Identification of Prognostic Factors in Early Unfavorable Stage Hodgkin’s Lymphoma (HL): An Individual Patient Data Meta-Analysis.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2473-2473 ◽  
Author(s):  
Julia Bohlius ◽  
Heinz Haverkamp ◽  
Volker Diehl ◽  
Houchingue Eghbali ◽  
Christopher Ferme ◽  
...  
Keyword(s):  
Risk Factors ◽  
Mediastinal Tumor ◽  
Proportional Hazards ◽  
Individual Patient Data ◽  
Early Stage ◽  
Collaborative Study ◽  
Patient Data ◽  
Stage I ◽  
Cochrane Library ◽  
Treatment Optimization

Abstract Background: In patients with early unfavorable stage HL, generally defined as stage I and II patients with mediastinal bulk, elevated ESR, 3 3 involved nodal regions, older age or extranodal involvement, progression-free-survival (PFS) is low compared to patients with early favorable or advanced stages disease. This indicates suboptimal treatment strategies and clinical heterogeneity within the group of patients with early unfavorable stage HL. An international collaborative study was initiated to identify factors that may predict for poor prognosis in this patient group. Methods: Medline and Cochrane Library were systematically searched for randomized controlled trials (n>100 patients per study arm) in early stage HL patients with one or more risk factors receiving 4–6 cycles of ABVD or similar chemotherapy plus radiotherapy. Individual patient data were collected and risk factors for PFS (including disease progression, relapse or death) identified using multivariate analysis (linear stepwise proportional hazards) stratified by study. Results: Six studies were identified; data from 4,490 adult patients enrolled between 08/1982 and 01/2003 were available for analysis. The median follow up was 64 months; 663 patients experienced an event leading to an overall 5-year PFS rate of 85% (95% CI 83%–88%). Six factors were significantly (P<0.01) associated with poor PFS: male gender (Hazard ratio (HR) 1.69), age (HR per additional life year 1.03), B symptoms (HR 1.25), anemia (HR per 1 g/dL Hb decrease 1.09), WBC (HR per 1000 WBC increase 1.02) and large mediastinal tumor (HR 1.54). Split into quintiles by predicted risk, observed 5-year PFS rates differed significantly (p<0.001): 80% of patients with early unfavorable stage HL achieved 5-year PFS rates ranging from 84% (95% CI 81%–87%) to 92% (95% CI 90%–94%) while 20% of patients had poor 5-year PFS, i.e. 76% (95% CI 73%–79%). Compared to low risk patients, those with high risk were more often male (81% vs 40%), older (median age 50 vs 29 years) and presented more often with B symptoms (62% vs 28%) and large mediastinal tumor (42% vs 27%). These data show that among stage I and II patients with at least one risk factor heterogeneity exists. Conclusion: Using basic characteristics and routine tests, it is possible to identify a subgroup of early unfavorable stage patients with poor PFS while receiving 4–6 cycles of ABVD or similar chemotherapy plus radiotherapy. For these patients, treatment optimization is open to discussion in particular when compared to that of patients with advanced stage disease.

Identification of Prognostic Factors in Patients with Early Stage Unfavorable Hodgkin’s Lymphoma: An Individual Patient Data Meta-Analysis.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5577-5577
Author(s):  
Julia Bohlius ◽  
Heinz Haverkamp ◽  
Volker Diehl ◽  
Houchingue Eghbali ◽  
Jeremy Franklin ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Missing Data ◽  
Hodgkin’S Lymphoma ◽  
Individual Patient Data ◽  
Early Stage ◽  
Patient Data ◽  
Hodgkin's Lymphoma ◽  
Cochrane Library ◽  
Bulky Disease ◽  
Laboratory Parameters

Abstract Background: In patients with early stage unfavorable Hodgkin’s lymphoma (HL) event-free-survival (EFS) is low compared to patients with early favorable or advanced stage disease. An international collaborative study was initiated to identify prognostic factors that could help to define among early stage unfavorable patients those who might benefit from more intensive treatment. Methods: Medline and Cochrane Library were systematically searched for randomized controlled trials in stage I/II HL. Trials should concern patients with one or more risk factors (age, sex, stage, B-symptoms, bulky disease, number of areas involved, laboratory parameters) receiving 4–6 cycles of ABVD or similar chemotherapy and radiotherapy. Only trials with ≥ 100 patients per study arm were considered. Individual patient data were collected. Results: Six studies were identified: GHSG: HD5, HD8, HD11; EORTC: H6U, H7U, H8U. Data from 4,235 patients enrolled between 08/1982 and 01/2003 were available for analysis. The proportion of missing data was very low for demographic and clinical characteristics (&lt; 1%); it was acceptable (1.5–9%) for laboratory parameters with the exception of albumin (41% missing values, not recorded in 3 trials). Patient characteristics are listed below. The median follow up was 58.4 months (95% CI 56–61). At the time of analysis 612 patients had experienced an event (disease progression, relapse or death) leading to a 5-year EFS rate of 85%. Using an univariate Cox-regression stratified by study and treatment arm several parameters showed significant influence on EFS. Conclusion: The data set available is sufficiently powered to identify relevant prognostic factors. A multivariate analysis using updated data will be presented. Baseline parameter of inlcuded studies Age (median years) Male sex Sage (I/II) B symptoms Bulky disease Hb (median g/dL) All patients, n=4,325 32 2,039 (48.1%) I: 546 (12.9%), II: 3,688 (87.1%) 1,490 (35.2%) 1,936 (45.7%) 12.9 Missing data 1 (&lt; 1%) 0 1 (&lt; 1%) 35 (&lt; 1%) 0 82 (1.9%)

scholarly journals Self-monitoring of Blood Pressure in Patients With Hypertension-Related Multi-morbidity: Systematic Review and Individual Patient Data Meta-analysis

2019 ◽  
Author(s):  
J P Sheppard ◽  
K L Tucker ◽  
W J Davison ◽  
R Stevens ◽  
W Aekplakorn ◽  
...  
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
High Intensity ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Cochrane Library ◽  
Self Monitoring ◽  
Co Morbidity

Abstract BACKGROUND Studies have shown that self-monitoring of blood pressure (BP) is effective when combined with co-interventions, but its efficacy varies in the presence of some co-morbidities. This study examined whether self-monitoring can reduce clinic BP in patients with hypertension-related co-morbidity. METHODS A systematic review was conducted of articles published in Medline, Embase, and the Cochrane Library up to January 2018. Randomized controlled trials of self-monitoring of BP were selected and individual patient data (IPD) were requested. Contributing studies were prospectively categorized by whether they examined a low/high-intensity co-intervention. Change in BP and likelihood of uncontrolled BP at 12 months were examined according to number and type of hypertension-related co-morbidity in a one-stage IPD meta-analysis. RESULTS A total of 22 trials were eligible, 16 of which were able to provide IPD for the primary outcome, including 6,522 (89%) participants with follow-up data. Self-monitoring was associated with reduced clinic systolic BP compared to usual care at 12-month follow-up, regardless of the number of hypertension-related co-morbidities (−3.12 mm Hg, [95% confidence intervals −4.78, −1.46 mm Hg]; P value for interaction with number of morbidities = 0.260). Intense interventions were more effective than low-intensity interventions in patients with obesity (P &lt; 0.001 for all outcomes), and possibly stroke (P &lt; 0.004 for BP control outcome only), but this effect was not observed in patients with coronary heart disease, diabetes, or chronic kidney disease. CONCLUSIONS Self-monitoring lowers BP regardless of the number of hypertension-related co-morbidities, but may only be effective in conditions such obesity or stroke when combined with high-intensity co-interventions.

Predictive factors for metastasis in patients (pts) with gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15056-15056
Author(s):  
S. Kilickap ◽  
O. Dizdar ◽  
H. Harputluoglu ◽  
S. Aksoy ◽  
S. Yalcin
Keyword(s):  
Risk Factors ◽  
Gastric Cancer ◽  
Early Stage ◽  
Stage Iv ◽  
Stage I ◽  
Early Stage Disease ◽  
Increased Risk ◽  
Metastasis Development ◽  
The Mean

15056 Background: Determination of patients (pts) with early stage disease who have a high risk for developing metastatic disease is crucial. We investigated the risk factors associated with metastases development in pts with operable gastric cancer. Patients and Methods: In this retrospective study, pts with stage I-III and non-metastatic stage IV gastric cancer diagnosed between 1990 and 2006 were evaluated. The medical records of all pts including patient characteristics, laboratory results, histopathological examinations, were reviewed. Logistic regression methods were used to determine the risk factors for developing metastasis and to calculate odds ratios (OR) with 95% confidence intervals (CI). Results: 184 pts (70% male, 30% female) were analyzed. The mean age ± standard deviation was 56.5±11.9. The mean age of female were higher than male (p=0.014). At the time of diagnosis, 13.6% of the pts had stage I, 19.0% had stage II, 53.3% had stage III, and 14.1% had non-metastatic stage IV disease. The tumors were distally localized in 80% of the cases. Median follow-up period was 35 months. During follow up, 51 pts developed metastases. Median time to metastases development was 14 months. Overall survival was shorter in pts who developed metastasis than those who did not. (20 months vs. not reached, respectively, p=0.002). In univariate analyses, stage (p=0.020), tumor localization (p=0.006), extracapsular lymphatic extension (ELE) (p<0.001), the number of metastatic lymph nodes (p=0.001), CEA level (p<0.001), lymphovascular invasion (LVI) (p=0.001), and perineural invasion (p=0.007) were associated with metastasis development. In multivariate analysis, elevated CEA levels (p=0.009; OR: 2.8; CI 95%: 1.29–6.19), LVI (p=0.041; OR: 2.2; CI 95%: 1.03–4.64) and ELE (p=0.029; OR: 2.3; CI 95%: 1.09–4.78) were associated with increased risk of metastasis development while distal localization (p=0.038; OR: 0.42; CI%: 0.18–0.95) was associated with decreased risk in pts with gastric cancer. Discussion: In pts with early stage or locally advanced gastric cancer, elevated CEA levels, LVI, proximal localization and ELE were associated with increased risk of developing metastasis. Aggressive treatment options and closer follow up should be considered for pts with these risk factors. No significant financial relationships to disclose.

Effects of metformin and sulfonylureas on overall and colorectal cancer-specific mortality.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 2599-2599
Author(s):  
Susan Spillane ◽  
Kathleen Bennett ◽  
Linda Sharp ◽  
Thomas Ian Barron
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Proportional Hazards ◽  
Early Stage ◽  
Population Based ◽  
Cox Proportional Hazards ◽  
Stage I ◽  
Early Stage Disease ◽  
All Cause Mortality ◽  
Specific Mortality

2599 Background: Preclinical studies have suggested a role for metformin in the treatment of colorectal cancer (CRC). Associations between metformin versus sulfonylurea exposure and mortality (all-cause and colorectal cancer specific) are assessed in this population-based study of patients with a diagnosis of stage I-IV CRC. Methods: National Cancer Registry Ireland records were linked to prescription claims data and used to identify a cohort of patients with incident TNM stage I-IV CRC diagnosed 2001-2006. From this cohort, 2 patient groups were identified and compared for outcomes - those who received a prescription for metformin +/- a sulfonylurea (MET) or a prescription for sulfonylurea alone (SUL) in the 90 days pre CRC diagnosis. Adjusted hazard ratios (HR) with 95% confidence intervals (CI) were estimated using Cox proportional hazards models adjusted for age, sex, stage, grade, site, comorbidities, year of diagnosis, and insulin, aspirin or statin exposure. Analyses were repeated stratifying by stage and site. Results: 5,617 patients with stage I-IV CRC were identified, of whom 369 received a prescription for metformin or a sulfonylurea in the 90 days pre diagnosis (median follow-up 1.6 years; MET: n=257; SUL: n=112). In adjusted analyses metformin exposure was associated with a 28% lower risk of all-cause mortality relative to sulfonylurea exposure (HR 0.72, 95% CI 0.53-0.98) and a non-significant 24% reduction in CRC-specific mortality (HR 0.76, 95% CI 0.52-1.13). In analyses stratified by site, in colon cancer, metformin exposure was associated with a significant one-third reduction in all-cause mortality (HR 0.66, 95% CI 0.46-0.95) and a non-significant reduction in site-specific mortality (HR 0.64, 95% CI 0.40-1.02). No mortality benefit was observed for rectal cancer. The association between metformin exposure and reduced mortality was strongest for stage I/II disease (all-cause mortality: HR 0.56, 95% CI 0.32-0.98; CRC-specific mortality: HR 0.48, 95% CI 0.21-1.11). Conclusions: Pre-diagnosis metformin exposure in CRC patients was associated with a significant reduction in mortality relative to sulfonylurea exposure. This benefit was greatest in patients with colon cancer and early stage disease.

Circulating tumor cell status and benefit of radiotherapy in stage I breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 11524-11524
Author(s):  
Chelain Rae Goodman ◽  
Brandon-Luke L Seagle ◽  
Eric Donald Donnelly ◽  
Jonathan Blake Strauss ◽  
Shohreh Shahabi
Keyword(s):  
Breast Cancer ◽  
Tumor Cell ◽  
Proportional Hazards ◽  
Early Stage ◽  
Cohort Analysis ◽  
Metastatic Breast ◽  
Circulating Tumor Cell ◽  
Cox Proportional Hazards ◽  
Stage I ◽  
Matched Cohort

11524 Background: Circulating tumor cell (CTC) status has been shown to be prognostic of decreased survival in non-metastatic breast cancer. While up to 20-30% of patients with early breast cancer have detectable CTCs, less is known regarding the role of CTC-status in guiding clinical management. Methods: An observational cohort study was performed on women with stage I breast cancer evaluated for CTCs from the 2004-2014 National Cancer Database. Logistic regression was used to explore clinicopathological associations with CTC-status. Kaplan-Meier and multivariable Cox proportional-hazards survival analyses were used to estimate associations of CTC-status with overall survival using a propensity score-adjusted and inverse probability-weighted matched cohort. Results: Of the stage I breast cancer women evaluated for CTCs, 23.1% (325/1,407) were CTC-positive. Age, histology, receptor status, and nodal stage were associated with CTC-status. CTC-status was an effect modifier of the radiotherapy-survival association: CTC-positive women who did not receive radiotherapy had an increased hazard of death compared to CTC-negative women who also did not receive radiotherapy (four-year survival: 85.7% vs. 93.3%, HR = 2.92, CI = 1.43-5.98, P = 0.003). CTC-positive patients treated with radiotherapy did not have decreased survival compared to CTC-negative patients not treated with radiotherapy (HR = 0.67, CI = 0.28-1.65, P = 0.40). From the matched cohort analysis, CTC-positive women who did not receive radiation had a 4.82-fold increased hazard of death compared to CTC-positive women treated with radiotherapy (four-year survival: 83.2% vs. 96.6%; CI = 2.62-8.85, P < 0.001). Conclusions: Treatment with adjuvant radiotherapy was associated with improved survival in CTC-positive women with stage I breast cancer. If prospectively validated, CTC-status may be valuable as a predictor of benefit of radiotherapy in early stage breast cancer.

Race as an independent factor for survival in breast cancer patients according to analysis of the National Cancer Database (NCDB).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18155-e18155 ◽  
Author(s):  
Drew Carl Drennan Murray ◽  
Shruti Bhandari ◽  
Phuong Ngo ◽  
Sarah Mudra ◽  
Rachana Shirish Lele ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Proportional Hazards ◽  
Early Stage ◽  
Tumor Biology ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards ◽  
Independent Factor ◽  
Breast Cancer Patients ◽  
Delayed Treatment

e18155 Background: Black (B) women after early stage of diagnosis have been shown to have double the risk of white (W) women for failing to receive adjuvant chemotherapy. Despite lower incidence of breast cancer in B patients, they are more likely to die of the disease. Worse outcomes in B populations have been related to clinical and socioeconomic factors. However, the determination of improved access and its effects on survival in black patients remains uncertain. Methods: 1042844 patients diagnosed between 2004 and 2014 with stage I-III breast cancer were identified in the NCDB. Only W and B races were analyzed with established risk factors of age, stage, comorbidity score, and insurance status. Data was analyzed using univariable and multivariable logistic and Cox proportional hazards regression models. Odds Ratio (OR) for binary outcome, Hazard Ratio (HR) for time-to-event (survival) outcome along with 95% confidence interval (95% CI) are reported. Results: Among the total population 85.5% were W, 10.6% B, and 3.9% other. B were more likely to be uninsured (OR: 1.66; 95% CI: 1.59 - 1.72; p < 0.0001), or have Medicaid (OR: 2.01; 95% CI: 1.96 - 2.07; p < 0.0001). B were also diagnosed at later stage (stage 3 OR: 1.59; 95% CI: 1.57 - 1.63; p < 0.0001) with higher co-morbidities (OR: 2.49; 95% CI: 2.34 - 2.67; p < 0.0001) consistent with prior studies. B were more likely to experience delayed treatment (OR: 2.15; 95% CI: 2.10 - 2.20; p < 0.0001). B race remained an independent factor associated with higher likelihood of death compared to W patients (HR: 1.32; 95% CI: 1.3 - 1.34; p < 0.0001) in multivariable analysis. Conclusions: This large database study demonstrates that even when controlling for established risk factors such lack of insurance or Medicaid, higher comorbidities, and later stage at diagnosis, B patients were more likely to experience delays in treatment initiation and worse overall survival. This suggests race remains an independent risk factor for poor outcome even when clinical factors are matched. Further analysis including tumor biology should be examined to better understand this persistent disparity.

scholarly journals Radical Versus Non-Radical Resection for Early-Stage Retroperitoneal Sarcoma: A Propensity Score-Matched Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Chengxin Weng ◽  
Jiarong Wang ◽  
Jichun Zhao ◽  
Ding Yuan ◽  
Bin Huang ◽  
...  
Keyword(s):  
Propensity Score ◽  
Proportional Hazards ◽  
Early Stage ◽  
Radical Resection ◽  
Cox Proportional Hazards ◽  
Retroperitoneal Sarcoma ◽  
Stage I ◽  
National Database ◽  
Cox Proportional Hazards Models ◽  
Overall Mortality

BackgroundThe appropriate surgical procedure for early-stage retroperitoneal sarcoma (RPS) is unclear. Thus, we used a national database to compare the outcomes of radical and non-radical resection in patients with early stage RPS.MethodsThis retrospective study included 886 stage I RPS patients from 2004 to 2015 in the SEER database. Outcomes were compared using the multivariate Cox proportional hazards models and the results were presented as adjusted hazards ratio (AHR) with corresponding 95% confidence intervals (95%CIs). Propensity score-matched analyses were also performed for sensitive analyses.ResultsFor the 886 stage I RPS patients, 316 underwent radical resection, and 570 underwent non-radical resection, with a median follow-up of 4.58 (2.73-8.35) years. No difference was observed in overall mortality (AHR 0.84, 95%CI 0.62-1.15; P = 0.28) or RPS-specific mortality (AHR 0.88, 95%CI 0.57-1.36; P = 0.56) between groups. The results were similar in propensity score-matching analyses. However, subgroup analysis revealed that radical resection was associated with significantly decreased risks of overall mortality in male (AHR 0.61, 95%CI 0.38-0.98; P = 0.04) and in patients with radiotherapy (AHR 0.56, 95%CI 0.32-0.98; P = 0.04).ConclusionRadical resection did not improve midterm survival outcomes compared with non-radical resection in overall patients with early stage RPS. However, male patients or patients who received radiotherapy might benefit from radical resection with improved overall survival.

scholarly journals Clinicoradiological features and surgical outcomes of primary intracranial medulloepitheliomas: a single-center experience and pooled analysis of individual patient data

2019 ◽  
Vol 130 (5) ◽  
pp. 1553-1567
Author(s):  
Da Li ◽  
Shu-Yu Hao ◽  
Liang Wang ◽  
Gui-Lin Li ◽  
Jun-Mei Wang ◽  
...  
Keyword(s):  
Risk Factors ◽  
Total Dose ◽  
Individual Patient Data ◽  
Cox Model ◽  
Treatment Protocol ◽  
Pooled Analysis ◽  
Patient Data ◽  
Optimal Treatment ◽  
Cystic Degeneration

OBJECTIVEMedulloepithelioma (MEPL) is a rare, malignant primitive neuroectodermal tumor with dismal survival rates. The authors aimed to define independent risk factors for progression-free survival (PFS) and overall survival (OS) and to propose an optimal treatment protocol for MEPL.METHODSThe authors reviewed the clinicoradiological data obtained in 12 patients with MEPL who underwent surgical treatment at their institution between January 2008 and June 2016. In addition, they reviewed 55 cases of MEPL published in the literature from January 1957 to July 2017. A pooled analysis of individual patient data of these 67 patients was performed to evaluate risk factors.RESULTSThe authors’ cohort included 5 males and 7 females with a mean age of 15.7 years. Gross-total resection (GTR) was achieved in 10 (83.3%) patients. Radiotherapy (mean total dose 42.8 Gy) and chemotherapy were administered to 7 and 4 patients, respectively. After a median follow-up of 21.7 months, 6 (50%) patients suffered recurrence and subsequently died, with median PFS and OS times of 5.5 and 13.9 months, respectively. Among the 55 patients in the literature, 13 (23.6%) patients received GTR, and 25 (49.0%) and 15 (29.4%) received radiotherapy (median total dose 53.2 Gy) and chemotherapy, respectively. After a median follow-up of 10.0 months, the recurrence and mortality rates were 69.7% (23/33) and 70.8% (34/48), respectively, and the median PFS was 6.0 months. Of the pooled cohort, the actuarial 5-year PFS and OS were 36.3% and 29.2%, respectively, and the estimated median survival time for PFS and OS were 12.8 and 15.2 months, respectively. A multivariate Cox model verified non-GTR (HR 5.537, p < 0.001) and no radiotherapy (HR 3.553, p = 0.008) as independent adverse factors for PFS. The 5-year PFS in patients with or without GTR was 63.8% and 6.3%, respectively, and in patients with or without radiotherapy was 42.7% and 23.1%, respectively. A multivariate model demonstrated non-GTR (HR 9.089, p < 0.001), no radiotherapy (HR 3.126, p = 0.004), and no chemotherapy (HR 3.621, p = 0.004) as independent adverse factors for poor OS. The 5-year OS in patients with GTR, radiotherapy, or chemotherapy was 72.1%, 44.0%, and 58.0%, respectively. In contrast, in patients without GTR, radiotherapy, or chemotherapy, the 5-year OS was 5.8%, 14.3%, and 15.8%, respectively. Overall, in patients receiving GTR plus chemoradiotherapy, the actuarial 5-year PFS and OS were both 87.5%.CONCLUSIONSMEPL is a rare neoplastic entity with a poor prognosis. There are no distinguishing radiological features apart from cystic degeneration. Via the pooled analysis, the authors identified independent adjustable factors associated with PFS and OS, from which they advocate for GTR plus chemoradiotherapy with a sufficient dose if tolerable as an optimal treatment to improve outcomes. Future studies with large cohorts will be necessary to verify our findings.

scholarly journals Efficacy of artemisinin-based and quinine-based treatments for uncomplicated falciparum malaria in pregnancy: a protocol for systematic review and individual patient data (IPD) meta-analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e027503 ◽  
Author(s):  
Makoto Saito ◽  
Rashid Mansoor ◽  
Kalynn Kennon ◽  
Rose McGready ◽  
François Nosten ◽  
...  
Keyword(s):  
Risk Factors ◽  
Treatment Failure ◽  
Falciparum Malaria ◽  
Treatment Efficacy ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Malaria In Pregnancy ◽  
Uncomplicated Falciparum Malaria ◽  
In Pregnancy

IntroductionPregnant women are more vulnerable to malaria leading to adverse impact on both mothers and fetuses. However, knowledge on the efficacy and safety of antimalarials in pregnancy is limited by the paucity of randomised control trials and the lack of standardised protocols in this special subpopulation. Pooling individual patient data (IPD) for meta-analysis could address in part these limitations to summarise accurately the currently available evidence on treatment efficacy and risk factors for treatment failure.Methods and analysisTo assess the treatment efficacy of artemisinin-based and quinine-based treatments for uncomplicated falciparum malaria in pregnancy, seven databases (Medline, Embase, Global Health, Cochrane Library, Scopus, Web of Science and Literatura Latino Americana em Ciências da Saúde) and two clinical trial registries (International Clinical Trials Registry Platform and ClinicalTrial.gov) were searched. Both interventional and observational cohort studies following up for at least 28 days will be included. IPD of the identified eligible published or unpublished studies will be sought by inviting principal investigators. Raw IPD will be shared through the web-based secure platform developed by the WorldWide Antimalarial Resistance Network using the established methodology. The primary objective is to compare the risk of PCR-corrected treatment failure among different treatments and to find the risk factors. One-stage IPD meta-analysis by Cox model with shared frailty will be conducted. A risk of bias assessment will be conducted to address the impact of unshared potential data and of the quality of individual studies. Potential limitations include difficulty in acquiring the IPD and heterogeneity of the study designs due to the lack of standard.Ethics and disseminationThis IPD meta-analysis consists of secondary analyses of existing anonymous data and meets the criteria for waiver of ethics review by the Oxford Tropical Research Ethics Committee. The results of this IPD meta-analysis will be disseminated through open-access publications at peer-reviewed journals. The study results will lead to a better understanding of malaria treatment in pregnancy, which can be used for clinical decision-making and conducting further studies.PROSPERO registration numberCRD42018104013.

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