TEMPEST: An integrative model for health technology assessment

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<ul><li><p>w.e</p><p>Available online at www.sciencedirect.com</p><p>o</p><p>Po</p><p>Abstract</p><p>proaches to fund state-run healthcare systems by introducing</p><p>communications technology (ICT) is increasing and is</p><p>greater control over their healthcare choices, moving from</p><p>National Programme for Information Technology (NPfIT) in</p><p>Health Policy and Technology (2012) 1, 35492211-8837/$ - see front matter &amp; 2012 Fellowship of Postgraduate Medicine. Published by Elsevier Ltd. All rights reserved.England was created to deliver local Information Technologysolutions as part of the NHS Care Records Service. Englandwas initially divided into ve geographic areas, each of whichwould work together to take forward the procurement and</p><p>doi:10.1016/j.hlpt.2012.01.004</p><p>E-mail addresses: wendy.currie@fpm-uk.orgmarket mechanisms in healthcare service delivery [1,2].Publicprivate partnerships are developing to provide citi-zens with greater choice in healthcare products and services[3,4]. The impetus behind this is partly because of burgeon-ing healthcare budgets with OECD countries annuallyspending anywhere between 5% and 16% of Gross DomesticProduct on healthcare, with an average between 8% and 9%[5]. Secondly, while healthcare technology in the EuropeanUnion is considered a low maturity sector compared withnance and manufacturing, spending on information and</p><p>traditional medical professionalism to a patient-centredapproach. Health tourism is increasing with new productsand services supported by a range of enabling and emergingtechnologies, i.e. telemedicine, mobile devices to alertpatients about appointments, prescriptions and test results [9].</p><p>Prior research shows that introducing healthcare technol-ogies is high risk where potential and realised benets aredifcult to measure [10]. Unintended outcomes are notuncommon, particularly in large-scale publicly funded ICTprojects that fail to meet expectations. For example, theThe global healthcare industry is changing in three importantareas. Firstly, politicians are exploring alternative ap-</p><p>market for ICTs also extends to medical devices and imagingequipment [7] as these technologies are becoming increas-ingly converged [8]. Thirdly, citizens are encouraged to takeIntroduction(future) technologies in healthcare. An integrative model for health technology assessment isdeveloped from prior empirical research, secondary source material and peer review on a rangeof healthcare technologies: information and communications technology; medical devices,imaging/monitoring technology; personalised medicines; drug discovery and diagnostics. TheTEMPEST model is an acronym for technology, economic, market, political, evaluation, socialand transformation. These themes are sub-divided into focal areas, where quantitativeindicators/metrics are used for comparative analysis. The model provides a conceptual andanalytical tool for policy-makers, healthcare professionals IT vendors, citizens and otherstakeholders for understanding and evaluating the scale and scope of health technologyadoption and implementation at national, regional and local levels.&amp; 2012 Fellowship of Postgraduate Medicine. Published by Elsevier Ltd. All rights reserved.</p><p>estimated to be between 5% and 8% of GDP [6]. The growingThis paper responds to calls for a national forum to track enabling (current) and emergingjournal homepage: ww</p><p>TEMPEST: An integrative mtechnology assessment</p><p>Wendy L. Currie</p><p>Editor-in-Chief, Health Policy and Technology, Fellowship ofAvailable online 8 February 2012lsevier.com/locate/hlpt </p><p>del for health</p><p>stgraduate Medicine, London, UK</p></li><li><p>and technical factors [12]. TEMPEST thus adopts a multi-dimensional and integrative approach to understanding thecomplexities and challenges of introducing healthcaretechnologies. It aims to provide a useful HTA tool forpolicy-makers and communities of practice engaged inhealth service delivery.</p><p>W.L. Currie36implementation of the NHS Care Records Service at a locallevel. These comprised of the: Eastern, North East, NorthWest and West Midlands, London, and Southern clusters. In2007, responsibility for local delivery of the NPfIT wasdevolved to Strategic Health Authorities (SHAs). England wasthen divided into only three Programme for IT regions eachwith its own Local Service Provider. In 2011, a decision wasagain taken to restructure the NPfIT as SHAs were beingdisbanded. This would allow for more choice and decen-tralisation of IT services, rather than the original top-down,centralised approached of the previous decade. Following allthese changes, the UK coalition government in the autumn of2011 decided to completely rethink the NPfIT, although thiswill necessitate a renegotiation of contractual terms withleading IT and management consulting rms. This change ofgovernment policy has resulted in media reports that healthtechnology in the NHS is in total disarray, as the aim ofproviding citizens with full access to their electronic healthrecords remains a vision rather than a reality. By 31 March2011, total expenditure on the Programme totalled some6.4 billion [11].</p><p>Other cases in Europe, i.e. the European Health Card(EHC) implementation in Germany and the 2012 HospitalsPlan in France aimed at reorganising regional healthcareservices, upgrading hospitals to meet safety standards andintroducing new IT systems in hospitals have also incurredproblems, not only of a technical nature but also politically,organisationally and culturally. Health technology assess-ment (HTA) is not only a technical issue, but also needs to beunderstood within a larger, socio-political and economiccontext, where stakeholders often have different prioritiesand interests.</p><p>In recent years, the challenge to transform healthcaredue to rising costs and increased demand continuesunabated. Health technologies are seen to play a majortransformational role [8]. Yet whether they are introducedcentrally by government planning, or through regional orlocal initiatives, i.e. at the hospital level, remains acontentious issue. While the former has advantages ofeconomies of scale (i.e. procurement contracts), standardi-sation, and interoperability, the latter is more likely toachieve the political buy-in of clinicians, hospital adminis-trators and patients, especially if these groups have beeninvolved in the decision-making process from an early stage.The scientic research agenda should therefore focus onidentifying and learning from best practice examples inhealth technology adoption and diffusion at national,regional and local levels. Scientic research should addressthe wide ranging interests of stakeholders so that policiesand plans for introducing transformational change usingtechnology meets the needs of health professionals,patients and the community at large.</p><p>The TEMPEST methodology responds to calls to develop aninternational forum to track emerging and enablingtechnologies and their potential for diffusion intohealthcare environments. This forum is more likely to beeffective if it is built on evidence-based research whichserves as a resource-base available to multiple stakeholdersengaged in the policy, design and implementation of healthtechnologies. Prior research indicates the outcomes ofintroducing new technologies into healthcare organisationsare mixed due to poor policy making, management practiceTEMPEST: an integrative model</p><p>The TEMPEST1 methodology leverages its unique frameworkof 7 themes, 21 sub-themes and 84 (coded) quantitativeindicators to deliver evidence-based insights that addressscientic and policy issues (see Appendix A). This isreinforced by an inter-disciplinary, multi-dimensional modelof health technology assessment (HTA) that allows thoseapplying it to analyse specic health technologies, orrelated issues, from a market, political, commercial,stakeholder or individual perspective, through a national,regional, local or organisational lens. So far, TEMPEST hasbeen applied to the 27 European Union Member Stateswhere data can be compared at the EU and national levels.Incorporating key EU policy priorities, such as encouragingactive and healthy ageing, preventive medicine and healthylifestyles, improving citizens health security, reducinghealth inequalities, and promoting and disseminating healthinformation [13] TEMPEST offers an integrative approachwhere data points can be compared and contrasted to showbenets and barriers in health technology adoption anddiffusion.</p><p>HTA is a multi-disciplinary process which aims to informthe development of effective health policies that are:(i) patient-focused; (ii) market- and consumer-friendly, and(iii) deliver optimal value and outcomes to all stakeholdersinvested in public health. As a research approach, it focuseson information about the medical, social, economic andethical issues related to the use of a health technology, aswell as the short- and long-term consequences of its use, ina systematic, transparent, unbiased and robust manner.However, the different academic perceptions and practicesof what constitutes HTA raise concerns about the adequacyof evaluation methods. The siloed approach to HTA wherestudies isolate the economic, organisational or culturalaspects of specic health technologies leads to observationsthat ythe striking nding from our review (of healthtechnology) is that there has been so little solid evaluationof these (EHR) applications [10]. Others comment that,When technologies are disruptive, operating and nancialimpacts are challenging to estimate, which makes itdifcult to construct a business case for investmentydisruptive technologies make it difcult to conduct return-on-investment (ROI) analyses [8]. So gathering quantitativeand/or qualitative data on selected health technologieswithout considering the wider socio-political, organisationaland ethical issues is a futile exercise [14,15]. It is also</p><p>1This paper introduces the TEMPEST methodology and discussesits rationale in relation to the wider health technology literature. Ithas currently been applied to 27 EU Member States, although spacelimitations preclude its further discussion and analysis in this paper.Future issues of Health Policy and Technology will include cross-country comparisons of TEMPEST data points to give examples ofcurrent and potential benets and barriers.</p></li><li><p>relevant stakeholder communities, not least patients andtheir representative groups.</p><p>The scale and scope of health technology is a further</p><p>TEMPEST: An integrative model for health technology assessment 37apparent that, while there are serious structural barriersto the use of IT that have nothing to do with technolo-gyylegal and nancial incentives provide little motivationto share information across institutions, which is critical toimproving patient outcomes as well as efciency [16].</p><p>Scientic research has shown the emphasis in theapplication of HTA has primarily focused on clinical aspectsof health technologies, rather than economic, patient-related, and organisational aspects. There are some notableexceptions. Danish HTAs, for example, have a wider scopecompared with HTAs in other countries, as patient-relatedand organisational dimensions are included [17]. EvaluatingHTA institutions in nine countries (Australia, Canada, Den-mark, Netherlands, New Zealand, Norway, Sweden, UK andUSA) the authors found that Denmark and Sweden scoredhighest for including organisational issues, with the USAscoring lowest. In the case of the latter, organisational,economic and patient aspects were given less attention withthe inclusion of a limited number of questions. Economicissues were more frequently included than patient issuesand this order of priority was fairly consistent for all HTAinstitutions. Policy recommendations were also usuallyomitted from HTA reports. Conclusions suggest that reportswhich omit wider aspects have dubious value for decision-making, and there is a vital need for further research [17].</p><p>With regard to health technologies, monitoring data shouldtherefore be sufciently robust for HTA to inform optimal useof technology [12]. An evidence-based approach to HTA canoffer decision makers data and information about the optimalor sub-optimal use of health technology. Evidence fromnational or regional studies where organisational and socialindicators, for example, are not integrated into HTA, are lesslikely to provide a robust evaluation of clinical and costeffectiveness. For certain complex technologies (such as ICTsand medical devices), providing evidence about the expectedimpact of a technology on health system structures,processes, and resources is valuable within the HTA exerciseas it can contribute to the development of an effectiveimplementation plan. However, the potential choice ofrelevant indicators, and the need to harmonise evidence fordecision-making, adds further complexity to HTA. A debate istherefore needed to identify key quantitative and qualitativemeasures, metrics and indicators for HTA, as this is importantnot only for benchmarking the adoption and use of healthtechnologies, but also for policy-making.</p><p>Integral to the TEMPEST methodology is a multi-disciplinary,cross-national, and diverse health technology landscape, whichutilises and extends prior work on HTA within a structured andthemed framework. TEMPESTaggregates health and technologyindicators from a wide range of reputable data sources, tocontribute to state-of-the-art research by building on priorresearch that addresses health policy priorities. The pragmaticrationale for TEMPEST is to create a cross-disciplinary,integrative model aimed to bring together disparateacademic communities in clinical and social science. Forexample, academic researchers in health policy, healthinformatics, health management and health sciences, tendto publish their ndings in specic academic outlets (i.e.academic journals and conference proceedings) whichreect disciplinary silos. This offers limited opportunitiesfor knowledge sharing, as dissemination of common issues inhealth policy and technology needs to be shared with allcomplexity. ICTs, medical devices, imaging/monitoringtechnology, personalised medicines, drug discovery anddiagnostics, all impact on clinical and non-clinical stake-holder groups. This suggests that a common language needsto be found to enable these diverse groups to communicatewith each other. As prior research has shown, the introduc-tion of technologies in healthcare settings has producedmixed results as technologies are in various stages of theirmaturity life cycle, with untried and untested emergingtechnologies posing the most risk. Even where technologiesare perceived to highly mature, they may not have deliveredexpected benets, measured by an adequate return-on-investment. For example, electronic medical records (EMRs)were rst introduced as early as the 1960s, yet their useacross the international healthcare landscape is patchy, withmany clinicians experiencing problems of inadequate pa-tient data (i.e. missing and/or incorrect). Paper-basedrecords continue to be widespread, as th...</p></li></ul>


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