Postoperative mortality and complications in patients with and without pre-operative SARS-CoV-2 infection: a service evaluation of 24 million linked records using OpenSAFELY.

Surgical decision-making after SARS-CoV-2 infection is influenced by the presence of comorbidity, infection severity and whether the surgical problem is time-sensitive. Contemporary surgical policy to delay surgery is informed by highly heterogeneous country-specific guidance. We evaluated surgical provision in England during the COVID-19 pandemic to assess real-world practice and whether deferral remains necessary. Using the OpenSAFELY platform, we adapted the COVIDSurg protocol for a service evaluation of surgical procedures that took place within the English NHS from 17 March 2018 to 17 March 2022. We assessed whether hospitals adhered to guidance not to operate on patients within 7 weeks of an indication of SARS-CoV-2 infection. Additional outcomes were postoperative all-cause mortality (30 days, 6 months) and complications (pulmonary, cardiac, cerebrovascular). The exposure was the interval between the most recent indication of SARS-CoV-2 infection and subsequent surgery. In any 6-month window, < 3% of surgical procedures were conducted within 7 weeks of an indication of SARS-CoV-2 infection. Mortality for surgery conducted within 2 weeks of a positive test in the era since widespread SARS-CoV-2 vaccine availability was 1.1%, declining to 0.3% by 4 weeks. Compared with the COVIDSurg study cohort, outcomes for patients in the English NHS cohort were better during the COVIDSurg data collection period and the pandemic era before vaccines became available. Clinicians within the English NHS followed national guidance by operating on very few patients within 7 weeks of a positive indication of SARS-CoV-2 infection. In England, surgical patients' overall risk following an indication of SARS-CoV-2 infection is lower than previously thought.

Claims for fertility interventions: a systematic assessment of statements on UK fertility centre websites.

OBJECTIVES: Fertility services in the UK are offered by over 200 Human Fertilisation and Embryology Authority (HFEA)-registered NHS and private clinics. While in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) form part of the National Institute for Health and Care Excellence (NICE) guidance, many further interventions are offered. We aimed to record claims of benefit for interventions offered by fertility centres via information on the centres' websites and record what evidence was cited for these claims. METHODS: We obtained from HFEA a list of all UK centres providing fertility treatments and examined their websites. We listed fertility interventions offered in addition to standard IVF and ICSI and recorded statements about interventions that claimed or implied improvements in fertility in healthy women. We recorded which claims were quantified, and the evidence cited in support of the claims. Two reviewers extracted data from websites. We accessed websites from 21 December 2015 to 31 March 2016. RESULTS: We found 233 websites for HFEA-registered fertility treatment centres, of which 152 (65%) were excluded as duplicates or satellite centres, 2 were andrology clinics and 5 were unavailable or under construction websites. In total, 74 fertility centre websites, incorporating 1401 web pages, were examined for claims. We found 276 claims of benefit relating to 41 different fertility interventions made by 60 of the 74 centres (median 3 per website; range 0 to 10). Quantification was given for 79 (29%) of the claims. 16 published references were cited 21 times on 13 of the 74 websites. CONCLUSIONS: Many fertility centres in the UK offer a range of treatments in addition to standard IVF procedures, and for many of these interventions claims of benefit are made. In most cases, the claims are not quantified and evidence is not cited to support the claims. There is a need for more information on interventions to be made available by fertility centres, to support well-informed treatment decisions.

Getting our house in order: an audit of the registration and publication of clinical trials supported by the National Institute for Health Research Oxford Biomedical Research Centre and the Musculoskeletal Biomedical Research Unit.

OBJECTIVES: To audit the proportion of clinical trials that had been publically registered and, of the completed trials, the proportion published. SETTING: 2 major research institutions supported by the National Institute of Health Research (NIHR). PRIMARY AND SECONDARY OUTCOME MEASURES: The proportion of trials reporting results within 12 months, 24 months and 'ever'. Factors associated with non-publication were analysed using logistic regression. INCLUSION CRITERIA: Phases 2-4 clinical trials identified from internal documents and publication lists. RESULTS: In total, 286 trials were identified. We could not find registration for 4 (1.4%) of these, all of which were completed and published. Of the trials with a registered completion date pre-January 2015, just over half (56%) were published, and half of these were published within 12 months (36/147, 25%). For some trials, information on the public registers was found to be out-of-date and/or inaccurate. No clinical trial characteristics were found to be significantly associated with non-publication. We have produced resources to facilitate similar audits elsewhere. CONCLUSIONS: It was feasible to conduct an internal audit of registration and publication in 2 major research institutions. Performance was similar to, or better than, comparable cohorts of trials sampled from registries. The major resource input required was manually seeking information: if all registry entries were maintained, then almost the entire process of audit could be automated--and routinely updated--for all research centres and funders.

Functional heterogeneity of left inferior frontal cortex as revealed by fMRI.

Using functional magnetic resonance imaging (fMRI), we mapped brain activity in six normal volunteers during two silent verbal fluency tasks, one with a phonemic (letter) cue and one with a semantic (category) cue. In comparison with resting state, both tasks activated the anterior triangular portion of the left inferior frontal gyrus (IFG or F3, for third frontal gyrus) and the left thalamus. There were also areas activated in one task but not in the other: the posterior opercular portion of the left IFG for phonemic fluency, and the left retrosplenial region for semantic fluency. Our findings concur with normal psychophysical data and neuropsychological observations to suggest the recruitment of two overlapping but dissociable systems for the two tasks, and demonstrate functional heterogeneity within the left IFG (Broca's area), where the opercular portion is responsible for obtaining access to words through a phonemic/articulatory route.