Adults' Experiences with Type 2 Diabetes in Rural Guatemala: A Qualitative Study.

BACKGROUND: Given that the diabetes burden is rising rapidly in low- and middle-income countries, it is critical to understand perspectives of people living with diabetes in these settings. This qualitative study examines perceptions of causality and treatment among adults with type 2 diabetes in rural Indigenous communities of Guatemala. METHODS: We conducted semi-structured interviews with 29 people living with type 2 diabetes from a population survey in two majority Indigenous Guatemalan towns. Data were coded inductively and themes were elucidated by consensus. RESULTS: Participants emphasized strong emotional experiences and stress as perceived causes of diabetes, as well as diet and heritability. All participants took biopharmaceutical treatments, but many also endorsed diet, exercise, herbal remedies, and naturopathic products as important remedies. CONCLUSION: Perspectives from people living with diabetes in two rural Indigenous towns in Guatemala differ from the biomedical model of disease and have implications for clinical practice and program development.

Qualitative study of pathways to care among adults with diabetes in rural Guatemala.

OBJECTIVE: The burden of diabetes mellitus is increasing in low-income and middle-income countries (LMICs). Few studies have explored pathways to care among individuals with diabetes in LMICs. This study evaluates care trajectories among adults with diabetes in rural Guatemala. DESIGN: A qualitative investigation was conducted as part of a population-based study assessing incidence and risk factors for chronic kidney disease in two rural sites in Guatemala. A random sample of 807 individuals had haemoglobin A1c (HbA1c) screening for diabetes in both sites. Based on results from the first 6 months of the population study, semistructured interviews were performed with 29 adults found to have an HbA1c≥6.5% and who reported a previous diagnosis of diabetes. Interviews explored pathways to and experiences of diabetes care. Detailed interview notes were coded using NVivo and used to construct diagrams depicting each participant's pathway to care and use of distinct healthcare sectors. RESULTS: Participants experienced fragmented care across multiple health sectors (97%), including government, private and non-governmental sectors. The majority of participants sought care with multiple providers for diabetes (90%), at times simultaneously and at times sequentially, and did not have longitudinal continuity of care with a single provider. Many participants experienced financial burden from out-of-pocket costs associated with diabetes care (66%) despite availability of free government sector care. Participants perceived government diabetes care as low-quality due to resource limitations and poor communication with providers, leading some to seek care in other health sectors. CONCLUSIONS: This study highlights the fragmented, discontinuous nature of diabetes care in Guatemala across public, private and non-governmental health sectors. Strategies to improve diabetes care access in Guatemala and other LMICs should be multisectorial and occur through strengthened government primary care and innovative private and non-governmental organisation care models.

Perceptions of chronic kidney disease among at-risk adults in rural Guatemala.

This qualitative study explores perceptions of chronic kidney disease (CKD) among adults with abnormal estimated glomerular filtration rate (eGFR) in Guatemala, where the burden of CKD is rising. Qualitative semi-structured interviews were conducted with 39 individuals screened for CKD and found to have abnormal eGFR (defined as <90 mL/min/1.73 m2, per Kidney Disease Improving Global Outcomes [KDIGO] guidelines). Interviews occurred in participants' homes in Spanish or Kaqchikel Mayan. Interview notes were coded for dominant themes through an inductive approach. Interviewees had limited awareness of diabetes and hypertension as CKD risk factors, but appreciated the progressive nature of the disease. While most reported willingness to pursue renal replacement therapies, if necessary, they anticipated economic and geographic barriers. Public health interventions should focus on the association between diabetes, hypertension, and CKD. Improvement of primary care and screening infrastructure is imperative in CKD prevention in low- and middle-income countries (LMICs).

Challenges in the provision of kidney care at the largest public nephrology center in Guatemala: a qualitative study with health professionals.

BACKGROUND: Chronic kidney disease (CKD) is increasing worldwide, and the majority of the CKD burden is in low- and middle-income countries (LMICs). However, there is wide variability in global access to kidney care therapies such as dialysis and kidney transplantation. The challenges health professionals experience while providing kidney care in LMICs have not been well described. The goal of this study is to elicit health professionals' perceptions of providing kidney care in a resource-constrained environment, strategies for dealing with resource limitations, and suggestions for improving kidney care in Guatemala. METHODS: Semi-structured interviews were performed with 21 health professionals recruited through convenience sampling at the largest public nephrology center in Guatemala. Health professionals included administrators, physicians, nurses, technicians, nutritionists, psychologists, laboratory personnel, and social workers. Interviews were recorded and transcribed in Spanish. Qualitative data from interviews were analyzed in NVivo using an inductive approach, allowing dominant themes to emerge from interview transcriptions. RESULTS: Health professionals most frequently described challenges in providing high-quality care due to resource limitations. Reducing the frequency of hemodialysis, encouraging patients to opt for peritoneal dialysis rather than hemodialysis, and allocating resources based on clinical acuity were common strategies for reconciling high demand and limited resources. Providers experienced significant emotional challenges related to high patient volume and difficult decisions on resource allocation, leading to burnout and moral distress. To improve care, respondents suggested increased budgets for equipment and personnel, investments in preventative services, and decentralization of services. CONCLUSIONS: Health professionals at the largest public nephrology center in Guatemala described multiple strategies to meet the rising demand for renal replacement therapy. Due to systems-level limitations, health professionals faced difficult choices on the stewardship of resources that are linked to sentiments of burnout and moral distress. This study offers important lessons in Guatemala and other countries seeking to build capacity to scale-up kidney care.

Response Rate as a Regulatory End Point in Single-Arm Studies of Advanced Solid Tumors.

IMPORTANCE: Objective response rate (ORR) is an increasingly important end point for accelerated development of highly active anticancer therapies, yet its relationship to regulatory approval is not well characterized. OBJECTIVE: To identify circumstances in which a high ORR is associated with regulatory approval, and therefore might be an appropriate end point for definitive single-arm studies of anticancer therapies. DATA SOURCE: A database of all oncology clinical trials registered at clinicaltrials.gov between October 1, 2007, and September 30, 2010. STUDY SELECTION: Trials of palliative systemic therapies for 4 measurable solid tumor types, limited to those with trial arms of at least 20 patients reporting ORR per Response Evaluation Criteria in Solid Tumors (RECIST). DATA EXTRACTION AND SYNTHESIS: A systematic search was used to identify the reported ORR for each eligible treatment arm that had been presented publicly. MAIN OUTCOMES AND MEASURES: For each treatment regimen, defined as a single-agent or unique combination of agents for 1 cancer type, the mean ORR and the maximum ORR statistically exceeded were calculated, and their association with regulatory approval was studied. A regimen was considered approved for a specific cancer type if it had received regulatory approval in any country for treatment of advanced cancer of that type. RESULTS: From 1800 trials, 874 eligible trial arms in 578 eligible trials were identified; 542 arms had ORR data available for 294 regimens. Maximum ORR and mean ORR were significantly associated with regulatory approval (τ = 0.27, P < .001; τ = 0.12, P = .01); this relationship was stronger for single-agent therapies (τ = 0.49; τ = 0.41) than for combination regimens (τ = 0.28; τ = 0.17). Evaluation of ORR thresholds between 20% and 60% as potential trial end points demonstrated that ORR statistically exceeding 30% with a single agent had 98% specificity and 89% positive predictive value for identifying regimens achieving regulatory approval. CONCLUSIONS AND RELEVANCE: For single-agent regimens, high ORR was associated with regulatory approval; this relationship was less strong for combination regimens. Our data suggest that high ORR (eg, statistically exceeding an ORR of 30%) is an appropriate end point for single-arm trials aiming to demonstrate breakthrough activity of a single-agent anticancer therapy.