Increasing the uptake of Intermittent Preventive Treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP) through seasonal malaria chemoprevention channel delivery: protocol of a multicenter cluster randomized implementation trial in Mali and Burkina Faso.

BACKGROUND: The uptake of Intermittent Preventive Treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP) remains unacceptably low, with more than two-thirds of pregnant women in sub-Saharan Africa still not accessing the three or more doses recommended by the World Health Organisation (WHO). In contrast, the coverage of Seasonal Malaria Chemoprevention (SMC), a more recent strategy recommended by the WHO for malaria prevention in children under five years living in Sahelian countries with seasonal transmission, including Mali and Burkina-Faso, is high (up to 90%). We hypothesized that IPTp-SP delivery to pregnant women through SMC alongside antenatal care (ANC) will increase IPTp-SP coverage, boost ANC attendance, and increase public health impact. This protocol describes the approach to assess acceptability, feasibility, effectiveness, and cost-effectiveness of the integrated strategy. METHODS AND ANALYSIS: This is a multicentre, cluster-randomized, implementation trial of IPTp-SP delivery through ANC + SMC vs ANC alone in 40 health facilities and their catchment populations (20 clusters per arm). The intervention will consist of monthly administration of IPTp-SP through four monthly rounds of SMC during the malaria transmission season (July to October), for two consecutive years. Effectiveness of the strategy to increase coverage of three or more doses of IPTp-SP (IPTp3 +) will be assessed using household surveys and ANC exit interviews. Statistical analysis of IPT3 + and four or more ANC uptake will use a generalized linear mixed model. Feasibility and acceptability will be assessed through in-depth interviews and focus group discussions with health workers, pregnant women, and women with a child < 12 months. DISCUSSION: This multicentre cluster randomized implementation trial powered to detect a 45% and 22% increase in IPTp-SP3 + uptake in Mali and Burkina-Faso, respectively, will generate evidence on the feasibility, acceptability, effectiveness, and cost-effectiveness of IPTp-SP delivered through the ANC + SMC channel. The intervention is designed to facilitate scalability and translation into policy by leveraging existing resources, while strengthening local capacities in research, health, and community institutions. Findings will inform the local national malaria control policies. TRIAL REGISTRATION: Retrospectively registered on August 11th, 2022; registration # PACTR202208844472053. Protocol v4.0 dated September 04, 2023. Trail sponsor: University of Sciences Techniques and Technologies of Bamako (USTTB), Mali.

Uptake and determinants of childhood vaccination status among children aged 0-12 months in three West African countries.

BACKGROUND: Vaccination has long been recognized as one of the most effective ways to reduce child mortality. It has played a significant role, particularly for children, and is considered a major achievement and relevant in preventing childhood diseases worldwide. This study looks at the uptake and determinants of childhood vaccination status among children under the age of one year, for Gambia, Sierra Leon, and Liberia. METHOD: Data from 2019 to 20 Demographic and Health Survey (DHS) data from Gambia, Sierra Leone, and Liberia were pooled for the analysis used in this study. Data were obtained from a total weighted sample of 5,368 children aged 0-12 months through a stratified two-stage cluster sampling approach. A multivariable logistic regression model was used to assess the predictors of childhood vaccination uptake at 95% confidence interval (CIs) with computed adjusted odds ratios (aORs). RESULTS: The weighted sample pooled prevalence of full vaccination among children under 12 months of age was 15.1% for males and 15.0% for females. After controlling for confounders in the regression model, factors that were found to be associated with vaccination status include children whose mothers attended postnatal care (PNC) visits had higher odds of being fully vaccinated (aOR = 1.23, 95% CI = 1.03-1.46), while children whose fathers had primary education (aOR = 0.67, 95% CI = 0.48-0.96), children whose households never watched TV (aOR = 0.68, 95% CI = 0.56-0.82) and children whose mothers attended 1-3 antenatal care (ANC) visits (aOR = 0.59, 95% CI = 0.45-0.79) had lower odds of being fully vaccinated. CONCLUSION: Childhood vaccination uptake was low among children under 12 months of age in these countries. Hence, there is a need to promote the uptake of vaccination across these three West African countries especially among rural dwellers.

Durability of SARS-CoV-2-Specific T-Cell Responses at 12 Months Postinfection.

BACKGROUND: Characterizing the longevity and quality of cellular immune responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) enhances understanding of coronavirus disease 2019 (COVID-19) immunity that influences clinical outcomes. Prior studies suggest SARS-CoV-2-specific T cells are present in peripheral blood 10 months after infection. Analysis of the function, durability, and diversity of cellular response long after natural infection, over a range of ages and disease phenotypes, is needed to identify preventative and therapeutic interventions. METHODS: We identified participants in our multisite longitudinal, prospective cohort study 12 months after SARS-CoV-2 infection representing a range of disease severity. We investigated function, phenotypes, and frequency of T cells specific for SARS-CoV-2 using intracellular cytokine staining and spectral flow cytometry, and compared magnitude of SARS-CoV-2-specific antibodies. RESULTS: SARS-CoV-2-specific antibodies and T cells were detected 12 months postinfection. Severe acute illness was associated with higher frequencies of SARS-CoV-2-specific CD4 T cells and antibodies at 12 months. In contrast, polyfunctional and cytotoxic T cells responsive to SARS-CoV-2 were identified in participants over a wide spectrum of disease severity. CONCLUSIONS: SARS-CoV-2 infection induces polyfunctional memory T cells detectable at 12 months postinfection, with higher frequency noted in those who experienced severe disease.

Egg OIT in clinical practice (SEICAP II): Maintenance patterns and desensitization state after normalizing the diet.

BACKGROUND: It is unknown which are the most suitable maintenance pattern and egg consumption to maintain the desensitization state after ending the oral immunotherapy (OIT). This multicenter, randomized, controlled trial compared two OIT maintenance patterns with pasteurized egg white (PEW), evaluating the egg consumption effect on the desensitization state after ending the OIT. METHODS: One hundred and one children with confirmed egg allergy were randomized: 25 to an egg-free diet (CG) and 76 to an OIT year with PEW and two maintenance patterns, 38 patients to daily 3.3 g proteins (AG) and 38 to every two days (BG). PEW challenge (DBPCFC), adverse reactions, and immune markers were assessed at baseline, at the end of the OIT, and at 6 and 12 months later on ad libitum egg consumption (T0, T12, T18, and T24). A questionnaire evaluated the egg consumption at T18. RESULTS: At T12, 64 of 76 (84.21%) OIT patients had reached total desensitization (32 AG and 32 BG) vs 4 of 25 (16.00%) CG who passed the PEW DBPCFC. Thirty (93.75%) AG vs 25 (78.12%) BG patients completed an OIT year. At T18, 27 of 29 (93.1%) AG vs 20 of 24 (83.3%) BG passed the PEW DBPCFC, 96% consuming at least two egg servings/week. At T24, 97.43% OIT patients passed the challenge. Most patients had adverse reactions, more frequent in the BG patients; frequency and severity of reactions decreased through the study. PEW skin prick test wheal and sIgE antibody serum levels similarly decreased in AG or BG, but AG patients had greater increase in PEW sIgG4 (P < 0.05). CONCLUSIONS: Daily OIT maintenance achieves better adherence, effectiveness, and safety. Two egg servings/week ensure maintained desensitization after the end of an OIT year.

Pentaerythrityl tetranitrate improves the outcome of children born to mothers with compromised uterine perfusion-12-months follow-up and safety data of the double-blind randomized PETN trial.

BACKGROUND: This is a follow-up study to the pentaerythrityl tetranitrate randomized controlled multicenter trial that reports neonatal outcome data of newborns admitted to neonatal intensive care units and outcome data of the offspring at 12 months of age. OBJECTIVE: We present data on adverse events reported during the study to document the safety of pentaerythrityl tetranitrate treatment during pregnancy. To further evaluate the effects of pentaerythrityl tetranitrate on neonatal and long-term outcomes, we present follow up data from of 240 children at 12 months of age, including information on height, weight, head circumference, developmental milestones, and the presence of chronic disease and of 144 newborns admitted to the neonatal intensive care unit during the trial. STUDY DESIGN: The pentaerythrityl tetranitrate trial was a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of the nitric oxide-donor pentaerythrityl tetranitrate in the prevention of fetal growth restriction and perinatal death in pregnancies complicated by abnormal placental perfusion. RESULTS: Results at 12 months demonstrated that significantly more children were age appropriately developed without impairments in the pentaerythrityl tetranitrate group (P=.018). In addition, the presence of chronic disease was lower in the pentaerythrityl tetranitrate group (P=.041). Outcome data of the 144 newborns admitted to the neonatal intensive care unit did not reveal differences between the treatment and placebo groups. There were no differences in the number or nature of reported adverse events between the study groups. CONCLUSION: The analysis shows that study children born in the pentaerythrityl tetranitrate cohort have a clear advantage compared with the placebo group at the age of 12 months, as evidenced by the increased incidence of normal development without the presence of chronic disease. Although safety has been proven, further follow-up studies are necessary to justify pentaerythrityl tetranitrate treatment during pregnancies complicated by impaired uterine perfusion.

Edinburgh Postnatal Depression Scale (EPDS) for screening for depression in the first year post delivery in a low-resourced rural setting in Kenya.

Postnatal depression is one of the most common mental disorders among postnatal mothers and may have severe consequences for mothers and their children. Locally validated screening tools that can be self- or lay interviewer-administered are required to identify at-risk women, especially in settings with no mental health specialists. This study aimed to assess the validity and reliability of a culturally adapted version of the Edinburgh Postnatal Depression Scale (EPDS) in a local dialect (Kamba) in a Kenyan setting. Trained research assistants administered the local-language version of self-report scales (EPDS) to a sample of 544 Kamba-speaking women. The same scale was re-administered to the same research participants two weeks later by the same research assistants. The test scores were compared with an external 'gold standard' according to the DSM-IV criteria Mini-International Neuropsychiatric Interview for adults (MINI-Plus). The EPDS had an area under the curve (AUC) of 0.867 with 95% C.I of 0.836 to 0.894, with a cut-off point of ≥11, sensitivity of 81.0% (95% C.I 70.6-89.0) and specificity of 82.6% (95% CI 78.8-85.9). The positive predictive value (PPV) and negative predictive value (NPV) were 44.1% and 96.2%, respectively. The internal reliability was 0.852 and the test-retest reliability was 0.496. The EPDS showed good utility in detecting depressive disorder in Kamba-speaking postnatal women. It does not have to be administered by mental health workers (who are few in low- and middle-income countries); rather, this can be done by a trained lay interviewer.

Safety of Cochlear Implantation in Children 12 Months or Younger: Systematic Review and Meta-analysis.

OBJECTIVE: To systematically review the literature to determine safety of cochlear implantation in pediatric patients 12 months and younger. DATA SOURCE: Ovid MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched from inception to March 20, 2021. REVIEW METHODS: Studies that involved patients 12 months and younger with report of intraoperative or postoperative complication outcomes were included. Studies selected were reviewed for complications, explants, readmissions, and prolonged hospitalizations. Two independent reviewers screened all studies that were selected for the systematic review and meta-analysis. All studies included were assessed for quality and risk of bias. RESULTS: The literature search yielded 269 studies, of which 53 studies underwent full-text screening, and 18 studies were selected for the systematic review and meta-analysis. A total of 449 patients and 625 cochlear implants were assessed. Across all included studies, major complications were noted in 3.1% of patients (95% CI, 0.8-7.1) and 2.3% of cochlear implantations (95% CI, 0.6-5.2), whereas minor complications were noted in 2.4% of patients (95% CI, 0.4-6.0) and 1.8% of cochlear implantations (95% CI, 0.4-4.3). There were no anesthetic complications reported across all included studies. CONCLUSION: The results of this systematic review and meta-analysis suggest that cochlear implantation in patients 12 months and younger is safe with similar rates of complications to older cohorts.

Analysis of Factors Affecting the Third- and Twelfth-Month Mortality in Patients with Hip Fractures Aged 80 Years and Older.

Background: The purpose of this study was to evaluate the possible risk factors that are related with mortality at third and twelfth months after hip fractures in a large population of patients aged 80 years and older. Methods: 605 patients were evaluated in terms of the localization of the fracture, gender, age, side of the fracture, the type of applied procedure, anesthesia type, hospitalization time, time to operation, comorbidities, ASA score, the values of preoperative hemoglobin, lymphocyte and neutrophil percentage, white blood cell, albumin, sodium levels. The state mortality system was used to investigate whether patients are alive or died. Statistical analysis was performed to evaluate the important factors on third- and twelfth-month mortality. Results: Male gender, neurologic-cardiac-chronic obstructive pulmonary (COP) diseases, preoperative hemoglobin level < 10 g/dL, arthroplasty and external fixator groups, ASA grade ≥ 3, delaying the surgery more than 4 days, longer hospitalization time, lower albumin levels and advanced age were found to be statistically significant factors for 3-month mortality (p values were; 0.01, 0.02, 0.01, 0.01, 0.047, 0.01, 0.02, 0.002, < 0.001, 0.002 and 0.01, respectively). Male gender, hypertension-neurologic-cardiac diseases, preoperative hemoglobin level < 10 g/dL, delaying the surgery more than 4 days, longer hospitalization time, lower lymphocyte percentage, lower albumin levels and advanced age were found to be statistically significant factors for 12-month mortality (p values were; < 0.001, 0.01, 0.01, 0.01, 0.03, 0.01, < 0.001, 0.01, 0.004 and < 0.001, respectively). Conclusion: COP, advanced age, and heart disease were the most important factors in 3-month mortality. Long hospitalization time, male gender and advanced age were the most important factors affecting the 12-month mortality.Level of Evidence Prognostic level IV.

Prevalence and pattern of work-related musculoskeletal disorders among Nigerian bricklayers.

BACKGROUND: Typically, bricklayers in developing countries' contexts manually lay bricks, concrete blocks and other similar materials to construct walls and buildings which make them susceptible to work-related musculoskeletal disorders (WRMSDs). The burden of WRMSDs among this high-risk group seems has not been well documented. OBJECTIVES: This study examined the prevalence of WRMSDs among bricklayers in Nigeria. METHODS: A cross-sectional survey of 118 consenting bricklayers from a Nigerian setting was carried out. The standardized Nordic musculoskeletal disorder questionnaire and a proforma were used to profile the prevalence of WRMSDs and socio-demographic information of the respondents. Data was analyzed using descriptive and inferential statistics. Alpha level was set at p < 0.05. RESULTS: The 12-months and 7-days prevalence of WRMSDs were 87.3% and 67.4%. Shoulder (61.0%) and the low-back (59.3%) were the two most affected anatomical sites based on 12-month prevalence. WRMSDs affecting the knees (6.8%) was the most disabling in carrying normal work routines. Working for less than 10 years was significantly associated with high prevalence of WRMSDs in the shoulder (odd ratio (OR) = 0.27, 95% confidence interval (CI) = 0.09 to 0.87) and wrist region (OR = 0.24, 95% CI 0.08 to 0.73). Having neck pain led to higher odds (OR = 0.29, 95% CI 0.13 to 0.68) of taking a break from work among the bricklayers. CONCLUSIONS: WRMSDs were high among Nigerian bricklayers. Years of work experience was associated with high prevalence of WRMSDs in the shoulder and wrist. In addition, taking work breaks was associated with neck pain.

The prevalence of diseases in German emergency medical services staff: A survey study.

For the general German population, the GEDA study is the main health monitoring study. Since nothing comparable is existing regarding the health of emergency medical services (EMS) staff, the aim of the present study was to estimate the 12-months prevalence of socially relevant diseases and symptoms among German pre-hospital EMS staff. This was a nationwide survey study. For retrieval of information on the health status of participating EMS staff items from the GEDA2014/2015 study were used. Afterwards, 12-months prevalence or proportions and corresponding 95% confidence intervals (95% CI) were calculated. Overall, 2,313 German pre-hospital EMS staff (42.6% female/57.2% male) with a median age of 25.0 (min. 18.0; max. 63.0) years were included into the final analysis. Obesity based on BMI was present in 25.9% (95% CI: 23.5%; 28.4%) of male compared to 15.7% (95% CI: 13.5%; 18.1%) of female study participants. Highest 12-months prevalence in the full study sample were calculated for lower back pain (41.1% [95%: 39.1%; 43.2%]), cervical pain (32.9% [95% CI: 30.9%; 34.8%]), allergies (32.6% [95% CI: 30.7%; 34.6%], depression (13.7% [95% CI: 12.4%; 15.2%]), and hypertension (11.5% [95% CI: 10.3%; 12.9%]). The 12-months prevalence in specific age-/gender-groups were higher for asthma, depression, hypertension, increased blood lipids, and osteoarthritis among study participants compared to the general German population (GEDA study) with the same age and gender (ratio ≥ 1.5). This study indicates that the prevalence of obesity, depression, hypertension, and other disorders is high among study participants and disease prevention measures for pre-hospital EMS staff are needed.

Status of Humoral and Cellular Immune Responses within 12 Months following CoronaVac Vaccination against COVID-19.

Understanding immune memory to COVID-19 vaccines is critical for the design and optimal vaccination schedule for curbing the COVID-19 pandemic. Here, we assessed the status of humoral and cellular immune responses at 1, 3, 6, and 12 months after two-dose CoronaVac vaccination. A total of 150 participants were enrolled, and 136 of them completed the study through the 12-month endpoint. Our results show that, at 1 month after vaccination, both binding and neutralizing antibodies could be detected; the seropositive rate of binding antibodies and seroconversion rate of neutralizing antibodies were 99% and 50%, respectively. From 3 to 12 months, the binding and neutralizing antibodies declined over time. At 12 months, the binding and neutralizing antibodies were still detectable and significantly higher than the baseline. Gamma interferon (IFN-γ) and interleukin 2 (IL-2) secretion specifically induced by the receptor-binding domain (RBD) persisted at high levels until 6 months and could be observed at 12 months, while the levels of IL-5 and granzyme B (GzmB) were hardly detected, demonstrating a Th1-biased response. In addition, specific CD4+ T central memory (TCM), CD4+ effector memory (TEM), CD8+ TEM, and CD8+ terminal effector (TE) cells were all detectable and functional up to 12 months after the second dose, as the cells produced IFN-γ, IL-2, and GzmB in response to stimulation of SARS-CoV-2 RBD. Our work provides evidence that CoronaVac induced not only detectable binding and neutralizing antibody responses, but also functional SARS-CoV-2-specific CD4+ and CD8+ memory T cells for up to 12 months. IMPORTANCE CoronaVac is an inactivated vaccine containing whole-virion SARS-CoV-2, which has been approved in 43 countries for emergency use as of 26 November 2021. However, the long-term immune persistence of the CoronaVac vaccine is still unknown. Here, we reported the status of the persistence of antibodies and cellular responses within 12 months after two doses of CoronaVac. Such data are crucial to inform ongoing and future vaccination strategies to combat COVID-19.

Twelve-Month Longitudinal Serology in SARS-CoV-2 Naïve and Experienced Vaccine Recipients and Unvaccinated COVID-19-Infected Individuals.

Longitudinal data comparing SARS-CoV-2 serology in individuals following infection and vaccination over 12 months are limited. This study compared the magnitude, decay, and variability in serum IgG, IgA, and neutralizing activity induced by natural infection (n = 218) or mRNA vaccination in SARS-CoV-2 naïve (n = 143) or experienced (n = 122) individuals over time using enzyme-linked immunosorbent assays and an in vitro virus neutralization assay. Serological responses were found to be highly variable after natural infection compared with vaccination but durable through 12 months. Antibody levels in vaccinated, SARS-CoV-2 naïve individuals peaked by 1 month then declined through 9 months, culminating in non-detectable SARS-CoV-2-specific serum IgA. Individuals with both infection and vaccination showed SARS-CoV-2-specific IgG and IgA levels that were more robust and slower to decline than the other groups; neutralizing activity remained highest in this group at 9 months past vaccination. These data reinforce the benefit of vaccination after SARS-CoV-2 recovery.

Maintenance of broad neutralizing antibodies and memory B cells 1 year post-infection is predicted by SARS-CoV-2-specific CD4+ T cell responses.

Understanding the long-term maintenance of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunity is critical for predicting protection against reinfection. In an age- and gender-matched cohort of 24 participants, the association of disease severity and early immune responses on the maintenance of humoral immunity 12 months post-infection is examined. All severely affected participants maintain a stable subset of SARS-CoV-2 receptor-binding domain (RBD)-specific memory B cells (MBCs) and good neutralizing antibody breadth against the majority of the variants of concern, including the Delta variant. Modeling these immune responses against vaccine efficacy data indicate a 45%-76% protection against symptomatic infection (variant dependent). Overall, these findings indicate durable humoral responses in most participants after infection, reasonable protection against reinfection, and implicate baseline antigen-specific CD4+ T cell responses as a predictor of maintenance of antibody neutralization breadth and RBD-specific MBC levels at 12 months post-infection.

Role of ductular reaction and ductular-canalicular junctions in identifying severe primary biliary cholangitis.

Background & Aims: Primary biliary cholangitis (PBC) is a chronic cholangiopathy characterised by immuno-mediated injury of interlobular bile ducts leading to intrahepatic cholestasis and progressive liver fibrosis. PBC histology is characterised by portal inflammation, progressive fibrosis, ductopenia, and the appearance of the so-called ductular reaction. The aim of the present study was to investigate the pathogenetic relevance of ductular reaction in PBC. Methods: Liver biopsies were collected from naïve people with PBC (N = 87). Clinical-serological parameters were obtained at diagnosis and after 1 year of ursodeoxycholic acid (UDCA) treatment. Histological staging was performed on all slides according to multiple scoring systems and criteria for PBC. Liver samples were obtained from Mdr2 -/- mice treated with or without UDCA. Samples were processed for histology, immunohistochemistry, and immunofluorescence. Results: Ductular reaction in people with PBC correlated with the disease stage and liver fibrosis, but not with disease activity; an extensive ductular reaction correlated with serum alkaline phosphatase levels at diagnosis, response to UDCA, and individuals' estimated survival, independently from other histological parameters, including disease stage. In people with PBC, reactive ductules were associated with the establishment of junctions with bile canaliculi and with fibrogenetic cell activation. Consistently, in a mouse model of intrahepatic cholestasis, UDCA treatment was effective in reducing ductular reaction and fibrosis and increasing ductular-canalicular junctions. Conclusions: Extensive ductular reaction outlines a severe histologic phenotype in PBC and is associated with an inadequate therapy response and a worse estimated prognosis. Lay summary: In people affected by primary biliary cholangitis (PBC), the histological appearance of extensive ductular reaction identifies individuals at risk of progressive fibrosis. Ductular reaction at diagnosis correlates with the lack of response to first-line therapy with ursodeoxycholic acid and serves to restore ductular-canalicular junctions in people with PBC. Assessing ductular reaction extension at diagnosis may add valuable information for clinicians.

Influence of postnatal polycyclic aromatic hydrocarbon exposure on the neurodevelopment of toddlers at the age of 12 months.

OBJECTIVES: To investigate the possible influence of polycyclic aromatic hydrocarbons (PAHs) exposure on neurodevelopment of toddlers at the age of 12 months. METHODS: Totally 306 subjects were recruited from the Qingdao Birth Cohort established in 2014. PAH-DNA adducts in toddlers' umbilical cord blood samples, hydroxyl-PAH metabolites in their urine samples and the developmental quotients (DQs) were measured. Sex, gestational age, birth weight, and maternal educational background were adjusted to analyze the influence of the PAH exposure on the neurodevelopment of the toddlers using multivariate linear regression model. RESULTS: Pearson correlation test showed that the logarithmic values of hydroxyl-PAH were negatively correlated with the DQs. Multivariate linear regression analysis indicated that logarithmic concentration of 1(9)- hydroxyphenanthrene was still associated with the DQs of the fine motor behaviors with ß and 95% confidential interval (CI) of -1.137 (-2.053, -0.222), together with PAH-DNA adducts [ß (95% CI): -0.577 (-0.930, -0.225)]. PAH-DNA adducts presented an independently negative influence on the DQs of the gross motor and personal social behaviors with ß (95%CI) of -0.470 (-0.814, -0.126) and -0.526 (-0.859, -0.193), respectively. CONCLUSIONS: The exposure to PAHs in toddlers at 12 months could influence their neurodevelopment. Additionally, prenatal exposure to PAHs should also be considered.

Type of Milk Feeding and Introduction to Complementary Foods in Relation to Infant Sleep: A Systematic Review.

Inconsistent conclusions from infant sleep and feeding studies may influence parents feeding-related decisions. This study aimed to systematically review the existing literature on infant sleep and its relation to the timing of introduction to complementary foods and type of milk feeding to better understand their role(s) in infant sleep. Cohort, longitudinal, cross-sectional studies, and controlled trials were identified using online searches of five databases up to April 2020. Twenty-one articles with a total of 6225 infants under 12 months-of-age were eligible. Exclusively breastfed infants (≤6 months-of-age) had a greater number of night wakings, but most studies (67%) reported no difference in night-time and 24 h sleep duration compared to formula-fed infants. However, after 6 months-of-age, most studies (>65%) reported breastfed infants to sleep less in the night-time and over 24 h compared to formula-fed infants. Furthermore, studies reported no association between the timing of introduction to complementary foods and infant sleep duration (<12 months-of-age). Future studies using standardized methodologies and definitions, transdisciplinary expertise, and longitudinal design are required to better understand the complex role of feeding on sleep.

Early Axonal Dysfunction of the Peripheral Nervous System Influences Disease Progression of ALS: Evidence From Clinical Neuroelectrophysiology.

Objective: To assess the prognostic value of the decrement in compound muscle action potential amplitude within 12 months of symptom onset (CMAP-12 amplitude) for the survival of patients with amyotrophic lateral sclerosis (ALS). Methods: Patients were stratified into 4 groups according to the decrement of the CMAP-12 amplitudes: normal (≥the lower limit of normal, LLN), mild (

One-year Oxford knee scores should be used in preference to 6-month scores when assessing the outcome of total knee arthroplasty.

PURPOSE: The primary aim of this study was to assess whether there was a clinically significant difference in the mean Oxford knee score (OKS) between 6 and 12 months after total knee arthroplasty (TKA). The secondary aim was to identify variables associated with a clinically significant change in the OKS between 6 and 12 months. METHODS: A retrospective cohort study was undertaken using an established arthroplasty database of 1574 primary TKA procedures. Patient demographics, body mass index (BMI), comorbidities, OKS and EuroQoL 5-domain (EQ-5D) score were collected preoperatively and at 6 and 12 months postoperatively. A clinically significant change in the OKS was defined as 5 points or more. RESULTS: There was a 1.1-point increase in the OKS between 6 and 12 months postoperatively, which was statistically significant (95% confidence (CI) 0.8-1.3, p < 0.0001). There were 381 (24.2%) patients who had a clinically significant improvement in their OKS from 6 to 12 months. After adjusting for confounding, patients with a lower BMI (p = 0.028), without diabetes mellitus (p < 0.001), a better preoperative OKS (p < 0.001) or a worse 6-month OKS (p < 0.001) were more likely to have a clinically significant improvement. A 6-month OKS < 36 points was a reliable predictor of a clinically significant improvement in the 6-month to 12-month OKS (area under the curve 0.73, 95% CI 0.70-0.75, p < 0.001). CONCLUSION: Overall, there was no clinically significant change in the OKS from 6 to 12 months; however, a clinically significant improvement was observed in approximately a quarter of patients and was more likely in those scoring less than 36 points at 6 months. LEVEL OF EVIDENCE: retrospective diagnostic study, level III.

Maintenance of treatment gains up to 12-months following a three-week cognitive processing therapy-based intensive PTSD treatment programme for veterans.

BACKGROUND: Intensive treatment programmes (ITPs) have shown promise for reducing PTSD and depression symptoms. It is still unknown whether treatment gains are maintained following completion. OBJECTIVE: This study examined whether veterans were able to maintain treatment gains for up to 12 months after an ITP for PTSD and whether reductions in negative posttrauma cognitions predicted treatment gain maintenance. METHODS: 209 veterans (62.7% male, mean age = 40.86 years) completed a 3-week, CPT-based ITP for PTSD. Participants' PTSD (PCL-5) and depression (PHQ-9) symptoms were assessed at pre-treatment, post-treatment, and at 3-, 6-, and 12-month follow-up timepoints. RESULTS: Despite small symptom increases from post-treatment to 3-month follow-up, significant and clinically meaningful reductions in PTSD and depression symptoms were reported from intake to 12 months follow-up (averaging >18 points on the PCL-5 and >6 points on the PHQ-9; d = 1.28, and d = 1.18, respectively). Greater reductions in negative posttrauma cognitions during treatment were associated with lower PTSD (p <.001) and depression (p =.005) severity at follow-up. Most veterans who completed the aftercare survey followed treatment recommendations and reported seeing a mental health provider at 3-, 6-, and 12-months post-treatment. Aftercare treatment did not significantly predict whether veterans maintained treatment gains at follow-up. CONCLUSIONS: Overall maintenance of treatment gains long-term suggests veterans may be able to apply skills acquired during the ITP following treatment. These findings further support the feasibility and effectiveness of intensive, trauma-focused, evidence-based therapy delivery.

Antecedentes: Los programas de tratamiento intensivos (ITPs por sus siglas en inglés) han mostrado ser promisorios para reducir el TEPT y los síntomas depresivos. Se desconoce aún si las ganancias del tratamiento se mantienen después de la finalización. Este estudio examinó si los veteranos fueron capaces de mantener las ganancias del tratamiento después de 12 meses de un ITP para TEPT y si las reducciones de las cogniciones negativas postrauma predijeron la mantención de las ganancias del tratamiento.Método: 209 veteranos (62,7% varones, edad media=40,86 años) completaron una ITP de 3 semana basado en CPT. Los síntomas de TEPT (PCL-5) y depresión (PHQ-9) de los participantes se evaluaron pre-tratamiento,post tratamiento y a los 3,6 y 12 meses de seguimiento.Resultados: A pesar de un pequeño aumento de los síntomas a los tres meses de seguimiento después de terminado el tratamiento, se reportaron reducciones clínicamente significativas e importantes en el TEPT y síntomas depresivos desde el inicio hasta los 12 meses de seguimiento (un promedio ˃18 puntos en el PCL-5 y ˃6 puntos en el PHQ-9; d=1.28, y d=1.18, respectivamente. Las mayores reducciones en las cogniciones negativas postrauma durante el tratamiento se asociaron con una menor severidad del TEPT (p˂ .001) y depresión (p=.005) en el seguimiento. La mayoría de los veteranos que completaron la encuesta de cuidados posteriores siguieron las recomendaciones del tratamiento e informaron haber visto a algún profesional de salud mental a los 3, 6 y 12 meses post-tratamiento. Los cuidados posteriores al tratamiento no predijeron significativamente si los veteranos mantenían las ganancias del tratamiento en el seguimiento.Conclusiones: el mantenimiento general de las ganancias del tratamiento a largo plazo sugiere que los veteranos pueden aplicar las habilidades adquiridas durante la PTI después del tratamiento.Estos hallazgos respaldan aún más la viabilidad y efectividad de la administración en forma intensiva de una terapia basada en la evidencia y centrada en el trauma.

Somatic Experiencing® for patients with low back pain and comorbid posttraumatic stress symptoms - a randomised controlled trial.

BACKGROUND: Low back pain (LBP) and comorbid post-traumatic stress symptoms (PTSS) are common after traumatic injuries, and a high level of PTSS is associated with more severe pain and pain-related disability. Few randomised controlled trials (RCT) exist targeting comorbid PTSS and chronic pain, and only one has assessed the effect of Somatic Experiencing®. OBJECTIVE: The aim of this study was to assess the effect of Somatic Experiencing® (up to 12 sessions) + physiotherapeutic intervention (4-8 sessions) (SE+PT) compared with the physiotherapeutic intervention alone (4-8 sessions) (PT) for pain-related disability in LBP with comorbid PTSS. METHODS: The study was a two-group RCT in which participants (n = 114) were recruited consecutively from a large Danish Spine Centre. Patients were randomly allocated to either SE+PT or PT alone. Outcomes were collected at baseline before randomisation, 6 and 12-month post-randomisation. The primary outcome was pain-related disability as measured with the modified version of the Roland Morris Disability Questionnaire at 6-month post-randomisation. Secondary outcomes were PTSS, pain intensity, pain-catastrophising, kinesiophobia, anxiety and depression. RESULTS: No significant group differences were found on any of the outcomes at any timepoints. Both groups achieved a significant reduction in pain-related disability (20-27%) as measured by the Roland Morris Disability Questionnaire at 6 and 12-month follow up. Also, both groups achieved a small reduction in PTSS. CONCLUSIONS: Although significant effects were achieved for both groups, the additional SE intervention did not result in any additional benefits in any of the outcomes.

Antecedentes: La lumbalgia y los síntomas comórbidos de estrés postraumático (SCET) son comunes luego de lesiones traumáticas, y un alto nivel de los SCET está asociado con dolor más severo y con discapacidad asociada al dolor. Existen escasos ensayos clínicos aleatorizados enfocados en los SCET y en dolor crónico, y solo uno ha evaluado el efecto de la Experiencia Somática®.Objetivo: El objetivo de este estudio fue el de evaluar el efecto de la Experiencia Somática® (hasta un máximo de 12 sesiones) adicionada a la intervención fisioterapéutica (entre 4 a 8 sesiones) (ES+IF), comparada con la intervención fisioterapéutica sola (entre 4 a 8 sesiones) (IF), sobre la discapacidad asociada al dolor en lumbalgia con SCET.Métodos: El estudio consistió en un ensayo clínico aleatorizado de dos grupos para el que se reclutó a participantes (n=144) consecutivamente de un gran Centro Danés de Columna Vertebral. Los pacientes fueron distribuidos aleatoriamente al grupo de ES+IF o al grupo de solo IF. Los puntos de corte se realizaron de base antes de la aleatorización, y a los 6 y 12 meses luego de la aleatorización. El resultado principal era la discapacidad asociada a dolor, medida mediante la versión modificada del Cuestionario de Discapacidad de Roland Morris a los seis meses luego de la aleatorización. Los resultados secundarios fueron los SCET, la intensidad del dolor, la catastrofización sobre el dolor, la quinesofobia, la ansiedad, y la depresión.Resultados: No se encontraron diferencias significativas entre los grupos sobre los resultados medidos, en ningún punto de corte. Ambos grupos alcanzaron una reducción significativa de la discapacidad asociada a dolor (20 ­ 27%), medida mediante el Cuestionario de Discapacidad de Roland Morris a los 6 y a los 12 meses. Además, ambos grupos alcanzaron una reducción pequeña en los SCET.Conclusiones: A pesar de que se alcanzaron resultados significativos en ambos grupos, la intervención adicional mediante Experiencia Somática® no aportó ningún beneficio adicional sobre ninguno de los resultados.