Search

Objective: To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes., Design: Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation., Setting: 11 diabetes clinics in England and Wales., Participants: Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention., Intervention: We designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment. OUTCOME MEASURES AT 3 AND 6 MONTHS: Primary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use., Results: Of the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=-4.68; SE=1.74; 95%CI from -8.10 to -1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents., Conclusions: Standardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes., Trial Registration Number: ISRCTN17551624., Competing Interests: Competing interests: Professor JWG has received payments from Pfizer, Bayer and Ipsen for lectures, development of educational presentations and travel/accommodation to attend scientific meetings and advisory board meetings. His employer (Cardiff University) has also received funding from Novo Nordisk to support the development of patient-support materials used in the Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED) research study., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Objective: To explore patients' experience of receiving pain relief injection for suspected hip fracture from paramedics at the location of the injury., Design: Qualitative interviews within a feasibility trial about an alternative to routine prehospital pain management for patients with suspected hip fracture., Setting: Patients treated by paramedics in the catchment area of one emergency department in South Wales., Participants: Six patients and one carer of a patient who received fascia iliaca compartment block (FICB)., Intervention: FICB administered to patients with suspected hip fracture by trained paramedics. We randomly allocated eligible patients to FICB-a local anaesthetic injection directly into the hip region-or usual care-most commonly morphine-using audited scratch cards., Outcomes: Acceptability and experience of receiving FICB, assessed through interview data. We audio-recorded, with participants' consent, and conducted thematic analysis of interview transcripts. The analysis team comprised two researchers, one paramedic and one lay member., Results: Patients had little or no memory of being offered, consenting to or receiving FICB. They recalled the reassuring manner and high quality of care received. They accepted FICB without question. Partial or confused memory characterised experience of subsequent hospital care until surgery. They said their priorities when calling for emergency help were to receive effective care. After hospital treatment, they wanted to regain their health and mobility and resume the quality of life they experienced before their injury., Conclusions: This study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture. It adds to existing evidence about patient and carer experience of on-scene care for people with suspected hip fracture. Further research is needed to assess safety, effectiveness and cost effectiveness of this health technology in a new setting., Trial Registration Number: ISRCTN60065373., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To estimate the effect of deprivation on the demand for calls to National Health Service Direct Wales (NHSDW) controlling for confounding factors., Design: Study of routine data on over 400 000 calls to NHSDW using multiple regression to analyse the logarithms of ward-specific call rates across Wales by characteristics of call, patient and ward, notably the Welsh Index of Multiple Deprivation., Setting: 810 electoral wards with average population of 3300, defined by 1998 administrative boundaries., Population: All calls to NHSDW between January 2002 and June 2004., Main Outcome Measures: We used ward populations as denominators to calculate the rates of three categories of calls: calls seeking advice, calls seeking information and all calls combined., Results: Confounding variables explained 31% of variation in advice call rates, but only 14% of variation in information call rates and in all call rates (all significant at 0.1% level). However, deprivation was only a statistically significant predictor of information call rates. The proportion of the ward population categorised as 'white' was a highly significant predictor of all three call rates. For advice calls and combined calls, rates decreased highly significantly with the proportion of those who called the service for themselves. Information call rates were higher on weekdays and highest on Mondays, while advice call rates were highest on Sundays., Conclusions: Deprivation had no consistent effect on demand for the service and the relationship needs further exploration. While our data may have underestimated the 'need' of deprived patients, they yield no evidence that policy-makers should seek to improve demand from those patients. However, we found differences in the way callers use advice and information calls. Previously unexplored variables that help to predict ward-specific call rates include: ethnicity, day of the week and whether patients made the calls themselves., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To explore paramedics' experience of delivering fascia iliaca compartment block ( FICB) to patients with suspected hip fracture at the scene of injury., Design: Focus groups within a randomised controlled trial., Setting: Paramedics based at ambulance stations in the catchment area of one Emergency Department in South Wales, recruited and trained in a feasibility study about an alternative to routine prehospital pain management for patients with suspected hip fracture., Participants: 11 paramedics., Intervention: Paramedic-administered FICB to patients with suspected hip fracture. We randomly allocated eligible patients to FICB, a local anaesthetic injection directly into the hip region-or usual care, most commonly morphine - using audited scratch cards., Outcomes: Paramedics' experiences of administering FICB gathered through thematic analysis of interview transcripts by two researchers, one paramedic and one lay member., Results: Respondents believed that FICB was a suitable intervention for paramedics to deliver. It aligned with routine practice and was within people's capabilities. They said it took up to 10 minutes longer than usual care to prepare and deliver, in part due to nervousness and unfamiliarity with a new procedure. They praised the training provided but said they were anxious about causing harm by injecting into the wrong location. Confidence increased after one paramedic team successfully treated a patient for local anaesthetic toxicity. Reported challenges related to the emergency context: patients often waited many hours for ambulance arrival; moving patients exacerbated their pain; family and neighbours were present as paramedics administered treatment., Conclusions: Paramedics are willing and able to administer FICB to patients with suspected hip fracture before ambulance transport to hospital. Feasibility study findings will inform further research., Trial Registration Number: ISRCTN60065373; Pre results., Competing Interests: Competing interests: IP is Director of Trauma Simulation, which produced the bespoke mannequin used in training. The other authors declare that they have no competing interests., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Incisional hernias are common complications of midline abdominal closure. The 'Hughes Repair' combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. There is evidence to suggest this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared Hughes repair with standard mass closure for the prevention of incisional hernia formation. This paper aims to test the feasibility of running a randomised controlled trial of a comparison of abdominal wall closure methods following midline incisional surgery for colorectal cancer, in preparation to a definitive randomised controlled trial., Design and Setting: A feasibility trial (with 1:1 randomisation) conducted perioperatively during colorectal cancer surgery., Participants: Patients undergoing midline incisional surgery for resection of colorectal cancer., Interventions: Comparison of two suture techniques (Hughes repair or standard mass closure) for the closure of the midline abdominal wound following surgery for colorectal cancer., Primary and Secondary Outcomes: A 30-patient feasibility trial assessed recruitment, randomisation, deliverability and early safety of the surgical techniques used., Results: A total of 30 patients were randomised from 43 patients recruited and consented, over a 5-month period. 14 and 16 patients were randomised to arms A and B, respectively. There was one superficial surgical site infection (SSI) and two organ space SSIs reported in arm A, and two superficial SSIs and one complete wound dehiscence in arm B. There were no suspected unexpected serious adverse reactions reported in either arm. Independent data monitoring committee found no early safety concerns., Conclusions: The feasibility trial found no early safety concerns and demonstrated that the trial was acceptable to patients. Progression to the pilot and main phases of the trial has now commenced following approval by the independent data monitoring committee., Trial Registration Number: ISRCTN 25616490., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Only 30-40% of depressed patients treated with medication achieve full remission. Studies that change medication or augment it by psychotherapy achieve only limited benefits, in part because current treatments are not designed for chronic and complex patients. Previous trials have excluded high-risk patients and those with comorbid personality disorder. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a novel, transdiagnostic treatment for disorders of emotional over-control. The REFRAMED trial aims to evaluate the effectiveness and cost-effectiveness of RO-DBT for patients with treatment-resistant depression., Methods and Analysis: REFRAMED is a multicentre randomised controlled trial, comparing 7 months of individual and group RO-DBT treatment with treatment as usual (TAU). Our primary outcome measure is depressive symptoms 12 months after randomisation. We shall estimate the cost-effectiveness of RO-DBT by cost per quality-adjusted life year. Causal analyses will explore the mechanisms by which RO-DBT is effective., Ethics and Dissemination: The National Research Ethics Service (NRES) Committee South Central - Southampton A first granted ethical approval on 20 June 2011, reference number 11/SC/0146., Trial Registration Number: ISRCTN85784627., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objective: Explore professional views of changes to gastroenterology service organisation and delivery and barriers and facilitators impacting on change. The work was undertaken as part of an evaluation in endoscopy service provision catalysed by the Modernising Endoscopy Services Programme of the Modernisation Agency., Design: Focus groups followed by analysis and group-working activities identifying key themes., Setting: English and Welsh secondary care gastroenterology units., Participants: 20 professionals working in gastroenterology in England and Wales. Medical, surgical and nursing specialists including endoscopy nurses. Opportunistic sampling to include senior people in leadership and management roles who were directly involved in service modernisation, excluding those involved in the Modernisation Endoscopy Services Programme., Results: Four 1.5 h focus groups took place in 2007. Summative and thematic analyses captured essential aspects of text and achieved consensus on key themes. 4 themes were revealed: 'loss of personal autonomy and erosion of professionalism', 'lack of senior management understanding', 'barriers and facilitators to change' and 'differences between English and Welsh units'. Themes indicated that low staff morale, lack of funding and senior management support were barriers to effective change. Limitations to the study include the disproportionately low number of focus group attendees from English units and the time delay in reporting these findings., Conclusions: Despite ambitions to implement change, ineffective management support continued to hamper modernisation of service organisation and delivery. While the National Health Service Modernisation Agency Modernising Endoscopy Services Programme acted as a catalyst for change, affecting the way staff work, communicate and think, it was not effective in heralding change itself. However, gastroenterologists were keen to consider the potential for change and future service modernisation. The methodological framework of innovative qualitative enquiry offers comprehensive and rigorous enhancement of quantitative studies, including randomised trials, when a mixed methods approach is needed.