Health Technology Assessment (HTA) is a systematic study of the effect and consequences of the use of a particular technology in a defined context (6). The aim is to produce objective knowledge for decision makers on the benefits, costs, and harms of a technology so that the healthcare system can be based on relevant evidence. Appraising evidence and making decisions on the use of healthcare resources is, however, never a straightforward process. Social and ethical values and identification of the various consequences of implementing a new technology play an important role in the final decision. An in-depth ethical evaluation within an HTA report provides a more profound understanding of the various aspects that need to be taken into account during the decision-making process (10).
The fledgling methods of eliciting ethical issues relevant to a health technology assessment topic are not well described; neither does a generally accepted method exist. The International Network of Agencies for Health Technology Assessment (INAHTA) survey in 2003 revealed that, of the thirty-six member organizations that replied, 47 percent included ethical issues in their assessments (11). Moreover, the methods for evaluation and written conclusions differed markedly between the various organizations.
Structured questions as suggested by Hofmann (11) are helpful but not applicable to every situation. Neither do they reflect the actual assessment questions that surface directly in discussions between methodological and clinical experts. Ethical evaluation within HTA requires creative collaboration between various professionals—experts in HTA methodology, content, and ethics. Within this continuously developing field of health technology assessment, ethical evaluation needs a variety of approaches tailored to each particular technology.
In this article, we use “ethics” as a generic term for the various ways of understanding and examining the moral life (4). Every society creates norms that reflect its values. These norms form the basis for laws and moral rules that protect the individuals from harming each other. Some rules are made explicit in the form of regulations; others remain implicit but are nonetheless followed. Normative ethics tells us how life ought to be. Non-normative ethics studies how people reason and act and tries to understand what the life factually is. Within a profession, the non-normative ethics may differ markedly between various specialties: such as for instance with the attitude toward follow-up and care of patients with nontreatable diseases within medicine. Healthcare decisions based on rules, norms, and evidence of effectiveness are also influenced by the personality and moral responses of the persons making the decisions.
In Finohta, we have developed a framework for ethical evaluation when assessing different types of interventions. Each HTA report is produced in cooperation with the methodological experts from Finohta and clinical experts from healthcare organizations. Professional ethicists are today consulted during the HTA process when it is considered necessary, but they are always included in the peer review process. In this study, we present four examples of ethical evaluations included in our projects, of which three have been completed (1;3;12).
GENERAL FRAMEWORK FOR AN ETHICAL EVALUATION AT FINOHTA
Decision points for ethical evaluation during the HTA process in Finohta are presented in Table 1. The focus within the topic, the specific questions to be answered, and the definition of the primary outcome are defined by the assessment team. These value-laden choices have a major impact on the content and conclusions of the HTA report.
General and technology-specific ethical issues and consequences for various stakeholders can be identified during the HTA process. For each stakeholder, we have listed possible consequences of proceeding with or refraining from the implementation of the technology (as compared with other options). Ethical evaluation has multiple perspectives and should ideally be produced by persons genuinely representing each stakeholder. An exchange of opinions, weighing different values and searching for the common good is the core of a successful ethical discussion.
New ethical issues often emerge during the HTA process, when the assessment team learns more of the detail of the technology through literature and in discussions with professionals using the technology. Therefore, it is necessary to repeat the ethical appraisal process a few times during the assessment. Novel aspects may come up even at the final comment round. No matter how minor an ethical aspect may seem, it should be presented once it has emerged. This strategy may slow down the process unexpectedly.
The report is approved by the entire assessment team. Ethical evaluation is written as a separate chapter but its main aspects are interwoven in the discussion chapter so that evidence is balanced against ethical consequences.
Ethical aspects can be highlighted or downplayed when HTA results are publicized. The media can have a different view of their importance than professionals or the assessment group. Finally, when the effects of a report are evaluated, the ethical discussion prompted by it can be a major result in itself.
The following four examples of ethical evaluations of HTA projects at Finohta started during 2003–04. Two projects assessed screening (1;3), one an invasive procedure (12), and the one still ongoing looks at rehabilitation.
SCREENING FOR RARE METABOLIC DISORDERS
Many countries base their screening for rare metabolic disorders on finding phenylketonuria (PKU). Because PKU is a rarity (15) in the Finnish population, the only metabolic disorder screened for during the neonatal period in Finland is congenital hypothyreosis from umbilical cord blood. A suggestion to start a local pilot study screening for a wide range of metabolic disorders was planned. Before this screening, an HTA project was started to evaluate the cost-effectiveness of expanding the screening and implementing tandem mass spectrometry. The assessment pointed out that this new technology would require building a totally new screening organization for the sake of finding five to ten babies with a rare disorder annually (1;2).
The various ethical concerns were elicited using a cross-tabulation of stakeholders and situations with and without screening (Table 2). The content changed during the evaluation process as some of the possible risks were eliminated but new ones emerged. In this project, a lack of research and consequently of evidence led to problems, as it became clear that high quality research evidence may never be gathered for rare disorders. This matter was further discussed by the national screening committee, which decided not to recommend screening for rare disorders, mainly due to the lack of direct evidence on effectiveness.
PRENATAL SCREENING FOR STRUCTURAL AND CHROMOSOMAL ABNORMALITIES
Methods for fetal screening have developed rapidly, and many countries commonly offer screening to all pregnant women. Women may even consider screening as a routine check-up during pregnancy (13;14); thus a suspicion of fetal abnormalities or facing difficult decisions based on the screening results may come as a surprise. The implementation of screening has been partly driven by technological development and may thus fail to reflect the current values and goals of society.
In Finland, each community can choose which screening methods they offer to their inhabitants. This has led to wide differences in practice. Finohta was asked to identify optimal methods for screening for structural and chromosomal abnormalities. The working group repeatedly considered the ethical consequences of screening for chromosomal and structural abnormalities during the project. This group also used an open tabulation of stakeholders and consequences of various screening methods. The ethical issues were discussed in detail within the report and a summary of the overall analysis is presented in Table 3.
The iterative and thorough ethical evaluation resulted in a questioning of the values and moral justice behind screening for fetal abnormalities. The main areas of ethical disagreement were classified into four sets of questions, and an open discussion among stakeholders was requested before formulating a national policy. The questions were focused on (i) the aims of screening for chromosomal abnormalities, (ii) the aims of screening for structural malformations, (iii) decision on screening methods, and (iv) quality control. A set of questions is presented in Table 4. An open seminar to discuss the report after its publication was organized, recruiting over 300 participants from laypersons to health decision makers.
Based on the report (3) and also the consultation round and seminar discussions, the national screening committee has proposed to the Ministry of Health a uniform national screening system to improve quality and equity of care, offering parents full freedom to select between four options: (i) not to attend any fetal screening tests; (ii) to attend screening only for features that support good care of pregnancy (due date, number of fetuses, and so on), (iii) to attend screening for fetal abnormalities (chromosomal and/or structural) with the option for termination of pregnancy if severe abnormalities are detected, or (iv) to attend ultrasound screening for structural abnormalities in late pregnancy (when termination is no longer an option) to arrange optimal conditions for delivery and care of the newborn.
INVASIVE TREATMENTS IN CORONARY HEART DISEASE
This assessment looked at the effectiveness of invasive interventions in treating coronary heart disease, prompted by the observation that practice increasingly favored the use of drug eluting stents and an increase in patients in need of acute care in Finland. This expert group included cardiologists, a cardiac surgeon, and methodological experts. The primary outcomes were avoidance of reoperations and death; these were analyzed from systematic reviews. Clinically important differences in effectiveness between the studied interventions—open heart surgery, angioplasty with or without stent, drug eluting stent, or fibrin-specific thrombolytic agents, depending on the condition—could not be observed (12). This result was not readily accepted by the external experts.
In this group, ethical evaluation was introduced to the clinical expert group when the effectiveness of the chosen interventions had already been partly assessed. This timing proved to be too late. The clinical experts did not consider opening a discussion on ethical values as important. A decision to promote one of the evaluated interventions could, however, have major consequences on the organization of health care and might lead to inequalities in care. Finohta thus decided to invite another group of health policy makers and professional ethicists to discuss the ethical aspects. This group considered the ethical evaluation relevant and important. Due to time constraints, the ethical evaluation was restricted to identifying questions that need to be resolved together with all stakeholders before changing current practice. Discussion focused especially on the equity of care, both nationally and regionally, between patients with the same and different health problems. A summary of this discussion is presented in Table 5.
REHABILITATION OF CHILDREN WITH CEREBRAL PALSY
This ongoing HTA project on the effectiveness of physical therapy for children with cerebral palsy (CP) turned out to be especially difficult for several reasons. High quality research is sparse, and the new method suggested for evaluating the level of evidence in CP research (5) does not follow the rules generally accepted in evidence-based medicine (7). Clinical practice within rehabilitation is strongly influenced by opinion leaders. Major differences in the type and amount of the recommended individual therapies exist both within one country and between nations
To facilitate discussion during expert group meetings, we used an open grid, where the rows and columns were collectively named to represent various stakeholders and types of problems. Table 6 shows the current discussion regarding three stakeholders. The expert group also identified risks inherent in the HTA assessment using the method presented by Hailey and Juzwishin (8). Risk evaluation turned out to be very useful, and during this process entirely new ethical aspects were identified.
DISAGREEMENT DURING ETHICAL EVALUATION
The values and moral views of the persons assessing the technology influence also the ethical evaluation. Although no single solution to every moral problem exists, dialogue promotes understanding. During ethical evaluations, we have faced several situations of disagreement (Table 7), two of which are presented here in more detail.
In Finland, the blood sample for screening hypothyreosis is taken from the umbilical cord not from the heel of the newborn. The heel sample is painful for the baby; the umbilical cord sample is not. This issue was discussed in detail during the project. Of interest, a recent Dutch report (9) on the ethical consequences of expanding screening for newborn disorders had not identified this issue as ethically relevant as the heel prick test has been a practice for decades in the Netherlands.
A genuine moral dilemma was identified during the ethical evaluation of screening for fetal abnormalities. In Finland, it is legally possible to have an abortion up to the end of week 24 if a severe malformation is verified. The definition of a severe malformation is, however, not precise. One child with Down syndrome may have several structural malformations, visual and hearing impairment. Another child with Down syndrome may, however, be only mildly mentally retarded without any additional disabilities. The expert group and the open seminar discussed extensively whether and when Down syndrome diagnosed during pregnancy can be defined as being a severe malformation.
DISCUSSION
In a doctor–patient relationship, evidence cannot override the need for acknowledging individual patient values. Vice versa, values never replace missing knowledge. The same holds for health technology assessment. Conclusions of the effectiveness of an intervention may be misleading if used alone. If ethical evaluation is not included in the process, we may miss essential aspects of the technology. Even when the effects, costs, and harms of a technology are reported and appraised objectively, a thorough ethical evaluation may additionally enhance the dissemination of the HTA report and affect its implementation (3;11).
We found our eclectic approach, using a structured framework, to be a very helpful tool in opening ethical discussion in each HTA project. The groups tackled different types of interventions (screening, surgical intervention, rehabilitation), while their ways of reporting the ethical evaluation differed. The original framework designed for a screening assessment could be applied as a basis. It was repeatedly modified according to the specific features of each assessment.
Our expert groups were able to open vivid discussions on ethical values within society and the intervention in question. The clinical experts found the processes of ethical evaluation both important and rewarding. Their bias typically stems from seeking a benefit for their own patients; they may overlook the effects of implementing an intervention on other parties. The methodological experts may overlook the equity consequences or fail to recognize the restrictions of the included studies in relation to all patients with a similar condition. Neither might be aware of the historical background of current practice and the needs of patients.
Ethical evaluation is a continuous process that tries to understand the prevalent moral, values, and behavioral models of society. Each profession creates its own ethical rules and regulations that are the basis for their profession; these combine knowledge, experience, and commitment to ethically acceptable goals. It is important that the differences in non-normative ethics between various specialties within health care are also identified to improve equity in care. With the help of an in-depth ethical evaluation framework, it is possible to help the decision makers capture the wide consequences that implementing a new health technology has on individual citizens, the healthcare system, and society.
CONTACT INFORMATION
Ilona Autti-Rämö, MD, PhD (ilona_autti-ramo@stakes.fi), Department of Pediatric Neurology, Helsinki University Central Hospital, Lastenlinnantie 2, 00250 Helsinki, Finland; Senior Medical Officer, Finnish Office for Health Technology Assessment (FINOHTA), STAKES (National R & D Centre for Welfare and Health), P.O. Box 220, 00531 Helsinki, Finland
Marjukka Mäkelä, MD, PhD, M.Sc (marjukka.makela@stakes.fi), Professor (20%), Department of General Practice, University of Copenhagen, P.O. Box 2099, 1014 Copenhagen K, Denmark; Director, Finnish Office for Health Technology Assessment (FINOHTA), STAKES (National R & D Centre for Welfare and Health), P.O. Box 220, 00531 Helsinki, Finland
