Access to health services is a particular challenge for First Nations  communities living in remote or underserviced areas. Teleophthalmology can provide them with the same level of retinal screening services provided to those in urban centers. This screening can lead to the identification of high-risk individuals who can then be monitored and receive treatment related to their diabetes or other health issues.The intent was to develop, implement, and evaluate a service delivery model for teleophthalmology screening and follow-up for at-risk and diabetic First Nations clients on Vancouver Island, British Columbia, Canada.A highly consultative, culturally appropriate, and collaborative approach was used to develop and deploy a teleophthalmology service delivery model to First Nations communities. This project was evaluated with regard to utilization and operational costs. Also, clinicians and team members involved in the teleophthalmology project provided assessments of the teleopthalmology quality, productivity, and access. Health providers in First Nations communities provided their perceptions of areas of improvement for the remote retinal screening services, areas where expansion of services could be offered, and opportunities to increase client education and health promotion.All 51 First Nations communities on Vancouver Island expressed interest in receiving teleopthalmology services. During the 1-year project, teleopthalmology clinics were held in 43 of 51 communities on Vancouver Island. During these clinics, 524 clients were screened and 140 of those clients were referred to a general ophthalmologist, family doctor, retinal specialist, optometrist, or other provider. Ratings of teleopthalmology system quality, information quality, service quality, and system usage were positive. Satisfaction with the teleopthalmology project was high among clinicians involved with the project. Satisfaction was also high among health providers in First Nations communities, with clinic scheduling identified as a potential area of improvement moving forward. The average cost savings per client, taking project costs into consideration, was calculated to be CAN $28.16, which was largely due to the elimination of client travel costs.Teleophthalmology was a welcome addition to health services by the First Nations communities on Vancouver Island, as evidenced by the 100% rate of interest from those communities. There was no evidence of dissatisfaction by clinicians involved in the teleopthalmology project or by First Nations community health providers. The now-operational teleopthalmology program is a testament to the early success of the project. Aboriginal peoples living in Canada are among the highest risk populations for diabetes and related complications .For First Nations communities, which are most often remote and geographically isolated, availability of primary health care is often reduced, and access to secondary and tertiary care can be challenging or non-existent. This includes access to eye-related services such as ophthalmology and optometry, which are important for at-risk and diabetic individuals.Teleophthalmology enables remote populations to access retinal screening services provided more readily in urban centers. This screening can lead to the identification of high-risk individuals who can then be monitored and receive treatment related to their diabetes or other health issues.Mobile screening initiatives for First Nations and aboriginal populations have previously been conducted and evaluated in Canada. A retinopathy remote screening pilot project among Quebec First Nations populations found positive outcomes with respect to satisfaction among community members and users, and financial and societal costs . In AlbeThe teleopthalmology project began in November 2008 and was officially launched on May 14, 2010. The project was led by the Inter Tribal Health Authority (ITHA) in British Columbia (BC), in collaboration with the Vancouver Island Health Authority (VIHA). The project concluded in July 2011, at which time it became and still remains an operational program.The objectives of the teleophthalmology project were to develop and implement an effective teleophthalmology service model, which included an accessible and integrated mobile retinal screening and tracking service. This teleophthalmology service model would be implemented for high-risk populations  in rural and remote populations at risk of retinopathies. A target of 600 people at risk of retinopathy was set for screening. It was anticipated that the service model developed and used for the teleophthalmology project would provide a basis for a broader provincial program. The project focused on retinal health and eye disease, and was not intended to replace routine visits to optometrists. In fact, referrals resulting from teleophthalmology visits would include referrals to optometrists.The Canada Health Infoway Benefits Evaluation Framework  providesMatters of communication and community engagement were particularly critical to ensure awareness of vision-related disease among diabetics in First Nations communities and acceptance of the teleophthalmology project. Adherence to, and respect of, First Nations’ cultural values were considered to be the most important aspects and success factors of the project.The first 5 months of the project were dedicated to implementing a community engagement strategy. The teleopthalmology project team sent letters to all 51 First Nations communities on Vancouver Island to determine the communities’ interest in a short presentation about the project.The communities were invited to attend project launch meetings. Representatives from all communities attended these meetings, which served as informational sessions that invited participation in the teleopthalmology project. Attendees included chiefs, band members, community nurses, and representatives from both VIHA and ITHA. These meetings adhered to cultural protocols, and were widely publicized by the media, sponsors, and ITHA. Key messages pertained to awareness about the project, the importance of retinal screening, and implications for those suffering from diabetes.After the meetings, representatives from First Nations communities that were interested in participating in the project were welcome to contact the teleophthalmology project team. Clinic dates and times for communities were determined based on the communities’ availability and preferences.As well, a letter of intent was also sent to the British Columbia Association of Optometrists to its members of the teleophthalmology project. This letter provided details about the project, and also explained that the project was not intended to replace optometrist visits or discourage clients from making routine visits with optometrists.The Inter Tribal Health Authority was responsible for overall management and direction of the project. Various ITHA team members developed materials, put together the community engagement strategy, developed and delivered communications with stakeholders, and addressed logistical and technical matters. A Telehealth Project Office was instituted within ITHA, and the provincial Telehealth officer oversaw the project.A medical advisor and clinical advisory group were put in place for this project. They provided medical expertise, community engagement advisement, and acted as a sounding board to ensure that the project operated in a culturally appropriate manner with the First Nations communities. The clinical advisory group consisted of administrators, ophthalmologists, First Nations leaders, various health care providers, ITHA leaders, and teleophthalmology project team members. One key representative from each of the three language groups across Vancouver Island was invited to join the clinical advisory group to guide and protect their interests and convey information to and for their communities.Potential clients were initially identified through a combination of activities and information sources, and in cooperation with the existing chronic disease management (CDM) program and health services providers. The participating First Nations communities provided ITHA with lists of individuals in their communities who were diabetic, individuals previously diagnosed and treated for type 1 or type 2 diabetes, individuals at risk of diabetes, or individuals with a family history of diabetes.These individuals received phone calls from the ITHA team to schedule individual screening appointments during clinics to be held in their communities. Other individuals also learned about upcoming clinics in their communities through local health care providers and by word of mouth. The clinical advisory group recommended that an open door policy exist for the screening clinics, and individuals who self-referred to the clinics also received services.The teleophthalmology project involved the implementation of a service delivery model, including the technology to deliver services. The service delivery model arose from a detailed workflow analysis directed by the clinical advisory group and the medical advisor.A comprehensive clinical procedure and protocol manual was developed by ITHA to define and standardize how the mobile teleophthalmology clinics would be conducted. It identified all processes, materials and equipment, and roles involved. The manual included the teleophthalmology service delivery model.This teleopthalmology service delivery model provided early retinopathy detection services to residents of rural and remote communities, and utilized a proven pathway for effective treatment of retinopathy that can reduce incidence, as well as social and economic impacts, of blindness and vision impairment .The service delivery model provided the following set of services: retinal screening, triage, treatment, and tracking. A description of the activities and workflow are discussed below; following that is a description of the technology and equipment.A team of two First Nations technicians and a trained teleopthalmology eye care nurse travelled to the remote First Nations communities within the geographic region of the VIHA. They travelled in a truck that was dedicated to the teleopthalmology project; the truck was fully outfitted with the equipment required to hold the clinics.Wherever possible, clinics were held within existing health centers in the communities. In some cases, they were held in community centers or gymnasiums, with provisions made for client privacy during appointments. Clinics typically operated from 8am until 4pm, varying based on travel schedule and client volume.The nurse registered individuals upon their arrival to the clinics. In the waiting area, clients were given pamphlets that explained the importance of the teleopthalmology project. They were also given small MP3 players with which to listen to diabetes education content while awaiting their appointments.The clients were then assessed for details of visual function, intraocular pressure, and three-dimensional digital photographs of the anterior and posterior segments of the eye. Alcaine drops were used for freezing prior to intraocular pressure testing and Tropicamide drops were used for dilation. Pilocarpine drops were kept in case of a close angle glaucoma reaction. Drops were administered by the nurse. Client data collected for registration and screening included: demographics, an abbreviated medical history, tonometry, and visual acuity results.The technicians securely uploaded images to the ITHA Data Centre for subsequent assessment by either an ophthalmologist in Comox, BC or a retinal specialist in Victoria, BC. Their documentation and reports included recommendations for follow-up examinations or specific additional tertiary examination and treatment. Follow-up communications and appointments proceeded based on the grading assessments and results. The teleopthalmology project at ITHA effectively operated as a satellite office for the ophthalmologist and retinal specialist by scheduling follow-up appointments with other eye specialists on Vancouver Island based on the type of referrals made during the grading of the retinal images.All clients were contacted after their appointments regardless of the outcomes of their assessments. They were mailed a copy of the teleophthalmology report unless mailing addresses were unknown. In those cases, reports were sent via fax to the clients’ local community health units. The clients’ physicians also received a copy via mail.ITHA produced a weekly summary for the clinical advisory group. It combined the standard reports used by the teleopthalmology project team .Mobile units contained program equipment and disposable clinic supplies. These included a retinal camera, peripheral devices, laptop, image capture software, and travel containers.The camera was a Topcon NW6-S Retinal Camera, which weighed 89 lb including the case. A truck lift was required for the vehicle, and a two-person lift was required where planes, barges, and boats were involved. Setup time was 30 minutes for the camera, table, laptop, and chair.The software used by mobile screening clinics was a combination of IMAGENet  and the The retinal images that were captured during the clinics were securely uploaded, stored, and backed up on a daily basis. This was an important consideration for First Nations in BC, as autonomy and ownership of First Nations data is foremost in the adoption of new health information systems. The First Nations Principles of Ownership, Control, Access and Possession (OCAP) apply the concepts of self-determination and self-governance to research, statistics, and information involving First Nations communities. The Inter Tribal Health Authority ensured that the project strictly adhered to OCAP principles.All data was stored at the ITHA data center, a First Nations operated data storage facility located in BC. The Inter Tribal Health Authority is a First Nations organization; it controls, stores, and owns the data collected in the project. It is on Snuneymuxw territory enabling the physical possession of the data on First Nations land consistent with the OCAP protocol.Training and capacity building for the teleopthalmology project include three unique aspects: specialized one-to-one training, job shadowing, and capacity building among First Nations youth. Detailed logs by clinic members were kept and reviewed to continually improve project operations.Specialized one-on-one training for team members with an SDI and teleophthalmology expert addressed clinical processes and client care, retinal image photography, equipment maintenance, secure image transmission, mock clinics, and cultural protocols.Job shadowing took place in the offices of the grading physicians—the ophthalmologist in Comox, BC and the retinal specialist in Victoria, BC. During these work experiences, the nurses and technicians were able to see how the clinics operate, how retinal scans were taken, and how clients were treated in busy urban practices.One of the known deficiencies in the aboriginal health field is the markedly low level of First Nations people trained in health care professions. The teleopthalmology project provided a capacity building opportunity to three First Nations youth and supported their continued education and work experiences.Each member of the teleopthalmology team maintained detailed logs of each clinic that was delivered. These logs were free-form, hand-written notes about team members’ experiences and lessons learned from each clinic. They pertained to logistics of booking the clinics, equipment, perceived assessments of the clinics, and observations about cultural protocol. The hand-written notes were converted to electronic format by the technicians upon returning to ITHA offices. They were all incorporated into a Microsoft Word document that continued to be updated with information to assist in the continual improved provision of the clinics.The evaluation for the teleopthalmology project involved multiple data collection sources and activities. These were: utilization measurement, system and use measurement, community health provider feedback, and operational cost measurement.The ITHA teleopthalmology team conducted analysis for the various data collection activities. The primary author of this paper worked with the second author  to synthesize this analysis, conduct additional analysis, and develop the paper.Individual client records from the SDI database were summarized and compiled for analysis. Reports from the SDI program were used to produce summaries from the retinal screening clinics. These included the number of clients screened, the number of clients referred, and the results of diagnoses by the grading physicians.The System and Use Survey (S&U Survey) was developed by Canada Health Infoway as a tool to assess quality and use of health information technology systems and also to flag obstacles to the adoption of systems and the realization of net benefits from them. The S&U Survey was customized to consist of 25 questions and was designed to determine initial reaction to the screening solution in relation to quality, productivity, and access. The S&U Survey was developed in a web-based format using SurveyMonkey and sent via email to clinicians involved in the teleophthalmology project. Clinicians were also given the option to request and submit a paper version of the survey.Survey results were extracted and interpreted by the ITHA project team using simple univariate analyses.The Community Health Provider Feedback Survey was developed by ITHA for this project. The survey, which was administered using SurveyMonkey, consisted of 10 questions. It was designed to solicit feedback on the retinal screening clinics from those who deliver health care in each of the communities. It asked respondents to identify areas where the retinal screening service could improve, to identify areas where expansion of services could be offered, and to identify opportunities to increase client education and health promotion. The teleopthalmology project team sent a Web-based survey via email to 22 community health care providers from communities that had received retinal screening clinics during the past 11 months.As with the S&U Survey, results from the Community Health Provider Feedback Survey were extracted and interpreted by the ITHA project team using simple univariate analyses.Operational costs to support the delivery of the retinal screening clinics were examined and compared to what could be identified as pre-teleopthalmology costs for retinal screening.Travel costs for each of the First Nations communities were tabulated based on then-current Non-Insured Health Benefits (NIHB) Health Canada reimbursement schedules. Additionally, Medical Services Plan (MSP) base costs for Optical Coherence Tomography (OCT) scans, general practitioners, and specialist referrals were applied to the relevant points in the service delivery model.A value for average client travel cost was provided by the NIHB program. Travel costs for each First Nation were based on the distance to the nearest ophthalmologist, calculating the cost of a return trip to and from that ophthalmologist for each client. An additional 15% of travel costs were added for those cases where an escort for the client was required. This 15% value was recommended by the NIHB team, based on historical travel records.Teleophthalmology screening was conducted in 43 of the 51 First Nations communities on Vancouver Island in the first year of operation . These First Nations communities are listed in In these 43 communities, 524 diabetic and at-risk individuals were screened. The retinal screening revealed a variety of eye disease and health problems apart from diabetic retinopathies. Other conditions that were diagnosed included cataracts, glaucoma, hypertension, macular degeneration, and other vascular diseases.Of the eight participants invited to take the S&U Survey, seven individuals responded. All seven used the electronic format of the survey. These participants were teleopthalmology team members, including the system administrator.Five of the seven respondents were highly satisfied with the system in terms of ease, functionality, quality of information given, and quality of services provided for the system. Two respondents were moderately satisfied.Six out of seven respondents strongly or moderately agreed with the following statements: “the system improves my productivity”, “the system improves the quality of care I can provide”, “the system makes my job easier”, “the system enhances our ability to coordinate the continuity of care”, and “the system enhances the efficiency of ordering retinal screening referring clients for onward treatment client follow-up”. For all of these, one respondent (the system administrator) indicated that these were “not applicable”.For the following two statements, five of the seven respondents indicated that they strongly or moderately agreed and one indicated that she/he moderately disagreed: “the system improves our sharing of client information amongst providers”, and “the alerts, reminders and order set features  improve the quality of my decision-making”.Three of the seven respondents answered an open-ended question about aspects of the system that they would change, and if so, what they would be. These included better integration of the SDI tool with other health systems, more flexible reporting, the addition of mobile units to increase speed and efficiency of screening, and additional information provided in reports.Two of the seven respondents answered an open-ended question about describing experiences with the system where it had supported the provision of care. One of the respondents, the system administrator, described witnessing the expedited manner in which providers conveniently worked together to identify conditions requiring immediate attention and avoiding dire clinical consequences. The other respondent attested to the timely and effective manner in which specialist care was provided to clients.Of the seven respondents, five rated the system as being highly acceptable and two indicated that it was moderately acceptable.All seven respondents strongly agreed with the statement: “the system is reliable in its performance”. All seven respondents moderately agreed with the statement: “the system is integrated with my workflow”.For the following statements, six respondents strongly agreed and one moderately agreed: “the system is easy to use”, “the response time is acceptable”, and “overall, the quality of the system is excellent”.Four respondents strongly agreed, and three respondents moderately agreed with the statement: “the system features enable me to perform my work well”.For the statement “the system security is acceptable”, five respondents strongly agreed, one moderately agreed, and one did not answer.Four respondents rated the quality of the information provided by the system as highly acceptable, and three rated it as moderately acceptable.The distribution of responses to statements regarding information quality were varied. Three of the seven respondents indicated that the quality of the services  provided for the system were highly acceptable.For the statement “the implementation process within the Vancouver Island Health Authority catchment area was acceptable”, one respondent strongly agreed, four moderately agreed, and two indicated that they were not sure.For the statement “the current level of training is acceptable”, four respondents strongly agreed and three moderately agreed.Three respondents strongly agreed with the statement “the level of on-going support provided is acceptable”, whereas three moderately agreed and one was not sure.Users were asked how many times they use the system in a typical day. Four respondents indicated that they used the system constantly throughout the day. The other three respondents indicated that they used the system two to three times per day, one time per day, and three or four times per day. One respondent indicated that they used the system only 1 day per week, and did not specify how many times they typically used the system on that 1 day a week.One respondent indicated that they used the system three or four times a day. Three respondents indicated that they used the system 5 days a week. Another respondent indicated that they used the system 3 days in a week.Respondents were asked to indicate the percentage of their clients for whom they used the system. Of the six respondents to this question, four indicated that they did not know. Of the two respondents, one indicated 100% of clients and the other respondent indicated 95%.All seven respondents indicated that they would definitely recommend the system to health care providers at other hospitals or centers.Four respondents indicated that they would, given a choice, moderately increase their future use of the system. Two indicated that they would significantly increase use, and one respondent indicated that they would remain with the same use.Two respondents provided additional comments in the survey. The comments related to future desired and planned functionality. One respondent indicated that the new business intelligence system connected to the SDI system would provide more progressive reporting in the future. Connection with Electronic Medical Records (EMRs) or “health networks” was also indicated as desired future functionality.Of the 22 community health providers invited to take the survey, 11 individuals responded. Responses to questions that did not relate to the teleopthalmology screening clinics, but rather current staffing complements, care delivery models and service provisions, are not included in this paper. These questions were included to inform ongoing development and deployment of teleopthalmology services.With regard to being satisfied with how the retinal screening clinics were conducted in their communities, four of the respondents strongly agreed and six agreed.Satisfaction with various aspects of how the ITHA retinal screening clinics was measured. Most were very satisfied or satisfied with all aspects, with very few neutral responses. No respondents were dissatisfied or very dissatisfied with any of the aspects. Results from the eight respondents to this question are summarized in The survey listed potential areas for improvement for the teleopthalmology screening clinics. Two respondents cited that clinic scheduling could be improved. Communication with ITHA, length of clinics, and sharing of client results were each identified by one respondent as potential areas of improvement.Six of seven respondents to the question about whether ITHA retinal screening clinics helped to raise awareness of diabetes self-management among participating community members indicated that they neither agreed nor disagreed. One respondent agreed. Four respondents skipped this question.No respondents indicated any problems occurring during retinal screening clinics.Costs were calculated using the assumption that teleopthalmology removes the need to have referrals from a general practitioner (GP) or ophthalmologist.The average per client total cost for traditional ophthalmology screening, according to MSP fees is CAN $647.15 . The average per client travel cost for those clients who would have had to travel to see a specialist for a retinal scan was estimated to be $211.96. This figure was provided by the NIHB program, which provides payment for client travel. This amounts to a total cost per client of $647.15 for the traditional ophthalmology model.The average per-client cost of teleopthalmology was CAN $590.81. A cost of $553.15 was incurred per client, according to ITHA general ledger entries for teleopthalmology operations. This included the salaries of the teleopthalmology team, travel costs, and medical supplies. In addition, the cost for an ophthalmologist to grade a retinal screen for the teleopthalmology project was $37.66. The direct per-client cost of teleopthalmology was CAN $56.34 less than the direct per-client cost of traditional ophthalmology screening.The teleopthalmology project nearly achieved its goal of screening 600 clients in the first year through the delivery of the clinics via a single mobile unit and limited resources. One of the practical benefits of the teleopthalmology project was the establishment of a rough baseline of those individuals who were either at risk of diabetes or suffer from type 1 or type 2 diabetes. ITHA will now be able to use this baseline to monitor these individuals and provide additional preventative services in an effort to minimize complications and long-term detrimental effects.The 140 clients who were referred by grading physicians were diagnosed with conditions  that may have gone undetected and untreated for long or indefinite periods of time. In addition to the direct cost savings measured for this project, the savings of various indirect costs of worsened and further-progressed conditions  are possible benefits of the project. Many of the clients screened (and referred) may not have otherwise received care if it had not been made accessible to them via the teleopthalmology project.Overall user satisfaction with the teleopthalmology system was high. System quality, information quality, and service quality all received favorable ratings.User experiences with the teleopthalmology system were positive. Respondents planned to use the system no less than before or at the time of the survey. All seven respondents indicated that they would definitely recommend the system to health care providers at other hospitals or centers.Providers in the First Nations communities rated the setup and operations of the clinics favorably. No dissatisfaction with any aspects of the clinics was indicated. A higher rate of participation from these community health providers would have been desirable to obtain a representative and comprehensive assessment of the teleopthalmology clinics.The direct average cost savings per client was calculated to be CAN $56.34. The figures used in this evaluation underestimate the cost savings that teleophthalmology offers on an ongoing basis. The main reason is that the capital costs of the teleopthalmology project were included in the analysis; these initial costs were not intended to result in a return on investment in monetary terms nor were they limited to the timeframe of the project and evaluation. The setup cost for relevant components of the traditional health care system was not feasible or included for comparison. As well, the project now operates as an ongoing program, which benefits from greater economies of scale and efficiencies identified throughout the project. Importantly, teleopthalmology was not intended to be a cost-saving project or program, but was intended to improve quality of and access to health care services for First Nations communities.Although not assessed in this evaluation, there are additional intangible and health-related benefits to clients and caregivers associated with the elimination of travel costs and increased access to screening services . Other potential and indirect benefits that were not assessed include savings in terms of environmental and ecological impacts associated with travel to access health care services. Although not measured in this project, non-monetary impacts on client and caregiver travel such as physical exertion and stress are potential benefits to teleopthalmology.Demonstrating support for First Nations youth contributed to the successful acceptance of the retinal screening clinics in First Nations communities. The project has also supported capacity building among First Nations people. The two technicians were of First Nations descent; they have gone on to pursue formalized accredited training as ophthalmic assistants.The evaluation of the teleopthalmology project involved a limited focus on teleopthalmology operations, usage, and costs. Future study could explore the impact of teleopthalmology on local and regional health systems as well as health outcomes of First Nations clients.A low survey response rate from community health providers yielded a limited understanding of communities’ experiences with the teleopthalmology project.Following the initial year of operations, the teleopthalmology project became an official program.At this time, the teleopthalmology program serves 50 of the 51 First Nations communities on Vancouver Island, with approximately 1300 active clients. The teleophthalmology program now focuses on serving diagnosed diabetics, based on a synthesis of evidence that did not find a clinical benefit of retinal screening for non-diabetic clients .There are now two mobile clinics that provide teleopthalmology services across Vancouver Island. Currently, the referral rate is 19.64% . This may result from a reduced need for treatment and stabilization of health outcome.The teleopthalmology program receives ongoing funding by the Aboriginal Diabetes Initiative  in BC, which was previously First Nations Inuit Health). The FNHA was established in 2013 as the first Canadian provincial health authority responsible for the planning, designing, management, delivery, and funding of First Nations health programs on a provincial level.With time, the actual cost savings for the teleopthalmology program have increased compared to the cost savings measured in the teleopthalmology project. Improvements in clinic scheduling have led to the increase in the number of clients that receive retinal screening per clinic. Related to this, improved planning of clinics have contributed to reduced travel costs as multiple clinics are delivered per trip.Moving forward, additional program costs may decrease with the potential successful establishment of an MSP fee code for Telehealth services that would reimburse grading physicians for their services. Currently, the FNHA provides this funding for grading physicians. During the teleopthalmology project, before the FNHA was established, the federal government via First Nations and Inuit Health (FNIH) provided this funding.Empowering First Nations youth, in particular those with a willingness to reconnect with their peoples, has been a major point of success with the teleopthalmology program and continues to be a goal of the program. First Nations youth are considered to be uniquely qualified to engage with communities, as they understand the cultural protocols and landscape. The teleopthalmology program ensures that job postings reach youth in First Nations communities. It targets First Nations youth training centers, community events such as health and career fairs, and university First Nations study programs.


Background. The Meningitis Vaccine Project (MVP) was established to address epidemic meningitis as a public health problem in sub-Saharan Africa and, to that end, worked to develop a group A meningococcal conjugate vaccine, PsA-TT.Methods. Experiences in 4 clinical trial sites are described. Culturally sensitive collaborative strategies were adopted to manage acceptable communication methods, peculiarities with the consent process, participant medical issues, community care, and death.Results. The clinical trials were completed successfully through community acceptance and active community collaboration. The trials also strengthened the capacities in the participating communities, and actively worked to resolve community problems.Conclusions. The understanding and integration of sociocultural realities of communities were major assets in the conduct and acceptance of these trials. MVP succeeded in these sites and provided a sound example for future clinical studies in Africa.Clinical Trials Registration. ISRTCN78147026 (PsA-TT 002); ISRCTN87739946 (PsA-TT 003); ISRCTN82484612 (PsA-TT 004); PACTR ATMR2010030001913177 (PsA-TT 006); and PACTR201110000328305 (PsA-TT 007). The Meningitis Vaccine Project (MVP) was established to offer a solution for meningitis as a public health problem in Africa. To meet this goal, the project developed a group A meningococcal conjugate vaccine , which was tested for safety and efficacy in countries and populations that would benefit from such a vaccine. However, conducting clinical trials in resource-limited communities is challenging. Ensuring that the PsA-TT vaccine was of the highest quality was a key factor in obtaining the trust and cooperation of the people for whom the vaccine was developed. While international (largely Western) standards exist to ensure data quality as well as protecting the rights and safety of trial participants , studiesThis article focuses on the clinical experiences in the following African sites: (1) Medical Research Council (MRC) Unit, The Gambia; (2) Navrongo Health Research Centre, Ghana; 3) Centre pour le Développement des Vaccins (CVD), Mali; and (4) Institut de Recherche pour le Développement, Senegal. We emphasize community considerations and experiences in the conduct of studies in African sites and highlight important lessons learned from these sites. Specifically, we detail the communication systems in these communities, the informed consent process, issues of medical care in rural communities with suboptimal healthcare systems, and capacity strengthening. We also describe how the death of a trial participant was managed. More technical results from these studies are described in accompanying articles  Centre p.The trial sites in The Gambia, Ghana, and Senegal were largely rural whereas the Mali site was located in Bamako, the capital. The predominant religion in The Gambia, Senegal, and Mali sites is Islam, accounting for 90%, 77.5%, and 95% of populations, respectively, whereas at the Ghana site Christianity is the predominant faith. Literacy rates are low at all sites, with subsistence farming, cattle rearing, and trading being the major sources of income. Despite recent improvements in health indices, these areas suffer high under-5 mortality: 98, 61, and 45 per 1000 live births in Mali, Ghana, and The Gambia, respectively [A sound and robust communication system in rural communities, and between health institutions and governments, is a key element for the success of a clinical trial. After receiving permission to begin the trial from the relevant government agencies and ethics committees , meetingdurbars. In Senegal, the badiénou Gokh  play a major role during these meetings. These meetings serve to create a sense of partnership and to provide the opportunity to answer questions regarding the current or previous trials that may be raised by the communities.This initial meeting sought permission for the trial team to carry out the trial in the community. In The Gambia it is customary to take kola nuts to the village elders to bless the contact. Similar events were organized in Mali after leaders had informed the public, usually at Friday prayers or through a network of advisors. With the support of these leaders, large community engagement meetings were then held. In Ghana, these large meetings are termed Local health teams, village reporters, and community liaison officers also play a significant role in sensitizing the communities; hence, it is essential to inform them of potential studies and to seek permission to use their facilities where appropriate. Local journalists were also contacted at the start of each trial, to ensure the transmission of correct information as well as to cultivate these relationships in the event that further media coverage was required or if something went wrong .After community participation was assured, potential participants were then approached depending on the trial requirements. In studies involving children, the consent of husbands or heads of the compound was usually obtained. This is particularly important in rural settings , 12. MotRumors, usually negative, are known to be potentially disruptive in any clinical trial . To avoiTo better manage rumors, the Mali site established a communication and crisis management team. This team was composed of members of the community , the chief neighborhood medical officer, women's and youth representatives, investigators , fieldworkers, and the internal communication team leader. This team held regular meetings to share information about the trial and the trial population and sometimes met heads of families to discuss specific concerns. In Senegal, 1 or 2 members of the trial team were designated to specifically manage rumors under the supervision of the PI. These persons were authorized to communicate on the project with the media and to the community  allows for the consent of legal guardians . In thesAn impartial witness is required by GCP when obtaining consent from illiterate participants . A majorTrial participation was viewed by some as a sign that their child was considered healthy. However, in Mali, many mothers also expressed fear that their child may come down with meningitis, the illness the vaccine was designed to prevent.Refusals/withdrawals tended to stem from community or family perceptions. For instance, a participant >18 years of age withdrew from the trial: his father had been away at the time the trial started, but was consulted on his return home. As the father, he needed to assert his final say in participation irrespective of the fact that the participant was above the legal age for that country.In some settings, issues concerning blood and blood draws are sensitive, and if not properly handled could jeopardize a trial. Due to the low literacy rate, the  amount of blood that is collected could be scary, especially in infants. In some places, it is believed that taking the blood of children could make them ill. Hence, blood sample collection played a major role in refusal or withdrawal from the trial. In addition, questions asked before consent mainly centered on the procedures to be carried out, what would be done with biological samples that were collected, and why so many forms needed to be understood and signed before enrollment. MVP conducted a safety trial that recruited about 6000 subjects in Bamako, Mali. There was no blood draw in the trial, and the experience suggested that recruitment was comparatively easy and the participants’ completion rate was high compared with trials requiring several blood draws .In MVP studies, clinical care was offered to all participants in line with the treatment policy of the countries. In sites with clinical trials experience, it is perceived that the quality of care given to trial participants is better. The availability of medical care appears to be a major incentive for trial participation. Moreover, former participants continued to visit the site to request care even after the studies, further indicating that the availability of quality of medical care is considered important. In practice, trial clinicians also provided counsel and care to immediate family members of the participants.Communities further benefited from improved medical care when recruitment and other clinic activities were conducted in communities rather than in the hospital. Normally, community clinics are staffed by community health nurses, but during the trial, trial doctors also provided medical care at these facilities, and supervised the community health nurses, which likely led to better patient care. This indirect benefit to the community is often used as an argument for clinical trial participation, especially in community meetings and durbars.Mention should also be made of special programs instigated in response to the needs in the community. In The Gambia and Mali, clusters of children with malnutrition from a certain region were observed. Following a recommendation by the data safety monitoring board (DSMB) that the team intervene, a community mobilization effort was mounted in the worst-hit communities to demonstrate how to provide healthy meals for infants with locally available food. In addition, a monitoring system was established that was based on World Health Organization standards. Regular deworming of children was also done. These efforts were much appreciated by the community, and communities took ownership by assisting in running such demonstrations. Four years after the trial began and at the kick-off meeting for the antibody persistence study, this community intervention to improve nutrition was still a major topic of discussion at the community meetings, with key leaders applauding the research team's efforts and impact.In Navrongo, Ghana, it was noted during the course of the trial that there was a high incidence of malaria in the infants recruited in the trial, resulting in large number of serious adverse events. After consultation with the DSMB, MVP undertook an insecticide-treated bed-net distribution campaign in the trial area. This distribution was targeted not just at trial participants, but at all families in the community with children <3 years old. Data collected from the local district health units suggested a reduction in the number of confirmed cases of malaria.Formal autopsies could not be conducted at most sites, either due to the religious requirement to bury the deceased within 24 hours of death or the unavailability of autopsy facilities. Verbal autopsies were used to define the possible causes of death, especially when the participant did not die in hospital. The trial teams in each site expressed their sympathy and condolences. When necessary, further support was offered, for example, in transporting the deceased to the family. Such support further deepened the trust in the investigative team by conveying a message of genuine care and respect for the culture of the community.MVP studies helped to strengthen the capacity in the sites where they were conducted. In Basse Health Centre, The Gambia, at the CVD clinic in Mali and at the Toucar health post in Senegal, facilities were upgraded. For all sites, new equipment was supplied, such as resuscitation equipment and refrigerators that would benefit the facility beyond the duration of the trial.Trial staff were regularly trained and new skills offered .In Ghana, MVP contributed to the writing and revision of guidelines for the treatment of common illnesses in the children's ward of the district hospital. In The Gambia, the children's ward of the local health center was refurbished, and regular training in management of common ailments was provided for local health staff. The 4 MVP trial sites are also health facilities for the surrounding communities, and the conduct of clinical trials ensured an investment in the quality of these facilities.The understanding and integration of sociocultural realities of a community are major assets in the conduct and acceptance of clinical trials. Most challenges observed were due to the cultural, economic, and epidemiological setting, and the bottom-up approach to the interventions was very successful. Despite religious differences at sites and between sites, there were no major differences in the challenges encountered between sites. Attempts by the trial team to help reduce community problems increased the trust communities had in investigators because it highlighted important community issues beyond the trial. MVP has made an important mark across all of its study sites and left an example that, if emulated, could facilitate future studies.


Introduction: Interprofessional education (IPE) is receiving growing significance both nationally and internationally. Despite this, organizational and curricular changes are posing challenges. The level of need for IPE and how changes can be made to curricula and infrastructure were investigated at the University of Erlangen in Germany.Method: The student working group for interprofessional teaching (AGIL) has turned its attention to these issues. This group is composed of students from medicine, dentistry, molecular medicine, medical technology and speech therapy. In June, 2015, a needs analysis was carried out among the students in the study programs represented in the working group to assess the actual and target situation concerning IPE . In the search for answers and to better measure any needs, contact was sought with instructors.Results: The majority of students feel that they are insufficiently educated in terms of interprofessional skills. A large proportion of the students wish to see expansion of the IPE offerings. Students also expressed a desire for additional spaces and welcomed the idea of an interprofessional learning center. AGIL began establishing interprofessional electives in October 2015. A concept for an interprofessional learning center was developed.Discussion: Based on the survey results, a need for improvements to curricula and infrastructure can be seen; however, the results are limited to the student point of view. AGIL would like to establish more interprofessional electives. These courses would then facilitate curricular implementation. Modern ideas about study environments could be applied to IPE, in particular to promote informal forms of learning. Contact with instructors was crucial for the project work and should be expanded. Realizing and financing the learning center in Erlangen are now the future goals of AGIL. The aim is to create a foundation for this purpose. Our healthcare system is shaped by the interplay of different skilled professions ranging from academic professions to newly specialized programs for vocational study. All of these professionals perform their work with the goal of providing the best health care possible. To accomplish this, sharing and exchange between these groups is indispensible.Internationally, interprofessional education (IPE) is becoming an increasingly permanent component of medical education. A good example of this can be found in the United States where approximately 90% of medical schools indicated in a survey that they offer interprofessional courses and clinical teaching. More than half had created an office or center specifically for IPE . In Greahttp://www.nklm.de].While initial experience is being gathered with IPE in Germany’s healthcare sector, the exchange between the health professions has not yet reached sufficient levels. The IPE committee of the Gesellschaft für Medizinische Ausbildung (GMA) is calling for the development of an overall philosophy for IPE. The problems which have been identified are primarily of an organizational or systemic nature. There is still much to learn, and those in research are only just starting to turn their attention to this field . The Gerhttp://tu-dresden.de/die_tu_dresden/fakultaeten/medizinische_fakultaet/inst/mpz], as well as entire campuses dedicated to interprofessional learning such as the Hochschule für Gesundheit in Bochum [http://www.hs-gesundheit.de/de/thema/die-hochschule/]. While on a campus of this nature most of the education takes place at one location, in skills labs student learn practical and communication skills only in connection with specific segments or parts of the particular educational program.The necessity of fulfilling organizational, infrastructural and curricular pre-requisites to successfully implement IPE is constantly being pointed out, and was already taken into consideration by the OECD in its concept of a “health university” in 1977 . In termTo date, interprofessional collaboration has taken place at the medical school of the Friedrich Alexander University in Erlangen-Nuremberg (FAU) only in individual instances. Joint courses in different fields are offered . Aside from these isolated points of intersection, this kind of interdisciplinary communication appears otherwise absent from the curricula. There is still great potential within the infrastructure for accommodating IPE in Erlangen. Based on these considerations the following issues come into focus for Erlangen:Current situation: Is the need for IPE met in Erlangen from the student perspective?Target situation: Do students desire more IPE in their education?Which concepts pertaining to curriculum and infrastructure could be used to implement IPE in Erlangen?To address these questions, the student working group on interprofessional teaching (AGIL) was created in December 2014. AGIL presently consists of students pursuing studies in medicine, dentistry, molecular medicine, medical technology, and speech therapy. These students have all completed varying numbers of semesters.During weekly meetings, an atmosphere for effective project work was created with the help of soft skills training. In May, 2015, a planning meeting was held to generate a definitive timeline for accomplishing tasks. The questions above were first answered in independent subgroups of the working group. A leader was appointed for each subgroup.To respond to questions 1 and 2, the subgroup dealing with evaluation surveyed students in medicine, medical technology, dentistry, and molecular medicine in June 2015. In addition, data was gathered regarding the current student take on IPE. The student surveys asked about the exchange between the health professions and the current study space on offer. Students in the clinical phase of their education also gave their assessment regarding the existence of selected interprofessional core competencies . Opinionresearch continued to compile information on the academic context of IPE. The subgroup concerned with academic courses developed (extra-)curricular electives and required electives, while the subgroup addressing concept worked on infrastructural approaches to meeting an increased need for IPE.To find answers to the third question, three other subgroups grappled with possible solutions. Functioning as an information point of contact within the larger working group, the subgroup dealing with In addition, the working group took on the responsibility of establishing contact with university instructors to raise awareness about IPE and to work on concrete improvements for Erlangen. This was crucial to ensure the needed support of the faculty to sustainably realize such a project as this one. For the purpose of defining the later level of engagement, three different activity profiles were set down: consulting, establishing academic course offerings, and participating on a task force. The task force assumes responsibility for elaborating on the legal and economic aspects of the curricular and infrastructural concepts.The survey results were analyzed in terms of the defined issues and the following presents the results for each study program accompanied by a summary.A total of 846 medical students, 158 medical technology students, 59 molecular medicine students, and 42 dental students responded to the survey, meaning that 1,105 of 4,048 students (27.3%) took part  and at all semester levels  were surveyed in regard to interprofessional core competencies  felt their education was rather not preparing them well for work in multiprofessional teams .During their later careers, medical and dental practitioners are most directly involved in patient care. Of these students, most feel themselves rather unprepared to take the diagnoses and therapy options used in other health professions into account .Issue 2:To investigate if students desire more IPE, all survey participants  were asked about their preferences  are rather dissatisfied with the opportunities for interaction with students of other health professions A large percentage of students wish for more joint courses with students of other health professions .Issue 3:Based on the information gathered, the subgroup within the working group dedicated to academic courses intends to expand the IPE course offerings, specifically in terms of electives. In October, 2015, case history groups were introduced for students of psychology, speech therapy, dentistry and medicine. The intention has been to offer a seminar in implantology for dental, medical, and medical technology students starting in August 2016. Contact has already been established with sponsors to finance this seminar.As a basic pillar for implementing IPE in Erlangen, an interprofessional learning center for medical education (ILMA) has been envisioned to serve as a central meeting point on campus for students of medicine and the other health professions. Specifically, skills labs and spaces for study and recreation are to be included in an attempt to push the ILMA beyond the basic concept of the interprofessional skills lab. Characteristics of an integrated campus are partially embraced: the housing of (extra-)curricular courses at the learning center will be limited to IPE. Above all, this learning center is to be a place for individual study. Exchange between students can, however, be a self-evident component of studying and free-time activities. With the current research undertaken at the university and later career options presented at one central point of contact, an atmosphere for innovative joint projects can also be created.To determine student need for such a learning center, all survey participants were asked about the currently available spaces in Erlangen  and molecular medicine (56.0%) are most likely to assess the situation as poor. Even a substantial percentage of medical technology students are dissatisfied with the situation (43.7%). Only dental students are satisfied for the most part (73.9%).The majority of students desire a learning center with spaces for individual study and as a site for student interaction .Most instructors indicated a willingness to cooperate: 15 of the 25 instructors initially contacted responded to AGIL. Thirteen of these are able to envision being involved in general cooperation, with six of these serving as active members of the task force.The needs analysis presented here reveals several strengths and weaknesses. The time point of the survey can be regarded positively. AGIL had set itself the goal of raising awareness of IPE in Erlangen through public relations. To avoid falsification of the survey results, the survey was conducted prior to beginning any publicity measures. The survey’s response rate of 27% appears to be representative at first glance; however, the response rates for the separate study programs must be critically assessed. The low participation of dental students, particularly of those in the clinical phase of study (n=10), could lead to a bias in the results. Giving too much weight to this detail in the interpretation of the results should therefore be avoided. Furthermore, it must be noted that the method applied only accounts for student opinions. Only the dialogues held with instructors were able to roughly mirror the student point of view, something that is to be objectified in another survey. Since the three questions are specifically formulated to elicit the student point of view, the results of the survey was able supply answers to these.Issue 1:Although practicing physicians, as the central caregivers, always work in tandem with other health professions, they are very likely to regard themselves as poorly prepared by their education to deal with the additional diagnoses and therapy options offered by these other health professions (72.7%). Unfortunately, the results seen here for dental students cannot be viewed as representative (see above). Despite this, a need for more IPE can be inferred since the majority of respondents feel ill prepared for interprofessional collaboration in their later careers (66.5%). Due to the fact that at the University of Erlangen hardly any content regarding clinical practice is taught during the preclinical phase of study, an analysis of the current situation regarding the core competencies of medical and dental students at this level of study was not undertaken.Issue 2:Although, based on the results, IPE appears to be relatively well established in dentistry, the low rate of response also limits the ability to interpret the results. Furthermore, the majority of the other three study programs voiced dissatisfaction with the opportunities for interaction with students of other health professions (71.4%). At the same time, the majority from all study programs desired more joint courses with students of other health professions (64.6%).Issue 3:academic courses is necessary. This will allow for piloting to provide experience to identify the best curricular options for implementing IPE. Ultimately, this must take place to make IPE accessible to all students. A further responsibility of the subgroup evaluation will be monitoring these (required) elective courses.The analysis of the actual and target situations resulting from questions 1 and 2 shows that IPE should be more broadly present in study programs. However, it is impossible to conclude from the results how this should happen. The creation of new (required) elective subjects by the subgroup for The situation regarding space was evaluated negatively by a large part of the students. Only dental students seem to be satisfied for the most part. This could be traced to the fact that a large part of the teaching is done in a well equipped teaching hospital. A central medical learning center, in alignment with the vision of ILMA, was positively seen by all students regardless of major focus.A comprehensive concept for a health campus is certainly offered by the model of the health university. Partial aspects of the health university could be applied to our concept. In the review by Sottas et al mentioned in the introduction, spatial design, architecture and the logistics of patient management are given a major role . AccordiThe center must be sufficiently equipped functionally and integrated into the university. Very significant in this regard were the dialogues with the instructors. For, only by doing this it was possible to bring attention to IPE. The criticism that was expressed in these conversations was essential for honing the overall concept. At the same time, the support shown by the instructors confirmed our previous decisions and actions. In the future, AGIL will continue to draw on university instructors as cooperative partners and important sources of information. A newly founded society to promote IPE could function as a contact partner for both university and off-campus interests, provide incentive to establish IPE, and facilitate the financing of courses. The aim is ultimately the creation of a foundation to finance the learning center.Whether or not such a center would induce students to engage in individual learning and improve contact between different health professions must be investigated. The extent to which the conception of such a center can support education research is also of interest. The question is also raised as to whether or not the basis for interprofessional research projects is created, meaning that there are qualitative effects for the university as an academic institution. Not least, the center could serve as a central point of convergence for university and off-campus institutions.Conducting the evaluation illustrated the need for IPE and infrastructure and laid the foundation for future evaluations of the project’s influence. The working group was able to come up with ideas to improve the situation in Erlangen that also met with instructor approval. International insights on IPE and modern recommendations for designing study environments suggest an approach that simultaneously changes curriculum and provides state-of-the-art learning space. In light of the evaluation results, the information gathered from speaking with university instructors and the national and international recommendations, AGIL has taken on the curricular implementation of IPE and the realization and financing of the new learning center as its new project goals.Over the long term IPE should become established across Germany. Building a network for the purpose of sharing information could be useful. AGIL is ready to share its knowledge and experiences with other student working groups.The authors declare that they have no competing interests.


The author of this book wants to reveal ways leading to more confidence and calmness in exams and while performing in front of small or larger audiences. A short introduction is followed by a definition of the term stage fright and a distinction between useful and obstructive types (stage fright). The complexity of the phenomena stage fright and exam anxiety is vividly visualised on the basis of a mind map. The following chapter with the heading “What to do” and “How to address which issues?” lead to first action steps. Worksheets provide a substructure for the first evaluation of the obstructive symptoms. The following chapter deals with the scope of action that occurs while working on symptoms and causes of stage fright and exam anxiety. The author uses examples to illustrate the connection between nonverbal communication, the sound of the voice, speaking pattern and attitude, followed by stimulations and tutorials about body language and voice improvement. Two chapters address to mental preparation and the resulting solution approaches, as well as to the influencing factors. Chapter 1 deals with the enhancement of self-acceptance and the author’s distinction between “perfect” and “optimal”. For this purpose the chapter introduces helpful relaxation techniques. In Chapter 2, the author focuses on the causes of stage fright and exam anxiety. He introduces methods of goal attainment, activation of resources, self-negotiation and their specific effects. These techniques of the NLP (neurolinguistic programming), the Wingwave-Coaching, auditive kinaesthetic Intervention, a variation of knocking techniques and kinesiological exercises belong to these methods of goal achievement. Additionally, the book gives a substantial overview of helpful coaching- and therapeutic methods, customized for these challenging occasions. In addition to this, the book address a adapted diet and the usage of endogenous drugs. Chemical stimulants and their effects are mentioned and discussed controversially. The book ends with elaborated checklists, which can be helpful to prepare presentations and exams successfully.2)… and another book concerning the topic of stage fright, performance and exams anxiety. A range of guides can be found.Viewing the phenomenon of stage fright from different angles and to propose reconciliation with useful stage fright, seems to be a sensible approach. The author demonstrates convincingly how the outer, observable features such as mimic, gesture, voice and posture influences the inner posture respectively inner doctrines…and also vice versa by mental preparation techniques. On the basis of citations, examples and own experience the author, as a trained actor and studied linguist, succeeds to render the complex and delicate topic stage fright and exam anxiety accessible to the reader. However, a lot of the citations used in examples might miss their mark with the younger generations since the cited persons stem from a previous generation. Additionally the book contains two parts with anecdotes concerning women, which seem a bit old-fashioned. The contents between the chapters mental preparation 1 and 2 are adaptable and therefore useful. Here one can find useful suggestions to structure different presentation formats, to handle disturbances, possible technical breakdowns and blackouts during a presentation confidently. The extensive view on the complexity of stage fright and exam anxiety is one of the strengths of this book. This can especially be found in the two chapters on mental preparation. This part warrants careful and thorough reading, because it lists an extensive selection of academically and experientially proven methods for all those who are interested. Those are useful application methods of short and long term positive influence. The book by Cersten Jacobs seems right for those, who are willing to make a decision concerning their professional challenges. Examinees, teachers or individuals undergoing training who want to start acting. It`s for those who are determined to address their issues and provides them with the necessary tools to achieve their aim. The required tools are described extensively and comprehensively. The author declares that she has no competing interests.


Excessive alcohol consumption has significant adverse economic, social, and health outcomes. Recent estimates suggest that the annual economic costs of alcohol in Australia are up to AUD $36 billion. Policies influencing price have been demonstrated to be very effective in reducing alcohol consumption and alcohol-related harms. Interest in minimum pricing has gained traction in recent years. However, there has been little research investigating the level of support for the public interest case of minimum pricing in Australia.This article describes protocol for a study exploring Western Australian (WA) public knowledge, understanding, and reaction to a proposed minimum price policy per standard drink.The study will employ a qualitative methodological design. Participants will be recruited from a wide variety of backgrounds, including ethnic minorities, blue and white collar workers, unemployed, students, and elderly/retired populations to participate in focus groups. Focus group participants will be asked about their knowledge of, and initial reactions to, the proposed policy and encouraged to discuss how such a proposal may affect their own alcohol use and alcohol consumption at the population level. Participants will also be asked to discuss potential avenues for increasing acceptability of the policy. The focus groups will adopt a semi-structured, open-ended approach guided by a question schedule. The schedule will be based on feedback from pilot samples, previous research, and a steering group comprising experts in alcohol policy and pricing.The study is expected to take approximately 14 months to complete.The findings will be of considerable interest and relevance to government officials, policy makers, researchers, advocacy groups, alcohol retail and licensed establishments and organizations, city and town planners, police, and other stakeholder organizations. Excessive alcohol consumption has a direct negative impact on economic, social, and health outcomes. Regular moderate-to-heavy alcohol exposure is associated with numerous chronic health conditions, including liver cirrhosis, a range of cancers, and mental health problems -3. TreatIn Australia, studies by Collins and Lapsley  and the Against this background, investigating attitudes to minimum pricing in Australia is an important research priority for public health advocates interested in policy avenues to reduce excessive consumption. An understanding of the Australian public’s attitudes and beliefs toward minimum pricing will provide critical insights into the likelihood of acceptability or opposition and inform public information campaigns that may pave the way for its introduction. The aim of this qualitative study is to investigate public beliefs and attitudes toward the introduction of a minimum price per standard drink policy. The study will be the first to investigate perceptions regarding alcohol minimum pricing in Australia and it will not only seek to provide evidence as to whether the public will support the introduction of minimum pricing, but also perceptions as to what circumstances or conditions may maximize its acceptability.A panoply of alcohol control policies have been proposed and implemented worldwide to reduce excessive alcohol consumption . PoliciWhile several leading public health organizations  and organizations concerned with alcohol consumption in specific areas have voiced support for minimum pricing, public opinion on the policy is unclear. In fact, there is a dearth of studies worldwide investigating public opinion to minimum pricing ,15,19,21Few studies have investigated public opinion toward minimum pricing . An initThis protocol outlines the design of a study examining the knowledge, attitudes, and beliefs of members of the Western Australian (WA) public regarding a minimum price per standard alcoholic drink policy. The study will adopt a qualitative design to generate participant-led data on minimum pricing, including basic awareness, knowledge, and understanding of the policy and attitudes and beliefs toward its effect and possible introduction.The study will employ a qualitative design, involving focus groups to gain in-depth and detailed insight into the awareness and knowledge of minimum pricing in members of the WA general public, their attitudes and beliefs toward the policy, and suggestions for increasing acceptability if the policy was introduced in WA. The study will be conducted over a 14-month period and recruit 10-15 focus groups comprising 8-10 adults in each group. Focus groups will last approximately 1 hour, led by a trained facilitator, and follow a semistructured standardized question schedule  to ensurThe focus group schedule will be separated into 3 main parts. First, participants will be asked to indicate their understanding of the phrase “minimum pricing policy” with respect to alcohol. After assessing the participants’ knowledge, the facilitator will then provide a clear-language explanation of the policy for all participants. Information given by the facilitator will include a clear outline of the proposal, as well as previous evidence and findings related to the proposal. Second, the facilitator will subsequently enquire about participants’ attitudes and beliefs toward minimum pricing. Third, focus group participants will be asked to consider ways in which the policy could be made more acceptable and effective.In-depth discussion will be stimulated by the facilitator throughout each part of the discussion. Data will be recorded on 2 voice-recording machines placed strategically to capture all voices in the room. The facilitator will encourage participation in an autonomy-supportive manner and prompt participants to be candid in their views and freely elaborate on their responses. Visual aids will also be introduced and explained to participants to assist with their understanding of how the minimum price policy will affect the price of alcoholic beverages.Eligible participants will include WA adults from a diverse cross section of backgrounds, including students, blue/white collar workers, minority groups, unemployed, and retired workers. Individuals younger than 18 years of age will be ineligible to participate as they are not old enough to purchase alcohol in WA. Further, participants who are considered harmful drinkers, according to a screening tool administered prior to the beginning of the focus group , will be excluded. Any harmful drinkers identified during the course of the recruitment phase will be referred to alcohol awareness and counseling services.Participants will be recruited through targeted advertisements and the research team’s existing collaborative links with the community, including schools, local employers, local clubs and organizations, and job seeker’s pages in local newspapers and in Perth job centers. Advertising materials  will be developed to inform potential participants of the study aims and encourage them to contact the primary researcher to join a focus group. Posters advertising the study will be disseminated across the Perth metropolitan area, as well as emails sent to a wider catchment area in the neighboring suburbs of Perth. Email addresses will be sourced through word-of-mouth and Internet sites of groups and clubs.One focus group will be exclusively female as research suggests women are likely to hold particular views and beliefs regarding alcohol drinking . An addiGiven the paucity of research regarding public perceptions about minimum pricing, the adoption of a qualitative approach using focus groups is appropriate and fits well with the general aim to provide a comprehensive overview of people’s knowledge, attitudes, and beliefs of minimum pricing and to construct a model of the factors affecting the acceptability of the policy. Our qualitative approach will be data-driven following recommendations in the literature by qualitative research methodologists ,25.Although the approach is not guided by theory, it is not atheoretical. Instead, we will use a theory-building, inductive approach rather than a traditional theory-testing, deductive approach. Specifically, data in the form of transcripts of focus group discussions on minimum pricing will be subjected to inductive thematic content analysis  for releBased on Lonsdale et al , 10-15 fA research question protocol will be developed  to ensurThe study is expected to take approximately 14 months to complete. This includes 2-3 months for the development of materials . Approximately 1-2 months will be required for advertising and recruitment, followed by 4-5 months of data collection. It is then expected to take between 3 and 4 months to transcribe the data, analyze and agree on emergent themes, and write the results into a coherent framework.This study protocol outlines study methodology to investigate attitudes and beliefs toward minimum pricing and identify avenues for increasing acceptability in members of the WA general public. This study will be the first of its kind in Australia and add to a nascent literature exploring public opinion about minimum pricing . Given tAlthough the planned analysis will be inductive and focus on emergent themes generated from the data, such a process does not occur in a “vacuum” independent of other literature and previous research. Based on previous research we can therefore form a candidate list of themes that may emerge from the data . This wiThe unique perspective and in-depth exploratory qualitative approach are major strengths of the current proposed study. It is the first study to examine the public interest case for minimum pricing in Australia and will provide valuable information on the perceptions of the general public that may assist in the development of legislation and messages toward the introduction of the policy. Furthermore, the methodological approach facilitates in-depth exploration of participants’ views and beliefs, and the use of a predetermined question protocol enables group comparisons.There are some limitations with the current research. First, the researcher will not blind the study or background research. It may be the case that participants in each focus group ask the researcher for his or her views of minimum pricing. In this situation, the researcher will be briefed to remain neutral, will remind the group that the goal of the research is to canvas opinion and redirect the discussion to eliciting participants’ views and beliefs. Having an informed researcher is also an advantage in the context of the current study as confusion has been found to surround minimum pricing . Second,