Introducing WASHOUT: A Large-scale Observational Study of Inpatient Haematuria.

WASHOUT is an international, multicentre, prospective observational study aiming to describe the management of unscheduled haematuria admissions. Preregistration can be done using the following link: https://redcap.link/WASHOUT.

A systematic review and network meta-analysis of outcomes after total wrist arthroplasty in inflammatory and non-inflammatory arthritis.

This systematic review analysed the available evidence on the clinical outcomes of total wrist arthroplasty (TWA) in patients with inflammatory and non-inflammatory arthritis. After screening, 12 studies met the inclusion criteria. They involved 359 patients with 378 TWA implants. The results showed that TWA significantly improved Disabilities of the Arm, Shoulder and Hand (DASH)/Quick-DASH scores and pain visual analogue scale scores in both arthritis groups compared with preoperative values. However, there was no statistically significant difference in the outcome scores between the two groups. Three studies reported Patient-Rated Wrist Evaluation (PRWE) scores, and TWA significantly improved PRWE scores in non-inflammatory arthritis but not in inflammatory arthritis, with no significant difference in postoperative outcome scores between the two groups. Although the included studies have limitations, the review suggests that TWA may be a successful treatment for wrist pain in individuals with either inflammatory or non-inflammatory arthritis. However, further high-quality trials are needed to confirm these findings.

How to support others in developing a career in clinical education research.

The Incubator for Clinical Education Research (ClinEdR) is a UK-wide network, established with support from the National Institute for Health Research, to lead initiatives to build capacity in the field. A key barrier identified by this group is that many experienced educators, clinicians, and researchers, who may be committed to supporting others, have little guidance on how best to do this. In this "How to …" paper, we draw on relevant literature and our individual and collective experiences as members of the National Institute for Health Research ClinEdR incubator to offer suggestions on how educators can support others to develop successful careers involving ClinEdR. This article offers guidance and inspiration for all professionals whose role involves research and scholarship and who encounter aspiring or developing clinical education researchers in the course of their work. It will also be of interest to researchers who are starting out and progressing in the field.

Global Variation in Magnetic Resonance Imaging Quality of the Prostate.

Background High variability in prostate MRI quality might reduce accuracy in prostate cancer detection. Purpose To prospectively evaluate the quality of MRI scanners taking part in the quality control phase of the global PRIME (Prostate Imaging Using MRI ± Contrast Enhancement) trial using the Prostate Imaging Quality (PI-QUAL) standardized scoring system, give recommendations on how to improve the MRI protocols, and establish whether MRI quality could be improved by these recommendations. Materials and Methods In the prospective clinical trial (PRIME), for each scanner, centers performing prostate MRI submitted five consecutive studies and the MRI protocols (phase I). Submitted data were evaluated in consensus by two expert genitourinary radiologists using the PI-QUAL scoring system that evaluates MRI diagnostic quality using five points (1 and 2 = nondiagnostic; 3 = sufficient; 4 = adequate, 5 = optimal) between September 2021 and August 2022. Feedback was provided for scanners not achieving a PI-QUAL 5 score, and centers were invited to resubmit new imaging data using the modified protocol (phase II). Descriptive comparison of outcomes was made between the MRI scanners, feedback provided, and overall PI-QUAL scores. Results In phase I, 41 centers from 18 countries submitted a total of 355 multiparametric MRI studies from 71 scanners, with nine (13%) scanners achieving a PI-QUAL score of 3, 39 (55%) achieving a score of 4, and 23 (32%) achieving a score of 5. Of the 48 (n = 71 [68%]) scanners that received feedback to improve, the dynamic contrast-enhanced sequences were those that least adhered to the Prostate Imaging Reporting and Data System, version 2.1, criteria (44 of 48 [92%]), followed by diffusion-weighted imaging (20 of 48 [42%]) and T2-weighted imaging (19 of 48 [40%]). In phase II, 36 centers from 17 countries resubmitted revised studies, resulting in a total of 62 (n = 64 [97%]) scanners with a final PI-QUAL score of 5. Conclusion Substantial variation in global prostate MRI acquisition parameters as a measure of quality was observed, particularly with DCE sequences. Basic evaluation and modifications to MRI protocols using PI-QUAL can lead to substantial improvements in quality. Clinical trial registration no. NCT04571840 Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Almansour and Chernyak in this issue.

How to navigate entry into the field of clinical education research and scholarship.

Clinical education research (ClinEdR) is a growing field that aims to ensure the way healthcare professionals are taught and learn is evidence-based. There is growing interest in how this evidence is generated in a robust, timely and cost-effective fashion. In this 'How to …' paper, we draw on relevant literature and our own experiences to offer suggestions on how novice researchers can navigate entry into the field of ClinEdR. We summarise key resources for those at the earliest stages of their interest in ClinEdR and scholarship and provide personal experiences of networking, collaborating and balancing research with a clinical or teaching role. This paper will be of interest to those at any stage in their clinical career with little to no experience of ClinEdR, but the enthusiasm to get started.

The ARTS (Avoiding Risks of Thrombosis and Bleeding in Surgery) Trial: Lessons Learnt in Setting Up an International Multicentre Clinical Trial of an Investigational Medicinal Product in the UK.

We describe our experience in setting up the UK arm of the ARTS trial and highlight regulatory and funding challenges in relation to an international multicentre setting for an investigational medicinal product.

A Rare Case of Exostosis of the Medial Sesamoid Bone.

Introduction: Exostoses in the foot and ankle are extremely rare with no current literature of exostosis of the sesamoid bone. Case Report: A middle-aged woman was referred to orthopedic foot surgeons following a long-standing issue of a painful non-fluctuant swelling beneath her left hallux with normal imaging. Repeat X-rays, with sesamoid views of the foot, were conducted due to the patient's ongoing symptoms. The patient underwent a surgical excision and made a complete recovery. The patient is now able to comfortably walk for longer distances with no restrictions to her mobility. Conclusion: Conservative management should be initially trialed to preserve the foot's functions and limit the risk of surgical complications. As in this case, when surgical options are explored, it is critical to preserve as much of the sesamoid bone as possible to restore and sustain function.

How to define clinical education research terminology: A glossary.

Clinical education research (ClinEdR) utilises diverse terminology, which can lead to confusion. A common language is essential for enhancing impact. An expert panel drawn from various workstreams within the National Institute for Health and Care Research (NIHR) Incubator for Clinical Education Research was tasked with reviewing an initial list of terms for the development of a glossary of terms in the field of ClinEdR. The glossary was populated with terms, definitions and foundational papers by the authors and peer-reviewed for accuracy. The glossary of terms developed for ClinEdR should enable researchers to use a common language, promoting consistency and improving communication. We anticipate this will be useful for ClinEdR students and early career researchers. The glossary could be integrated into educational research methods courses in ClinEdR, and through critical and reflective use, enhance the quality and subsequent impact of ClinEdR.

Audit, Feedback, and Education to Improve Quality and Outcomes in Transurethral Resection and Single-Instillation Intravesical Chemotherapy for Nonmuscle Invasive Bladder Cancer Treatment: Protocol for a Multicenter International Observational Study With an Embedded Cluster Randomized Trial.

BACKGROUND: Nonmuscle invasive bladder cancer (NMIBC) accounts for 75% of bladder cancers. It is common and costly. Cost and detriment to patient outcomes and quality of life are driven by high recurrence rates and the need for regular invasive surveillance and repeat treatments. There is evidence that the quality of the initial surgical procedure (transurethral resection of bladder tumor [TURBT]) and administration of postoperative bladder chemotherapy significantly reduce cancer recurrence rates and improve outcomes (cancer progression and mortality). There is surgeon-reported evidence that TURBT practice varies significantly across surgeons and sites. There is limited evidence from clinical trials of intravesical chemotherapy that NMIBC recurrence rate varies significantly between sites and that this cannot be accounted for by differences in patient, tumor, or adjuvant treatment factors, suggesting that how the surgery is performed may be a reason for the variation. OBJECTIVE: This study primarily aims to determine if feedback on and education about surgical quality indicators can improve performance and secondarily if this can reduce cancer recurrence rates. Planned secondary analyses aim to determine what surgeon, operative, perioperative, institutional, and patient factors are associated with better achievement of TURBT quality indicators and NMIBC recurrence rates. METHODS: This is an observational, international, multicenter study with an embedded cluster randomized trial of audit, feedback, and education. Sites will be included if they perform TURBT for NMIBC. The study has four phases: (1) site registration and usual practice survey; (2) retrospective audit; (3) randomization to audit, feedback, and education intervention or to no intervention; and (4) prospective audit. Local and national ethical and institutional approvals or exemptions will be obtained at each participating site. RESULTS: The study has 4 coprimary outcomes, which are 4 evidence-based TURBT quality indicators: a surgical performance factor (detrusor muscle resection); an adjuvant treatment factor (intravesical chemotherapy administration); and 2 documentation factors (resection completeness and tumor features). A key secondary outcome is the early cancer recurrence rate. The intervention is a web-based surgical performance feedback dashboard with educational and practical resources for TURBT quality improvement. It will include anonymous site and surgeon-level peer comparison, a performance summary, and targets. The coprimary outcomes will be analyzed at the site level while recurrence rate will be analyzed at the patient level. The study was funded in October 2020 and began data collection in April 2021. As of January 2023, there were 220 hospitals participating and over 15,000 patient records. Projected data collection end date is June 30, 2023. CONCLUSIONS: This study aims to use a distributed collaborative model to deliver a site-level web-based performance feedback intervention to improve the quality of endoscopic bladder cancer surgery. The study is funded and projects to complete data collection in June 2023. TRIAL REGISTRATION: ClinicalTrials.org NCT05154084; https://clinicaltrials.gov/ct2/show/NCT05154084. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42254.

Comparing biparametric to multiparametric MRI in the diagnosis of clinically significant prostate cancer in biopsy-naive men (PRIME): a prospective, international, multicentre, non-inferiority within-patient, diagnostic yield trial protocol.

INTRODUCTION: Prostate MRI is a well-established tool for the diagnostic work-up for men with suspected prostate cancer (PCa). Current recommendations advocate the use of multiparametric MRI (mpMRI), which is composed of three sequences: T2-weighted sequence (T2W), diffusion-weighted sequence (DWI) and dynamic contrast-enhanced sequence (DCE). Prior studies suggest that a biparametric MRI (bpMRI) approach, omitting the DCE sequences, may not compromise clinically significant cancer detection, though there are limitations to these studies, and it is not known how this may affect treatment eligibility. A bpMRI approach will reduce scanning time, may be more cost-effective and, at a population level, will allow more men to gain access to an MRI than an mpMRI approach. METHODS: Prostate Imaging Using MRI±Contrast Enhancement (PRIME) is a prospective, international, multicentre, within-patient diagnostic yield trial assessing whether bpMRI is non-inferior to mpMRI in the diagnosis of clinically significant PCa. Patients will undergo the full mpMRI scan. Radiologists will be blinded to the DCE and will initially report the MRI using only the bpMRI (T2W and DWI) sequences. They will then be unblinded to the DCE sequence and will then re-report the MRI using the mpMRI sequences (T2W, DWI and DCE). Men with suspicious lesions on either bpMRI or mpMRI will undergo prostate biopsy. The main inclusion criteria are men with suspected PCa, with a serum PSA of ≤20 ng/mL and without prior prostate biopsy. The primary outcome is the proportion of men with clinically significant PCa detected (Gleason score ≥3+4 or Gleason grade group ≥2). A sample size of at least 500 patients is required. Key secondary outcomes include the proportion of clinically insignificant PCa detected and treatment decision. ETHICS AND DISSEMINATION: Ethical approval was obtained from the National Research Ethics Committee West Midlands, Nottingham (21/WM/0091). Results of this trial will be disseminated through peer-reviewed publications. Participants and relevant patient support groups will be informed about the results of the trial. TRIAL REGISTRATION NUMBER: NCT04571840.

Ethnic differences in cellular and humoral immune responses to SARS-CoV-2 vaccination in UK healthcare workers: a cross-sectional analysis.

Background: Few studies have compared SARS-CoV-2 vaccine immunogenicity by ethnic group. We sought to establish whether cellular and humoral immune responses to SARS-CoV-2 vaccination differ according to ethnicity in UK Healthcare workers (HCWs). Methods: In this cross-sectional analysis, we used baseline data from two immunological cohort studies conducted in HCWs in Leicester, UK. Blood samples were collected between March 3, and September 16, 2021. We excluded HCW who had not received two doses of SARS-CoV-2 vaccine at the time of sampling and those who had serological evidence of previous SARS-CoV-2 infection. Outcome measures were SARS-CoV-2 spike-specific total antibody titre, neutralising antibody titre and ELISpot count. We compared our outcome measures by ethnic group using univariable (t tests and rank-sum tests depending on distribution) and multivariable (linear regression for antibody titres and negative binomial regression for ELISpot counts) tests. Multivariable analyses were adjusted for age, sex, vaccine type, length of interval between vaccine doses and time between vaccine administration and sample collection and expressed as adjusted geometric mean ratios (aGMRs) or adjusted incidence rate ratios (aIRRs). To assess differences in the early immune response to vaccination we also conducted analyses in a subcohort who provided samples between 14 and 50 days after their second dose of vaccine. Findings: The total number of HCWs in each analysis were 401 for anti-spike antibody titres, 345 for neutralising antibody titres and 191 for ELISpot. Overall, 25.4% (19.7% South Asian and 5.7% Black/Mixed/Other) were from ethnic minority groups. In analyses including the whole cohort, neutralising antibody titres were higher in South Asian HCWs than White HCWs (aGMR 1.47, 95% CI [1.06-2.06], P = 0.02) as were T cell responses to SARS-CoV-2 S1 peptides (aIRR 1.75, 95% CI [1.05-2.89], P = 0.03). In a subcohort sampled between 14 and 50 days after second vaccine dose, SARS-CoV-2 spike-specific antibody and neutralising antibody geometric mean titre (GMT) was higher in South Asian HCWs compared to White HCWs (9616 binding antibody units (BAU)/ml, 95% CI [7178-12,852] vs 5888 BAU/ml [5023-6902], P = 0.008 and 2851 95% CI [1811-4487] vs 1199 [984-1462], P < 0.001 respectively), increments which persisted after adjustment (aGMR 1.26, 95% CI [1.01-1.58], P = 0.04 and aGMR 2.01, 95% CI [1.34-3.01], P = 0.001). SARS-CoV-2 ELISpot responses to S1 and whole spike peptides (S1 + S2 response) were higher in HCWs from South Asian ethnic groups than those from White groups (S1: aIRR 2.33, 95% CI [1.09-4.94], P = 0.03; spike: aIRR, 2.04, 95% CI [1.02-4.08]). Interpretation: This study provides evidence that, in an infection naïve cohort, humoral and cellular immune responses to SARS-CoV-2 vaccination are stronger in South Asian HCWs than White HCWs. These differences are most clearly seen in the early period following vaccination. Further research is required to understand the underlying mechanisms, whether differences persist with further exposure to vaccine or virus, and the potential impact on vaccine effectiveness. Funding: DIRECT and BELIEVE have received funding from UK Research and Innovation (UKRI) through the COVID-19 National Core Studies Immunity (NCSi) programme (MC_PC_20060).

The Prognostic Value of Neutrophil-to-Lymphocyte Ratio and Platelet-to-Lymphocyte Ratio for Small Renal Cell Carcinomas after Image-Guided Cryoablation or Radio-Frequency Ablation.

There is a lack of cheap and effective biomarkers for the prediction of renal cancer outcomes post-image-guided ablation. This is a retrospective study of patients with localised small renal cell cancer (T1a or T1b) undergoing cryoablation or radiofrequency ablation (RFA) at our institution from 2003 to 2016. A total of 203 patients were included in the analysis. In the multivariable analysis, patients with raised neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) pre-operatively, post-operatively and peri-operatively are associated with significantly worsened cancer-specific survival, overall survival and metastasis-free survival. Furthermore, an increased PLR pre-operatively is also associated with increased odds of a larger than 25% drop in renal function post-operatively. In conclusion, NLR and PLR are effective prognostic factors in predicting oncological outcomes and peri-operative outcomes; however, larger external datasets should be used to validate the findings prior to clinical application.

Decision Regret in Patients with Localised Prostate Cancer: A Systematic Review and Meta-analysis.

CONTEXT: Treatment choice for localised prostate cancer remains a significant challenge for patients and clinicians, with uncertainty over decisions potentially leading to conflict and regret. There is a need to further understand the prevalence and prognostic factors of decision regret to improve patient quality of life. OBJECTIVE: To generate the best estimates for the prevalence of significant decision regret localised prostate cancer patients, and to investigate prognostic patient, oncological, and treatment factors associated with regret. EVIDENCE ACQUISITION: We performed a systematic search of MEDLINE, Embase, and PsychINFO databases including studies evaluating the prevalence or patient, treatment, or oncological prognostic factors in localised prostate cancer patients. A pooled prevalence of significant regret was calculated with the formal prognostic factor evaluation conducted per factor identified. EVIDENCE SYNTHESIS: Significant decision regret was present in a pooled 20% (95% confidence interval 16-23) of patients across 14 studies and 17883 patients. This was lower in active surveillance (13%), with little difference between those who underwent radiotherapy (19%) and those who underwent prostatectomy (18%). Evaluation of individual prognostic factors demonstrated higher regret in those with poorer post-treatment bowel, sexual, and urinary function; decreased involvement in the decision-making process; and Black ethnicity. However, evidence remains conflicting, with low or moderate certainty of findings. CONCLUSIONS: A significant proportion of men experience decision regret after a localised prostate cancer diagnosis. Monitoring those with increased functional symptoms and improving patient involvement in the decision-making process through education and decision aids may reduce regret. PATIENT SUMMARY: We looked at how common regret in treatment decisions is after treatment for early-stage prostate cancer and factors linked with this. We found that one in five regret their decision, with those who had experienced side effects or were less involved in the decision-making process more likely to have regret. By addressing these, clinicians could reduce regret and improve quality of life.

Clinical support during COVID-19: An opportunity for service and learning? A cross-sectional survey of UK medical students.

PURPOSE: Medical students providing support to clinical teams during Covid-19 may have been an opportunity for service and learning. We aimed to understand why the reported educational impact has been mixed to inform future placements. METHODS: We conducted a cross-sectional survey of medical students at UK medical schools during the first Covid-19 'lockdown' period in the UK (March-July 2020). Analysis was informed by the conceptual framework of service and learning. RESULTS: 1245 medical students from 37 UK medical schools responded. 57% of respondents provided clinical support across a variety of roles and reported benefits including increased preparedness for foundation year one compared to those who did not (p < 0.0001). However, not every individual's experience was equal. For some, roles complemented the curriculum and provided opportunities for clinical skill development, reflection, and meaningful contribution to the health service. For others, the relevance of their role to their education was limited; these roles typically focused on service provision, with few opportunities to develop. CONCLUSION: The conceptual framework of service and learning can help explain why student experiences have been heterogeneous. We highlight how this conceptual framework can be used to inform clinical placements in the future, in particular the risks, benefits, and structures.[Box: see text].

The current status of interventional radiology in the undergraduate medical curriculum and the way forward.

Interventional radiology (IR) is underrepresented in undergraduate medical school curricula. Despite the introduction of a suggested undergraduate curriculum for IR by the British Society of Interventional Radiology (BSIR), current evidence suggests there is inadequate knowledge and awareness of IR amongst medical students. As a result of this, there is a lack of visibility of the subspeciality amongst medical students and junior doctors contributing to the shortage of IR trainees resulting in an IR workforce crisis in the UK. The uptake of the proposed undergraduate IR curriculum remains unclear, highlighting the need for a thorough audit and improvement of IR teaching in undergraduate medical education. In this commentary, we discuss the importance of including IR in the undergraduate curriculum, the evidence surrounding undergraduate IR education, the reasons for the potential lack of interest in IR from medical students and future steps to ensure optimal IR exposure in undergraduate medical school curricula.