Core competencies for ethics experts in health technology assessment.

OBJECTIVES: There 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. METHODS: Based 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. RESULTS: Expertise 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. CONCLUSIONS: The competencies described here can be used by HTA agencies and others involved in HTA to call attention to and strengthen ethical analysis in HTA.

Ethics analysis of light and vitamin D therapies for seasonal affective disorder.

OBJECTIVE: The aim of this ethics analysis was to highlight the overt and covert value issues with regard to two health technologies (light therapy and vitamin D therapy), the health technology assessment (HTA) and the disease of seasonal affective disorder (SAD). The present ethics analysis served as a chapter of a full HTA report that aimed to assist decision makers concerning the two technologies. METHOD: First, we used the revised Socratic approach of Hofmann et al. to build overarching topics of ethical issues, and then, we conducted a hand search and a comprehensive systematic literature search on between 12 and 14 February 2019 in seven databases. RESULTS: The concrete ethical issues found concerned vulnerability of the target population and the imperative to treat depressive symptoms for the sake of preventing future harm. Further disease-related ethical issues concerned the questionable nature of SAD as a disease, autonomy, authenticity, and capacity for decision making of SAD patients, and the potential stigma related to the underdiagnosis of SAD, which is contrasted with the concern over unnecessary medicalization. Regarding the interventions and comparators, the ethical issues found concerned their benefit-harm ratios and the question of social inequality. The ethical issues related to the assessment process relate to the choice of comparators and the input data for the selected health economic studies. CONCLUSIONS: The concrete ethical issues related to the interventions, the disease, and the assessment process itself were made overt in this ethics analysis. The ethics analysis provided an (additional) value context for making future decisions regarding light and vitamin D therapies.

Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment.

AIM: To summarize the evidence on the clinical effectiveness and safety of coronary sinus reducing stent (CSRS) therapy in refractory angina pectoris (AP) patients. METHODS: We performed a systematic literature search in common databases (n=4). The evidence obtained was summarized according to GRADE methodology. A health technology assessment (HTA) was conducted using the HTA Core Model® for Rapid Relative Effectiveness Assessment. Primary outcomes for the clinical effectiveness domain were the proportion of patients with improvement in two or more Canadian Cardiovascular Society (CCS) angina score classes, overall mean reduction of CCS class, and Seattle Angina Questionnaire (SAQ) quality of life (QoL) score improvement. Outcomes for the safety domain were adverse device effects (ADEs) and serious adverse device effects (SADEs). RESULTS: One randomized controlled trial (RCT) was identified. Outcomes that showed statistically significant differences between CSRS and sham treatment (in favor of CSRS) were CCS angina score improvement of one or two classes, overall mean reduction of CCS class, and SAQ QoL score improvement. Concerning safety, the sham-controlled trial data indicate that there were fewer SADEs in the intervention group (19%) than in the control group (46%). SADEs reported in observation studies ranged from none to 30%. The most frequently reported SADEs were death and stable angina. In the RCT, the only case of death occurred in the control group. Concerning clinical effectiveness, the risk of bias (RoB) was rated to be low, and concerning safety, the RoB was rated to range from low to moderate. As assessed by GRADE, the overall strength of evidence for effectiveness and safety was moderate. Internal and external validity of the evidence base were low. CONCLUSION: Even though the current evidence indicates that the assessed technology, CSRS, is potentially more effective than sham intervention for refractory AP patients, the lack of internal validity of the studies undermines the partially positive results.

Minimum volume standards in day surgery: a systematic review.

BACKGROUND: The aim was to find out if and for what indications are minimum volume standards (MVS) applied in the day surgery setting and whether the application of MVS improves patient relevant outcomes. METHODS: We conducted a comprehensive systematic literature search in seven databases on July 12th, 2019. Concerning effectiveness and safety, the data retrieved from the selected studies were systematically extracted into data-extraction tables. Two independent researchers (MS, CS) systematically assessed the quality of evidence using the quality assessment tool for individual studies of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) called Task Force Checklist for Quality Assessment of Retrospective Database Studies. No instances of disagreement occurred. No further data processing was applied. RESULTS: The systematic literature search, together with hand search, yielded 595 hits. No prospective or controlled studies were found. Data from eight retrospective studies were used in the analysis of clinical effectiveness and safety on seven indications: anterior cruciate ligament reconstruction, cataract surgery, meniscectomy, thyroidectomy, primary hip arthroscopy, open carpal tunnel release, and rotator cuff repair. All interventions (except for carpal tunnel release and thyroidectomy) confirmed a volume-outcome relationship (VOR) with relation to surgeon/hospital volume, however, none established MVS for the respective interventions. Safety related data were reported without its relationship to surgeon/hospital volume. CONCLUSIONS: This present paper provides some evidence in favor of the VOR, however, it based on low quality retrospective data-analyses. The present results cannot offer any clear-cut MVS thresholds for the day surgery setting and so the simple transition from inpatient results (that support MVS) to the day surgery setting is questionable. Further quality assuring policy approaches should be considered.

Neonatology in Austria: ethics to improve practice.

In the world of Austrian neonatal intensive care units, the role of ethics is recognized only partially. The normatively tense cases that are at the backdrop of this essay concern the situations around the limit of viability (weeks 22 + 0 days to 25 + 6 days of gestation), which is the point in the development of an extremely preterm infant at which there are chances of extra-uterine survival. This essay first outlines the key explicit ethical challenges that are mainly concerned with notions of uncertainty and best interest. Then, it attempts to elucidate the less explicit ethical challenges related to the notion of nudging in the neonatal practice and argue that the role of ethics needs to be recognized more-with the focus on the role of virtue ethics-in order to improve the practice of neonatal medicine.

The impact of external trigeminal nerve stimulator (e-TNS) on prevention and acute treatment of episodic and chronic migraine: A systematic review.

OBJECTIVE: The aim of this systematic review was to analyze the effectiveness and safety of the external trigeminal nerve stimulator (eTNS) for the prevention and acute treatment of migraine attacks in episodic and chronic migraine patients. METHODS: We have conducted a systematic literature search in four databases that yielded 433 citations and additional seven citations were found via hand-search. Two randomised placebo-controlled trials and five prospective case series were included in the analysis. RESULTS: Concerning prevention, statistically significant differences were found with respect to reduction of migraine attacks (0.67 less migraine attacks per month), migraine days (1.74 less migraine days per month), headache days (2.28 less headache days per month), and acute antimigraine drug intake (4.24 less instances of acute drug intake per month). Concerning acute treatment, statistically significant differences were found with respect to pain reduction on a visual analogue scale at 1/2/24 h post-acute treatment (1.68/1.02/1.08 improvement, respectively). No serious adverse events occurred in any of the studies. CONCLUSIONS: While e-TNS has the potential to improve migraine symptoms, for its establishment in the standard practice, high quality comparative data, studies with larger sample sizes, and studies with standard and relevant primary outcome parameters are needed.

Efficacy and safety assessment of lymphovenous anastomosis in patients with primary and secondary lymphoedema: A systematic review of prospective evidence.

INTRODUCTION: Lymphoedema is a chronic, debilitating condition caused by an affected lymphatic system. Supermicrosurgical techniques like lymphovenous anastomosis (LVA) have gained popularity because of its minimal invasiveness, better aesthetic outcome, and lower costs in comparison to physical medicine. This systematic review aims to evaluate the clinical effectiveness and safety of LVA in comparison to conservative or other surgical treatments for primary or secondary lymphoedema patients. MATERIALS AND METHODS: A systematic literature search was performed in four databases in December 2017. We applied a methodological framework based on the HTA Core Model®. According to the grading of recommendations, assessment, development, and evaluation (GRADE) scheme, we synthesized the data on each selected outcome category. The studies were systematically assessed for risk of bias (RoB) using the Risk of Bias Assessment tool for Non-randomized controlled studies (RoBANS) and the Institute of Health Economics (IHE) Risk of Bias checklist for case series. RESULTS: A total of 629 citations were identified and five studies were assessed eligible for final inclusion (one non-randomized controlled trial and four prospective single-arm studies). Across the studies, 217 patients were enrolled. All studies showed a moderate to high RoB. The strength of evidence for the effectiveness and safety of LVA is "very low." Due to the methodological shortcomings of the available evidence, no conclusions can be made about the effectiveness of the procedure. CONCLUSION: LVA might be a safe technique for patients with primary and secondary lymphoedema-particularly because no serious complications were reported. Furthermore, LVA may have a role in the prevention of lymphoedema.

Decision-making at the limit of viability: the Austrian neonatal choice context.

BACKGROUND: We aimed to explore the shared decision-making context at the limit of viability (weeks 22-25 of gestation) through analyzing neonatologist's communication strategies with parents and their possible impact on survival and neurodevelopmental impairment (NDI) outcomes. METHODS: A mixed methods approach was applied where a systematic literature search and in-depth semi-structured interviews with five heads of neonatology departments and one clinical ethicist from the Austrian context were integrated into a literature review. The aim was to identify decision practice models and the choice context specific to Austria. RESULTS: Professional biases, parental understanding, and the process of information giving were identified as aspects possibly influencing survival and NDI outcomes. Institutions create self-fulfilling prophecies by recommending intensive/palliative care based upon their institutional statistics, yet those vary considerably among high-income countries. Labelling an extremely preterm (EP) infant by the gestational week was shown to skew the estimates for survival while the process of information giving was shown to be subject to framing effect and other cognitive biases. CONCLUSION: Communication strategies of choice options to parents may have an impact on the way parents decide and hence also on the outcomes of EP infants.

The status of health economic evaluation within decision making in Austria.

BACKGROUND: Given limited resources compared to the demand for them, spending resources efficiently is important. Key methods applied for supporting efficient resource allocation are health economic evaluations. METHODS: Based on secondary literature, we analyze international challenges for using two types of economic evaluations-cost-effectiveness analysis and cost-utility analysis-in reimbursement decisions and reflect on them for the Austrian case. RESULTS: The main challenges with the application of economic evaluations are related to the methods, the decision-making culture, and the respective system. The challenges also apply to the Austrian Bismarck system, where almost no formal requirements for using economic evaluations exist, except on a case-by-case basis. Resource allocation in Austria hence occurs, for the most part, implicitly. CONCLUSION: One way forward towards more explicit efficiency considerations may be to consider more descriptive study types and foster capacity building, standardization of methods and presentation of results, and a mandatory detailed guideline.

Nudging in Neonatology: Practical Wisdom and Accountability for Reasonableness.

OBJECTIVES: The way choice is presented has an impact on decision-making. This is the case also in the context of neonatal intensive care units (NICUs), particularly in the challenging cases that concern the limit of viability. The objective of this article is to examine the role of nudging in the shared decision-making in neonatology and elaborate on the respective moral challenges. RESULTS: Nudging is not morally neutral. There are two key sources of ethical issues at the heart of nudging. The first one concerns the lack of transparency, while the second concerns the background value judgments that are imminent whenever nudging is used for achieving a particular end. To solve the underlying conflict, a virtue ethics approach combined with the accountability for reasonableness framework is suggested to guide the use of the tool of nudging. CONCLUSIONS: NICU professionals ought to use the tool of nudging transparently in line with their act of profession and their practically wise judgment.

Professional ethics: the case of neonatology.

Neonatal professionals encounter many ethical challenges especially when it comes to interventions at the limit of viability (weeks 22-25 of gestation). At times, these challenges make the moral dilemmas in neonatology tragic and they require a particular set of intellectual and moral virtues. Intellectual virtues of episteme and phronesis, together with moral virtues of courage, compassion, keeping fidelity to trust, and integrity were highlighted as key virtues of the neonatal professional. Recognition of the role of ethics requires a recognition that answering the obvious question (what shall we do?) does not always suffice. Acknowledging the tragic question (is any of the alternatives open to us free from serious moral wrongdoing) and recognizing the ethical dilemmas, where the lines between right and wrong are blurred, leads to actions taken towards establishing ethics frameworks to support decision-making. In neonatology units, such organizational support can help in allowing the team members to recognize the ethical dilemmas, avoid moral distress, and improve team cohesion and the quality of care provided. Only when the organizational structure allows ethical dilemmas to be recognized, adequate decisions can be made.

Methods to detect inappropriate use of MRI and CT for musculoskeletal conditions: A scoping review.

OBJECTIVE: Identify and evaluate methods suitable for detecting inappropriate use of MRI or CT in the musculoskeletal system. DESIGN: Systematic review of studies that described methods to measure inappropriate use of MRI or CT in the musculoskeletal system. We used a multi-step strategy to classify identified methods into categories. These categories were then analyzed according to the data needed and their limitations. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: English or German language studies that measured inappropriate use of MRI or CT in the musculoskeletal system. Articles were also included if they reported a general approach to the measurement of inappropriate imaging regardless of body region. Expert opinions, unsystematic reviews, commentaries, articles without abstracts, and studies on cancer were excluded. RESULTS: 47 studies met the inclusion criteria. The categorization of the studies resulted in seven individual approaches to measure inappropriate use: (1) availability of meaningful diagnostic information; (2) predictors associated with imaging use; (3) comparison with guideline recommendations; (4) assessment by experts; (5) comparison or analysis of patients' paths; (6) comparison with surgery findings; (7) geographic variation. All these approaches have specific data requirements and individual advantages and disadvantages regarding risk of bias and needed data. CONCLUSIONS: We could not find a single method of choice to detect inappropriate use of MRI or CT in the musculoskeletal system. A combination of different approaches is the preferred strategy to deal with the advantages and disadvantages of the individual methods.

Novel Surgical Treatments for Gastroesophageal Reflux Disease: Systematic Review of Magnetic Sphincter Augmentation and Electric Stimulation Therapy.

Electric stimulation therapy (EST) and magnetic sphincter augmentation (MSA) represent novel methods for the surgical treatment of gastroesophageal reflux disease (GERD). The aim of this review was to assess the effectiveness and safety of EST and magnetic sphincter augmentation device (MSAD) comapred to laparoscopic fundoplication (LF) and proton pump inhibitor therapy (in case of EST). We performed a systematic literature search without restrictions on publication dates in five electronic databases (MEDLINE, EMBASE, the Cochrane library, PubMed, and Centre for Reviews and Dissemination), complemented by hand search, search in trial registries, and documentation provided by the manufacturers. No study passed inclusion criteria for analyzing EST effectiveness. Concerning safety, lead erosion through the esophagus and trocar perforation of the small bowel occurred in 2.4% of patients (in one study). Only the registry study fulfilled inclusion criteria for effectiveness analysis of MSAD. The crucial outcome of GERD-health-related quality of life (HRQL) score improved from 20 to 3 points in MSAD patients, and from 23 to 3.5 points in LF patients. However, the LF patients were in a more severe stage of the disease. The results yield indefinite conclusions about the use of both MSAD and EST. Clinical effectiveness and safety of both MSAD and EST are not sufficiently proven and are yet to be supported by high quality evidence from randomized controlled trials.

Nudging in screening: Literature review and ethical guidance.

OBJECTIVES: Nudging is the purposeful alteration of choices presented to people that aims to make them choose in predicted ways. While nudging has been used to assure high uptake and good outcome of screening programs, it has been criticized for being paternalistic, undermining free choice, and shared decision making. Accordingly, the objective of this study is to explore a) nudging strategies identified in screening, b) arguments for and against nudging; and on basis of this, to c) suggest a tentative conclusion on how to handle nudging in screening. METHODS: Literature searches in Ovid MEDLINE and PsycINFO for combinations of screening and nudging. Screening based on content analysis of titles, abstracts, and articles. RESULTS: 239 references were identified and 109 were included. Several forms of nudging were identified: framed information, default bias, or authority bias. Uptake and public health outcome were the most important goals. Arguments for nudging were bounded rationality, unavoidability, and beneficence, while lack of transparency, crowding out of intrinsic values, and paternalism were arguments against it. The analysis indicates that nudging can be acceptable for screenings with (high quality) evidence for high benefit-harm ratio (beneficence), where nudging does not infringe other ethical principles, such as justice and non-maleficence. In particular, nudging should not only focus on attendance rates, but also on making people "better choosers." PRACTICE IMPLICATIONS: Four specific recommendations follow from the review and the analysis: 1) Nudging should be addressed in an explicit and transparent manner. 2) The means of nudging have to be in proportion to the benefit-harm ratio. 3) Disagreement on the evidence for either benefits or harms warrants special care. 4) Assessing and assuring the intended outcome of nudging appears to be crucial, as it can be context dependent.

Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study.

AIM: To summarize the evidence on clinical effectiveness and safety of wearable cardioverter defibrillator (WCD) therapy for primary and secondary prevention of sudden cardiac arrest in patients at risk. METHODS: We performed a systematic literature search in databases including MEDLINE via OVID, Embase, the Cochrane Library, and CRD (DARE, NHS-EED, HTA). The evidence obtained was summarized according to GRADE methodology. A health technology assessment (HTA) was conducted using the HTA Core Model® for rapid relative effectiveness assessment. Primary outcomes for the clinical effectiveness domain were all-cause and disease-specific mortality. Outcomes for the safety domain were adverse events (AEs) and serious adverse events (SAEs). A focus group with cardiac disease patients was conducted to evaluate ethical, organizational, patient, social, and legal aspects of the WCD use. RESULTS: No randomized- or non-randomized controlled trials were identified. Non-comparative studies (n=5) reported AEs including skin rash/itching (6%), false alarms (14%), and palpitations/light-headedness/fainting (9%) and discontinuation due to comfort/lifestyle issues (16-22%), and SAEs including inappropriate shocks (0-2%), unsuccessful shocks (0-0.7%), and death (0-0.3%). The focus group results reported that experiencing a sense of security is crucial to patients and that the WCD is not considered an option for weeks or even months due to expected restrictions in living a "normal" life. CONCLUSION: The WCD appears to be relatively safe for short-to-medium term, but the quality of existing evidence is very low. AEs and SAEs need to be more appropriately reported in order to further evaluate the safety of the device. High-quality comparative evidence and well-described disease groups are required to assess the effectiveness of the WCD and to determine which patient groups may benefit most from the intervention.