Liver transplant using donors after cardiac death: a single-center approach providing outcomes comparable to donation after brain death.

PubMed

Vanatta, Jason M; Dean, Amanda G; Hathaway, Donna K; Nair, Satheesh; Modanlou, Kian A; Campos, Luis; Nezakatgoo, Nosratollah; Satapathy, Sanjaya K; Eason, James D

2013-04-01

Organ donation after cardiac death remains an available resource to meet the demand for transplant. However, concern persists that outcomes associated with donation after cardiac death liver allografts are not equivalent to those obtained with organ donation after brain death. The aim of this matched case control study was to determine if outcomes of liver transplants with donation after cardiac death donors is equivalent to outcomes with donation after brain death donors by controlling for careful donor and recipient selection, surgical technique, and preservation solution. A retrospective, matched case control study of adult liver transplant recipients at the University of Tennessee/Methodist University Hospital Transplant Institute, Memphis, Tennessee was performed. Thirty-eight donation after cardiac death recipients were matched 1:2, with 76 donation after brain death recipients by recipient age, recipient laboratory Model for End Stage Liver Disease score, and donor age to form the 2 groups. A comprehensive approach that controlled for careful donor and recipient matching, surgical technique, and preservation solution was used to minimize warm ischemia time, cold ischemia time, and ischemia-reperfusion injury. Patient and graft survival rates were similar in both groups at 1 and 3 years (P = .444 and P = .295). There was no statistically significant difference in primary nonfunction, vascular complications, or biliary complications. In particular, there was no statistically significant difference in ischemic-type diffuse intrahepatic strictures (P = .107). These findings provide further evidence that excellent patient and graft survival rates expected with liver transplants using organ donation after brain death donors can be achieved with organ donation after cardiac death donors without statistically higher rates of morbidity or mortality when a comprehensive approach that controls for careful donor and recipient matching, surgical technique, and preservation solution is used.

Motivating first-time, group O blood donors to return: Rationale and design of a randomized controlled trial of a post-donation telephone interview

PubMed Central

France, Janis L.; France, Christopher R.; Carlson, Bruce W.; Kessler, Debra A.; Rebosa, Mark; Shaz, Beth H.; Madden, Katrala; Carey, Patricia M.

2015-01-01

First-time blood donors are essential to the US donor pool, providing nearly a third of all donations. Unfortunately, there are a wide variety of obstacles to repeat donation and new donors are extremely difficult to retain. Because each donor experiences a unique set of deterrents, we developed a post-donation interview based on motivational interview principles in order to flexibly address individual barriers. The primary aim of this randomized clinical trial is to examine retention of first-time, group O blood donors who are randomly assigned to receive either a telephone-delivered interview with motivational and action planning components or a standard-of-care control call approximately six weeks after their donation. Measures of donation attitude, perceived behavioral control, intention, and motivational autonomy will be measured before and after the telephone contact using online surveys, and donation attempts will be tracked for one year using blood center donor databases. We hypothesize that, compared to controls, donors who receive the telephone interview will be more likely to make a donation attempt over the following year. In addition, we will examine possible mechanisms of action of the interview using key predictors of donation behavior as described by Self Determination Theory (i.e., motivational autonomy) and the Theory of Planned Behavior (i.e., attitude, perceived behavioral control, and intention). Results of this intervention may help to support a novel strategy to enhance retention of selected blood donors in an effort to better meet the nation’s blood supply needs. PMID:26247570

Right here, right now: the impact of the blood donation context on anxiety, attitudes, subjective norms, self-efficacy, and intention to donate blood.

PubMed

Clowes, Rebekah; Masser, Barbara M

2012-07-01

While research has established the role of anticipated emotions in augmented Theory of Planned Behavior (TPB) models of donor behavior, research has yet to consider the impact of immediate emotions that may be triggered by the blood donor context on respondents' intentions to donate blood. This study explored the impact of blood donor paraphernalia on respondents' positivity toward blood donation and on the interrelationships typically observed in TPB blood donation studies. Seventy-six participants were randomly allocated to complete TPB questionnaires assessing attitudes, subjective norm, and self-efficacy along with intention to donate blood in either an affectively "hot" (blood donation paraphernalia) or a cold (control) condition. Anxiety about donating blood was also assessed. Respondents in the affectively hot condition reported significantly greater anxiety about donating blood along with less positive attitudes, weaker subjective norms, lower self-efficacy, and lower intention to donate than respondents in the cold control condition. In support of extant TPB research, correlational analyses indicated that the relationships between attitudes, self-efficacy, and intention were not impacted upon by condition. Blood donation paraphernalia induces anxiety in donors and results in diminished positivity toward donating. An awareness of what donors experience as a function of the context of blood donation may allow blood services to effectively intervene to bolster donors' positivity toward blood donation at the point where donation can take place. © 2011 American Association of Blood Banks.

Impact of a biospecimen collection seminar on willingness to donate biospecimens among Chinese Americans: results from a randomized, controlled community-based trial.

PubMed

Tong, Elisa K; Fung, Lei-Chun; Stewart, Susan L; Paterniti, Debora A; Dang, Julie H T; Chen, Moon S

2014-03-01

Biospecimen collection from diverse populations can advance cancer disparities research, but is currently underrepresented. We partnered with a community-based clinic serving Cantonese-speaking Chinese Americans to develop and revise an educational seminar on biospecimen collection. Through a randomized controlled trial (n = 395), the intervention seminar was compared with a control seminar (cancer prevention) on change in willingness to donate biospecimens. At baseline, many were willing to donate a biospecimen (saliva, urine, hair, toenails, blood, unused cancerous tissue) whether healthy or hypothetically had cancer. Also, many would donate because future generations would benefit, and few had concerns about donation. In logistic regression analyses, there was an intervention effect for willingness to donate: urine if had cancer [OR, 2.2; 95% confidence interval (CI), 1.3-3.7], toenails if healthy (OR, 2.1; 95% CI, 1.4-3.2) or had cancer (OR, 2.3; 95% CI, 2.0-2.7), hair if healthy (OR, 1.8; 95% CI, 1.3-2.5) or had cancer (OR, 2.8; 95% CI, 1.9-4.0), and unused cancerous tissue (OR, 1.8; 95% CI, 1.2-2.9). There was also an intervention effect for donating because future generations would benefit (OR, 2.0; 95% CI, 1.4-3.0), and this attitude was a strong independent predictor for willingness to donate all biospecimens, whether healthy or had cancer (OR, 2.9-4.2). Cantonese-speaking Chinese American participants of an educational seminar on biospecimen collection showed greater increases in willingness to donate biospecimens and donating for the benefit of future generations, than participants who attended a control seminar. Donating for the benefit of future generations is a theme that should be incorporated in messages that encourage biospecimen donation for Chinese Americans. ©2014 AACR.

Impact of a Biospecimen Collection Seminar on Willingness to Donate Biospecimens among Chinese Americans: Results from a Randomized, Controlled Community-Based Trial

PubMed Central

Tong, Elisa K.; Fung, Lei-Chun; Stewart, Susan L.; Paterniti, Debora A.; Dang, Julie H.T.; Chen, Moon S.

2014-01-01

Background Biospecimen collection from diverse populations can advance cancer disparities research, but is currently underrepresented. Methods We partnered with a community-based clinic serving Cantonese-speaking Chinese Americans to develop and revise an educational seminar on biospecimen collection. Through a randomized controlled trial (n = 395), the intervention seminar was compared with a control seminar (cancer prevention) on change in willingness to donate biospecimens. Results At baseline, many were willing to donate a biospecimen (saliva, urine, hair, toenails, blood, unused cancerous tissue) whether healthy or hypothetically had cancer. Also, many would donate because future generations would benefit, and few had concerns about donation. In logistic regression analyses, there was an intervention effect for willingness to donate: urine if had cancer [OR, 2.2; 95% confidence interval (CI), 1.3–3.7], toenails if healthy (OR, 2.1; 95% CI, 1.4–3.2) or had cancer (OR, 2.3; 95% CI, 2.0–2.7), hair if healthy (OR, 1.8; 95% CI, 1.3–2.5) or had cancer (OR, 2.8; 95% CI, 1.9–4.0), and unused cancerous tissue (OR, 1.8; 95% CI, 1.2–2.9). There was also an intervention effect for donating because future generations would benefit (OR, 2.0; 95% CI, 1.4–3.0), and this attitude was a strong independent predictor for willingness to donate all biospecimens, whether healthy or had cancer (OR, 2.9–4.2). Conclusion Cantonese-speaking Chinese American participants of an educational seminar on biospecimen collection showed greater increases in willingness to donate biospecimens and donating for the benefit of future generations, than participants who attended a control seminar. Impact Donating for the benefit of future generations is a theme that should be incorporated in messages that encourage biospecimen donation for Chinese Americans. PMID:24609848

Development of common metrics for donation attitude, subjective norm, perceived behavioral control, and intention for the blood donation context.

PubMed

France, Janis L; Kowalsky, Jennifer M; France, Christopher R; McGlone, Sarah T; Himawan, Lina K; Kessler, Debra A; Shaz, Beth H

2014-03-01

The Theory of Planned Behavior has been widely used in blood donation research, but the lack of uniform, psychometrically sound measures makes it difficult to draw firm conclusions or compare results across studies. Accordingly, the goal of this study was to develop such measures of donation attitude, subjective norm, perceived behavioral control, and intention. Exploratory and confirmatory factor analyses (CFAs) were conducted on survey responses collected from college students (n = 1080). The resulting scales were then administered to an independent sample of experienced donors (n = 433) for additional CFAs and to test whether the Theory of Planned Behavior model provided a good fit to the data. CFAs conducted on both samples support the use of six-item scales, with two factors each, to measure donation attitude, subjective norm, and perceived behavioral control and a single-factor three-item scale to measure donation intention. Further, structural equation modeling of these measures revealed that the Theory of Planned Behavior provided a strong fit to the data (comparative fit index, 0.976; root mean square error of approximation, 0.041; standardized root mean square residual, 0.055) and accounted for 73.7% of the variance in donation intention. The present findings confirm the applicability of the Theory of Planned Behavior to the blood donation context and more importantly provide psychometric support for the future use of four brief measures of donation attitude, subjective norm, perceived behavioral control, and intention. © 2013 American Association of Blood Banks.

Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion

PubMed Central

Henry, David A; Carless, Paul A; Moxey, Annette J; O’Connell, Dianne; Ker, Katharine; Fergusson, Dean A

2014-01-01

Background Public concerns regarding the safety of transfused blood have prompted reconsideration of the indications for the transfusion of allogeneic red cells (blood from an unrelated donor), and a range of techniques designed to minimise transfusion requirements. Objectives To examine the evidence for the efficacy of pre-operative autologous blood donation (PAD) in reducing the need for perioperative allogeneic red blood cell (RBC) transfusion. Search methods Articles were identified by searches of the electronic databases; MEDLINE (January 1950 to July 2009), EMBASE (January 1980 to Week 31, 2009), ISI Web of Science (inception to August 2009), The Cochrane Library 2009, Issue 3, and The Cochrane Injuries Group Specialised Register (searched August 7 2009). Reference lists in relevant publications were checked and authors were contacted to identify additional studies. The searches were updated in August 2009. Selection criteria Randomised controlled trials with a concurrent control group in which adult patients, scheduled for non-urgent surgery, were randomised to PAD, or to a control group who did not receive the intervention. Data collection and analysis Data were independently extracted and the risk of bias was assessed. Relative risks (RR) and mean differences (MD) with 95% confidence intervals (CIs) were calculated. Data were pooled using a random-effects model. The principal outcomes were the proportion of patients exposed to allogeneic red blood cells (RBCs) and the amount of blood transfused. Other clinical outcomes are detailed in the review. Main results Fourteen trials were included. Overall PAD reduced the risk of receiving an allogeneic blood transfusion by a relative 68% (RR 0.32; 95% CI 0.22 to 0.47). The absolute reduction in risk of allogeneic transfusion was 44% (risk difference (RD) −0.44; 95% CI −0.68 to −0.21). In contrast, the results show that the risk of receiving any blood transfusion (allogeneic and/or autologous) is increased by PAD (RR 1.24; 95% CI 1.02 to 1.51). There was evidence of significant heterogeneity for both of these outcomes. Authors’ conclusions Although the trials of PAD showed a reduction in the need for allogeneic blood, the methodological quality of the trials was poor and the overall transfusion rates (allogeneic and/or autologous) in these trials were high, and were increased by recruitment into the PAD arms of the trials. This raises questions about the true benefit of PAD. In the absence of large, high quality trials using clinical endpoints, it is not possible to say whether the benefits of PAD outweigh the harms. PMID:12076491

Changes in pre- and post-donation platelet function in plateletpheresis donors.

PubMed

Zhou, Q; Yu, X; Cai, Y; Liu, L

2017-11-01

This study aimed to investigate the changes of platelet (PLT) function and coagulation time before and after plateletpheresis donation. The healthy donors were divided into four groups according to the annual number of plateletpheresis donation: 20 times group, 15 times group, 10 times group and 5 times group. The healthy non-blood donors were selected as controls. The donation interval was 14 days. The blood samples were collected before plateletpheresis donation and after 30min, 7 d, and 14 d of donation for determination of coagulation time, PLT function, plasma protein, serum iron and blood routine change. After 30min of plateletpheresis donation, the PLT function decreased and the coagulation time was prolonged. However, PLT function recovered to the pre-collection after 7 d of plateletpheresis donation and coagulation time recovered to the pre-collection after 14 d of plateletpheresis donation. Additionally, there was no difference regarding blood coagulation time and PLT function among blood donors and controls. The plasma protein and serum iron levels in 20 times and 15 times groups were within the normal reference range. The frequency of plateletpheresis donation will not affect PLT function, coagulation time, plasma protein and serum iron in donors. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

An Adapted Post-Donation Motivational Interview Enhances Blood Donor Retention

PubMed Central

Sinclair, Kadian S.; Campbell, Tavis S.; Carey, Patricia M.; Langevin, Eric; Bowser, Brent; France, Christopher R.

2010-01-01

Background Blood donors may hold conflicting thoughts about future donation. While they may perceive the direct benefit to themselves and others, they often report compelling reasons not to give again. As a result the standard encouragements to return may not be sufficient to motivate some donors. The present study examined the effects of a post-donation adapted motivational interview on blood donor attitudes and repeat donation behavior. Study Design and Methods Donors (n=215) were randomly assigned to either an adapted motivational interview (AMI) or a no-interview control group. Approximately one month after their index donation, donors in the AMI group completed a brief telephone interview to clarify individual-specific motivations and values concerning blood donation and address potential barriers. They were then asked to complete questionnaires regarding donation attitudes, anxiety, self-efficacy and intention to donate. Donors in the control group were also contacted one month post-donation and asked to complete the same series of questionnaires. Results Donors in the AMI group reported greater intention to provide a future donation, F = 8.13, p < 0.05, more positive donation attitudes, F = 4.59, p < 0.05, and greater confidence in their ability to avoid adverse reactions, F = 10.26, p < 0.01. Further, AMI was associated with higher rates of attempted donation at 12 months (OR, 2.48; 95% CI, 1.27–4.87). Conclusion Application of an adapted motivational interview may be an effective strategy to increase the donor pool by enhancing retention of existing donors. PMID:20456674

The OPTIMIST study: optimisation of cost effectiveness through individualised FSH stimulation dosages for IVF treatment. A randomised controlled trial

PubMed Central

2012-01-01

Background Costs of in vitro fertilisation (IVF) are high, which is partly due to the use of follicle stimulating hormone (FSH). FSH is usually administered in a standard dose. However, due to differences in ovarian reserve between women, ovarian response also differs with potential negative consequences on pregnancy rates. A Markov decision-analytic model showed that FSH dose individualisation according to ovarian reserve is likely to be cost-effective in women who are eligible for IVF. However, this has never been confirmed in a large randomised controlled trial (RCT). The aim of the present study is to assess whether an individualised FSH dose regime based on an ovarian reserve test (ORT) is more cost-effective than a standard dose regime. Methods/Design Multicentre RCT in subfertile women indicated for a first IVF or intracytoplasmic sperm injection cycle, who are aged < 44 years, have a regular menstrual cycle and no major abnormalities at transvaginal sonography. Women with polycystic ovary syndrome, endocrine or metabolic abnormalities and women undergoing IVF with oocyte donation, will not be included. Ovarian reserve will be assessed by measuring the antral follicle count. Women with a predicted poor response or hyperresponse will be randomised for a standard versus an individualised FSH regime (150 IU/day, 225-450 IU/day and 100 IU/day, respectively). Participants will undergo a maximum of three stimulation cycles during maximally 18 months. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months after randomisation. Secondary outcomes are parameters for ovarian response, multiple pregnancies, number of cycles needed per live birth, total IU of FSH per stimulation cycle, and costs. All data will be analysed according to the intention-to-treat principle. Cost-effectiveness analysis will be performed to assess whether the health and associated economic benefits of individualised treatment of subfertile women outweigh the additional costs of an ORT. Discussion The results of this study will be integrated into a decision model that compares cost-effectiveness of the three dose-adjustment strategies to a standard dose strategy. The study outcomes will provide scientific foundation for national and international guidelines. Trial registration NTR2657 PMID:22989359

Influence of Children's Positive Self-Perceptions on Donating Behavior in a Naturalistic Setting.

ERIC Educational Resources Information Center

Holte, Carol S.; And Others

1984-01-01

Investigated the effects of self-perceptions on the donating behavior of 43 fourth-grade students who had two opportunities to donate gum to another class. Students who received feedback after the first donation period indicating that they were particularly generous subsequently gave more than children in the control group. (JAC)

75 FR 23265 - Submission for OMB Review; Comment Request; Investigating the Causes of Post Donation Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-03

... displays a current valid OMB control number. Proposed Collection: Title: Investigating the causes of post...; Comment Request; Investigating the Causes of Post Donation Information (PDI): Errors in the Donor... Post Donation Information (PDI). While this deferral risk may be at the next donation event, many...

[Liver transplant with donated graft after controlled cardiac death. Current situation].

PubMed

Abradelo De Usera, Manuel; Jiménez Romero, Carlos; Loinaz Segurola, Carmelo; Moreno González, Enrique

2013-11-01

An increasing pressure on the liver transplant waiting list, forces us to explore new sources, in order to expand the donor pool. One of the most interesting and with a promising potential, is donation after cardiac death (DCD). Initially, this activity has developed in Spain by means of the Maastricht type II donation in the uncontrolled setting. For different reasons, donation after controlled cardiac death has been reconsidered in our country. The most outstanding circumstance involved in DCD donation is a potential ischemic stress, that could cause severe liver graft cell damage, resulting in an adverse effect on liver transplant results, in terms of complications and outcomes. The complex and particular issues related to DCD Donation will be discussed in this review. Copyright © 2012 AEC. Published by Elsevier Espana. All rights reserved.

Does quality improvement work? Evaluation of the Organ Donation Breakthrough Collaborative.

PubMed

Howard, David H; Siminoff, Laura A; McBride, Virginia; Lin, Monica

2007-12-01

The Organ Donation Breakthrough Collaborative is a quality improvement initiative to encourage adoption of "best practices" for identifying potential donors and obtaining consent for deceased organ donation. We evaluate the impact of the first phase on organ donation rates. We study donation rates in the 95 hospitals that participated in the first phase and a control group of 125 hospitals. We use a controlled pre/post design. The preperiod is the year before the start of the Collaborative (September 2002 to August 2003), the postperiod is the final 6 months of the first phase (March 2004 to August 2004). We use administrative data from the Organ Procurement and Transplantation Network to compute the conversion rate in each hospital group and time period. The conversion rate is the proportion of eligible donors who became actual donors. Preperiod conversion rates in Collaborative and control hospitals were similar: 52 and 51 percent, respectively. In the postperiod, the conversion rate increased to 60 percent among Collaborative hospitals and remained at 51 percent among control hospitals. The relative change was 8 percentage points (95 percent confidence interval: 2-13: p<.001). Our findings suggest that the Breakthrough Collaborative led to an increase in donation rates at participating hospitals.

A comparison of the effects of oral vs. intravenous hydration on subclinical acute kidney injury in living kidney donors: a protocol of a randomised controlled trial.

PubMed

Mackinnon, Shona; Aitken, Emma; Ghita, Ryan; Clancy, Marc

2017-01-19

Optimal treatment for established renal failure is living donor kidney transplantation. However this pathway exposes healthy individuals to significant reduction in nephron mass via major surgical procedure. Laparoscopic donor nephrectomy is now the most common method for live donor transplantation, reducing both donor post-operative pain and recovery time. However this procedure exposes kidneys to additional haemodynamic stresses. It has been suggested that donor hydration-particularly the use of preoperative intravenous fluids-may counteract these stresses, reducing subclinical acute kidney injury and ultimately improving long-term renal function. This may be important in both preservation of donor renal function and recipient graft longevity. A prospective single-centre single-blinded randomized controlled trial will be carried out to determine the effects of donor preoperative intravenous fluids. The primary outcome is donor subclinical acute kidney injury (defined as plasma NGAL, >153 ng/ml) on day 1 postoperatively. Secondary outcomes include intraoperative haemodynamics, recipient subclinical acute kidney injury, perioperative complications and donor sleep quality. Donors will be randomised into two groups: the intervention group will receive active pre-hydration consisting of three litres of intravenous Hartmann's solution between midnight and 8 am before morning kidney donation, while the control group will not receive this. Both groups will receive unlimited oral fluids until midnight, as is routine. Plasma NGAL will be measured at pre-specified perioperative time points, intraoperative haemodynamic data will be collected using non-invasive cardiac output monitoring and clinical notes will be used to obtain demographic and clinical data. The researcher will be blinded to the donor fluid hydration status. Blinded statistical analysis will be performed on an intention-to-treat basis. A prospective power calculation estimates a required sample size of 86 patients. This study will provide important data, as there is currently little evidence about the use of donor preoperative fluids in laparoscopic nephrectomy. It is hoped that the results obtained will guide future clinical practice. This study has been approved by the West of Scotland Research Ethics Committee 3 (reference no. 14/WS/1160, 27 January 2015) and is registered with the International Standard Randomised Controlled Trial Number Register (reference no. ISRCTN10199225 , 20 April 2015).

Enhancing blood donation intentions using multimedia donor education materials.

PubMed

France, Christopher R; France, Janis L; Wissel, Mary Ellen; Kowalsky, Jennifer M; Bolinger, Elizabeth M; Huckins, Jamie L

2011-08-01

Prior research has shown that education materials that directly address prospective donor concerns and provide specific coping suggestions are particularly effective at enhancing donation attitudes and intentions to give blood. This study compared the effect of donor coping materials, provided in written and audiovisual formats, as potential tools to enhance recruitment of prospective blood donors. The role of initial attitudes toward blood donation on responses to these materials was also considered. Young adults (62% female; mean [SD] age=19.1 [1.4]; mean [range] prior blood donations=1.32 [0-13]) were randomly assigned to 1) read a brochure addressing common blood donor concerns and suggesting specific coping strategies, 2) view a video addressing blood donor concerns and illustrating coping techniques, 3) read the brochure and view the video, or 4) read a control brochure on healthy eating and exercise. Measures of blood donation attitudes, anxiety, confidence, and intentions to give blood were completed before and after the intervention. Relative to the control brochure, all the intervention groups showed larger reductions in anxiety, more positive changes in attitude, and greater increases in donation confidence and intentions. The combination of the brochure and video outperformed either intervention alone in further improving donation attitudes among participants with high initial donation attitudes. Blood donation coping materials, presented in either written or audiovisual formats, significantly enhance willingness to donate blood among young adults regardless of their initial attitudes toward blood donation. © 2011 American Association of Blood Banks.

Beyond providing drugs: the Mectizan® donation stimulates new strategies in service delivery and in strengthening health systems.

PubMed

Hopkins, Adrian

2012-05-01

The donation of Mectizan® by Merck & Co Inc. in 1987 "as much as was needed for as long as was needed for onchocerciasis control" was a major change from traditional corporate drug donations. The company realised that those who needed the drug most would never be able to purchase it, and so gave it away. The donation enabled the Onchocerciasis Control Programme in West Africa to add Mectizan distribution to its ongoing control strategy. For the first time there was hope for those living in other areas of Africa, Latin America and Yemen. Governments and non-governmental development organizations quickly got together to begin treatment in these new areas. Two new programmes and partnerships were created; the African Programme for Onchocerciasis Control and the Onchocerciasis Elimination Programme for the Americas. These programmes have been in the forefront of developing new strategies, including the Community Directed approach, which has now expanded into other disease control programmes at the community level, such as Vitamin A distribution and malaria control. This donation has led not only to the probability of elimination of onchocerciasis in the Americas in the near future, but is stimulating approaches to the elimination in Africa, in areas considered impossible five years ago. Other major pharmaceutical donations have followed, initiating the plan to eliminate lymphatic filariasis worldwide, and also stimulating interest in controlling other "neglected tropical diseases," which affect the poorest billion of the world's population, making this now a reality.

Blood-Based Biomarkers of Early-Onset Breast Cancer

DTIC Science & Technology

2015-10-01

n=51). The women with early-onset breast cancer were disease and treatment free for at least 6 months at time of blood donation . Cases and controls...were age matched to age at blood donation . 2. KEYWORDS: biomarkers, early-onset breast cancer, expression profiling, risk-assessment, breast cancer...matched controls. This prospectively collected cohort consists of blood donated to blood banks ~15 years ago and subsequently linked to the California

[Structural Equation Modeling on Living and Brain Death Organ Donation Intention in Nursing Students].

PubMed

Kim, Eun A; Choi, So Eun

2015-12-01

The purpose of this study was to test and validate a model to predict living and brain death organ donation intention in nursing students. The conceptual model was based on the theory planned behavior. Quota sampling methodology was used to recruit 921 nursing students from all over the country and data collection was done from October 1 to December 20, 2013. The model fit indices for the hypothetical model were suitable for the recommended level. Knowledge, attitude, subjective norm and perceived behavioral control explained 40.2% and 40.1% respectively for both living and brain death organ donation intention. Subjective norm was the most direct influential factor for organ donation intention. Knowledge had significant direct effect on attitude and indirect effect on subjective norm and perceived behavioral control. These effects were higher in brain death organ donation intention than in living donation intention. The overall findings of this study suggest the need to develop systematic education programs to increases knowledge about brain death organ donation. The development, application, and evaluation of intervention programs are required to improve subjective norm.

Reduced social preferences in autism: evidence from charitable donations

PubMed Central

2012-01-01

Background People with autism have abnormal preferences, ranging from an apparent lack of preference for social stimuli to unusually strong preferences for restricted sets of highly idiosyncratic stimuli. Yet the profile of preferences across social and nonsocial domains has not been mapped out in detail, and the processes responsible remain poorly understood. Methods To assess preferences across a range of stimuli, we measured real monetary donations to 50 charities spanning categories pertaining to people, mental health, animals, or the environment. We compared the donations made by 16 high-functioning adults with autism to those made by neurotypical controls matched on age, gender and education. We additionally collected ratings of how people evaluated the different charities. Results Compared with controls, high-functioning adults with autism donated less overall and also showed a significantly disproportionate reduction in donations to people charities compared with donations to the other charities. Furthermore, whereas controls discriminated strongly between different people charities, choosing to donate a lot of money to some and very little to others, much less discrimination was seen in the autism group. Ratings that probed how participants constructed their preferences did not differ between groups, except for a difference in the perceived impact of pictures and text information about people charities. Strikingly, there were some charities related to mental health, and autism in particular, to which the autism group donated considerably more than did the controls. Conclusions People with autism were found to have reduced preference and sensitivity towards charities benefiting other people. The findings provide evidence for a domain-specific impairment in social cognition in autism spectrum disorder, and in particular in linking otherwise intact social knowledge to the construction of value signals on which preferences regarding other people are based. PMID:22958506

Reduced social preferences in autism: evidence from charitable donations.

PubMed

Lin, Alice; Tsai, Karin; Rangel, Antonio; Adolphs, Ralph

2012-05-17

People with autism have abnormal preferences, ranging from an apparent lack of preference for social stimuli to unusually strong preferences for restricted sets of highly idiosyncratic stimuli. Yet the profile of preferences across social and nonsocial domains has not been mapped out in detail, and the processes responsible remain poorly understood. To assess preferences across a range of stimuli, we measured real monetary donations to 50 charities spanning categories pertaining to people, mental health, animals, or the environment. We compared the donations made by 16 high-functioning adults with autism to those made by neurotypical controls matched on age, gender and education. We additionally collected ratings of how people evaluated the different charities. Compared with controls, high-functioning adults with autism donated less overall and also showed a significantly disproportionate reduction in donations to people charities compared with donations to the other charities. Furthermore, whereas controls discriminated strongly between different people charities, choosing to donate a lot of money to some and very little to others, much less discrimination was seen in the autism group. Ratings that probed how participants constructed their preferences did not differ between groups, except for a difference in the perceived impact of pictures and text information about people charities. Strikingly, there were some charities related to mental health, and autism in particular, to which the autism group donated considerably more than did the controls. People with autism were found to have reduced preference and sensitivity towards charities benefiting other people. The findings provide evidence for a domain-specific impairment in social cognition in autism spectrum disorder, and in particular in linking otherwise intact social knowledge to the construction of value signals on which preferences regarding other people are based.

Immediate effects of blood donation on physical and cognitive performance-A randomized controlled double-blinded trial.

PubMed

Eliassen, Håkon S; Hervig, Tor; Backlund, Sebastian; Sivertsen, Joar; Iversen, Vegard Vereide; Kristoffersen, Morten; Wengaard, Eivind; Gramstad, Arne; Fosse, Theodor; Bjerkvig, Christopher K; Apelseth, Torunn; Doughty, Heidi; Strandenes, Geir

2018-06-01

The success of implementing damage control resuscitation principles pre-hospital has been at the expense of several logistic burdens including the requirements for resupply, and the question of donor safety during the development of whole blood programs. Previous studies have reported effects on physical performance after blood donation; however, none have investigated the effects of blood donation on cognitive performance. We describe a prospective double-blinded, randomized, controlled study comprised of a battery of tests: three cognitive tests, and VO2max testing on a cycle ergometer. Testing was performed 7 days before blinded donation (baseline day), immediately after donation (Day 0), and 7 days (Day 7) after donation. The inclusion criteria included being active blood donors at the Haukeland University Hospital blood bank, where eligibility requirements were met on the testing days, and providing informed consent. Participants were randomized to either the experimental (n = 26) or control group (n = 31). Control group participants underwent a 'mock donation" in which a phlebotomy needle was placed but blood was not withdrawn. In the experimental group, mean ± SEM VO2max declined 6% from 41.35 ± 1.7 mLO2/(min·kg) at baseline to 39.0 ± 1.6 mLO2/(min·kg) on Day 0 and increased to 40.51 ± 1.5 mLO2/(min·kg) on Day 7. Comparable values in the control group were 42.1 ± 1.8 mLO2/(min·kg) at baseline, 41.6 ± 1.8 mLO2/(min·kg)) on Day 1 (1% decline from baseline), and 41.8 ± 1.8 mLO2/(min·kg) on Day 7.Comparing scores of all three cognitive tests on Day 0 and Day 7 showed no significant differences (p > 0.05). Our main findings are that executive cognitive and physical performances were well maintained after whole blood donation in healthy blood donors. The findings inform postdonation guidance on when donors may be required to return to duty. Randomized, controlled, double-blinded prospective trial study, level 1.

75 FR 29507 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-26

... of Commodities for Foreign Donation. OMB Control Number: 0560-0258. Summary of Collection: 7 CFR part 1496, Procurement of Processed Agricultural Commodities for Donation under Title II, Public Law 480 is... Credit Corporation (CCC) for donation overseas under various food aid authorities. The information...

Ethical, legal, and societal issues and recommendations for controlled and uncontrolled DCD.

PubMed

Haase, Bernadette; Bos, Michael; Boffa, Catherine; Lewis, Penney; Rudge, Chris; Valero, Ricard; Wind, Tineke; Wright, Linda

2016-07-01

This report deals with organ retrieval procedures in both controlled and uncontrolled DCD, looking at the ethical, legal, and psychosocial aspects during the different phases of the process. A recently published report by the UK Donation Ethics Committee (UKDEC) has served as an important reference document to outline the steps in the controlled DCD patient-donor pathway (Academy of Medical Royal Colleges. UK Donation Ethics Committee. An ethical framework for controlled donation after circulatory death. December 2011). For uncontrolled DCD, the UKDEC pathway description was adapted. At the 6th International Conference in Organ Donation held in Paris in 2013, an established expert European Working Group reviewed the UKDEC reports, which were then considered along with the available published literature. Along this pathway, the crucial ethical, legal, and psychosocial aspects have been flagged, and relevant recommendations have been formulated based on a consensus of the working group. © 2015 Steunstichting ESOT.

Social support attenuates presyncopal reactions to blood donation.

PubMed

Hanson, Sarah A; France, Christopher R

2009-05-01

The experience of unpleasant blood donation reactions (e.g., dizziness, nausea, and fainting) has been linked to negative attitudes about donation and decreased likelihood of repeat donation. Consequently, interventions to reduce the adverse effects of blood donation are important and likely to increase donor retention. Based on laboratory studies suggesting that social support attenuates both physical and psychological responses to stress, the present study hypothesized that the presence of a supportive person during the donation process may help reduce reactions. A final sample of 65 men and women with fewer than three prior donations was randomly assigned to either donate blood as usual or donate with a supportive research assistant. Donors in the support condition were accompanied throughout the donation process by a female research assistant who provided encouragement, made reassuring remarks, and engaged in small talk. Donors in both conditions completed a series of questions to assess anxiety, experience of prefaint reactions, and willingness to provide a future donation. Compared to standard donation controls, donors in the social support condition reported fewer prefaint reactions (F(1,61) = 9.15, p = 0.004, eta(2)= 0.13) and greater likelihood of donating again within the next year (Z =-1.70, p < 0.05, one-tailed). Relatively novice donors report reduced reactions to blood donation when accompanied by a supportive individual, suggesting that social support may be a simple strategy to enhance the donation experience and possibly increase donor retention.

Anatomists' views on human body dissection and donation: an international survey.

PubMed

Arráez-Aybar, Luis-Alfonso; Bueno-López, José Luis; Moxham, Bernard John

2014-12-01

A survey was conducted to test three hypotheses: anatomists believe that dissection by students conveys not just anatomical knowledge but also essential skills and attitudes, including professionalism; anatomists approve of the donation of their own bodies or body parts/organs for medical/health-care training and research; attitudes towards body dissection and donation are not dependent upon gender or upon the extent of teaching experience, but are related to transcendental convictions relating to beliefs in the afterlife. Eighty-one anatomists, from 29 countries responded to the survey; 80% indicated that they required medical/health-care students to dissect human cadavers (60% females-86% males, p=0.02). Most teachers recorded that dissection was an instrument for training undergraduate students, an instrument for the development of professional skills, and an instrument to help to control emotions in the future doctor rather than being only a means of teaching/learning anatomy facts. Males were more receptive to the concept that dissection helps to control emotions in the future doctor (p=0.02). Most teachers (75%) said they were willing to donate their bodies, 41% saying they would donate body organs only, 9% would donate their entire bodies only, 25% would separately donate organs and also the entire body. The willingness to donate increased significantly with the years of teaching experience (p=0.04). Teachers who were not believers in the afterlife were more likely to donate their organs/bodies than were believers (p=0.03). Our findings showed that anatomists' attitudes towards body dissection and donation are dependent upon gender, upon the extent of teaching experience, and upon transcendental convictions.

Stress and blood donation: effects of music and previous donation experience.

PubMed

Ferguson, E; Singh, A P; Cunningham-Snell, N

1997-05-01

Making a blood donation, especially for first-time donors, can be a stressful experience. These feelings of stress may inhibit donors from returning. This paper applies stress theory to this particular problem. The effects of a stress management intervention (the provision of music) and previous donor experience were examined in relation to pre- and post-donation mood, environmental appraisals and coping behaviour. Results indicated that the provision of music had detrimental effects on environmental appraisals for those who have donated up to two times previously, but beneficial effects for those who had donated three times before. These effects were, to an extent, moderated by coping processes but not perceived control. It is recommended that the provision of music is not used as a stress management technique in the context of blood donation.

Impact of a National Controlled Donation After Circulatory Death (DCD) Program on Organ Donation in the United Kingdom: A 10-Year Study.

PubMed

Hodgson, R; Young, A L; Attia, M A; Lodge, J P A

2017-12-01

Organ transplantation is the most successful treatment for some forms of organ failure, yet a lack of organs means many die on the waiting list. In the United Kingdom, the Organ Donation Taskforce was set up to identify barriers to organ donation and in 2008 released its first report (Organ Donation Taskforce Report; ODTR). This study assesses the success since the ODTR and examines the impact of the United Kingdom's controlled donation after circulatory death (DCD) program and the controversies surrounding it. There were 12 864 intended donation after brain death (DBD) or DCD donors from April 2004 to March 2014. When the 5 years preceding the ODTR was compared to the 5 years following, intended DCD donors increased 292% (1187 to 4652), and intended DBD donors increased 11% (3327 to 3698). Organs retrieved per intended DBD donor remained static (3.30 to 3.26), whereas there was a decrease in DCD (1.54 to 0.99) due to a large rise in donors who did not proceed to donation (325 to 2464). The majority of DCD donors who proceeded did so within 30 min from time of withdrawal. Our study suggests further work on converting eligible referrals to organ donation and exploring methods of converting DCD to DBD donors. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

Applying self-determination theory to the blood donation context: The blood donor competence, autonomy, and relatedness enhancement (Blood Donor CARE) trial.

PubMed

France, Christopher R; France, Janis L; Carlson, Bruce W; Frye, Victoria; Duffy, Louisa; Kessler, Debra A; Rebosa, Mark; Shaz, Beth H

2017-02-01

The Blood Donor Competency, Autonomy, and Relatedness Enhancement (Blood Donor CARE) project was designed as a practical application of self-determination theory to encourage retention of first-time donors. Self-determination theory proposes that people are more likely to persist with behaviors that are internally-motivated, and that externally-motivated behavior can evolve and become internalized given the appropriate socio-environmental conditions. According to self-determination theory, motivation to engage in blood donation may become increasingly self-determined if the behavior satisfies fundamental human needs for competence (a sense of self-efficacy to achieve specific goals), autonomy (a sense of volitional control over one's behavior), and relatedness (a sense of connection to a larger group). The primary aim of this randomized controlled trial is to examine the effect of competence, autonomy, and/or relatedness interventions on donor retention. Using a full factorial design, first-time donors will be assigned to a control condition or one of seven intervention conditions. Donation competence, autonomy, and relatedness, along with additional constructs associated with return donation, will be assessed before and after the intervention using online surveys, and donation attempts will be tracked for one-year using blood center donor databases. We hypothesize that, compared to the control condition, the interventions will increase the likelihood of a subsequent donation attempt. We will also examine intervention-specific increases in competence, autonomy, and relatedness as potential mediators of enhanced donor retention. By promoting first-time donor competence, autonomy, and relatedness our goal is to enhance internal motivation for giving and in so doing increase the likelihood of future donation. Copyright © 2016 Elsevier Inc. All rights reserved.

Applying self-determination theory to the blood donation context: The blood donor competence, autonomy, and relatedness enhancement (Blood Donor CARE) trial

PubMed Central

France, Christopher R.; France, Janis L.; Carlson, Bruce W.; Frye, Victoria; Duffy, Louisa; Kessler, Debra A.; Rebosa, Mark; Shaz, Beth H.

2016-01-01

The Blood Donor Competency, Autonomy, and Relatedness Enhancement (Blood Donor CARE) project was designed as a practical application of self-determination theory to encourage retention of first-time donors. Self-determination theory proposes that people are more likely to persist with behaviors that are internally-motivated, and that externally-motivated behavior can evolve and become internalized given the appropriate socio-environmental conditions. According to self-determination theory, motivation to engage in blood donation may become increasingly self-determined if the behavior satisfies fundamental human needs for competence (a sense of self-efficacy to achieve specific goals), autonomy (a sense of volitional control over one’s behavior), and relatedness (a sense of connection to a larger group). The primary aim of this randomized controlled trial is to examine the effect of competence, autonomy, and/or relatedness interventions on donor retention. Using a full factorial design, first-time donors will be assigned to a control condition or one of seven intervention conditions. Donation competence, autonomy, and relatedness, along with additional constructs associated with return donation, will be assessed before and after the intervention using online surveys, and donation attempts will be tracked for one-year using blood center donor databases. We hypothesize that, compared to the control condition, the interventions will increase the likelihood of a subsequent donation attempt. We will also examine intervention-specific increases in competence, autonomy, and relatedness as potential mediators of enhanced donor retention. By promoting first-time donor competence, autonomy, and relatedness our goal is to enhance internal motivation for giving and in so doing increase the likelihood of future donation. PMID:27979752

Does Donating Blood for the First Time During a National Emergency Create a Better Commitment to Donating Again?

PubMed Central

Tran, Sheri; Lewalski, Eva A.; Dwyre, Denis M.; Hagar, Yolanda; Beckett, Laurel; Janatpour, Kim A.; Holland, Paul V.

2009-01-01

Background and Objectives Emergency situations often elicit a generous response from the public. This occurred after attacks on the US on September 11, 2001 when many new blood donors lined up to donate. This study was performed to compare return rates for first time donors (FTD) after September 11th, 2001 to FTD during a comparable period in 2000. Materials and Methods 3315 allogeneic whole blood donations from FTD at a regional blood center were collected between September 11th and 30th, 2001. Subsequent donations by the FTD before March 31, 2002 were reviewed. This (test) group was compared to 1279 FTD(control group) donating during the same time period in September 2000 and to their return rate in the subsequent six months. Results Following September 11, 2001, 1087/3315 (32.8%) FTD returned by March 31, 2002. This return rate was similar to the control group (427/1279 (33.4%)). The deferral rate during the donor screening process for the control group was significantly higher than the deferral rate for the September 11–30, 2001 group (p < 0.01). The odds of an individual FTD returning increased with age, and the chance of a female donor returning was 1.13 times higher than a male (p = 0.06). There was a carryover effect after Sept. 11, 2001 too. Conclusion A national emergency, September 11, 2001, inspired people to donate blood for the first time. However, the proportion of return donations amongst them was not increased. Females and males in certain age groups were more likely to become repeat donors due to the residual effect of September 11, 2001. Additional efforts are needed to retain eligible FTD in donor pools. PMID:20002621

Defining Dogma: Quantifying Crystalloid Hemodilution in a Prospective Randomized Control Trial with Blood Donation as a Model for Hemorrhage.

PubMed

Ross, Samuel Wade; Christmas, A Britton; Fischer, Peter E; Holway, Haley; Seymour, Rachel; Huntington, Ciara R; Heniford, B Todd; Sing, Ronald F

2018-06-04

The concept of hemodilution after blood loss and crystalloid infusion is a surgical maxim that remains unproven in humans. We sought to quantify the effect of hemodilution after crystalloid administration in voluntary blood donors as a model for acute hemorrhage. A prospective, randomized control trial was conducted in conjunction with community blood drives. Donors were randomized to receive no IV fluid(noIVF), two liters normal saline(NS), or two liters lactated ringers(LR) after blood donation. Blood samples were taken before donation of 500 mL of blood, immediately after donation, and following IV fluid administration. Hemoglobin(Hgb) was measured at each time point. Hgb between time points were compared between groups using standard statistical tests and the Bonferroni correction for multiple comparisons. Statistical significance was set at p≤0.0167. Of 165 patients consented, 157 patients completed the study. Average pre-donation Hgb was 14.3 g/dL. There was no difference in the mean Hgb levels after blood donation between the three groups(p>0.05). Compared to the control group, there was a significant drop in Hgb in the crystalloid infused groups from the post-donation level to post-resuscitation(13.2 vs 12.1 vs 12.2 g/dL, p<0.0001). A formula was created to predict hemoglobin levels from a given estimated blood loss(EBL) and volume replacement(VR): Hemodilution Hgb=(MeanPre-donation Hgb - hemorrhage Hgb drop - equilibration hemoglobin drop - resuscitation Hgb drop)=MeanPre-donation Hgb - [(EBL/TBV)*l] - [(EBL/TBV)*h] - [(VR/TBV)*r], l = 5.111g/dL = blood loss coefficient, h=6.722 g/dL=equilibration coefficient, r= 2.617g/dL= resuscitation coefficient. This study proves the concept of hemodilution and derived a mathematical relationship between blood loss and resuscitation. This data may help to estimate response of hemoglobin levels to blood loss and fluid resuscitation in clinical practice. Copyright © 2018. Published by Elsevier Inc.

Memories of past episodes shape current intentions and decisions.

PubMed

Kuwabara, Kie J; Pillemer, David B

2010-05-01

This research tested the hypothesis that people's decisions and future plans are influenced by recently activated autobiographical memories. University students rated the overall quality of their college experiences. They were also asked to describe a specific memory of being either satisfied or dissatisfied with the university. Control participants did not describe a memory. After statistically controlling for pre-existing attitudes towards the university, students who recounted a positive memory expressed the strongest intentions to donate money to the university, attend a class reunion, and recommend the university to others, and they were more likely than controls to specify that an actual donation be made to the university rather than to another charity. Emotional intensity of positive memories predicted future plans and donation decisions. Students who recounted a negative memory also tended to favour the university in their actual donation decisions compared to controls. Prompting the recall of emotional memories may be an effective way to influence intentions and decisions.

A mass mediated intervention on Hispanic live kidney donation.

PubMed

Alvaro, Eusebio M; Siegel, Jason T; Crano, William D; Dominick, Alexander

2010-06-01

This research examines the impact of a Spanish language mass media campaign on living organ donation attitudes and behavioral intentions among Spanish dominant Hispanics in Tucson, Arizona. Impact was assessed via a pretest/posttest control group quasiexperimental design with Tucson, Arizona, as the intervention community and Phoenix, Arizona, as the control. Preintervention focus groups provided qualitative data to guide intervention development, while telephone surveys in both communities provided quantitative data to assess campaign impact. Analyses reveal pretest/posttest differences in the intervention community such that posttest intentions regarding living organ donation behaviors increased from pretest. No such differences were observed in the control community. Subsequent analyses revealed differences between respondents in the intervention community exposed to the campaign vs. those in the same community not exposed to the campaign. Exposed respondents reported more positive living organ donation behavioral intentions than nonexposed respondents. Implications for research and practice are discussed.

Randomised trial of educational visits to enhance use of systematic reviews in 25 obstetric units

PubMed Central

Wyatt, Jeremy C; Paterson-Brown, Sarah; Johanson, Richard; Altman, Douglas G; Bradburn, Michael J; Fisk, Nicholas M

1998-01-01

Objective To evaluate the effectiveness of an educational visit to help obstetricians and midwives select and use evidence from a Cochrane database containing 600 systematic reviews. Design Randomised single blind controlled trial with obstetric units allocated to an educational visit or control group. Setting 25 of the 26 district general obstetric units in two former NHS regions. Subjects The senior obstetrician and midwife from each intervention unit participated in educational visits. Clinical practices of all staff were assessed in 4508 pregnancies. Intervention Single informal educational visit by a respected obstetrician including discussion of evidence based obstetrics, guidance on implementation, and donation of Cochrane database and other materials. Main outcome measures Rates of perineal suturing with polyglycolic acid, ventouse delivery, prophylactic antibiotics in caesarean section, and steroids in preterm delivery, before and 9 months after visits, and concordance of guidelines with review evidence for same marker practices before and after visits. Results Rates varied greatly, but the overall baseline mean of 43% (986/2312) increased to 54% (1189/2196) 9 months later. Rates of ventouse delivery increased significantly in intervention units but not in control units; there was no difference between the two types of units in uptake of other practices. Pooling rates from all 25 units, use of antibiotics in caesarean section and use of polyglycolic acid sutures increased significantly over the period, but use of steroids in preterm delivery was unchanged. Labour ward guidelines seldom agreed with evidence at baseline; this hardly improved after visits. Educational visits cost £860 each (at 1995 prices). Conclusions There was considerable uptake of evidence into practice in both control and intervention units between 1994 and 1995. Our educational visits added little to this, despite the informal setting, targeting of senior staff from two disciplines, and donation of educational materials. Further work is needed to define cost effective methods to enhance the uptake of evidence from systematic reviews and to clarify leadership and roles of senior obstetric staff in implementing the evidence. Key messagesThere was marked variation in four common obstetric practices known to improve patient outcomes in 25 district general obstetric units across south east England in both 1994 and 1995Labour ward guidelines in the 25 units showed little concordance with Cochrane review evidence in 1994 and 1995The gap between Cochrane review evidence and clinical practice narrowed in 1995, but 46% (1010) of 2196 pregnant women studied were still not managed according to current evidenceEducational visits to senior staff led to a significant but clinically modest uptake of evidence from systematic reviews in only one of the four practices studiedReducing practice variations and improving clinical knowledge management by helping clinicians to locate, select, and implement systematic review evidence remain important challenges for the NHS PMID:9774287

The impact of presumed consent legislation on cadaveric organ donation: a cross-country study.

PubMed

Abadie, Alberto; Gay, Sebastien

2006-07-01

In the U.S., Great Britain and in many other countries, the gap between the demand and the supply of human organs for transplantation is on the rise, despite the efforts of governments and health agencies to promote donor registration. In some countries of continental Europe, however, cadaveric organ procurement is based on the principle of presumed consent. Under presumed consent legislation, a deceased individual is classified as a potential donor in absence of explicit opposition to donation before death. This article analyzes the impact of presumed consent laws on donation rates. For this purpose, we construct a dataset on organ donation rates and potential factors affecting organ donation for 22 countries over a 10-year period. We find that while differences in other determinants of organ donation explain much of the variation in donation rates, after controlling for those determinants presumed consent legislation has a positive and sizeable effect on organ donation rates. We use the panel structure of our dataset to test and reject the hypothesis that unmeasured determinants of organ donation rates confound our empirical results.

The Supply of and Demand for Charitable Donations to Higher Education. NBER Working Paper No. 18389

ERIC Educational Resources Information Center

Brown, Jeffrey R.; Dimmock, Stephen G.; Weisbenner, Scott

2012-01-01

Charitable donations are an important revenue source for many institutions of higher education. We explore how donations respond to economic and financial market shocks, accounting for both supply and demand channels through which these shocks operate. In panel data with fixed effects to control for unobservable differences across universities, we…

Making families: organizational boundary work in US egg and sperm donation.

PubMed

Johnson, Katherine M

2013-12-01

Egg and sperm donation can create distinct issues for designating family boundaries. These issues come to the forefront as relations between donors, recipients, and donor-conceived children have been shifting from anonymous to more open arrangements in the US and other western countries. In this study, I address US organizational practices and family boundary construction. Fertility clinics, egg donation agencies, and sperm banks are central providers of US gamete donation services. Given the disruptive potential of gamete donation, how do they manage relationships between parties? Through a content analysis of materials from twenty fertility clinics, twenty egg donation agencies, and thirty-one sperm banks, I address three major strategies of organizational boundary work: 1) creating identity categories, 2) managing information, and 3) managing interaction. I ultimately argue that even as many organizations offer opportunities for connections between parties, they exercise social control over donation arrangements through bounded relationships. Copyright © 2013 Elsevier Ltd. All rights reserved.

Organ and tissue donation in clinical settings: a systematic review of the impact of interventions aimed at health professionals

PubMed Central

2014-01-01

In countries where presumed consent for organ donation does not apply, health professionals (HP) are key players for identifying donors and obtaining their consent. This systematic review was designed to verify the efficacy of interventions aimed at HPs to promote organ and tissue donation in clinical settings. CINAHL (1982 to 2012), COCHRANE LIBRARY, EMBASE (1974 to 2012), MEDLINE (1966 to 2012), PsycINFO (1960 to 2012), and ProQuest Dissertations and Theses were searched for papers published in French or English until September 2012. Studies were considered if they met the following criteria: aimed at improving HPs’ practices regarding the donation process or at increasing donation rates; HPs working in clinical settings; and interventions with a control group or pre-post assessments. Intervention behavioral change techniques were analyzed using a validated taxonomy. A risk ratio was computed for each study having a control group. A total of 15 studies were identified, of which only 5 had a control group. Interventions were either educational, organizational or a combination of both, and had a weak theoretical basis. The most common behavior change technique was providing instruction. Two sets of interventions showed a significant risk ratio. However, most studies did not report the information needed to compute their efficacy. Therefore, interventions aimed at improving the donation process or at increasing donation rates should be based on sound theoretical frameworks. They would benefit from more rigorous evaluation methods to ensure good knowledge translation and appropriate organizational decisions to improve professional practices. PMID:24628967

Is a controlled randomised trial the non-plus-ultra design? A contribution to discussion on comparative, controlled, non-randomised trials.

PubMed

Gaus, Wilhelm; Muche, Rainer

2013-05-01

Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed consent for randomisation and masking of therapies according to today's legal and ethical standards. We do not want to de-rate CRTs, but we would like to contribute to the discussion on clinical research methodology. Informed consent to a CRT and masking of therapies plainly select patients. The excellent internal validity of CRTs can be counterbalanced by poor external validity, because internal and external validity act as antagonists. In a CRT, patients may feel like guinea pigs, this can decrease compliance, cause protocol violations, reduce self-healing properties, suppress unspecific therapeutic effects and possibly even modify specific efficacy. A control group (comparative study) is most important for the degree of evidence achieved by a trial. Study control by detailed protocol and good clinical practice (controlled study) is second in importance and randomisation and masking is third (thus the sequence CRT instead of RCT). Controlled non-randomised trials are just as ambitious and detailed as CRTs. We recommend clinicians and biometricians to take high quality controlled non-randomised trials into consideration more often. They combine good internal and external validity, better suit daily medical practice, show better patient compliance and fewer protocol violations, deliver estimators unbiased by alienated patients, and perhaps provide a clearer explanation of the achieved success. Copyright © 2013 Elsevier Inc. All rights reserved.

Evaluation of an educational, theater-based intervention on attitudes toward organ donation in Risaralda, Colombia

PubMed Central

Buitrago, Juliana; Gómez, Sandra; Guerra, Alvaro; Lucumí, Leidy; Romero, César

2013-01-01

Introduction: The shortage of organs for transplantation is a worldwide problem and the main cause is the refusal of family members to donate. Consent to donate is influenced by many factors and educational interventions are strongly recommended. Objective: To evaluate the impact of an educational, theaterbased strategy on the attitudes toward organ donation. Methods: This study employed an intervention using theater as the central tool. The impact of this intervention on the intention to donate was assessed through a controlled, prospective, nonrandomized designed study. The sample consisted of 1,038 people. All the participants answered a survey that asked about sex, age and intent to donate. Afterward, one portion of the sample was exposed to the play, The Gift of Life, and a subsequent discussion forum that was guided by experts. The same survey was administered again after the intervention. Results: Before the intervention, donation attitudes were positive in 68.3% of the responses, negative in 6.8% and uncertain in 24.9%. Females showed a greater intent to donate while age had no apparent influence on the donation decision. Those exposed to the intervention were found to be more likely to donate and show a favorable change in attitude toward donation than those who were not exposed to the intervention. Conclusion: An educational intervention using theater is an effective tool to generate a short-term change in the intent to donate. Educational strategies should be employed to increase the rates of organ donation. PMID:24892320

COMmunication with Families regarding ORgan and Tissue donation after death in intensive care (COMFORT): protocol for an intervention study.

PubMed

Potter, Julie E; Herkes, Robert G; Perry, Lin; Elliott, Rosalind M; Aneman, Anders; Brieva, Jorge L; Cavazzoni, Elena; Cheng, Andrew T H; O'Leary, Michael J; Seppelt, Ian M; Gebski, Val

2017-01-17

Discussing deceased organ donation can be difficult not only for families but for health professionals who initiate and manage the conversations. It is well recognised that the methods of communication and communication skills of health professionals are key influences on decisions made by families regarding organ donation. This multicentre study is being performed in nine intensive care units with follow-up conducted by the Organ and Tissue Donation Service in New South Wales (NSW) Australia. The control condition is pre-intervention usual practice for at least six months before each site implements the intervention. The COMFORT intervention consists of six elements: family conversations regarding offers for organ donation to be led by a "designated requester"; family offers for donation are deferred to the designated requester; the offer of donation is separated from the end-of-life discussion that death is inevitable; it takes place within a structured family donation conversation using a "balanced" approach. Designated requesters may be intensivists, critical care nurses or social workers prepared by attending the three-day national "Family Donation Conversation" workshops, and the half-day NSW Simulation Program. The design is pre-post intervention to compare rates of family consent for organ donation six months before and under the intervention. Each ICU crosses from using the control to intervention condition after the site initiation visit. The primary endpoint is the consent rate for deceased organ donation calculated from 140 eligible next of kin families. Secondary endpoints are health professionals' adherence rates to core elements of the intervention; identification of predictors of family donation decision; and the proportion of families who regret their final donation decision at 90 days. The pragmatic design of this study may identify 'what works' in usual clinical settings when requesting organ donation in critical care areas, both in terms of changes in practice healthcare professionals are willing and able to adopt, and the effect this may have on desired outcomes. The findings of this study will be indicative of the potential benefits of the intervention and be relevant and transferrable to clinical settings in other states and countries. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000815763 (24 July 2013). ClinicalTrials.gov: NCT01922310 (14 August 2013) (retrospectively registered).

Vaccine testing for emerging infections: the case for individual randomisation

PubMed Central

Eyal, Nir; Lipsitch, Marc

2017-01-01

During the 2014–2015 Ebola outbreak in Guinea, Liberia and Sierra Leone, many opposed the use of individually randomised controlled trials to test candidate Ebola vaccines. For a raging fatal disease, they explained, it is unethical to relegate some study participants to control arms. In Zika and future emerging infections, similar opposition may hinder urgent vaccine research, so it is best to address these questions now. This article lays out the ethical case for individually randomised control in testing vaccines against many emerging infections, including lethal infections in low-income countries, even when at no point in the trial do the controls receive the countermeasures being tested. When individual randomisation is feasible—and it often will be—it tends to save more lives than alternative designs would. And for emerging infections, individual randomisation also tends as such to improve care, access to the experimental vaccine and prospects for all participants relative to their opportunities absent the trial, and no less than alternative designs would. That obtains even under placebo control and without equipoise—requiring which would undermine individual randomisation and the alternative designs that opponents proffered. Our arguments expound four often-neglected factors: benefits to non-participants, benefits to participants once a trial is over including post-trial access to the study intervention, participants’ prospects before randomisation to arms and the near-inevitable disparity between arms in any randomised controlled trial. PMID:28396558

Serum uric acid levels and multiple health outcomes: umbrella review of evidence from observational studies, randomised controlled trials, and Mendelian randomisation studies.

PubMed

Li, Xue; Meng, Xiangrui; Timofeeva, Maria; Tzoulaki, Ioanna; Tsilidis, Konstantinos K; Ioannidis, John PA; Campbell, Harry; Theodoratou, Evropi

2017-06-07

Objective  To map the diverse health outcomes associated with serum uric acid (SUA) levels. Design  Umbrella review. Data sources  Medline, Embase, Cochrane Database of Systematic Reviews, and screening of citations and references. Eligibility criteria  Systematic reviews and meta-analyses of observational studies that examined associations between SUA level and health outcomes, meta-analyses of randomised controlled trials that investigated health outcomes related to SUA lowering treatment, and Mendelian randomisation studies that explored the causal associations of SUA level with health outcomes. Results  57 articles reporting 15 systematic reviews and144 meta-analyses of observational studies (76 unique outcomes), 8 articles reporting 31 meta-analyses of randomised controlled trials (20 unique outcomes), and 36 articles reporting 107 Mendelian randomisation studies (56 unique outcomes) met the eligibility criteria. Across all three study types, 136 unique health outcomes were reported. 16 unique outcomes in meta-analyses of observational studies had P<10 -6 , 8 unique outcomes in meta-analyses of randomised controlled trials had P<0.001, and 4 unique outcomes in Mendelian randomisation studies had P<0.01. Large between study heterogeneity was common (80% and 45% in meta-analyses of observational studies and of randomised controlled trials, respectively). 42 (55%) meta-analyses of observational studies and 7 (35%) meta-analyses of randomised controlled trials showed evidence of small study effects or excess significance bias. No associations from meta-analyses of observational studies were classified as convincing; five associations were classified as highly suggestive (increased risk of heart failure, hypertension, impaired fasting glucose or diabetes, chronic kidney disease, coronary heart disease mortality with high SUA levels). Only one outcome from randomised controlled trials (decreased risk of nephrolithiasis recurrence with SUA lowering treatment) had P<0.001, a 95% prediction interval excluding the null, and no large heterogeneity or bias. Only one outcome from Mendelian randomisation studies (increased risk of gout with high SUA levels) presented convincing evidence. Hypertension and chronic kidney disease showed concordant evidence in meta-analyses of observational studies, and in some (but not all) meta-analyses of randomised controlled trials with respective intermediate or surrogate outcomes, but they were not statistically significant in Mendelian randomisation studies. Conclusion  Despite a few hundred systematic reviews, meta-analyses, and Mendelian randomisation studies exploring 136 unique health outcomes, convincing evidence of a clear role of SUA level only exists for gout and nephrolithiasis. 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.

Post-operative course of coronary artery bypass surgery patients who pre-donate autologous blood.

PubMed

Jovin, Ion S; Stelzig, Georg; Strelitz, Joachim C; Taborski, Uwe; Jovin, Angelika; Heidinger, Kathrin; Klövekorn, Wolf-Peter; Müller-Berghaus, Gert

2003-12-01

Pre-operative autologous blood donation is used to reduce the need of allogeneic blood in patients undergoing coronary bypass surgery operations, but it is not clear what impact the blood donation has on the post-operative course of these patients. We studied the post-operative course of 210 patients who pre-donated autologous blood before their coronary bypass operation (donors) and of 67 patients who were eligible to pre-donate but did not (controls). The clinical variables and the technical operative parameters of the patients in the two groups were similar. There was no significant difference between the duration of assisted ventilation post-operatively (756 +/- 197 vs. 802 +/- 395 min; P=0.54) or length of stay in the intensive care unit (1.8 +/- 1.1 vs. 1.7 +/- 0.9 days; P=0.52) of the two groups. The number of autologous units of packed red cells and of fresh frozen plasma (FFP) received by the donors was significantly higher than the number of units of allogeneic packed red cells (1.5 +/- 0.9 vs. 0.3 +/- 0.9; P=0.001) and the units of homologous FFP received by the controls (2.3 +/- 0.8 vs. 0.6 +/- 1; P=0.001). We found no evidence that autologous blood donation exerted a negative influence on the post-operative course of patients undergoing coronary bypass surgery. Patients who pre-donated blood received no allogeneic blood products, but the number of autologous blood products received by donors was higher than the number of blood products received by patients who did not pre-donate.

A study of the effect of message framing on oocyte donation.

PubMed

Purewal, S; van den Akker, O B A

2009-12-01

The aims of this study were to examine the effect of gain- and loss-framed messages on British and South East Asian women's intentions towards oocyte donation and to examine whether the components of the theory of planned behaviour influenced the relationship between framing and intentions. A total of 406 women participated in this study (mean age = 22, SD = 2.9). There were 211 participants in the gain condition and 195 in the loss condition. An analysis of covariance found a main effect for framing (F(1, 402) = 6.3; P < 0.01) after controlling for existing attitudes towards oocyte donation and pre-message intentions to donate. Specifically, participants in the gain-framed condition were significantly more likely to report higher post-message intentions to donate oocytes than participants in the loss condition. However, the framing effect was only observed with British populations and not with women from South East Asia. Further, structural equation modelling analyses revealed lower levels of 'perceived behavioural control' (beta = -0.420, P < 0.03) and positive attitudes towards 'the importance of genetic ties between parent and child' (beta = 0.70, P < 0.001) were direct predictors of post-message intentions in the gain (but not loss) frame condition. Findings obtained from this study indicate that oocyte donation campaigns should consider using gain-framed messages in recruitment appeals and message frames should be matched to the target populations' perceived level of behavioural control.

Assessment of blood donation intention among medical students in Pakistan--An application of theory of planned behavior.

PubMed

Faqah, Anadil; Moiz, Bushra; Shahid, Fatima; Ibrahim, Mariam; Raheem, Ahmed

2015-12-01

Theory of Planned Behavior proposes a model which can measure how human actions are guided. It has been successfully utilized in the context of blood donation. We employed a decision-making framework to determine the intention of blood donation among medical students who have never donated blood before the study. Survey responses were collected from 391 medical students from four various universities on a defined questionnaire. The tool composed of 20 questions that were formulated to explain donation intention based on theory of planned behavior. The construct included questions related to attitude, subjective norm and perceived behavior control, descriptive norm, moral norm, anticipated regret, donation anxiety and religious norm. Pearson's correlational relationships were measured between independent and dependent variables of intention to donate blood. ANOVA was applied to observe the model fit; a value of 0.000 was considered statistically significant. A multiple regression analysis was conducted to explore the relative importance of the main independent variables in the prediction of intention. Multi-collinearity was also evaluated to determine that various independent variables determine the intention. The reliability of measures composed of two items was assessed using inter-item correlations. Three hundred and ninety-one medical students (M:F; 1:2.2) with mean age of 21.96 years ± 1.95 participated in this study. Mean item score was 3.8 ± 0.83. Multiple regression analysis suggested that perceived behavioral control, anticipated regret and attitude were the most influential factors in determining intention of blood donation. Donation anxiety was least correlated and in fact bore a negative correlation with intention. ANOVA computed an F value of 199.082 with a p-value of 0.000 indicating fitness of model. The value of R square and adjusted R square was 0.811 and 0.807 respectively indicating strong correlation between various independent and dependent variables. Medical students as novice blood donors showed a positive attitude toward blood donation. Theory of planned behavior can be successfully utilized in determining the antecedents toward blood donation behavior. Copyright © 2015 Elsevier Ltd. All rights reserved.

No evidence that a range of artificial monitoring cues influence online donations to charity in an MTurk sample.

PubMed

Saunders, Timothy J; Taylor, Alex H; Atkinson, Quentin D

2016-10-01

Monitoring cues, such as an image of a face or pair of eyes, have been found to increase prosocial behaviour in several studies. However, other studies have found little or no support for this effect. Here, we examined whether monitoring cues affect online donations to charity while manipulating the emotion displayed, the number of watchers and the cue type. We also include as statistical controls a range of likely covariates of prosocial behaviour. Using the crowdsourcing Internet marketplace, Amazon Mechanical Turk (MTurk), 1535 participants completed our survey and were given the opportunity to donate to charity while being shown an image prime. None of the monitoring primes we tested had a significant effect on charitable giving. By contrast, the control variables of culture, age, sex and previous charity giving frequency did predict donations. This work supports the importance of cultural differences and enduring individual differences in prosocial behaviour and shows that a range of artificial monitoring cues do not reliably boost online charity donation on MTurk.

No evidence that a range of artificial monitoring cues influence online donations to charity in an MTurk sample

PubMed Central

Saunders, Timothy J.; Atkinson, Quentin D.

2016-01-01

Monitoring cues, such as an image of a face or pair of eyes, have been found to increase prosocial behaviour in several studies. However, other studies have found little or no support for this effect. Here, we examined whether monitoring cues affect online donations to charity while manipulating the emotion displayed, the number of watchers and the cue type. We also include as statistical controls a range of likely covariates of prosocial behaviour. Using the crowdsourcing Internet marketplace, Amazon Mechanical Turk (MTurk), 1535 participants completed our survey and were given the opportunity to donate to charity while being shown an image prime. None of the monitoring primes we tested had a significant effect on charitable giving. By contrast, the control variables of culture, age, sex and previous charity giving frequency did predict donations. This work supports the importance of cultural differences and enduring individual differences in prosocial behaviour and shows that a range of artificial monitoring cues do not reliably boost online charity donation on MTurk. PMID:27853533

Effect of Repeated Whole Blood Donations on Aerobic Capacity and Hemoglobin Mass in Moderately Trained Male Subjects: A Randomized Controlled Trial.

PubMed

Meurrens, Julie; Steiner, Thomas; Ponette, Jonathan; Janssen, Hans Antonius; Ramaekers, Monique; Wehrlin, Jon Peter; Vandekerckhove, Philippe; Deldicque, Louise

2016-12-01

The aims of the present study were to investigate the impact of three whole blood donations on endurance capacity and hematological parameters and to determine the duration to fully recover initial endurance capacity and hematological parameters after each donation. Twenty-four moderately trained subjects were randomly divided in a donation (n = 16) and a placebo (n = 8) group. Each of the three donations was interspersed by 3 months, and the recovery of endurance capacity and hematological parameters was monitored up to 1 month after donation. Maximal power output, peak oxygen consumption, and hemoglobin mass decreased (p < 0.001) up to 4 weeks after a single blood donation with a maximal decrease of 4, 10, and 7%, respectively. Hematocrit, hemoglobin concentration, ferritin, and red blood cell count (RBC), all key hematological parameters for oxygen transport, were lowered by a single donation (p < 0.001) and cumulatively further affected by the repetition of the donations (p < 0.001). The maximal decrease after a blood donation was 11% for hematocrit, 10% for hemoglobin concentration, 50% for ferritin, and 12% for RBC (p < 0.001). Maximal power output cumulatively increased in the placebo group as the maximal exercise tests were repeated (p < 0.001), which indicates positive training adaptations. This increase in maximal power output over the whole duration of the study was not observed in the donation group. Maximal, but not submaximal, endurance capacity was altered after blood donation in moderately trained people and the expected increase in capacity after multiple maximal exercise tests was not present when repeating whole blood donations.

The 'donations for decreased ALT (D4D)' prosocial behavior incentive scheme for NAFLD patients.

PubMed

Sumida, Yoshio; Yoshikawa, Toshikazu; Tanaka, Saiyu; Taketani, Hiroyoshi; Kanemasa, Kazuyuki; Nishimura, Tekeshi; Yamaguchi, Kanji; Mitsuyoshi, Hironori; Yasui, Kohichiroh; Minami, Masahito; Naito, Yuji; Itoh, Yoshito

2014-12-01

Physicians often experience difficulties in motivating patients with non-alcoholic fatty liver disease (NAFLD) to undergo lifestyle changes. The aim of this study is to examine whether 'Donations for Decreased alanine aminotransferase (ALT)' (D4D) prosocial behavior incentive can serve as an effective intrinsic motivational factor in comparison with conventional dietary and exercise intervention alone for NAFLD patients. Twenty-five NAFLD patients with elevated ALT were randomly assigned to a control group that received conventional dietary and exercise intervention alone, or a donation group whereby, as an incentive, we would make a monetary donation to the United Nations World Food Programme (WFP) based on the decrease in their ALT levels achieved over 12 weeks, in addition to receiving control intervention. In a donation group, we would donate US$1 to the WFP for every 1 IU/l of decrease in their ALT levels. There were no differences of pre-treatment clinical characteristics between the two groups. Significant reductions of ALT levels were achieved only in a donation group, although post-treatment ALT levels were not different between the two groups. These patients raised a total of $316 for the WFP. Promoting patients' intrinsic motivation by incorporating 'D4D' prosocial behavior incentive into conventional dietary and exercise intervention may provide a means to improve NAFLD. © The Author 2013. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Donation protocol following controlled cardiac death (Maastricht type III donation). First experience].

PubMed

Rubio-Muñoz, J J; Pérez-Redondo, M; Alcántara-Carmona, S; Lipperheide-Vallhonrat, I; Fernández-Simón, I; Valdivia-de la Fuente, M; Villanueva-Fernández, H; Balandín-Moreno, B; Ortega-López, A; Romera-Ortega, M A; Galdos-Anuncibay, P

2014-03-01

To present our experience with the implementation of a donation protocol following controlled cardiac death (Maastricht type III donation). A retrospective descriptive and observational study was made. Intensive Care Unit of a third-level university hospital. Eight patients in an irreversible state, in which withdrawal of all life support had been agreed, were evaluated as potential donors. Application of the adopted protocol. Clinical data of donors, evaluation of a donation protocol following cardiac death, warm ischemia times, and short-term outcome of the recipients. Eight patients were evaluated. In one case donation was not possible because no cardiac arrest developed in the 120 minutes after extubation. The 7 remaining patients were effective kidney donors. Warm ischemia times were less than 23 minutes in all cases. Although 7 of the 14 recipients suffered delayed graft function, all of them achieved good renal function. Donation after cardiac death in patients in an overwhelming and irreversible state represents a potential source of donors not previously considered in this country. The prior development of a consensus-based protocol can help increase the number of organs in combination with those obtained after brain death. In our experience, the results of kidney transplants obtained from donors after cardiac death are good, and the success of these types of protocols could be extended to other organs such as the liver and lungs. Copyright © 2012 Elsevier España, S.L. and SEMICYUC. All rights reserved.

Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry.

PubMed

Li, Alvin H; Garg, Amit X; Prakash, Versha; Grimshaw, Jeremy M; Taljaard, Monica; Mitchell, Joanna; Matti, Danny; Linklater, Stefanie; Naylor, Kyla L; Dixon, Stephanie; Faulds, Cathy; Bevan, Rachel; Getchell, Leah; Knoll, Greg; Kim, S Joseph; Sontrop, Jessica; Bjerre, Lise M; Tong, Allison; Presseau, Justin

2017-12-21

There is a worldwide shortage of organs available for transplant, leading to preventable mortality associated with end-stage organ disease. While most citizens in many countries with an intent-to-donate "opt-in" system support organ donation, registration rates remain low. In Canada, most Canadians support organ donation but less than 25% in most provinces have registered their desire to donate their organs when they die. The family physician office is a promising yet underused setting in which to promote organ donor registration and address known barriers and enablers to registering for deceased organ and tissue donation. We developed a protocol to evaluate an intervention to promote registration for organ and tissue donation in family physician waiting rooms. This protocol describes a planned, stepped-wedge, cluster randomized registry trial in six family physician offices in Ontario, Canada to evaluate the effectiveness of reception staff providing patients with a pamphlet that addresses barriers and enablers to registration including a description of how to register for organ donation. An Internet-enabled tablet will also be provided in waiting rooms so that interested patients can register while waiting for their appointments. Family physicians and reception staff will be provided with training and/or materials to support any conversations about organ donation with their patients. Following a 2-week control period, the six offices will cross sequentially into the intervention arm in randomized sequence at 2-week intervals until all offices deliver the intervention. The primary outcome will be the proportion of patients visiting the office who are registered organ donors 7 days following their office visit. We will evaluate this outcome using routinely collected registry data from provincial administrative databases. A post-trial qualitative evaluation process will assess the experiences of reception staff and family physicians with the intervention and the stepped-wedge trial design. Promoting registration for organ donation in family physician offices is a potentially useful strategy for increasing registration for organ donation. Increased registration may ultimately help to increase the number of organs available for transplant. The results of this trial will provide important preliminary data on the effectiveness of using family physician offices to promote registration for organ donation. ClinicalTrials.gov, ID: NCT03213171 . Registered on 11 July 2017.

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.

Motivating Cord Blood Donation with Information and Behavioral Nudges.

PubMed

Grieco, Daniela; Lacetera, Nicola; Macis, Mario; Di Martino, Daniela

2018-01-10

Umbilical cord blood is a source of hematopoietic stem cells essential to treat life-threatening diseases, such as leukemia and lymphoma. However, only a very small percentage of parents donate upon delivery. The decision to donate the cord blood occurs at a very specific time and when parents likely experience emotional, informational, and decisional overloads; these features of cord blood donation make it different from other pro-social activities. In collaboration with an OB-GYN clinic in Milan, Italy, we conducted the first randomized controlled trial that applies tools from behavioral science to foster cord blood donation, and quantified the gains that informational and behavioral "nudges" can achieve. We found that information and "soft" commitments increased donations; approaching expecting parents closer to the delivery date and providing them with multiple reminders, moreover, had the strongest impact. However, a significant portion of women who expressed consent to donate could not do so because of organizational constraints. We conclude that simple, non-invasive behavioral interventions that address information gaps and procrastination, and that increase the salience of the activity can substantially enhance altruistic donations of cord blood, especially when coupled with organizational support.

Vaccine testing for emerging infections: the case for individual randomisation.

PubMed

Eyal, Nir; Lipsitch, Marc

2017-09-01

During the 2014-2015 Ebola outbreak in Guinea, Liberia and Sierra Leone, many opposed the use of individually randomised controlled trials to test candidate Ebola vaccines. For a raging fatal disease, they explained, it is unethical to relegate some study participants to control arms. In Zika and future emerging infections, similar opposition may hinder urgent vaccine research, so it is best to address these questions now. This article lays out the ethical case for individually randomised control in testing vaccines against many emerging infections, including lethal infections in low-income countries, even when at no point in the trial do the controls receive the countermeasures being tested. When individual randomisation is feasible-and it often will be-it tends to save more lives than alternative designs would. And for emerging infections, individual randomisation also tends as such to improve care, access to the experimental vaccine and prospects for all participants relative to their opportunities absent the trial, and no less than alternative designs would. That obtains even under placebo control and without equipoise-requiring which would undermine individual randomisation and the alternative designs that opponents proffered. Our arguments expound four often-neglected factors: benefits to non-participants, benefits to participants once a trial is over including post-trial access to the study intervention, participants' prospects before randomisation to arms and the near-inevitable disparity between arms in any randomised controlled trial. 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/.

Prevalence of selected viral infections among temporarily deferred donors who returned to donate blood: American Red Cross blood donor study.

PubMed

Zou, Shimian; Musavi, Fatemeh; Notari, Edward P; Fujii, Karen E; Dodd, Roger Y

2005-10-01

Health history questions are introduced into the predonation interview to identify blood donors believed to pose a higher risk of infectious diseases to recipients. This study assesses the current impact of some of those questions. Donor deferral and donation data were extracted from a research database of the American Red Cross. The prevalence of hepatitis B surface antigen or antibodies to human immunodeficiency virus, hepatitis C virus, or human T-lymphotropic virus was obtained for different groups of donors who were temporarily deferred in 2000 through 2001 and later returned to donate blood in 2000 through 2003. The results were compared with either first-time or repeat donors in 2000 through 2003, while controlling for differences in sex, age, and year of donation. Of donors temporarily deferred in 2000 through 2001 who had had no donation or deferral during the previous 2 years, only 22.08 percent subsequently returned to donate blood in 2000 through 2003. Donations from returning donors who had been deferred for potential infectious disease risk did not show a higher prevalence for any of the viral markers when those with no donation or deferral during the previous two years were compared with first-time donations, and those with prior donation were compared with repeat donations. Blood donors temporarily deferred in 2000 through 2001 for potential risk of viral infection who later returned to donate blood did not appear to pose a higher risk compared to first-time or repeat donors. The effectiveness of some of the currently used deferral questions in reducing viral risks warrants further study.

Attitudes of Australian chiropractic students toward whole body donation: a cross-sectional study.

PubMed

Alexander, Michelle; Marten, Mathew; Stewart, Ella; Serafin, Stanley; Štrkalj, Goran

2014-01-01

Cadavers play an important role in anatomy education. In Australia, bodies for anatomy education are acquired only through donations. To gain insight into educational dynamics in an anatomy laboratory as well as to facilitate body donation programs and thanksgiving ceremonies, it is important to understand students' attitudes toward body donation. In this cross-sectional study, the attitudes of Macquarie University's first, second, and fifth year chiropractic students toward body donation were investigated. Macquarie University chiropractic students have a four semester long anatomy program, which includes cadaver-based instruction on prosected specimens. A questionnaire was used to record respondents' demographics and attitudes toward body donation: personal, by a relative, and by a stranger. It was found that ethnicity and religion affect attitudes toward body donation, with Australian students being more willing to donate a stranger's body and atheists and agnostics being more willing to donate in general. Furthermore, willingness to donate one's own or a family member's body decreases as year of study increases, suggesting a possible negative impact of exposure to cadavers in the anatomy laboratory. This was only true, however, after controlling for age. Thus, the impact of viewing and handling prosected specimens, which is the norm in anatomy classes in Australia, may not be as strong as dissecting cadavers. It is suggested that anatomists and educators prepare students for cadaver-based instruction as well as exhibit sensitivity to cultural differences in how students approach working with cadavers, when informing different communities about body donation programs and in devising thanksgiving ceremonies. © 2013 American Association of Anatomists.

An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.

PubMed

Cockayne, Sarah; Fairhurst, Caroline; Adamson, Joy; Hewitt, Catherine; Hull, Robin; Hicks, Kate; Keenan, Anne-Maree; Lamb, Sarah E; Green, Lorraine; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Rodgers, Sara; Torgerson, David J; Vernon, Wesley; Watson, Judith; Knapp, Peter; Rick, Jo; Bower, Peter; Eldridge, Sandra; Madurasinghe, Vichithranie W; Graffy, Jonathan

2017-03-28

Randomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial. A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65)). This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study. International Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.

Presumed consent for organ preservation in uncontrolled donation after cardiac death in the United States: a public policy with serious consequences

PubMed Central

Verheijde, Joseph L; Rady, Mohamed Y; McGregor, Joan

2009-01-01

Organ donation after cessation of circulation and respiration, both controlled and uncontrolled, has been proposed by the Institute of Medicine as a way to increase opportunities for organ procurement. Despite claims to the contrary, both forms of controlled and uncontrolled donation after cardiac death raise significant ethical and legal issues. Identified causes for concern include absence of agreement on criteria for the declaration of death, nonexistence of universal guidelines for duration before stopping resuscitation efforts and techniques, and assumption of presumed intent to donate for the purpose of initiating temporary organ-preservation interventions when no expressed consent to donate is present. From a legal point of view, not having scientifically valid criteria of cessation of circulation and respiration for declaring death could lead to a conclusion that organ procurement itself is the proximate cause of death. Although the revised Uniform Anatomical Gift Act of 2006 provides broad immunity to those involved in organ-procurement activities, courts have yet to provide an opinion on whether persons can be held liable for injuries arising from the determination of death itself. Preserving organs in uncontrolled donation after cardiac death requires the administration of life-support systems such as extracorporeal membrane oxygenation. These life-support systems can lead to return of signs of life that, in turn, have to be deliberately suppressed by the administration of pharmacological agents. Finally, allowing temporary organ-preservation interventions without expressed consent is inherently a violation of the principle of respect for a person's autonomy. Proponents of organ donation from uncontrolled donation after cardiac death, on the other hand, claim that these nonconsensual interventions enhance respect for autonomy by allowing people, through surrogate decision making, to execute their right to donate organs. However, the lack of transparency and the absence of protection of individual autonomy, for the sake of maximizing procurement opportunities, have placed the current organ-donation system of opting-in in great jeopardy. Equally as important, current policies enabling and enhancing organ procurement practices, pose challenges to the constitutional rights of individuals in a pluralistic society as these policies are founded on flawed medical standards for declaring death. PMID:19772617

Presumed consent for organ preservation in uncontrolled donation after cardiac death in the United States: a public policy with serious consequences.

PubMed

Verheijde, Joseph L; Rady, Mohamed Y; McGregor, Joan

2009-09-22

Organ donation after cessation of circulation and respiration, both controlled and uncontrolled, has been proposed by the Institute of Medicine as a way to increase opportunities for organ procurement. Despite claims to the contrary, both forms of controlled and uncontrolled donation after cardiac death raise significant ethical and legal issues. Identified causes for concern include absence of agreement on criteria for the declaration of death, nonexistence of universal guidelines for duration before stopping resuscitation efforts and techniques, and assumption of presumed intent to donate for the purpose of initiating temporary organ-preservation interventions when no expressed consent to donate is present. From a legal point of view, not having scientifically valid criteria of cessation of circulation and respiration for declaring death could lead to a conclusion that organ procurement itself is the proximate cause of death. Although the revised Uniform Anatomical Gift Act of 2006 provides broad immunity to those involved in organ-procurement activities, courts have yet to provide an opinion on whether persons can be held liable for injuries arising from the determination of death itself. Preserving organs in uncontrolled donation after cardiac death requires the administration of life-support systems such as extracorporeal membrane oxygenation. These life-support systems can lead to return of signs of life that, in turn, have to be deliberately suppressed by the administration of pharmacological agents. Finally, allowing temporary organ-preservation interventions without expressed consent is inherently a violation of the principle of respect for a person's autonomy. Proponents of organ donation from uncontrolled donation after cardiac death, on the other hand, claim that these nonconsensual interventions enhance respect for autonomy by allowing people, through surrogate decision making, to execute their right to donate organs. However, the lack of transparency and the absence of protection of individual autonomy, for the sake of maximizing procurement opportunities, have placed the current organ-donation system of opting-in in great jeopardy. Equally as important, current policies enabling and enhancing organ procurement practices, pose challenges to the constitutional rights of individuals in a pluralistic society as these policies are founded on flawed medical standards for declaring death.

Inhaler Reminders Significantly Improve Asthma Patients' Use of Controller Medications

MedlinePlus

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Noncontraceptive Benefits of Birth Control Pills

MedlinePlus

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Predicting intentions to donate blood among nondonors in Australia: an extended theory of planned behavior.

PubMed

Robinson, Natalie G; Masser, Barbara M; White, Katherine M; Hyde, Melissa K; Terry, Deborah J

2008-12-01

With an increasing demand for blood and blood products in Australia, there is a continual need to recruit blood donors. As such, it is important to investigate the factors that impact on nondonors' decision-making processes with regard to donating blood for the first time. Previous research has established the efficacy of the theory of planned behavior (TPB) in predicting blood donor intentions. The current research aimed to test a TPB model augmented with constructs implicated in previous blood donor research; specifically descriptive norm, moral norm, anticipated regret, and donation anxiety. Participants completed measures assessing the standard TPB variables of attitude, subjective norm, and perceived behavioral control (PBC) as well as descriptive norm, moral norm, donation anxiety, and anticipated regret. Path analysis examined the utility of the augmented TPB model to predict 195 non-blood donors' intentions to donate blood. A final revised model provided a very good fit to the data and included attitude, PBC, moral norm, descriptive norm, anticipated regret, and donation anxiety as direct predictors of intention, with these factors accounting for 70 percent of the variance in intentions to donate blood. A revised TPB model provided a more efficacious predictor of nondonors' intentions to donate than the standard TPB model and highlights the role that norm-based factors and affective-laden constructs play in predicting non-blood donors' intentions to donate.

The impact of multiple blood donations on the risk of cardiovascular diseases: Insight of lipid profile.

PubMed

Bani-Ahmad, M A; Khabour, O F; Gharibeh, M Y; Alshlool, K N

2017-11-01

The reduction in blood viscosity and iron store were proposed to be connected to the reduction in the risk of cardiovascular disease (CVD) among multiple blood donors. Herein, we evaluated the modulation of serum lipids levels in accordance with donation events. Furthermore, atherogenic impacts on the risk of CVD were investigated. A total of 100 voluntarily male donors were included in the study. Fifty donors were multiple time donors (MTD) and 50 were single time donors (STD). Levels of serum lipids were determined and atherogenic indices including TG/HDL and CHO/HDL ratios were calculated. QRISK2 parameters were determined to evaluate the 10-years risk of developing CVD. Among MTD, there were significantly higher serum levels of triglycerides (TG) and very low-density lipoproteins (VLDL) combined with significantly lower HDL level. These modulations were significantly correlated to the extent of donation. Both CHO/HDL and TG/HDL ratios were also significantly higher among MTD. However, only TG/HDL ratio was strongly correlated to the donation extent even when controlled for age, BMI and smoking status. Despite the significant difference in QRISK2 parameters between study groups, none of these parameters was correlated to the extent of donation when controlling for age, BMI and smoking status. We demonstrate that multiple blood donation is associated with an unfavorable modulation of serum levels of lipids that is influenced by donation extent. This modulation is not associated with an increased risk of CVD but may weakly contribute in a higher risk for coronary heart disease (CHD). Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Organ donation after controlled cardiac death under Maastricht category iii: Ethical implications and end of life care.

PubMed

González-Méndez, M Isabel; López-Rodríguez, Luís

2017-12-11

The decrease in potential donation after brain death has resulted in a need to evaluate alternative sources. Donation after cardiac death is a good option. The objectives of this article are to describe the Maastricht type iii controlled organ donation characteristics and to determine end-of-life care and the role of nurses in the donation process. In this type of donation, cardiocirculatory arrest is predictable after the limitation of life sustaining treatments. These are patients for whom there are no effective therapy options and, in the context of an organised and planned practice involving all the professionals involved in the care of the patient, the decision is made, in consultation with the family, to withdraw life support measures. This limitation of life sustaining treatments is never carried out with the aim of making a Maastricht iii donation, but to avoid prolonging the dying process through useless and possibly degrading interventions. The obligation of the health team is to provide a dignified death and this not only includes the absence of pain, but the patient and their family must be guaranteed a feeling of calmness and serenity. Once the decision has been taken to withhold or withdraw measures, the nurse has an important role in the implementation of a palliative care plan in where physicians, nurses and patients/families should be involved and whose focus should be on patients' dignity and comfort, considering their physical, psychological and spiritual needs. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Legal and ethical issues of uterus transplantation.

PubMed

Dickens, Bernard M

2016-04-01

The clinically detailed report of a successful uterus transplantation and live birth in Sweden, in which a family friend donated her uterus, provides a basis for expanded practice. Family members and friends can serve as living donors without offending legal or ethical prohibitions of paid organ donation, even though family members and friends often engage in reciprocal gift exchanges. Donations from living unrelated sources are more problematic, and there is a need to monitor donors' genuine altruism and motivation. Donation by deceased women-i.e. cadaveric donation-raises issues of uterus suitability for transplantation, and how death is diagnosed. Organs' suitability for donation is often achieved by ventilation to maintain cardiac function for blood circulation, but laws and cultures could deem that a heartbeat indicates donors' live status. Issues could arise concerning ownership and control of organs between recovery from donors and implantation into recipients, and on removal following childbirth, that require legal resolution. Copyright © 2016. Published by Elsevier Ireland Ltd.

Donated blood--gift or commodity? Some economic and ethical considerations on voluntary vs commercial donation of blood.

PubMed

von Schubert, H

1994-07-01

The author applies the theory of public goods on donated blood. Donated blood may be taken as a 'public good' like water and air, police and fire brigades. This theory trends to imply a preference for voluntary donation and bloodbanking by public and nonprofit organisations as well as for low cost supply. An additional commercial supply of blood nevertheless is welcome. Quality as well as quantity of blood depend first of all on the willingness to donate and the honesty of the donors about their health. An altruistic motivation alone, which is not triggered by some material incentive, does not in all systems guarantee a sufficient quantity of safe blood. Both the altruistic as well as the reimbursement-oriented donor's willingness and honesty have to be guarded by sound practice in bloodbanking and adequate public control within a legal framework which reflects the vital role of blood supply. A legal implementation of product liability will certainly be an important instrument in this field.

Educational Web-Based Intervention for High School Students to Increase Knowledge and Promote Positive Attitudes toward Organ Donation

ERIC Educational Resources Information Center

Vinokur, Amiram D.; Merion, Robert M.; Couper, Mick P.; Jones, Eleanor G.; Dong, Yihui

2006-01-01

A sample of 490 high school students from 81 schools in Michigan participated in an experiment in which they were randomly assigned to either a control or an experimental Web site. The experimental Web site provided exposure to educational material about the process of organ donation and organ transplantation. The control Web site provided…

Association between bibliometric parameters, reporting and methodological quality of randomised controlled trials in vascular and endovascular surgery.

PubMed

Hajibandeh, Shahab; Hajibandeh, Shahin; Antoniou, George A; Green, Patrick A; Maden, Michelle; Torella, Francesco

2017-04-01

Purpose We aimed to investigate association between bibliometric parameters, reporting and methodological quality of vascular and endovascular surgery randomised controlled trials. Methods The most recent 75 and oldest 75 randomised controlled trials published in leading journals over a 10-year period were identified. The reporting quality was analysed using the CONSORT statement, and methodological quality with the Intercollegiate Guidelines Network checklist. We used exploratory univariate and multivariable linear regression analysis to investigate associations. Findings Bibliometric parameters such as type of journal, study design reported in title, number of pages; external funding, industry sponsoring and number of citations are associated with reporting quality. Moreover, parameters such as type of journal, subject area and study design reported in title are associated with methodological quality. Conclusions The bibliometric parameters of randomised controlled trials may be independent predictors for their reporting and methodological quality. Moreover, the reporting quality of randomised controlled trials is associated with their methodological quality and vice versa.

Fortuitous phenomena: on complexity, pragmatic randomised controlled trials, and knowledge for evidence-based practice.

PubMed

Thompson, Carl

2004-01-01

Many of the interventions that nurses develop and implement are in themselves complex and have to operate in situations of irreducible complexity and uncertainty. This article argues that the primary means of generating knowledge for the evidence-based deployment of complex interventions should be the pragmatic randomised controlled trial. Randomised controlled trials represent the only research design to adequately deal with that which we know and (far more importantly) that which we do not. Using the example of practice development as an exemplar for complexity, and drawing on the objections often voiced as a response to calls to make use of randomised controlled trials in nursing and nursing research, the article presents a developmental framework and some methodological solutions to problems often encountered. Randomised controlled trials, whilst undoubtedly methodologically and strategically challenging, offer the most robust basis for developing primary research knowledge on the effects of complex interventions in nursing and their active components.

Compliance with the CONSORT checklist in obstetric anaesthesia randomised controlled trials.

PubMed

Halpern, S H; Darani, R; Douglas, M J; Wight, W; Yee, J

2004-10-01

The Consolidated Standards for Reporting of Trials (CONSORT) checklist is an evidence-based approach to help improve the quality of reporting randomised controlled trials. The purpose of this study was to determine how closely randomised controlled trials in obstetric anaesthesia adhere to the CONSORT checklist. We retrieved all randomised controlled trials pertaining to the practice of obstetric anaesthesia and summarised in Obstetric Anesthesia Digest between March 2001 and December 2002 and compared the quality of reporting to the CONSORT checklist. The median number of correctly described CONSORT items was 65% (range 36% to 100%). Information pertaining to randomisation, blinding of the assessors, sample size calculation, reliability of measurements and reporting of the analysis were often omitted. It is difficult to determine the value and quality of many obstetric anaesthesia clinical trials because journal editors do not insist that this important information is made available to readers. Both clinicians and clinical researchers would benefit from uniform reporting of randomised trials in a manner that allows rapid data retrieval and easy assessment for relevance and quality.

Cancer Diagnoses after Living Kidney Donation: Linking United States Registry Data and Administrative Claims

PubMed Central

Lentine, Krista L.; Vijayan, Anitha; Xiao, Huiling; Schnitzler, Mark A.; Davis, Connie L.; Garg, Amit X.; Axelrod, David; Abbott, Kevin C.; Brennan, Daniel C.

2012-01-01

Background Mortality records identify cancer as the leading cause of death among living kidney donors, but information on the burden of cancer outside of death records is limited in this population. Methods We examined a database wherein OPTN identifiers for 4,650 living kidney donors in 1987–2007 were linked to administrative data of a U.S. private health insurer (2000–2007 claims) to identify post-donation cancer diagnoses. Skin and non-skin cancer diagnoses were ascertained from ICD-9-CM codes on billing claims. Donors were also matched one-to-one with general insurance beneficiaries by sex and age when benefits began. Diagnosis rates within observation windows were compared as rate ratios. Results The median time from donation to the end of plan insurance enrollment was 7.7 years, with a median observation period of 2.1 years. Skin cancer rates were similar among prior living donors in the observation period and non-donor controls (rate ratio 0.91, 95% CI 0.59–1.40). In contrast, the rate of total non-skin cancers was significantly less common among donors than controls (rate ratio 0.74, 95% CI 0.55–0.99), although reduced relative risk was limited to donors captured earlier in relation to donation. Several cases of cancer diagnosis (uterine, melanoma, other) were identified within the first year after donation. Prostate cancer was significantly more common among living donors compared with controls (rate ratio 3.80, 95% CI 1.42–10.2). Conclusions Continued study of cancer after kidney donation is warranted to ensure that evaluation, selection, and long-term follow-up support overall good health of the donor. PMID:22825543

Psychological factors related to donation behaviour among Chinese adults: results from a longitudinal investigation.

PubMed

Hu, H; Wang, T; Fu, Q

2017-10-01

Little is known about the psychological factors currently influencing blood donation in China. This study investigated the structure of psychological factors and their correlation with donation behaviour of adults in a transforming city in China over a 6-month period. Participants were recruited in Nanjing from May 2013 to April 2014. Preliminary focus group interviews with 102 participants were conducted to generate new items for a Theory of Planned Behaviour (TPB) questionnaire. The questionnaires were completed by 300 participants, and responses were subjected to factor analysis. We confirmed the resulting factorial structure with 861 respondents and examined the associations between these factors and donation behaviour during the next 6 months using structural equation modelling. Factor analysis and structural equation modelling of the data supported an extended TPB model with self-reported past donation behaviour as a covariate. After controlling for past donation behaviour, attitudes towards blood donation (β = 0·288), subjective norm (β = 0·149), self-efficacy (β = 0·199), trust in third-party health professionals (β = 0·237), mistrust towards blood collection agencies (BCAs) (β = -0·085) and traditional Chinese beliefs (β = -0·046) were significantly related to donation intention, whilst donation intention was positively (β = 0·212) associated with donation behaviour. These findings confirm that psychological factors such as attitudes are predictors of blood donation. Recruitment efforts using public information campaigns and interpersonal communications should focus on strengthening positive attitudes, increasing trust in third-party health professionals, elevating self-efficacy, changing traditional Chinese beliefs and relieving mistrust in blood collection agencies (BCAs). © 2017 British Blood Transfusion Society.

A protocol for a systematic review of non-randomised evaluations of strategies to improve participant recruitment to randomised controlled trials.

PubMed

Gardner, Heidi R; Fraser, Cynthia; MacLennan, Graeme; Treweek, Shaun

2016-08-02

Randomised controlled trials guard against selection bias and therefore offer the fairest way of evaluating healthcare interventions such as medicinal products, devices and services. Recruitment to trials can be extremely difficult, and poor recruitment can lead to extensions to both time and budget and may result in an underpowered study which does not satisfactorily answer the original research question. In the worst cases, a trial may be abandoned, causing huge waste. The evidence to support the choice of recruitment interventions is currently weak. Non-randomised evaluations of recruitment interventions are currently rejected on grounds of poor methodological quality, but systematic evaluation and assessment of this substantial body of work (using Grading of Recommendations Assessment, Development and Evaluation (GRADE) where possible) may provide useful information to support and inform the recruitment decisions of trialists and the research priorities of methodology researchers. The following databases will be searched for relevant studies: Cochrane Methodology Register, MEDLINE, EMBASE, CINAHL and PsycINFO. Any non-randomised study that includes a comparison of two or more interventions to improve recruitment to randomised controlled trials will be included. We will not apply any restrictions on publication date, language or journal. The primary outcome will be the number of individuals or centres recruited into a randomised controlled trial. The secondary outcome will be cost per recruit. Two reviewers will independently screen abstracts for eligible studies, and then, full texts of potentially relevant records will be reviewed. Disagreements will be resolved through discussion. The methodological quality of studies will be assessed using the Cochrane risk of bias tool for non-randomised studies, and the GRADE system will be used if studies are pooled. This review aims to summarise the evidence on methods used to improve recruitment to randomised controlled trials. Carrying out a systematic review including only data from non-randomised studies is a novel approach, and one which some may argue is futile. However, we believe that the systematic evaluation of what is likely to be a substantial amount of research activity is necessary, worthwhile, and will yield valuable results for the clinical trials community regardless of whether the outcomes find in favour of one or more interventions. Should the results of this review suggest that non-randomised evaluations do have something to offer trialists planning their recruitment strategies, the review may be combined in the future with the Cochrane review of randomised evaluations to produce a full review of recruitment strategies encompassing both randomised and non-randomised evaluation methods. PROSPERO CRD42016037718.

Motivations behind donations for health-related organizations: Threat appraisal and coping appraisal-the case of the ALS Ice Bucket Challenge.

PubMed

Li, Jo-Yun; Wen, Jing

2017-01-01

This study explores the influence of social media involvement and other factors on individuals' donation intentions in the context of the ALS Ice Bucket Challenge. An online survey with 306 participants revealed that social media involvement had a direct effect on intentions to contribute donations and had an indirect effect that was mediated by the response efficacy on intentions after controlling for individuals' issue involvement with the disease.

Stress influences environmental donation behavior in men.

PubMed

Sollberger, Silja; Bernauer, Thomas; Ehlert, Ulrike

2016-01-01

Stress has been found to have both positive and negative effects on prosocial behavior, suggesting the involvement of moderating factors such as context and underlying motives. In the present study, we investigated the conditions under which acute stress leads to an increase vs. decrease in environmental donation behavior as an indicator of prosocial behavior. In particular, we examined whether the effects of stress depended on preexisting pro-environmental orientation and stage of the donation decision (whether or not to donate vs. the amount to be donated). Male participants with either high (N=40) or low (N=39) pro-environmental orientation were randomly assigned to a social stress test or a control condition. Salivary cortisol was assessed repeatedly before and after stress induction. At the end of the experiment, all subjects were presented with an opportunity to donate a portion of their monetary compensation to a climate protection foundation. We found that stress significantly increased donation frequency, but only in subjects with low pro-environmental orientation. Congruously, their decision to donate was positively associated with cortisol response to the stress test and the emotion regulation strategy mood repair, as well as accompanied by an increase in subjective calmness. In contrast, among the participants who decided to donate, stress significantly reduced the donated amount of money, regardless of pro-environmental orientation. In conclusion, our findings suggest that acute stress might generally activate more self-serving motivations, such as making oneself feel better and securing one's own material interests. Importantly, however, a strong pro-environmental orientation partially prevented these effects. Copyright © 2015 Elsevier Ltd. All rights reserved.

Financial incentives for kidney donation: A comparative case study using synthetic controls.

PubMed

Bilgel, Fırat; Galle, Brian

2015-09-01

Although many commentators called for increased efforts to incentivize organ donations, theorists and some evidence suggest these efforts will be ineffective. Studies examining the impact of tax incentives generally report zero/negative coefficients, but these studies incorrectly define their tax variables and rely on difference-in-differences despite likely failures of the parallel trends assumption. We identify the causal effect of tax legislation to serve as an organ donor on living kidney donation rates in the U.S. states using more precise tax data and allowing for heterogeneous time-variant causal effects. Employing a synthetic control method, we find that the passage of tax incentive legislation increased living unrelated kidney donation rates by 52 percent in New York relative to a comparable synthetic New York in the absence of legislation. It is possible that New York is unique, but our methodology does not allow us to measure accurately effects in other states. Copyright © 2015 Elsevier B.V. All rights reserved.

Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

ERIC Educational Resources Information Center

Torgerson, Carole J.

2009-01-01

The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…

Relation between burden of disease and randomised evidence in sub-Saharan Africa: survey of research.

PubMed

Isaakidis, Petros; Swingler, George H; Pienaar, Elizabeth; Volmink, Jimmy; Ioannidis, John P A

2002-03-23

To evaluate whether the amount of randomised clinical research on various medical conditions is related to the burden of disease and health needs of the local populations in sub-Saharan Africa. Construction and analysis of comprehensive database of randomised controlled trials in sub-Saharan Africa based on Medline, the Cochrane Controlled Trials Register, and several African databases. Sub-Saharan Africa. Number of trials and randomised subjects for each category of disease in the global burden of disease taxonomy; ratios of disability adjusted life years (DALYs) per amount of randomised evidence. 1179 eligible randomised controlled trials were identified. The number of trials published each year increased over time. Almost half of the trials (n=565) had been done in South Africa. There was relatively good correlation between the estimated burden of disease at year 2000 and the number of trials performed (r=0.53, P=0.024) and the number of participants randomised (r=0.68, P=0.002). However,some conditions-for example, injuries (over 20 000 DALYs per patient ever randomised)-were more neglected than others. Despite recent improvements, few clinical trials are done in sub-Saharan Africa. Clinical research in this part of the world should focus more evenly on the major contributors to burden of disease.

Organ donation in adults: a critical care perspective.

PubMed

Citerio, Giuseppe; Cypel, Marcelo; Dobb, Geoff J; Dominguez-Gil, Beatriz; Frontera, Jennifer A; Greer, David M; Manara, Alex R; Shemie, Sam D; Smith, Martin; Valenza, Franco; Wijdicks, Eelco F M

2016-03-01

The shortage of organs for transplantation is an important medical and societal problem because transplantation is often the best therapeutic option for end-stage organ failure. We review the potential deceased organ donation pathways in adult ICU practice, i.e. donation after brain death (DBD) and controlled donation after circulatory death (cDCD), which follows the planned withdrawal of life-sustaining treatments (WLST) and subsequent confirmation of death using cardiorespiratory criteria. Strategies in the ICU to increase the number of organs available for transplantation are discussed. These include timely identification of the potential organ donor, optimization of the brain-dead donor by aggressive management of the physiological consequence of brain death, implementation of cDCD protocols, and the potential for ex vivo perfusion techniques. Organ donation should be offered as a routine component of the end-of-life care plan of every patient dying in the ICU where appropriate, and intensivists are the key professional in this process.

Knowledge, attitude and practices of people towards voluntary blood donation in Uttarakhand.

PubMed

Agrawal, Amit; Tiwari, Aseem K; Ahuja, Alok; Kalra, Rakesh

2013-01-01

Blood transfusions form a crucial and irreplaceable part in the medical management of many diseases. The collection of blood from voluntary, non-remunerated blood donors from low risk populations is an important measure for ensuring the availability and safety of blood transfusion. In a state like Uttarakhand which is visited by lakhs of visitors during pilgrimage season and where natural calamities and accidents are very common, the availability of blood is of utmost importance. To find out knowledge, attitude and practices of people towards voluntary blood donation to comprehend the situation and find ways to enhance voluntary blood donation in the state of Uttarakhand. Multi stage methodology was designed to target population including general population, influencers (doctors) and supporting organizations (camp organizers, State AIDS Control Society Officials) who were subjected to in-depth interview using pre-structured questionnaires to assess knowledge/awareness about voluntary blood donation, factors preventing and source of knowledge about voluntary blood donation. The sample population consisted of mostly men (67%) in the age-group of 26-35 years. Requirement of blood and the measures to promote voluntary blood donation have a direct relationship with the total population and literacy level of the population. Awareness about blood donation, source of knowledge about blood donation, reasons for not donating blood are particularly stressed. With increase in educational level, the awareness level was also found to increase. While among illiterates 81 percent of the respondents knew about blood donation, among the post graduates the same ratio was found to be almost cent-percent. Among various reasons cited for not donating blood, lack of awareness being the most common reason. People gathered information about blood donation from several different sources with electronic media being the most prominent. This study illustrates how increasing awareness and marketing 'Voluntary blood donation' can enhance adequacy of blood needs of a state or for that matter the entire country. This study also underlines how different media, especially electronic media, can be used to propagate altruistic blood donation.

[Pre-randomisation in study designs: getting past the taboo].

PubMed

Schellings, R; Kessels, A G; Sturmans, F

2008-09-20

In October 2006 the Dutch Ministry of Health, Welfare and Sport announced that the use of pre-randomisation in study designs is admissible and not in conflict with the Dutch Medical Research in Human Subjects Act. With pre-randomisation, the conventional sequence of obtaining informed consent followed by randomisation is reversed. According to the original pre-randomisation design (Zelen design), participants are randomised before they are asked to consent; after randomisation, only participants in the experimental group are asked to consent to treatment and effect measurement. In the past, pre-randomisation has seldom been used, and when it was, it was often under the wrong circumstances. Awareness regarding the ethical, legal and methodological objections to pre-randomisation is increasing. About a decade ago, we illustrated the applicability and acceptability of pre-randomisation by means of a fictitious heroin provision trial. In general, pre-randomisation is justified if valid evaluation of the effects of an intervention is impossible using a conventional randomised design, e.g., if knowledge of the intervention may lead to non-compliance or drop-out in the control group, or when the intervention is an educational programme. Other requirements for pre-randomisation include the following: the study has a clinically relevant objective, it is likely that the study will lead to important new insights, the informed consent procedure bears no potential harm to participants, at least standard care is offered to participants in the control group, and the approval of an independent research ethics committee is obtained.

Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials.

PubMed

Cooper, Cindy L; Whitehead, Amy; Pottrill, Edward; Julious, Steven A; Walters, Stephen J

2018-04-01

External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland-Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was -4.4% with limits of agreement of -37.1% to 28.2%. Limits of agreement for randomisation rates were -47.8% to 77.5%. Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate.

Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials

PubMed Central

Whitehead, Amy; Pottrill, Edward; Julious, Steven A; Walters, Stephen J

2018-01-01

Background/aims: External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. Methods: Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland–Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. Results: Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was −4.4% with limits of agreement of −37.1% to 28.2%. Limits of agreement for randomisation rates were −47.8% to 77.5%. Conclusion: Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate. PMID:29361833

A causal model for longitudinal randomised trials with time-dependent non-compliance

PubMed Central

Becque, Taeko; White, Ian R; Haggard, Mark

2015-01-01

In the presence of non-compliance, conventional analysis by intention-to-treat provides an unbiased comparison of treatment policies but typically under-estimates treatment efficacy. With all-or-nothing compliance, efficacy may be specified as the complier-average causal effect (CACE), where compliers are those who receive intervention if and only if randomised to it. We extend the CACE approach to model longitudinal data with time-dependent non-compliance, focusing on the situation in which those randomised to control may receive treatment and allowing treatment effects to vary arbitrarily over time. Defining compliance type to be the time of surgical intervention if randomised to control, so that compliers are patients who would not have received treatment at all if they had been randomised to control, we construct a causal model for the multivariate outcome conditional on compliance type and randomised arm. This model is applied to the trial of alternative regimens for glue ear treatment evaluating surgical interventions in childhood ear disease, where outcomes are measured over five time points, and receipt of surgical intervention in the control arm may occur at any time. We fit the models using Markov chain Monte Carlo methods to obtain estimates of the CACE at successive times after receiving the intervention. In this trial, over a half of those randomised to control eventually receive intervention. We find that surgery is more beneficial than control at 6months, with a small but non-significant beneficial effect at 12months. © 2015 The Authors. Statistics in Medicine Published by JohnWiley & Sons Ltd. PMID:25778798

Applying the Health Belief Model and an Integrated Behavioral Model to Promote Breast Tissue Donation Among Asian Americans.

PubMed

Shafer, Autumn; Kaufhold, Kelly; Luo, Yunjuan

2018-07-01

An important part in the effort to prevent, treat, and cure breast cancer is research done with healthy breast tissue. The Susan G. Komen for the Cure Tissue Bank at Indiana University Simon Cancer Center (KTB) encourages women to donate a small amount of healthy breast tissue and then provides that tissue to researchers studying breast cancer. Although KTB has a large donor base, the volume of tissue samples from Asian women is low despite prior marketing efforts to encourage donation among this population. This study builds on prior work promoting breast cancer screenings among Asian women by applying constructs from the Health Belief Model (HBM) and the Integrated Behavioral Model (IBM) to investigate why Asian-American women are less inclined to donate their healthy breast tissue than non-Asian women and how this population may be motivated to donate in the future. A national online survey (N = 1,317) found Asian women had significantly lower perceived severity, some lower perceived benefits, and higher perceived barriers to tissue donation than non-Asian women under HBM and significantly lower injunctive norms supporting breast tissue donation, lower perceived behavioral control, and lower intentions to donate under IBM. This study also compares and discusses similarities and differences among East, Southeast, and South Asian women on these same constructs.

Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial.

PubMed

Hackshaw-McGeagh, Lucy; Lane, J Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M; Martin, Richard

2016-03-07

A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with localised prostate cancer and eligible for radical prostatectomy to interventions that modify nutrition and physical activity. The primary outcomes are randomisation rates and adherence to the interventions at 6 months following randomisation. The secondary outcomes are intervention tolerability, trial retention, change in prostate specific antigen level, change in diet, change in general physical activity levels, insulin-like growth factor levels, and a range of related outcomes, including quality of life measures. The trial is factorial, randomising men to both a physical activity (brisk walking or control) and nutritional (lycopene supplementation or increased fruit and vegetables with reduced dairy consumption or control) intervention. The trial has two phases: men are enrolled into a cohort study prior to radical prostatectomy, and then consented after radical prostatectomy into a randomised controlled trial. Data are collected at four time points (cohort baseline, true trial baseline and 3 and 6 months post-randomisation). The Prostate Cancer: Evidence of Exercise and Nutrition Trial aims to determine whether men with localised prostate cancer who are scheduled for radical prostatectomy can be recruited into a cohort and subsequently randomised to a 6-month nutrition and physical activity intervention trial. If successful, this feasibility trial will inform a larger trial to investigate whether this population will gain clinical benefit from long-term nutritional and physical activity interventions post-surgery. Prostate Cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) is registered on the ISRCTN registry, ref number ISRCTN99048944. Date of registration 17 November 2014.

Beliefs underlying blood donors' intentions to donate during two phases of an avian influenza outbreak.

PubMed

Masser, Barbara M; White, Katherine M; Hamilton, Kyra; McKimmie, Blake M

2012-02-01

Using a Theory of Planned Behavior (TPB) framework the current study explored the beliefs of current blood donors (N=172) about donating during a low and high-risk phase of a potential avian influenza outbreak. While the majority of behavioral, normative, and control beliefs identified in preliminary research differed as a function of donors' intentions to donate during both phases of an avian influenza outbreak, regression analyses suggested that the targeting of different specific beliefs during each phase of an outbreak would yield most benefit in bolstering donors' intentions to remain donating. The findings provide insight in how to best motivate donors in different phases of an avian influenza outbreak. Copyright © 2011 Elsevier Ltd. All rights reserved.

If you needed an organ transplant would you have one? The effect of reciprocity priming and mode of delivery on organ donor registration intentions and behaviour.

PubMed

O'Carroll, Ronan E; Haddow, Lorna; Foley, Laura; Quigley, Jody

2017-09-01

There are approximately 6,500 people on the UK national transplant waiting list, around 400 of whom die every year. Only 35% of the UK population are currently on the organ donation register. We report two studies examining whether a reciprocity prime, in which participants were asked whether they would accept a donated organ, increased organ donation intentions and behaviour. Between-participants, randomized controlled design. In two studies, participants who were not currently registered organ donors took part either face-to-face or online and were randomly allocated to a reciprocity prime or control condition. Following the manipulation, they were asked to indicate, on either a paper or online questionnaire, their intention to join the organ donor register. Study 2 was similar to Study 1 but with the addition that after reporting intention, participants were then offered an organ donation information leaflet or the opportunity to click a link for further information (proxy behavioural measure). In both studies, reciprocity primed participants reported greater intentions to register than controls. However, in Study 2, no effect on donation behaviour was found. Reciprocal altruism may be a useful tool in increasing intentions to join the organ donor register. Further evaluation is required to determine whether this increase in intention can be translated into organ donation behaviour. Statement of contribution What was already known? Demand for organs in the United Kingdom far outstrips supply, so finding strategies to increase registration on the organ donor register could save hundreds of lives per year. Despite the majority of people in the United Kingdom agreeing that organ donation is a good thing, most people do not register as donors. A limited amount of evidence of the impact of perceived reciprocity suggests that encouraging people to consider themselves as recipients and priming ideas of shared responsibility may increase the likelihood of their subsequent willingness to register. What does this study add? Novel evidence that employing a simple reciprocity prime increases organ donor registration intentions. Replication of findings across two separate studies. Novel examination of the impact of mode of delivery of messages to encourage organ donation. A basis for further research into the translation of intentions into organ donor registration behaviour. © 2017 The British Psychological Society.

Effectiveness of strategies incorporating training and support of traditional birth attendants on perinatal and maternal mortality: meta-analysis

PubMed Central

Wilson, Amie; Gallos, Ioannis D; Plana, Nieves; Lissauer, David; Khan, Khalid S; Zamora, Javier; MacArthur, Christine

2011-01-01

Objective To assess the effectiveness of strategies incorporating training and support of traditional birth attendants on the outcomes of perinatal, neonatal, and maternal death in developing countries. Design Systematic review with meta-analysis. Data sources Medline, Embase, the Allied and Complementary Medicine database, British Nursing Index, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, BioMed Central, PsycINFO, Latin American and Caribbean Health Sciences Literature database, African Index Medicus, Web of Science, Reproductive Health Library, and Science Citation Index (from inception to April 2011), without language restrictions. Search terms were “birth attend*”, “traditional midwife”, “lay birth attendant”, “dais”, and “comadronas”. Review methods We selected randomised and non-randomised controlled studies with outcomes of perinatal, neonatal, and maternal mortality. Two independent reviewers undertook data extraction. We pooled relative risks separately for the randomised and non-randomised controlled studies, using a random effects model. Results We identified six cluster randomised controlled trials (n=138 549) and seven non-randomised controlled studies (n=72 225) that investigated strategies incorporating training and support of traditional birth attendants. All six randomised controlled trials found a reduction in adverse perinatal outcomes; our meta-analysis showed significant reductions in perinatal death (relative risk 0.76, 95% confidence interval 0.64 to 0.88, P<0.001; number needed to treat 35, 24 to 70) and neonatal death (0.79, 0.69 to 0.88, P<0.001; 98, 66 to 170). Meta-analysis of the non-randomised studies also showed a significant reduction in perinatal mortality (0.70, 0.57 to 0.84, p<0.001; 48, 32 to 96) and neonatal mortality (0.61, 0.48 to 0.75, P<0.001; 96, 65 to 168). Six studies reported on maternal mortality and our meta-analysis showed a non-significant reduction (three randomised trials, relative risk 0.79, 0.53 to 1.05, P=0.12; three non-randomised studies, 0.80, 0.44 to 1.15, P=0.26). Conclusion Perinatal and neonatal deaths are significantly reduced with strategies incorporating training and support of traditional birth attendants. PMID:22134967

Effectiveness of strategies incorporating training and support of traditional birth attendants on perinatal and maternal mortality: meta-analysis.

PubMed

Wilson, Amie; Gallos, Ioannis D; Plana, Nieves; Lissauer, David; Khan, Khalid S; Zamora, Javier; MacArthur, Christine; Coomarasamy, Arri

2011-12-01

To assess the effectiveness of strategies incorporating training and support of traditional birth attendants on the outcomes of perinatal, neonatal, and maternal death in developing countries. Systematic review with meta-analysis. Medline, Embase, the Allied and Complementary Medicine database, British Nursing Index, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, BioMed Central, PsycINFO, Latin American and Caribbean Health Sciences Literature database, African Index Medicus, Web of Science, Reproductive Health Library, and Science Citation Index (from inception to April 2011), without language restrictions. Search terms were "birth attend*", "traditional midwife", "lay birth attendant", "dais", and "comadronas". Review methods We selected randomised and non-randomised controlled studies with outcomes of perinatal, neonatal, and maternal mortality. Two independent reviewers undertook data extraction. We pooled relative risks separately for the randomised and non-randomised controlled studies, using a random effects model. We identified six cluster randomised controlled trials (n=138 549) and seven non-randomised controlled studies (n=72 225) that investigated strategies incorporating training and support of traditional birth attendants. All six randomised controlled trials found a reduction in adverse perinatal outcomes; our meta-analysis showed significant reductions in perinatal death (relative risk 0.76, 95% confidence interval 0.64 to 0.88, P<0.001; number needed to treat 35, 24 to 70) and neonatal death (0.79, 0.69 to 0.88, P<0.001; 98, 66 to 170). Meta-analysis of the non-randomised studies also showed a significant reduction in perinatal mortality (0.70, 0.57 to 0.84, p<0.001; 48, 32 to 96) and neonatal mortality (0.61, 0.48 to 0.75, P<0.001; 96, 65 to 168). Six studies reported on maternal mortality and our meta-analysis showed a non-significant reduction (three randomised trials, relative risk 0.79, 0.53 to 1.05, P=0.12; three non-randomised studies, 0.80, 0.44 to 1.15, P=0.26). Perinatal and neonatal deaths are significantly reduced with strategies incorporating training and support of traditional birth attendants.

Social influences on corporate political donations in Britain.

PubMed

Bond, Matthew

2004-03-01

It is argued that institutional features of the British state create collective action problems for the mobilization of corporations as donors to the Conservative Party. Social factors are necessary for overcoming these problems. Using social network analyses, the effect that interlocking directorates have on 250 large British corporations' decisions to donate are analysed. Instead of the central mobilizing factor being diffuse inner circle mechanisms positively influencing the decision to make a donation, the results show that more particularistic mechanisms such as information bias and control are equally important.

Progress Report on Neglected Tropical Disease Drug Donation Programs.

PubMed

Cohen, Joshua P; Silva, Lisseth; Cohen, Alisa; Awatin, Josephine; Sturgeon, Robert

2016-05-01

Neglected tropical diseases (NTDs) impose a significant burden on public health, particularly in developing nations. Many can be treated cost-effectively with drugs donated or offered at or below marginal cost. In 2012, the World Health Organization published an NTD roadmap that outlined a strategy for the prevention, control, and eradication of 17 NTDs by 2020. Inspired by this roadmap, executives from 13 pharmaceutical companies, government agencies, and other interested parties signed the London Declaration on Neglected Tropical Diseases in January 2012. In this paper, we will assess progress in meeting commitments on drug donations laid out in the London Declaration. We conducted Medline and LexisNexis searches of peer-reviewed publications and trade journals, as well as product development partnership and government reports. Subsequently, we designed a survey instrument and surveyed 10 company signatories (companies with drug donation programs) to the London Declaration to determine current donations and pledges. Nine of 10 companies with donation programs responded to the survey. The respondents reported substantial progress in meeting the goals laid out in the London Declaration. Survey respondents maintained 17 drug donation programs across 10 disease categories. In 2014, companies donated >1 billion treatments, with a dollar value of nearly $1.5 billion. However, not all donated products were distributed to patients in need. In addition, 4 of the 17 programs were slated to end before 2020, three of the 17 programs did not report explicit program objectives, and 7 of 17 did not measure the impact of programs in terms of numbers of patients treated. None of our survey respondents reported on whether the programs were leading to a reduction in disease prevalence. Donations are a necessary but insufficient condition for patient access to neglected disease drugs. Additional resources must be allocated to ensure delivery of donated products to patients. In addition, drug donation programs should provide explicit descriptions of program objectives, measurements of the impacts of their programs, and extension of all donation commitments through 2020. To achieve this, multiple stakeholders with a vested interest in reducing the burden of neglected diseases must collaborate in a multipronged approach toward NTD elimination. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Knowledge, attitude and practices of people towards voluntary blood donation in Uttarakhand

PubMed Central

Agrawal, Amit; Tiwari, Aseem K.; Ahuja, Alok; Kalra, Rakesh

2013-01-01

Introduction: Blood transfusions form a crucial and irreplaceable part in the medical management of many diseases. The collection of blood from voluntary, non-remunerated blood donors from low risk populations is an important measure for ensuring the availability and safety of blood transfusion. In a state like Uttarakhand which is visited by lakhs of visitors during pilgrimage season and where natural calamities and accidents are very common, the availability of blood is of utmost importance. Aim: To find out knowledge, attitude and practices of people towards voluntary blood donation to comprehend the situation and find ways to enhance voluntary blood donation in the state of Uttarakhand. Materials and Methods: Multi stage methodology was designed to target population including general population, influencers (doctors) and supporting organizations (camp organizers, State AIDS Control Society Officials) who were subjected to in-depth interview using pre-structured questionnaires to assess knowledge/awareness about voluntary blood donation, factors preventing and source of knowledge about voluntary blood donation. Result: The sample population consisted of mostly men (67%) in the age-group of 26-35 years. Requirement of blood and the measures to promote voluntary blood donation have a direct relationship with the total population and literacy level of the population. Awareness about blood donation, source of knowledge about blood donation, reasons for not donating blood are particularly stressed. With increase in educational level, the awareness level was also found to increase. While among illiterates 81 percent of the respondents knew about blood donation, among the post graduates the same ratio was found to be almost cent-percent. Among various reasons cited for not donating blood, lack of awareness being the most common reason. People gathered information about blood donation from several different sources with electronic media being the most prominent. Conclusion: This study illustrates how increasing awareness and marketing ‘Voluntary blood donation’ can enhance adequacy of blood needs of a state or for that matter the entire country. This study also underlines how different media, especially electronic media, can be used to propagate altruistic blood donation. PMID:23559768

Measuring Critical Care Providers' Attitudes About Controlled Donation After Circulatory Death.

PubMed

Rodrigue, James R; Luskin, Richard; Nelson, Helen; Glazier, Alexandra; Henderson, Galen V; Delmonico, Francis L

2018-06-01

Unfavorable attitudes and insufficient knowledge about donation after cardiac death among critical care providers can have important consequences for the appropriate identification of potential donors, consistent implementation of donation after cardiac death policies, and relative strength of support for this type of donation. The lack of reliable and valid assessment measures has hampered research to capture providers' attitudes. Design and Research Aims: Using stakeholder engagement and an iterative process, we developed a questionnaire to measure attitudes of donation after cardiac death in critical care providers (n = 112) and examined its psychometric properties. Exploratory factor analysis, internal consistency, and validity analyses were conducted to examine the measure. A 34-item questionnaire consisting of 4 factors (Personal Comfort, Process Satisfaction, Family Comfort, and System Trust) provided the most parsimonious fit. Internal consistency was acceptable for each of the subscales and the total questionnaire (Cronbach α > .70). A strong association between more favorable attitudes overall and knowledge ( r = .43, P < .001) provides evidence of convergent validity. Multivariable regression analyses showed that white race ( P = .002) and more experience with donation after cardiac death ( P < .001) were significant predictors of more favorable attitudes. Study findings support the utility, reliability, and validity of a questionnaire for measuring attitudes in critical care providers and for isolating targets for additional education on donation after cardiac death.

Understanding and Communicating Medical Risks for Living Kidney Donors: A Matter of Perspective

PubMed Central

Lentine, Krista L.

2017-01-01

Communicating the current knowledge of medical outcomes after live kidney donation necessary to support donor candidates in well informed decision-making requires grounding in perspectives of comparison. Baseline risk (without donating), risk attributable to donation, and absolute risk (after donating) need to be considered. Severe perioperative complications and death are rare, but vary by demographic, clinical, and procedure factors. Innovative capture of “healthy” controls designed to simulate donor selection processes has identified higher risk of ESRD attributable to donation in two studies; importantly, however, the absolute 15-year ESRD incidence in donors remains very low (0.3%). In the first decade after donation, the risk of all-cause mortality and cardiovascular events is no higher than in healthy nondonors. Pregnancies in donors may incur attributable risk of gestational hypertension or preeclampsia (11% versus 5% incidence in one study). A modest rise in uric acid levels beginning early after donation, and a small (1.4%) increase in the 8-year incidence of gout, have also been reported in comparisons to healthy nondonors. As in the general population, postdonation outcomes vary by race, sex, and age. Efforts to improve the counseling and selection of living donors should focus on developing tools for tailored risk prediction according to donor characteristics, and ideally, compared with similar healthy nondonors. PMID:27591246

Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study

PubMed Central

van de Hei, Susanne; McKinstry, Steven; Bardsley, George; Weatherall, Mark; Beasley, Richard; Fingleton, James

2018-01-01

Objective To determine the feasibility of a randomised controlled trial (RCT) of rhinothermy for the common cold. Design Open label, randomised, controlled feasibility study. Setting Single-centre research institute in New Zealand recruiting participants from the community. Participants 30 adult participants with symptoms of a common cold, presenting within 48 hours of the onset of symptoms. Interventions Participants were randomly assigned 2:1 to receive either 35 L/min of 100% humidified air at 41°C via high flow nasal cannulae, 2 hours per day for up to 5 days (rhinothermy), or vitamin C 250 mg daily for 5 days (control). Primary and secondary outcome measures The primary outcome was the proportion of screened candidates who were randomised. Secondary outcomes included: proportion of randomised participants who completed the study; modified Jackson scores from randomisation to 10 days after initiation of randomised regimen; time until feeling ‘a lot better’ compared with study entry; time until resolution of symptoms or symptom score at 10 days postrandomisation; proportion of organisms identified by PCR analysis of nasal swabs taken at baseline; the patterns of use of the rhinothermy device; estimated adherence of the control group; and rhinothermy device tolerability. Results In all 30/79 (38%, 95% CI 27% to 50%) of potential participants screened for eligibility were randomised. Rhinothermy was well tolerated, and all randomised participants completed the study (100%, 95% CI 88% to 100%). The reduction from baseline in the modified Jackson score was greater with rhinothermy compared with control at days 2, 3, 4, 5 and 6, with the maximum difference at day 4 (−6.4, 95% CI −9.4 to −3.3). The substantial clinical benefit threshold for modified Jackson score was a 5-unit change. Conclusions This study shows that an RCT of rhinothermy compared with low-dose vitamin C in the treatment of the common cold is feasible. Trial registration number ACTRN12616000470493; Results. PMID:29593018

Understanding the underlying motives and intention among Indian blood donors towards voluntary blood donation: A cross-sectional study.

PubMed

Saha, S; Chandra, B

2018-05-01

The present study aims to fill the gap in the literature by conducting a comprehensive research on Indian donor's intention towards voluntary blood donation in India. The study attempts to conceptualize and validate an integrative framework incorporating voluntary function inventory (VFI) in the theory of planned behaviour (TPB) model with the purpose tomeasure the voluntary blood donation intention. Structural equation modeling (SEM) has been used to rigorously test the hypothesized interrelationships among the underlying motives influencing voluntary blood donation intention. A self-administered questionnaire was used to collect data from a sample of respondents selected conveniently from selct locations in India. Total 450 completed questionnaires were received out of 1000 distributed. The study develops a final conceptual framework that determines the drivers of blood donor's intention towards voluntary donation. The components of theory of planned behavior (TPB) model which include 'attitude', 'subjective norms' (SN), and 'perceived behavioral control' (PBC) along with modified volunteer functions namely 'value', 'social', 'career' and 'enhancement' were found significantly explaining the donation intention in the model. The model achieves robustness with respect to predicting Indian donor's intention towards the voluntary donation of blood. The proposed model in this study advances the theory and research on thevolunteering motives towards blood donation. The study would provide a comprehensiveunderstanding of donors' intention to the practitioners, policy makers and Non-Government Organization (NGO), helping them to frame a calibrated strategydirected towards facilitating healthy blood donation practices. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

The Public Face of Transplantation: The Potential of Education to Expand the Face Donor Pool.

PubMed

Plana, Natalie M; Kimberly, Laura L; Parent, Brendan; Khouri, Kimberly S; Diaz-Siso, J Rodrigo; Fryml, Elise M; Motosko, Catherine C; Ceradini, Daniel J; Caplan, Arthur; Rodriguez, Eduardo D

2018-01-01

Despite the growing success of facial transplantation, organ donor shortages remain challenging. Educational health campaigns can effectively inform the general public and institute behavioral modifications. A brief educational introduction to facial transplantation may positively influence the public's position on facial donation. The authors anonymously surveyed 300 participants, gathering basic demographic information, donor registration status, awareness of facial transplantation, and willingness to donate solid organs and facial allografts. Two-hundred of these participants were presented an educational video and subsequently resurveyed on facial donation. Factorial parametric analyses were performed to compare exposure responses before and after watching video exposure. Among participants completing the survey alone (control group), 49 percent were registered donors, 78 percent reported willingness to donate solid organs, and 52 percent reported willingness to donate facial allograft. Of participants who watched the video (video group) 52 percent were registered; 69 and 51 percent were willing to donate solid organs and face, respectively. Following educational intervention, 69 percent of participants in the video group reported willingness to donate facial tissue, an 18 percent increase (p < 0.05), that equated to those willing to donate solid organs. The greatest increase was observed among younger participants (23 percent); women (22 percent); Jewish (22 percent), Catholic (22 percent), and black/African American (25 percent) participants; and respondents holding a higher degree. No significant differences according to gender or ethnicity were observed. Educational interventions hold much promise for increasing the general public's awareness of facial transplantation and willingness to participate in donation of facial allografts.

Is inertial flywheel resistance training superior to gravity-dependent resistance training in improving muscle strength? A systematic review with meta-analyses.

PubMed

Vicens-Bordas, J; Esteve, E; Fort-Vanmeerhaeghe, A; Bandholm, T; Thorborg, K

2018-01-01

The primary aim of this systematic review was to determine if inertial flywheel resistance training is superior to gravity-dependent resistance training in improving muscle strength. The secondary aim was to determine whether inertial flywheel resistance training is superior to gravity-dependent resistance training in improving other muscular adaptations. A systematic review with meta-analyses of randomised and non-randomised controlled trials. We searched MEDLINE, Scopus, SPORTDiscus, Web of Science and Cochrane Central Register of Controlled Trials with no publication date restrictions until November 2016. We performed meta-analyses on randomised and non-randomised controlled trials to determine the standardized mean difference between the effects of inertial flywheel and gravity-dependent resistance training on muscle strength. A total of 76 and 71 participants were included in the primary and secondary analyses, respectively. After systematic review, we included three randomised and four non-randomised controlled trials. In the primary analysis for the primary outcome muscle strength, the pooled results from randomised controlled trials showed no difference (SMD=-0.05; 95%CI -0.51 to 0.40; p=0.82; I 2 =0%). In the secondary analyses of the primary outcome, the pooled results from non-randomised controlled trials showed no difference (SMD=0.02; 95%CI -0.45 to 0.49; p=0.93; I 2 =0%; and SMD=0.03; 95%CI -0.43 to 0.50; p=0.88; I 2 =0%). Meta-analysis on secondary outcomes could not be performed. Based on the available data, inertial flywheel resistance training was not superior to gravity-dependent resistance training in enhancing muscle strength. Data for other strength variables and other muscular adaptations was insufficient to draw firm conclusions from. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Impact of organ donation education on US undergraduate nursing students.

PubMed

Kurz, Jane McCausland

2014-06-01

Experts advocate educational programs addressing misinformation regarding donation decisions to increase the potential donor pool. However, few researchers have measured outcomes with nursing students. The purpose of this study was to evaluate the impact of an educational intervention on nursing students' knowledge, attitudes, registering as an organ donor, and family discussions. This quasi-experimental study used a pretest-posttest design with a control group. The research group consisted of 42 volunteers and the control group consisted of 73 volunteers. The written survey included 15 true-false knowledge items and 8 Likert items asking about attitude toward donation, registering as an organ donor, and family discussion. Normally distributed data showed no significant differences between groups on the pretest. The research group had no change in knowledge level 3 months later, but the control group had a significantly decreased knowledge level at that point. More members of the research group than the control group registered as organ donors after the intervention (χ2 = 4.5, P= .03). The control group had no change in registering as an organ donor between the pretest and posttest. Family discussions did not differ significantly from pretest to posttest in either group. One lecture/laboratory experience did make a difference in registering as an organ donor but not in discussing the decision with family members. Students can learn about organ donation from more than one specific class. Recommendations for educators and future research are provided.

Public views on the donation and use of human biological samples in biomedical research: a mixed methods study

PubMed Central

Lewis, Celine; Clotworthy, Margaret; Hilton, Shona; Magee, Caroline; Robertson, Mark J; Stubbins, Lesley J; Corfield, Julie

2013-01-01

Objective A mixed methods study exploring the UK general public's willingness to donate human biosamples (HBSs) for biomedical research. Setting Cross-sectional focus groups followed by an online survey. Participants Twelve focus groups (81 participants) selectively sampled to reflect a range of demographic groups; 1110 survey responders recruited through a stratified sampling method with quotas set on sex, age, geographical location, socioeconomic group and ethnicity. Main outcome measures (1) Identify participants’ willingness to donate HBSs for biomedical research, (2) explore acceptability towards donating different types of HBSs in various settings and (3) explore preferences regarding use and access to HBSs. Results 87% of survey participants thought donation of HBSs was important and 75% wanted to be asked to donate in general. Responders who self-reported having some or good knowledge of the medical research process were significantly more likely to want to donate (p<0.001). Reasons why focus group participants saw donation as important included: it was a good way of reciprocating for the medical treatment received; it was an important way of developing drugs and treatments; residual tissue would otherwise go to waste and they or their family members might benefit. The most controversial types of HBSs to donate included: brain post mortem (29% would donate), eyes post mortem (35%), embryos (44%), spare eggs (48%) and sperm (58%). Regarding the use of samples, there were concerns over animal research (34%), research conducted outside the UK (35%), and research conducted by pharmaceutical companies (56%), although education and discussion were found to alleviate such concerns. Conclusions There is a high level of public support and willingness to donate HBSs for biomedical research. Underlying concerns exist regarding the use of certain types of HBSs and conditions under which they are used. Improved education and more controlled forms of consent for sensitive samples may mitigate such concerns. PMID:23929915

Understanding barriers and outcomes of unspecified (non-directed altruistic) kidney donation from both professional’s and patient’s perspectives: research protocol for a national multicentre mixed-methods prospective cohort study

PubMed Central

Gare, Rebecca; Gogalniceanu, Petrut; Maple, Hannah; Burnapp, Lisa; Clarke, Alexis; Williams, Lynsey; Norton, Sam; Chilcot, Joseph; Gibbs, Paul; Mitchell, Annie; McCrone, Paul; Draper, Heather; Mamode, Nizam

2017-01-01

Introduction Living donation accounts for over one-third of all kidney transplants taking place in the UK. 1 The concept of anonymously donating a kidney to a stranger (non-directed altruistic or unspecified kidney donation (UKD)) remains uncomfortable for some clinicians, principally due to concerns about the motivations and long-term physical and psychological outcomes in this donor group. Aims The research programme aims to provide a comprehensive assessment of the unspecified donor programme in the UK. It aims to identify reasons for variations in practice across centres, explore outcomes for donors and ascertain barriers and facilitators to UKD, as well as assess the economic implications of unspecified donation. Methods The research programme will adopt a mixed-methods approach to assessing UKD nationally using focus groups, interviews and questionnaires. Two study populations will be investigated. The first will include transplant professionals involved in unspecified kidney donation. The second will include a 5-year prospective cohort of individuals who present to any of the 23 UK transplant centres as a potential unspecified living kidney donor. Physical and psychological outcomes will be followed up to 1 year following donation or withdrawal from the donation process. A matched sample of specified donors (those donating to someone they know) will be recruited as a control group. Further qualitative work consisting of interviews will be performed on a purposive sample of unspecified donors from both groups (those who do and do not donate). Dissemination The findings will be reported to NHS Blood and Transplant and the British Transplant Society with a view to developing national guidelines and a protocol for the management of those presenting for unspecified donation. Trial registration number ISRCTN23895878, Pre-results. PMID:28939572

Understanding barriers and outcomes of unspecified (non-directed altruistic) kidney donation from both professional's and patient's perspectives: research protocol for a national multicentre mixed-methods prospective cohort study.

PubMed

Gare, Rebecca; Gogalniceanu, Petrut; Maple, Hannah; Burnapp, Lisa; Clarke, Alexis; Williams, Lynsey; Norton, Sam; Chilcot, Joseph; Gibbs, Paul; Mitchell, Annie; McCrone, Paul; Draper, Heather; Mamode, Nizam

2017-09-21

Living donation accounts for over one-third of all kidney transplants taking place in the UK. 1 The concept of anonymously donating a kidney to a stranger (non-directed altruistic or unspecified kidney donation (UKD)) remains uncomfortable for some clinicians, principally due to concerns about the motivations and long-term physical and psychological outcomes in this donor group. The research programme aims to provide a comprehensive assessment of the unspecified donor programme in the UK. It aims to identify reasons for variations in practice across centres, explore outcomes for donors and ascertain barriers and facilitators to UKD, as well as assess the economic implications of unspecified donation. The research programme will adopt a mixed-methods approach to assessing UKD nationally using focus groups, interviews and questionnaires. Two study populations will be investigated. The first will include transplant professionals involved in unspecified kidney donation. The second will include a 5-year prospective cohort of individuals who present to any of the 23 UK transplant centres as a potential unspecified living kidney donor. Physical and psychological outcomes will be followed up to 1 year following donation or withdrawal from the donation process. A matched sample of specified donors (those donating to someone they know) will be recruited as a control group. Further qualitative work consisting of interviews will be performed on a purposive sample of unspecified donors from both groups (those who do and do not donate). The findings will be reported to NHS Blood and Transplant and the British Transplant Society with a view to developing national guidelines and a protocol for the management of those presenting for unspecified donation. ISRCTN23895878, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Aviation-related cardiorespiratory effects of blood donation in female private pilots.

DOT National Transportation Integrated Search

1984-03-01

Ten healthy female pilots, 20-49 years old and weighing more than 110 pounds were tested for tolerances to hypoxia orthostatic stress, and physical work at 1 and 3 d after donating about 450 mL of blood on one occasion, and 6 mL (sham control) on a s...

A high-potency, single-donor cryoprecipitate of known factor VIII content dispensed in vials.

PubMed

McLeod, B C; Sassetti, R J; Cole, E R; Scott, J P

1987-01-01

Current factor VIII products expose recipients to many donors and hence to a high risk of acquiring blood-borne infections. Plasma-exchange donation of cryoprecipitate can reduce donor exposure by repeatedly obtaining large yields of factor VIII from individual donors. In this study, donor factor VIII levels were stimulated with desmopressin before donation. Mean yield per donation increased from 1399 +/- 425 IU in controls to 3818 +/- 1350 IU in stimulated donations (p less than 0.001), and mean factor VIII concentration in the cryoprecipitate increased from 8.2 +/- 3 IU/mL to 24 +/- 12 IU/mL (p less than 0.001). A new packaging system dispenses assayed aliquots of stimulated cryoprecipitate in plastic vials. The direct cost of production for this material is $.065 per unit. The cryoprecipitate is hemostatically active and convenient to use, and the aggregate yields from sequential donations by stimulated persons are high enough to allow long-term, single-donor support of many adults with hemophilia.

Iron supplementation and 2-unit red blood cell apheresis: a randomized, double-blind, placebo-controlled study.

PubMed

Radtke, Hartmut; Mayer, Beate; Röcker, Lothar; Salama, Abdulgabar; Kiesewetter, Holger

2004-10-01

The benefits of 2-unit red blood cell (RBC) apheresis are evident, but iron depletion may be a limiting factor in using this technology. Regular iron supplementation may allow a better utilization of this technique. In this study, 260 regular blood donors donated 2-unit RBCs on each of a total of seven visits at intervals of 8 to 10 weeks. The volunteers were randomly assigned to receive 100 mg of iron(II) or placebo daily. Group A received iron capsules after the first three donations, and Group B after the second three donations, respectively. Hemoglobin, serum ferritin, and serum iron were measured before each donation. Mean serum ferritin concentration decreased after each donation in the placebo phase of both treatment groups, but it remained largely constant during the iron phase in Group A, and even increased during the iron phase in Group B. Regular iron supplementation prevents iron depletion in the majority of donors after 2-unit RBC apheresis within an 8- to 10-week period.

Anticonvulsants for preventing seizures in patients with chronic subdural haematoma.

PubMed

Ratilal, Bernardo O; Pappamikail, Lia; Costa, João; Sampaio, Cristina

2013-06-06

Anticonvulsant therapy is sometimes used prophylactically in patients with chronic subdural haematoma, although the benefit is unclear. To assess the effects of prophylactic anticonvulsants in patients with chronic subdural haematoma, in both the pre- and post-operative periods. We searched the Cochrane Injuries Group's Specialised Register, CENTRAL (The Cochrane Library), MEDLINE (OvidSP), EMBASE (OvidSP), PubMed, LILACS, and the databases clinicaltrials.gov, the WHO International Clinical Trials Registry Platform, and Current Controlled Trials. The search was through 27th March 2013. Randomised controlled trials comparing any anticonvulsant versus placebo or no intervention. Three authors screened the search results to identify relevant studies. No studies met the inclusion criteria for the review. No randomised controlled trials were identified. No formal recommendations can be made about the use of prophylactic anticonvulsants in patients with chronic subdural haematoma based on the literature currently available. There are no randomised controlled trials on this topic, and non-controlled studies have conflicting results. There is an urgent need for well-designed randomised controlled trials.

[Results of mycologic studies of donated breast milk].

PubMed

Blaschke-Hellmessen, R; Henker, J; Futschik, M

1991-03-01

From 1968 to 1989 altogether 37,000 specimens of donated and collected mother's milk were mycologically examined by means of a liquid medium (twofold concentrated Raulin solution). The yearly incidence of Candida albicans varied between 8.5 and 5.2%. 25% respectively 14.8% of the donors (n = 60 respectively 813) had delivered milk to the human milk bank which was contaminated by Candida albicans. The mother's milk was primarily contaminated by the donor's own suckling baby. 92.3% of these infants were infected with Candida albicans in the mouth and/or rectum and/or on the skin. Candida albicans was also detected in 46.2% on the nipples of the mothers. It is recommended to transport donated mother's milk at temperatures of 4-8 degrees C and to store the milk at -20 degrees C until the mycological examination is finished to exclude samples contaminated by Candida albicans. Judging our experience donated human milk to be fed in raw state should be regularly controlled mycologically. If the donated milk contains Candida albicans, the donation of milk should be interrupted and an antifungal treatment of the donor and her baby should be performed.

Factors influencing blood donations and the rational use of blood.

PubMed

Sharma, Rajeev; Madan, Nidhi; Venkatesh, S; Ichhpujani, R L; Lal, S

2010-09-01

A multicentric quasi-experimental study was conducted in Delhi, from March 2007 to September 2007, on i) the factors which stimulate the donors to donate blood, ii) major barriers and myths associated with blood donation and iii) clinicians perception of the rational use of blood. The study design included a face-to-face survey, with a pre-tested questionnaire paper in two leading blood banks of Delhi and by relevant interviewers from the community and medical fraternity. The sample size was 240-blood donors from two different blood banks and the control group included 100 potential donors from community and 50 clinicians from various hospitals. The data generated was analyzed using excel sheet and Epi-Info software. The study revealed the factors which influence the blood donation included replacement credit and family/peer pressure. Regarding myths and barriers, among potential donors, about a quarter of them felt that it is time consuming, and 20% felt it could lead to sexual impairment or is not rewarding. A total of 10% were not aware about the blood donation while 15% said that donation time was inconvenient. Of the 50 clinicians, a quarter of them were not aware of the rational use of blood.

DCD lung donation: donor criteria, procedural criteria, pulmonary graft function validation, and preservation.

PubMed

Erasmus, Michiel E; van Raemdonck, Dirk; Akhtar, Mohammed Zeeshan; Neyrinck, Arne; de Antonio, David Gomez; Varela, Andreas; Dark, John

2016-07-01

In an era where there is a shortage of lungs for transplantation is increased utilization of lungs from donation after circulatory death (DCD) donors. We review the reports of 11 controlled and 1 uncontrolled DCD programs focusing on donor criteria, procedural criteria, graft assessment, and preservation techniques including the use of ex vivo lung perfusion. We have formulated conclusions and recommendations for each of these areas, which were presented at the 6th International Conference on Organ Donation. A table of recommendations, the grade of recommendations, and references are provided. © 2015 Steunstichting ESOT.

Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial).

PubMed

Fetterplace, Kate; Deane, Adam M; Tierney, Audrey; Beach, Lisa; Knight, Laura D; Rechnitzer, Thomas; Forsyth, Adrienne; Mourtzakis, Marina; Presneill, Jeffrey; MacIsaac, Christopher

2018-01-01

Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes. This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU) will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein) or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein). The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT) from baseline (prior to randomisation) to ICU discharge and other nutritional and patient-centred outcomes. This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12615000876594 UTN: U1111-1172-8563.

[The contribution of persuasion social psychology to the retention of donors: the impact of labelling the previous donation].

PubMed

Callé, N; Plainfossé, C; Georget, P; Sénémeaud, C; Rasonglès, P

2011-12-01

The supply of blood cell products requires from the National French Blood Institute (Établissement Français du Sang - EFS) to rely upon regular blood donors. Contact with donors, tailored to individuals as much as possible, helps them to donate on a regular basis. Within the context of a research program conducted with the Psychology Department of the Université de Caen Basse-Normandie, persuasive theoretical models from social psychology have been tested. These models allow adapting messages according to the motivation of donors. The content is centred on the previous donation, differently labelled according to two types of labelling: functional labelling and social labelling. Functional labelling points out the efficiency of what "has been done" (the previous blood donation), whereas social labelling emphasizes the social value of the individual. Different types of mailing invitations have been sent to 1917 donors from the Normandy database, invited to three different blood collections. Every experimental letter worked better than the standard EFS letter (which was used as the "control" letter) in terms of effective blood donation after reception of the letter. Some of the letters are more efficient in motivating donors than other ones. The letters labelling the previous blood donation as functional (efficiency of the donation) appeared more efficient than those with social label (social value) in whichever motivation induced. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive-behavioural therapy.

PubMed

Langdon, Peter E; Murphy, Glynis H; Shepstone, Lee; Wilson, Edward C F; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise

2016-03-01

There is a growing interest in using cognitive-behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. None. © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence.

Higher organ donation consent rates by relatives of potential uncontrolled donors versus potential controlled donors after death.

PubMed

Wind, Jentina; van Mook, Walther N K A; Willems, Monique E C; van Heurn, L W Ernest

2012-11-01

Refusal to consent to organ donation is an important cause of the persisting gap between the number of potential organ donors and effectuated donors. In the Netherlands, organ donors include both uncontrolled donors: donors who die unexpectedly after cardiac death (DCD), after failed resuscitation and donors in whom death can be expected and donors after brain death, and controlled DCD donors: those who die after the withdrawal of treatment. Different donor type implies a different setting in which relatives are requested to consent to organ donation. It is unknown whether the setting influences the eventual decision for donation or not. Therefore, we compared the consent rate in potential donors who died unexpectedly (UD group) and in whom death was expected. A total of 523 potential organ donors between 2003 and 2011 in the 715-bed Maastricht University Medical Centre, the Netherlands were included. Both the patients' registration in the national donor register (DR) and the relatives' refusal rate in the two groups were retrospectively assessed using data from the donation application database. There were 109 unexpected and 414 expected potential donors The potential donors in the UD group were younger (mean age 52 versus 55 years, P = 0.032) and more often male (68 versus 52%, P = 0.003). There were no significant differences in registration in the DR between the groups. The relatives' consent rate in non-registered potential donors, or those who mandated the relatives for that decision, was higher in the UD group (53 versus 29%, P < 0.001). Less than 50% of the potential donors were registered in the national DR. Therefore, the relatives have an important role in the choice for organ donation. The relatives of potential donors who died unexpectedly consented more often to donation than those in whom death was expected.

41 CFR 101-42.1102-5 - Drugs, biologicals, and reagents other than controlled substances.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 41 Public Contracts and Property Management 2 2013-07-01 2012-07-01 true Drugs, biologicals, and... transferred for animal experimental use on a case-by-case basis subject to prior approval by GSA. (b) Donation.... However, items determined unfit because of expired shelf life may be donated for animal experimental use...

41 CFR 101-42.1102-5 - Drugs, biologicals, and reagents other than controlled substances.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 2 2010-07-01 2010-07-01 true Drugs, biologicals, and... transferred for animal experimental use on a case-by-case basis subject to prior approval by GSA. (b) Donation.... However, items determined unfit because of expired shelf life may be donated for animal experimental use...

41 CFR 101-42.1102-5 - Drugs, biologicals, and reagents other than controlled substances.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 41 Public Contracts and Property Management 2 2014-07-01 2012-07-01 true Drugs, biologicals, and... transferred for animal experimental use on a case-by-case basis subject to prior approval by GSA. (b) Donation.... However, items determined unfit because of expired shelf life may be donated for animal experimental use...

41 CFR 101-42.1102-5 - Drugs, biologicals, and reagents other than controlled substances.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 41 Public Contracts and Property Management 2 2011-07-01 2007-07-01 true Drugs, biologicals, and... transferred for animal experimental use on a case-by-case basis subject to prior approval by GSA. (b) Donation.... However, items determined unfit because of expired shelf life may be donated for animal experimental use...

Patient-oriented randomisation: A new trial design applied in the Neuroleptic Strategy Study.

PubMed

Schulz, Constanze; Timm, Jürgen; Cordes, Joachim; Gründer, Gerhard; Mühlbauer, Bernd; Rüther, Eckart; Heinze, Martin

2016-06-01

The 'gold standard' for clinical studies is a randomised controlled trial usually comparing specific treatments. If the scientific study expands to strategy comparison with each strategy including various treatments, the research problems are increasingly complicated. The strategy debate in the psychiatric community is the starting point for the development of our new design. It is widely accepted that second-generation antipsychotics are the therapy of choice in the treatment of schizophrenia. However, their general superiority over first-generation antipsychotics could not be demonstrated in recent randomised controlled trials. Furthermore, we are becoming increasingly aware that the experimental conditions of randomised controlled trials, as in the European First Episode Schizophrenia Trial and Clinical Antipsychotic Trials of Intervention Effectiveness Phase 1 studies, may be inappropriate for psychiatric treatments. The high heterogeneity in the patient population produces discrepancies between daily clinical perception and randomised controlled trials results. The patient-oriented approach in the Cost Utility of the Latest Antipsychotic drugs in Schizophrenia Study reflects everyday clinical practice. The results, however, are highly dependent on the physicians' preferences. The goal of the design described here is to take an intermediate path between randomised controlled trials and clinical studies such as Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study, combining the advantages of both study types. The idea is to randomise two treatment pairs each consisting of one first-generation antipsychotic and one second-generation antipsychotic in a first step and subsequently, to involve the investigators in deciding for a pair most appropriate to the patients' needs and then to randomise the allocation to one drug (first-generation antipsychotic or second-generation antipsychotic) of that chosen pair. This idea was first implemented in the clinical trial, the Neuroleptic Strategy Study, with a randomised design comparing efficacy and safety of two different strategies: either to use first-generation antipsychotics (haloperidol and flupentixol) or second-generation antipsychotics (olanzapine, aripiprazole and quetiapine) in patients suffering from schizophrenia. In the course of the Neuroleptic Strategy Study, feasibility of this design was demonstrated. All aspects of the new design were implemented: randomisation process, documentation of responses from investigators as well as patients and drug logistic experience. In implementing the design, furthermore, we could investigate its theoretical properties. The physicians' preferences for specific drugs used for the respective patients were analysed. The idea of patient-oriented randomisation can be generalised. In light of the heterogeneity and complexity of patient-drug interaction, this design should prove particularly useful. © The Author(s) 2016.

Differences in social representation of blood donation between donors and non-donors: an empirical study.

PubMed

Guarnaccia, Cinzia; Giannone, Francesca; Falgares, Giorgio; Caligaris, Aldo Ozino; Sales-Wuillemin, Edith

2015-11-04

Both donors and non-donors have a positive image of blood donation, so donors and non-donors do not differ regarding their views on donation but do differ in converting their opinion into an active deed of donation. Several studies have identified altruism and empathy as the main factors underlying blood donation. However, a mixture of various motivational factors mould the complex behaviour of donation. This paper presents an exploratory study on differences of social representations of blood donation between blood donors and non-donors, in order to understand the reasons that bring someone to take the decision to become a blood donor. Participants filled in the Adapted Self-Report Altruism Scale, Toronto Empathy Questionnaire and answered a test of verbal association. Descriptive and correlation analyses were carried out on quantitative data, while a prototypic analysis was used for qualitative data. The study was carried out on a convenience sample of 786 individuals, 583 donors (mean age: 35.40 years, SD: 13.01 years; 39.3% female) and 203 non-donors (mean age: 35.10 years, SD: 13.30 years; 67.5% female). Social representations of donors seem to be more complex and articulated than those of non-donors. The terms that appear to be central were more specific in donors (life, needle, blood, help, altruism were the words most associated by non-donors; life, aid, altruism, solidarity, health, love, gift, generosity, voluntary, control, needed, useful, needle were the words most associated by donors). Furthermore, non-donors associated a larger number of terms referring to negative aspects of blood donation. Aspects related to training and the accuracy of any information on blood donation seem to be important in the decision to become a donor and stabilise the behaviour of donation over time, thus ensuring the highest levels of quality and safety in blood establishments.

Effects of compassion meditation on a psychological model of charitable donation.

PubMed

Ashar, Yoni K; Andrews-Hanna, Jessica R; Yarkoni, Tal; Sills, Jenifer; Halifax, Joan; Dimidjian, Sona; Wager, Tor D

2016-08-01

Compassion is critical for societal wellbeing. Yet, it remains unclear how specific thoughts and feelings motivate compassionate behavior, and we lack a scientific understanding of how to effectively cultivate compassion. Here, we conducted 2 studies designed to a) develop a psychological model predicting compassionate behavior, and b) test this model as a mediator of a Compassion Meditation (CM) intervention and identify the "active ingredients" of CM. In Study 1, we developed a model predicting compassionate behavior, operationalized as real-money charitable donation, from a linear combination of self-reported tenderness, personal distress, perceived blamelessness, and perceived instrumental value of helping with high cross-validated accuracy, r = .67, p < .0001. Perceived similarity to suffering others did not predict charitable donation when controlling for other feelings and attributions. In Study 2, a randomized controlled trial, we tested the Study 1 model as a mediator of CM and investigated active ingredients. We compared a smartphone-based CM program to 2 conditions-placebo oxytocin and a Familiarity intervention-to control for expectancy effects, demand characteristics, and familiarity effects. Relative to control conditions, CM increased charitable donations, and changes in the Study 1 model of feelings and attributions mediated this effect (pab = .002). The Familiarity intervention led to decreases in primary outcomes, while placebo oxytocin had no significant effects on primary outcomes. Overall, this work contributes a quantitative model of compassionate behavior, and informs our understanding of the change processes and intervention components of CM. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Health care costs for the evaluation, surgery, and follow-up care of living kidney donors.

PubMed

Habbous, Steven; Sarma, Sisira; Barnieh, Lianne; McArthur, Eric; Klarenbach, Scott; Manns, Braden; Begen, Mehmet A; Lentine, Krista L; Garg, Amit X

2018-04-19

The health care costs to evaluate, perform surgery, and follow a living kidney donor for the year after donation are poorly described. We obtained information on the health care costs of 1099 living kidney donors between April 1, 2004 and March 31, 2014 from Ontario, Canada using comprehensive health care administrative databases. We estimated the cost of 3 periods of the living donation process: the predonation evaluation period (start of evaluation until the day before donation), perioperative period (day of donation until 30-days postdonation), and 1 year of follow-up period (after perioperative period until 1-year postdonation). We analyzed data for donors and healthy matched nondonor controls using regression-based methods to estimate the incremental cost of living donation. Costs are presented from the perspective of the Canadian health care payer (2017 $CAD). The incremental health care costs (compared with controls) for the evaluation, perioperative, and follow-up periods were $3,596 (95% confidence interval (CI) $3,350-$3,842), $11,694 ($11,415-$11,973), and $1,011 ($793-$1,230), respectively, totalling $16,290 ($15,814-$16,767). The evaluation cost was higher if the intended recipient started dialysis part-way through the donor evaluation [$886 ($19, $1,752)]. The perioperative cost varied across transplant centers (p<0.0001). While substantial costs of living donor care are related to the nephrectomy procedure, comprehensive assessment of costs must also include the evaluation and follow-up periods. These estimates are informative for planning future work to support and expand living donation and transplantation, and directing efforts to improve the cost efficiency of living donor care.

Quantity, topics, methods and findings of randomised controlled trials published by German university departments of general practice - systematic review.

PubMed

Heinmüller, Stefan; Schneider, Antonius; Linde, Klaus

2016-04-23

Academic infrastructures and networks for clinical research in primary care receive little funding in Germany. We aimed to provide an overview of the quantity, topics, methods and findings of randomised controlled trials published by German university departments of general practice. We searched Scopus (last search done in April 2015), publication lists of institutes and references of included articles. We included randomised trials published between January 2000 and December 2014 with a first or last author affiliated with a German university department of general practice or family medicine. Risk of bias was assessed with the Cochrane tool, and study findings were quantified using standardised mean differences (SMDs). Thirty-three trials met the inclusion criteria. Seventeen were cluster-randomised trials, with a majority investigating interventions aimed at improving processes compared with usual care. Sample sizes varied between 6 and 606 clusters and 168 and 7807 participants. The most frequent methodological problem was risk of selection bias due to recruitment of individuals after randomisation of clusters. Effects of interventions over usual care were mostly small (SMD <0.3). Sixteen trials randomising individual participants addressed a variety of treatment and educational interventions. Sample sizes varied between 20 and 1620 participants. The methodological quality of the trials was highly variable. Again, effects of experimental interventions over controls were mostly small. Despite limited funding, German university institutes of general practice or family medicine are increasingly performing randomised trials. Cluster-randomised trials on practice improvement are a focus, but problems with allocation concealment are frequent.

The effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial.

PubMed

Kuyken, Willem; Nuthall, Elizabeth; Byford, Sarah; Crane, Catherine; Dalgleish, Tim; Ford, Tamsin; Greenberg, Mark T; Ukoumunne, Obioha C; Viner, Russell M; Williams, J Mark G

2017-04-26

Mindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness or cost-effectiveness for young people. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of a mindfulness training (MT) programme to enhance mental health, wellbeing and social-emotional behavioural functioning in adolescence. To address this aim, the design will be a superiority, cluster randomised controlled, parallel-group trial in which schools offering social and emotional provision in line with good practice (Formby et al., Personal, Social, Health and Economic (PSHE) Education: A mapping study of the prevalent models of delivery and their effectiveness, 2010; OFSTED, Not Yet Good Enough: Personal, Social, Health and Economic Education in schools, 2013) will be randomised to either continue this provision (control) or include MT in this provision (intervention). The study will recruit and randomise 76 schools (clusters) and 5700 school students aged 12 to 14 years, followed up for 2 years. The study will contribute to establishing if MT is an effective and cost-effective approach to promoting mental health in adolescence. International Standard Randomised Controlled Trials, identifier: ISRCTN86619085 . Registered on 3 June 2016.

Psychosocial consequences of allocation to lung cancer screening: a randomised controlled trial.

PubMed

Aggestrup, Louise Mosborg; Hestbech, Mie Sara; Siersma, Volkert; Pedersen, Jesper Holst; Brodersen, John

2012-01-01

To examine the psychosocial consequences of being allocated to the control group as compared with the screen group in a randomised lung cancer screening trial. The Danish Lung Cancer Screening Trial, a randomised controlled trial, ran from 2004 to 2010 with the purpose of investigating the benefits and harms of lung cancer screening. The participants in Danish Lung Cancer Screening Trial were randomised to either the control group or the screen group and were asked to complete the questionnaires Consequences Of Screening and Consequences Of Screening in Lung Cancer (COS-LC). The Consequences Of Screening and the COS-LC were used to examine the psychosocial consequences of participating in the study, by comparing the control and the screen groups' responses at the prevalence and at the incidence round. There was no statistically significant difference in socio-demographic characteristics or smoking habits between the two groups. Responses to the COS-LC collected before the incidence round were statistically significantly different on the scales 'anxiety', 'behaviour', 'dejection', 'self-blame', 'focus on airway symptoms' and 'introvert', with the control group reporting higher negative psychosocial consequences. Furthermore, the participants in both the control and the screen groups exhibited a mean increase in negative psychosocial consequences when their responses from the prevalence round were compared with their responses from the first incidence round. Participation in a randomised controlled trial on lung cancer screening has negative psychosocial consequences for the apparently healthy participants-both the participants in the screen group and the control group. This negative impact was greatest for the control group.

A public-private partnership for malaria control: lessons from the Malarone Donation Programme.

PubMed Central

Oyediran, A. B. O. Olukayode; Ddumba, Edward M.; Ochola, Samuel A.; Lucas, Adetokunbo O.; Koporc, Kim; Dowdle, Walter R.

2002-01-01

In 1996, Glaxo Wellcome offered to donate up to a million treatment courses annually of Malarone, a new antimalarial, with a view to reducing the global burden of malaria. The Malarone Donation Programme (MDP) was established the following year. Eight pilot sites were selected in Kenya and Uganda to develop and evaluate an effective, locally sustainable donation strategy that ensured controlled and appropriate use of Malarone. The pilot programme targeted individuals who had acute uncomplicated Plasmodium falciparum malaria that had not responded to first-line treatments with chloroquine or sulfadoxine-pyrimethamine. Of the 161 079 patients clinically diagnosed at the pilot sites as having malaria, 1101 (0.68%) met all the conditions for participation and received directly observed treatment with Malarone. MDP had a positive effect at the pilot sites by improving the diagnosis and management of malaria. However, the provision of Malarone as a second-line drug at the district hospital level was not an efficient and effective use of resources. The number of deaths among children and adults ineligible for MDP at the pilot sites suggested that high priority should be given to meeting the challenges of malaria treatment at the community level. PMID:12471403

Comparison of anticipated and actual control group outcomes in randomised trials in paediatric oncology provides evidence that historically controlled studies are biased in favour of the novel treatment.

PubMed

Moroz, Veronica; Wilson, Jayne S; Kearns, Pamela; Wheatley, Keith

2014-12-10

Historically controlled studies are commonly undertaken in paediatric oncology, despite their potential biases. Our aim was to compare the outcome of the control group in randomised controlled trials (RCTs) in paediatric oncology with those anticipated in the sample size calculations in the protocols. Our rationale was that, had these RCTs been performed as historical control studies instead, the available outcome data used to calculate the sample size in the RCT would have been used as the historical control outcome data. A systematic search was undertaken for published paediatric oncology RCTs using the Cochrane Central Register of Controlled Trials (CENTRAL) database from its inception up to July 2013. Data on sample size assumptions and observed outcomes (timetoevent and proportions) were extracted to calculate differences between randomised and historical control outcomes, and a one-sample t-test was employed to assess whether the difference between anticipated and observed control groups differed from zero. Forty-eight randomised questions were included. The median year of publication was 2005, and the range was from 1976 to 2010. There were 31 superiority and 11 equivalence/noninferiority randomised questions with time-to-event outcomes. The median absolute difference between observed and anticipated control outcomes was 5.0% (range: -23 to +34), and the mean difference was 3.8% (95% CI: +0.57 to +7.0; P = 0.022). Because the observed control group (that is, standard treatment arm) in RCTs performed better than anticipated, we found that historically controlled studies that used similar assumptions for the standard treatment were likely to overestimate the benefit of new treatments, potentially leading to children with cancer being given ineffective therapy that may have additional toxicity.

Dual chamber stent prevents organ malperfusion in a model of donation after cardiac death.

PubMed

Tillman, Bryan W; Chun, Youngjae; Cho, Sung Kwon; Chen, Yanfei; Liang, Nathan; Maul, Timothy; Demetris, Anthony; Gu, Xinzhu; Wagner, William R; Tevar, Amit D

2016-10-01

The paradigm for donation after cardiac death subjects donor organs to ischemic injury. A dual-chamber organ perfusion stent would maintain organ perfusion without affecting natural cardiac death. A center lumen allows uninterrupted cardiac blood flow, while an external chamber delivers oxygenated blood to the visceral vessels. A prototype organ perfusion stent was constructed from commercial stents. In a porcine model, the organ perfusion stent was deployed, followed by a simulated agonal period. Oxygenated blood perfused the external stent chamber. Organ perfusion was compared between controls (n = 3) and organ perfusion stent (n = 6). Finally, a custom, nitinol, dual chamber organ perfusion stent was fabricated using a retrievable "petal and stem" design. Endovascular organ perfusion stent deployment achieved visceral isolation without adverse impact on cardiac parameters. Visceral oxygen delivery was 4.8-fold greater compared with controls. During the agonal period, organs in organ perfusion stent-treated animals appeared well perfused in contrast with the malperfused controls. A custom nitinol and polyurethane organ perfusion stent was recaptured easily with simple sheath advancement. An organ perfusion stent maintained organ perfusion during the agonal phase in a porcine model of donation after cardiac death organ donation without adversely affecting cardiac function. Ultimately, the custom retrievable design of this study may help resolve the critical shortage of donor organs for transplant. Copyright © 2016 Elsevier Inc. All rights reserved.

Determining the effect of vein visualization technology on donation success, vasovagal symptoms, anxiety and intention to re-donate in whole blood donors aged 18-30 years: A randomized controlled trial.

PubMed

Waller, D; Mondy, P; Brama, T; Fisher, J; King, A; Malkov, K; Wall-Smith, D; Ryan, L; Irving, D O

2016-08-01

Vein visualization technology (VVT) devices use near-infrared light to assist location of peripheral veins. The current study investigated the impact of VVT on donor experience and collection success for young blood donors at the Australian Red Cross Blood Service. The study in donors aged 18 to 30 years used a two intervention to one control randomized trial design with 285 new and 587 returning donors recruited at two sites. Donors reported presyncopal symptoms, phlebotomy pain, anxiety and intentions to redonate along with other measures. Participating phlebotomists rated usefulness of the technology. Flow rates, collection volumes and other donation information were taken from routine data. No significant differences were found between control and intervention groups on presyncopal symptoms, phlebotomy pain, anxiety, intentions to redonate, flow rates, collection volumes or vasovagal reactions (all P's > 0·05). Phlebotomist ratings of VVT were significantly more positive when they had less than 5 years of experience (P < 0·01) or when the vein was not visible to the naked eye (P < 0·01). Results suggest that VVT does not improve the donation experience for younger blood donors. Staff reports indicate that VVT may have some utility for assisting with difficult phlebotomies. © 2016 International Society of Blood Transfusion.

Altruism costs—the cheap signal from amygdala

PubMed Central

Sundberg, Marcus; Maeder, Johanna; Fransson, Peter; Petrovic, Predrag; Isacsson, Gunnar; Karlström, Anders; Ingvar, Martin

2014-01-01

When people state their willingness to pay for something, the amount usually differs from the behavior in a real purchase situation. The discrepancy between a hypothetical answer and the real act is called hypothetical bias. We investigated neural processes of hypothetical bias regarding monetary donations to public goods using fMRI with the hypothesis that amygdala codes for real costs. Real decisions activated amygdala more than hypothetical decisions. This was observed for both accepted and rejected proposals. The more the subjects accepted real donation proposals the greater was the activity in rostral anterior cingulate cortex—a region known to control amygdala but also neural processing of the cost-benefit difference. The presentation of a charitable donation goal evoked an insula activity that predicted the later decision to donate. In conclusion, we have identified the neural mechanisms underlying real donation behavior, compatible with theories on hypothetical bias. Our findings imply that the emotional system has an important role in real decision making as it signals what kind of immediate cost and reward an outcome is associated with. PMID:23945997

Immediate and long-term somatic effects, and health-related quality of life of BM donation during early childhood. A single-center report in 210 pediatric donors.

PubMed

van Walraven, S M; Straathof, L M; Switzer, G E; Lankester, A; Korthof, E T; Brand, A; Ball, L M

2013-01-01

Since 1968, when Leiden undertook the first successful European pediatric BM transplantation with a 7-year-old sibling donor, more than 300 young children have donated BM in our unit. We first retrospectively studied a cohort of 210 donors, younger than 13 years at donation, to survey procedures of donor eligibility and study immediate effects of BM donation. We then performed a long-term follow-up (FU) and health-related quality of life (HRQoL) study. Despite documentation of previous medical conditions, no child was declared unfit to donate. We found that iron deficiency anemia or low-iron stores in BM did not result in treatment or extended FU. Harvest volumes exceeded 15 mL/kg in 65% of donors, with more than half requiring allogeneic blood transfusions. Donors had no structured FU after their first post-donation control. In this study, 25% of donors reported at least one somatic complaint at long-term FU. Finally long-term HRQoL revealed high scores in most subdomains (representing a higher QoL), compared to norm groups. These results indicate the need for development of (inter)national guidelines for pediatric stem cell donor care management.

Marital Status and Return to Work After Living Kidney Donation.

PubMed

Frech, Adrianne; Natale, Ginny; Hayes, Don; Tumin, Dmitry

2018-01-01

Living kidney donation is safe and effective, but patients in need of a transplant continue to outnumber donors. Disincentives to living donation include lost income, risk of job loss, perioperative complications, and unreimbursed medical expenses. This study uses US registry and follow-up data on living kidney donors from 2013 to 2015 to identify social predictors of return to work across gender following living kidney donation. Using logistic regression, we find that predictors of return to work following living kidney donation differ for women and men. Among women, age, education, smoking status, and procedure type are associated with return to work. Among men, education, procedure type, and hospital readmission within 6 weeks postdonation are associated with return to work. Notably, single and divorced men are less likely to return to work compared to married men (odds ratio [OR] for single men 0.51, 95% confidence interval [CI], 0.37-0.69, P < .001; OR for divorced men 0.51, 95% CI, 0.34-0.75, P = .006). Marital status is not associated with return to work for women. Single and divorced men's greater odds of not returning to work are robust to controls for relevant pre- and postdonation characteristics. Single and divorced men's lack of social support may present an obstacle to work resumption following living kidney donation.

For love or money? Attitudes toward financial incentives among actual living kidney donors.

PubMed

van Buren, M C; Massey, E K; Maasdam, L; Zuidema, W C; Hilhorst, M T; Ijzermans, J N; Weimar, W

2010-11-01

Due to lengthening waiting lists for kidney transplantation, a debate has emerged as to whether financial incentives should be used to stimulate living kidney donation. In recent surveys among the general public approximately 25% was in favor of financial incentives while the majority was opposed or undecided. In the present study, we investigated the opinion of living kidney donors regarding financial incentives for living kidney donation. We asked 250 living kidney donors whether they, in retrospect, would have wanted a financial reward for their donation. We also investigated whether they were in favor of using financial incentives in a government-controlled system to stimulate living anonymous donation. Additionally, the type of incentive deemed most appropriate was also investigated. In general almost half (46%) of the study population were positive toward introducing financial incentives for living donors. The majority (78%) was not in favor of any kind of reward for themselves as they had donated out of love for the recipient or out of altruistic principles. Remarkably, 60% of the donors were in favor of a financial incentive for individuals donating anonymously. A reduced premium or free health insurance was the preferred incentive. ©2010 The Authors Journal compilation©2010 The American Society of Transplantation and the American Society of Transplant Surgeons.

Breakdown in the organ donation process and its effect on organ availability.

PubMed

Razdan, Manik; Degenholtz, Howard B; Kahn, Jeremy M; Driessen, Julia

2015-01-01

Background. This study examines the effect of breakdown in the organ donation process on the availability of transplantable organs. A process breakdown is defined as a deviation from the organ donation protocol that may jeopardize organ recovery. Methods. A retrospective analysis of donation-eligible decedents was conducted using data from an independent organ procurement organization. Adjusted effect of process breakdown on organs transplanted from an eligible decedent was examined using multivariable zero-inflated Poisson regression. Results. An eligible decedent is four times more likely to become an organ donor when there is no process breakdown (adjusted OR: 4.01; 95% CI: 1.6838, 9.6414; P < 0.01) even after controlling for the decedent's age, gender, race, and whether or not a decedent had joined the state donor registry. However once the eligible decedent becomes a donor, whether or not there was a process breakdown does not affect the number of transplantable organs yielded. Overall, for every process breakdown occurring in the care of an eligible decedent, one less organ is available for transplant. Decedent's age is a strong predictor of likelihood of donation and the number of organs transplanted from a donor. Conclusion. Eliminating breakdowns in the donation process can potentially increase the number of organs available for transplant but some organs will still be lost.

Oral antioxidant therapy for marginal dry eye.

PubMed

Blades, K J; Patel, S; Aidoo, K E

2001-07-01

To assess the efficacy of an orally administered antioxidant dietary supplement for managing marginal dry eye. A prospective, randomised, placebo controlled trial with cross-over. Eye Clinic, Department of Vision Sciences, Glasgow Caledonian University. Forty marginal dry eye sufferers composed of 30 females and 10 males (median age 53 y; range 38-69 y). Baseline assessments were made of tear volume sufficiency (thread test), tear quality (stability), ocular surface status (conjunctival impression cytology) and dry eye symptoms (questionnaire). Each subject was administered courses of active treatment, placebo and no treatment, in random order for 1 month each and results compared to baseline. Tear stability and ocular surface status were significantly improved following active treatment (P<0.05). No changes from baseline were detected following administration of placebo and no treatment (P>0.05). Absolute increase in tear stability correlated with absolute change in goblet cell population density. Tear volume was not improved following any treatment period and dry eye symptom responses were subject to placebo effect. Oral antioxidants improved both tear stability and conjunctival health, although it is not yet understood whether increased ocular surface health mediates increased tear stability or vice versa. This study was supported by a PhD scholarship funded by the Department of Vision Sciences, Glasgow Caledonian University, Scotland. Antioxidant supplements and placebos were kindly donated by Vitabiotics.

Organ donation after assisted death: Is it more or less ethically-problematic than donation after circulatory death?

PubMed

Kirby, Jeffrey

2016-12-01

A provocative question has emerged since the Supreme Court of Canada's decision on assisted dying: Should Canadians who request, and are granted, an assisted death be considered a legitimate source of transplantable organs? A related question is addressed in this paper: is controlled organ donation after assisted death (cDAD) more or less ethically-problematic than standard, controlled organ donation after circulatory determination of death (cDCDD)? Controversial, ethics-related dimensions of cDCD that are of relevance to this research question are explored, and morally-relevant distinctions between cDAD and cDCD are identified. In addition, a set of morally-relevant advantages of one practice over the other is uncovered, and a few potential, theoretical issues specifically related to cDAD practice are articulated. Despite these concerns, the analysis suggests a counterintuitive conclusion: cDAD is, overall, less ethically-problematic than cDCDD. The former practice better respects the autonomy interests of the potential donor, and a claim regarding irreversibility of cessation of the donor's circulatory function in the cDAD context can be supported. Further, with cDAD, there is no possibility that the donor will have negative sensory experiences during organ procurement surgery. Although the development of appropriate policy-decision and regulatory approaches in this domain will be complex and challenging, the comparative ethical analysis of these two organ donation practices has the potential to constructively inform the deliberations of relevant stakeholders, resource persons and decision makers.

Risk of bias assessment of randomised controlled trials in high-impact ophthalmology journals and general medical journals: a systematic review.

PubMed

Joksimovic, Lazar; Koucheki, Robert; Popovic, Marko; Ahmed, Yusuf; Schlenker, Matthew B; Ahmed, Iqbal Ike K

2017-10-01

Evidence-based treatments in ophthalmology are often based on the results of randomised controlled trials. Biased conclusions from randomised controlled trials may lead to inappropriate management recommendations. This systematic review investigates the prevalence of bias risk in randomised controlled trials published in high-impact ophthalmology journals and ophthalmology trials from general medical journals. Using Ovid MEDLINE, randomised controlled trials in the top 10 high-impact ophthalmology journals in 2015 were systematically identified and critically appraised for the prevalence of bias risk. Included randomised controlled trials were assessed in all domains of bias as defined by the Cochrane Collaboration. In addition, the prevalence of conflict of interest and industry sponsorship was investigated. A comparison with ophthalmology articles from high-impact general medical journals was performed. Of the 259 records that were screened from ophthalmology-specific journals, 119 trials met all inclusion criteria and were critically appraised. In total, 29.4% of domains had an unclear risk, 13.8% had a high risk and 56.8% had a low risk of bias. In comparison, ophthalmology articles from general medical journals had a lower prevalence of unclear risk (17.1%), higher prevalence of high risk (21.9%) and a higher prevalence of low risk domains (61.9%). Furthermore, 64.7% of critically appraised trials from ophthalmology-specific journals did not report any conflicts of interest, while 70.6% did not report an industry sponsor of their trial. In closing, it is essential that authors, peer reviewers and readers closely follow published risk of bias guidelines. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive–behavioural therapy

PubMed Central

Murphy, Glynis H.; Shepstone, Lee; Wilson, Edward C.F.; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise

2016-01-01

Background There is a growing interest in using cognitive–behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. Aims To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Method Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. Results The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Conclusions Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence. PMID:27703772

Policy statement--pediatric organ donation and transplantation.

PubMed

2010-04-01

Pediatric organ donation and organ transplantation can have a significant life-extending benefit to the young recipients of these organs and a high emotional impact on donor and recipient families. Pediatricians, pediatric medical specialists, and pediatric transplant surgeons need to be better acquainted with evolving national strategies that involve organ procurement and organ transplantation to help acquaint families with the benefits and risks of organ donation and transplantation. Efforts of pediatric professionals are needed to shape public policies to provide a system in which procurement, distribution, and cost are fair and equitable to children and adults. Major issues of concern are availability of and access to donor organs; oversight and control of the process; pediatric medical and surgical consultation and continued care throughout the organ-donation and transplantation process; ethical, social, financial, and follow-up issues; insurance-coverage issues; and public awareness of the need for organ donors of all ages.

A randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy: recruitment, refusal, randomisation and missing data.

PubMed

Lowther, Keira; Higginson, Irene J; Simms, Victoria; Gikaara, Nancy; Ahmed, Aabid; Ali, Zipporah; Afuande, Gaudencia; Kariuki, Hellen; Sherr, Lorraine; Jenkins, Rachel; Selman, Lucy; Harding, Richard

2014-09-03

Despite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy, the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown. A randomised controlled trial (RCT) was conducted in a sample of 120 HIV positive patients on ART in an urban clinic in Mombasa, Kenya. The intervention was a minimum of seven sessions of multidimensional, person-centred care, given by HIV nurses trained in the palliative care approach over a period of 5 months. Rates of recruitment and refusal, the effectiveness of the randomisation procedure, trial follow-up and attrition and extent of missing data are reported.120 patients (60 randomised to control arm, 60 randomised to intervention arm) were recruited over 5.5 months, with a refusal rate of 55.7%. During the study period, three participants died from cancer, three withdrew (two moved away and one withdrew due to time constraints). All of these patients were in the intervention arm: details are reported. There were five additional missing monthly interviews in both the control and intervention study arm, bringing the total of missing data to 26 data points (4.3%). The quality and implications of these data are discussed extensively and openly, including the effect of full and ethical consent procedures, respondent burden, HIV stigma, accurate randomisation, patient safety and the impact of the intervention. Data on recruitment randomisation, attrition and missing data in clinical trials should be routinely reported, in conjunction with the now established practice of publishing study protocols to enhance research integrity, transparency and quality. Transparency is especially important in cross cultural settings, in which the sources of funding and trial design are often not based in the country of data collection. Findings reported can be used to inform future RCTs in this area. Clinicaltrials.gov NCT01608802.

Confidential donation confirmation as an alternative to confidential unit exclusion: 15 months experience of the HEMOMINAS foundation.

PubMed

Loureiro, Flávia Cristine Martineli; Oliveira, Cláudia Di Lorenzo; Proietti, Anna Bárbara F Carneiro; Proietti, Fernando Augusto

2011-01-01

Confidential unit exclusion remains a controversial strategy to reduce the residual risk of transfusion-transmitted infections. This study aimed to analyze confidential unit exclusion from its development in a large institution in light of confidential donation confirmation. Data of individuals who donated from October 1, 2008 to December 31, 2009 were analyzed in a case-control study. The serological results and sociodemographic characteristics of donors who did not confirm their donations were compared to those who did. Variables with p-values < 0.20 in univariate analysis were included in a logistic multivariate analysis. In the univariate analysis there was a statically significant association between positive serological results and response to confidential donation confirmation of "No". Donation type, (firsttime or return donor - OR 1.69, CI 1.37-2.09), gender (OR 1.66, CI 1.35-2.04), education level (OR 2.82, CI 2.30-3.47) and ethnic background (OR 0.67, CI 0.55-0.82) were included in the final logistic regression model. In all logistic regression models analyzed, the serological suitability and confidential donation confirmation were not found to be statistically associated. The adoption of new measures of clinical classification such as audiovisual touch-screen computer-assisted self-administered interviews might be more effective than confidential unit exclusion in the identification of donor risk behavior. The requirement that transfusion services continue to use confidential unit exclusion needs to be debated in countries where more specific and sensitive clinical and serological screening methods are available. Our findings suggest that there are not enough benefits to justify continued use of confidential donation confirmation in the analyzed institution.

Confidential donation confirmation as an alternative to confidential unit exclusion: 15 months experience of the HEMOMINAS foundation

PubMed Central

Loureiro, Flávia Cristine Martineli; Oliveira, Cláudia Di Lorenzo; Proietti, Anna Bárbara F. Carneiro; Proietti, Fernando Augusto

2011-01-01

Background Confidential unit exclusion remains a controversial strategy to reduce the residual risk of transfusion-transmitted infections. Objective This study aimed to analyze confidential unit exclusion from its development in a large institution in light of confidential donation confirmation. Methods Data of individuals who donated from October 1, 2008 to December 31, 2009 were analyzed in a case-control study. The serological results and sociodemographic characteristics of donors who did not confirm their donations were compared to those who did. Variables with p-values < 0.20 in univariate analysis were included in a logistic multivariate analysis. Results In the univariate analysis there was a statically significant association between positive serological results and response to confidential donation confirmation of "No". Donation type, (firsttime or return donor - OR 1.69, CI 1.37-2.09), gender (OR 1.66, CI 1.35-2.04), education level (OR 2.82, CI 2.30-3.47) and ethnic background (OR 0.67, CI 0.55-0.82) were included in the final logistic regression model. In all logistic regression models analyzed, the serological suitability and confidential donation confirmation were not found to be statistically associated. The adoption of new measures of clinical classification such as audiovisual touch-screen computer-assisted self-administered interviews might be more effective than confidential unit exclusion in the identification of donor risk behavior. The requirement that transfusion services continue to use confidential unit exclusion needs to be debated in countries where more specific and sensitive clinical and serological screening methods are available. Conclusion Our findings suggest that there are not enough benefits to justify continued use of confidential donation confirmation in the analyzed institution. PMID:23049316

The knowns and unknowns of human milk banking.

PubMed

Simmer, Karen; Hartmann, Ben

2009-11-01

The PREM Bank has been providing pasteurised donor human milk (PDHM) to very preterm for the past 3 years. It is the first human milk bank (HMB) to operate in Australia in over 20 years. Our community has rapidly embraced the concept of human milk banking, with both donations and demand for PDHM exceeding expectations. Providing PDHM in 'exceptional circumstances' where a mothers' own milk is unavailable is supported by the WHO and UNICEF. We submit that neonatal intensive care is an exceptional circumstance. Although evidence supporting PDHM use from randomised control trial (RCT) is limited, the latest systematic reviews suggest a lower risk of necrotising enterocolitis with PDHM as opposed to artificial formula. Study design and ethical issues may limit future evidence from RCT. We therefore support the ongoing use of PDHM in neonatal care, where provided by an appropriately managed HMB. Internationally many HMBs operate unregulated, and this is also the case in Australia. To ensure safety the PREM Bank has committed to meet the appropriate standards recommended in the Code of Good Manufacturing Practices (Blood and Tissues) in Australia and models risk management during processing on Codex HACCP (Hazard Analysis Critical Control Point) requirements. There is scope to continually re-evaluate the screening of donors and quality standards recommended during HMB. This will be most effective if strong networks of HMBs are developed with regional reference laboratories to encourage compliance with safety guidelines. HMB networks will facilitate collection of evidence for refining HMB practice and improving outcomes for preterm and sick infants.

Prevalence of human immunodeficiency virus RNA and antibody in first-time, lapsed, and repeat blood donations across five international regions and relative efficacy of alternative screening scenarios.

PubMed

Bruhn, Roberta; Lelie, Nico; Custer, Brian; Busch, Michael; Kleinman, Steven

2013-10-01

Twenty-one blood organizations from five geographical regions provided HIV individual donation (ID)-NAT and serology data on 11,787,610 donations. Infections were classified as anti-HIV-/RNA+ window period (WP), anti-HIV+/RNA+ concordant positive (CP) or anti-HIV+/RNA- elite controller (EC). Residual risk and efficacy of several screening scenarios were estimated for first time, lapsed and repeat donations. WP residual risk estimates assumed a 50% infectious dose of 3.16 virions and a 50% detection limit of 2.7 HIV RNA copies/mL for ID-NAT and 10,000 copies/mL for p24Ag. Infectivity for CP (100%) and EC (2.2%) donations was estimated based on viral load distributions and 100-fold reduced infectivity by antibody neutralization as reported elsewhere. Efficacy was calculated as proportion of transmission risk removed from baseline (i.e. in absence of any screening). There was no significant difference in transmission risk between lapsed and repeat donations in any region. Risk was 3.8-fold higher in first time than combined lapsed/repeat donations in South Africa but not in other regions. Screening strategies were most efficacious at interdicting infectious transfusions in first time (98.7-99.8%) followed by lapsed (97.6-99.7%) and repeat (86.8-97.7%) donations in all regions combined. In each donor category the efficacy of ID-NAT alone (97.7-99.8%) was superior to that of minipool (MP)-NAT/anti-HIV (95.0-99.6%) and p24 Ag/anti-HIV (89.8-99.1%). Efficacy patterns were similar by donor/donation status in each region despite large differences in HIV prevalence and transmission risk. As similar data become available for HBV and HCV, this modeling may be useful in cost effectiveness analyses of alternative testing scenarios. © 2013 American Association of Blood Banks.

How does the general public view posthumous organ donation? A meta-synthesis of the qualitative literature

PubMed Central

2011-01-01

Background Many individuals are unwilling to become posthumous organ donors, resulting in a disparity between the supply and demand for organ transplants. A meta-synthesis of the qualitative literature was therefore conducted to determine how the general public views posthumous organ donation. Methods Three online databases (PubMed, PsycINFO, Scopus) were searched for articles published between January 1990 and May 2008 using the following search terms: organ donation, qualitative, interview. Eligibility criteria were: examination of beliefs about posthumous organ donation; utilization of a qualitative research design; and publication in an English peer-reviewed journal. Exclusion criteria were examining how health professionals or family members of organ donors viewed posthumous organ donation. Grounded theory was used to identify the beliefs emerging from this literature. Thematically-related beliefs were then grouped to form themes. Results 27 articles from 24 studies met the inclusion criteria and were reviewed. The major themes identified were: religion, death, altruism, personal relevance, the body, the family, medical professionals, and transplant recipients. An altruistic motivation to help others emerged as the most commonly identified motivator for becoming an organ donor, although feeling a sense of solidarity with the broader community and believing that donated organs are put to good use may be important preconditions for the emergence of this motivation. The two most commonly identified barriers were the need to maintain bodily integrity to safeguard progression into the afterlife and the unethical recovery of organs by medical professionals. The influence of stakeholder groups on willingness to become an organ donor was also found to vary by the level of control that each stakeholder group exerted over the donation recovery process and their perceived conflict of interest in wanting organ donation to proceed. Conclusions These findings afford insights into how individuals perceive posthumous organ donation. PMID:21988839

Psychosocial consequences of allocation to lung cancer screening: a randomised controlled trial

PubMed Central

Aggestrup, Louise Mosborg; Hestbech, Mie Sara; Siersma, Volkert; Pedersen, Jesper Holst

2012-01-01

Objective To examine the psychosocial consequences of being allocated to the control group as compared with the screen group in a randomised lung cancer screening trial. Method The Danish Lung Cancer Screening Trial, a randomised controlled trial, ran from 2004 to 2010 with the purpose of investigating the benefits and harms of lung cancer screening. The participants in Danish Lung Cancer Screening Trial were randomised to either the control group or the screen group and were asked to complete the questionnaires Consequences Of Screening and Consequences Of Screening in Lung Cancer (COS-LC). The Consequences Of Screening and the COS-LC were used to examine the psychosocial consequences of participating in the study, by comparing the control and the screen groups' responses at the prevalence and at the incidence round. Results There was no statistically significant difference in socio-demographic characteristics or smoking habits between the two groups. Responses to the COS-LC collected before the incidence round were statistically significantly different on the scales ‘anxiety’, ‘behaviour’, ‘dejection’, ‘self-blame’, ‘focus on airway symptoms’ and ‘introvert’, with the control group reporting higher negative psychosocial consequences. Furthermore, the participants in both the control and the screen groups exhibited a mean increase in negative psychosocial consequences when their responses from the prevalence round were compared with their responses from the first incidence round. Conclusions Participation in a randomised controlled trial on lung cancer screening has negative psychosocial consequences for the apparently healthy participants—both the participants in the screen group and the control group. This negative impact was greatest for the control group. PMID:22382119

Leptin, gastrointestinal and stress hormones in response to exercise in fasted or fed subjects and before or after blood donation.

PubMed

Sliwowski, Z; Lorens, K; Konturek, S J; Bielanski, W; Zoładź, J A

2001-03-01

Leptin, an ob gene product of adipocytes, plays a key role in the control of food intake and energy expenditure but little is known about leptin response to strenuous exercise in fasted and fed subjects or before and after blood donation. This study was designed to determine the immediate effects of strenuous exercise in healthy volunteers under fasting or fed conditions and before and one day after blood donation (450 ml) on plasma levels of leptin and gut hormones [gastrin, cholecystokinin (CCK), pancreatic polypeptide (PP) and insulin], as well as on "stress" hormones (cortisol, catecholamines and growth hormone. Two groups (A and B) of healthy non-smoking male volunteers were studied. All subjects performed incremental exercise tests until exhaustion (up to maximal oxygen uptake--VO2max), followed by 2 h of rest session. Group A perfomed the tests on a treadmill, while group B on a cycloergometer. In group A, one exercise was performed under fasting conditions and the second following ingestion of a standard liquid meal. In group B, one exercise test was performed as a control test and the second 24 h after blood donation (450 ml). Blood samples were withdrawn 5 min before the start of the test, at the VO2max, and 2 h after finishing the exercise. No significant change in plasma teptin were observed both immediately and 2 h after the exercise in fasted subjects, but after the meal the plasma leptin at VO2max and 2 h after the test was significantly higher, while after blood donation was significantly reduced. The postprandial rise in plasma leptin was accompanied by a marked increment in gut hormones; gastrin, CCK and PP and stress hormones such as norepinephrine, cortisol and GH. These hormonal changes could contribute to the postprandial rise in plasma leptin concentrations, while the fall of leptin after blood donation could be attributed to the inadequate response of stress hormones and autonomic nervous system to exhausting exercise. We conclude that strenuous physical exercise; 1) fails to affect plasma leptin level but when performed after meal but not after blood withdrawal it results in an increase and fall in plasma leptin, and 2) the release of gut hormones (gastrin, CCK and PP) and stress hormones (norepinephrine, cortisol, GH) increase immediately after exercise independently of feeding or blood donation and 3) following blood donation the strenuous exercise resulted in a marked reduction in the plasma leptin, cortisol and GH concentrations, possibly due to the impairment in the autonomic nervous control of these hormones.

Canadian Guidelines for Controlled Pediatric Donation After Circulatory Determination of Death-Summary Report.

PubMed

Weiss, Matthew J; Hornby, Laura; Rochwerg, Bram; van Manen, Michael; Dhanani, Sonny; Sivarajan, V Ben; Appleby, Amber; Bennett, Mary; Buchman, Daniel; Farrell, Catherine; Goldberg, Aviva; Greenberg, Rebecca; Singh, Ram; Nakagawa, Thomas A; Witteman, William; Barter, Jill; Beck, Allon; Coughlin, Kevin; Conradi, Alf; Cupido, Cynthia; Dawson, Rosanne; Dipchand, Anne; Freed, Darren; Hornby, Karen; Langlois, Valerie; Mack, Cheryl; Mahoney, Meagan; Manhas, Deepak; Tomlinson, Christopher; Zavalkoff, Samara; Shemie, Sam D

2017-11-01

Create trustworthy, rigorous, national clinical practice guidelines for the practice of pediatric donation after circulatory determination of death in Canada. We followed a process of clinical practice guideline development based on World Health Organization and Canadian Medical Association methods. This included application of Grading of Recommendations Assessment, Development, and Evaluation methodology. Questions requiring recommendations were generated based on 1) 2006 Canadian donation after circulatory determination of death guidelines (not pediatric specific), 2) a multidisciplinary symposium of national and international pediatric donation after circulatory determination of death leaders, and 3) a scoping review of the pediatric donation after circulatory determination of death literature. Input from these sources drove drafting of actionable questions and Good Practice Statements, as defined by the Grading of Recommendations Assessment, Development, and Evaluation group. We performed additional literature reviews for all actionable questions. Evidence was assessed for quality using Grading of Recommendations Assessment, Development, and Evaluation and then formulated into evidence profiles that informed recommendations through the evidence-to-decision framework. Recommendations were revised through consensus among members of seven topic-specific working groups and finalized during meetings of working group leads and the planning committee. External review was provided by pediatric, critical care, and critical care nursing professional societies and patient partners. We generated 63 Good Practice Statements and seven Grading of Recommendations Assessment, Development, and Evaluation recommendations covering 1) ethics, consent, and withdrawal of life-sustaining therapy, 2) eligibility, 3) withdrawal of life-sustaining therapy practices, 4) ante and postmortem interventions, 5) death determination, 6) neonatal pediatric donation after circulatory determination of death, 7) cardiac and innovative pediatric donation after circulatory determination of death, and 8) implementation. For brevity, 48 Good Practice Statement and truncated justification are included in this summary report. The remaining recommendations, detailed methodology, full Grading of Recommendations Assessment, Development, and Evaluation tables, and expanded justifications are available in the full text report. This process showed that rigorous, transparent clinical practice guideline development is possible in the domain of pediatric deceased donation. Application of these recommendations will increase access to pediatric donation after circulatory determination of death across Canada and may serve as a model for future clinical practice guideline development in deceased donation.

Donation after cardiocirculatory death in Canada

PubMed Central

Shemie, Sam D.; Baker, Andrew J.; Knoll, Greg; Wall, William; Rocker, Graeme; Howes, Daniel; Davidson, Janet; Pagliarello, Joe; Chambers-Evans, Jane; Cockfield, Sandra; Farrell, Catherine; Glannon, Walter; Gourlay, William; Grant, David; Langevin, Stéphan; Wheelock, Brian; Young, Kimberly; Dossetor, John

2006-01-01

These recommendations are the result of a national, multidisciplinary, year-long process to discuss whether and how to proceed with organ donation after cardiocirculatory death (DCD) in Canada. A national forum was held in February 2005 to discuss and develop recommendations on the principles, procedures and practice related to DCD, including ethical and legal considerations. At the forum's conclusion, a strong majority of participants supported proceeding with DCD programs in Canada. The forum also recognized the need to formulate and emphasize core values to guide the development of programs and protocols based on the medical, ethical and legal framework established at this meeting. Although end-of-life care should routinely include the opportunity to donate organs and tissues, the duty of care toward dying patients and their families remains the dominant priority of health care teams. The complexity and profound implications of death are recognized and should be respected, along with differing personal, ethnocultural and religious perspectives on death and donation. Decisions around withdrawal of life-sustaining therapies, management of the dying process and the determination of death by cardiocirculatory criteria should be separate from and independent of donation and transplant processes. The recommendations in this report are intended to guide individual programs, regional health authorities and jurisdictions in the development of DCD protocols. Programs will develop based on local leadership and advance planning that includes education and engagement of stakeholders, mechanisms to assure safety and quality and public information. We recommend that programs begin with controlled DCD within the intensive care unit where (after a consensual decision to withdraw life-sustaining therapy) death is anticipated, but has not yet occurred, and unhurried consent discussions can be held. Uncontrolled donation (where death has occurred after unanticipated cardiac arrest) should only be considered after a controlled DCD program is well established. Although we recommend that programs commence with kidney donation, regional transplant expertise may guide the inclusion of other organs. The impact of DCD, including pre-and post-mortem interventions, on donor family experiences, organ availability, graft function and recipient survival should be carefully documented and studied. PMID:17124739

Outcomes and Process in Reading Tutoring

ERIC Educational Resources Information Center

Topping, K. J.; Thurston, A.; McGavock, K.; Conlin, N.

2012-01-01

Background: Large-scale randomised controlled trials are relatively rare in education. The present study approximates to, but is not exactly, a randomised controlled trial. It was an attempt to scale up previous small peer tutoring projects, while investing only modestly in continuing professional development for teachers. Purpose: A two-year…

Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

PubMed Central

Glenton, Claire; Oxman, Andrew D

2009-01-01

Objective To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions. Design Review of randomised controlled trials of interventions to change professional practice or the organisation of care. Data sources Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group. Methods Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done. Results 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable. Conclusions Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings. PMID:19744976

Impact of growth hormone therapy on adult height of children with idiopathic short stature: systematic review.

PubMed

Deodati, Annalisa; Cianfarani, Stefano

2011-03-11

To systematically determine the impact of growth hormone therapy on adult height of children with idiopathic short stature. Systematic review. Cochrane Central Register of Controlled Trials, Medline, and the bibliographic references from retrieved articles of randomised and non-randomised controlled trials from 1985 to April 2010. Height in adulthood (standard deviation score) and overall gain in height (SD score) from baseline measurement in childhood. Randomised and non-randomised controlled trials with height measurements for adults. Inclusion criteria were initial short stature (defined as height >2 SD score below the mean), peak growth hormone responses >10 μg/L, prepubertal stage, no previous growth hormone therapy, and no comorbid conditions that would impair growth. Adult height was considered achieved when growth rate was <1.5 cm/year or bone age was 15 years in females and 16 years in males. Three randomised controlled trials (115 children) met the inclusion criteria. The adult height of the growth hormone treated children exceeded that of the controls by 0.65 SD score (about 4 cm). The mean height gain in treated children was 1.2 SD score compared with 0.34 SD score in untreated children. A slight difference of about 1.2 cm in adult height was observed between the two growth hormone dose regimens. In the seven non-randomised controlled trials the adult height of the growth hormone treated group exceeded that of the controls by 0.45 SD score (about 3 cm). Growth hormone therapy in children with idiopathic short stature seems to be effective in partially reducing the deficit in height as adults, although the magnitude of effectiveness is on average less than that achieved in other conditions for which growth hormone is licensed. The individual response to therapy is highly variable, and additional studies are needed to identify the responders.

The viability of transplanting organs from donors who underwent cardiopulmonary resuscitation: A systematic review.

PubMed

West, Stephen; Soar, Jasmeet; Callaway, Clifton W

2016-11-01

To identify reports of patients who underwent cardiopulmonary resuscitation (CPR) prior to solid organ donation and compare recipient and organ function outcomes to those that did not undergo CPR. Donation after restoration of circulation then progressing to death and those donating with on-going CPR who would have otherwise have termination of efforts were both included. Systematic review. Clinical studies comparing the outcome of patients and organs retrieved from donors who underwent CPR with those that did not require CPR. Full-text articles were searched on EmBASE, MEDLINE, Cochrane Database of Systematic Reviews and the Cochrane Register of Controlled Trials. Twenty-two observational studies were included. There were 12,206 adult and 2552 paediatric organ transplantation identified. Comparing donation after restoration of circulation there was no difference in immediate, one year, and five-year graft function. Donation with on-going CPR was associated with reduced immediate graft function for both renal and hepatic transplantation, however long term function was not different. CPR does not appear to adversely affect graft function. Patients who have restored circulation after resuscitation and subsequently progress to death should be evaluated for organ donation. Those with on-going CPR should be considered for hepatic and renal transplantation but there may be worse initial graft function. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Roles of sex and ethnicity in procurement coordinator--family communication during the organ donation discussion.

PubMed

Baughn, Daniel; Auerbach, Stephen M; Siminoff, Laura A

2010-09-01

Interpersonal relations with health care providers influence families' decisions to consent to solid-organ donation. However, previous research has been based on retrospective interviews with donation-eligible families and has not directly examined the interpersonal interactions between families and organ procurement coordinators. To increase understanding of the interpersonal interaction between procurement coordinators and families during the organ donation discussion, with special attention to the influence of the sex and race of the procurement coordinator and the race of the potential donor's family. A descriptive study in which standardized patients portrayed family members interacting with actual procurement coordinators in simulated donation request scenarios. Thirty-three videotaped interactions between standardized patients and 17 procurement coordinators involving 2 different scenarios depicting deceased donation were evaluated. Video recordings were rated by independent coders. Coders completed the Impact Message Inventory-Form C, the Participatory Style of Physician Scale, and the Siminoff Communication and Content and Affect Program-Global Observer Ratings scale. African American procurement coordinators, particularly African American women, were rated as more controlling and work-oriented than white procurement coordinators. Male procurement coordinators were more affiliative with the white family than the African American family, whereas female procurement coordinators were slightly less affiliative with the white family. African American procurement coordinators expressed more positive affect when interacting with the African American family than the white family, whereas the opposite was true for white procurement coordinators. Research is needed to cross-validate these exploratory findings and further examine cultural mistrust between procurement coordinators and families of ethnic minorities, especially given the negative attitudes of many minorities toward donation.

Increasing nondonors' intention to give blood: addressing common barriers.

PubMed

Balegh, Saharnaz; Marcus, Natania; Dubuc, Sophie; Godin, Gaston; France, Christopher R; Ditto, Blaine

2016-02-01

Recruiting new donors is a challenging experience for most blood collection agencies. A modest proportion of the population is eligible to give blood and few of these individuals volunteer. The goal of this study was to examine the effects of brief behavioral interventions on nondonors' intention to give blood, by addressing some commonly reported obstacles. A total of 244 young adults who were eligible to give blood but had never done so participated in the study. They were assigned randomly to an applied tension (AT) instruction condition, a relaxation instruction condition, a Web browsing condition, or a no-treatment control condition. After the 20-minute experimental intervention, half watched three short injection and blood draw videos and the others sat quietly. Intention to give blood and different cognitive constructs associated with blood donation were measured using a Theory of Planned Behavior questionnaire. Participants in all three active conditions had significantly greater increases in intention to donate blood compared to controls, although those who learned AT had greater increases than Web browsing. Bootstrapping tests of mediation indicated particular importance of increased perceived behavioral control in AT and relaxation treatment effects. Follow-up analyses revealed a significant association between degree of within-session increase in intention and subsequent blood clinic attendance. These results suggest that simple interventions can be effective in increasing nondonors' intention to donate blood and, perhaps, actual attendance. The mediational analyses suggest that interventions can selectively target different barriers associated with blood donation. © 2015 AABB.

A motivational interview promotes retention of blood donors with high internal motivation.

PubMed

France, Christopher R; France, Janis L; Carlson, Bruce W; Himawan, Lina K; Kessler, Debra A; Rebosa, Mark; Shaz, Beth H; Madden, Katrala; Carey, Patricia M; Slepian, P Maxwell; Ankawi, Brett; Livitz, Irina E; Fox, Kristen R

2017-10-01

Based on the hypothesis that self-determined motivation is associated with an increased likelihood of future behavior, the present study examined the ability of a motivational interview to promote internal motivation for giving blood and future donation attempts. A sample of 484 recent whole-blood and double red blood cell donors (62.4% female; age = 30.2 ± 11.8 years) were randomly assigned to either a telephone-delivered motivational interview or a control call approximately 6 weeks after donating. Several weeks before the call and again 1 week after the call, participants completed the Blood Donor Identity Survey, a multidimensional measure of donor motivation, to derive indices of amotivation, external motivation, and internal motivation to give blood. Repeat donation attempts were tracked using blood center records. Relative to controls, participants in the motivational interview group showed a shift toward more self-determined motivation, as indicated by significant decreases in amotivation (p = 0.01) and significant increases in external (p = 0.009) and internal (p = 0.002) motivation. Furthermore, those with initially high levels of autonomous motivation were more likely to make a donation attempt in the subsequent year if they completed the motivational interview (71.1%) versus the control call (55.1%). Motivational interviewing is a potentially useful strategy to enhance retention of existing blood donors, particularly among those who express a greater sense of internal motivation for giving. © 2017 AABB.

Controlled donation after circulatory death in the Netherlands: more organs, more efforts.

PubMed

Leiden, H; Haase-Kromwijk, B; Hoitsma, A; Jansen, N

2016-08-01

The Netherlands was one of the first countries in Europe to stimulate controlled donation after circulatory death (cDCD) at a national level in addition to donation after brain death (DBD). With this program the number of organ transplants increased, but it also proved to have challenges as will be shown in this 15-year review. Data about deceased organ donation in the Netherlands, from 2000 until 2014, were analysed taking into account the whole donation process from donor referral to the number of organs transplanted. Donor referral increased by 58%, from 213 to 336 donors per year, and the number of organs transplanted rose by 42%. Meanwhile the contribution of cDCD donors increased from 14% in 2000 to 54% in 2014 among all referrals. The organs were transplanted from 92-99% of referred DBD donors, but this percentage was significantly lower for cDCD donors and also decreased from 86% in 2000-2002 to 67% in 2012-2014. In 16% of all referred cDCD donors, organs were not recovered because donors did not die within the expected two-hour time limit after withdrawal of life- upporting treatment. Furthermore, cDCD is more often performed at a higher donor age, which is associated with a lower percentage of transplanted organs. Although cDCD resulted in more transplants, the effort in donor recruitment is considerably higher. Important challenges in cDCD that need further attention are the time limit after withdrawal of life-supporting treatment and donor age, as well as the possibilities to stimulate non-renal transplants including the heart by machine preservation.

Improving first-time donor attendance rates through the use of enhanced donor preparation materials.

PubMed

Masser, Barbara; France, Christopher R; Foot, Jayne; Rozsa, Amy; Hayman, Jane; Waller, Daniel; Hunder, Everard

2016-06-01

Many nondonors are positive about blood donation and this motivates booking an appointment to donate. However, as their appointment approaches barriers to donating-such as anxiety-may become salient and deter attendance. Building on research of France and colleagues demonstrating the positive effect of enhanced preparation materials on donor recruitment, this study sought to determine whether these materials could effectively boost first donation appointment attendance. A field study comprising a 3 (brochure: none, e-mail, hard copy) × 2 (national call center [NCC] contact: none, call) between-subjects design was conducted with 3646 nondonors who had scheduled their first appointment. Participants in the brochure conditions received either a hard copy or an e-mailed link to electronic materials modeled on the donor preparation research of France and colleagues. Participants in the NCC call condition also received a call scripted in line with these preparation materials. The key outcome was new donor attendance rate. Although first-appointment attendance rates were high in the control (no additional contact) condition at 85.07% of those not canceling in advance, dual exposure to the preparation materials through a NCC call and an electronic brochure boosted attendance. The relative risk of attending in the NCC call and electronic brochure condition was 1.0836 (95% confidence interval, 1.0352-1.1343; p = 0.0006), with attendance 8.36% higher than in the control. This gain in attendance came at a relative increase in recruitment costs of 2%. The use of tailored communication to address new donors' concerns and prepare them for donating bolsters attendance rates. © 2016 AABB.

Enhanced subgenual cingulate response to altruistic decisions in remitted major depressive disorder

PubMed Central

Pulcu, Erdem; Zahn, Roland; Moll, Jorge; Trotter, Paula D.; Thomas, Emma J.; Juhasz, Gabriella; Deakin, J.F.William; Anderson, Ian M.; Sahakian, Barbara J.; Elliott, Rebecca

2014-01-01

Background Major depressive disorder (MDD) is associated with functional abnormalities in fronto-meso-limbic networks contributing to decision-making, affective and reward processing impairments. Such functional disturbances may underlie a tendency for enhanced altruism driven by empathy-based guilt observed in some patients. However, despite the relevance of altruistic decisions to understanding vulnerability, as well as everyday psychosocial functioning, in MDD, their functional neuroanatomy is unknown. Methods Using a charitable donations experiment with fMRI, we compared 14 medication-free participants with fully remitted MDD and 15 demographically-matched control participants without MDD. Results Compared with the control group, the remitted MDD group exhibited enhanced BOLD response in a septal/subgenual cingulate cortex (sgACC) region for charitable donation relative to receiving simple rewards and higher striatum activation for both charitable donation and simple reward relative to a low level baseline. The groups did not differ in demographics, frequency of donations or response times, demonstrating only a difference in neural architecture. Conclusions We showed that altruistic decisions probe residual sgACC hypersensitivity in MDD even after symptoms are fully remitted. The sgACC has previously been shown to be associated with guilt which promotes altruistic decisions. In contrast, the striatum showed common activation to both simple and altruistic rewards and could be involved in the so-called “warm glow” of donation. Enhanced neural response in the depression group, in areas previously linked to altruistic decisions, supports the hypothesis of a possible association between hyper-altruism and depression vulnerability, as shown by recent epidemiological studies. PMID:24936421

A systematic review of training programmes for recruiters to randomised controlled trials.

PubMed

Townsend, Daisy; Mills, Nicola; Savović, Jelena; Donovan, Jenny L

2015-09-28

Recruitment to randomised controlled trials (RCTs) is often difficult. Clinician related factors have been implicated as important reasons for low rates of recruitment. Clinicians (doctors and other health professionals) can experience discomfort with some underlying principles of RCTs and experience difficulties in conveying them positively to potential trial participants. Recruiter training has been suggested to address identified problems but a synthesis of this research is lacking. The aim of our study was to systematically review the available evidence on training interventions for recruiters to randomised trials. Studies that evaluated training programmes for trial recruiters were included. Those that provided only general communication training not linked to RCT recruitment were excluded. Data extraction and quality assessment were completed by two reviewers independently, with a third author where necessary. Seventeen studies of 9615 potentially eligible titles and abstracts were included in the review: three randomised controlled studies, two non-randomised controlled studies, nine uncontrolled pre-test/post-test studies, two qualitative studies, and a post-training questionnaire survey. Most studies were of moderate or weak quality. Training programmes were mostly set within cancer trials, and usually consisted of workshops with a mix of health professionals over one or two consecutive days covering generic and trial specific issues. Recruiter training programmes were well received and some increased recruiters' self-confidence in communicating key RCT concepts to patients. There was, however, little evidence that this training increased actual recruitment rates or patient understanding, satisfaction, or levels of informed consent. There is a need to develop recruiter training programmes that can lead to improved recruitment and informed consent in randomised trials.

Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: a protocol for a randomised controlled feasibility trial.

PubMed

Oblasser, Claudia; McCourt, Christine; Hanzal, Engelbert; Christie, Janice

2016-04-01

This paper presents a feasibility trial protocol the purpose of which is to prepare for a future randomised controlled trial to determine the effectiveness of vibrating vaginal pelvic floor training balls for postpartum pelvic floor muscle rehabilitation. Vibrating vaginal pelvic floor training balls are available in Austria to enhance women's pelvic floor muscles and thus prevent or treat urinary incontinence and other pelvic floor problems following childbirth. Nonetheless, there is currently little empirical knowledge to substantiate their use or assess their relative effectiveness in comparison to current standard care, which involves pelvic floor muscle exercises. Single blind, randomised controlled feasibility trial with two parallel groups. It is planned to recruit 56 postpartum women in Vienna, who will be randomised into one of two intervention groups to use either vibrating vaginal balls or a comparator pelvic floor muscle exercises for 12 weeks. As this is a feasibility study, study design features (recruitment, selection, randomisation, intervention concordance, data collection methods and tools) will be assessed and participants' views and experiences will be surveyed. Tested outcome measures, collected before and after the intervention, will be pelvic floor muscle performance as reported by participants and measured by perineometry. Descriptive and inferential statistics and content analysis will serve the preparation of the future trial. The results of this feasibility trial will inform the design and conduct of a full randomised controlled trial and provide insight into the experiences of women regarding the interventions and study participation. © 2015 John Wiley & Sons Ltd.

Outcomes in a Randomised Controlled Trial of Mathematics Tutoring

ERIC Educational Resources Information Center

Topping, K. J.; Miller, D.; Murray, P.; Henderson, S.; Fortuna, C.; Conlin, N.

2011-01-01

Background: Large-scale randomised controlled trials (RCT) are relatively rare in education. The present study was an attempt to scale up previous small peer tutoring projects, while investing only modestly in continuing professional development for teachers. Purpose: A two-year RCT of peer tutoring in mathematics was undertaken in one local…

Can exercise improve self esteem in children and young people? A systematic review of randomised controlled trials

PubMed Central

Ekeland, E; Heian, F; Hagen, K; Coren, E

2005-01-01

Twenty three randomised controlled trials were analysed. A synthesis of several small, low quality trials indicates that exercise may have short term beneficial effects on self esteem in children and adolescents. However, high quality research on defined populations with adequate follow up is needed. PMID:16244186

Implementing Randomised Control Trials in Open and Distance Learning: A Feasibility Study

ERIC Educational Resources Information Center

Herodotou, Christothea; Heiser, Sarah; Rienties, Bart

2017-01-01

Randomised control trials (RCTs) are an evidence-based research approach which has not yet been adopted and widely used in open and distance education to inform educational policy and practice. Despite the challenges entailed in their application, RCTs hold the power to robustly evaluate the effects of educational interventions in distance…

Reading and Language Intervention for Children at Risk of Dyslexia: A Randomised Controlled Trial

ERIC Educational Resources Information Center

Duff, Fiona J.; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J.; Miles, Jeremy N. V.; Snowling, Margaret J.

2014-01-01

Background: Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. Methods: This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children…

Elementary Science Teachers' Integration of Engineering Design into Science Instruction: Results from a Randomised Controlled Trial

ERIC Educational Resources Information Center

Maeng, Jennifer L.; Whitworth, Brooke A.; Gonczi, Amanda L.; Navy, Shannon L.; Wheeler, Lindsay B.

2017-01-01

This randomised controlled trial used a mixed-methods approach to investigate the frequency and how elementary teachers integrated engineering design (ED) principles into their science instruction following professional development (PD). The ED components of the PD were aligned with Cunningham and Carlsen's [(2014). "Teaching engineering…

Skills Training to Avoid Inadvertent Plagiarism: Results from a Randomised Control Study

ERIC Educational Resources Information Center

Newton, Fiona J.; Wright, Jill D.; Newton, Joshua D.

2014-01-01

Plagiarism continues to be a concern within academic institutions. The current study utilised a randomised control trial of 137 new entry tertiary students to assess the efficacy of a scalable short training session on paraphrasing, patch writing and plagiarism. The results indicate that the training significantly enhanced students' overall…

It's up to you: a multi-message, phased driver facility campaign to increase organ donation registration rates in Illinois.

PubMed

Quick, Brian; Harrison, Tyler R; King, Andy J; Bosch, Dave

2013-01-01

The present project applied successful strategies employed in previous driver facility campaigns occurring during the inception of a registry to examine whether these approaches are effective in growing a mature registry, a registry where the majority of individuals have had the opportunity to register as an organ donor. Driver facilities (N = 40) in Illinois with high (n = 20) and low (n = 20) organ donation registration percentages were selected and served as either intervention or control sites for the campaign. Among facilities with historically high and low registration percentages, support for the campaign was found with the intervention facilities experiencing higher organ donation registration rates compared with control facilities. In addition, the results provide partial support for the effectiveness of employing a multi-message, phased driver facility intervention in states with a mature registry. The practical implications of utilizing driver facility campaigns in states with an established first-person consent registry also are discussed. © 2013 John Wiley & Sons A/S.

Therapeutic touch for anxiety disorders.

PubMed

Robinson, J; Biley, F C; Dolk, H

2007-07-18

Anxiety disorders are a common occurrence in today's society. There is interest from the community in the use of complementary therapies for anxiety disorders. This review examined the currently available evidence supporting the use of therapeutic touch in treating anxiety disorders. To examine the efficacy and adverse effects of therapeutic touch for anxiety disorders. We searched the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Registers (CCDANCTR-Studies and CCDANCTR-References) (search date 13/01/06), the Controlled Trials website and Dissertation Abstracts International. Searches of reference lists of retrieved papers were also carried out and experts in the field were contacted. Inclusion criteria included all published and unpublished randomised and quasi-randomised controlled trials comparing therapeutic touch with sham (mimic) TT, pharmacological therapy, psychological treatment, other treatment or no treatment /waiting list. The participants included adults with an anxiety disorder defined by the Diagnostic and Statistical Manual (DSM-IV),the International Classification of Diseases (ICD-10), validated diagnostic instruments, or other validated clinician or self-report instruments. Two review authors independently applied inclusion criteria. Further information was sought from trialists where papers contained insufficient information to make a decision about eligibility. No randomised or quasi-randomised controlled trials of therapeutic touch for anxiety disorders were identified. Given the high prevalence of anxiety disorders and the current paucity of evidence on therapeutic touch in this population, there is a need for well conducted randomised controlled trials to examine the effectiveness of therapeutic touch for anxiety disorders.

Vitamin K for upper gastrointestinal bleeding in people with acute or chronic liver diseases.

PubMed

Martí-Carvajal, Arturo J; Solà, Ivan

2015-06-09

Upper gastrointestinal bleeding is one of the most frequent causes of morbidity and mortality in the course of liver cirrhosis. Several treatments are used for upper gastrointestinal bleeding in people with liver diseases. One of them is vitamin K administration, but it is not known whether it benefits or harms people with acute or chronic liver disease and upper gastrointestinal bleeding. This is an update of this Cochrane review. To assess the beneficial and harmful effects of vitamin K for people with acute or chronic liver disease and upper gastrointestinal bleeding. We searched The Cochrane Hepato-Biliary Controlled Trials Register (February 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2 of 12, 2015), MEDLINE (Ovid SP) (1946 to February 2015), EMBASE (Ovid SP) (1974 to February 2015), Science Citation Index EXPANDED (1900 to February 2015), and LILACS (1982 to 25 February 2015). We sought additional randomised trials from two registries of clinical trials: the World Health Organization Clinical Trials Search Portal and the metaRegister of Controlled Trials. We looked through the reference lists of the retrieved publications and review articles. Randomised clinical trials irrespective of blinding, language, or publication status for assessment of benefits and harms. We considered observational studies for assessment of harms only. \\We aimed to summarise data from randomised clinical trials using Standard Cochrane methodology and assess them according to the GRADE approach. We found no randomised trials on vitamin K for upper gastrointestinal bleeding in people with liver diseases assessing benefits and harms of the intervention. We identified no quasi-randomised studies, historically controlled studies, or observational studies assessing harms. This updated review found no randomised clinical trials of vitamin K for upper gastrointestinal bleeding in people with liver diseases. The benefits and harms of vitamin K need to be tested in randomised clinical trials. Until randomised clinical trials are conducted to assess the trade-off between benefits and harms, we cannot recommend or refute the use of vitamin K for upper gastrointestinal bleeding in people with liver diseases.

Systematic review with meta-analysis: Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea.

PubMed

Szajewska, H; Kołodziej, M

2015-10-01

Antibiotic-associated diarrhoea is a common complication of antibiotic use, but it can be prevented with administration of probiotics. To update our 2005 meta-analysis on the effectiveness of Saccharomyces boulardii in preventing antibiotic-associated diarrhoea in children and adults. The Cochrane Library, MEDLINE, and EMBASE databases were searched up until May 2015, with no language restrictions, for randomised controlled trials; additional references were obtained from reviewed articles. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines. Twenty-one randomised controlled trials (4780 participants), among which 16 were new trials, met the inclusion criteria for this updated systematic review. Administration of S. boulardii compared with placebo or no treatment reduced the risk of antibiotic-associated diarrhoea (as defined by the study investigators) in patients treated with antibiotics from 18.7% to 8.5% (risk ratio, RR: 0.47; 95% CI: 0.38-0.57, number needed to treat, NNT: 10; 95% CI: 9-13). In children, S. boulardii reduced the risk from 20.9% to 8.8% (6 randomised controlled trials, n=1653, RR: 0.43, 95% CI: 0.3-0.6); in adults, from 17.4% to 8.2% (15 randomised controlled trials, n=3114, RR: 0.49, 95% CI: 0.38-0.63). Moreover, S. boulardii reduced the risk of Clostridium difficile-associated diarrhoea; however, this reduction was significant only in children (2 randomised controlled trials, n = 579, RR: 0.25; 95% CI: 0.08-0.73) and not in adults (9 randomised controlled trials, n = 1441, RR: 0.8, 95% CI: 0.47-1.34). This meta-analysis confirms that S. boulardii is effective in reducing the risk of antibiotic-associated diarrhoea in children and adults. © 2015 John Wiley & Sons Ltd.

Study protocol of a multicentre randomised controlled trial of self-help cognitive behaviour therapy for working women with menopausal symptoms (MENOS@Work).

PubMed

Hunter, Myra S; Hardy, Claire; Norton, Sam; Griffiths, Amanda

2016-10-01

Hot flushes and night sweats (HFNS) - the main symptoms of the menopause transition - can reduce quality of life and are particularly difficult to manage at work. A cognitive behaviour therapy (CBT) intervention has been developed specifically for HFNS that is theoretically based and shown to reduce significantly the impact of HFNS in several randomised controlled trials (RCTs). Self-help CBT has been found to be as effective as group CBT for these symptoms, but these interventions are not widely available in the workplace. This paper describes the protocol of an RCT aiming to assess the efficacy of CBT for menopausal symptoms implemented in the workplace, with a nested qualitative study to examine acceptability and feasibility. One hundred menopausal working women, aged 45-60 years, experiencing bothersome HFNS for two months will be recruited from several (2-10) large organisations into a multicentre randomised controlled trial. Women will be randomly assigned to either treatment (a self-help CBT intervention lasting 4 weeks) or to a no treatment-wait control condition (NTWC), following a screening interview, consent, and completion of a baseline questionnaire. All participants will complete follow-up questionnaires at 6 weeks and 20 weeks post-randomisation. The primary outcome is the rating of HFNS; secondary measures include HFNS frequency, mood, quality of life, attitudes to menopause, HFNS beliefs and behaviours, work absence and presenteeism, job satisfaction, job stress, job performance, disclosure to managers and turnover intention. Adherence, acceptability and feasibility will be assessed at 20 weeks post-randomisation in questionnaires and qualitative interviews. Upon trial completion, the control group will also be offered the intervention. This is the first randomised controlled trial of a self-management intervention tailored for working women who have troublesome menopausal symptoms. Clin.Gov NCT02623374. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.

PubMed

Glazener, Cathryn; Constable, Lynda; Hemming, Christine; Breeman, Suzanne; Elders, Andrew; Cooper, Kevin; Freeman, Robert; Smith, Anthony R B; Hagen, Suzanne; McDonald, Alison; McPherson, Gladys; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; Goulao, Beatriz; Norrie, John

2016-09-08

One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events. VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation. Demonstrating the efficacy of vault and uterine prolapse surgeries is relevant not only to patients and clinicians but also to health care providers, both in the UK and globally. Current controlled trials ISRCTN86784244 (assigned 19 October 2012), and the first subject was randomly assigned on 1 May 2013.

Diamorphine for pain relief in labour : a randomised controlled trial comparing intramuscular injection and patient-controlled analgesia.

PubMed

McInnes, Rhona J; Hillan, Edith; Clark, Diana; Gilmour, Harper

2004-10-01

To compare the efficacy of diamorphine administered by a patient-controlled pump (patient-controlled analgesia) with intramuscular administration for pain relief in labour. Randomised controlled trial. The South Glasgow University Hospitals NHS Trust. Primigravidae and multigravidae in labour at term (37-42 weeks). Women were randomised in labour to the study (patient-controlled analgesia) or control group (intramuscular). Randomisation was achieved through a random permuted block design stratified by parity. Study group women were given a loading dose of 1.2 mg diamorphine intravenously and then attached to the pump. Control group women received intramuscular diamorphine as per hospital protocol. Participants were also given 3 mg of buccal Stemetil. Data were collected throughout labour and at six postnatal weeks. Analgesia requirements during labour and women's satisfaction with the method of pain relief. Women in the study group (patient-controlled analgesia) used significantly less diamorphine than women in the control group (intramuscular) but were significantly more likely to state that they were very dissatisfied with their use of diamorphine and were significantly more likely to opt out of the trial before the birth of the baby. The majority of women in both groups used other analgesia concurrent with diamorphine such as Entonox, aromatherapy or TENS. Patient-controlled analgesia administration of diamorphine for the relief of pain in labour offers no significant advantages over intramuscular administration. The results also suggest that diamorphine is a poor analgesic for labour pain irrespective of the mode of administration.

Theory of planned behaviour variables and objective walking behaviour do not show seasonal variation in a randomised controlled trial.

PubMed

Williams, Stefanie L; French, David P

2014-02-05

Longitudinal studies have shown that objectively measured walking behaviour is subject to seasonal variation, with people walking more in summer compared to winter. Seasonality therefore may have the potential to bias the results of randomised controlled trials if there are not adequate statistical or design controls. Despite this there are no studies that assess the impact of seasonality on walking behaviour in a randomised controlled trial, to quantify the extent of such bias. Further there have been no studies assessing how season impacts on the psychological predictors of walking behaviour to date. The aim of the present study was to assess seasonal differences in a) objective walking behaviour and b) Theory of Planned Behaviour (TPB) variables during a randomised controlled trial of an intervention to promote walking. 315 patients were recruited to a two-arm cluster randomised controlled trial of an intervention to promote walking in primary care. A series of repeated measures ANCOVAs were conducted to examine the effect of season on pedometer measures of walking behaviour and TPB measures, assessed immediately post-intervention and six months later. Hierarchical regression analyses were conducted to assess whether season moderated the prediction of intention and behaviour by TPB measures. There were no significant differences in time spent walking in spring/summer compared to autumn/winter. There was no significant seasonal variation in most TPB variables, although the belief that there will be good weather was significantly higher in spring/summer (F = 19.46, p < .001). Season did not significantly predict intention or objective walking behaviour, or moderate the effects of TPB variables on intention or behaviour. Seasonality does not influence objectively measured walking behaviour or psychological variables during a randomised controlled trial. Consequently physical activity behaviour outcomes in trials will not be biased by the season in which they are measured. Previous studies may have overestimated the extent of seasonality effects by selecting the most extreme summer and winter months to assess PA. In addition, participants recruited to behaviour change interventions might have higher levels of motivation to change and are less affected by seasonal barriers. Current Controlled Trials ISRCTN95932902.

Efficacy of vitamin and antioxidant supplements in prevention of cardiovascular disease: systematic review and meta-analysis of randomised controlled trials

PubMed Central

Ju, Woong; Oh, Seung-Won; Park, Sang Min; Koo, Bon-Kwon; Park, Byung-Joo

2013-01-01

Objective To assess the efficacy of vitamin and antioxidant supplements in the prevention of cardiovascular diseases. Design Meta-analysis of randomised controlled trials. Data sources and study selection PubMed, EMBASE, the Cochrane Library, Scopus, CINAHL, and ClinicalTrials.gov searched in June and November 2012. Two authors independently reviewed and selected eligible randomised controlled trials, based on predetermined selection criteria. Results Out of 2240 articles retrieved from databases and relevant bibliographies, 50 randomised controlled trials with 294 478 participants (156 663 in intervention groups and 137 815 in control groups) were included in the final analyses. In a fixed effect meta-analysis of the 50 trials, supplementation with vitamins and antioxidants was not associated with reductions in the risk of major cardiovascular events (relative risk 1.00, 95% confidence interval 0.98 to 1.02; I2=42%). Overall, there was no beneficial effect of these supplements in the subgroup meta-analyses by type of prevention, type of vitamins and antioxidants, type of cardiovascular outcomes, study design, methodological quality, duration of treatment, funding source, provider of supplements, type of control, number of participants in each trial, and supplements given singly or in combination with other supplements. Among the subgroup meta-analyses by type of cardiovascular outcomes, vitamin and antioxidant supplementation was associated with a marginally increased risk of angina pectoris, while low dose vitamin B6 supplementation was associated with a slightly decreased risk of major cardiovascular events. Those beneficial or harmful effects disappeared in subgroup meta-analysis of high quality randomised controlled trials within each category. Also, even though supplementation with vitamin B6 was associated with a decreased risk of cardiovascular death in high quality trials, and vitamin E supplementation with a decreased risk of myocardial infarction, those beneficial effects were seen only in randomised controlled trials in which the supplements were supplied by the pharmaceutical industry. Conclusion There is no evidence to support the use of vitamin and antioxidant supplements for prevention of cardiovascular diseases. PMID:23335472

The clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people attending sexual health clinics: a randomised controlled trial

PubMed Central

Crawford, Mike J; Sanatinia, Rahil; Barrett, Barbara; Byford, Sarah; Dean, Madeleine; Green, John; Jones, Rachael; Leurent, Baptiste; Sweeting, Michael J; Touquet, Robin; Greene, Linda; Tyrer, Peter; Ward, Helen; Lingford-Hughes, Anne

2015-01-01

Objectives To examine the clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people who attend sexual health clinics. Methods Two-arm, parallel group, assessor blind, pragmatic, randomised controlled trial. 802 people aged 19 years or over who attended one of three sexual health clinics and were drinking excessively were randomised to either brief advice or control treatment. Brief advice consisted of feedback on alcohol and health, written information and an offer of an appointment with an Alcohol Health Worker. Control participants received a leaflet on health and lifestyle. The primary outcome was mean weekly alcohol consumption during the previous 90 days measured 6 months after randomisation. The main secondary outcome was unprotected sex during this period. Results Among the 402 randomised to brief advice, 397 (99%) received it. The adjusted mean difference in alcohol consumption at 6 months was −2.33 units per week (95% CI −4.69 to 0.03, p=0.053) among those in the active compared to the control arm of the trial. Unprotected sex was reported by 154 (53%) of those who received brief advice, and 178 (59%) controls (adjusted OR=0.89, 95% CI 0.63 to 1.25, p=0.496). There were no significant differences in costs between study groups at 6 months. Conclusions Introduction of universal screening and brief advice for excessive alcohol use among people attending sexual health clinics does not result in clinically important reductions in alcohol consumption or provide a cost-effective use of resources. Trial registration number Current Controlled Trials ISRCTN 99963322. PMID:24936090

Palliative care consultation in the process of organ donation after cardiac death.

PubMed

Kelso, Catherine McVearry; Lyckholm, Laurie J; Coyne, Patrick J; Smith, Thomas J

2007-02-01

Palliative care consultation has been demonstrated to be useful in many situations in which expert symptom management, communication around sensitive issues, and family support may serve to enhance or improve care. The process of organ donation is an example of this concept, specifically the process of donation after cardiac death (DCD). DCD allows patients with severe, irreversible brain injuries that do not meet standard criteria for brain death to donate organs when death is declared by cardiopulmonary criteria. The DCD method of donation has been deemed an ethically appropriate means of organ donation and is supported by the organ procurement and medical communities, as well as the public. The palliative care (PC) team can make a significant contribution to the care of the patient and family in the organ donation process. In this paper we describe the controlled DCD process at one institution that utilizes the PC team to provide expert end-of-life care, including comprehensive medical management and family support. PC skills and principles applicable to the DCD process include communication, coordination of care, and skillful ventilator withdrawal. If death occurs within 90 minutes of withdrawal of life support, organs may be successfully recovered for transplantation. If the patient survives longer than 90 minutes, his or her care continues to be provided by the PC team. Palliative care can contribute to standardizing quality end-of-life care practices in the DCD process and provide education for involved personnel. Further experience, research and national discussions will be helpful in refining these practices, to make this difficult and challenging experience as gentle and supportive as possible for the courageous families who participate in this process.

Breastmilk donations: Bacteriological assessment, analysis of causes of non-compliance and suggestions for improvement.

PubMed

Mullié, C; Obin, O; Outurquin, G; Grognet, S; Léké, A; Adjidé, C

2018-05-01

A total of 1099 breastmilk donations received by the milk bank at the Amiens University Hospital from January to June 2016 were assessed for bacteriological contamination according to French regulations. This consisted in enumerating the total aerobic flora before and after heat treatment as well as the specific enumeration of coagulase-positive staphylococci. Results above the mandatory limits for at least one of these parameters were found in 25.9% of the donations, resulting in the destruction of approximately one-quarter of the volume of the donations (∼195L). This is a huge loss in both economic and health-related terms for neonates, especially for pre-terms. To identify ways to improve the bacteriological assessment results and reduce the percentage of discarded milk, an analysis of the causes was conducted. The two main causes of non-compliance were the detection of a cultivable aerobic flora after heat treatment and the presence of coagulase-positive staphylococci above the mandatory limit (11.7% and 11.2% of the tested donations, respectively). Bacillus spp. were the leading cause of post-heat-treatment non-compliance. Therefore, the implementation of better environmental control could help reduce this kind of contamination. As for samples harboring coagulase-positive staphylococci, a further detection of toxins using molecular biology techniques could help discriminate actual health-hazardous donations that have to be destroyed while enabling the use of toxin-negative donations. Nevertheless, the economic viability of this proposal needs to be further assessed because these techniques are costly. Finally, a change in breastmilk dilutions used to enumerate the total aerobic flora to better reflect the actual level of these bacteria in the milk was proposed. Indeed, the comparison of various combinations of milk dilutions led to the conclusion that the association of the 1/10 and 1/100 dilutions was the best compromise between technical ease of enumeration and ensuring the safety of the donations. Implementing these suggestions would help reduce the rate of non-compliance and give better access to safe breastmilk donations for neonates. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Review of Randomised Controlled Trials of Internet Interventions for Mental Disorders and Related Conditions

ERIC Educational Resources Information Center

Griffiths, Kathleen M.; Christensen, Helen

2006-01-01

Self-help Internet interventions have the potential to enable consumers to play a central role in managing their own health. This paper contains a systematic review of 15 randomised controlled trials of the effectiveness of self-help Internet interventions for mental disorders and related conditions. Conditions addressed by the interventions…

Representation of People with Intellectual Disabilities in Randomised Controlled Trials on Antipsychotic Treatment for Behavioural Problems

ERIC Educational Resources Information Center

Scheifes, A.; Stolker, J. J.; Egberts, A. C. G.; Nijman, H. L. I.; Heerdink, E. R.

2011-01-01

Background: Behavioural problems are common in people with intellectual disability (ID) and are often treated with antipsychotics. Aim: To establish the frequency and characteristics of people with ID included in randomised controlled trials (RCTs) on antipsychotic treatment for behavioural problems, and to investigate the quality of these RCTs.…

Effect of a Universal Anxiety Prevention Programme (FRIENDS) on Children's Academic Performance: Results from a Randomised Controlled Trial

ERIC Educational Resources Information Center

Skryabina, Elena; Taylor, Gordon; Stallard, Paul

2016-01-01

Background: Evaluations of school-based anxiety prevention programmes have reported improvements in psychological functioning although little is known about their effect upon educational outcomes. Methods: One thousand three hundred and sixty-two children from 40 primary schools in England took part in the randomised controlled trial, Preventing…

A Randomised Controlled Trial to Determine the Effectiveness of an Early Psychological Intervention with Children Involved in Road Traffic Accidents

ERIC Educational Resources Information Center

Stallard, Paul; Velleman, Richard; Salter, Emma; Howse, Imogen; Yule, William; Taylor, Gordon

2006-01-01

Objective: To determine whether an early intervention using a psychological debriefing format is effective in preventing psychological distress in child road traffic accident survivors. Design: Randomised controlled trial. Setting: Accident and Emergency Department, Royal United Hospital, Bath. Subjects: 158 children aged 7-18. Follow-up…

The Effectiveness of Picture Exchange Communication System (PECS) Training for Teachers of Children with Autism: A Pragmatic, Group Randomised Controlled Trial

ERIC Educational Resources Information Center

Howlin, Patricia; Gordon, R. Kate; Pasco, Greg; Wade, Angie; Charman, Tony

2007-01-01

Objective: To assess the effectiveness of expert training and consultancy for teachers of children with autism spectrum disorder in the use of the Picture Exchange Communication System (PECS). Method: Design: Group randomised, controlled trial (3 groups: immediate treatment, delayed treatment, no treatment). Participants: 84 elementary school…

"Every Child Counts": Testing Policy Effectiveness Using a Randomised Controlled Trial, Designed, Conducted and Reported to CONSORT Standards

ERIC Educational Resources Information Center

Torgerson, Carole; Wiggins, Andy; Torgerson, David; Ainsworth, Hannah; Hewitt, Catherine

2013-01-01

We report a randomised controlled trial evaluation of an intensive one-to-one numeracy programme--"Numbers Count"--which formed part of the previous government's numeracy policy intervention--"Every Child Counts." We rigorously designed and conducted the trial to CONSORT guidelines. We used a pragmatic waiting list design to…

Intelligence and Persisting with Medication for Two Years: Analysis in a Randomised Controlled Trial

ERIC Educational Resources Information Center

Deary, Ian J.; Gale, Catharine R.; Stewart, Marlene C. W.; Fowkes, F. Gerald R.; Murray, Gordon D.; Batty, G. David; Price, Jacqueline F.

2009-01-01

The study examined whether verbal intelligence is associated with persisting to take medication for up to two years. The design is a prospective follow-up of compliance with taking medication in high-risk individuals participating in a randomised, placebo-controlled trial set in Central Scotland. Participants were 1993 people aged between 50 and…

Stress in Fathers of Moderately and Late Preterm Infants: A Randomised Controlled Trial

ERIC Educational Resources Information Center

Ravn, Ingrid Helen; Lindemann, Rolf; Smeby, Nina Aarhus; Bunch, Eli Haugen; Sandvik, Leiv; Smith, Lars

2012-01-01

The atypical behaviour of preterm infants can elicit stress in fathers and influence their ability to perceive and interpret infants' cues. This study investigated whether fathers of moderately and late preterm infants were more stressed than fathers of term infants. In a randomised controlled trial, we also studied the effect of the Mother-Infant…

Can Healthcare Assistant Training (CHAT) improve the relational care of older people? Study protocol for a pilot cluster randomised controlled trial.

PubMed

Arthur, Antony; Maben, Jill; Wharrad, Heather; Aldus, Clare; Sarre, Sophie; Schneider, Justine; Nicholson, Caroline; Barton, Garry; Cox, Karen; Clark, Allan

2015-12-09

People aged 75 years and over account for 1 in 4 of all hospital admissions. There has been increasing recognition of problems in the care of older people, particularly in hospitals. Evidence suggests that older people judge the care they receive in terms of kindness, empathy, compassion, respectful communication and being seen as a person not just a patient. These are aspects of care to which we refer when we use the term 'relational care'. Healthcare assistants deliver an increasing proportion of direct care to older people, yet their training needs are often overlooked. This study will determine the acceptability and feasibility of a cluster randomised controlled trial of 'Older People's Shoes' a 2-day training intervention for healthcare assistants caring for older people in hospital. Within this pilot, 2-arm, parallel, cluster randomised controlled trial, healthcare assistants within acute hospital wards are randomised to either the 2-day training intervention or training as usual. Registered nurses deliver 'Older People's Shoes' over 2 days, approximately 1 week apart. It contains three components: experiential learning about ageing, exploration of older people's stories, and customer care. Outcomes will be measured at the level of patient (experience of emotional care and quality of life during their hospital stay), healthcare assistant (empathy and attitudes towards older people), and ward (quality of staff/patient interaction). Semi-structured interviews of a purposive sample of healthcare assistants receiving the intervention, and all trainers delivering the intervention, will be undertaken to gain insights into the experiences of both the intervention and the trial, and its perceived impact on practice. Few training interventions for care staff have been rigorously tested using randomised designs. This study will establish the viability of a definitive cluster randomised controlled trial of a new training intervention to improve the relational care proided by healthcare assistants working with older people in hospital. The study was registered as an International Standard Randomised Controlled Trial ( ISRCTN10385799 ) on 29 December 2014.

The "ick" factor, anticipated regret, and willingness to become an organ donor.

PubMed

O'Carroll, Ronan E; Foster, Catherine; McGeechan, Grant; Sandford, Kayleigh; Ferguson, Eamonn

2011-03-01

This research tested the role of traditional rational-cognitive factors and emotional barriers to posthumous organ donation. An example of an emotional barrier is the "ick" factor, a basic disgust reaction to the idea of organ donation. We also tested the potential role of manipulating anticipated regret to increase intention to donate in people who are not yet registered organ donors. In three experiments involving 621 members of the United Kingdom general public, participants were invited to complete questionnaire measures tapping potential emotional affective attitude barriers such as the "ick" factor, the desire to retain bodily integrity after death, and medical mistrust. Registered posthumous organ donors were compared with nondonors. In Experiments 2 and 3, nondonors were then allocated to a simple anticipated regret manipulation versus a control condition, and the impact on intention to donate was tested. Self-reported emotional barriers and intention to donate in the future. Traditional rational-cognitive factors such as knowledge, attitude, and subjective norm failed to distinguish donors from nondonors. However, in all three experiments, nondonors scored significantly higher than donors on the emotional "ick" factor and bodily integrity scales. A simple anticipated regret manipulation led to a significant increase in intention to register as an organ donor in future. Negative affective attitudes are thus crucial barriers to people registering as organ donors. A simple anticipated regret manipulation has the potential to significantly increase organ donation rates. (c) 2011 APA, all rights reserved

[Commitment in plasmapheresis donation: A study of determinants among regular donors in plasmapheresis].

PubMed

Delépine-Farvacques, S; Terrade, Florence; Danic, B; Lebaudy, J-P

2017-06-01

The purpose of this study, based on the Theory of planned behavior, is to identify and ultimately better understand what determines the fidelity and the regularity of donors committed in plasmapheresis donation. This qualitative study is a primary stage to establish a classification of donors in a French socio-cultural context. For this reason, we have carried out a survey among 16 regular plasmapheresis donors, by way of semi-structured individual interviews at the Établissement français du sang - Brittany. The level of commitment of these regular donors is considered as a level of appropriation. If subjective norms have initially influenced their decision to donate blood, no specific motivation has been highlighted for them to donate plasma except a generally favourable attitude towards the voluntary donation process. The perception of control over their environment is a variable which played a decisive role in the donor's intention to give, with little cost associated to plasmapheresis donation and recourse to internal causal explanations. A better comprehension of the plasmapheresis donors' determinants should lead us to a more efficient awareness of new potential donors, thereby enhancing recruitment and retention. Due to the increasing need for plasma-derived products, this study's ultimate issue is closely correlated both with ethical and socio-economic aspects. Following which, after analysing the results, a certain number of recommendations will be made. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Canadian Guidelines for Controlled Pediatric Donation After Circulatory Determination of Death—Summary Report*

PubMed Central

Hornby, Laura; Rochwerg, Bram; van Manen, Michael; Dhanani, ; Sonny; Sivarajan, V. Ben; Appleby, Amber; Bennett, Mary; Buchman, Daniel; Farrell, Catherine; Goldberg, Aviva; Greenberg, Rebecca; Singh, Ram; Nakagawa, Thomas A.; Witteman, William; Barter, Jill; Beck, Allon; Coughlin, Kevin; Conradi, Alf; Cupido, Cynthia; Dawson, Rosanne; Dipchand, Anne; Freed, Darren; Hornby, Karen; Langlois, Valerie; Mack, Cheryl; Mahoney, Meagan; Manhas, Deepak; Tomlinson, Christopher; Zavalkoff, Samara; Shemie, Sam D.

2017-01-01

Objectives: Create trustworthy, rigorous, national clinical practice guidelines for the practice of pediatric donation after circulatory determination of death in Canada. Methods: We followed a process of clinical practice guideline development based on World Health Organization and Canadian Medical Association methods. This included application of Grading of Recommendations Assessment, Development, and Evaluation methodology. Questions requiring recommendations were generated based on 1) 2006 Canadian donation after circulatory determination of death guidelines (not pediatric specific), 2) a multidisciplinary symposium of national and international pediatric donation after circulatory determination of death leaders, and 3) a scoping review of the pediatric donation after circulatory determination of death literature. Input from these sources drove drafting of actionable questions and Good Practice Statements, as defined by the Grading of Recommendations Assessment, Development, and Evaluation group. We performed additional literature reviews for all actionable questions. Evidence was assessed for quality using Grading of Recommendations Assessment, Development, and Evaluation and then formulated into evidence profiles that informed recommendations through the evidence-to-decision framework. Recommendations were revised through consensus among members of seven topic-specific working groups and finalized during meetings of working group leads and the planning committee. External review was provided by pediatric, critical care, and critical care nursing professional societies and patient partners. Results: We generated 63 Good Practice Statements and seven Grading of Recommendations Assessment, Development, and Evaluation recommendations covering 1) ethics, consent, and withdrawal of life-sustaining therapy, 2) eligibility, 3) withdrawal of life-sustaining therapy practices, 4) ante and postmortem interventions, 5) death determination, 6) neonatal pediatric donation after circulatory determination of death, 7) cardiac and innovative pediatric donation after circulatory determination of death, and 8) implementation. For brevity, 48 Good Practice Statement and truncated justification are included in this summary report. The remaining recommendations, detailed methodology, full Grading of Recommendations Assessment, Development, and Evaluation tables, and expanded justifications are available in the full text report. Conclusions: This process showed that rigorous, transparent clinical practice guideline development is possible in the domain of pediatric deceased donation. Application of these recommendations will increase access to pediatric donation after circulatory determination of death across Canada and may serve as a model for future clinical practice guideline development in deceased donation. PMID:28925929

Making a case for controlled organ donation after cardiac death: the story of Italy's first experience.

PubMed

Vergano, Marco; Magavern, Emma; Baroncelli, Francesca; Frisenda, Valeria; Fonsato, Alessia; Artusio, Diego; Castioni, Carlo Alberto; De Piero, Maria Elena; Abelli, Massimo; Ticozzelli, Elena; Livigni, Sergio

2017-04-01

Donation after circulatory death (DCD) is a valuable option for the procurement of organs for transplantation. In Italy, organ procurement after controlled DCD is legally and ethically conceivable within the current legislative framework. However, although formal impediments do not exist, the health care team is faced with many obstacles that may hinder the implementation of such programs. We report the case of Italy's first controlled DCD, specifically discussing the role of the patient's family in the shared decision-making process. In our case, the death of the patient subsequent to the withdrawal of life-sustaining therapies was consistent with the patient's wishes, showing respect for his dignity and honoring his autonomy, as expressed to his family previously. By making donation possible, the medical team was able to fulfill the family's last request on behalf of the patient. This case should stimulate deliberation regarding the potential to shorten the 20-minute no-touch period currently in place in Italy. Such an action would not have injured this patient and would certainly have increased the quality of the procured organs. Copyright © 2016 Elsevier Inc. All rights reserved.

Culturally appropriate education intervention on biospecimen research participation among Chinese Americans.

PubMed

Gao, Wanzhen; Ma, Grace X; Tan, Yin; Fang, Carolyn; Weaver, Joellen; Jin, Ming; Lai, Philip; Godwin, Andrew K

2014-03-01

Chinese Americans are at increased risk for hepatitis B virus (HBV) infection. To reduce or eliminate disparities in HBV-related infection rates, participation in scientific investigations of HBV risk and treatment, including biospecimen sampling, is important. However, Asian Americans have low rates of participation in biospecimen research, and little is known about how educational interventions affect knowledge and participation in HBV-related biospecimen research. Eight Chinese community-based organizations participated in a quasi-experimental, two-group design with education assessments at pre- and postworkshop and a 3-month follow-up. Four sites were randomly assigned to receive the intervention (n = 175) and four sites to receive general health education (control; n = 240). Participant knowledge about biospecimen research increased from pre- to posteducation in the intervention but not in the control condition. Of intervention participants, 83.4% (146/175) donated one tube of blood for future HBV biospecimen research, and 50.9% (89/175) donated another tube of blood for HBV testing. In contrast, only 1.1% of participants in the control condition reported donating a blood sample at follow-up assessment. The intervention program significantly increased knowledge of and participation in HBV biospecimen research among Chinese Americans. Community-based participatory research (CBPR) methods featured active support by community leaders, a culturally specific curriculum, and convenient, immediate access to blood sampling, which resulted in high donation rates. HBV-related morbidity and mortality is an urgent problem faced by Chinese Americans. CBPR provides a model for engaging communities in early detection, vaccination, and treatment that can reduce this health threat. ©2014 AACR.

Is Decedent Race an Independent Predictor of Organ Donor Consent, or Merely a Surrogate Marker of Socioeconomic Status?

PubMed Central

DuBay, Derek A.; Redden, David; Haque, Akhlaque; Gray, Stephen; Fouad, Mona; Siminoff, Laura A.; Holt, Cheryl; Kohler, Connie; Eckhoff, Devin

2013-01-01

Background Studies have demonstrated that African American race is a strong predictor of non-donation. However, it is often and correctly argued that African American race is a crude explanatory variable that is a surrogate marker of socioeconomic status (SES), education and access to health care. We hypothesized that when controlling for these factors, African American race would cease to be a predictor of organ donation. Methods A retrospective review was performed of 1292 Alabama decedents approached for organ donation between 2006 and 2009. Multivariable logistic regression models were constructed to identify the most parsimonious model that could explain the variation in the log-odds of obtaining consent. Results Consent for donation was obtained from 49% of the decedent's families. Household income was a predictor of organ donor consent only in Caucasians. Surprisingly, household income was not statistically different between consented and non-consented African American decedents ($25,147 vs. $26,137; p=0.90). On multivariable analysis, education, urban residence and shorter distance between the decedent residence and donor hospital were significantly associated with obtaining consent for organ donation. On univariate analysis, the odds of donor consent in Caucasians compared to African Americans was 2.76 (95% CI 2.17 – 3.57). When controlling for SES and access to healthcare variables, the odds of donor consent increased to 4.36 (95% CI 2.88 – 6.61). Conclusions We interpret this result to indicate that there remains unknown but important factor(s) associated with both race and obtaining organ donor consent. Further studies are required to isolate and determine whether this factor(s) is modifiable. PMID:23018878

Demographic factors affect willingness to register as an organ donor more than a personal relationship with a transplant candidate

PubMed Central

Regalia, Kirsten; Zheng, Patricia; Sillau, Stefan; Aggarwal, Anuj; Bellevue, Oliver; Fix, Oren K.; Prinz, Jennifer; Dunn, Susan; Biggins, Scott W.

2014-01-01

Background Transplant candidate caregivers (TCCs) are an under-utilized but potentially devoted pool of advocates who themselves may be recruited to register for deceased organ donation. Aim To assess and compare recruitment barriers to deceased donor registration efforts in TCCs and health fair attendees (HFAs). Methods A 42-item questionnaire assessing willingness to register as an organ donor and perceptions and knowledge about organ donation was administered to 452 participants (174 in Denver, 278 in San Francisco). Logistic regression, stratified by study site, was used to assess associations between explanatory variables and willingness to register as an organ donor. Results In Denver, 83% of TCCs vs 68% of HFAs indicated a willingness to register (p = 0.03). Controlling for study group (TCC vs HFA), predictors of willingness to register were female gender (OR 2.4), Caucasian race (OR 2.3), college graduate (OR 11.1), married (OR 2.4) and higher positive perception of organ donation (OR 1.2), each p<0.05. In San Francisco, 58% of TCCs vs 70% of HFAs indicated a willingness to register (p = 0.03). Controlling for study group (TCC vs HFA), predictors of willingness to register were Caucasian race (OR 3.5), college graduate (OR 2.2), married (OR 1.9), higher knowledge (OR 1.6) and higher positive perception of organ donation (OR 1.2), each p<0.05. In both locales, Caucasians were more likely to have positive perceptions about organ donation and were more willing to register. Conclusions Demographic characteristics, not personal connection to a transplant candidate, explain willingness to register as an organ donor. PMID:24519521

Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial

PubMed Central

2011-01-01

Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/m2 approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between 10+0-20+0 weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/m2), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between 10+0 and 20+0 weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ 90th centile for gestational age). Sample Size: 2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 PMID:22026403

Immediate chest X-ray for patients at risk of lung cancer presenting in primary care: randomised controlled feasibility trial

PubMed Central

Neal, Richard D; Barham, Allan; Bongard, Emily; Edwards, Rhiannon Tudor; Fitzgibbon, Jim; Griffiths, Gareth; Hamilton, Willie; Hood, Kerenza; Nelson, Annmarie; Parker, David; Porter, Cath; Prout, Hayley; Roberts, Kirsty; Rogers, Trevor; Thomas-Jones, Emma; Tod, Angela; Yeo, Seow Tien; Hurt, Chris N

2017-01-01

Background: Achieving earlier stage diagnosis is one option for improving lung cancer outcomes in the United Kingdom. Patients with lung cancer typically present with symptoms to general practitioners several times before referral or investigation. Methods: We undertook a mixed methods feasibility individually randomised controlled trial (the ELCID trial) to assess the feasibility and inform the design of a definitive, fully powered, UK-wide, Phase III trial of lowering the threshold for urgent investigation of suspected lung cancer. Patients over 60, with a smoking history, presenting with new chest symptoms to primary care, were eligible to be randomised to intervention (urgent chest X-ray) or usual care. Results: The trial design and materials were acceptable to GPs and patients. We randomised 255 patients from 22 practices, although the proportion of eligible patients who participated was lower than expected. Survey responses (89%), and the fidelity of the intervention (82% patients X-rayed within 3 weeks) were good. There was slightly higher anxiety and depression in the control arm in participants aged >75. Three patients (1.2%) were diagnosed with lung cancer. Conclusions: We have demonstrated the feasibility of individually randomising patients at higher risk of lung cancer, to a trial offering urgent investigation or usual care. PMID:28072761

The Clots in Legs Or sTockings after Stroke (CLOTS) 3 trial: a randomised controlled trial to determine whether or not intermittent pneumatic compression reduces the risk of post-stroke deep vein thrombosis and to estimate its cost-effectiveness.

PubMed

Dennis, Martin; Sandercock, Peter; Graham, Catriona; Forbes, John; Smith, J

2015-09-01

Venous thromboembolism (VTE) is a common cause of death and morbidity in stroke patients. There are few data concerning the effectiveness of intermittent pneumatic compression (IPC) in treating patients with stroke. To establish whether or not the application of IPC to the legs of immobile stroke patients reduced their risk of deep vein thrombosis (DVT). Clots in Legs Or sTockings after Stroke (CLOTS) 3 was a multicentre, parallel-group, randomised controlled trial which allocated patients via a central randomisation system to IPC or no IPC. A technician blinded to treatment allocation performed compression duplex ultrasound (CDU) of both legs at 7-10 days and 25-30 days after enrolment. We followed up patients for 6 months to determine survival and later symptomatic VTE. Patients were analysed according to their treatment allocation. We enrolled 2876 patients in 94 UK hospitals between 8 December 2008 and 6 September 2012. patients admitted to hospital within 3 days of acute stroke and who were immobile on the day of admission (day 0) to day 3. age < 16 years; subarachnoid haemorrhage; and contra-indications to IPC including dermatitis, leg ulcers, severe oedema, severe peripheral vascular disease and congestive cardiac failure. Participants were allocated to routine care or routine care plus IPC for 30 days, or until earlier discharge or walking independently. The primary outcome was DVT in popliteal or femoral veins, detected on a screening CDU, or any symptomatic DVT in the proximal veins, confirmed by imaging, within 30 days of randomisation. The secondary outcomes included death, any DVTs, symptomatic DVTs, pulmonary emboli, skin breaks on the legs, falls with injury or fractures and duration of IPC use occurring within 30 days of randomisation and survival, symptomatic VTE, disability (as measured by the Oxford Handicap Scale), quality of life (as measured by the European Quality of Life-5 Dimensions 3 Level questionnaire) and length of initial hospital stay measured 6 months after randomisation. We allocated 1438 patients to IPC and 1438 to no IPC. The primary outcome occurred in 122 (8.5%) of 1438 patients allocated to IPC and 174 (12.1%) of 1438 patients allocated to no IPC, giving an absolute reduction in risk of 3.6% [95% confidence interval (CI) 1.4% to 5.8%] and a relative risk reduction of 0.69 (95% CI 0.55 to 0.86). After excluding 323 patients who died prior to any primary outcome and 41 who had no screening CDU, the primary outcome occurred in 122 of 1267 IPC participants compared with 174 of 1245 no-IPC participants, giving an adjusted odds ratio of 0.65 (95% CI 0.51 to 0.84; p = 0.001). Secondary outcomes in IPC compared with no-IPC participants were death in the treatment period in 156 (10.8%) versus 189 (13.1%) (p = 0.058); skin breaks in 44 (3.1%) versus 20 (1.4%) (p = 0.002); and falls with injury in 33 (2.3%) versus 24 (1.7%) (p = 0.221). Among patients treated with IPC, there was a statistically significant improvement in survival to 6 months (hazard ratio 0.86, 95% CI 0.73 to 0.99; p = 0.042), but no improvement in disability. The direct cost of preventing a DVT was £1282 per event (95% CI £785 to £3077). IPC is an effective and inexpensive method of reducing the risk of DVT and improving survival in immobile stroke patients. Further research should test whether or not IPC improves survival in other groups of high-risk hospitalised medical patients. In addition, research into methods to improve adherence to IPC might increase the benefits of IPC in stroke patients. Current Controlled Trials ISRCTN93529999. The start-up phase of the trial (December 2008-March 2010) was funded by the Chief Scientist Office of the Scottish Government (reference number CZH/4/417). The main phase of the trial was funded by the National Institute for Health Research Health Technology Assessment programme (reference number 08/14/03). Covidien Ltd (Mansfield, MA, USA) lent its Kendall SCD™ Express sequential compression system controllers to the 105 centres involved in the trial and donated supplies of its sleeves. It also provided logistical help in keeping our centres supplied with sleeves and training materials relevant to the use of their devices. Recruitment and follow-up were supported by the National Institute for Health Research-funded UK Stroke Research Network and by the Scottish Stroke Research Network, which was supported by NHS Research Scotland.

Lung Quality and Utilization in Controlled Donation after Circulatory Determination of Death Donors within the United States

PubMed Central

Mooney, Joshua J; Hedlin, Haley; Mohabir, Paul K; Vazquez, Rodrigo; Nguyen, John; Ha, Richard; Chiu, Peter; Patel, Kapilkumar; Zamora, Martin R.; Weill, David; Nicolls, Mark R; Dhillon, Gundeep S

2016-01-01

While controlled donation after circulatory determination of death (cDCDD) donors could increase the supply of donor lungs within the United States, the yield of lungs from cDCDD donors remain low compared to donation after neurologic determination of death (DNDD) donors. To explore the reason for low lung yield from cDCDD donors, Scientific Registry of Transplant Recipient data were used to assess the impact of donor lung quality on cDCDD lung utilization by fitting a logistic regression model. The relationship between center volume and cDCDD use was assessed and distance between center and donor hospital was calculated by cDCDD status. Recipient survival was compared using a multivariable Cox regression model. Lung utilization was 2.1% for cDCDD donors and 21.4% for DNDD donors. Being a cDCDD donor decreased lung donation (adjusted OR 0.101, CI 0.085–0.120). A minority of centers have performed cDCDD transplant with higher volume centers generally performing more cDCDD transplants. There was no difference in center to donor distance or recipient survival (adjusted HR 1.03, CI 0.78–1.37) between cDCDD and DNDD transplants. cDCDD lungs are underutilized compared to DNDD lungs after adjusting for lung quality. Increasing transplant center expertise and commitment to cDCDD lung procurement is needed to improve utilization. PMID:26844673

Effects of classroom education on knowledge and attitudes regarding organ donation in ethnically diverse urban high schools

PubMed Central

Cárdenas, Vicky; Thornton, John Daryl; Wong, Kristine A.; Spigner, Clarence; Allen, Margaret D.

2010-01-01

School-based health education is a promising approach for improving organ donation rates, but little is known about its efficacy among ethnically diverse youth. The impact of a classroom intervention was examined in a multicultural high school population where students’ ethnicities were 45% African American, 30% Asian American, and 33% Caucasian (allowing for multiracial choices). A baseline survey was administered to all health classes within 2 weeks prior to intervention. On the intervention day, classes randomly assigned to the intervention group received an educational session, followed by a second survey; in control classes, the second survey was taken before the educational session. At baseline, non-Caucasian ethnicity and male gender were each associated with lower levels of willingness to donate. Following the intervention, students in the intervention group demonstrated a significant increase in knowledge scores (p<0.001), as well as positive movement of opinion regarding willingness to donate (p<0.0001). Most importantly, the positive changes in opinion occurred independently of ethnicity and gender, in spite of these both being negative predictors of opinion at baseline. These results demonstrate that even a single classroom exposure can impact knowledge levels, correct misinformation, and effect opinion change on organ donation among an ethnically diverse adolescent population. PMID:20088915

Seroprevalence of Trypanosoma cruzi in blood donors at the National Blood Transfusion Services--Guyana.

PubMed

Bwititi, P T; Browne, J

2012-09-01

Blood transfusion is an important transmission route of Trypanosoma cruzi (T cruzi), a major parasitic infection in Central and South America. The limited treatment options are most effective in acute Chagas' infection. At present, there is no current data on the prevalence of T cruzi in the blood donor population of Guyana. This information is necessary to protect the supply of the blood donation programme. This study sought to determine the prevalence of T cruzi in the blood supply at the National Blood Transfusion Services of Guyana with the hope of providing knowledge to the on-going surveillance for Chagas' disease worldwide and therefore address the risk of its spread by blood transfusion. Two commercialized ELISAs utilizing crude or recombinant T cruzi antigens were used to study 2000 blood samples voluntarily donated for the purpose of altruistic or family replacement donation retrospectively. The results showed that approximately 1 in 286 donations tested positive for antibodies to T cruzi. These results indicate that T cruzi continues to be a risk in Guyana and there is a need to continue screening donated blood. Trypanosoma cruzi is a life-long infection and infected persons may be asymptomatic chronic carriers of the disease. Education, housing improvement, and controlled use of insecticides should be introduced to contain Chagas' disease.

Clarifying the paradigm for the ethics of donation and transplantation: Was 'dead' really so clear before organ donation?

PubMed Central

Shemie, Sam D

2007-01-01

Recent commentaries by Verheijde et al, Evans and Potts suggesting that donation after cardiac death practices routinely violate the dead donor rule are based on flawed presumptions. Cell biology, cardiopulmonary resuscitation, critical care life support technologies, donation and transplantation continue to inform concepts of life and death. The impact of oxygen deprivation to cells, organs and the brain is discussed in relation to death as a biological transition. In the face of advancing organ support and replacement technologies, the reversibility of cardiac arrest is now purely related to the context in which it occurs, in association to the availability and application of support systems to maintain oxygenated circulation. The 'complete and irreversible' lexicon commonly used in death discussions and legal statutes are ambiguous, indefinable and should be replaced by accurate terms. Criticism of controlled DCD on the basis of violating the dead donor rule, where autoresuscitation has not been described beyond 2 minutes, in which life support is withdrawn and CPR is not provided, is not valid. However, any post mortem intervention that re-establishes brain blood flow should be prohibited. In comparison to traditional practice, organ donation has forced the clarification of the diagnostic criteria for death and improved the rigour of the determinations. PMID:17718918

Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial.

PubMed

Rahn, Anne C; Backhus, Imke; Fuest, Franz; Riemann-Lorenz, Karin; Köpke, Sascha; van de Roemer, Adrianus; Mühlhauser, Ingrid; Heesen, Christoph

2016-09-20

Presentation of confidence intervals alongside information about treatment effects can support informed treatment choices in people with multiple sclerosis. We aimed to develop and pilot-test different written patient information materials explaining confidence intervals in people with relapsing-remitting multiple sclerosis. Further, a questionnaire on comprehension of confidence intervals was developed and piloted. We developed different patient information versions aiming to explain confidence intervals. We used an illustrative example to test three different approaches: (1) short version, (2) "average weight" version and (3) "worm prophylaxis" version. Interviews were conducted using think-aloud and teach-back approaches to test feasibility and analysed using qualitative content analysis. To assess comprehension of confidence intervals, a six-item multiple choice questionnaire was developed and tested in a pilot randomised controlled trial using the online survey software UNIPARK. Here, the average weight version (intervention group) was tested against a standard patient information version on confidence intervals (control group). People with multiple sclerosis were invited to take part using existing mailing-lists of people with multiple sclerosis in Germany and were randomised using the UNIPARK algorithm. Participants were blinded towards group allocation. Primary endpoint was comprehension of confidence intervals, assessed with the six-item multiple choice questionnaire with six points representing perfect knowledge. Feasibility of the patient information versions was tested with 16 people with multiple sclerosis. For the pilot randomised controlled trial, 64 people with multiple sclerosis were randomised (intervention group: n = 36; control group: n = 28). More questions were answered correctly in the intervention group compared to the control group (mean 4.8 vs 3.8, mean difference 1.1 (95 % CI 0.42-1.69), p = 0.002). The questionnaire's internal consistency was moderate (Cronbach's alpha = 0.56). The pilot-phase shows promising results concerning acceptability and feasibility. Pilot randomised controlled trial results indicate that the patient information is well understood and that knowledge gain on confidence intervals can be assessed with a set of six questions. German Clinical Trials Register: DRKS00008561 . Registered 8th of June 2015.

Waste the waist: a pilot randomised controlled trial of a primary care based intervention to support lifestyle change in people with high cardiovascular risk.

PubMed

Greaves, Colin; Gillison, Fiona; Stathi, Afroditi; Bennett, Paul; Reddy, Prasuna; Dunbar, James; Perry, Rachel; Messom, Daniel; Chandler, Roger; Francis, Margaret; Davis, Mark; Green, Colin; Evans, Philip; Taylor, Gordon

2015-01-16

In the UK, thousands of people with high cardiovascular risk are being identified by a national risk-assessment programme (NHS Health Checks). Waste the Waist is an evidence-informed, theory-driven (modified Health Action Process Approach), group-based intervention designed to promote healthy eating and physical activity for people with high cardiovascular risk. This pilot randomised controlled trial aimed to assess the feasibility of delivering the Waste the Waist intervention in UK primary care and of conducting a full-scale randomised controlled trial. We also conducted exploratory analyses of changes in weight. Patients aged 40-74 with a Body Mass Index of 28 or more and high cardiovascular risk were identified from risk-assessment data or from practice database searches. Participants were randomised, using an online computerised randomisation algorithm, to receive usual care and standardised information on cardiovascular risk and lifestyle (Controls) or nine sessions of the Waste the Waist programme (Intervention). Group allocation was concealed until the point of randomisation. Thereafter, the statistician, but not participants or data collectors were blinded to group allocation. Weight, physical activity (accelerometry) and cardiovascular risk markers (blood tests) were measured at 0, 4 and 12 months. 108 participants (22% of those approached) were recruited (55 intervention, 53 controls) from 6 practices and 89% provided data at both 4 and 12 months. Participants had a mean age of 65 and 70% were male. Intervention participants attended 72% of group sessions. Based on last observations carried forward, the intervention group did not lose significantly more weight than controls at 12 months, although the difference was significant when co-interventions and co-morbidities that could affect weight were taken into account (Mean Diff 2.6Kg. 95%CI: -4.8 to -0.3, p = 0.025). No significant differences were found in physical activity. The Waste the Waist intervention is deliverable in UK primary care, has acceptable recruitment and retention rates and produces promising preliminary weight loss results. Subject to refinement of the physical activity component, it is now ready for evaluation in a full-scale trial. Current Controlled Trials ISRCTN10707899 .

A feasibility randomised controlled trial of pre-operative occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis (PROOF-THR).

PubMed

Jepson, Paul; Sands, Gina; Beswick, Andrew D; Davis, Edward T; Blom, Ashley W; Sackley, Catherine M

2016-02-01

To assess the feasibility of a pre-operative occupational therapy intervention for patients undergoing primary total hip replacement. Single blinded feasibility randomised controlled trial, with data collection prior to the intervention, and at 4, 12, and 26 weeks following surgery. Recruitment from two NHS orthopaedic outpatient centres in the West Midlands, UK. Patients awaiting primary total hip replacement due to osteoarthritis were recruited. Following pre-operative assessment, patients were individually randomised to intervention or control by a computer-generated block randomisation algorithm stratified by age and centre. The intervention group received a pre-surgery home visit by an occupational therapist who discussed expectations, assessed home safety, and provided appropriate adaptive equipment. The control group received treatment as usual. The study assessed the feasibility of recruitment procedures, delivery of the intervention, appropriateness of outcome measures and data collection methods. Health related quality of life and resource use were recorded at 4, 12 and 26 weeks. Forty-four participants were recruited, 21 were randomised to the occupational therapy intervention and 23 to usual care. Analysis of 26 week data included 18 participants in the intervention group and 21 in the control. The intervention was delivered successfully with no withdrawals or crossovers; 5/44 were lost to follow-up with further missing data for participation and resource use. The feasibility study provided the information required to conduct a definitive trial. Burden of assessment would need to be addressed. A total of 219 patients would be required in an efficacy trial. © The Author(s) 2015.

Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial.

PubMed

Hopewell, Sally; Boutron, Isabelle; Altman, Douglas G; Barbour, Ginny; Moher, David; Montori, Victor; Schriger, David; Cook, Jonathan; Gerry, Stephen; Omar, Omar; Dutton, Peter; Roberts, Corran; Frangou, Eleni; Clifton, Lei; Chiocchia, Virginia; Rombach, Ines; Wartolowska, Karolina; Ravaud, Philippe

2016-11-28

The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications. We conducted a parallel group randomised trial. Journals which endorsed the CONSORT Statement (i.e. referred to it in the Instruction to Authors) but do not actively implement it (i.e. require authors to submit a completed CONSORT checklist) were invited to participate. Authors of randomised trials were requested by the editor to use the web-based tool at the manuscript revision stage. Authors registering to use the tool were randomised (centralised computer generated) to WebCONSORT or control. In the WebCONSORT group, they had access to a tool allowing them to combine the different CONSORT extensions relevant to their trial and generate a customised checklist and flow diagram that they must submit to the editor. In the control group, authors had only access to a CONSORT flow diagram generator. Authors, journal editors, and outcome assessors were blinded to the allocation. The primary outcome was the proportion of CONSORT items (main and extensions) reported in each article post revision. A total of 46 journals actively recruited authors into the trial (25 March 2013 to 22 September 2015); 324 author manuscripts were randomised (WebCONSORT n = 166; control n = 158), of which 197 were reports of randomised trials (n = 94; n = 103). Over a third (39%; n = 127) of registered manuscripts were excluded from the analysis, mainly because the reported study was not a randomised trial. Of those included in the analysis, the most common CONSORT extensions selected were non-pharmacologic (n = 43; n = 50), pragmatic (n = 20; n = 16) and cluster (n = 10; n = 9). In a quarter of manuscripts, authors either wrongly selected an extension or failed to select the right extension when registering their manuscript on the WebCONSORT study site. Overall, there was no important difference in the overall mean score between WebCONSORT (mean score 0.51) and control (0.47) in the proportion of CONSORT and CONSORT extension items reported pertaining to a given study (mean difference, 0.04; 95% CI -0.02 to 0.10). This study failed to show a beneficial effect of a customised web-based CONSORT checklist to help authors prepare more complete trial reports. However, the exclusion of a large number of inappropriately registered manuscripts meant we had less precision than anticipated to detect a difference. Better education is needed, earlier in the publication process, for both authors and journal editorial staff on when and how to implement CONSORT and, in particular, CONSORT-related extensions. ClinicalTrials.gov: NCT01891448 [registered 24 May 2013].

Developing an Australian-first recovery model for parents in Victorian mental health and family services: a study protocol for a randomised controlled trial.

PubMed

Maybery, Darryl; Goodyear, Melinda; Reupert, Andrea; Sheen, Jade; Cann, Warren; Dalziel, Kim; Tchernagovski, Phillip; O'Hanlon, Brendan; von Doussa, Henry

2017-05-26

A considerable number of people with a mental illness are parents caring for dependent children. For those with a mental illness, parenting can provide a sense of competence, belonging, identity and hope and hence is well aligned to the concept of personal recovery. However, little research has focused on the recovery journey of those who are parents and have a mental illness. This randomised controlled trial aims to (i) evaluate the effectiveness of an intervention model of recovery for parents (Let's Talk about Children) in three different mental health service sectors and (ii) examine the economic value of a larger roll out (longer term) of the parent recovery model. A two arm parallel randomised controlled trial will be used with participants, who are being treated for their mental illness in adult mental health, non-government community mental health or family welfare services. The study will involve 192 parents, who are considered by their treating practitioner to be sufficiently well to provide informed consent and participate in an intervention (Let's Talk about Children) or control group (treatment as usual). Participant randomisation will occur at the level of the treating practitioner and will be based on whether the randomised practitioner is trained in the intervention. Outcomes are compared at pre, post intervention and six-month follow-up. Recovery, parenting and family functioning, and quality of life questionnaires will be used to measure parent wellbeing and the economic benefits of the intervention. This is the first randomised controlled trial to investigate the efficacy of a parenting intervention on recovery outcomes and the first to provide an economic evaluation of an intervention for parents with a mental illness. An implementation model is required to embed the intervention in different sectors. The trial was retrospectively registered: ACTRN12616000460404 on the 8/4/2016.

CONSORT item reporting quality in the top ten ranked journals of critical care medicine in 2011: a retrospective analysis.

PubMed

Stevanovic, Ana; Schmitz, Sabine; Rossaint, Rolf; Schürholz, Tobias; Coburn, Mark

2015-01-01

Reporting randomised controlled trials is a key element in order to disseminate research findings. The CONSORT statement was introduced to improve the reporting quality. We assessed the adherence to the CONSORT statement of randomised controlled trials published 2011 in the top ten ranked journals of critical care medicine (ISI Web of Knowledge 2011, Thomson Reuters, London UK). Design. We performed a retrospective cross sectional data analysis. Setting. This study was executed at the University Hospital of RWTH, Aachen. Participants. We selected the following top ten listed journals according to ISI Web of Knowledge (Thomson Reuters, London, UK) critical care medicine ranking in the year 2011: American Journal of Respiratory and Critical Care Medicine, Critical Care Medicine, Intensive Care Medicine, CHEST, Critical Care, Journal of Neurotrauma, Resuscitation, Pediatric Critical Care Medicine, Shock and Minerva Anestesiologica. Main outcome measures. We screened the online table of contents of each included journal, to identify the randomised controlled trials. The adherence to the items of the CONSORT Checklist in each trial was evaluated. Additionally we correlated the citation frequency of the articles and the impact factor of the respective journal with the amount of reported items per trial. We analysed 119 randomised controlled trials and found, 15 years after the implementation of the CONSORT statement, that a median of 61,1% of the checklist-items were reported. Only 55.5% of the articles were identified as randomised trials in their titles. The citation frequency of the trials correlated significantly (rs = 0,433; p<0,001 and r = 0,331; p<0,001) to the CONSORT statement adherence. The impact factor showed also a significant correlation to the CONSORT adherence (r = 0,386; p<0,001). The reporting quality of randomised controlled trials in the field of critical care medicine remains poor and needs considerable improvement.

The Efficacy of Phonics-Based Instruction of English as a Second Language in an Italian High School: A Randomised Controlled Trial

ERIC Educational Resources Information Center

Coates, Robert Alexander Graham; Gorham, Judith; Nicholas, Richard

2017-01-01

Recent neurological breakthroughs in our understanding of the Critical Period Hypothesis and prosody may suggest strategies on how phonics instruction could improve L2 language learning and in particular phoneme/grapheme decoding. We therefore conducted a randomised controlled-trial on the application of prosody and phonics techniques, to improve…

Information and Choice of A-Level Subjects: A Cluster Randomised Controlled Trial with Linked Administrative Data

ERIC Educational Resources Information Center

Davies, Peter; Davies, Neil M.; Qiu, Tian

2017-01-01

We estimated the effects of an intervention which provided information about graduate wages to 5593 students in England, using a blinded cluster randomised controlled trial in 50 schools (registration: AEARCTR-0000468). Our primary outcome was students' choice of A-level subjects at age 16. We also recorded the students' expectations of future…

A New Social Communication Intervention for Children with Autism: Pilot Randomised Controlled Treatment Study Suggesting Effectiveness

ERIC Educational Resources Information Center

Aldred, Catherine; Green, Jonathan; Adams, Catherine

2004-01-01

Background: Psychosocial treatments are the mainstay of management of autism in the UK but there is a notable lack of a systematic evidence base for their effectiveness. Randomised controlled trial (RCT) studies in this area have been rare but are essential because of the developmental heterogeneity of the disorder. We aimed to test a new…

A Randomised Group Comparison Controlled Trial of "Preschoolers with Autism": A Parent Education and Skills Training Intervention for Young Children with Autistic Disorder

ERIC Educational Resources Information Center

Tonge, Bruce; Brereton, Avril; Kiomall, Melissa; Mackinnon, Andrew; Rinehart, Nicole J.

2014-01-01

Aim: To determine the effect of parent education on adaptive behaviour, autism symptoms and cognitive/language skills of young children with autistic disorder. Method: A randomised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent…

Randomised Controlled Trial of a Parenting Intervention in the Voluntary Sector for Reducing Child Conduct Problems: Outcomes and Mechanisms of Change

ERIC Educational Resources Information Center

Gardner, Frances; Burton, Jennifer; Klimes, Ivana

2006-01-01

Background: To test effectiveness of a parenting intervention, delivered in a community-based voluntary-sector organisation, for reducing conduct problems in clinically-referred children. Methods: Randomised controlled trial, follow-up at 6, 18 months, assessors blind to treatment status. Participants--76 children referred for conduct problems,…

Are Prenatal Ultrasound Scans Associated with the Autism Phenotype? Follow-Up of a Randomised Controlled Trial

ERIC Educational Resources Information Center

Stoch, Yonit K.; Williams, Cori J.; Granich, Joanna; Hunt, Anna M.; Landau, Lou I.; Newnham, John P.; Whitehouse, Andrew J. O.

2012-01-01

An existing randomised controlled trial was used to investigate whether multiple ultrasound scans may be associated with the autism phenotype. From 2,834 single pregnancies, 1,415 were selected at random to receive ultrasound imaging and continuous wave Doppler flow studies at five points throughout pregnancy (Intensive) and 1,419 to receive a…

An analysis of first-time blood donors return behaviour using regression models.

PubMed

Kheiri, S; Alibeigi, Z

2015-08-01

Blood products have a vital role in saving many patients' lives. The aim of this study was to analyse blood donor return behaviour. Using a cross-sectional follow-up design of 5-year duration, 864 first-time donors who had donated blood were selected using a systematic sampling. The behaviours of donors via three response variables, return to donation, frequency of return to donation and the time interval between donations, were analysed based on logistic regression, negative binomial regression and Cox's shared frailty model for recurrent events respectively. Successful return to donation rated at 49·1% and the deferral rate was 13·3%. There was a significant reverse relationship between the frequency of return to donation and the time interval between donations. Sex, body weight and job had an effect on return to donation; weight and frequency of donation during the first year had a direct effect on the total frequency of donations. Age, weight and job had a significant effect on the time intervals between donations. Aging decreases the chances of return to donation and increases the time interval between donations. Body weight affects the three response variables, i.e. the higher the weight, the more the chances of return to donation and the shorter the time interval between donations. There is a positive correlation between the frequency of donations in the first year and the total number of return to donations. Also, the shorter the time interval between donations is, the higher the frequency of donations. © 2015 British Blood Transfusion Society.

Concordance and acceptability of electric stimulation therapy: a randomised controlled trial.

PubMed

Miller, C; McGuiness, W; Wilson, S; Cooper, K; Swanson, T; Rooney, D; Piller, N; Woodward, M

2017-08-02

A pilot single-blinded randomised controlled trial (RCT) was conducted to examine concordance with and acceptability of electric stimulation therapy (EST) in patients with venous leg ulcers (VLUs) who had not tolerated moderate to high compression. Participants were randomised to the intervention group (n=15) or a placebo control group (n=8) in which EST was used four times daily for 20 minutes per session. Participants were monitored for eight weeks during which time concordance with the treatment and perceptions of the treatment were assessed. Concordance with the total recommended treatment time was 71.4% for the intervention group and 82.9% for the control group; a difference that was not statistically significant. Participants rated EST as acceptable (84.6% intervention; 83.3% control), only two participants, both from the placebo control group, would not be willing to use EST again. The majority considered EST easier to use than compression (68.4%). EST was a practical and acceptable treatment among people who have been unable to tolerate moderate to high compression therapy.

Give blood today or save lives tomorrow: Matching decision and message construal level to maximize blood donation intentions.

PubMed

Czeizler, Amalia; Garbarino, Ellen

2017-01-01

The research extends construal theory by testing if a match between the temporal construal framing of a blood donation decision and a blood donation request leads to higher donation intentions than a mismatch. Results show participants considering future donation who read an abstract donation request have significantly higher donation intentions than those who read a concrete request. Conversely, participants considering donating today who read a concrete donation request have significantly higher donation intentions than those who read an abstract request. This study confirms the importance of matching the construal framing of the communication to the temporal framing of the decision.

Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers

PubMed Central

2011-01-01

Background Smoking prevalence is high among Pakistani and Bangladeshi men in the UK, but there are few tailored smoking cessation programmes for Pakistani and Bangladeshi communities. The aim of this study was to pilot a cluster randomised controlled trial comparing the effectiveness of Pakistani and Bangladeshi smoking cessation outreach workers with standard care to improve access to and the success of English smoking cessation services. Methods A pilot cluster randomised controlled trial was conducted in Birmingham, UK. Geographical lower layer super output areas were used to identify natural communities where more than 10% of the population were of Pakistani and Bangladeshi origin. 16 agglomerations of super output areas were randomised to normal care controls vs. outreach intervention. The number of people setting quit dates using NHS services, validated abstinence from smoking at four weeks, and stated abstinence at three and six months were assessed. The impact of the intervention on choice and adherence to treatments, attendance at clinic appointments and patient satisfaction were also assessed. Results We were able to randomise geographical areas and deliver the outreach worker-based services. More Pakistani and Bangladeshi men made quit attempts with NHS services in intervention areas compared with control areas, rate ratio (RR) 1.32 (95%CI: 1.03-1.69). There was a small increase in the number of 4-week abstinent smokers in intervention areas (RR 1.30, 95%CI: 0.82-2.06). The proportion of service users attending weekly appointments was lower in intervention areas than control areas. No difference was found between intervention and control areas in choice and adherence to treatments or patient satisfaction with the service. The total cost of the intervention was £124,000; an estimated cost per quality-adjusted life year (QALY) gained of £8,500. Conclusions The intervention proved feasible and acceptable. Outreach workers expanded reach of smoking cessation services in diverse locations of relevance to Pakistani and Bangladeshi communities. The outreach worker model has the potential to increase community cessation rates and could prove cost-effective, but needs evaluating definitively in a larger, appropriately powered, randomised controlled trial. These future trials of outreach interventions need to be of sufficient duration to allow embedding of new models of service delivery. Trial registration Current Controlled Trials ISRCTN82127540 PMID:21854596

Exercise and mental health: a review.

PubMed

Glenister, D

1996-02-01

With the advent of programmes to raise the level of fitness in the general population, and alliances between primary health care and community leisure services, the potential of exercise in promoting mental as well as physical health deserves investigation. In contrast to USA and continental Europe, there is a paucity of British research studies systematically exploring the mental health benefits of exercise. The recent rapid growth of exercise prescription among general practitioners presents an opportunity for future research. This review of eleven randomised control trials (RCTs) suggests a causal relationship between exercise and mental health based upon studies in various settings. The methodological difficulties associated with randomised control trials of psycho-social interventions are discussed. The value of future randomised control trials which incorporate examination of perceived acceptability and health economics is indicated.

Effect of media presentations on willingness to commit to organ donation.

PubMed

Harel, Inbal; Kogut, Tehila; Pinchas, Meir; Slovic, Paul

2017-05-16

We examine how presentations of organ donation cases in the media may affect people's willingness to sign organ donation commitment cards, donate the organs of a deceased relative, support the transition to an "opt-out" policy, or donate a kidney while alive. We found that providing identifying information about the prospective recipient (whose life was saved by the donation) increased the participants' willingness to commit to organ donation themselves, donate the organs of a deceased relative, or support a transition to an "opt-out" policy. Conversely, identifying the deceased donor tended to induce thoughts of death rather than about saving lives, resulting in fewer participants willing to donate organs or support measures that facilitated organ donation. A study of online news revealed that identification of the donor is significantly more common than identification of the recipient in the coverage of organ donation cases-with possibly adverse effects on the incidence of organ donations.

An investigation of the impact of Melbourne Zoo's "Seal-the-Loop" donate call-to-action on visitor satisfaction and behavior.

PubMed

Mellish, Sarah; Sanders, Ben; Litchfield, Carla A; Pearson, Elissa L

2017-05-01

Modern zoos are uniquely positioned to educate the public about environmental issues and promote conservation action. This report investigates the introduction of a donation request during an interactive fur seal presentation (as part of Melbourne Zoo's "Seal-the-Loop" initiative) on visitor satisfaction, perceptions of donation as a way to help wild fur seals, and donation behaviors. Comparisons are made between three groups surveyed upon exit: (1) viewed the interactive fur seal presentation prior to the donation request implementation (pledge-presentation: N = 86; see Mellish, Pearson, Sanders, and Litchfield []; International Zoo Yearbook 129:129-154); (2) viewed the interactive fur seal presentation including the donation request (donate-presentation: N = 82); and (3) viewed the fur seal exhibit and donation point but not the presentation and were not directly asked to make a donation (donate-exhibit: N = 82). Findings demonstrate visitor satisfaction with the interactive fur seal presentation was not negatively impacted following the implementation of the donate request (with >92% of pledge-presentation and donate-presentation visitors providing a "satisfied" or "very satisfied" rating). Only the donate-presentation visitors reported donation as a conservation action to help wild fur seals (19.18%; 0% for pledge-presentation visitors). While both donate-exhibit (39.51%) and donate-presentation visitors (60.75%) self-reported making donations or intending to do so, donation behavior was significantly increased for visitors who had viewed the fur seal presentation. Findings provide preliminary support that zoos may utilize interactive educational presentations to effectively ask visitors for donations to support specific conservation projects, without negatively impacting on satisfaction and with a relatively high level of visitor engagement. © 2017 Wiley Periodicals, Inc.

Foot orthoses in the treatment of symptomatic midfoot osteoarthritis using clinical and biomechanical outcomes: a randomised feasibility study.

PubMed

Halstead, Jill; Chapman, Graham J; Gray, Janine C; Grainger, Andrew J; Brown, Sarah; Wilkins, Richard A; Roddy, Edward; Helliwell, Philip S; Keenan, Anne-Maree; Redmond, Anthony C

2016-04-01

This randomised feasibility study aimed to examine the clinical and biomechanical effects of functional foot orthoses (FFOs) in the treatment of midfoot osteoarthritis (OA) and the feasibility of conducting a full randomised controlled trial. Participants with painful, radiographically confirmed midfoot OA were recruited and randomised to receive either FFOs or a sham control orthosis. Feasibility measures included recruitment and attrition rates, practicality of blinding and adherence rates. Clinical outcome measures were: change from baseline to 12 weeks for severity of pain (numerical rating scale), foot function (Manchester Foot Pain and Disability Index) and patient global impression of change scale. To investigate the biomechanical effect of foot orthoses, in-shoe foot kinematics and plantar pressures were evaluated at 12 weeks. Of the 119 participants screened, 37 were randomised and 33 completed the study (FFO = 18, sham = 15). Compliance with foot orthoses and blinding of the intervention was achieved in three quarters of the group. Both groups reported improvements in pain, function and global impression of change; the FFO group reporting greater improvements compared to the sham group. The biomechanical outcomes indicated the FFO group inverted the hindfoot and increased midfoot maximum plantar force compared to the sham group. The present findings suggest FFOs worn over 12 weeks may provide detectable clinical and biomechanical benefits compared to sham orthoses. This feasibility study provides useful clinical, biomechanical and statistical information for the design and implementation of a definitive randomised controlled trial to evaluate the effectiveness of FFOs in treating painful midfoot OA.

The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola.

PubMed

2015-07-27

A World Health Organization expert meeting on Ebola vaccines proposed urgent safety and efficacy studies in response to the outbreak in West Africa. One approach to communicable disease control is ring vaccination of individuals at high risk of infection due to their social or geographical connection to a known case. This paper describes the protocol for a novel cluster randomised controlled trial design which uses ring vaccination.In the Ebola ça suffit ring vaccination trial, rings are randomised 1:1 to (a) immediate vaccination of eligible adults with single dose vaccination or (b) vaccination delayed by 21 days. Vaccine efficacy against disease is assessed in participants over equivalent periods from the day of randomisation. Secondary objectives include vaccine effectiveness at the level of the ring, and incidence of serious adverse events. Ring vaccination trials are adaptive, can be run until disease elimination, allow interim analysis, and can go dormant during inter-epidemic periods. © Ebola ça suffit ring vaccination trial consortium 2015.

Placebo effects in psychiatry: mediators and moderators

PubMed Central

Weimer, Katja; Colloca, Luana; Enck, Paul

2015-01-01

A strong placebo response in psychiatric disorders has been noted for the past 50 years and various attempts have been made to identify predictors of it, by use of meta-analyses of randomised controlled trials and laboratory studies. We reviewed 31 meta-analyses and systematic reviews of more than 500 randomised placebo-controlled trials across psychiatry (depression, schizophrenia, mania, attention-deficit hyperactivity disorder, autism, psychosis, binge-eating disorder, and addiction) for factors identified to be associated with increased placebo response. Of 20 factors discussed, only three were often linked to high placebo responses: low baseline severity of symptoms, more recent trials, and unbalanced randomisation (more patients randomly assigned to drug than placebo). Randomised controlled trials in non-drug therapy have not added further predictors, and laboratory studies with psychological, brain, and genetic approaches have not been successful in identifying predictors of placebo responses. This comprehensive Review suggests that predictors of the placebo response are still to be discovered, the response probably has more than one mediator, and that different and distinct moderators are probably what cause the placebo response within psychiatry and beyond. PMID:25815249

Screening versus routine practice in detection of atrial fibrillation in patients aged 65 or over: cluster randomised controlled trial

PubMed Central

Fitzmaurice, David A; Jowett, Sue; Mant, Jonathon; Murray, Ellen T; Holder, Roger; Raftery, J P; Bryan, S; Davies, Michael; Lip, Gregory Y H; Allan, T F

2007-01-01

Objectives To assess whether screening improves the detection of atrial fibrillation (cluster randomisation) and to compare systematic and opportunistic screening. Design Multicentred cluster randomised controlled trial, with subsidiary trial embedded within the intervention arm. Setting 50 primary care centres in England, with further individual randomisation of patients in the intervention practices. Participants 14 802 patients aged 65 or over in 25 intervention and 25 control practices. Interventions Patients in intervention practices were randomly allocated to systematic screening (invitation for electrocardiography) or opportunistic screening (pulse taking and invitation for electrocardiography if the pulse was irregular). Screening took place over 12 months in each practice from October 2001 to February 2003. No active screening took place in control practices. Main outcome measure Newly identified atrial fibrillation. Results The detection rate of new cases of atrial fibrillation was 1.63% a year in the intervention practices and 1.04% in control practices (difference 0.59%, 95% confidence interval 0.20% to 0.98%). Systematic and opportunistic screening detected similar numbers of new cases (1.62% v 1.64%, difference 0.02%, −0.5% to 0.5%). Conclusion Active screening for atrial fibrillation detects additional cases over current practice. The preferred method of screening in patients aged 65 or over in primary care is opportunistic pulse taking with follow-up electrocardiography. Trial registration Current Controlled Trials ISRCTN19633732. PMID:17673732

Guided, internet-based, rumination-focused cognitive behavioural therapy (i-RFCBT) versus a no-intervention control to prevent depression in high-ruminating young adults, along with an adjunct assessment of the feasibility of unguided i-RFCBT, in the REducing Stress and Preventing Depression trial (RESPOND): study protocol for a phase III randomised controlled trial.

PubMed

Cook, Lorna; Watkins, Edward

2016-01-04

Depression is a global health challenge. Prevention is highlighted as a priority to reduce its prevalence. Although effective preventive interventions exist, the efficacy and coverage can be improved. One proposed means to increase efficacy is by using interventions to target specific risk factors, such as rumination. Rumination-focused CBT (RFCBT) was developed to specifically target depressive rumination and reduces acute depressive symptoms and relapse for patients with residual depression in a randomised controlled trial. Preliminary findings from a Dutch randomised prevention trial in 251 high-risk 15- to 22-year-old subjects selected with elevated worry and rumination found that both supported internet-RFBCT and group-delivered RFCBT equally reduced depressive symptoms and the onset of depressive cases over a period of 1 year, relative to the no-intervention control. A phase III randomised controlled trial following the Medical Research Council (MRC) Complex Interventions Framework will extend a Dutch trial to the United Kingdom, with the addition of diagnostic interviews, primarily to test whether guided internet-RFCBT reduces the onset of depression relative to a no-intervention control. High-risk young adults (aged 18 to 24 years), selected with elevated worry/rumination and recruited through university and internet advertisement, will be randomised to receive either guided internet-RFCBT, supported by clinical psychologists or mental health paraprofessionals, or a no-intervention control. As an adjunct arm, participants are also randomised to unguided internet-RFCBT self-help to provide an initial test of the feasibility and effect size of this intervention. While participants are also randomised to unguided internet-RFCBT, the trial was designed and powered as a phase III trial comparing guided internet-RFCBT versus a no-intervention control. In the comparison between these two arms, the primary outcomes are as follows: a) onset of major depressive episode over a 12-month period, assessed with a Structured Clinical Interview for Diagnosis at 3 months (post-intervention), 6 months and 15 months after randomisation. The following secondary outcomes will be recorded: the incidence of generalized anxiety disorder, symptoms of depression and anxiety, and levels of worry and rumination, measured at baseline and at the same follow-up intervals. In relation to the pilot investigation of unguided internet-RFCBT (the adjunct intervention arm), we will assess the feasibility and acceptability of the data-collection procedures, levels of attrition, effect size and acceptability of the unguided internet-RFCBT intervention. Widespread implementation is necessary for effective prevention, suggesting that the internet may be a valuable mode of delivery. Previous research suggests that guided internet-RFCBT reduces incidence rates relative to controls. We are also interested in developing and evaluating an unguided version to potentially increase the availability and reduce the costs. Current Controlled Trials ISRCTN12683436 . Date of registration: 27 October 2014.

Does hospital at home for palliative care facilitate death at home? Randomised controlled trial

PubMed Central

Grande, Gunn E; Todd, Chris J; Barclay, Stephen I G; Farquhar, Morag C

1999-01-01

Objective To evaluate the impact on place of death of a hospital at home service for palliative care. Design Pragmatic randomised controlled trial. Setting Former Cambridge health district. Participants 229 patients referred to the hospital at home service; 43 randomised to control group (standard care), 186 randomised to hospital at home. Intervention Hospital at home versus standard care. Main outcome measures Place of death. Results Twenty five (58%) control patients died at home compared with 124 (67%) patients allocated to hospital at home. This difference was not significant; intention to treat analysis did not show that hospital at home increased the number of deaths at home. Seventy three patients randomised to hospital at home were not admitted to the service. Patients admitted to hospital at home were significantly more likely to die at home (88/113; 78%) than control patients. It is not possible to determine whether this was due to hospital at home itself or other characteristics of the patients admitted to the service. The study attained less statistical power than initially planned. Conclusion In a locality with good provision of standard community care we could not show that hospital at home allowed more patients to die at home, although neither does the study refute this. Problems relating to recruitment, attrition, and the vulnerability of the patient group make randomised controlled trials in palliative care difficult. While these difficulties have to be recognised they are not insurmountable with the appropriate resourcing and setting. Key messagesTerminally ill patients allocated to hospital at home were no more likely to die at home than patients receiving standard careAlthough the subsample of patients actually admitted to hospital at home did show a significant increase in likelihood of dying at home, whether this was due to the service itself or the characteristics of patients admitted to hospital at home could not be determinedThe need to balance ideal research design against the realities of evaluation of palliative care had the effect that the trial achieved less statistical power than originally plannedParticular problems were that many patients failed to receive the allocated intervention because of the unpredictable nature of terminal illness, inclusion of other service input alongside hospital at home, and the wide range of standard care availableThe trial illustrated problems associated with randomised controlled trials in palliative care, none of which are insurmountable but which require careful consideration and resourcing before future trials are planned PMID:10582932

Communication as a predictor of willingness to donate one's organs: an addition to the Theory of Reasoned Action.

PubMed

Jeffres, Leo W; Carroll, Jeanine A; Rubenking, Bridget E; Amschlinger, Joe

2008-12-01

Fishbein and Ajzen's theory of reasoned action has been used by many researchers, particularly in regard to health communication, to predict behavioral intentions and behavior. According to that theory, one's intention is the best predictor that one will engage in a behavior, and attitudes and social norms predict behavioral intentions. Other researchers have added different variables to the postulates of attitudes and social norms that Fishbein and Ajzen maintain are the best predictors of behavioral intention. Here we draw on data from a 2006 telephone survey (N = 420) gauging the awareness of an organ donation campaign in Northeast Ohio to examine the impact of communication on people's intentions. The current study supports the hypothesis that those who communicate with others are more likely to express a greater willingness to become an organ donor, but it expands the range of communication contexts. With demographics and attitudes toward organ donation controlled for, this study shows that communication with others about organ donation increases the willingness of individuals to have favorable attitudes about being an organ donor.

Attitudes toward transplantation in U.K. Muslim Indo-Asians in west London.

PubMed

Alkhawari, Fawzi S; Stimson, Gerry V; Warrens, Anthony N

2005-06-01

The worldwide shortage of organs for transplantation makes it important to understand why some oppose donation. Attitudes vary with religion and ethnicity. Accordingly, we undertook a qualitative study of the attitudes of 141 U.K. Muslim Indo-Asians to organ donation. Participants were observed, focus group discussions held and in-depth individual interviews conducted. We identified a high level of alienation from the health care system in general. With respect to organ donation in particular, its importance was generally discounted, often in deference to authority figures within the community who appeared negatively disposed. The culture-specific issues arguing against donation included a sense of the sacredness of the body, a fatalistic approach to illness, a belief that organs took on an independent role as 'witnesses' to an individual's life on Judgement Day and an anxiety that the donor would have no control of the probity of the recipient of an organ. We believe these data suggest a need to improve in a culturally sensitive fashion the provision of health information provided to this community.

Improvement in likelihood to donate blood after being offered a topical anesthetic.

PubMed

Watanabe, Kyle M; Jay, Jeffrey; Alicto, Christopher; Yamamoto, Loren G

2011-02-01

While there are many reasons people choose not to donate blood, pain sustained during the venipuncture portion of the blood donation process is likely one deterrent to volunteer donation. The purpose of this study was to survey the improvement in likelihood of donation if participants were given the option of a topical anesthetic cream prior to venipuncture. Over a three month period 316 adults (convenience sample) completed a one page survey consisting of twelve questions pertaining to blood donation. Participants were asked about their likelihood of donating blood in the near future (No Possibility, Possible, Likely, Certain). They were then informed of the possibility of using a topical anesthetic cream prior to donation. Subsequently, their likelihood of donating blood was reassessed. Fifty (16%) subjects reported an increased likelihood of donating blood if offered a topical anesthetic (p〈0.0001). Of these respondents reporting an increase in donation likelihood, eleven improved by 2 or more likelihood categories. Amongst the 169 participants who never donated blood, 34 (20%) reported an increased likelihood of donation after being told about the topical anesthetic cream, compared to 16 (10%) of the 147 subjects who had previously donated blood (p=0.02). The findings of this study suggest that providing a topical anesthetic had a positive effect on the study participants' likelihood of donating blood. This improvement was greater amongst those who have never donated blood. Hawaii Medical Journal Copyright 2011.

Organ donation after medical assistance in dying or cessation of life-sustaining treatment requested by conscious patients: the Canadian context.

PubMed

Allard, Julie; Fortin, Marie-Chantal

2017-09-01

In June 2016, following the decision of the Supreme Court of Canada to decriminalise assistance in dying, the Canadian government enacted Bill C-14, legalising medical assistance in dying (MAID). In 2014, the province of Quebec had passed end-of-life care legislation making MAID available as of December 2015. The availability of MAID has many implications, including the possibility of combining this practice with organ donation through the controlled donation after cardiac death (cDCD) protocol. cDCD most often occurs in cases where the patient has a severe neurological injury but does not meet all the criteria for brain death. The donation is subsequent to the decision to withdraw life-sustaining treatment (LST). Cases where patients are conscious prior to the withdrawal of LST are unusual, and have raised doubts as to the acceptability of removing organs from individuals who are not neurologically impaired and who have voluntarily chosen to die. These cases can be compared with likely scenarios in which patients will request both MAID and organ donation. In both instances, patients will be conscious and competent. Organ donation in such contexts raises ethical issues regarding respect for autonomy, societal pressure, conscientious objections and the dead-donor rule. In this article, we look at relevant policies in other countries and examine the ethical issues associated with cDCD in conscious patients who choose to die. 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/.

[Outcome of living kidney donors for transplantation].

PubMed

Lanot, Antoine; Bouvier, Nicolas; Chatelet, Valérie; Lecouf, Angélique; Tillou, Xavier; Hurault de Ligny, Bruno

2017-11-01

Nowadays, several treatments exist to treat terminal chronic renal failure. Best results for the recipients are obtained with kidney transplantation concerning mortality and quality of life. Transplantation is also the cheaper option for society. Living kidney donation raises the issue of the becoming of the donor, an absolutely healthy subject who gets to a surgical procedure. The becoming of living kidney donors has been compared with the one of controls subjects in several studies. The evaluations focused on the complications of nephrectomy in the short and long-term: kidney failure, hypertension, proteinuria, possibility of pregnancy, quality of life, and mortality. The first results did not show any risk linked to kidney donation, compared to general population. However, since 2013, kidney donors were found at higher risk for kidney failure and even for mortality, compared with controls selected like donor candidates. The risk of kidney donation is nevertheless acceptable and minimal, on the condition of rigorous selection of candidates and regular follow-up. Copyright © 2017 Société francophone de néphrologie, dialyse et transplantation. Published by Elsevier Masson SAS. All rights reserved.

The Blood Donation Ambivalence Survey: measuring conflicting attitudes about giving blood.

PubMed

Fox, K R; Himawan, L K; France, C R

2017-05-18

This study was designed to develop and conduct initial validation testing for a novel measure of ambivalence about donating blood. Previous studies of living organ, bone marrow and stem cell donors have identified donation-related ambivalence as a predictor of decisions about donation and post-donation outcomes. Ambivalence about blood donation has not received the same attention. In Study 1, a sample of young adults (N = 396) were administered test items of ambivalence, and exploratory (EFA) and confirmatory factor analyses (CFA) were performed to identify the Blood Donation Ambivalence Survey. In Study 2, a separate sample of young adults (N = 241) completed the Blood Donation Ambivalence Survey in addition to questionnaires assessing known predictors of blood donation. Exploratory and confirmatory factor analyses indicated a two-factor structure reflecting commitment to donating blood and indecision about giving blood. The commitment subscale was positively related to known predictors of increased donation behaviour (e.g. donation intention, self-efficacy), whereas the indecision subscale was positively related to known predictors of decreased donation behaviour (e.g. donation anxiety, negative affect). Furthermore, a history of blood donation was associated with greater commitment and less indecision. The present findings provide strong initial support for the reliability and validity of a novel measure of blood donor ambivalence. © 2017 British Blood Transfusion Society.

Exploring the Effects of a Universal Classroom Management Training Programme on Teacher and Child Behaviour: A Group Randomised Controlled Trial and Cost Analysis

ERIC Educational Resources Information Center

Hickey, Grainne; McGilloway, Sinead; Hyland, Lynda; Leckey, Yvonne; Kelly, Paul; Bywater, Tracey; Comiskey, Catherine; Lodge, Anne; Donnelly, Michael; O'Neill, Donal

2017-01-01

Teachers frequently struggle to cope with conduct problems in the classroom. The aim of this study was to assess the effectiveness of the Incredible Years Teacher Classroom Management Training Programme for improving teacher competencies and child adjustment. The study involved a group randomised controlled trial which included 22 teachers and 217…

Educational Benefits of Using Game Consoles in a Primary Classroom: A Randomised Controlled Trial

ERIC Educational Resources Information Center

Miller, David J.; Robertson, Derek P.

2011-01-01

It is known that computer games are motivating for children, but there is limited direct evidence of their effects on classroom learning. The studies that are available tend to be limited in terms of output data reported, or small in scale, or both. The aim of this randomised controlled trial was to upscale a recent study by Miller and Robertson…

The Importance of Specifying and Studying Causal Mechanisms in School-Based Randomised Controlled Trials: Lessons from Two Studies of Cross-Age Peer Tutoring

ERIC Educational Resources Information Center

Morris, Stephen P.; Edovald, Triin; Lloyd, Cheryl; Kiss, Zsolt

2016-01-01

Based on the experience of evaluating 2 cross-age peer-tutoring interventions, we argue that researchers need to pay greater attention to causal mechanisms within the context of school-based randomised controlled trials. Without studying mechanisms, researchers are less able to explain the underlying causal processes that give rise to results from…

A Randomised Controlled Treatment Trial of Two Forms of Family Therapy in Adolescent Anorexia Nervosa: A Five-Year Follow-Up

ERIC Educational Resources Information Center

Eisler, Ivan; Simic, Mima; Russell, Gerald F. M.; Dare, Christopher

2007-01-01

Background: There is growing evidence that family therapy is an effective treatment for adolescent anorexia nervosa. This study aimed to ascertain the long-term impact of two forms of outpatient family intervention previously evaluated in a randomised controlled trial (RCT). Method: A five-year follow-up was conducted on a cohort of 40 patients…

A Randomised Controlled Trial Using Mobile Advertising to Promote Safer Sex and Sun Safety to Young People

ERIC Educational Resources Information Center

Gold, J.; Aitken, C. K.; Dixon, H. G.; Lim, M. S. C.; Gouillou, M.; Spelman, T.; Wakefield, M.; Hellard, M. E.

2011-01-01

Mobile phone text messages (SMS) are a promising method of health promotion, but a simple and low cost way to obtain phone numbers is required to reach a wide population. We conducted a randomised controlled trial with simultaneous brief interventions to (i) evaluate effectiveness of messages related to safer sex and sun safety and (ii) pilot the…

A Pilot Randomised Controlled Trial of a School-Based Resilience Intervention to Prevent Depressive Symptoms for Young Adolescents with Autism Spectrum Disorder: A Mixed Methods Analysis

ERIC Educational Resources Information Center

Mackay, Bethany A.; Shochet, Ian M.; Orr, Jayne A.

2017-01-01

Despite increased depression in adolescents with Autism Spectrum Disorder (ASD), effective prevention approaches for this population are limited. A mixed methods pilot randomised controlled trial (N = 29) of the evidence-based Resourceful Adolescent Program-Autism Spectrum Disorder (RAP-A-ASD) designed to prevent depression was conducted in…

A systematic review of randomised controlled trials on the effectiveness of exercise programs on Lumbo Pelvic Pain among postnatal women.

PubMed

Tseng, Pei-Ching; Puthussery, Shuby; Pappas, Yannis; Gau, Meei-Ling

2015-11-26

A substantial number of women tend to be affected by Lumbo Pelvic Pain (LPP) following child birth. Physical exercise is indicated as a beneficial method to relieve LPP, but individual studies appear to suggest mixed findings about its effectiveness. This systematic review aimed to synthesise evidence from randomised controlled trials on the effectiveness of exercise on LPP among postnatal women to inform policy, practice and future research. A systematic review was conducted of all randomised controlled trials published between January 1990 and July 2014, identified through a comprehensive search of following databases: PubMed, PEDro, Embase, Cinahl, Medline, SPORTDiscus, Cochrane Pregnancy and Childbirth Group's Trials Register, and electronic libraries of authors'institutions. Randomised controlled trials were eligible for inclusion if the intervention comprised of postnatal exercise for women with LPP onset during pregnancy or within 3 months after delivery and the outcome measures included changes in LPP. Selected articles were assessed using the PEDro Scale for methodological quality and findings were synthesised narratively as meta-analysis was found to be inappropriate due to heterogeneity among included studies. Four randomised controlled trials were included, involving 251 postnatal women. Three trials were rated as of 'good' methodological quality. All trials, except one, were at low risk of bias. The trials included physical exercise programs with varying components, differing modes of delivery, follow up times and outcome measures. Intervention in one trial, involving physical therapy with specific stabilising exercises, proved to be effective in reducing LPP intensity. An improvement in gluteal pain on the right side was reported in another trial and a significant difference in pain frequency in another. Our review indicates that only few randomised controlled trials have evaluated the effectiveness of exercise on LPP among postnatal women. There is also a great amount of variability across existing trials in the components of exercise programs, modes of delivery, follow up times and outcome measures. While there is some evidence to indicate the effectiveness of exercise for relieving LPP, further good quality trials are needed to ascertain the most effective elements of postnatal exercise programs suited for LPP treatment.

Moral stories emphasizing actors' negative emotions toward their nonhelping behavior promote preschoolers' helping behavior.

PubMed

Du, Xu; Hao, Jian

2018-04-01

Specific emotions, especially guilt, are considered to facilitate children's prosocial behavior. The current study differentiated moral stories with a helping theme in terms of the valence and source of emotions and aimed to clarify the effect of these stories on preschoolers' helping intentions and behavior. A total of 322 preschoolers between 4 and 6 years old were randomly assigned to four experimental groups and one control group. A specific type of moral story was presented to each of the experimental groups, whereas a nonmoral story was presented to the control group. The preschoolers were also asked to answer relevant questions to examine their story comprehension. The preschoolers' donating intentions and behavior were then measured. The results showed that all the experimental groups expressed more donating intentions than the control group. However, only the group that read the moral story emphasizing the actor's negative emotions toward his nonhelping behavior displayed more donating behavior than the control group. Therefore, the current study reveals that various moral stories dealing with a helping theme can facilitate helping intentions among preschoolers and that only certain stories can promote their helping behavior. Thus, it indicates the specificity of moral stories that facilitate prosocial behavior in terms of the valence and source of emotions in those stories. Copyright © 2017 Elsevier Inc. All rights reserved.

Short structured general mental health in service training programme in Kenya improves patient health and social outcomes but not detection of mental health problems - a pragmatic cluster randomised controlled trial

PubMed Central

2013-01-01

Trial design A pragmatic cluster randomised controlled trial. Methods Participants: Clusters were primary health care clinics on the Ministry of Health list. Clients were eligible if they were aged 18 and over. Interventions: Two members of staff from each intervention clinic received the training programme. Clients in both intervention and control clinics subsequently received normal routine care from their health workers. Objective: To examine the impact of a mental health inservice training on routine detection of mental disorder in the clinics and on client outcomes. Outcomes: The primary outcome was the rate of accurate routine clinic detection of mental disorder and the secondary outcome was client recovery over a twelve week follow up period. Randomisation: clinics were randomised to intervention and control groups using a table of random numbers. Blinding: researchers and clients were blind to group assignment. Results Numbers randomised: 49 and 50 clinics were assigned to intervention and control groups respectively. 12 GHQ positive clients per clinic were identified for follow up. Numbers analysed: 468 and 478 clients were followed up for three months in intervention and control groups respectively. Outcome: At twelve weeks after training of the intervention group, the rate of accurate routine clinic detection of mental disorder was greater than 0 in 5% versus 0% of the intervention and control groups respectively, in both the intention to treat analysis (p = 0.50) and the per protocol analysis (p =0.50). Standardised effect sizes for client improvement were 0.34 (95% CI = (0.01,0.68)) for the General Health Questionnaire, 0.39 ((95% CI = (0.22, 0.61)) for the EQ and 0.49 (95% CI = (0.11,0.87)) for WHODAS (using ITT analysis); and 0.43 (95% CI = (0.09,0.76)) for the GHQ, 0.44 (95% CI = (0.22,0.65)) for the EQ and 0.58 (95% CI = (0.18,0.97)) for WHODAS (using per protocol analysis). Harms: None identified. Conclusion The training programme did not result in significantly improved recorded diagnostic rates of mental disorders in the routine clinic consultation register, but did have significant effects on patient outcomes in routine clinical practice. Trial registration International Standard Randomised Controlled Trial Number Register ISRCTN53515024. PMID:24188964

Theory of planned behaviour variables and objective walking behaviour do not show seasonal variation in a randomised controlled trial

PubMed Central

2014-01-01

Background Longitudinal studies have shown that objectively measured walking behaviour is subject to seasonal variation, with people walking more in summer compared to winter. Seasonality therefore may have the potential to bias the results of randomised controlled trials if there are not adequate statistical or design controls. Despite this there are no studies that assess the impact of seasonality on walking behaviour in a randomised controlled trial, to quantify the extent of such bias. Further there have been no studies assessing how season impacts on the psychological predictors of walking behaviour to date. The aim of the present study was to assess seasonal differences in a) objective walking behaviour and b) Theory of Planned Behaviour (TPB) variables during a randomised controlled trial of an intervention to promote walking. Methods 315 patients were recruited to a two-arm cluster randomised controlled trial of an intervention to promote walking in primary care. A series of repeated measures ANCOVAs were conducted to examine the effect of season on pedometer measures of walking behaviour and TPB measures, assessed immediately post-intervention and six months later. Hierarchical regression analyses were conducted to assess whether season moderated the prediction of intention and behaviour by TPB measures. Results There were no significant differences in time spent walking in spring/summer compared to autumn/winter. There was no significant seasonal variation in most TPB variables, although the belief that there will be good weather was significantly higher in spring/summer (F = 19.46, p < .001). Season did not significantly predict intention or objective walking behaviour, or moderate the effects of TPB variables on intention or behaviour. Conclusion Seasonality does not influence objectively measured walking behaviour or psychological variables during a randomised controlled trial. Consequently physical activity behaviour outcomes in trials will not be biased by the season in which they are measured. Previous studies may have overestimated the extent of seasonality effects by selecting the most extreme summer and winter months to assess PA. In addition, participants recruited to behaviour change interventions might have higher levels of motivation to change and are less affected by seasonal barriers. Trial registration Current Controlled Trials ISRCTN95932902 PMID:24499405

Antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease.

PubMed

Martí-Carvajal, Arturo J; Solà, Ivan

2015-06-09

Upper gastrointestinal bleeding is one of the most frequent causes of morbidity and mortality in the course of liver cirrhosis. People with liver disease frequently have haemostatic abnormalities such as hyperfibrinolysis. Therefore, antifibrinolytic amino acids have been proposed to be used as supplementary interventions alongside any of the primary treatments for upper gastrointestinal bleeding in people with liver diseases. This is an update of this Cochrane review. To assess the beneficial and harmful effects of antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease. We searched The Cochrane Hepato-Biliary Controlled Trials Register (February 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2 of 12, 2015), MEDLINE (Ovid SP) (1946 to February 2015), EMBASE (Ovid SP) (1974 to February 2015), Science Citation Index EXPANDED (1900 to February 2015), LILACS (1982 to February 2015), World Health Organization Clinical Trials Search Portal (accessed 26 February 2015), and the metaRegister of Controlled Trials (accessed 26 February 2015). We scrutinised the reference lists of the retrieved publications. Randomised clinical trials irrespective of blinding, language, or publication status for assessment of benefits and harms. Observational studies for assessment of harms. We planned to summarise data from randomised clinical trials using standard Cochrane methodologies and assessed according to the GRADE approach. We found no randomised clinical trials assessing antifibrinolytic amino acids for treating upper gastrointestinal bleeding in people with acute or chronic liver disease. We did not identify quasi-randomised, historically controlled, or observational studies in which we could assess harms. This updated Cochrane review identified no randomised clinical trials assessing the benefits and harms of antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease. The benefits and harms of antifibrinolytic amino acids need to be tested in randomised clinical trials. Unless randomised clinical trials are conducted to assess the trade-off between benefits and harms, we cannot recommend or refute antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver diseases.

A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

PubMed Central

2010-01-01

Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676 PMID:20398378

Twelve month follow-up on a randomised controlled trial of relaxation training for post-stroke anxiety.

PubMed

Golding, Katherine; Fife-Schaw, Chris; Kneebone, Ian

2017-09-01

To follow up participants in a randomised controlled trial of relaxation training for anxiety after stroke at 12 months. Twelve month follow-up to a randomised controlled trial, in which the control group also received treatment. Community. Fifteen of twenty one original participants with post-stroke anxiety participated in a one year follow-up study. A self-help autogenic relaxation CD listened to five times a week for one month, immediately in the intervention group and after three months in the control group. Hospital Anxiety and Depression Scale-Anxiety subscale and the Telephone Interview of Cognitive Status for inclusion. Hospital Anxiety and Depression Scale-Anxiety subscale for outcome. All measures were administered by phone. Anxiety ratings reduced significantly between pre and post-intervention, and between pre-intervention and one year follow-up ( χ 2 (2) = 22.29, p < 0.001). Reductions in anxiety in stroke survivors who received a self-help autogenic relaxation CD appear to be maintained after one year.

The effects of 2 weeks of interval vs continuous walking training on glycaemic control and whole-body oxidative stress in individuals with type 2 diabetes: a controlled, randomised, crossover trial.

PubMed

Karstoft, Kristian; Clark, Margaret A; Jakobsen, Ida; Müller, Ida A; Pedersen, Bente K; Solomon, Thomas P J; Ried-Larsen, Mathias

2017-03-01

The aim of this study was to evaluate the effects of oxygen consumption-matched short-term interval walking training (IWT) vs continuous walking training (CWT) on glycaemic control, including glycaemic variability, in individuals with type 2 diabetes. We also assessed whether any training-induced improvements in glycaemic control were associated with systemic oxidative stress levels. Participants (n = 14) with type 2 diabetes completed a crossover trial using three interventions (control intervention [CON], CWT and IWT), each lasting 2 weeks. These were performed in a randomised order (computerised generated randomisation) and separated by washout periods of 4 or 8 weeks after CON or training interventions, respectively. Training included ten supervised treadmill sessions, lasting 60 min/session, and was performed at the research facility. CWT was performed at moderate walking speed (75.6% ± 2.5% of walking peak oxygen consumption [[Formula: see text

The effect of intensive glucose control on all-cause and cardiovascular mortality, myocardial infarction and stroke in persons with type 2 diabetes mellitus: a systematic review and meta-analysis.

PubMed

Marso, Steven P; Kennedy, Kevin F; House, John A; McGuire, Darren K

2010-04-01

We performed a meta-analysis of studies evaluating the effect of intensive glucose control on major adverse cardiovascular events in patients with type 2 diabetes from 1990 to 2009. A search of the published literature and the Cochran Central Register for Controlled Trials was performed using pre-specified inclusion criteria consisting of randomised controlled trials evaluating intensive glycaemic control and reporting the individual endpoints of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke. Incident rate ratios for these endpoints were calculated using standard meta-analytic techniques of pooled data from eligible trials. Six reports from four randomised trials including 27,544 patients met the pre-specified inclusion criteria. Mean follow-up was 5.4 years; haemoglobin A(1C) at study end was 6.6% vs. 7.4% in patients randomised to intensive compared with conventional glucose control. Intensive glucose control did not affect the incident rate ratio for all-cause mortality (1.01, 95% confidence interval 0.86-1.18, p=0.54) or stroke (1.02, 95% confidence interval 0.88-1.20, p=0.62). However, there was a statistically significant 14% reduction in non-fatal myocardial infarction in patients randomised to intensive glucose control (0.86, 95% confidence interval 0.77-0.97, p=0.015). Although intensification of glucose control did not affect mortality or non-fatal stroke, the risk for non-fatal myocardial infarction was significantly reduced in patients with type 2 diabetes.

The challenge of recruiting people with schizophrenia to a health promotion trial

PubMed Central

Abbott, Margaret; Arthur, Antony; Walker, Liz; Doody, Gillian

2005-01-01

People with schizophrenia have an increased risk of coronary heart disease. This pilot study tested the feasibility of carrying out a randomised controlled trial to compare coronary heart disease prevention for this population through an enhanced occupational therapy support intervention versus a practice-based intervention. Difficulty in deciding whether to take part meant that 123 visits were made to 25 people with 12 ultimately providing informed consent. Participants' discussion at a subsequent focus group (n = 3) suggested a poor understanding of the study process. Distrust of randomisation suggests that randomised controlled trials may not be the best way to evaluate community-based interventions for people with schizophrenia. PMID:16105374

Acute pancreatitis: recent advances through randomised trials.

PubMed

van Dijk, Sven M; Hallensleben, Nora D L; van Santvoort, Hjalmar C; Fockens, Paul; van Goor, Harry; Bruno, Marco J; Besselink, Marc G

2017-11-01

Acute pancreatitis is one of the most common GI conditions requiring acute hospitalisation and has a rising incidence. In recent years, important insights on the management of acute pancreatitis have been obtained through numerous randomised controlled trials. Based on this evidence, the treatment of acute pancreatitis has gradually developed towards a tailored, multidisciplinary effort, with distinctive roles for gastroenterologists, radiologists and surgeons. This review summarises how to diagnose, classify and manage patients with acute pancreatitis, emphasising the evidence obtained through randomised controlled trials. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Interventions in the workplace to support breastfeeding for women in employment.

PubMed

Abdulwadud, Omar A; Snow, Mary Elizabeth

2012-10-17

In recent years there has been a rise in the participation rate of women in employment. Some may become pregnant while in employment and subsequently deliver their babies. Most may decide to return early to work after giving birth for various reasons. Unless these mothers get support from their employers and fellow employees, they might give up breastfeeding when they return to work. As a result, the duration and exclusivity of breastfeeding to the recommended age of the babies would be affected.Workplace environment can play a positive role to promote breastfeeding. For women going back to work, various types of workplace support interventions are available and this should not be ignored by employers. Notably, promoting breastfeeding in a workplace may have benefits for the women, the baby and also the employer. To assess the effectiveness of workplace interventions to support and promote breastfeeding among women returning to paid work after the birth of their children, and its impact on process outcomes pertinent to employees and employers. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (2 August 2012). Two authors independently assessed all identified studies for randomised controlled trials and quasi-randomised controlled trials that compared workplace interventions with no intervention or two or more workplace interventions against each other. Two authors planned to evaluate the methodological quality of the eligible trials and extract data. There were no randomised controlled trials or quasi-randomised controlled trials identified. No trials have evaluated the effectiveness of workplace interventions in promoting breastfeeding among women returning to paid work after the birth of their child. The impact of such intervention on process outcomes is also unknown. Randomised controlled trials are required to establish the benefits of various types of workplace interventions to support, encourage and promote breastfeeding among working mothers.

Antenatal peer support workers and initiation of breast feeding: cluster randomised controlled trial.

PubMed

MacArthur, Christine; Jolly, Kate; Ingram, Lucy; Freemantle, Nick; Dennis, Cindy-Lee; Hamburger, Ros; Brown, Julia; Chambers, Jackie; Khan, Khalid

2009-01-30

To assess the effectiveness of an antenatal service using community based breastfeeding peer support workers on initiation of breast feeding. Cluster randomised controlled trial. Community antenatal clinics in one primary care trust in a multiethnic, deprived population. 66 antenatal clinics with 2511 pregnant women: 33 clinics including 1140 women were randomised to receive the peer support worker service and 33 clinics including 1371 women were randomised to receive standard care. An antenatal peer support worker service planned to comprise a minimum of two contacts with women to provide advice, information, and support from approximately 24 weeks' gestation within the antenatal clinic or at home. The trained peer support workers were of similar ethnic and sociodemographic backgrounds to their clinic population. Initiation of breast feeding obtained from computerised maternity records of the hospitals where women from the primary care trust delivered. The sample was multiethnic, with only 9.4% of women being white British, and 70% were in the lowest 10th for deprivation. Most of the contacts with peer support workers took place in the antenatal clinics. Data on initiation of breast feeding were obtained for 2398 of 2511 (95.5%) women (1083/1140 intervention and 1315/1371 controls). The groups did not differ for initiation of breast feeding: 69.0% (747/1083) in the intervention group and 68.1% (896/1315) in the control groups; cluster adjusted odds ratio 1.11 (95% confidence interval 0.87 to 1.43). Ethnicity, parity, and mode of delivery independently predicted initiation of breast feeding, but randomisation to the peer support worker service did not. A universal service for initiation of breast feeding using peer support workers provided within antenatal clinics serving a multiethnic, deprived population was ineffective in increasing initiation rates. Current Controlled Trials ISRCTN16126175.

Preventing substance misuse: study protocol for a randomised controlled trial of the Strengthening Families Programme 10–14 UK (SFP 10–14 UK)

PubMed Central

2014-01-01

Background Prevention of alcohol, drug and tobacco misuse by young people is a key public health priority. There is a need to develop the evidence base through rigorous evaluations of innovative approaches to substance misuse prevention. The Strengthening Families Programme 10–14 is a universal family-based alcohol, drugs and tobacco prevention programme, which has achieved promising results in US trials, and which now requires cross-cultural assessment. This paper therefore describes the protocol for a randomised controlled trial of the UK version of the Strengthening Families Programme 10–14 (SFP 10–14 UK). Methods/Design The trial comprises a pragmatic cluster randomised controlled effectiveness trial with families as the unit of randomisation, with embedded process and economic evaluations. Participating families will be randomised to one of two treatment groups - usual care with full access to existing services (control group), or usual care plus SFP 10–14 UK (intervention group). The trial has two primary outcomes - the number of occasions that young people report having drunk alcohol in the last 30 days, and drunkenness during the last 30 days, both dichotomised as ‘never’ and ‘1-2 times or more’. The main follow-up is at 2 years past baseline, and short-term and intermediate outcomes are also measured at 9 and 15 months. Discussion The results from this trial will provide evidence on the effectiveness and cost-effectiveness of an innovative universal family-based substance misuse prevention programme in a UK context. Trial registration Current Controlled Trials ISRCTN63550893. PMID:24438460

Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2).

PubMed

Bullens, Lauren M; Hulsenboom, Alexandra D J; Moors, Suzanne; Joshi, Rohan; van Runnard Heimel, Pieter J; van der Hout-van der Jagt, M Beatrijs; van den Heuvel, Edwin R; Guid Oei, S

2018-03-23

Perinatal asphyxia is, even in developed countries, one the major causes of neonatal morbidity and mortality. Therefore, if foetal distress during labour is suspected, one should try to restore foetal oxygen levels or aim for immediate delivery. However, studies on the effect of intrauterine resuscitation during labour are scarce. We designed a randomised controlled trial to investigate the effect of maternal hyperoxygenation on the foetal condition. In this study, maternal hyperoxygenation is induced for the treatment of foetal distress during the second stage of term labour. This study is a single-centre randomised controlled trial being performed in a tertiary hospital in The Netherlands. From among cases of a suboptimal or abnormal foetal heart rate pattern during the second stage of term labour, a total of 116 patients will be randomised to the control group, where normal care is provided, or to the intervention group, where before normal care 100% oxygen is supplied to the mother by a non-rebreathing mask until delivery. The primary outcome is change in foetal heart rate pattern. Secondary outcomes are Apgar score, mode of delivery, admission to the neonatal intensive care unit and maternal side effects. In addition, blood gas values and malondialdehyde are determined in umbilical cord blood. This study will be the first randomised controlled trial to investigate the effect of maternal hyperoxygenation for foetal distress during labour. This intervention should be recommended only as a treatment for intrapartum foetal distress, when improvement of the foetal condition is likely and outweighs maternal and neonatal side effects. EudraCT, 2015-001654-15; registered on 3 April 2015. Dutch Trial Register, NTR5461; registered on 20 October 2015.

Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial.

PubMed

Al-Lamee, Rasha; Thompson, David; Dehbi, Hakim-Moulay; Sen, Sayan; Tang, Kare; Davies, John; Keeble, Thomas; Mielewczik, Michael; Kaprielian, Raffi; Malik, Iqbal S; Nijjer, Sukhjinder S; Petraco, Ricardo; Cook, Christopher; Ahmad, Yousif; Howard, James; Baker, Christopher; Sharp, Andrew; Gerber, Robert; Talwar, Suneel; Assomull, Ravi; Mayet, Jamil; Wensel, Roland; Collier, David; Shun-Shin, Matthew; Thom, Simon A; Davies, Justin E; Francis, Darrel P

2018-01-06

Symptomatic relief is the primary goal of percutaneous coronary intervention (PCI) in stable angina and is commonly observed clinically. However, there is no evidence from blinded, placebo-controlled randomised trials to show its efficacy. ORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief that was done at five study sites in the UK. We enrolled patients with severe (≥70%) single-vessel stenoses. After enrolment, patients received 6 weeks of medication optimisation. Patients then had pre-randomisation assessments with cardiopulmonary exercise testing, symptom questionnaires, and dobutamine stress echocardiography. Patients were randomised 1:1 to undergo PCI or a placebo procedure by use of an automated online randomisation tool. After 6 weeks of follow-up, the assessments done before randomisation were repeated at the final assessment. The primary endpoint was difference in exercise time increment between groups. All analyses were based on the intention-to-treat principle and the study population contained all participants who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT02062593. ORBITA enrolled 230 patients with ischaemic symptoms. After the medication optimisation phase and between Jan 6, 2014, and Aug 11, 2017, 200 patients underwent randomisation, with 105 patients assigned PCI and 95 assigned the placebo procedure. Lesions had mean area stenosis of 84·4% (SD 10·2), fractional flow reserve of 0·69 (0·16), and instantaneous wave-free ratio of 0·76 (0·22). There was no significant difference in the primary endpoint of exercise time increment between groups (PCI minus placebo 16·6 s, 95% CI -8·9 to 42·0, p=0·200). There were no deaths. Serious adverse events included four pressure-wire related complications in the placebo group, which required PCI, and five major bleeding events, including two in the PCI group and three in the placebo group. In patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure. The efficacy of invasive procedures can be assessed with a placebo control, as is standard for pharmacotherapy. NIHR Imperial Biomedical Research Centre, Foundation for Circulatory Health, Imperial College Healthcare Charity, Philips Volcano, NIHR Barts Biomedical Research Centre. Copyright © 2018 Elsevier Ltd. All rights reserved.

Promoting Recruitment using Information Management Efficiently (PRIME): a stepped-wedge, cluster randomised trial of a complex recruitment intervention embedded within the REstart or Stop Antithrombotics Randomised Trial.

PubMed

Maxwell, Amy E; Parker, Richard A; Drever, Jonathan; Rudd, Anthony; Dennis, Martin S; Weir, Christopher J; Al-Shahi Salman, Rustam

2017-12-28

Few interventions are proven to increase recruitment in clinical trials. Recruitment to RESTART, a randomised controlled trial of secondary prevention after stroke due to intracerebral haemorrhage, has been slower than expected. Therefore, we sought to investigate an intervention to boost recruitment to RESTART. We conducted a stepped-wedge, cluster randomised trial of a complex intervention to increase recruitment, embedded within the RESTART trial. The primary objective was to investigate if the PRIME complex intervention (a recruitment co-ordinator who conducts a recruitment review, provides access to bespoke stroke audit data exports, and conducts a follow-up review after 6 months) increases the recruitment rate to RESTART. We included 72 hospital sites located in England, Wales, or Scotland that were active in RESTART in June 2015. All sites began in the control state and were allocated using block randomisation stratified by hospital location (Scotland versus England/Wales) to start the complex intervention in one of 12 different months. The primary outcome was the number of patients randomised into RESTART per month per site. We quantified the effect of the complex intervention on the primary outcome using a negative binomial, mixed model adjusting for site, December/January months, site location, and background time trends in recruitment rate. We recruited and randomised 72 sites and recorded their monthly recruitment to RESTART over 24 months (March 2015 to February 2017 inclusive), providing 1728 site-months of observations for the primary analysis. The adjusted rate ratio for the number of patients randomised per month after allocation to the PRIME complex intervention versus control time before allocation to the PRIME complex intervention was 1.06 (95% confidence interval 0.55 to 2.03, p = 0.87). Although two thirds of respondents to the 6-month follow-up questionnaire agreed that the audit reports were useful, only six patients were reported to have been randomised using the audit reports. Respondents frequently reported resource and time pressures as being key barriers to running the audit reports. The PRIME complex intervention did not significantly improve the recruitment rate to RESTART. Further research is needed to establish if PRIME might be beneficial at an earlier stage in a prevention trial or for prevention dilemmas that arise more often in clinical practice.

Specialist teams for neonatal transport to neonatal intensive care units for prevention of morbidity and mortality.

PubMed

Chang, Alvin S M; Berry, Andrew; Jones, Lisa J; Sivasangari, Subramaniam

2015-10-28

Maternal antenatal transfers provide better neonatal outcomes. However, there will inevitably be some infants who require acute transport to a neonatal intensive care unit (NICU). Because of this, many institutions develop services to provide neonatal transport by specially trained health personnel. However, few studies report on relevant clinical outcomes in infants requiring transport to NICU. To determine the effects of specialist transport teams compared with non-specialist transport teams on the risk of neonatal mortality and morbidity among high-risk newborn infants requiring transport to neonatal intensive care. We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 7), MEDLINE (1966 to 31 July 2015), EMBASE (1980 to 31 July 2015), CINAHL (1982 to 31 July 2015), conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. randomised, quasi-randomised or cluster randomised controlled trials. neonates requiring transport to a neonatal intensive care unit. transport by a specialist team compared to a non-specialist team. any of the following outcomes - death; adverse events during transport leading to respiratory compromise; and condition on admission to the neonatal intensive care unit. The methodological quality of the trials was assessed using the information provided in the studies and by personal communication with the author. Data on relevant outcomes were extracted and the effect size estimated and reported as risk ratio (RR), risk difference (RD), number needed to treat for an additional beneficial outcome (NNTB) or number needed to treat for an additional harmful outcome (NNTH) and mean difference (MD) for continuous outcomes. Data from cluster randomised trials were not combined for analysis. One trial met the inclusion criteria of this review but was considered ineligible owing to serious bias in the reporting of the results. There is no reliable evidence from randomised trials to support or refute the effects of specialist neonatal transport teams for neonatal retrieval on infant morbidity and mortality. Cluster randomised trial study designs may be best suited to provide us with answers on effectiveness and clinical outcomes.

Outcomes of pregnancies achieved by double gamete donation: A comparison with pregnancies obtained by oocyte donation alone.

PubMed

Preaubert, Lise; Vincent-Rohfritsch, Aurélie; Santulli, Pietro; Gayet, Vanessa; Goffinet, François; Le Ray, Camille

2018-03-01

Women increasingly resort to oocyte donation to become pregnant. The high risk of preeclampsia found in oocyte donation pregnancies and the separate risk of preeclampsia associated with sperm donation may be cumulative in double donation pregnancies. We aimed to study the obstetrical and perinatal outcomes of pregnancies obtained by double donation (both oocyte and sperm) in comparison with those obtained by oocyte donation alone (oocyte donation and partner's sperm). This cohort study included all women aged 43 and older who became pregnant after oocyte donation and gave birth between 2010 and 2016 in a tertiary maternity center. Primary outcomes were preeclampsia and hypertensive gestational disorders. Secondary outcomes were gestational diabetes, placental abnormalities, postpartum hemorrhage, perinatal death, and preterm delivery. We used univariate and multivariate analysis to compare IVF with double donation and IVF with oocyte donation alone for obstetric and perinatal outcomes. 247 women, 53 with double donations and 194 with oocyte donations alone, gave birth to 339 children. We observed no significant differences between groups for any obstetric or perinatal complications, except for the risk of gestational diabetes, which was more frequent in women with double donations compared with oocyte donation alone (26.4% vs. 12.9%, P = 0.02) and remained significant after adjustment (aOR = 2.80 95%CI[1.26-6.17]). Rates of gestational hypertension and preeclampsia were high, but similar between groups (20.7% vs. 26.3%, P = 0.41, and 18.9% vs. 17.5%, P = 0.82). Women undergoing oocyte donation should be fully informed of its high rates of obstetric and perinatal risks. However, except for a higher observed risk of gestational diabetes, double donation does not appear to be associated with a higher risk of complications than oocyte donation alone. Copyright © 2017 Elsevier B.V. All rights reserved.

Kidney donation after circulatory death in a country with a high number of brain dead donors: 10-year experience in Belgium.

PubMed

Jochmans, Ina; Darius, Tom; Kuypers, Dirk; Monbaliu, Diethard; Goffin, Eric; Mourad, Michel; Ledinh, Hieu; Weekers, Laurent; Peeters, Patrick; Randon, Caren; Bosmans, Jean-Louis; Roeyen, Geert; Abramowicz, Daniel; Hoang, Anh-Dung; De Pauw, Luc; Rahmel, Axel; Squifflet, Jean-Paul; Pirenne, Jacques

2012-08-01

Worldwide shortage of standard brain dead donors (DBD) has revived the use of kidneys donated after circulatory death (DCD). We reviewed the Belgian DCD kidney transplant (KT) experience since its reintroduction in 2000. Risk factors for delayed graft function (DGF) were identified using multivariate analysis. Five-year patient/graft survival was assessed using Kaplan-Meier curves. The evolution of the kidney donor type and the impact of DCDs on the total KT activity in Belgium were compared with the Netherlands. Between 2000 and 2009, 287 DCD KT were performed. Primary nonfunction occurred in 1% and DGF in 31%. Five-year patient and death-censored graft survival were 93% and 95%, respectively. In multivariate analysis, cold storage (versus machine perfusion), cold ischemic time, and histidine-tryptophan-ketoglutarate solution were independent risk factors for the development of DGF. Despite an increased number of DCD donations and transplantations, the total number of deceased KT did not increase significantly. This could suggest a shift from DBDs to DCDs. To increase KT activity, Belgium should further expand controlled DCD programs while simultaneously improve the identification of all potential DBDs and avoid their referral for donation as DCDs before brain death occurs. Furthermore, living donation remains underused. © 2012 The Authors. Transplant International © 2012 European Society for Organ Transplantation.

A pilot iron substitution programme in female blood donors with iron deficiency without anaemia.

PubMed

Pittori, C; Buser, A; Gasser, U E; Sigle, J; Job, S; Rüesch, M; Tichelli, A; Infanti, L

2011-04-01

Blood donation can contribute to iron deficiency. The possibly resulting anaemia importantly affects donor return rate. The determination of serum ferritin levels revealed iron deficiency in many non-anaemic premenopausal female blood donors at our Institution. We started an iron substitution programme targeting this donor group to prevent anaemia and enhance donor retain. Women aged≤50 with haemoglobin levels adequate for donation and serum ferritin≤10 ng/ml were offered iron supplementation. Substitution lasted 16 weeks and the donation interval was extended. History collection including iron deficiency-related symptoms, whole blood count and serum ferritin determination was performed at baseline and after 2 and 6 months. Data were recorded prospectively and compared with those of 108 female controls with iron deficiency not receiving iron substitution (retrospective data). Of the 116 participating subjects, 60% completed the programme. Significant results were serum ferritin increase (from a mean value of 7.12 to 25.2 ng/ml), resolution of prostration, fatigue, sleep disturbances, tension in the neck, hair loss and nail breakage. No case of anaemia occurred. Sixty per cent of the women completed the programme and donated blood again. Targeted iron substitution prevents the development of anaemia and enhances donation return in premenopausal female blood donors with iron deficiency. © 2010 The Author(s). Vox Sanguinis © 2010 International Society of Blood Transfusion.

15 CFR 740.12 - Gift parcels and humanitarian donations (GFT).

Code of Federal Regulations, 2011 CFR

2011-01-01

..., and nuclear nonproliferation, missile technology or crime control reasons (see supplement No. 1 to... destinations, no items controlled for chemical and biological weapons (CB), missile technology (MT), national security (NS), nuclear proliferation (NP) or encryption items (EI) reasons on the Commerce Control List...

15 CFR 740.12 - Gift parcels and humanitarian donations (GFT).

Code of Federal Regulations, 2010 CFR

2010-01-01

..., and nuclear nonproliferation, missile technology or crime control reasons (see Supplement No. 1 to... destinations, no items controlled for chemical and biological weapons (CB), missile technology (MT), national security (NS), nuclear proliferation (NP) or encryption items (EI) reasons on the Commerce Control List...

The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Despite recent advances in acute stroke treatment, basilar artery occlusion (BAO) is associated with a death or disability rate of close to 70%. Randomised trials have shown the safety and efficacy of intravenous thrombolysis (IVT) given within 4.5 h and have shown promising results of intra-arterial thrombolysis given within 6 h of symptom onset of acute ischaemic stroke, but these results do not directly apply to patients with an acute BAO because only few, if any, of these patients were included in randomised acute stroke trials. Recently the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with acute symptomatic BAO challenged the often-held assumption that intra-arterial treatment (IAT) is superior to IVT. Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Design BASICS is a randomised controlled, multicentre, open label, phase III intervention trial with blinded outcome assessment, investigating the efficacy and safety of additional IAT after IVT in patients with BAO. The trial targets to include 750 patients, aged 18 to 85 years, with CT angiography or MR angiography confirmed BAO treated with IVT. Patients will be randomised between additional IAT followed by optimal medical care versus optimal medical care alone. IVT has to be initiated within 4.5 h from estimated time of BAO and IAT within 6 h. The primary outcome parameter will be favourable outcome at day 90 defined as a modified Rankin Scale score of 0–3. Discussion The BASICS registry was observational and has all the limitations of a non-randomised study. As the IAT approach becomes increasingly available and frequently utilised an adequately powered randomised controlled phase III trial investigating the added value of this therapy in patients with an acute symptomatic BAO is needed (clinicaltrials.gov: NCT01717755). PMID:23835026

Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

PubMed Central

Eaton, Simon; Abbo, Olivier; Arnaud, Alexis P; Beaudin, Marianne; Brindle, Mary; Bütter, Andreana; Davies, Dafydd; Jancelewicz, Tim; Johnson, Kathy; Keijzer, Richard; Lapidus-Krol, Eveline; Offringa, Martin; Piché, Nelson; Rintala, Risto; Skarsgard, Erik; Svensson, Jan F; Ungar, Wendy J; Wester, Tomas; Willan, Andrew R; Zani, Augusto; St Peter, Shawn D; Pierro, Agostino

2017-01-01

Background Appendectomy is considered the gold standard treatment for acute appendicitis. Recently the need for surgery has been challenged in both adults and children. In children there is growing clinician, patient and parental interest in non-operative treatment of acute appendicitis with antibiotics as opposed to surgery. To date no multicentre randomised controlled trials that are appropriately powered to determine efficacy of non-operative treatment (antibiotics) for acute appendicitis in children compared with surgery (appendectomy) have been performed. Methods Multicentre, international, randomised controlled trial with a non-inferiority design. Children (age 5–16 years) with a clinical and/or radiological diagnosis of acute uncomplicated appendicitis will be randomised (1:1 ratio) to receive either laparoscopic appendectomy or treatment with intravenous (minimum 12 hours) followed by oral antibiotics (total course 10 days). Allocation to groups will be stratified by gender, duration of symptoms (> or <48 hours) and centre. Children in both treatment groups will follow a standardised treatment pathway. Primary outcome is treatment failure defined as additional intervention related to appendicitis requiring general anaesthesia within 1 year of randomisation (including recurrent appendicitis) or negative appendectomy. Important secondary outcomes will be reported and a cost-effectiveness analysis will be performed. The primary outcome will be analysed on a non-inferiority basis using a 20% non-inferiority margin. Planned sample size is 978 children. Discussion The APPY trial will be the first multicentre randomised trial comparing non-operative treatment with appendectomy for acute uncomplicated appendicitis in children. The results of this trial have the potential to revolutionise the treatment of this common gastrointestinal emergency. The randomised design will limit the effect of bias on outcomes seen in other studies. Trial registration number clinicaltrials.gov: NCT02687464. Registered on Jan 13th 2016. PMID:29637088

Prostate cancer mortality reduction by prostate-specific antigen-based screening adjusted for nonattendance and contamination in the European Randomised Study of Screening for Prostate Cancer (ERSPC).

PubMed

Roobol, Monique J; Kerkhof, Melissa; Schröder, Fritz H; Cuzick, Jack; Sasieni, Peter; Hakama, Matti; Stenman, Ulf Hakan; Ciatto, Stefano; Nelen, Vera; Kwiatkowski, Maciej; Lujan, Marcos; Lilja, Hans; Zappa, Marco; Denis, Louis; Recker, Franz; Berenguer, Antonio; Ruutu, Mirja; Kujala, Paula; Bangma, Chris H; Aus, Gunnar; Tammela, Teuvo L J; Villers, Arnauld; Rebillard, Xavier; Moss, Sue M; de Koning, Harry J; Hugosson, Jonas; Auvinen, Anssi

2009-10-01

Prostate-specific antigen (PSA) based screening for prostate cancer (PCa) has been shown to reduce prostate specific mortality by 20% in an intention to screen (ITS) analysis in a randomised trial (European Randomised Study of Screening for Prostate Cancer [ERSPC]). This effect may be diluted by nonattendance in men randomised to the screening arm and contamination in men randomised to the control arm. To assess the magnitude of the PCa-specific mortality reduction after adjustment for nonattendance and contamination. We analysed the occurrence of PCa deaths during an average follow-up of 9 yr in 162,243 men 55-69 yr of age randomised in seven participating centres of the ERSPC. Centres were also grouped according to the type of randomisation (ie, before or after informed written consent). Nonattendance was defined as nonattending the initial screening round in ERSPC. The estimate of contamination was based on PSA use in controls in ERSPC Rotterdam. Relative risks (RRs) with 95% confidence intervals (CIs) were compared between an ITS analysis and analyses adjusting for nonattendance and contamination using a statistical method developed for this purpose. In the ITS analysis, the RR of PCa death in men allocated to the intervention arm relative to the control arm was 0.80 (95% CI, 0.68-0.96). Adjustment for nonattendance resulted in a RR of 0.73 (95% CI, 0.58-0.93), and additional adjustment for contamination using two different estimates led to estimated reductions of 0.69 (95% CI, 0.51-0.92) to 0.71 (95% CI, 0.55-0.93), respectively. Contamination data were obtained through extrapolation of single-centre data. No heterogeneity was found between the groups of centres. PSA screening reduces the risk of dying of PCa by up to 31% in men actually screened. This benefit should be weighed against a degree of overdiagnosis and overtreatment inherent in PCa screening.

41 CFR 102-37.30 - When does property become available for donation?

Code of Federal Regulations, 2010 CFR

2010-07-01

... become available for donation? 102-37.30 Section 102-37.30 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.30 When does property become available for donation? Excess personal property becomes available for donation the day...

41 CFR 102-37.30 - When does property become available for donation?

Code of Federal Regulations, 2012 CFR

2012-01-01

... become available for donation? 102-37.30 Section 102-37.30 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.30 When does property become available for donation? Excess personal property becomes available for donation the day...

41 CFR 102-37.30 - When does property become available for donation?

Code of Federal Regulations, 2011 CFR

2011-01-01

... become available for donation? 102-37.30 Section 102-37.30 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.30 When does property become available for donation? Excess personal property becomes available for donation the day...

41 CFR 102-37.30 - When does property become available for donation?

Code of Federal Regulations, 2014 CFR

2014-01-01

... become available for donation? 102-37.30 Section 102-37.30 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.30 When does property become available for donation? Excess personal property becomes available for donation the day...

41 CFR 102-37.30 - When does property become available for donation?

Code of Federal Regulations, 2013 CFR

2013-07-01

... become available for donation? 102-37.30 Section 102-37.30 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.30 When does property become available for donation? Excess personal property becomes available for donation the day...

Supermarket Healthy Eating for Life (SHELf): protocol of a randomised controlled trial promoting healthy food and beverage consumption through price reduction and skill-building strategies

PubMed Central

2011-01-01

Background In the context of rising food prices, there is a need for evidence on the most effective approaches for promoting healthy eating. Individually-targeted behavioural interventions for increasing food-related skills show promise, but are unlikely to be effective in the absence of structural supports. Fiscal policies have been advocated as a means of promoting healthy eating and reducing obesity and nutrition-related disease, but there is little empirical evidence of their effectiveness. This paper describes the Supermarket Healthy Eating for LiFe (SHELf) study, a randomised controlled trial to investigate effectiveness and cost-effectiveness of a tailored skill-building intervention and a price reduction intervention, separately and in combination, against a control condition for promoting purchase and consumption of healthy foods and beverages in women from high and low socioeconomic groups. Methods/design SHELf comprises a randomised controlled trial design, with participants randomised to receive either (1) a skill-building intervention; (2) price reductions on fruits, vegetables and low-joule soft drink beverages and water; (3) a combination of skill-building and price reductions; or (4) a control condition. Five hundred women from high and low socioeconomic areas will be recruited through a store loyalty card program and local media. Randomisation will occur on receipt of informed consent and baseline questionnaire. An economic evaluation from a societal perspective using a cost-consequences approach will compare the costs and outcomes between intervention and control groups. Discussion This study will build on a pivotal partnership with a major national supermarket chain and the Heart Foundation to investigate the effectiveness of intervention strategies aimed at increasing women's purchasing and consumption of fruits and vegetables and decreased purchasing and consumption of sugar-sweetened beverages. It will be among the first internationally to examine the effects of two promising approaches - skill-building and price reductions - on diet amongst women. Trial Registration Current Controlled Trials ISRCTN39432901 PMID:21936957

Supermarket Healthy Eating for Life (SHELf): protocol of a randomised controlled trial promoting healthy food and beverage consumption through price reduction and skill-building strategies.

PubMed

Ball, Kylie; McNaughton, Sarah A; Mhurchu, Cliona Ni; Andrianopoulos, Nick; Inglis, Victoria; McNeilly, Briohny; Le, Ha N D; Leslie, Deborah; Pollard, Christina; Crawford, David

2011-09-22

In the context of rising food prices, there is a need for evidence on the most effective approaches for promoting healthy eating. Individually-targeted behavioural interventions for increasing food-related skills show promise, but are unlikely to be effective in the absence of structural supports. Fiscal policies have been advocated as a means of promoting healthy eating and reducing obesity and nutrition-related disease, but there is little empirical evidence of their effectiveness. This paper describes the Supermarket Healthy Eating for LiFe (SHELf) study, a randomised controlled trial to investigate effectiveness and cost-effectiveness of a tailored skill-building intervention and a price reduction intervention, separately and in combination, against a control condition for promoting purchase and consumption of healthy foods and beverages in women from high and low socioeconomic groups. SHELf comprises a randomised controlled trial design, with participants randomised to receive either (1) a skill-building intervention; (2) price reductions on fruits, vegetables and low-joule soft drink beverages and water; (3) a combination of skill-building and price reductions; or (4) a control condition. Five hundred women from high and low socioeconomic areas will be recruited through a store loyalty card program and local media. Randomisation will occur on receipt of informed consent and baseline questionnaire. An economic evaluation from a societal perspective using a cost-consequences approach will compare the costs and outcomes between intervention and control groups. This study will build on a pivotal partnership with a major national supermarket chain and the Heart Foundation to investigate the effectiveness of intervention strategies aimed at increasing women's purchasing and consumption of fruits and vegetables and decreased purchasing and consumption of sugar-sweetened beverages. It will be among the first internationally to examine the effects of two promising approaches - skill-building and price reductions - on diet amongst women. Current Controlled Trials ISRCTN39432901.

Application of implicit attitude measures to the blood donation context.

PubMed

Warfel, Regina M; France, Christopher R; France, Janis L

2012-02-01

Past blood donation research has relied on explicit (self-report) measures to understand blood donation motivations, but has not yet considered the inherent implicit or automatic processing involved in decision-making. This study addresses this limitation by introducing and validating two novel implicit measures of blood donation attitudes. Healthy young adults (n = 253) performed both image and word versions of a Single Target Implicit Association Test (ST-IAT) and then completed self-report measures of blood donation attitudes, blood and needle fears, social desirability, and donation intention. These results affirmed the validity of the blood donation ST-IATs in at least three ways. First, as expected, nondonors demonstrated more negative implicit donation attitudes than donors. Second, the implicit measures were significantly related in expected directions with explicit measures of donation attitudes as well as blood and needle fears. Finally, implicit donation attitudes were significantly related to donation intention, and the Image ST-IAT (but not the Word ST-IAT) significantly enhanced prediction of donation intention over and above needle fears and marginally enhanced prediction over and above blood fears. Image and word versions of the blood donation ST-IAT offer a valid method of assessing underlying automatic attitudes toward blood donation. © 2012 American Association of Blood Banks.

Pre-donation cognitions of potential living organ donors: the development of the Donation Cognition Instrument in potential kidney donors.

PubMed

Wirken, Lieke; van Middendorp, Henriët; Hooghof, Christina W; Sanders, Jan-Stephan F; Dam, Ruth E; van der Pant, Karlijn A M I; Berendsen, Elsbeth C M; Wellink, Hiske; Dackus, Henricus J A; Hoitsma, Andries J; Hilbrands, Luuk B; Evers, Andrea W M

2017-03-01

Cognitions surrounding living organ donation, including the motivation to donate, expectations of donation and worries about donation, are relevant themes during living donor evaluation. However, there is no reliable psychometric instrument assessing all these different cognitions. This study developed and validated a questionnaire to assess pre-donation motivations, expectations and worries regarding donation, entitled the Donation Cognition Instrument (DCI). Psychometric properties of the DCI were examined using exploratory factor analysis for scale structure and associations with validated questionnaires for construct validity assessment. From seven Dutch transplantation centres, 719 potential living kidney donors were included. The DCI distinguishes cognitions about donor benefits, recipient benefits, idealistic incentives, gratitude and worries about donation (Cronbach's alpha 0.76-0.81). Scores on pre-donation cognitions differed with regard to gender, age, marital status, religion and donation type. With regard to construct validity, the DCI was moderately correlated with expectations regarding donor's personal well-being and slightly to moderately to health-related quality of life. The DCI is found to be a reliable instrument assessing cognitions surrounding living organ donation, which might add to pre-donation quality of life measures in facilitating psychosocial donor evaluation by healthcare professionals. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Lung Quality and Utilization in Controlled Donation After Circulatory Determination of Death Within the United States.

PubMed

Mooney, J J; Hedlin, H; Mohabir, P K; Vazquez, R; Nguyen, J; Ha, R; Chiu, P; Patel, K; Zamora, M R; Weill, D; Nicolls, M R; Dhillon, G S

2016-04-01

Although controlled donation after circulatory determination of death (cDCDD) could increase the supply of donor lungs within the United States, the yield of lungs from cDCDD donors remains low compared with donation after neurologic determination of death (DNDD). To explore the reason for low lung yield from cDCDD donors, Scientific Registry of Transplant Recipient data were used to assess the impact of donor lung quality on cDCDD lung utilization by fitting a logistic regression model. The relationship between center volume and cDCDD use was assessed, and the distance between center and donor hospital was calculated by cDCDD status. Recipient survival was compared using a multivariable Cox regression model. Lung utilization was 2.1% for cDCDD donors and 21.4% for DNDD donors. Being a cDCDD donor decreased lung donation (adjusted odds ratio 0.101, 95% confidence interval [CI] 0.085-0.120). A minority of centers have performed cDCDD transplant, with higher volume centers generally performing more cDCDD transplants. There was no difference in center-to-donor distance or recipient survival (adjusted hazard ratio 1.03, 95% CI 0.78-1.37) between cDCDD and DNDD transplants. cDCDD lungs are underutilized compared with DNDD lungs after adjusting for lung quality. Increasing transplant center expertise and commitment to cDCDD lung procurement is needed to improve utilization. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

Knowledge, Attitudes, Practices, and Factors Associated with Voluntary Blood Donation among University Students in Kilimanjaro, Tanzania

PubMed Central

Elias, Elionora; Philemon, Rune N.; Damian, Damian J.; Msuya, Sia E.

2016-01-01

Background. Understanding the knowledge and awareness of blood donation among potential blood donors in the population, like young people, and the associated attitudes and practices is important. Methodology. This was a cross-sectional study whereby a self-administered questionnaire was used to collect information from the consenting participants. Results. A total of 422 participants were enrolled. Their mean age was 24.2 (SD 3.6) years. Of the 422, 30% have ever donated blood. 55% of those who had ever donated were repeated blood donors. Majority of the participants (93%) had positive attitudes towards blood donation and 88% were willing to donate in the future. Factors that were significantly associated with ever donating blood were male gender, knowing a person who has donated blood, knowledge of the amount of blood donated, willingness to donate in the future, and not expecting any postdonation reward. Discussion. High awareness, positive attitude, and high intention to donate in the future should be used to underscore the need to educate the young people on the value of blood donation in saving lives and to give them correct information on overall requirements for blood donation. PMID:28070449

Knowledge, Attitudes, Practices, and Factors Associated with Voluntary Blood Donation among University Students in Kilimanjaro, Tanzania.

PubMed

Elias, Elionora; Mauka, Wilhellmuss; Philemon, Rune N; Damian, Damian J; Mahande, Michael J; Msuya, Sia E

2016-01-01

Background . Understanding the knowledge and awareness of blood donation among potential blood donors in the population, like young people, and the associated attitudes and practices is important. Methodology . This was a cross-sectional study whereby a self-administered questionnaire was used to collect information from the consenting participants. Results . A total of 422 participants were enrolled. Their mean age was 24.2 (SD 3.6) years. Of the 422, 30% have ever donated blood. 55% of those who had ever donated were repeated blood donors. Majority of the participants (93%) had positive attitudes towards blood donation and 88% were willing to donate in the future. Factors that were significantly associated with ever donating blood were male gender, knowing a person who has donated blood, knowledge of the amount of blood donated, willingness to donate in the future, and not expecting any postdonation reward. Discussion . High awareness, positive attitude, and high intention to donate in the future should be used to underscore the need to educate the young people on the value of blood donation in saving lives and to give them correct information on overall requirements for blood donation.

Eye donation - awareness and willingness among attendants of patients at various clinics in Melaka, Malaysia.

PubMed

Bhandary, Sulatha; Khanna, Rajesh; Rao, Krishna A; Rao, Lavanya G; Lingam, Kamala D; Binu, V

2011-01-01

Corneal blindness accounts for 3.42% of blindness in Malaysia; the rate of eye donation is low. The aim of the study was to assess the awareness about eye donation and willingness to donate eyes among attendants of patients at various clinics in Melaka, Malaysia. This observational study was conducted on attendants who accompanied patients (n = 400) visiting various outpatient departments of the General Hospital and two peripheral clinics in Melaka between August and October 2007. The participants answered a questionnaire (Malay and English versions) which included demographic profile, awareness of eye donation, knowledge regarding facts of eye donation, and willingness to donate eyes. Univariate and multivariate logistic regression was performed at 5% level of significance. Awareness of eye donation was observed in 276 (69%) participants. Multivariate analysis showed that awareness was more among females when compared to males (P = 0.009). Of the 276 participants who were aware of eye donation, only 34.42% were willing to donate eyes. Willingness was more among the Indian race (P = 0.02) and males (P = 0.02). Educational status did not influence the willingness to donate eyes. Although majority of participants were aware of eye donation, willingness to donate eyes was poor.

REFINE (Reducing Falls in In-patient Elderly)--a randomised controlled trial.

PubMed

Vass, Catherine D; Sahota, Opinder; Drummond, Avril; Kendrick, Denise; Gladman, John; Sach, Tracey; Avis, Mark; Grainge, Matthew

2009-09-10

Falls in hospitals are common, resulting in injury and anxiety to patients, and large costs to NHS organisations. More than half of all in-patient falls in elderly people in acute care settings occur at the bedside, during transfers or whilst getting up to go to the toilet. In the majority of cases these falls are unwitnessed. There is insufficient evidence underpinning the effectiveness of interventions to guide clinical staff regarding the reduction of falls in the elderly inpatient. New patient monitoring technologies have the potential to offer advances in falls prevention. Bedside sensor equipment can alert staff, not in the immediate vicinity, to a potential problem and avert a fall. However no studies utilizing this assistive technology have demonstrated a significant reduction in falls rates in a randomised controlled trial setting. The research design is an individual patient randomised controlled trial of bedside chair and bed pressure sensors, incorporating a radio-paging alerting mode to alert staff to patients rising from their bed or chair, across five acute elderly care wards in Nottingham University Hospitals NHS Trust. Participants will be randomised to bedside chair and bed sensors or to usual care (without the use of sensors). The primary outcome is the number of bedside in-patient falls. The REFINE study is the first randomised controlled trial of bedside pressure sensors in elderly inpatients in an acute NHS Trust. We will assess whether falls can be successfully and cost effectively reduced using this technology, and report on its acceptability to both patients and staff.

Safety and efficacy of antibiotics compared with appendicectomy for treatment of uncomplicated acute appendicitis: meta-analysis of randomised controlled trials

PubMed Central

Varadhan, Krishna K; Neal, Keith R

2012-01-01

Objective To compare the safety and efficacy of antibiotic treatment versus appendicectomy for the primary treatment of uncomplicated acute appendicitis. Design Meta-analysis of randomised controlled trials. Population Randomised controlled trials of adult patients presenting with uncomplicated acute appendicitis, diagnosed by haematological and radiological investigations. Interventions Antibiotic treatment versus appendicectomy. Outcome measures The primary outcome measure was complications. The secondary outcome measures were efficacy of treatment, length of stay, and incidence of complicated appendicitis and readmissions. Results Four randomised controlled trials with a total of 900 patients (470 antibiotic treatment, 430 appendicectomy) met the inclusion criteria. Antibiotic treatment was associated with a 63% (277/438) success rate at one year. Meta-analysis of complications showed a relative risk reduction of 31% for antibiotic treatment compared with appendicectomy (risk ratio (Mantel-Haenszel, fixed) 0.69 (95% confidence interval 0.54 to 0.89); I2=0%; P=0.004). A secondary analysis, excluding the study with crossover of patients between the two interventions after randomisation, showed a significant relative risk reduction of 39% for antibiotic therapy (risk ratio 0.61 (0.40 to 0.92); I2=0%; P=0.02). Of the 65 (20%) patients who had appendicectomy after readmission, nine had perforated appendicitis and four had gangrenous appendicitis. No significant differences were seen for treatment efficacy, length of stay, or risk of developing complicated appendicitis. Conclusion Antibiotics are both effective and safe as primary treatment for patients with uncomplicated acute appendicitis. Initial antibiotic treatment merits consideration as a primary treatment option for early uncomplicated appendicitis. PMID:22491789

When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework

PubMed Central

Jull, J; Whitehead, M; Petticrew, M; Kristjansson, E; Gough, D; Petkovic, J; Volmink, J; Weijer, C; Taljaard, M; Edwards, S; Mbuagbaw, L; Cookson, R; McGowan, J; Lyddiatt, A; Boyer, Y; Cuervo, L G; Armstrong, R; White, H; Yoganathan, M; Pantoja, T; Shea, B; Pottie, K; Norheim, O; Baird, S; Robberstad, B; Sommerfelt, H; Asada, Y; Wells, G; Tugwell, P; Welch, V

2017-01-01

Background Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. Methods An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. Results A randomised trial can usefully be classified as ‘health equity relevant’ if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as ‘health equity relevant’ may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. Conclusion The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity. PMID:28951402

Impact Factors and Attitudes Toward Organ Donation Among Transplantation Patients and Their Caregivers in China.

PubMed

Zhang, Q-X; Xie, J-F; Zhou, J-D; Xiao, S-S; Liu, A-Z; Hu, G-Q; Chen, Y; Wang, C-Y

2017-11-01

This study's purpose was to investigate the attitudes toward organ donation among renal transplantation patients and their caregivers. In addition, we sought to explore the impact factors that affect their attitudes toward deceased organ donation. A self-administrated questionnaire was used, which consisted of two parts: 1) demographic data, and 2) transplantation and donation-related data. This study was conducted in three transplantation follow-up centers in three hospitals using a cross-sectional approach. SPSS 17.0 software was used to analysis descriptive and inferential statistics for data. The responses were analyzed using descriptive statistics and logistic regression analysis. We received 426 effective questionnaires. The renal transplantation patients' mean age was 40.84 years. Among these patients, 67.8% were willing to accept the organ transplantation surgery for their relatives, 67.4% were willing to donate a living kidney to a close relative, 62.7% were willing to donate organs after death, 53.5% were willing to register in the national organ donation system, and 51.4% were willing to sign the organ donation consent when facing their relatives becoming a potential organ donor. Age, marriage status, education level, understanding of transplantation procedures and understanding of donation procedures had statistical significance in the difference of the attitudes toward donate their organs after death (P < .05). Renal transplantation patients in our study are more willing to donate organs after death than their caregivers, but both their attitudes toward deceased donation were not very optimistic. There is a significant relationship between participants' willingness and knowledge of organ donation; patients with more understanding of the transplantation and donation procedure were more willing to donate organs after death. Affected by traditional values such as Confucianism, many people still cannot accept registering in the national organ donation system or sign the organ donation consent when facing their relatives becoming potential organ donors. There is a need to give adequate training regarding donation to increase donation rates. The government must provide education from the perspective of scientific knowledge to change the traditional views of the public, which may then increase the donation rate in China. Copyright © 2017 Elsevier Inc. All rights reserved.

Circumventing the “Ick” Factor: A Randomized Trial of the Effects of Omitting Affective Attitudes Questions to Increase Intention to Become an Organ Donor

PubMed Central

Doherty, Sally; Dolan, Elizabeth; Flynn, Jennifer; O’Carroll, Ronan E.; Doyle, Frank

2017-01-01

Objectives: Including or excluding certain questions about organ donation may influence peoples’ intention to donate. We investigated the effect of omitting certain affective attitudinal items on potential donors’ intention and behavior for donation. Design: A cross-sectional survey with a subgroup nested randomized trial. Methods: A total of 578 members of the public in four shopping centers were surveyed on their attitudes to organ donation. Non-donors (n = 349) were randomly assigned to one of three groups: Group 1 completed items on affective and cognitive attitudes, anticipated regret, intention, subjective norm and perceived behavioral control. Group 2 completed all items above but excluded affective attitudes. Group 3 completed all items but omitted negatively worded affective attitudes. The primary outcome was intention to donate, taking a donor card after the interview was a secondary behavioral outcome, and both were predicted using linear and logistic regression with group 1 as the reference. Results: Mean (SD) 1–7 intention scores for groups 1, 2 and 3 were, respectively: 4.43 (SD 1.89), 4.95 (SD 1.64) and 4.88 (SD 1.81), with group 2 significantly higher than group 1 (β = 0.518, 95% confidence interval [CI] 0.18 to 0.86).At the end of the interview, people in group 2 (66.7%; OR = 1.40, 95% CI 0.94 to 2.07, p = 0.096) but not those in group 3 (61.7%; OR = 1.10, 95% CI 0.69 to 1.75, p = 0.685), were marginally more likely to accept a donor card from the interviewer than people in group 1 (59.7%). Conclusion: Omitting affective attitudinal items results in higher intention to donate organs and marginally higher rates of acceptance of donor cards, which has important implications for future organ donation public health campaigns. PMID:28894429

A Trial of Financial and Social Incentives to Increase Older Adults' Walking.

PubMed

Harkins, Kristin A; Kullgren, Jeffrey T; Bellamy, Scarlett L; Karlawish, Jason; Glanz, Karen

2017-05-01

Despite evidence that regular physical activity confers health benefits, physical activity rates among older adults remain low. Both personal and social goals may enhance older adults' motivation to become active. This study tested the effects of financial incentives, donations to charity, and the combined effects of both interventions on older adults' uptake and retention of increased levels of walking. RCT comparing three interventions to control. Data collection occurred from 2012 to 2013. Analyses were conducted in 2013-2016. Ninety-four adults aged ≥65 years from Philadelphia-area retirement communities. All participants received digital pedometers, walking goals of a 50% increase in daily steps, and weekly feedback on goal attainment. Participants were randomized to one of four groups: (1) Control: received weekly feedback only; (2) Financial Incentives: received payment of $20 each week walking goals were met; (3) Social Goals: received donation of $20 to a charity of choice each week walking goals were met; and (4) Combined: received $20 each week walking goals were met that could be received by participant, donated to a charity of choice, or divided between the participant and charity. Mean proportion of days walking goals were met during the 16-week intervention and 4-week follow-up period. After adjusting for baseline walking, the proportion of days step goals were met during the 16-week intervention period was higher in all intervention groups versus controls (relative risk, 3.71; 95% CI=1.37, 10.01). During the 4-week follow up period, the proportion of days step goals were met did not differ in intervention groups compared to control (relative risk, 2.91; 95% CI=0.62, 13.64). Incentive schemes that use donations to a charity of choice, personal financial incentives, or a combination of the two can each increase older adults' initial uptake of increased levels of walking. This study is registered at www.clinicaltrials.gov NCT01643538. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Interventions to improve water quality and supply, sanitation and hygiene practices, and their effects on the nutritional status of children.

PubMed

Dangour, Alan D; Watson, Louise; Cumming, Oliver; Boisson, Sophie; Che, Yan; Velleman, Yael; Cavill, Sue; Allen, Elizabeth; Uauy, Ricardo

2013-08-01

Water, sanitation and hygiene (WASH) interventions are frequently implemented to reduce infectious diseases, and may be linked to improved nutrition outcomes in children. To evaluate the effect of interventions to improve water quality and supply (adequate quantity to maintain hygiene practices), provide adequate sanitation and promote handwashing with soap, on the nutritional status of children under the age of 18 years and to identify current research gaps. We searched 10 English-language (including MEDLINE and CENTRAL) and three Chinese-language databases for published studies in June 2012. We searched grey literature databases, conference proceedings and websites, reviewed reference lists and contacted experts and authors. Randomised (including cluster-randomised), quasi-randomised and non-randomised controlled trials, controlled cohort or cross-sectional studies and historically controlled studies, comparing WASH interventions among children aged under 18 years. Two review authors independently sought and extracted data on childhood anthropometry, biochemical measures of micronutrient status, and adherence, attrition and costs either from published reports or through contact with study investigators. We calculated mean difference (MD) with 95% confidence intervals (CI). We conducted study-level and individual-level meta-analyses to estimate pooled measures of effect for randomised controlled trials only. Fourteen studies (five cluster-randomised controlled trials and nine non-randomised studies with comparison groups) from 10 low- and middle-income countries including 22,241 children at baseline and nutrition outcome data for 9,469 children provided relevant information. Study duration ranged from 6 to 60 months and all studies included children under five years of age at the time of the intervention. Studies included WASH interventions either singly or in combination. Measures of child anthropometry were collected in all 14 studies, and nine studies reported at least one of the following anthropometric indices: weight-for-height, weight-for-age or height-for-age. None of the included studies were of high methodological quality as none of the studies masked the nature of the intervention from participants.Weight-for-age, weight-for-height and height-for-age z-scores were available for five cluster-randomised controlled trials with a duration of between 9 and 12 months. Meta-analysis including 4,627 children identified no evidence of an effect of WASH interventions on weight-for-age z-score (MD 0.05; 95% CI -0.01 to 0.12). Meta-analysis including 4,622 children identified no evidence of an effect of WASH interventions on weight-for-height z-score (MD 0.02; 95% CI -0.07 to 0.11). Meta-analysis including 4,627 children identified a borderline statistically significant effect of WASH interventions on height-for-age z-score (MD 0.08; 95% CI 0.00 to 0.16). These findings were supported by individual participant data analysis including information on 5,375 to 5,386 children from five cluster-randomised controlled trials.No study reported adverse events. Adherence to study interventions was reported in only two studies (both cluster-randomised controlled trials) and ranged from low (< 35%) to high (> 90%). Study attrition was reported in seven studies and ranged from 4% to 16.5%. Intervention cost was reported in one study in which the total cost of the WASH interventions was USD 15/inhabitant. None of the studies reported differential impacts relevant to equity issues such as gender, socioeconomic status and religion. The available evidence from meta-analysis of data from cluster-randomised controlled trials with an intervention period of 9-12 months is suggestive of a small benefit of WASH interventions (specifically solar disinfection of water, provision of soap, and improvement of water quality) on length growth in children under five years of age. The duration of the intervention studies was relatively short and none of the included studies is of high methodological quality. Very few studies provided information on intervention adherence, attrition and costs. There are several ongoing trials in low-income country settings that may provide robust evidence to inform these findings.

Exploring opinions and beliefs about cord blood donation among Hispanic and non-Hispanic black women.

PubMed

Rucinski, Dianne; Jones, Risé; Reyes, Brenda; Tidwell, Lawon; Phillips, RoiAnn; Delves, Denise

2010-05-01

Despite higher birth rates among non-Hispanic blacks and Hispanics, the availability of umbilical cord blood from these groups is lower due to lower donation rates than that of non-Hispanic whites. Similar racial and ethnic disparities in donation rates have been found for blood and organ donation. This study is among the first to explore beliefs and attitudes toward umbilical cord blood donation among Hispanic and non-Hispanic black women. Five focus groups composed of Hispanic and non-Hispanic black women were conducted to explore how women conceptualize information needs about umbilical cord blood donation and from whom women want to receive information about donation. Participants were adult women who had given birth within the past year or were pregnant. Lack of basic information regarding umbilical cord blood, its harvesting and use, and the steps and conditions necessary to donate were primary barriers to donation. Women expressed confusion over the differences between "donation" and "banking." The social value of donation was explicitly weighed in terms of the cost of the donation effort. Doctors were viewed as critical sources for information about donation, although women expressed skepticism about doctors' ability to convey sufficient information during short office visits. Efforts to increase donation rates among Hispanic and non-Hispanic black women should include information about both the technical aspects and the social value of donation. The specific terms "umbilical" and "donation" should be used consistently to prevent misunderstanding. Information should be provided by physicians with follow-up by other health providers.

Cognitive Behaviour Therapy versus a Counselling Intervention for Anxiety in Young People with High-Functioning Autism Spectrum Disorders: A Pilot Randomised Controlled Trial

ERIC Educational Resources Information Center

Murphy, Suzanne M.; Chowdhury, Uttom; White, Susan W.; Reynolds, Laura; Donald, Louisa; Gahan, Hilary; Iqbal, Zeinab; Kulkarni, Mahesh; Scrivener, Louise; Shaker-Naeeni, Hadi; Press, Dee A.

2017-01-01

The use of cognitive-behavioural therapy (CBT) as a treatment for children and adolescents with autism spectrum disorder (ASD) has been explored in a number of trials. Whilst CBT appears superior to no treatment or treatment as usual, few studies have assessed CBT against a control group receiving an alternative therapy. Our randomised controlled…

Pragmatic Pilot Cluster Randomised Control Trial of a School-Based Peer-Led Anti-Smoking Intervention for 13-14 Year Olds in Malaysia: Process Evaluation

ERIC Educational Resources Information Center

Melson, Elniee; Bridle, Christopher; Markham, Wolfgang

2017-01-01

Purpose: The purpose of this paper is to report the process evaluation of a pilot randomised control trial of an anti-smoking intervention for Malaysian 13-14-year olds, conducted in 2011/2012. It was hypothesised that trained peer supporters would promote non-smoking among classmates through informal conversations. Design/methodology/approach:…

Melatonin versus Placebo in Children with Autism Spectrum Conditions and Severe Sleep Problems Not Amenable to Behaviour Management Strategies: A Randomised Controlled Crossover Trial

ERIC Educational Resources Information Center

Wright, Barry; Sims, David; Smart, Siobhan; Alwazeer, Ahmed; Alderson-Day, Ben; Allgar, Victoria; Whitton, Clare; Tomlinson, Heather; Bennett, Sophie; Jardine, Jenni; McCaffrey, Nicola; Leyland, Charlotte; Jakeman, Christine; Miles, Jeremy

2011-01-01

Twenty-two children with autism spectrum disorders who had not responded to supported behaviour management strategies for severe dysomnias entered a double blind, randomised, controlled crossover trial involving 3 months of placebo versus 3 months of melatonin to a maximum dose of 10 mg. 17 children completed the study. There were no significant…

The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma.

PubMed

Woodcock, Ashley; Bakerly, Nawar Diar; New, John P; Gibson, J Martin; Wu, Wei; Vestbo, Jørgen; Leather, David

2015-12-10

Novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in real-world settings. The Salford Lung Study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of once-daily fluticasone furoate (100 μg or 200 μg)/vilanterol 25 μg in a novel dry-powder inhaler, versus existing asthma maintenance therapy. The study was initiated before this investigational treatment was licensed and conducted in real-world clinical practice to consider adherence, co-morbidities, polypharmacy, and real-world factors. Asthma Control Test at week 24; safety endpoints include the incidence of serious pneumonias. The study utilises the Salford electronic medical record, which allows near to real-time collection and monitoring of safety data. The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in asthma. Use of patients' linked electronic health records to collect clinical endpoints offers minimal disruption to patients and investigators, and also ensures patient safety. This highly innovative study will complement standard double-blind randomised controlled trials in order to improve our understanding of the risk/benefit profile of fluticasone furoate/vilanterol in patients with asthma in real-world settings. Clinicaltrials.gov, NCT01706198; 04 October 2012.

A randomised controlled trial evaluating the utility of a patient Decision Aid to improve clinical trial (RAVES 08.03) related decision-making.

PubMed

Sundaresan, Puma; Ager, Brittany; Turner, Sandra; Costa, Dan; Kneebone, Andrew; Pearse, Maria; Woo, Henry; Tesson, Stephanie; Juraskova, Ilona; Butow, Phyllis

2017-10-01

Randomised controlled trials (RCTs) are considered the 'gold-standard' for evaluating medical treatments. However, patients and clinicians report difficulties with informed consent and recruitment. We evaluated the utility of a Decision Aid (DA) in reducing RCT-related decisional conflict, and improving RCT knowledge and recruitment. Potential participants for a radiotherapy RCT were invited to participate in the current study. Participants were randomised to receive the RCT's participant information sheet with or without a DA. Questionnaires were administered at baseline, one and six months. The primary outcome measure was decisional conflict. Secondary outcome measures included knowledge regarding and recruitment to the RCT. 129 men were randomised to the DA (63) and control (66) arms. Decisional conflict was significantly lower over 6-months (p=0.048) in the DA arm. Knowledge regarding the RCT was significantly higher at 6months (p=0.033) in the DA arm. 20.6% of the DA arm (13 of 63) and 9% of the control arm (6 of 66) entered the RCT. This study demonstrates the utility of a DA in reducing decisional conflict and improving trial knowledge in men with cancer who are making decisions regarding RCT participation. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

41 CFR 102-37.35 - Who handles the donation of surplus property?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Who handles the donation...-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.35 Who handles the donation of surplus property? (a) The SASPs handle the donation of most surplus property to eligible donees...

41 CFR 102-37.45 - How long is property available for donation screening?

Code of Federal Regulations, 2010 CFR

2010-07-01

... available for donation screening? 102-37.45 Section 102-37.45 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.45 How long is property available for donation screening? Entities authorized to participate in the donation program may...

41 CFR 102-37.45 - How long is property available for donation screening?

Code of Federal Regulations, 2011 CFR

2011-01-01

... available for donation screening? 102-37.45 Section 102-37.45 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.45 How long is property available for donation screening? Entities authorized to participate in the donation program may...

41 CFR 102-37.45 - How long is property available for donation screening?

Code of Federal Regulations, 2013 CFR

2013-07-01

... available for donation screening? 102-37.45 Section 102-37.45 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.45 How long is property available for donation screening? Entities authorized to participate in the donation program may...

41 CFR 102-37.35 - Who handles the donation of surplus property?

Code of Federal Regulations, 2011 CFR

2011-01-01

... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false Who handles the donation...-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.35 Who handles the donation of surplus property? (a) The SASPs handle the donation of most surplus property to eligible donees...

41 CFR 102-37.35 - Who handles the donation of surplus property?

Code of Federal Regulations, 2012 CFR

2012-01-01

... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false Who handles the donation...-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.35 Who handles the donation of surplus property? (a) The SASPs handle the donation of most surplus property to eligible donees...

41 CFR 102-37.35 - Who handles the donation of surplus property?

Code of Federal Regulations, 2014 CFR

2014-01-01

... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false Who handles the donation...-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.35 Who handles the donation of surplus property? (a) The SASPs handle the donation of most surplus property to eligible donees...

41 CFR 102-37.35 - Who handles the donation of surplus property?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false Who handles the donation...-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.35 Who handles the donation of surplus property? (a) The SASPs handle the donation of most surplus property to eligible donees...

41 CFR 102-37.45 - How long is property available for donation screening?

Code of Federal Regulations, 2014 CFR

2014-01-01

... available for donation screening? 102-37.45 Section 102-37.45 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.45 How long is property available for donation screening? Entities authorized to participate in the donation program may...

41 CFR 102-37.45 - How long is property available for donation screening?

Code of Federal Regulations, 2012 CFR

2012-01-01

... available for donation screening? 102-37.45 Section 102-37.45 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY General Provisions Donation Overview § 102-37.45 How long is property available for donation screening? Entities authorized to participate in the donation program may...

Achievements and barriers in the organ donation process: a critical analysis of donation coordinators' discourse.

PubMed

Mercado-Martínez, Francisco J; Díaz-Medina, Blanca A; Hernández-Ibarra, Eduardo

2013-09-01

Donation coordinators play an important role in the success or failure of organ donation and transplant programs. Nevertheless, these professionals' perspectives and practices have hardly been explored, particularly in low- and middle-income countries. To examine donation coordinators' discourse on the organ donation process and the barriers they perceive. A critical qualitative study was carried out in Guadalajara, Mexico. Twelve donation coordinators from public and private hospitals participated. DATA GATHERING AND ANALYSIS: Data were gathered by using semistructured interviews and critical discourse analysis. Participants indicated that partial results have been achieved in deceased organ donation. Concomitantly, multiple obstacles have adversely affected the process and outcomes: at the structural level, the fragmentation of the health system and the scarcity of financial and material resources; at the relational level, nonegalitarian relationships between coordinators and hospital personnel; at the ideational level, the transplant domain and its specialists overshadow the donation domain and its coordinators. Negative images are associated with donation coordinators. Organ donation faces structural, relational, and ideational barriers; hence, complex interventions should be undertaken. Donation coordinators also should be recognized by the health system.

Clinical and cost effectiveness of mobile phone supported self monitoring of asthma: multicentre randomised controlled trial.

PubMed

Ryan, Dermot; Price, David; Musgrave, Stan D; Malhotra, Shweta; Lee, Amanda J; Ayansina, Dolapo; Sheikh, Aziz; Tarassenko, Lionel; Pagliari, Claudia; Pinnock, Hilary

2012-03-23

To determine whether mobile phone based monitoring improves asthma control compared with standard paper based monitoring strategies. Multicentre randomised controlled trial with cost effectiveness analysis. UK primary care. 288 adolescents and adults with poorly controlled asthma (asthma control questionnaire (ACQ) score ≥ 1.5) from 32 practices. Participants were centrally randomised to twice daily recording and mobile phone based transmission of symptoms, drug use, and peak flow with immediate feedback prompting action according to an agreed plan or paper based monitoring. Changes in scores on asthma control questionnaire and self efficacy (knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)) at six months after randomisation. Assessment of outcomes was blinded. Analysis was on an intention to treat basis. There was no significant difference in the change in asthma control or self efficacy between the two groups (ACQ: mean change 0.75 in mobile group v 0.73 in paper group, mean difference in change -0.02 (95% confidence interval -0.23 to 0.19); KASE-AQ score: mean change -4.4 v -2.4, mean difference 2.0 (-0.3 to 4.2)). The numbers of patients who had acute exacerbations, steroid courses, and unscheduled consultations were similar in both groups, with similar healthcare costs. Overall, the mobile phone service was more expensive because of the expenses of telemonitoring. Mobile technology does not improve asthma control or increase self efficacy compared with paper based monitoring when both groups received clinical care to guidelines standards. The mobile technology was not cost effective. Clinical Trials NCT00512837.

Analysis and interpretation of cost data in randomised controlled trials: review of published studies

PubMed Central

Barber, Julie A; Thompson, Simon G

1998-01-01

Objective To review critically the statistical methods used for health economic evaluations in randomised controlled trials where an estimate of cost is available for each patient in the study. Design Survey of published randomised trials including an economic evaluation with cost values suitable for statistical analysis; 45 such trials published in 1995 were identified from Medline. Main outcome measures The use of statistical methods for cost data was assessed in terms of the descriptive statistics reported, use of statistical inference, and whether the reported conclusions were justified. Results Although all 45 trials reviewed apparently had cost data for each patient, only 9 (20%) reported adequate measures of variability for these data and only 25 (56%) gave results of statistical tests or a measure of precision for the comparison of costs between the randomised groups. Only 16 (36%) of the articles gave conclusions which were justified on the basis of results presented in the paper. No paper reported sample size calculations for costs. Conclusions The analysis and interpretation of cost data from published trials reveal a lack of statistical awareness. Strong and potentially misleading conclusions about the relative costs of alternative therapies have often been reported in the absence of supporting statistical evidence. Improvements in the analysis and reporting of health economic assessments are urgently required. Health economic guidelines need to be revised to incorporate more detailed statistical advice. Key messagesHealth economic evaluations required for important healthcare policy decisions are often carried out in randomised controlled trialsA review of such published economic evaluations assessed whether statistical methods for cost outcomes have been appropriately used and interpretedFew publications presented adequate descriptive information for costs or performed appropriate statistical analysesIn at least two thirds of the papers, the main conclusions regarding costs were not justifiedThe analysis and reporting of health economic assessments within randomised controlled trials urgently need improving PMID:9794854

Hysteroscopic resection of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial.

PubMed

Vervoort, Ajmw; van der Voet, L F; Hehenkamp, Wjk; Thurkow, A L; van Kesteren, Pjm; Quartero, H; Kuchenbecker, W; Bongers, M; Geomini, P; de Vleeschouwer, Lhm; van Hooff, Mha; van Vliet, H; Veersema, S; Renes, W B; Oude Rengerink, K; Zwolsman, S E; Brölmann, Ham; Mol, Bwj; Huirne, Jaf

2018-02-01

To compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Multicentre randomised controlled trial. Eleven hospitals collaborating in a consortium for women's health research in the Netherlands. Women reporting postmenstrual spotting after a caesarean section who had a niche with a residual myometrium of ≥3 mm, measured during sonohysterography. Women were randomly allocated to hysteroscopic niche resection or expectant management for 6 months. The primary outcome was the number of days of postmenstrual spotting 6 months after randomisation. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, surgical parameters, quality of life, women's satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, except for niche measurements, also at 6 months after randomisation. We randomised 52 women to hysteroscopic niche resection and 51 women to expectant management. The median number of days of postmenstrual spotting at baseline was 8 days in both groups. At 6 months after randomisation, the median number of days of postmenstrual spotting was 4 days (interquartile range, IQR 2-7 days) in the intervention group and 7 days (IQR 3-10 days) in the control group (P = 0.04); on a scale of 0-10, discomfort as a result of spotting had a median score of 2 (IQR 0-7) in the intervention group, compared with 7 (IQR 0-8) in the control group (P = 0.02). In women with a niche with a residual myometrium of ≥3 mm, hysteroscopic niche resection reduced postmenstrual spotting and spotting-related discomfort. A hysteroscopic niche resection is an effective treatment to reduce niche-related spotting. © 2017 The Authors. BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

Effectiveness of mat Pilates or equipment-based Pilates in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial

PubMed Central

2013-01-01

Background Chronic low back pain is an expensive and difficult condition to treat. One of the interventions widely used by physiotherapists in the treatment of chronic non-specific low back pain is exercise therapy based upon the Pilates principles. Pilates exercises can be performed with or without specific equipment. These two types of Pilates exercises have never been compared on a high-quality randomised controlled trial. Methods/design This randomised controlled trial with a blinded assessor will evaluate eighty six patients of both genders with chronic low back pain, aged between 18 and 60 years, from one Brazilian private physiotherapy clinic. The patients will be randomly allocated into two groups: Mat Group will perform the exercises on the ground while the Equipment-based Group will perform the Pilates method exercises on the following equipment: Cadillac, Reformer, Ladder Barrel, and Step Chair. The general and specific disability of the patient, kinesiophobia, pain intensity and global perceived effect will be evaluated by a blinded assessor before randomisation and at six weeks and six months after randomisation. In addition, the expectation of the participants and their confidence with the treatment will be evaluated before randomisation and after the first treatment session, respectively. Discussion This will be the first study aiming to compare the effectiveness of Mat and Equipment-based Pilates exercises in patients with chronic non-specific low back pain. The results may help health-care professionals in clinical decision-making and could potentially reduce the treatment costs of this condition. Trial registration Brazilian Registry of Clinical Trials RBR-7tyg5j PMID:23298183

Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial

PubMed Central

Cui, Xiao-Ping; Lin, Min; Mu, Jun-Shan; Ye, Jian-Xin; He, Wen-Qing; Fu, Mao-Lin; Li, Hua; Fang, Jia-Yang; Shen, Feng-Feng; Lin, Hang

2016-01-01

Introduction Whether adding percutaneous transluminal angioplasty and stenting (PTAS) to background medical treatment is effective for decreasing the incidence of stroke or death in patients with symptomatic intracranial atherosclerosis (ICAS) is still controversial. We perform a randomised controlled trial to examine the effectiveness and safety of an improved PTAS procedure for patients with ICAS. Methods and analysis A randomised controlled trial will be conducted in three hospitals in China. Eligible patients with ICAS will be randomly assigned to receive medication treatment (MT) plus PTAS or MT alone. The MT will be initiated immediately after randomisation, while the PTAS will be performed when patients report relief of alarm symptoms defined as sudden weakness or numbness. All patients will be followed up at 30 days, 3 and 12 months after randomisation. The primary end point will be the incidence of stroke or death at 30 days after randomisation. Secondary outcomes will be the incidence of ischaemic stroke in the territory of stenosis arteries, the incidence of in-stent restenosis, the Chinese version of the modified Rankin Scale and the Chinese version of the Stroke-Specific Quality of Life (CSQoL). Ethics and dissemination The study protocol is approved by institutional review boards in participating hospitals (reference number FZ20160003, 180PLA20160101 and 476PLA2016007). The results of this study will be disseminated to patients, physicians and policymakers through publication in a peer-reviewed journal or presentations in conferences. It is anticipated that the results of this study will improve the quality of the current PTAS procedure and guide clinical decision-making for patients with ICAS. Trial registration number NCT02689037 PMID:27852711

Blood Donation Process

MedlinePlus

... to donate. All medical equipment used for this test, as well as during the donation process, is sterile, used only once and then disposed. Blood Donation Once the pre-donation screening is finished, you will proceed to ...

A cost-effectiveness comparison of embryo donation with oocyte donation.

PubMed

Finger, Reginald; Sommerfelt, Carol; Freeman, Melanie; Wilson, Carrie K; Wade, Amy; Daly, Douglas

2010-02-01

To compare the cost-effectiveness of embryo donation (ED) to that of oocyte donation (OD). Calculation of cost-effectiveness ratios (costs per outcome achieved) using data derived from clinical practices. In vitro fertilization centers and embryo donation programs. Infertile couples undergoing oocyte donation or embryo donation. Oocyte donation or embryo donation cycles. Cost-effectiveness ratios. For a single cycle, ED is approximately twice as cost-effective as OD, with a cost-effectiveness ratio of $21,990 per live delivery compared to 40,600 dollars. When strategies of up to three cycles (to achieve one live delivery) are used, ED costs 13,505 dollars per live delivery compared to 31,349 dollars for OD. Cost-effectiveness is a compelling reason for infertile couples to consider embryo donation. Copyright 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Effects of phased education on attitudes toward organ donation and willingness to donate after brain death in an Asian country.

PubMed

Park, Ui Jun; Han, Sang Youb; Han, Kum Hyun; Oh, Se Won; Jang, Hye-Yeon; Kim, Hyoung Tae; Roh, Young-Nam

2018-05-23

This study aims to investigate the effects of phased education on attitudes toward organ donation and willingness to donate after brain death. A survey was conducted using a questionnaire to examine attitudes toward organ donation of the families of patients admitted to a surgical intensive care unit (SICU) between March 1, 2014 and September 30, 2016. Ninety-two people voluntarily participated in this survey. Before reviewing the educational material, 75.0% had a positive attitude toward organ donation, 60.9% were willing to donate their own organs, and 38.0% were willing to donate a family member's organs. After reviewing the educational material, these figures increased to 92.4%, 80.4%, and 56.5%, respectively. Before receiving an education, there was a significant difference in consistency between people's attitudes and willingness to donate their own organs, versus donating a family member's organs (79.3% vs 54.3%, p < 0.001). With phased education, these percentages increased from 79.3% to 85.9% with regard to donating one's own organs, and from 54.3% to 64.1% with regard to donating a family member's organs. Phased education was effective overall, but it had a limited effect on changing the willingness to donate a family member's organs. It increased the consistency between people's attitudes toward organ donation and willingness to donate their own, or a family member's organs. Copyright © 2018. Published by Elsevier Taiwan.

Body donation in India: social awareness, willingness, and associated factors.

PubMed

Rokade, Shrikant A; Gaikawad, Anjana P

2012-01-01

With the attendant rise of the number of medical colleges in India over past few decades, the demand for cadavers used in medical education and research is growing. However, there is an insufficient supply of donated cadavers available for dissection. This study was undertaken to assess the general population's awareness of body donation programs and willingness to donate in the State of Maharashtra, India. The willingness of participants to donate was compared with age, gender, and education of the respondents. A total of 625 adult individuals from the State of Maharashtra participated in a survey composed of questions about age, sex, education, awareness of body donation programs, and willingness to donate. It was found that 90.9% of the medical colleges surveyed reported an inadequate supply of cadavers. Of the general population, 32.1% of respondents were aware of body donation, compared to 95.83% of health care professionals. However, only 19.5% of the general population and 44.9% of health care professionals were willing to donate their bodies for anatomical education. Younger age groups, males, graduates, and postgraduates were found more willing to donate their bodies. Organ donation was preferred over body donation. A lack of awareness about body donation was the main factor responsible for respondents' "no body donation" response in the general population, along with firm religious beliefs and customs, the fear that the donated body will not be treated with respect and dignity, and the unacceptability of the dissection of one's own body. To overcome the current shortage of donated cadavers, efforts should be undertaken to change the mindset of the wider Indian society toward body donation. The authors believe this is possible through awareness campaigns and that prospective donors' concerns should be addressed appropriately. Proper guidance and assistance regarding body donation should be easily available for potential donors. Copyright © 2012 American Association of Anatomists.

Pediatric Donation After Circulatory Determination of Death: A Scoping Review.

PubMed

Weiss, Matthew J; Hornby, Laura; Witteman, William; Shemie, Sam D

2016-03-01

Although pediatric donation after circulatory determination of death is increasing in frequency, there are no national or international donation after circulatory determination of death guidelines specific to pediatrics. This scoping review was performed to map the pediatric donation after circulatory determination of death literature, identify pediatric donation after circulatory determination of death knowledge gaps, and inform the development of national or regional pediatric donation after circulatory determination of death guidelines. Terms related to pediatric donation after circulatory determination of death were searched in Embase and MEDLINE, as well as the non-MEDLINE sources in PubMed from 1980 to May 2014. Seven thousand five hundred ninety-seven references were discovered and 85 retained for analysis. All references addressing pediatric donation after circulatory determination of death were considered. Exclusion criteria were articles that did not address pediatric patients, animal or laboratory studies, surgical techniques, and local pediatric donation after circulatory determination of death protocols. Narrative reviews and opinion articles were the most frequently discovered reference (25/85) and the few discovered studies were observational or qualitative and almost exclusively retrospective. Retained references were divided into themes and analyzed using qualitative methodology. The main discovered themes were 1) studies estimating the number of potential pediatric donation after circulatory determination of death donors and their impact on donation; 2) ethical issues in pediatric donation after circulatory determination of death; 3) physiology of the dying process after withdrawal of life-sustaining therapy; 4) cardiac pediatric donation after circulatory determination of death; and 5) neonatal pediatric donation after circulatory determination of death. Donor estimates suggest that pediatric donation after circulatory determination of death will remain an event less common than brain death, albeit with the potential to substantially expand the existing organ donation pool. Limited data suggest outcomes comparable with organs donated after neurologic determination of death. Although there is continued debate around ethical aspects of pediatric donation after circulatory determination of death, all pediatric donation after circulatory determination of death publications from professional societies contend that pediatric donation after circulatory determination of death can be practiced ethically. This review provides a comprehensive overview of the published literature related to pediatric donation after circulatory determination of death. In addition to informing the development of pediatric-specific guidelines, this review serves to highlight several important knowledge gaps in this topic.

"Why throw away something useful?": Attitudes and opinions of people treated for bipolar disorder and their relatives on organ and tissue donation.

PubMed

Padoan, Carolina S; Garcia, Lucas F; Rodrigues, Aline A; Patusco, Lucas M; Atz, Mariana V; Kapczinski, Flavio; Goldim, José R; Magalhães, Pedro V S

2017-03-01

In regard to mental illness, brain donation is essential for the biological investigation of central pathology. Nevertheless, little is known about the thoughts of people with mental disorders on tissue donation for research. Here, our objective was to understand the attitudes and opinions of people treated for bipolar disorder and their relatives regarding donation in general, and particularly donation for research. This is a qualitative study that used in-depth interviews to determine the thoughts of participants regarding tissue donation for research. Theoretical sampling was used as a recruitment method. Grounded theory was used as a framework for content analyses of the interviews. A semi-structured interview guide was applied with the topics: donation in general; donation for research; mental health and body organs; opinion regarding donation; feelings aroused by the topic. Although all participants were aware of organ donation for transplant, they were surprised that tissue could be donated for research. Nevertheless, once they understood the concept they were usually in favor of the idea. Although participants demonstrated a general lack of knowledge on donation for research, they were willing to learn more and viewed it as a good thing, with altruistic reasons often cited as a motive for donation. We speculate that bridging this knowledge gap may be a fundamental step towards a more ethical postmortem tissue donation process.

41 CFR 102-37.520 - What is the authority for public airport donations?

Code of Federal Regulations, 2010 CFR

2010-07-01

... for public airport donations? 102-37.520 Section 102-37.520 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY Donations to Public Airports § 102-37.520 What is the authority for public airport donations? The authority for public airport donations is 49 U.S.C. 47151. 49 U...

41 CFR 102-37.520 - What is the authority for public airport donations?

Code of Federal Regulations, 2012 CFR

2012-01-01

... for public airport donations? 102-37.520 Section 102-37.520 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY Donations to Public Airports § 102-37.520 What is the authority for public airport donations? The authority for public airport donations is 49 U.S.C. 47151. 49 U...

41 CFR 102-37.520 - What is the authority for public airport donations?

Code of Federal Regulations, 2013 CFR

2013-07-01

... for public airport donations? 102-37.520 Section 102-37.520 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY Donations to Public Airports § 102-37.520 What is the authority for public airport donations? The authority for public airport donations is 49 U.S.C. 47151. 49 U...

41 CFR 102-37.520 - What is the authority for public airport donations?

Code of Federal Regulations, 2014 CFR

2014-01-01

... for public airport donations? 102-37.520 Section 102-37.520 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY Donations to Public Airports § 102-37.520 What is the authority for public airport donations? The authority for public airport donations is 49 U.S.C. 47151. 49 U...

41 CFR 102-37.520 - What is the authority for public airport donations?

Code of Federal Regulations, 2011 CFR

2011-01-01

... for public airport donations? 102-37.520 Section 102-37.520 Public Contracts and Property Management... 37-DONATION OF SURPLUS PERSONAL PROPERTY Donations to Public Airports § 102-37.520 What is the authority for public airport donations? The authority for public airport donations is 49 U.S.C. 47151. 49 U...

Right hepatic lobe donation adversely affects donor life insurability up to one year after donation.

PubMed

Nissing, Matthew H; Hayashi, Paul H

2005-07-01

There are no data regarding hepatic lobe donation effects on donor life insurability. Two investigators called 10 agents of 10 different large life insurance companies. One investigator gave a fictitious profile: Caucasian man, 33 years old, nonsmoker, without medical problems (control profile [CP]). The other investigator used the same profile with a history of uncomplicated right lobe donation 12 months earlier (donor profile [DP]). Investigators asked for premium quotes on a $100,000 term life policy. No medical testing or record review was allowed. Investigators were blinded to the results of each other's calls. Agents were unaware of the study. We documented underwriting decisions, premiums quoted, stipulations, number of phone calls, and phone time. All 10 companies would pursue underwriting CP at their lowest, "preferred" rate. Five would do the same for DP. Two might underwrite DP at a more expensive "standard" rate, but a "preferred" rate would be less likely. One would underwrite DP at the "standard" rate; one would not underwrite DP. One agent did not return follow-up calls (DP insurability < CP, P = 0.04). Mean quoted premiums were lower for CP vs. DP ($189/yr. vs. $202/yr., P = 0.56). Median number of phone calls required was 1 for CP and 3 for DP (P = 0.01). Mean telephone minutes were 4.2 for CP and 8.0 for DP (P = 0.004). In conclusion, right hepatic lobe donation decreases life insurability 1 year after uncomplicated donation. Donors can expect some increased difficulty obtaining life insurance, but they should find a company willing to pursue underwriting. The premium paid may be slightly higher.

Whole Blood Donation Affects the Interpretation of Hemoglobin A1c

PubMed Central

Lenters-Westra, Erna; de Kort, Wim; Bokhorst, Arlinke G.; Bilo, Henk J. G.; Slingerland, Robbert J.; Vos, Michel J.

2017-01-01

Introduction Several factors, including changed dynamics of erythrocyte formation and degradation, can influence the degree of hemoglobin A1c (HbA1c) formation thereby affecting its use in monitoring diabetes. This study determines the influence of whole blood donation on HbA1c in both non-diabetic blood donors and blood donors with type 2 diabetes. Methods In this observational study, 23 non-diabetic blood donors and 21 blood donors with type 2 diabetes donated 475 mL whole blood and were followed prospectively for nine weeks. Each week blood samples were collected and analyzed for changes in HbA1c using three secondary reference measurement procedures. Results Twelve non-diabetic blood donors (52.2%) and 10 (58.8%) blood donors with type 2 diabetes had a significant reduction in HbA1c following blood donation (reduction >-4.28%, P < 0.05). All non-diabetic blood donors with a normal ferritin concentration predonation had a significant reduction in HbA1c. In the non-diabetic group the maximum reduction was -11.9%, in the type 2 diabetes group -12.0%. When eligible to donate again, 52.2% of the non-diabetic blood donors and 41.2% of the blood donors with type 2 diabetes had HbA1c concentrations significantly lower compared to their predonation concentration (reduction >-4.28%, P < 0.05). Conclusion Patients with type 2 diabetes contributing to whole blood donation programs can be at risk of falsely lowered HbA1c. This could lead to a wrong interpretation of their glycemic control by their general practitioner or internist. PMID:28118412

[Efficiency indicators to assess the organ donation and transplantation process: systematic review of the literature].

PubMed

Siqueira, Marina Martins; Araujo, Claudia Affonso; de Aguiar Roza, Bartira; Schirmer, Janine

2016-08-01

To search the literature and identify indicators used to monitor and control the organ donation and transplantation process and to group these indicators into categories. In November 2014, a systematic review of the literature was carried out in the following databases: Biblioteca Virtual em Saúde (BVS), EBSCO, Emerald, Proquest, Science Direct, and Web of Science. The following search terms (and the corresponding terms in Brazilian Portuguese) were employed: "efficiency," "indicators," "organ donation," "tissue and organ procurement," and "organ transplantation." Of the 344 articles retrieved, 23 original articles published between 1992 and 2013 were selected and reviewed for analysis of efficiency indicators. The review revealed 117 efficiency indicators, which were grouped according to similarity of content and divided into three categories: 1) 71 indicators related to organ donation, covering mortality statistics, communication of brain death, clinical status of donors and exclusion of donors for medical reasons, attitude of families, confirmation of donations, and extraction of organs and tissues; 2) 22 indicators related to organ transplantation, covering the surgical procedure per se and post-transplantation follow-up; and 3) 24 indicators related to the demand for organs and the resources of hospitals involved in the process. Even if organ transplantation is a recent phenomenon, the high number of efficiency indicators described in the literature suggests that scholars interested in this field have been searching for ways to measure performance. However, there is little standardization of the indicators used. Also, most indicators focus on the donation step, suggesting gaps in the measurement of efficiency at others points in the process. Additional indicators are needed to monitor important stages, such as organ distribution (for example, organ loss indicators) and post-transplantation aspects (for example, survival and quality of life).

Assessment of the knowledge of living unrelated donors of the complications of kidney donation in Iran.

PubMed

Ossareh, Shahrzad; Karbasi, Arsha

2009-12-01

Living unrelated donors (LURDs) constitute the major source of renal allograft in Iran. LURD transplantation (Tx) is performed in a controlled program, supervised by university Tx teams, and assisted by the Dialysis and Transplant Patient's Association (DATPA). This study evaluated the knowledge of donors about possible short- and long-term complications of kidney donation and the need for regular follow-up. We interviewed 100 consecutive living donors/donation candidates (all called donors), 35 in the postoperative period in the renal Tx ward, and 65 after completion of preoperative assessment in the office of the DATPA, to assess their knowledge about complications of nephrectomy and their intention to participate in the postoperative follow-up. Seventy-nine donors were men and 21 women. Mean age was 27 +/- 4.4 years. Ninety-seven donors were unrelated to the recipient and three were related (LRD). The motivation for donation was altruistic in nine (three LRD and six LURD) and financial in 89. Eighty donors were not aware of the possible short- or long-term complications of nephrectomy. Six donors mentioned the possibility of potential intraoperative complications, and 16 mentioned the risk of renal failure. Only 44 donors knew that they should visit doctors regularly after donation, most of them (61%) from the postoperative group. We conclude that most donors do not have enough knowledge about possible in-hospital and long-term complications of kidney donation and may not participate in regular follow-up after operation. Considering the young age of our renal Tx donors, we suggest that they should receive more preoperative orientation (both verbal and written) about possible complications and the need for regular postoperative medical follow-up.

The Effect of Standardized Interviews on Organ Donation.

PubMed

Corman Dincer, Pelin; Birtan, Deniz; Arslantas, Mustafa Kemal; Tore Altun, Gulbin; Ayanoglu, Hilmi Omer

2018-03-01

Organ donation is the most important stage for organ transplant. Studies reveal that attitudes of families of brain-dead patients toward donation play a significant role in their decision. We hypothesized that supporting family awareness about the meaning of organ donation, including saving lives while losing a loved one, combined with being informed about brain death and the donation process must be maintained by intensive care unit physicians through standardized interviews and questionnaires to increase the donation rate. We retrospectively evaluated the final decisions of families of 52 brain-dead donors treated at our institution between 2014 and 2017. Data underwent descriptive analyses. The standard interview content was generated after literature search results were reviewed by the authors. Previously, we examined the impact of standardized interviews done by intensive care unit physicians with relatives of potential brain-dead donors regarding decisions to donate or reasons for refusing organ donation. After termination of that study, interviews were done according to the intensivist's orientation, resulting in significantly decreased donation rates. Standardized interviews were then started again, resulting in increased donation rates. Of 17 families who participated in standardized interviews, 5 families (29.4%) agreed to donate organs of their brain-dead relatives. In the other group of families, intensivists governed informing the families of donation without standardized interviews. In this group of 35 families, 5 families (14.3%) approved organ donation. The decision regarding whether to agree to organ donation was statistically different between the 2 family groups (P < .05). Conducting a standard interview between relatives of brain-dead donors and the intensivists, facilitating visits between relatives and the brain-dead patients, and informing relatives about the donation process resulted in an increased rate of organ donation compared with routine protocols.

Eye donation – Awareness and willingness among attendants of patients at various clinics in Melaka, Malaysia

PubMed Central

Bhandary, Sulatha; Khanna, Rajesh; Rao, Krishna A; Rao, Lavanya G; Lingam, Kamala D; Binu, V

2011-01-01

Aim: Corneal blindness accounts for 3.42% of blindness in Malaysia; the rate of eye donation is low. The aim of the study was to assess the awareness about eye donation and willingness to donate eyes among attendants of patients at various clinics in Melaka, Malaysia. Materials and Methods: This observational study was conducted on attendants who accompanied patients (n = 400) visiting various outpatient departments of the General Hospital and two peripheral clinics in Melaka between August and October 2007. The participants answered a questionnaire (Malay and English versions) which included demographic profile, awareness of eye donation, knowledge regarding facts of eye donation, and willingness to donate eyes. Univariate and multivariate logistic regression was performed at 5% level of significance. Results: Awareness of eye donation was observed in 276 (69%) participants. Multivariate analysis showed that awareness was more among females when compared to males (P = 0.009). Of the 276 participants who were aware of eye donation, only 34.42% were willing to donate eyes. Willingness was more among the Indian race (P = 0.02) and males (P = 0.02). Educational status did not influence the willingness to donate eyes. Conclusions: Although majority of participants were aware of eye donation, willingness to donate eyes was poor. PMID:21157071

Indexing of randomised controlled trials of physiotherapy interventions: a comparison of AMED, CENTRAL, CINAHL, EMBASE, hooked on evidence, PEDro, PsycINFO and PubMed.

PubMed

Moseley, Anne M; Sherrington, Catherine; Elkins, Mark R; Herbert, Robert D; Maher, Christopher G

2009-09-01

To compare the comprehensiveness of indexing the reports of randomised controlled trials of physiotherapy interventions by eight bibliographic databases (AMED, CENTRAL, CINAHL, EMBASE, Hooked on Evidence, PEDro, PsycINFO and PubMed). Audit of bibliographic databases. Two hundred and eighty-one reports of randomised controlled trials of physiotherapy interventions were identified by screening the reference lists of 30 relevant systematic reviews published in four consecutive issues of the Cochrane Database of Systematic Reviews (Issue 3, 2007 to Issue 2, 2008). AMED, CENTRAL, CINAHL, EMBASE, Hooked on Evidence, PEDro, PsycINFO and PubMed were used to search for the trial reports. The number of trial reports indexed in each database was calculated. PEDro indexed 99% of the trial reports, CENTRAL indexed 98%, PubMed indexed 91%, EMBASE indexed 82%, CINAHL indexed 61%, Hooked on Evidence indexed 40%, AMED indexed 36% and PsycINFO indexed 17%. Most trial reports (92%) were indexed on four or more of the databases. One trial report was indexed on a single database (PEDro). Of the eight bibliographic databases examined, PEDro and CENTRAL provide the most comprehensive indexing of reports of randomised trials of physiotherapy interventions.

An analysis of knowledge and attitudes of hospice staff towards organ and tissue donation.

PubMed

Wale, J; Arthur, A; Faull, C

2014-03-01

Only a minority of hospice patients eligible to donate tissue and organs choose to do so. Hospice care staff play a key role in discussions about donation, but their willingness to engage in these discussions and their understanding of issues around tissue and organ donation is poorly understood. To (i) identify factors associated with the wish of hospice doctors, nurses and healthcare assistants to donate their own organs after death; (ii) survey the experience of discussing the subject with patients; (iii) determine staff members' knowledge of organ and tissue donation and (iv) identify factors associated with knowledge of organ and tissue donation. Cross-sectional questionnaire survey of hospice care staff. 76 of the 94 care staff of one large UK hospice completed and returned the questionnaire. Staff wishing to donate their organs after death (43/76 56.6%) were more likely to be doctors or nurses than healthcare assistants (p=0.011) and more likely to have discussed organ or tissue donation with their family (p<0.001). Staff reporting ever having discussed donation with patients had more years' experience (p=0.045) and had similarly discussed donation with their own family (p=0.039). Those with greater knowledge were more likely to have discussed organ or tissue donation with a patient (p=0.042). A reluctance to instigate discussions about organ and tissue donation may prevent palliative patients and their families being allowed the opportunity to donate. Suboptimal knowledge among hospice staff suggests the need for greater liaison between hospice staff, and the organ and tissue donation teams.

First-time whole blood donation: A critical step for donor safety and retention on first three donations.

PubMed

Gillet, P; Rapaille, A; Benoît, A; Ceinos, M; Bertrand, O; de Bouyalsky, I; Govaerts, B; Lambermont, M

2015-01-01

Whole blood donation is generally safe although vasovagal reactions can occur (approximately 1%). Risk factors are well known and prevention measures are shown as efficient. This study evaluates the impact of the donor's retention in relation to the occurrence of vasovagal reaction for the first three blood donations. Our study of data collected over three years evaluated the impact of classical risk factors and provided a model including the best combination of covariates predicting VVR. The impact of a reaction at first donation on return rate and complication until the third donation was evaluated. Our data (523,471 donations) confirmed the classical risk factors (gender, age, donor status and relative blood volume). After stepwise variable selection, donor status, relative blood volume and their interaction were the only remaining covariates in the model. Of 33,279 first-time donors monitored over a period of at least 15 months, the first three donations were followed. Data emphasised the impact of complication at first donation. The return rate for a second donation was reduced and the risk of vasovagal reaction was increased at least until the third donation. First-time donation is a crucial step in the donors' career. Donors who experienced a reaction at their first donation have a lower return rate for a second donation and a higher risk of vasovagal reaction at least until the third donation. Prevention measures have to be processed to improve donor retention and provide blood banks with adequate blood supply. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Voluntary Blood Donation among Students - A Cross-Sectional Study on Knowledge and Practice vs. Attitude

PubMed Central

Pehlajani, Nand K.; Sinha, Mithilesh K.

2016-01-01

Introduction The factors influencing blood donation decisions are varied and complex and one’s attitude can influence this decision. Aim To find the factors affecting the knowledge and practice of blood donation among college students and their attitude towards the same. Materials and Methods This cross-sectional study was conducted among 399 college going students using convenience sampling from medical, nursing and engineering colleges in Bhubaneswar city, where blood donation camps were to be held. Data was collected through self-administered questionnaires and, analysed in SPSS Version 20.0. Results Knowledge regarding blood donation was adequate among 228 (57.1%) of the students and, 221 (55.4%) students had donated blood. Knowledge was significantly better among female students, medical stream and in those whose parents were in non-medical jobs; whereas blood donation had been done significantly more by male, non-medical stream students and by those whose parents were in medical field. Most common reason for donating blood was a sense of social responsibility and most common reason of non-donation was fear of the procedure. An 85% of the students were of the view that they would donate blood if asked. Students suggested that small incentives like certificates and arranging transport for blood donation would make it easier to donate. Conclusion Just over half of the students had adequate knowledge about blood donation and similar percentage had donated blood. There is this large pool of safe blood in college going students who are willing, but not tapped as source of blood donation. PMID:27891345

Analysis of Chinese Donors’ Return Behavior

PubMed Central

Guo, Nan; Wang, Jingxing; Ness, Paul; Yao, Fuzhu; Dong, Xiangdong; Bi, Xinhong; Mei, Heili; Li, Julin; He, Weilan; Lu, Yunlai; Ma, Hongli; Wen, Xiuqiong; Huang, Mei; Wright, David J.; King, Melissa; High, Patrick; Nelson, Kenrad; Shan, Hua

2010-01-01

Background It is important to understand donor return behavior. Converting first time donors to become repeat donors is essential for maintaining an adequate blood supply. Methods Characteristics of 241,552 whole blood (WB) donations from first time (FT) and repeat (RPT) donors who donated in 2008 at the 5 blood centers in China were compared. A subset of 54,394 WB donors who donated between January 1 and March 31, 2008 were analyzed for their return behavior in 2008 following the index donation using logistic regression. Results Of all donations, 64% was from FT donors. Donors with self-reported previous donations tended to be male, older, married, donated larger volume (≥300mL), and were heavier in weight. Among donors who donated from January to March, 2008, 14% returned for subsequent WB donations by the end of 2008. The number of previous donations and blood collection location were the two strongest predictors for making subsequent donations. Donors with 1, 2–3 and more than 3 previous donations were 3.7, 5.7, and 11.0 times more likely to return than FT donors. Those who donated in a blood collection vehicle were 4 times more likely to return than those who donated at a blood center. Being female, younger and of a lower education level (≤ middle school) were positively associated with subsequent return blood donation during the follow-up period observed in this study. Conclusion Most of the Chinese blood supply is from first time donors. Strategies aimed at encouraging current donors to become repeat donors are needed. PMID:20849408

The interpersonal process in tissue donation requests with “undecided” next of kin

PubMed Central

Dorflinger, Lindsey; Auerbach, Stephen M.; Siminoff, Laura A.

2012-01-01

Context Although recent studies have demonstrated that tissue requesters’ behavior during conversations about tissue donation affects consent rates, the link between requesters’ behavior and consent rates remains unclear. Objective To examine whether positive/collaborative requester behaviors elicit complementary behaviors from next of kin who were initially undecided about their willingness to donate their deceased family member’s tissues. Design Audio recordings of requests were coded to assess for interpersonal behavior of each interactant. Setting Audio recordings were gathered from a national sample of tissue banks. Participants One hundred and two requester–next-of-kin dyads, consisting of 102 relatives and 53 requesters. Main Outcome Measures Tissue requester and next-of-kin affiliation and interpersonal control were assessed. Tissue requesters’ persuasion, confirmation (eg, approval, empathy, reassurance) and disapproval, as well as next-of-kin approval and disapproval, were examined. Results Tissue requesters and next of kin tended to match one another on affiliation and complement one another on interpersonal control. “Key topics,” which may affect the next of kin’s decision, are discussed in only about one-third of requests. Next of kin were less affiliative and more disapproving when requesters were also more disapproving. Interpersonal behavior of the tissue requester, such as affiliation, statements of disapproval, and persuasion, as well as discussion of key topics, was a significant predictor of the interpersonal behavior of the next of kin. Conclusions Positive requester behaviors elicited a positive response from undecided next of kin. Because many next of kin have limited knowledge about tissue donation before the request, the communication process may affect the next of kin’s perceptions of donation and thus affect the likelihood of consent. Findings could potentially inform communication skills training for tissue requesters; future research could examine effects of such training on consent rates. PMID:23187062

Awareness and attitudes towards organ donation among medical students at King Abdulaziz University, Jeddah, Saudi Arabia.

PubMed

Sayedalamin, Zaid; Imran, Muhammad; Almutairi, Osama; Lamfon, Mohammed; Alnawwar, Majd; Baig, Mukhtiar

2017-04-01

To assess awareness and attitude of medical students about organ donation. This cross-sectional study was conducted in 2014 at King Abdulaziz University, Jeddah, Saudi Arabia, and comprised medical students. The participants were asked about their religious and other beliefs towards organ donation, their reasons for not donating organs, and their personal opinions about organ donation through a questionnaire. SPSS 21 was used for data analysis. Of the 481 participants, 250(52%) were females, and 231(48%) were males. The overall mean age was 21.36±1.63 years. Besides, 437(90.9%) students knew what organ donation means, 433(90%) supported organ donation, and 90(18.7%) knew someone who had donated an organ. Moreover, 245(50.9%) participants were willing to donate their organ to their family alone, 198(41.2%) were willing to donate to any deserving patient while 439(91.3%) rejected that religion precluded organ donation, and 354(73.6%) did not know about the grafting of organs from a man to a woman and vice versa. Awareness and attitude towards organ donation were not up to the mark among the participants.

Living donation decision making: recipients' concerns and educational needs.

PubMed

Waterman, Amy D; Stanley, Sara L; Covelli, Tonie; Hazel, Erik; Hong, Barry A; Brennan, Daniel C

2006-03-01

Despite the advantages of living donor transplantation, evidence suggests that some potential recipients with living donors have psychological concerns that prevent them from pursuing living donation. Addressing these concerns through education may increase the rates of living donation. To understand the psychological barriers and educational needs of potential kidney recipients regarding living donation. Qualitative focus group study of kidney transplant recipients, donors, and family members to explore their assessment of the advantages of dialysis and deceased donor transplantation over living donation, their concerns about living donation, and what types of living donation education would be most helpful. Kidney recipients reported that they might not pursue living donation because they felt guilty and indebted to the donor, did not want to harm or inconvenience the donor, did not want to accept a kidney that a family member might need later, and did not want to disappoint the donor if the kidney failed. Recipients were generally unaware that donors could personally benefit from donating and would rather wait for donor volunteers than ask anyone directly. Both donors and recipients thought that training on how to make the donation request and education about living donors' motivations for donation and transplant experience could help more renal patients pursue living donation.

Are Older Adults More Willing to Donate? The Roles of Donation Form and Social Relationship.

PubMed

Gong, Xianmin; Zhang, Fan; Fung, Helene H

2017-07-21

Whether older adults are more prosocial than younger adults has been under debate. In the current study, we investigated how age differences in prosocial behaviors varied across different contextual factors, that is, donation form, kinship, and social distance. To achieve this purpose, 89 younger and 66 older adults took part in a hypothetical donation task in which they were asked to donate money and time to relatives and nonrelatives at various social distances. The results showed that, compared to younger adults, (a) older adults donated less to nonrelatives (regardless of the donation form), but donated a similar amount (in money) or even donated more (in time) to relatives; (b) older adults displayed higher levels of kin selection (favoring relatives over nonrelatives) in both monetary and time donations; and (c) older adults showed higher levels of social discounting (favoring socially close over distant others) in monetary but not time donation. The study underscored the importance of contextual factors in understanding age differences in prosocial behaviors such as donation. © The Author 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Attitudes toward organ donation among personnel from the University Hospital of Rabat.

PubMed

Flayou, Kaoutar; Kouam, Nada; Miara, H; Raoundi, O; Ouzeddoun, Naima; Benamar, Loubna; Bayahia, Rabiaa; Rhou, Hakima

2016-01-01

The medical staff could play a major role in promoting for organ donation. The aim of our study was to assess the attitudes of the medical staff toward organ donation. It is a prospective study conducted over a period of six months. A questionnaire was distributed and explained to the medical staff in our institute. Fifteen questions were designed to include four main themes: sociodemographic information, attitude toward organ donation, perceived knowledge about organ donation, and reasons for refusal or acceptance of organ donation. Among the 245 respondents, 36.3% had prior knowledge about organ transplantation, 31.8% knew about the law of organ donation, 43.2% had already donated blood sometimes, 65.7% expressed their consent to organ donation during their lifetime, and 82.8% expressed their agreement to donation after their death. The grounds for refusal were generally: a misunderstanding of risks, desire for respect of corpse. The religious and the ethical motive were present too as a ground for decision making. The medical staff is the key for organ donation. To promote organ transplantation, personnel should be well informed about ethical, moral, and religious dimensions of organ donation and transplantation.

Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

PubMed

Mitchiguian Hotta, Livia; Cardinalli Adler, Ubiratan; de Toledo Cesar, Amarilys; Martinez, Edson Zangiacomi; Demarzo, Marcelo Marcos Piva

2018-05-01

 Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma.  The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol ( Organon.modus ) on perennial asthma in adolescents.  Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. a secondary care medical specialist centre. continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit.  Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 ( p  = 0.18); median number of days of fenoterol use per patient: 3 versus 5 ( p  = 0.41); visits to an emergency room: 1 versus 6 ( p  = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% ( p  = 0.05). Few Adverse Events were reported.  This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating homeopathy on teenage asthma, when performed by specialists following a standardised clinical-pharmaceutical homeopathic protocol.  RBR-6XTS8Z. The Faculty of Homeopathy.

Development and Evaluation of a Pedagogical Tool to Improve Understanding of a Quality Checklist: A Randomised Controlled Trial

PubMed Central

Fourcade, Lola; Boutron, Isabelle; Moher, David; Ronceray, Lucie; Baron, Gabriel; Ravaud, Philippe

2007-01-01

Objective: The aim of this study was to develop and evaluate a pedagogical tool to enhance the understanding of a checklist that evaluates reports of nonpharmacological trials (CLEAR NPT). Design: Paired randomised controlled trial. Participants: Clinicians and systematic reviewers. Interventions: We developed an Internet-based computer learning system (ICLS). This pedagogical tool used many examples from published randomised controlled trials to demonstrate the main coding difficulties encountered when using this checklist. Randomised participants received either a specific Web-based training with the ICLS (intervention group) or no specific training. Outcome measures: The primary outcome was the rate of correct answers compared to a criterion standard for coding a report of randomised controlled trials with the CLEAR NPT. Results: Between April and June 2006, 78 participants were randomly assigned to receive training with the ICLS (39) or no training (39). Participants trained by the ICLS did not differ from the control group in performance on the CLEAR NPT. The mean paired difference and corresponding 95% confidence interval was 0.5 (−5.1 to 6.1). The rate of correct answers did not differ between the two groups regardless of the CLEAR NPT item. Combining both groups, the rate of correct answers was high or items related to allocation sequence (79.5%), description of the intervention (82.0%), blinding of patients (79.5%), and follow-up schedule (83.3%). The rate of correct answers was low for items related to allocation concealment (46.1%), co-interventions (30.3%), blinding of outcome assessors (53.8%), specific measures to avoid ascertainment bias (28.6%), and intention-to-treat analysis (60.2%). Conclusions: Although we showed no difference in effect between the intervention and control groups, our results highlight the gap in knowledge and urgency for education on important aspects of trial conduct. PMID:17479163

Changes in body weight and food choice in those attempting smoking cessation: a cluster randomised controlled trial

PubMed Central

2012-01-01

Background Fear of weight gain is a barrier to smoking cessation and significant cause of relapse for many people. The provision of nutritional advice as part of a smoking cessation programme may assist some in smoking cessation and perhaps limit weight gain. The aim of this study was to determine the effect of a structured programme of dietary advice on weight change and food choice, in adults attempting smoking cessation. Methods Cluster randomised controlled design. Classes randomised to intervention commenced a 24-week intervention, focussed on improving food choice and minimising weight gain. Classes randomised to control received “usual care”. Results Twenty-seven classes in Greater Glasgow were randomised between January and August 2008. Analysis, including those who continued to smoke, showed that actual weight gain and percentage weight gain was similar in both groups. Examination of data for those successful at giving up smoking showed greater mean weight gain in intervention subjects (3.9 (SD 3.1) vs. 2.7 (SD 3.7) kg). Between group differences were not significant (p = 0.23, 95% CI −0.9 to 3.5). In comparison to baseline improved consumption of fruit and vegetables and breakfast cereal were reported in the intervention group. A higher percentage of control participants continued smoking (74% vs. 66%). Conclusions The intervention was not successful at minimising weight gain in comparison to control but was successful in facilitating some sustained improvements in the dietary habits of intervention participants. Improved quit rates in the intervention group suggest that continued contact with advisors may have reduced anxieties regarding weight gain and encouraged cessation despite weight gain. Research should continue in this area as evidence suggests that the negative effects of obesity could outweigh the health benefits achieved through reductions in smoking prevalence. Trial registration Current Controlled Trials ISRCTN73824458 PMID:22642755

Knowledge and behavior towards voluntary blood donation among students of a tertiary institution in Nigeria.

PubMed

Salaudeen, A G; Odeh, E

2011-01-01

Blood donation is the only way of acquiring blood to meet emergency requirements in cases of road traffic accidents, complications of pregnancy and childbirth, various anemic disorders and surgical emergencies among others. Globally, 80 million units of blood are donated each year, but only two million units are donated in sub-Saharan Africa where the need is enormous. The objective of this study was to determine the behavior of the students of a tertiary institution in Nigeria towards voluntary blood donation. This is a descriptive cross-sectional study, which involved students of a tertiary institution in Nigeria. A multistage sampling technique was employed in selecting the participants for this study. A semi-structured self-administered questionnaire was used to collect information on socio-demographic characteristics, knowledge, attitude and factors affecting voluntary blood donation. The data obtained were analyzed using EPI-INFO 2005 software Version 3.3.2. Less than two-thirds (61%) of total respondents had good knowledge of blood donation. More than three quarters (85%) of the respondents had never donated blood. Of the 15% that had donated, only 3% donated voluntarily. Among those that had ever donated, males (57%) were more than females. Many of the donors donated for relatives (57%). The majority of the respondents were compelled to donate because of emergency situations (75%). The reasons why many did not donate were lack of opportunity (45%) due to tight lecture schedule and inadequate knowledge (24%). Gift items such as hematinics, T-shirts and wrist bands (29%) would motivate respondents to donate. The Students' Union body and other Organizations in the University should include a blood donation drive in their monthly/annual activities. The University authorities, the University health service centre and the Hematology Department of the Teaching hospital should collaborate in promoting voluntary blood donation among the students.

Public awareness of blood donation in Central Saudi Arabia

PubMed Central

Abolfotouh, Mostafa A; Al-Assiri, Mohammed H; Al-Omani, Manar; Al Johar, Alwaleed; Al Hakbani, Abdulaziz; Alaskar, Ahmed S

2014-01-01

Introduction In Saudi Arabia, voluntary donors are the only source of blood donation. The aim of this study was to assess the level of public knowledge and attitude toward blood donation in Saudi Arabia. Methods Using a previously validated questionnaire that comprises 38 questions to assess the levels of knowledge, attitudes, and motivations towards blood donation, 469 Saudi adults who attended different shopping malls in Riyadh, Saudi Arabia were surveyed. Multiple regression analyses were used to identify the significant predictors of blood donation, with the significance set at P<0.05. Results Approximately half of all subjects (53.3%) reported that they had previously donated blood, 39% of whom had donated more than once. The knowledge percentage mean score was 58.07%, denoting a poor level of knowledge, with only 11.9% reporting a good level of knowledge. The attitude percentage mean score towards donation was 75.45%, reflecting a neutral attitude towards donating blood, with 31.6% reporting a positive attitude. Donation was significantly more prevalent among males than females (66% versus 13.3%; P<0.001). After adjustment for confounders, a higher knowledge score (t=2.59; P=0.01), a higher attitude score (t=3.26; P=0.001), and male sex (t=10.45; P<0.001) were significant predictors of blood donation. An inability to reach the blood donation centers and a fear of anemia were the main reasons for females not donating blood (49.9% and 35.7%, respectively), whereas a lack of time was the main reason for males (59.5%). Conclusion Prevalence of blood donation was less than satisfactory among the Saudi public, probably due to misconceptions, poor knowledge, and unfavorable attitude to donation. Educational programs are necessary to increase the level of knowledge and improve the attitude of the Saudi public toward blood donation. Providing mobile blood collection units nearer to individuals’ places of work to reduce their time costs of donating is a necessity. PMID:25152628

A Randomised Controlled Trial of the Use of a Piece of Commercial Software for the Acquisition of Reading Skills

ERIC Educational Resources Information Center

Khan, Muhammad Ahmad; Gorard, Stephen

2012-01-01

We report here the overall results of a cluster randomised controlled trial of the use of computer-aided instruction with 672 Year 7 pupils in 23 secondary school classes in the north of England. A new piece of commercial software, claimed on the basis of publisher testing to be effective in improving reading after just six weeks of use in the…

Blood donation behaviour and beliefs among a sample of high school students in Mmabatho.

PubMed

Mwaba, K; Keikelame, M J

1995-08-01

This study was aimed at establishing the extent of blood donation and beliefs about donating blood among high school students in Mmabatho. A random sample of 40 Standard 10 students (20 males, 20 females; mean age = 20.8 years) was selected to participate in the study. A structured questionnaire was used to determined blood donation behaviour and accompanying beliefs. The results showed that although 80 percent of the participants believed that donating blood was important only 17.5 percent had actually ever donated blood. The data also showed that donating blood was a health risk or were uncertain if donating blood was safe. It is recommended that public appeals for blood donors should include information to dispel myths about dangers of donating blood.

Effectiveness of educational poster on knowledge of emergency management of dental trauma--part 2: cluster randomised controlled trial for secondary school students.

PubMed

Young, Cecilia; Wong, Kin Yau; Cheung, Lim K

2014-01-01

To investigate the effectiveness of educational poster on improving secondary school students' knowledge of emergency management of dental trauma. A cluster randomised controlled trial was conducted. 16 schools with total 671 secondary students who can read Chinese or English were randomised into intervention (poster, 8 schools, 364 students) and control groups (8 schools, 305 students) at the school level. Baseline knowledge of dental trauma was obtained by a questionnaire. Poster containing information of dental trauma management was displayed in a classroom for 2 weeks in each school in the intervention group whereas in the control group there was no display of such posters. Students of both groups completed the same questionnaire after 2 weeks. Two-week display of posters improved the knowledge score by 1.25 (p-value = 0.0407) on average. Educational poster on dental trauma management significantly improved the level of knowledge of secondary school students in Hong Kong. HKClinicalTrial.com HKCTR-1343 ClinicalTrials.gov NCT01809457.

Asian American adolescents' willingness to donate organs and engage in family discussion about organ donation and transplantation.

PubMed

Trompeta, Joyce A; Cooper, Bruce A; Ascher, Nancy L; Kools, Susan M; Kennedy, Christine M; Chen, Jyu-Lin

2012-03-01

Despite the growing need for organ donation among Asian Americans, studies suggest that they are reluctant to donate. To examine the association of attitudes and knowledge about organ donation and transplantation with willingness to donate and willingness to engage in family discussion about organ donation among Asian American adolescents. A cross-sectional study. The Big Island of Hawaii. Self-identified Asian American adolescents (Japanese, Chinese, Filipino, Korean), ages 16 to 17 years old, and each adolescent's parent or guardian. Asian American adolescents provided demographic information and completed the Modified Organ Donation Attitude Survey, the Organ Donation and Transplantation Knowledge Survey, and the Suinn-Lew Asian Self-Identity Acculturation Scale. A parent or guardian also provided demographic information. Linear regression analyses were used to examine the associations with willingness to donate and to engage in family discussion about organ discussion. Willingness to donate was associated with positive knowledge related to general aspects about organ donation and cultural limitations in receiving an organ transplant, a high level of acculturation, and a low level of negative attitudes (R2 = 0.402, F = 18.86, P = .005). Asian American adolescents with approving or positive attitudes were likely to engage in family discussion about organ donation (R2 = 0.195, F = 27.93, P = .005). To reinforce and maintain high levels of knowledge and positive attitudes, organ donation education is most likely needed in high schools.

Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).

PubMed

Turner, E L; Metcalfe, C; Donovan, J L; Noble, S; Sterne, J A C; Lane, J A; Avery, K N; Down, L; Walsh, E; Davis, M; Ben-Shlomo, Y; Oliver, S E; Evans, S; Brindle, P; Williams, N J; Hughes, L J; Hill, E M; Davies, C; Ng, S Y; Neal, D E; Hamdy, F C; Martin, R M

2014-06-10

Screening for prostate cancer continues to generate controversy because of concerns about over-diagnosis and unnecessary treatment. We describe the rationale, design and recruitment of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP) trial, a UK-wide cluster randomised controlled trial investigating the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing. Seven hundred and eighty-five general practitioner (GP) practices in England and Wales were randomised to a population-based PSA testing or standard care and then approached for consent to participate. In the intervention arm, men aged 50-69 years were invited to undergo PSA testing, and those diagnosed with localised prostate cancer were invited into a treatment trial. Control arm practices undertook standard UK management. All men were flagged with the Health and Social Care Information Centre for deaths and cancer registrations. The primary outcome is prostate cancer mortality at a median 10-year-follow-up. Among randomised practices, 271 (68%) in the intervention arm (198,114 men) and 302 (78%) in the control arm (221,929 men) consented to participate, meeting pre-specified power requirements. There was little evidence of differences between trial arms in measured baseline characteristics of the consenting GP practices (or men within those practices). The CAP trial successfully met its recruitment targets and will make an important contribution to international understanding of PSA-based prostate cancer screening.

41 CFR 109-44.702 - Donations to public bodies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Donations to public... AND DISPOSAL 44-DONATION OF PERSONAL PROPERTY 44.7-Donations of Property to Public Bodies § 109-44.702 Donations to public bodies. ...

45 CFR 2544.115 - Who may offer a donation?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Who may offer a donation? 2544.115 Section 2544... COMMUNITY SERVICE SOLICITATION AND ACCEPTANCE OF DONATIONS § 2544.115 Who may offer a donation? Anyone... donation to the Corporation. ...

45 CFR 2544.115 - Who may offer a donation?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false Who may offer a donation? 2544.115 Section 2544... COMMUNITY SERVICE SOLICITATION AND ACCEPTANCE OF DONATIONS § 2544.115 Who may offer a donation? Anyone... donation to the Corporation. ...

45 CFR 2544.115 - Who may offer a donation?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false Who may offer a donation? 2544.115 Section 2544... COMMUNITY SERVICE SOLICITATION AND ACCEPTANCE OF DONATIONS § 2544.115 Who may offer a donation? Anyone... donation to the Corporation. ...

41 CFR 109-44.702 - Donations to public bodies.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false Donations to public... AND DISPOSAL 44-DONATION OF PERSONAL PROPERTY 44.7-Donations of Property to Public Bodies § 109-44.702 Donations to public bodies. ...

41 CFR 109-44.702 - Donations to public bodies.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false Donations to public... AND DISPOSAL 44-DONATION OF PERSONAL PROPERTY 44.7-Donations of Property to Public Bodies § 109-44.702 Donations to public bodies. ...

45 CFR 2544.115 - Who may offer a donation?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false Who may offer a donation? 2544.115 Section 2544... COMMUNITY SERVICE SOLICITATION AND ACCEPTANCE OF DONATIONS § 2544.115 Who may offer a donation? Anyone... donation to the Corporation. ...

41 CFR 109-44.702 - Donations to public bodies.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false Donations to public... AND DISPOSAL 44-DONATION OF PERSONAL PROPERTY 44.7-Donations of Property to Public Bodies § 109-44.702 Donations to public bodies. ...

45 CFR 2544.115 - Who may offer a donation?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false Who may offer a donation? 2544.115 Section 2544... COMMUNITY SERVICE SOLICITATION AND ACCEPTANCE OF DONATIONS § 2544.115 Who may offer a donation? Anyone... donation to the Corporation. ...

41 CFR 109-44.702 - Donations to public bodies.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false Donations to public... AND DISPOSAL 44-DONATION OF PERSONAL PROPERTY 44.7-Donations of Property to Public Bodies § 109-44.702 Donations to public bodies. ...

Importance of education in organ donation.

PubMed

Yilmaz, Tonguc Utku

2011-12-01

Transplanting is the sole therapy for the majority of organ insufficiencies, but the lack of organ donation limits transplanting. We evaluated the effect of education about "Organ Donation and Transplantation" over the false beliefs of the participants. This interventional study was performed in a military unit between January and March 2010. Data on organ donation and demographic characteristics were collected by a questionnaire. The researcher gave the lesson, and then collected the data by the same questionnaire 2 months later. The rate of volunteering for organ donation increased from 45.4% to 84.8% (P < .001). Rate of consent for organ donations by relatives increased from 41% to 80.3% (P < .001). Also, general knowledge about organ donation increased from 34.8% to 93.7% (P < .001). Wrong beliefs about organ donation disappeared after the education. The entire organ donation rate among the volunteer participants increased from 60% to 84% (P < .001). No significant relation was found between volunteering to donate organs, and education and economic status. Education could correct false information and might lead to higher organ donation rates. This education (which gave positive results in a military unit) could become widespread.

Willingness to communicate organ donation intention.

PubMed

McDonald, Deborah Dillon; Ferreri, Ruth; Jin, Carol; Mendez, Anthea; Smail, Julie; Balcom, Patricia; Shoemaker, Sheila; Kamuzora, Paul Lwekaza; Durham, Rebecca; Dibble, Jaqueline

2007-01-01

The study tested an intervention exposing people who planned to donate organs to written information about communicating with family their intention to donate organs. A pretest posttest double-blind experiment compared participants given written information about communicating with family and basic organ donation information, with participants given written information about only basic organ donation information. Participants included 109 adults who had not yet communicated their plans with family. Participants first responded to previous experience with organ donation, thoughts about organ donation, willingness to communicate with family about organ donation, and knowledge about organ donation. After reading the respective pamphlet, participants again responded to thoughts about communicating with their family and willingness to communicate with family. Both groups responded with the same high willingness to communicate before the intervention and a small but significant increase in willingness to communicate afterwards. Participants expressed a high degree of willingness to communicate about their organ donation intentions even though they had thus far not communicated their intentions. Factors in addition to willingness to communicate need to be identified in order to encourage better communication about organ donation intentions.

Encouraging family discussion on the decision to donate organs: the role of the willingness to communicate scale.

PubMed

Smith, Sandi W; Kopfman, Jenifer E; Lindsey, Lisa L Massi; Yoo, Jina; Morrison, Kelly

2004-01-01

Family discussion of organ donation has been found to double rates of family consent regarding organ donation. Therefore, family discussion is an important communication process to study in the effort to get more people to become organ donors. This investigation concerns the willingness to communicate about organ donation and its relationship to other variables and processes related to family discussion of organ donation. Previous research on willingness to communicate examined the antecedent variables of knowledge, attitude toward organ donation, and altruism. This research found that being willing to communicate about organ donation with one's family is related to prior thought and intent to sign an organ donor card, to perceiving organ donation messages as credible, and to feeling relatively low anxiety after reading organ donation messages. One week after being presented with the messages, willingness to communicate was found to be positively associated with worrying about the lack of donors, engaging in family discussion about organ donation, and having an organ donor card witnessed. It was negatively related to feeling personally uneasy about organ donation during the past week.

[The effects of charity advertising on donations and donors' explicit and implicit evaluations of recipients].

PubMed

Kawamura, Yuta; Kusumi, Takashi

2015-04-01

Advertisements for charity generally employ one of two advertising strategies. The first appeals to the efficacy of support, while the second appeals to the necessity of support. Two experiments investigated the effect of each type of charity advertising on donations and on donors' explicit and implicit evaluations of the recipients. The results indicated that although participants' explicit evaluations of charity recipients were not changed by efficacy-based advertising, they were negatively influenced by necessity-based advertising. Furthermore, Experiment 1 detected moderating effects of empathic concern. The explicit evaluations of participants in the necessity-based advertising group were negatively correlated with their empathic concern. Implicit evaluations were consistently negative in both groups. Both advertising strategies were more effective at securing donations than the control group, which did not use any strategies. These findings suggest practical implications for charity advertising.

Evolution of deceased organ donation activity vs. efficiency over a 15 year period: an international comparison.

PubMed

Weiss, Julius; Elmer, Andreas; Mahíllo, Beatriz; Domínguez-Gil, Beatriz; Avsec, Danica; Costa, Alessandro Nanni; Haase-Kromwijk, Bernadette J J M; Laouabdia, Karim; Immer, Franz F

2018-04-19

The donation rate (DR) per million population is not ideal for an efficiency comparison of national deceased organ donation programs. The DR does not account for variabilities in the potential for deceased donation which mainly depends on fatalities from causes leading to brain death. In this study, the donation activity was put into relation to the mortality from selected causes. Based on that metric, this study assesses the efficiency of different donation programs. This is a retrospective analysis of 2001-2015 deceased organ donation and mortality registry data. Included are 27 Council of Europe countries, as well as the USA. A donor conversion index (DCI) was calculated for assessing donation program efficiency over time and in international comparisons. According to the DCI and of the countries included in the study, Spain, France, and the USA had the most efficient donation programs in 2015. Even though mortality from the selected causes decreased in most countries during the study period, differences in international comparisons persist. This indicates that the potential for deceased organ donation and its conversion into actual donation is far from being similar internationally. Compared with the DR, the DCI takes into account the potential for deceased organ donation, and therefore is a more accurate metric of performance. National donation programs could optimize performance by identifying the areas where most potential is lost, and by implementing measures to tackle these issues.

Subsequent donation requests among 2472 unrelated hematopoietic progenitor cell donors are associated with bone marrow harvest

PubMed Central

Lown, Robert N.; Tulpule, Sameer; Russell, Nigel H.; Craddock, Charles F.; Roest, Rochelle; Madrigal, J. Alejandro; Shaw, Bronwen E.

2013-01-01

Approximately 1 in 20 unrelated donors are asked to make a second donation of hematopoietic progenitor cells, the majority for the same patient. Anthony Nolan undertook a study of subsequent hematopoietic progenitor cell donations made by its donors from 2005 to 2011, with the aims of predicting those donors more likely to be called for a second donation, assessing rates of serious adverse reactions and examining harvest yields. This was not a study of factors predictive of second allografts. During the study period 2591 donations were made, of which 120 (4.6%) were subsequent donations. The median time between donations was 179 days (range, 21–4016). Indications for a second allogeneic transplant included primary graft failure (11.7%), secondary graft failure (53.2%), relapse (30.6%) and others (1.8%). On multivariate analysis, bone marrow harvest at first donation was associated with subsequent donation requests (odds ratio 2.00, P=0.001). The rate of serious adverse reactions in donors making a subsequent donation appeared greater than the rate in those making a first donation (relative risk=3.29, P=0.005). Harvest yields per kilogram recipient body weight were equivalent between donations, although females appeared to have a lower yield at the subsequent donation. Knowledge of these factors will help unrelated donor registries to counsel their donors. PMID:23812935

Risk factors for complications in donors at first and repeat whole blood donation: a cohort study with assessment of the impact on donor return.

PubMed

Wiersum-Osselton, Johanna C; Marijt-van der Kreek, Tanneke; Brand, Anneke; Veldhuizen, Ingrid; van der Bom, Johanna G; de Kort, Wim

2014-01-01

First-time donation is among recognised risk factors for vasovagal reactions to blood donation and reactions are known to reduce donor return. We assessed associations between potential risk factors and vasovagal reactions and needle-related complications in first-time whole blood donation in comparison to repeat donation and analysed the impact of complications on donor return. We performed a cohort study on whole blood donations in The Netherlands from 1/1/2010 to 31/12/2010 using data extracted from the blood service information system. Donation data up to 31/12/2011 were used to ascertain donor return. In 2010 28,786 donors made first whole blood donations and there were 522,958 repeat donations. Vasovagal reactions occurred in 3.9% of first donations by males and 3.5% of first donations by females compared to in 0.2% and 0.6%, respectively, of repeat donations. Associations of vasovagal reactions with other factors including age, body weight, systolic and diastolic blood pressure were similar in first-time and repeat donors. Needle-related complications occurred in 0.2% of male and 0.5% of female first-time donations and in 0.1% and 0.3%, respectively, of repeat donations. Among first-time donors, the return rate within 1 year was 82% following an uncomplicated first donation, but 55% and 61% following vasovagal reactions and needle-related complications, respectively; the corresponding percentages among repeat donors were 86%, 58% and 82%. Among first-time donors, females suffered less than males from vasovagal reactions. Other risk factors had similar associations among first-time and repeat donors. Vasovagal reactions and needle-related complications in both first-time and repeat donors are followed by reduced donor return.

Donor Experiences of Second Marrow or Peripheral Blood Stem Cell Collection Mirror the First, but CD34+ Yields Are Less.

PubMed

Stroncek, David F; Shaw, Bronwen E; Logan, Brent R; Kiefer, Deidre M; Savani, Bipin N; Anderlini, Paolo; Bredeson, Christopher N; Hematti, Peiman; Ganguly, Siddhartha; Diaz, Miguel Angel; Abdel-Azim, Hisham; Ahmed, Ibrahim; Maharaj, Dipnarine; Seftel, Matthew; Beitinjaneh, Amer; Seo, Sachiko; Yared, Jean A; Halter, Joerg; O'Donnell, Paul V; Hale, Gregory A; DeFilipp, Zachariah; Lazarus, Hillard; Liesveld, Jane L; Zhou, Zheng; Munshi, Pashna; Olsson, Richard F; Kasow, Kimberly Anne; Szer, Jeffrey; Switzer, Galen E; Chitphakdithai, Pintip; Shah, Nirali; Confer, Dennis L; Pulsipher, Michael A

2018-01-01

Little is known about the experiences of individuals donating peripheral blood stem cells (PBSCs) or marrow for a second time. To study this, unrelated donors making a second donation through the National Marrow Donor Program between 2004 and 2013 were evaluated. Experiences of second-time donors giving marrow (n = 118: first donation was PBSC in 76 and marrow in 42) were compared with those making only 1 marrow donation (n = 5829). Experiences of second-time donors giving PBSCs (n = 602) (first donation was PBSCs in 362; marrow in 240) were compared to first-time PBSC donors (n = 16,095). For donors giving a second PBSC or marrow donation there were no significant differences in maximum skeletal pain, maximum symptoms measured by an established modified toxicity criteria, and recovery time compared with those who donated only once. Notably, the yield of marrow nucleated cells and PBSC CD34 + cells with second donations was less. As previously noted with single first-time donations, female (PBSCs and marrow) and obese donors (PBSCs) had higher skeletal pain and/or toxicity with a second donation. PBSC donors who experienced high levels of pain or toxicity with the first donation also experienced high levels of these symptoms with their second donation and slower recovery times. In conclusion, for most donors second donation experiences were similar to first donation experiences, but CD34 + yields were less. Knowledge of the donor's first experience and stem cell yields may help centers decide whether second donations are appropriate and institute measures to improve donor experiences. Copyright © 2017 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework.

PubMed

Jull, J; Whitehead, M; Petticrew, M; Kristjansson, E; Gough, D; Petkovic, J; Volmink, J; Weijer, C; Taljaard, M; Edwards, S; Mbuagbaw, L; Cookson, R; McGowan, J; Lyddiatt, A; Boyer, Y; Cuervo, L G; Armstrong, R; White, H; Yoganathan, M; Pantoja, T; Shea, B; Pottie, K; Norheim, O; Baird, S; Robberstad, B; Sommerfelt, H; Asada, Y; Wells, G; Tugwell, P; Welch, V

2017-09-25

Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. A randomised trial can usefully be classified as 'health equity relevant' if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as 'health equity relevant' may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[Can one authorize oocyte donation in the Grand Duchy of Luxembourg?].

PubMed

Arendt, J

2012-01-01

In the case of early ovary extinction, the only way to have a child is either adoption or egg/embryo reception by donation. To day, egg donation is prohibited in Luxembourg by ministerial decision in 2003. Germ cell donation is part of artificial reproductive therapy. Oocyte donation, in particular, needs to be done by IVF treatment, which makes it more complicated then sperm donation What makes it more difficult is the fact that there are no oocyte bank yet. Today, prohibition encourages procreative tourism what only wealthy people can afford. Although donation programs are well established many questions arise about egg donation such as refunds, divulging information, women's age limit, health insurance participation.

When do next-of-kin opt-in? Anticipated regret, affective attitudes and donating deceased family member's organs.

PubMed

Shepherd, Lee; O'Carroll, Ronan E

2014-12-01

This research assessed whether affective factors promote and prevent family members from donating their loved one's organs. Participants (N = 191) imagined that a family member had died and that they had to decide whether or not to donate their organs and body parts for transplantation purposes. The least organs and body parts were donated when the deceased opposed donation. Moreover, participants who were not registered organ donors donated fewer organs than registered donors. This effect was mediated by anticipated regret, disgust and the perceived benefits of donation. Organ donation campaigns should target such factors to increase donor rates. © The Author(s) 2013.

Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson's disease: a pilot randomised controlled trial (PD COMM pilot).

PubMed

Sackley, Catherine M; Smith, Christina H; Rick, Caroline E; Brady, Marian C; Ives, Natalie; Patel, Smitaa; Woolley, Rebecca; Dowling, Francis; Patel, Ramilla; Roberts, Helen; Jowett, Sue; Wheatley, Keith; Kelly, Debbie; Sands, Gina; Clarke, Carl E

2018-01-01

Speech-related problems are common in Parkinson's disease (PD), but there is little evidence for the effectiveness of standard speech and language therapy (SLT) or Lee Silverman Voice Treatment (LSVT LOUD®). The PD COMM pilot was a three-arm, assessor-blinded, randomised controlled trial (RCT) of LSVT LOUD®, SLT and no intervention (1:1:1 ratio) to assess the feasibility and to inform the design of a full-scale RCT. Non-demented patients with idiopathic PD and speech problems and no SLT for speech problems in the past 2 years were eligible. LSVT LOUD® is a standardised regime (16 sessions over 4 weeks). SLT comprised individualised content per local practice (typically weekly sessions for 6-8 weeks). Outcomes included recruitment and retention, treatment adherence, and data completeness. Outcome data collected at baseline, 3, 6, and 12 months included patient-reported voice and quality of life measures, resource use, and assessor-rated speech recordings. Eighty-nine patients were randomised with 90% in the therapy groups and 100% in the control group completing the trial. The response rate for Voice Handicap Index (VHI) in each arm was ≥ 90% at all time-points. VHI was highly correlated with the other speech-related outcome measures. There was a trend to improvement in VHI with LSVT LOUD® (difference at 3 months compared with control: - 12.5 points; 95% CI - 26.2, 1.2) and SLT (difference at 3 months compared with control: - 9.8 points; 95% CI - 23.2, 3.7) which needs to be confirmed in an adequately powered trial. Randomisation to a three-arm trial of speech therapy including a no intervention control is feasible and acceptable. Compliance with both interventions was good. VHI and other patient-reported outcomes were relevant measures and provided data to inform the sample size for a substantive trial. International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. registered 22 March 2012.

Does an intensive self-management structured education course improve outcomes for children and young people with type 1 diabetes? The Kids In Control OF Food (KICk-OFF) cluster-randomised controlled trial protocol

PubMed Central

Price, Katherine J; Wales, Jerry; Eiser, Christine; Knowles, Julie; Heller, Simon; Freeman, Jenny; Brennan, Alan; McPherson, Amy; Wellington, Jerry

2013-01-01

Introduction The Kids In Control OF Food (KICk-OFF) is a cluster-randomised controlled trial, which aims to determine the efficacy of a 5 day structured education course for 11-year-olds to 16-year-olds with type 1 diabetes (T1DM) when compared with standard care, and its cost effectiveness. Less than 15% of children and young people with T1DM in the UK meet the recommended glycaemic target. Self-management education programmes for adults with T1DM improve clinical and psychological outcomes, but none have been evaluated in the paediatric population. KICk-OFF is a 5-day structured education course for 11-year-olds to 16- year-olds with T1DM. It was developed with input from young people, parents, teachers and educationalists. Methods and analysis 36 paediatric diabetes centres across the UK randomised into intervention and control arms. Up to 560 participants were recruited prior to centre randomisation. KICk-OFF courses are delivered in the intervention centres, with standard care continued in the control arm. Primary outcomes are change in glycaemic control (HbA1c) and quality of life between baseline and 6 months postintervention, and the incidence of severe hypoglycaemia. Sustained change in self-management behaviour is assessed by follow-up at 12 and 24 months. Health economic analysis will be undertaken. Data will be reported according to the CONSORT statement for cluster-randomised clinical trials. All analyses will be by intention-to-treat with a two-sided p value of <0.05 being regarded as statistically significant. The study commenced in 2008. Data collection from participants is ongoing and the study will be completed in 2013. Ethics The study has been approved by the Sheffield Research Ethics Committee. Dissemination Results will be reported in peer reviewed journals and conferences. Trial registration Current Controlled Trials ISRCTN37042683. PMID:23355675

Randomised controlled trial of biofeedback training in persistent encopresis with anismus.

PubMed

Nolan, T; Catto-Smith, T; Coffey, C; Wells, J

1998-08-01

Paradoxical external anal sphincter contraction during attempted defecation (anismus) is thought to be an important contributor to chronic faecal retention and encopresis in children. Biofeedback training can be used to teach children to abolish this abnormal contraction. A randomised controlled trial in medical treatment resistant and/or treatment dependent children with anismus using surface electromyographic (EMG) biofeedback training to determine whether such training produces sustained faecal continence. Up to four sessions of biofeedback training were conducted at weekly intervals for each patient. Anorectal manometry was performed before randomisation and six months later. Parents of patients completed the "child behaviour checklist" (CBCL) before randomisation and at follow up. Sixty eight children underwent anorectal manometry and EMG. Of these, 29 had anismus (ages 4-14 years) and were randomised to either EMG biofeedback training and conventional medical treatment (BFT) (n = 14) or to conventional medical treatment alone (n = 15). All but one child were able to learn relaxation of the external anal sphincter on attempted defecation. At six months' follow up, laxative free remission had been sustained in two of 14 patients in the BFT group and in two of 15 controls (95% confidence interval (CI) on difference, -24% to 26%). Remission or improvement occurred in four of 14 patients in the BFT group and six of 15 controls (95% CI on difference, -46% to 23%). Of subjects available for repeat anorectal manometry and EMG at six months, six of 13 in the BFT group still demonstrated anismus v 11 of 13 controls (95% CI on difference, -75% to -1%). Of the four patients in full remission at six months, only one (in the BFT group) did not exhibit anismus. Rectal hyposensitivity was not associated with remission or improvement in either of the groups. Mean CBCL total behaviour problem scores were not significantly different between the BFT and control groups, but there was a significant improvement in CBCL school scale scores in the BFT group, and this improvement was significantly greater than that seen in the control group. The result of this study, together with those reported in other controlled trials, argues against using biofeedback training in children with encopresis.

Statistical analysis of donation--transfusion data with complex correlation.

PubMed

Reilly, Marie; Szulkin, Robert

2007-12-30

Blood-borne transmission of disease is estimated from linked data records from blood donors and transfusion recipients. However, such data are characterized by complex correlation due to donors typically contributing many donations and recipients being transfused with multiple units of blood product. In this paper, we present a method for analysing such data, by using a modification of a nested case-control design. For recipients who develop the disease of interest (cases) and their matched controls, all donors who contributed blood to these individuals define clusters or 'families' of related individuals. Using a Cox regression model for the hazard of the individuals within clusters of donors, we estimate the risk of transmission, and a bootstrap step provides valid standard errors provided the clusters are independent. As an illustration, we apply the method to the analysis of a large database of Swedish donor and recipient records linked to the population cancer register. We investigate whether there is an increased risk of cancer in recipients transfused with blood from donors who develop cancer after donating. Our method provides a powerful alternative to the small 'look-back' studies typical of transfusion medicine and can make an important contribution to haemovigilance efforts. Copyright (c) 2007 John Wiley & Sons, Ltd.

Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial -- the HPV FOCAL Study.

PubMed

Ogilvie, G S; Krajden, M; van Niekerk, D J; Martin, R E; Ehlen, T G; Ceballos, K; Smith, L W; Kan, L; Cook, D A; Peacock, S; Stuart, G C E; Franco, E L; Coldman, A J

2012-12-04

Round 1 data of human papillomavirus (HPV) FOCAL, a three-arm, randomised trial, which aims to establish the efficacy of HPV DNA testing as a primary screen for cervical cancer, are presented. The three arms are: Control arm - liquid based cytology with atypical squamous cells of unknown significance (ASC-US) triage with hrHPV testing; Intervention Arm - hrHPV at entry with liquid-based cytology (LBC) triage of hrHPV positives, with exit screen at 4 years; Safety check arm - hrHPV at entry with LBC triage of hrHPV positives with exit screen at 2 years. A total of 6154 women were randomised to the control arm and 12 494 to the HPV arms (intervention and safety check). In the HPV arm, the baseline cervical intraepithelial neoplasia (CIN)2+ and CIN3+ rate was 9.2/1000 (95%CI; 7.4, 10.9) and 4.8/1000 (95%CI; 3.6, 6.1), which increased to 16.1/1000 (95%CI 13.2, 18.9) for CIN2+ and to 8.0/1000 (95%CI; 5.9, 10.0) for CIN3+ after subsequent screening of HPV-DNA-positive/cytology-negative women. Detection rate in the control arm remained unchanged after subsequent screening of ASC-US-positive/hrHPV DNA-negative women at 11.0/1000 for CIN2+ and 5.0/1000 for CIN3+. After subsequent screening of women who were either hrHPV positive/cytology negative or ASC-US positive/HPV negative, women randomised to the HPV arms had increased CIN2+ detection compared with women randomised to the cytology arm.

A randomised controlled trial of clinics in secondary schools for adolescents with asthma.

PubMed Central

Salisbury, Chris; Francis, Caia; Rogers, Chris; Parry, Kate; Thomas, Huw; Chadwick, Stephanie; Turton, Pat

2002-01-01

AIM: To compare a nurse-led clinic in schools versus care in general practice for adolescents with asthma. DESIGN OF STUDY: Randomised controlled trial in four schools; parallel observational study in two schools. SETTING: Six comprehensive schools. METHOD: In the randomised trial, pupils were invited to attend asthma review at a nurse-led clinic either in school, or in general practice. The parallel observational study compared pupils invited to practice care within and outside the randomised trial. Primary outcome measures were attendance for asthma review, symptom control, and quality of life. Secondary outcomes were knowledge, attitudes, inhaler technique, use of steroids, school absence, peak flow rate, preference for future care, health service utilisation, and costs. RESULTS: School clinic pupils were more likely to attend an asthma review than those randomised to practice care (90.8% versus 51.0% overall [P < 0.001, not consistent across schools]). No differences were observed in symptom control (P = 0.42) or quality of life (P = 0.63). Pupils attending school clinics had greater knowledge of asthma (difference = +0.38, 95% CI = 0.19 to 0.56), more positive attitudes (difference = +0.21, 95% CI = 0.05 to 0.36), and better inhaler technique (P < 0.001, not consistent across all schools). No differences were observed in school absence or peak flow rate. A majority (63%) of those who had received care at school preferred this model in future. Median costs of providing care at school and at the practice were 32.10 Pounds and 19.80 Pounds, respectively. No differences were observed between the groups in the observational comparison on any outcome. CONCLUSIONS: The schools asthma clinic increased uptake of asthma reviews. There were improvements in various process measures, but not in clinical outcomes. PMID:12528584

Mass media, online social network, and organ donation: old mistakes and new perspectives.

PubMed

Aykas, A; Uslu, A; Şimşek, C

2015-05-01

Contrary to TV programs projecting awareness about organ donation in society, concrete evidence exists about adverse influence of negative broadcasts on organ donation rates. We sought to determine the effect of mass media on public opinion toward organ donation and the efficacy of public campaigns and novel social media attempts on donation rates. We conducted a systematic review of relevant literature and national campaign results. Hoaxes about brain death and organ transplantation adversely affect organ donation rates in both Western and Eastern societies. Scientifically controversial and exaggerated press conferences and institutional advertisements create mistrust in doctors, thus reducing organ donation. The overall effect of public education campaigns in promoting organ donation is a temporary 5% gain. Increments in organ donation rates is expected with novel applications of social media (Facebook effect). Communication, based on mutual trust, must be established between medicine and the media. Continuing education programs with regard to public awareness on organ donation should be conducted over social media. Copyright © 2015 Elsevier Inc. All rights reserved.

Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders

PubMed Central

Lamb, Sarah E; Gates, Simon; Underwood, Martin R; Cooke, Matthew W; Ashby, Deborah; Szczepura, Ala; Williams, Mark A; Williamson, Esther M; Withers, Emma J; Mt Isa, Shahrul; Gumber, Anil

2007-01-01

Background A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. Methods Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. Conclusion This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised. PMID:17257408

Non-donors' attitudes towards sperm donation and their willingness to donate.

PubMed

Provoost, Veerle; Van Rompuy, Florence; Pennings, Guido

2018-01-01

The aim of this article is to study attitudes about sperm donation and willingness to donate sperm in students who have never shown an interest in sperm donation. The method used in this study is an electronic survey of 1012 male students. Only one third of the respondents (34.3%) would consider donating sperm. Overall, 85.7% indicated a positive attitude towards sperm donation while 14.3% indicated a neutral or negative attitude. The highest scored barriers to donating were the lack of practical information and the fear that the partner would not agree. Almost 40% of the respondents feared that the donation might have a negative impact on their current or future relationship. The majority (83.6%) of those who considered donating thought donors should receive a financial compensation. Money was also one of the main motivators. About 85% of the students thought positively about sperm donation but several factors such as perceived negative views by the social environment, especially the partner, may deter students from donating. This study indicates that the effect of strong incentives, for instance in monetary terms, on a donor pool consisting of students could be limited and that relational factors and donor's perceptions of the views of the wider social network should be taken into account when recruiting donors.

Knowledge, Attitudes, and Motivations towards Blood Donation among King Abdulaziz Medical City Population.

PubMed

Alfouzan, Najd

2014-01-01

Background. Blood donation is remarkably safe medical procedure. However, attitudes, beliefs, and level of knowledge may affect it. Objectives. To measure the level of knowledge regarding blood donation, find out positive and negative attitudes, identify the obstacles, and suggest some motivational factors. Methodology. A cross-sectional study was conducted at King Abdulaziz Medical City (KAMC). Participants were selected by convenient nonrandom sampling technique. A self-created questionnaire was used for data collection. Results. The study included 349 individuals. About 45.8% of the participants claimed that they have a history of blood donation. Reported causes for not donating blood were blood donation not crossing their mind (52.4%), no time for donation (45%), and difficulty in accessing blood donation center (41.3%). Reported motivating factors for donating blood were one day off (81.4%), mobile blood donation caravans in public areas (79.1%), token gifts (31.5%), and finally paying money (18.9%). Conclusion. People in the age group 31-50 years, males, higher education and military were more likely to donate blood as well as People who showed higher knowledge level and positive attitude towards blood donation. More educational programs to increase the awareness in specific targeted populations and also to focus on some motivational factors are recommended.

Knowledge, Attitudes, and Motivations towards Blood Donation among King Abdulaziz Medical City Population

PubMed Central

2014-01-01

Background. Blood donation is remarkably safe medical procedure. However, attitudes, beliefs, and level of knowledge may affect it. Objectives. To measure the level of knowledge regarding blood donation, find out positive and negative attitudes, identify the obstacles, and suggest some motivational factors. Methodology. A cross-sectional study was conducted at King Abdulaziz Medical City (KAMC). Participants were selected by convenient nonrandom sampling technique. A self-created questionnaire was used for data collection. Results. The study included 349 individuals. About 45.8% of the participants claimed that they have a history of blood donation. Reported causes for not donating blood were blood donation not crossing their mind (52.4%), no time for donation (45%), and difficulty in accessing blood donation center (41.3%). Reported motivating factors for donating blood were one day off (81.4%), mobile blood donation caravans in public areas (79.1%), token gifts (31.5%), and finally paying money (18.9%). Conclusion. People in the age group 31–50 years, males, higher education and military were more likely to donate blood as well as People who showed higher knowledge level and positive attitude towards blood donation. More educational programs to increase the awareness in specific targeted populations and also to focus on some motivational factors are recommended. PMID:25431668

Organ donation education initiatives: A report of the Donor Management Task Force.

PubMed

Michetti, Christopher P; Nakagawa, Thomas A; Malinoski, Darren; Wright, Charles; Swanson, LeAnn

2016-10-01

It is essential that hospitals and health professionals establish systems to facilitate patients' organ donation wishes. Donation education has been neither standardized nor systematic, and resources related to donation processes have not been widely accessible. This report describes 2 free, publicly available educational resources about the organ donation process created to advance the mission of basic education and improve donation processes within hospitals and health care systems. Members of the Donor Management Task Force of the Organ Donation and Transplantation Alliance (the Alliance) and the Health Resources and Services Administration of the US Department of Health and Human Services convened annually in person and by teleconferencing during the year to develop 2 educational vehicles on organ donation. Two educational products were developed: the Organ Donation Toolbox, an online repository of documents and resources covering all aspects of the donation process, and the Educational Training Video that reviews the basic foundations of a successful hospital donation system. There is a need for more research and education about the process of organ donation as it relates to the medical and psychosocial care of patients and families before the end of life. The educational products described can help fill this critical need. Copyright © 2016 Elsevier Inc. All rights reserved.

Understanding the Role of Clergy in African American Organ and Tissue Donation Decision-Making

PubMed Central

Jacob Arriola, Kimberly R.; Perryman, Jennie P.; Doldren, Michelle A.; Warren, Carmen M.; Robinson, Dana H. Z.

2012-01-01

Objectives To describe and understand the attitudes, beliefs, and experiences towards organ and tissue donation among African American clergy in Atlanta, Georgia, USA. The secondary objective is to understand what messages clergy are providing to their parishioners relative to organ and tissue donation, and what their perceived role is in donation education. Design A qualitative study in which African American clergy (n = 26) participated in four focus groups. Results African American clergy, though generally supportive of organ and tissue donation in principle, have serious reservations about donation due to perceived inequalities in the donation and transplantation system. The clergy did not personally hold religious concerns about donation, but expressed that these concerns were a major barrier to donation among their parishioners. None of the clergy knew the written position that their religion took on donation; they acknowledged the need for more education for them and their parishioners on this topic. They also felt that as religious leaders, they could play an important role in promoting organ and tissue donation among African American parishioners. Conclusions African American clergy and religious leaders may play an important role towards improving willingness to donate among African American parishioners, but more education and advocacy is needed to prepare them for this role. PMID:17978944

The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention

PubMed Central

Bialkowski, W.; Bryant, B. J.; Schlumpf, K. S.; Wright, D. J.; Birch, R.; Kiss, J. E.; D’Andrea, P.; Cable, R. G.; Spencer, B. R.; Vij, V.; Mast, A. E.

2014-01-01

Background and Objectives Repeated blood donation produces iron deficiency. Changes in dietary iron intake do not prevent donation-induced iron deficiency. Prolonging the interdonation interval or using oral iron supplements can mitigate donation-induced iron deficiency. The most effective operational methods for reducing iron deficiency in donors are unknown. Materials and Methods ‘Strategies To Reduce Iron Deficiency’ (STRIDE) was a two-year, randomized, placebo-controlled study in blood donors. 692 donors were randomized into one of two educational groups or one of three interventional groups. Donors randomized to educational groups either received letters thanking them for donating, or, suggesting iron supplements or delayed donation if they had low ferritin. Donors randomized to interventional groups either received placebo, 19-mg or 38-mg iron pills. Results Iron deficient erythropoiesis was present in 52.7% of males and 74.6% of females at enrolment. Adverse events within 60 days of enrolment were primarily mild gastrointestinal symptoms (64%). The incidence of de-enrolment within 60 days was more common in the interventional groups than in the educational groups (P = 0.002), but not more common in those receiving iron than placebo (P = 0.68). Conclusion The prevalence of iron deficient erythropoiesis in donors enrolled in the STRIDE study is comparable to previously described cohorts of regular blood donors. De-enrolment within 60 days was higher for donors receiving tablets, although no more common in donors receiving iron than placebo. PMID:25469720

The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention.

PubMed

Bialkowski, W; Bryant, B J; Schlumpf, K S; Wright, D J; Birch, R; Kiss, J E; D'Andrea, P; Cable, R G; Spencer, B R; Vij, V; Mast, A E

2015-02-01

Repeated blood donation produces iron deficiency. Changes in dietary iron intake do not prevent donation-induced iron deficiency. Prolonging the interdonation interval or using oral iron supplements can mitigate donation-induced iron deficiency. The most effective operational methods for reducing iron deficiency in donors are unknown. 'Strategies To Reduce Iron Deficiency' (STRIDE) was a two-year, randomized, placebo-controlled study in blood donors. 692 donors were randomized into one of two educational groups or one of three interventional groups. Donors randomized to educational groups either received letters thanking them for donating, or, suggesting iron supplements or delayed donation if they had low ferritin. Donors randomized to interventional groups either received placebo, 19-mg or 38-mg iron pills. Iron deficient erythropoiesis was present in 52·7% of males and 74·6% of females at enrolment. Adverse events within 60 days of enrolment were primarily mild gastrointestinal symptoms (64%). The incidence of de-enrolment within 60 days was more common in the interventional groups than in the educational groups (P = 0·002), but not more common in those receiving iron than placebo (P = 0·68). The prevalence of iron deficient erythropoiesis in donors enrolled in the STRIDE study is comparable to previously described cohorts of regular blood donors. De-enrolment within 60 days was higher for donors receiving tablets, although no more common in donors receiving iron than placebo. © 2014 International Society of Blood Transfusion.

Effects of structured education program on organ donor designation of nursing students and their families: A randomized controlled trial.

PubMed

Murakami, Minoru; Fukuma, Shingo; Ikezoe, Masaya; Iizuka, Chizuko; Izawa, Satoshi; Yamamoto, Yosuke; Yamazaki, Shin; Fukuhara, Shunichi

2016-11-01

Little is known about the effect of education programs on changing attitudes and behaviors of participants and their families toward deceased organ donation. The subjects of this randomized trial were Japanese nursing students who were not previously designated organ donors. They were randomly assigned to either the education program or information booklet group. The program comprised a lecture followed by group discussion and information booklet. The primary outcome was self-reported organ donor designation. Outcomes were assessed by questionnaire. Data of 203 (99.0%) students were analyzed. At study end, seven of 102 students (6.9%) of the program group and one of 101 students (1.0%) of the booklet group consented to donate organs (proportion ratio 6.93 [95% CI 0.87-55.32]). There were significant between-group differences in willingness to consent for donation (54.9% vs 39.6%; proportion ratio 1.39 [95% CI 1.03-1.87]), family discussion (31.4% vs 15.9%; 1.98 [1.16-3.38]), and organ donor designation of family members (11.8% vs 2.0%; 5.94 [1.36-25.88]). No group differences were found in willingness for organ donation by students and family members. Although there were no significant between-group differences in organ donor designation, the program seems to indirectly promote consent to organ donation by their families. © 2016 The Authors. Clinical Transplantation Published by John Wiley & Sons Ltd.

Trend Analysis of Organ and Tissue Donation for Transplantation.

PubMed

Dos Santos, M J; Leal de Moraes, E; Santini Martins, M; Carlos de Almeida, E; Borges de Barros E Silva, L; Urias, V; Silvano Corrêa Pacheco Furtado, M C; Brito Nunes, Á; El Hage, S

2018-03-01

The goal of this study was to identify the tendency toward donations of tissue and organs from donors with brain death between 2001 and 2016 as registered by an organ procurement organization in São Paulo City. This quantitative, retrospective, exploratory study encompassed all Tissue and Organ Donation Terms signed between 2001 and 2016. A logistic regression model was applied to verify whether there was an upward or downward trend in donation. After statistical analysis, a significant change trend was identified in skin, bones, valve, vessel, heart, lung, and pancreas donations, indicating an increase in the donation rate through the years. The donation rate did not show changes over the years for donations of liver, kidneys, and corneas. The decision-making process regarding organ and tissue donation is restricted not only to the dilemma of whether to donate but another question then arises as well: which organs and tissues are to be donated? The discrepancy between the authorization for organ donation and the authorization for tissue donation, as well as the option for one or another organ and/or tissue, must be thoroughly examined because these factors directly affect the number of transplants and acquirements effectively accomplished. These factors may be related to explaining to one's relatives aspects of the surgery, body reassembling, and usage of such organs and/or tissues. They may also be related to the lack of knowledge concerning organ donation and the symbolism represented by the organ and/or tissue, among other factors. Copyright © 2018 Elsevier Inc. All rights reserved.

Public Opinion on Organ Donation After Death and Its Influence on Attitudes Toward Organ Donation.

PubMed

Aijing, Luo; Wenzhao, Xie; Wei, Wei; Qiquan, Wan; Xuantong, Deng

2016-08-18

BACKGROUND China officially launched a pilot program of organ donation after cardiac death to overcome the shortage of available organs since 2011. Voluntary organ donation by deceased citizens became the only source of transplant organs beginning January 1, 2015. To investigate public opinions on organ donation by deceased donors, and discuss the effect of these opinions on the willingness and attitude of the public regarding voluntary organ donation. MATERIAL AND METHODS We designed a questionnaire. The survey was conducted from December 2014 to January 2015 in Changsha City, and 417 valid questionnaires were recovered. RESULTS A total of 162 respondents explicitly expressed a willingness to donate organs, and 269 believed that the organ donors' relatives should be compensated. A total of 255 respondents thought it acceptable to complete the donation-consent form when receiving a driver's license. Among the respondents, 65.3% did not agree with the statement "My body is bestowed by my parents, and to donate my body parts would not display filial respect"; 88.9% agreed that "It is necessary to consider the willingness of my family"; 74.4% agreed that "Donated organs have not been fairly and appropriately used; the wealthy and celebrities have been favored"; and 61.4% agreed that "Organ donation laws and regulations are not well developed, and organ donations will result in unnecessary difficulties." More than 80% believed that organ donation and transplantation extend life. CONCLUSIONS Public opinions on organ donation after death are associated with various factors, including traditional values, religious beliefs, compensation mechanisms, donor registration, institutional credibility, and ideals.

Can family or replacement blood donors become regular volunteer donors?

PubMed

Asenso-Mensah, Kwame; Achina, Gifty; Appiah, Rita; Owusu-Ofori, Shirley; Allain, Jean-Pierre

2014-03-01

In sub-Saharan Africa (SSA) confirmed viral marker prevalence between family donors (FDs) and first-time volunteer nonremunerated donors (VNRDs) is similar. In a blood service collecting 10 units/1000 inhabitants, a questionnaire examined FD donation conditions and willingness of becoming repeat VNRDs. Four areas were explored: circumstances of visit to hospital, external pressure, experience of donating, and potential repeat donation. After donation and consent, research assistants administered 25 questions and, according to literacy, helped with translation and completion. Of 513 FDs, three-fourths were males (median age, 27 years). Only 1.3% were unemployed and more than 50% were students or teachers. Ties with hospitalized patient were family (76%), friends (13%), colleagues, or sharing place of worship (10%). Donating blood was the reason for visiting in 16.8% and 20.9% had previously donated blood probably as FDs. In one-third of FDs, the family asked for donation of which 10% was pressured by the unjustified reason that not donating was endangering the patient's life. For two-thirds of FDs, donation was given "because individuals were asked." Donation was a positive experience for 77% of donors, 62% being interested in predonation testing. Repeating donation was acceptable for 99% of 79% FDs answering. FDs are active in the population, are willing to donate blood if asked, are submitted to little pressure, do not receive incentives, and accept repeat donation. Except for circumstances of donation, FDs are not different from VNRDs and more directly motivated. They constitute a legitimate and important source to improve the blood supply in SSA. © 2013 American Association of Blood Banks.

The value of area-based analyses of donation patterns for recruitment strategies.

PubMed

James, Adelbert B; Josephson, Cassandra D; Shaz, Beth H; Schreiber, George B; Hillyer, Christopher D; Roback, John D

2014-12-01

Lack of ready access to a donation site may be a potential barrier to or influence the frequency of blood donations. In this study, we applied geographic analysis to blood donor behavior and use of different donation sites. The study population consisted of blood donors who gave whole blood in Georgia between 2004 and 2008. Zip code, city, and county of donor's residence were matched with the addresses of their donation sites. Donors were dichotomized as either nonmetro Atlanta or metro Atlanta residents. Six donation site categories were defined: donation within the same or a different zip code, within the same or a different city, and within the same or a different county. Logistic regression was used to compare donations by zip code, city, and county. The study population consisted of 402,692 blood donors who donated 1,147,442 whole blood units between 2004 and 2008, more than half of whom (56.4%) resided in the metro Atlanta area. The majority of donors were white (75.0%) and female (55.7%). In nonmetro Atlanta, repeat donors were more likely to have donated at fixed sites (p < 0.001). In metro Atlanta, repeat donors were more likely to have donated at a mobile site than at a fixed site (p < 0.001). Geographic and demographic differences in blood donation patterns exist. The locations of donor residences and blood donation sites influence donor behaviors. Understanding the geographic influence on donation patterns provides an important tool for optimizing donor recruitment strategies. © 2014 AABB.

Randomised controlled trials of homeopathy in humans: characterising the research journal literature for systematic review.

PubMed

Mathie, Robert T; Hacke, Daniela; Clausen, Jürgen; Nicolai, Ton; Riley, David S; Fisher, Peter

2013-01-01

A new programme of systematic reviews of randomised controlled trials (RCTs) in homeopathy will distinguish important attributes of RCT records, including: placebo controlled versus other-than-placebo (OTP) controlled; individualised versus non-individualised homeopathy; peer-reviewed (PR) versus non peer-reviewed (NPR) sources. (a) To outline the methods used to search and categorise the RCT literature; (b) to report details of the records retrieved; (c) to compare our retrieved records with those reported in two previous systematic reviews (Linde et al., 1997; Shang et al., 2005). Ten major electronic databases were searched for records published up to the end of 2011. A record was accepted for subsequent systematic review if it was a substantive report of a clinical trial of homeopathic treatment or prophylaxis in humans, randomised and controlled, and published in a PR or NPR journal. 489 records were potentially eligible: 226 were rejected as non-journal, minor or repeat publications, or lacking randomisation and/or controls and/or a 'homeopathic' intervention; 263 (164 PR, 99 NPR) were acceptable for systematic review. The 263 accepted records comprised 217 (137 PR, 80 NPR) placebo-controlled RCTs, of which 121 were included by, 66 were published after, and 30 were potentially eligible for, but not listed by, Linde or Shang. The 137 PR records of placebo-controlled RCTs comprise 41 on individualised homeopathy and 96 on non-individualised homeopathy. Our findings clarify the RCT literature in homeopathy. The 263 accepted journal papers will be the basis for our forthcoming programme of systematic reviews. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

One-stage or two-stage revision surgery for prosthetic hip joint infection--the INFORM trial: a study protocol for a randomised controlled trial.

PubMed

Strange, Simon; Whitehouse, Michael R; Beswick, Andrew D; Board, Tim; Burston, Amanda; Burston, Ben; Carroll, Fran E; Dieppe, Paul; Garfield, Kirsty; Gooberman-Hill, Rachael; Jones, Stephen; Kunutsor, Setor; Lane, Athene; Lenguerrand, Erik; MacGowan, Alasdair; Moore, Andrew; Noble, Sian; Simon, Joanne; Stockley, Ian; Taylor, Adrian H; Toms, Andrew; Webb, Jason; Whittaker, John-Paul; Wilson, Matthew; Wylde, Vikki; Blom, Ashley W

2016-02-17

Periprosthetic joint infection (PJI) affects approximately 1% of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current surgical treatment options are debridement, antibiotics and implant retention; revision THR; excision of the joint and amputation. Revision surgery can be done as either a one-stage or two-stage operation. Both types of surgery are well-established practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient's perspective. The main aim of this randomised controlled trial is to determine whether there is a difference in patient-reported outcome measures 18 months after randomisation for one-stage or two-stage revision surgery. INFORM (INFection ORthopaedic Management) is an open, two-arm, multi-centre, randomised, superiority trial. We aim to randomise 148 patients with eligible PJI of the hip from approximately seven secondary care NHS orthopaedic units from across England and Wales. Patients will be randomised via a web-based system to receive either a one-stage revision or a two-stage revision THR. Blinding is not possible due to the nature of the intervention. All patients will be followed up for 18 months. The primary outcome is the WOMAC Index, which assesses hip pain, function and stiffness, collected by questionnaire at 18 months. Secondary outcomes include the following: cost-effectiveness, complications, re-infection rates, objective hip function assessment and quality of life. A nested qualitative study will explore patients' and surgeons' experiences, including their views about trial participation and randomisation. INFORM is the first ever randomised trial to compare two widely accepted surgical interventions for the treatment of PJI: one-stage and two-stage revision THR. The results of the trial will benefit patients in the future as the main focus is on patient-reported outcomes: pain, function and wellbeing in the long term. Patients state that these outcomes are more important than those that are clinically derived (such as re-infection) and have been commonly used in previous non-randomised studies. Results from the INFORM trial will also benefit clinicians and NHS managers by enabling the comparison of these key interventions in terms of patients' complication rates, health and social resource use and their overall cost-effectiveness. Current controlled trials ISRCTN10956306 (registered on 29 January 2015); UKCRN ID 18159.

Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX).

PubMed

Grant, A M; Cotton, S C; Boachie, C; Ramsay, C R; Krukowski, Z H; Heading, R C; Campbell, M K

2013-04-18

To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD). Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups). Initial recruitment in 21 UK hospitals. Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months. The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care. Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications. By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), P<0.001, at five years). SF-36 and EQ-5D scores also favoured surgery, but were not statistically significant at five years. After fundoplication, 3% (12/364) had surgical treatment for a complication and 4% (16) had subsequent reflux-related operations-most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups. After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse symptoms caused by surgery. Current Controlled Trials ISRCTN15517081.

What weighs more-low compliance with self-deferral or minor medical procedures? Explaining the high rate of hepatitis C virus window-period donations in Poland.

PubMed

Czerwinski, Michal; Grabarczyk, Piotr; Stepien, Malgorzata; Kubicka-Russel, Dorota; Tkaczuk, Katarzyna; Brojer, Ewa; Rosinska, Magdalena

2017-08-01

Since the introduction of nucleic acid testing (NAT) for routine blood donor screening, hepatitis C virus (HCV) RNA-only detection rates reported from Poland have been higher than in most other European countries. To examine factors that likely contribute to these window-period donations, we conducted a case-control study among 47 recently HCV-infected blood donors (cases), who gave blood between July 2002 and June 2014, and 141 controls matched by age, sex, and donation dates. Firth-corrected, conditional logistic regression models were fitted to estimate adjusted odds ratios and 95% confidence intervals. Adjusted population-attributable fractions were calculated based on the distribution of exposure among the cases. On multivariate analysis, recent exposures in health care environments not routinely ascertained through predonation questionnaires were strongly associated with recently acquired HCV infection. These exposures included minor medical and dental procedures in the preceding 6 months (adjusted odds ratio, 5.77; 95 % confidence interval, 2.01-18.53). However, based on the population-attributable fraction, more important were behavioral deferrable risks that went unreported at the time of donation, such as high-risk sexual behaviors in the preceding 6 months (population-attributable fraction, 34%) or lifetime histories of drug use (population-attributable fraction, 28%). This study raises questions about the effectiveness of deferral policy in excluding high-risk individuals. In addition, it provides further evidence supporting short, temporal deferrals for small medical procedures and dental treatments in Poland. © 2017 AABB.

Adjunctive rifampicin to reduce early mortality from Staphylococcus aureus bacteraemia (ARREST): study protocol for a randomised controlled trial

PubMed Central

2012-01-01

Background Staphylococcus aureus bacteraemia is a common and serious infection, with an associated mortality of ~25%. Once in the blood, S. aureus can disseminate to infect almost any organ, but bones, joints and heart valves are most frequently affected. Despite the infection’s severity, the evidence guiding optimal antibiotic therapy is weak: fewer than 1,500 patients have been included in 16 randomised controlled trials investigating S. aureus bacteraemia treatment. It is uncertain which antibiotics are most effective, their route of administration and duration, and whether antibiotic combinations are better than single agents. We hypothesise that adjunctive rifampicin, given in combination with a standard first-line antibiotic, will enhance killing of S. aureus early in the treatment course, sterilise infected foci and blood faster, and thereby reduce the risk of dissemination, metastatic infection and death. Our aim is to determine whether adjunctive rifampicin reduces all-cause mortality within 14 days and bacteriological failure or death within 12 weeks from randomisation. Methods We will perform a parallel group, randomised (1:1), blinded, placebo-controlled trial in NHS hospitals across the UK. Adults (≥18 years) with S. aureus (meticillin-susceptible or resistant) grown from at least one blood culture who have received ≤96 h of active antibiotic therapy for the current infection and do not have contraindications to the use of rifampicin will be eligible for inclusion. Participants will be randomised to adjunctive rifampicin (600-900mg/day; orally or intravenously) or placebo for the first 14 days of therapy in combination with standard single-agent antibiotic therapy. The co-primary outcome measures will be all-cause mortality up to 14 days from randomisation and bacteriological failure/death (all-cause) up to 12 weeks from randomisation. 940 patients will be recruited, providing >80% power to detect 45% and 30% reductions in the two co-primary endpoints of death by 14 days and bacteriological failure/death by 12 weeks respectively. Discussion This pragmatic trial addresses the long-standing hypothesis that adjunctive rifampicin improves outcome from S. aureus bacteraemia through enhanced early bacterial killing. If proven correct, it will provide a paradigm through which further improvements in outcome from S. aureus bacteraemia can be explored. Trial registration Current Controlled Trial ISRCTN 37666216 PMID:23249501

Evaluation of a novel information resource for patients with bronchiectasis: study protocol for a randomised controlled trial.

PubMed

Hester, Katy L M; Newton, Julia; Rapley, Tim; De Soyza, Anthony

2016-04-23

There is currently little patient information on bronchiectasis, a chronic lung disease with rising prevalence. Previous work shows that patients and their families want more information, which could potentially improve their understanding and self-management. Using interviews and focus groups, we have co-developed a novel patient and carer information resource, aiming to meet their identified needs. The aims and objectives are: 1. To assess the potential impact of the information resource 2. To evaluate and refine the intervention 3. To establish the feasibility of carrying out a multi-centre randomised controlled trial to determine its effect on understanding, self-management and health outcomes This is a feasibility study, with a single-centre, randomised controlled trial design, comparing use of a novel patient information resource to usual care in bronchiectasis. Additionally, patients and carers will be invited to focus groups to discuss their views on both the intervention itself and the trial process. The study duration for each participant will be 3 months from the study entry date. A total of 70 patients will be recruited to the study, and a minimum of 30 will be randomised to each arm. Ten participants (and their carers if applicable) will be invited to attend focus groups on completion of the study visits. Participants will be adults with bronchiectasis diagnosed as per national bronchiectasis guidelines. Once consented, participants will be randomised to the intervention or control arm using random permuted blocks to ensure treatment group numbers are evenly balanced. Randomisation will be web-based. Those randomised to the intervention will receive the information resource (website and booklet) and instructions on its use. Outcome measures (resource satisfaction, resource use and alternative information seeking, quality of life questionnaires, unscheduled healthcare visits, exacerbation frequency, bronchiectasis knowledge questionnaire and lung function tests) will be recorded at baseline, 2 weeks and 3 months. All outcome measures will be used in assessing feasibility and acceptability of a future definitive trial. Feasibility outcomes include recruitment, retention and study scale form completion rates. Focus groups will strengthen qualitative data for resource refinement and to identify participant views on the trial process, which will also inform feasibility assessments. Questionnaires will also be used to evaluate and refine the resource. ISRCTN84229105.

Can exercise improve self esteem in children and young people? A systematic review of randomised controlled trials.

PubMed

Ekeland, E; Heian, F; Hagen, K B

2005-11-01

A systematic review to determine if exercise alone or as part of a comprehensive intervention can improve self esteem in children and young people is described. Twenty three randomised controlled trials were analysed. A synthesis of several small, low quality trials indicates that exercise may have short term beneficial effects on self esteem in children and adolescents. However, high quality research on defined populations with adequate follow up is needed.

48 CFR 45.603 - Abandonment, destruction or donation of excess personal property.

Code of Federal Regulations, 2010 CFR

2010-10-01

... or donation of excess personal property. 45.603 Section 45.603 Federal Acquisition Regulations System... Disposal 45.603 Abandonment, destruction or donation of excess personal property. (a) Plant clearance... any of the costs incident to a donation. (d)(1) Before abandoning, destroying, or donating excess...

23 CFR 710.505 - Real property donations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Real property donations. 710.505 Section 710.505...-WAY AND REAL ESTATE Property Acquisition Alternatives § 710.505 Real property donations. (a) Donations..., whichever is greater. All donations of property received prior to the approval of the NEPA document must...

48 CFR 45.604-2 - Abandonment, destruction, or donation of surplus property.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., or donation of surplus property. 45.604-2 Section 45.604-2 Federal Acquisition Regulations System... Disposal 45.604-2 Abandonment, destruction, or donation of surplus property. (a) Plant clearance officers... the costs incident to donation. (d) Before abandoning, destroying, or donating surplus property, the...

32 CFR 553.6 - Donations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Donations. 553.6 Section 553.6 National Defense... NATIONAL CEMETERIES § 553.6 Donations. (a) Policy. Under Department of the Army policy, proffered donations... for the donation or gift. (2) Delivery is made to the cemetery or to another point designated by the...

41 CFR 101-42.304 - Special requirements for donation of certain hazardous materials.

Code of Federal Regulations, 2010 CFR

2010-07-01

... donation of certain hazardous materials. 101-42.304 Section 101-42.304 Public Contracts and Property....3-Donation of Hazardous Materials and Certain Categories of Property § 101-42.304 Special requirements for donation of certain hazardous materials. Special donation requirements for specific hazardous...

41 CFR 101-42.304 - Special requirements for donation of certain hazardous materials.

Code of Federal Regulations, 2012 CFR

2012-07-01

... donation of certain hazardous materials. 101-42.304 Section 101-42.304 Public Contracts and Property....3-Donation of Hazardous Materials and Certain Categories of Property § 101-42.304 Special requirements for donation of certain hazardous materials. Special donation requirements for specific hazardous...

48 CFR 45.603 - Abandonment, destruction or donation of excess personal property.

Code of Federal Regulations, 2011 CFR

2011-10-01

... or donation of excess personal property. 45.603 Section 45.603 Federal Acquisition Regulations System... Disposal 45.603 Abandonment, destruction or donation of excess personal property. (a) Plant clearance... any of the costs incident to a donation. (d)(1) Before abandoning, destroying, or donating excess...

41 CFR 101-42.304 - Special requirements for donation of certain hazardous materials.

Code of Federal Regulations, 2013 CFR

2013-07-01

... donation of certain hazardous materials. 101-42.304 Section 101-42.304 Public Contracts and Property....3-Donation of Hazardous Materials and Certain Categories of Property § 101-42.304 Special requirements for donation of certain hazardous materials. Special donation requirements for specific hazardous...

32 CFR 553.6 - Donations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 3 2011-07-01 2009-07-01 true Donations. 553.6 Section 553.6 National Defense... NATIONAL CEMETERIES § 553.6 Donations. (a) Policy. Under Department of the Army policy, proffered donations... for the donation or gift. (2) Delivery is made to the cemetery or to another point designated by the...

2 CFR 200.434 - Contributions and donations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Contributions and donations. 200.434 Section... Cost § 200.434 Contributions and donations. (a) Costs of contributions and donations, including cash... space is not reimbursable either as a direct or indirect cost. (2) The value of the donations may be...

48 CFR 45.604-2 - Abandonment, destruction, or donation of surplus property.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., or donation of surplus property. 45.604-2 Section 45.604-2 Federal Acquisition Regulations System... Disposal 45.604-2 Abandonment, destruction, or donation of surplus property. (a) Plant clearance officers... the costs incident to donation. (d) Before abandoning, destroying, or donating surplus property, the...

41 CFR 101-42.304 - Special requirements for donation of certain hazardous materials.

Code of Federal Regulations, 2014 CFR

2014-07-01

... donation of certain hazardous materials. 101-42.304 Section 101-42.304 Public Contracts and Property....3-Donation of Hazardous Materials and Certain Categories of Property § 101-42.304 Special requirements for donation of certain hazardous materials. Special donation requirements for specific hazardous...

32 CFR 553.6 - Donations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 3 2013-07-01 2013-07-01 false Donations. 553.6 Section 553.6 National Defense... NATIONAL CEMETERIES § 553.6 Donations. (a) Policy. Under Department of the Army policy, proffered donations... for the donation or gift. (2) Delivery is made to the cemetery or to another point designated by the...

32 CFR 553.6 - Donations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 3 2012-07-01 2009-07-01 true Donations. 553.6 Section 553.6 National Defense... NATIONAL CEMETERIES § 553.6 Donations. (a) Policy. Under Department of the Army policy, proffered donations... for the donation or gift. (2) Delivery is made to the cemetery or to another point designated by the...

41 CFR 101-42.304 - Special requirements for donation of certain hazardous materials.

Code of Federal Regulations, 2011 CFR

2011-07-01

... donation of certain hazardous materials. 101-42.304 Section 101-42.304 Public Contracts and Property....3-Donation of Hazardous Materials and Certain Categories of Property § 101-42.304 Special requirements for donation of certain hazardous materials. Special donation requirements for specific hazardous...

Understanding the pros and cons of organ donation decision-making: Decisional balance and expressing donation intentions among African Americans.

PubMed

Flemming, Shauna St Clair; Redmond, Nakeva; Williamson, Dana Hz; Thompson, Nancy J; Perryman, Jennie P; Patzer, Rachel E; Arriola, Kimberly Jacob

2018-04-01

Increasing public commitment to organ donation is critical to improving donor kidney availability for end-stage renal disease patients desiring transplant. This study surveyed ( N = 1339) African Americans, measuring perceived pros relative to cons of organ donation, to evaluate an existing Transtheoretical Model decisional balance scale and associations between decisional balance and expressing donation intentions. Findings supported the existing scale structure. More positive decisional balance ratios were associated with 1.76 times the odds of expressing intentions (95% confidence interval = 1.52-2.04). Pros were more strongly linked to donation intentions than cons. Greater understanding of organ donation decision-making is valuable for informing interventions that encourage donation.

The challenges of social marketing of organ donation: news and entertainment coverage of donation and transplantation.

PubMed

Harrison, Tyler R; Morgan, Susan E; Chewning, Lisa V

2008-01-01

While great strides have been made in persuading the public to become potential organ donors, actual behavior has not yet caught up with the nearly universally favorable attitudes the public expresses toward donation. This paper explores the issue by situating the social marketing of organ donation against a broader backdrop of entertainment and news media coverage of organ donation. Organ donation storylines are featured on broadcast television in medical and legal dramas, soap operas, and other television serials approximately four times per month (not including most cable networks), and feature storylines that promote myths and fears of the organ donation process. National news and other non-fictionalized coverage of organ donation are even more common, with stories appearing over twenty times a month on average. These stories tend to be one-dimensional and highly sensationalized in their coverage. The marketing of organ donation for entertainment essentially creates a counter-campaign to organ donation, with greater resources and reach than social marketers have access to. Understanding the broader environmental context of organ donation messages highlights the issues faced by social marketing campaigns in persuading the public to become potential donors.

Knowledge and practice of blood donation: a comparison between medical and non-medical Nepalese students.

PubMed

Mamatya, A; Prajapati, R; Yadav, R

2012-12-01

College students form a large and important group of population eligible for blood donation. Studies report that students do not donate much, and medical students' blood donation rate is less as compared to non-medical students. To assess and compare the knowledge, attitude, and practice of blood donation among medical and non-medical Nepalese students. A cross-sectional descriptive study using structured self-administered questionnaire was conducted in students of medical (MBBS) and non-medical programs of different colleges of Nepal. Total 456 students, 177 non-medical and 279 medical, participated; 28.5% students were donors. More medical students donated blood, more often, and were more knowledgeable in all aspects of blood and blood donation related knowledge (p values 0.01 or less). In both groups, proportionately more boys donated than girls. Common reasons for not donating included no request, medically unfit, no information about blood collection services, fear of weakness, and fear related to venepuncture. Moral satisfaction was the commonest reason to donate. Among Nepalese students, medical students donate more and are more knowledgeable than non-medical students. Lack of information and lack of direct requests are important causes of fewer donors in the non-medical group and girls.

Awareness about organ donation especially kidney donation in Nurpur Shahan, a rural community area in Islamabad, Pakistan.

PubMed

Maroof, Sana; Kiyani, Nimrah; Zaman, Zahra; Gul, Raisa Khan; Nayyar, Sarah; Azmat, Ayesha; Anwar, Nageen; Shah, Rahim; Iqbal, Saima; Junaid, Aliya

2011-08-01

To assess the level of awareness and ethical issues related to organ donation especially kidney donation and the willingness to donate a kidney among the rural population of Pakistan. A cross sectional study was conducted in a sample of 324 subjects residing in Nurpur Shahan by means of a pre tested questionnaire. Data collection was carried out via a face to face interview and the data was analyzed using SPSS 10.0 and associations were tested using the Chi-square test. Knowledge about organ donation was significantly associated with age (p = 0.00) and education (p = 0.024). Allowance of organ donation in religion was an important factor in determining the attitude of individuals towards organ donation and their willingness to donate. Media emerged as a major source of information for the population of Nurpur Shahan; kidney was the organ most known for its donation. Most (69%) respondents did not consider organ vending to be ethically correct but a sizeable proportion (25%) thought it may be considered in times of dire need. Awareness of organ donation in our sample was high and more than half of the people were willing to become donors.

The rates, perceptions, and willingness of men who have sex with men to donate blood.

PubMed

Liszewski, Walter; Becerril, Jordan; Terndrup, Christopher; West, Nathan; Lavin, Bridget C; Schieffler, Danny; Van Sickels, Nicholas

2014-07-01

Since 1983 in the United States, any man who has had sex with another man (MSM) at any time since 1977 has been deferred from donating blood for life. Although there has been a push to change the deferral, there is a paucity of information on both the rates of MSM blood donation and the willingness of MSMs to donate if the deferral were changed. A 15-question survey was given at two lesbian, gay, bisexual, and transgender festivals in Chicago and New Orleans. Participants were asked about a previous history of blood donation and whether they would be willing to donate were the lifetime deferral changed. Participants were also asked to determine whether it was safe for hypothetical MSMs with varying sexual practices to donate blood and whether they believed that it was safe for them to donate their own blood. Our study found that 42.0% of all participants had not complied with the deferral policy and have donated blood at least once, with a mean number of donations of 4.84. Additionally, 85.9% of participants would be willing to donate blood if the deferral were changed. Despite the lifetime deferral, many MSMs have previously donated blood, and many more are willing to donate. Given this, along with the safe implementation of temporary deferral policies in other nations, the United States should consider adopting a temporary deferral policy for MSMs. © 2014 AABB.

Investigation and Strategic Analysis of Public Willingness and Attitudes Toward Organ Donation in East China.

PubMed

Zhang, H; Zheng, J; Liu, W; Ding, J; Zhang, L; Zhang, H; Zou, Y; Fu, Y

2015-10-01

China officially initiated deceased organ donation in 2010. Much progress has been made since then. However, compared with the developed countries in Europe and America, there is still a large gap. In this study, we investigate the willingness and attitude of the general public in East China and the factors that affect organ donation, and propose specific recommendations for promoting it. A simple and random sample was questioned. The data were analyzed statistically using SPSS 19.0 software, χ(2) test, and logistic regression. A total of 1200 questionnaires were issued; of these, 1105 were recovered, with 1074 effective questionnaires, for an effective rate of 89.5%. Among these, 426 respondents (39.7%) were willing to donate, 529 (49.3%) were in favor of donation but would not donate themselves; and 119 (11.1%) were against donation. Women (P < .01), persons with higher education (P < .01), those who understand organ donation (P < .01), and those who accept the concept of brain death (P < .01) had higher degrees of acceptance for organ donation. Reasons to hinder organ donation included imperfect laws and regulations, distrust on organ allocation, and insufficient promotion by relevant organizations. Much needs to be done to promote organ donation in China; targeted publicity will help to improve the work efficiency of organ donation; improvement of relevant policies and regulations, and establishment of a fair and transparent organ allocation system are key to the development of organ donation. Copyright © 2015 Elsevier Inc. All rights reserved.

Inappropriate drug donations: what has happened since the 1999 WHO guidelines?

PubMed

van Dijk, D P; Dinant, G; Jacobs, J A

2011-08-01

Drug donations to developing countries may be part of medical relief operations in acute emergencies, development aid in non-emergency situations, or a corporate donations programme. After a number of documented inappropriate drug donations, the World Health Organization developed the 'Guidelines for Drug Donations', with the second and final version published in 1999. We reviewed the medical literature on drug donations since the Guidelines publication in 1999. Literature was retrieved from PubMed and other on-line databases as well as from relevant websites providing medical literature for use in developing countries. We considered the following donations to be inappropriate: (i) essential drugs in excessive quantities; (ii) mixed unused drugs (unsorted medicines and free samples); and (iii) drug dumping (large quantities of useless medicines). We retrieved 25 publications dated after 1999, including 20 and 5 from the scientific literature and 'grey' literature (technical reports, working papers), respectively. New information concerned emergencies in East Timor, Mozambique, El Salvador, Gujarat State (India), Aceh (Indonesia) and Sri Lanka. Except for East Timor and Gujarat, inappropriate donations still occurred, accounting for 85%, 37%, 70% and 80% of donations in Mozambique, El Salvador, Aceh and Sri Lanka, respectively. Very little information was found on drug donations in non-emergency situations. There are few recent reports on the compliance of drug donations with the World Health Organization guidelines. For emergency situations, there is still room for improvement. Drug donations in non-emergency situations need to be evaluated. A reform of drug donations policy is needed.

Knowledge, attitude, and practice regarding voluntary blood donation among adult residents of Harar town, Eastern Ethiopia: a community-based study

PubMed Central

Urgesa, Kedir; Hassen, Nejat; Seyoum, Ayichew

2017-01-01

Background The availability of safe blood and blood products is a critical factor in improving health care. In Ethiopia, lack of voluntary blood donors is a major challenge. This could be due to low community knowledge, unfavorable attitude, and poor donation practice regarding voluntary blood donation. Thus, the aim of this study was to assess community knowledge, attitude, and practice regarding voluntary blood donation among adults in Harar town, Ethiopia. Materials and methods A community-based cross-sectional study was conducted from July 1 to July 31, 2015. A total of 845 adults were randomly selected and interviewed using a pretested, structured questionnaire. Six trained data collectors conducted a face-to-face interview. Data were entered into EpiData Version 3 and analyzed using STATA Version 11. Results Comprehensive knowledge of the study participants toward voluntary blood donation was 43.5%. Multivariable logistic regression demonstrated that male sex (adjusted odds ratio [AOR] = 1.69, 95% confidence interval [CI]: 1.19–2.39), age (31–45 years; AOR = 0.50, 95% CI: 0.34–0.74) and >45 years (AOR = 0.60, 95% CI: 0.38–0.95), and higher education (AOR = 15.34, 95% CI: 5.01–46.91) were significantly associated with comprehensive knowledge about voluntary blood donation. A total of 278 (32.9%) study participants had positive attitude toward voluntary blood donation. College graduates (AOR = 13.05, 95% CI: 4.12–41.29) were significantly associated with positive attitude toward voluntary blood donation. Only 191 (22.6%) subjects had ever donated blood. However, the proportion of study participants who donated blood voluntarily with good knowledge about voluntary blood donation was significantly lower than the study participants who donated blood voluntarily with low knowledge (X2 = 6.1746, P = 0.013). Conclusion This study showed an inauspicious attitude toward blood donation and poor blood donation practices. Subjects with good comprehensive knowledge about voluntary blood donation were less likely to donate blood voluntarily compared to those with lower comprehensive knowledge about voluntary blood donation. PMID:28243159

Knowledge, attitude, and practice regarding voluntary blood donation among adult residents of Harar town, Eastern Ethiopia: a community-based study.

PubMed

Urgesa, Kedir; Hassen, Nejat; Seyoum, Ayichew

2017-01-01

The availability of safe blood and blood products is a critical factor in improving health care. In Ethiopia, lack of voluntary blood donors is a major challenge. This could be due to low community knowledge, unfavorable attitude, and poor donation practice regarding voluntary blood donation. Thus, the aim of this study was to assess community knowledge, attitude, and practice regarding voluntary blood donation among adults in Harar town, Ethiopia. A community-based cross-sectional study was conducted from July 1 to July 31, 2015. A total of 845 adults were randomly selected and interviewed using a pretested, structured questionnaire. Six trained data collectors conducted a face-to-face interview. Data were entered into EpiData Version 3 and analyzed using STATA Version 11. Comprehensive knowledge of the study participants toward voluntary blood donation was 43.5%. Multivariable logistic regression demonstrated that male sex (adjusted odds ratio [AOR] = 1.69, 95% confidence interval [CI]: 1.19-2.39), age (31-45 years; AOR = 0.50, 95% CI: 0.34-0.74) and >45 years (AOR = 0.60, 95% CI: 0.38-0.95), and higher education (AOR = 15.34, 95% CI: 5.01-46.91) were significantly associated with comprehensive knowledge about voluntary blood donation. A total of 278 (32.9%) study participants had positive attitude toward voluntary blood donation. College graduates (AOR = 13.05, 95% CI: 4.12-41.29) were significantly associated with positive attitude toward voluntary blood donation. Only 191 (22.6%) subjects had ever donated blood. However, the proportion of study participants who donated blood voluntarily with good knowledge about voluntary blood donation was significantly lower than the study participants who donated blood voluntarily with low knowledge ( X 2 = 6.1746, P = 0.013). This study showed an inauspicious attitude toward blood donation and poor blood donation practices. Subjects with good comprehensive knowledge about voluntary blood donation were less likely to donate blood voluntarily compared to those with lower comprehensive knowledge about voluntary blood donation.

Does organ donation legislation affect individuals' willingness to donate their own or their relative's organs? Evidence from European Union survey data.

PubMed

Mossialos, Elias; Costa-Font, Joan; Rudisill, Caroline

2008-02-27

Maintaining adequately high organ donation rates proves essential to offering patients all appropriate and available treatment options. However, the act of donation is in itself an individual decision that requires a depth of understanding that interacts with the social setting and the institutional framework into which an individual is embedded. This study contributes to understanding factors driving organ donation rates by examining how country regulation, individuals' awareness of regulatory setting, social interactions and socio-demographic determinants influence individuals' willingness to donate their own organs or those of a relative. We draw representative data from the Eurobarometer survey 58.2 undertaken in 2002 with respondents throughout the European Union to capture heterogeneity in institutional setting. We use logistic regression techniques to estimate the determinants of willingness to donate one's own organs and those of a deceased relative. We employ interaction terms to examine the relationship between institutional setting and respondent's awareness of organ donation legislation in their country. Our findings indicate that individuals are more likely to donate their organs than to consent to the donation of a relative's organs. Both decisions are affected by regulation (presumed consent), awareness of regulation and social interactions such as the ability to count on others in case of a serious problem (reciprocity). Furthermore, education (more educated), age (younger), expressing some sort of political affiliation determine willingness to donate one's own organs and consent to the donation of those of a relative. This study confirms and develops further previous research findings that presumed consent organ donation policy positively affects the willingness of individuals to donate their own organs and those of relative by highlighting the importance of awareness of this regulation and an individual's level of social interactions in making choices about donation. Results found using interaction terms underline the importance of population awareness of organ donation legislation as well as the legislation type itself. Findings also point to the role of social interactions in influencing individuals' willingness to donate their organs or those of a relative.

Ambulatory versus inpatient management of severe nausea and vomiting of pregnancy: a randomised control trial with patient preference arm

PubMed Central

Mitchell-Jones, Nicola; Farren, Jessica Alice; Tobias, Aurelio; Bourne, Tom; Bottomley, Cecilia

2017-01-01

Objective To determine whether ambulatory (outpatient (OP)) treatment of severe nausea and vomiting of pregnancy (NVP) is as effective as inpatient (IP) care. Design Non-blinded randomised control trial (RCT) with patient preference arm. Setting Two multicentre teaching hospitals in London. Participants Women less than 20 weeks’ pregnant with severe NVP and associated ketonuria (>1+). Methods Women who agreed to the RCT were randomised via web-based application to either ambulatory or IP treatment. Women who declined randomisation underwent the treatment of their choice in the patient preference trial (PPT) arm. Treatment protocols, data collection and follow-up were the same for all participants. Main outcome measures Primary outcome was reduction in Pregnancy Unique Quantification of Emesis (PUQE) score 48 hours after starting treatment. Secondary outcome measures were duration of treatment, improvement in symptom scores and ketonuria at 48 hours, reattendances within 7 days of discharge and comparison of symptoms at 7 days postdischarge. Results 152/174 eligible women agreed to participate with 77/152 (51%) recruited to the RCT and 75/152 (49%) to the PPT. Patients were initially compared in four groups (randomised IP, randomised OP, non-randomised IP and non-randomised OP). Comprehensive cohort analysis of participants in the randomised group (RCT) and non-randomised group (PPT) did not demonstrate any differences in patient demographics or baseline clinical characteristics. Pooled analysis of IP versus OP groups showed no difference in reduction in PUQE score at 48 hours (p=0.86). There was no difference in change in eating score (p=0.69), drinking score (p=0.77), well-being rating (p=0.64) or reduction in ketonuria (p=0.47) at 48 hours, with no difference in duration of index treatment episode (p=0.83) or reattendances within 7 days (p=0.52). Conclusions Ambulatory management is an effective direct alternative to IP management of severe NVP. The trial also demonstrated that many women requiring treatment for severe NVP have strong preferences regarding treatment setting, which may need to be considered by care providers, especially given the psychological impact of severe NVP. Trial registration number http://www.isrctn.com/ISRCTN24659467 (March 2014). PMID:29222135

Can evidence-based health policy from high-income countries be applied to lower-income countries: considering barriers and facilitators to an organ donor registry in Mumbai, India.

PubMed

Vania, Diana K; Randall, Glen E

2016-01-13

Organ transplantation has become an effective means to extend lives; however, a major obstacle is the lack of availability of cadaveric organs. India has one of the lowest cadaver organ donation rates in the world. If India could increase the donor rate, the demand for many organs could be met. Evidence from high-income countries suggests that an organ donor registry can be a valuable tool for increasing donor rates. The purpose of this study is to determine whether the implementation of an organ donor registry is a feasible and appropriate policy option to enhance cadaver organ donation rates in a lower-income country. This qualitative policy analysis employs semi-structured interviews with physicians, transplant coordinators, and representatives of organ donation advocacy groups in Mumbai. Interviews were designed to better understand current organ donation procedures and explore key informants' perceptions about Indian government health priorities and the likelihood of an organ donor registry in Mumbai. The 3-i framework (ideas, interests, and institutions) is used to examine how government decisions surrounding organ donation policies are shaped. Findings indicate that organ donation in India is a complex issue due to low public awareness, misperceptions of religious doctrines, the need for family consent, and a nation-wide focus on disease control. Key informants cite social, political, and infrastructural barriers to the implementation of an organ donor registry, including widely held myths about organ donation, competing health priorities, and limited hospital infrastructure. At present, both the central government and Maharashtra state government struggle to balance international pressures to improve overall population health with the desire to also enhance individual health. Implementing an organ donor registry in Mumbai is not a feasible or appropriate policy option in India's current political and social environment, as the barriers, identified through the 3-i framework lens, may be too difficult to overcome. Despite the evidence supporting the use of donor registries as a means to enhance organ donation rates, it is clear that context is critical and that it is not always practical to apply evidence-based policy solutions from high-income countries to lower-income settings.

Organ and tissue donation in a regional paediatric intensive care unit: evaluation of practice.

PubMed

Carone, Laura; Alurkar, Shrirang; Kigozi, Phoebe; Vyas, Harish

2018-05-01

Approximately 2% of those on the organ transplant list in the UK are children. Early identification of donors and referral to organ donation teams (ODT) has proven to increase both the success rate of gaining consent and the number of organs actually retrieved. To evaluate the practice relating to organ donation for children receiving end-of-life care on a paediatric intensive care unit (PICU) measured against the National Guidelines. All children 0-18 who received their end-of-life care and died on the PICU. A retrospective cohort study of organ donation patterns including referral, approach, consent and donation. This involved a review of case notes on PICU between the years 2009 and 2014. One hundred five deaths were identified and 100 notes were examined and data analysed to ascertain if religion, age and length of stay on PICU impacted on practice. Eighty-six children met the early identification criteria for potential donors, 40 (46.5%) children were referred to the ODT and 33 (38.3%) families were approached regarding donation. Twenty-one (24.4%) families consented to donation. Seventeen donations took place with a total of 41 sets of organs/tissues retrieved. Despite the majority of children meeting early identification for potential donors, many were not being referred. All children on end-of-life care should be referred for potential organ donation. Organ donation needs to be seen as a priority for hospitals as a part of routine end-of-life care to help increase referral rates and give families the opportunity to donate. Many paediatric deaths are not referred for consideration of organ donation, despite guidelines stating that this process should be standard of care. Further optimization of referral rates may aid in increasing the number of organs available for donation. What is Known: • Shortage of organs continues to be a national problem. • NICE guidelines state that all patients who are on end-of-life care should have the option of organ donation explored. • Required referral both increases the number of donors and organs donated. What is New: • The process of identifying and referring children for paediatric organ donation. • Identifies that children are still not being referred for organ donation. • Organ donation is still not a priority for hospitals.

Knowledge of Kidney Donation Among Care Givers in Two Tertiary Hospitals in Southwest Nigeria.

PubMed

Adejumo, Oluseyi A; Solarin, Adaobi U; Abiodun, Moses T; Akinbodewa, Ayodeji A

2017-05-01

One of the major challenges of kidney transplantation is shortage of kidney donors. Care givers (CGs) are potential kidney donors, but the majority of them are unwilling to donate due to inadequate knowledge on kidney donation. This study evaluated the knowledge of kidney donation and its determinants among CGs in two tertiary hospitals in Southwest Nigeria. This was a cross-sectional study that was carried out in the Kidney Care Centre (KCC), Ondo and Babcock University Teaching Hospital (BUTH), Ilishan-Remo using a self-administered pretested questionnaire that assessed knowledge of kidney donation and its determinants. Pvalue of <0.05 was taken as significant. A total of 244 respondents participated in the study. The majority were below 40 years, married, and female. The proportion of respondents with adequate knowledge of kidney donation was 63.4%. More respondents from BUTH compared to KCC had adequate knowledge of kidney donation (80% vs. 46.7%, P ≤ 0.001). Similarly, the mean knowledge score was higher in respondents from BUTH (P ≤ 0.001). Factors that determined knowledge of kidney donation were female gender (AOR: 3.43, 95% CI: 1.25-9.40, P = 0.02) and social class (AOR: 1.22, 95% CI: 0.50-2.95, P ≤ 0.001). There was positive correlation between knowledge of kidney donation among the respondents from both hospitals and their willingness to donate kidneys (r = 0.439, P ≤ 0.001). Knowledge of kidney donation was better among BUTH's respondents. Gender and social class were predictors of knowledge of kidney donation. Improving knowledge of kidney donation may improve willingness to donate among the public. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Attitude and awareness towards organ donation in western India.

PubMed

Balwani, Manish R; Gumber, Manoj R; Shah, Pankaj R; Kute, Vivek B; Patel, Himanshu V; Engineer, Divyesh P; Gera, Dinesh N; Godhani, Umesh; Shah, Mehin; Trivedi, Hargovind L

2015-05-01

To determine the knowledge, attitudes and practices regarding organ donation in western India. Convenience sampling was used to generate a sample of 250; 200 interviews were successfully completed and used for analysis. Data collection was carried out via face to face interviews based on a pre-tested questionnaire in selected public areas of Ahmedabad, Gujarat state of India. Data entry was made in excel software in codes and analysis was done by SPSS software. About 86% of participants were aware of the term organ donation but knowledge about its various aspects was low. About 48% aware people heard about organ donation through medical fraternity, whereas only about 21% became aware through mass media. About 59% of aware people believed there is a potential danger of donated organs being misused, abused or misappropriated. About 47% of aware people said they would consider donating organs, while only 16% said they would definitely donate irrespective of circumstances. Around 97.67% participants said they would prefer to donate to nonsmokers. About 74.41% participants were unaware about any legislation regarding organ donation. About 77% participants showed their will to donate to mentally sound persons, and 42.04% participants showed their will to donate even physically challenged people. Around 78 participants felt that they would donate organs to persons irrespective of their religion. About 81% of aware people were of the opinion that consent for organ donation after death should be given by family members. None of the interviewed participants had a donor card. Better knowledge and awareness will help in promoting organ donation. Effective campaign needs to be driven to educate people with relevant information with the involvement of media, doctors and religious scholars.

Intention of donors to re-donate livers after living donor liver transplantation in a liver transplant center in Asia.

PubMed

Chang, Yuan-Min; Chung, Kuo-Piao; Chen, Teng-Wei; Hsieh, Chung-Bao

2014-08-25

The aim of this study was to examine donor complications, satisfaction with the liver donation process, and factors associated with re-donation. To address these issues, we conducted a cross-sectional study to assess donor complications and used questionnaires (including the Likert scale for donation satisfaction and simple yes/no responses for willingness to re-donate) in 110 adults who underwent living donor liver transplantation (LDLT) at Tri-Service General Hospital. The following clinical characteristics were determined: donation volume; first-degree relative; education; duration of hospital stay; occupation (donor-associated); MELD score; Child classification; complications; outcome (recipient-associated); and graft/recipient weight ratio (donor-recipient-associated). Descriptive statistics and mean values were compared using t-tests and p values <0.05 were considered significant. Twelve donors among 110 participants experienced complications above Clavien grade II. No surgical mortalities were observed. There were no differences in age, gender, left/right liver graft, donation volume, length of hospital stay, or satisfaction in donor complications. Ninety-four donors had satisfaction (score=4 and 5) about the donation process and no dissatisfaction was reported (score=1). Based on multivariate analysis, the intention to re-donate among liver donors was related to first-degree relatives, donor satisfaction, and recipient complications (P<0.05). Factors associated with a willingness to re-donate included first-degree relatives of the recipient, donor satisfaction with the donation process, and recipient complications. This study not only showed the safety of liver donation, but also had a positive effect on the intention to re-donate to enhance motivation for liver donation and increase the recruitment of living liver donors.

Factors Associated With Medical and Nursing Students' Willingness to Donate Organs.

PubMed

Tumin, Makmor; Tafran, Khaled; Tang, Li Yoong; Chong, Mei Chan; Mohd Jaafar, Noor Ismawati; Mohd Satar, NurulHuda; Abdullah, Nurhidayah

2016-03-01

Malaysia suffers from a chronic shortage of human organs for transplantation. Medical and nursing students (MaNS) are future health professionals and thus their attitude toward organ donation is vital for driving national donation rates. This study investigates MaNS' willingness to donate organs upon death and the factors influencing their willingness. A cross-sectional design was used with a sample of 500 students (264 medical and 236 nursing) at the University of Malaya. A self-administrated questionnaire was used. The responses were analyzed by using descriptive statistics and multiple logistic regression. Of all respondents, 278 (55.6%) were willing to donate organs upon death, while the remaining 222 (44.4%) were unwilling to donate. Only 44 (8.8%) had donor cards. The multiple logistic regression revealed that the minorities ethnic group was more willing to donate organs than Malay respondents (adjusted odds ratio [aOR] = 1.98, P = 0.010). In addition, medical students were more willing to donate than nursing students (aOR = 2.53, P = 0.000). Respondents who have a family member with a donor card were more willing to donate than respondents who do not (aOR = 3.48, P = 0.006). MaNS who believed that their religion permits deceased donation were more willing to donate than their counterparts (aOR = 4.96, P = 0.000). Household income and sex were not significant predictors of MaNS' willingness to donate organs upon death. MaNS have moderate willingness, but low commitment toward deceased organ donation. Strategies for improving MaNS' attitude should better educate them on organ donation, targeting the most the Malay and nursing students, and should consider the influence of family attitude and religious permissibility on MaNS' willingness.

Factors Associated With Medical and Nursing Students’ Willingness to Donate Organs

PubMed Central

Tumin, Makmor; Tafran, Khaled; Tang, Li Yoong; Chong, Mei Chan; Mohd Jaafar, Noor Ismawati; Mohd Satar, NurulHuda; Abdullah, Nurhidayah

2016-01-01

Abstract Malaysia suffers from a chronic shortage of human organs for transplantation. Medical and nursing students (MaNS) are future health professionals and thus their attitude toward organ donation is vital for driving national donation rates. This study investigates MaNS’ willingness to donate organs upon death and the factors influencing their willingness. A cross-sectional design was used with a sample of 500 students (264 medical and 236 nursing) at the University of Malaya. A self-administrated questionnaire was used. The responses were analyzed by using descriptive statistics and multiple logistic regression. Of all respondents, 278 (55.6%) were willing to donate organs upon death, while the remaining 222 (44.4%) were unwilling to donate. Only 44 (8.8%) had donor cards. The multiple logistic regression revealed that the minorities ethnic group was more willing to donate organs than Malay respondents (adjusted odds ratio [aOR] = 1.98, P = 0.010). In addition, medical students were more willing to donate than nursing students (aOR = 2.53, P = 0.000). Respondents who have a family member with a donor card were more willing to donate than respondents who do not (aOR = 3.48, P = 0.006). MaNS who believed that their religion permits deceased donation were more willing to donate than their counterparts (aOR = 4.96, P = 0.000). Household income and sex were not significant predictors of MaNS’ willingness to donate organs upon death. MaNS have moderate willingness, but low commitment toward deceased organ donation. Strategies for improving MaNS’ attitude should better educate them on organ donation, targeting the most the Malay and nursing students, and should consider the influence of family attitude and religious permissibility on MaNS’ willingness. PMID:27015207

Retrospective evaluation of unexpected events during collection of blood donations performed with and without sedation in cats (2010-2013).

PubMed

Doolin, Kerry S; Chan, Daniel L; Adamantos, Sophie; Humm, Karen

2017-09-01

Describe unexpected events (UEs) that occurred during blood donation in cats with and without sedation. Retrospective observational study (2010-2013). University teaching hospital. Client-owned healthy cats enrolled in a blood donation program. None. Blood collection for transfusion was performed 115 times from 32 cats. Seventy donation events were in unsedated cats and 45 in sedated cats. For each collection, the anticipated blood volume to be collected, actual blood volume collected, sedation protocol, and any UE in the peridonation period were recorded. There were 6 categories of UEs: movement during donation, donor anxiety, inadequate collected blood volume, jugular vessel related UEs, additional sedation requirement, and cardiorespiratory distress. Fisher's exact test was used to compare the frequency of UEs between sedated and unsedated cats. UEs were recorded in 54 of 115 collections. In the donor population, movement was reported as an UE in 0 cats that donated under sedation and 24/70 (34.3%) cats that donated without sedation (P < 0.001). Donor anxiety occurred in 2/45 (4.4%) cats that donated under sedation and 14/70 (20.0%) cats that donated unsedated (P = 0.014). Unsedated donation did not increase the likelihood of inadequate donation volume, jugular vessel related UEs, or cardiorespiratory distress. Eight of 45 (17.8%) sedated donations required additional sedation. Movement during donation and signs of donor anxiety were more frequent in unsedated cats. These were considered minor issues, expected in unsedated cats being gently restrained. Blood collection from unsedated feline donors is a viable alternative to sedated donation. © Veterinary Emergency and Critical Care Society 2017.

Donor anxiety, needle pain, and syncopal reactions combine to determine retention: a path analysis of two-year donor return data.

PubMed

France, Christopher R; France, Janis L; Wissel, Mary Ellen; Ditto, Blaine; Dickert, Tara; Himawan, Lina K

2013-09-01

Efforts to expand the donor pool by recruiting younger donors have resulted in higher numbers of initial donations, but retention of young donors continues to be challenging. Path analysis was used to examine the simultaneous relationships among syncopal reactions, donation anxiety, needle pain, donor satisfaction, and donation intention in predicting repeat donation. Participants included 421 first- and second-time donors recruited for a study comparing the effects of predonation water loading with and without the use of applied muscle tension during donation (52% female, 60.8% first-time donor, mean age 20.3 years). For this longitudinal follow-up study, donor database records were accessed 2 years after the index donation to assess repeat donation. Results of a series of path analyses demonstrated the influential role of donor anxiety in shaping donor retention (final model χ(2) = 35.75, root mean square error of approximation 0.03, comparative fit index 0.98, weighted root mean square residual 0.74). First, anxiety exerted a direct negative influence on donation intention, the proximal and sole direct predictor of repeat donation. Second, anxiety increased the likelihood of donor-reported needle pain, adversely affecting donation satisfaction and, subsequently, donation intention. Finally, anxiety was associated with donor ratings of syncopal reactions through its impact on needle pain, which also contributed to decreased donation intention. These results provide novel evidence that donation anxiety plays a central role in shaping future donation behavior. Individual differences in anxiety must be considered when developing and testing strategies to enhance blood donor retention. © 2013 American Association of Blood Banks.

Blood donation practices and willingness to donate among residents of an urban slum in Lagos Nigeria.

PubMed

Sekoni, A O; Balogun, M R; Odukoya, O O; Inem, V; Onigbogi, O O

2014-03-01

This study was carried out to assess the blood donation practices and willingness to donate among residents of an urban slum. Cross sectional descriptive study design with a qualitative and quantitative component. Multistage sampling was used to select 400 respondents for the questionnaire interview while three FGD sessions were conducted guide among three groups of participants namely youths, men and women. The information collected was analyzed manually (FGD) and with Epi info version 3.5.3. Majority of the questionnaire respondents were female, married, traders, had at least secondary school education, with mean age of 37.6 years. Only 12.0% had donated in the past, the main reason given by non donors was that they had never been asked to donate; this was also a key finding in the FGD. Willingness to donate was positively associated with being a male, single and Christian, age was a significant predictor of previous donation while more of the previous donors were still willing to donate, more for family/friends (p=0.036) than voluntarily (p=0.001) this view was supported by the participants at the FGD. Members of this urban slum had poor practice of blood donation,had positive attitude and were willing to donate, there is need to mobilise and organise outreach blood donation programs to convert attitude into actual practice.

Risk Behavior and Reciprocity of Organ Donation Attitudes in Young Men.

PubMed

Vetterli, D C M; Lava, S A G; Essig, S; Milosevic, G; Cajöri, G; Uehlinger, D E; Moor, M B

2015-01-01

Lack of donor organs remains a major obstacle in organ transplantation. Our aim was to evaluate (1) the association between engaging in high-risk recreational activities and attitudes toward organ donation and (2) the degree of reciprocity between organ acceptance and donation willingness in young men. A 17-item, close-ended survey was offered to male conscripts ages 18 to 26 years in all Swiss military conscription centers. Predictors of organ donation attitudes were assessed in bivariate analyses and multiple logistic regression. Reciprocity of the intentions to accept and to donate organs was assessed by means of donor card status. In 1559 responses analyzed, neither motorcycling nor practicing extreme sports reached significant association with donor card holder status. Family communication about organ donation, student, or academic profession and living in a Latin linguistic region were predictors of positive organ donation attitudes, whereas residence in a German-speaking region and practicing any religion predicted reluctance. Significantly more respondents were willing to accept than to donate organs, especially among those without family communication concerning organ donation. For the first time, it was shown that high-risk recreational activities do not influence organ donation attitudes. Second, a considerable discrepancy in organ donation reciprocity was identified. We propose that increasing this reciprocity could eventually increase organ donation rates. Copyright © 2015 Elsevier Inc. All rights reserved.

Vascularized Composite Allograft Donation and Transplantation: A Survey of Public Attitudes in the United States.

PubMed

Rodrigue, J R; Tomich, D; Fleishman, A; Glazier, A K

2017-10-01

Vascularized composite allograft (VCA) transplantation has emerged as a groundbreaking surgical intervention to return identity and function following traumatic injury, congenital deformity, or disfigurement. While public attitudes toward traditional organ/tissue donation are favorable, little is known about attitudes toward VCA donation and transplantation. A survey was conducted of 1485 U.S. residents in August 2016 to assess VCA donation attitudes. Participants also completed the Revised Health Care System Distrust Scale. Most respondents were willing to donate hands/forearms (67.4%) and legs (66.8%), and almost half (48.0%) were willing to donate the face. Three-quarters (74.4%) of women were willing to donate the uterus; 54.4% of men were willing to donate the penis. VCA donation willingness was more likely among whites and Hispanics (p < 0.001), registered organ/tissue donors (p < 0.001), and those with less health care system distrust (p < 0.001) and media exposure to VCA transplantation (p = 0.003). Many who opposed VCA donation expressed concerns about psychological discomfort, mutilation, identity loss, and the reaction of others to seeing familiar body parts on a stranger. Attitudes toward VCA donation are favorable overall, despite limited exposure to VCA messaging and confusion about how VCA donation occurs. These findings may help guide the development and implementation of VCA public education campaigns. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

The infectious disease blood safety risk of Australian hemochromatosis donations.

PubMed

Hoad, Veronica; Bentley, Peter; Bell, Barbara; Pathak, Praveen; Chan, Hiu Tat; Keller, Anthony

2016-12-01

It has been suggested that blood donors with hereditary hemochromatosis may pose an increased infectious disease risk and adversely affect recipient outcomes. This study compares the infectious disease risk of whole blood (WB) donors enrolled as therapeutic (T) donors to voluntary WB donors to evaluate the safety of blood products provided by the T donors. This was a retrospective cohort study of all WB donations at the Australian Red Cross Blood Service who donated between January 1, 2011, and December 31, 2013, comparing a yearly mean of 11,789 T donors with 107,773 total donations and a yearly mean of 468,889 voluntary WB donors with 2,584,705 total donations. We compared postdonation notification of infectious illnesses, bacterial contamination screening results, and positive tests for blood borne viruses in T and WB donors. Rates of transfusion-transmissible infections in donations destined for component manufacture were significantly lower in therapeutic donations compared to voluntary donations (8.4 vs. 21.6 per 100,000 donations). Bacterial contamination (43.0 vs. 45.9 per 100,000 donations) and postdonation illness reporting (136.2 vs. 110.8 per 100,000 donations) were similar in both cohorts. The Australian therapeutic venisection program enables T donors to provide a safe and acceptable source of donated WB that has a low infectious disease risk profile. © 2016 AABB.

Clinical review: Moral assumptions and the process of organ donation in the intensive care unit

PubMed Central

Streat, Stephen

2004-01-01

The objective of the present article is to review moral assumptions underlying organ donation in the intensive care unit. Data sources used include personal experience, and a Medline search and a non-Medline search of relevant English-language literature. The study selection included articles concerning organ donation. All data were extracted and analysed by the author. In terms of data synthesis, a rational, utilitarian moral perspective dominates, and has captured and circumscribed, the language and discourse of organ donation. Examples include "the problem is organ shortage", "moral or social duty or responsibility to donate", "moral responsibility to advocate for donation", "requesting organs" or "asking for organs", "trained requesters", "pro-donation support persons", "persuasion" and defining "maximising donor numbers" as the objective while impugning the moral validity of nonrational family objections to organ donation. Organ donation has recently been described by intensivists in a morally neutral way as an "option" that they should "offer", as "part of good end-of-life care", to families of appropriate patients. In conclusion, the review shows that a rational utilitarian framework does not adequately encompass interpersonal interactions during organ donation. A morally neutral position frees intensivists to ensure that clinical and interpersonal processes in organ donation are performed to exemplary standards, and should more robustly reflect societal acceptability of organ donation (although it may or may not "produce more donors"). PMID:15469581

Interventions for promoting smoke alarm ownership and function.

PubMed

DiGuiseppi, C; Higgins, J P

2001-01-01

Residential fires caused at least 67 deaths and 2,500 non-fatal injuries to children aged 0-16 in the United Kingdom in 1998. Smoke alarm ownership is associated with a reduced risk of residential fire death. We evaluated interventions to promote residential smoke alarms, to assess their effect on smoke alarm ownership, smoke alarm function, fires and burns and other fire-related injuries. We searched the Cochrane Controlled Trials Register, Cochrane Injuries Group database, MEDLINE, EMBASE, PsycLIT, CINAHL, ERIC, Dissertation Abstracts, International Bibliography of Social Sciences, ISTP, FIREDOC and LRC. Conference proceedings, published case studies, and bibliographies were systematically searched, and investigators and relevant organisations were contacted, to identify trials. Randomised, quasi-randomised or nonrandomised controlled trials completed or published after 1969 evaluating an intervention to promote residential smoke alarms. Two reviewers independently extracted data and assessed trial quality. We identified 26 trials, of which 13 were randomised. Overall, counselling and educational interventions had only a modest effect on the likelihood of owning an alarm (OR=1.26; 95% CI: 0.87 to 1.82) or having a functional alarm (OR=1.19; 0.85 to 1.66). Counselling as part of primary care child health surveillance had greater effects on ownership (OR=1.96; 1.03 to 3.72) and function (OR=1.72; 0.78 to 3.80). Results were sensitive to trial quality, however, and effects on fire-related injuries were not reported. In two non randomised trials, direct provision of free alarms significantly increased functioning alarms and reduced fire-related injuries. Media and community education showed little benefit in non randomised trials. Counselling as part of child health surveillance may increase smoke alarm ownership and function, but its effects on injuries are unevaluated. Community smoke alarm give-away programmes apparently reduce fire-related injuries, but these trials were not randomised and results must be interpreted cautiously. Further efforts to promote smoke alarms in primary care or through give-away programmes should be evaluated by adequately designed randomised controlled trials measuring injury outcomes.

Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial.

PubMed

Ridley, Emma J; Davies, Andrew R; Parke, Rachael; Bailey, Michael; McArthur, Colin; Gillanders, Lyn; Cooper, David J; McGuinness, Shay

2015-12-24

Nutrition is one of the fundamentals of care provided to critically ill adults. The volume of enteral nutrition received, however, is often much less than prescribed due to multiple functional and process issues. To deliver the prescribed volume and correct the energy deficit associated with enteral nutrition alone, parenteral nutrition can be used in combination (termed "supplemental parenteral nutrition"), but benefits of this method have not been firmly established. A multi-centre, randomised, clinical trial is currently underway to determine if prescribed energy requirements can be provided to critically ill patients by using a supplemental parenteral nutrition strategy in the critically ill. This prospective, multi-centre, randomised, stratified, parallel-group, controlled, phase II trial aims to determine whether a supplemental parenteral nutrition strategy will reliably and safely increase energy intake when compared to usual care. The study will be conducted for 100 critically ill adults with at least one organ system failure and evidence of insufficient enteral intake from six intensive care units in Australia and New Zealand. Enrolled patients will be allocated to either a supplemental parenteral nutrition strategy for 7 days post randomisation or to usual care with enteral nutrition. The primary outcome will be the average energy amount delivered from nutrition therapy over the first 7 days of the study period. Secondary outcomes include protein delivery for 7 days post randomisation; total energy and protein delivery, antibiotic use and organ failure rates (up to 28 days); duration of ventilation, length of intensive care unit and hospital stay. At both intensive care unit and hospital discharge strength and health-related quality of life assessments will be undertaken. Study participants will be followed up for health-related quality of life, resource utilisation and survival at 90 and 180 days post randomisation (unless death occurs first). This trial aims to determine if provision of a supplemental parenteral nutrition strategy to critically ill adults will increase energy intake compared to usual care in Australia and New Zealand. Trial outcomes will guide development of a subsequent larger randomised controlled trial. NCT01847534 (First registered 5 February 2013, last updated 14 October 2015).

Needle aspiration versus intercostal tube drainage for pneumothorax in the newborn.

PubMed

Bruschettini, Matteo; Romantsik, Olga; Ramenghi, Luca Antonio; Zappettini, Simona; O'Donnell, Colm P F; Calevo, Maria Grazia

2016-01-11

Pneumothorax occurs more frequently in the neonatal period than at any other time of life and is associated with increased mortality and morbidity. It may be treated with either needle aspiration or insertion of a chest tube. The former consists of aspiration of air with a syringe through a needle or an angiocatheter, usually through the second or third intercostal space in the midclavicular line. The chest tube is usually placed in the anterior pleural space passing through the sixth intercostal space into the pleural opening, turned anteriorly and directed to the location of the pneumothorax, and then connected to a Heimlich valve or an underwater seal with continuous suction. To compare the efficacy and safety of needle aspiration and intercostal tube drainage in the management of neonatal pneumothorax. We used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 11), MEDLINE via PubMed (1966 to 30 November 2015), EMBASE (1980 to 30 November 2015), and CINAHL (1982 to 30 November 2015). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. Randomised controlled trials, quasi-randomised controlled trials and cluster trials comparing needle aspiration (either with the needle or angiocatheter left in situ or removed immediately after aspiration) to intercostal tube drainage in newborn infants with pneumothorax. For each of the included trial, two authors independently extracted data (e.g. number of participants, birth weight, gestational age, kind of needle and chest tube, choice of intercostal space, pressure and device for drainage) and assessed the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow-up). The primary outcomes considered in this review are mortality during the neonatal period and during hospitalisation. One randomised controlled trial (72 infants) met the inclusion criteria of this review. We found no differences in the rates of mortality (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.27 to 8.45) or complications related to the procedure. After needle aspiration, the angiocatheter was left in situ (mean 27.1 hours) and not removed immediately after the aspiration. The angiocatheter was in place for a shorter duration than the intercostal tube (mean difference (MD) -11.20 hours, 95% CI -15.51 to -6.89). None of the 36 newborns treated with needle aspiration with the angiocatheter left in situ required the placement of an intercostal tube drainage. Overall, the quality of the evidence supporting this finding is low. At present there is insufficient evidence to determine the efficacy and safety of needle aspiration versus intercostal tube drainage in the management of neonatal pneumothorax. Randomised controlled trials comparing the two techniques are warranted.

41 CFR 109-44.701 - Findings justifying donation to public bodies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... donation to public bodies. 109-44.701 Section 109-44.701 Public Contracts and Property Management Federal... UTILIZATION AND DISPOSAL 44-DONATION OF PERSONAL PROPERTY 44.7-Donations of Property to Public Bodies § 109-44.701 Findings justifying donation to public bodies. The Director, Office of Administrative Services and...

39 CFR 777.51 - Acceptance of donations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 39 Postal Service 1 2010-07-01 2010-07-01 false Acceptance of donations. 777.51 Section 777.51... ACQUISITION POLICIES Donations § 777.51 Acceptance of donations. Nothing in these regulations shall prevent a person from making a gift or donation of real property or any part thereof, or any interest therein, or...

45 CFR 2544.150 - How will accepted donations be recorded and used?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false How will accepted donations be recorded and used... FOR NATIONAL AND COMMUNITY SERVICE SOLICITATION AND ACCEPTANCE OF DONATIONS § 2544.150 How will accepted donations be recorded and used? (a) All accepted donations of money and other property will be...

41 CFR 102-37.580 - Who is responsible for costs associated with the donation?

Code of Federal Regulations, 2010 CFR

2010-07-01

... costs associated with the donation? 102-37.580 Section 102-37.580 Public Contracts and Property... PROPERTY 37-DONATION OF SURPLUS PERSONAL PROPERTY Donations to Public Bodies in Lieu of Abandonment/Destruction § 102-37.580 Who is responsible for costs associated with the donation? The recipient public body...

41 CFR 102-37.110 - What are a holding agency's responsibilities in the donation of surplus property?

Code of Federal Regulations, 2010 CFR

2010-07-01

... agency's responsibilities in the donation of surplus property? 102-37.110 Section 102-37.110 Public... MANAGEMENT REGULATION PERSONAL PROPERTY 37-DONATION OF SURPLUS PERSONAL PROPERTY Holding Agency § 102-37.110 What are a holding agency's responsibilities in the donation of surplus property? Your donation...

Exploring Donation Decisions: Beliefs and Preferences for Organ Donation in Australia

ERIC Educational Resources Information Center

Hyde, Melissa K.; White, Katherine M.

2010-01-01

The authors explored common beliefs and preferences for posthumous and living organ donation in Australia where organ donation rates are low and little research exists. Content analysis of discussions revealed the advantage of prolonging/saving life whereas disadvantages differed according to donation context. A range of people/groups perceived to…

45 CFR 2544.150 - How will accepted donations be recorded and used?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false How will accepted donations be recorded and used... FOR NATIONAL AND COMMUNITY SERVICE SOLICITATION AND ACCEPTANCE OF DONATIONS § 2544.150 How will accepted donations be recorded and used? (a) All accepted donations of money and other property will be...

41 CFR 102-37.580 - Who is responsible for costs associated with the donation?

Code of Federal Regulations, 2011 CFR

2011-01-01

... costs associated with the donation? 102-37.580 Section 102-37.580 Public Contracts and Property... PROPERTY 37-DONATION OF SURPLUS PERSONAL PROPERTY Donations to Public Bodies in Lieu of Abandonment/Destruction § 102-37.580 Who is responsible for costs associated with the donation? The recipient public body...

41 CFR 102-37.110 - What are a holding agency's responsibilities in the donation of surplus property?

Code of Federal Regulations, 2013 CFR

2013-07-01

... agency's responsibilities in the donation of surplus property? 102-37.110 Section 102-37.110 Public... MANAGEMENT REGULATION PERSONAL PROPERTY 37-DONATION OF SURPLUS PERSONAL PROPERTY Holding Agency § 102-37.110 What are a holding agency's responsibilities in the donation of surplus property? Your donation...

41 CFR 102-37.580 - Who is responsible for costs associated with the donation?

Code of Federal Regulations, 2012 CFR

2012-01-01

... costs associated with the donation? 102-37.580 Section 102-37.580 Public Contracts and Property... PROPERTY 37-DONATION OF SURPLUS PERSONAL PROPERTY Donations to Public Bodies in Lieu of Abandonment/Destruction § 102-37.580 Who is responsible for costs associated with the donation? The recipient public body...

45 CFR 2544.150 - How will accepted donations be recorded and used?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false How will accepted donations be recorded and used... FOR NATIONAL AND COMMUNITY SERVICE SOLICITATION AND ACCEPTANCE OF DONATIONS § 2544.150 How will accepted donations be recorded and used? (a) All accepted donations of money and other property will be...

42 CFR 433.67 - Limitations on level of FFP for permissible provider-related donations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... provider-related donations. 433.67 Section 433.67 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... permissible provider-related donations. (a)(1) Limitations on bona fide donations. There are no limitations on the amount of bona fide provider-related donations that a State may receive without a reduction in FFP...

39 CFR 777.51 - Acceptance of donations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 39 Postal Service 1 2013-07-01 2013-07-01 false Acceptance of donations. 777.51 Section 777.51... ACQUISITION POLICIES Donations § 777.51 Acceptance of donations. Nothing in these regulations shall prevent a person from making a gift or donation of real property or any part thereof, or any interest therein, or...

41 CFR 109-44.701 - Findings justifying donation to public bodies.

Code of Federal Regulations, 2014 CFR

2014-01-01

... donation to public bodies. 109-44.701 Section 109-44.701 Public Contracts and Property Management Federal... UTILIZATION AND DISPOSAL 44-DONATION OF PERSONAL PROPERTY 44.7-Donations of Property to Public Bodies § 109-44.701 Findings justifying donation to public bodies. The Director, Office of Administrative Services and...

41 CFR 109-44.701 - Findings justifying donation to public bodies.

Code of Federal Regulations, 2013 CFR

2013-07-01

... donation to public bodies. 109-44.701 Section 109-44.701 Public Contracts and Property Management Federal... UTILIZATION AND DISPOSAL 44-DONATION OF PERSONAL PROPERTY 44.7-Donations of Property to Public Bodies § 109-44.701 Findings justifying donation to public bodies. The Director, Office of Administrative Services and...

41 CFR 109-44.701 - Findings justifying donation to public bodies.

Code of Federal Regulations, 2011 CFR

2011-01-01

... donation to public bodies. 109-44.701 Section 109-44.701 Public Contracts and Property Management Federal... UTILIZATION AND DISPOSAL 44-DONATION OF PERSONAL PROPERTY 44.7-Donations of Property to Public Bodies § 109-44.701 Findings justifying donation to public bodies. The Director, Office of Administrative Services and...

39 CFR 777.51 - Acceptance of donations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 39 Postal Service 1 2012-07-01 2012-07-01 false Acceptance of donations. 777.51 Section 777.51... ACQUISITION POLICIES Donations § 777.51 Acceptance of donations. Nothing in these regulations shall prevent a person from making a gift or donation of real property or any part thereof, or any interest therein, or...

39 CFR 777.51 - Acceptance of donations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 39 Postal Service 1 2014-07-01 2014-07-01 false Acceptance of donations. 777.51 Section 777.51... ACQUISITION POLICIES Donations § 777.51 Acceptance of donations. Nothing in these regulations shall prevent a person from making a gift or donation of real property or any part thereof, or any interest therein, or...

42 CFR 433.67 - Limitations on level of FFP for permissible provider-related donations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... provider-related donations. 433.67 Section 433.67 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... permissible provider-related donations. (a)(1) Limitations on bona fide donations. There are no limitations on the amount of bona fide provider-related donations that a State may receive without a reduction in FFP...

39 CFR 777.51 - Acceptance of donations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 39 Postal Service 1 2011-07-01 2011-07-01 false Acceptance of donations. 777.51 Section 777.51... ACQUISITION POLICIES Donations § 777.51 Acceptance of donations. Nothing in these regulations shall prevent a person from making a gift or donation of real property or any part thereof, or any interest therein, or...

41 CFR 102-37.110 - What are a holding agency's responsibilities in the donation of surplus property?

Code of Federal Regulations, 2011 CFR

2011-01-01

... agency's responsibilities in the donation of surplus property? 102-37.110 Section 102-37.110 Public... MANAGEMENT REGULATION PERSONAL PROPERTY 37-DONATION OF SURPLUS PERSONAL PROPERTY Holding Agency § 102-37.110 What are a holding agency's responsibilities in the donation of surplus property? Your donation...

41 CFR 102-37.110 - What are a holding agency's responsibilities in the donation of surplus property?

Code of Federal Regulations, 2012 CFR

2012-01-01

... agency's responsibilities in the donation of surplus property? 102-37.110 Section 102-37.110 Public... MANAGEMENT REGULATION PERSONAL PROPERTY 37-DONATION OF SURPLUS PERSONAL PROPERTY Holding Agency § 102-37.110 What are a holding agency's responsibilities in the donation of surplus property? Your donation...

41 CFR 102-37.110 - What are a holding agency's responsibilities in the donation of surplus property?

Code of Federal Regulations, 2014 CFR

2014-01-01

... agency's responsibilities in the donation of surplus property? 102-37.110 Section 102-37.110 Public... MANAGEMENT REGULATION PERSONAL PROPERTY 37-DONATION OF SURPLUS PERSONAL PROPERTY Holding Agency § 102-37.110 What are a holding agency's responsibilities in the donation of surplus property? Your donation...

41 CFR 102-37.580 - Who is responsible for costs associated with the donation?

Code of Federal Regulations, 2013 CFR

2013-07-01

... costs associated with the donation? 102-37.580 Section 102-37.580 Public Contracts and Property... PROPERTY 37-DONATION OF SURPLUS PERSONAL PROPERTY Donations to Public Bodies in Lieu of Abandonment/Destruction § 102-37.580 Who is responsible for costs associated with the donation? The recipient public body...

45 CFR 2544.150 - How will accepted donations be recorded and used?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false How will accepted donations be recorded and used... FOR NATIONAL AND COMMUNITY SERVICE SOLICITATION AND ACCEPTANCE OF DONATIONS § 2544.150 How will accepted donations be recorded and used? (a) All accepted donations of money and other property will be...

41 CFR 102-37.580 - Who is responsible for costs associated with the donation?

Code of Federal Regulations, 2014 CFR

2014-01-01

... costs associated with the donation? 102-37.580 Section 102-37.580 Public Contracts and Property... PROPERTY 37-DONATION OF SURPLUS PERSONAL PROPERTY Donations to Public Bodies in Lieu of Abandonment/Destruction § 102-37.580 Who is responsible for costs associated with the donation? The recipient public body...

41 CFR 109-44.701 - Findings justifying donation to public bodies.

Code of Federal Regulations, 2012 CFR

2012-01-01

... donation to public bodies. 109-44.701 Section 109-44.701 Public Contracts and Property Management Federal... UTILIZATION AND DISPOSAL 44-DONATION OF PERSONAL PROPERTY 44.7-Donations of Property to Public Bodies § 109-44.701 Findings justifying donation to public bodies. The Director, Office of Administrative Services and...

45 CFR 2544.150 - How will accepted donations be recorded and used?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false How will accepted donations be recorded and used... FOR NATIONAL AND COMMUNITY SERVICE SOLICITATION AND ACCEPTANCE OF DONATIONS § 2544.150 How will accepted donations be recorded and used? (a) All accepted donations of money and other property will be...

Bereaved donor families' experiences of organ and tissue donation, and perceived influences on their decision making.

PubMed

Sque, Magi; Walker, Wendy; Long-Sutehall, Tracy; Morgan, Myfanwy; Randhawa, Gurch; Rodney, Amanda

2018-06-01

To elicit bereaved families' experiences of organ and tissue donation. A specific objective was to determine families' perceptions of how their experiences influenced donation decision-making. Retrospective, qualitative interviews were undertaken with 43 participants of 31 donor families to generate rich, informative data. Participant recruitment was via 10 National Health Service Trusts, representative of five regional organ donation services in the UK. Twelve families agreed to DBD, 18 agreed to DCD, 1 unknown. Participants' responses were contextualised using a temporal framework of 'The Past', which represented families' prior knowledge, experience, attitudes, beliefs, and intentions toward organ donation; 'The Present', which incorporated the moment in time when families experienced the potential for donation; and 'The Future', which corresponded to expectations and outcomes arising from the donation decision. Temporally interwoven experiences appeared to influence families' decisions to donate the organs of their deceased relative for transplantation. The influence of temporality on donation-decision making is worthy of consideration in the planning of future education, policy, practice, and research for improved rates of family consent to donation. Copyright © 2018 Elsevier Inc. All rights reserved.

HIV, HCV, HBV and syphilis rate of positive donations among blood donations in Mali: lower rates among volunteer blood donors.

PubMed

Diarra, A; Kouriba, B; Baby, M; Murphy, E; Lefrere, J-J

2009-01-01

Good data on background seroprevalence of major transfusion transmitted infections is lacking in Mali. We gathered data on the rate of positive donations of human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) and syphilis among blood donations in Mali for calendar year 2007. Donations with repeatedly reactive results on screening enzyme immunoassay (EIA) were considered to be seropositive. Rate of positive donations per blood unit collected was 2.6% for HIV, 3.3% for HCV, 13.9% for hepatitis B surface antigen (HBsAg) and 0.3% for syphilis. For HIV, HBsAg and syphilis, rate of positive donations was significantly (p<0.001) higher among donations from replacement donors than those from volunteer donors, while HCV rate of positive donations was similar in the two groups. Rate of positive donations was also significantly (p<0.0001) lower in blood units from regular than from first-time donors. These data reinforce WHO recommendations for increasing the number of regular, volunteer blood donors in Africa.

Evaluating the effectiveness of a smartphone app to reduce excessive alcohol consumption: protocol for a factorial randomised control trial.

PubMed

Garnett, Claire; Crane, David; Michie, Susan; West, Robert; Brown, Jamie

2016-07-08

Excessive alcohol consumption is a leading cause of death and morbidity worldwide and interventions to help people reduce their consumption are needed. Interventions delivered by smartphone apps have the potential to help harmful and hazardous drinkers reduce their consumption of alcohol. However, there has been little evaluation of the effectiveness of existing smartphone interventions. A systematic review, amongst other methodologies, identified promising modular content that could be delivered by an app: self-monitoring and feedback; action planning; normative feedback; cognitive bias re-training; and identity change. This protocol reports a factorial randomised controlled trial to assess the comparative potential of these five intervention modules to reduce excessive alcohol consumption. A between-subject factorial randomised controlled trial. Hazardous and harmful drinkers aged 18 or over who are making a serious attempt to reduce their drinking will be randomised to one of 32 (2(5)) experimental conditions after downloading the 'Drink Less' app. Participants complete baseline measures on downloading the app and are contacted after 1-month with a follow-up questionnaire. The primary outcome measure is change in past week consumption of alcohol. Secondary outcome measures are change in AUDIT score, app usage data and usability ratings for the app. A factorial between-subjects ANOVA will be conducted to assess main and interactive effects of the five intervention modules for the primary and secondary outcome measures. This study will establish the extent to which the five intervention modules offered in this app can help reduce hazardous and harmful drinking. This is the first step in optimising and understanding what component parts of an app could help to reduce excessive alcohol consumption. The findings from this study will be used to inform the content of a future integrated treatment app and evaluated against a minimal control in a definitive randomised control trial with long-term outcomes. ISRCTN40104069 Date of registration: 10/2/2016.

Electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomised controlled trial.

PubMed

Hwang, Man-Suk; Heo, Kwang-Ho; Cho, Hyun-Woo; Shin, Byung-Cheul; Lee, Hyeon-Yeop; Heo, In; Kim, Nam-Kwen; Choi, Byung-Kwan; Son, Dong-Wuk; Hwang, Eui-Hyoung

2015-02-04

Recurrent or persistent low back pain is common after back surgery but is typically not well controlled. Previous randomised controlled trials on non-acute pain after back surgery were flawed. In this article, the design and protocol of a randomised controlled trial to treat pain and improve function after back surgery are described. This study is a pilot randomised, active-controlled, assessor-blinded trial. Patients with recurring or persistent low back pain after back surgery, defined as a visual analogue scale value of ≥50 mm, with or without leg pain, will be randomly assigned to an electroacupuncture-plus-usual-care group or to a usual-care-only group. Patients assigned to both groups will have usual care management, including physical therapy and patient education, twice a week during a 4-week treatment period that would begin at randomisation. Patients assigned to the electroacupuncture-plus-usual-care group will also have electroacupuncture twice a week during the 4-week treatment period. The primary outcome will be measured with the 100 mm pain visual analogue scale of low back pain by a blinded evaluator. Secondary outcomes will be measured with the EuroQol 5-Dimension and the Oswestry Disability Index. The primary and secondary outcomes will be measured at 4 and 8 weeks after treatment. Written informed consent will be obtained from all participants. This study was approved by the Institutional Review Board (IRB) of Pusan National University Korean Hospital in September 2013 (IRB approval number 2013012). The study findings will be published in peer-reviewed journals and presented at national and international conferences. This trial was registered with the US National Institutes of Health Clinical Trials Registry: NCT01966250. 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.

An educational intervention to reduce pain and improve pain management for Malawian people living with HIV/AIDS and their family carers: study protocol for a randomised controlled trial.

PubMed

Nkhoma, Kennedy; Seymour, Jane; Arthur, Antony

2013-07-13

Many HIV/AIDS patients experience pain often due to advanced HIV/AIDS infection and side effects of treatment. In sub-Saharan Africa, pain management for people with HIV/AIDS is suboptimal. With survival extended as a direct consequence of improved access to antiretroviral therapy, the prevalence of HIV/AIDS related pain is increasing. As most care is provided at home, the management of pain requires patient and family involvement. Pain education is an important aspect in the management of pain in HIV/AIDS patients. Studies of the effectiveness of pain education interventions for people with HIV/AIDS have been conducted almost exclusively in western countries. A randomised controlled trial is being conducted at the HIV and palliative care clinics of two public hospitals in Malawi. To be eligible, patient participants must have a diagnosis of HIV/AIDS (stage III or IV). Carer participants must be the individual most involved in the patient's unpaid care. Eligible participants are randomised to either: (1) a 30-minute face-to-face educational intervention covering pain assessment and management, augmented by a leaflet and follow-up telephone call at two weeks; or (2) usual care. Those allocated to the usual care group receive the educational intervention after follow-up assessments have been conducted (wait-list control group). The primary outcome is pain severity measured by the Brief Pain Inventory. Secondary outcomes are pain interference, patient knowledge of pain management, patient quality of life, carer knowledge of pain management, caregiver motivation and carer quality of life. Follow-up assessments are conducted eight weeks after randomisation by palliative care nurses blind to allocation. This randomised controlled trial conducted in sub-Saharan Africa among people living with HIV/AIDS and their carers will assess whether a pain education intervention is effective in reducing pain and improving pain management, quality of life and carer motivation. Current Controlled Trials ISRCTN72861423.

The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

PubMed Central

2013-01-01

Background Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder. PMID:23289935

Effects of treatment in women with gestational diabetes mellitus: systematic review and meta-analysis.

PubMed

Horvath, Karl; Koch, Klaus; Jeitler, Klaus; Matyas, Eva; Bender, Ralf; Bastian, Hilda; Lange, Stefan; Siebenhofer, Andrea

2010-04-01

To summarise the benefits and harms of treatments for women with gestational diabetes mellitus. Systematic review and meta-analysis of randomised controlled trials. Embase, Medline, AMED, BIOSIS, CCMed, CDMS, CDSR, CENTRAL, CINAHL, DARE, HTA, NHS EED, Heclinet, SciSearch, several publishers' databases, and reference lists of relevant secondary literature up to October 2009. Review methods Included studies were randomised controlled trials of specific treatment for gestational diabetes compared with usual care or "intensified" compared with "less intensified" specific treatment. Five randomised controlled trials matched the inclusion criteria for specific versus usual treatment. All studies used a two step approach with a 50 g glucose challenge test or screening for risk factors, or both, and a subsequent 75 g or 100 g oral glucose tolerance test. Meta-analyses did not show significant differences for most single end points judged to be of direct clinical importance. In women specifically treated for gestational diabetes, shoulder dystocia was significantly less common (odds ratio 0.40, 95% confidence interval 0.21 to 0.75), and one randomised controlled trial reported a significant reduction of pre-eclampsia (2.5 v 5.5%, P=0.02). For the surrogate end point of large for gestational age infants, the odds ratio was 0.48 (0.38 to 0.62). In the 13 randomised controlled trials of different intensities of specific treatments, meta-analysis showed a significant reduction of shoulder dystocia in women with more intensive treatment (0.31, 0.14 to 0.70). Treatment for gestational diabetes, consisting of treatment to lower blood glucose concentration alone or with special obstetric care, seems to lower the risk for some perinatal complications. Decisions regarding treatment should take into account that the evidence of benefit is derived from trials for which women were selected with a two step strategy (glucose challenge test/screening for risk factors and oral glucose tolerance test).

A Scoping Review of Economic Evaluations Alongside Randomised Controlled Trials of Home Monitoring in Chronic Disease Management.

PubMed

Kidholm, Kristian; Kristensen, Mie Borch Dahl

2018-04-01

Many countries have considered telemedicine and home monitoring of patients as a solution to the demographic challenges that health-care systems face. However, reviews of economic evaluations of telemedicine have identified methodological problems in many studies as they do not comply with guidelines. The aim of this study was to examine economic evaluations alongside randomised controlled trials of home monitoring in chronic disease management and hereby to explore the resources included in the programme costs, the types of health-care utilisation that change as a result of home monitoring and discuss the value of economic evaluation alongside randomised controlled trials of home monitoring on the basis of the studies identified. A scoping review of economic evaluations of home monitoring of patients with chronic disease based on randomised controlled trials and including information on the programme costs and the costs of equipment was carried out based on a Medline (PubMed) search. Nine studies met the inclusion criteria. All studies include both costs of equipment and use of staff, but there is large variation in the types of equipment and types of tasks for the staff included in the costs. Equipment costs constituted 16-73% of the total programme costs. In six of the nine studies, home monitoring resulted in a reduction in primary care or emergency contacts. However, in total, home monitoring resulted in increased average costs per patient in six studies and reduced costs in three of the nine studies. The review is limited by the small number of studies found and the restriction to randomised controlled trials, which can be problematic in this area due to lack of blinding of patients and healthcare professionals and the difficulty of implementing organisational changes in hospital departments for the limited period of a trial. Furthermore, our results may be based on assessments of older telemedicine interventions.

Desmopressin acetate (DDAVP) for preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders.

PubMed

Karanth, Laxminarayan; Barua, Ankur; Kanagasabai, Sachchithanantham; Nair, Sreekumar

2015-09-09

Congenital bleeding disorders can cause obstetric haemorrhage during pregnancy, labour and following delivery. Desmopressin acetate is found to be an effective drug which can reduce the risk of haemorrhage and can also stop bleeding in certain congenital bleeding disorders. Its use in pregnancy has been controversial. Hence beneficial and adverse effects of desmopressin acetate in these groups of pregnant women should be evaluated.This is an update of a Cochrane review first published in 2013. To determine the efficacy of desmopressin acetate in preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coaguopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant and abstract books of conferences proceedings. We also searched for any randomised controlled trials in a registry of ongoing trials and the reference lists of relevant articles and reviews.Date of most recent search: 18 June 2015. Randomised and quasi-randomised controlled trials investigating the efficacy of desmopressin acetate versus tranexamic acid or factor VIII or rFactor VII or fresh frozen plasma in preventing and treating congenital bleeding disorders during pregnancy were eligible. No trials matching the selection criteria were eligible for inclusion. No trials matching the selection criteria were eligible for inclusion. The review did not identify any randomised controlled trials investigating the relative effectiveness of desmopressin acetate for bleeding during pregnancy in women with congenital bleeding disorders. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials) to decide whether or not to treat women with congenital bleeding disorders with desmopressin acetate.Given the ethical considerations, future randomised controlled trials are unlikely. However, other high quality controlled studies (such as risk allocation designs, sequential design, parallel cohort design) to investigate the risks and benefits of using desmopressin acetate in this population are needed.

Desmopressin acetate (DDAVP) for preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders.

PubMed

Karanth, Laxminarayan; Barua, Ankur; Kanagasabai, Sachchithanantham; Nair, N S

2013-04-30

Congenital bleeding disorders can cause obstetric haemorrhage during pregnancy, labour and following delivery. Desmopressin acetate is found to be an effective drug which can reduce the risk of haemorrhage and can also stop bleeding in certain congenital bleeding disorders. Its use in pregnancy has been controversial. Hence beneficial and adverse effects of desmopressin acetate in these groups of pregnant women should be evaluated. To determine the efficacy of desmopressin acetate in preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coaguopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant and abstract books of conferences proceedings. We also searched for any randomised controlled trials in a registry of ongoing trials and the reference lists of relevant articles and reviews.Date of most recent search: 28 February 2013. Randomised and quasi-randomised controlled trials investigating the efficacy of desmopressin acetate versus tranexamic acid or factor VIII or rFactor VII or fresh frozen plasma in preventing and treating congenital bleeding disorders during pregnancy were eligible. No trials matching the selection criteria were eligible for inclusion. No trials matching the selection criteria were eligible for inclusion. The review did not identify any randomised controlled trials investigating the relative effectiveness of desmopressin acetate for bleeding during pregnancy in women with congenital bleeding disorders. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials) to decide whether or not to treat women with congenital bleeding disorders with desmopressin acetate.Given the ethical considerations, future randomised controlled trials are unlikely. However, other high quality controlled studies (such as risk allocation designs, sequential design, parallel cohort design) to investigate the risks and benefits of using desmopressin acetate in this population are needed.

5 CFR 2601.301 - Accounting of gifts.

Code of Federal Regulations, 2010 CFR

2010-01-01

... accounted for by following appropriate internal controls and accounting procedures. (b) The Administration Division shall maintain an inventory of donated personal property valued at over $500. The inventory shall...

Platelet Donation

MedlinePlus

... How to Donate Find a Blood Drive Eligibility Requirements Types of Blood Donations How Blood Donations Help ... 24 times a year. Read more about eligibility requirements including travel and medication restrictions. Who is eligible ...

Risk factors for complications in donors at first and repeat whole blood donation: a cohort study with assessment of the impact on donor return

PubMed Central

Wiersum-Osselton, Johanna C.; Marijt-van derKreek, Tanneke; Brand, Anneke; Veldhuizen, Ingrid; van der Bom, Johanna G.; de Kort, Wim

2014-01-01

Background First-time donation is among recognised risk factors for vasovagal reactions to blood donation and reactions are known to reduce donor return. We assessed associations between potential risk factors and vasovagal reactions and needle-related complications in first-time whole blood donation in comparison to repeat donation and analysed the impact of complications on donor return. Materials and methods We performed a cohort study on whole blood donations in The Netherlands from 1/1/2010 to 31/12/2010 using data extracted from the blood service information system. Donation data up to 31/12/2011 were used to ascertain donor return. Results In 2010 28,786 donors made first whole blood donations and there were 522,958 repeat donations. Vasovagal reactions occurred in 3.9% of first donations by males and 3.5% of first donations by females compared to in 0.2% and 0.6%, respectively, of repeat donations. Associations of vasovagal reactions with other factors including age, body weight, systolic and diastolic blood pressure were similar in first-time and repeat donors. Needle-related complications occurred in 0.2% of male and 0.5% of female first-time donations and in 0.1% and 0.3%, respectively, of repeat donations. Among first-time donors, the return rate within 1 year was 82% following an uncomplicated first donation, but 55% and 61% following vasovagal reactions and needle-related complications, respectively; the corresponding percentages among repeat donors were 86%, 58% and 82%. Discussion Among first-time donors, females suffered less than males from vasovagal reactions. Other risk factors had similar associations among first-time and repeat donors. Vasovagal reactions and needle-related complications in both first-time and repeat donors are followed by reduced donor return. PMID:23867173

Attitudes of Swiss mothers toward unrelated umbilical cord blood banking 6 months after donation.

PubMed

Danzer, Enrico; Holzgreve, Wolfgang; Troeger, Carolyn; Kostka, Ulrike; Steimann, Sabine; Bitzer, Johanes; Gratwohl, Alois; Tichelli, André; Seelmann, Kurt; Surbek, Daniel V

2003-05-01

During the past decade, the use of umbilical cord blood (CB) as a source of transplantable hematopoietic stem cells has been increasing. Little is known about the psychosocial consequences that later affect parents after unrelated CB donation. The objective of this study was to evaluate the attitudes of mothers toward unrelated donation of umbilical CB for transplantation 6 months after giving birth. A prospective study was performed with a standardized, anonymous questionnaire distributed to 131 women 6 months after CB donation. The questionnaire included topics concerning views about the ethical accuracy of having donated CB, emotional responses after donation, concerns about genetic testing and research with CB samples, attitude toward anonymity between her child and possible unrelated CB recipient, and willingness to repeatedly donate umbilical CB in a next pregnancy. The vast majority (96.1%) stated that they would donate umbilical CB again, and all respondents were certain that their decision to have donated umbilical CB was ethical. With regard to the potential risks of genetic testing and "experimentation" of umbilical CB, a significant correlation (p = 0.01) was found between negative attitudes and the decision not to donate umbilical CB again. Additionally, it was observed that women who had a negative experience concerning the donation of CB would not donate again (p = 0.004). This study shows a high degree of satisfaction of unrelated umbilical CB donation for banking in women 6 months after delivery. Despite a well-performed and detailed informed consent procedure, one of the ongoing issues for the donators in CB banking involves the concern regarding of improper use of the cells, such as genetic testing or experimentation. Accurate and detailed counseling of pregnant women and their partners therefore maximizes the likelihood that they will donate CB for unrelated banking. These data provide a basis for the improvement of donor selection procedures and public education regarding the use of CB for banking and transplantation.

A comparison of human immunodeficiency virus, hepatitis C virus, hepatitis B virus, and human T-lymphotropic virus marker rates for directed versus volunteer blood donations to the American Red Cross during 2005 to 2010.

PubMed

Dorsey, Kerri A; Moritz, Erin D; Steele, Whitney R; Eder, Anne F; Stramer, Susan L

2013-06-01

At most US blood centers, patients may still opt to choose specific donors to give blood for their anticipated transfusion needs. However, there is little evidence of improved safety with directed donation when compared to volunteer donation. The percentage of directed donations made to the American Red Cross (ARC) from 1995 to 2010 was determined. Infectious disease marker rates for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), and human T-lymphotropic virus (HTLV) were calculated for volunteer and directed donations made from 2005 to 2010. Odds ratios (ORs) were calculated to compare marker-positive rates of directed donations to volunteer donations. The percentage of donations from directed donors declined from 1.6% in 1995 to 0.12% in 2010. From 2005 to 2010, the ARC collected 38,894,782 volunteer and 69,869 directed donations. Rates of HIV, HCV, HBV, and HTLV for volunteer donations were 2.9, 32.2, 12.4, and 2.5 per 100,000 donations, respectively; for directed, the rates were 7.2, 93.0, 40.1, and 18.6 per 100,000. After demographics and first-time or repeat status were adjusted for, corresponding ORs of viral marker positivity in directed versus volunteer donations were not significant for HIV, HBV, or HTLV and significant for HCV (OR, 0.7; 95% confidence interval, 0.50-0.90). Directed donations have declined by 92% at the ARC since 1995, but have higher viral marker rates than volunteer donations. The difference can be explained in part by the effects of first-time or repeat status of the donors. Patients considering directed donation should be appropriately counseled about the potential risks. © 2012 American Association of Blood Banks.