All individuals should have the right to engage meaningfully in occupations that meet their aspirations and life goals as well as promote their health and well-being. For individuals with disability, meaningful engagement in occupations is supported by timely, effective, and adaptive health and support services. However, research has revealed multiple barriers preventing utilization of these services by individuals with disability from culturally and linguistically diverse (CALD) backgrounds. This review aims to identify gaps and solutions in health and support services of individuals with disability from CALD backgrounds to meaningfully engage in occupations.A scoping review will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews. A detailed search strategy will be used to search CINAHL, PubMed, Embase, Scopus, PsycInfo, JBI, and Cochrane Library, as well as grey literature in Trove, Mednar, and OpenGrey from January 1974 onwards. Two reviewers will independently screen all citations and full-text articles for eligibility against specific inclusion and exclusion criteria. Potential conflicts will be resolved through discussion. Data will be extracted and presented in a diagrammatic or tabular form accompanied by a narrative summary.The scoping review will present the health and support service needs of individuals with disability from CALD backgrounds and will extend the current reviews as it focuses the engagement in meaningful occupation. Findings from this review have the potential to inform local policy discussions and practice-based disability care.10.17605/OSF.IO/HW2FB).Open Science Framework (The online version contains supplementary material available at 10.1186/s13643-021-01587-8. All individuals should have the right to engage meaningfully in occupations that meet their aspirations and life goals as well as promote their health and well-being . MeaningHowever, there are multiple barriers preventing meaningful engagement in occupations for individuals with disability. This includes policy and practices failing to meet the health and well-being needs of people with disability , 13, sucIn Australia, it was reported that in 2018, 4.4 million Australians are living with a disability, of which approximately 23% are from a culturally and linguistically diverse (CALD) background . The NatConvention on the Rights of Persons with Disabilities, ratified by 181 countries, affirms the rights of individuals with a disability to receive equal opportunity and participation in society and the highest standard of health care without discrimination [Disability Discrimination Act 1992 and Racial Discrimination Act 1975, which make it unlawful to discriminate on the basis of disability and race. Yet in reality, research has revealed that some individuals with disability from CALD backgrounds continue to experience actual and de facto discrimination in accessing and utilizing health and support services [The United Nations mination . Howeverservices .Meaningful engagement in occupations for individuals with disability from CALD backgrounds is largely influenced by both health and support services as they can act as enablers providing care and delivery of resources to improve or maintain function, manage chronic complex conditions, disease, or injury , 28. It The Australian findings are not unique. Similarly in the USA, a study exploring the perspectives of Asian immigrant parents with children who have special health care needs reported parents experiencing cultural and language barriers in their understanding and navigation of the health-care system . Mirza eDue to the heterogeneity of the CALD community and the various types of disability, there does not exist a one size fits all solution. Most of the prominent literature focuses on the multicultural issues encountered by recently arrived refugees and asylum seekers, with other CALD groups being underrepresented . As counThe aim of this scoping review is to identify and describe the health and support service needs of individuals with disability from CALD backgrounds to aid meaningfully engagement in occupations. A scoping review methodology is chosen for its ability to provide a broad overview of the available evidence and include findings from a broader range of CALD individuals with disability , 37.With the completion of the preliminary search on CINAHL in January 2020, no studies were found which discussed the influence of health and support services on meaningful engagement in occupation or what makes occupations meaningful, specific to individuals with disability from CALD backgrounds. Studies referring to other population groups such as individuals with dementia living in residential aged care , and engWhat are the health and support service needs of individuals with disability from CALD backgrounds to meaningfully engage in occupation?What are the gaps in existing health and support services of individuals with disability from CALD backgrounds?The specific review questions that will be guiding this study are as follows:The proposed scoping review will be conducted in accordance with the JBI methodology for scoping reviews , to asseThis scoping review will consider all published and unpublished studies relevant to individuals with disability from CALD backgrounds and their health and support service needs. Individuals from CALD backgrounds are defined mainly by their country of birth, language spoken at home, or characteristics including year of arrival in the adopted country and parents’ country of birth .Disability is defined as the interaction between an individual’s impairment in their body structure or function and their personal and environmental factors that lead to activity limitations and participation restrictions, and prevent meaningful engagement in occupations .The review will consider all studies that describe the health service and health service needs related to individuals with disability from CALD backgrounds. These services are practices that assess, document, maintain, or improve an individual’s health, treat and diagnose illness or disability, or prescribe medication .Studies that describe support service and support needs related to disability will be considered. These services include government services that provide income support to individuals with disability and provision of services and/or funds to organizations to carry out services .Studies that describe meaningful engagement in occupations at a healthcare level will be considered. Meaningful engagement in occupations is the degree to which an individual finds their occupations to be worthwhile, important, and in line with their values and sense of self , 11. OccResearch conducted in primary and secondary health and support care setting will be considered. Primary care is usually the first contact an individual has with the health system and covers the majority of an individual’s health needs, and delivers community-based care by various health professionals , 47, 48.Immigration Restriction Act 1901 was definitively abolished. This Act restricted immigration of people of non-European ethnic origin to Australia; the abolition of this legislation removed the direct discrimination of individuals based on race.This scoping review will consider experimental and quasi-experimental studies, analytical observational studies, descriptive observational studies, qualitative studies, systematic reviews, and text and opinion papers that meet the inclusion criteria. Studies published in the English language will be included. Studies published since January 1974 will be included in order to be comprehensive and attempt to “cover the field”. The index year was chosen as it was the year after the A three-step search strategy will be undertaken . An initThis review will include studies relevant to individuals with disability from CALD backgrounds and their health and support service needs. Following the search, all identified citations will be collated and uploaded into Endnote X9 , and duplicates will be removed. Prior to each stage of screening, reviewers will pilot the eligibility criteria on a random sample of 20 titles/abstracts and 5 full-text studies, with further pilot rounds conducted on an as-needed basis. Titles and abstracts will be screened by at least two independent reviewers  for assessment against the inclusion criteria for the review. An initial calibration will be conducted on 5 randomly selected articles to ensure high inter-rater agreement. The full text of selected literature will be retrieved and assessed in detail against the inclusion criteria .Additional file 3. Inclusion and exclusion criteria.Additional file 4. PRISMA 2009 Flow Diagram.Additional file 5. Data instruction instrument.


People who experienced a mental crisis are involved in providing care for others who face psychiatric hospitalization. The idea of peer workforce has been developed mostly in American and European behavioral health systems. Similar program is implemented to Polish mental health care. The purpose of the study was to find out if candidates for peer support workers with different levels of subjective well-being differed also in terms of general self-efficacy and in the ways of coping with stress.As the problem has not been studied before exploratory study was conducted. The study covered a group of 72 subjects, 46 women and 26 men, aged 21–62 years , former psychiatric patients, preparing for a peer worker role. We used the following questionnaires: Ryff’s Psychological Well-Being (PWB) Scales, in the Polish adaptation by Krok, the General Self-Efficacy Scale (GSES) by Schwarzer and Jerusalem, in adaptation by Schwarzer, Jerusalem and Juczyński and Brief-COPE by Carver, in adaptation by Juczyński and Ogińska-Bulik.The results of cluster analysis pointed to the existence of two groups of individuals with significantly different levels of subjective well-being. Then MANOVA was used. It was determined that individuals with a higher level of well-being were characterized by a higher level of self-efficacy, a higher tendency to use positive reframing strategy and propensity towards active behavior when coping with stress, as well as by a lower propensity towards self-blaming and behavioral disengagement.The study demonstrates that further empirical explorations are justified. The results also encourage a search for some more possible conditions of well-being. It would be advisable to train candidates for mental health peer workers by focusing on the strengthening of their subjective well being and developing active forms of coping with stress. Over the last few decades, firm steps have been taken across the USA and European countries towards the deinstitutionalization of psychiatric health care , 2. TherPursuing a PW role is in line with the assumptions of empowerment, as it makes it possible to strengthen the supporter’s resources and to increase the psychological benefits of the individual receiving the help , 11. TheThe study presented in this paper focuses on subjective well-being (SWB), and on its possible correlates, in former psychiatric patients preparing for a role. PWs use their own experience of overcoming distress and their own abilities to support others who are currently struggling with crisis. The reason for such a study results from the perspective that the EX-IN training for PWs includes self-developmental aspects which should influence their capacity to provide support and to raise their quality of life. Assessing level of SWB and its correlates among participants of PW training may be helpful for designing further work-in-group programs for strengthening particular personal competencies in using psychological resources.is defined as “a person’s cognitive and affective evaluation of his or her life” [. This is a subjective state of general satisfaction with life [Subjective well-being er life” . This isith life , associaith life , making ith life . Ryff [1ith life , 17 propResearch into the determinants of SWB variability over the course of life has not yielded unambiguous results. According to longitudinal studies , importaEqually important may be other psychological resources influencing well-being, described by Taylor and Broffman , which bPerceived self-efficacy, understood as an individual’s conviction concerning their personal ability to meet diverse conditions of the specific task, leading to the achievement of the intended results , reflectAdditionally, adopting stress management strategies may be significant for SWB, especially in the case of strategies focused on task-based approaches to the problem. The situation of mental crisis and psychiatric hospitalization is a very stressful, difficult and complex experience that reduces quality of life , 34. IsoAlthough the well-being of psychiatric hospital patients has been given research attention , it has As the problem has not been studied before exploratory research was conducted. Purposive sampling was used. The study covered participants of the “New Expert” workshops preparing them for a peer worker role, organized by the “Leonardo” Foundation for Social Development in Krakow. These were the first workshops of this kind in Poland organized before the introduction of new legal regulations within the framework of changes in the psychiatric care system. Therefore, the study continuation will be possible after further PW trainings are launched. To avoid the potential effect of completing a workshop on what was measured the participants took part in the study during the first week of the training.The respondents did not receive any remuneration for their participation in the survey and filled out a set of questionnaires using the paper-and-pencil method. All of them were interviewed by one of the researchers face to face in a meeting room after the workshop they participated in. To respond to the research questions quantitative methods were used. Completed questionnaires were carefully checked and the data were input after the interviews.N = 8).The final study sample covered 72 adults who had experienced mental health problems and at least one hospitalization in a 24/7 psychiatric ward. Some participants were excluded from the study because they did not complete all the questionnaires   was useddispositional coping with stress, i.e. to assess the typical ways of reacting and feeling in strongly stressful situations. The tool consists of 28 statements on which the respondents take a position by marking on a Likert scale how frequently they behave in the manner described by the given statement . Each scale comprises 2 statements. This results in a total of 14 scales measuring the frequency of adopting the following coping strategies: Active coping, Planning, Using emotional support, Using instrumental support, Venting, Behavioral disengagement, Self-distraction, Self-blame, Positive reframing, Humor, Denial, Acceptance, Religion, Substance use. The psychometric parameters obtained are satisfactory, split-half reliability is 0.86, the Guttman index 0.87.The Brief-COPE questionnaire  in the Psociodemographic data such as age, gender, education, employment, marital status, living status and medical data such as number of hospitalizations, diagnosed disorder and subjective evaluation of mental health.Additionally, the respondents were asked to provide The measures used in the study are well theoretically grounded tools with good psychometric properties. The application of internationally known measures makes it possible to replicate the findings in different countries and to make transcultural comparisons.The study was conducted with due regard for ethical aspects, according to the principles of the Declaration of Helsinki and its amendments and to procedure approved by the Research Ethics Committee at the SWPS University of Social Sciences and Humanities in Katowice. It ensured anonymity of the respondents. All the individual respondents agreed to participate voluntarily, they were informed about the aim of the study and they all filled out an informed consent form.In order to find an answer to the question concerning the differences between the respondents in terms of SWB, k-mean cluster analysis was used. Since SWB is a multidimensional variable we used the cluster analysis as the best statistical tool that aggregates all the dimensions.Subsequently, in order to find an answer to the questions about the differences in terms of the other variables, the MANOVA method, the Chi-square and the Student’s t tests for independent groups were used to analyze the significance of the differences between the mean results of the said variables obtained by the respondents belonging to the clusters identified.The demographic and medical profile of participants was taken and can be seen in Table The descriptive statistics of the studied variables  and the intercorrelations between the studied variables are presented in Table The k-mean clustering method maximizes the distance between the isolated clusters, and their number is not known a priori. The STATISTICA package includes v-fold cross-validation, which is an algorithm for the automatic determination of the optimal number of clusters. The number of clusters isolated is 2 and corresponds to two groups of respondents, differing to the maximum extent in terms of the individual dimensions of SWB.Table The results demonstrate that the respondents from both clusters that were selected differ significantly in terms of all SWB dimensions, i.e. in terms of autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Individuals belonging to cluster 1 score significantly higher on all SWB scales than those from cluster 2.The results of the comparison between individuals from both clusters in terms of perceived self-efficacy and the strategies for coping with stress the respondents adopted were based on an analysis of the differences between mean values, carried out using the MANOVA method. The results are shown in Table p = 0.01) indicates that the model is statistically significant. Therefore, it should be assumed that there are statistically significant differences between the clusters of respondents that were identified in terms of all the dependent variables taken together.The fact of belonging to the clusters that were identified explains 38% of the variance in terms of the respondents’ SWB, while the multidimensional test for all the effects , education  and work . Cluster 1 has a much higher proportion of women, people with higher education, and people with permanent or temporary jobs than those selected in cluster 2.The analysis of the differences between the clusters in relation to demographic and medical characteristics, conducted using the Chi-square test and the Student’s t test for independent groups, indicated that among all the variables included in Table The results made it possible to distinguish, among the PW workshop participants who were studied, two clusters of individuals differing significantly in terms of the SWB level. The existence of significant differences was also confirmed between individuals from the groups thus distinguished in terms of psychological resources, i.e. traits selected because of their potential significance for SWB, such as perceived self-efficacy and a tendency to apply strategies for coping with stress relying on active coping, positive reframing, behavioral disengagement and self-blame.Referring to the results of the study on SWB conducted by Ryff  and to hThe results indicate that the individuals from the cluster scoring significantly higher on the Subjective Well-Being Scale also have significantly higher self-efficacy scores than the individuals from the other cluster. This continues to be in line with previous studies pointing to positive correlations between SWB and perceived self-efficacy . EffectiIt seems that the presence of dispositions and traits such as activity, tendency to positive reframing, self-confidence, self-efficacy and satisfaction with one’s actions is also desirable in the PW role, given that providing professional help requires confidence in one’s own resources and frequent initiation of actions. According to the results, individuals from the cluster scoring higher on the SWB scale also adopt the strategy for coping with stress consisting in behavioral disengagement and self-blame much less frequently.Higher resourcefulness of subjects from cluster 1 seem to be proved also by other differences between them and subjects from cluster 2: the significantly higher number of persons with higher education and with a job in cluster 1 may also suggest that they have other resources which respondents belonging to cluster 2 may be deprived of. There is also a significantly higher proportion of women in the cluster 1 than in the cluster 2, which may be important. With such a small number of respondents, however, cautious conclusions should be drawn regarding this result.The research has its limitations. The small number of respondents is certainly one of them. However, this was determined by the specificity and unique nature of the sample. The respondents were participants of the one of the first workshop in Poland organized for PWs, so their number was determined by the number of the course participants. Considering the fact that the research was of an exploratory nature, in order to verify the initial observations made here, it is planned to continue the investigations with a much larger sample. This will only be possible in the future once participants of further training courses have been recruited, after the new legislation is enacted. The study does not make it possible either to define the determinants of the differences observed in the level of SWB between the respondents, but the very acknowledgement of the existence of such differences may contribute to building in-depth models of dependence analyses.SWB, in eudemonistic terms, is a significant determinant of satisfactory relationships with other people, a predictor of commitment to work, a trait correlated positively with openness towards experience, the tendency to compromise and conscientiousness, and negatively with neuroticism, a trait considered both as a consequence of the earlier health condition and as a predictor of mental and physical health . Taking The research methodology could be improved by triangulating it with qualitative methods, for example ones based on interpretative phenomenological analysis, allowing the participants to express themselves more freely when describing their feelings concerning well-being and its determinants. Other psychological resources, such as resilience, self-esteem and optimism, could also be taken into account in further studies of PW candidates.Social support, which is an important resource as a predictor of well-being and coping with stress , 47, notResearch implications suggest that the findings may be important for the practice. It would be advisable to train individuals preparing for a PW role by focusing on the strengthening of SWB and its personality-related correlates and developing active forms of coping with stress. Thus interventions and trainings might help promote health, improve the quality of life of former psychiatric patients and, finally, help them to support others.This preliminary analysis shows that there are statistically significant differences between candidates for PW role. The respondents differ significantly in terms of SWB. Those with higher SWB also have higher perceived self-efficacy, less often cope with stress by refraining from an attempt to resolve the difficult situation and blaming themselves, and are more determined to use positive reframing strategy, notice the optimistic aspects of the situation and actively fight. Continuation of the study will be possible after further PW trainings are launched.


Following publication of this article , concernPLOS Neglected Tropical Diseases Editors-in-Chief and members of the PLOS Neglected Tropical Diseases Editorial Board evaluated the article and the issues raised, and determined that this review includes unreliable information; that statements regarding clinical diagnosis and treatment are not adequately supported by published findings; and that in light of these issues, the review could introduce potential risk to patient care.The authors confirmed there were numerous errors in the article. The Specific issues confirmed in the editorial assessment include the following, which are discussed in more detail in :Burkholderia pseudomallei to antibiotics is inaccurate.In the section, ‘Antibiotic resistance and susceptibility/treatment of melioidosis,’ the characterization of the resistance and susceptibility of The section, ‘Laboratory diagnosis’ includes inaccurate and incomplete information that does not reflect current guidelines and knowledge in this area. Critical information regarding the interpretation of diagnostic results is missing.The discussion of treatments includes several statements that are not supported by randomized controlled trials, or in some cases, that do not align with clinical practice standards in place at the time of the publication of the review. Statements of concern include those discussing the standard oral treatment, the utility of third-generation antibiotics, and the efficacy of combination treatment , fluoroquinolones, and immunotherapy.The discussion of geographical distribution, disease incidence, and ecology, does not discuss some key articles that were published prior to the review.Table 1 ”) does not include all countries where melioidosis is present and does not accurately report the number of published cases per country in some cases.The section, ‘Development of antibodies and vaccines for prevention of melioidosis,’ lacks information about relevant advances.PLOS Neglected Tropical Diseases Editors-in-Chief have determined that this review article is unreliable in light of the above issues, and we are therefore retracting this article. We regret that these issues were not addressed during the article’s pre-publication peer review.The RPS, GS, and LHKL disagreed with retraction. BGS either did not reply directly or could not be reached.LHKL apologized for the errors in the article. RPS commented that the issues in this case could have been addressed through revisions had they been raised prior to the article’s publication.


The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa initiative, reflects on what has been realized in six years of operation and what still needs to be achieved. Statistics for the work done by the initiative are available in the literature, but there has not been a critical review of the process, including an analysis of factors contributing to the success of the initiative and conversely those negatively affecting performance. To do this, publicly available literature and statistics, meeting records, terms of reference and unpublished documents belonging to the initiative were reviewed. The successes of the ZaZiBoNa initiative can be attributed to leadership commitment, a clear vision and governance structure providing direction, and a clear, documented operating model, processes and objectives defined from the onset of the initiative. Closure of the gaps that were identified and implementation of the recommendations that were made in this paper will further strengthen the initiative. Furthermore, other regional harmonization or work-sharing initiatives on the African continent and beyond can draw lessons from this review of the ZaZiBoNa initiative for improved efficiency and effectiveness. The regulation of medicines contributes to public health by ensuring that medicines are safe, effective, and of good quality. The capacity to regulate medicines varies across the African continent, with all countries except Sahrawi Arab Democratic Republic having either a regulatory agency or a unit within the ministry responsible for health and dealing with issues relating to the regulation of medicines . The WorTo address these challenges, a great deal of work has been done over the years to strengthen regulatory systems in Africa, including the formation of the African Medicines Registration Harmonisation Initiative (AMRH), which encouraged harmonization of the fragmented regulatory systems in the continent. The AMRH is a program of the African Union established in 2009 and implemented as part of the Pharmaceutical Manufacturing Plan for Africa to address challenges faced by national medicines regulatory authorities (NMRAs) in Africa such as ineffective legislative frameworks, long registration times, and inadequate technical capacity . PharmacThere are eight regional economic communities (RECs) recognized by the African Union, such as the East African Community (EAC), the Economic Community of West African States (ECOWAS), and the Southern African Development Community (SADC) , 8 and i, Sigonda and colleagues recommended that a critical review of these joint review processes such as the SADC key initiative of Collaborative Medicines Registration (ZaZiBoNa) be undertaken to evaluate the efficiency and effectiveness of the decision-making processes at a country level [Whilst a great deal of success has been realized by the regional harmonization initiativesry level . This paSADC is a REC of the African continent consisting of 16 countries, Angola, Botswana, Comoros Islands, Democratic Republic of Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, United Republic of Tanzania, Zambia, and Zimbabwe . CountriThe ZaZiBoNa collaborative medicines registration initiative was established in 2013 by four countries, Zambia, Zimbabwe, Botswana, and Namibia, with technical support from the WHO Prequalification Team (PQT) –18. The ensure that at least 80% of member states have NMRAs that meet minimum standards,ensure regional harmonization of medicines regulatory systems and guidelines,facilitate capacity building of medicines regulatory authorities in member states through implementation of quality management systems (QMS) anddevelop and implement national and regional integrated information management systems (IMS) to facilitate decision-making and sharing of knowledge among member states and stakeholders.” .The collaborative initiative began with the first assessment session, held in Windhoek, Namibia in October 2013. These assessments initially looked at applications common to the four countries that were pending in the backlog, but expanded over time to review products submitted prospectively. In 2014, the ZaZiBoNa initiative was formally endorsed and adopted by the SADC Ministers of Health . The ZaZVarious activities are ongoing currently to fulfill these objectives, for example, most SADC countries have conducted self-benchmarking of their regulatory systems using the WHO global benchmarking tool (GBT) . In addiThe ZaZiBoNa initiative is not a legally constituted regulatory initiative and does not make decisions on the registration or rejection of products  but rathThe Heads of Agencies serve as the governance structure for the initiative , 24 and Participation in this initiative is voluntary and any SADC country wishing to participate submits an application or request to join to the Heads of Agencies through the SADC MRH Coordinator . CountriAngola, Seychelles, Swaziland, and Madagascar participate in ZaZiBoNa as non-active members and Comoros Islands, Lesotho, and Mauritius are the few remaining SADC countries not yet participating in the initiative.Products eligible for assessment under the ZaZiBoNa initiative consist of all essential medicines and medicines used in the treatment of the SADC priority diseases or conditions ; and reproductive health products and products included in the list of United Nations Commission for Life-Saving Commodities for Women and Children , 19. In The WHO-prequalified products are not eligible for consideration under ZaZiBoNa, as most SADC countries participate in the WHO prequalification collaborative registration procedure , in whicAssessment sessions are held quarterly, with all participating countries hosting the meetings on a rotational basis. Hosting countries are responsible for covering meeting expenses, which is how countries contribute to the initiative. SADC, WHO PQ, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and EMA guidelines are used for the assessments.The applicant submits the same application for registration (dossier) including payment of the appropriate fees to each participating country in which they wish to market their product. At this stage, the applicant also expresses interest for their product to be assessed by ZaZiBoNa. At present, the dossier must be submitted to at least two active countries to be eligible for consideration under ZaZiBoNa.The assessments coordinator assigns one country to conduct the first review (rapporteur) and a second country to conduct a second review (co-rapporteur) of the product. The WHO is responsible for performing a quality assurance check of the final reports generated by the rapporteur and co-rapporteur.Upon request, the applicant submits a signed letter of consent to the rapporteur to allow consideration of their product under the initiative. The applicant is informed of the countries participating in the initiative before giving consent.Assessments are carried out in the countries before discussion at the quarterly assessment sessions.Once the assessment is complete , a recommendation on the quality of the product is made to the countries, who then make the final decision on registration or rejection of the product after consideration of any country-specific requirements.Because there is no centralized submission of dossiers to ZaZiBoNa, the following steps are followed for an application for registration to be assessed by the initiative .The applThe review process is further illustrated in Fig. The assessments coordinator liaises with the GMP inspections coordinator for products that have been assessed and the sites requiring inspection.The GMP inspections coordinator liaises with the manufacturer to schedule an inspection and quote the applicable inspection fees.The GMP inspections coordinator assigns a lead inspector and co-inspector from the countries to which the product has been submitted and in accordance with the pre-agreed inspectors’ rotational calendar.An inspection is conducted and a final report is prepared in consultation with the rest of the inspectors in ZaZiBoNa. A final compliance status is reached collaboratively after submission and consideration of corrective and preventive actions (CAPAs)The final decision is then communicated to the assessment coordinator for consideration when the final recommendation is made for the product.At present, ZaZiBoNa good manufacturing practices (GMP) inspections are conducted on a cost-recovery basis to support product registration, while capacity building for participating member states is supported by development partners. The WHO PQT guidelines are used for inspections and GMP site visits are conducted four times a year, with two manufacturing facilities inspected during each visit. Sites in well-resourced markets like the United States, European Union, Australia, Japan, and Canada are normally exempt from GMP inspections. Desk reviews may be conducted instead of actual inspections for sites that would have been inspected by stringent authorities and the WHO PQT. The scheduling of inspections and the coordination of inspectors from different countries is carried out by the Medicines Control Authority of Zimbabwe, which is the SADC MRH-implementing agency. Each site-inspecting team normally comprises a lead inspector, a co-inspector, and an observer, each from a different country, with the lead and co-inspector roles rotated among participating countries with competent GMP inspectors . The folThe initiative is funded through contributions from participating countries, GMP inspection fees and support from partners including the SADC, United Kingdom Department of International Development-funded Southern African Regional Programme on Access to Medicines and Diagnostics (SARPAM), WHO, Bill and Melinda Gates Foundation, African Union Development Agency New Partnership for Africa’s Development (AUDA-NEPAD) and the World Bank. From the outset of ZaZiBoNa, the Heads of Agencies stressed country investment in the initiative, and this emphasis and its frugal financial model will ensure sustainability in the even in the absence of this partner support.For the six years from the beginning of the initiative until October 2019, 24 assessment sessions were held, with an average of 12 products considered per session. Sixteen training sessions were also held during this time and the Heads of Agencies have met twice per year.As of October 2019, a total of 289 products had been considered under the initiative, 203 have been finalized and 86 are pending. Of those that have been finalized, 56% received a positive recommendation, 20% received a negative recommendation, and 24% were withdrawn voluntarily by the applicants . Of thesThe target median time to a ZaZiBoNa recommendation or scientific opinion is 9 months, inclusive of the applicants’ time to respond to queries. The actual performance for the years 2014 to 2019 is displayed in Fig. In 2014, the median time to recommendation was 5 months (range 3–12 months), in 2015, it was 9 months (range 4–16 months), in 2016 it was 9 months range 5–24 months), in 2017 it was 9 months  months,  months, As of September 2019, 38 manufacturing sites have been inspected and 19 desk reviews conducted. An inspection of one clinical research organization (CRO) was conducted with technical assistance from WHO. In addition to the inspection of manufacturing facilities, policy meetings for managers are held annually, GMP technical working group meetings are held quarterly, and inspectors’ meetings are held biannually . The timResults achieved by the ZaZiBoNa initiative demonstrate that leadership commitment, determination, consistency, and ownership have enabled successful work sharing. Medicine registration has been faster through ZaZiBoNa than it would normally take in most of the individual countries . The iniAlthough the initiative has had successful outcomes, a number of challenges have also been identified in the years since its inception .As previously described, each country makes a sovereign decision on the registration or rejection of a product once the technical assessment of a product is completed and a recommendation made through ZaZiBoNa . In an iAnother identified gap was that in some instances, applicants were not responding to queries in a timely manner, thereby lengthening the total time to recommendation, and by extension, to registration . This gaThe countries in the ZaZiBoNa initiative face the common challenge of long registration review times due to an increasing volume of applications, huge backlogs , an inadAlthough the ZaZiBoNa initiative currently mainly focuses on generics and has review templates for quality and bioequivalence, Gwaza recommended expansion of the current model to include reviews of new medicines for diseases endemic to Africa . The neeSubmission of applications to ZaZiBoNa is not centralized and applicants have been challenged by the fact that the process is not clearly detailed by some agencies. In addition, country-specific requirements such as those for labeling can be problematic, although a regional guideline on labeling is currently under development. Finally, some manufacturers submit different dossiers to individual countries through the ZaZiBoNa initiative, despite the requirement for identical submissions to all countries in which registration is sought.Historically, regulatory agencies have used some form of documents to record their review. Such documents have often been referred to as a checklist, and often offers limited information. More recently, regulatory authorities involved in the evaluation of new medicines recognize that to have a structured, systematic approach incorporated into an assessment template offers major advantages in support of their decision, including transparency.Transparency, consistency, and uniformity in the assessment of medicines and decision-making are the hallmarks of a mature and progressive regulatory process. There is now an ever-greater need for a universal standardized template, as regulatory agencies move toward collaborative initiatives and reliance on one another’s review processes and outcomes. Currently, regulatory agencies may make different decisions despite having the same data on new medicines submitted to their authority, leading to increased pressure to improve agency transparency and accountability and therefore requiring the establishment of an appropriate, structured, systematic approach to the assessment of such products .The use of a systematic, structured, and transparent approach for the benefit–risk assessment of new medicines is in line with good review practices . The impDifferences in the regulatory review process in countries can hinder the performance of a work-sharing initiative. There is a need to evaluate the regulatory review process in ZaZiBoNa as well as the review processes in the individual participating countries, using established and validated tools to compare the outcomes. This will support the standardization of country processes, enabling improvement and capacity building where required. In addition to identifying the differences in the processes in countries currently participating in the ZaZiBoNa initiative, the review of regulatory processes will enable low- to middle-income countries (LMIC) to benchmark processes, resources, and capacity against similar countries, something which has not been possible to do in the past .The use of manual tracking systems in the countries is a major contributor to protracted timelines for registration, and ideally, tracking should be automated and carried out in real time. The use of available tracking tools through adoption or adaptation will make it possible to track deadlines for response to queries and enable countries to report both the time taken by the applicant (clock start) as well as the time taken by the agency (clock stop). Another advantage is that countries will be able to accurately and regularly report and publish statistics of their performance against target timelines. This transparency will aid achievement of one of the goals of the SADC Medicines Registration Harmonisation program, which is for member states to attain either maturity level 2 or 3, using the WHO Global Benchmarking Tool, depending on the current capacity of the agency.Due to the high cost of biologicals and an increasing burden of non-communicable diseases such as cancers in low- to middle-income countries, especially in sub-Saharan Africa, there is a growing demand for biosimilars . ConsequIt has been proposed that the RECs such as ZaZiBoNa serve as technical working groups under the soon-to-be-launched African Medicines Agency, which will be responsible for assessing new chemical entities as well as complex products such as biologicals and biosimilars. Implementation of the proposals made above will help to identify any gaps or areas needing improvement to enable the initiative to efficiently execute this mandate.The regulatory review process in ZaZiBoNa as well as the review processes in the individual participating countries should be evaluated using established and validated tools and the outcomes compared.ZaZiBoNa should explore developing a structured, transparent, and semi-quantitative approach to benefit–risk assessment, including the assignment of relative importance to benefit and risk considerations and develop standardized templates for new chemical entities, biologicals, and biosimilars.Good Review practices such as quality decision-making should also be explored to improve decision-making practices of the assessors and the national agencies as well as the ZaZiBoNa initiative.ZaZiBoNa countries should implement electronic information management systems to enable automated tracking of timelines.www.zazibona.com (accessed December 2019) and contains information on the background and formation of the initiative, how it works, and the guidelines that are used. The website should be improved to provide clearer information to applicants on the submission process, including contact details of the focal persons in each country to enable smooth follow-up of pending applications. Products registered through the initiative as well as the countries in which the products have been registered should be accessible via this website. In addition, all NMRA websites in the region should carry information on the ZaZiBoNa initiative as an alternative registration pathway. This will serve as advocacy for the initiative and address the challenges faced with the submission process.A website for ZAZIBONA was recently published on The aim of this paper was to review the history of the ZaZiBoNa initiative, reflecting on what has been realized in its years of operation, and what still needs to be achieved. Proposals are presented to address the challenges identified with some additional recommendations to further strengthen the initiative. The ZaZiBoNa initiative is continuously endeavoring to improve its performance and ensure the quality of its regulatory reviews. It plays an important role in improving the regulatory review processes in the individual participating countries but its success is also dependent on the very same country processes. In view of this mutual relationship, there is a need to assess the regulatory review process of the initiative as well as the participating countries in order to ultimately improve efficiency and effectiveness.


Coronavirus disease 2019 has had a dramatic effect on society and healthcare. Preparations were based on predictive models of need, and with uncertainty regarding risk to patients and healthcare workers. Actions taken had both immediate and ongoing ethical impacts. The most obvious of these was the shift in duty of care from individual patients to public health centred ethics and decision making.In ENT, many procedures are aerosol-generating and so our capacity to provide care will remain significantly reduced. This reduction in capacity may result in difficult choices for patients when optimal care may be replaced by acceptable care. ENT surgeons may also be faced with unaccustomed paternalism when capacity prevents them from acting within the patients’ wishes.Despite these challenges, the novel uses of technology highlight the desire to preserve and enhance the autonomy of our patients. In the UK alone, 290 147 people have been confirmed to have Covid-19, and 41 128 have succumbed to the condition.2 Actions taken had both immediate and ongoing effects, changing every aspect of medical care overnight.3 Surgeons across all specialties saw elective work cancelled, and they were required to change both their model of work and the ethical principles of their day-to-day practice dramatically. We have all been faced, with and continue to face, issues relating to duty and standard of care, as well as our obligations to society, public health and ourselves.Society as a whole and healthcare services in particular have had to prepare based on predictive models of need, and with uncertainty regarding risk to patients and healthcare workers themselves.The shift in duty of care from individual patients to public health centred ethics and decision making has been seen most dramatically in the cessation of elective surgery. The reduction in elective surgery freed up operating theatre space, ventilators and hospital beds for patients during a surge in Covid-19 cases, and preserved personal protective equipment (PPE) for those involved in their care. Delays in treatment on such a scale as this would not normally be tolerated, given the risk of harm both physical and psychological to individual patients. These concerns were overwhelmed by the moral need to save lives, prevent the spread of Covid-19 and ‘flatten the curve’.4 As a result, the timely and evidenced-based care of even urgent conditions such as airway stenosis or malignancy is affected. The choices are not solely related to distributive justice or resource availability; we must also respect the autonomy of those patients requiring care. Whilst it would seem self-evident to treat a patient with cancer, we also know that such treatment will result in reduced World Health Organization performance status and increased vulnerability to the virus. Treatment requires exposure to the clinical setting, and the likelihood of iatrogenic infection in these high-risk patients, who are vulnerable to poorer outcomes, only enhances the difficulty of the choices we must support patients in making.5As society undergoes a stepwise reduction in restrictions on liberty, so too healthcare must follow a stepwise path to recommence elective assessments and procedures. Those patients who stand to suffer most greatly from a delay or cancellation in their surgical procedure must be identified. Whilst it is perhaps not unusual to grade a waiting list by necessity, or to decide to cancel the patient last on the list as a result of an earlier delay, the scale of current restrictions is unfamiliar and shocking to most surgeons in the developed world. In the UK prior to Covid-19, we may have wished for more operating time, but now the use of the operating theatre and PPE is greatly restricted. In ENT, where many procedures are categorised as aerosol-generating procedures, operating theatre time may be at an even higher premium.The immediate changes in care during the Covid-19 peak also resulted in a dramatic shift in the day-to-day work of ENT surgeons. Remote access to in-patient data and imaging, as well as telemedicine clinics, allowed for the remote provision of guidance and surveillance of patients. These methods enabled the triage of those patients requiring management by face-to-face services. Having the minimum staff required in the hospital, whilst contrary to the routine and lifestyle of many surgeons, served the important purpose of preserving the medical workforce so as to prevent shortage at a later date.6 In light of the potential numbers of patients with Covid-19, many ENT surgeons found themselves called upon to function outside their normal zone of practice. Whilst undoubtedly challenging, both morally and clinically, for the individuals working in Nightingale units or elsewhere, ENT surgeons have a breadth of skills and ability to help patients beyond the narrow confines of their subspecialties. The application of these skills upholds our duty and responsibility as doctors to care, and is in keeping with the history of both our specialty and our profession.These changes in practice draw into focus the standard of care provided, as Covid-19 shifted the boundaries of what is optimal treatment and what is acceptable treatment. This challenging ethical issue is not new to ENT given the breadth of clinical practice provided in our specialty. An otologist must be trained in and be capable of draining a deep space neck infection, just as a head and neck surgeon must be capable of a cortical mastoidectomy. This necessity is reflected throughout ENT training.vs Lanarkshire Health Board case (2015), which concerned risk disclosure for informed consent), and the General Medical Council guidance entitled ‘Consent: Patients and Doctors Making Decisions Together’, is focused on information provision, discussion, respect for patient values and shared decision making.8 The restrictions placed on out-patient and operative space discussed above may increasingly result in an inability to respect our patients’ autonomy and right to self-determination. Initially, it is important to clarify with patients if they are willing to accept the risk of undergoing surgery during the Covid-19 pandemic. In light of the Montgomery ruling, this will require discussion of the screening process in place for both operating theatre staff and the patient themselves. It does, however, seem likely that as numbers of new referrals continue to outstrip patients completing surgical care, the frequency with which we are able to respect patient choice in a timely fashion may fall below both what has happened historically and what would be deemed either optimal or acceptable.The ongoing requirement to find balance between what is optimal and what is acceptable makes a shift to greater paternalism more likely than we have been used to in recent practice. Surgical care in the post-Montgomery era (Montgomery The scarcity of PPE, and the potential for shortages both during the initial peak in cases and going forward, draws the responsibility and duty of care for all clinicians into further consideration. The duty of care to work in environments outside of our norms is clear; however, that responsibility does not extend to working in those environments without adequate PPE. During the initial Covid-19 peak in the UK and abroad, illness within healthcare was a significant concern; as such, medical and allied health staff became a limited resource. To practice in the absence of adequate PPE is not so much an act of heroism as an irresponsible act that may reduce the efficacy of care.Despite the shift in duty of care from individual patients to public health centred ethics, the impact on care provision and decision making, and the potential increase in paternalism, the Covid-19 pandemic reminds us all of the need to continue to meet the moral premise of all medical practice, to help our patients. The efforts around the country, and indeed the world, to reduce patient waiting times and risk, through novel uses of telemedicine, remote communication with colleagues, enhanced triage of referrals and many other means, highlight the desire to preserve and enhance the autonomy of our patients.


Malaria is an infectious disease that annually presents around 200,000 cases in Brazil. The availability of data on malaria is crucial for enabling and supporting studies that can promote actions to prevent it. Therefore, the goal of this paper is to contribute to such studies by offering an integrated dataset containing data on reported and suspected cases of malaria in the Brazilian Legal Amazon comprising the period from the years 2009 to 2019.This paper presents a dataset with all medical records of patients who were tested for malaria in the Brazilian Legal Amazon from 2009 to 2019. The dataset has 40 attributes and 22,923,977 records of suspected cases of malaria. Around 12% of the data correspond to confirmed cases of malaria. The attributes include data regarding the notifications, examinations, as well as personal patient information, which are organized into health regions. Since 2003, the Health Surveillance Secretariat of the Ministry of Health implemented, in Brazil, the Malaria Epidemiological Surveillance Information System , which is a malaria monitoring system in nine Brazilian states of the Brazilian Legal Amazon . The Legal Amazon is the region most susceptible to malaria in the country, comprehending more than 90% of the malaria cases in Brazil .All suspected or confirmed cases of malaria are be notified and registered in SivepMalaria . The infIn Brazil, the Unified Health System (SUS) is responsible for providing public health services to the entire population. As a way of organizing these services, the Brazilian territory is divided into health regions. Each health region is organized as a set of counties that must be able to promote health and prevent diseases for the counties it encompasses, including endemic diseases, such as malaria. Analyzing the performance of health regions in care and prevention of malaria is an important matter in the Legal Amazon.Therefore, the main contribution of this work is to provide an integrated dataset of malaria notifications  . The IntIn the area of healthcare, the process of Knowledge Discovery from Databases (KDD) may enable diagnostics, treatments, as well as preventive measures –9. The dData fusion was applied over data from SivepMalaria yearly collected since 2009, configuring the fusion of all SivepMalaria records . Since SivepMalaria was implemented, its schema has suffered changes throughout the years, including new variables or modifying categories in the same variable. Nevertheless, the integrated dataset developed in this paper provides a unified schema by means of a correspondence table. It contains 40 attributes from the SivepMalaria database containing 22,923,977 records. Among these records, about 12% corresponds to positive cases of malaria.The selected dataset attributes comprise data of notifications, examinations, and personal patient information. Most of these attributes are categorical and present encoded values. The relationship between the codes and their meanings are translated using a data dictionary.1The health regions are part of the systemic organization of the public health of Brazil, aiming at political-administrative decentralization and completeness of assistance. Since the SivepMalariaFus does not include this information, it had to be obtained from another data source. For that, two additional datasets were used for enriching the data contained in the SivepMalariaFus. Respectively, they regard: (i) health regions information (tb_regsaud) and (ii) the relationship between counties and health regions (rl_municip_regsaud). These tables are provided by DATASUS.2The enrichment led to the creation of three new attributes: notification.hr, infection.hr and home.hr. They correspond respectively to the health regions in which the notification and infection occurred as well as to the residence of the infected patient.After the processes of data fusion and enrichment, data preprocessing was performed. Preprocessing comprehend the application of several techniques for data preparation, that can encompass from the correction or removal of incorrect data to the adjustment of data formatting corresponding to the data mining algorithms used. Among the several preprocessing techniques widely approached in literature, the ones selected for application in our study were (i) attribute selection, (ii) data cleaning, and (iii) data transformation.The list of the attributes of IntegratedDataset together with the entire data preprocessing description and its R script is availablePersonal patient information is only provided for those who tested positive for malaria.Some attributes contain more than 80% of missing values. The data dictionary presents the completeness of each attribute in the IntegratedDataset. No data imputation technique has been applied.Some values do not add significant information to the research. For example, in the occupation attribute, more than 50% of the fields that are filled correspond to the values “ignored” or “others”.To reinforce privacy, we have chosen not to use the attributes of localities (infection and residence) available in the original dataset of SivepMalaria. Localities are smaller than counties and provide very specific information. Inevitably, disregarding this information is a limitation.


This article presents the design process of innovative prototypes for cervical cancer prevention in primary care centers located in low-income settings in Cali, Colombia, using the Human-Centered Design (HCD). The project was developed in collaboration with a public healthcare network comprised of 38 urban and rural centers with women between the ages of 25 and 65 years, healthcare providers of the cancer program, healthcare administrators and the general manager of said network. Our HCD process involved five stages: research, need synthesis, ideation and co-design process, prototyping and in-context usability testing. In practice, some of the stages are overlapped and iterated throughout the design process. We conducted observations, open-ended interviews and conversations, multi-stakeholder workshops, focus groups, systematic text condensation analyses and tests in real contexts. As a result, we designed four prototypes: (1) ‘Encanto’: An educational manicure service, (2) ‘No le des la espalda a la citología’: A media-based strategy, (3) An educational wireless queuing device in the waiting room, and (4) Citobot: A cervical cancer early detection device, system, and method. The tests carried out with each prototype showed their value, limitations and possibilities in terms of subsequent development and validation through public health research or clinical research. We recognize that a longer-term evaluation is required in order to determine whether the prototypes will be used regularly, integrated into cervical cancer screening services and effectively improve access to cytology as a screening test. We conclude that HCD is a useful for design-based prevention in the field of cervical cancer. The integration of this approach with public health research would allow the generation of evidence during to the formulation of policies and programs as well as optimize existing interventions and, ultimately, facilitate the scalability and financing of what actually works. Cervical cancer currently ranks fourth among cancer types and is the fourth most common cause of cancer-associated death worldwide . In 2018Traditional public health approaches to cervical cancer prevention reported in Latin America have been focused on screening and health education; and in recent years, in vaccination against Human Papillomavirus (HPV) ,5. CountDespite advances in early detection, scientific literature shows that Latin American women continue to experience barriers . StructuThis shows that it is necessary to develop renewed forms of prevention that allow improving women accessibility to prevention programs, especially those with low incomes. An opportunity to generate these innovations is in the field of Human-Centered Design (HCD) that initially originated in the areas of ergonomics, computing and artificial intelligence while trying to make systems more interactive and usable by people . CurrentThe importance of applying HCD in the health sector is being progressively embraced. Health design is a relatively incipient area of research and development of an interdisciplinary nature where the fields of design, health, engineering, physiotherapy, occupational therapy and social research converge . Design In public health and more specifically in cervical cancer prevention, HCD can improve the commitment of the community; streamline both the identification of challenges and the design and implementation of programs that tackle complex issues .Stakeholder and key community engagement is critical to effectively transfer to the real context. Communities and members who would implement innovations must become active partners in its refinement during design. Thus, the results of the communitarian co-design are useful for complex problems solutions analysis and development, with longer-term impacts . A scopiIn Colombia, cervical cancer is the fourth cause of death by cancer in women, with an incidence rate of 12,7 per 100,000 women and a mortality rate of 5,7 per 100,000 women ,42–44. I’, we formed an interdisciplinary team with the purpose of contributing to the improvement of access to cervical cancer prevention using the HCD. We sought to truly involve women, communities, managers and providers of healthcare services in the co-creation of the proposals. In this article, we present the results of the first phase, centered on the design of functional prototypes, proposed by HCD as a method to identify and refine promising ideas aimed at innovative solutions [Catering to these needs and in the context of the macro-project titled ‘Strengthening accessibility to preventive services in primary care centers in Cali, Colombiaolutions . In thishttps://sugar-network.org/network) composed of universities around the world such as Aalto University (Finland), Trinity College Dublin (Ireland), Swinburne University of Technology , École des Ponts ParisTech (France), University of St. Gallen (Switzerland), Kyoto Institute of Technology (Japan), University of Sao Paulo (Brazil), among others. Since 2007 the Pontificia Universidad Javeriana Cali, Colombia through a global interdisciplinary course on HCD (ME310) has participated in the creation of more than 30 new products and services that have been developed for international companies such as Autodesk, Kodak, Panasonic, Tupperware, Telefónica, Yanmar, Valeo, Philips, and Berg, and for Colombian companies such as Belcorp, Banco de Occidente, Carvajal, Forsa, Totto and Grupo SURA [This study is linked to the network SUGAR ’ in 38 urban and rural public health centers. In 2018, this healthcare network had a registry of 174,774 women between the ages of 25 and 65 years. The participants were women that were scheduled to take the cervical cytology, women that had never taken it, healthcare providers of the cancer program, the healthcare centers administrators and the general manager of the network.Research team consisted of two public health experts with experience in health services research in Colombia, a leading HCD practitioner in ME310, two clinicians with experience in detection and care services for women with cervical cancer, two experts in computer science and electronics and a graphic designer. Data collection process was also supported by two Master’s in Public Health. The study was reviewed and approved by the Ethics Committee of the Faculty of Health Sciences of the Pontificia Universidad Javeriana Cali, Colombia. All participants in each group  signed the respective informed consent according to the stage or prototype test of which they took part. The individual in this manuscript has given written informed consent (as outlined in PLOS consent form) to publish these case details.HCD is a process used to gather information regarding the needs of the beneficiaries of an innovation, create innovative approaches to meet said needs, and offer solutions that work in specific socio-economic contexts ,52. Its Literature has reported tension between the way HCD research is carried out versus traditional health research, mainly affecting the reporting and publication of reports . HoweverIn our case, the purpose was to move away from the traditional forms of cervical cancer prevention, focusing on the needs of all parties involved in accessibility to cytology, as the main screening test in primary healthcare centers. This is how our methodological route integrated HCD with public health research, particularly with health services research. For a proper dissemination of our work in peer-reviewed literature we follow both the COREQ guidelines  for repoi. Research, ii. Need synthesis, iii. Ideation and co-design process, iv. Prototyping and v. In context usability testing. To data collection, we used observations, open-ended interviews and conversations, multi-stakeholder workshops, surveys, focus groups, systematic text condensation analysis and tests in real context and simulated hospital. In practice, the stages overlapped and iterated throughout the design process developed between January and December 2018. In the first six months, we carry out the initial 3 stages and in the next six months we prototyped and performed usability testing.This project is comprised of five stages: We carried out participant observations in all the public health centers of the ‘Red de Salud Ladera’ (n = 38). Initially we observe geographical barriers, physical accessibility and infrastructure for healthcare service delivery. Next, we registered observations from waiting rooms, administrative offices, consulting offices and available equipment and inputs for cervical cytology. The total hours of observation were 114 and were carried out by the design team and personnel previously trained in the participant observation technique. We recorded the observations using field notes detailing the general context and cervical cytology provision in each healthcare center.On a subsequent moment, we carried out open-ended interviews with women for which we used a purposive sampling with volunteers classified into two groups: women with and women without cytology in the last six months. We interviewed women with cervical cytology in the waiting rooms of the healthcare centers (n = 35). We used an interview guide with prior content validation by expert judgments seeking socio-demographic information, knowledge on cervical cancer and cytology, and the perception of the experience before, during and after taking this test. In turn, we identified women without cytology in the databases of the health centers, contacted them by telephone, interviewed them in the health centers with previously agreed appointments and explored the reasons why the Pap test had not been performed (n = 18). All the women interviewed were in an age range between 18 and 71 years, mostly housewives and informal workers.On the other hand, we conducted open-ended conversations guided by discussion guides with healthcare providers  and administrators of healthcare centers selected by convenience sampling. In these conversations we explored their general perception of the cervical cancer prevention program, the motives expressed by women to avoid taking a cervical cytology, how to build a relationship with patients during the test, and the follow-up process on the delivery of results, diagnosis and treatment. All the interviews and conversations were audio recorded for later transcription and analysis.To complete this research stage, we carried out a benchmarking on the internet with the purpose of finding ways to respond to challenges similar to the one proposed in this project. Hence, we performed a systematic search in Google of experiences that could serve as inspiration in terms of products, services and processes to improve access to healthcare services. The search was guided by keywords in Spanish and English: ‘HCD’, ‘cervical cytology’ and ‘healthcare services’. First, we identify the websites to investigate and then we navigate and analyze each site. This search was systematized by means of an evidence matrix; information extracted from the relevant experiences included the following: country, organization/company and a summary of the experience. With this matrix, we entangled discussions with healthcare providers. In the end, we collected insights from the experiences “Generación Más” of the Ministry of Health and Social Protection in Colombia, Diva Centers in Zambia , the Advi. Persona archetypes, ii. Journey maps and iii. Areas of opportunity. The archetypes were fictitious characters built from previous research stage; we defined four archetypes of users of the cervical cytology; uninformed women, fearful women, women with no previous cervical cytology and women adhere to the cancer care program. Journey maps are visual representations of the different moments of interaction of women with the cervical cytology service, which could prove useful to redesign the overall patient experience. In terms of the areas of opportunity, we posed the question “how might we improve access to cytology?” to generate ideas in the next stage.In this stage, we held a multi-stakeholder workshop with the doctor coordinator of the cancer program, the administrator of one of the healthcare centers, the manager of the healthcare network and the design team. This workshop allowed us to validate the topics identified in the previous stage and the results were illustrated in three different forms: In order to synthesize user needs, we used Malterud’s proposal “systematic text condensation” , which iTo ensure data validity and reflexivity, we carry out two types of triangulation . A reseaThe final analysis allowed us to determine five essential needs to consider to improve accessibility to cervical cytology:Strengthen education on cervical cytology and HPV.Promote and offer the use of cervical cytology to women who have never used it.Modify the speculum, perceived as an instrument that causes fear and discomfort.Delay in delivery times of cytology results with risk of loss of women to follow up abnormalities.Harness the time spent by patients in the waiting rooms.The ideation and co-design process was carried out with the participation of both women users of the cervical cytology service and healthcare providers of the cancer program, healthcare center administrators and the general manager of the health network. With this we ensure the balance of power differential during the generation of new ideas. First, we conducted 15 workshops with 9 multi-stakeholder. In these workshops we used multidisciplinary ideation and each participant presented their points of view to propose solutions to the problem posed . In thisFormal data included field notes of the 15 co-design workshops and 8 implementation meetings. Informal data was also gathered, including notes taken from conversations with the community and photographic records during the observation periods.A prototype is an early sample of a product or service before being used in real context . PrototyIn this stage we design four critical prototypes. During a design team workshop prior to in-context testing, we evaluated the viability of their implementation in primary healthcare centers, the usability and alignment between the needs of women in terms of accessibility to cervical cytology and the interests of the healthcare network compared to their goals regarding screening coverage, opportunity and quality of care.After refining each prototype in the previous stage, we tested their usability in the waiting rooms of the healthcare centers, in the community environments of urban and rural areas where these centers are located and, in the laboratory of a simulated hospital. It is important to point out here that we carry out prototyping and context testing in an iterative and participatory way. Each prototype received feedback and the experience was properly tested as we explained below.The following four final prototypes emerged from this process.Given the culture of the city of Cali and the importance of personal image for women, we implemented a first critical-experiential prototype called ‘Encanto’, a free service of educational manicure in the healthcare centers waiting rooms . The expTesting of this prototype included non-participant observation of the interaction between women and manicurists as well as the application of a perception survey to 15 women . The survey contained three questions:What is your opinion of the 'Encanto' experience?How did you find the information provided by the manicurists regarding cytology?After the 'Encanto' experience, what do you think of cytology?Among the responses to this survey we highlight the following:It's rare but cool to find a nail salon here at the hospital. So you don't waste time in the waiting room doing nothing, and it is very good that they give you information about cytology” “The lady who did the manicure showed that she knew of cervical cancer. It is good to share what you think about cytology with another woman. She clarified many things for me that I had not discussed with the doctor for shame. I hope this continues to be done here in the hospital” “Through verification in the health center database and phone calls, we found that of the 15 women who participated in the ‘Encanto’ experience, 12 underwent cytology during the following week; 3 women did not do it arguing lack of time due to childcare.i. in the context of local culture, ‘Encanto’ was an experience valued positively by women, who highlighted taking advantage of the waiting times through education in health; ii. Given that, ‘Encanto’ was oriented to women in poverty-stricken settings, the free nature of the service was key to motivate participation; iii. Its implementation must assure prior training of the staff giving the manicure regarding the prevention of cervical cancer. iv. Finally, due to the appeal of the service, the healthcare center must attend to the demand induced by ‘Encanto’ and schedule Pap test appointments in a timely manner.We analyzed the results of the ‘Encanto’ test in a design team discussion group. Our insights and learnings for subsequent validations of the prototype on a larger scale were: With the purpose of improving accessibility for women that have never taken a Pap test and rarely attend primary healthcare facilities, we conceived the second critical-functional prototype as a media-based strategy called “No le des la espalda a la citología” (‘Do not turn your back on cytology’).This strategy consisted of:A YouTube channel. We launched a campaign using the hashtag #ValePrevenirHoy (It is worth to prevent today) in social networks: Facebook, Twitter and Instagram; in YouTube, we posted an educational video for two months and a half. We obtained 119 visits, exceeding twice the visits of the official channel of the healthcare network in the same period.WhatsApp and Short Message Service (SMS). We floated the video around the internet through WhatsApp and SMS among women with no cytology report. From a database of 9,529 women with a valid cellphone number, 246 messages were randomly sent to users, from which 60% were effectively read. Out of the 200 SMS sent, 98% were read.Bluetooth message through Beacons. Beacons are devices that broadcast messages using a low-cost Bluetooth connection; their focus lies in proximity marketing, which is the wireless distribution of advertising content on a local scale with commercial purposes. We took advantage of this technology and spread the previously mentioned video by placing Beacons in a healthcare network, a central park in the urban area of influence of the healthcare network, and a mobile unit that roamed through rural areas. After analyzing the data, it was determined that, although there were 297 message notifications in the targeted cellphones, few people had effective access to the video.The iterations carried out with this prototype and its results were analyzed by the design team in discussion groups in which the manager of the healthcare network participated. During the iterations we realized the need to refine the educational messages contained in the video, emphasizing the free nature of cervical cytology and consultation without an appointment in all the health centers of ‘Red de Salud Ladera’.i. it is necessary to articulate media strategy to the official communication channels of the Health Network; ii. Of the three media used , reading SMS messaging had a response of 98%, making it the means of communication with the greatest reach in the population studied; iii. in the voice of the manager of the healthcare network, the use of Beacons with preventive messages to promote accessibility to cervical cytology is a low-cost tool, easy to implement, with the potential to reach women quickly and widely in different contexts of daily life and outside health centers. However, these messages should be short, direct and without links to other web sites such as videos. In this regard, the manager commented:Our insights and learnings for larger scale prototype validations were: I'm interested in applying Beacon technology to reach people who hardly ever go to health centers. I can circulate mobile primary care health units to send concrete messages to the community. This would imply that when we arrive at the health centers we ask the women if this type of message reached their cell phones and if that is why they come to cytology” “iv. this prototype led us to conclude that, in order to value the effectiveness of the media-based strategy, a follow-up mechanism must be included that can identify the women outreached with this technology and, subsequently those who visited primary healthcare centers to take a Pap test.Finally, Seeking to optimize time in the waiting room, we designed an educational App embedded into a tablet . This neThe test of this critical experiential prototype was carried out with 40 women , 31 of whom underwent cytology after being exposed to 'Tu Turnero ESE'. Detailed results are presented in i. Harnessing time in the waiting rooms through an educational queuing device was an experience valued positively by women. They no longer considered that they were wasting time that could be spent in taking care of their children or other household chores; ii. The content of the app was appropriate in terms of the average waiting times of healthcare centers; iii. The tablet was not an adequate tool for women over 60 years old, who had difficulty handling a touchscreen. In this regard, we highlight the following statements:We integrated the results of observations, survey and effective use of cervical cytology in a discussion group made up of two women who participated in the experience, three health providers and the design team. Our insights and learnings for larger scale prototype validations were: “It is always good to take advantage of the time while you wait for the doctor to attend you. So one does not feel so guilty about leaving the children at home. I liked the tablet and the survey, it really got me thinking about cytology, I learned things I did not know and so, knowing, cytology becomes easier” “I think the important thing is for women to be aware of their risks. In this sense, if the survey incorporated into the educational Turnero causes cytology to be performed, I consider that we must apply the strategy in all our health centers, especially with women willing to handle the tablet” We initially designed the Citobot  by identifying that the discomfort caused by the speculum can deter women from taking a Pap test. This procedure is often seen as a painful experience, thus reducing the willingness to retake said test. Furthermore, the delivery times of the results varied between 20 to 30 days, significantly delaying the opportunity for subsequent diagnosis and treatment.The Citobot is a critical-functional prototype, designed as an alternative to the speculum and with the intention of detecting precancerous lesions in an immediate manner using an artificial intelligence system. Built using the computer-assisted design (CAD) software SolidWorks, the device uses an endoscopic camera to display images taken from the cervix in real time. We illustrate the design and testing sequence in We performed two types of tests. First, in a simulated hospital with a pelvic Gyn/Aid ® model with different types of cervixes , where the design, camera lighting, resolution and angles of view of the cervix were validated. The test allowed to verify the Citobot operation and compare it with the speculum. It was found to be taking sharp pictures of the cervix. However, the speculum's viewing angle was greater than that of the Citobot, so this device requires further modifications in hardware development. Second, we conducted interviews with 15 women , two doctors, two gynecologists, and two biomedical engineers. The interview with the women explored the general perception of the Citobot and the acceptability for its use. This device is a prototype perceived by women as a promising alternative in comparison to the speculum, turning the Pap test into a more comfortable experience. Doctors and gynecologists valued the huge potential of the device in the reduction of result delivery times and, hence, the rapid detection of precancerous lesions. Comments in this regard were:“The Cytobot is a thousand times better than the speculum! due to its shape, it should be much more comfortable. I don't think there is a woman in this world who likes speculum! this is much better and if it helps to be diagnosed quickly, the better!” .The big problem we have in Cali and I would say that in Colombia in general is the delay in delivering cytology results. If the Citobot allows us to detect precancerous lesions during the consultation and we can refer women immediately to colposcopy to verify the diagnosis, it would be great! I think it has great potential as a medical device to expand screening coverage and that we can effectively prevent cervical cancer mortality” (Gynecologist)“The Citobot , as a poThe artificial intelligence (AI) system works as follows:Image capture: An image of the cervix is captured with the device and sent to the AI system.Image pre-processing: A pre-processing stage is required prior to the analysis, seeking to facilitate the comparison of the image with a previously defined database. This stage corroborates whether the image can be analyzed by the system due to factors such as excessive blurriness, insufficient lighting or a tarnished camera lens.AI-based analysis: The image is processed by the artificial intelligence system, which is trained beforehand using a database comprised of images of cervixes.Preliminary assessment of the level of risk: The AI system determines the level of risk of cervical cancer (low or high) and displays a notification to the healthcare practitioner.The National Department of Science and Technology in Colombia, COLCIENCIAS have benefited Citobot in 2019 for the procedures required by the International Patent System (Patent Cooperation Treaty–PCT).Cancer is a dominant disease worldwide and premature deaths occur specially in low-income and middle-income countries such as Colombia . This arIn other contexts and experiences ,75, HCD Application of HCD in the prevention of cancer in general and cervical cancer in particular has been limited. In 2014, research carried out with executives from payer groups and health care delivery systems, health care providers, and adult patients revealed that this transdisciplinary methodology had not been commonly used for quality improvement efforts in cancer care . In thisOur findings can be partially contrasted with previously used interventions to increase cervical cancer screening from traditional public health approaches. Regarding the ‘Encanto’ prototype: educational manicure, the use of one-on-one education recommended by The Community Preventive Services Task Force  has demoTwo additional elements make ‘Encanto’ an innovative prototype that we would not have achieved using a traditional approach to health education. HCD allowed us to quickly identify two community needs and provide a synergistic solution. First, we detected the poor perception of women about waiting times in health centers, and second, we identified their interest in manicure rooms, which corresponds to the cultural pattern of the city of Cali where women, regardless of their socioeconomic level, prioritize the care of their personal image and beauty. In this way, we decided to bring manicure as a motivational factor to the waiting rooms of health centers. It should also be noted that ‘Encanto’ was an experience test of interest for women in all age groups, unlike, for example, the ‘Cultivating Health’ intervention, where only women who were older than 50 years participated. As our results showed, ‘Encanto’ was an educational experience valued positively by women; however, in the future, both its effectiveness in improving accessibility to the Pap test with larger samples of women and the feasibility of its implementation in the organization of cervical cytology services should be evaluated. Issues like manicure funding, the provision of physical spaces in waiting rooms, and the coordination of waiting times with medical care should be reviewed.Regarding our second prototype ‘Don't turn your back on cytology’: Media-based strategy, our findings also supports the Task Force  recommenRegarding the use of Beacons as health information technology to disseminate our media-based strategy, we did not found previous interventions in cervical cancer screening with which to compare our findings, which represents a limitation for its discussion. The incorporation of the Beacons to the prototype occurred thanks to the HCD methodology with the interdisciplinary conformation of the design team. From a merely traditional perspective of health education we would not have incorporated proximity marketing with Beacons to incentivize the Pap test. The use of this technology is promising to reach women outside of health services in urban and rural settings. Using SMS or Beacons would mean conducting studies that associate message reception with cancer screening behavior. In Colombia, it is also required that healthcare centers are organized in terms of human talent, infrastructure, hardware and software and interoperability between information systems; the country has the potential for this given the expansion of the capacity of telemedicine services that can lead massive prevention campaigns .Our third prototype was ‘Tu Turnero ESE’: Educational wireless queuing device. With this device we achieved the use of time in waiting rooms with cervical cancer prevention education while the women had their turn to be seen by the clinicians. Previous scientific literature has shown that low level of awareness and knowledge about the disease and its early detection are factors that affect the use of Pap tests ,98, and HCD allowed us to achieve two insights during the design of this prototype. First, ‘Tu Turnero ESE’ required that women actively interact with the device. We were not looking for what other authors have already pointed out regarding the passive consumption of health information in waiting rooms . Second,Finally, Citobot is a prototype that began its design to respond to fear of pain, discomfort and embarrassment that vaginal speculum examination produces in women; these factors have been identified as barriers to screening . During Devices similar to Citobot detected in our research stage and benchmarking were: a 'dilating speculum' called the Veda-scope ,108, theAs final thoughts, it is important to recognize that optimizing the provision of cervical cancer preventive services involves complex decision making, multiple transfers between primary care and specialty care providers, and coordination between health service managers and the cancer care team. We must acknowledge that a longer-term evaluation is required to determine whether the prototypes will be used regularly, be integrated into cervical cancer screening services and effectively improve access to cytology. Now, we agree with other authors  that HCDLastly, it is noteworthy to mention that research in HCD has the challenge to include quantifiable results , strengtS1 File(XLSX)Click here for additional data file.S2 File(PDF)Click here for additional data file.