Background
The development of large data sets, including genomic data, coupled with rapid advances in personalized medicine where citizens increasingly face complex choices about the use of their ...genomic information implies that citizens are essential stakeholders in genomics. They should be engaged in the ethical, legal and societal issues to produce a framework that fosters trust and allows them to guide the technology based on their values.
Objective
This article highlights that citizens' conceptions of the human genome inform about and make sense of their main values regarding the use of genomic information, which is critical for policymakers, experts and stakeholders to understand to maintain the public support in genomics.
Method
Through an inductive thematic approach, we reanalysed data collected for the Belgian citizen forum, which aimed to produce recommendations for the Ministry of Public Health and other stakeholders.
Results
Citizens expressed four conceptions of the genome that determined which uses of genomic information they supported: the most intimate part of individuals; ‘I am more than my genome’; the individual's property vs the common good; and uncertainty and fear.
Conclusion
Diversity in their conceptions reveals remaining conflicts of values among citizens, mainly regarding a conception of the genome as an individual property or a common good. However, despite differing conceptions, shared values emerged such as solidarity, privacy, no genetic discrimination and the right to an open future, where individual and common interests coexist.
Patient or public contribution
The panel of the citizen forum consisted of 32 citizens.
One consequence of the legal diversity in Europe is that legal restrictions on treatments can be evaded by going abroad. Many French lesbian couples and single women are crossing the border to ...Belgium because they are denied access to treatments with donor sperm at home. This is the first qualitative research study into the experiences and moral perspectives of these women. Between June 2012 and May 2013, 11 lesbian couples and 2 single women were recruited at the department of reproductive medicine at Ghent University Hospital. The data from the semi-structured interviews was analysed using inductive thematic analysis. The results show that these women face several additional challenges to the already difficult process of cross-border treatment. Before they can start the treatment, they can only obtain information from the internet or from stories of friends who also went abroad for treatment with donor sperm. During the treatment, they need to find local clinics or physicians to monitor their cycle. Several women managed to game the French system to ensure partial reimbursement for their treatment when they were successful in finding a physician who was willing to prescribe drugs and perform tests. Most women had difficulties justifying their absence from work. In general these women felt that they were discriminated against and that their rights were not protected because of who they are. In that regard, the lack of legal recognition of the genetically unrelated partner in their country was particularly hard to cope with for the lesbian couples. These women have to develop many different strategies to deal with the difficulties they face during cross-border reproductive care. It is concluded that it is very important that they find a physician who is willing to support them in their 'baby project'.
To investigate the efficacy of interventions for the prevention and treatment of low back pain in nurses.
Systematic review.
The review was registered on the PROSPERO database (CRD42015026941) and ...followed the PRISMA statement guidelines. A two phase approach was used. In phase one, all randomised controlled trials included in the systematic review of Dawson et al. (2007) which reviewed interventions for low back pain in nurses until 2004 were selected. In phase two, relevant randomised controlled trials and cluster randomised controlled trials published from 2004 until December 2015 were identified by an electronic search of nine databases (Embase, CINAHL, SPORTDiscus, PsycARTICLES, Cochrane Library, Web of Science, PEDro, Scopus and MEDLINE). To be eligible, trials had to examine the efficacy of interventions either for the prevention or treatment of low back pain in nurses. Primary outcomes of interest were any measure of pain and/or disability.
Three reviewers independently assessed eligibility and two reviewers independently conducted a risk of bias assessment (Cochrane Back and Neck Group).
Four studies were retrieved from phase one. In phase two, 15,628 titles and abstracts were scanned. From these, 150 full-text studies were retrieved and ten were eligible. Fourteen studies (four from phase one, ten from phase two) were eligible for risk of bias assessment. The included trials were highly heterogeneous, differing in pain and disability outcome measures, types of intervention, types of control group and follow-up durations. Only four of the included studies (n=644 subjects) had a low risk of bias (≥6/12). Manual handling training and stress management in isolation were not effective in nurses with and without low back pain (risk of bias, 7/12, n=210); the addition of a stretching exercise intervention was better than only performing usual activities (risk of bias, 6/12, n=127); combining manual handling training and back school was better than passive physiotherapy (risk of bias, 7/12, n=124); and a multidimensional intervention (risk of bias, 7/12, n=183) was not superior to a general exercise program in reducing low back pain in nurses.
Only four relevant low risk of bias randomised controlled trials were found. At present there is no strong evidence of efficacy for any intervention in preventing or treating low back pain in nurses. Additional high quality randomised controlled trials are required. It may be worth exploring the efficacy of more individualised multidimensional interventions for low back pain in the nursing population.
Abstract
Objective
Persistent low back pain (PLBP) is a common and costly health problem worldwide. Better strategies to manage it are required. The purpose of this study was to longitudinally ...evaluate absenteeism, pain, and disability in nurses with PLBP following a cognitive functional therapy (CFT) intervention.
Methods
In this case series pilot study, 33 eligible nurses with PLBP were recruited. During the baseline phase (phase A; no intervention), outcome measures were collected on 2 occasions 6 months apart (A1 and A2). During phase B, participants received an individualized CFT intervention for 14 weeks. During phase C (no intervention), outcomes were measured immediately after the intervention, as well as 3, 6, 9, 12, and 36 months after the intervention (secondary outcomes only until 12 months). LBP-related work absenteeism, pain intensity (numerical pain rating scale) and disability (Oswestry Disability Index) were the primary outcomes. Health care seeking, a range of psychological and lifestyle variables, and global perceived effect were secondary outcomes.
Results
Days of absenteeism due to LBP were significantly reduced in the first and second calendar years after the CFT intervention but not the third and fourth. Disability was significantly reduced immediately after (−4.4; 95% CI = −6.5 to −2.2) and at 3 months (−4.3; 95% CI = −6.6 to −2.0), 9 months (−6.0; 95% CI = −8.1 to −3.9), and 12 months (−4.9; 95% CI = −7.0 to −2.8) after the intervention. Pain was significantly reduced immediately after (−1.2; 95% CI = −1.7 to −0.8) and at 3 months (−1.5; 95% CI = −2.0 to −0.9), 9 months (−1.1; 95% CI = −1.9 to −0.3), and 12 months (−0.9; 95% CI = −1.5 to −0.2) after the intervention. Total health care seeking (consults and proportion of participants) was significantly reduced after the intervention. All psychosocial variables, except for 1, demonstrated significant improvements at all follow-up assessments.
Conclusions
This case series pilot study demonstrated significant reductions in LBP-related absenteeism, pain intensity, disability, health care seeking, and several psychological and lifestyle behaviors until the 1-year follow-up among nurses with PLBP following an individualized CFT intervention. Further evaluation of the efficacy of CFT in high-quality randomized clinical trials among nurses is recommended.
Rights, preferences, needs and expectations of patients and citizens can only be respected and addressed if they are well understood. As such, a continuous, systematic and formalised dialogue between ...patients, citizens and policy makers is required to ensure ethical and socially appropriate cancer prevention, diagnostics, treatment and care. Relying on donations and project-based funding is not a sustainable way to ensure patient involvement and representativeness in policy. Patient organizations need long term, structural support to fulfil their role as patient representatives and support network in order to deliver the best possible service and to play their role as a professional representative of their disease-specific community. Inequalities can only be tackled if they are properly identified. This requires the definition of appropriate determinants fit for (inter)national comparison and extension and linkage of good quality data registries for cancer that allow the monitoring these inequalities.Rights, preferences, needs and expectations of patients and citizens can only be respected and addressed if they are well understood. As such, a continuous, systematic and formalised dialogue between patients, citizens and policy makers is required to ensure ethical and socially appropriate cancer prevention, diagnostics, treatment and care. Relying on donations and project-based funding is not a sustainable way to ensure patient involvement and representativeness in policy. Patient organizations need long term, structural support to fulfil their role as patient representatives and support network in order to deliver the best possible service and to play their role as a professional representative of their disease-specific community. Inequalities can only be tackled if they are properly identified. This requires the definition of appropriate determinants fit for (inter)national comparison and extension and linkage of good quality data registries for cancer that allow the monitoring these inequalities.
Public engagement is increasingly recognized as a mutual learning of perspectives between lay and expert stakeholders. Still, the intention to educate citizens sometimes prevails over an open and ...honest exchange. Because of this overemphasis on education, researchers may more easily label lay opinions invalid if uninformed or based on distorted beliefs. Our experience with uninformed and poorly informed (UPI) opinions in an online public engagement initiative (the DNA Debate) has taught us to think differently. First, UPI opinions might be ethically instructive, provided that one searches for the implicit message participants try to convey related to their values, fears, or needs. Since there will always be less informed or uninformed citizens, that would avoid rejecting their voices. Second, UPI opinions may highlight misconceptions in the general population for which more targeted education is necessary. This article is an invitation to reflect ethically on why and how researchers should deal with UPI opinions, illustrated by quotes from the DNA Debate.
The European Health Data Space (EHDS) aims to make the primary use of health data for healthcare provision more continuous, effective, and (cost) efficient. Moreover, it pursues to facilitate the ...secondary use of health data for purposes such as research, innovation, and policy making. In the context of secondary use, the EHDS legislative proposal (published on 3 May 2022) argues that Member States should develop Health Data Access Bodies (HDABs) whose responsibilities include facilitating the secondary use of health data, issuing data permits, and implementing high levels of accountability and security. In Belgium, the setup in 2023 of a federal Health Data Agency (HDA) that is developing and implementing a policy strategy and framework for the secondary use of health data, aligns well with the responsibilities set out for HDABs. Even though the EHDS aspires the empowerment of citizens, for instance by giving them access to their health data and control over the healthcare professionals who can consult these data, this call for citizen empowerment resonates less loudly regarding secondary use. We think, however, that elaborating and implementing citizen engagement in the domain of secondary use is required to align secondary use with socio-ethical sensitivities, preferences, and values and to provide social legitimacy and ethical solidity to a health data governance system. When implementing the EHDS legislation on a national level, the Belgian HDA and the future HDABs in general might be excellent opportunities to realise this ambition of citizen involvement and empowerment. More specifically, we urge HDABs, firstly, to expand the field of citizen engagement towards the domain of secondary use and, secondly, to respect and facilitate the diversity of citizen engagement. This would offer citizens genuine, continuous and diversified possibilities of involvement and co-creation concerning the development of a solid ethical governance framework for health data. Keywords: European Health Data Space, Health information, Health data, Secondary use, Citizen engagement
Since genomics is becoming commonplace in healthcare for the diagnosis, treatment, and prevention, the prospect of generating a genomic passport for all citizens is gaining traction. While this would ...have many advantages, it raises ethical issues requiring societal debate alongside academic reflection. Hence, Sciensano-the Belgian scientific Institute of Public Health-organised an online citizen engagement on genomic information usage, including a question on a genomic passport for all. The inductive thematic analysis of participants' contributions highlighted vulnerability as a fundamental concern, while this has not received sufficient attention so far in genomics. Participants expressed their vulnerability in two ways. First, the genomic passport would inform them about their ontological vulnerability. By revealing their constitutional weaknesses (predisposition to diseases), it reminds them that everyone is unavoidably and perennially at risk of being harmed. Second, the misuse of the genomic passport can add situational vulnerabilities (e.g., discrimination causing psychological and economic harm). Moreover, the fundamental uncertainty in genomics-how will such sensitive information be used, and how will the science evolve?-exacerbates these vulnerabilities. This article ends with recommendations to alleviate these vulnerabilities in genomics now and in the future in which the genomic passport may become a reality.
There is a general consensus about the underlying theoretical ethical principles that ground the practice of pediatric clinical trials: scientific necessity, good risk/benefit ratio, minimized ...burden, and parental consent/child assent. However, these principles are so broadly construed that it is not always clear how they should be applied in clinical practice. We conducted a qualitative study at Ghent University Hospital and the hospital of the Dutch-speaking university of Brussels on how researchers weigh ethical principles, assess the risk/benefit balance, estimate patient experience, and experience informed consent procedures in pediatric drug studies. Based on our assessment of the burden and risk versus benefit ratio in 62 pediatric drug research protocols, we selected 21 studies for further study to maximize diversity. Twenty-seven researchers (17 physicians, 10 study nurses) completed a qualitative survey about their study. We compared their responses to our assessments. The risk benefit assessment of our participants about their own research projects resembled our assessment almost perfectly. Assessing burden appeared to be more subjective. The researchers were confident in their ability to obtain valid consent. However, we question whether this confidence is warranted.
Conclusion
: We argue for constant ethical reflexivity in pediatric clinical trials, because broad ethical principles are not always easy to apply to specific situations.
What is Known:
•
Several international guidelines and a large body of scientific literature indicate a broad consensus about the basic ethical framework for pediatric clinical trials, based on risk benefit assessment and respect for autonomy.
•
Little is known about how researchers implement these broad principles in practice.
What is New:
•
Researchers’ risk/benefit assessments about their own studies resembled the assessment of neutral peers, assessing burden was more subjective.
•
Researchers were very confident in their ability to obtain valid informed consent.
In recent years, the linkage of survey data to health administrative data has increased. This offers new opportunities for research into the use of health services and public health. Building on the ...HISlink use case, the linkage of Belgian Health Interview Survey (BHIS) data and Belgian Compulsory Health Insurance (BCHI) data, this paper provides an overview of the practical implementation of linking data, the outcomes in terms of a linked dataset and of the studies conducted as well as the lessons learned and recommendations for future links. Individual BHIS 2013 and 2018 data was linked to BCHI data using the national register number. The overall linkage rate was 92.3% and 94.2% for HISlink 2013 and HISlink 2018, respectively. Linked BHIS-BCHI data were used in validation studies (e.g. self-reported breast cancer screening; chronic diseases, polypharmacy), in policy-driven research (e.g., mediation effect of health literacy in the relationship between socioeconomic status and health related outcomes, and in longitudinal study (e.g. identifying predictors of nursing home admission among older BHIS participants). The linkage of both data sources combines their strengths but does not overcome all weaknesses. The availability of a national register number was an asset for HISlink. Policy-makers and researchers must take initiatives to find a better balance between the right to privacy of respondents and society's right to evidence-based information to improve health. Researchers should be aware that the procedures necessary to implement a link may have an impact on the timeliness of their research. Although some aspects of HISlink are specific to the Belgian context, we believe that some lessons learned are useful in an international context, especially for other European Union member states that collect similar data. Keywords: Record linkage; data linkage, Health administrative insurance data, Health claims data, Health interview surveys
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