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Outcomes important to patients with non-infectious posterior segment-involving uveitis: a qualitative study.
No full textObjective
Uveitis, a group of disorders characterised by intraocular inflammation, causes 10%-15% of total blindness in the developed world. The most sight-threatening forms of non-infectious uveitis are those affecting the posterior segment of the eye, collectively known as posterior segment-involving uveitis (PSIU). Numerous different clinical outcomes have been used in trials evaluating treatments for PSIU, but these may not represent patients' and carers' concerns. Therefore, the aims of this study were to understand the impact of PSIU on adult patients' and carers' lives and to explore what outcomes of treatment are important to them.
Methods and Analysis
Four focus group discussions were undertaken to understand the perspectives of adult patients (=18) and carers (10) with PSIU. Participants were grouped according to whether or not their uveitis was complicated by the sight-threatening condition uveitic macular oedema. Discussions were audio-recorded, transcribed and analysed using the framework analytical approach. Outcomes were identified and grouped into outcome domains.
Results
Eleven core domains were identified as important to patients and carers undergoing treatment for PSIU, comprising (1) visual function, (2) symptoms, (3) functional ability, (4) impact on relationships, (5) financial impact, (6) psychological morbidity and emotional well-being, (7) psychosocial adjustment to uveitis, (8) doctor/patient/interprofessional relationships and access to healthcare, (9) treatment burden, (10) treatment side effects, and (11) disease control.
Conclusion
The domains identified represent patients' and carers' experience and perspectives and can be used to reflect on outcomes assessed in PSIU. They will directly inform the development of a core outcome set for PSIU clinical trials
Spontaneous clearance of genital and extragenital : data from GToG.
No full textOBJECTIVES
(NG) infection can resolve without antibiotic treatment, however the literature describing the frequency of clearance at individual sites, how rapidly it occurs and potential predictive factors is limited. In this analysis of a subpopulation identified from a large multicentre UK cohort, we describe the overall rate of spontaneous clearance of infection and explore factors associated with this.
METHODS
Data from the Gentamicin compared with Ceftriaxone for the Treatment of Gonorrhoea randomised controlled trial consisting of 720 patients with NG were analysed. A subgroup of individuals had both a pretrial test sample and a trial enrolment sample taken. Those who had cleared NG between initial presentation and subsequent entry into the trial without antibiotic treatment were deemed to have spontaneously cleared. Sociodemographic characteristics, sexual history and sites of infection for those who spontaneously cleared infection were compared with that of those who did not. We also estimated the time interval to clearance.
RESULTS
Overall, the proportion who had spontaneous clearance was 20.5% (83/405). Clearance of infection occurred over a median of 10 days (IQR 7-15 days). The cohort who spontaneously cleared were similar to those who did not in terms of age, gender, sexual orientation, HIV status and previous NG infection. Chlamydia coinfection was more frequent in the 'no spontaneous clearance group' (11.1% (9/83) cf 22.0% (69/322)) (p=0.029). Dysuria was reported more often in the 'no spontaneous clearance group' (4.8% (4/83) cf 13.0% (42/322)) (p=0.035).
CONCLUSION
We present data from a large cohort of NG-infected individuals, of whom a significant proportion had spontaneous clearance of infection. This is consistent with previous smaller studies. If this is indicative of cure, point-of-care testing prior to treatment has the potential to reduce unnecessary exposure to antimicrobials. Further work to assess the importance of bacterial load, genotype and host immune response on spontaneous clearance of infection is required.
TRIAL REGISTRATION NUMBER
ISRCTN51783227
Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial.
No full textBACKGROUND
Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less.
METHODS
This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1-2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing.
FINDINGS
Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2-14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference -2·1 [95% CI -5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group).
INTERPRETATION
Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite.
FUNDING
National Institute for Health Research Health Technology Assessment Programme
Maxillofacial education in the time of COVID-19: the West Midlands experience.
No full textCOVID-19 has accelerated a reliance on virtual technology for the delivery of postgraduate surgical education. We sought to develop a regional teaching programme with robust quality assurance. Webinars were delivered on a weekly basis by subspecialty experts using Zoom™ augmented with interactive polling software. Trainee feedback comprised Likert item rating on content and delivery, free text comments and self-assessed confidence levels using visual analogue scale (VAS) scores. A focus group was also convened and transcripts assessed with grounded theory analysis. Likert items revealed 442 (93.2%) positive responses regarding content and 642 (96.7%) positive responses regarding trainer delivery. There were statistically significant improvements in VAS scores across all programme content. Key themes from the focus group analysis were the pragmatics of delivering online education, issues surrounding trainer interactivity in the virtual world, the identification of the FRCS as a driving factor and a desire for case-based content and pre-learning of information (the "flipped classroom"). We are continuing to be reactive to trainee feedback in developing our online learning programme which will also include a regional Moodle-based virtual learning environment (VLE), the subject of future educational research in our region
Global frailty: The role of ethnicity, migration and socioeconomic factors.
No full textFrailty is an important consequence of ageing, whereby frail patients are more likely to face adverse outcomes, such as disability and death. Risk of frailty increases in people with poor biological health, and has been shown in many ethnicities and countries. In economically developed countries, 10% of older adults are living with frailty. Ethnic minorities in the West face significant health inequalities. However, little is known about frailty prevalence and the nature of frailty in different ethnic groups. This has implications for healthcare planning and delivery, especially screening and the development of interventions. Global frailty prevalence is variable: low- to middle-income countries demonstrate higher rates of frailty than high-income countries, but available evidence is low. Little is known about the characteristics of these differences. However, female sex, lower economic status, lower education levels, and multimorbidity are identified risk factors. Ethnic minority migrants in economically developed countries demonstrate higher rates of frailty than white indigenous older people and are more likely to be frail when younger. Similar patterns are also seen in indigenous ethnic minority marginalised groups in economically developed countries such as the US, Australia and New Zealand, who have a higher prevalence of frailty than the majority white population. Frailty trajectories between ethnic minority migrants and white indigenous groups in high-income countries converge in the 'oldest old' age group, with little or no difference in prevalence. Frailty risk can be attenuated in migrants with improvements in integration, citizenship status, and access to healthcare. Ethnicity may play some role in frailty pathways, but, so far, the evidence suggests frailty is a manifestation of lifetime environmental exposure to adversity and risk accumulation
Determinants of lost theatre capacity.
No full textSecondary care Trusts nationwide are continuing to fail the 18-week referral to treatment (RTT) target despite several initiatives to improve theatre efficiency (2018 NHS England review). A limitation of wasted theatre productivity is required to alleviate pressures on waiting lists. Productivity, which is a measure of treatment time as a proportion of available/allocated time, takes into consideration variations in operator performance, early (non-funded) theatre starts, and over-run, and its analysis enables the determination of theatre downtime and lost theatre capacity. We monitored productivity over a 12-week period and performed downtime analysis as reported in the NHS Improvement national audit (NHSI). Results showed a marked but predictable variation in productivity connected to turnaround and session list scheduling. Productivity and booking efficiency correlated uniformly (Pearson's r=0.82). Theatre downtime was analysed with respect to three components defined in the NHSI national audit: late starts, early finish, and turnaround. We found that lost theatre time was predominantly due to early finishes; late starts were infrequent. Transport time correlated unfavourably with productivity (Pearson's r=-0.29, p=0.037) and over-run (r=0.44), and prolonged transport times were shorter when surgery was performed in a dedicated day surgery unit. Calculating the mean transport times for lists with high compared with low productivity helped us set a benchmark for patient transport times for future audit
Ultrastructure of Cell Trafficking Pathways and Coronavirus: How to Recognise the Wolf Amongst the Sheep.
No full textThe severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pandemic has resulted in an urgent need to understand the pathophysiology of SARS-CoV2 infection, to assist in the identification of treatment strategies. Viral tissue tropism is an active area of investigation, one approach to which is identification of virus within tissues by electron microscopy of post-mortem and surgical specimens. Most diagnostic histopathologists have limited understanding of the ultrastructural features of normal cell trafficking pathways, which can resemble intra- and extracellular coronavirus; in addition, viral replication pathways make use of these trafficking pathways. Herein, we review these pathways and their ultrastructural appearances, with emphasis on structures which may be confused with coronavirus. In particular, we draw attention to the fact that, when using routine fixation and processing, the typical 'crown' that characterises a coronavirus is not readily identified on intracellular virions, which are located in membrane-bound vacuoles. In addition, the viral nucleocapsid is seen as black dots within the virion and is more discriminatory in differentiating virions from other cellular structures. The identification of the viral replication organelle, a collection of membranous structures (convoluted membranes) seen at a relatively low scanning power, may help draw attention to infected cells, which can be sparse. This article is protected by copyright. All rights reserved
Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension.
No full textThe CONSORT 2010 (Consolidated Standards of Reporting Trials) statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency when evaluating new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes.The CONSORT-AI extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI. Both guidelines were developed through a staged consensus process, involving a literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed on in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants).The CONSORT-AI extension includes 14 new items, which were considered sufficiently important for AI interventions, that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human-AI interaction and providing analysis of error cases.CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer-reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes