Yes / Social isolation in older adults is associated with morbidity. Evaluating interventions to promote social engagement is a research priority. Methods: A parallel-group randomised controlled trial was planned to evaluate whether telephone friendship (TF) improves the well-being of independently living older people. An internal pilot aimed to recruit 68 participants by 30 September 2012, with 80% retained at 6 months. Randomisation was web based and only analysts were blind to allocation. A service provider was contracted to train 10 volunteer facilitators by 1 April 2012 and 10 more by 1 September 2012. Participants were aged > 74 years with good cognitive function and living independently in an urban community. The intervention arm of the trial consisted of manualised TF with standardised training: (1) one-to-one befriending (10- to 20-minute calls once per week for up to 6 weeks made by volunteer facilitators) followed by (2) TF groups of six participants (1-hour teleconferences once per week for 12 weeks facilitated by the same volunteer). Friendship groups aimed to enhance social support and increase opportunities for social interaction to maintain well-being. This was compared with usual health and social care provision. The primary clinical outcome was the Short Form questionnaire-36 items (SF-36) mental health dimension score at 6 months post randomisation. Qualitative research assessing intervention acceptability (participants) and implementation issues (facilitators) and an intervention fidelity assessment were also carried out. Intervention implementation was documented through e-mails, meeting minutes and field notes. Acceptability was assessed through framework analysis of semistructured interviews. Two researchers coded audio recordings of telephone discussions for fidelity using a specially designed checklist. Results: In total, 157 people were randomised to the TF group (n = 78) or the control group (n = 79). Pilot recruitment and retention targets were met. Ten volunteers were trained by 1 September 2012; after volunteer attrition, three out of the 10 volunteers delivered the group intervention. In total, 50 out of the 78 TF participants did not receive the intervention and the trial was closed early. A total of 56 people contributed primary outcome data from the TF (n = 26) and control (n = 30) arms. The mean difference in SF-36 mental health score was 9.5 (95% confidence interval 4.5 to 14.5) after adjusting for age, sex and baseline score. Participants who were interviewed (n = 19) generally declared that the intervention was acceptable. Participant dissatisfaction with closure of the groups was reported (n = 4). Dissatisfaction focused on lack of face-to-face contact and shared interests or attitudes. Larger groups experienced better cohesion. Interviewed volunteers (n = 3) expressed a lack of clarity about procedures, anxieties about managing group dynamics and a lack of confidence in the training and in their management and found scheduling calls challenging. Training was 91–95% adherent with the checklist (39 items; three groups). Intervention fidelity ranged from 30.2% to 52.1% (28–41 items; three groups, three time points), indicating that groups were not facilitated in line with training, namely with regard to the setting of ground rules, the maintenance of confidentiality and facilitating contact between participants. Conclusions: Although the trial was unsuccessful for a range of logistical reasons, the experience gained is of value for the design and conduct of future trials. Participant recruitment and retention were feasible. Small voluntary sector organisations may be unable to recruit, train and retain adequate numbers of volunteers to implement new services at scale over a short time scale. Such risks might be mitigated by multicentre trials using multiple providers and specialists to recruit and manage volunteers. / Funding for this study was provided by the Public Health Research programme of the National Institute for Health Research.

This study investigates the prevalence of peri-operative anxiety and the effective management of intra-operative anxiety during awake surgery. Plastic and vascular surgical patients were selected for the study as many procedures performed within these specialities are performed under local or regional anaesthesia. The study consists of two distinct stages. The first stage was a postal survey of patients (n=213) who had undergone awake plastic, renal access or carotid surgery up to two weeks previously, in order to determine retrospectively the prevalence of peri-operative anxiety. The second stage of the study was a randomised controlled trial of interventions for the effective management of intra-operative anxiety in patients (n=128) having undergone the same surgical procedures described in stage one. The interventions tested in stage two were handholding and an anxiety management package involving a relaxation technique and a procedural information leaflet, against a 'usual care' control. The findings from stage one of the study suggest that peri-operative anxiety prevalence is low, although unacceptable levels of anxiety are seen to elevate during the intra-operative phase. The RCT in stage two demonstrated that intra-operative anxiety was no more effectively managed by the interventions tested than by usual care alone. The validity and reliability of retrospective anxiety measurement was investigated by comparing anxiety scores from stage one with contemporaneous and post-hoc anxiety scores from stage two and found to be an accurate measure of anxiety experienced at the time of the event.

Background: Although physical inactivity has been linked with numerous chronic health conditions and overall mortality, the majority of English adults report insufficient physical activity. To increase population physical activity levels, researchers have called for more community-level interventions. To evaluate these complex public health interventions, innovative study designs are required. The aim of this thesis was to evaluate whether a community-level physical activity intervention—‘Devon Active Villages’—increased the activity levels of rural communities. Methods: The Devon Active Villages intervention provided villages with 12 weeks of physical activity opportunities for all age groups. Community engagement helped tailor activity programmes for each village; communities were then supported for a further 12 months. 128 rural villages from south-west England were randomised to receive the intervention in one of four time periods, as part of a stepped wedge cluster randomised controlled trial. Data collection consisted of a postal survey of a random sample of adults (≥18 years), at baseline, and after each of the four intervention periods. The primary outcome of interest was the proportion of adults who reported sufficient physical activity to meet the current guidelines (≥150mins of moderate-and-vigorous, or ≥75mins of vigorous-intensity activity per week). The number of minutes spent in moderate-and-vigorous activity per week was analysed as a secondary outcome. Using data from all five periods, a comparison of study outcomes between intervention and control arms was performed, allowing for time period (as a fixed effect), and the random effect induced by correlation of outcomes (clustering) within villages. Additionally, the baseline data were analysed separately using logistic and linear regression models to examine the correlates of physical activity behaviour in rural adults. Results: Baseline study: 2415 adults completed the postal survey (response rate 37.7%). The following factors both increased the odds of meeting the recommended activity guidelines and were associated with more leisure-time physical activity: being male, in good health, greater commitment to being more active, favourable activity social norms, greater physical activity habit, and recent use of recreational facilities. In addition, there was evidence that younger age, lower body mass index, having a physical occupation, dog ownership, inconvenience of public transport, and using recreational facilities outside the local village were associated with greater reported leisure-time physical activity. Main study: 10,412 adults (4693 intervention, 5719 control) completed the postal survey (response rate 32.2%). The intervention did not increase the odds of adults meeting the physical activity guideline, although there was weak evidence of an increase in the minutes of moderate-and-vigorous-intensity activity per week. The ineffectiveness of the intervention may have been due to its low penetration—only 16% of intervention participants reported being aware of the intervention, and just 4% reported participating in intervention events. Conclusions: Baseline study: This study highlights potentially important correlates of physical activity that could be the focus of interventions targeting rural populations, and demonstrates the need to examine rural adults separately from their urban counterparts. Main study: A community-level physical activity intervention providing tailored physical activity opportunities to rural villages did not improve physical activity levels in adults. Greater penetration of such interventions needs to be achieved for them to have any chance of increasing the prevalence of physical activity at the community level.

There are no large-scale outcome studies of music therapy in secure hospital settings for people who have committed serious offences. These patients have a right to expect evidence-based multi-disciplinary treatment (Duggan et al. 2006); NICE (2010). Music therapy therefore should take a form which can be integrated into the treatment pathway. A single site implementation of a mixed-methods patient preference randomised controlled trial investigated the clinical effectiveness of a manualised music therapy model called Group Cognitive Analytic Music Therapy (G-CAMT). This context-specific, time limited intervention incorporates theories from Group Analysis (Foulkes 1964) and Cognitive Analytic Therapy (Ryle and Kerr 2003). The central research question was ‘Is G-CAMT feasible and effective for offenders in a secure multi-disciplinary treatment setting?’ The research process followed the Medical Research Council framework for developing and evaluating complex interventions (Campbell et al. 2000, 2007). Twenty patients were recruited; those expressing no preference were randomised to treatment or control arms. The two music therapists and the principal investigator were masked to their allocation status. Those in the treatment arm were allocated to one of two treatment groups of five, each run individually by one of the music therapists. Each group had sixteen ninety minute weekly sessions with followup at eight weeks. Treatment and control groups received standard care. The primary measure was the Person’s Relating to Others Questionnaire (Birtchnell and Evans 2004) Secondary measures were the Basic Empathy Scale (Jolliffe and Farrington 2006a), The Multi-Scale Dissociation Inventory (Briere, 2002) and an observational measure, the Chart of Interpersonal Reactions in Closed Living Environments (Blackburn and Glasgow, 1993). Quantitative data from these measures were examined for associations with qualitative data from semi-structured interviews administered to the music therapists and analyzed using Interpretative Phenomenological Analysis (Smith et.al. 2009) Findings from the results of the primary measure demonstrated statistically significant (Mann Whitney U: p<.05) reductions in favour of the treatment group compared to the control, in intrusive, restrictive and possessive behaviors and helpless or self-denigrating behaviours. There were improvements over time within the treatment group in the domains of sociability and hostility (Friedman Test :p<.04). The use of a manual was shown to help the music therapists manage the risk of violence without constraining their creativity. Two years after the end of the treatment 78% of treatment participants had moved to conditions of lower security over a mean period of 19 months compared with 66% of control subjects over a mean period of 25.5 months. The thesis concludes by situating G-CAMT amongst contemporary music therapy models.

Master of Science / Haematopoietic stem cell transplantation (HSCT) is a complicated and high-risk procedure used to cure disease or stop the spread of disease in a range of cancers. HSCT carries a high incidence of mortality and is associated with distressing short and long-term side effects. In addition, patients remain at risk of recurrence or mortality years after transplantation. Therefore, patients undergoing HSCT have been found to experience significant emotional and psychosocial distress because of the trauma associated with treatment. The literature suggests that about 50% of HSCT patients will experience clinical levels of distress. Carers and family members play an important role in caring for these ill patients in the short and long-term. Major role changes and financial stressors are experienced in many families, adding to the burden of care. However, very little is known about the rates of psychopathology in carers of HSCT patients. Due to the arduous nature of HSCT, psycho-educational programmes have been developed by major transplant centres and hospitals in order to provide HSCT patients and their families with information on the treatment process, side effects, risks, and long-term outcomes. Research on patient education in oncology has shown that providing patients and carers with information about their illness and treatment reduces anxiety and distress. To date, there have been no empirical evaluations to support the use of education programmes for HSCT patients. While it could be assumed that information would be helpful in reducing anxiety and depression in HSCT as it is in oncology generally, the information provided to these patients is usually more confronting and therefore, may be less reassuring. Thus, it is not known whether providing patients with education about HSCT reduces patient and carer distress or whether it might actually increase adverse outcomes. The aim of the present study was to evaluate the rates and correlates of distress in carers and patients and examine the effect of a psychoeducation programme for patients undergoing HSCT and their carers on knowledge, distress, information satisfaction, social support and caregiver burden. A randomised control trial was conducted to provide empirical data in relation to the latter aim. The following hypotheses were proposed. Firstly, it was hypothesised that patients and carers who received the education programme would have higher levels of knowledge, not evidenced in a group waiting to receive the programme. Secondly, it was hypothesised that the education program would not lead to increased anxiety and depressive symptoms. Thirdly, patients who know more about their condition would be the least distressed. As predicted, this study found high levels of distress, particularly in carers. Higher patient distress was related to having more concern about one’s illness and experiencing more symptoms. Education was effective in increasing patient and carer knowledge. Importantly there were no adverse effects of knowledge and greater patient knowledge following the education program was associated with less distress, although there was no direct effect of education on distress. Future research should aim to identify what aspects of the education program are helpful to patients. Finally, support interventions such as CBT are needed to help patients and carers, in particular, cope with the high levels of distress inherent in the HSCT experience.

The increased work of breathing associated with intense cycling has been identified as a factor that may negatively affect cycling performance. The aerodynamic position, abnormal respiratory mechanics either at rest or during exercise, and the development of a tachypnoeic breathing pattern are factors known to increase the work of breathing. Breathing pattern retraining aims to decrease the work of breathing by delaying the onset of dynamic hyperinflation and the recruitment of accessory breathing muscles. To date no studies have investigated the performance, physiological and perceptual consequences of manipulating breathing pattern in trained cyclists. Purpose: The aim of the present study was to investigate the effect of breathing pattern retraining on 20-km time trial performance and respiratory and metabolic measures in competitive cyclists. Method: Twenty-four competitive male cyclists (age 37.7 ± 8.6 years, mean ± SD; peak 4.34 ± 0.47 L·min-1) were match paired on 20-km time trial performance and assigned at random to either an intervention group (breathing pattern retraining; N = 12) or control group (N = 12). 20-km time trial performance, pulmonary function and the physiological and perceptual response during a maximal incremental cycle step test were assessed pre- and post-intervention. The intervention group underwent four weeks of specific breathing pattern retraining using exercises designed to reduce dynamic hyperinflation and optimise respiratory mechanics. The control group attended the laboratory once a week during this period and performed a 10 minute sub-maximal ride wearing a biofeedback breathing harness. The control group was led to believe the purpose for their participation was to investigate the effect that maximal exercise had on breathing pattern, and to test the reliability of the breathing harness. There was no attempt to modify the breathing pattern of the control group. Data were analysed using an MS Excel spreadsheet designed for statistical analysis. The uncertainty in the effect was expressed as 90% confidence limits and a smallest worthwhile effect of 1.0% was assumed. Results: The intervention group showed substantial improvements in 20-km time trial performance (-1.5 ± 1.1%) and incremental power (3.2 ± 3%). Additionally, breathing frequency (-13.2 ± 8.9%; -9.5 ± 8.4%), tidal volume (10.6 ± 8.5%; 9.4 ± 7.6%), inspiratory time (10.1 ± 8%; 9.4 ± 7.7%), breathing RPE (-30 ± 33.9%; -24.7 ± 28.1%) and leg RPE (-27.9 ± 38.5%; -24.7 ± 28.2%) were all positively affected at lactate threshold and lactate turn point. No positive changes were observed in the control group for 20-km time trial performance (0.0 ± 1.0%), incremental power (-1.4 ± 3.5%), breathing frequency (-1.6 ± 8.0%; -2.0 ± 7.9%), tidal volume (0.9 ± 7.2%; 2.9 ± 9.4%), breathing RPE (16.1 ± 50.2%, 24.8 ± 43%) or leg RPE (13.4 ± 39.6%; 19.9 ± 43.2%) . Conclusion: These results provide evidence of the performance enhancing effect of four weeks of breathing pattern retraining in cyclists. Furthermore, they suggest breathing pattern can be retrained to exhibit a controlled pattern, without a tachypnoeic shift, during high intensity cycling. Additionally, these results indicate breathing pattern retraining attenuates the respiratory and peripheral perceived effort during incremental exercise. Key words: Breathing pattern disorders, retraining, blood stealing, cycling, performance, power output, respiratory mechanics, perceived exertion, 20km-TT

Background: Physiological studies have shown that many preterm infants and infants with chronic lung disease may suffer chronic hypoxaemia, which possibly leads to poor growth and development. Anecdotal reports indicate that there is a drive to increase the oxygen saturation target range to a higher level in these infants due primarily to perceived benefits derived from clinical experience and from uncontrolled observational studies of babies discharged on home oxygen. Objective The BOOST (Benefits Of Oxygen Saturation Targeting) trial is the first randomised trial to assess the long-term benefits and harms of two different oxygen saturation target ranges. Methods: BOOST was a multicentre, double blinded, randomised controlled trial that enrolled 358 infants born at less than 30 weeks� gestation who remained oxygen-dependent at 32 weeks postmenstrual age. They were randomly assigned to target either a functional oxygen saturation range of 91-94% (standard or control group) or 95-98% (higher or treatment group). The primary outcomes were growth and neurodevelopmental measures at 12 months corrected age. Secondary outcomes included length of hospital stay, retinopathy of prematurity, health service utilisation, parental stress, and infant temperament. Results: Prognostic baseline characteristics did not differ between the two groups. Mean birth weight and gestational age of enrolled infants was 917g and 26.5 weeks respectively. The rate of antenatal corticosteroid use was 83%.

Preventive care for the elderly originated with a study in Great Britain in 1964 that reported a large number of unmet health needs in the elderly and advocated early intervention. Subsequent randomised controlled trials (RCT) used a broad assessment of health including bio-medical, functional, psychological and social /environmental components but inconsistently demonstrated improved outcome for the elderly. 'Health checks' were introduced for all patients in British general practice in 1990. European and American models of care evolved similarly and justify a multidisciplinary team assessment, thorough training of assessment staff and medical supervision of recommendations. Two literature reviews published in 2000 have not reported sound evidence in favour of health assessments. Medicare funding of health assessments for the Australians aged 75 years and over was introduced in November 1999. A protocol for conducting 75+ Health Assessment (75+ HA) was developed and a pilot study was conducted in Yarrawonga in 1995 to initiate Australian research of this model of care. A RCT in the Adelaide Western Division of General Practice tested this model of care. The intervention group (n=50) had two 75+ HA one year apart. The control group (n=50) was left to usual care and had a 75+ HA one year later. Demographic data and the Short Form-36 were used to ensure both groups were comparable. Primary outcome measures did not demonstrate statistically significant reduction in problems nor mortality in the intervention (75+ HA) group compared to the control group. Significant improvements in secondary outcome measures in the intervention group were in self-rated health, depression score and decreased numbers reporting falls. 75+ HAs have been widely taken up by Australian general practitioners. It is no longer possible to conduct a RCT due to the inability to find a legitimate control group. Recommendations arising form this literature review and RCT include; evaluation studies of 75+ HA, concentration on a functional model of health and that nurses or allied health professionals should conduct the assessment in the elderly person's home. A consistent framework for analysis of 75+ HA is proposed. The elderly can be conceived to occupy one of 3 cohorts defined by their function state: No impairment of Activities of Daily Living (ADL), Impairment of Instrumental ADL only or Impairment of Basic ADL. The elderly without ADL impairment have not been demonstrated to benefit from 75+ HA and should be left to access the acute care stream of health services. The most disabled elderly with Basic ADL impairment have not consistently been shown to benefit from 75+ HA probably because they need a more intense level of community care. They should have Care Plans renewed regularly, as tested in the Australian Coordinated Care Trials. The cohort with Instrumental ADL impairment only seems most likely to benefit from annual 75+ HA. An evaluation of screening the elderly for Instrumental and Basic ADL impairment and providing appropriate services for each cohort is recommended. / Thesis (M.D.)--Department of General Practice, 2001.

Stress management interventions (SMIs) are increasingly used by organisations across both private and public settings. Such interventions are employed with the expectation that they will be effective in reducing levels of stress in participants and in turn, will provide a return to the organisation by way of increased productivity through performance improvements of those employees whose stress has been reduced. Despite the increasing popularity of SMIs, there exists a lack of evidence on whether they have any effect on the performance of users, and on the relative effectiveness of the components that often make up SMIs. Although the literature addressing SMIs and their effects is increasing, relatively few studies directly compare different techniques, and even fewer employ randomised controlled designs or follow-up measures. The assumed relationship between the reduction of stress and improvement of managerial performance does not appear to have been tested with a randomised controlled trial. The term “stress” as used in this study specifically denotes the concept of “distress” as defined by Selye (1956; 1987). To support this use of the term, the evolution of current terminology in the field of occupational stress is briefly discussed with specific reference to the development and influence in the wider literature of the Yerkes Dodson Law (Yerkes, 1909). The aims of this thesis were to (1) compare the relative effectiveness of two component techniques often used in SMIs (somatic and cognitive techniques) in the reduction of stress, and (2) to examine the effect of the use of these techniques on the performance of managers in their workplace. Study One was a randomised controlled trial assessing the effect of the use of somatic and cognitive stress management interventions on stress and performance in managers. Participants were 112 corporate managers who were randomly assigned to one of two intervention groups (somatic or cognitive technique training) or to a wait list control group. The intervention groups were trained in their respective techniques over a 4 week period in brief (20-30 minute) face-to-face workshop sessions. Participants were provided with recordings of the techniques to assist practice between training sessions. At baseline, stress was assessed using the Occupational Stress Inventory – Revised Edition (OSI-R, Osipow, 1998), and managerial performance was assessed with the Personal Qualities Competency from the Inventory of Management Competencies (IMC, Saville Holdsworth Ltd., 1993). In the case of the IMC, self, colleague, and subordinate assessments were used. On completion of the 4 week intervention, the OSI-R was readministered, and then at week 12 and week 24, follow-up assessments of stress and managerial performance took place. At the week 12 follow-up, MANOVA for the OSI-R showed no significant difference between the somatic and cognitive interventions in their effect on stress, although both interventions did reduce stress relative to the wait list control group, as measured by the OSI-R. A significant intervention effect was also shown (ηp2 = 0.089, p = 0.002) for the combined intervention groups (cognitive and somatic). MANOVA for the Personal Qualities Competency showed a significant intervention effect for the self (ηp2 = 0.077, p = 0.008) and colleague (ηp2 = 0.064, p = 0.013) assessments, and a no significant effect (ηp2 = 0.032, p = 0.063) for the subordinate assessment at the week 12 follow-up point. Unfortunately, withdrawal and attrition reduced the sample size below that required for analysis at the week 24 follow-up point. Study Two was designed as a follow-up qualitative study that aimed to gather information on participants’ perceptions of the effects of the interventions on their stress and performance, and of their reasons for completion or no completion of the SMI. In this study, 14 participants from Study One took part in semi-structured interviews after the final follow-up assessment (week 24) for that study. The interviews were structured to elicit responses concerning participants’ perceptions of the demands of their workplace and their stress, their experience of using the stress management techniques (including perceived benefits or behavioural changes from that use), their reasons for completion or no completion of the intervention, and their own definitions of stress. Several important findings emerged from this study. First, participants described their workplace as characterised by high pressure and demand with rapid change and a perceived lack of personal control. Second, participants who continued to use the techniques they had learned after the formal intervention was completed did so because they perceived personal benefits in terms of their ability to relax and in terms of their perceptions of workload and demand. For those who did not complete the intervention, the predominant reasons reported for no completion were workplace task demands, lack of top management commitment to an intervention of this nature, and lack of personal gain once the techniques had been learned. In relation to defining stress, participants did not have agreement, but rather reported definitions reflecting a multifaceted complex amalgam of physiological, psychological, and emotional aspects. Research such as this is important in terms of its contribution to the general field of occupational stress and its alleviation. It addresses a long-standing need to assess the relative effectiveness of some of the subcomponents commonly employed as part of more complex multifaceted approaches to SMIs, and the effect of the techniques on both stress and performance. This thesis makes several contributions to existing knowledge. First, this thesis clarifies the origin of the Yerkes Dodson Law and its relevance to current stress management thinking. In management texts distress has come to be regarded as too much stress or pressure. This is coupled with the idea that some stress has a positive impact on performance due to an earlier and erroneous interpretation of the Yerkes Dodson Law. Second, Study One provides evidence of the relative effectiveness of two different SMI components in the reduction of individuals’ occupational stress, as well as evidence for the effectiveness of individual focussed SMIs in the reduction of stress in corporate managers. Third, Study One provides evidence for a positive effect on managers’ performance consequent to their use of stress management techniques. This thesis also sheds light on managers’ definitions of stress, and their reasons for completion or no completion of SMIs. In summary, individual focussed (or secondary) SMIs have the potential to reduce stress and to improve performance in corporate managers as perceived by both the individual and others in the workplace.

Aims: To introduce the concepts “quality assurance”, “rational drug prescribing” and “outreach visits” in general practice in Storstrøm County, Denmark and study the effect of unsolicited mailed feedback and outreach visits on drug prescribing. Methods: The first step was to generate standardised charts displaying the county variations of drug volume prescribing within 13 major drug groups at the second ATC-level. The charts were mailed unsolicited to the 94 general practices in the county. Each practice could identify its position within the county prescribing variation. This procedure was repeated every six months from 1992 to 1998. In 1998 annual outreach visit were offered to general practice and 88 of 94 practices accepted. The awareness of prescribing profiles was monitored during the visits in 1998 and 1999. In 2000 a randomised controlled trial allocating practices into two parallel arms was launched. Effects of two desk guides on rational drug prescribing promoted during outreach visits were evaluated. Results: During the period of mailed feedback, there was a large variation in drug prescribing volumes between practices but little within-practice variation over time. No significant change was detected. Practitioners’ assessment of their own prescribing profiles improved significantly through the outreach visits. The prescribing of antibiotics was significantly affected by the desk guide whereas no effect was detected on the prescribing of non-steroid anti-inflammatory drugs. Conclusions: Semi-annually mailed feedback over a seven-year period had no significant effect on prescribing volumes or variations in prescribing volumes, but some effect on the practitioners’ awareness of their own prescribing profiles. Outreach visits significantly improved the awareness. A randomised controlled trial using outreach visits combined with a simple desk guide affected the prescribing of some antibacterial drugs as intended whereas the similar intervention had no detectable effect on the prescribing of non-steroid anti-inflammatory drugs.