Basic clinical skills training in the Japanese medical education system has traditionally incorporated on-the-job training with patients. Recently, the complementary use of simulation techniques as part of this training has gained popularity. It is not known, however, whether the participants view this new type of education program favorably; nor is the impact of this program known. In this study we developed a new simulation-based training program in phlebotomy for new medical residents and assessed their satisfaction with the programThe education program comprised two main components: simulator exercise sessions and the actual drawing of blood from other trainees. At the end of the session, we surveyed participant sentiment regarding the program.There were 43 participants in total. In general, they were highly satisfied with the education program, with all survey questions receiving scores of 3 or more on a scale of 1–5 (mean range: 4.3 – 4.8), with 5 indicating the highest level of satisfaction. Additionally, their participation as a 'patient' for their co-trainees was undertaken willingly and was deemed to be a valuable experience.We developed and tested an education program using a simulator for blood collection. We demonstrated a high satisfaction level among the participants for this unique educational program and expect that it will improve medical training, patient safety, and quality of care. The development and dissemination of similar educational programs involving simulation for other basic clinical skills will be undertaken in the future. Medical education covers a broad spectrum of concepts and skills, involving not only academic and scientific training but also the acquisition of clinical skills related directly to patient care. Traditionally, medical schools in Japan have provided a passive educational experience, focusing more on academics than on hands-on clinical training. For example, although clinical clerkships were introduced to medical schools, allowing students to rotate between each clinical department every few weeks, students were relegated to a bystander role and were not permitted to directly participate in the provision of patient care. Whereas this traditional education system has undoubtedly contributed to the education of medical students, it is not well-suited to assisting today's students and young doctors in the acquisition of necessary clinical skills. In fact, under the traditional system, even the most basic skills involved in patient care could only be learned after medical license certification.In recent years, medical education in Japan has changed greatly. As part of this change, a national core curriculum has been proposed that advocates a shift in clinical practicum training to participatory clerkships. Moreover, the National Common Achievement Test (CAT), which includes Computer Based Testing (CBT) and Objective Structured Clinical Examination (OSCE), was introduced nationally in 2005 . The CBTPrevious reports from European medical schools, however, have cast doubt as to the effectiveness of the clerkship experience alone in providing adequate basic clinical skills training . It has Simulation programs have become increasingly popular as they have the potential to reduce patient risk in clinical training and improve the quality of patient care. One example of a simulation program is the Advanced Cardiac Life Support training course , and manIn April 2006, we conducted a simulation-based phlebotomy education program for first-year residents, in which they received training for drawing blood from the forearm peripheral vein. In addition, the participants had the opportunity to practice on each other at the end of the program. This course was directed by three investigators , who also acted as trainers for the entire program. The study comprised 43 first-year residents, who were divided into five groups of eight or nine participants each. Each group received identical training sessions, and, prior to the start, the participants were provided with extensive details of the program by the researchers. Each participant submitted a written informed consent both for the education program and for the study. The program and study were approved by the ethics committee of Kumamoto University.Each program session lasted for 3 hours and was conducted as follows.Video orientation session (20 min). Each group of participants was shown a video that provided examples of the basic technique used for drawing blood from peripheral veins. Videos were followed by a brief discussion.1. Role playing simulation exercise (40 min). Each trainee in the patient role was fitted with a phlebotomy simulator  that was wrapped around their forearm and simulated blood withdrawal was performed . Trainees were paired up and assigned a role playing exercise in which one played the role of the physician and the other the patient in a scenario involving an accident. The trainee in the patient role was provided with information about the "accident" for which they were presenting to the "physician", whereas the "physician" was provided with only minimal information, such as the setting of the accident and the age of the presenting "patient". The "physician" was assessed not only on his or her ability to take blood but also on his or her ability to communicate with the "patient" and obtain pertinent information necessary to make a diagnosis and decide on treatment. All participants played the role of physician and patient at least once. Examples of scenarios that the "physicians" were forced to confront included loss of patient consciousness during blood withdrawal, a patient with hematoma, and a patient with median nerve injury. The cases in each scenario were designed based on the authors' personal experience, expected frequency of such a case, and the degree of injury to the "patient". All role-playing sessions were video recorded [3. recorded .Video Review (30 min). All participants watched the video recordings of their role-playing scenarios together and discussed their performances with each other and with the trainers. The trainers tried to elicit the participants' assumptions about the situation and their reasons for acting as they did while in the role of physician [4. hysician . AdditioPeer assessment (15 min). The quality of each trainee's blood drawing technique was assessed by their peers based on the same structured assessment sheet used in the previous simulator exercise session . In the final portion of the educational program, the participants drew blood from each other at most twice, under a trainer's supervision. Whereas training with the simulator was a mandatory part of the medical training program, practicing on other trainees or acting as a subject for actual blood drawing was not, since they would be exposed to some degree of risk of injury. Despite this, all participants completed the entire program.6. At the end of the session, we anonymously surveyed all participants about their views of the program. Answers to each question were given on a Likert scale of 1 to 5, where a 1 meant fully disagree and a 5 meant fully agree. These results were tallied and displayed using boxplots .The survey questions given to each participant in this study along with the corresponding results displayed as boxplots are presented in Figure In this study, we developed and assessed the satisfaction with a new education program on phlebotomy for novice medical residents. This program allowed the residents to experience the blood drawing technique both as a medical professional and as a patient. In general, the participants were highly satisfied with the program.Our findings are consistent with and extend previous studies from other countries and institutions ,5,10,11.Educational programs incorporating role playing and simulation are currently recognized as valuable training tools for medical professionals that enable the attainment of practical skills without posing a risk to patients -15. Our Although it is clear that simulation-based educational programs have great utility in providing valuable training in basic clinical skills, it is obviously not possible to use such programs for the teaching of more invasive procedures, as it would not be possible to guarantee acceptable safety for the participants in such programs. That does not diminish the value of such programs. Rather, the high level of trainee satisfaction and the potential to learn important clinical skills highlights that this type of program should be an integral part of a larger educational system.Our study had some limitations. First, the study was a cross-sectional survey of a small number of participants at a single institution, limiting the generalization of our results to other institutions and countries. Our results and the responses from participants may have been influenced by their cultural background as well as the Japanese style of education system and medical school programs. Second, the survey questions themselves or the fact that participants were surveyed immediately following the conclusion of the education program may have influenced participants' responses to overestimate the satisfaction level, for example by taking advantage of their feeling of accomplishment. Despite these limitations, however, the present findings indicate that our program is of considerable benefit for inexperienced trainees.In conclusion, we have prepared and tested a new training program for phlebotomy, a technique that is one of the most basic and frequently used by medical professionals. The participants played the roles of both medical professional and patient, allowing them to gain the practical skills necessary to properly perform the technique as well as an enhanced empathy for the patient experience. This represents a valuable and unique educational experience for them. This study further shows that this type of program can go a long way towards meeting patient expectations that physicians will be highly skilled in all aspects of the delivery of medical care. Our results suggest that the unique experience of simulation education may contribute to quality improvement of patient care and safety. The design and employment of effective simulation education programs for various other basic clinical skills will further improve training and should be an integral part of the medical school curriculum.The author(s) declare that they have no competing interests.JT and KM conceived of the study. JT, KM, and TA were involved in planning and conducting the education program in the study. JT and KM drafted the manuscript. All authors read and approved the final version of the manuscript.The pre-publication history for this paper can be accessed here:


The transition to adolescence is a time of increased vulnerability for risk taking and poor health, social and academic outcomes. Parents have an important role in protecting their children from these potential harms. While the effectiveness of parenting programs in reducing problem behavior has been demonstrated, it is not known if parenting programs that target families prior to the onset of significant behavioral difficulties in early adolescence (9-14 years) improve the wellbeing of adolescents and their parents. This paper describes the rationale and methodology of a randomised controlled trial testing the efficacy of a parenting program for the promotion of factors known to be associated with positive adolescent outcomes, such as positive parenting practices, parent-adolescent relationships and adolescent behavior.One hundred and eighty parents were randomly allocated to an intervention or wait list control group. Parents in the intervention group participated in the ABCD Parenting Young Adolescents Program, a 6-session behavioral family intervention program which also incorporates acceptance-based strategies. Participants in the Wait List control group did not receive the intervention during a six month waiting period. The study was designed to comply with recommendations of the CONSORT statement. The primary outcome measures were reduction in parent-adolescent conflict and improvements in parent-adolescent relationships. Secondary outcomes included improvements in parent psychosocial wellbeing, parenting self-efficacy and perceived effectiveness, parent-adolescent communication and adolescent behavior.Despite the effectiveness of parenting programs in reducing child behavioral difficulties, very few parenting programs for preventing problems in adolescents have been described in the peer reviewed literature. This study will provide data which can be used to examine the efficacy of a universal parenting interventions for the promotion of protective factors associated with adolescent wellbeing and will add to the literature regarding the relationships between parent, parenting and adolescent factors.Australian New Zealand Clinical Trials Registry ACTRN12609000194268. Many critical life changes occur during the developmental period of transition from childhood to adolescence. The commencement of secondary school coincides with the numerous shifts in physical, social and cognitive functioning associated with development and puberty ,2. The mAlong with community, school and individual factors, research has demonstrated the major role that parents play in building resilience in children and promoting the successful transition from childhood to adulthood -12. BroaConversely, experiencing feelings of love and respect, and having a warm relationship with at least one parent, are associated with positive adolescent outcomes such as better engagement in school, better academic outcomes for children and a reduction in the influence of the drinking patterns of peers -24. LikeCombined, this research indicates that adolescence is a key time for the development of high risk behaviors and that parenting during early adolescence has an important impact on adolescent outcomes. Therefore, early adolescence is a time during which the introduction of effective prevention strategies is of paramount importance ,26. A spParenting programs, particularly those utilizing a social learning approach and incorporating behavior management training, can be effective in producing positive outcomes for both parents and their children -33. The This increased recognition of the importance of the transition to adolescence, the potential protective role of parents, and the opportunity to prevent negative outcomes for adolescents  has led Despite the increased recognition of the relevance of programs about raising adolescents, research in this area has tended to report lower levels of engagement and higher levels of drop out than programs targeting parents of young children -51 with Further to difficulties with engagement and retention, evaluations of parenting programs suggest that traditional behavioral models of parenting interventions are insufficient to meet the needs of all families -56. As sFurther research is required to determine whether preventative parenting interventions delivered prior to the onset of difficulties are an effective method for changing family and other contextual factors sufficiently to improve the wellbeing of adolescents and their parents. It is also important to further investigate whether adjunctive theoretical approaches such as mindfulness or acceptance can improve engagement and retention and strengthen outcomes of interventions targeting parents of young adolescents. Therefore, the primary aim of the present research is to examine the efficacy of a parenting program that combines a behavioral family intervention approach with acceptance-based strategies in promoting improved parental wellbeing, parenting practices, parent-adolescent relationships and adolescent behaviour. A secondary aim of this research program is to add to the literature regarding the relationships between parent, parenting and adolescents factors.This study was a randomised controlled trial in which 180 parents of adolescents were randomly allocated to one of two conditions; intervention or a wait-list control group. Parents in the intervention group participated in the ABCD Parenting Young Adolescents Program, a 6-session behavioral family intervention program which also incorporates acceptance-based strategies ,59,60. TThe ABCD Parenting Program was delivered in community settings throughout the North and West Metropolitan Region of Melbourne, Australia. To maximize accessibility for parents, both daytime and evening sessions were offered and a range of venues, including primary and secondary schools, Community Health Centres, and Neighbourhood Houses.The project received ethics approval from four separate ethical standard bodies; the Victorian Government, Department of Human Services Human Research Ethics Committee, RMIT University, the Victorian Department of Education and Training and the Catholic Education Office, Archdiocese of Melbourne Human Research Ethics Committees. The project has been registered as a clinical trial with the Australian New Zealand Clinical Trials Registry (ANZCTR) which sets the standards for the uniform reporting of the minimum registration data set as determined by the World Health Organization and the International Committee of Medical Journal Editors. ANZCTR Registration Number is ACTRN12609000194268.Participants were included in the study if they met the following criteria; (a) parents of an adolescent aged 9-14 years, (b) custodial parents or non-custodial parents with regular access to their children, (c) English speaking, and (d) living in the north and west metropolitan region of Melbourne. Families were excluded from the study if (a) parents or adolescents had learning or developmental difficulties, (b) parents or adolescents had a mental illness, (c) adolescents had a medical condition or physical disability, or (d) adolescents were receiving other specialist services  or participating in other research projects. These inclusion and exclusion criteria were assessed via parent self-report.Information about the ABCD Parenting Program was circulated throughout the community via advertisement in local newspapers and Regional Parenting Centres' newsletters. Letters and promotional materials were also provided to schools, neighbourhood houses, General Practitioners, medical and community health centres and professionals registered with the Parenting Research Centre's professional mailing list. All recruitment information requested that parents contact the Parenting Research Centre for more information about the program. Professional referrals were only accepted after parents contacted the centre themselves.Enquiries from parents living or working in the appropriate catchment area, with children aged 9 to 14 years of age were forwarded to the project team by centre administrative staff. A minimum of three attempts were made to contact these parents via telephone or email. Parents who could be contacted were first assessed against the eligibility criteria. Those who were not eligible were provided with other referral options. Eligible parents were given a detailed outline of the research including a review of the intervention program and assessment procedures and details of the randomisation, evaluation and wait-list processes. Those electing to proceed were asked to complete a telephone conducted intake survey. This survey was used to collect data about project inclusion and exclusion criteria, parenting experiences, and general demographic information.Research assistants were trained to conduct these intake calls using a standardised script. The principal investigator monitored intake calls until research assistants demonstrated a sufficient level of competency. Random checks of intake calls were conducted throughout the project to ensure compliance with procedures. Following the intake call, eligible parents who indicated an interest in participating in the program were mailed a plain language statement, consent form and family demographic survey. Parents were asked to return the consent form and family demographic survey to register for the program.Families who did not return this information were contacted to complete a telephone conducted survey regarding their reasons for non-registration. The research assistant conducting the survey classified responses under the following categories; other family/life issues, problem resolved, project wasn't explained clearly over the phone, written information sent out was unclear or overwhelming, not comfortable completing questionnaires, didn't want to wait, program wasn't appropriate to my needs, can't remember, or other. Multiple responses were possible and all responses identified by parents were recorded. Three attempts were made to complete the telephone conducted survey with each family. A self-report version of the survey, with an invitation to return the survey by mail, was provided to those families who could not be contacted via phone.http://www.randomisation.com). This program randomises each participant to a single treatment by using the method of randomly permuted blocks. A research assistant not involved in the delivery of the program, placed participants on the randomisation list in the next available slot. Parents were then contacted by telephone to inform them of this allocation. Those allocated to the intervention condition were booked into the next scheduled group on a day and time that suited the parent. Those in the wait-list condition were advised that they would receive a phone call one month prior to their commencement date to book them into a group that was being held on a day and time that suited them.Upon receipt of the consent form and family demographic survey parents were randomly allocated to the intervention or wait-list control condition using a web based computerised randomisation plan generator  is a 5-item scale designed to assess importance, expectations and monitoring strategies reported by parents. The scale has adequate internal consistency (α = .60).The Consumer Satisfaction Scale  is a measure of consumer satisfaction with parenting programs. This 20-item questionnaire assesses the quality of the service provided, how well the program met the parent's needs and changed behaviour, and whether the parent would recommend the program to others. Parents are also prompted to make general comments or suggestions about the program.The Family Demographics survey was administered at registration, and the Consumer Satisfaction Scale was completed at post intervention. All other measures were completed by participants in both conditions at pre, post and 6-month follow-up. Those in the intervention condition also completed measures at 18-month follow-up.Pre-intervention assessments were posted to participants in the intervention condition two weeks prior to the commencement of their scheduled group. Parents were asked to return their questionnaires to the first group session. Post-intervention assessments were distributed in the final group session and parents were asked to return the questionnaire in the reply-paid envelop provided. The first follow up assessment was conducted 6 months after program completion. Questionnaires were mailed to parents with a request that they be returned in the reply-paid envelope provided.Participants in the wait-list condition received pre-intervention, post-intervention and follow-up questionnaires at the same time as parents in the intervention condition. Questionnaires were mailed to parents with a request that they be returned in the reply-paid envelope provided. Generally, parents allocated to the wait-list condition completed their follow-up questionnaires just prior to participating in the ABCD Parenting Program.Parents in the intervention condition also completed a long-term follow-up assessment 18 months after program completion. It was not possible to conduct long-term follow-up assessments with parents in the wait-list condition as it was not considered ethical to delay intervention for longer than 6 months.A number of steps were taken to promote maximum return rates. If questionnaires were not returned within 14 days of distribution, parents were contacted by phone. During the call, the research assistant answered any questions about the questionnaires and arranged for another to be sent if required. A second reminder call was made if questionnaires were not returned within 21 days of distribution. If questionnaires were not received within 28 days of distribution parents were sent a reminder letter, and a second copy of the questionnaire mailed to them.The ABCD Parenting Young Adolescents Program : ABCD is a group program for parents of children aged from 9-14 years. The program is a brief psycho-educational intervention based on social learning principles and incorporating acceptance-based strategies. An emphasis is placed on active skills building and problem solving, and strategies that have been shown by research to reduce distress in interpersonal relationships. The aim of the program is to provide parents with information and skills for developing and maintaining trusting, positive and accepting relationships with their young adolescents which, in turn, encourages them to test their independence within safe boundaries.The program is delivered over six consecutive weeks. During each 2-hour session parents have the opportunity to discuss, practice and receive feedback on a range of strategies and ideas. The program content is designed to enhance parental understanding and skills for assisting their children to make the transition to adolescence. Content is organised under four themes: 1) developing understanding and empathy for adolescents; 2) building strong relationships; 3) building responsibility and autonomy; and 4) parental self-care. An overview of program objectives and content is provided in Table Five group facilitators were trained by the first author, one of the program developers, thus a total of 6 facilitator's delivered programs as part of the project. The level of training was matched to the needs of the facilitator so that less experienced trainers received more comprehensive training in delivering group interventions, conducting parenting training, responding to group processes issues and content specific to the ABCD Parenting Program. Facilitators with more experience in delivering group based parenting interventions received training in the ABCD Parenting Program theory and content only. Prior to delivering groups independently, all facilitators co-facilitated groups with the first author until they demonstrated competence in delivery of the program. All facilitators received weekly supervision from the first author throughout the project. Audiovisual footage of group sessions was used throughout these supervision sessions to allow for the provision of feedback on both group process and program content.The ABCD Parenting Program was delivered as prescribed in the ABCD Parenting Young Adolescent Facilitators Manual . The manTreatment fidelity and integrity was maintained across facilitators via the use of a manualised program . FacilitAs there were no meta-analyses exploring outcomes of adolescent parenting programs available at the time of the study, results of a meta-analysis exploring the effectiveness of behavioural parenting training in modifying antisocial behaviour in children was used for power analyses,76. ThisMancovas. Both completer and intention-to-treat analyses will be conducted. The between subjects factor will be condition  and the within subjects factor will be time . The maintenance of intervention effects will also be assessed by comparing pre, post and follow-up and long-term follow-up using repeated measures Manovas. Potential confounds  and moderators  will be explored.Data will be analysed using SPSS. Analysis will be preceded by data cleaning and assumption testing. A series of analyses are planned. The primary analyses will assess the efficacy of the ABCD Parenting Program in promoting improved parental wellbeing, parenting practices, parent-adolescent relationships and adolescent behaviour. Intervention efficacy will be assessed by comparing the outcomes of the wait-list control and intervention conditions post intervention and follow-up measures using a series of 2 × 2 mixed factorial Further analyses will include exploration of the predictors of intervention outcome, and a thorough analysis of treatment adherence, compliance with intervention and other process variables. Detailed descriptive analysis of pre-intervention adolescent, parent and family characteristics will also be conducted to thoroughly explore the characteristics of families attending an adolescent focused, universal parenting program. Secondary analysis will explore the relationships between parent, parenting and adolescents factors. Based on existing literature it is predicted that positive parenting practices and parental coping and wellbeing will be associated with positive adolescent outcomes. Structural equation modeling will be used to explore the direction and strength of these complex relationships.Participant recruitment commenced in January 2005 and was completed in February 2007, at which time 180 families had enrolled to participate, ensuring an adequate number of participants for statistical comparison. Recruitment drives were conducted at the commencement of each school term. The first ABCD Parenting Program group commenced in May 2005 and the final intervention group commenced in February 2007. Twenty-one ABCD Parenting Program groups were conducted throughout this period.A total of 409 parents were contacted to complete an intake call. Twenty-one families (5%) were excluded from the study as they did not meet the eligibility criteria for one or more reasons. Of these, eight adolescents were receiving other specialist services, eight adolescents had a medical condition or physical disability, seven adolescents and four parents had a mental illness, four adolescents had learning or developmental difficulties, one was a non-custodial parent without regular access to their children, and one was non-English speaking. Thirteen (3%) parents chose not to continue with the intake call after receiving verbal information about the ABCD Parenting Program and the associated research.Three hundred and seventy five eligible (92%) parents completed intake and were mailed a plain language statement, consent form and family demographic survey. The majority of intake calls were completed with the child's mother (79.9%), 42.1% of target children were female, and the age of target children ranged from 9 to 14 years . One hundred and eighty parents returned their consent form and family demographic survey to register for the program.One hundred and ninety-five (52%) parents who completed intake did not register for the program. Reasons for non-registration included; other family/life issues (36.1%), problem resolved (18.1%), verbal project explanation unclear (10.8%), written project information unclear (19.5%), not comfortable completing questionnaires (14.5%), didn't want to wait (13.3%), program not appropriate for needs (13.4%), can't remember (6.0%), and other (75.0%). Many families provided multiple reasons for non-registration.t(353.9) = -1.23, p > .05) or sex (χ2(1) = .64, p > .05). Parents that registered for the program had a higher Socioeconomic Indexes for Areas(SEIFA) Index of Relative Socio-economic Advantage and Disadvantage based on residential postcode(t(342.9) = 2.39, p = .017) than those who did not register for the program. This indicates that families of lower socioeconomic status were less likely to register for the program.Parents that did not register for the program did not differ from those that did register in terms of their adolescent's age  or wait-list control (n = 90) conditions. Of those allocated to the intervention condition 82 (91%) were successfully enrolled into a group. It was not possible to enrol 8 (9%) registered parents in the intervention condition into groups. Eight (10%) of the 82 enrolled in a group did not attend. Of the 90 parents allocated to the intervention condition 76 (84%) returned a completed pre-questionnaire. This included all 74 parents who attended a group and two parents who were enrolled in a group but did not attend. Sixty-eight (76%) of the 90 parents allocated to the wait-list condition returned a completed pre-questionnaire. This information is presented in Figure M = 11.82, SD = 1.40), 52.2% of which were male. Where Australian 2006 population demographic data [The sample comprised 160 mothers, 19 fathers and 1 step-father of young adolescents aged from 9.0 to14.6 years . These results illustrate the importance of incorporating strategies to engage families during the early stages of recruitment. Additionally, it is important to consider methods for reducing the demands of research processes on participants, .Analysis of the characteristics of participants allocated to the intervention or wait-list conditions showed a number of features of the sample worth noting, including some important differences between study participants and Australian population norms. The study sample comprised a majority of mothers with only 11% of primary participants being fathers. A key difference between the current sample and Australian population norms related to family circumstances. This sample had a higher representation of sole and step families and a lower number of original, two parent families than recorded in the 2006 Australian Census . These rThe participants in this study also reported higher levels of post-graduate qualifications and lower levels of TAFE and high school qualifications than those reported in the 2006 Australian Census. However, these results are consistent with Spoth  who repoReports of help seeking are also noteworthy. Almost half of the participants in the current study had sought assistance from professionals in the past two years, with a proportion having also sought assistance for problems with their child in the past. More than half of the participants reported that they had not previously sought support. These results indicate that whilst a significant proportion of participants were not currently reporting difficulty, a large subset of the participants had in the past experienced some difficulty with their parenting or children. This suggests that the sample is not purely a preventative one but may include a subset of families that require treatment services. Such a finding is particularly noteworthy given the universal recruitment methods adopted for the study. Preventative interventions have been classified as falling into three potential categories, universal, selective or indicated (. Mrazek This study has been designed to address many of the limitations of previous research and to comply with the recommendations of the CONSORT statement ,62. The While the design of the current study addresses many of the limitations of previous research, several methodological issues are acknowledged. As the research was conducted within a clinical service it was necessary to offer participants allocated to the wait-list control condition intervention thus comparison between groups is not possible during the longer term follow-up period. Additionally, as there are few measures designed for assessment of impact of adolescent prevention programs, the measures used in the current study were originally designed for assessment of the impact of treatment programs. Consequently, these measures may not be sensitive enough to detect the impact of a prevention program. Further, as a result of the reliance on self-report measures this study includes only subjective reports of outcomes. The inclusion criteria used in the present study were necessary to ensure internal validity, however they do impact on the external validity of the study and hence the generalisation of results. For example non-English speaking families were not included in this study and thus result may not apply to this important group. Similarly, the self-selected sample used in this study was relatively well educated and of high socioeconomic status, consequently, results may not apply to families with lower levels of income and/or education.Despite these limitations the current study will provide much needed information about the efficacy of parenting interventions for families with young adolescent children.In conclusion, the present study will provide much needed information about the role of parents in the promotion of factors that prevent serious psychological and behavioral difficulties for young people. Outcome analysis will assess the impact of a behavioral family intervention program incorporating acceptance-based strategies on parenting practices, parent-adolescent relationships, and adolescent outcomes. It will also explore the relationships between parent, parenting and adolescents factors.The ABCD Parenting Program was co-authored by KB. The Parenting Research Centre has the rights to this program and all authors were employed by the Parenting Research Centre during design and implementation of the trial and development of the manuscript.KB co-authored the ABCD parenting program, trained and supervised all facilitators, facilitated groups, designed and managed the efficacy trial, and contributed to manuscript development. LB facilitated groups, designed and assisted with the management of the efficacy trial, was responsible for data cleaning and analysis, and contributed to manuscript development. SR assisted with participant and data management. All authors have read and approved the final manuscript.


Phone-based tobacco cessation programs have been proven effective and widely adopted. Web-based solutions exist; however, the evidence base is not yet well established. Many cessation treatments are commercially available, but few integrate the phone and Web for delivery and no published studies exist for integrated programs. This paper describes a comprehensive integrated phone/Web tobacco cessation program and the characteristics, experience, and outcomes of smokers enrolled in this program from a real-world evaluation. We tracked program utilization , quit status, satisfaction, and demographics of 11,143 participants who enrolled in the Free & Clear Quit For Life Program between May 2006 and October 2007. All participants received up to five proactive phone counseling sessions with Quit Coaches, unlimited access to an interactive website, up to 20 tailored emails, printed Quit Guides, and cessation medication information. The program was designed to encourage use of all program components rather than asking participants to choose which components they wanted to use while quitting.P = .003) more than men. Older smokers (> 26 years) and moderate smokers (15-20 cigarettes/day) utilized services more (P < .001) than younger (< 26 years) and light or heavy smokers. Satisfaction with services was high (92% to 95%) and varied somewhat with Web utilization. Thirty-day quit rates at the 6-month follow-up were 41% using responder analysis and 21% using intent-to-treat analysis. Web utilization was significantly associated with increased call completion and tobacco abstinence rates at the 6-month follow-up evaluation. We found that participants tended to use phone services more than Web services. On average, participants completed 2-2.5 counseling calls and logged in to the online program 1-2 times. Women were more adherent to the overall program; women utilized Web and phone services significantly ( This paper expands our understanding of a real-world treatment program combining two mediums, phone and Web. Greater adherence to the program, as defined by using both the phone and Web components, is associated with higher quit rates. This study has implications for reaching and treating tobacco users with an integrated phone/Web program and offers evidence regarding the effectiveness of integrated cessation programs. Telephone and Web-based cessation programs are widely available and used. Each year, approximately 1.1% to 1.7% of adult smokers receive tobacco cessation services via state quitlines across the United States .There is a large, high-quality evidence base for phone-based cessation counseling. Effectiveness has been established in dozens of large randomized trials and summarized in three meta-analyses published during the past decade -5. The CAccording to the updated Online Health Search Report  in 2006,Several real-world evaluations of QuitNet, one of the most widely used online cessation services in the United States, have been conducted. Quit rates  range from 7% to 30% at 3 months  among a population of general users (N = 1501) , to 13.2There are minimal data from randomized trials examining online cessation services. To date, results from four trials have been published. Three randomized trials have demonstrated effectiveness of online cessation approaches -13, and In the one study  incorporTo date, there are no studies that describe the efficacy or effectiveness of integrated tobacco cessation treatment including telephone counseling and online services. The purpose of the current study is to present results of an evaluation of the Quit For Life integrated phone/Web program, which is widely available through state quitlines, health plans, and employers across the United States. The Free & Clear Quit For Life phone program has been commercially available for nearly 20 years. In 2006, an interactive online program was integrated into the standard program. The integration of phone and Web modalities is a critical aspect of this novel program. The approach is that all participants are provided with a comprehensive program that includes counseling calls, online services, and printed materials. Participants do not choose between these services but receive all of them over the course of the program.The potential advantage of an integrated phone/Web program is that it offers individualized one-on-one counseling with a cessation expert in addition to the dynamic online support that can be available at any time. While phone-only and Web-only programs have their advantages, a combined program has the potential to improve outcomes and efficiency by providing tools and integrated services that appeal to a wide variety of tobacco users with different needs and learning styles. In this paper we describe (1) the characteristics of the participants using the program, (2) the phone and Web utilization rates, and (3) quit outcomes and satisfaction.This study examined the experience of 11,143 enrollees in the Free & Clear Quit For Life Program, a smoking cessation program including proactive phone-based counseling, an interactive website, and printed Quit Guides. To be eligible for this study, a participant had to be a tobacco user who spoke English, be 18 years or older, be enrolled in the program through his or her health plan or employer between May 2006 and October 2007, have access to an email account, and consent to follow-up at 6 months. State participants were excluded due to lack of systematic follow-up.The Free & Clear Quit For Life phone program has been commercially available for nearly 20 years. The program is grounded in social cognitive theory ,16 and iThe Quit For Life Program is available to participants through their employer or health plan. Participants enroll in the program directly by phone or online. Once registered, participants receive up to five one-on-one proactive phone counseling sessions, access to the interactive website (Web Coach), and printed self-help materials (Quit Guides). Phone counseling sessions are with an intensively trained tobacco treatment specialist (Quit Coach). The counseling calls are designed to provide practical expert support to help participants develop problem-solving and coping skills, secure social support, and design a plan for successful cessation and long-term abstinence. Calls are scheduled at times convenient for the caller and at relapse-sensitive intervals. Participants can also call a 1-800 number as many times as they want for additional support between calls. For all proactive counseling calls, we make up to three attempts to reach a participant for each of the ongoing, proactive calls. The number of calls completed may vary due participants declining a call or not being available to complete all calls.During each call, the Quit Coach encourages participants to use the Web program and Quit Guides to document their quit plan and track their progress. Quit Coaches have real-time access to information that participants enter on the website. This information, along with information gathered during calls, is used by Quit Coaches to frame the focus of the counseling call. The interaction between the participant, Quit Coach, and Web program is shown in                     The online component of the program (Web Coach) contains interactive tools and tailored content based on participants’ readiness to quit. As described in                                                                                Participant demographics , contract type , current tobacco use , nicotine dependence (measured as time to first use upon waking), and readiness to quit were derived from information collected at registration and the participants first call with a Quit Coach. Phone counseling  and Web use  were tracked and recorded. Participants who consented to follow-up were contacted 6 months after enrollment in the Quit For Life Program and were administered a telephone survey. Those individuals who could not be reached via telephone after 11 attempts or did not have a working telephone number were sent a mailed survey. Approximately half of the participants responded to the survey . The 10-minute follow-up survey addressed a variety of topics related to the participant’s experience with the Quit For Life Program, including program satisfaction and tobacco use behaviors/ abstinence. Abstinence data were obtained through self-report; no biochemical verification took place. Tobacco abstinence was defined as no tobacco use whatsoever in the previous 30 days. Participants were asked to rate their satisfaction with the program using a 4-point scale . Satisfaction was defined as indicating that one was “somewhat” to “very satisfied” with the Quit For Life Program services. The 30-day abstinence and satisfaction measures have been used in other published studies .The results below summarize participant demographics and program utilization.We conducted mean comparisons, chi-square analyses, and analyses of variance (ANOVA) to assess differences in counseling calls completed, Web Coach log-ins, and discussion forum log-ins by gender, age , contract type , nicotine dependence , cigarettes per day , and readiness to quit . Within ANOVA, Scheffe’s post hoc comparisons identified specific between-group differences. Within contingency table variables with more than two groups, post hoc Bonferroni chi-square comparisons examined all between-group differences.We stratified Web Coach use into three discrete categories  and conducted ANOVA to examine rates of Web use and average calls completed, satisfaction, and quit rates by level of Web use. We also classified counseling use into four discrete categories  and examined quit rates by counseling calls completed and Web log-ins (0 vs 1+ log-ins). The call level categories were derived from historical data that demonstrate different quit rates associated with these call completion levels. Since historical data were not available for Web use, we calculated three levels: no use (0 log-ins), low use (1-4 log-ins), and high use (5+ log-ins). Similar cutoff points have been used in other online studies ,14.Quit outcomes were examined using ITT analysis and responder analysis. In the ITT analysis, all participants eligible for follow-up were included in the analysis , and nonresponders to the follow-up survey were assumed to be continued tobacco users. In the responder analysis, results were based on those who responded to the follow-up survey and provided outcome information , and no assumptions were made about the tobacco status of participants lost to follow-up.Examination of the data identified several instances of very high Web utilization and discussion forum use among a small group of participants . It is notable that the distribution of program utilization data  was highly skewed. We employed a strategy of two-sided, 1% trimming, removing .05% of all values (N = 117) from both sides of these two variable’s distributions to improve the estimate of central tendency. Trimming is a well supported method for robust examination of central tendency .Participants tended to be middle aged  and were evenly distributed among genders ; 83% of study participants enrolled in the program through their employer, while the remaining 17% enrolled through their health insurance plan. On average, participants smoked 12.5 cigarettes daily (SD = 12.4). Almost all (91.7%) participants reported planning to stop smoking within 30 days of their first contact with the program.Overall, participants were less dependent on smoking than the general population of smokers. Responses to the single-item addiction index derived from the Fagerström Test for Nicotine Dependence  indicateParticipants used phone counseling more than online services. Participants completed an average of two counseling calls , utilized Web Coach an average of one time , and used discussion forums less often  than they logged in to Web Coach. However, utilization rates were much higher for those participants who engaged in phone or Web services at least once. Among those participants who took at least one telephone counseling call (N = 9376), the mean number of counseling calls was 2.5 . Among those participants who logged in to the Web services at least once (N = 5413), the mean number of Web Coach log-ins was 2.2 , and the mean number of discussion forum log-ins was 4.4 .We stratified use of Web Coach into three discrete categories: 0 log-ins (50.8%), 1-4 log-ins (43.9%), and 5 or more log-ins (5.4%). ANOVA was then used to compare counseling calls completed among the three log-in groups. For the purpose of analysis, we also stratified number of calls completed into comparison groups: 0 calls (15.9%), 1-2 calls (47.8%), 3-4 calls (28.2%), and 5 or more calls (8.2%).Demographic differences emerged among callers in terms of Web Coach and online discussion forum use, as well as number of calls completed in the cessation program. Women were significantly more likely than men to utilize online discussion forums and complete a greater number of calls. Furthermore, older callers were significantly more likely to complete more calls than younger callers. Younger callers  logged in to Web Coach significantly less often than middle-aged callers . Moderate smokers logged in to the Web Coach significantly more often than light or heavy smokers and logged in to discussion forums more often than light smokers. Callers eligible for tobacco cessation treatment through their employer were more likely to log in to Web Coach than those eligible for treatment through their health insurance plan see .Respondents who logged in to Web Coach more frequently were significantly more likely to participate in greater numbers of counseling calls. All groups differed significantly. In fact, the small number of participants (5%) who logged on to Web Coach five or more times completed on average one more counseling call than other Web Coach users. Post hoc tests confirmed that all groups differed significantly see .To assess outcomes, we examined rates of satisfaction and abstinence from tobacco for at least 30 days or more at 6 months after callers registered in the program. Among survey respondents, 92.1% were satisfied and 41.1% abstained from tobacco use for 30 days or more. When examining quit rates using the ITT analysis, the 30-day quit rate was lower (20.5%) due to attrition at follow-up.Survey respondents who logged in to Web Coach five or more times were significantly more likely to be satisfied with their experience compared to those who never logged in. No other groups differed in terms of satisfaction. Survey respondents who logged in to the Web Coach more often were significantly more likely to have been abstinent from tobacco for 30 days or more. Even when using ITT analysis, individuals logging in to Web Coach more often were significantly more likely to cease tobacco use. In both responder and ITT analyses, all groups differed significantly see . In bothχ                    2                    2 = 953.7, N = 11,143, P < .001). Specifically, for each additional call, the odds of quitting increased by 56%, whereas for each additional log-in, the odds of quitting increased by 14%.Furthermore, a multivariate logistic regression revealed that both calls completed (OR = 1.56) and Web log-ins (OR = 1.14) were significant predictors of quit outcomes (30-day ITT) when controlling for age, gender, and cigarettes per day (To our knowledge, this is the first paper to describe the utilization and outcomes of an integrated tobacco cessation phone/Web program. Quit rates were 41% among survey responders and 21% when using the more conservative ITT analysis method. Quit rates were similar to other studies involving proactive phone counseling (see meta-analysis -11. QuitThis study also extends our understanding of the use of an integrated phone/Web program. Participants completed an average of 2-2.5 counseling calls and logged in to the online program an average of 1-2 times. We found that participants tended to use phone services more than Web services. In addition, we observed that nearly half of participants never logged in to the Web Coach. The lower log-in rates for the Web program are most likely due to the automated assignment of Web access to every participant regardless of his or her interest in using the Web program. Thus, participants who chose to log in after receiving automatic access to the Web program may represent a self-selection bias toward the Internet, while nonuse may indicate a bias toward phone counseling.In a study of a worksite program with incentives, Graham et al  found thEven participants who never logged in took an average of two calls. However, participants who logged in more frequently also were more engaged in counseling by phone. Specifically, the small sample of participants who logged in five or more times took, on average, one call more than those participants who logged in fewer times. Thus, there appears to be a population of smokers trying to quit who utilize more services. Furthermore, we observed a trend for higher quit rates among participants who logged in to Web Coach at least once and took more calls. Given that this is not a randomized trial, we are unable to draw causal inferences.There were several demographic differences in utilization. Women were more likely than men to use the discussion forums and phone counseling, suggesting that women may use these services to obtain social support while quitting. Older smokers completed more calls and used the Web program more often than younger smokers. In other evaluations that we have carried out, we found that younger smokers take fewer calls. We were disappointed to find that they are less likely to use the Web Coach program as well. These findings are consistent with research that suggests that younger smokers are more ambivalent about quitting and less successful in their cessation efforts. We were somewhat surprised by the lower levels of engagement with this age group since they had proactively enrolled in the program on their own. The lower levels of engagement may suggest that younger smokers don’t realize the benefits of a program when they quit and/or that their expectations for the program were not met and thus they were less engaged. This requires further study. Japunitch et al  found noThere are some limitations that should be considered when interpreting the findings from this study. First, this is an evaluation of a real-world service and results are based on services people receive/use and not based on randomization to services. Thus, we are limited in our ability to make causal inferences regarding findings. Second, tobacco abstinence is based on self-report without biochemical verification. Since this a commercial service, biochemical verification of tobacco status is not a standard part of the services. It has not been deemed necessary in large studies of this kind and self-report has been considered adequate . Third, This study offers valuable information regarding the real-world use and effectiveness of a novel, integrated phone/Web program for tobacco cessation. Results indicate that more telephone counseling and greater use of the Web are associated with better quit outcomes. When provided access to both proactive phone counseling and Web-based services, smokers were more likely to utilize the phone over the Web. Yet those who chose to complement telephone counseling with Web services appeared to have experienced superior outcomes. Given the potential for increased efficiency and individual tailoring provided via Internet applications, and the strong evidence base for phone effectiveness, there is ample room for improvement in the development, promotion, and study of integrated approaches leveraging the phone and Web in order to further engage smokers with these modalities of treatment. Findings from this study add further support for health plans and employers to offer cessation services for their members and employees. Promoting both phone and Web-based components of an integrated program achieves the best results.


This study evaluated the Los Angeles Unified School District Nutrition Network, a large multicomponent nutrition and physical activity program in an ethnically diverse school district, launched in 2000.We calculated descriptive statistics and performed hierarchical logistic regression on school-level demographic and implementation data.Thirty-six percent of eligible schools participated in 2001, and 79% of participating schools reapplied the following year. Elementary schools and schools that applied for grant money were more likely to reapply. Produce sampling was the most frequently cited program highlight, and making purchases with program grant money was the most frequently cited challenge.Our findings suggest that schools serving students of low socioeconomic status and diverse ethnicities can be recruited into a large program to promote healthy dietary choices and physical activity, especially elementary schools. Effectiveness and institutionalization of the program might be positively affected by fostering local ownership, allowing school personnel who apply for the grant to tailor the program to their individual schools. The number of overweight children in the United States has continued to increase during the past several decades . The preOverweight prevalence among Los Angeles County public school children is estimated to be 26%, with another 19% of children at risk for becoming overweight . The LosLAUSDNN is a school-based demonstration project that promotes vegetable and fruit consumption and increased physical activity. In the 2001–2002 school year, more than 200 schools participated in LAUSDNN, with the direct involvement of 6853 teachers, 174 food service workers, 195 administrators, and 117 school nurses. LAUSDNN made its resources available to schools with kindergarten through grade 12 (K–12), who were eligible to participate if they enrolled a majority of low-income students, defined as having 50% or more students who were eligible for free or reduced-price meals through the National School Lunch Program.The major components of LAUSDNN were Harvest of the Month, the Harvest of the Month newsletter, action grants, the Chefs in the Classroom program, nutrition advisory councils, school gardening support, and individual school-generated activities. Schools applied for funding and participated in the program on a voluntary basis. Letters announcing availability of the program and funding were sent to eligible schools. LAUSD hosted a fall kick-off event at which the programs  were announced. School personnel submitted "action grant" proposals, which were likely to involve classroom-based educational and behavioral curricula, but also may have included environmental changes, parental involvement, or community involvement. Allowable action grant expenditures on physical activity included teacher guides and media encouraging physical activity. Purchase of exercise equipment was not allowed . School Nutrition networks such as LAUSDNN generally function analogously to the service-oriented tobacco-use prevention efforts of California and other states, notably Oregon. In these states, the departments that control cigarette sales tax revenue have established mechanisms for providing competitive grants for tobacco use prevention to local agencies, including school districts -11. LocaAlthough school-based curricula alone may not prevent tobacco-use initiation -13, in tDespite the potential benefits of school-based nutrition demonstration projects, formal process evaluations of obesity prevention efforts in schools have largely been a part of multisite, randomized, controlled research initiatives -19. GeneOur study, to our knowledge, is the first process evaluation of a service-oriented, rather than research-oriented, school-based nutrition and physical activity promotion effort comparable to state-initiated tobacco initiation prevention programs. Baranowski and Stables have suggested that the minimal components of a useful process analysis include examination of recruitment and retention of participants, context (environment), resources required, reach and exposure of the program, barriers, completeness and fidelity of implementation to the design of the program, continued use, and contamination . AlthougThe data were consolidated from three sources: district online school demographics , LAUSDNNThe study evaluated LAUSDNN by examining four key process evaluation indicators: recruitment, retention, program highlights, and program barriers.Obesity prevalence is higher among Latino and African American children and youth than among whites. Thus, the main independent variable of interest to us was school ethnic composition. The ethnic composition of participating schools was based on LAUSD survey data, in which student ethnicity was determined by parent identification or by the personal observation of teachers. District-wide ethnic composition of schools was derived from LAUSD . In the We conducted a retrospective cross-sectional study, using the secondary data, of the elements of the LAUSDNN implementation process in the 2001–2002 school year with individual LAUSDNN schools as the unit of analysis. Retention rates were evaluated as the reapplication to the program in the 2002–2003 school year.Recruitment of schools into the program for 2001–2002 was analyzed with a bivariate comparison, comparing ethnic composition of schools with LAUSD district-wide data. We analyzed the reapplication of schools for the next school year (2002–2003) in a multivariable framework. Frequencies are reported for program highlights and program challenges. In the multivariable analysis, we used hierarchical logistic regression to assess the associations of school characteristics with the outcome of a school reapplying to the program in the following year. Regressions were estimated as random effects models clustered by local school district. A hierarchical analysis was employed to account for unobserved factors that may have been related to the nested relationship of schools within their districts. For example, one school may have been more likely to participate because it was part of a district that had more investment in nutrition and health promotion activities.We hypothesized that program retention and reapplication was influenced by the following characteristics: ethnic composition , action grant school status, percentage of students qualifying for free or reduced-price school lunches, and school grade levels . For any given ethnicity, a school with a percentage above the sample (participating schools) median for that ethnic group was assigned a 1; otherwise it was assigned a 0. The percentage of free and reduced-price lunch was also assessed as a dichotomous variable: above the median was assigned a 1, and below the median was assigned a 0. Elementary grade schools were assigned a 1; all other schools were grouped because of insufficient numbers and given a 0.P values, and 95% confidence intervals are reported for the multivariable analyses. Bivariate analyses were conducted using Microsoft Excel , and multivariable models were estimated using STATA 8.0 .Odds ratios, In the 2001–2002 school year, 574 schools, about 80% of the district K–12 schools, were eligible for the programs. Thirty-two percent (183/574) of these schools were recruited into full program participation, including an action grant . Twenty-Nearly 80% (166/209) of the schools that participated in the program in the 2001–2002 school year reapplied to the program the next year. We compared the combined ethnic composition of the schools that continued from the 2001–2002 into the 2002–2003 school years with the schools that did not continue the program, and it was almost identical (data not shown).Results of the logistic regression analysis assessing the association of school characteristics with the schools reapplying to LAUSDNN the following year (2002–2003) are presented in Seventy-seven of the 183 schools returned lead teacher surveys . Of survChallenges cited by survey respondents are presented by frequency in P = .08, African American Students, P = .13) with reapplying to LAUSDNN, indicating that schools that serve high proportions of these two ethnic groups, which are at high risk for overweight and obesity, can potentially be retained in voluntary demonstration programs.Our study suggests several lessons from a process evaluation of LAUSDNN, a service-oriented, school-based, nutrition and physical activity promotion effort. First, such an effort shows the potential in recruiting schools serving low socioeconomic status (SES) students of diverse ethnicity. Second, the relatively high retention rate in this voluntary program suggests that some program components were well-received despite challenges in administration and purchasing. Harvest of the Month was the most often cited highlight, possibly because it was more widely used than were other components. However, the favorable reviews on generating anticipation of produce delivery, offering a participatory experience for the students, and providing fresh produce attest to the strength of Harvest of the Month. Various school-initiated programs were also cited as highlights at the schools, reinforcing the notion that local choice was a vital part of LAUSDNN. Third, our evaluation of the factors associated with retention found that elementary schools were the most likely to reapply, suggesting that program components are attractive and perhaps more suitable in the elementary school setting. Fourth, SES gradations  within these schools that already serve low-SES students did not matter when it came to retention. This suggests that retention may not be governed so much by constraints on school resources as by other factors, such as the degree of "local ownership" in a school. Fifth, and most importantly, the schools with a larger relative percentage of Latino and African American students were positively associated (Latino students, A potential criticism of offering a voluntary program such as LAUSDNN in a diverse district is that only schools with a relatively high SES will have the time and support to take advantage of the enriching resources. Although ethnicity is an imperfect proxy for SES, African American and Latino children in Los Angeles County are several times more likely to live in poverty than are non-Latino whites, with 58% of African American children and 54% of Latino children living below 200% of the Federal Poverty Guidelines compared with 16% of non-Latino white children . ImposinWe found that reapplying to the program was significantly positively associated with having an action grant versus the more passive component, participation in Harvest of the Month only. However, because the grant application mechanism was voluntary, the action grant's effect may be attributable to the greater local ownership of the program in schools that wrote grant proposals and operationalized their LAUSDNN-funded plan.Insight into local-ownership issues is provided in studies of worksite nutrition interventions, which by circumstance have offered a degree of autonomy to participants similar to those in LAUSDNN. For example, the Working Well Trial, a large multicenter cancer prevention study, used an employee at each of the worksites as coordinator, and an employee advisory board was formed to plan and implement the core interventions. This was done to enhance participation, tailor core activities, and make institutionalization more likely . The triThese data must be interpreted in light of a number of limitations. First, our findings provide lessons for school districts with an ethnically diverse, low-income student population, so they may not be generalizable to school districts with a different composition of students. The program evaluation surveys suffered from flaws that led to a low response rate and may have introduced stakeholder bias. Reducing respondent burden could increase the response rate. For example, the two surveys could be combined and simplified by replacing open-ended questions with Likert-scale ratings for highlights and challenges, now that major categories have been established. Targeting the lead teachers reduced the potential pool of respondents and emphasized the person at the school who had a tremendous investment in the program.This process analysis of LAUSDNN indicates that schools serving low SES students of diverse ethnicity can be recruited into and retained in a large nutrition and physical activity program. The effectiveness of the program and the ability to institutionalize it in schools might be positively affected by fostering local ownership, that is, allowing the school personnel who apply for the grant to tailor the program to their schools in order to promote healthy dietary choices and physical activity among their students.


Colorectal cancer is the second leading cause of cancer-related mortality among U.S. adults. In 2004, treatment costs for colorectal cancer were $8.4 billion.There is substantial evidence that colorectal cancer incidence and mortality are reduced with regular screening. The natural history of this disease is also well described: most colorectal cancers develop slowly from preexisting polyps. This slow development provides an opportunity to intervene with screening tests, which can either prevent colorectal cancer through the removal of polyps or detect it at an early stage. However, much less is known about how best to implement an effective colorectal cancer screening program. Screening rates are low, and uninsured persons, low-income persons, and persons who have not visited a physician within a year are least likely to be screened.Although the Centers for Disease Control and Prevention (CDC) has 15 years of experience supporting the National Breast and Cervical Cancer Early Detection Program for the underserved population, a similar national program for colorectal cancer is not in place. To explore the feasibility of implementing a national program for the underserved U.S. population and to learn which settings and which program models are most viable and cost-effective, CDC began a 3-year colorectal cancer screening demonstration program in 2005.This article describes briefly this demonstration program and the process CDC used to design it and to select program sites. The multiple-methods evaluation now under way to assess the program's feasibility and describe key outcomes is also detailed. Evaluation results will be used to inform future activities related to organized screening for colorectal cancer. Cancer is the second leading cause of death among U.S. adults, and colorectal cancer is the second leading cause of cancer-related deaths among U.S. men and women. In 2004, there were 145,083 new cases of colorectal cancer, and 53,580 people died of the disease  has 15 years of experience supporting the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) for the medically underserved population, but a similar national program for colorectal cancer is not in place . The NBCPreventing Chronic Disease   recommenThe selected test or tests are recommended by USPSTF.The applicant has the capacity to offer the selected test or tests.Providers within each selected program would be reimbursed for screening and diagnostic tests at the Medicare rate.The focus of the screening programs would be on people aged 50 to 64 at average risk for colorectal cancer; younger persons would be eligible if they are at increased risk.Persons at increased risk for colorectal cancer because of a personal or family history of the disease would be eligible to receive screening services.Persons with colorectal cancer symptoms or at high risk of colorectal cancer because they already have inflammatory bowel disease or certain genetic conditions would not be eligible to receive services, because these conditions require frequent specialized care.Programs would need to convene a local medical advisory board to address ongoing clinical issues.As with the NBCCEDP, CDC funds would not be used for cancer treatment. To be eligible for consideration, applicants had to identify, in advance, sources that would provide treatment services for 1) cancers detected through the screening program and 2) complications that may arise during screening and diagnostic procedures.Of the 39 applicants who competed for funds to start a demonstration project, 5 were selected and awarded a combined $2.1 million for year 1 of a 3-year program beginning in 2005. The successful applicants were the Maryland Department of Health and Mental Hygiene; Missouri Department of Health and Senior Services; Nebraska Department of Health and Human Services; Public Health – Seattle & King County, Washington; and Stony Brook University Medical Center, New York. The program's structure and the screening tests selected for the program are described in Preventing Chronic Disease , a data user's manual, data collection forms, a readiness checklist, a cost-assessment tool, and an evaluation plan. The cost-assessment tool and evaluation plan are described in another article in this issue of  Disease . The reaCDC created a policy manual for this demonstration program. Each site also created its own individual policies, which usually mirrored the policies that CDC created for the overall program. Policies were developed on the following topics: 1) patient eligibility, 2) reimbursement, 3) reporting adverse events, 4) collecting and reporting data, and 5) medical advisory committees. A series of supporting documents to accompany the policy manual were developed by CDC in collaboration with all sites. These documents include guidelines for patient eligibility and ineligibility, reimbursable clinical services, data reporting requirements and schedules, and service quality indicators. These indicators were developed to capture data on the characteristics of the population being served by the program, the completeness of clinical follow-up and treatment, and the timeliness of clinical follow-up and treatment.The CCDEs were developed by CDC, program sites, and two external clinical experts to ensure that information collected about clients' demographic characteristics, screening history, risk factors, screening and diagnostic tests, final diagnosis, and treatment would be consistent and complete. These data will be used to monitor the extent to which the five demonstration sites achieve the objectives of the demonstration project. They will also be used to guide future policy and program development. CDC provided technical assistance on data management and reporting to each of the five sites through routine communication and through tools that promote standard reporting, including a communication Web site for program participants, an extensive data dictionary, and software to validate the data set being submitted. Because of the short time frame and limited number of awardees participating in the program, we did not provide a standard data management system. Several measures were taken to emphasize the importance of delivering high-quality clinical services. Programs were made aware of important quality issues, including the frequent and inappropriate use of in-office rather than at-home fecal occult blood tests (FOBT) , wide vahttp://www.cdc.gov/cancer/colorectal/sfl/) is a multimedia campaign that promotes colorectal cancer screening for adults aged 50 years or older. Programs were not required to use SFL materials, but materials that could be adapted for local use were developed by CDC staff and made available to the five programs. During start-up, two sites used the SFL materials and worked with CDC to adapt the SFL logo for their own program's use. Later, a third program elected to use SFL materials for patient education.CDC's Screen for Life: National Colorectal Cancer Action Campaign (SFL)  to be used during start-up to assist CDC and the five sites to monitor progress toward implementing the program. The items in the checklist corresponded to program components and include providing screening and diagnostic follow-up services, public education and outreach, data collection and tracking, patient support, partnership development and maintenance, quality assurance and professional development, and program management.CDC developed a readiness checklist  to analyze patient screening and diagnostic services, 2) to determine cost and cost-effectiveness, and 3) to conduct a longitudinal multiple-case study.) are planning to allocate new resources for organized colorectal cancer screening programs. CDC is working closely with the five demonstration program sites and communicating with other local and state partners who are taking steps toward establishing local or state programs so that lessons learned can be disseminated widely. Several pieces of legislation have been introduced into the U.S. Congress that, if passed, would establish a national colorectal cancer screening program.Colorectal cancer screening is rapidly becoming a priority at the local, state, and national levels. Several states  have long-standing programs; other states and cities  recently began colorectal cancer screening; and others (e.g., Iowa, WyomingPreventing Chronic Disease (Program activities for the demonstration sites will continue through August 2008. The evaluation findings published in this issue of  Disease -15 and f


Tobacco mosaic virus (TMV) is a plant virus with a highly ordered organisation and has been described in three different structural states: As stacked disks without RNA , as a helical form with RNA (X-ray fibre diffraction) and as a second distinct helical form with RNA (cryo-EM). Here we present a structural analysis of TMV as a test object to assess the quality of cryo-EM images recorded at 300 keV on a CCD camera. The 4.6 Å TMV structure obtained is consistent with the previous cryo-EM structure and confirms that there is a second helical form of TMV. The structure here also shows that with a similar number of TMV segments an equivalent resolution can be achieved with a 4k CCD camera at 300 keV. In recent years the resolution achievable by single particle cryo-EM has improved due to modernisation in both data collection and image processing. Data quality has been improved by the use of more stable stages, field emission guns and automated procedures used to collect very large data sets . The devDigital recording of images has become a standard method in cryo-EM labs. CCD cameras have been shown to have a higher signal-to-noise ratio (SNR) at low-to-intermediate resolutions (25–10 Å) than photographic film but a lower SNR at high resolutions (beyond 10 Å) . HoweverAn advantage of CCD cameras is that at low electron doses the signal transfer is more linear than that of film which provides a more correct representation of the beam intensity . This imIn this study we used TMV to test whether a near atomic resolution structure can be obtained using a commercially available 4k × 4k CCD camera with an ultra sensitive scintillator to collect cryo-EM images at 300 keV. TMV is a highly ordered plant virus. Mature TMV is approximately 3000 Å in length and 180 Å in width, with a 40 Å central channel, and consists of RNA and multiple copies of a 17.5 kDa coat protein (CP). It has been found in different conformational states by X-ray crystallography at 2.5 Å (stacked disks conformation), X-ray fibre structure at 2.9 Å  and cryo-EM at 4.7 Å  . The CP The resulting EM density map of TMV at 4.6 Å demonstrates clearly that near atomic resolution structure is feasible for non-icosahedral particles at 300 keV with a 4k CCD camera. This structure is consistent with the previous cryo-EM structure, showing the same conformation in the LR region and a similar resolution.2We started our analysis by extracting 5300 TMV segments from 104 manually collected CCD frames, equivalent to 260 000 asymmetric subunits (ASU). In order to reduce noise the segments were initially 2 × 2 averaged to give 2.48 Å/pixel at the specimen level. The magnification was determined using the computed diffraction patterns of the TMV images and known periodicity of the virus. The image processing was done using a similar method to that described by 10 helix, Arg92-RNA contact and a similar inner loop conformation are seen in both cryo-EM maps  of the reconstruction, extended almost to the Nyquist limit (∼5 Å) . Therefo-EM maps . However-EM maps . In orde-EM maps  to modifThe fit of the refined structure into the cryo-EM density map showed more of the side chains and the main chain of the inner loop were in density . Inspect2 and the sample was maintained at room temperature. The sample in the previous study had no salt, included EDTA and was maintained at 4 °C. However, the observed differences are small for this helical conformation of TMV.The small structural differences between our map and the previous cryo-EM study  may be explained by differences in sample conditions: TMV structure is known to be sensitive to ionic conditions and temperature . In thisIn conclusion our results demonstrate that it is possible to reveal side chains in structures determined form cryo-EM images collected at 300 keV on a 4k × 4k standard CCD camera used at full resolution, using single particle analysis with helical symmetry. This is also the first non-ichoshedral virus structure that it has been possible to resolve side chains using a CCD camera. We have also confirmed that the second helical form of TMV previously reported by cryo-EM is the solution state of the virus. Our results corroborate that the use of commonly produced cameras  open a road to high-throughput in EM structural analysis.33.1The TMV was provided by Dr. Jan W.M. van Lent from the Laboratory of Virology, Wageningen, Netherlands and was purified and assembled as described by Gooding and co-workers .3.22. 3.5 μl of the TMV was applied to C-flat grids , which had been rendered hydrophilic by glow discharge in air. The grids were then blotted and frozen in liquid nitrogen cooled liquid ethane.TMV was diluted to a final concentration of 3 mg/ml in 50 mM Tris–HCl (pH 7.4), 50 mM KCl, 10 mM MgCl−/Å2) were manually recorded from two grids on a Tecnai Polara electron microscope  operated at 300 keV, using a Gatan Ultrascan 4000 4k × 4 k CCD camera with an ultra sensitive phosphor scintillator . A calibrated magnification of 121 000× and a defocus range between 0.9 and 3.0 μm underfocus were used during data collection. Magnification was calibrated using the first layer line from power spectra of multiple TMV particles. The four quadrants of the CCD camera had been equalised and the images were gain normalised and dark corrected.Low dose images . After each round of alignment the images that had aligned to the same reference were averaged and their symmetry-related views calculated using TMV’s helical parameters:2 between 10 and 4 Å and therefore −155 Å2 was used to scale amplitudes. The combination of a finer angular spacing and the use of the B-factor improved the EM density so that both the main chain and side chain densities were better resolved.Once the angle assignment had stabilised the resolution of the map was estimated by the Fourier shell correlation (FSC) and found to be 4.6 Å at the 0.5 FSC criterion. The two reconstruction used in the FSC calculation were generated separately by splitting the final average and symmetry-related views into even and odd numbers. In the final reconstruction the full CTF correction was done in SPIDER to correct for the envelope function of the microscope. An envelope parameter of 0.25 was used in SPIDER  to model3.4The 2TMV and 2OM3 structures were docked into the final map using Chimera . It was 3.5Both the cryo-EM density map and the atomic coordinates have been deposited in the EMDB and PDB with accession codes EMD-1730 and 2XEA.


International Medical Graduates (IMGs) training within the Canadian medical education system face unique difficulties. The purpose of this study was to explore the challenges IMGs encounter from the perspective of trainees and their Program Directors.Program Directors of residency programs and IMGs at the University of Toronto were anonymously surveyed and asked to rate  the extent to which specific issues were challenging to IMGs and whether an orientation program  should be implemented for incoming IMGs prior to starting their residency.Among the IMGs surveyed, Knowledge of the Canadian Healthcare System received the highest mean score (3.93), followed by Knowledge of Pharmaceuticals and Hospital formularies (3.69), and Knowledge of the Hospital System (3.69). In contrast, Program Directors felt that Communication with Patients (4.40) was a main challenge faced by IMGs, followed by Communication with Team Members (4.33) and Basic Clinical Skills (4.28).IMGs and Program Directors differ in their perspectives as to what are considered challenges to foreign-trained physicians entering residency training. Both groups agree that an orientation program is necessary for incoming IMGs prior to starting their residency program. Several studies note that International Medical Graduates (IMGs) experience additional problems relative to their Canadian counterparts such as loneliness, social isolation, concerns related to family members left behind in home countries, a decrease in social status with an accompanying diminishment of self-esteem, lack of financial resources and worries about visas/immigration issues ,3. AlthoHowever, most orientation programs tend to concentrate on a specific skill, namely communication or cultural-sensitivity training. In a pilot study conducted at one Canadian medical school, IMGs participated in an 18-hour communication program, focusing on doctor-patient and doctor-colleague interaction during the first year of residency. Although the sample size was small, self-evaluations scores showed significant improvement after these sessions . In anotIn light of this, a needs assessment study was conducted at the University of Toronto to explore the extent that these specific issues were challenging for IMGs in a residency program from the perspective of Program Directors and foreign-trained physicians themselves.Separate surveys were created for IMGs and Program Directors using iterative input from an expert panel of three faculty members. These individuals have worked with IMGs over the past four years with particular emphasis on mentoring, teaching and developing remediation plans.Ten common issues were posed to both groups and covered the following three topics: Clinical Knowledge and Skills (3), Communication and Working Relations (4), and Macro Issues (3). These issues were identified by the expert panel as being the most pertinent and common across all subspecialties. For the purpose of this study, Macro Issues were defined as areas of concern affecting institutional, environmental or cultural experience and performance.Currently, there is limited research exploring the impact of macro-level issues as challenges to the medical training of IMGs. Adapting to a new environment involves much more than learning how to communicate effectively. Essentially, the culture and principles, as well as the rules and procedures inherent in everyday operations of an organization, must be learned. Whether this translates to learning how to request a MRI or how to use software to track a patient's medical records, experiencing difficulty in adapting to a new environment may be mitigated by learning about these issues. Hence, under this premise, the survey included macro-level issues such as knowledge of the Canadian Healthcare System, knowledge of the hospital system  and hospital and pharmaceutical formularies.Using a 5-point Likert scale, IMGs indicated to what extent each issue posed as a challenge to them during their residency. Program Directors were asked to what extent these issues were challenges to IMGs using the same scale. Further, both groups were asked whether an orientation program, in the form of a horizontal curriculum, was necessary for incoming IMGs. For this study, a horizontal curriculum is defined as a course of study with specific learning objectives for the purpose of obtaining a goal (i.e. providing a smoother transition of IMGs into residency programs at the University of Toronto).In the 2005 – 2006 academic year, a total of 118 IMGs were enrolled in all residency programs at the University of Toronto, as identified through the Postgraduate Medical Education registration database. IMGs were defined as individuals (regardless of citizenship status and source of funding) who obtained their medical degree outside of Canada at an accredited medical school, and training in a residency program recognized by the Royal College of Physicians and Surgeons of Canada and/or the College of Family Physicians of Canada. With the University of Toronto being the largest medical school in Canada offering almost all specialty and subspecialty residency training programs, 73 residency Program Directors were identified as potential participants.Due to the number of IMGs and the difficulty in recruiting (i.e. multiple training sites), email invitations were sent out which included a link to complete the survey on-line. To increase the response rate, residents were given the option to include their email address for a chance to win an iPOD.Email invitations were sent out to all Program Directors with the survey attached, as well as instructions on how to complete the on-line questionnaire. In the event that the former was chosen, Program Directors were given the option to fax or email completed surveys. To encourage the participation of Program Directors, these multiple accommodating methods were offered. Three follow-up emails were sent to IMGs and two follow-up emails were sent to Program Directors.Participation for both groups was voluntary and subjects were given the option to withdraw at any time. Ethics approval was obtained by the University of Toronto Research Ethics Board for this study.Frequencies for all eleven close-ended questions were calculated, as well as the mean rating for each of the 10 Likert-scale questions.The response rate for IMGs was 74% (87 out of 118) and the response rate for Program Directors was 62% (45 out of 73). Mean scores for all ten topics and corresponding standard deviations are presented in Table Among the IMGs surveyed, Knowledge of the Canadian Health Care System received the highest mean score, followed by Knowledge of Pharmaceuticals and Hospital formularies (3.69), and Knowledge of Hospital Systems (3.69). The lowest mean rating scores were Basic Clinical Skills (2.78), Working Relations with Other Residents (3.05) and Working Relations with Other Healthcare Students and Allied Healthcare Professionals (3.13).In contrast, the three highest mean scores among Program Directors were Communication with Patients (4.40), Communication with Team Members (4.33) and Basic Clinical Skills (4.28). The lowest mean scores were Knowledge of Hospital Systems (3.19), Specialty-specific Clinical Knowledge (3.37), and Specialty-specific Clinical Skills (3.46). Mean scores for Program Directors were higher relative to IMG trainees for all challenges presented in two categories: Knowledge and Skills and Communication and Working Relations. Mean scores for all Macro Issues were lower among Program Directors relative to the mean scores of IMGs.Approximately three-quarters of all participants agreed that an orientation program specifically targeted for IMGs is needed. When broken down by group, 93% of all Program Directors surveyed believed that an orientation program was necessary. A smaller majority (63%) of IMGs believed such a program would be beneficial.Among the IMGs and Program Directors surveyed at our medical school, the majority agreed that an orientation program for all IMGs is required before starting a residency program. Such a program is currently provided for IMGs in the Faculty of Medicine and is reported to be insufficient . This finding is supported by previous work conducted in the United States. Mylonakis, Mega, and Schiffman  found thMean scores for Basic Clinical Skills differed between IMGs and Program Directors and may be related to the variability of training IMGs possess prior to entering the Canadian medical education system. With regards to Communication and Working Relations, mean scores were relatively higher among Program Directors, which may indicate they are more concerned with the communication skills and interprofessionalism of IMGs, in comparison to IMGs themselves. This is consistent with previous literature ,7.These findings are not exclusive to foreign-trained physicians. Yahes and Dunn  found thAll three Macro-level Issues  received the highest mean scores among IMGs. System issues may prove especially challenging to IMGs who are required to learn the values of a new country's healthcare system and the culture of a hospital and its numerous administrative protocols, in addition to their medical curriculum. Program Directors may feel such issues are not challenges or may only view these as pertinent once the trainee begins his/her residency.These concurrent surveys of IMG residents and their Program Directors at the University of Toronto illustrated that both cohorts feel that IMGs need better integration into their residency programs. Interestingly, the groups differed in the areas of concern with residents acknowledging their anxiety about a lack of knowledge and comfort in many macro areas, namely institutional and societal transition areas, whereas Program Directors were more concerned with areas of performance indicators in communication, collaboration and basic clinical skills. Each group responded based on their needs and anxieties, possibly indicating that they need to be educated about each other's perspectives.IMGs are forming a major part of our training cohort, thus representing an increasing number of physicians entering into practice as a short-term solution to health human resource needs. A proliferation of IMG entries has not been accompanied by robust strategies to optimize their integration and bridge their transition into residency. In this study, IMGs have identified specific challenges as have their Program Directors. A comprehensive and integrated program is needed to facilitate the success of IMGs.The project was designed as a needs assessment study to explore the extent to which specific issues were challenging to IMGs from the perspective of IMG trainees and Program Directors. As it stands, the survey instrument has only face validity.Secondly, this study is exploratory in nature. As the survey only provided pre-selected issues, participants were restricted in ranking the choices presented. Follow-up studies using focus groups with IMGs may help to expand on their experiences or uncover specifics that cannot be captured using close-ended questions. The same qualitative methods should be used to explore the perceptions of Program Directors, not only for contrast, but also to identify other issues that may not be shared by the IMG cohort.Conclusions of this study are specific to the perceptions of IMGs and Program Directors of medical residency programs at the Faculty of Medicine at the University of Toronto. It cannot be concluded that IMGs and Program Directors at other Canadian medical schools or elsewhere perceive these issues as challenges, or to the same extent as those who participated in this study.Funds have been received from the Ontario Ministry of Health by the Postgraduate Medical Education Office to design an Orientation Program for incoming IMGs. Results from this study were strictly used as one component to assist the Director of Education and Research in designing the program. No formal report of this study has been disseminated to this funder or other sponsors.The Postgraduate Medical Education Office is financing this manuscript, including the article-processing fee. This office employs both Dr. Sarita Verma, Vice-Dean, and Rachelle Zulla, Research and Data Analyst. Dr. Baerlocher is currently a resident in the Department of Medical Imaging. None of the contributing authors hold stocks or shares in this organization and no patents related to the content of the manuscript have been submitted. All authors declare that they have no competing interests.SV is responsible for the conception and design of this study, as well as critically revising the final draft. The acquisition of data, analysis and interpretation of data, as well as writing and editing the final version, was done by RZ. MOB contributed by interpreting the data and contributing to writing the final version of this paper. All authors have read and approved this manuscript.The pre-publication history for this paper can be accessed here: