Laparoscopic cholecystectomy versus conservative management for adults with uncomplicated symptomatic gallstones: the C-GALL RCT.

Background: Gallstone disease is a common gastrointestinal disorder in industrialised societies. The prevalence of gallstones in the adult population is estimated to be approximately 10-15%, and around 80% remain asymptomatic. At present, cholecystectomy is the default option for people with symptomatic gallstone disease.

Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial): pragmatic, multicentre randomised controlled trial.

Objective: To 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.

Design: Parallel group, pragmatic randomised, superiority trial.

Setting: 20 secondary care centres in the UK.

Sleep and Well-Being during the COVID-19 Remote and In-Person Periods: Experiences of College Faculty and Staff with and without Disabilities.

We explored the impacts of the remote and return-to-in-person work periods on sleep and well-being as reported by faculty ( = 22) and non-teaching staff ( = 21) with and without disabilities. Participants were recruited through college platforms and personal contacts. Our results show that contrary to expectations, the COVID-19 remote teaching/working period resulted in better sleep, as well as greater well-being, than the return-to-in-person work period.

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial.

Importance: Bleeding is the most common cause of preventable death after trauma.

Objective: To determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage.

Design, Setting, And Participants: Pragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK.

How to deal with a temporary suspension and restarting your trial: our experiences and lessons learnt.

Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequently restart. There is little guidance in the literature as to how to manage such a temporary suspension. In this paper, we describe the temporary suspension of a trial within our clinical trials unit because of concerns over the safety of transvaginal synthetic mesh implants.

Verifying participant-reported clinical outcomes: challenges and implications.

Background: Researchers often rely on trial participants to self-report clinical outcomes (for example, fractures, re-operations). Little information exists as to the 'accuracy' of participant-reported clinical outcomes, particularly in randomised controlled trials (RCTs). To help address this evidence gap, we report four case studies, nested within different RCTs where participant-reported clinical outcome data were compared with those reported by clinicians or extracted from medical notes.

Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation for heavy menstrual bleeding: the HEALTH RCT.

Background: Heavy menstrual bleeding (HMB) is a common problem that affects many British women. When initial medical treatment is unsuccessful, the National Institute for Health and Care Excellence recommends surgical options such as endometrial ablation (EA) or hysterectomy. Although clinically and economically more effective than EA, total hysterectomy necessitates a longer hospital stay and is associated with slower recovery and a higher risk of complications.

Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial.

Background: Heavy menstrual bleeding affects 25% of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20% of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding.

Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial.

Background: Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem.

HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial.

Background: Heavy menstrual bleeding (HMB) is a common problem affecting approximately 1.5 million women in England and Wales with a major impact on their physical, emotional, social and material quality of life. It is the fourth most common reason why women attend gynaecology outpatient clinics and accounts for one-fifth of all gynaecology outpatient referrals.

Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial.

Background: Foam sclerotherapy (foam) and endovenous laser ablation (EVLA) have emerged as alternative treatments to surgery for patients with varicose veins, but uncertainty exists regarding their effectiveness in the medium to longer term.

Objectives: To assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins.

Design: A parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation.

A randomized trial comparing treatments for varicose veins.

Background: Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain.

Methods: In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales.

Association of Hg2+ with aqueous (C60)n aggregates facilitates increased bioavailability of Hg2+ in Zebrafish (Danio rerio).

Manufactured nanoparticles (NPs) can associate with toxicants in the aqueous phase and these associations can influence the environmental fate, transport, and bioavailability of these toxicants in organisms. Dissolved metals (e.g.

Medical versus surgical management for gastro-oesophageal reflux disease (GORD) in adults.

Background: Gastro-oesophageal reflux disease (GORD) is a common condition with up to 20% of patients from Westernised countries experiencing heartburn, reflux or both intermittently. It is unclear whether medical or surgical (laparoscopic fundoplication) management is the most clinically and cost-effective treatment for controlling GORD.

Objectives: To compare the effects of medical management versus laparoscopic fundoplication surgery on health-related and GORD-specific quality of life (QOL) in adults with GORD.

Beliefs about surgery: Development and validation of an instrument to assess cognitive representations about surgery, in the context of a chronic illness.

Objectives: Within a trial of medical and surgical treatments for gastro-esophageal reflux disease (GORD), involving randomised arms and preference arms, we tested the applicability of the Beliefs about Medicines Questionnaire (BMQ) and developed and tested the validity of a new Beliefs about Surgery Questionnaire (BSQ).

Methods: Patients with GORD (N = 43) were interviewed to elicit their beliefs about medical and surgical treatments. These contributed to the development of BSQ items.

Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial.

Objective: To determine the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro-oesophageal reflux disease (GORD).

Design: Multicentre, pragmatic randomised trial (with parallel preference groups).

Setting: 21 hospitals in the United Kingdom.

The effectiveness and cost-effectiveness of minimal access surgery amongst people with gastro-oesophageal reflux disease - a UK collaborative study. The REFLUX trial.

Objectives: To evaluate the clinical effectiveness, cost-effectiveness and safety of a policy of relatively early laparoscopic surgery compared with continued medical management amongst people with gastro-oesophageal reflux disease (GORD) judged suitable for both policies.

Design: Relative clinical effectiveness was assessed by a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. The economic evaluation compared the cost-effectiveness of the two management policies in order to identify the most efficient provision of future care and describe the resource impact that various policies for fundoplication would have on the NHS.

Dates of birth and seasonal changes in well-being among 4904 subjects completing the seasonal pattern assessment questionnaire.

Background: Abnormal distributions of birthdates, suggesting intrauterine aetiological factors, have been found in several psychiatric disorders, including one study of out-patients with Seasonal Affective Disorder (S.A.D.

The development of a new measure of quality of life in the management of gastro-oesophageal reflux disease: the Reflux questionnaire.

Introduction: This paper reports on the development of a new measure of health-related quality of life for use among patients with gastro-oesophageal reflux disease (GORD), funded as part of the REFLUX trial. This is a large UK multi centre trial that aims to compare the clinical and cost effectiveness of minimal access surgery with best medical treatment for patients with GORD within the NHS.

Method: Potential items were identified via a series of interviews and focus groups carried out with patients who were receiving/had received medical or surgical treatment for GORD.

Role of L-citrulline transport in nitric oxide synthesis in rat aortic smooth muscle cells activated with LPS and interferon-gamma.

(1) l-citrulline, a coproduct of nitric oxide synthase (NOS)-catalysed metabolism of l-arginine to nitric oxide (NO), is an important intermediate of the urea cycle and a precursor for l-arginine biosynthesis in vascular cells. (2) In the present study, we have examined the characteristics of l-citrulline transport, regulation by lipopolysaccharide (LPS) and interferon-gamma (IFN-gamma) and the ability of l-citrulline to sustain NO synthesis in rat cultured aortic smooth muscle cells. (3) l-citrulline transport was saturable with an apparent Km=1.

Seasonal affective disorder and social deprivation in Aberdeen.

Background: Unlike non-seasonal depression, there is some evidence that seasonal affective disorder (SAD) is more common among more affluent socioeconomic groups.

Methods: In primary care settings in Aberdeen, 4557 subjects had previously completed a Seasonal Pattern Assessment Questionnaire (SPAQ). From the subjects' postcodes they were allocated a Carstairs score which placed them in one of seven categories of socioeconomic deprivation.

Use of health care services in seasonal affective disorder.

Background: Little is known about the presentation and management of seasonal affective disorder (SAD) in primary care.

Aims: To determine the use of health care services by people suffering from SAD.

Method: Following a screening of patients consulting in primary care, 123 were identified as suffering from SAD.

Light therapy for seasonal affective disorder in primary care: randomised controlled trial.

Background: Studies of light therapy have not been conducted previously in primary care.

Aims: To evaluate light therapy in primary care.

Method: Fifty-seven participants with seasonal affective disorder were randomly allocated to 4 weeks of bright white or dim red light.