

Contains fulltext : 193415.pdf (Publisher’s version ) (Closed access) OBJECTIVE: To compare and contrast different methods of qualitative evidence synthesis (QES) against criteria identified from the literature and to map their attributes to inform selection of the most appropriate QES method to answer research questions addressed by qualitative research. STUDY DESIGN AND SETTING: Electronic databases, citation searching, and a study register were used to identify studies reporting QES methods. Attributes compiled from 26 methodological papers (2001-2014) were used as a framework for data extraction. Data were extracted into summary tables by one reviewer and then considered within the author team. RESULTS: We identified seven considerations determining choice of methods from the methodological literature, encapsulated within the mnemonic Review question-Epistemology-Time/Timescale-Resources-Expertise-Audience and purpose-Type of data. We mapped 15 different published QES methods against these seven criteria. The final framework focuses on stand-alone QES methods but may also hold potential when integrating quantitative and qualitative data. CONCLUSION: These findings offer a contemporary perspective as a conceptual basis for future empirical investigation of the advantages and disadvantages of different methods of QES. It is hoped that this will inform appropriate selection of QES approaches.

This chapter aims to analyze the impact of the rise of Big Data on ethical issues appertaining to the beginning of life issues. This was carried out in the light of available scientific literature. We have structured the chapter in three main parts: the first part is a general overview on Big Data as a whole, as it exceeds Biomedicine field; the second part reviews of main questions and applications of Big Data in health care; and the third part analyzes its potential usage and bioethical issues generated by it when detailing beginning of life issues. We have critically reviewed the main issues, including the ethical, legal, and social implications pertaining to this topic and found that, even if the Big Data era is in its infancy in this field, both from theoretical and operational points of view, it has a major development potential, and stakeholders should take it into account and use it at its full potential.

Objectives: The aim of this study was to identify and discuss appropriate approaches to integrate ethical inquiry in health technology assessment (HTA).Methods: The key question is how ethics can be integrated in HTA. This is addressed in two steps: by investigating what it means to integrate ethics in HTA, and by assessing how suitable the various methods in ethics are to be integrated in HTA according to these meanings of integration.Results: In the first step, we found that integrating ethics can mean that ethics is (a) subsumed under or (b) combined with other parts of the HTA process; that it can be (c) coordinated with other parts; or that (d) ethics actively interacts and changes other parts of the HTA process. For the second step, we found that the various methods in ethics have different merits with respect to the four conceptions of integration in HTA.Conclusions: Traditional approaches in moral philosophy tend to be most suited to be subsumed or combined, while processual approaches being close to the HTA or implementation process appear to be most suited to coordinated and interactive types of integration. The article provides a guide for choosing the ethics approach that appears most appropriate for the goals and process of a particular HTA.

Objectives: The INTEGRATE-HTA project provided methodology to evaluate complex technologies. This study provides guidance on how to retrieve and critically appraise available evidence on moderators and predictors of treatment effects and on patient preferences for treatment outcomes as a source of complexity.Methods: Search filters for PubMed were developed by hand-searching a large volume of articles reporting on relevant aspects. Search terms were retrieved from selected papers and algorithmically combined to find the optimal combination of search terms. For the development of the appraisal checklists literature was searched in PubMed and Google Scholar together with citation chasing. For the CHecklist for the Appraisal of Moderators and Predictors (CHAMP) a Delphi procedure was used to value a set of eligible appraisal criteria retrieved from the literature.Results: Search filters were developed optimized for different accuracy measures. The final version of CHAMP consists of a seventeen questions covering the design, analysis, results and transferability of results of moderator and predictor analysis. The final checklist for appraisal of literature on patient preferences for treatment outcomes consist of six questions meant to help the user to identify relevant quality issues together with a guidance toward existing tools concerning the appraisal of specific preference elicitation methods.Conclusions: Incorporating knowledge on subgroups for whom a specific treatment will produce more benefit holds the promise of better targeting and, ultimately, enhancing overall effectiveness and efficiency of healthcare technology. Finally, incorporating information on preferences for treatment outcomes will foster health technology assessment that addresses outcomes that are important to patients.

Objectives: The aim of this study was to analyze and describe process and outcomes of two pilot assessments based on the HTA Core Model, discuss the applicability of the model, and explore areas of development.Methods: Data were gathered from HTA Core Model and pilot Core HTA documents, their validation feedback, questionnaires to investigators, meeting minutes, emails, and discussions in the coordinating team meetings in the Finnish Office for Health Technology Assessment (FINOHTA).Results: The elementary structure of the HTA Core Model proved useful in preparing HTAs. Clear scoping and good coordination in timing and distribution of work would probably help improve applicability and avoid duplication of work.Conclusions: The HTA Core Model can be developed into a platform that enables and encourages true HTA collaboration in terms of distribution of work and maximum utilization of a common pool of structured HTA information for national HTA reports.

Background:Although value issues are increasingly addressed in health technology assessment (HTA) reports, HTA is still seen as a scientific endeavor and sometimes contrasted with value judgments, which are considered arbitrary and unscientific. This article aims at illustrating how numerous value judgments are at play in the HTA process, and why it is important to acknowledge and address value judgments.Methods:A panel of experts involved in HTA, including ethicists, scrutinized the HTA process with regard to implicit value judgments. It was analyzed whether these value judgments undermine the accountability of HTA results. The final results were obtained after several rounds of deliberation.Results:Value judgments are identified before the assessment when identifying and selecting health technologies to assess, and as part of assessment. They are at play in the processes of deciding on how to select, frame, present, summarize or synthesize information in systematic reviews. Also, in economic analysis, value judgments are ubiquitous. Addressing the ethical, legal, and social issues of a given health technology involves moral, legal, and social value judgments by definition. So do the appraisal and the decision-making process.Conclusions:HTA by and large is a process of value judgments. However, the preponderance of value judgments does not render HTA biased or flawed. On the contrary they are basic elements of the HTA process. Acknowledging and explicitly addressing value judgments may improve the accountability of HTA.

Objective The study proposes a possible roadmap for the ethical assessment of sham surgery clinical trials (CTs), focusing on methodological aspects, as a result of the lack of this type of practical tool in the literature/practice. Background Surgical procedures are frequently conducted without closely controlled studies. For this reason, these procedures are less rigorous than those for drug/device clinical trials. The aim of a sham (placebo) surgery CT is to carry out a surgical CT with a legitimate control group. The use of sham surgery is controversial from an ethical point of view. Methods This evaluation system is set up according to ICH/GCP, World Medical Association Declaration of Helsinki, CONSORT 2010 standards. The proposed roadmap is based on the following 4 steps/levels: safety/clinical indications; adequacy of trial methodology/design adopted for a sham surgery CT; specific informed consent, and economic issues. Results A flowchart is proposed which can be used at two levels: as a basic guideline for the design of a surgical protocol representing a benchmark level of care; and a multiaxial assessment considering the first two sources of morality of human acts according to Aristotelian ethics: the object of the act (step 1) and some of its circumstances (steps 2-4). Conclusions The use of a placebo and of double-blind control groups in surgery CTs would improves the quality of results, providing that an accurate ethical assessment procedure is in place, firstly to ensure patient safety and secondly to prevent abuses/procedural biases. Future testing of the proposed flowchart is outlined.

Background: Stakeholders are people with an interest in a topic. Internationally, stakeholder involvement in palliative care research and health technology assessment requires development. Stakeholder involvement adds value throughout research (from prioritising topics to disseminating findings). Philosophies and understandings about the best ways to involve stakeholders in research differ internationally. Stakeholder involvement took place in seven countries (England, Germany, Italy, Lithuania, the Netherlands, Norway and Poland). Findings informed a project that developed concepts and methods for health technology assessment and applied these to evaluate models of palliative care service delivery. Aims: To report on stakeholder involvement in the INTEGRATE-HTA project and how issues identified informed project development. Design: Using stakeholder consultation or a qualitative research design, as appropriate locally, stakeholders in seven countries acted as ‘advisors’ to aid researchers’ decision making. Thematic analysis was used to identify key issues across countries. Setting/participants: A total of 132 stakeholders (82 professionals and 50 ‘lay’ people) aged ⩾18 participated in individual face-to-face or telephone interviews, consultation meetings or focus groups. Results: Different stakeholder involvement methods were used successfully to identify key issues in palliative care. A total of 23 issues common to three or more countries informed decisions about the intervention and comparator of interest, sub questions and specific assessments within the health technology assessment. Conclusion: Stakeholders, including patients and families undergoing palliative care, can inform project decision making using various involvement methods according to the local context. Researchers should consider local understandings about stakeholder involvement as views of appropriate and feasible methods vary. Methods for stakeholder involvement, especially consultation, need further development.

Objectives: Internationally, funders require stakeholder involvement throughout health technology assessment (HTA). We report successes, challenges, and lessons learned from extensive stakeholder involvement throughout a palliative care case study that demonstrates new concepts and methods for HTA.Methods: A 5-step “INTEGRATE-HTA Model” developed within the INTEGRATE-HTA project guided the case study. Using convenience or purposive sampling or directly / indirectly identifying and approaching individuals / groups, stakeholders participated in qualitative research or consultation meetings. During scoping, 132 stakeholders, aged ≥ 18 years in seven countries (England, Italy, Germany, The Netherlands, Norway, Lithuania, and Poland), highlighted key issues in palliative care that assisted identification of the intervention and comparator. Subsequently stakeholders in four countries participated in face–face, telephone and / or video Skype meetings to inform evidence collection and / or review assessment results. An applicability assessment to identify contextual and implementation barriers and enablers for the case study findings involved twelve professionals in the three countries. Finally, thirteen stakeholders participated in a mock decision-making meeting in England.Results: Views about the best methods of stakeholder involvement vary internationally. Stakeholders make valuable contributions in all stages of HTA; assisting decision making about interventions, comparators, research questions; providing evidence and insights into findings, gap analyses and applicability assessments. Key challenges exist regarding inclusivity, time, and resource use.Conclusion: Stakeholder involvement is feasible and worthwhile throughout HTA, sometimes providing unique insights. Various methods can be used to include stakeholders, although challenges exist. Recognition of stakeholder expertise and further guidance about stakeholder consultation methods is needed.