Review of Evidence for Adult Diabetic Ketoacidosis Management Protocols.

PubMed

Tran, Tara T T; Pease, Anthony; Wood, Anna J; Zajac, Jeffrey D; Mårtensson, Johan; Bellomo, Rinaldo; Ekinci, Elif I I

2017-01-01

Diabetic ketoacidosis (DKA) is an endocrine emergency with associated risk of morbidity and mortality. Despite this, DKA management lacks strong evidence due to the absence of large randomised controlled trials (RCTs). To review existing studies investigating inpatient DKA management in adults, focusing on intravenous (IV) fluids; insulin administration; potassium, bicarbonate, and phosphate replacement; and DKA management protocols and impact of DKA resolution rates on outcomes. Ovid Medline searches were conducted with limits "all adult" and published between "1973 to current" applied. National consensus statements were also reviewed. Eligibility was determined by two reviewers' assessment of title, abstract, and availability. A total of 85 eligible articles published between 1973 and 2016 were reviewed. The salient findings were (i) Crystalloids are favoured over colloids though evidence is lacking. The preferred crystalloid and hydration rates remain contentious. (ii) IV infusion of regular human insulin is preferred over the subcutaneous route or rapid acting insulin analogues. Administering an initial IV insulin bolus before low-dose insulin infusions obviates the need for supplemental insulin. Consensus-statements recommend fixed weight-based over "sliding scale" insulin infusions although evidence is weak. (iii) Potassium replacement is imperative although no trials compare replacement rates. (iv) Bicarbonate replacement offers no benefit in DKA with pH > 6.9. In severe metabolic acidosis with pH < 6.9, there is lack of both data and consensus regarding bicarbonate administration. (v) There is no evidence that phosphate replacement offers outcome benefits. Guidelines consider replacement appropriate in patients with cardiac dysfunction, anaemia, respiratory depression, or phosphate levels <0.32 mmol/L. (vi) Upon resolution of DKA, subcutaneous insulin is recommended with IV insulin infusions ceased with an overlap of 1-2 h. (vii) DKA resolution

Protocol to Isolate a Large Amount of Functional Oligodendrocyte Precursor Cells from the Cerebral Cortex of Adult Mice and Humans

PubMed Central

Medina-Rodríguez, Eva María; Arenzana, Francisco Javier; Bribián, Ana; de Castro, Fernando

2013-01-01

During development, oligodendrocytes are generated from oligodendrocyte precursor cells (OPCs), a cell type that is a significant proportion of the total cells (3-8%) in the adult central nervous system (CNS) of both rodents and humans. Adult OPCs are responsible for the spontaneous remyelination that occurs in demyelinating diseases like Multiple Sclerosis (MS) and they constitute an interesting source of cells for regenerative therapy in such conditions. However, there is little data regarding the neurobiology of adult OPCs isolated from mice since an efficient method to isolate them has yet to be established. We have designed a protocol to obtain viable adult OPCs from the cerebral cortex of different mouse strains and we have compared its efficiency with other well-known methods. In addition, we show that this protocol is also useful to isolate functional OPCs from human brain biopsies. Using this method we can isolate primary cortical OPCs in sufficient quantities so as to be able to study their survival, maturation and function, and to facilitate an evaluation of their utility in myelin repair. PMID:24303061

Protocol to isolate a large amount of functional oligodendrocyte precursor cells from the cerebral cortex of adult mice and humans.

PubMed

Medina-Rodríguez, Eva María; Arenzana, Francisco Javier; Bribián, Ana; de Castro, Fernando

2013-01-01

During development, oligodendrocytes are generated from oligodendrocyte precursor cells (OPCs), a cell type that is a significant proportion of the total cells (3-8%) in the adult central nervous system (CNS) of both rodents and humans. Adult OPCs are responsible for the spontaneous remyelination that occurs in demyelinating diseases like Multiple Sclerosis (MS) and they constitute an interesting source of cells for regenerative therapy in such conditions. However, there is little data regarding the neurobiology of adult OPCs isolated from mice since an efficient method to isolate them has yet to be established. We have designed a protocol to obtain viable adult OPCs from the cerebral cortex of different mouse strains and we have compared its efficiency with other well-known methods. In addition, we show that this protocol is also useful to isolate functional OPCs from human brain biopsies. Using this method we can isolate primary cortical OPCs in sufficient quantities so as to be able to study their survival, maturation and function, and to facilitate an evaluation of their utility in myelin repair.

A Higher-Calorie Refeeding Protocol Does Not Increase Adverse Outcomes in Adult Patients with Eating Disorders.

PubMed

Matthews, Kylie; Hill, Jan; Jeffrey, Shane; Patterson, Susan; Davis, Amanda; Ward, Warren; Palmer, Michelle; Capra, Sandra

2018-04-12

Patients with eating disorders (EDs) are often considered a high-risk population to refeed. Current research advises using "start low, go slow" refeeding methods (∼1,000 kcal/day, advancing ∼500 kcal/day every 3 to 4 days) in adult patients with severe EDs to prevent the development of refeeding syndrome (RFS), typically characterized by decreases in serum electrolyte levels and fluid shifts. To compare the incidence of RFS and related outcomes using a low-calorie protocol (LC) (1,000 kcal) or a higher-calorie protocol (HC) (1,500 kcal) in medically compromised adult patients with EDs. This was a retrospective pre-test-post-test study. One hundred and nineteen participants with EDs, medically admitted to a tertiary hospital in Brisbane, Australia, between December 2010 and January 2017, were included (LC: n=26, HC: n=93). The HC refeeding protocol was implemented in September 2013. Differences in prevalence of electrolyte disturbances, hypoglycemia, edema, and RFS diagnoses were examined. χ 2 tests, Kruskal-Wallis H test, analysis of variance, and independent t tests were used to compare data between the two protocols. Descriptors were similar between groups (LC: 28±9 years, 96% female, 85% with anorexia nervosa, 31% admitted primarily because of clinical symptoms of exacerbated ED vs HC: 27±9 years, 97% female, 84% with anorexia nervosa, 44% admitted primarily because of clinical symptoms of exacerbated ED, P>0.05). Participants refed using the LC protocol had higher incidence rates of hypoglycemia (LC: 31% vs HC: 10%, P=0.012), with no statistical or clinical differences in electrolyte disturbances (LC: 65% vs HC: 45%, P=0.079), edema (LC: 8% vs HC: 6%, P=0.722) or diagnosed RFS (LC: 4% vs HC: 1%, P=0.391). A higher-calorie refeeding protocol appears to be safe, with no differences in rates of electrolyte disturbances or clinically diagnosed RFS and a lower incidence of hypoglycemia. Future research examining higher-calorie intakes, similar to those

Validity of a Protocol for Adult Self-Report of Dyslexia and Related Difficulties

ERIC Educational Resources Information Center

Snowling, Margaret; Dawes, Piers; Nash, Hannah; Hulme, Charles

2012-01-01

Background: There is an increased prevalence of reading and related difficulties in children of dyslexic parents. In order to understand the causes of these difficulties, it is important to quantify the risk factors passed from parents to their offspring. Method: 417 adults completed a protocol comprising a 15-item questionnaire rating reading and…

A feasibility study comparing UK older adult mental health inpatient wards which use protected engagement time with other wards which do not: study protocol.

PubMed

Nolan, Fiona M; Fox, Chris; Cheston, Richard; Turner, David; Clark, Allan; Dodd, Emily; Khoo, Mary-Ellen; Gray, Richard

2016-01-01

Protected engagement time (PET) is a concept of managing staff time on mental health inpatient wards with the aim of increasing staff and patient interaction. Despite apparent widespread use of PET, there remains a dearth of evidence as to how it is implemented and whether it carries benefits for staff or patients. This protocol describes a study which is being carried out on mental health wards caring for older adults (aged over 65) in England. The study shares a large proportion of the procedures, measures and study team membership of a recently completed investigation of the impact of PET in adult acute mental health wards. The study aims to identify prevalence and components of PET to construct a model for the intervention, in addition to testing the feasibility of the measures and procedures in preparation for a randomised trial. The study comprises four modules and uses a mixed methods approach. Module 1 involves mapping all inpatient wards in England which provide care for older adults, including those with dementia, ascertaining how many of these provide PET and in what way. Module 2 uses a prospective cohort method to compare five older adult mental health wards that use PET with five that do not across three National Health Service (NHS) Foundation Trust sites. The comparison comprises questionnaires, observation tools and routinely collected clinical service data and combines validated measures with questions developed specifically for the study. Module 3 entails an in-depth case study evaluation of three of the participating PET wards (one from each NHS Trust site) using semi-structured interviews with patients, carers and staff. Module 4 describes the development of a model and fidelity scale for PET using the information derived from the other modules with a working group of patients, carers and staff. This is a feasibility study to test the application of the measures and methods in inpatient wards for older adults and develop a draft model for the

Factors that impact on the use of mechanical ventilation weaning protocols in critically ill adults and children: a qualitative evidence-synthesis.

PubMed

Jordan, Joanne; Rose, Louise; Dainty, Katie N; Noyes, Jane; Blackwood, Bronagh

2016-10-04

Prolonged mechanical ventilation is associated with a longer intensive care unit (ICU) length of stay and higher mortality. Consequently, methods to improve ventilator weaning processes have been sought. Two recent Cochrane systematic reviews in ICU adult and paediatric populations concluded that protocols can be effective in reducing the duration of mechanical ventilation, but there was significant heterogeneity in study findings. Growing awareness of the benefits of understanding the contextual factors impacting on effectiveness has encouraged the integration of qualitative evidence syntheses with effectiveness reviews, which has delivered important insights into the reasons underpinning (differential) effectiveness of healthcare interventions. 1. To locate, appraise and synthesize qualitative evidence concerning the barriers and facilitators of the use of protocols for weaning critically-ill adults and children from mechanical ventilation;2. To integrate this synthesis with two Cochrane effectiveness reviews of protocolized weaning to help explain observed heterogeneity by identifying contextual factors that impact on the use of protocols for weaning critically-ill adults and children from mechanical ventilation;3. To use the integrated body of evidence to suggest the circumstances in which weaning protocols are most likely to be used. We used a range of search terms identified with the help of the SPICE (Setting, Perspective, Intervention, Comparison, Evaluation) mnemonic. Where available, we used appropriate methodological filters for specific databases. We searched the following databases: Ovid MEDLINE, Embase, OVID, PsycINFO, CINAHL Plus, EBSCOHost, Web of Science Core Collection, ASSIA, IBSS, Sociological Abstracts, ProQuest and LILACS on the 26th February 2015. In addition, we searched: the grey literature; the websites of professional associations for relevant publications; and the reference lists of all publications reviewed. We also contacted authors of

Exploring how nurses assess, monitor and manage acute pain for adult critically ill patients in the emergency department: protocol for a mixed methods study.

PubMed

Varndell, Wayne; Fry, Margaret; Elliott, Doug

2017-08-01

Many critically ill patients experience moderate to severe acute pain that is frequently undetected and/or undertreated. Acute pain in this patient cohort not only derives from their injury and/or illness, but also as a consequence of delivering care whilst stabilising the patient. Emergency nurses are increasingly responsible for the safety and wellbeing of critically ill patients, which includes assessing, monitoring and managing acute pain. How emergency nurses manage acute pain in critically ill adult patients is unknown. The objective of this study is to explore how emergency nurses manage acute pain in critically ill patients in the Emergency Department. In this paper, we provide a detailed description of the methods and protocol for a multiphase sequential mixed methods study, exploring how emergency nurses assess, monitor and manage acute pain in critically ill adult patients. The objective, method, data collection and analysis of each phase are explained. Justification of each method and data integration is described. Synthesis of findings will generate a comprehensive picture of how emergency nurses' perceive and manage acute pain in critically ill adult patients. The results of this study will form a knowledge base to expand theory and inform research and practice.

Hormonal and metabolic responses to a resistance exercise protocol in lean children, obese children and lean adults.

PubMed

Rubin, Daniela A; Castner, Diobel M; Pham, Hoang; Ng, Jason; Adams, Eric; Judelson, Daniel A

2014-11-01

During childhood, varying exercise modalities are recommended to stimulate normal growth, development, and health. This project investigated hormonal and metabolic responses triggered by a resistance exercise protocol in lean children (age: 9.3 ± 1.4 y, body fat: 18.3 ± 4.9%), obese children (age: 9.6 ± 1.3 y, body fat: 40.3 ± 5.2%) and lean adults (age: 23.3 ± 2.4 y, body fat: 12.7 ± 2.9%). The protocol consisted of stepping onto a raised platform (height = 20% of stature) while wearing a weighted vest (resistance = 50% of lean body mass). Participants completed 6 sets of 10 repetitions per leg with a 1-min rest period between sets. Blood samples were obtained at rest preexercise, immediately postexercise and 2 times throughout the 1-hr recovery to analyze possible changes in hormones and metabolites. Children-adult differences included a larger exercise-induced norepinephrine increase in adults vs. children and a decrease in glucagon in children but not adults. Similarities between adults and children were observed for GH-IGF-1 axis responses. Metabolically, children presented with lower glycolytic and increased fat metabolism after exercise than adults did. Obesity in childhood negatively influenced GH, insulin, and glucose concentrations. While adults occasionally differed from children, amount of activated lean mass, not maturation, likely drove these dissimilarities.

A prospective pilot study of home monitoring in adults with cystic fibrosis (HOME-CF): protocol for a randomised controlled trial.

PubMed

Choyce, Jocelyn; Shaw, Karen L; Sitch, Alice J; Mistry, Hema; Whitehouse, Joanna L; Nash, Edward F

2017-01-23

Home monitoring has the potential to detect early pulmonary exacerbations in people with cystic fibrosis (CF), with consequent improvements in health outcomes and healthcare associated costs. This study aims to assess the effects of home monitoring on hospital admissions, quality of life, antibiotic requirements, exacerbation frequency, lung function, nutritional outcomes, anxiety, depression, costs and health outcomes, as well as the qualitative effects on the patient experience. This randomised controlled mixed-methods trial aims to recruit 100 adults with CF cared for in one large regional CF centre. Participants are randomly allocated 1:1 to the intervention group (twice-weekly home monitoring of symptoms measured by the Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) and Forced Expiratory Volume in one second (FEV 1 )) or a control group (routine clinical care) for the 12-month study period. Measurements are recorded at study visits at baseline, 3, 6, 9 and 12 months. Spirometry, body weight, co-morbidities, medications, hospital inpatient days, courses of antibiotics (oral and intravenous), pulmonary exacerbations (defined by the modified Fuchs criteria) are recorded at each study visit. Health status, capability and health economics are measured at each study visit by the Hospital Anxiety and Depression Scale (HADS), the ICEpop CAPability measure for Adults (ICECAP-A), EuroQol 5 dimensions (EQ-5D-5L) questionnaire and an adapted resource use questionnaire. The patient experience is assessed by semi-structured qualitative interviews at baseline and 12 months. Results from this study will help to determine the effect of home monitoring on inpatient bed days and quality of life in adults with CF, as well as other relevant health and health economic outcomes. This study protocol is registered with Clinicaltrials.gov ( NCT02994706 ), date registered 16 th July 2014.

ABO-Incompatible Adult Living Donor Liver Transplantation Under the Desensitization Protocol With Rituximab.

PubMed

Song, G-W; Lee, S-G; Hwang, S; Kim, K-H; Ahn, C-S; Moon, D-B; Ha, T-Y; Jung, D-H; Park, G-C; Kim, W-J; Sin, M-H; Yoon, Y-I; Kang, W-H; Kim, S-H; Tak, E-Y

2016-01-01

ABO incompatibility is no longer considered a contraindication for adult living donor liver transplantation (ALDLT) due to various strategies to overcome the ABO blood group barrier. We report the largest single-center experience of ABO-incompatible (ABOi) ALDLT in 235 adult patients. The desensitization protocol included a single dose of rituximab and total plasma exchange. In addition, local graft infusion therapy, cyclophosphamide, or splenectomy was used for a certain time period, but these treatments were eventually discontinued due to adverse events. There were three cases (1.3%) of in-hospital mortality. The cumulative 3-year graft and patient survival rates were 89.2% and 92.3%, respectively, and were comparable to those of the ABO-compatible group (n = 1301). Despite promising survival outcomes, 17 patients (7.2%) experienced antibody-mediated rejection that manifested as diffuse intrahepatic biliary stricture; six cases required retransplantation, and three patients died. ABOi ALDLT is a feasible method for expanding a living liver donor pool, but the efficacy of the desensitization protocol in targeting B cell immunity should be optimized. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): study protocol for a randomised controlled trial.

PubMed

Ramírez-Vélez, Robinson; Hernandez, Alejandra; Castro, Karem; Tordecilla-Sanders, Alejandra; González-Ruíz, Katherine; Correa-Bautista, Jorge Enrique; Izquierdo, Mikel; García-Hermoso, Antonio

2016-06-24

Although evidence shows the positive health effects of physical activity, most of the adult population in Colombia are sedentary. It is, therefore, important to implement strategies that generate changes in lifestyle behaviours. This protocol describes a study in which we will compare the effects of 12 weeks of high-intensity interval training (HIIT), resistance training (RT) or combined training (HIIT + RT) on the improvement of body composition, endothelial function, blood pressure, blood lipids, and cardiorespiratory fitness in a cohort of sedentary, overweight adults (aged 30-50 years). Sixty sedentary, overweight adults attending primary care in Bogotá, Colombia will be included in a factorial randomised controlled trial. Participants will be randomly assigned to the following intervention groups: (1) non-exercise group: usual care with dietary support, (2) HIIT group: 4 × 4-min intervals at 85-95 % maximum heart rate (HRmax) (with the target zone maintained for at least 2 minutes), interspersed with a 4-min recovery period, at 65 % HRmax, (3) RT group: completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject's weight until an expenditure of 500 kcal at 40-80 % of one-rep max (1RM) has been achieved, and (4) combined group: HIIT + RT. The primary end point for effectiveness is vascular function as measured by flow-mediated vasodilatation 1 week after the end of exercise training. The results of this study will provide new information about the possible effect of the programme in improving the cardiometabolic health of overweight adults, making a more efficient use of an adult's resources over time. ClinicalTrials.gov ID: NCT02715063 . Registered on 8 March 2016.

Health and development of ART conceived young adults: a study protocol for the follow-up of a cohort

PubMed Central

2013-01-01

Background Use of assisted reproductive technologies (ART) continues to increase, yet little is known of the longer term health of ART conceived offspring. There are some adverse birth outcomes associated with ART conception but the subsequent developmental trajectory is unclear. Undertaking research in this area is challenging due the sensitive nature of the topic and the time elapsed since birth of the ART conceived young adults. The aim of this report is to describe a research protocol, including design and ethical considerations, used to compare the physical and psychosocial health outcomes of ART conceived young adults aged 18-28 years, with their spontaneously conceived peers. Design This is a retrospective cohort study of mothers who conceived with ART in Victoria, Australia and gave birth to a singleton child between 1982 and 1992. A current address for each mother was located and a letter of invitation to participate in the study was sent by registered mail. Participation involved completing a telephone interview about her young adult offspring’s health and development from birth to the present. Mothers were also asked for consent for the researcher to contact their son/daughter to invite them to complete a structured telephone interview about their physical and psychosocial health. A comparison group of women living in Victoria, Australia, who had given birth to a spontaneously conceived singleton child between 1982 and 1992 was recruited from the general population using random digit dialling. Data were collected from them and their young adult offspring in the same way. Regression analyses were used to evaluate relationships between ART exposure and health status, including birth defects, chronic health conditions, hospital admissions, growth and sexual development. Psychosocial wellbeing, parental relationships and educational achievement were also assessed. Factors associated with the age of disclosure of ART conception were explored with the ART

Impact of a pharmacist-driven protocol to decrease proton pump inhibitor use in non-intensive care hospitalized adults.

PubMed

Michal, Jessica; Henry, Thomas; Street, Connie

2016-09-01

Results of a pharmacist-driven protocol to decrease proton pump inhibitor (PPI) use in non-intensive care unit (ICU) hospitalized adults are presented. This concurrent preintervention and postintervention study included subjects at least 18 years of age receiving PPIs while hospitalized in general medical or surgical beds. Patients were identified for inclusion in the postintervention group using a daily list of hospitalized patients with active PPI orders. A pharmacist evaluated these subjects for PPI appropriateness, and then recommended discontinuing or changing PPIs to histamine H2-receptor antagonists. Per protocol, the pharmacist could change PPIs to H2-antagonists if prescribers did not respond to recommendations. Preintervention group patients were gathered retrospectively and treated as the retrospective control group. Patients were excluded if they had cumulative ICU or ICU step-down stays of at least two days, had predefined appropriate indications for PPIs, or were not evaluated within one day of PPI orders. The primary outcome was the rate of PPI use. Secondary objectives included rates of prescriber acceptance of pharmacist recommendations and hospital-onset Clostridium difficile infections (HO-CDI). PPIs were discontinued in 66.0% (n = 62) of postintervention group patients compared to 41.1% (n = 39) of the preintervention group (absolute risk reduction, 24.9%; p = 0.001). In the postintervention group, 31.9% (n = 30) of recommendations were accepted, whereas 11.7% (n = 11) were rejected. No subjects in either group were diagnosed with HO-CDI during the study period. The pharmacist-driven protocol described in this study decreased PPI use in non-ICU hospitalized adults. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Publication trends of study protocols in rehabilitation.

PubMed

Jesus, Tiago S; Colquhoun, Heather L

2017-09-04

Growing evidence points for the need to publish study protocols in the health field. To observe whether the growing interest in publishing study protocols in the broader health field has been translated into increased publications of rehabilitation study protocols. Observational study using publication data and its indexation in PubMed. Not applicable. Not applicable. PubMed was searched with appropriate combinations of Medical Subject Headings up to December 2014. The effective presence of study protocols was manually screened. Regression models analyzed the yearly growth of publications. Two-sample Z-tests analyzed whether the proportion of Systematic Reviews (SRs) and Randomized Controlled Trials (RCTs) among study protocols differed from that of the same designs for the broader rehabilitation research. Up to December 2014, 746 publications of rehabilitation study protocols were identified, with an exponential growth since 2005 (r2=0.981; p<0.001). RCT protocols were the most common among rehabilitation study protocols (83%), while RCTs were significantly more prevalent among study protocols than among the broader rehabilitation research (83% vs. 35.8%; p<0.001). For SRs, the picture was reversed: significantly less common among study protocols (2.8% vs. 9.3%; p<0.001). Funding was more often reported by rehabilitation study protocols than the broader rehabilitation research (90% vs. 53.1%; p<0.001). Rehabilitation journals published a significantly lower share of rehabilitation study protocols than they did for the broader rehabilitation research (1.8% vs.16.7%; p<0.001). Identifying the reasons for these discrepancies and reverting unwarranted disparities (e.g. low rate of publication for rehabilitation SR protocols) are likely new avenues for rehabilitation research and its publication. SRs, particularly those aggregating RCT results, are considered the best standard of evidence to guide rehabilitation clinical practice; however, that standard can be improved

The effects of an 8-week computerized cognitive training program in older adults: a study protocol for a randomized controlled trial.

PubMed

Ten Brinke, Lisanne F; Best, John R; Crockett, Rachel A; Liu-Ambrose, Teresa

2018-01-30

Given the world's aging population, it is important to identify strategies that promote healthy cognitive aging and minimize cognitive decline. Currently, no curative pharmaceutical therapy exists for cognitive impairment and dementia. As a result, there is much interest in lifestyle approaches. Specifically, complex mental activity, such as cognitive training, may be a promising method to combat cognitive decline in older adults. As such, the industry of commercial computerized cognitive training (CCT) applications has rapidly grown in the last decade. However, the efficacy of these commercial products is largely not established. Moreover, exercise is a recognized strategy for promoting cognitive outcomes in older adults and may augment the efficacy of computerized cognitive training applications. Therefore, we propose a proof-of-concept randomized controlled trial (RCT) to examine the effect of a commercial CCT program in community-dwelling older adults. An 8-week RCT to examine the effect of a commercial CCT program, alone and preceded by a 15-min brisk walk, on cognitive function and explore the underlying neural mechanisms in adults aged 65-85 years old. Participants will be randomized to one of three intervention groups: 1) Computerized cognitive training (FBT); 2) A 15-min brisk walk followed by computerized cognitive training (Ex-FBT); or 3) A combination of educational classes, sham cognitive training, and balanced and tone exercises (active control, BAT). Participants in all intervention groups will attend three one-hour classes per week over the course of the intervention. Participants will be assessed at baseline, trial completion, and 1-year post study completion (1-year follow-up). If results from this study show benefits for cognition at trial completion, CCT programs, alone or in combination with walking, might be a strategy to promote healthy cognitive aging in older adults. In addition, results from the 1-year follow-up measurement could provide

SU-E-I-32: Benchmarking Head CT Doses: A Pooled Vs. Protocol Specific Analysis of Radiation Doses in Adult Head CT Examinations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fujii, K; UCLA School of Medicine, Los Angeles, CA; Bostani, M

Purpose: The aim of this study was to collect CT dose index data from adult head exams to establish benchmarks based on either: (a) values pooled from all head exams or (b) values for specific protocols. One part of this was to investigate differences in scan frequency and CT dose index data for inpatients versus outpatients. Methods: We collected CT dose index data (CTDIvol) from adult head CT examinations performed at our medical facilities from Jan 1st to Dec 31th, 2014. Four of these scanners were used for inpatients, the other five were used for outpatients. All scanners used Tubemore » Current Modulation. We used X-ray dose management software to mine dose index data and evaluate CTDIvol for 15807 inpatients and 4263 outpatients undergoing Routine Brain, Sinus, Facial/Mandible, Temporal Bone, CTA Brain and CTA Brain-Neck protocols, and combined across all protocols. Results: For inpatients, Routine Brain series represented 84% of total scans performed. For outpatients, Sinus scans represented the largest fraction (36%). The CTDIvol (mean ± SD) across all head protocols was 39 ± 30 mGy (min-max: 3.3–540 mGy). The CTDIvol for Routine Brain was 51 ± 6.2 mGy (min-max: 36–84 mGy). The values for Sinus were 24 ± 3.2 mGy (min-max: 13–44 mGy) and for Facial/Mandible were 22 ± 4.3 mGy (min-max: 14–46 mGy). The mean CTDIvol for inpatients and outpatients was similar across protocols with one exception (CTA Brain-Neck). Conclusion: There is substantial dose variation when results from all protocols are pooled together; this is primarily a function of the differences in technical factors of the protocols themselves. When protocols are analyzed separately, there is much less variability. While analyzing pooled data affords some utility, reviewing protocols segregated by clinical indication provides greater opportunity for optimization and establishing useful benchmarks.« less

Dysphonia risk screening protocol

PubMed Central

Nemr, Katia; Simões-Zenari, Marcia; da Trindade Duarte, João Marcos; Lobrigate, Karen Elena; Bagatini, Flavia Alves

2016-01-01

OBJECTIVE: To propose and test the applicability of a dysphonia risk screening protocol with score calculation in individuals with and without dysphonia. METHOD: This descriptive cross-sectional study included 365 individuals (41 children, 142 adult women, 91 adult men and 91 seniors) divided into a dysphonic group and a non-dysphonic group. The protocol consisted of 18 questions and a score was calculated using a 10-cm visual analog scale. The measured value on the visual analog scale was added to the overall score, along with other partial scores. Speech samples allowed for analysis/assessment of the overall degree of vocal deviation and initial definition of the respective groups and after six months, the separation of the groups was confirmed using an acoustic analysis. RESULTS: The mean total scores were different between the groups in all samples. Values ranged between 37.0 and 57.85 in the dysphonic group and between 12.95 and 19.28 in the non-dysphonic group, with overall means of 46.09 and 15.55, respectively. High sensitivity and specificity were demonstrated when discriminating between the groups with the following cut-off points: 22.50 (children), 29.25 (adult women), 22.75 (adult men), and 27.10 (seniors). CONCLUSION: The protocol demonstrated high sensitivity and specificity in differentiating groups of individuals with and without dysphonia in different sample groups and is thus an effective instrument for use in voice clinics. PMID:27074171

Standardization of a Videofluoroscopic Swallow Study Protocol to Investigate Dysphagia in Dogs.

PubMed

Harris, R A; Grobman, M E; Allen, M J; Schachtel, J; Rawson, N E; Bennett, B; Ledyayev, J; Hopewell, B; Coates, J R; Reinero, C R; Lever, T E

2017-03-01

Videofluoroscopic swallow study (VFSS) is the gold standard for diagnosis of dysphagia in veterinary medicine but lacks standardized protocols that emulate physiologic feeding practices. Age impacts swallow function in humans but has not been evaluated by VFSS in dogs. To develop a protocol with custom kennels designed to allow free-feeding of 3 optimized formulations of contrast media and diets that address limitations of current VFSS protocols. We hypothesized that dogs evaluated by a free-feeding VFSS protocol would show differences in objective swallow metrics based on age. Healthy juvenile, adult, and geriatric dogs (n = 24). Prospective, experimental study. Custom kennels were developed to maintain natural feeding behaviors during VFSS. Three food consistencies (thin liquid, pureed food, and dry kibble) were formulated with either iohexol or barium to maximize palatability and voluntary prehension. Dogs were evaluated by 16 swallow metrics and compared across age groups. Development of a standardized VFSS protocol resulted in successful collection of swallow data in healthy dogs. No significant differences in swallow metrics were observed among age groups. Substantial variability was observed in healthy dogs when evaluated under these physiologic conditions. Features typically attributed to pathologic states, such as gastric reflux, were seen in healthy dogs. Development of a VFSS protocol that reflects natural feeding practices may allow emulation of physiology resulting in clinical signs of dysphagia. Age did not result in significant changes in swallow metrics, but additional studies are needed, particularly in light of substantial normal variation. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial

PubMed Central

Sudore, Rebecca L; Barnes, Deborah E; Le, Gem M; Ramos, Roberto; Osua, Stacy J; Richardson, Sarah A; Boscardin, John; Schillinger, Dean

2016-01-01

Introduction Advance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ACP paradigm to also prepare patients to communicate their wishes and make informed decisions. To this end, we created an ACP website called PREPARE (http://www.prepareforyourcare.org) to prepare diverse English-speaking and Spanish-speaking older adults for medical decision-making. Here, we describe the study protocol for a randomised controlled efficacy trial of PREPARE in a safety-net setting. The goal is to determine the efficacy of PREPARE to engage diverse English-speaking and Spanish-speaking older adults in a full spectrum of ACP behaviours. Methods and analysis We include English-speaking and Spanish-speaking adults from an urban public hospital who are ≥55 years old, have ≥2 chronic medical conditions and have seen a primary care physician ≥2 times in the last year. Participants are randomised to the PREPARE intervention (review PREPARE and an easy-to-read advance directive) or the control arm (only the easy-to-read advance directive). The primary outcome is documentation of an advance directive and/or ACP discussion. Secondary outcomes include ACP behaviour change processes measured with validated surveys (eg, self-efficacy, readiness) and a broad range of ACP actions (eg, choosing a surrogate, identifying goals for care, discussing ACP with clinicians and/or surrogates). Using blinded outcome ascertainment, outcomes will be measured at 1 week and at 3, 6 and 12 months, and compared between study arms using mixed-effects logistic regression and mixed-effects linear, Poisson or negative binomial regression. Ethics and dissemination This study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of this study will

'On Your Feet to Earn Your Seat', a habit-based intervention to reduce sedentary behaviour in older adults: study protocol for a randomized controlled trial.

PubMed

Gardner, Benjamin; Thuné-Boyle, Ingela; Iliffe, Steve; Fox, Kenneth R; Jefferis, Barbara J; Hamer, Mark; Tyler, Nick; Wardle, Jane

2014-09-20

Many older adults are both highly sedentary (that is, spend considerable amounts of time sitting) and physically inactive (that is, do little physical activity). This protocol describes an exploratory trial of a theory-based behaviour change intervention in the form of a booklet outlining simple activities ('tips') designed both to reduce sedentary behaviour and to increase physical activity in older adults. The intervention is based on the 'habit formation' model, which proposes that consistent repetition leads to behaviour becoming automatic, sustaining activity gains over time. The intervention is being developed iteratively, in line with Medical Research Council complex intervention guidelines. Selection of activity tips was informed by semi-structured interviews and focus groups with older adults, and input from a multidisciplinary expert panel. An ongoing preliminary field test of acceptability among 25 older adults will inform further refinement. An exploratory randomized controlled trial will be conducted within a primary care setting, comparing the tips booklet with a control fact sheet. Retired, inactive and sedentary adults (n = 120) aged 60 to 74 years, with no physical impairments precluding light physical activity, will be recruited from general practices in north London, UK. The primary outcomes are recruitment and attrition rates. Secondary outcomes are changes in behaviour, habit, health and wellbeing over 12 weeks. Data will be used to inform study procedures for a future, larger-scale definitive randomized controlled trial. Current Controlled Trials ISRCTN47901994.

The Role of a Conservative Minimal Interventional Management Protocol in the Fractures of the Dentate Portion of the Adult Mandible

PubMed Central

Krishnan, Balasubramanian

2015-01-01

Mandibular fractures are commonly encountered by the maxillofacial surgeon. Maxillomandibular fixation (MMF) and open reduction and internal fixation (ORIF), or a combination of both, are the accepted standard treatments. This study aims to assess the role of a conservative minimal intervention protocol in the management of undisplaced/minimally displaced fractures of the dentate portion of the adult mandible and the complications associated with such minimalistic intervention. Thirty-four patients with undisplaced/minimally displaced fractures of the dentate portion of the adult mandible were advised to restrict mouth opening and limit themselves to a soft diet for a minimum of 4 weeks. All patients were advised follow-up at regular intervals for at least 3 months. Five patients were lost to follow-up. Symphysis and parasymphysis fractures were the most common fracture locations. Fourteen patients needed tension band stabilization with a mandibular arch bar/bridle wiring and three patients required extraction of luxated teeth. All patients showed satisfactory healing except three in whom additional intervention (ORIF) was performed. The improvement in mouth opening was statistically significant. Complications were seen more frequently among smokers and alcoholics. For patients with minimally displaced mandibular fractures, it is necessary to consider if the perceived benefits of intervention justify the associated added costs and possible complications. Patients have to be fully informed about the possible complications while using this minimal intervention protocol. This study concludes that a conservative minimal intervention management protocol for such fractures of the dentate portion of the mandible can produce satisfactory results. PMID:26889344

Testing the efficacy of web-based cognitive behavioural therapy for adult patients with chronic fatigue syndrome (CBIT): study protocol for a randomized controlled trial.

PubMed

Janse, Anthonie; Worm-Smeitink, Margreet; Bussel-Lagarde, José; Bleijenberg, Gijs; Nikolaus, Stephanie; Knoop, Hans

2015-08-12

Cognitive behavioural therapy (CBT) is an effective treatment for fatigue and disabilities in patients with chronic fatigue syndrome (CFS). However, treatment capacity is limited. Providing web-based CBT and tailoring the amount of contact with the therapist to the individual needs of the patient may increase the efficiency of the intervention. Web-based CBT for adolescents with CFS has proven to be effective in reducing fatigue and increasing school attendance. In the proposed study the efficacy of a web-based CBT intervention for adult patients with CFS will be explored. Two different formats of web-based CBT will be tested. In the first format named protocol driven feedback, patients report on their progress and receive feedback from a therapist according to a preset schedule. In the second format named support on demand, feedback and support of the therapist is only given when patients ask for it. The primary objective of the study is to determine the efficacy of a web-based CBT intervention on fatigue severity. A randomized clinical trial will be conducted. Two-hundred-forty adults who have been diagnosed with CFS according to the US Centers for Disease Control and Prevention (CDC) consensus criteria will be recruited and randomized to one of three conditions: web-based CBT with protocol driven feedback, web-based CBT with support on demand, or wait list. Feedback will be delivered by therapists specialized in CBT for CFS. Each of the web-based CBT interventions will be compared to a wait list condition with respect to its effect on the primary outcome measure; fatigue severity. Secondary outcome measures are level of disability, physical functioning, psychological distress, and the proportion of patients with clinical significant improvement in fatigue severity. Outcomes will be assessed at baseline and six months post randomization. The web-based CBT formats will be compared with respect to the time therapists need to deliver the intervention. As far as we

Fluid resuscitation for major burn patients with the TMMU protocol.

PubMed

Luo, Gaoxing; Peng, Yizhi; Yuan, Zhiqiang; Cheng, Wenguang; Wu, Jun; Tang, Jin; Huang, Yuesheng; Fitzgerald, Mark

2009-12-01

Fluid resuscitation is one of the critical treatments for the major burn patient in the early phases after injury. We evaluated the practice of fluid resuscitation for severely burned patients with the Third Military Medical University (TMMU) protocol, which is most widely used in many regions of China. Patients with major burns (>30% total body surface area (TBSA)) presenting to Southwest Hospital, Third Military Medical University, between January 2005 and October 2007, were included in this study. Fluid resuscitation was initiated by the TMMU protocol. A total of 71 patients were (46 adults and 25 children) included in this study. All patients survived the first 48 h after injury smoothly and none developed abdominal compartment syndrome or other recognised complications associated with fluid resuscitation. The average quantity of fluid infused was 3.3-61.33% more than that calculated based on the TMMU protocol in both adult and paediatric groups. The average urine output during the first 24h after injury was about 1.2 ml per kg body weight per hour in the two groups, but reached 1.2 ml and 1.7 ml during the second 24h in adult and pediatric groups, respectively. This study indicates that the TMMU protocol for fluid resuscitation is a feasible option for burn patients. Individualised resuscitation - guided by the physiological response to fluid administration - is still important as in other protocols.

A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial

PubMed Central

Mansfield, Avril; Peters, Amy L; Liu, Barbara A; Maki, Brian E

2007-01-01

Background Previous research investigating exercise as a means of falls prevention in older adults has shown mixed results. Lack of specificity of the intervention may be an important factor contributing to negative results. Change-in-support (CIS) balance reactions, which involve very rapid stepping or grasping movements of the limbs, play a critical role in preventing falls; hence, a training program that improves ability to execute effective CIS reactions could potentially have a profound effect in reducing risk of falling. This paper describes: 1) the development of a perturbation-based balance training program that targets specific previously-reported age-related impairments in CIS reactions, and 2) a study protocol to evaluate the efficacy of this new training program. Methods/Design The training program involves use of unpredictable, multi-directional moving-platform perturbations to evoke stepping and grasping reactions. Perturbation magnitude is gradually increased over the course of the 6-week program, and concurrent cognitive and movement tasks are included during later sessions. The program was developed in accordance with well-established principles of motor learning, such as individualisation, specificity, overload, adaptation-progression and variability. Specific goals are to reduce the frequency of multiple-step responses, reduce the frequency of collisions between the stepping foot and stance leg, and increase the speed of grasping reactions. A randomised control trial will be performed to evaluate the efficacy of the training program. A total of 30 community-dwelling older adults (age 64–80) with a recent history of instability or falling will be assigned to either the perturbation-based training or a control group (flexibility/relaxation training), using a stratified randomisation that controls for gender, age and baseline stepping/grasping performance. CIS reactions will be tested immediately before and after the six weeks of training, using

A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial.

PubMed

Mansfield, Avril; Peters, Amy L; Liu, Barbara A; Maki, Brian E

2007-05-31

Previous research investigating exercise as a means of falls prevention in older adults has shown mixed results. Lack of specificity of the intervention may be an important factor contributing to negative results. Change-in-support (CIS) balance reactions, which involve very rapid stepping or grasping movements of the limbs, play a critical role in preventing falls; hence, a training program that improves ability to execute effective CIS reactions could potentially have a profound effect in reducing risk of falling. This paper describes: 1) the development of a perturbation-based balance training program that targets specific previously-reported age-related impairments in CIS reactions, and 2) a study protocol to evaluate the efficacy of this new training program. The training program involves use of unpredictable, multi-directional moving-platform perturbations to evoke stepping and grasping reactions. Perturbation magnitude is gradually increased over the course of the 6-week program, and concurrent cognitive and movement tasks are included during later sessions. The program was developed in accordance with well-established principles of motor learning, such as individualisation, specificity, overload, adaptation-progression and variability. Specific goals are to reduce the frequency of multiple-step responses, reduce the frequency of collisions between the stepping foot and stance leg, and increase the speed of grasping reactions. A randomised control trial will be performed to evaluate the efficacy of the training program. A total of 30 community-dwelling older adults (age 64-80) with a recent history of instability or falling will be assigned to either the perturbation-based training or a control group (flexibility/relaxation training), using a stratified randomisation that controls for gender, age and baseline stepping/grasping performance. CIS reactions will be tested immediately before and after the six weeks of training, using platform perturbations as

Validation of the Artsana CSI 610 automated blood pressure monitor in adults according to the International Protocol of the European Society of Hypertension.

PubMed

Pini, Claudio; Pastori, Marco; Baccheschi, Jordan; Omboni, Stefano; Parati, Gianfranco

2007-06-01

There is evidence that blood pressure measurement outside the doctor's office can provide valuable information for the diagnostic evaluation of hypertensive patients and for monitoring their response to treatment. Home blood pressure monitoring devices have a major role in this setting, provided that their accuracy in measuring blood pressure is demonstrated by validation studies. This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device Artsana CSI 610 complied with the standard of accuracy indicated by the ESH International Protocol. Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always employed during the study. According to the ESH validation protocol, 99 couples of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants). The Artsana CSI 610 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never <35 within 5 mmHg and never <40 within 10 and 15 mmHg. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -1.4+/-4.8 mmHg for systolic and -0.9+/-3.5 mmHg for diastolic blood pressure. According to the results of the validation study on the basis of the ESH International Protocol, the Artsana CSI 610 can be recommended for clinical use in adults.

A Modified Protocol for High-Quality RNA Extraction from Oleoresin-Producing Adult Pines.

PubMed

de Lima, Júlio César; Füller, Thanise Nogueira; de Costa, Fernanda; Rodrigues-Corrêa, Kelly C S; Fett-Neto, Arthur G

2016-01-01

RNA extraction resulting in good yields and quality is a fundamental step for the analyses of transcriptomes through high-throughput sequencing technologies, microarray, and also northern blots, RT-PCR, and RTqPCR. Even though many specific protocols designed for plants with high content of secondary metabolites have been developed, these are often expensive, time consuming, and not suitable for a wide range of tissues. Here we present a modification of the method previously described using the commercially available Concert™ Plant RNA Reagent (Invitrogen) buffer for field-grown adult pine trees with high oleoresin content.

Benchmarking pediatric cranial CT protocols using a dose tracking software system: a multicenter study.

PubMed

De Bondt, Timo; Mulkens, Tom; Zanca, Federica; Pyfferoen, Lotte; Casselman, Jan W; Parizel, Paul M

2017-02-01

To benchmark regional standard practice for paediatric cranial CT-procedures in terms of radiation dose and acquisition parameters. Paediatric cranial CT-data were retrospectively collected during a 1-year period, in 3 different hospitals of the same country. A dose tracking system was used to automatically gather information. Dose (CTDI and DLP), scan length, amount of retakes and demographic data were stratified by age and clinical indication; appropriate use of child-specific protocols was assessed. In total, 296 paediatric cranial CT-procedures were collected. Although the median dose of each hospital was below national and international diagnostic reference level (DRL) for all age categories, statistically significant (p-value < 0.001) dose differences among hospitals were observed. The hospital with lowest dose levels showed smallest dose variability and used age-stratified protocols for standardizing paediatric head exams. Erroneous selection of adult protocols for children still occurred, mostly in the oldest age-group. Even though all hospitals complied with national and international DRLs, dose tracking and benchmarking showed that further dose optimization and standardization is possible by using age-stratified protocols for paediatric cranial CT. Moreover, having a dose tracking system revealed that adult protocols are still applied for paediatric CT, a practice that must be avoided. • Significant differences were observed in the delivered dose between age-groups and hospitals. • Using age-adapted scanning protocols gives a nearly linear dose increase. • Sharing dose-data can be a trigger for hospitals to reduce dose levels.

Whole-mount Confocal Microscopy for Adult Ear Skin: A Model System to Study Neuro-vascular Branching Morphogenesis and Immune Cell Distribution.

PubMed

Yamazaki, Tomoko; Li, Wenling; Mukouyama, Yoh-Suke

2018-03-29

Here, we present a protocol of a whole-mount adult ear skin imaging technique to study comprehensive three-dimensional neuro-vascular branching morphogenesis and patterning, as well as immune cell distribution at a cellular level. The analysis of peripheral nerve and blood vessel anatomical structures in adult tissues provides some insights into the understanding of functional neuro-vascular wiring and neuro-vascular degeneration in pathological conditions such as wound healing. As a highly informative model system, we have focused our studies on adult ear skin, which is readily accessible for dissection. Our simple and reproducible protocol provides an accurate depiction of the cellular components in the entire skin, such as peripheral nerves (sensory axons, sympathetic axons, and Schwann cells), blood vessels (endothelial cells and vascular smooth muscle cells), and inflammatory cells. We believe this protocol will pave the way to investigate morphological abnormalities in peripheral nerves and blood vessels as well as the inflammation in the adult ear skin under different pathological conditions.

The NAtional randomised controlled Trial of Tonsillectomy IN Adults (NATTINA): a clinical and cost-effectiveness study: study protocol for a randomised control trial.

PubMed

Rubie, Isabel; Haighton, Catherine; O'Hara, James; Rousseau, Nikki; Steen, Nick; Stocken, Deborah D; Sullivan, Frank; Vale, Luke; Wilkes, Scott; Wilson, Janet

2015-06-06

The role of tonsillectomy in the management of adult tonsillitis remains uncertain and UK regional variation in tonsillectomy rates persists. Patients, doctors and health policy makers wish to know the costs and benefits of tonsillectomy against conservative management and whether therapy can be better targeted to maximise benefits and minimise risks of surgery, hence maximising cost-effective use of resources. NATTINA incorporates the first attempt to map current NHS referral criteria against other metrics of tonsil disease severity. A UK multi-centre, randomised, controlled trial for adults with recurrent tonsillitis to compare the clinical and cost-effectiveness of tonsillectomy versus conservative management. An initial feasibility study comprises qualitative interviews to investigate the practicality of the protocol, including willingness to randomise and be randomised. Approximately 20 otolaryngology staff, 10 GPs and 15 ENT patients will be recruited over 5 months in all 9 proposed main trial participating sites. A 6-month internal pilot will then recruit 72 patients across 6 of the 9 sites. Participants will be adults with recurrent acute tonsillitis referred by a GP to secondary care. Randomisation between tonsillectomy and conservative management will be according to a blocked allocation method in a 1:1 ratio stratified by centre and baseline disease severity. If the pilot is successful, the main trial will recruit a further 528 patients over 18 months in all 9 participating sites. All participants will be followed up for a total of 24 months, throughout which both primary and secondary outcome data will be collected. The primary outcome is the number of sore throat days experienced over the 24-month follow-up. The pilot and main trials include an embedded qualitative process evaluation. NATTINA is designed to evaluate the relative effectiveness and efficiency of tonsillectomy versus conservative management in patients with recurrent sore throat who are

Scapular positioning and motor control in children and adults: a laboratory study using clinical measures.

PubMed

Struyf, Filip; Nijs, Jo; Horsten, Stijn; Mottram, Sarah; Truijen, Steven; Meeusen, Romain

2011-04-01

The scapular muscular system is the major determinant of scapular positioning. In addition, strength and muscular endurance develops from childhood through adolescence. It is not known whether differences in scapular positioning and motor control between adults and children may exist. Ninety-two shoulders of 46 adults (mean = 39.4; 18-86 years; SD = 22.5), and 116 shoulders of 59 children (mean = 11.6; 6-17 years; SD = 3.5), were included in the study. Scapular positioning data were collected using a clinical assessment protocol including visual observation of titling and winging, measurement of forward shoulder posture, measurement of scapular upward rotation, and the Kinetic Medial Rotation Test (KMRT). The observation protocol for scapular winging and tilting did not show significant differences between adults and children. After controlling for height, forward shoulder posture (relaxed (0.28 cm/cm (0.06) vs. 0.31 cm/cm (0.07) and retracted (0.15 cm/cm (0.05) vs. 0.20 cm/cm (0.06)) were significantly smaller in children than in adults (P < 0.01). In addition, children showed greater scapular upward rotation (18.6°; SD 9.6°) than adults (14.5°; SD 10.9°) at 90° shoulder abduction. No significant differences were seen between children (19% positive test) and adults (24% positive test) using the KMRT. Children and adults show significant but small differences in scapular upward rotation and forward shoulder posture. These data provide useful reference values using a clinical protocol. Copyright © 2010 Elsevier Ltd. All rights reserved.

Telehealth methods to deliver multifactorial dietary interventions in adults with chronic disease: a systematic review protocol.

PubMed

Kelly, Jaimon T; Reidlinger, Dianne P; Hoffmann, Tammy C; Campbell, Katrina L

2015-12-22

The long-term management of chronic diseases requires adoption of complex dietary recommendations, which can be facilitated by regular coaching to support sustained behaviour change. Telehealth interventions can overcome patient-centred barriers to accessing face-to-face programs and provide feasible delivery methods, ubiquitous and accessible regardless of geographic location. The protocol for this systematic review explains the methods that will be utilised to answer the review question of whether telehealth interventions are effective at promoting change in dietary intake and improving diet quality in people with chronic disease. A structured search of Medline, EMBASE, CINAHL, and PsychINFO, from their inception, will be conducted. We will consider randomised controlled trials which evaluate complex dietary interventions in adults with chronic disease. Studies must provide diet education in an intervention longer than 4 weeks in duration, and at least half of the intervention contact must be delivered via telehealth. Comparisons will be made against usual care or a non-telehealth intervention. The primary outcome of interest is dietary change with secondary outcomes relating to clinical markers pre-specified in the methodology. The process for selecting studies, extracting data, and resolving conflicts will follow a set protocol. Two authors will independently appraise the studies and extract the data, using specified methods. Meta-analyses will be conducted where appropriate, with parameters for determining statistical heterogeneity pre-specified. The GRADE tool will be used for determining the quality of evidence for analysed outcomes. To date, there has been a considerable variability in the strategies used to deliver dietary education, and the overall effectiveness of telehealth dietary interventions for facilitating dietary change has not been reviewed systematically in adults with chronic disease. A systematic synthesis of telehealth strategies will inform

Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial.

PubMed

Sudore, Rebecca L; Barnes, Deborah E; Le, Gem M; Ramos, Roberto; Osua, Stacy J; Richardson, Sarah A; Boscardin, John; Schillinger, Dean

2016-07-11

Advance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ACP paradigm to also prepare patients to communicate their wishes and make informed decisions. To this end, we created an ACP website called PREPARE (http://www.prepareforyourcare.org) to prepare diverse English-speaking and Spanish-speaking older adults for medical decision-making. Here, we describe the study protocol for a randomised controlled efficacy trial of PREPARE in a safety-net setting. The goal is to determine the efficacy of PREPARE to engage diverse English-speaking and Spanish-speaking older adults in a full spectrum of ACP behaviours. We include English-speaking and Spanish-speaking adults from an urban public hospital who are ≥55 years old, have ≥2 chronic medical conditions and have seen a primary care physician ≥2 times in the last year. Participants are randomised to the PREPARE intervention (review PREPARE and an easy-to-read advance directive) or the control arm (only the easy-to-read advance directive). The primary outcome is documentation of an advance directive and/or ACP discussion. Secondary outcomes include ACP behaviour change processes measured with validated surveys (eg, self-efficacy, readiness) and a broad range of ACP actions (eg, choosing a surrogate, identifying goals for care, discussing ACP with clinicians and/or surrogates). Using blinded outcome ascertainment, outcomes will be measured at 1 week and at 3, 6 and 12 months, and compared between study arms using mixed-effects logistic regression and mixed-effects linear, Poisson or negative binomial regression. This study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of this study will be disseminated to academic and community stakeholders

Patient-based estimation of organ dose for a population of 58 adult patients across 13 protocol categories

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sahbaee, Pooyan, E-mail: psahbae@ncsu.edu; Segars, W. Paul; Samei, Ehsan

2014-07-15

Purpose: This study aimed to provide a comprehensive patient-specific organ dose estimation across a multiplicity of computed tomography (CT) examination protocols. Methods: A validated Monte Carlo program was employed to model a common CT system (LightSpeed VCT, GE Healthcare). The organ and effective doses were estimated from 13 commonly used body and neurological CT examination. The dose estimation was performed on 58 adult computational extended cardiac-torso phantoms (35 male, 23 female, mean age 51.5 years, mean weight 80.2 kg). The organ dose normalized by CTDI{sub vol} (h factor) and effective dose normalized by the dose length product (DLP) (k factor)more » were calculated from the results. A mathematical model was derived for the correlation between the h and k factors with the patient size across the protocols. Based on this mathematical model, a dose estimation iPhone operating system application was designed and developed to be used as a tool to estimate dose to the patients for a variety of routinely used CT examinations. Results: The organ dose results across all the protocols showed an exponential decrease with patient body size. The correlation was generally strong for the organs which were fully or partially located inside the scan coverage (Pearson sample correlation coefficient (r) of 0.49). The correlation was weaker for organs outside the scan coverage for which distance between the organ and the irradiation area was a stronger predictor of dose to the organ. For body protocols, the effective dose before and after normalization by DLP decreased exponentially with increasing patient's body diameter (r > 0.85). The exponential relationship between effective dose and patient's body diameter was significantly weaker for neurological protocols (r < 0.41), where the trunk length was a slightly stronger predictor of effective dose (0.15 < r < 0.46). Conclusions: While the most accurate estimation of a patient dose requires specific modeling of the

Optimizing the high-resolution manometry (HRM) study protocol.

PubMed

Patel, A; Ding, A; Mirza, F; Gyawali, C P

2015-02-01

Intolerance of the esophageal manometry catheter may prolong high-resolution manometry (HRM) studies and increase patient distress. We assessed the impact of obtaining the landmark phase at the end of the study when the patient has acclimatized to the HRM catheter. 366 patients (mean age 55.4 ± 0.8 years, 62.0% female) undergoing esophageal HRM over a 1-year period were studied. The standard protocol consisted of the landmark phase, 10 5 mL water swallows 20-30 s apart, and multiple rapid swallows where 4-6 2 mL swallows were administered in rapid succession. The modified protocol consisted of the landmark phase at the end of the study after test swallows. Study duration, technical characteristics, indications, and motor findings were compared between standard and modified protocols. Of the 366 patients, 89.6% underwent the standard protocol (study duration 12.9 ± 0.3 min). In 10.4% with poor catheter tolerance undergoing the modified protocol, study duration was significantly longer (15.6 ± 1.0 min, p = 0.004) despite similar duration of study maneuvers. Only elevated upper esophageal sphincter basal pressures at the beginning of the study segregated modified protocol patients. The 95th percentile time to landmark phase in the standard protocol patients was 6.1 min; as many as 31.4% of modified protocol patients could not obtain their first study maneuver within this period (p = 0.0003). Interpretation was not impacted by shifting the landmark phase to the end of the study. Modification of the HRM study protocol with the landmark phase obtained at the end of the study optimizes study duration without compromising quality. © 2014 John Wiley & Sons Ltd.

Validity of a Protocol for Adult Self-Report of Dyslexia and Related Difficulties

PubMed Central

Snowling, Margaret; Dawes, Piers; Nash, Hannah; Hulme, Charles

2012-01-01

Background There is an increased prevalence of reading and related difficulties in children of dyslexic parents. In order to understand the causes of these difficulties, it is important to quantify the risk factors passed from parents to their offspring. Method 417 adults completed a protocol comprising a 15-item questionnaire rating reading and related skills and a scale assessing ADHD symptoms; 344 completed reading, nonword reading and spelling tests. Results A confirmatory factor analysis with four factors (Reading, Word Finding, Attention and Hyperactivity) provided a reasonable fit to the data. The Reading Factor showed robust correlations with measured literacy skills. Adults who reported as dyslexic, or rated their reading difficulties as more severe, gained lower scores on objective measures of literacy skills. Although the sensitivity of the new scale was acceptable, it tended to miss some cases of low literacy. Conclusions Self-report scales of reading and of attention difficulties are useful for identifying adults with reading and attention difficulties which may confer risks on their children of related problems. It is important for research following children at family risk of dyslexia to be aware of these effects. Copyright © 2012 John Wiley & Sons, Ltd. PMID:22271419

Validity of a protocol for adult self-report of dyslexia and related difficulties.

PubMed

Snowling, Margaret; Dawes, Piers; Nash, Hannah; Hulme, Charles

2012-02-01

There is an increased prevalence of reading and related difficulties in children of dyslexic parents. In order to understand the causes of these difficulties, it is important to quantify the risk factors passed from parents to their offspring. 417 adults completed a protocol comprising a 15-item questionnaire rating reading and related skills and a scale assessing ADHD symptoms; 344 completed reading, nonword reading and spelling tests. A confirmatory factor analysis with four factors (Reading, Word Finding, Attention and Hyperactivity) provided a reasonable fit to the data. The Reading Factor showed robust correlations with measured literacy skills. Adults who reported as dyslexic, or rated their reading difficulties as more severe, gained lower scores on objective measures of literacy skills. Although the sensitivity of the new scale was acceptable, it tended to miss some cases of low literacy. Self-report scales of reading and of attention difficulties are useful for identifying adults with reading and attention difficulties which may confer risks on their children of related problems. It is important for research following children at family risk of dyslexia to be aware of these effects. Copyright © 2011 John Wiley & Sons, Ltd.

Metastatic medulloblastoma in adults: outcome of patients treated according to the HIT2000 protocol.

PubMed

von Bueren, André O; Friedrich, Carsten; von Hoff, Katja; Kwiecien, Robert; Müller, Klaus; Pietsch, Torsten; Warmuth-Metz, Monika; Hau, Peter; Benesch, Martin; Kuehl, Joachim; Kortmann, Rolf D; Rutkowski, Stefan

2015-11-01

Due to the rarity of metastatic medulloblastoma in adults, knowledge about the efficacy and toxicity of intensified chemotherapy and radiotherapy is limited. Adults with disseminated medulloblastoma registered in the HIT2000 trial as observational patients and treated according to one of two different treatment regimens were analysed. The sandwich strategy MET-HIT2000AB4 consists of postoperative chemotherapy, hyperfractionated craniospinal radiotherapy, and maintenance chemotherapy; while the HIT'91 maintenance strategy consists of postoperative craniospinal radiotherapy, and maintenance chemotherapy. Twenty-three patients (median age: 30.7years), diagnosed from November 2001 to July 2009, and treated in 18 institutions in Germany and Austria, were eligible. The median follow-up of surviving patients was 3.99years. The 4-year event-free survival (EFS) and overall survival (OS)±standard error (SE) were 52%±12% and 91%±6%, respectively. The survival was similar in both treatment groups (HIT'91 maintenance strategy, n=9; MET-HIT2000AB4 sandwich strategy, n=14). Patients with large cell/anaplastic medulloblastoma relapsed and died (n=2; 4-year EFS/OS: 0%) and OS differed compared to patients with classic (n=11; 4-year EFS/OS: 71%/91%) and desmoplastic medulloblastoma (n=10; 4-year EFS/OS: 48%/100%), respectively (p=0.161 for EFS and p=0.033 for OS). Treatment-induced toxicities consisted mainly of neurotoxicity (50% of patients, ⩾ °II), followed by haematotoxicity and nephrotoxicity/ototoxicity. The professional outcome appeared to be negatively affected in the majority of evaluable patients (9/10). Treatment of adults with metastatic medulloblastoma according to the intensified paediatric HIT2000 protocol was feasible with acceptable toxicities. EFS rates achieved by both chemotherapeutic protocols were favourable and appear to be inferior to those obtained in older children/adolescents with metastatic disease. Copyright © 2015 Elsevier Ltd. All rights

Wayfinding in ageing and Alzheimer's disease within a virtual senior residence: study protocol.

PubMed

Davis, Rebecca; Ohman, Jennifer

2016-07-01

To report a study protocol that examines the impact of adding salient cues in a virtual reality simulation of a senior residential building on wayfinding for older adults with and without Alzheimer's disease. An early symptom of Alzheimer's disease is the inability to find one's way (wayfinding). Senior residential environments are especially difficult for wayfinding. Salient cues may be able to help persons with Alzheimer's disease find their way more effectively so they can maintain independence. A repeated measures, within and between subjects design. This study was funded by the National Institutes of Health (August 2012). Older adults (N = 40) with normal cognition and older adults with early stage Alzheimer's disease/mild cognitive impairment (N = 40) will try to find their way to a location repeatedly in a virtual reality simulation of senior residence. There are two environments: standard (no cues) and salient (multiple cues). Outcome measures include how often and how quickly participants find the target location in each cue condition. The results of this study have the potential to provide evidence for ways to make the environment more supportive for wayfinding for older adults with Alzheimer's disease. This study is registered at Trialmatch.alz.org (Identifier 260425-5). © 2016 John Wiley & Sons Ltd.

The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial.

PubMed

Murphy, Jill; Goldsmith, Charles H; Jones, Wayne; Oanh, Pham Thi; Nguyen, Vu Cong

2017-05-05

Depressive disorders are one of the leading causes of disease and disability worldwide. In Vietnam, although epidemiological evidence suggests that depression rates are on par with global averages, services for depression are very limited. In a feasibility study that was implemented from 2013 to 2015, we found that a Supported Self-management (SSM) intervention showed promising results for adults with depression in the community in Vietnam. This paper describes the Mental Health in Adults and Children: Frugal Innovations (MAC-FI) trial protocol that will assess the effectiveness of the SSM intervention, delivered by primary care and social workers, to community-based populations of adults with depression in eight Vietnamese provinces. The MAC-FI program will be assessed using a stepped-wedge, randomized controlled trial. Study participants are adults aged 18 years and over in eight provinces of Vietnam. Study participants will be screened at primary care centres and in the community by health and social workers using the Self-reporting Questionnaire-20 (SRQ-20). Patients scoring >7, indicating depression caseness, will be invited to participate in the study in either the SSM intervention group or the enhanced treatment as usual control group. Recruited participants will be further assessed using the World Health Organization's Disability Assessment Scale (WHODAS 2.0) and the Cut-down, Annoyed, Guilty, Eye-opener (CAGE) Questionnaire for alcohol misuse. Intervention-group participants will receive the SSM intervention, delivered with the support of a social worker or social collaborator, for a period of 2 months. Control- group participants will receive treatment as usual and a leaflet with information about depression. SRQ-20, WHODAS 2.0 and CAGE scores will be taken by blinded outcome assessors at baseline, after 1 month and after 2 months. The primary analysis method will be intention-to-treat. This study has the potential to add to the knowledge base about

Screening protocol for dysphagia in adults: comparison with videofluoroscopic findings.

PubMed

Sassi, Fernanda C; Medeiros, Gisele C; Zilberstein, Bruno; Jayanthi, Shri Krishna; de Andrade, Claudia R F

2017-12-01

To compare the videofluoroscopic findings of patients with suspected oropharyngeal dysphagia with the results of a clinical screening protocol. A retrospective observational cohort study was conducted on all consecutive patients with suspected oropharyngeal dysphagia between March 2015 and February 2016 who were assigned to receive a videofluoroscopic assessment of swallowing. All patients were first submitted to videofluoroscopy and then to the clinical assessment of swallowing. The clinical assessment was performed within the first 24 hours after videofluoroscopy. The videofluoroscopy results were analyzed regarding penetration/aspiration using an 8-point multidimensional perceptual scale. The accuracy of the clinical protocol was analyzed using the sensitivity, specificity, likelihood ratios and predictive values. The selected sample consisted of 50 patients. The clinical protocol presented a sensitivity of 50% and specificity of 95%, with an accuracy of 88%. "Cough" and "wet-hoarse" vocal quality after/during swallowing were clinical indicators that appeared to correctly identify the presence of penetration/aspiration risk. The clinical protocol used in the present study is a simple, rapid and reliable clinical assessment. Despite the absence of a completely satisfactory result, especially in terms of the sensitivity and positive predictive values, we suggest that lower rates of pneumonia can be achieved using a formal dysphagia screening method.

Community-based physical activity and nutrition programme for adults with metabolic syndrome in Vietnam: study protocol for a cluster-randomised controlled trial

PubMed Central

Tran, Van Dinh; Lee, Andy H; Jancey, Jonine; James, Anthony P; Howat, Peter; Thi Phuong Mai, Le

2016-01-01

Introduction Metabolic syndrome (MetS) is a cluster of risk factors for cardiovascular diseases and type II diabetes. In Vietnam, more than one-quarter of its population aged 50–65 have MetS. This cluster-randomised controlled trial aims to evaluate the effectiveness of interventions to increase levels of physical activity and improve dietary behaviours among Vietnamese adults aged 50–65 years with MetS. Method and analysis This 6-month community-based intervention includes a range of strategies to improve physical activity and nutrition for adults with MetS in Hanam, a province located in northern Vietnam. 600 participants will be recruited from 6 communes with 100 participants per commune. The 6 selected communes will be randomly allocated to either an intervention group (m=3; n=300) or a control group (m=3; n=300). The intervention comprises booklets, education sessions, resistance bands and attending local walking groups that provide information and encourage participants to improve their physical activity and healthy eating behaviours during the 6-month period. The control group participants will receive standard and 1-time advice. Social cognitive theory is the theoretical concept underpinning this study. Measurements will be taken at baseline and postintervention to evaluate programme effectiveness. Ethics and dissemination The research protocol was approved by the Curtin University Human Research Ethics Committee (approval number: HR139/2014). The results of the study will be disseminated through publications, reports and conference presentations. Trial registration number ACTRN12614000811606. PMID:27256094

Effectiveness of neurofeedback therapy for anxiety and stress in adults living with a chronic illness: a systematic review protocol.

PubMed

Blaskovits, Farriss; Tyerman, Jane; Luctkar-Flude, Marian

2017-07-01

The objective of this review is to systematically examine the effectiveness of neurofeedback therapy for managing anxiety and stress in adults living with a chronic illness.The specific objectives are to identify which neurofeedback systems and/or protocols demonstrate effectiveness and determine the level of supporting evidence.The review question is as follows: What is the effectiveness of neurofeedback therapy for managing anxiety and stress in an adult population aged 18 years of age or older living with a chronic illness?

The characteristics of national health initiatives promoting earlier cancer diagnosis among adult populations: a systematic review protocol

PubMed Central

Calanzani, Natalia; Weller, David; Campbell, Christine

2017-01-01

Introduction The increasing burden of cancer morbidity and mortality has led to the development of national health initiatives to promote earlier cancer diagnosis and improve cancer survival. This protocol describes a systematic review aiming to identify the evidence about such initiatives among the adult population. We will describe their components, stakeholders and target populations, and summarise their outcomes. Methods and analysis We will search databases and websites for peer-reviewed publications and grey literature on national health initiatives in high-income countries as defined by the World Bank. Quantitative, qualitative and mixed-methods studies will be included and assessed for their methodological quality. Study selection, quality assessment and data extraction will be carried out independently by two reviewers. Narrative synthesis will be used to analyse the findings. Ethics and dissemination This systematic review analyses secondary data and ethical approval is not required. Review findings will be helpful to researchers, policy makers, governments and other key stakeholders developing similar initiatives and assessing cancer outcomes. The results will be submitted to a peer-reviewed journal in order to reach a diverse group of healthcare professionals, researchers and policy makers. This systematic review protocol is registered at PROSPERO (CRD42016047233). PMID:28698336

SU-F-I-46: Optimizing Dose Reduction in Adult Head CT Protocols While Maintaining Image Quality in Postmortem Head Scans

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lipnharski, I; Carranza, C; Quails, N

Purpose: To optimize adult head CT protocol by reducing dose to an appropriate level while providing CT images of diagnostic quality. Methods: Five cadavers were scanned from the skull base to the vertex using a routine adult head CT protocol (120 kVp, 270 mA, 0.75 s rotation, 0.5 mm × 32 detectors, 70.8 mGy CTDIvol) followed by seven reduced-dose protocols with varying combinations of reduced tube current, reduced rotation time, and increased detectors with CTDIvol ranging from 38.2 to 65.6 mGy. Organ doses were directly measured with 21 OSL dosimeters placed on the surface and implanted in the head bymore » a neurosurgeon. Two neuroradiologists assessed grey-white matter differentiation, fluid space, ventricular size, midline shift, brain mass, edema, ischemia, and skull fractures on a three point scale: (1) Unacceptable, (2) Borderline Acceptable, and (3) Acceptable. Results: For the standard scan, doses to the skin, lens of the eye, salivary glands, thyroid, and brain were 37.55 mGy, 49.65 mGy, 40.67 mGy, 4.63 mGy, and 27.33 mGy, respectively. Two cadavers had cerebral edema due to changing dynamics of postmortem effects, causing the grey-white matter differentiation to appear less distinct. Two cadavers with preserved grey-white matter received acceptable scores for all image quality features for the protocol with a CTDIvol of 57.3 mGy, allowing organ dose savings ranging from 34% to 45%. One cadaver allowed for greater dose reduction for the protocol with a CTDIvol of 42 mGy. Conclusion: Efforts to optimize scan protocol should consider both dose and clinical image quality. This is made possible with postmortem subjects, whose brains are similar to patients, allowing for an investigation of ideal scan parameters. Radiologists at our institution accepted scan protocols acquired with lower scan parameters, with CTDIvol values closer to the American College of Radiology’s (ACR) Achievable Dose level of 57 mGy.« less

Regional fat distribution in adolescent and adult females with anorexia nervosa: A longitudinal study.

PubMed

El Ghoch, Marwan; Milanese, Chiara; Calugi, Simona; Müller, Manfred J; Pourhassan, Maryam; Ruocco, Antonella; Dalle Grave, Riccardo

2015-12-01

No study has yet compared body fat distribution before and after weight restoration in adolescent and adult patients with anorexia nervosa (AN) treated according to the same protocol. The study was set up to measure body fat distribution before and after short-term weight restoration in adolescent and adult patients with AN treated according to the same protocol in a specialist inpatient unit. We recruited 33 consecutive adolescent female patients with AN, and 33 controls matched by age and post-treatment BMI centile, as well as 33 adult female patients with AN, and 33 controls matched by age and post-treatment BMI. Dual-energy X-ray absorptiometry (DXA) was used to assess body composition before and after short-term weight restoration (BMI ≥ 18.5 kg/m²). Compared with controls, both adolescents and adults with AN showed that a greater amount of fat was lost from the extremities than the trunk before weight restoration, and that there was a central adiposity phenotype after short-term weight restoration. There were no significant differences in body fat distribution between adolescents and adults with AN before or after short-term weight restoration. Adolescent and adult females with AN have similar body fat distribution both before and after short-term weight restoration, and show a central adiposity phenotype after short-term weight restoration. The clinical implications of this finding are as yet unknown. Clinical Trials Registry- Regional Fat Distribution in Adolescent Girls and Adults with Anorexia Nervosa (ISRCTN73572502). Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

A Telerehabilitation Approach to Enhance Quality of Life Through Exercise Among Adults With Paraplegia: Study Protocol.

PubMed

Sweet, Shane Norman; Rocchi, Meredith; Arbour-Nicitopoulos, Kelly; Kairy, Dahlia; Fillion, Brigitte

2017-10-19

assessment, participants will be randomly assigned to the intervention or control group. Participants in the intervention group will participate in 8 weekly, 1-hour video-based telerehabilitation sessions with a trained physical activity counselor, while participants in the control group will be asked to continue with their regular routine. We expect higher ratings of the basic psychological needs and autonomous motivation and lower scores for controlled motivation for the intervention group compared to the control group (Objective 1). We also expect that our video-based intervention will have moderate effects on exercise participation, as well as small-to-moderate positive effects on the quality of life‒related variables (Objective 2). Finally, we expect the intervention to have a small positive effect on psychosocial predictors of physical activity and well-being (Objective 3). We anticipate that the results will show that the intervention is appropriate for adults with paraplegia and feasible to test in a full-scale RCT. ClinicalTrials.gov NCT02833935; https://clinicaltrials.gov/ct2/show/NCT02833935 (Archived by WebCite at http://www.webcitation.org/6u8U9x2yt). ©Shane Norman Sweet, Meredith Rocchi, Kelly Arbour-Nicitopoulos, Dahlia Kairy, Brigitte Fillion. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.10.2017.

Wayfinding in Aging and Alzheimer’s Disease within a Virtual Senior Residence: Study Protocol

PubMed Central

DAVIS, Rebecca; OHMAN, Jennifer

2017-01-01

Aim To report a study protocol that examines the impact of adding salient cues within a virtual reality simulation of a senior residential building on wayfinding for older adults with and without Alzheimer’s disease. Background An early symptom of Alzheimer’s disease is the inability to find one’s way (wayfinding). Senior residential environments are especially difficult for wayfinding. Salient cues may be able to help persons with Alzheimer’s disease find their way more effectively so they can maintain independence. Design . A repeated measures, within and between subjects design. Methods This study was funded by the National Institutes of Health (August 2012). Older adults (n=40) with normal cognition and older adults with early stage Alzheimer’s disease/mild cognitive impairment (n=40) will try to find their way to a location repeatedly within a virtual reality simulation of senior residence. There are two environments: standard (no cues) and salient (multiple cues). Outcome measures include how often and how quickly participants find the target location in each cue condition. Discussion The results of this study have the potential to provide evidence for ways to make the environment more supportive for wayfinding for older adults with Alzheimer’s disease. This study is registered at Trialmatch.alz.org (Identifier 260425-5). PMID:26915997

Older Adult Experience of Online Diagnosis: Results From a Scenario-Based Think-Aloud Protocol

PubMed Central

2014-01-01

Background Searching for online information to interpret symptoms is an increasingly prevalent activity among patients, even among older adults. As older adults typically have complex health care needs, their risk of misinterpreting symptoms via online self-diagnosis may be greater. However, limited research has been conducted with older adults in the areas of symptom interpretation and human-computer interaction. Objective The intent of the study was to describe the processes that a sample of older adults may use to diagnose symptoms online as well as the processes that predict accurate diagnosis. Methods We conducted a series of “think-aloud” protocols with 79 adults aged 50 years or older. Participants received one of two vignettes that depicted symptoms of illness. Participants talked out loud about their thoughts and actions while attempting to diagnose the symptoms with and without the help of common Internet tools (Google and WebMD’s Symptom Checker). Think-aloud content was categorized using an adapted Q-sort and general inductive approach. We then compared the think-aloud content of participants who were accurate in their diagnosis with those who were not. Results Nineteen descriptive codes were identified from the think-aloud content. The codes touched upon Web navigation, attempts to organize and evaluate online health information, and strategies to diagnose symptoms. Participants most frequently relied on a strategy where they reviewed and then rejected the online diagnoses if they contained additional symptoms than those that were depicted in the vignette. Finally, participants who were inaccurate in their diagnosis reported being confused by the diagnosis task, lacking confidence in their diagnosis, and using their past experiences with illness to guide diagnosis more frequently than those participants who accurately diagnosed the symptoms. Conclusions Older adult participants tended to rely on matching strategies to interpret symptoms, but many

Comparison of Chest Pain Protocols for Electrocardiography-Gated Dual-Source Cardiothoracic CT in Children and Adults: The Effect of Tube Current Saturation on Radiation Dose Reduction

PubMed Central

2018-01-01

Objective To compare radiation doses between conventional and chest pain protocols using dual-source retrospectively electrocardiography (ECG)-gated cardiothoracic computed tomography (CT) in children and adults and assess the effect of tube current saturation on radiation dose reduction. Materials and Methods This study included 104 patients (16.6 ± 7.7 years, range 5–48 years) that were divided into two groups: those with and those without tube current saturation. The estimated radiation doses of retrospectively ECG-gated spiral cardiothoracic CT were compared between conventional, uniphasic, and biphasic chest pain protocols acquired with the same imaging parameters in the same patients by using paired t tests. Dose reduction percentages, patient ages, volume CT dose index values, and tube current time products per rotation were compared between the two groups by using unpaired t tests. A p value < 0.05 was considered significant. Results The volume CT dose index values of the biphasic chest pain protocol (10.8 ± 3.9 mGy) were significantly lower than those of the conventional protocol (12.2 ± 4.7 mGy, p < 0.001) and those of the uniphasic chest pain protocol (12.9 ± 4.9 mGy, p < 0.001). The dose-saving effect of biphasic chest pain protocol was significantly less with a saturated tube current (4.5 ± 10.2%) than with unsaturated tube current method (14.8 ± 11.5%, p < 0.001). In 76 patients using 100 kVp, patient age showed no significant differences between the groups with and without tube current saturation in all protocols (p > 0.05); the groups with tube current saturation showed significantly higher volume CT dose index values (p < 0.01) and tube current time product per rotation (p < 0.001) than the groups without tube current saturation in all protocols. Conclusion The radiation dose of dual-source retrospectively ECG-gated spiral cardiothoracic CT can be reduced by approximately 15% by using the biphasic chest pain protocol instead of the

Organ dose conversion coefficients for tube current modulated CT protocols for an adult population

NASA Astrophysics Data System (ADS)

Fu, Wanyi; Tian, Xiaoyu; Sahbaee, Pooyan; Zhang, Yakun; Segars, William Paul; Samei, Ehsan

2016-03-01

In computed tomography (CT), patient-specific organ dose can be estimated using pre-calculated organ dose conversion coefficients (organ dose normalized by CTDIvol, h factor) database, taking into account patient size and scan coverage. The conversion coefficients have been previously estimated for routine body protocol classes, grouped by scan coverage, across an adult population for fixed tube current modulated CT. The coefficients, however, do not include the widely utilized tube current (mA) modulation scheme, which significantly impacts organ dose. This study aims to extend the h factors and the corresponding dose length product (DLP) to create effective dose conversion coefficients (k factor) database incorporating various tube current modulation strengths. Fifty-eight extended cardiac-torso (XCAT) phantoms were included in this study representing population anatomy variation in clinical practice. Four mA profiles, representing weak to strong mA dependency on body attenuation, were generated for each phantom and protocol class. A validated Monte Carlo program was used to simulate the organ dose. The organ dose and effective dose was further normalized by CTDIvol and DLP to derive the h factors and k factors, respectively. The h factors and k factors were summarized in an exponential regression model as a function of body size. Such a population-based mathematical model can provide a comprehensive organ dose estimation given body size and CTDIvol. The model was integrated into an iPhone app XCATdose version 2, enhancing the 1st version based upon fixed tube current modulation. With the organ dose calculator, physicists, physicians, and patients can conveniently estimate organ dose.

An evidence-based gamified mHealth intervention for overweight young adults with maladaptive eating habits: study protocol for a randomized controlled trial.

PubMed

Podina, Ioana R; Fodor, Liviu A; Cosmoiu, Ana; Boian, Rareș

2017-12-12

Cognitive behavior therapy (CBT) is the first-line of treatment for overweight and obesity patients whose problems originate in maladaptive eating habits (e.g., emotional eating). However, in-person CBT is currently difficult to access by large segments of the population. The proposed SIGMA intervention (i.e., the Self-help, Integrated, and Gamified Mobile-phone Application) is a mHealth intervention based on CBT principles. It specifically targets overweight young adults with underlying maladaptive behaviors and cognitions regarding food. The SIGMA app was designed as a serious game and intended to work as a standalone app for weight maintenance or alongside a calorie-restrictive diet for weight loss. It uses a complex and novel scoring system that allows points earned within the game to be supplemented by points earned during outdoor activities with the help of an embedded pedometer. The efficacy of the SIGMA mHealth intervention will be investigated within a randomized, placebo-controlled trial. The intervention will be set to last 2 months with a 3-month follow-up. Selected participants will be young overweight adults with non-clinical maladaptive eating habits embodied by food cravings, binge eating, and emotional eating. The primary outcomes will be represented by changes in (1) self-reported maladaptive thoughts related to eating and body weight, (2) self-reported maladaptive eating behaviors in the range of urgent food cravings, emotional eating or binge eating, (3) as well as biased attentional processing of food items as indexed by reaction times. Secondary outcomes will be represented by changes in weight, Body Mass Index, general mood, and physical activity as indexed by the number of steps per day. Through an evidence-based cognitive behavioral approach and a user-friendly game interface, the SIGMA intervention offers a significant contribution to the development of a cost-effective and preventive self-help tool for young overweight adults with

"CAN Stop"--implementation and evaluation of a secondary group prevention for adolescent and young adult cannabis users in various contexts--study protocol.

PubMed

Baldus, Christiane; Miranda, Alejandra; Weymann, Nina; Reis, Olaf; Moré, Kerstin; Thomasius, Rainer

2011-04-18

Current research shows that overall numbers for cannabis use among adolescents and young adults dropped in recent years. However, this trend is much less pronounced in continuous cannabis use. With regard to the heightened risk for detrimental health- and development-related outcomes, adolescents and young adults with continuous cannabis use need special attention. The health services structure for adolescents and young adults with substance related problems in Germany, is multifaceted, because different communal, medical and judicial agencies are involved. This results in a rather decentralized organizational structure of the help system. This and further system-inherent characteristics make the threshold for young cannabis users rather high. Because of this, there is a need to establish evidence-based low-threshold help options for young cannabis users, which can be easily disseminated. Therefore, a training programme for young cannabis users (age 14-21) was developed in the "CAN Stop" project. Within the project, we seek to implement and evaluate the training programme within different institutions of the help system. The evaluation is sensitive to the different help systems and their specific prerequisites. Moreover, within this study, we also test the practicability of a training provision through laypersons. The CAN Stop study is a four-armed randomized wait-list controlled trial. The four arms are needed for the different help system settings, in which the CAN Stop training programme is evaluated: (a) the drug addiction aid and youth welfare system, (b) the out-patient medical system, (c) the in-patient medical system and (d) prisons for juvenile offenders. Data are collected at three points, before and after the training or a treatment as usual, and six months after the end of either intervention. The CAN Stop study is expected to provide an evidence-based programme for young cannabis users seeking to reduce or quit their cannabis use. Moreover, we seek to

"CAN Stop" - Implementation and evaluation of a secondary group prevention for adolescent and young adult cannabis users in various contexts - study protocol

PubMed Central

2011-01-01

Background Current research shows that overall numbers for cannabis use among adolescents and young adults dropped in recent years. However, this trend is much less pronounced in continuous cannabis use. With regard to the heightened risk for detrimental health- and development-related outcomes, adolescents and young adults with continuous cannabis use need special attention. The health services structure for adolescents and young adults with substance related problems in Germany, is multifaceted, because different communal, medical and judicial agencies are involved. This results in a rather decentralized organizational structure of the help system. This and further system-inherent characteristics make the threshold for young cannabis users rather high. Because of this, there is a need to establish evidence-based low-threshold help options for young cannabis users, which can be easily disseminated. Therefore, a training programme for young cannabis users (age 14-21) was developed in the "CAN Stop" project. Within the project, we seek to implement and evaluate the training programme within different institutions of the help system. The evaluation is sensitive to the different help systems and their specific prerequisites. Moreover, within this study, we also test the practicability of a training provision through laypersons. Methods/Design The CAN Stop study is a four-armed randomized wait-list controlled trial. The four arms are needed for the different help system settings, in which the CAN Stop training programme is evaluated: (a) the drug addiction aid and youth welfare system, (b) the out-patient medical system, (c) the in-patient medical system and (d) prisons for juvenile offenders. Data are collected at three points, before and after the training or a treatment as usual, and six months after the end of either intervention. Discussion The CAN Stop study is expected to provide an evidence-based programme for young cannabis users seeking to reduce or quit

The macular degeneration and aging study: Design and research protocol of a randomized trial for a psychosocial intervention with macular degeneration patients.

PubMed

Sörensen, Silvia; White, Katherine; Mak, Wingyun; Zanibbi, Katherine; Tang, Wan; O'Hearn, Amanda; Hegel, Mark T

2015-05-01

Age-related Macular Degeneration (AMD) is the leading cause of irreversible and predictable blindness among older adults with serious physical and mental health consequences. Visual impairment is associated with negative future outlook and depression and has serious consequences for older adults' quality of life and, by way of depression, on long-term survival. Psychosocial interventions have the potential to alleviate and prevent depression symptoms among older AMD patients. We describe the protocol of the Macular Degeneration and Aging Study, a randomized clinical trial of a psychosocial Preventive Problem-Solving Intervention. The intervention is aimed at enhancing well-being and future planning among older adults with macular degeneration by increasing preparation for future care. Adequate randomization and therapeutic fidelity were achieved. Current retention rates were acceptable, given the vulnerability of the population. Acceptability (adherence and satisfaction) was high. Given the high public health significance and impact on quality of life among older adults with vision loss, this protocol contributes a valid test of a promising intervention for maintaining mental and physical health in this population. Copyright © 2015 Elsevier Inc. All rights reserved.

The postcard intervention against depression among community-dwelling older adults: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Depression in older adults deteriorates quality of life and increases morbidity, mortality, and medical expenses. Medicine and social policy should work together to decrease this burden. Existing prevention studies are often based on time-consuming psychotherapies, which therefore are not feasible for a wide application at the community level. Postcard interventions have been shown to be effective for patients after hospitalization for major depression, drug overdose, or self-harm. This paper describes the protocol of a pragmatic, randomized controlled trial designed to examine the efficacy of a postcard intervention for depression among community-dwelling individuals aged 65 years or older. Methods/Design This is a pragmatic, non-blinded, parallel comparison, randomized controlled trial using Zelen’s design in a community setting. Participants will include community-dwelling older adults (aged 65 years or older) with limited social support (indicated by eating meals alone) and with symptoms of depression (scoring 4 or higher on the 15-item Geriatric Depression Scale (GDS)). The intervention will consist of sending postcards with handwritten messages and seasonal reports from a historical city to participants once a month for eight consecutive months. Self-addressed, stamped envelopes will be enclosed to facilitate non-obligatory replies. Primary outcomes will be changes in the GDS scores that are administered to all elderly inhabitants of the community every year as part of annual health checks. Secondary outcomes include quality of life as measured by a visual analogue scale, and self-rated basic and advanced activities of daily living. We will also examine the subjective sense of effectiveness of the intervention, recollection of the number of intervention mailings received, and the number of mailed replies as the index of the acceptability of the postcard intervention. The time × group interaction for two consecutive years will be analyzed using a

Impact of a Respiratory Therapy Assess-and-Treat Protocol on Adult Cardiothoracic ICU Readmissions.

PubMed

Dailey, Robert T; Malinowski, Thomas; Baugher, Mitchel; Rowley, Daniel D

2017-05-01

The purpose of this retrospective medical record review was to report on recidivism to the ICU among adult postoperative cardiac and thoracic patients managed with a respiratory therapy assess-and-treat (RTAT) protocol. Our primary null hypothesis was that there would be no difference in all-cause unexpected readmissions and escalations between the RTAT group and the physician-ordered respiratory care group. Our secondary null hypothesis was that there would be no difference in primary respiratory-related readmissions, ICU length of stay, or hospital length of stay. We reviewed 1,400 medical records of cardiac and thoracic postoperative subjects between January 2015 and October 2016. The RTAT is driven by a standardized patient assessment tool, which is completed by a registered respiratory therapist. The tool develops a respiratory severity score for each patient and directs interventions for bronchial hygiene, aerosol therapy, and lung inflation therapy based on an algorithm. The protocol period commenced on December 1, 2015, and continued through October 2016. Data relative to unplanned admissions to the ICU for all causes as well as respiratory-related causes were evaluated. There was a statistically significant difference in the all-cause unplanned ICU admission rate between the RTAT (5.8% [95% CI 4.3-7.9]) and the physician-ordered respiratory care (8.8% [95% CI 6.9-11.1]) groups ( P = .034). There was no statistically significant difference in respiratory-related unplanned ICU admissions with RTAT (36% [95% CI 22.7-51.6]) compared with the physician-ordered respiratory care (53% [95% CI 41.1-64.8]) group ( P = .09). The RTAT protocol group spent 1 d less in the ICU ( P < .001) and in the hospital ( P < .001). RTAT protocol implementation demonstrated a statistically significant reduction in all-cause ICU readmissions. The reduction in respiratory-related ICU readmissions did not reach statistical significance. Copyright © 2017 by Daedalus Enterprises.

Is Home-Based, High-Intensity Interval Training Cycling Feasible and Safe for Patients With Knee Osteoarthritis?: Study Protocol for a Randomized Pilot Study.

PubMed

Keogh, Justin W L; Grigg, Josephine; Vertullo, Christopher J

2017-03-01

Osteoarthritis (OA) is a degenerative joint disease affecting the knee joint of many middle-aged and older adults. As OA symptoms typically involve knee pain and stiffness, individuals with knee OA are often insufficiently physically active, have low levels of physical function, and are at increased risk of other comorbidities and reduced quality of life. While moderate-intensity continuous training (MICT) cycling is often recommended, little is known about the feasibility, safety, and benefits of high-intensity interval training (HIIT) cycling for this population, even though the feasibility, safety, and benefits of HIIT have been demonstrated in other chronic disease groups. The primary objective of this pilot study was to examine the feasibility and safety of home-based HIIT and MICT cycling in middle-aged and older adults with knee OA. A secondary objective was to gain some insight into the relative efficacy of HIIT and MICT for improving health status (pain, stiffness, and disability), muscle function, and body composition in this population. This study protocol is being published separately to allow a detailed description of the research methods, explain the rationale for choosing the methodological details, and to stimulate consideration of the best means to simulate a research protocol that is relevant to a real-life treatment environment. Randomized pilot study protocol. This trial sought to recruit 40 middle-aged and older adults with knee OA. Participants were randomly allocated to either continuous (MICT) or HIIT home-based cycle training programs, with both programs requiring the performance of 4 cycling sessions (approximately 25 minutes per session) each week. Participants were measured at baseline and postintervention (8 weeks). Feasibility and safety were assessed by adherence rate, dropout rate, and number of adverse events. The relative efficacy of the cycling programs was investigated by 2 knee OA health status questionnaires (Western Ontario

A web-based multidomain lifestyle intervention with connected devices for older adults: research protocol of the eMIND pilot randomized controlled trial.

PubMed

Pothier, Kristell; Soriano, G; Lussier, M; Naudin, A; Costa, N; Guyonnet, S; Piau, A; Ousset, P J; Nourhashemi, F; Vellas, B; de Souto Barreto, P

2018-01-24

Multidomain interventions composed of nutritional counseling, exercise and cognitive trainings have shown encouraging results as effective preventive strategies delaying age-related declines. However, these interventions are time- and resource-consuming. The use of Information and Communication Technologies (ICT) might facilitate the translation from research into real-world practice and reach a massive number of people. This article describes the protocol of the eMIND study, a randomized controlled trial (RCT) using a web-based multidomain intervention for older adults. One hundred and twenty older adults (≥ 65 years), with a spontaneous memory complaint, will be randomly assigned to a six-month web-based multidomain (nutritional counseling, physical and cognitive trainings) intervention group with a connected accelerometer (number of steps, energy expenditure), or to a control group with access to general information on healthy aging plus the accelerometer, but no access to the multidomain intervention. The main outcome is the feasibility/acceptability of the web-based intervention. Secondary clinical outcomes include: cognitive functions, physical performance, nutritional status and cost-effectiveness. We expect a high amount of adherers (ie, > 75% compliance to the protocol) to reflect the feasibility. Acceptability, assessed through interviews, should allow us to understand motivators and barriers to this ICT intervention. We also expect to provide data on its effects on various clinical outcomes and efficiency. The eMIND study will provide crucial information to help developing a future and larger web-based multidomain lifestyle RCT, which should facilitate the translation of this ICT intervention from the research world into real-life clinical practice for the healthcare of older adults.

The Benefit of Remote Microphones Using Four Wireless Protocols.

PubMed

Rodemerk, Krishna S; Galster, Jason A

2015-09-01

Many studies have reported the speech recognition benefits of a personal remote microphone system when used by adult listeners with hearing loss. The advance of wireless technology has allowed for many wireless audio transmission protocols. Some of these protocols interface with commercially available hearing aids. As a result, commercial remote microphone systems use a variety of different protocols for wireless audio transmission. It is not known how these systems compare, with regard to adult speech recognition in noise. The primary goal of this investigation was to determine the speech recognition benefits of four different commercially available remote microphone systems, each with a different wireless audio transmission protocol. A repeated-measures design was used in this study. Sixteen adults, ages 52 to 81 yr, with mild to severe sensorineural hearing loss participated in this study. Participants were fit with three different sets of bilateral hearing aids and four commercially available remote microphone systems (FM, 900 MHz, 2.4 GHz, and Bluetooth(®) paired with near-field magnetic induction). Speech recognition scores were measured by an adaptive version of the Hearing in Noise Test (HINT). The participants were seated both 6 and 12' away from the talker loudspeaker. Participants repeated HINT sentences with and without hearing aids and with four commercially available remote microphone systems in both seated positions with and without contributions from the hearing aid or environmental microphone (24 total conditions). The HINT SNR-50, or the signal-to-noise ratio required for correct repetition of 50% of the sentences, was recorded for all conditions. A one-way repeated measures analysis of variance was used to determine statistical significance of microphone condition. The results of this study revealed that use of the remote microphone systems statistically improved speech recognition in noise relative to unaided and hearing aid-only conditions

Evaluation of anaesthetic protocols for laboratory adult zebrafish (Danio rerio).

PubMed

Martins, Tânia; Diniz, Enoque; Félix, Luís M; Antunes, Luís

2018-01-01

In the last decades, the use of zebrafish (Danio rerio) in biomedical research has increased. Anaesthesia is daily used in fish during experimental procedures to avoid discomfort, stress or pain. Also, fish welfare and the reliability of results can be compromised if an unsuitable anaesthetic protocol is used. Therefore, we aimed to refine anaesthetic protocols to be used in adult zebrafish by evaluating the efficacy of different anaesthetics, used alone or in combination. For that, zebrafish were randomly assigned to 8 different groups: 100 μg/mLMS-222 (MS); 0.2 μg/mL etomidate (E); 0.2 μg/mL etomidate + 100 μg/mL lidocaine (E+L); 1.25 μg/mL propofol (P); 1.25 μg/mL propofol + 100 μg/mL lidocaine (P+L); 100 μg/mL ketamine (K); 100 μg/mL ketamine + 1.25 μg/mL medetomidine (K+M); and 100 μg/mL ketamine + 1.25 μg/mL medetomidine/3.125 μg/mL atipamezole (K+M/A). The animals were placed in an anaesthetic water bath, then, the following parameters were registered: time for equilibrium loss and anaesthesia induction, loss of sensitivity to soft and painful stimuli, respiratory rate, recovery time, and activity after recovery. The combined forms of E+L, P+L and K+M were the fastest to induce a surgical anaesthetic stage. Nevertheless, E+L induced respiratory depression, while K+M was shown to have the longer recovery time compared to MS-222, even when atipamezole was added. In conclusion, the P+L combination was shown to provide good anaesthesia with analgesia, without causing a major respiratory depression, providing as well a quick recovery, similar to MS-222.

"Young people, adult worries": RCT of an internet-based self-support method "Feel the ViBe" for children, adolescents and young adults exposed to family violence, a study protocol.

PubMed

van Rosmalen-Nooijens, Karin A W L; Prins, Judith B; Vergeer, Marianne; Wong, Sylvie H Lo Fo; Lagro-Janssen, Antoine L M

2013-03-15

Violence in families affects children. Exposure to violence is seen as child abuse. Figures show that about one third of children exposed to violence become victim or perpetrator in their adult life: known as intergenerational transmission. Violence also affects sexual and reproductive health. To prevent problems in adult life, children need help and support. However, while trying to protect their parents, children often do not seek help, or perceive the threshold as too high. Since almost all children of the current generation have access to the internet, an online intervention will make help better available for this target group. In 2011, an internet-based self-support method for children, adolescents and young adults exposed to family violence was developed in the Netherlands: "Feel the ViBe". The intervention was developed in close collaboration with the target group. This article describes the protocol of the RCT to study the effectiveness of this intervention. This study is a randomized controlled trial using the method of minimization to randomize the participants in two parallel groups with a 1:1 allocation ratio, being an intervention group, having access to "Feel the ViBe" and usual care (UC), and a control group, having access to minimally enhanced usual care (mEUC) followed by access to the intervention after twelve weeks. Outcomes are measured with questionnaires on PTSD symptoms, mental health and sexual and reproductive health. Routine Outcome Measurement (ROM) will be used to measure a direct effect of participating in the intervention. Data from a web evaluation questionnaire (WEQ), user statistics and qualitative analysis of online data will be used to support the findings. To compare results Cohen's d effect sizes will be used. A RCT and process evaluation will test effectiveness and provide information of how the effects can be explained, how the intervention meets the expectation of participants and which possible barriers and facilitators for

Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: study protocol for a randomized controlled trial.

PubMed

Bailey, Jeanette; Lelijveld, Natasha; Marron, Bethany; Onyoo, Pamela; Ho, Lara S; Manary, Mark; Briend, André; Opondo, Charles; Kerac, Marko

2018-04-24

Acute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies. The Combined Protocol for Acute Malnutrition Study (ComPAS) aims to simplify and unify the treatment of uncomplicated severe and moderate acute malnutrition (SAM and MAM) for children 6-59 months into one protocol in order to improve the global coverage, quality, continuity of care and cost-effectiveness of acute malnutrition treatment in resource-constrained settings. This study is a multi-site, cluster randomized non-inferiority trial with 12 clusters in Kenya and 12 clusters in South Sudan. Participants are 3600 children aged 6-59 months with uncomplicated acute malnutrition. This study will evaluate the impact of a simplified and combined protocol for the treatment of SAM and MAM compared to the standard protocol, which is the national treatment protocol in each country. We will assess recovery rate as a primary outcome and coverage, defaulting, death, length of stay, average weekly weight gain and average weekly mid-upper arm circumference (MUAC) gain as secondary outcomes. Recovery rate is defined across both treatment arms as MUAC ≥125 mm and no oedema for two consecutive visits. Per-protocol and intention-to-treat analyses will be conducted. If the combined protocol is shown to be non-inferior to the standard protocol, updating guidelines to use the combined protocol would eliminate the need for separate products, resources and procedures for MAM treatment. This would likely be more cost-effective, increase availability of services, enable earlier case finding and treatment before deterioration of MAM into SAM, promote better continuity of care and improve community perceptions of the programme. ISRCTN, ISRCTN30393230 . Registered on 16 March 2017.

Restoration of Oral Function for Adult Edentulous Patients with Ectodermal Dysplasia: A Prospective Preliminary Clinical Study.

PubMed

Wu, Yiqun; Wang, Xu Dong; Wang, Feng; Huang, Wei; Zhang, Zhiyong; Zhang, Zhiyuan; Kaigler, Darnell; Zou, Duohong

2015-10-01

Therapy with zygomatic implants (ZIs) or conventional implants (CIs) has proven to be an effective method to restore oral function for systemically healthy patients. However, it is still a major challenge to fully restore oral function to edentulous adult patients with ectodermal dysplasia (ED). The aim of this study was to determine an effective treatment protocol for restoring oral function using ZIs and CIs to edentulous adult ED patients. Ten edentulous adult ED patients were treated in this study. The treatment protocol involved the following: (1) bone augmentation in the region of the anterior teeth; (2) placement of two ZIs and four CIs in the maxilla, and four CIs in the mandible; (3) fabrication of dental prosthesis; and (4) psychological and oral education. Following treatment of these patients, implant success rates, biological complications, patient satisfaction, and psychological changes were recorded. Although there was evidence of bone graft resorption in the maxilla, bone augmentation of the mandible was successful in all patients. Nine CIs in the maxilla failed and were removed. All ZIs were successful, and the CIs success rates were 77.50% in the maxilla and 100% in the mandible, with a mean of 88.75%. The mean peri-implant bone resorption for the CIs ranged from 1.3 ± 0.4 mm to 1.8 ± 0.6 mm, and four cases exhibited gingival hyperplasia in the maxilla and mandible. One hundred percent of the patients were satisfied with the restoration of their oral function, and >50% of the patients exhibited enhanced self-confidence and self-esteem. This study demonstrates that oral function can be restored in edentulous adult ED patients using a comprehensive and systematic treatment protocol involving psychological and oral education, bone augmentation, implant placement, and denture fabrication. Despite these positive outcomes, bone augmentation remains challenging in the anterior region of the maxilla for edentulous adult ED patients. © 2015

Social facilitation maintenance treatment for adults with obesity: study protocol for a randomised-controlled feasibility study (SFM study).

PubMed

Hilbert, Anja

2016-08-31

The long-term success of non-surgical weight loss treatment in adults with obesity is limited by substantial relapse, and only a few evidence-based weight loss maintenance treatments exist. This clinical trial investigates the feasibility and efficacy of a social facilitation maintenance programme for weight loss maintenance, tailored to meet the needs of obese adults who have undergone a lifestyle weight loss intervention. In a single-centre, open feasibility trial, 72 adults currently or previously obese or overweight who have undergone a lifestyle weight loss intervention are centrally randomised to 4 months of social facilitation maintenance treatment or treatment as a usual control condition. In 16 outpatient group sessions, the social facilitation maintenance treatment, based on a socioecological model and on evidence supporting social facilitation as a key process in maintaining weight loss, focuses on promoting interpersonal relationships to build up a healthy lifestyle for long-term weight loss maintenance. Primary outcome is the amount of weight regain at 6-month follow-up, compared with pre-treatment weight, derived from measured body weight. Secondary outcomes address feasibility, including recruitment, attrition, assessment non-completion, compliance and patients' programme evaluation; and in comparison with pre-weight loss maintenance, social and interpersonal functioning, eating behaviour and physical activity, psychological and physical symptoms, body composition and risk of comorbidity, and quality of life at post-treatment and follow-up assessments. The study was approved by the Ethical Committee at the University of Leipzig (165-13-15072013). The study results will be disseminated through peer-reviewed publications. DRKS00005182. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Feasibility of exercising adults with asthma: a randomized pilot study.

PubMed

Boyd, Amy; Yang, Celeste T; Estell, Kim; Ms, Craig Tuggle; Gerald, Lynn B; Dransfield, Mark; Bamman, Marcas; Bonner, James; Atkinson, T Prescott; Schwiebert, Lisa M

2012-08-03

Aerobic exercise appears to have clinical benefits for many asthmatics, yet a complete understanding of the mechanisms underlying these benefits has not been elucidated at this time. The objective of this study was to determine feasibility for a larger, future study that will define the effect of aerobic exercise on cellular, molecular, and functional measures in adults with mild-moderate asthma. Recruited subjects were randomized into usual care (sedentary) or usual care with moderate intensity aerobic exercise treatment groups. Nineteen adults with mild-moderate asthma but without a recent history of exercise were recruited at the UAB Lung Health Center, Birmingham, AL. The exercise group underwent a 12 week walking program exercising at 60 - 75% of maximum heart rate (HRmax). Subjects self-monitored HRmax levels using heart rate monitors; exercise diaries and recreation center sign-in logs were also used. Functional measures, including lung function and asthma control scores, were evaluated for all subjects at pre- and post-study time-points; fitness measures were also assessed for subjects in the exercise group. Peripheral blood and nasal lavage fluid were collected from all subjects at pre- and post-study visits in order to evaluate cellular and molecular measures, including cell differentials and eosinophilic cationic protein (ECP). Sixteen subjects completed the prescribed protocol. Results show that subjects randomized to the exercise group adhered well (80%) to the exercise prescription and exhibited a trend toward improved fitness levels upon study completion. Both groups exhibited improvements in ACQ scores. No changes were observed in lung function (FEV1, FEV1/FVC), cell differentials, or ECP between groups. Results indicate that a moderate intensity aerobic exercise training program may improve asthma control and fitness levels without causing asthma deterioration in adult asthmatics. As such, these findings demonstrate the feasibility of the study

Emergency Department Pain Management in Adult Patients With Traumatic Injuries Before and After Implementation of a Nurse-Initiated Pain Treatment Protocol Utilizing Fentanyl for Severe Pain.

PubMed

Ridderikhof, Milan L; Schyns, Frederick J; Schep, Niels W; Lirk, Philipp; Hollmann, Markus W; Goslings, J Carel

2017-04-01

Pain management in the emergency department (ED) remains suboptimal. Nursing staff protocols could improve this, but studies show divergent results. Our aim was to evaluate a nurse-initiated pain-management protocol in adult patients with traumatic injuries in the short and in the long term, utilizing fentanyl for severe pain. In this pre-post implementation study, ED patients were included during three periods. The protocol allowed nurses to administer acetaminophen, non-steroidal anti-inflammatory drugs, or fentanyl autonomously, based on Numeric Rating Scale pain scores. Primary outcome was frequency of analgesic administration at 6 and 18 months after implementation. Secondary outcomes were pain awareness, occurrence of adverse events, and pain treatment after discharge. Five hundred and twelve patients before implementation were compared with 507 and 468 patients at 6 and 18 months after implementation, respectively. Analgesic administration increased significantly at 18 months (from 29% to 36%; p = 0.016), not at 6 months (33%; p = 0.19) after implementation. Pain awareness increased from 30% to 51% (p = 0.00) at 6 months and to 56% (p = 0.00) at 18 months, due to a significant increase in pain assessment: 3% to 30% (p = 0.00) and 32% (p = 0.00), respectively. Post-discharge pain treatment increased significantly at 18 months compared to baseline (from 25% to 33%; p = 0.016) and to 6 months (from 24% to 33%; p = 0.004). No adverse events were recorded. Implementation of a nurse-initiated pain-management protocol only increases analgesic administration in adult patients with traumatic injuries in the long term. Auditing might have promoted adherence. Pain awareness increases significantly in the short and the long term. Copyright © 2016 Elsevier Inc. All rights reserved.

Walk well: a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol

PubMed Central

2013-01-01

Background Walking interventions have been shown to have a positive impact on physical activity (PA) levels, health and wellbeing for adult and older adult populations. There has been very little work carried out to explore the effectiveness of walking interventions for adults with intellectual disabilities. This paper will provide details of the Walk Well intervention, designed for adults with intellectual disabilities, and a randomised controlled trial (RCT) to test its effectiveness. Methods/design This study will adopt a RCT design, with participants allocated to the walking intervention group or a waiting list control group. The intervention consists of three PA consultations (baseline, six weeks and 12 weeks) and an individualised 12 week walking programme. A range of measures will be completed by participants at baseline, post intervention (three months from baseline) and at follow up (three months post intervention and six months from baseline). All outcome measures will be collected by a researcher who will be blinded to the study groups. The primary outcome will be steps walked per day, measured using accelerometers. Secondary outcome measures will include time spent in PA per day (across various intensity levels), time spent in sedentary behaviour per day, quality of life, self-efficacy and anthropometric measures to monitor weight change. Discussion Since there are currently no published RCTs of walking interventions for adults with intellectual disabilities, this RCT will examine if a walking intervention can successfully increase PA, health and wellbeing of adults with intellectual disabilities. Trial registration ISRCTN: ISRCTN50494254 PMID:23816316

BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill.

PubMed

Lichtenstein, Daniel A

2015-06-01

This review article describes two protocols adapted from lung ultrasound: the bedside lung ultrasound in emergency (BLUE)-protocol for the immediate diagnosis of acute respiratory failure and the fluid administration limited by lung sonography (FALLS)-protocol for the management of acute circulatory failure. These applications require the mastery of 10 signs indicating normal lung surface (bat sign, lung sliding, A-lines), pleural effusions (quad and sinusoid sign), lung consolidations (fractal and tissue-like sign), interstitial syndrome (lung rockets), and pneumothorax (stratosphere sign and the lung point). These signs have been assessed in adults, with diagnostic accuracies ranging from 90% to 100%, allowing consideration of ultrasound as a reasonable bedside gold standard. In the BLUE-protocol, profiles have been designed for the main diseases (pneumonia, congestive heart failure, COPD, asthma, pulmonary embolism, pneumothorax), with an accuracy > 90%. In the FALLS-protocol, the change from A-lines to lung rockets appears at a threshold of 18 mm Hg of pulmonary artery occlusion pressure, providing a direct biomarker of clinical volemia. The FALLS-protocol sequentially rules out obstructive, then cardiogenic, then hypovolemic shock for expediting the diagnosis of distributive (usually septic) shock. These applications can be done using simple grayscale machines and one microconvex probe suitable for the whole body. Lung ultrasound is a multifaceted tool also useful for decreasing radiation doses (of interest in neonates where the lung signatures are similar to those in adults), from ARDS to trauma management, and from ICUs to points of care. If done in suitable centers, training is the least of the limitations for making use of this kind of visual medicine.

'Moving on and feeling good': a feasibility study to explore the lifestyle behaviours of young adults with intellectual disabilities as they transition from school to adulthood-a study protocol.

PubMed

Mitchell, Fiona; Jahoda, Andrew; Hankey, Catherine; Matthews, Lynsay; Murray, Heather; Melville, Craig

2016-01-01

The transition from adolescence to adulthood is a 'high-risk' period for weight gain in the general population. There is speculation that this may also be a risk period for adults with intellectual disabilities; however, there has been no research which has monitored change in health indicators. Since adults with intellectual disabilities have higher rates of obesity and engage in more sedentary behaviour and less physical activity than the general population, there is a need to understand more about the lifestyle behaviours of this population during the transition to adulthood. This protocol paper will provide details of the moving on and feeling good feasibility study, designed for young people with intellectual disabilities. A multi-point recruitment strategy will be used to recruit 30 participants with a mild-moderate level of intellectual disability. The aim of the feasibility study is to examine the feasibility of recruitment, participant retention and the measurement of relevant health behaviour outcomes. The study will assess the feasibility of monitoring weight, diet and physical activity levels in adolescents over a 12-month transitional period from school to adult life. This mixed method study will provide insight into the lives of young people with intellectual disabilities and will examine the use of Walker et al.'s social-ecological approach to promote self-determination specific to lifestyle behaviours, during this transition period. Baseline data will be collected during the final year of school, with follow-up data collection at 6 and 12 months. Anthropometric (weight, height, waist and hip circumference), objective physical activity measures (7-day accelerometer wear) and dietary and choice measures will be collected at each time point to assess the feasibility of measuring diet patterns, food frequency, physical activity and BMI. Furthermore, ten participants will be selected for short semi-structured scoping interviews at baseline and 12-month

Nutrition and dietary intake and their association with mortality and hospitalisation in adults with chronic kidney disease treated with haemodialysis: protocol for DIET-HD, a prospective multinational cohort study.

PubMed

Palmer, Suetonia C; Ruospo, Marinella; Campbell, Katrina L; Garcia Larsen, Vanessa; Saglimbene, Valeria; Natale, Patrizia; Gargano, Letizia; Craig, Jonathan C; Johnson, David W; Tonelli, Marcello; Knight, John; Bednarek-Skublewska, Anna; Celia, Eduardo; Del Castillo, Domingo; Dulawa, Jan; Ecder, Tevfik; Fabricius, Elisabeth; Frazão, João Miguel; Gelfman, Ruben; Hoischen, Susanne Hildegard; Schön, Staffan; Stroumza, Paul; Timofte, Delia; Török, Marietta; Hegbrant, Jörgen; Wollheim, Charlotta; Frantzen, Luc; Strippoli, G F M

2015-03-20

Adults with end-stage kidney disease (ESKD) treated with haemodialysis experience mortality of between 15% and 20% each year. Effective interventions that improve health outcomes for long-term dialysis patients remain unproven. Novel and testable determinants of health in dialysis are needed. Nutrition and dietary patterns are potential factors influencing health in other health settings that warrant exploration in multinational studies in men and women treated with dialysis. We report the protocol of the "DIETary intake, death and hospitalisation in adults with end-stage kidney disease treated with HaemoDialysis (DIET-HD) study," a multinational prospective cohort study. DIET-HD will describe associations of nutrition and dietary patterns with major health outcomes for adults treated with dialysis in several countries. DIET-HD will recruit approximately 10,000 adults who have ESKD treated by clinics administered by a single dialysis provider in Argentina, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain, Sweden and Turkey. Recruitment will take place between March 2014 and June 2015. The study has currently recruited 8000 participants who have completed baseline data. Nutritional intake and dietary patterns will be measured using the Global Allergy and Asthma European Network (GA(2)LEN) food frequency questionnaire. The primary dietary exposures will be n-3 and n-6 polyunsaturated fatty acid consumption. The primary outcome will be cardiovascular mortality and secondary outcomes will be all-cause mortality, infection-related mortality and hospitalisation. The study is approved by the relevant Ethics Committees in participating countries. All participants will provide written informed consent and be free to withdraw their data at any time. The findings of the study will be disseminated through peer-reviewed journals, conference presentations and to participants via regular newsletters. We expect that the DIET-HD study will inform large pragmatic

A literature review: polypharmacy protocol for primary care.

PubMed

Skinner, Mary

2015-01-01

The purpose of this literature review is to critically evaluate published protocols on polypharmacy in adults ages 65 and older that are currently used in primary care settings that may potentially lead to fewer adverse drug events. A review of OVID, CINAHL, EBSCO, Cochrane Library, Medline, and PubMed databases was completed using the following key words: protocol, guideline, geriatrics, elderly, older adult, polypharmacy, and primary care. Inclusion criteria were: articles in medical, nursing, and pharmacology journals with an intervention, protocol, or guideline addressing polypharmacy that lead to fewer adverse drug events. Qualitative and quantitative studies were included. Exclusion criteria were: publications prior to the year 1992. A gap exists in the literature. No standardized protocol for addressing polypharmacy in the primary care setting was found. Mnemonics, algorithms, clinical practice guidelines, and clinical strategies for addressing polypharmacy in a variety of health care settings were found throughout the literature. Several screening instruments for use in primary care to assess potentially inappropriate prescription of medications in the elderly, such as the Beers Criteria and the STOPP screening tool, were identified. However, these screening instruments were not included in a standardized protocol to manage polypharmacy in primary care. Polypharmacy in the elderly is a critical problem that may result in adverse drug events such as falls, hospitalizations, and increased expenditures for both the patient and the health care system. No standardized protocols to address polypharmacy specific to the primary care setting were identified in this review of the literature. Given the growing population of elderly in this country and the high number of medications they consume, it is critical to focus on the utilization of a standardized protocol to address the potential harm of polypharmacy in the primary care setting and evaluate its effects on

Structured Transition Protocol for Children with Cystinosis

PubMed Central

Raina, Rupesh; Wang, Joseph; Krishnappa, Vinod

2017-01-01

The transition from pediatric to adult medical services has a greater impact on the care of adolescents or young adults with chronic diseases such as cystinosis. This transition period is a time of psychosocial development and new responsibilities placing these patients at increased risk of non-adherence. This can lead to serious adverse effects such as graft loss and progression of the disease. Our transition protocol will provide patients, families, physicians, and all those involved a structured guide to transitioning cystinosis patients. This structured protocol depends on four areas of competency: Recognition, Insight, Self-reliance, and Establishment of healthy habits (RISE). This protocol has not been tested and therefore challenges not realized. With a focus on medical, social, and educational/vocational aspects, we aim to improve transition for cystinosis patients in all aspects of their lives. PMID:28913329

CT protocol management: simplifying the process by using a master protocol concept.

PubMed

Szczykutowicz, Timothy P; Bour, Robert K; Rubert, Nicholas; Wendt, Gary; Pozniak, Myron; Ranallo, Frank N

2015-07-08

This article explains a method for creating CT protocols for a wide range of patient body sizes and clinical indications, using detailed tube current information from a small set of commonly used protocols. Analytical expressions were created relating CT technical acquisition parameters which can be used to create new CT protocols on a given scanner or customize protocols from one scanner to another. Plots of mA as a function of patient size for specific anatomical regions were generated and used to identify the tube output needs for patients as a function of size for a single master protocol. Tube output data were obtained from the DICOM header of clinical images from our PACS and patient size was measured from CT localizer radiographs under IRB approval. This master protocol was then used to create 11 additional master protocols. The 12 master protocols were further combined to create 39 single and multiphase clinical protocols. Radiologist acceptance rate of exams scanned using the clinical protocols was monitored for 12,857 patients to analyze the effectiveness of the presented protocol management methods using a two-tailed Fisher's exact test. A single routine adult abdominal protocol was used as the master protocol to create 11 additional master abdominal protocols of varying dose and beam energy. Situations in which the maximum tube current would have been exceeded are presented, and the trade-offs between increasing the effective tube output via 1) decreasing pitch, 2) increasing the scan time, or 3) increasing the kV are discussed. Out of 12 master protocols customized across three different scanners, only one had a statistically significant acceptance rate that differed from the scanner it was customized from. The difference, however, was only 1% and was judged to be negligible. All other master protocols differed in acceptance rate insignificantly between scanners. The methodology described in this paper allows a small set of master protocols to be

CT protocol management: simplifying the process by using a master protocol concept

PubMed Central

Bour, Robert K.; Rubert, Nicholas; Wendt, Gary; Pozniak, Myron; Ranallo, Frank N.

2015-01-01

This article explains a method for creating CT protocols for a wide range of patient body sizes and clinical indications, using detailed tube current information from a small set of commonly used protocols. Analytical expressions were created relating CT technical acquisition parameters which can be used to create new CT protocols on a given scanner or customize protocols from one scanner to another. Plots of mA as a function of patient size for specific anatomical regions were generated and used to identify the tube output needs for patients as a function of size for a single master protocol. Tube output data were obtained from the DICOM header of clinical images from our PACS and patient size was measured from CT localizer radiographs under IRB approval. This master protocol was then used to create 11 additional master protocols. The 12 master protocols were further combined to create 39 single and multiphase clinical protocols. Radiologist acceptance rate of exams scanned using the clinical protocols was monitored for 12,857 patients to analyze the effectiveness of the presented protocol management methods using a two‐tailed Fisher's exact test. A single routine adult abdominal protocol was used as the master protocol to create 11 additional master abdominal protocols of varying dose and beam energy. Situations in which the maximum tube current would have been exceeded are presented, and the trade‐offs between increasing the effective tube output via 1) decreasing pitch, 2) increasing the scan time, or 3) increasing the kV are discussed. Out of 12 master protocols customized across three different scanners, only one had a statistically significant acceptance rate that differed from the scanner it was customized from. The difference, however, was only 1% and was judged to be negligible. All other master protocols differed in acceptance rate insignificantly between scanners. The methodology described in this paper allows a small set of master protocols to be

Acute Myeloid Leukemia in Adolescents and Young Adults Treated in Pediatric and Adult Departments in the Nordic Countries.

PubMed

Wennström, Lovisa; Edslev, Pernille Wendtland; Abrahamsson, Jonas; Nørgaard, Jan Maxwell; Fløisand, Yngvar; Forestier, Erik; Gustafsson, Göran; Heldrup, Jesper; Hovi, Liisa; Jahnukainen, Kirsi; Jonsson, Olafur Gisli; Lausen, Birgitte; Palle, Josefine; Zeller, Bernward; Holmberg, Erik; Juliusson, Gunnar; Stockelberg, Dick; Hasle, Henrik

2016-01-01

Studies on adolescents and young adults with acute lymphoblastic leukemia suggest better results when using pediatric protocols for adult patients, while corresponding data for acute myeloid leukemia (AML) are limited. We investigated disease characteristics and outcome for de novo AML patients 10-30 years old treated in pediatric or adult departments. We included 166 patients 10-18 years of age with AML treated according to the pediatric NOPHO-protocols (1993-2009) compared with 253 patients aged 15-30 years treated in hematology departments (1996-2009) in the Nordic countries. The incidence of AML was 4.9/million/year for the age group 10-14 years, 6.5 for 15-18 years, and 6.9 for 19-30 years. Acute promyelocytic leukemia (APL) was more frequent in adults and in females of all ages. Pediatric patients with APL had similar overall survival as pediatric patients without APL. Overall survival at 5 years was 60% (52-68%) for pediatric patients compared to 65% (58-70%) for adult patients. Cytogenetics and presenting white blood cell count were the only independent prognostic factors for overall survival. Age was not an independent prognostic factor. No difference was found in outcome for AML patients age 10-30 years treated according to pediatric as compared to adult protocols. © 2015 Wiley Periodicals, Inc.

Sources of Variation in a Two-Step Monitoring Protocol for Species Clustered in Conspicuous Points: Dolichotis patagonum as a Case Study.

PubMed

Alonso Roldán, Virginia; Bossio, Luisina; Galván, David E

2015-01-01

In species showing distributions attached to particular features of the landscape or conspicuous signs, counts are commonly made by making focal observations where animals concentrate. However, to obtain density estimates for a given area, independent searching for signs and occupancy rates of suitable sites is needed. In both cases, it is important to estimate detection probability and other possible sources of variation to avoid confounding effects on measurements of abundance variation. Our objective was to assess possible bias and sources of variation in a two-step protocol in which random designs were applied to search for signs while continuously recording video cameras were used to perform abundance counts where animals are concentrated, using mara (Dolichotis patagonum) as a case study. The protocol was successfully applied to maras within the Península Valdés protected area, given that the protocol was logistically suitable, allowed warrens to be found, the associated adults to be counted, and the detection probability to be estimated. Variability was documented in both components of the two-step protocol. These sources of variation should be taken into account when applying this protocol. Warren detectability was approximately 80% with little variation. Factors related to false positive detection were more important than imperfect detection. The detectability for individuals was approximately 90% using the entire day of observations. The shortest sampling period with a similar detection capacity than a day was approximately 10 hours, and during this period, the visiting dynamic did not show trends. For individual mara, the detection capacity of the camera was not significantly different from the observer during fieldwork. The presence of the camera did not affect the visiting behavior of adults to the warren. Application of this protocol will allow monitoring of the near-threatened mara providing a minimum local population size and a baseline for

Study of inhaler technique in asthma patients: differences between pediatric and adult patients

PubMed Central

Manríquez, Pablo; Acuña, Ana María; Muñoz, Luis; Reyes, Alvaro

2015-01-01

Objective: Inhaler technique comprises a set of procedures for drug delivery to the respiratory system. The oral inhalation of medications is the first-line treatment for lung diseases. Using the proper inhaler technique ensures sufficient drug deposition in the distal airways, optimizing therapeutic effects and reducing side effects. The purposes of this study were to assess inhaler technique in pediatric and adult patients with asthma; to determine the most common errors in each group of patients; and to compare the results between the two groups. Methods: This was a descriptive cross-sectional study. Using a ten-step protocol, we assessed inhaler technique in 135 pediatric asthma patients and 128 adult asthma patients. Results: The most common error among the pediatric patients was failing to execute a 10-s breath-hold after inhalation, whereas the most common error among the adult patients was failing to exhale fully before using the inhaler. Conclusions: Pediatric asthma patients appear to perform most of the inhaler technique steps correctly. However, the same does not seem to be true for adult patients. PMID:26578130

Toward onset prevention of cognitive decline in adults with Down syndrome (the TOP-COG study): study protocol for a randomized controlled trial.

PubMed

Cooper, Sally-Ann; Caslake, Muriel; Evans, Jonathan; Hassiotis, Angela; Jahoda, Andrew; McConnachie, Alex; Morrison, Jill; Ring, Howard; Starr, John; Stiles, Ciara; Sullivan, Frank

2014-06-03

Early-onset dementia is common in Down syndrome adults, who have trisomy 21. The amyloid precursor protein gene is on chromosome 21, and so is over-expressed in Down syndrome, leading to amyloid β (Aβ) over-production, a major upstream pathway leading to Alzheimer disease (AD). Statins (microsomal 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors), have pleiotropic effects including potentially increasing brain amyloid clearance, making them plausible agents to reduce AD risk. Animal models, human observational studies, and small scale trials support this rationale, however, there are no AD primary prevention trials in Down syndrome adults. In this study we study aim to inform the design of a full-scale primary prevention trial. TOP-COG is a feasibility and pilot double-blind randomized controlled trial (RCT), with a nested qualitative study, conducted in the general community. About 60 Down syndrome adults, aged ≥50 will be included. The intervention is oral simvastatin 40 mg at night for 12 months, versus placebo. The primary endpoint is recruitment and retention rates. Secondary endpoints are (1) tolerability and safety; (2) detection of the most sensitive neurocognitive instruments; (3) perceptions of Down syndrome adults and caregivers on whether to participate, and assessment experiences; (4) distributions of cognitive decline, adaptive behavior, general health/quality of life, service use, caregiver strain, and sample size implications; (5) whether Aβ42/Aβ40 is a cognitive decline biomarker. We will describe percentages recruited from each source, the number of contacts to achieve this, plus recruitment rate by general population size. We will calculate summary statistics with 90% confidence limits where appropriate, for each study outcome as a whole, by treatment group and in relation to baseline age, cognitive function, cholesterol and other characteristics. Changes over time will be summarized graphically. The sample size for a definitive

“Young people, adult worries”: RCT of an internet-based self-support method “Feel the ViBe” for children, adolescents and young adults exposed to family violence, a study protocol

PubMed Central

2013-01-01

Background Violence in families affects children. Exposure to violence is seen as child abuse. Figures show that about one third of children exposed to violence become victim or perpetrator in their adult life: known as intergenerational transmission. Violence also affects sexual and reproductive health. To prevent problems in adult life, children need help and support. However, while trying to protect their parents, children often do not seek help, or perceive the threshold as too high. Since almost all children of the current generation have access to the internet, an online intervention will make help better available for this target group. In 2011, an internet-based self-support method for children, adolescents and young adults exposed to family violence was developed in the Netherlands: “Feel the ViBe”. The intervention was developed in close collaboration with the target group. This article describes the protocol of the RCT to study the effectiveness of this intervention. Methods/design This study is a randomized controlled trial using the method of minimization to randomize the participants in two parallel groups with a 1:1 allocation ratio, being an intervention group, having access to “Feel the ViBe” and usual care (UC), and a control group, having access to minimally enhanced usual care (mEUC) followed by access to the intervention after twelve weeks. Outcomes are measured with questionnaires on PTSD symptoms, mental health and sexual and reproductive health. Routine Outcome Measurement (ROM) will be used to measure a direct effect of participating in the intervention. Data from a web evaluation questionnaire (WEQ), user statistics and qualitative analysis of online data will be used to support the findings. To compare results Cohen’s d effect sizes will be used. Discussion A RCT and process evaluation will test effectiveness and provide information of how the effects can be explained, how the intervention meets the expectation of participants

Cognitive behavioral therapy for adults with attention-deficit hyperactivity disorder: study protocol for a randomized controlled trial.

PubMed

Huang, Fang; Qian, Qiujin; Wang, Yufeng

2015-04-14

Attention-deficit hyperactivity disorder (ADHD) is a mental disorder beginning in childhood, and about half of patients have symptoms lasting into adulthood. Adult ADHD causes various impairments of emotional, self-esteem, and executive function and life quality aspects. Furthermore, adverse outcomes include academic and occupational failures, traffic accidents and substance abuse, which would be a family and social burden. A combination of medication and psychotherapy is recommended as the treatment for adult ADHD, and cognitive behavioral therapy (CBT) has been validated mostly with evidence-based researches. However, there has been a lack of randomized controlled trials of CBT for patients in China. Moreover, booster sessions of CBT for other disorders have proven effective in reducing recurrence and improving long-term outcomes, which has not been investigated for adult ADHD. This study will testify to the effect of CBT and explore the efficacy of subsequent booster sessions on adult ADHD. It is a three-armed randomized controlled trial to evaluate the efficacy of 12 weeks of CBT based on the published and validated manual and its booster sessions. The 12 weeks of CBT will be conducted weekly and will end at the 12th week, and then the booster sessions will be conducted monthly and end at the 24th week. There are three randomized groups, including a CBT with booster sessions group, a CBT group and a waiting group. Participants are outpatients of the Peking University Sixth Hospital who are diagnosed as having adult ADHD. The Primary efficacy endpoints are the scores of ADHD core symptoms at 12 and 24 weeks. Secondary endpoints include emotion, executive function, self-esteem, life quality and functional magnetic resonance imaging (fMRI) data at different time points, and the change within every group will also be analyzed. This is the first study to explore the efficacy of booster sessions of CBT in adult ADHD as far as we know. The results might increase proof

Risk-Benefit Analysis of Pediatric-Inspired Versus Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicin, and Dexamethasone Protocols for Acute Lymphoblastic Leukemia in Adolescents and Young Adults.

PubMed

Guzauskas, Gregory F; Villa, Kathleen F; Vanhove, Geertrui F; Fisher, Vicki L; Veenstra, David L

2017-03-01

To estimate the risk-benefit trade-off of a pediatric-inspired regimen versus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (hyper-CVAD) for first-line treatment of adolescents/young adult (AYA; ages 16-39 years) patients with Philadelphia-negative acute lymphoblastic leukemia. Patient outcomes were simulated using a 6-state Markov model, including complete response (CR), no CR, first relapse, second CR, second relapse, and death. A Weibull distribution was fit to the progression-free survival curve of hyper-CVAD-treated AYA patients from a single-center study, and comparable patient data from a retrospective study of pediatric regimen-treated AYA patients were utilized to estimate a relative progression difference (hazard ratio = 0.51) and model survival differences. Health-state utilities were estimated based on treatment stage, with an assumption that the pediatric protocol had 0.10 disutility compared with hyper-CVAD before the maintenance phase of treatment. Total life-years and quality-adjusted life-years (QALYs) were compared between treatment protocols at 1, 5, and 10 years, with additional probabilistic sensitivity analyses. Treatment with the pediatric-inspired protocol was associated with a 0.04 increase in life-years, but a 0.01 decrease in QALYs at 1 year. By years 5 and 10, the pediatric-inspired protocol resulted in 0.18 and 0.24 increase in life-years and 0.25 and 0.32 increase in QALYs, respectively, relative to hyper-CVAD. The lower quality of life associated with the induction and intensification phases of pediatric treatment was offset by more favorable progression-free survival and overall survival relative to hyper-CVAD. Our exploratory analysis suggests that, compared with hyper-CVAD, pediatric-inspired protocols may increase life-years throughout treatment stages and QALYs in the long term.

Adoption of pediatric-inspired acute lymphoblastic leukemia regimens by adult oncologists treating adolescents and young adults: A population-based study.

PubMed

Muffly, Lori; Lichtensztajn, Daphne; Shiraz, Parveen; Abrahão, Renata; McNeer, Jennifer; Stock, Wendy; Keegan, Theresa; Gomez, Scarlett Lin

2017-01-01

Studies have demonstrated superior outcomes for adolescent and young adult (AYA) patients with acute lymphoblastic leukemia (ALL) who are treated using pediatric versus adult therapeutic regimens. To the best of our knowledge, whether adult oncologists in the United States have adopted this approach to ALL in AYA patients is currently unknown. The objective of the current study was to provide a population-based description of ALL treatment patterns in AYA individuals over the past decade. Data regarding AYA patients aged 15 to 39 years and diagnosed with ALL between 2004 and 2014 while living in the Greater Bay Area were obtained from the Greater Bay Area Cancer Registry (GBACR). Treating facilities were designated as pediatric or adult centers; induction treatment regimens were abstracted from registry text data fields. Of 304 patients diagnosed in the GBACR catchment region, complete treatment data were available for 229 (75%). The location of care was identified for 296 patients (97%) treated at 31 unique centers. Approximately 70% of AYA patients received induction therapy at an adult treatment center. All AYA patients who were treated at pediatric centers received pediatric ALL regimens. Among AYA patients treated by adult oncologists with complete treatment data, none received a pediatric regimen before 2008. Between 2008 and 2012, while the US Adult Intergroup C10403 pediatric-inspired ALL protocol was open to accrual, 31% of AYA patients treated by adult oncologists received pediatric regimens. This rate fell to 21% from 2013 through 2014. Adult facilities treating ≥ 2 AYA patients with ALL per year captured in the GBACR were more likely to administer pediatric regimens than lower volume centers (P = .03). As of 2014, only a minority of AYA patients with ALL received pediatric ALL regimens at adult cancer centers. Cancer 2017;122-130. © 2016 American Cancer Society. © 2016 American Cancer Society.

Developmentally adapted cognitive processing therapy for adolescents and young adults with PTSD symptoms after physical and sexual abuse: study protocol for a randomized controlled trial.

PubMed

Rosner, Rita; König, Hans-Helmut; Neuner, Frank; Schmidt, Ulrike; Steil, Regina

2014-05-29

Although childhood sexual and/or physical abuse (CSA/CPA) is known to have severe psychopathological consequences, there is little evidence on psychotherapeutic interventions for adolescents and young adults suffering from post-traumatic stress disorder (PTSD). Equally sparse are data on moderators of treatment response on PTSD-related epigenetic changes, health care costs and loss of productivity, alterations in cognitive processing, and on how successful interventions affect all of these factors. Early treatment may prevent later (co)morbidity. In this paper, we present a study protocol for the evaluation of a newly developed psychotherapeutic manual for PTSD after CSA/CPA in adolescents and young adults - the Developmentally Adapted Cognitive Processing Therapy (D-CPT). In a multicenter randomized controlled trial (RCT) D-CPT is compared to treatment as usual (TAU). A sample of 90 adolescent outpatients aged 14 to 21 years will be randomized to one of these conditions. Four assessments will be carried out at baseline, at end of treatment, and 3 and 6 months after end of therapy. Each time, patients will be assessed via clinical interviews and a wide range of questionnaires. In addition to PTSD symptoms and comorbidities, we will evaluate moderators of treatment response, epigenetic profiles, direct and indirect costs of this disorder, and neurophysiological processing of threat cues in PTSD and their respective changes in the course of these two treatments (D-CPT and TAU). The study will provide new insights in the understudied field of PTSD in adolescents and young adults. A newly developed intervention will be evaluated in this therapeutically underserved population. Results will provide data on treatment efficacy, direct and indirect treatment costs, as well as on associations of treatment outcome and PTSD intensity both to epigenetic profiles and to the neurobiological processing of threat cues. Besides, they will help to learn more about the psychopathology

Validation of the Samsung SBM-100A and Microlife BP 3BU1-5 wrist blood pressure measuring devices in adults according to the International Protocol.

PubMed

Altunkan, Sekip; Ilman, Nevzat; Altunkan, Erkan

2007-04-01

A variety of automatic blood measurement devices with diverse features have been introduced to the medical markets recently. Among these devices, models that measure at the wrist have become increasingly popular in self measurements. The objective of this study was to evaluate the accuracy of the Samsung SBM-100A and Microlife BP 3BU1-5 wrist blood pressure devices against the mercury sphygmomanometer in adults according to the International Protocol criteria. Fifty-four patients over 30 years of age were studied and classified based on the International Protocol range. Blood pressure measurements at the wrist with the Samsung SBM-100A and Microlife BP 3BU1-5 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. A total of 33 participants with randomly distributed arm circumferences were selected for both of the validation studies. During each validation study, 99 measurements were obtained for comparison from 33 participants. The first phase was performed on 15 participants and if the device passed this phase, 18 more participants were selected. Mean discrepancies and standard deviations of the device-sphygmomanometer were 0.9+/-9.2 and -2.7+/-9.3 mmHg for systolic blood pressure and -1.4+/-8.0 mmHg and 1.4+/-5.7 for diastolic blood pressure in the Samsung and Microlife study groups, respectively. The Samsung SBM-100A passed Phase 1 in 15 participants. Despite the fact that Microlife BP 3BU1-5 passed Phase 1 for diastolic pressure, it failed according to the systolic pressure criteria. Eighteen patients were added and Phase 2 was continued, in which Samsung SBM-100A failed to meet the criteria of Phases 2.1 and 2.2 for adults in systolic and diastolic blood pressure. It was found that the Microlife BP 3BU1-5 does not meet the criteria of either of Phases 2.1 and 2.2 for systolic blood pressure and Phase 2.2 for diastolic blood pressure. In this study, Samsung SBM

Schema therapy as treatment for adults with autism spectrum disorder and comorbid personality disorder: Protocol of a multiple-baseline case series study testing cognitive-behavioral and experiential interventions.

PubMed

Vuijk, Richard; Arntz, Arnoud

2017-03-01

To our knowledge treatment of personality disorder (PD) comorbidity in adults with ASD is understudied and is still in its infancy. This study investigates the effectiveness of schema therapy for PD-psychopathology in adult patients with both ASD and PD. Twelve adult individuals (age > 18 years) with ASD and at least one PD are given a treatment protocol consisting of 30 weekly offered sessions. A concurrent multiple baseline design is used with baseline varying from 4 to 9 weeks, after which weekly supportive sessions varying from 1 to 6 weeks start with the study therapist. After baseline and 1 to 6 supportive sessions, a 5-week exploration phase follows with weekly sessions during which current and past functioning, psychological symptoms, and schema modes are explored, and information about the treatment is given. This is followed by 15 weekly sessions with cognitive-behavioral interventions and 15 weekly sessions with experiential interventions: patients are vice versa and randomly assigned to the interventions. Finally, there is a 10-month follow-up phase with monthly booster sessions. Participants are randomly assigned to baseline length, and report weekly during treatment and monthly at follow-up on Belief Strength of negative core beliefs, and fill out SMI, SCL-90 and SRS-A 7 times during screening procedure (i.e. before baseline), after supportive sessions, after exploration, after cognitive and behavioral interventions, after experiential interventions, and after 5- and 10- month follow-up. The SCID-II is administered during screening procedure, at 5- and at 10-month follow-up. The Netherlands National Trial Register NTR5788. Registered 01 April 2016.

Improving physical functional and quality of life in older adults with multiple sclerosis via a DVD-delivered exercise intervention: a study protocol.

PubMed

Wójcicki, Thomas R; Roberts, Sarah A; Learmonth, Yvonne C; Hubbard, Elizabeth A; Kinnett-Hopkins, Dominque; Motl, Robert W; McAuley, Edward

2014-12-01

There is a need to identify innovative, low-cost and broad-reaching strategies for promoting exercise and improving physical function in older adults with multiple sclerosis (MS). This randomised controlled pilot trial will test the efficacy of a 6-month, DVD-delivered exercise intervention to improve functional performance and quality of life in older adults with MS. Participants will be randomised either into a DVD-delivered exercise condition or an attentional control condition. This novel approach to programme delivery provides participants with detailed exercise instructions which are presented in a progressive manner and includes a variety of modifications to better meet varying levels of physical abilities. The targeted exercises focus on three critical elements of functional fitness: flexibility, strength and balance. It is hypothesised that participants who are randomised to the exercise DVD condition will demonstrate improvements in physical function compared with participants assigned to the attentional control condition. Data analysis will include a 2 (condition)×2 (time) mixed factor analysis of variance (ANOVA) that follows intent-to-treat principles, as well as an examination of effect sizes. Participants will take part in qualitative interviews about perspectives on physical activity and programme participation. The study protocol was approved by a university institutional review board and registered with a federal database. Participants will be asked to read and sign a detailed informed consent document and will be required to provide a physician's approval to participate in the study. The exercise DVDs include an overview of safety-related concerns and recommendations relative to exercise participation, as well as detailed instructions highlighting the proper execution of each exercise presented on screen. Following completion of this trial, data will be immediately analysed and results will be presented at scientific meetings and published in

Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial.

PubMed

Emmett, Christopher; Close, Helen; Mason, James; Taheri, Shiva; Stevens, Natasha; Eldridge, Sandra; Norton, Christine; Knowles, Charles; Yiannakou, Yan

2017-03-31

Constipation is common in adults and up to 20% of the population report this symptom. Chronic constipation (CC), usually defined as more than 6 months of symptoms, is less common but results in 0.5 million UK GP consultations per annum. The effect of symptoms on measured quality of life (QOL) is significant, and CC consumes significant health care resources. In the UK, it is estimated that 10% of district nursing time is spent on constipation. Trans-anal irrigation therapy has become a widely used treatment despite a lack of robust efficacy data to support its use. The long-term outcome of treatment is also unclear. A randomised comparison of two different methods of irrigation (high- and low-volume) will provide valuable evidence of superiority of one system over the other, as well as providing efficacy data for the treatment as a whole. Participants will be recruited based on predetermined eligibility criteria. Following informed consent, they will be randomised to either high-volume (HV) or low-volume (LV) irrigation and undergo standardised radiological and physiological investigations. Following training, they will commence home irrigation with the allocated device. Data will be collected at 1, 3, 6 and 12 months according to a standardised outcomes framework. The primary outcome is PAC-QOL, measured at 3 months. The study is powered to detect a 10% difference in outcome between systems at 3 months; this means that 300 patients will need to be recruited. This study will be the first randomised comparison of two different methods of trans-anal irrigation. It will also be the largest prospective study of CC patients treated with irrigation. It will provide evidence for the effectiveness of irrigation in the treatment of CC, as well as the comparative effectiveness of the two methods. This will enable more cost-effective and evidence-based use of irrigation. Also, the results will be combined with the other studies in the CapaCiTY programme to generate an

Abdominal stab wound protocol: prospective study documents applicability for widespread use.

PubMed

Rosemurgy, A S; Albrink, M H; Olson, S M; Sherman, H; Albertini, J; Kramer, R; Camps, M; Reiss, A

1995-02-01

Traditionally, stab wounds violating the abdominal wall fascia led to exploratory celiotomy that was often nontherapeutic. In an attempt to limit the number of nontherapeutic celiotomies (NTC), we devised a protocol to prospectively study stab wounds violating the anterior abdominal wall fascia. Through protocol, abdominal stab wounds were explored in stable adults. If the anterior fascia was violated, paracentesis and, if necessary, peritoneal lavage was undertaken in the absence of previous abdominal surgery. If evisceration was noted, it was reduced and the patient lavaged. Fascial penetration was noted in 72 patients. 46 patients underwent celiotomy: because of shock/peritonitis in 8 (2 NTC), fascial penetration with a history of previous celiotomy in 7 (5 NTC), positive paracentesis in 20 (5 NTC), or positive lavage in 10 (4 NTC). One patient underwent late celiotomy without ill-effect after a negative lavage because she subsequently developed fever and localized peritonitis (ice pick injury to cecum). Eleven patients had evisceration; nine underwent celiotomy. Patients with abdominal stab wounds can be selectively managed safely. More than one-third with fascial penetration, some with evisceration, avoided exploration. Only one patient underwent delayed celiotomy and did so without detriment. Nontherapeutic celiotomy rates were highest in patients with previous abdominal surgery who, thereby, could not undergo paracentesis/lavage; excluding these patients, the nontherapeutic celiotomy rate was 17% (11/65) for those with fascial penetration.

A Study of Shared-Memory Mutual Exclusion Protocols Using CADP

NASA Astrophysics Data System (ADS)

Mateescu, Radu; Serwe, Wendelin

Mutual exclusion protocols are an essential building block of concurrent systems: indeed, such a protocol is required whenever a shared resource has to be protected against concurrent non-atomic accesses. Hence, many variants of mutual exclusion protocols exist in the shared-memory setting, such as Peterson's or Dekker's well-known protocols. Although the functional correctness of these protocols has been studied extensively, relatively little attention has been paid to their non-functional aspects, such as their performance in the long run. In this paper, we report on experiments with the performance evaluation of mutual exclusion protocols using Interactive Markov Chains. Steady-state analysis provides an additional criterion for comparing protocols, which complements the verification of their functional properties. We also carefully re-examined the functional properties, whose accurate formulation as temporal logic formulas in the action-based setting turns out to be quite involved.

A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial.

PubMed

Gschwind, Yves J; Kressig, Reto W; Lacroix, Andre; Muehlbauer, Thomas; Pfenninger, Barbara; Granacher, Urs

2013-10-09

With increasing age neuromuscular deficits (e.g., sarcopenia) may result in impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk factors are age-related decreases in balance and strength / power performance as well as cognitive decline. Additional studies are needed to develop specifically tailored exercise programs for older adults that can easily be implemented into clinical practice. Thus, the objective of the present trial is to assess the effects of a fall prevention program that was developed by an interdisciplinary expert panel on measures of balance, strength / power, body composition, cognition, psychosocial well-being, and falls self-efficacy in healthy older adults. Additionally, the time-related effects of detraining are tested. Healthy old people (n = 54) between the age of 65 to 80 years will participate in this trial. The testing protocol comprises tests for the assessment of static / dynamic steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis), proactive balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance (i.e., perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand grip strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test; countermovement jump). Further, body composition will be analysed using a bioelectrical impedance analysis system. In addition, questionnaires for the assessment of psychosocial (i.e., World Health Organisation Quality of Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall risk determinants (i.e., Fall Efficacy Scale - International) will be included in the study protocol. Participants will be randomized into two intervention groups or the control / waiting group. After baseline measures, participants in the intervention groups will conduct a 12-week balance and strength / power exercise intervention 3 times per week, with each training session lasting 30 min

A Peer-Led Electronic Mental Health Recovery App in an Adult Mental Health Service: Study Protocol for a Pilot Trial.

PubMed

Gulliver, Amelia; Banfield, Michelle; Reynolds, Julia; Miller, Sarah; Galati, Connie; Morse, Alyssa R

2017-12-07

There is growing demand for peer workers (people who use their own lived experience to support others in their recovery) to work alongside consumers to improve outcomes and recovery. Augmenting the workforce with peer workers has strong capacity to enhance mental health and recovery outcomes and make a positive contribution to the workforce within mental health systems and to the peer workers themselves. Technology-based applications are highly engaging and desirable methods of service delivery. This project is an exploratory proof-of-concept study, which aims to determine if a peer worker-led electronic mental (e-mental) health recovery program is a feasible, acceptable, and effective adjunct to usual treatment for people with moderate to severe mental illness. The study design comprises a recovery app intervention delivered by a peer worker to individual consumers at an adult mental health service. Evaluation measures will be conducted at post-intervention. To further inform the acceptability and feasibility of the model, consumers will be invited to participate in a focus group to discuss the program. The peer worker, peer supervisor, and key staff at the mental health service will also be individually interviewed to further evaluate the feasibility of the program within the health service and further inform its future development. The program will be delivered over a period of approximately 4 months, commencing June 2017. If the peer worker-led recovery app is found to be feasible, acceptable, and effective, it could be used to improve recovery in mental health service consumers. ©Amelia Gulliver, Michelle Banfield, Julia Reynolds, Sarah Miller, Connie Galati, Alyssa R Morse. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.12.2017.

Effectiveness of aerobic exercise for adults living with HIV: systematic review and meta-analysis using the Cochrane Collaboration protocol.

PubMed

O'Brien, Kelly K; Tynan, Anne-Marie; Nixon, Stephanie A; Glazier, Richard H

2016-04-26

People with HIV are living longer with the health-related consequences of HIV, multi-morbidity, and aging. Exercise is a key strategy that may improve or sustain health for people living with HIV. Our aim was to examine the safety and effectiveness of aerobic exercise interventions on immunological, virological, cardiorespiratory, strength, weight, body composition, and psychological outcomes in adults living with HIV. We conducted a systematic review using the Cochrane Collaboration protocol. We searched databases up to April 2013. We included randomized controlled trials comparing aerobic exercise with no exercise or another intervention performed at least three times per week for at least four weeks among adults living with HIV. Two reviewers independently determined study eligibility. Data were extracted from studies that met inclusion criteria using standardized forms. We assessed risk of bias using the Cochrane Collaboration's tool for assessing risk of bias. Outcomes were analyzed as continuous and meta-analyses conducted using random effects models with Review Manager (RevMan) computer software. Twenty-four studies met inclusion criteria (n = 936 participants at study completion); the majority of participants were men (73 %) and the majority were taking antiretroviral therapy (19/24 included studies). The exercise intervention included aerobic exercise alone (11 studies) or a combination of aerobic and resistive exercise (13 studies) ranging from 5 to 52 weeks. Fifty-eight meta-analyses were performed. Main results indicated statistically significant improvements in selected outcomes of cardiorespiratory status (maximum oxygen consumption, exercise time), strength (chest press, knee flexion), body composition (lean body mass, percent body fat, leg muscle area), depression symptoms, and quality of life (SF-36 questionnaire) among exercisers compared with non-exercisers. No significant differences in change in CD4 count and viral load were found

The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial.

PubMed

Fleming, Jennifer; Ownsworth, Tamara; Doig, Emmah; Hutton, Lauren; Griffin, Janelle; Kendall, Melissa; Shum, David H K

2017-01-05

Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily life. Metacognitive skills training (MST) is a cognitive rehabilitation approach that aims to facilitate the development of self-awareness in adults with TBI. This paper describes the protocol of a study that aims to evaluate the efficacy of a MST approach to compensatory PM rehabilitation for improving everyday PM performance and psychosocial outcomes after TBI. This randomized controlled trial has three treatment groups: compensatory training plus metacognitive skills training (COMP-MST), compensatory training only (COMP), and waitlist control. Participants in the COMP-MST and COMP groups will complete a 6-week intervention consisting of six 2-h weekly training sessions. Each 1.5-h session will involve compensatory strategy training and 0.5 h will incorporate either MST (COMP-MST group) or filler activity as an active control (COMP group). Participants in the waitlist group receive care as usual for 6 weeks, followed by the COMP-MST intervention. Based on the sample size estimate, 90 participants with moderate to severe TBI will be randomized into the three groups using a stratified sampling approach. The primary outcomes include measures of PM performance in everyday life and level of psychosocial reintegration. Secondary outcomes include measures of PM function on psychometric testing, strategy use, self-awareness, and level of support needs following TBI. Blinded assessments will be conducted pre and post intervention, and at 3-month and 6-month follow-ups. This study seeks to determine the efficacy of COMP-MST for improving and maintaining everyday PM performance and level of psychosocial

Clinical review of 24-35 year olds conceived with and without in vitro fertilization: study protocol.

PubMed

Lewis, Sharon; Kennedy, Joanne; Burgner, David; McLachlan, Robert; Ranganathan, Sarath; Hammarberg, Karin; Saffery, Richard; Amor, David J; Cheung, Michael M H; Doyle, Lex W; Juonala, Markus; Donath, Susan; McBain, John; Halliday, Jane

2017-09-20

Children conceived by assisted reproductive technologies (ART) currently comprise 4% of Australian births. The manipulation of biological parameters related to fertilization and implantation are integral to successful ART but potentially pose a risk to the longer-term health of the offspring. There is consensus that many common adult health problems (particularly cardiovascular, metabolic and respiratory conditions) have their origins in early life, possibly before birth, and that risk trajectories track through childhood until clinical disease manifests in adulthood. Early life epigenetic variation may play a role in this process. However little is known about the long-term health of individuals conceived by ART. In a previous study, based on telephone-interviews, we found that young adults conceived by in vitro fertilization (IVF) had significantly more maternal reported atopic respiratory, endocrine, nutritional, and metabolic conditions than non-IVF conceived matched controls. Here we outline the protocol for a follow-up biomedical assessment of this cohort and a questionnaire to obtain information on potential confounders. We are conducting a clinical review of an existing, well characterised cohort comprising 547 IVF-conceived adults and 549 matched controls. We are measuring cardiovascular intermediate phenotypes, metabolic parameters and respiratory function, complemented by epigenome-wide DNA methylation analysis. A pilot study demonstrated the feasibility of our proposed protocol and its acceptability to participants. Participants attend a 2-3 h clinical assessment and complete a study-specific online questionnaire. Measurements include: 1) cardiovascular phenotypes: carotid artery intima-media thickness and distensibility, retinal vascular calibre, resting blood pressure, pulse wave velocity and pulse wave analysis; 2) respiratory function: spirometry, plethysmography, multiple breath washout; 3) auxology: height, weight, waist circumference, bio

A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer's disease.

PubMed

Green, Robert C; Christensen, Kurt D; Cupples, L Adrienne; Relkin, Norman R; Whitehouse, Peter J; Royal, Charmaine D M; Obisesan, Thomas O; Cook-Deegan, Robert; Linnenbringer, Erin; Butson, Melissa Barber; Fasaye, Grace-Ann; Levinson, Elana; Roberts, J Scott

2015-10-01

Conventional multisession genetic counseling is currently recommended when disclosing apolipoprotein E (APOE) genotype for the risk of Alzheimer's disease (AD) in cognitively normal individuals. The objective of this study was to evaluate the safety of brief disclosure protocols for disclosing APOE genotype for the risk of AD. A randomized, multicenter noninferiority trial was conducted at four sites. Participants were asymptomatic adults having a first-degree relative with AD. A standard disclosure protocol by genetic counselors (SP-GC) was compared with condensed protocols, with disclosures by genetic counselors (CP-GC) and by physicians (CP-MD). Preplanned co-primary outcomes were anxiety and depression scales 12 months after disclosure. Three hundred and forty-three adults (mean age 58.3, range 33-86 years, 71% female, 23% African American) were randomly assigned to the SP-GC protocol (n = 115), CP-GC protocol (n = 116), or CP-MD protocol (n = 112). Mean postdisclosure scores on all outcomes were well below cut-offs for clinical concern across protocols. Comparing CP-GC with SP-GC, the 97.5% upper confidence limits at 12 months after disclosure on co-primary outcomes of anxiety and depression ranged from a difference of 1.2 to 2.0 in means (all P < .001 on noninferiority tests), establishing noninferiority for condensed protocols. Results were similar between European Americans and African Americans. These data support the safety of condensed protocols for APOE disclosure for those free of severe anxiety or depression who are actively seeking such information. Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Moderate glycemic control safe in critically ill adult burn patients: A 15 year cohort study.

PubMed

Stoecklin, Patricia; Delodder, Frederik; Pantet, Olivier; Berger, Mette M

2016-02-01

Hyperglycemia is a metabolic alteration in major burn patients associated with complications. The study aimed at evaluating the safety of general ICU glucose control protocols applied in major burns receiving prolonged ICU treatment. 15 year retrospective analysis of consecutive, adult burn patients admitted to a single specialized centre. death or length of stay <10 days, age <16 years. demographic variables, burned surface (TBSA), severity scores, infections, ICU stay, outcome. Metabolic variables: total energy, carbohydrate and insulin delivery/24h, arterial blood glucose and CRP values. Analysis of 4 periods: 1, before protocol; 2, tight doctor driven; 3, tight nurse driven; 4, moderate nurse driven. 229 patients, aged 45 ± 20 years (mean ± SD), burned 32 ± 20% TBSA were analyzed. SAPSII was 35 ± 13. TBSA, Ryan and ABSI remained stable. Inhalation injury increased. A total of 28,690 blood glucose samples were analyzed: the median value remained unchanged with a narrower distribution over time. After the protocol initiation, the normoglycemic values increased from 34.7% to 65.9%, with a reduction of hypoglycaemic events (no extreme hypoglycemia in period 4). Severe hyperglycemia persisted throughout with a decrease in period 4 (9.25% in period 4). Energy and glucose deliveries decreased in periods 3 and 4 (p<0.0001). Infectious complications increased during the last 2 periods (p=0.01). A standardized ICU glucose control protocol improved the glycemic control in adult burn patients, reducing glucose variability. Moderate glycemic control in burns was safe specifically related to hypoglycemia, reducing the incidence of hypoglycaemic events compared to the period before. Hyperglycemia persisted at a lower level. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

Physical rehabilitation interventions for adult patients with critical illness across the continuum of recovery: an overview of systematic reviews protocol.

PubMed

Connolly, Bronwen; O'Neill, Brenda; Salisbury, Lisa; McDowell, Kathryn; Blackwood, Bronagh

2015-09-29

Patients admitted to the intensive care unit with critical illness often experience significant physical impairments, which typically persist for many years following resolution of the original illness. Physical rehabilitation interventions that enhance restoration of physical function have been evaluated across the continuum of recovery following critical illness including within the intensive care unit, following discharge to the ward and beyond hospital discharge. Multiple systematic reviews have been published appraising the expanding evidence investigating these physical rehabilitation interventions, although there appears to be variability in review methodology and quality. We aim to conduct an overview of existing systematic reviews of physical rehabilitation interventions for adult intensive care patients across the continuum of recovery. This protocol has been developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. We will search the Cochrane Systematic Review Database, Database of Abstracts of Reviews of Effectiveness, Cochrane Central Register of Controlled Trials, MEDLINE, Excerpta Medica Database and Cumulative Index to Nursing and Allied Health Literature databases. We will include systematic reviews of randomised controlled trials of adult patients, admitted to the intensive care unit and who have received physical rehabilitation interventions at any time point during their recovery. Data extraction will include systematic review aims and rationale, study types, populations, interventions, comparators, outcomes and quality appraisal method. Primary outcomes of interest will focus on findings reflecting recovery of physical function. Quality of reporting and methodological quality will be appraised using the PRISMA checklist and the Assessment of Multiple Systematic Reviews tool. We anticipate the findings from this novel overview of systematic reviews will contribute to the

Feasibility of high-intensity interval training and moderate-intensity continuous training in adults with inactive or mildly active Crohn's disease: study protocol for a randomised controlled trial.

PubMed

Tew, Garry A; Carpenter, Roger; Seed, Michael; Anderson, Simon; Langmead, Louise; Fairhurst, Caroline; Bottoms, Lindsay

2017-01-01

Structured exercise training has been proposed as a useful adjunctive therapy for Crohn's disease by improving immune function and psychological health, reducing fatigue and promoting gains in muscle and bone strength. However, the evidence for exercise in Crohn's disease is sparse, with only a handful of small prospective trials [1, 2], with methodological limitations, including the use of non-randomised and non-controlled study designs and small sample sizes. Here, we describe the protocol for a study that aims to assess the feasibility and acceptability of two common types of exercise training-high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT)-in adults with inactive or mildly active Crohn's disease (CD). This is a randomised, controlled, assessor-blinded, feasibility trial with three parallel groups. Forty-five adults with inactive or mildly active Crohn's disease will be randomly assigned 1:1:1 to HIIT, MICT or usual care control. Participants in the HIIT and MICT groups will be invited to undertake three sessions of supervised exercise each week for 12 consecutive weeks. HIIT sessions will consist of ten 1-min intervals of cycling exercise at 90% of peak power output separated by 1 min of active recovery. MICT sessions will involve 30 min of continuous cycling at 35% of peak power output. Participants will be assessed before randomisation and 13 and 26 weeks after randomisation. Feasibility outcomes include rates of recruitment, retention and adherence. Interviews with participants will explore the acceptability of the exercise programmes and study procedures. Clinical/health outcomes include cardiorespiratory fitness, body mass index, resting blood pressure, markers of disease activity (faecal calprotectin and Crohn's Disease Activity Index) and activated T cell cytokine profiles. Study questionnaires include the Inflammatory Bowel Disease Quality of Life Questionnaire, EQ-5D-5L, IBD Fatigue Scale, Hospital and

28 CFR 115.321 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... allegations of sexual abuse, the agency shall follow a uniform evidence protocol that maximizes the potential... or otherwise based on the most recent edition of the U.S. Department of Justice's Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic Examinations, Adults...

28 CFR 115.321 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... allegations of sexual abuse, the agency shall follow a uniform evidence protocol that maximizes the potential... or otherwise based on the most recent edition of the U.S. Department of Justice's Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic Examinations, Adults...

28 CFR 115.321 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... allegations of sexual abuse, the agency shall follow a uniform evidence protocol that maximizes the potential... or otherwise based on the most recent edition of the U.S. Department of Justice's Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic Examinations, Adults...

Goal-setting protocol in adherence to exercise by Italian adults.

PubMed

Annesi, James J

2002-04-01

A goal-setting protocol, based on research in goal setting and performance and personal construct theory, was tested for its effect on adherence to a new exercise program. The Goal-setting group (n = 50) had significantly less dropout (30%) than the control group (n = 50) (74%). The Goal-setting group also had significantly better attendance (p<.0001). Suggestions for increasing confidence in findings through further research and practical implications of using the protocol to improve exercise maintenance across settings were discussed.

Vestibular rehabilitation using video gaming in adults with dizziness: a pilot study.

PubMed

Phillips, J S; Fitzgerald, J; Phillis, D; Underwood, A; Nunney, I; Bath, A

2018-03-01

To determine the effectiveness of vestibular rehabilitation using the Wii Fit balance platform, in adults with dizziness. A single-site prospective clinical trial was conducted in a university hospital in the UK. Forty patients with dizziness, who would normally be candidates for vestibular rehabilitation, were identified and considered as potential participants. Participants were randomised into either the treatment group (the Wii Fit group) or the control group (standard customised vestibular rehabilitation protocol). Participants were assessed over a 16-week period using several balance and quality of life questionnaires. Both exercise regimes resulted in a reduction of dizziness and an improvement in quality of life scores over time, but no statistically significant difference between the two interventions was identified. This pilot study demonstrated that use of the Wii Fit balance platform resulted in a statistically significant improvement in balance function and quality of life. Furthermore, outcomes were comparable to a similar group of individuals following a standard customised vestibular rehabilitation protocol. The study provides useful information to inform the design and execution of a larger clinical trial.

A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT)

PubMed Central

Lall, Ranjit; Withers, Emma J; Finnegan, Susanne; Underwood, Martin; Hulme, Claire; Sheridan, Ray; Skelton, Dawn A; Martin, Finbarr; Lamb, Sarah E

2016-01-01

Introduction Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. Methods and analysis A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver ‘active’ interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to ‘active’ intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. Ethics and dissemination The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention

A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT).

PubMed

Bruce, Julie; Lall, Ranjit; Withers, Emma J; Finnegan, Susanne; Underwood, Martin; Hulme, Claire; Sheridan, Ray; Skelton, Dawn A; Martin, Finbarr; Lamb, Sarah E

2016-01-18

Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver 'active' interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to 'active' intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the

A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background With increasing age neuromuscular deficits (e.g., sarcopenia) may result in impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk factors are age-related decreases in balance and strength / power performance as well as cognitive decline. Additional studies are needed to develop specifically tailored exercise programs for older adults that can easily be implemented into clinical practice. Thus, the objective of the present trial is to assess the effects of a fall prevention program that was developed by an interdisciplinary expert panel on measures of balance, strength / power, body composition, cognition, psychosocial well-being, and falls self-efficacy in healthy older adults. Additionally, the time-related effects of detraining are tested. Methods/Design Healthy old people (n = 54) between the age of 65 to 80 years will participate in this trial. The testing protocol comprises tests for the assessment of static / dynamic steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis), proactive balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance (i.e., perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand grip strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test; countermovement jump). Further, body composition will be analysed using a bioelectrical impedance analysis system. In addition, questionnaires for the assessment of psychosocial (i.e., World Health Organisation Quality of Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall risk determinants (i.e., Fall Efficacy Scale – International) will be included in the study protocol. Participants will be randomized into two intervention groups or the control / waiting group. After baseline measures, participants in the intervention groups will conduct a 12-week balance and strength / power exercise intervention 3 times per week, with

Needs and Achievements of the Juvenile Justice System: Insights From Two Empirical Studies With Portuguese Young Adults.

PubMed

Basto-Pereira, Miguel; Ribeiro, Sofia; Maia, Ângela

2018-05-01

Over the last decade, studies have evaluated the effectiveness of interventions for juvenile offenders; nonetheless, those studies were more focused on recidivism than on the mechanisms associated with criminal perpetration. The current study explores the role of juvenile justice involvement and detention measures in a set of psychological, social, and criminal behavior characteristics in early adulthood. Seventy-five young adults with official records of juvenile delinquency in 2010-2011 and 240 young adults from the community filled out our protocol in 2014-2015. Young adults with juvenile justice involvement showed worse psychological, social, and criminal outcomes than those from community. Detention appears to be related to the number of deviant friends, delinquency, and school achievement in early adulthood. Our findings are in line with the labeling and deviant peer contagion theories and establish the main areas of interventions that affect the identified needs. A set of policy implications is provided.

An in silico method to identify computer-based protocols worthy of clinical study: An insulin infusion protocol use case

PubMed Central

Wong, Anthony F; Pielmeier, Ulrike; Haug, Peter J; Andreassen, Steen

2016-01-01

Objective Develop an efficient non-clinical method for identifying promising computer-based protocols for clinical study. An in silico comparison can provide information that informs the decision to proceed to a clinical trial. The authors compared two existing computer-based insulin infusion protocols: eProtocol-insulin from Utah, USA, and Glucosafe from Denmark. Materials and Methods The authors used eProtocol-insulin to manage intensive care unit (ICU) hyperglycemia with intravenous (IV) insulin from 2004 to 2010. Recommendations accepted by the bedside clinicians directly link the subsequent blood glucose values to eProtocol-insulin recommendations and provide a unique clinical database. The authors retrospectively compared in silico 18 984 eProtocol-insulin continuous IV insulin infusion rate recommendations from 408 ICU patients with those of Glucosafe, the candidate computer-based protocol. The subsequent blood glucose measurement value (low, on target, high) was used to identify if the insulin recommendation was too high, on target, or too low. Results Glucosafe consistently provided more favorable continuous IV insulin infusion rate recommendations than eProtocol-insulin for on target (64% of comparisons), low (80% of comparisons), or high (70% of comparisons) blood glucose. Aggregated eProtocol-insulin and Glucosafe continuous IV insulin infusion rates were clinically similar though statistically significantly different (Wilcoxon signed rank test P = .01). In contrast, when stratified by low, on target, or high subsequent blood glucose measurement, insulin infusion rates from eProtocol-insulin and Glucosafe were statistically significantly different (Wilcoxon signed rank test, P < .001), and clinically different. Discussion This in silico comparison appears to be an efficient nonclinical method for identifying promising computer-based protocols. Conclusion Preclinical in silico comparison analytical framework allows rapid and inexpensive

Comparative study of 2 oral care protocols in intensive care units.

PubMed

Ory, Jérôme; Raybaud, Evelyne; Chabanne, Russell; Cosserant, Bernard; Faure, Jean Sébastien; Guérin, Renaud; Calvet, Laure; Pereira, Bruno; Mourgues, Charline; Guelon, Dominique; Traore, Ousmane

2017-03-01

The quality of oral care is important in limiting the emergence of ventilator-associated pneumonia (VAP) in intubated patients. Our main objective was to measure the quality improvement in oral care following the implementation of a new oral care protocol. We also monitored VAP rates. This was a cohort study of patients in 5 adult ICUs covering different specialties. During period 1, caregivers used a foam stick for oral care and during period 2 a stick and tooth brushing with aspiration. Oral chlorhexidine was used during both periods. The caregivers rated improvement in oral health on the basis of 4 criteria (tongue, mucous membranes, gingivae, and teeth). Caregiver satisfaction was also assessed. The incidence of VAP was monitored. A total of 2,030 intubated patients admitted to intensive care units benefited from oral care. The patient populations during the 2 periods were similar with regard to demographic data and VAP potential risk factors. Oral health was significantly better from the third day of oral care in period 2 onward (period 1, 6.4 ± 2.1; period 2, 5.6 ± 1.8; P = .043). Caregivers found the period 2 protocol easier to implement and more effective. VAP rates decreased significantly between the 2 periods (period 1, 12.8%; period 2, 8.5%; P = .002). Our study showed that the implementation of a simple strategy improved the quality of oral care of patients in intensive care units, and decreased VAP rates. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Exploring end-of-life interaction in dyads of parents and adult children: a protocol for a mixed-methods study.

PubMed

Stiel, Stephanie; Stelzer, Eva-Maria; Schneider, Nils; Herbst, Franziska A

2018-04-27

A considerable number of terminally-ill adult children are outlived by at least one parent and receive palliative care prior to their death. At the same time, adult children continue to be confronted with their parents' terminal illnesses and end-of-life situations. The current study explores the specifics of dyadic interaction at the end of life between a) adult children suffering from a life-threatening disease and their parents, and b) terminally ill parents and their adult children. This prospective observational study aims at filling the existing gap on adult child-parent interaction specifics at the end of life using an exploratory mixed-methods framework. The mixed-methods framework combines a qualitative face-to face interview and quantitative self-report questionnaires to study the topic at hand. The qualitative interview will focus on experiences, expectations, and wishes with regard to dyadic communication, information about illness and prognosis, expressed and perceived burden and support as well as caregiving role at the end of life. The questionnaires will cover socio-demographics, loneliness, attachment style, social support, and emotional closeness. The research group is currently adjusting a semi-structured interview guide and questionnaire instructions based on the results of a multiprofessional scientific advisory board meeting (Jan. 2018). In a next step, and prior to qualitative and quantitative data collection, the questionnaires will be piloted on patients and their family members in a palliative care setting. The main expected results are i) a description of the specifics of the interaction within and between both dyads, ii) the development of hypotheses and a theoretical framework on the specifics, similarities, and differences for both study groups, and iii) clinical conclusions on specific psychosocial care needs of both groups. The study was registered prospectively in the Health Services Research Germany register (Versorgungsforschung

Quantitative Comparison of 21 Protocols for Labeling Hippocampal Subfields and Parahippocampal Subregions in In Vivo MRI: Towards a Harmonized Segmentation Protocol

PubMed Central

Yushkevich, Paul A.; Amaral, Robert S. C.; Augustinack, Jean C.; Bender, Andrew R.; Bernstein, Jeffrey D.; Boccardi, Marina; Bocchetta, Martina; Burggren, Alison C.; Carr, Valerie A.; Chakravarty, M. Mallar; Chetelat, Gael; Daugherty, Ana M.; Davachi, Lila; Ding, Song-Lin; Ekstrom, Arne; Geerlings, Mirjam I.; Hassan, Abdul; Huang, Yushan; Iglesias, Eugenio; La Joie, Renaud; Kerchner, Geoffrey A.; LaRocque, Karen F.; Libby, Laura A.; Malykhin, Nikolai; Mueller, Susanne G.; Olsen, Rosanna K.; Palombo, Daniela J.; Parekh, Mansi B; Pluta, John B.; Preston, Alison R.; Pruessner, Jens C.; Ranganath, Charan; Raz, Naftali; Schlichting, Margaret L.; Schoemaker, Dorothee; Singh, Sachi; Stark, Craig E. L.; Suthana, Nanthia; Tompary, Alexa; Turowski, Marta M.; Van Leemput, Koen; Wagner, Anthony D.; Wang, Lei; Winterburn, Julie L.; Wisse, Laura E.M.; Yassa, Michael A.; Zeineh, Michael M.

2015-01-01

OBJECTIVE An increasing number of human in vivo magnetic resonance imaging (MRI) studies have focused on examining the structure and function of the subfields of the hippocampal formation (the dentate gyrus, CA fields 1–3, and the subiculum) and subregions of the parahippocampal gyrus (entorhinal, perirhinal, and parahippocampal cortices). The ability to interpret the results of such studies and to relate them to each other would be improved if a common standard existed for labeling hippocampal subfields and parahippocampal subregions. Currently, research groups label different subsets of structures and use different rules, landmarks, and cues to define their anatomical extents. This paper characterizes, both qualitatively and quantitatively, the variability in the existing manual segmentation protocols for labeling hippocampal and parahippocampal substructures in MRI, with the goal of guiding subsequent work on developing a harmonized substructure segmentation protocol. METHOD MRI scans of a single healthy adult human subject were acquired both at 3 Tesla and 7 Tesla. Representatives from 21 research groups applied their respective manual segmentation protocols to the MRI modalities of their choice. The resulting set of 21 segmentations was analyzed in a common anatomical space to quantify similarity and identify areas of agreement. RESULTS The differences between the 21 protocols include the region within which segmentation is performed, the set of anatomical labels used, and the extents of specific anatomical labels. The greatest overall disagreement among the protocols is at the CA1/subiculum boundary, and disagreement across all structures is greatest in the anterior portion of the hippocampal formation relative to the body and tail. CONCLUSIONS The combined examination of the 21 protocols in the same dataset suggests possible strategies towards developing a harmonized subfield segmentation protocol and facilitates comparison between published studies. PMID

Mobile phone text message intervention to reduce binge drinking among young adults: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Heavy episodic (binge) drinking is common among young adults and can lead to injury and illness. Young adults who seek care in the Emergency Department (ED) may be disproportionately affected with binge drinking behavior, therefore provide an opportunity to reduce future risk through screening, brief intervention and referral to treatment (SBIRT). Mobile phone text messaging (SMS) is a common form of communication among young adults and has been shown to be effective at providing behavioral support to young adult drinkers after ED discharge. Efficacy of SMS programs to reduce binge drinking remains unknown. Methods/Design We will conduct a three parallel arm, randomized trial. A convenience sample of adults aged 18 to 25 years attending three EDs in Pittsburgh, PA and willing to participate in the study will be screened for hazardous alcohol consumption. Participants identified as hazardous drinkers will then be allocated to either 12 weeks of weekly SMS drinking assessments with feedback (SA+F), SMS drinking assessments without feedback (SA), or a control group. Randomization will be via an independent and remote computerized randomization and will be stratified by study site. The SA+F group will be asked to provide pre-weekend drinking intention as well as post-weekend consumption via SMS and will receive feedback messages focused on health consequences of alcohol consumption, personalized normative feedback, protective drinking strategies and goal setting. Follow-up data on alcohol use and injury related to alcohol will be collected through a password-protected website three, six and nine months later. The primary outcome for the study is binge drinking days (≥4 drinks for women; ≥5 drinks for men) during the previous month, and the main secondary outcome is the proportion of participants who report any injury related to alcohol in the prior three months. Discussion This study will test the hypothesis that a mobile phone text-messaging program

Is Acculturation Related to Obesity in Hispanic/Latino Adults? Results from the Hispanic Community Health Study/Study of Latinos

PubMed Central

Isasi, Carmen R.; Ayala, Guadalupe X.; Sotres-Alvarez, Daniela; Penedo, Frank; Loria, Catherine M.; Elder, John P.; Daviglus, Martha L.; Barnhart, Janice; Siega-Riz, Anna Maria; Schneiderman, Neil

2015-01-01

Background. The study examined the association of obesity with acculturation in a large and diverse sample of US Hispanic/Latino adults. Methods. The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL) is a community-based cohort study of Hispanic/Latino adults aged 18–74 years (N = 16,415) from four urban areas. Height and weight were directly measured using a standardized protocol. Acculturation was assessed by the Short Acculturation Scale for Hispanics (SASH). Other immigration related variables included place of birth, length of residency in the US, and age at immigration. Odds ratios were calculated to assess the association of overweight, moderate obesity, and extreme obesity (≥40 kg/m2) with acculturation and sociodemographic variables. Results. The prevalence of obesity was 42.4% for women and 36.5% for men and varied by field center and Hispanic/Latino background. The strongest predictor of moderate and extreme obesity was length of residency in mainland US. This association was consistent across Hispanic/Latino backgrounds. Acculturation was not significantly associated with obesity. Discussion. The burden of obesity is high among Hispanic/Latino adults. The study findings suggest that prolonged exposure to the environments in these communities, rather than acculturation, is an important risk factor for obesity in this population. PMID:25893114

Prevalence of refractive errors in the European adult population: the Gutenberg Health Study (GHS).

PubMed

Wolfram, Christian; Höhn, René; Kottler, Ulrike; Wild, Philipp; Blettner, Maria; Bühren, Jens; Pfeiffer, Norbert; Mirshahi, Alireza

2014-07-01

To study the distribution of refractive errors among adults of European descent. Population-based eye study in Germany with 15010 participants aged 35-74 years. The study participants underwent a detailed ophthalmic examination according to a standardised protocol. Refractive error was determined by an automatic refraction device (Humphrey HARK 599) without cycloplegia. Definitions for the analysis were myopia <-0.5 dioptres (D), hyperopia >+0.5 D, astigmatism >0.5 cylinder D and anisometropia >1.0 D difference in the spherical equivalent between the eyes. Exclusion criterion was previous cataract or refractive surgery. 13959 subjects were eligible. Refractive errors ranged from -21.5 to +13.88 D. Myopia was present in 35.1% of this study sample, hyperopia in 31.8%, astigmatism in 32.3% and anisometropia in 13.5%. The prevalence of myopia decreased, while the prevalence of hyperopia, astigmatism and anisometropia increased with age. 3.5% of the study sample had no refractive correction for their ametropia. Refractive errors affect the majority of the population. The Gutenberg Health Study sample contains more myopes than other study cohorts in adult populations. Our findings do not support the hypothesis of a generally lower prevalence of myopia among adults in Europe as compared with East Asia.

Acupuncture treatment for ischaemic stroke in young adults: protocol for a randomised, sham-controlled clinical trial

PubMed Central

Chen, Lifang; Fang, Jianqiao; Jin, Xiaoming; Keeler, Crystal Lynn; Gao, Hong; Fang, Zhen; Chen, Qin

2016-01-01

Introduction Stroke in young adults is not uncommon. Although the overall incidence of stroke has been recently declining, the incidence of stroke in young adults is increasing. Traditional vascular risk factors are the main cause of young ischaemic stroke. Acupuncture has been shown to benefit stroke rehabilitation and ameliorate the risk factors for stroke. The aims of this study were to determine whether acupuncture treatment will be effective in improving the activities of daily living (ADL), motor function and quality of life (QOL) in patients of young ischaemic stroke, and in preventing stroke recurrence by controlling blood pressure, lipids and body weight. Methods and analysis In this randomised, sham-controlled, participant-blinded and assessor-blinded clinical trial, 120 patients between 18 and 45 years of age with a recent (within 1 month) ischaemic stroke will be randomised for an 8-week acupuncture or sham acupuncture treatment. The primary outcome will be the Barthel Index for ADL. The secondary outcomes will include the Fugl-Meyer Assessment for motor function; the World Health Organization Quality of Life BREF (WHOQOL-BREF) for QOL; and risk factors that are measured by ambulatory blood pressure, the fasting serum lipid, body mass index and waist circumference. Incidence of adverse events and long-term mortality and recurrence rate during a 10-year and 30-year follow-up will also be investigated. Ethics and dissemination Ethics approval was obtained from the Ethics Committee of The Third Affiliated Hospital of Zhejiang Chinese Medical University. Protocol V.3 was approved in June 2013. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone during follow-up calls enquiring on the patient's post-study health status. Trial registration number ChiCTR-TRC- 13003317; Pre-results. PMID:26739742

Long-Term Follow-Up Study of Young Adults Treated for Unilateral Complete Cleft Lip, Alveolus, and Palate by a Treatment Protocol Including Two-Stage Palatoplasty: Speech Outcomes

PubMed Central

Bittermann, Dirk; Janssen, Laura; Bittermann, Gerhard Koendert Pieter; Boonacker, Chantal; Haverkamp, Sarah; de Wilde, Hester; Van Der Heul, Marise; Specken, Tom FJMC; Koole, Ron; Kon, Moshe; Breugem, Corstiaan Cornelis; Mink van der Molen, Aebele Barber

2017-01-01

Background No consensus exists on the optimal treatment protocol for orofacial clefts or the optimal timing of cleft palate closure. This study investigated factors influencing speech outcomes after two-stage palate repair in adults with a non-syndromal complete unilateral cleft lip and palate (UCLP). Methods This was a retrospective analysis of adult patients with a UCLP who underwent two-stage palate closure and were treated at our tertiary cleft centre. Patients ≥17 years of age were invited for a final speech assessment. Their medical history was obtained from their medical files, and speech outcomes were assessed by a speech pathologist during the follow-up consultation. Results Forty-eight patients were included in the analysis, with a mean age of 21 years (standard deviation, 3.4 years). Their mean age at the time of hard and soft palate closure was 3 years and 8.0 months, respectively. In 40% of the patients, a pharyngoplasty was performed. On a 5-point intelligibility scale, 84.4% received a score of 1 or 2; meaning that their speech was intelligible. We observed a significant correlation between intelligibility scores and the incidence of articulation errors (P<0.001). In total, 36% showed mild to moderate hypernasality during the speech assessment, and 11%–17% of the patients exhibited increased nasalance scores, assessed through nasometry. Conclusions The present study describes long-term speech outcomes after two-stage palatoplasty with hard palate closure at a mean age of 3 years old. We observed moderate long-term intelligibility scores, a relatively high incidence of persistent hypernasality, and a high pharyngoplasty incidence. PMID:28573094

Study on Cloud Security Based on Trust Spanning Tree Protocol

NASA Astrophysics Data System (ADS)

Lai, Yingxu; Liu, Zenghui; Pan, Qiuyue; Liu, Jing

2015-09-01

Attacks executed on Spanning Tree Protocol (STP) expose the weakness of link layer protocols and put the higher layers in jeopardy. Although the problems have been studied for many years and various solutions have been proposed, many security issues remain. To enhance the security and credibility of layer-2 network, we propose a trust-based spanning tree protocol aiming at achieving a higher credibility of LAN switch with a simple and lightweight authentication mechanism. If correctly implemented in each trusted switch, the authentication of trust-based STP can guarantee the credibility of topology information that is announced to other switch in the LAN. To verify the enforcement of the trusted protocol, we present a new trust evaluation method of the STP using a specification-based state model. We implement a prototype of trust-based STP to investigate its practicality. Experiment shows that the trusted protocol can achieve security goals and effectively avoid STP attacks with a lower computation overhead and good convergence performance.

Efficacy and External Validity of Electronic and Mobile Phone-Based Interventions Promoting Vegetable Intake in Young Adults: A Systematic Review Protocol.

PubMed

Nour, Monica Marina; Chen, Juliana; Allman-Farinelli, Margaret

2015-07-28

Despite social marketing campaigns and behavior change interventions, young adults remain among the lowest consumers of vegetables. The digital era offers potential new avenues for both social marketing and individually tailored programs, through texting, web, and mobile applications. The effectiveness and generalizability of such programs have not been well documented. The aim of this systematic review is to evaluate the efficacy and external validity of social marketing, electronic, and mobile phone-based (mHealth) interventions aimed at increasing vegetable intake in young adults. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) protocol will be used to conduct this systematic review. The search strategy will be executed across eleven electronic databases using combinations of the following search terms: "online intervention", "computer-assisted therapy", "internet", "website", "cell phones", "cyber", "telemedicine", "email", "social marketing", "social media", "mass media", "young adult", and "fruit and vegetables". The reference lists of included studies will also be searched for additional citations. Titles and abstracts will be screened against inclusion criteria and full texts of potentially eligible papers will be assessed by two independent reviewers. Data from eligible papers will be extracted. Quality and risk of bias will be assessed using the Effective Public Health Practice Project (EPHPP) Quality Assessment Tool for Quantitative Studies and The Cochrane Collaboration Risk of Bias assessment tool respectively. The external validity of the studies will be determined based on components such as reach, adoption, and representativeness of participants; intervention implementation and adaption; and program maintenance and institutionalization. Results will be reported quantitatively and qualitatively. Our research is in progress. A draft of the systematic review is currently being produced for publication by the end of 2015

Effectiveness of alternative listening devices to conventional hearing aids for adults with hearing loss: a systematic review protocol

PubMed Central

Barker, Alex B; Xia, Jun

2016-01-01

Introduction Hearing loss is a major public health concern, affecting over 11 million people in the UK. While hearing aids are the most common clinical intervention for hearing loss, the majority of people that would benefit from using hearing aids do not take them up. Recent technological advances have led to a rapid increase of alternative listening devices to conventional hearing aids. These include hearing aids that can be customised using a smartphone, smartphone-based ‘hearing aid’ apps, personal sound amplification products and wireless hearing products. However, no systematic review has been published evaluating whether alternative listening devices are an effective management strategy for people with hearing loss. Methods and analysis The objective of this systematic review is to assess whether alternative listening devices are an effective intervention for adults with hearing loss. Methods are reported according to the Preferred Reporting Items for Systematic reviews and Meta-analyses Protocols (PRISMA-P) 2015 checklist. Retrospective or prospective studies, randomised controlled trials, non-randomised controlled trials, and before-after comparison studies will be eligible for inclusion. We will include studies with adult participants (≥18 years) with a mild or moderate hearing loss. The intervention should be an alternative listening device to a conventional hearing aid (comparison). Studies will be restricted to outcomes associated with the consequences of hearing loss. We will search relevant databases to identify published, completed but unpublished and ongoing trials. The overall quality of included evidence will be evaluated using the GRADE system, and meta-analysis performed if appropriate. Ethics and dissemination No ethical issues are foreseen. The findings will be reported at national and international conferences, primarily audiology, and ear, nose and throat, and in a peer-reviewed journal using the PRISMA guidelines. Review

Demonstration and Certification of Amphibian Ecological Risk Assessment Protocol. Cost and Performance Report (Version 2)

DTIC Science & Technology

2009-07-01

sediment protocol, respectively). The soil protocol evaluates impacts to adult salamanders and the sediment protocol evaluates impacts to larval tadpoles ...the sediment protocol evaluates impacts to larval tadpoles . When selecting appropriate receptors to derive ERA-based remedial goals, amphibians...Sediment tests are conducted with recently hatched tadpoles (i.e., Rana pipiens; Gosner Stages 17-20). Young tadpoles are placed in beakers

NHEXAS PHASE I MARYLAND STUDY--LIST OF AVAILABLE DOCUMENTS: PROTOCOLS AND SOPS

EPA Science Inventory

This document lists available protocols and SOPs for the NHEXAS Phase I Maryland study. It identifies protocols and SOPs for the following study components: (1) Sample collection and field operations, (2) Sample analysis and general laboratory procedures, (3) Data Analysis Proced...

Accelerated Storage Stability and Corrosion Characteristics Study Protocol

EPA Pesticide Factsheets

EPA has determined that studies using this protocol will, in certain circumstances, provide the Agency with all the information it needs to make a determination on the storage stability of pesticides.

Eustachian tube function in adults without middle ear disease.

PubMed

Swarts, J Douglas; Alper, Cuneyt M; Mandel, Ellen M; Villardo, Richard; Doyle, William J

2011-04-01

We sought to develop normative values for 5 eustachian tube function (ETF) test protocols in adults without otitis media (OM). Twenty adults (19 to 48 years of age) without a recent history of OM (5 had OM in childhood) underwent unilateral myringotomy and were evaluated for ETF by use of the forced response, inflation, deflation, forcible "sniff", and Valsalva test protocols. When possible, these tests were repeated on a second day. Normative values for the parameters of these protocols in adult subjects without a recent history of OM were developed. Between-day data for the forced response test were highly correlated. A percentage of these tests showed eustachian tube "constriction" during swallowing--an abnormal condition. The percent reduction in applied pressures for the inflation and deflation tests was high, indicative of good ETF. Few subjects had a positive "sniff" test, whereas most had a positive Valsalva test, and the results for both tests were effort-dependent. Results of ETF tests in adults with and without recent OM have not been published. Normative data are now available for comparison with ETF test results in adults with OM. These protocols will be used to evaluate the efficacy of surgical procedures designed to improve ETF.

Young adult non-smokers' exposure to real-world tobacco marketing: results of an ecological momentary assessment pilot study.

PubMed

Rose, Shyanika W; Anesetti-Rothermel, Andrew; Elmasry, Hoda; Niaura, Ray

2017-08-31

The aims of this pilot study were to assess and characterize non-current smoking young adults' exposure to tobacco marketing through an ecological momentary assessment protocol. Ecological momentary assessment (EMA) consists of repeated measurement of momentary phenomena and is well-suited to capture sporadic experiences in the real-world, such as exposure to tobacco marketing. EMA has the potential to capture detailed information about real-world marketing exposures in ways that reduce recall bias and increase ecological validity. In this study, young adults (n = 31; ages 18-25) responded to random prompts regarding their momentary exposure to tobacco marketing via text messages on their smartphones for 14 days (n = 1798 observations). Unadjusted and adjusted analyses were conducted using multilevel logistic regression to assess the odds of exposure accounting for correlation of multiple repeated measures within individuals while controlling for variability between individuals. Respondents reported, on average, two momentary exposures to tobacco advertising in the 14-day study period. In adjusted analyses, African-American (aOR 3.36; 95% CI 1.07, 10.54) and Hispanic respondents (aOR 5.08; 95% CI 1.28, 20.13) were more likely to report exposure to tobacco advertising. Respondents were also more likely to report exposure when also exposed to others using tobacco products and when they were at stores compared with at home (aOR 14.82; 95% CI 3.61, 60.88). Non-smoking young adults report exposure to tobacco marketing particularly at the point-of-sale, with the highest likelihood of exposure among African-American and Hispanic young people. EMA protocols can be effective in assessing the potential impact of point-of-sale tobacco marketing on young adults.

A comparative study of wireless sensor networks and their routing protocols.

PubMed

Bhattacharyya, Debnath; Kim, Tai-hoon; Pal, Subhajit

2010-01-01

Recent developments in the area of micro-sensor devices have accelerated advances in the sensor networks field leading to many new protocols specifically designed for wireless sensor networks (WSNs). Wireless sensor networks with hundreds to thousands of sensor nodes can gather information from an unattended location and transmit the gathered data to a particular user, depending on the application. These sensor nodes have some constraints due to their limited energy, storage capacity and computing power. Data are routed from one node to other using different routing protocols. There are a number of routing protocols for wireless sensor networks. In this review article, we discuss the architecture of wireless sensor networks. Further, we categorize the routing protocols according to some key factors and summarize their mode of operation. Finally, we provide a comparative study on these various protocols.

Implementation of a timed, electronic, assessment-driven potassium-replacement protocol.

PubMed

Zielenski, Christopher; Crabtree, Adam; Le, Tien; Marlatt, Alyse; Ng, Dana; Tran, Alan

2017-06-15

The adherence to and effectiveness and safety of a timed, electronic, assessment-driven potassium-replacement protocol (TARP) were compared with an electronic nurse-driven replacement protocol (NRP) are reported. A retrospective observational study was conducted in a community hospital evaluating protocol adherence, effectiveness, and safety for 2 potassium-replacement protocols. All adults on medical units with an order for potassium replacement per protocol during the 3-month trial periods were reviewed. All patients requiring potassium replacement per protocol were included in the analysis. Adherence to the protocol was assessed by evaluating the dose of potassium administered and performance of reassessments. Effectiveness of the protocol was assessed by evaluating the time to achieve target potassium levels. Safety was assessed by evaluating the route of administration and occurrence of hyperkalemia. A total of 300 patients treated using potassium-replacement protocols required potassium replacement during the study period, with 148 patients in the NRP group requiring 491 instances of potassium replacement. In the TARP group a total of 564 instances requiring potassium replacement corresponded to 152 patients. Of the 491 instances requiring replacement in the NRP group, the correct dose was administered and reassessment performed 117 times (23.8%). Overall adherence ( p < 0.05), correct dose given ( p < 0.05), average time from blood draw to potassium replacement ( p < 0.0001), use of oral replacement ( p < 0.05), and time to achieve target potassium level within 12 hours ( p < 0.05) were significantly improved in the TARP group. The TARP improved the effectiveness and safety of potassium-replacement therapy over the traditional NRP without negatively affecting timeliness of care. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study Protocol.

PubMed

Hensel, Kendi L; Carnes, Michael S; Stoll, Scott T

2016-11-01

The structural and physiologic changes in a woman's body during pregnancy can predispose pregnant women to low back pain and its associated disability, as well as to complications of pregnancy, labor, and delivery. Anecdotal and empirical evidence has indicated that osteopathic manipulative treatment (OMT) may be efficacious in improving pain and functionality in women who are pregnant. Based on that premise, the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was designed as a prospective, randomized, placebo-controlled, and blinded clinical trial to evaluate the efficacy of an OMT protocol for pain during third-trimester pregnancy. The OMT protocol developed for the PROMOTE study was based on physiologic theory and the concept of the interrelationship of structure and function. The 12 well-defined, standardized OMT techniques used in the protocol are commonly taught at osteopathic medical schools in the United States. These techniques can be easily replicated as a 20-minute protocol applied in conjunction with usual prenatal care, thus making it feasible to implement into clinical practice. This article presents an overview of the study design and treatment protocols used in the PROMOTE study.

Right hemisphere damage: Communication processing in adults evaluated by the Brazilian Protocole MEC - Bateria MAC.

PubMed

Fonseca, Rochele Paz; Fachel, Jandyra Maria Guimarães; Chaves, Márcia Lorena Fagundes; Liedtke, Francéia Veiga; Parente, Maria Alice de Mattos Pimenta

2007-01-01

Right-brain-damaged individuals may present discursive, pragmatic, lexical-semantic and/or prosodic disorders. To verify the effect of right hemisphere damage on communication processing evaluated by the Brazilian version of the Protocole Montréal d'Évaluation de la Communication (Montreal Communication Evaluation Battery) - Bateria Montreal de Avaliação da Comunicação, Bateria MAC, in Portuguese. A clinical group of 29 right-brain-damaged participants and a control group of 58 non-brain-damaged adults formed the sample. A questionnaire on sociocultural and health aspects, together with the Brazilian MAC Battery was administered. Significant differences between the clinical and control groups were observed in the following MAC Battery tasks: conversational discourse, unconstrained, semantic and orthographic verbal fluency, linguistic prosody repetition, emotional prosody comprehension, repetition and production. Moreover, the clinical group was less homogeneous than the control group. A right-brain-damage effect was identified directly, on three communication processes: discursive, lexical-semantic and prosodic processes, and indirectly, on pragmatic process.

Assessment of Preschooler's Scientific Reasoning in Adult-Child Interactions: What Is the Optimal Context?

NASA Astrophysics Data System (ADS)

Meindertsma, Heidi B.; van Dijk, Marijn W. G.; Steenbeek, Henderien W.; van Geert, Paul L. C.

2014-04-01

In educational settings, continuous assessment of the child's level of understanding is necessary to effectively utilize the principles of scaffolding and to create contexts that can advance the scientific reasoning of the child. In this article, we argue that a child's performance is a dynamic notion that is created by all elements in an interaction, including the task. Therefore, we studied preschoolers' levels of scientific reasoning varying different properties of the assessment context. Young children were interviewed about four scientific tasks using one out of four different protocols (varying in the degree of flexibility and adaptiveness) by an adult. In the first study, different task contents resulted in different performance levels. The second study indicated that the most structured protocol elicited the highest maximum level of reasoning in children and the highest percentage of correct predictions. The third study showed differences between the protocols in the adult's verbal behavior. Adaptation in verbal behavior to different children by the adult did not result in higher scientific understanding by the children, whereas a higher degree of task structure did. Combined, the studies emphasize the importance of context, which has implications for assessment and teaching situations.

Development and validation of hospital information system-generated indicators of the appropriateness of oral anticoagulant prescriptions in hospitalised adults: the PACHA study protocol

PubMed Central

Petit-Monéger, Aurélie; Thiessard, Frantz; Jouhet, Vianney; Noize, Pernelle; Berdaï, Driss; Kret, Marion; Sitta, Rémi; Salmi, Louis-Rachid; Saillour-Glénisson, Florence

2017-01-01

Introduction The appropriateness of oral anticoagulant prescriptions is a major challenge to improve quality and safety of care. As indicators of the appropriateness of oral anticoagulant prescriptions are lacking, the aim of the study is to develop and validate a panel of such indicators, in hospitalised adults, from the hospital information system of two university hospitals in France. Methods and analysis The study will be carried out in four steps: (1) a literature review to identify indicators of the appropriateness of oral anticoagulant prescriptions and their conditions of appropriateness; (2) a Delphi consensus method to assess the potential utility and operational implementation of the selected indicators; (3) techniques of medical data search to implement indicators from the hospital information system and; (4) a cross-sectional study to assess the ability of indicators to detect inappropriate oral anticoagulant prescriptions, performance of medical data search techniques for tracking or retrieving information and the ability of tools to be transferred into other institutions. The fourth step will include up to 80 patient hospital stays for each indicator, depending on the prevalence of inappropriate prescriptions estimated in interim analyses. Ethics and dissemination This work addresses the current lack of quality indicators of the appropriateness of oral anticoagulant prescriptions. We aim to develop and validate such indicators for integrating them into hospital clinical practice, as part of a structured approach to improve quality and safety of care. As each hospital information system is different, we will propose tools transferable to other healthcare institutions to allow an automated construction of these indicators. The PACHA study protocol was approved by institutional review boards and ethics committees (CPP Sud-Ouest et Outre Mer III—DC 2016/119; CPP Ile-de-France II—CDW_2016_0014). Registration details Clinical Trial.gov registration

A study protocol of a randomised controlled trial to investigate if a community based strength training programme improves work task performance in young adults with Down syndrome.

PubMed

Shields, Nora; Taylor, Nicholas F; Fernhall, Bo

2010-03-25

Muscle strength is important for young people with Down syndrome as they make the transition to adulthood, because their workplace activities typically emphasise physical rather than cognitive skills. Muscle strength is reduced up to 50% in people with Down syndrome compared to their peers without disability. Progressive resistance training improves muscle strength and endurance in people with Down syndrome. However, there is no evidence on whether it has an effect on work task performance or physical activity levels. The aim of this study is to investigate if a student-led community-based progressive resistance training programme can improve these outcomes in adolescents and young adults with Down syndrome. A randomised controlled trial will compare progressive resistance training with a control group undertaking a social programme. Seventy adolescents and young adults with Down syndrome aged 14-22 years and mild to moderate intellectual disability will be randomly allocated to the intervention or control group using a concealed method. The intervention group will complete a 10-week, twice a week, student-led progressive resistance training programme at a local community gymnasium. The student mentors will be undergraduate physiotherapy students. The control group will complete an arts/social programme with a student mentor once a week for 90 minutes also for 10 weeks to control for the social aspect of the intervention. Work task performance (box stacking, pail carry), muscle strength (1 repetition maximum for chest and leg press) and physical activity (frequency, duration, intensity over 7-days) will be assessed at baseline (Week 0), following the intervention (Week 11), and at 3 months post intervention (Week 24) by an assessor blind to group allocation. Data will be analysed using ANCOVA with baseline measures as covariates. This paper outlines the study protocol for a randomised controlled trial on the effects of progressive resistance training on work task

Development of the Commonwealth of Puerto Rico National Protocol for the Management of Victims of Sexual Violence: Adults/Adolescents.

PubMed

Méndez, Rose Marie; Kulbok, Pamela; Lawson, Sarah; Matos, Abigail

2013-01-01

Sexual violence is a public health problem in Puerto Rico (PR), with an incidence of 7.4 cases for every 10,000 people during 2005-2006 (Departamento de Salud Secretaría Auxiliar de Salud Familiar y Servicios Integrados, 2007). Findings from the literature review indicated that the traditional model of care provided to the victims of sexual violence in the Emergency Department is incomplete; furthermore, it may cause revictimization because of the attitudes, behaviors, and practices of the community service providers, resulting in additional trauma. Emerging evidence demonstrates that Sexual Assault Nurse Examiner (SANE) programs are providing effective quality care. In PR, SANEs do not intervene in sexual assault cases; nevertheless, the Department of Health of PR has recognized the importance of SANE intervention. Consequently, there is a need for current evidence-based protocols and standards of care to describe the procedures, roles, and responsibilities for the provision of quality care to victims. This project involves the implementation of the Stufflebeam's Context-Input-Process-Product Model in the creation of the Commonwealth of Puerto Rico National Protocol for the Management of Victims of Sexual Violence: Adults/Adolescents.

A cognitive-behavioral intervention for emotion regulation in adults with high-functioning autism spectrum disorders: study protocol for a randomized controlled trial.

PubMed

Kuroda, Miho; Kawakubo, Yuki; Kuwabara, Hitoshi; Yokoyama, Kazuhito; Kano, Yukiko; Kamio, Yoko

2013-07-23

Adults with high-functioning autism spectrum disorders (ASD) have difficulties in social communication; thus, these individuals have trouble understanding the mental states of others. Recent research also suggests that adults with ASD are unable to understand their own mental states, which could lead to difficulties in emotion-regulation. Some studies have reported the efficacy of cognitive-behavioral therapy (CBT) in improving emotion-regulation among children with ASD. The current study will investigate the efficacy of group-based CBT for adults with ASD. The study is a randomized, waitlist controlled, single-blinded trial. The participants will be 60 adults with ASD; 30 will be assigned to a CBT group and 30 to a waitlist control group. Primary outcome measures are the 20-item Toronto Alexithymia Scale, the Coping Inventory for Stressful Situations, the Motion Picture Mind-Reading task, and an ASD questionnaire. The secondary outcome measures are the Center for Epidemiological Studies Depression Scale, the World Health Organization Quality of Life Scale 26-item version, the Global Assessment of Functioning, State-trait Anxiety Inventory, Social Phobia and Anxiety Inventory, and Liebowitz Social Anxiety Scale. All will be administered during the pre- and post-intervention, and 12 week follow-up periods. The CBT group will receive group therapy over an 8 week period (one session per week) with each session lasting approximately 100 minutes. Group therapy will consist of four or five adults with ASD and two psychologists. We will be using visual materials for this program, mainly the Cognitive Affective Training kit. This trial will hopefully indicate the efficacy of group-based CBT for adults with high- functioning ASD. This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry No. UMIN000006236.

Study protocol: longitudinal study of the transition of young people with complex health needs from child to adult health services

PubMed Central

2013-01-01

Background Young people with complex health needs have impairments that can limit their ability to carry out day-to-day activities. As well as coping with other developmental transitions, these young people must negotiate the transfer of their clinical care from child to adult services. The process of transition may not be smooth and both health and social outcomes may suffer. Increasingly, policy-makers have recognised the need to ensure a smoother transition between children’s and adult services, with processes that are holistic, individualised, and person-centred; however, there is little outcome data to support proposed models of care. This study aims to identify the features of transitional care that are potentially effective and efficient for young people with complex health needs making their transition. Methods/Design Longitudinal cohort study. 450 young people aged 14 years to 18 years 11 months (with autism spectrum disorder and an additional mental health problem, cerebral palsy or diabetes) will be followed through their transition from child to adult services and will contribute data at baseline, 12, 24 and 36 months. We will collect data on: health and wellbeing outcomes (participation, quality of life, satisfaction with services, generic health status (EQ-5D-Y) and condition specific measure of disease control or management); exposure to proposed beneficial features of services (such as having a key worker, appropriate involvement of parents); socio-economic characteristics of the sample; use of condition-related health and personal social services; preferences for the characteristics of transitional care. We will us regression techniques to explore how outcomes vary by exposure to service features and by characteristics of the young people. These data will populate a decision-analytic model comparing the costs and benefits of potential alternative ways of organising transition services. In order to better understand mechanisms and aid

Treatment outcomes after implementation of an adapted WHO protocol for severe sepsis and septic shock in Haiti.

PubMed

Papali, Alfred; Eoin West, T; Verceles, Avelino C; Augustin, Marc E; Nathalie Colas, L; Jean-Francois, Carl H; Patel, Devang M; Todd, Nevins W; McCurdy, Michael T

2017-10-01

The World Health Organization (WHO) has developed a simplified algorithm specific to resource-limited settings for the treatment of severe sepsis emphasizing early fluids and antibiotics. However, this protocol's clinical effectiveness is unknown. We describe patient outcomes before and after implementation of an adapted WHO severe sepsis protocol at a community hospital in Haiti. Using a before-and-after study design, we retrospectively enrolled 99 adult Emergency Department patients with severe sepsis from January through March 2012. After protocol implementation in January 2014, we compared outcomes to 67 patients with severe sepsis retrospectively enrolled from February to April 2014. We defined sepsis according to the WHO's Integrated Management of Adult Illness guidelines and severe sepsis as sepsis plus organ dysfunction. After protocol implementation, quantity of fluid administered increased and the physician's differential diagnoses more often included sepsis. Patients were more likely to have follow-up vital signs taken sooner, a radiograph performed, and a lactic acid tested. There were no improvements in mortality, time to fluids or antimicrobials. Use of a simplified sepsis protocol based primarily on physiologic parameters allows for substantial improvements in process measures in the care of severely septic patients in a resource-constrained setting. Copyright © 2017 Elsevier Inc. All rights reserved.

Standardized food images: A photographing protocol and image database.

PubMed

Charbonnier, Lisette; van Meer, Floor; van der Laan, Laura N; Viergever, Max A; Smeets, Paul A M

2016-01-01

The regulation of food intake has gained much research interest because of the current obesity epidemic. For research purposes, food images are a good and convenient alternative for real food because many dietary decisions are made based on the sight of foods. Food pictures are assumed to elicit anticipatory responses similar to real foods because of learned associations between visual food characteristics and post-ingestive consequences. In contemporary food science, a wide variety of images are used which introduces between-study variability and hampers comparison and meta-analysis of results. Therefore, we created an easy-to-use photographing protocol which enables researchers to generate high resolution food images appropriate for their study objective and population. In addition, we provide a high quality standardized picture set which was characterized in seven European countries. With the use of this photographing protocol a large number of food images were created. Of these images, 80 were selected based on their recognizability in Scotland, Greece and The Netherlands. We collected image characteristics such as liking, perceived calories and/or perceived healthiness ratings from 449 adults and 191 children. The majority of the foods were recognized and liked at all sites. The differences in liking ratings, perceived calories and perceived healthiness between sites were minimal. Furthermore, perceived caloric content and healthiness ratings correlated strongly (r ≥ 0.8) with actual caloric content in both adults and children. The photographing protocol as well as the images and the data are freely available for research use on http://nutritionalneuroscience.eu/. By providing the research community with standardized images and the tools to create their own, comparability between studies will be improved and a head-start is made for a world-wide standardized food image database. Copyright © 2015 Elsevier Ltd. All rights reserved.

The effect of an information and communication technology (ICT) on older adults' quality of life: study protocol for a randomized control trial.

PubMed

Gustafson, David H; McTavish, Fiona; Gustafson, David H; Mahoney, Jane E; Johnson, Roberta A; Lee, John D; Quanbeck, Andrew; Atwood, Amy K; Isham, Andrew; Veeramani, Raj; Clemson, Lindy; Shah, Dhavan

2015-04-25

This study investigates the use of an information and communication technology (Elder Tree) designed for older adults and their informal caregivers to improve older adult quality of life and address challenges older adults face in maintaining their independence (for example, loneliness and isolation, falling, managing medications, driving and transportation). This study, an unblinded randomized controlled trial, will evaluate the effectiveness and cost of Elder Tree. Older adults who are at risk for losing their independence - along with their informal caregivers, if they name them - are randomized to two groups. The intervention group has access to their usual sources of information and communication as well as to Elder Tree for 18 months while the control group uses only their usual sources of information and communication. The primary outcome of the study is older adult quality of life. Secondary outcomes are cost per Quality-Adjusted Life Year and the impact of the technology on independence, loneliness, falls, medication management, driving and transportation, and caregiver appraisal and mastery. We will also examine the mediating effect of self-determination theory. We will evaluate the effectiveness of Elder Tree by comparing intervention- and control-group participants at baseline and months 6, 12, and 18. We will use mixed-effect models to evaluate the primary and secondary outcomes, where pretest score functions as a covariate, treatment condition is a between-subjects factor, and the multivariate outcome reflects scores for a given assessment at the three time points. Separate analyses will be conducted for each outcome. Cost per Quality-Adjusted Life Year will be compared between the intervention and control groups. Additional analyses will examine the mediating effect of self-determination theory on each outcome. Elder Tree is a multifaceted intervention, making it a challenge to assess which services or combinations of services account for outcomes in

A randomised controlled intervention study investigating the efficacy of carotenoid-rich fruits and vegetables and extra-virgin olive oil on attenuating sarcopenic symptomology in overweight and obese older adults during energy intake restriction: protocol paper.

PubMed

Villani, Anthony; Wright, Hattie; Slater, Gary; Buckley, Jonathan

2018-01-05

Weight loss interventions have not been advocated for overweight/obese older adults due to potential loss of skeletal muscle and strength impacting on physical function with potential loss of independence. Carotenoids and polyphenols are inversely associated with sarcopenic symptomology. This paper reports the protocol of a study evaluating the efficacy of a high-protein, energy restricted diet rich in carotenoids and polyphenols on body composition, muscle strength, physical performance and quality of life in overweight and obese older adults. This randomised controlled clinical trial will recruit community-dwelling, healthy overweight and obese older adults (≥60 years) for a 12-week weight loss intervention. Seventy-three participants will be recruited and randomized to an energy restricted (~30% restriction), isocaloric diet (30% protein; 30% carbohydrate; 40% fat) enriched with either: a) 375 g/d of high carotenoid vegetables, 300 g/d high carotenoid fruit, and 40-60 ml extra-virgin olive oil (EVOO); or b) 375 g/d of lower carotenoid vegetables, 300 g/d lower carotenoid fruit, and 40-60 ml Polyunsaturated fatty acid (PUFA) based oil. All participants will receive individual dietary counselling each fortnight for the duration of the study and will be asked to maintain their habitual level of physical activity throughout the study. The primary outcome will be appendicular skeletal muscle (ASM) assessed by dual energy X-ray absorptiometry (DXA). Secondary outcomes will include body weight, fat-free mass (FFM), fat mass (FM), muscle strength (Isometric hand-grip strength), physical performance (Short Physical Performance Battery), physical activity (International Physical Activity Questionnaire) and health related quality of life (SF-36). Outcomes will be measured at baseline and at week 12. The results of this study will provide a novel insight relating to the potential influence of high carotenoid and polyphenol intakes on attenuation of ASM during

Why are some people more fit than others? Correlates and determinants of cardiorespiratory fitness in adults: protocol for a systematic review.

PubMed

Perumal, Nita; Mensink, Gert B M; Keil, Thomas; Finger, Jonas David

2017-05-18

Cardiorespiratory fitness (CRF) is a physical condition that is now well established as a predictor of numerous adverse health outcomes, independent of physical activity levels. In order to be able to improve CRF at the population level and to develop effective interventions and public health programmes, it is important to understand why some people are more fit than others. Therefore, the primary aim of the systematic review described in this protocol is to examine individual and interpersonal factors that are correlated with or determine CRF among adults. The review will focus on quantitative studies that investigate any personal and interpersonal correlates and/or determinants of objectively measured CRF among the general, non-symptomatic, non-institutionalized adult population (aged 18-65 years) worldwide. The databases MEDLINE, Embase, and Cochrane Library will be searched to identify all relevant published journal articles, and Google Scholar and Scopus will be searched for grey literature. Studies where CRF is not an outcome variable and experimental studies where participants specifically receive a fitness intervention that increases CRF will be excluded. For each study, data extracted will include, among other variables, study characteristics, methodology for selecting participants into the study as well as the participants' demographic characteristics, types of correlates and determinants of CRF investigated and their measurement methods, the objective measure of CRF used and its measurement method and validity, and the main reported results on the association between the correlates or determinants and CRF. In addition, observational studies will be assessed for methodological quality and risk of bias using a customized version of the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies by the National Heart, Lung, and Blood Institute. Experimental studies will be assessed using the 27-item Downs and Black "Checklist for Measuring

Comparison of 2 intravenous insulin protocols: Glycemia variability in critically ill patients.

PubMed

Gómez-Garrido, Marta; Rodilla-Fiz, Ana M; Girón-Lacasa, María; Rodríguez-Rubio, Laura; Martínez-Blázquez, Anselmo; Martínez-López, Fernando; Pardo-Ibáñez, María Dolores; Núñez-Marín, Juan M

2017-05-01

Glycemic variability is an independent predictor of mortality in critically ill patients. The objective of this study was to compare two intravenous insulin protocols in critically ill patients regarding the glycemic variability. This was a retrospective observational study performed by reviewing clinical records of patients from a Critical Care Unit for 4 consecutive months. First, a simpler Scale-Based Intravenous Insulin Protocol (SBIIP) was reviewed and later it was compared for the same months of the following year with a Sliding Scale-Based Intravenous Insulin Protocol (SSBIIP). All adult patients admitted to the unit during the referred months were included. Patients in whom the protocol was not adequately followed were excluded. A total of 557 patients were reviewed, of whom they had needed intravenous insulin 73 in the first group and 52 in the second group. Four and two patients were excluded in each group respectively. Glycemic variability for both day 1 (DS1) and total stay (DST) was lower in SSBIIP patients compared to SBIIP patients: SD1 34.88 vs 18.16 and SDT 36.45 vs 23.65 (P<.001). A glycemic management protocol in critically ill patients based on sliding scales decreases glycemic variability. Copyright © 2017 SEEN. Publicado por Elsevier España, S.L.U. All rights reserved.

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol

PubMed Central

Agot, Kawango

2017-01-01

Background Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. Objective The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. Methods The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. Results The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3

Cognitive behaviour therapy for generalized anxiety disorder: Is CBT equally efficacious in adults of working age and older adults?

PubMed

Kishita, Naoko; Laidlaw, Ken

2017-03-01

The current meta-analysis compared the efficacy of CBT for GAD between adults of working age and older people. In addition, we conducted a qualitative content analysis of treatment protocols used in studies with older clients to explore potential factors that may enhance treatment outcomes with this particular client group. Applying the inclusion criteria resulted in the identification of 15 studies with 22 comparisons between CBT and control groups (770 patients). When examining overall effect sizes for CBT for GAD between older people and adults of working age there were no statistically significant differences in outcome. However, overall effect size of CBT for GAD was moderate for older people (g=0.55, 95% CI 0.22-0.88) and large for adults of working age (g=0.94, 95% CI 0.52-1.36), suggesting that there is still room for improvement in CBT with older people. The main difference in outcome between CBT for GAD between the two age groups was related to methodological quality in that no older people studies used an intention-to-treat design. The content analysis demonstrated that studies with older clients were conducted according to robust CBT protocols but did not take account of gerontological evidence to make them more age-appropriate. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Validation of Transtek blood pressure monitor TMB-1491 for self-measurement according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Tian, Huiyong; Zeng, Sijian; Zhong, Xiaoyan; Gong, Wei; Liu, Wenjun

2015-10-01

Transtek blood pressure monitor TMB-1491 is an automatic upper arm device designed for self/home measurement in adult populations. This study aimed to evaluate its accuracy according to the European Society of Hypertension International Protocol revision 2010. The protocol requirements were followed precisely with the recruitment of 33 adult individuals on whom same-left-arm sequential systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. According to the validation protocol, 99 pairs of test device and reference blood pressure measurements were obtained in this study (three pairs for each of the 33 participants). The device produced 74, 95 and 99 measurements within 5, 10, and 15 mmHg for SBP and 85, 97, and 99 for DBP, respectively. The mean±SD device-observer difference was -0.6±4.4 mmHg for SBP and -0.6±3.4 mmHg for DBP. The number of participants with two or three device-observer difference within 5 mmHg was 24 for SBP and 29 for DBP. In addition, none of the participants had a device-observer difference within 5 mmHg for SBP, and three of the participants had the same for DBP. Transtek TMB-1491 has passed all phases of European Society of Hypertension International Protocol revision 2010 and can be recommended for self/home measurement in adult populations.

Effectiveness of alternative listening devices to conventional hearing aids for adults with hearing loss: a systematic review protocol.

PubMed

Maidment, David W; Barker, Alex B; Xia, Jun; Ferguson, Melanie A

2016-10-27

Hearing loss is a major public health concern, affecting over 11 million people in the UK. While hearing aids are the most common clinical intervention for hearing loss, the majority of people that would benefit from using hearing aids do not take them up. Recent technological advances have led to a rapid increase of alternative listening devices to conventional hearing aids. These include hearing aids that can be customised using a smartphone, smartphone-based 'hearing aid' apps, personal sound amplification products and wireless hearing products. However, no systematic review has been published evaluating whether alternative listening devices are an effective management strategy for people with hearing loss. The objective of this systematic review is to assess whether alternative listening devices are an effective intervention for adults with hearing loss. Methods are reported according to the Preferred Reporting Items for Systematic reviews and Meta-analyses Protocols (PRISMA-P) 2015 checklist. Retrospective or prospective studies, randomised controlled trials, non-randomised controlled trials, and before-after comparison studies will be eligible for inclusion. We will include studies with adult participants (≥18 years) with a mild or moderate hearing loss. The intervention should be an alternative listening device to a conventional hearing aid (comparison). Studies will be restricted to outcomes associated with the consequences of hearing loss. We will search relevant databases to identify published, completed but unpublished and ongoing trials. The overall quality of included evidence will be evaluated using the GRADE system, and meta-analysis performed if appropriate. No ethical issues are foreseen. The findings will be reported at national and international conferences, primarily audiology, and ear, nose and throat, and in a peer-reviewed journal using the PRISMA guidelines. PROSPERO CRD4201502958. Published by the BMJ Publishing Group Limited. For

21 CFR 58.120 - Protocol.

Code of Federal Regulations, 2010 CFR

2010-04-01

... FOR NONCLINICAL LABORATORY STUDIES Protocol for and Conduct of a Nonclinical Laboratory Study § 58.120 Protocol. (a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following...

Measurement properties of maximal cardiopulmonary exercise tests protocols in persons after stroke: A systematic review.

PubMed

Wittink, Harriet; Verschuren, Olaf; Terwee, Caroline; de Groot, Janke; Kwakkel, Gert; van de Port, Ingrid

2017-11-21

To systematically review and critically appraise the literature on measurement properties of cardiopulmonary exercise test protocols for measuring aerobic capacity, VO2max, in persons after stroke. PubMed, Embase and Cinahl were searched from inception up to 15 June 2016. A total of 9 studies were identified reporting on 9 different cardiopulmonary exercise test protocols. VO2max measured with cardiopulmonary exercise test and open spirometry was the construct of interest. The target population was adult persons after stroke. We included all studies that evaluated reliability, measurement error, criterion validity, content validity, hypothesis testing and/or responsiveness of cardiopulmonary exercise test protocols. Two researchers independently screened the literature, assessed methodological quality using the COnsensus-based Standards for the selection of health Measurement INstruments checklist and extracted data on measurement properties of cardiopulmonary exercise test protocols. Most studies reported on only one measurement property. Best-evidence synthesis was derived taking into account the methodological quality of the studies, the results and the consistency of the results. No judgement could be made on which protocol is "best" for measuring VO2max in persons after stroke due to lack of high-quality studies on the measurement properties of the cardiopulmonary exercise test.

Analyzing the effect of routing protocols on media access control protocols in radio networks

DOE Office of Scientific and Technical Information (OSTI.GOV)

Barrett, C. L.; Drozda, M.; Marathe, A.

2002-01-01

We study the effect of routing protocols on the performance of media access control (MAC) protocols in wireless radio networks. Three well known MAC protocols: 802.11, CSMA, and MACA are considered. Similarly three recently proposed routing protocols: AODV, DSR and LAR scheme 1 are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of our experiments was to study how the routing protocols affect the performance of the MAC protocols when the underlying network and traffic parameters are varied. The performance of the protocols was measured w.r.t. five important parameters: (i)more » number of received packets, (ii) average latency of each packet, (iii) throughput (iv) long term fairness and (v) number of control packets at the MAC layer level. Our results show that combinations of routing and MAC protocols yield varying performance under varying network topology and traffic situations. The result has an important implication; no combination of routing protocol and MAC protocol is the best over all situations. Also, the performance analysis of protocols at a given level in the protocol stack needs to be studied not locally in isolation but as a part of the complete protocol stack. A novel aspect of our work is the use of statistical technique, ANOVA (Analysis of Variance) to characterize the effect of routing protocols on MAC protocols. This technique is of independent interest and can be utilized in several other simulation and empirical studies.« less

Pediatric Renal Transplantation: Focus on Current Transition Care and Proposal of the "RISE to Transition" Protocol.

PubMed

Raina, Rupesh; Wang, Joseph; Krishnappa, Vinod; Ferris, Maria

2018-01-16

The transition from pediatric to adult medical services is an important time in the life of an adolescent or young adult with a renal transplant. Failure of proper transition can lead to medical non-adherence and subsequent loss of graft and/or return to dialysis. The aim of this study was to conduct a systematic review and survey to assess the challenges and existing practices in transition of renal transplant recipient children to adult services, and to develop a transition protocol. We conducted a literature review and performed a survey of pediatric nephrologists across the United States to examine the current state of transition care. A structured transition protocol was developed based on these results. Our literature review revealed that a transition program has a positive impact on decline in renal function and acute rejection episodes, and may improve long-term graft outcomes in pediatric kidney transplant patients. With a response rate of 40% (60/150) from nephrologists in 56% (49/87) of centers, our survey shows inconsistent use of validated tools despite their availability, inefficient communication between teams, and lack of use of dedicated clinics. To address these issues, we developed the "RISE to Transition" protocol, which relies on 4 competency areas: Recognition, Insight, Self-reliance, and Establishment of healthy habits. The transition program decreases acute graft rejection episodes, and the main challenges in transition care are the communication gap between health care providers and inconsistent use of transition tools. Our RISE to transition protocol incorporates transition tools, defines personnel, and aims to improve communication between teams.

Test-retest reliability of a balance testing protocol with external perturbations in young healthy adults.

PubMed

Robbins, Shawn M; Caplan, Ryan M; Aponte, Daniel I; St-Onge, Nancy

2017-10-01

External perturbations are utilized to challenge balance and mimic realistic balance threats in patient populations. The reliability of such protocols has not been established. The purpose was to examine test-retest reliability of balance testing with external perturbations. Healthy adults (n=34; mean age 23 years) underwent balance testing over two visits. Participants completed ten balance conditions in which the following parameters were combined: perturbation or non-perturbation, single or double leg, and eyes open or closed. Three trials were collected for each condition. Data were collected on a force plate and external perturbations were applied by translating the plate. Force plate center of pressure (CoP) data were summarized using 13 different CoP measures. Test-retest reliability was examined using intraclass correlation coefficients (ICC) and Bland-Altman plots. CoP measures of total speed and excursion in both anterior-posterior and medial-lateral directions generally had acceptable ICC values for perturbation conditions (ICC=0.46 to 0.87); however, many other CoP measures (e.g. range, area of ellipse) had unacceptable test-retest reliability (ICC<0.70). Improved CoP measures were present on the second visit indicating a potential learning effect. Non-perturbation conditions generally produced more reliable CoP measures than perturbation conditions during double leg standing, but not single leg standing. Therefore, changes to balance testing protocols that include external perturbations should be made to improve test-retest reliability and diminish learning including more extensive participant training and increasing the number of trials. CoP measures that consider all data points (e.g. total speed) are more reliable than those that only consider a few data points. Copyright © 2017 Elsevier B.V. All rights reserved.

Effectiveness and safety of a high-dose weekly vitamin D (20,000 IU) protocol in older adults living in residential care.

PubMed

Feldman, Fabio; Moore, Crystal; da Silva, Liz; Gaspard, Gina; Gustafson, Larry; Singh, Sonia; Barr, Susan I; Kitts, David D; Li, Wangyang; Weiler, Hope A; Green, Timothy J

2014-08-01

To report 25 hydroxyvitamin D (25OHD) concentrations, an indicator of vitamin D status, in older adults living in residential care 1 year after a protocol of weekly 20,000 IU of vitamin D was started. Cross-sectional. Five residential care facilities in British Columbia, Canada. Residents aged 65 and older from five facilities (N=236). Participants provided a blood sample. Demographic and health information was obtained from the medical record. Mean 25OHD was 102 nmol/L (95% confidence interval (CI)=98-106 nmol/L). Three percent of residents had a 25OHD concentration of less than 40 nmol/L, 6% <50 nmol/L, and 19% <75 nmol/L. In those who received 20,000 IU/wk or more for 6 months or longer (n=147), mean 25OHD was 112 nmol/L (95% CI=108-117 nmol/L), and none had a 25OHD level of less than 50 nmol/L. Hypercalcemia (>2.6 mmol/L), a potential consequence of too much vitamin D, was present in 14%, although 25OHD levels did not differ in those with and without hypercalcemia (108 vs 101 nmol/L; P=.17). Twelve months after implementation of a 20,000-IU/wk vitamin D protocol for older adults in residential care, mean 25OHD concentrations were high, and there was no evidence of poor vitamin D status. Given the absence of demonstrated benefit of high 25OHD concentrations to the residential care population, dosages less than 20,000 IU/wk of vitamin D are recommended. © 2014, Copyright the Authors Journal compilation © 2014, The American Geriatrics Society.

A Narrative Synthesis of Nintendo Wii Fit Gaming Protocol in Addressing Balance Among Healthy Older Adults: What System Works?

PubMed

Manlapaz, Donald G; Sole, Gisela; Jayakaran, Prasath; Chapple, Cathy M

2017-04-01

Balance is crucial in performing functional tasks particularly among older adults. Exergaming is gaining attention as a novel approach to enhance balance in a number of clinical populations. The aim of this review was to synthesize and present published evidence for Nintendo Wii Fit™ gaming system protocols. These include game preference, intervention setting, and exercise dosage for improving balance in healthy older adults. Commonly used outcome measures were also identified. A literature search was developed using the PICOS strategy using keywords such as "older adult," "Nintendo Wii Fit," "exergaming," and "balance" in the databases: MEDLINE, PubMed, EMBASE, CINAHL, Scopus, Science Direct, and Web of Science. Sixteen articles were included with participants (n = 491) mostly female (69%), and mean age ranged between 71 and 85 years old. Participants were recruited mainly from the community. The most commonly used Wii Fit games were Table tilt, Soccer Heading, Ski Slalom, and Ski jump, performed three times per week, with a duration of 30 minutes per session for 6 weeks. Berg Balance Scale, Timed Up and Go Test, and Centre of Pressure were the most commonly used outcome measures. Wii Fit exergames can be a potential alternative to improve balance if safety and technical procedures are provided. With conflicting and mechanism-based evidence on dosage presented, exergaming parameters require further research before firm recommendations can be made. Clinically, effective dosage is an important component in any type of interventions, and exergaming should not be an exception.

Bioindicators in the MIDUS National Study: Protocol, Measures, Sample, and Comparative Context

PubMed Central

Love, Gayle Dienberg; Seeman, Teresa E.; Weinstein, Maxine; Ryff, Carol D.

2010-01-01

Objectives MIDUS is a national study of health and aging among individuals aged 25 to 74 at baseline(1995/96). Longitudinal survey assessments (2004/05), were followed by biological assessments on a subsample aged 35–85. To facilitate public use, we describe the protocol, measures, and sample. Methods Respondents traveled to clinics for a two-day data collection protocol that included fasting blood specimens, 12-hour urine specimen, medical history, physical exam, bone densitometry, a laboratory challenge (heart rate variability, blood pressure, respiration, salivary cortisol). Results Response rates for the biological protocol (N = 1,255) were 39.3%, or 43.1% (adjusting for those who could not be located or contacted). Reasons for non-participation were travel, family obligations, and being too busy. Respondents were comparable to the recruitment pool on most demographic characteristics and health assessments. Discussion Strengths of the protocol vis-à-vis other similar studies include opportunities to link biological factors with diverse content from other MIDUS projects. PMID:20876364

Prevalence, awareness, and associated risk factors of hypertension in older adults in Africa: a systematic review and meta-analysis protocol.

PubMed

Bosu, William K; Aheto, Justice M K; Zucchelli, Eugenio; Reilly, Siobhan

2017-10-04

The health of older persons has not been a major priority in many African countries. Hypertension is one of the common health problems of older persons. However, there is little information on the prevalence of hypertension in older adults in Africa. This is in spite of the fact that Africa has the highest age-standardized prevalence of hypertension in the world. We therefore present this protocol to conduct a systematic review and meta-analysis on the prevalence of hypertension and the level of its awareness among older persons living in Africa. Major databases (EMBASE, MEDLINE, Academic Search Complete, CINAHL, PsycINFO) and unpublished literature will be searched to identify population-based studies on hypertension in adults aged 50 years and older living in Africa. Eligible articles are those which use the 140/90-mmHg cutoff to diagnose hypertension and were published from 1980 to present. We will exclude subjects in restricted environments such as patients and refugees. Articles will be independently evaluated by two reviewers to determine if they meet the inclusion criteria. They will also evaluate the quality of included studies using a validated tool by Hoy and colleagues for prevalence studies. The main outcome is the prevalence of hypertension while the explanatory variables include demographic, socio-economic, dietary, lifestyle and behavioural factors. Effect sizes in bivariate and multivariate analyses will be presented as odds or prevalence ratios. We will explore for heterogeneity of the standard errors across the studies, and if appropriate, we will perform a meta-analysis using a random-effects model to present a summary estimate of the prevalence of hypertension in this population. The estimates of the prevalence, the risk factors and the level of awareness of hypertension could help in galvanizing efforts at prioritizing the cardiovascular health of older persons in Africa. PROSPERO CRD42017056474.

Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010.

PubMed

de Greeff, Annemarie; Shennan, Andrew H

2013-06-01

The Tensoval Duo Control II is an automated upper arm device that uses a combination of oscillometric and auscultatory technology to determine blood pressure noninvasively. The accuracy of this device was assessed according to the British Hypertension Society (BHS) protocol and the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population. Ethical approval was obtained. Eighty-five and 33 adult individuals, respectively, were recruited to fulfil the requirements of each protocol. Trained observers took nine sequential same-arm measurements alternating between a mercury sphygmomanometer and the device. The device had to achieve at least a B grade for both systolic and diastolic pressures to pass the BHS protocol and had to fulfil the criteria of all three phases of the ESH-IP2 protocol to receive recommendation. The device achieved an A/A grading for the BHS protocol and passed all three phases of the ESH-IP2 protocol. The mean difference±SD for the BHS/ESH protocols, respectively, was -1.8±6.5/-0.7±5.7 mmHg for systolic pressure and 1.9±5.1/2.4±4.5 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low-pressure, medium-pressure and high-pressure ranges. The Tensoval Duo Control II device is recommended for clinical and home use according to both the BHS and the ESH-IP2 standard.

Guidelines and protocols for cardiovascular magnetic resonance in children and adults with congenital heart disease: SCMR expert consensus group on congenital heart disease

PubMed Central

2013-01-01

Cardiovascular magnetic resonance (CMR) has taken on an increasingly important role in the diagnostic evaluation and pre-procedural planning for patients with congenital heart disease. This article provides guidelines for the performance of CMR in children and adults with congenital heart disease. The first portion addresses preparation for the examination and safety issues, the second describes the primary techniques used in an examination, and the third provides disease-specific protocols. Variations in practice are highlighted and expert consensus recommendations are provided. Indications and appropriate use criteria for CMR examination are not specifically addressed. PMID:23763839

Adults Studying Pure Mathematics in Adult Tertiary Preparation.

ERIC Educational Resources Information Center

Bennison, Anne

2002-01-01

Investigated the experiences of a group of adults enrolled in the Pure Mathematics module of the Certificate IV in Adult Tertiary Preparation in 2000 at one of the Institutes of TAFE in Brisbane, Australia. Classroom learning experiences, exposure to technology, and the impact of returning to study on other facets of students' lives were…

Lung donor treatment protocol in brain dead-donors: A multicenter study.

PubMed

Miñambres, Eduardo; Pérez-Villares, Jose Miguel; Chico-Fernández, Mario; Zabalegui, Arturo; Dueñas-Jurado, Jose María; Misis, Maite; Mosteiro, Fernando; Rodriguez-Caravaca, Gil; Coll, Elisabeth

2015-06-01

The shortage of lung donors for transplantation is the main limitation among patients awaiting this type of surgery. We previously demonstrated that an intensive lung donor-treatment protocol succeeded in increasing the lung procurement rate. We aimed to validate our protocol for centers with or without lung transplant programs. A quasi-experimental study was performed to compare lung donor rate before (historical group, 2010 to 2012) and after (prospective group, 2013) the application of a lung management protocol for donors after brain death (DBDs) in six Spanish hospitals. Lung donor selection criteria remained unchanged in both periods. Outcome measures for lung recipients were early survival and primary graft dysfunction (PGD) rates. A total of 618 DBDs were included: 453 in the control period and 165 in the protocol period. Donor baseline characteristics were similar in both periods. Lung donation rate in the prospective group was 27.3%, more than twice that of the historical group (13%; p < 0.001). The number of lungs retrieved, grafts transplanted, and transplants performed more than doubled over the study period. No differences in early recipients' survival between groups were observed (87.6% vs. 84.5%; p = 0.733) nor in the rate of PGD. Implementing our intensive lung donor-treatment protocol increases lung procurement rates. This allows more lung transplants to be performed without detriment to either early survival or PGD rate. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Organotypic Cultures from the Adult CNS: A Novel Model to Study Demyelination and Remyelination Ex Vivo.

PubMed

Tan, Glaiza A; Furber, Kendra L; Thangaraj, Merlin P; Sobchishin, LaRhonda; Doucette, J Ronald; Nazarali, Adil J

2018-01-01

Experimental models of multiple sclerosis (MS) have significantly advanced our understanding of pathophysiology and therapeutic interventions. Although in vivo rodent models are considered to most closely represent the complex cellular and molecular disease states of the human central nervous system (CNS), these can be costly to maintain and require long timelines. Organotypic slice cultures maintain the cytotypic organization observed in the intact CNS, yet provide many of the experimental advantages of in vitro cell culture models. Cerebellar organotypic cultures have proven useful for studying myelination and remyelination, but this model has only been established using early postnatal tissue. This young brain tissue allows for neuro development ex vivo to mimic the 'mature' CNS; however, there are many differences between postnatal and adult organotypic cultures. This may be particularly relevant to MS, as a major barrier to myelin regeneration is age. This paper describes a modified protocol to study demyelination and remyelination in adult cerebellar tissue, which has been used to demonstrate neuroprotection with omega-3 fatty acids. Thus, adult cerebellar organotypic cultures provide a novel ex vivo platform for screening potential therapies in myelin degeneration and repair.

Development and validation of hospital information system-generated indicators of the appropriateness of oral anticoagulant prescriptions in hospitalised adults: the PACHA study protocol.

PubMed

Petit-Monéger, Aurélie; Thiessard, Frantz; Jouhet, Vianney; Noize, Pernelle; Berdaï, Driss; Kret, Marion; Sitta, Rémi; Salmi, Louis-Rachid; Saillour-Glénisson, Florence

2017-08-31

The appropriateness of oral anticoagulant prescriptions is a major challenge to improve quality and safety of care. As indicators of the appropriateness of oral anticoagulant prescriptions are lacking, the aim of the study is to develop and validate a panel of such indicators, in hospitalised adults, from the hospital information system of two university hospitals in France. The study will be carried out in four steps: (1) a literature review to identify indicators of the appropriateness of oral anticoagulant prescriptions and their conditions of appropriateness; (2) a Delphi consensus method to assess the potential utility and operational implementation of the selected indicators; (3) techniques of medical data search to implement indicators from the hospital information system and; (4) a cross-sectional study to assess the ability of indicators to detect inappropriate oral anticoagulant prescriptions, performance of medical data search techniques for tracking or retrieving information and the ability of tools to be transferred into other institutions. The fourth step will include up to 80 patient hospital stays for each indicator, depending on the prevalence of inappropriate prescriptions estimated in interim analyses. This work addresses the current lack of quality indicators of the appropriateness of oral anticoagulant prescriptions. We aim to develop and validate such indicators for integrating them into hospital clinical practice, as part of a structured approach to improve quality and safety of care. As each hospital information system is different, we will propose tools transferable to other healthcare institutions to allow an automated construction of these indicators. The PACHA study protocol was approved by institutional review boards and ethics committees (CPP Sud-Ouest et Outre Mer III-DC 2016/119; CPP Ile-de-France II-CDW_2016_0014). Clinical Trial.gov registration: NCT02898090. © Article author(s) (or their employer(s) unless otherwise stated in the

Health disparities among adults with developmental disabilities, adults with other disabilities, and adults not reporting disability in North Carolina.

PubMed

Havercamp, Susan M; Scandlin, Donna; Roth, Marcia

2004-01-01

The purposes of this study were (1) to identify disparities between adults with developmental disabilities and non-disabled adults in health and medical care, and (2) to compare this pattern of disparities to the pattern of disparities between adults with other disabilities and adults without disabilities. The authors compared data on health status, health risk behaviors, chronic health conditions, and utilization of medical care across three groups of adults: No Disability, Disability, and Developmental Disability. Data sources were the 2001 North Carolina Behavioral Risk Factor Surveillance System and the North Carolina National Core Indicators survey. Adults with developmental disabilities were more likely to lead sedentary lifestyles and seven times as likely to report inadequate emotional support, compared with adults without disabilities. Adults with disabilities and developmental disabilities were significantly more likely to report being in fair or poor health than adults without disabilities. Similar rates of tobacco use and overweight/obesity were reported. Adults with developmental disabilities had a similar or greater risk of having four of five chronic health conditions compared with non-disabled adults. Significant medical care utilization disparities were found for breast and cervical cancer screening as well as for oral health care. Adults with developmental disabilities presented a unique risk for inadequate emotional support and low utilization of breast and cervical cancer screenings. Significant disparities in health and medical care utilization were found for adults with developmental disabilities relative to non-disabled adults. The National Core Indicators protocol offers a sound methodology to gather much-needed surveillance information on the health status, health risk behaviors, and medical care utilization of adults with developmental disabilities. Health promotion efforts must be specifically designed for this population.

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol.

PubMed

Buttolph, Jasmine; Inwani, Irene; Agot, Kawango; Cleland, Charles M; Cherutich, Peter; Kiarie, James N; Osoti, Alfred; Celum, Connie L; Baeten, Jared M; Nduati, Ruth; Kinuthia, John; Hallett, Timothy B; Alsallaq, Ramzi; Kurth, Ann E

2017-03-08

Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (Pr

Development of a systematic observation protocol of physical exposure of the back: a preliminary study.

PubMed

Tousignant, M; Tougas, G; Rossignol, M; Goulet, L

2002-04-01

At present there is no systematic observation protocol for the assessment of the multi-factorial aspects of physical exposure related to the back used within the constraints of occupational epidemiological research. In this context, a new preliminary systematic observation protocol is proposed to assess exposure to physical loading of the back using nine categories of physical risk factors: the SOPE back protocol. The objective of this study was to investigate whether the new protocol can correctly identify the level of exposure related to measured physical loading of the back. The subjects of this closed cohort study were 451 manual workers at a natural gas distribution company. The assessment of exposure was made with the protocol using groups with different job titles. The workers were followed for a 2 yr period to establish the risk of a new occurrence of complete disability related to the back (NOCD back injury) in each job grouping. Based on the median of the total scores derived from the protocol, two levels of exposure were identified (high and low). Taking into account the limitations of this study, the protocol in development may be a good tool to establish two levels of exposure to physical loading of the back in large epidemiological studies of occupational low back pain. Further research is needed to replicate these results with larger samples and to test the reliability and predictive validity of the protocol.

A comparative study of routing protocols of heterogeneous wireless sensor networks.

PubMed

Han, Guangjie; Jiang, Xu; Qian, Aihua; Rodrigues, Joel J P C; Cheng, Long

2014-01-01

Recently, heterogeneous wireless sensor network (HWSN) routing protocols have drawn more and more attention. Various HWSN routing protocols have been proposed to improve the performance of HWSNs. Among these protocols, hierarchical HWSN routing protocols can improve the performance of the network significantly. In this paper, we will evaluate three hierarchical HWSN protocols proposed recently--EDFCM, MCR, and EEPCA--together with two previous classical routing protocols--LEACH and SEP. We mainly focus on the round of the first node dies (also called the stable period) and the number of packets sent to sink, which is an important aspect to evaluate the monitoring ability of a protocol. We conduct a lot of experiments and simulations on Matlab to analyze the performance of the five routing protocols.

Childhood socioeconomic position and adult leisure-time physical activity: a systematic review protocol.

PubMed

Elhakeem, Ahmed; Cooper, Rachel; Bann, David; Hardy, Rebecca

2014-12-05

Participation in leisure-time physical activity benefits health and is thought to be more prevalent in higher socioeconomic groups. Evidence indicates that childhood socioeconomic circumstances may have long-term influences on adult health and behaviour; however, it is unclear if this extends to an influence on adult physical activity. The aim of this review is to examine whether a lower childhood socioeconomic position is associated with lower levels of leisure-time physical activity during adulthood. Keywords will be used to systematically search five online databases and additional studies will be located through a search of reference lists. At least two researchers working independently will screen search results assess the quality of included studies and extract all relevant data. Studies will be included if they are English language publications that test the association between at least one indicator of childhood socioeconomic position and a leisure-time physical activity outcome measured during adulthood. Any disagreements and discrepancies arising during the conduct of the study will be resolved through discussion. This study will address the gap in evidence by systematically reviewing the published literature to establish whether childhood socioeconomic position is related to adult participation in leisure-time physical activity. The findings may be used to inform future research and policy. PROSPERO CRD42014007063.

Testing the efficacy of a brief sexual risk reduction intervention among high-risk American Indian adults: study protocol for a randomized controlled trial.

PubMed

Chambers, Rachel; Tingey, Lauren; Beach, Anna; Barlow, Allison; Rompalo, Anne

2016-04-29

American Indian adults are more likely to experience co-occurring mental health and substance use disorders than adults of other racial/ethnic groups and are disproportionately burdened by the most common sexually transmitted infections, namely chlamydia and gonorrhea. Several behavioral interventions are proven efficacious in lowering risk for sexually transmitted infection in various populations and, if adapted to address barriers experienced by American Indian adults who suffer from mental health and substance use problems, may be useful for dissemination in American Indian communities. The proposed study aims to examine the efficacy of an adapted evidence-based intervention to increase condom use and decrease sexual risk-taking and substance use among American Indian adults living in a reservation-based community in the Southwestern United States. The proposed study is a randomized controlled trial to test the efficacy of an adapted evidence-based intervention compared to a control condition. Participants will be American Indian adults ages 18-49 years old who had a recent episode of binge substance use and/or suicide ideation. Participants will be randomized to the intervention, a two-session risk-reduction counseling intervention or the control condition, optimized standard care. All participants will be offered a self-administered sexually transmitted infection test. Participants will complete assessments at baseline, 3 and 6 months follow-up. The primary outcome measure is condom use at last sex. This is one of the first randomized controlled trials to assess the efficacy of an adapted evidence-based intervention for reducing sexual risk behaviors among AI adults with substance use and mental health problems. If proven successful, there will be an efficacious program for reducing risk behaviors among high-risk adults that can be disseminated in American Indian communities as well as other rural and under-resourced health systems. Clinical Trials NCT02513225.

Study protocol: the effects of air pollution exposure and chronic respiratory disease on pneumonia risk in urban Malawian adults--the Acute Infection of the Respiratory Tract Study (The AIR Study).

PubMed

Jary, Hannah; Mallewa, Jane; Nyirenda, Mulinda; Faragher, Brian; Heyderman, Robert; Peterson, Ingrid; Gordon, Stephen; Mortimer, Kevin

2015-08-20

Pneumonia is the 2nd leading cause of years of life lost worldwide and is a common cause of adult admissions to hospital in sub-Saharan Africa. Risk factors for adult pneumonia are well characterised in developed countries, but are less well described in sub-Saharan Africa where HIV is a major contributing factor. Exposure to indoor and outdoor air pollution is high, and tobacco smoking prevalence is increasing in sub-Saharan Africa, yet the contribution of these factors to the burden of chronic respiratory diseases in sub-Saharan Africa remains poorly understood. Furthermore, the extent to which the presence of chronic respiratory diseases and exposure to air pollution contribute to the burden of pneumonia is not known. The Acute Infection of the Respiratory Tract Study (The AIR Study) is a case-control study to identify preventable risk factors for adult pneumonia in the city of Blantyre, Malawi. Cases will be adults admitted with pneumonia, recruited from Queen Elizabeth Central Hospital, the largest teaching hospital in Malawi. Controls will be adults without pneumonia, recruited from the community. The AIR Study will recruit subjects and analyse data within strata defined by positive and negative HIV infection status. All participants will undergo thorough assessment for a range of potential preventable risk factors, with an emphasis on exposure to air pollution and the presence of chronic respiratory diseases. This will include collection of questionnaire data, clinical samples (blood, urine, sputum and breath samples), lung function data and air pollution monitoring in their home. Multivariate analysis will be used to identify the important risk factors contributing to the pneumonia burden in this setting. Identification of preventable risk factors will justify research into the effectiveness of targeted interventions to address this burden in the future. The AIR Study is the first study of radiologically confirmed pneumonia in which air pollution exposure

Effectiveness of knowledge translation tools addressing multiple high-burden chronic diseases affecting older adults: protocol for a systematic review alongside a realist review

PubMed Central

Kastner, Monika; Perrier, Laure; Hamid, Jemila; Tricco, Andrea C; Cardoso, Roberta; Ivers, Noah M; Liu, Barbara; Marr, Sharon; Holroyd-Leduc, Jayna; Wong, Geoff; Graves, Lisa; Straus, Sharon E

2015-01-01

Introduction The burden of chronic disease is a global phenomenon, particularly among people aged 65 years and older. More than half of older adults have more than one chronic disease and their care is not optimal. Chronic disease management (CDM) tools have the potential to meet this challenge but they are primarily focused on a single disease, which fails to address the growing number of seniors with multiple chronic conditions. Methods and analysis We will conduct a systematic review alongside a realist review to identify effective CDM tools that integrate one or more high-burden chronic diseases affecting older adults and to better understand for whom, under what circumstances, how and why they produce their outcomes. We will search MEDLINE, EMBASE, CINAHL, AgeLine and the Cochrane Library for experimental, quasi-experimental, observational and qualitative studies in any language investigating CDM tools that facilitate optimal disease management in one or more high-burden chronic diseases affecting adults aged ≥65 years. Study selection will involve calibration of reviewers to ensure reliability of screening and duplicate assessment of articles. Data abstraction and risk of bias assessment will also be performed independently. Analysis will include descriptive summaries of study and appraisal characteristics, effectiveness of each CDM tool (meta-analysis if appropriate); and a realist programme theory will be developed and refined to explain the outcome patterns within the included studies. Ethics and dissemination Ethics approval is not required for this study. We anticipate that our findings, pertaining to gaps in care across high-burden chronic diseases affecting seniors and highlighting specific areas that may require more research, will be of interest to a wide range of knowledge users and stakeholders. We will publish and present our findings widely, and also plan more active dissemination strategies such as workshops with our key stakeholders

Effectiveness of knowledge translation tools addressing multiple high-burden chronic diseases affecting older adults: protocol for a systematic review alongside a realist review.

PubMed

Kastner, Monika; Perrier, Laure; Hamid, Jemila; Tricco, Andrea C; Cardoso, Roberta; Ivers, Noah M; Liu, Barbara; Marr, Sharon; Holroyd-Leduc, Jayna; Wong, Geoff; Graves, Lisa; Straus, Sharon E

2015-02-03

The burden of chronic disease is a global phenomenon, particularly among people aged 65 years and older. More than half of older adults have more than one chronic disease and their care is not optimal. Chronic disease management (CDM) tools have the potential to meet this challenge but they are primarily focused on a single disease, which fails to address the growing number of seniors with multiple chronic conditions. We will conduct a systematic review alongside a realist review to identify effective CDM tools that integrate one or more high-burden chronic diseases affecting older adults and to better understand for whom, under what circumstances, how and why they produce their outcomes. We will search MEDLINE, EMBASE, CINAHL, AgeLine and the Cochrane Library for experimental, quasi-experimental, observational and qualitative studies in any language investigating CDM tools that facilitate optimal disease management in one or more high-burden chronic diseases affecting adults aged ≥65 years. Study selection will involve calibration of reviewers to ensure reliability of screening and duplicate assessment of articles. Data abstraction and risk of bias assessment will also be performed independently. Analysis will include descriptive summaries of study and appraisal characteristics, effectiveness of each CDM tool (meta-analysis if appropriate); and a realist programme theory will be developed and refined to explain the outcome patterns within the included studies. Ethics approval is not required for this study. We anticipate that our findings, pertaining to gaps in care across high-burden chronic diseases affecting seniors and highlighting specific areas that may require more research, will be of interest to a wide range of knowledge users and stakeholders. We will publish and present our findings widely, and also plan more active dissemination strategies such as workshops with our key stakeholders. Our protocol is registered with PROSPERO (registration number

Planned development and evaluation protocol of two versions of a web-based computer-tailored nutrition education intervention aimed at adults, including cognitive and environmental feedback.

PubMed

Springvloet, Linda; Lechner, Lilian; Oenema, Anke

2014-01-17

Despite decades of nutrition education, the prevalence of unhealthy dietary patterns is still high and inequalities in intake between high and low socioeconomic groups still exist. Therefore, it is important to innovate and improve existing nutrition education interventions. This paper describes the development, design and evaluation protocol of a web-based computer-tailored nutrition education intervention for adults targeting fruit, vegetable, high-energy snack and fat intake. This intervention innovates existing computer-tailored interventions by not only targeting motivational factors, but also volitional and self-regulation processes and environmental-level factors. The intervention development was guided by the Intervention Mapping protocol, ensuring a theory-informed and evidence-based intervention. Two versions of the intervention were developed: a basic version targeting knowledge, awareness, attitude, self-efficacy and volitional and self-regulation processes, and a plus version additionally addressing the home environment arrangement and the availability and price of healthy food products in supermarkets. Both versions consist of four modules: one for each dietary behavior, i.e. fruit, vegetables, high-energy snacks and fat. Based on the self-regulation phases, each module is divided into three sessions. In the first session, feedback on dietary behavior is provided to increase awareness, feedback on attitude and self-efficacy is provided and goals and action plans are stated. In the second session goal achievement is evaluated, reasons for failure are explored, coping plans are stated and goals can be adapted. In the third session, participants can again evaluate their behavioral change and tips for maintenance are provided. Both versions will be evaluated in a three-group randomized controlled trial with measurements at baseline, 1-month, 4-months and 9-months post-intervention, using online questionnaires. Both versions will be compared with a generic

The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader-Willi syndrome: study protocol for a randomized controlled trial.

PubMed

Alyousif, Zainab; Miller, Jennifer L; Sandoval, Mariana Y; MacPherson, Chad W; Nagulesapillai, Varuni; Dahl, Wendy J

2018-04-27

Constipation is a frequent problem in adults with Prader-Willi syndrome. Certain probiotics have been shown to improve transit and gastrointestinal symptoms of adults with functional constipation. The aim of this study is to determine the effect of daily consumption of Bifidobacterium animalis ssp. lactis B94 (B. lactis B94) on stool frequency, stool form, and gastrointestinal symptoms in adults with Prader-Willi syndrome. Adults with Prader-Willi syndrome (18-75 years old, n = 36) will be recruited and enrolled in a 20-week, randomized, double-blind, placebo-controlled, crossover study. Study subjects will be randomized to B. lactis B94 or placebo each for a 4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Subjects will complete daily records of stool frequency and stool form (a proxy of transit time). Dietary intake data also will be collected. Stools, one in each period, will be collected for exploratory microbiota analyses. To our knowledge, this is the first randomized controlled trial evaluating the effectiveness of B. lactis in adults with Prader-Willi syndrome. The results of this study will provide evidence of efficacy for future clinical trials in patient populations with constipation. ClinicalTrials.gov ( NCT03277157 ). Registered on 08 September 2017.

Older adult's experience of chronic low back pain and its implications on their daily life: Study protocol of a systematic review of qualitative research.

PubMed

Wong, Arnold Y L; Forss, Katarina Sjögren; Jakobsson, Jenny; Schoeb, Veronika; Kumlien, Christine; Borglin, Gunilla

2018-05-24

Of various chronic diseases, low back pain (LBP) is the most common and debilitating musculoskeletal condition among older adults aged 65 years or older. While more than 17 million older adults in the USA suffer from at least one episode of LBP annually, approximately six million of them experience chronic LBP that significantly affects their quality of life and physical function. Since many older adults with chronic LBP may also have comorbidities and are more sensitive to pain than younger counterparts, these older individuals may face unique age-related physical and psychosocial problems. While some qualitative research studies have investigated the life experiences of older adults with chronic LBP, no systematic review has integrated and synthesized the scientific knowledge regarding the influence of chronic LBP on the physical, psychological, and social aspects of lives in older adults. Without such information, it may result in unmet care needs and ineffective interventions for this vulnerable group. Therefore, the objective of this systematic review is to synthesize knowledge regarding older adults' experiences of living with chronic LBP and the implications on their daily lives. Candidate publications will be sought from databases: PubMed, CINAHL, and PsycINFO. Qualitative research studies will be included if they are related to the experiences of older adults with chronic LBP. Two independent reviewers will screen the titles, abstracts, and full-text articles for eligibility. The reference lists of the included studies will be checked for additional relevant studies. Forward citation tracking will be conducted. Meta-ethnography will be chosen to synthesize the data from the included studies. Specifically, the second-order concepts that are deemed to be translatable by two independent reviewers will be included and synthesized to capture the core of the idiomatic translations (i.e., a translation focusing on salient categories of meaning rather than the

Hodgkin lymphoma in children, adolescents and young adults - a comparative study of clinical presentation and treatment outcome.

PubMed

Englund, Annika; Glimelius, Ingrid; Rostgaard, Klaus; Smedby, Karin E; Eloranta, Sandra; Molin, Daniel; Kuusk, Thomas; Brown, Peter de Nully; Kamper, Peter; Hjalgrim, Henrik; Ljungman, Gustaf; Hjalgrim, Lisa Lyngsie

2018-02-01

Hodgkin lymphoma (HL) treatment protocols for children, adolescents and young adults traditionally differ, but the biological and clinical justification for this remains uncertain. We compared age-dependent clinical presentation and treatment and outcome for 1072 classical HL patients 0-24 years diagnosed in Denmark (1990-2010) and Sweden (1992-2009) in pediatric (n = 315, Denmark <15 years, Sweden <18 years) or adult departments (n = 757). Distribution of clinical characteristics was assessed with Pearson's chi 2 -test and Mantel-Haenszel trend test. The Kaplan-Meier method was used for survival analyses. Hazard ratios (HR) were used to compare the different treatment groups and calculated using Cox regression. Children (0-9 years) less often presented with advanced disease than adolescents (10-17 years) and young adults (18-24 years) (stage IIB-IV: children 32% vs. adolescents 50%, and adults 55%; p < .005). No variation in overall survival (OS) was seen between pediatric and adult departments or by country. Danish pediatric patients received radiotherapy (36%) less frequently than Swedish pediatric patients (71%) (p < .0001). Ten-year event-free survival (EFS) was lower among Danish pediatric patients (0-14 years) (0.79; 95% confidence interval (CI) 0.70-0.86) than among Swedish pediatric patients (0-17 years) (0.88; 95% CI 0.83-0.92), HR (1.93; 95% CI 1.08-3.46). A similar pattern was seen between adult patients in the two countries: Denmark 10-year EFS 0.85 (95% CI 0.81-0.88), Sweden 0.88 (95% CI 0.84-0.91), adjusted HR 1.51 (95% CI 1.03-2.22). Adolescents and young adults shared similar clinical presentation suggesting a rationale of harmonized treatment for these groups. Both adult and pediatric protocols provided high OS with no significant difference between the departments. The less frequent use of radiotherapy in Danish pediatric patients corresponded to a lower EFS, but comparable OS in all groups confirmed effective rescue strategies

Right hemisphere damage: Communication processing in adults evaluated by the Brazilian Protocole MEC – Bateria MAC

PubMed Central

Fonseca, Rochele Paz; Fachel, Jandyra Maria Guimarães; Chaves, Márcia Lorena Fagundes; Liedtke, Francéia Veiga; Parente, Maria Alice de Mattos Pimenta

2007-01-01

Right-brain-damaged individuals may present discursive, pragmatic, lexical-semantic and/or prosodic disorders. Objective To verify the effect of right hemisphere damage on communication processing evaluated by the Brazilian version of the Protocole Montréal d’Évaluation de la Communication (Montreal Communication Evaluation Battery) – Bateria Montreal de Avaliação da Comunicação, Bateria MAC, in Portuguese. Methods A clinical group of 29 right-brain-damaged participants and a control group of 58 non-brain-damaged adults formed the sample. A questionnaire on sociocultural and health aspects, together with the Brazilian MAC Battery was administered. Results Significant differences between the clinical and control groups were observed in the following MAC Battery tasks: conversational discourse, unconstrained, semantic and orthographic verbal fluency, linguistic prosody repetition, emotional prosody comprehension, repetition and production. Moreover, the clinical group was less homogeneous than the control group. Conclusions A right-brain-damage effect was identified directly, on three communication processes: discursive, lexical-semantic and prosodic processes, and indirectly, on pragmatic process. PMID:29213400

Validity of an Exercise Test Based on Habitual Gait Speed in Mobility-Limited Older Adults

PubMed Central

Li, Xin; Forman, Daniel E.; Kiely, Dan K.; LaRose, Sharon; Hirschberg, Ronald; Frontera, Walter R.; Bean, Jonathan F.

2013-01-01

Objective To evaluate whether a customized exercise tolerance testing (ETT) protocol based on an individual’s habitual gait speed (HGS) on level ground would be a valid mode of exercise testing older adults. Although ETT provides a useful means to risk-stratify adults, age-related declines in gait speed paradoxically limit the utility of standard ETT protocols for evaluating older adults. A customized ETT protocol may be a useful alternative to these standard methods, and this study hypothesized that this alternative approach would be valid. Design We performed a cross-sectional analysis of baseline data from a randomized controlled trial of older adults with observed mobility problems. Screening was performed using a treadmill-based ETT protocol customized for each individual’s HGS. We determined the content validity by assessing the results of the ETTs, and we evaluated the construct validity of treadmill time in relation to the Physical Activity Scale for the Elderly (PASE) and the Late Life Function and Disability Instrument (LLFDI). Setting Outpatient rehabilitation center. Participants Community-dwelling, mobility-limited older adults (N = 141). Interventions Not applicable. Main Outcome Measures Cardiac instability, ETT duration, peak heart rate, peak systolic blood pressure, PASE, and LLFDI. Results Acute cardiac instability was identified in 4 of the participants who underwent ETT. The remaining participants (n = 137, 68% female; mean age, 75.3y) were included in the subsequent analyses. Mean exercise duration was 9.39 minutes, with no significant differences in durations being observed after evaluating among tertiles by HGS status. Mean peak heart rate and mean peak systolic blood pressure were 126.6 beats/ min and 175.0mmHg, respectively. Within separate multivariate models, ETT duration in each of the 3 gait speed groups was significantly associated (P<.05) with PASE and LLFDI. Conclusions Mobility-limited older adults can complete this customized

The Hands and Reading: What Deafblind Adult Readers Tell Us

ERIC Educational Resources Information Center

Ingraham, Cynthia L.; Andrews, Jean F.

2010-01-01

Deafblind readers are heterogeneous in reading skill acquisition. This qualitative study uses in-depth interviews and protocol analyses and queries the three deafblind adult participants in describing their metacomprehension, metacognitive and metalinguistic strategies used when reading different types of text. Using retrospective analysis, the…

Understanding the theoretical underpinning of the exercise component in a fall prevention programme for older adults with mild dementia: a realist review protocol.

PubMed

Booth, Vicky; Harwood, Rowan; Hood, Victoria; Masud, Tahir; Logan, Philippa

2016-07-19

Older adults with mild dementia are at an increased risk of falls. Preventing those at risk from falling requires complex interventions involving patient-tailored strength- and balance-challenging exercises, home hazard assessment, visual impairment correction, medical assessment and multifactorial combinations. Evidence for these interventions in older adults with mild cognitive problems is sparse and not as conclusive as the evidence for the general community-dwelling older population. The objectives of this realist review are (i) to identify the underlying programme theory of strength and balance exercise interventions targeted at those individuals that have been identified as falling and who have a mild dementia and (ii) to explore how and why that intervention reduces falls in that population, particularly in the context of a community setting. This protocol will explain the rationale for using a realist review approach and outline the method. A realist review is a methodology that extends the scope of a traditional narrative or systematic evidence review. Increasingly used in the evaluation of complex interventions, a realist enquiry can look at the wider context of the intervention, seeking more to explain than judge if the intervention is effective by investigating why, what the underlying mechanism is and the necessary conditions for success. In this review, key rough programme theories were articulated and defined through discussion with a stakeholder group. The six rough programme theories outlined within this protocol will be tested against the literature found using the described comprehensive search strategy. The process of data extraction, appraisal and synthesis is outlined and will lead to the production of an explanatory programme theory. As far as the authors are aware, this is the first realist literature review within fall prevention research and adds to the growing use of this methodology within healthcare. This synthesis of evidence will

Study protocol for a cluster randomized trial of the Community of Voices choir intervention to promote the health and well-being of diverse older adults.

PubMed

Johnson, Julene K; Nápoles, Anna M; Stewart, Anita L; Max, Wendy B; Santoyo-Olsson, Jasmine; Freyre, Rachel; Allison, Theresa A; Gregorich, Steven E

2015-10-13

Older adults are the fastest growing segment of the United States population. There is an immediate need to identify novel, cost-effective community-based approaches that promote health and well-being for older adults, particularly those from diverse racial/ethnic and socioeconomic backgrounds. Because choral singing is multi-modal (requires cognitive, physical, and psychosocial engagement), it has the potential to improve health outcomes across several dimensions to help older adults remain active and independent. The purpose of this study is to examine the effect of a community choir program (Community of Voices) on health and well-being and to examine its costs and cost-effectiveness in a large sample of diverse, community-dwelling older adults. In this cluster randomized controlled trial, diverse adults age 60 and older were enrolled at Administration on Aging-supported senior centers and completed baseline assessments. The senior centers were randomly assigned to either start the choir immediately (intervention group) or wait 6 months to start (control). Community of Voices is a culturally tailored choir program delivered at the senior centers by professional music conductors that reflects three components of engagement (cognitive, physical, and psychosocial). We describe the nature of the study including the cluster randomized trial study design, sampling frame, sample size calculation, methods of recruitment and assessment, and primary and secondary outcomes. The study involves conducting a randomized trial of an intervention as delivered in "real-world" settings. The choir program was designed using a novel translational approach that integrated evidence-based research on the benefits of singing for older adults, community best practices related to community choirs for older adults, and the perspective of the participating communities. The practicality and relatively low cost of the choir intervention means it can be incorporated into a variety of community

Adolescent to Adult HIV Health Care Transition From the Perspective of Adult Providers in the United States.

PubMed

Tanner, Amanda E; Philbin, Morgan M; Ma, Alice; Chambers, Brittany D; Nichols, Sharon; Lee, Sonia; Fortenberry, J Dennis

2017-10-01

The HIV Care Continuum highlights the need for HIV-infected youth to be tested, linked, and maintained in lifelong care. Care engagement is important for HIV-infected youth in order for them to stay healthy, maintain a low viral load, and reduce further transmission. One point of potential interruption in the care continuum is during health care transition from adolescent- to adult-centered HIV care. HIV-related health care transition research focuses mainly on youth and on adolescent clinic providers; missing is adult clinic providers' perspectives. We examined health care transition processes through semi-structured interviews with 28 adult clinic staff across Adolescent Trials Network sites. We also collected quantitative data related to clinical characteristics and transition-specific strategies. Overall, participants described health care transition as a "warm handoff" and a collaborative effort across adolescent and adult clinics. Emergent transition themes included adult clinical care culture (e.g., patient responsibility), strategies for connecting youth to adult care (e.g., adolescent clinic staff attending youth's first appointment at adult clinic), and approaches to evaluating transition outcomes (e.g., data sharing). Participants provided transition improvement recommendations (e.g., formalized protocols). Using evidence-based research and a quality improvement framework to inform comprehensive and streamlined transition protocols can help enhance the capacity of adult clinics to collaborate with adolescent clinics to provide coordinated and uninterrupted HIV-related care and to improve continuum of care outcomes. Copyright © 2017 Society for Adolescent Health and Medicine. All rights reserved.

The Impact of a Universal Decolonization Protocol on Hospital-Acquired Methicillin-Resistant Staphylococcus aureus in a Burn Population.

PubMed

Johnson, Arthur T; Nygaard, Rachel M; Cohen, Ellie M; Fey, Ryan M; Wagner, Anne Lambert

Hospital-acquired (HA) methicillin-resistant Staphylococcus aureus (MRSA) is a leading cause of HA infections and a significant concern for burn centers. The use of 2% chlorhexidine-impregnated wipes and nasal mupirocin significantly decreases the rate of HA-MRSA in adult intensive care units. The aim of this study was to examine the impact of universal decolonization on the rate of MRSA conversion in an American Burn Association verified adult and pediatric burn center. Universal decolonization protocol consisting of daily chlorhexidine baths and a 5-day course of nasal mupirocin was implemented in the burn unit. MRSA screening both on admission and weekly and contact isolation practices were in place in pre-decolonization and post-decolonization periods. Patient data were analyzed 2 years before and 1 year after implementation of the protocol. The incidence rate of MRSA was significantly decreased after the implementation of the decolonization protocol (11.8 vs 1.0 per 1000 patient days, P < .001). Secondary to the loss of the skin barrier and suppressed immune systems, burn patients are at greater risk for invasive infection leading to severe complications and death. The prevalence of HA-MRSA at our institution's burn center was significantly decreased after the implementation of a universal decolonization protocol.

Testing a Dutch web-based tailored lifestyle programme among adults: a study protocol.

PubMed

Schulz, Daniela N; Kremers, Stef Pj; van Osch, Liesbeth Adm; Schneider, Francine; van Adrichem, Mathieu Jg; de Vries, Hein

2011-02-16

Smoking, high alcohol consumption, unhealthy eating habits and physical inactivity often lead to (chronic) diseases, such as cardiovascular diseases and cancer. Tailored online interventions have been proven to be effective in changing health behaviours. The aim of this study is to test and compare the effectiveness of two different tailoring strategies for changing lifestyle compared to a control group using a multiple health behaviour web-based approach. In our Internet-based tailored programme, the five lifestyle behaviours of smoking, alcohol intake, fruit consumption, vegetable consumption, and physical activity are addressed. This randomized controlled trial, conducted among Dutch adults, includes two experimental groups (i.e., a sequential behaviour tailoring condition and a simultaneous behaviour tailoring condition) and a control group. People in the sequential behaviour tailoring condition obtain feedback on whether their lifestyle behaviours meet the Dutch recommendations. Using a step-by-step approach, they are stimulated to continue with a computer tailored module to change only one unhealthy behaviour first. In the course of the study, they can proceed to change a second behaviour. People in the simultaneous behaviour tailoring condition receive computer tailored feedback about all their unhealthy behaviours during their first visit as a stimulation to change all unhealthy behaviours. The experimental groups can re-visit the website and can then receive ipsative feedback (i.e., current scores are compared to previous scores in order to give feedback about potential changes). The (difference in) effectiveness of the different versions of the programme will be tested and compared to a control group, in which respondents only receive a short health risk appraisal. Programme evaluations will assess satisfaction with and appreciation and personal relevance of the intervention among the respondents. Finally, potential subgroup differences pertaining to

Feasibility randomised controlled trial of Recovery-focused Cognitive Behavioural Therapy for Older Adults with bipolar disorder (RfCBT-OA): study protocol.

PubMed

Tyler, Elizabeth; Lobban, Fiona; Sutton, Chris; Depp, Colin; Johnson, Sheri; Laidlaw, Ken; Jones, Steven H

2016-03-03

Bipolar disorder is a severe and chronic mental health problem that persists into older adulthood. The number of people living with this condition is set to rise as the UK experiences a rapid ageing of its population. To date, there has been very little research or service development with respect to psychological therapies for this group of people. A parallel two-arm randomised controlled trial comparing a 14-session, 6-month Recovery-focused Cognitive-Behavioural Therapy for Older Adults with bipolar disorder (RfCBT-OA) plus treatment as usual (TAU) versus TAU alone. Participants will be recruited in the North-West of England via primary and secondary mental health services and through self-referral. The primary objective of the study is to evaluate the feasibility and acceptability of RfCBT-OA; therefore, a formal power calculation is not appropriate. It has been estimated that randomising 25 participants per group will be sufficient to be able to reliably determine the primary feasibility outcomes (eg, recruitment and retention rates), in line with recommendations for sample sizes for feasibility/pilot trials. Participants in both arms will complete assessments at baseline and then every 3 months, over the 12-month follow-up period. We will gain an estimate of the likely effect size of RfCBT-OA on a range of clinical outcomes and estimate parameters needed to determine the appropriate sample size for a definitive, larger trial to evaluate the effectiveness and cost-effectiveness of RfCBT-OA. Data analysis is discussed further in the Analysis section in the main paper. This protocol was approved by the UK National Health Service (NHS) Ethics Committee process (REC ref: 15/NW/0330). The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and local, participating NHS trusts. ISRCTN13875321; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already

Lessons from Studies to Evaluate an Online 24-Hour Recall for Use with Children and Adults in Canada.

PubMed

Kirkpatrick, Sharon I; Gilsing, Anne M; Hobin, Erin; Solbak, Nathan M; Wallace, Angela; Haines, Jess; Mayhew, Alexandra J; Orr, Sarah K; Raina, Parminder; Robson, Paula J; Sacco, Jocelyn E; Whelan, Heather K

2017-01-31

With technological innovation, comprehensive dietary intake data can be collected in a wide range of studies and settings. The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based system that guides respondents through 24-h recalls. The purpose of this paper is to describe lessons learned from five studies that assessed the feasibility and validity of ASA24 for capturing recall data among several population subgroups in Canada. These studies were conducted within a childcare setting (preschool children with reporting by parents), in public schools (children in grades 5-8; aged 10-13 years), and with community-based samples drawn from existing cohorts of adults and older adults. Themes emerged across studies regarding receptivity to completing ASA24, user experiences with the interface, and practical considerations for different populations. Overall, we found high acceptance of ASA24 among these diverse samples. However, the ASA24 interface was not intuitive for some participants, particularly young children and older adults. As well, technological challenges were encountered. These observations underscore the importance of piloting protocols using online tools, as well as consideration of the potential need for tailored resources to support study participants. Lessons gleaned can inform the effective use of technology-enabled dietary assessment tools in research.

High-throughput imaging of adult fluorescent zebrafish with an LED fluorescence macroscope

PubMed Central

Blackburn, Jessica S; Liu, Sali; Raimondi, Aubrey R; Ignatius, Myron S; Salthouse, Christopher D; Langenau, David M

2011-01-01

Zebrafish are a useful vertebrate model for the study of development, behavior, disease and cancer. A major advantage of zebrafish is that large numbers of animals can be economically used for experimentation; however, high-throughput methods for imaging live adult zebrafish had not been developed. Here, we describe protocols for building a light-emitting diode (LED) fluorescence macroscope and for using it to simultaneously image up to 30 adult animals that transgenically express a fluorescent protein, are transplanted with fluorescently labeled tumor cells or are tagged with fluorescent elastomers. These protocols show that the LED fluorescence macroscope is capable of distinguishing five fluorescent proteins and can image unanesthetized swimming adult zebrafish in multiple fluorescent channels simultaneously. The macroscope can be built and used for imaging within 1 day, whereas creating fluorescently labeled adult zebrafish requires 1 hour to several months, depending on the method chosen. The LED fluorescence macroscope provides a low-cost, high-throughput method to rapidly screen adult fluorescent zebrafish and it will be useful for imaging transgenic animals, screening for tumor engraftment, and tagging individual fish for long-term analysis. PMID:21293462

Design, rationale and feasibility of a multidimensional experimental protocol to study early life stress.

PubMed

Bartholomeusz, M Dillwyn; Bolton, Philip S; Callister, Robin; Skinner, Virginia; Hodgson, Deborah

2017-09-01

There is a rapidly accumulating body of evidence regarding the influential role of early life stress (ELS) upon medical and psychiatric conditions. While self-report instruments, with their intrinsic limitations of recall, remain the primary means of detecting ELS in humans, biological measures are generally limited to a single biological system. This paper describes the design, rationale and feasibility of a study to simultaneously measure neuroendocrine, immune and autonomic nervous system (ANS) responses to psychological and physiological stressors in relation to ELS. Five healthy university students were recruited by advertisement. Exclusion criteria included chronic medical conditions, psychotic disorders, needle phobia, inability to tolerate pain, and those using anti-inflammatory medications. They were clinically interviewed and physiological recordings made over a two-hour period pre, during and post two acute stressors: the cold pressor test and recalling a distressing memory. The Childhood Trauma Questionnaire and the Parental Bonding Index were utilised to measure ELS. Other psychological measures of mood and personality were also administered. Measurements of heart rate, blood pressure, respiratory rate, skin conductance, skin blood flow and temporal plasma samples were successfully obtained before, during and after acute stress. Participants reported the extensive psychological and multisystem physiological data collection and stress provocations were tolerable. Most (4/5) participants indicated a willingness to return to repeat the protocol, indicating acceptability. Our protocol is viable and safe in young physically healthy adults and allows us to assess simultaneously neuroendocrine, immune and autonomic nervous system responses to stressors in persons assessed for ELS.

Dehydration and clearing of adult Drosophila for ultramicroscopy.

PubMed

Becker, Klaus; Jährling, Nina; Saghafi, Saiedeh; Dodt, Hans-Ulrich

2013-07-01

This protocol describes the preparation of adult flies for ultramicroscopy (UM), a powerful imaging technique that achieves precise and accurate three-dimensional (3D) reconstructions of intact macroscopic specimens with micrometer resolution. In UM, a specimen in the size range of ∼1-15 mm is illuminated perpendicular to the observation pathway by two thin counterpropagating sheets of laser light. Thus, specimens for UM need to be sufficiently transparent, which requires chemical clearing in most cases. In this protocol, Drosophila melanogaster adults are fixed, dehydrated in ethanol, and then cleared in a solution of benzyl alcohol and benzyl benzoate.

Major Electrocardiographic Abnormalities According to the Minnesota Coding System Among Brazilian Adults (from the ELSA-Brasil Cohort Study).

PubMed

Pinto-Filho, Marcelo M; Brant, Luisa C C; Foppa, Murilo; Garcia-Silva, Kaiser B; Mendes de Oliveira, Rackel Aguiar; de Jesus Mendes da Fonseca, Maria; Alvim, Sheila; Lotufo, Paulo A; Mill, José G; Barreto, Sandhi M; Macfarlane, Peter W; Ribeiro, Antonio L P

2017-06-15

The electrocardiogram is a simple and useful clinical tool; nevertheless, few studies have evaluated the prevalence of electrocardiographic abnormalities in the Latin American population. This study aims to evaluate the major electrocardiographic abnormalities according to the Minnesota coding system in Brazilian adults, stratified by gender, age, race, and cardiovascular risk factors. Data from 14,424 adults (45.8% men, age 35 to 74 years) were obtained at baseline of the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil), according to standardized protocol. The electrocardiogram were obtained with the Burdick Atria 6100 machine, stored on Pyramis System, automatically coded according to the Minnesota coding system by the Glasgow University software and then manually revised. Major abnormalities were more prevalent in men than women (11.3% and 7.9%, p <0.001). These differences were consistent through the different age groups, race, and number of cardiovascular risk factors. Electrocardiographic major abnormalities were more prevalent in black participants for both men (black: 15.1%, mixed: 10.4%, white: 11.1%, p = 0.001) and women (black: 10%, mixed: 7.6%, white: 7.2%, p = 0.004). In conclusion, in this large sample of Brazilian adults, the prevalence of major electrocardiographic abnormalities was higher among men, the elderly, black, and among people with more cardiovascular risk factors. Copyright © 2017 Elsevier Inc. All rights reserved.

A systematic review of risk factors associated with accidental falls, outcome measures and interventions to manage fall risk in non-ambulatory adults.

PubMed

Rice, Laura A; Ousley, Cherita; Sosnoff, Jacob J

2015-01-01

To systematically review peer-reviewed literature pertaining to risk factors, outcome measures and interventions managing fall risk in non-ambulatory adults. Twenty-one papers were selected for inclusion from databases including PubMed/Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library, Scopus, Consumer Health Complete and Web of Science. Selected studies involved a description of fall related risk factors, outcomes to assess fall risk and intervention studies describing protocols to manage fall risk in non-ambulatory adults. Studies were selected by two reviewers and consultation provided by a third reviewer. The most frequently cited risk factors/characteristics associated with falls included: wheelchair related characteristics, transfer activities, impaired seated balance and environmental factors. The majority of the outcomes were found to evaluate seated postural control. One intervention study was identified describing a protocol targeting specific problems of individual participants. A global fall prevention program was not identified. Several risk factors associated with falls were identified and must be understood by clinicians to better serve their clients. To improve objective assessment, a comprehensive outcome assessment specific to non-ambulatory adults is needed. Finally, additional research is needed to examine the impact of structured protocols to manage fall risk in non-ambulatory adults. Falls are a common health concern for non-ambulatory adults. Risk factors commonly associated with falls include wheelchair related characteristics, transfer activities, impaired seated balance and environmental factors. Limited outcome measures are available to assess fall risk in non-ambulatory adults. Clinicians must be aware of the known risk factors and provide comprehensive education to their clients on the potential for falls. Additional research is needed to develop and evaluate protocols to clinically manage fall

The effects of a mindfulness-based lifestyle programme for adults with Parkinson's disease: protocol for a mixed methods, randomised two-group control study.

PubMed

Advocat, Jenny; Russell, Grant; Enticott, Joanne; Hassed, Craig; Hester, Jennifer; Vandenberg, Brooke

2013-10-10

Parkinson's disease (PD) is the second most common neurodegenerative disorder in developed countries. There is an increasing interest in the use of mindfulness-related interventions in the management of patients with a chronic disease. In addition, interventions that promote personal control, stress-management and other lifestyle factors, such as diet and exercise, assist in reducing disability and improving quality of life in people with chronic illnesses. There has been little research in this area for people with PD. A prospective mixed-method randomised clinical trial involving community living adults with PD aged <76 years and with moderate disease severity (Hoehn and Yahr stage 2) PD. Participants will be randomised into the ESSENCE 6-week programme or a matched wait list control group. ESSENCE is a multifaceted, healthy lifestyle and mindfulness programme designed to improve quality of life. We aim to determine whether participation in a mindfulness and lifestyle programme could improve PD-related function and explore self-management related experiences and changing attitudes towards self-management. The outcome measures will include 5 self-administered questionnaires: PD function and well-being questionnaire (PDQ39), Health Behaviours, Mental health, Multidimensional locus of control, and Freiburg mindfulness inventory. An embedded qualitative protocol will include in-depth interviews with 12 participants before and after participation in the 6-week programme and a researcher will observe the programme and take notes. Repeated measures of Analysis of Variance (ANOVA) will examine the outcome measures for any significant effects from the group allocation, age, sex, adherence score and attendance. Qualitative data will be analysed thematically. We will outline the benefits of, and barriers to, the uptake of the intervention. This protocol has received ethics approval from the Monash University Human Research Ethics Committee project number CF11

Accelerating Pediatric Cancer Drug Development: Challenges and Opportunities for Pediatric Master Protocols.

PubMed

Khan, Tahira; Stewart, Mark; Blackman, Samuel; Rousseau, Raphaël; Donoghue, Martha; Cohen, Kenneth; Seibel, Nita; Fleury, Mark; Benettaib, Bouchra; Malik, Raleigh; Vassal, Gilles; Reaman, Gregory

2018-01-01

Although outcomes for children with cancer have significantly improved over the past 40 years, there has been little progress in the treatment of some pediatric cancers, particularly when advanced. Additionally, clinical trial options and availability are often insufficient. Improved genomic and immunologic understanding of pediatric cancers, combined with innovative clinical trial designs, may provide an enhanced opportunity to study childhood cancers. Master protocols, which incorporate the use of precision medicine approaches, coupled with the ability to quickly assess the safety and effectiveness of new therapies, have the potential to accelerate early-phase clinical testing of novel therapeutics and which may result in more rapid approval of new drugs for children with cancer. Designing and conducting master protocols for children requires addressing similar principles and requirements as traditional adult oncology trials, but there are also unique considerations for master protocols conducted in children with cancer. The purpose of this paper is to define the key challenges and opportunities associated with this approach in order to ensure that master protocols can be adapted to benefit children and adolescents and ensure that adequate data are captured to advance, in parallel, the clinical development of investigational agents for children with cancer.

Protocol for determining bull trout presence

USGS Publications Warehouse

Peterson, James; Dunham, Jason B.; Howell, Philip; Thurow, Russell; Bonar, Scott

2002-01-01

The Western Division of the American Fisheries Society was requested to develop protocols for determining presence/absence and potential habitat suitability for bull trout. The general approach adopted is similar to the process for the marbled murrelet, whereby interim guidelines are initially used, and the protocols are subsequently refined as data are collected. Current data were considered inadequate to precisely identify suitable habitat but could be useful in stratifying sampling units for presence/absence surveys. The presence/absence protocol builds on previous approaches (Hillman and Platts 1993; Bonar et al. 1997), except it uses the variation in observed bull trout densities instead of a minimum threshold density and adjusts for measured differences in sampling efficiency due to gear types and habitat characteristics. The protocol consists of: 1. recommended sample sizes with 80% and 95% detection probabilities for juvenile and resident adult bull trout for day and night snorkeling and electrofishing adjusted for varying habitat characteristics for 50m and 100m sampling units, 2. sampling design considerations, including possible habitat characteristics for stratification, 3. habitat variables to be measured in the sampling units, and 3. guidelines for training sampling crews. Criteria for habitat strata consist of coarse, watershed-scale characteristics (e.g., mean annual air temperature) and fine-scale, reach and habitat-specific features (e.g., water temperature, channel width). The protocols will be revised in the future using data from ongoing presence/absence surveys, additional research on sampling efficiencies, and development of models of habitat/species occurrence.

Guided internet-administered self-help to reduce symptoms of anxiety and depression among adolescents and young adults diagnosed with cancer during adolescence (U-CARE: YoungCan): a study protocol for a feasibility trial.

PubMed

Ander, Malin; Wikman, Anna; Ljótsson, Brjánn; Grönqvist, Helena; Ljungman, Gustaf; Woodford, Joanne; Lindahl Norberg, Annika; von Essen, Louise

2017-01-27

A subgroup of adolescents and young adults diagnosed with cancer during adolescence reports elevated levels of anxiety and depressive symptoms and unmet needs for psychological support. Evidence-based psychological treatments tailored for this population are lacking. This protocol describes a feasibility study of a guided-internet-administered self-help programme (YoungCan) primarily targeting symptoms of anxiety and depression among young persons diagnosed with cancer during adolescence and of the planned study procedures for a future controlled trial. The study is an uncontrolled feasibility trial with a pre-post and 3-month follow-up design. Potential participants aged 15-25 years, diagnosed with cancer during adolescence, will be identified via the Swedish Childhood Cancer Registry. 30 participants will be included. Participants will receive YoungCan, a 12-week therapist-guided, internet-administered self-help programme consisting primarily of cognitive-behavioural therapy organised into individually assigned modules targeting depressive symptoms, worry and anxiety, body dissatisfaction and post-traumatic stress. Interactive peer support and psychoeducative functions are also available. Feasibility outcomes include: recruitment and eligibility criteria; data collection; attrition; resources needed to complete the study and programme; safety procedures; participants' and therapists' adherence to the programme; and participants' acceptability of the programme and study methodology. Additionally, mechanisms of impact will be explored and data regarding symptoms of anxiety, depression, post-traumatic stress, body dissatisfaction, reactions to social interactions, quality of life, axis I diagnoses according to the Mini International Neuropsychiatric Interview and healthcare service use will be collected. Exploratory analyses of changes in targeted outcomes will be conducted. This feasibility protocol was approved by the Regional Ethical Review Board in Uppsala

Computer classes and games in virtual reality environment to reduce loneliness among students of an elderly reference center: Study protocol for a randomised cross-over design.

PubMed

Antunes, Thaiany Pedrozo Campos; Oliveira, Acary Souza Bulle de; Crocetta, Tania Brusque; Antão, Jennifer Yohanna Ferreira de Lima; Barbosa, Renata Thais de Almeida; Guarnieri, Regiani; Massetti, Thais; Monteiro, Carlos Bandeira de Mello; Abreu, Luiz Carlos de

2017-03-01

Physical and mental changes associated with aging commonly lead to a decrease in communication capacity, reducing social interactions and increasing loneliness. Computer classes for older adults make significant contributions to social and cognitive aspects of aging. Games in a virtual reality (VR) environment stimulate the practice of communicative and cognitive skills and might also bring benefits to older adults. Furthermore, it might help to initiate their contact to the modern technology. The purpose of this study protocol is to evaluate the effects of practicing VR games during computer classes on the level of loneliness of students of an elderly reference center. This study will be a prospective longitudinal study with a randomised cross-over design, with subjects aged 50 years and older, of both genders, spontaneously enrolled in computer classes for beginners. Data collection will be done in 3 moments: moment 0 (T0) - at baseline; moment 1 (T1) - after 8 typical computer classes; and moment 2 (T2) - after 8 computer classes which include 15 minutes for practicing games in VR environment. A characterization questionnaire, the short version of the Short Social and Emotional Loneliness Scale for Adults (SELSA-S) and 3 games with VR (Random, MoviLetrando, and Reaction Time) will be used. For the intervention phase 4 other games will be used: Coincident Timing, Motor Skill Analyser, Labyrinth, and Fitts. The statistical analysis will compare the evolution in loneliness perception, performance, and reaction time during the practice of the games between the 3 moments of data collection. Performance and reaction time during the practice of the games will also be correlated to the loneliness perception. The protocol is approved by the host institution's ethics committee under the number 52305215.3.0000.0082. Results will be disseminated via peer-reviewed journal articles and conferences. This clinical trial is registered at ClinicalTrials.gov identifier: NCT

Participation in Pediatric Oncology Research Protocols: Racial/ethnic, Language and Age-based Disparities

PubMed Central

Aristizabal, Paula; Singer, Jenelle; Cooper, Renee; Wells, Kristen J.; Nodora, Jesse; Milburn, Mehrzad; Gahagan, Sheila; Schiff, Deborah E.; Martinez, Maria Elena

2015-01-01

Background Survival rates in pediatric oncology have improved dramatically, in part due to high patient participation in clinical trials. Although racial/ethnic inequalities in clinical trial participation have been reported in adults, pediatric data and studies comparing participation rates by socio-demographic characteristics are scarce. The goal of this study was to assess differences in research protocol participation for childhood cancer by age, sex, race/ethnicity, parental language, cancer type and insurance status. Procedure Data on enrollment in any protocol, biospecimen, or therapeutic protocols were collected and analyzed for newly diagnosed pediatric patients with cancer from 2008–2012 at Rady Children’s Hospital. Results Among the 353 patients included in the analysis, 304 (86.1%) were enrolled in any protocol. Enrollment in biospecimen and therapeutic protocols was 84.2% (261/310) and 81.1% (206/254), respectively. Logistic regression analyses revealed significant enrollment underrepresentation in any protocol for Hispanics compared to Non-Hispanic whites (81% vs. 91%; Odds Ratio [OR], 0.43; 95% Confidence Interval [CI], 0.21–0.90; p=0.021) and among children of Spanish-speaking vs. English-speaking parents (78% vs. 89%; OR, 0.45; 95%CI, 0.23–0.87; p=0.016). Compared to patients aged 0–4 years, significant underrepresentation was also found among patients 15–21 years old (92% vs.72%; OR, 0.21; 95% CI, 0.09–0.48; p<0.001). Similar trends were observed when analyzing enrollment in biospecimen and therapeutic protocols separately. Conclusions There was significant underrepresentation in protocol participation for Hispanics, children of Spanish-speaking parents, and patients ages 15–21. Research is urgently needed to understand barriers to research participation among these groups underrepresented in pediatric oncology clinical trials. PMID:25755225

An Individualized, Perception-Based Protocol to Investigate Human Physiological Responses to Cooling

PubMed Central

Coolbaugh, Crystal L.; Bush, Emily C.; Galenti, Elizabeth S.; Welch, E. Brian; Towse, Theodore F.

2018-01-01

Cold exposure, a known stimulant of the thermogenic effects of brown adipose tissue (BAT), is the most widely used method to study BAT physiology in adult humans. Recently, individualized cooling has been recommended to standardize the physiological cold stress applied across participants, but critical experimental details remain unclear. The purpose of this work was to develop a detailed methodology for an individualized, perception-based protocol to investigate human physiological responses to cooling. Participants were wrapped in two water-circulating blankets and fitted with skin temperature probes to estimate BAT activity and peripheral vasoconstriction. We created a thermoesthesia graphical user interface (tGUI) to continuously record the subject's perception of cooling and shivering status during the cooling protocol. The protocol began with a 15 min thermoneutral phase followed by a series of 10 min cooling phases and concluded when sustained shivering (>1 min duration) occurred. Researchers used perception of cooling feedback (tGUI ratings) to manually adjust and personalize the water temperature at each cooling phase. Blanket water temperatures were recorded continuously during the protocol. Twelve volunteers (ages: 26.2 ± 1.4 years; 25% female) completed a feasibility study to evaluate the proposed protocol. Water temperature, perception of cooling, and shivering varied considerably across participants in response to cooling. Mean clavicle skin temperature, a surrogate measure of BAT activity, decreased (−0.99°C, 95% CI: −1.7 to −0.25°C, P = 0.16) after the cooling protocol, but an increase in supraclavicular skin temperature was observed in 4 participants. A strong positive correlation was also found between thermoesthesia and peripheral vasoconstriction (ρ = 0.84, P < 0.001). The proposed individualized, perception-based protocol therefore has potential to investigate the physiological responses to cold stress applied across populations with

Where Adults Go: A Multiple Case Study of Adult Serving Undergraduate Colleges and Universities

ERIC Educational Resources Information Center

Dixon-Williams, Shelley B.

2010-01-01

This research is an exploratory multiple case study of adult serving undergraduate colleges and universities. Using the Council of Adult and Experiential Learning (CAEL) Principles of Effective Practice for Serving Adult Learners, this study examines the differences of adult serving undergraduate colleges across the three sectors of higher…

Issues in conducting cross-cultural research: implementation of an agreed international protocol [corrected] designed by the WHOQOL Group for the conduct of focus groups eliciting the quality of life of older adults.

PubMed

Hawthorne, Graeme; Davidson, Natasha; Quinn, Kathryn; McCrate, Farah; Winkler, Ines; Lucas, Ramona; Kilian, Reinhold; Molzahn, Anita

2006-09-01

Multi-centre and cross-cultural research require the use of common protocols if the results are to be either pooled or compared. All too often adherence to protocols is not discussed in reports and where it is reported poor adherence is frequently noted. This paper discusses the use of international guidelines developed by WHOQOL Field Centres to conduct and report focus groups aimed at eliciting key concepts of quality of life among older adults. This was the first step in the development of the WHOQOL-OLD instrument. Although there was overall adherence to the agreed guidelines, there were some differences in the level of reporting, even after participating Field Centres had the opportunity to explain their reports. The reasons for these discrepancies are reported. It is concluded that because of local situations, it is difficult to achieve identical implementation of multi-centre cross-cultural protocols and that the highest standards of auditing are required if findings are to be compared. Suggestions for how such protocols can be improved are given.

GABA and primary motor cortex inhibition in young and older adults: a multimodal reliability study.

PubMed

Mooney, Ronan A; Cirillo, John; Byblow, Winston D

2017-07-01

The effects of healthy aging on γ-aminobutyric acid (GABA) within primary motor cortex (M1) remain poorly understood. Studies have reported contrasting results, potentially due to limitations with the common assessment technique. The aim of the present study was to investigate the effect of healthy aging on M1 GABA concentration and neurotransmission using a multimodal approach. Fifteen young and sixteen older adults participated in this study. Magnetic resonance spectroscopy (MRS) was used to measure M1 GABA concentration. Single-pulse and threshold-tracking paired-pulse transcranial magnetic stimulation (TMS) protocols were used to examine cortical silent period duration, short- and long-interval intracortical inhibition (SICI and LICI), and late cortical disinhibition (LCD). The reliability of TMS measures was examined with intraclass correlation coefficient analyses. SICI at 1 ms was reduced in older adults (15.13 ± 2.59%) compared with young (25.66 ± 1.44%; P = 0.002). However, there was no age-related effect for cortical silent period duration, SICI at 3 ms, LICI, or LCD (all P > 0.66). The intersession reliability of threshold-tracking measures was good to excellent for both young (range 0.75-0.96) and older adults (range 0.88-0.93). Our findings indicate that extrasynaptic inhibition may be reduced with advancing age, whereas GABA concentration and synaptic inhibition are maintained. Furthermore, MRS and threshold-tracking TMS provide valid and reliable assessment of M1 GABA concentration and neurotransmission, respectively, in young and older adults. NEW & NOTEWORTHY γ-Aminobutyric acid (GABA) in primary motor cortex was assessed in young and older adults using magnetic resonance spectroscopy and threshold-tracking paired-pulse transcranial magnetic stimulation. Older adults exhibited reduced extrasynaptic inhibition (short-interval intracortical inhibition at 1 ms) compared with young, whereas GABA concentration and synaptic inhibition were

Natural history of dental plaque accumulation in mechanically ventilated adults: a descriptive correlational study.

PubMed

Jones, Deborah J; Munro, Cindy L; Grap, Mary Jo

2011-12-01

The purpose of this study was to describe the pattern of dental plaque accumulation in mechanically ventilated adults. Accumulation of dental plaque and bacterial colonisation of the oropharynx is associated with a number of systemic diseases including ventilator associated pneumonia. Data were collected from mechanically ventilated critically ill adults (n=137), enrolled within 24 hours of intubation. Dental plaque, counts of decayed, missing and filled teeth and systemic antibiotic use was assessed on study days 1, 3, 5 and 7. Dental plaque averages per study day, tooth type and tooth location were analysed. Medical respiratory, surgical trauma and neuroscience ICU's of a large tertiary care centre in the southeast United States. Plaque: all surfaces >60% plaque coverage from day 1 to day 7; molars and premolars contained greatest plaque average >70%. Systemic antibiotic use on day 1 had no significant effect on plaque accumulation on day 3 (p=0.73). Patients arrive in critical care units with preexisting oral hygiene issues. Dental plaque tends to accumulate in the posterior teeth (molars and premolars) that may be hard for nurses to visualise and reach; this problem may be exacerbated by endotracheal tubes and other equipment. Knowing accumulation trends of plaque will guide the development of effective oral care protocols. Published by Elsevier Ltd.

Examining the stability of dual-task posture and reaction time measures in older adults over five sessions: a pilot study.

PubMed

Jehu, Deborah A; Paquet, Nicole; Lajoie, Yves

2016-12-01

Improved performance may be inherent due to repeated exposure to a testing protocol. However, limited research has examined this phenomenon in postural control. The aim was to determine the influence of repeated administration of a dual-task testing protocol once per week for 5 weeks on postural sway and reaction time. Ten healthy older adults (67.0 ± 6.9 years) stood on a force plate for 30 s in feet apart and semi-tandem positions while completing simple reaction time (SRT) and choice reaction time (CRT) tasks. They were instructed to stand as still as possible while verbally responding as fast as possible to the stimuli. No significant differences in postural sway were shown over time (p > 0.05). A plateau in average CRT emerged as the time effect revealed longer CRT during session 1 compared to sessions 3-5 (p < 0.05). Furthermore, the time effect for within-subject variability of CRT uncovered no plateaus as it was less variable in session 5 than sessions 1-4 (p < 0.05). The lack of a plateau in variability of CRT may have emerged as older adults may require longer to reach optimal performance potential in a dual-task context. Postural sway and SRT were stable over the 5 testing sessions, but variability of CRT continued to improve over time. These findings form a basis for future studies to examine performance-related improvements due to repeated exposure to a testing protocol in a dual-task setting.

Cryopreservation of adult cervid testes.

PubMed

Pothana, Lavanya; Devi, Lalitha; Goel, Sandeep

2017-02-01

Several species of cervids are currently classified as threatened or endangered due to a rapid decline in their populations. Sperm cryopreservation, in association with assisted reproductive technologies, can find application for the conservation of endangered cervids. In cases of unsuccessful sperm retrieval through other means prior to the death of the animal, adult testis is the only source of sperm. Recovery of viable sperm from adult testes depends on the effective preservation of testicular tissues through optimization of cryopreservation protocols. The present study evaluated combinations of 10% dimethyl sulfoxide (DMSO) with 0% or 80% fetal bovine serum (FBS) and 20% DMSO with 0 or 20% FBS for the cryopreservation of testicular tissues of three adult cervids using uncontrolled slow freezing protocol. The cryopreserved testis was compared to chilled tissue without cryoprotectants. Results revealed that testicular tissues of barking deer cryopreserved in 20% DMSO (D20) had all the analyzed 7 parameters (number of TNP1-, PRM2 and acrosin-expressing cells/tubule and, the number of viable, morphologically normal, acrosome intact, Annexin V-negative sperm) comparable to the chilled testis. However, testicular tissues of sambhar and hog deer cryopreserved only in D20S20 had 5 of 7 parameters comparable to the chilled testis. In conclusion, D20 is acceptable for cryopreservation of barking deer and D20S20 for sambar and hog deer testes. Copyright © 2016 Elsevier Inc. All rights reserved.

A modified Mediterranean dietary intervention for adults with major depression: Dietary protocol and feasibility data from the SMILES trial.

PubMed

Opie, Rachelle S; O'Neil, Adrienne; Jacka, Felice N; Pizzinga, Josephine; Itsiopoulos, Catherine

2017-04-19

The SMILES trial was the first randomized controlled trial (RCT) explicitly designed to evaluate a dietary intervention, conducted by qualified dietitians, for reducing depressive symptomatology in adults with clinical depression. Here we detail the development of the prescribed diet (modified Mediterranean diet (ModiMedDiet)) for individuals with major depressive disorders (MDDs) that was designed specifically for the SMILES trial. We also present data demonstrating the extent to which this intervention achieved improvements in diet quality. The ModiMedDiet was designed using a combination of existing dietary guidelines and scientific evidence from the emerging field of nutritional psychiatric epidemiology. Sixty-seven community dwelling individuals (Melbourne, Australia) aged 18 years or over, with current poor quality diets, and MDDs were enrolled into the SMILES trial. A retention rate of 93.9 and 73.5% was observed for the dietary intervention and social support control group, respectively. The dietary intervention (ModiMedDiet) consisted of seven individual nutrition counselling sessions delivered by a qualified dietitian. The control condition comprised a social support protocol matched to the same visit schedule and length. This manuscript details the first prescriptive individualized dietary intervention delivered by dietitians for adults with major depression. Significant improvements in dietary quality were observed among individuals randomized to the ModiMedDiet group. These dietary improvements were also found to be associated with changes in depressive symptoms. The ModiMedDiet, a novel and individually tailored intervention designed specifically for adults with major depression, can be effectively implemented in clinical practice to manage this highly prevalent and debilitating condition. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820. Registered 29 February 2012.

An Italian multicentre study on adult atopic dermatitis: persistent versus adult-onset disease.

PubMed

Megna, Matteo; Patruno, Cataldo; Balato, Anna; Rongioletti, Franco; Stingeni, Luca; Balato, Nicola

2017-08-01

Atopic dermatitis (AD) is a chronic, recurrent, inflammatory skin disease which predominantly affects children. However, AD may persist until adulthood (persistent AD), or directly start in adults (adult-onset AD). AD often shows a non-flexural rash distribution, and atypical morphologic variants in adults and specific diagnostic criteria are lacking. Moreover, adult AD prevalence as well as detailed data which can characterize persistent vs adult-onset subtype are scant. The aim of this study was to investigate on the main features of adult AD particularly highlighting differences between persistent vs adult-onset form. An Italian multicentre observational study was conducted between April 2015-July 2016 through a study-specific digital database. 253 adult AD patients were enrolled. Familiar history of AD was negative in 81.0%. Erythemato-desquamative pattern was the most frequent clinical presentation (74.3%). Flexural surface of upper limbs was most commonly involved (47.8%), followed by eyelid/periocular area (37.9%), hands (37.2%), and neck (32%). Hypertension (7.1%) and thyroiditis (4.3%) were the most frequent comorbidities. A subgroup analysis between persistent (59.7%) vs adult-onset AD patients (40.3%) showed significant results only regarding AD severity (severe disease was more common in persistent group, p < 0.05), itch intensity (higher in adult-onset disease), and comorbidities (hypertension was more frequent in adult-onset group, p < 0.01). Adult AD showed uncommon features such as significant association with negative AD family history and lacking of association with systemic comorbidities respect to general population. No significant differences among persistent vs adult-onset subgroup were registered except for hypertension, itch intensity, and disease severity.

Interview Schedule for Studying Why Adults Learn.

ERIC Educational Resources Information Center

Tough, Allen

Designed for use in a 1968 study of why adults learn, this interview schedule contains situation-description and question sheets for use by the interviewer and subject for examining thirteen reasons why adults begin and why they continue a learning project. (The study, "Why Adults Learn: A Study of the Major Reasons for Beginning and Continuing a…

An improved pyrite pretreatment protocol for kinetic and isotopic studies

NASA Astrophysics Data System (ADS)

Mirzoyan, Natella; Kamyshny, Alexey; Halevy, Itay

2014-05-01

An improved pyrite pretreatment protocol for kinetic and isotopic studies Natella Mirzoyan1, Alexey Kamyshny Jr.2, Itay Halevy1 1Earth and Planetary Sciences, Weizmann Institute of Science, Rehovot 76100, Israel 2Geological and Environmental Sciences, Ben-Gurion University of the Negev, Beer Sheva 84105, Israel Pyrite is one of the most abundant and widespread of the sulfide minerals with a central role in biogeochemical cycles of iron and sulfur. Due to its diverse roles in the natural and anthropogenic sulfur cycle, pyrite has been extensively studied in various experimental investigations of the kinetics of its dissolution and oxidation, the isotopic fractionations associated with these reactions, and the microbiological processes involved. Pretreatment of pyrite for removal of oxidation impurities to prevent experimental artifacts and inaccuracies is often practiced. While numerous pyrite-cleaning methods have been used in experiments, a common pyrite pretreatment method, often used to investigate pyrite chemistry by the isotopic fractionations associated with it, includes several rinses by HCl, acetone and deionized water. Elemental sulfur (S0) is a common product of incomplete pyrite oxidation. Removal of S0 is desirable to avoid experimental biases associated with its participation in pyrite transformations, but is more complicated than the removal of sulfate. Although rinsing with an organic solvent is in part aimed at removing S0, to the best of our knowledge, the extraction efficiency of S0 in existing protocols has not been assessed. We have developed and tested a new protocol for elemental sulfur removal from the surface of pyrite by ultrasonication with warm acetone. Our data demonstrate the presence of large fractions of S0 on untreated pyrite particle surfaces, of which only approximately 60% was removed by the commonly used pretreatment method. The new protocol described here was found to be more efficient at S0 removal than the commonly used method

A multicentre evaluation of two intensive care unit triage protocols for use in an influenza pandemic.

PubMed

Cheung, Winston K; Myburgh, John; Seppelt, Ian M; Parr, Michael J; Blackwell, Nikki; Demonte, Shannon; Gandhi, Kalpesh; Hoyling, Larissa; Nair, Priya; Passer, Melissa; Reynolds, Claire; Saunders, Nicholas M; Saxena, Manoj K; Thanakrishnan, Govindasamy

2012-08-06

To determine the increase in intensive care unit (ICU) bed availability that would result from the use of the New South Wales and Ontario Health Plan for an Influenza Pandemic (OHPIP) triage protocols. Prospective evaluation study conducted in eight Australian, adult, general ICUs, between September 2009 and May 2010. All patients who were admitted to the ICU, excluding those who had elective surgery, were prospectively evaluated using the two triage protocols, simulating a pandemic situation. Both protocols were originally developed to determine which patients should be excluded from accessing ICU resources during an influenza pandemic. Increase in ICU bed availability. At admission, the increases in ICU bed availability using Tiers 1, 2 and 3 of the NSW triage protocol were 3.5%, 14.7% and 22.7%, respectively, and 52.8% using the OHPIP triage protocol (P < 0.001). Re-evaluation of patients at 12 hours after admission using Tiers 1, 2 and 3 of the NSW triage protocol incrementally increased ICU bed availability by 19.2%, 16.1% and 14.1%, respectively (P < 0.001). The maximal cumulative increases in ICU bed availability using Tiers 1, 2 and 3 of the NSW triage protocol were 23.7%, 31.6% and 37.5%, respectively, at 72 hours (P < 0.001), and 65.0% using the OHPIP triage protocol, at 120 hours (P < 0.001). Both triage protocols resulted in increases in ICU bed availability, but the OHPIP protocol provided the greatest increase overall. With the NSW triage protocol, ICU bed availability increased as the protocol was escalated.

Joint power generation differentiates young and adult sprinters during the transition from block start into acceleration: a cross-sectional study.

PubMed

Debaere, Sofie; Vanwanseele, Benedicte; Delecluse, Christophe; Aerenhouts, Dirk; Hagman, Friso; Jonkers, Ilse

2017-11-01

The aim of this study was to investigate differences in joint power generation between well-trained adult athletes and young sprinters from block clearance to initial contact of second stance. Eleven under 16 (U16) and 18 under 18 (U18) promising sprinters executed an explosive start action. Fourteen well-trained adult sprinters completed the exact same protocol. All athletes were equipped with 74 spherical reflective markers, while an opto-electronic motion analysis system consisting of 12 infrared cameras (250 Hz, MX3, Vicon, Oxford Metrics, UK) and 2 Kistler force plates (1,000 Hz) was used to collect the three-dimensional marker trajectories and ground reaction forces (Nexus, Vicon). Three-dimensional kinematics, kinetics, and power were calculated (Opensim) and time normalised from the first action after gunshot until initial contact of second stance after block clearance. This study showed that adult athletes rely on higher knee power generation during the first stance to induce longer step length and therefore higher velocity. In younger athletes, power generation of hip was more dominant.

Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol.

PubMed

Röösli, Martin; Frei, Patrizia; Bolte, John; Neubauer, Georg; Cardis, Elisabeth; Feychting, Maria; Gajsek, Peter; Heinrich, Sabine; Joseph, Wout; Mann, Simon; Martens, Luc; Mohler, Evelyn; Parslow, Roger C; Poulsen, Aslak Harbo; Radon, Katja; Schüz, Joachim; Thuroczy, György; Viel, Jean-François; Vrijheid, Martine

2010-05-20

The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF) is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas.

Using research literature to develop a perceptual retraining treatment protocol.

PubMed

Neistadt, M E

1994-01-01

Treatment protocols derived from research literature can help therapists provide more rigorous treatment and more systematic assessment of client progress. This study applied research findings about the influence of task, subject, and feedback parameters on adult performance with block designs to an occupational therapy treatment protocol for parquetry block assembly--an activity occupational therapists use to remediate constructional deficits. Task parameter research suggests that parquetry tasks can be graded according to the features of the design cards, with cards having all block boundaries drawn in being easier than those with some block boundaries omitted. Subject parameter findings suggest that clients' lesions and initial constructional competence can influence their approaches to parquetry tasks. Feedback parameter research suggests that a combination of perceptual and planning cues is most effective for parquetry tasks. Methods to help clients transfer constructional skills from parquetry to functional tasks are also discussed.

Literature overview highlights lack of paediatric donation protocols but identifies common themes that could guide their development.

PubMed

Vileito, A; Siebelink, M J; Verhagen, Aae

2018-05-01

Paediatric donation is a unique and extremely sensitive process that requires specific knowledge and competencies. Most countries use protocols for organ and tissue donation to ensure optimal care for the donor and family, but these mainly focus on adults. However, the donation process for children differs from adults in many ways. An overview of the literature was performed to identify protocols for the paediatric population. PubMed, Web of Science, EMBASE and the Internet were searched up to March 2016 for papers or other sources in English related to specific organ and tissue donation protocols for children and neonates. This comprised title, abstract and then full-text screening of relevant data. We included 12 papers and two electronic sources that were mainly from North America and Europe. Most discussed donations after cardiac death. The recurring themes included identifying potential donors, approaching parents, palliative care and collaboration with organ procurement organisations. Most papers called for paediatric donation policies to be standardised. Scientific publications in English on paediatric donation protocols are very scarce. No comprehensive paediatric donation protocol was found. We identified several recurring themes in the literature that could be used to develop such protocols. ©2018 The Authors. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica.

Move to improve: the feasibility of using an early mobility protocol to increase ambulation in the intensive and intermediate care settings.

PubMed

Drolet, Anne; DeJuilio, Patti; Harkless, Sherri; Henricks, Sherry; Kamin, Elizabeth; Leddy, Elizabeth A; Lloyd, Joanna M; Waters, Carissa; Williams, Sarah

2013-02-01

Prolonged bed rest in hospitalized patients leads to deconditioning, impaired mobility, and the potential for longer hospital stays. The purpose of this study was to determine the effectiveness of a nurse-driven mobility protocol to increase the percentage of patients ambulating during the first 72 hours of their hospital stay. A quasi-experimental design was used before and after intervention in a 16-bed adult medical/surgical intensive care unit (ICU) and a 26-bed adult intermediate care unit (IMCU) at a large community hospital. A multidisciplinary team developed and implemented a mobility order set with an embedded algorithm to guide nursing assessment of mobility potential. Based on the assessments, the protocol empowers the nurse to consult physical therapists or occupational therapists when appropriate. Daily ambulation status reports were reviewed each morning to determine each patient's activity level. Retrospective and prospective chart reviews were performed to evaluate the effectiveness of the protocol for patients 18 years of age and older who were hospitalized 72 hours or longer. In the 3 months prior to implementation of the Move to Improve project, 6.2% (12 of 193) of the ICU patients and 15.5% (54 of 349) of the IMCU patients ambulated during the first 72 hours of their hospitalization. During the 6 months following implementation, those rates rose to 20.2% (86 of 426) and 71.8% (257 of 358), respectively. The study was carried out at only one center. The initial experience with a nurse-driven mobility protocol suggests that the rate of patient ambulation in an adult ICU and IMCU during the first 72 hours of a hospital stay can be increased.

Prehospital Care for the Adult and Pediatric Seizure Patient: Current Evidence-based Recommendations.

PubMed

Silverman, Eric C; Sporer, Karl A; Lemieux, Justin M; Brown, John F; Koenig, Kristi L; Gausche-Hill, Marianne; Rudnick, Eric M; Salvucci, Angelo A; Gilbert, Greg H

2017-04-01

We sought to develop evidence-based recommendations for the prehospital evaluation and treatment of adult and pediatric patients with a seizure and to compare these recommendations against the current protocol used by the 33 emergency medical services (EMS) agencies in California. We performed a review of the evidence in the prehospital treatment of patients with a seizure, and then compared the seizure protocols of each of the 33 EMS agencies for consistency with these recommendations. We analyzed the type and route of medication administered, number of additional rescue doses permitted, and requirements for glucose testing prior to medication. The treatment for eclampsia and seizures in pediatric patients were analyzed separately. Protocols across EMS Agencies in California varied widely. We identified multiple drugs, dosages, routes of administration, re-dosing instructions, and requirement for blood glucose testing prior to medication delivery. Blood glucose testing prior to benzodiazepine administration is required by 61% (20/33) of agencies for adult patients and 76% (25/33) for pediatric patients. All agencies have protocols for giving intramuscular benzodiazepines and 76% (25/33) have protocols for intranasal benzodiazepines. Intramuscular midazolam dosages ranged from 2 to 10 mg per single adult dose, 2 to 8 mg per single pediatric dose, and 0.1 to 0.2 mg/kg as a weight-based dose. Intranasal midazolam dosages ranged from 2 to 10 mg per single adult or pediatric dose, and 0.1 to 0.2 mg/kg as a weight-based dose. Intravenous/intrasosseous midazolam dosages ranged from 1 to 6 mg per single adult dose, 1 to 5 mg per single pediatric dose, and 0.05 to 0.1 mg/kg as a weight-based dose. Eclampsia is specifically addressed by 85% (28/33) of agencies. Forty-two percent (14/33) have a protocol for administering magnesium sulfate, with intravenous dosages ranging from 2 to 6 mg, and 58% (19/33) allow benzodiazepines to be administered. Protocols for a patient

Prevention of nosocomial infections in critically ill patients with lactoferrin (PREVAIL study): study protocol for a randomized controlled trial.

PubMed

Muscedere, John; Maslove, David; Boyd, John Gordon; O'Callaghan, Nicole; Lamontagne, Francois; Reynolds, Steven; Albert, Martin; Hall, Rick; McGolrick, Danielle; Jiang, Xuran; Day, Andrew G

2016-09-29

Nosocomial infections remain an important source of morbidity, mortality, and increased health care costs in hospitalized patients. This is particularly problematic in intensive care units (ICUs) because of increased patient vulnerability due to the underlying severity of illness and increased susceptibility from utilization of invasive therapeutic and monitoring devices. Lactoferrin (LF) and the products of its breakdown have multiple biological effects, which make its utilization of interest for the prevention of nosocomial infections in the critically ill. This is a phase II randomized, multicenter, double-blinded trial to determine the effect of LF on antibiotic-free days in mechanically ventilated, critically ill, adult patients in the ICU. Eligible, consenting patients will be randomized to receive either LF or placebo. The treating clinician will remain blinded to allocation during the study; blinding will be maintained by using opaque syringes and containers. The primary outcome will be antibiotic-free days, defined as the number of days alive and free of antibiotics 28 days after randomization. Secondary outcomes will include: antibiotic utilization, adjudicated diagnosis of nosocomial infection (longer than 72 h of admission to ICU), hospital and ICU length of stay, change in organ function after randomization, hospital and 90-day mortality, incidence of tracheal colonization, changes in gastrointestinal permeability, and immune function. Outcomes to inform the conduct of a larger definitive trial will also be evaluated, including feasibility as determined by recruitment rates and protocol adherence. The results from this study are expected to provide insight into a potential novel therapeutic use for LF in critically ill adult patients. Further, analysis of study outcomes will inform a future, large-scale phase III randomized controlled trial powered on clinically important outcomes related to the use of LF. The trial was registered at www

Computer-Tutors and a Freshman Writer: A Protocol Study.

ERIC Educational Resources Information Center

Strickland, James

Although there are many retrospective accounts from teachers and professional writers concerning the effect of computers on their writing, there are few real-time accounts of students struggling to simultaneously develop as writers and cope with computers. To fill this void in "testimonial data," a study examining talking-aloud protocols from a…

Safety of 8-aminoquinolines given to people with G6PD deficiency: protocol for systematic review of prospective studies

PubMed Central

Uthman, Olalekan A; Saunders, Rachel; Sinclair, David; Graves, Patricia; Gelband, Hellen; Clarke, Aileen; Garner, Paul

2014-01-01

Introduction A single dose or short course of primaquine given to people infected with malaria may reduce transmission of Plasmodium falciparum through its effects on gametocytes. Primaquine is also known to cause haemolysis in people with variants of glucose-6-phosphate dehydrogenase (G6PD) deficiency. The objective of this systematic review was to assess the risk of adverse effects in people with G6PD deficiency given primaquine or other 8-aminoquinoline (8AQ) as a single dose or short course (less than 7 days). Methods and analysis We will search the following databases: Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS. Prospective cohort studies, randomised and quasi-randomised trials that evaluated 8AQs for whatever reason in adults or children with a known G6PD deficiency will be included. Two authors will independently assess each study for eligibility, risk of bias and extract data. Ethics and dissemination This systematic review will be published in a peer-reviewed journal. Brief reports of the review findings will be disseminated directly to the appropriate audiences and the WHO Technical Expert Group in Malaria Chemotherapy. As no primary data collection will be undertaken, no additional formal ethical assessment and informed consent are required. Protocol registration in PROSPERO The protocol is registered with PROSPERO, registration number CRD42013006518. PMID:24833685

Case Studies in Australian Adult Education.

ERIC Educational Resources Information Center

Clark, Ralph J., Ed.; Rooth, S. John, Ed.

This publication contains the following 24 case studies of adult education in Australia: "NSW Department of Agriculture Home Study Programme" (O'Neill); "Self-Help Adult Education: The University of the Third Age at the Brisbane CAE" (Swindell); "Marriage Enrichment Programme" (D. Kerr, C. Kerr); "Carringbush…

Usefulness of an injectable anaesthetic protocol for semen collection through urethral catheterisation in domestic cats.

PubMed

Pisu, Maria Carmela; Ponzio, Patrizia; Rovella, Chiara; Baravalle, Michela; Veronesi, Maria Cristina

2017-10-01

Objectives Although less often requested in comparison with dogs, the collection of semen in cats can be necessary for artificial insemination, for semen evaluation in tom cats used for breeding and for semen storage. Urethral catheterisation after pharmacological induction with medetomidine has proved to be useful for the collection of semen in domestic cats. However, most of the previously used protocols require the administration of high doses of medetomidine that can increase the risk of side effects, especially on the cardiovascular system. In routine clinical practice, one safe and useful injectable anaesthetic protocol for short-term clinical investigations or surgery in cats involves premedication with low intramuscular doses of dexmedetomidine with methadone, followed by intravenous propofol bolus injection. We aimed to assess the usefulness of this injectable anaesthetic protocol for semen collection, via urethral catheterisation, in domestic cats. Methods The study was performed on 38 purebred, adult cats, during the breeding season, and semen was collected via urethral catheterisation using an injectable anaesthesia protocol with methadone (0.2 mg/kg) and dexmedetomidine (5 µg/kg) premedication, followed by induction with propofol. Results The anaesthetic protocol used in the present study allowed the collection of large-volume semen samples, characterised by good parameters and without side effects. Conclusions and relevance The results from the present study suggest that the injectable anaesthetic protocol using methadone and dexmedetomidine premedication, followed by induction with propofol, could be suitable and safe for the collection of a good-quality semen sample, via urethral catheterisation, in domestic cats. It can therefore be used as an alternative to previous medetomidine-based sedation protocols.

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial.

PubMed

Williams, Hants; Silva, Susan; Simmons, Leigh Ann; Tanabe, Paula

2017-05-15

One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability. In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain. ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.

What is the quality of reporting on guideline, protocol or algorithm implementation in adult trauma centres? Protocol for a systematic review.

PubMed

Gotlib Conn, Lesley; Nathens, Avery B; Perrier, Laure; Haas, Barbara; Watamaniuk, Aaron; Daniel Pereira, Diego; Zwaiman, Ashley; da Luz, Luis Teodoro

2018-05-09

Quality improvement (QI) is mandatory in trauma centres but there is no prescription for doing successful QI. Considerable variation in implementation strategies and inconsistent use of evidence-based protocols therefore exist across centres. The quality of reporting on these strategies may limit the transferability of successful initiatives across centres. This systematic review will assess the quality of reporting on guideline, protocol or algorithm implementation within a trauma centre in terms of the Revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0). We will search for English language articles published after 2010 in EMBASE, MEDLINE, CINAHL electronic databases and the Cochrane Central Register of Controlled Trials. The database search will be supplemented by searching trial registries and grey literature online. Included studies will evaluate the effectiveness of guideline implementation in terms of change in clinical practice or improvement in patient outcomes. The primary outcome will be a global score reporting the proportion of studies respecting at least 80% of the SQUIRE 2.0 criteria and will be obtained based on the 18-items identified in the SQUIRE 2.0 guidelines. Secondary outcome will be the risk of bias assessed with the Risk Of Bias In Non-randomised Studies- of Interventions tool for observational cohort studies and with the Cochrane Collaboration tool for randomised controlled trials. Meta-analyses will be conducted in randomised controlled trials to estimate the effectiveness of guideline implementation if studies are not heterogeneous. If meta-analyses are conducted, we will combine studies according to the risk of bias (low, moderate or high/unclear) in subgroup analyses. All study titles, abstracts and full-text screening will be completed independently and in duplicate by the review team members. Data extraction and risk of bias assessment will also be done independently and in duplicate. Results will be

A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

PubMed

Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

2018-05-15

To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

Research Protocol: Collections Related to Synthetic Turf ...

EPA Pesticide Factsheets

The “Federal Research Action Plan on Recycled Tire Crumb Used on Playing Fields and Playgrounds” (referred to subsequently as the Federal Research Action Plan or FRAP) was finalized in February 2016. The U.S. EPA and CDC/ATSDR, in collaboration with CPSC, have prepared this research protocol to implement portions of the research activities outlined under the FRAP. Specifically, this research protocol is designed to implement three of the research elements described in the Federal Research Action Plan: Conduct a literature review and data gaps analysis; Perform tire crumb rubber characterization research; Perform human exposure characterization research. Concerns have been raised by the public about the safety of recycled tire crumb rubber used in synthetic turf fields and playgrounds in the United States. Several studies have been identified that examine exposure to tire crumb rubber infill in these settings. While, in general, these studies have not provided evidence for these health concerns, the existing studies do not comprehensively evaluate all aspects of exposure associated with these use scenarios. Additional research is needed to help fill important data gaps that will lead to improved exposure assessment and risk evaluation for children and adults using synthetic turf fields and playgrounds with tire crumb rubber. In response, the U.S. Environmental Protection Agency (EPA), the Centers for Disease Control and Prevention/Agency for Toxic Su

Internet-based self-help therapy with FearFighter™ versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial.

PubMed

Fenger, Morten; Lindschou, Jane; Gluud, Christian; Winkel, Per; Jørgensen, Lise; Kruse-Blinkenberg, Sten; Lau, Marianne

2016-10-28

Internet-based self-help psychotherapy (IBT) could be an important alternative or supplement to ordinary face-to-face therapy. The findings of randomised controlled trials indicate that the effects of various IBT programmes for anxiety disorders seem better than no intervention and in some instances are equivalent to usual therapy. In Denmark, IBT is part of future treatment plans in mental health care services, but the verification level of the current clinical scientific knowledge is insufficient. The objective of this trial is feasibility assessment of benefits and harms of the Internet-based cognitive behavioural therapy (ICBT) programme FearFighter™ versus no intervention for anxiety disorders in adults. We will conduct an investigator-initiated, feasibility randomised controlled trial. Sixty-four participants are expected to be recruited via an advertisement posted on the homepage of the Student Counselling Service in Denmark. The inclusion criterion for participation in the trial will be the presence of anxiety disorder as assessed with the Mini International Neuropsychiatric Interview. The exclusion criteria will be suicidal risk, an ongoing episode of bipolar disorder or psychosis, concurrent psychological treatment for the anxiety disorder, considered unable to attend the intervention as planned (due to vacation, work/study placement, sickness, or similar occurrences), or lack of informed consent. The intervention group will be offered nine sessions with the ICBT programme FearFighter™ and a weekly telephone contact to support compliance. The control group will receive no intervention. We define the feasibility outcomes as follows: the fraction of randomised participants out of the eligible people (the lower 95 % confidence interval (CI) ≥ 50 %); and the fraction of compliant participants (those receiving at least six out of nine sessions) in the intervention group (the lower 95 % CI ≥ 60 %). The exploratory clinical outcomes are the

Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial Study Protocol

PubMed Central

Struik, Laura Louise; Hammond, David; Guindon, G Emmanuel; Norman, Cameron D; Whittaker, Robyn; Burns, Catherine M; Grindrod, Kelly A; Brown, K Stephen

2015-01-01

Background Tobacco use remains the number one cause of preventable chronic disease and death in developed countries worldwide. In North America, smoking rates are highest among young adults. Despite that the majority of young adult smokers indicate wanting to quit, smoking rates among this age demographic have yet to decline. Helping young adults quit smoking continues to be a public health priority. Digital mobile technology presents a promising medium for reaching this population with smoking cessation interventions, especially because young adults are the heaviest users of this technology. Objective The primary aim of this trial is to determine the effectiveness of an evidence-informed mobile phone app for smoking cessation, Crush the Crave, on reducing smoking prevalence among young adult smokers. Methods A parallel randomized controlled trial (RCT) with two arms will be conducted in Canada to evaluate Crush the Crave. In total, 1354 young adult smokers (19 to 29 years old) will be randomized to receive the evidence-informed mobile phone app, Crush the Crave, or an evidence-based self-help guide known as “On the Road to Quitting” (control) for a period of 6 months. The primary outcome measure is a 30-day point prevalence of abstinence at the 6-month follow-up. Secondary outcomes include a 7-day point prevalence of abstinence, number of quit attempts, reduction in consumption of cigarettes, self-efficacy, satisfaction, app utilization metrics, and use of smoking cessation services. A cost-effectiveness analysis is included. Results This trial is currently open for recruitment. The anticipated completion date for the study is April 2016. Conclusions This randomized controlled trial will provide the evidence to move forward on decision making regarding the inclusion of technology-based mobile phone interventions as part of existing smoking cessation efforts made by health care providers. Evidence from the trial will also inform the development of future apps

Effect of a mobile phone intervention on quitting smoking in a young adult population of smokers: randomized controlled trial study protocol.

PubMed

Baskerville, Neill Bruce; Struik, Laura Louise; Hammond, David; Guindon, G Emmanuel; Norman, Cameron D; Whittaker, Robyn; Burns, Catherine M; Grindrod, Kelly A; Brown, K Stephen

2015-01-19

Tobacco use remains the number one cause of preventable chronic disease and death in developed countries worldwide. In North America, smoking rates are highest among young adults. Despite that the majority of young adult smokers indicate wanting to quit, smoking rates among this age demographic have yet to decline. Helping young adults quit smoking continues to be a public health priority. Digital mobile technology presents a promising medium for reaching this population with smoking cessation interventions, especially because young adults are the heaviest users of this technology. The primary aim of this trial is to determine the effectiveness of an evidence-informed mobile phone app for smoking cessation, Crush the Crave, on reducing smoking prevalence among young adult smokers. A parallel randomized controlled trial (RCT) with two arms will be conducted in Canada to evaluate Crush the Crave. In total, 1354 young adult smokers (19 to 29 years old) will be randomized to receive the evidence-informed mobile phone app, Crush the Crave, or an evidence-based self-help guide known as "On the Road to Quitting" (control) for a period of 6 months. The primary outcome measure is a 30-day point prevalence of abstinence at the 6-month follow-up. Secondary outcomes include a 7-day point prevalence of abstinence, number of quit attempts, reduction in consumption of cigarettes, self-efficacy, satisfaction, app utilization metrics, and use of smoking cessation services. A cost-effectiveness analysis is included. This trial is currently open for recruitment. The anticipated completion date for the study is April 2016. This randomized controlled trial will provide the evidence to move forward on decision making regarding the inclusion of technology-based mobile phone interventions as part of existing smoking cessation efforts made by health care providers. Evidence from the trial will also inform the development of future apps, provide a deeper understanding of the factors that

Randomized control trial of computer-based training targeting alertness in older adults: the ALERT trial protocol.

PubMed

VanVleet, Thomas; Voss, Michelle; Dabit, Sawsan; Mitko, Alex; DeGutis, Joseph

2018-05-03

Healthy aging is associated with a decline in multiple functional domains including perception, attention, short and long-term memory, reasoning, decision-making, as well as cognitive and motor control functions; all of which are significantly modulated by an individual's level of alertness. The control of alertness also significantly declines with age and contributes to increased lapses of attention in everyday life, ranging from minor memory slips to a lack of vigilance and increased risk of falls or motor-vehicle accidents. Several experimental behavioral therapies designed to remediate age-related cognitive decline have been developed, but differ widely in content, method and dose. Preliminary studies demonstrate that Tonic and Phasic Alertness Training (TAPAT) can improve executive functions in older adults and may be a useful adjunct treatment to enhance benefits gained in other clinically validated treatments. The purpose of the current trial (referred to as the Attention training for Learning Enhancement and Resilience Trial or ALERT) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes. We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 120 patients with age-related cognitive decline. Patients will be asked to complete 36 training sessions remotely (30 min/day, 5 days a week, over 3 months) of either the experimental TAPAT training program or an active control computer games condition. Patients will be assessed on a battery of cognitive and functional outcomes at four time points, including: a) immediately before training, b) halfway through training, c) within forty-eight hours post completion of total training, and d) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects. The strengths of this protocol are that it tests an

Neighbourhood environment, physical activity, quality of life and depressive symptoms in Hong Kong older adults: a protocol for an observational study

PubMed Central

Cerin, Ester; Sit, Cindy H P; Zhang, Casper J P; Barnett, Anthony; Cheung, Martin M C; Lai, Poh-chin; Johnston, Janice M; Lee, Ruby S Y

2016-01-01

Introduction The neighbourhood environment can assist the adoption and maintenance of an active lifestyle and affect the physical and mental well-being of older adults. The psychosocial and behavioural mechanisms through which the environment may affect physical and mental well-being are currently poorly understood. Aim This observational study aims to examine associations between the physical and social neighbourhood environments, physical activity, quality of life and depressive symptoms in Chinese Hong Kong older adults. Methods and analyses An observational study of the associations of measures of the physical and social neighbourhood environment, and psychosocial factors, with physical activity, quality of life and depressive symptoms in 900 Hong Kong older adults aged 65+ years is being conducted in 2012–2016. The study involves two assessments taken 6 months apart. Neighbourhood walkability and access to destinations are objectively measured using Geographic Information Systems and environmental audits. Demographics, socioeconomic status, walking for different purposes, perceived neighbourhood and home environments, psychosocial factors, health status, social networks, depressive symptoms and quality of life are being assessed using validated interviewer-administered self-report measures and medical records. Physical functionality is being assessed using the Short Physical Performance Battery. Physical activity and sedentary behaviours are also being objectively measured in approximately 45% of participants using accelerometers over a week. Physical activity, sedentary behaviours, quality of life and depressive symptoms are being assessed twice (6 months apart) to examine seasonality effects on behaviours and their associations with quality of life and depressive symptoms. Ethics and dissemination The study received ethical approval from the University of Hong Kong Human Research Ethics Committee for Non-Clinical Faculties (EA270211) and the Department

The healthy steps study: a randomized controlled trial of a pedometer-based green prescription for older adults. Trial protocol.

PubMed

Kolt, Gregory S; Schofield, Grant M; Kerse, Ngaire; Garrett, Nicholas; Schluter, Philip J; Ashton, Toni; Patel, Asmita

2009-11-01

Graded health benefits of physical activity have been demonstrated for the reduction of coronary heart disease, some cancers, and type-2 diabetes, and for injury reduction and improvements in mental health. Older adults are particularly at risk of physical inactivity, and would greatly benefit from successful targeted physical activity interventions. The Healthy Steps study is a 12-month randomized controlled trial comparing the efficacy of a pedometer-based Green Prescription with the conventional time-based Green Prescription in increasing and maintaining physical activity levels in low-active adults over 65 years of age. The Green Prescription interventions involve a primary care physical activity prescription with 3 follow-up telephone counselling sessions delivered by trained physical activity counsellors over 3 months. Those in the pedometer group received a pedometer and counselling based around increasing steps that can be monitored on the pedometer, while those in the standard Green Prescription group received counselling using time-based goals. Baseline, 3 month (end of intervention), and 12 month measures were assessed in face-to-face home visits with outcomes measures being physical activity (Auckland Heart Study Physical Activity Questionnaire), quality of life (SF-36 and EQ-5D), depressive symptoms (Geriatric Depression Scale), blood pressure, weight status, functional status (gait speed, chair stands, and tandem balance test) and falls and adverse events (self-report). Utilisation of health services was assessed for the economic evaluation carried out alongside this trial. As well, a process evaluation of the interventions and an examination of barriers and motives for physical activity in the sample were conducted. The perceptions of primary care physicians in relation to delivering physical activity counselling were also assessed. The findings from the Healthy Steps trial are due in late 2009. If successful in improving physical activity in older

Study protocol and overview of the literature on long-term health and quality of life outcomes in patients treated in adolescence for scoliosis with therapeutic exercises.

PubMed

Plaszewski, Maciej; Kotwicki, Tomasz; Chwala, Wieslaw; Terech, Jacek; Cieśliński, Igor

2015-01-01

Scoliosis, the most prevalent orthopaedic condition affecting children and adolescents, may have lasting physical, psychological and social consequences. With limited evidence-base, scoliosis-specific exercise therapies are an option. An overview of the subject and description of a long-term follow-up study including adults who in adolescence were treated with a scoliosis-specific exercise programme investigating the association of the exercise regime with present physical activity, physical functioning and subjective wellbeing. To the authors' best knowledge, this is the first long-term outcome study on scoliosis-specific exercises, in opposition to a number of studies in adults who were braced or treated surgically in adolescence. Observational, registry-based case-control study. Adult subjects who in adolescence were treated with an exercise programme or were under observation are invited. Spine and trunk deformity, respiratory function, physical capacity and trunk muscles' function are measured. Health-related quality of life with generic and condition-specific instruments, general mental health, depression and anxiety symptoms, disability due to low back problems and physical activity are assessed. The report is believed to provide the readers with an overview of this controversial aspect of rehabilitation, and that the proposed protocol will assist researchers designing their studies.

Exploring the feasibility and acceptability of a recovery-focused group therapy intervention for adults with bipolar disorder: trial protocol

PubMed Central

Beck, Alison K; Baker, Amanda; Jones, Steven; Lobban, Fiona; Kay-Lambkin, Frances; Attia, John; Banfield, Michelle

2018-01-01

Introduction Improving accessible, acceptable recovery-oriented service provision for people with bipolar disorder (BD) is an important priority. Mindfulness and acceptance-based cognitive and behavioural therapies (or ‘third -wave’ CBT) may prove fruitful due to the considerable overlap between these approaches and key features of personal recovery. Groups also confer therapeutic benefits consistent with personal recovery and may improve recovery-oriented service provision by adding another modality for accessing support. The primary objective of this trial is to explore the feasibility and acceptability of a new recovery-focused group therapy (RfGT) intervention for adults with BD. This is the first published feasibility assessment of a time-limited RfGTrecovery-focused group therapy intervention for BD. Methods/analysis This protocol describes an open feasibility study, utilising a pre-treatment design versus post- treatment design and nested qualitative evaluation. Participants will be recruited from the Central Coast region of New South Wales, Australia, from primary care providers, specialist mental health services, non-government organisations and via self-referral. The primary outcomes are feasibility and acceptability as indexed by recruitment, retention, intervention adherence, adverse events (if any) and detailed consumer feedback. Clinical outcomes and process measures will be assessed to inform future research. Primary outcome data will utiliseuse descriptive statistics (eg, summarizingsummarising recruitment, demographics, attendance, attrition and intervention adherence). Secondary outcomes will be assessed using repeated-measures analysis of covariance across all time points (including change, effect size and variability). Ethics and dissemination Ethical approval has been granted by the Northern Sydney Local Health District HREChuman research ethics committee (HREC) (HREC/16/HAWKE/69) and The University of Newcastle HREC (H-2016–0107). The

Clinical grade adult stem cell banking

PubMed Central

Thirumala, Sreedhar; Goebel, W Scott

2009-01-01

There has been a great deal of scientific interest recently generated by the potential therapeutic applications of adult stem cells in human care but there are several challenges regarding quality and safety in clinical applications and a number of these challenges relate to the processing and banking of these cells ex-vivo. As the number of clinical trials and the variety of adult cells used in regenerative therapy increases, safety remains a primary concern. This has inspired many nations to formulate guidelines and standards for the quality of stem cell collection, processing, testing, banking, packaging and distribution. Clinically applicable cryopreservation and banking of adult stem cells offers unique opportunities to advance the potential uses and widespread implementation of these cells in clinical applications. Most current cryopreservation protocols include animal serum proteins and potentially toxic cryoprotectant additives (CPAs) that prevent direct use of these cells in human therapeutic applications. Long term cryopreservation of adult stem cells under good manufacturing conditions using animal product free solutions is critical to the widespread clinical implementation of ex-vivo adult stem cell therapies. Furthermore, to avoid any potential cryoprotectant related complications, reduced CPA concentrations and efficient post-thaw washing to remove CPA are also desirable. The present review focuses on the current strategies and important aspects of adult stem cell banking for clinical applications. These include current good manufacturing practices (cGMPs), animal protein free freezing solutions, cryoprotectants, freezing & thawing protocols, viability assays, packaging and distribution. The importance and benefits of banking clinical grade adult stem cells are also discussed. PMID:20046678

The effects of a mindfulness-based lifestyle programme for adults with Parkinson’s disease: protocol for a mixed methods, randomised two-group control study

PubMed Central

Advocat, Jenny; Russell, Grant; Enticott, Joanne; Hassed, Craig; Hester, Jennifer; Vandenberg, Brooke

2013-01-01

Introduction Parkinson's disease (PD) is the second most common neurodegenerative disorder in developed countries. There is an increasing interest in the use of mindfulness-related interventions in the management of patients with a chronic disease. In addition, interventions that promote personal control, stress-management and other lifestyle factors, such as diet and exercise, assist in reducing disability and improving quality of life in people with chronic illnesses. There has been little research in this area for people with PD. Methods A prospective mixed-method randomised clinical trial involving community living adults with PD aged <76 years and with moderate disease severity (Hoehn and Yahr stage 2) PD. Participants will be randomised into the ESSENCE 6-week programme or a matched wait list control group. ESSENCE is a multifaceted, healthy lifestyle and mindfulness programme designed to improve quality of life. We aim to determine whether participation in a mindfulness and lifestyle programme could improve PD-related function and explore self-management related experiences and changing attitudes towards self-management. The outcome measures will include 5 self-administered questionnaires: PD function and well-being questionnaire (PDQ39), Health Behaviours, Mental health, Multidimensional locus of control, and Freiburg mindfulness inventory. An embedded qualitative protocol will include in-depth interviews with 12 participants before and after participation in the 6-week programme and a researcher will observe the programme and take notes. Analysis Repeated measures of Analysis of Variance (ANOVA) will examine the outcome measures for any significant effects from the group allocation, age, sex, adherence score and attendance. Qualitative data will be analysed thematically. We will outline the benefits of, and barriers to, the uptake of the intervention. Ethics This protocol has received ethics approval from the Monash University Human Research Ethics

Systematic literature review of determinants of sedentary behaviour in older adults: a DEDIPAC study.

PubMed

Chastin, Sebastien F M; Buck, Christoph; Freiberger, Ellen; Murphy, Marie; Brug, Johannes; Cardon, Greet; O'Donoghue, Grainne; Pigeot, Iris; Oppert, Jean-Michel

2015-10-06

Older adults are the most sedentary segment of society and high sedentary time is associated with poor health and wellbeing outcomes in this population. Identifying determinants of sedentary behaviour is a necessary step to develop interventions to reduce sedentary time. A systematic literature review was conducted to identify factors associated with sedentary behaviour in older adults. Pubmed, Embase, CINAHL, PsycINFO and Web of Science were searched for articles published between 2000 and May 2014. The search strategy was based on four key elements: (a) sedentary behaviour and its synonyms; (b) determinants and its synonyms (e.g. correlates, factors); (c) types of sedentary behaviour (e.g. TV viewing, sitting, gaming) and (d) types of determinants (e.g. environmental, behavioural). Articles were included in the review if specific information about sedentary behaviour in older adults was reported. Studies on samples identified by disease were excluded. Study quality was rated by means of QUALSYST. The full review protocol is available from PROSPERO (PROSPERO 2014: CRD42014009823). The analysis was guided by the socio-ecological model framework. Twenty-two original studies were identified out of 4472 returned by the systematic search. These included 19 cross-sectional, 2 longitudinal and 1 qualitative studies, all published after 2011. Half of the studies were European. The study quality was generally high with a median of 82 % (IQR 69-96 %) using Qualsyst tool. Personal factors were the most frequently investigated with consistent positive association for age, negative for retirement, obesity and health status. Only four studies considered environmental determinants suggesting possible association with mode of transport, type of housing, cultural opportunities and neighbourhood safety and availability of places to rest. Only two studies investigated mediating factors. Very limited information was available on contexts and sub-domains of sedentary behaviours. Few

Planned development and evaluation protocol of two versions of a web-based computer-tailored nutrition education intervention aimed at adults, including cognitive and environmental feedback

PubMed Central

2014-01-01

Background Despite decades of nutrition education, the prevalence of unhealthy dietary patterns is still high and inequalities in intake between high and low socioeconomic groups still exist. Therefore, it is important to innovate and improve existing nutrition education interventions. This paper describes the development, design and evaluation protocol of a web-based computer-tailored nutrition education intervention for adults targeting fruit, vegetable, high-energy snack and fat intake. This intervention innovates existing computer-tailored interventions by not only targeting motivational factors, but also volitional and self-regulation processes and environmental-level factors. Methods/design The intervention development was guided by the Intervention Mapping protocol, ensuring a theory-informed and evidence-based intervention. Two versions of the intervention were developed: a basic version targeting knowledge, awareness, attitude, self-efficacy and volitional and self-regulation processes, and a plus version additionally addressing the home environment arrangement and the availability and price of healthy food products in supermarkets. Both versions consist of four modules: one for each dietary behavior, i.e. fruit, vegetables, high-energy snacks and fat. Based on the self-regulation phases, each module is divided into three sessions. In the first session, feedback on dietary behavior is provided to increase awareness, feedback on attitude and self-efficacy is provided and goals and action plans are stated. In the second session goal achievement is evaluated, reasons for failure are explored, coping plans are stated and goals can be adapted. In the third session, participants can again evaluate their behavioral change and tips for maintenance are provided. Both versions will be evaluated in a three-group randomized controlled trial with measurements at baseline, 1-month, 4-months and 9-months post-intervention, using online questionnaires. Both versions will

Development of a bedside viable ultrasound protocol to quantify appendicular lean tissue mass

PubMed Central

Paris, Michael T.; Lafleur, Benoit; Dubin, Joel A.

2017-01-01

Abstract Background Ultrasound is a non‐invasive and readily available tool that can be prospectively applied at the bedside to assess muscle mass in clinical settings. The four‐site protocol, which images two anatomical sites on each quadriceps, may be a viable bedside method, but its ability to predict musculature has not been compared against whole‐body reference methods. Our primary objectives were to (i) compare the four‐site protocol's ability to predict appendicular lean tissue mass from dual‐energy X‐ray absorptiometry; (ii) optimize the predictability of the four‐site protocol with additional anatomical muscle thicknesses and easily obtained covariates; and (iii) assess the ability of the optimized protocol to identify individuals with low lean tissue mass. Methods This observational cross‐sectional study recruited 96 university and community dwelling adults. Participants underwent ultrasound scans for assessment of muscle thickness and whole‐body dual‐energy X‐ray absorptiometry scans for assessment of appendicular lean tissue. Ultrasound protocols included (i) the nine‐site protocol, which images nine anterior and posterior muscle groups in supine and prone positions, and (ii) the four‐site protocol, which images two anterior sites on each quadriceps muscle group in a supine position. Results The four‐site protocol was strongly associated (R 2 = 0.72) with appendicular lean tissue mass, but Bland–Altman analysis displayed wide limits of agreement (−5.67, 5.67 kg). Incorporating the anterior upper arm muscle thickness, and covariates age and sex, alongside the four‐site protocol, improved the association (R 2 = 0.91) with appendicular lean tissue and displayed narrower limits of agreement (−3.18, 3.18 kg). The optimized protocol demonstrated a strong ability to identify low lean tissue mass (area under the curve = 0.89). Conclusions The four‐site protocol can be improved with the addition of the anterior upper

The effect of an interactive cycling training on cognitive functioning in older adults with mild dementia: study protocol for a randomized controlled trial.

PubMed

Karssemeijer, E G A; Bossers, W J R; Aaronson, J A; Kessels, R P C; Olde Rikkert, M G M

2017-03-21

To date there is no cure or an effective disease-modifying drug to treat dementia. Available acetylcholine-esterase inhibiting drugs or memantine only produce small benefits on cognitive and behavioural functioning and their clinical relevance remains controversial. Combined cognitive-aerobic interventions are an appealing alternative or add-on to current pharmacological treatments. The primary aim of this study is to investigate the efficacy of a combined cognitive-aerobic training and a single aerobic training compared to an active control group in older adults with mild dementia. We expect to find a beneficial effect on executive functioning in both training regimes, compared to the control intervention, with the largest effect in the combined cognitive-aerobic group. Secondary, intervention effects on cognitive functioning in other domains, physical functioning, physical activity levels, activities of daily living, frailty and quality of life are studied. The design is a single-blind, randomized controlled trial (RCT) with three groups: a combined cognitive-aerobic bicycle training (interactive cycling), a single aerobic bicycle training and a control intervention, which consists of stretching and toning exercises. Older adults with mild dementia follow a 12-week training program consisting of three training sessions of 30-40 min per week. The primary study outcome is objective executive functioning measured with a neuropsychological assessment. Secondary measures are objective cognitive functioning in other domains, physical functioning, physical activity levels, activities of daily living, frailty, mood and quality of life. The three groups are compared at baseline, after 6 and 12 weeks of training, and at 24-week follow-up. This study will provide novel information on the effects of an interactive cycling training on executive function in older adults with mild dementia. Furthermore, since this study has both a combined cognitive-aerobic training and a

Acute lymphoblastic leukemia in adolescents and young adults.

PubMed

Burke, Patrick W; Douer, Dan

2014-01-01

The cure rate of acute lymphoblastic leukemia (ALL) in children is 80%, compared to less than half in adults. A major proportion of this cure rate drop occurs in adolescents and young adults (AYAs). The age range defining this population varies between studies, biological characteristics are different from both younger children and older adults, and AYAs are treated either by pediatric or adult oncologists, who often apply different treatment approaches to the same ALL patient population. The outcome of AYAs aged 15-21 years treated by more contemporary pediatric protocols is similar to that of younger children but is inferior when using adult regimens. This motivated studying AYA patients, including those above the age of 21 years, with pediatric or 'pediatrics-inspired' regimens that intensified nonmyelosuppressive drugs such as vincristine, steroids and asparaginase, with very promising preliminary results. Discovering new mutations in AYA ALL will help stratify patients into risk subgroups and identify targets for novel agents. This, together with fine-tuning pediatric chemotherapy principles will hopefully finally decrease the cure rate gap between children and AYAs - and even older adults. © 2014 S. Karger AG, Basel.

Do we need 3D tube current modulation information for accurate organ dosimetry in chest CT? Protocols dose comparisons.

PubMed

Lopez-Rendon, Xochitl; Zhang, Guozhi; Coudyzer, Walter; Develter, Wim; Bosmans, Hilde; Zanca, Federica

2017-11-01

To compare the lung and breast dose associated with three chest protocols: standard, organ-based tube current modulation (OBTCM) and fast-speed scanning; and to estimate the error associated with organ dose when modelling the longitudinal (z-) TCM versus the 3D-TCM in Monte Carlo simulations (MC) for these three protocols. Five adult and three paediatric cadavers with different BMI were scanned. The CTDI vol of the OBTCM and the fast-speed protocols were matched to the patient-specific CTDI vol of the standard protocol. Lung and breast doses were estimated using MC with both z- and 3D-TCM simulated and compared between protocols. The fast-speed scanning protocol delivered the highest doses. A slight reduction for breast dose (up to 5.1%) was observed for two of the three female cadavers with the OBTCM in comparison to the standard. For both adult and paediatric, the implementation of the z-TCM data only for organ dose estimation resulted in 10.0% accuracy for the standard and fast-speed protocols, while relative dose differences were up to 15.3% for the OBTCM protocol. At identical CTDI vol values, the standard protocol delivered the lowest overall doses. Only for the OBTCM protocol is the 3D-TCM needed if an accurate (<10.0%) organ dosimetry is desired. • The z-TCM information is sufficient for accurate dosimetry for standard protocols. • The z-TCM information is sufficient for accurate dosimetry for fast-speed scanning protocols. • For organ-based TCM schemes, the 3D-TCM information is necessary for accurate dosimetry. • At identical CTDI vol , the fast-speed scanning protocol delivered the highest doses. • Lung dose was higher in XCare than standard protocol at identical CTDI vol .

Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol

PubMed Central

2010-01-01

Background The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF) is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. Methods The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. Results We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Conclusion Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas. PMID:20487532

The feasibility of universal DLP-to-risk conversion coefficients for body CT protocols

NASA Astrophysics Data System (ADS)

Li, Xiang; Samei, Ehsan; Segars, W. Paul; Paulson, Erik K.; Frush, Donald P.

2011-03-01

The effective dose associated with computed tomography (CT) examinations is often estimated from dose-length product (DLP) using scanner-independent conversion coefficients. Such conversion coefficients are available for a small number of examinations, each covering an entire region of the body (e.g., head, neck, chest, abdomen and/or pelvis). Similar conversion coefficients, however, do not exist for examinations that cover a single organ or a sub-region of the body, as in the case of a multi-phase liver examination. In this study, we extended the DLP-to-effective dose conversion coefficient (k factor) to a wide range of body CT protocols and derived the corresponding DLP-to-cancer risk conversion coefficient (q factor). An extended cardiactorso (XCAT) computational model was used, which represented a reference adult male patient. A range of body CT protocols used in clinical practice were categorized based on anatomical regions examined into 10 protocol classes. A validated Monte Carlo program was used to estimate the organ dose associated with each protocol class. Assuming the reference model to be 20 years old, effective dose and risk index (an index of the total risk for cancer incidence) were then calculated and normalized by DLP to obtain the k and q factors. The k and q factors varied across protocol classes; the coefficients of variation were 28% and 9%, respectively. The small variation exhibited by the q factor suggested the feasibility of universal q factors for a wide range of body CT protocols.

A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement

PubMed Central

Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

2018-01-01

Objective To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. Methods We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Results Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. Conclusions The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future. PMID:29872509

[Acute Ph-negative lymphoblastic leukemias in adults: Risk factors in the use of the ALL-2009 protocol].

PubMed

Parovichnikova, E N; Sokolov, A N; Troitskaya, V V; Klyasova, G A; Rusinov, M A; Akhmerzaeva, Z Kh; Kuzmina, L A; Bondarenko, S N; Baranova, O Yu; Kaporskaya, T S; Zotina, E N; Zinina, E E; Samoilova, O S; Gavrilova, L V; Kaplanov, K D; Konstantinova, T S; Lapin, V A; Kravchenko, S K; Gribanova, E O; Zvonkov, E E; Gavrilina, O A; Baskhaeva, G A; Galstyan, G M; Obukhova, T N; Galtseva, I V; Kulikov, S M; Savchenko, V G

to analyze well-known risk factors (RFs), such as age, immunophenotype, baseline leukocytosis, enhanced lactate dehydrogenase (LDH) activity, time to achieve complete remission, a risk group, and cytogenetic abnormalities) in patients with acute lymphoblastic leukemia (ALL) in the use of the ALL-2009 protocol. The protocol covered 298 patients (137 women (including 13 pregnant women) and 161 men) aged 15 to 55 years (median age 28 years) with Ph-negative ALL. The phenotype was unknown in 6 patients. Three (1%) were ascertained to have a biphenotypic variant. 182 (62.4%) patients were found to have B-cell ALL (early pre-B ALL (n=51); common ALL (n=92), and pre-B ALL (n=39); 107 (36.6%) patients had T-cell ALL (early T-ALL (n=56); thymic T-ALL (n=41), and mature T-ALL (n=10). According to the baseline clinical and laboratory parameters (leukocytosis of 30·109/l and more for B-ALL; and that of 100·109/l and more for T-ALL; phenotype В-I for B-ALL, phenotype Т-I-II-IV for T-ALL; LDH activity was more than twice the normal values; the presence of translocation t(4;11)), the high-risk group included most patients with B-ALL (n=110 (72.8%)) and T-ALL (n=76 (76%)). Thirty-five patients with T-ALL underwent autologous bone marrow transplantation (BMT). Allogeneic BMT was performed in 18 (7%) of the 258 patients who had undergone an induction phase. Five-year overall survival for all the patients included in the investigation was 59%; relapse-free survival was 65%, which was significantly different in the patients with B-ALL and in those with T-ALL: the overall survival rates were 53.3 and 67.5% (p=0.1); the relapse-free survival was 56 and 79% (p=0.005), respectively. Multivariate analysis including the well-known RFs demonstrated that the latter for T-ALL were of no independent prognostic value and only the patient's age was identified for B-ALL (p=0.013). A lower chemotherapeutic load and a small number of allogeneic BMTs did not affect total positive treatment

The NEIL Memory Research Unit: psychosocial, biological, physiological and lifestyle factors associated with healthy ageing: study protocol.

PubMed

Hannigan, Caoimhe; Coen, Robert F; Lawlor, Brian A; Robertson, Ian H; Brennan, Sabina

2015-01-01

Population ageing is a global phenomenon that has characterised demographic trends during the 20th and 21st century. The rapid growth in the proportion of older adults in the population, and resultant increase in the incidence of age-related cognitive decline, dementia and Alzheimer's disease, brings significant social, economic and healthcare challenges. Decline in cognitive abilities represents the most profound threat to active and healthy ageing. Current evidence suggests that a significant proportion of cases of age-related cognitive decline and dementia may be preventable through the modification of risk factors including education, depressive symptomology, physical activity, social engagement and participation in cognitively stimulating activities. The NEIL Memory Research Unit cohort study was established to investigate factors related to brain health and the maintenance of cognitive function. A cohort of 1000 normally ageing adults aged 50 years and over are being recruited to participate in comprehensive assessments at baseline, and at follow-up once every 2 years. The assessment protocol comprises a comprehensive neuropsychological battery, some basic physical measures, psychosocial scales, questionnaire measures related to a range of health, lifestyle and behavioural factors, and a measure of resting state activity using electroencephalography (EEG). The NEIL Memory Research Unit cohort study will address key questions about brain health and cognitive ageing in the population aged 50+, with a particular emphasis on the influence of potentially modifiable factors on cognitive outcomes. Analyses will be conducted with a focus on factors involved in the maintenance of cognitive function among older adults, and therefore will have the potential to contribute significant knowledge related to key questions within the field of cognitive ageing, and to inform the development of public health interventions aimed at preventing cognitive decline and promoting

Factors influencing psychological, social and health outcomes after major burn injuries in adults: cohort study protocol

PubMed Central

Newcombe, Peter A; Cameron, Cate M; Lipman, Jeffrey

2017-01-01

Introduction The goal of burn care is that ‘the quality of the outcome must be worth the pain of survival’. More research is needed to understand how best to deliver care for patients with burns to achieve this aim. Loss of independence, function as well as loss of income for patients with burns and carers cause a significant burden at both individual and societal levels. Much is being done to advance knowledge in the clinical care field; however, there has been a paucity of research exploring psychosocial outcomes. This paper describes the study background and methods, as implemented in an Australian cohort study of psychosocial outcomes after major burn injuries. Methods and analysis In this inception cohort study, a target sample of 230 participants, aged 18 years or over, admitted to a single statewide burns centre with a burn injury are identified by hospital staff for inclusion. Baseline survey data are collected either in person or by telephone within 28 days of the injury and participants then followed up with telephone interviews at 3, 6 and 12 months postburn. Injury and burns treatment information is collected from medical records. Social support is measured as a predictor variable using the Multidimensional Scale of Perceived Social Support. Outcome data are collected via standardised measures in the domains of Quality of Life (SF-12, EQ-5D, BSHS-B), depression (PHQ-9), post-traumatic stress disorder (PCL-C, PAS), community integration (CIQ-R) and Quality-Adjusted Life Years (EQ-5D). Additional survey questions measure life satisfaction, return to work and public services utilisation at 12 months postinjury. Data analysis methods will include analysis of variance, Pearson correlation and hierarchical multiple regression analyses. Ethics and dissemination Hospital-based and University of Queensland Human Research Ethics Committees have approved the protocol. Results from the study will be disseminated at national and international conferences, in

Efficacy of a Creon delayed-release pancreatic enzyme protocol for clearing occluded enteral feeding tubes.

PubMed

Stumpf, Janice L; Kurian, Rebecca M; Vuong, Jennifer; Dang, Kimberlyn; Kraft, Michael D

2014-04-01

Alkalinized Viokase pancreatic enzyme tablets restored patency to 71.9% of occluded Dobhoff tubes in a prospective study. After removal of Viokase tablets from the US market, the hospital protocol for unclogging enteral feeding tubes was adapted to use Creon pancreatic enzyme delayed-release capsules, despite the lack of published data. To evaluate the effectiveness of a Creon-based protocol to clear occluded enteral feeding tubes. This retrospective study included all adult and pediatric patients seen in the emergency department or in an inpatient setting who received Creon 12 000 units lipase delayed-release capsule dissolved in a solution of sodium bicarbonate 650 mg and sterile water for clearing occluded enteral feeding tubes between May 1 and November 30, 2010. The Creon protocol was deemed effective if tube clearance was documented in the medical record or if enteral feedings were resumed with no note regarding tube replacement. Alkalinized Creon delayed-release capsules were administered to 83 patients with a total of 118 clogged tubes. Three poorly documented cases and 5 tubes with mechanical clogs were excluded from data analysis. Patency was restored to 53 of 110 (48.2%) occluded tubes. More than 1 treatment course was attempted in 5 cases, with success in 3. An alkalinized Creon pancreatic enzyme protocol was effective in clearing approximately half of the occluded enteral feeding tubes in this retrospective study, an efficacy rate much less than that previously reported in the literature with a Viokase-based protocol.

Comparative Study on Various Authentication Protocols in Wireless Sensor Networks.

PubMed

Rajeswari, S Raja; Seenivasagam, V

2016-01-01

Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated.

Comparative Study on Various Authentication Protocols in Wireless Sensor Networks

PubMed Central

Rajeswari, S. Raja; Seenivasagam, V.

2016-01-01

Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated. PMID:26881272

Using mHealth to Increase Treatment Utilization Among Recently Incarcerated Homeless Adults (Link2Care): Protocol for a Randomized Controlled Trial.

PubMed

Reingle Gonzalez, Jennifer M; Businelle, Michael S; Kendzor, Darla; Staton, Michele; North, Carol S; Swartz, Michael

2018-06-05

There is a significant revolving door of incarceration among homeless adults. Homeless adults who receive professional coordination of individualized care (ie, case management) during the period following their release from jail experience fewer mental health and substance use problems, are more likely to obtain stable housing, and are less likely to be reincarcerated. This is because case managers work to meet the various needs of their clients by helping them to overcome barriers to needed services (eg, food, clothing, housing, job training, substance abuse and mental health treatment, medical care, medication, social support, proof of identification, and legal aid). Many barriers (eg, limited transportation, inability to schedule appointments, and limited knowledge of available services) prevent homeless adults who were recently released from incarceration from obtaining available case management, crisis management, substance abuse, and mental health services. The aim of the Link2Care study is to assess the effectiveness of a smartphone app for increasing case management and treatment service utilization, and in turn reduce homelessness and rearrest. The goals of this research are to (1) assess the impact of an innovative smartphone app that will prompt and directly link recently incarcerated homeless adults to community-based case management services and resources and (2) utilize in-person and smartphone-based assessments to identify key variables (eg, alcohol or drug use, social support, psychological distress, and quality of life) that predict continued homelessness and rearrest. Homeless adults (N=432) who enroll in a shelter-based Homeless Recovery Program after release from the Dallas County Jail will be randomly assigned to one of the three treatment groups: (1) usual case management, (2) usual case management plus smartphone, and (3) usual case management with a study-provided smartphone that is preloaded with an innovative case management app

Human Schedule Performance, Protocol Analysis, and the "Silent Dog" Methodology

ERIC Educational Resources Information Center

Cabello, Francisco; Luciano, Carmen; Gomez, Inmaculada; Barnes-Holmes, Dermot

2004-01-01

The purpose of the current experiment was to investigate the role of private verbal behavior on the operant performances of human adults, using a protocol analysis procedure with additional methodological controls (the "silent dog" method). Twelve subjects were exposed to fixed ratio 8 and differential reinforcement of low rate 3-s schedules. For…

Assessment of a web-based Guided Self-Determination intervention for adults with type 2 diabetes in general practice: a study protocol

PubMed Central

Karlsen, Bjørg; Oftedal, Bjørg; Stangeland Lie, Silje; Rokne, Berit; Peyrot, Mark; Zoffmann, Vibeke; Graue, Marit

2016-01-01

Introduction Self-management is deemed the cornerstone in overall diabetes management. Web-based self-management interventions have potential to support adults with type 2 diabetes (T2DM) in managing their disease. Owing to somewhat ambiguous results of such interventions, interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. This study is designed to assess the effectiveness of a theory-driven web-based Guided Self-Determination (GSD) intervention among adults with T2DM in general practice to improve diabetes self-management behaviours and glycosylated haemoglobin (HbA1c). Methods and analysis A complex intervention design based on the framework of the UK Medical Research Council is employed as a guide for developing the intervention, assessing its feasibility and evaluating its effectiveness. The study consists of three phases: (1) the modelling phase adapting the original GSD programme for adults with T2DM, using a qualitative design, (2) feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and (3) evaluating the effectiveness of the intervention on diabetes self-management behaviours and HbA1c, using a quasi-experimental design. The first phase, which is completed, and the second phase, which is underway, will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effectiveness of this systematically developed intervention. Ethics and dissemination The Norwegian Regional Committee for Medical and Health Research Ethics (REK west number 2015/60) has approved the study design. Patients recruited in the different phases will fill out an informed consent form prior to inclusion and will be guaranteed anonymity and the right to withdraw from the study at any time. The results of the study will be published in peer-reviewed journals, electronically and in print

Teaching as a Social Practice: The Experiences of Two Moroccan Adult Literacy Tutors

ERIC Educational Resources Information Center

Erguig, Reddard

2012-01-01

This article offers an ethnographic case study of two Adult Basic Education (ABE) teachers' characteristics and their literacy instruction. It draws on the New Literacy Studies tradition and used ethnographic tools (in-depth interviews, classroom observation and the think-aloud protocol) to explore the characteristics of two ABE teachers and…

Comparison of Head Elevation Protocols Following Femoral Artery Sheath Removal After Coronary Angiography.

PubMed

Olson, Nancy C

2016-06-01

To compare 2 standard protocols for head elevation following removal of a femoral artery sheath after coronary angiography and their effects on bleeding complications and reported levels of back pain. One protocol involved flat supine bed rest; the other allowed progressive head elevation. A prospective comparative study of 80 adult patients undergoing coronary angiography via the femoral approach. The Numeric Rating Scale was used as the measure of reported pain. No bleeding complications occurred in either group. Both groups had very low mean pain scores. Repeated-measures analysis demonstrated that the experience of pain differed significantly over time by location (F5,70 = 3.864, P = .004), with a notable decrease in pain scores more than 1 hour after sheath removal at the location that used the progressive head elevation protocol. Patients' satisfaction scores after discharge did not differ significantly between the 2 groups. Patients with a history of chronic back pain had consistently higher pain scores, but those pain scores did not differ significantly by location (or protocol). It appears that using a progressive head-elevation protocol within the first 3 hours after diagnostic angiography is not associated with an increased risk of bleeding complications at the access site and warrants further exploration in the mitigation of back pain associated with prolonged supine bed rest. ©2016 American Association of Critical-Care Nurses.

Diet Quality and Cancer Outcomes in Adults: A Systematic Review of Epidemiological Studies

PubMed Central

Potter, Jennifer; Brown, Leanne; Williams, Rebecca L.; Byles, Julie; Collins, Clare E.

2016-01-01

Dietary patterns influence cancer risk. However, systematic reviews have not evaluated relationships between a priori defined diet quality scores and adult cancer risk and mortality. The aims of this systematic review are to (1) describe diet quality scores used in cohort or cross-sectional research examining cancer outcomes; and (2) describe associations between diet quality scores and cancer risk and mortality. The protocol was registered in Prospero, and a systematic search using six electronic databases was conducted through to December 2014. Records were assessed for inclusion by two independent reviewers, and quality was evaluated using a validated tool. Sixty-four studies met inclusion criteria from which 55 different diet quality scores were identified. Of the 35 studies investigating diet quality and cancer risk, 60% (n = 21) found a positive relationship. Results suggest no relationship between diet quality scores and overall cancer risk. Inverse associations were found for diet quality scores and risk of postmenopausal breast, colorectal, head, and neck cancer. No consistent relationships between diet quality scores and cancer mortality were found. Diet quality appears to be related to site-specific adult cancer risk. The relationship with cancer mortality is less conclusive, suggesting additional factors impact overall cancer survival. Development of a cancer-specific diet quality score for application in prospective epidemiology and in public health is warranted. PMID:27399671

NATURAL HISTORY OF DENTAL PLAQUE ACCUMULATION IN MECHANICALLY VENTILATED ADULTS: A DESCRIPTIVE CORRELATIONAL STUDY

PubMed Central

Jones, Deborah J.; Munro, Cindy L.; Grap, Mary Jo

2011-01-01

Summary Objective The purpose of this study was to describe the pattern of dental plaque accumulation in mechanically ventilated adults. Accumulation of dental plaque and bacterial colonization of the oropharynx is associated with a number of systemic diseases including ventilator associated pneumonia. Research Methodology/Design Data were collected from mechanically ventilated critically ill adults (n=137), enrolled within 24 hours of intubation. Dental plaque, counts of decayed, missing and filled teeth and systemic antibiotic use was assessed on study days 1, 3, 5 and 7. Dental plaque averages per study day, tooth type and tooth location were analyzed. Setting Medical Respiratory, Surgical Trauma and Neuroscience ICU’s of a large tertiary care center in the southeast United States. Results Plaque: All surfaces > 60% plaque coverage from day 1 to day 7; Molars and Premolars contained greatest plaque average >70%. Systemic antibiotic use on day 1 had no significant effect on plaque accumulation on day 3 (p=0.73). Conclusions Patients arrive in critical care units with preexisting oral hygiene issues. Dental plaque tends to accumulate in the posterior teeth (molars and premolars) that may be hard for nurses to visualize and reach; this problem may be exacerbated by endotracheal tubes and other equipment. Knowing accumulation trends of plaque will guide the development of effective oral care protocols. PMID:22014582

The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation.

PubMed

Lelijveld, Natasha; Bailey, Jeanette; Mayberry, Amy; Trenouth, Lani; N'Diaye, Dieynaba S; Haghparast-Bidgoli, Hassan; Puett, Chloe

2018-04-24

Acute malnutrition is currently divided into severe (SAM) and moderate (MAM) based on level of wasting. SAM and MAM currently have separate treatment protocols and products, managed by separate international agencies. For SAM, the dose of treatment is allocated by the child's weight. A combined and simplified protocol for SAM and MAM, with a standardised dose of ready-to-use therapeutic food (RUTF), is being trialled for non-inferior recovery rates and may be more cost-effective than the current standard protocols for treating SAM and MAM. This is the protocol for the economic evaluation of the ComPAS trial, a cluster-randomised controlled, non-inferiority trial that compares a novel combined protocol for treating uncomplicated acute malnutrition compared to the current standard protocol in South Sudan and Kenya. We will calculate the total economic costs of both protocols from a societal perspective, using accounting data, interviews and survey questionnaires. The incremental cost of implementing the combined protocol will be estimated, and all costs and outcomes will be presented as a cost-consequence analysis. Incremental cost-effectiveness ratio will be calculated for primary and secondary outcome, if statistically significant. We hypothesise that implementing the combined protocol will be cost-effective due to streamlined logistics at clinic level, reduced length of treatment, especially for MAM, and reduced dosages of RUTF. The findings of this economic evaluation will be important for policymakers, especially given the hypothesised non-inferiority of the main health outcomes. The publication of this protocol aims to improve rigour of conduct and transparency of data collection and analysis. It is also intended to promote inclusion of economic evaluation in other nutrition intervention studies, especially for MAM, and improve comparability with other studies. ISRCTN 30393230 , date: 16/03/2017.

Using music to reduce anxiety among older adults in the emergency department: a randomized pilot study.

PubMed

Belland, Laura; Rivera-Reyes, Laura; Hwang, Ula

2017-11-01

An emergency department (ED) visit may be distressing and anxiety-provoking for older adults (age > 65 years). No studies have specifically evaluated the effect of music listening on anxiety in older adults in the ED. The objective of this pilot study was to evaluate the effect of music listening on anxiety levels in older ED patients. This was a randomized pilot study in the geriatric ED of an urban academic tertiary medical center. This was a sample of English-speaking adults (age > 65 years) who were not deaf (n = 35). Subjects consented to participate and were randomized to receive up to 60 min of music listening with routine care, while the control group received routine care with no music. Subjects in the music treatment group received headphones and an electronic tablet with pre-downloaded music, and were allowed to choose from 5 selections. The primary outcome was change in anxiety levels, measured by the state-trait anxiety inventory (STAI), at enrollment and 1 h later. A total of 35 participants were enrolled: 74% were female, 40% were white, and 40% were black; of these, 32 subjects completed the study protocol. When comparing control (n = 18) against intervention subjects (n = 17), there were no significant differences in enrollment STAI scores (43.00 ± 15.00 vs. 40.30 ± 12.80, P = 0.57). STAI scores 1 hour after enrollment (after the music intervention) were significantly reduced in the intervention subjects compared to the control subjects (with reduction of 10.00 ± 12.29 vs. 1.88 ± 7.97, P = 0.03). These pilot results suggest that music listening may be an effective tool for reducing anxiety among older adults in the ED.

Intra-protocol repeatability and inter-protocol agreement for the analysis of scapulo-humeral coordination.

PubMed

Parel, I; Cutti, A G; Kraszewski, A; Verni, G; Hillstrom, H; Kontaxis, A

2014-03-01

Multi-center clinical trials incorporating shoulder kinematics are currently uncommon. The absence of repeatability and limits of agreement (LoA) studies between different centers employing different motion analysis protocols has led to a lack dataset compatibility. Therefore, the aim of this work was to determine the repeatability and LoA between two shoulder kinematic protocols. The first one uses a scapula tracker (ST), the International Society of Biomechanics anatomical frames and an optoelectronic measurement system, and the second uses a spine tracker, the INAIL Shoulder and Elbow Outpatient protocol (ISEO) and an inertial and magnetic measurement system. First within-protocol repeatability for each approach was assessed on a group of 23 healthy subjects and compared with the literature. Then, the between-protocol agreement was evaluated. The within-protocol repeatability was similar for the ST ([Formula: see text] = 2.35°, [Formula: see text] = 0.97°, SEM = 2.5°) and ISEO ([Formula: see text] = 2.24°, [Formula: see text] = 0.97°, SEM = 2.3°) protocols and comparable with data from published literature. The between-protocol agreement analysis showed comparable scapula medio-lateral rotation measurements for up to 120° of flexion-extension and up to 100° of scapula plane ab-adduction. Scapula protraction-retraction measurements were in agreement for a smaller range of humeral elevation. The results of this study suggest comparable repeatability for the ST and ISEO protocols and between-protocol agreement for two scapula rotations. Different thresholds for repeatability and LoA may be adapted to suit different clinical hypotheses.

Spinal versus general anaesthesia in surgery for inguinodynia (SPINASIA trial): study protocol for a randomised controlled trial.

PubMed

Zwaans, Willem A R; le Mair, Léon H P M; Scheltinga, Marc R M; Roumen, Rudi M H

2017-01-14

Chronic inguinodynia (groin pain) is a common complication following open inguinal hernia repair or a Pfannenstiel incision but may also be experienced after other types of (groin) surgery. If conservative treatments are to no avail, tailored remedial surgery, including a neurectomy and/or a (partial) meshectomy, may be considered. Retrospective studies in patients with chronic inguinodynia suggested that spinal anaesthesia is superior compared to general anaesthesia in terms of pain relief following remedial operations. This randomised controlled trial is designed to study the effect of type of anaesthesia (spinal or general) on pain relief following remedial surgery for inguinodynia. A total of 190 adult patients who suffer from unacceptable chronic (more than 3 months) inguinodynia, as subjectively judged by the patients themselves, are included. Only patients scheduled to undergo a neurectomy and/or a meshectomy by an open approach are considered for inclusion and randomised to spinal or general anaesthesia. Patients are excluded if pain is attributable to abdominal causes or if any contraindications for either type of anaesthesia are present. Primary outcome is effect of type of anaesthesia on pain relief. Secondary outcomes include patient satisfaction, quality of life, use of analgesics and (in)direct medical costs. Patient follow-up period is one year. The first patient was included in January 2016. The expected trial deadline is December 2019. Potential effects are deemed related to the entire setting of type of anaesthesia. Since any setting is multifactorial, all of these factors may influence the outcome measures. This is the first large randomised controlled trial comparing the two most frequently used anaesthetic techniques in remedial surgery for groin pain. There is a definite need for evidence-based strategies to optimise results of these types of surgery. Besides pain relief, other important patient-related outcome measures are assessed to

Effects of zinc supplementation on obesity: study protocol for a randomized controlled clinical trial.

PubMed

Rathnayake, Kumari M; Silva, Kdrr; Jayawardena, Ranil

2016-11-04

The prevalence of obesity is escalating alarmingly worldwide, and it is now becoming a rapidly growing epidemic in developing countries. Recent studies have reported that zinc has been implicated in altered lipid markers, insulin resistance and some obesity markers. There is a lack of evidence on zinc as a potential therapeutic agent to reduce weight and improve metabolic parameters in obese adults. The present study is designed to evaluate the effects of zinc supplementation on obese adults in Sri Lanka. Furthermore, we aim to evaluate the effects of zinc supplementation on metabolic parameters in this population. This study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 3 months at the clinical laboratory, Department of Applied Nutrition, Wayamba University of Sri Lanka to assess the efficacy of daily zinc 20 mg supplementation in obese subjects. There will be a total of 80 subjects, aged between 18-60 years, of both genders, who are obese (body mass index (BMI) ≥25). Subjects will be stratified according to age, gender and BMI and randomly assigned into the test and placebo groups in a 1:1 ratio. The treatment drug is a capsule containing elemental zinc 20 mg as the active ingredient (as zinc sulphate). The placebo capsule will contain lactose monohydrate. The subjects will receive either zinc capsules or placebo daily for 3 months. The study treatments will be double blinded to both investigator and subject. The visits and the evaluations will be as follows: screening (visit 0), baseline (visit 1) and 3 month (visit 2). The primary outcome will be weight reduction among the obese subjects. Secondary outcome measures include glycaemic status (fasting blood glucose), lipid parameters (total cholesterol, triglyceride levels, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) and blood pressure. The trial protocol will aim to establish the effects of zinc supplementation on weight

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

PubMed

Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2014-07-16

To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis.

PubMed

Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

2018-01-01

The concept of the risk-based approach has been introduced as an effort to secure the quality of clinical trials. In the risk-based approach, identification and evaluation of risk in advance are considered important. For recently completed clinical trials, we investigated the relationship between study characteristics and protocol deviations leading to the exclusion of subjects from Per Protocol Set (PPS) efficacy analysis. New drugs approved in Japan in the fiscal year 2014-2015 were targeted in the research. The reasons for excluding subjects from the PPS efficacy analysis were described in 102 trials out of 492 in the summary of new drug application documents, which was publicly disclosed after the drug's regulatory approval. The author extracted these reasons along with the numbers of the cases and the study characteristics of each clinical trial. Then, the direct comparison, univariate regression analysis, and multivariate regression analysis was carried out based on the exclusion rate. The study characteristics for which exclusion of subjects from the PPS efficacy analysis were frequently observed was multiregional clinical trials in study region; inhalant and external use in administration route; Anti-infective for systemic use; Respiratory system, Dermatologicals, and Nervous system in therapeutic drug under the Anatomical Therapeutic Chemical Classification. In the multivariate regression analysis, the clinical trial variables of inhalant, Respiratory system, or Dermatologicals were selected as study characteristics leading to a higher exclusion rate. The characteristics of the clinical trial that is likely to cause protocol deviations that will affect efficacy analysis were suggested. These studies should be considered for specific attention and priority observation in the trial protocol or its monitoring plan and execution, such as a clear description of inclusion/exclusion criteria in the protocol, development of training materials to site staff, and

Safety and Utility of Quantitative Sensory Testing among Adults with Sickle Cell Disease: Indicators of Neuropathic Pain?

PubMed Central

Ezenwa, Miriam O.; Molokie, Robert E.; Wang, Zaijie Jim; Yao, Yingwei; Suarez, Marie L.; Pullum, Cherese; Schlaeger, Judith M.; Fillingim, Roger B.; Wilkie, Diana J.

2014-01-01

Objectives Pain is the hallmark symptom of sickle cell disease (SCD), yet the types of pain that these patients experience, and the underlying mechanisms, have not been well characterized. The study purpose was to determine the safety and utility of a mechanical and thermal quantitative sensory testing (QST) protocol and the feasibility of utilizing neuropathic pain questionnaires among adults with SCD. Methods A convenience sample (N=25, 18 women, mean age 38.5 ± 12.5 [20–58 years]) completed self-report pain and quality-of-life tools. Subjects also underwent testing with the TSA-II NeuroSensory Analyzer and calibrated von Frey microfilaments. Results We found that the QST protocol was safe and did not stimulate a SCD pain crisis. There was evidence of central sensitization (n=15), peripheral sensitization (n=1), a mix of central and peripheral sensitization (n=8), or no sensitization (n=1). The neuropathic pain self-report tools were feasible with evidence of construct validity; 40% of the subjects reported S-LANSS scores that were indicative of neuropathic pain and had evidence of central, peripheral or mixed sensitization. Discussion The QST protocol can be safely conducted in adults with SCD and provides evidence of central or peripheral sensitization, which is consistent with a neuropathic component to SCD pain. These findings are novel, warrant a larger confirmatory study, and indicate the need for normative QST data from African American adults and older adults. PMID:25581383

Outcomes of an extended-infusion piperacillin-tazobactam protocol implementation in a community teaching hospital adult intensive care unit.

PubMed

Schmees, Patrick M; Bergman, Scott J; Strader, Brandi D; Metzke, Megan E; Pointer, Sarah; Valenti, Kristine M

2016-06-01

The purpose of this study is to evaluate the outcome differences between patients receiving piperacillin-tazobactam pre- and post-implementation of an extended infusion dosing protocol in a community teaching hospital adult intensive care unit. On December 19th, 2011, extended infusion dosing of piperacillin-tazobactam was implemented at St. John's Hospital's intensive and cardiac care units (ICU/CCU) following IRB-approval. This is a historical case-control cohort study involving review of electronic medical charts of patients who received traditional or extended infusion therapy. Data was collected for patients that received piperacillin-tazobactam in the ICU/CCU from December 19th, 2010 through March 19th, 2011 for traditional infusion and from December 19th, 2011 through March 19th, 2012 for extended infusion. Primary endpoints were ICU/CCU mortality at discharge and length of stay. The study included 113 patients with 52 in the traditional-infusion group and 61 extended-infusion group. There was no statistically significant difference in the primary end-point of ICU/CCU mortality between the two groups (14.8% vs. 21.1%; p = 0.374). In the extended infusion group, there was a shorter length of ICU and CCU stay (8.32 vs. 12.06 days; p = 0.025) and shorter length of hospital stay (11.32 vs. 19.7 days; p = 0.006). The extended-infusion group showed a decrease in cost of therapy that was statistically significant ($120.21 vs. $155.17; p = 0.035). Adverse drug effects did not differ between the two study groups. This study showed that treatment with extended-infusion piperacillin-tazobactam therapy improved patient outcomes while maintaining patient safety and decreasing costs. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

A comparative study of two protocols for treadmill walking exercise testing in ambulating subjects with incomplete spinal cord injury.

PubMed

Lundgaard, E; Wouda, M F; Strøm, V

2017-10-01

This is a comparative study of two exercise testing protocols. The objective of this study was to compare maximal oxygen uptake (VO 2 max) and achieved criteria for maximal exercise testing between the Sunnaas Protocol-a newly designed treadmill exercise test protocol-and the Modified Bruce Protocol in persons with incomplete spinal cord injury (SCI). This study was conducted in Sunnaas Rehabilitation Hospital, Norway. Twenty persons (19 men) with incomplete SCI (AIS D) capable of ambulating without assistive devices performed two treadmill walking exercise tests (Sunnaas Protocol and Modified Bruce Protocol) until exhaustion 1-3 days apart. The key differences between the protocols are the smaller increments in speed and shorter duration on each workload in the Sunnaas Protocol. Cardiovascular responses were measured continuously throughout both tests. The subjects exhibited statistically significantly higher VO 2 max when using the Sunnaas Protocol (37.1±9.9 vs 35.4±9.8 ml kg -1  min -1 , P=0.01), with a mean between-test difference of 1.8 ml kg -1  min -1 (95% confidence interval: 0.49-3.16). There was no significant difference in mean maximal heart rate (HR max). Nineteen (95%) subjects achieved at least three of the four criteria for maximal oxygen uptake using the Sunnaas Protocol. Thirteen (65%) subjects achieved at least three of the criteria using a Modified Bruce protocol. The small differences in both VO 2 max and achieved criteria in favor of the Sunnaas Protocol suggest that it could be a useful alternative treadmill exercise test protocol for ambulating persons with incomplete SCI.

Neighbourhood environment, physical activity, quality of life and depressive symptoms in Hong Kong older adults: a protocol for an observational study.

PubMed

Cerin, Ester; Sit, Cindy H P; Zhang, Casper J P; Barnett, Anthony; Cheung, Martin M C; Lai, Poh-Chin; Johnston, Janice M; Lee, Ruby S Y

2016-01-05

The neighbourhood environment can assist the adoption and maintenance of an active lifestyle and affect the physical and mental well-being of older adults. The psychosocial and behavioural mechanisms through which the environment may affect physical and mental well-being are currently poorly understood. This observational study aims to examine associations between the physical and social neighbourhood environments, physical activity, quality of life and depressive symptoms in Chinese Hong Kong older adults. An observational study of the associations of measures of the physical and social neighbourhood environment, and psychosocial factors, with physical activity, quality of life and depressive symptoms in 900 Hong Kong older adults aged 65+ years is being conducted in 2012-2016. The study involves two assessments taken 6 months apart. Neighbourhood walkability and access to destinations are objectively measured using Geographic Information Systems and environmental audits. Demographics, socioeconomic status, walking for different purposes, perceived neighbourhood and home environments, psychosocial factors, health status, social networks, depressive symptoms and quality of life are being assessed using validated interviewer-administered self-report measures and medical records. Physical functionality is being assessed using the Short Physical Performance Battery. Physical activity and sedentary behaviours are also being objectively measured in approximately 45% of participants using accelerometers over a week. Physical activity, sedentary behaviours, quality of life and depressive symptoms are being assessed twice (6 months apart) to examine seasonality effects on behaviours and their associations with quality of life and depressive symptoms. The study received ethical approval from the University of Hong Kong Human Research Ethics Committee for Non-Clinical Faculties (EA270211) and the Department of Health (Hong Kong SAR). Data are stored in a password

What parental characteristics can predict child maltreatment at the Emergency Department? Considering expansion of the Hague Protocol.

PubMed

Diderich, Hester M; Dechesne, Mark; Fekkes, Minne; Verkerk, Paul H; Buitendijk, Simone E; Oudesluys-Murphy, Anne-Marie

2015-08-01

The Hague Protocol considers three parental characteristics of Emergency Department adult patients to identify child abuse: (a) domestic violence, (b) intoxication, and (c) suicide attempt or auto mutilation. This study investigated whether additional parental characteristics could be included to improve the chance of detection. Using a nested case-control design, we compared parents identified as child abusers who were missed by the Protocol with a matched group of nonabusing parents. The parental characteristics used were, among others, all physical injuries possibly resulting from domestic violence, psychological, or mental complaints that might indicate elevated domestic stress levels and the number of Emergency Department visits during the previous year. None of the characteristics were statistically significantly associated with child abuse. The Hague Protocol will not be improved by adding one or more of the characteristics that were investigated.

Data resource profile: the World Health Organization Study on global AGEing and adult health (SAGE).

PubMed

Kowal, Paul; Chatterji, Somnath; Naidoo, Nirmala; Biritwum, Richard; Fan, Wu; Lopez Ridaura, Ruy; Maximova, Tamara; Arokiasamy, Perianayagam; Phaswana-Mafuya, Nancy; Williams, Sharon; Snodgrass, J Josh; Minicuci, Nadia; D'Este, Catherine; Peltzer, Karl; Boerma, J Ties

2012-12-01

Population ageing is rapidly becoming a global issue and will have a major impact on health policies and programmes. The World Health Organization's Study on global AGEing and adult health (SAGE) aims to address the gap in reliable data and scientific knowledge on ageing and health in low- and middle-income countries. SAGE is a longitudinal study with nationally representative samples of persons aged 50+ years in China, Ghana, India, Mexico, Russia and South Africa, with a smaller sample of adults aged 18-49 years in each country for comparisons. Instruments are compatible with other large high-income country longitudinal ageing studies. Wave 1 was conducted during 2007-2010 and included a total of 34 124 respondents aged 50+ and 8340 aged 18-49. In four countries, a subsample consisting of 8160 respondents participated in Wave 1 and the 2002/04 World Health Survey (referred to as SAGE Wave 0). Wave 2 data collection will start in 2012/13, following up all Wave 1 respondents. Wave 3 is planned for 2014/15. SAGE is committed to the public release of study instruments, protocols and meta- and micro-data: access is provided upon completion of a Users Agreement available through WHO's SAGE website (www.who.int/healthinfo/systems/sage) and WHO's archive using the National Data Archive application (http://apps.who.int/healthinfo/systems/surveydata).

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

PubMed Central

2014-01-01

This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. PMID:24980283

Implementation of Symptom Protocols for Nurses Providing Telephone‐Based Cancer Symptom Management: A Comparative Case Study

PubMed Central

Green, Esther; Ballantyne, Barbara; Tarasuk, Joy; Skrutkowski, Myriam; Carley, Meg; Chapman, Kim; Kuziemsky, Craig; Kolari, Erin; Sabo, Brenda; Saucier, Andréanne; Shaw, Tara; Tardif, Lucie; Truant, Tracy; Cummings, Greta G.; Howell, Doris

2016-01-01

ABSTRACT Background The pan‐Canadian Oncology Symptom Triage and Remote Support (COSTaRS) team developed 13 evidence‐informed protocols for symptom management. Aim To build an effective and sustainable approach for implementing the COSTaRS protocols for nurses providing telephone‐based symptom support to cancer patients. Methods A comparative case study was guided by the Knowledge to Action Framework. Three cases were created for three Canadian oncology programs that have nurses providing telephone support. Teams of researchers and knowledge users: (a) assessed barriers and facilitators influencing protocol use, (b) adapted protocols for local use, (c) intervened to address barriers, (d) monitored use, and (e) assessed barriers and facilitators influencing sustained use. Analysis was within and across cases. Results At baseline, >85% nurses rated protocols positively but barriers were identified (64‐80% needed training). Patients and families identified similar barriers and thought protocols would enhance consistency among nurses teaching self‐management. Twenty‐two COSTaRS workshops reached 85% to 97% of targeted nurses (N = 119). Nurses felt more confident with symptom management and using the COSTaRS protocols (p < .01). Protocol adaptations addressed barriers (e.g., health records approval, creating pocket versions, distributing with telephone messages). Chart audits revealed that protocols used were documented for 11% to 47% of patient calls. Sustained use requires organizational alignment and ongoing leadership support. Linking Evidence to Action Protocol uptake was similar to trials that have evaluated tailored interventions to improve professional practice by overcoming identified barriers. Collaborating with knowledge users facilitated interpretation of findings, aided protocol adaptation, and supported implementation. Protocol implementation in nursing requires a tailored approach. A multifaceted intervention approach increased nurses’ use

Hypertension study in anaesthetized rabbits: protocol proposal for AT1 antagonists screening.

PubMed

Politi, Aggeliki P; Zervou, Maria V; Triantafyllidi, Helen; Zoumpoulakis, Panagiotis G; Mavromoustakos, Thomas M; Zoga, Anastasia A; Moutevelis-Minakakis, Panagiota; Kokotos, George; Iliodromitis, Efstathios K; Kremastinos, Dimitris Th

2010-06-01

The aim of this study was to establish an optimized fast and safe protocol for the pharmacological screening of AT(1) antagonists. The pharmaceutical prototype AT(1) antagonist losartan, its active metabolite EXP3174 and the synthetic compound MMK1 were analysed in order to validate the protocol. Ang II was continuously infused while the animals received the drugs in two procedures. In the post-treatment procedure drugs were administered either in a single bolus dose or in a sequential manner. When losartan was administered in a single bolus dose, efficacy was evident until the 7th min (p=0.012) whilst EXP3174 infusion extended the efficiency up to the end of the study (p=0.006). In addition, the sequential injections of losartan prolonged the inhibitory time interval until the end of the study (p=0.045). In the pre-treatment procedure, results suggested a dose-dependent inhibitory effect for both antagonists. The pressor response to Ang II was unchanged after MMK1 administration either in the post- or in the pre-treatment mode. The proposed protocol appears to be safe, simple and fast for the pharmacological screening of AT(1) antagonists and enables the evaluation of new antagonists using lower doses than any other reported in the literature.

Evaluation of Vitamin D Standardization Program protocols for standardizing serum 25-hydroxyvitamin D data: a case study of the program's potential for national nutrition and health surveys12345

PubMed Central

Cashman, Kevin D; Kiely, Mairead; Kinsella, Michael; Durazo-Arvizu, Ramón A; Tian, Lu; Zhang, Yue; Lucey, Alice; Flynn, Albert; Gibney, Michael J; Vesper, Hubert W; Phinney, Karen W; Coates, Paul M; Picciano, Mary F; Sempos, Christopher T

2013-01-01

Background: The Vitamin D Standardization Program (VDSP) has developed protocols for standardizing procedures of 25-hydroxyvitamin D [25(OH)D] measurement in National Health/Nutrition Surveys to promote 25(OH)D measurements that are accurate and comparable over time, location, and laboratory procedure to improve public health practice. Objective: We applied VDSP protocols to existing ELISA-derived serum 25(OH)D data from the Irish National Adult Nutrition Survey (NANS) as a case-study survey and evaluated their effectiveness by comparison of the protocol-projected estimates with those from a reanalysis of survey serums by using liquid chromatography–tandem mass spectrometry (LC–tandem MS). Design: The VDSP reference system and protocols were applied to ELISA-based serum 25(OH)D data from the representative NANS sample (n = 1118). A reanalysis of 99 stored serums by using standardized LC–tandem MS and resulting regression equations yielded predicted standardized serum 25(OH)D values, which were then compared with LC–tandem MS reanalyzed values for all serums. Results: Year-round prevalence rates for serum 25(OH)D concentrations <30, <40, and <50 nmol/L were 6.5%, 21.9%, and 40.0%, respectively, via original ELISA measurements and 11.4%, 25.3%, and 43.7%, respectively, when VDSP protocols were applied. Differences in estimates at <30- and <40-nmol/L thresholds, but not at the <50-nmol/L threshold, were significant (P < 0.05). A reanalysis of all serums by using LC–tandem MS confirmed prevalence estimates as 11.2%, 27.2%, and 45.0%, respectively. Prevalences of serum 25(OH)D concentrations >125 nmol/L were 1.2%, 0.3%, and 0.6% by means of ELISA, VDSP protocols, and LC–tandem MS, respectively. Conclusion: VDSP protocols hold a major potential for national nutrition and health surveys in terms of the standardization of serum 25(OH)D data. PMID:23615829

Implicit Attitudes of International and American Adult Students toward Black and White Teachers

ERIC Educational Resources Information Center

Na, Eunkyung; Tan, Tony X.; Marn, Travis; Ramirez, Rica

2015-01-01

The purpose of this study was to examine hidden prejudice in two groups of adult students, international and American, against black compared to white teachers. Social desirability in the minds of participants may affect the result of a study involving racial bias (Mullins, 1982). For this reason, the researchers created a computer protocol using…

Prevalence of obesity in attention-deficit/hyperactivity disorder: study protocol for a systematic review and meta-analysis.

PubMed

Cortese, Samuele; Moreira Maia, Carlos Renato; Rohde, Luis Augusto; Morcillo-Peñalver, Carmen; Faraone, Stephen V

2014-03-18

An increasing number of clinical and epidemiological studies suggest a possible association between attention-deficit/hyperactivity disorder (ADHD) and obesity/overweight. However, overall evidence is mixed. Given the public health relevance of ADHD and obesity/overweight, understanding whether and to what extent they are associated is paramount to plan intervention and prevention strategies. We describe the protocol of a systematic review and meta-analysis aimed at assessing the prevalence of obesity/overweight in individuals with ADHD versus those without ADHD. We will include studies of any design (except case reports or case series) comparing the prevalence of obesity and/or overweight in children or adults with and without ADHD (or hyperkinetic disorder). We will search an extensive number of databases including PubMed, Ovid databases, Web of Knowledge and Thomson-Reuters databases, ERIC and CINAHL. No restrictions of language will be applied. We will also contact experts in the field for possible unpublished or in press data. Primary and additional outcomes will be the prevalence of obesity and overweight, respectively. We will combine ORs using random-effects models in STATA V.12.0. The quality of the study will be assessed primarily using the Newcastle-Ottawa Scale. Subgroup meta-analyses will be conducted according to participants' age (children vs adults) and study setting (clinical vs general population). We will explore the feasibility of conducting meta-regression analyses to assess the moderating effect of age, gender, socioeconomic status, study setting, geographic location of the study (low-income, middle-income countries vs high-income countries), definition of obesity, method to assess ADHD, psychiatric comorbidities and medication status. No ethical issues are foreseen. The results will be published in a peer-reviewed journal and presented at national and international conferences of psychiatry, psychology, obesity and paediatrics. PROSPERO

[The research protocol III. Study population].

PubMed

Arias-Gómez, Jesús; Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

2016-01-01

The study population is defined as a set of cases, determined, limited, and accessible, that will constitute the subjects for the selection of the sample, and must fulfill several characteristics and distinct criteria. The objectives of this manuscript are focused on specifying each one of the elements required to make the selection of the participants of a research project, during the elaboration of the protocol, including the concepts of study population, sample, selection criteria and sampling methods. After delineating the study population, the researcher must specify the criteria that each participant has to comply. The criteria that include the specific characteristics are denominated selection or eligibility criteria. These criteria are inclusion, exclusion and elimination, and will delineate the eligible population. The sampling methods are divided in two large groups: 1) probabilistic or random sampling and 2) non-probabilistic sampling. The difference lies in the employment of statistical methods to select the subjects. In every research, it is necessary to establish at the beginning the specific number of participants to be included to achieve the objectives of the study. This number is the sample size, and can be calculated or estimated with mathematical formulas and statistic software.

Physiotherapy to improve physical activity in community-dwelling older adults with mobility problems (Coach2Move): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Older adults can benefit from physical activity in numerous ways. Physical activity is considered to be one of the few ways to influence the level of frailty. Standardized exercise programs do not necessarily lead to more physical activity in daily life, however, and a more personalized approach seems appropriate. The main objective of this study is to investigate whether a focused, problem-oriented coaching intervention (‘Coach2Move’) delivered by a physiotherapist specializing in geriatrics is more effective for improving physical activity, mobility and health status in community-dwelling older adults than usual physiotherapy care. In addition, cost-effectiveness will be determined. Methods/Design The design of this study is a single-blind randomized controlled trial in thirteen physiotherapy practices. Randomization will take place at the individual patient level. The study population consists of older adults, ≥70 years of age, with decreased physical functioning and mobility and/or a physically inactive lifestyle. The intervention group will receive geriatric physiotherapy according to the Coach2Move strategy. The control group will receive the usual physiotherapy care. Measurements will be performed by research assistants not aware of group assignment. The results will be evaluated on the amount of physical activity (LASA Physical Activity Questionnaire), mobility (modified ‘get up and go’ test, walking speed and six-minute walking test), quality of life (SF-36), degree of frailty (Evaluative Frailty Index for Physical Activity), fatigue (NRS-fatigue), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire) and health care costs. Discussion Most studies on the effect of exercise or physical activity consist of standardized programs. In this study, a personalized approach is evaluated within a group of frail older adults, many of whom suffer from multiple and complex diseases and problems. A complicating

Physiotherapy to improve physical activity in community-dwelling older adults with mobility problems (Coach2Move): study protocol for a randomized controlled trial.

PubMed

de Vries, Nienke M; Staal, J Bart; Teerenstra, Steven; Adang, Eddy M M; Rikkert, Marcel G M Olde; Nijhuis-van der Sanden, Maria W G

2013-12-17

Older adults can benefit from physical activity in numerous ways. Physical activity is considered to be one of the few ways to influence the level of frailty. Standardized exercise programs do not necessarily lead to more physical activity in daily life, however, and a more personalized approach seems appropriate. The main objective of this study is to investigate whether a focused, problem-oriented coaching intervention ('Coach2Move') delivered by a physiotherapist specializing in geriatrics is more effective for improving physical activity, mobility and health status in community-dwelling older adults than usual physiotherapy care. In addition, cost-effectiveness will be determined. The design of this study is a single-blind randomized controlled trial in thirteen physiotherapy practices. Randomization will take place at the individual patient level. The study population consists of older adults, ≥70 years of age, with decreased physical functioning and mobility and/or a physically inactive lifestyle. The intervention group will receive geriatric physiotherapy according to the Coach2Move strategy. The control group will receive the usual physiotherapy care. Measurements will be performed by research assistants not aware of group assignment. The results will be evaluated on the amount of physical activity (LASA Physical Activity Questionnaire), mobility (modified 'get up and go' test, walking speed and six-minute walking test), quality of life (SF-36), degree of frailty (Evaluative Frailty Index for Physical Activity), fatigue (NRS-fatigue), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire) and health care costs. Most studies on the effect of exercise or physical activity consist of standardized programs. In this study, a personalized approach is evaluated within a group of frail older adults, many of whom suffer from multiple and complex diseases and problems. A complicating factor in evaluating a new approach is that it

Factors influencing psychological, social and health outcomes after major burn injuries in adults: cohort study protocol.

PubMed

Druery, Martha; Newcombe, Peter A; Cameron, Cate M; Lipman, Jeffrey

2017-06-17

The goal of burn care is that 'the quality of the outcome must be worth the pain of survival'. More research is needed to understand how best to deliver care for patients with burns to achieve this aim. Loss of independence, function as well as loss of income for patients with burns and carers cause a significant burden at both individual and societal levels. Much is being done to advance knowledge in the clinical care field; however, there has been a paucity of research exploring psychosocial outcomes. This paper describes the study background and methods, as implemented in an Australian cohort study of psychosocial outcomes after major burn injuries. In this inception cohort study, a target sample of 230 participants, aged 18 years or over, admitted to a single statewide burns centre with a burn injury are identified by hospital staff for inclusion. Baseline survey data are collected either in person or by telephone within 28 days of the injury and participants then followed up with telephone interviews at 3, 6 and 12 months postburn. Injury and burns treatment information is collected from medical records. Social support is measured as a predictor variable using the Multidimensional Scale of Perceived Social Support. Outcome data are collected via standardised measures in the domains of Quality of Life (SF-12, EQ-5D, BSHS-B), depression (PHQ-9), post-traumatic stress disorder (PCL-C, PAS), community integration (CIQ-R) and Quality-Adjusted Life Years (EQ-5D). Additional survey questions measure life satisfaction, return to work and public services utilisation at 12 months postinjury. Data analysis methods will include analysis of variance, Pearson correlation and hierarchical multiple regression analyses. Hospital-based and University of Queensland Human Research Ethics Committees have approved the protocol. Results from the study will be disseminated at national and international conferences, in peer-reviewed journals and in a doctoral thesis. Australia New

Low tube voltage dual source computed tomography to reduce contrast media doses in adult abdomen examinations: A phantom study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Thor, Daniel; Brismar, Torkel B., E-mail: torkel.brismar@gmail.com; Fischer, Michael A.

Purpose: To evaluate the potential of low tube voltage dual source (DS) single energy (SE) and dual energy (DE) computed tomography (CT) to reduce contrast media (CM) dose in adult abdominal examinations of various sizes while maintaining soft tissue and iodine contrast-to-noise ratio (CNR). Methods: Four abdominal phantoms simulating a body mass index of 16 to 35 kg/m{sup 2} with four inserted syringes of 0, 2, 4, and 8 mgI/ml CM were scanned using a 64-slice DS-CT scanner. Six imaging protocols were used; one single source (SS) reference protocol (120 kV, 180 reference mAs), four low kV SE protocols (70more » and 80 kV using both SS and DS), and one DE protocol at 80/140 kV. Potential CM reduction with unchanged CNRs relative to the 120 kV protocol was calculated along with the corresponding increase in radiation dose. Results: The potential contrast media reductions were determined to be approximately 53% for DS 70 kV, 51% for SS 70 kV, 44% for DS 80 kV, 40% for SS 80 kV, and 20% for DE (all differences were significant, P < 0.05). Constant CNR could be achieved by using DS 70 kV for small to medium phantom sizes (16–26 kg/m{sup 2}) and for all sizes (16–35 kg/m{sup 2}) when using DS 80 kV and DE. Corresponding radiation doses increased by 60%–107%, 23%–83%, and 6%–12%, respectively. Conclusions: DS single energy CT can be used to reduce CM dose by 44%–53% with maintained CNR in adult abdominal examinations at the cost of an increased radiation dose. DS dual-energy CT allows reduction of CM dose by 20% at similar radiation dose as compared to a standard 120 kV single source.« less

Individual, social and physical environmental correlates of sedentary behaviours in adults: a systematic review protocol.

PubMed

Prince, Stephanie A; Gresty, Katelin M; Reed, Jennifer L; Wright, Erica; Tremblay, Mark S; Reid, Robert D

2014-10-21

Adults spend the majority of their time being sedentary, and evidence suggests that those who spend more of their day engaged in sedentary activities (TV viewing, sitting, screen-based activities) are at increased risk for morbidity and mortality, regardless of whether they exercise regularly. In order to develop effective interventions to reduce sedentary time, it is necessary to identify and understand the strongest modifiable factors of these behaviours. Therefore, the objective of this systematic review is to examine the available evidence in order to identify individual, social, environmental and policy correlates and determinants of sedentary behaviours (TV time, sitting time, screen time) and total sedentary time among adults. Six electronic databases will be searched to identify all studies that report on individual, social and/or environmental correlates and determinants of sedentary behaviours and total sedentary time in adults. Grey literature sources including theses, published conference abstracts and websites from relevant organizations will also be included. Articles that report on modifiable individual (e.g. health behaviours and status, self-efficacy, socio-economic status), social (e.g. crime, safety, social support, climate and capital), environmental (e.g. weather, workplace, home, neighbourhood, recreation environment, transportation environment) and policy correlates and determinants (based on study design) of sedentary behaviours in an adult population (mean age ≥18 years) will be included. Study quality and risk of bias will be assessed within and across all included studies. Harvest plots will be used to synthesize results across all correlates, and meta-analyses will be conducted where possible among studies with sufficient homogeneity. This review will provide a comprehensive examination of evidence in the field and will serve to highlight gaps for future research on the determinants of sedentary behaviours and inform intervention

Extraction Protocols for Individual Zebrafish's Ventricle Myosin and Skeletal Muscle Actin for In vitro Motility Assays

PubMed Central

Scheid, Lisa-Mareike; Weber, Cornelia; Bopp, Nasrin; Mosqueira, Matias; Fink, Rainer H. A.

2017-01-01

The in vitro motility assay (IVMA) is a technique that enables the measurement of the interaction between actin and myosin providing a relatively simple model to understand the mechanical muscle function. For actin-myosin IVMA, myosin is immobilized in a measurement chamber, where it converts chemical energy provided by ATP hydrolysis into mechanical energy. The result is the movement of fluorescently labeled actin filaments that can be recorded microscopically and analyzed quantitatively. Resulting sliding speeds and patterns help to characterize the underlying actin-myosin interaction that can be affected by different factors such as mutations or active compounds. Additionally, modulatory actions of the regulatory proteins tropomyosin and troponin in the presence of calcium on actin-myosin interaction can be studied with the IVMA. Zebrafish is considered a suitable model organism for cardiovascular and skeletal muscle research. In this context, straightforward protocols for the isolation and use of zebrafish muscle proteins in the IVMA would provide a useful tool in molecular studies. Currently, there are no protocols available for the mentioned purpose. Therefore, we developed fast and easy protocols for characterization of zebrafish proteins in the IVMA. Our protocols enable the interested researcher to (i) isolate actin from zebrafish skeletal muscle and (ii) extract functionally intact myosin from cardiac and skeletal muscle of individual adult zebrafish. Zebrafish tail muscle actin is isolated after acetone powder preparation, polymerized, and labeled with Rhodamine-Phalloidin. Myosin from ventricles of adult zebrafish is extracted directly into IVMA flow-cells. The same extraction protocol is applicable for comparably small tissue pieces as from zebrafish tail, mouse and frog muscle. After addition of the fluorescently labeled F-actin from zebrafish—or other origin—and ATP, sliding movement can be visualized using a fluorescence microscope and an

Development of a bedside viable ultrasound protocol to quantify appendicular lean tissue mass.

PubMed

Paris, Michael T; Lafleur, Benoit; Dubin, Joel A; Mourtzakis, Marina

2017-10-01

Ultrasound is a non-invasive and readily available tool that can be prospectively applied at the bedside to assess muscle mass in clinical settings. The four-site protocol, which images two anatomical sites on each quadriceps, may be a viable bedside method, but its ability to predict musculature has not been compared against whole-body reference methods. Our primary objectives were to (i) compare the four-site protocol's ability to predict appendicular lean tissue mass from dual-energy X-ray absorptiometry; (ii) optimize the predictability of the four-site protocol with additional anatomical muscle thicknesses and easily obtained covariates; and (iii) assess the ability of the optimized protocol to identify individuals with low lean tissue mass. This observational cross-sectional study recruited 96 university and community dwelling adults. Participants underwent ultrasound scans for assessment of muscle thickness and whole-body dual-energy X-ray absorptiometry scans for assessment of appendicular lean tissue. Ultrasound protocols included (i) the nine-site protocol, which images nine anterior and posterior muscle groups in supine and prone positions, and (ii) the four-site protocol, which images two anterior sites on each quadriceps muscle group in a supine position. The four-site protocol was strongly associated (R 2  = 0.72) with appendicular lean tissue mass, but Bland-Altman analysis displayed wide limits of agreement (-5.67, 5.67 kg). Incorporating the anterior upper arm muscle thickness, and covariates age and sex, alongside the four-site protocol, improved the association (R 2  = 0.91) with appendicular lean tissue and displayed narrower limits of agreement (-3.18, 3.18 kg). The optimized protocol demonstrated a strong ability to identify low lean tissue mass (area under the curve = 0.89). The four-site protocol can be improved with the addition of the anterior upper arm muscle thickness, sex, and age when predicting appendicular lean tissue mass

Protocol for rapid sequence intubation in pediatric patients -- a four-year study.

PubMed

Marvez-Valls, Eduardo; Houry, Debra; Ernst, Amy A; Weiss, Steven J; Killeen, James

2002-04-01

To evaluate a protocol for rapid sequence intubation (RSI) for pediatric patients in a Level 1 trauma center. Retrospective review of prospectively gathered Continuing Quality Improvement (CQI) data at an inner city Level 1 trauma center with an emergency medicine residency program. Protocols for RSI were established prior to initiating the study. All pediatric intubations at the center from February 1996 to February 2000 were included. Statistical analysis included descriptive statistics for categorical data and Chi-square for comparisons between groups. Over the 4-year study period there were 83 pediatric intubations ranging in age from 18 months to 17 years; mean age 8.6. All had data collected at the time of intubation. There were 20 (24%) females and 62 (76%) males (p<0.001). Reasons for intubation were related to trauma in 71 (86%) and medical reasons in 12 (14%) (p<0.001). Of the trauma intubations 7 (10%) were for gunshot wounds, 39 (55%) were secondary to MVCs, and the remainder (25; 35%) were from assaults, falls, and closed head injuries. The non-trauma intubations were for smoke inhalation, overdose, seizure, HIV related complications, eclampsia, and near drowning. Intubations were successful with one attempt in 65 (78%) cases. No surgical airways were necessary. Rocuronium was used in 4 cases. Protocol deviations did not lead to complications. This protocol based pediatric rapid sequence intubation method worked well in an EM residency program. More intubations were in males and more were necessary due to trauma in this group.

Comparison of the ultrashort gonadotropin-releasing hormone agonist-antagonist protocol with microdose flare -up protocol in poor responders: a preliminary study

PubMed Central

Berker, Bülent; Duvan, Candan İltemir; Kaya, Cemil; Aytaç, Ruşen; Şatıroğlu, Hakan

2010-01-01

Objective To determine the potential effect of the ultrashort gonadotropin-releasing hormone (GnRH) agonist/GnRH antagonist protocol versus the microdose GnRH agonist protocol in poor responders undergoing intracytoplasmic sperm injection (ICSI). Material and Methods The patients in the Agonist-Antagonist Group (n=41) were administered the ultrashort GnRH-agonist/ antagonist protocol, while the patients in the Microdose Group (n=41) were stimulated according to the microdose flare-up protocol. The mean number of mature oocytes retrieved was the primary outcome measure. Fertilization rate, implantation rate per embryo and clinical pregnancy rates were secondary outcome measures. Results There was no differenc between the mean number of mature oocytes retrieved in the two groups. There were also no statistical differences between the two groups in terms of peak serum E2 level, canceled cycles, endometrial thickness on hCG day, number of 2 pronucleus and number of embryos transferred. However, the total gonadotropin consumption and duration of stimulation were significantly higher with the Agonist-Antagonist Group compared with the Microdose Group. The implantation and clinical pregnancy rates were similar between the two groups. Conclusion Despite the high dose of gonadotropin consumption and longer duration of stimulation with the ultrashort GnRH agonist/ antagonist protocol, it seems that the Agonist-Antagonist Protocol is not inferior to the microdose protocol in poor responders undergoing ICSI. PMID:24591934

Comparison of the ultrashort gonadotropin-releasing hormone agonist-antagonist protocol with microdose flare -up protocol in poor responders: a preliminary study.

PubMed

Berker, Bülent; Duvan, Candan İltemir; Kaya, Cemil; Aytaç, Ruşen; Satıroğlu, Hakan

2010-01-01

To determine the potential effect of the ultrashort gonadotropin-releasing hormone (GnRH) agonist/GnRH antagonist protocol versus the microdose GnRH agonist protocol in poor responders undergoing intracytoplasmic sperm injection (ICSI). The patients in the Agonist-Antagonist Group (n=41) were administered the ultrashort GnRH-agonist/ antagonist protocol, while the patients in the Microdose Group (n=41) were stimulated according to the microdose flare-up protocol. The mean number of mature oocytes retrieved was the primary outcome measure. Fertilization rate, implantation rate per embryo and clinical pregnancy rates were secondary outcome measures. There was no differenc between the mean number of mature oocytes retrieved in the two groups. There were also no statistical differences between the two groups in terms of peak serum E2 level, canceled cycles, endometrial thickness on hCG day, number of 2 pronucleus and number of embryos transferred. However, the total gonadotropin consumption and duration of stimulation were significantly higher with the Agonist-Antagonist Group compared with the Microdose Group. The implantation and clinical pregnancy rates were similar between the two groups. Despite the high dose of gonadotropin consumption and longer duration of stimulation with the ultrashort GnRH agonist/ antagonist protocol, it seems that the Agonist-Antagonist Protocol is not inferior to the microdose protocol in poor responders undergoing ICSI.

Measurement properties of adult quality-of-life measurement instruments for eczema: protocol for a systematic review.

PubMed

Apfelbacher, Christian J; Heinl, Daniel; Prinsen, Cecilia A C; Deckert, Stefanie; Chalmers, Joanne; Ofenloch, Robert; Humphreys, Rosemary; Sach, Tracey; Chamlin, Sarah; Schmitt, Jochen

2015-04-16

Eczema is a common chronic or chronically relapsing skin disease that has a substantial impact on quality of life (QoL). By means of a consensus-based process, the Harmonising Outcome Measures in Eczema (HOME) initiative has identified QoL as one of the four core outcome domains to be assessed in all eczema trials (Allergy 67(9):1111-7, 2012). Various measurement instruments exist to measure QoL in adults with eczema, but there is a great variability in both content and quality (for example, reliability and validity) of the instruments used, and it is not always clear if the best instrument is being used. Therefore, the aim of the proposed research is a comprehensive systematic assessment of the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in adults with eczema. This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for adults with eczema. Medline via PubMed and EMBASE will be searched using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for adult patients with eczema. Eligibility assessment and data abstraction will be performed independently by two reviewers. Evidence tables will be generated for study characteristics, instrument characteristics, measurement properties, and interpretability. The quality of the measurement properties will be assessed using predefined criteria. Methodological quality of studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best evidence synthesis will be undertaken if more than one study has investigated a particular measurement property. The proposed systematic review will produce a comprehensive assessment of measurement properties of existing QoL instruments in

Brazilian version of the Protocole Montréal d'Evaluation de la Communication (Protocole MEC): normative and reliability data.

PubMed

Fonseca, Rochele Paz; Joanette, Yves; Côté, Hélène; Ska, Bernadette; Giroux, Francine; Fachel, Jandyra Maria Guimarães; Damasceno Ferreira, Gabriela; Parente, Maria Alice de Mattos Pimenta

2008-11-01

The lack of standardized instruments to evaluate communication disorders related to the right hemisphere was verified. A new evaluation tool was developed: Protocole Montréal d'Evaluation de la Communication--Protocole MEC, adapted to Brazilian Portuguese--Bateria Montreal de Avaliação da Comunicação--Bateria MAC (Montreal Evaluation of Communication Battery). The purpose was to present stratified normative data by age and educational level, and to verify the reliability parameters of the MEC Battery. 300 individuals, between the ages of 19 and 75 years, and levels of formal education between 2 and 35 years, participated in this study. They were divided equally into six normative groups, according to three age categories (young adults, intermediary age, and seniors) and two educational levels (low and high). Two procedures were used to check reliability: Cronbach alpha and reliability between evaluators, Results were established at the 10th percentile, and an alert point per task for each normative group. Cronbach's alpha was, in general, between .70 and .90 and the average rate of agreement between evaluators varied from .62 to .94. Standards of age and education were established. The reliability of this instrument was verified. The psychometric legitimization of the MEC Battery will contribute to the diagnostic process for communicative disorders.

Effect of Baduanjin exercise on cognitive function in older adults with mild cognitive impairment: study protocol for a randomised controlled trial.

PubMed

Zheng, Guohua; Huang, Maomao; Li, Shuzhen; Li, Moyi; Xia, Rui; Zhou, Wenji; Tao, Jing; Chen, Lidian

2016-04-11

Mild cognitive impairment (MCI) is an intermediate stage between the cognitive changes of normal aging and dementia characterised by a reduction in memory and/or other cognitive processes. An increasing number of studies have indicated that regular physical activity/exercise may have beneficial association with cognitive function of older adults with or without cognitive impairment. As a traditional Chinese Qigong exercise, Baduanjin may be even more beneficial in promoting cognitive ability in older adults with MCI, but the evidence is still insufficient. The main purpose of this study is to investigate the effect of Baduanjin exercise on neuropsychological outcomes of community-dwelling older adults with MCI, and to explore its mechanism of action from neuroimaging based on functional MRI (fMRI) and cerebrovascular function. The design of this study is a randomised, controlled trial with three parallel groups in a 1:1:1 allocation ratio with allocation concealment and assessor blinding. A total of 135 participants will be enrolled and randomised to the 24-week Baduanjin exercise intervention, 24-week brisk walking intervention and 24-week usual physical activity control group. Global cognitive function and the specific domains of cognition (memory, processing speed, executive function, attention and verbal learning and memory) will be assessed at baseline and 9, 17, 25 and 37 weeks after randomisation, while the structure and function of brain regions related to cognitive function and haemodynamic variables of the brain will be measured by fMRI and transcranial Doppler, respectively, at baseline and 25 and 37 weeks after randomisation. Ethics approval was given by the Medical Ethics Committee of the Second People's Hospital of Fujian Province (approval number 2014-KL045-02). The findings will be disseminated through peer-reviewed publications and at scientific conferences. ChiCTR-ICR-15005795; Pre-results. Published by the BMJ Publishing Group Limited. For

Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

PubMed

Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

2014-12-01

Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values.

PubMed

Ozarda, Yesim; Ichihara, Kiyoshi; Barth, Julian H; Klee, George

2013-05-01

The reference intervals (RIs) given in laboratory reports have an important role in aiding clinicians in interpreting test results in reference to values of healthy populations. In this report, we present a proposed protocol and standard operating procedures (SOPs) for common use in conducting multicenter RI studies on a national or international scale. The protocols and consensus on their contents were refined through discussions in recent C-RIDL meetings. The protocol describes in detail (1) the scheme and organization of the study, (2) the target population, inclusion/exclusion criteria, ethnicity, and sample size, (3) health status questionnaire, (4) target analytes, (5) blood collection, (6) sample processing and storage, (7) assays, (8) cross-check testing, (9) ethics, (10) data analyses, and (11) reporting of results. In addition, the protocol proposes the common measurement of a panel of sera when no standard materials exist for harmonization of test results. It also describes the requirements of the central laboratory, including the method of cross-check testing between the central laboratory of each country and local laboratories. This protocol and the SOPs remain largely exploratory and may require a reevaluation from the practical point of view after their implementation in the ongoing worldwide study. The paper is mainly intended to be a basis for discussion in the scientific community.

Comparison between stress myocardial perfusion SPECT recorded with cadmium-zinc-telluride and Anger cameras in various study protocols.

PubMed

Verger, Antoine; Djaballah, Wassila; Fourquet, Nicolas; Rouzet, François; Koehl, Grégoire; Imbert, Laetitia; Poussier, Sylvain; Fay, Renaud; Roch, Véronique; Le Guludec, Dominique; Karcher, Gilles; Marie, Pierre-Yves

2013-02-01

The results of stress myocardial perfusion SPECT could be enhanced by new cadmium-zinc-telluride (CZT) cameras, although differences compared to the results with conventional Anger cameras remain poorly known for most study protocols. This study was aimed at comparing the results of CZT and Anger SPECT according to various study protocols while taking into account the influence of obesity. The study population, which was from three different institutions equipped with identical CZT cameras, comprised 276 patients referred for study using protocols involving (201)Tl (n = 120) or (99m)Tc-sestamibi injected at low dose at stress ((99m)Tc-Low; stress/rest 1-day protocol; n = 110) or at high dose at stress ((99m)Tc-High; rest/stress 1-day or 2-day protocol; n = 46). Each Anger SPECT scan was followed by a high-speed CZT SPECT scan (2 to 4 min). Agreement rates between CZT and Anger SPECT were good irrespective of the study protocol (for abnormal SPECT, (201)Tl 92 %, (99m)Tc-Low 86 %, (99m)Tc-High 98 %), although quality scores were much higher for CZT SPECT with all study protocols. Overall correlations were high for the extent of myocardial infarction (r = 0.80) and a little lower for ischaemic areas (r = 0.72), the latter being larger on Anger SPECT (p < 0.001). This larger extent was mainly observed in 50 obese patients who were in the (201)Tl or (99m)Tc-Low group and in whom stress myocardial counts were particularly low with Anger SPECT (228 ± 101 kcounts) and dramatically enhanced with CZT SPECT (+279 ± 251 %). Concordance between the results of CZT and Anger SPECT is good regardless of study protocol and especially when excluding obese patients who have low-count Anger SPECT and for whom myocardial counts are dramatically enhanced on CZT SPECT.

Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.

PubMed

Matthews, Lynsay; Pugmire, Juliana; Moore, Laurence; Kelson, Mark; McConnachie, Alex; McIntosh, Emma; Morgan-Trimmer, Sarah; Murphy, Simon; Hughes, Kathryn; Coulman, Elinor; Utkina-Macaskill, Olga; Simpson, Sharon Anne

2017-10-25

HelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite 'helpers' from their social circle to help them achieve their goal(s). To test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals. 12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI) > 30 kg/m 2 and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual

Safety of a no-fast protocol for tracheotomy in critical care

PubMed Central

Hartl, Trevor; Anderson, Donald; Levi, Jasna

2015-01-01

Summary With modern anesthesia, aspiration is an exceedingly rare complication, and we have learned that a prolonged fast can result in serious adverse effects in critically ill patients. We discuss the no-fast protocol implemented at Vancouver General Hospital in 2007 for intubated, tube-fed adult patients who underwent elective open tracheotomy. PMID:25621914

Adult Adjustment of Survivors of Institutional Child Abuse in Ireland

ERIC Educational Resources Information Center

Carr, Alan; Dooley, Barbara; Fitzpatrick, Mark; Flanagan, Edel; Flanagan-Howard, Roisin; Tierney, Kevin; White, Megan; Daly, Margaret; Egan, Jonathan

2010-01-01

Objective: To document the adult adjustment of survivors of childhood institutional abuse. Method: Two hundred and forty-seven adult survivors of institutional abuse with a mean age of 60 were interviewed with a protocol that included the Childhood Trauma Questionnaire, modules from the Structured Clinical Interview for Axis I Disorders of DSM IV…

Optimizing the Protocol for Pulmonary Cryoablation: A Comparison of a Dual- and Triple-Freeze Protocol

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hinshaw, J. Louis, E-mail: jhinshaw@uwhealth.or; Littrup, Peter J.; Durick, Nathan

2010-12-15

The purpose of this study was to compare a double freeze-thaw protocol to a triple freeze-thaw protocol for pulmonary cryoablation utilizing an in vivo porcine lung model. A total of 18 cryoablations were performed in normal porcine lung utilizing percutaneous technique with 9 each in a double- (10-5-10) and triple-freeze (3-3-7-7-5) protocol. Serial noncontrast CT images were obtained during the ablation. CT imaging findings and pathology were reviewed. No imaging changes were identified during the initial freeze cycle with either protocol. However, during the first thaw cycle, a region of ground glass opacity developed around the probe with both protocols.more » Because the initial freeze was shorter with the triple freeze-thaw protocol, the imaging findings were apparent sooner with this protocol (6 vs. 13 min). Also, despite a shorter total freeze time (15 vs. 20 min), the ablation zone identified with the triple freeze-thaw protocol was not significantly different from the double freeze-thaw protocol (mean diameter: 1.67 {+-} 0.41 cm vs. 1.66 {+-} 0.21 cm, P = 0.77; area: 2.1 {+-} 0.48 cm{sup 2} vs. 1.99 {+-} 0.62 cm{sup 2}, P = 0.7; and circularity: 0.95 {+-} 0.04 vs. 0.96 {+-} 0.03, P = 0.62, respectively). This study suggests that there may be several advantages of a triple freeze-thaw protocol for pulmonary cryoablation, including earlier identification of the imaging findings associated with the ablation, the promise of a shorter procedure time or larger zones of ablation, and theoretically, more effective cytotoxicity related to the additional freeze-thaw cycle.« less

Exploring the feasibility and acceptability of a recovery-focused group therapy intervention for adults with bipolar disorder: trial protocol.

PubMed

Beck, Alison K; Baker, Amanda; Jones, Steven; Lobban, Fiona; Kay-Lambkin, Frances; Attia, John; Banfield, Michelle

2018-01-31

Improving accessible, acceptable recovery-oriented service provision for people with bipolar disorder (BD) is an important priority. Mindfulness and acceptance-based cognitive and behavioural therapies (or 'third -wave' CBT) may prove fruitful due to the considerable overlap between these approaches and key features of personal recovery. Groups also confer therapeutic benefits consistent with personal recovery and may improve recovery-oriented service provision by adding another modality for accessing support. The primary objective of this trial is to explore the feasibility and acceptability of a new recovery-focused group therapy (RfGT) intervention for adults with BD. This is the first published feasibility assessment of a time-limited RfGTrecovery-focused group therapy intervention for BD. This protocol describes an open feasibility study, utilising a pre-treatment design versus post- treatment design and nested qualitative evaluation. Participants will be recruited from the Central Coast region of New South Wales, Australia, from primary care providers, specialist mental health services, non-government organisations and via self-referral. The primary outcomes are feasibility and acceptability as indexed by recruitment, retention, intervention adherence, adverse events (if any) and detailed consumer feedback. Clinical outcomes and process measures will be assessed to inform future research. Primary outcome data will utiliseuse descriptive statistics (eg, summarizingsummarising recruitment, demographics, attendance, attrition and intervention adherence). Secondary outcomes will be assessed using repeated-measures analysis of covariance across all time points (including change, effect size and variability). Ethical approval has been granted by the Northern Sydney Local Health District HREChuman research ethics committee (HREC) (HREC/16/HAWKE/69) and The University of Newcastle HREC (H-2016-0107). The Ffindings will be used to improve the intervention per user

Transcranial Doppler and Lower Extremity Function in Older Adults: Einstein Aging Study.

PubMed

Ezzati, Ali; Rundek, Tatjana; Verghese, Joe; Derby, Carol A

2017-12-01

To determine whether transcranial Doppler ultrasound (TCD) measures of mean blood flow velocity (MBFV) in the major cerebral arteries are associated with measures of lower extremity function in community-dwelling older adults. Cross-sectional study. Community sample. Individuals aged 70 and older (mean 79.5, 54% female) without dementia participating in the Einstein Aging Study (N = 200). All participants underwent TCD assessments and tests of lower extremity function at an annual clinic visit. Average MBFV for anterior (left and right anterior and middle cerebral arteries (MCAs)) and posterior (vertebral (VA) and basilar (BA) artery) circulation was measured using a standardized TCD protocol. Lower extremity function was characterized according to gait speed (cm/s) measured using an instrumented walkway, balance according to unipedal stance time (UPST, seconds), and lower extremity strength according to timed repeated chair rise (seconds). Multiple regression models adjusted for age, sex, race, education, and medical comorbidities showed that lower MBFV in the MCA was associated with slower gait speed and chair rise time but not with UPST. Ordinal regression models showed that lower MBFV in the VA and BA is associated with shorter UPST. Low MBFV in the anterior and posterior cerebral circulation was associated with worse lower extremity function and balance in older adults. This might be indicative of the importance of age-related changes in cerebral hemodynamics in the function of brain regions involved in specific aspects of physical performance. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Effectiveness of oxaliplatin desensitization protocols.

PubMed

Cortijo-Cascajares, Susana; Nacle-López, Inmaculada; García-Escobar, Ignacio; Aguilella-Vizcaíno, María José; Herreros-de-Tejada, Alberto; Cortés-Funes Castro, Hernán; Calleja-Hernández, Miguel-Ángel

2013-03-01

Hypersensitivity reaction (HSR) to antineoplastic drugs can force doctors to stop treatment and seek other alternatives. These alternatives may be less effective, not as well tolerated and/or more expensive. Another option is to use desensitization protocols that induce a temporary state of tolerance by gradually administering small quantities of the antineoplastic drug until the therapeutic dosage is reached. The aim of this study is to assess the effectiveness of oxaliplatin desensitization protocols. A retrospective observational study was carried out between January 2006 and May 2011. The inclusion criteria were patients undergoing chemotherapy treatment with oxaliplatin who had developed an HSR to the drug and who were candidates for continuing the treatment using a desensitization protocol. The patients' clinical records were reviewed and variables were gathered relating to the patient, the treatment, the HSR, and the desensitization protocol administered. The data were analysed using version 18.0 of the statistics program SPSS. A total of 53 desensitization protocols were administered to 21 patients. In 89 % of these cases, no new reactions occurred while the drug was being administered. New reactions of mild severity only occurred in 11 % of cases, and none of these reactions were severe enough for treatment to be stopped. All patients were able to complete the desensitization protocol. This study confirms that oxaliplatin desensitization protocols are safe and effective and allow patients to continue with the treatment that initially caused an HSR.

Successful induction of oestrus, ovulation and pregnancy in adult ewes and ewe lambs out of the breeding season using a GnRH+progesterone oestrus synchronisation protocol.

PubMed

Martinez, M F; McLeod, B; Tattersfield, G; Smaill, B; Quirke, L D; Juengel, J L

2015-04-01

A series of experiments was designed to assess the effect of a treatment protocol (U-synch) for inducing oestrus and ovulation out of the breeding season in adult ewes and ewe lambs. The protocol consisted of a 7-day treatment with an intravaginal progesterone-releasing device (IPRD), administration of GnRH at IPRD insertion on Day 0, and equine chorionic gonadotropin (eCG) and prostaglandin F2α at IPRD removal on Day 7. In Experiment 1, 50 or 100 μg GnRH were sufficient to induce ovulation at the beginning of the protocol in 3/9 and 4/9 ewes, respectively; while the resulting proportion of sheep ovulating after the treatment protocol was 88.9% and 77.8% in ewes initially treated with 50 or 100 μg GnRH, respectively. In Experiment 2, the proportion of Romney-cross ewe lambs ovulating was greater (P<0.0001) in the U-synch group (95.4%) than in the untreated Control group (3.2%). In Experiment 3, pregnancy rates of Dorset-cross sheep in the U-synch (60.7%) and Standard (12-day IPRD and eCG treatment; 56.5%) groups were greater (P=0.01) than in the untreated Control group (43.4%). The incidence of twin pregnancies was greater (P=0.005) in the U-synch group than in the Control group. A 7-day IPRD treatment including GnRH treatment at device insertion and eCG treatment at device removal induced oestrus and ovulation during the non-breeding season in a high proportion of mature ewes and ewe lambs. High pregnancy rates to natural mating, with a low rate of triplet pregnancies, were also observed. Copyright © 2015 Elsevier B.V. All rights reserved.

Levels and trends of child and adult mortality rates in the Islamic Republic of Iran, 1990-2013; protocol of the NASBOD study.

PubMed

Mohammadi, Younes; Parsaeian, Mahboubeh; Farzadfar, Farshad; Kasaeian, Amir; Mehdipour, Parinaz; Sheidaei, Ali; Mansouri, Anita; Saeedi Moghaddam, Sahar; Djalalinia, Shirin; Mahmoudi, Mahmood; Khosravi, Ardeshir; Yazdani, Kamran

2014-03-01

Calculation of burden of diseases and risk factors is crucial to set priorities in the health care systems. Nevertheless, the reliable measurement of mortality rates is the main barrier to reach this goal. Unfortunately, in many developing countries the vital registration system (VRS) is either defective or does not exist at all. Consequently, alternative methods have been developed to measure mortality. This study is a subcomponent of NASBOD project, which is currently conducting in Iran. In this study, we aim to calculate incompleteness of the Death Registration System (DRS) and then to estimate levels and trends of child and adult mortality using reliable methods. In order to estimate mortality rates, first, we identify all possible data sources. Then, we calculate incompleteness of child and adult morality separately. For incompleteness of child mortality, we analyze summary birth history data using maternal age cohort and maternal age period methods. Then, we combine these two methods using LOESS regression. However, these estimates are not plausible for some provinces. We use additional information of covariates such as wealth index and years of schooling to make predictions for these provinces using spatio-temporal model. We generate yearly estimates of mortality using Gaussian process regression that covers both sampling and non-sampling errors within uncertainty intervals. By comparing the resulted estimates with mortality rates from DRS, we calculate child mortality incompleteness. For incompleteness of adult mortality, Generalized Growth Balance, Synthetic Extinct Generation and a hybrid of two mentioned methods are used. Afterwards, we combine incompleteness of three methods using GPR, and apply it to correct and adjust the number of deaths. In this study, we develop a conceptual framework to overcome the existing challenges for accurate measuring of mortality rates. The resulting estimates can be used to inform policy-makers about past, current and

Effective strategies for prevention, control, and treatment of obesity in primary health care setting for adolescents, adults, and elderly people: A protocol for systematic review and meta-analysis.

PubMed

Marques, Emanuele Souza; Leite, Tatiana Henriques; Azeredo, Catarina Machado; Cunha, Diana Barbosa; Verly Júnior, Eliseu

2018-06-01

It is unquestionable that obesity is a global epidemic and one of the main public health problems in the world. The management of obesity in Primary Health Care has an important role if being considered the magnitude and serious consequence of this problem. Despite this, there is no effective standard protocol for the treatment of this disease. Studies that synthesize and assess the effectiveness of strategies for prevention, control, and treatment of obesity in Primary Health Care setting are still scarce. The objective of this study is review and synthesize study evidence for obesity management strategies among adolescents, adults and elderly developed at the Primary Health Care worldwide. Seven electronic databases (Medline, Lilacs, Embase, Psycinfo, Cochrane, WHOLIS and Open Gray) will be searched with no date limit for identification of clinical trials examining the effectiveness of prevention, control and treatment of obesity in Primary Health Care. As primary outcome will be changes in body weight. As secondary outcomes will be body mass index, body adiposity, waist circumference, and waist-hip ratio. Two independent authors will perform the selection of studies, data extraction, and the assessment of risk of bias. The results will be published in a peer-reviewed journal. This systematic review will be first to synthesize scientific evidence for obesity management strategies at Primary Health Care among adolescents, adults, and elderly. The review will benefit healthcare professionals and policymakers. Ethical approval is not required in this study because the data used include peer-reviewed publications, which do not comprise any information that could identify subjects. PROSPERO (CRD42018092416).

Stimulation of the ovaries in women with breast cancer undergoing fertility preservation: Alternative versus standard stimulation protocols; the study protocol of the STIM-trial.

PubMed

Dahhan, T; Balkenende, E M E; Beerendonk, C C M; Fleischer, K; Stoop, D; Bos, A M E; Lambalk, C B; Schats, R; van Golde, R J T; Schipper, I; Louwé, L A; Cantineau, A E P; Smeenk, J M J; de Bruin, J P; Reddy, N; Kopeika, Y; van der Veen, F; van Wely, M; Linn, S C; Goddijn, M

2017-10-01

Chemotherapy for breast cancer may have a negative impact on reproductive function due to gonadotoxicity. Fertility preservation via banking of oocytes or embryos after ovarian stimulation with FSH can increase the likelihood of a future live birth. It has been hypothesized that elevated serum estrogen levels during ovarian stimulation may induce breast tumour growth. This has led to the use of alternative stimulation protocols with addition of tamoxifen or letrozole. The effectiveness of these stimulation protocols in terms of oocyte yield is unknown. Randomized open-label trial comparing ovarian stimulation plus tamoxifen and ovarian stimulation plus letrozole with standard ovarian stimulation in the course of fertility preservation. The study population consists of women with breast cancer who opt for banking of oocytes or embryos, aged 18-43years at randomisation. Primary outcome is the number of oocytes retrieved at follicle aspiration. Secondary outcomes are number of mature oocytes retrieved, number of oocytes or embryos banked and peak E2 levels during ovarian stimulation. Concerning the lack of evidence on which stimulation protocol should be used in women with breast cancer and the growing demand for fertility preservation, there is an urgent need to undertake this study. By performing this study, we will be able to closely monitor the effects of various stimulation protocols in women with breast cancer and pave the way for long term follow up on the safety of this procedure in terms of breast cancer prognosis. NTR4108. Copyright © 2017 Elsevier Inc. All rights reserved.

Analyzing Unstructured Communication in a Computer-Mediated Environment for Adults With Type 2 Diabetes: A Research Protocol.

PubMed

Lewinski, Allison A; Anderson, Ruth A; Vorderstrasse, Allison A; Fisher, Edwin B; Pan, Wei; Johnson, Constance M

2017-04-24

Individuals with type 2 diabetes have an increased risk for comorbidities such as heart disease, lower limb amputations, stroke, and renal failure. Multiple factors influence development of complications in a person living with type 2 diabetes; however, an individual's self-management behaviors may delay the onset of, or lessen the severity of, these complications. Social support provides personal, informal advice and knowledge that helps individuals initiate and sustain self-management and adherence. Our aim was to gain an understanding of type 2 diabetes social interaction in a virtual environment, one type of computer-mediated environment (CME), and the social support characteristics that increase and sustain self-management in adults living with chronic illness. This study is a secondary analysis of longitudinal data collected in a CME study, Second Life Impacts Diabetes Education & Self-Management (1R21-LM010727-01). This virtual environment replicated a real-life community where 6 months of naturalistic synchronous voice conversations, emails, and text chats were recorded among participants and providers. This analysis uses a mixed-methods approach to explore and compare qualitative and quantitative findings. This analysis is guided by two theories: Strong/Weak Ties Theory and Social Penetration Theory. Qualitative data will be analyzed using content analysis, and we will complete descriptive statistics on the quantified variables (eg, average number of ties). Institutional review board approval was obtained in June 2016. This study is in progress. Interventions provided through virtual environments are a promising solution to increasing self-management practices. However, little is known of the depth, breadth, and quality of social support that is exchanged and how interaction supports self-management and relates to health outcomes. This study will provide knowledge that will help guide clinical practice and policy to enhance social support for chronic

Elder Abuse Identification in the Prehospital Setting: An Examination of State Emergency Medical Services Protocols.

PubMed

Namboodri, Brooke L; Rosen, Tony; Dayaa, Joseph A; Bischof, Jason J; Ramadan, Nadeem; Patel, Mehul D; Grover, Joseph; Brice, Jane H; Platts-Mills, Timothy F

2018-03-22

To describe statewide emergency medical service (EMS) protocols relating to identification, management, and reporting of elder abuse in the prehospital setting. Cross-sectional analysis. Statewide EMS protocols in the United States. Publicly available statewide EMS protocols identified from published literature, http://EMSprotocols.org, and each state's public health website. Protocols were reviewed to determine whether elder abuse was mentioned, elder abuse was defined, potential indicators of elder abuse were listed, management of older adults experiencing abuse was described, and instructions regarding reporting were provided. EMS protocols for child abuse were reviewed in the same manner for the purpose of comparison. Of the 35 publicly available statewide EMS protocols, only 14 (40.0%) mention elder abuse. Of protocols that mention elder abuse, 6 (42.9%) define elder abuse, 10 (71.4%) describe indicators of elder abuse, 8 (57.1%) provide instruction regarding management, and 12 (85.7%) provide instruction regarding reporting. Almost twice as many states met each of these metrics for child abuse. Statewide EMS protocols for elder abuse vary in regard to identification, management, and reporting, with the majority of states having no content on this subject. Expansion and standardization of protocols may increase the identification of elder abuse. © 2018, Copyright the Authors Journal compilation © 2018, The American Geriatrics Society.

The Functional Fitness MOT Test Battery for Older Adults: Protocol for a Mixed-Method Feasibility Study.

PubMed

de Jong, Lex D; Peters, Andy; Hooper, Julie; Chalmers, Nina; Henderson, Claire; Laventure, Robert Me; Skelton, Dawn A

2016-06-20

Increasing physical activity (PA) brings many health benefits, but engaging people in higher levels of PA after their 60s is not straightforward. The Functional Fitness MOT (FFMOT) is a new approach which aims to raise awareness about the importance of components of fitness (strength, balance, flexibility), highlight benefits of PA, engages older people in health behavior change discussions, and directs them to local activity resources. This battery of tests combined with a brief motivational interview has not been tested in terms of feasibility or effectiveness. To assess whether the FFMOT, provided in a health care setting, is appealing to older patients of a community physiotherapy service and to understand the views and perceptions of the older people undergoing the FFMOT regarding the intervention, as well as the views of the physiotherapy staff delivering the intervention. Secondary aims are to assess the feasibility of carrying out a phase 2 pilot randomized controlled trial of the FFMOT, in the context of a community physiotherapy service, by establishing whether enough patients can be recruited and retained in the study, and enough outcome data can be generated. A mixed-methods feasibility study will be conducted in two physiotherapy outpatient clinics in the United Kingdom. A total of 30 physically inactive, medically stable older adults over the age of 60 will be provided with an individual FFMOT, comprising a set of six standardized, validated, age-appropriate tests aimed at raising awareness of the different components of fitness. The results of these tests will be used to provide the participants with feedback on performance in comparison to sex and age-referenced norms. This will be followed by tailored advice on how to become more active and improve fitness, including advice on local opportunities to be more active. Subsequently, participants will be invited to attend a focus group to discuss barriers and motivators to being more active, health

An orthopedist's guide to shoulder ultrasound: a systematic review of examination protocols.

PubMed

Amoo-Achampong, Kelms; Nwachukwu, Benedict U; McCormick, Frank

2016-11-01

The utilization of musculoskeletal ultrasound has expanded within the setting of the orthopedic clinic as a cost-effective, point-of-care diagnostic tool for shoulder pathology. In experienced hands, ultrasound exhibits capabilities equivalent to that of magnetic resonance imaging in the diagnosis of many shoulder diseases including full-thickness and partial-thickness rotator cuff tears. Although similarly effective in identifying additional shoulder disease processes, major obstacles to its widespread use include user dependence and intrinsic limitation to extra-articular diagnosis. The purpose of this review is to present a step-by-step guide of how to perform a comprehensive shoulder examination and to discuss the appropriate use, economic benefit and implementation of ultrasound within the clinic. A systematic search (June 2016) of PubMed, Scopus, and EMBASE databases was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for literature presenting shoulder ultrasound examination protocols. Included studies were peer-reviewed articles or academic society endorsed protocols presenting comprehensive sonographic examinations of the adult shoulder. Papers with limited or single structure examination descriptions, non-English language, and publication dates before 1980 were excluded. Final papers meeting criteria were secondarily screened for publication after 2005 to reflect the current state of ultrasound imaging. The search yielded 1,725 unique articles with 17 studies meeting final selection criteria. Information from identified studies was summarized to formulate a 4-part shoulder examination protocol, including steps most pertinent to orthopedic in-office diagnoses. In agreement with previous studies, the inexperienced orthopedic surgeon can be quickly trained to expert level proficiency in shoulder ultrasound diagnosis. Using an established protocol, a comprehensive, yet effective shoulder

Study protocol for the ‘HelpMeDoIt!’ randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity

PubMed Central

Matthews, Lynsay; Pugmire, Juliana; Moore, Laurence; Kelson, Mark; McConnachie, Alex; McIntosh, Emma; Morgan-Trimmer, Sarah; Murphy, Simon; Hughes, Kathryn; Coulman, Elinor; Utkina-Macaskill, Olga; Simpson, Sharon Anne

2017-01-01

Introduction HelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite ‘helpers’ from their social circle to help them achieve their goal(s). Aim To test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals. Methods and analysis 12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)≥30 kg/m2 and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation

Making the Most of Mealtimes (M3): protocol of a multi-centre cross-sectional study of food intake and its determinants in older adults living in long term care homes.

PubMed

Keller, Heather H; Carrier, Natalie; Slaughter, Susan; Lengyel, Christina; Steele, Catriona M; Duizer, Lisa; Brown, K Steve; Chaudhury, Habib; Yoon, Minn N; Duncan, Alison M; Boscart, Veronique M; Heckman, George; Villalon, Lita

2017-01-13

Older adults living in long term care (LTC) homes are nutritionally vulnerable, often consuming insufficient energy, macro- and micronutrients to sustain their health and function. Multiple factors are proposed to influence food intake, yet our understanding of these diverse factors and their interactions are limited. The purpose of this paper is to fully describe the protocol used to examine determinants of food and fluid intake among older adults participating in the Making the Most of Mealtimes (M3) study. A conceptual framework that considers multi-level influences on mealtime experience, meal quality and meal access was used to design this multi-site cross-sectional study. Data were collected from 639 participants residing in 32 LTC homes in four Canadian provinces by trained researchers. Food intake was assessed with three-days of weighed food intake (main plate items), as well as estimations of side dishes, beverages and snacks and compared to the Dietary Reference Intake. Resident-level measures included: nutritional status, nutritional risk; disease conditions, medication, and diet prescriptions; oral health exam, signs of swallowing difficulty and olfactory ability; observed eating behaviours, type and number of staff assisting with eating; and food and foodservice satisfaction. Function, cognition, depression and pain were assessed using interRAI LTCF with selected items completed by researchers with care staff. Care staff completed a standardized person-directed care questionnaire. Researchers assessed dining rooms for physical and psychosocial aspects that could influence food intake. Management from each site completed a questionnaire that described the home, menu development, food production, out-sourcing of food, staffing levels, and staff training. Hierarchical regression models, accounting for clustering within province, home and dining room will be used to determine factors independently associated with energy and protein intake, as proxies for

The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial.

PubMed

White, David; Waugh, Norman; Elliott, Jackie; Lawton, Julia; Barnard, Katharine; Campbell, Michael J; Dixon, Simon; Heller, Simon

2014-09-03

People with type 1 diabetes (T1DM) require insulin therapy to sustain life, and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications. Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump (continuous subcutaneous insulin infusion), a more costly option with benefits for some patients. The UK National Institute for Health and Care Excellence (NICE) recommend the use of pumps for patients with the greatest need, citing insufficient evidence to approve extension to a wider population. Far fewer UK adults use pumps than in comparable countries. Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment. This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections, where both groups are provided with high-quality structured education. A multicentre, parallel group, cluster randomised controlled trial among 280 adults with T1DM. All participants attended the week-long dose adjustment for normal eating (DAFNE) structured education course, and receive either multiple daily injections or pump therapy for 2 years. The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis. The primary outcome will be the change in glycosylated haemoglobin (HbA1c) at 24 months in those participants whose baseline HbA1c is at or above 7.5% (58 mmol/mol). The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5% (58 mmol/mol) or less at 24 months. The protocol was approved by the Research Ethics Committee North West, Liverpool East and received Medicines and Healthcare products Regulatory Agency (MHRA) clinical trials authorisation. Each participating centre gave National Health Service R&D approval. We shall disseminate study findings to study

The impact of financial incentives on physical activity in adults: a systematic review protocol.

PubMed

Luong, My-Linh Nguyen; Bennell, Kim L; Hall, Michelle; Harris, Anthony; Hinman, Rana S

2018-01-25

Most adults fail to meet global physical activity guidelines set out by the World Health Organization. In recent years, behavioural economic principles have been used to design novel interventions that increase physical activity. Immediate financial rewards, for instance, can motivate an individual to change physical activity behaviour by lowering the opportunity costs of exercise. This systematic review will summarise the evidence about the effectiveness of financial incentive interventions for improving physical activity in adults. We will search MEDLINE, Embase, Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health Literature, Web of Science, Scopus, PsycINFO, EconLit, SPORTDiscus, the National Health Service Economic Evaluation Database, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform from inception using a comprehensive, electronic search strategy. The search strategy will include terms related to 'financial incentive' and 'physical activity'. Only randomised controlled trials that investigate the effect of financial incentives on physical activity in adult populations and that are written in the English language will be included. Two review authors will independently screen abstracts and titles, complete full text reviews and extract data on objective and self-reported physical activity outcomes. The authors will also assess the study quality using the Cochrane risk of bias tool and provide a systematic presentation and synthesis of the included studies' characteristics and results. If more than two studies are sufficiently similar in population, settings and interventions, we will pool the data to conduct a meta-analysis. If we are unable to perform a meta-analysis, we will conduct a narrative synthesis of the results and produce forest plots for individual studies. Our subgroup analyses will examine the differential effects of an intervention in healthy

Data Resource Profile: The World Health Organization Study on global AGEing and adult health (SAGE)

PubMed Central

Kowal, Paul; Chatterji, Somnath; Naidoo, Nirmala; Biritwum, Richard; Fan, Wu; Lopez Ridaura, Ruy; Maximova, Tamara; Arokiasamy, Perianayagam; Phaswana-Mafuya, Nancy; Williams, Sharon; Snodgrass, J Josh; Minicuci, Nadia; D'Este, Catherine; Peltzer, Karl; Boerma, J Ties; Yawson, A.; Mensah, G.; Yong, J.; Guo, Y.; Zheng, Y.; Parasuraman, P.; Lhungdim, H.; Sekher, TV.; Rosa, R.; Belov, VB.; Lushkina, NP; Peltzer, K.; Makiwane, M.; Zuma, K.; Ramlagan, S.; Davids, A.; Mbelle, N.; Matseke, G.; Schneider, M.; Tabane, C.; Tollman, S.; Kahn, K.; Ng, N.; Juvekar, S.; Sankoh, O.; Debpuur, CY.; Nguyen, TK Chuc; Gomez-Olive, FX.; Hakimi, M.; Hirve, S.; Abdullah, S.; Hodgson, A.; Kyobutungi, C.; Egondi, T.; Mayombana, C.; Minh, HV.; Mwanyangala, MA.; Razzaque, A.; Wilopo, S.; Streatfield, PK.; Byass, P.; Wall, S.; Scholten, F.; Mugisha, J.; Seeley, J.; Kinyanda, E.; Nyirenda, M.; Mutevedzi, P.; Newell, M-L.

2012-01-01

Population ageing is rapidly becoming a global issue and will have a major impact on health policies and programmes. The World Health Organization’s Study on global AGEing and adult health (SAGE) aims to address the gap in reliable data and scientific knowledge on ageing and health in low- and middle-income countries. SAGE is a longitudinal study with nationally representative samples of persons aged 50+ years in China, Ghana, India, Mexico, Russia and South Africa, with a smaller sample of adults aged 18–49 years in each country for comparisons. Instruments are compatible with other large high-income country longitudinal ageing studies. Wave 1 was conducted during 2007–2010 and included a total of 34 124 respondents aged 50+ and 8340 aged 18–49. In four countries, a subsample consisting of 8160 respondents participated in Wave 1 and the 2002/04 World Health Survey (referred to as SAGE Wave 0). Wave 2 data collection will start in 2012/13, following up all Wave 1 respondents. Wave 3 is planned for 2014/15. SAGE is committed to the public release of study instruments, protocols and meta- and micro-data: access is provided upon completion of a Users Agreement available through WHO’s SAGE website (www.who.int/healthinfo/systems/sage) and WHO’s archive using the National Data Archive application (http://apps.who.int/healthinfo/systems/surveydata). PMID:23283715

Translating Behavior Change Principles Into a Blended Exercise Intervention for Older Adults: Design Study.

PubMed

Mehra, Sumit; Visser, Bart; Dadema, Tessa; van den Helder, Jantine; Engelbert, Raoul Hh; Weijs, Peter Jm; Kröse, Ben Ja

2018-05-02

Physical activity can prevent or delay age-related impairments and prolong the ability of older adults to live independently. Community-based programs typically offer classes where older adults can exercise only once a week under the guidance of an instructor. The health benefits of such programs vary. Exercise frequency and the duration of the program play a key role in realizing effectiveness. An auxiliary home-based exercise program can provide older adults the opportunity to exercise more regularly over a prolonged period of time in the convenience of their own homes. Furthermore, mobile electronic devices can be used to motivate and remotely guide older adults to exercise in a safe manner. Such a blended intervention, where technology is combined with personal guidance, needs to incorporate behavior change principles to ensure effectiveness. The aim of this study was to identify theory-based components of a blended intervention that supports older adults to exercise at home. The Medical Research Council framework was used to develop the blended intervention. Insights from focus group, expert panels, and literature were combined into leading design considerations. A client-server system had been developed that combined a tablet app with a database in the cloud and a Web-based dashboard that can be used by a personal coach to remotely monitor and guide older adults. The app contains several components that facilitate behavior change-an interactive module for goal setting, the ability to draw up a personal training schedule from a library containing over 50 exercise videos, progress monitoring, and possibilities to receive remote feedback and guidance of a personal coach. An evidence-based blended intervention was designed to promote physical activity among older adults. The underlying design choices were underpinned by behavior change techniques that are rooted in self-regulation. Key components of the tablet-supported intervention were a tailored program that

The Benefits of Adult Piano Study as Self-Reported by Selected Adult Piano Students

ERIC Educational Resources Information Center

Jutras, Peter J.

2006-01-01

Adult piano students (N = 711) from 24 states across the U.S. rated the existence and importance of 31 potential benefits of adult piano study. Benefits selected from existing adult music and leisure-benefit research were organized into three categories: Personal, Skill, and Social/Cultural. The category of Skill Benefits was the most-agreed-upon…

Isolation and Characterization of Extracellular Vesicles from Adult Schistosoma japonicum.

PubMed

Liu, Juntao; Zhu, Lihui; Wang, Lihui; Chen, Yongjun; Giri, Bikash Ranjan; Li, Jianjun; Cheng, Guofeng

2018-05-22

Extracellular vesicles (EVs) are membranous vesicles released by a variety of cells into the extracellular microenvironment. EVs represent a population of heterogeneous vesicles, whose size range between 40 and 1,000 nm. Accumulated evidence indicated that EVs play important regulatory roles in pathogen-host interactions. A deep understanding of schistosome EVs should provide insights into the mechanisms underlying schistosome-host interactions, enabling development of novel strategies against schistosomiasis. Here, we aim to further study EVs functions in schistosomes by presenting a protocol for the isolation and characterization of EVs from adult Schistosoma japonicum (S. japonicum). EVs were isolated from in vitro culture medium using centrifugation combined with a commercial exosome isolation kit. The isolated S. japonicum EVs (SjEVs) typically possess a diameter of 100 - 400 nm, and are characterized by transmission electronic microscopy and western blotting. The usage of PKH67 dye-labeled SjEVs has demonstrated that SjEVs are internalized by the recipient cells. Overall, our protocol provides an alternative method for isolating EVs from adult schistosomes; the isolated SjEVs may be suitable for functional analysis.

A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

PubMed Central

2011-01-01

Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly) or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823 PMID:21255431

Assessing the Quality, Feasibility, and Efficacy of Electronic Patient Platforms Designed to Support Adolescents and Young Adults With Cancer: A Systematic Review Protocol

PubMed Central

McCann, Lisa

2017-01-01

Background A range of innovative websites, mobile technologies, eHealth and mHealth platforms have emerged to support adolescents and young adults (AYAs) with cancer. Previous reviews have identified these various applications and solutions, but no review has summarized the quality, feasibility, and efficacy of existing patient platforms (inclusive of websites, mobile technologies, mHealth and eHealth platforms) developed specifically for young people with cancer. Objective This paper describes the design of a protocol to conduct a review of published studies or reports which describe or report on an existing platform designed specifically for AYAs who have had a cancer diagnosis. Methods A search string was developed using a variety of key words and Medical Subject Heading and applied to bibliographic databases. General data (sample characteristics, patient platform development, design and, if applicable, pilot testing outcomes) will be extracted from reports and studies. Drawing on a previously developed coding schematic, the identified patient platforms will be coded for mode of delivery into (1) automated functions, (2) communicative functions, and (3) use of supplementary modes. An adapted version of the Mobile App Rating Scale (MARS) will be used to assess the of quality of each identified patient platform. The methodological quality of included studies will be assessed using the Quality Assessment Criteria for Evaluating Primary Research Papers from a Variety of Fields (QualSyst). Both authors will independently screen eligible studies for final inclusion and will both be responsible for data extraction and appraisal. Data will be synthesized narratively to provide an overview of identified patient platforms. Results The review began in October 2016 and is currently in progress. The review paper will be submitted for peer-review and publication in the summer of 2017. Conclusions This review will be unique in its focus on assessing, where possible, the

Pre-flight evaluation of adult patients with cystic fibrosis: a cross-sectional study.

PubMed

Edvardsen, Elisabeth; Akerø, Aina; Skjønsberg, Ole Henning; Skrede, Bjørn

2017-02-06

Air travel may imply a health hazard for patients with cystic fibrosis (CF) due to hypobaric environment in the aircraft cabin. The objective was to identify pre-flight variables, which might predict severe hypoxaemia in adult CF patients during air travel. Thirty adult CF-patients underwent pre-flight evaluation with spirometry, arterial oxygen tension (PaO 2 ), pulse oximetry (SpO 2 ) and cardiopulmonary exercise testing (CPET) at sea level (SL). The results were related to the PaO 2 obtained during a hypoxia-altitude simulation test (HAST) in which a cabin altitude of 2438 m (8000 ft) was simulated by breathing 15.1% oxygen. Four patients fulfilled the criteria for supplemental oxygen during air travel (PaO 2 HAST  < 6.6 kPa). While walking slowly during HAST, another eleven patients dropped below PaO 2 HAST 6.6 kPa. Variables obtained during CPET (PaO 2 CPET , SpO 2 CPET , minute ventilation/carbon dioxide output, maximal oxygen uptake) showed the strongest correlation to PaO 2 HAST . Exercise testing might be of value for predicting in-flight hypoxaemia and thus the need for supplemental oxygen during air travel in CF patients. Trial registration The study is retrospectively listed in the ClinicalTrials.gov Protocol Registration System: NCT01569880 (date; 30/3/2012).

Internet-based Mindfulness Meditation for Cognition and Mood in Older Adults: A Pilot Study.

PubMed

Wahbeh, Helané; Goodrich, Elena; Oken, Barry S

2016-01-01

Older adults are at risk for greater chronic stress and cognitive decline. Training in mindfulness meditation (MM) may help reduce stress and, thus, cognitive decline in older adults, but little research has explored that hypothesis. The current study's primary aim was to evaluate the feasibility and acceptability for use by older adults of the Internet Mindfulness Meditation Intervention (IMMI), a program that had been developed by the research team, as well as of an Internet-based health-and-wellness education program, the control. The secondary aim was to collect preliminary pre- and postintervention data on mood and cognitive function. The study was a randomized, controlled trial (RCT), a pilot study, with participants randomized either to the meditation group or the education group. Participants obtained access to the programs from their homes, and the baseline and endpoint assessments occurred in their homes as well. Older adults aged 65-90 y were recruited from the Portland, OR, metropolitan area. Twenty-one people enrolled in the study. Participants in both groups took part in a 1-h online session each week for 6 wk, with 30 min of daily home practice. Feasibility and acceptability were assessed through measures of adherence to the protocol and a client satisfaction questionnaire. Mood and cognitive outcomes were also evaluated before and after the interventions. Sixteen participants completed the study, 8 in each group, and 5 dropped out, for a 76% completion rate. Participants' mean age was 76.2 y; 88% were Caucasian, and 50% were female. Acceptability was high for the interventions, based on above-average scores on the client satisfaction questionnaire. The IMMI participants completed (1) 4.25 ± 2.4 sessions, with a range of 0-6; (2) 604 ± 506 home-practice minutes, with a range 0-1432; and (3) 21.3 ± 15.5 d of practice, with a range of 0-46. The education group completed (1) 4.75 ± 1.8 sessions, with a range of 2-6; (2) 873 ± 395 home

The Norwegian Healthy Life Study: protocol for a pragmatic RCT with longitudinal follow-up on physical activity and diet for adults.

PubMed

Abildsnes, Eirik; Meland, Eivind; Mildestvedt, Thomas; Stea, Tonje H; Berntsen, Sveinung; Samdal, Gro Beate

2017-01-05

The Norwegian Directorate of Health recommends that Healthy Life Centres (HLCs) be established in primary health care to support behaviour change and reduce the risk of non-communicable diseases. The aim of the present study protocol is to present the rationale, design and methods of a combined pragmatic randomized controlled trial (RCT) and longitudinal cohort study of the effects of attending HLCs concerning physical activity, sedentary behaviour and diet and to explore how psychological well-being and motivational factors may mediate short- and long-term effects. The present study will combine a 6-month RCT with a longitudinal cohort study (24 months from baseline) conducted at six HLCs from June 2014 to Sept 2017. Participants are randomized to behavioural change interventions or a 6-month waiting list control group. A randomized trial of interventions in HLCs has the potential to influence the development of policy and practice for behaviour change interventions and patient education programmes in Norway. We discuss some of the important preconditions for obtaining valid results from a complex intervention and outline some of the characteristics of ecological approaches in health care research that can enable a pragmatic intervention study. The study was retrospectively registered on September 19, 2014 and is available online at ClinicalTrials.gov (ID: NCT02247219 ).

Prenatal diagnosis and prevention of toxoplasmosis in pregnant women in Northern Vietnam: study protocol.

PubMed

Smit, G Suzanne A; Vu, Thi Lam Binh; Do, Trung Dung; Speybroeck, Niko; Devleesschauwer, Brecht; Padalko, Elizaveta; Roets, Ellen; Dorny, Pierre

2017-05-25

In Vietnam, no systematic prenatal toxoplasmosis screening is in place, and only few studies have assessed the prevalence and importance of this zoonotic parasite infection. In addition, no studies have been conducted to assess the risk factors associated with toxoplasmosis. This study protocol was developed to determine the seroprevalence of toxoplasmosis in pregnant women in Hanoi and Thai Binh, Northern Vietnam, and to evaluate the association with risk factors and congenital toxoplasmosis. The protocol was developed in a way that it could potentially evolve into a countrywide prenatal diagnosis and prevention program, with the main focus on primary prevention. The collaborating gynaecologists will invite eligible pregnant women attending antenatal care for the first time to participate in the study. At first consult, information about toxoplasmosis and its prevention will be provided. All participants will be asked to fill in a questionnaire, which is designed to analyse socio-demographic and biologically plausible risk factors associated with toxoplasmosis, and blood samples will be collected to determine the seroprevalence of toxoplasmosis in pregnant women. In case there is suspicion of a primary infection during pregnancy, the concerned women will be followed-up by the gynaecologists according to a predefined protocol. Every participant will be informed on her serological status, risk factors and prevention measures and is offered appropriate medical information and medical follow-up if required. The hypothesis is that congenital toxoplasmosis is an important but currently under-diagnosed public health problem in Vietnam. This study can strengthen sustainable control of toxoplasmosis in Vietnam, provide a protocol for prenatal diagnosis, boost overall awareness, improve the knowledge about toxoplasmosis prevention and can be essential for evidence-based health policy.

Management of older adults with hip fractures in India: a mixed methods study of current practice, barriers and facilitators, with recommendations to improve care pathways.

PubMed

Rath, Santosh; Yadav, Lalit; Tewari, Abha; Chantler, Tracey; Woodward, Mark; Kotwal, Prakash; Jain, Anil; Dey, Aparajit; Garg, Bhavuk; Malhotra, Rajesh; Goel, Ashish; Farooque, Kamran; Sharma, Vijay; Webster, Premila; Norton, Robyn

2017-12-01

Evidence-based management can reduce deaths and suffering of older adults with hip fractures. This study investigates the evidence-practice gaps in hip fracture care in three major hospitals in Delhi, potential barriers and facilitators to improving care, and consequently, identifies contextually appropriate interventions for implementing best practice for management of older adults with hip fractures in India. Hip fracture in older adults is a significant public health issue in India. The current study sought to document current practices, identify barriers and facilitators to adopting best practice guidelines and recommend improvements in the management of older adults with hip fractures in Delhi, India. This mixed methods observational study collected data from healthcare providers, patients, carers and medical records from three major public tertiary care hospitals in Delhi, India. All patients aged ≥50 years with an X-ray confirmed hip fracture that were admitted to these hospitals over a 10-week period were recruited. Patients' data were collected at admission, discharge and 30 days post-injury. Eleven key informant interviews and four focus group discussions were conducted with healthcare providers. Descriptive data for key quantitative variables were computed. The qualitative data were analysed and interpreted using a behaviour change wheel framework. A total of 136 patients, 74 (54%) men and 62 women, with hip fracture were identified in the three participating hospitals during the recruitment period and only 85 (63%) were admitted for treatment with a mean age of 66.5 years (SD 11.9). Of these, 30% received surgery within 48 h of hospital admission, 95% received surgery within 39 days of hospital admission and two (3%) had died by 30 days of injury. According to the healthcare providers, inadequate resources and overcrowding prevent adequate caring of the hip fracture patients. They unanimously felt the need for protocol-based management of hip

Study protocol to assess the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units: a cluster-randomised, crossover trial (The ICU Visits Study).

PubMed

Rosa, Regis Goulart; Falavigna, Maicon; Robinson, Caroline Cabral; da Silva, Daiana Barbosa; Kochhann, Renata; de Moura, Rafaela Moraes; Santos, Mariana Martins Siqueira; Sganzerla, Daniel; Giordani, Natalia Elis; Eugênio, Cláudia; Ribeiro, Tarissa; Cavalcanti, Alexandre Biasi; Bozza, Fernando; Azevedo, Luciano Cesar Pontes; Machado, Flávia Ribeiro; Salluh, Jorge Ibrain Figueira; Pellegrini, José Augusto Santos; Moraes, Rafael Barberena; Hochegger, Taís; Amaral, Alexandre; Teles, José Mario Meira; da Luz, Lucas Gobetti; Barbosa, Mirceli Goulart; Birriel, Daniella Cunha; Ferraz, Iris de Lima; Nobre, Vandack; Valentim, Helen Martins; Corrêa E Castro, Livia; Duarte, Péricles Almeida Delfino; Tregnago, Rogério; Barilli, Sofia Louise Santin; Brandão, Nilton; Giannini, Alberto; Teixeira, Cassiano

2018-04-13

Flexible intensive care unit (ICU) visiting hours have been proposed as a means to improve patient-centred and family-centred care. However, randomised trials evaluating the effects of flexible family visitation models (FFVMs) are scarce. This study aims to compare the effectiveness and safety of an FFVM versus a restrictive family visitation model (RFVM) on delirium prevention among ICU patients, as well as to analyse its potential effects on family members and ICU professionals. A cluster-randomised crossover trial involving adult ICU patients, family members and ICU professionals will be conducted. Forty medical-surgical Brazilian ICUs with RFVMs (<4.5 hours/day) will be randomly assigned to either an RFVM (visits according to local policies) or an FFVM (visitation during 12 consecutive hours per day) group at a 1:1 ratio. After enrolment and follow-up of 25 patients, each ICU will be switched over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome will be the cumulative incidence of delirium among ICU patients, measured twice a day using the Confusion Assessment Method for the ICU. Secondary outcome measures will include daily hazard of delirium, ventilator-free days, any ICU-acquired infections, ICU length of stay and hospital mortality among the patients; symptoms of anxiety and depression and satisfaction among the family members; and prevalence of burnout symptoms among the ICU professionals. Tertiary outcomes will include need for antipsychotic agents and/or mechanical restraints, coma-free days, unplanned loss of invasive devices and ICU-acquired pneumonia, urinary tract infection or bloodstream infection among the patients; self-perception of involvement in patient care among the family members; and satisfaction among the ICU professionals. The study protocol has been approved by the research ethics committee of all participant institutions. We aim to disseminate the findings through

Body Mass Index, Sex, Interview Protocol, and Children’s Accuracy for Reporting Kilocalories Observed Eaten at School Meals

PubMed Central

Baxter, Suzanne Domel; Smith, Albert F.; Litaker, Mark S.; Guinn, Caroline H.; Nichols, Michele D.; Miller, Patricia H.; Kipp, Katherine

2008-01-01

This pilot study investigated body mass index (BMI), sex, interview protocol, and children’s accuracy for reporting kilocalories. Forty fourth-grade children (20 low BMI [LBMI; ≥5th and <50th percentiles; 10 boys; 15 black], 20 high BMI [HBMI;≥ 85th percentile; 10 boys; 15 black]) were observed eating school meals (breakfast, lunch) and interviewed either that evening about the prior 24 hours (24E) or the next morning about the previous day (PDM), with 10 LBMI (5 boys) and 10 HBMI (5 boys) per interview protocol. Five kilocalorie variables were analyzed using separate 4-factor (BMI group, sex, race, interview protocol) analyses of variance. No effects were found for reported or matched kilocalories. More kilocalories were observed (p<0.02) and omitted (p<0.05) by HBMI than LBMI children. For intruded kilocalories, means were smaller (better) for HBMI girls than HBMI boys, but larger for LBMI girls than LBMI boys (interaction p<0.04); LBMI girls intruded the most while HBMI girls intruded the least. For interview protocol, omitted and intruded kilocalories were higher (worse), although not significantly so (ps<0.11), for PDM than 24E. These results illuminate relations of BMI, sex, interview protocol, and children’s reporting accuracy, and are consistent with results concerning BMI and sex from studies with adults. PMID:17000199

A Preliminary Study of the Effects of a Multitheory-Driven Intervention in Adults With Prediabetes Mellitus.

PubMed

Tsai, Fu-Mian; Lin, Chiu-Chu; Lin, Huey-Shyan; Liu, Yi

2018-06-01

Prediabetes mellitus (pre-DM) is an important predictive indicator of Type 2 diabetes. A person with pre-DM is eight times more likely to develop diabetes than a person without pre-DM. Prior research suggests that proactive interventions may delay the progression of this disease and reduce the rate of disease development. The purposes of this preliminary study were to develop a multitheory-driven lifestyle intervention protocol for adults with pre-DM and to evaluate its feasibility and impacts on knowledge regarding pre-DM, dietary behaviors, and physical activity (primary outcomes) as well as to describe the disease progression indicators (secondary outcomes). A single-group, longitudinal study design was used. Thirty-nine participants were included in the analysis. A generalized estimating equation model was used to determine the trends in changes in the outcomes. All of the participants underwent testing at baseline (T0) and at 3 (T1), 6 (T2), and 12 (T3) months after the 4-week lifestyle intervention. There were significantly increasing trends for each study parameter (Pre-DM Knowledge Assessment Form-12, p < .01; Dietary Behavior Scale, p < .01) and significantly positive changes in body weight (p < .01), body mass index (p < .01), fasting glucose level (p < .01), and glycated hemoglobin level (p < .01) over the 12-month study period. This study supports the feasibility of the developed multitheory-driven lifestyle intervention protocol and suggests that its application may improve the effectiveness of diabetes prevention programs in clinical settings. Further randomized controlled trials are needed.

Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study).

PubMed

McNally, Dayre; Amrein, Karin; O'Hearn, Katharine; Fergusson, Dean; Geier, Pavel; Henderson, Matt; Khamessan, Ali; Lawson, Margaret L; McIntyre, Lauralyn; Redpath, Stephanie; Weiler, Hope A; Menon, Kusum

2017-01-01

Clinical research has recently demonstrated that vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (PICU) and associated with worse clinical course. Multiple adult ICU trials have suggested that optimization of vitamin D status through high-dose supplementation may reduce mortality and improve other clinically relevant outcomes; however, there have been no trials of rapid normalization in the PICU setting. The objective of this study is to evaluate the safety and efficacy of an enteral weight-based cholecalciferol loading dose regimen in critically ill children with VDD. The VITdAL-PICU pilot study is designed as a multicenter placebo-controlled phase II dose evaluation pilot randomized controlled trial. We aim to randomize 67 VDD critically ill children using a 2:1 randomization schema to receive loading dose enteral cholecalciferol (10,000 IU/kg, maximum of 400,000 IU) or a placebo solution. Participants, caregivers and outcome assessors will be blinded to allocation. Eligibility criteria include ICU patient, aged 37 weeks to 18 years, expected ICU length of stay more than 48 h, anticipated access to bloodwork at 7 days, and VDD (blood total 25 hydroxyvitamin D < 50 nmol/L). The primary objective is to determine whether the dosing protocol normalizes vitamin D status, defined as a blood total 25(OH)D concentration above 75 nmol/L. Secondary objectives include an examination of the safety of the dosing regimen (e.g. hypercalcemia, hypercalciuria, nephrocalcinosis), measures of vitamin D axis function (e.g. calcitriol levels, immune function), and protocol feasibility (eligibility criteria, protocol deviations, blinding). Despite significant observational literature suggesting VDD to be a modifiable risk factor in the PICU setting, there is no robust clinical trial evidence evaluating the benefits of rapid normalization. This phase II clinical trial will evaluate an innovative weight-based dosing regimen intended to

Assumptions, Trust, and Names in Computer Security Protocols

DTIC Science & Technology

2011-06-01

sharing her banking credentials with a criminal, which is clearly bad . But PKI proto- cols like this one can be used in other, less risky ways. Suppose...Figure 4.5. This is similar to a failure of PKI-based protocols in which the authority signs a bad certificate. But the interesting thing is how the... Zoo Figure 4.6: Using AdultVerify. The run is as follows: 1. As the first step in Diffie-Hellman Key Exchange, Alice picks and sends the

Investigating the Impact of Hearing Aid Use and Auditory Training on Cognition, Depressive Symptoms, and Social Interaction in Adults With Hearing Loss: Protocol for a Crossover Trial.

PubMed

Nkyekyer, Joanna; Meyer, Denny; Blamey, Peter J; Pipingas, Andrew; Bhar, Sunil

2018-03-23

Sensorineural hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression, and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. Hearing aids have been proven as successful interventions to alleviate sensorineural hearing loss. In addition to hearing aid use, the positive effects of auditory training-formal listening activities designed to optimize speech perception-are now being documented among adults with hearing loss who use hearing aids, especially new hearing aid users. Auditory training has also been shown to produce prolonged cognitive performance improvements. However, there is still little evidence to support the benefits of simultaneous hearing aid use and individualized face-to-face auditory training on cognitive performance in adults with hearing loss. This study will investigate whether using hearing aids for the first time will improve the impact of individualized face-to-face auditory training on cognition, depression, and social interaction for adults with sensorineural hearing loss. The rationale for this study is based on the hypothesis that, in adults with sensorineural hearing loss, using hearing aids for the first time in combination with individualized face-to-face auditory training will be more effective for improving cognition, depressive symptoms, and social interaction rather than auditory training on its own. This is a crossover trial targeting 40 men and women between 50 and 90 years of age with either mild or moderate symmetric sensorineural hearing loss. Consented, willing participants will be recruited from either an independent living accommodation or via a community database to undergo a 6-month intensive face-to-face auditory training program (active control). Participants will be assigned in random order to receive hearing aid (intervention) for

Does adopting a prenatal substance use protocol reduce racial disparities in CPS reporting related to maternal drug use? A California case study.

PubMed

Roberts, S C M; Zahnd, E; Sufrin, C; Armstrong, M A

2015-02-01

This study examined whether adopting a standardized prenatal substance use protocol (protocol) in a hospital labor and delivery unit reduced racial disparities in reporting to child protective services (CPS) related to maternal drug use during pregnancy. This study used an interrupted time series design with a non-equivalent control. One hospital adopted a protocol and another hospital group serving a similar geographic population did not change protocols. Data on CPS reporting disparities from these hospitals over 3.5 years were analyzed using segmented regression. In the hospital that adopted the protocol, almost five times more black than white newborns were reported during the study period. Adopting the protocol was not associated with reduced disparities. Adopting a protocol cannot be assumed to reduce CPS reporting disparities. Efforts to encourage hospitals to adopt protocols as a strategy to reduce disparities may be misguided. Other strategies to reduce disparities are needed.

Case Studies in Environmental Adult and Popular Education.

ERIC Educational Resources Information Center

Clover, Darlene E., Ed.; Follen, Shirley, Ed.

Following an introduction by Darlene E. Clover and Rene Karottki, this booklet provides 16 case studies about nonformal environmental adult education: "Environment and Development in Argentina: Innovative Experiences in Adult Learning" (Raul A. Montenegro); "Learning for Environmental Action: Environmental Adult and Popular Education in Canada"…

[Long-term destiny of adolescents and young adults with de novo acute lymphoblastic leukemia treated with a pediatric protocol type].

PubMed

López-Hernández, Manuel Antonio; Alvarado-Ibarra, Martha; Álvarez-Veral, José Luis; Ortiz-Zepeda, Maricela; Guajardo-Leal, Martha Lilia; Cota-Range, Xochitl

The prognosis, in the long term, of adolescents and young adults with acute de novo lymphoblastic leukemia, treated with a pediatric type protocol. To analyze the efficacy and tolerability of a chemotherapy regimen of pediatric type on patients 15-35 years old with de novo acute lymphoblastic leukemia, Ph(-). A retrospective study of patients received from 2001 to 2013, without initial infiltration of the central nervous system. They received the regimen called LALÍN. Terminal goals: frequency of initial remission, probability of survival free of leukemia and event-free survival for five years. We included 101 patients; there were 29 relapses and 19 deaths. There was initial remission in 97% of the cases; survival free of leukemia of 0.58 and event-free survival 0.44. No difference in patients aged 16-21 years vs. 22-35 (p > 0.55). Negative prognostic factors: abnormal karyotypes, except hyperdiploids (p = 0.001); > 5% of blasts, on 14 day induction (p = 0. 0001); delay in the punctuality of the courses of the chemotherapy regimen (p = 0.0001). A pediatric type regimen is applicable to patients aged from 16 to 35 years with acute lymphoblastic leukemia, without greater toxicity and a best survival free of leukemia. The count of > 5% of blasts and the delay in the execution of the stages of the chemotherapy regimen are the stronger negative prognostic factors.

Using patients’ experiences of adverse events to improve health service delivery and practice: protocol of a data linkage study of Australian adults age 45 and above

PubMed Central

Walton, Merrilyn; Smith-Merry, Jennifer; Harrison, Reema; Manias, Elizabeth; Iedema, Rick; Kelly, Patrick

2014-01-01

Introduction Evidence of patients’ experiences is fundamental to creating effective health policy and service responses, yet is missing from our knowledge of adverse events. This protocol describes explorative research redressing this significant deficit; investigating the experiences of a large cohort of recently hospitalised patients aged 45 years and above in hospitals in New South Wales (NSW), Australia. Methods and analysis The 45 and Up Study is a cohort of 265 000 adults aged 45 years and above in NSW. Patients who were hospitalised between 1 January and 30 June 2014 will be identified from this cohort using data linkage and a random sample of 20 000 invited to participate. A cross-sectional survey (including qualitative and quantitative components) will capture patients’ experiences in hospital and specifically of adverse events. Approximately 25% of respondents are likely to report experiencing an adverse event. Quantitative components will capture the nature and type of events as well as common features of patients’ experiences. Qualitative data provide contextual knowledge of their condition and care and the impact of the event on individuals. Respondents who do not report an adverse event will report their experience in hospital and be the control group. Statistical and thematic analysis will be used to present a patient perspective of their experiences in hospital; the characteristics of patients experiencing an adverse event; experiences of information sharing after an event (open disclosure) and the other avenues of redress pursued. Interviews with key policymakers and a document analysis will be used to create a map of the current practice. Ethics and dissemination Dissemination via a one-day workshop, peer-reviewed publications and conference presentations will enable effective clinical responses and service provision and policy responses to adverse events to be developed. PMID:25311039

Using patients' experiences of adverse events to improve health service delivery and practice: protocol of a data linkage study of Australian adults age 45 and above.

PubMed

Walton, Merrilyn; Jorm, Christine; Smith-Merry, Jennifer; Harrison, Reema; Manias, Elizabeth; Iedema, Rick; Kelly, Patrick

2014-10-13

Evidence of patients' experiences is fundamental to creating effective health policy and service responses, yet is missing from our knowledge of adverse events. This protocol describes explorative research redressing this significant deficit; investigating the experiences of a large cohort of recently hospitalised patients aged 45 years and above in hospitals in New South Wales (NSW), Australia. The 45 and Up Study is a cohort of 265,000 adults aged 45 years and above in NSW. Patients who were hospitalised between 1 January and 30 June 2014 will be identified from this cohort using data linkage and a random sample of 20,000 invited to participate. A cross-sectional survey (including qualitative and quantitative components) will capture patients' experiences in hospital and specifically of adverse events. Approximately 25% of respondents are likely to report experiencing an adverse event. Quantitative components will capture the nature and type of events as well as common features of patients' experiences. Qualitative data provide contextual knowledge of their condition and care and the impact of the event on individuals. Respondents who do not report an adverse event will report their experience in hospital and be the control group. Statistical and thematic analysis will be used to present a patient perspective of their experiences in hospital; the characteristics of patients experiencing an adverse event; experiences of information sharing after an event (open disclosure) and the other avenues of redress pursued. Interviews with key policymakers and a document analysis will be used to create a map of the current practice. Dissemination via a one-day workshop, peer-reviewed publications and conference presentations will enable effective clinical responses and service provision and policy responses to adverse events to be developed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Space Fortress game training and executive control in older adults: A pilot intervention

PubMed Central

Stern, Yaakov; Blumen, Helena M.; Rich, Leigh W.; Richards, Alexis; Herzberg, Gray; Gopher, Daniel

2012-01-01

We investigated the feasibility of using the Space Fortress (SF) game, a complex video game originally developed to study complex skill acquisition in young adults, to improve executive control processes in cognitively healthy older adults. The study protocol consisted of 36 one-hour game play sessions over 3 months with cognitive evaluations before and after, and a follow-up evaluation at 6 months. Sixty participants were randomized to one of three conditions: Emphasis Change (EC) – elders were instructed to concentrate on playing the entire game but place particular emphasis on a specific aspect of game play in each particular game; Active Control (AC) – game play with standard instructions; Passive Control (PC) – evaluation sessions without game play. Primary outcome measures were obtained from five tasks, presumably tapping executive control processes. A total of 54 older adults completed the study protocol. One measure of executive control, WAIS-III letter–number sequencing, showed improvement in performance from pre- to post-evaluations in the EC condition, but not in the other two conditions. These initial findings are modest but encouraging. Future SF interventions need to carefully consider increasing the duration and or the intensity of the intervention by providing at-home game training, reducing the motor demands of the game, and selecting appropriate outcome measures. PMID:21988726

Regional gastrointestinal transit and pH studied in 215 healthy volunteers using the wireless motility capsule: influence of age, gender, study country and testing protocol.

PubMed

Wang, Y T; Mohammed, S D; Farmer, A D; Wang, D; Zarate, N; Hobson, A R; Hellström, P M; Semler, J R; Kuo, B; Rao, S S; Hasler, W L; Camilleri, M; Scott, S M

2015-09-01

The wireless motility capsule (WMC) offers the ability to investigate luminal gastrointestinal (GI) physiology in a minimally invasive manner. To investigate the effect of testing protocol, gender, age and study country on regional GI transit times and associated pH values using the WMC. Regional GI transit times and pH values were determined in 215 healthy volunteers from USA and Sweden studied using the WMC over a 6.5-year period. The effects of test protocol, gender, age and study country were examined. For GI transit times, testing protocol was associated with differences in gastric emptying time (GET; shorter with protocol 2 (motility capsule ingested immediately after meal) vs. protocol 1 (motility capsule immediately before): median difference: 52 min, P = 0.0063) and colonic transit time (CTT; longer with protocol 2: median 140 min, P = 0.0189), but had no overall effect on whole gut transit time. Females had longer GET (by median 17 min, P = 0.0307), and also longer CTT by (104 min, P = 0.0285) and whole gut transit time by (263 min, P = 0.0077). Increasing age was associated with shorter small bowel transit time (P = 0.002), and study country also influenced small bowel and CTTs. Whole gut and CTTs showed clustering of data at values separated by 24 h, suggesting that describing these measures as continuous variables is invalid. Testing protocol, gender and study country also significantly influenced pH values. Regional GI transit times and pH values, delineated using the wireless motility capsule (WMC), vary based on testing protocol, gender, age and country. Standardisation of testing is crucial for cross-referencing in clinical practice and future research. © 2015 John Wiley & Sons Ltd.

Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial.

PubMed

Beck, Anne Marie; Gøgsig Christensen, Annette; Stenbæk Hansen, Birthe; Damsbo-Svendsen, Signe; Kreinfeldt Skovgaard Møller, Tina; Boll Hansen, Eigil; Keiding, Hans

2014-08-28

Older adults in nursing home and home-care are a particularly high-risk population for weight loss or poor nutrition. One negative consequence of undernutrition is increased health care costs. Several potentially modifiable nutritional risk factors increase the likelihood of weight loss or poor nutrition. Hence a structured and multidisciplinary approach, focusing on the nutritional risk factors and involving e.g. dieticians, occupational therapists, and physiotherapist, may be necessary to achieve benefits. Up till now a few studies have been done evaluating the cost-effectiveness of nutritional support among undernourished older adults and none of these have used such a multidisciplinary approach. An 11 week cluster randomized trial to assess the cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care, identified by screening with the Eating validation Scheme. Before start of the study there will be performed a train-the-trainer intervention involving educated nutrition coordinators.In addition to the nutrition coordinator, the participants assigned to the intervention group strategy will receive multidisciplinary nutrition support. Focus will be on treatment of the potentially modifiable nutritional risk factors identified by screening, by involving physiotherapist, registered dietician, and occupational therapist, as relevant and independent of the municipality's ordinary assessment and referral system.The primary outcome parameter will be change in quality of life (by means of Euroquol-5D-3L). Secondary outcomes will be: physical performance (chair stand), nutritional status (weight, Body Mass Index and hand-grip strength), oral care, fall incidents, hospital admissions, rehabilitation stay, moving to nursing homes (for participants from home-care), use of social services and mortality.An economic evaluation will be conducted to evaluate the cost-effectiveness of the multidisciplinary

Adherence to, and outcomes of, a galactomannan screening protocol in high-risk hematology patients.

PubMed

Harricharan, S; Biederman, K; Bombassaro, A M; Lazo-Langner, A; Elsayed, S; Fulford, A; Delport, J A; Xenocostas, A

2018-04-01

A twice-weekly galactomannan (gm) screening protocol was implemented in high-risk hematology inpatients. Study objectives were to determine adherence to the protocol, use of selected resources, and patient outcomes. This retrospective cohort study compared outcomes of interest before and after implementation of gm screening. Adults undergoing matched related allogeneic hematopoietic stem-cell transplantation or induction chemotherapy for acute leukemia were eligible. Patients could be enrolled more than once and were evaluated as episodes. Adherence to the gm protocol was assessed in post-implementation episodes. Use of broad-spectrum antifungals (bsafs), consultations (infectious diseases, respirology), and diagnostic procedures (computed tomography imaging, bronchoalveolar lavage) were compared between phases, as were the patient outcomes of all-cause mortality and clinical success (alive and not taking a bsaf). Of 182 episodes consecutively screened, 70 per phase were enrolled. Clinical characteristics and duration of assessment were similar for the phases. Full or partial adherence to the protocol was observed in 61 post-implementation episodes (87%), with full adherence in 40 episodes (57%). More episodes in the pre-implementation phase than in the post-implementation phase involved receipt of bsafs, consultations, and diagnostics (27% vs. 7%, p = 0.02; 46% vs. 26%, p = 0.014; and 46% vs. 31%, p = 0.083 respectively). Although mortality was similar in the two phases, clinical success at the final assessment was observed in fewer pre-implementation than post-implementation episodes (79% vs. 98%, p < 0.001). Implementation of a gm screening protocol was feasible and associated with significantly fewer episodes involving receipt of bsafs and consultations, and with significantly more episodes showing clinical success.

A land classification protocol for pollinator ecology research: An urbanization case study.

PubMed

Samuelson, Ash E; Leadbeater, Ellouise

2018-06-01

Land-use change is one of the most important drivers of widespread declines in pollinator populations. Comprehensive quantitative methods for land classification are critical to understanding these effects, but co-option of existing human-focussed land classifications is often inappropriate for pollinator research. Here, we present a flexible GIS-based land classification protocol for pollinator research using a bottom-up approach driven by reference to pollinator ecology, with urbanization as a case study. Our multistep method involves manually generating land cover maps at multiple biologically relevant radii surrounding study sites using GIS, with a focus on identifying land cover types that have a specific relevance to pollinators. This is followed by a three-step refinement process using statistical tools: (i) definition of land-use categories, (ii) principal components analysis on the categories, and (iii) cluster analysis to generate a categorical land-use variable for use in subsequent analysis. Model selection is then used to determine the appropriate spatial scale for analysis. We demonstrate an application of our protocol using a case study of 38 sites across a gradient of urbanization in South-East England. In our case study, the land classification generated a categorical land-use variable at each of four radii based on the clustering of sites with different degrees of urbanization, open land, and flower-rich habitat. Studies of land-use effects on pollinators have historically employed a wide array of land classification techniques from descriptive and qualitative to complex and quantitative. We suggest that land-use studies in pollinator ecology should broadly adopt GIS-based multistep land classification techniques to enable robust analysis and aid comparative research. Our protocol offers a customizable approach that combines specific relevance to pollinator research with the potential for application to a wide range of ecological questions

Pharmacological properties of various anesthetic protocols in 10-day-old neonatal rats.

PubMed

Tsukamoto, Atsushi; Konishi, Yui; Kawakami, Takako; Koibuchi, Chiharu; Sato, Reiichiro; Kanai, Eiichi; Inomata, Tomo

2017-10-30

In general, the anesthesia in neonates involves high risk. Although hypothermic anesthesia is recommended in rats up to the age of 7 days, neonatal anesthesia for later periods has not been standardized. The present study investigated the pharmacological properties of conventional anesthetic protocols in 10-day-old SD rats. The rats were anesthetized with four anesthetics: a combination of ketamine and xylazine (K/X); a combination of medetomidine, midazolam, and butorphanol (M/M/B); isoflurane; and sevoflurane. Anesthetic depth was scored by reflex response to noxious stimuli. Induction and recovery times were recorded. Vital signs and mortality rate were evaluated for safety assessment. All rats died after administration of K/X at a dose of 60/6 mg/kg, whereas K/X at 40/4 mg/kg resulted in insufficient anesthetic depth, indicating inappropriate for neonatal anesthesia. Although M/M/B at the adult rat dose (0.15/2/2.5 mg/kg) did not provide surgical anesthetic depth, the mouse dose (0.3/4/5 mg/kg) showed sufficient anesthetic depth with relatively stable vital signs. Isoflurane required a long induction period, and caused remarkable respiratory depression and hypothermia, resulted in a 25% mortality rate. In contrast, sevoflurane provided consistent surgical anesthetic depth with rapid induction. Although respiratory rate decrease was markedly observed, all rats survived. Among the anesthetic protocols investigated in the present study, sevoflurane and M/M/B at the mouse dose were recommended for the neonatal anesthesia. Compared with adult rats, the required dose of both anesthetics in neonates was higher, possibly associated with their lower anesthetic sensitivity.

Purified enzymes improve isolation and characterization of the adult thymic epithelium.

PubMed

Seach, Natalie; Wong, Kahlia; Hammett, Maree; Boyd, Richard L; Chidgey, Ann P

2012-11-30

The reproducible isolation and accurate characterization of thymic epithelial cell (TEC) subsets is of critical importance to the ongoing study of thymopoiesis and its functional decline with age. The study of adult TEC, however, is significantly hampered due to the severely low stromal to hematopoietic cell ratio. Non-biased digestion and enrichment protocols are thus essential to ensure optimal cell yield and accurate representation of stromal subsets, as close as possible to their in vivo representation. Current digestion protocols predominantly involve diverse, relatively impure enzymatic variants of crude collagenase and collagenase/dispase (col/disp) preparations, which have variable efficacy and are often suboptimal in their ability to mediate complete digestion of thymus tissue. To address these issues we compared traditional col/disp preparations with the latest panel of Liberase products that contain a blend of highly purified collagenase and neutral protease enzymes. Liberase enzymes revealed a more rapid, complete dissociation of thymus tissue; minimizing loss of viability and increasing recovery of thymic stromal cell (TSC) elements. In particular, the recovery and viability of TEC, notably the rare cortical subsets, were significantly enhanced with Liberase products containing medium to high levels of thermolysin. The improved stromal dissociation led to numerically increased TEC yield and total TEC RNA isolated from pooled digests of adult thymus. Furthermore, the increased recovery of TEC enhanced resolution and quantification of TEC subsets in both adult and aged mice, facilitating flow cytometric analysis on a per thymus basis. We further refined the adult TEC phenotype by correlating surface expression of known TEC markers, with expression of intracellular epithelial lineage markers, Keratin 5 and Keratin 8. The data reveal more extensive expression of K8 than previously recognized and indicates considerable heterogeneity still exists within

Real-Time QoS Routing Protocols in Wireless Multimedia Sensor Networks: Study and Analysis.

PubMed

Alanazi, Adwan; Elleithy, Khaled

2015-09-02

Many routing protocols have been proposed for wireless sensor networks. These routing protocols are almost always based on energy efficiency. However, recent advances in complementary metal-oxide semiconductor (CMOS) cameras and small microphones have led to the development of Wireless Multimedia Sensor Networks (WMSN) as a class of wireless sensor networks which pose additional challenges. The transmission of imaging and video data needs routing protocols with both energy efficiency and Quality of Service (QoS) characteristics in order to guarantee the efficient use of the sensor nodes and effective access to the collected data. Also, with integration of real time applications in Wireless Senor Networks (WSNs), the use of QoS routing protocols is not only becoming a significant topic, but is also gaining the attention of researchers. In designing an efficient QoS routing protocol, the reliability and guarantee of end-to-end delay are critical events while conserving energy. Thus, considerable research has been focused on designing energy efficient and robust QoS routing protocols. In this paper, we present a state of the art research work based on real-time QoS routing protocols for WMSNs that have already been proposed. This paper categorizes the real-time QoS routing protocols into probabilistic and deterministic protocols. In addition, both categories are classified into soft and hard real time protocols by highlighting the QoS issues including the limitations and features of each protocol. Furthermore, we have compared the performance of mobility-aware query based real-time QoS routing protocols from each category using Network Simulator-2 (NS2). This paper also focuses on the design challenges and future research directions as well as highlights the characteristics of each QoS routing protocol.

Real-Time QoS Routing Protocols in Wireless Multimedia Sensor Networks: Study and Analysis

PubMed Central

Alanazi, Adwan; Elleithy, Khaled

2015-01-01

Many routing protocols have been proposed for wireless sensor networks. These routing protocols are almost always based on energy efficiency. However, recent advances in complementary metal-oxide semiconductor (CMOS) cameras and small microphones have led to the development of Wireless Multimedia Sensor Networks (WMSN) as a class of wireless sensor networks which pose additional challenges. The transmission of imaging and video data needs routing protocols with both energy efficiency and Quality of Service (QoS) characteristics in order to guarantee the efficient use of the sensor nodes and effective access to the collected data. Also, with integration of real time applications in Wireless Senor Networks (WSNs), the use of QoS routing protocols is not only becoming a significant topic, but is also gaining the attention of researchers. In designing an efficient QoS routing protocol, the reliability and guarantee of end-to-end delay are critical events while conserving energy. Thus, considerable research has been focused on designing energy efficient and robust QoS routing protocols. In this paper, we present a state of the art research work based on real-time QoS routing protocols for WMSNs that have already been proposed. This paper categorizes the real-time QoS routing protocols into probabilistic and deterministic protocols. In addition, both categories are classified into soft and hard real time protocols by highlighting the QoS issues including the limitations and features of each protocol. Furthermore, we have compared the performance of mobility-aware query based real-time QoS routing protocols from each category using Network Simulator-2 (NS2). This paper also focuses on the design challenges and future research directions as well as highlights the characteristics of each QoS routing protocol. PMID:26364639

Quarantine and protocol

NASA Technical Reports Server (NTRS)

1981-01-01

The purpose of the Orbiting Quarantine Facility is to provide maximum protection of the terrestrial biosphere by ensuring that the returned Martian samples are safe to bring to Earth. The protocol designed to detect the presence of biologically active agents in the Martian soil is described. The protocol determines one of two things about the sample: (1) that it is free from nonterrestrial life forms and can be sent to a terrestrial containment facility where extensive chemical, biochemical, geological, and physical investigations can be conducted; or (2) that it exhibits "biological effects" of the type that dictate second order testing. The quarantine protocol is designed to be conducted on a small portion of the returned sample, leaving the bulk of the sample undisturbed for study on Earth.

[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

PubMed

Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

2017-10-12

Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

Individual patient data meta-analysis of combined treatments versus psychotherapy (with or without pill placebo), pharmacotherapy or pill placebo for adult depression: a protocol.

PubMed

Weitz, Erica; Kleiboer, Annet; van Straten, Annemieke; Hollon, Steven D; Cuijpers, Pim

2017-02-13

There are many proven treatments (psychotherapy, pharmacotherapy or their combination) for the treatment of depression. Although there is growing evidence for the effectiveness of combination treatment (psychotherapy + pharmacotherapy) over pharmacotherapy alone, psychotherapy alone or psychotherapy plus pill placebo, for depression, little is known about which specific groups of patients may respond best to combined treatment versus monotherapy. Conventional meta-analyses techniques have limitations when tasked with examining whether specific individual characteristics moderate the effect of treatment on depression. Therefore, this protocol outlines an individual patient data (IPD) meta-analysis to explore which patients, with which clinical characteristics, have better outcomes in combined treatment compared with psychotherapy (alone or with pill placebo), pharmacotherapy and pill placebo. Study searches are completed using an established database of randomised controlled trials (RCTs) on the psychological treatment of adult depression that has previously been reported. Searches were conducted in PubMed, PsycInfo, Embase and the Cochrane Central Register of Controlled Trials. RCTs comparing combination treatment (psychotherapy + pharmacotherapy) with psychotherapy (with or without pill placebo), pharmacotherapy or pill placebo for the treatment of adult depression will be included. Study authors of eligible trials will be contacted and asked to contribute IPD. Conventional meta-analysis techniques will be used to examine differences between studies that have contributed data and those that did not. Then, IPD will be harmonised and analysis using multilevel regression will be conducted to examine effect moderators of treatment outcomes. Study results outlined above will be published in peer-reviewed journals. Study results will contribute to better understanding whether certain patients respond best to combined treatment or other depression treatments and provide

Improving pain treatment with a smartphone app: study protocol for a randomized controlled trial.

PubMed

Suso-Ribera, Carlos; Mesas, Ángela; Medel, Javier; Server, Anna; Márquez, Esther; Castilla, Diana; Zaragozá, Irene; García-Palacios, Azucena

2018-02-27

Chronic pain has become a major health problem across the world, especially in older adults. Unfortunately, the effectiveness of medical interventions is modest. Some have argued that assessment strategies should be improved if the impact of medical interventions is to be improved. Ecological momentary assessment using smartphones is now considered the gold standard in monitoring in health settings, including chronic pain. However, to the best of our knowledge, there is no randomized controlled trial to show that telemonitoring using a smartphone app can indeed improve the effectiveness of medical treatments in adults with chronic pain. The goal of this study will be to explore the effects of using a smartphone app for telemonitoring adults with chronic pain. The study will be a randomized controlled trial with three groups: treatment as usual (TAU), TAU+app, and TAU+app+alarms. All groups will receive the adequate treatment for their pain, which will be prescribed the first day of study according to clinical guidelines. Assessment in the TAU group will be the usual at the Pain Clinic, that is, a paper-and-pencil evaluation at the onset of treatment (beginning of study) and at follow up (end of study, 30 days later). The other two groups (TAU+app and TAU+app+alarms) will be assessed daily using Pain Monitor, a smartphone app developed by our multidisciplinary team. Telemonitoring will only be made in the TAU+app+alarms group. For this group, physicians at the Pain Clinic may decide to adjust pain treatment in response to alarms. Telemonitoring is not the usual practice at the Pain Clinic and will not occur in the other two groups (TAU and TAU+app), so no changes in treatment are expected in these groups after the first appointment. The total sample size will be 150, with 50 patients in each group. The assessment protocol will be the same in all groups and will include pain intensity and side effects of the medication (primary outcomes), together with several pain

Validation of the Pangao PG-800B26 upper arm blood pressure monitor in the general population according to the European Society of Hypertension and the British Hypertension Society protocols.

PubMed

Chen, Liang; Li, Jiyu; Wen, Jing; Guo, Changfeng; Zhang, Jingying; Yu, Zhen

2018-02-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor Pangao PG-800B26 for home blood pressure monitoring according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010 and the British Hypertension Society (BHS) protocols. Systolic and diastolic blood pressures were measured sequentially in 33 and 85 adults, respectively, on the basis of the ESH-IP and BHS protocols using a mercury sphygmomanometer (two observers) and the device (one supervisor). The procedures and analysis methods of the protocols were followed precisely. The device fulfilled the criteria of the ESH-IP, with device-observer differences of 1.01±5.16 and -0.58±4.17 mmHg for systolic and diastolic blood pressure, respectively. Furthermore, the A/A grade of the BHS protocol was also achieved for overall grading and for the three pressure levels, with average differences of 0.85±6.35 and -0.15±5.65 mmHg for systolic and diastolic blood pressure, respectively, which also fulfilled the requirements of the Association for the Advancement of Medical Instrumentation. The Pangao PG-800B26 fulfilled the criteria of the ESH-IP 2010 and achieved the A/A grade of the BHS protocol, and hence can be recommended for home use in adults.

Study protocol for the Cities Changing Diabetes programme: a global mixed-methods approach.

PubMed

Napier, A David; Nolan, John J; Bagger, Malene; Hesseldal, Louise; Volkmann, Anna-Maria

2017-11-08

Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many. The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through the Cities Changing Diabetes (CCD) partnership programme. A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan implementation of findings. Local academic teams execute the study following the global study protocol presented here. A quantitative Rule of Halves analysis obtains measures of the magnitude of the diabetes burden, the diagnosis rates in each city and the outcomes of care. A qualitative Diabetes Vulnerability Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. The protocol steers the collection of primary and secondary data across the study sites. Research ethics board approval has been sought and obtained in each site. Findings from each of the local studies as well as the result from combined multisite (global) analyses will be reported in a series of core scientific journal papers. © Article author

Treatment influencing down-staging in EORTC Melanoma Group sentinel node histological protocol compared with complete step-sectioning: a national multicentre study.

PubMed

Riber-Hansen, Rikke; Hastrup, Nina; Clemmensen, Ole; Behrendt, Nille; Klausen, Siri; Ramsing, Mette; Spaun, Eva; Hamilton-Dutoit, Stephen Jacques; Steiniche, Torben

2012-02-01

Metastasis size in melanoma sentinel lymph nodes (SLNs) is an emerging prognostic factor. Two European melanoma treatment trials include SLN metastasis diameters as inclusion criteria. Whilst diameter estimates are sensitive to the number of sections examined, the level of this bias is largely unknown. We performed a prospective multicentre study to compare the European Organisation for Research and Treatment of Cancer (EORTC) recommended protocol with a protocol of complete step-sectioning. One hundred and thirty-three consecutive SLNs from seven SLN centres were analysed by five central sections 50μm apart (EORTC Protocol) followed by complete 250μm step-sectioning. Overall, 29 patients (21.8%) were SLN-positive. The EORTC Protocol missed eight of these metastases (28%), one metastasis measuring less than 0.1mm in diameter, seven measuring between 0.1 and 1mm. Complete step-sectioning at 250μm intervals (Extensive Protocol) missed one metastasis (3%) that measured less than 0.1mm. Thirteen treatment courses (34%) performed if inclusion was based on the Combined Protocol would not be performed if assessed by the EORTC Protocol. Thus, 10 patients would be without completion lymph node dissection (EORTC MINITUB study), whilst three patients would not be eligible for anti-CTLA4 trial (EORTC protocol 18071). The corresponding number with the Extensive Protocol would be three; one patient for the MINITUB registration study and two patients for the anti-CTLA4 study. Examining SLNs by close central sectioning alone (EORTC Protocol) misses a substantial number of metastases and underestimates the maximum metastasis diameter, leading to important changes in patient eligibility for various treatment protocols. Copyright © 2011 Elsevier Ltd. All rights reserved.

Giftedness and Subjective Well-Being: A Study with Adults

ERIC Educational Resources Information Center

Wirthwein, Linda; Rost, Detlef H.

2011-01-01

Studies on the well-being of gifted adults are rare, and the available studies are often limited by methodological shortcomings. In a longitudinal project 101 intellectually gifted adults (mean IQ = 136) were compared to 91 adults of average intelligence (mean IQ = 103). Subjective well-being was operationalized by positive and negative…

Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

PubMed

Furberg, Robert D; Ortiz, Alexa M; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

2016-06-27

Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

Prayer Healing: A Case Study Research Protocol.

PubMed

Kruijthoff, Dirk J; van der Kooi, Cornelis; Glas, Gerrit; Abma, Tineke A

2017-01-01

Context • Prayer healing is a common practice in many religious communities around the world. Even in the highly secularized Dutch society, cases of prayer healing are occasionally reported in the media, often generating public attention. There is an ongoing debate regarding whether such miraculous cures do actually occur and how to interpret them. Objective • The aim of the article was to present a research protocol for the investigation of reported cases of remarkable and/or unexplained healing after prayer. Design • The research team developed a method to perform a retrospective, case-based study of prayer healing. Reported prayer healings can be investigated systematically in accordance with a step-by-step methodology. The focus is on understanding the healing by studying it from multiple perspectives, using both medical judgment and patients' narratives collected by qualitative methods Setting • The study occurred at Vrije Universiteit (VU) and VU Medical Center (Amsterdam, Netherlands) as well as the general medical practice of the first author. Participants • Potential participants could be any individuals in the Netherlands or neighboring countries who claim to have been healed through prayer. The reports of healing came from multiple sources, including the research team's medical practices and their direct vicinities, newspaper articles, prayer healers, and medical colleagues. Outcome Measures • Medical data were obtained before and after prayer. Subsequently, a member of a research team and of a medical assessment committee made a standardized judgment that evaluated whether a cure was clinically remarkable or scientifically unexplained. The participants' experiences and insider perspectives were studied, using in-depth interviews in accordance with a qualitative research methodology, to gain insight into the perceptions and explanations of the cures that were offered by participants and by the members of the medical assessment committee. The

Addressing Participant Validity in a Small Internet Health Survey (The Restore Study): Protocol and Recommendations for Survey Response Validation.

PubMed

Dewitt, James; Capistrant, Benjamin; Kohli, Nidhi; Rosser, B R Simon; Mitteldorf, Darryl; Merengwa, Enyinnaya; West, William

2018-04-24

While deduplication and cross-validation protocols have been recommended for large Web-based studies, protocols for survey response validation of smaller studies have not been published. This paper reports the challenges of survey validation inherent in a small Web-based health survey research. The subject population was North American, gay and bisexual, prostate cancer survivors, who represent an under-researched, hidden, difficult-to-recruit, minority-within-a-minority population. In 2015-2016, advertising on a large Web-based cancer survivor support network, using email and social media, yielded 478 completed surveys. Our manual deduplication and cross-validation protocol identified 289 survey submissions (289/478, 60.4%) as likely spam, most stemming from advertising on social media. The basic components of this deduplication and validation protocol are detailed. An unexpected challenge encountered was invalid survey responses evolving across the study period. This necessitated the static detection protocol be augmented with a dynamic one. Five recommendations for validation of Web-based samples, especially with smaller difficult-to-recruit populations, are detailed. ©James Dewitt, Benjamin Capistrant, Nidhi Kohli, B R Simon Rosser, Darryl Mitteldorf, Enyinnaya Merengwa, William West. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.04.2018.

Chromatin Immunoprecipitation (ChIP) Protocol for Low-abundance Embryonic Samples.

PubMed

Rehimi, Rizwan; Bartusel, Michaela; Solinas, Francesca; Altmüller, Janine; Rada-Iglesias, Alvaro

2017-08-29

Chromatin immunoprecipitation (ChIP) is a widely-used technique for mapping the localization of post-translationally modified histones, histone variants, transcription factors, or chromatin-modifying enzymes at a given locus or on a genome-wide scale. The combination of ChIP assays with next-generation sequencing (i.e., ChIP-Seq) is a powerful approach to globally uncover gene regulatory networks and to improve the functional annotation of genomes, especially of non-coding regulatory sequences. ChIP protocols normally require large amounts of cellular material, thus precluding the applicability of this method to investigating rare cell types or small tissue biopsies. In order to make the ChIP assay compatible with the amount of biological material that can typically be obtained in vivo during early vertebrate embryogenesis, we describe here a simplified ChIP protocol in which the number of steps required to complete the assay were reduced to minimize sample loss. This ChIP protocol has been successfully used to investigate different histone modifications in various embryonic chicken and adult mouse tissues using low to medium cell numbers (5 x 10 4 - 5 x 10 5 cells). Importantly, this protocol is compatible with ChIP-seq technology using standard library preparation methods, thus providing global epigenomic maps in highly relevant embryonic tissues.

LAN (Local Area Network) Interoperability Study of Protocols Needed for Distributed Command and Control

DTIC Science & Technology

1985-03-01

model referred to by the study group . IMCKIiN cuINICATION 31215FOR SDATA TWSU•l Sa *BSTtEO POOTO• AA14FTICT’WI PEM1 ITS ...operating systems, compared the DOD and ISO networking protocol architecture models , the protocols for LAN’s developed by the IEEE and ANSI, reviewed and...be initiated, so as to provide the Air Force a roadmap to guide its * "technology develop •ents. 4,’ �/LAN 3-4 .°. SECTION 4.0

Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board.

PubMed

Zia, Mohammad I; Heslegrave, Ronald; Newton, Gary E

2011-12-01

The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised.

A novel protocol for dispatcher assisted CPR improves CPR quality and motivation among rescuers-A randomized controlled simulation study.

PubMed

Rasmussen, Stinne Eika; Nebsbjerg, Mette Amalie; Krogh, Lise Qvirin; Bjørnshave, Katrine; Krogh, Kristian; Povlsen, Jonas Agerlund; Riddervold, Ingunn Skogstad; Grøfte, Thorbjørn; Kirkegaard, Hans; Løfgren, Bo

2017-01-01

Emergency dispatchers use protocols to instruct bystanders in cardiopulmonary resuscitation (CPR). Studies changing one element in the dispatcher's protocol report improved CPR quality. Whether several changes interact is unknown and the effect of combining multiple changes previously reported to improve CPR quality into one protocol remains to be investigated. We hypothesize that a novel dispatch protocol, combining multiple beneficial elements improves CPR quality compared with a standard protocol. A novel dispatch protocol was designed including wording on chest compressions, using a metronome, regular encouragements and a 10-s rest each minute. In a simulated cardiac arrest scenario, laypersons were randomized to perform single-rescuer CPR guided with the novel or the standard protocol. a composite endpoint of time to first compression, hand position, compression depth and rate and hands-off time (maximum score: 22 points). Afterwards participants answered a questionnaire evaluating the dispatcher assistance. The novel protocol (n=61) improved CPR quality score compared with the standard protocol (n=64) (mean (SD): 18.6 (1.4)) points vs. 17.5 (1.7) points, p<0.001. The novel protocol resulted in deeper chest compressions (mean (SD): 58 (12)mm vs. 52 (13)mm, p=0.02) and improved rate of correct hand position (61% vs. 36%, p=0.01) compared with the standard protocol. In both protocols hands-off time was short. The novel protocol improved motivation among rescuers compared with the standard protocol (p=0.002). Participants guided with a standard dispatch protocol performed high quality CPR. A novel bundle of care protocol improved CPR quality score and motivation among rescuers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The Importance of Trust in the Adoption and Use of Intelligent Assistive Technology by Older Adults to Support Aging in Place: Scoping Review Protocol.

PubMed

McMurray, Josephine; Strudwick, Gillian; Forchuk, Cheryl; Morse, Adam; Lachance, Jessica; Baskaran, Arani; Allison, Lauren; Booth, Richard

2017-11-02

Intelligent assistive technologies that complement and extend human abilities have proliferated in recent years. Service robots, home automation equipment, and other digital assistant devices possessing artificial intelligence are forms of assistive technologies that have become popular in society. Older adults (>55 years of age) have been identified by industry, government, and researchers as a demographic who can benefit significantly from the use of intelligent assistive technology to support various activities of daily living. The purpose of this scoping review is to summarize the literature on the importance of the concept of "trust" in the adoption of intelligent assistive technologies to assist aging in place by older adults. Using a scoping review methodology, our search strategy will examine the following databases: ACM Digital Library, Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline, PsycINFO, Scopus, and Web of Science. Two reviewers will independently screen the initial titles obtained from the search, and these results will be further inspected by other members of the research team for inclusion in the review. This review will provide insights into how the concept of trust is actualized in the adoption of intelligent assistive technology by older adults. Preliminary sensitization to the literature suggests that the concept of trust is fluid, unstable, and intimately tied to the type of intelligent assistive technology being examined. Furthermore, a wide range of theoretical lenses that include elements of trust have been used to examine this concept. This review will describe the concept of trust in the adoption of intelligent assistive technology by older adults, and will provide insights for practitioners, policy makers, and technology vendors for future practice. ©Josephine McMurray, Gillian Strudwick, Cheryl Forchuk, Adam Morse, Jessica Lachance, Arani Baskaran, Lauren

Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study.

PubMed

Saberi, Parya; Ming, Kristin; Legnitto, Dominique; Neilands, Torsten B; Gandhi, Monica; Johnson, Mallory O

2018-01-01

There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned. The 6-month pilot study aimed to examine the feasibility and acceptability of a remotely conducted study to evaluate the correlation between: 1) text-messaged photographs of pharmacy refill dates for refill-based adherence; 2) text-messaged photographs of pills for pill count-based adherence; and 3) home-collected hair sample measures of ARV concentration for pharmacologic-based adherence. Participants were sent monthly automated text messages to collect refill dates and pill counts that were taken and sent via mobile telephone photographs, and hair collection kits every 2 months by mail. At the study end, feasibility was calculated by specific metrics, such as the receipt of hair samples and responses to text messages. Participants completed a quantitative survey and qualitative exit interviews to examine the acceptability of these adherence evaluation methods. The relationship between the 3 novel metrics of adherence and self-reported adherence will be assessed. Investigators conducting adherence research are often limited to using either self-reported adherence, which is subjective, biased, and often overestimated, or other more complex methods. Here, we describe the protocol for evaluating the feasibility and acceptability of 3 novel and remote methods of estimating adherence, with the aim of evaluating the relationships between them. Additionally, we note the lessons learned from the protocol

Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study

PubMed Central

Saberi, Parya; Ming, Kristin; Legnitto, Dominique; Neilands, Torsten B; Gandhi, Monica; Johnson, Mallory O

2018-01-01

Background There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned. Methods The 6-month pilot study aimed to examine the feasibility and acceptability of a remotely conducted study to evaluate the correlation between: 1) text-messaged photographs of pharmacy refill dates for refill-based adherence; 2) text-messaged photographs of pills for pill count-based adherence; and 3) home-collected hair sample measures of ARV concentration for pharmacologic-based adherence. Participants were sent monthly automated text messages to collect refill dates and pill counts that were taken and sent via mobile telephone photographs, and hair collection kits every 2 months by mail. At the study end, feasibility was calculated by specific metrics, such as the receipt of hair samples and responses to text messages. Participants completed a quantitative survey and qualitative exit interviews to examine the acceptability of these adherence evaluation methods. The relationship between the 3 novel metrics of adherence and self-reported adherence will be assessed. Discussion Investigators conducting adherence research are often limited to using either self-reported adherence, which is subjective, biased, and often overestimated, or other more complex methods. Here, we describe the protocol for evaluating the feasibility and acceptability of 3 novel and remote methods of estimating adherence, with the aim of evaluating the relationships between them. Additionally, we note the lessons

Beyond Utterances: Distributed Cognition as a Framework for Studying Discourse in Adults with Acquired Brain Injury

PubMed Central

Duff, Melissa C.; Mutlu, Bilge; Byom, Lindsey; Turkstra, Lyn S.

2014-01-01

Considerable effort has been directed at understanding the nature of the communicative deficits observed in individuals with acquired brain injuries. Yet several theoretical, methodological, and clinical challenges remain. In this article, we examine distributed cognition as a framework for understanding interaction among communication partners, interaction of communication and cognition, and interaction with the environments and contexts of everyday language use. We review the basic principles of distributed cognition and the implications for applying this approach to the study of discourse in individuals with cognitive-communication disorders. We also review a range of protocols and findings from our research that highlight how the distributed cognition approach might offer a deeper understanding of communicative mechanisms and deficits in individuals with cognitive communication impairments. The advantages and implications of distributed cognition as a framework for studying discourse in adults with acquired brain injury are discussed. PMID:22362323

Protocol for a cluster randomised controlled trial on information technology-enabled nutrition intervention among urban adults in Chandigarh (India): SMART eating trial

PubMed Central

Kaur, Jasvir; Kaur, Manmeet; Webster, Jacqui; Kumar, Rajesh

2018-01-01

ABSTRACT Nutrition is an important determinant of health. At present, nutrition programs in India mainly emphasize improving maternal and child nutrition. Adult nutrition has not received due attention, though diseases like hypertension and diabetes are largely preventable through changes in dietary and physical activity behaviour. Little is known about the best approaches to improve dietary behaviours, especially the role of modern information technology (IT) in health education. We describe the protocol of the SMART Eating (Small, Measurable and Achievable dietary changes by Reducing fat, sugar and salt consumption and Trying different fruits and vegetables) health promotion intervention. A Cluster Randomised Controlled Trial will evaluate the effect of an IT-enabled intervention on nutrition behaviour among urban adults of Chandigarh, India. Formative research using a qualitative exploratory approach was undertaken to inform the intervention. The IT-enabled intervention programme includes website development, Short Message Service (SMS), e-mail reminders and interactive help by mobile and landline phones. The IT-enabled intervention will be compared to the traditional nutrition education program of distributing pamphlets in the control group. The primary outcome will be the percentage of study participants meeting the dietary intake guidelines of the National Institute of Nutrition, Hyderabad, India and the change in intake of fat, sugar, salt, fruit and vegetables after the intervention. The difference in differences method will be used to determine the net change in dietary intakes resulting from the interventions. Measurements will be made at baseline and at 6 months post-intervention, using a food frequency questionnaire. The formative research led to the development of a comprehensive intervention, focusing on five dietary components and using multi-channel communication approach including the use of IT to target urban North Indians from diverse socio

EVA Human Health and Performance Benchmarking Study Overview and Development of a Microgravity Protocol

NASA Technical Reports Server (NTRS)

Norcross, Jason; Jarvis, Sarah; Bekdash, Omar; Cupples, Scott; Abercromby, Andrew

2017-01-01

The primary objective of this study is to develop a protocol to reliably characterize human health and performance metrics for individuals working inside various EVA suits under realistic spaceflight conditions. Expected results and methodologies developed during this study will provide the baseline benchmarking data and protocols with which future EVA suits and suit configurations (e.g., varied pressure, mass, center of gravity [CG]) and different test subject populations (e.g., deconditioned crewmembers) may be reliably assessed and compared. Results may also be used, in conjunction with subsequent testing, to inform fitness-for-duty standards, as well as design requirements and operations concepts for future EVA suits and other exploration systems.

Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol

PubMed Central

Furberg, Robert D; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

2016-01-01

Background Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Objective Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. Methods The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care–related infections were reviewed to develop the infection control protocol to support tablet maintenance. Results This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. Conclusions These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings. PMID:27350013

Study protocol: evaluation of specialized outpatient palliative care (SOPC) in the German state of Hesse (ELSAH study) - work package II: palliative care for pediatric patients.

PubMed

Ulrich, Lisa-R; Gruber, Dania; Hach, Michaela; Boesner, Stefan; Haasenritter, Joerg; Kuss, Katrin; Seipp, Hannah; Gerlach, Ferdinand M; Erler, Antje

2018-01-05

In 2007, the European Association of Palliative Care (EAPC) provided a comprehensive set of recommendations and standards for the provision of adequate pediatric palliative care. A number of studies have shown deficits in pediatric palliative care compared to EAPC standards. In Germany, pediatric palliative care patients can be referred to specialized outpatient palliative care (SOPC) services, which are known to enhance quality of life, e.g. by avoiding hospitalization. However, current regulations for the provision of SOPC in Germany do not account for the different circumstances and needs of children and their families compared to adult palliative care patients. The "Evaluation of specialized outpatient palliative care (SOPC) in the German state of Hesse (ELSAH)" study aims to perform a needs assessment for pediatric patients (children, adolescents and young adults) receiving SOPC. This paper presents the study protocol for this assessment (work package II). The study uses a sequential mixed-methods study design with a focus on qualitative research. Data collection from professional and family caregivers and, as far as possible, pediatric patients, will involve both a written questionnaire based on European recommendations for pediatric palliative care, and semi-structured interviews. Additionally, professional caregivers will take part in focus group discussions and participatory observations. Interviews and focus groups will be tape- or video-recorded, transcribed verbatim and analyzed in accordance with the principles of grounded theory (interviews) and content analysis (focus groups). A structured field note template will be used to record notes taken during the participatory observations. Statistical Package for Social Sciences (SPSS, version 22 or higher) will be used for descriptive statistical analyses. The qualitative data analyses will be software-assisted by MAXQDA (version 12 or higher). This study will provide important information on what matters

Implementing the Free Water Protocol does not Result in Aspiration Pneumonia in Carefully Selected Patients with Dysphagia: A Systematic Review.