Porter, Sam; McConnell, Tracey; Lynn, Fiona; McLaughlin, Katrina; Cardwell, Christopher; Holmes, Valerie
Failure to recruit sufficient numbers of participants to randomized controlled trials is a common and serious problem. This problem may be additionally acute in music therapy research. To use the experience of conducting a large randomized controlled trial of music therapy for young people with emotional and behavioral difficulties to illustrate the strategies that can be used to optimize recruitment; to report on the success or otherwise of those strategies; and to draw general conclusions about the most effective approaches. Review of the methodological literature, and a narrative account and realist analysis of the recruitment process. The strategies adopted led to the achievement of the recruitment target of 250 subjects, but only with an extension to the recruitment period. In the pre-protocol stage of the research, these strategies included the engagement of non-music therapy clinical investigators, and extensive consultation with clinical stakeholders. In the protocol development and initial recruitment stages, they involved a search of systematic reviews of factors leading to under-recruitment and of interventions to promote recruitment, and the incorporation of their insights into the research protocol and practices. In the latter stages of recruitment, various stakeholders including clinicians, senior managers and participant representatives were consulted in an attempt to uncover the reasons for the low recruitment levels that the research was experiencing. The primary mechanisms to promote recruitment are education, facilitation, audit and feedback, and time allowed. The primary contextual factors affecting the effectiveness of these mechanisms are professional culture and organizational support. © the American Music Therapy Association 2014. All rights reserved. For permissions, please e-mail: firstname.lastname@example.org.
Roschelle, Jeremy; Feng, Mingyu; Gallagher, H. Alix; Murphy, Robert; Harris, Christopher; Kamdar, Danae; Trinidad, Gucci
Recruitment is a key challenge for researchers conducting any large school-based study. Control is needed not only over the condition participants receive, but also over how the intervention is implemented, and may include restrictions in other areas of school and classroom functioning. We report here on our experiences in recruiting participants…
Burgess, Jacqueline D; Kimble, Roy M; Watt, Kerrianne; Cameron, Cate M
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.
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
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
Holm, Maja; Alvariza, Anette; Fürst, Carl-Johan; Wengström, Yvonne; Årestedt, Kristofer; Öhlen, Joakim; Goliath, Ida
The recruitment of participants to randomized controlled trials (RCTs) in palliative cancer care by health care professionals is often unsuccessful, which could result in failure to achieve study power. The purpose of this paper is to describe how health care professionals experienced recruiting patients and family caregivers to an RCT in palliative cancer care. The study had a qualitative explorative design. Ten palliative home care settings were involved in the RCT and data were generated through focus group discussions and interviews with health care professionals who were responsible for the recruitment. The transcripts were analyzed with interpretive descriptive principles. The experiences of the health care professionals reveal that communicating the RCT-design to patients and family caregivers was a challenging part of the recruitment but was considered a process of learning over time. The delicate situation that participants were living under added to the challenge and health care professionals believed that the randomized design was contrary to their normal approach to always offer the best possible support. The results contribute valuable knowledge for future trials in palliative cancer care. To promote successful recruitment, health care professionals may be in need of more training to improve their communication skills and it may be necessary to consider other research designs than the RCT. Copyright © 2017 Elsevier Ltd. All rights reserved.
Introduction Māori are disproportionately affected by cardiovascular disease (CVD), which is the main reason for the eight year difference in life expectancy between Māori and non-Māori. The primary care-based IMPACT (IMProving Adherence using Combination Therapy) trial evaluates whether fixed dose combination therapy (a “polypill”) improves adherence to guideline-based therapy compared with current care among people at high risk of CVD. Interventions shown in trials to be effective do not necessarily reduce ethnic disparities, and may in fact widen them. Indigenous populations with poorer health outcomes are often under-represented in trials so the effect of interventions cannot be assessed for them, specifically. Therefore, the IMPACT trial aimed to recruit as many Māori as non-Māori to assess the consistency of the effect of the polypill. This paper describes the methods and results of the recruitment strategy used to achieve this. Methods Experienced Māori researchers were involved in trial governance throughout trial development and conduct. The trial Steering Committee included leading Māori researchers and was committed to equal recruitment of Māori and non-Māori. Additional funding and Māori research nurses were sought to allow home-based assessment, establishment of the relationship between research nurse and participant, more family involvement prior to enrollment, continuity of the research nurse-participant relationship, and acknowledgement of other Māori culturally important procedures, interactions, language and manners. Primary care practices with high enrollment of Māori were targeted, with over-sampling of potentially eligible Māori patients, lower thresholds for screening of Māori and 6 months continued Māori recruitment after non-Māori recruitment had finished. Results A total of 257 Māori and 256 non-Māori participants were randomized. Four Māori and eight non-Māori participants were randomized per research nurse per
Barrera, Alinne Z; Kelman, Alex R; Muñoz, Ricardo F
One of the advantages of Internet-based research is the ability to efficiently recruit large, diverse samples of international participants. Currently, there is a dearth of information on the behind-the-scenes process to setting up successful online recruitment tools. The objective of the study was to examine the comparative impact of Spanish- and English-language keywords for a Google AdWords campaign to recruit pregnant women to an Internet intervention and to describe the characteristics of those who enrolled in the trial. Spanish- and English-language Google AdWords campaigns were created to advertise and recruit pregnant women to a Web-based randomized controlled trial for the prevention of postpartum depression, the Mothers and Babies/Mamás y Bebés Internet Project. Search engine users who clicked on the ads in response to keyword queries (eg, pregnancy, depression and pregnancy) were directed to the fully automated study website. Data on the performance of keywords associated with each Google ad reflect Web user queries from February 2009 to June 2012. Demographic information, self-reported depression symptom scores, major depressive episode status, and Internet use data were collected from enrolled participants before randomization in the intervention study. The Google ads received high exposure (12,983,196 impressions) and interest (176,295 clicks) from a global sample of Web users; 6745 pregnant women consented to participate and 2575 completed enrollment in the intervention study. Keywords that were descriptive of pregnancy and distress or pregnancy and health resulted in higher consent and enrollment rates (i.e., high-performing ads). In both languages, broad keywords (eg, pregnancy) had the highest exposure, more consented participants, and greatest cost per consent (up to US $25.77 per consent). The online ads recruited a predominantly Spanish-speaking sample from Latin America of Mestizo racial identity. The English-speaking sample was also diverse
Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W
Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or
Farquhar, Stephanie; de Jesus Gonzalez, Carmen; Hall, Jennifer; Samples, Julie; Ventura, Santiago; Sanchez, Valentin; Shadbeh, Nargess
There is limited information on the specific practices used to successfully recruit and retain indigenous and Latino farmworkers in research studies. This article describes the strategies used in a community-based participatory research project with indigenous agricultural workers. Participants were recruited through consulting with indigenous relatives and friends, identifying and meeting with indigenous leaders from hometown associations in countries of origin, and asking current participants to recruit fellow farmworkers. Adjustments were initiated to the second year protocol to enhance recruitment and retention. The difference in attrition rates between years one and two was statistically significant, a difference partially attributed to modifications to recruitment and retention protocol. Findings confirmed that active recruitment techniques and word-of-mouth recruitment were more effective than passive methods. Trust among academic, organization, and community partners, and shared language and culture between those doing the recruitment and the participants, contributed to sustained farmworker participation. PMID:23733354
Farquhar, Stephanie; de Jesus Gonzalez, Carmen; Hall, Jennifer; Samples, Julie; Ventura, Santiago; Sanchez, Valentin; Shadbeh, Nargess
There is limited information on the specific practices used to successfully recruit and retain indigenous and Latino farmworkers in research studies. This article describes the strategies used in a community-based participatory research project with indigenous agricultural workers. Participants were recruited through consulting with indigenous relatives and friends, identifying and meeting with indigenous leaders from hometown associations in countries of origin, and asking current participants to recruit fellow farmworkers. Adjustments were initiated to the second year protocol to enhance recruitment and retention. The difference in attrition rates between years one and two was statistically significant, a difference partially attributed to modifications to recruitment and retention protocol. Findings confirmed that active recruitment techniques and word-of-mouth recruitment were more effective than passive methods. Trust among academic, organization, and community partners, and shared language and culture between those doing the recruitment and the participants, contributed to sustained farmworker participation.
Full Text Available Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER study population. Potential study participants (age 60–77 years, the dementia risk score ≥6 were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496, 48% (n = 2654 attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1. The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD age of the randomized participants was 69.4 (4.7 years, Mini-Mental State Examination 26.7 (2.0 points, systolic blood pressure 140.1 (16.2 mmHg, total serum cholesterol 5.2 (1.0 mmol/L for, and fasting glucose 6.1 (0.9 mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons.
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
Frandsen, Mai; Thow, Megan; Ferguson, Stuart G.
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-re...
Cristina M. Caperchione
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.
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
Thow, Megan; Ferguson, Stuart G
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
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.
Frandsen, Mai; Thow, Megan; Ferguson, Stuart G
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
Gioia, Christopher J; Sobell, Linda Carter; Sobell, Mark B; Agrawal, Sangeeta
Technology has transformed our lifestyles in dramatic and significant ways, including new and less expensive options for recruiting study participants. This study examines cost and participant differences between two recruitment sources, Craigslist (CL), and print newspapers (PNs). This paper also reviewed and compared studies involving clinical trials published since 2010 that recruited participants using CL alone or in combination with other methods. Secondary data analyses from a parent study involving a randomized controlled trial of a mail-based intervention to promote self-change with problem drinkers. Significant differences were found between CL and PN participants on most demographic and pretreatment drinking variables. While all participants had AUDIT scores suggestive of an alcohol problem and reported drinking at high-risk levels, CL participants had less severe drinking problem histories, were considerably younger, and had a higher socioeconomic status than PN participants. The total advertising costs for the 65 CL ads ($275) were significantly less than the 69 PN ads ($33, 311). The recruiting cost per eligible participant was vastly less expensive using CL ($1.46) compared to print newspaper ads ($116.88). Using CL is a viable recruitment method for soliciting participants, particularly those that are younger, for alcohol intervention studies. It is also less expensive than newspaper ads. When CL participants were recruited, they reported being slightly more confident to change their drinking than PN participants. Limitations of using CL are discussed, including that some initial ad responders gave inconsistent answers to similar questions and a few tried to enter the study more than once. Copyright © 2015 Elsevier Ltd. All rights reserved.
Gul, Raisa B; Ali, Parveen A
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
Luck, Lauretta; Chok, Harrison Ng; Wilkes, Lesley
Recruitment and retention of participants, as well as response rates, can be challenging in nursing research. This can be because of the questions asked; the choice of methodology; the methods used to collect data; the characteristics of potential participants; the sample size required; and the duration of the study. Additionally, conducting research with nurses as participants presents several issues for them, including the time needed to participate in the research, the competing commitments for clinical practice, the political and environmental climate, and recruitment itself. To report on research studies conducted by the authors at a tertiary teaching hospital, to show the lessons learned when recruiting nurses to participate in nursing research. The authors discuss factors that supported recruitment of nurses in these studies, including the use of the personal touch and multiple recruitment strategies in a single study. Videos and photography facilitate interdisciplinary research and can be a valuable means of non-verbal data collection, especially with participants affected by disabilities, and can support research methods, such as the use of questionnaires. Recruiting nurses for research can be challenging. We suggest that researchers consider using more than one recruitment strategy when recruiting nurse participants. Recruitment is more successful if researchers align the aim(s) of the research with nurse's concerns and contexts. ©2012 RCN Publishing Company Ltd. All rights reserved. Not to be copied, transmitted or recorded in any way, in whole or part, without prior permission of the publishers.
Sugden, Nicole A.; Moulson, Margaret C.
Psychological and developmental research have been critiqued for the lack of diversity of research samples. Because differences in culture, race, and ethnicity can influence participant behavior, limited diversity limits the generalizability of the findings. These differences may also impact how participants behave in response to recruitment attempts, which suggests that recruitment itself may be leveraged to increase sample diversity. The goal of the current study was to determine what factors, within a recruitment interaction, could be leveraged to increase success and diversity when recruiting families with children for developmental research. Study 1 found three factors influenced success: (1) recruitment was more successful when other potential participants were also interested (i.e., recruiters were busy), (2) recruiters of particular races were more successful than recruiters of other races, and (3) differences in success were related to what the recruiter said to engage the potential participant (i.e., the script). The latter two factors interacted, suggesting some recruiters were using less optimal scripts. To improve success rates, study 2 randomly assigned scripts to recruiters and encouraged them to recruit more vigorously during busy periods. Study 2 found that two factors influenced success: (1) some scripts were more successful than others and (2) we were more successful at recruiting non-White potential participants than White participants. These two interacted, with some scripts being more successful with White and other scripts being more successful with non-White families. This intervention significantly increased recruitment success rate by 8.1% and the overall number of families recruited by 15.3%. These findings reveal that empirically evaluating and tailoring recruitment efforts based on the most successful strategies is effective in boosting diversity through increased participation of children from non-White families. PMID:25972829
Sugden, Nicole A; Moulson, Margaret C
Psychological and developmental research have been critiqued for the lack of diversity of research samples. Because differences in culture, race, and ethnicity can influence participant behavior, limited diversity limits the generalizability of the findings. These differences may also impact how participants behave in response to recruitment attempts, which suggests that recruitment itself may be leveraged to increase sample diversity. The goal of the current study was to determine what factors, within a recruitment interaction, could be leveraged to increase success and diversity when recruiting families with children for developmental research. Study 1 found three factors influenced success: (1) recruitment was more successful when other potential participants were also interested (i.e., recruiters were busy), (2) recruiters of particular races were more successful than recruiters of other races, and (3) differences in success were related to what the recruiter said to engage the potential participant (i.e., the script). The latter two factors interacted, suggesting some recruiters were using less optimal scripts. To improve success rates, study 2 randomly assigned scripts to recruiters and encouraged them to recruit more vigorously during busy periods. Study 2 found that two factors influenced success: (1) some scripts were more successful than others and (2) we were more successful at recruiting non-White potential participants than White participants. These two interacted, with some scripts being more successful with White and other scripts being more successful with non-White families. This intervention significantly increased recruitment success rate by 8.1% and the overall number of families recruited by 15.3%. These findings reveal that empirically evaluating and tailoring recruitment efforts based on the most successful strategies is effective in boosting diversity through increased participation of children from non-White families.
Nicole Andrea Sugden
Full Text Available Psychological and developmental research have been critiqued for the lack of diversity of research samples. Because differences in culture, race, and ethnicity can influence participant behavior, limited diversity limits the generalizability of the findings. These differences may also impact how participants behave in response to recruitment attempts, which suggests that recruitment itself may be leveraged to increase sample diversity. The goal of the current study was to determine what factors, within a recruitment interaction, could be leveraged to increase success and diversity when recruiting families with children for developmental research. Study 1 found three factors influenced success: 1 recruitment was more successful when other potential participants were also interested (i.e., recruiters were busy, 2 recruiters of particular races were more successful than recruiters of other races, and 3 differences in success were related to what the recruiter said to engage the potential participant (i.e., the script. The latter two factors interacted, suggesting some recruiters were using less optimal scripts. To improve success rates, study 2 randomly assigned scripts to recruiters and encouraged them to recruit more vigorously during busy periods. Study 2 found that two factors influenced success: 1 some scripts were more successful than others and 2 we were more successful at recruiting non-White potential participants than White participants. These two interacted, with some scripts being more successful with White and other scripts being more successful with non-White families. This intervention significantly increased recruitment success rate by 8.1% and the overall number of families recruited by 15.3%. These findings reveal that empirically evaluating and tailoring recruitment efforts based on the most successful strategies is effective in boosting diversity through increased participation of children from non-White families.
Each Screening Center was responsible for establishing its own procedures for identifying and recruiting participants into the trial based on guidelines disseminated by the Coordinating Center and developed by NCI. Each Screening Center was also encouraged to develop and use other materials, such as introductory letters and answers to FAQs, to assist with recruitments. Once potential participants had been identified, the Screening Center collected information about them to determine their eligibility for the trial. |
Walsh, Erin I; Brinker, Jay K
Despite being a common aspect of psychological research, the impact of delay between recruitment and active participation on dropout rates has received little research attention. This is probably due to the intuitive sense that longer delays will increase the dropout rate. Preinclusion attrition diminishes sample sizes and may threaten data representativeness. One hundred and two university undergraduates were recruited to participate in a short, one-off study via Short Message Service (SMS). Upon receipt of an SMS indicating consent to participate, the researchers delayed sending the study questions for one day, one week, one month, or two months. Delay was significantly associated with response rate with an 80% response rate in the one-day delay condition, 56% at one week, and 42% at one month. No responses were received in the two-month delay condition. This research confirms that the delay between recruitment and active participation impacts on preinclusion attrition when conducting research via SMS.
Parikh, Yasha; Mason, Maryann; Williams, Karen
Childhood obesity prevalence has tripled over the last three decades. Pediatric obesity has important implications for both adult health as well as the United States economy. In order to combat pediatric obesity, exploratory studies are necessary to create effective interventions. Recruitment is an essential part of any study, and it has been challenging for all studies, especially pediatric obesity studies. The objective of this study was to understand barriers to pediatric obesity study recruitment and review facilitators to overcome recruitment difficulties. Twenty four childhood obesity researchers were contacted. Complete data for 11 researchers were obtained. Interviews were transcribed and analyzed using content analysis. Grounded Theory methodological approach was used, as this was an exploratory study. Investigators YP and MM coded the interviews using 28 codes. Barriers to recruitment included: family and study logistics, family economics, lack of provider interest, invasive protocols, stigma, time restraints of clinicians, lack of patient motivation/interest, groupthink of students in a classroom, and participants who do not accept his or her own weight status. Facilitators to enhance recruitment practices included accommodating participants outside of regular clinic hours, incentivizing participants, cultivating relationships with communities, schools and clinics prior to study recruitment, emphasizing benefits of a study for the patient, and shifting language to focus on health rather than obesity. Pediatric obesity researchers face many standard and some unique challenges to recruitment, reflecting challenges common to clinical research as well as some specific to pediatrics and some specific to obesity research. Both pediatric studies as well as obesity studies are an added challenge to the already-difficult task of general study recruitment. Our findings can be used to make researchers more aware of potential difficulties, approaches and on
Foster Charlie E
Full Text Available Abstract Purpose Most researchers who are conducting physical activity trials face difficulties in recruiting participants who are representative of the population or from specific population groups. Participants who are often the hardest to recruit are often those who stand to benefit most (the least active, from ethnic and other minority groups, from neighbourhoods with high levels of deprivation, or have poor health. The aim of our study was to conduct a systematic review of published literature of walking interventions, in order to identify the impact, characteristics, and differential effects of recruitment strategies among particular population groups. Methods We conducted standard searches for studies from four sources, (i electronic literature databases and websites, (ii grey literature from internet sources, (iii contact with experts to identify additional "grey" and other literature, and (iv snowballing from reference lists of retrieved articles. Included studies were randomised controlled trials, controlled before-and-after experimental or observational qualitative studies, examining the effects of an intervention to encourage people to walk independently or in a group setting, and detailing methods of recruitment. Results Forty seven studies met the inclusion criteria. The overall quality of the descriptions of recruitment in the studies was poor with little detail reported on who undertook recruitment, or how long was spent planning/preparing and implementing the recruitment phase. Recruitment was conducted at locations that either matched where the intervention was delivered, or where the potential participants were asked to attend for the screening and signing up process. We identified a lack of conceptual clarity about the recruitment process and no standard metric to evaluate the effectiveness of recruitment. Conclusion Recruitment concepts, methods, and reporting in walking intervention trials are poorly developed, adding to
Krusche, Adele; Rudolf von Rohr, Isabelle; Muse, Kate; Duggan, Danielle; Crane, Catherine; Williams, J Mark G
Randomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties in recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited, and trials often fail to report sufficient details about the recruitment sources and resources utilized. We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression. We describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of (1) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial; (2) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants; and (3) comparison of sociodemographic characteristics of individuals recruited from different sources. Poster advertising, web-based advertising, and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters, and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important. It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations, such as those currently unwell, or in
Koziol-McLain, Jane; McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C
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
Nash, Erin L; Gilroy, Deborah; Srikusalanukul, Wichat; Abhayaratna, Walter P; Stanton, Tony; Mitchell, Geoffrey; Stowasser, Michael; Sharman, James E
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 < 0.05). There was also an increase in Tasmania that was of borderline significance (from 4.0 participants recruited/month to 9.3/month; P = 0.052). However, there was no effect in Queensland (from 6.0 participants recruited/month to 3.0/month; P = 0.15). Facebook advertisement was associated with a significant decrease in the age of participants enquiring into the study (from 60.9 to 58.7 years; P < 0.001). Facebook 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.
Helmerhorst Frans M
Full Text Available Abstract Background The usefulness of hysterosalpingography (HSG as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial. Methods All newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1 April 1997 and 31 December 1999, were eligible for the study. The reasons for non-participation were evaluated by scrutinizing the medical records. Results Out of 759 women, a total of 127 (17% agreed to participate in the trial. The most important reason for non-participation was because of exclusion criteria (73%. Other reasons were inattentive clinicians (3% and patient-associated reasons (24%. Patient refusal and indecisiveness to enroll in the study were the most common patient-associated reasons. The most frequently stated reason for trial refusal was reluctance to undergo laparoscopy and dye mainly due to issues related to anesthesia and scheduling of procedure. Conclusion Almost three-quarters of recruitment difficulties in this study were due to unavoidable reasons. To overcome the remaining avoidable reasons for non-participation, attention should be paid to appropriate instruction of the study protocol to the participating doctors and to provide adequate information, in layman's terms, to the patients. Reminding patients by notes or telephone calls for attending the clinic are helpful. It may be contingent upon tracing the reasons of clinicians and patients for non-participation to improve enrollment during a trial.
Gu, Yu-Mei; Thijs, Lutgarde; Li, Yan
Evidence-based thresholds for risk stratification based on pulse pressure (PP) are currently unavailable. To derive outcome-driven thresholds for the 24-hour ambulatory PP, we analyzed 9938 participants randomly recruited from 11 populations (47.3% women). After age stratification (<60 versus ≥60...
Carter, Anouska; Humphreys, Liam; Snowdon, Nicky; Sharrack, Basil; Daley, Amanda; Petty, Jane; Woodroofe, Nicola; Saxton, John
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
Oude Rengerink, Katrien; Kalkman, Shona; Collier, Susan; Ciaglia, Antonio; Worsley, Sally D; Lightbourne, Alison; Eckert, Laurent; Groenwold, Rolf H H; Grobbee, Diederick E; Irving, Elaine A
This paper addresses challenges of identifying, enrolling, and retaining participants in a trial conducted within a routine care setting. All patients who are potential candidates for the treatments in routine clinical practice should be considered eligible for a pragmatic trial. To ensure generalizability, the recruited sample should have a similar distribution of the treatment effect modifiers as the target population. In practice, this can be best achieved by including-within the selected sites-all patients without further selection. If relevant heterogeneity between subgroups is expected, increasing the relative proportion of the subgroup of patients in the heterogeneous trial could be considered (oversampling) or a separate trial in this subgroup can be planned. Selection will nevertheless occur. Low enrollment and loss to follow-up can introduce selection and can jeopardize validity as well as generalizability. Pragmatic trials are conducted in clinical practice rather than in a dedicated research setting, which could reduce recruitment rates. However, if a trial poses a minimal burden to the physician and the patient and routine clinical practice is maximally adhered to, the participation rate may be high and loss to follow-up will not be a specific problem for pragmatic trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Bhanushali, Minal J; Gustafson, Tarah; Powell, Steve; Conwit, Robin A; Wolinsky, Jerry S; Cutter, Gary R; Lublin, Fred D; Cofield, Stacey S
and purpose Participant recruitment is central to all clinical trials. Any delay in recruitment affects the completion and ultimate success of the trial. We report our experience with patient screening and randomization in CombiRx, which may inform the design of other trials. CombiRx was a multicenter, phase III, double-blind, randomized clinical trial comparing the combined use of interferon beta-1a and glatiramer acetate to either agent alone in patients with relapsing-remitting multiple sclerosis (RRMS). This trial was launched in January 2005 in 69 centers in the United States and Canada under a co-operative agreement with the National Institute of Neurological Disorders and Stroke (NINDS). The goal was to recruit 1000 patients over 1.5 years after a 6-month start-up period. Instead, the investigators required 4.25 years to enroll 1008 patients. During this trial, we assessed the effectiveness of various recruitment strategies, utility of rescreening prior screen failures, and potential factors and strategies used in study conduct, research, and infrastructure, all of which affected recruitment of participants and ultimately time to completion of CombiRx. We particularly were interested in the variability in time to site initiation between academic centers and private practice sites. Physicians who were directly involved in the medical care of patients with RRMS were the primary source of patients recruited to CombiRx. A flexible study design that allowed for rescreening of the initial screen failures after a period of time was useful due to the relapsing/remitting course of the disease. Academic centers took longer to implement the trial than the private practice centers, but once sites were approved for enrollment, there was no important difference in the number of participants enrolled. The CombiRx trial was conducted during a period when multiple new medications were being tested, thus affecting the pace of recruitment and limiting ability to generalize our
Gordon, Judith S; Akers, Laura; Severson, Herbert H; Danaher, Brian G; Boles, Shawn M
An estimated 22% of Americans currently use smokeless tobacco (ST). Most live in small towns and rural areas that offer few ST cessation resources. Approximately 94 million Americans use the Internet for health-related information, and on-line access is growing among lower-income and less-educated groups. As part of a randomized clinical trial to assess the reach and effectiveness of Web-based programs for delivering an ST cessation intervention, the authors developed and evaluated several methods for overcoming the recruitment challenges associated with Web-based research. This report describes and evaluates these methods. Participants were recruited through: (a) Thematic promotional "releases" to print and broadcast media, (b) Google ads, (c) placement of a link on other Web sites, (d) limited purchase of paid advertising, (e) direct mailings to ST users, and (f) targeted mailings to health care and tobacco control professionals. Combined recruitment activities resulted in more than 23,500 hits on our recruitment website from distinct IP addresses over 15 months, which yielded 2,523 eligible ST users who completed the registration process and enrolled in the study. Self-reports revealed that at least 1,276 (50.6%) of these participants were recruited via mailings, 874 (34.6%) from Google ads or via search engines or links on another Web site, and 373 (14.8%) from all other methods combined. The use of thematic mailings is novel in research settings. Recruitment of study participants went quickly and smoothly. Google ads and mailings to media outlets were the methods that recruited the highest number of participants.
Peter P. Groenewegen
Full Text Available Background. The participation of general practitioners (GPs is essential in research on the performance of primary care. This paper describes the implementation of a large, multicountry study in primary care that combines a survey among GPs and a linked survey among patients that visited their practice (the QUALICOPC study. The aim is to describe the recruitment procedure and explore differences between countries in the participation rate of the GPs. Methods. Descriptive analyses were used to document recruitment procedures and to assess hypotheses potentially explaining variation in participation rates between countries. Results. The survey was implemented in 31 European countries. GPs were mainly selected through random sampling. The actual implementation of the study differed between countries. The median participation rate was 30%. Both material (such as the payment system of GPs in a country and immaterial influences (such as estimated survey pressure are related to differences between countries. Conclusion. This study shows that the participation of GPs may indeed be influenced by the context of the country. The implementation of complex data collection is difficult to realize in a completely uniform way. Procedures have to be tuned to the context of the country.
Moreno, Megan A; Waite, Alan; Pumper, Megan; Colburn, Trina; Holm, Matt; Mendoza, Jason
Recruiting adolescent participants for research is challenging. The purpose of this study was to compare traditional in-person recruitment methods to social media recruitment. We recruited adolescents aged 14-18 years for a pilot physical activity intervention study, including a wearable physical activity tracking device and a Facebook group. Participants were recruited (a) in person from a local high school and an adolescent medicine clinic and (b) through social media, including Facebook targeted ads, sponsored tweets on Twitter, and a blog post. Data collected included total exposure (i.e., reach), engagement (i.e., interaction), and effectiveness. Effectiveness included screening and enrollment for each recruitment method, as well as time and resources spent on each recruitment method. In-person recruitment reached a total of 297 potential participants of which 37 enrolled in the study. Social media recruitment reached a total of 34,272 potential participants of which 8 enrolled in the study. Social media recruitment methods utilized an average of 1.6 hours of staff time and cost an average of $40.99 per participant enrolled, while in-person recruitment methods utilized an average of 0.75 hours of staff time and cost an average of $19.09 per participant enrolled. Social media recruitment reached more potential participants, but the cost per participant enrolled was higher compared to traditional methods. Studies need to consider benefits and downsides of traditional and social media recruitment methods based on study goals and population.
McCullagh, Marjorie C.; Sanon, Marie-Anne; Cohen, Michael A
Challenges associated with recruiting and retaining community-based populations in research studies have been recognized yet remain of major concern for researchers. There is a need for exchange of recruitment and retention techniques that inform recruitment and retention strategies. Here, the authors discuss a variety of methods that were successful in exceeding target recruitment and retention goals in a randomized clinical trial of hearing protector use among farm operators. Recruitment an...
Noce, Damia; Gögele, Martin; Schwienbacher, Christine; Caprioli, Giulia; De Grandi, Alessandro; Foco, Luisa; Platzgummer, Stefan; Pramstaller, Peter P; Pattaro, Cristian
After the success of genome-wide association studies to uncover complex trait loci, attempts to explain the remaining genetic heritability (h (2)) are mainly focused on unraveling rare variant associations and gene-gene or gene-environment interactions. Little attention is paid to the possibility that h (2) estimates are inflated as a consequence of the epidemiological study design. We studied the time series of 54 biochemical traits in 4373 individuals from the Cooperative Health Research In South Tyrol (CHRIS) study, a pedigree-based study enrolling ten participants/day over several years, with close relatives preferentially invited within the same day. We observed distributional changes of measured traits over time. We hypothesized that the combination of such changes with the pedigree structure might generate a shared-environment component with consequent h (2) inflation. We performed variance components (VC) h (2) estimation for all traits after accounting for the enrollment period in a linear mixed model (two-stage approach). Accounting for the enrollment period caused a median h (2) reduction of 4%. For 9 traits, the reduction was of >20%. Results were confirmed by a Bayesian Markov chain Monte Carlo analysis with all VCs included at the same time (one-stage approach). The electrolytes were the traits most affected by the enrollment period. The h (2) inflation was independent of the h (2) magnitude, laboratory protocol changes, and length of the enrollment period. The enrollment process may induce shared-environment effects even under very stringent and standardized operating procedures, causing h (2) inflation. Including the day of participation as a random effect is a sensitive way to avoid overestimation.
Whitebird, Robin R.; Kreitzer, Mary Jo; Lewis, Beth A.; Hanson, Leah R.; Crain, A. Lauren; Enstad, Chris J.; Mehta, Adele
Caregivers for a family member with dementia experience chronic long-term stress that may benefit from new complementary therapies such as mindfulness-based stress reduction. Little is known however, about the challenges of recruiting and retaining family caregivers to research on mind-body based complementary therapies. Our pilot study is the first of its kind to successfully recruit caregivers for a family member with dementia to a randomized controlled pilot study of mindfulness-based stress reduction. The study used an array of recruitment strategies and techniques that were tailored to fit the unique features of our recruitment sources and employed retention strategies that placed high value on establishing early and ongoing communication with potential participants. Innovative recruitment methods including conducting outreach to health plan members and generating press coverage were combined with standard methods of community outreach and paid advertising. We were successful in exceeding our recruitment goal and retained 92% of the study participants at post-intervention (2 months) and 90% at 6 months. Recruitment and retention for family caregiver interventions employing mind-body based complementary therapies can be successful despite many challenges. Barriers include cultural perceptions about the use and benefit of complementary therapies, cultural differences with how the role of family caregiver is perceived, the use of group-based designs requiring significant time commitment by participants, and travel and respite care needs for busy family caregivers. PMID:21601010
Full Text Available Abstract Objectives To pilot using a panel of members of the public to provide preference data via the Internet Methods A stratified random sample of members of the general public was recruited and familiarised with the standard gamble procedure using an Internet based tool. Health states were perdiodically presented in "sets" corresponding to different conditions, during the study. The following were described: Recruitment (proportion of people approached who were trained; Participation (a the proportion of people trained who provided any preferences and (b the proportion of panel members who contributed to each "set" of values; and Compliance (the proportion, per participant, of preference tasks which were completed. The influence of covariates on these outcomes was investigated using univariate and multivariate analyses. Results A panel of 112 people was recruited. 23% of those approached (n = 5,320 responded to the invitation, and 24% of respondents (n = 1,215 were willing to participate (net = 5.5%. However, eventual recruitment rates, following training, were low (2.1% of those approached. Recruitment from areas of high socioeconomic deprivation and among ethnic minority communities was low. Eighteen sets of health state descriptions were considered over 14 months. 74% of panel members carried out at least one valuation task. People from areas of higher socioeconomic deprivation and unmarried people were less likely to participate. An average of 41% of panel members expressed preferences on each set of descriptions. Compliance ranged from 3% to 100%. Conclusion It is feasible to establish a panel of members of the general public to express preferences on a wide range of health state descriptions using the Internet, although differential recruitment and attrition are important challenges. Particular attention to recruitment and retention in areas of high socioeconomic deprivation and among ethnic minority communities is necessary
Heijmans, Naomi; van Lieshout, Jan; Wensing, Michel
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 using telephone interviews and postal questionnaires as modes of interest. Aiming to explore effects of choice of participation, two randomized controlled trials were performed comparing participation rates of patients provided with and without choice of participation mode, using interviews and questionnaires as participation modes. Two trials were embedded in a larger study on cardiovascular risk management in primary care. Patients with a chronic cardiovascular condition recruited for the larger study were invited to participate in an additional survey on social networks, using invitations with and without choice of participation mode. Primary outcome was participation rate. Other outcomes of interest were participation rate conditional on willingness to participate, and initial willingness to participate. In trial 1 we compared outcomes after choice of participation mode (interview or questionnaire) with invitations for participation in a telephone interview. In Trial 2 results for choice of participation mode were compared with postal questionnaires. In Trial 1 no differences were found in participation rates (65% vs 66%, p = 0.853) although conditional participation rate was highest for interviews (90% vs 72%, p choice of participation mode was provided (90% versus 73%, p choice of participation mode was provided (59% vs 46%, p choice of participation mode had benefit on participation rates compared to invitations to participate in questionnaires, but not when compared to invitations to participate in telephone interviews. Current Controlled Trials ISRCTN89237105 .
Tolonen, Hanna; Ahonen, Sanna; Jentoft, Susie; Kuulasmaa, Kari; Heldal, Johan
In the 1980s, participation rates in health interview and health examination surveys were around 80% while now they are around 50-60%. There is also evidence that non-participation is selective. Low participation rates and selective non-participation may cause bias to our survey results based on participants alone. We aim to increase knowledge on cultural differences in acceptance and feasibility of different recruitment methods. The European Health Examination Survey Pilot Project, conducted in 2009-2012, included pilot surveys in 12 countries among people aged 25-64 years. Information about recruitment methods and participation rates in these surveys was collected. Participation rates ranged from 16% to 57% for men and from 31% to 74% for women, where in most surveys women had higher participation rates than men. A variety of recruitment and promotion methods were used to obtain as high participation rates as possible. Combinations of phone calls, invitation letter and home visits were used to recruit invitees. Obtaining valid phone numbers for survey invitees was difficult in several countries. Incentives, websites and promotion in local media were used to promote the surveys. The European Health Examination Survey Pilot surveys showed that obtaining a participation rate above 50% for a representative population sample is possible but it requires hard work and a well-planned recruitment strategy. Recruitment methods used in one country may not be possible to use in another country due to cultural norms and national regulations. © 2015 the Nordic Societies of Public Health.
Johnson, Anna M; Jones, Sara B; Duncan, Pamela W; Bushnell, Cheryl D; Coleman, Sylvia W; Mettam, Laurie H; Kucharska-Newton, Anna M; Sissine, Mysha E; Rosamond, Wayne D
Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board
Beaton, Sarah J; Sperl-Hillen, JoAnn M; Worley, Ann Von; Fernandes, Omar D; Baumer, Dorothy; Hanson, Ann M; Parker, Emily D; Busch, Maureen E; Davis, Herbert T; Spain, C Victor
Recruitment methods heavily impact budget and outcomes in clinical trials. We conducted a post-hoc examination of the efficiency and cost of three different recruitment methods used in Journey for Control of Diabetes: the IDEA Study, a randomized controlled trial evaluating outcomes of group and individual diabetes education in New Mexico and Minnesota. Electronic databases were used to identify health plan members with diabetes and then one of the following three methods was used to recruit study participants: 1. Minnesota Method 1--Mail only (first half of recruitment period). Mailed invitations with return-response forms. 2. Minnesota Method 2--Mail and selective phone calls (second half of recruitment period). Mailed invitations with return-response forms and subsequent phone calls to nonresponders. 3. New Mexico Method 3--Mail and non-selective phone calls (full recruitment period): Mailed invitations with subsequent phone calls to all. The combined methods succeeded in meeting the recruitment goal of 623 subjects. There were 147 subjects recruited using Minnesota's Method 1, 190 using Minnesota's Method 2, and 286 using New Mexico's Method 3. Efficiency rates (percentage of invited patients who enrolled) were 4.2% for Method 1, 8.4% for Method 2, and 7.9% for Method 3. Calculated costs per enrolled subject were $71.58 (Method 1), $85.47 (Method 2), and $92.09 (Method 3). A mail-only method to assess study interest was relatively inexpensive but not efficient enough to sustain recruitment targets. Phone call follow-up after mailed invitations added to recruitment efficiency. Use of return-response forms with selective phone follow-up to non-responders was cost effective. Copyright © 2010 Elsevier Inc. All rights reserved.
March, Joan Carles; Oviedo-Joekes, Eugenia; Romero, Manuel; Gómez, Miguel; Rodríguez, Salvador; León, M Isabel; Rodríguez, Cristina
In this field note we describe the steps followed in the process of recruiting participants for the experimental drug prescription program in Andalusia (PEPSA). This trial is a comparative, randomized, open study of the difference between intravenous heroin treatment and oral methadone for socially excluded, opiate-dependent patients, in whom other available treatments have been unsuccessful. Because this is a hidden and hard-to-reach population, a specific approach was planned to put as many patients as possible in touch with the program. A previous study of the target population's distribution in the City of Granada was performed and the city was divided into three areas. Potential participants were interviewed in squares, soup kitchens and methadone dispensaries by outreach workers and peers, who suggested they make an appointment with a PEPSA physician. Peer-driven intervention was a crucial instrument in this recruitment procedure, allowing greater access to the target population. Furthermore, this approach allowed contact with drug users who do not attend health and social services. The work of the outreach team involved educating these users in harm reduction and offering them health and social alternatives beyond the clinical trial.
Kooistra, Bauke W; Dijkman, Bernadette G; Guyatt, Gordon H; Sprague, Sheila; Tornetta, Paul; Bhandari, Mohit
To compare the accuracy of estimates of potential recruitment from a prospective 8-week screening study compared with a retrospective chart review across sites participating in two fracture management trials. During the planning phase of two large, multicenter, randomized controlled fracture management trials, 74 clinical sites provided estimates of the annual recruitment rate both retrospectively (based on chart reviews) and prospectively. The prospective estimate was generated by screening, for 8 weeks, all incoming patients for eligibility in the concerning trial, without actually enrolling any patient. We compared these prospective and retrospective estimates with one another (for 74 sites in the two trials) and with actual 1-year recruitment rates in the definitive trial (for nine sites in one trial). There was a median difference of four patients (interquartile range: -14 to 18 patients; P=0.89) between a center's prospective estimate and its retrospective estimate. Both predictions were overestimations of recruitment in the definitive trial; only 31% (95% confidence interval [CI]: 28, 35) of retrospectively estimated patients, and 31% (95% CI: 27, 35) of prospectively estimated patients were recruited in the definitive trials. Compared with relatively simple chart reviews, prospectively screening for eligible patients at clinical sites, which is associated with substantial costs, did not result in more accurate predictions of accrual in large, multicenter, randomized controlled trials. Copyright © 2011 Elsevier Inc. All rights reserved.
Adam, Laura M; Manca, Donna P
Background Recruitment is often a difficult and costly part of any human research study. Social media and other emerging means of mass communication hold promise as means to complement traditional strategies used for recruiting participants because they can reach a large number of people in a short amount of time. With the ability to target a specified audience, paid Facebook advertisements have potential to reach future research participants of a specific demographic. This paper describes the experiences of a randomized controlled trial in Edmonton, Alberta, attempting to recruit healthy pregnant women between 8 and 20 weeks’ gestation for participation in a prenatal study. Various traditional recruitment approaches, in addition to paid Facebook advertisements were trialed. Objective To evaluate the effectiveness of paid advertisements on Facebook as a platform for recruiting pregnant women to a randomized controlled trial in comparison with traditional recruitment approaches. Methods Recruitment using traditional approaches occurred for 7 months, whereas Facebook advertisements ran for a total of 26 days. Interested women were prompted to contact the study staff for a screening call to determine study eligibility. Costs associated with each recruitment approach were recorded and used to calculate the cost to recruit eligible participants. Performance of Facebook advertisements was monitored using Facebook Ads Manager. Results Of the 115 women included, 39.1% (n=45) of the women who contacted study staff heard about the study through Facebook, whereas 60.9% (n=70) of them heard about it through traditional recruitment approaches. During the 215 days (~7 months) that the traditional approaches were used, the average rate of interest was 0.3 (0.2) women/day, whereas the 26 days of Facebook advertisements resulted in an average rate of interest of 2.8 (1.7) women/day. Facebook advertisements cost Can $506.91 with a cost per eligible participant of Cad $20.28. In
Adam, Laura M; Manca, Donna P; Bell, Rhonda C
Recruitment is often a difficult and costly part of any human research study. Social media and other emerging means of mass communication hold promise as means to complement traditional strategies used for recruiting participants because they can reach a large number of people in a short amount of time. With the ability to target a specified audience, paid Facebook advertisements have potential to reach future research participants of a specific demographic. This paper describes the experiences of a randomized controlled trial in Edmonton, Alberta, attempting to recruit healthy pregnant women between 8 and 20 weeks' gestation for participation in a prenatal study. Various traditional recruitment approaches, in addition to paid Facebook advertisements were trialed. To evaluate the effectiveness of paid advertisements on Facebook as a platform for recruiting pregnant women to a randomized controlled trial in comparison with traditional recruitment approaches. Recruitment using traditional approaches occurred for 7 months, whereas Facebook advertisements ran for a total of 26 days. Interested women were prompted to contact the study staff for a screening call to determine study eligibility. Costs associated with each recruitment approach were recorded and used to calculate the cost to recruit eligible participants. Performance of Facebook advertisements was monitored using Facebook Ads Manager. Of the 115 women included, 39.1% (n=45) of the women who contacted study staff heard about the study through Facebook, whereas 60.9% (n=70) of them heard about it through traditional recruitment approaches. During the 215 days (~7 months) that the traditional approaches were used, the average rate of interest was 0.3 (0.2) women/day, whereas the 26 days of Facebook advertisements resulted in an average rate of interest of 2.8 (1.7) women/day. Facebook advertisements cost Can $506.91 with a cost per eligible participant of Cad $20.28. In comparison, the traditional approaches
McCullagh, Marjorie C; Sanon, Marie-Anne; Cohen, Michael A
Challenges associated with recruiting and retaining community-based populations in research studies have been recognized yet remain of major concern for researchers. There is a need for exchange of recruitment and retention techniques that inform recruitment and retention strategies. Here, the authors discuss a variety of methods that were successful in exceeding target recruitment and retention goals in a randomized clinical trial of hearing protector use among farm operators. Recruitment and retention strategies were 1) based on a philosophy of mutually beneficial engagement in the research process, 2) culturally appropriate, 3) tailored to the unique needs of partnering agencies, and 4) developed and refined in a cyclical and iterative process. Sponsoring organizations are interested in cost-effective recruitment and retention strategies, particularly relating to culturally and ethnically diverse groups. These approaches may result in enhanced subject recruitment and retention, concomitant containment of study costs, and timely accomplishment of study aims. Copyright © 2014 Elsevier Inc. All rights reserved.
Cooke, Rachel; Jones, Andy
To undertake a systematic review of the effectiveness of recruitment mechanisms for engaging and retaining target participants in sports interventions to promote physical activity behaviour change in adults. A narrative systematic review of published studies providing details of the effectiveness of recruitment techniques used in interventions aimed at increasing physical activity via sport in adults. Searches were conducted using five electronic databases, clinical trial registers, grey literature and snowballing from reference lists. All papers published in the English language were considered. The search was completed in November 2015. All articles providing information on the recruitment of adults into interventions involving sport and reporting physical activity or participation outcomes were included. Twenty-three studies met the inclusion criteria. The quality of recruitment reporting across included studies was generally classified as poor, lacking detailed descriptions of recruitment processes and providing insufficient reporting of recruitment outcomes. There was a distinct recruitment bias for more affluent, white, middle-aged women. Active-only recruitment techniques appeared to achieve a participant sample with more representative demographic characteristics than passive approaches. Due to inadequate reporting and evaluation, the mechanisms for achieving effective recruitment and engagement in sport, particularly in hard-to-reach groups, are still unclear. Independent of recruitment mode, creating an intervention and context that reflect the interests and motivations of the target audience presents a promising area. There is an urgent need for more robust evaluation design and reporting of sports interventions.
Batterham, Philip J
Postal and telephone survey research is threatened by declining response rates and high cost. Online recruitment is becoming more popular, although there is little empirical evidence about its cost-effectiveness or the representativeness of online samples. There is also limited research on optimal strategies for developing advertising content for online recruitment. The present study aimed to assess these aspects of online recruitment. Two mental health surveys used advertisements within a social network website (Facebook) to recruit adult Australian participants. The initial survey used advertisements linking directly to an external survey website, and recruited 1283 participants at $9.82 per completed survey. A subsequent survey used advertisements linking to a Facebook page that featured links to the external survey, recruiting 610 participants at $1.51 per completion. Both surveys were more cost-effective than similar postal surveys conducted previously, which averaged $19.10 per completion. Online and postal surveys both had somewhat unrepresentative samples. However, online surveys tended to be more successful in recruiting hard-to-reach populations. Advertising using "problem" terminology was more effective than "positive" terminology, while there was no significant effect of altruistic versus self-gain terminology. Online recruitment is efficient, flexible and cost-effective, suggesting that online recruitment has considerable potential for specific research designs. Copyright © 2014 John Wiley & Sons, Ltd.
Taylor-Piliae, Ruth E; Boros, Daniella; Coull, Bruce M
Relatively few exercise randomized clinical trials (RCTs) among stroke survivors have reported the effectiveness of recruitment and retention strategies, despite its central importance to study integrity. Our objective is to examine recruitment and retention strategies used among a group of older community-dwelling stroke survivors for an exercise RCT. Recruitment strategies were multidimensional using both paid (ie, newspaper, radio and, television) and unpaid advertisements (ie, staff visits, flyers, and brochures placed at outpatient rehabilitation centers, physician offices, and community facilities working with older adults; free media coverage of the study, presentations at stroke support groups, relatives/friends, and study Web site) to obtain referrals. Retention strategies centered on excellent communication, the study participants' needs, and having dedicated study staff. Attrition rates and adherence to the intervention were used to examine the effectiveness of these retention strategies. A total of 393 referrals were received, 233 persons were screened, and 145 stroke survivors enrolled in the study. During 3 years of study recruitment, we achieved 97% of our enrollment target. We enrolled 62% of those screened. Study enrollment from paid advertising was 21.4% (n = 31), whereas unpaid advertisements resulted in 78.6% (n = 114) of our participants. Attrition was 10% (n = 14 dropouts), and adherence to the intervention was 85%. Recruitment and retention of participants in an exercise RCT are time and labor intensive. Multiple recruitment and retention strategies are required to ensure an adequate sample of community-dwelling stroke survivors. Many of these strategies are also relevant for exercise RCTs among adults with other chronic illnesses. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.
Keightley, A; Clarkson, J; Maguire, A; Speed, C; Innes, N
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.
Robert Thomson; Naoya Ito
Facebook’s global reach suggests good potential for recruiting research participants and collecting objective behavioral data for cross-cultural research. Previous literature suggests the usefulness of Facebook advertisements to recruit participants in single-country studies. However, Facebook advert use in multi-country studies has not yet been reported. Nor are there any reports about soliciting Facebook user data (via Facebook applications) using Facebook advertisements. This paper contrib...
Eldridge, Sandra; Kerry, Sally; Torgerson, D.J.
(Summary Points) . Poor design of cluster trials risks bias in selection of participants. . Ideally participants should be identified before the cluster is randomised. . When this is not possible recruitment should be by someone masked to the cluster allocation. . Statistical solutions to selection bias are less satisfactory than design solutions. . Cluster trials need to report cluster sizes to enable the readers to ascertain any differences in recruitment between treatment groups.
Child, Rebekah Jay Howerton; Mentes, Janet C; Pavlish, Carol; Phillips, Linda R
To examine the use of social networking sites in recruiting research participants. Workplace violence is an important issue for staff and patients. One workplace that reports the highest levels of violence is the emergency department. The ability to research issues such as workplace violence in real time is important in addressing them expeditiously, and social media can be used to advertise and recruit research subjects, implement studies and disseminate information. The experience of recruiting subjects through social networks, specifically Facebook, and the use of participant information clips (PICs) for advertising. A brief discussion of the history of advertising and communication using the internet is presented to provide an understanding of the trajectory of social media and implications for recruitment in general. The paper then focuses on the lead author's experience of recruiting subjects using Facebook, including its limitations and advantages, and her experience of using participant information clips. The low cost of advertising and recruiting participants this way, as well as the convenience provided to participants, resulted in almost half the study's total participants being obtained within 72 hours. Using Facebook to target a younger age range of nurses to participate in a study was successful and yielded a large number of completed responses in a short time period at little cost to the researcher. Recording the PIC was cheap, and posting it and a link to the site on pre-existing group pages was free, providing valuable viral marketing and snowball recruiting. Future researchers should not overlook using social network sites for recruitment if the demographics of the desired study population and subject matter permit it.
Oesterle, Sabrina; Epstein, Marina; Haggerty, Kevin P; Moreno, Megan A
Despite strong evidence that family programs are effective in preventing adolescent substance use, recruiting parents to participate in such programs remains a persistent challenge. This study explored the feasibility of using Facebook to recruit parents of middle school students to a self-directed family program to prevent adolescent drug use. The study used paid Facebook ads aiming to recruit 100 parents in Washington and Colorado using marijuana- or parenting-focused messages. All ad-recruited parents were also invited to refer others in order to compare Facebook recruitment to web-based respondent-driven sampling. Despite offering a $15 incentive for each successfully referred participant, the majority of the screened (70.4%) and eligible (65.1%) parents were recruited through Facebook ads. Yet, eligibility and consent rates were significantly higher among referred (76.6 and 57.3%, respectively) than Facebook-recruited parents (60.0 and 36.6%, respectively). Click-through rates on Facebook were higher for marijuana-focused than parenting-focused ads (0.72 and 0.65%, respectively). The final sample (54% Facebook-recruited) consisted of 103 demographically homogeneous parents (female, educated, non-Hispanic White, and mostly from Washington). Although Facebook was an effective and efficient method to recruit parents to a study with equal to better cost-effectiveness than traditional recruitment strategies, the promise of social media to reach a diverse population was not realized. Additional approaches to Facebook recruitment are needed to reach diverse samples in real-world settings and increase public health impact of family programs.
Embi, Peter J; Jain, Anil; Clark, Jeffrey; Bizjack, Susan; Hornung, Richard; Harris, C Martin
Failure to recruit a sufficient number of eligible subjects in a timely manner represents a major impediment to the success of clinical trials. Physician participation is vital to trial recruitment but is often limited. After 12 months of traditional recruitment to a clinical trial, we activated our electronic health record (EHR)-based clinical trial alert (CTA) system in selected outpatient clinics of a large, US academic health care system. When a patient's EHR data met selected trial criteria during the subsequent 4-month intervention period, the CTA prompted physician consideration of the patient's eligibility and facilitated secure messaging to the trial's coordinator. Subjects were the 114 physicians practicing at selected EHR-equipped clinics throughout our study. We compared differences in the number of physicians participating in recruitment and their recruitment rates before and after CTA activation. The CTA intervention was associated with significant increases in the number of physicians generating referrals (5 before and 42 after; P based CTA led to significant increases in physicians' participation in and recruitment rates to an ongoing clinical trial. Given the trend toward the EHR implementation in health care centers engaged in clinical research, this approach may represent a much-needed solution to the common problem of inadequate trial recruitment.
Full Text Available Abstract Background The feasibility of randomized trials often depends on successful patient recruitment. Although numerous recruitment barriers have been identified it is unclear which of them complicate recruitment most. Also, most surveys have focused on the patients' perspective of recruitment barriers whereas the perspective of recruiting physicians has received less attention. Therefore, our aim was to conduct a postal survey among recruiting physicians of a multi-center trial to weigh barriers according to their impact on recruitment. Methods We identified any potential recruitment barriers from the literature and from our own experience with a multi-center trial of respiratory rehabilitation in patients with chronic obstructive pulmonary disease. We developed and pilot-tested a self-administered questionnaire where recruiting physicians were asked to express their agreement with statements about recruitment barriers on a Likert-type scale from 1 (full agreement with statement = very substantial recruitment barrier to 7 (no agreement with statement = no recruitment barrier. Results 38 of 55 recruiting physicians returned questionnaires (69% response rate, of which 35 could be analyzed (64% useable response rate. Recruiting physicians reported that "time constraints" (median agreement of 3, interquartile range 2–5 had the most negative impact on recruitment followed by "difficulties including identified eligible patients" (median agreement of 5, IQR 3–6. Other barriers such as "trial design barriers", "lack of access to treatment", "individual barriers of recruiting physicians" or "insufficient training of recruiting physicians" were perceived to have little or no impact on patient recruitment. Conclusion Physicians perceived time constraints as the most relevant recruitment barrier in a randomized trial. To overcome recruitment barriers interventions, that are affordable for both industry- and investigator-driven trials, need to be
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
Burton-Chase, Allison M; Parker, Wendy M; Hennig, Kelsey; Sisson, Faith; Bruzzone, Linda L
Social media is increasingly being used as a means of recruiting participants, particularly for investigators whose areas of interest involve rare conditions or hard-to-reach populations. However, much of the literature to date has focused on paid advertisement recruitment. We used Lynch syndrome (LS), a rare hereditary cancer syndrome, as a model to demonstrate the successful partnership between researchers and a Web-based patient education and advocacy organization to facilitate participant recruitment. Recruitment was undertaken in partnership with Lynch Syndrome International (LSI), an advocacy organization with a strong social media presence. After LSI published our study information, participants followed up via email or phone call. Following prescreening and consent, interested and eligible participants were then sent a secure survey link. Within 36 hours of a single Facebook post by the site administrators for LSI, over 150 individuals responded via phone or email. Sixty-five individuals were sent the survey link and 57 individuals completed the survey (88% response rate). Of note, these 57 individuals were geographically diverse within the Unites States, representing LS patients from 26 different states. This approach has several advantages, including recruitment through a trusted source outside of a clinical setting, higher response rates, and cost-effectiveness with a small research team in a relatively short amount of time. Overall, social media recruitment with a trusted online partner can be highly effective in hard-to-reach clinical populations, such as patients with LS. However, this approach requires additional effort for eligibility screening.
García, Alexandra A; Zuñiga, Julie A; Lagon, Czarina
People from non-White racial groups and other underserved populations, including Latinos, are frequently reluctant to participate in research. Yet their participation into research is foundational to producing information that researchers and health care providers need to address health disparities. The purpose of this article is to describe challenges we have encountered along with culturally relevant strategies we used in five research studies to recruit Mexican American participants from community settings, some of whom were also of low socioeconomic status. We found that the most effective recruitment strategies reflect the common cultural values of personalismo, simpátia, confianza, respeto, and familismo.
Kaba, Alyshah; Beran, Tanya
The success of research in interprofessional education is largely due to the participation of students. Their recruitment is, however, perhaps the most challenging part of any study, and, yet, is a key determinant of the results. The aim of this article is to provide a "how to guide" for medical education researchers to facilitate the recruitment of students across health professions. The 12 tips are (1) establish clear expectations with your research team from the start; (2) do your homework: invest time and energy in pre-recruitment preparation; (3) develop a plan: be realistic about your resources; (4) create a "Buzz" about your interprofessional research; (5) prepare multiple communication methods - can't just rely on one! (6) engage volunteers across professions to participate; (7) address the participant's willingness to take part in the research; (8) demonstrate good interpersonal skills; (9) be diligent in tracking participants; (10) show appreciation and share results; (11) consider participant incentives: are they really important? (12) maintain tenacity - no one said interprofessional recruitment was easy! Interprofessional studies offer numerous logistical, administrative and scheduling challenges; the 12 tips are provided to help medical education researchers develop and manage the successful recruitment of students across the health professions.
Whitaker, Christopher; Stevelink, Sharon; Fear, Nicola
Social media is a popular online tool that allows users to communicate and exchange information. It allows digital content such as pictures, videos and websites to be shared, discussed, republished and endorsed by its users, their friends and businesses. Adverts can be posted and promoted to specific target audiences by demographics such as region, age or gender. Recruiting for health research is complex with strict requirement criteria imposed on the participants. Traditional research recruitment relies on flyers, newspaper adverts, radio and television broadcasts, letters, emails, website listings, and word of mouth. These methods are potentially poor at recruiting hard to reach demographics, can be slow and expensive. Recruitment via social media, in particular Facebook, may be faster and cheaper. The aim of this study was to systematically review the literature regarding the current use and success of Facebook to recruit participants for health research purposes. A literature review was completed in March 2017 in the English language using MEDLINE, EMBASE, Web of Science, PubMed, PsycInfo, Google Scholar, and a hand search of article references. Papers from the past 12 years were included and number of participants, recruitment period, number of impressions, cost per click or participant, and conversion rate extracted. A total of 35 studies were identified from the United States (n=22), Australia (n=9), Canada (n=2), Japan (n=1), and Germany (n=1) and appraised using the Critical Appraisal Skills Programme (CASP) checklist. All focused on the feasibility of recruitment via Facebook, with some (n=10) also testing interventions, such as smoking cessation and depression reduction. Most recruited young age groups (16-24 years), with the remaining targeting specific demographics, for example, military veterans. Information from the 35 studies was analyzed with median values being 264 recruited participants, a 3-month recruitment period, 3.3 million impressions, cost
Michie, Marsha; Cadigan, R Jean; Henderson, Gail; Beskow, Laura M
Genotype-driven research recruitment complicates traditional study roles and may leave those recruited worried about unwelcome surprises from their DNA. This study investigated the ways that individuals experience genotype-driven recruitment, and conceptualize their roles as research participants. Individual interviews were conducted with the participants of a genotype-driven study on cystic fibrosis. The eligibility criteria included the presence of one of two genetic variants. We interviewed 24 of these participants: 9 had cystic fibrosis and 15 had been selected from a biobank as "healthy volunteers." Participants with cystic fibrosis expressed no concerns about the eligibility criteria and saw themselves as part of a close-knit research community. However, biobank participants were unsure about why they had been selected and how they should think about themselves relative to the study. They sometimes reacted with anxiety to genetic information that they perceived to connect them with cystic fibrosis. Being recruited for a study on the basis of one's genotype may raise uncertainties about the meaning and implications of the genotypic information. People without the disease under study may require especially clear and detailed explanations of what researchers already know about their genetic makeup, in terms of future risk for themselves or their children.
Geue, Kristina; Richter, Robert; Buttstaedt, Marianne; Braehler, Elmar; Boehler, Ursula; Singer, Susanne
Over the last years, there has been increasing focus on the effect of art therapy for oncological patients. The small sample sizes of these studies show that recruiting participants is difficult and has been poorly investigated. It is also apparent that women participate in art therapy more often than men. The question remains why this difference exists and if participating men benefit from these courses more, less or in a different way than women do. We developed and tested an outpatient art intervention for cancer patients, whereby different recruitment strategies were documented. Participants were questioned about their mental health (HADS), coping strategies (FKV), and quality of life (EORTC QLQ-C30) at the beginning and end of the intervention. The recruitment strategies included personal letters, referrals from the "Information Center For Cancer Patients", press releases and leaflets/posters distributed to hospitals and medical practices. About half of the participants (N=35), especially the male ones, took part in response to receiving a personal letter. All in all, 14 men and 60 women took part in the intervention whereby all 18 drop-outs were female. There were no significant gender differences regarding distress and quality of life before and after the intervention (men=14; women=41). A variety of approaches and intense public relations are necessary to recruit patients for art therapy. Describing recruitment strategies more in detail is suggested for upcoming art therapy studies. First gender specific differences were found in recruitment and usage. Exploring further questions in this area referring to quality of life and distress larger and uniformly distributed samples are desirable.
Waerden, J.E.B. van der; Hoefnagels, C.C.J.; Jansen, M.W.J.; Hosman, C.M.H.
Background Recruitment, willingness to participate, and retention in interventions are indispensable for successful prevention. This study investigated the effectiveness of different strategies for recruiting and retaining low-SES women in depression prevention, and explored which sociodemographic
Rupert, Douglas J; Poehlman, Jon A; Hayes, Jennifer J; Ray, Sarah E; Moultrie, Rebecca R
Virtual focus groups-such as online chat and video groups-are increasingly promoted as qualitative research tools. Theoretically, virtual groups offer several advantages, including lower cost, faster recruitment, greater geographic diversity, enrollment of hard-to-reach populations, and reduced participant burden. However, no study has compared virtual and in-person focus groups on these metrics. To rigorously compare virtual and in-person focus groups on cost, recruitment, and participant logistics. We examined 3 focus group modes and instituted experimental controls to ensure a fair comparison. We conducted 6 1-hour focus groups in August 2014 using in-person (n=2), live chat (n=2), and video (n=2) modes with individuals who had type 2 diabetes (n=48 enrolled, n=39 completed). In planning groups, we solicited bids from 6 virtual platform vendors and 4 recruitment firms. We then selected 1 platform or facility per mode and a single recruitment firm across all modes. To minimize bias, the recruitment firm employed different recruiters by mode who were blinded to recruitment efforts for other modes. We tracked enrollment during a 2-week period. A single moderator conducted all groups using the same guide, which addressed the use of technology to communicate with health care providers. We conducted the groups at the same times of day on Monday to Wednesday during a single week. At the end of each group, participants completed a short survey. Virtual focus groups offered minimal cost savings compared with in-person groups (US $2000 per chat group vs US $2576 per in-person group vs US $2,750 per video group). Although virtual groups did not incur travel costs, they often had higher management fees and miscellaneous expenses (eg, participant webcams). Recruitment timing did not differ by mode, but show rates were higher for in-person groups (94% [15/16] in-person vs 81% [13/16] video vs 69% [11/16] chat). Virtual group participants were more geographically diverse (but
Johnson, Kimberly J; Mueller, Nancy L; Williams, Katherine; Gutmann, David H
Internet communication advances provide new opportunities to assemble individuals with rare diseases to online patient registries from wide geographic areas for research. However, there is little published information on the efficacy of different recruitment methods. Here we describe recruitment patterns and the characteristics of individuals with the self-identified autosomal dominant genetic disorder neurofibromatosis type 1 (NF1) who participated in an online patient registry during the 1-year period from 1/1/2012 to 12/31/2012. We employed four main mechanisms to alert potential participants to the registry: (1) Facebook and Google advertising, (2) government and academic websites, (3) patient advocacy groups, and (4) healthcare providers. Participants reported how they first heard about the registry through an online questionnaire. During the 1-year period, 880 individuals participated in the registry from all 50 U.S. States, the District of Columbia, Puerto Rico, and 39 countries. Facebook and Google were reported as referral sources by the highest number of participants (n=550, 72% Facebook), followed by healthcare providers (n=74), and government and academic websites (n=71). The mean participant age was 29±18 years and most participants reported White race (73%) and female sex (62%) irrespective of reported referral source. Internet advertising, especially through Facebook, resulted in efficient enrollment of large numbers of individuals with NF1. Our study demonstrates the potential utility of this approach to assemble individuals with a rare disease from across the world for research studies. © 2014 Wiley Periodicals, Inc.
Barnett, Josephine; Aguilar, Stephanie; Brittner, Mindy; Bonuck, Karen
Developing effective recruitment and retention strategies in populations with traditionally high attrition rates is critical to the success of Randomized Controlled Trials (RCTs). Data on successful participation of women from low-income, minority populations in RCTs of behavioral interventions are limited. This is problematic given the multiplicity of Healthy People 2020 goals that target health disparities in these populations. This paper reports successful recruitment and retention methods from two separately funded NIH clinical trials of primary care-based prenatal interventions to increase breastfeeding among ethnically diverse, low-income women in urban medical centers in the Bronx, NY. It also presents the required staff effort necessary to conduct such a successful RCT, in terms of full-time equivalents (FTEs). Results include timely recruitment of 941 participants over 29 months, with 98.1% completing >¯¯1 follow-up interview. A recruitment and retention plan that maximized study staff access and availability to the participant, as well as strong study staff rapport with participants, addressed previously reported barriers in this population, optimizing follow-up rates. A qualitative assessment of the participants' study experience suggesting that high retention was due to strong rapport with participants, short interviews requiring little time commitment, and participants' perception of the study as informative, provides further evidence of our approach's effectiveness. Logistical protocol procedures and staff management strategies relating to successful recruitment/retention are provided to propose a practical, cost-effective and translational recruitment-retention plan for other researchers to adopt. Copyright © 2012 Elsevier Inc. All rights reserved.
Basaluzzo, Gabriel; Miravete, Eugenio J.
We present a flexible model of monopoly nonlinear pricing with endogenous participation decisions of heterogeneous consumers. We make use of the moments that define the few self-selecting tariff options that are commonly used to implement the optimal nonlinear tariff to estimate how demand and cost variables affect the pricing strategies offered by incumbent monopolists in several early U.S. local cellular telephone markets through the different elements of the theoretical model: marginal cos...
Training health professionals to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT randomized controlled trial recruitment training intervention.
Mills, Nicola; Gaunt, Daisy; Blazeby, Jane M; Elliott, Daisy; Husbands, Samantha; Holding, Peter; Rooshenas, Leila; Jepson, Marcus; Young, Bridget; Bower, Peter; Tudur Smith, Catrin; Gamble, Carrol; Donovan, Jenny L
The objective of this study was to describe and evaluate a training intervention for recruiting patients to randomized controlled trials (RCTs), particularly for those anticipated to be difficult for recruitment. One of three training workshops was offered to surgeons and one to research nurses. Self-confidence in recruitment was measured through questionnaires before and up to 3 months after training; perceived impact of training on practice was assessed after. Data were analyzed using two-sample t-tests and supplemented with findings from the content analysis of free-text comments. Sixty-seven surgeons and 32 nurses attended. Self-confidence scores for all 10 questions increased after training [range of mean scores before 5.1-6.9 and after 6.9-8.2 (scale 0-10, all 95% confidence intervals are above 0 and all P-values recruitment following training was high-surgeons' mean score 8.8 [standard deviation (SD), 1.2] and nurses' 8.4 (SD, 1.3) (scale 0-10); 50% (19/38) of surgeons and 40% (10/25) of nurses reported on a 4-point Likert scale that training had made "a lot" of difference to their RCT discussions. Analysis of free text revealed this was mostly in relation to how to convey equipoise, explain randomization, and manage treatment preferences. Surgeons and research nurses reported increased self-confidence in discussing RCTs with patients, a raised awareness of hidden challenges and a positive impact on recruitment practice following QuinteT RCT Recruitment Training. Training will be made more available and evaluated in relation to recruitment rates and informed consent. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Full Text Available Abstract Background Recruitment and retention are key functions for programs promoting nutrition and other lifestyle behavioral changes in low-income populations. This paper describes strategies for recruitment and retention and presents predictors of early (two-month post intervention and late (eight-month post intervention dropout (non retention and overall retention among young, low-income overweight and obese mothers participating in a community-based randomized pilot trial called Mothers In Motion. Methods Low-income overweight and obese African American and white mothers ages 18 to 34 were recruited from the Special Supplemental Nutrition Program for Women, Infants, and Children in southern Michigan. Participants (n = 129 were randomly assigned to an intervention (n = 64 or control (n = 65 group according to a stratification procedure to equalize representation in two racial groups (African American and white and three body mass index categories (25.0-29.9 kg/m2, 30.0-34.9 kg/m2, and 35.0-39.9 kg/m2. The 10-week theory-based culturally sensitive intervention focused on healthy eating, physical activity, and stress management messages that were delivered via an interactive DVD and reinforced by five peer-support group teleconferences. Forward stepwise multiple logistic regression was performed to examine whether dietary fat, fruit and vegetable intake behaviors, physical activity, perceived stress, positive and negative affect, depression, and race predicted dropout as data were collected two-month and eight-month after the active intervention phase. Results Trained personnel were successful in recruiting subjects. Increased level of depression was a predictor of early dropout (odds ratio = 1.04; 95% CI = 1.00, 1.08; p = 0.03. Greater stress predicted late dropout (odds ratio = 0.20; 95% CI = 0.00, 0.37; p = 0.01. Dietary fat, fruit, and vegetable intake behaviors, physical activity, positive and negative affect, and race were not
Sun, Zhuoyu; Gilbert, Lucy; Ciampi, Antonio; Basso, Olga
Recruiting participants in clinical research is challenging. Certain groups, such as older adults, rural residents, and individuals with lower socio-economic status, are typically underrepresented. Here, we explore perceived motivators and barriers among potential participants in a diagnostic study of ovarian cancer. Women aged 50 and older who answered a mail survey in Montreal, Canada, were asked to assess their eligibility to participate in the ongoing Diagnosing Ovarian cancer Early (DOvE) Study. If 'eligible', they were asked whether they planned to participate in DOvE. Using modified Poisson regression, we examined responders' self-assessment of eligibility, intention to participate, and reasons for why or why not, as a function of socio-demographic and health indicators. Of 826 responders, 33.1% misclassified themselves with respect to eligibility. Among 532 self-assessed eligible women, 56.4% planned to participate in the study. The majority of women not planning to participate preferred to be assessed by their physicians (a reason more commonly reported by those with lower education or income) or believed they were not at risk of ovarian cancer (despite having no fewer risk factors). "Inconvenience" was also a commonly reported reason, especially among rural residents. Women who planned to participate often perceived a benefit (e.g. to rule out ovarian cancer, or to receive a quick check-up). Recruitment, particularly of underrepresented groups, in clinical studies may be enhanced by involving primary care providers, facilitating access to study sites, and providing clear information about the disease under study (including risk factors) and eligibility criteria. Copyright © 2017 Elsevier Inc. All rights reserved.
Gorman, Jessica R; Roberts, Samantha C; Dominick, Sally A; Malcarne, Vanessa L; Dietz, Andrew C; Su, H Irene
Purpose: Cancer survivors in their adolescent and young adult (AYA) years are an understudied population, possibly in part because of the high effort required to recruit them into research studies. The aim of this paper is to describe the specific recruitment strategies used in four studies recruiting AYA-aged female cancer survivors and to identify the highest yielding approaches. We also discuss challenges and recommendations. Methods: We recruited AYA-aged female cancer survivors for two studies conducted locally and two conducted nationally. Recruitment strategies included outreach and referral via: healthcare providers and clinics; social media and the internet; community and word of mouth; and a national fertility information hotline. We calculated the yield of each recruitment approach for the local and national studies by comparing the number that participated to the number of potential participants. Results: We recruited a total of 534 participants into four research studies. Seventy-one percent were diagnosed as young adults and 61% were within 3 years of their cancer diagnosis. The highest-yielding local recruitment strategy was healthcare provider and clinic referral. Nationally, social media and internet outreach yielded the highest rate of participation. Overall, internet-based recruitment resulted in the highest number and yield of participants. Conclusion: Our results suggest that outreach through social media and the internet are effective approaches to recruiting AYA-aged female cancer survivors. Forging collaborative relationships with survivor advocacy groups' members and healthcare providers also proved beneficial.
Scianni, Aline; Teixeira-Salmela, Luci F; Ada, Louise
There is a high demand for stroke rehabilitation in the Brazilian public health system which should make undertaking clinical trials straightforward. The aims of this study were to 1) determine the rate of recruitment of community-dwelling stroke survivors into a randomized trial of the effects of strength training in addition to task-specific gait training, 2) compare the effectiveness of various recruitment strategies on accrual rates, and 3) determine the attendance at training sessions and adherence to the intervention protocol. Participants within six months of a stroke were screened for eligibility and invited to participate. Recruitment strategies were classified as advertisement or referral. The number of people who were screened, eligible and recruited for each strategy was recorded. Attendance at training sessions and adherence to the intervention protocol were recorded. Over the first 14 months, 150 stroke survivors were screened, 10 were recruited, and 35 (23%) were eligible. Twenty-five of these patients (71%) were unable to participate with lack of transport given as the most common reason. The most successful strategy was referral via hospital-based physical therapists (50%). Overall attendance was 72% with lack of transport being the most common reason for non-attendance. Overall adherence to the protocol was 97% with feeling unwell being the most common reason for non-adherence. Recruitment of stroke survivors was inefficient. Lack of transport was the most common barrier to participate in and attend training sessions. Funding for transport is essential to make carrying out trials in Brazil feasible. Trial Registration ACTRN12609000803291.
Kahan, Brennan C
Patient recruitment in clinical trials is often challenging, and as a result, many trials are stopped early due to insufficient recruitment. The re-randomization design allows patients to be re-enrolled and re-randomized for each new treatment episode that they experience. Because it allows multiple enrollments for each patient, this design has been proposed as a way to increase the recruitment rate in clinical trials. However, it is unknown to what extent recruitment could be increased in practice. We modelled the expected recruitment rate for parallel-group and re-randomization trials in different settings based on estimates from real trials and datasets. We considered three clinical areas: in vitro fertilization, severe asthma exacerbations, and acute sickle cell pain crises. We compared the two designs in terms of the expected time to complete recruitment, and the sample size recruited over a fixed recruitment period. Across the different scenarios we considered, we estimated that re-randomization could reduce the expected time to complete recruitment by between 4 and 22 months (relative reductions of 19% and 45%), or increase the sample size recruited over a fixed recruitment period by between 29% and 171%. Re-randomization can increase recruitment most for trials with a short follow-up period, a long trial recruitment duration, and patients with high rates of treatment episodes. Re-randomization has the potential to increase the recruitment rate in certain settings, and could lead to quicker and more efficient trials in these scenarios.
Whittemore, Robin; Jaser, Sarah S; Faulkner, Melissa S; Murphy, Kathryn; Delamater, Alan; Grey, Margaret
The Internet and other eHealth technologies offer a platform for improving the dissemination and accessibility of psychoeducational programs for youth with chronic illness. However, little is known about the recruitment process and yield of diverse samples in Internet research with youth who have a chronic illness. The purpose of this study was to compare the demographic and clinical characteristics of youth with Type 1 diabetes on recruitment, participation, and satisfaction with 2 eHealth psychoeducational programs. Youth with Type 1 diabetes from 4 sites in the United States were invited to participate (N=510) with 320 eligible youth consenting (mean age=12.3, SD 1.1; 55.3% female; 65.2% white; and mean A1C=8.3, SD 1.5). Data for this secondary analysis included demographic information (age, race/ethnicity, and income), depressive symptoms, and recruitment rates, including those who refused at point of contact (22.0%), passive refusers who consented but did not participate (15.3%), and those who enrolled (62.7%). Participation (80% lessons completed) and a satisfaction survey (ie, how helpful, enjoyable) were also analyzed. Chi-square or analysis of variance (ANOVA) analyses were used. There were significant differences in recruitment rates by income and race/ethnicity such that black, Hispanic, or mixed race/ethnicity and low-income youth were more likely to refuse passively compared to white and higher-income youth who were more likely to enroll (Pprogram sessions was high, with 78.1% of youth completing at least 4 of 5 sessions. There were no significant differences in participation by program, age, gender, or race/ethnicity. Low-income youth were less likely to participate (P=.002). Satisfaction in both programs was also high (3.9 of 5). There were significant gender, race/ethnicity, and income differences, in that girls (P=.001), black, Hispanic, or mixed race/ethnicity youth (P=.02), and low-income youth (P=.02) reported higher satisfaction. There were no
Stendell-Hollis, Nicole R; Laudermilk, Monica J; West, Julie L; Thompson, Patricia A; Thomson, Cynthia A
Recruitment and retention of lactating women require unique strategies to prevent high attrition. The purpose of this report is to identify successful recruitment strategies and evaluate demographic and lifestyle characteristics associated with study completion. A randomized, controlled trial was initiated to test the hypothesis that lactating women adhering to a Mediterranean diet will show a significant reduction in anthropometric measurements as compared to lactating women randomized to the USDA's MyPyramid diet for Pregnancy and Breastfeeding (control diet). Measurements were collected at baseline, 2 months, and 4 months. Recruitment methods and baseline characteristics of completers and non-completers are described. The largest percentage of women, 24.8%, were recruited from a local parenting magazine, 20.9% from Craig's List, 20.2% from local hospitals, and 34.1% from various other sources. At baseline, women (n = 129) were mostly Non-Hispanic (75.2%), average age 29.7 years, BMI averaged 27.2 kg/m(2), waist:hip ratio 0.84 cm (SD: 0.07), and body fat averaged 30.8%. Approximately 72% were exclusively breastfeeding, a mean 17.5 weeks postpartum, and 69.0% had a college degree. Non-completers were more likely to have supplemented with formula at baseline as compared to completers (Pwomen may consider "exclusive breastfeeding" as a study inclusion criterion to prevent high attrition rates or include additional breastfeeding support to study participants. Copyright © 2011 Elsevier Inc. All rights reserved.
Full Text Available Abstract Background Parents are the ones who decide whether or not to participate in parent focused prevention trials. Their decisions may be affected by internal factors (e.g., personality, attitudes, sociodemographic characteristics or external barriers. Some of these barriers are study-related and others are intervention-related. Internal as well as external barriers are especially important at the screening stage, which aims to identify children and families at risk and for whom the indicated prevention programs are designed. Few studies have reported their screening procedure in detail or analyzed differences between participants and dropouts or predictors of dropout. Rates of participation in prevention programs are also of interest and are an important contributor to the efficacy of a prevention procedure. Methods In this study, we analyzed the process of parent recruitment within an efficacy study of the indicated Prevention Program for Externalizing Problem behavior (PEP. We determined the retention rate at each step of the study, and examined differences between participants and dropouts/decliners. Predictors of dropout at each step were identified using logistic regression. Results Retention rates at the different steps during the course of the trial from screening to participation in the training ranged from 63.8% (pre-test to 81.1% (participation in more than 50% of the training sessions. Parents who dropped out of the study were characterized by having a child with lower symptom intensity by parent rating but higher ratings by teachers in most cases. Low socioeconomic status and related variables were also identified as predictors of dropout in the screening (first step and for training intensity (last step. Conclusions Special attention should be paid to families at increased risk for non-participation when implementing the prevention program in routine care settings. Trial Registration ISRCTN12686222
Facebook advertisements were used to recruit nulliparous women in the first 20 weeks of pregnancy for an online survey about their childbirth preferences. A campaign of ads was targeted to women, aged 18 to 44 years, residing in the United States. The ads were viewed 10,577,381 times by 7,248,985 unique Facebook users over 18 weeks in 2011. The ad campaign yielded 6,094 clicks by 5,963 unique users at a mean cost of $0.63 per click and a unique click-through rate of 0.08%. Of those who clicked through to the study site, 18% (n = 1,075) consented to participate. The participant pool was reduced to 344 women after application of strict eligibility criteria. Participants represented 43 states and the District of Columbia, their mean age was 20.9 years (Mdn = 19.0, SD = 4.0), and their mean weeks' gestation was 11.5 (SD = 5.8). The campaign cost was $3,821.81 or $11.11 per eligible participant. © 2013 Society for Public Health Education.
Kahan, Brennan C.
Background Patient recruitment in clinical trials is often challenging, and as a result, many trials are stopped early due to insufficient recruitment. The re-randomization design allows patients to be re-enrolled and re-randomized for each new treatment episode that they experience. Because it allows multiple enrollments for each patient, this design has been proposed as a way to increase the recruitment rate in clinical trials. However, it is unknown to what extent recruitment could be incr...
Bender, Jacqueline Lorene; Cyr, Alaina B; Arbuckle, Luk; Ferris, Lorraine E
mitigation strategies that we employed by assessing their alignment with PbD and by discussing the following: (1) What are the potential risks and who is at risk? (2) Is cancer considered "sensitive" personal information? (3) What is the probability of online disclosure of a cancer diagnosis in everyday life? and (4) What are the public's expectations for privacy online and their views about online tracking, profiling, and targeting? We conclude with a PbD framework for online health research recruitment. Researchers, REBs, ethicists, students, and potential study participants are often unaware of the privacy risks of social media research recruitment and there is no official guidance. Our PbD framework for online health research recruitment is a resource for these wide audiences.
Cyr, Alaina B; Arbuckle, Luk; Ferris, Lorraine E
the appropriateness of the risk mitigation strategies that we employed by assessing their alignment with PbD and by discussing the following: (1) What are the potential risks and who is at risk? (2) Is cancer considered “sensitive” personal information? (3) What is the probability of online disclosure of a cancer diagnosis in everyday life? and (4) What are the public’s expectations for privacy online and their views about online tracking, profiling, and targeting? We conclude with a PbD framework for online health research recruitment. Conclusions Researchers, REBs, ethicists, students, and potential study participants are often unaware of the privacy risks of social media research recruitment and there is no official guidance. Our PbD framework for online health research recruitment is a resource for these wide audiences. PMID:28385682
Mindell, Jennifer S; Giampaoli, Simona; Goesswald, Antje; Kamtsiuris, Panagiotis; Mann, Charlotte; Männistö, Satu; Morgan, Karen; Shelton, Nicola J; Verschuren, W M Monique; Tolonen, Hanna
Health examination surveys (HESs), carried out in Europe since the 1950's, provide valuable information about the general population's health for health monitoring, policy making, and research. Survey participation rates, important for representativeness, have been falling. International comparisons are hampered by differing exclusion criteria and definitions for non-response. Information was collected about seven national HESs in Europe conducted in 2007-2012. These surveys can be classified into household and individual-based surveys, depending on the sampling frames used. Participation rates of randomly selected adult samples were calculated for four survey modules using standardised definitions and compared by sex, age-group, geographical areas within countries, and over time, where possible. All surveys covered residents not just citizens; three countries excluded those in institutions. In two surveys, physical examinations and blood sample collection were conducted at the participants' home; the others occurred at examination clinics. Recruitment processes varied considerably between surveys. Monetary incentives were used in four surveys. Initial participation rates aged 35-64 were 45% in the Netherlands (phase II), 54% in Germany (new and previous participants combined), 55% in Italy, and 65% in Finland. In Ireland, England and Scotland, household participation rates were 66%, 66% and 63% respectively. Participation rates were generally higher in women and increased with age. Almost all participants attending an examination centre agreed to all modules but surveys conducted in the participants' home had falling responses to each stage. Participation rates in most primate cities were substantially lower than the national average. Age-standardized response rates to blood pressure measurement among those aged 35-64 in Finland, Germany and England fell by 0.7-1.5 percentage points p.a. between 1998-2002 and 2010-2012. Longer trends in some countries show a more
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
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
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
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.
Nicklas, Jacinda M; Skurnik, Geraldine; Zera, Chloe A; Reforma, Liberty G; Levkoff, Sue E; Seely, Ellen W
The postpartum period is a window of opportunity for diabetes prevention in women with recent gestational diabetes (GDM), but recruitment for clinical trials during this period of life is a major challenge. We adapted a social-ecologic model to develop a multi-level recruitment strategy at the macro (high or institutional level), meso (mid or provider level), and micro (individual) levels. Our goal was to recruit 100 women with recent GDM into the Balance after Baby randomized controlled trial over a 17-month period. Participants were asked to attend three in-person study visits at 6 weeks, 6, and 12 months postpartum. They were randomized into a control arm or a web-based intervention arm at the end of the baseline visit at six weeks postpartum. At the end of the recruitment period, we compared population characteristics of our enrolled subjects to the entire population of women with GDM delivering at Brigham and Women's Hospital (BWH). We successfully recruited 107 of 156 (69 %) women assessed for eligibility, with the majority (92) recruited during pregnancy at a mean 30 (SD ± 5) weeks of gestation, and 15 recruited postpartum, at a mean 2 (SD ± 3) weeks postpartum. 78 subjects attended the initial baseline visit, and 75 subjects were randomized into the trial at a mean 7 (SD ± 2) weeks postpartum. The recruited subjects were similar in age and race/ethnicity to the total population of 538 GDM deliveries at BWH over the 17-month recruitment period. Our multilevel approach allowed us to successfully meet our recruitment goal and recruit a representative sample of women with recent GDM. We believe that our most successful strategies included using a dedicated in-person recruiter, integrating recruitment into clinical flow, allowing for flexibility in recruitment, minimizing barriers to participation, and using an opt-out strategy with providers. Although the majority of women were recruited while pregnant, women recruited in the early postpartum period were
Full Text Available The free and open publication of course materials (OpenCourseWare or OCW was initially undertaken by Massachusetts Institute of Technology (MIT and other universities primarily to share educational resources among educators (Abelson, 2007. OCW, however, and more in general open educational resources (OER1, have also provided well-documented opportunities for all learners, including the so-called “informal learners” and “independent learners” (Carson, 2005; Mulder, 2006, p. 35. Universities have also increasingly documented clear benefits for specific target groups such as secondary education students and lifelong learners seeking to enter formal postsecondary education programs.In addition to benefitting learners, OCW publication has benefitted the publishing institutions themselves by providing recruiting advantages. Finally enrollment figures from some institutions indicate that even in the case of the free and open publication of materials from online programs, OCW does not negatively affect enrollment. This paper reviews evaluation conducted at Massachusetts Institute of Technology, Johns Hopkins Bloomberg School of Public Health (JHSPH, and Open Universiteit Nederland (OUNL concerning OCW effects on higher education participation and student recruitment.
Full Text Available Abstract Background Recruitment to randomized controlled trials is known to be challenging. It is important to understand and identify predictors of good or poor accrual to a clinical trial so that appropriate strategies can be put in place to overcome these problems and facilitate successful trial completion. We have developed a survey tool to establish the recruitment experience of clinical teams regarding facilitators and barriers to recruitment in a clinical trial and describe herein the method of developing the questionnaire. Methods A literature search was conducted to identify studies that have explored facilitators and barriers to recruitment, and a list of potential factors affecting recruitment to a clinical trial was generated. These factors were categorized in terms relating to the (i trial, (ii site, (iii patient, (iv clinical team, (v information and consent and (vi study team. A list was provided for responders to grade these factors as weak, intermediate or strong facilitators or barriers to recruitment. Results A web-based survey questionnaire was developed. This survey was designed to establish the recruitment experience of clinical teams with regard to the perceived facilitators and barriers to recruitment, to identify strategies applied to overcome these problems, and to obtain suggestions for change in the organization of future trials. The survey tool can be used to assess the recruitment experience of clinical teams in a single/multicenter trial in any clinical setting or speciality involving adults or children either in an ongoing trial or at trial completion. The questionnaire is short, easy to administer and to complete, with an estimated completion time of 11 minutes. Conclusions We have presented a robust methodology for developing this survey tool that provides an evidence-based list of potential factors that can affect recruitment to a clinical trial. We recommend that all clinical trialists should consider using
Lord, P; Willis, T; Carder, P; West, R; Foy, RC
Background: Recruitment of representative samples in primary care research is essential to ensure high-quality, generalisable results. This is particularly important for research using routinely recorded patient data to examine the delivery of care. Yet little is known about how different recruitment strategies influence the characteristics of the practices included in research. We describe three approaches for recruiting practices to data sharing studies, examining differences in recruitment...
Ammari, ABH; Hendriksen, Carsten; Rydahl Hansen, Susan
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......Cancer patients and their family caregivers need support to cope with physical, psychosocial, and existential problems early in the palliative care trajectory. Many interventions target patient symptomatology, with health care professionals acting as problem-solvers. Family coping, however...... 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...
Ritter, Jessica A
The social work literature is replete with studies evaluating social workers' direct practice interventions, but strikingly few have assessed how well social workers are faring in the political arena. This study tests a major theoretical model, the civic voluntarism model, developed to explain why some citizens become involved in politics, whereas others do not. The study sample consisted of 396 randomly selected social workers licensed in 11 states, all of whom completed a 25-minute telephone survey. Social workers were surveyed to determine the role of the following variables in explaining social workers' political activity levels-resources needed to participate, psychological engagement, and attachment to recruitment networks. The results indicate that the civic voluntarism model was significant and accounted for 42 percent of the variance. The strongest predictors of social workers' political activity were NASW membership and political interest. This study provides empirical support for the idea that being connected to social networks and having a psychological engagement with politics are crucial factors in explaining social workers' political participation. Implications for social work education are included.
Ammari, Anne Birgitte Hjuler; Hendriksen, Carsten; Rydahl-Hansen, Susan
Cancer patients and their family caregivers need support to cope with physical, psychosocial, and existential problems early in the palliative care trajectory. Many interventions target patient symptomatology, with health care professionals acting as problem-solvers. Family coping, however, is a new research area within palliative care. The FamCope intervention was developed to test if a nurse-led family-coping-orientated palliative home care intervention would help families cope with physical and psychosocial problems at home--together as a family and in interaction with health care 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 is too great" and, second, that it was "too soon" to receive this kind of support. Men were more likely to participate than women. Patients in the "too soon" group had similar characteristics to participants in the trial. Timing of interventions and readiness of patients and their relatives seems to affect willingness to receive a family-coping-orientated care approach and impeded recruitment to this trial. Our findings can be used in further research and in clinical
Close, Sharron; Smaldone, Arlene; Fennoy, Ilene; Reame, Nancy; Grey, Margaret
Recruiting pediatric samples for research may be challenging due to parental mistrust of the research process, privacy concerns, and family time constraints. Recruitment of children with chronic and genetic conditions may further complicate the enrollment process. In this paper, we describe the methodological challenges of recruiting children for research and provide an exemplar of how the use of information technology (IT) strategies with social networking may improve access to difficult-to-reach pediatric research participants. We conducted a cross-sectional descriptive study of boys between the ages of 8 and 18 years with Klinefelter syndrome. This study presented unique challenges for recruitment of pediatric participants. These challenges are illustrated by the report of recruitment activities developed for the study. We reviewed the literature to explore the issues of recruiting children for research using conventional and IT approaches. Success rates of conventional recruitment approaches, such as brochures, flyers in medical offices, and physician referrals, are compared with IT-based outreach. The IT approaches included teleconferencing via a Klinefelter syndrome support group, services of a Web-based commercial recruitment-matching company, and the development of a university-affiliated research recruitment website with the use of paid advertising on a social networking website (Facebook). Over a 3-month period, dissemination of over 150 recruitment brochures and flyers placed in a large urban hospital and hospital-affiliated clinical offices, with 850 letters to physicians and patients were not successful. Within the same period, face-to-face recruitment in the clinical setting yielded 4 (9%) participants. Using Web-based and social networking approaches, 39 (91%) agreed to participate in the study. With these approaches, 5 (12%) were recruited from the national Klinefelter syndrome advocacy group, 8 (19%) from local and teleconference support groups, 10
Akmatov, Manas K; Rübsamen, Nicole; Schultze, Anja; Kemmling, Yvonne; Obi, Nadia; Günther, Kathrin; Ahrens, Wolfgang; Pessler, Frank; Krause, Gérard; Mikolajczyk, Rafael T
We compared participation and compliance with a web-based data collection on infections among population-based samples recruited in different ways. Individuals were recruited from participants in the German National Cohort study (Group A, n = 279) or persons who were invited to this study but did not participate (Group B, n = 53). A third group was invited to the web-based study only (Group C, n = 145). Response varied among groups between 3 % (B), 11 % (C) and 61 % (A), but compliance was similar (81-85 %). Response did not differ by age and sex. Compliance was lower among the youngest and oldest participants. In addition, participants currently not employed were more likely to have better compliance. Semi-parametric group-based modelling identified three distinct compliance trajectories; "poor compliance" (8 %), "improving compliance" (14 %) and "very good compliance" (78 %). Participation differed among modes of recruitment, but compliance was similar among groups and notably high. Different recruitment approaches can be used and collected data can be combined to achieve greater sample sizes for longitudinal web-based studies.
Subasinghe, Asvini K; Nguyen, Margaret; Wark, John D; Tabrizi, Sepehr N; Garland, Suzanne M
Targeted advertising using social networking sites (SNS) as a recruitment strategy in health research is in its infancy. The aim of this study was to determine the feasibility of targeted Facebook advertisements to increase recruitment of unvaccinated women into a human papillomavirus (HPV) vaccine effectiveness study. Between September 2011 and November 2013, females aged 18 to 25 years, residing in Victoria, Australia, were recruited through Facebook advertisements relating to general women's health. From November 2013 to June 2015, targeted advertising campaigns were implemented to specifically recruit women who had not received the HPV vaccine. Consenting participants were invited to complete an online questionnaire and those who had ever had sexual intercourse were asked to provide a self-collected vaginal swab. The HPV vaccination status of participants was confirmed from the National HPV Vaccination Program Register (NHVPR). The campaign comprised 10 advertisements shown between September 2011 and June 2015 which generated 55,381,637 impressions, yielding 23,714 clicks, at an overall cost of AUD $22,078.85. A total of 919 participants were recruited. A greater proportion of unvaccinated women (50.4%, 131/260) were recruited into the study following targeted advertising, compared with those recruited (19.3%, 127/659) prior to showing the modified advertisement (P<.001). A greater proportion of the total sample completed tertiary education and resided in inner regional Victoria, compared with National population census data (P<.001), but was otherwise representative of the general population. Targeted Facebook advertising is a rapid and cost-effective way of recruiting young unvaccinated women into a HPV vaccine effectiveness study.
Killawi, Amal; Khidir, Amal; Elnashar, Maha; Abdelrahim, Huda; Hammoud, Maya; Elliott, Heather; Thurston, Michelle; Asad, Humna; Al-Khal, Abdul Latif; Fetters, Michael D
Very few researchers have reported on procedures of recruiting, obtaining informed consent, and compensating participants in health research in the Arabian Gulf Region. Empirical research can inform the debate about whether to adjust these procedures for culturally diverse settings. Our objective was to delineate procedures related to recruiting, obtaining informed consent, and compensating health research participants in the extremely high-density multicultural setting of Qatar. During a multistage mixed methods project, field observations and qualitative interviews were conducted in a general medicine clinic of a major medical center in Qatar. Participants were chosen based on gender, age, literacy, and preferred language, i.e., Arabic, English, Hindi and Urdu. Qualitative analysis identified themes about recruitment, informed consent, compensation, and other research procedures. A total of 153 individuals were approached and 84 enrolled; the latter showed a diverse age range (18 to 75 years); varied language representation: Arabic (n = 24), English (n = 20), Hindi (n = 20), and Urdu (n = 20); and balanced gender distribution: women (n = 43) and men (n = 41). Primary reasons for 30 declinations included concern about interview length and recording. The study achieved a 74% participation rate. Qualitative analytics revealed key themes about hesitation to participate, decisions about participation with family members as well as discussions with them as "incidental research participants", the informed consent process, privacy and gender rules of the interview environment, reactions to member checking and compensation, and motivation for participating. Vulnerability emerged as a recurring issue throughout the process among a minority of participants. This study from Qatar is the first to provide empirical data on recruitment, informed consent, compensation and other research procedures in a general adult population in the Middle East and Arabian Gulf. This
Vemulakonda, Vijaya M; Jones, Jacqueline
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 ethical research by both parents and providers. While some parents are open to participation in surgical RCTs, providers and parents of children with hydronephrosis feel discomfort with the element of chance in surgical randomized trials. Parents and providers are more likely to participate in observational studies where treatment decisions may be made jointly by the physician and the parent. These findings suggest that pragmatic trial strategies with the option for participation in an observational cohort may improve recruitment of pediatric patients into surgical clinical trials. Copyright © 2015 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.
Juraschek, Stephen P; Plante, Timothy B; Charleston, Jeanne; Miller, Edgar R; Yeh, Hsin-Chieh; Appel, Lawrence J; Jerome, Gerald J; Gayles, Debra; Durkin, Nowella; White, Karen; Dalcin, Arlene; Hermosilla, Manuel
Despite widespread Internet adoption, online advertising remains an underutilized tool to recruit participants into clinical trials. Whether online advertising is a cost-effective method to enroll participants compared to other traditional forms of recruitment is not known. Recruitment for the Survivorship Promotion In Reducing IGF-1 Trial, a community-based study of cancer survivors, was conducted from June 2015 through December 2016 via in-person community fairs, advertisements in periodicals, and direct postal mailings. In addition, "Right Column" banner ads were purchased from Facebook to direct participants to the Survivorship Promotion In Reducing IGF-1 Trial website. Response rates, costs of traditional and online advertisements, and demographic data were determined and compared across different online and traditional recruitment strategies. Micro-trials optimizing features of online advertisements were also explored. Of the 406 respondents to our overall outreach efforts, 6% (24 of 406) were referred from online advertising. Facebook advertisements were shown over 3 million times (impressions) to 124,476 people, which resulted in 4401 clicks on our advertisement. Of these, 24 people ultimately contacted study staff, 6 underwent prescreening, and 4 enrolled in the study. The cost of online advertising per enrollee was $794 when targeting a general population versus $1426 when accounting for strategies that specifically targeted African Americans or men. By contrast, community fairs, direct mail, or periodicals cost $917, $799, or $436 per enrollee, respectively. Utilization of micro-trials to assess online ads identified subtleties (e.g. use of an advertisement title) that substantially impacted viewer interest in our trial. Online advertisements effectively directed a relevant population to our website, which resulted in new enrollees in the Survivorship Promotion In Reducing IGF-1 Trial at a cost comparable to traditional methods. Costs were
Thomas, Avis J; Bainbridge, Heather A; Schone, Joyce L; Chen, Shu-Chun; Connett, John E; Ikramuddin, Sayeed; Lee, Wei-Jei; Jensen, Michael D; Leslie, Daniel B; Korner, Judith
Large-scale randomized clinical trials are needed to assess the role of Roux-en-Y gastric bypass (RYGB) in treating patients with type 2 diabetes mellitus (T2DM). Recruitment challenges must be understood. One hundred twenty participants were needed for a prospective randomized controlled trial investigating treatments for hyperglycemia and cardiovascular disease risk factors in patients with T2DM. The trial had two arms-intensive medical management plus a rigorous lifestyle intervention (LS/IMM) versus LS/IMM with RYGB. Medical inclusion criteria included glycosylated hemoglobin (HbA1c) ≥ 8.0 % while under the care of a physician and body mass index (BMI) 30.0-39.9 kg/m(2). Another inclusion criterion was expressed willingness to accept randomization and participate fully. Varied recruitment strategies were employed at four academic hospitals in the USA and Taiwan, including referrals, mass media, direct mail to patients drawn from a practice-based database, and direct mail to commercial mailing lists. Between February 2008 and December 2011, 2,648 candidates were phone-screened and 240 were screened on site; 120 participants were eventually randomized. Impediments included stringent medical inclusion criteria and a lack of equipoise (i.e., strong beliefs or preferences) among patients and their personal community-based physicians. To meet timeline requirements, the upper limit for BMI was increased from 34.9 to 39.9 kg/m(2) and an additional site was added. We successfully recruited 120 participants with poorly controlled T2DM and mild to moderate obesity. Participants had to be willing to accept randomization to either surgical or nonsurgical treatments. Recruitment took 4 years.
Tehranisa, Jason S; Meurer, William J
A response-adaptive randomization (RAR) trial design actively adjusts the ratio of participants assigned to each trial arm, favoring the better performing treatment by using outcome data from participants already in the trial. Compared with a standard clinical trial, an RAR study design has the potential to improve patient participation in acute stroke trials. This cross-sectional randomized survey included adult emergency department patients, age≥18, without symptoms of stroke or other critical illness. A standardized protocol was used, and subjects were randomized to either an RAR or standard hypothetical acute stroke trial. After viewing the video describing the hypothetical trial (http://youtu.be/cKIWduCaPZc), reviewing the consent form, and having questions answered, subjects indicated whether they would consent to the trial. A multivariable logistic regression model was fitted to estimate the impact of RAR while controlling for demographic factors and patient understanding of the design. A total of 418 subjects (210 standard and 208 RAR) were enrolled. All baseline characteristics were balanced between groups. There was significantly higher participation in the RAR trial (67.3%) versus the standard trial (54.5%), absolute increase: 12.8% (95% confidence interval, 3.7-22.2). The RAR group had a higher odds ratio of agreeing to research (odds ratio, 1.89; 95% confidence interval, 1.2-2.9) while adjusting for patient level factors. Trial designs were generally well understood by the participants. The hypothetical RAR trial attracted more research participation than standard randomization. RAR has the potential to increase recruitment and offer benefit to future trial participants. © 2014 American Heart Association, Inc.
van Straten Annemieke
Full Text Available Abstract Background Although indicated prevention of depression is available for about 80% of the Dutch population at little or no cost, only a small proportion of those with subthreshold depression make use of these services. Methods A narrative review is conducted of the Dutch preventive services in mental health care, also addressing the problem of low participation rates. We describe possible causes of these low participation rates, which may be related to the participants themselves, the service system, and the communication to the public, and we put forward possible solutions to this problem. Results There are three main groups of reasons why the participation rates are low: reasons within the participants (e.g., not considering themselves as being at risk; thinking the interventions are not effective; or being unwilling to participate because of the stigma associated with depression; reasons within the health care system; and reasons associated with the communication about the preventive services. Possible solutions to increasing the participation rate include organizing mass media campaigns, developing internet-based preventive interventions, adapting preventive interventions to the needs of specific subpopulations, positioning the services in primary care, integrating the interventions in community-wide interventions, and systematically screening high-risk groups for potential participants. Discussion Prevention could play an important role in public mental health in reducing the enormous burden of depression. However, before this can be realized more research is needed to explore why participation rates are low and how these rates can be improved.
Yuan, Patrick; Bare, Michael G; Johnson, Mallory O
Background There are many challenges in recruiting and engaging participants when conducting research, especially with HIV-positive individuals. Some of these challenges include geographical barriers, insufficient time and financial resources, and perceived HIV-related stigma. Objective This paper describes the methodology of a recruitment approach that capitalized on existing online social media venues and other Internet resources in an attempt to overcome some of these barriers to research recruitment and retention. Methods From May through August 2013, a campaign approach using a combination of online social media, non-financial incentives, and Web-based survey software was implemented to advertise, recruit, and retain participants, and collect data for a survey study with a limited budget. Results Approximately US $5,000 was spent with a research staff designated at 20% of full-time effort, yielding 2034 survey clicks, 1404 of which met the inclusion criteria and initiated the survey, for an average cost of US $3.56 per survey initiation. A total of 1221 individuals completed the survey, yielding 86.97% retention. Conclusions These data indicate that online recruitment is a feasible and efficient tool that can be further enhanced by sophisticated online data collection software and the addition of non-financial incentives. PMID:24784982
Franciscus, Margaret; Nucci, Anita; Bradley, Brenda
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...... 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......-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...
Sikkens, E.; San, M. van; Sieckelinck, S.; Boeije, H.; Winter, M. de
Social media are useful facilitators when recruiting hidden populations for research. In our research on youth and radicalization, we were able to find and contact young people with extreme ideals through Facebook. In this article, we discuss our experiences using Facebook as a tool for finding
Sikkens, E.M.; van San, M.R.P.J.R.S.; Sieckelinck, S.M.A.; Boeije, H.R.; de Winter, M.
Social media are useful facilitators when recruiting hidden populations for research. In our research on youth and radicalization, we were able to find and contact young people with extreme ideals through Facebook. In this article, we discuss our experiences using Facebook as a tool for finding
Ntiri, Daphne W.; Stewart, Merry
This article reviews the challenges encountered in the recruitment of urban older African-Americans in a study to explore the effects of interactive educational intervention on functional health literacy and diabetes knowledge. Our methods included identification of challenges related to the individual characteristics of seniors' centers that…
Sikkens, Elga; van San, Marion; Sieckelinck, Stijn; Boeije, Hennie; de Winter, Micha
Social media are useful facilitators when recruiting hidden populations for research. In our research on youth and radicalization, we were able to find and contact young people with extreme ideals through Facebook. In this article, we discuss our experiences using Facebook as a tool for finding respondents who do not trust researchers. Facebook…
Balestracci, Kate; Wong, Annette TY; Hebden, Lana; McGeechan, Kevin; Denney-Wilson, Elizabeth; Harris, Mark F; Phongsavan, Philayrath; Bauman, Adrian; Allman-Farinelli, Margaret
Background Younger adults are difficult to engage in preventive health, yet in Australia they are gaining more weight and increasing in waist circumference faster than middle-to-older adults. A further challenge to engaging 18- to 35-year-olds in interventions is the limited reporting of outcomes of recruitment strategies. Objective This paper describes the outcomes of strategies used to recruit young adults to a randomized controlled trial (RCT), healthy lifestyle mHealth program, TXT2BFiT, for prevention of weight gain. The progression from enquiry through eligibility check to randomization into the trial and the costs of recruitment strategies are reported. Factors associated with nonparticipation are explored. Methods Participants were recruited either via letters of invitation from general practitioners (GPs) or via electronic or print advertisements, including Facebook and Google—social media and advertising—university electronic newsletters, printed posters, mailbox drops, and newspapers. Participants recruited from GP invitation letters had an appointment booked with their GP for eligibility screening. Those recruited from other methods were sent an information pack to seek approval to participate from their own GP. The total number and source of enquiries were categorized according to eligibility and subsequent completion of steps to enrolment. Cost data and details of recruitment strategies were recorded. Results From 1181 enquiries in total from all strategies, 250 (21.17%) participants were randomized. A total of 5311 invitation letters were sent from 12 GP practices—16 participating GPs. A total of 131 patients enquired with 68 participants randomized (68/74 of those eligible, 92%). The other recruitment methods yielded the remaining 182 randomized participants. Enrolment from print media was 26% of enquiries, from electronic media was 20%, and from other methods was 3%. Across all strategies the average cost of recruitment was Australian Dollar
Partridge, Stephanie R; Balestracci, Kate; Wong, Annette Ty; Hebden, Lana; McGeechan, Kevin; Denney-Wilson, Elizabeth; Harris, Mark F; Phongsavan, Philayrath; Bauman, Adrian; Allman-Farinelli, Margaret
Younger adults are difficult to engage in preventive health, yet in Australia they are gaining more weight and increasing in waist circumference faster than middle-to-older adults. A further challenge to engaging 18- to 35-year-olds in interventions is the limited reporting of outcomes of recruitment strategies. This paper describes the outcomes of strategies used to recruit young adults to a randomized controlled trial (RCT), healthy lifestyle mHealth program, TXT2BFiT, for prevention of weight gain. The progression from enquiry through eligibility check to randomization into the trial and the costs of recruitment strategies are reported. Factors associated with nonparticipation are explored. Participants were recruited either via letters of invitation from general practitioners (GPs) or via electronic or print advertisements, including Facebook and Google-social media and advertising-university electronic newsletters, printed posters, mailbox drops, and newspapers. Participants recruited from GP invitation letters had an appointment booked with their GP for eligibility screening. Those recruited from other methods were sent an information pack to seek approval to participate from their own GP. The total number and source of enquiries were categorized according to eligibility and subsequent completion of steps to enrolment. Cost data and details of recruitment strategies were recorded. From 1181 enquiries in total from all strategies, 250 (21.17%) participants were randomized. A total of 5311 invitation letters were sent from 12 GP practices-16 participating GPs. A total of 131 patients enquired with 68 participants randomized (68/74 of those eligible, 92%). The other recruitment methods yielded the remaining 182 randomized participants. Enrolment from print media was 26% of enquiries, from electronic media was 20%, and from other methods was 3%. Across all strategies the average cost of recruitment was Australian Dollar (AUD) $139 per person. The least expensive
Miguel, Alexander; Hall, Anna; Liu, Wei; Garrett, Jeremy; Ballew, Angel; Yang, Tsu-Hsaun; Segal, Richard
The Centers for Medicare & Medicaid Services (CMS) require prescription drug plan sponsors to offer a comprehensive medication review (CMR) annually to eligible beneficiaries through the plans' Medication Therapy Management Programs (MTMPs). In 2011, the Pharmacy Quality Alliance endorsed the CMR completion rate as a quality measure for MTMPs, and CMS has adopted the measure into the 2016 CMS star ratings. CMS star ratings are used to describe the quality of plans to assist Medicare plan enrollees in choosing a plan and to determine quality bonus payments for Medicare Advantage plans. Star ratings are measured on a scale of 1 to 5, with 5 being the highest possible rating for an individual measure. Currently, the majority of plans score 2 stars or less on the CMR completion rate measure. To demonstrate the effectiveness of a standardized CMR recruitment script emphasizing the benefits of the service to increase acceptance of CMR offers among beneficiaries of a Medicare prescription drug plan. A CMR recruitment script, shaped by the Health Belief Model, was developed based on a previous pilot study. The original script described the CMR service but did not emphasize key benefits or barriers from the beneficiary perspective. The updated script aimed to enhance beneficiary understanding of the CMR service, explain the benefits from the beneficiary perspective, and address potential barriers to accepting the service. The updated script was tested during the 2012 MTMP enrollment in a randomized controlled experiment, using the original script as the control. The CMR service was offered to MTMP members via phone calls by live call agents who spoke with members who answered, using 1 of the 2 scripts. Both scripts asked members if they were willing to have a pharmacist call them back and perform a CMR at a later date. Two call attempts were made to all eligible beneficiaries. If contact was not made after 2 unsuccessful outreach attempts, a computer-generated voicemail
Ferris, Maria; Norwood, Victoria; Radeva, Milena; Gassman, Jennifer J; Al-Uzri, Amira; Askenazi, David; Matoo, Tej; Pinsk, Maury; Sharma, Amita; Smoyer, William; Stults, Jenna; Vyas, Shefali; Weiss, Robert; Gipson, Debbie; Kaskel, Frederick; Friedman, Aaron; Moxey-Mims, Marva; Trachtman, Howard
We describe the experience of the focal segmental glomerulosclerosis clinical trial (FSGS CT) in the identification and recruitment of participants into the study. This National Institutes of Health funded study, a multicenter, open-label, randomized comparison of cyclosporine versus oral dexamethasone pulses plus mycophenolate mofetil, experienced difficulty and delays meeting enrollment goals. These problems occurred despite the support of patient advocacy groups and aggressive recruitment strategies. Multiple barriers were identified including: (1) inaccurate estimates of the number of potential incident FSGS patients at participating centers; (2) delays in securing one of the test agents; (3) prolonged time between IRB approval and execution of a subcontract (mean 7.5 ± 0.8 months); (4) prolonged time between IRB approval and enrollment of the first patient at participating sites (mean 19.6 ± 1.4 months); and (5) reorganization of clinical coordinating core infrastructure to align resources with enrollment. A Web-based anonymous survey of site investigators revealed site-related barriers to patient recruitment. The value of a variety of recruitment tools was of marginal utility in facilitating patient enrollment. We conclude that improvements in the logistics of study approval and regulatory start-up and testing of promising novel agents are important factors in promoting enrollment into randomized clinical trials in nephrology. © 2013 Wiley Periodicals, Inc.
Hunt Katherine J
Full Text Available Abstract Background Although in health services survey research we strive for a high response rate, this must be balanced against the need to recruit participants ethically and considerately, particularly in surveys with a sensitive nature. In survey research there are no established recommendations to guide recruitment approach and an ‘opt-in’ system that requires potential participants to request a copy of the questionnaire by returning a reply slip is frequently adopted. However, in observational research the risk to participants is lower than in clinical research and so some surveys have used an ‘opt-out’ system. The effect of this approach on response and distress is unknown. We sought to investigate this in a survey of end of life care completed by bereaved relatives. Methods Out of a sample of 1422 bereaved relatives we assigned potential participants to one of two study groups: an ‘opt in’ group (n=711 where a letter of invitation was issued with a reply slip to request a copy of the questionnaire; or an ‘opt out’ group (n=711 where the survey questionnaire was provided alongside the invitation letter. We assessed response and distress between groups. Results From a sample of 1422, 473 participants returned questionnaires. Response was higher in the ‘opt out’ group than in the ‘opt in’ group (40% compared to 26.4%: χ2 =29.79, p-value2=28.60, p-value Conclusion Given that the ‘opt out’ method of recruitment is associated with a higher response than the ‘opt in’ method, seems to have no impact on complaints or distress about the survey, and there are differences in the patterns of responses between groups, the ‘opt out’ method could be recommended as the most efficient way to recruit into surveys, even in those with a sensitive nature.
Facebook advertisements were used to recruit nulliparous women in the first 20 weeks of pregnancy for an online survey about their childbirth preferences. A campaign of ads was targeted to women, aged 18 to 44 years, residing in the United States. The ads were viewed 10,577,381 times by 7,248,985 unique Facebook users over 18 weeks in 2011. The ad…
Jones, Ray B; Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J
Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues. We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies. Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting "leaked" and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations. Measuring the impact on LLTTF use was
Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J
Background Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. Objective To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues. Methods We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies. Results Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting “leaked” and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations
Luzurier, Quentin; Damm, Cédric; Lion, Fabien; Daniel, Carine; Pellerin, Lucille; Tavolacci, Marie-Pierre
The aim was to describe a strategy for recruitment of healthy volunteers (HV) to a randomized trial that assessed the efficacy of different telephone techniques to assist HV in performing cardiac massage for vital emergency. Participation in the randomized trial was not financially compensated, however HV were offered emergency first-aid training. We also studied factors associated with HV motivation and satisfaction regarding participation in the trial. Strategy for recruitment of 210 HV aged 18 to 60 years was based on: (1) the updated records of all telephone number since January 2000 of HV registered in the Rouen Clinical Investigation Centre HV database, (2) a communication campaign for the general public focussing on posters and media advertisements. Data on the recruitment, socio-demographics, motivation and satisfaction of the 210 HV were collected by anonymous self-administered questionnaire. Of the 210 HV included, 63.3% (n = 133) were recruited from the HV database and 36.7% (n = 77) by the communication campaign. On the one hand, the HV database enabled screening of 1315 HV, 54.8% (n = 721) of whom were reached by phone, 55.2% (n = 398) of these latter accepted to participate in the study and 10.1% of the initial screening (n = 133) were finally included. One the other hand, for the 77 HV not recruited from the HV database, word-of-mouth (56.1%) was the main means of recruitment. The male/female ratio of the 210 HV was 0.5 and mean age 43.5 years (Standard Deviation = 12.4). The main motivations given for participating in the trial were to support research (87.6%) and receive emergency first-aid training (85.7%). Overall satisfaction with the welcome process was significantly higher for older HV (46-60 years) (adjusted odds ratio (AOR): 3.44; 95% confidence interval (95% CI): 1.48-7.99), and for HV in management jobs (AOR: 4.26; 95% CI: 1.22-14.87). Satisfaction with protocol management was higher for women (AOR: 2.33; 95% CI: 1
Loskutova, Natalia Y; Smail, Craig; Ajayi, Kemi; Pace, Wilson D; Fox, Chester H
We assessed the challenging process of recruiting primary care practices in a practice-based research study. In this descriptive case study of recruitment data collected for a large practice-based study (TRANSLATE CKD), 48 single or multiple-site health care organizations in the USA with a total of 114 practices were invited to participate. We collected quantitative and qualitative measures of recruitment process and outcomes for the first 25 practices recruited. Information about 13 additional practices is not provided due to staff transitions and limited data collection resources. Initial outreach was made to 114 practices (from 48 organizations, 41% small); 52 (45%) practices responded with interest. Practices enrolled in the study (n = 25) represented 22% of the total outreach number, or 48% of those initially interested. Average time to enroll was 71 calendar days (range 11-107). There was no difference in the number of days practices remained under recruitment, based on enrolled versus not enrolled (44.8 ± 30.4 versus 46.8 ± 25.4 days, P = 0.86) or by the organization size, i.e. large versus small (defined by having ≤4 distinct practices; 52 ± 23.6 versus 43.6 ± 27.8 days; P = 0.46). The most common recruitment barriers were administrative, e.g. lack of perceived direct organizational benefit, and were more prominent among large organizations. Despite the general belief that the research topic, invitation method, and interest in research may facilitate practice recruitment, our results suggest that most of the recruitment challenges represent managerial challenges. Future research projects may need to consider relevant methodologies from businesses administration and marketing fields.
Full Text Available Mauro Cortellini, Franco Berrino, Patrizia Pasanisi Department of Preventive & Predictive Medicine, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy Abstract: Among randomized controlled trials (RCTs, trials for primary prevention require large samples and long follow-up to obtain a high-quality outcome; therefore the recruitment process and the drop-out rates largely dictate the adequacy of the results. We are conducting a Phase III trial on persons with metabolic syndrome to test the hypothesis that comprehensive lifestyle changes and/or metformin treatment prevents age-related chronic diseases (the MeMeMe trial, EudraCT number: 2012-005427-32, also registered on ClinicalTrials.gov [NCT02960711]. Here, we briefly analyze and discuss the reasons which may lead to participants dropping out from trials. In our experience, participants may back out of a trial for different reasons. Drug-induced side effects are certainly the most compelling reason. But what are the other reasons, relating to the participants’ perception of the progress of the trial which led them to withdraw after randomization? What about the time-dependent drop-out rate in primary prevention trials? The primary outcome of this analysis is the point of drop-out from trial, defined as the time from the randomization date to the withdrawal date. Survival functions were non-parametrically estimated using the product-limit estimator. The curves were statistically compared using the log-rank test (P=0.64, not significant. Researchers involved in primary prevention RCTs seem to have to deal with the paradox of the proverbial “short blanket syndrome”. Recruiting only highly motivated candidates might be useful for the smooth progress of the trial but it may lead to a very low enrollment rate. On the other hand, what about enrolling all the eligible subjects without considering their motivation? This might boost the enrollment rate, but it can lead to biased
Textor, Johannes; Henrickson, Sarah E; Mandl, Judith N; von Andrian, Ulrich H; Westermann, Jürgen; de Boer, Rob J; Beltman, Joost B
To fight infections, rare T cells must quickly home to appropriate lymph nodes (LNs), and reliably localize the antigen (Ag) within them. The first challenge calls for rapid trafficking between LNs, whereas the second may require extensive search within each LN. Here we combine simulations and experimental data to investigate which features of random T cell migration within and between LNs allow meeting these two conflicting demands. Our model indicates that integrating signals from multiple random encounters with Ag-presenting cells permits reliable detection of even low-dose Ag, and predicts a kinetic feature of cognate T cell arrest in LNs that we confirm using intravital two-photon data. Furthermore, we obtain the most reliable retention if T cells transit through LNs stochastically, which may explain the long and widely distributed LN dwell times observed in vivo. Finally, we demonstrate that random migration, both between and within LNs, allows recruiting the majority of cognate precursors within a few days for various realistic infection scenarios. Thus, the combination of two-scale stochastic migration and signal integration is an efficient and robust strategy for T cell immune surveillance.
Schjoedt, Uffe; Stødkilde-Jørgensen, Hans; Geertz, Armin W; Roepstorff, Andreas
We used functional magnetic resonance imaging (fMRI) to investigate how performing formalized and improvised forms of praying changed the evoked BOLD response in a group of Danish Christians. Distinct from formalized praying and secular controls, improvised praying activated a strong response in the temporopolar region, the medial prefrontal cortex, the temporo-parietal junction and precuneus. This finding supports our hypothesis that religious subjects, who consider their God to be 'real' and capable of reciprocating requests, recruit areas of social cognition when they pray. We argue that praying to God is an intersubjective experience comparable to 'normal' interpersonal interaction.
Ramos, Juan David Hincapie
The Mini-Grid is a volunteer computing infrastructure that gathers computational power from multiple participants and uses it to execute bio-informatics algorithms. The Mini-Grid is an instance of a larger set of systems that I call participative computational infrastructures (PCI). PCIs depend...
Rosal, Milagros C; White, Mary Jo; Borg, Amy; Scavron, Jeffrey; Candib, Lucy; Ockene, Ira; Magner, Robert
To describe methods used to recruit and retain low-income Latinos in a randomized clinical trial (RCT) of a diabetes self-management intervention at 5 community health centers (CHCs) in Massachusetts. Consent from primary care providers (PCPs) was obtained to screen their patients. Trained site research coordinators (SRCs) screened, recruited, and enrolled participants following a multistep process (medical record reviews, PCP approval, a patient eligibility interview) and provided support for retention efforts. Assessment staff were trained in motivational strategies to facilitate retention and received ongoing support from a retention coordinator. Electronic tracking systems facilitated recruitment and retention activities. Of an initial pool of 1176 patients, 1034 were active at the time of screening, 592 (57%) were eligible by medical record review, and 487 received PCP approval (92% of reviewed patients). Of these, 293 patients completed the patient screening interview (60% of patients with PCP approval, and 76% of those reached), and 276 were eligible. Sixteen percent of all active patients refused participation, and 8% of contacted patients were unreachable. Two hundred fifty-two patients were randomized after completion of baseline assessments. Clinical, behavioral, and psychosocial assessment completion rates were 92%, 77%, and 86% at 12-month follow-up, respectively, and 93% of patients completed at least one study assessment at 12 months. CHCs are a prime setting for translation research aimed to eliminate diabetes health disparities. Successful recruitment and retention efforts must address institutional/organizational, research team, and patient-related challenges.
Adam, Laura M; Manca, Donna P; Bell, Rhonda C
Background Recruitment is often a difficult and costly part of any human research study. Social media and other emerging means of mass communication hold promise as means to complement traditional strategies used for recruiting participants because they can reach a large number of people in a short amount of time. With the ability to target a specified audience, paid Facebook advertisements have potential to reach future research participants of a specific demographic. This paper describes th...
Full Text Available Abstract Background Participants in trials evaluating preventive interventions such as screening are on average healthier than the general population. To decrease this 'healthy volunteer effect' (HVE women were randomly invited from population registers to participate in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS and not allowed to self refer. This report assesses the extent of the HVE still prevalent in UKCTOCS and considers how certain shortfalls in mortality and incidence can be related to differences in socioeconomic status. Methods Between 2001 and 2005, 202 638 postmenopausal women joined the trial out of 1 243 312 women randomly invited from local health authority registers. The cohort was flagged for deaths and cancer registrations and mean follow up at censoring was 5.55 years for mortality, and 2.58 years for cancer incidence. Overall and cause-specific Standardised Mortality Ratios (SMRs and Standardised Incidence Ratios (SIRs were calculated based on national mortality (2005 and cancer incidence (2006 statistics. The Index of Multiple Deprivation (IMD 2007 was used to assess the link between socioeconomic status and mortality/cancer incidence, and differences between the invited and recruited populations. Results The SMR for all trial participants was 37%. By subgroup, the SMRs were higher for: younger age groups, extremes of BMI distribution and with each increasing year in trial. There was a clear trend between lower socioeconomic status and increased mortality but less pronounced with incidence. While the invited population had higher mean IMD scores (more deprived than the national average, those who joined the trial were less deprived. Conclusions Recruitment to screening trials through invitation from population registers does not prevent a pronounced HVE on mortality. The impact on cancer incidence is much smaller. Similar shortfalls can be expected in other screening RCTs and it maybe prudent
Kohrt, Brandon A; Yang, Minyoung; Rai, Sauharda; Bhardwaj, Anvita; Tol, Wietse A; Jordans, Mark J D
Preventing involuntary conscription and voluntary recruitment of youth into armed groups are global human rights priorities. Pathways for self-reported voluntary recruitment and the impact of voluntary recruitment on mental health have received limited attention. The objective of this study was to identify risk factors for voluntarily joining armed groups, as well as the association of conscription status and mental health. In Nepal, interviews were conducted with 258 former child soldiers who participated in a communist (Maoist) revolution. Eighty percent of child soldiers joined 'voluntarily'. Girls were 2.07 times as likely to join voluntarily (95% CI, 1.03-4.16, p=0.04). Among girls, 51% reported joining voluntarily because of personal connections to people who were members of the armed group, compared to 22% of boys. Other reasons included escaping difficult life situations (36%), inability to achieve other goals in life (28%), and an appealing philosophy of the armed group (32%). Poor economic conditions were more frequently endorsed among boys (22%) than girls (10%). Voluntary conscription was associated with decreased risk for PTSD among boys but not for girls. Interventions to prevent voluntary association with armed groups could benefit from attending to difficulties in daily life, identifying non-violent paths to achieve life goals, and challenging the political philosophy of armed groups. Among boys, addressing economic risk factors may prevent recruitment, and prevention efforts for girls will need to address personal connections to armed groups, as it has important implications for preventing recruitment through new methods, such as social media.
Nicholas, Angela; Bailey, Julia V; Stevenson, Fiona; Murray, Elizabeth
Incidence of sexually transmitted infections (STIs) among young people in the United Kingdom is increasing. The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion, given its high usage among young people, its potential for creating a sense of anonymity, and ease of access. Online randomized controlled trials (RCTs) are increasingly being used to evaluate online interventions, but while there are many advantages to online methodologies, they can be associated with a number of problems, including poor engagement with online interventions, poor trial retention, and concerns about the validity of data collected through self-report online. We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website. This study reports on a qualitative evaluation of the trial procedures, describing participants' experiences and views of the Sexunzipped online trial including methods of recruitment, incentives, methods of contact, and sexual health outcome measurement. Our goal was to determine participants' views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention. We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology: (1) individual interviews with 22 participants from the pilot RCT, (2) 133 emails received by the trial coordinator from trial participants, and (3) 217 free-text comments from the baseline and follow-up questionnaires. Interviews were audio-recorded and transcribed verbatim. An iterative, thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology. Interview participants found the trial design, including online recruitment via Facebook, online registration, email communication with the researchers, and
The impact of widening participation policy and how it is enacted institutionally is a central concern to Higher Education. It is not simply about the admission of students from disadvantaged backgrounds, but also ensuring that these students complete their courses successfully. This work therefore goes far beyond those departments tasked with…
Goff, Sarah L; Youssef, Yara; Pekow, Penelope S; White, Katharine O; Guhn-Knight, Haley; Lagu, Tara; Mazor, Kathleen M; Lindenauer, Peter K
Racial/ethnic minority patients are often underrepresented in clinical trials. Efforts to address barriers to participation may improve representation, thus enhancing our understanding of how research findings apply to more diverse populations. The IDEAS (Information, Description, Education, Assistance, and Support) for a Healthy Baby study was a randomized controlled trial (RCT) of an intervention to reduce barriers to using publicly reported quality data for low-income, racial/ethnic minority women. We used strategies grounded in a health equity framework to address barriers to recruitment and retention in three domains: preparation, process, and patient-centeredness. "Preparation" included teaching study staff about health inequities, role-playing skills to develop rapport and trust, and partnering with clinic staff. "Processes" included use of electronic registration systems to pre-screen potential candidates and determine when eligible participants were in clinic and an electronic database to track patients through the study. Use of a flexible protocol, stipends, and consideration of literacy levels promoted "patient-centeredness." We anticipated needing to recruit 800 women over 18 months to achieve a completion goal of 650. Using the recruitment and retention strategies outlined above, we recruited 746 women in 15 months, achieving higher recruitment (87.1 %) and retention rates (97.3 %) than we had anticipated. These successful recruitment and retention strategies used for a large RCT promoted inclusivity and accessibility. Researchers seeking to recruit racial and ethnic minority pregnant women in similar settings may find the preparation, process, and patient-centered strategies used in this study applicable for their own studies. ClinicalTrials.gov NCT01784575 , 1R21HS021864-01.
Laws, Rachel A; Fanaian, Mahnaz; Jayasinghe, Upali W; McKenzie, Suzanne; Passey, Megan; Davies, Gawaine Powell; Lyle, David; Harris, Mark F
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
Mucka, Lilia E; Dayton, Carolyn J; Lawler, Jamie; Kirk, Rosalind; Alfafara, Emily; Schuster, Melisa M; Miller, Nicole; Ribaudo, Julie; Rosenblum, Katherine Lisa; Muzik, Maria
Parenting group success begins with attendance. Using archival pilot data from 99 mothers who enrolled in the Mom Power (MP) parenting intervention, this study sought to understand the factors that influenced participant engagement and retention. MP is a group-based, early intervention program grounded in attachment theory that utilizes motivational interviewing as a core component to enhance program engagement. Study aims were to qualitatively describe the reasons why mothers were interested in participating in the program, including what they hoped to gain from the experience, and to quantitatively examine the extent to which attendance was associated with demographic, experiential, and psychosocial factors. The qualitative analysis of intake interviews revealed that mothers expected the MP intervention to provide a warm environment for themselves and their children as well as to support and enhance their parenting, and 95% revealed their hopes that the intervention would help them grow and develop as women. Attendance rates were relatively high, with 62% of mothers missing less than one group session. Quantitative analyses using multiple regression to test associations of demographic, experiential, and psychosocial factors with attendance rates were not significant. Results suggest that motivational interviewing may be an important component in promoting participant engagement efforts in parenting interventions. © 2017 Michigan Association for Infant Mental Health.
Hugelius, Karin; Adolfsson, Annsofie; Gifford, Mervyn; Örtenwall, Per
Disaster research entails several methodological challenges, given the context of a disaster. This article aims to describe and evaluate the use of Facebook as a tool to recruit participants for a self-selected Internet sample using a web-based survey in a post-disaster setting in the Philippines after the Haiyan typhoon hit parts of the country in November 2013. An invitation to a web-based survey about health was posted on several Facebook pages during a ten-day period. In total, 443 individuals who had survived the Haiyan typhoon participated in the study. The demographics of the study sample were similar to the general demographics in the Philippines, considering gender, age distribution and level of education. The study showed that the use of social media to recruit participants for disaster research could limit several of the practical and ethical challenges connected to disaster research. However, the method demands access to the Internet and requires several strategic considerations, particularly concerning non-probability sample biases and generalization as well as an active approach from the researcher.
Fazzino, Tera L; Rose, Gail L; Pollack, Scott M; Helzer, John E
Recruiting young adults for health research is challenging. Social media provides wide access to potential research participants. We evaluated the feasibility of recruiting students via free message postings on Facebook and Twitter to participate in a web-based brief intervention study. The sample comprised students attending U.S. and Canadian universities. During three semesters, institutional review board-approved recruitment messages were posted in 281 Facebook groups, 7 Facebook pages, and 27 message "tweets" on Twitter. A total of 708 eligible participants were recruited from Facebook. The mean enrollment rate per Facebook group was 0.21%; the rate was higher for host university groups (1.56%) compared with groups at other universities (0.10%). We recruited seven participants from Twitter. The sample was predominantly female (70%) with a mean age of 20.0 years. There were no significant differences between host university participants recruited through social media and traditional methods. The web-based intervention completion rate was 65%, and participants from the host university were more likely to complete the intervention than were groups at other universities (p = .01). Social media provides access to a large number of potential participants, and social media recruitment may be useful to researchers who can harness this broad reach. Facebook recruitment was feasible and free and resulted in a large number of enrolled participants. Social media recruitment for researchers at their own universities may be particularly fruitful. Despite wide access to students with Twitter, recruitment was slow. Social media recruitment allowed us to extend web-based intervention access to students in the United States and Canada.
Schuck, K.; Bricker, J.B.; Otten, R.; Kleinjan, M.; Brandon, T.H.; Engels, R.C.M.E.
Aims To test the effectiveness of tailored quitline (telephone) counselling among smoking parents recruited into cessation support through their children's primary schools. Design Two-arm randomized controlled trial with 3- and 12-month follow-up. Setting Proactive telephone counselling was
Ejiogu, Ngozi; Norbeck, Jennifer H; Mason, Marc A; Cromwell, Bridget C; Zonderman, Alan B; Evans, Michele K
Investigating health disparities requires studies designed to recruit and retain racially and socioeconomically diverse cohorts. It is critical to address the barriers that disproportionately affect participation in clinical research by minorities and the socioeconomically disadvantaged. This study sought to identify and rectify these barriers to recruit and retain a biracial (African American and non-Hispanic White) and socioeconomically diverse cohort for a longitudinal study. The Healthy Aging in Neighborhoods of Diversity across the Life Span study is a 20-year longitudinal examination of how race and socioeconomic status influence the development of age-related health disparities. One goal was to create a multifactorial recruitment and retention strategy. The recruitment paradigm targeted known barriers and identified those unique to the study's urban environment. The retention paradigm mirrored the recruitment plan but was based on specifically developed approaches. This cohort recruitment required attention to developing community partnerships, designing the research study to meet the study hypotheses and to provide benefit to participants, providing a safe community-based site for the research and creating didactics to develop staff cultural proficiency. These efforts facilitated study implementation and enhanced recruitment resulting in accrual of a biracial and socioeconomically diverse cohort of 3,722 participants. Recruiting and retaining minority or poor research participants is challenging but possible. The essential facets include clear communication of the research hypothesis, focus on providing a direct benefit for participants, and selection of a hypothesis that is directly relevant to the community studied.
Landers, Margaret; McCarthy, Geraldine; Savage, Eileen
Aim: The purpose of this paper is to present some of the challenges found to be problematic in recruiting individuals following sphincter saving surgery for rectal cancer for a multicentre study. While the focus of the study is on symptom experiences and management of bowel symptoms following colo-rectal surgery, the paper will concentrate solely on the challenges experienced in recruiting a sample for the study. Background Recruitment of an adequate number of participants is a challenge for ...
Friedman, Daniela B; Foster, Caroline; Bergeron, Caroline D; Tanner, Andrea; Kim, Sei-Hill
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.
Leavitt, Leah; Abroms, Lorien; Johnson, Pamela; Schindler-Ruwisch, Jennifer; Bushar, Jessica; Singh, Indira; Cleary, Sean D; McInvale, Whitney; Turner, Monique
Recruiting pregnant smokers into clinical trials is challenging since this population tends to be disadvantaged, the behavior is stigmatized, and the intervention window is limited. The purpose of this study is to test the feasibility and effectiveness of recruiting pregnant smokers into a smoking cessation trial by sending recruitment text messages to an existing subscriber list. Recruitment messages were sent to subscribers flagged as pregnant in Text4baby, a national text messaging program for pregnant women and mothers. Four recruitment messages were rotated to test the effectiveness of different emotional frames and a financial incentive. Study staff called subscribers who expressed interest to screen for eligibility and enroll eligible women. Between October 6, 2015 and February 2, 2016, 10,194 recruitment messages were sent to Text4baby subscribers flagged as pregnant, and 10.18% (1038) responded indicating interest. No significant increase in cancellation was observed compared to subscribers who received other ad hoc messages. Of respondents, 54.05% (561) were reached by phone for follow-up, and 21.97% (228) were found to be eligible. Among the eligible, 87% (199) pregnant smokers enrolled. The recruitment message with a pride emotional appeal had a significantly higher response (p = 0.02) compared to the recruitment message with no emotional appeal, but enrollment did not significantly differ between recruitment messages with different emotional appeals. The recruitment messages with a reference to financial incentive yielded higher response (p message without. This study demonstrates success recruiting pregnant smokers using text message. Future studies should consider building on this approach for recruiting high-risk populations.
Heijmans, N.; Lieshout, J. van; Wensing, M.J.
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
The habitat use by nearly 3 000 reef fish recruits, comprising 56 taxa, at seven sites in Mafia Island Marine Park, Tanzania, were examined. The study was carried out following the 1998 global coral bleaching event and all sites but one were dominated by dead coral and rubble. Mean recruit densities ranged between 0.1 ...
Reips, Ulf-Dietrich; Lengler, Ralph
The Web Experiment List (http://genpsylab-wexlist.unizh.ch/), a free Web-based service for the recruitment of participants in Internet-based experiments, is presented. The Web Experiment List also serves as a searchable archive for the research community. It lists more than 250 links to and descriptions of current and past Web experiments. Searches can be conducted by area of research, language, type of study, date, and status (active vs. archived). Data from log file analyses reveal an increasing use of the Web Experiment List and provide a picture of the distribution of the use of the Web experiment method across disciplines. On a general theoretical note, Web services are discussed as a viable software alternative to the traditional program format.
Qadri, Syed M; Su, Yang; Cayabyab, Francisco S; Liu, Lixin
Excessive levels of methylglyoxal (MG) encountered in diabetes foster enhanced leukocyte-endothelial cell interactions, mechanisms of which are incompletely understood. MG genomically upregulates endothelial serum- and glucocorticoid-inducible kinase 1 (SGK1) which orchestrates leukocyte recruitment by regulating the activation and expression of transcription factors and adhesion molecules. SGK1 regulates a myriad of ion channels and carriers including the Na+/H+ exchanger NHE1. Here, we explored the effect of MG on SGK1-dependent NHE1 activation and the putative role of NHE1 activation in MG-induced leukocyte recruitment and microvascular hyperpermeability. Using RT-PCR and immunoblotting, we analyzed NHE1 mRNA and protein levels in murine microvascular SVEC4-10EE2 endothelial cells (EE2 ECs). NHE1 phosphorylation was detected using a specific antibody against the 14-3-3 binding motif at phospho-Ser703. SGK in EE2 ECs was silenced using targeted siRNA. ROS production was determined using DCF-dependent fluorescence. Leukocyte recruitment and microvascular permeability in murine cremasteric microvasculature were measured using intravital microscopy. The expression of endothelial adhesion molecules was determined by immunoblotting and confocal imaging analysis. MG treatment significantly upregulated NHE1 mRNA and dose-dependently increased total- and phospho-NHE1. Treatment with SGK1 inhibitor GSK650394, antioxidant Tempol and silencing SGK all blunted MG-triggered phospho-NHE1 upregulation in EE2 ECs. NHE1 inhibitor cariporide attenuated MG-triggered ROS production, leukocyte adhesion and emigration and microvascular hyperpermeability, without affecting leukocyte rolling. Cariporide treatment did not alter MG-triggered upregulation of P- and E-selectins, but reduced endothelial ICAM-1 expression. MG elicits SGK1-dependent activation of endothelial Na+/H+ exchanger NHE1 which participates in MG-induced ROS production, upregulation of endothelial ICAM-1, leukocyte
Conclusion: Analysis of the 2 randomized controlled trials has provided valuable insights into the recruitment process and identified resources that can help better planning and recruitment for future interventions. Recommendations aimed at increasing the success of future recruitment efforts are provided.
Full Text Available Dolores P Langford,1,2 Lena Fleig,3–5 Kristin C Brown,3,4 Nancy J Cho,1,2 Maeve Frost,1 Monique Ledoyen,1 Jayne Lehn,1 Kostas Panagiotopoulos,1,6 Nina Sharpe,1 Maureen C Ashe3,4 1Vancouver Coastal Health, 2Department of Physical Therapy, The University of British Columbia (UBC, 3Department of Family Practice, The University of British Columbia (UBC, 4Centre for Hip Health and Mobility, Vancouver, BC, Canada; 5Freie Universität Berlin, Health Psychology, Berlin, Germany; 6Department of Orthopaedics, The University of British Columbia (UBC, Vancouver, BC, Canada Objectives: Our primary aim of this pilot study was to test feasibility of the planned design, the interventions (education plus telephone coaching, and the outcome measures, and to facilitate a power calculation for a future randomized controlled trial to improve adherence to recovery goals following hip fracture.Design: This is a parallel 1:1 randomized controlled feasibility study.Setting: The study was conducted in a teaching hospital in Vancouver, BC, Canada.Participants: Participants were community-dwelling adults over 60 years of age with a recent hip fracture. They were recruited and assessed in hospital, and then randomized after hospital discharge to the intervention or control group by a web-based randomization service. Treatment allocation was concealed to the investigators, measurement team, and data entry assistants and analysts. Participants and the research physiotherapist were aware of treatment allocation.Intervention: Intervention included usual care for hip fracture plus a 1-hour in-hospital educational session using a patient-centered educational manual and four videos, and up to five postdischarge telephone calls from a physiotherapist to provide recovery coaching. The control group received usual care plus a 1-hour in-hospital educational session using the educational manual and videos.Measurement: Our primary outcome was feasibility, specifically recruitment
Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N
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.
Bonacho dos Anjos Henriques-Cadby, Inês; Bortolami, Oscar; Flight, Laura; Hind, Daniel; Knox, Christopher; Nadin, Ben; Rothwell, Joanne; Surtees, Michael; Julious, Steven A
Background Substantial amounts of public funds are invested in health research worldwide. Publicly funded randomised controlled trials (RCTs) often recruit participants at a slower than anticipated rate. Many trials fail to reach their planned sample size within the envisaged trial timescale and trial funding envelope. Objectives To review the consent, recruitment and retention rates for single and multicentre randomised control trials funded and published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme. Data sources and study selection HTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed. Data extraction Information was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers. Main outcome measures Target sample size and whether it was achieved; recruitment rates (number of participants recruited per centre per month) and retention rates (randomised participants retained and assessed with valid primary outcome data). Results This review identified 151 individually RCTs from 787 NIHR HTA reports. The final recruitment target sample size was achieved in 56% (85/151) of the RCTs and more than 80% of the final target sample size was achieved for 79% of the RCTs (119/151). The median recruitment rate (participants per centre per month) was found to be 0.92 (IQR 0.43–2.79) and the median retention rate (proportion of participants with valid primary outcome data at follow-up) was estimated at 89% (IQR 79–97%). Conclusions There is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections. PMID:28320800
Walters, Stephen J; Bonacho Dos Anjos Henriques-Cadby, Inês; Bortolami, Oscar; Flight, Laura; Hind, Daniel; Jacques, Richard M; Knox, Christopher; Nadin, Ben; Rothwell, Joanne; Surtees, Michael; Julious, Steven A
Substantial amounts of public funds are invested in health research worldwide. Publicly funded randomised controlled trials (RCTs) often recruit participants at a slower than anticipated rate. Many trials fail to reach their planned sample size within the envisaged trial timescale and trial funding envelope. To review the consent, recruitment and retention rates for single and multicentre randomised control trials funded and published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme. HTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed. Information was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers. Target sample size and whether it was achieved; recruitment rates (number of participants recruited per centre per month) and retention rates (randomised participants retained and assessed with valid primary outcome data). This review identified 151 individually RCTs from 787 NIHR HTA reports. The final recruitment target sample size was achieved in 56% (85/151) of the RCTs and more than 80% of the final target sample size was achieved for 79% of the RCTs (119/151). The median recruitment rate (participants per centre per month) was found to be 0.92 (IQR 0.43-2.79) and the median retention rate (proportion of participants with valid primary outcome data at follow-up) was estimated at 89% (IQR 79-97%). There is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections. 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/.
Merchant, Roland C; Romanoff, Justin; Clark, Melissa A; Liu, Tao; Rosenberger, Joshua G; Bauermeister, Jose; Mayer, Kenneth H
The Internet is a commonly used medium for recruiting geographically dispersed, smaller populations quickly, such as young adult men-who-have-sex-with-men (YMSM). One approach to improve reach and representativeness is to employ multiple Internet platforms to recruit this hard-to-reach population. The utility of this approach has not been studied adequately, and its impact on the study sample recruited is not yet known. Using data from a study of 18- to 24-year-old HIV-uninfected, Black, Hispanic, and White United States (US) YMSM, this investigation compared advertising and enrollment metrics and participant characteristics of those recruited across Internet platforms. Of the 2,444 participants, their median age was 22 years old; 21% were Black, 37% Hispanic, and 42% White; 90% had been tested for HIV at least once in their life; and 87% reported prior condomless anal intercourse (CAI) with another man. There were noticeable differences across platforms in the number of people accessing the study website, meeting study eligibility requirements, consenting to participate, consenting to participate per day of advertising and per click, as well as costs of advertising per consented participant. Participants recruited also varied across platform by race/ethnicity, geographic area of residence in the US, health-care insurance status, years of formal education, history of HIV testing, and CAI by partner type and sexual positioning. The investigation results indicate that the Internet platforms used for recruitment significantly impact not only enrollment but also diversity and characteristics of the sample obtained and consequently, the observations and conclusions rendered.
Jones, Ray B; Goldsmith, Lesley; Williams, Christopher J; Kamel Boulos, Maged N
Google AdWords are increasingly used to recruit people into research studies and clinical services. They offer the potential to recruit from targeted control areas in cluster randomized controlled trials (RCTs), but little is known about the feasibility of accurately targeting ads by location and comparing with control areas. To examine the accuracy and contamination of control areas by a location-targeted online intervention using Google AdWords in a pilot cluster RCT. Based on previous use of online cognitive behavioral therapy for depression and population size, we purposively selected 16 of the 121 British postcode areas and randomized them to three intervention and one (do-nothing) control arms. Two intervention arms included use of location-targeted AdWords, and we compared these with the do-nothing control arm. We did not raise the visibility of our research website to normal Web searches. Users who clicked on the ad were directed to our project website, which collected the computer Internet protocol (IP) address, date, and time. Visitors were asked for their postcode area and to complete the Patient Health Questionnaire (depression). They were then offered links to several online depression resources. Google Analytics largely uses IP methods to estimate location, but AdWords uses additional information. We compared locations assessed by (1) Analytics, and (2) as self-identified by users. Ads were shown 300,523 times with 4207 click-throughs. There were few site visits except through AdWord click-throughs. Both methods of location assessment agreed there was little contamination of control areas. According to Analytics, 69.75% (2617/3752) of participants were in intervention areas, only 0% (8/3752) in control areas, but 30.04% (1127/3752) in other areas. However, according to user-stated postcodes, only 20.7% (463/2237) were in intervention areas, 1% (22/2236) in control areas, but 78.31% (1751/2236) in other areas. Both location assessments suggested most
Brandon A. Kohrt; Yang, Minyoung; Rai, Sauharda; Bhardwaj, Anvita; Tol, Wietse A.; Jordans, Mark J. D.
Preventing involuntary conscription and voluntary recruitment of youth into armed groups are global human rights priorities. Pathways for self-reported voluntary recruitment and the impact of voluntary recruitment on mental health have received limited attention. The objective of this study was to identify risk factors for voluntarily joining armed groups, as well as the association of conscription status and mental health. In Nepal, interviews were conducted with 258 former child soldiers wh...
Baikie, Karen A; Geerligs, Liesbeth; Wilhelm, Kay
Expressive writing--writing about traumatic, stressful or emotional events--often leads to improvements in physical and psychological health in non-clinical and clinical populations. Recent studies have shown that positive writing may also be beneficial. Research has not yet investigated whether either expressive writing or positive writing offers benefits for people with mood disorders. Participants were recruited online and were randomly allocated to expressive writing, positive writing or control writing. The following questionnaires were completed online: Centre for Epidemiological Studies-Depression Scale (CES-D), Depression Anxiety Stress Scales (DASS), Pennebaker Inventory of Limbic Languidness (PILL), overall health questions, Temperament and Personality Questionnaire (TPQ) and COPE Inventory (COPE). Participants then wrote for 20 min on 4 occasions, and then completed follow-up questionnaires. Linear mixed models with custom contrasts were conducted to assess differences between groups and over time. All 3 groups showed significant improvements over time on mental health and some physical health outcomes. There were no significant differences between groups and no significant group by time interactions. These results were not moderated by demographic factors, personality subtypes or coping styles. The expressive writing, positive writing and time management control writing groups all reported significantly fewer mental and physical symptoms for at least 4 months post-writing. When expressive and positive writing groups were combined, the resulting `emotional writing group' showed significantly lower scores on the DASS stress subscale than the control writing group at all time-points. Potential reasons are discussed and areas of further study identified. Copyright © 2011 Elsevier B.V. All rights reserved.
Petosa, R L; Smith, L
In school settings, nurses lead efforts to improve the student health and well-being to support academic success. Nurses are guided by evidenced-based practice and data to inform care decisions. The randomized controlled trial (RCT) is considered the gold standard of scientific rigor for clinical trials. RCTs are critical to the development of evidence-based health promotion programs in schools. The purpose of this article is to present practical solutions to implementing principles of randomization to RCT trials conducted in school settings. Randomization is a powerful sampling method used to build internal and external validity. The school's daily organization and educational mission provide several barriers to randomization. Based on the authors' experience in conducting school-based RCTs, they offer a host of practical solutions to working with schools to successfully implement randomization procedures. Nurses play a critical role in implementing RCTs in schools to promote rigorous science in support of evidence-based practice.
Stratton, Shawna L.; Spencer, Horace J.; Greenfield, William W.; Low, Gordon; Hitt, W. Chuck; Quick, Charles M.; Jeffus, Susanne K.; Blackmon, Victoria; Nakagawa, Mayumi
Background Historically, recruitment and retention of young women in intervention-based clinical trials has been challenging. In August 2012, enrollment for a clinical trial testing of an investigational human papillomavirus (HPV) 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 Papanicolau smear results showing high-grade squamous intraepithelial lesions (HSILs) or cannot rule out HSIL were eligible to enroll. Patients with biopsy-confirmed HSIL were also eligible. Colposopy was performed at the screening visit, and participants became eligible for vaccination when the diagnosis of HSIL was confirmed with biopsy and other inclusion criteria were met. Purpose The aim of this study was to identify strategies and factors effective in recruitment and retention of study participants. Methods Potential vaccine candidates were recruited through direct advertisement as well as referrals, including 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 identifying factor(s) associated with recruitment and retention. Results Thirty-seven participants were
Choi, Won S; Nazir, Niaman; Pacheco, Christina M; Filippi, Melissa K; Pacheco, Joseph; White Bull, Julia; Nance, Christi; Faseru, Babalola; Greiner, K Allen; Daley, Christine Makosky
American Indians (AIs) have the highest cigarette smoking rates of any racial/ethnic group in the United States. Although the overall smoking prevalence in the United States for nonminority populations has decreased over the past several decades, the same pattern is not observed among AIs. The purpose of this observational study was to collect cigarette smoking and related information from American Indian tribal college students to inform tailored interventions. We conducted a repeated cross-sectional survey of American Indian tribal college students, Tribal College Tobacco and Behavior Survey (TCTABS), with a focus on recruiting all incoming freshman at three participating tribal colleges in the Midwest and Northern Plains regions. A total of 1256 students participated in the baseline surveys between April 2011 and October 2014. The overall smoking prevalence of this sample was 34.7%, with differences by region (Northern Plains-44.0% and Midwest-28%). The majority, 87.5% of current smokers reported smoking 10 or less cigarettes per day, 41% reported smoking menthol cigarettes, 52% smoked Marlboro brand, and the mean age of their first cigarette was 14 years. The majority, 62% had made at least one quit attempt in the past year. The overwhelming majority of respondents, regardless of their smoking status, thought that the current smoking prevalence on campus was greater than 41% and approximately one-third believed that it was as high as 61%. Very few studies of smoking have been conducted in this population and results from our study confirm the need for effective interventions. AIs have the highest cigarette smoking rates compared to other racial/ethnic groups in the United States. Furthermore, limited studies have examined the epidemiology of cigarette smoking among tribal college students. This study addresses health disparities related to smoking among college students by examining the demographic, cultural, and environmental characteristics of smoking and
Starks, Helene; Doorenbos, Ardith; Lindhorst, Taryn; Bourget, Erica; Aisenberg, Eugene; Oman, Natalie; Rue, Tessa; Curtis, J Randall; Hays, Ross
To describe the study methods, baseline characteristics and burden of study procedures of an intervention designed to reduce family stress symptoms through early support from the palliative care team. Length of stay of ≥8days was the trigger for early palliative care involvement. Cluster-randomized trial with children as the unit of randomization. Up to 3 family members per child were recruited. Family stress symptoms were recorded at baseline, discharge from the ICU, and 3months post-enrollment. Questionnaire burden was assessed on a 1-10 point scale at each time point and open-ended comments were analyzed to describe the participants' experience in the study. 380 family members of 220 children (control=115 children and 204 family members; intervention=105 children and 176 family members) were recruited, which represented 50% of all eligible families. Most family participants were parents (86% control; 92% intervention) and female (66% both groups). Retention rates were high through the 3-month follow-up: 93% and 90% for the control and intervention groups respectively. Questionnaire burden was very low: mean (sd) scores were 1.1 (1.6), 0.7 (1.5), and 0.9 (1.6) for the baseline, discharge and follow-up questionnaires, respectively. Comments suggest that participation was beneficial by promoting reflection and self-awareness about stress, coping and resilience, and feeling cared for because the intervention and questionnaires focused on their own well-being. The participants' comments regarding the focus on them as the point of intervention reflects the value of conducting research with family members of seriously ill children during ICU stays. Copyright © 2016 Elsevier Inc. All rights reserved.
Oude Voshaar, R.C.; Gorgels, W.J.M.J.; Mol, A.J.J.; Balkom, A.J.L.M. van; Mulder, J.; Lisdonk, E.H. van de; Breteler, M.H.M.; Zitman, F.G.
OBJECTIVE: To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. METHOD: We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in
Bennett Ian M
Full Text Available Abstract Background Recruitment and retention of patients for randomized control trial (RCT studies can provide formidable challenges, particularly with minority and underserved populations. Data are reported for the Philadelphia Collaborative Preterm Prevention Project (PCPPP, a large RCT targeting risk factors for repeat preterm births among women who previously delivered premature ( Methods Design of the PCPPP incorporated strategies to maximize recruitment and retention. These included an advanced database system tracking follow-up status and assessment completion rates; cultural sensitivity training for staff; communication to the community and eligible women of the benefits of participation; financial incentives; assistance with transportation and supervised childcare services; and reminder calls for convenient, flexibly scheduled appointments. Analyses reported here: 1 compare recruitment projections to actual enrollment 2 explore recruitment bias; 3 validate the randomization process 4 document the extent to which contact was maintained and complete assessments achieved 5 determine if follow-up was conditioned upon socio-economic status, race/ethnicity, or other factors. Results Of eligible women approached, 1,126 (77.7% agreed to participate fully. Of the 324 not agreeing, 118 (36.4% completed a short survey. Consenting women were disproportionately from minority and low SES backgrounds: 71.5% consenting were African American, versus 38.8% not consenting. Consenting women were also more likely to report homelessness during their lifetime (14.6% vs. 0.87% and to be unmarried at the time of delivery (81.6% versus 47.9%. First one-month postpartum assessment was completed for 83.5% (n = 472 of the intervention group (n = 565 and 76% (426 of the control group. Higher assessment completion rates were observed for the intervention group throughout the follow-up. Second, third, fourth and fifth postpartum assessments were 67.6% vs. 57.5%, 60
Cambron, Jerrilyn A; Dexheimer, Jennifer M; Chang, Mabel; Cramer, Gregory D
The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis. This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives. Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization). Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.
Langeheine, Malte; Pohlabeln, Hermann; Ahrens, Wolfgang; Rach, Stefan
Declining response proportions in population-based studies are often countered by extended recruitment efforts at baseline that may, however, result in higher attrition in a subsequent follow-up. This study analysed the effect of extended recruitment efforts on attrition at the first follow-up of a child cohort. We used paradata (i.e. information about the process of data collection) from the German IDEFICS cohort investigating dietary- and life style-induced health effects on children to quantify recruitment effort and classify respondents as completing the recruitment early vs. late for baseline and follow-up separately. Multilevel logistic regression models were used to investigate the association between recruitment effort and attrition at follow-up (loss to follow-up) adjusted for sociodemographic and health related variables. Individuals who were late respondents at baseline and early respondents at the follow-up had a higher chance of attrition (odds ratio 1.65, 95% confidence interval (CI) 1.19, 2.28) as compared to other groups. An investigation of reasons for non-participation revealed that members of this group were more likely to be not reachable by phone. An extended recruitment effort at baseline of a child cohort study is not per se associated with a higher chance of attrition at follow-up. Much care should be taken to collect valid telephone numbers. © 2016 John Wiley & Sons Ltd.
Full Text Available A substantial challenge facing multicentre audit and research projects is timely recruitment of collaborators and their study centres. Cost-effective strategies are required and fee-free social media has previously been identified as a potential conduit. We investigated and evaluated the effectiveness of a novel multi-format social media and Internet strategy for targeted recruitment to a national multicentre cohort study.Interventions involved a new Twitter account, including weekly live question-and-answer sessions, a new Facebook group page, online YouTube presentations and an information page on a national association website. Link tracking analysis was undertaken using Google Analytics, which was then related to subsequent registration. Social influence was calculated using the proprietary Klout score.Internet traffic analysis identified a total of 1562 unique registration site views, of which 285 originated from social media (18.2%. Some 528 unique registrations were received, with 96 via social media platforms (18.2%. Traffic source analysis identified a separate national association webpage as resulting in the majority of registration page views (15.8%, followed by Facebook (11.9%, Twitter (4.8% and YouTube (1.5%. A combination of publicity through Facebook, Twitter and the dedicated national association webpage contributed to the greatest rise in registration traffic and accounted for 312 (48% of the total registrations within a 2-week period. A Twitter 'social influence' (Klout score of 42/100 was obtained during this period.Targeted social media substantially aided study dissemination and collaborator recruitment. It acted as an adjunct to traditional methods, accounting for 18.2% of collaborator registration in a short time period with no associated financial costs. We provide a practical model for designing future recruitment campaigns, and recommend Facebook, Twitter and targeted websites as the most effective adjuncts for
Khatri, Chetan; Chapman, Stephen J; Glasbey, James; Kelly, Michael; Nepogodiev, Dmitri; Bhangu, Aneel; Fitzgerald, J Edward
A substantial challenge facing multicentre audit and research projects is timely recruitment of collaborators and their study centres. Cost-effective strategies are required and fee-free social media has previously been identified as a potential conduit. We investigated and evaluated the effectiveness of a novel multi-format social media and Internet strategy for targeted recruitment to a national multicentre cohort study. Interventions involved a new Twitter account, including weekly live question-and-answer sessions, a new Facebook group page, online YouTube presentations and an information page on a national association website. Link tracking analysis was undertaken using Google Analytics, which was then related to subsequent registration. Social influence was calculated using the proprietary Klout score. Internet traffic analysis identified a total of 1562 unique registration site views, of which 285 originated from social media (18.2%). Some 528 unique registrations were received, with 96 via social media platforms (18.2%). Traffic source analysis identified a separate national association webpage as resulting in the majority of registration page views (15.8%), followed by Facebook (11.9%), Twitter (4.8%) and YouTube (1.5%). A combination of publicity through Facebook, Twitter and the dedicated national association webpage contributed to the greatest rise in registration traffic and accounted for 312 (48%) of the total registrations within a 2-week period. A Twitter 'social influence' (Klout) score of 42/100 was obtained during this period. Targeted social media substantially aided study dissemination and collaborator recruitment. It acted as an adjunct to traditional methods, accounting for 18.2% of collaborator registration in a short time period with no associated financial costs. We provide a practical model for designing future recruitment campaigns, and recommend Facebook, Twitter and targeted websites as the most effective adjuncts for maximising cost
Jason W Osborne
Full Text Available Research in the social sciences often relies upon the motivation and goodwill of research participants (e.g., teachers, students, minimally-compensated volunteers to do their best on low stakes assessments of the effects of interventions. Research participants who are unmotivated to perform well can engage in random responding on outcome measures, which can cause substantial mis-estimation of results, biasing results toward the null hypothesis. Data from a recent educational intervention study served as a clear example of this problem: participants identified as random responders showed substantially lower scores than other participants on tests during the study, and failed to show growth in scores from pre- to posttest, while those not engaging in random responding showed much higher scores and significant growth over time. This served to mask the hypothesized group differences across instructional method when random responders were retained in the sample (anticipated group differences were significant when these random responders were removed. We remind researchers to screen their data for random responding (and other response biases in their critical outcome measures in order to improve the odds of detecting effects of their interventions.
Aguiar, Elroy J; Morgan, Philip J; Collins, Clare E; Plotnikoff, Ronald C; Young, Myles D; Callister, Robin
Men are underrepresented in weight loss and type 2 diabetes mellitus (T2DM) prevention studies. To determine the effectiveness of recruitment, and acceptability of the T2DM Prevention Using LifeStyle Education (PULSE) Program-a gender-targeted, self-administered intervention for men. Men (18-65 years, high risk for T2DM) were randomized to intervention ( n = 53) or wait-list control groups ( n = 48). The 6-month PULSE Program intervention focused on weight loss, diet, and exercise for T2DM prevention. A process evaluation questionnaire was administered at 6 months to examine recruitment and selection processes, and acceptability of the intervention's delivery and content. Associations between self-monitoring and selected outcomes were assessed using Spearman's rank correlation. A pragmatic recruitment and online screening process was effective in identifying men at high risk of T2DM (prediabetes prevalence 70%). Men reported the trial was appealing because it targeted weight loss, T2DM prevention, and getting fit, and because it was perceived as "doable" and tailored for men. The intervention was considered acceptable, with men reporting high overall satisfaction (83%) and engagement with the various components. Adherence to self-monitoring was poor, with only 13% meeting requisite criteria. However, significant associations were observed between weekly self-monitoring of weight and change in weight ( rs = -.47, p = .004) and waist circumference ( rs = -.38, p = .026). Men reported they would have preferred more intervention contact, for example, by phone or email. Gender-targeted, self-administered lifestyle interventions are feasible, appealing, and satisfying for men. Future studies should explore the effects of additional non-face-to-face contact on motivation, accountability, self-monitoring adherence, and program efficacy.
Nguyen-Xuan, H-T; Thiollier, G; Ruault, O; Fauconnier, A; Lucot, J-P; Bader, G
Randomized controlled trials (RCT) in surgery are often subject to difficulties inherent in the study design and recruitment of patients. Women's participation rate to RCTs in surgery is relatively low and varies from 30 to 70%. These recruitment problems might induce a weak scientific value and even stop the study. Thus, optimizing recruitment is a challenge for surgical research. In contemporary literature, we lack data on motivations and profile of women who refuse to participate in a RCT in surgery. To explore the potentially influential factors affecting women's decision to decline participation in PROSPERE trial, comparing laparoscopic sacrocolpopexy (LSCP) to vaginal mesh for cystocele repair. Retrospective, observational, qualitative, bicentric study conducted in the department of gynecology of Poissy and Lille hospitals. Patients included were those who refused to participate to PROSPERE trial in both centers. Factors of non-participation in the trial were recorded at the time of the first visit. A control group consisted of women who agreed to participate in the trial was also analyzed. In both centers, 139 were eligible to participate in the trial but 35 of them (25%) refused. Thirty-two women agreed to declare their refusal motivations. Vaginal mesh was finally performed in 18 (56,2%) patients and LSCP in 14 patients (43,8%). The control group consisted of 20 women, including 9 operated by vaginal mesh and 11 by LSCP. Patient's characteristics were similar in the both groups. Most influencing factor in refusal for participation was "previous choice of technique" in 50% cases (16/32), followed by "geographical remoteness and difficulties for additional visits" in 40.6% cases (13/32), and finally by "do not accept the concept of randomization" in 21.8% cases (7/32). The most influencing factor in women's acceptance was interest in helping others by "supporting medical research" in 100% cases (20/20), followed by "potential personal benefits and close
Schuck, Kathrin; Bricker, Jonathan B; Otten, Roy; Kleinjan, Marloes; Brandon, Thomas H; Engels, Rutger C M E
To test the effectiveness of tailored quitline (telephone) counselling among smoking parents recruited into cessation support through their children's primary schools. Two-arm randomized controlled trial with 3- and 12-month follow-up. Proactive telephone counselling was administered by the Dutch national quitline. Smoking parents were recruited through their children's primary schools and received either intensive quitline support in combination with tailored supplementary materials (n = 256) or a standard self-help brochure (n = 256). The primary outcome was 7-day point-prevalence abstinence at 12-month follow-up. Also measured were baseline characteristics, use of and adherence to nicotine replacement therapy and pharmacotherapy, smoking characteristics and implementation of a home smoking ban. Parents who received quitline counselling were more likely to report 7-day point-prevalence abstinence at 12-month assessment [34.0 versus 18.0%, odds ratio (OR) = 2.35, confidence interval (CI) = 1.56-3.54] than those who received a standard self-help brochure. Parents who received quitline counselling were more likely to use nicotine replacement therapy (P help brochure. Among parents who did not achieve abstinence, those who received quitline counselling smoked fewer cigarettes at 3-month (P helping parents quit smoking and promoting parenting practices that protect their children from adverse effects of smoking. © 2014 Society for the Study of Addiction.
Damiani, Lucas Petri; Berwanger, Otavio; Paisani, Denise; Laranjeira, Ligia Nasi; Suzumura, Erica Aranha; Amato, Marcelo Britto Passos; Carvalho, Carlos Roberto Ribeiro; Cavalcanti, Alexandre Biasi
The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy). To describe the data management process and statistical analysis plan. The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes. According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results. ClinicalTrials.gov number, NCT01374022.
Nelson, Suchitra; Milgrom, Peter
To describe the strategies-based on the social triad concept of a partnership of researchers, school personnel and community-employed to recruit low-income, minority parent/caregivers of kindergarten children into a school-based tooth decay prevention trial in the United States. The study site was an urban school district with five elementary schools. Recruitment was carried out once each year for three years. Recruitment involved strategies at the school district, school, classroom, and student-parent level. A coalition of researchers, school personnel and community individuals was established for communication and recruitment. Outreach workers from the community were hired to promote, recruit, and disseminate oral health information. Study promotion included both print materials (logos, flyers, pictorial story boards) and presentations at school and community events. The School District Superintendent and administrators approved the study, and all five school principals and kindergarten teachers participated. All children within the classrooms were eligible: the overall participation rate of was 86% (580/672). Community outreach workers actively facilitated the recruitment and participants were recruited at open house for parent-teacher meeting (37% of all participants), sending letters and consent forms home (31%), at a prearranged convenient time during drop off and pick up of the child at their respective schools (30%), curriculum nights and health fairs (2%). Utilizing the social triad concept led to success in planning and carrying out the recruitment of predominantly minority school children with high participation rates. Copyright © 2011 Elsevier Inc. All rights reserved.
Stratton, Shawna L; Spencer, Horace J; Greenfield, William W; Low, Gordon; Hitt, Wilbur C; Quick, Charles M; Jeffus, Susanne K; Blackmon, Victoria; Nakagawa, Mayumi
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
Stiel, Stephanie; Heckel, Maria; Bussmann, Sonja; Weber, Martin; Ostgathe, Christoph
One essential element of research is the successful recruitment of participants. However, concerns are obvious regarding the ethical implications of involving terminally ill and even dying patients and their informal caregivers as research participants. This study aims to illustrate central issues encountered when recruiting bereaved informal caregivers for a questionnaire validation study on the quality of dying and death. Between July 2012 and November 2013, informal caregivers of deceased inpatients who were treated at two palliative care units in Germany were invited to participate in a questionnaire validation study. Informal caregivers were called by a trained researcher at the end of the fourth week after death at the earliest and by the sixteenth week after death at the latest and asked to participate in a face-to-face interview in their private home. The overall participation rate of all eligible informal caregivers was 76.1% (226/297). The mean burden score was 2.5 (NRS from 0=no burden to 10=maximum burden; n=221). Higher burden scores (≥4) were associated with emotional and burdensome memories (n=34) being invoked throughout the interview. Severe or maximum burden scores (≥7) were stated by 13.2% of participants. The average time between the associated patient's death and the informal caregiver's interview was 57.3 days (range 26-176 days, median 49.5 days). 5.3% of all 226 interviews were not completed due to different reasons. Participants' comments on the way in which the study was conducted gave insight into their motivation to take part in the study and their evaluation of the interview situation. The recruitment strategy can be recommended to other researchers developing research with bereaved carers. The burden caused by study participation was acceptable to the researchers carrying out this research, although a small group of participants experienced high levels of burden which should be anticipated and appropriate support services offered
Blikman, Lyan Jm; van Meeteren, Jetty; Twisk, Jos Wr; de Laat, Fred Aj; de Groot, Vincent; Beckerman, Heleen; Stam, Henk J; Bussmann, Johannes Bj
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.
Weitlauf, Julie C; Ruzek, Josef I; Westrup, Darrah A; Lee, Tina; Keller, Jennifer
A growing body of empirical literature has systematically documented the reactions to research participation among participants in traumafocused research. To date, the available data has generally presented an optimistic picture regarding participants' ability to tolerate and even find benefit from their participation. However, this literature has been largely limited to cross-sectional designs. No extant literature has yet examined the perceptions of participants with psychiatric illness who are participating in randomized clinical trials (RCTs) designed to evaluate the efficacy or effectiveness of novel trauma treatments. The authors posit that negative experiences of, or poor reactions to, the research experience in the context of a trauma-focused RCT may elevate the risk of participation. Indeed, negative reactions may threaten to undermine the potential therapeutic gains of participants and promoting early drop out from the trial. Empirically assessing reactions to research participation at the pilot-study phase of a clinical trial can both provide investigators and IRB members alike with empirical evidence of some likely risks of participation. In turn, this information can be used to help shape the design and recruitment methodology of the full-scale trial. Using data from the pilot study of the Women's Self-Defense Project as a case illustration, we provide readers with concrete suggestions for empirically assessing participants' perceptions of risk involved in their participation in behaviorally oriented clinical trials.
Young, Lufei; Montgomery, Melody; Barnason, Sue; Schmidt, Cindy; Do, Van
Rural residents diagnosed with cardiovascular disease (CVD) or with CVD-related risks are underrepresented in behavioral intervention trials based on an extensive review of published studies. The low participation rate of rural residents weakens both the internal and external validity of published studies. Moreover, compared to urban residents, limited research exists to describe the unique barriers that limit the participation of rural residents in behavioral intervention trials. The purpose of this review is to identify a conceptual framework (CF) underpinning common barriers faced by rural CVD patients to enroll in behavioral intervention trials. We conducted a literature review using several electronic databases to obtain a representative sample of research articles, synthesized the evidence, and developed a CF to explain the barriers that may affect the research participation rate of rural residents with CVD or related risks. We found our evidence-based CF well explained the barriers for rural CVD patients to take part in behavioral intervention trials. Besides contextual factors (i.e. patient, community and research levels), other common factors impacting rural patients' intent to enroll are lack of awareness and understanding about behavioral trials, limited support from their healthcare providers and social circles, unfavorable attitudes, and the lack of opportunity to participating research. The findings demonstrate the evidence-based model consisting of interlinked multi-level factors may help our understanding of the barriers encountered by rural CVD patients participating interventions to promote behavioral change. The implication for researchers is that identifying and developing strategies to overcome the barriers precedes conducting studies in rural communities.
Harris, Keith M; Goh, Melissa Ting-Ting
There is considerable debate on whether suicide assessment carries an iatrogenic risk for participants/patients. A double-blind randomized controlled trial (registration: R000022314) tested the emotional impact of suicide assessment on participants (n = 259) randomly assigned to experimental (n = 122) or control conditions (n = 137). The experimental condition included the Suicidal Affect-Behavior-Cognition Scale and intensive death-related questions, the control condition a quality of life scale. Both included measures of depression, social support and loneliness. Affective states were assessed immediately before and after testing, and research biases minimized. Post-test debriefing interviews collected qualitative reactions. Experimental participants ranged from nonsuicidal to highly suicidal. Between-groups ANCOVAs and repeated measures ANOVAs showed no differences by study condition, and no pre-post-test affect changes for either condition or suicidal participants (P > 0.10), supporting the null hypothesis of no iatrogenic effects. However, depressive participants in both conditions showed significant decreases in positive affect (P suicidality or other factors, predicted negative affect changes, which was supported by qualitative findings. Social desirability bias was also found in qualitative survey responses. No evidence of iatrogenic effects of suicide assessment were found. Recommendations are made to counter possible negative assessment effects on depressive participants/patients, and nurses and other caregivers are encouraged to talk to patients about suicidal symptoms. © 2016 Australian College of Mental Health Nurses Inc.
de Wijkerslooth, Thomas R.; de Haan, Margriet C.; Stoop, Esther M.; Bossuyt, Patrick M.; Thomeer, Maarten; van Leerdam, Monique E.; Essink-Bot, Marie-Louise; Fockens, Paul; Kuipers, Ernst J.; Stoker, Jaap; Dekker, Evelien
OBJECTIVES: We compared reported reasons for participation and nonparticipation in colorectal cancer (CRC) screening between colonoscopy and computed tomographic (CT) colonography in a randomized controlled trial. METHODS: We randomly invited 8,844 people for screening by colonoscopy or CT
Rocheleau Carissa M
Full Text Available Abstract Background Many epidemiological and public health surveys report increasing difficulty obtaining high participation rates. We conducted a pilot follow-up study to determine whether a mailed or telephone survey would better facilitate data collection in a subset of respondents to an earlier telephone survey conducted as part of the National Birth Defects Prevention Study. Methods We randomly assigned 392 eligible mothers to receive a self-administered, mailed questionnaire (MQ or a computer-assisted telephone interview (CATI using similar recruitment protocols. If mothers gave permission to contact the fathers, fathers were recruited to complete the same instrument (MQ or CATI as mothers. Results Mothers contacted for the MQ, within all demographic strata examined, were more likely to participate than those contacted for the CATI (86.6% vs. 70.6%. The median response time for mothers completing the MQ was 17 days, compared to 29 days for mothers completing the CATI. Mothers completing the MQ also required fewer reminder calls or letters to finish participation versus those assigned to the CATI (median 3 versus 6, though they were less likely to give permission to contact the father (75.0% vs. 85.8%. Fathers contacted for the MQ, however, had higher participation compared to fathers contacted for the CATI (85.2% vs. 54.5%. Fathers recruited to the MQ also had a shorter response time (median 17 days and required fewer reminder calls and letters (median 3 reminders than those completing the CATI (medians 28 days and 6 reminders. Conclusions We concluded that offering a MQ substantially improved participation rates and reduced recruitment effort compared to a CATI in this study. While a CATI has the advantage of being able to clarify answers to complex questions or eligibility requirements, our experience suggests that a MQ might be a good survey option for some studies.
Hansen, Marie J; Rasmussen, Nana Ø; Chung, Grace
We have developed a method for extracting the number of trial participants from abstracts describing randomized controlled trials (RCTs); the number of trial participants may be an indication of the reliability of the trial. The method depends on statistical natural language processing. The number of interest was determined by a binary supervised classification based on a support vector machine algorithm. The method was trialled on 223 abstracts in which the number of trial participants was identified manually to act as a gold standard. Automatic extraction resulted in 2 false-positive and 19 false-negative classifications. The algorithm was capable of extracting the number of trial participants with an accuracy of 97% and an F-measure of 0.84. The algorithm may improve the selection of relevant articles in regard to question-answering, and hence may assist in decision-making.
Full Text Available Abstract Background What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. Methods/Design A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participants who indicate a hazardous level of alcohol consumption will be randomly assigned to one of three groups. Group A will be informed their drinking will be assessed at baseline and again in one month (as in a cohort study design. Group B will be told the study is an intervention trial and they are in the control group. Group C will be told the study is an intervention trial and they are in the intervention group. All will receive exactly the same brief educational material to read. After one month, alcohol intake for the past 4 weeks will be assessed. Discussion The experimental manipulations address subtle and previously unexplored ways in which participant behaviour may be unwittingly influenced by standard practice in trials. Given the necessity of relying on self-reported outcome, it will not be possible to distinguish true behaviour change from reporting artefact. This does not matter in the present study, as any effects of awareness of study design or allocation involve bias that is not well understood. There has been little research on awareness effects, and our outcomes will provide an indication of the possible value of further studies of this type and inform hypothesis generation. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000846022
de Bot, Cindy M A; Moed, Heleen; Berger, Marjolein Y; Röder, Esther; de Groot, Hans; de Jongste, Johan C; van Wijk, Roy Gerth; van der Wouden, Johannes C
For respiratory allergic disorders in children, sublingual immunotherapy has been developed as an alternative to subcutaneous immunotherapy. Sublingual immunotherapy is more convenient, has a good safety profile and might be an attractive option for use in primary care. A randomized double-blind placebo-controlled study was designed to establish the efficacy of sublingual immunotherapy with house dust mite allergen compared to placebo treatment in 6 to 18-year-old children with allergic rhinitis and a proven house dust mite allergy in primary care. Described here are the methodology, recruitment phases, and main characteristics of the recruited children. Recruitment took place in September to December of 2005 and 2006. General practitioners (in south-west Netherlands) selected children who had ever been diagnosed with allergic rhinitis. Children and parents could respond to a postal invitation. Children who responded positively were screened by telephone using a nasal symptom score. After this screening, an inclusion visit took place during which a blood sample was taken for the RAST test. A total of 226 general practitioners invited almost 6000 children: of these, 51% was male and 40% <12 years of age. The target sample size was 256 children; 251 patients were finally included. The most frequent reasons given for not participating were: absence or mildness of symptoms, absence of house dust mite allergy, and being allergic to grass pollen or tree pollen only. Asthma symptoms were reported by 37% of the children. Of the enrolled children, 71% was sensitized to both house dust mite and grass pollen. Roughly similar proportions of children were diagnosed as being sensitized to one, two, three or four common inhalant allergens. Our study was designed in accordance with recent recommendations for research on establishing the efficacy of sublingual immunotherapy; 98% of the target sample size was achieved. This study is expected to provide useful information on
Baren, Jill M; Nathanson, Pam G
The 2005 Academic Emergency Medicine Consensus Conference, "Ethical Conduct of Resuscitation Research," was designed with the goal of developing consensus on important issues for human subjects and researchers surrounding the 1996 federal regulations jointly published by the Department of Health and Human Services and the Food and Drug Administration and known as the Final Rule. These regulations, which guide the conduct of research using the emergency exception from informed consent or waiver of informed consent, have been the subject of much debate in the resuscitation research community. Therefore, the editorial board of Academic Emergency Medicine chose this topic as the subject of their annual consensus conference. This report outlines the methods by which individuals and organizations were recruited to participate, how the conference was advertised, and the way in which participants and nonparticipants were encouraged to communicate before and after the conference. The limitations and potential biases of these methods and activities are also presented.
Ryu, Kyoungho; Choi, Wonjun; Shim, Jaegeum; Song, Taejong
A pulmonary recruitment maneuver (PRM) can effectively reduce post-laparoscopic shoulder pain (PLSP). However, a high-pressure PRM may cause pulmonary barotrauma. This study aimed to evaluate the efficacy and safety of a PRM using two different maximum inspiratory pressures (40 and 60cmH2O) for reducing PLSP. Patients undergoing gynecologic laparoscopy were randomly allocated to a control group (n=30), a 40 cmH2O PRM group (n=30), and a 60 cmH2O PRM group (n=30). In the control group, residual carbon dioxide was removed by passive exsufflation through the port site. In the two intervention groups, the PRM consisting of five manual pulmonary inflations was performed at the end of surgery with a maximum pressure of 40 cmH2O or 60 cmH2O, respectively. Shoulder pain and wound pain were recorded using a visual analogue scale at 24 and 48h postoperatively. Wound pain scores at 24 and 48h post-surgery were not different between the three groups. The PLSP scores in the two intervention groups were significantly lower than that seen in the control group at 24 and 48h postoperatively (P=0.006 and P<0.001, respectively). However, there were no statistically significant differences in the PLSP scores between the two intervention groups. A low-pressure PRM (40cmH2O) is as effective as a high-pressure PRM (60cmH2O) for removing residual gas from the peritoneal cavity. PRM using a maximal inspiratory pressure of 40cmH2O is safe and efficacious for the reduction of PLSP. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
de Bock, Martin; Derraik, José G B; Brennan, Christine M; Biggs, Janene B; Smith, Greg C; Cameron-Smith, David; Wall, Clare R; Cutfield, Wayne S
We aimed to assess the effects of psyllium supplementation on insulin sensitivity and other parameters of the metabolic syndrome in an at risk adolescent population. This study encompassed a participant-blinded, randomized, placebo-controlled, crossover trial. Subjects were 47 healthy adolescent males aged 15-16 years, recruited from secondary schools in lower socio-economic areas with high rates of obesity. Participants received 6 g/day of psyllium or placebo for 6 weeks, with a two-week washout before crossing over. Fasting lipid profiles, ambulatory blood pressure, auxological data, body composition, activity levels, and three-day food records were collected at baseline and after each 6-week intervention. Insulin sensitivity was measured by the Matsuda method using glucose and insulin values from an oral glucose tolerance test. 45 subjects completed the study, and compliance was very high: 87% of participants took >80% of prescribed capsules. At baseline, 44% of subjects were overweight or obese. 28% had decreased insulin sensitivity, but none had impaired glucose tolerance. Fibre supplementation led to a 4% reduction in android fat to gynoid fat ratio (p = 0.019), as well as a 0.12 mmol/l (6%) reduction in LDL cholesterol (p = 0.042). No associated adverse events were recorded. Dietary supplementation with 6 g/day of psyllium over 6 weeks improves fat distribution and lipid profile (parameters of the metabolic syndrome) in an at risk population of adolescent males. Australian New Zealand Clinical Trials Registry ACTRN12609000888268.
Martin de Bock
Full Text Available AIMS: We aimed to assess the effects of psyllium supplementation on insulin sensitivity and other parameters of the metabolic syndrome in an at risk adolescent population. METHODS: This study encompassed a participant-blinded, randomized, placebo-controlled, crossover trial. Subjects were 47 healthy adolescent males aged 15-16 years, recruited from secondary schools in lower socio-economic areas with high rates of obesity. Participants received 6 g/day of psyllium or placebo for 6 weeks, with a two-week washout before crossing over. Fasting lipid profiles, ambulatory blood pressure, auxological data, body composition, activity levels, and three-day food records were collected at baseline and after each 6-week intervention. Insulin sensitivity was measured by the Matsuda method using glucose and insulin values from an oral glucose tolerance test. RESULTS: 45 subjects completed the study, and compliance was very high: 87% of participants took >80% of prescribed capsules. At baseline, 44% of subjects were overweight or obese. 28% had decreased insulin sensitivity, but none had impaired glucose tolerance. Fibre supplementation led to a 4% reduction in android fat to gynoid fat ratio (p = 0.019, as well as a 0.12 mmol/l (6% reduction in LDL cholesterol (p = 0.042. No associated adverse events were recorded. CONCLUSIONS: Dietary supplementation with 6 g/day of psyllium over 6 weeks improves fat distribution and lipid profile (parameters of the metabolic syndrome in an at risk population of adolescent males. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12609000888268.
Bergenmar, Mia; Johansson, Hemming; Wilking, Nils; Hatschek, Thomas; Brandberg, Yvonne
Patient information in cancer clinical trial is challenging. The value of audio-recording interventions for patients considering participating in clinical trials is unclear. The primary aim of this randomized study was to investigate effects of audio-recorded information on knowledge and understanding in patients considering participation in a clinical trial. Patients scheduled for information about a phases 2 or 3 trial by one of the 13 participating oncologists at the Department of Oncology during the study period (2008-2013) were eligible. The intervention consisted of an audio-recording on compact disc (CD) of the information at the medical consultation in which the patients were informed about a trial. Knowledge and understanding was measured by the questionnaire, Quality of Informed Consent. A total of 130 patients were randomized, 70% of the calculated sample size (n = 186). Sixty-seven patients were randomized to the intervention. In total, 101 patients (78%) completed questionnaires. No statistical significant differences were found between the groups with respect to knowledge and understanding. The level of knowledge was relatively high, with the exceptions of the risks associated with, and the unproven nature of, the trial. Overall, patients who declined participation scored statistically significant lower on knowledge. The present study was underpowered and the results should therefore be interpreted with caution. Still, 130 patients were included with a response rate of 78%. A CD including the oral information about a clinical trial did not show any effects on knowledge or understanding. However, the levels of knowledge were high, possible due to the high levels of education in the study group. Information on risks associated with the trial is still an area for improvement.
Tinkler, Linda; Smith, Victoria; Yiannakou, Yan; Robinson, Lisa
The aim of this study was to explore the experiences of Clinical Research Nurses, with an emphasis on factors that may have an impact on successful study delivery. The Clinical Research Nurse workforce is pivotal to improving health outcomes through supporting research-active health economies. Investment in research infrastructure has led to nurses and midwives increasingly undertaking extended roles to deliver clinical research. Despite such opportunities, the recruitment of sufficient participants into research studies remains problematic. A growing body of literature is exploring barriers to successful study delivery, indicating the emergence of a caring-recruiting dichotomy in clinical research staff. This qualitative study investigates the experiences of Clinical Research Nurses delivering research in the United Kingdom National Health Service. Four Focus groups (total 19 participants) were conducted in a large North East National Health Service Foundation Trust from November 2015 - February 2016. Thematic analysis identified perceptions of the role in the wider context of professional identity. Role transition, altered relationships and workload complexity, affected participants' practice, leading to inconsistency between core clinical values and perceived identities as research delivery staff. A duty of care as patient advocates contrasted elements of the work reflecting that of salespeople. The emotional labour of approaching patients and unease regarding peer perceptions of the Clinical Research Nurse role, affected the positive aspects of research delivery. Professional-identity and self-concept appear to have an impact on practice in a research delivery role. Further research should explore these issues further, to enlighten the basis on which such feelings are positioned and to work towards practical solutions. © 2017 John Wiley & Sons Ltd.
Veenhof, C.; Dekker, J.; Bijlsma, J.W.J.; Ende, C.H.M. van den
OBJECTIVE: To examine the effect of 2 different recruitment methods on the characteristics of participants with osteoarthritis (OA) of the hip or knee and on the efficacy of an exercise program. METHODS: In a clinical trial on the effectiveness of exercise therapy in OA of the hip or knee, 2 groups
Azher, Hinna; Lay, Jennifer; Stupart, Douglas A; Guest, Glenn D; Watters, David A K
To determine the patient, doctor and student perceptions with different styles of student participation in a surgical outpatient clinic. A randomized controlled trial was conducted in surgical outpatients. Participants included patients scheduled to see one of four specialist general surgeons, the surgeons themselves and third-year medical students undertaking their general surgery rotation at the Geelong Hospital. A total of 151 consultations were randomized to one of three consultation styles between August 2011 and August 2012. (i) 'No Student', consultation without a student being present, (ii) 'Student with Doctor', consultation where the student accompanied the doctor throughout the consultation and (iii) 'Student before Doctor', consultation where the student interviewed the patient before the doctor and examined the patient in the doctor's presence. Participants' perceptions and experience of each of the consultations was assessed in the form of written questionnaires. There was no difference in overall patient satisfaction with different styles of student participation (P = 0.080). Students showed a clear preference for the 'Student before Doctor' consultation style (P = 0.023). There were no differences in consultation outcomes from the doctor's perspective (P = 0.88), except time (P consultation where students are actively involved in patient care as it has no adverse effects on patient satisfaction and it is the preferred participation style from the student's perspective. Doctors do not feel that active student involvement interferes with their ability to deliver healthcare except that it prolongs consultation time. © 2013 The Authors. ANZ Journal of Surgery © 2013 Royal Australasian College of Surgeons.
Fei, Jia; Chen, Junjie
Transcription-coupled repair (TCR) is the major pathway involved in the removal of UV-induced photolesions from the transcribed strand of active genes. Two Cockayne syndrome (CS) complementation group proteins, CSA and CSB, are important for TCR repair. The molecular mechanisms by which CS proteins regulate TCR remain elusive. Here, we report the characterization of KIAA1530, an evolutionarily conserved protein that participates in this pathway through its interaction with CSA and the TFIIH complex. We found that UV irradiation led to the recruitment of KIAA1530 onto chromatin in a CSA-dependent manner. Cells lacking KIAA1530 were highly sensitive to UV irradiation and displayed deficiency in TCR. In addition, KIAA1530 depletion abrogated stability of the CSB protein following UV irradiation. More excitingly, we found that a unique CSA mutant (W361C), which was previously identified in a patient with UV(s)S syndrome, showed defective KIAA1530 binding and resulted in a failure of recruiting KIAA1530 and stabilizing CSB after UV treatment. Together, our data not only reveal that KIAA1530 is an important player in TCR but also lead to a better understanding of the molecular mechanism underlying UV(s)S syndrome.
Santoyo-Olsson, Jasmine; Cabrera, Julissa; Freyre, Rachel; Grossman, Melanie; Alvarez, Natalie; Mathur, Deepika; Guerrero, Maria; Delgadillo, Adriana T.; Kanaya, Alka M.; Stewart, Anita L.
Purpose: To conduct and evaluate a two-phased community-based approach to recruit lower socioeconomic status, minority, or Spanish-speaking adults at risk of developing diabetes to a randomized trial of a lifestyle intervention program delivered by a public health department. Design: Within geographic areas comprising our target population, 4 community organizations provided local space for conducting the study and program. Phase I—outreach in venues surrounding these organizations—included d...
Aretha, D; Fligou, F; Kiekkas, P; Messini, C; Panteli, E; Zintzaras, E; Karanikolas, M
During cesarean section, the supine position reduces functional residual capacity and worsens lung compliance. We tested the hypothesis that alveolar recruitment maneuvers and positive end-expiratory pressure improve lung compliance in women undergoing general anesthesia for cesarean section. Ninety women undergoing cesarean section were randomly assigned to one of two groups in a prospective, double-blind trial. In the alveolar recruitment maneuver group, pressure-control ventilation was used and inspiratory time was increased to 50% after delivery; positive end-expiratory pressure was increased to 20cmH 2 O and peak airway inspiratory pressure gradually increased to 45-50cmH 2 O. Volume-control ventilation was then used with low tidal volumes (6mL/kg) and positive end-expiratory pressure was reduced stepwise to 8cmH 2 O. In the control group, alveolar recruitment maneuvers were not used. Data were collected before and 3, 10 and 20min after the alveolar recruitment maneuver, before extubation and postoperatively at 10 and 20min. Dynamic compliance, peak airway inspiratory pressure, PaO 2 and PaO 2 /FiO 2 were significantly different in the alveolar recruitment maneuver group compared to controls at all time points during surgery except at baseline. Oxygen saturation was significantly greater in the alveolar recruitment maneuver group at 10 and 20min and before extubation. Dynamic compliance was 29.7-42.5% higher and peak airway inspiratory pressure 3.6-10.2% lower in the alveolar recruitment maneuver group compared to controls. The PaO 2 , PaO 2 /FiO 2 and oxygen saturation were higher (9.4-12%, 10.3-11.9% and 0.4-1.3%, respectively) in the alveolar recruitment maneuver group. Postoperatively, PaO 2 and oxygen saturation were significantly higher in the alveolar recruitment maneuver group compared to controls (PaO 2 9.2% at 10min and 8.4% at 20min, oxygen saturation 0.8% at 10min and 1.1% at 20min). There were no significant differences in hemodynamic stability or
Brodar, Kaitlyn E; Hall, Marissa G; Butler, Eboneé N; Parada, Humberto; Stein-Seroussi, Al; Hanley, Sean; Brewer, Noel T
To help tobacco control research better include vulnerable populations, we sought to identify effective ways to recruit diverse smokers. In 2014-2015, we recruited 2149 adult cigarette smokers in California and North Carolina, United States, to participate in a randomized trial of pictorial cigarette pack warnings. The most effective means of recruiting smokers were the classified advertising website Craigslist (28% of participants), word of mouth (23%), Facebook (16%), and flyers or postcards (14%). Low-income and African American smokers were more likely to respond to interpersonal contact (including staff in-person recruitment and word of mouth) than were high-income and non-African American smokers (all p < 0.05). Hispanic and gay, lesbian, and bisexual smokers were more likely to be recruited by Craigslist than non-Hispanic and straight smokers (both p < 0.05). Of the recruitment methods requiring cost, the cheapest was Craigslist ($3-7 per smoker). The most expensive methods were newspaper ads in California ($375 per smoker) and staff in-person recruiting in North Carolina ($180 per smoker). Successfully recruiting diverse smokers requires using multiple methods including interpersonal, online, and other media. Craigslist and word of mouth are especially useful and low-cost ways to recruit diverse smokers.
Kaitlyn E. Brodar
Full Text Available To help tobacco control research better include vulnerable populations, we sought to identify effective ways to recruit diverse smokers. In 2014–2015, we recruited 2149 adult cigarette smokers in California and North Carolina, United States, to participate in a randomized trial of pictorial cigarette pack warnings. The most effective means of recruiting smokers were the classified advertising website Craigslist (28% of participants, word of mouth (23%, Facebook (16%, and flyers or postcards (14%. Low-income and African American smokers were more likely to respond to interpersonal contact (including staff in-person recruitment and word of mouth than were high-income and non-African American smokers (all p < 0.05. Hispanic and gay, lesbian, and bisexual smokers were more likely to be recruited by Craigslist than non-Hispanic and straight smokers (both p < 0.05. Of the recruitment methods requiring cost, the cheapest was Craigslist ($3–7 per smoker. The most expensive methods were newspaper ads in California ($375 per smoker and staff in-person recruiting in North Carolina ($180 per smoker. Successfully recruiting diverse smokers requires using multiple methods including interpersonal, online, and other media. Craigslist and word of mouth are especially useful and low-cost ways to recruit diverse smokers.
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
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.
Moen, M H; Bongers, T; Bakker, E W P; Weir, A; Zimmermann, W O; van der Werve, M; Backx, F J G
To study the additional effect of a pneumatic leg brace with standard rehabilitation for the treatment of medial tibial stress syndrome (MTSS) in recruits. In a single blinded randomized study, 15 recruits (age 17-22) followed a rehabilitation programme consisting of leg exercises and a graded running programme. Recruits performed daily exercises and ran three times a week. The running programme consisted of 6 consecutive phases. One group was, after randomization, additionally provided with a pneumatic leg brace. Follow-up was provided every other week. Days to completing the running programme was the primary outcome measure, the Sports Activity Rating Scale (SARS) score and satisfaction with the treatment were secondary outcome measures. In total 14 recruits completed the rehabilitation programme. No differences were found in the number of days until phase six of the running schedule was finished between the brace and the control group (Brace 58.8 +/- 27.7 (mean +/- SD) vs Non-Brace 57.9 +/- 26.2 (mean +/- SD, p = 0.57). Also no differences were found in the SARS scores between the groups. Overall satisfaction with the treatment was 6.4 +/- 1.1 (mean +/- SD) on a 1-10 scale for the brace group and 7.1 +/- 0.7 (mean +/- SD) for the control group (p = 0.06). Comfort of the brace was assessed as 4.8 +/- 1.3 (mean +/- SD) on a 1-10 scale. No additional large effect of the pneumatic leg brace could be found in recruits and wearing of the brace was not feasible, since the wearing comfort was low.
Sonneville, Kendrin R.; Rifas-Shiman, Sheryl L.; Kleinman, Ken; Gortmaker, Steven; Gillman, Matthew W.; Taveras, Elsie M.
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 ages 2-6.9 years. The main exposures were whether mothers viewed TV/videos Obesogenic behaviors of mothers and pre-school aged children were strongly associated. Our findings lend support to obesity prevention strategies that target parental behavior and the family environment. PMID:22349735
Conclusion: These findings indicate that participants in this Internet trial were not just internet savvy young males without significant impairment. Future studies should aim to recruit participants with lower educational status to increase the reach of Internet interventions.
Japan Diabetes Outcome Intervention Trial-1(J-DOIT1, a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment
Full Text Available Abstract Background Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM. To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach. The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1 is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. Methods For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Results Forty-three groups (clusters, formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups or control arm (21 clusters between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There
Japan Diabetes Outcome Intervention Trial-1(J-DOIT1), a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment
Background Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM). To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach. The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. Methods For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Results Forty-three groups (clusters), formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups) or control arm (21 clusters) between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There were no differences in
Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1), a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment.
Sakane, Naoki; Kotani, Kazuhiko; Takahashi, Kaoru; Sano, Yoshiko; Tsuzaki, Kokoro; Okazaki, Kentaro; Sato, Juichi; Suzuki, Sadao; Morita, Satoshi; Izumi, Kazuo; Kato, Masayuki; Ishizuka, Naoki; Noda, Mitsuhiko; Kuzuya, Hideshi
Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM). To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach.The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Forty-three groups (clusters), formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups) or control arm (21 clusters) between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There were no differences in individual characteristics
Zota, Dina; Dalma, Archontoula; Petralias, Athanassios; Lykou, Anastasia; Kastorini, Christina-Maria; Yannakoulia, Mary; Karnaki, Pania; Belogianni, Katerina; Veloudaki, Afroditi; Riza, Elena; Malik, Rhea; Linos, Athena
To evaluate the potential benefits on students' eating habits, of incorporating healthy nutrition education as part of a school food aid program. 146 schools participating in the DIATROFI Program in Greece during the 2013-2014 school year were randomly allocated to the environmental intervention (received a healthy daily meal) and the multicomponent intervention (MI) group (in addition to the meal, a healthy nutrition educational program was applied). The analysis, based on 3627 pre-post intervention questionnaire pairs, was stratified for children (ages 4-11 years) and adolescents (ages 12-18 years). Children participating in the MI group displayed 25 % higher odds of increasing the weekly consumption of milk/yoghurt and fruits, 61 % higher odds of improving BMI from overweight/obese to normal and 2.5 times higher odds of improving from underweight to normal. For adolescents in the MI group, the odds of increasing the consumption of vegetables were 40 % higher. In both intervention groups, approximately one in four overweight/obese adolescents reached normal weight. Educational programs on healthy nutrition might be considered worth implementing in the framework of school food aid programs.
Sadler, Georgia Robins; Ko, Celine M.; Malcarne, Vanessa L.; Banthia, Rajni; Gutierrez, Ivan; Varni, James W.
Multiple barriers contribute to the slow recruitment of participants to research studies, which in turn extends the time required to translate promising scientific discoveries into proven therapeutic interventions. A small but growing literature is developing on the extraordinary costs of recruiting participants to studies, and thereby demonstrating that underestimating the cost of participant recruitment can contribute to these recruitment problems. These recruitment challenges and costs are exacerbated when the participants’ study eligibility is determined by relatively narrowly defined illness parameters. Recruitment challenges are further compounded when dyads (two individuals engaged in a sociologically significant relationship, such as husbands and wives, siblings or extended families) must be recruited to an illness-focused study. For these latter groups, there are no data to guide researchers in how to anticipate those participant recruitment costs. This paper describes the staff costs for a variety of strategies used to recruit participants to a randomized supportive care study for couples who were within 18 months of a prostate cancer diagnosis. Pegged to the value of the U.S. dollar for the period, the average cost of staff time was $288 per recruited and enrolled dyad, plus a promised additional $100 incentive for study retention. Within the strategies used, the staff costs per recruited dyad ranged from $ 152 to $1,688. Accrual per strategy ranged from zero to 107 enrolled couples. When asked for secondary sources of information about the study, many participants reported more than one source of study referral, reflective of the multifaceted recruitment strategies deployed. In spite of innovative, culturally competent, and broad based recruitment methods, attainment of a diverse sample was difficult to accomplish in this study. Having estimates of the actual cost of recruiting dyads to research studies can help investigators prepare realistic study
Messiah, Antoine; Castro, Grettel; Rodríguez de la Vega, Pura; Acuna, Juan M
Conducting health surveys with community-based random samples are essential to capture an otherwise unreachable population, but these surveys can be biased if the effort to reach participants is insufficient. This study determines the desirable amount of effort to minimise such bias. A household-based health survey with random sampling and face-to-face interviews. Up to 11 visits, organised by canvassing rounds, were made to obtain an interview. Single-family homes in an underserved and understudied population in North Miami-Dade County, Florida, USA. Of a probabilistic sample of 2200 household addresses, 30 corresponded to empty lots, 74 were abandoned houses, 625 households declined to participate and 265 could not be reached and interviewed within 11 attempts. Analyses were performed on the 1206 remaining households. Each household was asked if any of their members had been told by a doctor that they had high blood pressure, heart disease including heart attack, cancer, diabetes, anxiety/ depression, obesity or asthma. Responses to these questions were analysed by the number of visit attempts needed to obtain the interview. Return per visit fell below 10% after four attempts, below 5% after six attempts and below 2% after eight attempts. As the effort increased, household size decreased, while household income and the percentage of interviewees active and employed increased; proportion of the seven health conditions decreased, four of which did so significantly: heart disease 20.4-9.2%, high blood pressure 63.5-58.1%, anxiety/depression 24.4-9.2% and obesity 21.8-12.6%. Beyond the fifth attempt, however, cumulative percentages varied by less than 1% and precision varied by less than 0.1%. In spite of the early and steep drop, sustaining at least five attempts to reach participants is necessary to reduce selection bias. 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.
McGrath, Nuala; D’Alessandro, Umberto; Kampmann, Beate; Imoukhuede, Egeruan B; Ravinetto, Raffaella M; Alexander, Neal; Larson, Heidi J; Chandramohan, Daniel; Bojang, Kalifa
Abstract Objective To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia. Methods 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. Findings 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. Conclusion A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy. PMID:26229203
Glover, Marewa; Kira, Anette; Johnston, Vanessa; Walker, Natalie; Thomas, David; Chang, Anne B; Bullen, Chris; Segan, C J; Brown, Ngiare
Many randomized controlled trials (RCTs) are conducted each year but only a small proportion is specifically designed for Indigenous people. In this review we consider the challenges of participation in RCTs for Indigenous peoples from New Zealand, Australia, Canada and the United States and the opportunities for increasing participation. The literature was systematically searched for published articles including information on the barriers and facilitators for Indigenous people's participation in health-related RCTs. Articles were identified using a key word search of electronic databases (Scopus, Medline and EMBASE). To be included, papers had to include in their published work at least one aspect of their RCT that was either a barrier and/or facilitator for participation identified from, for example, design of intervention, or discussion sections of articles. Articles that were reviews, discussions, opinion pieces or rationale/methodology were excluded. Results were analysed inductively, allowing themes to emerge from the data. Facilitators enabling Indigenous people's participation in RCTs included relationship and partnership building, employing Indigenous staff, drawing on Indigenous knowledge models, targeted recruitment techniques and adapting study material. Challenges for participation included both participant-level factors (such as a distrust of research) and RCT-level factors (including inadequately addressing likely participant barriers (phone availability, travel costs), and a lack of recognition or incorporation of Indigenous knowledge systems. The findings from our review add to the body of knowledge on elimination of health disparities, by identifying effective and practical strategies for conducting and engaging Indigenous peoples with RCTs. Future trials that seek to benefit Indigenous peoples should actively involve Indigenous research partners, and respect and draw on pertinent Indigenous knowledge and values. This review has the potential to
Schwarz, Anne-Sophie; Bilberg, Randi; Bjerregaard, Lene Berit Skov
- The Relay Model. METHOD/DESIGN: The study is a single-blind pragmatic randomized controlled trial including patients admitted to the hospital. The study group (n = 500) will receive an intervention, and the control group (n = 500) will be referred to treatment by usual procedures. All patients complete...
Marino, Christina L; Lascelles, B Duncan X; Vaden, Shelly L; Gruen, Margaret E; Marks, Steven L
Chronic kidney disease (CKD) and degenerative joint disease are both considered common in older cats. Information on the co-prevalence of these two diseases is lacking. This retrospective study was designed to determine the prevalence of CKD in two cohorts of cats: cats randomly selected from four evenly distributed age groups (RS group) and cats recruited for degenerative joint disease studies (DJD group), and to evaluate the concurrence of CKD and DJD in these cohorts. The RS group was randomly selected from four age groups from 6 months to 20 years, and the DJD group comprised cats recruited to four previous DJD studies, with the DJD group excluding cats with a blood urea nitrogen and/or serum creatinine concentration >20% (the upper end of normal) for two studies and cats with CKD stages 3 and 4 for the other two studies. The prevalence of CKD in the RS and DJD groups was higher than expected at 50% and 68.8%, respectively. CKD was common in cats between 1 and 15 years of age, with a similar prevalence of CKD stages 1 and 2 across age groups in both the RS and DJD cats, respectively. We found significant concurrence between CKD and DJD in cats of all ages, indicating the need for increased screening for CKD when selecting DJD treatments. Additionally, this study offers the idea of a relationship and causal commonality between CKD and DJD owing to the striking concurrence across age groups and life stages. PMID:24217707
Marino, Christina L; Lascelles, B Duncan X; Vaden, Shelly L; Gruen, Margaret E; Marks, Steven L
Chronic kidney disease (CKD) and degenerative joint disease are both considered common in older cats. Information on the co-prevalence of these two diseases is lacking. This retrospective study was designed to determine the prevalence of CKD in two cohorts of cats: cats randomly selected from four evenly distributed age groups (RS group) and cats recruited for degenerative joint disease studies (DJD group), and to evaluate the concurrence of CKD and DJD in these cohorts. The RS group was randomly selected from four age groups from 6 months to 20 years, and the DJD group comprised cats recruited to four previous DJD studies, with the DJD group excluding cats with a blood urea nitrogen and/or serum creatinine concentration >20% (the upper end of normal) for two studies and cats with CKD stages 3 and 4 for the other two studies. The prevalence of CKD in the RS and DJD groups was higher than expected at 50% and 68.8%, respectively. CKD was common in cats between 1 and 15 years of age, with a similar prevalence of CKD stages 1 and 2 across age groups in both the RS and DJD cats, respectively. We found significant concurrence between CKD and DJD in cats of all ages, indicating the need for increased screening for CKD when selecting DJD treatments. Additionally, this study offers the idea of a relationship and causal commonality between CKD and DJD owing to the striking concurrence across age groups and life stages. © ISFM and AAFP 2013.
Full Text Available Abstract Background Acute respiratory distress syndrome (ARDS is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART. Methods/Design ART is a pragmatic, multicenter, randomized (concealed, controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy. We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH2O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet. In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight and targeting plateau pressure ≤30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion If the ART strategy with maximum recruitment and PEEP titration improves
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
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
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).
Sun, Jing; Patel, Falguni; Kirzner, Rachel; Newton-Famous, Nijah; Owens, Constance; Welles, Seth L; Chilton, Mariana
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
Voshaar, Richard C Oude; Gorgels, Wim J; Mol, Audrey J; van Balkom, Anton J; Mulder, Jan; van de Lisdonk, Eloy H; Breteler, Marinus H; Zitman, Frans G
To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in general practice. Of 180 patients, we completed follow-up for 170 (94%). Of these, 50 (29%) achieved long-term success, defined as no use of benzodiazepines during follow-up. Independent predictors of success were as follows: offering a taper-off program with group therapy (hazard ratio [HR] 2.4; 95% confidence interval [CI], 1.5 to 3.9) or without group therapy (HR 2.9; 95% CI, 1.8 to 4.8); a lower daily benzodiazepine dosage at the start of tapering off (HR 1.5; 95% CI, 1.2 to 1.9); a substantial dosage reduction by patients themselves just before the start of tapering off (HR 2.1; 95% CI, 1.4 to 3.3); less severe benzodiazepine dependence, as measured by the Benzodiazepine Dependence Self-Report Questionnaire Lack of Compliance subscale (HR 2.4; 95%CI, 1.1 to 5.2); and no use of alcohol (HR 1.7; 95% CI, 1.2 to 2.5). Patients who used over 10 mg of diazepam equivalent, who had a score of 3 or more on the Lack of Compliance subscale, or who drank more than 2 units of alcohol daily failed to achieve long-term abstinence. Benzodiazepine dependence severity affects long-term taper outcome independent of treatment modality, benzodiazepine dosage, psychopathology, and personality characteristics. An identifiable subgroup needs referral to specialized care.
Breaugh, James A
The way an organization recruits can influence the type of employees it hires, how they perform, and their retention rate. This article provides a selective review of research that has addressed recruitment targeting, recruitment methods, the recruitment message, recruiters, the organizational site visit, the job offer, and the timing of recruitment actions. These and other topics (e.g., the job applicant's perspective) are discussed in terms of their potential influence on prehire (e.g., the quality of job applicants) and posthire (e.g., new employee retention) recruitment outcomes. In reviewing research, attention is given to the current state of scientific knowledge, limitations of previous research, and important issues meriting future investigation.
Pradhan, M.; Suryadarma, D.; Beatty, A.; Wong, M.; Alishjabana, A.; Gaduh, A.
This study evaluates the effect of four randomized interventions aimed at strengthening school committees, and subsequently improving learning outcomes, in public primary schools in Indonesia. All study schools were randomly allocated to either a control group receiving no intervention, or to
de Jongste Johan C
Full Text Available Abstract Background For respiratory allergic disorders in children, sublingual immunotherapy has been developed as an alternative to subcutaneous immunotherapy. Sublingual immunotherapy is more convenient, has a good safety profile and might be an attractive option for use in primary care. A randomized double-blind placebo-controlled study was designed to establish the efficacy of sublingual immunotherapy with house dust mite allergen compared to placebo treatment in 6 to18-year-old children with allergic rhinitis and a proven house dust mite allergy in primary care. Described here are the methodology, recruitment phases, and main characteristics of the recruited children. Methods Recruitment took place in September to December of 2005 and 2006. General practitioners (in south-west Netherlands selected children who had ever been diagnosed with allergic rhinitis. Children and parents could respond to a postal invitation. Children who responded positively were screened by telephone using a nasal symptom score. After this screening, an inclusion visit took place during which a blood sample was taken for the RAST test. Results A total of 226 general practitioners invited almost 6000 children: of these, 51% was male and 40% Conclusion Our study was designed in accordance with recent recommendations for research on establishing the efficacy of sublingual immunotherapy; 98% of the target sample size was achieved. This study is expected to provide useful information on sublingual immunotherapy with house dust mite allergen in primary care. The results on efficacy and safety are expected to be available by 2010. Trial registration the trial is registered as ISRCTN91141483 (Dutch Trial Register
Effective recruitment of participants to a phase I study using the internet and publicity releases through charities and patient organisations: analysis of the adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D).
Heywood, James; Evangelou, Marina; Goymer, Donna; Kennet, Jane; Anselmiova, Katerina; Guy, Catherine; O'Brien, Criona; Nutland, Sarah; Brown, Judy; Walker, Neil M; Todd, John A; Waldron-Lynch, Frank
A barrier to the successful development of new disease treatments is the timely recruitment of participants to experimental medicine studies that are primarily designed to investigate biological mechanisms rather than evaluate clinical efficacy. The aim of this study was to analyse the performance of three recruitment sources and the effect of publicity events during the Adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D). The final study outcome, demography, disease duration, residence and the effect of publicity events on the performance of three recruitment sources (clinics, type 1 diabetes (T1D) disease register and the internet) were analysed from a bespoke DILT1D recruitment database. For the internet source, the origin of website hits in relation to publicity events was also evaluated. A total of 735 potentially eligible participants were approached to identify the final 45 DILT1D participants. A total of 477 (64%) were identified via the disease register, but only 59 (12%) responded to contact. A total of 317 individuals registered with the DILT1D study team. Self-referral via the study website generated 170 (54%) registered individuals and was the most popular and successful source, with 88 (28%) sourced from diabetes clinics and 59 (19%) from the disease register. Of those with known T1D duration (N = 272), the internet and clinics sources identified a larger number (57, 21%) of newly diagnosed T1D (March 2013); DRN767 (registered: 21 January 2013).
Full Text Available To investigate changes of muscle recruitment and coordination following constraint-induced movement therapy, constraint-induced movement therapy plus electrical stimulation, and traditional occupational therapy in treating hand dysfunction.In a randomized, single-blind, controlled trial, children with hemiplegic cerebral palsy were randomly assigned to receive constraint-induced movement therapy (n = 22, constraint-induced movement therapy plus electrical stimulation (n = 23, or traditional occupational therapy (n = 23. Three groups received a 2-week hospital-based intervention and a 6-month home-based exercise program following hospital-based intervention. Constraint-induced movement therapy involved intensive functional training of the involved hand during which the uninvolved hand was constrained. Electrical stimulation was applied on wrist extensors of the involved hand. Traditional occupational therapy involved functional unimanual and bimanual training. All children underwent clinical assessments and surface electromyography (EMG at baseline, 2 weeks, 3 and 6 months after treatment. Surface myoelectric signals were integrated EMG, root mean square and cocontraction ratio. Clinical measures were grip strength and upper extremity functional test.Constraint-induced movement therapy plus electrical stimulation group showed both a greater rate of improvement in integrated EMG of the involved wrist extensors and cocontraction ratio compared to the other two groups at 3 and 6 months, as well as improving in root mean square of the involved wrist extensors than traditional occupational therapy group (p<0.05. Positive correlations were found between both upper extremity functional test scores and integrated EMG of the involved wrist as well as grip strength and integrated EMG of the involved wrist extensors (p<0.05.Constraint-induced movement therapy plus electrical stimulation is likely to produce the best outcome in improving muscle recruitment
investigações adicionais baseado nos achados do ECG de 12 derivações deve ser criterioso.BACKGROUND:The findings and additional investigations required based on pre-participation electrocardiography (ECG among military recruits are poorly defined in the literature. OBJECTIVES: This study was designed to evaluate the rate of abnormal findings on pre-participation ECG in young adults and the additional evaluations required based on these findings. METHODS: A retrospective cohort study was performed in the Israeli Air Force (IAF aero medical screening center for flight academy and elite units' candidates. Flight academy and elite units' candidates undergo pre-participation ECG prior to enlistment to the Israeli Defense Forces (IDF. Since 2010, all ECGS have been performed at the IAF aero medical center. All ECGs performed since January 2010 were analyzed by one of three cardiologists and all those in which significant findings were identified were referred to further evaluation upon the cardiologist's request. Causes of referral for further evaluation, the evaluations performed and the results of these evaluations are reported for the study population. RESULTS: 1455 ECGS were performed in the years 2010-2011. Of these, 1388 (95.39% were interpreted as normal. 67 subjects were referred to further evaluation based on ECG findings. The most common findings leading to further evaluation were T wave changes (16 cases, 23.88%, pre-excitation pattern (14, 20.89% and voltage criteria for left ventricular hypertrophy (11, 16.41%. Only 7 subjects (10.44% had abnormal findings which were considered clinically significant at the end of the medical evaluation. CONCLUSIONS: The rate of significant findings leading to disqualification from military activity is extremely low and referral to continued investigations based on 12-lead ECG findings should be judicious.
School Of Medicine, University Of California Davis
The University of California Davis, School of Medicine, Department of Dermatology is recruiting for a full-time position at the Associate or Full Professor level in the Clinical X Series or Health Sciences Clinical Professor (HSCP) Series. The successful candidate is nominated to be the holder of the Frederick G. Novy, Jr. M.D Endowed Professorship. Appointees to the ClinX series are expected to conduct independent research. Both series require significant participation in teaching and University/public service.The holder of the Frederick G. Novy, Jr. M.D. Endowed Professorship will be a nationally recognized scholar and clinician whose role would emphasize clinical education and, potentially, clinical research. A history of lecturing at national forums would be expected of the Novy Professorship holder. He /She will serve in a leadership capacity for educational issues in the department including a strong involvement with the dermatology residency program and medical student curriculum in the area of dermatology.Administrative responsibility within the Dermatology Clinic, which sees over 32,000 patient visits a year, is possible, based on departmental need. The Novy Professor will have oversight of the Volunteer Clinical Faculty Program, Grand Rounds, Novy Lecture Series, and community interactions. This person would undertake clinical, educational, scholarly, and publication commitments and would play an active role in the Department, the Medical School, UC Davis Health System, and the community.Required candidate qualifications include: an M.D. or D.O. degree, board certification or eligibility in Dermatology, eligibility for medical licensure in the state of California, an established track record of original research publications, and a record of teaching and patient care in the area of skin diseases. Demonstrated leadership experience and abilities, the ability to adhere to policies and procedures are required. The ability to work cooperatively and
Costa Leme, Alcino; Hajjar, Ludhmila Abrahao; Volpe, Marcia S; Fukushima, Julia Tizue; De Santis Santiago, Roberta Ribeiro; Osawa, Eduardo A; Pinheiro de Almeida, Juliano; Gerent, Aline Muller; Franco, Rafael Alves; Zanetti Feltrim, Maria Ignez; Nozawa, Emília; de Moraes Coimbra, Vera Regina; de Moraes Ianotti, Rafael; Hashizume, Clarice Shiguemi; Kalil Filho, Roberto; Auler, Jose Otavio Costa; Jatene, Fabio Biscegli; Gomes Galas, Filomena Regina Barbosa; Amato, Marcelo Britto Passos
Perioperative lung-protective ventilation has been recommended to reduce pulmonary complications after cardiac surgery. The protective role of a small tidal volume (VT) has been established, whereas the added protection afforded by alveolar recruiting strategies remains controversial. To determine whether an intensive alveolar recruitment strategy could reduce postoperative pulmonary complications, when added to a protective ventilation with small VT. Randomized clinical trial of patients with hypoxemia after cardiac surgery at a single ICU in Brazil (December 2011-2014). Intensive recruitment strategy (n=157) or moderate recruitment strategy (n=163) plus protective ventilation with small VT. Severity of postoperative pulmonary complications computed until hospital discharge, analyzed with a common odds ratio (OR) to detect ordinal shift in distribution of pulmonary complication severity score (0-to-5 scale, 0, no complications; 5, death). Prespecified secondary outcomes were length of stay in the ICU and hospital, incidence of barotrauma, and hospital mortality. All 320 patients (median age, 62 years; IQR, 56-69 years; 125 women [39%]) completed the trial. The intensive recruitment strategy group had a mean 1.8 (95% CI, 1.7 to 2.0) and a median 1.7 (IQR, 1.0-2.0) pulmonary complications score vs 2.1 (95% CI, 2.0-2.3) and 2.0 (IQR, 1.5-3.0) for the moderate strategy group. Overall, the distribution of primary outcome scores shifted consistently in favor of the intensive strategy, with a common OR for lower scores of 1.86 (95% CI, 1.22 to 2.83; P = .003). The mean hospital stay for the moderate group was 12.4 days vs 10.9 days in the intensive group (absolute difference, -1.5 days; 95% CI, -3.1 to -0.3; P = .04). The mean ICU stay for the moderate group was 4.8 days vs 3.8 days for the intensive group (absolute difference, -1.0 days; 95% CI, -1.6 to -0.2; P = .01). Hospital mortality (2.5% in the intensive group vs 4.9% in the moderate group; absolute
Hershberger, Patricia E; Gallo, Agatha M; Molokie, Robert; Thompson, Alexis A; Suarez, Marie L; Yao, Yingwei; Wilkie, Diana J
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.
Full Text Available Orientation: Nurse recruitment to and participation in empirical research is increasingly important in understanding and improving nursing practice. However, the low participation and recruitment rate amongst nurses is not well understood.Research purpose: The aim of this study was to evaluate three research recruitment methods for their impact on recruitment and participation rates amongst South African nurses.Motivation for the study: A limited number of studies exist that formally evaluates different recruitment strategies to improve participation in research amongst nurses within developing contexts, especially South Africa.Research approach, design and method: Participants were recruited using three different methods. Of the 250 nurses randomly selected and invited to participate in a cross-sectional survey, 201 agreed and 162 (81% returned the questionnaires.Main findings: Nursing management participation in the recruitment and data collection process produces more favourable response rates. Reminders and the use of shorter questionnaires also aid higher response rates.Practical/managerial implications: Reminders as well as face-to-face recruitment strategies (especially by a familiar person successfully improved participation rates amongst South African nurses in this study.Contribution/value-add: This study identifies some strategies that could be used more widely to increase the recruitment and participation of South African nurses in research whilst potentially improving their work situation.
Clark, Imogen N; Baker, Felicity A; Peiris, Casey L; Shoebridge, Georgie; Taylor, Nicholas F
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.
Full Text Available Abstract Background In most recent large efficacy trials of barrier contraceptive methods, a high proportion of participants withdrew before the intended end of follow-up. The objective of this analysis was to explore characteristics of participants who failed to complete seven months of planned participation in a trial of spermicide efficacy. Methods Trial participants were expected to use the assigned spermicide for contraception for 7 months or until pregnancy occurred. In bivariable and multivariable analyses, we assessed the associations between failure to complete the trial and 17 pre-specified baseline characteristics. In addition, among women who participated for at least 6 weeks, we evaluated the relationships between failure to complete, various features of their first 6 weeks of experience with the spermicide, and characteristics of the study centers and population. Results Of the 1514 participants in this analysis, 635 (42% failed to complete the study for reasons other than pregnancy. Women were significantly less likely to complete if they were younger or unmarried, had intercourse at least 8 times per month, or were enrolled at a university center or at a center that enrolled fewer than 4 participants per month. Noncompliance with study procedures in the first 6 weeks was also associated with subsequent early withdrawal, but dissatisfaction with the spermicide was not. However, many participants without these risk factors withdrew early. Conclusions Failure to complete is a major problem in barrier method trials that seriously compromises the interpretation of results. Targeting retention efforts at women at high risk for early withdrawal is not likely to address the problem sufficiently.
Sun, Jie; Yi, Hong-Liang; Tan, He-Ping
A local radial basis function meshless scheme (LRBFM) is developed to solve polarized radiative transfer in participating media containing randomly oriented axisymmetric particles in which radial basis functions augmented with polynomial basis are employed to construct the trial functions, and the vector radiative-transfer equation based on the discrete-ordinates approach is discretized directly by collocation method. The LRBFM belongs to a class of truly meshless methods that do not need any mesh or any numerical integration scheme. Performances of the LRBFM are verified with analytical solutions and other numerical results reported earlier in the literature via five various test cases. The predicted angular distribution of brightness temperature and Stokes vector by the LRBFM agree very well with the benchmark. It is demonstrated that the LRBFM is accurate to solve vector radiative transfer in participating media with randomly oriented axisymmetric particles.
Riis, Allan; Jensen, Cathrine Elgaard; Maindal, Helle Terkildsen
Introduction: Health service research often involves the active participation of healthcare professionals. However, their ability and commitment to research varies. This can cause recruitment difficulties and thereby prolong the study period and inflate budgets. Solberg has identified seven R......-factors as determinants for successfully recruiting healthcare professionals: relationships, reputation, requirements, rewards, reciprocity, resolution, and respect. Method: This is a process evaluation of the seven R-factors. We applied these factors to guide the design of our recruitment strategy as well as to make...... adjustments when recruiting general practices in a guideline implementation study. In the guideline implementation study, we studied the effect of outreach visits, quality reports, and new patient stratification tools for low back pain patients. Results: During a period of 15 months, we recruited 60 practices...
Fairbanks, Eileen; Shah, Shivani; Wilde, Mary H; McDonald, Margaret V; Brasch, Judith; McMahon, James M
Effective screening and recruitment are essential to the success of randomized clinical trials. This report is to describe key screening and recruitment strategies in a two site randomized clinical trial (RCT) conducted in community settings with a vulnerable chronically ill population and to suggest valuable approaches when planning trials. Differences between sites in a complex study with two considerably different environments (academic versus home care) and their participant pools presented challenges which required different screening and recruitment methods. A high level of communication between sites, creative problem solving and the ability to be flexible when problems were encountered were needed for successful screening and recruitment. Copyright © 2014 Elsevier Inc. All rights reserved.
Captación de participantes en el programa experimental de prescripción de estupefacientes en Andalucía (PEPSA The experimental drug prescription program in Andalusia (PEPSA: procedure for recruiting participants
Joan Carles March
Full Text Available Esta nota tiene como finalidad describir los pasos seguidos en el proceso de captación de los participantes en el ensayo andaluz de prescripción de heroína intravenosa. El programa experimental de prescripción de estupefacientes en Andalucía (PEPSA compara el tratamiento de heroína respecto a la metadona oral, en la mejoría de la salud física y mental y la integración social. Dada las características de la población diana (usuarios de heroína por vía intravenosa en situación de exclusión social para quienes no han sido efectivos los tratamientos disponibles, se planificó un abordaje específico para acercar dichas personas al estudio. Tras una investigación previa sobre la distribución de la población diana en la ciudad de Granada, se dividió ésta en 3 zonas. Se acudía a los principales centros de reunión (plazas, comedores sociales, dispensarios de metadona y se concretaba una cita con un médico del PEPSA. El trabajo apoyado en iguales ha sido una herramienta fundamental en este proceso de captación, y ha facilitado el acercamiento a la población diana. Asimismo, este trabajo ha permitido entablar contacto con usuarios de drogas que no acceden a los servicios sociosanitarios, por lo que la labor del equipo de captación también ha sido educar en la reducción de daños y ofrecer alternativas sociales y sanitarias más allá del ensayo.In this field note we describe the steps followed in the process of recruiting participants for the experimental drug prescription program in Andalusia (PEPSA. This trial is a comparative, randomized, open study of the difference between intravenous heroin treatment and oral methadone for socially excluded, opiate-dependent patients, in whom other available treatments have been unsuccessful. Because this is a hidden and hard-to-reach population, a specific approach was planned to put as many patients as possible in touch with the program. A previous study of the target population
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.
Coxon, Kristy; Chevalier, Anna; Brown, Julie; Clarke, Elizabeth; Billot, Laurent; Boufous, Soufiane; Ivers, Rebecca; Keay, Lisa
To ascertain whether a safe-transportation program can change driving exposure while maintaining community participation of older drivers. Randomized controlled trial. Northwest Sydney. Drivers aged 75 and older (mean 80 ± 4) (n = 380). Intervention group participated in an individualized, one-on-one safe-transportation program adapted from the Knowledge Enhances Your Safety curriculum. A registered occupational therapist delivered the intervention in two sessions held approximately 1 month apart. An in-vehicle monitoring device hardwired into participants' vehicles measured driving exposure. Community participation was measured using the Keele Assessment of Participation. A staging algorithm based on the Precaution Adoption Process Model measured behavior change toward increased and sustained driving self-regulation. Main outcomes were distance driven per week over 12 months and community participation. Secondary outcomes were behavior change, depressive symptoms, and alternate transportation use. Generalized estimating equations were used to model effect on driving exposure, adjusting for weekly measures, and ordinal regression was used to analyze differences in behavior change profiles between groups using an intention-to-treat approach. Participants were randomized after baseline assessment-190 each to the intervention and control groups. One hundred eighty-three of 190 completed the intervention and 366 of 380 completed the study. On average, participants drove 140 ± 167 km/wk. Although there was no significant difference between the groups in distance driven per week over 12 months (between-group difference -5.5 km, 95% confidence interval (CI) = -24.5-13.5 km, p = .57), intervention group participants showed greater readiness to engage in self-regulatory driving practices, such as reporting avoiding driving at night or at rush hours, than control group participants (odds ratio (OR) = 1.6, 95% CI = 1.1-2.3, P = .02). At 12 months, use of alternate
Heinzerling, Keith G; Swanson, Aimee-Noelle; Hall, Timothy M; Yi, Yi; Wu, Yingnian; Shoptaw, Steven J
Two previous randomized trials found an effect for bupropion in reducing methamphetamine use in the subgroup with lower frequency of methamphetamine use at baseline. This study aimed to replicate these results by comparing bupropion versus placebo in methamphetamine-dependent participants with less than daily methamphetamine use at baseline. Methamphetamine-dependent volunteers reporting methamphetamine use on ≤29 of past 30 days were randomized to bupropion 150 mg twice daily (n = 41) or placebo (n = 43) and out-patient counseling for 12 weeks. The primary outcome was the proportion achieving end-of-treatment (EOT) methamphetamine abstinence (weeks 11 and 12) for bupropion versus placebo. A post-hoc analysis compared EOT abstinence by medication adherence assessed via plasma bupropion/hydroxybupropion level. There was no significant difference in EOT abstinence between bupropion (29%, 12 of 41) and placebo (14%, six of 43; P = 0.087). Among participants receiving bupropion, EOT abstinence was significantly higher in participants assessed as medication adherent by plasma bupropion/hydroxybupropion levels (54%, seven of 13) compared to non-adherent participants (18%, five of 28; P = 0.018). Medication adherence by plasma levels was low (32%). Bupropion may be efficacious for reducing methamphetamine in people with less than daily baseline methamphetamine use, but the evidence remains inconclusive. © 2014 Society for the Study of Addiction.
Azcutia, Veronica; Stefanidakis, Michael; Tsuboi, Naotake; Mayadas, Tanya; Croce, Kevin J; Fukuda, Daiju; Aikawa, Masanori; Newton, Gail; Luscinskas, Francis W
At sites of inflammation, endothelial adhesion molecules bind leukocytes and transmit signals required for transendothelial migration (TEM). We previously reported that adhesive interactions between endothelial cell CD47 and leukocyte signal regulatory protein γ (SIRPγ) regulate human T cell TEM. The role of endothelial CD47 in T cell TEM in vivo, however, has not been explored. In this study, CD47⁻/⁻ mice showed reduced recruitment of blood T cells as well as neutrophils and monocytes in a dermal air pouch model of TNF-α-induced inflammation. Reconstitution of CD47⁻/⁻ mice with wild-type bone marrow cells did not restore leukocyte recruitment to the air pouch, indicating a role for endothelial CD47. The defect in leukocyte TEM in the CD47⁻/⁻ endothelium was corroborated by intravital microscopy of inflamed cremaster muscle microcirculation in bone marrow chimera mice. In an in vitro human system, CD47 on both HUVEC and T cells was required for TEM. Although previous studies showed CD47-dependent signaling required G(αi)-coupled pathways, this was not the case for endothelial CD47 because pertussis toxin, which inactivates G(αi), had no inhibitory effect, whereas G(αi) was required by the T cell for TEM. We next investigated the endothelial CD47-dependent signaling events that accompany leukocyte TEM. Ab-induced cross-linking of CD47 revealed robust actin cytoskeleton reorganization and Src- and Pyk-2-kinase dependent tyrosine phosphorylation of the vascular endothelial-cadherin cytoplasmic tail. This signaling was pertussis toxin insensitive, suggesting that endothelial CD47 signaling is independent of G(αi). These findings suggest that engagement of endothelial CD47 by its ligands triggers outside-in signals in endothelium that facilitate leukocyte TEM.
Morgan, Amy Joanna; Jorm, Anthony Francis; Mackinnon, Andrew James
Recruiting participants to randomized controlled trials of health interventions can be very difficult. Internet-based recruitment is becoming an increasingly important mode of recruitment, yet there are few detailed accounts of experiences recruiting participants to mental health interventions. To report on our experience with Internet-based recruitment to an online depression prevention intervention and pass on lessons we learned. Participants were recruited to the Mood Memos study, an online preventive depression intervention, purely through Internet-based sources. The study was targeted to adults with subthreshold depression symptoms from several English-speaking countries. A variety of online recruitment sources were trialed, including search engine advertising (Google, Yahoo!, Bing), Facebook advertising, posts in forums and online noticeboards, and promotion through relevant websites and email newsletters of mental health organizations. The study website received visits from 94,808 individuals over the 14-month recruitment period. The recruitment target was reached with 1699 individuals signing up to the randomized controlled trial and 1326 fully enrolling. Most visitors arrived via Google advertising, which promoted a depression-screening questionnaire. Google advertising accounted for nearly half of the total participants who signed up to the study, at an average cost of AUD $12 per participant. Promoting the study through trustworthy organizations and websites known to participants was also effective. Recruitment techniques that were less effective were contacting forums, email groups, and community noticeboards. Several techniques, including Google advertising, were successful in recruiting participants to a trial evaluating an online depression intervention. Results suggest that Internet-based recruitment to mental health interventions is feasible and can be relatively affordable. ACTRN12609000925246.
Jorm, Anthony Francis; Mackinnon, Andrew James
Background Recruiting participants to randomized controlled trials of health interventions can be very difficult. Internet-based recruitment is becoming an increasingly important mode of recruitment, yet there are few detailed accounts of experiences recruiting participants to mental health interventions. Objective To report on our experience with Internet-based recruitment to an online depression prevention intervention and pass on lessons we learned. Methods Participants were recruited to the Mood Memos study, an online preventive depression intervention, purely through Internet-based sources. The study was targeted to adults with subthreshold depression symptoms from several English-speaking countries. A variety of online recruitment sources were trialed, including search engine advertising (Google, Yahoo!, Bing), Facebook advertising, posts in forums and online noticeboards, and promotion through relevant websites and email newsletters of mental health organizations. Results The study website received visits from 94,808 individuals over the 14-month recruitment period. The recruitment target was reached with 1699 individuals signing up to the randomized controlled trial and 1326 fully enrolling. Most visitors arrived via Google advertising, which promoted a depression-screening questionnaire. Google advertising accounted for nearly half of the total participants who signed up to the study, at an average cost of AUD $12 per participant. Promoting the study through trustworthy organizations and websites known to participants was also effective. Recruitment techniques that were less effective were contacting forums, email groups, and community noticeboards. Conclusions Several techniques, including Google advertising, were successful in recruiting participants to a trial evaluating an online depression intervention. Results suggest that Internet-based recruitment to mental health interventions is feasible and can be relatively affordable. Trial Registration ACTRN
Heiderscheit, Annie; Breckenridge, Stephanie J; Chlan, Linda L; Savik, Kay
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.
Heiderscheit, Annie; Breckenridge, Stephanie J.; Chlan, Linda L.; Savik, Kay
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
King, Gary; Pan, Jennifer; Roberts, Margaret E
Existing research on the extensive Chinese censorship organization uses observational methods with well-known limitations. We conducted the first large-scale experimental study of censorship by creating accounts on numerous social media sites, randomly submitting different texts, and observing from a worldwide network of computers which texts were censored and which were not. We also supplemented interviews with confidential sources by creating our own social media site, contracting with Chinese firms to install the same censoring technologies as existing sites, and--with their software, documentation, and even customer support--reverse-engineering how it all works. Our results offer rigorous support for the recent hypothesis that criticisms of the state, its leaders, and their policies are published, whereas posts about real-world events with collective action potential are censored. Copyright © 2014, American Association for the Advancement of Science.
Greenley, Rachel N; Gumidyala, Amitha P; Nguyen, Eve; Plevinsky, Jill M; Poulopoulos, Natasha; Thomason, Molly M; Walter, Jennifer G; Wojtowicz, Andrea A; Blank, Ellen; Gokhale, Ranjana; Kirschner, Barbara S; Miranda, Adrian; Noe, Joshua D; Stephens, Michael C; Werlin, Steven; Kahn, Stacy A
Medication nonadherence is associated with higher disease activity, greater health care utilization, and lower health-related quality of life in pediatric inflammatory bowel diseases (IBD). Problem solving skills training (PSST) is a useful tool to improve adherence in patients with chronic diseases but has not been fully investigated in IBD. This study assessed feasibility, acceptability, and preliminary efficacy of PSST in pediatric IBD. Recruitment occurred during outpatient clinic appointments. After completion of baseline questionnaires, families were randomized to a treatment group or wait-list comparison group. The treatment group received either 2 or 4 PSST sessions. Youth health-related quality of life was assessed at 3 time points, and electronic monitoring of oral medication adherence occurred for the study duration. Seventy-six youth (ages 11-18 years) on an oral IBD maintenance medication participated. High retention (86%) and treatment fidelity rates (95%) supported feasibility. High satisfaction ratings (mean values ≥4.2 on 1-5 scale) supported intervention acceptability. Modest increases in adherence occurred after 2 PSST sessions among those with imperfect baseline adherence (d = 0.41, P 0.05). Phone-delivered PSST was feasible and acceptable. Efficacy estimates were similar to those of lengthier interventions conducted in other chronic illness populations. Older adolescents benefited more from the intervention than their younger counterparts.
Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C
Background The Systolic Blood Pressure Intervention Trial (SPRINT) is a multicenter, randomized clinical trial of 9,361 participants with hypertension who are ≥ 50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the SPRINT cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥ 75 years, women, and minorities. Methods In collaboration with the National Institutes of Health Project Office and SPRINT Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began November 8, 2010 and ended March 15, 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Results Recruitment was scheduled to last 24 months to enroll a target of 9,250 participants; in just over 28 months, the trial enrolled 9,361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by SPRINT staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized /number screened) was 64% (9,361 randomized /14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those age ≥ 75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional clinics were included and inclusion criteria were broadened, keeping event rates
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
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 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.
Olstad, Dana Lee; Crawford, David A; Abbott, Gavin; McNaughton, Sarah A; Le, Ha Nd; Ni Mhurchu, Cliona; Pollard, Christina; Ball, Kylie
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 χ2 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 (ppurchasing from other stores into study supermarkets 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 ).
Crook, Bradley; Tomlins, Rose; Bancroft, Ann; Ogi, Laura
The importance of making research participation accessible for people with learning disabilities is emphasised in government and NHS research strategies. This evaluation explored the realities of this goal from the perceptions of people with learning disabilities and clinicians within an NHS learning disability service. People with learning…
McHenry, Judith C; Insel, Kathleen C; Einstein, Gilles O; Vidrine, Amy N; Koerner, Kari M; Morrow, Daniel G
Describe recruitment strategies used in a randomized clinical trial of a behavioral prospective memory intervention to improve medication adherence for older adults taking antihypertensive medication. Recruitment strategies represent 4 themes: accessing an appropriate population, communication and trust-building, providing comfort and security, and expressing gratitude. Recruitment activities resulted in 276 participants with a mean age of 76.32 years, and study enrollment included 207 women, 69 men, and 54 persons representing ethnic minorities. Recruitment success was linked to cultivating relationships with community-based organizations, face-to-face contact with potential study participants, and providing service (e.g., blood pressure checks) as an access point to eligible participants. Seventy-two percent of potential participants who completed a follow-up call and met eligibility criteria were enrolled in the study. The attrition rate was 14.34%. The projected increase in the number of older adults intensifies the need to study interventions that improve health outcomes. The challenge is to recruit sufficient numbers of participants who are also representative of older adults to test these interventions. Failing to recruit a sufficient and representative sample can compromise statistical power and the generalizability of study findings. © The Author 2012. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: email@example.com.
Juliard, Jean-Michel; Golmard, Jean-Louis; Feldman, Laurent J; Himbert, Dominique; Nejjari, Mohammed; Ducrocq, Gregory; Sorbets, Emmanuel; Garbarz, Eric; Aubry, Pierre; Duchatelle, Valérie; Vahanian, Alec; Steg, Ph Gabriel
There is uncertainty as to whether consenting and randomizing patients in randomized clinical trials (RCTs) in acute ST-segment elevation myocardial infarction (STEMI) delays reperfusion and increases mortality. The aim of this study was to determine whether participation of patients with STEMI in RCTs is associated with delay in implementation of reperfusion therapy and increased hospital mortality. A consecutive sample of 2523 patients, admitted within 6 hours of symptom onset without cardiogenic shock, was recruited from a single tertiary academic centre. They were categorized according to participation (n=392, 15.5%) or nonparticipation (n=2131, 84.5%) in RCTs of reperfusion therapy. Primary outcome was hospital mortality. Additional outcome was time from symptom onset to receipt of reperfusion therapy. Trial participants were more likely to receive fibrinolysis with a 37 min delay in comparison with patients not included in RCTs. Time from symptom onset to reperfusion (minutes) was longer for trial participants than nonparticipants (246 ± 85 vs 233 ± 93, p=0.01). Hospital mortality was 3.61% for nonparticipants. Expected mortality (based on risk modeling) for trial participants was 2.74% (p=0.014 vs nonparticipants). Observed mortality was 1.53% (p=0.034 vs nonparticipants; p=0.16 vs expected mortality). In a multivariable analysis using logistic regression, participation in a RCT was not an independent correlate of hospital mortality (odds ratio 0.54, 95% confidence interval 0.23-2.43, p=0.16). In this consecutive cohort, despite a longer delay to reperfusion, there was no indication that participation in a RCT, starting before initiation of reperfusion therapy, was associated with a detectable increase in risk of hospital mortality among patients with STEMI. These data suggest that it is possible to consent and randomize patients with STEMI into RCTs without jeopardizing their survival. © The European Society of Cardiology 2015.
Oh, Bumjo; Yi, Ga-Hye; Han, Min Kyu; Kim, Jong Seung; Lee, Chang Hee; Cho, Belong; Kang, Hee Cheol
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
Berge, Eivind; Stapf, Christian; Al-Shahi Salman, Rustam
Background: The success of randomized-controlled stroke trials is dependent on the recruitment and retention of a sufficient number of patients, but fewer than half of all trials meet their target number of patients. Methods: We performed a search and review of the literature, and conducted...... a survey and workshop among 56 European stroke trialists, to identify barriers, suggest methods to improve recruitment and retention, and make a priority list of interventions that merit further evaluation. Results: The survey and workshop identified a number of barriers to patient recruitment...... and retention, from patients’ incapacity to consent, to handicaps that prevent patients from participation in trial-specific follow-up. Methods to improve recruitment and retention may include simple interventions with individual participants, funding of research networks, and reimbursement of new treatments...
Full Text Available Ultraviolet radiation (UVR is one of the most common mutagens encountered by humans and induces the formation of cyclobutane pyrimidine dimers (CPDs and pyrimidine-(6-4-pyrimidone photoproduct (6-4PP lesions in the genomic DNA. To prevent the accumulation of deleterious mutations these lesions must be efficiently repaired, primarily by nucleotide excision repair. We have previously demonstrated that the NR4A family of nuclear receptors are crucial mediators of the DNA repair function of the MC1R signalling pathway in melanocytes. Here we explore the role of the NR4A2 protein in the DNA repair process further. Using EYFP tagged-NR4A2 we have demonstrated a UVR induced recruitment to distinct nuclear foci where they co-localise with known DNA repair proteins. We reveal that the N-terminal domain of the receptor is required for this translocation and identify a role for p38 and PARP signalling in this process. Moreover disruption of the functional integrity of the Ligand Binding Domain of the receptor by deleting the terminal helix 12 effectively blocks co-localisation of the receptor with DNA repair factors. Restored co-localisation of the mutant receptor with DNA repair proteins in the presence of a Histone Deacetylase Inhibitor suggests that impaired chromatin accessibility underpins the mis-localisation observed. Finally NR4A2 over-expression facilitated a more efficient clearance of UVR induced CPD and 6-4PP lesions. Taken together these data uncover a novel role for the NR4A nuclear receptors as direct facilitators of nucleotide excision repair.
Söderqvist, Fredrik; Carlberg, Michael; Zetterberg, Henrik; Hardell, Lennart
There are studies suggesting effects on sleep from pulse-modulated radiofrequency fields used in mobile and cordless phones. So far, reports of adverse effects in observational studies are of limited value for risk assessment while effects from experimental studies seem to be more consistent but unclear as to their importance for health. The aim of this study was to investigate whether use of wireless phones is associated with lower concentrations of β-trace protein (lipocalin-type prostaglandin D synthase), a key enzyme in the synthesis of prostaglandin D(2), an endogenous sleep-promoting neurohormone. Three hundred and fourteen people, aged 18-65 years and living in the municipality of Örebro, Sweden, were recruited randomly using the population registry. Total and age-specific linear regression analyses adjusted for known covariates were used to calculate associations between levels of β-trace protein and short- and long-term use of wireless phones. Overall, no statistically significant association between use of wireless phones and the serum concentration of β-trace protein was found, neither with respect to short-term nor long-term use. Age-specific analyses, however, yielded negative associations for long-term use (cumulative hours of use) and β-trace protein in the youngest age group (18-30 years). This study provided no overall evidence of an association between wireless phone use and serum concentrations of β-trace protein. While the findings in the 18-30 year age group indicating lower concentrations with more cumulative hours of use should be further investigated, no causal inferences can be made from the results of the present study.
Powers, Mark B; Smits, Jasper A J; Otto, Michael W; Sanders, Carlijn; Emmelkamp, Paul M G
Preliminary animal research suggests that yohimbine hydrochloride, a selective competitive alpha2-adrenergic receptor antagonist, accelerates fear extinction and converts ineffective extinction regimens (long intertrial intervals) to effective ones. This randomized placebo controlled study examined the potential exposure enhancing effect of yohimbine hydrochloride in claustrophobic humans. Participants (71% undergraduate students and 29% community volunteers) displaying marked claustrophobic fear (n=24) were treated with 2 1-h in vivo exposure sessions. Participants were randomly allocated to take 10.8mg yohimbine hydrochloride (n=12) or placebo (n=12) prior to each exposure session. Outcome measures included peak fear during a behavioral avoidance task, the Claustrophobia Questionnaire, and the Claustrophobic Concerns Questionnaire. Results showed that both conditions improved significantly at post-treatment with no significant difference between groups. Consistent with prediction the group that took yohimbine hydrochloride prior to exposure sessions showed significantly greater improvement in peak fear at the one-week follow-up behavioral assessment (d=1.68). This was also true across other outcome measures with large to very large effect sizes. These data provide initial support for exposure enhancing effect of single-dose yohimbine hydrochloride in a clinical application.
Wei, Wei; Shary, Judith R; Garrett-Mayer, Elizabeth; Anderson, Betsy; Forestieri, Nina E; Hollis, Bruce W; Wagner, Carol L
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, pregnancy bone health. This trial was registered at clinicaltrials.gov as NCT00292591. © 2017 American Society for Nutrition.
Duncan, Amy; Zajac, Ian; Flight, Ingrid; Stewart, Benjamin J R; Wilson, Carlene; Turnbull, Deborah
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
Riis, Allan; Jensen, Cathrine Elgaard; Maindal, Helle Terkildsen
Introduction: Health service research often involves the active participation of healthcare professionals. However, their ability and commitment to research varies. This can cause recruitment difficulties and thereby prolong the study period and inflate budgets. Solberg has identified seven R-fac...
O'Connor, Elodie; Farrow, Maree; Hatherly, Chris
Encouraging middle-aged adults to maintain their physical and cognitive health may have a significant impact on reducing the prevalence of dementia in the future. Mobile phone apps and interactive websites may be one effective way to target this age group. However, to date there has been little research investigating the user experience of dementia risk reduction tools delivered in this way. The aim of this study was to explore participant engagement and evaluations of three different targeted smartphone and Web-based dementia risk reduction tools following a four-week intervention. Participants completed a Web-based screening questionnaire to collect eligibility information. Eligible participants were asked to complete a Web-based baseline questionnaire and were then randomly assigned to use one of the three dementia risk reduction tools for a period of four weeks: (1) a mobile phone application; (2) an information-based website; and (3) an interactive website. User evaluations were obtained via a Web-based follow-up questionnaire after completion of the intervention. Of 415 eligible participants, 370 (89.16%) completed the baseline questionnaire and were assigned to an intervention group; 200 (54.05%) completed the post-intervention questionnaire. The average age of participants was 52 years, and 149 (75%) were female. Findings indicated that participants from all three intervention groups reported a generally positive impression of the tools across a range of domains. Participants using the information-based website reported higher ratings of their overall impression of the tool, F2,191=4.12, P=.02; how interesting the information was, F2,189=3.53, P=.03; how helpful the information was, F2,192=4.15, P=.02; and how much they learned, F2,188=3.86, P=.02. Group differences were significant between the mobile phone app and information-based website users, but not between the interactive website users and the other two groups. Additionally, participants using the
Dounavi, Myrto D; Chesterton, Linda S; Sim, Julius
Little evidence exists regarding parameter selection for hypoalgesia using interferential therapy (IFT). This study investigated segmental and extrasegmental hypoalgesic effects of different IFT parameter combinations upon experimentally induced pressure pain threshold (PPT) in pain-free volunteers. The participants were randomly assigned to 6 groups: control, placebo, bipolar constant amplitude modulation frequency (AMF), bipolar sweep AMF, quadripolar constant AMF, and quadripolar sweep AMF. The study was conducted in a university laboratory. One hundred eighty adults who were healthy and pain-free participated in the study. Interferential therapy was delivered to all groups at high, to-tolerance intensity and at high AMF. Stimulation to the dominant forearm was delivered for 30 minutes, with monitoring for a further 30 minutes. Pain pressure threshold was measured at the area of first dorsal interosseous muscle of the dominant and nondominant hands (segmental measurements) and over the tibialis anterior muscle (extrasegmental measurement) at baseline and at 10-minute intervals using a pressure algometer. Square root transformed PPT data were analyzed using repeated-measures analysis of variance. There was a significant change in PPT over time, but no significant between-subjects difference in segmental or extrasegmental PPT between any of the IFT groups and the placebo or control group. Thus, IFT delivered in any of these parameter combinations did not significantly affect the PPT of pain-free participants compared with the control or placebo group. Success of blinding was not evaluated. This study showed that IFT delivered at high, to-tolerance intensity and high AMF does not produce significant segmental and extrasegmental hypoalgesic effects on PPT in participants who were healthy compared with a control or placebo group. Further research is warranted to investigate the hypoalgesic effect of different IFT parameter combinations and to explain its possible
Feasibility Study of a Randomized Controlled Trial of a Telephone-Delivered Problem Solving-Occupational Therapy Intervention to Reduce Participation Restrictions in Rural Breast Cancer Survivors Undergoing Chemotherapy
Hegel, Mark T.; Lyons, Kathleen D.; Hull, Jay G.; Kaufman, Peter; Urquhart, Laura; Li, Zhongze; Ahles, Tim A.
Objective Breast cancer patients receiving adjuvant chemotherapy often experience functional effects of treatment that limit participation in life activities. The purpose of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) of a novel intervention for these restrictions, determine acceptability of the intervention, and preliminarily assess its effects. Methods A pilot RCT of a telephone-delivered Problem Solving and Occupational Therapy intervention (PST-OT) to improve participation restrictions in rural breast cancer patients undergoing chemotherapy. Thirty-one participants with Stages 1-3 breast cancer were randomized to 6 weekly sessions of PST-OT (n=15) and Usual Care (n=16). The primary study outcome was the feasibility of conducting the trial. Secondary outcomes were functional, quality of life and emotional status as assessed at baseline, 6 weeks and 12 weeks. Results Of 46 patients referred 31 were enrolled (67% recruitment rate), of which 6 participants withdrew (81% retention rate). Twenty-four participants completed all study-related assessments (77%). Ninety-two percent of PST-OT participants were highly satisfied with the intervention, and 92% reported PST-OT to be helpful/very helpful for overcoming participation restrictions. Ninety-seven percent of planned PST-OT treatment sessions were completed. Completion rates for PST-OT homework tasks were high. Measures of functioning, quality of life and emotional state favored the PST-OT condition. Conclusion This pilot study suggests that an RCT of the PST-OT intervention is feasible to conduct with rural breast cancer patients undergoing adjuvant chemotherapy and that PST-OT may have positive effects on function, quality of life, and emotional state. PMID:20821373
Feasibility study of a randomized controlled trial of a telephone-delivered problem-solving-occupational therapy intervention to reduce participation restrictions in rural breast cancer survivors undergoing chemotherapy.
Hegel, Mark T; Lyons, Kathleen D; Hull, Jay G; Kaufman, Peter; Urquhart, Laura; Li, Zhongze; Ahles, Tim A
Breast cancer patients receiving adjuvant chemotherapy often experience functional effects of treatment that limit participation in life activities. The purpose of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) of a novel intervention for these restrictions, determine acceptability of the intervention, and preliminarily assess its effects. A pilot RCT of a telephone-delivered Problem-solving and Occupational Therapy intervention (PST-OT) to improve participation restrictions in rural breast cancer patients undergoing chemotherapy. Thirty-one participants with Stages 1-3 breast cancer were randomized to 6 weekly sessions of PST-OT (n = 15) and usual care (n = 16). The primary study outcome was the feasibility of conducting the trial. Secondary outcomes were functional, quality of life and emotional status as assessed at baseline, 6 and 12 weeks. Of 46 patients referred 31 were enrolled (67% recruitment rate), of which 6 participants withdrew (81% retention rate). Twenty-four participants completed all study-related assessments (77%). Ninety-two percent of PST-OT participants were highly satisfied with the intervention, and 92% reported PST-OT to be helpful/very helpful for overcoming participation restrictions. Ninety-seven percent of planned PST-OT treatment sessions were completed. Completion rates for PST-OT homework tasks were high. Measures of functioning, quality of life, and emotional state favored the PST-OT condition. This pilot study suggests that an RCT of the PST-OT intervention is feasible to conduct with rural breast cancer patients undergoing adjuvant chemotherapy and that PST-OT may have positive effects on function, quality of life, and emotional state. 2010 John Wiley & Sons, Ltd.
Vass, Mikkel; Avlund, Kirsten; Hendriksen, Carsten
a significantly higher mortality rate and risk of admission to nursing home than participants, whereas the subgroups of non-participants describing themselves as "too healthy" and having "another reason for refusal" did not differ from the participants. There was no difference in mortality rates between non...
Crane, Melissa M; Tate, Deborah F; Finkelstein, Eric A; Linnan, Laura A
This analysis investigated if changes in autonomous or controlled motivation for participation in a weight loss program differed between individuals offered a financial incentive for weight loss compared to individuals not offered an incentive. Additionally, the same relationships were tested among those who lost weight and either received or did not receive an incentive. This analysis used data from a year-long randomized worksite weight loss program that randomly assigned employees in each worksite to either a low-intensity weight loss program or the same program plus small financial incentives for weight loss ($5.00 per percentage of initial weight lost). There were no differences in changes between groups on motivation during the study, however, increases in autonomous motivation were consistently associated with greater weight losses. This suggests that the small incentives used in this program did not lead to increases in controlled motivation nor did they undermine autonomous motivation. Future studies are needed to evaluate the magnitude and timing of incentives to more fully understand the relationship between incentives and motivation.
Melissa M. Crane
Full Text Available This analysis investigated if changes in autonomous or controlled motivation for participation in a weight loss program differed between individuals offered a financial incentive for weight loss compared to individuals not offered an incentive. Additionally, the same relationships were tested among those who lost weight and either received or did not receive an incentive. This analysis used data from a year-long randomized worksite weight loss program that randomly assigned employees in each worksite to either a low-intensity weight loss program or the same program plus small financial incentives for weight loss ($5.00 per percentage of initial weight lost. There were no differences in changes between groups on motivation during the study, however, increases in autonomous motivation were consistently associated with greater weight losses. This suggests that the small incentives used in this program did not lead to increases in controlled motivation nor did they undermine autonomous motivation. Future studies are needed to evaluate the magnitude and timing of incentives to more fully understand the relationship between incentives and motivation.
Crane, Melissa M.; Tate, Deborah F.; Finkelstein, Eric A.; Linnan, Laura A.
This analysis investigated if changes in autonomous or controlled motivation for participation in a weight loss program differed between individuals offered a financial incentive for weight loss compared to individuals not offered an incentive. Additionally, the same relationships were tested among those who lost weight and either received or did not receive an incentive. This analysis used data from a year-long randomized worksite weight loss program that randomly assigned employees in each worksite to either a low-intensity weight loss program or the same program plus small financial incentives for weight loss ($5.00 per percentage of initial weight lost). There were no differences in changes between groups on motivation during the study, however, increases in autonomous motivation were consistently associated with greater weight losses. This suggests that the small incentives used in this program did not lead to increases in controlled motivation nor did they undermine autonomous motivation. Future studies are needed to evaluate the magnitude and timing of incentives to more fully understand the relationship between incentives and motivation. PMID:22577524
Hansen, Baiba; Hanash, Jamal A.; Rasmussen, Alice
Background: The prevalence of depression and anxiety in patients after acute coronary syndrome (ACS) is higher than in the general population. In a study on prevention of post-ACS depression, more than half of eligible patients declined participation. Aims: The aim of this study was to evaluate...... whether symptoms of depression and anxiety in participants and non-participants predicted participation in the study. Methods: This substudy was conducted between May 2005 and April 2007. Patients with ACS, eligible for the study (n=302) were asked four questions on depression and anxiety from the Primary...... (43.9%) participants and 55 (44%) non-participants were screened positive for anxiety (NS). Non-participants were older (P=0.002), while no significant differences in gender or cardiac diagnosis were found. Conclusions: Symptoms of depression and anxiety were highly prevalent in patients after ACS...
The Patient Deficit Model Overturned: a qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011
Full Text Available Abstract Background Evidence suggests that poor recruitment into clinical trials rests on a patient ‘deficit’ model – an inability to comprehend trial processes. Poor communication has also been cited as a possible barrier to recruitment. A qualitative patient interview study was included within the feasibility stage of a phase III non-inferiority Randomized Controlled Trial (RCT (SPARE, CRUK/07/011 in muscle invasive bladder cancer. The aim was to illuminate problems in the context of randomization. Methods The qualitative study used a ‘Framework Analysis’ that included ‘constant comparison’ in which semi-structured interviews are transcribed, analyzed, compared and contrasted both between and within transcripts. Three researchers coded and interpreted data. Results Twenty-four patients agreed to enter the interview study; 10 decliners of randomization and 14 accepters, of whom 2 subsequently declined their allocated treatment. The main theme applying to the majority of the sample was confusion and ambiguity. There was little indication that confusion directly impacted on decisions to enter the SPARE trial. However, confusion did appear to impact on ethical considerations surrounding ‘informed consent’, as well as cause a sense of alienation between patients and health personnel. Sub-optimal communication in many guises accounted for the confusion, together with the logistical elements of a trial that involved treatment options delivered in a number of geographical locations. Conclusions These data highlight the difficulty of providing balanced and clear trial information within the UK health system, despite best intentions. Involvement of multiple professionals can impact on communication processes with patients who are considering participation in RCTs. Our results led us to question the ‘deficit’ model of patient behavior. It is suggested that health professionals might consider facilitating a context in which patients
Mudge, Anita; Harvey, Lisa A; Lancaster, Ann; Lowe, Kevin
To determine whether electrical stimulation (ES) following botulinum toxin A (BoNT/A) injection increases passive extensibility of the hamstring muscles in children with spastic diplegia. Six children undergoing bilateral BoNT/A injections to the hamstrings participated in this within-participant single blind randomized controlled trial. One leg of each child was randomised to the experimental condition and the other to the control condition. The experimental leg received daily stretch and ES to the hamstrings for 12 weeks, while the control leg received only daily stretch. The primary outcome was passive hamstring extensibility reflected by popliteal angle measured with a standardised torque. Secondary outcomes were two goniometric measures of popliteal angle using the Modified Tardieu Scale (R1 and R2), and parents' perceptions of treatment effectiveness. Outcomes were measured at baseline, 4 weeks, 12 weeks and 6 months. The mean between-group difference (95% CI) at 4 weeks was 2° (-2 to 5) for popliteal angle measured with a standardised torque, favouring the experimental leg. Tardieu results for R1 and R2 were 0° (-4 to 3) and 7° (0 to 14), respectively. ES does not improve passive extensibility of the hamstring muscles at 4 weeks over any possible effects of BoNT/A alone.
Dai, Chin-Ying; Huang, Yu-Hui; Chou, Li-Wei; Wu, Shiao-Chi; Wang, Ray-Yau; Lin, Li-Chan
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. 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. 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 at days 14 and 28 in the areas of neglect, ADL, and balance. No significant difference was observed between the two groups in the number of falls. Neglect, ADL, and balance among UN patients with right hemispheric stroke can be improved through the participation of primary caregivers in VR. Trained informal caregivers were recommended to provide VR guidance and supervision to patients who suffer from UN.
Williams, Ishan C; Utz, Sharon W; Jones, Randy; Hinton, Ivora; Steeves, Richard; Alexander, Gina
Recruiting rural African Americans for research presents special problems because of cultural differences, the view of researchers as cultural "outsiders", and transportation problems. This paper reports successful strategies in recruiting rural African American adults with type 2 diabetes for research studies. The researchers tested recruitment strategies commonly used in research, such as flyers, advertisements in local newspapers and radio stations. The researchers also encouraged referrals from medical professionals. When recruitment goals were not met, the researchers modified strategies. Twenty-two rural African American participants were recruited and randomly assigned to culturally-tailored Group or Individual Diabetes Self Management Education (DSME). The latter included storytelling and an interactive learning approach. The key recruitment strategies involved spending time in the community, visits to churches, and flyers to key leaders in the Black community. Enrolling rural African Americans required cultural competence, careful planning, and time in the community. Recruiting for clinical research is challenging and more difficult when targeting minority members in rural settings. Research in diabetes care is needed with rural African Americans because of high rates of diabetes, and limited health care access for this population. Effective recruitment and retention strategies are needed to test interventions to reduce health disparities.
The Minnesota Green Tea Trial (MGTT), a randomized controlled trial of the efficacy of green tea extract on biomarkers of breast cancer risk: study rationale, design, methods, and participant characteristics.
Samavat, Hamed; Dostal, Allison M; Wang, Renwei; Bedell, Sarah; Emory, Tim H; Ursin, Giske; Torkelson, Carolyn J; Gross, Myron D; Le, Chap T; Yu, Mimi C; Yang, Chung S; Yee, Douglas; Wu, Anna H; Yuan, Jian-Min; Kurzer, Mindy S
The Minnesota Green Tea Trial (MGTT) was a randomized, placebo-controlled, double-blinded trial investigating the effect of daily green tea extract consumption for 12 months on biomarkers of breast cancer risk. Participants were healthy postmenopausal women at high risk of breast cancer due to dense breast tissue with differing catechol-O-methyltransferase (COMT) genotypes. The intervention was a green tea catechin extract containing 843.0 ± 44.0 mg/day epigallocatechin gallate or placebo capsules for 1 year. Annual digital screening mammograms were obtained at baseline and month 12, and fasting blood and 24-h urine samples were provided at baseline and at months 6 and 12. Primary endpoints included changes in percent mammographic density, circulating endogenous sex hormones, and insulin-like growth factor axis proteins; secondary endpoints were changes in urinary estrogens and estrogen metabolites and circulating F2-isoprostanes, a biomarker of oxidative stress. The MGTT screened more than 100,000 mammograms and randomized 1,075 participants based on treatment (green tea extract vs. placebo), stratified by COMT genotype activity (high COMT vs. low/intermediate COMT genotype activity). A total of 937 women successfully completed the study and 138 dropped out (overall dropout rate = 12.8 %). In this paper we report the rationale, design, recruitment, participant characteristics, and methods for biomarker and statistical analyses.
Horowitz, Carol R; Brenner, Barbara L; Lachapelle, Susanne; Amara, Duna A; Arniella, Guedy
Traditional research approaches frequently fail to yield representative numbers of people of color in research. Community-based participatory research (CBPR) may be an important strategy for partnering with and reaching populations that bear a greater burden of illness but have been historically difficult to engage. The Community Action Board, consisting of 20 East Harlem residents, leaders, and advocates, used CBPR to compare the effectiveness of various strategies in recruiting and enrolling adults with prediabetes into a peer-led, diabetes prevention intervention. The board created five recruitment strategies: recruiting through clinicians; recruiting at large public events such as farmers markets; organizing special local recruitment events; recruiting at local organizations; and recruiting through a partner-led approach, in which community partners developed and managed the recruitment efforts at their sites. In 3 months, 555 local adults were approached; 249 were appropriate candidates for further evaluation (overweight, nonpregnant, East Harlem residents without known diabetes); 179 consented and returned in a fasting state for 1/2 day of prediabetes testing; 99 had prediabetes and enrolled in a pilot randomized trial. The partner-led approach was highly successful, recruiting 68% of those enrolled. This strategy was also the most efficient; 34% of those approached through partners were ultimately enrolled, versus 0%-17% enrolled through the other four strategies. Participants were predominantly low-income, uninsured, undereducated, Spanish-speaking women. This CBPR approach highlights the value of partner-led recruitment to identify, reach out to, and motivate a vulnerable population into participation in research, using techniques that may be unfamiliar to researchers but are nevertheless rigorous and effective.
Hansen, Baiba; Hanash, Jamal A.; Rasmussen, Alice
Background: The prevalence of depression and anxiety in patients after acute coronary syndrome (ACS) is higher than in the general population. In a study on prevention of post-ACS depression, more than half of eligible patients declined participation. Aims: The aim of this study was to evaluate...... (43.9%) participants and 55 (44%) non-participants were screened positive for anxiety (NS). Non-participants were older (P=0.002), while no significant differences in gender or cardiac diagnosis were found. Conclusions: Symptoms of depression and anxiety were highly prevalent in patients after ACS...
Kendzor, Darla E; Reitzel, Lorraine R; Mazas, Carlos A; Cofta-Woerpel, Ludmila M; Cao, Yumei; Ji, Lingyun; Costello, Tracy J; Vidrine, Jennifer Irvin; Businelle, Michael S; Li, Yisheng; Castro, Yessenia; Ahluwalia, Jasjit S; Cinciripini, Paul M; Wetter, David W
African Americans suffer disproportionately from the adverse health consequences of smoking, and also report substantially lower socioeconomic status than Whites and other racial/ethnic groups in the U.S. Although socioeconomic disadvantage is known to have a negative influence on smoking cessation rates and overall health, little is known about the influence of socioeconomic status on smoking cessation specifically among African Americans. Thus, the purpose of the current study was to characterize the impact of several individual- and area-level indicators of socioeconomic status on smoking cessation among African Americans. Data were collected as part of a smoking cessation intervention study for African American smokers (N = 379) recruited from the Houston, Texas, metropolitan area, who participated in the study between 2005 and 2007. The separate and combined influences of individual-level (insurance status, unemployment, education, and income) and area-level (neighborhood unemployment, education, income, and poverty) indicators of socioeconomic status on continuous smoking abstinence were examined across time intervals using continuation ratio logit modeling. Individual-level analyses indicated that unemployment was significantly associated with reduced odds of smoking abstinence, while higher income was associated with greater odds of abstinence. However, only unemployment remained a significant predictor of abstinence when unemployment and income were included in the model together. Area-level analyses indicated that greater neighborhood unemployment and poverty were associated with reduced odds of smoking abstinence, while greater neighborhood education was associated with higher odds of abstinence. However, only neighborhood unemployment remained significantly associated with abstinence status when individual-level income and unemployment were included in the model. Overall, findings suggest that individual- and area-level unemployment have a negative
Kathryn Ann Kaiser
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
Kaiser, Kathryn Ann; Affuso, Olivia; Desmond, Renee; Allison, David B.
Introduction: Understanding participant demographic characteristics that inform the optimal design of obesity randomized controlled trials (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 RCTs 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 DORs, or otherwise adjust a priori power estimates. Understanding true reasons for dropout may require additional methods of data gathering not generally employed in obesity
Brindal, Emily; Freyne, Jill; Saunders, Ian; Berkovsky, Shlomo; Smith, Greg; Noakes, Manny
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
Freyne, Jill; Saunders, Ian; Berkovsky, Shlomo; Smith, Greg; Noakes, Manny
Background 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. Objective 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. Methods 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. Results 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
Tilbrook, Helen E; Becque, Taeko; Buckley, Hannah; MacPherson, Hugh; Bailey, Mathew; Torgerson, David J
Attrition is a threat to the validity of randomized trials. Few randomized studies have been conducted within randomized trials to test methods of reducing attrition. To test whether using yellow post-it notes on follow-up questionnaires in the ATLAS treatment trial for neck pain reduces attrition. Nested trial within a trial. ATLAS participants were randomized to have their 6-month follow-up questionnaire have a 3' yellow post-it note with a handwritten message encouraging return of questionnaire. 499 participants were independently randomized using simple allocation to receive the post-it notes or not. Two hundred fifteen of the 256 (84.0%) participants in the intervention group returned their questionnaire compared with 205 of the 243 (84.4%) in the control group. There was no difference in time to response. Yellow post-it notes do not enhance questionnaire return rates for participants in a randomized trial of neck pain. © 2014 John Wiley & Sons, Ltd.
Vento, Giovanni; Pastorino, Roberta; Boni, Luca; Cota, Francesco; Carnielli, Virgilio; Cools, Filip; Dani, Carlo; Mosca, Fabio; Pillow, Jane; Polglase, Graeme; Tagliabue, Paolo; van Kaam, Anton H; Ventura, Maria Luisa; Tana, Milena; Tirone, Chiara; Aurilia, Claudia; Lio, Alessandra; Ricci, Cinzia; Gambacorta, Alessandro; Consigli, Chiara; D'Onofrio, Danila; Gizzi, Camilla; Massenzi, Luca; Cardilli, Viviana; Casati, Alessandra; Bottino, Roberto; Pontiggia, Federica; Ciarmoli, Elena; Martinelli, Stefano; Ilardi, Laura; Colnaghi, Mariarosa; Matassa, Piero Giuseppe; Vendettuoli, Valentina; Villani, Paolo; Fusco, Francesca; Gazzolo, Diego; Ricotti, Alberto; Ferrero, Federica; Stasi, Ilaria; Magaldi, Rosario; Maffei, Gianfranco; Presta, Giuseppe; Perniola, Roberto; Messina, Francesco; Montesano, Giovanna; Poggi, Chiara; Giordano, Lucio; Roma, Enza; Grassia, Carolina; Ausanio, Gaetano; Sandri, Fabrizio; Mescoli, Giovanna; Giura, Francesco; Garani, Giampaolo; Solinas, Agostina; Lucente, Maria; Nigro, Gabriella; Del Vecchio, Antonello; Petrillo, Flavia; Orfeo, Luigi; Grappone, Lidia; Quartulli, Lorenzo; Scorrano, Antonio; Messner, Hubert; Staffler, Alex; Gargano, Giancarlo; Balestri, Eleonora; Nobile, Stefano; Cacace, Caterina; Meli, Valerio; Dallaglio, Sara; Pasqua, Betta; Mattia, Loretta; Gitto, Eloisa; Vitaliti, Marcello; Re, Maria Paola; Vedovato, Stefania; Grison, Alessandra; Berardi, Alberto; Torcetta, Francesco; Guidotti, Isotta; di Fabio, Sandra; Maranella, Eugenia; Mondello, Isabella; Visentin, Stefano; Tormena, Francesca
Although beneficial in clinical practice, the INtubate-SURfactant-Extubate (IN-SUR-E) method is not successful in all preterm neonates with respiratory distress syndrome, with a reported failure rate ranging from 19 to 69 %. One of the possible mechanisms responsible for the unsuccessful IN-SUR-E method, requiring subsequent re-intubation and mechanical ventilation, is the inability of the preterm lung to achieve and maintain an "optimal" functional residual capacity. The importance of lung recruitment before surfactant administration has been demonstrated in animal studies showing that recruitment leads to a more homogeneous surfactant distribution within the lungs. Therefore, the aim of this study is to compare the application of a recruitment maneuver using the high-frequency oscillatory ventilation (HFOV) modality just before the surfactant administration followed by rapid extubation (INtubate-RECruit-SURfactant-Extubate: IN-REC-SUR-E) with IN-SUR-E alone in spontaneously breathing preterm infants requiring nasal continuous positive airway pressure (nCPAP) as initial respiratory support and reaching pre-defined CPAP failure criteria. In this study, 206 spontaneously breathing infants born at 24(+0)-27(+6) weeks' gestation and failing nCPAP during the first 24 h of life, will be randomized to receive an HFOV recruitment maneuver (IN-REC-SUR-E) or no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation. The primary outcome is the need for mechanical ventilation within the first 3 days of life. Infants in both groups will be considered to have reached the primary outcome when they are not extubated within 30 min after surfactant administration or when they meet the nCPAP failure criteria after extubation. From all available data no definitive evidence exists about a positive effect of recruitment before surfactant instillation, but a rationale exists for testing the following hypothesis: a lung recruitment
Borroto-Escuela, Dasiel O; Corrales, Fidel; Narvaez, Manuel; Oflijan, Julia; Agnati, Luigi F; Palkovits, Miklós; Fuxe, Kjell
New findings show that neurotrophic and antidepressant effects of 5-HT in brain can, in part, be mediated by activation of the 5-HT1A receptor protomer in the hippocampal and raphe FGFR1-5-HT1A heteroreceptor complexes enhancing the FGFR1 signaling. The dynamic agonist modulation of the FGFR1-5-HT1A heteroreceptor complexes and their recruitment of β-arrestin is now determined in cellular models with focus on its impact on 5-HT1AR and FGFR1 homodimerization in the heteroreceptor complexes based on BRET(2) assays. The findings show that coagonist treatment with 8-OH-DPAT and FGF2 but not treatment with the 5-HT1A agonist alone markedly increases the BRETmax values and significantly reduces the BRET50 values of 5HT1A homodimerization. The effects of FGF2 or FGF20 with or without the 5-HT1A agonist were also studied on the FGFR1 homodimerization of the heteroreceptor complexes. FGF2 produced a marked and rapid increase in FGFR1 homodimerization which partially declined over a 10min period. Cotreatment with FGF2 and 5-HT1A agonist blocked this decline in FGFR1 homodimerization. Furthermore, FGF2 alone produced a small increase in the BRET(2) signal from the 5-HT1A-β-arrestin2 receptor-protein complex which was additive to the marked effect of 8-OH-DPAT alone. Taken together, the participation of 5-HT1A and FGFR1 homodimers and recruitment of β-arrestin2 was demonstrated in the FGFR1-5-HT1A heteroreceptor complexes upon agonist treatments. Copyright © 2013 Elsevier Inc. All rights reserved.
Ronco, Guglielmo; Segnan, Nereo; Giorgi-Rossi, Paolo; Zappa, Marco; Casadei, Gian Piero; Carozzi, Francesca; Dalla Palma, Paolo; Del Mistro, Annarosa; Folicaldi, Stefania; Gillio-Tos, Anna; Nardo, Gaetano; Naldoni, Carlo; Schincaglia, Patrizia; Zorzi, Manuel; Confortini, Massimo; Cuzick, Jack
...), studies comparing conventional and liquid-based cytology have had conflicting results. In the first phase of a two-phase multicenter randomized controlled trial, women aged 35-60 years in the conventional arm (n = 16,658...
McCullough, Mary Beth; Janicke, David; Odar Stough, Cathleen; Robson, Shannon; Bolling, Christopher; Zion, Cindy; Stark, Lori
To compare the efficacy of opt-in versus opt-out recruitment methods in pediatric weight management clinical trials. Recruitment of preschoolers and school-age children across two obesity randomized controlled trials (RCTs) were compared using the same opt-in recruitment approach (parents contact researchers in response to mailings). Opt-in and opt-out strategies (parents send decline postcard in response to mailings if they do not want to participate) were then compared across two preschool obesity RCTs. Opt-in strategies yielded a significantly lower overall recruitment rate among preschoolers compared with school-age children. Among preschoolers, an opt-out strategy demonstrated a significantly higher overall recruitment rate compared with an opt-in strategy with the main advantage in the number of families initially contacted. Opt-out recruitment strategies may be more effective in overcoming the barriers of recruitment in the preschool age-group because it does not rely on parent recognition of obesity.
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
Morgan, Amy Joanna; Jorm, Anthony Francis; Mackinnon, Andrew James
.... Internet-based recruitment is becoming an increasingly important mode of recruitment, yet there are few detailed accounts of experiences recruiting participants to mental health interventions. Objective...
Heiney, Sue P; Adams, Swann Arp; Wells, Linda M; Johnson, Hiluv
To describe the Heiney-Adams Recruitment Framework (H-ARF); to delineate a recruitment plan for a randomized, behavioral trial (RBT) based on H-ARF; and to provide evaluation data on its implementation. All data for this investigation originated from a recruitment database created for an RBT designed to test the effectiveness of a therapeutic group convened via teleconference for African American women with breast cancer. Major H-ARF concepts include social marketing and relationship building. The majority of social marketing strategies yielded 100% participant recruitment. Greater absolute numbers were recruited via Health Insurance Portability and Accountability Act waivers. Using H-ARF yielded a high recruitment rate (66%). Application of H-ARF led to successful recruitment in an RBT. The findings highlight three areas that researchers should consider when devising recruitment plans: absolute numbers versus recruitment rate, cost, and efficiency with institutional review board-approved access to protected health information. H-ARF may be applied to any clinical or population-based research setting because it provides direction for researchers to develop a recruitment plan based on the target audience and cultural attributes that may hinder or help recruitment.
Murdoch, Maureen; Simon, Alisha Baines; Polusny, Melissa Anderson; Bangerter, Ann Kay; Grill, Joseph Patrick; Noorbaloochi, Siamak; Partin, Melissa Ruth
, disclosure of sensitive or stigmatizing information under differing privacy conditions may have less to do with promoting or impeding participants' "honesty" or "accuracy" than with selectively recruiting or attracting subpopulations that are higher or lower in such experiences. Pre-merged questionnaires bypassed many historical limitations of anonymous surveys and hold promise for exploring non-response issues in future research.
Carlene J. Wilson
Full Text Available Abstract Background Common disease risk clusters in families due to shared genetics, exposure to environmental risk factors, and because many health behaviours are established and maintained in family environments. This randomised controlled trial will test whether the provision of a family health history (FHH risk assessment tool increases intentions and engagement in health behaviors. Message distribution and collective behavior change within family networks will be mapped using social network analysis. The relative intervention impact will be compared between families from different ethnic backgrounds. Methods One hundred and fifty mothers (50 Anglo-Australian, 50 Italian-Australian, 50 Vietnamese-Australian will be recruited, with four or more other family members across three generations, including a child (aged 10–18 years. Each family is randomly assigned to intervention or control. At baseline and 6-month follow-up, all participants complete surveys to assess dietary and physical activity intentions and behaviors, attitudes towards food, and perceived disease risk. Intervention families receive a visual pedigree detailing their FHH of diabetes, heart disease, breast and bowel cancer, a health education workbook to ascertain members’ disease risk (i.e. average or above average risk, and screening and primary prevention recommendations. After completion of follow-up assessments, controls will receive their pedigree and workbook. The primary hypothesis is that attitudes and lifestyle behaviors will improve more within families exposed to FHH feedback, although the extent of this improvement may vary between families from different ethnic backgrounds. Additionally, the extent of improvement in the treatment group will be moderated by the level of family disease risk, with above-average risk leading to greater improvement. A secondary aim will explore different family members’ roles in message distribution and collective responses to
Heffner, Jaimee L; Wyszynski, Christopher M; Comstock, Bryan; Mercer, Laina D; Bricker, Jonathan
Web-based behavioral interventions for substance use are being developed at a rapid pace, yet there is a dearth of information regarding the most effective methods for recruiting participants into web-based intervention trials. In this paper, we describe our successful recruitment of participants into a pilot trial of web-based Acceptance and Commitment Therapy (ACT) for smoking cessation and compare traditional and web-based methods of recruitment in terms of their effects on baseline participant characteristics, association with study retention and treatment outcome, yield, and cost-effectiveness. Over a 10-week period starting June 15, 2010, we recruited 222 smokers for a web-based smoking cessation study using a variety of recruitment methods. The largest portion of randomized participants were recruited through Google AdWords (36%), followed by medical Internet media (23%), standard media (14%), word of mouth (12%), broadcast emails (11%), and social media (6%). Recruitment source was not related to baseline participant characteristics, 3-month data retention, or 30-day point prevalence smoking abstinence at the 3-month outcome assessment. Cost per randomized participant ranged from $5.27/participant for word of mouth to $172.76/participant for social media, with a mean cost of $42.48/participant. Our diversified approach to recruitment, including both traditional and web-based methods, enabled timely enrollment of participants into the study. Because there was no evidence of a substantive difference in baseline characteristics, retention, or outcomes based on recruitment channel, the yield and cost-effectiveness of recruitment methods may be the more critical considerations in developing a feasible recruitment plan for a web-based smoking cessation intervention study. Copyright © 2013 Elsevier Ltd. All rights reserved.
Laura E. Slosky
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.
de Bot, Cindy M. A.; Moed, Heleen; Berger, Marjolein Y.; Roder, Esther; de Groot, Hans; de Jongste, Johan C.; van Wijk, Roy Gerth; van der Wouden, Johannes C.
Background: For respiratory allergic disorders in children, sublingual immunotherapy has been developed as an alternative to subcutaneous immunotherapy. Sublingual immunotherapy is more convenient, has a good safety profile and might be an attractive option for use in primary care. A randomized
Effective human resources management has been identified as one of four critical success factors in the Department of Energy Strategic Plan. The Plan states relative to this factor: ``The Department seeks greater alignment of resources with agency priorities and increased diversification of the workforce, including gender, ethnicity, age, and skills. This diversification will bring new thinking and perspectives that heretofore have not had a voice in departmental decision-making.`` This Guide has been developed as a key tool to assist Department of Energy management and administrative staff in achieving Goal 2 of this critical success factor, which is to ``Ensure a diverse and talented workforce.`` There are numerous sources from which to recruit minorities, women and persons with disabilities. Applying creativity and proactive effort, using traditional and non-traditional approaches, and reaching out to various professional, academic and social communities will increase the reservoir of qualified candidates from which to make selections. In addition, outreach initiatives will undoubtedly yield further benefits such as a richer cultural understanding and diversity awareness. The resource listings presented in this Guide are offered to encourage active participation in the diversity recruitment process. This Guide contains resource listings by state for organizations in the following categories: (1) African American Recruitment Sources; (2) Asian American/Pacific Islander Recruitment Sources; (3) Hispanic Recruitment Sources; (4) Native American/Alaskan Native Recruitment Sources; (5) Persons with Disabilities Recruitment Sources; and (6) Women Recruitment Sources.
VARIATIONS IN RECRUITMENT YIELD, COSTS, SPEED AND PARTICIPANT DIVERSITY ACROSS INTERNET PLATFORMS IN A GLOBAL STUDY EXAMINING THE EFFICACY OF AN HIV/AIDS AND HIV TESTING ANIMATED AND LIVE-ACTION VIDEO AMONG ENGLISH- OR SPANISH-SPEAKING INTERNET OR SOCIAL MEDIA USERS.
Shao, Winnie; Guan, Wentao; Clark, Melissa A; Liu, Tao; Santelices, Claudia; Cortés, Dharma E; Merchant, Roland C
For a world-wide, Internet-based study on HIV/AIDS and HIV testing knowledge, we compared the yields, speed and costs of recruitment and participant diversity across free postings on 13 Internet or social media platforms, paid advertising or postings on 3 platforms, and separate free postings and paid advertisements on Facebook. Platforms were compared by study completions (yield), time to completion, completion to enrollment ratios (CERs), and costs/ completion; and by participants' demographic characteristics, HIV testing history, and health literacy levels. Of the 482 English-speaking participants, Amazon Mechanical Turk yielded the most participants, recruited participants at the fastest rate and had the highest CER (0.78) and lowest costs / completion. Of the 335 Spanish-speaking participants, Facebook yielded the most participants and recruited participants at the fastest rate, although Amazon Mechanical Turk had the highest CER (0.72) and lowest costs/completion. Across platforms participants differed substantially according to their demographic characteristics, HIV testing history and health literay skills. The study results highlight the need for researchers to strongly consider choice of Internet or social media plaforms when conducting Internet-based research. Because of the sample specifications and cost restraints of studies, specific Internet/ social media or participant selection plaforms will be much more effective or appropriate than others.
Maloney, Cristine; Lyons, Kathleen Doyle; Li, Zhongze; Hegel, Mark; Ahles, Tim A; Bakitas, Marie
ENABLE (Educate, Nurture, Advise Before Life Ends) II was one of the first randomized controlled trials (RCTs) examining the effects of a concurrent oncology palliative care intervention on quality of life, mood, and symptom control for advanced cancer patients and their caregivers. However, little is known about how participants experience early palliative care and the benefits and burdens of participating in a palliative care clinical trial. To gain a deeper understanding of participants' perspectives of the intervention and palliative care trial participation. A qualitative descriptive study using thematic analysis to determine benefits and burdens of a new palliative care intervention and trial participation. Of the 72 participants who were alive when the study commenced, 53 agreed to complete an in-depth, semi-structured interview regarding the ENABLE II intervention and clinical trial participation. Participants' perceptions of intervention benefits were represented by four themes: enhanced problem-solving skills, better coping, feeling empowered, and feeling supported or reassured. Three themes related to trial participation: helping future patients and contributing to science, gaining insight through completion of questionnaires, and trial/intervention aspects to improve. The benefits of the intervention and the positive aspects of trial participation outweighed trial "burdens". This study raises additional important questions relevant to future trial design and intervention development: when should a palliative care intervention be initiated and what aspects of self-care and healthy living should be offered in addition to palliative content for advanced cancer patients when they are feeling well?
Powers, M.B.; Smits, J.A.J.; Otto, M.W.; Sanders, C.; Emmelkamp, P.M.G.
Preliminary animal research suggests that yohimbine hydrochloride, a selective competitive alpha2-adrenergic receptor antagonist, accelerates fear extinction and converts ineffective extinction regimens (long intertrial intervals) to effective ones. This randomized placebo controlled study examined
Powers, M.B.; Smits, J.A.J.; Otto, M.W.; Sanders, C.; Emmelkamp, P.M.G.
Preliminary animal research suggests that yohimbine hydrochloride, a selective competitive alpha2-adrenergic receptor antagonist, accelerates fear extinction and converts ineffective extinction regimens (long intertrial intervals) to effective ones. This randomized placebo controlled study examined
LeBlanc, Thomas W; Lodato, Jordan E; Currow, David C; Abernethy, Amy P
Palliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research-especially participant recruitment-is difficult. Major barriers include (1) patient factors, (2) "gatekeeping," and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study. The PCT was a 2 × 2 × 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of "social marketing," an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications. From an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%). Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing-based protocol shows the benefits of such an approach.
Variations in recruitment yield, costs, speed and participant diversity across Internet platforms in a global study examining the efficacy of an HIV/AIDS and HIV testing animated and live-action video among English- or Spanish-speaking Internet or social media users
Full Text Available For a world-wide, Internet-based study on HIV/AIDS and HIV testing knowledge, we compared the yields, speed and costs of recruitment and participant diversity across free postings on 13 Internet or social media platforms, paid advertising or postings on 3 platforms, and separate free postings and paid advertisements on Facebook. Platforms were compared by study completions (yield, time to completion, completion to enrollment ratios (CERs, and costs/completion; and by participants’ demographic characteristics, HIV testing history, and health literacy levels. Of the 482 English-speaking participants, Amazon Mechanical Turk yielded the most participants, recruited participants at the fastest rate and had the highest CER (0.78 and lowest costs/completion. Of the 335 Spanish-speaking participants, Facebook yielded the most participants and recruited participants at the fastest rate, although Amazon Mechanical Turk had the highest CER (0.72 and lowest costs/completion. Across platforms participants differed substantially according to their demographic characteristics, HIV testing history and health literacy skills. The study results highlight the need for researchers to strongly consider choice of Internet or social media platforms when conducting Internet-based research. Because of the sample specifications and cost restraints of studies, specific Internet/social media or participant selection platforms will be much more effective or appropriate than others.
Rise, Marit B; Steinsbekk, Aslak
Governments in several countries attempt to strengthen user participation through instructing health-care organizations to implement user participation initiatives. There is, however, little knowledge on the effect on patients' experience from comprehensive plans for enhancing user participation in whole health service organizations. To investigate whether implementing a development plan intending to enhance user participation in a mental hospital had any effect on the patients' experience of user participation. A non-randomized controlled study including patients in three mental hospitals in Central Norway, one intervention hospital and two control hospitals. A development plan intended to enhance user participation was implemented in the intervention hospital as a part of a larger reorganizational process. The plan included establishment of a patient education centre and a user office, purchase of user expertise, appointment of contact professionals for next of kin and improvement of the centre's information and the professional culture. Perceptions of Care, Inpatient Treatment Alliance Scale and questions made for this study. A total of 1651 patients participated. Implementing a development plan in a mental hospital intending to enhance user participation had no significant effect on the patients' experience of user participation. The lack of effect can be due to inappropriate initiatives or challenges in implementation processes. Further research should ensure that initiatives and implementation processes are appropriate to impact the patients' experience. © 2013 John Wiley & Sons Ltd.
Young, Alys; Gomersall, Timothy; Bowen, Audrey
To explore trial participants' experiences of the process and outcomes of early, enhanced speech and language therapy after stroke with support from an employed visitor. Qualitative study nested within a randomized controlled trial. Twney-two people who, after stroke, had a diagnosis of aphasia (12), dysarthria (5) or both (5) and who participated in the ACT NoW study. Eight English NHS usual care settings. Individual interviews. Thematic content analysis assisted by a bespoke data transformation protocol for incorporating non-verbal and semantically ambiguous data. Participants highly regarded regular and sustained contact with someone outside of immediate family/friends who engaged them in deliberate activities/communication in the early months after stroke. Participants identified differences in the process of intervention between speech and language therapists and employed visitors. But no major discriminations were made between the impact or value of this contact according to whether provided by a speech and language therapist or employed visitor. Participant-defined criteria for effectiveness of contact included: impact on mood and confidence, self-recognition of progress and the meeting of individual needs. As in the randomized controlled trial, participants reported no evidence of added benefit of early communication therapy beyond that from attention control. The findings do not imply that regular contact with any non-professional can have beneficial effects for someone with aphasia or dysarthria in the early weeks following a stroke. The study points to specific conditions that would have to be met for contact to have a positive effect.
Paramasivan, S; Rogers, C A; Welbourn, R; Byrne, J P; Salter, N; Mahon, D; Noble, H; Kelly, J; Mazza, G; Whybrow, P; Andrews, R C; Wilson, C; Blazeby, J M; Donovan, J L
Randomized controlled trials (RCTs) involving surgical procedures are challenging for recruitment and infrequent in the specialty of bariatrics. The pilot phase of the By-Band-Sleeve study (gastric bypass versus gastric band versus sleeve gastrectomy) provided the opportunity for an investigation of recruitment using a qualitative research integrated in trials (QuinteT) recruitment intervention (QRI). The QRI investigated recruitment in two centers in the pilot phase comparing bypass and banding, through the analysis of 12 in-depth staff interviews, 84 audio recordings of patient consultations, 19 non-participant observations of consultations and patient screening data. QRI findings were developed into a plan of action and fed back to centers to improve information provision and recruitment organization. Recruitment proved to be extremely difficult with only two patients recruited during the first 2 months. The pivotal issue in Center A was that an effective and established clinical service could not easily adapt to the needs of the RCT. There was little scope to present RCT details or ensure efficient eligibility assessment, and recruiters struggled to convey equipoise. Following presentation of QRI findings, recruitment in Center A increased from 9% in the first 2 months (2/22) to 40% (26/65) in the 4 months thereafter. Center B, commencing recruitment 3 months after Center A, learnt from the emerging issues in Center A and set up a special clinic for trial recruitment. The trial successfully completed pilot recruitment and progressed to the main phase across 11 centers. The QRI identified key issues that enabled the integration of the trial into the clinical setting. This contributed to successful recruitment in the By-Band-Sleeve trial-currently the largest in bariatric practice-and offers opportunities to optimize recruitment in other trials in bariatrics.
Freuler, Ashley C; Baranek, Grace T; Tashjian, Christene; Watson, Linda R; Crais, Elizabeth R; Turner-Brown, Lauren M
Despite the mounting evidence of efficacy of early intervention for children with autism spectrum disorders, there is little research that considers the various perceptions and resources with which parents respond to the pressures and opportunities associated with participation in early intervention. Research is particularly lacking surrounding experiences of parents with infants who are at risk of autism spectrum disorders but do not (yet) have a diagnosed condition. This qualitative study aimed to explore the experiences of caregivers following their participation in a randomized controlled trial of Adapted Responsive Teaching, a parent-infant relationship-focused intervention for infants at risk of autism spectrum disorders in a community sample. Parents were randomized into either the treatment group, in which they participated in the Adapted Responsive Teaching intervention, or the community services group, in which they were provided with information regarding local early intervention services and were encouraged, but not required to, seek community services as part of their inclusion in the randomized controlled trial. Semistructured interviews were conducted with families following the completion of the randomized controlled trial. Participants consisted of 13 mothers and 4 fathers. Five dyads were interviewed together for a total of 14 families. Child ages ranged from 39 to 46 months at the time of interview. Analysis was conducted on 14 interviews from 10 families who were randomized into the treatment group and 4 families randomized into the community services group. Analysis was informed by a thematic analysis approach, which involved a systematic process of coding and theme identification both across and within groups. Themes that emerged across groups included Working against all odds, Value of the personal relationship, Getting the ball rolling, and Getting dad on board. One broad theme represented the data within the groups: Win-win (Adapted
Mueller, Christoph Emanuel; Gaus, Hansjoerg
In this article, we test an alternative approach to creating a counterfactual basis for estimating individual and average treatment effects. Instead of using control/comparison groups or before-measures, the so-called Counterfactual as Self-Estimated by Program Participants (CSEPP) relies on program participants' self-estimations of their own…
A novel use of the Spine Tango registry to evaluate selection bias in patient recruitment into clinical studies: an analysis of patients participating in the Lumbar Spinal Stenosis Outcome Study (LSOS).
Becker, H-J; Nauer, S; Porchet, F; Kleinstück, F S; Haschtmann, D; Fekete, T F; Steurer, J; Mannion, A F
Patients enrolled in clinical studies typically represent a sub-set of all who are eligible, and selection bias may compromise the generalizability of the findings. Using Registry data, we evaluated whether surgical patients recruited by one of the referring centres into the Lumbar Spinal Stenosis Outcome Study (LSOS; a large-scale, multicentre prospective observational study to determine the probability of clinical benefit after surgery) differed in any significant way from those who were eligible but not enrolled. Data were extracted for all patients with lumbar spinal stenosis registered in our in-house database (interfaced to Eurospine's Spine Tango Registry) from 2011 to 2013. Patient records and imaging were evaluated in relation to the admission criteria for LSOS to identify those who would have been eligible for participation but were not enrolled (non-LSOS). The Tango surgery data and Core Outcome Measures Index (COMI) data at baseline and 3 and 12 months after surgery were analysed to evaluate the factors associated with LSOS enrolment or not. 514 potentially eligible patients were identified, of which 94 (18%) were enrolled into LSOS (range 2-48% for the 6 spine surgeons involved in recruiting patients) and 420 (82%) were not; the vast majority of the latter were due to non-referral to the study by the surgeon, with only 5% actually refusing participation. There was no significant difference in gender, age, BMI, smoking status, or ASA score between the two groups (p ≥ 0.18). Baseline COMI was significantly (p = 0.002) worse in the non-LSOS group (7.4 ± 1.9) than the LSOS group (6.7 ± 1.9). There were no significant group differences in any Tango surgery parameters (additional spine patholothegies, operation time, blood loss, complications, etc.) although significantly more patients in the non-LSOS group had a fusion procedure (38 vs 18% in LSOS; p = 0.0004). Postoperatively, neither the COMI nor its subdomain scores differed significantly
Winters-Stone, Kerri M; Lyons, Karen S; Nail, Lillian M; Beer, Tomasz M
Prostate cancer can threaten quality of life for the patient and his spouse and the quality of his marital relationship. The purpose of our study is to evaluate the effects of "Exercising Together" - a partnered strength training program for married couples coping with prostate cancer - on the physical and emotional health of prostate cancer survivors (PCS) and their spouses and on marital quality. We are conducting a 6-month randomized controlled trial with two groups: 1) Exercising Together - a progressive, supervised strength training program and 2) a usual care control condition. The primary aims of this exploratory study are to: 1) Determine the effect of partnered strength training on physical and emotional health (muscle strength, physical function, body composition and self-report physical and mental health) in PCS, 2) Determine the effect of partnered strength training on physical and emotional health in spouses and 3) Explore the effect of partnered strength training on marital quality (incongruence, communication, relationship quality, intimacy) of the PCS and spouse. Target accrual has been met in this study with 64 couples enrolled and randomized to exercise (n=32) or usual care (n=32) groups. This study is the first to examine the feasibility of this exercise format in both the chronically ill patient and spouse and explore benefits at the individual and couple level. Copyright © 2011 Elsevier Inc. All rights reserved.
Raviotta, Jonathan M; Nowalk, Mary Patricia; Lin, Chyongchiou Jeng; Huang, Hsin-Hui; Zimmerman, Richard K
College-age men were recruited using Facebook™ advertisements (ads), as well as traditional recruitment methods, for a randomized controlled trial to compare immunological responses to human papillomavirus vaccine administered in two dosing schedules. This study compares enrollees who were recruited through traditional recruitment methods versus social networking sites (SNSs), including Facebook. Potential participants were recruited using flyers posted on and off campus(es), and distributed at health fairs, classes, sporting, and other campus events; e-mails to students and student organizations; and print advertisements in student newspapers and on city buses. Facebook ads were displayed to users with specific age, geographic, and interest characteristics; ads were monitored daily to make adjustments to improve response. A total of 220 males, aged 18 to 25 years enrolled between October 2010 and May 2011. The majority of participants (51%) reported print advertisements as the method by which they first heard about the study, followed by personal contact (29%) and Facebook or other SNSs (20%). The likelihood of a SNS being the source by which the participant first heard about the study compared with traditional methods was increased if the participant reported (a) being homosexual or bisexual or (b) posting daily updates on SNSs. Facebook and other SNSs are a viable recruitment strategy for reaching potential clinical trial participants among groups who typically use social media to stay connected with their friends and hard-to-reach groups such as young men who self-identify as homosexual or bisexual. © The Author(s) 2014.
Geenen, Sarah; Powers, Laurie E; Phillips, Lee Ann; Nelson, May; McKenna, Jessica; Winges-Yanez, Nichole; Blanchette, Linda; Croskey, Adrienne; Dalton, Lawrence D; Salazar, Amy; Swank, Paul
The purpose of the study was to conduct a preliminary efficacy evaluation of the Better Futures model, which is focused on improving the postsecondary preparation and participation of youth in foster care with mental health challenges. Sixty-seven youth were randomized to either a control group that received typical services or an intervention group, which involved participation in a Summer Institute, individual peer coaching, and mentoring workshops. Findings indicate significant gains for the intervention group on measures of postsecondary participation, postsecondary and transition preparation, hope, self-determination, and mental health empowerment, as compared to the control group. Youth in the intervention group also showed positive trends in the areas of mental health recovery, quality of life, and high school completion. Implications for future research and practice are discussed, while emphasizing the capacities of youth in foster care with mental health conditions to successfully prepare for and participate fully in high education.
Hjorthøj, Carsten Rygaard; Orlovska, Sonja; Fohlmann, Allan
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...
Endogenous markers of two separate hypoxia response pathways (hypoxia inducible factor 2 alpha and carbonic anhydrase 9) are associated with radiotherapy failure in head and neck cancer patients recruited in the CHART randomized trial.
Koukourakis, Michael I; Bentzen, Søren M; Giatromanolaki, Alexandra; Wilson, George D; Daley, Frances M; Saunders, Michele I; Dische, Stanley; Sivridis, Efthimios; Harris, Adrian L
Randomized controlled trials have generally shown a benefit from accelerated radiotherapy in head and neck squamous cell carcinoma (HNSCC). However, the large randomized United Kingdom trial CHART (Continuous Hyperfractionated Accelerated Radiotherapy) failed to show a benefit of strongly accelerated over standard radiotherapy (RT) in 918 patients with HNSCC. In this study, we investigated the impact of tumor hypoxia on the outcome of HNSCC patients in the CHART trial. There are two distinct hypoxia inducible factors (HIFs) that control different gene response pathways and we assessed them both with endogenous markers of hypoxia, hypoxia inducible factor HIF-2 alpha (HIF-2) and carbonic anhydrase CA9, an indicator of HIF-1 alpha (HIF-1) function. Tissue from pre-RT biopsies performed in 198 of 918 patients recruited was analyzed for the immunohistochemical expression of HIF-2 and CA9. A significant association of high HIF2 and of high CA9 reactivity with poor locoregional control (P uni-directional hypothesis, that a benefit from randomization to CHART should be seen in the nonhypoxic tumors, was supported by the data (one-tailed P = .04). Expression of endogenous markers of hypoxia for the HIF-1 and HIF-2 pathway is strongly associated with radiotherapy failure. Using immunohistochemical methods it is possible to identify subgroups of HNSCC patients who are highly curable with radiotherapy, or who are excellent candidates for clinical trials on hypoxia-targeting drugs in two distinct pathways.
Gates, P E; Banks, D; Johnston, T E; Campbell, S R; Gaughan, J P; Ross, S A; Engsberg, J R; Tucker, C
A multi-site Randomized-Controlled Trial compared a home-based Supported Speed Treadmill Training Exercise Program (SSTTEP) with a strengthening exercise program in children with cerebral palsy (CP) on the following categories; Participation, quality of life (QOL), self-concept, goal attainment, and satisfaction. Twenty-six children with spastic cerebral palsy were assigned by site-based block randomization to the SSTTEP (n=14) or strengthening exercise (n=12) group. Both groups participated in a two week clinic-based induction period and continued the intervention at home for ten weeks. Data were collected at baseline, post-intervention (12 weeks), and follow-up (16 weeks). Assessments included the Canadian Occupational Performance Measure, Children's Assessment of Participation and Enjoyment Scale, Pediatric Quality of Life Cerebral Palsy Module, and Piers-Harris Children's Self-Concept Scale. Evaluators were blinded to group assignment at two sites. Satisfaction and performance on individual goals, participation, and parent-reported QOL improved in both groups with improvement maintained for four weeks post intervention. The hypothesis that the SSTTEP group would have better outcomes than the exercise group was not supported. However, both groups showed that children with CP can make gains in participation, individual goals, and satisfaction following a 12-week intensive exercise intervention, and these findings persisted for four weeks post intervention.
Brushøj, Christoffer; Larsen, Klaus; Albrecht-Beste, Elisabeth
BACKGROUND: It is unknown whether an exercise program can prevent overuse injuries in the lower extremity. An often encountered and important risk factor for the development of lower extremity overuse injuries is an abrupt increase in activity level. HYPOTHESIS: A preventive training program based...... on a literature review of intrinsic risk factors, and performed concurrent with an increase in physical activity, can reduce the incidence of overuse knee injuries and medial tibial stress syndrome, as well as increase running distance. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS......: A total of 1020 soldiers aged 20.9 years (range, 19-26 years) undergoing 3 months of basic military training consecutively enrolled from December 2004 to December 2005. The prevention program consisted of an exercise program of 15 minutes' duration 3 times a week, including 5 exercises for strength...
Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van
Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40
2013 saw the launch of the one-day training course "Selecting the best person for CERN". So far, 10 courses have taken place and over 100 participants have taken part in this interactive, hands on experience. The course has been met with much enthusiasm and positive feedback, with participants not only feeling better prepared and organised for the recruitment boards, but also equipped with concrete tools on how to prepare and conduct an effective selection interview. Following on from this success, further sessions are planned in 2014: we look forward to welcoming recruiting supervisors and board members who are likely to take part in a recruitment process, whether for LD or LD2IC, and who are interested in finding out more about how to get the most out of this important process! To enrol to this course, please follow this link: "Selecting the best person for CERN".
Halliday, Mark H; Ferreira, Paulo H; Hancock, Mark J; Clare, Helen A
To investigate if McKenzie exercises when applied to a cohort of patients with chronic LBP who have a directional preference demonstrate improved recruitment of the transversus abdominis compared to motor control exercises when measurements were assessed from ultrasound images. A randomized blinded trial with a 12-month follow-up. The Physiotherapy department of Concord Hospital a primary health care environment. 70-adults with greater than three-month history of LBP who have a directional preference. McKenzie techniques or motor control exercises for 12-sessions over eight weeks. Transversus abdominus thickness measured from real time ultrasound images, pain, global perceived effect and capacity to self-manage. This study will be the first to investigate the possible mechanism of action that McKenzie therapy and motor control exercises have on the recruitment of the transversus abdominus in a cohort of low back pain patients sub-classified with a directional preference. Patients receiving matched exercises according to their directional preference are believed to have better outcomes than those receiving unmatched exercises. A better understanding of the mechanism of action that specific treatments such as motor control exercises or McKenzie exercises have on patients classified with a directional preference will allow therapist to make a more informed choice about treatment options. Copyright © 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Overcoming Addictions, a Web-Based Application, and SMART Recovery, an Online and In-Person Mutual Help Group for Problem Drinkers, Part 2: Six-Month Outcomes of a Randomized Controlled Trial and Qualitative Feedback From Participants.
Campbell, William; Hester, Reid K; Lenberg, Kathryn L; Delaney, Harold D
Despite empirical evidence supporting the use of Web-based interventions for problem drinking, much remains unknown about factors that influence their effectiveness. We evaluated the performance of 2 resources for people who want to achieve and maintain abstinence: SMART Recovery (SR) and Overcoming Addictions (OA). OA is a Web application based on SR. We also examined participant and intervention-related factors hypothesized to impact clinical outcomes of Web-based interventions. We recruited 189 heavy drinkers through SR's website and in-person meetings throughout the United States. We began by randomly assigning participants to (1) SR meetings alone, (2) OA alone, and (3) OA and SR (OA+SR). Recruitment challenges compelled us to assign participants only to SR (n=86) or OA+SR (n=102). The experimental hypotheses were as follows: (1) Both groups will reduce their drinking and alcohol-related consequences at follow-up compared with their baseline levels, and (2) The OA+SR condition will reduce their drinking and alcohol or drug-related consequences more than the SR only condition. Additionally, we derived 3 groups empirically (SR, OA, and OA+SR) based on the participants' actual use of each intervention and conducted analyses by comparing them. Primary outcome measures included percent days abstinent (PDA), mean drinks per drinking day (DDD), and alcohol or drug-related consequences. Postbaseline assessments were conducted by phone at 3 and 6 months. Secondary analyses explored whether clinical issues (eg, severity of alcohol problems, level of distress, readiness to change) or intervention-related factors (eg, Internet fluency, satisfaction with site) affected outcomes. Both intent-to-treat analyses and the actual-use analyses showed highly significant improvement from baseline to follow-ups for all 3 groups. Mean within-subject effect sizes were large (d>0.8) overall. There was no significant difference between groups in the amount of improvement from baseline to
Brushøj, Christoffer; Larsen, Klaus; Albrecht-Beste, Elisabeth; Nielsen, Michael Bachmann; Løye, Finn; Hölmich, Per
It is unknown whether an exercise program can prevent overuse injuries in the lower extremity. An often encountered and important risk factor for the development of lower extremity overuse injuries is an abrupt increase in activity level. A preventive training program based on a literature review of intrinsic risk factors, and performed concurrent with an increase in physical activity, can reduce the incidence of overuse knee injuries and medial tibial stress syndrome, as well as increase running distance. Randomized controlled trial; Level of evidence, 1. A total of 1020 soldiers aged 20.9 years (range, 19-26 years) undergoing 3 months of basic military training consecutively enrolled from December 2004 to December 2005. The prevention program consisted of an exercise program of 15 minutes' duration 3 times a week, including 5 exercises for strength, flexibility, and coordination; the placebo program consisted of 5 exercises for the upper body. During the observation period, 223 subjects sustained an injury, with 50 and 48 of these fulfilling the study criteria for overuse knee injuries or medial tibial stress syndrome, respectively. There were no significant differences in incidence of injury between the prevention group and the placebo group (incidence, 0.22 vs 0.19; P = .162; relative risk = 1.05 [range, 0.98-1.11]). The soldiers in the prevention group had the greater improvement in running distance in 12-minute run tests (82 vs 43 m; P = .037). An exercise program with an emphasis on muscular strengthening, coordination, and flexibility based on intrinsic risk factors identified through a literature review did not influence the risk of developing overuse knee injuries or medial tibial stress syndrome in subjects undergoing an increase in physical activity. The program increased maximal running distance in a 12-minute test.
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
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.
Broberg, Gudrun; Gyrd-Hansen, Dorte; Miao Jonasson, Junmei; Ryd, Mare-Liis; Holtenman, Mikael; Milsom, Ian; Strander, Björn
RACOMIP is a population-based, randomized trial of the effectiveness and cost-effectiveness of different interventions aimed at increasing participation in a well-run cervical cancer screening program in western Sweden. In this article, we report results from one intervention, offering non-attendees a high-risk human papillomavirus (HPV) self-test. Comparison was made with standard screening invitation routine or standard routine plus a telephone call. Women (8,800), aged 30-62, were randomly selected among women without a registered Pap smear in the two latest screening rounds. These women were randomized 1:5:5 to one of three arms: 800 were offered a high-risk HPV self-test, 4,000 were randomized to a telephone call (reported previously) and 4,000 constituted a control group (standard screening invitation routine). Results were based on intention to treat analysis and cost-effectiveness was calculated as marginal cost per cancer case prevented. The endpoint was the frequency of testing. The total response rate in the self-testing arm was 24.5%, significantly higher than in the telephone arm (18%, RR 1.36, 95% CI 1.19-1.57) and the control group (10.6%, RR 2.33, 95% CI 2.00-2.71). All nine women who tested positive for high-risk HPV attended for a cervical smear and colposcopy. From the health-care sector perspective, the intervention will most likely lead to no additional cost. Offering a self-test for HPV as an alternative to Pap smears increases participation among long-term non-attendees. Offering various screening options can be a successful method for increasing participation in this group. © 2013 UICC.
Lobraico, Jessika M; DiLello, Lauren C; Butler, Amber D; Cordisco, Marie Elena; Petrini, Joann R; Ahmadi, Ramin
The purpose of this trial was to evaluate the effect of krill oil supplementation, a source of ω-3 fatty acids, on cardiovascular disease risk factors and blood glucose control among participants with type 2 diabetes. A randomized, double-blind controlled cross-over trial was employed. Outcomes assessed were: endothelial function, blood lipids, glucose, glycated hemoglobin, serum antioxidant level, C peptide, and calculated Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) scores. Participants were randomized to either krill oil or olive oil supplementation for 4 weeks, underwent a 2-week washout period, and then crossed to the other supplementation for 4 weeks. All participants were then offered an additional 17 weeks of krill supplementation. Testing occurred at 3 time points: baseline, after first supplementation, and after second supplementation. Testing also occurred after an optional 17 weeks of krill oil supplementation. Difference scores were calculated for each participant in both sequences (ie, differences in outcome measures in the first and second period of the sequence). The mean and SD of the scores in the 2 sequence groups were used to test for differences between treatment effects at a significance level of pkrill oil for 4 weeks had an improvement in their endothelial function and a reduction in blood C peptide levels and HOMA scores as compared with the olive oil. A total of 34 participants completed the additional 17-week supplementation period. When compared with their respective baseline measures, these participants had a statistically significant improvement in endothelial function and blood high-density lipoprotein (HDL). Krill oil may lead to moderate improvement of cardiovascular risks, specifically endothelial dysfunction and HDL in patients with type 2 diabetes. Registered with ClinicalTrials.gov: NCT02091193.
Lamerato, Lois E; Marcus, Pamela M; Jacobsen, Gordon; Johnson, Christine Cole
Recruitment of healthy subjects to long-term randomized controlled trials (RCTs) of cancer prevention or early detection has proven to be a difficult task. To quantify recruitment yield as well as characteristics of successfully recruited participants, we examined recruitment outcomes at 1 of the 10 centers participating in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial, a National Cancer Institute-funded RCT of cancer screening modalities. During the early recruitment phase of PLCO (1993-1997), data on recruitment outcome were collected at the Henry Ford Health System (HFHS) in Detroit, Michigan. In this phase, HFHS identified potential participants using patient databases. Records were used to assess recruitment success by age, sex, race, household income (using area-based U.S. Census data), and preexisting morbidity. Logistic regression was used to assess whether enrollment success differed significantly according to these factors. Of 74,139 persons ages 55 to 74 invited by HFHS to participate, 8,250 (11%) ;enrolled. In multivariate analyses, the odds of enrolling were modestly but significantly higher for women, Caucasians, persons in their 60's, and persons living in census blocks with higher median household income. Persons with two or more preexisting morbidities had significantly lower odds of enrolling compared to those with one or no preexisting morbidities. These data suggest that only a small fraction of persons invited to enroll in long-term RCTs of cancer screening modalities actually do so. In this urban, Midwestern setting, certain characteristics including age, race, and income influenced recruitment success, albeit modestly.
Stanton, Annette L.; Morra, Marion E.; Miller, Suzanne M.; Diefenbach, Michael A.; Slevin-Perocchia, Rosemarie; Raich, Peter C.; Fleisher, Linda; Wen, Kuang-Yi; Tran, Zung Vu; Mohamed, Nihal E.; George, Roshini; Bright, Mary Anne; Marcus, Alfred C.
Purpose When faced with a significant recruitment challenge for three nationwide psycho-educational trials targeting prostate and breast cancer patients, the Cancer Information Service Research Consortium initiated outreach efforts to increase accrual. Recruitment is reported by major outreach strategy to inform the use of similar campaigns, either as primary recruitment efforts or to supplement “in-reach” recruitment within oncology settings. Methods During a 33-month period, recruitment was tracked from the National Cancer Institute’s Cancer Information Service (CIS), the American Cancer Society (ACS), Dr. Susan Love Research Foundation’s Love/Avon Army of Women (AOW), Internet advertising, press releases, radio/television interviews, recruitment materials in community venues, and outreach to churches and cancer support organizations. Results Across projects, the majority (89%) of recruited participants (N = 2,134) was obtained from the CIS (n = 901, 19 months of recruitment), AOW (n = 869, 18 months), and ACS (n = 123, 12 months). Other efforts showed minimal gain in recruitment. Conclusions Cancer information programs (e.g., CIS, ACS) and registries of individuals willing to participate in cancer-related research (e.g., AOW) can represent exceptional resources for outreach recruitment of cancer patients, especially when the eligibility criteria are highly restrictive. However, these resources do not yield samples representative of the larger population of adults diagnosed with cancer, and conclusions from such trials must be tempered accordingly. Implications for cancer survivors Inadequate recruitment to randomized controlled trials limits the creation of useful interventions for cancer survivors. By enrolling in cancer registries and taking part in research, cancer survivors can contribute to the development of effective resources for the survivor population. PMID:23595235
Stanton, Annette L; Morra, Marion E; Diefenbach, Michael A; Miller, Suzanne M; Slevin Perocchia, Rosemarie; Raich, Peter C; Fleisher, Linda; Wen, Kuang-Yi; Tran, Zung Vu; Mohamed, Nihal E; George, Roshini; Bright, Mary Anne; Marcus, Alfred C
When faced with a significant recruitment challenge for three nationwide psychoeducational trials targeting prostate and breast cancer patients, the Cancer Information Service Research Consortium initiated outreach efforts to increase accrual. Recruitment is reported by major outreach strategy to inform the use of similar campaigns, either as primary recruitment efforts or to supplement "in-reach" recruitment within oncology settings. During a 33-month period, recruitment was tracked from the National Cancer Institute's Cancer Information Service (CIS), the American Cancer Society (ACS), Dr. Susan Love Research Foundation's Love/Avon Army of Women (AOW), Internet advertising, press releases, radio/television interviews, recruitment materials in community venues, and outreach to churches and cancer support organizations. Across projects, the majority (89 %) of recruited participants (N = 2,134) was obtained from the CIS (n = 901, 19 months of recruitment), AOW (n = 869, 18 months), and ACS (n = 123, 12 months). Other efforts showed minimal gain in recruitment. Cancer information programs (e.g., CIS and ACS) and registries of individuals willing to participate in cancer-related research (e.g., AOW) can represent exceptional resources for outreach recruitment of cancer patients, especially when the eligibility criteria are highly restrictive. However, these resources do not yield samples representative of the larger population of adults diagnosed with cancer, and conclusions from such trials must be tempered accordingly. Inadequate recruitment to randomized controlled trials limits the creation of useful interventions for cancer survivors. By enrolling in cancer registries and taking part in research, cancer survivors can contribute to the development of effective resources for the survivor population.
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
Background: Evidence supporting the effectiveness of aerobic training, specific for fatigue, in severely fatigued patients with multiple sclerosis (MS) is lacking. Objective: To estimate the effectiveness of aerobic training on MS-related fatigue and societal participation in ambulant patients with severe MS-related fatigue. Methods: 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. Results: 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. Conclusion: 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. PMID:28528566
Full Text Available To investigate the feasibility, costs and sample representativeness of a recruitment method that used workers with back injuries as the point of entry into diverse working environments.Workers' compensation claims were used to randomly sample workers from five heavy industries and to recruit their employers for ergonomic assessments of the injured worker and up to 2 co-workers.The final study sample included 54 workers from the workers' compensation registry and 72 co-workers. This sample of 126 workers was based on an initial random sample of 822 workers with a compensation claim, or a ratio of 1 recruited worker to approximately 7 sampled workers. The average recruitment cost was CND$262/injured worker and CND$240/participating worksite including co-workers. The sample was representative of the heavy industry workforce, and was successful in recruiting the self-employed (8.2%, workers from small employers (<20 workers, 38.7%, and workers from diverse working environments (49 worksites, 29 worksite types, and 51 occupations.The recruitment rate was low but the cost per participant reasonable and the sample representative of workers in small worksites. Small worksites represent a significant portion of the workforce but are typically underrepresented in occupational research despite having distinct working conditions, exposures and health risks worthy of investigation.
Courneya, Kerry S; Friedenreich, Christine M; Sela, Rami A; Quinney, H Arthur; Rhodes, Ryan E; Jones, Lee W
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.
Heppe, Eline C M; Kef, Sabina; Schuengel, Carlo
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
Van Wely, Leontien; Balemans, Astrid Cj; Becher, Jules G; Dallmeijer, Annet J
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.
Reid, Susan A; Callister, Robin; Katekar, Michael G; Rivett, Darren A
To evaluate and compare the effects of 2 manual therapy interventions on cervical spine range of motion (ROM), head repositioning accuracy, and balance in patients with chronic cervicogenic dizziness. Randomized controlled trial with 12-week follow-up using blinded outcome assessment. University School of Health Sciences. Participants (N=86; mean age ± SD, 62.0 ± 12.7 y; 50% women) with chronic cervicogenic dizziness. Participants were randomly assigned to 1 of 3 groups: sustained natural apophyseal glides (SNAGs) with self-SNAG exercises, passive joint mobilization (PJM) with ROM exercises, or a placebo. Participants each received 2 to 6 treatments over 6 weeks. Cervical ROM, head repositioning accuracy, and balance. SNAG therapy resulted in improved (P ≤.05) cervical spine ROM in all 6 physiological cervical spine movement directions immediately posttreatment and at 12 weeks. Treatment with PJM resulted in improvement in 1 of the 6 cervical movement directions posttreatment and 1 movement direction at 12 weeks. There was a greater improvement (PManual therapy had no effect on balance or head repositioning accuracy. SNAG treatment improved cervical ROM, and the effects were maintained for 12 weeks after treatment. PJM had very limited impact on cervical ROM. There was no conclusive effect of SNAGs or PJMs on joint repositioning accuracy or balance in people with cervicogenic dizziness. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
Holm, Anna B.
Up to now, there has been little research on the impact of e-recruitment on the recruitment process as a whole. The present study fills part of this gap by investigating the effect of e-recruitment on the design of the recruitment process. Three explorative case studies were carried out in three...... large organisations in Denmark in 2008-2010. The findings indicate that e-recruitment transforms the traditional recruitment process into a time- and space-independent, collaborative hiring process. The most significant changes are recorded in the sequence and increased divisibility of main recruitment...... tasks and subtasks. For management, the main task is now that of communicating with candidates. In addition, a new on-going task of maintaining a corporate career website has become an integral part of the new recruitment process. The new design is presented in the following, and its implications...
Prescott, Tonya L; Phillips Ii, Gregory; DuBois, L Zachary; Bull, Sheana S; Mustanski, Brian; Ybarra, Michele L
Using social networking websites to recruit research participants is increasingly documented in the literature, although few studies have leveraged these sites to reach those younger than 18 years. To discuss the development and refinement of a recruitment protocol to reach and engage adolescent gay, bisexual, and other teenaged men who have sex with men (AGBM). Participants were recruited for development and evaluation activities related to Guy2Guy, a text messaging-based human immunodeficiency virus infection prevention program. Eligibility criteria included being between 14 to 18 years old; being a cisgender male; self-identifying as gay, bisexual, and/or queer; being literate in English, exclusively owning a cell phone, enrolled in an unlimited text messaging plan, intending to keep their current phone number over the next 6 months, and having used text messaging for at least the past 6 months. Recruitment experiences and subsequent steps to refine the Internet-based recruitment strategy are discussed for 4 research activities: online focus groups, content advisory team, beta test, and randomized controlled trial (RCT). Recruitment relied primarily on Facebook advertising. To a lesser extent, Google AdWords and promotion through partner organizations working with AGBM youth were also utilized. Facebook advertising strategies were regularly adjusted based on preidentified recruitment targets for race, ethnicity, urban-rural residence, and sexual experience. The result was a diverse sample of participants, of whom 30% belonged to a racial minority and 20% were Hispanic. Facebook advertising was the most cost-effective method, and it was also able to reach diverse recruitment goals: recruitment for the first focus group cost an average of US $2.50 per enrolled participant, and it took 9 days to enroll 40 participants; the second focus group cost an average of US $6.96 per enrolled participant, and it took 11 days to enroll 40 participants. Recruitment for the
E-recruitment, also known as online or web-based recruitment, is little discussed in research from an organizational perspective. The purpose of this chapter is therefore to analyze and discuss the process of e-recruitment, its key constituents and organizing principles. In doing so I draw on the...
This document contains three papers from a symposium on recruitment and training. "College Choice: The State of Marketing and Effective Student Recruitment Strategies" (Fredrick Muyia Nafukho, Michael F. Burnett) reports on a study of the recruitment strategies used by Louisiana State University's admissions office and College of…
Who benefits from emotional expression? An examination of personality differences among gynaecological cancer patients participating in a randomized controlled emotional disclosure intervention trial.
Zakowski, Sandra G; Herzer, Michele; Barrett, Sara Dittoe; Milligan, Jessica Gerfen; Beckman, Nancy
The present study examined the role of neuroticism and extraversion in the effects of written emotional disclosure in patients diagnosed with gynaecological cancer. It was hypothesized that high levels of neuroticism would be associated with an increase in distress after emotional disclosure as mediated by heightened negative affect and avoidance post-disclosure. Conversely, we expected high extraversion to be associated with decreased distress as mediated by heightened positive moods and a decrease in avoidance. Eighty-eight participants were randomly assigned to participate in an expressive writing task versus a control writing task. Distress and avoidance were assessed at baseline and 6 months post-writing. Negative and positive mood were assessed immediately following writing. Multiple regression confirmed that neuroticism but not extraversion moderates the effects of emotional disclosure on distress, however no significant mediating relationships were found. ©2010 The British Psychological Society.
Seltzer, Erica D.; Stolley, Melinda R.; Mensah, Edward K.; Sharp, Lisa K.
Purpose The recent and rapid growth of social networking site (SNS) use presents a unique public health opportunity to develop effective strategies for the recruitment of hard-to-reach participants for cancer research studies. This survey investigated childhood cancer survivors’ reported use of SNS such as facebook or MySpace and their perceptions of using SNS, for recruitment into survivorship research. Methods Sixty White, Black and Hispanic, adult childhood cancer survivors (range 18 – 48 years of age) that were randomly selected from a larger childhood cancer study, the Chicago Healthy Living Study (CHLS), participated in this pilot survey. Telephone surveys were conducted to understand current SNS activity and attitudes towards using SNS as a cancer research recruitment tool. Results Seventy percent of participants reported SNS usage of which 80% were at least weekly users and 79 % reported positive attitudes towards the use of SNS as a recruitment tool for survivorship research. Conclusions and implications for cancer survivors The results of this pilot study revealed that SNS use was high and regular among the childhood cancer survivors sampled. Most had positive attitudes towards using SNS for recruitment of research. The results of this pilot survey suggest that SNS may offer an alternative approach for recruitment of childhood cancer survivors into research. PMID:24532046
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
The aim of this research was to determine whether the introduction of e-recruitment has an impact on the process and underlying tasks, subtasks and activities of recruitment. Three large organizations with well-established e-recruitment practices were included in the study. The three case studies......, which were carried out in Denmark in 2008-2009 using qualitative research methods, revealed changes in the sequence, divisibility and repetitiveness of a number of recruitment tasks and subtasks. The new recruitment process design was identified and presented in the paper. The study concluded...
Streibelt, Marco; Bethge, Matthias
This study examined the effects of work-related multidisciplinary rehabilitation (MR) on occupational participation in patients with chronic musculoskeletal disorders. A randomized-controlled trial was carried out. The sample included patients with chronic musculoskeletal disorders and severe restrictions of work ability (n=222). Participants in the intervention group received a work-related rehabilitation programme following a comprehensive functional capacity evaluation (FCE MR). Controls completed a conventional MR. The analysis was based on 1-year follow-up data. The primary outcome was stable occupational participation (SOP), defined as employment with at most 6 months of sick leave after rehabilitation. The secondary outcomes were the duration of sick leave, employment status and the Pain Disability Index. We included 102 patients in our analysis (intervention: n=55, control: n=47). Despite randomization there were group differences. Adjusting these differences, patients of the FCE MR had 3.5 times higher odds of SOP [95% confidence interval (CI): 1.2-9.8, P=0.018]. However, there was neither a significant difference in the duration of sick leave between both groups (b=-8.0 weeks, 95% CI: -17.4 to 1.4, P=0.095) nor higher odds of employment in favour of the FCE MR after 1 year (odds ratio=2.3, 95% CI: 0.9-5.8, P=0.088). Participants in the FCE MR reported less pain-related disabilities (b=-6.5, 95% CI: -12.6 to -0.4, P=0.038). The study had a limitation in terms of group balance. However, the findings indicate that the work-related FCE MR was more effective for SOP, but did not significantly affect employment rate and sick leave duration.
Full Text Available Diacerein seems to improve metabolic control and reduce inflammatory marker levels in individuals with type 2 diabetes mellitus (Type 2 DM, but for participants with chronic kidney disease (CKD its effect is unknown. This study aimed to evaluate the effect of diacerein vs. placebo on urinary albumin/creatinine ratio (ACR, glomerular filtration rate (GFR, and inflammatory cytokines in type 2 DM participants with CKD. Blood pressure (BP and metabolic control were secondary outcomes. This randomized, placebo-controlled, parallel trial of adjuvant treatment of type 2 DM with diacerein enrolled seventy-two participants with CKD, aged 30-80 years, with glycated hemoglobin levels from 53-97 mmol/mol (7.0-11.0%, receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and antidiabetic agents. Participants randomized to diacerein or placebo were followed-up up to 90 days. Both groups had a marked reduction in ACR, but there was no effect on glomerular filtration rate. While the diacerein group had reduced TNF-α levels at the 75th percentile with a borderline significance (P = 0.05, there were no changes in the IL levels at the 75th percentile. Diacerein prevented the increase in blood glucose to the level observed in the placebo group (P = 0.04, improving metabolic control by 74%, reducing 24-hour diastolic BP, nighttime systolic and diastolic BP compared to the placebo group. In conclusion, among patients with type 2 DM and CKD, diacerein does not have an effect on ACR or GFR, but slows metabolic control deterioration and is associated with lower nighttime systolic and diastolic blood pressure.Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clinicos; ReBeC U1111-1156-0255.
Intensive lifestyle intervention in general practice to prevent type 2 diabetes among 18 to 60-year-old South Asians: 1-year effects on the weight status and metabolic profile of participants in a randomized controlled trial.
Admiraal, Wanda M; Vlaar, Everlina M; Nierkens, Vera; Holleman, Frits; Middelkoop, Barend J C; Stronks, Karien; van Valkengoed, Irene G M
To study 1-year effectiveness of an intensive, culturally targeted lifestyle intervention in general practice for weight status and metabolic profile of South-Asians at risk of type 2 diabetes. 536 South-Asians at risk of type 2 diabetes were randomized to an intervention (n = 283) or control (n = 253) group. The intervention, which was targeted culturally to the South-Asian population, consisted of individual lifestyle counselling, a family session, cooking classes, and supervised physical activity programme. All components of the intervention were carried out by professionals as part of their daily clinical practice. The control group received generic lifestyle advice. Change in weight status and metabolic profile were assessed after 1 year. After 1 year, 201 participants were lost to follow-up. Remaining participants in intervention (n = 177) and control (n = 158) group had similar baseline characteristics. Weight loss in the intervention group was 0.2±3.3 kg, weight gain in the control group was 0.4±3.1 kg (p = 0.08). Changes in other weight-related measurements did not differ significantly between groups. Furthermore, there were no differences between groups in changes of metabolic profile. All results remained similar after repeating analyses in a multiple imputed dataset. An intensive, culturally targeted, lifestyle intervention of 1 year did not improve weight status and metabolic profile of South-Asians at risk of type 2 diabetes. The laborious recruitment, high drop-out, and lack of effectiveness emphasise the difficulty of realising health benefits in practice and suggest that this strategy might not be the optimal approach for this population. Nederlands Trial Register NTR1499.
Brown, Sharon A; García, Alexandra A; Orlander, Philip R; Hanis, Craig L
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. 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. 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. 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.
Sharon A Brown
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.
Pot-Kolder, Roos; Veling, Wim; Geraets, Chris; van der Gaag, Mark
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.
Elizabeth Mahon; Jamie Roberts; Pat Furlong; Gina Uhlenbrauck; Jonca Bull
... (even though some participants may have had personal benefit).2 Insufficient recruitment also results in missed opportunities for patients who can benefit from clinical trials, and wastes time, funds, and other resources...
Thomas, Kali S; Akobundu, Ucheoma; Dosa, David
Nutrition service providers are seeking alternative delivery models to control costs and meet the growing need for home-delivered meals. The objective of this study was to evaluate the extent to which the home-delivered meals program, and the type of delivery model, reduces homebound older adults' feelings of loneliness. This project utilizes data from a three-arm, fixed randomized control study conducted with 626 seniors on waiting lists at eight Meals on Wheels programs across the United States. Seniors were randomly assigned to either (i) receive daily meal delivery; (ii) receive once-weekly meal delivery; or (iii) remain on the waiting list. Participants were surveyed at baseline and again at 15 weeks. Analysis of covariance was used to test for differences in loneliness between groups, over time and logistic regression was used to assess differences in self-rated improvement in loneliness. Participants receiving meals had lower adjusted loneliness scores at follow-up compared with the control group. Individuals who received daily-delivered meals were more likely to self-report that home-delivered meals improved their loneliness than the group receiving once-weekly delivered meals. This article includes important implications for organizations that provide home-delivered meals in terms of cost, delivery modality, and potential recipient benefits. Published by Oxford University Press on behalf of the Gerontological Society of America 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.
Full Text Available Abstract Background The success and cost-effectiveness of bowel cancer screening depends on achieving and maintaining high screening uptake rates. The involvement of GPs in screening has been found to improve patient compliance. Therefore, the endorsement of screening by GPs may increase uptake rates amongst non-responders. Methods/Design A two-armed randomised controlled trial will evaluate the effectiveness of a GP endorsed reminder in improving patient participation in the NHS Bowel Cancer Screening Programme (NHSBCSP. Up to 30 general practices in the West Midlands with a screening uptake rate of less than 50% will be recruited and patients identified from the patient lists of these practices. Eligible patients will be those aged 60 to 74, who have previously been invited to participate in bowel screening but who have been recorded by the Midlands and North West Bowel Cancer Screening Hub as non-responders. Approximately 4,380 people will be randomised in equal numbers to either the intervention (GP letter and duplicate FOBt kit or control (no additional contact arms of the trial. The primary outcome measure will be the difference in the uptake rate of FOBt screening for bowel cancer between the intervention and control groups at 13 weeks after the GP endorsed reminder and duplicate FOBt kit are sent. Secondary outcome measures will be subgroup analyses of uptake according to gender, age and deprivation quartile, and the validation of methods for collecting GP, NHSBCSP and patient costs associated with the intervention. Qualitative work (30 to 40 semi-structured interviews will be undertaken with individuals in the intervention arm who return a FOBt kit, to investigate the relative importance of the duplicate FOBt kit, reminder to participate, and GP endorsement of that reminder in contributing to individuals' decisions to participate in screening. Discussion Implementing feasible, acceptable and cost-effective strategies to improve
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
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.
Shah, Anand [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Efstathiou, Jason A.; Paly, Jonathan J. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Halpern, Scott D. [Department of Medicine, University of Pennsylvania, Philadelphia, PA (United States); Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA (United States); Center for Bioethics, University of Pennsylvania, Philadelphia, PA (United States); Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA (United States); Bruner, Deborah W. [Winship Cancer Institute, Emory University, Atlanta, GA (United States); Christodouleas, John P. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Coen, John J. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Deville, Curtiland; Vapiwala, Neha [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Shipley, William U.; Zietman, Anthony L. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Hahn, Stephen M. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Bekelman, Justin E., E-mail: firstname.lastname@example.org [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA (United States)
Purpose: To investigate patients' willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa). Methods and Materials: We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients' stated WTP was assessed using a 6-point Likert scale. Results: Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients' WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either 'definitely' or 'probably' participate. Seventeen percent (8 of 46) stated they would 'definitely not' or 'probably not' enroll, most of whom (6 of 8) preferred PBT before their physician visit. Conclusions: A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa.
Puentedura, Emilio J; Buckingham, Sarah J; Morton, Daniella; Montoya, Crystal; Fernandez de Las Penas, Cesar
The purpose of this study was to investigate changes in resting and/or contraction thickness of the transversus abdominis (TrA) muscle after dry needling (DN) of the lumbar multifidus (LM) in asymptomatic participants. A randomized controlled laboratory trial with crossover design was performed. Forty-seven healthy individuals who had not experienced low back pain in the previous 6 months were randomly assigned to receive DN to the LM or a sham-DN intervention. Participants received both interventions separated at least 7 days apart. They were instructed on how to perform a concentric contraction of TrA. Resting and contraction thicknesses of the TrA were obtained through real-time ultrasound measurements before and immediately after each intervention by an assessor blinded to the intervention received. Data from 4 individuals had to be excluded because of poor image quality. Two-way analysis of variance revealed a significant contraction with treatment interaction (F[1,42] = 11.489; P = .002). Simple main effects using paired-samples t tests and a Bonferroni post hoc analysis revealed differences in contracted states of the TrA for DN vs sham-DN (P = .009) and between contracted and resting states for the DN group (P = .001): after DN, TrA thickness at rest exhibited a mean decrease of 0.03 cm and a mean increase of 0.05 cm during contraction. This study suggests that application of DN to LM was accompanied by a decreased resting thickness and an increased contraction thickness of the TrA in asymptomatic participants. Copyright © 2017. Published by Elsevier Inc.
Wilson, Rhonda Lynne; Usher, Kim
BACKGROUND: The development of a recruitment strategy requires nurse researchers to consider the avenues available to them to fully investigate a phenomenon. In many cases, this will mean that they invite members of the public to be participants in their research. Successfully advertising...... to a downturn in traditional forms of media, such as television, radio and printed newspapers, magazines and newsletters. Increasingly, the public is using social media instead of traditional media. This change has implications for the design of research and researchers will have to adapt their recruitment......, investigating help and support for young people's mental health, can adapt their traditional recruitment practices and applied this new knowledge to recruitment using social media. DISCUSSION: A carefully designed social media recruitment process was particularly useful in attracting informative participant...
Avelino, Patrick Roberto; Nascimento, Lucas R; Menezes, Kênia K P; Scianni, Aline A; Ada, Louise; Teixeira-Salmela, Luci F
Canes are usually prescribed for individuals with stroke with the purpose of improving walking and increasing safety. However, there is no consensus regarding the clinical effects of these aids on walking and participation. This study will examine the efficacy of the provision of a cane to improve walking and increase participation after stroke. This is a two-arm, prospectively registered, randomized trial with concealed allocation, blinded measurers, and intention-to-treat analysis. Fifty individuals with chronic stroke, categorized as slow or intermediate walkers (walking speeds ≤0.8m/s), will participate. The experimental group will receive a single-point cane and instructions to use the cane anytime they need to walk. The control group will receive a placebo intervention, consisting of self-stretching exercises of the lower limb muscles and instructions to not use assistive devices. The primary outcome will be comfortable walking speed. Secondary outcomes will include walking step length, walking cadence, walking capacity, walking confidence, and participation. Outcomes will be collected by a researcher blinded to group allocation at baseline (Week 0), after intervention (Week 4), and one month beyond intervention (Week 8). The provision of a single-point cane may help improving walking of slow and intermediate walkers after stroke. If walking is enhanced, the benefits may be carried over to participation, and individuals may experience greater free-living physical activity at home and in the community. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.
Unlu, B.; Cuijpers, P.; van t Hof, E.; Riper, H.
Ethnic minorities are underrepresented in mental health research, especially in randomized controlled trials. Recruiting ethnic minorities is challenging and there is a need to develop effective recruitment strategies. This study used data from a randomized controlled trial examining the
Heredia-Rizo, Alberto Marcos; Oliva-Pascual-Vaca, Angel; Rodríguez-Blanco, Cleofás; Piña-Pozo, Fernando; Luque-Carrasco, Antonio; Herrera-Monge, Patricia
This study aimed to assess the immediate effects on masticatory muscle mechanosensitivity, maximal vertical mouth opening (VMO), and head posture in pain-free healthy participants after intervention with myofascial treatment in the temporalis and masseter muscles. A randomized, double-blind study was conducted. The sample group included 48 participants (n=48), with a mean age of 21±2.47 years (18-29). Two subgroups were defined: an intervention group (n=24), who underwent a fascial induction protocol in the masseter and temporalis muscles, and a control group (n=24), who underwent a sham (placebo) intervention. The pressure pain threshold in 2 locations in the masseter (M1, M2) and temporalis (T1, T2) muscles, maximal VMO, and head posture, by means of the craniovertebral angle, were all measured. Significant improvements were observed in the intragroup comparison in the intervention group for the craniovertebral angle with the participant in seated (P.05). Myofascial induction techniques in the masseter and temporalis muscles show no significant differences in maximal VMO, in the mechanical sensitivity of the masticatory muscles, and in head posture in comparison with a placebo intervention in which the therapist's hands are placed in the temporomandibular joint region without exerting any therapeutic pressure. Copyright © 2013 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.
Full Text Available The role of nurse participation (NP in colonoscopy observation for polyp and adenoma detection is unclear. This study aimed to evaluate whether nurse participation can improve polyp and adenoma detection. Patients and Methods. The PUBMED, EMBASE, and Cochrane Library databases were searched for randomized controlled trials (RCTs published in English. The outcome measurements included (1 the polyp and adenoma detection rate (PDR and ADR; (2 the advanced lesions detection rate; and (3 the mean polyp and adenoma detection rate per colonoscopy. Results. Three RCTs with a total of 1676 patients were included. The pooled data showed a significantly higher ADR in the NP group than colonoscopist alone (CA (45.7% versus 39.3%; RR 1.16; 95% CI, 1.04–1.30. And it showed no significant difference in the PDR and advanced lesions detection rate between the two groups (RR: 1.14, 95% CI: 0.95–1.37; RR: 1.35, 95% CI: 0.91–2.00; resp.. Conclusions. Nurse participation during a colonoscopy can improve the ADR, whereas no benefit for the PDR and advanced lesions detection rate was observed. All RCTs included in the meta-analysis had high risk of bias. Thus, there is a need for new research that uses sound methodology to definitively address the research question under study.
Alexander L. Ivanov
Full Text Available The article is devoted to research of innovations in HR recruitment. The following issues, related to impact of innovations on recruitment development, are discussed: do innovative technologies mean prospects or threats for traditional recruitment? The research is based on the transformations review, which had an impact on all staff selection areas. The article describes up-to-date approaches and leading practices, which allow to draw a conclusion, that recruitment is highly sensitive against scientific and technical progress and has high innovation potential.
Troy, Jesse D; Hill, Heather R; Ewell, Marian G; Frey, Sharon E
Previous research shows immune response to vaccination differs by sex but this has not been explored for IMVAMUNE, a replication-deficient smallpox vaccine developed in response to the potential for bioterrorism using smallpox. We conducted a participant-level meta-analysis (N=275, 136 men, 139 women) of 3 randomized trials of IMVAMUNE conducted at 13 centers in the US through a federally-funded extramural research program. Studies were eligible for inclusion if they tested the standard dose (1×10(8)TCID₅₀/mL on Days 0 and 28) of liquid formulation IMVAMUNE, were completed at the time of our search, and enrolled healthy vaccinia-naïve participants. Models of the peak log₂ ELISA and PRNT titers post-second vaccination were constructed for each study with sex as a covariate. Results from these models were combined into random effects meta-analyses of the sex difference in response to IMVAMUNE. We then compared this approach with fixed effects models using the combined participant level data. In each study the mean peak log₂ ELISA titer was higher in men than women but no single study demonstrated a statistically significant difference. Combination of the adjusted study-specific estimates into the random effects model showed a higher mean peak log₂-titer in men compared with women (absolute difference [men-women]: 0.32, 95% CI: 0.02-0.60). Fixed effects models controlling for study showed a similar result (log₂ ELISA titer, men-women: 0.34, 95% CI: 0.04-0.63). This equates to a geometric mean peak titer that is approximately 27% higher in men than women (95% CI: 3-55%). Peak log₂ PRNT titers were also higher (although not significantly) in men (men-women: 0.14, 95% CI: -0.30 to 0.58). Our results show statistically significant differences in response to IMVAMUNE comparing healthy, vaccinia-naïve men with women and suggest that sex should be considered in further development and deployment of IMVAMUNE and other MVA-based vaccines. Copyright © 2015
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
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
Christensen, Darren R; Dowling, Nicki A; Jackson, Alun C; Thomas, Shane A
Demographic characteristics associated with gambling participation and problem gambling severity were investigated in a stratified random survey in Tasmania, Australia. Computer-assisted telephone interviews were conducted in March 2011 resulting in a representative sample of 4,303 Tasmanian residents aged 18 years or older. Overall, 64.8% of Tasmanian adults reported participating in some form of gambling in the previous 12 months. The most common forms of gambling were lotteries (46.5%), keno (24.3%), instant scratch tickets (24.3%), and electronic gaming machines (20.5%). Gambling severity rates were estimated at non-gambling (34.8%), non-problem gambling (57.4%), low risk gambling (5.3%), moderate risk (1.8%), and problem gambling (.7%). Compared to Tasmanian gamblers as a whole significantly higher annual participation rates were reported by couples with no children, those in full time paid employment, and people who did not complete secondary school. Compared to Tasmanian gamblers as a whole significantly higher gambling frequencies were reported by males, people aged 65 or older, and people who were on pensions or were unable to work. Compared to Tasmanian gamblers as a whole significantly higher gambling expenditure was reported by males. The highest average expenditure was for horse and greyhound racing ($AUD 1,556), double the next highest gambling activity electronic gaming machines ($AUD 767). Compared to Tasmanian gamblers as a whole problem gamblers were significantly younger, in paid employment, reported lower incomes, and were born in Australia. Although gambling participation rates appear to be falling, problem gambling severity rates remain stable. These changes appear to reflect a maturing gambling market and the need for population specific harm minimisation strategies.
Denis, B; Broc, G; Sauleau, E A; Gendre, I; Gana, K; Perrin, P
Despite the involvement of general practitioners, the mailing of several recall letters and of the faecal occult blood test (FOBT) kit, the uptake remains insufficient in the French colorectal cancer-screening programme. Some studies have demonstrated a greater efficacy of tailored telephone counselling over usual care, untailored invitation mailing and FOBT kit mailing. We evaluated the feasibility and the effectiveness of telephone counselling on participation in the population-based FOBT colorectal cancer-screening programme implemented in Alsace (France). Underusers were randomized into a control group with untailored invitation and FOBT kit mailing (n=19,756) and two intervention groups for either a computer-assisted telephone interview (n=9367), system for tailored promotion of colorectal cancer screening, or a telephone-based motivational interview (n=9374). Only 5691 (19.9%) people were actually counseled, so that there was no difference in participation between the intervention groups taken together (13.9%, 95% confidence interval [CI] [13.5-14.4]) and the control group (13.9%, 95% CI [13.4-14.4]) (P=1.0) in intent-to-treat analysis. However, in per-protocol analysis, participation was significantly higher in the two intervention groups than in the control group (12.9%, 95% CI [12.6-13.2]) (Pcounselling and untailored invitation and FOBT kit mailing on participation of underusers in an organized population-based colorectal cancer screening programme. A greater efficacy of telephone counselling, around twice that of invitation and FOBT kit mailing, was observed only in people who could actually be counseled, without difference between computer-assisted telephone interview and motivational interview. However, technical failures hampered telephone counselling, so that there was no difference in intent-to-treat analysis. The rate of technical success of telephone interviews should be evaluated, and enhanced if insufficient, before implementation of telephone
Full Text Available John M Mayer,1 James L Nuzzo,1 Simon Dagenais2 1School of Physical Therapy and Rehabilitation Sciences, College of Medicine, University of South Florida, Tampa, FL, 2Palladian Health, West Seneca, NY, USA Background: Firefighters are at increased risk for back injuries, which may be mitigated through exercise therapy to increase trunk muscle endurance. However, long-term adherence to exercise therapy is generally poor, limiting its potential benefits. Focus groups can be used to identify key barriers and facilitators to exercise adherence among study participants. Objective: To explore barriers and facilitators to worksite exercise therapy adherence among firefighters to inform future randomized controlled trials (RCTs. Methods: Participants enrolled in a previous RCT requiring twice-weekly worksite exercise therapy for 24 weeks were asked to take part in moderated focus group discussions centered on eight open-ended questions related to exercise adherence. Responses were analyzed qualitatively using a social ecological framework to identify key intrapersonal, interpersonal, and institutional barriers and potential facilitators to exercise adherence. Results: A total of 27 participants were included in the four focus group discussions, representing 50% of those assigned to a worksite exercise therapy group in the previous RCT, in which only 67% of scheduled exercise therapy sessions were completed. Lack of self-motivation was cited as the key intrapersonal barrier to adherence, while lack of peer support was the key interpersonal barrier reported, and lack of time to exercise during work shifts was the key institutional barrier identified. Conclusion: Focus group discussions identified both key barriers and potential facilitators to increase worksite exercise therapy adherence among firefighters. Future studies should consider educating and reminding participants about the benefits of exercise, providing individual and group incentives based on
Simsek, Ismail; Yazici, Yusuf
It is important to evaluate how a randomized controlled trial (RCT) sample was assembled from the general patient population in order to determine whether a patient differs from those who participated in the trial in a meaningful way. The aim of this study is to assess the adequacy of reporting of the recruitment process of rheumatoid arthritis (RA) patients participating in RCTs with biologic agents. We searched PubMed for all reports of RCTs involving etanercept, infliximab, adalimumab, golimumab, certolizumab, abatacept, tocilizumab, and rituximab in RA patients. Data recorded were eligibility fraction, enrollment fraction, recruitment fraction, and number of patients needed to be screened (NNS) in order to randomize 1 participant. Of the 66 trials included in the analysis, 23 (35%) reported the number of individuals assessed by investigators for eligibility, and 18 (27%) reported the number eligible for participation. Of the studies that reported quantitative recruitment information, the median eligibility fraction was 80.6% (interquartile range [IQR] 71.8-91.1%) and the median enrollment fraction was 100% (IQR 88.4-100%). The median NNS was found to be 1.28 (IQR 1.18-1.43). A substantial majority of RCTs conducted in RA patients with biologic agents did not provide sufficient information about the patient recruitment process, which makes assessments of external validity difficult. The rate of reporting of the recruitment process in this study was found to be lower as compared to similar studies conducted in different specialties. Copyright © 2012 by the American College of Rheumatology.
Lynch, Andrew D; Bove, Allyn M; Ammendolia, Carlo; Schneider, Michael
The effectiveness of treatments for chronic, degenerative conditions of the lumbar spine can be influenced by patient perceptions and expectations regarding treatment. The primary purpose of this study was to understand the factors that are important to individuals with lumbar spinal stenosis (LSS) regarding different non-surgical treatments. These factors were considered within the context of each treatment received as a part of the parent randomized controlled trial (RCT). Focus Group study of RCT participants PATIENT SAMPLE: Convenience sample of 50 individuals with LSS (28 female, average age 73 ± 7.7 years) from an RCT participated in one of six focus groups. Focus groups consisted of patients previously randomized to one of three non-surgical treatments: 1) medical care; 2) community-based group exercise; and 3) clinic-based manual therapy and individualized exercise. Experiences, opinions, and preferences of individuals with LSS who participated in an RCT. Inter-coder agreement for qualitative analysis was conducted with kappa statistics. Participants discussed their experiences and perceptions regarding study treatment and their general experience with LSS using open-ended questions provided by a facilitator. Transcripts were coded according to modified grounded theory in an open approach, using codes that addressed the primary focus group discussion topics (primary coding) and codes for emerging topics (secondary coding). Secondary coding sought to identify themes concerning living with LSS and seeking treatment that were emergent from the focus groups. This study was funded by the Patient Centered Research Outcomes Institute. The authors report no conflicts of interest. Three themes related to medical treatment and symptom management arose from analyses - (1) an emotional response to LSS; (2) a desire for education about LSS and motivation to pursue education from any available source; and (3) a desire for individualized care based on self
Fales, Jessica; Palermo, Tonya M; Law, Emily F; Wilson, Anna C
Sleep disturbances are commonly reported in youth with chronic pain. We examined whether online cognitive-behavioral therapy (CBT) for pain management would impact youth's sleep. Subjective sleep quality and actigraphic sleep were evaluated in 33 youth (M = 14.8 years; 70% female) with chronic pain participating in a larger randomized controlled trial of online-CBT. The Internet treatment condition (n = 17) received 8-10 weeks of online-CBT + standard care, and the wait-list control condition (n = 16) continued with standard care. Although pain improved with online-CBT, no changes were observed in sleep outcomes. Shorter pretreatment sleep duration was associated with less improvement in posttreatment functioning. Findings underscore the need for further development in psychological therapies to more intensively target sleep loss in youth with chronic pain.
Blau, Peter M.
High salaries, specialized academic departments, and academic tradition facilitate faculty and student recruitment. Large institutions meet these criteria with greater ease than small, although size does act as an impediment. Particularistic preferences do exercise some influences on the overall recruitment picture. (JH)
Picillo, Marina; Kou, Nancy; Barone, Paolo; Fasano, Alfonso
Enrollment of an adequate number of suitable candidates is a critical component of good quality randomized controlled trials (RCTs). Parkinson's disease (PD) is a highly heterogeneous disease and recruiting a large and homogeneous sample of patients is often challenging. Further, PD patients are often elderly, cognitively impaired and disabled, thus requiring the assistance from their caregivers for participation in RCTs. Only a limited number of studies have explored the effectiveness of recruitment strategies and PD patient selection in clinical trials. We aim to review the four crucial recruitment components of RCTs (i.e. infrastructure, nature of the research, recruiter characteristics and participant characteristics) with particular implications in PD, and to explore strategies to improve recruitment and patient selection in RCTs in PD. Movement disorders centers have a key role in managing recruitment and patient selection in RCTs in PD. Key recommendations within the infrastructure component are to improve trust and communication between patient and participant, and to consider the diversity, perceived disadvantages, and health care accessibility of the participants. Further, study designs that involve participant's opinions and considers placebo and lessebo effects are highly recommended for the nature of the research component of RCTs. Finally, a team-based approach with recruiters and participants that establishes relationships between researchers and the community and addresses ethical considerations are encouraged as part of the recruiters and participants components. Finally, we envisage a greater usage of internet-based strategies for clinical trials recruitment in PD with the goal of 'going viral' with the recruitment. Copyright © 2015 Elsevier Ltd. All rights reserved.
Vozdolska, Ralitza; Sano, Mary; Aisen, Paul; Edland, Steven D
Increasing the proportion of subjects allocated to the experimental treatment in controlled clinical trials is often advocated as a method of increasing recruitment rates and improving the performance of trials. The presumption is that the higher likelihood of randomization to the experimental treatment will be perceived by potential study enrollees as an added benefit of participation and will increase recruitment rates and speed the completion of trials. However, studies with alternative allocation ratios require a larger sample size to maintain statistical power, which may result in a net increase in time required to complete recruitment and a net increase in total trial cost. To describe the potential net effect of alternative allocation ratios on recruitment time and trial cost. Models of recruitment time and trial cost were developed and used to compare trials with 1:1 allocation to trials with alternative allocation ratios under a range of per subject costs, per day costs, and enrollment rates. In regard to time required to complete recruitment, alternative allocation ratios are net beneficial if the recruitment rate improves by more than about 4% for trials with a 1.5:1 allocation ratio and 12% for trials with a 2:1 allocation ratio. More substantial improvements in recruitment rate, 13 and 47% respectively for scenarios we considered, are required for alternative allocation to be net beneficial in terms of tangible monetary cost. The cost models were developed expressly for trials comparing proportions or means across treatment groups. Using alternative allocation ratio designs to improve recruitment may or may not be time and cost-effective. Using alternative allocation for this purpose should only be considered for trial contexts where there is both clear evidence that the alternative design does improve recruitment rates and the attained time or cost efficiency justifies the added study subject burden implied by a larger sample size.
Treweek, Shaun; Pitkethly, Marie; Cook, Jonathan; Fraser, Cynthia; Mitchell, Elizabeth; Sullivan, Frank; Jackson, Catherine; Taskila, Tyna K; Gardner, Heidi
Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. To quantify the effects of strategies for improving recruitment of participants to randomised trials. A secondary objective is to assess the evidence for the effect of the research setting (e.g. primary care versus secondary care) on recruitment. We searched the Cochrane Methodology Review Group Specialised Register (CMR) in the Cochrane Library (July 2012, searched 11 February 2015); MEDLINE and MEDLINE In Process (OVID) (1946 to 10 February 2015); Embase (OVID) (1996 to 2015 Week 06); Science Citation Index & Social Science Citation Index (ISI) (2009 to 11 February 2015) and ERIC (EBSCO) (2009 to 11 February 2015). Randomised and quasi-randomised trials of methods to increase recruitment to randomised trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. We excluded studies aiming to increase response rates to questionnaires or trial retention and those evaluating incentives and disincentives for clinicians to recruit participants. We extracted data on: the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used a risk difference to estimate the absolute improvement and the 95% confidence interval (CI) to describe the effect in individual trials. We assessed heterogeneity between trial results. We used GRADE to judge the certainty we had in the evidence coming from each comparison. We identified 68 eligible trials (24 new to this update) with more than 74,000 participants. There were 63 studies involving interventions aimed directly at trial participants, while five evaluated interventions aimed at people recruiting participants. All studies were in
Luo, Jake; Chen, Weiheng; Wu, Min; Weng, Chunhua
Prior studies of clinical trial planning indicate that it is crucial to search and screen recruitment sites before starting to enroll participants. However, currently there is no systematic method developed to support clinical investigators to search candidate recruitment sites according to their interested clinical trial factors. In this study, we aim at developing a new approach to integrating the location data of over one million heterogeneous recruitment sites that are stored in clinical trial documents. The integrated recruitment location data can be searched and visualized using a map-based information retrieval method. The method enables systematic search and analysis of recruitment sites across a large amount of clinical trials. The location data of more than 1.4 million recruitment sites of over 183,000 clinical trials was normalized and integrated using a geocoding method. The integrated data can be used to support geographic information retrieval of recruitment sites. Additionally, the information of over 6000 clinical trial target disease conditions and close to 4000 interventions was also integrated into the system and linked to the recruitment locations. Such data integration enabled the construction of a novel map-based query system. The system will allow clinical investigators to search and visualize candidate recruitment sites for clinical trials based on target conditions and interventions. The evaluation results showed that the coverage of the geographic location mapping for the 1.4 million recruitment sites was 99.8%. The evaluation of 200 randomly retrieved recruitment sites showed that the correctness of geographic information mapping was 96.5%. The recruitment intensities of the top 30 countries were also retrieved and analyzed. The data analysis results indicated that the recruitment intensity varied significantly across different countries and geographic areas. This study contributed a new data processing framework to extract and integrate
Owino, Fredrick; Mandala, Justin; Ambia, Julie; Agot, Kawango; Van Damme, Lut
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. PMID:24353443
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
Full Text Available Abstract Background To assess bias and generalizability of results in randomized controlled trials (RCT, investigators compare participants to non-participants or early- to late-participants. Comparisons can also inform the recruitment approach, especially when working with challenging populations, such as urban adolescents. In this paper, we describe characteristics by participant status of urban teens eligible to participate in a RCT of a school-based, web-based asthma management program. Methods The denominator for this analysis was all students found to be eligible to participate in the RCT. Data were analyzed for participants and non-participants of the RCT, as well as for students that enrolled during the initially scheduled recruitment period (early-participants and persons that delayed enrollment until the following fall when recruitment was re-opened to increase sample size (late-participants. Full Time Equivalents (FTEs of staff associated with recruitment were estimated. Results Of 1668 teens eligible for the RCT, 386 enrolled early, and 36 enrolled late, leaving 1246 non-participants. Participants were younger (p Conclusions Recruitment messages attracted youth with moderate-to-severe asthma, but extending enrollment was costly, resulting in potentially less motivated, and certainly less compliant, participants. Investigators must balance internal versus external validity in the decision to extend recruitment. Gains in sample size and external validity may be offset by the cost of additional staff time and the threat to internal validity caused by lower participant follow-up. Trial Registration ClinicalTrials.gov: NCT00201058
Family intervention for co-occurring substance use and severe psychiatric disorders: participant characteristics and correlates of initial engagement and more extended exposure in a randomized controlled trial.
Mueser, Kim T; Glynn, Shirley M; Cather, Corinne; Zarate, Roberto; Fox, Lindy; Feldman, James; Wolfe, Rosemarie; Clark, Robin E
Clients with severe mental illness and substance use disorder (i.e., dual disorders) frequently have contact with family members, who may provide valuable emotional and material support, but have limited skills and knowledge to promote recovery. Furthermore, high levels of family conflict and stress are related to higher rates of relapse. The present study was a two-site randomized controlled trial comparing a comprehensive, behaviorally-based family intervention for dual disorders program (FIDD) to a shorter-term family psychoeducational program (FPE). The modal family was a single male son in his early 30s diagnosed with both alcohol and drug problems and a schizophrenia-spectrum disorder participating with his middle-aged mother, with whom he lived. Initial engagement rates following consent to participate in the study and the family intervention programs were moderately high for both programs (88% and 84%, respectively), but rates of longer term retention and exposure to the core elements of each treatment model were lower (61% and 55%, respectively). Characteristics of the relatives were the strongest predictors of successful initial engagement in the family programs with the most important predictor being relatives who reported higher levels of benefit related to the relationship with the client. Subsequent successful exposure to the family treatment models was more strongly associated with client factors, including less severity of drug abuse and male client gender. The results suggest that attention to issues of motivating relatives to participate in family intervention, and more focused efforts to address the disruptive effects of drug abuse on the family could improve rates of engagement and retention in family programs for dual disorders.
Penney, Lisa M; Borman, Walter C; Bearden, Ronald M
.... the students were administered a trial predictor battery while at the school, and performance ratings and production data were collected after participants had been assigned to recruiting duty...
Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study Desafios no recrutamento, presença e adesão ao protocolo de intervenção em um ensaio controlado aleatorizado com sobreviventes de AVE agudo no Brasil: um estudo de viabilidade
Full Text Available BACKGROUND: There is a high demand for stroke rehabilitation in the Brazilian public health system which should make undertaking clinical trials straightforward. OBJECTIVES: The aims of this study were to 1 determine the rate of recruitment of community-dwelling stroke survivors into a randomized trial of the effects of strength training in addition to task-specific gait training, 2 compare the effectiveness of various recruitment strategies on accrual rates, and 3 determine the attendance at training sessions and adherence to the intervention protocol. METHODS: Participants within six months of a stroke were screened for eligibility and invited to participate. Recruitment strategies were classified as advertisement or referral. The number of people who were screened, eligible and recruited for each strategy was recorded. Attendance at training sessions and adherence to the intervention protocol were recorded. RESULTS: Over the first 14 months, 150 stroke survivors were screened, 10 were recruited, and 35 (23% were eligible. Twenty-five of these patients (71% were unable to participate with lack of transport given as the most common reason. The most successful strategy was referral via hospital-based physical therapists (50%. Overall attendance was 72% with lack of transport being the most common reason for non-attendance. Overall adherence to the protocol was 97% with feeling unwell being the most common reason for non-adherence. CONCLUSIONS: Recruitment of stroke survivors was inefficient. Lack of transport was the most common barrier to participate in and attend training sessions. Funding for transport is essential to make carrying out trials in Brazil feasible. Trial Registration ACTRN12609000803291.CONTEXTUALIZAÇÃO: O sistema de saúde pública no Brasil apresenta uma alta demanda para a reabilitação de indivíduos após acidente vascular encefálico (AVE. Consequentemente, a condução de ensaios clínicos com essa população deveria
McIntosh, Scott; Ossip-Klein, Deborah J; Hazel-Fernandez, Leslie; Spada, Jean; McDonald, Paul W; Klein, Jonathan D
Physician office settings play an important role in tobacco cessation intervention. However, few tobacco cessation trials are conducted at these sites, in part because of the many challenges associated with recruiting community physician offices into research. The present study identified and implemented strategies for recruiting physician offices into a randomized clinical trial of tobacco screening and cessation interventions with adolescent patients. A total of 30 community physicians participated in focus groups to elicit their perceptions of facilitators of and barriers to initial engagement of physician practices and the subsequent enrollment of the practices in long-term research projects. Physicians identified facilitators such as (a) the involvement of office staff in the recruitment process and (b) on-site presentations of the study's background and aims. Some of the barriers identified were time commitment concerns and the lack of incentives in exchange for participation. These focus group findings were then integrated with theory-based and empirically driven recruitment strategies for a 12-month randomized tobacco intervention trial with adolescent patients. Of 185 office practices approached to participate (screened from a pool of 273 practices), 103 agreed to on-site presentations of the study. Subsequently, almost all of the practices (101) that received the presentation agreed to enroll in the study. Conclusions are that (a) recruitment is a multicomponent process, (b) the processes of communication, engagement, and enrollment must be carefully planned and implemented to achieve maximal results, and (c) the development of effective strategies for recruiting health care provider practices presents an important infrastructure for testing adolescent smoking cessation interventions.
Peckham, Emily; Arundel, Catherine; Bailey, Della; Callen, Tracy; Cusack, Christina; Crosland, Suzanne; Foster, Penny; Herlihy, Hannah; Hope, James; Ker, Suzy; McCloud, Tayla; Romain-Hooper, Crystal-Bella; Stribling, Alison; Phiri, Peter; Tait, Ellen; Gilbody, Simon
Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations. SCIMITAR+ is a multi-centre pragmatic two-arm parallel-group RCT, which aimed to recruit 400 participants with severe mental ill health who smoke and would like to cut down or quit. The study recruited primarily in secondary care through community mental health teams and psychiatrists with a smaller number of participants recruited through primary care. Recruitment opened in October 2015 and closed in December 2016, by which point 526 participants had been recruited. We gathered information from recruiting sites on strategies which led to the successful recruitment in SCIMITAR+ and in this article present our approach to trial management along with the strategies employed by the recruiting sites. Alongside having a dedicated trial manager and trial management team, we identified three main themes that led to successful recruitment. These were: clinicians with a positive attitude to research; researchers and clinicians working together; and the use of NHS targets. The overriding theme was the importance of relationships between both the researchers and the recruiting clinicians and the recruiting clinicians and the participants. This study makes a significant contribution to the limited evidence base of real-world cases of successful recruitment to RCTs and offers practical guidance to those planning and conducting trials. Building positive relationships between clinicians, researchers and participants is crucial to successful recruitment.
Marcano Belisario, José S; Bruggeling, Michelle N; Gunn, Laura H; Brusamento, Serena; Car, Josip
Tobacco control is a top public health priority around the globe due to the high prevalence of cigarette smoking and its associated morbidity and mortality. Much effort has been focused on establishing the effectiveness of different smoking cessation strategies. This review, however, aims to address the initial challenge faced by smoking cessation programmes: recruitment of smokers. The primary objective of this review was to determine the effectiveness of different strategies for recruiting smokers into cessation programmes. The secondary objective was to determine the impact that these strategies had on smoking cessation rates at least six months after enrolment into a cessation programme. We searched the specialised register of the Cochrane Tobacco Addiction Group using a search strategy which included the terms ('recruit$', 'invit$', 'enter', 'entry', 'enrolment') combined with ('smok$', 'cigarette', 'smoking cessation', 'tobacco') in the title, abstract or keyword fields. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), and registers of current and ongoing trials. We also searched the reference lists of included studies. We included randomised controlled trials and cluster randomised controlled trials that compared at least two different methods of recruiting current smokers into a smoking cessation programme. We also included those studies which focused on the effectiveness of a smoking cessation programme as long as the study involved multiple recruitment methods and reported results of the recruitment phase. From each included study, we extracted data on the type of participants, type of recruitment strategies (i.e., setting, mode of communication used, intensity and duration) and comparisons, and on randomisation, allocation concealment, and blinding procedures.Our primary outcome was the proportion of smokers successfully recruited to each cessation programme compared to alternative modalities of recruitment. Our
Thornton, Louise K; Harris, Keith; Baker, Amanda L; Johnson, Martin; Kay-Lambkin, Frances J
This study aimed to examine the feasibility of recruiting participants to addiction research via Facebook. Participants were recruited via an advertisement on Facebook, a local research register and university psychology courses. Participants completed a self-report survey regarding substance use, history of mental health issues and current psychological distress. The 524 participants recruited via Facebook cost $1.86 per participant; and 418 participants were recruited via more traditional methods. There were significantly fewer women in the Facebook sample compared with the non-Facebook sample (χ(2) = 196.61, P Facebook participants reported current use of tobacco (women: Facebook = 57%, non-Facebook = 21%, χ(2) = 39.71, P Facebook = 62%, non-Facebook = 21%, χ(2) = 32.429, P Facebook = 26%, non-Facebook = 7%, χ(2) = 14.364, P Facebook = 46%, non-Facebook = 24%, χ(2) = 6.765, P Facebook sample contained a higher percentage of high-severity cannabis users (women: Facebook = 24%, non-Facebook = 4%, χ(2) = 18.12, P Facebook = 43%, non-Facebook = 16%, χ(2) = 10.00, P Facebook, we were able to capture a greater proportion of people with high-severity substance use and mental health issues and were able to capture a greater and more severe range of substance use behaviours. This suggests social networking sites are efficient, cost-effective ways to recruit large numbers of participants, with relevant behaviours and conditions, to addiction research. [Thornton LK, Harris K, Baker AL, Johnson M, Kay-Lambkin FJ. Recruiting for addiction research via Facebook. Drug Alcohol Rev 2016;35:494-502]. © 2015 Australasian Professional Society on Alcohol and other Drugs.
Li, Guowei; Hopkins, Robert B; Levine, Mitchell A H; Jin, Xuejing; Bowen, James M; Thabane, Lehana; Goeree, Ron; Fedorko, Ludwik; O'Reilly, Daria J
To investigate the effect of hyperbaric oxygen therapy on health-related quality of life (HRQoL) in participants with diabetes and chronic foot ulcers. Using data from a randomized controlled trial, we included 103 participants (49 in hyperbaric oxygen therapy group and 54 in sham group) for analyses. The primary outcome was HRQoL as measured by the EQ-5D-3L instrument, while secondary outcomes included quality of life evaluated by the Short Form 36 (SF-36) and Diabetic Foot Ulcers Scale-Short Form (DFS-SF). We used the analysis of covariance to assess whether the EQ-5D index values in hyperbaric oxygen therapy group differed from the sham group. Logistic regression was used to assess the relationship between hyperbaric oxygen therapy and the responses of 'problems' for the EQ-5D health states. No significant differences in EQ-5D index values were found between the hyperbaric oxygen therapy and sham groups: 0.01 (95% CI -0.25, 0.28; p = 0.93) at week 12; 0.07 (95% CI -0.21, 0.34; p = 0.64) at week 6. Hyperbaric oxygen therapy was found to be associated with fewer participants reporting 'problems' in mobility (OR 0.24, 95% CI 0.07, 0.85 at week 12) and pain or discomfort (OR 0.20, 95% CI 0.07, 0.61 at week 6; OR 0.32, 95% CI 0.11, 0.97 at week 12), compared with the sham group. No significant differences in SF-36 or DFS-SF were observed. No significant effect of hyperbaric oxygen therapy on HRQoL measured by EQ-5D index value was found in this study. Due to the potential insufficient power to assess statistical difference, more large-scale research is needed to further evaluate the effect of hyperbaric oxygen therapy on HRQoL in participants with chronic diabetic foot ulcers.
The Human Resources Department switches to electronic recruitment. From now on whenever you are involved in a recruitment action you will receive an e-mail giving you access to a Web folder. Inside you will find a shortlist of applications drawn up by the Human Resources Department. This will allow you to consult the folder, at the same time as everyone else involved in the recruitment process, for the vacancy you are interested in. This new electronic recruitment system, known as e-RT, will be introduced in a presentation given at 10 a.m. on 11 February in the Main Auditorium. Implemented by AIS (Administrative Information Services) and the Human Resources Department, e-RT will cover vacancies open in all of CERN's recruitment programmes. The electronic application system was initially made available to technical students in July 2003. By December it was extended to summer students, fellows, associates and Local Staff. Geraldine Ballet from the Recruitment Service prefers e-RT to mountains of paper! The Hu...
Go, Ho-Yeon; Lee, Ju Ah; Park, Sunyoung; Park, Sunju; Park, Jeong-Su; Cheon, Chunhoo; Ko, Seong-Gyu; Kong, Kyung-Hwan; Jun, Chan-yong; Park, Jong-hyeong; Shin, Mi-Ran; Lee, Se-Hoon
To evaluate the efficacy, safety, satisfaction, discomfort and patient preference of moxa cones of artemisia vulgaris and charcoal moxa. This comparative study of moxibustion treatment with Artemisia vulgaris and charcoal moxa cone stimulating Zhongwan (CV 12) is a cross-over single-blinded, randomized clinical trial. A total of 40 healthy subjects (24 males and 16 females) participated in this study. Two subjects dropped out of the trial. Thirty-eight subjects were treated with Artemisia vulgaris and charcoal moxa cones for 30 min in a cross-over design. After treatment, the patients underwent a 30 minute waiting period, and then the temperatures at Tanzhong (CV 17), Zhongwan (CV 12) and Guanyuan (CV 4) were measured using digital infrared thermal imaging. After the use of Artemisia vulgaris moxa, the patients' body temperatures were slightly lowered at Tanzhong (CV 17), Zhongwan (CV 12) and Guanyuan (CV 4), but the changes were not statistically significant. After the use of charcoal moxa, the patients' body temperatures were somewhat increased at Zhongwan (CV 12) and Guanyuan (CV 4), but the changes were not statistically significant. After Artemisia vulgaris moxa use, the body temperature difference between Zhongwan (CV 12) and Guanyuan (CV 4) was significantly increased. After charcoal moxa use, the body temperature difference between Tanzhong (CV 17) and Zhongwan (CV 12) was significantly decreased in males and in the whole group. This change was caused by the difference in the moxibustion type and by gender differences. This pilot study found that moxibustion did not raise the body temperature, but temperature differences between acupoints were affected. Further large-scale randomized controlled trials are needed for the effect of moxibustion on body temperature.
Kellar, I; Mann, E; Kinmonth, A L; Prevost, A T; Sutton, S; Marteau, T M
To test whether information about benefits and harms of screening for type 2 diabetes increases intentions to make lifestyle changes amongst attenders, predominantly among the socially advantaged and those with a strong future time orientation. Planned subgroup analysis of attenders for screening participating in a randomized controlled trial of an informed choice invitation vs a standard invitation to attend for type 2 diabetes screening. Potentially eligible participants were identified from practice registers using routine data which were used to calculate risk scores for diabetes for all aged 40-69 years without known type 2 diabetes and area deprivation based on post code. In total, 1272 individuals in the top 25% risk category were randomized to receive one of two invitations to attend their practices for screening: an informed choice invitation or a standard invitation. The subsequent attenders completed self-report measures of future time orientation and deprivation immediately before undergoing a screening test. Individual-level deprivation demonstrated a significant moderator effect [F (4,635) = 4.32, P = 0.002]: individuals who were high in deprivation had lower intentions to engage in lifestyle change following receipt of the informed choice invitation. However, intentions were not patterned by deprivation when it was assessed at the area-level using the Index of Multiple Deprivation 2007. The hypothesized moderating effect of future time orientation on invitation type was also supported [F(14,613) = 2.46, P = 0.002): individuals low in future time orientation had markedly lower intentions to engage in lifestyle change following receipt of an informed choice invitation compared with a standard invitation for screening. Efforts to enhance informed choice where the implications of diagnosis are a requirement for lifestyle change may require that the immediate benefits are communicated, and efforts to address the apparent barriers to diabetes self
Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebæk, Camilla
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
Roy-Ghanta, Sumita; Van der Most, Robbert; Li, Ping; Vaughn, David W
Prior receipt of a trivalent seasonal influenza vaccine (TIV) can affect hemagglutination inhibition (HI) antibody responses to pandemic influenza vaccines. We investigated the effect of TIV priming on humoral responses to AS03-adjuvanted and nonadjuvanted A(H1N1)pdm09 vaccines, the role of AS03 on cell-mediated immune (CMI) responses, and vaccine safety. Healthy adults (aged 19-40 years) were randomized 1:1:1:1 to receive TIV or saline followed 4 months later by 2 doses, 3 weeks apart, of adjuvanted or nonadjuvanted A(H1N1)pdm09 vaccine and followed up to study end (day 507). Pre- and postvaccination responses of HI and neutralizing antibody, CD4(+)/CD8(+) T cells, memory B cells, and plasmablasts were assessed. Ninety-nine of the 133 participants enrolled completed the study. No vaccine-related serious adverse events were recorded. In TIV-primed participants, A(H1N1)pdm09-specific antibody and CD4(+) T-cell and memory B-cell responses to the pandemic vaccine tended to be diminished. Vaccine adjuvantation led to increased responses of vaccine-homologous and -heterologous HI and neutralizing antibodies and CD4(+) T cells, homologous memory B cells, and plasmablasts. In healthy adults, prior TIV administration decreased humoral and CMI responses to A(H1N1)pdm09 vaccine. Adjuvantation of A(H1N1)pdm09 antigen helped to overcome immune interference between the influenza vaccines. No safety concerns were observed. Clinical Trials.gov identifier NCT00707967. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
Würtzen, Hanne; Dalton, Susanne Oksbjerg; Andersen, Klaus Kaae; Elsass, Peter; Flyger, Henrik Lavlund; Sumbundu, Antonia; Johansen, Christoffer
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 < 0.001) and have a less recent diagnosis at invitation than decliners (N = 872; p < 0.001). After adjustment for age and time since diagnosis at invitation, a statistically significant difference was also found between the two groups in use of psychologist sessions (p < 0.05), whereas neither breast cancer variables nor co-morbidity was significantly different. Self-reported data obtained by use of validated psychometric scales from 169 decliners and 336 women who agreed to enroll in the trial showed 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.
Ingersgaard, Marianne Vie; Tulstrup, Morten; Schmiegelow, Kjeld; Larsen, Hanne Baekgaard
To explore parents' and adolescents' motives for accepting/declining participation in the ALL2008 trials and adolescents' involvement in the decision-making process. Children and adolescents with acute lymphoblastic leukaemia treated on the Nordic Society of Paediatric Haematology and Oncology ALL2008 protocol were eligible for two randomizations testing 6-mercaptopurine treatment intensifications to improve efficacy and Asparaginase de-escalation to reduce toxicity. We recently reported that while adolescents favoured treatment reduction, parents of young children favoured treatment intensification. A qualitative, exploratory study. A maximum variation sampling strategy was used. Five adolescents aged 12-17 years, six parents of adolescents and five parents of children aged 1-12 years were interviewed in the period March-May 2015. Data were analysed using content analysis. 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 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 of a negative outcome induced fear of decisional regret and distress by the parents, yet they invested considerable trust in the physician's expertise. Our findings highlight the importance of adolescents' active involvement in consent conferences. Research on management of disagreements between adolescents and parents in trial decisions is needed. © 2017 John Wiley & Sons Ltd.
Holscher, Hannah D; Bauer, Laura L; Gourineni, Vishnupriya; Pelkman, Christine L; Fahey, George C; Swanson, Kelly S
Prebiotics resist digestion, providing fermentable substrates for select gastrointestinal bacteria associated with health and well-being. Agave inulin differs from other inulin type fibers in chemical structure and botanical origin. Preclinical animal research suggests these differences affect bacterial utilization and physiologic outcomes. Thus, research is needed to determine whether these effects translate to healthy adults. We evaluated agave inulin utilization by the gastrointestinal microbiota by measuring fecal fermentative end products and bacterial taxa. A randomized, double-blind, placebo-controlled, 3-period, crossover trial was undertaken in healthy adults (n = 29). Participants consumed 0, 5.0, or 7.5 g agave inulin/d for 21 d with 7-d washouts between periods. Participants recorded daily dietary intake; fecal samples were collected during days 16-20 of each period and were subjected to fermentative end product analysis and 16S Illumina sequencing. Fecal Actinobacteria and Bifidobacterium were enriched (P inulin/d, respectively, compared with control. Desulfovibrio were depleted 40% with agave inulin compared with control. Agave inulin tended (P inulin (g/kcal) and Bifidobacterium (r = 0.41, P inulin/d) per kilocalorie was positively associated with fecal butyrate (r = 0.30, P = 0.005), tended to be positively associated with Bifidobacterium (r = 0.19, P = 0.08), and was negatively correlated with Desulfovibrio abundance (r = -0.31, P = 0.004). Agave inulin supplementation shifted the gastrointestinal microbiota composition and activity in healthy adults. Further investigation is warranted to determine whether the observed changes translate into health benefits in human populations. This trial was registered at clinicaltrials.gov as NCT01925560. © 2015 American Society for Nutrition.
Shah, Meena; Bouza, Brooke; Adams-Huet, Beverley; Jaffery, Manall; Esposito, Phil; Dart, Lyn
The effect of menu labels on food choices is unknown in Hispanics. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics. 372 Hispanics (18-65 years) were randomly assigned to menus with no labels (NL) (n=127), rank-ordered calorie labels plus a statement on energy needs per meal (CL) (n=123), or rank-ordered exercise labels showing minutes of brisk walking necessary to burn the food calories (EL) (n=122). The menus had identical food choices. Participants were instructed to select foods from the assigned menu as if having lunch in a fast food restaurant. One-way analysis of variance found no difference in calories ordered (median (25th and 75th centiles)) by menu condition (NL: 785.0 (465.0, 1010.0) kcal; CL: 790.0 (510.0, 1020.0) kcal; EL: 752.5 (520.0, 1033.8) kcal; p=0.75). Calories from specific foods and macronutrient intake were not different by menu condition. Menu label use was 26.8% in the CL and 25.4% in the EL condition. Calories ordered were not different between those who used and those who did not use the labels. Regression analysis showed that perception of being overweight (p=0.02), selecting foods based on health value (pcalories ordered. Logistic regression showed that selecting foods based on health value (p=0.01) was associated with higher food label use. Menu labels did not affect food choices in Hispanic participants. Future studies should determine if nutrition, exercise, and weight perception counseling prior to menu labels intervention would result in better food choices. NCT02804503; post-results. Copyright © 2016 American Federation for Medical Research.
Recruitment of a large and reliable control group is a challenge in psychological survey based research. The effect of recruitment styles and age on response-rate, data quality, and individual differences were investigated in a control group for a postal survey of elderly bereaved people....... This study was a direct reaction to the first recruitment attempt that had a 10% response rate. This study consisted of four groups of randomly selected elderly married people (65-81 years) receiving a postal questionnaire measuring depression, social support, coping style, adult attachment, life...... incentive had the highest response-rate (51%), good data quality, and no sampling bias in individual differences. This method can be highly recommended in future control group recruitment....
Yancey, A K; Miles, O L; McCarthy, W J; Sandoval, G; Hill, J; Leslie, J J; Harrison, G G
To assess patterns of recruitment into a community-based NCI-funded physical activity and dietary lifestyle change program targeting African-American women. Acquisition of a convenience sample to be screened for participation in a randomized, controlled prevention intervention. African-American-owned and -operated health club located in an area of Los Angeles in which African Americans are concentrated. 893 African-American women. RECRUITMENT STRATEGIES: Social networking/word-of-mouth, staff presentations, mass and targeted media, and physician referral. Completion of screening questionnaire indicating a desire to enroll in the study. Screening questionnaire domains included self-reported height and weight, recent participation in organized weight loss programs, ability to walk one mile unassisted, current medication use, smoking status, personal medical history of cancer, sociodemographic variables, and recruitment source. Sociodemographic and anthropometric characteristics distinguished between respondents obtained through different recruitment strategies. In particular, women with a higher body mass index (BMI) were more likely than those with lower BMIs (P = .014) to be recruited through more personalized methods (eg, social networking). Culturally tailored recruitment strategies are critical in securing the participation of members of "hard-to-reach" populations, who are both under-represented in health promotion research and at high risk for chronic diseases.
Hare, Kristoffer B; Lohmander, L Stefan; Roos, Ewa M.
BACKGROUND: Randomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics. Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo...... component only adds to this complexity. The purpose of this study was to report the challenges of recruiting patients into an orthopedic placebo-controlled surgical trial, to determine the number of patients needed to be screened and allocated in order to include one participant into the trial...... in an orthopedic placebo-controlled surgical trial. Oral information given by the surgeon to the patient and the contribution to research are important aspects to enhance patient recruitment. TRIAL REGISTRATION: ClinicalTrials.gov NCT01264991, registered 21 December 2010....
Thrul, Johannes; Stemmler, Mark; Goecke, Michaela; Bühler, Anneke
Even though many adolescent smokers want to quit, it is difficult to recruit them into smoking cessation interventions. Little is known about which adolescent smokers are currently reached by these measures. In this study we compare participants of a group-based, cognitive behavioral smoking cessation intervention with adolescent smokers who decided against participating. Within a non-randomized controlled trial, data of 1053 smokers (aged 11-19) from 42 German secondary schools were analyzed. Of these smokers, 272 were recruited into 47 courses of the intervention. An in-class information session, individually addressing potential participants, and incentives were used as means of recruitment. Personal predictors of participation were analyzed using regression analyses and multivariate path analyses to test for mediation. In the path analysis model, nicotine dependence, quit motivation, and a previous quit attempt were directly positively related to participation. Heavier smoking behavior was indirectly positively associated with participation through nicotine dependence and negatively through quit motivation, yielding an overall positive indirect effect. The positive effect of a previous quit attempt on participation was partially mediated through nicotine dependence and quit motivation. The proportion of smoking friends were indirectly positively related to participation, mediated through nicotine dependence. Since adolescents with heavier smoking behavior and stronger nicotine dependence are less likely to undertake a successful unassisted quit attempt, the reach of these young smokers with professional cessation interventions is desirable. Further measures to improve the recruitment of those currently not motivated to quit have to be examined in future studies. Copyright © 2015 Elsevier Ltd. All rights reserved.
Cameron, D; Spence, M
As the first phase of a project designed to institute controlled drinking as a therapeutic goal for alcoholics, it was decied to recruit volunteers who were dissatisfied with their present mode of drinking but who had not previously sought help. This was done by requesting them to phone a private number. When these volunteers had been recruited it was proposed to modify their drinking habits to their own requirements, using non-averse training, drinking practice and ongoing group psychotherapy. This project however has not been implemented because of paucity of volunteers. The methods of recruitement are listed and those drinkers who volunteered are described. The reasons for the low rate of response are discussed.
Kye, Steve H; Tashkin, Donald P; Roth, Michael D; Adams, Bradley; Nie, Wen-Xian; Mao, Jenny T
The ability to recruit qualified subjects who are willing to adhere to the study protocol in clinical trials is an essential component of translational research. Such tasks can be particularly challenging for chemoprevention studies when the targeted study population is healthy, at risk individuals who do not have signs or symptoms of the disease, and the study participation involves complex scheduling and invasive procedures such as bronchoscopy. In this report, we describe the recruitment process and evaluated the effectiveness of various recruitment strategies utilized in our National Cancer Institute sponsored lung cancer chemoprevention study with celecoxib. Heavy ex-smokers were recruited into the study through various methods such as radio advertisements, print media, mass mailings, flyers, internet postings and others. The number of inquiries, on-site screenees and randomization generated by each method determined the efficacy of that recruitment strategy. We prescreened 4470 individuals, invited 323 people for on-site screening and randomized 137 subjects. Radio advertisements (ads) generated the most inquiries (71.1%), followed by internet posting (11.8%), print media (6.0%), posted and racked flyers (4.4%), mass mailings (2.7%) and other strategies such as referrals from friends or family members or health care providers (2.3%). Radio ads, although costly, yielded the most subjects for on-site screening and randomization. Moreover, among the various types of radio stations, news radio stations were by far the most successful. Our results suggest that advertising on news radio is a highly effective recruitment method for successful accrual of ex-smokers into lung cancer chemoprevention trials.
Adams Robert J
Full Text Available Abstract Background Analysis was undertaken on data from randomly selected participants of a bio-medical cohort study to assess representativeness. The research hypotheses was that there was no difference in participation and non-participations in terms of health-related indicators (smoking, alcohol use, body mass index, physical activity, blood pressure and cholesterol readings and overall health status and selected socio-demographics (age, sex, area of residence, education level, marital status and work status. Methods Randomly selected adults were recruited into a bio-medical representative cohort study based in the north western suburbs of the capital of South Australia – Adealide. Comparison data was obtained from cross-sectional surveys of randomly selected adults in the same age range and in the same region. The cohort participants were 4060 randomly selected adults (18+ years. Results There were no major differences between study participants and the comparison population in terms of current smoking status, body mass index, physical activity, overall health status and proportions with current high blood pressure and cholesterol readings. Significantly more people who reported a medium to very high alcohol risk participated in the study. There were some demographic differences with study participants more likely to be in the middle level of household income and education level. Conclusion People with risky behaviours participated in this health study in the same proportions as people without these risk factors.
Hapca, Adrian; Jennings, Claudine G; Wei, Li; Wilson, Adam; MacDonald, Thomas M; Mackenzie, Isla S
To measure the impact of newspaper advertising across Scotland on patient interest, and subsequent recruitment into the Standard Care vs. Celecoxib Outcome Trial (SCOT), a clinical trial investigating the cardiovascular safety of non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis. Newspaper advertisements about the SCOT trial were placed sequentially in regional and national Scottish newspapers. The number of phone calls as a result of exposure to the advertisements and ongoing study recruitment rates were recorded before, during and after the advertising campaign. To enroll in SCOT individuals had to be registered with a participating GP practice. The total cost for the advertising campaign was £46 250 and 320 phone calls were received as a result of individuals responding to the newspaper advertisements. One hundred and seventy-two individuals were identified as possibly suitable to be included in the study. However only 36 were registered at participating GP practices, 17 completed a screening visit and 15 finally were randomized into the study. The average cost per respondent individual was £144 and the average cost per randomized patient was £3083. Analysis of recruitment rate trends showed that there was no impact of the newspaper advertising campaign on increasing recruitment into SCOT. Advertisements placed in local and national newspapers were not an effective recruitment strategy for the SCOT trial. The advertisements attracted relatively small numbers of respondents, many of whom did not meet study inclusion criteria or were not registered at a participating GP practice. © 2013 The British Pharmacological Society.
Sánchez Legaza, E; Ciges Juan, M; González Pérez, M; Miranda Caravallo, J I
Presbycusis is characterised by a sensorineural hearing loss, mainly in high frequencies, symmetrical and progressive and poor understanding. Recuritment, typical in cochlear hearing loss, would be present in cases of sensorial presbycusis which runs mainly in cochlear pathologies. We analyse variables and their possible interrelations with recruitment in 241 presbycusic patients.
Andreae, Susan J; Halanych, Jewell H; Cherrington, Andrea; Safford, Monika M
We are conducting a community-based cluster-randomized trial in rural Alabama, testing a peer-support intervention designed to improve diabetes self-care behaviors. We describe recruitment and data collection approaches used, focusing on strategies that created community partnerships and facilitated recruitment in underserved, rural, largely minority communities. Key recruitment and data collection strategies included early community engagement; pilot testing of procedures; inclusion of community members as study team members, recruiters, and data collectors; data collection at community venues to minimize participant travel requirements; and provision of a multi-disciplinary diabetes education program to both intervention and control participants. A total of 424 participants were recruited and enrolled (400 targeted). Of the 759 referrals received, 78.9% (n=599) successfully completed telephone screening. Of these, 78.8% (n=472) were eligible and scheduled for a local enrollment day, and 81.4% (n=384) attended and enrolled in the study. In addition, community members who walked in and expressed interest were screened, and 40 eligible and willing individuals were consented and enrolled. We exceeded recruitment goals in underserved, rural communities in Alabama. This success was due in large part to community partnerships that facilitated community involvement on several levels: engaging the community early in study proposal and design; hiring community members to fill various capacities as research team members, recruiters, and data collectors; conducting data collection within communities; and collecting additional contact information to maintain communication. Providing diabetes education to all participants, including intervention and control, helped ensure that everyone stood to benefit and likely enhanced overall participation. Copyright © 2012 Elsevier Inc. All rights reserved.
Lefler, Leanne L
Recruitment of older adults for clinical research, especially racial/ethnic minorities, is challenging at best. This article reports the author's experience and reviews current literature regarding faith-based methods to recruit older Black and White women for research. Her work and the literature review suggest 10 major recommendations for faith-based recruitment. Recommendations include: Select only faith institutions with religious leaders who actively advocate and collaborate; select key advisors or "insiders" to facilitate and customize the study; use culturally appropriate and age-sensitive recruitment and study materials; use faith institution facilities and promote access; use incentives; increase "face time"; use existing faith groups to encourage peer support; make it a social event and make it fun; provide personal benefit to participation; and customize spirituality. Involvement with faith institutions may be essential to reach groups who have been underrepresented in research. Copyright 2009, SLACK Incorporated.
Isotretinoin conundrum: a randomized, openlabel, crossover study in Mexico to evaluate the bioavailability and bioequivalence of three pharmaceutical preparations of isotretinoin in healthy participants.
Piñeyro-Garza, Everardo; Gómez-Silva, Magdalena; Gamino Peña, María Elena; Palmer, Jonathan; Berber, Arturo
The oral retinoid agent isotretinoin (13-cis-retinoic acid) is approved for the treatment of severe recalcitrant cystic acne. For registrational renewal of Oratane® in Mexico (isotretinoin; Laboratorios Dermatologicos Darier S.A. de C.V., Mexico), it was necessary to establish bioequivalence to the reference product Roaccutan® (Isotretinoin; Roche, Mannheim, Germany). Three prior studies failed to establish the bioequivalence of Oratane to Mexican-sourced Roaccutan. However, 13 studies demonstrated the bioequivalence of Oratane to Roaccutane® from multiple sources. This study compared the bioavailability of Oratane with that of Mexicansourced Roaccutan and Australian-sourced Roaccutane. Study participants received each of the three agents in a randomized, open-label, 6-sequence, 3-way crossover study with a 2-week washout period between treatments. Pharmacokinetic analysis revealed that peak plasma concentration (Cmax) and area under the plasma concentration-time curve from time 0 (dosing) to infinite time (AUC0-∞) were lower for Roaccutan than for Roaccutane and Oratane (Cmax: 1,023.35, 1,223.08, and 1,224.25 ng/mL, respectively; AUC0-∞: 13,653.65, 15,681.35 and 15,733.55 ng/mL x h, respectively). The 90% CIs (test/reference) for the ratios of the geometric means indicated that Oratane was bioequivalent to Roaccutane but not to Roaccutan. In addition, Roaccutane (R2) was not bioequivalent to Roaccutan (R1; R1/R2 90% CIs: Cmax, 76.12 - 91.04; AUC0-t, 82.19 - 91.13; AUC0-∞, 82.94 - 91.57). Oratane and Australian-sourced Roaccutane could be considered bioequivalent, but neither formulation was found to be bioequivalent to Mexican-sourced Roaccutan.
Manipulation of starch bioaccessibility in wheat endosperm to regulate starch digestion, postprandial glycemia, insulinemia, and gut hormone responses: a randomized controlled trial in healthy ileostomy participants12
Edwards, Cathrina H; Grundy, Myriam ML; Grassby, Terri; Vasilopoulou, Dafni; Frost, Gary S; Butterworth, Peter J; Berry, Sarah EE; Sanderson, Jeremy; Ellis, Peter R
Background: Cereal crops, particularly wheat, are a major dietary source of starch, and the bioaccessibility of starch has implications for postprandial glycemia. The structure and properties of plant foods have been identified as critical factors in influencing nutrient bioaccessibility; however, the physical and biochemical disassembly of cereal food during digestion has not been widely studied. Objectives: The aims of this study were to compare the effects of 2 porridge meals prepared from wheat endosperm with different degrees of starch bioaccessibility on postprandial metabolism (e.g., glycemia) and to gain insight into the structural and biochemical breakdown of the test meals during gastroileal transit. Design: A randomized crossover trial in 9 healthy ileostomy participants was designed to compare the effects of 55 g starch, provided as coarse (2-mm particles) or smooth (starch (RS) content of ileal effluent. Undigested food in the ileal output was examined microscopically to identify cell walls and encapsulated starch. Results: Blood glucose, insulin, C-peptide, and glucose-dependent insulinotropic polypeptide concentrations were significantly lower (i.e., 33%, 43%, 40%, and 50% lower 120-min incremental AUC, respectively) after consumption of the coarse porridge than after the smooth porridge (P starch digestion was slower in the coarse porridge than in the smooth porridge (33% less starch digested at 90 min, P starch from the periphery toward the particle core. The structure of the test meal had no effect on the amount or pattern of RS output. Conclusion: The structural integrity of wheat endosperm is largely retained during gastroileal digestion and has a primary role in influencing the rate of starch amylolysis and, consequently, postprandial metabolism. This trial was registered at isrctn.org as ISRCTN40517475. PMID:26333512
Manipulation of starch bioaccessibility in wheat endosperm to regulate starch digestion, postprandial glycemia, insulinemia, and gut hormone responses: a randomized controlled trial in healthy ileostomy participants.
Edwards, Cathrina H; Grundy, Myriam Ml; Grassby, Terri; Vasilopoulou, Dafni; Frost, Gary S; Butterworth, Peter J; Berry, Sarah Ee; Sanderson, Jeremy; Ellis, Peter R
Cereal crops, particularly wheat, are a major dietary source of starch, and the bioaccessibility of starch has implications for postprandial glycemia. The structure and properties of plant foods have been identified as critical factors in influencing nutrient bioaccessibility; however, the physical and biochemical disassembly of cereal food during digestion has not been widely studied. The aims of this study were to compare the effects of 2 porridge meals prepared from wheat endosperm with different degrees of starch bioaccessibility on postprandial metabolism (e.g., glycemia) and to gain insight into the structural and biochemical breakdown of the test meals during gastroileal transit. A randomized crossover trial in 9 healthy ileostomy participants was designed to compare the effects of 55 g starch, provided as coarse (2-mm particles) or smooth (starch (RS) content of ileal effluent. Undigested food in the ileal output was examined microscopically to identify cell walls and encapsulated starch. Blood glucose, insulin, C-peptide, and glucose-dependent insulinotropic polypeptide concentrations were significantly lower (i.e., 33%, 43%, 40%, and 50% lower 120-min incremental AUC, respectively) after consumption of the coarse porridge than after the smooth porridge (P starch digestion was slower in the coarse porridge than in the smooth porridge (33% less starch digested at 90 min, P starch from the periphery toward the particle core. The structure of the test meal had no effect on the amount or pattern of RS output. The structural integrity of wheat endosperm is largely retained during gastroileal digestion and has a primary role in influencing the rate of starch amylolysis and, consequently, postprandial metabolism. This trial was registered at isrctn.org as ISRCTN40517475.
The impact of escitalopram on vagally mediated cardiovascular function to stress and the moderating effects of vigorous physical activity: a randomized controlled treatment study in healthy participants.
Hanson, Camilla S; Outhred, Tim; Brunoni, Andre R; Malhi, Gin S; Kemp, Andrew H
Recent concerns over the impact of antidepressant medications, including the selective serotonin reuptake inhibitors (SSRIs), on cardiovascular function highlight the importance of research on the moderating effects of specific lifestyle factors such as physical activity. Studies in affective neuroscience have demonstrated robust acute effects of SSRIs, yet the impact of SSRIs on cardiovascular stress responses and the moderating effects of physical activity remain to be determined. This was the goal of the present study, which involved a double-blind, randomized, placebo-controlled, cross-over trial of a single-dose of escitalopram (20 mg) in 44 healthy females; outcomes were heart rate (HR) and its variability. Participants engaging in at least 30 min of vigorous physical activity at least 3 times per week (regular exercisers) showed a more resilient cardiovascular stress response than irregular vigorous exercisers, a finding associated with a moderate effect size (Cohen's d = 0.48). Escitalopram attenuated the cardiovascular stress response in irregular exercisers only (HR decreased: Cohen's d = 0.80; HR variability increased: Cohen's d = 0.33). HR during stress under escitalopram in the irregular exercisers was similar to that during stress under placebo in regular exercisers. These findings highlight that the effects of regular vigorous exercise during stress are comparable to the effects of an acute dose of escitalopram, highlighting the beneficial effects of this particular antidepressant in irregular exercisers. Given that antidepressant drugs alone do not seem to protect patients from cardiovascular disease (CVD), longitudinal studies are needed to evaluate the impact of exercise on cardiovascular stress responses in patients receiving long-term antidepressant treatment.
Basford, G. [Enmax Energy Corp., Calgary, AB (Canada)
This presentation described how the energy industry will be affected by a labour shortage as the aging workforce of baby boomers reaches retirement age. It described how Enmax Energy Corp. is dealing with demographic trends and how they affect the energy industry. The paper outlined the initiatives that the company has taken in terms of workforce planning to ensure that staffing needs are met. It described how to use demographics to identify recruitment needs within a company, and what to look for in data. It also described how to make sure that a recruitment strategy is tailored to various demographic groups. Energy companies are attracting young workers through apprenticeship programs, training and development programs, and other incentives. figs.
Chatters, Robin; Newbould, Louise; Sprange, Kirsty; Hind, Daniel; Mountain, Gail; Shortland, Katy; Powell, Lauren; Gossage-Worrall, Rebecca; Chater, Tim; Keetharuth, Anju; Lee, Ellen; Woods, Bob
Recruiting isolated older adults to clinical trials is complex, time-consuming and difficult. Previous studies have suggested querying existing databases to identify appropriate potential participants. We aim to compare recruitment techniques (general practitioner (GP) mail-outs, community engagement and clinician referrals) used in three randomised controlled trial (RCT) studies assessing the feasibility or effectiveness of two preventative interventions in isolated older adults (the Lifestyle Matters and Putting Life In Years interventions). During the three studies (the Lifestyle Matters feasibility study, the Lifestyle Matters RCT, the Putting Life In Years RCT) data were collected about how participants were recruited. The number of letters sent by GP surgeries for each study was recorded. In the Lifestyle Matters RCT, we qualitatively interviewed participants and intervention facilitators at 6 months post randomisation to seek their thoughts on the recruitment process. Referrals were planned to be the main source of recruitment in the Lifestyle Matters feasibility study, but due to a lack of engagement from district nurses, community engagement was the main source of recruitment. District nurse referrals and community engagement were also utilised in the Lifestyle Matters and Putting Life In Years RCTs; both mechanisms yielded few participants. GP mail-outs were the main source of recruitment in both the RCTs, but of those contacted, recruiting yield was low (recruited. Participants recommended that direct contact with health professionals would be the most beneficial way to recruit. Recruitment to the Lifestyle Matters RCT did not mirror recruitment to the feasibility study of the same intervention. Direct district nurse referrals were not effective at recruiting participants. The majority of participants were recruited via GP mail-outs, which may have led to isolated individuals not being recruited to the trials. Further research is required into
The aim of the project is to introduce the reader to the world of possibilities, advantages and disadvantages of current outsourcing, to highlight the factors limiting the use of outsourcing and the risks. Practical example then tries to introduce the reader to the creation and the process of the outsourcing relationship and to define the benefits and limitations resulting from the outsourcing of labour recruitment as part of personnel work.
The paper assesses non-training firm’s potential for free-riding on the training efforts of firms that train apprentices. In order to assess potential free-riding, the paper analyses whether training or non-training firms are more likely to recruit apprenticeship graduates that have been trained elsewhere. Firms without apprenticeships are less likely to hire apprenticeship graduates trained elsewhere than training firms. If these firms do hire apprenticeship graduates, they hire a smaller pr...
Adams, Swann Arp; Heiney, Sue P; Brandt, Heather M; Wirth, Michael D; Khan, Samira; Johnson, Hiluv; Davis, Lisa; Wineglass, Cassandra M; Warren-Jones, Tatiana Y; Felder, Tisha M; Drayton, Ruby F; Davis, Briana; Farr, Deeonna E; Hébert, James R
Use of community-based participatory research (CBPR) approaches is increasing with the goal of making more meaningful and impactful advances in eliminating cancer-related health disparities. While many reports have espoused its advantages, few investigations have focused on comparing CBPR-oriented recruitment and retention. Consequently, the purpose of this analysis was to report and compare two different CBPR approaches in two cancer prevention studies. We utilized frequencies and Chi-squared tests to compare and contrast subject recruitment and retention for two studies that incorporated a randomized, controlled intervention design of a dietary and physical activity intervention among African Americans (AA). One study utilized a de-centralized approach to recruitment in which primary responsibility for recruitment was assigned to the general AA community of various church partners whereas the other incorporated a centralized approach to recruitment in which a single lay community individual was hired as research personnel to lead recruitment and intervention delivery. Both studies performed equally well for both recruitment and retention (75 and 88 % recruitment rates and 71 and 66 % retention rates) far exceeding those rates traditionally cited for cancer clinical trials (~5 %). The de-centralized approach to retention appeared to result in statistically greater retention for the control participants compared to the centralized approach (77 vs. 51 %, p recruitment and retention rates of AA populations. We further note lessons learned and challenges to consider for future research opportunities.
Sin, Jacqueline; Henderson, Claire; Spain, Debbie; Gamble, Catherine; Norman, Ian
Recruitment to clinical research studies can prove complex. This is particularly true of mental health research, given factors such as confidentiality, capacity and consent, or when attempting to recruit family members as opposed to service users themselves. This study investigated the challenges experienced and strategies employed in the recruitment of siblings of people with first episode psychosis using Early Intervention in Psychosis Services (EIPS) in England. As part of a randomized controlled trial (RCT) of an e-health intervention for siblings, we conducted a process evaluation study whereby semistructured interview was undertaken with clinical and research staff involved in recruitment of siblings. Data were analysed thematically. Twelve participants from six EIPS were interviewed. Data analysis revealed seven key themes: (i) limited comprehensive family data available; (ii) data governance and consent issues; (iii) organizational factors; (iv) convoluted recruitment methods; (v) concerns about service users' opinions; (vi) fluidity in siblings' needs and expectations; and (vii) strategies to enhance recruitment. Recruitment challenges identified in this study concerned administrative, organizational, process and attitudinal issues. These are similar to other studies recruiting mental health service users as well as family members. Failure to recruit to target implies that studies are underpowered to detect potential statistically or clinically meaningful changes. Future studies should establish how best to enhance family inclusiveness in clinical practice and research. © 2016 The Authors. Health Expectations published by John Wiley & Sons Ltd.
Ballester, Belén Rubio; Nirme, Jens; Camacho, Irene; Duarte, Esther; Rodríguez, Susana; Cuxart, Ampar; Duff, Armin; Verschure, Paul F M J
Most stroke survivors continue to experience motor impairments even after hospital discharge. Virtual reality-based techniques have shown potential for rehabilitative training of these motor impairments. Here we assess the impact of at-home VR-based motor training on functional motor recovery, corticospinal excitability and cortical reorganization. The aim of this study was to identify the effects of home-based VR-based motor rehabilitation on (1) cortical reorganization, (2) corticospinal tract, and (3) functional recovery after stroke in comparison to home-based occupational therapy. We conducted a parallel-group, controlled trial to compare the effectiveness of domiciliary VR-based therapy with occupational therapy in inducing motor recovery of the upper extremities. A total of 35 participants with chronic stroke underwent 3 weeks of home-based treatment. A group of subjects was trained using a VR-based system for motor rehabilitation, while the control group followed a conventional therapy. Motor function was evaluated at baseline, after the intervention, and at 12-weeks follow-up. In a subgroup of subjects, we used Navigated Brain Stimulation (NBS) procedures to measure the effect of the interventions on corticospinal excitability and cortical reorganization. Results from the system's recordings and clinical evaluation showed significantly greater functional recovery for the experimental group when compared with the control group (1.53, SD 2.4 in Chedoke Arm and Hand Activity Inventory). However, functional improvements did not reach clinical significance. After the therapy, physiological measures obtained from a subgroup of subjects revealed an increased corticospinal excitability for distal muscles driven by the pathological hemisphere, that is, abductor pollicis brevis. We also observed a displacement of the centroid of the cortical map for each tested muscle in the damaged hemisphere, which strongly correlated with improvements in clinical scales. These
Lars Øystein Ursin
Full Text Available Rosamond Rhodes and John Harris have both recently argued that we all have a general moral duty to participate in medical research. However, neither Rhodes' nor Harris' arguments in support of this obligation stand up to scrutiny, and severe and convincing criticism has been levelled against their case. Still, to refute their arguments is not to refute the conclusion. There seems to be some truth in the view that when people are asked to take part in medical research, their choice is not completely morally neutral. In this article, we argue that the proper question to ask is when, rather than if, a certain moral duty to volunteer for medical research can be appealed to. To answer this question, we need a denser description of relevant research projects and their context rather than just describing medical research in general. Drawing on our study of participants in the Norwegian HUNT biobank, we use the normative implications of the Norwegian concept «dugnad» as an analogy to discuss the requirement of providing neutral information to potential biobank participants in order to promote their free and informed decision as to whether or not to take part. We suggest that normative recruitment is not just a question of principles and ethics. It is also a question of research design and the creation of the common good in the community where the research takes place.http://dx.doi.org/10.5324/eip.v2i2.1697
Rationale and design of the participant, investigator, observer, and data-analyst-blinded randomized AGENDA trial on associations between gene-polymorphisms, endophenotypes for depression and antidepressive intervention: the effect of escitalopram versus placebo on the combined dexamethasone
Knorr, Ulla; Vinberg, Maj; Klose, Marianne
, a 60% power is obtained to detect a clinically relevant difference in the primary outcome between the intervention and the placebo group. Secondary outcome measures are changes from baseline to four weeks in scores of: 1) cognition and 2) neuroticism. Tertiary outcomes measures are changes from...... hypothesize that potential endophenotypes for depression may be affected by selective serotonin re-uptake inhibitor antidepressants in healthy first-degree relatives of depressed patients. The primary outcome measure is the change in plasma cortisol in the dexamethasone-corticotrophin releasing hormone test...... from baseline to the end of intervention. METHODS: The AGENDA trial is designed as a participant, investigator, observer, and data-analyst-blinded randomized trial. Participants are 80 healthy first-degree relatives of patients with depression. Participants are randomized to escitalopram 10 mg per day...
Hodgson, Carol; Goligher, Ewan C; Young, Meredith E; Keating, Jennifer L; Holland, Anne E; Romero, Lorena; Bradley, Scott J; Tuxen, David
Recruitment manoeuvres involve transient elevations in airway pressure applied during mechanical ventilation to open ('recruit') collapsed lung units and increase the number of alveoli participating in tidal ventilation. Recruitment manoeuvres are often used to treat patients in intensive care who have acute respiratory distress syndrome (ARDS), but the effect of this treatment on clinical outcomes has not been well established. This systematic review is an update of a Cochrane review originally published in 2009. Our primary objective was to determine the effects of recruitment manoeuvres on mortality in adults with acute respiratory distress syndrome.Our secondary objective was to determine, in the same population, the effects of recruitment manoeuvres on oxygenation and adverse events (e.g. rate of barotrauma). For this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), Embase (OVID), the Cumulative Index to Nursing and Allied Health Literature (CINAHL, EBSCO), Latin American and Caribbean Health Sciences (LILACS) and the International Standard Randomized Controlled Trial Number (ISRCTN) registry from inception to August 2016. We included randomized controlled trials (RCTs) of adults who were mechanically ventilated that compared recruitment manoeuvres versus standard care for patients given a diagnosis of ARDS. Two review authors independently assessed trial quality and extracted data. We contacted study authors for additional information. Ten trials met the inclusion criteria for this review (n = 1658 participants). We found five trials to be at low risk of bias and five to be at moderate risk of bias. Six of the trials included recruitment manoeuvres as part of an open lung ventilation strategy that was different from control ventilation in aspects other than the recruitment manoeuvre (such as mode of ventilation, higher positive end-expiratory pressure (PEEP) titration and lower tidal volume or plateau
The objectives of this article were to provide a comprehensive overview of the recruitment experience and participant characteristics in an antihypertensive dietary educational intervention pilot trial among Chinese Canadians. The recruitment was conducted in a community centre. Two recruitment approaches, self-referral and proactive recruitment, were used. Among 618 Chinese Canadians in the blood pressure screening, 105 (17.0%) individuals were eligible to participate in this trial. Of the 105 eligible individuals, 45 (42.9%) declined enrollment and 60 (57.1%) consented to participate in the trial and were recruited. The most common reason for refusal was being unable to access to the education location (n=19, 42.2%) followed by being too busy to participate (n=18, 40.0%). All participants were Chinese immigrants and the mean number of years living in Canada was 9.2. Most participants had low English proficiency, accepted Chinese culture more than Western culture, and had strong traditional health beliefs. It is concluded that both self-referral and proactive recruitment approaches were effective. Home-based interventions using Internet and telephone should be used as alternative delivery approaches to improve recruitment rate and facilitate participation. Copyright © 2017 Elsevier Inc. All rights reserved.
Tompkins, D Andrew; Sides, Jessica A; Harrison, Joseph A; Strain, Eric C
Alcohol use disorders (AUDs) represent a large public health burden with relatively few efficacious pharmacotherapies. Randomized controlled trials (RCTs) for new AUD therapies can be hampered by ineffective recruitment, leading to increased trial costs. The current analyses examined the effectiveness of recruitment efforts during two consecutive outpatient RCTs of novel AUD pharmacotherapies conducted between 2009 and 2012. During an initial phone screen, participants identified an ad source for learning about the study. Qualified persons were then scheduled for in-person screens. The present analyses examined demographic differences amongst the eight ad sources utilized. Recruitment effectiveness was determined by dividing the number of persons meeting criteria for an in-person screen by the total number of callers from each ad source. Cost-effectiveness was determined by dividing total ad source cost by number of screens, participants randomized, and completers. 1,813 calls resulted in 1,005 completed phone screens. The most common ad source was TV (34%), followed by print (29%), word-of-mouth (11%), flyer (8%), internet (5%), radio (5%), bus ad (2%), and billboard (1%). Participants reporting bus ads (46%), billboard (44%), or print ads (34%) were significantly more likely than the other sources to meet criteria to be scheduled for in-person screens. The most cost-effective ad source was print ($2,506 per completer), while bus ad was the least cost-effective ($13,376 per completer). Recruitment in AUD RCTs can be successful using diverse advertising methods. The present analyses favored use of print ads as most cost-effective.
Holm, Anna; Ulhøi, John Parm
Up to now, there has been little research on recruitment practices from an organizational perspective, and in part it lags behind practice. This paper attempts to rectify this by studying recent changes in the recruitment practices of Danish organizations. We employ new institutional theory...... as a theoretical lens in order to understand how shared rules, norms and beliefs guide recruitment professionals in their choice of recruitment tactics and ways of performing recruitment tasks. Our findings suggest that recruitment practices have been strongly influenced by changes in the labour market, technology......, and individuals’ social cognition. Among other things, this is reflected in the use of online recruitment and employer branding. The study concludes that the recruitment field has transformed and reviewed its practices due to institutional changes in how individuals search for employment and expect to be hired....
Suggestions for recruiting teachers are as follow: talk to teens, recruit from within, involve counselors, target uncertain students, network, build relationships with tech prep, enlist military personnel, recruit extension agents, contact outplacement and employment services, and use distance-learning methods. (JOW)