Ten-year follow-up of a randomised trial of drainage, irrigation and fibrinolytic therapy (DRIFT) in infants with post-haemorrhagic ventricular dilatation.

BACKGROUND: The drainage, irrigation and fibrinolytic therapy (DRIFT) trial, conducted in 2003-6, showed a reduced rate of death or severe disability at 2 years in the DRIFT compared with the standard treatment group, among preterm infants with intraventricular haemorrhage (IVH) and post-haemorrhagic ventricular dilatation. OBJECTIVES: To compare cognitive function, visual and sensorimotor ability, emotional well-being, use of specialist health/rehabilitative and educational services, neuroimaging, and economic costs and benefits at school age. DESIGN: Ten-year follow-up of a randomised controlled trial. SETTING: Neonatal intensive care units (Bristol, Katowice, Glasgow and Bergen). PARTICIPANTS: Fifty-two of the original 77 infants randomised. INTERVENTIONS: DRIFT or standard therapy (cerebrospinal fluid tapping). MAIN OUTCOME MEASURES: Primary - cognitive disability. Secondary - vision; sensorimotor disability; emotional/behavioural function; education; neurosurgical sequelae on magnetic resonance imaging; preference-based measures of health-related quality of life; costs of neonatal treatment and of subsequent health care in childhood; health and social care costs and impact on family at age 10 years; and a decision analysis model to estimate the cost-effectiveness of DRIFT compared with standard treatment up to the age of 18 years. RESULTS: By 10 years of age, 12 children had died and 13 were either lost to follow-up or had declined to participate. A total of 52 children were assessed at 10 years of age (DRIFT, n = 28; standard treatment, n = 24). Imbalances in gender and birthweight favoured the standard treatment group. The unadjusted mean cognitive quotient (CQ) score was 69.3 points [standard deviation (SD) 30.1 points] in the DRIFT group compared with 53.7 points (SD 35.7 points) in the standard treatment group, a difference of 15.7 points, 95% confidence interval (CI) -2.9 to 34.2 points; p = 0.096. After adjusting for the prespecified covariates (gender, birthweight and grade of IVH), this evidence strengthened: children who received DRIFT had a CQ advantage of 23.5 points (p = 0.009). The binary outcome, alive without severe cognitive disability, gave strong evidence that DRIFT improved cognition [unadjusted odds ratio (OR) 3.6 (95% CI 1.2 to 11.0; p = 0.026) and adjusted OR 10.0 (95% CI 2.1 to 46.7; p = 0.004)]; the number needed to treat was three. No significant differences were found in any secondary outcomes. There was weak evidence that DRIFT reduced special school attendance (adjusted OR 0.27, 95% CI 0.07 to 1.05; p = 0.059). The neonatal stay (unadjusted mean difference £6556, 95% CI -£11,161 to £24,273) and subsequent hospital care (£3413, 95% CI -£12,408 to £19,234) costs were higher in the DRIFT arm, but the wide CIs included zero. The decision analysis model indicated that DRIFT has the potential to be cost-effective at 18 years of age. The incremental cost-effectiveness ratio (£15,621 per quality-adjusted life-year) was below the National Institute for Health and Care Excellence threshold. The cost-effectiveness results were sensitive to adjustment for birthweight and gender. LIMITATIONS: The main limitations are the sample size of the trial and that important characteristics were unbalanced at baseline and at the 10-year follow-up. Although the analyses conducted here were prespecified in the analysis plan, they had not been prespecified in the original trial registration. CONCLUSIONS: DRIFT improves cognitive function when taking into account birthweight, grade of IVH and gender. DRIFT is probably effective and, given the reduction in the need for special education, has the potential to be cost-effective as well. A future UK multicentre trial is required to assess efficacy and safety of DRIFT when delivered across multiple sites. TRIAL REGISTRATION: Current Controlled Trials ISRCTN80286058. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 4. See the NIHR Journals Library website for further project information. The DRIFT trial and 2-year follow-up was funded by Cerebra and the James and Grace Anderson Trust.

International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study.

BACKGROUND: Preliminary studies have indicated that music therapy may benefit children with autism spectrum disorders (ASD). OBJECTIVES: To examine the effects of improvisational music therapy (IMT) on social affect and responsiveness of children with ASD. DESIGN: International, multicentre, three-arm, single-masked randomised controlled trial, including a National Institute for Health Research (NIHR)-funded centre that recruited in London and the east of England. Randomisation was via a remote service using permuted blocks, stratified by study site. SETTING: Schools and private, voluntary and state-funded health-care services. PARTICIPANTS: Children aged between 4 and 7 years with a confirmed diagnosis of ASD and a parent or guardian who provided written informed consent. We excluded children with serious sensory disorder and those who had received music therapy within the past 12 months. INTERVENTIONS: All parents and children received enhanced standard care (ESC), which involved three 60-minute sessions of advice and support in addition to treatment as usual. In addition, they were randomised to either one (low-frequency) or three (high-frequency) sessions of IMT per week, or to ESC alone, over 5 months in a ratio of 1 : 1 : 2. MAIN OUTCOME MEASURES: The primary outcome was measured using the social affect score derived from the Autism Diagnostic Observation Schedule (ADOS) at 5 months: higher scores indicated greater impairment. Secondary outcomes included social affect at 12 months and parent-rated social responsiveness at 5 and 12 months (higher scores indicated greater impairment). RESULTS: A total of 364 participants were randomised between 2011 and 2015. A total of 182 children were allocated to IMT (90 to high-frequency sessions and 92 to low-frequency sessions), and 182 were allocated to ESC alone. A total of 314 (86.3%) of the total sample were followed up at 5 months [165 (90.7%) in the intervention group and 149 (81.9%) in the control group]. Among those randomised to IMT, 171 (94.0%) received it. From baseline to 5 months, mean scores of ADOS social affect decreased from 14.1 to 13.3 in music therapy and from 13.5 to 12.4 in standard care [mean difference: music therapy vs. standard care = 0.06, 95% confidence interval (CI) -0.70 to 0.81], with no significant difference in improvement. There were also no differences in the parent-rated social responsiveness score, which decreased from 96.0 to 89.2 in the music therapy group and from 96.1 to 93.3 in the standard care group over this period (mean difference: music therapy vs. standard care = -3.32, 95% CI -7.56 to 0.91). There were seven admissions to hospital that were unrelated to the study interventions in the two IMT arms compared with 10 unrelated admissions in the ESC group. CONCLUSIONS: Adding IMT to the treatment received by children with ASD did not improve social affect or parent-assessed social responsiveness. FUTURE WORK: Other methods for delivering music-focused interventions for children with ASD should be explored. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78923965. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 59. See the NIHR Journals Library website for further project information.

How a concerned family member, friend or member of the public can help someone with gambling problems: a Delphi consensus study.

BACKGROUND: Gambling is an enjoyable recreational pursuit for many people. However, for some it can lead to significant harms. The Delphi expert consensus method was used to develop guidelines for how a concerned family member, friend or member of the public can recognise the signs of gambling problems and support a person to change their gambling. METHODS: A systematic review of websites, books and journal articles was conducted to develop a questionnaire containing items about the knowledge, skills and actions needed for supporting a person with gambling problems. These items were rated over three rounds by two international expert panels comprising people with a lived experience of gambling problems and professionals who treat people with gambling problems or research gambling problems. RESULTS: A total of 66 experts (34 with lived experience and 32 professionals) rated 412 helping statements according to whether they thought the statements should be included in these guidelines. There were 234 helping statements that were endorsed by at least 80 % of members of both of the expert panels. These endorsed statements were used to develop the guidelines. CONCLUSION: Two groups of experts were able to reach substantial consensus on how someone can recognise the signs of gambling problems and support a person to change.

How the causes, consequences and solutions for problem gambling are reported in Australian newspapers: a qualitative content analysis.

OBJECTIVE: To inform public health approaches to problem gambling by examining how the news media covers problem gambling, with a particular focus on the causes, consequences and solutions to problem gambling, and the 'actors' and sources who influence media coverage. METHODS: A qualitative content analysis guided by framing theory analysed coverage of problem gambling in Australian newspapers in the period 1 July 2011 to 30 June 2012. RESULTS: Solutions to problem gambling were more frequently discussed than causes and consequences. A focus on the responsibility of individuals was preferred to reporting that focused on broader social, ecological, and industry determinants of problem gambling. Reporting was highly politicised, with politicians frequently quoted and political issues frequently discussed. In contrast, the community sector, health professionals and problem gamblers were rarely quoted. CONCLUSIONS AND IMPLICATIONS: This analysis has revealed the need for a more proactive, coordinated approach to the media by both public health researchers and health groups. The establishment of a gambling-specific coalition to push for evidence-based reform is recommended.

Coronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery: a randomised controlled trial (the CRISP trial).

BACKGROUND: Coronary artery bypass grafting (CABG) is the treatment of choice for patients with multivessel coronary artery disease (CAD). Evidence from randomised controlled trials (RCTs) in low-risk populations shows that 'off-pump' CABG is at least as safe as 'on-pump' CABG, but high-quality trial data in high-risk populations are lacking. OBJECTIVES: To test the hypothesis that, in high-risk patients, off-pump coronary artery bypass grafting (OPCABG) reduces mortality and morbidity without causing a higher risk of reintervention compared with on-pump coronary artery bypass grafting (ONCABG). DESIGN: Open parallel-group RCT with a 1 : 1 allocation ratio and expertise-based randomisation. SETTING: Eight specialist cardiac surgery centres in the UK and one specialist centre in Kolkata, India. PARTICIPANTS: Patients with an additive European system for cardiac operative risk evaluation score (EuroSCORE) of ≥ 5, undergoing non-emergency isolated CABG via a median sternotomy. INTERVENTIONS: CABG without cardiopulmonary bypass (CPB), i.e. OPCABG on the beating heart, or CABG with CPB, i.e. ONCABG on a chemically arrested heart. MAIN OUTCOME MEASURES: Primary outcome - a composite of death or serious morbidity [all-cause mortality, myocardial infarction (MI), stroke, prolonged initial ventilation, sternal wound dehiscence] within 30 days of surgery. Secondary outcomes - quality of life (QoL) [Rose Angina Questionnaire, Canadian Cardiovascular Society (CCS) angina class, European QoL-5 Dimensions (EQ-5D), Coronary Revascularisation Outcome Questionnaire (CROQ)] and resource utilisation. RESULTS: The organisation of a tertiary cardiac surgery service in the UK presented several barriers to recruitment. Referral information was often inadequate to confirm eligibility. Limited surgeon participation at a centre, the need to meet referral-to-treatment performance targets and complex referral pathways did not support an expertise-based allocation. Urgent patients waiting for surgery in local 'feeder' hospitals were often not transferred until late the night before surgery, which limited the time available to take consent and organise the surgery on an expertise basis. Several elective patients declined to take part because they wanted the surgeon they had met when the surgery was first discussed in clinic to operate. Several initiatives were explored to boost recruitment. After 10 months of recruitment, the trial design was modified to permit both within-surgeon and expertise-based randomisation within a centre. However, this did not have sufficient impact and the trial was stopped on the grounds of futility after 106 patients (< 2% of the target sample size) had been recruited in 18 months. Ninety-eight patients were included in the trial analyses, six patients were withdrawn and two died before surgery. In both groups, 6% of patients experienced the primary outcome [adjusted odds ratio (OR) (OPCABG to ONCABG) 1.07; 95% confidence interval (CI) 0.27 to 4.14]. QoL scores at 4-8 weeks post surgery were similar in the two groups. Patients randomised to OPCABG had a shorter stay in the intensive care unit and in hospital after surgery (median 26.0 vs. 27.7 hours in intensive care and 7 vs. 8 days in hospital). CONCLUSIONS: The Coronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery (CRISP) trial was not successful for a range of logistical reasons. However, the experience gained is of value for the design and conduct of future trials. The surgical community have polarised views. A qualitative evaluation of the reasons behind the views held by the advocates of the two techniques is an area for future research. TRIAL REGISTRATION: Current Controlled Trials ISRCTN29161170. FUNDING: This project was funded by the Medical Research Council/National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation programme and will be published in full in Health Technology Assessment; Vol. 18, No. 44. See the NIHR Journals Library website for further project information.

Assessment of the status of a National Action Plan for Cancer Survivorship in the USA.

PURPOSE: There are currently more than 12 million cancer survivors in the USA. Survivors face many issues related to cancer and treatment that are outside the purview of the clinical care system. Therefore, understanding and providing for the evolving needs of cancer survivors offers challenges and opportunities for the public health system. In 2004, the Centers for Disease Control and Prevention and the Lance Armstrong Foundation, now the Livestrong Foundation, partnered with national cancer survivorship organizations to develop the National Action Plan for Cancer Survivorship (NAPCS). This plan outlines public health strategies to address the needs of cancer survivors. To date, no assessment of NAPCS strategies and their alignment with domestic cancer survivorship activities has been conducted. METHODS: The activities of five national organizations with organized public health agendas about cancer survivorship were assessed qualitatively during 2003-2007. Using the NAPCS as an organizing framework, interviews were conducted with key informants from all participating organizations. Interview responses were supplemented with relevant materials from informants and reviews of the organizations' websites. RESULTS: Strategies associated with surveillance and applied research; communication, education, and training; and programs, policy, and infrastructure represent a large amount of the organizational efforts. However, there are gaps in research on preventive interventions, evaluation of implemented activities, and translation. CONCLUSIONS: Numerous NAPCS strategies have been implemented. Future efforts of national cancer survivorship organizations should include rigorous evaluation of implemented activities, increased translation of research to practice, and assessment of dissemination efforts. IMPLICATIONS FOR CANCER SURVIVORS: The results of this descriptive assessment provide cancer survivors, cancer survivorship organizations, researchers, providers, and policy makers with initial information about cancer survivorship public health efforts in the USA. Additionally, results suggest areas in need of further attention and next steps in advancing the national cancer survivorship public health agenda.

Development of a tool to support holistic generic assessment of clinical procedure skills.

CONTEXT: The challenges of maintaining comprehensive banks of valid checklists make context-specific checklists for assessment of clinical procedural skills problematic. OBJECTIVES: This paper reports the development of a tool which supports generic holistic assessment of clinical procedural skills. METHODS: We carried out a literature review, focus groups and non-participant observation of assessments with interview of participants, participant evaluation of a pilot objective structured clinical examination (OSCE), a national modified Delphi study with prior definitions of consensus and an OSCE. Participants were volunteers from a large acute teaching trust, a teaching primary care trust and a national sample of National Health Service staff. Results In total, 86 students, trainees and staff took part in the focus groups, observation of assessments and pilot OSCE, 252 in the Delphi study and 46 candidates and 50 assessors in the final OSCE. We developed a prototype tool with 5 broad categories amongst which were distributed 38 component competencies. There was > 70% agreement (our prior definition of consensus) at the first round of the Delphi study for inclusion of all categories and themes and no consensus for inclusion of additional categories or themes. Generalisability was 0.76. An OSCE based on the instrument has a predicted reliability of 0.79 with 12 stations and 1 assessor per station or 10 stations and 2 assessors per station. CONCLUSIONS: This clinical procedural skills assessment tool enables reliable assessment and has content and face validity for the assessment of clinical procedural skills. We have designated it the Leicester Clinical Procedure Assessment Tool (LCAT).

Checklists for assessment and certification of clinical procedural skills omit essential competencies: a systematic review.

OBJECTIVE: To develop generic criteria for the global assessment of clinical procedural competence and to quantify the extent to which existing checklists allow for holistic assessment of procedural competencies. METHODS: We carried out a systematic review and qualitative analysis of published clinical procedural skills assessment checklists and enumerated the contents of each. Source materials included all English-language papers published from 1990 to June 2005, identified from 18 databases, which described or referred to an assessment document for any clinical procedural skill. A pair of reviewers identified key generic themes and sub-themes through in-depth analysis of a subset of 20 checklists with iterative agreement and independent retesting of a coding framework. The resulting framework was independently applied to all checklists by pairs of reviewers checking for the emergence of new themes and sub-themes. Main outcome measures were identification of generic clinical procedural skills and the frequency of occurrence of each in the identified checklists. RESULTS: We identified 7 themes ('Procedural competence', represented in 85 [97%] checklists; 'Preparation', 65 [74%]; 'Safety', 45 [51%]; 'Communication and working with the patient', 32 [36%]; 'Infection control', 28 [32%]; 'Post-procedural care', 24 [27%]; 'Team working', 13 [15%]) and 37 sub-themes, which encapsulated all identified checklists. Of the sub-themes, 2 were identified after the initial coding framework had been finalised. CONCLUSIONS: It is possible to develop generic criteria for the global assessment of clinical procedural skills. A third and a half of checklists, respectively, do not enable explicit assessment of the key competencies 'Infection control' and 'Safety'. Their assessment may be inconsistent in assessments which use such checklists.

Medical treatment at Louis Armstrong New Orleans International Airport after hurricane Katrina: the experience of disaster medical assistance teams WA-1 and OR-2.

In the week following Hurricane Katrina, over 3000 patients were evacuated by air from a triage and medical treatment station at the Louis Armstrong New Orleans International Airport. This represents the largest air evacuation in history. Over 24,000 additional evacuees were transported from the airport to shelters. Disaster Medical Assistance Teams (DMATs) from several US states were deployed to the Louis Armstrong New Orleans International Airport to provide medical care to those evacuated from New Orleans. Despite warning from the US National Weather Service of catastrophic damage to New Orleans, adequate medical staffing was not attained at the airport triage station until 6 days after the hurricane struck. Organizational lapses, including inadequate medical and operational planning, understaffing of medical personnel, and failure to utilize Incident Command System, diminished the effectiveness of the Hurricane Katrina New Orleans Medical Operation.