Living with an artificial eye: qualitative insights into patient and family member experiences.

PURPOSE: Artificial eye users (AEUs) can experience a negative impact on psychological and emotional wellbeing, including reduced social functioning, which may be a consequence of living with one eye removed, and/or of having a prosthetic eye. This may have wider consequences for their families. We aimed to explore what it means to live with a prosthetic eye, for both AEUs and their families-and how any quality of life (QoL) issues impact on their day-to-day functioning. METHODS: A subset of AEUs and their family members taking part in a feasibility randomised controlled trial comparing hand-painted to digitally printed artificial eyes were invited for semi-structured interviews. Transcripts were analysed using reflexive thematic analysis. Qualitative results related to trial participation are covered elsewhere. Here, we focus on QoL and day-to-day functioning. RESULTS: Twelve AEUs (eight males) and five spouses (one male) who had worn artificial eyes for 2-65 years took part, and four themes were identified. (1) Impact on day-to-day life: AEUs and their spouses have to adapt to (partial) sight loss, reduced levels of confidence, and social withdrawal. (2) Impact on psychological and emotional wellbeing: distress among AEUs and their spouses can be severe and prolonged, highlight unmet support needs. (3) Challenges with treatment experiences: AEUs experienced negative impact of fragmentation of care and long waiting times. (4) Worries about the future: AEUs mentioned fragility of remaining sight, and concerns around potential need for further treatment. CONCLUSION: Patients and their family members experience negative impact of being an AEU on their everyday lives and quality of life. There is a potential role for psychosocial support services in supporting AEUs and their families even long after eye loss.

ADAPTA: A pilot randomised controlled trial of an alcohol-focused intervention versus a healthy living intervention for problem drinkers identified in a general hospital setting.

AIM: To examine the relative feasibility, acceptability, applicability, effectiveness and explore cost-effectiveness of a healthy living focused intervention (HL) compared to an alcohol-focused intervention (AF) for problem drinkers identified in hospital. METHODS: A pragmatic, randomised, controlled, open pilot trial. Feasibility and acceptability were measured by recruitment, attrition, follow-up rates and number of treatment sessions attended. Effectiveness was measured using the Alcohol Use Disorders Identification Test score at six months. Additional economic and secondary outcome measures were collected. RESULTS: Eighty-six participants were randomised and 72% (n=62) were retained in full participation. Forty-one participants attended at least one treatment session (48%). A greater proportion in the HL group attended all four treatment sessions (33% vs 19%). Follow-up rates were 29% at six months and 22% at twelve months. There was no evidence of a difference in AUDIT score between treatment groups at six months. Mean cost of health care and social services, policing and the criminal justice system use decreased while EQ-5D scores indicated minor improvement in both arms. However, this pilot trial was not powered to detect differences in either measure between groups. CONCLUSIONS: While no treatment effect was observed, this study demonstrated a potential to engage patients drinking at harmful or dependent levels in a healthy living intervention. However, recruitment proved challenging and follow-up rates were poor. Better ways need to be found to help these patients recognise the harms associated with their drinking and overcome the evident barriers to their engagement with specialist treatment.

Interventions for reducing alcohol consumption among general hospital inpatient heavy alcohol users: a systematic review.

BACKGROUND: There is growing interest in pro-active detection and provision of interventions for heavy alcohol use in the general hospital inpatient population. We aimed to determine, from the available evidence, the effectiveness of interventions in reducing alcohol consumption among general hospital inpatient heavy alcohol users. METHODS: The following databases were searched for completed and on-going randomised and non-randomised controlled studies published up to November 2012: MEDLINE; C2-SPECTR; CINAHL; The Cochrane Library; Conference Proceedings Citation Index: Science; EMBASE; HMIC; PsycInfo; Public Health Interventions Cost Effectiveness Database (PHICED); and ClinicalTrials.gov. Studies were screened independently by two reviewers. Data extraction was performed by one reviewer and independently checked by a second. RESULTS: Twenty-two studies which met the inclusion criteria enrolled 5307 participants in total. All interventions were non-pharmacological and alcohol focused. Results from single session brief interventions and self-help literature showed no clear benefit on alcohol consumption outcomes, with indications of benefit from some studies but not others. However, results suggest brief interventions of more than one session could be beneficial on reducing alcohol consumption, especially for non-dependent patients. No active intervention was found superior over another on alcohol consumption and other outcomes. CONCLUSIONS: Brief interventions of more than one session could be beneficial on reducing alcohol consumption among hospital inpatients, especially for non-dependent patients. However, additional evidence is still needed before more definitive conclusions can be reached.

Interventions for alcohol and drug problems in outpatient settings: a systematic review.

ISSUES: Research evidence indicates a high prevalence of substance abuse among patients presenting in general hospital settings. Such misuse of alcohol and illicit drugs has a major impact on population health and on costs to health services and to society at large. This review aimed to identify the interventions for alcohol or illicit drug misuse problems that have been evaluated for hospital outpatient populations. APPROACH: Thirteen electronic databases including MEDLINE, EMBASE and PsycInfo were searched for published and unpublished studies in any language up to August 2011. Reference lists of included studies and reviews were also hand-searched. We included randomised and controlled clinical trials of any intervention for adult participants identified as having alcohol and/or drug problems presenting to hospital outpatient settings other than addiction or psychiatric units. Participants could be attending hospital for any reason other than treatment for substance abuse. A narrative synthesis was conducted. KEY FINDINGS: There is some evidence to suggest that interventions based on motivational techniques might be effective in treatment of alcohol misuse in oral-maxillofacial clinics but not in general outpatient departments. The evidence is insufficient to allow any conclusions to be derived on the effectiveness of interventions in the treatment of drug misuse and combined alcohol-drug misuse in outpatient settings. CONCLUSIONS: Further research is needed to investigate interventions for alcohol and drug misuse in outpatient settings. Additionally, problems remain in terms of study quality. Procedures to ensure the rigour of a study were often poorly reported.

Use of weekly, low dose, high frequency ultrasound for hard to heal venous leg ulcers: the VenUS III randomised controlled trial.

OBJECTIVE: To assess the clinical effectiveness of weekly delivery of low dose, high frequency therapeutic ultrasound in conjunction with standard care for hard to heal venous leg ulcers. DESIGN: Multicentre, pragmatic, two arm randomised controlled trial. SETTING: Community and district nurse led services, community leg ulcer clinics, and hospital outpatient leg ulcer clinics in 12 urban and rural settings (11 in the United Kingdom and one in the Republic of Ireland). PARTICIPANTS: 337 patients with at least one venous leg ulcer of >6 months' duration or >5 cm(2) area and an ankle brachial pressure index of ≥ 0.8. INTERVENTIONS: Weekly administration of low dose, high frequency ultrasound therapy (0.5 W/cm(2), 1 MHz, pulsed pattern of 1:4) for up to 12 weeks plus standard care compared with standard care alone. MAIN OUTCOME MEASURES: Primary outcome was time to healing of the largest eligible leg ulcer. Secondary outcomes were proportion of patients healed by 12 months, percentage and absolute change in ulcer size, proportion of time participants were ulcer-free, health related quality of life, and adverse events. RESULTS: The two groups showed no significant difference in the time to healing of the reference leg ulcer (log rank test, P=0.61). After adjustment for baseline ulcer area, baseline ulcer duration, use of compression bandaging, and study centre, there was still no evidence of a difference in time to healing (hazard ratio 0.99 (95% confidence interval 0.70 to 1.40), P=0.97). The median time to healing of the reference leg ulcer was inestimable. There was no significant difference between groups in the proportion of participants with all ulcers healed by 12 months (72/168 in ultrasound group v 78/169 in standard care group, P=0.39 for Fisher's exact test) nor in the change in ulcer size at four weeks by treatment group (model estimate 0.05 (95% CI -0.09 to 0.19)). There was no difference in time to complete healing of all ulcers (log rank test, P=0.61), with median time to healing of 328 days (95% CI 235 to inestimable) with standard care and 365 days (224 days to inestimable) with ultrasound. There was no evidence of a difference in rates of recurrence of healed ulcers (17/31 with ultrasound v 14/31 with standard care, P=0.68 for Fisher's exact test). There was no difference between the two groups in health related quality of life, both for the physical component score (model estimate 0.69 (-1.79 to 3.08)) and the mental component score (model estimate -0.93 (-3.30 to 1.44)), but there were significantly more adverse events in the ultrasound group (model estimate 0.30 (0.01 to 0.60)). There was a significant relation between time to ulcer healing and baseline ulcer area (hazard ratio 0.64 (0.55 to 0.75)) and baseline ulcer duration (hazard ratio 0.59 (0.50 to 0.71)), with larger and older ulcers taking longer to heal. In addition, those centres with high recruitment rates had the highest healing rates. CONCLUSIONS: Low dose, high frequency ultrasound administered weekly for 12 weeks during dressing changes in addition to standard care did not increase ulcer healing rates, affect quality of life, or reduce ulcer recurrence. Trial registration ISRCTN21175670 and National Research Register N0484162339.

Increasing recruitment to randomised trials: a review of randomised controlled trials.

BACKGROUND: Poor recruitment to randomised controlled trials (RCTs) is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective. METHODS: We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies) were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors. RESULTS: We identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive. CONCLUSION: Few trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.