Yes / Randomised controlled trials of non-pharmacological interventions in children's therapy are rare. This is, in part, due to the challenges of the acceptability of common trial designs to therapists and service users. This study investigated the acceptability of participation in cluster randomised controlled trials to therapists and service users. A national electronic survey of UK occupational therapists, physiotherapists, speech and language therapists, service managers, and parents of children who use their services. Participants were recruited by NHS Trusts sharing a link to an online questionnaire with children's therapists in their Trust and with parents via Trust social media channels. National professional and parent networks also recruited to the survey. We aimed for a sample size of 325 therapists, 30 service managers, and 60 parents. Trial participation was operationalised as three behaviours undertaken by both therapists and parents: agreeing to take part in a trial, discussing a trial, and sharing information with a research team. Acceptability of the behaviours was measured using an online questionnaire based on the Theoretical Framework of Acceptability constructs: affective attitude, self-efficacy, and burden. The general acceptability of trials was measured using the acceptability constructs of intervention coherence and perceived effectiveness. Data were collected from June to September 2020. Numerical data were analysed using descriptive statistics and textual data by descriptive summary. A total of 345 survey responses were recorded. Following exclusions, 249 therapists and 40 parents provided data which was 69.6% (289/415) of the target sample size. It was not possible to track the number of people invited to take the survey nor those who viewed, but did not complete, the online questionnaire for calculation of response rates. A completion rate (participants who completed the last page of the survey divided by the participants who completed the first, mandatory, page of the survey) of 42.9% was achieved. Of the three specified trial behaviours, 140/249 (56.2%) therapists were least confident about agreeing to take part in a trial. Therapists (135/249, 52.6%) reported some confidence they could discuss a trial with a parent and child at an appointment. One hundred twenty of 249 (48.2%) therapists reported confidence in sharing information with a research team through questionnaires and interviews or sharing routine health data. Therapists (140/249, 56.2%) felt that taking part in the trial would take a lot of effort and resources. Support and resources, confidence with intervention allocation, and sense of control and professional autonomy over clinical practice were factors that positively affected the acceptability of trials. Of the 40 parents, twelve provided complete data. Most parents (18/40, 45%) agreed that it was clear how trials improve children's therapies and outcomes and that a cluster randomised trial made sense to them in their therapy situation (12/29, 30%). Using trials to evaluate therapy interventions is, in principle, acceptable to therapists, but their willingness to participate in trials is variable. The willingness to participate may be particularly influenced by their views related to the burden associated with trials, intervention allocation, and professional autonomy. / The study was funded and supported by the UK Occupational Therapy Research Foundation, a division of the Royal College of Occupational Therapists, as part of the 2018–2021 Research Priority Grant.

No / Newcastle Upon Tyne Hospitals NHS Foundation Trust

This thesis describes the development of methods for automatically obtaining coarse gaze direction estimates for pedestrians in surveillance video. Gaze direction estimates are beneficial in the context of surveillance as an indicator of an individual's intentions and their interest in their surroundings and other people. The overall task is broken down into two problems. The first is that of tracking large numbers of pedestrians in low resolution video, which is required to identify the head regions within video frames. The second problem is to process the extracted head regions and estimate the direction in which the person is facing as a coarse estimate of their gaze direction. The first approach for head tracking combines image measurements from HOG head detections and KLT corner tracking using a Kalman filter, and can track the heads of many pedestrians simultaneously to output head regions with pixel-level accuracy. The second approach uses Markov-Chain Monte-Carlo Data Association (MCMCDA) within a temporal sliding window to provide similarly accurate head regions, but with improved speed and robustness. The improved system accurately tracks the heads of twenty pedestrians in 1920x1080 video in real-time and can track through total occlusions for short time periods. The approaches for gaze direction estimation all make use of randomised decision tree classifiers. The first develops classifiers for low resolution head images that are invariant to hair and skin colours using branch decisions based on abstract labels rather than direct image measurements. The second approach addresses higher resolution images using HOG descriptors and novel Colour Triplet Comparison (CTC) based branches. The final approach infers custom appearance models for individual scenes using weakly supervised learning over large datasets of approximately 500,000 images. A Conditional Random Field (CRF) models interactions between appearance information and walking directions to estimate gaze directions for head image sequences.

Thesis (DPhil (Psychology))—University of Stellenbosch, 2009. / ENGLISH ABSTRACT: Extensive research over the past 30 years has shown that reliable, sensitive, responsive and empathic care of the infant by the mother or mother-substitute in the early months facilitates the development of secure attachments in infants, and ultimately their healthy development towards competent adulthood and future relationships with others. This study analyses interviews with 17 mothers selected from an intervention proven successful by means of a randomized controlled trial. The intervention took place in Khayelitsha, a peri-urban settlement close to Cape Town, South Africa, and was delivered by previously untrained lay counsellors to at risk mothers and infants. Supervision and training of the counsellors was provided by the author. Mothers were purposively selected on the basis of being experienced by counsellors as easy, difficult to reach, young/immature mothers and HIV-positive mothers, and were interviewed by a clinically trained interviewer not involved in the project individually and in groups. Counsellors’ process notes, exploring the impact, relevance and meaning that the intervention had for the recipient mothers, as well as the supervisor’s notes were also used as data. The findings identify what changes mothers reported, their experiences of the intervention, cultural issues in the intervention, and mothers’ suggestions for modifications to the programme. The results are discussed in light of theories of change emerging from the literature on psychotherapy change research and research on community-based interventions. The study shows that though results of randomized controlled trials are necessary for policy planning, in-depth interrogation of the design and process issues at stake in complex community-based studies yield complementary data which are also important to consider. Finally, the study considers the implications of this understanding of process for the future dissemination of the training and application of this programme, as well as policy, research and funding challenges. / AFRIKAANSE OPSOMMING: Wydstrekkende, uitgebreide navorsing van die afgelope 30 jaar toon dat betroubare, sensitiewe, aandagtige en empatiese sorg vir die peuter deur die moeder of moeder-plaasvervanger, die vorming van veilige bindings, sowel as die uiteindelike gesonde ontwikkeling van bevoegde volwassenheid en toekomstige verhoudings met andere fasiliteer. Hierdie studie analiseer onderhoude met 17 moeders, gekies uit 'n intervensie wat bewys is deur middel van 'n ewekansige kontrole toetsing. Die intervensie het plaasgevind in Khayelitsha, 'n peri-stedelike nedersetting naby Kaapstad, Suid-Afrika, en is uitgevoer deur voorheen onopgeleide vrywilliger beraders wat moeders en peuters wat blootgestel is aan risiko bedien. Supervisie en opleiding van die beraders is deur die outeur voorsien. Moeders is vooraf uitgekies deur die beraders, volgens die criteria: maklik en moeilik bereikbaar, jong/onvolwasse moeders, en HIV positiewe status. 'n Klinies opgeleide onderhoudvoerder wat onbetrokke is by die res van die projek het met die moeders individueel en in groepskonteks onderhoude gevoer. Beraders se prosesnotas wat die impak, relevansie en betekenis van wat die invervensie vir die moeders ingehou het, sowel as die supervisor se notas is ook gebruik as data. Die bevindings is bespreek in die lig van veranderingsteorieë wat uit die literatuur oor psigoterapie veranderingsnavorsing, sowel as navorsing oor gemeenskapsgebaseerde intervensies vorendag gekom het. Die studie toon dat hoewel bevindings van ewekansige kontrole toetsing nodig is vir beleidsbeplanning, in-diepte ondersoek van die proses en ontwerp kwessies ter sake in komplekse gemeenskapsgebaseerde studies komplimentêre data lewer wat ook belangrik is om in ag te neem. Ten laaste oorweeg die studie die implikasies van hierdie ondersoek van proses vir toekomstige disseminasie van die opleiding en toepassing van hierdie program, sowel as beleid, navorsing en befondsings uitdagings.

Background: Breast cancer is the most frequently diagnosed cancer and a leading cause of cancer death among females, both worldwide and in the UK. Although, UK incidence of breast cancer is rising, breast cancer mortality rates are falling, due largely to early detection and improved treatment. As a result there are more women living with a diagnosis of breast cancer than ever before. Due mainly to side-effects of adjuvant therapy, breast cancer patients may require diagnostic, therapeutic, supportive or palliative services many years post-diagnosis, which poses a major challenge to already stretched healthcare services. Accordingly, effective and inexpensive interventions that can alleviate treatment side-effects, improve health, quality of life and potentially reduce risk of early mortality are required for breast cancer patients. Awareness of the positive influence that physical activity can have on breast cancer development and outcome is an important determinant of physical activity levels. A higher level of physical activity before and after breast cancer diagnosis is related to a lower risk of all-cause and breast cancer-related mortality. Randomised controlled trials have reported beneficial effects of physical activity interventions on outcomes relating to health, quality of life and mortality risk among breast cancer survivors. Aims: The present project aimed to: 1) assess awareness of the role of physical activity on breast cancer risk and the sufficiency of physical activity undertaken in women attending the NHS breast screening programme (NHSBSP), 2) compare physical activity levels of women at different stages of breast cancer pathway, 3) investigate the effects of a low-cost six-month home-based physical activity intervention on physical activity, body mass, health-related quality of life (HRQoL), insulin resistance and blood lipid profiles of breast cancer survivors and 4) assess the effects of our home-based intervention on cardiorespiratory fitness in a subset of breast cancer survivors. Methods: A total of 309 volunteers (188 NHSBSP attendees, 41 breast cancer patients undergoing chemotherapy and 80 post-treatment breast cancer survivors) participated in the current project. Physical activity was assessed via the International Physical activity Questionnaires (IPAQ). In studies one and two, Body mass and body mass index (BMI) were assessed directly in chemotherapy patients and breast cancer survivors, and indirectly from self-reported values in NHSBSP attendees. While in study three, body fat percentage was measured via bioelectrical impedance analysis, HRQoL was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire and fasting blood samples were taken to measure lipid, glucose and insulin concentrations at baseline and post-six month home-based physical activity intervention. In study four, a random subsample of 32 breast cancer survivors undertook an exercise tolerance test to establish peak oxygen uptake values. Results: A high proportion (70%) of NHSBSP attendees engaged in low-moderate levels of physical activity and performed low amounts of recreational physical activity. Attendees demonstrated high awareness (75%) of the role of physical activity in reducing breast cancer risk but those categorised as “low activity” were significantly unaware of insufficiency of activity (p<0.05). Chemotherapy patients and breast cancer survivors had significantly lower levels of total physical activity than NHSBSP attendees (p<0.001 and p<0.05, respectively). The randomised controlled trial revealed significant improvements in total physical activity, body mass (p<0.05), BMI (p<0.05) HRQoL (breast cancer subscale, p<0.01; trial outcome index, p<0.05) and total (p<0.01) and low-density lipoprotein (p<0.05) cholesterol concentrations in the intervention group compared to usual care, and significant improvements in cardiorespiratory fitness (p<0.05) in a subsample of breast cancer survivors allocated to intervention. Conclusions: Physical activity interventions that incorporate strategies aimed at increasing awareness of recommended physical activity guidelines may be required in populations at risk of breast cancer. A relatively large proportion of women at risk of breast cancer may not be sufficiently exposed to the potential benefits of physical activity on breast cancer outcomes. Post-treatment breast cancer patients may be more receptive to physical activity interventions as the negative effects of chemotherapy begin to resolve, and therefore, may benefit from physical activity interventions. Results suggest that a low-cost home-based physical activity intervention with counselling and telephone support can improve the health and HRQoL of breast cancer survivors, which may in turn potentially reduce risk of breast cancer and cardiovascular disease-related mortality. Given the encouraging results and its highly portable and feasible nature, our intervention represents a promising tool for use in health and community settings to benefit large numbers of breast cancer survivors. The current project supports the inclusion of physical activity promotion as an integral component for the management and care of breast cancer survivors.

Objectives: To explore the pain mechanism and the origin of the pain and to evaluate a short-term pain relief treatment in women suffering from CPP persisting after childbirth in order to enable physiotherapeutic intervention. Material and methods: Thirty-six parous women with chronic pelvic pain persisting after childbirth were recruited at the Department of Physiotherapy, SundsvallHospital and by advertisements in newspapers and 29 parous women without chronic pelvic pain were recruited from an organized gynaecological screening at a midwifery surgery. All women were provoked by intra-pelvic palpation of 13 predetermined intra-pelvic landmarks. The provoked pain distribution was expressed in pain drawings and the pain intensity verbally on a Likert scale.Also, in a randomised controlled trial the 36 women with chronic pelvic pain were allocated to bilateral injection treatment with either triamcinolone or saline solutions, given once on the ischial spine with follow-up after four weeks. Results: Referred pain provoked on intra-pelvic landmarks follows a specific pattern. In general, pain provoked by palpation of the posterior intra-pelvic landmarks was mostly referred to the sacral region and pain provoked by palpation of the ischial and pubic bones was mostly referred to the groin and pubic regions. In women with chronic pelvic pain the provoked pain distribution area and pain intensity were magnified as compared to women without chronic pelvic pain. In the clinical trial decreased pain intensity, decreased distribution of pain and improved physical function was achieved among the triamcinolone treatment group as compared to the saline treatment group. Also, a positive correlation was shown between reduced pain intensity and improved function. Conclusions: Referred pain patterns provoked on intra-pelvic landmarks in women with chronic pelvic pain persisting after childbirth are consistent with sclerotomal sensory innervations and indicates allodynia and central sensitisation. This suggests that pain mapping can be used to evaluate and confirm the pain experience and contribute to diagnosis. Also, the pain intensity provoked by stimulation of the intra-pelvic landmarks is suggested to be useful to differentiate women with chronic pelvic pain from those without. Corticosteroid treatment to the ischial spine resulted in decreased pain and increased function.

Background: Currently, participation in the NHS Bowel Cancer Screening Programme (NHSBCSP) is poor, with around half of all people invited returning their (FOBT) kits. The research programme aimed to investigate whether a general practitioner’s (GP) letter encouraging participation and a detailed leaflet explaining how to complete the (FOBT) included with the invitation materials would improve uptake. Methods: The research programme was divided into three phases which were designed to sequentially develop and evaluate the two interventions. The initial and second phases developed and refined the two interventions and the trial outcome measures with previous participants and stakeholder representatives. The final phase was a randomised 2x2 factorial trial conducted with people invited to screening in October 2009. Participants were randomised to either a GP’s endorsement letter and/or a detailed procedural leaflet with their FOBT kit. The primary outcome was verified participation in the NHSBCSP. Questionnaires were also used to evaluate participant perceptions of CRC screening and GPs views on involvement with the NHSBCSP. Results: The factorial trial demonstrated both the GP’s endorsement letter and the detailed procedural leaflet increased participation in the NHSBCSP. In the intention-to-treat analysis, participation improved by 6% for the detailed procedural leaflet and 5.8% for the GP endorsement letter 20 weeks after receipt of the FOBT kit. The random effects logistic regression model confirmed that there was no important interaction between the two interventions, and estimated an adjusted rate ratio of 1.11 (P=0.038) for the GP’s letter and 1.12 (P=0.029) for the leaflet. The per protocol analysis indicated that the insertion of an electronic GP’s signature on the endorsement letter was associated with increased participation (P=0.039). Conclusions: Including both an endorsement letter from each patient’s GP and a detailed procedural leaflet could increase participation in the NHSBCSP by around 10%, a relative improvement of 20% on the current participation rate. Both interventions were well-received by participants and there was minimal impact on GP workload.

Factorial randomised controlled trials (RCTs) evaluate two or more interventions simultaneously, enabling assessment of interactions between treatments. This thesis presents literature reviews, methodological reviews, simulation studies and applied case studies that explore methods for assessing cost-effectiveness based on factorial RCTs. My systematic review suggests that factorial RCTs account for around 3% of trial-based economic evaluations, although there is currently no guidance or methodological work indicating the most appropriate methods. Around 40% of published studies assumed no interaction between treatments and many were poorly-reported. Various mechanisms are likely to produce large interactions within economic endpoints such as costs, quality-adjusted life-years (QALYs) and net benefits. Failing to take account of interactions can introduce bias and prevent efficient allocation of healthcare resources. I developed the opportunity cost of ignoring interactions as a measure of the implications of this bias. However, allowing for small, chance interactions is inefficient, potentially leading to over-investment in research if trial-based evaluations are used to inform decisions about subsequent research. Nonetheless, analyses on simulated trial data suggest that the opportunity cost of adopting a treatment that will not maximise health gains from the healthcare budget is minimised by including all interactions regardless of magnitude or statistical significance. Different approaches for conducting economic evaluations of factorial RCTs (including regression techniques, extrapolation using patient-level simulation, and considering different components of net benefit separately) are evaluated within three applied studies, including both full and partial factorials with 2x2 and 2x2x2 designs. I demonstrate that within both trial-based and model-based economic evaluation, efficient allocation of healthcare resources requires consideration of interactions between treatments, and joint decisions about interacting treatments based on incremental cost-effectiveness evaluated “inside-the-table” on a natural scale. I make recommendations for the design, analysis and reporting of factorial trial-based economic evaluations based on the results of this thesis.

Current treatments for obesity have been unsuccessful. It is essential that a patient-centred approach for obesity management is developed and for this to be successful other diet and lifestyle approaches need to be considered. A systematic review comparing low carbohydrate vs. low fat diets for the treatment of obesity was carried out. It found that low carbohydrate/high protein diets are as effective as, if not better, for treating obesity and cardiovascular disease risk factors. A randomised controlled trial investigating dietary approaches for the treatment of obesity and its co morbidities was carried out. Variables including weight and body composition, cardiovascular risk factors, adipokines, liver and kidney function, and health and lifestyle factors were measured. Those with metabolic syndrome were also examined. It was hypothesised that there are alternative ways of treating obese subjects depending on their phenotype. Those with a higher BMI tend to have a higher carbohydrate intake rather that a higher fat intake so may be better suited to a low carbohydrate/high protein diet rather than the conventional low fat/energy reduced diet. Subjects were initially treated with the standard dietary approach for obesity (health eating, HE) and if not successful after 3 months were randomised to either a very low calorie diet (Lighterlife, LL) or a protein sparing modified fast (PSMF). All three groups showed a significant weight loss and reduced risk for CVD at 12 months. Significant improvements were seen for plasminogen-activated receptor-1, adiponectin, leptin and IL-6 on HE and LL, but only adiponectin significantly improved on the PSMF. Neither diet showed any detrimental effects for those with a healthy liver and kidney function. Quality of life and levels of depression improved at 12 months. Of the 54 subjects with metabolic syndrome at baseline, 12 remained on HE and 32 were randomised to LL and PSMF. This indicates that most subjects did not suit a low fat dietary approach. They were successful at losing weight on LL and PSMF and showed improvement in MS risk factors, and adipokine levels at 12 months. In conclusion, the study demonstrates that a low fat diet may not necessarily be the first line of approach to treat obese subjects with a BMI over 35 kg/m2, including those with MS. A very low calorie diet such as LL or a PSMF may be better suited to the subject.

Producing speech is a highly complex task, involving the integration of sensory and linguistic information, with the precise, high-speed, co-ordination of muscles controlling breathing and the movement of the vocal folds and articulators. In spite of this complexity, producing fluent speech - moving smoothly from one speech sound to the next - can appear effortless. Speech fluency is highly socially valued, and the personal and societal costs of living with a disorder of fluency, such as developmental stuttering, are considerable. The outcomes of behavioural therapies to increase fluency are limited, however, especially for those seeking treatment in adulthood. The overarching aim of this thesis was to investigate how anodal transcranial direct current stimulation (A-TDCS) can be used to increase speech fluency, with a particular focus on the potential application to developmental stuttering. A-TDCS is a noninvasive brain stimulation technique that can enhance the effects of motor, speech, and language training. First, in a series of single-session experiments in typically fluent speakers, I demonstrated that applying A-TDCS over the left IFC increased speech motor learning relative to a sham control, but did not improve consolidation of this learning (chapter 2). Furthermore, I found that neither increasing stimulation intensity from 1 mA to 2 mA, nor changing from a unihemispheric to a bihemispheric configuration, had an additional effect on learning. Next, in single-session study with adults who stutter, I assessed the feasibility of using A-TDCS to improve fluency (chapter 3). Fluency was temporarily induced, by speaking in unison with another person, but the concurrent application of 1-mA unihemispheric A-TDCS over left inferior frontal cortex did not significantly prolong this fluency. Nevertheless, a trend towards stuttering reduction gave some indication that fluency might be increased using a multiple-session approach. Furthermore, I gained a number of important insights from these single-session studies, which I used to inform the design of the final multiple-session trial. In this final study, I completed a randomised controlled trial in 30 adult males with moderate to severe stuttering. Participants were randomized to receive either 1-mA A-TDCS or sham stimulation over left inferior frontal cortex combined with temporary fluency inducing behavioural techniques, for 20 minutes a day over 5 days (chapter 4). A-TDCS significantly reduced disfluency for at least 5 weeks following this intervention. The effect was specific to the speech impairment of development stuttering, as measures of the psycho-social consequences of stuttering were not modulated by A-TDCS. The findings of these studies offer significant promise for the future application of non-invasive stimulation as an adjunctive therapy for adults who stutter. In the concluding chapter, I discuss the important implications of my findings for the future use of this technique.