What, how, when and who of trial results summaries for trial participants: stakeholder-informed guidance from the RECAP project.

OBJECTIVE: To generate stakeholder informed evidence to support recommendations for trialists to implement the dissemination of results summaries to participants. DESIGN: A multiphase mixed-methods triangulation design involving Q-methodology, content analysis, focus groups and a coproduction workshop (the REporting Clinical trial results Appropriately to Participants project). SETTING: Phase III effectiveness trials. PARTICIPANTS: A range of participants were included from ongoing and recently completed trials, public contributors, trialists, sponsors, research funders, regulators, ethics committee members. RESULTS: Fewer than half of the existing trial result summaries contained information on the clinical implications of the study results, an item deemed to be of high importance to participants in the Q-methodology study. Priority of inclusion of a thank you message varied depending on whether considering results for individuals or populations. The need for personally responsive modes of sharing trial result summaries was highlighted as important. Ideally, participants should be the first to know of the results with regard to the timing of sharing results summaries but given this can be challenging it is therefore important to manage expectations. In addition to patients, it was identified that it is important to engage with a range of stakeholders when developing trial results summaries. CONCLUSIONS: Results summaries for trial participants should cover four core questions: (1) What question the trial set out to answer?; (2) What did the trial find?; (3) What effect have the trial results had and how will they change National Health Service/treatment?; and (4) How can I find out more? Trial teams should develop appropriately resourced plans and consult patient partners and trial participants on how 'best' to share key messages with regard to content, mode, and timing. The study findings provide trial teams with clear guidance on the core considerations of the 'what, how, when and who' with regard to sharing results summaries.

Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review.

BACKGROUND: There is an ethical imperative to offer the results of trials to those who participated. Existing research highlights that less than a third of trials do so, despite the desire of participants to receive the results of the trials they participated in. This scoping review aimed to identify, collate, and describe the available evidence relating to any aspect of disseminating trial results to participants. METHODS: A scoping review was conducted employing a search of key databases (MEDLINE, EMBASE, PsycINFO, and the Cumulative Index to Nursing & Allied Health Literature (CINAHL) from January 2008 to August 2019) to identify studies that had explored any aspect of disseminating results to trial participants. The search strategy was based on that of a linked existing review. The evidence identified describes the characteristics of included studies using narrative description informed by analysis of relevant data using descriptive statistics. RESULTS: Thirty-three eligible studies, including 12,700 participants (which included patients, health care professionals, trial teams), were identified and included. Reporting of participant characteristics (age, gender, ethnicity) across the studies was poor. The majority of studies investigated dissemination of aggregate trial results. The most frequently reported mode of disseminating of results was postal. Overall, the results report that participants evaluated receipt of trial results positively, with reported benefits including improved communication, demonstration of appreciation, improved retention, and engagement in future research. However, there were also some concerns about how well the dissemination was resourced and done, worries about emotional effects on participants especially when reporting unfavourable results, and frustration about the delay between the end of the trial and receipt of results. CONCLUSIONS: This scoping review has highlighted that few high-quality evaluative studies have been conducted that can provide evidence on the best ways to deliver results to trial participants. There have been relatively few qualitative studies that explore perspectives from diverse populations, and those that have been conducted are limited to a handful of clinical areas. The learning from these studies can be used as a platform for further research and to consider some core guiding principles of the opportunities and challenges when disseminating trial results to those who participated.

Interprofessional simulation training for community mental health teams: Findings from a mixed methods study.

Community mental health teams (CMHTs) in England face mounting service pressures due to an increased focus on out-of-hospital care. Interprofessional working is essential to providing good mental healthcare in community settings. Simulation training is underused in mental health, despite strong support for its improvement of clinical skills, confidence, teamwork, and interprofessional collaboration in other healthcare settings. This study aims to evaluate the impact of simulation training on community mental health professionals. An interprofessional simulation training course on assessment and team working skills for community mental health professionals was developed and delivered at a time of service reorganisation in South London services, including changes to job roles and responsibilities. In total, 57 course participants completed a survey that measured perceptions of knowledge and confidence, as well as a general view of the course. Eight participants took part in further semi-structured interviews 2-3 months after the course to provide perceptions about this experience's subsequent impact. There were statistically significant increases in knowledge and confidence scores with large effect sizes. Thematic analyses of open-text survey and interview data identified emergent themes of interprofessional understanding; attitudes in clinical practice; staff well-being; the value of reflection; opportunity for feedback; and fidelity to clinical practice. Simulation training can improve confidence and knowledge in core skills and team working for CMHTs. Participants reported benefits to key areas of community mental healthcare, such as interprofessional collaboration, reflective practice, and staff well-being. Findings represented individual and team learning, as well as subsequent changes to clinical practice, and were related back to the interactive and reflective nature of the simulation. Implications are highlighted concerning the use of interprofessional simulation training in mental health, particularly relating to staff well-being, attitudes, and interprofessional working.

Measurement properties of quality of life measurement instruments for infants, children and adolescents with eczema: protocol for a systematic review.

BACKGROUND: Eczema is a common chronic or chronically relapsing, inflammatory skin disease that exerts a substantial negative impact on quality of life (QoL). The Harmonising Outcome Measures for Eczema (HOME) initiative has used a consensus-based process which identified QoL as one of the four core outcome domains to be assessed in all eczema clinical trials. A number of measurement instruments exist to measure QoL in infants, children, and adolescents with eczema, and there is a great variability in both content and quality of the instruments used. Therefore, the objective of the proposed research is to comprehensively and systematically assess the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in infants, children, and adolescents with eczema. METHODS/DESIGN: This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for infants, children, and adolescents with eczema. A systematic literature search will be carried out in MEDLINE via PubMed and EMBASE using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for infants, children, and adolescents with eczema. Two reviewers will independently perform eligibility assessment and data abstraction. Evidence tables will be used to record study characteristics, instrument characteristics, measurement properties, and interpretability. The adequacy of the measurement properties will be assessed using predefined criteria. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist will be used to evaluate the methodological quality of included studies. A best evidence synthesis will be undertaken if more than one study has examined a particular measurement property. DISCUSSION: The proposed systematic review will yield a comprehensive assessment of measurement properties of existing QoL instruments in infants, children, and adolescents with eczema. The results will serve as a basis to recommend a QoL measurement instrument for infants, one for children, and one for adolescents for use in future clinical trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015023483.

Measurement properties of adult quality-of-life measurement instruments for eczema: protocol for a systematic review.

BACKGROUND: Eczema is a common chronic or chronically relapsing skin disease that has a substantial impact on quality of life (QoL). By means of a consensus-based process, the Harmonising Outcome Measures in Eczema (HOME) initiative has identified QoL as one of the four core outcome domains to be assessed in all eczema trials (Allergy 67(9):1111-7, 2012). Various measurement instruments exist to measure QoL in adults with eczema, but there is a great variability in both content and quality (for example, reliability and validity) of the instruments used, and it is not always clear if the best instrument is being used. Therefore, the aim of the proposed research is a comprehensive systematic assessment of the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in adults with eczema. METHODS/DESIGN: This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for adults with eczema. Medline via PubMed and EMBASE will be searched using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for adult patients with eczema. Eligibility assessment and data abstraction will be performed independently by two reviewers. Evidence tables will be generated for study characteristics, instrument characteristics, measurement properties, and interpretability. The quality of the measurement properties will be assessed using predefined criteria. Methodological quality of studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best evidence synthesis will be undertaken if more than one study has investigated a particular measurement property. DISCUSSION: The proposed systematic review will produce a comprehensive assessment of measurement properties of existing QoL instruments in adult patients with eczema. We aim to identify one best currently available instrument to measure QoL in eczema patients. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015017138.

Oral evening primrose oil and borage oil for eczema.

BACKGROUND: Eczema is a chronic inflammatory skin condition, which usually develops in early childhood. Many children outgrow this disorder as they reach secondary school age, and although It may improve with age, there is no cure. Constant itch makes life uncomfortable for those with this condition, no matter what age they are, so it may have a significant effect on a person's quality of life. Its prevalence seems to be increasing as populations move from rural locations to cities. Some people, who do not see an adequate improvement or fear side-effects of conventional medical products, try complementary alternatives to conventional treatment. This is a review of evening primrose oil (EPO) and borage oil (BO) taken orally (by mouth); these have been thought to be beneficial because of their gamma-linolenic acid content. OBJECTIVES: To assess the effects of oral evening primrose oil or borage oil for treating the symptoms of atopic eczema. SEARCH METHODS: We searched the following databases up to August 2012: Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE (from 1946), EMBASE (from 1974), AMED (from 1985), and LILACS (from 1982). We also searched online trials registers and checked the bibliographies of included studies for further references to relevant trials. We corresponded with trial investigators and pharmaceutical companies to try to identify unpublished and ongoing trials. We performed a separate search for adverse effects of evening primrose oil and borage oil in November 2011. SELECTION CRITERIA: All randomised controlled, parallel, or cross-over trials investigating oral intake of evening primrose oil or borage oil for eczema. DATA COLLECTION AND ANALYSIS: Two review authors independently applied eligibility criteria, assessed risk of bias, and extracted data. We pooled dichotomous outcomes using risk ratios (RR), and continuous outcomes using the mean difference (MD). Where possible, we pooled study results using random-effects meta-analysis and tested statistical heterogeneity using both the Chi(²) test and the I(²) statistic test. We presented results using forest plots with 95% confidence intervals (CI). MAIN RESULTS: A total of 27 studies (1596 participants) met the inclusion criteria: 19 studies assessed evening primrose oil, and 8 studies assessed borage oil. For EPO, a meta-analysis of results from 7 studies showed that EPO failed to significantly increase improvement in global eczema symptoms as reported by participants on a visual analogue scale of 0 to 100 (MD -2.22, 95% CI -10.48 to 6.04, 176 participants, 7 trials) and a visual analogue scale of 0 to 100 for medical doctors (MD -3.26, 95% CI -6.96 to 0.45, 289 participants, 8 trials) compared to the placebo group.Treatment with BO also failed to significantly improve global eczema symptoms compared to placebo treatment as reported by both participants and medical doctors, although we could not conduct a meta-analysis as studies reported results in different ways. With regard to the risk of bias, the majority of studies were of low risk of bias; we judged 67% of the included studies as having low risk of bias for random sequence generation; 44%, for allocation concealment; 59%, for blinding; and 37%, for other biases. IMPLICATIONS FOR PRACTICE: Oral borage oil and evening primrose oil lack effect on eczema; improvement was similar to respective placebos used in trials. Oral BO and EPO are not effective treatments for eczema.In these studies, along with the placebos, EPO and BO have the same, fairly common, mild, transient adverse effects, which are mainly gastrointestinal.The short-term studies included here do not examine possible adverse effects of long-term use of EPO or BO. A case report warned that if EPO is taken for a prolonged period of time (more than one year), there is a potential risk of inflammation, thrombosis, and immunosuppression; another study found that EPO may increase bleeding for people on Coumadin® (warfarin) medication. IMPLICATIONS FOR RESEARCH: Noting that the confidence intervals between active and placebo treatment are narrow, to exclude the possibility of any clinically useful difference, we concluded that further studies on EPO or BO for eczema would be hard to justify.This review does not provide information about long-term use of these products.

Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting.

The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research.

Dietary supplements for established atopic eczema.

BACKGROUND: Many people with atopic eczema are reluctant to use the most commonly recommended treatments because they fear the long-term health effects. As a result, many turn to dietary supplements as a possible treatment approach, often with the belief that some essential ingredient is 'missing' in their diet. Various supplements have been proposed, but it is unclear whether any of these interventions are effective. OBJECTIVES: To evaluate dietary supplements for treating established atopic eczema/dermatitis.Evening primrose oil, borage oil, and probiotics are covered in other Cochrane reviews. SEARCH METHODS: We searched the following databases up to July 2010: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE (from 2005), EMBASE (from 2007), PsycINFO (from 1806), AMED (from 1985), LILACS (from 1982), ISI Web of Science, GREAT (Global Resource of EczemA Trials) database, and reference lists of articles. We searched ongoing trials registers up to April 2011. SELECTION CRITERIA: Randomised controlled trials (RCTs) of dietary supplements for the treatment of those with established atopic eczema/dermatitis. DATA COLLECTION AND ANALYSIS: Two authors independently screened the titles and abstracts, read the full text of the publications, extracted data, and assessed the risk of bias. MAIN RESULTS: We included 11 studies with a total of 596 participants. Two studies assessed fish oil versus olive oil or corn oil placebo. The following were all looked at in single studies: oral zinc sulphate compared to placebo, selenium versus selenium plus vitamin E versus placebo, vitamin D versus placebo, vitamin D versus vitamin E versus vitamins D plus vitamin E together versus placebo, pyridoxine versus placebo, sea buckthorn seed oil versus sea buckthorn pulp oil versus placebo, hempseed oil versus placebo, sunflower oil (linoleic acid) versus fish oil versus placebo, and DHA versus control (saturated fatty acids of the same energy value). Two small studies on fish oil suggest a possible modest benefit, but many outcomes were explored. A convincingly positive result from a much larger study with a publicly-registered protocol is needed before clinical practice can be influenced. AUTHORS' CONCLUSIONS: There is no convincing evidence of the benefit of dietary supplements in eczema, and they cannot be recommended for the public or for clinical practice at present. Whilst some may argue that at least supplements do not do any harm, high doses of vitamin D may give rise to serious medical problems, and the cost of long-term supplements may also mount up.

Prevalence, course and associations of desire for hastened death in a UK palliative population: a cross-sectional study.

OBJECTIVES: To determine the prevalence, severity and remission of desire for hastened death (DHD) in a UK representative sample of patients with advanced disease receiving palliative care and to examine the associations of desire for death. DESIGN: A cross-sectional survey with 4-week follow-up. SETTING: St Christopher's Hospice, Sydenham, South London, which is a large hospice with homecare, outpatient and inpatient facilities serving five London boroughs. PARTICIPANTS: 300 patients newly referred to the hospice for palliative care. MAIN OUTCOME MEASURES: The Desire for Death Rating Scale (DDRS). RESULTS: At T1 33/300 (11%) reported DHD and 11/300 (3.7%) had more serious or pervasive DHD. Of those who expressed DHD at T1 and were interviewed at both time points, 35% no longer reported these thoughts. Of those who reported no DHD at T1, 8% reported DHD at T2. The majority of those who had more severe DHD at T1 had a reduced DHD score by T2. Factors associated with T1 DHD included presence of non-malignant disease, depression, more severe physical symptoms, hopelessness and perceived loss of dignity. CONCLUSIONS: The prevalence of DHD was at the lower end of that seen in previous studies using similar samples. More severe DHD was uncommon and for most part remitted to some extent during the study. The provision of symptom control and timely detection and intervention for depression coupled with a focus on optimising function, instilling hope and preserving dignity are likely to contribute to alleviation of DHD in patients with advanced illness.