Search

Facial skin cancer is common, and its treatment affects patient's health-related quality of life (HRQoL), as demonstrated by patient-reported outcome measures (PROMs). In this study, we anglicise and validate the novel FACE-Q Skin Cancer Module for the UK population. Anglicisation of the FACE-Q Skin Cancer Module followed international guidance for cross-cultural adaptation. Cognitive interviews were performed, producing a reconciled and harmonised version for validation. Patients undergoing facial skin cancer excision were prospectively recruited and asked to complete the anglicised FACE-Q Skin Cancer Module, along with the Skin Cancer Index (SCI) and European Quality of Life-Five Dimensions (ED-5D) questionnaire, pre-operatively and 6-8 weeks post-operatively. Data were analysed using classical test theory. Ethical approval was obtained (REC: 16/WM/0445). One hundred and ten patients were recruited between August 2017 and July 2018. Internal consistency was high (Cronbach's alpha 0.867-0.967). All subscales had a single-factor solution using principal component analysis. Construct validity, as measured between the FACE-Q subscales and SCI subscales, was good, with >75% of a priori predictions confirmed. Pearson's r for item-total correlation was >0.80 for several items, and significant ceiling effects are shown in 7 of the 10 subscales, suggesting some item redundancy. The UK version of this well-designed PROM demonstrates good face and construct validity. There is however a degree of redundancy within the scales, and further work using Rasch analysis on a larger sample will help address this., (Copyright © 2020 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Phenylketonuria (PKU) is a condition that results in the build-up of phenylalanine in the blood. This can cause severe brain damage and neurological issues if left untreated. Management can be complex and many individuals may turn to the internet to access further information. It is important that resources are understood as misinterpretation could result in harm to health. The aim of this study was to assess the readability of online resources for PKU and to assess their visual appearance using a communication sciences assessment framework. We searched the top five websites through Google using the search term "phenylketonuria/PKU". We then analysed the text content of the identified websites using five readability formulae to determine the USA and UK reading grade. The median readability level across the five websites was US grade/UK grade 10.6/11.6, with individual grades ranging from 10/11 to 13.3/14.3. We found wide differences in the focus, layout and general appearance of the websites. The readability of resources was much higher than the recommended US 6th grade level. Online resources for PKU need to be simplified to ensure they can be easily understood.

Objectives: To develop and undertake initial validation of a patient-reported outcome measure to assess health-related quality of life in patients with breast cancer-related upper limb lymphedema (ULL)., Study Design and Setting: We developed and validated the Upper Limb Lymphedema Quality of Life (ULLQoL) scale in two stages: devising the items and pretesting with patients and clinicians; longitudinal validation to test its psychometric properties-underlying dimensions, internal consistency, test-retest reliability, construct validity, and responsiveness. Patients with ULL were recruited from two outpatient clinics., Results: We derived the ULLQoL scale from a pool of 98 items generated by patients. After further consultation, we produced the draft ULLQoL scale. For validation, 103 patients with ULL completed the draft scale and two generic health measures: SF-36 and ED-5D-3L. Psychometric analysis identified two components, physical and emotional well-being, with good internal consistency and test-retest reliability. Significant correlations with SF-36, EQ-5D-3L, and percentage excess limb volume confirmed construct validity. The ULLQoL scale showed good responsiveness to change reported by lymphedema patients and moderate to large effect sizes., Conclusion: The 14-item ULLQoL scale is a robust ULL-specific measure that is feasible and valid to use in both the clinical and research settings., (Copyright © 2018 Elsevier Inc. All rights reserved.)

The use of patient-reported outcome measures (PROMs) is increasing across all medical specialties, as their importance to patient care is validated. They are likely to play a particularly important role in plastic and reconstructive surgery where outcomes are often subjective, and the recent guidance from the Royal College of Surgeons of England advising their use in cosmetic surgery highlights this. To drive their routine use across our specialty, it is important that clinicians are capable of understanding the often complex and confusing language that surrounds their design and validation. In this article, we describe the process of PROM design and validation, and we attempt to 'demystify' the language used in the health outcome literature. We present the important steps that a well-designed PROM must go through and suggest a straightforward guide for selecting the most appropriate PROMs for use in clinical practice. We hope that this will encourage greater use of PROM data across plastic and reconstructive surgery and ultimately help improve outcomes for our patients., (Copyright © 2018 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

We describe a longitudinal study carried out in an adult outbreak-associated cohort to investigate health effects, including post-infectious irritable bowel syndrome, occurring after resolution of acute Cryptosporidium parvum infection. New symptoms self-reported up to 12 months included: weight loss (31 %), abdominal pain (38 %), diarrhoea (33 %), eye pain (9 %), joint pain (33 %), fatigue (22 %) and symptoms consistent with irritable bowel syndrome (IBS) (28 %). Two people were medically diagnosed with IBS. This study describes for the first time sequelae reported by patients up to 12 months after infection with C. parvum, which appear to be similar to those described with C. hominis.

Background: Infliximab and ciclosporin are of similar efficacy in treating acute severe ulcerative colitis, but there has been no comparative evaluation of their relative clinical effectiveness and cost-effectiveness., Methods: In this mixed methods, open-label, pragmatic randomised trial, we recruited consenting patients aged 18 years or older at 52 district general and teaching hospitals in England, Scotland, and Wales who had been admitted, unscheduled, with severe ulcerative colitis and failed to respond to intravenous hydrocortisone within about 5 days. Patients were randomly allocated (1:1) to receive either infliximab (5 mg/kg intravenous infusion given over 2 h at baseline, and again at 2 weeks and 6 weeks after the first infusion) or ciclosporin (2 mg/kg per day by continuous infusion for up to 7 days, followed by twice-daily tablets delivering 5·5 mg/kg per day for 12 weeks). Randomisation used a web-based password-protected site, with a dynamic algorithm to generate allocations on request, thus protecting against investigator preference or other subversion, while ensuring that each trial group was balanced by centre, which was the only stratification used. Local investigators and participants were aware of the treatment allocated, but the chief investigator and analysts were masked. Analysis was by treatment allocated. The primary outcome was quality-adjusted survival-ie, the area under the curve (AUC) of scores from the Crohn's and Ulcerative Colitis Questionnaire (CUCQ) completed by participants at baseline, 3 months, and 6 months, then every 6 months from 1 year to 3 years. This trial is registered with the ISRCTN Registry, number ISRCTN22663589., Findings: Between June 17, 2010, and Feb 26, 2013, 270 patients were recruited. 135 patients were allocated to the infliximab group and 135 to the ciclosporin group. 121 (90%) patients in each group were included in the analysis of the primary outcome. There was no significant difference between groups in quality-adjusted survival (mean AUC 564·0 [SD 241·9] in the infliximab group vs 587·0 [226·2] in the ciclosporin group; mean adjusted difference 7·9 [95% CI -22·0 to 37·8]; p=0·603). Likewise, there were no significant differences between groups in the secondary outcomes of CUCQ scores, EQ-5D, or SF-6D scores; frequency of colectomy (55 [41%] of 135 patients in the infliximab group vs 65 [48%] of 135 patients in the ciclosporin group; p=0·223); or mean time to colectomy (811 [95% CI 707-912] days in the infliximab group vs 744 [638-850] days in the ciclosporin group; p=0·251). There were no differences in serious adverse reactions (16 reactions in 14 participants receiving infliximab vs ten in nine patients receiving ciclosporin); serious adverse events (21 in 16 patients vs 25 in 17 patients); or deaths (three in the infliximab group vs none in the ciclosporin group)., Interpretation: There was no significant difference between ciclosporin and infliximab in clinical effectiveness., Funding: NIHR Health Technology Assessment programme.

Background: There are conflicting findings regarding the impact of residential mobility on immunisation status. Our aim was to determine whether there was any association between residential mobility and take up of immunisations and whether they were delayed in administration., Methods: We carried out a cohort analysis of children born in Wales, UK. Uptake and time of immunisation were collected electronically. We defined frequent movers as those who had moved: 2 or more times in the period prior to the final scheduled on-time date (4 months) for 5 in 1 vaccinations; and 3 or more times in the period prior to the final scheduled on-time date (12 months) for MMR, pneumococcal and meningitis C vaccinations. We defined immunisations due at 2-4 months delayed if they had not been given by age 1; and those due at 12-13 months as delayed if they had not been given by age 2., Results: Uptake rates of routine immunisations and whether they were given within the specified timeframe were high for both groups. There was no increased risk (odds ratios (95% confidence intervals) between frequent movers compared to non-movers for the uptake of: primary MMR 1.08 (0.88-1.32); booster Meningitis C 1.65 (0.93-2.92); booster pneumococcal 1.60 (0.59-4.31); primary 5 in 1 1.28 (0.92-1.78); and timeliness: primary MMR 0.92 (0.79-1.07); booster Meningitis C 1.26 (0.77-2.07); booster pneumococcal 1.69 (0.23-12.14); and primary 5 in 1 1.04 (0.88-1.23)., Discussion: Findings suggest that children who move home frequently are not adversely affected in terms of the uptake of immunisations and whether they were given within a specified timeframe. Both were high and may reflect proactive behaviour in the primary healthcare setting to meet Government coverage rates for immunisation., (Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objectives: To develop a tool for the accurate reporting and aggregation of findings from each of the multiple methods used in a complex evaluation in an unbiased way., Study Design and Setting: We developed a Method for Aggregating The Reporting of Interventions in Complex Studies (MATRICS) within a gastroenterology study [Evaluating New Innovations in (the delivery and organisation of) Gastrointestinal (GI) endoscopy services by the NHS Modernisation Agency (ENIGMA)]. We subsequently tested it on a different gastroenterology trial [Multi-Institutional Nurse Endoscopy Trial (MINuET)]. We created three layers to define the effects, methods, and findings from ENIGMA. We assigned numbers to each effect in layer 1 and letters to each method in layer 2. We used an alphanumeric code based on layers 1 and 2 to every finding in layer 3 to link the aims, methods, and findings. We illustrated analogous findings by assigning more than one alphanumeric code to a finding. We also showed that more than one effect or method could report the same finding. We presented contradictory findings by listing them in adjacent rows of the MATRICS., Results: MATRICS was useful for the effective synthesis and presentation of findings of the multiple methods from ENIGMA. We subsequently successfully tested it by applying it to the MINuET trial., Conclusion: MATRICS is effective for synthesizing the findings of complex, multiple-method studies., (Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.)

Objectives: To develop and validate a gastrointestinal (GI) symptom rating questionnaire for patients with luminal GI symptoms including where no diagnosis has been made., Study Design and Setting: We developed and validated the Gastrointestinal Symptom Rating Questionnaire (GSRQ) in three stages: (1) item generation to identify the relevant items for scale inclusion; (2) development and piloting on patients with a known GI disorder; and (3) testing in a sample of trial patients. We examined the underlying dimensions of the scale, internal consistency, validity, reproducibility, and responsiveness., Results: We identified four interpretable factors on the GSRQ. The GSRQ had good internal consistency (corrected item-subscale correlations between 0.4 and 0.8) and Cronbach's alpha greater than 0.7 for each subscale. Construct validity was demonstrated by modest but significant correlations with the Short Form 36 and the EQ5D index value. We demonstrated good reproducibility with intraclass correlations for test-retest scores between 0.71 and 0.77, and significant responsiveness ratios for all subscales in patients who had improved, and in two of the subscales in patients who had deteriorated., Conclusion: The GSRQ could be a useful tool to monitor quality of life in various luminal GI conditions and where a formal diagnosis has not been made., (Copyright © 2015 Elsevier Inc. All rights reserved.)