Explore the vast range of titles available.

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

AbstractObjectiveTo assess the clinical and cost effectiveness of conservative management compared with laparoscopic cholecystectomy for the prevention of symptoms and complications in adults with uncomplicated symptomatic gallstone disease.DesignParallel group, pragmatic randomised, superiority trial.Setting20 secondary care centres in the UK.Participants434 adults (>18 years) with uncomplicated symptomatic gallstone disease referred to secondary care, assessed for eligibility between August 2016 and November 2019, and randomly assigned (1:1) to receive conservative management or laparoscopic cholecystectomy.InterventionsConservative management or surgical removal of the gallbladder.Main outcome measuresThe primary patient outcome was quality of life, measured by area under the curve, over 18 months using the short form 36 (SF-36) bodily pain domain, with higher scores (range 0-100) indicating better quality of life. Other outcomes included costs to the NHS, quality adjusted life years (QALYs), and incremental cost effectiveness ratio.ResultsOf 2667 patients assessed for eligibility, 434 were randomised: 217 to the conservative management group and 217 to the laparoscopic cholecystectomy group. By 18 months, 54 (25%) participants in the conservative management arm and 146 (67%) in the cholecystectomy arm had received surgery. The mean SF-36 norm based bodily pain score was 49.4 (standard deviation 11.7) in the conservative management arm and 50.4 (11.6) in the cholecystectomy arm. The SF-36 bodily pain area under the curve up to 18 months did not differ (mean difference 0.0, 95% confidence interval −1.7 to 1.7; P=1.00). Conservative management was less costly (mean difference −£1033, (−$1334; −€1205), 95% credible interval −£1413 to −£632) and QALYs did not differ (mean difference −0.019, 95% credible interval −0.06 to 0.02).ConclusionsIn the short term (≤18 months), laparoscopic surgery is no more effective than conservative management for adults with uncomplicated symptomatic gallstone disease, and as such conservative management should be considered as an alternative to surgery. From an NHS perspective, conservative management may be cost effective for uncomplicated symptomatic gallstone disease. As costs, complications, and benefits will continue to be incurred in both groups beyond 18 months, future research should focus on longer term follow-up to establish effectiveness and lifetime cost effectiveness and to identify the cohort of patients who should be routinely offered surgery.Trial registrationISRCTN registry ISRCTN55215960.

IntroductionEpidemiological evidence supports an association between higher levels of physical activity and improved cancer survival. Trial evidence is now needed to demonstrate the effect of exercise in a clinical setting. The Exercise during CHemotherapy for Ovarian cancer (ECHO) trial is a phase III, randomised controlled trial, designed to determine the effect of exercise on progression-free survival and physical well-being for patients receiving first-line chemotherapy for ovarian cancer.Methods and analysisParticipants (target sample size: n=500) include women with newly diagnosed primary ovarian cancer, scheduled to receive first-line chemotherapy. Consenting participants are randomly allocated (1:1) to either the exercise intervention (plus usual care) or usual care alone, with stratification for recruitment site, age, stage of disease and chemotherapy delivery (neoadjuvant vs adjuvant). The exercise intervention involves individualised exercise prescription with a weekly target of 150 minutes of moderate-intensity, mixed-mode exercise (equivalent to 450 metabolic equivalent minutes per week), delivered for the duration of first-line chemotherapy through weekly telephone sessions with a trial-trained exercise professional. The primary outcomes are progression-free survival and physical well-being. Secondary outcomes include overall survival, physical function, body composition, quality of life, fatigue, sleep, lymphoedema, anxiety, depression, chemotherapy completion rate, chemotherapy-related adverse events, physical activity levels and healthcare usage.Ethics and disseminationEthics approval for the ECHO trial (2019/ETH08923) was granted by the Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Zone) on 21 November 2014. Subsequent approvals were granted for an additional 11 sites across Queensland, New South Wales, Victoria and the Australian Capital Territory. Findings from the ECHO trial are planned to be disseminated via peer-reviewed publications and international exercise and oncology conferences.Trial registration numberAustralian New Zealand Clinical Trial Registry (ANZCTRN12614001311640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367123&isReview=true).

Nursing and allied health professionals also spend considerable time with patients developing strong therapeutic relationships fundamental to the success of challenging conversations when adjusting to incurable illness.2 3 Nevertheless, White et al’s survey noted considerable variability in the availability of palliative care and end-of-life-related content in UK-based undergraduate nursing and allied health courses. Domain Example End-of-life assessment Distinguishing between normative distress, maladjustment and mental illness Assessing cognitive function and decision-making capacity End-of-life interventions Adjusting to illness and functional limitations Pain management Improving quality-of-life and subjective well-being Interventions addressing death preparedness (eg, existential issues, legacy work and dignity therapy), death anxiety, demoralisation and (anticipatory) grief and supporting patients as they make decisions about their care Team-related and systems related skills Supporting caregivers before and after a person dies Fostering communication between patients, families and the multidisciplinary healthcare team Developing and delivering accessible community and public-facing psychoeducation around end-of-life, advance-care planning and death Supporting health professionals Providing liaison and advocacy for end-of-life care at a higher systems level There is much to be gained through better integration of psychology into end-of-life care and communication—yet currently, discipline-specific end-of-life training for psychologists appears rare. UMS-D’s end-of-life communication research program is supported by grants from the HCF Research Foundation, the Adolescent and Young Adult (AYA) Cancer Global Accord and through a clinical-academic mentoring award from the Palliative Care Clinical Academic Group of the Sydney Partnership for Health, Education, Research and Enterprise.

In her work as consultant for the child psychiatry team at Possilpark Health Centre she was widely respected for her intellectual rigour, sensitivity, subtlety, and ability to improve the emotional health of her young patients in this severely deprived area of Glasgow.

Mrs May invoked the EU’sArticle 50exit clause just before 1.30pm Brussels time when the UK’s ambassador to the EU, Sir Tim Barrow, handed in the prime minister’s “notification of withdrawal” letter to Donald Tusk, the European Council president. The British prime minister called the activation of Article 50 a “great turning point in our national story” but her remarks to the House of Commons also marked a shift to a softer tone. Mrs May said she wanted to end the role of the European Court of Justice in setting British law but has left open the possibility of some kind of ECJ role in policing issues such as trade disputes and arguments over regulatory divergence. The prime minister also hinted it might not be possible to nail down a final agreement on a trade deal within two years, saying it was vital that business should not be presented with a...

Mrs May invoked the EU'sArticle 50exit clause just before 1.30pm Brussels time when the UK's ambassador to the EU, Sir Tim Barrow, handed in the prime minister's \"notification of withdrawal\" letter to Donald Tusk, the European Council president. The British prime minister called the activation of Article 50 a \"great turning point in our national story\" but her remarks to the House of Commons also marked a shift to a softer tone. Mrs May said she wanted to end the role of the European Court of Justice in setting British law but has left open the possibility of some kind of ECJ role in policing issues such as trade disputes and arguments over regulatory divergence. The prime minister also hinted it might not be possible to nail down a final agreement on a trade deal within two years, saying it was vital that business should not be presented with a...

Mrs May's stated desire for a \"deep and special partnership\" combined with a veiled threat that a complete break from Europe could harm EU security was reinforced by Amber Rudd, the home secretary, who noted Britain was the biggest contributor to Europol, the EU crime-fighting body. Mrs May also called for early technical talks on a \"bold and ambitious free trade agreement\" that would cover financial services, including new mechanisms to create a level regulatory playing field between the UK and EU. Mrs May said she wanted to end the role of the European Court of Justice in setting British law but has left open the possibility of some kind of ECJ role in policing issues such as trade disputes and arguments over regulatory divergence. Chancellor Angela Merkel took ahard lineon the sequencing of the talks, saying Britain's future relationship with the EU could be discussed only after a divorce...