'My sexual desires, everything, my normal life just stops'; a qualitative study of male sexual health in inflammatory bowel disease.

AIM: To describe and interpret the sexual health experiences of men with IBD. DESIGN: Interpretive qualitative study. METHODS: In-depth, semi-structured interviews were conducted with 22 men with a diagnosis of Inflammatory Bowel Disease. Interviews were digitally audio-recorded and transcribed verbatim. Data were analysed using constant comparative, thematic analysis. RESULTS: Three themes were identified from interview data: (1) the disease shapes intimate connections, (2) the disease thwarts sexual experiences and (3) the disease disrupts male gender norms. Men reported that active disease lowered libido and could change pre-, inter- and post-coital sexual practices. All participants noted that health professionals did not initiate the discussion of sexual health and well-being needs in the outpatient hospital setting. Men who engaged in receptive anal sex reported a lack of disease-specific guidance and understanding from professionals. CONCLUSION: Inflammatory bowel disease can negatively impact the sexual well-being, gender identity and activities of men. Further research is required to identify the care preferences of men with IBD and clarify the barriers and facilitators to sexual health assessment so that nurses may better support the health needs of this population. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: This study highlights the need for sexual health and well-being support that is specific to disease and gender in IBD. There is a paucity of information and guidance for men with peri-anal disease and proctitis who engage in receptive anal sex, which requires urgent attention. REPORTING METHOD: Reporting follows the COREQ checklist. PATIENT OR PUBLIC CONTRIBUTION: A patient and public involvement group informed the development of the study design. The group reviewed public facing documents and interview guides. One member of the group provided comments on the identified themes.

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of 'studies within a trial' (SWATs).

BACKGROUND: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed 'Studies Within A Trial' (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment. METHODS: Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part. RESULTS: Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p-value = 0.671, I2 = 0%). There was no effect on any other outcomes. CONCLUSIONS: Multimedia alongside written information did not improve trial recruitment rates. TRIAL REGISTRATION: ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.

Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs.

BACKGROUND: Randomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial participation is usually provided as printed participant information sheets (PIS), which are often long, technical, and unappealing. Multimedia information (MMI), including animations and videos, may be a valuable alternative or complement to a PIS. The Trials Engagement in Children and Adolescents (TRECA) study compared MMI to PIS to investigate the effects on participant recruitment, retention, and quality of decision-making. METHODS: We undertook six SWATs (Study Within A Trial) within a series of host trials recruiting children and young people. Potential participants in the host trials were randomly allocated to receive MMI-only, PIS-only, or combined MMI + PIS. We recorded the rates of recruitment and retention (varying between 6 and 26 weeks post-randomisation) in each host trial. Potential participants approached about each host trial were asked to complete a nine-item Decision-Making Questionnaire (DMQ) to indicate their evaluation of the information and their reasons for participation/non-participation. Odds ratios were calculated and combined in a meta-analysis. RESULTS: Data from 3/6 SWATs for which it was possible were combined in a meta-analysis (n = 1758). Potential participants allocated to MMI-only were more likely to be recruited to the host trial than those allocated to PIS-only (OR 1.54; 95% CI 1.05, 2.28; p = 0.03). Those allocated to combined MMI + PIS compared to PIS-only were no more likely to be recruited to the host trial (OR = 0.89; 95% CI 0.53, 1.50; p = 0.67). Providing MMI rather than PIS did not impact on DMQ scores. Once children and young people had been recruited to host trials, their trial retention rates did not differ according to intervention allocation. CONCLUSIONS: Providing MMI-only increased the trial recruitment rate compared to PIS-only but did not affect DMQ scores. Combined MMI + PIS instead of PIS had no effect on recruitment or retention. MMIs are a useful tool for trial recruitment in children and young people, and they could reduce trial recruitment periods.

Risk factors for initial appointment non-attendance at Improving Access to Psychological Therapy (IAPT) services: A retrospective analysis.

BACKGROUND: Approximately 1.5 million referrals are made to Improving Access to Psychological Therapy (IAPT) services annually. However, treatment is received in less than half of cases due to ineligibility or non-attendance. The aim was to explore risk factors for non-attendance at the initial two IAPT appointments following referral. METHODS: An exploratory, retrospective analysis of referral and attendance data from five IAPT services in the North of England. Participants were 97,020 referrals received 2010-2014. Main outcome was attendance at the first two offered appointments (assessment and initial treatment). RESULTS: Based on data from two services, 66% of referrals resulted in assessment attendance. Across all five services 57% of patients who attended for assessment subsequently attended the first treatment appointment. The odds of attending an assessment appointment were more than 3 times higher for self-referrals than for GP referrals (OR 3.46, 95% CI 3.27-3.66, p < 0.001). Factors important to treatment appointment attendance following assessment were the service, referral source, presenting problem, and anxiety severity. CONCLUSION: Initial appointment non-attendance is a consistent problem for IAPT services. Specific factors that may support IAPT services to improve non-attendance rates are identified. IAPT indicators of success should take account of non-attendance at initial appointments.

The importance of cancer prevention policies to inform and guide preventative and screening measures for people with intellectual disabilities: The COST project "Cancer- Understanding Prevention in Intellectual Disabilities".

Cancer is a global public health problem, but its exact prevalence in people with intellectual disabilities is still uncertain. This population, with limited health skills and complex health needs, faces many challenges in cancer prevention, screening, timely diagnosis and treatment. Furthermore, they are often underrepresented in general cancer prevention and screening policies across Europe, leading to widened disparities in health outcomes and premature mortality. Thus, unified national and local policies are needed to reduce inequalities and promoting a pan-European inclusion of people with intellectual disabilities. Our goal is to raise public awareness of this issue, including the involvement of people with intellectual disabilities, and promote engagement from relevant stakeholders. The COST Action 'Cancer- Understanding Prevention in Intellectual Disabilities' (CUPID) project will address health inequalities faced by people with intellectual disabilities in relation to cancer, and support the development of policy recommendations specifically tailored to their unique cognitive and healthcare needs, having a positive long-term impact on quality of life.

Dynamics and outcomes of binary collisions of equi-diameter picolitre droplets with identical viscosities.

The dynamics of binary collisions of equi-diameter picolitre droplets with identical viscosities, varying impact speeds and impact angles have been investigated experimentally and compared to collision outcome prediction models. Collisions between pairs of pure water droplets with a viscosity of 0.89 mPa s and pairs of aqueous-sucrose (40% w/w) droplets with a viscosity of 5.17 mPa s were examined. The colliding droplets were ∼38 µm in diameter, which is around ten times smaller than those previously investigated when examining the effect of viscosity on the outcome of binary droplet collisions. Varying the impact speed and angle resulted in different collision outcomes, including coalescence, reflexive separation and stretching separation. The collision outcomes were plotted on two viscosity dependent regime maps. The regime boundaries are generally in agreement with earlier literature for both high and low viscosity cases. The agreement between experiment and theory, for both fluids, gives more confidence in the models tested here to predict collision outcomes for droplets of this size and these viscosities.

Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.

BACKGROUND: The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded 'studies within a trial' (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment. METHODS: Seven 'host' trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part. RESULTS: Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I2 = 0%). CONCLUSIONS: Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies. TRIAL REGISTRATION: Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).

Information provision for stroke survivors and their carers.

BACKGROUND: A stroke is a sudden loss of brain function caused by lack of blood supply. Stroke can lead to death or physical and cognitive impairment and can have long lasting psychological and social implications. Research shows that stroke survivors and their families are dissatisfied with the information provided and have a poor understanding of stroke and associated issues. OBJECTIVES: The primary objective is to assess the effects of active or passive information provision for stroke survivors (people with a clinical diagnosis of stroke or transient ischaemic attack (TIA)) or their identified carers. The primary outcomes are knowledge about stroke and stroke services, and anxiety. SEARCH METHODS: We updated our searches of the Cochrane Stroke Group Specialised Register on 28 September 2020 and for the following databases to May/June 2019: the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 5) and the Cochrane Database of Systematic Reviews (CDSR; 2019, Issue 5) in the Cochrane Library (searched 31 May 2019), MEDLINE Ovid (searched 2005 to May week 4, 2019), Embase Ovid (searched 2005 to 29 May 2019), CINAHL EBSCO (searched 2005 to 6 June 2019), and five others. We searched seven study registers and checked reference lists of reviews. SELECTION CRITERIA: Randomised trials involving stroke survivors, their identified carers or both, where an information intervention was compared with standard care, or where information and another therapy were compared with the other therapy alone, or where the comparison was between active and passive information provision without other differences in treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility and risk of bias, and extracted data. We categorised interventions as either active information provision or passive information provision: active information provision included active participation with subsequent opportunities for clarification and reinforcement; passive information provision provided no systematic follow-up or reinforcement procedure. We stratified analyses by this categorisation. We used GRADE methods to assess the overall certainty of the evidence. MAIN RESULTS: We have added 12 new studies in this update. This review now includes 33 studies involving 5255 stroke-survivor and 3134 carer participants. Twenty-two trials evaluated active information provision interventions and 11 trials evaluated passive information provision interventions. Most trials were at high risk of bias due to lack of blinding of participants, personnel, and outcome assessors where outcomes were self-reported. Fewer than half of studies were at low risk of bias regarding random sequence generation, concealment of allocation, incomplete outcome data or selective reporting. The following estimates have low certainty, based on the quality of evidence, unless stated otherwise. Accounting for certainty and size of effect, analyses suggested that for stroke survivors, active information provision may improve stroke-related knowledge (standardised mean difference (SMD) 0.41, 95% confidence interval (CI) 0.17 to 0.65; 3 studies, 275 participants), may reduce cases of anxiety and depression slightly (anxiety risk ratio (RR) 0.85, 95% CI 0.68 to 1.06; 5 studies, 1132 participants; depression RR 0.83, 95% CI 0.68 to 1.01; 6 studies, 1315 participants), may reduce Hospital Anxiety and Depression Scale (HADS) anxiety score slightly, (mean difference (MD) -0.73, 95% CI -1.10 to -0.36; 6 studies, 1171 participants), probably reduces HADS depression score slightly (MD (rescaled from SMD) -0.8, 95% CI -1.27 to -0.34; 8 studies, 1405 participants; moderate-certainty evidence), and may improve each domain of the World Health Organization Quality of Life assessment short-form (WHOQOL-BREF) (physical, MD 11.5, 95% CI 7.81 to 15.27; psychological, MD 11.8, 95% CI 7.29 to 16.29; social, MD 5.8, 95% CI 0.84 to 10.84; environment, MD 7.0, 95% CI 3.00 to 10.94; 1 study, 60 participants). No studies evaluated positive mental well-being. For carers, active information provision may reduce HADS anxiety and depression scores slightly (MD for anxiety -0.40, 95% CI -1.51 to 0.70; 3 studies, 921 participants; MD for depression -0.30, 95% CI -1.53 to 0.92; 3 studies, 924 participants), may result in little to no difference in positive mental well-being assessed with Bradley's well-being questionnaire (MD -0.18, 95% CI -1.34 to 0.98; 1 study, 91 participants) and may result in little to no difference in quality of life assessed with a 0 to 100 visual analogue scale (MD 1.22, 95% CI -7.65 to 10.09; 1 study, 91 participants). The evidence is very uncertain (very low certainty) for the effects of active information provision on carers' stroke-related knowledge, and cases of anxiety and depression. For stroke survivors, passive information provision may slightly increase HADS anxiety and depression scores (MD for anxiety 0.67, 95% CI -0.37 to 1.71; MD for depression 0.39, 95% CI -0.61 to 1.38; 3 studies, 227 participants) and the evidence is very uncertain for the effects on stroke-related knowledge, quality of life, and cases of anxiety and depression. For carers, the evidence is very uncertain for the effects of passive information provision on stroke-related knowledge, and HADS anxiety and depression scores. No studies of passive information provision measured carer quality of life, or stroke-survivor or carer positive mental well-being. AUTHORS' CONCLUSIONS: Active information provision may improve stroke-survivor knowledge and quality of life, and may reduce anxiety and depression. However, the reductions in anxiety and depression scores were small and may not be important. In contrast, providing information passively may slightly worsen stroke-survivor anxiety and depression scores, although again the importance of this is unclear. Evidence relating to carers and to other outcomes of passive information provision is generally very uncertain. Although the best way to provide information is still unclear, the evidence is better for strategies that actively involve stroke survivors and carers and include planned follow-up for clarification and reinforcement.

Evaluating the use of multimedia information when recruiting adolescents to orthodontics research: A randomised controlled trial.

OBJECTIVE: To compare two methods of providing information about the Bone Anchored Maxillary Protraction (BAMP) trial: standard printed information and multimedia websites, for their quality and ease of understanding, and impact on decision-making. DESIGN: Randomised controlled trial. SETTING: Orthodontic outpatient clinic in the UK. METHODS: Participants were 109 adolescents (aged 11-14 years) attending for orthodontic treatment. While awaiting treatment they were asked to imagine being recruited to the BAMP clinical trial. They were individually randomised to receive the printed or the multimedia website information (comprising text, animations and 'talking head' videos). After reading or viewing the information, they completed a 9-item Likert scale Decision-Making Questionnaire (DMQ) (score range 0-36) plus three free-text questions on their evaluation of the information. RESULTS: A total of 104 participants completed the questionnaire. Mean total DMQ scores were higher (more positive) in the website group (28.1 vs. 27.0), although the difference was small and not statistically significant (P = 0.20). Analysis of individual questionnaire items showed two statistically significant differences: the website information had higher ratings on 'easy to understand' (Z = 3.03; P = 0.003) and 'confidence in decision-making' (Z = 2.00; P = 0.044). On the three free-text questions, more positive and fewer negative comments were made about the websites than the printed information. CONCLUSION: In this hypothetical trial setting, adolescent patients found that trial information conveyed on a multimedia website was easier to understand and made them more confident in their decision about trial participation. Their subjective evaluations of the website were also more positive and less negative than about the printed information. Multimedia information has the potential to increase the quality of engagement and information exchange when seeking consent for research.

Rehabilitation strategies following oesophagogastric and Hepatopancreaticobiliary cancer (ReStOre II): a protocol for a randomized controlled trial.

BACKGROUND: Curative treatment for upper gastrointestinal (UGI) and hepatopancreaticobiliary (HPB) cancers, involves complex surgical resection often in combination with neoadjuvant/adjuvant chemo/chemoradiotherapy. With advancing survival rates, there is an emergent cohort of UGI and HPB cancer survivors with physical and nutritional deficits, resultant from both the cancer and its treatments. Therefore, rehabilitation to counteract these impairments is required to maximise health related quality of life (HRQOL) in survivorship. The initial feasibility of a multidisciplinary rehabilitation programme for UGI survivors was established in the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) feasibility study and pilot randomised controlled trial (RCT). ReStOre II will now further investigate the efficacy of that programme as it applies to a wider cohort of UGI and HPB cancer survivors, namely survivors of cancer of the oesophagus, stomach, pancreas, and liver. METHODS: The ReStOre II RCT will compare a 12-week multidisciplinary rehabilitation programme of supervised and self-managed exercise, dietary counselling, and education to standard survivorship care in a cohort of UGI and HPB cancer survivors who are > 3-months post-oesophagectomy/ gastrectomy/ pancreaticoduodenectomy, or major liver resection. One hundred twenty participants (60 per study arm) will be recruited to establish a mean increase in the primary outcome (cardiorespiratory fitness) of 3.5 ml/min/kg with 90% power, 5% significance allowing for 20% drop out. Study outcomes of physical function, body composition, nutritional status, HRQOL, and fatigue will be measured at baseline (T0), post-intervention (T1), and 3-months follow-up (T2). At 1-year follow-up (T3), HRQOL alone will be measured. The impact of ReStOre II on well-being will be examined qualitatively with focus groups/interviews (T1, T2). Bio-samples will be collected from T0-T2 to establish a national UGI and HPB cancer survivorship biobank. The cost effectiveness of ReStOre II will also be analysed. DISCUSSION: This RCT will investigate the efficacy of a 12-week multidisciplinary rehabilitation programme for survivors of UGI and HPB cancer compared to standard survivorship care. If effective, ReStOre II will provide an exemplar model of rehabilitation for UGI and HPB cancer survivors. TRIAL REGISTRATION: The study is registered with ClinicalTrials.gov, registration number: NCT03958019, date registered: 21/05/2019.

Electrical Double Layer of Supported Atomically Thin Materials.

The electrical double layer (EDL), consisting of two parallel layers of opposite charges, is foundational to many interfacial phenomena and unique in atomically thin materials. An important but unanswered question is how the "transparency" of atomically thin materials to their substrates influences the formation of the EDL. Here, we report that the EDL of graphene is directly affected by the surface energy of the underlying substrates. Cyclic voltammetry and electrochemical impedance spectroscopy measurements demonstrate that graphene on hydrophobic substrates exhibits an anomalously low EDL capacitance, much lower than what was previously measured for highly oriented pyrolytic graphite, suggesting disturbance of the EDL ("disordered EDL") formation due to the substrate-induced hydrophobicity to graphene. Similarly, electrostatic gating using EDL of graphene field-effect transistors shows much lower transconductance levels or even no gating for graphene on hydrophobic substrates, further supporting our hypothesis. Molecular dynamics simulations show that the EDL structure of graphene on a hydrophobic substrate is disordered, caused by the disruption of water dipole assemblies. Our study advances understanding of EDL in atomically thin limit.

Prevention of mood disorder after stroke: a randomised controlled trial of problem solving therapy versus volunteer support.

BACKGROUND: Mood disorder after stroke is common but drug and psychosocial treatments have been assessed with disappointing results. Preventing mood disorder from developing in the first place could be a better approach and might reduce the need for pharmacotherapy in this predominantly older patient group. We used a brief problem-solving therapy and evaluated its effect in reducing mood disorder in the 12 months after stroke. METHODS: A 3-group, parallel, randomised controlled trial. Four hundred fifty patients with stroke were randomised within 1 month of hospital admission to problem-solving therapy from a psychiatric nurse, non-specific support given by volunteers or treatment-as-usual. Follow up took place at 6 and 12 months after stroke. Standardised measures of mood (Present State Examination, GHQ-28), cognitive state (mini-mental state examination) and function (Barthel ADL index, Frenchay Activities Index) were taken at baseline, 6 and 12 months after randomisation. Satisfaction with care was recorded at follow up. RESULTS: At 6 months, all psychological and activity measures favoured problem-solving therapy. At 12 months, patients in the problem-solving therapy group had significantly lower GHQ-28 scores and lower median Present State Examination symptom scores. There were no statistically significant differences in activity. The problem-solving therapy group were more satisfied with some aspects of care. CONCLUSIONS: The results are encouraging and suggest it is possible to prevent mood disorder in stroke patients using a psychological intervention. The differences between the groups at 12 months may indicate a sustained impact of psychological therapies, by comparison with non-specific support. TRIAL REGISTRATION: ISRCTN: ISRCTN33773710 Registered: 23/01/2004 (Retrospectively).

Interventions for treating anxiety after stroke.

BACKGROUND: Approximately 20% of stroke patients experience clinically significant levels of anxiety at some point after stroke. Physicians can treat these patients with antidepressants or other anxiety-reducing drugs, or both, or they can provide psychological therapy. This review looks at available evidence for these interventions. This is an update of the review first published in October 2011. OBJECTIVES: The primary objective was to assess the effectiveness of pharmaceutical, psychological, complementary, or alternative therapeutic interventions in treating stroke patients with anxiety disorders or symptoms. The secondary objective was to identify whether any of these interventions for anxiety had an effect on quality of life, disability, depression, social participation, caregiver burden, or risk of death. SEARCH METHODS: We searched the trials register of the Cochrane Stroke Group (January 2017). We also searched the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library; 2017, Issue 1: searched January 2017); MEDLINE (1966 to January 2017) in Ovid; Embase (1980 to January 2017) in Ovid; the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1937 to January 2017) in EBSCO; and PsycINFO (1800 to January 2017) in Ovid. We conducted backward citation searches of reviews identified through database searches and forward citation searches of included studies. We contacted researchers known to be involved in related trials, and we searched clinical trials registers for ongoing studies. SELECTION CRITERIA: We included randomised trials including participants with a diagnosis of both stroke and anxiety for which treatment was intended to reduce anxiety. Two review authors independently screened and selected titles and abstracts for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias. We performed a narrative review. We planned to do a meta-analysis but were unable to do so as included studies were not sufficiently comparable. MAIN RESULTS: We included three trials (four interventions) involving 196 participants with stroke and co-morbid anxiety. One trial (described as a 'pilot study') randomised 21 community-dwelling stroke survivors to four-week use of a relaxation CD or to wait list control. This trial assessed anxiety using the Hospital Anxiety and Depression Scale and reported a reduction in anxiety at three months among participants who had used the relaxation CD (mean (standard deviation (SD) 6.9 (± 4.9) and 11.0 (± 3.9)), Cohen's d = 0.926, P value = 0.001; 19 participants analysed).The second trial randomised 81 participants with co-morbid anxiety and depression to paroxetine, paroxetine plus psychotherapy, or standard care. Mean levels of anxiety severity scores based on the Hamilton Anxiety Scale (HAM-A) at follow-up were 5.4 (SD ± 1.7), 3.8 (SD ± 1.8), and 12.8 (SD ± 1.9), respectively (P value < 0.01).The third trial randomised 94 stroke patients, also with co-morbid anxiety and depression, to receive buspirone hydrochloride or standard care. At follow-up, the mean levels of anxiety based on the HAM-A were 6.5 (SD ± 3.1) and 12.6 (SD ± 3.4) in the two groups, respectively, which represents a significant difference (P value < 0.01). Half of the participants receiving paroxetine experienced adverse events that included nausea, vomiting, or dizziness; however, only 14% of those receiving buspirone experienced nausea or palpitations. Trial authors provided no information about the duration of symptoms associated with adverse events. The trial of relaxation therapy reported no adverse events.The quality of the evidence was very low. Each study included a small number of participants, particularly the study of relaxation therapy. Studies of pharmacological agents presented details too limited to allow judgement of selection, performance, and detection bias and lack of placebo treatment in control groups. Although the study of relaxation therapy had allocated participants to treatment using an adequate method of randomisation, study recruitment methods might have introduced bias, and drop-outs in the intervention group may have influenced results. AUTHORS' CONCLUSIONS: Evidence is insufficient to guide the treatment of anxiety after stroke. Further well-conducted randomised controlled trials (using placebo or attention controls) are required to assess pharmacological agents and psychological therapies.

Combined verbal and numerical expressions increase perceived risk of medicine side-effects: a randomized controlled trial of EMA recommendations.

BACKGROUND: The study evaluated European Medicines Agency (EMA) recommendations on communicating frequency information on side-effect risk. METHODS: The study used a 2 × 2 factorial trial, with random allocation of information about 10 side-effects of paclitaxel (Taxol) expressed using one of four formats. Recruitment was via the CancerHelpUK website. Information was conveyed using numerical frequency bands (e.g. 'may affect up to 1 in 10 people') or combined verbal terms and numerical bands (e.g. 'common: may affect up to 1 in 10 people'); in addition, the risk qualifier verb was manipulated, with risks expressed either as 'will affect…' or 'may affect…'. Participants then made six side-effect frequency estimates indicated their satisfaction with the information and evaluated the side-effects: how bad; how likely; how risky to health; and their influence on taking paclitaxel. RESULTS: The sample comprised 339 people, of whom 37.5% had cancer. The combined verbal and numerical risk expressions resulted in higher estimates of side-effects, four of which reached statistical significance (P < 0.05), and participants also said that side-effects would be more likely. Use of 'may affect' or 'will affect' did not result in differences in any estimates. CONCLUSIONS: This is the first evaluation of the full range of combined verbal and numerical risk expressions recommended in EMA guidance; it demonstrates that they can lead to significant risk overestimations when compared to numerical frequency bands alone. The EMA should consider revising its guidance. Government agencies and professional bodies should be cautious about recommendations for risk communication in the absence of empirical evidence.

A systematic review of research into black and ethnic minority patients' views on self-management of type 2 diabetes.

CONTEXT: Eliciting patients' views of type 2 diabetes self-management provides insights on how policy and services might better support the needs of this population. OBJECTIVE: To synthesize black and ethnic minority patients' views on the barriers and facilitators influencing the self-management of type 2 diabetes. SEARCH STRATEGY: A systematic search of international literature published in nine electronic databases was undertaken in 2008. Search strategies used both MeSH and free-text terms. Two relevant journals were also hand searched. INCLUSION CRITERIA: Any primary empirical study published in the English language since 1986 that reported black and ethnic minority patients' views on type 2 diabetes self-management. DATA EXTRACTION AND SYNTHESIS: Data were extracted and study quality was formally assessed. Data were analysed using thematic synthesis. MAIN RESULTS: Fifty-seven studies were included, of qualitative (n = 54), mixed-method (n = 2) or quantitative (n = 1) design. Studies were from North America (n = 41), Europe (n = 14) and Australia (n = 2), including 1735 participants in total. Three analytical themes emerged: 'Importance of identity'; 'Being understood by others' and 'Making sense of condition', all linked conceptually under the overarching theme 'Sense of self'. The quality of the studies varied. DISCUSSION AND CONCLUSIONS: The findings provide insight into what black and minority ethnic people regard as the barriers to, and facilitators of self-management, as opposed to what health professionals, policy makers and trial researchers may have assumed. Recognition of the views of people with diabetes is essential for the design and delivery of patient-centred care and policies.

Rehabilitation for post-stroke cognitive impairment: an overview of recommendations arising from systematic reviews of current evidence.

BACKGROUND: Although cognitive impairments are common following stroke, there is considerable uncertainty about the types of interventions that can reduce activity restrictions and improve quality of life. Indeed, a recent project to identify priorities for research into life after stroke determined that the top priority for patients, carers and health professionals was how to improve cognitive impairments. OBJECTIVE: To provide an overview of the evidence for the effectiveness of cognitive rehabilitation for patients with stroke and to determine the main gaps in the current evidence base. METHODS: Evidence was synthesised for the six Cochrane reviews relating to rehabilitation for post-stroke cognitive impairment and any subsequently published randomized controlled trials to February 2012. RESULTS: Data arising from 44 trials involving over 1500 patients was identified. Though there was support for the effectiveness of cognitive rehabilitation for some cognitive impairments, significant gaps were found in the current evidence base. All of the Cochrane reviews identified major limitations within the evidence they identified. CONCLUSIONS: There is currently insufficient research evidence, or evidence of insufficient quality, to support clear recommendations for clinical practice. Recommendations are made as to the research required to strengthen the evidence base, and so facilitate the delivery of effective interventions to individuals with cognitive impairment after stroke.

British-Pakistani women's perspectives of diabetes self-management: the role of identity.

AIMS AND OBJECTIVES: To explore the effects of type 2 diabetes on British-Pakistani women's identity and its relationship with self-management. BACKGROUND: Type 2 diabetes is more prevalent and has worse outcomes among some ethnic minority groups. This may be due to poorer self-management and an inadequate match of health services to patient needs. The influence that type 2 diabetes has on British-Pakistani women's identity and subsequent self-management has received limited attention. DESIGN: An explorative qualitative study. METHODS: Face-to-face semi-structured English and Urdu language interviews were conducted with a purposively selected heterogeneous sample of 15 British-Pakistani women with type 2 diabetes. Transcripts were analysed thematically. RESULTS: Four themes emerged: Perceived change in self emphasised how British-Pakistani women underwent a conscious adaptation of identity following diagnosis; Familiarity with ill health reflected women's adjustment to their changed identity over time; Diagnosis improves social support enabled women to accept changes within themselves and Supporting family is a barrier to self-management demonstrated how family roles were an aspect of women's identities that was resilient to change. The over-arching theme Role re-alignment enables successful self-management encapsulated how self-management was a continuous process where achievements needed to be sustained. Inter-generational differences were also noted: first generation women talked about challenges associated with ageing and co-morbidities; second generation women talked about familial and work roles competing with self-management. CONCLUSIONS: The complex nature of British-Pakistani women's self-identification requires consideration when planning and delivering healthcare. RELEVANCE TO CLINICAL PRACTICE: Culturally competent practice should recognise how generational status influences self-identity and diabetes self-management in ethnically diverse women. Health professionals should remain mindful of effective self-management occurring alongside, and being influenced by, other aspects of life.

Mixture modelling analysis of one-month disability after stroke: stroke outcomes study (SOS1).

PURPOSE: Understanding the heterogeneity in disability after stroke is important to guide treatment and rehabilitation planning. We explored mixture modelling analysis to identify subgroups of stroke disability and factors associated with disability subgroups. METHOD: Analyses were performed using secondary data from a cohort of 448 stroke patients who participated in a 2-year study of stroke outcomes. Mixture modelling approach was used to determine subgroups of early disability following stroke based on the Barthel Index, General Health Questionnaire (GHQ-28), Frenchay Activities Index and the Nottingham Extended Activities of Daily Living Scale. RESULTS: Five distinct disability groups were identified. Nineteen (4.2%) patients were classified as having very severe disability, 58 (12.9%) severe disability, 133 (29.7%) moderate disability, 198 (44.2%) mild disability and 40 (8.9%) a mood disorder. Compared to the mild group, patients in the "very severe" group were more likely to be elderly and to have had a previous stroke, and less likely to live alone and had a greater risk of mortality 2 years after stroke. Patients in the mood disorder group showed greater dependency in activities of daily living were younger compared to the other groups and had a greater risk of having mood symptoms 2 years after stroke. CONCLUSION: Mixture modelling of 1-month disability after stroke using a broad range of outcome measures has identified clinically meaningful groups relating to long-term outcomes.

Assessing the quality and usability of smartphone apps for pain self-management.

OBJECTIVE: To evaluate smartphone apps intended for self-management of pain using quality assessment criteria and usability testing with prospective users. DESIGN: 1) Survey and content analysis of available apps; and 2) individual usability study of two apps. SETTING: University of Leeds, United Kingdom. PARTICIPANTS: Forty-one participants (aged 19-59 years) with experience of chronic or recurrent pain episodes. METHODS: We undertook a survey, content analysis, and quality appraisal of all currently available mobile phone apps for self-management of pain. Two apps were then selected and assessed with usability testing. RESULTS: Twelve apps met the inclusion criteria. The quality assessment revealed wide variation in their clinical content, interface design, and usability to support self-management of pain. Very little user or clinician involvement was identified in the development of the apps. From the usability testing, participants stated a preference for an interface design employing a lighter color scheme and particular text font. Although very few participants were aware of pain-reporting apps prior to participation, many would consider use in the future. CONCLUSIONS: Variation in app quality and a lack of user and clinician engagement in development were found across the pain apps in this research. Usability testing identified a range of user preferences. Although useful information was obtained, it would be beneficial to involve users earlier in the process of development, as well as establishing ways to merge end user requirements with evidence-based content, to provide high-quality and usable apps for self-management of pain.

Experimental study and analytical model of deformation of magnetostrictive films as applied to mirrors for x-ray space telescopes.

The desire for continuously gaining new knowledge in astronomy has pushed the frontier of engineering methods to deliver lighter, thinner, higher quality mirrors at an affordable cost for use in an x-ray observatory. To address these needs, we have been investigating the application of magnetic smart materials (MSMs) deposited as a thin film on mirror substrates. MSMs have some interesting properties that make the application of MSMs to mirror substrates a promising solution for making the next generation of x-ray telescopes. Due to the ability to hold a shape with an impressed permanent magnetic field, MSMs have the potential to be the method used to make light weight, affordable x-ray telescope mirrors. This paper presents the experimental setup for measuring the deformation of the magnetostrictive bimorph specimens under an applied magnetic field, and the analytical and numerical analysis of the deformation. As a first step in the development of tools to predict deflections, we deposited Terfenol-D on the glass substrates. We then made measurements that were compared with the results from the analytical and numerical analysis. The surface profiles of thin-film specimens were measured under an external magnetic field with white light interferometry (WLI). The analytical model provides good predictions of film deformation behavior under various magnetic field strengths. This work establishes a solid foundation for further research to analyze the full three-dimensional deformation behavior of magnetostrictive thin films.