Did the COVID-19 pandemic affect levels of burnout, anxiety and depression among doctors and nurses in Bangladesh? A cross-sectional survey study.

INTRODUCTION: COVID-19 has caused severe disruption to clinical services in Bangladesh but the extent of this, and the impact on healthcare professionals is unclear. We aimed to assess the perceived levels of anxiety, depression and burnout among doctors and nurses during COVID-19 pandemic. METHODS: We undertook an online survey using RedCap, directed at doctors and nurses across four institutions in Bangladesh (The Sheikh Russel Gastro Liver Institute & Hospital (SRNGIH), Dhaka Medical College Hospital (DMCH), Mugda Medical College Hospital (MMCH) and M Abdur Rahim Medical College (MARMC) Hospital). We collected information on demographics, awareness of well-being services, COVID-19-related workload, as well as anxiety, depression and burnout using two validated questionnaires: the Hospital Anxiety and Depression Scale (HADS) and the Maslach Burnout Inventory (MBI). RESULTS: Of the 3000 participants approached, we received responses from 2705 (90.2%). There was a statistically significant difference in anxiety, depression and burnout scores across institutions (p<0.01). Anxiety, depression and burnout scores were statistically worse in COVID-19 active staff compared with those not working on COVID-19 activities (p<0.01 for HADS anxiety and depression and MBI emotional exhaustion (EE), depersonalisation (DP) and personal accomplishment (PA)). Over half of the participants exhibited some level of anxiety (SRNGIH: 52.2%; DMCH: 53.9%; MMCH: 61.3%; MARMC: 68%) with a high proportion experiencing depression (SRNGIH: 39.5%; DMCH: 38.7%; MMCH: 53.7%; MARMC: 41.1%). Although mean burnout scores were within the normal range for each institution, a high proportion of staff (almost 20% in some instances) were shown to be classified as experiencing burnout by their EE, DP and PA scores. CONCLUSION: We identified a high prevalence of perceived anxiety, depression and burnout among doctors and nurses during the COVID-19 pandemic. This was worse in staff engaged in COVID-19-related activities. These findings could help healthcare organisations to plan for future similar events.

Patient and healthcare professionals' perceptions of a combined blood and faecal immunochemical test for excluding colorectal cancer diagnosis in primary care.

OBJECTIVES: To explore the perceptions of patients and healthcare professionals on Raman-faecal immunochemical test (FIT) as an alternative test for colorectal cancer exclusion in primary care. DESIGN: Semi-structured interviews within a feasibility study. SETTING: Patients presenting to primary care with colorectal symptoms and healthcare professionals working in primary and secondary care. PARTICIPANTS: A total of 23 patients and 12 healthcare professionals. METHODS: Patient participants were asked to complete a novel combined Raman-FIT test before being seen in secondary care. This study sought their opinions about the test. We also sought the views of healthcare professionals. FINDINGS: Patients and healthcare professionals agreed that Raman-FIT was a suitable test to be given in primary care. It aligned with routine practice and was a simple test for most patients to complete. CONCLUSIONS: Patients are willing and able to complete the Raman-FIT test in primary care. Raman-FIT may accelerate access to diagnosis with the potential to improve cancer outcomes. PATIENT AND PUBLIC INVOLVEMENT: Lay members (J. H. and I. H.) with experience and knowledge of colorectal cancer and screening contributed to developing, undertaking, and disseminating all aspects of the research. They were supported to collaborate as equal members of the research team. They were involved in developing the study as coapplicants, using personal experience to ensure that the research and its methods were relevant to the patient and public needs. Both prepared participant information sheets, coanalysed data, and contributed to study reporting and dissemination through papers, conference presentations and a lay summary.

A novel blood based triage test for colorectal cancer in primary care: a pilot study.

BACKGROUND: The majority of colorectal cancers (CRCs) are detected after symptomatic presentation to primary care. Given the shared symptoms of CRC and benign disorders, it is challenging to manage the risk of missed diagnosis. Colonoscopy resources cannot keep pace with increasing demand. There is a pressing need for access to simple triage tools in primary care to help prioritise patients for referral. AIM: To evaluate the performance of a novel spectroscopy-based CRC blood test in primary care. DESIGN & SETTING: Mixed-methods pilot study of test performance and GP focus group discussions in South Wales. METHOD: Patients on the urgent suspected cancer (USC) pathway were recruited for the Raman spectroscopy (RS) test coupled to machine learning classification ('Raman-CRC') to identify CRC within the referred population. Qualitative focus group work evaluated the acceptability of the test in primary care by thematic analysis of focus group theorising. RESULTS: A total of 532 patients aged ≥50 years referred on the USC pathway were recruited from 27 GP practices. Twenty-nine patients (5.0%) were diagnosed with CRC. Raman-CRC identified CRC with sensitivity 95.7%, specificity 69.3% with area under curve (AUC) of 0.80 compared with colonoscopy as the reference test (248 patients). Stage I and II cancers were detected with 78.6% sensitivity. Focus group themes underlined the convenience of a blood test for the patient and the test's value as a risk assessment tool in primary care. CONCLUSION: The findings support this novel, non-invasive, blood-based method to prioritise those patients most likely to have CRC. Raman-CRC may accelerate access to diagnosis with potential to improve cancer outcomes.

Patient-Reported Experiences and Satisfaction with Rural Outreach Clinics in New South Wales, Australia: A Cross-Sectional Study.

Introduction: Many studies have been conducted on how physicians view outreach health services, yet few have explored how rural patients view these services. This study aimed to examine the patient experience and satisfaction with outreach health services in rural NSW, Australia and the factors associated with satisfaction. Methods: A cross-sectional study was conducted among patients who visited outreach health services between December 2020 and February 2021 across rural and remote New South Wales, Australia. Data on patient satisfaction were collected using a validated questionnaire. Both bivariate (chi-squared test) and multivariate analyses (logistic regression) were performed to identify the factors associated with the outcome variable (patient satisfaction). Results: A total of 207 participants were included in the study. The mean age of respondents was 58.6 years, and 50.2% were men. Ninety-three percent of all participants were satisfied with the outreach health services. Respectful behaviours of the outreach healthcare practitioners were significantly associated with the higher patient satisfaction attending outreach clinics. Conclusions: The current study demonstrated a high level of patient satisfaction regarding outreach health services in rural and remote NSW, Australia. Further, our study findings showed the importance of collecting data about patient satisfaction to strengthen outreach service quality.

Views of Care at End of Life: A Secondary Analysis of Online Feedback Using Care Opinion.

Although there are studies on the use of social media and palliative and end-of-life care (PEOLC), there are no studies specifically investigating the content of online public feedback about PEOLC services. This study sought to understand experiences of end-of-life care provided in hospitals in the West of Scotland by exploring the main themes within the content of stories posted on a nationally endorsed nonprofit feedback online platform, Care Opinion, within a 2-year period. We used "Appreciative Inquiry" as a theoretical framework for this study to determine what works well in end-of-life care, while also identifying areas for further improvement. Of the 1428 stories published on "Care Opinion" from March 2019 to 2021 regarding hospitals in the West of Scotland, 48 (3.36%) were related to end-of-life care, of which all were included in data analysis. Using the software package NVivo and thematic analysis, we identified 4 key themes. We found that people overwhelmingly posted positive feedback about their experiences with end-of-life care. People reported positively about staff professionalism in providing compassionate and person-centered care to meet their loved ones needs at end of life. Other experiences of care related to challenges facing healthcare services, particularly during the COVID-19 pandemic. Quality appraisal of staff responses highlighted areas for improving feedback. This study can add to the aim of improving staff response to people's concerns about end-of-life care. This study has provided a novel perspective of patients' experiences of end-of-life care in hospitals in the West of Scotland. Novel insights were the appreciation of quality of care, staff professionalism, effective communication, and meeting patient's needs at end-of-life particularly by nursing staff.

Sunproofed study protocol: A mixed-methods scoping study of sun safety policies in primary schools in Wales.

BACKGROUND: Skin cancer, including melanoma and non-melanoma (keratinocyte), is increasing in incidence in the UK. Accounting for half of all cancers in England and Wales, the disease significantly impacts overstretched dermatology services. Research suggests that 86% of melanoma is preventable with modified sun exposure. Educating children about sun safety in schools can help prevent skin cancer and is recommended by major health organisations. In England, teaching sun safety in primary schools is compulsory, while in Wales this is left to school discretion. AIMS: Understand how primary schools in Wales are responding to growing skin cancer rates and explore the effectiveness of sun safety policies in schools on knowledge and behaviour. METHODS: Sunproofed is a mixed-methods scoping study comprising 5 work packages (WP) using survey and routine electronic health record (EHR) data supplemented by qualitative case studies. Objective(s) are to: WP1: Discover if primary schools in Wales have sun safety policies; policy characteristics; determine factors that may influence their presence and identify areas where schools need support. WP2: Determine what EHR data is available regarding the incidence of sunburn in primary school children and the feasibility of using this data to evaluate the impact of sun safety policies. WP3: Understand the impact of sun safety policies on sun-safe knowledge and behaviour amongst children, parents, teachers, and school management; identify barriers and facilitators to schools implementing sun safety policies. WP4: Co-produce guidance regarding sun safety policies and best methods for implementation in schools. WP5: Disseminate guidance and findings widely to ensure impact and uptake. DISCUSSION: Skin cancer rates are increasing in the UK, straining limited resources. Sunproofed has the potential to inform the development of future prevention activities, both in Wales and beyond. This could reduce the number of skin cancer cases in the future and keep people healthier for longer.

Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial).

INTRODUCTION: Chronic pain and disability are now well-recognised long-term complications of blunt chest wall trauma. Limited research exists regarding therapeutic interventions that can be used to address these complications. A recent feasibility study was completed testing the methods of a definitive trial. This protocol describes the proposed definitive trial, the aim of which is to investigate the impact of an early exercise programme on chronic pain and disability in patients with blunt chest wall trauma. METHODS/ANALYSIS: This mixed-methods, multicentre, parallel randomised controlled trial will run in four hospitals in Wales and one in England over 12-month recruitment period. Patients will be randomised to either the control group (routine physiotherapy input) or the intervention group (routine physiotherapy input plus a simple exercise programme completed individually by the patient). Baseline measurements including completion of two surveys (Brief Pain Inventory and EuroQol 5-dimensions, 5-Levels) will be obtained on initial assessment. These measures and a client services receipt inventory will be repeated at 3-month postinjury. Analysis of outcomes will focus on rate and severity of chronic pain and disability, cost-effectiveness and acceptability of the programme by patients and clinicians. Qualitative feedback regarding acceptability will be obtained through patient and clinician focus groups. ETHICS/DISSEMINATION: London Riverside Research Ethics Committee (Reference number: 21/LO/0782) and the Health Research Authority granted approval for the trial in December 2021. Patient recruitment will commence in February 2022. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings. TRIAL REGISTRATION NUMBER: ISRCTN65829737; Pre-results.

A survey of current practice in UK emergency department management of patients with blunt chest wall trauma not requiring admission to hospital.

INTRODUCTION: There is no universal agreement or supporting evidence for the content or format of a standardised guidance document for patients with blunt chest wall trauma. The aim of this study is to investigate current UK Emergency Medicine practice of the management of patients with blunt chest wall trauma, who do not require admission to hospital. METHODS: This was a cross-sectional survey study, with mixed quantitative / qualitative analysis methods. A convenience sample of all professions working in the Emergency Departments / Urgent Care Centres in the UK was used. A combination of closed and open-ended questions were included, covering demographics and current practice in the respondent's main place of work. Themes explored included management strategies for safe discharge home, risk prediction and variables considered relevant for inclusion in patient guidance. RESULTS: A total of 113 clinicians responded from all UK trauma networks, including all devolved nations. A total of 20 different risk prediction tools / pathways were reported to be used when assessing whether a patient is safe for discharge home, with over 35 different variables listed by respondents as being important to highlight to patients. Qualitative analysis revealed that a small number of respondents believe patients can be better managed through the improvement of the following; identification of the high-risk patient, initial assessment and current management strategies used in the ED / UCC. DISCUSSION: The wide variation in practice highlighted in this study may be due in part to a lack of national consensus guidelines on how to manage this complex patient group. Further research is needed into whether structured national guidelines for the assessment and management of such patients could potentially lead to an overall improvement in outcomes. Such guidelines should be developed by not only expert clinicians and researchers, but also and more importantly by those service-users who have lived experience of blunt chest wall trauma.

EarLy Exercise in blunt Chest wall Trauma: a feasibility trial (ELECT Trial).

BACKGROUND: The aim was to complete a feasibility study that would test the methods of the main trial, that will investigate whether early thoracic and shoulder girdle exercises reduce chronic pain in patients with blunt chest wall trauma, when compared with normal care. METHODS: A single centre, parallel, feasibility randomised controlled trial was completed at a University Teaching Hospital in Wales between June and September 2019. Adult patients with blunt chest wall trauma, admitted to hospital for greater than 24 hours, with no concurrent, immediately life-threatening injuries, were included. The intervention was a simple physiotherapy programme comprising thoracic and shoulder girdle exercises. Feasibility outcome measures included: primary outcomes: (1) 80% or more of identified eligible patients were approached for potential recruitment to the trial (2) 30% or less of approached, eligible patients dissented to participate in the trial; secondary outcomes: (3) follow-up data for patient secondary outcomes can be collected for 80% or more of patients, (4) there should be no greater than 10% increase in serious adverse events in the intervention group compared with the control group. RESULTS: A total of 19/19 (100%) patients were deemed eligible for the trial and were approached for participation, 5/19 (26%) eligible patients declined to participate in the trial, follow-up data were collected for n=10/14 (71%) patients and there were no serious adverse events reported in either group. CONCLUSIONS: We have demonstrated that a fully powered randomised clinical trial of the EarLy Exercise in blunt Chest wall Trauma Trial is feasible. TRIAL REGISTRATION NUMBER: ISRCTN16197429.

Prognostic prediction tools and clinician communication: a qualitative study of the effect of the STUMBL tool on clinical practice.

BACKGROUND: In recent years, researchers and clinicians have been developing prognostic prediction tools (PPTs) as a way of identifying patients at risk of deterioration. The use of PPTs in the clinical environment not only impacts the risk of adverse outcomes for patients, but the use of these tools also effect clinical practice. Much attention has been paid to the clinical performance of PPTs. But more insight is needed on how the use of PPTs impacts clinical practice. The objective of this study was to map some of the ways in which PPTs effect clinical practice. The STUMBL (STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients) feasibility trial evaluated the use of a new prognostic prediction tool (PPT) to guide the management blunt chest wall trauma patients in the emergency departments (ED). The trial was undertaken between October 2016 and September 2018 and conducted at four sites in England and Wales. Nested within the feasibility trial was a qualitative study aimed at understanding how ED clinicians experienced and used the PPT. The qualitative methods included a focus group and telephone interviews with 9 ED clinicians. This study focused on participant perceptions of the feasibility and use of the STUMBL tool on clinical practice in the ED. RESULTS: Clinical practice is reshaped as a result of the introduction of the STUMBL PPT into the clinical environment. The PPT enhanced reflexive awareness of prognostic practice; facilitated communication between patients and professionals; helps to guide patient outcomes; and provides a common ground for clinician discussion on prognostication. CONCLUSIONS: The qualitative data collected offered useful insights into the ways in which the tool changes clinical practice. This was a small study of the effect of one kind of PPT on clinical practice. Nevertheless, this study maps areas in which clinical practice is affected by the introduction of a PPT into the clinical environment. More research is needed to better understand these effects, and to understand how these tools become embedded in clinical practice over the longer term.

A multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL Trial.

OBJECTIVE: A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). The aim of this trial is to assess the feasibility and acceptability of a definitive impact trial investigating the clinical and cost-effectiveness of a new prognostic model for the management of patients with blunt chest wall trauma in the ED. DESIGN: Stepped wedge feasibility trial. SETTING: Four EDs in England and Wales. PARTICIPANTS: Adult blunt chest wall trauma patients presenting to the ED with no concurrent, life-threatening injuries. INTERVENTION: A prognostic model (the STUMBL score) to guide clinical decision-making. OUTCOME MEASURES: Primary: participant recruitment rate and clinicians' use of the STUMBL score. Secondary: composite outcome measure (mortality, pulmonary complications, delayed upgrade in care, unplanned representations to the ED), physical and mental components of quality of life, clinician feedback and health economic data gathering methodology for healthcare resource utilisation. RESULTS: Quantitative data were analysed using the intention-to-treat principle. 176 patients were recruited; recruitment targets were achieved at all sites. Clinicians used the model in 96% of intervention cases. All feasibility criteria were fully or partially met. After adjusting for predefined covariates, there were no statistically significant differences between the control and intervention periods. Qualitative analysis highlighted that STUMBL was well-received and clinicians would support a definitive trial. Collecting data on intervention costs, health-related quality of life and healthcare resource use was feasible. DISCUSSION: We have demonstrated that a fully powered randomised clinical trial of the STUMBL score is feasible and desirable to clinicians. Minor methodological modifications will be made for the full trial. TRIAL REGISTRATION NUMBER: ISRCTN95571506; Post-results.

"How Long Have I Got?"-A Prospective Cohort Study Comparing Validated Prognostic Factors for Use in Patients with Advanced Cancer.

BACKGROUND: The optimal prognostic factors in patients with advanced cancer are not known, as a comparison of these is lacking. The aim of the present study was to determine the optimal prognostic factors by comparing validated factors. MATERIALS AND METHODS: A multicenter, prospective observational cohort study recruited patients over 18 years with advanced cancer. The following were assessed: clinician-predicted survival (CPS), Eastern Cooperative Oncology Group performance status (ECOG-PS), patient reported outcome measures (anorexia, cognitive impairment, dyspnea, global health), metastatic disease, weight loss, modified Glasgow Prognostic Score (mGPS) based on C-reactive protein and albumin, lactate dehydrogenase (LDH), and white (WCC), neutrophil (NC), and lymphocyte cell counts. Survival at 1 and 3 months was assessed using area under the receiver operating curve and logistic regression analysis. RESULTS: Data were available on 478 patients, and the median survival was 4.27 (1.86-7.03) months. On univariate analysis, the following factors predicted death at 1 and 3 months: CPS, ECOG-PS, mGPS, WCC, NC (all p < .001), dyspnea, global health (both p ≤ .001), cognitive impairment, anorexia, LDH (all p < .01), and weight loss (p < .05). On multivariate analysis ECOG-PS, mGPS, and NC were independent predictors of survival at 1 and 3 months (all p < .01). CONCLUSION: The simple combination of ECOG-PS and mGPS is an important novel prognostic framework which can alert clinicians to patients with good performance status who are at increased risk of having a higher symptom burden and dying at 3 months. From the recent literature it is likely that this framework will also be useful in referral for early palliative care with 6-24 months survival. IMPLICATIONS FOR PRACTICE: This large cohort study examined all validated prognostic factors in a head-to-head comparison and demonstrated the superior prognostic value of the Eastern Cooperative Oncology Group performance status (ECOG-PS)/modified Glasgow Prognostic Score (mGPS) combination over other prognostic factors. This combination is simple, accurate, and also relates to quality of life. It may be useful in identifying patients who may benefit from early referral to palliative care. It is proposed ECOG-PS/mGPS as the new prognostic domain in patients with advanced cancer.

Forty years of IVF.

This monograph, written by the pioneers of IVF and reproductive medicine, celebrates the history, achievements, and medical advancements made over the last 40 years in this rapidly growing field.

Physiotherapy and Anterior Resection Syndrome (PARiS) trial: feasibility study protocol.

INTRODUCTION: Rectal cancer affects more than 600 patients per year in Wales, with a 5-year survival rate of around 60%. A recent report demonstrated that 19% of patients with bowel cancer had difficulty controlling their bowels after surgery, and these patients were twice as likely to report lower quality of life than those who had control. Nearly all patients will experience bowel dysfunction initially following surgery and up to 25% will experience severe bowel dysfunction on a long-term basis. The aim of this study is to test the feasibility of introducing a simple intervention in an attempt to improve bowel function following surgery for rectal cancer. We propose the introduction of an educational session from specialist nurses and physiotherapists prior to surgery and a subsequent physiotherapy programme for 3 months to teach patients how to strengthen their pelvic floor. METHODS AND ANALYSIS: All patients with rectal cancer planned to receive an anterior resection will be approached for the study. The study will take place in three centres over 12 months, and we expect to recruit 40 patients. The primary outcome measure is the proportion of eligible patients approached who consent to and attend the educational session. The secondary outcomes include patient compliance to the pelvic floor rehabilitation programme (assessed by patient paper or electronic diary), the acceptability of the intervention to the patient (assessed using qualitative interviews) and preoperative and postoperative pelvic floor tone (assessed using the Oxford Grading System and the International Continence Society Grading System), patient bowel function and patient quality of life (assessed using validated questionnaires). ETHICS AND DISSEMINATION: Ethics approval was granted. This feasibility study is in progress. If patients find the intervention acceptable, the next stage would be a trial comparing outcomes after anterior resection in those who have and do not have physiotherapy. TRIAL REGISTRATION NUMBER: ISRCTN77383505; Pre-results.

Blastocyst development rate influences implantation and live birth rates of similarly graded euploid blastocysts.

OBJECTIVE: To determine whether the blastocyst development rate, as assessed by the day of trophectoderm biopsy (day 5 vs. day 6), affects the live birth rate (LBR) of similarly graded euploid blastocysts. DESIGN: Retrospective cohort study. SETTING: Academic medical center. PATIENT(S): Patients who underwent frozen-thawed single euploid blastocyst transfers from 2013 to 2016 were included. Blastocyst morphologic grading was performed on day 5 or day 6 before the biopsy, with embryos designated into the following groups: good (3-6AA, 3-6AB, and 3-6BA), average (2-6BB), and poor (2-6BC and 2-6CB). INTERVENTION(S): Frozen-thawed embryo transfer. MAIN OUTCOME MEASURE(S): Implantation rate (IR) and LBR. RESULT(S): A total of 701 frozen-thawed single euploid blastocyst transfer cycles were included. Cycles in which day 5 blastocysts were transferred (n = 366) were associated with a significantly higher LBR than those in which day 6 blastocysts were transferred (n = 335; 60.4% vs. 44.8%). The odds ratio remained significant after controlling for all confounders, including the blastocyst grading. Furthermore, there was a significant difference in LBRs between good-quality, average-quality, and poor-quality blastocysts (67.8%, 53.4%, and 29.5%, respectively). Embryos reaching good-quality blastocysts on day 5 yielded significantly higher LBR (72.8% vs. 56.5%) and IR (77.7% vs. 58.7%) compared with those reaching similar quality blastocysts on day 6. Similarly, day 5 average-quality embryos conveyed a significantly higher IR compared with day 6 embryos of the same quality (64.4% vs. 53.4%). CONCLUSION(S): In addition to aneuploidy assessment, the speed of embryo development to the blastocyst stage and an evaluation of blastocyst morphology are critical to selecting the best embryo.

Histone variant H3.3-mediated chromatin remodeling is essential for paternal genome activation in mouse preimplantation embryos.

Derepression of chromatin-mediated transcriptional repression of paternal and maternal genomes is considered the first major step that initiates zygotic gene expression after fertilization. The histone variant H3.3 is present in both male and female gametes and is thought to be important for remodeling the paternal and maternal genomes for activation during both fertilization and embryogenesis. However, the underlying mechanisms remain poorly understood. Using our H3.3B-HA-tagged mouse model, engineered to report H3.3 expression in live animals and to distinguish different sources of H3.3 protein in embryos, we show here that sperm-derived H3.3 (sH3.3) protein is removed from the sperm genome shortly after fertilization and extruded from the zygotes via the second polar bodies (PBII) during embryogenesis. We also found that the maternal H3.3 (mH3.3) protein is incorporated into the paternal genome as early as 2 h postfertilization and is detectable in the paternal genome until the morula stage. Knockdown of maternal H3.3 resulted in compromised embryonic development both of fertilized embryos and of androgenetic haploid embryos. Furthermore, we report that mH3.3 depletion in oocytes impairs both activation of the Oct4 pluripotency marker gene and global de novo transcription from the paternal genome important for early embryonic development. Our results suggest that H3.3-mediated paternal chromatin remodeling is essential for the development of preimplantation embryos and the activation of the paternal genome during embryogenesis.

The safety of intracytoplasmic sperm injection and long-term outcomes.

The pioneering of intracytoplasmic sperm injection (ICSI) approximately 25 years ago revolutionized the treatment of infertile couples. Today, ICSI remains an indispensable part of assisted reproductive treatments (ART) and has resulted in the birth of millions of babies. The 25th anniversary of ICSI marks a chronologic landmark in its evolving history. This landmark also serves as an opportunity to thoroughly appraise the safety of ICSI and analyze the long-term outcomes of ICSI-conceived children. In this review, we collate and analyze salient data accrued over the past 25 years pertaining to the long-term safety of ICSI and ICSI conceptions. We also evaluate the effects of ICSI on the perinatal outcomes, congenital malformation rates, cognitive development and reproductive health of ICSI-conceived neonates, children, adolescents and adults, respectively. In doing so, we also highlight the existence of potential confounders and biases that frequently obscure the interpretation of clinical follow-up studies.

Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial.

INTRODUCTION: A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). A definitive randomised controlled trial (impact trial) is required to assess the clinical and cost effectiveness of the new model before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. METHODS/ANALYSIS: This feasibility trial is designed to test the methods of a multicentre, cluster-randomised (stepped- wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a 5-month period; in the initial period acting as the controls (normal care), and in the second period acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a 6-week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory). Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. ETHICS AND DISSEMINATION: Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Patient recruitment will commence in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings. TRIAL REGISTRATION NUMBER: ISRCTN95571506; Pre-results.