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New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears. We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590. Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design –4·2 [95% CI –8·2 to –0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups. In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears. Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership

This qualitative case study focused on an eight-day field experience course developed using Kolb's model of experiential learning (1984) and guided by the Knowles et al. (2005) theory of adult learning. The field experience encouraged students to embrace their education by developing as an individual, inquiring into the unknown or misunderstood and exploring unfamiliar environments. Thirteen undergraduate students and one graduate student were exposed to cultures and beliefs not necessarily familiar or similar to their own. Cohort members reflected multiple times during the course. Data were analyzed using qualitative methods to reveal the limpacts of the experiential learning instances of the experience. Seven major themes were revealed in students' reflections: emotion, service, culture, barriers/ risk, professionalism, career and desire to know. As educators, it is important to look at opportunities to incorporate both small-and large-scale field experiences into course curriculum. The emphasis on study abroad programs is evident at many universities and, in some cases, overshadows the unique experiences that could occur during a domestic study away. Thus, it is important that educators do not overlook the opportunities for high-impact learning to occur within the bounds of the United States.

The Prince George's County police union, the target of criticism last summer from the county NAACP and members of the black community, elected its first black president yesterday.

[James Swan] said last night that he will support [Darryl Jones]'s efforts as president. \"The elections are over and I support Darryl, and I hope that we can work together on whatever needs to be done,\" Swan said. The rejected contract, which would have increased retirement benefits but weakened disability payments, apparently was a key factor in the election, many FOP members said. Jones, who was aligned with the FOP administration and seen as favoring the proposed settlement, gained heavy support from the union's retirees and members of the special investigative units. The FOP handed [Alex Williams] a vote of no confidence after the state's attorney alleged that the [Gregory Habib] grand jury, which returned three misdemeanor indictments against one of the four white officers, had been tainted by possible tampering, obstruction of justice and perjury. State Prosecutor Stephen Montanarelli, who determined that Habib's death was accidental, found Williams's allegations baseless and dropped the indictments against the officer.

[Michael Barrymore] hit Soho at around 10.30pm on Thursday, where he ordered a bottle of champagne for his four friends at the Shadow Lounge. It advertises itself as \"London's only dedicated gay lounge and nightclub\". After 30 minutes, Barrymore and his friends moved on to a gay rave at the Mean Fiddler nightclub and stayed until 3am. Yesterday, a spokesman for the Manto bar said: \"We have a lot of celebrities. They come here to relax.\" Barrymore appeared on ITV's Tonight With Trevor McDonald last Tuesday, claiming he had been shocked into giving up his wild nights of drunken excess after party guest Stuart Lubbock drowned at his Essex mansion.

We used the BinaxNOW COVID-19 Ag Card to screen 1,540 asymptomatic college students for severe acute respiratory syndrome coronavirus 2 in a low-prevalence setting. Compared with reverse transcription PCR, BinaxNOW showed 20% overall sensitivity; among participants with culturable virus, sensitivity was 60%. BinaxNOW provides point-of-care screening but misses many infections.

We undertook a randomised, double-blinded, placebo-controlled, crossover trial to test whether intake of artificial food colour and additives (AFCA) affected childhood behaviour. 153 3-year-old and 144 8/9-year-old children were included in the study. The challenge drink contained sodium benzoate and one of two AFCA mixes (A or B) or a placebo mix. The main outcome measure was a global hyperactivity aggregate (GHA), based on aggregated z-scores of observed behaviours and ratings by teachers and parents, plus, for 8/9-year-old children, a computerised test of attention. This clinical trial is registered with Current Controlled Trials (registration number ISRCTN74481308). Analysis was per protocol. 16 3-year-old children and 14 8/9-year-old children did not complete the study, for reasons unrelated to childhood behaviour. Mix A had a significantly adverse effect compared with placebo in GHA for all 3-year-old children (effect size 0·20 [95% CI 0·01–0·39], p=0·044) but not mix B versus placebo. This result persisted when analysis was restricted to 3-year-old children who consumed more than 85% of juice and had no missing data (0·32 [0·05–0·60], p=0·02). 8/9-year-old children showed a significantly adverse effect when given mix A (0·12 [0·02–0·23], p=0·023) or mix B (0·17 [0·07–0·28], p=0·001) when analysis was restricted to those children consuming at least 85% of drinks with no missing data. Artificial colours or a sodium benzoate preservative (or both) in the diet result in increased hyperactivity in 3-year-old and 8/9-year-old children in the general population.

Background The objective of our investigation was to better understand barriers to implementation of self-administered antigen screening testing for SARS-CoV-2 at institutions of higher education (IHE). Methods Using the Quidel QuickVue At-Home COVID-19 Test, 1347 IHE students and staff were asked to test twice weekly for seven weeks. We assessed seroconversion using baseline and endline serum specimens. Online surveys assessed acceptability. Results Participants reported 9971 self-administered antigen test results. Among participants who were not antibody positive at baseline, the median number of tests reported was eight. Among 324 participants seronegative at baseline, with endline antibody results and ≥ 1 self-administered antigen test results, there were five COVID-19 infections; only one was detected by self-administered antigen test (sensitivity = 20%). Acceptability of self-administered antigen tests was high. Conclusions Twice-weekly serial self-administered antigen testing in a low prevalence period had low utility in this investigation. Issues of testing fatigue will be important to address in future testing strategies.

The two types of craniopharyngioma, adamantinomatous (ACP) and papillary (PCP), are clinically relevant tumours in children and adults. Although the biology of primary craniopharyngioma is starting to be unravelled, little is known about the biology of recurrence. To fill this gap in knowledge, we have analysed through methylation array, RNA sequencing and pERK1/2 immunohistochemistry a cohort of paired primary and recurrent samples (32 samples from 14 cases of ACP and 4 cases of PCP). We show the presence of copy number alterations and clonal evolution across recurrence in 6 cases of ACP, and analysis of additional whole genome sequencing data from the Children’s Brain Tumour Network confirms chromosomal arm copy number changes in at least 7/67 ACP cases. The activation of the MAPK/ERK pathway, a feature previously shown in primary ACP, is observed in all but one recurrent cases of ACP. The only ACP without MAPK activation is an aggressive case of recurrent malignant human craniopharyngioma harbouring a CTNNB1 mutation and loss of TP53 . Providing support for a functional role of this TP53 mutation, we show that Trp53 loss in a murine model of ACP results in aggressive tumours and reduced mouse survival. Finally, we characterise the tumour immune infiltrate showing differences in the cellular composition and spatial distribution between ACP and PCP. Together, these analyses have revealed novel insights into recurrent craniopharyngioma and provided preclinical evidence supporting the evaluation of MAPK pathway inhibitors and immunomodulatory approaches in clinical trials in against recurrent ACP.