Demand generation activities that were significantly associated with increased use of modern contraception in India (Uttar Pradesh), Kenya, Nigeria, and Senegal included: (1) community outreach activities, such as home visits and group discussions about family planning; (2) local radio programs; and (3) branded slogans and print materials circulated widely across the city. Television programming was also significant in India and Nigeria. Exposure to more activities may increase women's likelihood of using contraception. Demand generation activities that were significantly associated with increased use of modern contraception in India (Uttar Pradesh), Kenya, Nigeria, and Senegal included: (1) community outreach activities, such as home visits and group discussions about family planning; (2) local radio programs; and (3) branded slogans and print materials circulated widely across the city. Television programming was also significant in India and Nigeria. Exposure to more activities may increase women's likelihood of using contraception. Family planning is crucial for preventing unintended pregnancies and for improving maternal and child health and well-being. In urban areas where there are large inequities in family planning use, particularly among the urban poor, programs are needed to increase access to and use of contraception among those most in need. This paper presents the midterm evaluation findings of the Urban Reproductive Health Initiative (Urban RH Initiative) programs, funded by the Bill & Melinda Gates Foundation, that are being implemented in 4 countries: India (Uttar Pradesh), Kenya, Nigeria, and Senegal. Between 2010 and 2013, the Measurement, Learning & Evaluation (MLE) project collected baseline and 2-year longitudinal follow-up data from women in target study cities to examine the role of demand generation activities undertaken as part of the Urban RH Initiative programs. Evaluation results demonstrate that, in each country where it was measured, outreach by community health or family planning workers as well as local radio programs were significantly associated with increased use of modern contraceptive methods. In addition, in India and Nigeria, television programs had a significant effect on modern contraceptive use, and in Kenya and Nigeria, the program slogans and materials that were blanketed across the cities  were also significantly associated with modern method use. Our results show that targeted, multilevel demand generation activities can make an important contribution to increasing modern contraceptive use in urban areas and could impact Millennium Development Goals for improved maternal and child health and access to reproductive health for all. It prevents unintended pregnancies that may lead to abortion, limits the closely spaced and higher-order births most likely to lead to maternal death, and reduces pregnancies that might result in infants being born with HIV infection.,Because of these manifold benefits, family planning is central to reaching the Millennium Development Goals (MDGs), specifically MDG Target 5.B, which is to attain universal access to reproductive health by 2015. This goal will continue beyond the MDG 2015 deadlines; in 2012, the global community launched the FP2020 initiative to reach 120 million new contraceptive users in developing countries by 2020.,–Strong evaluation evidence is needed to inform these country-level family planning strategies. To date, much of the evidence is focused on short-term program outcomes  and on geographically small programs or programs targeting specific groups.,,As the world becomes more urbanized, cities—and slums within cities—are growing rapidly in high-fertility countries, resulting in an increased need to provide family planning and health services in urban settings.The urban poor are less likely to use family planning than their wealthier counterparts.To address the need for family planning in rapidly urbanizing areas, particularly among the urban poor, in 2009 the Bill & Melinda Gates Foundation launched the Urban Reproductive Health Initiative (Urban RH Initiative) in 4 countries: India (Uttar Pradesh), Kenya, Nigeria, and Senegal. The underlying goal of the Urban RH Initiative is to increase modern contraceptive use by 20 percentage points in targeted urban areas, particularly among the urban poor. Each country program aims to meet the following 5 key objectives related to the supply, demand, and advocacy environments:Develop cost-effective interventions for integrating quality family planning with maternal and newborn health, HIV and AIDS, postpartum, and postabortion care programs (supply)Improve the quality of family planning services for the urban poor, with emphasis on high-volume clinical settings (supply)Test novel public-private partnerships and innovative private-sector approaches to increase access to and use of family planning by the urban poor (supply)Develop interventions for creating demand for and sustaining use of family planning among marginalized urban populations (demand)Increase funding and financial mechanisms and promote a supportive policy environment for ensuring access to family planning supplies and services for the urban poor (advocacy)The locally designed programs of the Urban RH Initiative are being evaluated independently by the Measurement, Learning & Evaluation (MLE) project, which is led by the University of North Carolina at Chapel Hill Carolina Population Center in collaboration with the International Center for Research on Women. Findings from the MLE project will inform future family planning and reproductive health programs in the target countries and globally.This article provides a summary of the Urban RH Initiative country programs, focusing on the demand creation activities, along with midterm (2-year) longitudinal evaluation results of the effect of the demand creation activities on modern contraceptive use.In each of the 4 countries, a consortium of local and international organizations have engaged together to increase modern contraceptive method use in target urban sites over the 4 to 5-year project period. India, the Urban Health Initiative (UHI) implemented the following demand creation interventions:In Interpersonal communication activities, including home visits by peer educators (particularly to homes in slum communities) to provide family planning information, counseling, and referral to all women and men as well as to promote long-acting and permanent methods to women who had recently become pregnantRadio and television programs with targeted family planning messages to promote women's control over family planning, men's adoption of sterilization for a happy family, and the importance of long-acting and permanent method use after childbirthSome mid-media activities, including street plays, road shows, and magic shows; these activities are not assessed in this article as they were undertaken predominately in one city with low overall exposureKenya Urban RH Initiative (Tupange) focused on addressing social norms and barriers that inhibit family planning use through:The demand creation activities of the Community mobilization activities including distribution of consortium-developed print materials, such as posters, leaflets, and comic booksJongo Love program, a 24-episode radio drama series set in a fictional urban slum in Kenya, called Jongo, featuring the complex lives and relationships of residents and relating these to the reproductive choices they make. This series aired in Kenya just before implementation of the midterm survey.Mass media activities using focused radio and television shows that targeted the young and poor. For example, one of the Kenya project partners developed the Senegal, the in-country consortium, l'Initiative Sénégalaise de Santé Urbaine (ISSU), implemented numerous types of demand creation activities targeting women and men, such as:In Augmentation of a cadre of community outreach workers who identified family planning needs and counseled and referred women to family planning servicesSmall group discussions on family planning-related topics led by project-engaged midwivesEngaging and training religious and community leaders to become family planning champions and to lead family planning discussions in their local communities and at religious eventsCommunity theater to promote discussions on family planning topics within the community and between the community and religious leadersRadio and television programs aired on local public and private stationsNigerian Urban RH Initiative (NURHI), because it is based on the theory that creating demand for family planning will drive supply and consequently lead to long-term sustainability of program activities, developed numerous demand generation activities that together are thought to influence behavior change. These activities include:The Social mobilization through interpersonal communication activities that encourage discussion about family planning and reduce barriers, myths, miscommunication, and social stigma against family planning. These activities are undertaken at numerous venues such as markets, association meetings, and special events including naming ceremonies, freedom ceremonies, graduation events, Christmas/Eid celebrations, and weddings.Mass media with a particular focus on local and state-level radio programs that promote local-language family planning slogans and messages, radio magazine entertainment-education programs , and television spots that promote the program's family planning messages and slogansProgram brand/slogans/logos were used across program activities (not just on the radio and television) and were also spread to the community through badges worn by health care providers, umbrellas exhibited at the market, posters/displays in health facilities, and t-shirts, bracelets, and other items that were distributed extensivelyThe demand generation activities across the countries had 3 main themes: (1) fostering dialogue about family planning; (2) increasing social approval for family planning; and (3) improving knowledge and perceptions of family planning methods . Not allModel fertility and family planning discussions between couples Model and promote family planning discussions with providers Train religious leaders to discuss family planning in groups and one-on-one Encourage young people to talk to providers and peers about family planning (radio dramas and programs)Promote wider societal discussion of family planning Model healthy and happy families Promote role of family planning in responsible parenting Promote family planning for healthy timing and spacing of pregnancies Develop and focus on one's life goals and family planning's role in achieving those goals Recognize and address reproductive choices of young people, poor people, and women Address potential contraceptive side effects, myths, and misconceptions Promote postpartum family planning use and adoption of long-acting methods Increase knowledge of method choice and sources of methods In each country, the MLE study design involves collecting longitudinal data from a representative sample of women prior to program implementation (baseline), at midterm (2 years after baseline), and at endline (4 years after baseline). In India, Kenya, and Nigeria, the baseline and midterm surveys were conducted in 2010 and 2012, respectively, and the endline survey will occur in 2014. In Senegal, each survey round occurred/will occur 1 year later . This article presents the baseline and midterm longitudinal evaluation results of the demand creation activities.baseline in each country, the MLE project used a 2-stage sampling design to obtain a representative sample of women from each of the initial and delayed intervention cities. In the first stage, for the 3 African countries, representative samples of primary sampling units (PSUs) in project cities were selected based on a sampling frame from the most recent census. In India, where the most recent census was nearly 10 years old, the MLE team developed a sample frame based on geographic location of residence designed to ensure adequate representation of the urban poor and selected a representative sample of PSUs for each study city. , implants, injectables, oral contraceptive pills, emergency contraception, condoms, the Lactational Amenorrhea Method, and other modern methods including spermicides, diaphragms, and the dermal patch, as applicable in each country.For the longitudinal analysis presented in this article, we used slightly different study samples based on country-specific considerations . For exaThis article includes descriptive characteristics of the women interviewed at both time periods for each study country. The main demographic variables included in all multivariate models were age group, education, wealth status, religion, and, for Kenya and Nigeria only, marital status. Wealth group was created within country across cities based on household assets at each time point using principal components methods as done in the Demographic and Health Surveys.The key exposure variables were country-specific variables related to specific program activities encompassing community activities, radio and television programming, print materials, and engagement of religious leaders.All descriptive analyses are weighted using country-specific weights. These weights adjust for uneven probabilities of selection and non-response.Estimation of multivariate models of the impact of women's recall of program exposure on modern contraceptive use by country used samples within which each woman had two observations—one from baseline and one from midterm. Estimation involved random effects logistic regression of an indicator for each woman's modern contraceptive use as of the panel (baseline or midterm) taking into account her background characteristics and program exposure as of that panel. Program exposure was, by definition, zero at baseline in nearly all cases , while for midterm the woman's actual empirically observed program exposure was used. Estimation thus exploited two panels of longitudinal data. Random effects were used to control for the correlation of each woman's observations between baseline and midterm.The longitudinal data and estimation design has several advantages. First, it simply admits more variation in the key variables allowing for generally more precise estimation of the parameters of the model. Second, the longitudinal design also permits examination of the possible endogeneity (sometimes referred to as “confounding”) of the program exposure variables. Endogeneity involves possible correlation between interviewee recall of program exposure and some other unobserved determinants of modern contraceptive use that were not measured in the surveys, with the potential result that estimates of the impact of recall on modern contraceptive use will be biased. There are many potential unobserved determinants that might introduce such correlation , but let us focus on health motivation as an example. If more motivated individuals are more likely to recall program exposure and to use contraception, then the intervening but unobserved motivation variable can lead to a misleading positive relationship between recall of program exposure and contraceptive use. Fortunately, one type of test of endogeneity can be exploited in the longitudinal data setting. The test involves comparison of results from an efficient estimator  that does not correct for possible endogeneity of program exposure (random effects is such an estimator) with a less efficient estimator that does correct for the potential endogeneity of program exposure . Put simply, if the estimates yielded by the two models are similar, this suggests endogoneity is not playing a major role and any observed impact on contraceptive use is likely due to women's recall of program exposure.The study’s longitudinal design has several advantages, namely that it can correct for possible endogeneity (or confounding) of the program exposure variables.Women in Senegal had the least formal education; 43% had no education or only Quaranic education. India had a mixed educational distribution—about a quarter of women had no education (27%) and more than 60% had secondary or higher education. In Nigeria, about three-quarters of women had secondary or higher education, while in Kenya two-fifths had only primary education and more than half have secondary or higher; these relatively high education levels reflect the focus on major urban areas in this analysis.Across the countries, the wealth groups calculated for these urban areas were nearly evenly split; the wealth groups were created as quintiles, so it is expected that about 20% would be in each category.Senegal had the highest percentage of Muslims (94%) of the 4 countries. In Nigeria, about half the population was Muslim, and the remaining half were Christian (Protestant or Catholic). In Kenya, the majority of the women were Protestant (64%); Catholics were the next most common religious group (22%), followed by Muslims (12%). In India, the majority of the women were Hindu (81%), and the remainder were predominately Muslim.Finally, in Kenya and Nigeria , about a quarter were never married, and the remainder were predominately currently in union (63% in Kenya and 66% in Nigeria).In India, more than 40% of women recalled exposure to a UHI television program whereas 23% reported exposure to a community health worker (CHW) and only 5% to a UHI radio program.In Kenya, the most common Tupange demand generation activity known by the women was the print media, comprising the Tupange leaflets (33%) and posters (43%). Among the remaining activities (including the comic book and radio and television programs), between 16%–22% of women reported exposure. Only 11% of women reported exposure to Tupange-led group/club/professional association meetings where family planning was discussed. Notably, in Kenya, the midterm questionnaire did not ask specific questions on exposure to community outreach workers; this oversight will be corrected at endline.In Senegal, more than two-thirds of women recalled exposure to the ISSU television program and more than 40% recalled exposure to an ISSU radio program and a family planning radio advertisement. Close to a quarter of women recalled exposure to community activities (22%) or heard a religious leader speak favorably about family planning (27%).Finally, in Nigeria, radio was a common source of general family planning information (64%), as well as language-specific NURHI radio programs (57%). Likewise, more than half of women reported at midterm that they recalled seeing family planning television advertisements. During the observation period , NURHI was the only group airing family planning messages on television. Among the other NURHI demand generation activities, between 20% and 30% of women were exposed to the logo, slogans, and community events.all women in union surveyed at midterm . At baseline, in the full midterm sample (that includes some women who were sterilized at baseline), the prevalence of modern method use was 49%  as well as the baseline distribution of use among  was 49% . By midtFor Kenya, like India, the aggregate percentage of women using modern contraception between baseline and midterm remained about the same at 45%–46% among women surveyed at baseline and midterm. Use of traditional methods increased slightly between baseline and midterm.In Nigeria and Senegal, modern contraceptive use increased by about 6–7 percentage points between baseline and midterm . Traditional method use changed little in these two countries.Overall, the results of modern method use in The results of the multivariate random effects logistic regression models are presented in figures that show odds ratios (ORs) and their significance for the key program exposure variables by country.  In all countries, the models controlled for age group, education, wealth, religion, and city of residence. In Senegal, the models also controlled for general family planning messages in the mass media but this was not found to be significant. In Kenya and Nigeria, marital status was included in the model since the analysis sample includes women who are in union as well as those who are not . A small number of other country-specific control variables are also included in the models.P ≤ .05) and to any UHI television program  were significantly more likely to be modern method users at midterm than women who did not recall such exposure. While the odds ratio for UHI radio programs is large (OR = 1.32), it was not significant in the random effects models. This may be related to low overall recall of exposure to radio programs, as shown in In India, exposure to UHI television programs was significantly associated with modern method use.P ≤ .05) .In Kenya, exposure to Tupange leaflets and brochures was significantly associated with modern contraceptive use between baseline and midterm  . In addiP ≤ .05) (P ≤ .10). In these results, we did not find an effect of exposure to a religious leader speaking favorably about family planning on women's modern method use. However, in results not shown, when models were run using men's midterm data examining men's method use and attitudes toward family planning, we found that those men who recalled exposure to religious leaders speaking favorably about family planning were more likely to report family planning use as well as to have favorable family planning attitudes than men with no reported exposure to religious leaders (P ≤ .05).In Senegal, women who reported participating in at least one ISSU-supported community activity, comprising a community conversation, a small group discussion, or outreach worker visits, were significantly more likely to be modern method users at midterm than women who did not report participating in any community activity  . This siP ≤ .05) (P ≤ .05). The puzzle logo is used on all types of program materials, including on television, signs at health facilities, posters, and umbrellas. Women who recalled receiving information on family planning at any of the measured community events including association meetings, naming ceremonies, freedom ceremonies, graduation events, Christmas or Eid celebrations, and weddings, were significantly more likely to be modern method users at midterm than women who did not recall participating in these community events . Finally, women who recalled exposure to family planning messages on television in the last 3 months (considered to be NURHI television messages) were significantly more likely to be modern method users at midterm than women who did not recall exposure . A similar effect was found for exposure to general family planning messages on the radio , although this may have included non-NURHI radio activities as well. As noted earlier, the NURHI program has a strong focus on demand generation activities and theorizes that the multiple demand generation activities build upon one another. In results not shown, when women's recall of exposure to demand generation activities are summed, those women who reported exposure to more activities were significantly more likely to be users of modern contraception at midterm than those exposed to fewer activities. This supports NURHI's overall program theory of change. Similar results were found in analyses that summed up the key Tupange demand generation activities .In Nigeria, women who recalled ever listening to local-language NURHI radio programs were significantly more likely to be modern method users at midterm than women who did not recall listening to these radio programs  . In addi–To date, there is little rigorous evaluation evidence of family planning programs targeting urban areas due to difficulties in identifying comparison groups. These findings, which use longitudinal data from women in 14 initial program implementation cities, are a first step in informing future family planning programs in urban settings. Of note are the different study contexts. India and Kenya started at higher levels of modern contraceptive use than Nigeria and Senegal, but the types of contraceptive methods used were different in the countries, particularly among the urban poor. Most poor users in India used female sterilization whereas most poor users in Kenya used injectables.–Several interesting and informative results about demand generation activities emerge from our analysis. First, in each country where community outreach was measured, women who were exposed to community activities were significantly more likely than their counterparts who were not exposed to such activities to be modern method users at midterm. These findings are robust in the sense that models  that explicitly correct for the potential endogeneity of program exposure  offered similar results. In urban settings, it appears that interpersonal communication activities are important strategies for encouraging family planning use. Given that there continue to be a large percentage of women in urban settings that have myths and misconceptions about family planning,Jongo Love program in Kenya and through NURHI's radio magazine entertainment-education programs in Nigeria.Second, local radio programs were also an effective means to encourage women to use family planning. Local radio programs were found to be significant in all 3 African countries but not in India, although the television programs in India that had the same themes (and greater exposure) as the radio programs were significant. Local radio programs were able to address specific concerns of urban, and particularly urban poor, populations as was done through Tupange's Television was also significant in India and Nigeria. In urban Nigeria, there is widespread access to television  that aimed to foster dialogue about family planning. While there appears to have been wide viewership estimated by the program, the activity did not have a significant effect on contraceptive use.Each Urban RH Initiative country program used the results of the midterm evaluation to make midcourse corrections. For example, UHI in India put greater emphasis on CHWs and community outreach activities in slum areas. Also, consortium-led television activities in Kenya and Senegal were dropped while radio programming in Nigeria and Senegal was continued or expanded. In addition to the fact that television programming is expensive, in Kenya and Senegal, reported exposure to television did not have an effect on contraceptive use. In Senegal, ISSU's television program was aired a small number of times on a limited number of television stations but on stations and times that had high coverage. The television programs did lead to high exposure, but they did not necessarily lead to discussion of family planning and to program impacts. On the other hand, the local radio programs that aired numerous times in Senegal were more effective, even with lower overall exposure. In Kenya, the main television program aired, called quality of the CHW (or community event) interactions; this requires more in-depth, qualitative data. Fifth, the information on program exposure is based on respondent recall of family planning programs and messages. It is possible that other women were exposed but were already using family planning or, on the other hand, were exposed but not interested in family planning and thus did not report recalling the messages. Future analyses that examine women's (and men's) ability to recall key messages, intensity of exposure, and length of exposure would be informative for understanding the relationships between demand generation activities and modern method use. Finally, because smaller numbers of women were surveyed at midterm than initially intended, it was not possible to examine the full scope of transitions in modern contraceptive use . The 2014/15 endline evaluation will survey a larger sample and permit a more refined assessment of contraceptive use patterns over time as well as of the association of changes in family planning use with program activities.This analysis is not without limitations. First, because the midterm evaluation was seeking quick results for midcourse corrections, we did not obtain supply side information to determine whether short-term changes in quality and access to family planning may have influenced the results. Second, because we did not collect midterm data in the delayed intervention sites, we lack variation in the exposure variables that comes with comparison sites. Third, from the available data, it is not possible to know whether exposure preceded family planning use or vice versa; thus, the focus of this analysis is on associations rather than on causality. Fourth, the data do not permit an assessment of the Targeted demand generation activities can make an important contribution to increasing modern contraceptive use in urban areas and could impact Millennium Development Goals for improved maternal and child health and access to reproductive health for all. These demand generation activities can be undertaken at multiple levels including community-level activities such as outreach by a health worker, a family planning worker, or a religious leader. Radio programs and, in particular, local radio programs that target key urban populations including younger and poorer groups are also likely to be successful at increasing modern method use.


Infection and sepsis are common problems in cancer management affecting up to 45% of patients. However, international guidelines focus on the management of neutropenic fever, and fail to address the recognition and resuscitation of patients who meet sepsis criteria. Peter MacCallum Hospital is a 100 inpatient-bed tertiary cancer hospital with hematology, medical oncology, cancer surgery and radiation oncology, as well as a medical and chemotherapy day unit, apheresis, and large ambulatory service but no emergency department. Records showed that up to 25% of all in-hospital Medical Emergency Team (MET) calls were attributable to sepsis with in-hospital mortality rates of up to 25%. We aimed to identify barriers to effective management of inpatient sepsis at Peter MacCallum Cancer Centre and to implement a hospital-wide sepsis pathway.A sepsis working party was formed with the antimicrobial stewardship team, clinicians, and senior ambulatory and inpatient nurses. Each member undertook direct observation and focus group interviews in an allocated clinical area. Three key areas were examined: issues relating the identification of sepsis, issues relating to clinical review of the patient, and issues relating to timely administration of first dose of antibiotic. Inpatient and outpatient issues were graphically represented in a process map Figure .Process mapping revealed significant gaps in knowledge in medical and nursing staff and structural barriers to rapid resuscitation of patients. There were significant knowledge gaps in the awareness of sepsis diagnostic criteria, the role of lactate, effective fluid resuscitation, and the need for early clinical review and referral to the ICU. Examples of structural barriers to effective resuscitation included lack of availability of nurse cannulators, availability of antibiotics, rapid intravenous fluid infusers and sufficient after-hours medical and ICU liaison support. Knowledge and structural barriers were systematically addressed during the implementation of the clinical sepsis pathway. The sepsis pathway was designed as a medical record form to be used across all clinical areas, and supports nurse initiation. Following pathway implementation in March 2013 there have been substantial improvements in the number of patients who have had a lactate taken, received appropriate fluid resuscitation and time to first dose of antibiotics. Administrative data shown in Figure Identifying knowledge gaps and structural barriers using process mapping led to the successful design and implementation of a sepsis program. The figures show that despite increased rates of coded sepsis cases, mortality and ICU admission rates have not increased. Mortality of patients coded for sepsis March to October 2012 (13/56 (23.2%)) compared with those for March to October 2013 (10/121 (8.3%)).


A series of recent articles has reported on well-designed studies examining base rates of posttraumatic stress disorder (PTSD) screenings within the Operation Enduring Freedom (Afghanistan conflict)/Operation Iraqi Freedom (Iraq conflict) (OEF/OIF) military population. Although these studies have a number of strengths, this line of research points out several key areas in need of further examination.Many OEF/OIF Veterans do not use available Veterans Affairs (VA) services, especially mental health care. This highlights the need to understand the differences between those who use and do not use the VA, especially as research with pre-OEF/OIF Veterans suggests that these two groups differ in significant ways. The high rates of PTSD-related concerns in non-VA users also points to a need to understand whether—and where—Veterans are seeking care outside the VA and the accessibility of evidence-based, trauma-focused treatments in the community and private sectors. Careful examination of relationship status is also paramount as little research has examined relationship status or other relationship context issues. Social support, especially from a spouse, can buffer the development of PTSD; however, relationship discord has the potential to greatly exacerbate PTSD symptomatology. Furthermore, given the additional risk factors for sexual minority Veterans to be exposed to trauma, the 2011 repeal of the US Military “Don't Ask, Don't Tell” policy, and the emergence of the VA as likely the largest health care provider for sexual minority Veterans, it will be critically important to study the trauma and mental health experiences of this group.Studies that examine prevalence rates of PTSD in the returning cohort contribute significantly to our understanding of the US OEF/OIF military population. Further study of PTSD in relation to demographic variables such as VA and non-VA use, relationship status, and sexual orientation will provide rich data that will enhance our ability to develop policy and practice to provide the best care to this population. A 2014 special issue of this journal focused on posttraumatic stress disorder (PTSD) in the military, highlighting considerable variability in PTSD prevalence rates in epidemiological studies from militaries across the world Castro, . This isAlthough the studies by Dursa et al. and a few others have included both Veterans who use and do not use VA health care, many studies of PTSD prevalence in US Veterans have exclusively focused on Veterans using VA health care. However, many OEF/OIF Veterans do not use available VA services, especially mental health care (e.g., DeViva, Several researchers have started to address how to engage OEF/OIF Veterans in VA care and have shown the utility of using brief motivational interviewing interventions (Seal et al., The high rate of PTSD-related concerns in non-VA users also points to a need for research to understand whether—and where—Veterans are seeking care outside the VA. Only about 60% of returning Veterans are engaged in VA care (Veterans Health Administration [VHA], In addition to studying VA status and looking more closely at non-VA users, it would be useful to examine two further demographic factors in future studies of PTSD prevalence in the OEF/OIF populations: relationship status and sexual orientation. Regarding relationship status, research suggests that social support, especially support from a spouse, can buffer the development of PTSD in trauma survivors in general and Veterans in particular (Dinenberg, McCaslin, Bates, & Cohen, Relatively, few prevalence studies of PTSD in the OEF/OIF populations have examined the association between relationship status and mental health, and those that have have found mixed results. For example, some studies have found no relationship between marital status and PTSD (Riddle et al., Finally, given the 2011 repeal of the US Military “Don't Ask, Don't Tell” policy as well as the emergence of the VA as likely the largest health care provider for sexual minority Veterans (Mattocks et al., Studies that examine prevalence rates of PTSD in the returning cohort contribute significantly to our understanding of the US OEF/OIF military population. Although beyond the scope of this paper, there are likely additional variables that influence the prevalence rates for PTSD in the current cohort of Veterans. For example, concerns have been raised about potential fabrication of PTSD symptoms related to financial incentives within the VA, an issue worthy of careful study (e.g., see Constans et al.,


It is known, that nanoceria interaction with biological systems is based on two principal properties of this substance: low toxicity and high reducibility [The scientific information on biological activity of ceria dioxide nanoparticles  and HSV-1 (DNA-) viruses, the viability We estimated that 1, 25 mM colloid ceria solutions are capable to protect L929 and VERO cells from the damage induced by UV-irradiation , reducinThe application of nanoceria under conditions of involving oxidative stress can reduce / remove its damaging effects, thus providing protecting the organism from adverse environmental factors: UV irradiation, viral, bacterial, fungal lesions induced toxic effects and pathological conditions associated with aging.The biomedical effects of nanoceria offer the prospect of its use as a UV protectant, a drug with antiviral, antibacterial and antifungal activity, as well as means capable of reducing the level of oxidative stress in cardiomyocytes in reproductive organs during aging.


The Centers for Disease Prevention and Control’s National Comprehensive Cancer Control (CCC) Program oversee CCC programs designed to develop and implement CCC plans via CCC coalitions, alliances, or consortia of program stakeholders. We reviewed 40 up-to-date plans for states and the District of Columbia in order to assess how capacity building and sustainability, two evidence-based practices necessary for organizational readiness, positive growth, and maintenance are addressed. We employed an electronic key word search, supplemented by full text reviews of each plan to complete a content analysis of the CCC plans. Capacity is explicitly addressed in just over half of the plans (53%), generally from a conceptual point of view, with few specifics as to how capacity will be developed or enhanced. Roles and responsibilities, timelines for action, and measurements for evaluation of capacity building are infrequently mentioned. Almost all (92%) of the 40 up-to-date plans address sustainability on at least a cursory level, through efforts aimed at funding or seeking funding, policy initiatives, and/or partnership development. However, few details as to how these strategies will be implemented are found in the plans. We present the Texas plan as a case study offering detailed insight into how one plan incorporated capacity building and sustainability into its development and implementation. Training, technical assistance, templates, and tools may help CCC coalition members address capacity and sustainability in future planning efforts and assure the inclusion of capacity building and sustainability approaches in CCC plans at the state, tribal, territorial, and jurisdiction levels. The Centers for Disease Prevention and Control’s (CDC) National Comprehensive Cancer Control Program (NCCPC) fund 65 awardees  in 69 Comprehensive Cancer Control (CCC) programs to develop and implement CCC plans via CCC coalitions, alliances, or consortia of program stakeholders , 2. CCC Centers for Disease Prevention and Control’s NCCPC provide support for CCC Coalitions to develop and implement CCC plans that include approaches to enhance the basic building blocks of CCC : Texas A&M Health Science Center and the University of North Carolina, Chapel Hill. During this period, both institutions were CDC Prevention Research Centers (PRC). The PRCs are CDC’s flagship programs for preventing and controlling chronic diseases. CPCRN provides an infrastructure for applying relevant research to local cancer prevention and control needs. Its members conduct community-based participatory cancer research across its 10 network centers, crossing academic affiliations and geographic boundaries.An online review of 51 CCC Plans  was conducted, utilizing plans posted on the Cancer Control P.L.A.N.E.T.If a state’s plan as posted on the portal was out-of-date, a subsequent search was conducted using state department of health/public health websites and state cancer consortium websites to attempt to identify an up-to-date document for review. Initial scans done in 2012 found 31 of the 51 plans (61%) were current. A follow-up scan done in 2014 found 40 of 51 (78%) up-to-date plans, including 10 plans that were out-of-date in 2012, but updated at the time of the 2014 scan. Nine state plans were out-of-date in 2012 and remained out-of-date in 2014. Two state plans were current in 2012, but outdated in the 2014 scan. See Table This review focused on the specifics of how each plan addressed the community capacity building and sustainability constructs, both of which are critical if planned activities are to be effectively implemented and maintained throughout the plan’s timeline. The National Council of Non-profits notes that distinct capacity-building projects such as identifying a communications strategy, improving volunteer recruitment, developing a leadership succession plan, identifying more efficient uses of technology, and engaging in collaborations with community partners all contribute to building capacity .Other definitions of capacity include R. J. Chaskin’s description in the Urban Affairs Review, “Community capacity building is the interaction of human capital, organizational resources, and social capital existing within a given community that can be leveraged to solve collective problems, and improve or maintain the well-being of that community” . GoodmanMeasuring Community Capacity Building similarly notes that community capacity building is viewed as building durable resources within a community or organization. It involves a combined influence of a community’s commitment, resources, and skills that can be deployed to build on community strengths and address community problems and opportunities  of organizations that was convened regularly . In some cases, such as Virginia, collaboratives met more frequently. Monitoring and updating each plan seem to be the responsibility (either implicitly stated or implied) of each state collaborative.The majority of the plans were developed through a committee process, often with sections developed by work groups  whose members have specific expertise related to the specific section of the CCC plan. These sections are combined into the comprehensive plan.The organization of the plans varies across states with some plans structured to address the cancer continuum as well as site-specific cancers and others, focused solely on site-specific cancers. Plans varied widely in their level of detail, with some including extensive state cancer data, which can serve as a resource for reference by those interested in cancer statistics within a particular state while others simply summarized goals, objectives, and strategies.Capacity is referred to in 21 of the 40 up-to-date plans (53%) although it is generally addressed only from a conceptual point of view, with few specifics as to how capacity will be developed or enhanced, roles and responsibilities specified, timelines for action enumerated, or measurements for evaluation of capacity building delineated. Table ∙District of Columbia: this plan takes the step of providing a budget breakdown for plan implementation, which includes a $75,000 line-item for coalition member technical assistance and capacity building.∙Florida: the Florida plan includes an overarching component on capacity, which lists 10 specific strategies for capacity building.∙Michigan: the importance of capacity is highlighted in the plan’s guiding principles: “Cancer control priorities should be established based upon capacity for collaborative partnerships among public health agencies, private organizations, cancer centers, and all other interested agencies and organizations to carry out recommended cancer control activities.”∙Nebraska: a memorandum of understanding developed between the Nebraska Cancer Coalition and the Nebraska CCC Program is featured in the plan’s introduction. This document outlines the relationship and respective roles and responsibilities of the two entities as well as joint roles and responsibilities. The intention is for the relationship to be seamless while at the same time enhancing Nebraska’s capacity to maintain a state-wide partnership, develop, and implement a state cancer plan and meet the overall goal of reducing the burden of cancer in Nebraska.∙South Carolina: a specific capacity building goal is included in South Carolina’s plan: “To increase the effectiveness of our cancer prevention and control activities by ensuring adequate resources such as high quality data, funds, and an educated work-force, as well as effective allocation of these resources.” Contained within this cross-cutting goal are goals and strategies related to human resources, information services, and financial resources.∙Texas: five principles are outlined in the plan’s introduction, which includes defining measurable and realistic targets based on review of a baseline and trend data for cancer prevention and control key measures, with consideration of factors such as available resources, barriers, and capacity for implementation of strategic actions.∙Utah: a strategic prevention framework model addressing capacity building and partnership creation is included in the plan, which states, “Creating and implementing a comprehensive strategic plan to control cancer requires diverse perspectives and resources. Health care providers, oncology specialists, researchers, cancer survivors, advocates, public health professionals, insurers, and employers all need to be involved in the process. The makeup of each workgroup, as well as the state-wide coalition, should reflect multiple perspectives.”∙Additionally, Utah’s model raises the following questions based on the Substance Abuse and Mental Health Services Administration’s (SAMHSA) five-step public health planning process: (1) assess population needs, resources required, and readiness to act; (2) build capacity; (3) develop a comprehensive plan; (4) implement evidence-based programs; and (5) monitor implementation, evaluate effectiveness, sustain effective activities, and improve or replace those that fail . Other k∙Vermont: the Vermont plan also references SAMHSA’s public health planning model just noted, with step 2 relating to capacity building.Despite the widespread lack of details that consider “who,” “how,” and “when,” a number of plans did consider capacity building with some detail. Noteworthy examples include:Almost all [37 (92%)] of the 40 up-to-date plans address sustainability at least on a cursory level, through seeking funding, developing policy initiatives, and/or pursuing partnership development. Table ∙California: sustainability related to health disparities includes recommendations to provide capacity building, technical assistance, and resources to sustain local efforts; expand federal and state funding for services related to reducing disparities, especially in areas identified as gaps; assist local coalitions in identifying outside private funding sources.For site-specific cancers, the California plan notes (prostate cancer) support funding for research to identify better screening tools and develop treatment options; (breast cancer) support research and grants for clinical trials, state and federal funding for access to screening and diagnosis, private funding and grants for uninsured and under-insured people;  develop and promote clinical standards and professional education materials that promote follow-up and treatment for abnormal screening tests and support funding for state and federally funded programs.Advocacy is identified as a tool that can help educate public, healthcare professionals, and policy makers to garner support for funding; participate in media advocacy efforts.∙Connecticut: the Connecticut plan notes, “This 4-year plan does not address implementation funding issues directly. Focusing on policy, systems, and environmental (PSE) changes provides a sustainable high-impact approach to health improvement efforts. We charge all organizations to take an active role, working collaboratively to leverage support for implementation and to move forward, using this blueprint as a consensus-based guide for resource allocation.”∙District of Columbia: sustainability is a cross-cutting theme through the D.C. plan with references to identifying and seeking funding.∙Massachusetts: the plan notes the importance of developing and sustaining collaborations to reduce cancer-related health disparities and promote health equity; creating and sustaining a cancer policy and legislative agenda that supports projects across the continuum; and creating and sustaining environments that support prevention.Details on how sustainability is addressed in several of plans are noted:Texas Cancer Plan, the state-wide blueprint for cancer prevention and control in Texas“Organizations, institutions, community leaders, planners, coalition members, cancer survivors, and family and friends affected by cancer from across the state have come together to help develop and implement the The plan was developed by the Cancer Prevention and Research Institute of Texas (CPRIT) with state and CDC funding, which supported the engagement of a professional facilitator and also covered meeting costs. While CPRIT has statutory responsibility for facilitating the development of the CCC plan and supporting its implementation, the overall outcome and success of the plan depend on the cooperation, collaboration, and resources of the many stakeholders throughout the state (p. 2).The planning process benefited from the involvement of several planning group members who had been involved in the development of previous Texas plans as part of the Cancer Alliance of Texas, a state coalition funded through the CDC. Members without previous CCC prevention planning experience in Texas contributed valuable planning and technical expertise into the process.In addition to the work of the planning group members, feedback, and comments on the draft content of the Texas plan was sought from community stakeholders including state legislators, members of government-based organizations, industry, and educational and cancer advocacy groups. This important step facilitated meaningful stakeholder input and community buy-in, which in essence lead to community capacity building.Defining measurable and realistic targets based on review of a baseline and trend data for cancer prevention and control key measures, with consideration of factors such as available resources, barriers, and capacity for implementation of strategic actions.Developing or strengthening infrastructure supporting the delivery of cancer prevention and care services.Advocating for funding for tobacco control, obesity prevention and control, nutrition and physical activity recommendations, epidemiologic and environmental monitoring and research, survivorship programs to improve quality of life, and infrastructure supporting collection of quality cancer data and delivery of cancer prevention and care.Promoting funding opportunities across the spectrum of cancer research.The principles outlined in the plan’s introduction include:Principles one and two support the construct of capacity building, while three and four support sustainability.primary prevention and risk reduction ;screening and early detection ;diagnosis, treatment, and palliation ;quality of life and survivorship ;infrastructure ;research and commercialization .The Texas plan is organized around six priority areas, within which 16 goals are outlined. Experts in the field of cancer prevention and control and public health selected the priority areas based upon review of cancer trends, health disparities, and available evidence-based strategies. If implemented in systematic and comprehensive ways, these priority areas will have a significant impact on the human and economic cancer burden in Texas. Capacity building and/or sustainability are either explicitly or implicitly mentioned in most priority areas and their supporting goals and action statements. The priority areas are:In terms of capacity building, the Texas plan is effective in engaging community partners at multiple levels. Training and communications strategies (key capacity-building tools) are identified in many of the plan’s goals. As an example, goal 1 of primary prevention is to reduce the incidence and mortality from lung cancer and other tobacco-related cancers. This goal includes several capacity-building actions: improving professional knowledge, practice behaviors, and systems support; development of state-wide messaging campaigns; and implementation of evidence-based strategies for tobacco control.While not a part of the plan document, CPRIT, which administers $3 billion in funding for cancer research and prevention programs in Texas, requires organizations submitting proposals for funding to detail which goals and objectives their proposals support. The Cancer Alliance of Texas also requires organizations seeking support letters for CPRIT proposals to identify explicitly how their proposals address the plan goals and objectives. These processes build both capacity and bridges to sustainability.Advocacy activities and funding strategies are found throughout the plan. These approaches are intended to support efforts to sustain the plan’s proposed activities. The Texas Department of State Health Services (TXDSHS), which administers the CDC funding for cancer control in Texas, also supports regional cancer coalitions in order to further achieving the Texas plan’s objectives. The Cancer Alliance of Texas is collaborating with CPRIT and TXDSHS in an evaluation and assessment of the plan due for publication in mid-2015.The next Texas CCC plan will be developed in 2016. Groundwork is already being laid to support both capacity building and sustainability through activities to reach broader audiences, link organizations engaged in advocacy activities, engage more businesses, and more actively engage social media.This review adds to a growing literature assessing the content of CCC plans and their incorporation of evidence-based cancer prevention and control practices , 16. AltWhile community capacity building is not explicitly discussed in the majority of the plans, it is implicit throughout most of the documents through goals, objectives, and strategies that relate to activities including the need for partner organizations to work collaboratively. Training, a vital element in community capacity building , is mentioned in multiple plans. As an example, the Maryland plan addresses training of professionals, patients, and caregivers in several sections of the document. The New Mexico plan similarly addresses the need for medical professional training, especially in cultural competencies related to tribal communities and older populations.Public policy or advocacy is addressed in almost all of the plans, either as a stand-alone section or as objectives or strategies supporting goals. Efforts related to public policy or advocacy generally relate to capacity building as well as sustainability and are undertaken by non-governmental CCC coalition members and/or member organizations.Some plans are including a section outlining what can be done by groups or individuals such as professional organizations, employers, schools and universities, faith based organizations, physicians, legislators, and citizens. At a macro level, this might be considered capacity building, although there is little in the way of how these lists might be put into action beyond dissemination of the plans.In considering sustainability, ongoing funding is usually a paramount factor, yet the 2005 Review of Comprehensive Cancer Control Plans notes, “Few plans identify funding sources. A few plans describe specific committees or groups charged with identifying or securing funding” . SeveralIn plans including objectives or strategies for funding or support of funding, the majority of these objectives or strategies are included in, but not necessarily limited to, the tobacco prevention sections of the CCC plans. A conclusion might logically be drawn that committees/work groups made up of individuals with extensive long-term experience in tobacco control issues may have more experience in strategies and activities that support funding for public policy and advocacy. Alternatively, it is likely state Tobacco Funds are frequently one of the few sources available to the CCCs other than the CDC funds.As CCC coalitions undertake CCC plan revisions and develop new CCC plans, they might be encouraged to include sections that clearly outline both capacity building and sustainability, as well as specifics regarding roles, responsibilities, and methods for monitoring and evaluation adherence to evidence-based principles –19.In recent years, we have seen a proliferation of dissemination and implementation models that are just beginning to be incorporated into cancer prevention and control research. Models such as the RE-AIM model , 21 or tThis report is limited to a content review of current state plans. An initial limitation is that there may have been more current plans that the investigators were able to identify due to posting requirements. For identified plans, community capacity and sustainability constructs may have been addressed in both the planning process and as part of the implementation process, although absent in the plans themselves. Yet, we would argue that giving salience to these concepts in the CCC plan itself is important for establishing credibility and legitimacy to public health processes for building community capacity and achieving sustainability.“Currently, there is no prescribed or standardized format for CCC plans. Thus, plans vary in organizational structure, length, and level of detail.” Attempts to identify and examine how capacity and sustainability were addressed remain difficult since there is not a standard method or metric available for states to use in addressing these constructs or to objectively assess how well these constructs are dealt with on a state-by-state basis. Because of their critical importance in effective planning, a framework or outline for how and where to address capacity building and sustainability, as well as how to evaluate them, would be useful to state CCC coalitions.Similarly, the use of key word and nomenclature searches to scan plans is helpful, but limiting. As noted in the 2005 review, because many plans use words that differ from those used in a “key word scan,” activities related to capacity building and sustainability might have been missed, even with the added step of a time-consuming read-through of each plan.Limitations reported in the 2005 CCC plans: a content review  can esseBased on this review, the following recommendations are made. These are segmented into recommendations for the Center for Disease Control and Prevention (CDC) Division of Cancer Prevention and Control and for state cancer control consortiums.∙Provide clear and easy to understand definitions of both community capacity building and sustainability for collaboratives to use in their planning process;∙Review the Guidance for CCC Planning Volume 1: guidelines and models and language to better assist states in addressing sustainability and capacity issues in their plans;∙Address community capacity building and sustainability constructs through orientations, training, and tools that can be used by CCC Coalitions ;∙Promote best practices by recognizing and highlighting those plans that are specific in addressing community capacity building and sustainability;∙Offer training (online and/or at meetings) related to community capacity building and sustainability related to concrete methods to include these in the planning process;∙Encourage use of planning templates by states in order to save time and better leverage resources. These templates, which can be modeled from examples of plans or portions of plans that might be considered “best practices,” can address a variety of cross cutting issues including capacity and sustainability. Use of templates can free state planners from developing processes and formats, and allow them to spend more time on the important content of their plans.For CDC Division of Cancer: Prevention and Control, NCCPC∙Stipulate that each group that works on a section or sections of the CCC plan should include specific steps for how capacity building and sustainability will be addressed. Or address capacity building and sustainability as stand-alone cross-cutting topics within the plan.∙Review other state plans to see how both sustainability and capacity building are addressed, and replicate quality processes as appropriate.∙ad hoc manner, or as members of the CCC coalition).Include experts in capacity building and sustainability processes in the planning process (either in an ∙Utilize tools and resources available from CDC related to capacity building and sustainability.∙Request training and technical support for development of capacity building and sustainability strategies within plans.For state CCC coalitions:We are hopeful that there may be greater attention to these key concepts as recent CDC funding opportunities have encouraged the development of sustainability efforts . FurtherThe ability of a plan to be carried out is reliant on the capacity of the organization or organizations responsible for implementation, and also the availability of resources to sustain the work of the plan. CCC plans must address both community capacity building and sustainability in a concrete and realistic manner to assure the success of the important work being undertaken by cancer control and prevention agencies and by associations engaged in the planning process.MO and CM conceived the original study, advised on overall research design, and advised on analysis plan and write-up. BS conducted the content review and drafted the manuscript. DVD contributed to the case study and provided a critical review of drafts.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Working in humanitarian crisis situations is dangerous. National humanitarian staff in particular face the risk of primary and secondary trauma exposure which can lead to mental health problems. Despite this, research on the mental health of national staff is scarce, and a systematic analysis of up-to-date findings has not been undertaken yet.This article reviews the available literature on trauma-related mental health problems among national humanitarian staff. It focuses on the prevalence of selected mental health problems in relation to reference groups; sex and/or gender as predictive factors of mental health problems; and the influence of organization types on mental health problems.Three databases were systematically searched for relevant studies published in the English language in peer-reviewed journals.Fourteen articles matched the inclusion criteria. Findings suggest that national staff experience mental health problems and the prevalence of posttraumatic stress disorder, depression, and anxiety among this occupation group is mostly similar to or higher than among reference groups. Research on both substance use disorder and suicidal behavior among national staff is particularly scarce. The relation between sex and/or gender and mental health problems among national staff appears to be complex, and organizational staff support seems to be an important determinant for mental health.All findings call for increased attention from the humanitarian community and further research on the topic. Working in humanitarian crisis situations is dangerous and staff are increasingly at risk  of humanitarian workers operating in the field are national staff  or other mental health problems , and anxiety disorders, which are recognized as further important posttrauma disorders and the most common comorbid conditions of PTSD ,” “international NGO,” and “intergovernmental organization.” Organizations of the same type can be diverse but typical disparities between organization types, such as proximity to the epicenter of crises and different staff support strategies, seem to be particularly relevant in predicting mental health problems: front-line responders, for instance from Red Cross/Red Crescent Societies and national NGOs, experience a disproportionally high number of the attacks against civilian aid operations , two examined expatriate and national staff  and four centered on national staff and refugee volunteers (3), national staff, firefighters and student volunteers (4), national staff and disaster-unexposed nurses (11), and national staff and student volunteers (14), respectively. Eleven articles used quantitative methods to assess mental health problems (1–11), two applied a qualitative design , and one study a mixed-method approach (14).All quantitative studies used self-report questionnaires to screen for symptoms of mental health problems, whereby the questionnaires differed between studies. Further, assessments took place at different points in time during or after assignment and trauma exposure. Nine studies and the quantitative part of the mixed-method research applied a cross-sectional design , one study followed a retrospective cohort design (10) and one examined mental health problems at three sequenced post-disaster time points (9). One qualitative study used a case report format (12) and one conducted semi-structured interviews (13). The qualitative part of the mixed-method research relied on focus group discussions (14).Research took place in China , Guatemala (14), India (8), Indonesia (9), Iran (4), Jordan (3), Kosovo (6), Pakistan , Sri Lanka (5), Sudan (7), and Uganda (1). All articles were published between 2005 and 2013.Ten studies quantified PTSD. Prevalences range from 6.2% among local Kosovar Albanian staff who scored symptoms concordant with PTSD diagnosis (Lopes Cardozo et al., While most studies did not present prevalence rates for reference groups, four did. Lopes Cardozo et al.  found thSeven articles assessed the prevalence of depression. Rates range from 4% moderate levels among Indonesian Red Cross volunteers (Thormar et al., Anxiety prevalences of national staff were presented in five studies: 53% of national staff from Uganda scored levels for high risk for anxiety disorder (Ager et al., SUD and suicidal behavior were each analyzed by one study. Only 2.5% of Kosovar Albanian staff were engaged in hazardous alcohol consumption while 16.2% of expatriate workers drank at hazardous levels (Lopes Cardozo et al., Seven studies focused on sex and/or gender differences of mental health. Most studies investigated “sex” but used the term “gender.” Results are presented using the terminology applied in the studies.In the study of Ager et al.  on staffThormar et al.  found thWang, Yip, et al.  includedThree articles presented results on the organization type their study participants worked for and its significance in explaining mental health problems. In their sample of Sri Lankan national staff, Lopes Cardozo et al.  disaggrepost hoc suggest that the fraction of national NGO staff showing clinically relevant depression symptoms was similar to that of international NGO staff and significantly higher than that of staff working for the UN and related organizations.National staff from Uganda who participated in the study of Ager et al.  were empEriksson et al.  collectePTSD was the most commonly assessed outcome in the articles included in this review, followed by depression and anxiety. It stands out that the prevalence for these mental health problems varies greatly between studies. Caution needs to be applied in comparing these results given their generation with different assessment tools (Dominici, Levy, & Louis, Other key factors explaining the diversity of PTSD, depression, and anxiety rates include that research took place in different geographic locations and cultural contexts. Previous studies found symptoms, interpretation, and response to anxiety disorders and depression to vary widely across the globe and the research points to a relationship between country-specific PTSD rates and value orientation (Burri & Maercker, It may be important that some staff responded to natural and others to man-made disasters. While both have much in common, former research suggests that psychological consequences of man-made disasters may persist longer than those caused by natural ones (Solomon & Green, Nonetheless, a certain pattern emerges: the results suggest that PTSD, depression, and anxiety exist among national staff. Where studies reported prevalence rates in reference groups, national staff appeared to be similarly or more affected. This observation deserves attention, as organizations have the moral obligation to prevent and address mental health problems among their staff, ensure their well-being, and sustain organizational effectiveness and efficiency IASC, . The onlGiven the strong comorbidity of PTSD and SUD reported in the literature, it is surprising that SUD was only examined by one study Breslau, . ResearcSuicidal behavior was also assessed by one study only. This is surprising given that exposure to traumatic events has been associated with an increased risk of suicidal behavior, specifically among military and veteran populations Knox, . While gMost studies concluded that female staff reported more symptoms of common mental disorders than men, in line with the literature and research on other population groups in the respective geographic and cultural context (Ager et al., It is surprising that some studies found sex and/or gender to be an insignificant predictor for mental health outcomes. Lopes Cardozo et al.  offer anWhile these explanations seem plausible they also have weaknesses. Firstly, the argument of Thormar et al.  does notThe ambiguous results indicate that the relation between sex and/or gender and mental health problems among national staff is complex, and specific research on this particular occupation group is needed. Qualitative research would help clarify the characteristics of men and women working in the field of humanitarian aid as well as gender-specific cultural peculiarities and roles. Further, a differentiated use of the concepts “sex” and “gender” is required to avoid confusion Afifi, .Very few studies put a specific focus on the organization type and its impact on mental health. In part, this can be explained by the fact that some studies focused on staff from one organization only or from different organizations of the same type. The two studies that discussed this predictor in greater detail are consistent in their finding that the type of organization had no influence on PTSD development, but working for an international NGO was associated with higher levels of depression symptoms (Lopes Cardozo et al., While only a couple of studies focused on the organization type, a more detailed analysis of the reviewed literature reveals that specifically components related to staff support did still receive extensive attention. For instance, Hagh-Shenas et al.  did not This article reviewed the available literature on trauma-related mental health problems among national humanitarian staff. The subject appears to be under investigated. Only a restricted number of articles could be included, which is a limitation of this study. Another limitation lies in the compromised comparability of research findings due to a lack of standardization in this branch of mental health research. The impossibility to draw conclusions regarding the causal relationship between trauma exposure and mental health problems is another key limitation of this article. This is due to the methodological nature of the studies reviewed.Although only 14 studies fulfilled the inclusion criteria and despite all other limitations, this literature review provides fundamental information for aid workers, organizations, and researchers. Firstly, up to date findings suggest that national staff experience mental health problems and that the prevalence rates of PTSD, depression, and anxiety among this occupation group are mostly similar to or higher than those of reference groups. Secondly, research on both SUD and suicidal behavior among national staff is particularly scarce. Thirdly, ambiguous findings suggest that the relation between sex and/or gender and mental health problems among national staff is complex. Fourthly, the association between organization type and mental health problems is rarely studied but organizational staff support appears to be an important determinant.These findings call for increased attention of the humanitarian community and further research on the topic. Longitudinal studies are urgently needed to validate the causality of relationships. A more harmonized approach towards research on mental health problems, as might be defined by the Inter-Agency Standing Committee reference group, would be desirable to allow for easier comparison of results and to facilitate the formulation of general conclusions and recommendations. Finally, more mixed method and qualitative research would help to answer open questions and investigate cultural patterns and specifics in greater detail.


To review existing regulations and policies utilised by countries to enable patient access to orphan drugs.A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country.Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country’s legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country’s pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access.Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases. Orphan drugs are medicines or vaccines intended to treat, prevent or diagnose a rare disease. Examples of rare diseases include genetic diseases, rare cancers, infectious tropic diseases and degenerative diseases. The definition of rare diseases varies across jurisdictions but typically considers disease prevalence, severity and existence of alternative therapeutic options. In the United States (US) rare diseases are defined as a disease or a condition which affects fewer than 200,000 patients in the country   of cost-Availability and access to medicines are important to reduce morbidity and mortality of rare diseases. For instance, until the recent availability of pirfenidone, a lung transplant was the only treatment option for patients with idiopathic pulmonary fibrosis, a rare disease with a 50% chance of survival at 3 years . DespiteIt is important to understand regulatory and policy initiatives for orphan drugs that exist in countries and their differences to improve research and policy development for treatment of rare diseases. However, existing articles in this field predominantly either summarized regulations and policies in a single country or continent, or discussed the effect of a single or few regulations/policies influencing access to these important medicines. The aim of this study was to review, as comprehensively and systematically as possible, the range and types of existing legislations, regulations and policies that are utilised by countries to enable the availability and accessibility of orphan drugs.The PRISMA guidelines for conducting systematic reviews were followed – for relevance. Subsets of research results were checked by a second author (ZB or CYL). If there was any ambiguity with regards to the paper, the full-text article was retrieved and reviewed for relevance. After removing duplicates and titles/abstracts unrelated to orphan drugs or rare diseases, we identified 113 peer-reviewed, English-language articles. We included original articles, reviews, commentaries and opinions if they described legislations/regulations/policies for orphan drugs and relevant health services. Of these, only 58 articles were relevant to legislations/regulations/policies for orphan drugs; thus these articles were read in full by TG, with guidance from ZB and CYL. Six more articles were identified from references of the retrieved articles; thus 64 articles were considered against our study inclusion and exclusion criteria with no significant bias found that would affect the cumulative evidence reported . Based oWe reviewed the literature systematically to ensure that a narrative synthesis produced was sourced from the most complete collection of relevant literature possible. Thematic analysis of the articles was conducted, with the addition of new regulation/policy categories as needed, and relevant sub-categories created for examination until no more themes were identified and saturation was deemed to be reached. Using regulation/policy categories generated by this analysis, we described the range and types of legislation/regulation/policy in each included country that affect the availability and access to orphan drugs.Availability of orphan drugs was defined as whether an orphan drug had obtained a relevant marketing authorization (and orphan designation if necessary) [Access to orphan drugs was defined as the enabling of individuals in their financial and physical ability to obtain and receive relevant care involving orphan medicines. Access was commonly determined by coverage status, reimbursement, and price [For the purposes of this review, availability of and access to orphan drugs were each defined as follows. cessary) . Access nd price .The included 57 articles involved 35 countries (21 EU countries and 5 Asian countries); these included the US, Canada, Europe, Australia, Taiwan, Singapore and Japan. We did not find any reporting legislations/regulations/policies for orphan drugs in Latin America and African countries. We noted that there had been few original articles (22 of 57) in this field. Our review of the 57 articles generated 6 themes with 13 subcategories. Themes included national orphan drug policy, orphan drug designation, orphan drug marketing authorization, marketing exclusivity, incentives, pricing and reimbursement. These themes describe the political or regulatory mechanism utilised and the relevant influence with regard to patient access to orphan medicines. National Orphan Drug Policy was one of the 6 themes identified from our review and included: orphan drug legislation, national rare disease plans, cross-border regulation, and orphan drug designation.Orphan drug legislation is used by a number of countries to encourage research, development and marketing of orphan drugs , 31, 42.It is important to note that patient advocacy was instrumental in the formation of orphan drug legislation such as the US Orphan Drug Act and EU regulation (CE) N°141/2000 . PatientNational plans for rare diseases have a general purpose to create a regulatory framework for access to services, treatment, and information, research stimulation, and patient advocacy , 43, 46.The EU is unique in that it is the only entity to have a centralised procedure for orphan drug designation and marketing approval extending across its member countries. Cross-border regulation is of particular importance in the context of rare diseases because patients often do not receive treatment due to inadequate access to orphan drugs as well as inadequate availability of related specialised clinicians and facilities domestically . The dirOrphan designations are often based upon: severity  and unmet need  , 47. ThiAssessment for marketing authorization of orphan drugs has been critical in promoting the availability of orphan medicines and is often the same as those for non-orphan medicinal products in non-EU countries , 39, 41.Some countries have accelerated procedures to ensure timely availability of orphan drugs to the market , 4. ThesThere are financial and non-financial incentives to ensure availability and access to orphan drugs. We summarize these below.Financial incentives utilised worldwide include: research grants, tax credits/corporate tax reductions, marketing exclusivity, and user fee waivers , 42, 49.Non-financial incentives we identified include: fast track approval, pre-licensing access (in the form of compassionate or off-label access) and scientific advice, that is, free protocol assistance and/or development consultation , 10, 29.Marketing exclusivity is generally implemented as part of a package of incentives to encourage pharmaceutical companies in research and development of orphan drugs. This allows firms several years to recover costs for drug development. During the marketing exclusivity period, regulatory agencies cannot approve a generic drug or brand name drug for the same rare disease indication , 31. HowMarketing exclusivity exists as a strong incentive for development of orphan drugs worldwide. However, there are concerns regarding monopolisation and the manufacturers’ high prices for orphan drugs . This isPricing of orphan drugs is often referred to as ‘black box’ pricing due to the lack of literature on orphan drug pricing mechanisms , 30. PriFixed pricing, adopted by many EU countries and other countries such as Japan and Canada, often involves two methods. The first is reference pricing, whereby a country compares the price requested by the manufacturer with the price in other countries . CountriCoverage and reimbursement of orphan drugs have been widely regarded as the most important determinant of patient access to orphan medicines , 53, 54.Health Technology Assessment (HTA) is often utilised to assess the value of medicinal products, including orphan drugs , 55, 56.While orphan drugs often do not meet traditional cost-effectiveness criteria, they may be reimbursed by payers in some countries because other factors are taken into account in reimbursement decisions . These iAdditional considerations by countries can also often include “rule of rescue”  and equity of access. “Rule of rescue” and equity of access criteria are often considered in Canada and Israel for orphan drugs . Common Proposed HTA solutions for orphan drugs include ‘multi-criteria decision analysis’ that considers measures of: rarity, clinical effectiveness, level of research undertaken, level of uncertainty around effectiveness, manufacturing complexity, follow up measures, disease severity, available alternatives and budget impact. Healthcare resources are then allocated on the basis of the performance of the drug against these criteria until the associated budget is consumed .Access to orphan drugs may be affected by considerable patient co-payment or coinsurance , which aClinical evidence requirements at the time of orphan designation and marketing approval may be relaxed if post-marketing surveillance programmes are used. These mechanisms are often utilised to enable early approval and access to drugs for a serious or life-threatening illness. These programmes are in place to ensure that if clinical efficacy requirements are not reached, the drug will no longer be provided , 59–62. Managed entry agreements (MEAs) are being increasingly utilised worldwide as ‘innovative reimbursement approaches’ to fund high cost (orphan) drugs. These require the manufacturer to enter into an agreement with the payer involving negotiations of performance targets based on expectable health improvements. These schemes are utilised as an alternative approach to provide coverage with restrictions for drugs that may not otherwise be covered . MEAs ofPerformance-based schemes aim to provide security of cost-effectiveness and link performance to reimbursement of (orphan) drugs. These schemes can provide reimbursement with an assurance of post-marketing clinical evidence and surveillance . If perfThis article reports a comprehensive literature review of legislations, regulations, and policies used in 35 countries to enable the availability of and access to orphan drugs in the last two decades. Existing reviews in this field predominantly either summarized rare disease and orphan drug regulations and policies in a single country or continent, or discussed the effect of a single or few regulations/policies influencing access to these important medicines. The breadth and depth of our review provides important understanding and appraisal of the topic. We summarized the wide range of legislations, regulations, and policies that influence access to orphan drugs on an international scale and examined similarities and differences in legislations/regulations/policies between countries. We identified 6 major types of regulations/policies each with subcategories.We included 21 countries from the EU. Orphan drug designation, marketing authorization and 10 year marketing exclusivity are common to EU countries. We also noted key differences between the 35 countries included in the review. Differences in pricing and reimbursement policies and budgetary considerations across countries may result in inequities in access to orphan drugs , 22, 27.Overall, the majority of countries (27 of 35) included in this review have in place orphan drug legislation (either independent legislation or legislation as part of the EU) but only 18 countries had established a national plan for rare diseases and orphan drugs. This is likely because a country having established national orphan drug legislation may not require a national plan. It is also possible that national plans are less prevalent because they are at the discretion of the individual country while national legislation for orphan drugs in EU countries is governed by EU regulation (CE) N°141/2000 . CountriThe EU, US, Japan, Taiwan and Australia all have in place independent pathways for marketing authorization of orphan drugs. In these countries orphan drugs tend to meet criteria for accelerated procedures based upon unmet need or disease severity. Accelerated procedures can shorten marketing authorization timeframe almost by half but countries vary in the implementation of accelerated marketing authorization procedures , 10, 29.Financial and non-financial incentives are commonly used, with only 9 of 35 countries found to have no financial or non-financial incentive of any kind for orphan medicines. A common challenge for many countries is the inability to adequately implement proposed incentives for orphan drugs due to budgetary constraints , 22, 27.Access to orphan drugs continues to be limited by high prices. Fixed pricing schemes are common across the countries in the review (16 of 35 countries). However, fixed pricing models are not without limitation; price fluctuations may be explained by international purchasing power parity differences , 26, 27.Reimbursement of orphan drugs is probably the most important factor determining patient access to orphan drugs given their high costs , 20, 50.Patient co-payments in some countries such as the US and Canada pose significant barriers to patient access as well as high acquisition costs of orphan drugs , 4, 10. Managed entry agreements are an innovative and increasingly used approach to enable access to high cost orphan and non-orphan drugs in situations where there is a lack of sufficient evidence for coverage of promising technologies that may benefit patients –60, 63.While many developed countries such as the US, Japan, Australia, and EU countries have established a range of legislations/regulations/policies for orphan drugs, many Asian countries fall behind. A few Asian countries such as Japan, Singapore and Taiwan have made developments in this area. In particular, Taiwan reimburses 70% to 100% of the cost of orphan drugs for low income families under the Rare Disease Prevention and Medicine Law by the Department of Health/ Bureau of National Health Insurance . HoweverOur study has some limitations. First, publication and outcome reporting bias may have led to the publication or non-publication depending on the nature or direction of the findings . InvestiOverall many countries have undertaken a combination of regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of regulations and policies implemented. The presence of marketing exclusivity remains critical to incentivising research and development of orphan drugs but poses risks, most notably monopolisation and high prices for orphan drugs, which may limit patient access to these needed medicines. Importantly, China and India that each has populations in excess of one billion individuals, lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.S1 Appendix(DOC)Click here for additional data file.S2 Appendix(DOCX)Click here for additional data file.S3 Appendix(DOCX)Click here for additional data file.S4 Appendix(DOCX)Click here for additional data file.