A Single-arm, Practical Application Assessment of User Experience and Peristomal Skin Condition Among Persons With an Ileostomy Using a New Barrier Seal With Assisted Flow.

Peristomal skin complications are a common problem for persons with an ileostomy. PURPOSE: The purpose of this pilot study was to solicit user feedback and perform an initial assessment of the performance of a new barrier seal designed to decrease the risk of chemical-induced dermatitis. METHODS: Seven (7) potential participants who were at least 18 years of age, >6 months post surgery, with an end or loop ileostomy and unbroken peristomal skin, and who were capable of changing their appliance themselves or had the availability of care assistance were identified and recruited by the stoma care nurse at the University Hospital, Limerick, Ireland. At the initial visit and after 1 and 2 weeks, participants were asked to rate device comfort, security, and handling; skin condition was assessed by the research nurse using the Ostomy Skin Tool. Descriptive statistics were used to tabulate the results. RESULTS: Five (5) participants completed the study. Discoloration, erosion, and tissue overgrowth scores improved in 3 of 5 patients, and the mean Ostomy Skin Tool score decreased from 5.4 ± 2.19 at the initial assessment to 4 ± 1.87 at the week 2 visit. Comfort, handling, and security ratings increased from a median of 8 at the beginning of the study to 10 at week 2. CONCLUSION: Initial patient feedback regarding the new product was positive, and skin assessment results suggest the new seal may help improve peristomal skin condition. Larger studies with longer patient follow-up are needed to confirm the results of this pilot evaluation.

Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study.

BACKGROUND: Despite the problem of inadequate recruitment to randomised trials, there is little evidence to guide researchers on decisions about how people are effectively recruited to take part in trials. The PRioRiTy study aimed to identify and prioritise important unanswered trial recruitment questions for research. The PRioRiTy study - Priority Setting Partnership (PSP) included members of the public approached to take part in a randomised trial or who have represented participants on randomised trial steering committees, health professionals and research staff with experience of recruiting to randomised trials, people who have designed, conducted, analysed or reported on randomised trials and people with experience of randomised trials methodology. METHODS: This partnership was aided by the James Lind Alliance and involved eight stages: (i) identifying a unique, relevant prioritisation area within trial methodology; (ii) establishing a steering group (iii) identifying and engaging with partners and stakeholders; (iv) formulating an initial list of uncertainties; (v) collating the uncertainties into research questions; (vi) confirming that the questions for research are a current recruitment challenge; (vii) shortlisting questions and (viii) final prioritisation through a face-to-face workshop. RESULTS: A total of 790 survey respondents yielded 1693 open-text answers to 6 questions, from which 1880 potential questions for research were identified. After merging duplicates, the number of questions was reduced to 496. Questions were combined further, and those that were submitted by fewer than 15 people and/or fewer than 6 of the 7 stakeholder groups were excluded from the next round of prioritisation resulting in 31 unique questions for research. All 31 questions were confirmed as being unanswered after checking relevant, up-to-date research evidence. The 10 highest priority questions were ranked at a face-to-face workshop. The number 1 ranked question was "How can randomised trials become part of routine care and best utilise current clinical care pathways?" The top 10 research questions can be viewed at www.priorityresearch.ie . CONCLUSION: The prioritised questions call for a collective focus on normalising trials as part of clinical care, enhancing communication, addressing barriers, enablers and motivators around participation and exploring greater public involvement in the research process.

The role of N--acetylcysteine in the prevention of contrast-induced nephropathy in patients undergoing peripheral angiography: a structured review and meta-analysis.

Contrast-induced nephropathy (CIN) is a leading cause of hospital-acquired acute kidney injury (AKI). N-acetylcysteine (NAC) was proposed as an effective preventative measure. As data in relation to the use of NAC for the prevention of CIN in peripheral angiography are lacking, a systematic review and meta-analysis were undertaken. A comprehensive search for the published and unpublished data was performed. Data were extracted from the eligible studies. Pooled odds ratios (ORs) were used to calculate the effect of NAC on CIN incidence. Pooled effect size estimates were used to calculate the effect of NAC on serum creatinine (SCr) postcontrast. Our results showed that NAC did not reduce CIN incidence (pooled OR 1.05; 95% confidence interval [CI] 0.38-2.88; P = .92) or the mean SCr levels (pooled weighted mean difference, 4.38; 95% CI 10.4-1.65; P = .15). In conclusion, insufficient evidence exists to recommend NAC for the prevention of CIN in patients undergoing peripheral angiography.