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Sample records for repeated trials participants

  1. Acceptability and feasibility of repeated mucosal specimen collection in clinical trial participants in Kenya.

    Directory of Open Access Journals (Sweden)

    Gloria Omosa-Manyonyi

    Full Text Available Mucosal specimens are essential to evaluate compartmentalized immune responses to HIV vaccine candidates and other mucosally targeted investigational products. We studied the acceptability and feasibility of repeated mucosal sampling in East African clinical trial participants at low risk of HIV and other sexually transmitted infections.The Kenya AIDS Vaccine Initiative (KAVI enrolled participants into three Phase 1 trials of preventive HIV candidate vaccines in 2011-2012 at two clinical research centers in Nairobi. After informed consent to a mucosal sub-study, participants were asked to undergo collection of mucosal secretions (saliva, oral fluids, semen, cervico-vaginal and rectal, but could opt out of any collection at any visit. Specimens were collected at baseline and two additional time points. A tolerability questionnaire was administered at the final sub-study visit. Of 105 trial participants, 27 of 34 women (79% and 62 of 71 men (87% enrolled in the mucosal sub-study. Nearly all sub-study participants gave saliva and oral fluids at all visits. Semen was collected from about half the participating men (47-48% at all visits. Cervico-vaginal secretions were collected by Softcup from about two thirds of women (63% at baseline, increasing to 78% at the following visits, with similar numbers for cervical secretion collection by Merocel sponge; about half of women (52% gave cervico-vaginal samples at all visits. Rectal secretions were collected with Merocel sponge from about a quarter of both men and women (24% at all 3 visits, with 16% of men and 19% of women giving rectal samples at all visits.Repeated mucosal sampling in clinical trial participants in Kenya is feasible, with a good proportion of participants consenting to most sampling methods with the exception of rectal samples. Experienced staff members of both sexes and trained counselors with standardized messaging may improve acceptance of rectal sampling.

  2. Comparison of trial participants and open access users of a web-based physical activity intervention regarding adherence, attrition, and repeated participation.

    Science.gov (United States)

    Wanner, Miriam; Martin-Diener, Eva; Bauer, Georg; Braun-Fahrländer, Charlotte; Martin, Brian W

    2010-02-10

    Web-based interventions are popular for promoting healthy lifestyles such as physical activity. However, little is known about user characteristics, adherence, attrition, and predictors of repeated participation on open access physical activity websites. The focus of this study was Active-online, a Web-based individually tailored physical activity intervention. The aims were (1) to assess and compare user characteristics and adherence to the website (a) in the open access context over time from 2003 to 2009, and (b) between trial participants and open access users; and (2) to analyze attrition and predictors of repeated use among participants in a randomized controlled trial compared with registered open access users. Data routinely recorded in the Active-online user database were used. Adherence was defined as: the number of pages viewed, the proportion of visits during which a tailored module was begun, the proportion of visits during which tailored feedback was received, and the time spent in the tailored modules. Adherence was analyzed according to six one-year periods (2003-2009) and according to the context (trial or open access) based on first visits and longest visits. Attrition and predictors of repeated participation were compared between trial participants and open access users. The number of recorded visits per year on Active-online decreased from 42,626 in 2003-2004 to 8343 in 2008-2009 (each of six one-year time periods ran from April 23 to April 22 of the following year). The mean age of users was between 38.4 and 43.1 years in all time periods and both contexts. The proportion of women increased from 49.5% in 2003-2004 to 61.3% in 2008-2009 (Popen access users. For open access users, adherence was similar during the first and the longest visits; for trial participants, adherence was lower during the first visits and higher during the longest visits. Of registered open access users and trial participants, 25.8% and 67.3% respectively visited Active

  3. Trial of Repeated Analgesia with Kangaroo Mother Care (TRAKC Trial)

    Science.gov (United States)

    2013-01-01

    Background Skin-to-skin contact (SSC) between mother and infant, commonly referred to as Kangaroo Mother Care (KMC), is recommended as an intervention for procedural pain. Evidence demonstrates its consistent efficacy in reducing pain for a single painful procedure. The purpose of this study is to examine the sustained efficacy of KMC, provided during all routine painful procedures for the duration of Neonatal Intensive Care Unit (NICU) hospitalization, in diminishing behavioral pain response in preterm neonates. The efficacy of KMC alone will be compared to standard care of 24% oral sucrose, as well as the combination of KMC and 24% oral sucrose. Methods/design Infants admitted to the NICU who are less than 36 6/7 weeks gestational age (according to early ultrasound), that are stable enough to be held in KMC, will be considered eligible (N = 258). Using a single-blinded randomized parallel group design, participants will be assigned to one of three possible interventions: 1) KMC, 2) combined KMC and sucrose, and 3) sucrose alone, when they undergo any routine painful procedure (heel lance, venipuncture, intravenous, oro/nasogastric insertion). The primary outcome is infant’s pain intensity, which will be assessed using the Premature Infant Pain Profile (PIPP). The secondary outcome will be maturity of neurobehavioral functioning, as measured by the Neurobehavioral Assessment of the Preterm Infant (NAPI). Gestational age, cumulative exposure to KMC provided during non-pain contexts, and maternal cortisol levels will be considered in the analysis. Clinical feasibility will be accounted for from nurse and maternal questionnaires. Discussion This will be the first study to examine the repeated use of KMC for managing procedural pain in preterm neonates. It is also the first to compare KMC to sucrose, or the interventions in combination, across time. Based on the theoretical framework of the brain opioid theory of attachment, it is expected that KMC will be a

  4. Participation behavior and social welfare in repeated task allocations

    NARCIS (Netherlands)

    Ye, Q.C.; Zhang, Y.

    2016-01-01

    Task allocation problems have focused on achieving one-shot optimality. In practice, many task allocation problems are of repeated nature, where the allocation outcome of previous rounds may influence the participation of agents in subsequent rounds, and consequently, the quality of the allocations

  5. Internet trials: participant experiences and perspectives.

    Science.gov (United States)

    Mathieu, Erin; Barratt, Alexandra; Carter, Stacy M; Jamtvedt, Gro

    2012-10-23

    Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants' attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate). Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants' comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience - a perceived benefit - and a lack connectedness and understanding - a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and confidentiality issues; perceived benefits and

  6. Internet trials: participant experiences and perspectives

    Science.gov (United States)

    2012-01-01

    Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. Objective To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. Methods All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate). Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants’ comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience – a perceived benefit – and a lack connectedness and understanding – a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and

  7. Internet trials: participant experiences and perspectives

    Directory of Open Access Journals (Sweden)

    Mathieu Erin

    2012-10-01

    Full Text Available Abstract Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. Objective To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. Methods All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate. Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants’ comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience – a perceived benefit – and a lack connectedness and understanding – a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet

  8. Credentialing for participation in clinical trials

    International Nuclear Information System (INIS)

    Followill, David S.; Urie, Marcia; Galvin, James M.; Ulin, Kenneth; Xiao, Ying; FitzGerald, Thomas J.

    2012-01-01

    The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

  9. Credentialing for participation in clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Followill, David S. [Radiological Physics Center, Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Urie, Marcia [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); Ulin, Kenneth [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States); Xiao, Ying [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); FitzGerald, Thomas J., E-mail: dfollowi@mdanderson.org [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States)

    2012-12-26

    The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

  10. Analysis of repeated measurement data in the clinical trials

    Science.gov (United States)

    Singh, Vineeta; Rana, Rakesh Kumar; Singhal, Richa

    2013-01-01

    Statistics is an integral part of Clinical Trials. Elements of statistics span Clinical Trial design, data monitoring, analyses and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of Clinical Trials. In biomedical research it has been seen that researcher frequently use t-test and ANOVA to compare means between the groups of interest irrespective of the nature of the data. In Clinical Trials we record the data on the patients more than two times. In such a situation using the standard ANOVA procedures is not appropriate as it does not consider dependencies between observations within subjects in the analysis. To deal with such types of study data Repeated Measure ANOVA should be used. In this article the application of One-way Repeated Measure ANOVA has been demonstrated by using the software SPSS (Statistical Package for Social Sciences) Version 15.0 on the data collected at four time points 0 day, 15th day, 30th day, and 45th day of multicentre clinical trial conducted on Pandu Roga (~Iron Deficiency Anemia) with an Ayurvedic formulation Dhatrilauha. PMID:23930038

  11. Motivators for Alzheimer's disease clinical trial participation.

    Science.gov (United States)

    Bardach, Shoshana H; Holmes, Sarah D; Jicha, Gregory A

    2018-02-01

    Alzheimer's disease (AD) research progress is impeded due to participant recruitment challenges. This study seeks to better understand, from the perspective of individuals engaged in clinical trials (CTs), research motivations. Participants, or their caregivers, from AD treatment and prevention CTs were surveyed about research motivators. The 87 respondents had a mean age of 72.2, were predominantly Caucasian, 55.2% were male, and 56.3% had cognitive impairment. An overwhelming majority rated the potential to help themselves or a loved one and the potential to help others in the future as important motivators. Relatively few respondents were motivated by free healthcare, monetary rewards, or to make others happy. Recruitment efforts should focus on the potential benefit for the individual, their loved ones, and others in the future rather than free healthcare or monetary rewards.

  12. Repeat testing of low-level HIV-1 RNA: assay performance and implementation in clinical trials.

    Science.gov (United States)

    White, Kirsten; Garner, Will; Wei, Lilian; Eron, Joseph J; Zhong, Lijie; Miller, Michael D; Martin, Hal; Plummer, Andrew; Tran-Muchowski, Cecilia; Lindstrom, Kim; Porter, James; Piontkowsky, David; Light, Angela; Reiske, Heinz; Quirk, Erin

    2018-05-15

    Assess the performance of HIV-1 RNA repeat testing of stored samples in cases of low-level viremia during clinical trials. Prospective and retrospective analysis of randomized clinical trial samples and reference standards. To evaluate assay variability of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, v2.0, three separate sources of samples were utilized: the World Health Organization (WHO) HIV reference standard (assayed using 50 independent measurements at six viral loads <200 copies/ml), retrospective analysis of four to six aliquots of plasma samples from four clinical trial participants, and prospective repeat testing of 120 samples from participants in randomized trials with low-level viremia. The TaqMan assay on the WHO HIV-1 RNA standards at viral loads <200 copies/ml performed within the expected variability according to assay specifications. However, standards with low viral loads of 36 and 18 copies/ml reported values of ≥ 50 copies/ml in 66 and 18% of tests, respectively. In participants treated with antiretrovirals who had unexpected viremia of 50-200 copies/ml after achieving <50 copies/ml, retesting of multiple aliquots of stored plasma found <50 copies/ml in nearly all cases upon retesting (14/15; 93%). Repeat testing was prospectively implemented in four clinical trials for all samples with virologic rebound of 50-200 copies/ml (n = 120 samples from 92 participants) from which 42% (50/120) had a retest result of less than 50 copies/ml and 58% (70/120) retested ≥ 50 copies/ml. The TaqMan HIV-1 RNA assay shows variability around 50 copies/ml that affects clinical trial results and may impact clinical practice. In participants with a history of viral load suppression, unexpected low-level viremia may be because of assay variability rather than low drug adherence or true virologic failure. Retesting a stored aliquot of the same sample may differentiate between assay variability and virologic failure as the source of viremia

  13. Minocycline Prevents Muscular Pain Hypersensitivity and Cutaneous Allodynia Produced by Repeated Intramuscular Injections of Hypertonic Saline in Healthy Human Participants.

    Science.gov (United States)

    Samour, Mohamad Samir; Nagi, Saad Saulat; Shortland, Peter John; Mahns, David Anthony

    2017-08-01

    Minocycline, a glial suppressor, prevents behavioral hypersensitivities in animal models of peripheral nerve injury. However, clinical trials of minocycline in human studies have produced mixed results. This study addressed 2 questions: can repeated injections of hypertonic saline (HS) in humans induce persistent hypersensitivity? Can pretreatment with minocycline, a tetracycline antibiotic with microglial inhibitory effects, prevent the onset of hypersensitivity? Twenty-seven healthy participants took part in this double-blind, placebo-controlled study, consisting of 6 test sessions across 2 weeks. At the beginning of every session, pressure-pain thresholds of the anterior muscle compartment of both legs were measured to determine the region distribution and intensity of muscle soreness. To measure changes in thermal sensitivity in the skin overlying the anterior muscle compartment of both legs, quantitative sensory testing was used to measure the cutaneous thermal thresholds (cold sensation, cold pain, warm sensation, and heat pain) and a mild cooling stimulus was applied to assess the presence of cold allodynia. To induce ongoing hypersensitivity, repeated injections of HS were administered into the right tibialis anterior muscle at 48-hour intervals. In the final 2 sessions (days 9 and 14), only sensory assessments were done to plot the recovery after cessation of HS administrations and drug washout. By day 9, nontreated participants experienced a significant bilateral increase in muscle soreness (P minocycline-treated participants experienced a bilateral 70% alleviation in muscle soreness (P minocycline-treated participants showed cold allodynia. This study showed that repeated injections of HS can induce a hypersensitivity that outlasts the acute response, and the development of this hypersensitivity can be reliably attenuated with minocycline pretreatment. Four repeated injections of HS at 48-hour intervals induce a state of persistent hypersensitivity in

  14. Repeat participation in annual cross-sectional surveys of drug users and its implications for analysis.

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    Agius, P A; Aitken, C K; Breen, C; Dietze, P M

    2018-06-04

    We sought to establish the extent of repeat participation in a large annual cross-sectional survey of people who inject drugs and assess its implications for analysis. We used "porn star names" (the name of each participant's first pet followed by the name of the first street in which they lived) to identify repeat participation in three Australian Illicit Drug Reporting System surveys. Over 2013-2015, 2468 porn star names (96.2%) appeared only once, 88 (3.4%) twice, and nine (0.4%) in all 3 years. We measured design effects, based on the between-cluster variability for selected estimates, of 1.01-1.07 for seven key variables. These values indicate that the complex sample is (e.g.) 7% less efficient in estimating prevalence of heroin use (ever) than a simple random sample, and 1% less efficient in estimating number of heroin overdoses (ever). Porn star names are a useful means of tracking research participants longitudinally while maintaining their anonymity. Repeat participation in the Australian Illicit Drug Reporting System is low (less than 5% per annum), meaning point-prevalence and effect estimation without correction for the lack of independence in observations is unlikely to seriously affect population inference.

  15. Motives for (not) participating in a lifestyle intervention trial

    DEFF Research Database (Denmark)

    Lakerveld, J.; IJzelenberg, W.; van Tulder, M.

    2008-01-01

    : the perception of being unhealthy and willingness to change their lifestyle. The main barriers reported by non-participants were financial arguments and time investment. Conclusion. The differences between participants and non-participants in a lifestyle intervention trial are in mainly demographic factors......Background. Non-participants can have a considerable influence on the external validity of a study. Therefore, we assessed the socio-demographic, health-related, and lifestyle behavioral differences between participants and non-participants in a comprehensive CVD lifestyle intervention trial......, and explored the motives and barriers underlying the decision to participate or not. Methods. We collected data on participants (n = 50) and non-participants (n = 50) who were eligible for inclusion in a comprehensive CVD lifestyle interventional trial. Questionnaires and a hospital patient records database...

  16. Are Well-Informed Potential Trial Participants More Likely to Participate?

    Science.gov (United States)

    de Oliveira, Lucas Lentini Herling; Vissoci, Joao Ricardo Nickenig; Machado, Wagner de Lara; Rodrigues, Clarissa G; Limkakeng, Alexander T

    2017-12-01

    Bearing in mind the importance of the informed consent, flaws in this process may be a barrier to participants' recruitment. Our objective was to determine the relationship between the degree of comprehension of the informed consent document plus the importance given to individual elements by potential participants of a hypothetical trial and their willingness to participate in such trials. We performed an Online Survey simulating an emergency department trial recruitment, posteriorly evaluating participants' ratings of importance and self-assessed comprehension of specific topics of the informed consent document. Only 10% of the sample read the entire document. Some specific topics were associated with willingness to participate in the hypothetical trial, but simple composite additive scores of comprehension and importance were not. We concluded that participants in general do not read the entire informed consent document and that importance given to specific topics may influence willingness to participate.

  17. Improving participation rates by providing choice of participation mode: two randomized controlled trials

    NARCIS (Netherlands)

    Heijmans, N.; Lieshout, J. van; Wensing, M.J.

    2015-01-01

    BACKGROUND: Low participation rates reduce effective sample size, statistical power and can increase risk for selection bias. Previous research suggests that offering choice of participation mode can improve participation rates. However, few head-to-head trials compared choice of participation mode

  18. Consent revisited: the impact of return of results on participants' views and expectations about trial participation.

    Science.gov (United States)

    Tarrant, Carolyn; Jackson, Clare; Dixon-Woods, Mary; McNicol, Sarah; Kenyon, Sara; Armstrong, Natalie

    2015-12-01

    Increasingly, the sharing of study results with participants is advocated as an element of good research practice. Yet little is known about how receiving the results of trials may impact on participants' perceptions of their original decision to consent. We explored participants' views of their decision to consent to a clinical trial after they received results showing adverse outcomes in some arms of the trial. Semi-structured interviews were conducted with a purposive sample of 38 women in the UK who participated in a trial of antibiotics in pregnancy. All had received results from a follow-up study that reported increased risk of adverse outcomes for children of participants in some of the trial intervention arms. Data analysis was based on the constant comparative method. Participants' original decisions to consent to the trial had been based on hope of personal benefit and assumptions of safety. On receiving the results, most made sense of their experience in ways that enabled them to remain content with their decision to take part. But for some, the results provoked recognition that their original expectations might have been mistaken or that they had not understood the implications of their decision to participate. These participants experienced guilt, a sense of betrayal by the maternity staff and researchers involved in the trial, and damage to trust. Sharing of study results is not a wholly benign practice, and requires careful development of suitable approaches for further evaluation before widespread adoption. © 2015 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  19. Granulocyte colony-stimulating factor in repeated IVF failure, a randomized trial.

    Science.gov (United States)

    Aleyasin, Ashraf; Abediasl, Zhila; Nazari, Atefeh; Sheikh, Mahdi

    2016-06-01

    Recent studies have revealed key roles for granulocyte colony-stimulating factor (GCSF) in embryo implantation process and maintenance of pregnancy, and some studies showed promising results by using local intrauterine infusion of GCSF in patients undergoing in vitro fertilization (IVF). This multicenter, randomized, controlled trial included 112 infertile women with repeated IVF failure to evaluate the efficacy of systemic single-dose subcutaneous GCSF administration on IVF success in these women. In this study, the Long Protocol of ovarian stimulation was used for all participants. Sealed, numbered envelopes assigned 56 patients to receive subcutaneous 300 µg GCSF before implantation and 56 in the control group. The implantation (number of gestational sacs on the total number of transferred embryos), chemical pregnancy (positive serum β-HCG), and clinical pregnancy (gestational sac and fetal heart) rates were compared between the two groups. This trial is registered at www.irct.ir (IRCT201503119568N11). The successful implantation (18% vs 7.2%, P=0.007), chemical pregnancy (44.6% vs 19.6%, P=0.005), and clinical pregnancy (37.5% vs 14.3%, P=0.005) rates were significantly higher in the intervention group than in the control group. After adjustment for participants' age, endometrial thickness, good-quality oocyte counts, number of transferred embryos, and anti-Mullerian hormone levels, GCSF treatment remained significantly associated with successful implantation (OR=2.63, 95% CI=1.09-6.96), having chemical pregnancy (OR= 2.74, 95% CI=1.11-7.38) and clinical pregnancy (OR=2.94, 95% CI=1.23-8.33). In conclusion, administration of single-dose systemic subcutaneous GCSF before implantation significantly increases the IVF success, implantation, and pregnancy rates in infertile women with repeated IVF failure. © 2016 Society for Reproduction and Fertility.

  20. Clinical trial participation. Viewpoints from racial/ethnic groups.

    Science.gov (United States)

    Roberson, N L

    1994-11-01

    Racial/ethnic groups' participation in clinical trials is a relatively new area of research that warrants attention. Although racial/ethnic groups have been included in experimental studies since the 1940s, they were not included in significant numbers in clinical trials for cancer. Clinical trials play a dominant role in clinical oncology. Despite this state-of-the-art cancer treatment, however, there is mounting concern that this scientific progress is not being shared equitably by all segments of the U.S. population. There is underrepresentation of members of racial/ethnic groups in cancer clinical trials, which suggests that participation may be a critical issue. Unfortunately, little is known or documented about these groups' participation in clinical trials. This paper discusses racial/ethnic groups' views and opinions about clinical trial participation. Diagnostic research was conducted as a beginning phase to investigate this new area of research. African Americans, Hispanics, and Native Americans in three Buffalo, New York, communities were selected as study subjects. Data were collected via telephone surveys. Qualitative methods were employed for data analysis and reporting. Findings showed that study subjects knew little about cancer clinical trials and basically had no opportunity to participate. They believed that participation in clinical trials could be beneficial. In each of the three groups, however, there were cultural factors believed to influence participation. A primary concern was "mistrust of white people" and the feeling of being treated like "guinea pigs." Based on study findings, it was evident that recruitment for improving participation requires strategic planning that involves participants representative of the study population. To yield results, the plan should be tailored to the target group, presented as a credible study, designed to reflect trust in the medical care team, and implemented through a continuous educational process.

  1. Participant recruitment and motivation for participation in optical technology for cervical cancer screening research trials.

    Science.gov (United States)

    Shuhatovich, Olga M; Sharman, Mathilde P; Mirabal, Yvette N; Earle, Nan R; Follen, Michele; Basen-Engquist, Karen

    2005-12-01

    In order to improve recruitment for cervical cancer screening trials, it is necessary to analyze the effectiveness of recruitment strategies used in current trials. A trial to test optical spectroscopy for the diagnosis of cervical neoplasia recruited 1000 women from the community; the trial evaluated the emerging technology against Pap smears and colposcopically directed biopsies for cervical dysplasia. We have examined women's reasons for participating as well as the effectiveness and efficiency for each recruitment strategy. Reasons for participation were identified and compared between trials. The recruitment method that resulted in the most contacts was newspaper reportorial coverage and advertising, followed by family and friends, then television news coverage. The most cost-effective method for finding eligible women who attend the research appointment is word of mouth from a family member or friend. Recommendations are given for maximizing the efficiency of recruitment for cervical cancer screening trials.

  2. Women's experiences of participating in the early external cephalic version 2 trial.

    Science.gov (United States)

    Murray-Davis, Beth; Marion, Anya; Malott, Anne; Reitsma, Angela; Hutton, Eileen K

    2012-03-01

    The international, multicenter External Cephalic Version 2 (ECV2) Trial compared early external cephalic version at 34(0/7) to 35(6/7) weeks with that at greater than 37 weeks. A total of 1,543 women were randomized from 68 centers in 21 countries. The goal of this component of the trial was to understand women's views about participation in a research trial and timing of external cephalic version. A postpartum questionnaire was completed containing a 5-point Likert scale examining contact and availability of staff, choice of timing of external cephalic version, preference of randomization, convenience of participating, and overall satisfaction. Participants also completed two open-ended questions related to timing of external cephalic version and satisfaction with the trial. Descriptive statistics and content analysis were used to analyze data. A total of 1,458 women completed the questionnaire, of whom 86 percent said "yes"-they would participate in the trial again. Themes influencing decisions about participating were perceptions of the external cephalic version experience, preferred mode of delivery, preferred timing of external cephalic version, and perceptions of the effectiveness of external cephalic version and of the trial environment. Many participants preferred the early timing of the procedure offered through the trial because of perceived advantages of a smaller baby being easier to turn and the opportunity for repeat procedures. Women were positive about their participation in the trial. Early external cephalic version was preferred over the traditional timing as it was perceived to afford both physiologic and practical advantages. © 2012, Copyright the Authors. Journal compilation © 2012, Wiley Periodicals, Inc.

  3. Factors influencing participation of psychiatry inpatients in clinical trials.

    Science.gov (United States)

    Mopuru, Nandeeshwar Reddy; Jose, Sam Padamadan; Viswanath, Biju; Kumar, C Naveen; Math, Suresh Bada; Thirthalli, Jagadisha

    2018-02-01

    Serious concerns have arisen in recent years regarding the unethical and illegal practices resorted to during clinical trials. Clinical trials in psychiatry are further complicated by issues such as 'validity of consent' and 'decision making capacity' of patients. This study was planned to explore the factors determining patient participation in clinical trials. A random sample of 123 consenting psychiatry inpatients were provided the information and consent-form of a hypothetical clinical drug trial. They were interviewed regarding their decision, the decision maker and factors that led to the decision. Family members tended to be the decision makers when patients were females, had low-income, were from rural background or had severe illnesses. Anticipated side effects and not wanting to interfere with existing treatment were the common reasons for refusal to participate while hope of betterment of the patient and benefit to humanity were cited for consent. The educated, urban, affluent class had more awareness regarding unethical trials and tended to be mistrustful of the medical community leading to higher rates of non-participation. Those who were adherent with ongoing treatment were also unwilling to participate. The lesser educated, low-income patients and rural domicile patients on the other hand had lesser awareness regarding clinical trials, trusted doctors and were more likely to participate. A good doctor-patient relationship, detailed explanations and clarification regarding the study and its conduct, and building awareness regarding clinical trials among vulnerable groups is necessary to ensure a valid consent involving no coercion, removal of prejudices, and ethical conduct of trials. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

    Science.gov (United States)

    Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

    2018-03-01

    Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

  5. Sharing and reuse of individual participant data from clinical trials

    DEFF Research Database (Denmark)

    Ohmann, Christian; Banzi, Rita; Canham, Steve

    2017-01-01

    : The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need......OBJECTIVES: We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. DESIGN AND METHODS: This was a consensus...... Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European. OUTCOME: We developed principles and practical recommendations on how to share data...

  6. Clinical trial participant characteristics and saliva and DNA metrics

    Directory of Open Access Journals (Sweden)

    Richards Julie

    2009-10-01

    Full Text Available Abstract Background Clinical trial and epidemiological studies need high quality biospecimens from a representative sample of participants to investigate genetic influences on treatment response and disease. Obtaining blood biospecimens presents logistical and financial challenges. As a result, saliva biospecimen collection is becoming more frequent because of the ease of collection and lower cost. This article describes an assessment of saliva biospecimen samples collected through the mail, trial participant demographic and behavioral characteristics, and their association with saliva and DNA quantity and quality. Methods Saliva biospecimens were collected using the Oragene® DNA Self-Collection Kits from participants in a National Cancer Institute funded smoking cessation trial. Saliva biospecimens from 565 individuals were visually inspected for clarity prior to and after DNA extraction. DNA samples were then quantified by UV absorbance, PicoGreen®, and qPCR. Genotyping was performed on 11 SNPs using TaqMan® SNP assays and two VNTR assays. Univariate, correlation, and analysis of variance analyses were conducted to observe the relationship between saliva sample and participant characteristics. Results The biospecimen kit return rate was 58.5% among those invited to participate (n = 967 and 47.1% among all possible COMPASS participants (n = 1202. Significant gender differences were observed with males providing larger saliva volume (4.7 vs. 4.5 ml, p = 0.019, samples that were more likely to be judged as cloudy (39.5% vs. 24.9%, p 0.21, P Conclusion Findings from this study show that demographic and behavioral characteristics of smoking cessation trial participants have significant associations with saliva and DNA metrics, but not with the performance of TaqMan® SNP or VNTR genotyping assays. Trial registration COMPASS; registered as NCT00301145 at clinicaltrials.gov.

  7. Benefits and Burdens of Participation in a Longitudinal Clinical Trial

    Science.gov (United States)

    Lazovski, Jaime; Losso, Marcelo; Krohmal, Benjamin; Emanuel, Ezekiel J.; Grady, Christine; Wendler, David

    2010-01-01

    systematic data on the impact that longitudinal clinical trials have on patient participants are needed to ensure that all the risks and potential benefits of participating in clinical research are properly evaluated and disclosed. Recognizing the lack of systematic data on this topic, we surveyed 582 individuals from Argentina, Brazil, and Thailand who were participating in the ESPRIT study, a Phase III randomized trial of interleukin-2 in HIV disease. Respondents were asked about the benefits and burdens of participating in ESPRIT using a self-administered survey. We found that 91% of respondents in the IL-2 treatment arm and 79% in the no IL-2 control arm reported medical benefits from their participation. In addition, 68% in the IL-2 treatment arm and 60% of the no IL-2 controls reported non-medical benefits. Thirteen percent of the IL-2 respondents and 5% of the non-IL2 respondents reported problems with their jobs due to study participation. Given that respondents, including those in the control arm, reported medical and non-medical benefits and burdens from their research participation, investigators and review committees should be aware of and respond to the potential for research participants to experience benefits and burdens that are unrelated to the intervention being tested. PMID:19754238

  8. Repeated tender point injections of granisetron alleviate chronic myofascial pain--a randomized, controlled, double-blinded trial.

    Science.gov (United States)

    Christidis, Nikolaos; Omrani, Shahin; Fredriksson, Lars; Gjelset, Mattias; Louca, Sofia; Hedenberg-Magnusson, Britt; Ernberg, Malin

    2015-01-01

    Serotonin (5-HT) mediates pain by peripheral 5-HT3-receptors. Results from a few studies indicate that intramuscular injections of 5-HT3-antagonists may reduce musculoskeletal pain. The aim of this study was to investigate if repeated intramuscular tender-point injections of the 5-HT3-antagonist granisetron alleviate pain in patients with myofascial temporomandibular disorders (M-TMD). This prospective, randomized, controlled, double blind, parallel-arm trial (RCT) was carried out during at two centers in Stockholm, Sweden. The randomization was performed by a researcher who did not participate in data collection with an internet-based application ( www.randomization.com ). 40 patients with a diagnose of M-TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) were randomized to receive repeated injections, one week apart, with either granisetron (GRA; 3 mg) or isotonic saline as control (CTR). The median weekly pain intensities decreased significantly at all follow-ups (1-, 2-, 6-months) in the GRA-group (Friedman test; P  0.075). The numbers needed to treat (NNT) were 4 at the 1- and 6-month follow-ups, and 3.3 at the 2-month follow-up in favor of granisetron. Repeated intramuscular tender-point injections with granisetron provide a new pharmacological treatment possibility for myofascial pain patients with repeated intramuscular tender-point injections with the serotonin type 3 antagonist granisetron. It showed a clinically relevant pain reducing effect in the temporomandibular region, both in a short- and long-term aspect. European Clinical Trials Database 2005-006042-41 as well as at Clinical Trials NCT02230371 .

  9. Permitting patients to pay for participation in clinical trials: the advent of the P4 trial.

    Science.gov (United States)

    Shaw, David; de Wert, Guido; Dondorp, Wybo; Townend, David; Bos, Gerard; van Gelder, Michel

    2017-06-01

    In this article we explore the ethical issues raised by permitting patients to pay for participation (P4) in clinical trials, and discuss whether there are any categorical objections to this practice. We address key considerations concerning payment for participation in trials, including patient autonomy, risk/benefit and justice, taking account of two previous critiques of the ethics of P4. We conclude that such trials could be ethical under certain strict conditions, but only if other potential sources of funding have first been explored or are unavailable.

  10. Motivators to participation in actual HIV vaccine trials.

    Science.gov (United States)

    Dhalla, Shayesta; Poole, Gary

    2014-02-01

    An examination of actual HIV vaccine trials can contribute to an understanding of motivators for participation in these studies. Analysis of these motivators reveals that they can be categorized as social and personal benefits. Social benefits are generally altruistic, whereas personal benefits are psychological, physical, and financial. In this systematic review, the authors performed a literature search for actual preventive HIV vaccine trials reporting motivators to participation. Of studies conducted in the Organization for Economic Co-operation and Development (OECD) countries, the authors retrieved 12 studies reporting on social benefits and seven reporting on personal benefits. From the non-OECD countries, nine studies reported on social benefits and eight studies on personal benefits. Social benefits were most frequently described on macroscopic, altruistic levels. Personal benefits were most frequently psychological in nature. Rates of participation were compared between the OECD and the non-OECD countries. Knowledge of actual motivators in specific countries and regions can help target recruitment in various types of actual HIV vaccine trials.

  11. Clinical trials: the challenge of recruitment and retention of participants.

    Science.gov (United States)

    Gul, Raisa B; Ali, Parveen A

    2010-01-01

    This article, based on the available literature, attempts to discuss the importance of recruitment and retention of research participants, the associated barriers and challenges, and various strategies to overcome these barriers. The inability to recruit and retain the required participants in a research project poses serious threats to both the internal and the external validity of a research study. Despite serious implications, the issues of recruitment and retention do not receive due attention in research and publications. Literature suggests a lack of coordinated efforts to collect information on the outcomes of recruitment experiences in clinical trials and population studies. Studies often mention the number of participants who refuse to participate; however, the majority of the studies often fail to mention the specific reasons insufficient recruitment or retention of the participants. A methodological paper. Various participant-, context-, environment- and research-related factors are examined that affect the phenomenon of recruitment and retention of the participants in a study. Delayed or inefficient recruitment also has financial and ethical implications. Although there are many pieces of information scattered throughout academic journals on recruitment and retention of participants in research, few authors have dealt with the issue holistically. It is imperative for researchers to understand the importance of recruitment and retention of research participants, the associated barriers and challenges, and various strategies to overcome these barriers. Appropriate recording and reporting of the problems faced while recruiting and retaining the participants in research studies can help not only in understating the challenge, but will also help in devising the strategies to overcome this problem. This article was an attempt to synthesise and review the available literature on recruitment and retention issues, which demand extensive theoretical and

  12. A randomized trial of motivational interviewing and facilitated contraceptive access to prevent rapid repeat pregnancy among adolescent mothers.

    Science.gov (United States)

    Stevens, Jack; Lutz, Robyn; Osuagwu, Ngozi; Rotz, Dana; Goesling, Brian

    2017-10-01

    Most interventions designed to reduce teen pregnancy rates have not focused on pregnant and/or parenting adolescents. Therefore, a large randomized controlled trial was conducted regarding a motivational interviewing program entitled Teen Options to Prevent Pregnancy in a low-income sample of adolescent mothers. This program recommended monthly sessions between a participant and a registered nurse over 18 months. This program also featured facilitated birth control access through transportation assistance and a part-time contraceptive clinic. The impact of this program on rapid repeat pregnancies at 18 months after enrollment was evaluated. Five hundred ninety-eight adolescent females were enrolled from 7 obstetrics-gynecology clinics and 5 postpartum units of a large hospital system in a Midwestern city. Each participant was enrolled at least 28 weeks pregnant or less than 9 weeks postpartum. Each participant was randomized to either the Teen Options to Prevent Pregnancy intervention or a usual-care control condition. Intervention participants averaged 4.5 hours of assistance. Participants were contacted by blinded research staff at 6 and 18 months to complete self-report surveys. Differences in outcomes between the intervention and control groups were assessed using ordinary least-squares regression. There was an 18.1% absolute reduction in self-reported repeat pregnancy in the intervention group relative to the control group (20.5% vs 38.6%%; P Teen Options to Prevent Pregnancy program represents one of the few evidence-based interventions to reduce rapid repeat teen pregnancy. This relatively brief intervention may be a viable alternative to more time-intensive programs that adolescent mothers may be unable or unwilling to receive. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

    Science.gov (United States)

    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  14. Impact of depressive symptoms, self-esteem and neuroticism on trajectories of overgeneral autobiographical memory over repeated trials.

    Science.gov (United States)

    Kashdan, Todd B; Roberts, John E; Carlos, Erica L

    2006-04-01

    The present study examined trajectories of change in the frequency of overgeneral autobiographical memory (OGM) over the course of repeated trials, and tested whether particular dimensions of depressive symptomatology (somatic and cognitive-affective distress), self-esteem, and neuroticism account for individual differences in these trajectories. Given that depression is associated with impairments in effortful processing, we predicted that over repeated trials depression would be associated with increasingly OGM. Generalised Linear Mixed Models with Penalised Quasi-Likelihood demonstrated significant linear and quadratic trends in OGM over repeated trials, and somatic distress and self-esteem moderated these slopes. The form of these interactions suggested that somatic distress and low self-esteem primarily contribute to OGM during the second half of the trial sequence. The present findings demonstrate the value of a novel analytical approach to OGM that estimates individual trajectories of change over repeated trials.

  15. Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative

    Directory of Open Access Journals (Sweden)

    Rachel G. Greenberg

    2018-03-01

    In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

  16. Physician participation in clinical research and trials: issues and approaches

    Directory of Open Access Journals (Sweden)

    Sami F Shaban

    2011-03-01

    research culture’. This article examines the barriers to and benefits of physician participation in clinical research as well as interventions needed to increase their participation, including the specific role of undergraduate medical education. The main challenge is the unwillingness of many physicians and patients to participate in clinical trials. Barriers to participation include lack of time, lack of resources, trial-specific issues, communication difficulties, conflicts between the role of clinician and scientist, inadequate research experience and training for physicians, lack of rewards and recognition for physicians, and sometimes a scientifically uninteresting research question, among others. Strategies to encourage physician participation in clinical research include financial and nonfinancial incentives, adequate training, research questions that are in line with physician interests and have clear potential to improve patient care, and regular feedback. Finally, encouraging research culture and fostering the development of inquiry and research-based learning among medical students is now a high priority in order to develop more and better clinician-researchers.Keywords: physician, clinical research, clinical trial, medical education

  17. Participant verification: Prevention of co‑enrolment in clinical trials in ...

    African Journals Online (AJOL)

    Methods. The Medical Research Council (MRC) HIV Prevention Research ... which uses fingerprint-based biometric technology to identify participants. ... and clinical trial sites, with new participant information loaded at first visit to a trial site.

  18. Repeat prenatal corticosteroid prior to preterm birth: a systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: assessing the effects using the best level of evidence - study protocol

    Directory of Open Access Journals (Sweden)

    Crowther Caroline A

    2012-02-01

    Full Text Available Abstract Background The aim of this individual participant data (IPD meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol. Methods/Design The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant; severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4; chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia; use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support; and birth weight (Z-scores. For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean, cerebral palsy (abnormality of tone with motor dysfunction, blindness (for example, corrected visual acuity worse than 6/60 in the better eye or deafness (for example, hearing loss requiring amplification or worse. For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use

  19. Rationale and design of REACT: a randomised controlled trial assessing the effectiveness of home-collection to increase chlamydia retesting and detect repeat positive tests.

    Science.gov (United States)

    Smith, Kirsty S; Hocking, Jane S; Chen, Marcus; Fairley, Christopher K; McNulty, Anna; Read, Phillip; Bradshaw, Catriona S; Tabrizi, Sepehr N; Wand, Handan; Saville, Marion; Rawlinson, William; Garland, Suzanne M; Donovan, Basil; Kaldor, John M; Guy, Rebecca

    2014-04-24

    Repeat infection with Chlamydia trachomatis is common and increases the risk of sequelae in women and HIV seroconversion in men who have sex with men (MSM). Despite guidelines recommending chlamydia retesting three months after treatment, retesting rates are low. We are conducting the first randomised controlled trial to assess the effectiveness of home collection combined with short message service (SMS) reminders on chlamydia retesting and reinfection rates in three risk groups. The REACT (retest after Chlamydia trachomatis) trial involves 600 patients diagnosed with chlamydia: 200 MSM, 200 women and 200 heterosexual men recruited from two Australian sexual health clinics where SMS reminders for retesting are routine practice. Participants will be randomised to the home group (3-month SMS reminder and home-collection) or the clinic group (3-month SMS reminder to return to the clinic). Participants in the home group will be given the choice of attending the clinic if they prefer. The mailed home-collection kit includes a self-collected vaginal swab (women), UriSWAB (Copan) for urine collection (heterosexual men), and UriSWAB plus rectal swab (MSM). The primary outcome is the retest rate at 1-4 months after a chlamydia diagnosis, and the secondary outcomes are: the repeat positive test rate; the reinfection rate; the acceptability of home testing with SMS reminders; and the cost effectiveness of home testing. Sexual behaviour data collected via an online survey at 4-5 months, and genotyping of repeat infections, will be used to discriminate reinfections from treatment failures. The trial will be conducted over two years. An intention to treat analysis will be conducted. This study will provide evidence about the effectiveness of home-collection combined with SMS reminders on chlamydia retesting, repeat infection and reinfection rates in three risk groups. The trial will determine client acceptability and cost effectiveness of this strategy. Australian and New

  20. Effects of rearing environment and population origin on responses to repeated behavioural trials in cane toads (Rhinella marina).

    Science.gov (United States)

    Gruber, Jodie; Whiting, Martin J; Brown, Gregory; Shine, Richard

    2018-05-02

    Behavioural response to repeated trials in captivity can be driven by many factors including rearing environment, population of origin, habituation to captivity/trial conditions and an individual's behavioural type (e.g., bold versus shy). We tested the effect of rearing environment (captive raised common-garden versus wild-caught) and population origin (range-edge versus range-front) on the responses of invasive cane toads (Rhinella marina) to repeated exploration and risk-taking assays in captivity. We found that behavioural responses to identical assays performed on two occasions were complex and showed few consistent patterns based on rearing environment or population of origin. However, behavioural traits were repeatable across Trial Blocks when all sample populations were grouped together, indicating general consistency in individual toad behaviour across repeated behavioural assays. Our findings exemplify the complexity and unpredictability of behavioural responses and their effects on the repeatability and interpretation of behavioural traits across repeated behavioural assays in captivity. To meaningfully interpret the results from repeated behavioural assays, we need to consider how multiple factors may affect behavioural responses to these tests and importantly, how these responses may affect the repeatability of behavioural traits across time. Copyright © 2018. Published by Elsevier B.V.

  1. Non-participants and reasons for non-participation in a pragmatic trial of energy healing as cancer rehabilitation

    DEFF Research Database (Denmark)

    Techau, Marzcia Elisa Camille; Lunde, Anita; Pedersen, Christina Gundgaard

    2014-01-01

    Introduction: The problems associated with clinical trial participation have been highlighted in the literature, but few studies have examined why patients decline to participate. Aims: To describe non-participants' and participants' characteristics and examine reasons for non-participation in a ......Introduction: The problems associated with clinical trial participation have been highlighted in the literature, but few studies have examined why patients decline to participate. Aims: To describe non-participants' and participants' characteristics and examine reasons for non......-participation in a pragmatic trial of energy healing for rehabilitation for colorectal cancer. Methods: Three to seven days after postal recruitment, all eligible participants (n=783) were contacted by telephone. Reasons given for non-participation were recorded in 5 categories. Data were analyzed using Chi2. Results: More.......001). The most frequent reasons for non-participation were (1) No need for rehabilitation (n=81; 28.6%), (2) participation too burdensome (n=67; 23.7%), and (3) no interest in energy healing (n=57; 20.1%). If the time span between study recruitment and surgery was 0-9 months, participation was frequently...

  2. Longitudinal predictors of colorectal cancer screening among participants in a randomized controlled trial.

    Science.gov (United States)

    Murphy, Caitlin C; Vernon, Sally W; Haddock, Nicole M; Anderson, Melissa L; Chubak, Jessica; Green, Beverly B

    2014-09-01

    Few studies use longitudinal data to identify predictors of colorectal cancer screening (CRCS). We examined predictors of (1) initial CRCS during the first year of a randomized trial, and (2) repeat CRCS during the second year of the trial among those that completed FOBT in Year 1. The sample comprised 1247 participants of the Systems of Support to Increase Colorectal Cancer Screening (SOS) Trial (Group Health Cooperative, August 2008 to November 2011). Potential predictors of CRCS were identified with logistic regression and included sociodemographics, health history, and validated scales of psychosocial constructs. Prior CRCS (OR 2.64, 95% CI 1.99-3.52) and intervention group (Automated: OR 2.06 95% CI 1.43-2.95; Assisted: OR 4.03, 95% CI 2.69-6.03; Navigated: OR 5.64, 95% CI 3.74-8.49) were predictors of CRCS completion at Year 1. For repeat CRCS at Year 2, prior CRCS at baseline (OR 1.97, 95% CI 1.25-3.11), intervention group (Automated: OR 9.27, 95% CI 4.56-18.82; Assisted: OR 11.17, 95% CI 5.44-22.94; Navigated: OR 13.10, 95% CI 6.33-27.08), and self-efficacy (OR 1.32, 95% CI 1.00-1.73) were significant predictors. Self-efficacy and prior CRCS are important predictors of future screening behavior. CRCS completion increased when access barriers were removed through interventions. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. Reasons for participating in a randomised clinical trial: The volunteers' voices in the COSTOP trial in Uganda

    Directory of Open Access Journals (Sweden)

    Agnes Ssali

    2017-09-01

    Full Text Available Introduction: The reasons why research participants join clinical trials remains an area of inquiry especially in low and middle income countries. Methods: We conducted exit interviews with participants who took part in a trial which aimed to evaluate whether long term prophylaxis with cotrimoxazole can be safely discontinued among adults who have been stabilised on antiretroviral therapy (ART. Participants were all reported to be stable on ART and had been participating in the trial for between 12 and 36 months; at the end of the trial participants were interviewed using a semi-structured questionnaire. One of the objectives of the exit interview was to find out what motivated the participants to join the research. Results: Participants gave personal reasons for joining the trial, frequently linked to their health and well-being as well as reduction of pill burden. Conclusion: We conclude that underlying reasons for joining clinical trials may extend beyond or can be different from the rationale given to the participants before enrolment by the research team. The reasons that motivate enrolment to clinical trials and research in general require further investigation in different settings. Trial registration number: ISRCTN44723643. Keywords: Randomised clinical trials, Volunteers, Participants

  4. Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative

    Directory of Open Access Journals (Sweden)

    Rachel G. Greenberg

    2018-03-01

    Of the 136 providers surveyed, 52/136 (38% had previously referred a pediatric patient to a trial, and only 17/136 (12% had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.

  5. Personalized Video Feedback and Repeated Task Practice Improve Laparoscopic Knot-Tying Skills: Two Controlled Trials.

    Science.gov (United States)

    Abbott, Eduardo F; Thompson, Whitney; Pandian, T K; Zendejas, Benjamin; Farley, David R; Cook, David A

    2017-11-01

    Compare the effect of personalized feedback (PF) vs. task demonstration (TD), both delivered via video, on laparoscopic knot-tying skills and perceived workload; and evaluate the effect of repeated practice. General surgery interns and research fellows completed four repetitions of a simulated laparoscopic knot-tying task at one-month intervals. Midway between repetitions, participants received via e-mail either a TD video (demonstration by an expert) or a PF video (video of their own performance with voiceover from a blinded senior surgeon). Each participant received at least one video per format, with sequence randomly assigned. Outcomes included performance scores and NASA Task Load Index (NASA-TLX) scores. To evaluate the effectiveness of repeated practice, scores from these trainees on a separate delayed retention test were compared against historical controls who did not have scheduled repetitions. Twenty-one trainees completed the randomized study. Mean change in performance scores was significantly greater for those receiving PF (difference = 23.1 of 150 [95% confidence interval (CI): 0, 46.2], P = .05). Perceived workload was also significantly reduced (difference = -3.0 of 20 [95% CI: -5.8, -0.3], P = .04). Compared with historical controls (N = 93), the 21 with scheduled repeated practice had higher scores on the laparoscopic knot-tying assessment two weeks after the final repetition (difference = 1.5 of 10 [95% CI: 0.2, 2.8], P = .02). Personalized video feedback improves trainees' procedural performance and perceived workload compared with a task demonstration video. Brief monthly practice sessions support skill acquisition and retention.

  6. Shedding light on research participation effects in behaviour change trials: a qualitative study examining research participant experiences.

    Science.gov (United States)

    MacNeill, Virginia; Foley, Marian; Quirk, Alan; McCambridge, Jim

    2016-01-29

    The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants' experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomes Twenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption) and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach. The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants' relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes. These participants described no dramatic impacts attributable to taking part in

  7. Community perceptions of repeat HIV-testing: experiences of the ANRS 12249 Treatment as Prevention trial in rural South Africa.

    Science.gov (United States)

    Orne-Gliemann, Joanna; Zuma, Thembelihle; Chikovore, Jeremiah; Gillespie, Natasha; Grant, Merridy; Iwuji, Collins; Larmarange, Joseph; McGrath, Nuala; Lert, France; Imrie, John

    2016-01-01

    In the context of the ANRS 12249 Treatment as Prevention (TasP) trial, we investigated perceptions of regular and repeat HIV-testing in rural KwaZulu-Natal (South Africa), an area of very high HIV prevalence and incidence. We conducted two qualitative studies, before (2010) and during the early implementation stages of the trial (2013-2014), to appreciate the evolution in community perceptions of repeat HIV-testing over this period of rapid changes in HIV-testing and treatment approaches. Repeated focus group discussions were organized with young adults, older adults and mixed groups. Repeat and regular HIV-testing was overall well perceived before, and well received during, trial implementation. Yet community members were not able to articulate reasons why people might want to test regularly or repeatedly, apart from individual sexual risk-taking. Repeat home-based HIV-testing was considered as feasible and convenient, and described as more acceptable than clinic-based HIV-testing, mostly because of privacy and confidentiality. However, socially regulated discourses around appropriate sexual behaviour and perceptions of stigma and prejudice regarding HIV and sexual risk-taking were consistently reported. This study suggests several avenues to improve HIV-testing acceptability, including implementing diverse and personalised approaches to HIV-testing and care, and providing opportunities for antiretroviral therapy initiation and care at home.

  8. Effect of race/ethnicity on participation in HIV vaccine trials and comparison to other trials of biomedical prevention.

    Science.gov (United States)

    Dhalla, Shayesta; Poole, Gary

    2014-01-01

    Racial/ethnic minorities are underrepresented in actual HIV vaccine trials in North America, and willingness to participate (WTP) and retention in an HIV vaccine trial may differ from that in Whites. In this review, the authors identified HIV vaccine preparedness studies (VPS) in North America in high-risk populations that examined the relationship between race/ethnicity and WTP in a preventive phase 3 HIV vaccine trial, and the relationship to retention. Studies were categorized by risk group, and comparison group (Whites vs. non-Whites). Other types of trials of biomedical prevention were also identified, and WTP and retention rates were compared and contrasted to actual HIV vaccine trials. In the studies identified, WTP in a hypothetical trial HIV vaccine trial did not differ by race/ethnicity. In contrast, actual HIV vaccine trials, an HIV acquisition trial, and a phase 2B preexposure prophylaxis (PrEP) trial have enrolled a large percentage of White men. Human papilloma virus (HPV) privately-funded trials have also enrolled a large number of Whites, due to convenience sampling. Retention in the HIV acquisition trial was lower in African-Americans compared with Whites. Strategies to increase WTP and enhanced retention (ER) strategies may help in recruiting and retaining minority participants in actual HIV vaccine trials and other trials of biomedical prevention.

  9. Shedding light on research participation effects in behaviour change trials: a qualitative study examining research participant experiences

    Directory of Open Access Journals (Sweden)

    Virginia MacNeill

    2016-01-01

    Full Text Available Abstract Background The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants’ experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomes Methods Twenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach. Results The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants’ relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes. Conclusion These

  10. "I will miss the study, God bless you all": participation in a nutritional chemoprevention trial.

    Science.gov (United States)

    Moreno-Black, Geraldine; Shor-Posner, Gail; Miguez, Maria-Jose; Burbano, Ximena; O'Mellan, Sandra; Yovanoff, P

    2004-01-01

    Randomized controlled clinical trials are often considered to be the "gold standard" for health research. Consequently, understanding the reasons people participate in these trials, especially minority groups who are often under-represented in clinical trials, or populations who have chronic illnesses or abuse drugs, is salient for successful recruitment, retention, and project design. This paper describes the results of a study that was designed to examine some of the ways in which participants in a randomized double blind clinical trial perceived their participation in the clinical trial, and the reasons they gave for continuing in the study. All of the participants were individuals who were using drugs and were infected with the HIV-1 virus, and had participated in a chemoprevention trial. The data from an exit interview were analyzed thematically in order to reveal units of meaning concerning participation and continuation in the clinical trial. The analysis revealed 3 higher-level concepts, or themes, that guided participation: increased health awareness, personal enhancement, and sociability. The data clearly indicated that involvement and retention in the trial were directly related to the ways in which the participants interpreted the study, perceived the benefits they derived from participating, and imbued their participation with value so that it was important and relevant to their own perceptions of health, as well as personal and social well being.

  11. Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative.

    Science.gov (United States)

    Greenberg, Rachel G; Corneli, Amy; Bradley, John; Farley, John; Jafri, Hasan S; Lin, Li; Nambiar, Sumathi; Noel, Gary J; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

    2018-03-01

    Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recruitment of pediatric patients, but little is known regarding the specific barriers that limit pediatric providers from participating in and referring their patients to clinical trials. We conducted an online survey of pediatric providers from a wide variety of practice types across the United States to evaluate their attitudes and awareness of pediatric clinical trials. Using a 4-point Likert scale, providers described their perception of potential barriers to their practice serving as a site for pediatric clinical trials. Of the 136 providers surveyed, 52/136 (38%) had previously referred a pediatric patient to a trial, and only 17/136 (12%) had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.

  12. Elective repeat cesarean delivery compared with trial of labor after a prior cesarean delivery: a propensity score analysis

    NARCIS (Netherlands)

    Kok, N.; Ruiter, L.; Lindeboom, R.; de Groot, C.; Pajkrt, E.; Mol, B. W.; Kazemier, B. M.

    2015-01-01

    To determine neonatal and short term maternal outcomes according to intentional mode of delivery following a cesarean delivery (CD). Women pregnant after CD between January 2000 and December 2007 were categorized according to whether they had an elective repeat CD (ERCD) or a Trial of Labor (TOL).

  13. Transparency and public accessibility of clinical trial information in Croatia: how it affects patient participation in clinical trials.

    Science.gov (United States)

    Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana

    2017-06-15

    Despite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. We assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients' associations. Despite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. Our study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.

  14. "In God we trust" and other factors influencing trial of labor versus Repeat cesarean section.

    Science.gov (United States)

    Pomeranz, Meir; Arbib, Nissim; Haddif, Limor; Reissner, Hana; Romem, Yitzhak; Biron, Tal

    2018-07-01

    To investigate factors influencing women's decisions to undergo trial of labor after cesarean (TOLAC) or elective repeat cesarean delivery (ERCD) based on the Multidimensional Health Locus of Control (MHLC), religious observance and family planning. Cross-sectional study of candidates for TOLAC or ERCD at two hospitals in Israel. Eligible women completed a demographic questionnaire and Form C of the MHLC scale. The study included 197 women. Those who chose TOLAC (N = 101) were more religiously observant, wanted more children and had higher Internal and Chance health locus of control. Women who chose ERCD (N = 96) were more likely to be secular and had a higher health locus of control influenced by Powerful Others, notably physicians. Women not influenced by others were more likely to choose TOLAC. A woman's choice of TOLAC or ERCD is influenced by her sense of control over her health, degree of religious observance and number of children desired. Healthcare providers can use this information to better understand, counsel and educate women regarding appropriate delivery decisions. Women who feel in control of their health, educated about delivery options and are less influenced by provider preference, might choose TOLAC; thus, reducing the rate of unnecessary ERCD.

  15. Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.

    Science.gov (United States)

    Tang, Chad; Hess, Kenneth R; Sanders, Dwana; Davis, Suzanne E; Buzdar, Aman U; Kurzrock, Razelle; Lee, J Jack; Meric-Bernstam, Funda; Hong, David S

    2017-03-15

    Purpose: Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center (Houston, TX) and analyzed their effects on the trial activation timeline and enrolment. Experimental Design: Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database, we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results: We identified three facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship [industry (133 ICT and 133 non-ICT trials) or institutional (68 ICT and 68 non-ICT trials)]. ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrolment (median difference of 0.3 months for industry vs. 1.2 months for institutional; all matched P infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. Clin Cancer Res; 23(6); 1407-13. ©2016 AACR . ©2016 American Association for Cancer Research.

  16. Participant verification: prevention of co-enrolment in clinical trials in South Africa.

    Science.gov (United States)

    Harichund, C; Haripersad, K; Ramjee, R

    2013-05-15

    As KwaZulu-Natal Province is the epicentre of the HIV epidemic in both South Africa (SA) and globally, it is an ideal location to conduct HIV prevention and therapeutic trials. Numerous prevention trials are currently being conducted here; the potential for participant co-enrolment may compromise the validity of these studies and is therefore of great concern. To report the development and feasibility of a digital, fingerprint-based participant identification method to prevent co-enrolment at multiple clinical trial sites. The Medical Research Council (MRC) HIV Prevention Research Unit (HPRU) developed the Biometric Co-enrolment Prevention System (BCEPS), which uses fingerprint-based biometric technology to identify participants. A trial website was used to determine the robustness and usability of the system. After successful testing, the BCEPS was piloted in July 2010 across 7 HPRU clinical research sites. The BCEPS was pre-loaded with study names and clinical trial sites, with new participant information loaded at first visit to a trial site. We successfully implemented the BCEPS at the 7 HPRU sites. Using the BCEPS, we performed real-time 'flagging' of women who were already enrolled in another study as they entered a trial at an HPRU site and, where necessary, excluded them from participation on site. This system has promise in reducing co-enrolment in clinical trials and represents a valuable tool for future implementation by all groups conducting trials. The MRC is currently co-ordinating this effort with clinical trial sites nationally.

  17. Adolescent decision making about participation in a hypothetical HIV vaccine trial.

    Science.gov (United States)

    Alexander, Andreia B; Ott, Mary A; Lally, Michelle A; Sniecinski, Kevin; Baker, Alyne; Zimet, Gregory D

    2015-03-10

    The purpose of this study was to examine the process of adolescent decision-making about participation in an HIV vaccine clinical trial, comparing it to adult models of informed consent with attention to developmental differences. As part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16-19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their decision making process when deciding whether or not to enroll in and HIV vaccine trial. An ethnographic content analysis approach was utilized. Twelve concepts related to adolescents' decision-making about participation in an HIV vaccine trial were identified and mapped onto Appelbaum and Grisso's four components of decision making capacity including understanding of vaccines and how they work, the purpose of the study, trial procedures, and perceived trial risks and benefits, an appreciation of their own situation, the discussion and weighing of risks and benefits, discussing the need to consult with others about participation, motivations for participation, and their choice to participate. The results of this study suggest that most adolescents at high risk for HIV demonstrate the key abilities needed to make meaningful decisions about HIV vaccine clinical trial participation. Published by Elsevier Ltd.

  18. Lessons in participant retention in the course of a randomized controlled clinical trial.

    Science.gov (United States)

    Idoko, Olubukola T; Owolabi, Olumuyiwa A; Odutola, Aderonke A; Ogundare, Olatunde; Worwui, Archibald; Saidu, Yauba; Smith-Sanneh, Alison; Tunkara, Abdoulie; Sey, Gibbi; Sanyang, Assan; Mendy, Philip; Ota, Martin O C

    2014-10-09

    Clinical trials are increasingly being conducted as new products seek to enter the market. Deployment of such interventions is based on evidence obtained mainly from the gold standard of randomized controlled clinical trials (RCCT). A crucial factor in the ability of RCCTs to provide credible and generalisable data is sample size and retention of the required number of subjects at completion of the follow-up period. However, recruitment and retention in clinical trials are hindered by prevalent peculiar challenges in Africa that need to be circumvented. This article shares experiences from a phase II trial that recorded a high retention rate at 14 months follow-up at a new clinical trial site. Mothers bringing children less than two months of age to the health facility were given information and invited to have their child enrolled if the inclusion criteria were fulfilled. Participants were enrolled over 8 months. Trial procedures, duration and risks/benefits were painstakingly and sequentially explained to the communities, parents and relevant relatives before and during the trial period. The proportions of participants that completed or did not complete the trial were analyzed including the reasons for failure to complete all trial procedures. 1044 individuals received information regarding the trial of which 371 returned for screening. 300 (81%) of them who fulfilled the inclusion criteria and did not meet any exclusion criteria were enrolled and 94% of these completed the trial. Consent withdrawal was the main reason for not completing the trial largely (75%) due to the father not being involved at the point of consenting or parents no longer being comfortable with blood sampling. Participant retention in clinical trials remains a crucial factor in ensuring generalisability of trial data. Appropriate measures to enhance retention should include continuous community involvement in the process, adequate explanation of trial procedures and risks/benefits; and

  19. Ingestion of High Molecular Weight Carbohydrate Enhances Subsequent Repeated Maximal Power: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Jonathan M Oliver

    Full Text Available Athletes in sports demanding repeat maximal work outputs frequently train concurrently utilizing sequential bouts of intense endurance and resistance training sessions. On a daily basis, maximal work within subsequent bouts may be limited by muscle glycogen availability. Recently, the ingestion of a unique high molecular weight (HMW carbohydrate was found to increase glycogen re-synthesis rate and enhance work output during subsequent endurance exercise, relative to low molecular weight (LMW carbohydrate ingestion. The effect of the HMW carbohydrate, however, on the performance of intense resistance exercise following prolonged-intense endurance training is unknown. Sixteen resistance trained men (23±3 years; 176.7±9.8 cm; 88.2±8.6 kg participated in a double-blind, placebo-controlled, randomized 3-way crossover design comprising a muscle-glycogen depleting cycling exercise followed by ingestion of placebo (PLA, or 1.2 g•kg•bw-1 of LMW or HMW carbohydrate solution (10% with blood sampling for 2-h post-ingestion. Thereafter, participants performed 5 sets of 10 maximal explosive repetitions of back squat (75% of 1RM. Compared to PLA, ingestion of HMW (4.9%, 90%CI 3.8%, 5.9% and LMW (1.9%, 90%CI 0.8%, 3.0% carbohydrate solutions substantially increased power output during resistance exercise, with the 3.1% (90% CI 4.3, 2.0% almost certain additional gain in power after HMW-LMW ingestion attributed to higher movement velocity after force kinematic analysis (HMW-LMW 2.5%, 90%CI 1.4, 3.7%. Both carbohydrate solutions increased post-exercise plasma glucose, glucoregulatory and gut hormones compared to PLA, but differences between carbohydrates were unclear; thus, the underlying mechanism remains to be elucidated. Ingestion of a HMW carbohydrate following prolonged intense endurance exercise provides superior benefits to movement velocity and power output during subsequent repeated maximal explosive resistance exercise. This study was registered

  20. Tracking and tracing of participants in two large cancer screening trials.

    Science.gov (United States)

    Marcus, Pamela M; Childs, Jeffery; Gahagan, Betsy; Gren, Lisa H

    2012-07-01

    Many clinical trials rely on participant report to first learn about study events. It is therefore important to have current contact information and the ability to locate participants should information become outdated. The Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) and the Lung Screening Study (LSS) component of the National Lung Screening Trial, two large randomized cancer screening trials, enrolled almost 190,000 participants on whom annual contact was necessary. Ten screening centers participated in both trials. Centers developed methods to track participants and trace them when necessary. We describe the methods used to keep track of participants and trace them when lost, and the extent to which each method was used. Screening center coordinators were asked, using a self-administered paper questionnaire, to rate the extent to which specific tracking and tracing methods were used. Many methods were used by the screening centers, including telephone calls, mail, and internet searches. The most extensively used methods involved telephoning the participant on his or her home or cell phone, or telephoning a person identified by the participant as someone who would know about the participant's whereabouts. Internet searches were used extensively as well; these included searches on names, reverse-lookup searches (on addresses or telephone numbers) and searches of the Social Security Death Index. Over time, the percentage of participants requiring tracing decreased. Telephone communication and internet services were useful in keeping track of PLCO and LSS participants and tracing them when contact information was no longer valid. Published by Elsevier Inc.

  1. A randomised controlled trial of repeated filmed social contact on reducing mental illness-related stigma in young adults.

    Science.gov (United States)

    Koike, S; Yamaguchi, S; Ojio, Y; Ohta, K; Shimada, T; Watanabe, K; Thornicroft, G; Ando, S

    2018-04-01

    Public stigma alters attitudes towards people with mental illness, and is a particular concern for young people since most mental health problems occur in adolescence and young adulthood. However, little is known about the long-term effects of repeated filmed social contact (FSC) on reducing mental health-related stigma among young adults in the general population, compared with self-instructional Internet search (INS) and control interventions. This study is a parallel-group randomised controlled trial over 12 months conducted in Tokyo, Japan. A total of 259 university students (male n = 150, mean age = 20.0 years, s.d. = 1.2) were recruited from 20 colleges and universities between November 2013 and July 2014, without being provided information about the mental health-related survey or trial. Participants were assigned to one of three groups before completion of the baseline survey (FSC/INS/control = 89/83/87). The FSC group received a computer-based 30-min social contact film with general mental health education and five follow-up web-based FSCs at 2-month intervals. The INS group undertook a 30-min search for mental health-related information with five follow-up web-based reminders for self-instructional searches at 2-month intervals. The control group played PC games and had no follow-up intervention. The main outcome measures were the future (intended behaviour) domain of the Reported and Intended Behaviour Scale at 12 months after the intervention. Analysis was conducted in September 2015. At the 12-month follow-up, 218 participants completed the survey (84.1%, 75:70:73). The FSC group showed the greatest change at the 12-month follow-up (FSC: mean change 2.11 [95% CI 1.49, 2.73], INS: 1.04 [0.29, 1.80], control: 0.71 [0.09, 1.33]; FSC v. INS p = 0.037, FSC v. controls p = 0.004). No adverse events were reported during the follow-up period. FSC was more successful in reducing stigma at 12 months after intervention than INS or control interventions. FSC could

  2. Motivations and concerns about adolescent tuberculosis vaccine trial participation in rural Uganda: a qualitative study.

    Science.gov (United States)

    Buregyeya, Esther; Kulane, Asli; Kiguli, Juliet; Musoke, Phillipa; Mayanja, Harriet; Mitchell, Ellen Maeve Hanlon

    2015-01-01

    Research is being carried out to develop and test new potentially more effective tuberculosis vaccines. Among the vaccines being developed are those that target adolescents. This study explored the stakeholders' perceptions about adolescent participation in a hypothetical tuberculosis vaccine trial in Ugandan adolescents. Focus group discussions with adolescents, parents of infants and adolescents, and key informant interviews with community leaders and traditional healers were conducted. The majority of the respondents expressed potential willingness to allow their children participate in a tuberculosis vaccine trial. Main motivations for potential participation would be being able to learn about health-related issues. Hesitations included the notion that trial participation would distract the youths from their studies, fear of possible side effects of an investigational product, and potential for being sexually exploited by researchers. In addition, bad experiences from participation in previous research and doubts about the importance of research were mentioned. Suggested ways to motivate participation included: improved clarity on study purpose, risks, benefits and better scheduling of study procedures to minimize disruption to participants' academic schedules. Findings from this study suggest that the community is open to potential participation of adolescents in a tuberculosis vaccine trial. However, there is a need to communicate more effectively with the community about the purpose of the trial and its effects, including safety data, in a low-literacy, readily understood format. This raises a challenge to researchers, who cannot know all the potential effects of a trial product before it is tested.

  3. Mitochondrial disease patient motivations and barriers to participate in clinical trials.

    Directory of Open Access Journals (Sweden)

    Zarazuela Zolkipli-Cunningham

    Full Text Available Clinical treatment trials are increasingly being designed in primary mitochondrial disease (PMD, a phenotypically and genetically heterogeneous collection of inherited multi- system energy deficiency disorders that lack effective therapy. We sought to identify motivating factors and barriers to clinical trial participation in PMD.A survey study was conducted in two independent mitochondrial disease subject cohorts. A discovery cohort invited subjects with well-defined biochemical or molecularly- confirmed PMD followed at a single medical center (CHOP, n = 30/67 (45% respondents. A replication cohort included self-identified PMD subjects in the Rare Disease Clinical Research Network (RDCRN national contact registry (n = 290/1119 (26% respondents. Five-point Likert scale responses were analyzed using descriptive and quantitative statistics. Experienced and prioritized symptoms for trial participation, and patient attitudes toward detailed aspects of clinical trial drug features and study design.PMD subjects experienced an average of 16 symptoms. Muscle weakness, chronic fatigue, and exercise intolerance were the lead symptoms encouraging trial participation. Motivating trial design factors included a self-administered study drug; vitamin, antioxidant, natural or plant-derivative; pills; daily treatment; guaranteed treatment access during and after study; short travel distances; and late-stage (phase 3 participation. Relative trial participation barriers included a new study drug; discontinuation of current medications; disease progression; daily phlebotomy; and requiring participant payment. Treatment trial type or design preferences were not influenced by population age (pediatric versus adult, prior research trial experience, or disease severity.These data are the first to convey clear PMD subject preferences and priorities to enable improved clinical treatment trial design that cuts across the complex diversity of disease. Partnering with rare

  4. Mexican-American perspectives on participation in clinical trials: A qualitative study

    Directory of Open Access Journals (Sweden)

    Mariana Arevalo

    2016-12-01

    Full Text Available Clinical trials are essential to advancing knowledge to reduce disease morbidity and mortality; however, ethnic and racial minorities remain under-represented in those studies. We explored knowledge and perceptions of clinical trials among Mexican-Americans in Texas. We conducted focus groups (N = 128 stratified by gender, language preference, and geographical location. This paper presents four emergent, primary themes: 1 knowledge and understanding of clinical trials, 2 fears and concerns about participating, 3 perceived benefits of participating, and 4 incentives to participate. Results suggest that lack of knowledge and understanding of clinical trials leads to misunderstanding about research, including fears and lack of trust. Participants indicated that fears related to perceived experimentation, harm, immigration status, and lack of clinical trial opportunities within their communities were barriers to participation. On the other hand, free healthcare access, helping family members in the future, and monetary incentives could facilitate participation. We also found differences across themes by language, gender, and place of residence. Findings from our study could inform the development of interventions to enhance recruitment of Mexican-American participants into clinical trials.

  5. Participants' Understanding of Informed Consent in a Randomized Controlled Trial for Chronic Knee Pain.

    Science.gov (United States)

    Guillemin, Marilys; Barnard, Emma; Walker, Hannah; Bennell, Kim; Hinman, Rana; Gillam, Lynn

    2015-12-01

    This study explored participants' experiences of randomized controlled trial (RCT) participation to examine their understanding of the trial design and whether their consent was indeed informed. A nested qualitative interview study was conducted with 38 participants from a sample of 282 who participated in a complex RCT evaluating the effectiveness of laser compared with needle acupuncture for chronic knee pain. Overall participants had a good understanding of the RCT, and concepts such as randomization and placebo. Their experiences of being in the trial were largely positive, even if they did not experience any knee pain improvement. Their responses to unblinding at the end of the study were accepting. Participants had a good functional understanding of the RCT, sufficient for valid informed consent. © The Author(s) 2015.

  6. LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ

    NARCIS (Netherlands)

    Rutten, G.E.; Tack, C.J.J.; Pieber, T.R.; Comlekci, A.; Orsted, D.D.; Baeres, F.M.; Marso, S.P.; Buse, J.B.

    2016-01-01

    AIMS: To determine whether US and European participants in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial differ regarding risk factors for cardiovascular mortality and morbidity. METHODS: Baseline data, stratified for prior cardiovascular

  7. LEADER 7 : Cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ

    NARCIS (Netherlands)

    Rutten, Guy E H M; Tack, Cees J.; Pieber, Thomas R.; Comlekci, Abdurrahman; Ørsted, David Dynnes; Baeres, Florian M M; Marso, Steven P.; Buse, John B.

    2016-01-01

    Aims: To determine whether US and European participants in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial differ regarding risk factors for cardiovascular mortality and morbidity. Methods: Baseline data, stratified for prior cardiovascular

  8. Young People's Experiences of Participation in Clinical Trials : Reasons for Taking Part

    NARCIS (Netherlands)

    Luchtenberg, Malou; Maeckelberghe, Els; Locock, Louise; Powell, Lesley; Verhagen, A. A. Eduard

    2015-01-01

    Given the lack of knowledge about safety and efficacy of many treatments for children, pediatric clinical trials are important, but recruitment for pediatric research is difficult. Little is known about children's perspective on participating in trials. The purpose of this study was to understand

  9. Differences between participants and nonparticipants in an exercise trial for adults with rheumatoid arthritis.

    NARCIS (Netherlands)

    Jong, Z. de; Munneke, M.; Jansen, L.M.; Ronday, K.; Schaardenburg, D.J. van; Brand, R.; Ende, C.H.M. van den; Vliet Vlieland, T.P.M.; Zuijderduin, W.M.; Hazes, J.M.

    2004-01-01

    OBJECTIVE: To investigate the generalizability of the results of a randomized controlled trial on the effectiveness of long-term, high-intensity exercises in the rheumatoid arthritis patients in training (RAPIT) trial by comparing the characteristics of the participants with the nonparticipants.

  10. Exit interviews administered to patients participating in the COSTOP placebo controlled randomised trial in Uganda

    Directory of Open Access Journals (Sweden)

    Andrew Nunn

    2016-08-01

    Discussion: The exit interview demonstrated that there was some evidence of open label drug being taken by the participants. However, the results from the interview do not suggest that the trial results would have been seriously compromised. We would recommend the exit interview as a valuable way of assessing adherence to trial procedures.

  11. Reasons for participation and non-participation in a diabetes prevention trial among women with prior gestational diabetes mellitus (GDM).

    Science.gov (United States)

    Infanti, Jennifer J; O'Dea, Angela; Gibson, Irene; McGuire, Brian E; Newell, John; Glynn, Liam G; O'Neill, Ciaran; Connolly, Susan B; Dunne, Fidelma P

    2014-01-24

    Gestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Lifestyle intervention can prevent progression to type 2 diabetes in high risk populations. We designed a randomised controlled trial (RCT) to evaluate the effectiveness of an established lifestyle intervention compared to standard care for delaying diabetes onset in European women with recent GDM. Recruitment into the RCT was more challenging than anticipated with only 89 of 410 (22%) women agreeing to participate. This paper identifies factors that could enhance participation of the target population in future interventions. We hypothesised that women who agreed to participate would have higher diabetes risk profiles than those who declined, and secondly that it would be possible to predict participation on the bases of those risk factors. To test our hypothesis, we identified the subset of women for whom we had comprehensive data on diabetes risks factors 3-5 years following GDM, reducing the sample to 43 participants and 73 decliners. We considered established diabetes risk factors: smoking, daily fruit and vegetable intake, participation in exercise, family history of diabetes, glucose values and BMI scores on post-partum re-screens, use of insulin during pregnancy, and age at delivery. We also analysed narrative data from 156 decliners to further understand barriers to and facilitators of participation. Two factors differentiated participants and decliners: age at delivery (with women older than 34 years being more likely to participate) and insulin use during pregnancy (with women requiring the use of insulin in pregnancy less likely to participate). Binary logistic regression confirmed that insulin use negatively affected the odds of participation. The most significant barriers to participation included the accessibility, affordability and practicality of the intervention. Women with recent GDM face multiple barriers to lifestyle change. Intervention designers

  12. Methodical principles of assessment of financial compensation for clinical trial volunteer participants

    Directory of Open Access Journals (Sweden)

    V. Ye. Dobrova

    2013-10-01

    Full Text Available Introduction. Due to the necessity to obtain the reliable results of a clinical trial and to distribute it to the general population of patients the problem of recruiting the adequate number of individuals to participate in the study as objects of observation in the group receiving the investigational medicinal product or as a member of the control group should to be solved. Aim of study. The aim of our study was to research and to justify practically the methodological approaches to determining financial compensation for participation of volunteers in the clinical trials and the appropriate methods of its calculation. Material and methods. For the purpose of determining the baseline factors for calculating the hourly compensation the survey of healthy volunteers and of expert professionals as well as the analysis of its results have been done. Questioning healthy volunteers regarding their attitudes towards inconvenience and discomfort during participation in clinical trials was held at the Ukrainian clinical research centers. Survey participants number was 99, they were healthy volunteers who took part in the first phase clinical trial or bioequivalence studies. The expert survey included questioning of the 193 professionals from Ukrainian clinical research centers, CRO, pharmaceutical manufacturers – research sponsors and collaborators State Expert Center Ministry of Health of Ukraine, who were involved in the planning, organization, implementation and evaluation of clinical trials as well as their regulatory control. Results of study. Using the method of pairwise comparisons and iterative refinement procedures the collective estimate of experts questionnaire results has been performed, by the results of which the nine indicators have been identified and the importance of each of them as units of discomfort have been established. Motivational factors of voluntary participation in clinical trials have been studied. Motivation system for

  13. Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process.

    Science.gov (United States)

    Mexas, Fernanda; Efron, Anne; Luiz, Ronir Raggio; Cailleaux-Cezar, Michelle; Chaisson, Richard E; Conde, Marcus B

    2014-02-01

    for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking. To assess the understanding and retention of trial-related information presented in the IC process by administering an informed consent assessment instrument (ICAI) to participants in a clinical trial for a new tuberculosis (TB) regimen being conducted in Rio de Janeiro (Brazil). Methods The format of the ICAI was based on the language and structure of the United States National Cancer Institute's IC comprehension checklist. The ICAI was designed to assess points of the RioMAR study IC process that addressed the principles of research ethics requested by Brazilian Regulatory Authority: autonomy, beneficence, non-maleficence, and justice. Briefly, (1) Is the respondent participating in a clinical trial? (2) Are two different treatments being evaluated? (3) Is the treatment arm chosen by chance? (4) Is an HIV test required? (5) Are liver function tests required? (6) Can participants leave the study at any time? (7) Are the risks and benefits of taking part in the study clear? (8) May pregnant women participate in the study? (9) Can one of the study drugs reduce the effectiveness of contraceptives? (10) Are patients paid to participate in the study? The ICAI was applied at two time points: immediately after enrollment in the clinical trial and 2 months later. A total of 61 patients who enrolled in the RioMAR study participated in this study. The percentage of correct answers to all questions was 82% at the time of the first ICAI; 31 participants (51%) did not recall that an HIV test was required (question 4) and 43 (70%) did not know that they could leave the study (question 6). Other individual questions were answered correctly by at least 76% of participants. There was no association between incorrect answers and age, gender, monthly family income, neighborhood, or level of education (p > 0.07). When the responses to the

  14. Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial.

    Science.gov (United States)

    Lawrie, Theresa A; Betrán, Ana Pilar; Singata-Madliki, Mandisa; Ciganda, Alvaro; Hofmeyr, G Justus; Belizán, José M; Purnat, Tina Dannemann; Manyame, Sarah; Parker, Catherine; Cormick, Gabriela

    2017-10-26

    The preconception period has the potential to influence pregnancy outcomes and randomized controlled trials (RCTs) are needed to evaluate a variety of potentially beneficial preconception interventions. However, RCTs commencing before pregnancy have significant participant recruitment and retention challenges. The Calcium And Pre-eclampsia trial (CAP trial) is a World Health Organization multi-country RCT of calcium supplementation commenced before pregnancy to prevent recurrent pre-eclampsia in which non-pregnant participants are recruited and followed up until childbirth. This sub-study explores recruitment methods and preconception retention of participants of the CAP trial to inform future trials. Recruiters at the study sites in Argentina, South Africa and Zimbabwe completed post-recruitment phase questionnaires on recruitment methods used. Qualitative data from these questionnaires and quantitative data on pre-pregnancy trial visit attendance and pregnancy rates up to September 2016 are reported in this paper. RStudio (Version 0.99.903 https://www.rstudio.org ) statistical software was used for summary statistics. Between July 2011 and 8 September 2016, 1354 women with previous pre-eclampsia were recruited. Recruitment took 2 years longer than expected and was facilitated mainly through medical record/register and maternity ward/clinic-based strategies. Recruiters highlighted difficulties associated with inadequate medical records, redundant patient contact details, and follow-up of temporarily ineligible women as some of the challenges faced. Whilst the attendance rates at pre-pregnancy visits were high (78% or more), visits often occurred later than scheduled. Forty-five percent of participants became pregnant (614/1354), 33.5% (454/1354) within 1 year of randomization. In preconception trials, both retrospective and prospective methods are useful for recruiting eligible women with certain conditions. However, these are time-consuming in low

  15. Participants' perceptions and understanding of a malaria clinical trial in Bangladesh.

    Science.gov (United States)

    Das, Debashish; Cheah, Phaik Yeong; Akter, Fateha; Paul, Dulal; Islam, Akhterul; Sayeed, Abdullah A; Samad, Rasheda; Rahman, Ridwanur; Hossain, Amir; Dondorp, Arjen; Day, Nicholas P; White, Nicholas J; Hasan, Mahtabuddin; Ghose, Aniruddha; Ashley, Elizabeth A; Faiz, Abul

    2014-06-04

    Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. Of 16 participants, the vast majority (81%) were illiterate. All subjects had a 'therapeutic misconception' i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients' perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants' satisfaction with treatment and nursing care. There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings.

  16. The Utility of Repeat Culture in Fungal Corneal Ulcer Management: A Secondary Analysis of the MUTT-I Randomized Clinical Trial.

    Science.gov (United States)

    Ray, Kathryn J; Lalitha, Prajna; Prajna, N Venkatesh; Rajaraman, Revathi; Krishnan, Tiruvengada; Srinivasan, Muthiah; Ryg, Peter; McLeod, Stephen; Acharya, Nisha R; Lietman, Thomas M; Rose-Nussbaumer, Jennifer

    2017-06-01

    To determine whether patients who had a positive repeated culture was predictive of worse clinical outcome than those who achieved microbiological cure at 6 days in the Mycotic Ulcer Treatment Trial I (MUTT-I). Secondary analysis from a multicenter, double-masked, randomized clinical trial. setting: Multiple hospital sites of the Aravind Eye Care System, India. Patients with culture-positive filamentous fungal ulcers and visual acuity of 20/40 to 20/400 reexamined 6 days after initiation of treatment. Corneal scraping and cultures were obtained from study participants at day 6 after enrollment. We assessed 3-month best spectacle-corrected visual acuity (BSCVA), 3-month infiltrate/scar size, corneal perforation, and re-epithelialization rates stratified by culture positivity at day 6. Of the 323 patients with smear-positive ulcers enrolled in MUTT-I, 299 (92.6%) were scraped and cultured 6 days after enrollment. Repeat culture positivity was 31% (92/299). Among patients who tested positive at enrollment, those with positive 6-day cultures had significantly worse 3-month BSCVA (0.39 logMAR; 95% confidence interval [CI]: 0.24-0.44; P cure on culture is a predictor of clinical response to treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis.

    Science.gov (United States)

    Carter, Anouska; Humphreys, Liam; Snowdon, Nicky; Sharrack, Basil; Daley, Amanda; Petty, Jane; Woodroofe, Nicola; Saxton, John

    2015-10-15

    The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Despite an increase in research into the benefits of exercise in people with multiple sclerosis (PwMS), no trial has reported detailed data on effective recruitment strategies for large-scale randomised controlled trials. The main purpose of this report is to provide a detailed outline of recruitment strategies, rates and estimated costs in the Exercise Intervention for Multiple Sclerosis (ExIMS) trial to identify best practices for future trials involving multiple sclerosis (MS) patient recruitment. The ExIMS researchers recruited 120 PwMS to participate in a 12-week exercise intervention. Participants were randomly allocated to either exercise or usual-care control groups. Participants were sedentary, aged 18-65 years and had Expanded Disability Status Scale scores of 1.0-6.5. Recruitment strategies included attendance at MS outpatient clinics, consultant mail-out and trial awareness-raising activities. A total of 120 participants were recruited over the course of 34 months. To achieve this target, 369 potentially eligible and interested participants were identified. A total of 60 % of participants were recruited via MS clinics, 29.2 % from consultant mail-outs and 10.8 % through trial awareness. The randomisation yields were 33.2 %, 31.0 % and 68.4 % for MS clinic, consultant mail-outs and trial awareness strategies, respectively. The main reason for ineligibility was being too active (69.2 %), whilst for eligible participants the most common reason for non-participation was the need to travel to the study site (15.8 %). Recruitment via consultant mail-out was the most cost-effective strategy, with MS clinics being the most time-consuming and most costly. To reach recruitment targets in a timely fashion, a variety of methods were employed. Although consultant mail-outs were the most cost-effective recruitment strategy, use of this

  18. A Review of Barriers to Minorities' Participation in Cancer Clinical Trials: Implications for Future Cancer Research.

    Science.gov (United States)

    Salman, Ali; Nguyen, Claire; Lee, Yi-Hui; Cooksey-James, Tawna

    2016-04-01

    To enhance nurses' awareness and competencies in practice and research by reporting the common barriers to participation of minorities in cancer clinical trials and discussing facilitators and useful strategies for recruitment. Several databases were searched for articles published in peer reviewed journals. Some of the barriers to minorities' participation in clinical trials were identified within the cultural social-context of cancer patients. The involvement of community networking was suggested as the most effective strategy for the recruitment of minorities in cancer clinical trials. Using culturally sensitive approaches to enhance ethnic minorities' participation is important for advancing cancer care and eliminating health disparities. Awareness of barriers and potential facilitators to the enrollment of ethnic minority cancer patients may contribute to enhancing nurses' competencies of recruiting ethnic minorities in nursing research, playing efficient roles in cancer clinical trials team, and providing culturally competent quality care.

  19. Motivators to participation in medical trials: the application of social and personal categorization.

    Science.gov (United States)

    Dhalla, Shayesta; Poole, Gary

    2013-01-01

    The Health Belief Model provides a framework to understand motivators for volunteering for medical research. Motivators can take the form of social and personal benefits. In this systematic review of review articles, we contrast motivators of participation in actual cancer trials to those in actual HIV vaccine trials. We retrieved eight review articles from 2000 to 2012 examining motivators to participation in actual cancer trials. Personal benefits were most often psychological in nature, such as "coping with symptoms." Social benefits included "advancing research," "helping other cancer patients," and "for their family." While specific motivators vary between considerations - cancer research and HIV vaccine trials, these motivators fall into similar categories at similar frequencies. For example, personal/psychological benefits are common in each. Participant recruitment must be mindful of these categories of motivators for both cancer and HIV vaccine research.

  20. Factors and outcomes of decision making for cancer clinical trial participation.

    Science.gov (United States)

    Biedrzycki, Barbara A

    2011-09-01

    To describe factors and outcomes related to the decision-making process regarding participation in a cancer clinical trial. Cross-sectional, descriptive. Urban, academic, National Cancer Institute-designated comprehensive cancer center in the mid-Atlantic United States. 197 patients with advanced gastrointestinal cancer. Mailed survey using one investigator-developed instrument, eight instruments used in published research, and a medical record review. disease context, sociodemographics, hope, quality of life, trust in healthcare system, trust in health professional, preference for research decision control, understanding risks, and information. decision to accept or decline research participation and satisfaction with this decision. All of the factors within the Research Decision Making Model together predicted cancer clinical trial participation and satisfaction with this decision. The most frequently preferred decision-making style for research participation was shared (collaborative) (83%). Multiple factors affect decision making for cancer clinical trial participation and satisfaction with this decision. Shared decision making previously was an unrecognized factor and requires further investigation. Enhancing the process of research decision making may facilitate an increase in cancer clinical trial enrollment rates. Oncology nurses have unique opportunities as educators and researchers to support shared decision making by those who prefer this method for deciding whether to accept or decline cancer clinical trial participation.

  1. External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?

    Science.gov (United States)

    Saunders, C; Byrne, C D; Guthrie, B; Lindsay, R S; McKnight, J A; Philip, S; Sattar, N; Walker, J J; Wild, S H

    2013-03-01

    To describe the proportion of people with Type 2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results. A literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Inclusion and exclusion criteria from each trial were applied to data on the population of people with a diagnosis of Type 2 diabetes living in Scotland in 2008 (n = 180,590) in a population-based cross-sectional study and the number and proportion of people eligible for each trial was determined. Seven trials were identified. The proportion of people with Type 2 diabetes who met the eligibility criteria for the trials ranged from 3.5 to 50.7%. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population. The application of upper age criteria excluded the largest proportion of patients, with up to 39% of people with Type 2 diabetes ineligible for a trial with the most stringent criteria based on age alone. We found that many of the large trials of glycaemic control among people with Type 2 diabetes have limited external validity when applied to a population-based cohort of people with Type 2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type 2 diabetes in a contemporary British population. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

  2. Recruitment of Participants to a Clinical Trial of Botanical Therapy for Benign Prostatic Hyperplasia

    Science.gov (United States)

    Foster, Harris E.; McVary, Kevin T.; Meleth, Sreelatha; Stavris, Karen; Downey, Joe; Kusek, John W.

    2011-01-01

    Abstract Objectives The timely recruitment of study participants is a critical component of successful trials. Benign prostatic hyperplasia (BPH), a common nonmalignant urologic condition among older men, is characterized by lower urinary tract symptoms (LUTS). Successful recruitment methods for a trial of medical therapy for BPH, Medical Therapy of Prostate Symptoms (MTOPS), were mass mailing and advertising. The Complementary and Alternative Medicines Trial for Urological Symptoms (CAMUS) was designed to evaluate a botanical therapy, saw palmetto, for the treatment of BPH. The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy. Design CAMUS is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS. Subjects The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period. The recruitment techniques used and participants contacted, screened, and randomized through each technique were obtained from the clinical centers. Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS. Results The target enrollment goal was achieved in 11 months. The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0. The most successful recruitment methods were mass mailing and advertising, which accounted for 39% and 35% of the study participants, respectively. In comparison to MTOPS participants, CAMUS participants were younger, more highly educated, more diverse, and had less severe urinary symptoms. Conclusions Successful recruitment methods for CAMUS were similar to those in MTOPS. The use of botanical therapy attracted a less symptomatic and more educated

  3. Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia.

    Science.gov (United States)

    Lee, Jeannette Y; Foster, Harris E; McVary, Kevin T; Meleth, Sreelatha; Stavris, Karen; Downey, Joe; Kusek, John W

    2011-05-01

    The timely recruitment of study participants is a critical component of successful trials. Benign prostatic hyperplasia (BPH), a common nonmalignant urologic condition among older men, is characterized by lower urinary tract symptoms (LUTS). Successful recruitment methods for a trial of medical therapy for BPH, Medical Therapy of Prostate Symptoms (MTOPS), were mass mailing and advertising. The Complementary and Alternative Medicines Trial for Urological Symptoms (CAMUS) was designed to evaluate a botanical therapy, saw palmetto, for the treatment of BPH. The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy. CAMUS is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS. The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period. The recruitment techniques used and participants contacted, screened, and randomized through each technique were obtained from the clinical centers. Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS. The target enrollment goal was achieved in 11 months. The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0. The most successful recruitment methods were mass mailing and advertising, which accounted for 39% and 35% of the study participants, respectively. In comparison to MTOPS participants, CAMUS participants were younger, more highly educated, more diverse, and had less severe urinary symptoms. Successful recruitment methods for CAMUS were similar to those in MTOPS. The use of botanical therapy attracted a less symptomatic and more educated study population.

  4. Enhancing decision making about participation in cancer clinical trials: development of a question prompt list

    Science.gov (United States)

    Brown, Richard F.; Shuk, Elyse; Leighl, Natasha; Butow, Phyllis; Ostroff, Jamie; Edgerson, Shawna; Tattersall, Martin

    2016-01-01

    Purpose Slow accrual to cancer clinical trials impedes the progress of effective new cancer treatments. Poor physician–patient communication has been identified as a key contributor to low trial accrual. Question prompt lists (QPLs) have demonstrated a significant promise in facilitating communication in general, surgical, and palliative oncology settings. These simple patient interventions have not been tested in the oncology clinical trial setting. We aimed to develop a targeted QPL for clinical trials (QPL-CT). Method Lung, breast, and prostate cancer patients who either had (trial experienced) or had not (trial naive) participated in a clinical trial were invited to join focus groups to help develop and explore the acceptability of a QPL-CT. Focus groups were audio-recorded and transcribed. A research team, including a qualitative data expert, analyzed these data to explore patients’ decision-making processes and views about the utility of the QPL-CT prompt to aid in trial decision making. Results Decision making was influenced by the outcome of patients’ comparative assessment of perceived risks versus benefits of a trial, and the level of trust patients had in their doctors’ recommendation about the trial. Severity of a patient’s disease influenced trial decision making only for trial-naive patients. Conclusion Although patients were likely to prefer a paternalistic decision-making style, they expressed valuation of the QPL as an aid to decision making. QPL-CT utility extended beyond the actual consultation to include roles both before and after the clinical trial discussion. PMID:20593202

  5. Participant recruitment to FiCTION, a primary dental care trial - survey of facilitators and barriers.

    Science.gov (United States)

    Keightley, A; Clarkson, J; Maguire, A; Speed, C; Innes, N

    2014-11-01

    To identify reasons behind a lower than expected participant recruitment rate within the FiCTION trial, a multi-centre paediatric primary dental care randomised controlled trial (RCT). An online survey, based on a previously published tool, consisting of both quantitative and qualitative responses, completed by staff in dental practices recruiting to FiCTION. Ratings from quantitative responses were aggregated to give overall scores for factors related to participant recruitment. Qualitative responses were independently grouped into themes. Thirty-nine anonymous responses were received. Main facilitators related to the support received from the central research team and importance of the research question. The main barriers related to low child eligibility rates and the integration of trial processes within routine workloads. These findings have directed strategies for enhancing participant recruitment at existing practices and informed recruitment of further practices. The results help provide a profile of the features required of practices to successfully screen and recruit participants. Future trials in this setting should consider the level of interest in the research question within practices, and ensure trial processes are as streamlined as possible. Research teams should actively support practices with participant recruitment and maintain enthusiasm among the entire practice team.

  6. At what price? A cost-effectiveness analysis comparing trial of labour after previous Caesarean versus elective repeat Caesarean delivery.

    LENUS (Irish Health Repository)

    Fawsitt, Christopher G

    2013-01-01

    Elective repeat caesarean delivery (ERCD) rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland.

  7. Characteristics of clinical trials that require participants to be fluent in English.

    Science.gov (United States)

    Egleston, Brian L; Pedraza, Omar; Wong, Yu-Ning; Dunbrack, Roland L; Griffin, Candace L; Ross, Eric A; Beck, J Robert

    2015-12-01

    Diverse samples in clinical trials can make findings more generalizable. We sought to characterize the prevalence of clinical trials in the United States that required English fluency for participants to enroll in the trial. We randomly chose over 10,000 clinical trial protocols registered with ClinicalTrials.gov and examined the inclusion and exclusion criteria of the trials. We compared the relationship of clinical trial characteristics with English fluency inclusion requirements. We merged the ClinicalTrials.gov data with US Census and American Community Survey data to investigate the association of English-language restrictions with ZIP-code-level demographic characteristics of participating institutions. We used Chi-squared tests, t-tests, and logistic regression models for analyses. English fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010 (p English fluency requirements (1.8%), while behavioral trials had high rates (28.4%). Trials opening in the Northeast of the United States had the highest regional English requirement rates (10.7%), while trials opening in more than one region had the lowest (3.3%, pEnglish fluency requirements (odds ratio=0.92 for each 10% increase in proportion of Hispanics, 95% confidence interval=0.86-0.98, p=0.013). Trials opening in ZIP codes with more residents self-identifying as Black/African American (odds ratio=1.87, 95% confidence interval=1.36-2.58, pEnglish fluency requirements. ZIP codes with higher poverty rates had trials with more English-language restrictions (odds ratio=1.06 for a 10% poverty rate increase, 95% confidence interval=1.001-1.11, p=0.045). There was a statistically significant interaction between year and intervention type, such that the increase in English fluency requirements was more common for some interventions than for others. The proportion of clinical trials registered with ClinicalTrials.gov that have English fluency

  8. African Americans and participation in clinical trials: differences in beliefs and attitudes by gender.

    Science.gov (United States)

    BeLue, R; Taylor-Richardson, K D; Lin, J; Rivera, A T; Grandison, D

    2006-12-01

    To explore gender differences in perceptions of 1) barriers and motivators to participation in clinical trials and perceived need of clinical trials and 2) perceptions of risks and benefits of participation in clinical trials in African American men and women. Focus groups were conducted among African American participants by gender. A total of 67 African American participated in the focus groups. All focus groups were audio-taped and transcribed verbatim. Data analysis was performed by combining the key elements of grounded theory and content analysis with the assistance of the qualitative software ATLAS.ti 5.0. Different themes emerged for men versus women. The business and economic of research were important to male participants. The researcher-participant relationship emerged as one of the strongest themes related to potential female participation in research. Focus group results indicate that African American men and women present different preferences, beliefs and barriers to participation. Men expressed the desire to know information on funding issues, financial benefit and impact of the research. Women expressed the desire to be treated respectfully and as an individual as opposed to just a study subject. Integrating gender preferences into researcher-participant interactions, advertisement, informed consent delivery and advertisement of research studies may lead to increased participation rates. Discussing and presenting relevant information on clinical research funding mechanisms, and the business of clinical research with potential participants may be helpful in building trust with the researcher and the research team. Creating a process for information exchange and methods to minimize the power imbalance between the researcher and participant may also build trust and help participants feel more comfortable to participate in research.

  9. Co-enrolment of Participants into Multiple Cancer Trials: Benefits and Challenges.

    Science.gov (United States)

    Cafferty, F H; Coyle, C; Rowley, S; Berkman, L; MacKensie, M; Langley, R E

    2017-07-01

    Opportunities to enter patients into more than one clinical trial are not routinely considered in cancer research and experiences with co-enrolment are rarely reported. Potential benefits of allowing appropriate co-enrolment have been identified in other settings but there is a lack of evidence base or guidance to inform these decisions in oncology. Here, we discuss the benefits and challenges associated with co-enrolment based on experiences in the Add-Aspirin trial - a large, multicentre trial recruiting across a number of tumour types, where opportunities to co-enrol patients have been proactively explored and managed. The potential benefits of co-enrolment include: improving recruitment feasibility; increased opportunities for patients to participate in trials; and collection of robust data on combinations of interventions, which will ensure the ongoing relevance of individual trials and provide more cohesive evidence to guide the management of future patients. There are a number of perceived barriers to co-enrolment in terms of scientific, safety and ethical issues, which warrant consideration on a trial-by-trial basis. In many cases, any potential effect on the results of the trials will be negligible - limited by a number of factors, including the overlap in trial cohorts. Participant representatives stress the importance of autonomy to decide about trial enrolment, providing a compelling argument for offering co-enrolment where there are multiple trials that are relevant to a patient and no concerns regarding safety or the integrity of the trials. A number of measures are proposed for managing and monitoring co-enrolment. Ensuring acceptability to (potential) participants is paramount. Opportunities to enter patients into more than one cancer trial should be considered more routinely. Where planned and managed appropriately, co-enrolment can offer a number of benefits in terms of both scientific value and efficiency of study conduct, and will increase the

  10. Chlamydia screening is not cost-effective at low participation rates: evidence from a repeated register-based implementation study in The Netherlands

    NARCIS (Netherlands)

    de Wit, G. Ardine; Over, Eelco A. B.; Schmid, Boris V.; van Bergen, Jan E. A. M.; van den Broek, Ingrid V. F.; van der Sande, Marianne A. B.; Welte, Robert; Op de Coul, Eline L. M.; Kretzschmar, Mirjam E.

    2015-01-01

    In three pilot regions of The Netherlands, all 16-29 year olds were invited to participate in three annual rounds of Chlamydia screening. The aim of the present study is to evaluate the cost-effectiveness of repeated Chlamydia screening, based on empirical data. A mathematical model was employed to

  11. Challenges with participant reimbursement: experiences from a post-trial access study.

    Science.gov (United States)

    Mngadi, Kathryn Therese; Frohlich, Janet; Montague, Carl; Singh, Jerome; Nkomonde, Nelisiwe; Mvandaba, Nomzamo; Ntombeka, Fanelesibonge; Luthuli, Londiwe; Abdool Karim, Quarraisha; Mansoor, Leila

    2015-11-01

    Reimbursement of trial participants remains a frequently debated issue, with specific guidance lacking. Trials combining post-trial access and implementation science may necessitate new strategies and models. CAPRISA 008, a post-trial access study testing the feasibility of using family planning services to rollout a prelicensure HIV prevention intervention, tried to balance the real-life scenario of no reimbursement for attendance at public sector clinics with that of a trial including some visits that focused on research procedures and others that focused on standard of care procedures. A reduced reimbursement was offered for 'standard of care' visits, meant primarily to cover transport costs to and from the clinic only. This impacted negatively on accrual, retention and participant morale, primarily due to the protracted delay in regulatory approval, during which time, the costs of living, including travel costs had increased. Relevant guidelines were reviewed and institutional policy was updated to incorporate the South African National Health Research Ethics Committee guidelines on reimbursement (taking into account participant time, travel and inconvenience). The reimbursement amount for 'standard of care' visits was increased accordingly. The question remains whether a trial that combines post-trial access with implementation science, with clear benefits for the participants and the provision of above standard medical care, should have reimbursement rates that approach those of a proof-of-concept trial, for 'standard of care' visits. 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/

  12. South Asian participation in clinical trials: the views of lay people and health professionals.

    Science.gov (United States)

    Hussain-Gambles, Mah; Atkin, Karl; Leese, Brenda

    2006-07-01

    There is little UK-based empirical research on South Asian participation in clinical trials. The predominantly US literature rarely engages with mainstream debates about ethnicity, diversity and difference. This study was prompted by a lack of knowledge about how South Asian people perceive trial involvement and the risks and benefits involved. Face to face interviews were conducted with 25 health professionals (consultants, GPs, nursing staff, academics, non-medically trained trial co-ordinators, LREC and MREC members) and 60 South Asian lay people (20 Indians, 20 Pakistanis and 20 Bangladeshis) who had not taken part in a trial. The study took place in the Leeds and Bradford areas of England. It was found that lay South Asian attitudes towards clinical trial participation focused on similarities rather than differences with the general UK population, suggesting that the relevance of ethnicity should be kept in perspective. There was no evidence of antipathy amongst South Asians to the concept of clinical trials, and awareness was a correlate of social class, education and younger age. Lay factors that might affect South Asian participation in clinical trials included: age; language, social class; feeling of not belonging/mistrust; culture and religion. Approachable patients (of the same gender, social class and fluent in English) tended to be 'cherry picked' to clinical trials. This practice was justified because of a lack of time, resources and inadequate support. South Asian patients might be systematically excluded from trials due to the increased cost and time associated with their inclusion, particularly in relation to the language barrier. Under-representation might also be due to passive exclusion associated with cultural stereotypes. The paper concludes by applying the theoretical framework of institutional racism as a means of making sense of policy and practice. At the same time, caution is advocated against using ethnicity as the only form of

  13. Participants as community-based peer educators: Impact on a clinical trial site in KwaZulu-Natal

    Directory of Open Access Journals (Sweden)

    Sarita Naidoo

    2013-07-01

    Full Text Available Participant recruitment, retention and product adherence are necessary to measure the efficacy or effectiveness of an intervention in a clinical trial. As part of a Phase III HIV prevention trial in a rural area in Kwazulu-Natal, South Africa, a peer educator programme was initiated to aid in recruitment and retention of trial participants from the community. Enrolled trial participants who had completed at least 6 months of trial participation and who had honoured all of their scheduled trial visits within that period were approached to be peer educators. Following additional selection criteria, 24 participants were eligible to be trained as peer educators. Training topics included HIV/AIDS, sexually transmitted infections, nutrition, antiretrovirals, clinical trials, and methods of disseminating this information to the community. The role of peer educators was to bring interested women from their community to the trial site for comprehensive education and information about the trial and possibly trial participation. A total of 1879 women were educated by peer educators between July 2004 and December 2006. Of these, 553 women visited the trial site for further education and screening for participation in the trial. Peer educators provided continuous education and support to women enrolled in the trial which also promoted retention, ultimately contributing to the site's 94% retention rate. Recruitment and retention efforts of trial participants are likely to be enhanced by involving trial participants as peer educators. Such trial participants are in a better position to understand cultural dynamics and hence capable of engaging the community with appropriate HIV prevention and trial-related messaging.

  14. Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya.

    Science.gov (United States)

    Nyaoke, Borna A; Mutua, Gaudensia N; Sajabi, Rose; Nyasani, Delvin; Mureithi, Marianne W; Anzala, Omu A

    2017-01-01

    1.5 million Kenyans are living with HIV/AIDS as per 2015 estimates. Though there is a notable decline in new HIV infections, continued effort is still needed to develop an efficacious, accessible and affordable HIV vaccine. HIV vaccine clinical trials bear risks, hence a need to understand volunteer motivators for enrolment, retention and follow-up. Understanding the factors that motivate volunteers to participate in a clinical trial can help to strategize, refine targeting and thus increase enrolment of volunteers in future HIV vaccine clinical trials. The health belief model classifies motivators into social benefits such as 'advancing research' and collaboration with science, and personal benefits such as health benefits and financial interests. A thematic analysis was carried out on data obtained from four HIV clinical trials conducted at KAVI-Institute of Clinical Research in Nairobi Kenya from 2009 to 2015. Responses were obtained from a Questionnaire administered to the volunteers during their screening visit at the research site. Of the 281 healthy, HIV-uninfected volunteers participating in this study; 38% were motivated by personal benefits including, 31% motivated by health benefits and 7% motivated by possible financial gains. In addition, 62% of the volunteers were motivated by social benefits with 20% of who were seeking to help their family/society/world while 42% were interested in advancing research. The majority of volunteers in the HIV vaccine trials at our site were motivated by social benefits, suggesting that altruism can be a major contributor to participation in HIV vaccine studies. Personal benefits were a secondary motivator for the volunteers. The motivators to volunteer in HIV clinical trials were similar across ages, education level and gender. Education on what is needed (including volunteer participation) to develop an efficacious vaccine could be the key to greater volunteer motivation to participate in HIV vaccine clinical trials.

  15. Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya.

    Directory of Open Access Journals (Sweden)

    Borna A Nyaoke

    Full Text Available 1.5 million Kenyans are living with HIV/AIDS as per 2015 estimates. Though there is a notable decline in new HIV infections, continued effort is still needed to develop an efficacious, accessible and affordable HIV vaccine. HIV vaccine clinical trials bear risks, hence a need to understand volunteer motivators for enrolment, retention and follow-up. Understanding the factors that motivate volunteers to participate in a clinical trial can help to strategize, refine targeting and thus increase enrolment of volunteers in future HIV vaccine clinical trials. The health belief model classifies motivators into social benefits such as 'advancing research' and collaboration with science, and personal benefits such as health benefits and financial interests.A thematic analysis was carried out on data obtained from four HIV clinical trials conducted at KAVI-Institute of Clinical Research in Nairobi Kenya from 2009 to 2015. Responses were obtained from a Questionnaire administered to the volunteers during their screening visit at the research site.Of the 281 healthy, HIV-uninfected volunteers participating in this study; 38% were motivated by personal benefits including, 31% motivated by health benefits and 7% motivated by possible financial gains. In addition, 62% of the volunteers were motivated by social benefits with 20% of who were seeking to help their family/society/world while 42% were interested in advancing research.The majority of volunteers in the HIV vaccine trials at our site were motivated by social benefits, suggesting that altruism can be a major contributor to participation in HIV vaccine studies. Personal benefits were a secondary motivator for the volunteers. The motivators to volunteer in HIV clinical trials were similar across ages, education level and gender. Education on what is needed (including volunteer participation to develop an efficacious vaccine could be the key to greater volunteer motivation to participate in HIV vaccine

  16. ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: a multinational randomised controlled clinical trial

    DEFF Research Database (Denmark)

    Boysen, Gudrun; Krarup, Lars-Henrik; Zeng, Xianrong

    2009-01-01

    training programme before discharge and at five follow-up visits during 24 months. Control patients had follow-up visits with the same frequency but without instructions in physical activity. MAIN OUTCOME MEASURES: Physical activity assessed with the Physical Activity Scale for the Elderly (PASE) at each......OBJECTIVES: To investigate if repeated verbal instructions about physical activity to patients with ischaemic stroke could increase long term physical activity. DESIGN: Multicentre, multinational, randomised clinical trial with masked outcome assessment. SETTING: Stroke units in Denmark, China...... infarction, or falls and fractures. CONCLUSION: Repeated encouragement and verbal instruction in being physically active did not lead to a significant increase in physical activity measured by the PASE score. More intensive strategies seem to be needed to promote physical activity after ischaemic stroke...

  17. Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population.

    Science.gov (United States)

    Darbyshire, Julie Lorraine; Price, Hermione Clare

    2012-01-01

    To identify the most appropriate format for results dissemination to maximise understanding of trial results. Qualitative. Of the original 58 4-T trial centres, 34 agreed to take part in this ancillary research. All participants from these centres were eligible. All 343 participants were sent questionnaires. The low response rate meant that we were unable to make any firm conclusions about the patients' preferred method of dissemination; however, we were able to comment on the level of understanding demonstrated by the trial participants. All 40 (12%) returned questionnaires were received from 15 centres. We received no questionnaires from over half of the centres. The questionnaires which were returned demonstrated broad satisfaction with the results letter, general enthusiasm for the trial and a variable level of understanding of the results; however, there was a high proportion of responders who were not clear on why the research was undertaken or what the results meant. The low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres. From this we deduce that rapid dissemination of results is needed if it is to have any impact at all. The responders are likely to reflect a biased cohort who were both enthusiastic about the research and who had a good experience during their 3 years in the 4-T trial. It is perhaps not surprising therefore that the overview is positive. That this population was still not fully informed about the purpose of the research would seem to confirm a low level of understanding among the general public which we suggest should be addressed during the consent process.

  18. Facebook advertising for participant recruitment into a blood pressure clinical trial.

    Science.gov (United States)

    Nash, Erin L; Gilroy, Deborah; Srikusalanukul, Wichat; Abhayaratna, Walter P; Stanton, Tony; Mitchell, Geoffrey; Stowasser, Michael; Sharman, James E

    2017-12-01

    Recruitment of sufficient sample size into clinical trials is challenging. Conventional advertising methods are expensive and are often ineffective. The effectiveness of Facebook for recruitment into blood pressure clinical trials of middle-to-older-aged people is unknown. This study aimed to assess this by comparing Facebook advertising with conventional recruitment methods from a retrospective analysis within a clinical trial. Conventional advertisements (newspaper, radio and posters) were employed for the first 20 months of a randomized controlled clinical trial conducted in three Australian capital cities from Tasmania, Queensland and the Australian Capital Territory. With dwindling participant recruitment, at 20 months a Facebook advertising campaign was employed intermittently over a 4-month period. Recruitment results were retrospectively compared with those using conventional methods in the previous 4 months. Compared with conventional recruitment methods, Facebook advertisement was associated with a significant increase in the number of participants recruited in the Australian Capital Territory (from an average 1.8-7.3/month; P advertisement was associated with a significant decrease in the age of participants enquiring into the study (from 60.9 to 58.7 years; P advertising was successful in helping to increase recruitment of middle-to-older aged participants into a blood pressure clinical trial, although there may be some variability in effect that is dependent on location.

  19. Art participation for psychosocial wellbeing during stroke rehabilitation: a feasibility randomised controlled trial.

    Science.gov (United States)

    Morris, Jacqui H; Kelly, Chris; Joice, Sara; Kroll, Thilo; Mead, Gillian; Donnan, Peter; Toma, Madalina; Williams, Brian

    2017-08-30

    To examine the feasibility of undertaking a pragmatic single-blind randomised controlled trial (RCT) of a visual arts participation programme to evaluate effects on survivor wellbeing within stroke rehabilitation. Stroke survivors receiving in-patient rehabilitation were randomised to receive eight art participation sessions (n = 41) or usual care (n = 40). Recruitment, retention, preference for art participation and change in selected outcomes were evaluated at end of intervention outcome assessment and three-month follow-up. Of 315 potentially eligible participants 81 (29%) were recruited. 88% (n = 71) completed outcome and 77% (n = 62) follow-up assessments. Of eight intervention group non-completers, six had no preference for art participation. Outcome completion varied between 97% and 77%. Running groups was difficult because of randomisation timing. Effectiveness cannot be determined from this feasibility study but effects sizes suggested art participation may benefit emotional wellbeing, measured on the positive and negative affect schedule, and self-efficacy for Art (d = 0.24-0.42). Undertaking a RCT of art participation within stroke rehabilitation was feasible. Art participation may enhance self-efficacy and positively influence emotional wellbeing. These should be outcomes in a future definitive trial. A cluster RCT would ensure art groups could be reliably convened. Fewer measures, and better retention strategies are required. Implications for Rehabilitation This feasibility randomised controlled trial (RCT) showed that recruiting and retaining stroke survivors in an RCT of a visual arts participation intervention within stroke rehabilitation was feasible. Preference to participate in art activities may influence recruitment and drop-out rates, and should be addressed and evaluated fully. Art participation as part of rehabilitation may improve some aspects of post-stroke wellbeing, including positive affect and self-efficacy for art

  20. Repeated testing improves achievement in a blended learning approach for risk competence training of medical students: results of a randomized controlled trial.

    Science.gov (United States)

    Spreckelsen, C; Juenger, J

    2017-09-26

    Adequate estimation and communication of risks is a critical competence of physicians. Due to an evident lack of these competences, effective training addressing risk competence during medical education is needed. Test-enhanced learning has been shown to produce marked effects on achievements. This study aimed to investigate the effect of repeated tests implemented on top of a blended learning program for risk competence. We introduced a blended-learning curriculum for risk estimation and risk communication based on a set of operationalized learning objectives, which was integrated into a mandatory course "Evidence-based Medicine" for third-year students. A randomized controlled trial addressed the effect of repeated testing on achievement as measured by the students' pre- and post-training score (nine multiple-choice items). Basic numeracy and statistical literacy were assessed at baseline. Analysis relied on descriptive statistics (histograms, box plots, scatter plots, and summary of descriptive measures), bootstrapped confidence intervals, analysis of covariance (ANCOVA), and effect sizes (Cohen's d, r) based on adjusted means and standard deviations. All of the 114 students enrolled in the course consented to take part in the study and were assigned to either the intervention or control group (both: n = 57) by balanced randomization. Five participants dropped out due to non-compliance (control: 4, intervention: 1). Both groups profited considerably from the program in general (Cohen's d for overall pre vs. post scores: 2.61). Repeated testing yielded an additional positive effect: while the covariate (baseline score) exhibits no relation to the post-intervention score, F(1, 106) = 2.88, p > .05, there was a significant effect of the intervention (repeated tests scenario) on learning achievement, F(1106) = 12.72, p blended learning approach can be improved significantly by implementing a test-enhanced learning design, namely repeated testing. As

  1. Addressing dichotomous data for participants excluded from trial analysis: a guide for systematic reviewers.

    Directory of Open Access Journals (Sweden)

    Elie A Akl

    Full Text Available Systematic reviewer authors intending to include all randomized participants in their meta-analyses need to make assumptions about the outcomes of participants with missing data.The objective of this paper is to provide systematic reviewer authors with a relatively simple guidance for addressing dichotomous data for participants excluded from analyses of randomized trials.This guide is based on a review of the Cochrane handbook and published methodological research. The guide deals with participants excluded from the analysis who were considered 'non-adherent to the protocol' but for whom data are available, and participants with missing data.Systematic reviewer authors should include data from 'non-adherent' participants excluded from the primary study authors' analysis but for whom data are available. For missing, unavailable participant data, authors may conduct a complete case analysis (excluding those with missing data as the primary analysis. Alternatively, they may conduct a primary analysis that makes plausible assumptions about the outcomes of participants with missing data. When the primary analysis suggests important benefit, sensitivity meta-analyses using relatively extreme assumptions that may vary in plausibility can inform the extent to which risk of bias impacts the confidence in the results of the primary analysis. The more plausible assumptions draw on the outcome event rates within the trial or in all trials included in the meta-analysis. The proposed guide does not take into account the uncertainty associated with assumed events.This guide proposes methods for handling participants excluded from analyses of randomized trials. These methods can help in establishing the extent to which risk of bias impacts meta-analysis results.

  2. Falls Assessment Clinical Trial (FACT: design, interventions, recruitment strategies and participant characteristics

    Directory of Open Access Journals (Sweden)

    Lawton Beverley

    2007-07-01

    Full Text Available Abstract Background Guidelines recommend multifactorial intervention programmes to prevent falls in older adults but there are few randomised controlled trials in a real life health care setting. We describe the rationale, intervention, study design, recruitment strategies and baseline characteristics of participants in a randomised controlled trial of a multifactorial falls prevention programme in primary health care. Methods Participants are patients from 19 primary care practices in Hutt Valley, New Zealand aged 75 years and over who have fallen in the past year and live independently. Two recruitment strategies were used – waiting room screening and practice mail-out. Intervention participants receive a community based nurse assessment of falls and fracture risk factors, home hazards, referral to appropriate community interventions, and strength and balance exercise programme. Control participants receive usual care and social visits. Outcome measures include number of falls and injuries over 12 months, balance, strength, falls efficacy, activities of daily living, quality of life, and physical activity levels. Results 312 participants were recruited (69% women. Of those who had fallen, 58% of people screened in the practice waiting rooms and 40% when screened by practice letter were willing to participate. Characteristics of participants recruited using the two methods are similar (p > 0.05. Mean age of all participants was 81 years (SD 5. On average participants have 7 medical conditions, take 5.5 medications (29% on psychotropics with a median of 2 falls (interquartile range 1, 3 in the previous year. Conclusion The two recruitment strategies and the community based intervention delivery were feasible and successful, identifying a high risk group with multiple falls. Recruitment in the waiting room gave higher response rates but was less efficient than practice mail-out. Testing the effectiveness of an evidence based intervention in a

  3. Participant demographics reported in "Table 1" of randomised controlled trials: a case of "inverse evidence"?

    Directory of Open Access Journals (Sweden)

    Furler John

    2012-03-01

    Full Text Available Abstract Introduction Data supporting external validity of trial results allows clinicians to assess the applicability of a study's findings to their practice population. Socio-economic status (SES of trial participants may be critical to external validity given the relationship between social and economic circumstances and health. We explored how this is documented in reports of RCTs in four major general medical journals. Methods The contents lists of four leading general medical journals were hand searched to identify 25 consecutive papers reporting RCT results in each journal (n = 100. Data on demographic characteristics were extracted from each paper's Table 1 only (or equivalent. Results Authors infrequently reported key demographic characteristics relating to SES of RCT participants. Age and gender of participants were commonly reported. Less than 10% reported occupational group, employment status, income or area based measures of disadvantage. Conclusions Without adequate reporting of key indicators of SES in trial participants it is unclear if lower SES groups are under-represented. If such groups are systematically under-recruited into trials, this may limit the external validity and applicability of study findings to these groups. This is in spite of the higher health-care need in more disadvantaged populations. Under-representation of low SES groups could underestimate the reported effect of an intervention for those with a higher baseline risk. The marginal benefit identified in a trial with poor or no representation of lower SES participants could significantly underestimate the potential benefit to a low SES community. More transparency in this reporting and greater attention to the impact of SES on intervention outcomes in clinical trials is needed. This could be considered in the next revision of the CONSORT statement.

  4. A randomized, controlled trial of team-based competition to increase learner participation in quality-improvement education.

    Science.gov (United States)

    Scales, Charles D; Moin, Tannaz; Fink, Arlene; Berry, Sandra H; Afsar-Manesh, Nasim; Mangione, Carol M; Kerfoot, B Price

    2016-04-01

    Several barriers challenge resident engagement in learning quality improvement (QI). We investigated whether the incorporation of team-based game mechanics into an evidence-based online learning platform could increase resident participation in a QI curriculum. Randomized, controlled trial. Tertiary-care medical center residency training programs. Resident physicians (n = 422) from nine training programs (anesthesia, emergency medicine, family medicine, internal medicine, ophthalmology, orthopedics, pediatrics, psychiatry and general surgery) randomly allocated to a team competition environment (n = 200) or the control group (n = 222). Specialty-based team assignment with leaderboards to foster competition, and alias assignment to de-identify individual participants. Participation in online learning, as measured by percentage of questions attempted (primary outcome) and additional secondary measures of engagement (i.e. response time). Changes in participation measures over time between groups were assessed with a repeated measures ANOVA framework. Residents in the intervention arm demonstrated greater participation than the control group. The percentage of questions attempted at least once was greater in the competition group (79% [SD ± 32] versus control, 68% [SD ± 37], P= 0.03). Median response time was faster in the competition group (P= 0.006). Differences in participation continued to increase over the duration of the intervention, as measured by average response time and cumulative percent of questions attempted (each Ponline course delivering QI content. Medical educators should consider game mechanics to optimize participation when designing learning experiences. Published by Oxford University Press in association with the International Society for Quality in Health Care 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  5. Estimation of treatment preference effects in clinical trials when some participants are indifferent to treatment choice

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    Stephen D. Walter

    2017-02-01

    Full Text Available Abstract Background In the two-stage randomised trial design, a randomly sampled subset of study participants are permitted to choose their own treatment, while the remaining participants are randomised to treatment in the usual way. Appropriate analysis of the data from both arms of the study allows investigators to estimate the impact on study outcomes of treatment preferences that patients may have, in addition to evaluating the usual direct effect of treatment. In earlier work, we showed how to optimise this design by making a suitable choice of the proportion of participants who should be assigned to the choice arm of the trial. However, we ignored the possibility of some participants being indifferent to the treatments under study. In this paper, we extend our earlier work to consider the analysis of two-stage randomised trials when some participants have no treatment preference, even if they are assigned to the choice arm and allowed to choose. Methods We compare alternative characterisations of the response profiles of the indifferent or undecided participants, and derive estimates of the treatment and preference effects on study outcomes. We also present corresponding test statistics for these parameters. The methods are illustrated with data from a clinical trial contrasting medical and surgical interventions. Results Expressions are obtained to estimate and test the impact of treatment choices on study outcomes, as well as the impact of the actual treatment received. Contrasts are defined between patients with stated treatment preferences and those with no preference. Alternative assumptions concerning the outcomes of undecided participants are described, and an approach leading to unbiased estimation and testing is identified. Conclusions Use of the two-stage design can provide important insights into determinants of study outcomes that are not identifiable with other designs. The design can remain attractive even in the presence of

  6. Dialectical behavior therapy for adolescents with repeated suicidal and self-harming behavior: a randomized trial.

    Science.gov (United States)

    Mehlum, Lars; Tørmoen, Anita J; Ramberg, Maria; Haga, Egil; Diep, Lien M; Laberg, Stine; Larsson, Bo S; Stanley, Barbara H; Miller, Alec L; Sund, Anne M; Grøholt, Berit

    2014-10-01

    We examined whether a shortened form of dialectical behavior therapy, dialectical behavior therapy for adolescents (DBT-A) is more effective than enhanced usual care (EUC) to reduce self-harm in adolescents. This was a randomized study of 77 adolescents with recent and repetitive self-harm treated at community child and adolescent psychiatric outpatient clinics who were randomly allocated to either DBT-A or EUC. Assessments of self-harm, suicidal ideation, depression, hopelessness, and symptoms of borderline personality disorder were made at baseline and after 9, 15, and 19 weeks (end of trial period), and frequency of hospitalizations and emergency department visits over the trial period were recorded. Treatment retention was generally good in both treatment conditions, and the use of emergency services was low. DBT-A was superior to EUC in reducing self-harm, suicidal ideation, and depressive symptoms. Effect sizes were large for treatment outcomes in patients who received DBT-A, whereas effect sizes were small for outcomes in patients receiving EUC. Total number of treatment contacts was found to be a partial mediator of the association between treatment and changes in the severity of suicidal ideation, whereas no mediation effects were found on the other outcomes or for total treatment time. DBT-A may be an effective intervention to reduce self-harm, suicidal ideation, and depression in adolescents with repetitive self-harming behavior. Clinical trial registration information-Treatment for Adolescents With Deliberate Self Harm; http://ClinicalTrials.gov/; NCT00675129. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  7. Beyond the checklist: assessing understanding for HIV vaccine trial participation in South Africa.

    Science.gov (United States)

    Lindegger, Graham; Milford, Cecilia; Slack, Catherine; Quayle, Michael; Xaba, Xolani; Vardas, Eftyhia

    2006-12-15

    Informed consent and understanding are essential ethical requirements for clinical trial participation. Traditional binary measures of understanding may be limited and not be the best measures of level of understanding. This study designed and compared 4 measures of understanding for potential participants being prepared for enrollment in South African HIV vaccine trials, using detailed operational scoring criteria. Assessment of understanding of 7 key trial components was compared via self-report, checklist, vignettes, and narrative measures. Fifty-nine participants, including members of vaccine preparedness groups and 1 HIV vaccine trial, took part. There were significant differences across the measures for understanding of 5 components and for overall understanding. Highest scores were obtained on self-report and checklist measures, and lowest scores were obtained for vignettes and narrative descriptions. The findings suggest that levels of measured understanding are dependent on the tools used. Forced-choice measures like checklists tend to yield higher scores than open-ended measures like narratives or vignettes. Consideration should be given to complementing checklists and self-reports with open-ended measures, particularly for critical trial concepts, where the consequences of misunderstanding are potentially severe.

  8. Why providers participate in clinical trials: considering the National Cancer Institute's Community Clinical Oncology Program.

    Science.gov (United States)

    McAlearney, Ann Scheck; Song, Paula H; Reiter, Kristin L

    2012-11-01

    The translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute's Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP participation involves unsubsidized costs and organizational challenges that raise concerns about sustained provider participation in clinical trials. This study was designed to improve our understanding of why providers participate in the CCOP in order to inform the decision-making process of administrators, clinicians, organizations, and policy-makers considering CCOP participation. We conducted a multi-site qualitative study of five provider organizations engaged with the CCOP. We interviewed 41 administrative and clinician key informants, asking about what motivated CCOP participation, and what benefits they associated with involvement. We deductively and inductively analyzed verbatim interview transcripts, and explored themes that emerged. Interviewees expressed both "altruistic" and "self-interested" motives for CCOP participation. Altruistic reasons included a desire to increase access to clinical trials and feeling an obligation to patients. Self-interested reasons included the desire to enhance reputation, and a need to integrate disparate cancer care activities. Perceived benefits largely matched expressed motives for CCOP participation, and included internal and external benefits to the organization, and quality of care benefits for both patients and participating physicians. The motives and benefits providers attributed to CCOP participation are consistent with translational research goals, offering evidence that participation can contribute value to providers by expanding access to innovative medical care for patients in need. Copyright © 2012 Elsevier Inc. All rights reserved.

  9. A Randomized Trial to Evaluate the Effect of Local Endometrial Injury on the Clinical Pregnancy Rate of Frozen Embryo Transfer Cycles in Patients With Repeated Implantation Failure

    Directory of Open Access Journals (Sweden)

    Ensieh Shahrokh-Tehraninejad

    2016-12-01

    Full Text Available Objective: Repeated implantation failure (RIF is a condition in which the embryos implantation decreases in the endometrium. So, our aim was to evaluate the effect of local endometrial injury on embryo transfer results.Materials and methods: In this simple randomized clinical trial (RCT, a total of 120 patients were selected. The participants were less than 40 years old, and they are in their minimum two cycles of vitro fertilization (IVF. Patients were divided randomly into two groups of LEI (Local endometrial injury and a control group (n = 60 in each group. The first group had four small endometrial injuries from anterior, posterior, and lateral uterus walls which were obtained from people who were in 21th day of their previous IVF cycle. The second group was the patients who have not received any intervention.Results: The experimental and control patients were matched in the following factors. Regarding the clinical pregnancy rate, there was no significant difference noted between the experimental and the control group.Conclusion: Local endometrial injury in a preceding cycle does not increase the clinical pregnancy rate in the subsequent FET cycle of patients with repeated implantation failure.

  10. What attitudes and beliefs underlie patients' decisions about participating in chemotherapy trials?

    Science.gov (United States)

    Sutherland, H J; da Cunha, R; Lockwood, G A; Till, J E

    1998-01-01

    The theory of reasoned action, which postulates that personal attitudes and external social influences predict intentions to undertake a behavior, was used as a conceptual framework for developing a questionnaire to elicit beliefs and attitudes associated with the decision to participate in a hypothetical cancer chemotherapy trial. After completing the questionnaire, two-thirds of the 150 respondents indicated they would enroll in such a trial if it were available. Considerable variation existed in both "universal" and "trial-specific" beliefs and attitudes underpinning their intentions. A substantial amount of the variance in "intention" to participate was explained by "attitude" alone (75%). Social influences, although statistically significant, made a mere 1% additional contribution. One interpretation is that subjective expected-utility theory, which essentially predicts beliefs or "attitude," is a better model. The authors conclude that both theories may be criticized regarding how well they capture the rationality and nuances of decision behavior.

  11. Sensation seeking amongst healthy volunteers participating in phase I clinical trials.

    Science.gov (United States)

    Farré, M; Lamas, X; Camí, J

    1995-01-01

    1. Phase I clinical trials are usually carried out in healthy volunteers. In addition to economic gain, factors that may influence willingness to participate include scientific interest, curiosity and choice for risky activities. 2. We assessed the relationship between personality variables and volunteering for clinical pharmacology research. Two personality questionnaires, the Sensation Seeking Scale (SSS, form V) and the Eysenck Personality Questionnaire (EPQ), were administered to 48 male healthy university students who volunteered to participate in a phase I clinical trial and to 43 male university students who were not willing to participate in phase I clinical trials. General norm data were also used for the comparison of results. 3. When healthy volunteers were compared with unwilling subjects, significant differences were found in thrill-and-adventure seeking (7.9 vs 6.7, P = 0.0034), experience seeking (6.4 vs 5.2, P = 0.0012), disinhibition (6.2 vs 4.3, P personality profile of healthy volunteers was characterized by a higher sensation seeking trait and extraversion as compared with individuals who were not willing to participate in phase I clinical trials and general norm data. PMID:7640147

  12. Tocolysis for repeat external cephalic version in breech presentation at term: a randomised, double-blinded, placebo-controlled trial.

    Science.gov (United States)

    Impey, Lawrence; Pandit, Meghana

    2005-05-01

    External cephalic version (ECV) reduces the incidence of breech presentation at term and caesarean section for non-cephalic births. Tocolytics may improve success rates, but are time consuming, may cause side effects and have not been proven to alter caesarean section rates. The aim of this trial was to determine whether tocolysis should be used if ECV is being re-attempted after a failed attempt. To determine whether tocolysis should be used if ECV is being re-attempted after a failed attempt. Randomised, double-blinded, placebo-controlled trial. UK teaching hospital. One hundred and twenty-four women with a breech presentation at term who had undergone an unsuccessful attempt at ECV. Relative risks with 95% confidence intervals for categorical variables and a t test for continuous variables. Analysis was by intention to treat. Incidence of cephalic presentation at delivery. Secondary outcomes were caesarean section and measures of neonatal and maternal morbidity. The use of tocolysis for a repeat attempt at ECV significantly increases the incidence of cephalic presentation at delivery (RR 3.21; 95% CI 1.23-8.39) and reduces the incidence of caesarean section (RR 0.33; 95% CI 0.14-0.80). The effects were most marked in multiparous women (RR for cephalic presentation at delivery 9.38; 95% CI 1.64-53.62). Maternal and neonatal morbidity remain unchanged. The use of tocolysis increases the success rate of repeat ECV and reduces the incidence of caesarean section. A policy of only using tocolysis where an initial attempt has failed leads to a relatively high success rate with minimum usage of tocolysis.

  13. Dataset of acute repeated sessions of bifrontal transcranial direct current stimulation for treatment of intractable tinnitus: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ali Yadollahpour

    2017-12-01

    Full Text Available Transcranial direct current stimulation (tDCS has reportedly shown promising therapeutic effects for tinnitus (Forogh et al., 2016; Joos et al., 2014 [1,2]. Studies are ongoing to determine optimum treatment protocol and the site of stimulation. Findings of the early studies are heterogeneous and most studies have focused on single session tDCS and short follow-up periods. There is no study on repeated sessions of tDCS with long term follow-up. This study presents the results of a randomized clinical trial investigating the therapeutic effects of acute multi-session tDCS over dorsolateral prefrontal cortex (DLPFC on tinnitus symptoms and comorbid depression and anxiety in patients with chronic intractable tinnitus. The dataset includes the demographic information, audiometric assessments, tinnitus specific characteristics, and the response variables of the study. The response variables included the scores of tinnitus handicap inventory (THI, tinnitus loudness and tinnitus related distress based on 0–10 numerical visual analogue scale (VAS scores, beck depression inventory (BDI-II and beck anxiety inventory (BAI scores. The dataset included the scores of THI pre and immediately post intervention, and at one month follow-up; the tinnitus loudness and distress scores prior to intervention, and immediately, one hour, one week, and at one month after the last stimulation session. In addition, the BDI-II, and BAI scores pre and post intervention are included. The data of the real (n=25 and sham tDCS (n=17 groups are reported. The main manuscript of this dataset is 'Acute repeated sessions of bifrontal transcranial direct current stimulation for treatment of intractable tinnitus: a randomized controlled trial' (Bayat et al., submitted for publication [3]. Keywords: Transcranial direct current stimulation, Acute stimulations, Tinnitus, Depression, Anxiety, DLPFC

  14. At what price? A cost-effectiveness analysis comparing trial of labour after previous caesarean versus elective repeat caesarean delivery.

    Directory of Open Access Journals (Sweden)

    Christopher G Fawsitt

    Full Text Available BACKGROUND: Elective repeat caesarean delivery (ERCD rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland. METHODS: Using a decision analytic model, a cost-effectiveness analysis (CEA was performed where the measure of health gain was quality-adjusted life years (QALYs over a six-week time horizon. A review of international literature was conducted to derive representative estimates of adverse maternal health outcomes following a trial of labour after caesarean (TOLAC and ERCD. Delivery/procedure costs derived from primary data collection and combined both "bottom-up" and "top-down" costing estimations. RESULTS: Maternal morbidities emerged in twice as many cases in the TOLAC group than the ERCD group. However, a TOLAC was found to be the most-effective method of delivery because it was substantially less expensive than ERCD (€ 1,835.06 versus € 4,039.87 per women, respectively, and QALYs were modestly higher (0.84 versus 0.70. Our findings were supported by probabilistic sensitivity analysis. CONCLUSIONS: Clinicians need to be well informed of the benefits and risks of TOLAC among low risk women. Ideally, clinician-patient discourse would address differences in length of hospital stay and postpartum recovery time. While it is premature advocate a policy of TOLAC across maternity units, the results of the study prompt further analysis and repeat iterations, encouraging future studies to synthesis previous research and new and relevant evidence under a single

  15. Effect of e-Learning and Repeated Performance Feedback on Spirometry Test Quality in Family Practice: A Cluster Trial

    Science.gov (United States)

    Schermer, Tjard R.; Akkermans, Reinier P.; Crockett, Alan J.; van Montfort, Marian; Grootens-Stekelenburg, Joke; Stout, Jim W.; Pieters, Willem

    2011-01-01

    PURPOSE Spirometry has become an indispensable tool in primary care to exclude, diagnose, and monitor chronic respiratory conditions, but the quality of spirometry tests in family practices is a reason for concern. Aim of this study was to investigate whether a combination of e-learning and bimonthly performance feedback would improve spirometry test quality in family practices in the course of 1 year. METHODS Our study was a cluster trial with 19 family practices allocated to intervention or control conditions through minimization. Intervention consisted of e-learning and bimonthly feedback reports to practice nurses. Control practices received only the joint baseline workshop. Spirometry quality was assessed by independent lung function technicians. Two outcomes were defined, with the difference between rates of tests with 2 acceptable and repeatable blows being the primary outcome and the difference between rates of tests with 2 acceptable blows being the secondary outcome. We used multilevel logistic regression analysis to calculate odds ratios (ORs) for an adequate test in intervention group practices. RESULTS We analyzed 1,135 tests. Rate of adequate tests was 33% in intervention and 30% in control group practices (OR = 1.3; P=.605). Adequacy of tests did not differ between groups but tended to increase with time: OR = 2.2 (P = .057) after 3 and OR = 2.0 (P = .086) in intervention group practices after 4 feedback reports. When ignoring test repeatability, these differences between the groups were slightly more pronounced: OR = 2.4 (P = .033) after 3 and OR=2.2 (P = .051) after 4 feedback reports. CONCLUSIONS In the course of 1 year, we observed a small and late effect of e-learning and repeated feedback on the quality of spirometry as performed by family practice nurses. This intervention does not seem to compensate the lack of rigorous training and experience in performing spirometry tests in most practices. PMID:21747104

  16. Effect of e-learning and repeated performance feedback on spirometry test quality in family practice: a cluster trial.

    Science.gov (United States)

    Schermer, Tjard R; Akkermans, Reinier P; Crockett, Alan J; van Montfort, Marian; Grootens-Stekelenburg, Joke; Stout, Jim W; Pieters, Willem

    2011-01-01

    Spirometry has become an indispensable tool in primary care to exclude, diagnose, and monitor chronic respiratory conditions, but the quality of spirometry tests in family practices is a reason for concern. Aim of this study was to investigate whether a combination of e-learning and bimonthly performance feedback would improve spirometry test quality in family practices in the course of 1 year. Our study was a cluster trial with 19 family practices allocated to intervention or control conditions through minimization. Intervention consisted of e-learning and bimonthly feedback reports to practice nurses. Control practices received only the joint baseline workshop. Spirometry quality was assessed by independent lung function technicians. Two outcomes were defined, with the difference between rates of tests with 2 acceptable and repeatable blows being the primary outcome and the difference between rates of tests with 2 acceptable blows being the secondary outcome. We used multilevel logistic regression analysis to calculate odds ratios (ORs) for an adequate test in intervention group practices. We analyzed 1,135 tests. Rate of adequate tests was 33% in intervention and 30% in control group practices (OR = 1.3; P=.605). Adequacy of tests did not differ between groups but tended to increase with time: OR = 2.2 (P = .057) after 3 and OR = 2.0 (P = .086) in intervention group practices after 4 feedback reports. When ignoring test repeatability, these differences between the groups were slightly more pronounced: OR = 2.4 (P = .033) after 3 and OR=2.2 (P = .051) after 4 feedback reports. In the course of 1 year, we observed a small and late effect of e-learning and repeated feedback on the quality of spirometry as performed by family practice nurses. This intervention does not seem to compensate the lack of rigorous training and experience in performing spirometry tests in most practices.

  17. Attitudes and expectations of patients with neuromuscular diseases about their participation in a clinical trial.

    Science.gov (United States)

    Gargiulo, M; Herson, A; Michon, C C; Hogrel, J Y; Doppler, V; Laloui, K; Herson, S; Payan, C; Eymard, B; Laforêt, P

    2013-01-01

    This study aimed to gain a better understanding of the psychological impact of participating in a clinical trial for patients with Pompe disease (Acid Maltase Deficiency). Attitudes and expectations of adult patients with neuromuscular diseases regarding medical trials are as yet unreported. In order to learn about the psychological consequences of participating in a clinical trial, we conducted a prospective assessment of patients with late-onset Pompe Disease, a rare genetic condition, for which no treatment had been available before. This psychological study was carried out as an ancillary study to the randomized double-blind placebo-controlled trial described elsewhere (van der Ploeg et al., 2010). We assessed patients (n=8) at inclusion, and at 12 and 18 months for six psychological dimensions: depression (Beck Depression Inventory, BDI), hopelessness (Beck Hopelessness Scale, BHS), anxiety (STAI A-B), quality of life (Whoqol-26), social adjustment (S.A.S-self-report) and locus of control (IPC Levenson). We produced a self-administered questionnaire in order to assess the attitudes, motivations and expectations of patients during the trial. At 12 months, mean social adjustment (SAS-SR, P=0.02) had improved, and at 18 months mean depression score had improved as well (BDI, P=0.03). The quality of life of patients (Whoqol-26) remained unchanged. Throughout the study, patients were more likely to have an internal locus of control than an external one (IPC Levenson). The self-administered questionnaire showed that patients' expectations were disproportionate compared to the medical information they had received starting the trial. For all patients, the first motivation for being enrolled in a clinical trial was "to help research", for half of them the motivation was to "improve their health". Whether patients believed to be part of one group or another (placebo or treatment) depended on their subjective perception of improvement during the trial. Given the small

  18. Predicting Participant Consent in mHealth Trials – A Caregiver’s Perspective

    Directory of Open Access Journals (Sweden)

    Yvonne O'Connor

    2017-11-01

    Full Text Available Informed consent is sought prior to conducting a healthcare intervention on a person. When a healthcare intervention involves a young child, their caregiver is required to provide informed consent on their behalf. However, little is known on the behavioural intentions of participants to provide consent when a mobile health (mHealth intervention is involved in a clinical trial scenario. Understanding this phenomenon is important, without consent appropriate data may not be collected to empirically examine the implications of mHealth initiatives when delivering healthcare services to children in a ‘real world context’. The objective of this paper is to explore the behavioural intentions of caregivers to provide consent for children (under five years of age to participate in mHealth Randomised Control Trials (RCT in developing countries and subsequently develop a predictive model for consent giving. Data was captured vis-à-vis interviews with Malawian caregivers in Africa. The findings reveal that emotional response stimuli play a major role during the participant informed consent process resulting in the involvement (or not of a child within an RCT. The study contributes to, and opens up, avenues for critical research on the role of informed consent as part of RCT-related projects, especially concerning the involvement of children. This new knowledge may be leveraged to address participant uncertainties and subsequently improve the rate of paediatric recruitment in mHealth trial scenarios.

  19. Assessment of clinical trial participant patient satisfaction: a call to action.

    Science.gov (United States)

    Pflugeisen, Bethann Mangel; Rebar, Stacie; Reedy, Anne; Pierce, Roslyn; Amoroso, Paul J

    2016-10-06

    As patient satisfaction scores become increasingly relevant in today's health care market, we sought to evaluate satisfaction of the unique subset of patients enrolling in clinical trials in a research facility embedded within a community hospital system. We developed and deployed a patient satisfaction survey tailored to clinical trial patients who consented to and/or completed a clinical trial in our research institute in the prior year. The survey was distributed to 222 patients. Likert scale responses were analyzed using top box and percentile rank procedures. Correlation analysis was used to evaluate associations between the clinical trial experience and intent to return to our system for routine care. Ninety surveys were returned in the 6 months following the mailing for a 41 % response rate; the bulk of these (N = 81) were returned within 6 weeks of the mailing. The questions with the highest ranking responses were related to interactions with staff (84th percentile or higher). Fifty-one point one percent of patients (64th percentile) strongly agreed that they would seek future care in our system. Patient intent to return to the provider seen during the clinical trial was most highly correlated with intent to seek future care within our system (r = 0.54, p system-based clinical trials and the relationship between clinical trial participation and perception of the healthcare system as a desirable resource for routine medical care. We argue that this work is invaluable to the research community and submit a call to action to our peers to begin systematic evaluation of clinical trial patient satisfaction.

  20. Does participating in a clinical trial affect subsequent nursing management? Post-trial care for participants recruited to the INTACT pressure ulcer prevention trial: A follow-up study.

    Science.gov (United States)

    Webster, Joan; Bucknall, Tracey; Wallis, Marianne; McInnes, Elizabeth; Roberts, Shelley; Chaboyer, Wendy

    2017-06-01

    Participation in a clinical trial is believed to benefit patients but little is known about the post-trial effects on routine hospital-based care. To describe (1) hospital-based, pressure ulcer care-processes after patients were discharged from a pressure ulcer prevention, cluster randomised controlled trial; and (2) to investigate if the trial intervention had any impact on subsequent hospital-based care. We conducted a retrospective analysis of 133 trial participants who developed a pressure ulcer during the clinical trial. We compared outcomes and care processes between participants who received the pressure ulcer prevention intervention and those in the usual care, control group. We also compared care processes according to the pressure ulcer stage. A repositioning schedule was reported for 19 (14.3%) patients; 33 (24.8%) had a dressing applied to the pressure ulcer; 17 (12.8) patients were assessed by a wound care team; and 20 (15.0%) were seen by an occupational therapist. Patients in the trial's intervention group were more likely to have the presence of a pressure ulcer documented in their chart (odds ratio (OR) 8.18, 95% confidence intervals (CI) 3.64-18.36); to be referred to an occupational therapist OR 0.92 (95% CI 0.07; 0.54); to receive a pressure relieving device OR 0.31 (95% CI 0.14; 0.69); or a pressure relieving mattress OR 0.44 (95% CI 0.20; 0.96). Participants with Stage 2 or unstageable ulcers were more likely than others to have dressings applied to their wounds (p=pressure ulcer status and care is poor. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Participation in two phase II prophylactic HIV vaccine trials in the UK.

    Science.gov (United States)

    Gray, Kimberly; Legg, K; Sharp, A; Mackie, N; Olarinde, F; De Souza, C; Weber, J; Peters, B

    2008-06-02

    There will be a continued imperative to recruit large numbers of healthy volunteers to early phase prophylactic HIV vaccine (PHV) trials. We studied mechanisms associated with participation in two related phase II PHV trials. The most cited reasons for volunteering were altruism and a personal connection to HIV. The most successful recruiting strategies targeted organisations dealing with HIV, health or social issues, or were directed to large audiences through the mass media. However, circulated emails and word of mouth were the most resource-effective approaches. Group discussions and the collection of a pool of potential volunteers were much less effective than one-to-one discussions and immediate screening after recruitment. We utilised our findings to devise key recommendations to assist PHV trial teams who are planning future studies.

  2. Industry and Patient Perspectives on Child Participation in Clinical Trials: The Pediatric Assent Initiative Survey Report.

    Science.gov (United States)

    Lombardi, Donald; Squires, Liza; Sjostedt, Philip; Eichler, Irmgard; Turner, Mark A; Thompson, Charles

    2018-01-01

    Obtaining assent from children participating in clinical trials acknowledges autonomy and developmental ability to contribute to the consent process. This critical step in pediatric drug development remains poorly understood, with significant room for improving the clarity, efficiency, and implementation of the assent process. Beyond ethical necessity of informing children about their treatment, the assent process provides the advantages of including children in discussions about their diagnosis and treatment-allowing greater understanding of interventions included in the study. A formalized assent process acknowledges the child as a volunteer and provides a forum for questions and feedback. Legal, cultural, and social differences have historically prevented the development of clear, concise, and accessible materials to ensure children understand the clinical trial design. Published guidelines on obtaining pediatric assent are vague, with many decisions left to local institutional review boards and ethics committees, underscoring the need for collaboratively designed standards. To address this need, 2 surveys were conducted to quantify perspectives on assent in pediatric clinical trials. Two digital surveys were circulated in the United States and internationally (October 2014 to January 2015). The first survey targeted children, parents, and/or caregivers. The second polled clinical trial professionals on their organizations' experience and policies regarding pediatric assent. Forty-five respondents completed the child and parent/caregiver survey; 57 respondents completed the industry survey. Respondents from both surveys detailed experiences with clinical trials and the impediments to securing assent, offering potential solutions to attaining assent in pediatric patients. An important opportunity exists for standardized practices and tools to ensure pediatric patients make well-informed decisions regarding their participation in clinical trials, using materials

  3. Diagnostic conversion to bipolar disorder in unipolar depressed patients participating in trials on antidepressants

    DEFF Research Database (Denmark)

    Holmskov, J; Licht, R W; Andersen, K

    2017-01-01

    OBJECTIVE: In unipolar depressed patients participating in trials on antidepressants, we investigated if illness characteristics at baseline could predict conversion to bipolar disorder. METHOD: A long-term register-based follow-up study of 290 unipolar depressed patients with a mean age of 50.......8 years (SD=11.9) participating in three randomized trials on antidepressants conducted in the period 1985-1994. The independent effects of explanatory variables were examined by applying Cox regression analyses. RESULTS: The overall risk of conversion was 20.7%, with a mean follow-up time of 15.2 years...... per patient. The risk of conversion was associated with an increasing number of previous depressive episodes at baseline, [HR 1.18, 95% CI (1.10-1.26)]. No association with gender, age, age at first depressive episode, duration of baseline episode, subtype of depression or any of the investigated HAM...

  4. Enhancement of exposure therapy in participants with specific phobia: A randomized controlled trial comparing yohimbine, propranolol and placebo.

    Science.gov (United States)

    Meyerbröker, K; Morina, N; Emmelkamp, P M G

    2018-05-04

    Recent research indicates that pharmacological agents may enhance psychotherapeutic outcome. Yet, empirical results have not been conclusive with respect to two pharmacological agents, yohimbine hydrochloride (YOH) and propranolol. YOH is suggested to enhance emotional memory by elevating norepinephrine, whereas the β-adrenergic receptor antagonist propranolol might help better cope with feared situations by reducing accompanying bodily sensations. In this controlled trial, fifty-six participants with specific phobia were randomly assigned to either 1) virtual reality exposure therapy (VRET) plus YOH, 2) VRET plus Propranolol, or 3) VRET plus placebo. Participants in all conditions received three sessions of VRET over a period of two weeks. We conducted 2 × 3 repeated measures MANOVA's. Results showed a significant effect for time, with partial eta squared ranging from ηp2 = 0.647 to ηp2 = 0.692, for specific phobia, yet no significant interaction effects were found. No significant differences were found when VRET with YOH or a beta-blocker was compared to VRET with a non-active placebo. Implications for clinical practice and future research are discussed. Copyright © 2018 Elsevier Ltd. All rights reserved.

  5. Deployment Repeatability

    Science.gov (United States)

    2016-08-31

    large cohort of trials to spot unusual cases. However, deployment repeatability is inherently a nonlinear phenomenon, which makes modeling difficult...and GEMS tip position were both tracked during ground testing by a laser target tracking system. Earlier SAILMAST testing in 2005 [8] used...recalls the strategy used by SRTM, where a constellation of lights was installed at the tip of the boom and a modified star tracker was used to track tip

  6. Associations of obesogenic behaviors in mothers and obese children participating in a randomized trial

    OpenAIRE

    Sonneville, Kendrin R.; Rifas-Shiman, Sheryl L.; Kleinman, Ken; Gortmaker, Steven; Gillman, Matthew W.; Taveras, Elsie M.

    2012-01-01

    Relatively little research has assessed the association between obesogenic behaviors in parents and their children. The objective of the present analysis was to examine cross-sectional associations in television (TV)/video viewing, sugar-sweetened beverage intake, and fast food intake between mothers and their pre-school aged children. We studied baseline data among 428 participants in High Five for Kids, a randomized controlled trial of behavior change among overweight and obese children age...

  7. Attitudes and motivations regarding willingness to participate in dental clinical trials

    OpenAIRE

    Friesen, Lynn Roosa; Williams, Karen B.

    2016-01-01

    Background: This study examined attitudes about research, knowledge of the research process, reasons for and satisfaction with participation in a dental clinical trial as a function of demographic characteristics. Materials and methods: 180 adults were invited to complete a 47-item survey at the completion of a 10-week dental product study at a Midwestern academic dental center. Seven demographic items included gender, race/ethnicity, age, education, household income, location of usual den...

  8. Safety and efficacy of repeated injections of botulinum toxin A in peripheral neuropathic pain (BOTNEP): a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Attal, Nadine; de Andrade, Daniel C; Adam, Frédéric; Ranoux, Danièle; Teixeira, Manoel J; Galhardoni, Ricardo; Raicher, Irina; Üçeyler, Nurcan; Sommer, Claudia; Bouhassira, Didier

    2016-05-01

    Data from previous studies suggest that botulinum toxin A has analgesic effects against peripheral neuropathic pain, but the quality of the evidence is low. We aimed to assess the safety and efficacy of repeated administrations of botulinum toxin A in patients with neuropathic pain. We did a randomised, double-blind, placebo-controlled trial at two outpatient clinics in France (Clinical Pain Centre, Ambroise Paré Hospital, APHP, Boulogne-Billancourt, and Neurological Centre, Hôpital Dupuytren, Limoges) and one in Brazil (Neurological Department, Hospital das Clínicas da FMUSP, São Paulo). Patients aged 18-85 years with peripheral neuropathic pain were randomly assigned (1:1) by block randomisation, according to a centralised schedule, to receive two subcutaneous administrations of botulinum toxin A (up to 300 units) or placebo, 12 weeks apart. All patients and investigators were masked to treatment assignment. The primary outcome was the efficacy of botulinum toxin A versus placebo, measured as the change from baseline in self-reported mean weekly pain intensity over the course of 24 weeks from the first administration. The primary efficacy analysis was a mixed-model repeated-measures analysis in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01251211. Between Oct 2, 2010, and Aug 2, 2013, 152 patients were enrolled, of whom 68 were randomly assigned (34 per group), and 66 (37 [56%] men) were included in the primary analysis (34 in the botulinum toxin A group and 32 in the placebo group). Botulinum toxin A reduced pain intensity over 24 weeks compared with placebo (adjusted effect estimate -0·77, 95% CI -0·95 to -0·59; pbotulinum toxin A group and 17 (53%) of those in the placebo group (p=1·0). Severe pain was experienced by ten (29%) participants in the botulinum toxin A group and 11 (34%) in the placebo group (p=0·8). Two administrations of botulinum toxin A, each of which comprised several injections, have a

  9. Diagnostic conversion to bipolar disorder in unipolar depressed patients participating in trials on antidepressants.

    Science.gov (United States)

    Holmskov, J; Licht, R W; Andersen, K; Bjerregaard Stage, T; Mørkeberg Nilsson, F; Bjerregaard Stage, K; Valentin, J B; Bech, P; Ernst Nielsen, R

    2017-02-01

    In unipolar depressed patients participating in trials on antidepressants, we investigated if illness characteristics at baseline could predict conversion to bipolar disorder. A long-term register-based follow-up study of 290 unipolar depressed patients with a mean age of 50.8 years (SD=11.9) participating in three randomized trials on antidepressants conducted in the period 1985-1994. The independent effects of explanatory variables were examined by applying Cox regression analyses. The overall risk of conversion was 20.7%, with a mean follow-up time of 15.2 years per patient. The risk of conversion was associated with an increasing number of previous depressive episodes at baseline, [HR 1.18, 95% CI (1.10-1.26)]. No association with gender, age, age at first depressive episode, duration of baseline episode, subtype of depression or any of the investigated HAM-D subscales included was found. The patients were followed-up through the Danish Psychiatric Central Research Register, which resulted in inherent limitations such as possible misclassification of outcome. In a sample of middle-aged hospitalized unipolar depressed patients participating in trials on antidepressants, the risk of conversion was associated with the number of previous depressive episodes. Therefore, this study emphasizes that unipolar depressed patients experiencing a relatively high number of recurrences should be followed more closely, or at least be informed about the possible increased risk of conversion. Copyright © 2016. Published by Elsevier Masson SAS.

  10. Why do patients choose (not) to participate in an exercise trial during adjuvant chemotherapy for breast cancer?

    NARCIS (Netherlands)

    van Waart, Hanna; van Harten, Wim H.; Buffart, Laurien M.; Sonke, Gabe S.; Stuiver, Martijn M.; Aaronson, Neil K.

    2016-01-01

    Only between 25% and 50% of patients invited to participate in clinical trial-based physical exercise programs during cancer treatment agree to do so. The purpose of this study was to identify factors associated significantly with the decision (not) to participate in a randomized controlled trial of

  11. Sharing and reuse of individual participant data from clinical trials: principles and recommendations.

    Science.gov (United States)

    Ohmann, Christian; Banzi, Rita; Canham, Steve; Battaglia, Serena; Matei, Mihaela; Ariyo, Christopher; Becnel, Lauren; Bierer, Barbara; Bowers, Sarion; Clivio, Luca; Dias, Monica; Druml, Christiane; Faure, Hélène; Fenner, Martin; Galvez, Jose; Ghersi, Davina; Gluud, Christian; Groves, Trish; Houston, Paul; Karam, Ghassan; Kalra, Dipak; Knowles, Rachel L; Krleža-Jerić, Karmela; Kubiak, Christine; Kuchinke, Wolfgang; Kush, Rebecca; Lukkarinen, Ari; Marques, Pedro Silverio; Newbigging, Andrew; O'Callaghan, Jennifer; Ravaud, Philippe; Schlünder, Irene; Shanahan, Daniel; Sitter, Helmut; Spalding, Dylan; Tudur-Smith, Catrin; van Reusel, Peter; van Veen, Evert-Ben; Visser, Gerben Rienk; Wilson, Julia; Demotes-Mainard, Jacques

    2017-12-14

    We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European. We developed principles and practical recommendations on how to share data from clinical trials. The task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata. The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and

  12. Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate.

    Science.gov (United States)

    Mackay, Christine B; Antonelli, Kaitlyn R; Bruinooge, Suanna S; Saint Onge, Jarron M; Ellis, Shellie D

    2017-08-01

    The Affordable Care Act (ACA) includes a mandate requiring most private health insurers to cover routine patient care costs for cancer clinical trial participation; however, the impact of this provision on cancer centers' efforts to accrue patients to clinical trials has not been well described. First, members of cancer research centers and community-based institutions (n = 252) were surveyed to assess the status of insurance denials, and then, a focused survey (n = 77) collected denial details. Univariate and multivariate analyses were used to examine associations between the receipt of denials and site characteristics. Overall, 62.7% of the initial survey respondents reported at least 1 insurance denial during 2014. Sites using a precertification process were 3.04 times more likely to experience denials (95% confidence interval, 1.55-5.99; P ≤ .001), and similar rates of denials were reported from sites located in states with preexisting clinical trial coverage laws versus states without them (82.3% vs 85.1%; χ = 50.7; P ≤ .001). Among the focused survey sites, academic centers reported denials more often than community sites (71.4% vs 46.4%). The failure of plans to cover trial participation was cited as the most common reason provided for denials (n = 33 [80.5%]), with nearly 80% of sites (n = 61) not receiving a coverage response from the insurer within 72 hours. Despite the ACA's mandate for most insurers to cover routine care costs for cancer clinical trial participation, denials and delays continue. Denials may continue because some insurers remain exempt from the law, or they may signal an implementation failure. Delays in coverage may affect patient participation in trials. Additional efforts to eliminate this barrier will be needed to achieve federal initiatives to double the pace of cancer research over the next 5 years. Future work should assess the law's effectiveness at the patient level to inform these efforts

  13. Factors influencing participation in a vascular disease prevention lifestyle program among participants in a cluster randomized trial.

    Science.gov (United States)

    Laws, Rachel A; Fanaian, Mahnaz; Jayasinghe, Upali W; McKenzie, Suzanne; Passey, Megan; Davies, Gawaine Powell; Lyle, David; Harris, Mark F

    2013-05-31

    Previous research suggests that lifestyle intervention for the prevention of diabetes and cardiovascular disease (CVD) are effective, however little is known about factors affecting participation in such programs. This study aims to explore factors influencing levels of participation in a lifestyle modification program conducted as part of a cluster randomized controlled trial of CVD prevention in primary care. This concurrent mixed methods study used data from the intervention arm of a cluster RCT which recruited 30 practices through two rural and three urban primary care organizations. Practices were randomly allocated to intervention (n = 16) and control (n = 14) groups. In each practice up to 160 eligible patients aged between 40 and 64 years old, were invited to participate. Intervention practice staff were trained in lifestyle assessment and counseling and referred high risk patients to a lifestyle modification program (LMP) consisting of two individual and six group sessions over a nine month period. Data included a patient survey, clinical audit, practice survey on capacity for preventive care, referral and attendance records at the LMP and qualitative interviews with Intervention Officers facilitating the LMP. Multi-level logistic regression modelling was used to examine independent predictors of attendance at the LMP, supplemented with qualitative data from interviews with Intervention Officers facilitating the program. A total of 197 individuals were referred to the LMP (63% of those eligible). Over a third of patients (36.5%) referred to the LMP did not attend any sessions, with 59.4% attending at least half of the planned sessions. The only independent predictors of attendance at the program were employment status - not working (OR: 2.39 95% CI 1.15-4.94) and having high psychological distress (OR: 2.17 95% CI: 1.10-4.30). Qualitative data revealed that physical access to the program was a barrier, while GP/practice endorsement of the program and

  14. Volunteer feedback and perceptions after participation in a phase I, first-in-human Ebola vaccine trial: An anonymous survey.

    Directory of Open Access Journals (Sweden)

    Julie-Anne Dayer

    Full Text Available The continued participation of volunteers in clinical trials is crucial to advances in healthcare. Few data are available regarding the satisfaction and impressions of healthy volunteers after participation in phase I trials, many of which lead to unexpected adverse events. We report feedback from over 100 adult volunteers who took part in a first-in-human trial conducted in a high-income country testing an experimental Ebola vaccine causing significant reactogenicity, as well as unexpected arthritis in one fifth of participants. The anonymous, internet-based satisfaction survey was sent by email to all participants upon their completion of this one-year trial; it asked 24 questions concerning volunteers' motivations, impressions of the trial experience, and overall satisfaction. Answers were summarized using descriptive statistics. Of the 115 trial participants, 103 (90% filled out the survey. Fifty-five respondents (53% were male. Thirty-five respondents (34% were healthcare workers, many of whom would deploy to Ebola-affected countries. All respondents cited scientific advancement as their chief motivation for participation, while 100/103 (97% and 61/103 (59% reported additional "humanitarian reasons" and potential protection from Ebolavirus, respectively. Although investigators had documented adverse events in 97% of trial participants, only 74 of 103 respondents (72% recalled experiencing an adverse event. All reported an overall positive experience, and 93/103 (90% a willingness to participate in future trials. Given the high level of satisfaction, no significant associations could be detected between trial experiences and satisfaction, even among respondents reporting adverse events lasting weeks or months. Despite considerable reactogenicity and unexpected vaccine-related arthritis, all survey respondents reported overall satisfaction. While this trial's context was unique, the positive feedback is likely due at least in part to the

  15. Barriers and facilitators for clinical trial participation among diverse Asian patients with breast cancer: a qualitative study.

    Science.gov (United States)

    Lee, Guek Eng; Ow, Mandy; Lie, Desiree; Dent, Rebecca

    2016-07-22

    Recruitment rates for cancer trials are low for racial/ethnic minorities. Little is known about factors influencing trial recruitment in Asian patients. Our aim is to examine the barriers and facilitators for participation in trials among multi-ethnic Asian women with breast cancer. We recruited a convenience sample from consecutive women seen at the National Cancer Centre. Two experienced bilingual (English and Chinese) moderators conducted focus groups to theme saturation. The question guide incorporated open-ended questions soliciting opinions about trial participation and knowledge. Women were first asked if they were willing, unwilling, or still open to participate in future trials. Sessions were audiotaped and transcribed. Transcripts were independently coded for emergent themes. Sixteen of 103 women approached participated in five focus groups. Chinese, Malay, and Indian participants aged 29 to 69 represented different cancer stages. Five had no prior knowledge of trials. We identified three major themes comprising of 22 minor themes for barriers and facilitators. The major themes were: 1) patient-related, 2) trial-related, and 3) sociocultural factors. Women willing to join trials expressed themes representing facilitators (better test therapy, cost-effective profile, or trust in doctors and local healthcare systems). Women unwilling to participate expressed themes associated with barriers, while women still open to participation expressed themes representing both facilitators and barriers. Malay women were more likely to express themes related to 'fatalism' as a barrier. We found that facilitators and barriers to trial participation among Asian women were similar to those previously reported in Western women. Knowledge of trials is limited among women receiving breast cancer treatment. Unique sociocultural factors suggest that approaches customised to local and community beliefs are needed to improve trial participation in minority groups.

  16. Informing potential participants about research: observational study with an embedded randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Helen M Kirkby

    Full Text Available OBJECTIVES: To assess: 1 the feasibility of electronic information provision; 2 gather evidence on the topics and level of detail of information potential research participant's accessed; 3 to assess satisfaction and understanding. DESIGN: Observational study with an embedded randomised controlled trial. SETTING: Low risk intervention study based in primary care. PARTICIPANTS: White British & Irish, South Asian and African-Caribbean subjects aged between 40-74 years eligible for a blood pressure monitoring study. INTERVENTIONS: PDF copy of the standard paper participant information sheet (PDF-PIS and an electronic Interactive Information Sheet (IIS where participants could choose both the type and level of detail accessed. MAIN OUTCOME MEASURES: 1 Proportion of participants providing an email address and accessing electronic information 2 Willingness to participate in a recruitment clinic. 3 Type and depth of information accessed on the IIS. 4 Participant satisfaction and understanding. RESULTS: 1160 participants were eligible for the study. Of these, 276 (24% provided an active email address, of whom 84 did not respond to the email. 106 responded to the email but chose not to access any electronic information and were therefore ineligible for randomisation. 42 were randomised to receive the PDF-PIS and 44 to receive the IIS (with consent rates of 48% and 36%, respectively; odds ratio 0.6, 95% confidence interval 0.25 to 1.4. Electronic observation of information accessed by potential participants showed 41% chose to access no information and only 9% accessed the detail presented on the Research Ethics Committee approved participant information sheet before booking to attend a recruitment clinic for the intervention study. 63 of the 106 participants (59% who chose not to access any electronic information also booked an appointment. CONCLUSIONS: Current written information about research may not be read, emphasising the importance of the consent

  17. Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

    Science.gov (United States)

    Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W

    2017-04-01

    Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. Clinical data from Progesterone for the Treatment of Traumatic Brain Injury

  18. [Motivation of patients to participate in clinical trials. An explorative survey].

    Science.gov (United States)

    Gaul, Charly; Malcherczyk, Annett; Schmidt, Thomas; Helm, Jürgen; Haerting, Johannes

    2010-02-01

    Difficulties in recruiting patients for clinical trials lead to increasing costs, and prolonged implementation of evidences into medical practice. Knowledge about motivation and barriers in potential participants would be helpful to develop successful recruitment strategies. Currently, no systematic research of determining factors affecting the decision to participate in clinical studies is available from German samples. After been given details about a potential participation in a clinical or diagnostic study in nine study centers, patients were recruited for an additional structured questionnaire survey concerning motivation and barriers to participation. 62 patients were included into the survey. 95.1% did not have any experience with clinical studies before. 66.1% met the physician explaining the study and asking for informed consent for the first time. Despite this, 96.6% judged the physician to be competent. Family and friends were important for decision-making about the participation in a study. Gender was only of marginal influence. The majority of patients (91.4%) expected advantages of the study for their own. 88% of the patients denominated potential advantages for other patients as an additional motivator. The possibility of adverse events was inferior for patients in decision-making about participation in a clinical trial. Physicians recruiting patients for clinical studies should be well prepared about details of the study and should have adequate time for an introductory conversation in a quiet environment. Including relatives into the introductory conversation may enhance the motivation and therefore the success of recruitment. Potential advantages of a participation for the own treatment and additionally for other patients should be highlighted. Possible side effects should be explained in a realistic manner.

  19. Is one trial enough for repeated testing? Same-day assessments of walking, mobility and fine hand use in people with myotonic dystrophy type 1.

    Science.gov (United States)

    Kierkegaard, Marie; Petitclerc, Emilie; Hébert, Luc J; Gagnon, Cynthia

    2017-02-01

    Performance-based assessments of physical function are essential in people with myotonic dystrophy type 1 (DM1) to monitor disease progression and evaluate interventions. Commonly used are the six-minute walk test, the 10 m-walk test, the timed up-and-go test, the timed-stands test, grip strength tests and the nine-hole peg test. The number of trials needed on a same-day test occasion and whether the first, best or average of trials should be reported as result is unknown. Thus, the aim was to describe and explore differences between trials in these measures of walking, mobility and fine hand use in 70 adults with DM1. Three trials were performed for each test except for the six-minute walk test where two trials were allowed. There were statistical significant differences over trials in all tests except for the 10 m-walk test and grip strength tests. Pair-wise comparisons showed that the second and third trials were in general better than the first, although effect sizes were small. At which trial the individuals performed their best differed between individuals and tests. People with severe muscular impairment had difficulties to perform repeated trials. Intraclass correlation coefficients were all high in analyses exploring how to report results. The conclusion and clinical implication is that, for a same-day test occasion, one trial is sufficient for the 10 m-walk test and grip strength tests, and that repeated trials should be allowed in the timed up-and-go test, timed-stands test and nine-hole peg tests. We recommend that two trials are performed for these latter tests as such a protocol could accommodate people with various levels of impairments and physical limitations. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Race/Ethnicity and the Pharmacogenetics of Reported Suicidality With Efavirenz Among Clinical Trials Participants.

    Science.gov (United States)

    Mollan, Katie R; Tierney, Camlin; Hellwege, Jacklyn N; Eron, Joseph J; Hudgens, Michael G; Gulick, Roy M; Haubrich, Richard; Sax, Paul E; Campbell, Thomas B; Daar, Eric S; Robertson, Kevin R; Ventura, Diana; Ma, Qing; Edwards, Digna R Velez; Haas, David W

    2017-09-01

    We examined associations between suicidality and genotypes that predict plasma efavirenz exposure among AIDS Clinical Trials Group study participants in the United States. Four clinical trials randomly assigned treatment-naive participants to efavirenz-containing regimens; suicidality was defined as reported suicidal ideation or attempted or completed suicide. Genotypes that predict plasma efavirenz exposure were defined by CYP2B6 and CYP2A6 polymorphisms. Associations were evaluated with weighted Cox proportional hazards models stratified by race/ethnicity. Additional analyses adjusted for genetic ancestry and selected covariates. Among 1833 participants, suicidality was documented in 41 in exposed analyses, and 34 in on-treatment analyses. In unadjusted analyses based on 12 genotype levels, suicidality increased per level in exposed (hazard ratio, 1.11; 95% confidence interval, .96-1.27) and on-treatment 1.16; 1.01-1.34) analyses. In the on-treatment analysis, the association was strongest among white but nearly null among black participants. Considering 3 metabolizer levels (extensive, intermediate and slow), slow metabolizers were at increased risk. Results were similar after baseline covariate-adjustment for genetic ancestry, sex, age, weight, injection drug use history, and psychiatric history or recent psychoactive medication. Genotypes that predict higher plasma efavirenz exposure were associated with increased risk of suicidality. Strength of association varied by race/ethnicity. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

  1. A booklet on participants' rights to improve consent for clinical research: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Jocelyne R Benatar

    Full Text Available OBJECTIVE: Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. METHODS: 21 currently used informed consent forms (ICF from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK. To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. RESULTS: Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs. 41 respectively, p = 0.0003. The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42. Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI 56 to 67 correct, or simplified ICF 62% (CI 58 to 68 correct compared to 52%, (CI 47 to 57 correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008. Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64

  2. A booklet on participants' rights to improve consent for clinical research: a randomized trial.

    Science.gov (United States)

    Benatar, Jocelyne R; Mortimer, John; Stretton, Matthew; Stewart, Ralph A H

    2012-01-01

    Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). A booklet

  3. Recruitment and reasons for non-participation in a family-coping-orientated palliative home care trial (FamCope)

    DEFF Research Database (Denmark)

    Ammari, ABH; Hendriksen, Carsten; Rydahl Hansen, Susan

    2015-01-01

    professionals. However, an unexpectedly high number of families declined participation in the trial. We describe and discuss the recruitment strategy and patient reported reasons for non-participation to add to the knowledge about what impedes recruitment and to identify the factors that influence willingness...... to participate in research aimed at family coping early in the palliative care trajectory. Patients with advanced cancer and their closest relative were recruited from medical, surgical, and oncological departments. Reasons for non-participation were registered and characteristics of participants and non......-participants were compared to evaluate differences between subgroups of non-participants based on reasons not to participate and reasons to participate in the trial. A total of 65.9% of the families declined participation. Two main categories for declining participation emerged: first, that the "burden of illness...

  4. Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey.

    Science.gov (United States)

    Brealey, Stephen; Andronis, Lazaros; Dennis, Laura; Atwell, Christine; Bryan, Stirling; Coulton, Simon; Cox, Helen; Cross, Ben; Fylan, Fiona; Garratt, Andrew; Gilbert, Fiona; Gillan, Maureen; Hendry, Maggie; Hood, Kerenza; Houston, Helen; King, David; Morton, Veronica; Robling, Michael; Russell, Ian; Wilkinson, Clare

    2010-12-01

    Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long) used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences. 553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference. Of the participants who returned the final follow-up questionnaire, 416 (88%) agreed to receive the results of the trial. Subsequently 132 (32%) participants responded to the survey. Most participants preferred the longer leaflet (55%) and the main reasons for this were the use of technical information (94%) and diagrams (89%). There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084). Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should be the focus of further research. The trial is registered

  5. Tolerability of the Oscar 2 ambulatory blood pressure monitor among research participants: a cross-sectional repeated measures study

    Directory of Open Access Journals (Sweden)

    Hinderliter Alan L

    2011-04-01

    Full Text Available Abstract Background Ambulatory blood pressure monitoring (ABPM is increasingly used to measure blood pressure (BP in research studies. We examined ease of use, comfort, degree of disturbance, reported adverse effects, factors associated with poor tolerability, and association of poor tolerability with data acquisition of 24-hour ABPM using the Oscar 2 monitor in the research setting. Methods Sixty adults participating in a research study of people with a history of borderline clinic BP reported on their experience with ABPM on two occasions one week apart. Poor tolerability was operationalized as an overall score at or above the 75th percentile using responses to questions adapted from a previously developed questionnaire. In addition to descriptive statistics (means for responses to Likert-scaled "0 to 10" questions and proportions for Yes/No questions, we examined reproducibility of poor tolerability as well as associations with poor tolerability and whether poor tolerability was associated with removal of the monitor or inadequate number of BP measurements. Results The mean ambulatory BP of participants by an initial ABPM session was 148/87 mm Hg. After wearing the monitor the first time, the degree to which the monitor was felt to be cumbersome ranged from a mean of 3.0 to 3.8, depending on whether at work, home, driving, or other times. The most bother was interference with normal sleeping pattern (mean 4.2. Wearers found the monitor straightforward to use (mean 7.5. Nearly 67% reported that the monitor woke them after falling asleep, and 8.6% removed it at some point during the night. Reported adverse effects included pain (32%, skin irritation (37%, and bruising (7%. Those categorized as having poor tolerability (kappa = 0.5 between sessions, p = 0.0003 were more likely to report being in fair/poor health (75% vs 22%, p = 0.01 and have elevated 24-hour BP average (systolic: 28% vs 17%, p = 0.56; diastolic: 30% vs 17%, p = 0.37. They were

  6. Women's views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study.

    Science.gov (United States)

    Sawyer, Alexandra; Chhoa, Celine; Ayers, Susan; Pushpa-Rajah, Angela; Duley, Lelia

    2017-09-09

    The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. In addition to standard written consent, an oral assent pathway was developed for use when birth was imminent. The aim of this study was to explore women's views and experiences of two alternative consent pathways to participate in the Cord Pilot Trial. We conducted a qualitative study using semi-structured interviews. A total of 179 participants in the Cord Pilot Trial were sent a postal invitation to take part in interviews. Women who agreed were interviewed in person or by telephone to explore their experiences of two consent pathways for a preterm intrapartum trial. Data were analysed using inductive systematic thematic analysis. Twenty-three women who gave either written consent (n = 18) or oral assent followed by written consent (n = 5) to participate in the trial were interviewed. Five themes were identified: (1) understanding of the implications of randomisation, (2) importance of staff offering participation, (3) information about the trial and time to consider participation, (4) trial secondary in women's minds and (5) reasons for agreeing to take part in the trial. Experiences were similar for the two consent pathways. Women recruited by the oral assent pathway reported being given less information about the trial but felt it was sufficient to make a decision regarding participation. There were gaps in women's understanding of the trial and intervention, regardless of the consent pathway. Overall, women were positive about their experiences of being invited to participate in the trial. The oral assent pathway seems an acceptable option for women if the intervention is low-risk and time is limited. ISRCTN Registry, ISRCTN21456601 . Registered on 28 February 2013.

  7. Trial of labor compared to repeat cesarean section in women with no other risk factors than a prior cesarean delivery

    DEFF Research Database (Denmark)

    Studsgaard, Anne; Skorstengaard, Malene; Glavind, Julie

    2013-01-01

    OBJECTIVE: To compare outcomes with trial of labor after cesarean (TOLAC) or elective repeat cesarean delivery on maternal request (ERCD-MR). DESIGN: Prospective cohort study. SETTING: Danish university hospital. POPULATION: Women with TOLAC (n = 1161) and women with ERCD-MR (n = 622) between 2003...... registration of the deliveries. MAIN OUTCOME MEASURES: Adverse neonatal outcomes, risk factors for emergency cesarean, and uterine rupture in case of TOLAC. RESULTS: TOLAC was associated with an increased risk of neonatal depression [odds ratio (OR) 3.6, 95% confidence interval (CI) 1.1-19.1] and neonatal...... vaginal delivery (adjusted OR 1.8, 95% CI 1.1-3.0), index emergency cesarean during labor (adjusted OR 3.0, 95% CI 2.3-4.1), maternal age ≥35 years (adjusted OR 1.9, 95% CI 1.3-2.8), pre-pregnancy body mass index ≥30 (adjusted OR 2.1, 95% CI 1.3-3.3), and birthweight 4000-4499 g (adjusted OR 1.5, 95% CI 1...

  8. Brief Report: Using the Internet to Identify Persons with Cognitive Impairment for Participation in Clinical Trials

    Directory of Open Access Journals (Sweden)

    Lindsay F. Morra

    2017-04-01

    Full Text Available Identifying, recruiting, and enrolling persons in clinical trials of dementia treatments is extremely difficult. One approach to first-wave screening of potential participants is the use of online assessment tools. Initial studies using the Dementia Risk Assessment (DRA—which includes a previously validated recognition memory test—support the use of this self-administered assessment to identify individuals with “suspected MCI” or “suspected dementia.” In this study, we identified between 71 and 622 persons with suspected dementia and between 128 and 1653 persons with suspected mild cognitive impairment (depending on specific criteria over the course of 22 months. Assessment tools that can inexpensively and easily identify individuals with higher than average risk for cognitive impairment can facilitate recruitment for large-scale clinical trials for dementia treatments.

  9. Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial.

    Science.gov (United States)

    Akello, Carolyne A; Bunge, Katherine E; Nakabiito, Clemensia; Mirembe, Brenda G; Fowler, Mary Glenn; Mishra, Anupam; Marrazzo, Jeanne; Chirenje, Zvavahera M; Celum, Connie; Balkus, Jennifer E

    2017-06-01

    Recent HIV prevention trials required use of effective contraceptive methods to fulfill eligibility for enrollment. We compared pregnancy rates in a subset of participants enrolled in the Microbicide Trials Network protocol (MTN-003), a randomized trial of chemoprophylaxis to prevent HIV acquisition among women aged 18-45 years who initiated depot medroxyprogesterone acetate (DMPA) or combined oral contraceptives (COCs) at enrollment, relative to those already using DMPA or COCs. Data were analyzed from MTN-003 participants from Uganda. Before enrollment, information on contraceptive type and initiation date was obtained. Urine pregnancy tests were performed at monthly follow-up visits. Cox proportional hazards models were used to compare pregnancy incidence among new users (initiated ≤60 days before enrollment) and established users (initiated >60 days before enrollment). Of 322 women enrolled, 296 were COC or DMPA users, 82 (28%) were new users, and 214 (72%) were established users. Pregnancy incidence was higher among new contraceptive users compared to established users (20.70% vs. 10.55%; adjusted hazard ratio [HR] = 1.66; 95% confidence interval [95% CI] 0.93-2.96). Among DMPA users, pregnancy incidence was 10.20% in new users versus 3.48% in established users (HR = 2.56; 95% CI 0.86-7.65). Among new COC users, pregnancy incidence was 42.67% in new users versus 23.67% in established COC users (adjusted HR = 1.74; 95% CI 0.87-3.48). New contraceptive users, regardless of method, at the Uganda MTN-003 site had an increased pregnancy risk compared to established users, which may be due to contraceptive initiation primarily for trial eligibility. New users may benefit from intensive contraceptive counseling and additional contraceptive options, including longer acting reversible contraceptives.

  10. A multimedia consent tool for research participants in the Gambia: a randomized controlled trial.

    Science.gov (United States)

    Afolabi, Muhammed Olanrewaju; McGrath, Nuala; D'Alessandro, Umberto; Kampmann, Beate; Imoukhuede, Egeruan B; Ravinetto, Raffaella M; Alexander, Neal; Larson, Heidi J; Chandramohan, Daniel; Bojang, Kalifa

    2015-05-01

    To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia. Adults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants' comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups. On day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P = 0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12-0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13-0.82). There was no significant independent association with educational level. The risk that a participant's comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16-0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand. A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy.

  11. Knowledge, Attitudes, and Experiences of HIV Pre-Exposure Prophylaxis (PrEP) Trial Participants in Botswana.

    Science.gov (United States)

    Toledo, Lauren; McLellan-Lemal, Eleanor; Henderson, Faith L; Kebaabetswe, Poloko M

    2015-03-01

    Recent clinical trials have shown that a daily dose of oral TDF/FTC pre-exposure prophylaxis (PrEP) is effective in reducing human immunodeficiency (HIV) risk. Understanding trial participants' perspectives about retention and PrEP adherence is critical to inform future PrEP trials and the scale-up and implementation of PrEP programs. We analyzed 53 in-depth interviews conducted in April 2010 with participants in the TDF2 study, a Phase 3, randomized, double-blind, placebo-controlled clinical trial of daily oral TDF/FTC with heterosexual men and women in Francistown and Gaborone, Botswana. We examined participants' knowledge, attitudes, and experiences of the trial, identified facilitators and barriers to enrollment and retention, and compared participant responses by study site, sex, and study drug adherence. Our findings point to several factors to consider for participant retention and adherence in PrEP trials and programs, including conducting pre-enrollment education and myth reduction counseling, providing accurate estimates of participant obligations and side effect symptoms, ensuring participant understanding of the effects of non-adherence, gauging personal commitment and interest in study outcomes, and developing a strong external social support network for participants.

  12. Who participates in a randomized trial of mindfulness-based stress reduction (MBSR) after breast cancer?

    DEFF Research Database (Denmark)

    Würtzen, Hanne; Oksbjerg Dalton, Susanne; Kaae Andersen, Klaus

    2013-01-01

    Danish population-based registries and clinical databases to determine differences in demographics, breast cancer and co-morbidity among 1208 women eligible for a randomized controlled trial (www.clinicaltrials.gov identifier: NCT00990977) of mindfulness-based stress reduction MBSR. RESULTS: Participants......BACKGROUND: Discussion regarding the necessity to identify patients with both the need and motivation for psychosocial intervention is ongoing. Evidence for an effect of mindfulness-based interventions among cancer patients is based on few studies with no systematic enrollment. METHODS: We used...

  13. Using Mechanical Turk to recruit participants for internet intervention research: experience from recruitment for four trials targeting hazardous alcohol consumption.

    Science.gov (United States)

    Cunningham, John A; Godinho, Alexandra; Kushnir, Vladyslav

    2017-12-01

    Mechanical Turk (MTurk) is an online portal operated by Amazon where 'requesters' (individuals or businesses) can submit jobs for 'workers.' MTurk is used extensively by academics as a quick and cheap means of collecting questionnaire data, including information on alcohol consumption, from a diverse sample of participants. We tested the feasibility of recruiting for alcohol Internet intervention trials through MTurk. Participants, 18 years or older, who drank at least weekly were recruited for four intervention trials (combined sample size, N = 11,107). The same basic recruitment strategy was employed for each trial - invite participants to complete a survey about alcohol consumption (less than 15 min in length, US$1.50 payment), identify eligible participants who drank in a hazardous fashion, invite those eligible to complete a follow-up survey ($10 payment), randomize participants to be sent or not sent information to access an online intervention for hazardous alcohol use. Procedures where put in place to optimize the chances that participants could only complete the baseline survey once. There was a substantially slower rate of recruitment by the fourth trial compared to the earlier trials. Demographic characteristics also varied across trials (age, sex, employment and marital status). Patterns of alcohol consumption, while displaying some differences, did not appear to vary in a linear fashion between trials. It is possible to recruit large (but not inexhaustible) numbers of people who drink in a hazardous fashion. Issues for online intervention research when employing this sample are discussed.

  14. Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials.

    Science.gov (United States)

    Ott, Mary A; Crawley, Francis P; Sáez-Llorens, Xavier; Owusu-Agyei, Seth; Neubauer, David; Dubin, Gary; Poplazarova, Tatjana; Begg, Norman; Rosenthal, Susan L

    2018-06-01

    Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12-14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.

  15. Pregnancy and contraceptive use among women participating in the FEM-PrEP trial.

    Science.gov (United States)

    Callahan, Rebecca; Nanda, Kavita; Kapiga, Saidi; Malahleha, Mookho; Mandala, Justin; Ogada, Teresa; Van Damme, Lut; Taylor, Douglas

    2015-02-01

    Pregnancy among study participants remains a challenge for trials of new HIV prevention agents despite promotion and provision of contraception. We evaluated contraceptive use, pregnancy incidence, and study drug adherence by contraceptive method among women enrolled in the FEM-PrEP trial of once-daily oral tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) for HIV prevention. We required women to be using effective non-barrier contraception at enrollment. At each monthly follow-up visit, women were counseled on contraceptive use and tested for pregnancy. TDF-FTC adherence was determined by measuring plasma drug concentrations at 4-week intervals. We used Cox proportional hazards models to assess factors associated with incident pregnancy and multivariate logistic regression to examine the relationship between contraceptive method used at enrollment and TDF-FTC adherence. More than half of women were not using effective contraception before enrollment. Ninety-eight percent of these women adopted either injectable (55%) or oral (43%) contraceptives. The overall pregnancy rate was 9.6 per 100 woman-years. Among injectable users and new users of combined oral contraceptives (COCs), the rates were 1.6 and 35.1, respectively. New users of injectables had significantly greater odds of adhering to TDF-FTC than new COC users [odds ratio (95% confidence interval): 4.4 (1.7 to 11.6), P = 0.002], existing COC users [3.1 (1.3 to 7.3), P = 0.01], and existing injectable users [2.4 (1.1 to 5.6), P = 0.04]. Women using COCs during FEM-PrEP, particularly new adopters, were more likely to become pregnant and less likely to adhere to study product than injectable users. HIV prevention trials should consider requiring long-acting methods, including injectables, for study participation.

  16. Extensive but not Limited Repeated Trials in Passive Avoidance Task Induce Stress-like Symptoms and Affect Memory Function in Rats.

    Science.gov (United States)

    Tabassum, Saiqa; Haider, Saida

    2018-02-10

    Stressful and emotionally arousing experiences are remembered, and previous reports show that repeated exposure to stressful condition enhances emotional learning. However, the usefulness of the repeated exposure depends on the intensity and duration. Although repeated training as a strategy to improve memory performance is receiving increased attention from researchers, repeated training may induce stressful effects that have not yet been considered. The present study investigated whether exposure to repetitive learning trials with limited or extensive durations in a passive avoidance task (PAT) would be beneficial or harmful to emotional memory performance in rats. Rats were exposed to repetitive learning trials for two different durations in the limited exposure (exposure to four repetitive trials) and extensive exposure groups (exposure to 16 repetitive trials) in a single day to compare the impact of both conditions on rat emotional memory performance. Alterations in corticosterone content and associated oxidative and neurochemical systems were assessed to explore the underlying mechanism responsible for changes in emotional memory. Following extensive exposure, a negative impact on emotional memory was observed compared with the limited exposure group. A lack of any further improvement in memory function following extensive training exposure was supported by increased corticosterone levels, decreased 5-hydroxytryptamine (5-HT) levels and abnormal oxidative stress levels, which may induce negative effects on memory consolidation. It is suggested that limited exposure to repetitive learning trials is more useful for studying improvement in emotional memory, whereas extensive exposure may produce chronic stress-like condition that can be detrimental and responsible for compromised memory performance. Copyright © 2017 IBRO. Published by Elsevier Ltd. All rights reserved.

  17. Treatment Assignment Guesses by Study Participants in a Double-Blind Dose Escalation Clinical Trial of Saw Palmetto

    OpenAIRE

    Lee, Jeannette Y.; Moore, Page; Kusek, John; Barry, Michael

    2014-01-01

    Objectives: This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM).

  18. Korean Cancer Patients' Awareness of Clinical Trials, Perceptions on the Benefit and Willingness to Participate.

    Science.gov (United States)

    Lim, Yoojoo; Lim, Jee Min; Jeong, Won Jae; Lee, Kyung-Hun; Keam, Bhumsuk; Kim, Tae-Yong; Kim, Tae Min; Han, Sae-Won; Oh, Do Youn; Kim, Dong-Wan; Kim, Tae-You; Heo, Dae Seog; Bang, Yung-Jue; Im, Seock-Ah

    2017-10-01

    The purpose of this study was to assess current levels of awareness of clinical trials (CTs), perceptions regarding their benefits and willingness to participate to CTs among Korean cancer patients. From December 2012 to August 2015, we distributed questionnaires to cancer patients receiving systemic anti-cancer therapy at Seoul National University Hospital, Seoul, Korea. A total of 397 out of 520 requested patients (76.3%) responded to the survey. Among the 397 patients, 62.5% were female and the median age was 52 years. Overall, 97.4% (387/397) answered that they have at least heard of CTs. When asked about their level of awareness, 23.8% (92/387) answered that they could more than roughly explain about CTs. The average visual analogue scale score of CT benefit in all patients was 6.43 (standard deviation, 2.20). Patients who were only familiar with the term without detailed knowledge of the contents had the least expectation of benefit from CTs (p=0.015). When asked about their willingness to participate in CTs, 56.7% (225/397) answered positively. Patients with higher levels of awareness of CTs showed higher willingness to participate (p awareness regarding CTs was positively related to the positive perception and willingness to participate. Although the general awareness of CTs was high, a relatively large proportion of patients did not have accurate knowledge; therefore, proper and accurate patient education is necessary.

  19. Korean Cancer Patients’ Awareness of Clinical Trials, Perceptions on the Benefit and Willingness to Participate

    Science.gov (United States)

    Lim, Yoojoo; Lim, Jee Min; Jeong, Won Jae; Lee, Kyung-Hun; Keam, Bhumsuk; Kim, Tae-Yong; Kim, Tae Min; Han, Sae-Won; Oh, Do Youn; Kim, Dong-Wan; Kim, Tae-You; Heo, Dae Seog; Bang, Yung-Jue; Im, Seock-Ah

    2017-01-01

    Purpose The purpose of this study was to assess current levels of awareness of clinical trials (CTs), perceptions regarding their benefits and willingness to participate to CTs among Korean cancer patients. Materials and Methods From December 2012 to August 2015, we distributed questionnaires to cancer patients receiving systemic anti-cancer therapy at Seoul National University Hospital, Seoul, Korea. Results A total of 397 out of 520 requested patients (76.3%) responded to the survey. Among the 397 patients, 62.5% were female and the median age was 52 years. Overall, 97.4% (387/397) answered that they have at least heard of CTs. When asked about their level of awareness, 23.8% (92/387) answered that they could more than roughly explain about CTs. The average visual analogue scale score of CT benefit in all patients was 6.43 (standard deviation, 2.20). Patients who were only familiar with the term without detailed knowledge of the contents had the least expectation of benefit from CTs (p=0.015). When asked about their willingness to participate in CTs, 56.7% (225/397) answered positively. Patients with higher levels of awareness of CTs showed higher willingness to participate (p awareness regarding CTs was positively related to the positive perception and willingness to participate. Although the general awareness of CTs was high, a relatively large proportion of patients did not have accurate knowledge; therefore, proper and accurate patient education is necessary. PMID:28392549

  20. Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: A randomized controlled trial.

    Science.gov (United States)

    Blikman, Lyan Jm; van Meeteren, Jetty; Twisk, Jos Wr; de Laat, Fred Aj; de Groot, Vincent; Beckerman, Heleen; Stam, Henk J; Bussmann, Johannes Bj

    2017-10-01

    Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS). To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue. A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength - CIS20r) and participation (Impact on Participation and Autonomy scale - IPA). Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = -0.81; 95% confidence interval (CI), -3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35). The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition.

  1. Two controlled trials to increase participant retention in a randomized controlled trial of mobile phone-based smoking cessation support in the United Kingdom.

    Science.gov (United States)

    Severi, Ettore; Free, Caroline; Knight, Rosemary; Robertson, Steven; Edwards, Philip; Hoile, Elizabeth

    2011-10-01

    Loss to follow-up of trial participants represents a threat to research validity. To date, interventions designed to increase participants' awareness of benefits to society of completing follow-up, and the impact of a telephone call from a senior female clinician and researcher requesting follow-up have not been evaluated robustly. Trial 1 aimed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society. Trial 2 aimed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and researcher. Two single-blind randomized controlled trials were nested within a larger trial, Txt2stop. In Trial 1, participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up, or to a control group receiving a simple reminder regarding follow-up. In Trial 2, participants were randomly allocated to receive a telephone call from a senior female clinician and researcher, or to a control group receiving standard Txt2stop follow-up procedures. Trial 1: 33.5% (327 of 976) of the intervention group and 33.8% (329 of 974) of the control group returned the questionnaire within 26 weeks of randomization, risk ratio (RR) 0.99; 95% confidence interval (CI) 0.88-1.12. In all, 83.3% (813 of 976) of the intervention group and 82.2% (801 of/974) of the control group sent back the questionnaire within 30 weeks of randomization, RR 1.01; 95% CI 0.97, 1.05. Trial 2: 31% (20 of 65) of the intervention group and 32% (20 of 62) of the control group completed trial follow-up, RR 0.93; 95%CI 0.44, 1.98. In presence of other methods to increase follow-up neither experimental method (refrigerator magnet and text message emphasizing participation's benefits to society nor a telephone call from study's principal investigator) increased participant follow-up in the Txt2stop trial.

  2. Employment and paid work among participants in a randomized controlled trial comparing diacetylmorphine and hydromorphone.

    Science.gov (United States)

    Nikoo, Mohammadali; Vogel, Marc; Choi, Fiona; Song, Michael J; Burghardt, Jensen; Zafari, Zafar; Tabi, Katarina; Frank, Anastasia; Barbic, Skye; Schütz, Christian; Jang, Kerry; Krausz, Michael

    2018-04-12

    Employment is one of the less studied but a significant outcome of medication-assisted treatment. Thus, we aimed to explore employment outcomes of medication-assisted treatment with hydromorphone (HDM) or diacetylmorphine (DAM). The secondary aim was to estimate characteristics of this population as well as treatment-related factors associated with these outcomes. This was a secondary analysis of a randomized, double blind controlled trial. A total of 102 and 100 participants were randomized to receive injectable DAM or HDM for 6 months respectively. In stage 2, 144 participants were randomized again to receive either oral or injectable forms of the medication they received for another 6 months. Participants were interviewed at 5 timepoints: before and 3, 6, 9 and 12 months after treatment assignment. Generalized estimating equations (GEE) with a logit link was fitted to determine factors related to paid work in the past 30 days. Mean age of participants was 44.3 (SD = 9.6) and 59 (29.2%) participants were men. At each timepoint, 6-8 (3.6%-4.1%) participants reported employment in the past 30 days and 40 to 52 (19.7%-26.7%) reported minimum 1 day of paid work. University or college education [OR = 2.12: 95% CI = (1.25, 3.62), P = 0.01] was significantly associated with paid work after adjustment for age, gender, treatment arms, timepoints, days receiving study treatment, physical health, psychological health and crack cocaine use in the past 30 days. The rate of employment was lower among participants of this study compared to similar studies on heroin-assisted treatment. Higher education was associated with increased odds of paid work. A large gap exists between employment rate and the proportion of participants who reported paid work. Supported employment and occupational therapy could optimize the employment outcomes of this population. Copyright © 2018 Elsevier B.V. All rights reserved.

  3. Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey

    Directory of Open Access Journals (Sweden)

    Houston Helen

    2010-12-01

    Full Text Available Abstract Background Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences. Methods 553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference. Results Of the participants who returned the final follow-up questionnaire, 416 (88% agreed to receive the results of the trial. Subsequently 132 (32% participants responded to the survey. Most participants preferred the longer leaflet (55% and the main reasons for this were the use of technical information (94% and diagrams (89%. There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084. Conclusions Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should

  4. Innovating information-delivery for potential clinical trials participants. What do patients want from multi-media resources?

    Science.gov (United States)

    Shneerson, Catherine; Windle, Richard; Cox, Karen

    2013-01-01

    To discover whether the provision of clinical trials information via a multi-media platform could better meet the needs, preferences and practices of potential cancer trial participants. A mixed qualitative and quantitative questionnaire was delivered to 72 participants from cancer support groups to elicit views on the provision and design features of multimedia resources in delivering clinical trials information. Perceived lack of information is an expressed barrier to clinical trials participation. Multimedia resources were viewed positively as a way to address this barrier by most potential clinical trials participants; in particular by helping to align information to individual needs, promote active engagement with information, and by allowing more control of the learning experience. Whilst text remained the most valued attribute of any resource, other highly rated attributes included the resource being simple to use, easily accessible, having a clear focus, incorporating examples and visual aids, and being interactive. Provision of support for the learning resource was also rated highly. As in other areas, such as education, multimedia resources may enhance the delivery and acceptance of information regarding clinical trials. Better alignment of information may have a positive impact on recruitment and retention into clinical trials. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  5. Does message framing predict willingness to participate in a hypothetical HIV vaccine trial: an application of Prospect Theory.

    Science.gov (United States)

    Evangeli, Michael; Kafaar, Zuhayr; Kagee, Ashraf; Swartz, Leslie; Bullemor-Day, Philippa

    2013-01-01

    It is vital that enough participants are willing to participate in clinical trials to test HIV vaccines adequately. It is, therefore, necessary to explore what affects peoples' willingness to participate (WTP) in such trials. Studies have only examined individual factors associated with WTP and not the effect of messages about trial participation on potential participants (e.g., whether losses or gains are emphasized, or whether the outcome is certain or uncertain). This study explores whether the effects of message framing on WTP in a hypothetical HIV vaccine trial are consistent with Prospect Theory. This theory suggests that people are fundamentally risk averse and that (1) under conditions of low risk and high certainty, gain-framed messages will be influential (2) under conditions of high risk and low certainty, loss-framed messages will be influential. This cross-sectional study recruited 283 HIV-negative students from a South African university who were given a questionnaire that contained matched certain gain-framed, certain loss-framed, uncertain gain-framed, and uncertain loss-framed statements based on common barriers and facilitators of WTP. Participants were asked to rate how likely each statement was to result in their participation in a hypothetical preventative HIV vaccine trial. Consistent with Prospect Theory predictions, for certain outcomes, gain-framed messages were more likely to result in WTP than loss-framed messages. Inconsistent with predictions, loss-framed message were not more likely to be related to WTP for uncertain outcomes than gain-framed messages. Older students were less likely to express their WTP across the different message frames. Recruitment for HIV vaccine trials should pay attention to how messages about the trial are presented to potential participants.

  6. Rationale and design of REACT: a randomised controlled trial assessing the effectiveness of home-collection to increase chlamydia retesting and detect repeat positive tests

    OpenAIRE

    Smith, Kirsty S; Hocking, Jane S; Chen, Marcus; Fairley, Christopher K; McNulty, Anna; Read, Phillip; Bradshaw, Catriona S; Tabrizi, Sepehr N; Wand, Handan; Saville, Marion; Rawlinson, William; Garland, Suzanne M; Donovan, Basil; Kaldor, John M; Guy, Rebecca

    2014-01-01

    Background Repeat infection with Chlamydia trachomatis is common and increases the risk of sequelae in women and HIV seroconversion in men who have sex with men (MSM). Despite guidelines recommending chlamydia retesting three months after treatment, retesting rates are low. We are conducting the first randomised controlled trial to assess the effectiveness of home collection combined with short message service (SMS) reminders on chlamydia retesting and reinfection rates in three risk groups. ...

  7. ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke

    DEFF Research Database (Denmark)

    Boysen, Gudrun; Krarup, Lars-Henrik; Zeng, Xianrong

    2009-01-01

    To investigate if repeated verbal instructions about physical activity to patients with ischaemic stroke could increase long term physical activity.......To investigate if repeated verbal instructions about physical activity to patients with ischaemic stroke could increase long term physical activity....

  8. Characteristic adverse events and their incidence among patients participating in acute ischemic stroke trials.

    Science.gov (United States)

    Hesse, Kerrick; Fulton, Rachael L; Abdul-Rahim, Azmil H; Lees, Kennedy R

    2014-09-01

    Adverse events (AE) in trial populations present a major burden to researchers and patients, yet most events are unrelated to investigational treatment. We aimed to develop a coherent list of expected AEs, whose incidence can be predicted by patient characteristics that will inform future trials and perhaps general poststroke care. We analyzed raw AE data from patients participating in acute ischemic stroke trials. We identified events that occurred with a lower 99% confidence bound greater than nil. Among these, we applied receiver operating characteristic principles to select the fewest types of events that together represented the greatest number of reports. Using ordinal logistic regression, we modeled the incidence of these events as a function of patient age, sex, baseline National Institutes of Health Stroke Scale, and multimorbidity status, defining Ppatients, reporting 21 217 AEs. Among 756 types of AEs, 132 accounted for 82.7%, of which 80% began within 10 days after stroke. Right hemisphere (odds ratio [OR], 1.67), increasing baseline National Institutes of Health Stroke Scale (OR, 1.11), multimorbidity status (OR, 1.09 per disease), patient age (OR, 1.01 per year), height (OR, 1.01 per centimeter), diastolic blood pressure (OR, 0.99 per mm Hg), and smoking (OR, 0.82) were independently associated with developing more AEs but together explained only 13% of the variation. A list of 132 expected AEs after acute ischemic stroke may be used to simplify interpretation and reporting of complications. AEs can be modestly predicted by patient characteristics, facilitating stratification of patients by risk for poststroke complications. © 2014 American Heart Association, Inc.

  9. Classification of processes involved in sharing individual participant data from clinical trials.

    Science.gov (United States)

    Ohmann, Christian; Canham, Steve; Banzi, Rita; Kuchinke, Wolfgang; Battaglia, Serena

    2018-01-01

    Background: In recent years, a cultural change in the handling of data from research has resulted in the strong promotion of a culture of openness and increased sharing of data. In the area of clinical trials, sharing of individual participant data involves a complex set of processes and the interaction of many actors and actions. Individual services/tools to support data sharing are available, but what is missing is a detailed, structured and comprehensive list of processes/subprocesses involved and tools/services needed. Methods : Principles and recommendations from a published data sharing consensus document are analysed in detail by a small expert group. Processes/subprocesses involved in data sharing are identified and linked to actors and possible services/tools. Definitions are adapted from the business process model and notation (BPMN) and applied in the analysis. Results: A detailed and comprehensive list of individual processes/subprocesses involved in data sharing, structured according to 9 main processes, is provided. Possible tools/services to support these processes/subprocesses are identified and grouped according to major type of support. Conclusions: The list of individual processes/subprocesses and tools/services identified is a first step towards development of a generic framework or architecture for sharing of data from clinical trials. Such a framework is strongly needed to give an overview of how various actors, research processes and services could form an interoperable system for data sharing.

  10. Why do patients choose (not) to participate in an exercise trial during adjuvant chemotherapy for breast cancer?

    NARCIS (Netherlands)

    van Waart, H.; van Harten, W.H.; Buffart, L.M.; Sonke, G.S.; Stuiver, M.M.; Aaronson, N.K.

    2016-01-01

    Objective: Only between 25% and 50% of patients invited to participate in clinical trial-based physical exercise programs during cancer treatment agree to do so. The purpose of this study was to identify factors associated significantly with the decision (not) to participate in a randomized

  11. Why do patients choose (not) to participate in an exercise trial during adjuvant chemotherapy for breast cancer?

    NARCIS (Netherlands)

    van Waart, Hanna; van Harten, Willem H.; Buffart, Laurien M.; Sonke, Gabe S.; Stuiver, Martijn M.; Aaronson, Neil K.

    2015-01-01

    Objective Only between 25% and 50% of patients invited to participate in clinical trial-based physical exercise programs during cancer treatment agree to do so. The purpose of this study was to identify factors associated significantly with the decision (not) to participate in a randomized

  12. Using Mechanical Turk to recruit participants for internet intervention research: experience from recruitment for four trials targeting hazardous alcohol consumption

    Directory of Open Access Journals (Sweden)

    John A. Cunningham

    2017-12-01

    Full Text Available Abstract Background Mechanical Turk (MTurk is an online portal operated by Amazon where ‘requesters’ (individuals or businesses can submit jobs for ‘workers.’ MTurk is used extensively by academics as a quick and cheap means of collecting questionnaire data, including information on alcohol consumption, from a diverse sample of participants. We tested the feasibility of recruiting for alcohol Internet intervention trials through MTurk. Methods Participants, 18 years or older, who drank at least weekly were recruited for four intervention trials (combined sample size, N = 11,107. The same basic recruitment strategy was employed for each trial – invite participants to complete a survey about alcohol consumption (less than 15 min in length, US$1.50 payment, identify eligible participants who drank in a hazardous fashion, invite those eligible to complete a follow-up survey ($10 payment, randomize participants to be sent or not sent information to access an online intervention for hazardous alcohol use. Procedures where put in place to optimize the chances that participants could only complete the baseline survey once. Results There was a substantially slower rate of recruitment by the fourth trial compared to the earlier trials. Demographic characteristics also varied across trials (age, sex, employment and marital status. Patterns of alcohol consumption, while displaying some differences, did not appear to vary in a linear fashion between trials. Conclusions It is possible to recruit large (but not inexhaustible numbers of people who drink in a hazardous fashion. Issues for online intervention research when employing this sample are discussed.

  13. Provision of intrauterine contraception in association with first trimester induced abortion reduces the need of repeat abortion: first-year results of a randomized controlled trial.

    Science.gov (United States)

    Pohjoranta, Elina; Mentula, Maarit; Gissler, Mika; Suhonen, Satu; Heikinheimo, Oskari

    2015-11-01

    Can the need of subsequent abortion be reduced by providing intrauterine contraception as a part of the abortion service? Provision of intrauterine devices (IUDs) in association with first trimester abortion more than halved the incidence of repeat abortion during the first year of follow-up. Following abortion, the incidence of subsequent abortion is high, up to 30-40%. In cohort studies, intrauterine contraception has reduced the need of repeat abortion by 60-70%. A randomized controlled trial. The main outcome measure was the incidence of subsequent induced abortions during the follow-up. Altogether 751 women seeking first trimester induced abortion were recruited and randomized into two groups. Randomization was accomplished by computer-assisted permuted-block randomization with random block sizes of four to six. The investigators did not participate in randomization, which was done before commencing the study. The participants were recruited between 18 October 2010 and 21 January 2013. The inclusion criteria were age ≥18 years, duration of pregnancy ≤12 weeks, accepting intrauterine contraception, residence in Helsinki and signing the informed consent form. Women with contraindications to intrauterine contraception, such as uterine anomaly, acute genital infection or pap-smear change requiring surgical treatment were ineligible to participate.This study was conducted in collaboration between the Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, and Centralized family planning of the City of Helsinki.The intervention group (n = 375) was provided with intrauterine contraception (either the levonorgestrel-releasing intrauterine system or copper-releasing intrauterine device) immediately following surgical abortion (18.1%) or at a follow-up 2-4 weeks after medical abortion (81.9%). Women in the control group were prescribed oral contraceptives and advised to contact their primary healthcare unit for a follow

  14. Motivations to participate in a Phase I/II HIV vaccine trial: A descriptive study from Dar es Salaam, Tanzania

    Directory of Open Access Journals (Sweden)

    E. A. M. Tarimo

    2016-02-01

    Full Text Available Abstract Background The search for an efficacious HIV vaccine is a global priority. To date only one HIV vaccine trial (RV144 has shown modest efficacy in a phase III trial. With existing different HIV-1 subtypes and frequent mutations, multiple trials are needed from different geographical sites particularly in sub-Saharan Africa where most HIV infections occur. Thus, motivations to participate in HIV vaccine trials among Tanzanians need to be assessed. This paper describes the motives of Police Officers who showed great interest to volunteer in HIVIS-03 in Dar es Salaam, Tanzania. Methods A descriptive cross-sectional study was conducted among Police Officers who showed interest to participate in the HIVIS-03, a phase I/II HIV vaccine trial in Dar es Salaam. Prior to detailed training sessions about HIV vaccine trials, the potential participants narrated their individual motives to participate in the trial on a piece of paper. Descriptive analysis using content approach and frequency distributions were performed. Results Of the 265 respondents, 242 (91.3 % provided their socio-demographic characteristics as well as reasons that would make them take part in the proposed trial. Majority, (39.7 %, cited altruism as the main motive. Women were more likely to volunteer due to altruism compared to men (P < 0.01. Researchers’ explanations about HIV/AIDS vaccine studies motivated 15.3 %. More men (19.6 % than women (1.7 % were motivated to volunteer due to researchers’ explanations (P < 0.001. Also, compared to other groups, those unmarried and educated up to secondary level of education were motivated to volunteer due to researchers’ explanation (P < 0.05. Other reasons were: desire to become a role model (18.6 %; to get knowledge for educating others (14.0 %; to cooperate with researchers in developing an HIV vaccine (9.5 %; to get protection against HIV infection (7.0 %, and severity of the disease within families (6.2

  15. A screening tool to enhance clinical trial participation at a community center involved in a radiation oncology disparities program.

    Science.gov (United States)

    Proctor, Julian W; Martz, Elaine; Schenken, Larry L; Rainville, Rebecca; Marlowe, Ursula

    2011-05-01

    To investigate the effectiveness of a screening tool to enhance clinical trial participation at a community radiation oncology center involved in a National Cancer Institute-funded disparities program but lacking on-site clinical trials personnel. The screening form was pasted to the front of the charts and filled out for all new patients over the 9-month period of the study, during which time five external beam radiation therapy (EBRT) trials and a patient perception study were open for accrual. Patient consent was obtained by assorted personnel at several different sites. Patients potentially eligible for a trial were identified and approached by one of the clinic staff. Patients who were under- or uninsured, age > 80 years, members of an racial/ethnic minority, or recipients of medical assistance were identified as at risk for health care disparities and were offered patient navigator services. Of 196 patients consulted during the study, 144 were treated with EBRT. Of the 24 patients eligible for EBRT trials, 23 were approached (one had an incomplete screening form), and 15 accepted. Of 77 patients eligible for a patient perception trial, 72 were approached (five had incomplete forms), and 45 accepted. The eligibility and acceptance rates for EBRT trials were similar for disparities and nondisparities patients. Screening was completed for 96 patients (67%). When completed, the screening tool ensured clinical trial accrual. The major factor limiting overall accrual was a shortage of available trials.

  16. Repeated Remote Ischemic Conditioning Effect on Ankle-brachial Index in Diabetic Patients - A Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Najmeh Shahvazian

    2017-01-01

    Full Text Available Background: Remote ischemic preconditioning (RIPC is a phenomenon where a short period of ischemia in one organ protects against further ischemia in the other organs. We hypothesized that RIPC occurring in diabetic patients with ankle brachial index (ABI between 0.70 and 0.90 were included with peripheral arterial disease, would make the better coronary flow resulted in the increasing ABI. Materials and Methods: This randomized clinical trial study was done in the Afshar Cardiovascular Hospital in Yazd between 2013 and 2014. Sixty participants were randomly divided into two groups (intervention and control groups. The intervention group was undergoing RIPC, and the control group was tested without RIPC. RIPC was stimulated by giving three cycles of 5 min of ischemia followed by 5 min of reperfusion of both upper arms using a blood pressure cuff inflated to 200 mm Hg (n = 30. This was compared with no RIPC group which consisted of placing a deflated blood pressure cuff on the upper limbs (n = 30. Results: The mean of ABI level before intervention in the RIPC and control group group was 0.82 ± 0.055 and 0.83 ± 0.0603 (P = 0.347 respectively, with no significant difference. It was 0.86 ± 0.066 in the RIPC group compared the control 0.83 ± 0.0603 (P = 0.046. So levels of ABI were greater after intervention in the RIPC group. The mean of ABI level increase from 0.82 ± 0.05 to 0.86 ± 0.06 in RIPC group (P = 0.008. So the intervention group showed a significant increase in ABI. Conclusions: RIPC through using a simple, noninvasive technique, composing three cycles of 5 min-ischemia of both upper arms, showing a significant increase in ABI level in diabetic patients.

  17. Repeatability and response to therapy of dynamic contrast-enhanced magnetic resonance imaging biomarkers in rheumatoid arthritis in a large multicentre trial setting

    Energy Technology Data Exchange (ETDEWEB)

    Waterton, John C. [University of Manchester, Stopford Building, Manchester Academic Health Sciences Centre, Manchester (United Kingdom); Personalised Healthcare and Biomarkers, AstraZeneca, Macclesfield (United Kingdom); Ho, Meilien [AstraZeneca, Global Medicines Development, Macclesfield (United Kingdom); Nordenmark, Lars H. [AstraZeneca, Global Medicines Development, Moelndal (Sweden); Jenkins, Martin [AstraZeneca, Global Medicines Development, Cambridge (United Kingdom); DiCarlo, Julie; Peterfy, Charles [Spire Sciences Inc, Boca Raton, FL (United States); Guillard, Gwenael; Bowes, Michael A. [Imorphics, Manchester (United Kingdom); Roberts, Caleb; Buonaccorsi, Giovanni [Bioxydyn, Manchester (United Kingdom); Parker, Geoffrey J.M. [University of Manchester, Stopford Building, Manchester Academic Health Sciences Centre, Manchester (United Kingdom); Bioxydyn, Manchester (United Kingdom); Kellner, Herbert [Private Practice and Division of Rheumatology KHI Neuwittelsbach, Muenchen (Germany); Taylor, Peter C. [University of Oxford, Kennedy Institute, Oxford (United Kingdom)

    2017-09-15

    To determine the repeatability and response to therapy of dynamic contrast-enhanced (DCE) MRI biomarkers of synovitis in the hand and wrist of rheumatoid arthritis (RA) patients, and in particular the performance of the transfer constant K{sup trans}, in a multicentre trial setting. DCE-MRI and RA MRI scoring (RAMRIS) were performed with meticulous standardisation at baseline and 6 and 24 weeks in a substudy of fostamatinib monotherapy in reducing synovitis compared with placebo or adalimumab. Analysis employed statistical shape modelling to avoid biased regions-of-interest, kinetic modelling and heuristic analyses. Repeatability was also evaluated. At early study termination, DCE-MRI data had been acquired from 58 patients in 19 imaging centres. K{sup trans} intra-subject coefficient of variation (N = 14) was 30%. K{sup trans} change demonstrated inferiority of fostamatinib (N = 11) relative to adalimumab (N = 10) after 6 weeks (treatment ratio = 1.92, p = 0.003), and failed to distinguish fostamatinib from placebo (N = 10, p = 0.79). RAMRIS showed superiority of fostamatinib relative to placebo at 6 weeks (p = 0.023), and did not distinguish fostamatinib from adalimumab at either 6 (p = 0.175) or 24 (p = 0.230) weeks. This demonstrated repeatability of K{sup trans} and its ability to distinguish treatment groups show that DCE-MRI biomarkers are suitable for use in multicentre RA trials. (orig.)

  18. Factors associated with non-participation and dropout among cancer patients in a cluster-randomised controlled trial.

    Science.gov (United States)

    Roick, J; Danker, H; Kersting, A; Briest, S; Dietrich, A; Dietz, A; Einenkel, J; Papsdorf, K; Lordick, F; Meixensberger, J; Mössner, J; Niederwieser, D; Prietzel, T; Schiefke, F; Stolzenburg, J-U; Wirtz, H; Singer, S

    2018-01-01

    We investigated the impact of demographic and disease related factors on non-participation and dropout in a cluster-randomised behavioural trial in cancer patients with measurements taken between hospitalisation and 6 months thereafter. The percentages of non-participation and dropout were documented at each time point. Factors considered to be potentially related with non-participation and dropout were as follows: age, sex, marital status, education, income, employment status, tumour site and stage of disease. Of 1,338 eligible patients, 24% declined participation at baseline. Non-participation was higher in older patients (Odds Ratio [OR] 2.1, CI: 0.6-0.9) and those with advanced disease (OR 2.0, CI: 0.1-1.3). Dropout by 6 months was 25%. Dropout was more frequent with increased age (OR 2.8, CI: 0.8-1.2), advanced disease (OR 3.0, CI: 1.0-1.2), being married (OR 2.4, CI 0.7-1.1) and less frequent with university education (OR 0.4, CI -1.3 to -0.8) and middle income (OR 0.4, CI -0.9 to -0.7). When planning clinical trials, it is important to be aware of patient groups at high risk of non-participation or dropout, for example older patients or those with advanced disease. Trial designs should consider their special needs to increase their rate of participation. © 2017 John Wiley & Sons Ltd.

  19. Associations of obesogenic behaviors in mothers and obese children participating in a randomized trial.

    Science.gov (United States)

    Sonneville, Kendrin R; Rifas-Shiman, Sheryl L; Kleinman, Ken P; Gortmaker, Steven L; Gillman, Matthew W; Taveras, Elsie M

    2012-07-01

    Relatively little research has assessed the association between obesogenic behaviors in parents and their children. The objective of the present analysis was to examine cross-sectional associations in television (TV)/video viewing, sugar-sweetened beverage intake, and fast food intake between mothers and their preschool aged children. We studied baseline data among 428 participants in High Five for Kids, a randomized controlled trial of behavior change among overweight and obese children of ages 2-6.9 years. The main exposures were whether mothers viewed TV/videos beverages, and ate fast food food beverages (73%), while few mothers viewed food goal (68%), but not the goals for sugar-sweetened beverages (31%) or TV/video viewing (13%). In adjusted models, the odds ratios for a child meeting the goal were 3.2 (95% confidence interval (CI) 1.7, 6.2) for TV/video viewing, 5.8 (95% CI 2.8, 12.0) for sugar-sweetened beverage intake, and 17.5 (95% CI 9.8, 31.2) for fast food intake if their mothers met the goal for the same behavior. Obesogenic behaviors of mothers and preschool aged children were strongly associated. Our findings lend support to obesity prevention strategies that target parental behavior and the family environment.

  20. Assessing a cognitive music training for older participants: a randomised controlled trial.

    Science.gov (United States)

    Biasutti, Michele; Mangiacotti, Anthony

    2018-02-01

    In a randomised controlled trial, we investigated whether a cognitive training based on rhythm-music and music improvisation exercises had positive effects on executive functions in older participants. Thirty-five residents in a guest home with mild-moderate cognitive impairment and healthy ageing were randomly assigned to an experimental group (n = 18) featuring cognitive music training composed of 12 bi-weekly 70-min sessions, and a control group (n = 17) attended 12 bi-weekly 45-min sessions of gymnastic activities offered by the institute. A neuropsychological test battery was administered at baseline and at the end of treatment, including the Mini-Mental State Examination, verbal fluency test, Trail Making Test A, attentional matrices test and clock-drawing test. Pre-test and post-test comparison showed a significant improvement for the experimental group reflected in the Mini-Mental State Examination (F(1,33) = 13.906; p music-rhythmic exercises and music improvisation exercises is associated with improved cognitive functions in older people with mild-moderate cognitive impairment regardless of the individual's degree of cognitive reserve. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  1. Dataset for Phase I randomized clinical trial for safety and tolerability of GET 73 in single and repeated ascending doses including preliminary pharmacokinetic parameters

    Directory of Open Access Journals (Sweden)

    Carolina L. Haass-Koffler

    2017-12-01

    Full Text Available The data in this article outline the methods used for the administration of GET 73 in the first time-in-human manuscript entitled “Phase I randomized clinical trial for the safety, tolerability and preliminary pharmacokinetics of the mGluR5 negative allosteric modulator GET 73 following single and repeated doses in healthy male volunteers” (Haass-Koffler et al., 2017 [1]. Data sets are provided in two different manners. The first series of tables provided includes procedural information about the experiments conducted. The next series of tables provided includes Pharmacokinetic (PK parameters for GET 73 and its main metabolite MET 2. This set of data is comprised by two experiments: Experiment 1 references a single ascending dose administration of GET 73 and Experiment 2 references a repeated ascending dose administration of GET 73. Keywords: Glutamate receptor subtype 5 (mGlu5, Allosteric modulator, GET 73, Safety, Tolerability

  2. Dataset for Phase I randomized clinical trial for safety and tolerability of GET 73 in single and repeated ascending doses including preliminary pharmacokinetic parameters.

    Science.gov (United States)

    Haass-Koffler, Carolina L; Goodyear, Kimberly; Long, Victoria M; Tran, Harrison H; Loche, Antonella; Cacciaglia, Roberto; Swift, Robert M; Leggio, Lorenzo

    2017-12-01

    The data in this article outline the methods used for the administration of GET 73 in the first time-in-human manuscript entitled "Phase I randomized clinical trial for the safety, tolerability and preliminary pharmacokinetics of the mGluR5 negative allosteric modulator GET 73 following single and repeated doses in healthy male volunteers" (Haass-Koffler et al., 2017) [1]. Data sets are provided in two different manners. The first series of tables provided includes procedural information about the experiments conducted. The next series of tables provided includes Pharmacokinetic (PK) parameters for GET 73 and its main metabolite MET 2. This set of data is comprised by two experiments: Experiment 1 references a single ascending dose administration of GET 73 and Experiment 2 references a repeated ascending dose administration of GET 73.

  3. Biomarker pattern of ARIA-E participants in phase 3 randomized clinical trials with bapineuzumab.

    Science.gov (United States)

    Liu, Enchi; Wang, Dai; Sperling, Reisa; Salloway, Stephen; Fox, Nick C; Blennow, Kaj; Scheltens, Philip; Schmidt, Mark E; Streffer, Johannes; Novak, Gerald; Einstein, Steve; Booth, Kevin; Ketter, Nzeera; Brashear, H Robert

    2018-03-06

    To evaluate whether amyloid-related imaging abnormalities with edema/effusion (ARIA-E) observed in bapineuzumab clinical trials was associated with specific biomarker patterns. Bapineuzumab, an anti-β-amyloid monoclonal antibody, was evaluated in patients with mild to moderate Alzheimer disease. Amyloid PET imaging, CSF biomarkers, or volumetric MRI (vMRI) were assessed. A total of 1,512 participants underwent one or more biomarker assessments; 154 developed incident ARIA-E. No differences were observed at baseline between ARIA-E and non-ARIA-E participants in brain amyloid burden by PET, the majority of vMRI measures, or CSF biomarkers, with the exception of lower baseline CSF Aβ 42 in APOE ε4 noncarrier ARIA-E vs non-ARIA-E groups (bapineuzumab non-ARIA-E p = 0.027; placebo non-ARIA-E p = 0.012). At week 71, bapineuzumab-treated participants with ARIA-E vs non-ARIA-E showed greater reduction in brain amyloid PET, greater reductions in CSF phosphorylated tau (p-tau) (all comparisons p < 0.01), and total tau (t-tau) (all comparisons p < 0.025), and greater hippocampal volume reduction and ventricular enlargement (all p < 0.05). Greater reduction in CSF Aβ 40 concentrations was observed for ARIA-E versus both non-ARIA-E groups (bapineuzumab/placebo non-ARIA-E p = 0.015/0.049). No group differences were observed at week 71 for changes in whole brain volume or CSF Aβ 42 . Baseline biomarkers largely do not predict risk for developing ARIA-E. ARIA-E was associated with significant longitudinal changes in several biomarkers, with larger reductions in amyloid PET and CSF p-tau and t-tau concentrations, and paradoxically greater hippocampal volume reduction and ventricular enlargement, suggesting that ARIA-E in bapineuzumab-treated cases may be related to increased Aβ efflux from the brain and affecting downstream pathogenic processes. © 2018 American Academy of Neurology.

  4. Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence

    Science.gov (United States)

    McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C

    2016-01-01

    Background Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people’s early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. Objective The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. Methods In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. Results The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated

  5. Exploring barriers and facilitators to participation of male-to-female transgender persons in preventive HIV vaccine clinical trials.

    Science.gov (United States)

    Andrasik, Michele Peake; Yoon, Ro; Mooney, Jessica; Broder, Gail; Bolton, Marcus; Votto, Teress; Davis-Vogel, Annet

    2014-06-01

    Observed seroincidence and prevalence rates in male-to-female (MTF) transgender individuals highlight the need for effective targeted HIV prevention strategies for this community. In order to develop an effective vaccine that can be used by transgender women, researchers must understand and address existing structural issues that present barriers to this group's participation in HIV vaccine clinical trials. Overcoming barriers to participation is important for ensuring HIV vaccine acceptability and efficacy for the MTF transgender community. To explore barriers and facilitators to MTF transgender participation in preventive HIV vaccine clinical trials, the HIV Vaccine Trials Network conducted focus groups among transgender women in four urban areas (Atlanta, Boston, Philadelphia, and San Francisco). Barriers and facilitators to engagement of transgender women in preventive HIV vaccine clinical trials led to the following recommendations: (a) transgender cultural competency training, (b) creating trans-friendly environments, (c) true partnerships with local trans-friendly organizations and health care providers, (d) protocols that focus on transgender specific issues, and (e) data collection and tracking of transgender individuals. These results have implications for the conduct of HIV vaccine trials, as well as engagement of transgender women in research programs in general.

  6. Recruiting participants with peripheral arterial disease for clinical trials: experience from the Study to Improve Leg Circulation (SILC).

    Science.gov (United States)

    McDermott, Mary M; Domanchuk, Kathryn; Dyer, Alan; Ades, Philip; Kibbe, Melina; Criqui, Michael H

    2009-03-01

    To describe the success of diverse recruitment methods in a randomized controlled clinical trial of exercise in persons with peripheral arterial disease (PAD). An analysis of recruitment sources conducted for the 746 men and women completing a baseline visit for the study to improve leg circulation (SILC), a randomized controlled trial of exercise for patients with PAD. For each recruitment source, we determined the number of randomized participants, the rate of randomization among those completing a baseline visit, and cost per randomized participant. Of the 746 individuals who completed a baseline visit, 156 were eligible and randomized. The most frequent sources of randomized participants were newspaper advertising (n = 67), mailed recruitment letters to patients with PAD identified at the study medical center (n = 25), and radio advertising (n = 18). Costs per randomized participant were $2750 for television advertising, $2167 for Life Line Screening, $2369 for newspaper advertising, $3931 for mailed postcards to older community dwelling men and women, and $5691 for radio advertising. Among those completing a baseline visit, randomization rates ranged from 10% for those identified from radio advertising to 32% for those identified from the Chicago Veterans Administration and 33% for those identified from posted flyers. Most participants in a randomized controlled trial of exercise were recruited from newspaper advertising and mailed recruitment letters to patients with known PAD. The highest randomization rates after a baseline visit occurred among participants identified from posted flyers and mailed recruitment letters to PAD patients.

  7. Why Providers Participate in Clinical Trials: Considering the National Cancer Institute’s Community Clinical Oncology Program

    Science.gov (United States)

    McAlearney, Ann Scheck; Song, Paula H.; Reiter, Kristin L.

    2012-01-01

    Background The translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute’s Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP participation involves unsubsidized costs and organizational challenges that raise concerns about sustained provider participation in clinical trials. Objectives This study was designed to improve our understanding of why providers participate in the CCOP in order to inform the decision-making process of administrators, clinicians, organizations, and policy-makers considering CCOP participation. Research Methods We conducted a multi-site qualitative study of five provider organizations engaged with the CCOP. We interviewed 41 administrative and clinician key informants, asking about what motivated CCOP participation, and what benefits they associated with involvement. We deductively and inductively analyzed verbatim interview transcripts, and explored themes that emerged. Results Interviewees expressed both “altruistic” and “self-interested” motives for CCOP participation. Altruistic reasons included a desire to increase access to clinical trials and feeling an obligation to patients. Self-interested reasons included the desire to enhance reputation, and a need to integrate disparate cancer care activities. Perceived benefits largely matched expressed motives for CCOP participation, and included internal and external benefits to the organization, and quality of care benefits for both patients and participating physicians. Conclusion The motives and benefits providers attributed to CCOP participation are consistent with translational research goals, offering evidence that participation can contribute value to providers by expanding access to innovative medical care for patients in need. PMID:22925970

  8. Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence.

    Science.gov (United States)

    Koziol-McLain, Jane; McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C

    2016-10-25

    Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people's early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated, and randomized), 412 (82.2%) were

  9. Comparison of mailed invitation strategies to improve fecal occult blood test participation in men: protocol for a randomized controlled trial.

    Science.gov (United States)

    Duncan, Amy; Zajac, Ian; Flight, Ingrid; Stewart, Benjamin J R; Wilson, Carlene; Turnbull, Deborah

    2013-07-31

    Men have a significantly increased risk of being diagnosed with, and dying from, colorectal cancer (CRC) than women. Men also participate in fecal occult blood test (FOBT) screening at a lower rate than women. This study will determine whether strategies that target men's attitudes toward screening, and matched to stage of readiness to screen, increase men's FOBT participation compared to a standard approach. Eligible trial participants will be a national sample of 9,200 men aged 50 to 74 years, living in urban Australia and randomly selected from the Australian electoral roll. Trial participants will be mailed an advance notification letter, followed 2 weeks later by an invitation letter and a free fecal immunochemical test (FIT) kit. The intervention is a factorial design, randomized controlled trial (RCT) with four trial arms, including a control. The content of the advance notification and invitation letters will differ by trial arm as follows: 1) standard advance notification and standard invitation (control arm); 2) targeted advance notification and standard invitation; 3) standard advance notification and targeted invitation; and 4) targeted advance notification and targeted invitation. The standard letters will replicate as closely as possible the letters included in the Australian National Bowel Cancer Screening Program (NBCSP). Modified advance notification and invitation letters will incorporate additional messages to target men in the precontemplation (advance notification) and contemplation stages (invitation). The primary outcome is return of the completed FIT within 12 weeks of invitation. Analysts will be blinded to trial assignment and participants will be blinded to the use of varying invitational materials. Subsamples from each trial arm will complete baseline and endpoint surveys to measure the psychological impact of the intervention, and qualitative interviews will be conducted to evaluate attitudes toward the intervention. The outcomes of

  10. Feasibility and acceptability of conducting HIV vaccine trials in adolescents in South Africa: Going beyond willingness to participate towards implementation

    Directory of Open Access Journals (Sweden)

    M Wallace

    2018-03-01

    Full Text Available Background. HIV/AIDS remains a leading cause of death in adolescents (aged 15 - 25 years, and in sub-Saharan Africa HIV-related deaths continue to rise in this age group despite a decline in both adult and paediatric populations. This is attributable in part to high adolescent infection rates and supports the urgent need for more efficacious prevention strategies. In particular, an even partially effective HIV vaccine, given prior to sexual debut, is predicted to significantly curb adolescent infection rates. While adolescents have indicated willingness to participate in HIV vaccine trials, there are concerns around safety, uptake, adherence, and ethical and logistic issues.Objectives. To initiate a national, multisite project with the aim of identifying obstacles to conducting adolescent HIV vaccine trials in South Africa (SA.Method. A simulated HIV vaccine trial was conducted in adolescents aged 12 - 17 years across five SA research sites, using the already licensed Merck human papillomavirus vaccine Gardasil as a proxy for an HIV vaccine. Adolescents were recruited at community venues and, following a vaccine discussion group, invited to participate in the trial. Consent for trial enrolment was obtained from a parent or legal guardian, and participants aged 16 - 17 years were eligible only if sexually active. Typical vaccine trial procedures were applied during the five study visits, including the administration of vaccination injections at study visits 2, 3 and 4.Results. The median age of participants was 14 years (interquartile range 13 - 15, with 81% between the ages of 12 and 15 years at enrolment. Overall, 98% of screened participants opted to receive the vaccine, 588 participants enrolled, and 524 (89% attended the final visit.Conclusions. This trial showed that adolescents can be recruited, enrolled and retained in clinical prevention trials with parental support. While promising, these results were tempered by the coupling of sexual

  11. Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis

    OpenAIRE

    Carter, Anouska; Humphreys, Liam; Snowdon, Nicky; Sharrack, Basil; Daley, Amanda; Petty, Jane; Woodroofe, Nicola; Saxton, John

    2015-01-01

    Background The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Despite an increase in research into the benefits of exercise in people with multiple sclerosis (PwMS), no trial has reported detailed data on effective recruitment strategies for large-scale randomised controlled trials. The main purpose of this report is to provide a detailed outline of recruitment strategies, rates and estimated costs in the Exercise Intervent...

  12. Altruistic reasoning in adolescent-parent dyads considering participation in a hypothetical sexual health clinical trial for adolescents.

    Science.gov (United States)

    Chávez, Noé Rubén; Williams, Camille Y; Ipp, Lisa S; Catallozzi, Marina; Rosenthal, Susan L; Breitkopf, Carmen Radecki

    2016-04-01

    Altruism is a well-established reason underlying research participation. Less is known about altruism in adolescent-parent decision-making about clinical trials enrolling healthy adolescents. This qualitative investigation focused on identifying spontaneous statements of altruism within adolescent-parent (dyadic) discussions of participation in a hypothetical phase I clinical trial related to adolescent sexual health. Content analysis revealed several response patterns to each other's altruistic reasoning. Across 70 adolescent-parent dyads in which adolescents were 14-17 years of age and 91% of their parents were mothers, a majority (61%) of dyadic discussions included a statement reflecting altruism. Parents responded to adolescents' statements of altruism more frequently than adolescents responded to parents' statements. Responses included: expresses concern, reiterates altruistic reasoning, agrees with altruistic reasoning, and adds to/expands altruistic reasoning. Since an altruistic perspective was often balanced with concerns about risk or study procedures, researchers cannot assume that altruism will directly lead to study participation. Optimizing the informed consent process for early phase clinical trials involving healthy adolescents may include supporting parents to have conversations with their adolescents which will enhance their capacity to consider all aspects of trial participation.

  13. A nudge toward participation: Improving clinical trial enrollment with behavioral economics.

    Science.gov (United States)

    VanEpps, Eric M; Volpp, Kevin G; Halpern, Scott D

    2016-07-20

    Interventions informed by behavioral economics can address barriers to patient enrollment in clinical trials and improve recruitment efforts. Copyright © 2016, American Association for the Advancement of Science.

  14. Test-Retest Variability of Functional and Structural Parameters in Patients with Stargardt Disease Participating in the SAR422459 Gene Therapy Trial.

    Science.gov (United States)

    Parker, Maria A; Choi, Dongseok; Erker, Laura R; Pennesi, Mark E; Yang, Paul; Chegarnov, Elvira N; Steinkamp, Peter N; Schlechter, Catherine L; Dhaenens, Claire-Marie; Mohand-Said, Saddek; Audo, Isabelle; Sahel, Jose; Weleber, Richard G; Wilson, David J

    2016-10-01

    The goal of this analysis was to determine the test-retest variability of functional and structural measures from a cohort of patients with advanced forms of Stargardt Disease (STGD) participating in the SAR422459 (NCT01367444) gene therapy clinical trial. Twenty-two participants, aged 24 to 66, diagnosed with advanced forms of STGD, with at least one pathogenic ABCA4 mutation on each chromosome participating in the SAR422459 (NCT01367444) gene therapy clinical trial, were screened over three visits within 3 weeks or less. Functional visual evaluations included: best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, semiautomated kinetic perimetry (SKP) using isopters I4e, III4e, and V4e, hill of vision (HOV) calculated from static visual fields (SVF) by using a 184n point centrally condensed grid with the stimulus size V test target. Retinal structural changes such as central macular thickness and macular volume were assessed by spectral-domain optical coherence tomography (SD-OCT). Repeatability coefficients (RC) and 95% confidential intervals (CI) were calculated for each parameter using a hierarchical mixed-effects model and bootstrapping. Criteria for statistically significant changes for various parameters were found to be the following: BCVA letter score (8 letters), SKP isopters I4e, III4e, and V4e (3478.85; 2488.02 and 2622.46 deg 2 , respectively), SVF full volume HOV (V TOT, 14.62 dB-sr), central macular thickness, and macular volume (4.27 μm and 0.15 mm 3 , respectively). This analysis provides important information necessary to determine if significant changes are occurring in structural and functional assessments commonly used to measure disease progression in this cohort of patients with STGD. Moreover, this information is useful for future trials assessing safety and efficacy of treatments in STGD. Determination of variability of functional and structural measures in participants with advanced stages of

  15. Test–Retest Variability of Functional and Structural Parameters in Patients with Stargardt Disease Participating in the SAR422459 Gene Therapy Trial

    Science.gov (United States)

    Parker, Maria A.; Choi, Dongseok; Erker, Laura R.; Pennesi, Mark E.; Yang, Paul; Chegarnov, Elvira N.; Steinkamp, Peter N.; Schlechter, Catherine L.; Dhaenens, Claire-Marie; Mohand-Said, Saddek; Audo, Isabelle; Sahel, Jose; Weleber, Richard G.; Wilson, David J.

    2016-01-01

    Purpose The goal of this analysis was to determine the test–retest variability of functional and structural measures from a cohort of patients with advanced forms of Stargardt Disease (STGD) participating in the SAR422459 (NCT01367444) gene therapy clinical trial. Methods Twenty-two participants, aged 24 to 66, diagnosed with advanced forms of STGD, with at least one pathogenic ABCA4 mutation on each chromosome participating in the SAR422459 (NCT01367444) gene therapy clinical trial, were screened over three visits within 3 weeks or less. Functional visual evaluations included: best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, semiautomated kinetic perimetry (SKP) using isopters I4e, III4e, and V4e, hill of vision (HOV) calculated from static visual fields (SVF) by using a 184n point centrally condensed grid with the stimulus size V test target. Retinal structural changes such as central macular thickness and macular volume were assessed by spectral-domain optical coherence tomography (SD-OCT). Repeatability coefficients (RC) and 95% confidential intervals (CI) were calculated for each parameter using a hierarchical mixed-effects model and bootstrapping. Results Criteria for statistically significant changes for various parameters were found to be the following: BCVA letter score (8 letters), SKP isopters I4e, III4e, and V4e (3478.85; 2488.02 and 2622.46 deg2, respectively), SVF full volume HOV (VTOT, 14.62 dB-sr), central macular thickness, and macular volume (4.27 μm and 0.15 mm3, respectively). Conclusions This analysis provides important information necessary to determine if significant changes are occurring in structural and functional assessments commonly used to measure disease progression in this cohort of patients with STGD. Moreover, this information is useful for future trials assessing safety and efficacy of treatments in STGD. Translational Relevance Determination of variability of functional and

  16. A comparison of the baseline metabolic profiles between Diabetes Prevention Trial-Type 1 and TrialNet Natural History Study participants.

    Science.gov (United States)

    Sosenko, Jay M; Mahon, Jeffrey; Rafkin, Lisa; Lachin, John M; Krause-Steinrauf, Heidi; Krischer, Jeffrey P; Cuthbertson, David; Palmer, Jerry P; Thompson, Clinton; Greenbaum, Carla J; Skyler, Jay S

    2011-03-01

    We assessed whether differing autoantibody screening criteria for type 1 diabetes (T1D) prevention trials result in different baseline metabolic profiles of those who screen positive. Diabetes Prevention Trial-Type 1 (DPT-1) participants were screened for islet cell autoantibodies, whereas TrialNet Natural History Study (TNNHS) participants were screened for biochemical autoantibodies. In both studies, those determined to be autoantibody positive underwent baseline oral glucose tolerance tests (OGTTs) in which glucose and C-peptide were measured. The percentage of those with an OGTT in the diabetic range was higher among the DPT-1 participants (10.0% of 956 vs. 6.4% of 645, p < 0.01). In a logistic regression analysis with adjustments for age and gender, the difference persisted (p < 0.01). Among those in the non-diabetic range (n = 860 for DPT-1 and n = 604 for the TNNHS), glucose levels were similar at all time points, except for higher fasting glucose levels in the TNNHS participants (p < 0.001). There was a higher percentage of impaired fasting glucose (IFG) in the TNNHS participants (10.9 vs. 6.7%, p < 0.01); however, with adjustments for age and gender, there was no longer a significant difference. There was no significant difference in the percentages with impaired glucose tolerance. C-peptide levels were much lower in the DPT-1 cohort at all OGTT time points (p < 0.001 for all). Differing criteria for autoantibody screening can result in marked differences in the baseline metabolic profiles of prospective participants of T1D prevention trials. © 2010 John Wiley & Sons A/S.

  17. The Health Informatics Trial Enhancement Project (HITE: Using routinely collected primary care data to identify potential participants for a depression trial

    Directory of Open Access Journals (Sweden)

    Lyons Ronan A

    2010-04-01

    Full Text Available Abstract Background Recruitment to clinical trials can be challenging. We identified anonymous potential participants to an existing pragmatic randomised controlled depression trial to assess the feasibility of using routinely collected data to identify potential trial participants. We discuss the strengths and limitations of this approach, assess its potential value, report challenges and ethical issues encountered. Methods Swansea University's Health Information Research Unit's Secure Anonymised Information Linkage (SAIL database of routinely collected health records was interrogated, using Structured Query Language (SQL. Read codes were used to create an algorithm of inclusion/exclusion criteria with which to identify suitable anonymous participants. Two independent clinicians rated the eligibility of the potential participants' identified. Inter-rater reliability was assessed using the kappa statistic and inter-class correlation. Results The study population (N = 37263 comprised all adults registered at five general practices in Swansea UK. Using the algorithm 867 anonymous potential participants were identified. The sensitivity and specificity results > 0.9 suggested a high degree of accuracy from the algorithm. The inter-rater reliability results indicated strong agreement between the confirming raters. The Intra Class Correlation Coefficient (Cronbach's Alpha > 0.9, suggested excellent agreement and Kappa coefficient > 0.8; almost perfect agreement. Conclusions This proof of concept study showed that routinely collected primary care data can be used to identify potential participants for a pragmatic randomised controlled trial of folate augmentation of antidepressant therapy for the treatment of depression. Further work will be needed to assess generalisability to other conditions and settings and the inclusion of this approach to support Electronic Enhanced Recruitment (EER.

  18. Effects on leisure activities and social participation of a case management intervention for frail older people living at home: a randomised controlled trial.

    Science.gov (United States)

    Granbom, Marianne; Kristensson, Jimmie; Sandberg, Magnus

    2017-07-01

    Frailty causes disability and restrictions on older people's ability to engage in leisure activities and for social participation. The objective of this study was to evaluate the effects of a 1-year case management intervention for frail older people living at home in Sweden in terms of social participation and leisure activities. The study was a randomised controlled trial with repeated follow-ups. The sample (n = 153) was consecutively and randomly assigned to intervention (n = 80) or control groups (n = 73). The intervention group received monthly home visits over the course of a year by nurses and physiotherapists working as case managers, using a multifactorial preventive approach. Data collections on social participation, leisure activities and rating of important leisure activities were performed at baseline, 3, 6, 9 and 12 months, with recruitment between October 2006 and April 2011. The results did not show any differences in favour of the intervention on social participation. However, the intervention group performed leisure activities in general, and important physical leisure activities, to a greater extent than the control group at the 3-month follow-up (median 13 vs. 11, P = 0.034 and median 3 vs. 3, P = 0.031 respectively). A statistically significantly greater proportion of participants from the intervention group had an increased or unchanged number of important social leisure activities that they performed for the periods from baseline to 3 months (93.2% vs. 75.4%, OR = 4.48, 95% CI: 1.37-14.58). Even though statistically significant findings in favour of the intervention were found, more research on activity-focused case management interventions is needed to achieve clear effects on social participation and leisure activities. © 2017 John Wiley & Sons Ltd.

  19. Characteristics of cancer patients participating in presurgical lifestyle intervention trials exploring effects on tumor biology

    Directory of Open Access Journals (Sweden)

    John A. Dasher

    2017-12-01

    Conclusion: Similar to other clinical trials, lack of time is a leading barrier to enrollment, and travel/distance appears to be a greater barrier for women in presurgical studies. Larger presurgical lifestyle intervention trials will require tailored strategies to enhance recruitment.

  20. ParticipACTION: A mass media campaign targeting parents of inactive children; knowledge, saliency, and trialing behaviours

    Directory of Open Access Journals (Sweden)

    Gauvin Lise

    2009-12-01

    Full Text Available Abstract Background In late 2007, Canada's ParticipACTION national physical activity mass media campaign was re-launched, with an initial campaign targeting parents of elementary school-aged children. The campaign informed them about the risks of physical inactivity for children and youth. The purpose of this study was to assess campaign awareness and understanding following the campaign, and to identify whether exposure to this campaign was likely associated with behaviour change. Methods A convenience sample of 1,500 adults was recruited though an existing panel (n = 60,000 of Canadian adults to participate in online surveys. Initial campaign exposure included "prompted" and "unprompted" recall of specific physical activity messages from the 2007 ParticipACTION campaign, knowledge of the benefits of PA, saliency, and initial trial behaviours to help their children become more active. Results One quarter of respondents showed unprompted recall of specific message content from the ParticipACTION campaign, and prompted recall was 57%. Message recall and understanding was associated with knowledge about physical activity, and that in turn was related to high saliency. Saliency was associated with each of the physical activity-related trial behaviours asked. Conclusion Campaign awareness and understanding was high following this ParticipACTION campaign, and was associated with intermediate campaign outcomes, including saliency and trial behaviours. This is relevant to campaign evaluations, as it suggests that an initial focus on influencing awareness and understanding is likely to lead to more substantial change in campaign endpoints.

  1. Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

    Directory of Open Access Journals (Sweden)

    Soyeon Cheon

    2018-01-01

    Full Text Available Abstract Background While full disclosure of information on placebo control in participant information leaflets (PILs in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes. Methods Authors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model. Results In 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI −0.21 vs. −0.16; p = 0.38. In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference − 0.43 vs. −0.12; p = 0.03, probably due to enhanced expectations. Conclusions How participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we

  2. Decision-Making Process Related to Participation in Phase I Clinical Trials: A Nonsystematic Review of the Existing Evidence.

    Science.gov (United States)

    Gorini, Alessandra; Mazzocco, Ketti; Pravettoni, Gabriella

    2015-01-01

    Due to the lack of other treatment options, patient candidates for participation in phase I clinical trials are considered the most vulnerable, and many ethical concerns have emerged regarding the informed consent process used in the experimental design of such trials. Starting with these considerations, this nonsystematic review is aimed at analyzing the decision-making processes underlying patients' decision about whether to participate (or not) in phase I trials in order to clarify the cognitive and emotional aspects most strongly implicated in this decision. Considering that there is no uniform decision calculus and that many different variables other than the patient-physician relationship (including demographic, clinical, and personal characteristics) may influence patients' preferences for and processing of information, we conclude that patients' informed decision-making can be facilitated by creating a rigorously developed, calibrated, and validated computer tool modeled on each single patient's knowledge, values, and emotional and cognitive decisional skills. Such a tool will also help oncologists to provide tailored medical information that is useful to improve the shared decision-making process, thereby possibly increasing patient participation in clinical trials. © 2015 S. Karger AG, Basel.

  3. Combined effects of repeated oral hygiene motivation and type of toothbrush on orthodontic patients: a blind randomized clinical trial.

    Science.gov (United States)

    Marini, Ida; Bortolotti, Francesco; Parenti, Serena Incerti; Gatto, Maria Rosaria; Bonetti, Giulio Alessandri

    2014-09-01

    To investigate the effects on plaque index (PI) scores of manual or electric toothbrush with or without repeated oral hygiene instructions (OHI) and motivation on patients wearing fixed orthodontic appliances. One month after the orthodontic fixed appliance bonding on both arches, 60 patients were randomly assigned to four groups; groups E1 (n  =  15) and E2 (n  =  15) received a powered rotating-oscillating toothbrush, and groups M1 (n  =  15) and M2 (n  =  15) received a manual toothbrush. Groups E1 and M1 received OHI and motivation at baseline (T0) and after 4, 8, 12, 16, and 20 weeks (T4, T8, T12, T16, and T20, respectively) by a Registered Dental Hygienist; groups E2 and M2 received OHI and motivation only at baseline. At each time point a blinded examiner scored plaque of all teeth using the modified Quigley-Hein PI. In all groups the PI score decreased significantly over time, and there were differences among groups at T8, T12, T16, and T20. At T8, PI scores of group E1 were lower than those of group E2, and at T12, T16, and T20, PI scores of groups M1 and E1 were lower compared to those of groups M2 and E2. A linear mixed model showed that the effect of repeated OHI and motivation during time was statistically significant, independently from the use of manual or electric toothbrush. The present results showed that repeated OHI and motivation are crucial in reducing PI score in orthodontic patients, independent of the type of toothbrush used.

  4. Contextualizing willingness to participate: recommendations for engagement, recruitment & enrolment of Kenyan MSM in future HIV prevention trials

    Directory of Open Access Journals (Sweden)

    Monika Doshi

    2017-05-01

    Full Text Available Abstract Background The HIV epidemic among men who have sex with men (MSM continues to expand globally. The addition of an efficacious, prophylactic vaccine to combination prevention offers immense hope, particularly in low- and middle- income countries which bear the greatest global impact. However, in these settings, there is a paucity of vaccine preparedness studies that specifically pertain to MSM. Our study is the first vaccine preparedness study among MSM and female sex workers (FSWs in Kenya. In this paper, we explore willingness of Kenyan MSM to participate in HIV vaccine efficacy trials. In addition to individual and socio-cultural motivators and barriers that influence willingness to participate (WTP, we explore the associations or linkages that participants draw between their experiences with or knowledge of medical research both generally and within the context of HIV/AIDS, their perceptions of a future HIV vaccine and their willingness to participate in HIV vaccine trials. Methods Using a social network-based approach, we employed snowball sampling to recruit MSM into the study from Kisumu, Mombasa, and Nairobi. A field team consisting of seven community researchers conducted in-depth interviews with a total of 70 study participants. A coding scheme for transcribed and translated data was developed and the data was then analysed thematically. Results Most participants felt that an HIV vaccine would bring a number of benefits to self, as well as to MSM communities, including quelling personal fears related to HIV acquisition and reducing/eliminating stigma and discrimination shouldered by their community. Willingness to participate in HIV vaccine efficacy trials was highly motivated by various forms of altruism. Specific researcher responsibilities centred on safe-guarding the rights and well-being of participants were also found to govern WTP, as were reflections on the acceptability of a future preventive HIV vaccine. Conclusion

  5. Participation of older people in preauthorization trials of recently approved medicines

    NARCIS (Netherlands)

    Beers, Erna; Moerkerken, Dineke C; Leufkens, Hubert G M; Egberts, Toine C G; Jansen, Paul A F

    2014-01-01

    OBJECTIVES: To investigate the inclusion of older people in clinical trials of recently authorized medicines, evaluating adherence to the 20-year-old International Conference of Harmonisation (ICH) guideline on geriatrics (E7). DESIGN: Observational. SETTING: European public assessment reports,

  6. Perception of young adults with sickle cell disease or sickle cell trait about participation in the CHOICES randomized controlled trial.

    Science.gov (United States)

    Hershberger, Patricia E; Gallo, Agatha M; Molokie, Robert; Thompson, Alexis A; Suarez, Marie L; Yao, Yingwei; Wilkie, Diana J

    2016-06-01

    To gain an in-depth understanding of the perceptions of young adults with sickle cell disease and sickle cell trait about parenthood and participating in the CHOICES randomized controlled trial that used computer-based, educational programmes. In the USA, there is insufficient education to assure that all young adults with sickle cell disease or sickle cell trait understand genetic inheritance risks and reproductive options to make informed reproductive decisions. To address this educational need, we developed a computer-based, multimedia program (CHOICES) and reformatted usual care into a computer-based (e-Book) program. We then conducted a two-year randomized controlled trial that included a qualitative component that would deepen understanding of young adults' perceptions of parenthood and use of computer-based, educational programmes. A qualitative descriptive approach completed after a randomized controlled trial. Sixty-eight men and women of childbearing age participated in semi-structured interviews at the completion of the randomized controlled trial from 2012-2013. Thematic content analysis guided the qualitative description. Three main themes were identified: (1) increasing knowledge and new ways of thinking and behaving; (2) rethinking parenting plans; and (3) appraising the program design and delivery. Most participants reported increased knowledge and rethinking of their parenting plans and were supportive of computer-based learning. Some participants expressed difficulty in determining individual transmission risks. Participants perceived the computer programs as beneficial to their learning. Future development of an Internet-based educational programme is warranted, with emphasis on providing tailored education or memory boosters about individual transmission risks. © 2015 John Wiley & Sons Ltd.

  7. Patients or volunteers? The impact of motivation for trial participation on the efficacy of patient decision Aids: a secondary analysis of a Cochrane systematic review.

    Science.gov (United States)

    Brown, James G; Joyce, Kerry E; Stacey, Dawn; Thomson, Richard G

    2015-05-01

    Efficacy of patient decision aids (PtDAs) may be influenced by trial participants' identity either as patients seeking to benefit personally from involvement or as volunteers supporting the research effort. To determine if study characteristics indicative of participants' trial identity might influence PtDA efficacy. We undertook exploratory subgroup meta-analysis of the 2011 Cochrane review of PtDAs, including trials that compared PtDA with usual care for treatment decisions. We extracted data on whether participants initiated the care pathway, setting, practitioner interactions, and 6 outcome variables (knowledge, risk perception, decisional conflict, feeling informed, feeling clear about values, and participation). The main subgroup analysis categorized trials as "volunteerism" or "patienthood" on the basis of whether participants initiated the care pathway. A supplementary subgroup analysis categorized trials on the basis of whether any volunteerism factors were present (participants had not initiated the care pathway, had attended a research setting, or had a face-to-face interaction with a researcher). Twenty-nine trials were included. Compared with volunteerism trials, pooled effect sizes were higher in patienthood trials (where participants initiated the care pathway) for knowledge, decisional conflict, feeling informed, feeling clear, and participation. The subgroup difference was statistically significant for knowledge only (P = 0.03). When trials were compared on the basis of whether volunteerism factors were present, knowledge was significantly greater in patienthood trials (P < 0.001), but there was otherwise no consistent pattern of differences in effects across outcomes. There is a tendency toward greater PtDA efficacy in trials in which participants initiate the pathway of care. Knowledge acquisition appears to be greater in trials where participants are predominantly patients rather than volunteers. © The Author(s) 2015.

  8. Barriers to participation in surgical randomized controlled trials in pediatric urology: A qualitative study of key stakeholder perspectives.

    Science.gov (United States)

    Vemulakonda, Vijaya M; Jones, Jacqueline

    2016-06-01

    Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. However, pediatric surgical RCTs have been limited in their ability to recruit patients. The purpose of this study was to identify barriers and motivators to pediatric participation in surgical RCTs. We conducted a series of two focus groups with parents and one focus group with urology providers for children aged analysis of focus group findings. Theme analysis was used for all qualitative transcribed text data obtained from focus groups and open-ended survey questions using team-based inductive approaches. Descriptive statistics were obtained for the remainder of the provider survey. Using qualitative text from stakeholders (n = 38) we identified four key themes across the data: responsibility to my child; responsibility to my patient; responsibility to the field; and irreversibility of surgery. Participants felt there was an obligation to be informed of relevant scientific research within a clinic research culture. However, there remains a disconnect for parents between randomized research studies that may ultimately benefit their child, depending on their age and concern their child is being treated as a 'guinea pig'. Some parents were willing to participate in RCTs but all were more open to participate in an observational study where the treatment decisions were felt to be under their control even when there was no "right answer" or multiple equivalent options for treatment. There was mixed opinion across the parents and providers whether research trial education and enrollment should be provided by the pediatrician or urologist. Active physician decisions were seen as critical within the context of a long term clinical relationship and provision of information of risks and benefits without pressure were considered essential for ethical research by both parents and providers. While some parents are open to participation in surgical RCTs, providers and

  9. What do our patients understand about their trial participation? Assessing patients' understanding of their informed consent consultation about randomised clinical trials.

    Science.gov (United States)

    Behrendt, C; Gölz, T; Roesler, C; Bertz, H; Wünsch, A

    2011-02-01

    Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated in a trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent.

  10. Non-participation in systematic screening for osteoporosis-the ROSE trial

    DEFF Research Database (Denmark)

    Rothmann, M J; Möller, S; Holmberg, T

    2017-01-01

    Population-based screening for osteoporosis is still controversial and has not been implemented. Non-participation in systematic screening was evaluated in 34,229 women age 65-81 years. Although participation rate was high, non-participation was associated with comorbidity, aging other risk facto...

  11. The influence of repeated abutment changes on peri-implant tissue stability: 3-year post-loading results from a multicentre randomised controlled trial.

    Science.gov (United States)

    Bressan, Eriberto; Grusovin, Maria Gabriella; D'Avenia, Ferdinando; Neumann, Konrad; Sbricoli, Luca; Luongo, Giuseppe; Esposito, Marco

    increased marginal bone loss (difference = 0.1 mm, CI 95%: -0.3, 0.5, P = 0.590) or buccal recessions (difference = 0.1 mm, CI 95%: -0.4, 0.7, P = 0.674) at implants with less than 2 mm of keratinised mucosa at loading. Three-year post-loading data showed that repeated abutment disconnections significantly increased bone loss of 0.43 mm, but this difference may not be considered clinically relevant; therefore clinicians can use the procedure they find more convenient for each specific patient. Immediately non-occlusally loaded dental implants are a viable alternative to conventional loading and no increased bone loss or buccal recessions were noticed at implants with less than 2 mm of keratinised mucosa. Conflict of interest statement: This trial was partially funded by Dentsply Sirona Implants, the manufacturer of the implants and other products evaluated in this investigation. However, data belonged to the authors and by no means did the manufacturer interfere with the conduct of the trial or the publication of the results, with the exception of rejecting a proposal to change the protocol, after the trial was started, allowing the use of indexed abutments.

  12. The participation of minors in preventive HIV research trials in South Africa: legal and human rights considerations.

    Science.gov (United States)

    van Wyk, Christa

    2003-01-01

    The constitutional prohibition of experimentation/research without the individual subject's (own) consent is investigated. A distinction is drawn between therapeutic and non-therapeutic research. A minor of 14 is competent to consent independently to medical treatment (which would include therapeutic research), but not to non-therapeutic research. A minor must be at least 18 years to be able to do so. Proxy consent can be secured for the participation of minors under 18 in non-therapeutic research only if they assent, if their participation in the research is indispensable and the research carries no more than negligible risk. Since the risks inherent in HIV preventive vaccine trials may carry more than negligible risk, these trials may not be carried out on children under 18. The limitation of rights and the consideration of foreign and international law in the interpretation of the South African Bill of Rights are investigated.

  13. A qualitative study of decision-making on Phase III randomized clinical trial participation in paediatric oncology

    DEFF Research Database (Denmark)

    Ingersgaard, Marianne Vie; Tulstrup, Morten; Schmiegelow, Kjeld

    2018-01-01

    AIM: To explore parents' and adolescents' motives for accepting/declining participation in the ALL2008 trials and adolescents' involvement in the decision-making process. BACKGROUND: Children and adolescents with acute lymphoblastic leukaemia treated on the Nordic Society of Paediatric Haematology...... the adolescents' decision. There were no differences between motivations of preferences held by parents of children or adolescents, respectively. Decisions were based on subjective values attributed to cure contra toxicity and individual preferences for either standard or experimental treatment. The possibility....... FINDINGS: Adolescents and parents emphasized the importance of adolescents' active participation in decisions regarding enrolment into clinical trials. A majority of adolescents were either final or collaborative decision-makers. Parents stated that in case of disagreement, they would overrule...

  14. Predicting hypothetical willingness to participate (WTP) in a future phase III HIV vaccine trial among high-risk adolescents.

    Science.gov (United States)

    Giocos, Georgina; Kagee, Ashraf; Swartz, Leslie

    2008-11-01

    The present study sought to determine whether the Theory of Planned Behaviour predicted stated hypothetical willingness to participate (WTP) in future Phase III HIV vaccine trials among South African adolescents. Hierarchical logistic regression analyses showed that The Theory of Planned Behaviour (TPB) significantly predicted WTP. Of all the predictors, Subjective norms significantly predicted WTP (OR = 1.19, 95% C.I. = 1.06-1.34). A stepwise logistic regression analysis revealed that Subjective Norms (OR = 1.19, 95% C.I. = 1.07-1.34) and Attitude towards participation in an HIV vaccine trial (OR = 1.32, 95% C.I. = 1.00-1.74) were significant predictors of WTP. The addition of Knowledge of HIV vaccines and HIV vaccine trials, Perceived self-risk of HIV infection, Health-promoting behaviours and Attitudes towards HIV/AIDS yielded non-significant results. These findings provide support for the Theory of Reasoned Action (TRA) and suggest that psychosocial factors may play an important role in WTP in Phase III HIV vaccine trials among adolescents.

  15. Repeat Customer Success in Extension

    Science.gov (United States)

    Bess, Melissa M.; Traub, Sarah M.

    2013-01-01

    Four multi-session research-based programs were offered by two Extension specialist in one rural Missouri county. Eleven participants who came to multiple Extension programs could be called "repeat customers." Based on the total number of participants for all four programs, 25% could be deemed as repeat customers. Repeat customers had…

  16. A comparison of the efficacy of three intervention trial types: postal, group, and one-to-one facilitation, prior management and the impact of message framing and repeat messages on the flock prevalence of lameness in sheep.

    Science.gov (United States)

    Grant, Claire; Kaler, Jasmeet; Ferguson, Eamonn; O'Kane, Holly; Green, Laura Elizabeth

    2018-01-01

    The aim of this study was to evaluate the effectiveness of three knowledge-transfer intervention trial types (postal, group, one-to-one) to promote best practice to treat sheep with footrot. Further aims were to investigate whether farmer behaviour (i.e. management of lameness) before the trial was associated with uptake of best practice and whether the benefits of best practice framed positively or negatively influenced change in behaviour. The intervention was a message developed from evidence and expert opinion. It was entitled "Six steps to sound sheep" and promoted (1) catch sheep within three days of becoming lame, (2) inspect feet without foot trimming, (3) correctly diagnose the cause, (4) treat sheep lame with footrot or interdigital dermatitis with antibiotic injection and spray without foot trimming, (5) record the identity of treated sheep, (6) cull repeatedly lame sheep. In 2013, 4000 randomly-selected English sheep farmers were sent a questionnaire, those who responded were recruited to the postal (1081 farmers) or one-to-one intervention (32 farmers) trials. A random sample of 400 farmers were invited to join the group trial; 78 farmers participated. A follow-up questionnaire was sent to all participants in summer 2014. There were 72%, 65% and 91% useable responses for the postal, group and one-to-one trials respectively. In both 2013 and 2014, the prevalence of lameness was lower in flocks managed by LC1 farmers than LC2 and LC3 farmers. Between 2013 and 2014, the reduction in geometric mean (95% CI) period prevalence of lameness, proportional between flock reduction in lameness and within flock reduction in lameness was greatest in the one-to-one (7.6% (7.1-8.2%) to 4.3% (3.6-5.0%), 35%, 72%) followed by the group (4.5% (3.9-5.0%) to 3.1% (2.4-3.7%), 27%, 55%) and then the postal trial (from 3.5% (3.3-3.7%) to 3.2% (3.1-3.4%), 21%, 43%). There was a marginally greater reduction in lameness in farmers using most of Six steps but slow to treat lame

  17. Impact of Race Versus Education and Race Versus Income on Patients' Motivation to Participate in Clinical Trials.

    Science.gov (United States)

    Kurt, Anita; Kincaid, Hope; Semler, Lauren; Jacoby, Jeanne L; Johnson, Melanie B; Careyva, Beth A; Stello, Brian; Friel, Timothy; Smulian, John C; Knouse, Mark C

    2017-12-26

    Our study investigates whether levels of motivation and barriers to participation in clinical trials vary with patients' education and income. A self-administered survey asked outpatients to rank potential influential factors on a "0" to "4" significance scale for their motivation to participate in clinical trials. Principal component analysis (PCA), analysis of variance (ANOVA), Kruskal-Wallis, and Mann-Whitney U tests analyzed the impact of race, education, and income on their motivation to participate. Analysis included 1841 surveys; most respondents had a high school education or some college, and listed annual income motivation scale 1 scores (p = .0261). Compared with their counterparts, subjects with less education/lower income ranked monetary compensation (p = .0420 and p motivator. Minorities and patients with less education and lower income appear to be more influenced by their desire to please the doctor, the race and sex of the doctor, and the language spoken by the doctor being the same as theirs. For all races, education appeared to have a direct relationship with motivation to participate, except for African-Americans, whose motivation appeared to decline with more education. Income appeared to have an inverse relationship with motivation to participate for all races.

  18. Interim data monitoring to enroll higher-risk participants in HIV prevention trials

    Directory of Open Access Journals (Sweden)

    Umo-Otong John

    2009-06-01

    Full Text Available Abstract Background Lower-than-expected incidence of HIV undermines sample size calculations and compromises the power of a HIV prevention trial. We evaluated the effectiveness of interim monitoring of HIV infection rates and on-going modification of recruitment strategies to enroll women at higher risk of HIV in the Cellulose Sulfate Phase III study in Nigeria. Methods We analyzed prevalence and incidence of HIV and other sexually transmitted infections, demographic and sexual behavior characteristics aggregated over the treatment groups on a quarterly basis. The site investigators were advised on their recruitment strategies based on the findings of the interim analyses. Results A total of 3619 women were screened and 1644 enrolled at the Ikeja and Apapa clinics in Lagos, and at the Central and Peripheral clinics in Port Harcourt. Twelve months after study initiation, the overall incidence of HIV was less than one-third of the pre-study assumption, with rates of HIV that varied substantially between clinics. Due to the low prevalence and incidence rates of HIV, it was decided to close the Ikeja clinic in Lagos and to find new catchment areas in Port Harcourt. This strategy was associated with an almost two-fold increase in observed HIV incidence during the second year of the study. Conclusion Given the difficulties in estimating HIV incidence, a close monitoring of HIV prevalence and incidence rates during a trial is warranted. The on-going modification of recruitment strategies based on the regular analysis of HIV rates appeared to be an efficient method for targeting populations at greatest risk of HIV infection and increasing study power in the Nigeria trial. Trial Registration The trial was registered with the ClinicalTrials.gov registry under #NCT00120770 http://clinicaltrials.gov/ct2/show/NCT00120770

  19. Clinical factors of response in patients with advanced ovarian cancer participating in early phase clinical trials.

    Science.gov (United States)

    George, Angela; Kristeleit, Rebecca; Rafii, Saeed; Michie, Caroline O; Bowen, Rebecca; Michalarea, Vasiliki; van Hagen, Tom; Wong, Mabel; Rallis, Grigorios; Molife, L Rhoda; Lopez, Juanita; Banerji, Udai; Banerjee, Susana N; Gore, Martin E; de Bono, Johann S; Kaye, Stan B; Yap, Timothy A

    2017-05-01

    Drug resistance to conventional anticancer therapies is almost inevitable in patients with advanced ovarian cancer (AOC), limiting their available treatment options. Novel phase I trial therapies within a dedicated drug development unit may represent a viable alternative; however, there is currently little evidence for patient outcomes in such patients. To address this, we undertook a retrospective review of patients with AOC allocated to phase I trials in the Drug Development Unit at Royal Marsden Hospital (RMH) between June 1998 and October 2010. A total of 200 AOC patients with progressive disease were allocated to ≥1 trial each, with a total of 281 allocations. Of these, 135 (68%) patients commenced ≥1 trial (mean 1.4 [1-8]), totaling 216 allocated trials; 65 (32%) patients did not start due to deterioration resulting from rapidly progressive disease (63 patients) or patient choice (2 patients). Response Evaluation Criteria in Solid Tumours (RECIST) complete/partial responses (CR/PR) were observed in 43 (20%) of those starting trials, including those on poly(ADP-ribose) polymerase (PARP) inhibitors (18/79 [23%]), antiangiogenics (9/65 [14%]) and chemotherapy combinations (14/43 [33%]). Factors associated with CR/PR included: fewer prior treatments, platinum-sensitive disease, CR/PR with prior therapy, (the United States-based) Eastern Cooperative Oncology Group (ECOG) performance status score, fewer metastatic sites, higher albumin and haemoglobin levels, lower white cell counts and baseline CA125 levels, germline BRCA1/2 mutations and better RMH Prognostic Score. Mean survival was 32° months for patients who achieved CR/PR. Treatments were generally well tolerated. Most patients with AOC (134/200 [67%]) received ≥1 subsequent line of therapy after phase I trials. Our data suggest that phase I trial referrals should be considered earlier in the AOC treatment pathway and before the onset of rapid disease progression particularly with the emergence of

  20. Evaluating the utility of a patient decision aid for potential participants of a prostate cancer trial (RAVES-TROG 08.03)

    International Nuclear Information System (INIS)

    Sundaresan, Puma; Turner, Sandra; Kneebone, Andrew; Pearse, Maria; Butow, Phyllis

    2011-01-01

    Randomised controlled trials (RCTs) can be hampered by poor patient accrual and retention. Decision aids (DAs) containing simple, evidence-based information, may assist patients with decision-making regarding trial participation. The current DA was of use for 95% of participants. Further evaluation of the DA in a RCT is currently underway.

  1. Health benefit for the child and promotion of the common good were the two most important reasons for participation in the FinIP vaccine trial.

    Science.gov (United States)

    Nieminen, Heta; Syrjänen, Ritva K; Puumalainen, Taneli; Sirén, Päivi; Palmu, Arto A

    2015-07-17

    The Finnish Invasive Pneumococcal disease (FinIP) vaccine trial was a nationwide cluster-randomised double-blind trial designed to demonstrate the effectiveness of pneumococcal conjugate vaccine in vaccinated children and indirect effects in unvaccinated populations. Together with the parallel carriage/AOM trial, over 47,000 children were enrolled, 52% of the initial target. We conducted a questionnaire study to find out which factors affected parents' decision on their child's study participation. A questionnaire designed to evaluate parents' attitudes to vaccine trial participation in general and the FinIP trial in particular was mailed after the trial enrolment period had ended to parents of randomly selected children: 1484 who participated in the trial and 1485 who did not participate. Altogether 1438 parents (48%) responded to the questionnaire. The response rate was higher among FinIP participants (65%, 965/1484) than among FinIP non-participants (32%, 473/1485). The two most important reasons for giving consent to the FinIP trial were the potential benefit of immunisation against pneumococcal diseases (75% of consenters) and the promotion of the common good and public health (11%). The reasons reported as most important for declining consent were suspicions of vaccine safety (36%) and the double-blind trial design (12%). Up to 65% of the non-consenters declared that drug and vaccine trials should not be conducted in children at all. The expected health benefit for the child was by far the most important reason for consenting to the vaccine trial. Safety concern was the main reason for decline. Importance and necessity of clinical drug and vaccine trials among children and the rationale of the blinded studies should be thoroughly explained to the public. This may increase participation in future vaccine trials. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. Effect of personalised citizen assistance for social participation (APIC) on older adults' health and social participation: study protocol for a pragmatic multicentre randomised controlled trial (RCT).

    Science.gov (United States)

    Levasseur, Mélanie; Dubois, Marie-France; Filliatrault, Johanne; Vasiliadis, Helen-Maria; Lacasse-Bédard, Joanie; Tourigny, André; Levert, Marie-Josée; Gabaude, Catherine; Lefebvre, Hélène; Berger, Valérie; Eymard, Chantal

    2018-03-31

    The challenges of global ageing and the growing burden of chronic diseases require innovative interventions acting on health determinants like social participation. Many older adults do not have equitable opportunities to achieve full social participation, and interventions might underempower their personal and environmental resources and only reach a minority. To optimise current practices, the Accompagnement-citoyen Personnalisé d'Intégration Communautaire (APIC), an intervention demonstrated as being feasible and having positive impacts, needs further evaluation. A pragmatic multicentre, prospective, two-armed, randomised controlled trial will evaluate: (1) the short-term and long-term effects of the APIC on older adults' health, social participation, life satisfaction and healthcare services utilisation and (2) its cost-effectiveness. A total of 376 participants restricted in at least one instrumental activity of daily living and living in three large cities in the province of Quebec, Canada, will be randomly assigned to the experimental or control group using a centralised computer-generated random number sequence procedure. The experimental group will receive weekly 3-hour personalised stimulation sessions given by a trained volunteer over the first 12 months. Sessions will encourage empowerment, gradual mobilisation of personal and environmental resources and community integration. The control group will receive the publicly funded universal healthcare services available to all Quebecers. Over 2 years (baseline and 12, 18 and 24 months later), self-administered questionnaires will assess physical and mental health (primary outcome; version 2 of the 36-item Short-Form Health Survey, converted to SF-6D utility scores for quality-adjusted life years), social participation (Social Participation Scale) and life satisfaction (Life Satisfaction Index-Z). Healthcare services utilisation will be recorded and costs of each intervention calculated. The Research

  3. Power, fairness and trust: understanding and engaging with vaccine trial participants and communities in the setting up the EBOVAC-Salone vaccine trial in Sierra Leone

    Directory of Open Access Journals (Sweden)

    Luisa Enria

    2016-11-01

    Full Text Available Abstract Background This paper discusses the establishment of a clinical trial of an Ebola vaccine candidate in Kambia District, Northern Sierra Leone during the epidemic, and analyses the role of social science research in ensuring that lessons from the socio-political context, the recent experience of the Ebola outbreak, and learning from previous clinical trials were incorporated in the development of community engagement strategies. The paper aims to provide a case study of an integrated social science and communications system in the start-up phase of the clinical trial. Methods The paper is based on qualitative research methods including ethnographic observation, interviews with trial participants and key stakeholder interviews. Results Through the case study of EBOVAC Salone, the paper suggests ways in which research can be used to inform communication strategies before and during the setting up of the trial. It explores notions of power, fairness and trust emerging from analysis of the Sierra Leonean context and through ethnographic research, to reflect on three situations in which social scientists and community liaison officers worked together to ensure successful community engagement. Firstly, a section on “power” considers the pitfalls of considering communities as homogeneous and shows the importance of understanding intra-community power dynamics when engaging communities. Secondly, a section on “fairness” shows how local understandings of what is fair can help inform the design of volunteer recruitment strategies. Finally, a section on “trust” highlights how historically rooted rumours can be effectively addressed through active dialogue rather than through an approach focused on correcting misinformation. Conclusion The paper firstly emphasises the value of social science in the setting up of clinical trials, in terms of providing an in depth understanding of context and social dynamics. Secondly, the paper suggests

  4. Patient participation in cancer clinical trials: A pilot test of lay navigation

    Directory of Open Access Journals (Sweden)

    Kathleen B. Cartmell

    2016-08-01

    Conclusions: In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.

  5. Increased intra-participant variability in children with autistic spectrum disorder: Evidence from single trial analyses of evoked EEG.

    Directory of Open Access Journals (Sweden)

    Elizabeth eMilne

    2011-03-01

    Full Text Available Intra-participant variability in clinical conditions such as autistic spectrum disorder (ASD is an important indicator of pathophysiological processing. The data reported here illustrate that trial-by-trial variability can be reliably measured from EEG, and that intra-participant EEG variability is significantly greater in those with ASD than in neuro-typical matched controls. EEG recorded at the scalp is a linear mixture of activity arising from muscle artifacts and numerous concurrent brain processes. To minimise these additional sources of variability, EEG data were subjected to two different methods of spatial filtering. (i The data were decomposed using infomax Independent Component Analysis (ICA, a method of blind source separation which un-mixes the EEG signal into components with maximally independent time-courses, and (ii a surface Laplacian transform was performed (Current Source Density interpolation in order to reduce the effects of volume conduction. Data are presented from thirteen high functioning adolescents with ASD without co-morbid ADHD, and twelve neuro-typical age- IQ- and gender-matched controls. Comparison of variability between the ASD and neuro-typical groups indicated that intra-participant variability of P1 latency and P1 amplitude was greater in the participants with ASD, and inter-trial α-band phase coherence was lower in the participants with ASD. These data support the suggestion that individuals with ASD are less able to synchronise the activity of stimulus-related cell assemblies than neuro-typical individuals, and provide empirical evidence in support of theories of increased neural noise in ASD.

  6. The impact of financial incentives on participants' food purchasing patterns in a supermarket-based randomized controlled trial.

    Science.gov (United States)

    Olstad, Dana Lee; Crawford, David A; Abbott, Gavin; McNaughton, Sarah A; Le, Ha Nd; Ni Mhurchu, Cliona; Pollard, Christina; Ball, Kylie

    2017-08-25

    The impacts of supermarket-based nutrition promotion interventions might be overestimated if participants shift their proportionate food purchasing away from their usual stores. This study quantified whether participants who received price discounts on fruits and vegetables (FV) in the Supermarket Healthy Eating for Life (SHELf) randomized controlled trial (RCT) shifted their FV purchasing into study supermarkets during the intervention period. Participants were 642 females randomly assigned to a 1) skill-building (n = 160), 2) price reduction (n = 161), 3) combined skill-building and price reduction (n = 160), or 4) control (n = 161) group. Participants self-reported the proportion of FV purchased in study supermarkets at baseline, 3- and 6-months post-intervention. Fisher's exact and χ 2 tests assessed differences among groups in the proportion of FV purchased in study supermarkets at each time point. Multinomial logistic regression assessed differences among groups in the change in proportionate FV purchasing over time. Post-intervention, 49% of participants purchased ≥50% of their FV in study supermarkets. Compared to all other groups, the price reduction group was approximately twice as likely (RRR: 1.8-2.2) to have increased proportionate purchasing of FV in study supermarkets from baseline to post-intervention (psupermarkets during the intervention period. Unless food purchasing data are available for all sources, differential changes in purchasing patterns can make it difficult to discern the true impacts of nutrition interventions. The SHELf trial is registered with Current Controlled Trials Registration ISRCTN39432901, Registered 30 June 2010, Retrospectively registered ( http://www.isrctn.com/ISRCTN39432901 ).

  7. Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.

    Directory of Open Access Journals (Sweden)

    Neil E O'Connell

    Full Text Available BACKGROUND: Many double-blind clinical trials of transcranial direct current stimulation (tDCS use stimulus intensities of 2 mA despite the fact that blinding has not been formally validated under these conditions. The aim of this study was to test the assumption that sham 2 mA tDCS achieves effective blinding. METHODS: A randomised double blind crossover trial. 100 tDCS-naïve healthy volunteers were incorrectly advised that they there were taking part in a trial of tDCS on word memory. Participants attended for two separate sessions. In each session, they completed a word memory task, then received active or sham tDCS (order randomised at 2 mA stimulation intensity for 20 minutes and then repeated the word memory task. They then judged whether they believed they had received active stimulation and rated their confidence in that judgement. The blinded assessor noted when red marks were observed at the electrode sites post-stimulation. RESULTS: tDCS at 2 mA was not effectively blinded. That is, participants correctly judged the stimulation condition greater than would be expected to by chance at both the first session (kappa level of agreement (κ 0.28, 95% confidence interval (CI 0.09 to 0.47 p=0.005 and the second session (κ=0.77, 95%CI 0.64 to 0.90, p=<0.001 indicating inadequate participant blinding. Redness at the reference electrode site was noticeable following active stimulation more than sham stimulation (session one, κ=0.512, 95%CI 0.363 to 0.66, p<0.001; session two, κ=0.677, 95%CI 0.534 to 0.82 indicating inadequate assessor blinding. CONCLUSIONS: Our results suggest that blinding in studies using tDCS at intensities of 2 mA is inadequate. Positive results from such studies should be interpreted with caution.

  8. Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia.

    Science.gov (United States)

    Mboizi, Robert B; Afolabi, Muhammed O; Okoye, Michael; Kampmann, Beate; Roca, Anna; Idoko, Olubukola T

    2017-09-02

    Communicating essential research information to low literacy research participants in Africa is highly challenging, since this population is vulnerable to poor comprehension of consent information. Several supportive materials have been developed to aid participant comprehension in these settings. Within the framework of a pneumococcal vaccine trial in The Gambia, we evaluated the recall and decay of consent information during the trial which used an audio-visual tool called 'Speaking Book', to foster comprehension among parents of participating infants. The Speaking Book was developed in the 2 most widely spoken local languages. Four-hundred and 9 parents of trial infants gave consent to participate in this nested study and were included in the baseline assessment of their knowledge about trial participation. An additional assessment was conducted approximately 90 d later, following completion of the clinical trial protocol. All parents received a Speaking Book at the start of the trial. Trial knowledge was already high at the baseline assessment with no differences related to socio-economic status or education. Knowledge of key trial information was retained at the completion of the study follow-up. The Speaking Book (SB) was well received by the study participants. We hypothesize that the SB may have contributed to the retention of information over the trial follow-up. Further studies evaluating the impact of this innovative tool are thus warranted.

  9. Efficacy of Repeated Botulinum Toxin Type A Injections for Spastic Equinus in Children with Cerebral Palsy-A Secondary Analysis of the Randomized Clinical Trial.

    Science.gov (United States)

    Hong, Bo Young; Chang, Hyun Jung; Lee, Sang-Jee; Lee, Soyoung; Park, Joo Hyun; Kwon, Jeong-Yi

    2017-08-21

    Botulinum toxin A is considered an important tool to control spasticity in children with cerebral palsy. Several factors are known to affect the efficacy of botulinum toxin, such as dosage, appropriate muscle selection and application, age, and accompanying therapy. A multicenter, double-blind, randomized, prospective phase III clinical trial of botulinum toxin A for the treatment of dynamic equinus in 144 children with cerebral palsy was performed to compare the efficacies of letibotulinumtoxin A and onabotulinumtoxin A. Secondary analyses were performed to evaluate factors that affected the outcome, focusing on the number of times injections were repeated. Effectiveness was defined as a change of 2 or more in the physician's rating scale. Multivariate regression analyses were performed with multiple variables. The first injection of botulinum toxin A significantly improved D subscale of Gross Motor Function Measure-88 scores at 3 months compared to repeated injections ( p < 0.05). After 6 months, patients who had one injection or none before the study showed significantly better outcomes than those who had more than one injection in terms of observational gait scores.

  10. Retention of clinical trial participants in a study of nongonococcal urethritis (NGU), a sexually transmitted infection in men.

    Science.gov (United States)

    Lee, Jeannette Y; Lensing, Shelly Y; Schwebke, Jane R

    2012-07-01

    Nongonococcal urethritis (NGU), an inflammation of the urethra not caused by gonorrhea, is the most common urethritis syndrome seen in men in the United States. It is a sexually transmitted infection commonly caused by Chlamydia trachomatis, a pathogen which occurs more frequently in African-American men compared to white men. The purpose of this study was to investigate factors related to retention of study participants in a randomized, double-blinded clinical trial that evaluated four treatment regimens for the treatment of NGU. After the one-week treatment period, follow-up visits were scheduled during days 15-19 and days 35-45. Participants were phoned prior to scheduled appointments to encourage attendance, and contacted after missed appointments to reschedule their clinic visits. Of the 305 male study participants, 298 (98%) were African-American, 164 (54%) were 25 years of age or younger, and 80 (31%) had a post-secondary school education. The overall retention rate was 75%. Factors associated with study completion were educational level attained and clinical center. Participants with higher levels of education were more likely to complete the study. Clinical centers with the highest retention rates also provided the highest monetary incentives for participation. The retention rate for this study suggests that strategies are needed for improving the proportion of study participants that complete a clinical trial among young men with a sexually transmitted disease. These strategies may include increasing contacts with study participants to remind them of scheduled study visits using text messaging or social media and the use of financial incentives. Copyright © 2012 Elsevier Inc. All rights reserved.

  11. Complementary and alternative healthcare use by participants in the PACE trial of treatments for chronic fatigue syndrome.

    Science.gov (United States)

    Lewith, G; Stuart, B; Chalder, T; McDermott, C; White, P D

    2016-08-01

    Chronic Fatigue Syndrome (CFS) is characterised by persistent fatigue, disability and a range of other symptoms. The PACE trial was randomised to compare four non-pharmacological treatments for patients with CFS in secondary care clinics. The aims of this sub study were to describe the use of complementary and alternative medicine (CAM) in the trial sample and to test whether CAM use correlated with an improved outcome. CAM use was recorded at baseline and 52weeks. Logistic and multiple regression models explored relationships between CAM use and both patient characteristics and trial outcomes. At baseline, 450/640 (70%) of participants used any sort of CAM; 199/640 (31%) participants were seeing a CAM practitioner and 410/640 (64%) were taking a CAM medication. At 52weeks, those using any CAM fell to 379/589 (64%). Independent predictors of CAM use at baseline were female gender, local ME group membership, prior duration of CFS and treatment preference. At 52weeks, the associated variables were being female, local ME group membership, and not being randomised to the preferred trial arm. There were no significant associations between any CAM use and fatigue at either baseline or 52weeks. CAM use at baseline was associated with a mean (CI) difference of 4.10 (1.28, 6.91; p=0.024) increased SF36 physical function score at 52weeks, which did not reach the threshold for a clinically important difference. CAM use is common in patients with CFS. It was not associated with any clinically important trial outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Enhanced 400-m sprint performance in moderately trained participants by a 4-day alkalizing diet: a counterbalanced, randomized controlled trial.

    Science.gov (United States)

    Limmer, Mirjam; Eibl, Angi Diana; Platen, Petra

    2018-05-31

    Sodium bicarbonate (NaHCO 3 ) is an alkalizing agent and its ingestion is used to improve anaerobic performance. However, the influence of alkalizing nutrients on anaerobic exercise performance remains unclear. Therefore, the present study investigated the influence of an alkalizing versus acidizing diet on 400-m sprint performance, blood lactate, blood gas parameters, and urinary pH in moderately trained adults. In a randomized crossover design, eleven recreationally active participants (8 men, 3 women) aged 26.0 ± 1.7 years performed one trial under each individual's unmodified diet and subsequently two trials following either 4 days of an alkalizing (BASE) or acidizing (ACID) diet. Trials consisted of 400-m runs at intervals of 1 week on a tartan track in a randomized order. We found a significantly lower 400-m performance time for the BASE trial (65.8 ± 7.2 s) compared with the ACID trial (67.3 ± 7.1 s; p = 0.026). In addition, responses were significantly higher following the BASE diet for blood lactate (BASE: 16.3 ± 2.7; ACID: 14.4 ± 2.1 mmol/L; p = 0.32) and urinary pH (BASE: 7.0 ± 0.7; ACID: 5.5 ± 0.7; p = 0.001). We conclude that a short-term alkalizing diet may improve 400-m performance time in moderately trained participants. Additionally, we found higher blood lactate concentrations under the alkalizing diet, suggesting an enhanced blood or muscle buffer capacity. Thus, an alkalizing diet may be an easy and natural way to enhance 400-m sprint performance for athletes without the necessity of taking artificial dietary supplements.

  13. Sharing individual participant data from clinical trials: an opinion survey regarding the establishment of a central repository.

    Science.gov (United States)

    Tudur Smith, Catrin; Dwan, Kerry; Altman, Douglas G; Clarke, Mike; Riley, Richard; Williamson, Paula R

    2014-01-01

    Calls have been made for increased access to individual participant data (IPD) from clinical trials, to ensure that complete evidence is available. However, despite the obvious benefits, progress towards this is frustratingly slow. In the meantime, many systematic reviews have already collected IPD from clinical trials. We propose that a central repository for these IPD should be established to ensure that these datasets are safeguarded and made available for use by others, building on the strengths and advantages of the collaborative groups that have been brought together in developing the datasets. Evaluate the level of support, and identify major issues, for establishing a central repository of IPD. On-line survey with email reminders. 71 reviewers affiliated with the Cochrane Collaboration's IPD Meta-analysis Methods Group were invited to participate. 30 (42%) invitees responded: 28 (93%) had been involved in an IPD review and 24 (80%) had been involved in a randomised trial. 25 (83%) agreed that a central repository was a good idea and 25 (83%) agreed that they would provide their IPD for central storage. Several benefits of a central repository were noted: safeguarding and standardisation of data, increased efficiency of IPD meta-analyses, knowledge advancement, and facilitating future clinical, and methodological research. The main concerns were gaining permission from trial data owners, uncertainty about the purpose of the repository, potential resource implications, and increased workload for IPD reviewers. Restricted access requiring approval, data security, anonymisation of data, and oversight committees were highlighted as issues under governance of the repository. There is support in this community of IPD reviewers, many of whom are also involved in clinical trials, for storing IPD in a central repository. Results from this survey are informing further work on developing a repository of IPD which is currently underway by our group.

  14. Sharing individual participant data from clinical trials: an opinion survey regarding the establishment of a central repository.

    Directory of Open Access Journals (Sweden)

    Catrin Tudur Smith

    Full Text Available Calls have been made for increased access to individual participant data (IPD from clinical trials, to ensure that complete evidence is available. However, despite the obvious benefits, progress towards this is frustratingly slow. In the meantime, many systematic reviews have already collected IPD from clinical trials. We propose that a central repository for these IPD should be established to ensure that these datasets are safeguarded and made available for use by others, building on the strengths and advantages of the collaborative groups that have been brought together in developing the datasets.Evaluate the level of support, and identify major issues, for establishing a central repository of IPD.On-line survey with email reminders.71 reviewers affiliated with the Cochrane Collaboration's IPD Meta-analysis Methods Group were invited to participate.30 (42% invitees responded: 28 (93% had been involved in an IPD review and 24 (80% had been involved in a randomised trial. 25 (83% agreed that a central repository was a good idea and 25 (83% agreed that they would provide their IPD for central storage. Several benefits of a central repository were noted: safeguarding and standardisation of data, increased efficiency of IPD meta-analyses, knowledge advancement, and facilitating future clinical, and methodological research. The main concerns were gaining permission from trial data owners, uncertainty about the purpose of the repository, potential resource implications, and increased workload for IPD reviewers. Restricted access requiring approval, data security, anonymisation of data, and oversight committees were highlighted as issues under governance of the repository.There is support in this community of IPD reviewers, many of whom are also involved in clinical trials, for storing IPD in a central repository. Results from this survey are informing further work on developing a repository of IPD which is currently underway by our group.

  15. Decision Making in the PICU: An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical Trials

    Science.gov (United States)

    Slosky, Laura E.; Burke, Natasha L.; Siminoff, Laura A.

    2014-01-01

    Background. In stressful situations, decision making processes related to informed consent may be compromised. Given the profound levels of distress that surrogates of children in pediatric intensive care units (PICU) experience, it is important to understand what factors may be influencing the decision making process beyond the informed consent. The purpose of this study was to evaluate the role of clinician influence and other factors on decision making regarding participation in a randomized clinical trial (RCT). Method. Participants were 76 children under sedation in a PICU and their surrogate decision makers. Measures included the Post Decision Clinician Survey, observer checklist, and post-decision interview. Results. Age of the pediatric patient was related to participation decisions in the RCT such that older children were more likely to be enrolled. Mentioning the sponsoring institution was associated with declining to participate in the RCT. Type of health care provider and overt recommendations to participate were not related to enrollment. Conclusion. Decisions to participate in research by surrogates of children in the PICU appear to relate to child demographics and subtleties in communication; however, no modifiable characteristics were related to increased participation, indicating that the informed consent process may not be compromised in this population. PMID:25161672

  16. Patient advocacy and patient centredness in participant recruitment to randomized-controlled trials: implications for informed consent.

    Science.gov (United States)

    Tomlin, Zelda; deSalis, Isabel; Toerien, Merran; Donovan, Jenny L

    2014-10-01

    With the routinization of evidence-based medicine and of the randomized-controlled trial (RCT), more patients are becoming 'sites of evidence production' yet, little is known about how they are recruited as participants; there is some evidence that 'substantively valid consent' is difficult to achieve. To explore the views and experiences of nurses recruiting patients to randomized-controlled trials and to examine the extent to which their recruitment practices were patient-centred and patient empowering. Semi-structured in-depth interviews; audio recording of recruitment appointments; thematic interactional analysis (drawing on discourse and conversation analysis). Nurses recruiting patients to five publicly funded RCTs and patients consenting to the recording of their recruitment sessions. The views of recruiting nurses about their recruitment role; the extent to which nurse-patient interactions were patient-centred; the nature of the nurses' interactional strategies and the nature and extent of patient participation in the discussion. The nurses had a keen sense of themselves as clinicians and patient advocates and their perceptions of the trial and its interventions were inextricably linked to those of the patients. However, many of their recruitment practices made it difficult for patients to play an active and informed part in the discussion about trial participation, raising questions over the quality of consent decisions. Nurses working in patient recruitment to RCTs need to reconcile two different worlds with different demands and ethics. Evidence production, a central task in evidence-based medicine, poses a challenge to patient-centred practice and more research and relevant training are needed. © 2012 John Wiley & Sons Ltd.

  17. Informed consent from cognitively impaired persons participating in research trials: comparative law observations.

    Science.gov (United States)

    Petrini, Carlo

    2011-01-01

    This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  18. Informed consent from cognitively impaired persons participating in research trials: comparative law observations

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2011-12-01

    Full Text Available This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  19. Recruitment and retention of participants for an international type 1 diabetes prevention trial

    DEFF Research Database (Denmark)

    Franciscus, Margaret; Nucci, Anita; Bradley, Brenda

    2014-01-01

    for long-term follow-up assessments. PURPOSE: Our purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators. METHODS: TRIGR was designed to test whether weaning to formula containing hydrolyzed versus intact cow's milk protein......BACKGROUND: The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of eligible pregnant women and enrollment of newborns......-year follow-up phases of this study. The TRIGR study met the accrual goal after 4.7 years of recruitment, 2.7 years longer than projected initially. Challenges included difficulty in finding fathers with T1D, a higher than expected rate of premature delivery among T1D mothers, and implementation of new...

  20. A cluster-based randomized controlled trial promoting community participation in arsenic mitigation efforts in Bangladesh

    OpenAIRE

    George, Christine Marie; van Geen, Alexander; Slavkovich, Vesna; Singha, Ashit; Levy, Diane; Islam, Tariqul; Ahmed, Kazi Matin; Moon-Howard, Joyce; Tarozzi, Alessandro; Liu, Xinhua; Factor-Litvak, Pam; Graziano, Joseph

    2012-01-01

    Abstract Objective To reduce arsenic (As) exposure, we evaluated the effectiveness of training community members to perform water arsenic (WAs) testing and provide As education compared to sending representatives from outside communities to conduct these tasks. Methods We conducted a cluster based randomized controlled trial of 20 villages in Singair, Bangladesh. Fifty eligible respondents were randomly selected in each village. In 10 villages, a community member provided As education and WAs...

  1. Prevalence of potentially inappropriate prescribing in a subpopulation of older European clinical trial participants: a cross-sectional study.

    Science.gov (United States)

    O Riordan, David; Aubert, Carole Elodie; Walsh, Kieran A; Van Dorland, Anette; Rodondi, Nicolas; Du Puy, Robert S; Poortvliet, Rosalinde K E; Gussekloo, Jacobijn; Sinnott, Carol; Byrne, Stephen; Galvin, Rose; Jukema, J Wouter; Mooijaart, Simon P; Baumgartner, Christine; McCarthy, Vera; Walsh, Elaine K; Collet, Tinh-Hai; Dekkers, Olaf M; Blum, Manuel R; Kearney, Patricia M

    2018-03-22

    To estimate and compare the prevalence and type of potentially inappropriate prescribing (PIP) and potential prescribing omissions (PPOs) among community-dwelling older adults (≥65 years) enrolled to a clinical trial in three European countries. A secondary analysis of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial dataset. A subset of 48/80 PIP and 22/34 PPOs indicators from the Screening Tool of Older Persons Prescriptions/Screening Tool to Alert doctors to Right Treatment (STOPP/START) V2 criteria were applied to prescribed medication data for 532/737 trial participants in Ireland, Switzerland and the Netherlands. The overall prevalence of PIP was lower in the Irish participants (8.7%) compared with the Swiss (16.7%) and Dutch (12.5%) participants (P=0.15) and was not statistically significant. The overall prevalence of PPOs was approximately one-quarter in the Swiss (25.3%) and Dutch (24%) participants and lower in the Irish (14%) participants (P=0.04) and the difference was statistically significant. The hypnotic Z-drugs were the most frequent PIP in Irish participants, (3.5%, n=4), while it was non-steroidal anti-inflammatory drug and oral anticoagulant combination, sulfonylureas with a long duration of action, and benzodiazepines (all 4.3%, n=7) in Swiss, and benzodiazepines (7.1%, n=18) in Dutch participants. The most frequent PPOs in Irish participants were vitamin D and calcium in osteoporosis (3.5%, n=4). In the Swiss and Dutch participants, they were bone antiresorptive/anabolic therapy in osteoporosis (9.9%, n=16, 8.6%, n=22) respectively. The odds of any PIP after adjusting for age, sex, multimorbidity and polypharmacy were (adjusted OR (aOR)) 3.04 (95% CI 1.33 to 6.95, P<0.01) for Swiss participants and aOR 1.74 (95% CI 0.79 to 3.85, P=0.17) for Dutch participants compared with Irish participants. The odds of any PPOs were aOR 2.48 (95% CI 1.27 to 4.85, P<0.01) for Swiss participants and aOR 2.10 (95% CI 1.11 to 3.96, P=0

  2. HIV vaccine research--South Africa's ethical-legal framework and its ability to promote the welfare of trial participants.

    Science.gov (United States)

    Strode, Ann; Slack, Catherine; Mushariwa, Muriel

    2005-08-01

    An effective ethical-legal framework for the conduct of research is critical. We describe five essential components of such a system, review the extent to which these components have been realised in South Africa, present brief implications for the ethical conduct of clinical trials of HIV vaccines in South Africa and make recommendations. The components of an effective ethical-legal system that we propose are the existence of scientific ethical and policy-making structures that regulate research; research ethics committees (RECs) that ethically review research; national ethical guidelines and standards; laws protecting research participants; and mechanisms to enforce and monitor legal rights and ethical standards. We conclude that the ethical-legal framework has, for the most part, the necessary institutions, and certain necessary guidelines but does not have many of the laws needed to protect and promote the rights of persons participating in research, including HIV vaccine trials. Recommendations made include advocacy measures to finalise and implement legislation, development of regulations, analysis and comparison of ethical guidelines, and the development of measures to monitor ethical-legal rights at trial sites.

  3. Motives for participating in a clinical research trial: a pilot study in Brazil

    Directory of Open Access Journals (Sweden)

    Nappo Solange A

    2013-01-01

    Full Text Available Abstract Background In the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil. Methods Mixed-methods research was used (a qualitative-quantitative approach. A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing. Results The motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS. However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study. Conclusions The present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study

  4. Motives for participating in a clinical research trial: a pilot study in Brazil.

    Science.gov (United States)

    Nappo, Solange A; Iafrate, Giovanna B; Sanchez, Zila M

    2013-01-10

    In the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil. Mixed-methods research was used (a qualitative-quantitative approach). A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing. The motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS). However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study. The present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study participants had an integral understanding of the ICS is not clear.

  5. Two to five repeated measurements per patient reduced the required sample size considerably in a randomized clinical trial for patients with inflammatory rheumatic diseases

    Directory of Open Access Journals (Sweden)

    Smedslund Geir

    2013-02-01

    Full Text Available Abstract Background Patient reported outcomes are accepted as important outcome measures in rheumatology. The fluctuating symptoms in patients with rheumatic diseases have serious implications for sample size in clinical trials. We estimated the effects of measuring the outcome 1-5 times on the sample size required in a two-armed trial. Findings In a randomized controlled trial that evaluated the effects of a mindfulness-based group intervention for patients with inflammatory arthritis (n=71, the outcome variables Numerical Rating Scales (NRS (pain, fatigue, disease activity, self-care ability, and emotional wellbeing and General Health Questionnaire (GHQ-20 were measured five times before and after the intervention. For each variable we calculated the necessary sample sizes for obtaining 80% power (α=.05 for one up to five measurements. Two, three, and four measures reduced the required sample sizes by 15%, 21%, and 24%, respectively. With three (and five measures, the required sample size per group was reduced from 56 to 39 (32 for the GHQ-20, from 71 to 60 (55 for pain, 96 to 71 (73 for fatigue, 57 to 51 (48 for disease activity, 59 to 44 (45 for self-care, and 47 to 37 (33 for emotional wellbeing. Conclusions Measuring the outcomes five times rather than once reduced the necessary sample size by an average of 27%. When planning a study, researchers should carefully compare the advantages and disadvantages of increasing sample size versus employing three to five repeated measurements in order to obtain the required statistical power.

  6. Attitudes of Patients in Developing Countries Toward Participating in Clinical Trials: A Survey of Saudi Patients Attending Primary Health Care Services

    Directory of Open Access Journals (Sweden)

    Lateefa O. Al-Dakhil

    2016-07-01

    Full Text Available Objectives: Clinical trials are experimental projects that include patients as subjects. A number of benefits are directly associated with clinical trials. Healthcare processes and outcomes can be improved with the help of clinical trials. This study aimed to assess the attitudes and beliefs of patients about their contribution to and enrolment in clinical trials. Methods: A cross-sectional study design was used for data collection and analysis. A questionnaire was developed with six categories to derive effective outcomes. Results: Of the 2000 participants approached to take part in the study, 1081 agreed. The majority of the study population was female, well educated, and unaware of clinical trials. Only 324 subjects (30.0% had previously agreed to participate in a clinical trial. The majority (87.1% were motivated to participate in clinical trials due to religious aspects. However, fear of any risk was the principal reason (79.8% that reduced their motivation to participate. Conclusions: The results of this study revealed that patients in Saudi Arabia have a low awareness and are less willing to participate in clinical trials. Different motivational factors and awareness programs can be used to increase patient participation in the future.

  7. A Four-Session Sleep Intervention Program Improves Sleep for Older Adult Day Health Care Participants: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Martin, Jennifer L; Song, Yeonsu; Hughes, Jaime; Jouldjian, Stella; Dzierzewski, Joseph M; Fung, Constance H; Rodriguez Tapia, Juan Carlos; Mitchell, Michael N; Alessi, Cathy A

    2017-08-01

    To test the effectiveness of a 4-week behavioral Sleep Intervention Program (SIP: sleep compression, modified stimulus control, and sleep hygiene) compared to a 4-week information-only control (IC) among older adults attending a VA Adult Day Health Care (ADHC) program in a double-blind, randomized, clinical trial. Forty-two individuals (mean age: 77 years, 93% male) enrolled in a VA ADHC program were randomized to receive SIP or IC. All completed in-person sleep and health assessments at baseline, post-treatment and 4-months follow-up that included 3 days/nights of wrist actigraphy, the Pittsburgh Sleep Quality Index (PSQI), and the Insomnia Severity Index (ISI). Mixed repeated measures analysis was used to compare sleep outcomes at post-treatment and 4-months follow-up, with baseline values as covariates. SIP participants (n = 21) showed significant improvement on actigraphy sleep efficiency (p = .007), number of nighttime awakenings (p = .016), and minutes awake at night (p = .001) at post-treatment, compared to IC participants (n = 21). Benefits were slightly attenuated but remained significant at 4-month follow-up (all p's sleep time between groups. There was significant improvement on PSQI factor 3 (daily disturbances) at 4-month follow-up (p = .016), but no differences were observed between SIP and IC on other PSQI components or ISI scores at post-treatment or 4-month follow-up. A short behavioral sleep intervention may have important benefits in improving objectively measured sleep in older adults participating in ADHC. Future studies are needed to study implementation of this intervention into routine clinical care within ADHC. Published by Oxford University Press on behalf of Sleep Research Society (SRS) 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  8. CREDITOR DEBTS PRE-TRIAL SETTLEMENT BY PARTICIPANTS OF FINANCIAL AND CREDIT RELATIONS: IMPROVEMENT MECHANISMS

    Directory of Open Access Journals (Sweden)

    V. N. Alferov

    2012-01-01

    Full Text Available If a borrower who is in the state of insolvency performs his obligations under loan agreements, cases of challenging the debtor’s transactions may arise. It is expedient to use in Russia international experience of informal financial recovery for pre-trial financial rehabilitation of debtors. The rehabilitation includes three steps: continuous monitoring of the borrowers’ financial state by regional councils of directors and the court (or only by creditors; development and signing of rehabilitation plan and peaceful agreement; control over performance of the agreement by thedebtor. Anti-crisis management expert’s services may be helpful.

  9. Exercise motivation and adherence in cancer survivors after participation in a randomized controlled trial: an attribution theory perspective.

    Science.gov (United States)

    Courneya, Kerry S; Friedenreich, Christine M; Sela, Rami A; Quinney, H Arthur; Rhodes, Ryan E; Jones, Lee W

    2004-01-01

    The purpose of this study was to examine postprogram exercise motivation and adherence in cancer survivors who participated in the Group Psychotherapy and Home-Based Physical Exercise (GROUP-HOPE; Courneya, Friedenreich, Sela, Quinney, & Rhodes, 2002) trial. At the completion of the GROUP-HOPE trial, 46 of 51 (90%) participants in the exercise group completed measures of attribution theory constructs. A 5-week follow-up self-report of exercise was then completed by 30 (65%) participants. Correlational analyses indicated that program exercise, perceived success, expected success, and affective reactions were strong predictors of postprogram exercise. In multivariate stepwise regression analyses, program exercise and perceived success were the strongest predictors of postprogram exercise. Additionally, perceived success was more important than objective success in understanding the attribution process, and it interacted with personal control to influence expected success and negative affect. Finally, postprogram quality of life and changes in physical fitness were correlates of perceived success. We concluded that attribution theory may have utility for understanding postprogram exercise motivation and adherence in cancer survivors.

  10. Community sensitization and decision-making for trial participation: a mixed-methods study from The Gambia.

    Science.gov (United States)

    Dierickx, Susan; O'Neill, Sarah; Gryseels, Charlotte; Immaculate Anyango, Edna; Bannister-Tyrrell, Melanie; Okebe, Joseph; Mwesigwa, Julia; Jaiteh, Fatou; Gerrets, René; Ravinetto, Raffaella; D'Alessandro, Umberto; Peeters Grietens, Koen

    2017-08-16

    Ensuring individual free and informed decision-making for research participation is challenging. It is thought that preliminarily informing communities through 'community sensitization' procedures may improve individual decision-making. This study set out to assess the relevance of community sensitization for individual decision-making in research participation in rural Gambia. This anthropological mixed-methods study triangulated qualitative methods and quantitative survey methods in the context of an observational study and a clinical trial on malaria carried out by the Medical Research Council Unit Gambia. Although 38.7% of the respondents were present during sensitization sessions, 91.1% of the respondents were inclined to participate in the trial when surveyed after the sensitization and prior to the informed consent process. This difference can be explained by the informal transmission of information within the community after the community sensitization, expectations such as the benefits of participation based on previous research experiences, and the positive reputation of the research institute. Commonly mentioned barriers to participation were blood sampling and the potential disapproval of the household head. Community sensitization is effective in providing first-hand, reliable information to communities as the information is cascaded to those who could not attend the sessions. However, further research is needed to assess how the informal spread of information further shapes people's expectations, how the process engages with existing social relations and hierarchies (e.g. local political power structures; permissions of heads of households) and how this influences or changes individual consent. © 2017 The Authors Developing World Bioethics Published by John Wiley & Sons Ltd.

  11. Participant-selected music and physical activity in older adults following cardiac rehabilitation: a randomized controlled trial.

    Science.gov (United States)

    Clark, Imogen N; Baker, Felicity A; Peiris, Casey L; Shoebridge, Georgie; Taylor, Nicholas F

    2017-03-01

    To evaluate effects of participant-selected music on older adults' achievement of activity levels recommended in the physical activity guidelines following cardiac rehabilitation. A parallel group randomized controlled trial with measurements at Weeks 0, 6 and 26. A multisite outpatient rehabilitation programme of a publicly funded metropolitan health service. Adults aged 60 years and older who had completed a cardiac rehabilitation programme. Experimental participants selected music to support walking with guidance from a music therapist. Control participants received usual care only. The primary outcome was the proportion of participants achieving activity levels recommended in physical activity guidelines. Secondary outcomes compared amounts of physical activity, exercise capacity, cardiac risk factors, and exercise self-efficacy. A total of 56 participants, mean age 68.2 years (SD = 6.5), were randomized to the experimental ( n = 28) and control groups ( n = 28). There were no differences between groups in proportions of participants achieving activity recommended in physical activity guidelines at Week 6 or 26. Secondary outcomes demonstrated between-group differences in male waist circumference at both measurements (Week 6 difference -2.0 cm, 95% CI -4.0 to 0; Week 26 difference -2.8 cm, 95% CI -5.4 to -0.1), and observed effect sizes favoured the experimental group for amounts of physical activity (d = 0.30), exercise capacity (d = 0.48), and blood pressure (d = -0.32). Participant-selected music did not increase the proportion of participants achieving recommended amounts of physical activity, but may have contributed to exercise-related benefits.

  12. A trial for improving the rate of participation in breast cancer screening

    International Nuclear Information System (INIS)

    Aki, Fuminori; Ito, Sueyoshi; Kaneko, Akira; Yamakawa, Takashi; Sugimoto, Takeki

    2007-01-01

    In order to search for a good method of increasing the rate of participation in breast cancer screening, we reviewed our previous records of breast cancer screening carried out by inspection and palpation during the preceding 32-year period. Screening by mammography was started in 2004, and in the following year became employed in all districts of Kochi Prefecture. When mammography screening began, we hoped that the participation rate would be at least 20%, which was the level when breast cancer screening was performed by inspection and palpation. In fact, the participation rate was as high as 27.6% in the period 2004-2005, and the breast cancer detection rate was 0.38%. We think that this high participation rate was achieved through complete transition from screening by inspection and palpation to that by mammography, offering guidance to district health nurses and local government administrative staff, education of the public about the importance of breast self-palpation, and other informative activities. (author)

  13. Development of a Multilevel Intervention to Increase HIV Clinical Trial Participation among Rural Minorities

    Science.gov (United States)

    Corbie-Smith, Giselle; Odeneye, Ebun; Banks, Bahby; Shandor Miles, Margaret; Roman Isler, Malika

    2013-01-01

    Minorities are disproportionately affected by HIV/AIDS in the rural Southeast; therefore, it is important to develop targeted, culturally appropriate interventions to support rural minority participation in HIV/AIDS research. Using intervention mapping, we developed a comprehensive multilevel intervention for service providers (SPs) and people…

  14. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos.

    Directory of Open Access Journals (Sweden)

    Felicity L Bishop

    Full Text Available Placebo groups are used in randomised clinical trials (RCTs to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects.We conducted a content analysis of 45 Participant Information Leaflets (PILs using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database. Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%, but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50:50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001 and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001 or adverse effects (4 vs. 39, p<001. 8 PILs (18% explicitly stated that the placebo treatment was either undesirable or ineffective.PILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled

  15. A Pilot Study to Determine the Effect of an Educational DVD in Philippine Languages on Cancer Clinical Trial Participation among Filipinos in Hawai'i.

    Science.gov (United States)

    Felicitas-Perkins, Jamie Q; Palalay, Melvin Paul; Cuaresma, Charlene; Ho, Reginald Cs; Chen, Moon S; Dang, Julie; Loui, William S

    2017-07-01

    We conducted an experimental pilot study in an oncology clinic in Honolulu, Hawai'i to determine the effect of a culturally-tailored educational DVD on cancer clinical trial participation among Filipino cancer patients. Thirty-seven patients participated in the study, with 17 randomized into the control group (ie, usual education) and 20 into the intervention group (ie, usual education plus educational DVD). Participants completed pre- and post-educational questionnaires with items asking about understanding of several cancer topics, behavioral outcomes, and attitudes regarding several treatment and physician related topics. A Fisher's exact test was conducted to explore the association between enrollment into a clinical trial and group assignment. General linear models were created to determine significant differences between study groups in post-education response scores for each questionnaire item after controlling for age, gender, education, and pre-education response scores. Two participants from the control group and three participants from the intervention group enrolled into clinical trials. Results showed no significant association between clinical trial enrollment and study group assignment ( P > .99). A significant difference was found between study groups on surety of joining the clinical trial suggested to them ( P = .013). A multilingual educational DVD to supplement clinical trial education may positively influence Filipino cancer patients to move forward with the decision to join a cancer clinical trial. However, health literacy may serve as a major barrier to actual enrollment into the particular clinical trial available to a patient.

  16. Two simple strategies (adding a logo or a senior faculty's signature) failed to improve patient participation rates in a cohort study: randomized trial

    NARCIS (Netherlands)

    van Wonderen, Karina E.; Mohrs, Jacob; Jff, Machteld I.; Bindels, Patrick J. E.; ter Riet, Gerben

    2008-01-01

    Background: Patient participation in research studies is often difficult to achieve, and efforts to increase participation rates fail frequently. Given the paucity of evidence on interventions aimed at improving patient participation, we conducted a randomized trial. Objectives: The first was to

  17. Music preferences of mechanically ventilated patients participating in a randomized controlled trial.

    Science.gov (United States)

    Heiderscheit, Annie; Breckenridge, Stephanie J; Chlan, Linda L; Savik, Kay

    2014-01-01

    Mechanical ventilation (MV) is a life-saving measure and supportive modality utilized to treat patients experiencing respiratory failure. Patients experience pain, discomfort, and anxiety as a result of being mechanically ventilated. Music listening is a non-pharmacological intervention used to manage these psychophysiological symptoms associated with mechanical ventilation. The purpose of this secondary analysis was to examine music preferences of 107 MV patients enrolled in a randomized clinical trial that implemented a patient-directed music listening protocol to help manage the psychophysiological symptom of anxiety. Music data presented includes the music genres and instrumentation patients identified as their preferred music. Genres preferred include: classical, jazz, rock, country, and oldies. Instrumentation preferred include: piano, voice, guitar, music with nature sounds, and orchestral music. Analysis of three patients' preferred music received throughout the course of the study is illustrated to demonstrate the complexity of assessing MV patients and the need for an ongoing assessment process.

  18. Music preferences of mechanically ventilated patients participating in a randomized controlled trial

    Science.gov (United States)

    Heiderscheit, Annie; Breckenridge, Stephanie J.; Chlan, Linda L.; Savik, Kay

    2014-01-01

    Mechanical ventilation (MV) is a life-saving measure and supportive modality utilized to treat patients experiencing respiratory failure. Patients experience pain, discomfort, and anxiety as a result of being mechanically ventilated. Music listening is a non-pharmacological intervention used to manage these psychophysiological symptoms associated with mechanical ventilation. The purpose of this secondary analysis was to examine music preferences of 107 MV patients enrolled in a randomized clinical trial that implemented a patient-directed music listening protocol to help manage the psychophysiological symptom of anxiety. Music data presented includes the music genres and instrumentation patients identified as their preferred music. Genres preferred include: classical, jazz, rock, country, and oldies. Instrumentation preferred include: piano, voice, guitar, music with nature sounds, and orchestral music. Analysis of three patients’ preferred music received throughout the course of the study is illustrated to demonstrate the complexity of assessing MV patients and the need for an ongoing assessment process. PMID:25574992

  19. ‘I’m still a hustler’: entrepreneurial responses to precarity by participants in phase I clinical trials

    Science.gov (United States)

    Monahan, Torin; Fisher, Jill A.

    2016-01-01

    This paper questions the implications of entrepreneurial responses to conditions of employment precarity by ‘healthy volunteers’ in phase I clinical trials in the United States. Such individuals are typically serial participants who often identify as professional volunteers and seek out drug studies as their primary source of income. Drawing on extensive qualitative research, this paper illustrates how healthy volunteers selectively import the identity of ‘hustler’ from the street environment and reposition it as connoting a set of valuable creative skills that give them a competitive edge over other participants. An entrepreneurial ethos allows them to view personal sacrifice and exposure to potentially dangerous drugs as smart investments leading to financially stable futures. These discursive moves normalize extractive, and at times dehumanizing, labour relations that offload expenses and risks to workers. PMID:27524854

  20. 'I'm still a hustler': entrepreneurial responses to precarity by participants in phase I clinical trials.

    Science.gov (United States)

    Monahan, Torin; Fisher, Jill A

    This paper questions the implications of entrepreneurial responses to conditions of employment precarity by 'healthy volunteers' in phase I clinical trials in the United States. Such individuals are typically serial participants who often identify as professional volunteers and seek out drug studies as their primary source of income. Drawing on extensive qualitative research, this paper illustrates how healthy volunteers selectively import the identity of 'hustler' from the street environment and reposition it as connoting a set of valuable creative skills that give them a competitive edge over other participants. An entrepreneurial ethos allows them to view personal sacrifice and exposure to potentially dangerous drugs as smart investments leading to financially stable futures. These discursive moves normalize extractive, and at times dehumanizing, labour relations that offload expenses and risks to workers.

  1. Factors affecting patient participation in orthopaedic trials comparing surgery to non-surgical interventions

    Directory of Open Access Journals (Sweden)

    Rajat Mittal

    2016-08-01

    Conclusion: Patient non-participation in an RCT comparing surgery to no surgery is related to concern about receiving a treatment through chance and the presence of a strong preference for a particular treatment, particularly a non-surgical one. To avoid protracted recruitment periods, investigators can increase the number of study sites and ensure personnel involved have equipoise and are trained to provide a balanced view of both treatment arms.

  2. Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.

    Science.gov (United States)

    Lee, Jeannette Y; Moore, Page; Kusek, John; Barry, Michael

    2014-01-01

    This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM). Participants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. The study was conducted at 11 clinical centers in North America. Study participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment. For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto. Blinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto.

  3. Respiratory alkalosis and primary hypocapnia in Labrador Retrievers participating in field trials in high-ambient-temperature conditions.

    Science.gov (United States)

    Steiss, Janet E; Wright, James C

    2008-10-01

    To determine whether Labrador Retrievers participating in field trials develop respiratory alkalosis and hypocapnia primarily in conditions of high ambient temperatures. 16 Labrador Retrievers. At each of 5 field trials, 5 to 10 dogs were monitored during a test (retrieval of birds over a variable distance on land [1,076 to 2,200 m]; 36 assessments); ambient temperatures ranged from 2.2 degrees to 29.4 degrees C. For each dog, rectal temperature was measured and a venous blood sample was collected in a heparinized syringe within 5 minutes of test completion. Blood samples were analyzed on site for Hct; pH; sodium, potassium, ionized calcium, glucose, lactate, bicarbonate, and total CO2 concentrations; and values of PvO2 and PvCO2. Scatterplots of each variable versus ambient temperature were reviewed. Regression analysis was used to evaluate the effect of ambient temperature ( 21 degrees C) on each variable. Compared with findings at ambient temperatures 21 degrees C; rectal temperature did not differ. Two dogs developed signs of heat stress in 1 test at an ambient temperature of 29 degrees C; their rectal temperatures were higher and PvCO2 values were lower than findings in other dogs. When running distances frequently encountered at field trials, healthy Labrador Retrievers developed hyperthermia regardless of ambient temperature. Dogs developed respiratory alkalosis and hypocapnia at ambient temperatures > 21 degrees C.

  4. Progestogens to prevent preterm birth in twin pregnancies: an individual participant data meta-analysis of randomized trials

    Directory of Open Access Journals (Sweden)

    Schuit Ewoud

    2012-03-01

    Full Text Available Abstract Background Preterm birth is the principal factor contributing to adverse outcomes in multiple pregnancies. Randomized controlled trials of progestogens to prevent preterm birth in twin pregnancies have shown no clear benefits. However, individual studies have not had sufficient power to evaluate potential benefits in women at particular high risk of early delivery (for example, women with a previous preterm birth or short cervix or to determine adverse effects for rare outcomes such as intrauterine death. Methods/design We propose an individual participant data meta-analysis of high quality randomized, double-blind, placebo-controlled trials of progestogen treatment in women with a twin pregnancy. The primary outcome will be adverse perinatal outcome (a composite measure of perinatal mortality and significant neonatal morbidity. Missing data will be imputed within each original study, before data of the individual studies are pooled. The effects of 17-hydroxyprogesterone caproate or vaginal progesterone treatment in women with twin pregnancies will be estimated by means of a random effects log-binomial model. Analyses will be adjusted for variables used in stratified randomization as appropriate. Pre-specified subgroup analysis will be performed to explore the effect of progestogen treatment in high-risk groups. Discussion Combining individual patient data from different randomized trials has potential to provide valuable, clinically useful information regarding the benefits and potential harms of progestogens in women with twin pregnancy overall and in relevant subgroups.

  5. Clinicians' views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study.

    Science.gov (United States)

    Chhoa, Celine Y; Sawyer, Alexandra; Ayers, Susan; Pushpa-Rajah, Angela; Duley, Lelia

    2017-04-26

    The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. Preterm birth can be rapid and unexpected, allowing little time for the usual consent process. Therefore, in addition to the usual procedure for written consent, a two-stage pathway for consent for use when birth was imminent was developed. The aims of this study were to explore clinicians' views and experiences of offering two consent pathways for recruitment to a randomised trial of timing of cord clamping at very preterm birth. This was a qualitative study using semi-structured interviews. Clinicians from eight hospitals in the UK who had been involved in offering consent to the Cord Pilot Trial were invited to take part in an interview. Clinicians were interviewed in person or by telephone. Interviews were analysed using inductive systematic thematic analysis. Seventeen clinicians who had either offered usual written consent only (n = 6) or both the two-stage pathway (with oral assent before the birth and written consent after the birth) and usual written consent (n = 11) were interviewed. Six themes were identified: (1) team approach to offering participation; (2) consent form as a record; (3) consent and participation as a continual process; (4) different consent pathways for different trials; (5) balance between time, information, and understanding; and (6) validity of consent. Overall, clinicians were supportive of the two-stage consent pathway. Some clinicians felt that in time-critical situations oral assent presented an advantage over the usual written consent as they provided information on a "need to know" basis. However, there was some concern about how much information should be given for oral assent, and how this is understood by women when birth is imminent. The two-stage pathway for consent developed for use in the Cord Pilot Trial when birth was imminent was acceptable to clinicians for comparable low-risk studies

  6. Deployment Repeatability

    Science.gov (United States)

    2016-04-01

    evaluating the deployment repeatability builds upon the testing or analysis of deployment kinematics (Chapter 6) and adds repetition. Introduction...material yield or failure during a test. For the purposes of this chapter, zero shift will refer to permanent changes in the structure, while reversible ...the content of other chapters in this book: Gravity Compensation (Chapter 4) and Deployment Kinematics and Dynamics (Chapter 6). Repeating the

  7. Basic fibroblast growth factor predicts cardiovascular disease occurrence in participants from the Veterans Affairs Diabetes Trial

    Directory of Open Access Journals (Sweden)

    Mark B Zimering

    2013-11-01

    Full Text Available Aim: Cardiovascular disease is a leading cause of morbidity and mortality in adults with type 2 diabetes mellitus. The aim of the present study was to test whether plasma basic fibroblast growth factor (bFGF levels predict future cardiovascular disease (CVD occurrence in adults from the Veterans Affairs Diabetes Trial. Methods: Nearly four- hundred veterans, 40 years of age or older, having a mean baseline diabetes duration of 11.4 years were recruited from outpatient clinics at six geographically distributed sites in the Veterans Affairs Diabetes Trial (VADT. Within the VADT, they were randomly assigned to intensive or standard glycemic treatment, with follow-up as much as seven and one-half years. Cardiovascular disease occurrence was examined at baseline in the patient population and during randomized treatment. Plasma bFGF was determined with a sensitive, specific two-site enzyme-linked immunoassay at the baseline study visit in all 399 subjects. Results: One hundred-five first cardiovascular events occurred in these 399 subjects. The best fit model of risk factors associated with the time to first cardiovascular disease occurrence (in the study over a seven and one-half year period had as significant predictors: prior cardiovascular event, (hazard ratio [HR] 3.378; 95% confidence intervals [CI] 3.079- 3.807; P < .0001, baseline plasma bFGF (HR 1.008; 95% CI 1.002-1.014; P =.01, age, (HR 1.027; 95% CI 1.004-1.051; P =.019, baseline plasma triglycerides, (HR 1.001; 95% CI 1.000-1.002; P =.02 and diabetes duration-treatment interaction (P =.03. Intensive glucose-lowering was associated with significantly decreased hazard ratios for CVD occurrence (0.38-0.63 in patients with known diabetes duration of 0-10 years, and non-significantly increased hazard ratios for CVD occurrence (0.82-1.78 in patients with longer diabetes duration. Conclusion: High level ofplasma basic fibroblast growth factor is a predictive biomarker of future cardiovascular

  8. Protein and calorie intakes in adult and pediatric subjects with urea cycle disorders participating in clinical trials of glycerol phenylbutyrate☆

    Science.gov (United States)

    Hook, Debra; Diaz, George A.; Lee, Brendan; Bartley, James; Longo, Nicola; Berquist, William; Le Mons, Cynthia; Rudolph-Angelich, Ingrid; Porter, Marty; Scharschmidt, Bruce F.; Mokhtarani, Masoud

    2016-01-01

    Background Little prospectively collected data are available comparing the dietary intake of urea cycle disorder (UCD) patients to UCD treatment guidelines or to healthy individuals. Objective To examine the protein and calorie intakes of UCD subjects who participated in clinical trials of glycerol phenylbutyrate (GPB) and compare these data to published UCD dietary guidelines and nutritional surveys. Design Dietary data were recorded for 45 adult and 49 pediatric UCD subjects in metabolic control during participation in clinical trials of GPB. Protein and calorie intakes were compared to UCD treatment guidelines, average nutrient intakes of a healthy US population based on the National Health and Nutrition Examination Survey (NHANES) and Recommended Daily Allowances (RDA). Results In adults, mean protein intake was higher than UCD recommendations but lower than RDA and NHANES values, while calorie intake was lower than UCD recommendations, RDA and NHANES. In pediatric subjects, prescribed protein intake was higher than UCD guidelines, similar to RDA, and lower than NHANES data for all age groups, while calorie intake was at the lower end of the recommended UCD range and close to RDA and NHANES data. In pediatric subjects height, weight, and body mass index (BMI) Z-scores were within normal range (− 2 to 2). Conclusions Pediatric patients treated with phenylbutyrate derivatives exhibited normal height and weight. Protein and calorie intakes in adult and pediatric UCD subjects differed from UCD dietary guidelines, suggesting that these guidelines may need to be reconsidered. PMID:27014577

  9. Protein and calorie intakes in adult and pediatric subjects with urea cycle disorders participating in clinical trials of glycerol phenylbutyrate.

    Science.gov (United States)

    Hook, Debra; Diaz, George A; Lee, Brendan; Bartley, James; Longo, Nicola; Berquist, William; Le Mons, Cynthia; Rudolph-Angelich, Ingrid; Porter, Marty; Scharschmidt, Bruce F; Mokhtarani, Masoud

    2016-03-01

    Little prospectively collected data are available comparing the dietary intake of urea cycle disorder (UCD) patients to UCD treatment guidelines or to healthy individuals. To examine the protein and calorie intakes of UCD subjects who participated in clinical trials of glycerol phenylbutyrate (GPB) and compare these data to published UCD dietary guidelines and nutritional surveys. Dietary data were recorded for 45 adult and 49 pediatric UCD subjects in metabolic control during participation in clinical trials of GPB. Protein and calorie intakes were compared to UCD treatment guidelines, average nutrient intakes of a healthy US population based on the National Health and Nutrition Examination Survey (NHANES) and Recommended Daily Allowances (RDA). In adults, mean protein intake was higher than UCD recommendations but lower than RDA and NHANES values, while calorie intake was lower than UCD recommendations, RDA and NHANES. In pediatric subjects, prescribed protein intake was higher than UCD guidelines, similar to RDA, and lower than NHANES data for all age groups, while calorie intake was at the lower end of the recommended UCD range and close to RDA and NHANES data. In pediatric subjects height, weight, and body mass index (BMI) Z-scores were within normal range (- 2 to 2). Pediatric patients treated with phenylbutyrate derivatives exhibited normal height and weight. Protein and calorie intakes in adult and pediatric UCD subjects differed from UCD dietary guidelines, suggesting that these guidelines may need to be reconsidered.

  10. Effect of a mass radio campaign on family behaviours and child survival in Burkina Faso: a repeated cross-sectional, cluster-randomised trial

    Directory of Open Access Journals (Sweden)

    Sophie Sarrassat, PhD

    2018-03-01

    Full Text Available Summary: Background: Media campaigns can potentially reach a large audience at relatively low cost but, to our knowledge, no randomised controlled trials have assessed their effect on a health outcome in a low-income country. We aimed to assess the effect of a radio campaign addressing family behaviours on all-cause post-neonatal under-5 child mortality in rural Burkina Faso. Methods: In this repeated cross-sectional, cluster randomised trial, clusters (distinct geographical areas in rural Burkina Faso with at least 40 000 inhabitants were selected by Development Media International based on their high radio listenership (>60% of women listening to the radio in the past week and minimum distances between radio stations to exclude population-level contamination. Clusters were randomly allocated to receive the intervention (a comprehensive radio campaign or control group (no radio media campaign. Household surveys were performed at baseline (from December, 2011, to February, 2012, midline (in November, 2013, and after 20 months of campaigning, and endline (from November, 2014, to March, 2015, after 32 months of campaigning. Primary analyses were done on an intention-to-treat basis, based on cluster-level summaries and adjusted for imbalances between groups at baseline. The primary outcome was all-cause post-neonatal under-5 child mortality. The trial was designed to detect a 20% reduction in the primary outcome with a power of 80%. Routine data from health facilities were also analysed for evidence of changes in use and these data had high statistical power. The indicators measured were new antenatal care attendances, facility deliveries, and under-5 consultations. This trial is registered with ClinicalTrial.gov, number NCT01517230. Findings: The intervention ran from March, 2012, to January, 2015. 14 clusters were selected and randomly assigned to the intervention group (n=7 or the control group (n=7. The average number of villages included per

  11. Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem.

    Science.gov (United States)

    Jefford, M; Mileshkin, L; Matthews, J; Raunow, H; O'Kane, C; Cavicchiolo, T; Brasier, H; Anderson, M; Reynolds, J

    2011-03-01

    Partially presented in poster format at the 40th and 41st Annual Meetings of the American Society of Clinical Oncology, held in 2004 in New Orleans, Louisiana and in 2005 in Orlando, Florida. We aimed to: (a) assess patient knowledge about cancer clinical trials (CCT) and satisfaction with their decision to participate, (b) determine whether satisfaction correlates with objective understanding, or other factors, and (c) identify correlates of increased understanding. A convenience sample of 100 patients were recruited. Instruments assessed quality of informed consent (QuIC), quality of life (EORTC QLQ C-30), anxiety and depression (HADS), and preferences for information and involvement in decision making. Measures were completed within 2 weeks of clinical trial enrollment. One hundred two patients (68 male) with a median age of 58.4 years (29-85) were registered in 27 of the 33 therapeutic cancer clinical trials approved for the Consent Study. Mean QuIC objective knowledge (QuIC-A) was 77.6 (/100) (95% CI, 75.7-79.4) and perceived (subjective) understanding (QuIC-B) 91.5 (95% CI, 89.6-93.3). There was low but significant correlation between QuIC-A and B (R = 0.26, p = 0.008). Satisfaction was very high. Correlation between QuIC-B and satisfaction was moderate (0.430, p < 0.001). QuIC-B, but not QuIC-A was associated with QOL scores. Preferences regarding participation in decision making and whether these preferences were achieved did not impact upon knowledge, understanding or satisfaction. Patient knowledge regarding CCT is similar to published US data, and satisfaction is high. Satisfaction correlates with perceived but not objective understanding of CCT. Strategies to further improve the consent process need to be developed.

  12. The Importance of Blood Is Infinite: Conceptions of Blood as Life Force, Rumours and Fear of Trial Participation in a Fulani Village in Rural Gambia

    NARCIS (Netherlands)

    O'Neill, S.; Dierickx, S.; Okebe, J.; Dabira, E.; Gryseels, C.; d'Alessandro, U.; Peeters Grietens, K.

    2016-01-01

    Background Clinical trials require high levels of participation and low drop-out rates to be successful. However, collecting blood samples from individuals recruited into clinical trials can be challenging when there is reticence about blood-taking. In addition to concerns regarding the feasibility

  13. A qualitative study of lung cancer risk perceptions and smoking beliefs among national lung screening trial participants.

    Science.gov (United States)

    Park, Elyse R; Streck, Joanna M; Gareen, Ilana F; Ostroff, Jamie S; Hyland, Kelly A; Rigotti, Nancy A; Pajolek, Hannah; Nichter, Mark

    2014-02-01

    The National Comprehensive Cancer Network and the American Cancer Society recently released lung screening guidelines that include smoking cessation counseling for smokers undergoing screening. Previous work indicates that smoking behaviors and risk perceptions of the National Lung Screening Trial (NLST) participants were relatively unchanged. We explored American College of Radiology Imaging Network (ACRIN)/NLST former and current smokers' risk perceptions specifically to (a) determine whether lung screening is a cue for behavior change, (b) elucidate risk perceptions for lung cancer and smoking-related diseases, and (c) explore postscreening behavioral intentions and changes. A random sample of 35 participants from 4 ACRIN sites were qualitatively interviewed 1-2 years postscreen. We used a structured interview guide based on Health Belief Model and Self-Regulation Model constructs. Content analyses were conducted with NVivo 8. Most participants endorsed high-risk perceptions for lung cancer and smoking-related diseases, but heightened concern about these risks did not appear to motivate participants to seek screening. Risk perceptions were mostly attributed to participants' heavy smoking histories; former smokers expressed greatly reduced risk. Lung cancer and smoking-related diseases were perceived as very severe although participants endorsed low worry. Current smokers had low confidence in their ability to quit, and none reported quitting following their initial screen. Lung screening did not appear to be a behavior change cue to action, and high-risk perceptions did not translate into quitting behaviors. Cognitive and emotional dissonance and avoidance strategies may deter engagement in smoking behavior change. Smoking cessation and prevention interventions during lung screening should explore risk perceptions, emotions, and quit confidence.

  14. The Adoption of Social Media to Recruit Participants for the Cool Runnings Randomized Controlled Trial in Australia.

    Science.gov (United States)

    Burgess, Jacqueline D; Kimble, Roy M; Watt, Kerrianne; Cameron, Cate M

    2017-10-24

    Using social media to recruit specific populations for research studies is gaining popularity. Given that mothers of young children are the most active on social media, and young children are the most at risk of preventable burn injuries, social media was used to recruit mothers of young children to a burn prevention intervention. The aim of this paper was to describe the social media recruitment methods used to enroll mothers of young children to the app-based burn prevention intervention Cool Runnings. Participants were recruited via paid Facebook and Instagram advertisements to a 2-group, parallel, single-blinded, randomized controlled trial (RCT). The advertisements were targeted at women 18 years and older, living in Queensland, Australia, with at least 1 child aged 5 to 12 months at the time of recruitment. Over the 30-day recruitment period from January to February 2016, Facebook and Instagram advertisements reached 65,268 people, generating 2573 link clicks, 1161 app downloads, and 498 enrolled participants to the Cool Runnings RCT. The cost per enrolled participant was Aus $13.08. Saturdays were the most effective day of the week for advertising results. The most popular time of day for enrolments was between 5 to 11 PM. This recruitment strategy campaign resulted in a broad reach of participants from regional, rural, and remote Queensland. Participants were representative of the population in regard to age and education levels. To our knowledge, this is the first use of social media recruitment for an injury prevention campaign. This recruitment method resulted in the rapid and cost-effective recruitment of participants with social, geographic, and economic diversity that were largely representative of the population. ©Jacqueline D Burgess, Roy M Kimble, Kerrianne Watt, Cate M Cameron. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.10.2017.

  15. So different, yet so similar: meta-analysis and policy modeling of willingness to participate in clinical trials among Brazilians and Indians.

    Science.gov (United States)

    Zammar, Guilherme; Meister, Henrique; Shah, Jatin; Phadtare, Amruta; Cofiel, Luciana; Pietrobon, Ricardo

    2010-12-16

    With the global expansion of clinical trials and the expectations of the rise of the emerging economies known as BRICs (Brazil, Russia, India and China), the understanding of factors that affect the willingness to participate in clinical trials of patients from those countries assumes a central role in the future of health research. We conducted a systematic review and meta-analysis (SRMA) of willingness to participate in clinical trials among Brazilian patients and then we compared it with Indian patients (with results of another SRMA previously conducted by our group) through a system dynamics model. Five studies were included in the SRMA of Brazilian patients. Our main findings are 1) the major motivation for Brazilian patients to participate in clinical trials is altruism, 2) monetary reimbursement is the least important factor motivating Brazilian patients, 3) the major barrier for Brazilian patients to not participate in clinical trials is the fear of side effects, and 4) Brazilian patients are more likely willing to participate in clinical trials than Indians. Our study provides important insights for investigators and sponsors for planning trials in Brazil (and India) in the future. Ignoring these results may lead to unnecessary fund/time spending. More studies are needed to validate our results and for better understanding of this poorly studied theme.

  16. The saving and empowering young lives in Europe (SEYLE) randomized controlled trial (RCT): methodological issues and participant characteristics.

    Science.gov (United States)

    Carli, Vladimir; Wasserman, Camilla; Wasserman, Danuta; Sarchiapone, Marco; Apter, Alan; Balazs, Judit; Bobes, Julio; Brunner, Romuald; Corcoran, Paul; Cosman, Doina; Guillemin, Francis; Haring, Christian; Kaess, Michael; Kahn, Jean Pierre; Keeley, Helen; Keresztény, Agnes; Iosue, Miriam; Mars, Ursa; Musa, George; Nemes, Bogdan; Postuvan, Vita; Reiter-Theil, Stella; Saiz, Pilar; Varnik, Peeter; Varnik, Airi; Hoven, Christina W

    2013-05-16

    Mental health problems and risk behaviours among young people are of great public health concern. Consequently, within the VII Framework Programme, the European Commission funded the Saving and Empowering Young Lives in Europe (SEYLE) project. This Randomized Controlled Trial (RCT) was conducted in eleven European countries, with Sweden as the coordinating centre, and was designed to identify an effective way to promote mental health and reduce suicidality and risk taking behaviours among adolescents. To describe the methodological and field procedures in the SEYLE RCT among adolescents, as well as to present the main characteristics of the recruited sample. Analyses were conducted to determine: 1) representativeness of study sites compared to respective national data; 2) response rate of schools and pupils, drop-out rates from baseline to 3 and 12 month follow-up, 3) comparability of samples among the four Intervention Arms; 4) properties of the standard scales employed: Beck Depression Inventory, Second Edition (BDI-II), Zung Self-Rating Anxiety Scale (Z-SAS), Strengths and Difficulties Questionnaire (SDQ), World Health Organization Well-Being Scale (WHO-5). Participants at baseline comprised 12,395 adolescents (M/F: 5,529/6,799; mean age=14.9±0.9) from Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain. At the 3 and 12 months follow up, participation rates were 87.3% and 79.4%, respectively. Demographic characteristics of participating sites were found to be reasonably representative of their respective national population. Overall response rate of schools was 67.8%. All scales utilised in the study had good to very good internal reliability, as measured by Cronbach's alpha (BDI-II: 0.864; Z-SAS: 0.805; SDQ: 0.740; WHO-5: 0.799). SEYLE achieved its objective of recruiting a large representative sample of adolescents within participating European countries. Analysis of SEYLE data will shed light on the effectiveness

  17. Changing the size of a mirror-reflected hand moderates the experience of embodiment but not proprioceptive drift: a repeated measures study on healthy human participants.

    Science.gov (United States)

    Wittkopf, Priscilla G; Lloyd, Donna M; Johnson, Mark I

    2017-06-01

    Mirror visual feedback is used for reducing pain and visually distorting the size of the reflection may improve efficacy. The findings of studies investigating size distortion are inconsistent. The influence of the size of the reflected hand on embodiment of the mirror reflection is not known. The aim of this study was to compare the effect of magnifying and minifying mirror reflections of the hand on embodiment measured using an eight-item questionnaire and on proprioceptive drift. During the experiment, participants (n = 45) placed their right hand behind a mirror and their left hand in front of a mirror. Participants watched a normal-sized, a magnified and a minified reflection of the left hand while performing synchronised finger movements for 3 min (adaptive phase). Measurements of embodiment were taken before (pre) and after (post) synchronous movements of the fingers of both hands (embodiment adaptive phase). Results revealed larger proprioceptive drift post-adaptive phase (p = 0.001). Participants agreed more strongly with questionnaire items associated with location, ownership and agency of the reflection of the hand post-adaptive phase (p embodiment of the reflection of the hand. Magnifying and minifying the reflection of the hand has little effect on proprioceptive drift, but it weakens the subjective embodiment experience. Such factors need to be taken into account in future studies using this technique, particularly when assessing mirror visual feedback for pain management.

  18. A cluster-based randomized controlled trial promoting community participation in arsenic mitigation efforts in Bangladesh.

    Science.gov (United States)

    George, Christine Marie; van Geen, Alexander; Slavkovich, Vesna; Singha, Ashit; Levy, Diane; Islam, Tariqul; Ahmed, Kazi Matin; Moon-Howard, Joyce; Tarozzi, Alessandro; Liu, Xinhua; Factor-Litvak, Pam; Graziano, Joseph

    2012-06-19

    To reduce arsenic (As) exposure, we evaluated the effectiveness of training community members to perform water arsenic (WAs) testing and provide As education compared to sending representatives from outside communities to conduct these tasks. We conducted a cluster based randomized controlled trial of 20 villages in Singair, Bangladesh. Fifty eligible respondents were randomly selected in each village. In 10 villages, a community member provided As education and WAs testing. In a second set of 10 villages an outside representative performed these tasks. Overall, 53% of respondents using As contaminated wells, relative to the Bangladesh As standard of 50 μg/L, at baseline switched after receiving the intervention. Further, when there was less than 60% arsenic contaminated wells in a village, the classification used by the Bangladeshi and UNICEF, 74% of study households in the community tester villages, and 72% of households in the outside tester villages reported switching to an As safe drinking water source. Switching was more common in the outside-tester (63%) versus community-tester villages (44%). However, after adjusting for the availability of arsenic safe drinking water sources, well switching did not differ significantly by type of As tester (Odds ratio = 0.86[95% confidence interval 0.42-1.77). At follow-up, among those using As contaminated wells who switched to safe wells, average urinary As concentrations significantly decreased. The overall intervention was effective in reducing As exposure provided there were As-safe drinking water sources available. However, there was not a significant difference observed in the ability of the community and outside testers to encourage study households to use As-safe water sources. The findings of this study suggest that As education and WAs testing programs provided by As testers, irrespective of their residence, could be used as an effective, low cost approach to reduce As exposure in many As-affected areas of

  19. A cluster-based randomized controlled trial promoting community participation in arsenic mitigation efforts in Bangladesh

    Directory of Open Access Journals (Sweden)

    George Christine

    2012-06-01

    Full Text Available Abstract Objective To reduce arsenic (As exposure, we evaluated the effectiveness of training community members to perform water arsenic (WAs testing and provide As education compared to sending representatives from outside communities to conduct these tasks. Methods We conducted a cluster based randomized controlled trial of 20 villages in Singair, Bangladesh. Fifty eligible respondents were randomly selected in each village. In 10 villages, a community member provided As education and WAs testing. In a second set of 10 villages an outside representative performed these tasks. Results Overall, 53% of respondents using As contaminated wells, relative to the Bangladesh As standard of 50 μg/L, at baseline switched after receiving the intervention. Further, when there was less than 60% arsenic contaminated wells in a village, the classification used by the Bangladeshi and UNICEF, 74% of study households in the community tester villages, and 72% of households in the outside tester villages reported switching to an As safe drinking water source . Switching was more common in the outside-tester (63% versus community-tester villages (44%. However, after adjusting for the availability of arsenic safe drinking water sources, well switching did not differ significantly by type of As tester (Odds ratio =0.86[95% confidence interval 0.42-1.77. At follow-up, among those using As contaminated wells who switched to safe wells, average urinary As concentrations significantly decreased. Conclusion The overall intervention was effective in reducing As exposure provided there were As-safe drinking water sources available. However, there was not a significant difference observed in the ability of the community and outside testers to encourage study households to use As-safe water sources. The findings of this study suggest that As education and WAs testing programs provided by As testers, irrespective of their residence, could be used as an effective, low cost

  20. Importance of Active Participation in Obesity Management Through Mobile Health Care Programs: Substudy of a Randomized Controlled Trial.

    Science.gov (United States)

    Oh, Bumjo; Yi, Ga-Hye; Han, Min Kyu; Kim, Jong Seung; Lee, Chang Hee; Cho, Belong; Kang, Hee Cheol

    2018-01-03

    Due to the prevalence of the westernized dietary pattern and lack of physical activity, the numbers of overweight or obese individuals are increasing, resulting in a growing health burden because of various related diseases. A lifestyle modification approach has additional advantages compared with pharmacological therapies or bariatric surgery. In our randomized controlled trial conducted in 2015, we successfully used a ubiquitous health care (SmartCare) service for patients with metabolic syndrome to achieve a significant weight loss effect. Various useful apps have been developed for the SmartCare Service, which involves using a mobile phone to manage chronic diseases, minimizing time and space restrictions. Many studies have demonstrated weight loss effects using a SmartCare service, but limited data are available regarding the effect of active participation in relation to weight loss. We aimed to assess the weight loss effect achieved after using the SmartCare service in terms of adherence and participation. We divided the intervention group of the previous study according to participation level, and analyzed whether there was a significant difference in the outcome. We classified participants into 3 groups according to their adherence. Within the intervention group using the SmartCare service, the active group comprised those transmitting anthropometric measurement data using a mobile phone 3 or more times per week or who had a health consultation 5 or more times during a 24-week period. The passive group comprised those who did not adhere to these levels of engagement. The control group comprised those who did not use the SmartCare service. We compared changes in body weight, body mass index (BMI), body fat percentage, waist circumference, and lipid profile among the 3 groups. We identified 422 participants and analyzed 405, excluding 17 who were missing necessary data for analysis. The active group consisted of 116 participants, compared with 80 in the

  1. Standard Versus Simplified Consent Materials for Biobank Participation: Differences in Patient Knowledge and Trial Accrual.

    Science.gov (United States)

    Garrett, Sarah B; Murphy, Marie; Wiley, James; Dohan, Daniel

    2017-12-01

    Replacing standard consent materials with simplified materials is a promising intervention to improve patient comprehension, but there is little evidence on its real-world implementation. We employed a sequential two-arm design to compare the effect of standard versus simplified consent materials on potential donors' understanding of biobank processes and their accrual to an active biobanking program. Participants were female patients of a California breast health clinic. Subjects from the simplified arm answered more items correctly ( p = .064), reported "don't know" for fewer items ( p = .077), and consented to donate to the biobank at higher rates ( p = .025) than those from the standard arm. Replacing an extant consent form with a simplified version is feasible and may benefit patient comprehension and study accrual.

  2. Effects of repeated anodal tDCS coupled with cognitive training for patients with severe traumatic brain injury: a pilot randomized controlled trial.

    Science.gov (United States)

    Leśniak, Marcin; Polanowska, Katarzyna; Seniów, Joanna; Członkowska, Anna

    2014-01-01

    To determine whether cumulative anodal transcranial direct current stimulation (A-tDCS) of the left dorsolateral prefrontal cortex (DLPFC) could enhance rehabilitation of memory and attention in patients with traumatic brain injury (TBI). Inpatient and outpatient neurorehabilitation unit. Twenty-three adult patients, 4- to 92- months post severe TBI. Participants were randomly allocated to 2 groups. The experimental group received A-tDCS (10 minutes; 1 mA; in the DLPFC), followed by rehabilitative cognitive training, daily for 15 days. Controls received A-tDCS for 25 seconds (sham condition) with the same rehabilitation. Battery of memory and attention tests, which included visual and auditory modalities. Participants were tested twice before beginning rehabilitation (to control for spontaneous recovery), after rehabilitation completion, and 4 months later. Tests scores in both groups were similar at 3 weeks before and immediately before treatment. After treatment, the experimental group exhibited larger effect sizes in 6 of 8 cognitive outcome measures, but they were not significantly different from controls. At follow-up, differences remained insignificant. In contrast to previous studies, our study did not provide sufficient evidence to support the efficacy of repeated A-tDCS for enhancing rehabilitation of memory and attention in patients after severe TBI.

  3. When is it rational to participate in a clinical trial? A game theory approach incorporating trust, regret and guilt

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2012-06-01

    Full Text Available Abstract Background Randomized controlled trials (RCTs remain an indispensable form of human experimentation as a vehicle for discovery of new treatments. However, since their inception RCTs have raised ethical concerns. The ethical tension has revolved around “duties to individuals” vs. “societal value” of RCTs. By asking current patients “to sacrifice for the benefit of future patients” we risk subjugating our duties to patients’ best interest to the utilitarian goal for the good of others. This tension creates a key dilemma: when is it rational, from the perspective of the trial patients and researchers (as societal representatives of future patients, to enroll in RCTs? Methods We employed the trust version of the prisoner’s dilemma since interaction between the patient and researcher in the setting of a clinical trial is inherently based on trust. We also took into account that the patient may have regretted his/her decision to participate in the trial, while a researcher may feel guilty because he/she abused the patient’s trust. Results We found that under typical circumstances of clinical research, most patients can be expected not to trust researchers, and most researchers can be expected to abuse the patients’ trust. The most significant factor determining trust was the success of experimental or standard treatments, respectively. The more that a researcher believes the experimental treatment will be successful, the more incentive the researcher has to abuse trust. The analysis was sensitive to the assumptions about the utilities related to success and failure of therapies that are tested in RCTs. By varying all variables in the Monte Carlo analysis we found that, on average, the researcher can be expected to honor a patient’s trust 41% of the time, while the patient is inclined to trust the researcher 69% of the time. Under assumptions of our model, enrollment into RCTs represents a rational strategy that can meet

  4. When is it rational to participate in a clinical trial? A game theory approach incorporating trust, regret and guilt.

    Science.gov (United States)

    Djulbegovic, Benjamin; Hozo, Iztok

    2012-06-22

    Randomized controlled trials (RCTs) remain an indispensable form of human experimentation as a vehicle for discovery of new treatments. However, since their inception RCTs have raised ethical concerns. The ethical tension has revolved around "duties to individuals" vs. "societal value" of RCTs. By asking current patients "to sacrifice for the benefit of future patients" we risk subjugating our duties to patients' best interest to the utilitarian goal for the good of others. This tension creates a key dilemma: when is it rational, from the perspective of the trial patients and researchers (as societal representatives of future patients), to enroll in RCTs? We employed the trust version of the prisoner's dilemma since interaction between the patient and researcher in the setting of a clinical trial is inherently based on trust. We also took into account that the patient may have regretted his/her decision to participate in the trial, while a researcher may feel guilty because he/she abused the patient's trust. We found that under typical circumstances of clinical research, most patients can be expected not to trust researchers, and most researchers can be expected to abuse the patients' trust. The most significant factor determining trust was the success of experimental or standard treatments, respectively. The more that a researcher believes the experimental treatment will be successful, the more incentive the researcher has to abuse trust. The analysis was sensitive to the assumptions about the utilities related to success and failure of therapies that are tested in RCTs. By varying all variables in the Monte Carlo analysis we found that, on average, the researcher can be expected to honor a patient's trust 41% of the time, while the patient is inclined to trust the researcher 69% of the time. Under assumptions of our model, enrollment into RCTs represents a rational strategy that can meet both patients' and researchers' interests simultaneously 19% of the time

  5. One-year health-related quality of life outcomes in weight loss trial participants: comparison of three measures

    Directory of Open Access Journals (Sweden)

    Kolotkin Ronette L

    2009-06-01

    Full Text Available Abstract Background The literature on changes in health-related quality of life (HRQOL in weight loss studies is inconsistent, and few studies use more than one type of measure. The purpose of the current study was to compare one-year changes in HRQOL as a function of weight change using three different measures: a weight-related measure (Impact of Weight on Quality of Life-Lite [IWQOL-Lite] and two generic measures (SF-36; EQ-5D. Methods Data were obtained from 926 participants (mean Body Mass Index (BMI (kg/m2 = 35.4; 84% female; mean age = 49.5 years in a placebo-controlled randomized trial for weight loss. At baseline and one-year, participants completed all three HRQOL measures. HRQOL was compared across weight change categories (≥ 5% and 0–4.9% gain, 0–4.9%, 5.0–9.9% and ≥ 10% loss, using effect sizes. Results The weight-related measure of HRQOL exhibited greater improvements with one-year weight loss than either of the generic instruments, with effect sizes ranging from 0.24 to 0.62 for 5–9.9% weight reductions and 0.44 to 0.95 for ≥ 10% reductions. IWQOL-Lite Self-Esteem also showed a small improvement with weight gain. Changes in the two generic measures of HRQOL were inconsistent with each other, and in the case of the SF-36, variable across domains. For participants gaining ≥ 5% of weight, the greatest reductions in HRQOL occurred with respect to SF-36 Mental Health, MCS, and Vitality, with effect sizes of -0.82, -0.70, and -0.63 respectively. Conclusion This study found differences between weight-related and generic measures of health-related quality of life in a one-year weight loss trial, reflecting the potential value of using more than one measure in a trial. Although weight loss was generally associated with improved IWQOL-Lite, physical SF-36 subscale and EQ-5D scores, a small amount of weight gain was associated with a slight improvement on weight-specific HRQOL and almost no change on the EQ-5D, suggesting the

  6. Interval lung cancer after a negative CT screening examination: CT findings and outcomes in National Lung Screening Trial participants

    International Nuclear Information System (INIS)

    Gierada, David S.; Pinsky, Paul F.; Duan, Fenghai; Garg, Kavita; Hart, Eric M.; Kazerooni, Ella A.; Nath, Hrudaya; Watts, Jubal R.; Aberle, Denise R.

    2017-01-01

    This study retrospectively analyses the screening CT examinations and outcomes of the National Lung Screening Trial (NLST) participants who had interval lung cancer diagnosed within 1 year after a negative CT screen and before the next annual screen. The screening CTs of all 44 participants diagnosed with interval lung cancer (cases) were matched with negative CT screens of participants who did not develop lung cancer (controls). A majority consensus process was used to classify each CT screen as positive or negative according to the NLST criteria and to estimate the likelihood that any abnormalities detected retrospectively were due to lung cancer. By retrospective review, 40/44 cases (91%) and 17/44 controls (39%) met the NLST criteria for a positive screen (P < 0.001). Cases had higher estimated likelihood of lung cancer (P < 0.001). Abnormalities included pulmonary nodules ≥4 mm (n = 16), mediastinal (n = 8) and hilar (n = 6) masses, and bronchial lesions (n = 6). Cancers were stage III or IV at diagnosis in 32/44 cases (73%); 37/44 patients (84%) died of lung cancer, compared to 225/649 (35%) for all screen-detected cancers (P < 0.0001). Most cases met the NLST criteria for a positive screen. Awareness of missed abnormalities and interpretation errors may aid lung cancer identification in CT screening. (orig.)

  7. Interval lung cancer after a negative CT screening examination: CT findings and outcomes in National Lung Screening Trial participants

    Energy Technology Data Exchange (ETDEWEB)

    Gierada, David S. [Washington University School of Medicine, Mallinckrodt Institute of Radiology, Box 8131, St. Louis, MO (United States); Pinsky, Paul F. [National Cancer Institute, Bethesda, MD (United States); Duan, Fenghai [Brown University School of Public Health, Department of Biostatistics and Center for Statistical Sciences, Providence, RI (United States); Garg, Kavita [University of Colorado School of Medicine, Mail Stop F726, Box 6510, Aurora, CO (United States); Hart, Eric M. [Northwestern University, Feinberg School of Medicine, Department of Radiology, Chicago, IL (United States); Kazerooni, Ella A. [University of Michigan Health System, Department of Radiology, Ann Arbor, MI (United States); Nath, Hrudaya; Watts, Jubal R. [University of Alabama at Birmingham School of Medicine, Department of Radiology-JTN370, Birmingham, AL (United States); Aberle, Denise R. [David Geffen School of Medicine at UCLA, Department of Radiological Sciences, Los Angeles, CA (United States)

    2017-08-15

    This study retrospectively analyses the screening CT examinations and outcomes of the National Lung Screening Trial (NLST) participants who had interval lung cancer diagnosed within 1 year after a negative CT screen and before the next annual screen. The screening CTs of all 44 participants diagnosed with interval lung cancer (cases) were matched with negative CT screens of participants who did not develop lung cancer (controls). A majority consensus process was used to classify each CT screen as positive or negative according to the NLST criteria and to estimate the likelihood that any abnormalities detected retrospectively were due to lung cancer. By retrospective review, 40/44 cases (91%) and 17/44 controls (39%) met the NLST criteria for a positive screen (P < 0.001). Cases had higher estimated likelihood of lung cancer (P < 0.001). Abnormalities included pulmonary nodules ≥4 mm (n = 16), mediastinal (n = 8) and hilar (n = 6) masses, and bronchial lesions (n = 6). Cancers were stage III or IV at diagnosis in 32/44 cases (73%); 37/44 patients (84%) died of lung cancer, compared to 225/649 (35%) for all screen-detected cancers (P < 0.0001). Most cases met the NLST criteria for a positive screen. Awareness of missed abnormalities and interpretation errors may aid lung cancer identification in CT screening. (orig.)

  8. Explaining engagement in self-monitoring among participants of the DESMOND Self-monitoring Trial: a qualitative interview study.

    Science.gov (United States)

    Eborall, Helen C; Dallosso, Helen M; McNicol, Sarah; Speight, Jane; Khunti, Kamlesh; Davies, Melanie J; Heller, Simon R

    2015-10-01

    The Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) Self-monitoring Trial reported that people with newly diagnosed type 2 diabetes attending community-based structured education and randomized to self-monitoring of blood glucose (SMBG) or urine monitoring had comparable improvements in biomedical outcomes, but differences in satisfaction with, and continued use of monitoring method, well-being and perceived threat from diabetes. To explore experiences of SMBG and urine monitoring following structured education. We specifically addressed the perceived usefulness of each monitoring method and the associated well-being. Qualitative semi-structured interviews with 18 adults with newly diagnosed type 2 diabetes participating in the DESMOND Self-monitoring Trial (SMBG, N=10; urine monitoring, N=8)~12 months into the trial. Analysis was informed by the constant comparative approach. Interviewees reported SMBG as accurate, convenient and useful. Declining use was explained by having established a pattern of managing blood glucose with less frequent monitoring or lack of feedback or encouragement from health care professionals. Many initially positive views of urine monitoring progressively changed due to perceived inaccuracy, leading some to switch to SMBG. Perceiving diabetes as less serious was attributable to lack of symptoms, treatment with diet alone and-in the urine-monitoring group-consistently negative readings. Urine monitoring also provided less visible evidence of diabetes and of the effect of behaviour on glucose. The findings highlight the importance for professionals of considering patients' preferences when using self-monitoring technologies, including how these change over time, when supporting the self-care behaviours of people with type 2 diabetes. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  9. Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Passey Megan E

    2012-08-01

    Full Text Available Abstract Background Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP offered as part of a cluster randomised controlled trial (RCT of prevention of vascular disease in primary care. Methods Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors. Results Of 301 eligible patients, 190 (63.1% were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47, physical inactivity (OR 2.90 95%CI:1.36,6.14, contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03, rural location (OR 12.50 95%CI:1.43, 109.7 and smaller practice size (1–3 GPs (OR 16.05 95%CI:2.74, 94.24. Conclusions Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs. Trial registration ACTRN

  10. Yoga, breast cancer-related lymphoedema and well-being: A descriptive report of women's participation in a clinical trial.

    Science.gov (United States)

    Loudon, Annette; Barnett, Tony; Williams, Andrew

    2017-12-01

    To describe the experiences of women taking part in a yoga intervention trial for breast cancer-related lymphoedema. Around 20% of women will experience lymphoedema as a consequence of treatment for breast cancer. Specialist lymphoedema clearing, along with self-management, remains the mainstay of therapy. Yoga, an increasingly popular complementary therapeutic practice, may provide another tool to augment self-management. A qualitative, descriptive design. Interviews were conducted with 15 women with stage one breast cancer-related lymphoedema who had completed an 8-week yoga intervention trial. The intervention consisted of a weekly teacher-led 1.5-hr yoga class and a daily home practice using a 45-min DVD. Interviews were audio-taped and transcribed. These data were then analysed using an iterative-thematic approach. Participants reported improved well-being, increased awareness of their physical body as well as improved physical, mental and social functioning. They gained from being part of the yoga group that also provided a forum for them to share their experiences. Nine women felt empowered to describe their yoga participation as a transformative journey through illness. When safe to do so, the holistic practice of yoga may augment and provide additional benefit to current self-management and treatment practices for women with breast cancer-related lymphoedema. Patients with breast cancer-related lymphoedema may seek advice and guidance from nurses and other healthcare professionals on a range of complementary therapies to help relieve symptoms and promote recovery. Patients who choose to augment their treatment of breast cancer-related lymphoedema by practicing yoga should be carefully assessed, be taught an appropriate technique by a qualified yoga teacher/therapist and its impact monitored by their yoga teacher/therapist, breast care nurse, lymphoedema therapist or treating clinician. © 2017 John Wiley & Sons Ltd.

  11. Computer tomography colonography participation and yield in patients under surveillance for 6-9 mm polyps in a population-based screening trial

    NARCIS (Netherlands)

    Tutein Nolthenius, Charlotte J.; Boellaard, Thierry N.; de Haan, Margriet C.; Nio, C. Yung; Thomeer, Maarten G. J.; Bipat, Shandra; Montauban van Swijndregt, Alexander D.; van de Vijver, Marc J.; Biermann, Katharina; Kuipers, Ernst J.; Dekker, Evelien; Stoker, Jaap

    2016-01-01

    Surveillance CT colonography (CTC) is a viable option for 6-9 mm polyps at CTC screening for colorectal cancer. We established participation and diagnostic yield of surveillance and determined overall yield of CTC screening. In an invitational CTC screening trial 82 of 982 participants harboured 6-9

  12. Repeated nebulisation of non-viral CFTR gene therapy in patients with cystic fibrosis: a randomised, double-blind, placebo-controlled, phase 2b trial.

    Science.gov (United States)

    Alton, Eric W F W; Armstrong, David K; Ashby, Deborah; Bayfield, Katie J; Bilton, Diana; Bloomfield, Emily V; Boyd, A Christopher; Brand, June; Buchan, Ruaridh; Calcedo, Roberto; Carvelli, Paula; Chan, Mario; Cheng, Seng H; Collie, D David S; Cunningham, Steve; Davidson, Heather E; Davies, Gwyneth; Davies, Jane C; Davies, Lee A; Dewar, Maria H; Doherty, Ann; Donovan, Jackie; Dwyer, Natalie S; Elgmati, Hala I; Featherstone, Rosanna F; Gavino, Jemyr; Gea-Sorli, Sabrina; Geddes, Duncan M; Gibson, James S R; Gill, Deborah R; Greening, Andrew P; Griesenbach, Uta; Hansell, David M; Harman, Katharine; Higgins, Tracy E; Hodges, Samantha L; Hyde, Stephen C; Hyndman, Laura; Innes, J Alastair; Jacob, Joseph; Jones, Nancy; Keogh, Brian F; Limberis, Maria P; Lloyd-Evans, Paul; Maclean, Alan W; Manvell, Michelle C; McCormick, Dominique; McGovern, Michael; McLachlan, Gerry; Meng, Cuixiang; Montero, M Angeles; Milligan, Hazel; Moyce, Laura J; Murray, Gordon D; Nicholson, Andrew G; Osadolor, Tina; Parra-Leiton, Javier; Porteous, David J; Pringle, Ian A; Punch, Emma K; Pytel, Kamila M; Quittner, Alexandra L; Rivellini, Gina; Saunders, Clare J; Scheule, Ronald K; Sheard, Sarah; Simmonds, Nicholas J; Smith, Keith; Smith, Stephen N; Soussi, Najwa; Soussi, Samia; Spearing, Emma J; Stevenson, Barbara J; Sumner-Jones, Stephanie G; Turkkila, Minna; Ureta, Rosa P; Waller, Michael D; Wasowicz, Marguerite Y; Wilson, James M; Wolstenholme-Hogg, Paul

    2015-09-01

    Lung delivery of plasmid DNA encoding the CFTR gene complexed with a cationic liposome is a potential treatment option for patients with cystic fibrosis. We aimed to assess the efficacy of non-viral CFTR gene therapy in patients with cystic fibrosis. We did this randomised, double-blind, placebo-controlled, phase 2b trial in two cystic fibrosis centres with patients recruited from 18 sites in the UK. Patients (aged ≥12 years) with a forced expiratory volume in 1 s (FEV1) of 50-90% predicted and any combination of CFTR mutations, were randomly assigned, via a computer-based randomisation system, to receive 5 mL of either nebulised pGM169/GL67A gene-liposome complex or 0.9% saline (placebo) every 28 days (plus or minus 5 days) for 1 year. Randomisation was stratified by % predicted FEV1 (<70 vs ≥70%), age (<18 vs ≥18 years), inclusion in the mechanistic substudy, and dosing site (London or Edinburgh). Participants and investigators were masked to treatment allocation. The primary endpoint was the relative change in % predicted FEV1. The primary analysis was per protocol. This trial is registered with ClinicalTrials.gov, number NCT01621867. Between June 12, 2012, and June 24, 2013, we randomly assigned 140 patients to receive placebo (n=62) or pGM169/GL67A (n=78), of whom 116 (83%) patients comprised the per-protocol population. We noted a significant, albeit modest, treatment effect in the pGM169/GL67A group versus placebo at 12 months' follow-up (3.7%, 95% CI 0.1-7.3; p=0.046). This outcome was associated with a stabilisation of lung function in the pGM169/GL67A group compared with a decline in the placebo group. We recorded no significant difference in treatment-attributable adverse events between groups. Monthly application of the pGM169/GL67A gene therapy formulation was associated with a significant, albeit modest, benefit in FEV1 compared with placebo at 1 year, indicating a stabilisation of lung function in the treatment group. Further improvements in

  13. Baseline and follow-up characteristics of participants and nonparticipants in a randomized clinical trial of multifactorial fall prevention in Denmark

    DEFF Research Database (Denmark)

    Vind, Ane B; Andersen, Hanne E; Pedersen, Kirsten D

    2009-01-01

    outpatient department. PARTICIPANTS: One thousand one hundred five community-dwelling adults aged 65 and older who had sustained at least one injurious fall. MEASUREMENTS: Marital status, housing tenure, income, comorbidity, hospitalization, fractures, and drug use before invitation to participate......OBJECTIVES: To address the external validity of a trial of multifactorial fall prevention through an analysis of differences between participants and nonparticipants regarding socioeconomic and morbidity variables. DESIGN: Analysis of nonresponse in a randomized clinical trial. SETTING: Geriatric...... nonparticipants of a trial of multifactorial fall prevention differed significantly from participants in terms of socioeconomic and morbidity variables and were more likely to be hospitalized or die during 6 months of follow-up. Because of the differences between the two populations, it is questionable whether...

  14. The impact of farmers’ participation in field trials in creating awareness and stimulating compliance with the World Health Organization’s farm-based multiple-barrier approach

    DEFF Research Database (Denmark)

    Amponsah, Owusu; Vigre, Håkan; Schou, Torben Wilde

    2016-01-01

    -barrier approach field trials. The results of the study show that participation in the field trials has statistically significant effects on farmers’ awareness of the farm-based multiple-barrier approach. Compliance has, however, been undermined by the farmers’ perception that the cost of compliance is more......The results of a study aimed as assessing the extent to which urban vegetable farmers’ participation in field trials can impact on their awareness and engender compliance with the World Health Organization’s farm-based multiple-barrier approach are presented in this paper. Both qualitative...... and quantitative approaches have been used in this paper. One hundred vegetable farmers and four vegetable farmers’ associations in the Kumasi Metropolis in Ghana were covered. The individual farmers were grouped into two, namely: (1) participants and (2) non-participants of the farm-based multiple...

  15. Barriers to uptake among high-risk individuals declining participation in lung cancer screening: a mixed methods analysis of the UK Lung Cancer Screening (UKLS) trial.

    Science.gov (United States)

    Ali, Noor; Lifford, Kate J; Carter, Ben; McRonald, Fiona; Yadegarfar, Ghasem; Baldwin, David R; Weller, David; Hansell, David M; Duffy, Stephen W; Field, John K; Brain, Kate

    2015-07-14

    The current study aimed to identify the barriers to participation among high-risk individuals in the UK Lung Cancer Screening (UKLS) pilot trial. The UKLS pilot trial is a randomised controlled trial of low-dose CT (LDCT) screening that has recruited high-risk people using a population approach in the Cambridge and Liverpool areas. High-risk individuals aged 50-75 years were invited to participate in UKLS. Individuals were excluded if a LDCT scan was performed within the last year, if they were unable to provide consent, or if LDCT screening was unable to be carried out due to coexisting comorbidities. Statistical associations between individual characteristics and UKLS uptake were examined using multivariable regression modelling. In those who completed a non-participation questionnaire (NPQ), thematic analysis of free-text data was undertaken to identify reasons for not taking part, with subsequent exploratory linkage of key themes to risk factors for non-uptake. Comparative data were available from 4061 high-risk individuals who consented to participate in the trial and 2756 who declined participation. Of those declining participation, 748 (27.1%) completed a NPQ. Factors associated with non-uptake included: female gender (OR=0.64, pemotional barriers. Smokers were more likely to report emotional barriers to participation. A profile of risk factors for non-participation in lung screening has emerged, with underlying reasons largely relating to practical and emotional barriers. Strategies for engaging high-risk, hard-to-reach groups are critical for the equitable uptake of a potential future lung cancer screening programme. The UKLS trial was registered with the International Standard Randomised Controlled Trial Register under the reference 78513845. 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.

  16. Perspectives of family members participating in cultural assessment of psychiatric disorders: findings from the DSM-5 International Field Trial.

    Science.gov (United States)

    Hinton, Ladson; Aggarwal, Neil; Iosif, Ana-Maria; Weiss, Mitchell; Paralikar, Vasudeo; Deshpande, Smita; Jadhav, Sushrut; Ndetei, David; Nicasio, Andel; Boiler, Marit; Lam, Peter; Avelar, Yesi; Lewis-Fernández, Roberto

    2015-02-01

    Despite the important roles families play in the lives of many individuals with mental illness across cultures, there is a dearth of data worldwide on how family members perceive the process of cultural assessment as well as to how to best include them. This study addresses this gap in our knowledge through analysis of data collected across six countries as part of a DSM-5 Field Trial of the Cultural Formulation Interview (CFI). At clinician discretion, individuals who accompanied patients to the clinic visit (i.e. patient companions) at the time the CFI was conducted were invited to participate in the cultural assessment and answer questions about their experience. The specific aims of this paper are (1) to describe patterns of participation of patient companions in the CFI across the six countries, and (2) to examine the comparative feasibility, acceptability, and clinical utility of the CFI from companion perspectives through analysis of both quantitative and qualitative data. Among the 321 patient interviews, only 86 (at four of 12 sites) included companions, all of whom were family members or other relatives. The utility, feasibility and acceptability of the CFI were rated favourably by relatives, supported by qualitative analyses of debriefing interviews. Cross-site differences in frequency of accompaniment merit further study.

  17. Iowa Gambling Task with non-clinical participants: Effects of using real + virtual cards and additional trials

    Directory of Open Access Journals (Sweden)

    William H Overman

    2013-12-01

    Full Text Available Performance on the Iowa Gambling Task (IGT in clinical populations can be interpreted only in relation to established base line performance in normal populations. As in all comparisons of assessment tools, the normal base line must reflect performance under conditions in which subjects can function at their best levels. In this review, we show that a number of variables enhance IGT performance in non-clinical participants. First, optimal performance is produced by having participants turn over real cards while viewing virtual cards on a computer screen. The use of only virtual cards results in significantly lower performance than the combination of real + virtual cards. Secondly, administration of more than 100 trials also enhances performance. When using the real/virtual card procedure, performance is shown to significantly increase from early adolescence through young adulthood. Under these conditions young (mean age 19 years and older (mean age 59 years adults perform equally. Females, as a group, score lower than males because females tend to choose cards from high-frequency-of-gain Deck B. Groups of females with high or low gonadal hormones perform equally. Concurrent tasks, e.g., presentation of aromas, decrease performance in males. Age and gender effects are discussed in terms of a dynamic between testosterone and orbital prefrontal cortex.

  18. Repeating Marx

    DEFF Research Database (Denmark)

    Fuchs, Christian; Monticelli, Lara

    2018-01-01

    This introduction sets out the context of the special issue “Karl Marx @ 200: Debating Capitalism & Perspectives for the Future of Radical Theory”, which was published on the occasion of Marx’s bicentenary on 5 May 2018. First, we give a brief overview of contemporary capitalism’s development...... and its crises. Second, we argue that it is important to repeat Marx today. Third, we reflect on lessons learned from 200 years of struggles for alternatives to capitalism. Fourth, we give an overview of the contributions in this special issue. Taken together, the contributions in this special issue show...... that Marx’s theory and politics remain key inspirations for understanding exploitation and domination in 21st-century society and for struggles that aim to overcome these phenomena and establishing a just and fair society. We need to repeat Marx today....

  19. Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT).

    Science.gov (United States)

    Durant, Raegan W; Wenzel, Jennifer A; Scarinci, Isabel C; Paterniti, Debora A; Fouad, Mona N; Hurd, Thelma C; Martin, Michelle Y

    2014-04-01

    The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority populations. Yet very little is known about the perceptions of individuals actively involved in minority recruitment to clinical trials within cancer centers. Therefore, the authors assessed the perspectives of cancer center clinical and research personnel on barriers and facilitators to minority recruitment. In total, 91 qualitative interviews were conducted at 5 US cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, research staff, and referring clinicians. All interviews were recorded and transcribed. Qualitative analyses of response data was focused on identifying prominent themes related to barriers and facilitators to minority recruitment. The perspectives of the 4 stakeholder groups were largely overlapping with some variations based on their unique roles in minority recruitment. Four prominent themes were identified: 1) racial and ethnic minorities are influenced by varying degrees of skepticism related to trial participation, 2) potential minority participants often face multilevel barriers that preclude them from being offered an opportunity to participate in a clinical trial, 3) facilitators at both the institutional and participant level potentially encourage minority recruitment, and 4) variation between internal and external trial referral procedures may limit clinical trial opportunities for racial and ethnic minorities. Multilevel approaches are needed to address barriers and optimize facilitators within cancer centers to enhance minority recruitment for cancer clinical trials. © 2014 American Cancer Society.

  20. Clinical trial management of participant recruitment, enrollment, engagement, and retention in the SMART study using a Marketing and Information Technology (MARKIT) model

    Science.gov (United States)

    Gupta, Anjali; Calfas, Karen J.; Marshall, Simon J.; Robinson, Thomas N.; Rock, Cheryl L.; Huang, Jeannie S.; Epstein-Corbin, Melanie; Servetas, Christina; Donohue, Michael C.; Norman, Gregory J.; Raab, Fredric; Merchant, Gina; Fowler, James H.; Griswold, William G.; Fogg, B.J.; Patrick, Kevin

    2015-01-01

    Advances in information technology and near ubiquity of the Internet have spawned novel modes of communication and unprecedented insights into human behavior via the digital footprint. Health behavior randomized controlled trials (RCTs), especially technology-based, can leverage these advances to improve the overall clinical trials management process and benefit from improvements at every stage, from recruitment and enrollment to engagement and retention. In this paper, we report the results for recruitment and retention of participants in the SMART study and introduce a new model for clinical trials management that is a result of interdisciplinary team science. The MARKIT model brings together best practices from information technology, marketing, and clinical research into a single framework to maximize efforts for recruitment, enrollment, engagement, and retention of participants into a RCT. These practices may have contributed to the study’s on-time recruitment that was within budget, 86% retention at 24 months, and a minimum of 57% engagement with the intervention over the 2-year RCT. Use of technology in combination with marketing practices may enable investigators to reach a larger and more diverse community of participants to take part in technology-based clinical trials, help maximize limited resources, and lead to more cost-effective and efficient clinical trial management of study participants as modes of communication evolve among the target population of participants. PMID:25866383

  1. Clinical trial management of participant recruitment, enrollment, engagement, and retention in the SMART study using a Marketing and Information Technology (MARKIT) model.

    Science.gov (United States)

    Gupta, Anjali; Calfas, Karen J; Marshall, Simon J; Robinson, Thomas N; Rock, Cheryl L; Huang, Jeannie S; Epstein-Corbin, Melanie; Servetas, Christina; Donohue, Michael C; Norman, Gregory J; Raab, Fredric; Merchant, Gina; Fowler, James H; Griswold, William G; Fogg, B J; Patrick, Kevin

    2015-05-01

    Advances in information technology and near ubiquity of the Internet have spawned novel modes of communication and unprecedented insights into human behavior via the digital footprint. Health behavior randomized controlled trials (RCTs), especially technology-based, can leverage these advances to improve the overall clinical trials management process and benefit from improvements at every stage, from recruitment and enrollment to engagement and retention. In this paper, we report the results for recruitment and retention of participants in the SMART study and introduce a new model for clinical trials management that is a result of interdisciplinary team science. The MARKIT model brings together best practices from information technology, marketing, and clinical research into a single framework to maximize efforts for recruitment, enrollment, engagement, and retention of participants into a RCT. These practices may have contributed to the study's on-time recruitment that was within budget, 86% retention at 24 months, and a minimum of 57% engagement with the intervention over the 2-year RCT. Use of technology in combination with marketing practices may enable investigators to reach a larger and more diverse community of participants to take part in technology-based clinical trials, help maximize limited resources, and lead to more cost-effective and efficient clinical trial management of study participants as modes of communication evolve among the target population of participants. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  2. Clinical Trials - Participants

    Science.gov (United States)

    ... Disorders (Pervasive Developmental Disorders) Bipolar Disorder (Manic-Depressive Illness) Borderline Personality Disorder Depression Eating Disorders Generalized Anxiety Disorder Obsessive-Compulsive Disorder (OCD) Panic Disorder Post- ...

  3. Patients' experiences of breathing retraining for asthma: a qualitative process analysis of participants in the intervention arms of the BREATHE trial.

    OpenAIRE

    Arden-Close, E; Yardley, L; Kirby, S; Thomas, M; Bruton, A

    2017-01-01

    Poor symptom control and impaired quality of life are common in adults with asthma, and breathing retraining exercises may be an effective method of self-management. This study aimed to explore the experiences of participants in the intervention arms of the BREATHE trial, which investigated the effectiveness of breathing retraining as a mode of asthma management. Sixteen people with asthma (11 women, 8 per group) who had taken part in the intervention arms of the BREATHE trial (breathing retr...

  4. Reported changes in sexual behaviour and human papillomavirus knowledge in Peruvian female sex workers following participation in a human papillomavirus vaccine trial.

    Science.gov (United States)

    Brown, B; Blas, M M; Heidari, O; Carcamo, C; Halsey, N A

    2013-07-01

    Limited data exist on the effect of clinical trial participation on sexual behavioural change. Two hundred female sex workers working in Lima, Peru received human papillomavirus (HPV) vaccine in either the standard (0, 2, 6 months) or modified (0, 3, 6 months) schedule. Participants received comprehensive screening and treatment for sexually transmitted infections (STIs), counselling on safe sex practices, education about HPV and the HPV vaccine, contraceptives (oral and condoms) and family planning at each visit. We assessed vaccine completion rates, change in sexual practices, and changes in HPV knowledge before and after participation in the vaccine trial. There were high rates of vaccine completion, 91% overall. The estimated number of reported new and total clients over a 30-day period decreased significantly (P Knowledge about HPV and HPV-related disease increased among all participants. In addition, all participants listed at least one preventive strategy during the month 7 follow-up survey.

  5. The Importance of Blood Is Infinite: Conceptions of Blood as Life Force, Rumours and Fear of Trial Participation in a Fulani Village in Rural Gambia.

    Directory of Open Access Journals (Sweden)

    Sarah O'Neill

    Full Text Available Clinical trials require high levels of participation and low drop-out rates to be successful. However, collecting blood samples from individuals recruited into clinical trials can be challenging when there is reticence about blood-taking. In addition to concerns regarding the feasibility of medical research, fears of 'blood-stealing' and 'blood-selling' have ethical implications related to cultural sensitivity and informed consent. This study explores anxieties around blood-taking during a malaria treatment trial in the Gambia.This case study is based on ethnographic research in one theoretically selected village due to the high reticence to screening for the clinical trial 'Primaquine's gametocytocidal efficacy in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine' carried out in the Gambia between 2013 and 2014. Data collection tools included in-depth interviews, participant observation, informal conversations and group discussions.In total only 176 of 411 habitants (42% in the village accepted having a bloodspot taken to screen for malaria. Although trial recruitment was initially high in the village, some families refused screening when rumours started spreading that the trial team was taking too much blood. Concerns about 'loss of blood' were equated to loss of strength and lack of good food to replenish bodily forces. Families in the study village were concerned about the weakness of their body while they had to harvest their crops at the time of recruitment for the trial.A common recommendation to prevent and avoid rumours against public health interventions and trials is the provision of full and consistent information during the consent procedure, which is assumed to lead to more accurate knowledge of the purpose of the intervention and increased trial participation. However, even when information provision is continuous, the emergence of rumours can be related to times of uncertainty and perceptions of

  6. The Importance of Blood Is Infinite: Conceptions of Blood as Life Force, Rumours and Fear of Trial Participation in a Fulani Village in Rural Gambia.

    Science.gov (United States)

    O'Neill, Sarah; Dierickx, Susan; Okebe, Joseph; Dabira, Edgard; Gryseels, Charlotte; d'Alessandro, Umberto; Peeters Grietens, Koen

    2016-01-01

    Clinical trials require high levels of participation and low drop-out rates to be successful. However, collecting blood samples from individuals recruited into clinical trials can be challenging when there is reticence about blood-taking. In addition to concerns regarding the feasibility of medical research, fears of 'blood-stealing' and 'blood-selling' have ethical implications related to cultural sensitivity and informed consent. This study explores anxieties around blood-taking during a malaria treatment trial in the Gambia. This case study is based on ethnographic research in one theoretically selected village due to the high reticence to screening for the clinical trial 'Primaquine's gametocytocidal efficacy in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine' carried out in the Gambia between 2013 and 2014. Data collection tools included in-depth interviews, participant observation, informal conversations and group discussions. In total only 176 of 411 habitants (42%) in the village accepted having a bloodspot taken to screen for malaria. Although trial recruitment was initially high in the village, some families refused screening when rumours started spreading that the trial team was taking too much blood. Concerns about 'loss of blood' were equated to loss of strength and lack of good food to replenish bodily forces. Families in the study village were concerned about the weakness of their body while they had to harvest their crops at the time of recruitment for the trial. A common recommendation to prevent and avoid rumours against public health interventions and trials is the provision of full and consistent information during the consent procedure, which is assumed to lead to more accurate knowledge of the purpose of the intervention and increased trial participation. However, even when information provision is continuous, the emergence of rumours can be related to times of uncertainty and perceptions of vulnerability, which are

  7. Cognitive behavioural therapy halves the risk of repeated suicide attempts

    DEFF Research Database (Denmark)

    Gøtzsche, Peter C; Gøtzsche, Pernille K

    2017-01-01

    is excluded, the risk ratio becomes 0.61 (0.46-0.80) and the heterogeneity in the results disappears (I(2 )= 0%). Conclusions Cognitive behavioural therapy reduces not only repeated self-harm but also repeated suicide attempts. It should be the preferred treatment for all patients with depression.......Objective To study whether cognitive behavioural therapy decreases suicide attempts in people with previous suicide attempts. Design Systematic review and meta-analysis. Setting Randomised trials that compare cognitive behavioural therapy with treatment as usual. Participants Patients who had...... engaged in any type of suicide attempt in the six months prior to trial entry resulting in presentation to clinical services. Main outcome measure Suicide attempt. Results We included ten trials, eight from Cochrane reviews and two from our updated searches (1241 patients, 219 of whom had at least one new...

  8. Regulatory T Cell Responses in Participants with Type 1 Diabetes after a Single Dose of Interleukin-2: A Non-Randomised, Open Label, Adaptive Dose-Finding Trial

    Science.gov (United States)

    Todd, John A.; Porter, Linsey; Smyth, Deborah J.; Rainbow, Daniel B.; Ferreira, Ricardo C.; Yang, Jennie H.; Bell, Charles J. M.; Schuilenburg, Helen; Challis, Ben; Clarke, Pamela; Coleman, Gillian; Dawson, Sarah; Goymer, Donna; Kennet, Jane; Brown, Judy; Greatorex, Jane; Goodfellow, Ian; Evans, Mark; Mander, Adrian P.; Bond, Simon; Wicker, Linda S.

    2016-01-01

    Background Interleukin-2 (IL-2) has an essential role in the expansion and function of CD4+ regulatory T cells (Tregs). Tregs reduce tissue damage by limiting the immune response following infection and regulate autoreactive CD4+ effector T cells (Teffs) to prevent autoimmune diseases, such as type 1 diabetes (T1D). Genetic susceptibility to T1D causes alterations in the IL-2 pathway, a finding that supports Tregs as a cellular therapeutic target. Aldesleukin (Proleukin; recombinant human IL-2), which is administered at high doses to activate the immune system in cancer immunotherapy, is now being repositioned to treat inflammatory and autoimmune disorders at lower doses by targeting Tregs. Methods and Findings To define the aldesleukin dose response for Tregs and to find doses that increase Tregs physiologically for treatment of T1D, a statistical and systematic approach was taken by analysing the pharmacokinetics and pharmacodynamics of single doses of subcutaneous aldesleukin in the Adaptive Study of IL-2 Dose on Regulatory T Cells in Type 1 Diabetes (DILT1D), a single centre, non-randomised, open label, adaptive dose-finding trial with 40 adult participants with recently diagnosed T1D. The primary endpoint was the maximum percentage increase in Tregs (defined as CD3+CD4+CD25highCD127low) from the baseline frequency in each participant measured over the 7 d following treatment. There was an initial learning phase with five pairs of participants, each pair receiving one of five pre-assigned single doses from 0.04 × 106 to 1.5 × 106 IU/m2, in order to model the dose-response curve. Results from each participant were then incorporated into interim statistical modelling to target the two doses most likely to induce 10% and 20% increases in Treg frequencies. Primary analysis of the evaluable population (n = 39) found that the optimal doses of aldesleukin to induce 10% and 20% increases in Tregs were 0.101 × 106 IU/m2 (standard error [SE] = 0.078, 95% CI = −0

  9. Primary Care Provider-Delivered Smoking Cessation Interventions and Smoking Cessation Among Participants in the National Lung Screening Trial.

    Science.gov (United States)

    Park, Elyse R; Gareen, Ilana F; Japuntich, Sandra; Lennes, Inga; Hyland, Kelly; DeMello, Sarah; Sicks, JoRean D; Rigotti, Nancy A

    2015-09-01

    The National Lung Screening Trial (NLST) found a reduction in lung cancer mortality among participants screened with low-dose computed tomography vs chest radiography. In February 2015, Medicare announced its decision to cover annual lung screening for patients with a significant smoking history. These guidelines promote smoking cessation treatment as an adjunct to screening, but the frequency and effectiveness of clinician-delivered smoking cessation interventions delivered after lung screening are unknown. To determine the association between the reported clinician-delivered 5As (ask, advise, assess, assist [talk about quitting or recommend stop-smoking medications or recommend counseling], and arrange follow-up) after lung screening and smoking behavior changes. A matched case-control study (cases were quitters and controls were continued smokers) of 3336 NLST participants who were smokers at enrollment examined participants' rates and patterns of 5A delivery after a lung screen and reported smoking cessation behaviors. Prevalence of the clinician-delivered 5As and associated smoking cessation after lung screening. Delivery of the 5As 1 year after screening were as follows: ask, 77.2%; advise, 75.6%; assess, 63.4%; assist, 56.4%; and arrange follow-up, 10.4%. Receipt of ask, advise, and assess was not significantly associated with quitting in multivariate models that adjusted for sociodemographic characteristics, medical history, screening results, nicotine dependence, and motivation to quit. Assist was associated with a 40% increase in the odds of quitting (odds ratio, 1.40; 95% CI, 1.21-1.63), and arrange was associated with a 46% increase in the odds of quitting (odds ratio, 1.46; 95% CI, 1.19-1.79). Assist and arrange follow-up delivered by primary care providers to smokers who were participating in the NLST were associated with increased quitting; less intensive interventions (ask, advise, and assess) were not. However, rates of assist and arrange

  10. Effects on Symptoms of Agitation and Depression in Persons With Dementia Participating in Robot-Assisted Activity: A Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebæk, Camilla

    2015-10-01

    To examine effects on symptoms of agitation and depression in nursing home residents with moderate to severe dementia participating in a robot-assisted group activity with the robot seal Paro. A cluster-randomized controlled trial. Ten nursing home units were randomized to either robot-assisted intervention or a control group with treatment as usual during 3 intervention periods from 2013 to 2014. Ten adapted units in nursing homes in 3 counties in eastern Norway. Sixty residents (67% women, age range 62-95 years) in adapted nursing home units with a dementia diagnosis or cognitive impairment (Mini-Mental State Examination score lower than 25/30). Group sessions with Paro took place in a separate room at nursing homes for 30 minutes twice a week over the course of 12 weeks. Local nurses were trained to conduct the intervention. Participants were scored on baseline measures (T0) assessing cognitive status, regular medication, agitation (BARS), and depression (CSDD). The data collection was repeated at end of intervention (T1) and at follow-up (3 months after end of intervention) (T2). Mixed models were used to test treatment and time effects. Statistically significant differences in changes were found on agitation and depression between groups from T0 to T2. Although the symptoms of the intervention group declined, the control group's symptoms developed in the opposite direction. Agitation showed an effect estimate of -5.51, CI 0.06-10.97, P = .048, and depression -3.88, CI 0.43-7.33, P = .028. There were no significant differences in changes on either agitation or depression between groups from T0 to T1. This study found a long-term effect on depression and agitation by using Paro in activity groups for elderly with dementia in nursing homes. Paro might be a suitable nonpharmacological treatment for neuropsychiatric symptoms and should be considered as a useful tool in clinical practice. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care

  11. Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

    Science.gov (United States)

    Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

    2017-02-01

    This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

  12. Psychiatric treatment following participation in the CapOpus randomized trial for patients with comorbid cannabis use disorder and psychosis

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten Rygaard; Orlovska, Sonja; Fohlmann, Allan

    2013-01-01

    Randomized trials targeting cannabis use disorders in patients with psychosis have generally been unsuccessful. One of the largest such trials was the CapOpus trial, which had an impact on the number of monthly joints used, but not on the number of days with cannabis use or positive or negative...

  13. Effect of Repeated Food Morsel Splitting on Jaw Muscle Control

    DEFF Research Database (Denmark)

    A, Kumar; Svensson, Krister G; Baad-Hansen, Lene

    2014-01-01

    Mastication is a complex motor task often initiated by splitting of the food morsel between the anterior teeth. Training of complex motor tasks has consistently been shown to trigger neuroplastic changes in corticomotor control and optimization of muscle function. It is not known if training...... and repeated food morsel splitting lead to changes in jaw muscle function. Objective: To investigate if repeated splitting of food morsels in participants with natural dentition changes the force and jaw muscle electromyographic (EMG) activity. Methods: Twenty healthy volunteers (mean age = 26.2 ± 3.9 years......) participated in a single one-hour session divided into six series. Each series consisted of ten trials of a standardized behavioral task (total of 60 trials). The behavioral task was to hold and split a food morsel (8 mm, 180 mg placebo tablet) placed on a bite force transducer with the anterior teeth...

  14. Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial.

    Science.gov (United States)

    Passey, Megan E; Laws, Rachel A; Jayasinghe, Upali W; Fanaian, Mahnaz; McKenzie, Suzanne; Powell-Davies, Gawaine; Lyle, David; Harris, Mark F

    2012-08-03

    Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP) offered as part of a cluster randomised controlled trial (RCT) of prevention of vascular disease in primary care. Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors. Of 301 eligible patients, 190 (63.1%) were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47), physical inactivity (OR 2.90 95%CI:1.36,6.14), contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03), rural location (OR 12.50 95%CI:1.43, 109.7) and smaller practice size (1-3 GPs) (OR 16.05 95%CI:2.74, 94.24). Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs. ACTRN12607000423415.

  15. Baseline participant characteristics and risk for dropout from ten obesity randomized controlled trials: a pooled analysis of individual level data.

    Science.gov (United States)

    Kaiser, Kathryn A; Affuso, Olivia; Desmond, Renee; Allison, David B

    Understanding participant demographic characteristics that inform the optimal design of obesity RCTs have been examined in few studies. The objective of this study was to investigate the association of individual participant characteristics and dropout rates (DORs) in obesity randomized controlled trials (RCT) by pooling data from several publicly available datasets for analyses. We comprehensively characterize DORs and patterns in obesity RCTs at the individual study level, and describe how such rates and patterns vary as a function of individual-level characteristics. We obtained and analyzed nine publicly-available, obesity RCT datasets that examined weight loss or weight gain prevention as a primary or secondary endpoint. Four risk factors for dropout were examined by Cox proportional hazards including sex, age, baseline BMI, and race/ethnicity. The individual study data were pooled in the final analyses with a random effect for study, and HR and 95% CIs were computed. Results of the multivariate analysis indicated that the risk of dropout was significantly higher for females compared to males (HR= 1.24, 95% CI = 1.05, 1.46). Hispanics and Non-Hispanic blacks had a significantly higher dropout rate compared to non-Hispanic whites (HR= 1.62, 95% CI = 1.37, 1.91; HR= 1.22, 95% CI = 1.11, 1.35, respectively). There was a significantly increased risk of dropout associated with advancing age (HR= 1.02, 95% CI = 1.01, 1.02) and increasing BMI (HR= 1.03, 95% CI = 1.03, 1.04). As more studies may focus on special populations, researchers designing obesity RCTs may wish to oversample in certain demographic groups if attempting to match comparison groups based on generalized estimates of expected dropout rates, or otherwise adjust a priori power estimates. Understanding true reasons for dropout may require additional methods of data gathering not generally employed in obesity RCTs, e.g. time on treatment.

  16. Computerised training improves cognitive performance in chronic pain: a participant-blinded randomised active-controlled trial with remote supervision.

    Science.gov (United States)

    Baker, Katharine S; Georgiou-Karistianis, Nellie; Lampit, Amit; Valenzuela, Michael; Gibson, Stephen J; Giummarra, Melita J

    2018-04-01

    Chronic pain is associated with reduced efficiency of cognitive performance, and few studies have investigated methods of remediation. We trialled a computerised cognitive training protocol to determine whether it could attenuate cognitive difficulties in a chronic pain sample. Thirty-nine adults with chronic pain (mean age = 43.3, 61.5% females) were randomised to an 8-week online course (3 sessions/week from home) of game-like cognitive training exercises, or an active control involving watching documentary videos. Participants received weekly supervision by video call. Primary outcomes were a global neurocognitive composite (tests of attention, speed, and executive function) and self-reported cognition. Secondary outcomes were pain (intensity; interference), mood symptoms (depression; anxiety), and coping with pain (catastrophising; self-efficacy). Thirty participants (15 training and 15 control) completed the trial. Mixed model intention-to-treat analyses revealed significant effects of training on the global neurocognitive composite (net effect size [ES] = 0.43, P = 0.017), driven by improved executive function performance (attention switching and working memory). The control group reported improvement in pain intensity (net ES = 0.65, P = 0.022). Both groups reported subjective improvements in cognition (ES = 0.28, P = 0.033) and catastrophising (ES = 0.55, P = 0.006). Depression, anxiety, self-efficacy, and pain interference showed no change in either group. This study provides preliminary evidence that supervised cognitive training may be a viable method for enhancing cognitive skills in persons with chronic pain, but transfer to functional and clinical outcomes remains to be demonstrated. Active control results suggest that activities perceived as relaxing or enjoyable contribute to improved perception of well-being. Weekly contact was pivotal to successful program completion.

  17. Efficacy of Folic Acid Supplementation in Autistic Children Participating in Structured Teaching: An Open-Label Trial.

    Science.gov (United States)

    Sun, Caihong; Zou, Mingyang; Zhao, Dong; Xia, Wei; Wu, Lijie

    2016-06-07

    Autism spectrum disorders (ASD) are recognized as a major public health issue. Here, we evaluated the effects of folic acid intervention on methylation cycles and oxidative stress in autistic children enrolled in structured teaching. Sixty-six autistic children enrolled in this open-label trial and participated in three months of structured teaching. Forty-four children were treated with 400 μg folic acid (two times/daily) for a period of three months during their structured teaching (intervention group), while the remaining 22 children were not given any supplement for the duration of the study (control group). The Autism Treatment Evaluation Checklist (ATEC) and Psychoeducational Profile-third edition (PEP-3) were measured at the beginning and end of the treatment period. Folic acid, homocysteine, and glutathione metabolism in plasma were measured before and after treatment in 29 autistic children randomly selected from the intervention group and were compared with 29 age-matched unaffected children (typical developmental group). The results illustrated folic acid intervention improved autism symptoms towards sociability, cognitive verbal/preverbal, receptive language, and affective expression and communication. Furthermore, this treatment also improved the concentrations of folic acid, homocysteine, and normalized glutathione redox metabolism. Folic acid supplementation may have a certain role in the treatment of children with autism.

  18. Does it matter if clinicians recruiting for a trial don't understand what the trial is really about? Qualitative study of surgeons' experiences of participation in a pragmatic multi-centre RCT

    Directory of Open Access Journals (Sweden)

    Snowdon Claire

    2007-01-01

    Full Text Available Abstract Background Qualitative methods are increasingly used to study the process of clinical trials and patients understanding of the rationale for trials, randomisation and reasons for taking part or refusing. Patients' understandings are inevitably influenced by the recruiting clinician's understanding of the trial, yet relatively little qualitative work has explored clinicians' perceptions and understandings of trials. This study interviewed surgeons shortly after the multi-centre, pragmatic RCT in which they had participated had been completed. Methods We used in-depth interviews with surgeons who participated in the Spine Stabilisation Trial (a pragmatic RCT to explore their understanding of the trial purpose and how this understanding had influenced their recruitment procedures and interpretation of the results. A purposive sample of eleven participating surgeons was chosen from 8 of the 15 UK trial centres. Results Although the surgeons thought that the trial was addressing an important question there was little agreement about what this question was: although it was a trial of 'equivalent' treatments, some thought that it was a trial of surgery, others a trial of rehabilitation and others that it was exploring what to do with patients in whom all other treatment options had been unsuccessful. The surgeons we interviewed were not aware of the rationale for the pragmatic inclusion criteria and nearly all were completely baffled about the meaning of 'equipoise'. Misunderstandings about the entry criteria were an important source of confusion about the results and led to reluctance to apply the results to their own practice. Conclusion The study suggests several lessons for the conduct of future multi-centre trials. Recruiting surgeons (and other clinicians may not be familiar with the rationale for pragmatic designs and may need to be regularly reminded about the purpose during the study. Reassurance may be necessary that a pragmatic

  19. Features predicting weight loss in overweight or obese participants in a web-based intervention: randomized trial.

    Science.gov (United States)

    Brindal, Emily; Freyne, Jill; Saunders, Ian; Berkovsky, Shlomo; Smith, Greg; Noakes, Manny

    2012-12-12

    Obesity remains a serious issue in many countries. Web-based programs offer good potential for delivery of weight loss programs. Yet, many Internet-delivered weight loss studies include support from medical or nutritional experts, and relatively little is known about purely web-based weight loss programs. To determine whether supportive features and personalization in a 12-week web-based lifestyle intervention with no in-person professional contact affect retention and weight loss. We assessed the effect of different features of a web-based weight loss intervention using a 12-week repeated-measures randomized parallel design. We developed 7 sites representing 3 functional groups. A national mass media promotion was used to attract overweight/obese Australian adults (based on body mass index [BMI] calculated from self-reported heights and weights). Eligible respondents (n = 8112) were randomly allocated to one of 3 functional groups: information-based (n = 183), supportive (n = 3994), or personalized-supportive (n = 3935). Both supportive sites included tools, such as a weight tracker, meal planner, and social networking platform. The personalized-supportive site included a meal planner that offered recommendations that were personalized using an algorithm based on a user's preferences for certain foods. Dietary and activity information were constant across sites, based on an existing and tested 12-week weight loss program (the Total Wellbeing Diet). Before and/or after the intervention, participants completed demographic (including self-reported weight), behavioral, and evaluation questionnaires online. Usage of the website and features was objectively recorded. All screening and data collection procedures were performed online with no face-to-face contact. Across all 3 groups, attrition was high at around 40% in the first week and 20% of the remaining participants each week. Retention was higher for the supportive sites compared to the information-based site only

  20. Strategies of persuasion in offers to participate in cancer clinical trials I: Topic placement and topic framing.

    Science.gov (United States)

    Barton, Ellen; Eggly, Susan; Winckles, Andrew; Albrecht, Terrance L

    2014-01-01

    Clinical trials are the gold standard in medical research evaluating new treatments in cancer care; however, in the United States, too few patients enroll in trials, especially patients from minority groups. Offering patients the option of a clinical trial is an ethically-charged communicative event for oncologists. One particularly vexed ethical issue is the use of persuasion in trial offers. Based on a corpus of 22 oncology encounters with Caucasian-American (n = 11) and African-American (n = 11) patients, this discourse analysis describes oncologists' use of two persuasive strategies related to the linguistic structure of trial offers: topic placement and topic framing. Findings are presented in total and by patient race, and discussed in terms of whether these strategies may constitute ethical or unethical persuasion, particularly with respect to the ethical issue of undue influence and the social issue of underrepresentation of minorities in cancer clinical trials.

  1. A randomised controlled trial to improve general practitioners' services in cancer rehabilitation: Effects on general practitioners' proactivity and on patients' participation in rehabilitation activities

    DEFF Research Database (Denmark)

    Bergholdt, SH; Søndergaard, J; Larsen, PV

    2013-01-01

    by their GP reported by the patients and GPs, respectively, and patients' participation in rehabilitation activities. Methods. Cluster randomised controlled trial. All general practices in Denmark were randomised to an intervention group or to a control group (usual procedures). Patients were subsequently...

  2. Screening for and subsequent participation in a trial for depression and anxiety in people with type 2 diabetes treated in primary care: Who do we reach?

    NARCIS (Netherlands)

    Stoop, C.H.; Nefs, G.M.; Pop, V.J.M.; Pouwer, F.

    2017-01-01

    AIMS: This study investigated (factors related to) (a) the response to a screening procedure for depression and anxiety in people with type 2 diabetes in primary care, and (b) participation in a subsequent randomised controlled trial targeting depressive or anxiety symptoms. METHODS: People with

  3. Screening for and subsequent participation in a trial for depression and anxiety in people with type 2 diabetes treated in primary care : Who do we reach?

    NARCIS (Netherlands)

    Stoop, C.H.; Nefs, G.M.; Pop, V.J.M.; Pouwer, François

    2017-01-01

    Aims: This study investigated (factors related to) (a) the response to a screening procedure for depression and anxiety in people with type 2 diabetes in primary care, and (b) participation in a subsequent randomised controlled trial targeting depressive or anxiety symptoms. Methods: People with

  4. Clinical trials of medicinal cannabis for appetite-related symptoms from advanced cancer: a survey of preferences, attitudes and beliefs among patients willing to consider participation.

    Science.gov (United States)

    Luckett, T; Phillips, J; Lintzeris, N; Allsop, D; Lee, J; Solowij, N; Martin, J; Lam, L; Aggarwal, R; McCaffrey, N; Currow, D; Chye, R; Lovell, M; McGregor, I; Agar, M

    2016-11-01

    Australian clinical trials are planned to evaluate medicinal cannabis in a range of clinical contexts. To explore the preferences, attitudes and beliefs of patients eligible and willing to consider participation in a clinical trial of medicinal cannabis for poor appetite and appetite-related symptoms from advanced cancer. A cross-sectional anonymous survey was administered from July to December 2015 online and in eight adult outpatient palliative care and/or cancer services. Respondents were eligible if they were ≥18 years, had advanced cancer and poor appetite/taste problems/weight loss and might consider participating in a medicinal cannabis trial. Survey items focused on medicinal rather than recreational cannabis use and did not specify botanical or pharmaceutical products. Items asked about previous medicinal cannabis use and preferences for delivery route and invited comments and concerns. There were 204 survey respondents, of whom 26 (13%) reported prior medicinal cannabis use. Tablets/capsules were the preferred delivery mode (n = 144, 71%), followed by mouth spray (n = 84, 42%) and vaporiser (n = 83, 41%). Explanations for preferences (n = 134) most commonly cited convenience (n = 66; 49%). A total of 82% (n = 168) of respondents indicated that they had no trial-related concerns, but a small number volunteered concerns about adverse effects (n = 14) or wanted more information/advice (n = 8). Six respondents volunteered a belief that cannabis might cure cancer, while two wanted assurance of efficacy before participating in a trial. Justification of modes other than tablets/capsules and variable understanding about cannabis and trials will need addressing in trial-related information to optimise recruitment and ensure that consent is properly informed. © 2016 Royal Australasian College of Physicians.

  5. Clinical Trial Participation and Time to Treatment Among Adolescents and Young Adults With Cancer: Does Age at Diagnosis or Insurance Make a Difference?

    Science.gov (United States)

    Parsons, Helen M.; Harlan, Linda C.; Seibel, Nita L.; Stevens, Jennifer L.; Keegan, Theresa H.M.

    2011-01-01

    Purpose Because adolescent and young adult (AYA) patients with cancer have experienced variable improvement in survival over the past two decades, enhancing the quality and timeliness of cancer care in this population has emerged as a priority area. To identify current trends in AYA care, we examined patterns of clinical trial participation, time to treatment, and provider characteristics in a population-based sample of AYA patients with cancer. Methods Using the National Cancer Institute Patterns of Care Study, we used multivariate logistic regression to evaluate demographic and provider characteristics associated with clinical trial enrollment and time to treatment among 1,358 AYA patients with cancer (age 15 to 39 years) identified through the Surveillance, Epidemiology, and End Results Program. Results In our study, 14% of patients age 15 to 39 years had enrolled onto a clinical trial; participation varied by type of cancer, with the highest participation in those diagnosed with acute lymphoblastic leukemia (37%) and sarcoma (32%). Multivariate analyses demonstrated that uninsured, older patients and those treated by nonpediatric oncologists were less likely to enroll onto clinical trials. Median time from pathologic confirmation to first treatment was 3 days, but this varied by race/ethnicity and cancer site. In multivariate analyses, advanced cancer stage and outpatient treatment alone were associated with longer time from pathologic confirmation to treatment. Conclusion Our study identified factors associated with low clinical trial participation in AYA patients with cancer. These findings support the continued need to improve access to clinical trials and innovative treatments for this population, which may ultimately translate into improved survival. PMID:21931022

  6. Pregnancy incidence and risk factors among women participating in vaginal microbicide trials for HIV prevention: systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Alfred Musekiwa

    Full Text Available INTRODUCTION: Pregnancy is contraindicated in vaginal microbicide trials for the prevention of HIV infection in women due to the unknown maternal and fetal safety of the microbicides. Women who become pregnant are taken off the microbicide during pregnancy period but this result in reduction of the power of the trials. Strategies to reduce the pregnancy rates require an understanding of the incidence and associated risk factors of pregnancy in microbicide trials. This systematic review estimates the overall incidence rate of pregnancy in microbicide trials and describes the associated risk factors. METHODS: A comprehensive literature search was carried out to identify eligible studies from electronic databases and other sources. Two review authors independently selected studies and extracted relevant data from included studies. Meta-analysis of incidence rates of pregnancy was carried out and risk factors of pregnancy were reported narratively. RESULTS: Fifteen studies reporting data from 10 microbicide trials (N=27,384 participants were included. A total of 4,107 participants (15.0% fell pregnant and a meta-analysis of incidence rates of pregnancy from 8 microbicide trials (N=25,551 yielded an overall incidence rate of 23.37 (95%CI: 17.78 to 28.96 pregnancies per 100 woman-years. However, significant heterogeneity was detected. Hormonal injectable, intra-uterine device (IUD or implants or sterilization, older age, more years of education and condom use were associated with lower pregnancy. On the other hand, living with a man, history of pregnancy, self and partner desire for future baby, oral contraceptive use, increased number of unprotected sexual acts and inconsistent use of condoms were associated with higher pregnancy. CONCLUSIONS: The incidence rate of pregnancy in microbicide trials is high and strategies for its reduction are urgently required in order to improve the sample size and power of these trials.

  7. Effects of primary caregiver participation in vestibular rehabilitation for unilateral neglect patients with right hemispheric stroke: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dai CY

    2013-04-01

    Full Text Available Chin-Ying Dai,1,2 Yu-Hui Huang,3,4 Li-Wei Chou,5,6 Shiao-Chi Wu,7 Ray-Yau Wang,8 Li-Chan Lin9 1School of Nursing, National Yang Ming University, Taipei, Taiwan; 2Department of Nursing, Central Taiwan University of Science and Technology, Taichung, Taiwan; 3Department of Physical Medicine and Rehabilitation, Chung Shan Medical University Hospital, Taichung, Taiwan; 4School of Medicine, Chung Shan Medical University, Taichung, Taiwan; 5Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung, Taiwan; 6School of Chinese Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan; 7Institute of Health and Welfare Policy, National Yang-Ming University, Taipei, Taiwan; 8Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan; 9Institute of Clinical and Community Health Nursing, National Yang-Ming University, Taipei, Taiwan, Republic of China Introduction: The current study aims to investigate the effects of primary caregiver participation in vestibular rehabilitation (VR on improving the measures of neglect, activities of daily living (ADL, balance, and falls of unilateral neglect (UN patients. Methods: This study is a single-blind randomized controlled trial. Both experimental (n = 24 and control groups (n = 24 received conventional rehabilitation. The experimental group undertook VR for a month. During the first and second weeks, a registered nurse trained the experimental group in VR. The primary caregivers in the experimental group supervised and guided their patients in VR during the third and fourth weeks. The outcome measures were neglect, ADL, balance, and falls. Results: The two groups of UN patients showed a significant improvement in neglect, ADL, and balance over time. Based on the generalized estimating equations model, an interaction was observed between groups and times. Significant interactions were observed between the VR group

  8. Baseline participant characteristics and risk for dropout from ten obesity randomized controlled trials: a pooled analysis of individual level data

    Directory of Open Access Journals (Sweden)

    Kathryn Ann Kaiser

    2014-12-01

    Full Text Available Introduction: Understanding participant demographic characteristics that inform the optimal design of obesity RCTs have been examined in few studies. The objective of this study was to investigate the association of individual participant characteristics and dropout rates (DORs in obesity randomized controlled trials (RCT by pooling data from several publicly available datasets for analyses. We comprehensively characterize DORs and patterns in obesity RCTs at the individual study level, and describe how such rates and patterns vary as a function of individual-level characteristics. Methods: We obtained and analyzed nine publicly-available, obesity RCT datasets that examined weight loss or weight gain prevention as a primary or secondary endpoint. Four risk factors for dropout were examined by Cox proportional hazards including sex, age, baseline BMI, and race/ethnicity. The individual study data were pooled in the final analyses with a random effect for study, and HR and 95% CIs were computed. Results: Results of the multivariate analysis indicated that the risk of dropout was significantly higher for females compared to males (HR= 1.24, 95% CI = 1.05, 1.46. Hispanics and Non-Hispanic blacks had a significantly higher dropout rate compared to non-Hispanic whites (HR= 1.62, 95% CI = 1.37, 1.91; HR= 1.22, 95% CI = 1.11, 1.35, respectively. There was a significantly increased risk of dropout associated with advancing age (HR= 1.02, 95% CI = 1.01, 1.02 and increasing BMI (HR= 1.03, 95% CI = 1.03, 1.04. Conclusion/Significance: As more studies may focus on special populations, researchers designing obesity RCTs may wish to oversample in certain demographic groups if attempting to match comparison groups based on generalized estimates of expected dropout rates, or otherwise adjust a priori power estimates. Understanding true reasons for dropout may require additional methods of data gathering not generally employed in obesity RCTs, e.g. time on

  9. The role of lymphadenectomy in endometrial cancer: was the ASTEC trial doomed by design and are we destined to repeat that mistake?

    Science.gov (United States)

    Naumann, R Wendel

    2012-07-01

    This study examines the design of previous and future trials of lymph node dissection in endometrial cancer. Data from previous trials were used to construct a decision analysis modeling the risk of lymphatic spread and the effects of treatment on patients with endometrial cancer. This model was then applied to previous trials as well as other future trial designs that might be used to address this subject. Comparing the predicted and actual results in the ASTEC trial, the model closely mimics the survival results with and without lymph node dissection for the low and high risk groups. The model suggests a survival difference of less than 2% between the experimental and control arms of the ASTEC trial under all circumstances. Sensitivity analyses reveal that these conclusions are robust. Future trial designs were also modeled with hysterectomy only, hysterectomy with radiation in intermediate risk patients, and staging with radiation only with node positive patients. Predicted outcomes for these approaches yield survival rates of 88%, 90%, and 93% in clinical stage I patients who have a risk of pelvic node involvement of approximately 7%. These estimates were 78%, 82%, and 89% in intermediate risk patients who have a risk of nodal spread of approximately 15%. This model accurately predicts the outcome of previous trials and demonstrates that even if lymph node dissection was therapeutic, these trials would have been negative due to study design. Furthermore, future trial designs that are being considered would need to be conducted in high-intermediate risk patients to detect any difference. Copyright © 2012 Elsevier Inc. All rights reserved.

  10. Neck-cooling improves repeated sprint performance in the heat

    Directory of Open Access Journals (Sweden)

    Caroline eSunderland

    2015-11-01

    Full Text Available The present study evaluated the effect of neck-cooling during exercise on repeated sprint ability in a hot environment. Seven team-sport playing males completed two experimental trials involving repeated sprint exercise (5 x 6 s before and after two 45 min bouts of a football specific intermittent treadmill protocol in the heat (33.0  0.2 ºC; 53 ± 2% relative humidity. Participants wore a neck-cooling collar in one of the trials (CC. Mean power output and peak power output declined over time in both trials but were higher in CC (540 ± 99 v 507 ± 122W, d = 0.32; 719 ± 158 v 680 ± 182 W, d = 0.24 respectively. The improved power output was particularly pronounced (d = 0.51 – 0.88 after the 2nd 45 min bout but the CC had no effect on % fatigue. The collar lowered neck temperature and the thermal sensation of the neck (P 0.05. There were no trial differences but interaction effects were demonstrated for prolactin concentration and rating of perceived exertion (RPE. Prolactin concentration was initially higher in the collar cold trial and then was lower from 45 minutes onwards (interaction trial x time P=0.04. RPE was lower during the football intermittent treadmill protocol in the collar cold trial (interaction trial x time P = 0.01. Neck-cooling during exercise improves repeated sprint performance in a hot environment without altering physiological or neuroendocrinological responses. RPE is reduced and may partially explain the performance improvement.

  11. Participant experiences from chronic administration of a multivitamin versus placebo on subjective health and wellbeing: a double-blind qualitative analysis of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sarris Jerome

    2012-12-01

    Full Text Available Abstract Background While many randomised controlled trials have been conducted on multivitamins, to our knowledge no qualitative research exploring the subjective experience of taking a multivitamin during a clinical trial has been reported. Methods Semi-structured and open-ended written questions were incorporated into a 16-week double-blind, randomised, placebo-controlled, parallel groups trial of once-daily multivitamin administration. At the final study visit (week 16, three open-ended questions were posed to elucidate any positive, negative or unusual experiences from taking either the multivitamin or matched placebo. Qualitative thematic analysis was undertaken by researchers who were blind as to treatment condition of participants, and triangulation (independent analysis from three researchers was employed to ensure methodological rigour. Participant’s experiences were categorised as “positive” or “negative” and a Chi Square analysis was then applied to each of the experiential themes, to compare experiences between the multivitamin and placebo groups, (subdividing the groups by gender. Usual experiences were categorised and discussed separately. Results Of the 182 participants enrolled, 116 completed the study and qualitative data were available from 114 participants. Thematic analysis revealed significant effects in favour of the multivitamin over placebo for participants experiencing increased energy levels (p=.022 and enhanced mood (p=.027. The beneficial effect on energy levels was particularly evident among female participants. A trend was found for participants reporting better sleep in the multivitamin over placebo. The multivitamin and placebo groups did not significantly differ in perceived positive or negative effects in areas relating to other aspects of mental function or physical health. No significant negative effects were revealed, although there was a non-significant trend for more people in the multivitamin

  12. Understanding experiences of participating in a weight loss lifestyle intervention trial: a qualitative evaluation of South Asians at high risk of diabetes.

    Science.gov (United States)

    Morrison, Zoe; Douglas, Anne; Bhopal, Raj; Sheikh, Aziz

    2014-06-20

    To explore the reasons for enrolling, experiences of participating and reasons for remaining in a family-based, cluster randomised controlled trial of a dietitian-delivered lifestyle modification intervention aiming to reduce obesity in South Asians at high risk of developing diabetes. Qualitative study using narrative interviews of a purposive sample of trial participants following completion of the intervention. Data were thematically analysed. The intervention was conducted in Scotland and resulted in a modest decrease in weight, but did not statistically reduce the incidence of diabetes. We conducted 21 narrative interviews with 24 participants (20 trial participants and four family volunteers). Many participants were motivated to participate because of: known family history of diabetes and the desire to better understand diabetes-related risks to their own and their family's health; ways to mitigate these risks and to benefit from personalised monitoring. Home-based interventions, communication in the participant's chosen language(s) and continuity in dietitians supported their continuing engagement with the trial. Adaptations in food choices were initially accommodated by participants, although social and faith-based responsibilities were reported as important barriers to persevering with agreed dietary goals. Many participants reported that increasing their level of physical activity was difficult given their long working hours, physically demanding employment and domestic commitments; this being compounded by Scotland's challenging climate and a related reluctance to exercise in the outdoors. Although participants had strong personal interests in participation and found the information provided by dietitians useful, they nonetheless struggled to incorporate the dietary and exercise recommendations into their daily lives. In particular, increasing levels of physical exercise was described as an additional and in some cases unachievable burden. Consideration

  13. One-stage individual participant data meta-analysis models: estimation of treatment-covariate interactions must avoid ecological bias by separating out within-trial and across-trial information.

    Science.gov (United States)

    Hua, Hairui; Burke, Danielle L; Crowther, Michael J; Ensor, Joie; Tudur Smith, Catrin; Riley, Richard D

    2017-02-28

    Stratified medicine utilizes individual-level covariates that are associated with a differential treatment effect, also known as treatment-covariate interactions. When multiple trials are available, meta-analysis is used to help detect true treatment-covariate interactions by combining their data. Meta-regression of trial-level information is prone to low power and ecological bias, and therefore, individual participant data (IPD) meta-analyses are preferable to examine interactions utilizing individual-level information. However, one-stage IPD models are often wrongly specified, such that interactions are based on amalgamating within- and across-trial information. We compare, through simulations and an applied example, fixed-effect and random-effects models for a one-stage IPD meta-analysis of time-to-event data where the goal is to estimate a treatment-covariate interaction. We show that it is crucial to centre patient-level covariates by their mean value in each trial, in order to separate out within-trial and across-trial information. Otherwise, bias and coverage of interaction estimates may be adversely affected, leading to potentially erroneous conclusions driven by ecological bias. We revisit an IPD meta-analysis of five epilepsy trials and examine age as a treatment effect modifier. The interaction is -0.011 (95% CI: -0.019 to -0.003; p = 0.004), and thus highly significant, when amalgamating within-trial and across-trial information. However, when separating within-trial from across-trial information, the interaction is -0.007 (95% CI: -0.019 to 0.005; p = 0.22), and thus its magnitude and statistical significance are greatly reduced. We recommend that meta-analysts should only use within-trial information to examine individual predictors of treatment effect and that one-stage IPD models should separate within-trial from across-trial information to avoid ecological bias. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd

  14. Willingness to participate in HIV vaccine trials among men who have sex with men in Chennai and Mumbai, India: a social ecological approach.

    Science.gov (United States)

    Chakrapani, Venkatesan; Newman, Peter A; Singhal, Neeti; Jerajani, Jhalak; Shunmugam, Murali

    2012-01-01

    Recruitment of low- and middle-income country volunteers from most-at-risk populations in HIV vaccine trials is essential to vaccine development. In India, men who have sex with men (MSM) are at disproportionately high risk for HIV infection and an important population for trial recruitment. Investigations of willingness to participate (WTP) in HIV vaccine trials have focused predominantly on individual-level determinants. We explored multi-level factors associated with WTP among MSM in India. We conducted 12 focus groups (n = 68) with low socioeconomic MSM in Chennai and Mumbai, and 14 key informant interviews with MSM community leaders and service providers. Focus groups/interviews were recorded, transcribed and translated into English. Two bilingual investigators conducted thematic analysis using line-by-line coding and a constant comparative method, with member-checking by community representatives. Factors associated with WTP were evidenced across the social ecology of MSM-social-structural: poverty, HIV-, sexual- and gender non-conformity stigma, institutionalized discrimination and government sponsorship of trials; community-level: endorsement by MSM community leaders and organizations, and fear of within-group discrimination; interpersonal: anticipated family discord, partner rejection, having financially-dependent family members and disclosure of same-sex sexuality; and individual-level: HIV vaccine trial knowledge and misconceptions, safety concerns, altruism and preventive misconception. Pervasive familial, community and social-structural factors characteristic of the Indian sociocultural context may complicate individual-focused approaches to WTP and thereby constrain the effectiveness of interventions to support recruitment and retention in HIV vaccine trials. Interventions to reduce stigma and discrimination against MSM and people living with HIV, capacity-building of MSM community organizations and transparent communications tailored to the knowledge

  15. Testing the effectiveness of a mentoring intervention to improve social participation of adolescents with visual impairments: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Heppe, Eline C M; Kef, Sabina; Schuengel, Carlo

    2015-11-05

    Social participation is challenging for people with visual impairments. As a result, on average, social networks are smaller, romantic relationships formed later, educational achievements lower, and career prospects limited. Adolescents on their way towards achieving these goals may benefit from the knowledge and experience of adults who have overcome similar difficulties. Therefore, a mentoring intervention, called Mentor Support, will be set up and studied in which adolescents with visual impairments are matched with successfully social participating adults with and without visual impairments. The main objective of this study is to evaluate the effectiveness of Mentor Support. Secondary aims are to distinguish the importance of the disability-specific experience of mentors, predictors of success, and mediating factors. The effect of Mentor Support will be tested in a randomized clinical trial, using pre-test one week before starting, post-test after 12 months, and follow-up after 18 months. Participants will be referred to one of the experimental groups or the control group, and this randomization will be stratified according to country region. Three groups are included in the trial: 40 participants will receive Mentor Support by mentors with a visual impairment in combination with care-as-usual, 40 participants will receive Mentor Support by mentors without visual impairments in combination with care-as-usual, and 40 participants will receive care-as-usual only. Mentor Support consists of 12 face-to-face meetings of the mentee with a mentor with an overall time period of one year. On a weekly basis, dyads have contact via email, the Internet, or telephone. The primary outcome measure is improved social participation within three domains (work/school, leisure activities, and social relationships). Mediator variables are psychosocial functioning and self-determination. Predictors such as demographics and personality are also investigated in order to distinguish

  16. Patient participation in postoperative care activities in patients undergoing total knee replacement surgery: Multimedia Intervention for Managing patient Experience (MIME). Study protocol for a cluster randomised crossover trial.

    Science.gov (United States)

    McDonall, Jo; de Steiger, Richard; Reynolds, John; Redley, Bernice; Livingston, Patricia; Botti, Mari

    2016-07-18

    Patient participation is an important indicator of quality care. Currently, there is little evidence to support the belief that participation in care is possible for patients during the acute postoperative period. Previous work indicates that there is very little opportunity for patients to participate in care in the acute context. Patients require both capability, in terms of having the required knowledge and understanding of how they can be involved in their care, and the opportunity, facilitated by clinicians, to engage in their acute postoperative care. This cluster randomised crossover trial aims to test whether a multimedia intervention improves patient participation in the acute postoperative context, as determined by pain intensity and recovery outcomes. A total of 240 patients admitted for primary total knee replacement surgery will be invited to participate in a cluster randomised, crossover trial and concurrent process evaluation in at least two wards at a major non-profit private hospital in Melbourne, Australia. Patients admitted to the intervention ward will receive the multimedia intervention daily from Day 1 to Day 5 (or day of discharge, if prior). The intervention will be delivered by nurses via an iPad™, comprising information on the goals of care for each day following surgery. Patients admitted to the control ward will receive usual care as determined by care pathways currently in use across the organization. The primary endpoint is the "worst pain experienced in the past 24 h" on Day 3 following TKR surgery. Pain intensity will be measured using the numerical rating scale. Secondary outcomes are interference of pain on activities of daily living, length of stay in hospital, function and pain following TKR surgery, overall satisfaction with hospitalisation, postoperative complications and hospital readmission. The results of this study will contribute to our understanding of the effectiveness of interventions that provide knowledge and

  17. Decision Making in the PICU: An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical Trials

    Directory of Open Access Journals (Sweden)

    Laura E. Slosky

    2014-01-01

    participate were not related to enrollment. Conclusion. Decisions to participate in research by surrogates of children in the PICU appear to relate to child demographics and subtleties in communication; however, no modifiable characteristics were related to increased participation, indicating that the informed consent process may not be compromised in this population.

  18. Effect of Sucrose Analgesia, for Repeated Painful Procedures, on Short-term Neurobehavioral Outcome of Preterm Neonates: A Randomized Controlled Trial.

    Science.gov (United States)

    Banga, Shreshtha; Datta, Vikram; Rehan, Harmeet Singh; Bhakhri, Bhanu Kiran

    2016-04-01

    Safety of oral sucrose, commonly used procedural analgesic in neonates, is questioned. To evaluate the effect of sucrose analgesia, for repeated painful procedures, on short-term neurobehavioral outcome of preterm neonates. Stable preterm neonates were randomized to receive either sucrose or distilled water orally, for every potentially painful procedure during the first 7 days after enrollment. Neurodevelopmental status at 40 weeks postconceptional age (PCA) measured using the domains of Neurobehavioral Assessment of Preterm Infants scale. A total of 93 newborns were analyzed. The baseline characteristics of the groups were comparable. No statistically significant difference was observed in the assessment at 40 weeks PCA, among the groups. Use of sucrose analgesia, for repeated painful procedures on newborns, does not lead to any significant difference in the short-term neurobehavioral outcome. © The Author [2015]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  19. How Bioethics is Complementing Human Rights in Realizing Health Access for Clinical Trial Participants: The Case of Formative PrEP Access in South Africa.

    Science.gov (United States)

    Singh, Jerome

    2015-06-11

    Following the demise of apartheid, human rights in South Africa are now constitutionally enshrined.The right to health in South Africa's Constitution has been credited with transforming the lives of millions of people by triggering programmatic reforms in HIV treatment and the prevention of mother to child transmission (MTCT) of HIV.However, a constitutionally enshrined right to health offers no guarantee that clinical trial participants will enjoy post-trial access to beneficial interventions. Using access to HIV pre-exposure prophylaxis (PrEP) in South Africa as an example, this paper argues that adherence to bioethics norms could realize the right to health for trial participants following the end of a clinical trial. Copyright 2015 Singh. This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited.

  20. Participating in and delivering the ATEAM trial (Alexander technique lessons, exercise, and massage) interventions for chronic back pain: A qualitative study of professional perspectives.

    Science.gov (United States)

    Beattie, Angela; Shaw, Alison; Yardley, Lucy; Little, Paul; Sharp, Debbie

    2010-01-01

    To outline professionals' experiences of participation, perceived benefits and acceptability of the interventions delivered in the ATEAM trial (Alexander technique lessons, exercise, and massage), for patients with chronic or recurrent back pain. Qualitative study using in-depth interviews was conducted with a purposeful sample of twenty professionals (general practitioners (GPs), nurses, Alexander technique teachers, and massage therapists). Data were recorded, transcribed, and analysed thematically using the constant comparison method. Evidence of effectiveness GPs wanted an evidence base for the interventions, whilst nurses, Alexander technique teachers and massage therapists perceived patient reports of benefit as evidence. Professionals' perception of the acceptability of the intervention: professional perspectives differed, with GPs and nurses viewing the structured nature of exercise prescription and Alexander technique lessons as more beneficial and acceptable than massage in alleviating patients' back pain. Economic cost: the cost to patients pursuing Alexander technique lessons and massage was perceived to be a barrier outside the trial. Inter-professional communication: there was little communication between the professionals groups within the trial. Valuable insights have been gained into the perceived benefits and acceptability of exercise, Alexander technique lessons and massage as interventions for chronic back pain. Lessons in the Alexander technique with or without exercise, was perceived as more beneficial and acceptable than massage by professionals who participated and delivered the ATEAM trial interventions. Copyright 2010 Elsevier Ltd. All rights reserved.

  1. Repeatability of hypoxia PET imaging using [{sup 18}F]HX4 in lung and head and neck cancer patients: a prospective multicenter trial

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    Zegers, Catharina M.L.; Elmpt, Wouter van; Lambin, Philippe [Maastricht University Medical Centre, Department of Radiation Oncology (MAASTRO), GROW - School for Oncology and Developmental Biology, Maastricht (Netherlands); Szardenings, Katrin [Threshold Pharmaceuticals, South San Francisco, CA (United States); Kolb, Hartmuth; Chien, David [Siemens Medical Solutions USA, Inc., Siemens Molecular Imaging Biomarker Research, Culver City, CA (United States); Waxman, Alan [Cedars-Sinai Medical Center, Los Angeles, CA (United States); Subramaniam, Rathan M. [Boston University School of Medicine, Boston, MA (United States); Johns Hopkins Medical Institutions, Division of Nuclear Medicine, Russell H Morgan Department of Radiology and Radiologic Sciences, Baltimore, MD (United States); Moon, Dae Hyuk [University of Ulsan College of Medicine, Department of Nuclear Medicine, Asan Medical Center, Seoul (Korea, Republic of); Brunetti, Jacqueline C. [Holy Name Medical Center, Teaneck, NJ (United States); Srinivas, Shyam M. [Cleveland Clinic, Department of Nuclear Medicine, Imaging Institute, Cleveland, OH (United States)

    2015-11-15

    Hypoxia is an important factor influencing tumor progression and treatment efficacy. The aim of this study was to investigate the repeatability of hypoxia PET imaging with [{sup 18}F]HX4 in patients with head and neck and lung cancer. Nine patients with lung cancer and ten with head and neck cancer were included in the analysis (NCT01075399). Two sequential pretreatment [{sup 18}F]HX4 PET/CT scans were acquired within 1 week. The maximal and mean standardized uptake values (SUV{sub max} and SUV{sub mean}) were defined and the tumor-to-background ratios (TBR) were calculated. In addition, hypoxic volumes were determined as the volume of the tumor with a TBR >1.2 (HV{sub 1.2}). Bland Altman analysis of the uptake parameters was performed and coefficients of repeatability were calculated. To evaluate the spatial repeatability of the uptake, the PET/CT images were registered and a voxel-wise comparison of the uptake was performed, providing a correlation coefficient. All parameters of [{sup 18}F]HX4 uptake were significantly correlated between scans: SUV{sub max} (r = 0.958, p < 0.001), SUV{sub mean} (r = 0.946, p < 0.001), TBR{sub max} (r = 0.962, p < 0.001) and HV{sub 1.2} (r = 0.995, p < 0.001). The relative coefficients of repeatability were 15 % (SUV{sub mean}), 17 % (SUV{sub max}) and 17 % (TBR{sub max}). Voxel-wise analysis of the spatial uptake pattern within the tumors provided an average correlation of 0.65 ± 0.14. Repeated hypoxia PET scans with [{sup 18}F]HX4 provide reproducible and spatially stable results in patients with head and neck cancer and patients with lung cancer. [{sup 18}F]HX4 PET imaging can be used to assess the hypoxic status of tumors and has the potential to aid hypoxia-targeted treatments. (orig.)

  2. Inhibitors and facilitators of willingness to participate (WTP) in an HIV vaccine trial: construction and initial validation of the Inhibitors and Facilitators of Willingness to Participate Scale (WPS) among women at risk for HIV infection.

    Science.gov (United States)

    Fincham, Dylan; Kagee, Ashraf; Swartz, Leslie

    2010-04-01

    A psychometric scale assessing inhibitors and facilitators of willingness to participate (WTP) in an HIV vaccine trial has not yet been developed. This study aimed to construct and derive the exploratory factor structure of such a scale. The 35-item Inhibitors and Facilitators of Willingness to Participate Scale (WPS) was developed and administered to a convenience sample of 264 Black females between the ages of 16 and 49 years living in an urban-informal settlement near Cape Town. The subscales of the WPS demonstrated good internal consistency with Cronbach's alpha coefficients ranging between 0.69 and 0.82. A principal components exploratory factor analysis revealed the presence of five latent factors. The factors, which accounted for 45.93% of the variance in WTP, were (1) personal costs, (2) safety and convenience, (3) stigmatisation, (4) personal gains and (5) social approval and trust. Against the backdrop of the study limitations, these results provide initial support for the reliability and construct validity of the WPS among the most eligible trial participants in the Western Cape of South Africa.

  3. Participants? perspectives on mindfulness-based cognitive therapy for inflammatory bowel disease: a qualitative study nested within a pilot randomised controlled trial

    OpenAIRE

    Schoultz, Mariyana; Macaden, Leah; Hubbard, Gill

    2016-01-01

    Background Mindfulness-based interventions have shown to improve depression and anxiety symptoms as well as quality of life in patients with inflammatory bowel disease (IBD). However, little is known about the experiences of this group of patients participating in mindfulness interventions. This paper sets out to explore the perspectives of patients with IBD recruited to a pilot randomised controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) about the intervention. Methods In ...

  4. Recruitment, screening, and baseline participant characteristics in the WALK 2.0 study: A randomized controlled trial using web 2.0 applications to promote physical activity

    Directory of Open Access Journals (Sweden)

    Cristina M. Caperchione

    2016-04-01

    Conclusion: The results of this recruitment process demonstrate the successful use of multiple strategies to obtain a diverse sample of adults eligible to take part in a web-based physical activity promotion intervention. The use of dual screening processes ensured safe participation in the intervention. This approach to recruitment and physical activity screening can be used as a model for further trials in this area.

  5. Participant and caregiver experience of the Nintendo Wii Sports™ after stroke: qualitative study of the trial of Wii™ in stroke (TWIST).

    Science.gov (United States)

    Wingham, Jenny; Adie, Katja; Turner, David; Schofield, Christine; Pritchard, Colin

    2015-03-01

    To understand stroke survivors and their caregivers' experience and acceptability of using the Nintendo Wii Sports™ games (Wii™) as a home-based arm rehabilitation tool. A qualitative study within a randomized controlled trial investigating the effectiveness of using the Wii™ for arm rehabilitation. Data were analysed using thematic analysis. Participants and carers were interviewed in their homes. Eleven male and seven female participants and 10 caregivers who were taking part in the randomized controlled trial within six months of stroke. Median age 65. All participants were using the Wii™ for arm rehabilitation. Semi-structured interviews. Five themes were identified: diligence of play, perceived effectiveness, acceptability, caregiver and social support, and the set-up and administration of the Wii™. Participants appreciated the ability to maintain a social role and manage other comorbidities around the use of the Wii™. A small number of participants found the Mii characters too childlike for adult rehabilitation. The most popular game to start the rehabilitation programme was bowling. As confidence grew, tennis was the most popular, with baseball and boxing being the least popular games. Caregivers provided some practical support and encouragement to play the Wii™. The Wii™ may provide an engaging and flexible form of rehabilitation with relatively high reported usage rates in a home setting. The Wii™ was acceptable to this sample of patients and their caregivers in home-based rehabilitation of the arm following stroke. © The Author(s) 2014.

  6. ParticiPAte CP: a protocol of a randomised waitlist controlled trial of a motivational and behaviour change therapy intervention to increase physical activity through meaningful participation in children with cerebral palsy.

    Science.gov (United States)

    Reedman, Sarah Elizabeth; Boyd, Roslyn N; Elliott, Catherine; Sakzewski, Leanne

    2017-08-07

    Children with cerebral palsy (CP) participate in leisure-time physical activities (PA) less often, with less intensity and reduced diversity than their typically developing peers. Participation in leisure-time physical activities may be an important source of habitual physical activity (HPA) for children with CP, who as a group have lower levels of HPA and increased sedentary time compared with their typically developing peers. The proposed study aims to compare the efficacy of a participation focused therapy (ParticiPAte CP) to usual care in a pragmatic, randomised waitlist controlled trial. Thirty-six children with CP (18 in each group), classified as Gross Motor Function Classification System levels I to III, aged between 8 and 12 years will be recruited across South East Queensland, Australia. Children will be randomised to receive either ParticiPAte CP or waitlist usual care using concealed allocation. ParticiPAte CP is an individually tailored, goal-directed intervention model of pragmatic participation-focused therapy using a toolbox of evidence-based strategies in the treatment of children with CP. This will include goal-setting; identification of barriers and facilitators to participation goals, strategy formation and planning and communication guided by principles of Self-Determination Theory using strategies of Motivational Interviewing. The intervention comprises 8 weekly sessions of 1 hour duration conducted by a physiotherapist in the child's home or community. ACTRN12615001064594. © 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.

  7. Recruitment, screening, and baseline participant characteristics in the WALK 2.0 study: A randomized controlled trial using web 2.0 applications to promote physical activity.

    Science.gov (United States)

    Caperchione, Cristina M; Duncan, Mitch J; Rosenkranz, Richard R; Vandelanotte, Corneel; Van Itallie, Anetta K; Savage, Trevor N; Hooker, Cindy; Maeder, Anthony J; Mummery, W Kerry; Kolt, Gregory S

    2016-04-15

    To describe in detail the recruitment methods and enrollment rates, the screening methods, and the baseline characteristics of a sample of adults participating in the Walk 2.0 Study, an 18 month, 3-arm randomized controlled trial of a Web 2.0 based physical activity intervention. A two-fold recruitment plan was developed and implemented, including a direct mail-out to an extract from the Australian Electoral Commission electoral roll, and other supplementary methods including email and telephone. Physical activity screening involved two steps: a validated single-item self-report instrument and the follow-up Active Australia Questionnaire. Readiness for physical activity participation was also based on a two-step process of administering the Physical Activity Readiness Questionnaire and, where needed, further clearance from a medical practitioner. Across all recruitment methods, a total of 1244 participants expressed interest in participating, of which 656 were deemed eligible. Of these, 504 were later enrolled in the Walk 2.0 trial (77% enrollment rate) and randomized to the Walk 1.0 group (n = 165), the Walk 2.0 group (n = 168), or the Logbook group (n = 171). Mean age of the total sample was 50.8 years, with 65.2% female and 79.1% born in Australia. The results of this recruitment process demonstrate the successful use of multiple strategies to obtain a diverse sample of adults eligible to take part in a web-based physical activity promotion intervention. The use of dual screening processes ensured safe participation in the intervention. This approach to recruitment and physical activity screening can be used as a model for further trials in this area.

  8. Retention of black and white participants in the selenium and vitamin E cancer prevention trial (SWOG-coordinated intergroup study S0000).

    Science.gov (United States)

    Arnold, Kathryn B; Hermos, John A; Anderson, Karen B; Minasian, Lori; Tangen, Catherine M; Probstfield, Jeffrey F; Cook, Elise D

    2014-12-01

    Disproportionally low retention of minority populations can adversely affect the generalizability of clinical research trials. We determine the overall retention rates for White and Black participants from the Selenium and Vitamin E Cancer Prevention Trial (SELECT) and explore participant and site characteristics associated with retention failure (study disengagement) for these groups. A secondary analysis of 28,118 White (age ≥55), and 4,322 Black (age ≥ 50) SELECT participants used multivariate Cox regression to estimate overall retention rates and to calculate HRs and 95% confidence intervals (CI). Blacks had higher age-adjusted risk of disengagement than Whites (HR, 1.92; 95% CI, 1.77-2.08). Among Black participants, those ages 50 to 54 were at three times the risk of disengagement than those ≥65 years of age (HR, 3.61; 95% CI, 2.41-5.41). Blacks age ≥65 had 1.6 times the risk of disengagement than Whites age ≥65 (HR, 1.60; 95% CI, 1.38-1.87). By 6 years after randomization, 84% of Whites and 69% of Blacks remained engaged in the study. Current smoking status was an independent risk factor for study disengagement for both White and Black participants. For both groups, sites whose staffs missed SELECT training sessions or who received SELECT Retention and Adherence grants were associated with increased and decreased disengagement risks, respectively. SELECT retention was disproportionately lower for Blacks than for Whites. The observed difference in retention rates for Blacks and Whites and factors identified by race for study disengagement in SELECT may inform retention efforts for future long-term, cancer prevention trials. ©2014 American Association for Cancer Research.

  9. The Building Wealth and Health Network: methods and baseline characteristics from a randomized controlled trial for families with young children participating in temporary assistance for needy families (TANF

    Directory of Open Access Journals (Sweden)

    Jing Sun

    2016-07-01

    Full Text Available Abstract Background Families with children under age six participating in the Temporary Assistance for Needy Families Program (TANF must participate in work-related activities for 20 h per week. However, due to financial hardship, poor health, and exposure to violence and adversity, families may experience great difficulty in reaching self-sufficiency. The purpose of this report is to describe study design and baseline findings of a trauma-informed financial empowerment and peer support intervention meant to mitigate these hardships. Methods We conducted a randomized controlled trial of a 28-week intervention called Building Wealth and Health Network to improve financial security and maternal and child health among caregivers participating in TANF. Participants, recruited from County Assistance offices in Philadelphia, PA, were randomized into two intervention groups (partial and full and one control group. Participants completed questionnaires at baseline to assess career readiness, economic hardship, health and wellbeing, exposure to adversity and violence, and interaction with criminal justice systems. Results Baseline characteristics demonstrate that among 103 participants, there were no significant differences by group. Mean age of participants was 25 years, and youngest child was 30 months. The majority of participants were women (94.2 %, never married (83.5 %, unemployed (94.2 %, and without a bank account (66.0 %. Many reported economic hardship (32.0 % very low household food secure, 65.0 % housing insecure, and 31.1 % severe energy insecure, and depression (57.3 %. Exposure to adversity was prevalent, where 38.8 % reported four or more Adverse Childhood Experiences including abuse, neglect and household dysfunction. In terms of community violence, 64.7 % saw a seriously wounded person after an incident of violence, and 27.2 % had seen someone killed. Finally, 14.6 % spent time in an adult correctional institution, and 48

  10. Clinical Trials

    Medline Plus

    Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...

  11. Rationale and design of the iPap trial: a randomized controlled trial of home-based HPV self-sampling for improving participation in cervical screening by never- and under-screened women in Australia

    International Nuclear Information System (INIS)

    Sultana, Farhana; Gertig, Dorota M; English, Dallas R; Simpson, Julie A; Brotherton, Julia ML; Drennan, Kelly; Mullins, Robyn; Heley, Stella; Wrede, C David; Saville, Marion

    2014-01-01

    Organized screening based on Pap tests has substantially reduced deaths from cervical cancer in many countries, including Australia. However, the impact of the program depends upon the degree to which women participate. A new method of screening, testing for human papillomavirus (HPV) DNA to detect the virus that causes cervical cancer, has recently become available. Because women can collect their own samples for this test at home, it has the potential to overcome some of the barriers to Pap tests. The iPap trial will evaluate whether mailing an HPV self-sampling kit increases participation by never- and under-screened women within a cervical screening program. The iPap trial is a parallel randomized controlled, open label, trial. Participants will be Victorian women age 30–69 years, for whom there is either no record on the Victorian Cervical Cytology Registry (VCCR) of a Pap test (never-screened) or the last recorded Pap test was between five to fifteen years ago (under-screened). Enrolment information from the Victorian Electoral Commission will be linked to the VCCR to determine the never-screened women. Variables that will be used for record linkage include full name, address and date of birth. Never- and under-screened women will be randomly allocated to either receive an invitation letter with an HPV self-sampling kit or a reminder letter to attend for a Pap test, which is standard practice for women overdue for a test in Victoria. All resources have been focus group tested. The primary outcome will be the proportion of women who participate, by returning an HPV self-sampling kit for women in the self-sampling arm, and notification of a Pap test result to the Registry for women in the Pap test arm at 3 and 6 months after mailout. The most important secondary outcome is the proportion of test-positive women who undergo further investigations at 6 and 12 months after mailout of results. The iPap trial will provide strong evidence about whether HPV self

  12. Patients' experiences of breathing retraining for asthma: a qualitative process analysis of participants in the intervention arms of the BREATHE trial.

    Science.gov (United States)

    Arden-Close, Emily; Yardley, Lucy; Kirby, Sarah; Thomas, Mike; Bruton, Anne

    2017-10-05

    Poor symptom control and impaired quality of life are common in adults with asthma, and breathing retraining exercises may be an effective method of self-management. This study aimed to explore the experiences of participants in the intervention arms of the BREATHE trial, which investigated the effectiveness of breathing retraining as a mode of asthma management. Sixteen people with asthma (11 women, 8 per group) who had taken part in the intervention arms of the BREATHE trial (breathing retraining delivered by digital versatile disc (DVD) or face-to-face sessions with a respiratory physiotherapist) took part in semi-structured telephone interviews about their experiences. Interviews were analysed using thematic analysis. Breathing retraining was perceived positively as a method of asthma management. Motivations for taking part included being asked, to enhance progress in research, to feel better/reduce symptoms, and to reduce medication. Participants were positive about the physiotherapist, liked having the materials tailored, found meetings motivational, and liked the DVD and booklet. The impact of breathing retraining following regular practice included increased awareness of breathing and development of new habits. Benefits of breathing retraining included increased control over breathing, reduced need for medication, feeling more relaxed, and improved health and quality of life. Problems included finding time to practice the exercises, and difficulty mastering techniques. Breathing retraining was acceptable and valued by almost all participants, and many reported improved wellbeing. Face to face physiotherapy was well received. However, some participants in the DVD group mentioned being unable to master techniques. PATIENTS RECEPTIVE TO BREATHING RETRAINING: Patients with asthma taught how to change their unconscious breathing patterns generally like non-pharmacological interventions. Researchers in the UK, led by Mike Thomas from the University of Southampton

  13. WE-B-207-02: CT Lung Cancer Screening and the Medical Physicist: A Dosimetry Summary of CT Participants in the National Lung Cancer Screening Trial (NLST)

    International Nuclear Information System (INIS)

    Lee, C.

    2015-01-01

    The US National Lung Screening Trial (NLST) was a multi-center randomized, controlled trial comparing a low-dose CT (LDCT) to posterior-anterior (PA) chest x-ray (CXR) in screening older, current and former heavy smokers for early detection of lung cancer. Recruitment was launched in September 2002 and ended in April 2004 when 53,454 participants had been randomized at 33 screening sites in equal proportions. Funded by the National Cancer Institute this trial demonstrated that LDCT screening reduced lung cancer mortality. The US Preventive Services Task Force (USPSTF) cited NLST findings and conclusions in its deliberations and analysis of lung cancer screening. Under the 2010 Patient Protection and Affordable Care Act, the USPSTF favorable recommendation regarding lung cancer CT screening assisted in obtaining third-party payers coverage for screening. The objective of this session is to provide an introduction to the NLST and the trial findings, in addition to a comprehensive review of the dosimetry investigations and assessments completed using individual NLST participant CT and CXR examinations. Session presentations will review and discuss the findings of two independent assessments, a CXR assessment and the findings of a CT investigation calculating individual organ dosimetry values. The CXR assessment reviewed a total of 73,733 chest x-ray exams that were performed on 92 chest imaging systems of which 66,157 participant examinations were used. The CT organ dosimetry investigation collected scan parameters from 23,773 CT examinations; a subset of the 75,133 CT examinations performed using 97 multi-detector CT scanners. Organ dose conversion coefficients were calculated using a Monte Carlo code. An experimentally-validated CT scanner simulation was coupled with 193 adult hybrid computational phantoms representing the height and weight of the current U.S. population. The dose to selected organs was calculated using the organ dose library and the abstracted scan

  14. WE-B-207-01: CT Lung Cancer Screening and the Medical Physicist: Background, Findings and Participant Dosimetry Summary of the National Lung Screening Trial (NLST)

    International Nuclear Information System (INIS)

    Kruger, R.

    2015-01-01

    The US National Lung Screening Trial (NLST) was a multi-center randomized, controlled trial comparing a low-dose CT (LDCT) to posterior-anterior (PA) chest x-ray (CXR) in screening older, current and former heavy smokers for early detection of lung cancer. Recruitment was launched in September 2002 and ended in April 2004 when 53,454 participants had been randomized at 33 screening sites in equal proportions. Funded by the National Cancer Institute this trial demonstrated that LDCT screening reduced lung cancer mortality. The US Preventive Services Task Force (USPSTF) cited NLST findings and conclusions in its deliberations and analysis of lung cancer screening. Under the 2010 Patient Protection and Affordable Care Act, the USPSTF favorable recommendation regarding lung cancer CT screening assisted in obtaining third-party payers coverage for screening. The objective of this session is to provide an introduction to the NLST and the trial findings, in addition to a comprehensive review of the dosimetry investigations and assessments completed using individual NLST participant CT and CXR examinations. Session presentations will review and discuss the findings of two independent assessments, a CXR assessment and the findings of a CT investigation calculating individual organ dosimetry values. The CXR assessment reviewed a total of 73,733 chest x-ray exams that were performed on 92 chest imaging systems of which 66,157 participant examinations were used. The CT organ dosimetry investigation collected scan parameters from 23,773 CT examinations; a subset of the 75,133 CT examinations performed using 97 multi-detector CT scanners. Organ dose conversion coefficients were calculated using a Monte Carlo code. An experimentally-validated CT scanner simulation was coupled with 193 adult hybrid computational phantoms representing the height and weight of the current U.S. population. The dose to selected organs was calculated using the organ dose library and the abstracted scan

  15. WE-B-207-02: CT Lung Cancer Screening and the Medical Physicist: A Dosimetry Summary of CT Participants in the National Lung Cancer Screening Trial (NLST)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, C. [National Cancer Institute (United States)

    2015-06-15

    The US National Lung Screening Trial (NLST) was a multi-center randomized, controlled trial comparing a low-dose CT (LDCT) to posterior-anterior (PA) chest x-ray (CXR) in screening older, current and former heavy smokers for early detection of lung cancer. Recruitment was launched in September 2002 and ended in April 2004 when 53,454 participants had been randomized at 33 screening sites in equal proportions. Funded by the National Cancer Institute this trial demonstrated that LDCT screening reduced lung cancer mortality. The US Preventive Services Task Force (USPSTF) cited NLST findings and conclusions in its deliberations and analysis of lung cancer screening. Under the 2010 Patient Protection and Affordable Care Act, the USPSTF favorable recommendation regarding lung cancer CT screening assisted in obtaining third-party payers coverage for screening. The objective of this session is to provide an introduction to the NLST and the trial findings, in addition to a comprehensive review of the dosimetry investigations and assessments completed using individual NLST participant CT and CXR examinations. Session presentations will review and discuss the findings of two independent assessments, a CXR assessment and the findings of a CT investigation calculating individual organ dosimetry values. The CXR assessment reviewed a total of 73,733 chest x-ray exams that were performed on 92 chest imaging systems of which 66,157 participant examinations were used. The CT organ dosimetry investigation collected scan parameters from 23,773 CT examinations; a subset of the 75,133 CT examinations performed using 97 multi-detector CT scanners. Organ dose conversion coefficients were calculated using a Monte Carlo code. An experimentally-validated CT scanner simulation was coupled with 193 adult hybrid computational phantoms representing the height and weight of the current U.S. population. The dose to selected organs was calculated using the organ dose library and the abstracted scan

  16. WE-B-207-01: CT Lung Cancer Screening and the Medical Physicist: Background, Findings and Participant Dosimetry Summary of the National Lung Screening Trial (NLST)

    Energy Technology Data Exchange (ETDEWEB)

    Kruger, R. [Marshfield Clinic, Marshfield, WI (United States)

    2015-06-15

    The US National Lung Screening Trial (NLST) was a multi-center randomized, controlled trial comparing a low-dose CT (LDCT) to posterior-anterior (PA) chest x-ray (CXR) in screening older, current and former heavy smokers for early detection of lung cancer. Recruitment was launched in September 2002 and ended in April 2004 when 53,454 participants had been randomized at 33 screening sites in equal proportions. Funded by the National Cancer Institute this trial demonstrated that LDCT screening reduced lung cancer mortality. The US Preventive Services Task Force (USPSTF) cited NLST findings and conclusions in its deliberations and analysis of lung cancer screening. Under the 2010 Patient Protection and Affordable Care Act, the USPSTF favorable recommendation regarding lung cancer CT screening assisted in obtaining third-party payers coverage for screening. The objective of this session is to provide an introduction to the NLST and the trial findings, in addition to a comprehensive review of the dosimetry investigations and assessments completed using individual NLST participant CT and CXR examinations. Session presentations will review and discuss the findings of two independent assessments, a CXR assessment and the findings of a CT investigation calculating individual organ dosimetry values. The CXR assessment reviewed a total of 73,733 chest x-ray exams that were performed on 92 chest imaging systems of which 66,157 participant examinations were used. The CT organ dosimetry investigation collected scan parameters from 23,773 CT examinations; a subset of the 75,133 CT examinations performed using 97 multi-detector CT scanners. Organ dose conversion coefficients were calculated using a Monte Carlo code. An experimentally-validated CT scanner simulation was coupled with 193 adult hybrid computational phantoms representing the height and weight of the current U.S. population. The dose to selected organs was calculated using the organ dose library and the abstracted scan

  17. A novel use of a statewide telecolposcopy network for recruitment of participants in a Phase I clinical trial of a human papillomavirus therapeutic vaccine.

    Science.gov (United States)

    Stratton, Shawna L; Spencer, Horace J; Greenfield, William W; Low, Gordon; Hitt, Wilbur C; Quick, Charles M; Jeffus, Susanne K; Blackmon, Victoria; Nakagawa, Mayumi

    2015-06-01

    Historically, recruitment and retention of young women in intervention-based clinical trials have been challenging. In August 2012, enrollment for a clinical trial testing of an investigational human papillomavirus therapeutic vaccine called PepCan was opened at our institution. This study was an open-label, single-arm, single-institution, dose-escalation Phase I clinical trial. Women with recent Papanicolaou smear results showing high-grade squamous intraepithelial lesions or results that could not rule out high-grade squamous intraepithelial lesion were eligible to enroll. Patients with biopsy-confirmed high-grade squamous intraepithelial lesion were also eligible. Colposcopy was performed at the screening visit, and participants became eligible for vaccination when the diagnosis of high-grade squamous intraepithelial lesion was confirmed with biopsy and other inclusion criteria were met. The aim of this study was to identify strategies and factors effective in recruitment and retention of study participants. Potential vaccine candidates were recruited through direct advertisement as well as referrals, including referrals through the Arkansas telecolposcopy network. The network is a federally funded program, administered by physicians and advanced practice nurses. The network telemedically links rural health sites and allows physician-guided colposcopy and biopsies to be conducted by advanced practice nurses. A variety of strategies were employed to assure good retention, including face-to-face contact with the study coordinator at the time of consent and most of study visits; frequent contact using text messaging, phone calls, and e-mails; and creation of a private Facebook page to improve communication among research staff and study participants. A questionnaire, inquiring about motivation for joining the study, occupation, education, household income, number of children, and number of sexual partners, was administered at the screening visit with the intent of

  18. The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial

    Science.gov (United States)

    Thow, Megan; Ferguson, Stuart G

    2016-01-01

    Background Recruiting participants for research studies can be difficult and costly. The popularity of social media platforms (eg, Facebook) has seen corresponding growth in the number of researchers turning to social networking sites and their embedded advertising frameworks to locate eligible participants for studies. Compared with traditional recruitment strategies such as print media, social media advertising has been shown to be favorable in terms of its reach (especially with hard-to-reach populations), cost effectiveness, and usability. However, to date, no studies have examined how participants recruited via social media progress through a study compared with those recruited using more traditional recruitment strategies. Objectives (1) Examine whether visiting the study website prior to being contacted by researchers creates self-screened participants who are more likely to progress through all study phases (eligible, enrolled, completed); (2) compare conversion percentages and cost effectiveness of each recruitment method at each study phase; and, (3) compare demographic and smoking characteristics of participants recruited through each strategy to determine if they attract similar samples. Methods Participants recruited to a smoking cessation clinical trial were grouped by how they had become aware of the study: via social media (Facebook) or traditional media (eg, newspaper, flyers, radio, word of mouth). Groups were compared based on throughput data (conversion percentages and cost) as well as demographic and smoking characteristics. Results Visiting the study website did not result in individuals who were more likely to be eligible for (P=.24), enroll in (P=.20), or complete (P=.25) the study. While using social media was more cost effective than traditional methods when we examined earlier endpoints of the recruitment process (cost to obtain a screened respondent: AUD $22.73 vs $29.35; cost to obtain an eligible respondent: $37.56 vs $44.77), it was

  19. Client satisfaction among participants in a randomized trial comparing oral methadone and injectable diacetylmorphine for long-term opioid-dependency

    Directory of Open Access Journals (Sweden)

    Brissette Suzanne

    2011-07-01

    Full Text Available Abstract Background Substitution with opioid-agonists (e.g., methadone has shown to be an effective treatment for chronic long-term opioid dependency. Patient satisfaction with treatment has been associated with improved addiction treatment outcomes. However, there is a paucity of studies evaluating patients' satisfaction with Opioid Substitution Treatment (OST. In the present study, participants' satisfaction with OST was evaluated at 3 and 12 months. We sought to test the relationship between satisfaction and patients' characteristics, the treatment modality received and treatment outcomes. Methods Data from a randomized controlled trial, the North American Opiate Medication Initiative (NAOMI, conducted in Vancouver and Montreal (Canada between 2005-2008, was analyzed. The NAOMI study compared the effectiveness of oral methadone vs. injectable diacetylmorphine over 12 months. A small sub-group of patients received injectable hydromorphone on a double blind basis with diacetylmorphine. The Client Satisfaction Questionnaire (CSQ-8 was used to measure satisfaction with treatment. CSQ-8 scores, as well as retention and response to treatment, did not differ between those receiving hydromorphone and diacetylmorphine at 3 or 12 months assessments; therefore, these two groups were analyzed together as the 'injectable' treatment group. Results A total of 232 (92% and 237 (94% participants completed the CSQ-8 at 3 and 12 months, respectively. Participants in both groups were highly satisfied with treatment. Independent of treatment group, participants satisfied with treatment at 3 months were more likely to be retained at 12 months. Multivariate analysis indicated that satisfaction was greater among those randomized to the injection group after controlling for treatment effectiveness. Participants who were retained, responded to treatment, and had fewer psychological symptoms were more satisfied with treatment. Finally, open-ended comments were made by

  20. Clinicians’ views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

    OpenAIRE

    Chhoa, C. Y.; Sawyer, A.; Ayers, S.; Pushpa-Rajah, A.; Duley, L.

    2017-01-01

    BACKGROUND: The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. Preterm birth can be rapid and unexpected, allowing little time for the usual consent process. Therefore, in addition to the usual procedure for written consent, a two-stage pathway for consent for use when birth was imminent was developed. The aims of this study were to explore clinicians’ views and experiences of offering two consent pathways for recruit...

  1. Clinicians? views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

    OpenAIRE

    Chhoa, Celine Y.; Sawyer, Alexandra; Ayers, Susan; Pushpa-Rajah, Angela; Duley, Lelia

    2017-01-01

    Background The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. Preterm birth can be rapid and unexpected, allowing little time for the usual consent process. Therefore, in addition to the usual procedure for written consent, a two-stage pathway for consent for use when birth was imminent was developed. The aims of this study were to explore clinicians? views and experiences of offering two consent pathways for recruitment...

  2. The Effect of Participation in Support Groups on Depression, Anxiety and Stress in Family Caregivers of People with Alzheimers: Randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Fahimeh Taati

    2016-07-01

    Full Text Available This study sought to determine the effect of participation in support groups on the depression, anxiety and stress level of caregivers of patients with Alzheimer. This study was a single blind randomized clinical controlled trial (RCT with 80 family caregivers of people with Alzheimer’s (per group=40. The intervention group participated in eight sessions 1.5- 2 hours in support groups. The tool used in this study was the DASS-21 questionnaire for measuring depression, anxiety and stress level of the caregivers, analysis of parametric data, using SPSS version 21. Findings showed, participation in support groups showed no significant difference on depression, anxiety and stress in family caregivers of Alzheimer patients in the control group and the intervention group. Given that caring for these patients by their family members are very sensitive and costly issues for policy makers and health service providers, community and families of these patients.

  3. Improving communication when seeking informed consent: a randomised controlled study of a computer-based method for providing information to prospective clinical trial participants.

    Science.gov (United States)

    Karunaratne, Asuntha S; Korenman, Stanley G; Thomas, Samantha L; Myles, Paul S; Komesaroff, Paul A

    2010-04-05

    To assess the efficacy, with respect to participant understanding of information, of a computer-based approach to communication about complex, technical issues that commonly arise when seeking informed consent for clinical research trials. An open, randomised controlled study of 60 patients with diabetes mellitus, aged 27-70 years, recruited between August 2006 and October 2007 from the Department of Diabetes and Endocrinology at the Alfred Hospital and Baker IDI Heart and Diabetes Institute, Melbourne. Participants were asked to read information about a mock study via a computer-based presentation (n = 30) or a conventional paper-based information statement (n = 30). The computer-based presentation contained visual aids, including diagrams, video, hyperlinks and quiz pages. Understanding of information as assessed by quantitative and qualitative means. Assessment scores used to measure level of understanding were significantly higher in the group that completed the computer-based task than the group that completed the paper-based task (82% v 73%; P = 0.005). More participants in the group that completed the computer-based task expressed interest in taking part in the mock study (23 v 17 participants; P = 0.01). Most participants from both groups preferred the idea of a computer-based presentation to the paper-based statement (21 in the computer-based task group, 18 in the paper-based task group). A computer-based method of providing information may help overcome existing deficiencies in communication about clinical research, and may reduce costs and improve efficiency in recruiting participants for clinical trials.

  4. The Business Case for Provider Participation in Clinical Trials Research: An Application to the National Cancer Institute's Community Clinical Oncology Program

    Science.gov (United States)

    Song, Paula H.; Reiter, Kristin L.; Weiner, Bryan J.; Minasian, Lori; McAlearney, Ann Scheck

    2012-01-01

    Background Provider-based research networks (PBRNs) make clinical trials available in community-based practice settings, where most people receive their care, but provider participation requires both financial and in-kind contributions. Purpose This study explores whether providers believe there is a business case for participating in PBRNs and what factors contribute to the business case. Methodology/Approach We use a multiple case study methodology approach to examine the National Cancer Institute's Community Clinical Oncology Program, a longstanding federally funded PBRN. Interviews with 41 key informants across five sites, selected on the basis of organizational maturity, were conducted using a semi-structured interview guide. We analyzed interview transcripts using an iterative, deductive process to identify themes and subthemes in the data. Findings We found that a business case for provider participation in PBRNs may exist if both direct and indirect financial benefits are identified and included in the analysis, and if the time horizon is long enough to allow those benefits to be realized. We identified specific direct and indirect financial benefits that were perceived as important contributors to the business case and the perceived length of time required for a positive return to accrue. Practice Implications As the lack of a business case may result in provider reluctance to participate in PBRNs, knowledge of the benefits we identified may be crucial to encouraging and sustaining participation, thereby preserving patient access to innovative community-based treatments. The results are also relevant to federally-funded PBRNs outside of oncology or to providers considering participation in any clinical trials research. PMID:23044836

  5. Effect of virtual reality exposure therapy on social participation in people with a psychotic disorder (VRETp): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pot-Kolder, Roos; Veling, Wim; Geraets, Chris; van der Gaag, Mark

    2016-01-13

    Many patients with a psychotic disorder participate poorly in society. When psychotic disorders are in partial remission, feelings of paranoia, delusions of reference, social anxiety and self-stigmatization often remain at diminished severity and may lead to avoidance of places and people. Virtual reality exposure therapy (VRET) is an evidence-based treatment for several anxiety disorders. For patients with a psychotic disorder, the VRETp was developed to help them experience exposure to feared social situations. The present study aims to investigate the effects of VRETp on social participation in real life among patients with a psychotic disorder. The study is a single-blind randomized controlled trial with two conditions: the active condition, in which participants receive the virtual reality treatment together with treatment as usual (TAU), and the waiting list condition, in which participants receive TAU only. The two groups are compared at baseline, at 3 months posttreatment and at 6 months follow-up. All participants on the waiting list are also offered the virtual reality treatment after the follow-up measurements are completed. The primary outcome is social participation. Secondary outcomes are quality of life, interaction anxiety, depression and social functioning in general. Moderator and mediator analyses are conducted with stigma, cognitive schemata, cognitive biases, medication adherence, simulator sickness and presence in virtual reality. If effective, a cost-effectiveness analysis will be conducted. Results from the posttreatment measurement can be considered strong empirical indicators of the effectiveness of VRETp. The 6-month follow-up data may provide reliable documentation of the long-term effects of the treatment on the outcome variables. Data from pre-treatment and mid-treatment can be used to reveal possible pathways of change. Current Controlled Trials: ISRCTN12929657 . Date of registration: 8 September 2015.

  6. The business case for provider participation in clinical trials research: an application to the National Cancer Institute's community clinical oncology program.

    Science.gov (United States)

    Song, Paula H; Reiter, Kristin L; Weiner, Bryan J; Minasian, Lori; McAlearney, Ann Scheck

    2013-01-01

    Provider-based research networks (PBRNs) make clinical trials available in community-based practice settings, where most people receive their care, but provider participation requires both financial and in-kind contributions. The aim of this study was to explore whether providers believe there is a business case for participating in PBRNs and what factors contribute to the business case. We use a multiple case study methodology approach to examine the National Cancer Institute's community clinical oncology program, a long-standing federally funded PBRN. Interviews with 41 key informants across five sites, selected on the basis of organizational maturity, were conducted using a semistructured interview guide. We analyzed interview transcripts using an iterative, deductive process to identify themes and subthemes in the data. We found that a business case for provider participation in PBRNs may exist if both direct and indirect financial benefits are identified and included in the analysis and if the time horizon is long enough to allow those benefits to be realized. We identified specific direct and indirect financial benefits that were perceived as important contributors to the business case and the perceived length of time required for a positive return to accrue. As the lack of a business case may result in provider reluctance to participate in PBRNs, knowledge of the benefits we identified may be crucial to encouraging and sustaining participation, thereby preserving patient access to innovative community-based treatments. The results are also relevant to federally funded PBRNs outside of oncology or to providers considering participation in any clinical trials research.

  7. A Comparison Between Caucasians and African Americans in Willingness to Participate in Cancer Clinical Trials: The Roles of Knowledge, Distrust, Information Sources, and Religiosity.

    Science.gov (United States)

    Meng, Jingbo; McLaughlin, Margaret; Pariera, Katrina; Murphy, Sheila

    2016-06-01

    This study aims to (a) examine the roles of knowledge, distrust in medical professionals, information sources, and 2 dimensions of religiosity (i.e., religious activity and religious belief) in influencing willingness to participate (WTP) in cancer clinical trials and to (b) compare the results for Caucasians and African Americans in order to inform future recruitment. An online survey was fielded via a Knowledge Networks panel with a nationally representative sample including 478 Caucasians and 173 African Americans. The results showed that distrust in medical professionals was a strong barrier to WTP for both ethnic groups, whereas factual knowledge about trial procedures was not associated with WTP for either ethnic group. Seeking trial information from doctors was positively associated with WTP for Caucasians; seeking trial information from hospitals was positively associated with WTP for African Americans. More interestingly, levels of religious activity negatively predicted WTP for Caucasians but positively predicted WTP for African Americans. Self-reported religious belief was not associated with WTP for either ethnic group. In sum, although distrust is a common barrier to WTP, the influence of preferred information sources and religious activity on WTP varies as a function of ethnicity.

  8. Recruitment of Participants and Delivery of Online Mental Health Resources for Depressed Individuals Using Tumblr: Pilot Randomized Control Trial.

    Science.gov (United States)

    Kelleher, Erin; Moreno, Megan; Wilt, Megan Pumper

    2018-04-12

    Adolescents and young adults frequently post depression symptom references on social media; previous studies show positive associations between depression posts and self-reported depression symptoms. Depression is common among young people and this population often experiences many barriers to mental health care. Thus, social media may be a new resource to identify, recruit, and intervene with young people at risk for depression. The purpose of this pilot study was to test a social media intervention on Tumblr. We used social media to identify and recruit participants and to deliver the intervention of online depression resources. This randomized pilot intervention identified Tumblr users age 15-23 who posted about depression using the search term "#depress". Eligible participants were recruited via Tumblr messages; consented participants completed depression surveys and were then randomized to an intervention of online mental health resources delivered via a Tumblr message, while control participants did not receive resources. Postintervention online surveys assessed resource access and usefulness and control groups were asked whether they would have liked to receive resources. Analyses included t tests. A total of 25 participants met eligibility criteria. The mean age of the participants was 17.5 (SD 1.9) and 65% were female with average score on the Patient Health Questionnaire-9 of 17.5 (SD 5.9). Among the 11 intervention participants, 36% (4/11) reported accessing intervention resources and 64% (7/11) felt the intervention was acceptable. Among the 14 control participants, only 29% (4/14) of reported that receiving resources online would be acceptable (P=.02). Participants suggested anonymity and ease of use as important characteristics in an online depression resource. The intervention was appropriately targeted to young people at risk for depression, and recruitment via Tumblr was feasible. Most participants in the intervention group felt the social media

  9. Participation in Training for Depression Care Quality Improvement: A Randomized Trial of Community Engagement or Technical Support.

    Science.gov (United States)

    Chung, Bowen; Ngo, Victoria K; Ong, Michael K; Pulido, Esmeralda; Jones, Felica; Gilmore, James; Stoker-Mtume, Norma; Johnson, Megan; Tang, Lingqi; Wells, Kenneth Brooks; Sherbourne, Cathy; Miranda, Jeanne

    2015-08-01

    Community engagement and planning (CEP) could improve dissemination of depression care quality improvement in underresourced communities, but whether its effects on provider training participation differ from those of standard technical assistance, or resources for services (RS), is unknown. This study compared program- and staff-level participation in depression care quality improvement training among programs enrolled in CEP, which trained networks of health care and social-community agencies jointly, and RS, which provided technical support to individual programs. Matched programs from health care and social-community service sectors in two communities were randomly assigned to RS or CEP. Data were from 1,622 eligible staff members from 95 enrolled programs. Primary outcomes were any staff trained (for programs) and total hours of training (for staff). Secondary staff-level outcomes were hours of training in specific depression collaborative care components. CEP programs were more likely than RS programs to participate in any training (p=.006). Within health care sectors, CEP programs were more likely than RS programs to participate in training (p=.016), but within social-community sectors, there was no difference in training by intervention. Among staff who participated in training, mean training hours were greater among CEP programs versus RS programs for any type of training (ptraining related to each component of depression care (p<.001) except medication management. CEP may be an effective strategy to promote staff participation in depression care improvement efforts in underresourced communities.

  10. A qualitative study of recruitment barriers, motivators, and community-based strategies for increasing clinical trials participation among rural and urban populations.

    Science.gov (United States)

    Friedman, Daniela B; Foster, Caroline; Bergeron, Caroline D; Tanner, Andrea; Kim, Sei-Hill

    2015-01-01

    Participation in clinical trials (CTs) is low among rural communities. Investigators report difficulty recruiting rural individuals for CTs. The study purpose was to identify recruitment barriers, motivators, and strategies to help increase access to and participation in CTs in rural and urban communities. Qualitative focus groups/interviews. Rural and urban counties in one southeastern state. Two hundred twelve African-American and white men and women ages 21+. Nineteen focus groups and nine interviews were conducted. Audio files were transcribed and organized into NVivo10. Recurring themes were examined by geographic location. Although similar barriers, motivators, and strategies were reported by urban and rural groups, perceptions regarding their importance varied. Recruitment barriers mentioned in both rural and urban groups included fear, side effects, limited understanding, limited time, and mistrust. Rural groups were more mindful of time commitment involved. Both rural and urban participants reported financial incentives as the top motivator to CT participation, followed by personal illness (urban groups) and benefits to family (rural groups). Recruitment strategies suggested by rural participants involved working with schools/churches and using word of mouth, whereas partnering with schools, word of mouth, and media were recommended most by urban groups. Perceived recruitment barriers, motivators, and strategies did not differ considerably between rural and urban groups. Major barriers identified by participants should be addressed in future CT recruitment and education efforts. Findings can inform recruitment and communication strategies for reaching both urban and rural communities.

  11. From rehabilitation to recovery: protocol for a randomised controlled trial evaluating a goal-based intervention to reduce depression and facilitate participation post-stroke

    Directory of Open Access Journals (Sweden)

    Hill Keith

    2011-06-01

    Full Text Available Abstract Background There is much discourse in healthcare about the importance of client-centred rehabilitation, however in the realm of community-based therapy post-stroke there has been little investigation into the efficacy of goal-directed practice that reflects patients' valued activities. In addition, the effect of active involvement of carers in such a rehabilitation process and their subsequent contribution to functional and emotional recovery post-stroke is unclear. In community based rehabilitation, interventions based on patients' perceived needs may be more likely to alter such outcomes. In this paper, we describe the methodology of a randomised controlled trial of an integrated approach to facilitating patient goal achievement in the first year post-stroke. The effectiveness of this intervention in reducing the severity of post-stroke depression, improving participation status and health-related quality of life is examined. The impact on carers is also examined. Methods/Design Patients (and their primary carers, if available are randomly allocated to an intervention or control arm of the study. The intervention is multimodal and aims to screen for adverse stroke sequelae and address ways to enhance participation in patient-valued activities. Intervention methods include: telephone contacts, written information provision, home visitation, and contact with treating health professionals, with further relevant health service referrals as required. The control involves treatment as usual, as determined by inpatient and community rehabilitation treating teams. Formal blinded assessments are conducted at discharge from inpatient rehabilitation, and at six and twelve months post-stroke. The primary outcome is depression. Secondary outcome measures include participation and activity status, health-related quality of life, and self-efficacy. Discussion The results of this trial will assist with the development of a model for community

  12. Willingness to Participate in HIV Vaccine Trials among Men Who Have Sex with Men in Chennai and Mumbai, India: A Social Ecological Approach

    Science.gov (United States)

    Chakrapani, Venkatesan; Newman, Peter A.; Singhal, Neeti; Jerajani, Jhalak; Shunmugam, Murali

    2012-01-01

    Background Recruitment of low- and middle-income country volunteers from most-at-risk populations in HIV vaccine trials is essential to vaccine development. In India, men who have sex with men (MSM) are at disproportionately high risk for HIV infection and an important population for trial recruitment. Investigations of willingness to participate (WTP) in HIV vaccine trials have focused predominantly on individual-level determinants. We explored multi-level factors associated with WTP among MSM in India. Methods We conducted 12 focus groups (n = 68) with low socioeconomic MSM in Chennai and Mumbai, and 14 key informant interviews with MSM community leaders and service providers. Focus groups/interviews were recorded, transcribed and translated into English. Two bilingual investigators conducted thematic analysis using line-by-line coding and a constant comparative method, with member-checking by community representatives. Results Factors associated with WTP were evidenced across the social ecology of MSM–social-structural: poverty, HIV-, sexual- and gender non-conformity stigma, institutionalized discrimination and government sponsorship of trials; community-level: endorsement by MSM community leaders and organizations, and fear of within-group discrimination; interpersonal: anticipated family discord, partner rejection, having financially-dependent family members and disclosure of same-sex sexuality; and individual-level: HIV vaccine trial knowledge and misconceptions, safety concerns, altruism and preventive misconception. Conclusion Pervasive familial, community and social-structural factors characteristic of the Indian sociocultural context may complicate individual-focused approaches to WTP and thereby constrain the effectiveness of interventions to support recruitment and retention in HIV vaccine trials. Interventions to reduce stigma and discrimination against MSM and people living with HIV, capacity-building of MSM community organizations and

  13. Willingness to participate in HIV vaccine trials among men who have sex with men in Chennai and Mumbai, India: a social ecological approach.

    Directory of Open Access Journals (Sweden)

    Venkatesan Chakrapani

    Full Text Available Recruitment of low- and middle-income country volunteers from most-at-risk populations in HIV vaccine trials is essential to vaccine development. In India, men who have sex with men (MSM are at disproportionately high risk for HIV infection and an important population for trial recruitment. Investigations of willingness to participate (WTP in HIV vaccine trials have focused predominantly on individual-level determinants. We explored multi-level factors associated with WTP among MSM in India.We conducted 12 focus groups (n = 68 with low socioeconomic MSM in Chennai and Mumbai, and 14 key informant interviews with MSM community leaders and service providers. Focus groups/interviews were recorded, transcribed and translated into English. Two bilingual investigators conducted thematic analysis using line-by-line coding and a constant comparative method, with member-checking by community representatives.Factors associated with WTP were evidenced across the social ecology of MSM-social-structural: poverty, HIV-, sexual- and gender non-conformity stigma, institutionalized discrimination and government sponsorship of trials; community-level: endorsement by MSM community leaders and organizations, and fear of within-group discrimination; interpersonal: anticipated family discord, partner rejection, having financially-dependent family members and disclosure of same-sex sexuality; and individual-level: HIV vaccine trial knowledge and misconceptions, safety concerns, altruism and preventive misconception.Pervasive familial, community and social-structural factors characteristic of the Indian sociocultural context may complicate individual-focused approaches to WTP and thereby constrain the effectiveness of interventions to support recruitment and retention in HIV vaccine trials. Interventions to reduce stigma and discrimination against MSM and people living with HIV, capacity-building of MSM community organizations and transparent communications tailored to

  14. Changes in Cardiovascular Disease Risk Factors With Immediate Versus Deferred Antiretroviral Therapy Initiation Among HIV-Positive Participants in the START (Strategic Timing of Antiretroviral Treatment) Trial

    DEFF Research Database (Denmark)

    Baker, Jason V; Sharma, Shweta; Achhra, Amit C

    2017-01-01

    INTRODUCTION: HIV infection and certain antiretroviral therapy (ART) medications increase atherosclerotic cardiovascular disease risk, mediated, in part, through traditional cardiovascular disease risk factors. METHODS AND RESULTS: We studied cardiovascular disease risk factor changes in the START...... (Strategic Timing of Antiretroviral Treatment) trial, a randomized study of immediate versus deferred ART initiation among HIV-positive persons with CD4+ cell counts >500 cells/mm3. Mean change from baseline in risk factors and the incidence of comorbid conditions were compared between groups....... The characteristics among 4685 HIV-positive START trial participants include a median age of 36 years, a CD4 cell count of 651 cells/mm3, an HIV viral load of 12 759 copies/mL, a current smoking status of 32%, a median systolic/diastolic blood pressure of 120/76 mm Hg, and median levels of total cholesterol of 168 mg...

  15. Lung cancer incidence and mortality in National Lung Screening Trial participants who underwent low-dose CT prevalence screening: a retrospective cohort analysis of a randomised, multicentre, diagnostic screening trial.

    Science.gov (United States)

    Patz, Edward F; Greco, Erin; Gatsonis, Constantine; Pinsky, Paul; Kramer, Barnett S; Aberle, Denise R

    2016-05-01

    Annual low-dose CT screening for lung cancer has been recommended for high-risk individuals, but the necessity of yearly low-dose CT in all eligible individuals is uncertain. This study examined rates of lung cancer in National Lung Screening Trial (NLST) participants who had a negative prevalence (initial) low-dose CT screen to explore whether less frequent screening could be justified in some lower-risk subpopulations. We did a retrospective cohort analysis of data from the NLST, a randomised, multicentre screening trial comparing three annual low-dose CT assessments with three annual chest radiographs for the early detection of lung cancer in high-risk, eligible individuals (aged 55-74 years with at least a 30 pack-year history of cigarette smoking, and, if a former smoker, had quit within the past 15 years), recruited from US medical centres between Aug 5, 2002, and April 26, 2004. Participants were followed up for up to 5 years after their last annual screen. For the purposes of this analysis, our cohort consisted of all NLST participants who had received a low-dose CT prevalence (T0) screen. We determined the frequency, stage, histology, study year of diagnosis, and incidence of lung cancer, as well as overall and lung cancer-specific mortality, and whether lung cancers were detected as a result of screening or within 1 year of a negative screen. We also estimated the effect on mortality if the first annual (T1) screen in participants with a negative T0 screen had not been done. The NLST is registered with ClinicalTrials.gov, number NCT00047385. Our cohort consisted of 26 231 participants assigned to the low-dose CT screening group who had undergone their T0 screen. The 19 066 participants with a negative T0 screen had a lower incidence of lung cancer than did all 26 231 T0-screened participants (371·88 [95% CI 337·97-408·26] per 100 000 person-years vs 661·23 [622·07-702·21]) and had lower lung cancer-related mortality (185·82 [95% CI 162·17

  16. The experience of patients participating in a small randomised control trial that explored two different interventions to reduce anxiety prior to an MRI scan.

    Science.gov (United States)

    Tugwell-Allsup, J; Pritchard, A W

    2018-05-01

    This paper reports qualitative findings from within a larger randomised control trial where a video clip or telephone conversation with a radiographer was compared to routine appointment letter and information sheet to help alleviate anxiety prior to their MRI scan. Questionnaires consisting of three free-text response questions were administered to all of the 74 patients recruited to the MRI anxiety clinical trial. The questionnaire was designed to establish patients' experiences of the intervention they had received. These questionnaires were administered post-scan. Two participants from each trial arm were also interviewed. A thematic approach was utilised for identifying recurrent categories emerging from the qualitative data which are supported by direct quotations. Participants in the interventional groups commented positively about the provision of pre-MRI scan information they received and this was contrastable with the relatively indifferent responses observed among those who received the standard information letter. Many important themes were identified including the patients needs for clear and simplified information, the experience of anticipation when waiting for the scan, and also the informally acquired information about having an MRI scan i.e. the shared experiences of friends and family. All themes highlighted the need for an inclusive and individually tailored approach to pre-scan information provision. Qualitative data collected throughout the trial is supportive of the statistical findings, where it is asserted that the use of a short video clip or a radiographer having a short conversation with patients before their scan reduces pre-scan anxiety. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  17. The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial.

    Science.gov (United States)

    Frandsen, Mai; Thow, Megan; Ferguson, Stuart G

    2016-08-10

    Recruiting participants for research studies can be difficult and costly. The popularity of social media platforms (eg, Facebook) has seen corresponding growth in the number of researchers turning to social networking sites and their embedded advertising frameworks to locate eligible participants for studies. Compared with traditional recruitment strategies such as print media, social media advertising has been shown to be favorable in terms of its reach (especially with hard-to-reach populations), cost effectiveness, and usability. However, to date, no studies have examined how participants recruited via social media progress through a study compared with those recruited using more traditional recruitment strategies. (1) Examine whether visiting the study website prior to being contacted by researchers creates self-screened participants who are more likely to progress through all study phases (eligible, enrolled, completed); (2) compare conversion percentages and cost effectiveness of each recruitment method at each study phase; and, (3) compare demographic and smoking characteristics of participants recruited through each strategy to determine if they attract similar samples. Participants recruited to a smoking cessation clinical trial were grouped by how they had become aware of the study: via social media (Facebook) or traditional media (eg, newspaper, flyers, radio, word of mouth). Groups were compared based on throughput data (conversion percentages and cost) as well as demographic and smoking characteristics. Visiting the study website did not result in individuals who were more likely to be eligible for (P=.24), enroll in (P=.20), or complete (P=.25) the study. While using social media was more cost effective than traditional methods when we examined earlier endpoints of the recruitment process (cost to obtain a screened respondent: AUD $22.73 vs $29.35; cost to obtain an eligible respondent: $37.56 vs $44.77), it was less cost effective in later endpoints

  18. The Building Wealth and Health Network: methods and baseline characteristics from a randomized controlled trial for families with young children participating in temporary assistance for needy families (TANF).

    Science.gov (United States)

    Sun, Jing; Patel, Falguni; Kirzner, Rachel; Newton-Famous, Nijah; Owens, Constance; Welles, Seth L; Chilton, Mariana

    2016-07-16

    Families with children under age six participating in the Temporary Assistance for Needy Families Program (TANF) must participate in work-related activities for 20 h per week. However, due to financial hardship, poor health, and exposure to violence and adversity, families may experience great difficulty in reaching self-sufficiency. The purpose of this report is to describe study design and baseline findings of a trauma-informed financial empowerment and peer support intervention meant to mitigate these hardships. We conducted a randomized controlled trial of a 28-week intervention called Building Wealth and Health Network to improve financial security and maternal and child health among caregivers participating in TANF. Participants, recruited from County Assistance offices in Philadelphia, PA, were randomized into two intervention groups (partial and full) and one control group. Participants completed questionnaires at baseline to assess career readiness, economic hardship, health and wellbeing, exposure to adversity and violence, and interaction with criminal justice systems. Baseline characteristics demonstrate that among 103 participants, there were no significant differences by group. Mean age of participants was 25 years, and youngest child was 30 months. The majority of participants were women (94.2 %), never married (83.5 %), unemployed (94.2 %), and without a bank account (66.0 %). Many reported economic hardship (32.0 % very low household food secure, 65.0 % housing insecure, and 31.1 % severe energy insecure), and depression (57.3 %). Exposure to adversity was prevalent, where 38.8 % reported four or more Adverse Childhood Experiences including abuse, neglect and household dysfunction. In terms of community violence, 64.7 % saw a seriously wounded person after an incident of violence, and 27.2 % had seen someone killed. Finally, 14.6 % spent time in an adult correctional institution, and 48.5 % of the fathers of the youngest child spent

  19. The relationship between BMI and insulin resistance and progression from single to multiple autoantibody positivity and type 1 diabetes among TrialNet Pathway to Prevention participants.

    Science.gov (United States)

    Meah, Farah A; DiMeglio, Linda A; Greenbaum, Carla J; Blum, Janice S; Sosenko, Jay M; Pugliese, Alberto; Geyer, Susan; Xu, Ping; Evans-Molina, Carmella

    2016-06-01

    The incidence of type 1 diabetes is increasing at a rate of 3-5% per year. Genetics cannot fully account for this trend, suggesting an influence of environmental factors. The accelerator hypothesis proposes an effect of metabolic factors on type 1 diabetes risk. To test this in the TrialNet Pathway to Prevention (PTP) cohort, we analysed the influence of BMI, weight status and insulin resistance on progression from single to multiple islet autoantibodies (Aab) and progression from normoglycaemia to diabetes. HOMA1-IR was used to estimate insulin resistance in Aab-positive PTP participants. Cox proportional hazards models were used to evaluate the effects of BMI, BMI percentile (BMI%), weight status and HOMA1-IR on the progression of autoimmunity or the development of diabetes. Data from 1,310 single and 1,897 multiple Aab-positive PTP participants were included. We found no significant relationships between BMI, BMI%, weight status or HOMA1-IR and the progression from one to multiple Aabs. Similarly, among all Aab-positive participants, no significant relationships were found between BMI, weight status or HOMA1-IR and progression to diabetes. Diabetes risk was modestly increased with increasing BMI% among the entire cohort, in obese participants 13-20 years of age and with increasing HOMA1-IR in adult Aab-positive participants. Analysis of the accelerator hypothesis in the TrialNet PTP cohort does not suggest a broad influence of metabolic variables on diabetes risk. Efforts to identify other potentially modifiable environmental factors should continue.

  20. Sexually Transmitted Infections in Women Participating in a Biomedical Intervention Trial in Durban: Prevalence, Coinfections, and Risk Factors.

    Science.gov (United States)

    Abbai, Nathlee Samantha; Wand, Handan; Ramjee, Gita

    2013-01-01

    Background. Sexually transmitted infections (STIs) continue to be a significant public health problem especially among women of reproductive age in Africa. Methods. A total of 2236 women that had enrolled in the MDP301 vaginal microbicide trial were tested for the presence of Chlamydia trachomatis (CT), Neisseria gonorrhea (NG), Treponema pallidum, and Trichomonas vaginalis (TV). Results. CT was identified as the most prevalent STI (11%) followed by TV (10%), NG, and Syphilis (3%). The highest prevalence of coinfection was reported between T. pallidum and TV (19.67%, P = 0.004), followed by CT and TV (13.52%, P ≤ 0.001). Risk factors that were significantly associated with STI acquisition were women of 23 years of age or younger (HR: 1.50, 95% CI 1.17, 1.93), baseline STI with CT (HR: 1.77, 95% CI 1.32, 2.35), TV (HR: 1.58, 95% CI, 1.20, 2.10), and T. pallidum (HR: 5.13, 95% CI 3.65, 7.22), and a low education level (HR: 1.30, 95% CI 1.02, 1.66). Conclusion. Young women with lower education and a history of STIs are at high risk of multiple STIs. Prevention programs should consider target approach to STI prevention among young women. This trial is registered with ISRCTN64716212.

  1. Bone mineral density during pregnancy in women participating in a randomized controlled trial of vitamin D supplementation.

    Science.gov (United States)

    Wei, Wei; Shary, Judith R; Garrett-Mayer, Elizabeth; Anderson, Betsy; Forestieri, Nina E; Hollis, Bruce W; Wagner, Carol L

    2017-12-01

    Background: Little is known about bone mineral density (BMD) during pregnancy. Advances in technology with lower radiation emissions by dual-energy X-ray absorptiometry instruments now permit the safe measurement of BMD during pregnancy. Objective: We evaluated maternal BMD during pregnancy as a function of vitamin D status in women of diverse racial/ethnic backgrounds. Design: A total of 301 women who underwent BMD measurements at 12-20 wk of gestation and again at 0-14 wk postpartum were included in this analysis. Women were a subset of subjects who were recruited for a randomized, controlled, double-blind trial of vitamin D supplementation in pregnancy (400, 2000, or 4000 IU/d). Results: Treatment had no significant effect on changes in BMD that occurred between 12-20 wk of gestation and 0-14 wk postpartum. Similarly, changes in spine and femoral neck bone mineral contents (BMCs) were not significantly different in the treatment groups. In addition, vitamin D inadequacy (serum 25-hydroxyvitamin D concentration, averaged across pregnancy, vitamin D supplementation on bone health and suggest that race/ethnicity and BMI play an important role in pregnancy bone health. This trial was registered at clinicaltrials.gov as NCT00292591. © 2017 American Society for Nutrition.

  2. Developing and managing a team to participate in trials involving acute respiratory failure: advice for the inexperienced.

    Science.gov (United States)

    Arabi, Yaseen; Ahmed, Qanta A

    2006-02-01

    Conducting large-scale clinical trials in the field of acute respiratory failure requires substantial collaboration. Teamwork is still in its infancy within the realm of clinical research. This review evaluates the need for and grassroots process of teamwork and considers the challenges facing teamwork in the specific context of conducting acute respiratory failure research today. Acute respiratory failure research demands complex, interdependent tasks, dictating a teamwork approach. The team is comprised of a sponsor, a leader and members. The sponsor provides essential administrative support, the leader performs many of the functions of a traditional manager in addition to adopting three distinct roles of initiator, role model and coach, and members are selected not only on their technical expertise, but also on their problem-solving and interpersonal skills. As large-scale (oftentimes international) multicenter trials are increasingly providing answers to our research questions, greater emphasis must be placed on team building within the clinical research environment. An urgent need for further work in this area is revealed. Critical care fellowships should integrate teamwork skills into the curriculum.

  3. Speak fast, use jargon, and don't repeat yourself: a randomized trial assessing the effectiveness of online videos to supplement emergency department discharge instructions.

    Directory of Open Access Journals (Sweden)

    Clare L Atzema

    Full Text Available Emergency department discharge instructions are variably understood by patients, and in the setting of emergency department crowding, innovations are needed to counteract shortened interaction times with the physician. We evaluated the effect of viewing an online video of diagnosis-specific discharge instructions on patient comprehension and recall of instructions.In this prospective, single-center, randomized controlled trial conducted between November 2011 and January 2012, we randomized emergency department patients who were discharged with one of 38 diagnoses to either view (after they left the emergency department a vetted online video of diagnosis-specific discharge instructions, or to usual care. Patients were subsequently contacted by telephone and asked three standardized questions about their discharge instructions; one point was awarded for each correct answer. Using an intention-to-treat analysis, differences between groups were assessed using univariate testing, and with logistic regression that accounted for clustering on managing physician. A secondary outcome measure was patient satisfaction with the videos, on a 10-point scale.Among 133 patients enrolled, mean age was 46.1 (s.d.D. 21.5 and 55% were female. Patients in the video group had 19% higher mean scores (2.5, s.d. 0.7 than patients in the control group (2.1, s.d. 0.8 (p=0.002. After adjustment for patient age, sex, first language, triage acuity score, and clustering, the odds of achieving a fully correct score (3 out of 3 were 3.5 (95% CI, 1.7 to 7.2 times higher in the video group, compared to the control group. Among those who viewed the videos, median rating of the videos was 10 (IQR 8 to 10.In this single-center trial, patients who viewed an online video of their discharge instructions scored higher on their understanding of key concepts around their diagnosis and subsequent care. Those who viewed the videos found them to be a helpful addition to standard care.ClinicalTrials

  4. Speak fast, use jargon, and don't repeat yourself: a randomized trial assessing the effectiveness of online videos to supplement emergency department discharge instructions.

    Science.gov (United States)

    Atzema, Clare L; Austin, Peter C; Wu, Libo; Brzozowski, Michael; Feldman, Michael J; McDonnell, Michael; Mazurik, Laurie

    2013-01-01

    Emergency department discharge instructions are variably understood by patients, and in the setting of emergency department crowding, innovations are needed to counteract shortened interaction times with the physician. We evaluated the effect of viewing an online video of diagnosis-specific discharge instructions on patient comprehension and recall of instructions. In this prospective, single-center, randomized controlled trial conducted between November 2011 and January 2012, we randomized emergency department patients who were discharged with one of 38 diagnoses to either view (after they left the emergency department) a vetted online video of diagnosis-specific discharge instructions, or to usual care. Patients were subsequently contacted by telephone and asked three standardized questions about their discharge instructions; one point was awarded for each correct answer. Using an intention-to-treat analysis, differences between groups were assessed using univariate testing, and with logistic regression that accounted for clustering on managing physician. A secondary outcome measure was patient satisfaction with the videos, on a 10-point scale. Among 133 patients enrolled, mean age was 46.1 (s.d.D. 21.5) and 55% were female. Patients in the video group had 19% higher mean scores (2.5, s.d. 0.7) than patients in the control group (2.1, s.d. 0.8) (p=0.002). After adjustment for patient age, sex, first language, triage acuity score, and clustering, the odds of achieving a fully correct score (3 out of 3) were 3.5 (95% CI, 1.7 to 7.2) times higher in the video group, compared to the control group. Among those who viewed the videos, median rating of the videos was 10 (IQR 8 to 10). In this single-center trial, patients who viewed an online video of their discharge instructions scored higher on their understanding of key concepts around their diagnosis and subsequent care. Those who viewed the videos found them to be a helpful addition to standard care. ClinicalTrials

  5. A cross-sectional study of the magnitude, barriers, and outcomes of HIV status disclosure among women participating in a perinatal HIV transmission study, "the Nevirapine Repeat Pregnancy study".

    Science.gov (United States)

    Kiweewa, Flavia M; Bakaki, Paul M; McConnell, Michelle S; Musisi, Maria; Namirembe, Constance; Nakayiwa, Frances; Kusasira, Fiona; Nakintu, Dorothy; Mubiru, Michael C; Musoke, Philippa; Fowler, Mary Glenn

    2015-09-29

    HIV status disclosure is a difficult emotional task for HIV-infected persons and may create the opportunity for both social support and rejection. In this study, we evaluated the proportions, patterns, barriers and outcomes of HIV- 1 status disclosure among a group of women in Uganda. An exit interview was conducted one year post-partum for 85 HIV-infected women who participated in a study of HIV-1 transmission rates among NVP-experienced compared with NVP-naïve women in "The Nevirapine Repeat Pregnancy (NVP-RP) Study" at the Makerere University-Johns Hopkins University Research Collaboration, Kampala-Uganda, between June 2004 and June 2006. Of the 85 women interviewed, 99 % had disclosed their HIV status to at least one other person. Disclosure proportions ranged between 1 % to employer(s) and 69 % to a relative other than a parent. Only 38 % of the women had disclosed to their sex partners. Women with an HIV-infected baby were more likely than those with an uninfected baby to disclose to their sex partner, OR 4.9 (95 % CI, 2.0 -11.2), and women were less likely to disclose to a partner if they had previously disclosed to another relative than if they had not, OR 0.19 (95 % CI, 0.14-0.52). The most common reasons for non-disclosure included fear of separation from the partner and subsequent loss of financial support 34 %, and not living with the partner (not having opportunities to disclose) 26 %. While most women (67 %) reported getting social support following disclosure, 22 % reported negative outcomes (neglect, separation from their partners, and loss of financial support). Following disclosure of HIV status, 9 % of women reported that their partner (s) decided to have an HIV test. Results from this study show high overall HIV disclosure proportions and how this disclosure of HIV status can foster social support. However, proportions of disclosure specifically to male sex partners were low, which suggests the need for interventions aimed at increasing male

  6. Are participants concerned about privacy and security when using short message service to report product adherence in a rectal microbicide trial?

    Science.gov (United States)

    Giguere, Rebecca; Brown, William; Balán, Ivan C; Dolezal, Curtis; Ho, Titcha; Sheinfil, Alan; Ibitoye, Mobolaji; Lama, Javier R; McGowan, Ian; Cranston, Ross D; Carballo-Diéguez, Alex

    2018-04-01

    During a Phase 2 rectal microbicide trial, men who have sex with men and transgender women (n = 187) in 4 countries (Peru, South Africa, Thailand, United States) reported product use daily via short message service (SMS). To prevent disclosure of study participation, the SMS system program included privacy and security features. We evaluated participants' perceptions of privacy while using the system and acceptability of privacy/security features. To protect privacy, the SMS system: (1) confirmed participant availability before sending the study questions, (2) required a password, and (3) did not reveal product name or study participation. To ensure security, the system reminded participants to lock phone/delete messages. A computer-assisted self-interview (CASI), administered at the final visit, measured burden of privacy and security features and SMS privacy concerns. A subsample of 33 participants underwent an in-depth interview (IDI). Based on CASI, 85% had no privacy concerns; only 5% were very concerned. Most were not bothered by the need for a password (73%) or instructions to delete messages (82%). Based on IDI, reasons for low privacy concerns included sending SMS in private or feeling that texting would not draw attention. A few IDI participants found the password unnecessary and more than half did not delete messages. Most participants were not concerned that the SMS system would compromise their confidentiality. SMS privacy and security features were effective and not burdensome. Short ID-related passwords, ambiguous language, and reminders to implement privacy and security-enhancing behaviors are recommended for SMS systems.

  7. The effectiveness of a physical activity stimulation programme for children with cerebral palsy on social participation, self-perception and quality of life: a randomized controlled trial.

    Science.gov (United States)

    Van Wely, Leontien; Balemans, Astrid Cj; Becher, Jules G; Dallmeijer, Annet J

    2014-10-01

    To determine the effects of a six-month physical activity stimulation programme on social participation, self-perception and quality of life in children with cerebral palsy. Multicentre randomized controlled trial with concealed allocation, blinded assessments and intention-to-treat analysis. Paediatric physiotherapy practices, special schools for children with a disability, and the child's own home. Forty-nine children with spastic cerebral palsy (28 male), aged 7-13 years, able to walk with and without walking aids. The intervention group followed a six-month physical activity stimulation programme involving counselling through motivational interviewing, home-based physiotherapy and four months of fitness training. The control group continued regular paediatric physiotherapy. Outcomes included social participation in domestic life, social participation in recreation and leisure (Life-Habits for Children questionnaire and Children's Assessment of Participation and Enjoyment questionnaire), self-perception (Harter's Self-Perception Profile for Children) and parent-reported quality of life (Cerebral Palsy Quality of Life Questionnaire). Assessments were performed at baseline, at six months (except quality of life) and at twelve months. Intervention resulted in a positive effect on social participation in domestic life at twelve months (mean between-group difference = 0.9, 95% confidence interval (CI) = 0.1 to 1.7 [1-10 scale], P = 0.03), but not at six months. No significant effects were found for social participation in recreation and leisure, self-perception at six months and twelve months or for quality of life at twelve months. The combination of counselling, home-based physiotherapy and fitness training was not effective in improving social participation in recreation and leisure, self-perception or quality of life, but did show a potential for improving social participation in domestic life over the longer term. © The Author(s) 2013.

  8. Role of Informed Consent in a Decision-making on Participation in The Clinical Trial: Multicenter study in Russia “Face to Face”

    Directory of Open Access Journals (Sweden)

    O. I. Zvonareva

    2016-01-01

    Full Text Available Introduction. Currently, clinical trials (CT remain the only technology, which provides proof of efficacy and safety of new drugs and their subsequent release to the market. Medical researcher and informed consent (IC are the main (and often the only source of information for the patient about the upcoming clinical trials, and thus have a direct impact on the perception of clinical trials, and on the patient’s decision about participation. However, the degree of influence of these factors on the clinical trials participants still remains unclear.Materials and methods. A multicenter cross-sectional study was conducted in different cities of the Russian Federation. Patients who had previous experience in CTs (or were enrolled in a CT at the time of this study were asked to complete a questionnaire.Results. To assess the impact of researcher, all respondents were divided into 2 groups: patients that acquainted with IC in collaboration with the researcher, and the other group, which reviewed IC form independently. We evaluated the importance of the factors influencing the decision-making process on participation in clinical trials. According to our data, the most important factors were professional monitoring services (3,72 ± 1,00, regular condition monitoring (3,66 ± 0,98, and better medical care (3,62 ± 1,00. These factors were evaluated at significantly lower score by group of patients that acquainted with IC together with the researcher (3,55 ±0,94, vs 4,01 ± 0,90, p = 0,002; 3,52 ± 1,01 vs 3,87 ± 0,90, p = 0,040; 3,49 ± 0,94, vs 3,83 ± 1,06, p = 0,020 respectively. In assessing the factors that had negative impact on the interest in participating in a clinical trial, the most significant were risk of side effects (3,01 ± 1,27, study of new medication (2,68 ± 1,21, and the risk of getting into the placebo group (2,64 ± 1,34 (so-called “objective” risk factors. At the same time, risk of side effects and risk of

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

    Science.gov (United States)

    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 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 donations (p donation was 11% for hematocrit, 10% for hemoglobin concentration, 50% for ferritin, and 12% for RBC (p 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.

  10. Randomized, controlled, assessor-blind clinical trial to assess the efficacy of single- versus repeated-dose albendazole to treat ascaris lumbricoides, trichuris trichiura, and hookworm infection.

    Science.gov (United States)

    Adegnika, Ayola A; Zinsou, Jeannot F; Issifou, Saadou; Ateba-Ngoa, Ulysse; Kassa, Roland F; Feugap, Eliane N; Honkpehedji, Yabo J; Dejon Agobe, Jean-Claude; Kenguele, Hilaire M; Massinga-Loembe, Marguerite; Agnandji, Selidji T; Mordmüller, Benjamin; Ramharter, Michael; Yazdanbakhsh, Maria; Kremsner, Peter G; Lell, Bertrand

    2014-05-01

    In many regions where soil-transmitted helminth infections are endemic, single-dose albendazole is used in mass drug administration programs to control infections. There are little data on the efficacy of the standard single-dose administration compared to that of alternative regimens. We conducted a randomized, controlled, assessor-blinded clinical trial to determine the efficacies of standard and extended albendazole treatment against soil-transmitted helminth infection in Gabon. A total of 175 children were included. Adequate cure rates and egg reduction rates above 85% were found with a single dose of albendazole for Ascaris infection, 85% (95% confidence interval [CI], 73, 96) and 93.8% (CI, 87.6, 100), respectively, while two doses were necessary for hookworm infestation (92% [CI, 78, 100] and 92% [CI, 78, 100], respectively). However, while a 3-day regimen was not sufficient to cure Trichuris (cure rate, 83% [CI, 73, 93]), this regimen reduced the number of eggs up to 90.6% (CI, 83.1, 100). The rate ratios of two- and three-dose regimens compared to a single-dose treatment were 1.7 (CI, 1.1, 2.5) and 2.1 (CI, 1.5, 2.9) for Trichuris and 1.7 (CI, 1.0, 2.9) and 1.7 (CI, 1.0, 2.9) for hookworm. Albendazole was safe and well tolerated in all regimens. A single-dose albendazole treatment considerably reduces Ascaris infection but has only a moderate effect on hookworm and Trichuris infections. The single-dose option may still be the preferred regimen because it balances efficacy, safety, and compliance during mass drug administration, keeping in mind that asymptomatic low-level helminth carriage may also have beneficial effects. (This study has been registered at ClinicalTrials.gov under registration number NCT01192802.).

  11. A sense of security: Spouses’ experiences of participating in an orthopaedic case management intervention (the SICAM-trial)

    DEFF Research Database (Denmark)

    Bøttcher Berthelsen, Connie; Kristensson, Jimmie

    2017-01-01

    The aim of the study was to explore and describe spouses' experiences of participating in a case management intervention during older patients' fast-track programme having total hip replacement as well as which intervention elements they found useful. Data were collected through qualitative...

  12. Does aerobic training alleviate fatigue and improve societal participation in patients with multiple sclerosis? A randomized controlled trial.

    Science.gov (United States)

    Heine, Martin; Verschuren, Olaf; Hoogervorst, Erwin Lj; van Munster, Erik; Hacking, Hub Ga; Visser-Meily, Anne; Twisk, Jos Wr; Beckerman, Heleen; de Groot, Vincent; Kwakkel, Gert

    2017-10-01

    Evidence supporting the effectiveness of aerobic training, specific for fatigue, in severely fatigued patients with multiple sclerosis (MS) is lacking. To estimate the effectiveness of aerobic training on MS-related fatigue and societal participation in ambulant patients with severe MS-related fatigue. Patients ( N = 90) with severe MS-related fatigue were allocated to 16-week aerobic training or control intervention. Primary outcomes were perceived fatigue (Checklist Individual Strength (CIS20r) fatigue subscale) and societal participation. An improvement of ⩾8 points on the CIS20r fatigue subscale was considered clinically relevant. Outcomes were assessed by a blinded observer at baseline, 2, 4, 6 and 12 months. Of the 89 patients that started treatment (median Expanded Disability Status Scale (interquartile range), 3.0 (2.0-3.6); mean CIS20r fatigue subscale (standard deviation (SD)), 42.6 (8.0)), 43 received aerobic training and 46 received the control intervention. A significant post-intervention between-group mean difference (MD) on the CIS20r fatigue subscale of 4.708 (95% confidence interval (CI) = 1.003-8.412; p  = 0.014) points was found in favour of aerobic training that, however, was not sustained during follow-up. No effect was found on societal participation. Aerobic training in MS patients with severe fatigue does not lead to a clinically meaningful reduction in fatigue or societal participation when compared to a low-intensity control intervention.

  13. Knowledge, attitudes and decision-making preferences of men considering participation in the TROG RAVES Prostate Cancer Trial (TROG 08.03).

    Science.gov (United States)

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

    2016-04-01

    The RAVES (Trans-Tasman Radiation Oncology Group 08.03) randomised controlled trial (RCT), compares adjuvant radiotherapy with early salvage radiotherapy in men with high risk histopathological features at prostatectomy. The RAVES Decision Aid study evaluates the utility of a decision aid for men considering participation in the RAVES RCT. We report the RAVES Decision Aid study participants' attitudes and knowledge regarding RCTs, decision-making preferences and decisional-conflict. Baseline questionnaires assessed knowledge and attitudes towards RCTs and RAVES RCT. Sociodemographic and clinical predictors of knowledge were examined. Involvement in decision-making and difficulties with the decision-making process were assessed using validated tools. 127 men (median age=63years) were recruited through urologists (n=91) and radiation oncologists (n=36). Men preferred collaborative (35%) or semi-active (35%) decision-making roles. Most (>75%) felt the RAVES RCT was worthwhile and important with participation being wise. However, nearly half had high decisional-conflict regarding participation. Scores of objective knowledge regarding RCTs and RAVES RCT were low. Most men with high-risk histopathological features at prostatectomy desire active involvement in decision-making regarding further management. Despite positive attitudes towards RCTs and the RAVES RCT, there were gaps in knowledge and high decisional-conflict surrounding participation. Crown Copyright © 2016. Published by Elsevier Ireland Ltd. All rights reserved.

  14. An evidence-based walking program among older people with knee osteoarthritis: the PEP (participant exercise preference) pilot randomized controlled trial.

    Science.gov (United States)

    Loew, Laurianne; Brosseau, Lucie; Kenny, Glen P; Durand-Bush, Natalie; Poitras, Stéphane; De Angelis, Gino; Wells, George A

    2017-07-01

    Knee osteoarthritis is a common joint problem leading to an increase of pain and a loss of function in older individuals. The main objective of this study was to evaluate if a participant who was randomly assigned to his preferred group improved his adherence to an effective walking program compared to a participant who did not receive his preferred group. This was a 9-month pilot randomized clinical trial, based on a patient treatment preferences design. The 69 eligible participants had a diagnosis of knee osteoarthritis. Participants were randomized to one of two groups: a supervised community-based or unsupervised walking program, based on the Ottawa Panel guidelines. At 6 months, participants who expressed a preference, either for the supervised or unsupervised program, and who were assigned to their preferred choice of program showed significantly higher adherence to walking sessions (supervised 60.7 ± 12.3%, P walking program, while ensuring the maintenance of clinical benefits of walking, among older adults susceptible to avoid or not properly engage in physical activity.

  15. Regional differences in milk and complementary feeding patterns in infants participating in an international nutritional type 1 diabetes prevention trial.

    Science.gov (United States)

    Nucci, Anita M; Virtanen, Suvi M; Sorkio, Susa; Bärlund, Sonja; Cuthbertson, David; Uusitalo, Ulla; Lawson, Margaret L; Salonen, Marja; Berseth, Carol L; Ormisson, Anne; Lehtonen, Eveliina; Savilahti, Erkki; Becker, Dorothy J; Dupré, John; Krischer, Jeffrey P; Knip, Mikael; Åkerblom, Hans K

    2017-07-01

    Differences in breastfeeding, other milk feeding and complementary feeding patterns were evaluated in infants at increased genetic risk with and without maternal type 1 diabetes (T1D). The Trial to Reduce IDDM in the Genetically at Risk is an international nutritional primary prevention double-blinded randomized trial to test whether weaning to extensively hydrolyzed vs. intact cow's milk protein formula will decrease the development of T1D-associated autoantibodies and T1D. Infant diet was prospectively assessed at two visits and seven telephone interviews between birth and 8 months. Countries were grouped into seven regions: Australia, Canada, Northern Europe, Southern Europe, Central Europe I, Central Europe II and the United States. Newborn infants with a first-degree relative with T1D and increased human leukocyte antigen-conferred susceptibility to T1D were recruited. A lower proportion of infants born to mothers with than without T1D were breastfed until 6 months of age in all regions (range, 51% to 60% vs. 70% to 80%). Complementary feeding patterns differed more by region than by maternal T1D. In Northern Europe, a higher proportion of infants consumed vegetables and fruits daily compared with other regions. Consumption of meat was more frequent in all European regions, whereas cereal consumption was most frequent in Southern Europe, Canada and the United States. Maternal T1D status was associated with breastfeeding and other milk feeding patterns similarly across regions but was unrelated to the introduction of complementary foods. Infant feeding patterns differed significantly among regions and were largely inconsistent with current recommended guidelines. © 2016 John Wiley & Sons Ltd.

  16. Design, and participant enrollment, of a randomized controlled trial evaluating effectiveness and cost-effectiveness of a community-based case management intervention, for patients suffering from COPD

    DEFF Research Database (Denmark)

    Sørensen, Sabrina Storgaard; Pedersen, Kjeld Møller; Weinreich, Ulla Møller

    2015-01-01

    Background: Case management interventions are recommended to improve quality of care and reduce costs in chronic care, but further evidence on effectiveness and cost-effectiveness is needed. The objective of this study is the reporting of the design and participant enrollment of a randomized...... controlled trial, conducted to evaluate the effectiveness and cost-effectiveness of a community-based case management model for patients suffering from chronic obstructive pulmonary disease (COPD). With a focus on support for self-care and care coordination, the intervention was hypothesized to result...... patients were randomized into two groups: the case-managed group and the usual-care group. Participant characteristics were obtained at baseline, and measures on effectiveness and costs were obtained through questionnaires and registries within a 12-month follow-up period. In the forthcoming analysis...

  17. From rehabilitation to recovery: protocol for a randomised controlled trial evaluating a goal-based intervention to reduce depression and facilitate participation post-stroke.

    Science.gov (United States)

    Graven, Christine; Brock, Kim; Hill, Keith; Ames, David; Cotton, Susan; Joubert, Lynette

    2011-06-18

    There is much discourse in healthcare about the importance of client-centred rehabilitation, however in the realm of community-based therapy post-stroke there has been little investigation into the efficacy of goal-directed practice that reflects patients' valued activities. In addition, the effect of active involvement of carers in such a rehabilitation process and their subsequent contribution to functional and emotional recovery post-stroke is unclear. In community based rehabilitation, interventions based on patients' perceived needs may be more likely to alter such outcomes. In this paper, we describe the methodology of a randomised controlled trial of an integrated approach to facilitating patient goal achievement in the first year post-stroke. The effectiveness of this intervention in reducing the severity of post-stroke depression, improving participation status and health-related quality of life is examined. The impact on carers is also examined. Patients (and their primary carers, if available) are randomly allocated to an intervention or control arm of the study. The intervention is multimodal and aims to screen for adverse stroke sequelae and address ways to enhance participation in patient-valued activities. Intervention methods include: telephone contacts, written information provision, home visitation, and contact with treating health professionals, with further relevant health service referrals as required. The control involves treatment as usual, as determined by inpatient and community rehabilitation treating teams. Formal blinded assessments are conducted at discharge from inpatient rehabilitation, and at six and twelve months post-stroke. The primary outcome is depression. Secondary outcome measures include participation and activity status, health-related quality of life, and self-efficacy. The results of this trial will assist with the development of a model for community-based rehabilitation management for stroke patients and their carers

  18. Impact of an Electronic Health Record-Integrated Personal Health Record on Patient Participation in Health Care: Development and Randomized Controlled Trial of MyHealthKeeper.

    Science.gov (United States)

    Ryu, Borim; Kim, Nari; Heo, Eunyoung; Yoo, Sooyoung; Lee, Keehyuck; Hwang, Hee; Kim, Jeong-Whun; Kim, Yoojung; Lee, Joongseek; Jung, Se Young

    2017-12-07

    Personal health record (PHR)-based health care management systems can improve patient engagement and data-driven medical diagnosis in a clinical setting. The purpose of this study was (1) to demonstrate the development of an electronic health record (EHR)-tethered PHR app named MyHealthKeeper, which can retrieve data from a wearable device and deliver these data to a hospital EHR system, and (2) to study the effectiveness of a PHR data-driven clinical intervention with clinical trial results. To improve the conventional EHR-tethered PHR, we ascertained clinicians' unmet needs regarding PHR functionality and the data frequently used in the field through a cocreation workshop. We incorporated the requirements into the system design and architecture of the MyHealthKeeper PHR module. We constructed the app and validated the effectiveness of the PHR module by conducting a 4-week clinical trial. We used a commercially available activity tracker (Misfit) to collect individual physical activity data, and developed the MyHealthKeeper mobile phone app to record participants' patterns of daily food intake and activity logs. We randomly assigned 80 participants to either the PHR-based intervention group (n=51) or the control group (n=29). All of the study participants completed a paper-based survey, a laboratory test, a physical examination, and an opinion interview. During the 4-week study period, we collected health-related mobile data, and study participants visited the outpatient clinic twice and received PHR-based clinical diagnosis and recommendations. A total of 68 participants (44 in the intervention group and 24 in the control group) completed the study. The PHR intervention group showed significantly higher weight loss than the control group (mean 1.4 kg, 95% CI 0.9-1.9; Phealth tracker system and its potential to improve patient clinical profiles. ClinicalTrials.gov NCT03200119; https://clinicaltrials.gov/ct2/show/NCT03200119 (Archived by WebCite at http

  19. Change in quality of life in older people with dementia participating in Paro-activity: a cluster-randomized controlled trial.

    Science.gov (United States)

    Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebaek, Camilla

    2016-12-01

    The aim of this study was to investigate effects of robot-assisted group activity with Paro on quality of life in older people with dementia. Nursing home residents with severe dementia often experience social withdrawal and lower quality of life, which are suggested to be enhanced by non-pharmacological interventions. A cluster-randomized controlled trial. Ten nursing home units were randomized to robot-assisted intervention or control group (treatment as usual). Data were collected between March 2013-September 2014. 27 participants participated in group activity for 30 minutes twice a week over 12 weeks, 26 participated in the control group. Change in quality of life was assessed by local nurses through the Quality of Life in Late-Stage Dementia scale at baseline, after end of intervention and at 3 months follow-up. The scale and regular psychotropic medication were analysed stratified by dementia severity. Analysis using mixed model, one-way anova and linear regression were performed. An effect was found among participants with severe dementia from baseline to follow-up showing stable quality of life in the intervention group compared with a decrease in the control group. The intervention explained most of the variance in change in the total scale and in the subscales describing Tension and Well-being for the group with severe dementia. The intervention group used significantly less psychotropic medication compared with the control group after end of intervention. Pleasant and engaging activities facilitated by nursing staff, such as group activity with Paro, could improve quality of life in people with severe dementia. The trial is in adherence with the CONSORT statement and is registered at www.clinicaltrials.gov (study ID number: NCT02008630). © 2016 John Wiley & Sons Ltd.

  20. Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT).

    Science.gov (United States)

    Issa, Omar M; Roberts, Rhonda; Mark, Daniel B; Boineau, Robin; Goertz, Christine; Rosenberg, Yves; Lewis, Eldrin F; Guarneri, Erminia; Drisko, Jeanne; Magaziner, Allan; Lee, Kerry L; Lamas, Gervasio A

    2018-01-01

    In a prespecified subgroup analysis of participants not on statin therapy at baseline in the TACT, a high-dose complex oral multivitamins and multimineral regimen was found to have a large unexpected benefit compared with placebo. The regimen tested was substantially different from any vitamin regimen tested in prior clinical trials. To explore these results, we performed detailed additional analyses of participants not on statins at enrollment in TACT. TACT was a factorial trial testing chelation treatments and a 28-component high-dose oral multivitamins and multiminerals regimen versus placebo in post-myocardial infarction (MI) patients 50 years or older. There were 460 (27%) of 1,708 TACT participants not taking statins at baseline, 224 (49%) were in the active vitamin group and 236 (51%) were in the placebo group. Patients were enrolled at 134 sites around the United States and Canada. Daily high-dose oral multivitamins and multiminerals (6 tablets, active or placebo). The primary end point of TACT was time to the first occurrence of any component of the composite end point: all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for angina. The primary end point occurred in 137 nonstatin participants (30%), of which 51 (23%) of 224 were in the active group and 86 (36%) of 236 were taking placebo (hazard ratio, 0.62; 95% confidence interval, 0.44-0.87; P=.006). Results in the key TACT secondary end point, a combination of cardiovascular mortality, stroke, or recurrent MI, was consistent in favoring the active vitamin group (hazard ratio, 0.46; 95% confidence interval, 0.28-0.75; P=.002). Multiple end point analyses were consistent with these results. High-dose oral multivitamin and multimineral supplementation seem to decrease combined cardiac events in a stable, post-MI population not taking statin therapy at baseline. These unexpected findings are being retested in the ongoing TACT2. Copyright © 2017 The Authors. Published by Elsevier

  1. An Online Health Prevention Intervention for Youth with Addicted or Mentally Ill Parents: Experiences and Perspectives of Participants and Providers from a Randomized Controlled Trial.

    Science.gov (United States)

    Woolderink, Marla; Bindels, Jill A P M; Evers, Silvia M A A; Paulus, Aggie T G; van Asselt, Antoinette D I; van Schayck, Onno C P

    2015-12-02

    Mental illnesses affect many people around the world, either directly or indirectly. Families of persons suffering from mental illness or addiction suffer too, especially their children. In the Netherlands, 864,000 parents meet the diagnostic criteria for a mental illness or addiction. Evidence shows that offspring of mentally ill or addicted parents are at risk for developing mental disorders or illnesses themselves. The Kopstoring course is an online 8-week group course with supervision by 2 trained psychologists or social workers, aimed to prevent behavioral and psychological problems for children (aged 16 to 25 years) of parents with mental health problems or addictions. The course addresses themes such as roles in the family and mastery skills. An online randomized controlled trial (RCT) was conducted to assess the effectiveness of the Kopstoring course. The aim was to gain knowledge about expectations, experiences, and perspectives of participants and providers of the online Kopstoring course. A process evaluation was performed to evaluate the online delivery of Kopstoring and the experiences and perspectives of participants and providers of Kopstoring. Interviews were performed with members from both groups. Participants were drawn from a sample from the Kopstoring RCT. Thirteen participants and 4 providers were interviewed. Five main themes emerged from these interviews: background, the requirements for the intervention, experience with the intervention, technical aspects, and research aspects. Overall, participants and providers found the intervention to be valuable because it was online; therefore, protecting their anonymity was considered a key component. Most barriers existed in the technical sphere. Additional barriers existed with conducting the RCT, namely gathering informed consent and gathering parental consent in the case of minors. This study provides valuable insight into participants' and providers' experiences and expectations with the online

  2. Testing decision-making competency of schizophrenia participants in clinical trials. A meta-analysis and meta-regression.

    Science.gov (United States)

    Hostiuc, Sorin; Rusu, Mugurel Constantin; Negoi, Ionut; Drima, Eduard

    2018-01-05

    The process of assessing the decision-making capacity of potential subjects before their inclusion in clinical trials is a legal requirement and a moral obligation, as it is essential for respecting their autonomy. This issue is especially important in psychiatry patients (such as those diagnosed with schizophrenia). The primary purpose of this article was to evaluate the degree of impairment in each dimension of decision-making capacity in schizophrenia patients compared to non-mentally-ill controls, as quantified by the (MacCAT-CR) instrument. Secondary objectives were (1) to see whether enhanced consent forms are associated with a significant increase in decision-making capacity in schizophrenia patients, and (2) if decision-making capacity in schizophrenia subjects is dependent on the age, gender, or the inpatient status of the subjects. We systematically reviewed the results obtained from three databases: ISI Web of Science, Pubmed, Scopus. Each database was scrutinised using the following keywords: "MacCAT-CR + schizophrenia", "decision-making capacity + schizophrenia", and "informed consent + schizophrenia." We included 13 studies in the analysis. The effect size between the schizophrenia and the control group was significant, with a difference in means of -4.43 (-5.76; -3.1, p reasoning, and -0.05 (-0.9, -0.01, p = 0.022) for expressing a choice. Even if schizophrenia patients have a significantly decreased decision-making capacity compared to non-mentally-ill controls, they should be considered as competent unless very severe changes are identifiable during clinical examination. Enhanced informed consent forms decrease the differences between schizophrenia patients and non-mentally-ill controls (except for the reasoning dimension) and should be used whenever the investigators want to include more ill patients in their clinical trials. Increased age, men gender and an increased percentage of inpatients might increase the differential of decision

  3. Who participates in a randomized trial of mindfulness-based stress reduction (MBSR) after breast cancer? A study of factors associated with enrollment among Danish breast cancer patients.

    Science.gov (United States)

    Würtzen, Hanne; Dalton, Susanne Oksbjerg; Andersen, Klaus Kaae; Elsass, Peter; Flyger, Henrik Lavlund; Sumbundu, Antonia; Johansen, Christoffer

    2013-05-01

    Discussion regarding the necessity to identify patients with both the need and motivation for psychosocial intervention is ongoing. Evidence for an effect of mindfulness-based interventions among cancer patients is based on few studies with no systematic enrollment. We used Danish population-based registries and clinical databases to determine differences in demographics, breast cancer and co-morbidity among 1208 women eligible for a randomized controlled trial (www.clinicaltrials.gov identifier: NCT00990977) of mindfulness-based stress reduction MBSR. Participants (N = 336) were found to be younger (p less recent diagnosis at invitation than decliners (N = 872; p statistically significant difference was also found between the two groups in use of psychologist sessions (p statistically significant differences in level of education, distress, anxiety, depression, well being and symptom burden. No differences were observed with regard to marital status, children living at home, affiliation to the work market, psychiatric caseness or any lifestyle measure. Our findings indicate that participants are younger, have a less recent diagnosis and have a higher level of education than those who refuse. This should be taken into account in designing and evaluating trials of psychosocial interventions and in planning mindfulness-based interventions. Copyright © 2012 John Wiley & Sons, Ltd.

  4. Neurological syndrome in an HIV-prevention trial participant randomized to daily tenofovir disoproxil fumarate (300 mg and emtricitabine (200 mg in Bondo, Kenya

    Directory of Open Access Journals (Sweden)

    Owino F

    2013-11-01

    Full Text Available Fredrick Owino,1 Justin Mandala,2 Julie Ambia,3 Kawango Agot,1 Lut Van Damme2 1Impact Research and Development Organization, Kisumu, Kenya; 2Department of Global Health, Population, and Nutrition, FHI 360, Washington, DC, USA; 3KAVI-Institute of Clinical Research, University of Nairobi, Nairobi, Kenya Abstract: Side effects of antiretroviral drug use by HIV-positive patients have been extensively studied; however, there are limited data on the side effects of antiretroviral drugs used as an HIV prophylaxis among healthy, HIV-negative individuals. Here we report on an unusual neuropathy in a 24-year-old participant in the FEM-PrEP trial. This was a Phase III randomized, double blind, placebo-controlled trial to test the safety and effectiveness of tenofovir disoproxil fumarate (300 mg and emtricitabine (200 mg (TDF-FTC to prevent HIV. At the eighth week of taking TDF-FTC with moderate adherence, the participant complained of mild paresthesiae, numbness, and a tingling sensation in her upper limbs that was associated with pain and cold. After an additional 4 days, she developed a disabling weakness of her upper limbs and tremors in her hands. The study product was discontinued, and within 2 weeks she was free of all symptoms. One month after restarting the drug, she complained of posture-dependent numbness of her upper limbs. Results of clinical and neurological exams, laboratory tests, and magnetic resonance imaging are described here. Keywords: pre-exposure prophylaxis, toxic neuropathy, NRTI

  5. A randomized clinical trial of diabetes self-management for Mexican Americans: Are there serendipitous health benefits for supporters of study participants?

    Directory of Open Access Journals (Sweden)

    Sharon A Brown

    2017-01-01

    Full Text Available Objectives: Studies of social support in diabetes have focused on the effects of support on the person with type 2 diabetes. We explored diabetes prevention effects of a culturally tailored diabetes self-management intervention in individuals without diabetes who were supporters of intervention participants. Methods: This is a secondary analysis of data from a randomized clinical trial that involved 256 Mexican Americans with diabetes. Each study participant designated a supporter—spouse, relative, friend—who attended intervention sessions and assisted participants in attaining effective diabetes self-management. Supporter’s glycosylated hemoglobin (A1C data were tracked for 1 year to determine diabetes conversion rates in supporters without diabetes at baseline. Results: Fewer individuals in the intervention group (n = 9 converted to an A1C above the 7% threshold, compared to the 1-year wait-listed control group (n = 16. We found a statistically significant difference (p = .021 at 12 months in the number of individuals whose A1C was ⩽8%, with fewer supporters above threshold in the intervention group (reduction of 48%. Supporters in the intervention group with prediabetes, based on baseline A1C, experienced a slight reduction in A1C, while control group supporters with prediabetes experienced an increase. Discussion: The results suggest that there are potential benefits for family members and other supporters of persons with diabetes who participated in diabetes self-management programs.

  6. Impact of Periodic Presumptive Treatment for Bacterial Vaginosis on the Vaginal Microbiome among Women Participating in the Preventing Vaginal Infections Trial.

    Science.gov (United States)

    Balkus, Jennifer E; Srinivasan, Sujatha; Anzala, Omu; Kimani, Joshua; Andac, Chloe; Schwebke, Jane; Fredricks, David N; McClelland, R Scott

    2017-03-01

    Evidence suggests that specific vaginal bacteria associated with bacterial vaginosis (BV) may increase the risk of adverse health outcomes in women. Among women participating in a randomized, double-blinded trial, we assessed the effect of periodic presumptive treatment (PPT) on detection of select vaginal bacteria. High-risk women from the United States and Kenya with a recent vaginal infection received intravaginal metronidazole 750 mg plus miconazole 200 mg or placebo for 5 consecutive nights each month for 12 months. Vaginal fluid specimens were collected via polyester/polyethylene terephthalate swabs every other month and tested for bacteria, using quantitative polymerase chain reaction (PCR) assays targeting the 16S ribosomal RNA gene. The effect of PPT on bacterium detection was assessed among all participants and stratified by country. Of 234 women enrolled, 221 had specimens available for analysis. The proportion of follow-up visits with detectable quantities was lower in the PPT arm versus the placebo arm for the following bacteria: BVAB1, BVAB2, Atopobium vaginae, Leptotrichia/Sneathia, and Megasphaera. The magnitude of reductions was greater among Kenyan participants as compared to US