Assisted human reproduction legislation: Listening to the voice of patients.

OBJECTIVE: Legislation and policies regarding assisted human reproduction (AHR) vary widely across nations and societies. As one of only 5 European countries which currently lacks legislation, Ireland now has a unique opportunity to learn from other jurisdictions and introduce AHR law that is reflective of the ongoing myriad developments in this complex field. Draft legislation, initially published in 2017, was revised in 2022 with strong political commitment to enacting in the same year. This study sought to ascertain the views of fertility patients (service users) to the proposed AHR legislation in its current format, prior to its implementation. STUDY DESIGN: A survey questionnaire, previously designed to investigate the attitudes and perceptions of healthcare professionals (HCPs) towards a broad range of issues contained within the draft AHR Bill, was adapted for a patient/service user population. The survey link was distributed via secure email to all patients that had a doctor consult at our fertility clinic in 2020-2021. RESULTS: The survey link was sent to 4420 patients/service users, of whom 1044 (23.6%) responded. A majority had experienced AHR treatment. Service users indicated strong support for AHR regulation and for access to all AHR techniques for all patients, irrespective of relationship or gender status. A majority of respondents disagreed with aspects of the draft bill regarding mandatory counselling, the timing of assignment of parentage in surrogacy, the exclusion of international surrogacy and the exclusion of men from posthumous AHR. Interestingly, the fertility patient cohort were more liberal in their views and opinions regarding AHR than the Irish HCPs previously surveyed. CONCLUSION: This study demonstrates the views of a large group of AHR patients/service users towards proposed AHR legislation. Many of their views concur with but others differ from those of the drafters of the legislation and from those of healthcare professionals. Consideration of the views of all these groups and a collaborative approach would help ensure that Ireland has AHR legislation that is inclusive and fit for purpose in the 21st century.

International consensus on the non-pharmacological and non-surgical management of osteoporotic vertebral fractures.

We identified a knowledge gap in the non-pharmacological and non-surgical management of osteoporotic vertebral fractures. MAIN RESULTS: This international consensus process established multidisciplinary biopsychosocial recommendations on pain, nutrition, safe movement, and exercise for individuals with acute and chronic vertebral fractures. SIGNIFICANCE: These recommendations will guide clinical practice and inform interventions for future research. PURPOSE: To establish international consensus on recommendations for the non-pharmacological and non-surgical management of osteoporotic vertebral fractures. METHODS: We adopted a five-step modified Delphi consensus process: (1) literature search and content analysis, (2) creation of the survey, (3) selection of the expert panel, (4) first round of the rating process, and (5) second round of the rating process. The first round included 49 statements and eight open-ended questions; the second round included 30 statements. Panelists were asked to rate their agreement with each of the statements using a 9-point scale, with the option to provide further comments. Consensus for each statement was determined by counting the number of panelists whose rating was outside the 3-point region containing the median. RESULTS: We invited 76 people with degree in medicine, physiotherapy, kinesiology, and experience in the management of osteoporotic vertebral; 31 (41%) and 27 (36%) experts agreed to participate to the first and the second round, respectively. The mean percentage agreement after the first and second rounds was 76.6% ± 16.0% and 90.7% ± 6.5%, respectively. We established consensus on recommendations on pain, early satiety, weight loss, bracing, safe movement, and exercise for individuals with acute and chronic vertebral fractures. CONCLUSION: Our international consensus provides multidisciplinary biopsychosocial recommendations to guide the management of osteoporotic vertebral fractures and inform interventions for future research.

Removing the men who have sex with men blood donation deferral: Informing risk models using Canadian public health surveillance data.

OBJECTIVE: Gay, bisexual and other men who have sex with men (gbMSM) were ineligible to donate blood in most countries since the 1980's. In Canada the deferral period has been incrementally decreased from lifetime to male-to-male sex in the last 3 months. Now a few countries have removed the deferral altogether. Risk models have been utilised to estimate the probability of an HIV positive donation being released into the blood supply and to inform incremental changes to the length of the deferral period. Here we use public health data to estimate the risk of HIV if the gbMSM deferral criteria were removed in Canada. MATERIAL AND METHODS: We calculate the risk reduction among heterosexuals based on responses to standard risk questions routinely asked of donors. We assume gbMSM will donate at the same rate as heterosexual males. We apply the same risk reduction principle to HIV incidence and prevalence among gbMSM in the general population to evaluate the HIV risk without gbMSM time deferral. We model three scenarios where risk reduction is varied by assumptions about incidence and compliance with deferral criteria. RESULTS: The estimates for all scenarios were not significantly different to the currently observed scenario which predicts a residual risk of 0.02 HIV positive per million donations (95% CI: 0.000006-0.09). CONCLUSION: The models predict that removing the gbMSM deferral criteria would result in HIV residual risk similar to currently observed.

Is high hemoglobin a hindrance factor for blood donation? A pilot observational study from the coastal region of India.

BACKGROUND: Blood donors with high Hb are often deferred for the presumed risk of polycythemia vera (PV). However, adequate data to substantiate or refute this hypothesis is lacking. METHODOLOGY: We conducted an observational study on blood donors found to have high hemoglobin (Hb≥18g/dL) during the pre-donation screening process using a portable hemoglobinometer at our blood center for four months. We adopted a cost effective methodology wherein a questionnaire was used to elicit the secondary causative factors of high hemoglobin and a complete blood count test to observe the blood cell parameters and JAK2V617F mutation test was performed in a subset of donors lacking secondary erythrocytosis (SE) history. RESULTS: Of the total 7076 donors enrolled, 112 male donors (1.58%) had high hemoglobin. The majority (70.4%) were repeat donors with mean age of 31.4 years. About 61% of the donors had attributable factors for SE like smoking, occupational exposure to carbon monoxide. The mean hemoglobin value of capillary and venous hemoglobin demonstrated a statistically significant difference (P<0.05) where 2.7% of donors had venous Hb<18g/dL. The hematological profile of all the donors showed increased RBC but normal platelet and WBC count. Of 24 donors included for the JAK2V617F test, none had a positive report. CONCLUSION: This study suggests high hemoglobin in blood donors is less likely due to PV. Hence, re-considering their deferral may help alleviate donor anxiety and allow donor return. However, multi-centric studies are required to develop consensus statements on PV risk status and blood donation eligibility.

In Our Own Words: The Complex Sensory Experiences of Autistic Adults.

Autistic adults commonly experience sensory reactivity differences. Sensory hyperreactivity is frequently researched, whilst hyporeactivity and seeking, and experiences across domains, e.g., vision, are often neglected. Therefore, we aimed to understand more about the sensory experiences of autistic adults. We conducted a mixed-methods study, co-produced with stakeholders; recruiting 49 autistic adults who completed an online survey. Firstly, quantitative results and content analysis enhanced our understanding of sensory input/contexts associated with sensory hyperreactivity, hyporeactivity, and seeking across modalities. Secondly, thematic analysis developed themes relating to 'Outcomes', 'Control', 'Tolerance and management', and 'The role of other people', informing a theoretical model of sensory reactivity differences in autistic adults. These findings have implications for support services and improving quality of life for autistic adults.

School-based surveillance of acute infectious disease in children: a systematic review.

BACKGROUND: Syndromic surveillance systems are an essential component of public health surveillance and can provide timely detection of infectious disease cases and outbreaks. Whilst surveillance systems are generally embedded within healthcare, there is increasing interest in novel data sources for monitoring trends in illness, such as over-the-counter purchases, internet-based health searches and worker absenteeism. This systematic review considers the utility of school attendance registers in the surveillance of infectious disease outbreaks and occurrences amongst children. METHODS: We searched eight databases using key words related to school absence, infectious disease and syndromic surveillance. Studies were limited to those published after 1st January 1995. Studies based in nursery schools or higher education settings were excluded. Article screening was undertaken by two independent reviewers using agreed eligibility criteria. Data extraction was performed using a standardised data extraction form. Outcomes included estimates of absenteeism, correlation with existing surveillance systems and associated lead or lag times. RESULTS: Fifteen studies met the inclusion criteria, all of which were concerned with the surveillance of influenza. The specificity of absence data varied between all-cause absence, illness absence and syndrome-specific absence. Systems differed in terms of the frequency of data submissions from schools and the level of aggregation of the data. Baseline rates of illness absence varied between 2.3-3.7%, with peak absences ranging between 4.1-9.8%. Syndrome-specific absenteeism had the strongest correlation with other surveillance systems (r = 0.92), with illness absenteeism generating mixed results and all-cause absenteeism performing the least well. A similar pattern of results emerged in terms of lead and lag times, with influenza-like illness (ILI)-specific absence providing a 1-2 week lead time, compared to lag times reported for all-cause absence data and inconsistent results for illness absence data. CONCLUSION: Syndrome-specific school absences have potential utility in the syndromic surveillance of influenza, demonstrating good correlation with healthcare surveillance data and a lead time of 1-2 weeks ahead of existing surveillance measures. Further research should consider the utility of school attendance registers for conditions other than influenza, to broaden our understanding of the potential application of this data for infectious disease surveillance in children. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2019 CRD42019119737.

An update on acalabrutinib to treat chronic lymphocytic leukemia.

Acalabrutinib was approved by the U.S. Food and Drug Administration (FDA) for treatment-naive (TN) and relapsed/refractory (R/R) use for patients with chronic lymphocytic leukemia (CLL) in November 2019 following the phase III ASCEND and ELEVATE-TN registration trials. Acalabrutinib is a second-generation Bruton tyrosine kinase inhibitor (BTKi) that was developed after ibrutinib, the first-in-class BTKi. Ibrutinib is usually well tolerated and provides durable remissions; however, some patients experience toxicities from the off-target effects that lead to treatment discontinuation. A recent press release of the phase III ELEVATE-RR trial comparing acalabrutinib to ibrutinib in relapsed high-risk CLL reported noninferior progression-free survival and statistically significantly lower rates of atrial fibrillation; however, publication of this data is pending. There is currently 53 months of follow-up for patients receiving acalabrutinib compared with 8 years for those on ibrutinib. Acalabrutinib is approved as monotherapy in the R/R or TN setting, and in the TN setting can be combined with the anti-CD20 monoclonal antibody obinutuzumab. The data for acalabrutinib development and clinical use are discussed in this review.

Changes in Multidisciplinary Tracheostomy Team Practice Over Time.

Aim Increasing numbers of tracheostomy patients are discharged from the Intensive Care Unit (ICU) to general hospital wards. There is evidence that a Multidisciplinary Tracheostomy Team (MTT) can have a positive impact on the care of tracheostomy patients discharged from the ICU. We compared tracheostomy management and patient outcome in two time periods, at the start of our MTT practice in 2009-2011 and again in 2017. Methods In a retrospective audit, we compared tracheostomy management and patient outcome in 117 patients who had a tracheostomy in 2009-2011 with 81 patients who had a tracheostomy in 2017. Results The duration of tracheostomy cannulation was significantly shorter (21 vs 31 days, p=0.0005) in 2017 compared to 2009-2011. A Mini-Trach was used after tracheostomy decannulation in 56 of the 81 (69%) tracheostomy patients in 2017. Conclusions The continued development of our MTT service over 8 years was associated with a significantly shorter duration of tracheostomy cannulation and the introduction of Mini-Trach use after tracheostomy decannulation. These results support the importance of maintaining an active MTT service to manage tracheostomy patients after discharge from the ICU.

Evaluating the impact of a pharmacist-led prescribing feedback intervention on prescribing errors in a hospital setting.

BACKGROUND: Prescribing errors are prevalent in hospital settings with provision of feedback recommended to support prescribing of doctors. Feedback on prescribing has been described as feasible and valued but limited by doctors, with pharmacists described as credible facilitators of prescribing feedback. Evidence supporting prescribing feedback has been limited to date. A formalised programme of pharmacist-led prescribing error feedback was designed and implemented to support prescribers. OBJECTIVE: To evaluate the impact of a prescribing feedback intervention on prescribing error rates and frequency of prescribing error severity and type. METHOD: Prospective prescribing audits were undertaken across sixteen hospital wards in a UK teaching hospital over a five day period with 36 prescribers in the intervention group and 41 in the control group. The intervention group received pharmacist-led, individualised constructive feedback on their prescribing, whilst the control group continued with existing practice. Prescribing was re-audited after three months. Prescribing errors were classified by type and severity and data were analysed using relevant statistical tests. RESULTS: A total of 5191 prescribed medications were audited at baseline and 5122 post-intervention. There was a mean prescribing error rate of 25.0% (SD 16.8, 95% CI 19.3 to 30.7) at baseline and 6.7% (SD 9.0, 95% CI 3.7 to 9.8) post-intervention for the intervention group, and 19.7% (SD 14.5, 95% CI 15.2 to 24.3) at baseline and 25.1% (SD 17.0, 95% CI 19.8 to 30.6) post-intervention for the control group with a significant overall change in prescribing error rates between groups of 23.7% (SD 3.5, 95% CI, -30.6 to -16.8), t(75) = -6.9, p < 0.05. The frequency of each error type and severity rating was reduced in the intervention group, whilst the error frequency of some error types and severity increased in the control group. CONCLUSION: Pharmacist-led prescribing feedback has the potential to reduce prescribing errors and improve prescribing outcomes and patient safety.

Intramuscular oxytocin versus Syntometrine® versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: a randomised double-blinded clinical trial of effectiveness, side effects and quality of life.

OBJECTIVE: To compare intramuscular oxytocin, Syntometrine® and carbetocin for prevention of postpartum haemorrhage after vaginal birth. DESIGN: Randomised double-blinded clinical trial. SETTING: Six hospitals in England. POPULATION: A total of 5929 normotensive women having a singleton vaginal birth. METHODS: Randomisation when birth was imminent. MAIN OUTCOME MEASURES: Primary: use of additional uterotonic agents. Secondary: weighed blood loss, transfusion, manual removal of placenta, adverse effects, quality of life. RESULTS: Participants receiving additional uterotonics: 368 (19.5%) oxytocin, 298 (15.6%) Syntometrine and 364 (19.1%) carbetocin. When pairwise comparisons were made: women receiving carbetocin were significantly more likely to receive additional uterotonics than those receiving Syntometrine (odds ratio [OR] 1.28, 95% CI 1.08-1.51, P = 0.004); the difference between carbetocin and oxytocin was non-significant (P = 0.78); Participants receiving Syntometrine were significantly less likely to receive additional uterotonics than those receiving oxytocin (OR 0.75, 95% CI 0.65-0.91, P = 0.002). Non-inferiority between carbetocin and Syntometrine was not shown. Use of Syntometrine reduced non-drug PPH treatments compared with oxytocin (OR 0.64, 95% CI 0.42-0.97) but not carbetocin (P = 0.64). Rates of PPH and blood transfusion were not different. Syntometrine was associated with an increase in maternal adverse effects and reduced ability of the mother to bond with her baby. CONCLUSIONS: Non-inferiority of carbetocin to Syntometrine was not shown. Carbetocin is not significantly different to oxytocin for use of additional uterotonics. Use of Syntometrine reduced use of additional uterotonics and need for non-drug PPH treatments compared with oxytocin. Increased maternal adverse effects are a disadvantage of Syntometrine. TWEETABLE ABSTRACT: IM carbetocin does not reduce additional uterotonic use compared with IM Syntometrine or oxytocin.

Risk factors associated with outbreaks of seasonal infectious disease in school settings, England, UK.

Children are important transmitters of infection. Within schools they encounter large numbers of contacts and infections can spread easily causing outbreaks. However, not all schools are affected equally. We conducted a retrospective analysis of school outbreaks to identify factors associated with the risk of gastroenteritis, influenza, rash or other outbreaks. Data on reported school outbreaks in England were obtained from Public Health England and linked with data from the Department for Education and the Office for Standards in Education, Children's Services and Skills (Ofsted). Primary and all-through schools were found to be at increased risk of outbreaks, compared with secondary schools (odds ratio (OR) 5.82, 95% confidence interval (CI) 4.50-7.58 and OR 4.66, 95% CI 3.27-6.61, respectively). School size was also significantly associated with the risk of outbreaks, with higher odds associated with larger schools. Attack rates were higher in gastroenteritis and influenza outbreaks, with lower attack rates associated with rashes (relative risk 0.17, 95% CI 0.15-0.20). Deprivation and Ofsted rating were not associated with either outbreak occurrence or the subsequent attack rate. This study identifies primary and all-through schools as key settings for health protection interventions. Public health teams need to work closely with these schools to encourage early identification and reporting of outbreaks.

Spanish Adaptation of the Inventory of Depression and Anxiety Symptoms (IDAS-II) and a study of its psychometric properties.

BACKGROUND: The Inventory of Depression and Anxiety Symptoms (IDAS-II) is composed of 99 items organized into 18 specific scales that provides dimensional assessment of depression, anxiety and bipolar symptoms. To date, IDAS-II is only available in the English and Turkish population. The main purpose of this study is to adapt the IDAS-II to the Spanish population and to assess the psychometric properties. METHODS: Participants included community adults (n = 620) and college students (n = 378). All participants completed the Beck Depression Inventory-II, Beck Anxiety Inventory, Hypomania Check List-32, Post-traumatic Stress Disorder Checklist-Civilian Version and Obsessive-Compulsive Inventory-Revised, in addition to the Spanish version of the IDAS-II. RESULTS: The results indicate good internal consistency and high temporal stability of the Spanish version of the IDAS-II. Confirmatory factor analyses show for the first time that the three-factor structure of the IDAS-II (Distress, Obsessions/Fear, and Positive Mood) loads on a second order factor, labeled "Internalizing" according to the Hierarchical Taxonomy Of Psychopathology (HiTOP). LIMITATIONS: Study was conducted exclusively on student and community samples and some of the measures used as gold-standard have presented limitations CONCLUSIONS: According to previous studies, the results supported the convergent and discriminant validity of the majority of IDAS-II scales. IDAS-II is useful in assessing the severity of depression, anxiety and bipolar symptoms in research contexts in a Spanish population according to the HiTOP model. However, more evidence is required to prove the adequate functioning of the IDAS-II in clinical samples.

Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.

OBJECTIVE: To compare electrodiathermy with helium thermal coagulation in laparoscopic treatment of mild-to-moderate endometriosis. DESIGN: Parallel-group randomised controlled trial. SETTING: A UK endometriosis centre. POPULATION: Non-pregnant women aged 16-50 years with a clinical diagnosis of mild-to-moderate endometriosis. METHODS: If mild or moderate endometriosis was confirmed at laparoscopy, women were randomised to laparoscopic treatment with electrodiathermy or helium thermal coagulator. MAIN OUTCOME MEASURES: Cyclical pain and dyspareunia (rated on a 100-mm visual analogue scale, VAS), quality of life at baseline and at 6, 12 and 36 weeks following surgery, operative blood loss and surgical complications. RESULTS: A total of 192 women were randomised. Of these, 155 (81%) completed the primary outcome point at 12 weeks. In an intention-to-treat analysis, VAS scores for cyclical pain were significantly lower in the electrodiathermy group compared with the helium group at 12 weeks (mean difference, 9.43 mm; 95% CI 0.46, 18.40 mm; P = 0.039) and across all time points (mean difference, 10.13 mm; 95% CI 3.48, 16.78 mm; P = 0.003). A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference, 11.66 mm; 95% CI 1.39, 21.93 mm; P = 0.026). These effects were smaller than the proposed minimum important difference of 18.00 mm, however. Differences in some aspects of quality of life favoured electrodiathermy. There was no significant difference in operative blood loss (fold-change with helium as reference, 1.43; 95% CI 0.96, 2.15; P = 0.081). CONCLUSIONS: Although electrodiathermy was statistically superior to helium ablation in reducing cyclical pain and dyspareunia, these effects may be too small to be clinically significant. TWEETABLE ABSTRACT: Helium coagulation is not superior to electrodiathermy in laparoscopic treatment of mild-to-moderate endometriosis.

Regional differences in presence of Shiga toxin-producing Escherichia coli virulence-associated genes in the environment in the North West and East Anglian regions of England.

Shiga toxin-producing Escherichia coli is carried in the intestine of ruminant animals, and outbreaks have occurred after contact with ruminant animals or their environment. The presence of STEC virulence genes in the environment was investigated along recreational walking paths in the North West and East Anglia regions of England. In all, 720 boot sock samples from walkers' shoes were collected between April 2013 and July 2014. Multiplex PCR was used to detect E. coli based on the amplification of the uidA gene and investigate STEC-associated virulence genes eaeA, stx1 and stx2. The eaeA virulence gene was detected in 45·5% of the samples, where stx1 and/or stx2 was detected in 12·4% of samples. There was a difference between the two regions sampled, with the North West exhibiting a higher proportion of positive boot socks for stx compared to East Anglia. In univariate analysis, ground conditions, river flow and temperature were associated with positive boot socks. The detection of stx genes in the soil samples suggests that STEC is present in the English countryside and individuals may be at risk for infection after outdoor activities even if there is no direct contact with animals. SIGNIFICANCE AND IMPACT OF THE STUDY: Several outbreaks within the UK have highlighted the danger of contracting Shiga toxin-producing Escherichia coli from contact with areas recently vacated by livestock. This is more likely to occur for STEC infections compared to other zoonotic bacteria given the low infectious dose required. While studies have determined the prevalence of STEC within farms and petting zoos, determining the risk to individuals enjoying recreational outdoor activities that occur near where livestock may be present is less researched. This study describes the prevalence with which stx genes, indicative of STEC bacteria, were found in the environment in the English countryside.

Investigation of a foodborne outbreak of Shigella sonnei in Ireland and Northern Ireland, December 2016: the benefits of cross-border collaboration and commercial sales data.

OBJECTIVES: To describe a cross-border foodborne outbreak of Shigella sonnei that occurred in Ireland and Northern Ireland (NI) in December 2016 whilst also highlighting the valuable roles of sales data and international collaboration in the investigation and control of this outbreak. STUDY DESIGN: A cross-border outbreak control team was established to investigate the outbreak. METHODS: Epidemiological, microbiological, and environmental investigations were undertaken. Traditional analytical epidemiological studies were not feasible in this investigation. The restaurant chain provided sales data, which allowed assessment of a possible increased risk of illness associated with exposure to a particular type of heated food product (product A). RESULTS: Confirmed cases demonstrated sole trimethoprim resistance: an atypical antibiogram for Shigella isolates in Ireland. Early communication and the sharing of information within the outbreak control team facilitated the early detection of the international dimension of this outbreak. A joint international alert using the European Centre for Disease Control's confidential Epidemic Intelligence Information System for Food- and Waterborne Diseases and Zoonoses (EPIS-FWD) did not reveal further cases outside of the island of Ireland. The outbreak investigation identified that nine of thirteen primary case individuals had consumed product A from one of multiple branches of a restaurant chain located throughout the island of Ireland. Product A was made specifically for this chain in a food production facility in NI. S. sonnei was not detected in food samples from the food production facility. Strong statistical associations were observed between visiting a branch of this restaurant chain between 5 and 9 December 2016 and eating product A and developing shigellosis. CONCLUSIONS: This outbreak investigation highlights the importance of international collaboration in the efficient identification of cross-border foodborne outbreaks and the value of using sales data as the analytical component of such studies.