Resource-stratified Guidelines Research Articles

6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7)

This manuscript describes the Advanced Breast Cancer (ABC) international consensus guidelines updated at the last two ABC international consensus conferences (ABC 6 in 2021, virtual, and ABC 7 in 2023, in Lisbon, Portugal), organized by the ABC Global Alliance. It provides the main recommendations on how to best manage patients with advanced breast cancer (inoperable locally advanced or metastatic), of all breast cancer subtypes, as well as palliative and supportive care. These guidelines are based on available evidence or on expert opinion when a higher level of evidence is lacking. Each guideline is accompanied by the level of evidence (LoE), grade of recommendation (GoR) and percentage of consensus reached at the consensus conferences. Updated diagnostic and treatment algorithms are also provided. The guidelines represent the best management options for patients living with ABC globally, assuming accessibility to all available therapies. Their adaptation (i.e. resource-stratified guidelines) is often needed in settings where access to care is limited.

Longitudinal Costs of Image-Guided Intensity-Modulated Radiation Therapy Versus Three-Dimensional Conformal Radiation: Lessons From Phase III PARCER Trial for Shaping Resource-Stratified Guidelines in Low- and Middle-Income Countries.

The PARCER trial provided level I evidence for image-guided intensity-modulated radiation therapy (IG-IMRT) in patients with cervical cancer. Further information regarding long-term financial impact is imperative for adoption into the National Cancer Grid of India cervical cancer resource-stratified guidelines. Patient data from the PARCER trial were analyzed to evaluate the cost implications of transitioning to IG-IMRT. Lacking differences in outcomes between the three-dimensional conformal radiation (3D-CRT) and IG-IMRT, differences in treatment costs, adverse event incidence, and toxicity management costs were examined. The overall financial impact was estimated by adding the treatment costs, toxicity management, and wage loss. This was extrapolated nationally to determine if a transition to IG-IMRT would be feasible for the Indian health care system. Of the 300 patients in the PARCER trial, 93 faced grades ≥2 adverse events (3D-CRT = 59, IG-IMRT = 34). Patients in the 3D-CRT and IG-IMRT arms spent an average of 2.39 years and 1.96 years in toxicity, respectively. The average toxicity management and the yearly financial impact per patient were, respectively, 1.50 and 1.44 times higher for 3D-CRT patients compared with IG-IMRT patients. Extrapolation to the national level showed that treatment with 3D-CRT led to a 2.88 times higher cost ratio when compared with treatment with IG-IMRT. Although the initial costs of IG-IMRT are high, on the basis of longitudinal data, it is financially inefficient to treat with 3D-CRT. Resource-stratified guidelines should include longitudinal health intervention costs rather than solely initial costs for policy decisions to implement advanced radiation technology.

Global application of National Comprehensive Cancer Network resource-stratified guidelines for systemic treatment of colon cancer: a population-based, customisable model for cost, demand, and procurement.

Resource-stratified guidelines (RSGs) can inform systemic treatment decisions in the face of limited resources. The objective of this study was to develop a customisable modelling tool to predict the demand, cost, and drug procurement needs of delivering National Comprehensive Cancer Network (NCCN) RSG-based systemic treatment for colon cancer. We developed decision trees for first-course systemic therapy for colon cancer based on the NCCN RSGs. Decision trees were merged with data from the Surveillance, Epidemiology, and End Results programme, the International Agency for Research on Cancer's GLOBOCAN 2020 national estimates for colon cancer incidence, country-level income data, and data on drug costs from Redbook (USA), the Pharmaceutical Benefits Scheme (Australia), and the Management Sciences for Health 2015 International Medical Products price guide to estimate global treatment needs and costs, and forecast drug procurement. Simulations and sensitivity analyses were used to explore the effect of scaling up services globally and the effect of alternative stage distributions on treatment demand and cost. We generated a customisable model, in which estimates can be tailored to local incidence, epidemiological, and costing data. First-course systemic therapy is indicated in 608 314 (53·6%) of 1 135 864 colon cancer diagnoses in 2020. Indications for first-course systemic therapy are projected to rise to 926 653 in 2040; the indications in 2020 might be as high as 826 123 (72·7%), depending on stage distribution assumptions. Adhering to NCCN RSGs, patients with colon cancer in low-income and middle income countries (LMICs) would constitute 329 098 (54·1%) of 608 314 global systemic therapy demands, but only 10% of global expenditure on systemic therapies. The total cost of NCCN RSG-based first-course systemic therapy for colon cancer in 2020 would be between about US$4·2 and about $4·6 billion, depending on stage distribution. If all patients with colon cancer in 2020 were treated according to maximal resources, global expenditure on systemic therapy for colon cancer would rise to around $8·3 billion. We have developed a customisable model that can be applied at global, national, and subnational levels to estimate systemic treatment needs, forecast drug procurement, and calculate expected drug costs on the basis of local data. This tool can be used to plan resource allocation for colon cancer globally. None.

Enhancing colon cancer care in restricted-resource settings.

Colon cancer ranks third among the most frequently diagnosed cancers worldwide and was projected to claim more than 900 000 lives in 2020, according to the International Agency for Research on Cancer's GLOBOCAN data. 1 Sung H Ferlay J Siegel RL et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021; 71: 209-249 Crossref PubMed Scopus (30514) Google Scholar The overall survival rate for colon cancer varies on the basis of clinical and pathological factors, such as staging, performance status, and geographical location. Despite the lower incidence, survival of colon cancer in low-income and middle-income countries (LMICs) is considerably reduced compared with high-income and very-high-income countries, which is probably attributable to disparities in diagnostic and treatment access. Considering expected increases in colon cancer incidence due to demographic and dietary changes, there is an urgent and unmet need to enhance cancer care in LMICs through better resource allocation and cost-effective interventions to achieve optimal value for money and reduce health inequalities. 2 Khan SZ Lengyel CG Challenges in the management of colorectal cancer in low- and middle-income countries. Cancer Treat Res Commun. 2023; (published online April 6.)https://doi.org/10.1016/j.ctarc.2023.100705 Crossref Scopus (0) Google Scholar Global application of National Comprehensive Cancer Network resource-stratified guidelines for systemic treatment of colon cancer: a population-based, customisable model for cost, demand, and procurementWe have developed a customisable model that can be applied at global, national, and subnational levels to estimate systemic treatment needs, forecast drug procurement, and calculate expected drug costs on the basis of local data. This tool can be used to plan resource allocation for colon cancer globally. Full-Text PDF

1335P Using adaptive health technology assessment (aHTA) to assess the potential cost-effectiveness of pembrolizumab and palbociclib in the Indian context

Significant survival benefit is seen with pembrolizumab monotherapy for untreated PD-L1-positive metastatic non-small-cell lung cancer and palbociclib for previously untreated, hormone receptor-positive, HER-2 negative, locally advanced, or metastatic breast cancer. However, access and affordability of these drugs remain challenging in low middle-income countries, including India. To improve the access to meaningful treatment options, India’s health insurance scheme, AB-PMJAY, has linked the oncology packages to National Cancer Grid (NCG) resource-stratified guidelines.

Development, implementation and validation of resource-stratified guidelines in low-income and middle-income countries: a scoping review protocol

IntroductionNearly every field of medicine has some form of clinical practice guidelines. However, only within the past 5–10 years has the medical community acknowledged the need for well-developed guidelines tailored...

Physicians' attitudes and perceived barriers to adherence to the national breast cancer clinical practice guidelines in Mexico: a survey study.

Adherence to clinical practice guidelines improves outcomes for patients with breast cancer. However, their implementation may not be feasible in low- and middle-income countries. This study aimed to evaluate physicians' adherence, attitudes, and barriers towards the Colima Consensus, which is the Mexican national breast cancer clinical practice guideline. A cross-sectional, 31-item survey was e-mailed to Consensus attendees and members of the Mexican Society of Oncology and Mexican Mastology Association. Descriptive statistics, univariate, and multivariate analysis were used to analyze the associations between participants' characteristics, adherence, attitudes, and barriers. Of 439 respondents, 78% percent adhered to Consensus recommendations and 94% believed it was applicable to their clinical practice. Forty percent reported using the Consensus as their sole breast cancer guideline. This was associated with being a surgical oncologist (OR 3.3, 95% CI 2.0-5.3) and practicing at a public hospital (OR 2.1, 95% CI 1.2-3.7). The most common barriers to adherence were lack of resources and logistical problems. Regarding attitudes towards the Consensus, 90% considered it a good educational tool, 89% considered it a reliable source of information, and 90% thought it improved quality of care. We showed high levels of adherence and positive attitudes towards the Colima Consensus, with a significant proportion of physicians using it as their only guideline. Lack of resources and logistical issues were the main barriers to adherence. Our results highlight the relevance of local breast cancer guidelines and suggest a need for the creation of resource-stratified guidelines.

Resource Oriented Decision Making for Treatment of Metastatic Colorectal Cancer (mCRC) in a Lower-Middle Income Country: Egyptian Foundation of Medical Sciences (EFMS) Consensus Recommendations 2020.

PurposeColorectal cancer (CRC) is the third most commonly diagnosed cancer worldwide and the second cause of cancer related mortality. Treatment options for patients with metastatic CRC (mCRC) expanded during the last two decades, with introduction of new chemotherapeutic and targeted agents. Egypt is a lower middle-income country; Egyptian health care system is fragmented with wide diversity in drug availability and reimbursement policies across different health care providing facilities. We report the results of consensus recommendations for treatment of patients with metastatic colorectal cancer developed by Egyptian Foundation of Medical Sciences (EFMS), aiming to harmonize clinical practice through structured expert consensus-based recommendations consistent with the national status. EFMS recommendations could be utilized in other countries with similar economic status.MethodsEFMS recommendations were developed using a modified Delphi process, with three rounds of voting till the final recommendations were approved. A non-systematic review of literature was conducted before generating the provisional statements. Content experts were asked to vote on some recommendations in two different resource groups (restricted resources and non-restricted resources). External review board of experts from a low income and lower-middle countries voted on the applicability of EFMS recommendations in their countries.ResultsThe current recommendations highlighted the discrepancy in health care between restricted and non-restricted resources with expected survival loss and quality of life deterioration. Access to targeted agents in first line is very limited in governmental institutions, and no access to agents approved for third line in patients who failed oxaliplatin and irinotecan containing regimens for patients treated in restricted resource settings.ConclusionManagement of mCRC in developing countries is a challenge. The currently available resource-stratified guidelines developed by international cancer societies represent a valuable decision-making tool, adaptation to national status in each country based on healthcare system status is required.

Provider Barriers and Facilitators of Breast Cancer Guideline-Concordant Therapy Delivery in Botswana: A Consolidated Framework for Implementation Research Analysis.

IntroductionSystemic treatment for breast cancer in sub‐Saharan Africa (SSA) is cost effective. However, there are limited real‐world data on the translation of breast cancer treatment guidelines into clinical practice in SSA. The study aimed to identify provider factors associated with adherence to breast cancer guideline‐concordant care at Princess Marina Hospital (PMH) in Botswana.Materials and MethodsThe Consolidated Framework for Implementation Research was used to conduct one‐on‐one semistructured interviews with breast cancer providers at PMH. Purposive sampling was used, and sample size was determined by thematic saturation. Transcribed interviews were double‐coded and analyzed in NVivo using an integrated analysis approach.ResultsForty‐one providers across eight departments were interviewed. There were variations in breast cancer guidelines used. Facilitators included a strong tension for change and a government‐funded comprehensive cancer care plan. Common provider and health system barriers were lack of available resources, staff shortages and poor skills retention, lack of relative priority compared with HIV/AIDS, suboptimal interdepartmental communication, and lack of a clearly defined national cancer control policy. Community‐level barriers included accessibility and associated transportation costs. Participants recommended the formal implementation of future guidelines that involved key stakeholders in all phases of planning and implementation, strategic government buy‐in, expansion of multidisciplinary tumor boards, leveraging nongovernmental and academic partnerships, and setting up monitoring, evaluation, and feedback processes.DiscussionThe study identified complex, multilevel factors affecting breast cancer treatment delivery in Botswana. These results and recommendations will inform strategies to overcome specific barriers in order to promote standardized breast cancer care delivery and improve survival outcomes.Implications for PracticeTo address the increasing cancer burden in low‐ and middle‐income countries, resource‐stratified guidelines have been developed by multiple international organizations to promote high‐quality guideline‐concordant care. However, these guidelines still require adaptation in order to be successfully translated into clinical practice in the countries where they are intended to be used. This study highlights a systematic approach of evaluating important contextual factors associated with the successful adaptation and implementation of resource‐stratified guidelines in sub‐Saharan Africa. In Botswana, there is a critical need for local stakeholder input to inform country‐level and facility‐level resources, cancer care accessibility, and community‐level barriers and facilitators.

Resource stratified guidelines for cancer: Are they all the same? Interguideline concordance for systemic treatment recommendations.

A number of organizations are producing resource stratified guidelines (RSGs) for cancer. Despite using similar definitions of resource levels, systemic treatment recommendations often differ between organizations. We systematically searched for RSGs focusing on solid tumors. We qualitatively compared the methods used to generate guidelines using the AGREE-II appraisal tool. We extracted systemic treatment recommendations and assessed interguideline concordance using the Gwet AC1 coefficient, stratified by resource level, treatment setting and cancer type. We identified 69 RSGs cancer covering 15 solid tumors produced by four organizations. Despite using common resource-level definitions (Basic, Core/Limited, Enhanced and Maximal), recommendations differed between organizations. Concordance for chemotherapy recommendations was poor in Basic (58.3%, Gwet 0.20), fair in Core (58.3%, Gwet 0.32) and excellent in Enhanced (92.4%, Gwet 0.92) and Maximal settings (95.4%, Gwet 0.95). Concordance rates for endocrine therapy were good in Basic (80% Gwet 0.61), and excellent in Core (90%, Gwet 0.87), Enhanced (90%, Gwet 0.89) and Maximal settings (90%, Gwet 0.89). There was moderate to excellent concordance in targeted therapy recommendations across all resource levels. Differences in recommendations appeared driven by different opinions among the chosen panel of experts regarding what is resource appropriate. Overall, we found that countries looking to base treatment and health-policy on RSGs will find conflicting information depending on which guidelines are used, particularly for chemotherapy in Basic and Core settings. Improved transparency regarding the methods used to determine the value of a therapy for a given resource level is needed.

Are NCCN Resource-Stratified Guidelines for Breast Cancer Systemic Therapy Achievable? A Population-Based Study of Global Need and Economic Impact.

PURPOSEResource-stratified guidelines (RSG) for cancer provide a hierarchy of interventions, based on resource availability. We quantify treatment need and cost if National Comprehensive Cancer Network (NCCN) RSGs for breast cancer (BC) are adopted globally.METHODSWe developed decision trees for first-course systemic therapy, merged with SEER and Global Cancer Observatory 2018 incidence data to estimate treatment need and cost if NCCN RSG are implemented globally based on country-level income. Simulations were used to quantify need and cost of globally scaling up services to Maximal.RESULTSBased on NCCN RSG, first-course chemotherapy is indicated in 0% (Basic), 87% (Core), and 86% (Enhanced) but declined to 50% (Maximal) because of incorporation of genomic profiling. First-course endocrine therapy (ET) is indicated in 80% in all settings. In 2018, treatment need was 1.4 million people for chemotherapy, 183,943 for human epidermal growth factor receptor 2 (HER2) therapies and 1.6 million for ET. The cost per person for chemotherapy or HER2 or immunotherapy increased by 17-fold from Core to Maximal ($1,278-$22,313 Australian dollars [AUD]). The cost of ET per person rose eight-fold from Basic to Maximal ($1,236-$9,809 AUD). If all patients with BC globally were treated with Maximal resources, the need for chemotherapy would decline by 28%, whereas cost of first-course treatment would rise by 1.8-fold ($21-$37 billion AUD) because of more costly therapies.CONCLUSIONNCCN RSGs for BC could result in chemotherapy overtreatment in Core and Enhanced settings. The absence of chemotherapy in Basic settings should be reconsidered, and future iterations of RSG should perform cross-tumor comparisons to ensure equitable resource distribution and maximize population-level outcomes. Our model is flexible and can be tailored to the costs, population attributes, and resource availability of any institution or country for health-services planning.

Interruption of cancer screening services due to COVID-19 pandemic: lessons from previous disasters.

To review the scientific literature seeking lessons for the COVID-19 era that could be learned from previous health services interruptions that affected the delivery of cancer screening services. A systematic search was conducted up to April 17, 2020, with no restrictions on language or dates and resulted in 385 articles. Two researchers independently assessed the list and discussed any disagreements. Once a consensus was achieved for each paper, those selected were included in the review. Eleven articles were included. Three studies were based in Japan, two in the United States, one in South Korea, one in Denmark, and the remaining four offered a global perspective on interruptions in health services due to natural or human-caused disasters. No articles covered an interruption due to a pandemic. The main themes identified in the reviewed studies were coordination, communication, resource availability and patient follow-up. Lessons learned applied to the context of COVID-19 are that coordination involving partners across the health sector is essential to optimize resources and resume services, making them more resilient while preparing for future interruptions. Communication with the general population about how COVID-19 has affected cancer screening, measures taken to mitigate it and safely re-establish screening services is recommended. Use of mobile health systems to reach patients who are not accessing services and the application of resource-stratified guidelines are important considerations. More research is needed to explore best strategies for suspending, resuming and sustaining cancer screening programs, and preparedness for future disruptions, adapted to diverse health care systems.

Resource-Stratified Guideline-Based Cancer Care Should Be a Priority: Historical Context and Examples of Success

Low- and middle-income countries (LMICs) are shouldering most of the burden of the rapidly increasing cancer incidence and mortality worldwide, and this situation is projected to worsen in coming decades. Studies estimate that more than one million deaths could be prevented annually if all patients received high-quality care, but most LMICs lack the resources and infrastructure to adopt U.S. or European clinical oncology practice guidelines. Several organizations have developed resource-stratified guidelines (RSGs) to provide graduated and/or region-specific strategies for cancer diagnosis and treatment. The birth of these efforts traces to 2002, when the World Health Organization (WHO) called for tailoring cancer treatments to the level of available resources by country; the Breast Health Global Initiative (BHGI) formalized the first stratified guidelines for breast cancer shortly thereafter. Since then, multiple organizations including ASCO and the National Comprehensive Cancer Network (NCCN) have created guidelines customized for various cancer subtypes and regions. These RSGs offer roadmaps for policy makers, clinicians, and health care administrators in LMICs to design projects in implementation science that can gradually and strategically raise the quality of cancer care in their nation or region. Although the same resource limitations that complicate cancer care in these areas also pose barriers to data gathering and research, some countries have met the challenge and are improving cancer care using RSGs as a metric for success.

The central role of provider training in implementing resource-stratified guidelines for palliative care in low-income and middle-income countries: Lessons from the Jamaica Cancer Care and Research Institute in the Caribbean and Universidad Católica in Latin America.

Individuals in low-income and middle-income countries (LMICs) account for approximately two-thirds of cancer deaths worldwide, and the vast majority of these deaths occur without access to essential palliative care (PC). Although resource-stratified guidelines are being developed that take into account the actual resources available within a given country, and several components of PC are available within health care systems, PC will never improve without a trained workforce. The design and implementation of PC provider training programs is the lynchpin for ensuring that all seriously ill patients have access to quality PC services. Building on the Breast Health Global Initiative's resource-stratified recommendations for provider education in PC, the authors report on efforts by the Jamaica Cancer Care and Research Institute in the Caribbean and the Universidad Católica in successfully developing and implementing PC training programs in the Caribbean and Latin America, respectively. Key aspects of this approach include: 1) fostering strategic academic partnerships to bring additional expertise and support to the effort; 2) careful adaptation of the curriculum to the local context and culture; 3) early identification of feasible metrics to facilitate program evaluation and future outcomes research; and 4) designing PC training programs to meet local health system needs.

The role of dissemination and implementation science in global breast cancer control programs: Frameworks, methods, and examples.

Global disparities in breast cancer outcomes are attributable to a sizable gap between evidence and practice in breast cancer control and management. Dissemination and implementation science (D&IS) seeks to understand how to promote the systematic uptake of evidence-based interventions and/or practices into real-world contexts. D&IS methods are useful for selecting strategies to implement evidence-based interventions, adapting their implementation to new settings, and evaluating the implementation process as well as its outcomes to determine success and failure, and adjust accordingly. Process models, explanatory theories, and evaluation frameworks are used in D&IS to develop implementation strategies, identify implementation outcomes, and design studies to evaluate these outcomes. In breast cancer control and management, research has been translated into evidence-based, resource-stratified guidelines by the Breast Health Global Initiative and others. D&IS should be leveraged to optimize the implementation of these guidelines, and other evidence-based interventions, into practice across the breast cancer care continuum, from optimizing public education to promoting early detection, increasing guideline-concordant clinical practice among providers, and analyzing and addressing barriers and facilitators in health care systems. Stakeholder engagement through processes such as co-creation is critical. In this article, the authors have provided a primer on the contribution of D&IS to phased implementation of global breast cancer control programs, provided 2 case examples of ongoing D&IS research projects in Tanzania, and concluded with recommendations for best practices for researchers undertaking this work.

Designing a resource-stratified, phased implementation strategy for breast health care services in India.

Breast cancer is the most common cancer among women in India. Jhpiego, a not-for-profit health organization, is providing technical assistance for developing an evidence-based model of breast health care in the states of Uttar Pradesh and Jharkhand in India. A situational assessment of breast health care services using validated tools was conducted in the 2 states. Findings of the assessment were presented to the Breast Health Technical Advisory Committee comprised of subject experts and government functionaries. The committee, guided by Breast Health Global Initiative resource-stratified guidelines, developed a conceptual framework for integration of breast health services into the existing health system. This conceptual framework was presented to the Technical Advisory Groups (TAGs) of the respective state governments. Each TAG then developed an operationally feasible, contextually appropriate implementation plan in alignment with the national guidelines for noncommunicable diseases. This implementation plan guided the rollout of the breast health care program in the Lucknow (Uttar Pradesh) and Ranchi (Jharkhand) districts. Early results from the implementation suggest that it is feasible to integrate the breast health care pathway with the ongoing National Cancer Control Program of India.

Breast cancer early detection: A phased approach to implementation.

When breast cancer is detected and treated early, the chances of survival are very high. However, women in many settings face complex barriers to early detection, including social, economic, geographic, and other interrelated factors, which can limit their access to timely, affordable, and effective breast health care services. Previously, the Breast Health Global Initiative (BHGI) developed resource-stratified guidelines for the early detection and diagnosis of breast cancer. In this consensus article from the sixth BHGI Global Summit held in October 2018, the authors describe phases of early detection program development, beginning with management strategies required for the diagnosis of clinically detectable disease based on awareness education and technical training, history and physical examination, and accurate tissue diagnosis. The core issues address include finance and governance, which pertain to successful planning, implementation, and the iterative process of program improvement and are needed for a breast cancer early detection program to succeed in any resource setting. Examples are presented of implementation, process, and clinical outcome metrics that assist in program implementation monitoring. Country case examples are presented to highlight the challenges and opportunities of implementing successful breast cancer early detection programs, and the complex interplay of barriers and facilitators to achieving early detection for breast cancer in real-world settings are considered.

Breast Imaging in Global Health: Serving the Underserved

To review the current guidelines, recommendations, and strategies for implementing breast imaging programs in low-resource areas, specifically low- and middle-income countries. Breast cancer in low- and middle-income countries is associated with high mortality, mostly related to late stage diagnosis and poor access to treatment. Efforts to improve breast cancer outcomes have focused on a strategy of downstaging disease, following resource-stratified guidelines. Launching a sustainable breast imaging program in a low-resource area involves a thorough assessment that includes existing infrastructure, staffing and equipment resources, and access to downstream care. A number of programs have shown promise in improving early detection by utilizing a multifaceted approach and incorporating various healthcare technologies and innovation.

Development of a theory-driven implementation strategy for cancer management guidelines in sub-Saharan Africa

BackgroundDespite recent international efforts to develop resource-stratified clinical practice guidelines for cancer, there has been little research to evaluate the best strategies for dissemination and implementation in low- and middle-income countries (LMICs). Guideline publication alone is insufficient. Extensive research has shown that structured, multifaceted implementation strategies that target barriers to guideline use are most likely to improve adherence; however, most of this research has been conducted in high-income countries. There is a pressing need to develop and evaluate guideline implementation strategies for cancer management in LMICs in order to address stark disparities in cancer outcomes.MethodsIn preparation for the launch of Tanzania’s first National Cancer Treatment Guidelines, we developed a theory-driven implementation strategy for guideline-based practice at Ocean Road Cancer Institute (ORCI). Here, we use the Intervention Mapping framework to provide a detailed stepwise description of our process. First, we conducted a needs assessment to identify barriers and facilitators to guideline-based practice at ORCI. Second, we defined both proximal and performance objectives for our implementation strategy. Third, we used the Capability, Opportunity, Motivation and Behavior/Behavior Change Wheel (COM-B/BCW) framework to categorize the barriers and facilitators, choose behavior change techniques most likely to overcome targeted barriers and leverage facilitators, and select a feasible mode of delivery for each technique. Fourth, we organized these modes of delivery into a phased implementation strategy. Fifth, we operationalized each component of the strategy. Sixth, we identified the indicators of the process, outcome, and impact of our intervention and developed an evaluation plan to measure them using a mixed methods approach.DiscussionWe developed a robust, multifaceted guideline implementation strategy derived from a prominent behavior change theory for use in Tanzania. The barriers and strategies we generated are consistent with those well established in the literature, enhancing the validity and generalizability of our process and results. Through our rigorous evaluation plan and systematic account of modifications and adaptations, we will characterize the transferability of “proven” guideline implementation strategies to LMICs. We hope that by describing our process in detail, others may endeavor to replicate it, meeting a widespread need for dedicated efforts to implement cancer guidelines in LMICs.

Challenges and Unmet Oncofertility Needs in Hematopoietic Stem Transplant Recipients in a Middle-Income Nation

Lack of fertility assessment (FA) and counsel (FC) has a negative impact on quality of life in cancer survivors. Cryopreservation (CP) offers a possibility of future progeny in both males and females. Hematopoietic stem cell transplant (HSCT) recipients are a high-risk group, whose increased risk of relapse limits time off of therapy for CP. Our aim was to evaluate trends in pre and post-HSCT gonadal dysfunction (GD) in HSCT recipients in a referral center in Latin America. This is a retrospective single-center study that included patients who underwent HSCT at our institution from June 2000 to May 2018, whose baseline diagnosis was established at Inclusion criteria were met by 213 patients. Median age at diagnosis was 26 years and 64.8% were male. 70.4% were of low socioeconomic (SE) status (monthly income Median age at HSCT was 29 years. HSCT was autologous in 54.9%. Median time from diagnosis to HSCT was 15 months and was 3 months from last therapy to HSCT. Conditioning regimen was myeloablative (MA) in 87.1% (Figure 1). Full pre-HSCT biochemical FA was available in 71.8% of patients (n=153) being consistent with GD in 22.9% (n=35). Female gender was associated with pre-HSCT GD (p At 6 months post-HSCT 193 patients were evaluable. Only 47.7% (n=92) had full FA. GD was present in 47.8% (n=44) and was related to female gender (p=0.03). Within females increased median concentration of FSH (p Despite the young age of our cohort few patients received FC. CP was almost null due to SE constrains, accessibility, and limited therapy-free time. Only 1 of every 4 patients had biochemical evidence suggestive of GD pre-HSCT. Greater care must be taken to allocate intervals for CP while weighing risk of relapse. Factors related to GD were female gender, MA regimens in females, and GCT in males; possibly evidencing the role of the blood-testis barrier in decreasing intragonadal drug concentrations. The reduced proportion of post-HSCT FA evidences lack of awareness among clinicians. Our results show the great need of multidisciplinary approaches in HSCT recipients and resource-stratified guidelines to select those with the greatest potential to benefit from a fertility perspective.