Experiences of wearing support garments by people living with a urostomy.

BACKGROUND: support garments are commonly worn by people with a urostomy but there are no published data about their experiences of doing so. AIMS: to identify the views of people living with a urostomy on the role of support garments. METHODS: a cross-sectional survey of the stoma population's experiences of support garments was conducted in 2018. Recruitment was by social media. The free-text responses provided by a sub-sample of 58 people out of 103 respondents with a urostomy, were analysed. FINDINGS: thematic analysis revealed four themes: physical self-management; psychosocial self-management; lifestyle; and healthcare advice and support. There were mixed feelings about the value of support garments. Many cited a sense of reassurance and confidence and being able to be more sociable and active; others reported discomfort and uncertainty about their value. CONCLUSION: these findings add new understanding of experiences of support garments and provide novel theoretical insights about life with a urostomy.

Teaching webside manner: development and initial evaluation of a video consultation skills training module for undergraduate medical students.

BACKGROUND: Video consultations are increasingly used to communicate with patients, particularly during the current COVID-19 pandemic. However, training in video consultation skills receives scant attention in the literature. We sought to introduce this important topic to our undergraduate medical school curriculum. OBJECTIVE: To increase final year medical students' video consultation skills and knowledge. METHODS: We used Plan, Do, Study, Act (PDSA) quality improvement methodology with a pre-post study design to develop a teaching session for 5th year medical students, informed by a literature review and online clinician survey. The 2 hour session comprised an introduction and three practical stations: patient selection and ethics, technology and example videos, and simulation. Subjective pre- and post-session confidence was reported by students across seven domains using 5-point scales (1: not at all confident; 5: extremely confident). Students and facilitators completed post-session feedback forms. RESULTS: The 40 students and 3 facilitators who attended, over two separate teaching sessions, provided unanimously positive feedback. All students considered the session relevant. Subjective confidence ratings (n = 34) significantly increased from pre- to post-session (mean increase 1.78, p < 0.001). CONCLUSIONS: The inaugural teaching session was well-received and subjective assessment measures showed improvement in taught skills. This pilot has informed a UK-wide multi-centre study with subjective and objective data collection.

Videoconference clinics improve efficiency of inflammatory bowel disease care in a remote and rural setting.

INTRODUCTION: Patients with inflammatory bowel disease (IBD) require long-term secondary care with periodic specialist follow-up. This can be especially challenging for patients living in remote areas. One possible solution is the implementation of videoconference (VC) clinics as a distance-management tool. Here we assessed the use of VC clinics for IBD in terms of patient safety and economic benefit for patients with IBD living in rural areas in the Scottish Highlands and Islands. METHODS: Eighty-eight patients participating in the IBD specialist nurses VC clinic administered via Raigmore Hospital, Inverness, Scotland, UK, between January 2016 and June 2017 were included in this study. A total of 229 appointments were assessed. RESULTS: We found the use of a VC clinic to be safe and effective as only 0.9% of appointments required urgent medical assessment and 92% of the VC clinic appointments resulted in further VC clinic follow-up. A total travelling distance of 72,245.3 km and a total travelling time of 71,688 minutes were saved in this patient cohort. It was shown that an average of US$36.61 of potential travelling cost could be saved per appointment. DISCUSSION: VC clinics represent a patient-centred participatory model of care for IBD patients living in remote areas with enormous time- and cost-saving potential while being safe and effective. Further investigations into patient satisfaction and the combination with other telemedicine tools such as telephone conferencing and mobile phone applications are needed to evaluate the full potential of the concept.

A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study.

BACKGROUND: Haemorrhoids are a benign anorectal condition and are highly prevalent in the UK population. Treatments involve clinic-based procedures and surgery. The surgical procedures available include stapled haemorrhoidopexy (SH) and traditional haemorrhoidectomy (TH), and over 25,000 operations are performed for haemorrhoids annually in the UK. The disease is therefore important both to patients and to health service commissioners. Debate remains as to which of these surgical procedures is the most clinically effective and cost-effective. OBJECTIVE: The aim of this study was to compare the clinical effectiveness and cost-effectiveness of SH with that of TH. DESIGN: A large, open two-arm parallel-group pragmatic multicentre randomised controlled trial involving 32 UK hospitals and a within-trial cost-benefit analysis. A discrete choice experiment was conducted to estimate benefits (willingness to pay). PARTICIPANTS: Patients with grades II-IV haemorrhoids who had not previously undergone SH or TH were included in the study. INTERVENTIONS: Participants were randomised to receive either SH or TH. Randomisation was minimised at 1 : 1, in accordance with baseline EuroQol-5 Dimensions, three-level version (EQ-5D-3L) score, haemorrhoid grade, sex and centre, via an automated system. MAIN OUTCOME MEASURES: The primary outcome was area under the quality-of-life curve measured using the EQ-5D-3L descriptive system over 24 months, and the primary economic outcome was the incremental cost-effectiveness ratio. Secondary outcomes included disease-specific quality of life, recurrence, complications, further interventions and costs. RESULTS: Between January 2011 and August 2014, 777 patients were randomised (389 to receive SH and 388 to receive TH). There were 774 participants included in the analysis as a result of one post-randomisation exclusion in the SH arm and two in the TH arm. SH was less painful than TH in the short term. Surgical complications were similar in both arms. EQ-5D-3L score was higher for the SH arm in the first 6 weeks after surgery, but over 24 months the TH group had significantly better EQ-5D-3L scores (-0.073, 95% confidence interval -0.140 to -0.006; p = 0.0342). Symptoms and further interventions were significantly fewer in the TH arm at 24 months. Continence was better in the TH arm and tenesmus occurred less frequently. The number of serious adverse events reported was 24 out of 337 (7.1%) for participants who received SH and 33 out of 352 (9.4%) for those who received TH. There were two deaths in the SH arm, both unrelated to the eTHoS (either Traditional Haemorrhoidectomy or Stapled haemorrhoidopexy for haemorrhoidal disease) study. Patient preference did not seem to influence the treatment difference. SH was dominated by TH as it cost more and was less effective. The net benefit for the TH arm was higher than that for the SH arm. LIMITATIONS: Neither the participants nor the assessors were masked to treatment assignment and final recruitment was slightly short of the total target of 800. There were also substantial missing follow-up data. CONCLUSIONS: While patients who received SH had less short-term pain, after 6 weeks, recurrence rates, symptoms, re-interventions and quality-of-life measures all favoured TH. In addition, TH is cheaper. As part of a tailored management plan for haemorrhoids, TH should be considered over SH as the surgical treatment of choice for haemorrhoids refractory to clinic-based interventions. FUTURE WORK: Perform an updated meta-analysis incorporating recently conducted European trials [eTHoS, HubBLe (haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids) and LingaLongo (Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease)]. TRIAL REGISTRATION: Current Controlled Trials ISRCTN80061723. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 70. See the NIHR Journals Library website for further project information.

Experiences of recruiting to a pilot trial of Cardiac Rehabilitation In patients with Bowel cancer (CRIB) with an embedded process evaluation: lessons learned to improve recruitment.

BACKGROUND: Recruitment to randomised controlled trials (RCTs) is a perennial problem. Calls have been made for trialists to make recruitment performance publicly available. This article presents our experience of recruiting to a pilot RCT of cardiac rehabilitation for patients with bowel cancer with an embedded process evaluation. METHODS: Recruitment took place at three UK hospitals. Recruitment figures were based on the following: i) estimated number of patient admissions, ii) number of patients likely to meet inclusion criteria from clinician input and iii) recruitment rates in previous studies. The following recruitment procedure was used:Nurse assessed patients for eligibility.Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study.An appointment was made at which the patient signed a consent form and was randomised to the intervention or control group. Information about all patients considered for the study and subsequently included or excluded at each stage of the recruitment process and reasons given were recorded. RESULTS: There were variations in the time taken to award Research Management approval to run the study at the three sites (45-359 days). Sixty-two percent of the original recruitment estimate was reached. The main reason for under-recruitment was due to over-estimation of the number of patient admissions; other reasons were i) not assessing all patients for eligibility, ii) not completing a screening form for eligible patients and iii) patients who signed a screening form being lost to the study before consenting and randomisation. CONCLUSIONS: Pilot trials should not simply aim to improve recruitment estimates but should also identify factors likely to influence recruitment performance in a future trial and inform the development of that trial's recruitment strategies. Pilot trials are a crucial part of RCT design. Nevertheless, pilot trials are likely to be small scale, involving only a small number of sites, and contextual differences between sites are likely to impact recruitment performance in any future trial. This means that ongoing monitoring and evaluation in trials are likely to be required. TRIAL REGISTRATION: ISRCTN63510637; UKCRN id 14092.

Assessment of causal link between psychological factors and symptom exacerbation in inflammatory bowel disease: a protocol for systematic review of prospective cohort studies.

BACKGROUND: Inflammatory bowel disease is an idiopathic chronic disease that affects around 28 million people worldwide. Symptoms are distressing and have a detrimental effect on patients' quality of life. A possible link between exacerbation of symptoms and psychological factors has been suspected but not established. Previous reviews concerned with this link had conceptual and methodological limitations. In this paper we set out a protocol that lays the foundations for a systematic review that will address these shortcomings. The aim of this review is to provide researchers and clinicians with clarity on the role of psychological factors in inflammatory bowel disease symptom exacerbation. METHOD/DESIGN: We will identify all original, published, peer reviewed studies relevant to the topic and published in English from inception to November 2012. The databases MEDLINE, EMBASE, CINAHL and PsychINFO will be systematically searched. The search terms will include: inflammatory bowel disease, Crohn's disease, ulcerative colitis, psychological stress, mental stress, life stress, family stress, hassles, social stress, coping, mood disorders, anxiety and depression in sequential combinations.Studies will be screened according to predetermined inclusion and exclusion criteria by two reviewers. We will include clinical prospective cohort studies of all human participants aged 18 years or over with a diagnosis of inflammatory bowel disease. All eligible papers will be independently and critically appraised using the Critical Appraisal Skills Programme (CASP) tool by two reviewers. Two reviewers will independently extract and synthesise data from the studies using a predefined data extraction sheet. Disagreements will be resolved by discussion between reviewers and a third party will be consulted if agreement is not reached. Synthesised data will be analysed using Bradford Hill criterion for causality. If data permits, meta-analysis will be performed. DISCUSSION: This study will provide the most comprehensive review and synthesis of current evidence around the link between psychological factors and symptom exacerbation in inflammatory bowel disease. Results will inform clinicians in appropriate intervention development for this patient group that would reduce symptom exacerbation and therefore improve patients' quality of life.