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).

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.

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.

Provenance and risk in transfer of biological materials.

Whereas biological materials were once transferred freely, there has been a marked shift in the formalisation of exchanges involving these materials, primarily through the use of Material Transfer Agreements (MTAs). This paper considers how risk aversion dominates MTA negotiations and the impact it may have on scientific progress. Risk aversion is often based on unwarranted fears of incurring liability through the use of a material or loss of control or missing out on commercialisation opportunities. Evidence to date has suggested that complexity tends to permeate even straightforward transactions despite extensive efforts to implement simple, standard MTAs. We argue that in most cases, MTAs need do little more than establish provenance, and any attempt to extend MTAs beyond this simple function constitutes stifling behaviour. Drawing on available examples of favourable practice, we point to a number of strategies that may usefully be employed to reduce risk-averse tendencies, including the promotion of simplicity, education of those engaged in the MTA process, and achieving a cultural shift in the way in which technology transfer office (TTO) success is measured in institutions employing MTAs.

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.

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.

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.

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.

Terms of Engagement: Transfer of Biological Materials for Research in Australia.

The shift from basic science to potentially more lucrative applied science and commercialisation has had a profound impact on sharing biological materials for research purposes. Free exchanges of ideas and research materials have become cloaked in contractual obligations, driven by commercialisation and impact policies, particularly through material transfer agreements (MTAs). There has been no analysis of the terms included in MTAs routinely used by Australian universities and research institutes for the transfer of biological materials for research. This study analyses terms from 45 MTAs used by Australian universities and research organisations as well as common standard agreements. Our findings suggest that drafters need to refocus MTA terms to the purpose behind which materials are exchanged. Terms need to be directed primarily towards compatibility with the research effort rather than the remote possibility of future commercial and translational opportunities. This refocusing should simplify MTA terms, expediting materials transfer and supporting research.

Correction to: Australia: regulating genomic data sharing to promote public trust.

This article was inadvertently published under a draft title.

Australia: regulating genomic data sharing to promote public trust.

The regulation of genomic data sharing in Australia is a confusing mix of common law, legislation, ethical guidelines, and codes of practice. Beyond privacy laws, which only apply to genomic data that meets the definition of personal information, the key regulatory lever is the National Health and Medical Research Council (NHMRC) National Statement for Ethical Conduct in Human Research ("National Statement") (2007). Compliance with the National Statement is a requirement for institutions to apply to the NHMRC for funding, and includes-among other things-requirements for review of most genomic research by Human Research Ethics Committees. The sections of the National Statement specifying requirements for research with human genomic data are currently under review, including proposed new requirements addressing the return of genetic research findings and oversight of transfer agreements. Ensuring the willingness of Australians to donate their genomic information and participate in medical research will require clarification and harmonisation of the applicable regulatory framework, along with reforms to ensure that these regulations reflect the conditions necessary to promote ongoing public trust in researchers and institutions.

Lower versus higher hemoglobin threshold for transfusion in septic shock.

BACKGROUND: Blood transfusions are frequently given to patients with septic shock. However, the benefits and harms of different hemoglobin thresholds for transfusion have not been established. METHODS: In this multicenter, parallel-group trial, we randomly assigned patients in the intensive care unit (ICU) who had septic shock and a hemoglobin concentration of 9 g per deciliter or less to receive 1 unit of leukoreduced red cells when the hemoglobin level was 7 g per deciliter or less (lower threshold) or when the level was 9 g per deciliter or less (higher threshold) during the ICU stay. The primary outcome measure was death by 90 days after randomization. RESULTS: We analyzed data from 998 of 1005 patients (99.3%) who underwent randomization. The two intervention groups had similar baseline characteristics. In the ICU, the lower-threshold group received a median of 1 unit of blood (interquartile range, 0 to 3) and the higher-threshold group received a median of 4 units (interquartile range, 2 to 7). At 90 days after randomization, 216 of 502 patients (43.0%) assigned to the lower-threshold group, as compared with 223 of 496 (45.0%) assigned to the higher-threshold group, had died (relative risk, 0.94; 95% confidence interval, 0.78 to 1.09; P=0.44). The results were similar in analyses adjusted for risk factors at baseline and in analyses of the per-protocol populations. The numbers of patients who had ischemic events, who had severe adverse reactions, and who required life support were similar in the two intervention groups. CONCLUSIONS: Among patients with septic shock, mortality at 90 days and rates of ischemic events and use of life support were similar among those assigned to blood transfusion at a higher hemoglobin threshold and those assigned to blood transfusion at a lower threshold; the latter group received fewer transfusions. (Funded by the Danish Strategic Research Council and others; TRISS ClinicalTrials.gov number, NCT01485315.).

Novel micro-reactor flow cell for investigation of model catalysts using in situ grazing-incidence X-ray scattering.

The design, fabrication and performance of a novel and highly sensitive micro-reactor device for performing in situ grazing-incidence X-ray scattering experiments of model catalyst systems is presented. The design of the reaction chamber, etched in silicon on insulator (SIO), permits grazing-incidence small-angle X-ray scattering (GISAXS) in transmission through 10 µm-thick entrance and exit windows by using micro-focused beams. An additional thinning of the Pyrex glass reactor lid allows simultaneous acquisition of the grazing-incidence wide-angle X-ray scattering (GIWAXS). In situ experiments at synchrotron facilities are performed utilizing the micro-reactor and a designed transportable gas feed and analysis system. The feasibility of simultaneous in situ GISAXS/GIWAXS experiments in the novel micro-reactor flow cell was confirmed with CO oxidation over mass-selected Ru nanoparticles.

Low prevalence of oral and nasal human papillomavirus in employees performing CO2-laser evaporation of genital warts or loop electrode excision procedure of cervical dysplasia.

Risk of human papillomavirus (HPV) transmission during laser vaporisation of genital warts or loop electrode excision procedure is controversial. An oral rinse, a nasal swabs, history of HPV related diseases and data on HPV exposure were collected from 287 employees at departments of dermato-venerology and gynaecology in Denmark. A mucosal HPV type was found among 5.8% of employees with experience of laser treatment of genital warts as compared to 1.7% of those with no experience (p = 0.12). HPV prevalence was not higher in employees participating in electrosurgical treatment or cryotherapy of genital warts, or loop electrode excision procedure compared with those who did not. HPV 6 or 11 were not detected in any samples. Hand warts after the age of 24 years was more common among dermatology than among non-dermatology personnel (18% vs. 8.0%, p = 0.03). Mucosal HPV types are infrequent in the oral and nasal cavity of health care personnel, however, employees at departments of dermato-venereology are at risk of acquiring hand warts.

Associations between follow-up screening after gestational diabetes and early detection of diabetes--a register based study.

BACKGROUND: Women whose pregnancy was complicated by gestational diabetes have a 7-fold higher risk of developing diabetes, primarily type 2. Early detection can prevent or delay the onset of late complications, for which follow-up screening is important. This study investigated the extent of participation in follow-up screening and the possible consequences of nonattendance in the Region of North Jutland, Denmark. METHOD: In Danish national registers covering the years 1994-2011 we identified 2171 birthing women whose pregnancy was complicated by first-time gestational diabetes. Control visits to general practitioners and biochemical departments after giving birth were charted. Following national guidelines we defined four intervals for assessment of participation in follow-up screening. Diagnosis of diabetes or treatment with glucose-lowering agents after giving birth were also identified. Participation in follow-up screening and risk of diabetes was calculated. Time to obtaining diagnosis of diabetes or initiating treatment was analysed by Cox regression models. All models were adjusted for age, ethnicity and income. RESULTS: High attendance was found during the first control interval, after which attendance decreased with time after giving birth for both controls at general practitioners and biochemical departments. All differences in proportions were statistically significant. Women attending controls at general practitioners had a significantly higher risk of diabetes diagnosis and treatment after gestational diabetes than women not attending. The results for women attending testing at biochemical departments also showed an increased risk of initiation of treatment. Women attending at least one general practitioners control had a significantly higher risk of early diabetes diagnosis or treatment. Time to initiation of treatment was significantly higher for testing at biochemical departments. Women with high incomes had a significantly lower risk of diabetes diagnosis or initiation of treatment compared to low-income women. CONCLUSION: Participation in follow-up screening after gestational diabetes is low in the North Denmark Region. Follow-up screening ensures early detection of diabetes and initiation of treatment. Our results emphasize the importance of development of interventions to improve early detection and prevention of diabetes after gestational diabetes.

Data access arrangements in genomic research consortia.

One of the most common terms that is used to describe entities responsible for sharing genomic data for research purposes is 'genomic research consortium'. However, there is a lack of clarity around the language used by consortia to describe their data sharing arrangements. Calls have been made for more uniform terminology. This article reports on a review of the genomic research consortium literature illustrating a wide diversity in the language that has been used over time to describe the access arrangements of these entities. The second component of this research involved an examination of publicly available information from a dataset of 98 consortia. This analysis further illustrates the wide diversity in the access arrangements adopted by genomic research consortia. A total of 12 different access arrangements were identified, including four simple forms (open, consortium, managed and registered access) and eight more complex tiered forms (for example, a combination of consortium, managed and open access). The majority of consortia utilised some form of tiered access, often following the policy requirements of funders like the US National Institutes of Health and the UK Wellcome Trust. It was not always easy to precisely identify the access arrangements of individual consortia. Greater consistency, clarity and transparency is likely to be of benefit to donors, depositors and accessors alike. More work needs to be done to achieve this end.

Development and early implementation of telemonitoring of complicated pregnancies - A qualitative study with the perspectives of health professionals.

BACKGROUND: Telemonitoring may offer promising opportunities in health care. In obstetric health care, there is a need to expand and improve digitalization. Nevertheless, there is limited knowledge based on healthcare professionals' perspectives regarding the use of telemedicine and remote cardiotocography during pregnancy, as well as its implementation. AIM: To explore the perspectives of health-care professionals who manage telemonitoring of complicated pregnancies. DESIGN AND SETTING: A qualitative interview study undertaken in a hospital with a tertiary obstetric unit in Northen Denmark. METHODS: Based on a purposive sample strategy, 11 semi-structured interviews of health-care professionals involved in the management of telemonitoring in women with complicated pregnancies were conducted and analyzed using a reflexive thematic analytical approach. FINDINGS: The findings are assembled into two main themes. The experience of relevance to own practice: included the embedded potentials in telemonitoring providing women-centred care, but also challenges related to the implementation of a new technology. Experience of challenges and potential in day-to-day operation: included frustrations regarding the technological devices and software, working experiences increasing confidence in telemonitoring, and perspectives on the required interdependence across departments. CONCLUSION: This study adds important knowledge to support awareness and reflection on how challenges impact the successful implementation of telemonitoring in obstetric and midwifery care. This includes knowledge of important processes and resources to ensure ongoing implementation and evaluation. Implementation strategies and collaborations to support a multiple-level system change, such as an interdisciplinary team, seem crucial to minimize challenges, build shared visions, and engage staff.