Community-based Institutions Research Articles

Challenges optimizing the after visit summary

BackgroundThe after visit summary (AVS) is a paper or electronic document given to patients after a medical appointment, which is intended to summarize patients’ health and guide future care, including self-management tasks. ObjectiveTo describe experiences of health systems implementing a redesigned outpatient AVS in commercially available electronic health record (EHR) systems to inform future optimization. Materials and MethodsWe conducted semi-structured interviews with information technology and clinical leaders at 12 hospital and community-based healthcare institutions across the continental United States focusing on the process of AVS redesign and implementation. We also report our experience implementing a redesigned AVS in the Epic EHR at the Mount Sinai Hospital in New York City, NY. ResultsHealth systems experienced many challenges implementing the redesigned AVS. While many IT leaders noted that the redesigned AVS is easier to understand and the document is better organized, they claim the effort is time-consuming, Epic system upgrades render AVS modifications non-functional, and primary care and specialty practices have different needs in regards to content and formatting. Our team was able to modify the document by changing the order of print groups, modifying the font size, bolding section headers, and inserting page breaks. Similar to other health systems, our team found that it is difficult to achieve some desired features due to limitations in the EHR platform. ConclusionHealth IT leaders view the AVS as a valuable source of information for patients. However, limitations to AVS modifications in EHR systems present challenges to optimizing the tool. EHR vendors should incorporate learning from healthcare systems innovation efforts and consider building more flexibility into their product development.

Sea turtles support sustainable livelihoods at Ostional, Costa Rica

AbstractOstional in Costa Rica is the second largest nesting site of the olive ridley sea turtle Lepidochelys olivacea, which is categorized as Vulnerable on the IUCN Red List. In Ostional the local community helps maintain the nesting site and collects olive ridley eggs for consumption and trade within Costa Rica. Since its inception in 1987 the egg harvesting project has integrated sea turtle conservation with community development. We assessed the current status of this project in terms of community awareness, dependency, involvement and perceptions, using a household survey and semi-structured interviews with key informants. We also compared some of our findings with those of previous studies at the site, finding that the project has fewer dependents, primary livelihood activities have shifted towards tourism and hospitality, and respondents are more aware about environmental conservation and stewardship. We map outcomes of the project with the Sustainable Livelihoods Framework, and suggest that further capacity building for research and tourism could contribute towards sustaining the turtle population, local livelihoods, and the community-based conservation institution.

Is There a Difference in Staging and Treatment of Head and Neck Squamous Cell Tumors Between Tertiary Care and Community-Based Institutions?

ObjectiveTo characterize the differences in the staging and treatment of patients with head and neck squamous cell carcinoma between a tertiary care center and community‐based practices.MethodsThis study is a retrospective chart review of 943 adult patients with head and neck squamous cell cancer presenting to a tertiary care center between 2008 and 2014 as part of the University of Michigan Head and Neck Cancer Specialized Program of Research Excellence (UM HN‐SPORE) database. Demographic information, diagnostic testing, staging information, and treatment recommendations were recorded.ResultsOf 943 patients reviewed, 159 had documentation of tumor stage that was assigned by the community‐based practice. Of these, 53% had a tumor staging change made at the tertiary care center, with 43% of patients upstaged and 10% of patients downstaged. Fifty‐one percent received different treatment than had previously been offered at the community‐based practice, although only 31% of these patients had a change in tumor staging.ConclusionOver half of patients with head and neck squamous cell carcinoma who are evaluated at a tertiary care center after the initial evaluation at a community‐based practice have their tumors staged differently, with the majority upstaged. A significant number of these patients also received different treatment than was initially offered at the referring practice. Future studies are required to determine whether these differences have an effect on tumor recurrence and patient survival rates.Level of Evidence2c (Outcomes Research).

Community dialogs on the probabilities of community-based mangrove institution

Active community participation is necessary for sustainable mangrove management. This two-year qualitative cum action research immersed into the context of a mangrove community in Krabi, Thailand with a three-fold purpose: (1) to understand the momentum of community roles in mangrove management over the past seven decades, (2) to devise a dialogic learning process for the community to create a community-based institution (CBI) for mangrove management, and (3) to identify the internal factors that influenced the probabilities for the community to realize their desirable CBI choice. The results revealed that the relations of the studied community to the local mangroves were oriented toward utilization, competition, exclusion, incentive-driven participation, and underground management. To empower their self-management capacity, a dialogic process entitled the Learn-to-Institutionalize Commons Management Model (L-ICM) was devised for the community to review their socio-ecological relations, to self-elevate their consciousness of the necessity for collective management, and to expose them to self-organizing experience. The community drafted three village mangrove rules and attempted to integrate them into a tambon mangrove rule. The factors that influenced the probabilities for the community to realize a genuine CBI for mangrove management included both foundation and procedural factors. The community dialogs must be founded on a deep awareness of the socio-ecological relations, high consciousness of the necessity of joint management, and clear understanding of the principles of commons management. They must continue in order to promote the community residents’ deeper and wider recognition of the benefits of institutional changes and adequate background knowledge for a systematic self-organization for pro-active and transparent mangrove management. Dialog facilitators working in lagging parts of the community were recommended to expand from smaller neighborhood dialogs instead of village dialogs.

Pesantren: Lembaga Pendidikan Berbasis Masyarakat (Tinjauan Pasal 1 ayat 4 PP Nomor 55 T ahun 2007 Tentang Pendidikan Agama dan Pendidikan Keagamaan)

Pesantren is one of the religious education institutions that have gained trust from the people of Indonesia. The position of pesantren as an educational institution, also received government recognition, as mentioned in article 1 verse 4 of PP No.55 of 2007 on Religious Education, that Pesantren or Islamic boarding school is a community-based Islamic education institution. The concept of community-based education at its core is education from society, by society and for society. The study of this article is viewed from the aspect of law, religion, education, social and culture. In addition, the function of PP No.55 of 2007 is expected to not only be a function that is only written in the rules, but also applicable in the implementation. The existence of PP No.55 of 2007 really brings benefits, especially here in the development of pesantren as one form of community-based education institutions.

The role of community-based livestock management institutions in the adoption and scaling up of pigeon peas in Malawi

Although decades of research show long-duration pigeon peas (PPs) as a best-bet technology that enhances nutrition, soil fertility, crop diversification, food security, climate-change resilience, agroecological sustainability, and incomes of resource-poor smallholder farmers in Saharan Africa (SSA), PP adoption remains low. This exploratory qualitative study examines obstacles to PP adoption and their relative importance, strategies used to protect PPs from livestock damage, and the conditions that shape the emergence and effectiveness of Community Based Livestock Management (CBLM) arrangements to prevent PP damage. We conducted focus group discussions, participatory rural appraisal (PRA), and key-informant interviews in five communities at different levels and duration of PP adoption, and used theoretical insights from agrarian political economy. Livestock damage was the biggest obstacle to PP growing in new PP sites; poor markets and production factors dominated in the established sites. Individual crop-protection strategies were often time-consuming, costly, and/or ineffective. While chief-based livestock-management systems protected all crops satisfactorily during the rainy season, they were insufficient to protect PPs during the dry season. CBLM arrangements controlled livestock damage and protected PP relatively effectively throughout the year. Implemented only at the relatively established PP-growing sites, CBLM arrangements were most effective at the site (Mpokwa) where PP prices were good and markets reliable, PP was the top or major cash crop, PP growers were powerful and in the majority, and institutions pre-existed for use in CBLM. The findings lead to the following hypothesis: smallholder farmers are likely to invest time and energy in collective livestock-management approaches to prevent damage to pigeon peas when expected economic benefits of adoption exceed perceived costs for most growers, mediated by socioeconomic differentiation and power relations among major stakeholders. Future research should empirically examine determinants of CBLM emergence for PP protection and scale-up.

Abstract A16: Invisible men: Men of color in health disparities research

Abstract Purpose: As the 21st century has brought a myriad of newfound discoveries for cancer researchers, the inclusion of men of color in this research remains minimal. It is as if men of color are invisible in these discussions and gaps in health disparities widen even as survivorship and treatments expand for other populations. The new focus on precision medicine has created stronger emphasis on expanding the research ideas currently being discussed and examined. The new protocol focus for immunotherapy and use of genetic biomarkers has transformed cancer research because of its ability to create innovative cellular models for cancer cell development. New Methodologies Needed: Clinical trials continue to contain disproportionate representation of African American participants, and yet the gaps that exist within mortality rates and survivorship remain lower among African American participants. The health care/cancer research arena reports outcomes that are satisfactorily accepted as reasonable measures of cancer strategies and outcomes. The significant question is whether these outcomes measures are valid in their findings due to inadequate representation of some groups who are identified as most vulnerable from nonsatisfactory cancer outcomes. Summary: The development of programs targeted toward under-represented populations and evaluation of communications strategies to assess the effectiveness of such programs to improve health outcomes is essential to diminish disparities. The purpose of this report is to evaluate the effectiveness of a community education program and initiative to highlight health disparities among high-risk populations. The Men of Color Health Awareness (MOCHA) initiative has been in existence since 2010 in Springfield, Massachusetts; since its inception it has reached almost 1,000 men of color in educational settings, and some 400 men have participated in its exercise and empowerment programs. MOCHA has been a key player in providing health information and interventions to men of color. Activities include hosting a prostate cancer symposium, recruitment for free PSA screenings, digital story-telling documentation, ongoing participation in community activities, and focusing on domestic violence. MOCHA plays a key role with academic institutions and health organizations in gathering information about health disparities that exist among men of color. Conclusions: A utilization of community-based programs that focus on minority populations can represent an effective strategy and approach to communicate with special populations--particularly as it relates to clinical trials education, recruitment, and accrual. Community-based organizations and faith-based institutions that contain men of color in key leadership roles and positions build trust within the community and may improve accrual and retention in clinical trials research. MOCHA has a Program Coordinator and Outreach Coordinator in key positions and decision-making processes. Men of color remain critical players to include in any outreach approaches. Minority groups will attend educational programs and respond with actions if encouraged by representatives who resemble their population. African Americans will support programs with research focuses and find information beneficial to their overall health. Community-based research is possible and inclusive of real-world experiences. Citation Format: Antonio Delesline, Sanford Earl Jeames. Invisible men: Men of color in health disparities research [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr A16.

Abstract 4524: Immunohistochemistry and alternative FISH testing in breast cancer with HER2 equivocal amplification

Abstract PURPOSE While HER2 testing is well established in directing appropriate treatment for breast cancer, a small percentage of cases show equivocal results by IHC and FISH. Alternative probes may be used in equivocal cases. We present a single community-based institution's experience in further evaluating these cases. PATIENTS AND METHODS Between 2014-2016, 4255 samples were submitted for HER2 amplification testing by alternative probes, TP53, RAI1, and RARA. Of patients tested by FISH, 505/3908 (12.9%) also had IHC data. RESULTS Most (73.9%) FISH equivocal cases remained equivocal after IHC testing. Duplicate testing by IHC using a different paraffin block resulted in poor reproducibility as 44% of IHC negative became equivocal and 40% of IHC equivocal became negative. Of the equivocal cases by IHC, 52.3% became positive by alternative FISH. However, 50.5% of cases equivocal by conventional FISH were classified as HER2 amplified by alternative probes. Most cases were positive by more than one probe; 78% of positive cases were positive by RAI1 and 73.9% by TP53. There was a significant difference between IHC and FISH alternative testing (P<0.0001) among the equivocal cases by conventional FISH testing, 44% of IHC negative cases became positive while 36% of the positive IHC cases became negative by alternative FISH testing. Available data showed that 41% of patients were treated with palbociclib and were positive by alternative FISH. CONCLUSION The prevalence of double HER2 equivocal cases and the discrepancy between IHC and alternative FISH testing suggest that FISH alternative testing using both RAI1 and TP53 probes is necessary for conclusive classification. Due to the significant difference between IHC repeat testing, reflexing on IHC alone in this group of cases may not be reproducible. Because almost half of FISH equivocal cases converted to HER2 amplified upon alternative testing, clinical studies to determine benefit of anti-HER2 therapy in these patients is urgently needed. Alternative FISHIHC Score 0 NegativeIHC Score 1 NegativeIHC Score 2 EquivocalIHC Score 3 PositiveNo%No%No%No%Negative1463.65454.517847.7436.4Positive836.44545.519552.3763.6Total22100.099100.0373100.011100.0 Citation Format: Sally Agersborg, Christopher Mixon, Thanh Nguyen, Sramila Aithal, Forrest Blocker, Lawrence Weiss, Robert Gasparini, Shiping Jiang, Wayne Chen, Gregory Hess, Maher Albitar. Immunohistochemistry and alternative FISH testing in breast cancer with HER2 equivocal amplification [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 4524.

Educational Management of Educational Institutions In Limitation’s State

Junior High School Based Pesantren (SMPBP) Mutiara Bangsa is an implementation of community-based management model developed by the government as one alternative in dealing with border education issues, both educational issues due to the characteristics of the border areas themselves, as well as problems related to the education of child’s Indonesian Migrant Workers (TKI) who have not met national education policy expectations and MDGs commitments.
 The focus of this study is the management of integrated educational management of public education units with religious education units; the educational role of existing an educational institution in Sebatik Nunukan North Kalimantan, as a community-based educational institution that supports government programs and helps tackle educational issues in border areas. 
 This study uses the Case Study method, through data collection through participatory observation, in-depth interviews, and documentation and data analysis as used by K. Yin.
 Research result titled Educational Management of Educational Institutions in Border Areas, Case Study at Junior High School- Based Pesantren Mutiara Bangsa Sebatik Nunukan District. First, Mutiara Bangsa education institution is the right alternative in the border area to fulfill the hope of increasing human resources of society, the form of strategic government policy, and indirectly maintain the integrity of Indonesian workforce. Second; the nation's education institution implements the function of planning, organizing, actuating and controlling as well as in other educational units, but there are differences in the handling of the child of Indonesian Migrant Workers, Third, the Mutiara Bangsa’s education institution has a strategic role in the border area as a container of government program implementation, National defense; realizing character education, providing educational services in 3T areas and an alternative education for Childs Indonesian Migrant Workers

Academic Service and Student Satisfaction: A Case Study on Sekolah Tinggi Agama Islam Negeri Teungku Dirundeng Meulaboh – Indonesia

Sekolah Tinggi Agama Islam Negeri (STAIN) Teungku Direundeng Meulaboh is a community-based educational institution. Established in co-operation with the Aceh Barat District Government management authority Indonesia, STAIN will fulfil the quality services of students in all the programs it offers. Academic service is an activity or a series of the activities that occur due to interaction between the students and the staff provided by the service of the campus that aims to solve the students’ problem. In this study a qualitative method is employed to explore the important aspects related to the implementation of the academic services and administration in STAIN Teungku Dirundeng Meulaboh and the students’ satisfaction of the services quality provided by STAIN Teungku Dirundeng Meulaboh. The results found that the level of compliance of academicians to the regulations stipulated by STAIN Teungku Dirundeng Meulaboh to students’ quality services was not been optimal. The results also revealed that some of the lecturers provide the worth service by not attending classes on a time and sometimes missing the classes. Almost all aspects of service quality that include empathy, reliability, and responsiveness are not optimal. To maintain a healthy atmosphere and academic quality is necessary to develop services to the students, especially the indicators are considered the most important by students who expected to create the academic services dynamic and innovative.

Enhancing Religious Education: An Attempt to Counter Violent Extremism in Indonesia

Indonesian government plays an important role in developing religious education. Since the 1970s, the government has promoted basic education for the Indonesian citizen, modernizing primary and secondary education and including religious subjects in the national curriculum. Furthermore, from the early beginning of the New Order era, Islamic educational institutions such as pesantren and madrasah—which are mostly founded by private or informal institutions— must also follow the national curriculum and comply with state regulations. On the one hand, pesantren is continuously recognized as an autonomous institution, and honored as a community-based educational institution. Madrasah, on the other hand, is supported to teach Islam and religious subjects, but at the same time it is required to introduce sciences and general subjects to its students.During the 1980s and 1990s, major changes in the curriculum of Islamic religious education in Indonesia have turned madrasah into education institutions increasingly integrated in Indonesia’s national education. In fact, the share of general studies reached 70%, while religious studies have been reduced to only about 30% of madrasah curriculum. As a consequence, all madrasah graduates have equivalent degree recognized by other schools in general, enabling them to pursue undergraduate studies in public universities.DOI: 10.15408/sdi.v25i1.7284

Immunohistochemistry and alternative FISH testing in breast cancer with HER2 equivocal amplification

PurposeWhile HER2 testing is well established in directing appropriate treatment for breast cancer, a small percentage of cases show equivocal results by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). Alternative probes may be used in equivocal cases. We present a single community-based institution’s experience in further evaluating these cases.Patients and methodsBetween 2014 and 2016, 4255 samples were submitted for HER2 amplification testing by alternative probes, TP53, RAI1, and RARA. Of the patients tested by FISH, 505/3908 (12.9%) also had IHC data.ResultsMost (73.9%) FISH equivocal cases remained equivocal after IHC testing. However, 50.5% of equivocal cases were classified as HER2 amplified by alternative probes. Most cases were positive by more than one probe: 78% of positive cases by RAI1 and 73.9% by TP53. There was a significant difference between IHC and FISH alternative testing (p < 0.0001) among the equivocal cases by conventional FISH testing, 44% of IHC negative cases became positive while 36% of the positive IHC cases became negative by alternative FISH testing. Available data showed that 41% of patients were treated with palbociclib and were positive by alternative FISH.ConclusionThe prevalence of double HER2 equivocal cases and the discrepancy between IHC and alternative FISH testing suggest that FISH alternative testing using both RAI1 and TP53 probes is necessary for conclusive classification. Because almost half of FISH equivocal cases converted to HER2 amplified upon alternative testing, clinical studies to determine the benefit of anti-HER2 therapy in these patients are urgently needed.

Legal Literacy Village (Building Legal Awareness for Access to Justice for Citizens in Bendan, Kergon, Pekalongan)

&#x0D; Islamic Boarding School or generally called Pondok Pesantren (Ponpes) is a community-based educational institution of Islamic religious education that organizes an integrated religious education with other types of education. Ponpes must be able to compete with other general educational institutions by conducting a management. In 2018, Indonesian government issued the accounting guidelines of Ponpes which mainly aimed at empowering economic of Ponpes in order to be able to prepare financial statements. The public volunteers of Economics Faculty of UNNES conducted services at Ponpes Aswaja (Semarang) which had not yet had good financial management. The recording of financial data such as santri’s tuition fee was still manual and the payment recapitulation still used folio books untidily. Consequently, it is difficult to find if the recapitulation is required for accountability. Therefore, it is necessary an integrated financial management system of Ponpes in order to record the financial data properly. The system can also facilitate Ponpes to carry out financial transparency and accountability in accordance with financial accounting standards. The voluntary activities focused on the understanding of Aswaja Ponpes administrators regarding accounting and financial management based on information technology called Sistem Manajemen Keuangan Pondok (Sikepo). The activities were implemented by training and mentoring of administrators based on Participatory Rural Appraisal (PRA). Ponpes administrators were enthusiastic about Sikepo training. Sikepo could improve the understanding of accounting and financial management of Ponpes administrators. Furthermore, the system was then used to record every financial transaction in Ponpes. The final of financial statements were the recapitulation of student tuition fee, the use of funds for daily needs, and other activity reports. This system can also be used in all Ponpes over Indonesia.

Sikepo: Santri Empowerment In Managing Pondok Pesantren Financial To Make Transparency And Accountability

Islamic Boarding School or generally called Pondok Pesantren (Ponpes) is a community-based educational institution of Islamic religious education that organizes an integrated religious education with other types of education. Ponpes must be able to compete with other general educational institutions by conducting a management. In 2018, Indonesian government issued the accounting guidelines of Ponpes which mainly aimed at empowering economic of Ponpes in order to be able to prepare financial statements. The public volunteers of Economics Faculty of UNNES conducted services at Ponpes Aswaja (Semarang) which had not yet had good financial management. The recording of financial data such as santri’s tuition fee was still manual and the payment recapitulation still used folio books untidily. Consequently, it is difficult to find if the recapitulation is required for accountability. Therefore, it is necessary an integrated financial management system of Ponpes in order to record the financial data properly. The system can also facilitate Ponpes to carry out financial transparency and accountability in accordance with financial accounting standards. The voluntary activities focused on the understanding of Aswaja Ponpes administrators regarding accounting and financial management based on information technology called Sistem Manajemen Keuangan Pondok (Sikepo). The activities were implemented by training and mentoring of administrators based on Participatory Rural Appraisal (PRA). Ponpes administrators were enthusiastic about Sikepo training. Sikepo could improve the understanding of accounting and financial management of Ponpes administrators. Furthermore, the system was then used to record every financial transaction in Ponpes. The final of financial statements were the recapitulation of student tuition fee, the use of funds for daily needs, and other activity reports. This system can also be used in all Ponpes over Indonesia.

Linking Agriculture and Natural Resource Management towards Nutrition Security (LANN+).

The multisectoral Linking Agriculture, Natural Resources and Nutrition (LANN+) approach is centered around family nutrition and has an explicit focus on integrating nutrition sensitive sectoral elements that address underlying and basic causes of malnutrition to achieve nutrition security. Based on the UNICEF causal framework of malnutrition, LANN+ focuses on the linkages between agriculture, water sanitation and hygiene, natural resource management, income, market, and nutrition. In Welthungerhilfe implemented programs in India, LANN+ seeks behavior change through the "Participatory Learning and Action" methodology, using a rights-based approach, focusing on women's empowerment and strengthening of both community-based institutions as well as local government functionaries for long-term sustainability.

The King Midas Monoculture

The King Midas Monoculture

Perceptions of Citizen Affiliated with Community Based Institutions on Social Norms and Practices Related Adolescent Sexual and Reproductive Health in Baitadi District of Nepal

The study attempted to explore and analyze perceptions of citizens affiliated with Community Based Institutions on social norms and practices related to adolescent sexual and reproductive health in Baitadi district of Nepal. The objective of this study was to assess social acceptance level of citizen to challenge prevailing social norms and their readiness to abandon unhealthy traditional practices related to sexual and reproductive health as a social accountability. Descriptive and analytical research design was used to take the citizens perspectives. A total of 337 respondents affiliated with the five different types of Community Based Institutions (CBIs) were interviewed using structured questionnaire for data collection and data analysis was done by using SPSS version 16.0. The findings of the study revealed that majority of citizens were sticky on traditional social norms and practices. Majority of citizens were not agree to allow adolescent girls to go to school during mensuration, to allow to stay inside home during mensuration and talking about sex and sexuality between parents and adolescents. Therefore, there is a need of social norms change and step up for positive social deviant by citizen leaders to promote enabling social environment for adolescent sexual and reproductive health.Dhaulagiri Journal of Sociology and Anthropology Vol.11, 2017; 151-163

Can forest stand alone? Barriers to the restoration of the last remaining rainforest in Assam, India

This study assesses the causes of forest resource depletion in the Poba reserve forest, Assam, India. Although many activities, such as hunting and grazing, are banned, the Poba reserve forest is being degraded. The results of a household survey show local communities have experienced a decrease in forest resources in 2012 compared to 2002. Lack of community-based institutions and proper forest management plan has opened access to the forest, resulting in illegal logging and over extraction of forest products. These activities have limited the ability of Poba reserve forest to deliver ecosystem goods and services, and prevented forest restoration. Change is forest cover and availability of forest products has adversely affected the livelihoods of more than two-thirds of local households. The study suggests that participatory involvement of local communities in forest management can reverse trends in deforestation and forest degradation and restore the ecosystem. The forest cannot stand alone; it needs active support of the local community.

Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial

ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings. In this ongoing randomised, double-blind, placebo-controlled, phase 3 trial, eligible women aged 18 years or older (≥20 years in Japan) with stage 1-3c (modified to stage 2-3c in February, 2010) operable breast cancer, who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab with no evidence of disease recurrence or metastatic disease at study entry. Patients who were eligible patients were randomly assigned (1:1) via permuted blocks stratified according to hormone receptor status (hormone receptor-positive vs hormone receptor-negative), nodal status (0 vs 1-3 vs or ≥4 positive nodes), and trastuzumab adjuvant regimen (given sequentially vs concurrently with chemotherapy), then implemented centrally via an interactive voice and web-response system, to receive 1 year of oral neratinib 240 mg/day or matching placebo. Treatment was given continuously for 1 year, unless disease recurrence or new breast cancer, intolerable adverse events, or consent withdrawal occurred. Patients, investigators, and trial funder were masked to treatment allocation. The predefined endpoint of the 5-year analysis was invasive disease-free survival, analysed by intention to treat. ExteNET is registered with ClinicalTrials.gov, number NCT00878709, and is closed to new participants. Between July 9, 2009, and Oct 24, 2011, 2840 eligible women with early HER2-positive breast cancer were recruited from community-based and academic institutions in 40 countries and randomly assigned to receive neratinib (n=1420) or placebo (n=1420). After a median follow-up of 5·2 years (IQR 2·1-5·3), patients in the neratinib group had significantly fewer invasive disease-free survival events than those in the placebo group (116 vs 163 events; stratified hazard ratio 0·73, 95% CI 0·57-0·92, p=0·0083). The 5-year invasive disease-free survival was 90·2% (95% CI 88·3-91·8) in the neratinib group and 87·7% (85·7-89·4) in the placebo group. Without diarrhoea prophylaxis, the most common grade 3-4 adverse events in the neratinib group, compared with the placebo group, were diarrhoea (561 [40%] grade 3 and one [<1%] grade 4 with neratinib vs 23 [2%] grade 3 with placebo), vomiting (grade 3: 47 [3%] vs five [<1%]), and nausea (grade 3: 26 [2%] vs two [<1%]). Treatment-emergent serious adverse events occurred in 103 (7%) women in the neratinib group and 85 (6%) women in the placebo group. No evidence of increased risk of long-term toxicity or long-term adverse consequences of neratinib-associated diarrhoea were identified with neratinib compared with placebo. At the 5-year follow-up, 1 year of extended adjuvant therapy with neratinib, administered after chemotherapy and trastuzumab, significantly reduced the proportion of clinically relevant breast cancer relapses-ie, those that might lead to death, such as distant and locoregional relapses outside the preserved breast-without increasing the risk of long-term toxicity. An analysis of overall survival is planned after 248 events. Wyeth, Pfizer, and Puma Biotechnology.

The influence of community-based resource management institutions on adaptation capacity: A large-n study of farmer responses to climate and global market disturbances

Abstract An underlying understanding among adaptation and community-based natural resource management (CBNRM) scholars is the existence of important feedbacks between local resource management institutions and individual adaptive capacity. The relationship between CBNRM and individual adaptive capacity is of global concern given the ubiquity of CBNRM worldwide, the patent impacts of global changes at local levels, and the recent calls for the integration of climate and rural development policies. So far, however, there have not been formal, large-n studies of that relationship. This study aims to fill that gap by testing whether the performance of community-based water management institutions and communal land regimes have an impact on the effectiveness of farmers’ adaptation responses to climatic and global market disturbances. For this purpose, the study relies on a unique dataset of individual and collective features obtained from water user associations (WUAs) and ejidos in Mexico. According to the regression results, well-functioning community-based water management institutions have a positive and significant impact on individual farmers’ self-reported response effectiveness. The impact of communal land property is also significant but negative. These effects, which hold only in the context of climate disturbances but not market disturbances, can be explained by looking at the support given by the associations to farmers, and issues of communal land marginalization, respectively. Policies that strengthen the autonomy and capacity for cooperation of WUAs and ameliorate structural deficits in communal land regimes shall not only guarantee a long-advocated path for rural development but also help farmers deal with some of the climatic uncertainties that increasingly threaten agriculture.