Formative research to design a culturally-appropriate cancer clinical trial education program to increase participation of African American and Latino communities.

BACKGROUND: Addressing knowledge deficiencies about cancer clinical trials and biospecimen donation can potentially improve participation among racial and ethnic minorities. This paper describes the formative research process used to design a culturally-appropriate cancer clinical trials education program for African American and Latino communities. We characterized community member feedback and its integration into the program. METHODS: We incorporated three engagement approaches into the formative research process to iteratively develop the program: including community-based organization (CBO) leaders as research team members, conducting focus groups and cognitive interviews with community members as reviewers/consultants, and interacting with two community advisory groups. An iterative-deductive approach was used to analyze focus group data. Qualitative data from advisory groups and community members were compiled and used to finalize the program. RESULTS: Focus group themes were: 1) Community Perspectives on Overall Presentation; 2) Community Opinions and Questions on the Content of the Presentation; 3) Culturally Specific Issues to Participation in Cancer Clinical Trials; 4) Barriers to Clinical Trial Participation; and 5) Perspectives of Community Health Educators. Feedback was documented during reviews by scientific experts and community members with suggestions to ensure cultural appropriateness using peripheral, evidential, linguistic, sociocultural strategies, and constituent-involving. The final program consisted of two versions (English and Spanish) of a culturally-appropriate slide presentation with speaker notes and videos representing community member and researcher testimonials. CONCLUSIONS: Incorporating multiple community engagement approaches into formative research processes can facilitate the inclusion of multiple community perspectives and enhance the cultural-appropriateness of the programs designed to promote cancer clinical trial participation among African Americans and Latinos.

[Citizens who volunteer as participants for cancer research-results of the Seintinelles Barometer 2018]. / Ces citoyen(nes) qui se portent volontaires pour participer aux recherches dans le champ du cancer ­ résultats du Baromètre Seintinelles 2018.

INTRODUCTION: Health researchers often face difficulties related to participants' recruitment for their research. However, a new strategy emerges: offering patients-but also citizens who are not ill-the possibility to volunteer as participants to hasten research processes. The French platform "Seintinelles" aims to fulfill this goal and bring together citizens who volunteered to participate to cancer related research. The "Seintinelles Barometer" aims to describe these volunteers' profile. METHODS: The Seintinelles Barometer data were collected through a web-based auto-questionnaire proposed to the "Seintinelles" members from June 2017 to November 2018. RESULTS: The sample presents a high level of overrepresentation of women. Participants are characterized by a high level of education. About a third of the participants had suffered from cancer. Two profile of volunteers emerged: the « patients ¼ and the « supportive citizens ¼. DISCUSSION: The Seintinelles Barometer participants manifest a strong wish to be involved in cancer related research. Therefore, this platform seems to be a promising tool for the development of community-based research in the field of cancer.

Children's views on taking medicines and participating in clinical trials.

INTRODUCTION: Limited information is available on the views of children taking medicines and participating in clinical trials. These views may contribute to a better understanding of what can be improved on in the development of medicines from their perspective. OBJECTIVE: To collect children's views on taking medicines and participating in clinical trials. MATERIALS AND METHODS: A question-based survey was conducted among children living in European Union countries between January and August 2015. RESULTS: Almost 900 children aged 10-17 years from Finland, Germany, Sweden, Spain and Hungary responded. Almost 40% had a chronic health condition. The most commonly used pharmaceutical forms were solid or liquid medicines for oral use and injectable medicines. Bad taste and pain during administration were reported as common problems. Of 785 respondents, 17% had been taking part in a clinical trial. Most respondents would potentially agree to take part in a clinical trial because the investigational medicine might improve their own health or that of other children. Concern that the investigational medicine might be harmful was the main reason to refuse participation, if asked to. Over half of the respondents were willing to learn more about clinical trials, preferably online. CONCLUSIONS: It is necessary to involve children in the development of age-appropriate pharmaceutical forms and in the design of clinical trials. Children and their carers should be provided with age-appropriate medical information in the most suitable channels. We have identified some common problems that children experience when taking medicines, and we conclude that children are interested in learning more and giving their opinions on clinical trials.

Participants' awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey.

BACKGROUND: The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics. METHODS: A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. RESULTS: A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P = ≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P = < 0.001). The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P = 0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively). CONCLUSION: Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.

Optimising informed consent for participants in a randomised controlled trial in rural Uganda: a comparative prospective cohort mixed-methods study.

BACKGROUND: Poor participant understanding of research information can be a problem in community interventional studies with rural African women, whose levels of illiteracy are high. This study aimed to improve the informed consent process for women living in rural eastern Uganda. We assessed the impact of alternative consent models on participants' understanding of clinical trial information and their contribution to the informed consent process in rural Uganda. METHODS: The study applied a parallel mixed-methods design for a prospective comparative cohort, nested within a pilot study on the community distribution of an alcohol-based hand rub to prevent neonatal sepsis (BabyGel pilot trial). Women of at least 34 weeks' pregnancy, suitable for inclusion in the BabyGel pilot trial, were recruited into this study from their homes in 13 villages in Mbale District. As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information, a slide show using illustrated text on a flip chart or a video showing the patient information being read as if by a newsreader in either English or the local language. In addition, all women received the patient information sheet in their preferred language. Each information-giving method was used in recruitment for 1 week. Two days after recruitment, women's understanding of the clinical trial was evaluated using the modified Quality of Informed Consent (QuIC) tool. They were also shown the other two methods and their preference assessed using a 5-point Likert scale. Semi-structured interviews were administered to each participant. The interviews were audio-recorded, transcribed and translated verbatim, and thematically analysed. RESULTS: A total of 30 pregnant women in their homes participated in this study. Their recall of the trial information within the planned 48 h was assessed for the majority (90%, 27/30). For all three consent models, women demonstrated a high understanding of the study. There was no statistically significant difference between the slide-show message (mean 4.7; standard deviation, SD 0.47; range 4-5), video message (mean 4.9; SD 0.33; range 4-5) and standard method (mean 4.5; SD 0.53; range 4-5; all one-way ANOVA, p = 0.190). The slide-show message resulted in the most objective understanding of question items with the highest average QuIC score of 100 points. For women who had been recruited using any of the three models, the slide show was the most popular method, with a mean score for all items of not less than 4.2 (mean 4.8; SD 0.6; range 4-5). Most women (63%, 19/30) preferred the slide-show message, compared with 17% (5/30) and 20% (6/30) for the standard and video messages, respectively. The reasons given included the benefits of having pictures to aid understanding and the logical progression of the information. CONCLUSION: Our results from this small study suggest that slide-show messages may be an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom have little or no literacy. TRIAL REGISTRATION: ISRCTN, ISRCTN67852437 . Registered on 18 March 2018.

The interaction of personal, contextual, and study characteristics and their effect on recruitment and participation of pregnant women in research: a qualitative study in Lebanon.

BACKGROUND: Declining participation rates are impeding health research. Little is known about factors influencing the decision to participate in low- and middle-income countries (LMIC). Therefore, this paper reports on the various individual factors and their with contextual factors in influencing participation in research among pregnant women and the recommendations to enhance their recruitment in Lebanon. METHODS: This study used a qualitative research design drawing on focus groups and in-depth interviews. The Theoretical Domain Framework guided data collection and analysis. The three participant groups included: Group 1-Pregnant women (n = 25) attending public pre-natal events and antenatal clinics in Beirut; Group 2-Pregnant women (n = 6) already enrolled in the ongoing Mother and Infant Nutritional Assessment birth cohort study; Group 3-Key informants (n = 13) including health care workers involved in recruiting pregnant women. Conversations were audio recorded, transcribed, translated into English, and thematically analyzed. RESULTS: Three main factors influencing participation were revealed, with each factor encompassing several sub-themes: (1) personal factors (altruism, self-confidence, personal interest in the topic, previous understanding of the nature and purpose of research, education level, and previous research experience), (2) contextual factors (societal factors, family and friends), and (3) study characteristics (burden of the study, ethical considerations, incentives, and research interpersonal skills and physician endorsement to participate). The results suggested a dynamic interaction among the identified factors, forming two intersecting axes, with a four-quadrant configuration. The y- and x-axes represented personal factors and contextual factors, respectively. Individuals positioned on the lower-left quadrant were the least likely to participate; those on the upper-right quadrant were the most likely to participate; while those on the upper-left and lower-right quadrants were indecisive. Study characteristics seemed to affect the decision of pregnant women to participate situated in any of the four quadrants. Specific recommendations to improve participation were also identified. CONCLUSIONS: Our findings suggested an interaction of personal factors, contextual factors, and study characteristics affecting subjects' participation. This interaction integrates factors into a novel dynamic framework that could be used in future studies. The recommendations identified may help improve participation of pregnant women in health research hence enhancing the quality and generalizability of research findings in LMIC.

"I didn't have anything to decide, I wanted to help my kids"-An interview-based study of consent procedures for sampling human biological material for genetic research in rural Pakistan.

BACKGROUND: Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures, complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with the values underlying informed consent. METHODS: Over a 2-week period in April 2014 we conducted semistructured interviews with researchers from a genetic research institute in rural Pakistan and families who had given blood samples for their research. Interviews with researchers focused on the institute's requirements for consent, and the researchers' strategies for and experiences with obtaining consent in the field. Interviews with donors focused on their motivation for donating samples, their experience of consent and donation, and what factors were central in their decisions to give consent. RESULTS: Researchers often reported modifications to consent procedures suited to the local context, standardly employing oral and elder consent, and tailoring information to the social education level of donor families. Central themes in donors' accounts of their decision to consent were the hope of getting something out of their participation and their remarkably high levels of trust in the researchers. Several donor accounts indicated a degree of confusion about participation and diagnosis, resulting in misconceived expectations of therapeutic benefits. CONCLUSIONS: We argue that while building and maintaining trusting relationships in research is important-not least in developing countries-strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out.

Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials.

BACKGROUND: Randomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias. However, recruitment and subsequent retention of children and adolescents in healthcare trials is challenging. Participant information sheets are often lengthy and difficult to read and understand. Presenting key information using multimedia may help to overcome these limitations and better support young people and their parents in deciding whether to participate in a clinical trial. METHODS: The TRECA (TRials Engagement in Children and Adolescents) study has two phases. The first phase involves a qualitative study with children and adolescents and their parents to inform the development of multimedia information resources and iterative user testing to refine the resources. The second phase will embed the use of the multimedia information resources into six host trials in the United Kingdom. Patients and parents approached to participate in the host trials will be randomly allocated to either use the multimedia information resource in conjunction with standard participant information sheets, the multimedia information resource alone, or the standard participant information sheets alone. The primary outcome will be the effect of the multimedia information resources on recruitment into trials. Other outcomes measured include the effect of multimedia information resources on retention of participants into the host trials and the impact on family members' decision-making processes, when compared to standard participant information sheets alone. DISCUSSION: This study will inform whether multimedia information resources, when developed using participatory design principles, are able to increase recruitment and retention of children and adolescents into trials. There is also the potential for patients to make better informed decisions through the use of multimedia information resources. The multimedia information resources also have the potential to assist with providing information on other healthcare decisions outside of clinical trials. TRIAL REGISTRATION: ISRCTN registry: ISRCTN73136092 (doi: 10.1186/ISRCTN73136092 ). Registered on 24 August 2016.

Poor uptake of an online intervention in a cluster randomised controlled trial of online diabetes education for rural general practitioners.

BACKGROUND: In Australia, rural and remote communities have high rates of diabetes-related death and hospitalisation. General practitioners (GPs) play a major role in diabetes detection and management. Education of GPs could optimise diabetes management and improve patient outcomes at a population level. The study aimed to describe the uptake of a continuing medical education intervention for rural GPs and its impact on the viability of a cluster randomised controlled trial of the effects of continuing medical education on whole-town diabetes monitoring and control. METHOD: Trial design: the cluster randomised controlled trial involved towns as the unit of allocation and analysis with outcomes assessed by de-identified pathology data (not reported here). The intervention programme consisted of an online active learning module, direct electronic access to specialist advice and performance feedback. Multiple rounds of invitation were used to engage GPs with the online intervention content. Evidence-based strategies (e.g. pre-notification, rewards, incentives) were incorporated into the invitations to enrol in the programme. Recruitment to the programme was electronically monitored through the hosting software package during the study intervention period. RESULTS: Eleven matched pairs of towns were included in the study. There were 146 GPs in the 11 intervention towns, of whom 34 (23.3%) enrolled in the programme, and 8 (5.5%) completed the online learning module. No town had more than 10% of the resident GPs complete the learning module. There were no contacts made by GPs regarding requests for specialist advice. Consequently, the trial was discontinued. CONCLUSION: There is an ongoing need to engage primary care physicians in improving diabetes monitoring and management in rural areas. Online training options, while notionally attractive and accessible, are not likely to have high levels of uptake, even when evidence-based recruitment strategies are implemented. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, identifier: ACTRN12611000553976 . Retrospectively registered on 31 May 2011.

A systematic review of training programmes for recruiters to randomised controlled trials.

BACKGROUND: Recruitment to randomised controlled trials (RCTs) is often difficult. Clinician related factors have been implicated as important reasons for low rates of recruitment. Clinicians (doctors and other health professionals) can experience discomfort with some underlying principles of RCTs and experience difficulties in conveying them positively to potential trial participants. Recruiter training has been suggested to address identified problems but a synthesis of this research is lacking. The aim of our study was to systematically review the available evidence on training interventions for recruiters to randomised trials. METHODS: Studies that evaluated training programmes for trial recruiters were included. Those that provided only general communication training not linked to RCT recruitment were excluded. Data extraction and quality assessment were completed by two reviewers independently, with a third author where necessary. RESULTS: Seventeen studies of 9615 potentially eligible titles and abstracts were included in the review: three randomised controlled studies, two non-randomised controlled studies, nine uncontrolled pre-test/post-test studies, two qualitative studies, and a post-training questionnaire survey. Most studies were of moderate or weak quality. Training programmes were mostly set within cancer trials, and usually consisted of workshops with a mix of health professionals over one or two consecutive days covering generic and trial specific issues. Recruiter training programmes were well received and some increased recruiters' self-confidence in communicating key RCT concepts to patients. There was, however, little evidence that this training increased actual recruitment rates or patient understanding, satisfaction, or levels of informed consent. CONCLUSIONS: There is a need to develop recruiter training programmes that can lead to improved recruitment and informed consent in randomised trials.

A little more conversation please? Qualitative study of researchers' and patients' interview accounts of training for patient and public involvement in clinical trials.

BACKGROUND: Training in patient and public involvement (PPI) is recommended, yet little is known about what training is needed. We explored researchers' and PPI contributors' accounts of PPI activity and training to inform the design of PPI training for both parties. METHODS: We used semi-structured qualitative interviews with researchers (chief investigators and trial managers) and PPI contributors, accessed through a cohort of clinical trials, which had been funded between 2006 and 2010. An analysis of transcripts of audio-recorded interviews drew on the constant comparative method. RESULTS: We interviewed 31 researchers and 17 PPI contributors from 28 trials. Most researchers could see some value in PPI training for researchers, although just under half had received such training themselves, and some had concerns about the purpose and evidence base for PPI training. PPI contributors were evenly split in their perceptions of whether researchers needed training in PPI. Few PPI contributors had themselves received training for their roles. Many informants across all groups felt that training PPI contributors was unnecessary because they already possessed the skills needed. Informants were also concerned that training would professionalise PPI contributors, limiting their ability to provide an authentic patient perspective. However, informants welcomed informal induction 'conversations' to help contributors understand their roles and support them in voicing their opinions. Informants believed that PPI contributors should be confident, motivated, intelligent, focussed on helping others and have relevant experience. Researchers looked for these qualities when selecting contributors, and spoke of how finding 'the right' contributor was more important than accessing 'the right' training. CONCLUSIONS: While informants were broadly receptive to PPI training for researchers, they expressed considerable reluctance to training PPI contributors. Providers of training will need to address these reservations. Our findings point to the importance of reconsidering how training is conceptualised, designed and promoted and of providing flexible, learning opportunities in ways that flow from researchers' and contributors' needs and preferences. We also identify some areas of training content and the need for further consideration to be given to the selection of PPI contributors and models for implementing PPI to ensure clinical trials benefit from a diversity of patient perspectives.

Effect of training on the reliability of satiety evaluation and use of trained panellists to determine the satiety effect of dietary fibre: a randomised controlled trial.

BACKGROUND: The assessment of satiety effects on foods is commonly performed by untrained volunteers marking their perceived hunger or fullness on line scales, marked with pre-set descriptors. The lack of reproducibility of satiety measurement using this approach however results in the tool being unable to distinguish between foods that have small, but possibly important, differences in their satiety effects. An alternate approach is used in sensory evaluation; panellists can be trained in the correct use of the assessment line-scale and brought to consensus on the meanings of descriptors used for food quality attributes to improve the panel reliability. The effect of training on the reliability of a satiety panel has not previously been reported. METHOD: In a randomised controlled parallel intervention, the effect of training in the correct use of a satiety labelled magnitude scale (LMS) was assessed versus no-training. The test-retest precision and reliability of two hour postprandial satiety evaluation after consumption of a standard breakfast was compared. The trained panel then compared the satiety effect of two breakfast meals containing either a viscous or a non-viscous dietary fibre in a crossover trial. RESULTS: A subgroup of the 23 panellists (n = 5) improved their test re-test precision after training. Panel satiety area under the curve, "after the training" intervention was significantly different to "before training" (p < 0.001). Reliability of the panel determined by intraclass correlation (ICC) of test and retest showed improved strength of the correlation from 0.70 pre-intervention to 0.95 post intervention. The trained "satiety expert panel" determined that a standard breakfast with 5g of viscous fibre gave significantly higher satiety than with 5g non-viscous fibre (area under curve (AUC) of 478.2, 334.4 respectively) (p ≤ 0.002). CONCLUSION: Training reduced between panellist variability. The improved strength of test-retest ICC as a result of the training intervention suggests that training satiety panellists can improve the discriminating power of satiety evaluation.

[Development of patient education materials for the "German Prostate Cancer Trial PREFERE"]. / Entwicklung von Aufklärungsmaterialien für die "Deutsche Prostatakrebsstudie PREFERE".

The German prostate cancer study PREFERE (www.prefere.de) started in January 2014. It is the first randomised controlled and preference-based trial to investigate all four options available for the treatment of organ-confined prostate cancer. According to the "Interdisciplinary evidence-based S3 guideline for the early detection, diagnosis and treatment of the different stages of prostate cancer" [1], these options include: radical prostatectomy, external radiotherapy, brachytherapy and active surveillance. In the context of PREFERE preference-based means that potential study participants who do not agree to being randomised into all four treatment arms can maximally refuse two treatment arms. This poses a big challenge to the patient education strategy employed and the information material it requires. In order to inform patients in the context of the PREFERE trial patient education materials (patient leaflet and video) had to be designed that provide patients with balanced and guideline-based information about the disease and the treatment options available, about the need for randomisation and, in particular, about the PREFERE trial and support their individual preference finding and shared decision making for participating in the trial. An iterative structured approach was used to develop the information materials on the basis of a previous literature search. Six focus groups with a total of 40 participants from three different self-help groups, affected men that do not belong to a self-help group, healthy men as well as experts, the members of the steering committee of the PREFERE trial and a focus group consisting of 18 male and female urologists were involved in the development and testing of both the patient information leaflet and the patient video. Both the patient information leaflet and the video supporting preference finding and decision making for participating in the PREFERE trial were tested for understandability and suitability by using a questionnaire and conducting a comprehensive discussion. The results of these lay evaluations have been included in the final revision. Also, a communication resource for physicians has been created comprising all the essential aspects of the PREFERE patient education materials. A short course conducted all over Germany will focus on the process of patient teaching as well as patient education materials. Whether and to what extent the decision for participating in the PREFERE trial has actually been influenced 1) by what the treating physicians communicated to the patient and 2) by the patient education materials used is one of the subjects of a quality of life survey that will be conducted following treatment or - in the case of the active surveillance option - after randomisation during the PREFERE trial.

A leitura das LER/DORT pelos trabalhadores da trefilaria de São Paulo da siderurgia belgo mineira / Reading the LER/DORT by drawing mill workers of São Paulo mining Belgian steel

As lesões musculoligamentares relacionadas ao trabalho, inicialmente, chamadas de LER (Lesões por Esforços Repetitivos) e, posteriormente, de DORT (Distúrbios Osteomusculares Relacionados ao Trabalho), são consideradas, talvez, a patologia ocupacional de maior controvérsia pelo modo de adoecer. Acometem principalmente a população jovem, no auge de sua produtividade e existência. No final da década de 80, começaram a surgir as epidemias de LER / DORT no Brasil e no mundo, tornando-se grave e preocupante problema de saúde pública, devido aos custos socioeconômicos elevadíssimos. Dentre os fatores causadores das LER / DORT, estão aspectos de administração, organização e ergonômicos do Trabalho. Esta dissertação tem como objetivo principal entender o que os trabalhadores da Trefilaria de São Paulo da Siderurgia Belgo Mineira pensam sobre as LER / DORT. Para tanto, aplicou-se a metodologia qualiquantitativa, utilizando-se o Discurso do Sujeito Coletivo, característica própria e indissociável do pensamento coletivo, considerado e preservado em todos os momentos da pesquisa, desde a elaboração das perguntas, coleta e processamento dos dados, até a apresentação dos resultados. Concluiu-se pela análise ter havido evolução do entendimento do que sejam as LER / DORT, bem como a forma de prevenção e tratamento quando comparadas às representações dos trabalhadores no final da década de 80. (AU)

Work-related injuries to muscle tissue and ligaments, initially denominated “Injuries caused by Repetitive Strain Injury (RSI)” and later on “Work Related Musculoskeletal Disorders (WMSD)”, are probably the most controversial occupational pathology today, due to the way in which they are contracted. The victims are mostly young people at the peak of their productive professional existence. In Brazil and around the world “RSI/WMSD” began to reach epidemic proportions in the late eighties, becoming a serious public health problem due to its extremely high social and economic costs. Certain aspects of administration, organization, and ergonomics at the workplace, among others, are increasingly perceived as the reasons for the emergence of “RSI/WMSD”. The object of this dissertation was to find out and understand what the workers of Siderurgia Belgo-Mineira’s Trefilaria de São Paulo think about “RSI/WMSD”. To this end was applied the method of quality and quantity evaluation by using “Expressions of the Collective Subject”. This, being an inseparable characteristic of collective thinking, has been the guideline throughout the research, from collecting and processing data to the final conclusion of this work. Analyzing the findings, the conclusion is that there has been significant advance, as far as the understanding of “RSI/WMSD”, its prevention and treatment are concerned, compared with workers’ perception of the problem in the late 80s. (AU)