Heritable Genome Editing in a Global Context: National and International Policy Challenges

A central problem for the international governance of heritable germline gene editing is that there are important differences in attitudes and values as well as ethical and health care considerations around the world. These differences are reflected in a complicated and diverse regulatory landscape. Several publications have discussed whether reproductive uses would be legally permissible in individual countries and whether clinical applications could emerge in the context of regulatory gaps and gray areas. Systematic comparative studies that explore issues related to the governance of this technology from different national and international perspectives are needed to address the lack of knowledge in this area. In this research report, we contribute to filling this gap by presenting views of stakeholders in the United Kingdom on challenges to the governance of heritable genome editing. We present findings from a multistakeholder study conducted in the United Kingdom between October 2016 and January 2018 and funded by the Wellcome Trust. This research included interviews, literature analysis, and a workshop. We involved leading U.K. scientists, in vitro fertilization clinicians, and representatives from regulatory bodies, patient organizations, and other civil societal organizations, as well as fertility companies. Part one of this article explores stakeholder perceptions of possible global developments in heritable genome editing and associated risks and governance challenges. Part two presents a range of policy options that were generated during the workshop in relation to the challenges discussed in part one.     

Implementation of the NICE guideline – Recommendations from the British Fertility Society for national criteria for NHS funding of assisted conception

It has been demonstrated that embryo transfer during IVF treatment can be performed competently and successfully by nurses (Barber et al., 1996). The present study has examined the success of nurses in training using the standardized protocol of this Unit. Initially, three nurses (two experienced (training completed) and one inexperienced (training ongoing)) each performed 80 transfers, which were standardized to three embryos replaced per transfer. The study aimed to establish whether a standardized procedure was undertaken by the nurses and to assess the influence of one inexperienced nurse performing the procedure. A further study (study 2) was performed to assess the influence of three inexperienced nurses against three experienced nurses undertaking the same procedures. In study 1, the pregnancy rates were 27.5%, 38.8% and 40.0% and there was no significant difference in the clinical pregnancy rates. In study 2, the pregnancy rates were 18.7%, 20.0% and 20.0% for the inexperienced nurses, and 26.3%, 30.0% and 32.5% for the experienced nurses. There was no significant difference in the clinical pregnancy rates within the inexperienced group or the experienced group. When the results of the three inexperienced nurses were grouped and were compared with those of the three experienced nurses, the pregnancy rates were 19.5% and 29.5%, respectively (P < 0.02). It has been shown that good clinical pregnancy rates can be achieved when nurses perform embryo transfer. There is no significant effect on clinical results when one nurse is in training; however, because of the expected learning curve, when three nurses train together a more significant effect is observed.     

Value of thyroid function tests in routine screening of women investigated for infertility

Women presenting with infertility traditionally have been screened for thyroid function, yet recent guidelines have indicated that this is unnecessary in asymptomatic patients. A retrospective analysis of the results of routine thyroid function screening showed that occult thyroid dysfunction is common: 5.1% of the population studied had abnormal thyroid function tests. Therefore, it is recommended that assessment of thyroid function in women attending an infertility clinic should be continued.     

Hip fracture in elderly patients: outcomes for function, quality of life, and type of residence

A prospective study was done to investigate functional outcome, quality of life, and type of residence after hip fracture in patients 65 years of age and older. One hundred two patients admitted consecutively to a university and a general hospital were followed up as long as 4 months after admission. The mean age of the participants was 83 years; 58% of patients came from their own home, and 42 % of patients came from institutions. Nearly 70% of patients had two or more diagnoses other than the hip fracture. Cumulative mortality was 20% at 4 months after fracture. Of surviving patients, 57% were back in their original situation for accommodation, 43% reached the same level of walking ability, and 17% achieved the same level of activities of daily living as before fracture. Patients experienced on average three complications, 26% of which were severe. Quality of life improved in the followup period of 4 months; however, the quality of life at 4 months was worse than the quality of life reported in a reference population. Average costs amounted to euro (Euro) 15.338 (which at the time was nearly equivalent to the US dollar) per patient, with nearly 50% of the costs attributable to hospital costs and 30% attributable to nursing home costs. The results of this study show a poor outcome after hip fracture in elderly patients.     

Tympanometry interpretation by primary care physicians. A report from the International Primary Care Network (IPCN) and the Ambulatory Sentinel Practice Network (ASPN)

BACKGROUND: The accuracy of data gathered by primary care clinicians in practice-based research networks (PBRNs) has been questioned. Tympanometry, recently recommended as a means of improving accuracy of diagnosing acute otitis media, was included as an objective diagnostic measure in an international PBRN study. We report the level of agreement of interpretations of tympanograms between primary care physicians in PBRNs and experts. METHODS: Primary care physicians in PBRNs in the Netherlands, United Kingdom, United States, and Canada enrolled 1773 children aged 6 to 180 months who contributed 6358 tympanograms during 3179 visits. The physicians were trained in the use and interpretation of tympanometry using the Modified Jerger Classification. We determined the level of agreement between physicians and experts for interpretation of tympanograms. One comparison used the 6358 individual ear tracings. A second comparison used the 3179 office visits by children as the unit of analysis. RESULTS: The distribution of expert interpretation of all tympanograms was: 35.8% A, 30% B, 15.5% C1, 12% C2, and 6.8% uninterpretable; for visits, 37.8% were normal (A or C1), 55.6% abnormal (B or C2), and 6.6% could not be classified. There was a high degree of agreement in the interpretation of tympanograms between experts and primary care physicians across networks (kappa=0.70-0.77), age groups of children (kappa=0.69-0.73), and types of visits (kappa=0.66-0.77). This high degree of agreement was also found when children were used as a unit of analysis. CONCLUSIONS: Interpretations of tympanograms by primary care physicians using the Modified Jerger Classification can be used with confidence. These results provide further evidence that practicing primary care physicians can provide high-quality data for research purposes.