International scope of biomedical research ethics review.

Many countries consider long-term implications for society.

How pregnant women with diabetes experience telemonitoring of the fetal heart rate - An interview study.

OBJECTIVES: The use of telemonitoring in healthcare is generally increasing. Women with complicated pregnancies are using telemonitoring as an alternative to conventional management, encompassing hospitalization or frequent outpatient clinic visits. However, there is sparse evidence on how pregnant women experience monitoring of their unborn babies at home. Women might feel uncomfortable with this responsibility, and moreover they might miss face-to-face contact with healthcare personnel. STUDY DESIGN: The study setting was a Danish hospital with a tertiary obstetric unit attending approximately 3400 births annually. A qualitative study design with interview as method included 11 pregnant women with type 1 diabetes or Gestational Diabetes Mellitus. This design was used to investigate how pregnant women with complicated pregnancies experienced telemonitoring of the fetus. Reflexive thematic analysis was used to analyze the pregnant women's experiences of telemonitoring. RESULTS: Women with type 1 diabetes or Gestational Diabetes Mellitus found the advantages of telemonitoring to outweigh the disadvantages. They experienced telemonitoring as time-saving and that telemonitoring decreased the level of stress. Moreover, telemonitoring supports positive collaboration with healthcare professionals. The women also experienced a lack of coordination of consultations between different departments at the hospital and challenges with timing, feedback, and technical issues. Moreover, the women requested an opportunity to discuss family formation and emotions. CONCLUSIONS: Pregnant women with type 1 diabetes or Gestational Diabetes Mellitus benefit from the use of telemonitoring. To further improve the implementation and use of telemonitoring clinical implications, consider how timing and coordination of care, technical equipment, and feedback mechanisms could be improved.

The relation between preterm birth and self-reported spinal pain in pre-adolescence-a study of 47,063 subjects from the Danish National Birth Cohort.

Repeated exposure to pain and stress in early life may cause alterations in pain sensitivity later in life. Children born preterm are often exposed to painful invasive procedures. This study aimed to explore the relationship between being born preterm and self-report of spinal pain in pre-adolescence. This prospective study was based on the Danish National Birth Cohort and consisted of 47,063 11-14-year-olds. Data from the Danish National Birth Cohort were linked with national registers through Statistics Denmark. Analyses were performed as multiple logistic regression models estimating odds ratios and 95% confidence intervals. Spinal pain (neck, mid back, and/or low back pain) was assessed using a subdivision of the Young Spine Questionnaire. Severe spinal pain was defined as having pain often or once in a while with an intensity of four to six on the Revised Faces Pain Scale. Inverse probability weighting was used to account for potential selection bias. Girls born very preterm (< 34 full weeks of gestation) were less likely to report spinal pain (OR: 0.60; 95% CI: 0.40-0.93) compared with those term-born. The associations were weaker when examining moderate to severe spinal pain and when examining the three spinal regions separately. None of these was statistically significant. CONCLUSION: We found no associations for boys. In conclusion, this study indicates that girls born very preterm are seemingly less likely to have severe spinal pain in pre-adolescence than girls born at term. WHAT IS KNOWN: • Spinal pain is one of the largest disease burdens globally, and the evidence regarding the etiology of spinal pain in children and adolescents is limited. • Repeated exposure to pain and stress in early life (i.e., being preterm) may cause alterations in pain sensitivity later in life. WHAT IS NEW: • Girls born very preterm (< 34 full weeks of gestation) seem less likely to report severe spinal pain in pre-adolescence compared with girls born at full term. • There is no association between gestational age and later experience of spinal pain in pre-adolescent boys.

Effect of an electronic reminder of follow-up screening after pregnancy complicated by gestational diabetes mellitus: a randomized controlled trial.

AIM: To determine the effectiveness of despatching an electronic reminder of participation in screening for gestational diabetes. The reminder was sent to the women 1-8 years after delivery. METHODS: A registry-based, randomized controlled trial in the North Denmark Region among women with gestational diabetes. Randomization was made, which included seven groups stratified by the child's birth year (2012-2018). The intervention group received standard care supplemented by an electronic reminder through a secure nationwide email system (n = 731), while the control group received only standard care (n = 732). The primary outcome was based on blood testing for diabetes (OGTT, HbA1c or fasting P-glucose). RESULTS: A total of 471 (32.1%) women participated in screening. The primary outcome was experienced by 257 women (35.1%) in the intervention group and 214 women (29.2%) in the control group. The effect of the reminder seemed to increase with recipient's age, non-western origin, urban dwelling, and multiparity. Of those who participated in follow-up screening, 56 (3.8%) were diagnosed with type 2 diabetes. CONCLUSION: Electronic reminders, based on the principles of informed choice and patient-centred care, to women have been shown to support life-long participation in follow-up screening. Attempts to further stimulation of coverage could however be considered. TRAIL REGISTRATION: ISRCTN registry (22/04/2022, ISRCTN23558707).

A kind reminder-A qualitative process evaluation of women's perspectives on receiving a reminder of type 2 diabetes follow-up screening after gestational diabetes.

RATIONALE, AIMS AND OBJECTIVES: Women with previous gestational diabetes mellitus (GDM) are more than eight times more likely to develop type 2 diabetes (T2DM) compared to women without GDM. Annual follow-up T2DM-screening is recommended, but participation rates decrease rapidly after the first year. In the North Denmark Region, an electronic reminder has been tested with the aim of improving follow-up care for women with prior GDM. The aim of this study was to explore women's perspectives on receiving an electronic reminder, and the role of reminders in both women's decision-making and informed choice regarding participation in follow-up screening. METHODS: A qualitative process evaluation informed by a critical realistic perspective. Data consisted of 20 semi-structured interviews with women previously diagnosed with GDM who had received the reminder. Interviews were analyzed using reflexive thematic analysis. RESULTS: The reminder affected women's decision-making and informed choices through a range of mechanisms. Its personalized design prompted feelings of co-responsibility and care from the healthcare system, supported continuity in women's care pathways, and helped women bridge the gap between healthcare sectors. Women's perception of diabetes risk and the importance of follow-up influenced their decision-making. Participation in follow-up screening was influenced by several contextual factors, as women's everyday life impeded their prioritizing follow-up screening. Women who experienced being met by their general practitioner (GP) with acknowledgement rather than stigmatization and received supportive information tailored to their life situation were more motivated to participate in future follow-up screenings. CONCLUSION: The reminder indicated both concern and co-responsibility for women's follow-up care after GDM and was well received by the women. It supported participation in follow-up screening through an emphasis on shared decision-making and informed choice. Women's interaction with their GP played a significant role.

The Patent Landscape for CRISPR Genome Editing in Australia.

Although Australia has a proud record of health and medical research, it finds less traction when it comes to innovative product development. Patent filings are recognised as one of the measures of national innovation, and this is one measure where Australian innovators are falling short. We examined whether there may be discrete pockets of innovation in particular areas of technology where Australian researchers are making significant contributions. This study used patent filings as a measure of innovation and used clustered regularly interspaced short palindromic repeat (CRISPR) genome editing as a case study. We found a rich patent landscape, with filings for general methods and compositions and for specific diseases. However, the contribution by Australian applicants was small, with only four out of 519 filings. This indicates that navigating the CRISPR patent landscape to secure freedom to operate is likely to be complex for Australian innovators in this field.

They Can Have Our Cake - But Can We Eat It? Access to Raw Genomic Data under Australian Privacy Law.

There is an increasing demand for the return of raw genomic data by research participants in translational genomic research. This article discusses the scope and application of privacy and freedom of information legislative provisions in Australia. Whether there is a right to access a copy of such data under Australian privacy legislation is contingent on whether raw genomic data can identify an individual and this article explores the opportunities for genomic data to be linked to individuals. We conclude that despite the complexity and overlapping nature of privacy laws in Australia, there is a clear right on the part of research participants to access their raw genomic data.

Women's experiences with managing advice on gestational diabetes - a qualitative interview study.

OBJECTIVE: This study aims to gain insight into women's experiences with gestational diabetes and their strategies to cope with advice for changing lifestyle. Further, health care professionals' approach to women with gestational diabetes is discussed. METHODS: Semi-structured interviews with nine women with gestational diabetes were conducted at a university hospital, adopting a phenomenological approach. RESULTS: Three themes were created: 1) Experience of control, 2) personal strategies, and 3) unintended consequences. Women experienced that the monitoring at the outpatient clinic was associated with surveillance and safety and adopted different strategies to cope with gestational diabetes. Some women experienced feeling different and labelled due to the monitoring and their eating habits. Some women expressed concern for the baby and the risk of getting diabetes after birth. Women's experiences and how they transfer and cope with information about gestational diabetes at an outpatient obstetric clinic are brought forward, and it became evident that individual needs in gestational diabetes care are not being met in all situations. CONCLUSION: Women experienced surveillance and safety while being monitored at the outpatient clinic. At the same time, self-monitoring seemed to stimulate feelings of concern about other's reactions to the condition. In addition, we found that women's strategies for behaviour change included limited food intake, controlling food purchases, and being physically active. Concerning the management of gestational diabetes, some women felt that the information was not sufficiently adapted to their individual needs, thus health professionals' approach to gestational diabetes should be based on the women's perspective.

An ethico-legal assessment of intellectual property rights and their effect on COVID-19 vaccine distribution: an Australian case study.

This article posits that Australia, as an affluent country with increasing capacity to manufacture vaccines, has an obligation to assist its regional (and global) counterparts in implementing vaccination programs that protect their populations. First, the article explores the capacity of high-income nations to meet their obligations, assist their neighbours and refrain from vaccine nationalism. This inquiry involves an analysis of the optimal ethical strategy for distributing vaccines globally, and the role that Australia might play in this distribution strategy. Secondly, the article examines the intellectual property landscape for vaccines in Australia, focusing on the patents that cover vaccine compositions and manufacturing techniques (recognizing the potential for know-how and access to materials as well as patents to affect manufacturing capacity). This article then discusses the strategies the Australian Government has at its disposal to counter potential intellectual property impediments whilst complying with existing obligations under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), as an ethically appropriate response to the pandemic. This article also considers whether a so-called TRIPS waiver could provide better options and concludes that the challenge of compelling disclosure of know-how remains.

Negligence and Health Innovation: Issues with the Standard of Care and the Need to Revisit the Voluntary Assumption of Risk.

This section examines current debates about the test for standards of care in negligence under the Civil Liability Acts in Australia, and how those debates may impact adversely on innovations in health care. It examines the recent history of attempts to define and regulate health innovation and compares them to judicial determinations from New South Wales that have potential to limit the protections otherwise afforded to competent professional practice. The section argues that, if those protections are eroded, alternative options to protect and encourage innovation should be explored, most especially a resuscitated defence of the voluntary assumption of risk.

Follow-up after gestational diabetes: a qualitative study of perspectives from general practices.

BACKGROUND: Women whose pregnancies are complicated by gestational diabetes mellitus (GDM) are approximately eight times more likely to develop type 2 diabetes mellitus (T2DM). Although regular participation in follow-up screening increases the chance of early detection of diabetes, participation rates are often suboptimal. A better understanding of general practice as a key contextual setting for screening could help inform the development and adoption of, for example, electronic reminder interventions to support women's participation. AIM: To explore the perspectives of GPs and relevant staff members engaged in early detection of diabetes after gestational diabetes in order to identify barriers to and facilitators of follow-up screening. DESIGN & SETTING: A qualitative interview study undertaken in general practices in the North Denmark Region. METHOD: Based on a purposive sample strategy, 18 semi-structured interviews of 12 GPs and six staff members, who were either nurses or midwives, were analysed using a reflexive thematic analytical approach. RESULTS: The following three main themes were formulated: (1) challenges of addressing women's risk; (2) prioritisation of early detection of diabetes; and (3) system influence on clinical procedures. CONCLUSION: Follow-up screening was facilitated by knowledge of guidelines. Professional collaboration and adaptation support were found to lead to successful implementation of guidelines in general practice. Supporting GPs and their staff's reflection and discussion of ways to engage in communication and decisionmaking processes with women is, however, important; it was found to create an important barrier to follow-up screening. Overall, the findings can help inform the future development of interventions to increase uptake.

Induced Pluripotent Stem Cell-Based Systems for Personalising Epilepsy Treatment: Research Ethics Challenges and New Insights for the Ethics of Personalised Medicine.

ABSTRACTThis paper examines potential ethical and legal issues arising during the research, development and clinical use of a proposed strategy in personalized medicine (PM): using human induced pluripotent stem cell (iPSC)-derived tissue cultures as predictive models of individual patients to inform treatment decisions. We focus on epilepsy treatment as a likely early application of this strategy, for which early-stage stage research is underway. In relation to the research process, we examine issues associated with biological samples; data; health; vulnerable populations; neural organoids; and what level of accuracy justifies using the iPSC-derived neural tissue system. In relation to clinical use, we examine potential uses in pre-natal screening, and effects on clinical decision-making. Although our focus is providing recommendations for researchers developing work in this area, we identify the novel issue of deciding on an acceptable accuracy level for the system. We also emphasize an issue thus far neglected in the ethics of PM: PM tends to represent treatment decisions as though they should be directed solely by biomedical information, but this in itself could be detrimental to best personalizing treatment decisions in the clinic.

Pain in Homebound Older Adults with Heart Failure after Hospital Discharge.

Pain is not uncommon in older adult patients with heart failure (HF) and has been identified as a risk factor for rehospitalization of homebound patients with HF. Little is known about the pain experiences and management of older adults with HF after hospital discharge. We sought to describe pain and other symptoms among homebound older adults with HF using a qualitative and descriptive approach. We conducted semistructured interviews to obtain qualitative data and used the Brief Pain Instrument-Short Form and the Edmonton Symptom Assessment Scale to obtain descriptive data on symptom burden. We interviewed 18 participants within 10 days after hospital discharge. Participants' mean age was 75.8 ± 9.0 years; 78% were White. The mean pain score at its worst was 5.2 ± 3.1, and for pain interfering with sleep was 4.3 ± 3.41. Most participants managed pain with medications. Using thematic analysis of qualitative data, we identified three distinct categories: (1) the diversity of patients' pain experiences, (2) the diversity of pain management routines, and (3) patients' experiences with healthcare providers' pain assessment and management practices. Our findings show that homebound older adults with HF experience various pain symptoms and receive inconsistent education about how to manage pain from healthcare providers. This study supports the need for better pain assessment and education about the appropriate use of pain medications and nonpharmacologic approaches to pain control for homebound older adults with HF.

How do reminder systems in follow-up screening for women with previous gestational diabetes work? - a realist review.

BACKGROUND: Women with previous gestational diabetes have an increased risk of developing type 2 diabetes later in life. Recommendations therefore urge these women to participate in follow-up screening, 4-12 weeks postpartum and every 1-3 years thereafter. We sought to theorize how reminder interventions to support early detection of diabetes work, for whom, and in what circumstances. METHODS: We used a method informed by realist review and synthesis. A systematic, iterative search in six electronic databases (PubMed, MEDLINE Ovid, The Cochrane Library, CINAHL, EMBASE) had a primary focus on experimental intervention studies and included additional information in relation to identified intervention studies. Analysis inductively identified context-mechanism-outcome configurations present in the evidence. RESULTS: We located 16 articles eligible for inclusion. A cross-case comparison identified seven grouped context-mechanism-outcome configurations leading to intervention mechanisms relating to changes in women's reasoning and behavior. Configurations were thematically ordered in relation to Systems Resources, Women's Circumstances, and Continuity of Care. These were mapped onto a socio-ecological model and discussed according to identified middle-range theories. CONCLUSION: Our findings adds to the body of evidence, that reminders have the potential to be effective in increasing participation in the recommended follow-up screening. Our study may assist researchers and policy and decision makers to analyze and judge if reminders are feasible and/or likely to succeed in their specific context. Further research into the perspective of socially disadvantaged and overweight women is needed to avoid unintended consequences such as social inequality in service use and stigmatization in future programs.

Evaluating implementation strategies for essential newborn care interventions in low- and low middle-income countries: a systematic review.

Neonatal mortality remains a significant health problem in low-income settings. Low-cost essential newborn care (ENC) interventions with proven efficacy and cost-effectiveness exist but have not reached high coverage (≥90%). Little is known about the strategies used to implement these interventions or how they relate to improved coverage. We conducted a systematic review of implementation strategies and implementation outcomes for ENC in low- and low middle-income countries capturing evidence from five medical and global health databases from 1990 to 2018. We included studies of implementation of delayed cord clamping, immediate drying, skin-to-skin contact (SSC) and/or early initiation of breastfeeding implemented in the first hour (facility-based studies) or the 1st day (community-based studies) of life. Implementation strategies and outcomes were categorized according to published frameworks: Expert Recommendations for Implementing Change and Outcomes for Implementation Research. The relationship between implementation strategies and outcomes was evaluated using standardized mean differences and correlation coefficients. Forty-three papers met inclusion criteria. Interventions included community-based care/health promotion and facility-based support and health care provider training. Included studies used 3-31 implementation strategies, though the consistency with which strategies were applied was variable. Conduct educational meetings was the most frequently used strategy. Included studies reported 1-4 implementation outcomes with coverage reported most frequently. Heterogeneity was high and no statistically significant association was found between the number of implementation strategies used and coverage of ENC. This review highlights several challenges in learning from implementation of ENC in low- and low middle-income countries, particularly poor description of interventions and implementation outcomes. We recommend use of UK Medical Research Council guidelines (2015) for process evaluations and checklists for reporting implementation studies. Improved reporting of implementation research in this setting is necessary to learn how to improve service delivery and outcomes and thereby reduce neonatal mortality.

Australian Perspectives on the Ethical and Regulatory Considerations for Responsible Data Sharing in Response to the COVID-19 Pandemic.

As the rush to understand and find solutions to the coronavirus disease 2019 pandemic continues, it is timely to re-examine the legal, social and ethical drivers for sharing health-related data from individuals around the globe. International collaboration and data sharing will be essential to the research effort. This raises the question of whether the urgent imperative to find therapies and vaccines may justify some temporary rebalancing of existing ethical and regulatory standards. The Global Alliance for Genomic Health is playing a leading role in collecting information about national approaches to these challenging questions. In this section, we examine some of the initiatives being taken in Australia against this global backdrop.

Healing architecture and Snoezelen in delivery room design: a qualitative study of women's birth experiences and patient-centeredness of care.

BACKGROUND: The physical place and environment has a profound influence on experiences, health and wellbeing of birthing women. An alternatively designed delivery room, inspired by the principles of healing architecture and Snoezelen, was established in a Danish regional hospital. These principles provided knowledge of how building and interior design affects the senses, including users' pain experience and stress levels. The aim of the study was to explore women's experience of the environment and its ability to support the concept of patient-centeredness in the care of birthing women. METHODS: Applying a hermeneutical-phenomenological methodology, fourteen semi-structured interviews with low-risk women giving birth in an alternative delivery room at an obstetric unit in Denmark were undertaken 3-7 weeks after birth. RESULTS: Overall, women's experiences of given birth in the alternative delivery room were positive. Our analysis suggests that the environment was well adapted to the women's needs, as it offered a stress- and anxiety-reducing transition to the hospital setting, at the same time as it helped them obtain physical comfort. The environment also signaled respect for the family's needs as it supported physical and emotional interaction between the woman and her partner and helped relieve her concern for the partner's well-being. The psychosocial support provided by the midwives appeared inseparable from the alternative delivery room, as both affected, amplified, and occasionally restricted the women's experience of the physical environment. CONCLUSION: Our findings support the use of principles of healing architecture and Snoezelen in birth environments and add to the evidence on how the physical design of hospital environments influence on both social and physical aspects of the well-being of patients. The environment appeared to encompass several dimensions of the concept of patient-centered care.

A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing.

Sharing of genomic and associated data is essential to clinical practice and biomedical research, and is increasingly encouraged by journals and funding bodies. Grappling with the range of legal and ethical issues raised by genomic data sharing presents a significant challenge, given the diversity of practices: from defined sharing of individual patient data, to broad-scale public sharing of research data, to uploading of direct-to-consumer test data by community members. Most commentary to date has discussed these issues in broad terms, but the debate can only progress if we engage with more granularity, grounded in jurisdictional and contextual specifics. We developed an empirical approach, creating a set of prototypical scenarios that capture the diversity of current genomic data sharing practices, which allows legal and ethical analysis of key issues at a granular level. The specificity of this approach provides a strong foundation for developing useful and relevant regulatory recommendations.

Don Chalmers: His Contributions to Legal Research and Education, Health Law, and Research Ethics, Locally and Globally.

Distinguished Professor Don Chalmers retired from the Law Faculty at the University of Tasmania on Friday 10 July 2020. This article is dedicated to Don, providing a brief account and acknowledgment of his fine contributions to legal research and education and law reform, particularly in the field of health and medical law, research ethics and policy reform. He has been an excellent colleague, mentor, leader, teacher, and researcher. He deserves to enjoy a long and rewarding retirement, though we, and many others, will not allow him to slip entirely out of the limelight. Don is still much needed, and still has so much to give in our ongoing quest to ensure that legal, research ethics and policy responses are adequate in reaping the benefits and responding to the challenges of biomedical advances.