This article illustrates some issues we faced during our experience in conducting an epidemiologic case–control study of inflammatory breast cancer in North Africa. We expect that some of the questions we had to ask in order to address these issues might be helpful to others in setting up epidemiologic studies in developing regions. We describe our experience from different angles including the use of multiple sites to achieve adequate sample size, standardizing diagnosis of disease, identifying cancer cases at the time of diagnosis, control selection procedures, logistics of study implementation, questionnaire development and interviewing, biologic specimens, and procedures for protection of human subjects. We have developed a brief checklist to summarize important issues for conducting future epidemiologic studies in these or similar low- or middle-income countries. Designing and conducting epidemiologic studies in developing countries can be very challenging due to lack of research and medical infrastructures at study centers, including personnel trained in epidemiology. In this manuscript, we share our experience in designing and conducting an ongoing epidemiologic case–control study of inflammatory breast cancer (IBC) in North Africa that included a molecular epidemiology component.For background, IBC is a rare, aggressive form of breast cancer characterized by the rapid clinical appearance of erythema (redness), edema, and peau d'orange of the breast. Several studies have reported that IBC constitutes a larger proportion of breast cancers in North Africa than in the United States , 2, althOur aim in this study is not to describe the specifics of the ongoing study on IBC, but rather to focus on issues that we faced in mounting this low-budget, low-technology study that might be pertinent to other epidemiologic studies in developing regions. These issues include (1) enrolling study subjects at multiple study sites to achieve adequate sample size; (2) standardizing the diagnosis of a disease that has a clinical component; (3) identifying study subjects with a specific disease before treatment is initiated from among many patients seen at study hospitals; (4) sampling cancers as a comparison group; (5) control selection procedures when cases may not be population-based and when hospital-based controls are not feasible; (6) logistics of study implementation in a low-technology setting; (7) development of questionnaires that are relevant to the study population; (8) collection of biologic specimens, including fixation procedures; (9) data management issues; and (10) issues regarding protection of human subjects. We also provide guidelines for determining whether other settings are feasible for conducting epidemiologic studies.Because IBC is rare, we needed to include a number of study hospitals and accrue patients over a relatively long period of time. This posed challenges with regard to standardization of study procedures over both space and time. We selected study sites for the case–control study based on existing relationships with investigators at various study sites, infrastructure for patient recruitment and conducting clinical and epidemiologic studies –9, interIncreasing number of participating hospitals in each country required adjustment of the study procedures to suit each hospital situation without compromising the integrity of the study. For instance, case and control identification procedures had to be modified for each study hospital (to be described later). Ideally, it is logistically easiest to recruit study subjects from as few study hospitals as possible to achieve sufficient sample size.http://www.nci.edu.e.g for the NCI-Cairo). Furthermore, new investigators can network with investigators who were funded to conduct studies in developing countries by searching databases such as the Reporter website of National Institute of Health (NIH) (http://projectreporter.nih.gov/reporter.cfm) or ongoing studies or publications of the International Agency for Research on Cancer (http://www.iarc.fr/).Investigators who intend to initiate a new study in middle- and low-income countries without prior contacts at study hospitals can research existing literature to identify centers with research experience. Some major cancer centers provide information on websites  or to a CD. Clinical information and digital photographs of the breast are then entered into the NIH National Library of Medicine Interaction Tool for review by outside experts. Each reviewer performs the evaluations through the Internet using a unique username and password. The results of their evaluations are saved in a central database.In many major hospitals in developing countries, including our study cancer centers, clinics are busy with large numbers of patients. This number could be in the range of hundreds of patients/day –16.Our challenge was to identify a rare cancer type (IBC) before treatment from among many breast cancer cases and other types of cancers. This challenge is not unique to the study of IBC, but would be present at most hospitals that do not have specific clinics for certain types of cancers/diseases. We found it critical to understand the patient flow at each study hospital. Thus, we sought to determine (1) the department in which suspected breast cancer cases were first seen; (2) whether suspected breast cancer cases were seen in a different clinic/room in that department than previously diagnosed cases; (3) in which department/room breast cancer cases diagnosed elsewhere were first seen; (4) how newly diagnosed cases were referred for treatment; (5) the number and schedules of physicians in the surgery and medical oncology departments; (6) the level of cooperation between the surgery and medical oncology departments; (7) whether free-of-charge patients, those with insurance, or those paying out of pocket were seen in the same clinics; (8) whether the hospital had a central review committee that evaluated all new breast cancer cases; (9) whether logs (paper or electronic) of patients, including diagnosis, age, and residence, were kept in the surgery and medical oncology departments; (10) whether senior physicians worked on a full-time basis or divided their time between their government or University hospital work and private practice; (11) whether the same residents staffed the clinics every day; (12) whether treatment was done on an inpatient/outpatient basis; and (13) the length of time between diagnosis and the start of treatment.We found this evaluation absolutely necessary and adapted our methods for identifying IBC cases to the existing procedures at each study hospital. For instance, at study hospitals that had a central review committee, we identified a study collaborator who attended the meetings to identify IBC cases. For study hospitals that did not have a central review committee, we followed two procedures: (1) we identified study collaborators who were available in the clinics for enrollment of IBC cases and (2) we asked study collaborators to notify clinic physicians who were not collaborators to refer IBC cases to study collaborators. We also sought to have multiple points of referral of IBC cases to study collaborators .We found it particularly helpful to include junior physicians in the study, particularly at institutions that had little rotation among the junior physicians. Linking the study objectives to the physicians' theses and dissertation topics and providing educational opportunities for them such as attending scientific conferences in North Africa or the United States motivated them to continue their contributions to the study.We found the following issues particularly challenging with regard to enrollment of all eligible cases: (1) adequate backup duration absences of study collaborators due to vacations, meetings, illness, or periods of study for examinations; (2) short rotations in the medical oncology departments for junior physicians at certain study sites; (3) the heavy schedule of senior study collaborators; and (4) changing hospital procedures that would interfere with study procedures for accrual. Therefore, we highly recommend that any study have procedures for review of medical records to ascertain the completeness of case accrual.In some types of studies, one may want to sample a certain type of cancer rather than recruit every case. This was the case for the non-IBC comparison group in our IBC study. With regard to comparison non-IBC breast cancers, the challenge was to select a sample from large pools of cases. Our methods for selecting non-IBC cases were also based on the careful evaluation of hospital procedures that we described above and varied depending on the hospital. We used logs kept by the surgery and medical oncology departments when available to identify non-IBC cases matching the IBC case within 5-year age groups and broad geographic area of residence. In other hospitals, we selected non-IBC cases from cases reviewed at weekly committee meetings. Finally, at some study sites, we randomly selected clinics from which to find matching non-IBC cases. To do this, we assigned a number to each clinic from which non-IBC cases could be selected and then used a simple SAS random number algorithm to randomize the assigned clinic numbers to determine from which clinic each non-IBC case was to be selected. If more breast cancer cases were seen at one clinic compared with another , we assigned numbers to the clinics in proportion to the number of cases they saw. Depending on the level of cooperation between the surgery and medical oncology departments, we selected non-IBC cases before or after mastectomy.The determination of the clinic from which each non-IBC case was to be selected was done at the NCI-USA and was communicated to the study collaborators as described in the section “Logistics of study implementation.” We ascertained from questions on our forms whether collaborators were adhering to the randomization scheme.We did not select population-based controls because we were not assured that our cases were population based. Furthermore, it would not have been feasible to select population-based controls because such things as telephone use and driver's license registration are very incomplete in the areas where our study is being conducted. We also faced additional challenges in recruiting controls. We could not recruit noncancer controls from our study patient populations because most sites were cancer centers. Noncancer hospital-based controls were not feasible because we would have had to enlist the cooperation of nearby general hospitals, thereby greatly increasing the complexity of the study. Therefore, we chose to select controls from those visiting certain types of other cancer patients at our study hospitals, as has been done in other studies –21. To dParticular challenges with selection of controls included (1) finding interviewers who were available during visiting hours; (2) finding visitors meeting the matching criteria for age and geographic residence; and (3) convincing the study collaborators that recruiting controls was as important as recruiting cases. Many clinicians have experience with research that involves cases but no controls.As noted previously, our study was low-budget and therefore, necessarily low-technology. Therefore, we used simple methods for study implementation. As noted previously, the hospitals that participated in this study saw a high volume of patients and were crowded and busy. In this setting, management of study documents to ensure completion of all required steps and to minimize loss of study materials is very important. Thus, we included all study materials for each study subject in an inexpensive 1-inch three-ring plastic binder with study documents in the order in which they were to be administered and dividers indicating who was to administer the study documents. Instructions were placed at the beginning of the binder. Forms included selection forms for visitor controls, eligibility forms for IBC and non-IBC cases, consent forms, the questionnaire, clinical examination forms, medical record review forms, pathology report forms, instructions for saliva collection and anthropometric measurements, and taking digital photographs. We designed selection and eligibility forms to record nonresponse, which is crucial to report for publication and for understanding whether the subjects enrolled in the study reflect the populations of interest. For instance, if visitors were eligible but refused, this was recorded on the visitor selection form. If IBC or non-IBC cases were eligible, but refused, this was recorded on the eligibility forms. A plastic pencil case was placed at the beginning of the binder to hold the vials for saliva collection. Labels identifying the study hospital, the type of study subject, the study ID number, the age category, and broad geographic area of residence for matching were placed on the cover of the binders. For non-IBC cases and visitors, the clinic or ward from which the study subject was to be selected was also identified on a label placed on the cover of the binder. Each subject type  had a different color binder. These binders were assembled in the United States and shipped to study hospitals. To facilitate the shipping of the binders, we completed an NIH 1884-1 Commercial Invoice form that allowed delivery of the binders directly to the study hospitals. Without this form, study collaborators had to pick up the binders at the customs office. On occasion, we have had some difficulty getting the saliva vials through customs in the collaborating countries. In fact, at some sites it became necessary to hand carry saliva vials during travel by U.S. study collaborators to avoid problems with customs.With regard to response rates, particular challenges included persuading clinicians that it was important to record nonresponse. It was also challenging to design forms that recorded nonresponse of eligible subjects but not nonresponse of ineligible study subjects.Data keying was done at the study sites using Viking Data Keying Software, a straightforward, well-documented commercial system. The double-keyed data files are uploaded to the study portal at the study sites and are then downloaded from the portal and merged into SAS datasets in the United States.In addition to being used for posting keyed data files and photographs, the study portal is also used to post all the documents for the study and to provide links for Institutional Review Board (IRB) and Federal-Wide Assurance (FWA) Registration.The design of clinical forms and medical review forms was developed in collaboration with the local clinicians in each site. The clinicians' input was extremely helpful in developing user-friendly forms that capture all the needed clinical information.Design of the epidemiologic questionnaire was challenging because the study is in three countries, with patients coming from both rural and urban areas. To accurately capture information related to socioeconomic status, education, occupation, contraception, childbearing, and breastfeeding in the different study populations, we talked extensively to study collaborators and used data from national surveys and other publications to help in determining questionnaire content. Important resources in questionnaire development included the following: (1) Egypt demographic and health survey 2005 ; (2) SocCultural sensitivity in developing the questionnaires, setting up the order of questions, and developing questions for sensitive issues was very important. For example, we learned that we should not start the questionnaire by asking about some demographic information of patients. We were told that starting the epidemiologic questionnaire with the demographic section will sound like a “police interrogation” of subjects. In our study, we included address, contact information, or relatives to be contacted in the future, if needed, age, place of birth, and marital history in the beginning but household conditions and appliances farther back in the questionnaire. It should be noted that the order of questions is culture specific, and it should be considered based on the local culture, preference, and settings in each country or region. As an example of a culturally sensitive topic, we were interested in including questions about subjects' exposure to mice in the household environment. We were advised by the local clinicians to tailor the sets of questions on this topic in an indirect way because it would be considered insulting to ask about mice in the household. We were advised to begin by first asking about subjects' knowledge of mice control campaigns in their neighborhood, followed by asking about their knowledge of mice in neighbors' homes, and finally asking about their use of rodenticides for killing mice in their homes. We also tried to be culturally sensitive to perceptions about cancer. For instance, local clinicians told us that some women refer to breast cancer as the “bad” disease of the breast, call malignant tumors “female” and benign tumors “male,” and refer to cancer hospitals as “bad” hospitals. We pilot tested the questionnaire with employees of the study hospitals from a variety of backgrounds.Study subjects were administered the questionnaires by interviewers. Although patients and physicians in the Egypt, Tunisia, and Morocco all speak Arabic, different dialects of Arabic are spoken in each country . Some TuThe final version of the questionnaire included the following sections in this order: contact information; age; religion; ethnic background; childbirth history; educational background of study subject; marital status; husband's educational and occupational background; menstrual history; contraceptive history, infertility, and menopausal hormonal use; breastfeeding history; medical history; family history of breast cancer; agricultural history; other occupational history; anthropometry; exposure to tobacco smoke; residential history and household appliances as surrogates for income; access to health care; level of cooperation in the interview; and current body measurements. The order of the above-listed sections of the questionnaire yielded the best flow of delivering the questions and cooperation of study subjects as shown in the pilot testing of questionnaires.For some study subjects, the questionnaire, which on average took 45–60 min, seemed long and interviewers had to give them breaks in order to complete the entire questionnaire. Some patients have difficulty in recalling age at childbirth, age at starting and stopping contraceptive use, age of starting different agricultural occupations, and exact weight at different ages. To help recall of ages at childbirth, we also obtained information on the current ages of the children, so that we could subtract the current age of the children from the study subject's current age to obtain the study subject's age at the birth of each of her children. The interviewers reminded the subjects of their childbirth history to help them recall their periods of contraceptive use. They used age of marriage and other major life events to help them recall ages of different agricultural and other occupations. With regard to weight, the questionnaire also included a diagram of body types at different ages, which the study subjects were able to complete. We also measured current body weight, height, and hip, waist, and chest circumference. Gender of the interviewer was also important. In one study hospital, the only interviewer available was male, and he was uncomfortable asking about bra size and taking chest and hip measurements. To compensate for this, the study clinician asked these questions and took the measurements.Medical examination and review forms were in English in Egypt because English is the medical language of medical education. French was the language of the same forms in Tunisia and Morocco. Translation of questionnaires into spoken Arabic dialects was challenging because most professional translators are comfortable with translation into standard Arabic, not into spoken colloquial Arabic. This resulted in considerable review and revision and back-translation of the translated documents. A possible alternative would have been to have the questionnaires in standard Arabic and to have the interviewers translate orally into spoken Arabic dialects, but this would have resulted in less standardization of the spoken dialects.Consenting is also a subject that should be considered with care in developing countries. The reasons include the large percent of illiterate patients who cannot read and sign the consent form. In addition, because of the need for free medical care, some patients may have the impression that they might not receive medical care if they do not participate in research studies. We had to be very explicit in the wording of the consent forms to avoid this possible impression. We had to have a witness sign the consent form after its verbal reading to each study participant who could not read or write. Witnesses were typically family members and that facilitated the consenting process and the high response rate of participation in the study. On some occasions, the husbands of potential study subjects refused to allow their wives to participate in the study even though the wives wanted to do so. In other middle- and low-income countries, the effect of the relationship with the witnesses needs to be investigated on consenting and study participation. Patients were asked to consent on each section of the study .We encountered the following issues in obtaining paraffin-embedded tumor tissue specimens: (1) ensuring that the method of formalin fixation is adequate to obtain viable DNA; (2) obtaining sufficient tumor tissue using the standard diagnostic techniques in the study hospitals; (3) obtaining tumor tissue for cases diagnosed outside the study hospitals; and (4) reluctance of collaborators to share their paraffin blocks for research outside the home country.We addressed the appropriate method of fixation by providing the standard protocol for preparing paraffin blocks that we used at the University of Texas M. D. Anderson Cancer center in the late 1990s. There were few differences between the M. D. Anderson protocol and the local protocols except that the latter used concentrated formalin for preserving the tissues after resection and possibly long duration (1–2 days) between resection and processing. Our M. D. Anderson protocol used 10% formalin and a processing of specimens within 3–4 h. We were able to persuade the local institutions to follow the U.S. protocol because all it required was dilution of the formalin with water without any expenditure of money or other resources. With the U.S. protocol, we were able to obtain viable tissues that we used in our subsequent studies , 35–37.With regard to obtaining sufficient tumor tissue, it is critical to determine what diagnostic techniques are standard in study hospitals. For instance, diagnosis of breast cancer, including IBC, is frequently done by fine needle aspiration, but this method does not yield sufficient tissue for research purposes. A true cut biopsy is more likely to yield sufficient tumor tissue, although yield might not always be enough and is less than is obtained from mastectomy specimens. Because a true cut biopsy also has advantages in terms of diagnosis, our collaborating clinicians agreed to do true cut biopsies instead of fine needle aspiration biopsies to accommodate the research study.With regard to obtaining tumor tissue for cases diagnosed outside the study hospitals, we note that it is often customary for patients to bring their slides from the diagnosing hospital or pathology laboratory to the study hospital. Personal communication of the study clinicians and pathologists with the hospital or laboratory where the biopsy was done is extremely important for having a complete set of tissues. Many tissues that were diagnosed outside our collaborating cancer centers were processed at private laboratories of the institutions' pathologists and were prepared according to our study protocols.It is important to do periodic checks of the quality of DNA from the tissues obtained from the collaborating cancer hospital or private laboratories to ensure high quality. Pathological diagnosis is always confirmed by our collaborating pathologists in North Africa and the United States. Embedding of tissues in cassettes varied between the collaborating institutions and sometimes needed re-embedding in the United States if tissues are directly fixed on paraffin without cassettes. Relying on bar-coding of specimens in developing countries should not be selected as an option because of lack of scanners and computers that would download and read scanned numbers. Instead, it would be useful to scan and print IDs before shipping forms and labeling tissues and slides after they are received in the United States.Regarding the reluctance of collaborators to share their patients' paraffin blocks outside the country, this was mainly due to country rules on exporting biologic specimens or their interest in local technology transfer to their country. We understood the country restrictions on exporting tissue blocks and instead we obtained cut tissue slides instead of paraffin blocks. When technology transfer was the issue, we followed three approaches: (a) we developed tissue microarrays in the United States and shared duplicates with the local collaborators; (b) we supplied the local collaborators with reagents to perform the laboratory assays locally and compared the quality with the U.S.-generated results from the same specimens; or (c) we provided training to the local collaborators in the United States to return back to their home countries to perform the laboratory assays.Obtaining saliva samples is being accomplished using Oragene saliva collection kits, which can be stored at room temperature for years, require no special preparation or handling, and are easy to use by study subjects, for the most part. The only precautions for saliva collection are the need for the subject to avoid drinking, eating, or chewing gum for 30 min before spitting and the possible expiration of the reagent included in the saliva tubes for preservation, if the tubes are kept past their shelf life.http://www.cdc.gov/od/eaipp/faq.htm. Etiologic Agent Import Permits are not required for the transport into the United States of noninfectious materials – for example, formalin-fixed specimens, tissues, or slides, and human or animal diagnostic specimens such as blood, urine, and tissues in which there is no evidence or indication that such material contain an infectious agent. However, the following recommendation is taken directly from the CDC website: CDC advises that importers of materials that do not require a CDC import permit include a signed statement, on their official letterhead, from the person responsible for the shipment of this material with the following information:Regulations regarding the import of biologic samples into the United States can be found at the following website: a description of the material;a statement that this material meets one of the above criteria ; andverification that the material has been packaged, labeled, and transported in accordance with all applicable regulations.We tried group training of interviewers and study coordinators at one of the collaborating sites in North Africa, but the efficiency of this training was lower than our site visits to individual hospitals and sites. For instance, visa issues and agreeing on one place and time period where the collaborators leave their routine hospital work were limiting factors for the effectiveness of the group training.Students from the University of Michigan School of Public Health and Cancer Center also help in monitoring the study. They conduct summer research projects funded by the NCI through an R25 educational grant and the University of Michigan research and training grants. The students travel to monitor the study, train local collaborators, and streamline unresolved issues. Involving students was very helpful in facilitating IRB, questionnaire design, testing the questionnaire, and monitoring the study and their research resulted in several publications –44. For Involvement of students was a useful research experience for them in international epidemiology and facilitated the field study.In addition, the University of Michigan in collaboration with the Office of International Affairs of NCI has sponsored the University of Michigan Graduate Summer Courses in cancer epidemiology and translation of epidemiology to cancer prevention and control. Several of our collaborating clinicians from North Africa have participated in these courses and the exchange of knowledge and experience improved their engagement in the study and understanding of epidemiologic methods and applications to cancer prevention.We used simple EXCEL files for study management in the United States and at some study sites. Other sites used paper study management systems because computer access was difficult. Low-technology study management procedures were more successful because of lack of high-efficiency computer systems, available high-speed Internet, and absence of other advanced technological procedures such as wireless Internet connection, remote access of computers, and institutional servers with automatic backups that are increasingly becoming routine in U.S.-based research studies. In fact, home availability of the Internet in Egypt and Tunisia ranges between 25% and 40% . While ihttp://www.hhs.gov. Ethical guidelines for international studies can also be found in the book “International Ethical Guidelines for Epidemiologic Studies” from the Council for International Organizations of Medical Sciences (CIOMS) studies. We note that the Health Insurance Portability and Accountability Act of 1996 (HIPAA) does not pertain to institutions in low- and middle-income countries.For an international multicenter study like ours, with inclusion of a U.S. Federal Government funding component, the regulatory requirements that had to be met were many. These included approvals from IRB at sites in the United States and in the collaborating countries, FWA registration for all collaborating institutions, and payment . While these approvals and certifications are routine procedures for researchers in the United States, they were a challenging experience for our international collaborators. Issues were (1) lapsed IRB and FWA registrations at some study sites; (2) disbanded IRB committees that had to be reconstituted according to U.S. regulations; (3) complicated registration instructions that were not in the native language of the study collaborators; (4) intimidating legal language; (5) difficulty in remembering passwords and access codes to the electronic websites; (6) poor computer access; (7) signatory officials who were not part of the research team; and (8) registrations lapsing during the course of the study because not all collaborators routinely check e-mails, thus missing notifications that registrations needed to be renewed. We had to walk the collaborators through the certification process through numerous emails and site visits. At some sites, we also found that IRB committees did not meet until they had a sufficient number of protocols to review. Thus, plenty of time should be allowed to accomplish these registrations. U.S. collaborators should make every effort to be cognizant of registration lapse dates. Information on U.S. Government regulations regarding IRBs and FWAs can be found at the following address: The system of invoicing to the NCI and reimbursement after provision of the service of recruitment was a new concept for our international collaborators. It is important to note that our payment system was based on recruitment of triplet sets of IBC, non-IBC, and control subjects. This payment system for studies in developing countries is significantly more efficient than payment on percent salary effort or monthly basis as is the case in the United States. Because of low salary levels in developing countries, the percent effort compensation does not work there.In the current era of global and international health, political circumstances are an integral part of the dynamics of joint research and international collaborations. The changing politics in the Middle East starting from the Iraq war in 2003, which delayed the start of the study, and the revolutions in Egypt and Tunisia in 2011, which slowed the flow of patients to study hospitals due to security concerns, have had their impact on the pace of the research study. In fact, we had to extend our contracts to the study sites to account for accrual over a longer period of time.Other logistical points to consider include understanding the hierarchy and internal politics of the collaborating institutions, the importance of inclusion of senior, mid-career, and junior collaborators, understanding the system of retirement for senior collaborators, and finding opportunities for motivating clinicians to collaborate on an epidemiologic study by including aspects related to clinical research, financial incentives, and other opportunities for professional growth, such as authorship on manuscripts or training in epidemiology. For instance, some of our clinician collaborators were interested in measuring breast size from mammograms, so we incorporated questions about this in our medical record review form. Other clinician collaborators are participating in a clinical trial of IBC during the same period of time as the epidemiologic study, which increased interest and motivation. We further funded training of several collaborators at short epidemiology courses conducted in the Mideast by the first author of this article.We attempted to measure breast size in two ways: by obtaining information on bra size on the questionnaire and by recording certain measurements from the mammograms . However, our efforts were not entirely successful because women living in rural areas frequently do not wear bras. Moreover, the physicians were not used to making the measurements on the mammograms so these measurements were rarely made. Successful implementation of the mammographic approach would require more extensive training than we did. Breast immersion and measuring the volume of water replaced were impractical in a routine hospital setting. Developing new feasible and practical methods for estimating breast size would be important for epidemiologic studies of breast cancer considering the wide range of variation in breast size between populations.Our study would have benefited from more frequent and longer site visits by U.S. principal investigators. In general, we had funding to do two site visits per year, with 1–3 days at each study site. It would have been helpful to have four site visits per year, with a minimum of 2 days at each site. Students were funded for a period of 3–4 months, the limit allowed by the training grant and their class schedules. Additional funding for more extended stays and more flexible and tailored curriculum of students would have enabled them to stay longer at each site.Regular use of advanced tools of electronic communication with the collaborators in North Africa would be helpful. Currently, there are software programs such as Adobe Connect that enable verbal and visual communication and sharing and editing of documents between collaborators at different international locations. Use of these techniques would enhance effective communication at limited cost.Diagnostic criteria for cancers other than IBC, such as hematologic malignancies, may differ among countries. Therefore, teaching sessions by expert pathologists should be included in the studies of such cancers in order to minimize diagnostic differences among study sites. Studies of cancers that require diagnostic imaging  might require upgrading the infrastructure of the recruiting hospital and physician training to capture the cases.We have summarized our recommendations for the planning and conduct of epidemiologic studies in low- and middle-income countries in a checklist .Our experience in conducting this epidemiologic study in North Africa highlights the importance of the some general points for those interested in future epidemiologic case–control studies in North Africa and other middle- or low-income developing countries.It is very important to understand the healthcare system of the country and the cultural and behavioral factors related to seeking medical care. This includes understanding the referral patterns of cases to study hospitals. This information is crucial for efficient recruitment, selection of an appropriate control group, and generalization of the results. For instance, if many cases of the disease of interest never seek health care, it is not recommended that population-based controls be used.In selecting a control group, it is also very important to understand the culture of the country. For instance, if telephone use and driver's license registration are very incomplete in the areas where the study is going to be conducted, certain methods for selecting controls, such as random digit dialing, are not recommended.Defining the precise clinical and/or pathological nature of the disease to be studied is essential and may vary by the cancer site/type to be studied. For example, precise clinical diagnosis is the most important diagnostic element for IBC. On the other hand, precise pathological and/or immunological diagnosis is the most important element for inclusion of lymphoma cases in epidemiologic studies.Epidemiologic studies should consider the inclusion of clinical components and/or coordinate with clinical trials of the same disease that might be underway in study hospitals. This point is especially important because of the limited number of trained cancer epidemiologists in developing countries and the leadership of research studies by clinicians. In the meantime, training and creation of a new cadre of trained cancer epidemiologists is also important.Readiness for unexpected changes in the pace of the study due to political, personnel, or hospital setting changes is crucial. Alternative plans should be considered and be available for continuation of the study under new circumstances.It is important to explore all avenues for funding and training of junior clinicians, study managers, and interviewers. Sending collaborators to short courses in cancer epidemiology, offering training options in the United States, and inclusion of students from the United States into the study are very helpful. Coupling of local and U.S. students can also add many benefits to the progress and quality control of the study.It is also important to appreciate technical difficulties, busy clinics, and overloaded local systems for patient care in developing countries. It is important to consider reliance on low-technology methods for data management, quality checking, and monitoring of the study rather than high-technology sophisticated software system that require high-speed Internet and other technology that might not be regularly available in hospital settings.It is important to know that there are likely unwritten cultural codes in middle- and low-income countries and their hospitals. For instance, internal conflicts between departments and fear of displeasing mentors or powerful institutional leaders may constitute unwritten codes that hinder the progress of the study. It should be noted that understanding such conflicts may need time and close engagement with the collaborators. In some middle- and low-income countries, the primary income of cancer center faculty will be earned in their private practice. Sometimes, their service at the university will be unpaid. Consequently, university department chairs, deans, and administrators might have little power to influence their faculty members, and this can come as a surprise to researchers from high-income countries. Therefore, it is important to consider whether a particular collaborator should be compensated with financial incentives separately from the grant budget that is allocated for the cancer center or through other means. Private discussions must resolve these matters. Other unwritten codes include the difficulty and misunderstanding of spoken English. Furthermore, “yes” does not always means “yes” and “no” does not always mean “no.” There are also many cultural barriers that may prevent collaborators from expressing their disagreement. For example, researchers and clinicians may feel embarrassed to inform their collaborators from high-income countries of their disagreement about a study procedure or feasibility of success of a study procedure. The result will be a false impression of agreement while failure of achievement will be the outcome. On the other hand, researchers and clinicians may show rejection of certain study procedures or techniques because of their lack of knowledge of this procedure or its implementation. Because they may feel that they may be displeasing the collaborators from high-income countries if they admit so, they may reject the procedure rather than learning about it.We expect that there will be many overlapping points between our experience on the epidemiology of IBC in North Africa and other research studies on breast or other cancers in other middle- or low-income developing countries. Possible variations between our experience and future research studies include the level of development of the country, study design, cancer site, cultural and behavioral factors of populations, access to medical care, referral systems of patients, and the medical education of the country. While we attempted to maximize the success of our study using the methods described in this article, other study- and region-specific measures may be tailored according to the aims and local circumstances of the study setting to enhance opportunities of success.


Chlamydia trachomatis bacterial infection, a common cause of infertility, are highly prevalent in developed countries, and a worrying problem in North Norway, where the incidence of chlamydia twice the Norwegian average. Seventy percent of reported chlamydia cases are found in people below 25 years of age, and although its spread could be controlled with proper prevention, young people are more aware of the risks of unwanted pregnancy than their risk of acquiring a STD. Information and Communication Technologies, including, the Internet, social media and/or smartphones, should be valued for sexual health promotion for their potential to engage young audiences. And in these media, avatars guarantee anonymity to users when handling sensitive information. The main objective of this project is to achieve that North Norwegian youngsters become more aware of STDs through the use of popular technologies among young people.Sexually transmitted diseases (STDs), especially the A Virtual Clinic for Sexually Transmitted Diseases (VCSTD) will be developed. The VCSTD will provide early guidance and reliable information sources concerning reproductive health, delivered in a novel and innovative way to the younger population. The VCSTD consists of an “avatar” supported intervention in a serious gaming and e-learning environment, which will bypass direct physical access (in person) to reliable medical information, as well as allowing the youngsters to share that information in social media, and thus helping the VCSTD to be disseminated to more people.Data analyses will be conducted on publically available health data relevant to STDs in Troms and Finnmark, like the absolute number of chlamydia tests, the amount of emergency contraception medication sold, and the number of abortions. Also, usage data of the system and experiences of usefulness will be explored through participants’ voluntary responses to a feedback form available in the VCSTD.This study will examine the usefulness of an online public health intervention that aims to promote healthy sexual practices among North-Norwegian youngsters. If shown to be effective, the intervention could prove to be an affordable and widely accessible intervention to decrease risky sexual practices in younger population. It is well known that a young age at the first experience of intercourse, a poor condom use and an increase in the number of lifetime sexual partners favour the transmission of sexually transmitted diseases (STDs) , with poChlamydia trachomatis infection (hereafter referred to as "chlamydia") are diagnosed worldwide [Every year, approximately 90 million new cases of genital rldwide ; and thirldwide . The mosrldwide , pelvic rldwide .Chlamydia, with a mean incidence rate of 467 cases per 100.000 inhabitants in 2009  have hadnd quarter 2011 found that 100% of youth from 16 to 24 years old had been using Internet in last 3 months, 93% of them use Internet every day or almost every day; and 96% of activities on Internet were related with social networks, as Facebook, Twitter, etc [Young people generally lack knowledge about sexually transmitted diseases and are more aware of the risks of unwanted pregnancy than their risk of acquiring a STD . In viewThe use of ICT related with sexually transmitted diseases has been studied during last recent years ,12. Now A more recent study with young people aged 15 to 24 from Vancouver found that, in general, youth (age<25) are particularly receptive to internet-based services [Interestingly, evidence also suggests that certain health behaviours might spread through social ties, of which online social networks are one example. Social network analysis is therefore regarded as a promising, new field for monitoring the spread of STDs, and for development of new interventions for STD control. Actually, online social networking sites, like Facebook, Twitter, MySpace, LinkedIn, etc.… are being used for sexual health promotion , but desThe use of social media in health promotion therefore be valued for their potential to engage with young audiences; in fact, a recent study concluded that more than 50% of the teenagers disclosed information about health risk behaviours in social media public profiles like MySpace . ConsequAvatars, also known as player or game characters, are defined in computing terms as the graphical representation of a user. But in psychological terms represents much more: gives anonymity and freedom to users (facilitating their access to sensitive information) and at same time represents an opportunity for changing the behaviour of users  due to iRelated to the behaviour of users when defining the characteristics of the avatars, while some authors have been analysing the importance of realism and interactivity of avatars in terms of behaviour and form on e-learning environments -24 otherStudies have shown that people infer their expected behaviours and attitudes from observing their avatar’s appearance, this phenomenon is known as the Proteus effect . These sThe main objective of this project is to achieve that North Norwegian youngsters become more aware of STDs through the use of popular technologies among young people.http://www.sjekkdeg.no, will provide early guidance and reliable information sources concerning reproductive health, delivered in a novel and innovative way to the younger population. The VCSTD consists of an “avatar” supported intervention in a serious gaming like and e-learning environment, which will bypass direct physical access (in person) to reliable medical information, as well as allowing the youngsters to share that information in social media, and thus helping the VCSTD to be disseminated to more people.To achieve the main objective a Virtual Clinic for Sexually Transmitted Diseases (VCSTD) will be developed. The VCSTD, which will be hosted at The VCSTD will be developed under the premise that Information and Communication Technology may empower younger citizens to change their health related behaviour and lifestyle. ICT supported, health related tasks such as seeking medical information could have a large effect in the reduction of costs and also allow reaching more people to provide behavioural intervention and support at less financial and personnel costs . The VCSThe VCSTD it is expected to start at the end of August 2012.Youngsters from the two northernmost regions in Norway, Troms and Finnmark are expected to participate in this project. But due to the VCSTD project will be disseminated through Facebook and users could share it in the social media, participants from other parts of Norway could be found, or even Norwegian-speakers from/in other countries.Upon registration, which consists of creating an avatar , the participant will receive a web unique link which enable him/her to access the secured web and to enter data. To access the VCSTD the user has two possibilities: 1. Login by writing the username and password, 2. Clicking on the link and writing the password. If the user needs to recover his/her avatar web link and or password, the combination of giving the username and answering the secret question can be used.Then, users could enter into the virtual clinic after choosing an avatar to represent them anonymously. Inside the clinic they will have access to a set of reproductive health resources such as videos, articles, audio, quizzes and links. Each participant will be asked to interact more than one time, although every created avatar from an IP belonging to one of the two northernmost regions (Troms or Finnmark) will be analysed.Norsk Dermatologisk Selskaps).Both, the avatar and the provided data will be voluntarily entered by each participant and will be stored in their own profile. The stored information will consist in different quizzes about his/her knowledge on STD and how to prevent it (eg. “How much I know about Chlamydia”). Other collected information will be the answers on a symptom check list , while recruitment channel 2 will be targeting traditional venues for public health recruitment . Recruitment to the VCSTD will be aimed specifically at the two northernmost regions in Norway. This will include utilization of social media/networks. The trial will run one year from start-up.Due to the nature of the project identifying individual participants will not be possible. Data analyses will therefore be conducted on publically available health data relevant to STDs in Troms and Finnmark: 1) Absolute number of chlamydia tests; 2) Amount of emergency contraception medication sold ; and 3) Number of abortions.Also, experiences of usefulness will be explored through participants’ voluntary responses to a feedback form available in the VCSTD. The usage data of the system will be also used to evaluate the usability of the system (average time spent in the system by the users).adhoc and anonymous questionnaires to assess how the site has affected their knowledge on sexual health, STD and specifically Chlamydia, and possibly their behaviour change, and/or motivation to test themselves for STDs.Users of the VCSTD will be issued with an invitation to answer voluntarily one or more Users could be asked also to answer voluntarily and anonymous short personality inventories, like the Sensation-Seeking Scale  or the LA review of the project at the Regional committee for medical and health research ethics (REK Nord) is not applicable as patients are not involved in the research, and all health data investigated are anonymous.adhoc questionnaires about the site and how it has affected their knowledge will be analysed using qualitative techniques.The purpose of the study is descriptive, so the results will be expressed in form of frequencies and percentages for each categorical variables and mean, standard deviation (SD) and 95% confidence interval (95% CI) for continuous variables. T-Tests, ANOVA, correlation and Chi-Square analyses will be performed as well. The opinions of users in the Quantitative data analysis will be performed with the SPSS statistical package version 19.This study will examine the usefulness of an online public health intervention avatars based and using computer/smartphone mediated communication and social networking in prevention of sexually transmitted diseases and healthier sexual practices among North-Norwegian youngsters.Considering that Norway has one of the highest Internet penetration rates in the world 97.2%)  and thes7.2%  anIf the VCSTD shown to be effective, the intervention could prove to be an affordable and widely accessible intervention to decrease risky sexual practices among the younger population.AIDS: Acquired immunodeficiency syndrome; ICT: Information and Communication Technology; STD: Sexually transmitted disease; VCSTD: Virtual clinic for sexually transmitted diseases.The authors declare that they have no competing interests.EG and JAS have contributed to conception and design, drafting and revising the manuscript critically for important intellectual content. RW and MA have contributed to conception, design and revising the manuscript critically for important intellectual content. All authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6947/12/120/prepub


Non-communicable diseases (NCD) and infectious chronic illnesses are recognised as significant contributing factors to the burden of disease globally, specifically in South Africa, yet clinical management is often poor. The involvement of community health workers (CHWs) in TB and HIV care in South Africa, and other low- and middle-income settings, suggests that they could make an important contribution in the management of NCDs.Using a rapid assessment, this study examines the outcomes of a pilot CHW programme to improve the management of hypertension and diabetes in Gauteng province, South Africa.A record review compared outcomes of patients receiving home visits (n56) with a control group (n168) attending the clinic, matched, as far as possible, on age, gender, and condition. Focus group discussions and semi-structured interviews with CHWs, patients, district, clinic, and NGO staff were used to obtain descriptions of the functioning of the programme and patient experiences.Despite the greater age and co-morbidity among those in the pilot programme, the findings suggest that control of hypertension was improved by CHW home visits in comparison to usual clinic care. However, too few doctor visits, insufficient monitoring of patient outcomes by clinic staff, and a poor procurement process for supplies required by the CHWs hampered the programme's activities.The role of CHWs in the management of hypertension should be given greater consideration, with larger studies being conducted to provide more robust evidence. Adequate training, supervision, and operational support will be required to ensure success of any CHW programme. Management of chronic illnesses in low- and middle-income countries is often poor with health systems struggling with an outward flow of human resources and insufficient funds –3. ThereThis study provides a rapid assessment of a CHW pilot programme in Emfuleni sub-district of Gauteng, South Africa, that aimed to improve the management of hypertension and diabetes. A description of the programme and the research objectives in the next section are followed by the research methods, findings, and a conclusion discussing the relevance of the findings for national and international policy.The Gauteng Provincial Department of Health South Africa in 2008 initiated the ‘Kgatelopele’ programme at one clinic in Emfuleni sub-district, in collaboration with Hands of Hope, a non-governmental organisation. The programme seeks to improve the management of hypertension and diabetes among patients by home delivery of medication and assessment of basic clinical indicators. Home visits by CHWs are intended to improve the accessibility, acceptability and affordability of health care, and strengthen the referral system between the community and health facilities. The CHWs provide social support and counselling to improve patient literacy and adherence, and to encourage appropriate visits to the PHC clinic. The clinic serves a population of 27,199, of whom 23,677 are un-insured, and hence use the public health sector. At the time of the study, patients enrolled on the Kgatelopele programme were visited once a month by one member of a team of six CHWs. A pharmacist packed a month's supply of medication for delivery to named patients. Patients are required to visit the clinic every 6 months for a physical examination by a doctor, who provides a renewed prescription. CHWs have attended a 14-week training course that focuses primarily on home-based care, other than providing skills in adherence counselling and health promotion, with a particular focus on chronic illnesses, including hypertension and diabetes. Other anticipated benefits of the programme included a reduction in clinic visits for elderly patients for whom there are physical challenges in attending the clinic, a reduction in transport cost for patients, and opportunities for CHWs to identify and refer other family members in need of health care. Hypertensive and diabetic patients not in the pilot programme attend the clinic on a monthly basis.The objectives of the study are to, first, provide a comparison of treatment outcomes to give some insights into how extension of care into the community may be developing; second, to describe the operational challenges of the programme; and finally, to draw lessons relevant to CHW programmes providing NCD care in other settings, both within South Africa and other low- and middle-income countries.We were asked by the Sedibeng district manager to conduct a rapid evaluation of the pilot CHW programme. The evaluation used a retrospective case study approach, employing both qualitative and quantitative methods. The study population consisted of individuals registered in the Kgatelopele programme (56 patients) in Emfuleni sub-district, Gauteng, as well as patients receiving usual clinic care at the same clinic. Interviews were conducted with 20 Kgatelopele patients on their experience of the programme. Seven key informants  were interviewed to obtain information on the training of CHW, supervision, procurement, and referral processes in addition to other elements of the programme operation and its challenges. Two focus group discussions were held with two groups of six CHWs to obtain a description of practical day-to-day functioning of the pilot and its challenges.A record review was undertaken, using a pre-designed record review form, of patients on the Kgatelopele programme and a control group comprising three clinic patients matched for condition, age, and gender for every Kgatelopele patient. The Kgatelopele programme enrolled stable patients, and a clinic patient was deemed a suitable match if, where possible, the person was within 5 years of age the Kgatelopele patient.With 56 patients in the intervention group and three-fold more controls, we would be able to detect a difference between groups if hypertension was controlled in 40% of intervention group and in 20% of controls, with 80% power  for at least >40% of clinic visits). There is little gain in power with having more than three-fold the number of participants in the control arm.The record review collected data for the year prior to the study on a number of variables, including age, sex, number of home visits, monthly measures of BP and blood glucose, doctor reviews, and clinic attendance. For this study, we took 110/60–130/85 mmHG as an acceptable range for controlled hypertension. We used 3.6–5.8 mmol/l as an acceptable range for controlled diabetes. The record review data were analysed by comparing the BP levels and glucose level (Hgt) (using a random sample) of patients on programme and comparison group.a priori and emergent themes. Respondent views that were divergent from common perspectives were explored further to ensure opposing views were retained within the analysis. Ethical approval was granted by the University of the Witwatersrand Committee for Research on Human Subjects. Informed consent was given by all respondents.Thematic analysis was conducted on interview and focus group discussion transcripts, identifying data on The sample consisted of 56 patients on the outreach programme and 168 clinic patients, with slightly more female patients than males in both groups . DespiteThe mean age of those on the programme was 75 years (range 54–96), and 69 years (range 51–92) in the clinic group. Nearly 40% of the programme patients had both hypertension and diabetes, in comparison to 25% in the clinic group. The mean number of months on treatment was nine (range 1–20) compared to 6 months (range 2–13) for clinic patients, and the mean number of months since enrolment on the programme was eight (range 2–18).For patients with hypertension, the condition was controlled for a higher proportion of patients on the Kgatelopele programme in comparison with those attending the clinic . 21.4% owith both conditions, hypertension was controlled amongst a considerably higher proportion of Kgatelopele patients  >40% of health checks in comparison with 4.8% of clinic patients (2/42).1If we consider only those With the problem of taxis and being old, this programme is helping by delivering my medication at home. (Patient)Study participants stated that the Kgatelopele programme had a positive impact on access to care: “Kgatelopele is helping many people and is saving many people's lives. So people in this area are getting help from it and they are happy with the program” (KII). In particular, the programme assisted elderly patients who had difficulties travelling to the clinic:The care giver who comes here always gives me advice on how to avoid high BP and sugar level. She told me that if I don't follow the advice it might cause me stroke. (Patient)Patients were also satisfied with the CHW counselling and health information:Patients are defaulting. They are not taking medication as they are directed. Medications are packed with written instructions but then the patient will not take some medication; they will choose (which pills to take). (KII – Clinic nurse)A variety of explanations were given for the overall poor levels of control of both conditions. Some patients explained they discontinued their medication because of side effects: staff confirmed this.The elderly respondents reported difficulty in attending the 6 monthly review (by a doctor) at the clinic due to the inability to walk to the public transport, or funds to pay for public transport. One key informant also reported: “Patients do not want to go see a nurse. When we tell the patients they must come to the clinic they say ‘You said I must come to see a doctor; so where is the doctor, not a nurse again’”. As a result, the patients’ prescriptions are not renewed and treatment is missed.It is good programme because our clinics are flooded with patients. Some of the patients really don't need to be at the clinic. (KII)An important benefit of the programme was the reduction in the patient load at the clinic:I don't think she (the doctor) understands what is happening really, even people who are very well who can come to the clinic, but I took them on the side and said no you are not going to be on the program, we are taking care of people who cannot come to the clinic, those who must hire the transport to the clinic because they are very sick. (KII)There were different views as to the criteria for enrolling patients on the programme, with some respondents stating that the programme should be for all chronic disease patients. Other respondents were of the view that younger, more mobile patients should come to the clinic, as they are often not at home when the CHW make visits.The first challenge is the availability of the doctor and this is the serious one. When I say the availability of the doctor I mean like now the last time she came here was 12th of August till today (19 October). So the patients who were supposed to be reviewed are not getting medication. (KII – District staff)However, an insufficient number of visits to the clinic by the rotating doctor increased the number of visits required to renew a prescription. The doctor was not available for the patient review as scheduled in 14% of cases.In addition, the insufficient number of doctor visits limited clinical supervision available for nurses.The [provincial Department of Health] gave us the bags and there's BP machine, sugar strips and everything but when those things are finished we (NGO) have to find the money . (KII – NGO staff)The interview data provided a limited explanation as to the differential effects on control of hypertension and diabetes. CHWs and NGO staff complained of shortages of glucose strips, which are likely to have hindered monthly monitoring of blood sugar levels, and efforts at self-management by patients. Lack of materials, a key to barrier effective functioning of the programme, was caused by a lack of dedicated funding and unclear procurement processes and responsibilities:No regular meetings among the NGO, clinic staff, and district staff were held to discuss issues such as shortages of CHW equipment, or funding constraints to purchase new supplies.I don't get time to communicate or sit with the NGO manager and discuss the work of CHWs or which patients were added. They could at least give me copy of papers where CHWs record test results for patients. (KII)CHW records provided descriptive data on activities, such as the number of patients seen, patients’ health complaints and dates for next visit. The information collected by the CHW was reported to supervisors at the NGO, who did not see it as their responsibility to intervene should a patient have poor clinical outcomes. Clinic nurses did not regularly examine the CHW records. As a result, they did not identify, or take action to assist patients that required intervention or referral.Systematic reviews have provided evidence of the efficacy of CHW programmes with respect to certain health service outcomes , in a range of different low- and middle-income settings . HoweverDespite concerns of adherence and problems with doctor availability, these findings suggest home delivery of medication and monitoring by CHWs (rather than nurses) did not worsen control of hypertension; instead the benefit of not having to travel to the clinic, as well as perhaps the care provided in the home setting, led to better control. The findings of this study suggest that the role of CHW in the management of hypertension should be given greater consideration, with larger studies being conducted to provide more robust evidence.However, the same was not true for diabetes, where the condition was better managed among clinic patients. Diabetes was controlled for 26% of patients at the clinic in comparison to 9% of the Kgatelopele patients. The explanation for this was unclear from the interviews. It may be due to insufficient training of CHW on assisting patients to manage diabetes (mentioned in the description of the programme), a condition that requires more active self-management by patients , or the Although the level of control for either condition was far from ideal, the findings were not dissimilar to other South African studies.  is lower than the international and South African standard 140/90 mmHg). Edwards et al.  . The finLack of support from the health system was evident in that the CHWs did not report their monthly clinical assessments of patients to the nurses. As a result, the information that was collected did not trigger an intervention for patients whose condition was not controlled. Moreover, too few doctor visits to the clinic prevented renewal of patient prescriptions and hence limited clinical oversight. Furthermore, poor procurement processes for required materials hampered programme activities. In addition, poverty and the associated social determinants of health, often result in barriers to care that CHW are unable to resolve without intervention from other sectors such as social welfare . Again tSouth Africa's antiretroviral treatment programme, the largest worldwide with recent notable increases in coverage, has generated substantial knowledge on how to improve adherence, tracing defaulters, and enabling patient participation through treatment literacy and patient support groups . It is iOutcomes of this pilot programme suggest that home visits and delivery of medication by CHWs can lead to improved control of hypertension in comparison to patients attending the public clinics on a monthly basis. However, this programme did not meet CHW training and supervision needs, or ensure effective procurement processes. Further efforts are required in this regard for CHW programmes to contribute successfully to improved management of NCD.


Knowledge management is a critical activity for any organization. It has been said to be a differentiating factor and an important source of competitiveness if this knowledge is constructed and shared among its members, thus creating a learning organization. Knowledge construction is critical for any collaborative organizational learning environment. Nowadays workers must perform knowledge creation tasks while in motion, not just in static physical locations; therefore it is also required that knowledge construction activities be performed in ubiquitous scenarios, and supported by mobile and pervasive computational systems. These knowledge creation systems should help people in or outside organizations convert their tacit knowledge into explicit knowledge, thus supporting the knowledge construction process. Therefore in our understanding, we consider highly relevant that undergraduate university students learn about the knowledge construction process supported by mobile and ubiquitous computing. This has been a little explored issue in this field. This paper presents the design, implementation, and an evaluation of a system called MCKC for Mobile Collaborative Knowledge Construction, supporting collaborative face-to-face tacit knowledge construction and sharing in ubiquitous scenarios. The MCKC system can be used by undergraduate students to learn how to construct knowledge, allowing them anytime and anywhere to create, make explicit and share their knowledge with their co-learners, using visual metaphors, gestures and sketches to implement the human-computer interface of mobile devices (PDAs). Explicit knowledge is systematized and standardized, and can be expressed by a formal language. Tacit knowledge is acquired by people through verbal face-to-face conversations, exchange of personal experiences or by their own intelligence. Tacit knowledge resides in someone's mind and it is difficult to externalize because it is not structured enough ,2; it nei.e., in ubiquitous environments [Much of the literature about KM systems addresses issues such as how to facilitate the creation, storage, and transfer of explicit knowledge . By theironments ,10,12,13etc., are suitable and helpful for supporting and facilitating various communication and interaction processes among users requiring to perform face-to-face meetings and/or requiring computational support when being on the move in order to give continuity to their work when moving from one place to another [Mobile workers often have spontaneous face-to-face meeting anywhere and anytime which are nowadays considered critical activities in any organization. In these meetings they develop processes involving social interaction, communication and mutual trust that yield to explicit and tacit knowledge creation . It has  another ,12. The  another .etc.) but there is still no evidence in the literature, nor curricula description, of pedagogical practices supporting the learning of the mentioned topic in an ubiquitous learning scenario, nor the usage of mobile devices in these situations.Learning how to create and share knowledge by converting tacit into explicit knowledge, is not an easy task although it is part of the learning program of various courses associated to business school curricula, given the importance of this topic in relation to management of organizations and the value of the intellectual capital of its members. To our knowledge, the pedagogical practices applied so far are varied  as technological support for this kind of ubiquitous meetings, providing simple but helpful visual mechanisms to support knowledge construction, especially targeted for tacit to explicit knowledge construction . The resThe system's design takes into consideration empirical and experimental researches on the KC process and the tacit and explicit knowledge management, including: (a) recommendations about the role of information visualization mechanisms and using gestures and sketches as the main human-computer interaction paradigm with mobile devices having touch-screen in order to easily interact with the system and raise the productivity (Section 2.1); (b) results of researchers about the loss of productivity in the generation of ideas, like free-riding, production blocking, and evaluation apprehension, (Section 2.2); (c) the SECI knowledge transformation model ,9,14  highlig2.2.Most people believe that knowledge construction is best performed in face-to-face groups ,19. Howe2.3.Knowledge construction is a social, collaborative, and dynamic process transforming tacit into explicit knowledge ,20–22. INonaka's SECI model ,23, inclNonaka and Toyama , develop2.4.The SECI model of knowledge creation was applied in two operational models for facilitating the dynamic creation of appropriate organizational knowledge : middle-Researchers in ,25 reporRice  applied et al. [et al. [Naeve et al. , review  [et al. , present2.5.et al. [et al. [Becerra-Fernandez et al. , state tet al.  for the et al.  argue thet al. . Balfanz [et al.  argue thIn accordance to , ubiquit3.In  its authet al. [Balmisse et al.  name keyConsidering the arguments and ideas mentioned before, we decided to develop a prototype of a KM system supporting KC in mobile scenarios with people collaboratively working face-to-face, called MCKC, Mobile Collaborative Knowledge Construction. Its design principles are derived from the various results of previous empirical and experimental KC research works and human-computer interface design principles.ad hoc network. It also offers the possibility of synchronizing data on the mobile devices with a central repository when the required networking infrastructure is available, allowing people have access to the existing knowledge anytime and anywhere. The touch-screen mechanism of their displays is used as the main human-computer interaction mean to input information to the system. MCKC implements the free-hand-based command and data input paradigm which means users are able to draw sketches, edit graphic information and enter free-hand written text, as well as using visual metaphors for information management, like conceptual maps consisting of information nodes and relations among them. They can also associate each of the information nodes they create with various documents, like text files, images, etc.MCKC runs on PDAs wirelessly interconnected by an brainwriting/brainsketching, or knowledge externalization support mode, (2) selection of relevant information, or socialization and combination support mode, and (3) visual presentation and knowledge semantics of the created knowledge mode, which is associated to the socialization process. Each mode responds to different requirements. The MCKC conceptual model shown in The system's design is oriented to facilitate KC collaboratively based on the SECI model. According to this, the system has three modes: (1) In order to reduce the productivity problems associated to generation of ideas, during the brainsketching/brainwriting mode each user can externalize her ideas despite there are other colleagues doing the same. MCKC allows each person to use her own device to develop her knowledge, without having to pay attention to other being created by other users at the same time. They can explain their ideas to others in the next step.The three modes of the system are aimed to provide the environment that facilitates tacit to tacit knowledge sharing and construction, without the need to convert tacit knowledge to explicit knowledge before sharing it. There are three major aspects that contribute to make the conversion of tacit knowledge to explicit knowledge difficult: (1) people are unaware of the tacit dimension of their knowledge, (2) is not necessary for an individual to make tacit knowledge explicit in order to use it, and (3) the risk of losing power within the organization by sharing the knowledge. Hence, face-to-face communication should be used to share and personalize tacit knowledge, rather than extract and store it. The exchange of tacit knowledge is viewed as a social process between people that requires face-to-face interaction.MCKC considers social interaction as a key factor for collaborative KC, although it can be also used to support individual KC. As shown in 4.Sketches help to externalize tacit knowledge and hence express ideas and concepts which people have in their minds. They can also help people to order and clarify their own ideas before communicating them to others ,35. The This description is based on a learning scenario experience performed to evaluate the system, where students' task was to develop a marketing strategy proposal for a certain product based on information and specific features about a product. They had to develop ideas about how a new advertising poster for an all-terrain car should look like. The screenshot presented in this section are result of this experience. The results of the evaluation are presented in the next section.ad hoc network between their devices is automatically established. The first view of the interface is a white workspace with icons on the bottom to select one of the three modes the system supports  functionalities supporting brainwriting/brainsketching, selection of relevant information, visual presentation of the knowledge being created, which are principles proposed by the model of conversion of tacit to explicit knowledge; and finally, (c) reducing the productivity loss of groups due to free riding, evaluation apprehension, and production blocking, identified as an aspect the system should help to reduce by anonymously registering the contributions of the participants.In the scenario-based evaluation method , the eva5.1.2.The system was evaluated performing three pilot experiments in real ubiquitous working scenarios involving 18, 12 and 12 test users respectively. The experiments were performed independently of each other with different students. All test user samples were last-year undergraduate students from the School of Business and Economics, of the Universidad de Chile with an average age of 24.6.ad hoc network every time a working meeting was required, a 3.5 inch screen and batteries with the double capacity than the originals in order to achieve a continuous functioning time of at least four hours, which was enough time to perform two meetings a day. Although there are more powerful devices nowadays, the PDAs were powerful enough to run MCKC and it was possible to use a stylus as input device, which facilities the creation of sketches, handwriting and activation of gestures.The first experimental scenario consisted of two groups, totaling 18 students, nine were randomly assigned to the experimental group, and nine to the control group. All of them had already passed the marketing course foreseen in their studies program. Their task was to develop a marketing strategy proposal for a certain product based on information and specific features about a product that has to be released to the marked. For the second and third experimental scenarios two students groups with 12 students each were engaged, six students were randomly assigned to the experimental group, and six to the control group. All of them had already passed the IT and Business course foreseen in their studies program. Their task was to identify a real case for which the introduction of IT would be an improvement. The aim of these activities was to explore how each group of students conducted the necessary KC in order to achieve the proposed goals. In all pilot experimental scenarios, the experimental groups used the MCKC system to support their meetings and the control group was allowed to use pen and pencil and standard “of the shelf” software like word processors, spread sheets, design and drawing software, in their notebooks without touch screen and not using any general application synchronizing software. Students were provided with Compaq Ipaq H3970 PDAs equipped with Windows Pocket PC 2002 operative system, Wi-Fi connectivity, in order to establish an 5.1.3.The research procedure was as follows: First, all experimental and control groups had a session where the task was explained in about 15 minutes. The experimental groups had another session in which they learned how to operate MCKC. This session was 45 minutes long.After the introductory sessions all experimental and control groups of the tree pilot experiments were instructed to have ubiquitous collaborative meetings at anytime and anywhere at the School dependencies in order to propose, discuss and develop ideas for a marketing strategy. Meetings were arranged opportunistically among them or other faculty students and especially with any lecturer they considered relevant to ask for help or to express an opinion in their own offices or right after lectures. The only constrain was that they should have at least six meetings during a period of time of two weeks. So, there should be in average three sessions per week; each session should be from 0.5 to 2 hours long. After this activity the students had to submit a final electronic document describing their ideas for a marketing strategy of the product or a problem with a valuable IT solution. The analysis of the marketing strategy proposal and an added value IT solution tasks were conducted by three marketing, and IT Business experts faculty members respectively and evaluated with marks ranging from 1 (worst) to 7 (best).One day after the last session of each experimental scenario, we asked each student of experimental and control groups to individually complete a semi-structured interview about most positive and negative aspects of the system. The questions of the semi-structured interview were aimed at identifying the impact of the system on the design principles of MCKC described at the beginning of this section. A week after, during which the answers of the semi-structured interview were analyzed, and their frequency registered on a table, six focus groups sessions were performed, one for each performed task, experimental and control group. The focus groups were aimed at validating the results collected during the interviews. After each session, the processes required for knowledge creation and the conversion of tacit into explicit knowledge described in Section 2 were explained to the students and they were asked if they did performed these processes during the performance of the tasks they were assigned. This allowed us to compare to which extend the evaluated system supported the students in performing these processes.5.2.Although all six groups performed the minimum required number of sessions control groups performed less meetings  than the experimental groups . This was mainly attributed to the fact that opportunistic working sessions were easier to initiate using PDAs, contrary to the control groups using standard software, which had to prepare meetings in advance.On the other hand, information generated and used during meetings with MCKC was easily accessible for the next meeting, contrary to the paper sheets which were managed by only some of the control group members which were not easily shared during a meeting.5.2.1.Regarding the tasks we got following results: for the marketing proposal all three faculty members expressed that the quality and completeness of the proposal submitted by the experimental group were better; however the proposal of the control group was fairly good. The experimental group work surpassed the quality of the control group work in identifying more precisely the goal market. Also their strategic plans were more clearly described. The evaluation mark for the experimental group was 6.5 and for the control group 5.3. For the second experiment both the problematic identification and the IT solution proposed were developed with better precision and more solid basis by the experimental group. They received a 6.7 against a 5.5 of the control group. For the third group the marks were not significantly different with a 6.6 for the control group and a 6.1 for the experimental group.5.2.2.functionalities that facilitate information contextualization, face-to-face social interaction, functionalities supporting brainwriting/brainsketching, selection of relevant information; visual presentation of the knowledge being created. For design principles using an easy to use human-computer interface and reducing the productivity loss of groups due to free riding, evaluation apprehension, and production blocking results could not be quantitatively tabulated since they corresponded to qualitative descriptions and were less frequently mentioned than the other principles. Results for these design principles will be explained later. The results for the first mentioned design principles are shown in The answers to the semi-structured interviews were analyzed and tabulated using classification techniques, like dialectic reduction and triangulation, into five categories of the Likert scale: poor, deficient, fair, good, excellent, for the following design principles of MCKC: face-to-face social interaction and selection of relevant information. Interestingly, in this group the quality of the resulting work was not different between the experimental and control groups. Coherently, we find the biggest difference between the average evaluation of the control and experimental group for the first experiment (2.58 against 3.60), where there is also the biggest work quality.In order to have a summary number which reflects how good the students considered the computational support they had en each case for carrying on their task we converted the values of the Likert scale in numbers  and we computed a mean value for each aspect for each group. During the semi-structured interviews the students of the experimental group highlighted the easiness to synchronize data and information input as well as the awareness about who is presenting and/or explaining something to the rest. Second, they said MCKC did not hinder the face-to-face contact, which was also important to achieve their goals. Third, the visualization of the relevant information and the possibility of organizing their ideas under a visual logic was the second most appreciated aspect of the tool. The results of the experiment, as well as the interviews conducted with both groups show that, with high probability, MCKC has a positive impact in KC.Furthermore, the semi-structured interviews revealed that the most difficult aspects to perform for the control groups were the facilitation of information context, and brainstorming/brainsketching processes due to the difficulty to synchronize their work, especially for the group that used pen and paper for making sketches before they prepared the electronic document to submit. Also selection of relevant ideas was reported difficult to perform with standard computer support, especially when the number of participants in the session increased.using an easy to use human-computer interface, we found that the human-computer interface highly contributed to an easier sharing and synchronization of data representing their ideas. This last opinion of members from the experimental group highly contrasts with the opinion of one member of the control group who expressed that sharing the working documents was one of the main difficulties. The use of the three modes of MCKC was considered very useful. Especially appreciated was the opportunity to exteriorize their ideas through sketches they can share immediatelyWith respect to the design principle 5.2.3.The focus groups with all students of the experimental scenarios revealed that the free-riding, production blocking, and evaluation apprehension problems were partially mitigated. The explicit knowledge could be easily specified and communicated with the help of MCKC. It was also noted that that sketches helped to exteriorize and share tacit knowledge. The visualization of the artifacts on the system interface associated to data, information and functionalities triggered by gestures was well accepted and easy to use. However, more experimented users missed the menus, choice boxes and fast access keys.visual presentation and semantic of the created knowledge mode, was perceived as very helpful one because it offers a flexible and rich way to represent knowledge as a final result of a goal. In the second place, the brain-writing/sketching mode was perceived as the most helpful mode. In the whole MCKC was perceived as a relevant tool to support collaborative work because it enables people to contribute, explain, exteriorize and share their ideas. Regarding the usability of the MCKC, in general participants suggested some additional improvements. Participants regarded a major challenge to keep the awareness information and collaboration constantly up-to-date. The learning curve of MCKC was satisfactory completed during the second working session. Some difficulties were perceived on users who declared not having too much experience with mobile and touch screen technologies.The design principle associated to productivity loss of groups due to free riding, evaluation apprehension, and production blocking, than the students from the experimental group, where the participation of all members was higher and conveniently mediated by MCKC. The fact that MCKC users could develop their ideas simultaneously contributed to increase the participation. The anonymity of the contributions allowed for a more objective analysis of the proposed ideas.Students participating in the control group mentioned that they faced more problems related to Finally, during all the focus-groups sessions, after the design principles were explained to the students, the members of the experimental groups considered that MCKC supports knowledge creation processes and the conversion of tacit into explicit knowledge. It is important to mention that although students had some knowledge about the theory of knowledge construction they did not realized that the system they used was actually developed to support this process until the design principles of MCKC were explained to them during the focus group. Even after this explanation many students sustained that most of the knowledge creation work depends more on people's capacity than the computational mediation. Some members of the control group also realized only after the explanation that they were applying some of the knowledge creation principles; however they were not as convinced as their colleagues of the experimental group. They also mentioned that they felt the computer support they used did not really support this process.4.Knowledge construction and tacit to explicit knowledge conversion are important activities in constructivist collaborative learning. People possess a large amount of tacit “hidden” knowledge which has to be converted into “new knowledge”, in order to promote its sharing and innovation. MCKC is a tool that helps externalize knowledge, especially tacit knowledge, among members of a learning group, as the last testing activity we conducted has shown. Our work is based on the empirical and experimental findings of knowledge creation related works, which have been incorporated into the system MCKC presented in this paper. The visualization technology of knowledge and the use of mobile devices as support for knowledge creation is a new field, which has already generated applications for different scenarios such as engineering, education and economy.ad hoc wireless networks, which helps to transform tacit into explicit knowledge, promoting the elicitation, transmission and sharing of information based on sketches. The knowledge management success model developed by [Our application supports the visualization of information in a free and extensible way. It also promotes the collaboration in ubiquitous scenarios by making use of loped by  emphasizAs for the face-to-face channels that users establish and the trust level they might develop during the use of this system, we can say they are more dependent on the individuals themselves than on the support a system like this is able to provide. This means that the effectiveness of any knowledge management system will always depend on the abilities, attitudes and intentions of its users and the level of trust they are able (or willing) to develop. In the near future we will focus on improving many functionalities of the prototype, studying alternative interaction modes, trying to minimize the overhead necessary to maintain data validity. Also, we will conduct more extensive tests of the prototype improved.