TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: Study protocol for a cluster randomised controlled trial

Background: Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men presenting with LUTS are managed by their general practitioner (GP) in the first instance, with conservative therapies recommended as the initial treatment. However, the provision of conservative therapies in primary care is variable and can be time and resource limited. GPs require practical resources to enhance patient engagement with such interventions. TRIUMPH aims to determine whether a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for LUTS versus usual care.Methods/design: TRIUMPH is a two-arm, cluster randomised controlled trial (RCT) being conducted in 30 National Health Service (NHS) general practices in England. The TRIUMPH intervention comprises a standardised LUTS advice booklet developed for the trial with patient and healthcare professional (HCP) consultation. The booklet is delivered to patients by nurses/healthcare assistants following assessment of their urinary symptoms. Patients are directed to relevant sections of the booklet, providing the manualised element of the intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. Practices are randomised 1:1 to either deliver the TRIUMPH intervention or a usual care pathway. The patient-reported International Prostate Symptom Score (IPSS) at 12 months post consent is the primary outcome. Secondary outcomes include cost-effectiveness, patient-reported outcomes on LUTS, quality of life, and patient and HCP acceptability and experience of the intervention. Primary analyses will be conducted on an intention-to-treat basis.Discussion: It is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care, therefore, holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic, cluster RCT should provide robust evidence in a primary-care setting to inform future guidelines

Lifestyle modification and metformin as long-term treatment options for obese adolescents: study protocol

<p>Abstract</p> <p>Background</p> <p>Childhood obesity is a serious health concern affecting over 155 million children in developed countries worldwide. Childhood obesity is associated with significantly increased risk for development of type 2 diabetes, cardiovascular disease and psychosocial functioning problems (i.e., depression and decreased quality of life). The two major strategies for management of obesity and associated metabolic abnormalities are lifestyle modification and pharmacologic therapy. This paper will provide the background rationale and methods of the REACH childhood obesity treatment program.</p> <p>Methods/design</p> <p>The REACH study is a 2-year multidisciplinary, family-based, childhood obesity treatment program. Seventy-two obese adolescents (aged 10-16 years) and their parents are being recruited to participate in this randomized placebo controlled trial. Participants are randomized to receive either metformin or placebo, and are then randomized to a moderate or a vigorous intensity supervised exercise program for the first 12-weeks. After the 12-week exercise program, participants engage in weekly exercise sessions with an exercise facilitator at a local community center. Participants engage in treatment sessions with a dietitian and social worker monthly for the first year, and then every three months for the second year. The primary outcome measure is change in body mass index and the secondary outcome measures are changes in body composition, risk factors for type 2 diabetes and cardiovascular disease, changes in diet, physical activity, and psychosocial well-being (e.g., quality of life). It is hypothesized that participants who take metformin and engage in vigorous intensity exercise will show the greatest improvements in body mass index. In addition, it is hypothesized that participants who adhere to the REACH program will show improvements in body composition, physical activity, diet, psychosocial functioning and risk factor profiles for type 2 diabetes and cardiovascular disease. These improvements are expected to be maintained over the 2-year program.</p> <p>Discussion</p> <p>The findings from this study will advance the knowledge regarding the long-term efficacy and sustainability of interventions for childhood obesity.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov number NCT00934570</p

Decision trees for detection of activity intensity in youth with cerebral palsy

PURPOSE - To develop and test decision tree (DT) models to classify physical activity (PA) intensity from accelerometer output and Gross Motor Function Classification System (GMFCS) classification level in ambulatory youth with cerebral palsy (CP); and 2) compare the classification accuracy of the new DT models to that achieved by previously published cut-points for youth with CP. METHODS - Youth with CP (GMFCS Levels I - III) (N=51) completed seven activity trials with increasing PA intensity while wearing a portable metabolic system and ActiGraph GT3X accelerometers. DT models were used to identify vertical axis (VA) and vector magnitude (VM) count thresholds corresponding to sedentary (SED) (/=1.5 and /=3 METs). Models were trained and cross-validated using the 'rpart' and 'caret' packages within R. RESULTS - For the VA (VA_DT) and VM decision trees (VM_DT), a single threshold differentiated LPA from SED, while the threshold for differentiating MVPA from LPA decreased as the level of impairment increased. The average cross-validation accuracy for the VC_DT was 81.1%, 76.7%, and 82.9% for GMFCS levels I, II, and III, respectively. The corresponding cross-validation accuracy for the VM_DT was 80.5%, 75.6%, and 84.2%, respectively. Within each GMFCS level, the decision tree models achieved better PA intensity recognition than previously published cut-points. The accuracy differential was greatest among GMFCS level III participants, in whom the previously published cut-points misclassified 40% of the MVPA activity trials. CONCLUSION - GMFCS-specific cut-points provide more accurate assessments of MVPA levels in youth with CP across the full spectrum of ambulatory ability

Measuring reliability and validity of the ActiGraph GT3X accelerometer for children with cerebral palsy: A feasibility study

PURPOSE The purposes of this study were to: 1) establish inter-instrument reliability between left and right hip accelerometer placement; 2) examine procedural reliability of a walking protocol used to measure physical activity (PA), and; 3) confirm concurrent validity of accelerometers in measuring PA intensity as compared to the gold standard of oxygen consumption measured by indirect calorimetry. METHODS Eight children (mean age: 11.9; SD: 3.2, 75% male) with CP (GMFCS levels I-III) wore ActiGraph GT3X accelerometers on each hip and the Cosmed K4b^{2} portable indirect calorimeter during two measurement sessions in which they performed the six minute walk test (6MWT) at three self-selected speeds (comfortable/slow, brisk, fast). Oxygen consumption (VO2) and accelerometer step and activity count data were recorded. RESULTS Inter-instrument reliability of ActiGraph GT3X accelerometers placed on left and right hips was excellent (ICC=0.96-0.99, CI_{95}: 0.81-0.99). Reproducibility of the protocol was good/excellent (ICC=0.75-0.95, CI_{95}: 0.75-0.98). Concurrent validity of accelerometer count data and VO2 was fair/good (rho=0.67, p< 0.001). The correlation between step count and VO2 was not significant (rho=0.29, p=0.2). CONCLUSION This preliminary research suggests that ActiGraph GT3X accelerometers are reliable and valid devices to monitor PA during walking in children with CP and may be appropriate in rehabilitation research and clinical practice. ActiGraph GTX3 step counts were not valid for this sample and further research is warranted

Socially-Assistive Robots Using Empathy to Reduce Pain and Distress during Peripheral IV Placement in Children

Objectives. Socially-assistive robots (SAR) have been used to reduce pain and distress in children in medical settings. Patients who perceive empathic treatment have increased satisfaction and improved outcomes. We sought to determine if an empathic SAR could be developed and used to decrease pain and fear associated with peripheral IV placement in children. Methods. We conducted a pilot study of children receiving IV placement. Participating children were randomized to interact with (1) no robot, or a commercially available 3D printed humanoid SAR robot programmed with (2) empathy or (3) distraction conditions. Children and parents completed demographic surveys, and children used an adapted validated questionnaire to rate the robot’s empathy on an 8-point Likert scale. Survey scores were compared by the t-test or chi-square test. Pain and fear were measured by self-report using the FACES and FEAR scales, and video tapes were coded using the CHEOPS and FLACC. Scores were compared using repeated measures 2-way ANOVA. This trial is registered with NCT02840942. Results. Thirty-one children with an average age of 9.6 years completed the study. For all measures, mean pain and fear scores were lowest in the empathy group immediately before and after IV placement. Children were more likely to attribute characteristics of empathy to the empathic condition (Likert score 7.24 v. 4.70; p=0.012) and to report that having the empathic vs. distraction robot made the IV hurt less (7.45 vs. 4.88; p=0.026). Conclusions. Children were able to identify SAR designed to display empathic characteristics and reported it helped with IV insertion pain and fear. Mean scores of self-reported or objective pain and fear scales were the lowest in the empathy group and the highest in the distraction condition before and after IV insertion. This result suggests empathy improves SAR functionality when used for painful medical procedures and informs future research into SAR for pain management

Machine learning algorithms for activity recognition in ambulant children and adolescents with cerebral palsy

Abstract Background Cerebral palsy (CP) is the most common physical disability among children (2.5 to 3.6 cases per 1000 live births). Inadequate physical activity (PA) is a major problem effecting the health and well-being of children with CP. Practical, yet accurate measures of PA are needed to evaluate the effectiveness of surgical and therapy-based interventions to increase PA. Accelerometer-based motion sensors have become the standard for objectively measuring PA in children and adolescents; however, current methods for estimating physical activity intensity in children with CP are associated with significant error and may dramatically underestimate HPA in children with more severe mobility limitations. Machine learning (ML) models that first classify the PA type and then predict PA intensity or energy expenditure using activity specific regression equations may be more accurate than standalone regression models. However, the feasibility and validity of ML methods has not been explored in youth with CP. Therefore, the purpose of this study was to develop and test ML models for the automatic identification of PA type in ambulant children with CP. Methods Twenty two children and adolescents (mean age: 12.8 ± 2.9 y) with CP classified at GMFCS Levels I to III completed 7 activity trials while wearing an ActiGraph GT3X+ accelerometer on the hip and wrist. Trials were categorised as sedentary (SED), standing utilitarian movements (SUM), comfortable walking (CW), and brisk walking (BW). Random forest (RF), support vector machine (SVM), and binary decision tree (BDT) classifiers were trained with features extracted from the vector magnitude (VM) of the raw acceleration signal using 10 s non-overlapping windows. Performance was evaluated using leave-one-subject out cross validation. Results SVM (82.0–89.0%) and RF (82.6–88.8%) provided significantly better classification accuracy than BDT (76.1–86.2%). Hip (82.7–85.5%) and wrist (76.1–82.6%) classifiers exhibited comparable prediction accuracy, while the combined hip and wrist (86.2–89.0%) classifiers achieved the best overall performance. For all classifiers, recognition accuracy was excellent for SED (94.1–97.9%), good to excellent for SUM (74.0–96.6%) and brisk walking (71.5–86.0%), and modest for comfortable walking (47.6–70.4%). When comfortable and brisk walking were combined into a single walking class, recognition accuracy ranged from 90.3 to 96.5%. Conclusions ML methods provided acceptable classification accuracy for detection of a range of activities commonly performed by ambulatory children with CP. The resultant models can help clinicians more effectively monitor bouts of brisk walking in the community. The results indicate that 2-step models that first classify PA type and then predict energy expenditure using activity specific regression equations are worthy of exploration in this patient group

Reliability and validity of objective measures of physical activity in youth with cerebral palsy who are ambulatory

BACKGROUND - Physical therapy for youth with cerebral palsy (CP) who are ambulatory includes interventions to increase functional mobility and participation in physical activity (PA). Thus, reliable and valid measures are needed to document PA in youth with CP. OBJECTIVE - The purpose of this study was to evaluate the inter-instrument reliability and concurrent validity of 3 accelerometer-based motion sensors with indirect calorimetry as the criterion for measuring PA intensity in youth with CP. METHODS - Fifty-seven youth with CP (mean age=12.5 years, SD=3.3; 51% female; 49.1% with spastic hemiplegia) participated. Inclusion criteria were: aged 6 to 20 years, ambulatory, Gross Motor Function Classification System (GMFCS) levels I through III, able to follow directions, and able to complete the full PA protocol. Protocol activities included standardized activity trials with increasing PA intensity (resting, writing, household chores, active video games, and walking at 3 self-selected speeds), as measured by weight-relative oxygen uptake (in mL/kg/min). During each trial, participants wore bilateral accelerometers on the upper arms, waist/hip, and ankle and a portable indirect calorimeter. Intraclass coefficient correlations (ICCs) were calculated to evaluate inter-instrument reliability (left-to-right accelerometer placement). Spearman correlations were used to examine concurrent validity between accelerometer output (activity and step counts) and indirect calorimetry. Friedman analyses of variance with post hoc pair-wise analyses were conducted to examine the validity of accelerometers to discriminate PA intensity across activity trials. RESULTS - All accelerometers exhibited excellent inter-instrument reliability (ICC=.94-.99) and good concurrent validity (rho=.70-.85). All accelerometers discriminated PA intensity across most activity trials. LIMITATIONS - This PA protocol consisted of controlled activity trials. CONCLUSIONS - Accelerometers provide valid and reliable measures of PA intensity among youth with CP

Machine learning to quantify physical activity in children with cerebral palsy: Comparison of group, group-personalized, and fully-personalized activity classification models

Pattern recognition methodologies, such as those utilizing machine learning (ML) approaches, have the potential to improve the accuracy and versatility of accelerometer-based assessments of physical activity (PA). Children with cerebral palsy (CP) exhibit significant heterogeneity in relation to impairment and activity limitations; however, studies conducted to date have implemented “one-size fits all” group (G) models. Group-personalized (GP) models specific to the Gross Motor Function Classification (GMFCS) level and fully-personalized (FP) models trained on individual data may provide more accurate assessments of PA; however, these approaches have not been investigated in children with CP. In this study, 38 children classified at GMFCS I to III completed laboratory trials and a simulated free-living protocol while wearing an ActiGraph GT3X+ on the wrist, hip, and ankle. Activities were classified as sedentary, standing utilitarian movements, or walking. In the cross-validation, FP random forest classifiers (99.0–99.3%) exhibited a significantly higher accuracy than G (80.9–94.7%) and GP classifiers (78.7–94.1%), with the largest differential observed in children at GMFCS III. When evaluated under free-living conditions, all model types exhibited significant declines in accuracy, with FP models outperforming G and GP models in GMFCS levels I and II, but not III. Future studies should evaluate the comparative accuracy of personalized models trained on free-living accelerometer data

Serving two masters: Methodism and the negotiation of masculinity in the antebellum South

This dissertation examines the development of a distinct southern Methodist masculinity from the 1830s to the 1860s. More than a church history, this study explores the relationship between non-religious and religious society, the tensions inherent in to relationship, and the ethical questions that emerged from that tension. As Methodism evolved in the South, it took on regional social practices and affectations while also maintaining a denominational identity that opposed southern culture. Southern Methodists served two masters—the church and society—and both demanded obedience to divergent visions of masculinity and manhood. Although they rejected many manly pursuits, ministers adopted a proslavery ideology and patriarchal practices and reflected southern attitudes in their church doctrine and structure. My study argues that the ethical shift that occurred in the southern Methodist Church in the 1840s resulted from the dual demands of southern and denominational culture, which led them to construct their own vision of masculine identity. This study uses the Methodist Church as an example of the friction caused and questions raised by the intersection of gender, religion, and ethics in a constricted, patriarchal society. (Published By University of Alabama Libraries