The use and misuse of the SCOFF screening measure over two decades: a systematic literature review.

PURPOSE: The SCOFF questionnaire was designed as a simple, memorable screening tool to raise suspicion that a person might have an eating disorder. It is over 20 years since the creation of the SCOFF, during which time it has been widely used. Considering this, we wish to review the use of the SCOFF in peer-reviewed scientific journals, and to assess whether it is being used appropriately in the manner in which it was originally devised and tested. METHODS: The Preferred Reporting Items for a Systematic Review and Meta-analysis (PRISMA) guidelines were followed, and all search strategies and methods were determined before the onset of the study. PubMed and Wiley Online Library were searched using the terms SCOFF and eating. Two reviewers were involved in the reviewing process. Criteria for appropriate use of the SCOFF were formalised with the tool's original authors. RESULTS: 180 articles were included in the final review. 48 articles had used the SCOFF appropriately, 117 articles inappropriately and 15 articles had been mixed in the appropriateness of their use. CONCLUSION: This systematic review highlights the inappropriate use of the SCOFF in diverse languages and settings. When used correctly the SCOFF has made a significant contribution to the understanding of eating disorders and its simplicity has been applauded and led to widespread use. However in over two-thirds of studies, the use of the SCOFF was inappropriate and the paper highlights how and in what way it was misused, Guidelines for the appropriate use of the SCOFF are stated. Future validation and avenues of research are suggested. LEVEL OF EVIDENCE: Level I.

Does variation of surgical technique affect native tissue anterior pelvic organ prolapse repair outcomes?

INTRODUCTION AND HYPOTHESIS: The Variation in Surgical Technique study (VaST), demonstrated the large variation in surgical techniques used in native tissue (NT) anterior pelvic organ prolapse (POP) repairs. However, there are few comparative studies of different surgical techniques. This study was aimed at exploring whether surgical technique influenced the outcomes of NT anterior POP repairs. METHODS: The surgical techniques of 22 consultant surgeons performing NT anterior POP repairs were filmed and categorised. These surgeons performed 809 anterior repairs within the PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trial (PROSPECT). Logistical regression models were used to determine the influence of the different surgical techniques on subjective and objective outcomes, using data collected during PROSPECT. RESULTS: In adjusted multivariate linear regression models, fascial-flap repair was associated with an improved subjective outcome (POP-SS) compared with midline plication (ß = -2.50 [-4.42 to -0.57]; p = 0.01). At 12 months, separate fascial defect repair was associated with a poorer objective outcome than midline plication (OR 6.06 [1.82-3.52], p = 0.006). At 24 months, deep dissection was associated with a poorer POP-SS than superficial dissection (0.32-2.60, p = 0.0). Continuous-locking closure of the skin was also associated with improved POP-SS compared with continuous non-locking closure (12 months: ß = -1.94 [-3.42 to -0.45], p = 0.01). CONCLUSION: Surgical technique may influence the outcome of native tissue anterior POP repairs. Our results should not change practice but inform future research; to develop methods of explicitly recording surgical techniques and allow confirmation of the effect of these aspects of technique on outcome.

A Randomized Trial of Intravenous Iron Supplementation and Exercise on Exercise Capacity in Iron-Deficient Nonanemic Patients With CKD.

Introduction: Patients with chronic kidney disease (CKD) are often iron deficient, even when not anemic. This trial evaluated whether iron supplementation enhances exercise capacity of nonanemic patients with CKD who have iron-deficiency. Methods: Prospective, multicenter double-blind randomized controlled trial of nondialysis patients with CKD and iron-deficiency but without anemia (Hemoglobin [Hb] >110 g/l). Patients were assigned 1:1 to intravenous (IV) iron therapy, or placebo. An 8-week exercise program commenced at week 4. The primary outcome was the mean between-group difference in 6-minute walk test (6MWT) at 4 weeks. Secondary outcomes included 6MWT at 12 weeks, transferrin saturation (TSAT), serum ferritin (SF), Hb, renal function, muscle strength, functional capacity, quality of life, and adverse events at baseline, 4 weeks, and at 12 weeks. Mean between-group differences were analyzed using analysis of covariance models. Results: Among 75 randomized patients, mean (SD) age for iron therapy (n = 37) versus placebo (n = 38) was 54 (16) versus 61 (12) years; estimated glomerular filtration rate (eGFR) (34 [12] vs. 35 [11] ml/min per 1.73 m2], TSAT (23 [12] vs. 21 [6])%; SF (57 [64] vs. 62 [33]) µg/l; Hb (122.4 [9.2] vs. 127 [13.2] g/l); 6MWT (384 [95] vs. 469 [142] meters) at baseline, respectively. No significant mean between-group difference was observed in 6MWT distance at 4 weeks. There were significant increases in SF and TSAT at 4 and 12 weeks (P < 0.02), and Hb at 12 weeks (P = 0.009). There were no between-group differences in other secondary outcomes and no adverse events attributable to iron therapy. Conclusion: This trial did not demonstrate beneficial effects of IV iron therapy on exercise capacity at 4 weeks. A larger study is needed to confirm if IV iron is beneficial in nondialysis patients with CKD who are iron-deficient.

Intratumoral pan-ErbB targeted CAR-T for head and neck squamous cell carcinoma: interim analysis of the T4 immunotherapy study.

BACKGROUND: Locally advanced/recurrent head and neck squamous cell carcinoma (HNSCC) is associated with significant morbidity and mortality. To target upregulated ErbB dimer expression in this cancer, we developed an autologous CD28-based chimeric antigen receptor T-cell (CAR-T) approach named T4 immunotherapy. Patient-derived T-cells are engineered by retroviral transduction to coexpress a panErbB-specific CAR called T1E28ζ and an IL-4-responsive chimeric cytokine receptor, 4αß, which allows IL-4-mediated enrichment of transduced cells during manufacture. These cells elicit preclinical antitumor activity against HNSCC and other carcinomas. In this trial, we used intratumoral delivery to mitigate significant clinical risk of on-target off-tumor toxicity owing to low-level ErbB expression in healthy tissues. METHODS: We undertook a phase 1 dose-escalation 3+3 trial of intratumoral T4 immunotherapy in HNSCC (NCT01818323). CAR T-cell batches were manufactured from 40 to 130 mL of whole blood using a 2-week semiclosed process. A single CAR T-cell treatment, formulated as a fresh product in 1-4 mL of medium, was injected into one or more target lesions. Dose of CAR T-cells was escalated in 5 cohorts from 1×107-1×109 T4+ T-cells, administered without prior lymphodepletion. RESULTS: Despite baseline lymphopenia in most enrolled subjects, the target cell dose was successfully manufactured in all cases, yielding up to 7.5 billion T-cells (67.5±11.8% transduced), without any batch failures. Treatment-related adverse events were all grade 2 or less, with no dose-limiting toxicities (Common Terminology Criteria for Adverse Events V.4.0). Frequent treatment-related adverse events were tumor swelling, pain, pyrexias, chills, and fatigue. There was no evidence of leakage of T4+ T-cells into the circulation following intratumoral delivery, and injection of radiolabeled cells demonstrated intratumoral persistence. Despite rapid progression at trial entry, stabilization of disease (Response Evaluation Criteria in Solid Tumors V.1.1) was observed in 9 of 15 subjects (60%) at 6 weeks post-CAR T-cell administration. Subsequent treatment with pembrolizumab and T-VEC oncolytic virus achieved a rapid complete clinical response in one subject, which was durable for over 3 years. Median overall survival was greater than for historical controls. Disease stabilization was associated with the administration of an immunophenotypically fitter, less exhausted, T4 CAR T-cell product. CONCLUSIONS: These data demonstrate the safe intratumoral administration of T4 immunotherapy in advanced HNSCC.

The HAVEN study-hydroxychloroquine in ANCA vasculitis evaluation-a multicentre, randomised, double-blind, placebo-controlled trial: study protocol and statistical analysis plan.

BACKGROUND: Patients with non-severe ANCA-associated vasculitis (AAV) are often prescribed immunosuppressive medications that are associated with severe side effects and a reduced quality of life. There is an unmet need for safer effective treatments for these patients. Hydroxychloroquine is being explored due to its effect in similar autoimmune conditions such as systemic lupus erythematosus. METHODS: Double-blind, placebo-controlled multicentre trial recruiting 76 patients across 20 sites. Participants will be randomised 1:1 to hydroxychloroquine or placebo in addition to standard of care immunosuppressive therapies over the course of 52 weeks. A phase II selection design will be used to determine hdroxychloroquine's efficacy, using prednisolone dosage and Birmingham Vasculitis Activity Score as a measure of disease activity. Secondary outcomes will explore other elements of AAV progression, including disease flares and time to remission. DISCUSSION: This trial aims to explore Hydroxychloroquine as a treatment for patients with AAV. If effective, the need for immunosuppressive treatments such as prednisolone could be reduced. Hydroxychloroquine is safer, cheaper and has fewer adverse effects than conventional immunosuppressive treatments. This could improve patient outcomes while saving money for the NHS. TRIAL REGISTRATION: ISRCTN: ISRCTN79334891. Registered 07 June 2021. EudraCT: 2018-001268-40. Registered 13 September 2019. CLINICALTRIALS: gov: NCT04316494. Registered 20 March 2020.

Clinical outcomes after total excision of transobturator tape inserted for treatment of stress urinary incontinence.

INTRODUCTION: Midurethral tapes (MUTs) were the most common surgical treatment for stress urinary incontinence (SUI) between 2008 and 2017. Transobturator tapes were introduced as a novel way to insert MUTs. Some women have experienced life-changing complications, and opt to undergo a total excision of transobturator tape (TETOT). There is a paucity in evidence about the outcomes of TETOT, which is a complex operation. This study aims to report clinical outcomes of all women who underwent TETOT in a specialist mesh center. METHODS: All women between 2017 and 2022 who underwent TETOT in one mesh center were reviewed. Background demographics and preoperative symptoms were recorded retrospectively. Outcome data were collected using patient global impression of improvement (PGI-I) scales via telephone review and analyzed using SPSS 25. RESULTS: Forty-five women underwent telephone review in May 2022, on average 27.9 months (range: 3-60) after TETOT. Mean age was 55 and body mass index (BMI): 30; 82% were postmenopausal, 20% were smokers, and 73.3% had recurrent SUI before excision. Indications for excision were infection (4%), vaginal exposure (24%), urethral perforation (9%), and chronic pain not associated with other complications (60%). Two women with recurrent SUI opted for a concomitant fascial sling; both reported a PGI of "very much improved" regarding SUI postoperatively. Only 12 women (26.5%) did not have SUI before excision; of these 9 (75%) reported new SUI postoperatively. Pain improved for 57.8%, but worsened for 24.4%. Although not statistically significant (p = 0.055), more women who underwent TETOT for pain alone reported worsening pain than those with pain with an additional complication (37% vs. 5.55%). Overall, 62.2% women felt "better" after their excision, 17.8% felt "worse." DISCUSSION: After TETOT, 62% of women felt better. Improvement in pain was reported by 58%-those with chronic pain without another complication reported improvement in pain less frequently (48% vs. 72%) and worsening pain more frequently (37% vs. 6%). Existing SUI worsened in 65% of women and 75% developed new SUI. There appears to be discordance between reporting global improvement with worsening of commonly measured clinical outcomes. CONCLUSION: Outcome data are important for counseling women about the risks and benefits of TETOT. Women and clinicians may have different attitudes to the possible benefits of TETOT, as evidenced by women reporting feeling better despite continuing pain or SUI. Conventional outcome measures do not adequately capture all outcomes that are important to patients.

Encouraging brisk walking with the free Active10 app in postnatal women who had a hypertensive pregnancy: "Just Walk It" feasibility study.

OBJECTIVE: To explore the feasibility of a future trial to investigate whether encouraging use of the free NHS smartphone app Active10 increases brisk walking and reduces blood pressure (BP) in postnatal mothers who had hypertensive disorders of pregnancy (HDP). DESIGN: 3-month feasibility study. SETTING: London maternity unit. POPULATION: 21 women with HDP. METHODS: At recruitment we recorded initial (booking) clinic BP and asked participants to complete a questionnaire. Two months after delivery all participants were sent (by post/email/WhatsApp) a "Just Walk It" leaflet encouraging them to download the Active10 app and walk briskly for at least 10 minutes/day. This was backed by a telephone call after 2-weeks. Assessments were repeated 3-months later, and included telephone interviews about the acceptability and use of Active10. MAIN OUTCOME MEASURES: Were recruitment rate, follow-up rate and acceptability/use of Active10. RESULTS: Of 28 women approached, 21 (75%, 95% CI 55.1-89.3%) agreed to participate. Age range was 21-46 years and five (24%) self-identified as black ethnicity. One woman dropped out of the study, and one became ill. The remaining participants (90%, 19/21, 95% CI 69.6-98.8%) were followed up after 3-months. Ninety-five percent (18/19) downloaded the Active10 app and 74% (14/19) continued using it at 3-months, averaging 27-minutes brisk walking/day according to Active10 weekly screenshots. Comments included: "Brilliant app", "Really motivates me". Mean BP was 130/81mmHg at booking and 124/80mmHg at 3-months follow-up. CONCLUSIONS: The Active10 app was acceptable to postnatal women after HDP and may have increased minutes of brisk walking. A future trial could explore whether this simple, low-cost intervention could reduce long-term BP in this vulnerable group.

Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption.

BACKGROUND: The CRADLE (Community blood pressure monitoring in Rural Africa: Detection of underLying pre-Eclampsia) Vital Signs Alert device-designed specifically to improve maternity care in low resource settings-had varying impact when trialled in different countries. To better understand the contextual factors that may contribute to this variation, this study retrospectively evaluated the adoption of CRADLE, during scale-up in Sierra Leone. METHODS: This was a mixed methods study. A quantitative indicator of adoption (the proportion of facilities trained per district) was calculated from existing training records, then focus groups were held with 'CRADLE Champions' in each district (n = 32), to explore adoption qualitatively. Template Analysis was used to deductively interpret qualitative data, guided by the NASSS (non-adoption, abandonment, scale-up, spread, sustainability) Framework. FINDINGS: Substantial but non-significant variation was found in the proportion of facilities trained in each district (range 59-90%) [X2 (7, N = 8) = 10.419, p = 0.166]. Qualitative data identified complexity in two NASSS domains that may have contributed to this variation: 'the technology' (for example, charging issues, difficulty interpreting device output and concerns about ongoing procurement) and 'the organisation' (for example, logistical barriers to implementing training, infighting and high staff turnover). Key strategies mentioned to mitigate against these issues included: transparent communication at all levels; encouraging localised adaptations during implementation (including the involvement of community leaders); and selecting Champions with strong soft skills (particularly conflict resolution and problem solving). CONCLUSIONS: Complexity related to the technology and the organisational context were found to influence the adoption of CRADLE in Sierra Leone, with substantial inter-district variation. These findings emphasise the importance of gaining an in-depth understanding of the specific system and context in which a new healthcare technology is being implemented. This study has implications for the ongoing scale-up of CRADLE, and for those implementing or evaluating other health technologies in similar contexts.

Many women die during pregnancy and childbirth from causes that could be prevented, and the vast majority of these deaths occur in low-resource settings. The 'CRADLE Vital Signs Alert' is a medical device that helps identify problems during pregnancy­designed specifically for healthcare professionals in low-resource settings. However, for unknown reasons, the device appears to have varying impact according to the country or setting in which it is used. This study aimed to explore in depth whether, and why, healthcare professionals in Sierra Leone adopted the device and engaged in training (or not). Between March 2020 and January 2021, the CRADLE device and training package was disseminated across 8 districts in Sierra Leone. This relied on a few healthcare workers (nominated 'CRADLE Champions') to voluntarily distribute the devices and training in their local areas. Group discussions were held with CRADLE Champions in each district after the rollout to gather their feedback. In addition, the proportion of facilities trained in each district was recorded. The study found differences in how well the device and training was adopted in each district. Common challenges reported across districts related to technological difficulties (such as issues charging the devices) and organisational barriers (such as high levels of staff turnover at facilities). These findings will help to inform future rollout of the CRADLE device and training in Sierra Leone and highlight factors that may need to be considered by those implementing other health technologies in similar settings.

The impact of pregnancy and childbirth on pelvic sensation: a prospective cohort study.

Pelvic organ prolapse, urinary, bowel and sexual dysfunction, collectively called pelvic floor dysfunction (PFD) affects 1 in 3 women and has a significant public health impact. The causes of PFD are not fully understood but involve injury to connective tissue and motor nerve during childbirth. Women with PFD also have sensory nerve impairment, and it is likely this occurs during childbirth, but this has never been investigated. In the current study 150 women underwent quantitative sensory testing for vibration sensation at the vagina and clitoris, and stretch sensation at the vagina and introitus, in the third trimester, 3 and 6 months postnatal. Antenatally vibration sensation was reduced but stretch sensation was normal. Postnatally vibration sensation deteriorated whilst stretch sensation initially deteriorated but recovered by 6 months postnatal to antenatal levels (all p < 0.001). Mode of birth had a significant impact on sensation, with caesarean section appearing neuroprotective, normal vaginal birth resulted in a transient deterioration in sensation that recovered by 6 months, whilst assisted vaginal delivery was prolonged suggesting persistent neurological impairment (all p < 0.015). Further research is required to study the clinical effect of these changes on pelvic floor dysfunction in the medium and long-term.

PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse.

INTRODUCTION AND HYPOTHESIS: Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse. METHODS: A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures. RESULTS: At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12% of women had undergone further surgery for prolapse. However, 8.4% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups. CONCLUSIONS: At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs.

The effect of intravenous iron supplementation on exercise capacity in iron-deficient but not anaemic patients with chronic kidney disease: study design and baseline data for a multicentre prospective double-blind randomised controlled trial.

BACKGROUND: Many people living with chronic kidney disease (CKD) are iron deficient, even though they may not be anaemic. The Iron and Muscle study aims to evaluate whether iron supplementation reduces symptoms of fatigue, improves muscle metabolism, and leads to enhanced exercise capacity and physical function. We report here the trial design and baseline characteristics. METHODS: This is a prospective, double-blind multicentre randomised controlled trial (RCT) including 75 non-dialysis stage 3-4 CKD patients with iron deficiency but without anaemia. Patients were randomly (1:1) assigned to either: i) intravenous iron therapy, or ii) placebo, with concurrent recruitment of eight CKD non-iron deficient participants and six healthy volunteers. The primary outcome of the study is the six-minute walk test (6MWT) distance between baseline and four-weeks. An additional exercise training programme for patients in both groups was initiated and completed between 4 and 12 weeks, to determine the effect of iron repletion compared to placebo treatment in the context of patients undertaking an exercise programme. Additional secondary outcomes include fatigue, physical function, muscle strength, muscle metabolism, quality of life, resting blood pressure, clinical chemistry, safety and harms associated with the iron therapy intervention and the exercise training intervention, and hospitalisations. All outcomes were conducted at baseline, 4, and 12 weeks, with a nested qualitative study, to investigate the experience of living with iron deficiency and intervention acceptability. The cohort have been recruited and baseline assessments undertaken. RESULTS: Seventy-five individuals were recruited. 44% of the randomised cohort were male, the mean (SD) age was 58 (14) years, and 56% were White. Body mass index was 31 (7) kg/m2; serum ferritin was 59 (45) µg/L, transferrin saturation was 22 (10) %, and haemoglobin was 125 (12) g/L at randomisation for the whole group. Estimated glomerular filtration rate was 35 (12) mL/min/1.73 m2 and the baseline 6MWT distance was 429 (174) m. CONCLUSION: The results from this study will address a substantial knowledge gap in the effects of intravenous iron therapy, and offer potential clinical treatment options, to improve exercise capacity, physical function, fatigue, and muscle metabolism, for non-dialysis patients with CKD who are iron-deficient but not anaemic. It will also offer insight into the potential novel effects of an 8-week exercise training programme. TRIAL REGISTRATION: EudraCT: 2018-000,144-25 Registered 28/01/2019.

Imminent death: clinician certainty and accuracy of prognostic predictions.

OBJECTIVES: To determine the accuracy of predictions of dying at different cut-off thresholds and to acknowledge the extent of clinical uncertainty. DESIGN: Secondary analysis of data from a prospective cohort study. SETTING: An online prognostic test, accessible by eligible participants across the UK. PARTICIPANTS: Eligible participants were members of the Association of Palliative Medicine. 99/166 completed the test (60%), resulting in 1980 estimates (99 participants × 20 summaries). MAIN OUTCOME MEASURES: The probability of death occurring within 72 hours (0% certain survival-100% certain death) for 20 patient summaries. The estimates were analysed using five different thresholds: 50/50%, 40/60%, 30/70%, 20/80% and 10/90%, with percentage values between these extremes being regarded as 'indeterminate'. The positive predictive value (PPV), negative predictive value (NPV) and the number of indeterminate cases were calculated for each cut-off. RESULTS: Using a <50% versus >50% threshold produced a PPV of 62%, an NPV of 74% and 5% indeterminate cases. When the threshold was changed to ≤10% vs ≥90%, the PPV and NPV increased to 75% and 88%, respectively, at the expense of an increase of indeterminate cases up to 62%. CONCLUSION: When doctors assign a very high (≥90%) or very low (≤10%) probability of imminent death, their prognostic accuracy is improved; however, this increases the number of 'indeterminate' cases. This suggests that clinical predictions may continue to have a role for routine prognostication but that other approaches (such as the use of prognostic scores) may be required for those cases where doctors' estimates are indeterminate.

Student and pre-registration pharmacist performance in a UK Prescribing Assessment.

Student and pre-registration pharmacist performance in a UK Prescribing Assessment': room for improvement and need for curricular change Background Increasingly the global policy direction is for patient-facing pharmacist prescribers. The 'UK Prescribing Safety Assessment' (PSA) was developed for medical graduates to demonstrate prescribing competencies in relation to the safe and effective use of medicines. Objectives To determine PSA performance of final year undergraduate student pharmacists (year 4) and pre-registration pharmacy graduates (year 5) and explore their opinions on its suitability. Setting Scotland, UK Methods Final year undergraduates (n = 238) and pre-registration pharmacists (n = 167) were briefed and undertook the PSA. PSA questions were mapped to specific thematic areas with 30 questions over 60 min. Data was analysed using descriptive statistics. A questionnaire was completed to gauge opinions on appropriateness of the PSA. Main Outcome Measure PSA scores Results Mean total PSA score for pre-registration pharmacists (64.4, SD 10) was significantly higher than for undergraduates (51.2, SD 12.0,) (p < 0.001). Pre-registration pharmacists performed significantly better across all question areas (all p < 0.001 other than 'adverse drug reactions', p < 0.01). Hospital pre-registration pharmacists performed statistically significantly better than community with higher overall scores (67.4, SD 9.8 v 63.2, SD 9.8, p < 0.05). Positive views on the appropriateness of the approach and the usability of the online interface were obtained from participants. Conclusion Hospital pre-registration pharmacists performed better than the undergraduates, but there is a need to improve prescribing skills in all, most notably in diagnostic skills. The PSA is acceptable to the participants. These results will help inform pharmacy curricula development and provides a cross-disciplinary method of assessment of prescribing competence.

Public understanding of female genital anatomy and pelvic organ prolapse (POP); a questionnaire-based pilot study.

INTRODUCTION AND HYPOTHESIS: Health literacy underpins informed consent and shared decision-making. In gynaecology, this includes understanding of normal anatomy and urogenital disease. This study evaluated public knowledge of external female genital anatomy and pelvic organ prolapse (POP). METHODS: A questionnaire study asked participants for their demographics and to label a female external genitalia diagram and included free-text questions on POP, its symptoms and treatment. Questionnaires were distributed at general outpatient (OPD) and urogynaecology (UG) departments at a UK teaching hospital. Differences in the number of correct anatomy labels between participant genders were assessed via chi-squared tests and, within female participants, multivariable linear and logistic regressions assessed associations with increasing correct anatomical labels and an understanding (versus no understanding) of POP, respectively. RESULTS: Within 191 (n = 160 OPD, n = 31 UG), 9/103 (9%) labelled all anatomical structures correctly. Females had more correct labels (median 1, IQR 0,3) versus males (median 0, IQR 0,1), P = 0.022). Higher education (vs. < secondary) and white ethnicity were associated with greater numbers of correct labels [coefficient (95% CI): 1.05 (0.14, 1.96), P = 0.024, 1.45 (0.58, 2.33), P = 0.001 respectively]. Fifty-three per cent understood POP. POP understanding increased with increasing age, white ethnicity (OR: 4.38, 95% CI: 1.36, 14.08, P = 0.013) and more correct anatomy labels (OR: 1.43, 95% CI 1.14, 1.79, P = 0.002). Of those who understood POP, only 35% identified "bulge" as a symptom and 7% physiotherapy as a treatment option. CONCLUSION: There was poor public understanding of external female genital anatomy and POP, which may have significant implications for health-seeking, shared decision-making and informed consent.

Antiseptic Skin Preparation Agents to Prevent Surgical Site Infection in Colorectal Surgery: A 3-Armed Randomized Controlled Trial.

BACKGROUND: There is much debate surrounding the ideal antiseptic skin preparation agent to reduce postoperative surgical site infection. International guidelines suggest that chlorhexidine- and alcohol-containing compounds have superior efficacy. However, there are minimal clinical trials specifically looking at skin preparation agents for colorectal surgery. OBJECTIVE: The aim of this study was to compare the efficacy of chlorhexidine in alcohol versus povidone-iodine in alcohol versus povidone-iodine in aqueous solution for the prevention of surgical site infection in colorectal surgery. DESIGN: This is a prospective, 3-armed, randomized controlled trial. SETTING: This study was conducted at the 800-bed John Hunter Hospital and Newcastle Private Hospital, with all subspecialty services in New South Wales, Australia. PATIENTS: All eligible, consenting adults undergoing colorectal surgery between July 2015 and December 2018 were included. INTERVENTIONS: Patients were andomized to receive preincision skin preparation with one of the following: chlorhexidine in 70% alcohol, povidone-iodine in 70% alcohol, or povidone-iodine in aqueous solution. MAIN OUTCOME MEASURE: The primary measure was surgical site infection within 30 days. RESULTS: A total of 482 patients were randomized to chlorhexidine in alcohol, povidone-iodine in alcohol, or aqueous povidone-iodine. The overall surgical site infection rate was 22% (107/482). There was no difference in rates of surgical site infection: 20.6% (29/141), 22.8% (44/193), and 23.0% (34/148), respectively ( p = 0.5267). There was no difference in complication rates: 54.6% (77/141), 46.1% (89/193), and 49.3% (73/148), respectively ( p = 0.1762). The median length of stay was 6 days in all 3 groups. LIMITATIONS: This is a subset analysis of a larger clinical trial for all forms of incisional surgery (the NewSKIN Prep trial), and noninferiority cannot be assessed. Changes in government regulations resulted in a change from 0.5% chlorhexidine in 70% ethanol to 2% chlorhexidine in 70% ethanol during the trial. CONCLUSION: This large, prospective, randomized clinical trial appears to indicate that there is no difference in surgical site infection, complications, or length of stay among the 3 commonest forms of skin preparation in colorectal surgery. See Video Abstract at http://links.lww.com/DCR/B875 .New Zealand Clinical Trials registry: ACTRN12615000021572Agentes antisépticos para la preparación de la piel para prevenir la infección del sitio quirúrgico en la cirugía colorrectal: un ensayo clínico aleatorizado de tres grupos. ANTECEDENTES: Existe un gran debate en torno al agente de preparación de la piel antiséptico ideal para reducir la infección posoperatoria del sitio quirúrgico. Las pautas internacionales sugieren que los compuestos que contienen clorhexidina y alcohol tienen una eficacia. Sin embargo, existen ensayos clínicos mínimos que analizan específicamente los agentes de preparación de la piel para la cirugía colorrectal. OBJETIVO: Comparar la eficacia de la clorhexidina en alcohol versus povidona yodada en alcohol versus povidona yodada en solución acuosa para la prevención de la infección del sitio quirúrgico en cirugía colorrectal. DISEO: Este es un ensayo controlado aleatorio prospectivo de tres brazos. AJUSTE: Este estudio se realizó en el Hospital John Hunter de 800 camas y el Hospital Privado de Newcastle con todos los servicios de subespecialidad en Nueva Gales del Sur, Australia. PACIENTES: Se incluyeron todos los adultos elegibles que dieron su consentimiento para someterse a una cirugía colorrectal entre julio de 2015 y diciembre de 2018. INTERVENCIONES: Aleatorizados para recibir una preparación para la piel previa a la incisión con uno de: clorhexidina en alcohol al 70%, povidona yodada en alcohol al 70% o povidona yodada en solución acuosa. MEDIDA DE RESULTADO PRINCIPAL: La medida principal fue la infección del sitio quirúrgico dentro de los 30 días. RESULTADOS: Un total de 482 pacientes fueron aleatorizados para recibir clorhexidina en alcohol, povidona yodada en alcohol o povidona yodada acuosa. La tasa global de infección del sitio quirúrgico fue del 22% (107/482). No hubo diferencias en las tasas de infección del sitio quirúrgico; 20,6% (29/141), 22,8% (44/193) y 23,0% (34/148) respectivamente; p = 0,5267. No hubo diferencia en las tasas de complicaciones; 54,6% (77/141), 46,1% (89/193) y 49,3% (73/148) respectivamente; p = 0,1762. La duración media de la estancia hospitalaria fue de 6,0 días en los tres grupos. LIMITACIONES: Este es un análisis de subconjunto de un ensayo clínico más grande para todas las formas de cirugía incisional (el ensayo NewSKIN Prep) y no se puede evaluar la no inferioridad. Los cambios en las regulaciones gubernamentales dieron como resultado un cambio de clorhexidina al 0,5% en etanol al 70% a clorhexidina al 2% en etanol al 70% durante la prueba. CONCLUSINES: Este gran ensayo clínico prospectivo y aleatorizado parece indicar que no hay diferencia en la infección del sitio quirúrgico, las complicaciones o la duración de la estancia entre las 3 formas más comunes de preparación de la piel en la cirugía colorrectal. Consulte Video Resumen en http://links.lww.com/DCR/B875 . (Traducción-Dr. Gonzalo Hagerman )Este ensayo se registró de forma prospectiva en el registro de ensayos clínicos de Australia Nueva Zelanda el 15/01/2015: ACTRN12615000021572.

Healthy Eating and Active Lifestyles for Diabetes (HEAL-D), a culturally tailored self-management education and support program for type 2 diabetes in black-British adults: a randomized controlled feasibility trial.

INTRODUCTION: Black-British communities are disproportionately affected by type 2 diabetes (T2D). Structured education programs are a core component of T2D healthcare but they are less successful in people from minority ethnic groups. Culturally tailored T2D education has demonstrated greater benefits than usual care. The aim of our study was to evaluate acceptability, fidelity and trial feasibility of the Healthy Eating and Active Lifestyles for Diabetes ('HEAL-D') culturally tailored T2D self-management education and support (DSMES) program. RESEARCH DESIGN AND METHODS: A mixed-methods randomized controlled feasibility trial in black-British adults with T2D was conducted. Participants were assigned to control (usual care) or intervention (HEAL-D; 7 sessions, 14 hours of group-based culturally tailored diet and lifestyle education, behavior change support and supervised physical activity), in a ratio of 1:1. Primary outcomes were recruitment and retention rates, intervention attendance and completion. Fidelity was assessed through observations and qualitative evaluation was undertaken with participants and educators. RESULTS: 102 patients responded to invitation letters (n=1335); 63 were randomized but 8 were subsequently deemed ineligible due to high baseline glycosylated hemoglogin (HbA1c) requiring intensive medical management or missing baseline HbA1c measurement. Of the remaining 55 participants (27 intervention, 28 control), 69% were female, 47% were of African and 51% were of Caribbean ethnicity. 93% completed the trial, providing end point data. Intervention attendance was high; 85% completed the program (attendance at ≥5 sessions), and 74% attended ≥6 sessions. The intervention was delivered with acceptable fidelity, although the qualitative evaluations identified some areas of structure and format in need of refinement. CONCLUSIONS: We have shown it is feasible to recruit and randomize black-British adults with T2D to a trial of a culturally tailored DSMES program. We have shown the intervention is highly acceptable for both patients and healthcare providers. A future trial should assess clinical and cost-effectiveness of HEAL-D. TRIAL REGISTRATION NUMBER: NCT03531177.

Comparative performance of SARS-CoV-2 lateral flow antigen tests and association with detection of infectious virus in clinical specimens: a single-centre laboratory evaluation study.

BACKGROUND: Lateral flow devices (LFDs) for rapid antigen testing are set to become a cornerstone of SARS-CoV-2 mass community testing, although their reduced sensitivity compared with PCR has raised questions of how well they identify infectious cases. Understanding their capabilities and limitations is, therefore, essential for successful implementation. We evaluated six commercial LFDs and assessed their correlation with infectious virus culture and PCR cycle threshold (Ct) values. METHODS: In a single-centre, laboratory evaluation study, we did a head-to-head comparison of six LFDs commercially available in the UK: Innova Rapid SARS-CoV-2 Antigen Test, Spring Healthcare SARS-CoV-2 Antigen Rapid Test Cassette, E25Bio Rapid Diagnostic Test, Encode SARS-CoV-2 Antigen Rapid Test Device, SureScreen COVID-19 Rapid Antigen Test Cassette, and SureScreen COVID-19 Rapid Fluorescence Antigen Test. We estimated the specificities and sensitivities of the LFDs using stored naso-oropharyngeal swabs collected at St Thomas' Hospital (London, UK) for routine diagnostic SARS-CoV-2 testing by real-time RT-PCR (RT-rtPCR). Swabs were from inpatients and outpatients from all departments of St Thomas' Hospital, and from health-care staff (all departments) and their household contacts. SARS-CoV-2-negative swabs from the same population (confirmed by RT-rtPCR) were used for comparative specificity determinations. All samples were collected between March 23 and Oct 27, 2020. We determined the limit of detection (LOD) for each test using viral plaque-forming units (PFUs) and viral RNA copy numbers of laboratory-grown SARS-CoV-2. Additionally, LFDs were selected to assess the correlation of antigen test result with RT-rtPCR Ct values and positive viral culture in Vero E6 cells. This analysis included longitudinal swabs from five infected inpatients with varying disease severities. Furthermore, the sensitivities of available LFDs were assessed in swabs (n=23; collected from Dec 4, 2020, to Jan 12, 2021) confirmed to be positive (RT-rtPCR and whole-genome sequencing) for the B.1.1.7 variant, which was the dominant genotype in the UK at the time of study completion. FINDINGS: All LFDs showed high specificity (≥98·0%), except for the E25Bio test (86·0% [95% CI 77·9-99·9]), and most tests reliably detected 50 PFU/test (equivalent SARS-CoV-2 N gene Ct value of 23·7, or RNA copy number of 3 × 106/mL). Sensitivities of the LFDs on clinical samples ranged from 65·0% (55·2-73·6) to 89·0% (81·4-93·8). These sensitivities increased to greater than 90% for samples with Ct values of lower than 25 for all tests except the SureScreen fluorescence (SureScreen-F) test. Positive virus culture was identified in 57 (40·4%) of 141 samples; 54 (94·7%) of the positive cultures were from swabs with Ct values lower than 25. Among the three LFDs selected for detailed comparisons (the tests with highest sensitivity [Innova], highest specificity [Encode], and alternative technology [SureScreen-F]), sensitivity of the LFDs increased to at least 94·7% when only including samples with detected viral growth. Longitudinal studies of RT-rtPCR-positive samples (tested with Innova, Encode, and both SureScreen-F and the SureScreen visual [SureScreen-V] test) showed that most of the tests identified all infectious samples as positive. Test performance (assessed for Innova and SureScreen-V) was not affected when reassessed on swabs positive for the UK variant B.1.1.7. INTERPRETATION: In this comprehensive comparison of antigen LFDs and virus infectivity, we found a clear relationship between Ct values, quantitative culture of infectious virus, and antigen LFD positivity in clinical samples. Our data support regular testing of target groups with LFDs to supplement the current PCR testing capacity, which would help to rapidly identify infected individuals in situations in which they would otherwise go undetected. FUNDING: King's Together Rapid COVID-19, Medical Research Council, Wellcome Trust, Huo Family Foundation, UK Department of Health, National Institute for Health Research Comprehensive Biomedical Research Centre.