Avaliação da Usabilidade de um Projeto de eHealth, enquadrado na visão europeia de Health Technology Assessment (HTA)

Trabalho de projeto apresentado à Escola Superior de Comunicação Social como parte dos requisitos para obtenção de grau de mestre em Audiovisual e Multimédia.

L'health technology assessment per l'acquisizione di tecnologie sanitarie

La diffusione nelle strutture sanitarie di un numero sempre crescente di apparecchiature biomediche e di tecnologie "avanzate" per la diagnosi e la terapia ha radicalmente modificato l'approccio alla cura della salute. Questo processo di "tecnologizzazione" rende evidente la necessità di fare ricorso a competenze specifiche e a strutture organizzative adeguate in modo da garantire un’efficiente e corretta gestione delle tecnologie, sia dal punto di vista tecnico che economico, bisogni a cui da circa 40 anni risponde l’Ingegneria Clinica e i Servizi di Ingegneria Clinica. Nei paesi industrializzati la crescita economica ha permesso di finanziare nuovi investimenti e strutture all'avanguardia dal punto di vista tecnologico, ma d'altra parte il pesante ingresso della tecnologia negli ospedali ha contribuito, insieme ad altri fattori (aumento del tenore di vita, crescente urbanizzazione, invecchiamento della popolazione, ...) a rendere incontrollabile e difficilmente gestibile la spesa sanitaria. A fronte quindi di una distribuzione sempre più vasta ed ormai irrinunciabile di tecnologie biomediche, la struttura sanitaria deve essere in grado di scegliere le appropriate tecnologie e di impiegare correttamente la strumentazione, di garantire la sicurezza dei pazienti e degli operatori, nonché la qualità del servizio erogato e di ridurre e ottimizzare i costi di acquisto e di gestione. Davanti alla necessità di garantire gli stessi servizi con meno risorse è indispensabile utilizzare l’approccio dell’Health Technology Assessment (HTA), ossia la Valutazione delle Tecnologie Sanitarie, sia nell’introduzione di innovazioni sia nella scelta di disinvestire su servizi inappropriati od obsoleti che non aggiungono valore alla tutela della salute dei cittadini. Il seguente elaborato, dopo la definizione e classificazione delle tecnologie sanitarie, un’analisi del mercato di tale settore e delle spesa sanitaria sostenuta dai vari paesi Ocse, pone l’attenzione ai Servizi di Ingegneria Clinica e il ruolo chiave che essi hanno nel garantire efficienza ed economicità grazie anche all’ausilio dei profili HTA per la programmazione degli acquisti in sanità.

SWISSspine—a nationwide health technology assessment registry for balloon kyphoplasty: methodology and first results

The Swiss Federal Office of Public Health demanded a nationwide health technology assessment registry for cervical and lumbar total disc arthroplasty and for balloon kyphoplasty (BKP) to make a decision about reimbursement of these interventions.

Effectiveness, safety and cost-effectiveness of homeopathy in general practice - summarized health technology assessment

Introduction: The Health Technology Assessment report on effectiveness, cost-effectiveness and appropriateness of homeopathy was compiled on behalf of the Swiss Federal Office for Public Health (BAG) within the framework of the 'Program of Evaluation of Complementary Medicine (PEK)'. Materials and Methods: Databases accessible by Internet were systematically searched, complemented by manual search and contacts with experts, and evaluated according to internal and external validity criteria. Results: Many high-quality investigations of pre-clinical basic research proved homeopathic high-potencies inducing regulative and specific changes in cells or living organisms. 20 of 22 systematic reviews detected at least a trend in favor of homeopathy. In our estimation 5 studies yielded results indicating clear evidence for homeopathic therapy. The evaluation of 29 studies in the domain 'Upper Respiratory Tract Infections/Allergic Reactions' showed a positive overall result in favor of homeopathy. 6 out of 7 controlled studies were at least equivalent to conventional medical interventions. 8 out of 16 placebocontrolled studies were significant in favor of homeopathy. Swiss regulations grant a high degree of safety due to product and training requirements for homeopathic physicians. Applied properly, classical homeopathy has few side-effects and the use of high-potencies is free of toxic effects. A general health-economic statement about homeopathy cannot be made from the available data. Conclusion: Taking internal and external validity criteria into account, effectiveness of homeopathy can be supported by clinical evidence and professional and adequate application be regarded as safe. Reliable statements of cost-effectiveness are not available at the moment. External and model validity will have to be taken more strongly into consideration in future studies.

Traditional chinese medicine (phytotherapy): health technology assessment report - selected aspects

Objective: A summary of main aspects from a Health Technology Assessment report on Traditional Chinese Medicine (TCM) in Switzerland concerning effectiveness and safety is given. Materials and Methods: Literature search was performed through 13 databases, by scanning reference lists of articles and by contacting experts. Assessed were quality of documentation, internal and external validity. Results: Effectiveness: 43 articles concerning 'gastrointestinal tract and liver' were assessed. The studies covering 7,436 patients were undertaken in China (35), Japan (3), USA (2) and Australia (3); 33/43 being controlled studies. 34/40 show significantly better results in the TCM-treated group. A comparison of studies on results of treatment based on a diagnosis according to TCM criteria and studies on results of treatment according to Western diagnosis shows that treatment based on TCM diagnosis improves the result. The comparison of treatment by individual medication and standard medication showed a trend in favor of individual medication. Safety: TCM training and practice for physicians in Switzerland are officially regulated. Side effects occur, but no severe effects have been registered up to now in Switzerland. TCM medicinals are imported; admission regulations are being installed. Problems due to production abroad, Internet trade, self-medication or admixtures are possible. Conclusion: The evaluation of the literature search provides evidence for a basic clinical effectiveness of TCM therapy. Severe side effects were not observed in Switzerland. Regulations for trading and use of medicinals prevent treatment risks. Further clinical studies in a Western context are required.

SWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses

SWISSspine is a so-called pragmatic trial for assessment of safety and efficiency of total disc arthroplasty (TDA). It follows the new health technology assessment (HTA) principle of "coverage with evidence development". It is the first mandatory HTA registry of its kind in the history of Swiss orthopaedic surgery. Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. During the time between March 2005 and 2008, 427 interventions with implantation of 497 lumbar total disc arthroplasties have been documented. Data was collected in a prospective, observational multicenter mode. The preliminary timeframe for the registry was 3 years and has already been extended. Data collection happens pre- and perioperatively, at the 3 months and 1-year follow-up and annually thereafter. Surgery, implant and follow-up case report forms are administered by spinal surgeons. Comorbidity questionnaires, NASS and EQ-5D forms are completed by the patients. Significant and clinically relevant reduction of low back pain VAS (70.3-29.4 points preop to 1-year postop, p < 0.0001) leg pain VAS (55.5-19.1 points preop to 1-year postop, p < 0.001), improvement of quality of life (EQ-5D, 0.32-0.73 points preop to 1-year postop, p < 0.001) and reduction of pain killer consumption was revealed at the 1-year follow-up. There were 14 (3.9%) complications and 7 (2.0%) revisions within the same hospitalization reported for monosegmental TDA; there were 6 (8.6%) complications and 8 (11.4%) revisions for bisegmental surgery. There were 35 patients (9.8%) with complications during followup in monosegmental and 9 (12.9%) in bisegmental surgery and 11 (3.1%) revisions with 1 [corrected] new hospitalization in monosegmental and 1 (1.4%) in bisegmental surgery. Regression analysis suggested a preoperative VAS "threshold value" of about 44 points for increased likelihood of a minimum clinically relevant back pain improvement. In a short-term perspective, lumbar TDA appears as a relatively safe and efficient procedure concerning pain reduction and improvement of quality of life. Nevertheless, no prediction about the long-term goals of TDA can be made yet. The SWISSspine registry proofs to be an excellent tool for collection of observational data in a nationwide framework whereby advantages and deficits of its design must be considered. It can act as a model for similar projects in other health-care domains.

TECHNOLOGY ASSESSMENT: SMALL-VOLUME INFUSION PUMPS

"Technology assessment is a comprehensive form of policy research that examines the short- and long-term social consequences of the application or use of technology" (US Congress 1967).^ This study explored a research methodology appropriate for technology assessment (TA) within the health industry. The case studied was utilization of external Small-Volume Infusion Pumps (SVIP) at a cancer treatment and research center. Primary and secondary data were collected in three project phases. In Phase I, hospital prescription records (N = 14,979) represented SVIP adoption and utilization for the years 1982-1984. The Candidate Adoption-Use (CA-U) diffusion paradigm developed for this study was germane. Compared to classic and unorthodox curves, CA-U more accurately simulated empiric experience. The hospital SVIP 1983-1984 trends denoted assurance in prescribing chemotherapy and concomitant balloon SVIP efficacy and efficiency. Abandonment of battery pumps was predicted while exponential demand for balloon SVIP was forecast for 1985-1987. In Phase II, patients using SVIP (N = 117) were prospectively surveyed from July to October 1984; the data represented a single episode of therapy. The questionnaire and indices, specifically designed to measure the impact of SVIP, evinced face validity. Compeer group data were from pre-SVIP case reviews rather than from an inpatient sample. Statistically significant results indicated that outpatients using SVIP interacted socially more than inpatients using the alternative technology. Additionally, the hospital's education program effectively taught clients to discriminate between self care and professional SVIP services. In these contexts, there was sufficient evidence that the alternative technology restricted patients activity whereas SVIP permitted patients to function more independently and in a social lifestyle, thus adding quality to life. In Phase III, diffusion forecast and patient survey findings were combined with direct observation of clinic services to profile some economic dimensions of SVIP. These three project phases provide a foundation for executing: (1) cost effectiveness analysis of external versus internal infusors, (2) institutional resource allocation, and (3) technology deployment to epidemiology-significant communities. The models and methods tested in this research of clinical technology assessment are innovative and do assess biotechnology. ^

The Role of decision-analytic modelling in German health technology assessments

BACKGROUND: Decision-analytic modelling (DAM) has become a widespread method in health technology assessments (HTA), but the extent to which modelling is used differs among international HTA institutions. In Germany, the use of DAM is optional within HTAs of the German Institute of Medical Documentation and Information (DIMDI). Our study examines the use of DAM in DIMDI HTA reports and its effect on the quality of information provided for health policies. METHODS: A review of all DIMDI HTA reports (from 1998 to September 2012) incorporating an economic assessment was performed. All included reports were divided into two groups: HTAs with DAM and HTAs without DAM. In both groups, reports were categorized according to the quality of information provided for healthcare decision making. RESULTS: Of the sample of 107 DIMDI HTA reports, 17 (15.9%) used DAM for economic assessment. In the group without DAM, conclusions were limited by the quality of economic information in 51.1% of the reports, whereas we did not find limited conclusions in the group with DAM. Furthermore, 24 reports without DAM (26.7%) stated that using DAM would likely improve the quality of information of the economic assessment. CONCLUSION: The use of DAM techniques can improve the quality of HTAs in Germany. When, after a systematic review of existing literature within a HTA, it is clear that DAM is likely to positively affect the quality of the economic assessment DAM should be used.

Health benefits of pets : summary of working group : NIH Technology Assessment Workshop, September 10-11, 1987.

Shipping list no.: 88-461-P.

Environmental health risk assessment of dioxin in foods and the sustainability of public health interventions at severe dioxin hot spots in Vietnam

This study assessed environmental health risk from dioxin in foods and sustainability of risk reduction programs at two heavily contaminated former military sites in Vietnam. The study involved 1000 household surveys, analysis of food samples and in-depth discussions with residents and officials. The findings indicate that more than 40 years after the war, local residents still experience high exposure to dioxin if they consume local high risk foods. Public health intervention programs were rated moderately to well sustained. Internal migration, and lack of clear, official guidance and sensitivity regarding dioxin issues were the main challenges for sustainability of prevention programs.

Body loadings and health risk assessment of polychlorinated dibenzo-p-dioxins and dibenzofurans at an intensive electronic waste recycling site in China

This study is one of the very few investigating the dioxin body burden of a group of child-bearing-aged women at an electronic waste (e-waste) recycling site (Taizhou, Zhejiang Province) (24 +/- 2.83 years of age, 40% were primiparae) and a reference site (Lin'an city, Zhejiang Province, about 245 km away from Taizhou) (24 +/- 2.35 years of age, 100% were primiparae) in China. Five sets of samples (each set consisted of human milk, placenta, and hair) were collected from each site. Body burdens of people from the e-waste processing site (human milk, 21.02 +/- 13.81 pg WHO-TEQ(1998/g) fat (World Health Organization toxic equivalency 1998); placenta, 31.15 +/- 15.67 pg WHO-TEQ(1998/g) fat; hair, 33.82 +/- 17.74 pg WHO-TEQ(1998/g) dry wt) showed significantly higher levels of polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurnas (PCDD/Fs) than those from the reference site (human milk, 9.35 +/- 7.39 pg WHO-TEQ(1998/g) fat, placenta, 11.91 +/- 7.05 pg WHO-TEQ(1998/g) fat; hair, 5.59 +/- 4.36 pg WHO-TEQ(1998/g) dry wt) and were comparatively higher than other studies. The difference between the two sites was due to e-waste recycling operations, for example, open burning, which led to high background levels. Moreover, mothers from the e-waste recycling site consumed more foods of animal origin. The estimated daily intake of PCDD/Fs within 6 months by breast-fed infants from the e-waste processing site was 2 times higher than that from the reference site. Both values exceeded the WHO tolerable daily intake for adults by at least 25 and 11 times, respectively. Our results implicated that e-waste recycling operations cause prominent PCDD/F levels in the environment and in humans. The elevated body burden may have health implications for the next generation.