Upper gastrointestinal training in the UK and Ireland: a Roux Group Study.

INTRODUCTION: Surgical training programmes in the United Kingdom and Ireland (UK&I) are in a state of flux. This study aims to report the contemporary opinions of trainee and consultant surgeons on the current upper gastrointestinal (UGI) training model in the UK&I. METHODS: A questionnaire was developed and distributed via national UGI societies. Questions pertained to demographics, current training evaluation, perceived requirements and availability. RESULTS: A total of 241 responses were received with representation from all UK&I postgraduate training regions. The biggest discrepancies between rotation demand and national availability related to advanced/therapeutic endoscopy and robotic surgery, with 91.7% of respondents stating they would welcome greater geographical flexibility in training. The median suggested academic targets were 3-5 publications (trainee vs consultant <3 vs 3-5, p<0.001); <3 presentations (<3 vs 3-5, p=0.002); and 3-5 audits/quality improvement projects (<3 vs 3-5, p<0.001). Current operative requirements were considered achievable (87.6%) but inadequate for day one consultant practice (74.7%). Reassuringly, 76.3% deemed there was role for on-the-job operative training following consultant appointment. Proficiency in diagnostic endoscopy was considered a minimum requirement for Certificate of Completion of Training (CCT) yet the majority regarded therapeutic endoscopy competency as non-essential. The median numbers of index UGI operations suggested were comparable with the current curriculum requirements. Post-CCT fellowships were not considered necessary; however, the majority (73.6%) recognised their advantage. CONCLUSIONS: Current CCT requirements are largely consistent with the opinions of the UGI community. Areas for improvement include flexibility in geographical working and increasing national provisions for high-quality endoscopy training.

Development of a Prediction Model for Surgery or Early Mortality at the Time of Initial Assessment for Necrotizing Enterocolitis.

OBJECTIVE: No available scale, at the time of initial evaluation for necrotizing enterocolitis (NEC), accurately predicts, that is, with an area under the curve (AUC) ≥0.9, which preterm infants will undergo surgery for NEC stage III or die within a week. STUDY DESIGN: This is a retrospective cohort study (n = 261) of preterm infants with <33 weeks' gestation or <1,500 g birthweight with either suspected or with definite NEC born at Parkland Hospital between 2009 and 2021. A prediction model using the new HASOFA SCORE (H: yperglycemia, H: yperkalemia, use of inotropes for H: ypotension during the prior week, A: cidemia, Neonatal S: equential O: rgan F: ailure A: ssessment [nSOFA: ] score) was compared with a similar model using the nSOFA score. RESULTS: Among 261 infants, 112 infants had NEC stage I, 68 with NEC stage II, and 81 with NEC stage III based on modified Bell's classification. The primary outcome, surgery for NEC stage III or death within a week, occurred in 81 infants (surgery in 66 infants and death in 38 infants). All infants with pneumoperitoneum or abdominal compartment syndrome either died or had surgery. The HASOFA and the nSOFA scores were evaluated in 254 and 253 infants, respectively, at the time of the initial workup for NEC. Both models were internally validated. The HASOFA model was a better predictor of surgery for NEC stage III or death within a week than the nSOFA model, with greater AUC 0.909 versus 0.825, respectively, p < 0.001. Combining HASOFA at initial assessment with concurrent or later presence of abdominal wall erythema or portal gas improved the prediction surgery for NEC stage III or death with AUC 0.942 or 0.956, respectively. CONCLUSION: Using this new internally validated prediction model, surgery for NEC stage III or death within a week can be accurately predicted at the time of initial assessment for NEC. KEY POINTS: · No available scale, at initial evaluation, accurately predicts which preterm infants will undergo surgery for NEC stage III or die within a week.. · In this retrospective cohort study of 261 preterm infants with either suspected or definite NEC we developed a new prediction model (HASOFA score).. · The HASOFA-model had high discrimination (AUC 0.909) and excellent calibration and was internally validated..

The STAMPEDE2 Trial: a Site Survey of Current Patterns of Care, Access to Imaging and Treatment of Metastatic Prostate Cancer.

AIMS: The forthcoming STAMPEDE2 trial has three comparisons in metastatic hormone-sensitive prostate cancer. We aim to determine clinical practices among STAMPEDE trial investigators for access to imaging and therapeutic choices and explore their interest in participation in STAMPEDE2. MATERIALS AND METHODS: The survey was developed and distributed online to 120 UK STAMPEDE trial sites. Recipients were invited to complete the survey between 16 and 30 May 2022. The survey consisted of 30 questions in five sections on access to stereotactic ablative body radiotherapy (SABR), 177lutetium-prostate-specific membrane antigen-617 (177Lu-PSMA-617), choice of systemic therapies and use of positron emission tomography/computerised tomography and whole-body magnetic resonance imaging. RESULTS: From 58/120 (48%) sites, 64 respondents completed the survey: 55/64 (86%) respondents were interested to participate in SABR, 44/64 (69%) in 177Lu-PSMA-617 and 56/64 (87.5%) in niraparib with abiraterone comparisons; 45/64 (70%) respondents had access to bone, spine and lymph node metastases SABR delivery and 7/64 (11%) to 177Lu-PSMA-617. In addition to androgen deprivation therapy, 60/64 (94%) respondents used androgen receptor signalling inhibitors and 46/64 (72%) used docetaxel; 29/64 (45%) respondents would consider triplet therapy with androgen deprivation therapy, androgen receptor signalling inhibitors and docetaxel. Positron emission tomography/computerised tomography was available to 62/64 (97%) respondents and requested by 45/64 (70%) respondents for disease uncertainty on conventional imaging and 39/64 (61%) at disease relapse. Whole-body magnetic resonance imaging was available to 24/64 (38%) respondents and requested by 13/64 (20%) respondents in highly selected patients. In low-volume disease, 38/64 (59%) respondents requested scans at baseline and disease relapse. In high-volume disease, 29/64 (45%) respondents requested scans at baseline, best response (at prostate-specific antigen nadir) and disease relapse; 54/64 (84%) respondents requested computerised tomography and bone scan for best response assessment. CONCLUSION: There is noteworthy disparity in clinical practice across current study sites, however most have expressed an interest in participation in the forthcoming STAMPEDE2 trial.

Biocompatibility of Antifogging SiO-doped Diamond-Like Carbon Laparoscope Coatings.

Laparoscopes can suffer from fogging and contamination difficulties, resulting in a reduced field of view during surgery. A series of diamond-like carbon films, doped with SiO, were produced by pulsed laser deposition for evaluation as biocompatible, antifogging coatings. DLC films doped with SiO demonstrated hydrophilic properties with water contact angles under 40°. Samples subjected to plasma cleaning had improved contact angle results, with values under 5°. Doping the DLC films with SiO led to an average 40% decrease in modulus and 60% decrease in hardness. Hardness of the doped films, 12.0 - 13.2 GPa, was greater than that of the uncoated fused silica substrate, 9.2 GPa. The biocompatibility was assessed through CellTiter-Glo assays, with the films demonstrating statistically similar levels of cell viability when compared to the control media. The absence of ATP released by blood platelets in contact with the DLC coatings suggests in vivo hemocompatibility. The SiO doped films displayed improved transparency levels in comparison to undoped films, achieving up to an average of 80% transmission over the visible spectrum and an attenuation coefficient of 1.1 × 104 cm-1 at the 450 nm wavelength. The SiO doped DLC films show promise as a method of fog prevention for laparoscopes.

Plasma and rectal mucosal oxylipin levels during aspirin and eicosapentaenoic acid treatment in the seAFOod polyp prevention trial.

BACKGROUND: Aspirin and eicosapentaenoic acid (EPA) have colorectal polyp prevention activity, alone and in combination. This study measured levels of plasma and rectal mucosal oxylipins in participants of the seAFOod 2 × 2 factorial, randomised, placebo-controlled trial, who received aspirin 300 mg daily and EPA 2000 mg free fatty acid, alone and in combination, for 12 months. METHODS: Resolvin (Rv) E1, 15-epi-lipoxin (LX) A4 and respective precursors 18-HEPE and 15-HETE (with chiral separation) were measured by ultra-high performance liquid chromatography-tandem mass spectrometry in plasma taken at baseline, 6 months and 12 months, as well as rectal mucosa obtained at trial exit colonoscopy at 12 months, in 401 trial participants. RESULTS: Despite detection of S- and R- enantiomers of 18-HEPE and 15-HETE in ng/ml concentrations, RvE1 or 15­epi-LXA4 were not detected above a limit of detection of 20 pg/ml in plasma or rectal mucosa, even in individuals randomised to both aspirin and EPA. We have confirmed in a large clinical trial cohort that prolonged (12 months) treatment with EPA is associated with increased plasma 18-HEPE concentrations (median [inter-quartile range] total 18-HEPE 0.51 [0.21-1.95] ng/ml at baseline versus 0.95 [0.46-4.06] ng/ml at 6 months [P<0.0001] in those randomised to EPA alone), which correlate strongly with respective rectal mucosal 18-HEPE levels (r = 0.82; P<0.001), but which do not predict polyp prevention efficacy by EPA or aspirin. CONCLUSION: Analysis of seAFOod trial plasma and rectal mucosal samples has not provided evidence of synthesis of the EPA-derived specialised pro-resolving mediator RvE1 or aspirin-trigged lipoxin 15­epi-LXA4. We cannot rule out degradation of individual oxylipins during sample collection and storage but readily measurable precursor oxylipins argues against widespread degradation.

Genomic characterisation of hormone receptor-positive breast cancer arising in very young women.

BACKGROUND: Very young premenopausal women diagnosed with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+HER2-) early breast cancer (EBC) have higher rates of recurrence and death for reasons that remain largely unexplained. PATIENTS AND METHODS: Genomic sequencing was applied to HR+HER2- tumours from patients enrolled in the Suppression of Ovarian Function Trial (SOFT) to determine genomic drivers that are enriched in young premenopausal women. Genomic alterations were characterised using next-generation sequencing from a subset of 1276 patients (deep targeted sequencing, n = 1258; whole-exome sequencing in a young-age, case-control subsample, n = 82). We defined copy number (CN) subgroups and assessed for features suggestive of homologous recombination deficiency (HRD). Genomic alteration frequencies were compared between young premenopausal women (<40 years) and older premenopausal women (≥40 years), and assessed for associations with distant recurrence-free interval (DRFI) and overall survival (OS). RESULTS: Younger women (<40 years, n = 359) compared with older women (≥40 years, n = 917) had significantly higher frequencies of mutations in GATA3 (19% versus 16%) and CN amplifications (CNAs) (47% versus 26%), but significantly lower frequencies of mutations in PIK3CA (32% versus 47%), CDH1 (3% versus 9%), and MAP3K1 (7% versus 12%). Additionally, they had significantly higher frequencies of features suggestive of HRD (27% versus 21%) and a higher proportion of PIK3CA mutations with concurrent CNAs (23% versus 11%). Genomic features suggestive of HRD, PIK3CA mutations with CNAs, and CNAs were associated with significantly worse DRFI and OS compared with those without these features. These poor prognostic features were enriched in younger patients: present in 72% of patients aged <35 years, 54% aged 35-39 years, and 40% aged ≥40 years. Poor prognostic features [n = 584 (46%)] versus none [n = 692 (54%)] had an 8-year DRFI of 84% versus 94% and OS of 88% versus 96%. Younger women (<40 years) had the poorest outcomes: 8-year DRFI 74% versus 85% and OS 80% versus 93%, respectively. CONCLUSION: These results provide insights into genomic alterations that are enriched in young women with HR+HER2- EBC, provide rationale for genomic subgrouping, and highlight priority molecular targets for future clinical trials.

Preoperative Simulation of Retropubic Midurethral Sling to Decrease Bladder Perforation Rate Among Obstetrics and Gynecology Residents.

IMPORTANCE: Bladder perforation is an often avoidable complication of retropubic midurethral sling procedures. Bladder injury rates decrease with surgeon experience, but literature on techniques to train novice surgeons is limited. OBJECTIVE: Our objective was to decrease the bladder perforation rate among obstetrics and gynecology residents during retropubic midurethral sling procedures through implementation of an instructional video and low-fidelity simulation. STUDY DESIGN: A baseline bladder perforation rate was determined by retrospective chart review. A prospective educational intervention, consisting of a 10-minute instructional video with preoperative simulation using a simple bony pelvis model, was then implemented among residents on the urogynecology service from December 2017 through March 2020. The primary outcome was the change in the bladder perforation rate. Compliance with the intervention protocol was a secondary outcome. Categorical data were evaluated using the χ 2 or Fisher exact test. Continuous variables were assessed using the Student t test or Mann-Whitney U test as appropriate. RESULTS: Two hundred fifteen retropubic midurethral sling cases were included in analysis. There were no significant demographic differences between the patients undergoing surgery preintervention and postintervention. Resident surgeons were in their second (47.4%) and third (52.6%) years of training. The postintervention bladder perforation rate was 6.5%, which is a 35% reduction from the preintervention perforation rate of 10% ( P = 0.19). The instructional video and preoperative simulation were successfully implemented in 193 of 215 (89.8%) eligible cases. CONCLUSION: Despite high compliance, the combination of the instructional video and preoperative low-fidelity bony pelvis simulation was not effective in reducing tension-free vaginal tape-associated bladder perforations among residents.

Persistent high blood pressure and renal dysfunction in preterm infants during childhood.

BACKGROUND: Infants born very preterm (≤32 weeks gestational age, GA) and very-low birth weight (≤1500 g; PT-VLBW) demonstrate high systolic blood pressure (SBP), renal dysfunction, and obesity at 6 months-3 years and in early adulthood. Their parallel measurement and progression during childhood is unclear. METHODS: We reenrolled 62/120 patients originally seen at 1-3 years at 10-13 years and remeasured anthropometric indices, SBP, and serum creatinine (Cr) and cystatin C (cysC) to determine estimated glomerular filtration rate (eGFR). We selected Term-matched Controls at 10-13 years from the 2015-2016 NHANES database at a ratio of 2 Controls:1 Case (124:62). RESULTS: Reenrolled patients were predominantly Hispanic, birth weight 1073 ± 251 g, and GA at birth 28 ± 2 weeks. At 10-13 years, 45% were classified overweight/obese, 48% had SBP ≥ 90th centile (77% considered hypertensive), and 34% had low eGFR (<90 mL min-1 [1.73 m2]-1). Notably, 57% of reenrolled PT-VLBW Cases had low eGFRcysC at both 1-3 and 10-13 years, P < 0.03. Compared to Controls, Cases had four times the adjusted odds for having an elevated SBP and low eGFRCr despite similar proportions with overweight/obesity among Cases and Controls. CONCLUSIONS: PT-VLBW infants seen at 1-3 years exhibit obesity, elevated SBP, and low eGFR in infancy and 10-13 years. Although the small sample size may limit conclusions, pediatricians should consider serial evaluations of PT-VLBW throughout childhood. IMPACT: The association between preterm birth and elevated blood pressure, renal dysfunction, and obesity in young adults begins as early as 1 year and persists at 10-13 years of age. This is the first study reporting serial measurements of blood pressure, renal function, and obesity from infancy to preadolescence in children born very preterm. Fifty-seven percent of preterm 1-3 year olds have persistent low estimated glomerular filtration rate associated with hypertension at 10-13 years. Clinicians should consider serial evaluations of blood pressure, renal function, and obesity throughout infancy and childhood in all preterm births.

The impact of age on long-term survival following gastrectomy for gastric cancer.

INTRODUCTION: Gastrectomy remains the primary curative treatment modality for patients with gastric cancer. Concerns exist about offering surgery with a high associated morbidity and mortality to elderly patients. The study aimed to evaluate the long-term survival of patients with gastric cancer who underwent gastrectomy comparing patients aged <70 years with patients aged ≥70 years. METHODS: Consecutive patients who underwent gastrectomy for adenocarcinoma with curative intent between January 2000 and December 2017 at a single centre were included. Patients were stratified by age with a cut-off of 70 years used to create two cohorts. Log rank test was used to compare overall survival and Cox multivariable regression used to identify predictors of long-term survival. RESULTS: During the study period, 959 patients underwent gastrectomy, 520 of whom (54%) were aged ≥70 years. Those aged <70 years had significantly lower American Society of Anesthesiologists grades (p<0.001) and were more likely to receive neoadjuvant chemotherapy (39% vs 21%; p<0.001). Overall complication rate (p=0.001) and 30-day postoperative mortality (p=0.007) were lower in those aged <70 years. Long-term survival (median 54 vs 73 months; p<0.001) was also favourable in the younger cohort. Following adjustment for confounding variables, age ≥70 years remained a predictor of poorer long-term survival following gastrectomy (hazard ratio 1.35, 95% confidence interval 1.09, 1.67; p=0.006). CONCLUSIONS: Low postoperative mortality and good long-term survival were demonstrated for both age groups following gastrectomy. Age ≥70 years was, however, associated with poorer outcomes. This should be regarded as important factor when counselling patients regarding treatment options.

Non-adherence of surgical treatment in patients with non-melanoma skin cancer: a retrospective cohort pilot study.

There is limited data on non-adherence for surgical treatment in non-melanoma skin cancer (NMSC) patients. The objective of this single-center, retrospective cohort study is to compare rates of non-adherence of surgical treatment options, determine factors associated with non-adherence, and identify barriers for non-adherence. All adult patients with NMSC (> 18 years) seen between 2015 and 2017 recommended surgical treatment (surgical excision and electrodessication and curettage (ED&C) or Mohs surgery) were eligible. Non-adherence was defined as not completing recommended treatment and reasons for non-adherence were collected. Out of 427 patients that met inclusion criteria, patients recommended surgical excision and ED&C had a lower non-adherence rate of 3.4% compared to those recommended Mohs (11.4%) (p = 0.006). Factors associated with non-adherence included self-pay patients (19.07% adherent vs. 43.24% non-adherent, p = 0.004). Multivariate logistic regression analysis confirmed that Mohs patients were more likely to be non-adherent (odds ratio (OR) = 3.839, 95% confidence interval (CI) (1.435-10.270), p = 0.007) compared to surgical excision and ED&C patients. Males were more likely to be non-adherent (OR = 2.474, 95% CI (1.105-5.542), p = 0.028) to females, and self-pay patients were more likely to be non-adherent than those with other payers (OR = 3.050, 95% CI (1.437-6.475), p = 0.004). Of the 37 patients who were non-adherent, the most common reasons were loss to follow-up (46%), social reasons (41%), medical reasons (38%), and financial reasons (22%). There was a significant difference in non-adherence rates between surgical treatments for NMSCs in our cohort. Our study suggests the need for future interventional studies that implement strategies and patient education to decrease non-adherence rates.

Occult tension pneumothorax discovered following imaging for adult trauma patients in the modern major trauma system: a multicentre observational study.

BACKGROUND: Tension pneumothorax following trauma is a life-threatening emergency and radiological investigation is normally discouraged prior to treatment in traditional trauma doctrines such as ATLS. Some trauma patients may be physiologically stable enough for diagnostic imaging and occult tension pneumothorax is discovered radiologically. We assessed the outcomes of these patients and compared them with those with clinical diagnosis of tension pneumothorax prior to imaging. METHODS: A multicentre civilian-military collaborative network of six major trauma centres in the UK collected observational data from adult patients who had a diagnosis of traumatic tension pneumothorax during a 33-month period. Patients were divided into 'radiological' (diagnosis following CT/CXR) or 'clinical' (no prior CT/CXR) groups. The effect of radiological diagnosis on survival was analysed using multivariable logistic regression that included the covariates of age, gender, comorbidities and Injury Severity Score. RESULTS: There were 133 patients, with a median age of 41 (IQR 24-61); 108 (81%) were male. Survivors included 49 of 59 (83%) in the radiological group and 59 of 74 (80%) in the clinical group (p=0.487). Multivariable logistic regression showed no significant association between radiological diagnosis and survival (OR 2.40, 95% CI 0.80 to 7.95; p=0.130). There was no significant difference in mortality between the groups. CONCLUSION: Radiological imaging may be appropriate for selected trauma patients at risk of tension pneumothorax if they are considered haemodynamically stable. Trauma patients may be physiologically stable enough for radiological imaging but have occult tension pneumothorax because they did not have the typical clinical presentation. The historical dogma of the 'forbidden scan' no longer applies to such patients.

The Effect of Patient Opioid Education on Opioid Use, Storage, and Disposal Patterns.

We evaluated the impact of patient education over opioid use, storage, and disposal on opioid handling patterns of palliative and chronic nonmalignant pain patients. We compared patient surveys before and after education and conducted further analysis for individual clinics due to group differences found prior to education. A total of 100 patients were included. After education, more patients reported never sharing their prescription opioid (95% vs. 66%; P < 0.01), and all reported awareness that one dose could be harmful to someone else (100% vs. 31%; P < 0.01). In addition, more patients reported locking their opioid for storage (85% vs. 13%; P < 0.01). Lastly, less patients reported leftover opioids (2% vs. 40%; P < 0.01), not always disposing (1% vs. 44%; P < 0.01), or purposefully saving (0% vs. 15%; P < 0.01), and all reported knowing the right way to dispose (100% vs. 14%; P < 0.01). Proper methods of disposal increased, including mixing with unpalatable substances (96% vs. 13%; P < 0.01) and utilizing drug-take-back programs (78% vs. 24%; P < 0.01). This project found that patient education improves knowledge and behavior related to opioid handling patterns. Further initiatives should help to identify higher-risk patients and develop educational tools.

Online training resources to aid therapeutic radiographers in engaging in conversations about physical activity and diet: A mixed methods study.

INTRODUCTION: This study explored changes in therapeutic radiographers' (TRs) self-reported knowledge and skills to engage in conversations about physical activity and diet with people living with and beyond cancer following completion of publicly available online courses. METHODS: Participants were randomly assigned to two of five online courses that aim to support health professionals to engage in conversations about physical activity and diet in the oncology setting. Participants rated their agreement with 18 statements related to the COM-B (capability, opportunity and motivation-behaviour) model components following completion of an online course on healthy diet (n = 16) and physical activity (n = 21). Semi-structured telephone interviews (n = 21) were also conducted. Analysis of the interviews was guided by the Theoretical Domains Framework. RESULTS: Overall, the online courses were acceptable and the TRs in this study self-reported improved COM to deliver advice on physical activity and diet. The inclusion of the evidence and scientific rationale on the benefits of diet and physical activity, and also guidance on how to start conversations with patients were highlighted as important features of the courses. Suggestions for adaptations to the nutrition courses included the need for content that accounts for the side effects cancer patients experience while undergoing treatment. To support the implementation of training and the delivery of advice on these topics, multi-disciplinary working, organisational support and guidance around professional role boundaries were highlighted as important. CONCLUSION: Current publicly available online courses on physical activity and diet for oncology health professionals can reduce some barriers among TRs to providing advice to those living with and beyond cancer. IMPLICATIONS FOR PRACTICE: Existing online training courses could be used to support TRs to deliver physical activity and dietary advice in practice. Findings show that these courses can be disseminated within radiotherapy departments. The results also highlight a number of important considerations for the implementation of brief health behaviour advice and online training interventions on physical activity and diet within cancer care.

The junior doctor changeover effect: does it exist in general surgery?

INTRODUCTION: Junior doctor changeover has been perceived as a period of increased risk to patients. However, there is a paucity of contemporary evidence of this 'changeover effect'. The aim of this study was to evaluate the presence of an adverse patient effect during periods of junior doctor changeover. METHODS: Data were requested on all patients aged 18 years or older admitted acutely under General Surgery in the North of England between 2005 and 2016. This included patient characteristics, diagnoses, comorbidities, procedure codes, mortality and length of stay. Patients were included in the study if they were admitted during the 'changeover week'; defined as the first day of the changeover followed by the six subsequent days. For junior trainees (FY1-CT2), this is the first Wednesday of August, December and April each year. For higher surgical trainees (ST3-ST8), it is the first Wednesday in October. Another week, four weeks prior, was chosen as a historical comparator. RESULTS: In total, 61,714 patients were included in this study. Patient characteristics did not vary between the cohorts. There was no difference in 30-day mortality between changeover and non-changeover groups (2.5% vs 2.6%, p = 0.280) or length of stay (5.3 vs 5.2, p = 0.613). Changeover week was not a predictor of increased mortality (OR 1.06, p = 0.302) following multivariable adjustment. Further analysis of the first junior and higher specialty trainee periods, August and October, respectively, showed no significant difference for measured outcomes. CONCLUSIONS: This retrospective cohort study provides contemporary evidence that the 'changeover effect' does not exist in acute general surgical admissions in the UK.

The feasibility of home monitoring of young people with cystic fibrosis: Results from CLIMB-CF.

BACKGROUND: CF is traditionally assessed in clinic. It is unclear if home monitoring of young people with CF is feasible or acceptable. The COVID-19 pandemic has made home monitoring more of a necessity. We report the results of CLIMB-CF, exploring home monitoring's feasibility and potential obstacles. METHODS: We designed a mobile app and enrolled participants with CF aged 2-17 years and their parents for six months. They were asked to complete a variety of measures either daily or twice a week. During the study, participants and their parents completed questionnaires exploring depression, anxiety and quality of life. At the end of the study parents and participants completed acceptability questionnaires. RESULTS: 148 participants were recruited, 4 withdrew prior to starting the study. 82 participants were female with median (IQR) age 7.9 (5.2-12 years). Median data completeness was 40.1% (13.6-69.9%) for the whole cohort; when assessed by age participants aged ≥ 12 years contributed significantly less (15.6% [9.8-30%]). Data completeness decreased over time. There was no significant difference between parental depression and anxiety scores at the start and the end of the study nor in CFQ-R respiratory domain scores for participants ≥ 14 years. The majority of participants did not feel the introduction of home monitoring impacted their daily lives. CONCLUSIONS: Most participants felt home monitoring did not negatively impact their lives and it did not increase depression, anxiety or decrease quality of life. However, uptake was variable, and not well sustained. The teenage years pose a particular challenge and further work is required.

ReIMAGINE: a prostate cancer research consortium with added value through its patient and public involvement and engagement.

BACKGROUND: ReIMAGINE aims to improve the current prostate specific antigen (PSA)/biopsy risk stratification for prostate cancer (PCa) and develop a new image-based method (with biomarkers) for diagnosing high/low risk PCa in men. ReIMAGINE's varied patient and public involvement (PPI) and engagement (PE) strategy maximises the impact of its scientific output by informing and shaping the different stages of research. AIMS: Through including the voice of patients and the public, the ReIMAGINE Consortium aims to translate these different perspectives into the design and implementation process. This will improve the overall quality of the research by: reflecting the needs and priorities of patients and the public, ensuring methods and procedures are feasible and appropriate ensuring information is relevant and accessible to those being recruited to the study identifying dissemination channels relevant to patients/the public and developing outputs that are accessible to a lay audience With support from our patient/user groups, the ReIMAGINE Consortium aims to improve our ability to derive prognostic information and allocate men to the most appropriate and effective therapies, using a novel image-based risk stratification with investigation of non-imaging biomarkers. FINDINGS: We have been working with patients and the public from initiation of the project to ensure that the research is relevant to men and their families. Our PPI Sub-Committee, led by a PCa patient, has been involved in our dissemination strategy, outreach activities, and study design recommendations. For example, the sub-committee have developed a variety of informative videos relevant and accessible to those being recruited, and organised multiple online research engagement events that are accessible to a lay audience. As quoted by one of the study participants, "the more we present the benefits and opportunities to patients and the public, the more research commitment we obtain, and the sooner critical clinical questions such as PCa diagnostics will be addressed".

One in eight men will be diagnosed with prostate cancer (PCa). Most will not die of it, but our ability to identify those men whose cancer poses the greatest threat to life has, thus far, been poor. Some men are diagnosed with small cancers which will never cause them a problem, some will have treatment which is unnecessary, others will have their cancers missed, and others will be misclassified as either having low risk cancer and will therefore miss out on the appropriate treatment, or told their cancer is high risk and have unnecessary treatment. Nowhere else in modern medicine are these errors of over-diagnosis, over-treatment, missed-diagnoses, and poor risk-stratification more common. The ReIMAGINE Consortium has been developed to undertake discoveries that will correct these four key errors in the PCa diagnostic pathway. We will investigate how to best identify which men have, or will develop, aggressive prostate cancer using imaging combined with advanced biomarker analyses of blood and urine (i.e., OMICs technologies such as whole genome sequencing, targeted sequencing (e.g.: = , methylation). We will achieve this by building on established partnerships between patients, advocacy organisations, clinicians, imaging experts, molecular biologists, methodologists, and a broad range of industrial partners.The Patient and Public Involvement (PPI) sub-committee is an integral part of the study workflow, contributing to study design and recruitment, results analysis, and dissemination. The committee, led by a funded PPI co-ordinator and a patient chair, have given invaluable insight into the study modifications due to COVID-19 restrictions.

Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial.

BACKGROUND: Mogamulizumab was compared with vorinostat in the phase 3 MAVORIC trial (NCT01728805) in 372 patients with relapsed/refractory mycosis fungoides (MF) or Sézary syndrome (SS) who had failed ≥1 prior systemic therapy. Mogamulizumab significantly prolonged progression-free survival (PFS), with a superior objective response rate (ORR) vs. vorinostat. OBJECTIVES: This post hoc analysis was performed to evaluate the effect of baseline blood tumour burden on patient response to mogamulizumab. METHODS: PFS, ORR, time to next treatment (TTNT), skin response (modified Severity-Weighted Assessment Tool [mSWAT]) and safety were assessed in patients stratified by blood classification (B0 [n = 126], B1 [n = 62], or B2 [n = 184], indicating increasing blood involvement). RESULTS: Investigator-assessed PFS was longer for mogamulizumab versus vorinostat across all blood classes, significantly so for B1 and B2 patients. ORR was higher with mogamulizumab than with vorinostat in all blood classification groups and more markedly so with escalating B class (B0: 15.6% vs. 6.5%, P = 0.0549; B1: 25.8% vs. 6.5%, P = 0.2758; B2: 37.4% vs. 3.2%, P < 0.0001). TTNT was significantly longer for patients treated with mogamulizumab versus vorinostat with B1 (12.63 vs. 3.07 months; HR 0.32 [95% CI 0.16-0.67]; P = 0.0018) and B2 (13.07 vs. 3.53 months; HR 0.30 [95% CI 0.21-0.43]; P < 0.0001) blood involvement. In the mogamulizumab arm, 81 patients (43.5%) had ≥50% change in the mSWAT vs. 41 patients (22.0%) with vorinostat; mSWAT improvements with mogamulizumab occurred most often in B1 and B2 patients. Rapid, sustained reductions were seen in CD4+ CD26- cell counts and CD4:CD8 ratios in mogamulizumab patients for all B classes. Treatment-emergent adverse events were less frequent overall with mogamulizumab and similar in frequency regardless of B class. CONCLUSIONS: This post hoc analysis indicates greater clinical benefit with mogamulizumab vs. vorinostat in patients with MF and SS classified as having B1 and B2 blood involvement.

A Systematic Review of Online Patient Resources to Support Shared Decision Making for Laparoscopic Cholecystectomy.

BACKGROUND: RCS Eng, the Royal College of Surgeons of England, has published much information with regard to the consenting process. A majority of patients seek health information through online resources as well as discussing with the care givers. Therefore, it is necessary that online material is both of high quality and reliable for patients. We aimed to evaluate the quality and standard of the online patient information on laparoscopic cholecystectomy to help in the consenting process. METHODS: A search was carried out as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Sources were assessed using five validated scoring tools: Flesch-Kincaid Reading Ease Score (readability), DISCERN and IPDAS scores (quality of content) and HONcode and the Information Standard Certification (standards of accreditation). RESULTS: The average readability of all websites was higher than recommended for patient literature. Less than half of the sources had received HONcode or Information Standard accreditation. On grading of quality and content, across validated scoring tools, no source achieved the minimum recommended level. CONCLUSION: Online patient information related to laparoscopic cholecystectomy is of poor quality. We recommend a multidisciplinary approach to participate in publishing more readable online resources of a higher standard to help patients and clinicians in consent and shared decision making.