Learning from the QUEST multicentre feasibility randomization trials in breast reconstruction after mastectomy

BACKGROUND: Breast reconstruction aims to improve health-related quality of life after mastectomy. However, evidence guiding patients and surgeons in shared decision-making concerning the optimal type or timing of surgery is lacking.

METHODS: QUEST comprised two parallel feasibility phase III randomized multicentre trials to assess the impact of the type and timing of latissimus dorsi breast reconstruction on health-related quality of life when postmastectomy radiotherapy is unlikely (QUEST A) or highly probable (QUEST B). The primary endpoint for the feasibility phase was the proportion of women who accepted randomization, and it would be considered feasible if patient acceptability rates exceeded 25 per cent of women approached. A companion QUEST Perspectives Study (QPS) of patients (both accepting and declining trial participation) and healthcare professionals assessed trial acceptability.

RESULTS: The QUEST trials opened in 15 UK centres. After 18 months of recruitment, 17 patients were randomized to QUEST A and eight to QUEST B, with overall acceptance rates of 19 per cent (17 of 88) and 22 per cent (8 of 36) respectively. The QPS recruited 56 patients and 51 healthcare professionals. Patient preference was the predominant reason for declining trial entry, given by 47 (53 per cent) of the 88 patients approached for QUEST A and 22 (61 per cent) of the 36 approached for QUEST B. Both trials closed to recruitment in December 2012, acknowledging the challenges of achieving satisfactory patient accrual.

CONCLUSION: Despite extensive efforts to overcome recruitment barriers, it was not feasible to reach timely recruitment targets within a feasibility study. Patient preferences for breast reconstruction types and timings were common, rendering patients unwilling to enter the trial.

Protocol for a feasibility study of a self help cognitive behavioural therapy resource for the reduction of dental anxiety in young people

Background Childhood dental anxiety is very common, with 10–20 % of children and young people reporting high levels of dental anxiety. It is distressing and has a negative impact on the quality of life of young people and their parents as well as being associated with poor oral health. Affected individuals may develop a lifelong reliance on general anaesthetic or sedation for necessary dental treatment thus requiring the support of specialist dental services. Children and young people with dental anxiety therefore require additional clinical time and can be costly to treat in the long term. The reduction of dental anxiety through the use of effective psychological techniques is, therefore, of high importance. However, there is a lack of high-quality research investigating the impact of cognitive behavioural therapy (CBT) approaches when applied to young people’s dental anxiety. Methods/design The first part of the study will develop a profile of dentally anxious young people using a prospective questionnaire sent to a consecutive sample of 100 young people referred to the Paediatric Dentistry Department, Charles Clifford Dental Hospital, in Sheffield. The second part will involve interviewing a purposive sample of 15–20 dental team members on their perceptions of a CBT self-help resource for dental anxiety, their opinions on whether they might use such a resource with patients, and their willingness to recruit participants to a future randomised controlled trial (RCT) to evaluate the resource. The third part of the study will investigate the most appropriate outcome measures to include in a trial, the acceptability of the resource, and retention and completion rates of treatment with a sample of 60 dentally anxious young people using the CBT resource. Discussion This study will provide information on the profile of dentally anxious young people who could potentially be helped by a guided self-help CBT resource. It will gain the perceptions of dental care team members of guided self-help CBT for dental anxiety in young people and their willingness to recruit participants to a trial. Acceptability of the resource to participants and retention and completion rates will also be investigated to inform a future RCT.

Feasibility of trialling cord blood stem cell treatments for cerebral palsy in Australia

Umbilical cord blood may have therapeutic benefit in children with cerebral palsy (CP), but further studies are required. On first appearance it seems that Australia is well placed for such a trial because we have excellence in CP research backed by extensive CP registers, and both public and private cord blood banks. We aimed to examine the possibilities of conducting a trial of autologous umbilical cord blood cells (UCBCs) as a treatment for children with CP in Australia.

Feasibility of changeable message signs and highway advisory radio for freeway maintenance. Final report.

Texas State Department of Highways and Public Transportation, Transportation Planning Division, Austin

A feasibility study of a sealed safety monitor for trucks carrying LNG and other hazardous materials. Final report.

Energy Department, Office of Operational Safety Programs, Washington, D.C.

Studies supporting the evaluation of the Uniform Tire Quality Grading System Program effects on the consumer marketplace. Final technical report.

National Highway Traffic Safety Administration, Washington, D.C.

Feasibility study for an improved acoustic probe for road roughness profiling.

Federal Highway Administration, Washington, D.C.

Identification and feasibility test of specialized rural pedestrian safety training. Volume 3: PEDSAFE junior/senior high school materials. Final report.

National Highway Traffic Safety Administration, Washington, D.C.

Identification and feasibility test of specialized rural pedestrian safety training. Volume 4: PEDSAFE audiovisual scripts. Final report.

National Highway Traffic Safety Administration, Washington, D.C.

Systems feasibility study: states' assistance in defect recall campaigns. Final report, Volume I.

National Highway Traffic Safety Administration, Washington, D.C.

Systems feasibility study: states' assistance in defect recall campaigns. Final report, Volume II.

National Highway Traffic Safety Administration, Washington, D.C.

Systems feasibility study: states' assistance in defect recall campaigns. Final report, Volume III.

National Highway Traffic Safety Administration, Washington, D.C.

Systems feasibility study: states' assistance in defect recall campaigns. Final report, Volume IV.

National Highway Traffic Safety Administration, Washington, D.C.

Identification and feasibility test of specialized rural pedestrian safety training. Volume 2: PEDSAFE elementary materials. Final report.

National Highway Traffic Safety Administration, Washington, D.C.

Feasibility study of combining HVOSM and BARRIER VII. Final report.

Turner-Fairbank Highway Research Center, McLean, Va.