***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Eighteen months after the 1980 initiation of the Canadian National Breast Screening Study ( NBSS ) ( a multicenter r and omized controlled trial that will involve 90,000 women ) , the Toronto center experience such severe problems with recruitment that the study as a whole was jeopardized . Impediments to recruitment arose in five areas . The design of the protocol was criticized by some physicians and participants , a problem that could only be met by justifying the design . A second problem was a lack of underst and ing of the concept of screening and mistaken assumptions about what participation in the NBSS entailed . Thirdly , recruitment problems occurred at a time when the media were focusing much attention on the hazards of low-level ionizing radiation . Fourthly , women were found to have a variety of personal reasons for delaying or avoiding entry into the study . Finally , factors characteristic of the Canadian milieu such as universal health coverage may have acted as a disincentive to entry . To improve physician underst and ing , NBSS personnel made presentations at medical rounds and scientific meetings ; articles were written for medical journals . To win support from the lay public , talks were given to recreation or work-based groups . Appearances on radio and television talk shows were sought out . Mass mailings to university staff and professional associations did not produce large responses , nor did advertisements on television , radio , or in newspapers . The distribution of a check insert in a government mailing gave rise to hundreds of appointments across Canada . However , for generating an ongoing adequate level of recruitment , the best measure has been the mailing of personally addressed letters to eligible women followed by a telephone call . Data on response rates , cost and women 's attitudes toward the study are reported . By early 1983 , Toronto met its recruitment target of 12,000 Identifying strategies for successful recruitment of ethnic minorities into scientific studies is critical . Without effective methods , investigators may fail to recruit the desired sample size , take longer to recruit than planned , and delay progress for research in minority health . Direct mail is an appealing recruitment method because of the potential for reaching large target population s and producing a high volume of inquiries about a study with relatively little staff effort . To determine which of three direct mail strategies yielded higher recruitment , 561 Hispanic employees were r and omly assigned to receive either : ( a ) a flyer about a worksite dietary intervention ; ( b ) the same flyer plus a personalized h and -signed letter containing heart disease risk statistics for the general American population ; or ( c ) the flyer plus a personalized h and -signed letter containing statistics for Hispanics . Two orthogonal chi-square comparisons were examined . The personalized letters plus flyer yielded a significantly higher response rate ( 7.8 % ) than the flyer alone ( 2.1 % ) , X2(1 , N=561)=7.5 , p=.006 . However , the personalized letter with Hispanic heart disease risk statistics did not yield a statistically significant higher response rate ( 9.1 % ) than the letter with the general population risk statistics ( 6.5 % ) , X2(1 , N=370)=0.9 , p>.34 . These findings suggest that personalized approaches can increase the effectiveness of direct mail efforts for recruiting ethnic minorities into interventions and may be particularly helpful for large-scale interventions BACKGROUND Latinas have low rates of participation in breast cancer prevention trials . We evaluated the feasibility and effectiveness of a r and omized trial of brief counseling and print material s compared to print material s alone to increase intent to participate in a breast cancer prevention trial . METHODS We enrolled 450 women Spanish-speaking women from three urban community primary care clinics . The outcome was intent , defined as might , probably , or definitely would enroll in the trial . We also examined results using a more stringent definition restricted to probably and definitely intend to participate . RESULTS The trial was feasible within these busy clinics , and 96 % of women agreed to participate . The level of breast cancer knowledge was fairly high ( 66 % correct answers ) , but underst and ing about clinical trials was lower ( 40.5 % correct answers ) . Using the less stringent criteria for intent , 72 % of women stated that they intended to enroll in the STAR trial if eligible , but rates of intent decreased to 52 % with framing that included medication side effects and 45 % if uterine cancer was mentioned ( P < 0.01 for trend ) . Using the more stringent definition , slightly fewer than half of the women indicated an interest in participating , with the same trend towards decreasing intent with increasing presentation of side effects . The intervention was only effective using the less stringent definition and if no side effects were mentioned ( 77 % intent vs. 67 % in the intervention and control groups , respectively , P = 0.03 ) . Intention was independently associated with greater worry about breast cancer and younger age , but not acculturation or knowledge . CONCLUSIONS Latina women are interested in participating in clinical trials to prevent breast cancer , although interest declines with increasing discussion of side effects . Unfortunately , brief education only increased rates of intention using the least stringent definition and when no side effects were presented in framing the question . Future work should focus on qualitative research to underst and the theoretical foundations of preventive health behaviors in this population PURPOSE Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population . This study hypothesized that use of an easy-to-read consent statement , when compared with a st and ard consent statement , will result in higher patient comprehension of the clinical treatment protocol , lower patient anxiety , higher patient satisfaction , and higher patient accrual . METHODS A r and omized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncology groups . Institutions were r and omly assigned to administer either an easy-to-read consent statement or the st and ard consent statement to patients being recruited to participate in selected cancer treatment trials .  Telephone interviews were conducted with a total of 207 patients to assess study outcomes . RESULTS Patients in the intervention arm demonstrated significantly lower consent anxiety and higher satisfaction compared with patients in the control arm . Patient comprehension and state anxiety were not affected by the intervention . Accrual rates into the parent studies also did not differ significantly between the two study groups . CONCLUSION Clinical trial informed consent statements can be modified to be easier to read without omitting critical information . Patient anxiety and satisfaction can be affected by the consent document . The generalizability of these study results is limited by the characteristics of the patient sample . Ninety percent of the sample were white women , and the mean Rapid Estimate of Adult Literacy in Medicine score was approximately 64 , indicating a literacy level at or above the ninth grade Recruitment to cancer clinical trials needs to be improved , as does patient knowledge and underst and ing about clinical trials , in order for patients to make an informed choice about whether or not to take part . Audiovisual patient information ( AVPI ) has been shown to improve knowledge and underst and ing in various areas of practice , but there is limited information about its effect in the cancer clinical trial setting , particularly in relation to consent rates . In this study , 173 patients were r and omised to receive either the AVPI , in addition to the st and ard trial-specific written information , or the written information alone . There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates : 72.1 % in the AVPI group and 75.9 % in the st and ard information group . The estimated odds ratio for refusal ( intervention/no intervention ) was 1.19 ( 95 % CI 0.55–2.58 , P=0.661 ) . Knowledge scores increased more in the AVPI group compared to the st and ard group ( P=0.0072 ) . The change in anxiety score between the arms was also statistically significant ( P=0.011 ) with anxiety improving in the intervention arm more than in the no intervention arm . Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety , but further work is necessary in relation to its effect on clinical trial recruitment rates A common question in clinical consultations is : “ For this person , what are the likely effects of one treatment compared with another ? ” The central tenet of evidence based medicine is that this task is achieved by using the best evidence combined with consideration of that person 's individual needs.1 A further question then arises : “ What is the best evidence ? ” Two recent studies in the New Engl and Journal of Medicine have caused uproar in the research community by finding no difference in estimates of treatment effects between r and omised controlled trials and non-r and omised trials . The r and omised controlled trial and , especially , systematic review s of several of these trials are traditionally the gold st and ards for judging the benefits of treatments , mainly because it is conceptually easier to attribute any observed effect to the treatments being compared . The role of non-r and omised ( observational ) studies in evaluating treatments is contentious : deliberate choice of the treatment for each person implies that observed outcomes may be caused by differences among people being given the two treatments , rather than the treatments alone . Unrecognised confounding factors can always interfere with attempts to correct for identified differences between groups . These considerations have supported a hierarchy of evidence , with r and omised controlled trials and derivatives at the top , controlled Background and Purpose — Methods to increase recruitment into acute stroke trials are needed . The purpose s of this study were to evaluate the safety and acceptability of initiating acute stroke trials during early helicopter evacuation and to test an intervention to facilitate informed consent . Methods — A r and omized , controlled trial was done with patients with acute stroke who were transferred by helicopter to the University of Iowa Hospitals and Clinics from February 2007 to January 2008 . The intervention to be evaluated was the use of fax and a telephone call to the patient/surrogate ahead of helicopter arrival at the outside emergency department . The aim was to improve the rate of subsequent consent ( primary outcome ) for a pilot trial of a potentially beneficial , low-risk medical intervention ( ranitidine ) to prevent aspiration pneumonitis . Consenting eligible patients received the infusion during the flight to University of Iowa Hospitals and Clinics . Results — One hundred patients were enrolled .  Consent rate was 54 % in the intervention group and 50 % in the control group ( P=0.69 ) . However , the consent rate was higher ( 69 % ) when prearrival communications between the coinvestigator and potential subjects were successful ( P=0.04 ) . This approach result ed in an average gain of 59 minutes as compared with initiating recruitment on arrival to University of Iowa Hospitals and Clinics . Conclusions — Enrollment into stroke intervention trials is feasible during helicopter transportation from a community hospital emergency department to a tertiary stroke center . This underused re source may improve trial efficiency by enabling and expediting participation of remote population s currently excluded from research . Consent rates might be further improved by communication strategies that are more successful in reaching patients at outside emergency departments BACKGROUND To evaluate the impact of an educational booklet on women 's  knowledge of and willingness to participate in a r and omized clinical trial of treatment for breast cancer . MATERIAL S AND METHODS Women undergoing surgery for newly diagnosed early stage breast cancer were r and omized to receive , or not , an information booklet explaining the need for and manner in which r and omized trials are conducted . RESULTS Eighty-three women with newly diagnosed early stage breast cancer completed a question naire assessing attitudes to r and om clinical trials ( RCTs ) and were r and omized to receive usual information treatment options provided from their oncologist , or the educational booklet in addition to usual information from their oncologist ( 42 usual information , 41 booklet ) . Fewer women who received the clinical trials booklet ( 40 % versus 47 % ) would consider participating in the hypothetical clinical trial ( P = 0.6 ) . Mean knowledge scores increased for both groups ; moreover , women who did not receive the booklet showed similar improvements to women who received the booklet [ mean difference 0.09 , 95 % confidence interval ( CI ) -0.66 to 0.83 ] . In a multivariate analysis women who would consider participating in the clinical trial were more anxious [ odds ratio ( OR ) 5.9 , P = 0.02 ] had involved lymph nodes ( OR 5.8 , P = 0.02 ) and were less influenced by negative aspects of clinical trials ( OR 7.7 , P = 0.0001 ) . After adjustment for these variables women who received the educational booklet were significantly less likely to consider trial participation ( OR 0.22 , P = 0.05 ) . CONCLUSIONS Educating women about clinical trials in this manner appears ineffective in improving recruitment to RCTs . Women appear to be more influenced by their perception of risk than underst and ing . This finding has ethical implication s for communication of information about RCTs Recruitment into public health intervention trials can be costly and time-consuming . We examined two components of recruitment for an exercise trial : ( a ) a r and omized pilot study of mailing strategies ; and ( b ) the results from the entire recruitment process . In the pilot study , 4,999 women were r and omized into one of four groups using a factorial design . The first factor was the inclusion or exclusion of a personal invitation letter , and the second was the use of first-class stamps versus bulk mail . We received 580 ( 11.6 % ) responses . Responses from interested women were nonsignificantly higher ( odds ratio , 1.19 ; P = 0.10 ) for first-class versus bulk-rate postage . However , the cost to r and omize one participant using first-class mail was $ 56.14 ( in 1998 dollars ) more than for bulk mail . We found no difference in response when including the invitation letter ( odds ratio , 1.00 ; P > 0.50 ) . The general recruitment process identified potentially eligible women primarily through mass mailings but also through media and other sources . We mailed recruitment material s , via bulk mail and including an invitation letter , to 103,577 women in the Seattle area over 2 years .  Response rates were different ( P < 0. 
    Output:
    
Patrina Caldwell and colleagues performed a systematic review of r and omized studies that compared methods of recruiting individual study participants into trials , and found that strategies that focus on increasing potential participants ' awareness of the specific health problem , and that engaged them , appeared to increase recruitment