Improving ethnicity data collection and ethnic minority participation in randomised clinical trials

UK ethnic minority patients are reported to be under-represented in clinical trials. Under-representation of any patient group within an Randomised Clinical Trial can bias trial results and subsequent extrapolation into the general population. However, the true extent of ethnic minority representation in RCTs is masked by the poor quality of ethnicity data. This thesis investigates ethnicity data collection in healthcare and the representation of ethnic minority patients in RCTs in the UK. A systematic literature review of ethnicity data collection identified a paucity of published evidence. Self-reported ethnicity was recognised as the optimal method of data collection but training is needed to raise awareness of the importance of such data. Reasons for the gaps in ethnicity data were explored through a healthcare professional survey and focus groups with lay South Asian volunteers. The majority of healthcare professionals agreed it was important to collect ethnicity and emphasised the need for training. The focus groups revealed a willingness to provide these data, subject to being given information regarding their use. A second systematic literature review of interventions to improve recruitment and retention of ethnic minorities to RCTs found a dearth of literature from the UK. US studies reported financial incentives, government grants and the involvement of community representatives to be effective. Census data, hospital episode statistics data, clinical trials recruitment and reasons for non-participation, collected in one cancer research network, were used to assess the local representation of ethnic minorities within RCTs. The results did not show ethnic minorities to be under-represented, but there was insufficient evidence to rule out under-representation as a problem. Reducing inequalities in participation in clinical trials is dependent upon having accurate and complete ethnicity data. A change in policy to mandate the collection of ethnicity data in primary care and linked through to other healthcare service providers is required

Chorioangioma of the placenta with hydrops foetalis

Chorioangioma, the non trophoblastic tumour, constitutes the commonest benign growth of the placenta. Though benign, 30% rate of maternal or foetal complications are associated with large masses. Sonography including colour Doppler imaging provides the best modality not only for its diagnosis but also the foetal status. A case of large placental chorioangioma has been reported here resulting in dismal foetal outcome diagnosed on antenatal ultrasound

Chest wall schwannoma: Case report and a review of imaging findings

A chest wall schwannoma arises from peripheral nerve sheath Schwann cells of the intercostal nerves. We describe the presentation and imaging findings of a patient who presented with a chest wall swelling. The imaging findings were highly suspicious for a chest wall schwannoma and the histopathology confirmed the diagnosis following surgical excision. Imaging findings are reviewed in detail

Cesarean scar pregnancy: an experience of three cases with review of literature

Cesarean scar pregnancy (CSP), often considered the rarest form of ectopic pregnancy, is a result of implantation of the gestational sac into the fibrous tissue scar of a previous cesarean section. With an increase in the rate of cesarean sections, along with better awareness and improvement in sonographic diagnosis, the number and detection of scar pregnancies are on the rise. Because of its early invasion of the myometrium, usually in the first trimester, CSP is considered to be potentially lethal, leading to high risks of uterine rupture. We report a series of three cases of scar pregnancy that presented at different gestational ages and were managed by different methods. The aim of this case series is to share our experience with CSP, review previous literature, and emphasize on the radiological criteria to making a confident diagnosis. Diagnosis and management of CSP needs considerable expertise and a multidisciplinary approach to prevent complications. KEYWORDS

Improving ethnic data collection for statistics of cancer incidence, management, mortality and survival in the UK

Background: • Ethnic record keeping and monitoring has been identified as being important for over the past 20 years and has often been associated with negative rather than positive reasons • There is an identified need for the collection of ethnicity in healthcare settings • There is an “Evidence desert” with few “best practice reports” • There have been recent initiatives to collect ethnicity through Hospital Admissions (e.g. Hospital Episode Statistics) and Primary Care Findings of this feasibility project: Systematic review: • There is a paucity of published evidence regarding methodology of ethnicity data collection or ethnicity profiling • Many clinical articles use ethnicity data in their analyses, health surveys or risk assessment of particular diseases, but often the data are of variable quality • Self assessed ethnicity is better than observer assessment • Official ethnicity categories need to be re-examined and modified to represent new migration patterns Professional perception: • Lack of consistency at different levels of organisations • No clear rationale for collection/use of data • Data collected without training or explanation of its use • Not enough resources for ‘research data’ in general, without adding ethnicity Focus groups perception: • No objections to providing data in a healthcare setting • Willingness to engage in research • Lack of information as to the use of the data Groups actively looking at how to collect and use ethnicity data • South Thames registry looking at cancer rates for South Asians • Healthy Londoners’ project and London Public Health Observatory initiatives • Census categories extended to capture ‘British Born’ groups • Specialist libraries and JISC-mail electronic discussion groups already set up Recommendations – need for better training and information • Need training materials/workshops to raise awareness - Patients- why your doctor should know your ethnic group? - Professionals- how to ask and explain the importance of ethnicity data collection? • Work towards a culture of routine data collection of ethnicity at GP level • Need working groups to assess collection, completeness and validation • Need more reporting of ethnicity data in the healthcare setting, in order to improve planning and delivery of services for ethnic minority group

Ethnicity data collection in the UK: the healthcare professional's perspective

The collection of ethnicity data has been demonstrated to be important in healthcare. However, despite recent efforts by the UK government, it remains incomplete and unvalidated. In order to be able to assess inequalities and target resources appropriately, it is essential to have complete and accurate data. This paper examines the reasons for the gaps in ethnicity data based on the perceptions and experiences of the healthcare professionals who are charged with collecting these data. A questionnaire was used to assess perceptions of ethnicity data collection, including any barriers encountered as well as the perceived importance of collecting these data. Respondents were asked whether routine ethnicity data collection was limited to specific disease areas, and approximately what proportion was complete in these areas. There were also questions concerning preferred methods of collection (e.g. self-report). The questionnaire was completed by 30 respondents, who included healthcare managers, clinicians, nurses and other staff working in the healthcare setting. The findings confirmed that the collection of patients’ ethnicity data is deemed important by the healthcare professionals, but showed that there remains uncertainty and unease as to how best to collect these data or how to explain to patients how the data will be used. The majority of healthcare professionals agreed that it was important to record patients’ ethnicity, but no clear rationale was given to staff about the use of these data, and no training was provided on the best way to collect the data.</p

Presenting Symptoms in Newly Diagnosed Myeloma, Relation to Organ Damage, and Implications for Symptom-Directed Screening: A Secondary Analysis from the Tackling Early Morbidity and Mortality in Myeloma (TEAMM) Trial

Multiple myeloma (MM) patients risk diagnostic delays and irreversible organ damage. In those with newly diagnosed myeloma, we explored the presenting symptoms to identify early signals of MM and their relationships to organ damage. The symptoms were recorded in patients’ own words at diagnosis and included diagnostic time intervals. Those seen by a haematologist >6 months prior to MM diagnosis were classified as precursor disease (PD). Most (962/977) patients provided data. Back pain (38%), other pain (31%) and systemic symptoms (28%) predominated. Patients rarely complain of ‘bone pain’, simply ‘pain’. Vertebral fractures are under-recognised as pathological and are the predominant irreversible organ damage (27% of patients), impacting the performance status (PS) and associated with back pain (odds ratio (OR) 6.14 [CI 4.47–8.44]), bone disease (OR 3.71 [CI 1.88–7.32]) and age >65 years (OR 1.58 [CI 1.15–2.17]). Renal failure is less frequent and associated with gastrointestinal symptoms (OR 2.23 [CI1.28–3.91]), age >65 years (OR 2.14 [CI1.28–3.91]) and absence of back pain (OR 0.44 [CI 0.29–0.67]). Patients with known PD (n = 149) had fewer vertebral fractures (p = 0.001), fewer adverse features (p = 0.001), less decline in PS (p = 0.001) and a lower stage (p = 0.04) than 813 with de novo MM. Our data suggest subgroups suitable for trials of ‘symptom-directed’ screening: those with back pain, unexplained pain, a general decline in health or low-impact vertebral compression fractures

Elicitation of the in vitro Cultures of Selected Varieties of Vigna radiata L. With Zinc Oxide and Copper Oxide Nanoparticles for Enhanced Phytochemicals Production

This study was conducted to develop a protocol for in vitro shoot multiplication and callus induction of various mung bean varieties to obtain enhanced phytochemical content with the help of elicitors. For shoot multiplication, two types of explants (shoot tips and nodal tips) of three varieties of mung bean (Mung NCM-13, MgAT-7, and MgAT-4) were used. Both types of explants from in vitro and in vivo sources were cultured on the MS medium supplemented with different concentrations (0.25–3.0 mg/L, increment of 0.5 mg/L) and combinations of BAP and IBA as independent treatments. For callus induction, leaf explants (in vitro source) were cultured on MS medium supplemented with 2,4-D (1–3 mg/L) alone or in combination with BAP or NAA (0.5 and 1.0 mg/L). For the enhanced production of phenolics and glycosides, calli were cultured on MS media supplemented with zinc oxide (0.5 mg/L) and copper oxide nanoparticles (0.5 mg/L) as nano-elicitors. Results showed that in vitro explants responded better in terms of shoot length, number of shoots, and number of leaves per explant when compared to in vivo explants. Moreover, shoot tips were better than nodal explants to in vitro culturing parameters. All three varieties showed the optimized results in the MS medium supplemented with 1 mg/L BAP, while roots were produced only in cultures fortified with 1 mg/L IBA. The leaf explants of in vitro and soil-grown plantlets showed a maximum callogenic response of 90 and 80%, respectively, on MS medium supplemented with 2,4-D (3 mg/ml). Maximum phenolic content (101.4 μg of gallic acid equivalent/g) and glycoside content (34 mg of amygdalin equivalent/g of plant material) was observed in the calli cultured on MS medium supplemented with 3 mg/L of 2,4-D. Furthermore, the addition of zinc oxide (0.5 mg/L) and copper oxide (0.5 mg/L) nanoparticles to the callus culture medium significantly enhanced the phenolic content of Mung NCM-13 (26%), MgAT-7 (25.6%), and MgAT-4 (22.7%). Glycosidic content was also found to be increased in Mung NCM-13 (50%), MgAT-7 (37.5%), and MgAT-4 (25%) varieties when compared to the control. It is suggested that elicitation of in vitro cultures of mung beans with nanoparticles could be an effective strategy for the enhanced production of secondary metabolites

Transient ischemic stroke triggers sustained damage of the choroid plexus blood-CSF barrier

Neuroinflammation is a pathological event associated with many neurological disorders, including dementia and stroke. The choroid plexus (ChP) is a key structure in the ventricles of the brain that secretes cerebrospinal fluid (CSF), forms a blood-CSF barrier, and responds to disease conditions by recruiting immune cells and maintaining an immune microenvironment in the brain. Despite these critical roles, the exact structural and functional changes to the ChP over post-stroke time remain to be elucidated. We induced ischemic stroke in C57BL/6J mice via transient middle cerebral artery occlusion which led to reduction of cerebral blood flow and infarct stroke. At 1–7 days post-stroke, we detected time-dependent increase in the ChP blood-CSF barrier permeability to albumin, tight-junction damage, and dynamic changes of SPAK-NKCC1 protein complex, a key ion transport regulatory system for CSF production and clearance. A transient loss of SPAK protein complex but increased phosphorylation of the SPAK-NKCC1 complex was observed in both lateral ventricle ChPs. Most interestingly, stroke also triggered elevation of proinflammatory Lcn2 mRNA and its protein as well as infiltration of anti-inflammatory myeloid cells in ChP at day 5 post-stroke. These findings demonstrate that ischemic strokes cause significant damage to the ChP blood-CSF barrier, contributing to neuroinflammation in the subacute stage

Clinical characteristics and outcomes of IgD myeloma: experience across UK national trials

© 2022 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.Immunoglobulin D (IgD) myeloma is a subtype often considered to have adverse features and inferior survival, but there is a paucity of data from large clinical studies. We compare the clinical characteristics and outcomes of patients with IgD myeloma from UK phase 3 myeloma trials analyzed in 2 groups: old (1980-2002) and recent (2002-2016) clinical trials, based on the time of adoption of novel myeloma therapies. Patients with IgD myeloma comprised 44 of 2789 (1.6%) and 70 of 5773 (1.2%) of the old and recent trials, respectively. Overall, IgD myeloma was associated with male predominance, low-level paraproteinemia (,10g/L), and l light chain preference. The frequency of ultra-high-risk cytogenetics was similar in IgD myeloma compared with other subtypes (4.3% vs 5.3%, P . .99). Despite the old trial series being a younger group (median age: 59 vs 63 years, P 5 .015), there was a higher frequency of bone lesions, advanced stage at diagnosis, worse performance status, and severe renal impairment compared with the recent trials. Furthermore, the early mortality rate was significantly higher for the old trial series (20% vs 4%, P 5 .01). The overall response rate following induction therapy was significantly higher in the recent trials (89% vs 43%, P, .0001), and this was consistent with improved median overall survival (48 months; 95% confidence interval [CI] 35-67 months vs 22 months; 95% CI, 16-29 months). Survival outcomes for IgD myeloma have significantly improved and are now comparable to other myeloma types because of earlier diagnosis, novel therapies, and improved supportive care.Published versio