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Objectives To develop and validate a nomogram based on fetal nuchal translucency thickness (NT) and ultrasonographic facial markers for screening for trisomy 21 in the first trimester of pregnancy. Methods This was a retrospective case–control study using stored two‐dimensional midsagittal fetal profile images captured at 11 + 0 to 13 + 6 weeks' gestation in singleton pregnancies. We included images from 302 trisomy‐21 pregnancies and 322 euploid pregnancies. Cases were divided into a training set (200 euploid + 200 with trisomy 21) and a validation set (122 euploid + 102 with trisomy 21) at a ratio of approximately 2:1. For each, the maternal age, gestational age, fetal NT and karyotype were noted, and 12 ultrasonographic fetal facial markers were measured. The least absolute shrinkage and selection operator (LASSO) method and multivariable analysis were used to select automatically the discriminative markers. Logistic regression was used to develop a LASSO model, based on the selected markers, to screen for trisomy 21 in the first trimester of pregnancy. Furthermore, 60 of the 624 images were selected randomly as a retest set to evaluate the model's robustness. The predictive performance of screening for trisomy 21 of a model based on fetal NT and maternal age and of the LASSO model was assessed using the area under the receiver‐operating‐characteristics curve (AUC). A nomogram was developed as an individualized tool to predict patient‐specific probability for trisomy 21, which is a more visual presentation of the LASSO model. The performance of the nomogram was assessed using the C‐index and calibration curve. Results Into the LASSO model were incorporated eight markers, including fetal NT, prenasal‐thickness‐to‐nasal‐bone‐length ratio, facial profile line, frontomaxillary facial angle, frontonasal facial angle, mandibulomaxillary facial angle, maxilla‐nasion‐mandible angle and d2 (distance between the anterior edge of the prefrontal skin and the mandibulomaxillary line) (all P

Background and aims Acute-on-chronic liver failure (ACLF) is associated with bacterial infection and poor outcome. Neutrophil-to-lymphocyte ratio (NLR) is used to assess bacterial infection and immune dysfunction in numerous diseases. We aimed to evaluate NLR as a prognostic biomarker and to explore its combination with accepted prognostic models in ACLF patients. Methods This retrospective study included patients with ACLF or severe liver injury from chronic HBV infection admitted to three tertiary academic hospitals in China from 2013 to 2019. Baseline NLR was correlated with ACLF grade, bacterial infection, survival and accepted ACLF scores. Results NLR values were significantly increased in nonsurvivors and patients with bacterial infection at or after admission and were unaffected by cirrhotic status in 412 transplant-free patients included in three cohorts. Compared with accepted scores, NLR showed moderate accuracy in predicting 28-day mortality and high accuracy in predicting 90-day mortality. Three levels of mortality risk were graded on the basis of NLR values ( 4.79), and NLR >4.79 was associated with 53.2-60.0% 28-day and 75.0-80.0% 90-day mortality in these cohorts. Multivariate analyses indicated that NLR retained statistical significance independently of CLIF consortium organ failure score (CLIF-C OFs). NLR-based CLIF-C ACLF score was primarily developed and showed excellent performance in predicting 28/90-day mortality. Conclusions NLR is a dependable biomarker for bacterial infection assessment and short-term mortality prediction in ACLF patients and can be used jointly with CLIF-C OFs to improve the accuracy of mortality prediction in patients with the disease. NLR-based CLIF-C ACLF model needs further validation.

To investigate the efficacy, safety and the risk factors affecting prognosis of high-risk acute myeloid leukemia (AML) patients treated by cladribine-based intensified conditioning regimen.The clinical data of 28 patients with high-risk AML treated by cladribine in combination with busulfan plus cyclophosphamide (BuCy) intensified conditioning regimen before allogeneic hematopoietic stem cell transplantation (allo-HSCT) in Zhujiang Hospital, Southern Medical University from October 2016 to June 2020 were analyzed retrospectively. The overall survival (OS) rate, cumulative progression-free survival (PFS) rate, relapse rate, non-relapse mortality (NRM), regimen related toxicity (RRT) and risk factors affecting prognosis of the patients were analyzed.The 1-year OS and PFS of the patients after implantation was (78.8±8.6)% and (79.8±8.1)%, while the 1-year cumulative relapse rate and NRM of the patients was 9.3% and 22.0%, respectively. The 1-year expected OS of MRDThe intensified conditioning regimen of cladribine in combination with BuCy can reduce the relapse rate of high-risk AML transplantation, and its RRT is mild, exhibiting good safety. MRD含克拉屈滨的强化预处理方案在异基因造血干细胞移植治疗 高危急性髓系白血病患者中的疗效和安全性分析.探讨含克拉屈滨的强化预处理方案在治疗高危急性髓系白血病（AML）患者中的疗效、安全性及影响预后的危险因素.回顾性分析2016年10月至2020年6月于南方医科大学珠江医院行异基因造血干细胞移植前接受克拉屈滨联合白消安及环磷酰胺（BuCy）强化预处理方案的28例高危AML患者临床资料，分析移植后累积总生存率（OS）、累积无进展生存率（PFS）、复发率、非复发死亡率（NRM）、预处理相关毒性反应（RRT）以及影响预后的危险因素.移植后1年的预期累积OS和PFS分别为（78.8±8.6）%和（79.8±8.1）%，1年累积复发率和NRM分别为9.3%和22.0%。移植前MRD克拉屈滨联合BuCy的强化预处理方案降低了高危AML移植后复发率，且其预处理相关毒性轻、安全性良好。移植前MRD

To investigate the efficacy of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the treatment of acute monocytic leukemia (AML-M5) and the related factors that affecting the prognosis of the patients.The clinical data of 71 patients with AML-M5 treated with allo-HSCT in Zhujiang Hospital Affiliated to Southern Medical University from April 2009 to October 2019 were collected and retrospectively analyzed. The incidence of graft-versus-host disease (GVHD), cumulative overall survival (OS) rate, cumulative progression-free survival (PFS) rate, transplantation-related mortality (TRM), relapse rate and the risk factors affecting prognosis in the patients were analyzed.66 patients obtained hematopoietic reconstruction after transplantation, the median time of granulocyte implantation was 12 (9-26) d, and the median time of megakaryocytic implantation was 13 (8-72) d. The incidence of acute GVHD and chronic GVHD was 33.8% (24/71) and 36.6% (26/71), respectively. The median follow-up time was 13.81 (0.16 to 112.54) months; the median OS and PFS was 31.27 and 26.07 months, respectively. The cumulative OS of the patients in 1 and 3 years after transplantation was 64.9% and 48.6%, respectively, and the cumulative PFS of the patients in 1 and 3 years was 55.0% and 39.5%, respectively. The cumulative relapse rate of the patients in 1 and 3 years was 24% and 40%, respectively. Multivariate analysis showed that pre-transplantation relapse was the independent risk factor affecting OS (HR=2.32, 95%CI:1.17-4.62, P=0.02) and PFS (HR=3.08, 95%CI:1.61-5.90, P=0.001) of the patients; invasive fungal disease after transplantation was the independent risk factor affecting OS (HR=2.71, 95% CI:1.32-5.56, P=0.007) and PFS (HR=2.87, 95%CI=1.40-5.86, P=0.004) of the patients; FLT3 mutation was the independent risk factor affecting PFS (HR=2.13, 95%CI=1.07-4.24, P=0.03) of the patients.AML-M5 is the intermediate or high-risk leukemia, and allo-HSCT can improve the survival prognosis of the patients. Pre-transplantation relapse and invasive fungal disease after transplantation are the important factors affecting the efficacy of allo-HSCT in patients with AML-M5.异基因造血干细胞移植治疗急性单核细胞白血病患者的疗效及预后分析.探讨异基因造血干细胞移植（allo-HSCT）治疗急性单核细胞白血病（AML-M5）患者的疗效及影响预后的相关因素.收集2009年4月至2019年10月于南方医科大学珠江医院行allo-HSCT治疗的AML-M5患者71例的临床资料。分析患者移植物抗宿主病发生率、移植后累积总生存（OS）率、累积无进展生存（PFS）率、移植相关死亡（TRM）率、复发率以及影响预后的危险因素.移植后，66例患者获得造血重建，粒系植入中位时间12（9-26）d，巨核系植入中位时间13（8-72）d。急、慢性移植物抗宿主病的发生率分别为33.8%（24/71）和36.6%（26/71）。中位随访时间为13.81（0.16-112.54）个月；中位OS和PFS时间分别为31.27和26.07个月。移植后1年和3年累积OS率分别为64.9%和48.6%，1年和3年累积PFS率分别为55.0%和39.5%。1年和3年累计复发率分别为24%和40%。多因素分析显示，移植前复发是影响患者OS（HR=2.32，95%CI:1.17-4.62，P=0.02）和PFS（HR=3.08，95%CI:1.61-5.90，P=0.001）的独立危险因素；移植后真菌感染是影响患者OS（HR=2.71，95%CI:1.32-5.56，P=0.007）和PFS（HR=2.87，95%CI:1.40-5.86，P=0.004）的独立危险因素；FLT3突变是影响患者PFS（HR=2.13，95%CI=1.07-4.24，P=0.03）的独立危险因素.AML-M5属于中高危白血病，allo-HSCT能改善患者的生存及预后。移植前复发和移植后真菌感染是影响allo-HSCT疗效的重要因素.

Children with long-term tracheostomies are at higher risk of complications. This study aims to describe the epidemiology, outcomes, and factors associated with successful decannulation in children undergoing tracheostomy.Case series with chart review.Tertiary hospital.A retrospective analysis was conducted on pediatric tracheostomies performed from 2006 to 2016. Demographics, preexisting comorbidities, indications for tracheostomy, and pretracheostomy ventilatory requirements were collected. A multivariate regression model with covariates of age, failure to thrive (FTT), and comorbidities was used to identify factors associated with successful decannulation. Secondary outcomes were ventilation and oxygen requirements at hospital discharge, hospital and intensive care unit length of stay, and complications.In total, 105 patients received a tracheostomy at a median age of 8.0 months (interquartile range, 2.0-45.0). The most common indication was anatomic airway obstruction (55 of 105, 52.5%). Forty-four (41.9%) patients had preexisting FTT. In-hospital mortality was 14 of 105 (13.3%). None were directly related to tracheostomy. At discharge, 40 of 91 (44.0%) and 12 of 91 (13.2%) required home mechanical ventilation and supplemental oxygen, respectively. Forty-one (39%) patients underwent successful decannulation at a median 408 days (interquartile range, 170-1153) posttracheostomy. On adjusted analysis, unsuccessful decannulation was more common in patients with FTT and neurologic comorbidities. Postoperative complications were more common in younger patients and those with a longer time to decannulation.Neurologic comorbidities and FTT were risk factors for unsuccessful decannulation after pediatric tracheostomy. Nutritional interventions may have a role in improving long-term outcomes following pediatric tracheostomies and should be investigated in future studies.

Hyperglycemia in pregnancy (HIP) is related to adverse pregnancy outcomes. However, women with hyperglycemia in the second and third trimester of pregnancy (HISTTP) were not been observed. We aim to reveal associations between HISTTP and prematurity. To confirm which risk factor is better in predicting preterm delivery. This retrospective study included 660 patients, of which 132 have HISTTP and 528 have euglycemia. Univariate analysis was used to extract risk factors and multivariates logistic regression analysis to obtain odds ratio (OR) for prematurity. Mean decrease gini (MDG) in random forest algorithm was used to rank the risk factors. HISTTP women have higher prepregnancy BMI and a higher percentage of family history of hypertension, maternal adiposity, maternal anemia, gestational diabetes mellitus (GDM), prematurity, neonatal asphyxia in 1-minute (P

Supplemental Digital Content is available in the text, This study aimed to determine whether the addition of intracavitary brachytherapy (ICBT) to chemoradiotherapy (CRT) improves outcome in patients with cervical cancer and poor prognostic factors. Patients with stage IB to IIA cervical cancer who had undergone radical hysterectomy and pelvic lymphadenectomy between August 2008 and December 2014 were retrospectively registered in this study. All patients received external beam radiation therapy (EBRT) + chemotherapy, and some patients additionally received ICBT. EBRT consisted of 45 to 50.4 Gy delivered to the standard pelvic field in 25 to 28 fractions. Chemotherapy consisted of 2 to 4 courses of weekly cisplatin-based treatment. ICBT was delivered in 1 to 3 insertions. Ninety-seven of 163 patients received CRT, and 66 patients additionally received ICBT. During a median follow-up period of 33 months, recurrence was detected in 38 patients. The 3-year locoregional control (LRC), disease-free survival (DFS), and overall survival (OS) rates did not differ significantly between patients who did and did not receive ICBT. In subgroup analyses, fewer recurrences were seen in patients with at least 1 high-risk factor who received ICBT than in those who did not, with a significant (62%) reduction in the risk of progression or death (hazard ratio 0.384, 95% confidence interval 0.151–0.978, P = .045). The difference in OS between the CRT and CRT + ICBT subgroups was marginal (P = .064). The addition of ICBT to CRT after radical surgery significantly improves LRC and DFS rates in women with cervical cancer and at least 1 high-risk factor.

To explore the clinical effect of exercise rehabilitation during perioperative period on residual pain, gait and activities of daily living (ADL) in patients with lumbar spinal stenosis (LSS) after lumbar percutaneous transforaminal endoscopic discectomy(PTED).The clinical data of 48 patients with LSS underwent PTED from December 2015 to December 2016 were retrospectively analyzed. Patients were divided into observation group and control group according to different rehabilitation patterns, being 24 cases in each group. The patients of observation group received exercise rehabilitation and the patients of control group received conventional rehabilitation. Visual analogue scale(VAS), Oswestry Disability Index (ODI) and the ratio of supporting phase were recorded before operation and 12 days, 6 months after operation. The correlation between the ratio of supporting phase and VAS, ODI was analyzed.The ratio of supporting phase of observation group was significantly higher than that of control group at 12 days after operation(Lumbar percutaneous transforaminal endoscopic discectomy combined with exercise rehabilitation during the perioperative period can release or eliminate postoperative residual pain, improve gait balance, enable activities of daily living, and has a positive effect in patients with lumbar spinal stenosis.

Estrogen-related genes and the fat mass and obesity-associated (FTO) gene play a critical role in estrogen metabolism, and those polymorphisms are associated with a poor prognosis in breast cancer. However, little is known about the association between these polymorphisms and the efficacy of anastrozole. The aim was to investigate the impact of the genetic polymorphisms, CYP19A1, 17-β-HSD-1 and FTO, on the response to anastrozole in metastatic breast carcinoma (MBC) and to evaluate the impact of those polymorphisms on various clinicopathologic features. Two-hundred seventy-two women with hormone receptor-positive MBC treated with anastrozole were identified retrospectively. DNA was extracted from peripheral blood and genotyped for five variants in three candidate genes. Time to progression was improved in patients carrying the variant alleles of rs4646 when compared to patients with the wild-type allele (16.40 months versus 13.52 months; p = 0.049). The rs4646 variant alleles were significantly associated with longer overall survival (37.3 months versus 31.6 months; p = 0.007). This relationship was not observed with the rs10046, rs2830, rs9926298 and rs9939609 polymorphisms. The findings of this study indicate that rs4646 polymorphism in the CYP19A1 gene may serve as a prognostic maker of the response to anastrozole in patients with MBC who are treated with anastrozole.

AIM To examine the clinical features and risk factors for adverse outcomes in chronic hepatitis B (CHB) superimposed with hepatitis E virus (HEV). METHODS This retrospective cohort study included 228 patients with acute HEV infection (showing clinical acute hepatitis symptomology and positivity for anti-HEV immunoglobulin M) with underlying CHB (confirmed by positivity for hepatitis B surface antigen and/or hepatitis B virus (HBV) DNA over 6 mo) who had been admitted to the Shanghai Public Health Clinical Center, which represents the regional tertiary hospital for infectious diseases in Shanghai city, China. Data for adverse outcomes were collected, and included severe liver diseases (defined as liver failure and/or acute liver decompensation) and liver-related mortality. Logistic regression modeling was performed to determine the risk factors for adverse outcomes. RESULTS The symptoms caused by superimposed acute hepatitis E (AHE) were much more severe in cirrhotic patients (n = 94) than in non-cirrhotic patients (n = 134), as evidenced by significantly higher liver complications (77.7% vs 28.4%, P < 0.001) and mortality rate (21.3% vs 7.5%, P = 0.002). Most of the cirrhotic patients (n = 85, 90.4%) had no prior decompensation. Among the non-cirrhotic patients, superimposed AHE caused progressively more severe diseases that corresponded with the CHB disease stages, from immune tolerant to immune reactivation phases. Few risk factors were identified in the cirrhotic patients, but risk factors for non-cirrhotic patients were found to be intermediate HBV DNA levels (OR: 5.1, P = 0.012), alcohol consumption (OR: 6.4, P = 0.020), and underlying diabetes (OR: 7.5, P = 0.003) and kidney diseases (OR: 12.7, P = 0.005). Only 28.7% of the cirrhotic patients and 9.0% of the non-cirrhotic patients had received anti-HBV therapy previously and, in all cases, the efficacy had been suboptimal. CONCLUSION CHB-related cirrhosis and intermediate HBV DNA level were associated with severe disease in superinfected patients, and successful antiviral treatment might counter this outcome.

To analyze the treatment outcome of a consecutive series of 100 leukemia patients received allogeneic hematopoietic stem cell transplantation (allo-HSCT).The clinical data of leukemia patients received allo-HSCT were analyzed retrospectively, the therapeutic efficacy was summarized. 100 evaluable cases of leukemia included 47 cases of AML, 33 cases of ALL, 2 cases of AL (biphenotypic), 16 CML and 2 CMML. Before transplantation, 76 cases were in first complete remission, 9 cases in second or greater complete remission and 15 cases in non-remission or relapse. All the patients received peripheral blood hematopoietic stem cell transplantation (PBHSCT). The conditioning regimen of human leukocyte antigen (HLA)-matched allo-HSCT group was modified BuCy, but in HLA-mismatched group Fludarabine and anti-human thymocyte globulin (ATG) was added. CsA+MTX regimen was used for prophylaxis of graft-versus-host disease (GVHD) in HLA-identical allo-HSCT, while additional MMF was added in HLA-mismatched group. The average time of follow-up was 13 months.At the last follow-up, 66.0% (66/100) patients survived, 53.0% (53/100) patients survived without leukemia, 28.0% (28/100) patients relapsed and 34.0% (34/100) patients died, 44.1% patients of them died from infectious pulmonary complications. During transplantation, 65.0% of the patients were suffered from lung infection. The overall survival (OS) and disease-free survival (DFS) of all cases was 60.9% and 48.8%, respectively. The recurrence rate was significantly higher in non-remission (66.7%) than in CR (21.2%) patients (P0.05). The cumulative incidence of GVHD in HLA-mismatched transplantation was 60.8%, which was significantly higher than that of HLA-matched transplantation (38.8%) (P0.05).Allo-HSCT can cure a significant proportion of leukemia patients, especially for those in CR status. Since the incidence of infectious pulmonary complications after allo-HSCT is still high, much more attention should be paid to it. The comprehensive prognosis of HLA-matched transplantation is better than the HLA-mis-matched transplantation.

Background and objective: Emerging evidences indicate that miR-155-5p is associated with some cancer tumorigenesis, but their specific effects on proliferation, invasion and metastasis of colorectal carcinoma (CRC) are still poorly understood. The aim of the study is to investigate miR-155-5p effect on proliferation and invasion metastasis of CRC. Methods: Retrospectively analyzed clinicopathological parameters and fresh tissue samples of 372 colon cancer patients receiving radical surgery. HT-29 cells were transfected with mimics and inhibitors of miR-155-5p, respectively. Real-time reverse transcription-PCR was performed to measure miR-155-5p relative levels of tissues and cells. Results: miR-155-5p expression in cancer group was higher than that in normal group, with statistical differences (P

ARK5 overexpression has been reported in a variety of human cancers. However, the role of ARK5 in hepatocellular carcinoma (HCC) remains unclear. The aim of the present study is to analyze the ARK5 protein expression in HCC tissue samples and to assess its prognostic significance for HCC. ARK5 mRNA and protein expression were determined by real-time quantitative reverse transcriptase–polymerase chain reaction and Western blot in 20 pairs of fresh frozen HCC tissues and corresponding non-cancerous tissues. In addition, ARK5 expression was analyzed by immunohistochemistry in 130 clinicopathologically characterized HCC cases. The correlation of ARK5 expression with patients’ survival rate was assessed by Kaplan–Meier and Cox regression. Our results showed that the expression levels of ARK5 mRNA and protein in HCC tissues were both significantly higher than those in non-cancerous tissues. Our results showed that the high expression of ARK5 in HCC was related to tumor size (p = 0.005), histological differentiation (p = 0.047), and tumor stage (p = 0.005). Kaplan–Meier survival analysis showed that a high expression level of ARK5 resulted in a significantly poor prognosis of HCC patients. Multivariate analysis revealed that ARK5 expression level was an independent prognostic parameter for the overall survival rate of HCC patients. In conclusion, ARK5 might play a positive role in tumor development and could serve as an independent predictor of poor prognosis for HCC.

To evaluate the efficacy and safety of low-dose amphotericin B (0.7 mg x kg(-1) x d(-1)) and flucytosine in patients with non-AIDS-associated cryptococcal meningitis.In non-AIDS patients with cryptococcal meningitis admitted to Huashan Hospital, Fudan University in Shanghai from January 1998 to December 2007, 31 were initially treated with low-dose amphotericin B and flucytosine for more than 1 week. The clinical characteristics, clinical responses, drug-related adverse reactions and outcome of these patients were retrospectively evaluated.Among the 31 patients enrolled in this study, 8 patients had one or more predisposing factors. Headache, fever, meningeal irritation and vomiting were common clinical symptoms and signs when cryptococcal meningitis was diagnosed. The result of cranial CT scan and/or MRI showed abnormality in 22 cases (78.6%). When the therapy of low-dose amphotericin B and flucytosine ended, the complete response rate was 19.4% (6/31), partial response rate was 54.8% (17/31), and total effective rate was 74.2%. Except for 1 patient lost to follow-up, the 1-year attributable and all-cause mortality among the remaining 30 patients were 0 (0/30) and 10.0% (3/30) respectively. On the other hand, 26 (83.9%) patients had amphotericin B-related adverse reactions, including renal impairment, liver injury, arrhythmia, and anemia, etc. However, most of these reactions were tolerable.Low-dose amphotericin B and flucytosine can be used in non-AIDS-associated cryptococcal meningitis with both acceptable efficacy and safety.

To investigate the epidemiology, clinical characteristics, therapeutic approaches and outcomes of parasitic encephalopathy.A retrospective study was carried out to analyze 78 cases of parasitic encephalopathy in Huashan Hospital between June 2003 and June 2008.There were 52 male and 26 female patients with a mean age of (34.5+/-11.4) years. Among these patients, 32.1% (25/78) had a history of eating raw, neurocysticercosis accounted for 78.2% (61/78), cerebral sparganosis 15.4% (12/78), cerebral paragonimiasis 3.8% (3/78), and cerebral toxoplasmosis 2.6% (2/78). The common clinical features were epilepsy, headache, nausea, vomiting, vision and hearing loss, facial paralysis and mental retardation. Internal medical therapy resulted in an improvement in 69.2% of the patients. 7 out of 9 patients got improved or cured by combined surgical and internal medical treatment. 42 cases were diagnosed as parasitic encephalopathy while 36 cases (46.1%) were once misdiagnosed as other disorders.Parasitic encephalopathy is associated with a history of eating raw, with a high rate of misdiagnosis. Internal medicine combined with surgery is an effective way for the therapy.

To investigate the hepatic safety of itraconazole intravenous solution in the treatment of invasive fungal infection.Forty-nine patients with invasive fungal infection, such as pneumonia, meningitis, endocarditis, and blood stream infection, caused by Aspergillus spp. Cryptococcus neoformans, Candida spp. Penicillium marneffei, and Prototheca wickerhamii, 50 of which had underlying diseases, including hepatic diseases, such as hepatitis, cirrhosis, fatty liver etc. were treated with intravenous itraconazole for 12.6 days (2 - 42 days). Liver function test was conducted before and after the treatment. The relationship between liver adverse reaction and itraconazole treatment was evaluated.Liver function test was abnormal in 20 patients. The patients with liver enzyme abnormalities before itraconazole treatment were easier to suffer from hepatic damage during itraconazole treatment (chi(2) = 11.54, P = 0.001). However, only in 2 patients with mild liver function test abnormality the liver adverse reaction could be associated with itraconazole treatment.Itraconazole treatment for invasive fungal infection is rather safe, even in the patients with underlying hepatic diseases. Liver function test is recommended for all patients suggestive of liver dysfunction and protective therapy for liver is needed.

BackgroundThe introduction of pneumococcal conjugate vaccine (PCV) to the U.S. recommended childhood immunization schedule in the year 2000 added three injections to the number of vaccinations a child is expected to receive during the first year of life. Surveys have suggested that the addition of PCV has led some immunization providers to move other routine childhood vaccinations to later ages, which could increase the possibility of missing these vaccines. The purpose of this study was to evaluate whether introduction of PCV affected immunization coverage for recommended childhood vaccinations among 13-month olds in four large provider groups.MethodsIn this retrospective cohort study, we analyzed computerized data on vaccinations for 33,319 children in four large provider groups before and after the introduction of PCV. The primary outcome was whether the child was up to date for all non-PCV recommended vaccinations at 13 months of age. Logistic regression was used to evaluate the association between PCV introduction and the primary outcome. The secondary outcome was the number of days spent underimmunized by 13 months. The association between PCV introduction and the secondary outcome was evaluated using a two-part modelling approach using logistic and negative binomial regression.ResultsOverall, 93% of children were up-to-date at 13 months, and 70% received all non-PCV vaccinations without any delay. Among the entire study population, immunization coverage was maintained or slightly increased from the pre-PCV to post-PCV periods. After multivariate adjustment, children born after PCV entered routine use were less likely to be up-to-date at 13 months in one provider group (Group C: OR = 0.5; 95% CI: 0.3 – 0.8) and were less likely to have received all vaccine doses without any delay in two Groups (Group B: OR = 0.4, 95% CI: 0.3 – 0.6; Group C: OR = 0.5, 95% CI: 0.4 – 0.7). This represented 3% fewer children in Group C who were up-to-date and 14% (Group C) to 16% (Group B) fewer children who spent no time underimmunized at 13 months after PCV entered routine use compared to the pre-PCV baseline. Some disruptions in immunization delivery were also observed concurrent with temporary recommendations to suspend the birth dose of hepatitis B vaccine, preceding the introduction of PCV.ConclusionThese findings suggest that the introduction of PCV did not harm overall immunization coverage rates in populations with good access to primary care. However, we did observe some disruptions in the timely delivery of other vaccines coincident with the introduction of PCV and the suspension of the birth dose of hepatitis B vaccine. This study highlights the need for continued vigilance in coming years as the U.S. introduces new childhood vaccines and policies that may change the timing of existing vaccines.