HTA can be described as a research-based, practice-oriented assessment of relevant evidence and knowledge on the direct and intended effects of healthcare technologies, as well as the indirect and unintended consequences (4). It is also viewed as a multidisciplinary field of policy analysis that studies the medical, ethical, social, and economic implications of the development, diffusion, and use of a health technology (5).

Objectives: Previous research has suggested people with impaired fasting glucose (IFG) are less likely to develop Type 2 diabetes (T2DM) if they receive prolonged structured diet and exercise advice. This study examined the within-trial cost-effectiveness of such lifestyle interventions.

Methods: Screen-detected participants with either newly diagnosed T2DM or IFG were randomized 2:1 to intervention versus control (usual care) between February and December 2009, in Norfolk (UK). The intervention consisted of group based education, physiotherapy and peer support sessions, plus telephone contacts from T2DM volunteers. We monitored healthcare resource use, intervention costs, and quality of life (EQ-5D). The incremental cost per quality-adjusted life-year (QALY) gain (incremental cost effectiveness ratio [ICER]), and cost effectiveness acceptability curves (CEAC) were estimated.

Results: In total, 177 participants were recruited (118 intervention, 59 controls), with a mean follow-up of 7 months. Excluding screening and recruitment costs, the mean cost was estimated to be £551 per participant in the intervention arm, compared with £325 in the control arm. The QALY gains were –0.001 and –0.004, respectively. The intervention was estimated to have an ICER of £67,184 per QALY (16 percent probability of being cost-effective at the £20,000/QALY threshold). Cost-effectiveness estimates were more favorable for IFG participants and those with longer follow-up (≥4 months) (ICERs of £20,620 and £17,075 per QALY, respectively).

Conclusions: Group sessions to prevent T2DM were not estimated to be within current limits of cost-effectiveness. However, there was a large degree of uncertainty surrounding these estimates, suggesting the need for further research.

Objectives: The aim of this study was to determine adults’ Willingness To Pay (WTP) for CardioVascular Disease (CVD) intervention programs of different intensities.

Methods: Three hundred fourteen participants were randomized to two study conditions: (i) CVD risk assessment/communication; (ii) CVD risk assessment/communication + a behavior change program. The behavior change program was aimed at increasing physical activity, reducing saturated fat intake and smoking cessation. It consisted of a tailored Web site and individual coaching with a self-selected dose. At post-assessment, WTP and perceived autonomy support items were included. The intervention dose was registered throughout the trial and post-hoc intervention dose groups were created. Pearson Chi-Square tests, Student's t-tests, one-way analyses of variance were used to examine WTP-differences between the study conditions and intervention dose groups.

Results: Twenty-four months after baseline, 61 and 135 participants of the control and intervention condition, respectively, completed the questionnaires. No WTP difference was found between the study conditions. However, participants that selected a higher intervention dose were willing to pay significantly more for their program (p < .05).

Conclusions: In general, people want to pay the same amount of money for a CVD prevention program, irrespective of the inclusion of a behavior change program. However, there seems to be an association between the self-selected dose of the latter program and the WTP.

Objectives: Recent introduction of a quadrivalent human papillomavirus (HPV) vaccine for girls in New Zealand is expected to decrease the incidence of HPV infection as well as resultant cytological abnormalities and cervical cancer. This may affect the cost-effectiveness of the national cervical screening program by reducing the incidence of lesions detected. This study investigates the cost-effectiveness of the current cervical screening policy with and without the HPV vaccine and compares these results with the cost-effectiveness of a range of other screening strategies.

Methods: A Markov state-transition model was built based on the natural history of HPV and cervical carcinogenesis. The model followed a hypothetical cohort of girls from 12 years to 85 years of age or death, through screening and treatment pathways. The model compared a “no vaccine and current screening” strategy with a selection of screening strategies with different age ranges and frequency intervals.

Results: The most cost-effective cervical screening strategy in the presence of the HPV vaccine would be screening women aged 30–60 every 5 years. Moving to this screening strategy from the base case of no vaccine and the current New Zealand strategy of screening women aged 20–69 every 3 years is predicted to have an incremental cost per quality-adjusted life-year gained of NZ$9,841 (€4,428).

Conclusions: Reducing screening intensity from 3 to 5 years as well as narrowing the screening age range for the vaccinated cohort once they reach mid-twenties is recommended. The importance of achieving a high vaccine uptake in New Zealand remains high.

Objectives: Immediate post-mastectomy breast reconstruction (IBR) is a procedure that has proven advantages, but it also entails risks. The aim of this study was to identify risk factors for reconstruction failure.

Methods: A review was made of all the IBR carried out at a general hospital from 2002 to 2009. Retrospective information was obtained about postoperative complications and the characteristics of patients and treatments applied. The minimum follow-up period was 9 months. Cox's regression analysis was performed on the variables related to the reconstruction failure requiring the removal of the prosthesis, with an explanatory model in which all the study variables were introduced and a predictive model that contained only the variables known before the intervention.

Results: A total of 115 IRB interventions carried out on 112 women with breast cancer were analyzed. The mean follow-up period was 25.5 months. In sixty cases (52.2 percent), there were no complications; in sixteen cases (13.9 percent) minor complications appeared, and in 39 (33.9 percent) the complications were moderate. In twenty-six cases (22.6 percent), a reconstruction failure occurred. Cox's regression model revealed that the reconstruction failures were related to the patient's age (Hazard Ratio 1.08), to neoadjuvant chemotherapy (HR 6.24) and to postoperative tamoxifen (HR 3.10). The predictive model included the age of the patient (HR 1.05) and the use of neoadjuvant chemotherapy (HR 5.11).

Conclusions: A significant proportion of the patients receiving IBR developed reconstruction failure. Multivariate analysis identified three variables related to this complication, two of which were known before the intervention.

Objectives: Ethical analysis can highlight important ethical issues related to implementing a technology, values inherent in the technology itself, and value-decisions underlying the health technology assessment (HTA) process. Ethical analysis is a well-acknowledged part of HTA, yet seldom included in practice. One reason for this is lack of knowledge about the properties and differences between the methods available. This study compares different methods for ethical analysis within HTA.

Methods: Ethical issues related to bariatric (obesity) surgery were independently evaluated using axiological, casuist, principlist, and EUnetHTA models for ethical analysis within HTA. The methods and results are presented and compared.

Results: Despite varying theoretical underpinnings and practical approaches, the four methods identified similar themes: personal responsibility, self-infliction, discrimination, justice, public funding, and stakeholder involvement. The axiological and EUnetHTA models identified a wider range of arguments, whereas casuistry and principlism concentrated more on analyzing a narrower set of arguments deemed more important.

Conclusions: Different methods can be successfully used for conducting ethical analysis within HTA. Although our study does not show that different methods in ethics always produce similar results, it supports the view that different methods of ethics can yield relevantly similar results. This suggests that the key conclusions of ethical analyses within HTA can be transferable between methods and countries. The systematic and transparent use of some method of ethics appears more important than the choice of the exact method.

Objectives: The role and impact of health technology assessment (HTA) in health policy has been widely discussed. Researchers have started to analyze how decisions on coverage of new technologies are made. Although the involvement of HTA may be an indicator of a well established decision process, this hypothesis requires validation. Also, it is not known whether HTA involvement is associated with other characteristics of decision making like participation or transparency. The primary objective of this study was to develop and test statements on the association between the publication of an HTA and coverage decision making for newborn screening tests in European Union countries.

Methods: Five statements were defined on the relative role of HTA during the steps of decision processes: trigger, participation, publication, assessment, and appraisal. For this purpose, data on twenty-two decision processes in the area of newborn screening across Europe were analyzed, defined as a coverage decision for a given disorder in a specific country. Decision processes were compared by whether the decision was accompanied by the publication of an HTA report. To test differences, nonparametric statistical tests were used.

Results: The decision steps of trigger, participation and publication differed between the HTA and the non-HTA groups. No clear association between HTA and assessment methods in coverage decision making was identified.

Conclusions: It appeared that there is an association between HTA and coverage decision processes that are more explicit, inclusive, and transparent. It is unclear whether HTA is associated with formal evidence reviews and economic evaluations.

Health systems are placing more and more emphasis on designing and delivering services that are focused on the patient, and there is a growing interest in patient aspects of health policy research and health technology assessment (HTA). Only a few HTA agencies use and invest in scientific methods to generate knowledge and evidence about the patient aspects of a given technology. This raises questions about how knowledge is produced in HTA reports and what kind of knowledge is considered relevant. This article uses a Danish HTA on patient education from 2009 as empirical material for a critical examination and discussion of knowledge and knowledge production about the patient aspects of HTA.

Objectives: The objective of this study is to describe how patient aspects are assessed in Danish HTA reports, thereby contributing to the ongoing international debates concerning patient aspects in HTAs.

Methods: Fifty-eight Danish HTA reports published from 1999 to 2010 were read systematically, focusing on the inclusion of patient aspects, the methods used to generate data, and if and how clinical recommendations concerning patient aspects were drawn.

Results: Most of the fifty-eight HTA reports had a separate chapter about patient aspects. All reports included literature reviews for patient aspects. There was, however, much variation in the ways in which the authors presented and discussed their review methods. The most frequently used databases for the literature search were medical and HTA databases. More than half of the reports included primary research, either quantitative or qualitative methods, a few used both kinds of methods. Whereas some mentioned the importance of including patient aspects in daily clinical practice, others provided ideas on how to improve patient information or recommended changes in healthcare practices.

Conclusions: Danish HTA reports do, to a large extent, include patient aspects in the assessment and in the final conclusions of the reports. If health policy and decision making is to be patient-focused, it is important that HTAs in the future integrate patient aspects in recommendations of HTA. Further improvement in assessments of patient aspects, in relation to use and description of methodologies and theoretical considerations, will assist producing the relevant evidence for these recommendations.

Objectives: The aim was to learn about perspectives of consumers contributing to the work of the Division of Research, Audit and Academic Surgery of the Royal Australasian College of Surgeons. The research arm of the Division has worked with consumers since it was formed in 1998.

Methods: Nine consumers who worked with the Division over the past 5 years completed (1) a written survey focused on their background and past experience, and (2) a semi-structured phone interview focused on their motivations for becoming involved in this work; their role; the evolution of the role of consumers in healthcare research; and what health information for consumers should contain.

Results: Participants came from various backgrounds and had different motivations for being involved. A common theme was concern about uncertainties in surgery and the need to provide consumers with information about potential benefits and risks of a procedure. Participants believed that a consumer presence was vital in research on surgical procedures, and that the content and wording of consumer information must be chosen carefully in order for the public to use it in a meaningful way. They also acknowledged the changing role of the consumer, who was rapidly becoming a partner in the doctor–patient relationship.

Conclusions: In surgical research and audit, the consumer perspective is unique and informed by a wealth of experience. The findings of this study may be of interest to other health technology assessment and associated agencies seeking to involve consumers within their own research process.

Objectives: This study comprises a review of public involvement strategies across the five stages of research management in the UK's HTA program at the end of a 10-year period. These five stages are: identification of topics; prioritization of these topics as researchable questions; commissioning of research; monitoring of projects throughout their implementation; and publication and dissemination of findings.

Methods: Internal HTA documentation was analyzed alongside narrative analysis of semi-structured interviews of program staff, and a rapid review of published literature.

Results: Public involvement strategies have developed with the growth of the HTA program but were spread unevenly across the five stages of research management. Public involvement was present in identification, strongest in prioritization, present in commissioning but minimal in monitoring and absent in publication and dissemination.

Conclusions: The HTA program has developed public involvement strategies but mainly in prioritization. Further research is required to ascertain where public involvement can be most appropriately used and to evaluate its impact.

Background: The Institute for Quality and Efficiency in Health Care (IQWiG) was established in 2003 by the German parliament. Its legislative responsibilities are health technology assessment, mostly to support policy making and reimbursement decisions. It also has a mandate to serve patients’ interests directly, by assessing and communicating evidence for the general public.

Objectives: To develop a priority-setting framework based on the interests of patients and the general public.

Methods: A theoretical framework for priority setting from a patient/consumer perspective was developed. The process of development began with a poll to determine level of lay and health professional interest in the conclusions of 124 systematic reviews (194 responses). Data sources to identify patients’ and consumers’ information needs and interests were identified.

Results: IQWiG's theoretical framework encompasses criteria for quality of evidence and interest, as well as being explicit about editorial considerations, including potential for harm. Dimensions of “patient interest” were identified, such as patients’ concerns, information seeking, and use. Rather than being a single item capable of measurement by one means, the concept of “patients’ interests” requires consideration of data and opinions from various sources.

Conclusions: The best evidence to communicate to patients/consumers is right, relevant and likely to be considered interesting and/or important to the people affected. What is likely to be interesting for the community generally is sufficient evidence for a concrete conclusion, in a common condition. More research is needed on characteristics of information that interest patients and consumers, methods of evaluating the effectiveness of priority setting, and methods to determine priorities for disinvestment.

Objectives: The aim of this study was to describe the process and challenges of developing a decision aid for the national public breast cancer screening program in Finland.

Methods: An expert team with stakeholder representation used European guidelines and other literature as basis for selecting relevant content and format for the decision aid for breast cancer screening. Feedback from women was sought for the draft documents.

Results: A decision aid attached to the invitation letter for screening was considered the best way to ensure access to information. In addition, tailored letter templates for all phases of the screening program, a poster, and a public website were developed. Initial feedback from users (women, professionals, and service providers), was mainly positive. Six months after publishing, the implementation of the decision aid was still incomplete.

Conclusions: Providing balanced information for women invited to breast cancer screening is demanding and requires careful planning. Professionals and service providers need to be engaged in the HTA process to ensure proper dissemination and implementation of the information. End user participation is essential in the formulation of information. There is a need to follow up the implementation of the decision aid.

Objectives: The aim of this study was to develop a breast cancer Patient Decision Aid (PDA), using a Health Technology Assessment (HTA) process, to assist patients in their choice of therapeutic options, and to promote shared decision making among patients, healthcare professionals, and other interested parties.

Methods: A systematic review (SR) was conducted of existing breast cancer patient Decision Aids encountered in the main scientific journal databases and on institutional Web sites that create PDAs, together with a Qualitative Research (QR) study, using semi-structured interviews and focus group with stakeholders (patients, family members, and health professionals), with the aim of developing a PDA for breast cancer.

Results: The SR shows that PDAs in breast cancer not only increase patient knowledge of the illness, leading to more realistic expectations of treatment outcomes, but also reduce passivity in the decision-making process and facilitate the appropriate choice of treatment options in accordance with patient medical and personal preferences. The analysis of QR shows that both breast cancer patients and healthcare professionals agree that surgery, adjuvant treatments, and breast reconstruction represent the most important decisions to be made. Worry, anxiety, optimism, and trust in healthcare professionals were determined as factors that most affected patients subjective experiences of the illness. This HTA was used as the basis for developing a PDA software program.

Conclusions: The SR and QR used in the development of this PDA for breast cancer allowed patients to access information, gain additional knowledge of their illness, make shared treatment decisions, and gave healthcare professionals a deeper insight into patient experiences of the disease.

Background: Patient involvement is widely acknowledged to be a valuable component in health technology assessment (HTA) and healthcare decision making. However, quantitative approaches to ascertain patients' preferences for treatment endpoints are not yet established. The objective of this study is to introduce the analytic hierarchy process (AHP) as a preference elicitation method in HTA. Based on a systematic literature review on the use of AHP in health care in 2009, the German Institute for Quality and Efficiency in Health Care (IQWiG) initiated an AHP study related to its HTA work in 2010.

Methods: The AHP study included two AHP workshops, one with twelve patients and one with seven healthcare professionals. In these workshops, both patients and professionals rated their preferences with respect to the importance of different endpoints of antidepressant treatment by a pairwise comparison of individual endpoints. These comparisons were performed and evaluated by the AHP method and relative weights were generated for each endpoint.

Results: The AHP study indicates that AHP is a well-structured technique whose cognitive demands were well handled by patients and professionals. The two groups rated some of the included endpoints of antidepressant treatment differently. For both groups, however, the same six of the eleven endpoints analyzed accounted for more than 80 percent of the total weight.

Conclusions: AHP can be used in HTA to give a quantitative dimension to patients' preferences for treatment endpoints. Preference elicitation could provide important information at various stages of HTA and challenge opinions on the importance of endpoints.

Objectives: The aim of this study, in the context of disinvestment related health technology assessment, is to examine whether analysis of Web 2.0—commercial media output, blogs, and discussion forums—can provide an understanding of media framing, community perspectives, and the sociopolitical aspects of an entrenched technology.

Methods: Thematic analysis of relevant data from fifty-nine media articles, thirty-nine discussion forums, thirteen blogs, and three Facebook pages relating to our case study: public funding for assisted reproductive technology services. Mainstream media and community-based social media responses were compared.

Results: Media responses were narrow, primarily describing emotive individual narratives or the political nexus of interests. Community (including patient) responses were broader including discussion of opportunity cost and vested interests but mostly reflected the polar ends of the debate, diverging strongly for or against disinvestment from public funding.

Conclusion: Web2.0 and media analysis offers an inexpensive method to capture media portrayal, divergent community responses both to that portrayal and independent of it, and insight into the sociopolitical aspects of an entrenched technology undergoing disinvestment debate.

Objectives: Synthesizing qualitative research is an important means of ensuring the needs, preferences, and experiences of patients are taken into account by service providers and policy makers, but the range of methods available can appear confusing. This study presents the methods for synthesizing qualitative research most used in health research to-date and, specifically those with a potential role in health technology assessment.

Methods: To identify reviews conducted using the eight main methods for synthesizing qualitative studies, nine electronic databases were searched using key terms including meta-ethnography and synthesis. A summary table groups the identified reviews by their use of the eight methods, highlighting the methods used most generally and specifically in relation to health technology assessment topics.

Results: Although there is debate about how best to identify and quality appraise qualitative research for synthesis, 107 reviews were identified using one of the eight main methods. Four methods (meta-ethnography, meta-study, meta-summary, and thematic synthesis) have been most widely used and have a role within health technology assessment. Meta-ethnography is the leading method for synthesizing qualitative health research. Thematic synthesis is also useful for integrating qualitative and quantitative findings. Four other methods (critical interpretive synthesis, grounded theory synthesis, meta-interpretation, and cross-case analysis) have been under-used in health research and their potential in health technology assessments is currently under-developed.

Conclusions: Synthesizing individual qualitative studies has becoming increasingly common in recent years. Although this is still an emerging research discipline such an approach is one means of promoting the patient-centeredness of health technology assessments.

Objectives: The aim of this study was to develop the GRIPP (Guidance for Reporting Involvement of Patients and Public) checklist to enhance the quality of PPI reporting.

Methods: Thematic analysis was used to synthesize key issues relating to patient and public involvement (PPI) identified in the PIRICOM and PAPIRIS systematic reviews. These issues informed the development of the GRIPP checklist.

Results: The key issues identified included limited conceptualization of PPI, poor quality of methods reporting, unclear content validity of studies, poor reporting of context and process, enormous variability in the way impact is reported, little formal evaluation of the quality of involvement, limited focus on negative impacts, and little robust measurement of impact. The GRIPP checklist addresses these key issues.

Conclusion: The reporting of patient and public involvement in health research needs significant enhancement. The GRIPP checklist represents the first international attempt to enhance the quality of PPI reporting. Better reporting will strengthen the PPI evidence-base and so enable more effective evaluation of what PPI works, for whom, in what circumstances and why.