Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED): a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes

Background Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team. Methods/design Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period. Discussion The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context. Trial registration Current Controlled Trials ISRCTN61568050

Technical factors related to the incidence of adjacent superior segment facet joint violation after transpedicular instrumentation in the lumbar spine

Segmental pedicle screw fixation is rapidly becoming a popular method of spinal instrumentation. Few studies have investigated the rates of adjacent superior segment facet joint violation. The purpose of our study were to investigate the incidence of superior segment facet joint violation after pedicle screw instrumentation in the lumbar spine and to evaluate technical factors related to the incidence. A prospective study including 96 patients who underwent lumbar and lumbosacral fusion was conducted between March 2006 and December 2007. All patients had bilateral or unilateral posterior pedicle screw-rod instrumentation with either CD-Horizon (top-loading screw) or TSRH (side-connecting screw) implants. Pedicle screws were instrumented according to the methods advocated by Roy-Camille (Group 1, 20 cases) or Weinstein (Group 2, 76 cases). All patients had computed tomography scan at 1 week post operation. CT scans were reviewed blind by an experienced spine research fellow and a consultant radiologist to determine violation of the adjacent superior segment facet joint. Superior segment facet joint violation occurred in all of the 20 patients (100%) and all of the top-level screws (100%) in Group 1. The spinal research fellow noted the incidence of facet joint violation to be present in 23.8% of the screws and 32.9% of the patients in Group 2, whereas the consultant radiologist noted this to be the case in 25.2 and 35.5%, respectively. The incidence of facet joint violation in patients with CD-Horizon screws was far lower than patients with TSRH screws (P < 0.001). In conclusion, it seems that meticulous surgical dissection without injuring the top-level facet joints, proper instrumentation of pedicle screws with the appropriate entry site (Weinstein’s method), trajectory, and use of top-loading screw heads are some ways that surgeons could minimize the risk of top-level facet joint violation