A qualitative account of young people's experiences of alcohol screening and brief interventions in schools: SIPS Jr-HIGH trial findings.

BACKGROUND: The United Kingdom (UK) has seen a decrease in the number of young people drinking alcohol. However, the UK prevalence of underage drinking still ranks amongst the highest in Western Europe. Whilst there is a wealth of evidence reporting on the effectiveness of both primary, and secondary interventions, there are few reports of the experiences of young people who receive them. METHODS: The present study reports findings from interviews with 33 young people who were involved in an alcohol screening and brief intervention randomized controlled trial in schools in England. All interviews were analysed using inductive applied thematic analysis. RESULTS: Three major themes were identified following the analysis process: 1) drinking identities and awareness of risk; 2) access to support and advice in relation to alcohol use; and 3) appraisal of the intervention and potential impact on alcohol use. CONCLUSIONS: There appeared to be a reluctance from participants to describe themselves as someone who drinks alcohol. Furthermore, those who did drink alcohol often did so with parental permission. There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff. Overall participants felt the intervention was useful, but would be better suited to 'heavier' drinkers.

Feasibility and acceptability of combining cognitive behavioural therapy techniques with swallowing therapy in head and neck cancer dysphagia.

BACKGROUND: Head and neck cancer squamous cell carcinoma (HNSSC) patients report substantial rates of clinically significant depression and/or anxiety, with dysphagia being a predictor of distress and poorer quality of life. Evidence-based dysphagia interventions largely focus on the remediation of physical impairment. This feasibility study evaluates an intervention which simultaneously uses a psychological therapy approach combined with swallowing impairment rehabilitation. METHODS: This prospective single cohort mixed-methods study, recruited HNSCC patients with dysphagia, from two institutions. The intervention combined Cognitive Behavioural Therapy with swallowing therapy (CB-EST), was individually tailored, for up to 10 sessions and delivered by a speech and language therapist. Primary acceptability and feasibility measures included recruitment and retention rates, data completion, intervention fidelity and the responsiveness of candidate outcome measures. Measures included a swallowing questionnaire (MDADI), EORTC-QLQH&N35, dietary restrictions scale, fatigue and function scales and the Hospital Anxiety and Depression Scale (HADS), administered pre-, post-CB-EST with three month follow-up and analysed using repeated measures ANOVA. Qualitative interviews were conducted to evaluate intervention processes. RESULTS: A total of 30/43 (70%) eligible patients agreed to participate and 25 completed the intervention. 84% were male, mean age 59 yrs. Patients were between 1 and 60 months (median 4) post-cancer treatment. All patients had advanced stage disease, treated with surgery and radiotherapy (38%) or primary chemoradiotherapy (62%). Pre to post CB-EST data showed improvements in MDADI scores (p = 0.002), EORTC-QLQH&N35 (p = 0.006), dietary scale (p < 0.0001), fatigue (p = 0.002) but no change in function scales or HADS. Barriers to recruitment were the ability to attend regular appointments and patient suitability or openness to a psychological-based intervention. CONCLUSIONS: CB-EST is a complex and novel intervention, addressing the emotional, behavioural and cognitive components of dysphagia alongside physical impairment. Preliminary results are promising. Further research is required to evaluate efficacy and effectiveness.

Understanding frames: A qualitative study of young people's experiences of using standing frames as part of postural management for cerebral palsy.

BACKGROUND: Consensus opinion supports standing frame use as part of postural management for nonambulant young people with cerebral palsy. Although the rationale for standing frame use and the associated challenges have been described, little attention has been given to the users' experiences. The aim of the current study was to explore young people's positive and negative experiences, and attitudes regarding standing frame use. METHODS: Framework analysis informed an open exploration of young people's opinions of standing frames. Using semistructured interviews, 12 young people with cerebral palsy (6 female) were interviewed, providing the data set for transcription and thematic analysis. FINDINGS: The first theme "attitudes to standing frames" describes the young people's understanding of why they use standing frames. Although standing frames can be painful, some young people believe they should be endured to improve their body structure and function. There were mixed views about the impact standing frames have socially, with some young people feeling excluded from their peers, and others feeling as though standing frames helped them "fit in." Some young people are not offered a choice about how and when they use their standing frame. The second theme "challenges of standing frame use" highlights the issues with standing frame use such as manual handling, interference from siblings, and the lack of aesthetically pleasing standing frame designs. CONCLUSIONS: Young people report benefits related to choice, pain relief, and participation but can also cause pain, discomfort, and reduced independence and participation. Healthcare professionals should have open, informative conversations about potential benefits and challenges of standing frames on all aspects of the young people's lives, including participation and activity.

Understanding frames: A UK survey of parents and professionals regarding the use of standing frames for children with cerebral palsy.

BACKGROUND: Standing frames are used for children with cerebral palsy (CP). They may improve body structure and function (e.g., reducing risk of hip subluxation, and improving bladder and bowel function), improving activity (e.g., motor abilities) and participation (e.g., interaction with peers), but there is little evidence that they do. We aimed to identify current UK standing frame practice for children with CP and to understand stakeholder views regarding their clinical benefits and challenges to use. METHOD: Three populations were sampled: clinicians prescribing standing frames for children with CP (n = 305), professionals (health and education) working with children with CP who use standing frames (n = 155), and parents of children with CP who have used standing frames (n = 91). Questionnaires were developed by the co-applicant group and piloted with other professionals and parents of children with CP. They were distributed online via clinical and parent networks across the UK. RESULTS: Prescribing practice was consistent, but achieving the prescribed use was not always possible. Respondents in all groups reported the perceived benefits of frames, which include many domains of the International Classification of Functioning Disability and Health for Children and Youth. Challenges of use are related to physical space and child-reported pain. CONCLUSIONS: These survey findings provide information from key stakeholders regarding current UK standing frame practice.

Impact of early clinical exposure on the learning experience of undergraduate dental students.

AIMS: The aim of this research was to evaluate the impact of early clinical exposure on the learning experiences of undergraduate dental students. METHODS: This study was based on mixed methods. The first phase involved administering a purposely designed questionnaire consisting of 16 items, grouped into three subscales. The second phase of the research was conducted using qualitative semi-structured interviews to explore the perceptions and experiences of stakeholders regarding early clinical exposure. RESULTS: In total, 134 undergraduate dental students and eight clinical supervisors responded to the questionnaire and reported positive perceptions regarding the learning experiences, professional relationship and learning environment. Qualitative interviews were conducted with 12 participants, and early clinical exposure was perceived to be useful in providing a context to theoretical learning and development of interpersonal skills. Curriculum overload and further need for consolidation were highlighted as the main challenges. CONCLUSIONS: This study provided insights into the clinical training model in an undergraduate dental programme and highlights the benefits and challenges of early clinical exposure in the study population. The study served as a vehicle for engagement with a range of stakeholders using a mixed methods approach to inform further development of the training model.

Autologous tolerogenic dendritic cells for rheumatoid and inflammatory arthritis.

OBJECTIVES: To assess the safety of intra-articular (IA) autologous tolerogenic dendritic cells (tolDC) in patients with inflammatory arthritis and an inflamed knee; to assess the feasibility and acceptability of the approach and to assess potential effects on local and systemic disease activities. METHODS: An unblinded, randomised, controlled, dose escalation Phase I trial. TolDC were differentiated from CD14+ monocytes and loaded with autologous synovial fluid as a source of autoantigens. Cohorts of three participants received 1×106, 3×106 or 10×106 tolDC arthroscopically following saline irrigation of an inflamed (target) knee. Control participants received saline irrigation only. Primary outcome was flare of disease in the target knee within 5 days of treatment. Feasibility was assessed by successful tolDC manufacture and acceptability via patient questionnaire. Potential effects on disease activity were assessed by arthroscopic synovitis score, disease activity score (DAS)28 and Health Assessment Questionnaire (HAQ). Immunomodulatory effects were sought in peripheral blood. RESULTS: There were no target knee flares within 5 days of treatment. At day 14, arthroscopic synovitis was present in all participants except for one who received 10×106 tolDC; a further participant in this cohort declined day 14 arthroscopy because symptoms had remitted; both remained stable throughout 91 days of observation. There were no trends in DAS28 or HAQ score or consistent immunomodulatory effects in peripheral blood. 9 of 10 manufactured products met quality control release criteria; acceptability of the protocol by participants was high. CONCLUSION: IA tolDC therapy appears safe, feasible and acceptable. Knee symptoms stabilised in two patients who received 10×106 tolDC but no systemic clinical or immunomodulatory effects were detectable. TRIAL REGISTRATION NUMBER: NCT01352858.

Keeping children safe at home: protocol for a case-control study of modifiable risk factors for scalds.

BACKGROUND: Scalds are one of the most common forms of thermal injury in young children worldwide. Childhood scald injuries, which mostly occur in the home, result in substantial health service use and considerable morbidity and mortality. There is little research on effective interventions to prevent scald injuries in young children. OBJECTIVES: To determine the relationship between a range of modifiable risk factors for medically attended scalds in children under the age of 5 years. DESIGN: A multicentre case-control study in UK hospitals and minor injury units with parallel home observation to validate parental reported exposures. Cases will be 0-4 years old with a medically attended scald injury which occurred in their home or garden, matched on gender and age with community controls. An additional control group will comprise unmatched hospital controls drawn from children aged 0-4 years attending the same hospitals and minor injury units for other types of injury. Conditional logistic regression will be used for the analysis of cases and matched controls, and unconditional logistic regression for the analysis of cases and unmatched controls to estimate ORs and 95% CI, adjusted and unadjusted for confounding variables. MAIN EXPOSURE MEASURES: Use of safety equipment and safety practices for scald prevention and scald hazards. DISCUSSION: This large case-control study will investigate modifiable risk factors for scalds injuries, adjust for potential confounders and validate measures of exposure. Its findings will enhance the evidence base for prevention of scalds injuries in young children.

Head and neck cancer and dysphagia; caring for carers.

OBJECTIVES: A diagnosis of head and neck cancer (HNC) is a profound event for patients and family members who play a crucial role in their care. Eating and drinking difficulties affect patients' quality of life (QOL), but the impact on the carers' QOL has not been explored. This preliminary mixed method study reports on carer QOL over time and investigates the relationship with dysphagia. METHODS: Two hundred and eight HNC patients referred for (chemo)radiotherapy were asked to identify a carer and complete a health-related QOL and a swallowing QOL questionnaire at pre-treatment, 3 and 12 months post-treatment. Carers were given the Caregiver QOL-Cancer (CQOL-C) questionnaire at the same time points. A purposive sample of patient and carer dyads was observed over mealtimes and interviewed. RESULTS: Seventy per cent of carers returned a questionnaire at least once. There was no change in CQOL-C scores between pre-treatment and 3 months, but a significant improvement was found between 3 and 12 months post-treatment (p = 0.012). Patient-reported outcomes accounted for 52% of variance in carer QOL measurements (R(2) = 0.52, p < 0.001). Four themes emerged from the qualitative data food provision, monitoring, motivation and changes to lifestyle. CONCLUSIONS: Findings suggest a relationship between carer and patient QOL. Elsewhere, these two characteristics have been associated such that the greater the patients' physical care needs, the poorer the carers' and patients' QOL. Living with someone with dysphagia not only involves managing the physical swallowing difficulties but is also likely to impact on social activities such as participation in shared meals, leading to permanent lifestyle changes.

Measuring disease activity and damage in discoid lupus erythematosus.

BACKGROUND: Discoid lupus erythematosus (DLE) is a disfiguring inflammatory skin disease. There is no specific tool for measuring disease severity. OBJECTIVES: To determine the features needed in a score measuring activity and damage in DLE and to investigate the score's reliability and its correlation with the physician's global assessment of disease severity and the patient-reported Dermatology Quality of Life Index (DLQI). METHODS: The content of the score was determined following a peer review, pilot work in patients and a preliminary inter-rater reliability study. The Score of Activity and Damage in DLE (SADDLE) measures severity of activity (erythema, scale, induration) and damage (scarring/atrophy and dyspigmentation) attributable to DLE. Summed scores range between 0 and 195. Inter- and intrarater reliability of the score was tested using six assessors and nine patients with DLE. Intraclass correlation coefficients (ICCs) > 0.7 were considered evidence of good inter- and intrarater agreement. RESULTS: The mean +/- SD SADDLE score of nine patients in the inter-rater reliability study was 47 +/- 22 (range 14-102). There was good inter-rater agreement for the total score [ICC 0.82; 95% confidence interval (CI) 0.61-0.95] and for the activity and damage scales, the individual physical signs and the total scores at individual body sites. The total score demonstrated excellent intrarater reliability (ICC 0.98; 95% CI 0.86-1.00). Although there was poor inter-rater agreement for global assessments (ICC 0.28; 95% CI 0.06-0.66), a good correlation was demonstrated between total scores and global assessments (r = 0.7). A weaker positive correlation was observed between disease activity scores and DLQI (r = 0.4). CONCLUSIONS: The SADDLE measures activity and damage in patients with DLE. It demonstrates good inter- and excellent intrarater agreement, over and above that for global assessment. It correlates well with global assessment scores. Further studies are required to investigate SADDLE's responsiveness to change with therapy.

Child Caries Management: A Randomized Controlled Trial in Dental Practice.

This multicenter 3-arm, parallel-group, patient-randomized controlled trial compared clinical effectiveness of 3 treatment strategies over 3 y for managing dental caries in primary teeth in UK primary dental care. Participants aged 3 to 7 y with at least 1 primary molar with dentinal carious lesion were randomized across 3 arms (1:1:1 via centrally administered system with variable-length random permuted blocks): C+P, conventional carious lesion management (complete carious tooth tissue removal and restoration placement) with prevention; B+P, biological management (sealing in carious tooth tissue restoratively) with prevention; and PA, prevention alone (diet, plaque removal, fluorides, and fissure sealants). Parents, children, and dentists were not blind to allocated arm. Co-primary outcomes were 1) the proportion of participants with at least 1 episode of dental pain and/or infection and 2) the number of episodes of dental pain and/or infection during follow-up (minimum, 23 mo). In sum, 1,144 participants were randomized (C+P, n = 386; B+P, n = 381; PA, n = 377) by 72 general dental practitioners, of whom 1,058 (C+P, n = 352; B+P, n = 352; PA, n = 354) attended at least 1 study visit and were included in the primary analysis. The median follow-up was 33.8 mo (interquartile range, 23.8 to 36.7). Proportions of participants with at least 1 episode of dental pain and/or infection were as follows: C+P, 42%; B+P, 40%; PA, 45%. There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P. The mean (SD) number of episodes of dental pain and/or infection were as follows: C+P, 0.62 (0.95); B+P, 0.58 (0.87); and PA, 0.72 (0.98). Superiority could not be concluded for number of episodes between B+P (adjusted incident rate ratio (97.5% CI): 0.95 [0.75 to 1.21]) or PA (1.18 [0.94 to 1.48]) and C+P. In conclusion, there was no evidence of a difference among the 3 treatment approaches for incidence or number of episodes of dental pain and/or infection experienced by these participants with high caries risk and established disease (trial registration: ISRCTN77044005).

Stepped treatment of older adults on laxatives. The STOOL trial.

OBJECTIVES: To investigate the clinical effectiveness and cost-effectiveness of bulk-forming, stimulant and osmotic laxatives, and also of adding a second type of laxative agent in the treatment of patients whose constipation is not resolved by a single agent. Additionally, to define the meaning of constipation in older people from the perspective of GPs and older patients, and to investigate the use of prescribed and non-prescribed treatments for constipation in older people together with their adherence to prescribed treatments. DESIGN: A multicentre pragmatic, factorial randomised controlled trial with economic evaluation and qualitative study using in-depth interviews and focus groups with older people, GPs and community nurses. SETTING: General practices in north-east England. PARTICIPANTS: People aged 55 years or over with chronic constipation living in private households. INTERVENTIONS: Six stepped-treatment strategies using three classes of laxatives: bulk, stimulant and osmotic preparations, singly and in combination. MAIN OUTCOME MEASURES: The primary outcome was the constipation-specific Patient Assessment of Constipation--Symptoms/Patient Assessment of Constipation--Quality of Life. Secondary outcomes included EuroQoL 5 Dimensions, reported number of bowel movements per week, the presence/absence of the other Rome II criteria for constipation, adverse effects of treatment and relapse rates. RESULTS: Recruitment to the trial was difficult and the trial was closed after recruiting 19 participants. GP participants provided patient-centred definitions that focused on the idea of a change from the norm as defined by the individual patient and 'textbook definitions' that focused on reduced frequency of defecation associated with a range of unpleasant sensations and other clinical symptoms. Nurses' definitions of constipation included both a patient-centred perspective and the description of particular symptoms associated with constipation. Older participants defined constipation in terms of frequency of bowel movements and changes in normal bowel routine. Older participants perceived constipation as follows: linked to specific diseases, medical conditions or health problems; caused by the consumption of specific medications or surgical procedures; caused by diet or eating habits; part of the ageing process; due to not going to the toilet when having the urge to defecate; hereditary; caused by stress or worry; and caused by environmental exposure. GP participants suggested that constipation is due to changes in diet and lifestyle; the physiology and degenerative processes of ageing; and the iatrogenic impact of opiate medications. Nurse participants identified that constipation is linked to decreased mobility, decreased food intake, decreased fluid intake and consumption of certain medications. For many older people their constipation emerged as a problem over a period of time; for some the 'condition' had existed for many years. Self-management of constipation had typically been their first response to the symptoms and continued once professional help had been sought. Older participants had a wide experience of different management strategies and treatments for constipation, and at the time of the study had firm preferences about the laxatives they would use. GP participants recognised the experience and use of laxatives of their patients. They exhibited strong personal preferences for different laxatives, often prescribing them in combination. Nurses were more likely than GPs to treat and prevent constipation using non-laxative measures; these included providing advice on appropriate dietary changes, increasing fluid intake and, if possible, encouraging exercise and mobility. CONCLUSIONS: There is little shared understanding between patients and professionals about 'normal' bowel function with little consensus in general practice of the optimum management strategies for chronic constipation and the most effective strategies to use. Chronic constipation is seen as less important than other conditions prevalent in general practice (e.g. diabetes) because it is not an agreed management target within national frameworks. Consequently, practitioners had little interest in constipation as a research topic. Patient preferences and the absence of patient equipoise formed an enormous barrier to the recruitment of patients in the implementation of this trial. Studies are needed to investigate different methods of recruitment within the constraints of current ethical guidelines on 'opting in' and to identify barriers and facilitators to recruitment to complex trials in general. Patient preference trials and natural cohort observational studies are also needed to investigate the effectiveness or cost-effectiveness of different laxatives and treatment strategies in the management of chronic constipation.

Swallowing beyond six years post (chemo)radiotherapy for head and neck cancer; a cohort study.

OBJECTIVE: The objective of this prospective study is to report on long-term swallowing outcomes in a group of head and neck cancer patients following (chemo) radiotherapy treatment, assess for changes over time and identify any predictor variables of outcome. MATERIALS AND METHODS: 42 survivors were assessed on four swallowing measures and followed up from pre-treatment to six years post 3D (chemo) radiotherapy. Measures included a swallowing specific QOL questionnaire, penetration-aspiration scale, dietary restrictions and a timed water swallow test. RESULTS: At six years, 71% reported swallowing difficulties on the questionnaire. One fifth of patients had aspiration, with a raised risk of chest infection. Seven percent required a laryngectomy for a dysfunctional larynx. Despite this, half the group reported having a normal diet. There was variation in the pattern of change between one and six years. A significant deterioration was only observed in the timed water swallow test (p < 0.0001). Larger radiotherapy volume predicted this outcome. None of the variables tested predicted outcome for the other three swallow measures. CONCLUSION: Patients continue to report swallowing difficulties at six years, with a proportion having persistent aspiration. Further work on identifying the risk factors associated with aspiration tolerance, aspiration pneumonia, prevention and management is warranted. Long-term dysphagia remains a significant and serious concern following (chemo) radiotherapy for HNC and swallowing outcomes should continue to be monitored over time.