A blended future? A cross-sectional study demonstrating the impacts of the COVID-19 pandemic on student experiences of well-being, teaching and learning.

INTRODUCTION: The COVID-19 pandemic necessitated emergency changes to teaching, learning and assessment across higher education. Healthcare courses were particularly affected because of their interdependence with overstretched health services. We used this unprecedented situation to provide insight into how students react to unexpected crises and how institutions can most effectively support them. MATERIALS AND METHODS: This cohort study explored students' experiences of the pandemic across programmes and stages from five schools (medicine, dentistry, biomedical sciences, psychology and health professions) in a health faculty in a UK university. We carried out an inductive thematic analysis on the data collected. RESULTS: Many students reported fluctuating emotions and struggled to adapt to home working. Students' changes in motivation and coping strategies varied, many found structure, recreation and social interaction important. Opinions on how well online learning worked relative to face-to-face diverged across programmes. CONCLUSION: A one-size-fits-all blended learning response is unlikely to be appropriate. Our study shows students across one faculty, within one institution, responded diversely to an emergency affecting them all. Educators need to be flexible and dynamic in delivering curricula and supporting students responding to an unexpected crisis during their higher education.

Maternal and neonatal complications in pregnancies with and without pre-gestational diabetes mellitus.

OBJECTIVES: To compare pregnancy complications in pregnancies with and without pre-gestational diabetes mellitus (DM) managed in a multidisciplinary high-risk diabetes antenatal clinic. METHODS: This screening cohort study was undertaken at a large maternity unit in the United Kingdom between January 2010 and December 2022. We included singleton pregnancies that booked at our unit at 11-13 weeks' gestation. Univariate and multivariate logistic regression analysis was carried out to determine risks of complications in pregnancies with type 1 and type 2 DM after adjusting for maternal and pregnancy characteristics. Effect sizes were expressed as absolute risks (AR) and odds ratio (OR) (95 % confidence intervals [CI]). RESULTS: The study population included 53,649 singleton pregnancies, including 509 (1.0 %) with pre-existing DM and 49,122 (99.0 %) without diabetes. Multivariate logistic regression analysis demonstrated that there was a significant contribution from pre-existing DM in prediction of adverse outcomes, including antenatal complications such as fetal defects, stillbirth, preterm delivery, polyhydramnios, preeclampsia and delivery of large for gestational age (LGA) neonates; intrapartum complications such as caesarean delivery (CS) and post-partum haemorrhage; and neonatal complications including admission to neonatal intensive care unit, hypoglycaemia, jaundice and hypoxic ischaemic encephalopathy (HIE). In particular, there was a 5-fold increased risk of stillbirth and HIE. CONCLUSIONS: The maternal and neonatal complications in pregnancies with pre-existing DM are significantly increased compared to those without DM despite a decade of intensive multidisciplinary antenatal care. Further research is required to investigate strategies and interventions to prevent morbidity and mortality in pregnancies with pre-gestational DM.

Perspectives on Sedation Among Interdisciplinary Team Members in ICU: A Survey Study.

OBJECTIVE: To explore the interdisciplinary team members' beliefs and attitudes about sedation when caring for mechanically ventilated patients in the ICU. DESIGN: Cross-sectional survey. SETTING: A 17-bed cardiothoracic ICU at a tertiary care academic hospital in Colorado. SUBJECTS: All nurses, physicians, advanced practice providers (APPs), respiratory therapists, physical therapists (PTs), and occupational therapists (OTs) who work in the cardiothoracic ICU. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We modified a validated survey instrument to evaluate perspectives on sedation across members of the interdisciplinary ICU team. Survey responses were collected anonymously from 111 members (81% response rate). Respondents were predominantly female (70 [63%]). Most respondents across disciplines (94%) believed that their sedation practice made a difference in patients' outcomes. More nurses (48%), APPs (62%), and respiratory therapists (50%) believed that sedation could help alleviate the psychologic stress that patients experience on the ventilator than physicians (19%) and PTs/OTs (0%) (p = 0.008). The proportion of respondents who preferred to be sedated if they were mechanically ventilated themselves varied widely by discipline: respiratory therapists (88%), nurses (83%), APPs (54%), PTs/OTs (38%), and physicians (19%) (p < 0.001). In our exploratory analysis, listeners of an educational podcast had beliefs and attitudes more aligned with best evidence-based practices than nonlisteners. CONCLUSIONS: We discovered significant interdisciplinary differences in the beliefs and attitudes regarding sedation use in the ICU. Since all ICU team members are involved in managing mechanically ventilated patients in the ICU, aligning the mental models of sedation may be essential to enhance interprofessional collaboration and promote sedation best practices.

Exploring basic science knowledge retention within a cohort of undergraduate medical students in the United Kingdom: A longitudinal study.

BACKGROUND: Clinical reasoning is reliant on students having acquired a strong foundation in the basic sciences. However, there remains uncertainty regarding whether medical students are maintaining this knowledge over the span of their degrees. Therefore, this project aimed to assess long-term retention of basic science knowledge within a cohort of students from an undergraduate medical school in the United Kingdom (UK). METHODS: This longitudinal study followed a cohort of students, from their first to final year. In their final year, participants sat a bespoke formative basic science knowledge assessment that utilised 46 single-best-answer questions. To examine for long-term attainment differences, these scores were compared with those achieved in first-year assessments. RESULTS: Of the eligible students, 40% partook in the study (n = 22). Comparing assessment scores highlighted an enhancement in overall basic science knowledge between first and final year (p < 0.01). Although most basic science domains remained unchanged between both time points, anatomy and physiology scores increased (p = 0.03 and p = 0.02, respectively), whereas biochemistry scores were the only ones to decrease (p = 0.02). DISCUSSION: This project provides insight into how well students are retaining the basic sciences during their studies. Underperforming science domains were identified, alongside pedagogical explanations for their individual shortcomings; for instance, students' perceived relevance of a domain is seen as a driver for its retention. Subsequently, a group of recommendations were derived to reinforce the most affected domains. The inclusion of more questions on the underperforming sciences, in clinically focussed assessments, is one such suggestion.

CD3+TCRαß/CD19+-Depleted Mismatched Family or Unrelated Donor Salvage Stem Cell Transplantation for Graft Dysfunction in Inborn Errors of Immunity.

A minority of children experience significant graft dysfunction after undergoing allogeneic hematopoietic stem cell transplantation (HSCT) for inborn errors of immunity (IEI). The optimal approach to salvage HSCT in this scenario is unclear with respect to conditioning regimen and stem cell source. This single-center retrospective case series reports the outcomes of salvage CD3+TCRαß/CD19-depleted mismatched family or unrelated donor stem cell transplantation (TCRαß-SCT) between 2013 and 2022 for graft dysfunction in 12 children with IEI. Outcomes of interest were overall survival (OS), event-free survival (EFS), graft-versus-host disease (GVHD)-free and event-free survival (GEFS), toxicities, GVHD, viremia and long-term graft function. In this retrospective audit of patients who underwent second CD3+TCRαß/CD19-depleted mismatched donor HSCT using treosulfan-based reduced-toxicity myeloablative conditioning, the median age at first HSCT was 8.76 months (range, 2.5 months to 6 years), and that at second TCRαß-SCT was 3.6 years (range, 1.2 to 11 years). The median interval between first and second HSCTs was 1.7 years (range, 3 months to 9 years). The primary diagnoses were severe combined immunodeficiency (SCID) (n = 5) and non-SCID IEI (n = 7). Indications for second HSCT were primary aplasia (n = 1), secondary autologous reconstitution (n = 6), refractory acute GVHD (aGVHD) (n = 3), and secondary leukemia (n = 1). Donors were either haploidentical parental donors (n = 10) or mismatched unrelated donors (n = 2). All patients received TCRαß/CD19-depleted peripheral blood stem cell (PBSC) grafts with a median CD34+ cell dose of 9.3 × 106/kg (range, 2.8 to 32.3 × 106/kg) and a median TCRαß+ cell dose of 4 × 104/kg (range, 1.3 to 19.2 × 104/kg). All patients engrafted, with a median time neutrophil and platelet recovery of 15 days (range, 12 to 24 days) and 12 days (range, 9 to 19 days). One patient developed secondary aplasia, and 1 had secondary autologous reconstitution; both underwent a successful third HSCT. Four (33%) had grade II aGVHD, and none had grade III-IV aGVHD. No patients had chronic GVHD (cGVHD), but 1 patient developed extensive cutaneous cGVHD after their third HSCT using PBSCs and antithymocyte globulin. Nine (75%) had at least 1episode of blood viremia with human herpesvirus 6 (n = 6; 50%), adenovirus (n = 6; 50%), Epstein-Barr virus (n = 3; 25%), or cytomegalovirus (n = 3; 25%). The median duration of follow-up was 2.3 years (range, .5 to 10 years), and the 2-year OS, EFS, and GEFS were 100% (95% confidence interval [CI], 0 to 100%), 73% (95% CI, 37% to 90%), and 73% (95% CI, 37% to 90%), respectively. TCRαß-SCT from mismatched family or unrelated donors, using a chemotherapy-only conditioning regimen, is a safe alternative donor salvage transplantation strategy for second HSCT in patients without a suitably matched donor.

Lessons from resistance analysis in clinical trials of IV zanamivir.

Influenza infection causes substantial morbidity and mortality during seasonal epidemics and pandemics. Antivirals, including neuraminidase inhibitors, play an important role in the treatment of severely ill patients infected with influenza. Resistance is a key factor that can affect the efficacy of neuraminidase inhibitors (NAIs). It is a recommendation by regulatory authorities to monitor for resistance during the development of anti-influenza medications. An additional requirement by regulators is to examine amino acid sequences for minority species harbouring resistance substitutions. In a Phase III study of intravenous (IV) zanamivir respiratory samples were analysed for the presence of resistant quasi species using Next Generation Sequencing (NGS). In this study ten resistance substitutions, two of which were treatment emergent, were detected by NGS that otherwise would not have been detectable by Sanger sequencing. None of the substitutions were present at any other timepoints analysed. The effect these mutations have on clinical response is difficult to characterize; in fact, all patients from which these variants were isolated had a successful clinical outcome and the effect on clinical response was therefore likely minimal. Although NGS is becoming a routine method for nucleic acid sequencing and will detect substitutions previously undetected by Sanger sequencing, the value of this technique in identifying minority species with resistance substitutions that are clinically meaningful remains to be demonstrated, particularly with acute infections such as influenza.

"Everything is revolved around me being heavy it's always, always spoken about." Qualitative experiences of weight management during pregnancy in women with a BMI of 40kg/m2 or above.

INTRODUCTION: Maternal weight management services have been recognised as a good opportunity to influence lifestyle and dietary behaviour of mothers and families. Exploring women's views of maternal weight management services is paramount to understand what constitutes the most suitable service. This study therefore explored experiences among women with a raised body mass index (BMI) of maternal weight management service provision and the barriers and facilitators to weight management during pregnancy. METHOD: Thirteen women with a BMI≥40kg/m² undertook semi-structured interviews around weight management experiences during pregnancy. Interviews were audio recorded and transcribed verbatim. Inductive thematic analysis was undertaken. RESULTS: Four themes emerged. 1). "Understanding where I am at" showed current readiness and motivation of women varied, from being avoidant to being motivated to make changes. 2). "Getting information" revealed inconsistent information provision during pregnancy. Women particularly wanted practical advice. Some attempted to find this for themselves from friends or the internet, however this left some women feeling confused when different sources provided inconsistent advice. 3). "Difficulties I face" identified physical, emotional and financial barriers and the strategies some women used to overcome these. 4). "Encountering professionals-a mixed experience" demonstrated women wanted to be treated with respect and sensitivity and that how weight management information was addressed was more important than who provided it. The fine line professionals tread was demonstrated by women thinking that they had received inadequate information and yet too much focus was placed on their weight and the associated risks during pregnancy without practical solutions to their weight management challenges. DISCUSSION: Women were empowered when practical advice was provided, not just the continual repetition of the risks of being obese during pregnancy. Antenatal weight management services need to be clear, sensitive and respectful. Services centred on individual women's needs and on their current and previous experiences are required. The psychological and social contexts of weight management also need to be addressed.

A special issue of Essays in Biochemistry on current educational developments in molecular bioscience.

The 4th joint UK Biochemical Society and Federation of European Biochemical Societies (FEBS) education event, 'Evolving Molecular Bioscience Education' took place online on May 27 and 28, 2021. The event, continuing the biennial series, comprised the invited speakers' talks, group discussions and other participants' pre-recorded flash presentations. Although the UK dominated, there were also speakers and participants from other European countries and other continents. This special issue includes a varied collection of articles written by the speakers and other participants.

'Everyone is trying to outcompete each other': a qualitative study of medical student attitudes to a novel peer-assessed undergraduate teamwork module.

The centrality of teamwork in ensuring the effective functioning of institutions across all sectors is undeniable. However, embedding teamwork into higher education has been hampered due to a range of deeply entrenched practices associated broadly with the foregrounding of knowledge, beliefs about the place of skill training and routines of assessment. As a result, despite an urgent need to address teamwork, little progress has been made with respect to progressing teamwork education. We have designed and evaluated a novel teamwork module delivered to fourth-year undergraduate medical students involving placements, a cocreated piece of work, reflection and summative peer assessment. This paper aimed to investigate whether the module increased students' insight into teamwork, including their own skill development, and whether their perceptions of teamwork changed. Throughout the evaluation, students played a key role, with four final-year medical students working alongside others in the multidisciplinary project team. Five distinct themes emerged from our in-depth, semi-structured interviews: (a) importance and meaning; (b) insight into skill development; (c) transferability; (d) peer assessment; and (e) resistance to teamwork education. Themes had positive and negative components, and student perceptions changed in multiple ways after experiencing a longitudinal educational opportunity to develop their teamwork skills. Before practice, students focused on superficial explanations and on where they might improve. In contrast, after practice, students conveyed deeper insights, contextualisation, focus on how they might improve, and shared structured reflection.

Biogeochemical impacts of sewage effluents in predominantly rural river catchments: Are point source inputs distinct to background diffuse pollution?

Discharge of treated sewage effluent to rivers can degrade aquatic ecosystem quality, interacting with multiple stressors in the wider catchment. In predominantly rural catchments, the river reach influence of point source effluents is unknown relative to complex background pressures. We examined water column, sediment and biofilm biogeochemical water quality parameters along river transects (200 m upstream to 1 km downstream) during summer at five wastewater treatment works (WWTW) in Scotland. Treated sewage effluent (subset, n = 3) pollutant concentrations varied between sites. Downstream concentration profiles of water and sediment biogeochemical parameters showed complex spatial changes. A hypothesised point source signature of elevated concentrations of pollution immediately downstream of WWTW then a decaying pollution 'plume' did not commonly occur. Instead, elevated soluble reactive phosphorus (SRP), ammonium and coliforms (maximum 0.23 mgP/l, 0.33 mgN/l and >2 × 106 MPN/100 ml) occurred immediately downstream of two WWTW, whereas some downstream pollutant concentrations decreased. Microbial substrate respiration responses only differed 1 km downstream. Significantly greater concentrations of sediment metal occurred >500 m downstream, likely due to the redeposition of historic contaminated sediments. Significantly lowered chlorophyll-a downstream of one WWTW coincided with elevated metals, despite water SRP and sediment P increases. Overall, stress caused to microbes and algae by effluent contaminants outweighed the subsidy effect of WWTW nutrients. We observed variable effluent flows to the rivers limited localised pollution downstream of WWTW and overall influence of arable land cover on river water quality. Together, this challenges views of consistently discharging point sources impacting low dilution sensitive rivers in summer contrasting with 'diffuse' sources. Thus, river water column and benthic compartments are altered at varying scales by point source effluents in combination with rural catchment pollution sources, both discrete (e.g. farmyards and septic tanks) and diffuse.

'It is difficult to think about becoming what you have never seen': Black students' reflections around a career in academic dentistry.

This opinion piece considers the national representation of the Black population in the United Kingdom in an academic career in dentistry and draws on engagement with Black dental students to see what their perceptions of this are. Black people are under-represented in dentistry as a whole and the number of Black academics who teach dentistry to an increasing number of aspiring young Black dental students is exceedingly low. Black dental students do not see themselves represented by their teachers and therefore 'it is difficult to think about [them] becoming what [they] have never seen'. Black dental students themselves have started initiatives to establish a strong support network of aspiring and qualified Black dentists. Dialogue with them showcases that while there are pathways into an academic career in dentistry, these appear unclear to them. This piece is intended to raise awareness of these issues, in the knowledge that with mentoring, role modelling and dialogue, pathways may become clearer, opportunities may arise that were previously not considered and the national picture may one day change.

The evolving role of weather types on rainfall chemistry under large reductions in pollutant emissions.

Long-term change and shorter-term variability in the atmospheric deposition of pollutants and marine salts can have major effects on the biogeochemistry and ecology of soils and surface water ecosystems. In the 1980s, at the time of peak acid deposition in the UK, deposition loads were highly dependent on prevailing weather types, and it was postulated that future pollution recovery trajectories would be partly dependent on any climate change-driven shifts in weather systems. Following three decades of substantial acidic emission reductions, we used monitoring data collected between 1992 and 2015 from four UK Environmental Change Network (ECN) sites in contrasting parts of Great Britain to examine the trends in precipitation chemistry in relation to prevailing weather conditions. Weather systems were classified on the basis of Lamb weather type (LWT) groupings, while emissions inventories and clustering of air mass trajectories were used to interpret the observed patterns. Concentrations of ions showed clear differences between cyclonic-westerly-dominated periods and others, reflecting higher marine and lower anthropogenic contributions in Atlantic air masses. Westerlies were associated with higher rainfall, higher sea salt concentrations, and lower pollutant concentrations at all sites, while air mass paths exerted additional controls. Westerlies therefore have continued to favour higher sea salt fluxes, whereas emission reductions are increasingly leading to positive correlations between westerlies and pollutant fluxes. Our results also suggest a shift from the influence of anthropogenic emissions to natural emissions (e.g., sea salt) and climate forcing as they are transported under relatively cleaner conditions to the UK. Westerlies have been relatively frequent over the ECN monitoring period, but longer-term cyclicity in these weather types suggests that current contributions to precipitation may not be sustained over coming years.

T-replete HLA-matched grafts vs T-depleted HLA-mismatched grafts in inborn errors of immunity.

Hematopoietic cell transplantation (HCT) has become standard-of-care for an increasing number of inborn errors of immunity (IEI). This report is the first to compare transplant outcomes according to T-cell-replete (ie, T-replete) HLA-matched grafts using alemtuzumab (n = 117) and T-cell-depleted (ie, T-depleted) HLA-mismatched grafts using T-cell receptor-αß (TCRαß)/CD19 depletion (n = 47) in children with IEI who underwent first HCT between 2014 and 2019. All patients received treosulfan-based conditioning except patients with DNA repair disorders. For T-replete grafts, the stem cell source was marrow in 25 (21%) patients, peripheral blood stem cell (PBSC) in 85 (73%), and cord blood in 7 (6%). TCRαß/CD19 depletion was performed on PBSCs from 45 haploidentical parental donors and 2 mismatched unrelated donors. The 3-year overall survival (OS) and event-free survival for the entire cohort were 85% (77%-90%) and 79% (69%-86%), respectively. Analysis according to age at transplant revealed a comparable 3-year OS between T-replete grafts (88%; 76%-94%) and T-depleted grafts (87%; 64%-96%) in younger patients (aged <5 years at HCT). For older patients (aged >5 years), the OS was significantly lower in T-depleted grafts (55%; 23%-78%) compared with T-replete grafts (87%; 68%-95%) (P = .03). Grade III to IV acute graft-versus-host disease was observed in 8% of T-replete marrow, 7% of T-replete PBSC, 14% of T-replete cord blood, and 2% of T-depleted PBSC (P = .73). Higher incidence of viremia (P < .001) and delayed CD3 reconstitution (P = .003) were observed after T-depleted graft HCT. These data indicate that mismatched donor transplant after TCRαß/CD19 depletion represents an excellent alternative for younger children with IEI in need of an allograft.

Teaching, research or balanced? An exploration of the experiences of biomedical scientists working in UK medical schools.

Driven by demand for high standards in university education, efforts have been made in the UK to address the perceived imbalance between teaching and research. However, teaching is still perceived by many as having less credibility and is attributed less importance. The purpose of our research was to explore how distinct types of academic job profiles ('research' or 'education' focused, or 'balanced') impact on biomedical scientists' perceptions of the lecturer role. Specifically, we investigated the experiences of biomedical scientists in 'post-1990' medical schools, which are known for their commitment to excellence in both research and education. We conducted 22 face-to-face, semi-structured interviews with biomedical scientists in five schools. Focusing on experiences of work, the interviews covered: 'motivations', 'role expectations', 'teaching', 'research' and 'career'. The recorded qualitative data were transcribed and then analysed thematically. Our results, offering an insight into the working lives of biomedical scientists in medical education, suggest that in settings with a dual emphasis on education and research, individuals on 'balanced' contracts can experience a strong pull between research and teaching. In addition to posing significant challenges with respect to workload management, this can impact profoundly on professional identity. In contrast to the balanced role, 'research' or 'education' focused roles appear to have clearer requirements, leading to higher employee satisfaction. We conclude that to assist the educational mission of Higher Education, attention should be paid to balanced contracts, to (a) ensure employee support, (b) mitigate against negative perceptions of teaching, and ultimately, (c) guard against staff attrition.

Spatial representation of in-stream sediment phosphorus release combining channel network approaches and in-situ experiments.

Impairment of rivers by elevated phosphorus (P) concentration is an issue often studied at outlets of mesoscale catchments. Our objective was to evaluate within-catchment spatio-temporal processes along connected reaches to understand processes of internal P loading associated with sediment input, accumulations in channels and sediment-water column P exchange. Our overall hypothesis was that heterogeneous sediment residence within the channel of a 52 km2 mixed land cover catchment resulted in key zones for sediment-water P exchange. We evaluated the channel network through ground-survey, spatial data methods establishing connectivity and energy gradients. This gave a background to understand sampling of sediments and P release/uptake to the water column using 90 s in-situ resuspension isolating a portion of streambed over five sets of three-location transects in May (spring storms, recent active erosion) and September (summer low flow, longer sediment residence). Simple transect position models (top, mid, bottom) predicted increased sediment resuspension yields and P contents in lower settings. Sediment P release following resuspension were mean (and range) 0.5 (-0.8 to 1.8) and 0.5 (-2.5 to 3.6) mg soluble reactive P/m2 bed in May and September, respectively, strengthening generally down the transects but inconsistently. Relationships (log form) showed a steepening rise in fine sediments, P content, background and disturbance-released dissolved P, with specific stream power < 40 W/m2. In-situ methods showed sediments dominantly (12 cases May, 13 cases Sep) as P sources capable of influencing dissolved P concentrations and with potential explanation that heterogeneous locations of internal P loading influence the systems longer-term observed P trends. Combining channel network, stream power assessment and in-situ sorption studies improved the understanding of influential zones of sediment-water P exchange within this mesoscale catchment. Such methods have potential to inform P model development and management.

Midwives' experiences of cultural competency training and providing perinatal care for migrant women a mixed methods study: Operational Refugee and Migrant Maternal Approach (ORAMMA) project.

BACKGROUND: The number of international migrants continues to increase worldwide. Depending on their country of origin and migration experience, migrants may be at greater risk of maternal and neonatal morbidity and mortality. Having compassionate and culturally competent healthcare providers is essential to optimise perinatal care. The "Operational Refugee and Migrant Maternal Approach" (ORAMMA) project developed cultural competence training for health professionals to aid with providing perinatal care for migrant women. This presents an evaluation of ORAMMA training and explores midwives' experiences of the training and providing care within the ORAMMA project. METHODS: Cultural competence was assessed before and after midwives (n = 35) received ORAMMA compassionate and culturally sensitive maternity care training in three different European countries. Semi-structured interviews (n = 12) explored midwives' experiences of the training and of caring for migrant women within the ORAMMA project. RESULTS: A significant improvement of the median score pre to post-test was observed for midwives' knowledge (17 to 20, p < 0.001), skills (5 to 6, p = 0.002) and self-perceived cultural competence (27 to 29, p = 0.010). Exploration of midwives' experiences of the training revealed themes of "appropriate and applicable", "made a difference" and "training gaps" and data from ORAMMA project experiences identified three further themes; "supportive care", "working alongside peer supporters" and "challenges faced". CONCLUSIONS: The training improved midwives' knowledge and self-perceived cultural competence in three European countries with differing contexts and workforce provision. A positive experience of ORAMMA care model was expressed by midwives, however clearer expectations of peer supporters' roles and more time within appointments to assess the psychosocial needs of migrant women were desired. Future large-scale research is required to assess the long-term impact of the ORAMMA model and training on practice and clinical perinatal outcomes.

Standard setting anchor statements: a double cross-over trial of two different methods.

This article was migrated. The article was marked as recommended. Context: We challenge the philosophical acceptability of the Angoff method, and propose an alternative method of standard setting based on how important it is for candidates to know the material each test item assesses, and not how difficult it is for a subgroup of candidates to answer each item. Methods: The practicalities of an alternative method of standard setting are evaluated here, for the first time, with direct comparison to an Angoff method. To negate bias due to any leading effects, a prospective cross-over design was adopted involving two groups of judges (n=7 and n=8), both of which set the standards for the same two 100 item multiple choice question tests, by the two different methods. Results: Overall, we found that the two methods took a similar amount of time to complete. The alternative method produced a higher cut-score (by 12-14%), and had a higher degree of variability between judges' cut-scores (by 5%). When using the alternative method, judges reported a small, but statistically significant, increase in their confidence to decide accurately the standard (by 3%). Conclusion: This is a new approach to standard setting where the quantitative differences are slight, but there are clear qualitative advantages associated with use of the alternative method.

Omega-3 fatty acid supplementation for cystic fibrosis.

BACKGROUND: Studies suggest that a diet rich in omega-3 essential fatty acids may have beneficial anti-inflammatory effects for chronic conditions such as cystic fibrosis. This is an updated version of a previously published review. OBJECTIVES: To determine whether there is evidence that omega-3 polyunsaturated fatty acid supplementation reduces morbidity and mortality and to identify any adverse events associated with supplementation. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of last search: 01 April 2020. We also searched online study registries and contacted authors. Date of last search: 12 February 2020. SELECTION CRITERIA: Randomised controlled trials in people with cystic fibrosis comparing omega-3 fatty acid supplements with placebo. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion, extracted data and assessed the risk of bias of the studies. The quality of the evidence was assessed using GRADE. MAIN RESULTS: The searches identified 23 studies; five studies with 106 participants (children and adults) were included; duration of studies and interventions differed. Two studies compared omega-3 fatty acids to olive oil for six weeks; one study compared omega-3 fatty acids and omega-6 fatty acids to control capsules (customised fatty acid blends) for three months; one study compared a liquid dietary supplement containing omega-3 fatty acids to one without for six months; and one study compared omega-3 fatty acids to a placebo for 12 months. Three studies had a low risk of bias for randomisation, but the risk was unclear in the remaining two studies; all studies had an unclear risk of bias for allocation concealment. Three of the studies adequately blinded participants; the risk of bias for selective reporting was high in one study and unclear for four studies. Two studies reported the number of respiratory exacerbations. At three months, one study (43 participants) reported no change in antibiotic usage. At 12 months the second study (15 participants) reported a reduction in the number of pulmonary exacerbations and cumulative antibiotic days in the supplement group compared to the previous year (no data for the control group); very low-quality evidence means we are unsure whether supplementation has any effect on this outcome. With regards to adverse events, one six-week study (12 participants) reported no difference in diarrhoea between omega-3 or placebo capsules; the very low-quality evidence means we are unsure if supplementation has any effect on this outcome. Additionally, one study reported an increase in steatorrhoea requiring participants to increase their daily dose of pancreatic enzymes, but three studies had already increased pancreatic enzyme dose at study begin so as to reduce the incidence of steatorrhoea. One study (43 participants) reported stomach pains at three months (treatment or control group not specified). One six-week study (19 participants) reported three asthma exacerbations leading to exclusion of participants since corticosteroid treatment could affect affect essential fatty acid metabolism. Four studies reported lung function. One six-week study (19 participants) reported an increase in forced expiratory volume in one second (FEV1) (L) and forced vital capacity (FVC) (L), but the very low-quality evidence means we are unsure if supplementation has any effect on lung function. The remaining studies did not report any difference in lung function at three months (unit of measurement not specified) or at six months and one year (FEV1 % predicted and FVC % predicted). No deaths were reported in any of the five studies. Four studies reported clinical variables. One study reported an increase in Schwachman score and weight alongside a reduction in sputum volume with supplementation compared to placebo at three months (data not analysable). However, three studies reported no differences in either weight at six weeks, in body mass index (BMI) standard deviation (SD) score at six months (very low-quality evidence) or BMI Z score at 12 months. Three studies reported biochemical markers of fatty acid status. One study showed an increase from baseline in both EPA and DHA content of serum phospholipids in the omega-3 group compared to placebo at three months and also a significant decrease in n-6/n-3 ratio in the supplement group compared to placebo; since the quality of the evidence is very low we are not certain that these changes are due to supplementation. One six-month cross-over study showed a higher EPA content of the neutrophil membrane in the supplement group compared to the placebo group, but, no difference in DHA membrane concentration. Furthermore, the leukotriene B4 to leukotriene B5 ratio was lower at six months in the omega-3 group compared to placebo. A one-year study reported a greater increase in the essential fatty acid profile and a decrease in AA levels in the treatment arm compared to placebo. AUTHORS' CONCLUSIONS: This review found that regular omega-3 supplements may provide some limited benefits for people with cystic fibrosis with relatively few adverse effects: however, the quality of the evidence across all outcomes was very low. The current evidence is insufficient to draw firm conclusions or recommend routine use of these supplements in people with cystic fibrosis. A large, long-term, multicentre, randomised controlled study is needed to determine any significant therapeutic effect and to assess the influence of disease severity, dosage and duration of treatment. Future researchers should note the need for additional pancreatic enzymes when providing omega-3 supplementation or olive oil placebo capsules. More research is required to determine the exact dose of pancreatic enzyme required.