Chronic fatigue syndrome, also known as ME (CFS/ME), is a condition characterised primarily by severe, disabling fatigue, of unknown origin, which has a poor prognosis and serious personal and economic consequences. Evidence for the effectiveness of any treatment for CFS/ME in primary care, where most patients are seen, is sparse. Recently, a brief, pragmatic treatment for CFS/ME, based on a physiological dysregulation model of the condition, was shown to be successful in improving fatigue and physical functioning in patients in secondary care. The treatment involves providing patients with a readily understandable explanation of their symptoms, from which flows the rationale for a graded rehabilitative plan, developed collaboratively with the therapist. The present trial will test the effectiveness and cost-effectiveness of pragmatic rehabilitation when delivered by specially trained general nurses in primary care. We selected a client-centred counselling intervention, called supportive listening, as a comparison treatment. Counselling has been shown to be as effective as cognitive behaviour therapy for treating fatigue in primary care, is more readily available, and controls for supportive therapist contact time. Our control condition is treatment as usual by the general practitioner (GP).This study protocol describes the design of an ongoing, single-blind, pragmatic randomized controlled trial of a brief (18 week) self-help treatment, pragmatic rehabilitation, delivered by specially trained nurse-therapists in patients' homes, compared with nurse-therapist delivered supportive listening and treatment as usual by the GP. An economic evaluation, taking a societal viewpoint, is being carried out alongside the clinical trial. Three adult general nurses were trained over a six month period to deliver the two interventions. Patients aged over 18 and fulfilling the Oxford criteria for CFS are assessed at baseline, after the intervention, and again one year later. Primary outcomes are self-reported physical functioning and fatigue at one year, and will be analysed on an intention-to-treat basis. A qualitative study will examine the interventions' mechanisms of change, and also GPs' drivers and barriers towards referral. Chronic fatigue syndrome, also known as ME (CFS/ME), is a symptomatically-defined condition in which the main complaint is medically unexplained fatigue, lasting at least six months, and of sufficient severity to impair the patient's functioning substantially ,2. The eA 2001 systematic review of all treatments for CFS/ME concluded that cognitive behaviour therapy (CBT) and graded exercise therapy (GET) were the most promising treatments for CFS/ME, but that owing to the small number of studies available for review, the generalisability of these results could not be assured . The autIt has recently been suggested that more research is needed before we can be confident that effective secondary care treatments for CFS/ME can be extrapolated to primary care . A randoTo our knowledge, therefore, no adequately controlled trial of treatment for chronic fatigue syndrome in primary care has been published to date. Those treatments that have been shown to be effective in secondary care are not widely available. If a brief, readily communicable and easily implementable treatment could be shown to be clinically effective and cost effective in primary care, this would benefit the large proportion of patients who currently receive no effective treatment, including patients who might have difficulty accessing secondary care services.We previously reported on a large-scale hospital-based trial in Liverpool, with out-patients suffering from CFS/ME, of a treatment termed "pragmatic rehabilitation" . The treIn the Liverpool trial, three treatment groups received the manual and varying amounts of contact with a therapist over a three-month period; either nine face-to-face sessions (maximum treatment), two face-to-face sessions and seven telephone calls, or two face-to-face sessions only (minimum treatment). Results showed that all of these treatments were very effective when compared with medical assessment and advice: 57% of patients in the treatment groups no longer fulfilled case criteria for CFS 12 months after starting treatment, as compared with 6% of patients in the control condition . AnalysiOur results  indicateThis study was designed to address four principal research questions:(1) Is pragmatic rehabilitation, delivered at home by nurses to CFS/ME patients recruited from primary care, a clinically effective intervention in terms of reduced disability and fatigue when compared with treatment as usual delivered through the primary care team?(2) Is supportive listening, delivered at home by nurses to CFS/ME patients recruited from primary care, a clinically effective intervention in terms of reduced disability and fatigue when compared with treatment as usual delivered through the primary care team?(3) Which of the three treatments, pragmatic rehabilitation, supportive listening and treatment as usual, is the most cost-effective?The study will also address three further issues: the relative efficacy and cost-effectiveness of pragmatic rehabilitation and supportive listening; the mechanism of action of these treatments; and barriers to the implementation of these treatments in UK primary care settings.This is a single-blind pragmatic randomised controlled trial of a brief (18-week) self-help treatment, called pragmatic rehabilitation, for CFS/ME patients recruited from primary care, delivered by three specially trained nurse-therapists in the patients' homes, and compared with both nurse-therapist delivered supportive listening, a comparison treatment that also controls for therapist contact time, and treatment as usual by the General Practitioner.The study is currently taking place across the North West of England. Patients are referred to the trial by their general practitioners and assessed in their own homes. If randomised to pragmatic rehabilitation or supportive listening, patients are treated at home.This study has been reviewed and approved by the Eastern MREC (reference 03/5/62)The three nurse-therapists delivering the pragmatic rehabilitation and supportive listening treatments were employed specifically to work on this trial. We decided to recruit three nurses  with an interest in psychosocial aspects of health care , who were used to working in the community and primary care, and who could manage medical co-morbidity, in order to develop a treatment that could be made widely available. Primary care general nurse practitioners have been successfully trained to implement interventions based on cognitive behaviour therapy for patients who were high utilisers of medical care and had medically unexplained symptoms  and irriTraining of the nurse therapists to deliver both interventions took place over a six-month period. Training in each intervention took place over a period of four months. Training in the supportive listening intervention started first. After two months, training in the pragmatic rehabilitation intervention started, so that there was a period of overlap when both interventions were being taught and practised together.Training in the supportive listening treatment was provided by an experienced counsellor with expertise in the client-centred counselling approach, and was supported by a training manual specially written for this study. Sixteen half-days of training were provided, in which the nurse-therapists were introduced to the techniques and concepts of client-centred counselling, and developed and practised new skills using exercises, discussions and role-plays.Sixteen half days of training in the techniques of pragmatic rehabilitation were delivered over a twelve week period by members of the trial team, working with the extensive training materials developed by Dr. Pauline Powell. A particular focus of the pragmatic rehabilitation training was on teaching the nurses to work with the patient manual and on equipping the nurses with the necessary skills to enable patients to use the manual effectively. Audio-taped role-play and other practical exercises were used. During the training period, the nurse-therapists also "shadowed" Pauline Powell and her co-workers in the hospital setting in order to gain additional experience.The nurse therapists were provided with diaries to record their achievements during the training period. Before the nurses started treating patients, they practised the skills that they had learned in training by delivering the scheduled treatments to four volunteer patients each. These sessions were audiotaped (with the patients' permission) and the tapes, together with material generated by the patients and the nurses, were assessed to evaluate nurses' practice in accordance with pre-defined criteria relating to knowledge, skills and attitude .The nurse therapists are receiving regular supervision while they are treating patients. For the pragmatic rehabilitation arm, supervision is provided by two members of the trial team, while supervision for the supportive listening arm is being provided by a counsellor experienced in supervision. In both arms, there is a mixture of group and individual supervision sessions, and supervision takes place at approximately two-weekly intervals. Booster training sessions are being provided in both treatment arms at approximately four-monthly intervals.not excluded. Patients with comorbid conditions  that might be exacerbated by the activity programme are not excluded, but the advice given to them is tailored accordingly.Patients aged 18 and over who fulfil the Oxford criteria for CFS , but at There are three treatment arms: pragmatic rehabilitation, supportive listening, and treatment as usual by the general practitioner. Three nurse-therapists deliver the pragmatic rehabilitation and supportive listening treatments in patients' homes and via telephone calls. All three nurse-therapists deliver both treatments. Each patient in the pragmatic rehabilitation and supportive listening arms is treated by only one nurse therapist. The schedule of therapist contact is identical in the two treatment arms. The treatment period is eighteen weeks.Pragmatic rehabilitation and supportive listening treatments each consist of five face-to-face sessions delivered in the patient's home , interspersed with five 30-minute telephone calls to the patient , in accordance with a standard operating protocol. The first face-to-face session lasts approximately 90 minutes, while the other four face to face sessions last approximately 60 minutes. The telephone calls last a maximum of 30 minutes. A record is kept of the dates on which treatment sessions are delivered, and of the length of each session.We needed a longer first face-to-face session to allow time for the delivery of the rationale for pragmatic rehabilitation and supportive listening. While two face-to-face sessions with the therapist were effective in the Liverpool secondary care trial , patientThe first intervention session is taken up with providing patients with a detailed explanation of their symptoms in terms of such physiological explanations as circadian rhythm desynchronisation, disrupted sleep patterns, neuro-endocrinological disturbances, and cardiovascular and muscular deconditioning. The somatic manifestations of anxiety are also explained to the patient. The patient is given the manual at this session. Our experience is that this initial session, which provides patients with convincing explanations for their symptoms and also indicates how they can be targeted in treatment, is crucial to the success of the intervention; in the Liverpool trial the majority of patients rated this component as very helpful on a follow-up questionnaire . PatientWe recognise that patients with CFS/ME often feel misunderstood or disbelieved, so an important part of any non-specific treatment effect might be attributable to the patient feeling that his or her symptoms are being taken seriously, and that his or her status as an ill person is accepted. The aim of the supportive listening treatment arm is to provide emotional support and validation for the patient through the development of a collaborative relationship in which the patient is held in unconditional positive regard, and encouraged to talk about his or her experience of CFS/ME and problems which he or she has in dealing with it. The content of patient-therapist discussions is largely determined by the patient. In order to provide parity with the pragmatic rehabilitation intervention, patients in the supportive listening arm are provided with a short manual that explains the principles of client-centred counselling, provides suggestions as to how to get the most out the treatment, and includes diary pages for the patient to record his or her own thoughts and feelings.GPs usually try to talk to patients such as these about their symptoms in an unstructured way, investigate, provide reassurance, prescribe symptomatic relief, prescribe hypnotics, sedatives and anti-depressants, and refer. For this trial, GPs are advised on how to assess CFS/ME patients, and asked not to refer to specialist services for systematic psychological therapies for CFS/ME during the eighteen week treatment period, but are otherwise invited to manage their allocated cases as usual in the way that they see fit. Treatment received by patients from their GPs will be determined at the end of the trial by examination of GP records, and patients will also be asked about the care they received at the 20 and 70 week assessments.All three therapists deliver both the pragmatic rehabilitation and the supportive listening treatments. We chose this approach rather than having different therapists delivering the different therapies in order to reduce the confounding of therapist effects. We have a good track record in trials of CFS/ME  and otheExperience from the Liverpool study suggests that patients who accepted the rationale for treatment were willing to adhere to it. In the Liverpool study, treatment was completed by 127/148 patients; i.e. a drop-out rate of only 14%. On the other hand, in a trial of cognitive behaviour therapy versus counselling for fatigue in primary care , 44/193 In the Liverpool study, 148 patients were randomised to treatments; each was scheduled to receive four assessments by postal questionnaire , making a total of 592 assessments in all. At the end of the trial, 541 of these assessments had been completed (including those completed on drop-outs), giving a loss to follow up of only 9%. Our patients will be required to complete a larger battery of assessments than those in the Liverpool study, which might reduce participation rates. On the other hand, we anticipate that the fact that interventions and assessment will take place in the patients' homes in this trial will reduce both failure to adhere to treatment and failure to complete assessments. To ensure that we have sufficient numbers to test our hypotheses, we have estimated a rate of 23% combined non-compliance and loss to follow-up , after stratification based on whether the patient is ambulatory or not (not ambulatory being defined as using a mobility aid on most days), and on whether the patient fulfils London ME criteria or not. There are therefore four strata in total. Where applicable, patients are assigned to therapists in a simple random fashion according to the therapists' availability. The trial manager is informed of randomisation, and group membership is conveyed to the designated nurse-therapist, if appropriate. The GP is informed of randomization and sent a copy of the patient consent form.Patients are assessed at entry to the trial (week 0), within one week of the end of treatment (20 weeks), and then one year after finishing treatment (70 weeks). Assessments are carried out by trained researchers who are blind to the arm to which the patient has been randomised. Assessment at week 70 is required because short-term assessments of outcome in a chronic health condition such as CFS/ME can be misleading. Additionally, psychological treatments such as CBT become more effective over time  and we wThe primary outcome measures are patient-rated to avoid observer bias. These are (1) score on the physical functioning scale of the SF-36 , (2) cosSecondary outcome measures are (1) time to take 20 steps,  and maximum heart rate reached on a step-test ; (ii) scIn the Liverpool study, scores on the HADS predicted changes in the primary outcomes, physical functioning and fatigue. As lack of social support has been implicated in symptom persistence in chronic fatigue syndrome , we inclFour phases of qualitative interviews are being carried out with sub-samples of patients and GPs. These will explore GP and patient attitudes to CFS/ME, its current management, and the trial interventions. In addition, we will determine the mechanisms of action of the interventions and identify barriers to their implementation. The composition of the samples will mirror that of the quantitative study, with representatives of all three treatment groups, study participators and study refusers, while the exact size of the sub-samples will be determined during the course of analysis using the constant comparative technique . The firA full economic evaluation is being undertaken alongside the clinical trial. The economic evaluation takes a societal viewpoint, but will also disaggregate data to enable us to examine implications for specific sectors such as primary and secondary care within the NHS as well other government agencies . Resource-use data detailing the use of primary and secondary care services, social and community services, private and voluntary services are collected at each assessment point. Unit cost estimates will then be applied to each resource, using figures from local providers supplemented by national data where appropriate. For each patient in the trial, a total cost will be estimated by calculating the product of resource use and the relevant unit cost. In addition, cost to patients (e.g. travel costs) will be estimated at 70 weeks. Cost data will be analysed using appropriate statistical techniques, such as bootstrapping, and will also be subjected to extensive sensitivity analysis. A cost-utility analysis will be performed using the EQ5D  as a meaThe power analysis for this trial has been based on the effects expected in the clinical measures. To address the issue of the adequacy of the sample size to perform the economic evaluation, methods of presenting data that allow for the uncertainty created by potentially under-powered economic evaluations, such as cost-effectiveness acceptability curves, will be employed. These techniques allow for the cost of the uncertainty to be estimated and therefore the value of future data collection can be assessed.2 test with a 0.05 two-sided significance level will have 80% power to detect the difference between an intervention group proportion of 50% improved and a treatment as usual group proportion of 30% improved, when the final sample size is 93 per group. Allowing for a rate of loss to follow-up of 23% in the treatment as usual group, the sample size required is 120 per group.We plan to recruit 120 patients for each treatment arm. Our power calculation was based on a comparison between pragmatic rehabilitation and treatment as usual. In the Liverpool hospital-based study , at 12 mAnalysis of both the quantitative and qualitative data collected during the course of the trial will take place in accordance with pre-determined analysis plans, which have been lodged with the Data Monitoring and Ethics and Trial Steering Committees.Baseline comparability of the three treatment groups will be described, but no significance testing will be conducted. Acceptance of and adherence to treatment will be described. Patients in the pragmatic rehabilitation and supportive listening arms will be deemed to have accepted treatment allocation if, after randomization, they embark on treatment, that is they make themselves available for the first treatment session. Patients in the treatment as usual arm will be deemed to have accepted treatment if, after randomization, they agree to return to their GP's care. To measure adherence to treatment, in the pragmatic rehabilitation and supportive listening arms, the number of home visit sessions and number of telephone calls that in the opinion of the therapist constituted an intervention session will be counted. No attempt will be made to assess adherence further than this. In the absence of any protocol violation , patients in the treatment as usual arm will be deemed to have adhered to treatment. Missing outcome data will be described in relation to patient baseline characteristics and adherence to treatment.Descriptive statistics for outcome measures will be presented. The main analyses will be carried out using all patients randomized using the principle of Intention-To-Treat (ITT). With three groups  we will have two degrees of freedom to test for group differences. Following a global test to determine whether the three groups are different, pragmatic rehabilitation will be contrasted with supportive listening. If there is no evidence of any difference in outcome between pragmatic rehabilitation and supportive listening, they will be jointly contrasted with treatment as usual. If pragmatic rehabilitation and supportive listening differ in their outcomes, then they will be separately compared with treatment as usual. Effect sizes and confidence intervals will be reported for each groupMplus [Sensitivity of the treatment effect estimates to potential biases arising from missing outcome data will be evaluated by the use of inverse probability weighting ,50. ThisMplus  again asA supplementary set of analyses will be undertaken to assess the effect of non-adherence to allocated treatment (again taking account of sensitivity to assumed missing data mechanisms) in order to estimate treatment effects in those patients who have complied with randomization . We have provided detailed examples of this approach elsewhere ,53.All analyses to estimate treatment effects will be variations on an analysis of covariance with the exact form depending on whether outcome is binary or quantitative. Covariates will include whether the patient is ambulatory or not, and whether the patient fulfils London ME criteria or not.Supplementary, exploratory analyses will be carried out to determine predictors of response to treatment. These will include, but may not be restricted to, (1) dichotomous variables such as membership of self-help group, whether ambulatory or not, whether the patient fulfilled London ME criteria, presence or absence of psychiatric diagnosis (e.g. depression); and (2) continuous variables such as illness duration, score on HAD depression scale, score on social support scale, and baseline illness beliefs scores. Analysis will take place once, after data collection is complete. There are no proposed interim analyses.The day to day management of the trial is carried out by Trial Manager, Dr Lisa Riste, in consultation with the Principal Investigator, Dr Alison Wearden, and other members of the trial team as necessary. A Trial Management Group consisting of the grant holders , the trial manager and research assistants meets monthly. Additional meetings are held to discuss aspects of the pragmatic rehabilitation and supportive listening therapies, as necessary. Monthly meetings to monitor trial recruitment are held. The trial is advised by an independent Trial Steering Committee and overseen by an independent Data Monitoring Ethics Committee, both of which meet yearly and operate in accordance with Medical Research Council Guidelines.Our trial will be the first randomised controlled trial of treatments for CFS/ME in primary care, and will add to the knowledge base in a number of ways. We have both a comparison treatment that controls for supportive therapist contact time and a treatment as usual control arm, which will help us to assess the efficacy of pragmatic rehabilitation. Our trial is conservatively powered, so we can be confident of detecting clinically significant effects. This is a pragmatic trial with relatively inclusive entry criteria, and we anticipate recruiting patients from across the spectrum of illness severity. Because we are treating patients in their homes, we are able to assess and treat patients who are unable to access secondary care services. These features will improve the generalisability of our findings.We have taken a number of steps to protect our trial against sources of bias. While therapist effects are not a primary outcome measure in this trial, we have chosen to use three nurses in order to minimise, or at least observe, possible therapist effects. To counteract possible biases introduced by the place of recruitment, all three nurses treat patients recruited from across the recruitment area. Differential willingness of patients to be randomised to treatment as usual is minimised by constraining only systematic psychological therapies for CFS/ME in the treatment as usual arm of the trial. To reduce observer bias in assessment, all assessment data are collected by research assistants not involved in, and blind to, treatment; in addition, the research assistants are accommodated in different locations from the therapists. All unblindings are recorded systematically. All outcome measures except the step-test are patient-rated. Bias and random error in handling data will be minimised by validation checks by the trial manager on data entry by the research assistants.If pragmatic rehabilitation is successful in producing a specific and lasting cost effective clinical benefit, we expect our findings to have a major impact on training and services in primary care. We will use our results to develop educational programmes for primary care health professionals. If our treatments prove effective and cost-effective in primary care, we envisage that they would be deliverable as specialist services provided or commissioned by primary care trusts. We have taken steps to ensure that our training of nurse therapists in the two treatments is well-described and replicable, so that training and service delivery can be implemented later.The author(s) declare that they have no competing interests.All authors contributed to the overall design of this study, and are involved in the ongoing management of the trial. AW is the principal investigator with overall responsibility for the FINE Trial. She conceived of the study, participated in its design and coordination, prepared the protocol, and participated in the training of nurse therapists. LR is the trial manager. She participated in staff training, is responsible for recruitment to the trial, staff management and coordination of the study. CD participated in the design and coordination of the study, the training of the nurse therapists, and the recruitment of general practices into the study. CCG is responsible for developing and overseeing the qualitative components of the trial, and assisting in the recruitment of general practices to the trial. RPB developed pragmatic rehabilitation treatment in secondary care, participated in the development of the supportive listening treatment, and participated in the training and ongoing supervision of nurse therapists. RKM participated in the training and ongoing supervision of nurse therapists, trained the researchers in psychiatric interviewing and operation of the inclusion and exclusion criteria, and contributed to the design of the qualitative study. SP is responsible for developing and overseeing the qualitative components of the trial, and assisting in the recruitment of patients to the trial. GD is the trial statistician. He advised on randomisation and all statistical aspects of the trial and developed the analysis plan. GR developed the health economic study and the health economics analysis plan. KL participated in the design of the therapy rating exercise and has advised on recruitment of patients into the trial. PP developed pragmatic rehabilitation treatment and the patient pragmatic rehabilitation manual in secondary care, participated in the training of the nurse therapists, and advised on the adaptation of pragmatic rehabilitation for the primary care setting. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:


Surveys of the public in a range of Western countries have shown a predominant belief in social stressors as causes of mental disorders. However, there has been little direct cross-cultural comparison. Here we report a comparison of public beliefs about the causes of mental disorders in Japan and Australia.Surveys of the public were carried out in each country using as similar a methodology as feasible. In both countries, household interviews were carried out concerning beliefs about causes and risk factors in relation to one of four case vignettes, describing either depression, depression with suicidal thoughts, early schizophrenia or chronic schizophrenia. In Japan, the survey involved 2000 adults aged between 20 and 69 from 25 regional sites spread across the country. In Australia, the survey involved a national sample of 3998 adults aged 18 years or over.In both countries, both social and personal vulnerability causes were commonly endorsed across all vignettes. The major differences in causal beliefs were that Australians were more likely to believe in infection, allergy and genetics, while Japanese were more likely to endorse "nervous person" and "weakness of character". For risk factors, Australians tended to believe that women, the young and the poor were more at risk of depression, but these were not seen as higher risk groups by Japanese.In both Japan and Australia, the public has a predominant belief in social causes and risk factors, with personal vulnerability factors also seen as important. However, there are also some major differences between the countries. The belief in weakness of character as a cause, which was stronger in Japan, is of particular concern because it may reduce the likelihood of seeking professional help and support from others. Mental health researchers view mental disorders as having complex causes involving an interplay of biological, psychological and social factors. However, the public's beliefs about causes are generally less sophisticated. Surveys of the public in a range of Western countries have shown a predominant belief in social stressors as causes of mental disorders. Studies from Australia, Ireland, Germany, Switzerland, UK and USA have found that social factors were most often seen as the causes of depression -6, whereOf greater concern is the stigmatizing belief that mental disorders are caused by personal weakness or a character flaw. While this is not a predominant belief, it is fairly common. In the USA, around one-third saw "own bad character" as a cause for both schizophrenia and depression , implyinWhile there has been considerable research on public beliefs in Western countries, there has been little research in other parts of the world and little cross-cultural comparison. The beliefs that predominate in Western countries cannot be assumed to apply elsewhere. A comparison of teachers' beliefs about schizophrenia in Japan and Taiwan found that "stress from personal relations" was commonly seen as a cause in both countries, which is similar to the belief in social factors in Western countries . HoweverHere we report a further cross-cultural comparison involving Japan and Australia. This comparison involved surveys in both countries using the same questions about causes and risk factors for four case vignettes: depression, depression with suicidal thoughts, early schizophrenia, and chronic schizophrenia. On the basis of previous research, it might be expected that a belief in social causes would predominate in both countries. However, there are a number of cultural and health system differences between the two countries that might influence responses. Japan places a greater emphasis on hospital care compared to the emphasis on community care in Australia. The Japanese mental health care system has been described as based on the values of minimizing state financial involvement, retaining family responsibility for family members, and social control of individuals who might contribute to social disorder . By contInterview questionnaires comprised a common core of questions that would allow comparisons between countries, and a country-specific component to allow investigation of issues particular to each country . Copies The only questions of relevance here are those concerned with causes and risk factors . These qThen followed questions about risk factors: "The next few questions seek your opinion about whether there are some people in the community who are more likely to have these problems and others who are perhaps less likely. Do you think that women would be more likely or less likely than men to suffer these sorts of problems? Would young people, under 25 years of age, be more likely or less likely? Would older people, those aged over 65, be more likely or less likely? Would poor people be more likely or less likely to suffer these sorts of problems? Unemployed people? Divorced or separated people? Would single people, who have never been married or in a long-term relationship be more likely or less likely?". The response options were: More likely, less likely, no difference, depends, don't know.A survey manual supplied from Australia was translated into Japanese and entrusted to Yamate Information Processing Center Ltd. for use with the target population aged 20–69 years, as a rule using the same procedures as Australia. The survey questionnaire, which was developed by the Australian researchers , was tentatively translated into Japanese. Then a native English translator, who had not seen the original English text, translated the Japanese version back into English. By comparing the two English versions, it was possible to confirm the accuracy of the original translation. There were no significant differences between the original text and the reverse translation. Finally, a Japanese version of the questionnaire was produced, which involved formatting the text into Japanese style and making slight wording adjustments. The names of the characters in the vignettes were translated into the Japanese style, viz. "A-o"(putting an o sound at the end is often used for a man's name) or "B-ko" (putting ko at the end is often used for a woman's name), instead of "John" or "Mary" which were used in the English text.As well as the questions taken from the Australian survey, the Japanese survey asked questions concerning such issues as psychiatric health and welfare policy, the bodies implementing related services, the existence of action groups, and the change in the Japanese name for schizophrenia by the Japanese Society of Psychiatry and Neurology. These additions were made to clarify the current Japanese situation and issues in related fields. Further, an original Japanese manual was also created and adopted for use concerning points of interest in the implementation of home visits.The survey method used was home visit interviews. It was not feasible to do a national survey of randomly selected households in Japan because of constraints of human resources, funding and time. It was therefore decided to sample a range of areas that differed in whether they were large or small cities, whether the area had many psychiatric patients or not, and whether the area had a high suicide rate or not. Using this approach, Japan was divided into 5 areas and 5 research sites were selected in each of these areas, giving a total of 25 geographic sites. As the survey was conducted during the winter, and because it was difficult to ensure that there would be enough survey interviewers, implementation in Hokkaido and Shikoku prefectures proved troublesome. Additional reasons for selection of the 25 regional sites were that they were places of comparatively high population within the relevant regions, the survey interviewers could use public transport, and the urban areas involved no particular inconveniences for the researchers to visit within a certain range using public transportation. 80 households were selected from each site, giving a total of 2000. At each site there were 4 interviewers who took responsibility for 20 households each. The survey was conducted over the period from 19 November to 12 December 2003. Each of the four vignettes was received by 250 people. Half received a male version of a vignette and half the female version.At the start of the survey, an explanatory meeting was held for the survey interviewers in each region. As many members of the research team as possible attended these explanatory meetings. Eighty-five survey interviewers were recruited for this research with an average age of 50 and an average of 17 years' experience of survey interviewing in various types of surveys. The areas for the survey interviewers to canvass were allocated on the basis of where they lived. The question of where the individual survey interviewers should go was determined mutually among the survey interviewers themselves, and by the head survey interviewer (supervisor). As a rule, one survey interviewer conducted 20 interviews, but this was considerably flexible, given the number of years of individual experience and what the individual survey interviewer could handle. The interviews were conducted according to the following procedure: visit the target's home and present the written greetings and request , then explain the details of the survey using the documents, ask the target for their participation in the research, start the interview and follow through to completion, check that nothing had been omitted from the survey responses, and hand over the remuneration (1000 yen cash voucher). Data were not collected on the refusal rate for this survey because the emphasis was on achieving the quotas of respondents to fit the required age and gender distribution.A household survey was carried out on Australian adults aged 18 years or over by the company AC Nielsen. Households were sampled from 250 census districts covering all states and territories and metropolitan and rural areas. Up to 5 call backs were made to metropolitan selections and 3 to non-metropolitan selections. Interviewers attempted to interview the person in each household with the most recent birthday. To achieve a target sample of 4,000 interviews with adults aged 18 years or over, visits were made to 28,947 households. The outcome of these visits was: no contact after repeated visits 14,630; vacant house or lot 306; refused 7,815; person sampled within household temporarily unavailable 1,132; no suitable respondent in household 287; did not speak English 383; incapable of responding 213; and unavailable for the duration of the survey 181. The achieved sample was 3998 persons, with 1001 receiving the depression vignette, 999 the depression with suicidal thoughts vignette, 997 the early schizophrenia vignette, and 1001 the chronic schizophrenia vignette. The interviews were carried out between November 2003 and February 2004.In addition to the common core component, the Australian survey interview had questions about awareness of depression in the media and about Australia's national depression initiative.Ethics approval was given by the Human Research Ethics Committee of the Australian National University.Data were pooled across male and female versions of each vignette and percent frequencies calculated. For the Japanese survey, percentage frequencies and 95% CIs were calculated using unweighted data with SPSS 12.0. For the Australian survey, percentages were calculated applying survey weights to give better population estimates. Ninety-five percent CIs were estimated using the Complex Samples procedure in SPSS 12.0. This procedure takes account of sampling weights and geographic clustering in the sample.Because of the very different cultures of Japan and Australia, it is possible that any differences in question endorsement rates might be due to subtleties of language or to the social rules applying to the interview situation, as well as to genuine differences in beliefs about treatment and outcome. For this reason, we have not relied on statistical significance of percentage differences between countries, but rather on the broad patterns of responses, particularly where percent endorsement was ordered very differently across questions.Table Comparing the Australian sample to the national population, there was an under-representation of males and of younger adults, but the sample was close to the population in marital status, country of birth and education. For the Australian sample, weights were used to correct for these biases.Table Tables The present findings from Japan and Australia support earlier work from several countries showing a predominant belief in social causes. These causes include day-to-day problems, death of someone close, traumatic events, and problems from childhood. The findings on risk factors are generally consistent with those on causes, with unemployment and divorce/separation widely seen to be risk factors in both countries. While a belief in social causes and risk factors was found in both countries, it was generally more common in Australia than in Japan. As far as depression is concerned, this belief is realistic because there is substantial evidence supporting social factors in the causation of depression . HoweverThe findings on poverty as a risk factor were an exception to the general trend of beliefs in social factors. While the Australians tended to see the poor as having higher risk, particularly for depression, for the Japanese the trend was in the opposite direction, with more people believing that the poor would have lower risk. The reason for this difference is unknown. It may reflect inaccurate beliefs in one country or else a true difference in risk factors between countries. In Australia, poverty is known to be associated with both depression and psychotic disorders ,17, althAs well as a frequent public belief about social causes in both countries, there was also a common belief in personal vulnerability factors. However, the endorsement of personal vulnerability factors tended to take a different form in each country. The Japanese were more likely to believe in the role of the trait characteristics of nervous person and weakness of character, while Australians were more likely to endorse the role of genetics. Being a nervous person could be regarded as a lay description of the personality trait of neuroticism, which is a major risk factor for depression. There is also some evidence that neuroticism is a risk factor for schizophrenia . HoweverThe strong endorsement of genetics by Australians represents a major change from 8 years earlier, from around half the population in 1995 to around two-thirds in 2003–04 . A possiAnother difference between the two countries was that Australians were more likely to believe in the role of virus or infection and allergy. It is not clear why these beliefs are more prominent in Australia. However, such beliefs appear to be stable over time, because the percentages endorsing these causes are very similar to an Australian national survey carried out 8 years earlier . These bTaking all the findings together, there is some broad similarity between public and professional beliefs about causation, in that mental disorders are seen to be influenced by a combination of personal vulnerability and environmental triggers. The major difference would appear to be the greater use of morally judgmental attributions of personal vulnerability by the public compared to the more objective attributions of professionals. In this regard, the Australian public's views appear closer to those of professionals than do the Japanese public's.We have previously discussed some of the limitations of this work . These rIn both Japan and Australia, the public have a predominant belief in social causes and risk factors for mental disorders. However, there are also some major differences between the countries, with Australians having a stronger belief in infections, allergies and genetics, while Japanese have a stronger belief in being a nervous person and weakness of character. The latter belief is of particular interest because is may be associated with greater stigma and reduce the likelihood of seeking professional help and support from others. Reducing the belief in weakness of character as a cause would be a suitable target for mental health literacy campaigns. This is probably easier to achieve for depression, where there are both contemporary and historical figures who have suffered from depression, yet are perceived as being strong in character.The author(s) declare that they have no competing interests.YN provided overall supervision of the research and provided comments on the manuscript.AFJ co-designed the Australian survey, analyzed the Australian data, and co-wrote the manuscript.YK provided specific guidance on the Japanese survey, including participation in survey interviewer training, and co-wrote the manuscript.HC co-designed the Australian survey and provided comments on the manuscript.HN provided specific guidance on the Japanese survey, including participation in survey interviewer training, and co-wrote the manuscript.KMG co-designed the Australian survey and provided comments on the manuscript.The pre-publication history for this paper can be accessed here:


Array CGH (Comparative Genomic Hybridisation) is a molecular cytogenetic technique for the genome wide detection of chromosomal imbalances. It is based on the co-hybridisation of differentially labelled test and reference DNA onto arrays of genomic BAC clones, cDNAs or oligonucleotides, and after correction for various intervening variables, loss or gain in the test DNA can be indicated from spots showing aberrant signal intensity ratios.Now that this technique is no longer confined to highly specialized laboratories and is entering the realm of clinical application, there is a need for a user-friendly software package that facilitates estimates of DNA dosage from raw signal intensities obtained by array CGH experiments, and which does not depend on a sophisticated computational environment.We have developed a user-friendly and versatile tool for the normalization, visualization, breakpoint detection and comparative analysis of array-CGH data. CGHPRO is a stand-alone JAVA application that guides the user through the whole process of data analysis. The import option for image analysis data covers several data formats, but users can also customize their own data formats. Several graphical representation tools assist in the selection of the appropriate normalization method. Intensity ratios of each clone can be plotted in a size-dependent manner along the chromosome ideograms. The interactive graphical interface offers the chance to explore the characteristics of each clone, such as the involvement of the clones sequence in segmental duplications. Circular Binary Segmentation and unsupervised Hidden Markov Model algorithms facilitate objective detection of chromosomal breakpoints. The storage of all essential data in a back-end database allows the simultaneously comparative analysis of different cases. The various display options facilitate also the definition of shortest regions of overlap and simplify the identification of odd clones.CGHPRO is a comprehensive and easy-to-use data analysis tool for array CGH. Since all of its features are available offline, CGHPRO may be especially suitable in situations where protection of sensitive patient data is an issue. It is distributed under GNU GPL licence and runs on Linux and Windows. DNA sequence copy number changes have shown to play an important role in the aetiology of cancer and congenital disorders. Comparative Genomic Hybridization (CGH) is a molecular cytogenetic method for the detection of chromosomal imbalances , which dHere we present a comprehensive data analysis software for array CGH. The program combines analysis and visualization of array CGH data. Furthermore it supports comparative analysis of complete study groups based on absolute and relative frequencies of aberrations.CGHPRO was programmed in Java and MySQL was used as the back-enddatabase. The decision to use Java and MySQL was based on their public availability, their platform independence and the fact that MySQL can handle large data files with high throughput. Two "R" packages from Bioconductor, DNAcopyTo date, CGHPRO allows the import of result files from GenepixPro5.0, Agilent and Imagene, but users can also customize the program to support their own data format. All essential data required to meet future standards of "minimal information about an array CGH experiment" can be stored in the database. Such standards have already been defined for gene expression analysis , but areThe genome annotation that has been integrated into the current version of CGHPRO is based on the UCSC Genome Browser , but useThe example chosen for demonstration of this software is a male versus female co-hybridization onto a 14000 BAC array, comprising a genome wide 1 Mb resolution BAC array  and theThe dataset for the comparative analysis was generated artificially.In CGHPRO a back-end database using MySQL has been implemented. The database stores the description of each analyzed chip (glass slide) as an entry in the table 'analyzedChips'. This description includes all essential information about the experimental and data analysis procedure, e.g. the number of spots that have been excluded and the normalization algorithm applied. A separate table named according to the Chip ID saves the original data from the image analysis software as well as the results from data analysis. A table called 'clonePosition' is used to store the mapping information for each clone. The information comprises data that might influence the reliability of the clone's hybridization characteristics, such as content of repetitive sequences and most importantly, its involvement in segmental duplications, which can be visualized by a colour code, as discussed below. In order to be able to use this feature properly, users with cDNA- or oligo-arrays have to adjust the chromosome positions of their probes. Instead of the actual chromosome position, one should define the chromosomal region, which the probe represents.CGHPRO allows the import of output files from several image analysis software packages, as listed above. Essential data are extracted and spots flagged as "poor" by the image analysis software are excluded automatically. Mapping information and related annotations for each clone are fetched from the back-end database.Mapping information for each clone, based on a specific version of UCSC Genome Browser, has to be provided by the user. For this purpose, a tab-delimited file has to be loaded into the back-end database, which must include six fields for each clone, the unique identifier, the respective chromosome, the positions of the first and last base pair, the source of the clone, and the user-specified comments of the clone. For the complete tiling path, as distributed by the BACPAC Resources Centre, the mapping information based on the April 2003 assembly of UCSC Genome Browser comes along with the software.The way this information is acquired differs from other recently published programs like ArrayCGHbase  or CAP , both ofCGHPRO provides a variety of graphical data representation tools to visualize the data before and after normalization. Scatterplots allow for estimates of the noise within a given data set. Spatial dependency of log ratios can be detected with Boxplots for all different subgrids. MAplots are implemented to detect intensity-dependent effects of the log ratios distribution , and theVisual inspection enables identification of clones that should be excluded from further analysis, and at the same time it provides a basis for choosing the appropriate method of normalization.The goal of normalization is to remove any systematic bias in the measured fluorescence intensities. Such systematic bias can originate from different labelling efficiencies of the used fluorochromes, different scanning parameters, spatial effects and/or other effects. In CGHPRO there are four options to remove these biases: Global Median, LOWESS  , SubgridIf one clone is spotted more than once on the chip, the replicate spots are automatically identified by their common ID. After normalization, the normalized ratios for the replicates are averaged and the standard deviations are calculated. This average ratio will later be used to represent the ratio of each clone. In subsequent analysis, users can set a threshold based on the number of replicas and standard deviation, such that clones exhibiting inconsistent results can be excluded.The eventual goal of array CGH is the characterization of the individual genomic profile. Up to now, the common method is to use fixed thresholds, which should be dependent on the variability of the data. CGHPRO allows users to set the threshold either directly, or smooth the data first and then set a threshold based on the smoothed results. For smoothing, CGHPRO provides two options. When using moving average, which is applied to each chromosome separately, a window of adjustable size moves along the clones, which are ordered according to their base pair positions on the chromosome. The smoothed ratio of the clone at a window's centre will be the average ratio of the clones within the window.The second smoothing strategy is to segment the clones, which are ordered along the chromosome, into sets with equal copy numbers. Then the data can be smoothed via averaging within the sets.CGHPRO includes two methods for the segmentation of chromosomes into regions with identical copy numbers, namely 'Unsupervised Hidden Markov Partition' created by Jane Fridlyand  and 'CirThe graphical interface of CGHPRO allows to explore the results in an interactive interface Figure . In the In each sub-panel, there are three lines along each chromosome. The yellow line represents a log ratio of zero; the individually adaptable green and red lines mark the negative and positive log ratios, respectively. The smoothed log ratios calculated by moving average, DNAcopy or aCGH can be chosen to be displayed as a black line called Smooth Line. Optionally, the original data can be blanked out.Each clone is colour-coded according to its involvement in segmental duplications, as defined by the following formula: (Σ Length of Duplication * Copy Number)/ Length of Clone. Based on the factors determined this way, the clones are grouped into seven classes that can be looked up separately by clicking on the button with the corresponding colour in the top right corner.Segmental duplications, which comprise ~5% of the human genome, are copies of genomic DNA with >90% sequence identity that range in size from 1 to >200 kb and are present in at least two locations in the human genome . MoreoveChromosome Display provides a detailed view of the selected chromosome Figure . In addiOnce stored in the database, all entries can be used for comparative analysis at the genomic, chromosomal and clone-by-clone level. Genomic View is especially suitable for the summarizing display of chromosomal aberrations in a series of cases. In this mode, the absolute frequencies of aberrations within a study group are displayed alongside the chromosome ideograms ordered in a 6 × 4 grid. Upon clicking on the chromosomes of interest in the list located at the left side of the screen, the program switches to the Chromosome View and zooms in the respective chromosome. In addition to the absolute frequencies of aberrations, the relative frequencies can also be shown, which makes it easier to compare study groups of different size Figure . For detAs in all other views, balanced regions are indicated in yellow, while deleted and gained regions are shown in red and green, respectively. The simultaneous display of results from several experiments can assist in the definition of shortest regions of overlap, can help to reveal patterns of chromosomal aberrations, and can facilitate the recognition of odd clones.CGHPRO represents a comprehensive and easy-to-use data analysis tool for array CGH. The software features the test of hybridization quality, normalization and visualization, as well as interactive data exploration and the comparative analysis of complete study groups. By providing all features offline, CGHPRO can be especially suitable in situations where protection of sensitive patient data is an issue. CGHPRO is written in Java and requires MySQL and R. The program runs on Linux and Windows operating systems.It is freely available for use under the terms of the GNU General Public Licences (GPL) at the project's homepage. The open design of CGHPRO allows the easy adaptation to specific needs and the future incorporation of new features.Project name: CGHPROProject home page: Operating system: Linux and Windows 2000Programming language: Java, SQL, ROther requirements: Java 1.4 or higher, MySQL database and RLicense: GNU General Public LicenseAny restriction to use by non-academics: Contact authorsWC was the principal programmer of the CGHPRO software. FE has performed the hybridization experiment and tested the program, HHR and SL contributed ideas for display and analyzing features and RU was responsible for defining the practical requirement catalog and contributed to manuscript preparation.


We describe an ongoing collaboration that developed as academic investigators responded to a specific request from community members to document health effects on black women of employment in poultry-processing plants in rural North Carolina. Primary outcomes of interest are upper extremity musculoskeletal disorders and function as well as quality of life. Because of concerns of community women and the history of poor labor relations, we decided to conduct this longitudinal study in a manner that did not require involvement of the employer. To provide more detailed insights into the effects of this type of employment, the epidemiologic analyses are supplemented by ethnographic interviews. The resulting approach requires community collaboration. Community-based staff, as paid members of the research team, manage the local project office, recruit and retain participants, conduct interviews, coordinate physical assessments, and participate in outreach. Other community members assisted in the design of the data collection tools and the recruitment of longitudinal study participants and took part in the ethnographic component of the study. This presentation provides an example of one model through which academic researchers and community members can work together productively under challenging circumstances. Notable accomplishments include the recruitment and retention of a cohort of low-income rural black women, often considered hard to reach in research studies. This community-based project includes a number of elements associated with community-based participatory research. Classic epidemiologic studies and historical research document that in the past, blacks in particular were openly selected for unpleasant, “dirty” jobs regarded as unsuitable for other workers . HistoriThe U.S. labor force continues to be segregated by race and gender . Blacks Inequities in rights to medical care and wage replacement under workers’ compensation are also present. Claim rejection for carpal tunnel syndrome has been reported to be strongly related to ethnicity and socioeconomic status, with claims by nonwhites, low-wage earners, and union members more likely to be challenged. Although more than 96% of the adjudicated cases in this report were eventually approved, the mean time involved in the process was over 1 year . In CanaThe Safety and Health of Working Women (SHOWW) project is a collaboration of academic researchers and community representatives in rural northeastern North Carolina designed to explore occupational roots of health disparities. Both the tradition of hiring the less advantaged in less desirable and often more dangerous jobs and the failure to acknowledge their occupational health concerns are at the core of this research. We present the conceptual framework for the project and describe the development of the collaboration as an example of one model through which academic investigators and community members can work effectively under challenging circumstances.In 1999 women working for a small nonprofit advocacy organization sought an academic partner to document health effects of employment on black women working in poultry-processing plants. Several of these women had experience with community and academic collaboration surrounding environmental health issues . Upper eThe study area, which includes five counties located in northeastern North Carolina, is poor and sparsely populated. Fifty-five percent of the five-county population is black, compared with 22% in North Carolina and 12% throughout the United States . This blThe development of the modern poultry industry and the economy of the rural South are closely connected. The production, processing, and marketing of poultry products have undergone a massive transformation. In 1960, 300 commercial suppliers and a larger number of family farms supplied chickens for the retail market. By 1990, fewer than 50 firms remained, and the top five among them supplied over a third of the market. Both production and processing of poultry are concentrated in the rural South .Modern poultry-processing plants are highly organized industrial structures for slaughter, disassembly, and packaging of birds . Rapid lThe poultry plants in our study area have a history of occupational health and safety problems. In 1989, N.C. Occupational Safety and Health Administration (OSHA) inspectors cited the two plants in the area for serious repetitive motion problems with some jobs documented to require over 10,000 repetitions per shift . After tMusculoskeletal disorders are a frequent reason for seeking medical care and common causes of chronic health problems and long-term disability . DespiteFrom this background, through discussions with the women who requested the research partnership, interviews with workers, and review of historical information on the poultry industry and the geographic area, we developed the conceptual framework illustrated in .Exposure refers to the external factors, or work requirements such as repetition, force, and postures, that produce the internal dose  on the worker. Dose refers to factors that disturb the individual mechanically, physiologically, or psychologically. Response includes the changes that occur in the individual in response to dose. Capacity, physical or psychological, refers to the ability of the individual to resist destabilization and is influenced by prior dose as well as other factors including health conditionsThe model posits that response at one level can affect dose at another level, and that the relationship between dose and response can be altered by previous dose. For example, repeated and prolonged exertions can result in desirable adaptation, as in a training effect on muscle or in undesirable reduced capacity, when a muscle is fatigued repeatedly without sufficient time to recover. Besides the direct effect of dose on tissue, the response of one tissue can affect another tissue. Connective tissue can thicken as it adapts to mechanical stress, and the thickening can lead to pressure on neural structures. Changes in upper-extremity function may represent pain and/or early tissue changes that, in turn, affect the individual’s capacity to withstand additional dose.In addition to the physical job requirements, worker capacity, skill, and the social and physical organization of the work environment may influence the development and/or expression of MSDs. Yet these relationships are highly complex and contextual . For exaWe also view perceptions and coping mechanisms as potentially significant modifiers of exposure and individual capacity. A worker with impaired upper extremity function who alters the manner in which she does the work changes her subsequent exposures. In a poultry plant, a woman’s assertive behaviors might alter physical exposures by securing job rotation or sharper tools; conversely, situations could arise where complicity might gain favor from superiors. Obviously, both job availability and assignment determine individual exposures. However, to emphasize the importance of context, the sphere in which the model sits represents the underlying industrial structure. Unstated policies, such as institutional racism, sexism, and classism, as well as stated ones, such as economic development plans, cannot be measured through a focus on individuals as independent actors. In seeking to understand contributions of work to health disparities, it is important to understand what happens in workplaces and how workers respond, but also how workplaces come to be in certain communities and what employment alternatives workers may or may not have.To address the concerns of women in the community and to improve cross-sectional investigations, we are conducting a longitudinal study of a volunteer cohort of women employed in poultry processing. Based on community concerns and the history of the industry’s poor labor relationships , we deciVolunteers participate in serial interviews and physical exams conducted at 3- to 6-month intervals over a maximum of 3 years. Community staff recruited participants over a 23-month period providing, by design, variable lengths of follow-up time and, consequently, variable cumulative occupational exposures. Although we initially limited recruitment to new hires to the industry, we later included longer-term employees to increase the overall efficiency of the study.We developed a multidimensional strategy of exposure assessment that will result in two streams of data for analyses: one based on group-level exposure assignment by department and job, and the second derived from individual-level self-report of exposure. The process began with in-depth, semistructured interviews with 37 workers from different departments and jobs. We are using the information from these workers, combined with general knowledge of the poultry-processing industry , to consIn addition, information from these key informant interviews guided the development of a self-report exposure assessment tool. The aggregated self-report data from women in the same jobs will be used in the JEM to help assign categories of exposure. The potential importance of individual behaviors, even in this assembly-line work, emerged in the analyses of the interview data. Long-term workers described behaviors that could potentially alter physical exposures, such as demanding sharper tools, taking unauthorized breaks, or refusing part of a job rotation or task. These are included in the assertiveness measure referenced in The final component of our research design involves the documentation of workers’ life histories through in-depth, ethnographic interviews that explore how their work affects their lives and how they make decisions about their employment. These interviews, separate from those conducted early in the project to inform the exposure assessment, are designed to provide a broader understanding of quality of life and a view of more dimensions of the poultry workers’ lives. We are interviewing women who have worked in the industry for variable periods of time, as well as some who are no longer employed in poultry processing. These interviews are typically conducted in several sessions (up to three) and over 1–3 years. We intentionally tried to find women who represented ranges of age, length of employment in the plant, satisfaction with work, and injury and disability, and who lived throughout the five-county study area. We relied on SHOWW community–based staff to recommend women to be interviewed. They suggested women they knew through social networks or kinship, as well as women who were enrolled in the longitudinal study, who seemed open and forthcoming during the staff-administered study questionnaire sessions. This was not intended to be a random sample; when using ethnographic interviews, the goal is to find people who are knowledgeable, representative of the population of interest, and willing to talk . Twenty-Our research design not only affords opportunities for, but requires, collaboration. Early in the project the community nonprofit agency that was our original partner was unable to meet the obligations of the research project. Since then, the project has not had an independent community partner, but rather community members who serve as paid staff at a project office located in the study area. With this arrangement the staff serving as community representatives are not agents of a community organization but work directly with the research team as university employees. Key elements of this collaboration and support provided to community staff are presented in The five members of the community-based team are all black women raised in northeastern North Carolina and range from 19 to 60 years of age. Although demographic similarities exist among the staff, their life and work experiences vary considerably; they bring diversity of expertise and skill to the study. All five women obtained a high school diploma; two continued on for an associate degree. Their collective work backgrounds include positions in poultry processing (nearly 30 years) and sewing factories (5 years); grocery stores (manager for 12 years and clerk for 1 year); nursing homes (2 years); beauty salons (3 years); and community-based service organizations (20 years). These women are our main connection to the community and actively participate in shaping the research.The community-based staff had no experience with a participatory or collaborative work-place. To augment their initial enthusiasm, to ensure that they would see themselves as integral to the project, and to foster equitable participation, we designed the project training using the elements of participatory learning . Key tenThese women work independently in an office 2.5 hr away from the university team, which gives them autonomy and responsibility. Community staff recruit participants and schedule their initial and follow-up interviews and examination appointments. They provide transportation, offer childcare and activities  for those who need to bring their children, and offer to conduct interviews in workers’ homes to facilitate participation. Data are collected through in-person interviews conducted by the staff using flip charts. Workers are able to view options to closed-ended questions as well as see visual cues, allowing participation by individuals who might otherwise have difficulty completing a lengthy questionnaire.In addition to identifying avenues for outreach in their community and attending various community events or meetings to discuss the project, the community staff provide valuable outreach to the academic community through participation in university classes in occupational epidemiology, community-driven research, and political science, providing important community perspectives to students and faculty.The academic project manager meets weekly with staff in the community. The meetings serve several purposes including information sharing, timely quality control of data, and problem solving. This regular forum promotes communication and allows dedicated time when input from staff is actively solicited and decisions can be made collectively.Although the academic team made the decision to conduct a longitudinal study, that decision was influenced by expressed concerns over the inability to document work-related disorders among community women, and the women agreed with the need for and logic of a longitudinal design. The community staff have remained routinely involved in design decisions. They influenced the decision to incorporate ethnographic methods by requesting ways in which interested workers with longer tenure in the plant or former workers could be involved. The community staff also felt that longer-term workers should have the opportunity to participate in the longitudinal study and that their involvement would facilitate recruitment of new hires to the industry.Input from current and former workers in the plants has also been critical in developing a self-report tool to capture personal exposure information. They provided information on potential sources of exposure variability that could be overlooked even in ergonomic assessments where investigators had access to the workplace. In addition, community members recruited participants and were compensated for this assistance at the suggestion of the staff.The community-based staff came to this work with no research experience and limited general office skills. To address these challenges, their training included questionnaire administration, recruitment strategies, and skill-building training to allow them to manage the community office . The staff continue to develop these skills. The academic researchers came to the project with different limitations. Many of us had little prior experience with this community and were naïve about the lives of women in this rural area 130 miles from our universities. Like our community partners, we continue to learn.Differences in communication, planning, and time management emphasized the cultural divide. Community-based staff correctly described the inability of participants to plan weeks or even days in advance for study appointments. This necessitated creating flexible office hours for exam times with study nurses. Even without the cultural differences between white academic researchers and black rural community members, the distance between the study site and institution limits daily interactions and makes the weekly meetings with the project manager an essential link.The protection of the privacy of research participants takes on added dimensions within the context of both occupational health and community-based research . The plaWe are asking workers to participate in a demanding protocol over several years. Both academic and community partners agreed that workers should be compensated for their time. Participants receive $40 for each data collection point involving an hour and a half interview and examination. Concern about effects of employment on health varies among participants, so compensation demonstrates respect for their time and their contribution to an effort for which they may not receive other direct benefits.Both the academic and community staff are affected by the difficult lives of the poultry workers. We are saddened when participants must immediately use their incentive to purchase food for their children or kerosene to heat their trailer. We are frustrated by the complexities of occupational health concerns, especially when participants choose not to seek medical care for fear of losing their jobs or being identified as patients. We do not know if these fears are justified, but workers perceive these as real possibilities and consequently they influence behaviors.The research process, including developing working relationships, building skills, recruiting workers, and maintaining their participation in this longitudinal study, has been time consuming. Recruitment, although designed to occur over time, has taken longer than initially planned. In economically depressed areas the immediate need for jobs can outweigh concerns about long-term health effects in the eyes of the community at large and in the eyes of workers. Low-wage industries such as poultry processing depend on a supply of unskilled labor; consequently, the industries have a vested interest in keeping economic growth low . AnxietySeverance of the original community subcontract occurred at a pivotal point shortly before we were to begin enrollment of women in the longitudinal component of the project. The community staff members, who had participated in the early exposure interviews with workers and months of training for their project roles, maintained their commitment to the project. They immediately focused on the logistics of the work, conducting regular staff meetings and the early baseline interviews with participants in their own homes and by finding space for the project office.There are significant rewards from our community-academic collaboration despite the challenges. The most notable achievement to date is the recruitment and retention of a cohort of 291 women, which would not have been possible without the community-based staff. Over 85% (87–97%) of those who were working at each follow-up period have remained in the study; 162 women (55.7%) remain in the cohort being followed. Data collection continues, with some participants having completed their seventh follow-up visit. Black women have not been adequately represented in epidemiologic studies, particularly studies related to occupational health, despite their high participation in the labor force and their higher-than-average levels of morbidity and mortality . ParticuLow-income black women are often labeled a “hard-to-reach” population by researchers . BarrierThe quality of data collection from our lengthy and complex questionnaire would not have been possible without in-person interviews. Our early analyses provide indicators of good face validity of the data. The musculoskeletal symptom reports are consistent with the hand-intensive nature of poultry-processing work and differ from those of other predominantly female occupational groups with different types of work exposures . The disUsing descriptions from the interviews with the early key informants, a series of Likert-scaled questionnaire items were developed for behaviors that we believe represent plant-specific assertiveness. The interview data allowed us to frame the items using the women’s own words such as, “How likely are you to tell your line leader to ‘back off’?” Using factor analytic techniques , we haveThe involvement of other community members in multiple facets of the study is conducive to outreach and community education. Formative work provided initial contacts with members of the community. While these women provided us with information about their work, we were able to provide them with information about the research effort. The same is true of women we interviewed for the life history portion of the study.Community-based participatory research (CBPR) encompasses a wide range of research methods, with varying levels of involvement from communities and researchers. Guidelines for this approach have been described for work with communities in general  and moreIn contrast to situations in which academic investigators seek to study a population defined by their own research interests, this collaboration developed as academic researchers responded to a request of women in rural North Carolina to document health effects of work in poultry processing, the largest employer in their area. As such, the project provides an example of truly community-driven research.The academic team viewed the request to some extent as a request for technical assistance. Early decisions about research design were made by the academic team based on input from women in the community, including the feasibility of the longitudinal design. Regardless of access, the fear and distrust of the industry among the worker community made the industry an unsuitable partner, and given this constraint, the research required community collaboration from the outset.Equitable participation and influence between researchers and community is another tenet of CBPR. We believe this is a lofty goal to strive for but also one difficult to measure and seldom realized . Our comResponsibility was central to the decision to break ties with the original community partner. However, the change altered power structures and the decision was not made lightly. We had a responsibility to the poultry workers to find a model in which we could conduct the work, and we also felt responsible to the community staff who had become our active partners. In the model under which we continue our project, the staff do not work under the umbrella of a community organization or labor union but rather as employees of the university. As such, they do not have a separate organization from which to draw power, which at least theoretically, would give them strength and independence within the project. However, the community-based staff were actively involved in this decision. They openly reported and quickly demonstrated empowerment from the break, and they believe the independent project office has provided added legitimacy and recognition.The restricted ability of many small community-based organizations to provide benefits of employment is often ignored in discussions of power and equity in community-based research. Health and life insurance, retirement contributions, and even paid vacation and sick leave are expected standards for university staff. The implications increase as the time committed by community staff to the project increases. In this project the community-based staff manage the project office, and their time commitments are greater than those of any other members of the academic team (30–35 hr per week). As university employees, they are eligible for corresponding benefits. These benefits, possible through our large university risk pool and the support afforded by substantial benefit rates on government grants, are often prohibitively expensive for small nonprofit and community organizations.One could argue that failure to acknowledge these issues and realistically evaluate what is gained by not working under the perceived power structure of a community agency contributes to the very disparities in health we seek to address in our collaborative research. Is it equitable for university researchers not only to enjoy but to expect these benefits, yet deny them to our community colleagues because it is not the community standard? In attempts to guarantee substantial community involvement and leveling of the playing field between community and academic teams, proscribing the proportions of funds that must be designated to community organizations in CBPR projects may not have the desired result as the research is operationalized. The issues are not easy ones to address, but they cut to very nature of this collaboration focused on the health of working women.We recognize that our project has both limitations and strengths. Occupational health research conducted without industry cooperation has merits and challenges. The volunteer cohort constitutes neither a full enumeration of potential workers nor a random sample of the population at risk. This will be a significant limitation of cross-sectional analyses of baseline findings in which subjects ideally would be selected based on exposure or disease. However, the longitudinal analyses focused on internal comparisons reduce the potential for bias. This does not negate the possibility of a healthy worker survivor effect , althougThe design we chose, which recruits and follows employed women, does not have an unexposed group. Unemployed women of working age may have characteristics that could confound results. They may belong to a different socioeconomic group, may not need to work, or may already have a work disability. Collecting detailed exposure assessment was not feasible for many work sites, so we focused our work only on women employed in poultry processing and made a conscious decision to trade external validity for improved internal validity.Lack of access to the workplace constrains our ability to observe and directly measure exposures. Instead, we are using a multidimensional, indirect approach to exposure assessment. Previous comparative studies have shown that this approach, using qualitative or semiquantitative exposure assessments by workers and health and safety professionals, can provide a valid ranking of exposure levels relative to quantitative measurements . In our Through the ethnographic life history interviews, women gave us insight into complex and subtle processes that may contribute to disparities in health. The women’s life stories revealed the effects that poorly funded schools, de facto segregation, teen childbearing, inadequate health care, cultural norms for work expectations, and a declining industrial base in the region may have on creating and maintaining disparities. Jointly, as academic researchers and representatives of the community, we intend to reach out to the community of poultry workers, the wider black and white communities, and academic, medical, and health policy circles. We have already found in sharing information from this project that the mix of quantitative epidemiologic data and qualitative ethnographic reports appeals to a wide variety of audiences.We present our project as an example of how one collaboration developed with the calculated tradeoffs in design and logistics as challenges were faced. The model for community collaboration is not the one originally planned, but we do believe it allowed a modicum of success to date that would not have been realized otherwise. Research projects evolve as they move from plans on paper to actual work. Community collaborations add another dimension that we believe requires substantial flexibility to allow each to be effective under unique and unpredictable circumstances. We are not proposing that our model is ideal but rather one through which we have worked effectively while more equitably sharing benefits and resources.In conclusion, in this research we focus on the physical environment of the workplace and the social environment, which includes the organization of work. However, it is important to see the workplace and the workers in the poultry plants as part of the larger economic and social environment. Working conditions—and occupational hazards—also vary by race and gender in ways that could affect worker health. Our research must be viewed within the broad context of economic realities of North Carolina, the United States, and the world. The migration of low-wage industry to economically disadvantaged areas of the rural South has led to the placement of poultry-processing plants in areas with a disproportionate share of women of color, many of whom are single heads of household with few economic alternatives.Because “the discovery of hazards and proposed remedies have the potential to adversely affect the profit margin of business , p 223,”