Overall survival (OS) in metastatic melanoma since the introduction of immunotherapy: A National Cancer Database analysis.

e19333 Background: Metastatic melanoma historically had a very poor prognosis and survival until the utilization of immunotherapy. Ipilimumab, the first immune checkpoint (ICP) inhibitor was approved in March 2011, followed soon after by the approval of PD-1 and PD-L1 inhibitors. We aim to conduct a real-world analysis of survival outcomes before and after 2011 in metastatic melanoma and its subtypes. We will also explore the impact of race on the clinical presentation and outcomes of melanoma. Methods: Adults with metastatic melanoma were identified from the NCDB (2004-2015). Kaplan Meier method was used to estimate survival and Cox proportional hazards model was used to determine hazard ratio (HR) for death after adjusting for age, race, sex, comorbidity index, melanoma type, education, income, insurance, facility type and geographical location. Odds of having metastatic disease at diagnosis were estimated using multivariate log regression analysis. Results: Of the 20,691 metastatic melanoma cases, 19,492 (94.2%) were cutaneous, 326 (1.6%) were ocular and 873 (4.2%) were mucosal. The effect of immunotherapy use on survival in metastatic melanoma was assessed by comparing years 2011-2015 versus 2004-2010. After the introduction of immunotherapy in 2011, the adjusted survival for metastatic melanoma had improved in Caucasians (HR 0.80, p < 0.001, CI 0.77-0.83) but not in African Americans (HR 0.80, p value = 0.08, CI 0.62-1.03). Although, AA constituted a minority in each melanoma group (1.7% cases of cutaneous, 1.5% of ocular and 8.1% of mucosal melanoma), their odds of having metastatic disease at onset was higher in both cutaneous (OR 2.60, p < 0.001 CI 2.28-2.95) and mucosal melanoma (OR 1.85, p < 0.001 CI 1.39-2.47) compared to Caucasians. Conclusions: Real-world data suggested a 20% improvement in survival of metastatic melanoma since the introduction of ICP inhibitors except in the subgroups of ocular melanoma and African Americans. The disproportionately high odds of metastatic disease at presentation in African American patients with melanoma suggests the need for improvement in care delivery, specifically in terms of early detection. [Table: see text]

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NCDB Analysis of Melanoma 2004–2015: Epidemiology and Outcomes by Subtype, Sociodemographic Factors Impacting Clinical Presentation, and Real-World Survival Benefit of Immunotherapy Approval

Cancers ◽

10.3390/cancers13061455 ◽

2021 ◽

Vol 13 (6) ◽

pp. 1455

Author(s):

Sunny R. K. Singh ◽

Sindhu J. Malapati ◽

Rohit Kumar ◽

Christopher Willner ◽

Ding Wang

Keyword(s):

Metastatic Melanoma ◽

Metastatic Disease ◽

Real World ◽

Care Delivery ◽

Sociodemographic Factors ◽

P Value ◽

Real World Data ◽

Factors Associated ◽

Improvement In Survival ◽

The Impact

Background: The incidence of invasive melanoma is rising, and approval for the first immune checkpoint inhibitor (ICI) to treat metastatic melanoma occurred in 2011. We aim to describe the epidemiology and outcomes in recent years, sociodemographic factors associated with the presence of metastasis at diagnosis, and the real‐world impact of ICI approval on survival based on melanoma subtype and race. Methods: This is a retrospective analysis of the National Cancer Database (NCDB) from the years 2004–2015. The primary outcome was the overall survival of metastatic melanoma by subtype. Secondary outcomes included sociodemographic factors associated with the presence of metastasis at diagnosis and the impact of treatment facility type and ICI approval on the survival of metastatic melanoma. Results: Of the 419,773 invasive melanoma cases, 93.80% were cutaneous, and 4.92% were metastatic at presentation. The odds of presenting with metastatic disease were higher in African Americans (AA) compared to Caucasians (OR 2.37; 95% CI 2.11–2.66, p < 0.001). Treatment of metastatic melanoma at an academic/research facility was associated with lower mortality versus community cancer programs (OR 0.75, 95 % CI 0.69–0.81, p-value<0.001). Improvement in survival of metastatic melanoma was noted for Caucasians after the introduction of ICI (adjusted HR 0.80, 95% CI 0.78–0.83, p < 0.001); however, this was not statistically significant for AA (adjusted HR 0.80, 95% CI 0.62–1.02, p‐value = 0.073) or ocular cases (HR 1.03, 95% CI 0.81–1.31, p‐value 0.797). Conclusion: Real‐world data suggest a 20% improvement in survival of metastatic melanoma since the introduction of ICI. The disproportionately high odds of metastatic disease at presentation in AA patients with melanoma suggest the need for a better understanding of the disease and improvement in care delivery.

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Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.110 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 110-110 ◽

Cited By ~ 5

Author(s):

Sean Khozin ◽

Mark S. Walker ◽

Monika Jun ◽

Li Chen ◽

Edward Stepanski ◽

...

Keyword(s):

Autoimmune Disease ◽

Real World ◽

Proportional Hazards ◽

Proportional Hazards Model ◽

Checkpoint Inhibitors ◽

Progression Free Survival ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Rank Test ◽

The Impact

110 Background: Anecdotal and early evidence suggest ICIs are being used in patients with advanced malignancies and history of AD, despite such patients being typically excluded from traditional clinical trials. We compared the outcomes of patients with or without AD, all of whom had ICI treatment for aNSCLC. Methods: We conducted a retrospective, observational cohort study using de-identified, curated data in ASCO’s CancerLinQ. Patients with Stage III or IV NSCLC who received ≥1 dose of an ICI and had ≥2 visits from Jan 2011 to Nov 2018 were included. AD status prior to ICI treatment was identified using ICD-9/ICD-10 codes or AD medications (including steroids). Symphony claims data were linked via tokenization to build cohorts. Time to treatment discontinuation (TTD), time to next treatment (TTNT), real-world progression-free survival (rwPFS) and overall survival (OS) were compared across the two cohorts using the log-rank test. Cox Proportional Hazards Model was used to adjust for covariates. Adverse events (AEs) were compared using Chi-Square and Fisher’s Exact Test. Active AD was defined as evidence of autoimmune disease in the year prior to starting ICIs. Results: Among 2425 patients with aNSCLC treated with ICIs, AD was present in 22% (N=538). Median OS in all patients was 12.4 months (95% CI 11.3-13.5). TTD, TTNT, rwPFS and OS did not differ between the two cohorts (Table). There was no association between AD status and outcomes. There was no increased incidence of AEs in the AD group; however a sub-analysis among patients with active AD showed higher rates of select AEs including endocrine, GI and blood disorders. Conclusions: This analysis demonstrates that patients with evidence of AD prior to receiving ICI have similar outcomes compared to patients with no evidence of AD. Further research is needed to better understand the impact of active AD on the risk of AEs and patient outcomes. [Table: see text]

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Age at Exposure to Parental Suicide and the Subsequent Risk of Suicide in Young People

Crisis ◽

10.1027/0227-5910/a000468 ◽

2018 ◽

Vol 39 (1) ◽

pp. 27-36 ◽

Cited By ~ 5

Author(s):

Kuan-Ying Lee ◽

Chung-Yi Li ◽

Kun-Chia Chang ◽

Tsung-Hsueh Lu ◽

Ying-Yeh Chen

Keyword(s):

Young People ◽

Proportional Hazards ◽

Proportional Hazards Model ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Birth Registry ◽

Data Set ◽

Parental Suicide ◽

The Impact ◽

Age At Exposure

Abstract. Background: We investigated the age at exposure to parental suicide and the risk of subsequent suicide completion in young people. The impact of parental and offspring sex was also examined. Method: Using a cohort study design, we linked Taiwan's Birth Registry (1978–1997) with Taiwan's Death Registry (1985–2009) and identified 40,249 children who had experienced maternal suicide (n = 14,431), paternal suicide (n = 26,887), or the suicide of both parents (n = 281). Each exposed child was matched to 10 children of the same sex and birth year whose parents were still alive. This yielded a total of 398,081 children for our non-exposed cohort. A Cox proportional hazards model was used to compare the suicide risk of the exposed and non-exposed groups. Results: Compared with the non-exposed group, offspring who were exposed to parental suicide were 3.91 times (95% confidence interval [CI] = 3.10–4.92 more likely to die by suicide after adjusting for baseline characteristics. The risk of suicide seemed to be lower in older male offspring (HR = 3.94, 95% CI = 2.57–6.06), but higher in older female offspring (HR = 5.30, 95% CI = 3.05–9.22). Stratified analyses based on parental sex revealed similar patterns as the combined analysis. Limitations: As only register-based data were used, we were not able to explore the impact of variables not contained in the data set, such as the role of mental illness. Conclusion: Our findings suggest a prominent elevation in the risk of suicide among offspring who lost their parents to suicide. The risk elevation differed according to the sex of the afflicted offspring as well as to their age at exposure.

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Does Vancomycin Resistance Increase Mortality? Clinical Outcomes and Predictive Factors for Mortality in Patients with Enterococcus faecium Infections

Antibiotics ◽

10.3390/antibiotics10020105 ◽

2021 ◽

Vol 10 (2) ◽

pp. 105

Author(s):

Jatapat Hemapanpairoa ◽

Dhitiwat Changpradub ◽

Sudaluck Thunyaharn ◽

Wichai Santimaleeworagun

Keyword(s):

Risk Factors ◽

Clinical Outcomes ◽

Proportional Hazards Model ◽

Significant Risk ◽

Vancomycin Resistance ◽

Cox Proportional Hazards Model ◽

Factors Associated ◽

Joint Infections ◽

Bone And Joint Infections ◽

The Impact

The prevalence of enterococcal infection, especially E. faecium, is increasing, and the issue of the impact of vancomycin resistance on clinical outcomes is controversial. This study aimed to investigate the clinical outcomes of infection caused by E. faecium and determine the risk factors associated with mortality. This retrospective study was performed at the Phramongkutklao Hospital during the period from 2014 to 2018. One hundred and forty-five patients with E. faecium infections were enrolled. The 30-day and 90-day mortality rates of patients infected with vancomycin resistant (VR)-E. faecium vs. vancomycin susceptible (VS)-E. faecium were 57.7% vs. 38.7% and 69.2% vs. 47.1%, respectively. The median length of hospitalization was significantly longer in patients with VR-E. faecium infection. In logistic regression analysis, VR-E. faecium, Sequential Organ Failure Assessment (SOFA) scores, and bone and joint infections were significant risk factors associated with both 30-day and 90-day mortality. Moreover, Cox proportional hazards model showed that VR-E. faecium infection (HR 1.91; 95%CI 1.09–3.37), SOFA scores of 6–9 points (HR 2.69; 95%CI 1.15–6.29), SOFA scores ≥ 10 points (HR 3.71; 95%CI 1.70–8.13), and bone and joint infections (HR 0.08; 95%CI 0.01–0.62) were significant risk factors for mortality. In conclusion, the present study confirmed the impact of VR-E. faecium infection on mortality and hospitalization duration. Thus, the appropriate antibiotic regimen for VR-E. faecium infection, especially for severely ill patients, is an effective strategy for improving treatment outcomes.

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Abstract 14873: Is There Difference in Clinical Outcomes Following Percutaneous Coronary Intervention (PCI) for Acute Coronary Syndrome (ACS) between Hospitals With and Without Onsite Cardiac Surgery Backup?

Circulation ◽

10.1161/circ.130.suppl_2.14873 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Tomonori Akasaka ◽

Seiji Hokimoto ◽

Noriaki Tabata ◽

Kenji Sakamoto ◽

Kenichi Tsujita ◽

...

Keyword(s):

Cardiac Surgery ◽

Clinical Outcomes ◽

Primary Endpoint ◽

Proportional Hazards Model ◽

Cox Proportional Hazards Model ◽

Bleeding Complications ◽

Hospital Death ◽

Coronary Syndrome ◽

Significant Difference ◽

The Impact

Background: Based on 2011 ACCF/AHA/SCAI PCI guideline, it is recommended that PCI should be performed at hospital with onsite cardiac surgery. But, recent data suggests that there is no significant difference in clinical outcomes following primary or elective PCI between hospitals with and without onsite cardiac surgery. The proportion of PCI centers without onsite cardiac surgery comprises approximately more than half of all PCI centers in Japan. We examined the impact of with or without onsite cardiac surgery on clinical outcomes following PCI to ACS. Methods: From Aug 2008 to March 2011, subjects (n=2288) were enrolled from the Kumamoto Intervention Conference Study (KICS), which is a multicenter registry, and enrolling consecutive patients undergoing PCI in 15 centers in Japan. Patients were assigned to two groups treated in hospitals with (n=1954) or without (n=334) onsite cardiac surgery. Clinical events were followed up for 12 months. Primary endpoint was in-hospital death, cardiovascular death, myocardial infarction, and stroke. And we monitored other events those were non-cardiovascular deaths, bleeding complications, revascularizations, and emergent CABG. Results: There was no overall significant difference in primary endpoint between hospitals with and without onsite cardiac surgery (9.6%vs9.5%; P=0.737). There was also no significant difference when events in primary endpoint were considered separately. In other events, only revascularization was more frequently seen in hospitals with onsite cardiac surgery (22.1%vs12.9%; P<0.001). Kaplan-Meier analysis for primary endpoint showed that there was no significant difference between two groups (Log Rank P=0.943). By cox proportional hazards model analysis for primary endpoint, without onsite cardiac surgery was not a predictive factor for primary endpoint (HR 0.969, 95%CI 0.704-1.333; P=0.845). We performed propensity score matching analysis to correct for the disparate patient numbers between two groups, and there was also no significant difference for primary endpoint (6.9% vs 8.0%; P=0.544). Conclusions: There is no significant difference in clinical outcomes following PCI for ACS between hospitals with and without onsite cardiac surgery backup in Japan.

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Randomized Open-Labeled Academic Trial Comparing Standard AZA Therapy with Combination of G-CSF with AZA in High Risk MDS Patients - Interim Analysis

Blood ◽

10.1182/blood-2019-124274 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 1729-1729

Author(s):

Anna Jonasova ◽

Lubomir Minarik ◽

Vojtech Kulvait ◽

Michal Pesta ◽

Adel Schaffartzikova ◽

...

Keyword(s):

Flow Cytometry ◽

Mixed Model ◽

Proportional Hazards Model ◽

Patient Survival ◽

Conflicts Of Interest ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

P Value ◽

Pre Treatment ◽

Time Varying Covariates

Introduction: Myelodysplastic syndrome (MDS) is characterized by differentiation blockade, cytopenias with commontransfusion dependency and immune defects. Upon progression the myeloblasts accumulate and the patients become vulnerable to severe infection complications. Based on the Prague Charles University General Hospital registry (N=164, median age 73), the AZA therapy in higher-risk MDS patients results in median OS 13.8 Mo with ORR 48.5%. We also noted from our retrospective data that AZA-treated patients with higher G-CSF consumption had significantly reduced occurrence of Grade 4 neutropenias and longer OS (19 vs 16 Mo, p value 0.039). Rationale: To improve poor clinical outcomes we initiated a randomized open labeled academic trial that compares standard AZA therapy (A) with novel AZA-based therapy combination involving use of G-CSF added prior AZA (GA). Both AZA and also decitabine were preclinically shown to induce myeloid differentiation upon G-CSF preincubation. G-CSF binds its receptor in granulocytic precursors and neutrophils to stimulate their survival, proliferation, and differentiation via myeloid master regulator transcription factor and leukemia-suppressor PU.1. We also have previously shown that AZA increases PU.1. expression. Study design & Methods: GA/MDS-2013 (EudraCT No 2013-001639-38). Expected for enrollment are 134 patients, currently enrolled 53 patients (GA arm N=29, A arm N=24) with median age 74 years, M:F ratio 32:21 (GA 16:16, A 13:8),median IPSS-R 6, median follow up 11.2 Mo, median cycles of therapy 6. Diagnosis included:MDS (EB1, EB 2) with IPSS int-2/high (75%), MDS/AML<30% MB (22.5%), and CMML II (2.5%). Transplant candidates were excluded. Randomization is 2:1 for GA vs A arm. Primary endpoints: OS, PFS, time to AML transformation, ORR, infections & QoL. Secondary endpoints: biomarkers. Therapy schedule: 75mg/m2 of AZA 5-2-2, in GA: G-CSF s.c. injected 48 hrs before dose 1 and dose 6. G-CSF is measured in patient sera (prior therapy), myeloid surface markers are determined by flow cytometry (day -2, day 1, and day 9 of cycle 1). Genomic libraries from whole bone marrow are prepared by NEBNext Direct Kit involving 33 gene panel, sequencing runs are performed on Illumina platform. Statistics involved longitudinal multivariate data analysis including the joint models for the OS and response. Results: The presented data include 2.5 years since the beginning of the trial. Median survival for GA arm was 11 vs 6 Mo in the A arm. ORR (CR, CRm, PR, HI) was 56% in GA arm vs 33% in the A arm. Transformation to AML for both arms was comparable. The stratified longitudinal Cox proportional hazards model containing time-varying covariates together with the ordinal multilevel logistic mixed model were utilized. From this joint fitted model, a negative coefficient for the G-AZA treatment (significant p-value 0.0442) can be noticed in the case of the Cox Proportional Hazard part of the model. This means that G-AZA treatment improves patient survival. The estimated odds for the GA arm that responded to the therapy with remission rather than progression is 12.4x higher than for the A arm, controlling for the remaining patients' characteristics (p-value 0.0016).Both the GA and A arms are comparably tolerated. Data on serious infections and neutropenia gr4 were not yet available. The levels of G-CSF in sera prior the study in both arms (GA vs A) were comparable. Flow cytometry revealed G-CSF mediated upregulation of FCgRI (CD64) in the GA but not in the A arm. Multivariate analysis indicates the following: mutated genes: DNMT3A (p-value 0.0157), EZH2 (p-value 0.0091), TP53 (borderline p-value 0.0510), & CSF3R (p-value 0.0057) shorten the overall survival. The significant negative effects on response was noted for mutated EZH2 (p-value 0.0208) and CSF3R (p-value 0.0424) genes. Conclusions: The current results supported by different methods and statistics indicates a beneficial effect of G-CSF pre-treatment to standard AZA therapy in higher risk MDS patients. G-CSF pre-treatment to AZA increases OS and ORR. In addition, we identified biomarkers that are negatively associated with patient survival and response including EZH2, DNMT3A, TP53, & CSF3R. Grant Support: Ministry of Health, #16-27790A. Institutional resources: Progres Q49 & Q26, UNCE/MED/016, LQ1604, SVV 260374/2017, RVO-64165. Disclosures No relevant conflicts of interest to declare.

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A Cross-Sectional Survey Exploring the Impact of the COVID-19 Pandemic on the Cancer Care of Adolescents and Young Adults

Current Oncology ◽

10.3390/curroncol28040278 ◽

2021 ◽

Vol 28 (4) ◽

pp. 3201-3213

Author(s):

Kaitlyn Howden ◽

Camille Glidden ◽

Razvan G. Romanescu ◽

Andrew Hatala ◽

Ian Scott ◽

...

Keyword(s):

Young Adults ◽

Cancer Treatment ◽

Cancer Care ◽

Negative Impact ◽

Positive Impact ◽

Care Delivery ◽

Adolescents And Young Adults ◽

P Value ◽

Cross Sectional Survey ◽

The Impact

We aimed to describe the negative and positive impacts of changes in cancer care delivery due to COVID-19 pandemic for adolescents and young adults (AYAs) in Canada, as well as the correlates of negative impact and their perspectives on optimization of cancer care. We conducted an online, self-administered survey of AYAs with cancer living in Canada between January and February 2021. Multiple logistic regression was used to identify factors associated with a negative impact on cancer care. Of the 805 participants, 173 (21.5%) experienced a negative impact on their cancer care including delays in diagnostic tests (11.9%), cancer treatment (11.4%), and appointments (11.1%). A prior diagnosis of mental or chronic physical health condition, an annual income of <20,000 CAD, ongoing cancer treatment, and province of residence were independently associated with a negative cancer care impact (p-value < 0.05). The majority (n = 767, 95.2%) stated a positive impact of the changes to cancer care delivery, including the implementation of virtual healthcare visits (n = 601, 74.6%). Pandemic-related changes in cancer care delivery have unfavorably and favorably influenced AYAs with cancer. Interventions to support AYAs who are more vulnerable to the adverse effects of the pandemic, and the thoughtful integration of virtual care into cancer care delivery models is essential.

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Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

Cancers ◽

10.3390/cancers13215550 ◽

2021 ◽

Vol 13 (21) ◽

pp. 5550

Author(s):

Morten Fink ◽

Anders Schwartz Vittrup ◽

Lars Bastholt ◽

Inge Marie Svane ◽

Marco Donia ◽

...

Keyword(s):

Adverse Events ◽

Metastatic Melanoma ◽

Real World ◽

Negative Impact ◽

Cox Proportional Hazards Model ◽

Induction Phase ◽

Discontinue Treatment ◽

Real World Data ◽

World Data ◽

Significant Difference

Immune-related adverse events (irAEs) are very prevalent when treating patients with ipilimumab and nivolumab in combination, and 30–40% of patients discontinue the treatment for this reason. It is of high clinical relevance to investigate the consequences of discontinuing the treatment early since combination therapy with ipilimumab and nivolumab is the first line of treatment for many patients with metastatic melanoma. In this follow-up study, with real-world data from the nationwide DAMMED database, we investigated whether there was a difference in progression-free survival (PFS) and overall survival (OS) for patients who discontinued or did not discontinue treatment within the first four doses of treatment due to irAEs. In total, 448 patients were treated with ipilimumab and nivolumab. Of these, 133 patients discontinued due to irAEs in the induction phase. Using the Cox proportional hazards model, there was no significant difference in PFS when comparing the group that discontinued with the group that did not discontinue. The group that discontinued had a significantly longer OS than the group that received the full length of treatment. Therefore, we conclude that there is no significant negative impact on efficacy for patients who discontinue due to irAEs in the induction phase of combination immunotherapy for metastatic melanoma.

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A novel nomogram to predict the overall survival in esthesinoeroblastoma

10.21203/rs.3.rs-22163/v2 ◽

2020 ◽

Author(s):

Lijie Jiang ◽

Tengjiao Lin ◽

Yu Zhang ◽

Wenxiang Gao ◽

Jie Deng ◽

...

Keyword(s):

Overall Survival ◽

Proportional Hazards ◽

Proportional Hazards Model ◽

Validation Cohort ◽

Risk Groups ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Cancer Center ◽

P Value ◽

Training Cohort

Abstract Background Increasing evidence indicates that the pathology and the modified Kadish system have some influence on the prognosis of esthesioneuroblastoma (ENB). However, an accurate system to combine pathology with a modified Kadish system has not been established. Methods This study aimed to set up and evaluate a model to predict overall survival (OS) accurately in ENB, including clinical characteristics, treatment and pathological variables. We screened the information of patients with ENB between January 1, 1976, and December 30, 2016 from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program as a training cohort. The validation cohort consisted of patients with ENB at Sun Yat-sen University Cancer Center and The First Affiliated Hospital of Sun Yat-sen University in the same period, and 87 patients were identified. The Pearson’s chi-squared test was used to assess significance of clinicopathological and demographic characteristics. We used the Cox proportional hazards model to examine univariate and multivariate analyses. The model coefficients were used to calculate the Hazard ratios (HR) with 95% confidence intervals (CI). Prognostic factors with a p- value < 0.05 in multivariate analysis were included in the nomogram. The concordance index (c-index) and calibration curve were used to evaluate the predictive power of the nomogram. Results The c-index of training cohort and validation cohort are 0.737 (95% CI, 0.709 to 0.765) and 0.791 (95% CI, 0.767 to 0.815) respectively. The calibration curves revealed a good agreement between the nomogram prediction and actual observation regarding the probability of 3-year and 5-year survival. We used a nomogram to calculate the 3-year and 5-year growth probability and stratified patients into three risk groups. Conclusions The nomogram provided the risk group information and identified mortality risk and can serve as a reference for designing a reasonable follow-up plan.

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Evaluation of a novel approach to community health care delivery in Ifanadiana District, Madagascar

10.1101/2020.12.11.20232611 ◽

2020 ◽

Author(s):

Bénédicte Razafinjato ◽

Luc Rakotonirina ◽

Jafeta Benony Andriantahina ◽

Laura F. Cordier ◽

Randrianambinina Andriamihaja ◽

...

Keyword(s):

Health Care ◽

Quality Of Care ◽

Community Health ◽

Access To Health Care ◽

Care Delivery ◽

Local Level ◽

Scale Up ◽

P Value ◽

The Impact

AbstractDespite the widespread global adoption of community health (CH) systems, there are evidence gaps in how to best deliver community-based care aligned with global best practice in remote settings where access to health care is limited and community health workers (CHWs) may be the only available providers. PIVOT partnered with the Ministry of Public Health to pilot a new two-pronged approach for care delivery in rural Madagascar: one CHW provided care at a stationary CH site while 2-5 additional CHWs provided care via proactive household visits. The pilot included professionalization of the CHW workforce (i.e. recruitment, training, financial incentive) and twice monthly supervision of CHWs. We evaluated the impact of the CH pilot on utilization and quality of integrated community case management (iCCM) in the first six months of implementation (October 2019-March 2020).We compared utilization and proxy measures of quality of care (defined as adherence to the iCCM protocol for diagnosis, classification of disease severity, treatment) in the intervention commune and five comparison communes, using a quasi-experimental study design and relying on routinely collected programmatic data. Average per capita monthly under-five visits were 0.28 in the intervention commune and 0.22 in the comparison communes. In the intervention commune, 40.0% of visits were completed at the household via proactive care. CHWs completed all steps of the iCCM protocol in 77.8% of observed visits in the intervention commune (vs 49.5% in the comparison communes, p-value=<0.001). A two-pronged approach to CH delivery and professionalization of the CHW workforce increased utilization and demonstrated satisfactory quality of care. National stakeholders and program managers should evaluate program re-design at a local level prior to national or district-wide scale-up.

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