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Nevin Manimala Statistics

Heterogeneity of outcome measures in depression trials and the relevance of the content of outcome measures to patients: a systematic review

Lancet Psychiatry. 2024 Apr;11(4):285-294. doi: 10.1016/S2215-0366(23)00438-8.

ABSTRACT

Research waste occurs when randomised controlled trial (RCT) outcomes are heterogeneous or overlook domains that matter to patients (eg, relating to symptoms or functions). In this systematic review, we reviewed the outcome measures used in 450 RCTs of adult unipolar and bipolar depression registered between 2018 and 2022 and identified 388 different measures. 40% of the RCTs used the same measure (Hamilton Depression Rating Scale [HAMD]). Patients and clinicians matched each item within the 25 most frequently used measures with 80 previously identified domains of depression that matter to patients. Seven (9%) domains were not covered by the 25 most frequently used outcome measures (eg, mental pain and irritability). The HAMD covered a maximum of 47 (59%) of the 80 domains that matter to patients. An interim solution to facilitate evidence synthesis before a core outcome set is developed would be to use the most common measures and choose complementary scales to optimise domain coverage. TRANSLATIONS: For the French and Dutch translations of the abstract see Supplementary Materials section.

PMID:38490761 | DOI:10.1016/S2215-0366(23)00438-8

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Nevin Manimala Statistics

Characteristics and phenotypes of a COPD cohort from referral hospital clinics in Uganda

BMJ Open Respir Res. 2024 Mar 15;11(1):e001816. doi: 10.1136/bmjresp-2023-001816.

ABSTRACT

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is a heterogeneous condition with varied clinical and pathophysiological characteristics. Although there is increasing evidence that COPD in low-income and middle-income countries may have different clinical characteristics from that in high-income countries, little is known about COPD phenotypes in these settings. We describe the clinical characteristics and risk factor profile of a COPD population in Uganda.

METHODS: We cross sectionally analysed the baseline clinical characteristics of 323 patients with COPD aged 30 years and above who were attending 2 national referral outpatient facilities in Kampala, Uganda between July 2019 and March 2021. Logistic regression was used to determine factors associated with spirometric disease severity.

RESULTS: The median age was 62 years; 51.1% females; 93.5% scored COPD Assessment Test >10; 63.8% modified medical research council (mMRC) >2; 71.8% had wheezing; 16.7% HIV positive; 20.4% had a history of pulmonary tuberculosis (TB); 50% with blood eosinophilic count >3%, 51.7% had 3 or more exacerbations in the past year. Greater severity by Global initiative for Chronic Obstructive Lung Disease (GOLD) stage was inversely related to age (aOR=0.95, 95% CI 0.92 to 0.97), and obesity compared with underweight (aOR=0.25, 95% CI 0.07 to 0.82). Regarding clinical factors, more severe airflow obstruction was associated with SPO2 <93% (aOR=3.79, 95% CI 2.05 to 7.00), mMRC ≥2 (aOR=2.21, 95% CI 1.08 to 4.53), and a history of severe exacerbations (aOR=2.64, 95% CI 1.32 to 5.26).

CONCLUSION: Patients with COPD in this population had specific characteristics and risk factor profiles including HIV and TB meriting tailored preventative approaches. Further studies are needed to better understand the pathophysiological mechanisms at play and the therapeutic implications of these findings.

PMID:38490695 | DOI:10.1136/bmjresp-2023-001816

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Nevin Manimala Statistics

Global relevance of MGRS growth standards: the case of India

BMJ Paediatr Open. 2024 Mar 15;8(1):e002472. doi: 10.1136/bmjpo-2023-002472.

ABSTRACT

The most common measures of childhood undernutrition are based on anthropometric measures such as height-for-age (stunting/chronic undernutrition) and weight-for-height (wasting/acute undernutrition). It is well recognised that the determinants of undernutrition are multiple, including food intake, dietary diversity, health, sanitation and women’s status. Currently, most countries across the world including India use the globally accepted WHO-Multicentre Growth Reference Study (MGRS) growth standards (2006) for the purposes of measurement as well as for evaluating progress on these metrics. However, there is some discussion on the universal relevance of these standards, and in the Indian context, whether these standards overestimate the prevalence of stunting, considering differences in genetic potential for growth. This is especially relevant in the context of increasing burden of obesity and non-communicable diseases in India. Based on a detailed review of literature, policy documents and expert inputs, this review paper discusses the relevance of the WHO growth standards for height/stunting, in the context of India. Issues discussed related to the MGRS methodology include pooling of data and intersite and intrasite variability, opting for standards as opposed to references, and external validity. Other issues related to plasticity of stunting and the influence of maternal heights are also discussed, in the context of analysing the appropriateness of using universal growth standards. Based on the review, it is recommended that the current standards may continue to be used until a newer global standard is established through a similar study.

PMID:38490693 | DOI:10.1136/bmjpo-2023-002472

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Psychological burden associated with incident persistent symptoms and their evolution during the COVID-19 pandemic: a prospective population-based study

BMJ Ment Health. 2024 Mar 15;27(1):e300907. doi: 10.1136/bmjment-2023-300907.

ABSTRACT

BACKGROUND: Identifying factors that predict the course of persistent symptoms that occurred during the COVID-19 pandemic is a public health issue. Modifiable factors could be targeted in therapeutic interventions.

OBJECTIVE: This prospective study based on the population-based CONSTANCES cohort examined whether the psychological burden associated with incident persistent symptoms (ie, that first occurred from March 2020) would predict having ≥1 persistent symptom 6-10 months later.

METHODS: A total of 8424 participants (mean age=54.6 years (SD=12.6), 57.2% women) having ≥1 incident persistent symptom at baseline (ie, between December 2020 and February 2021) were included. The psychological burden associated with these persistent symptoms was assessed with the Somatic Symptom Disorder-B Criteria Scale (SSD-12). The outcome was having ≥1 persistent symptom at follow-up. Adjusted binary logistic regression models examined the association between the SSD-12 score and the outcome.

FINDINGS: At follow-up, 1124 participants (13.3%) still had ≥1 persistent symptom. The SSD-12 score at baseline was associated with persistent symptoms at follow-up in both participants with (OR (95% CI) for one IQR increase: 1.42 (1.09 to 1.84)) and without SARS-CoV-2 infection prior to baseline (1.39 (1.25 to 1.55)). Female gender, older age, poorer self-rated health and infection prior to baseline were also associated with persistent symptoms at follow-up.

CONCLUSIONS: The psychological burden associated with persistent symptoms at baseline predicted the presence of ≥1 persistent symptom at follow-up regardless of infection prior to baseline.

CLINICAL IMPLICATIONS: Intervention studies should test whether reducing the psychological burden associated with persistent symptoms could improve the course of these symptoms.

PMID:38490690 | DOI:10.1136/bmjment-2023-300907

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Scoping review of smoking cessation interventions in pregnant women attending primary care

BJGP Open. 2024 Mar 15:BJGPO.2023.0185. doi: 10.3399/BJGPO.2023.0185. Online ahead of print.

ABSTRACT

BACKGROUND: Smoking during pregnancy has many adverse effects for infant and mother. Despite this, many pregnant women continue smoking. Primary care is a suitable area to provide smoking cessation interventions.

AIM: To investigate available literature regarding effectiveness of smoking cessation interventions for pregnant women in primary care, the factors contributing to this effectiveness and to provide suggestions for future research.

DESIGN & SETTING: Systematic scoping literature review.

METHOD: The methodology followed PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) extension for scoping reviews. Five electronic databases were searched. Inclusion criteria included original research studies and studies published in English. Data were extracted using a modified Johanna Briggs Institute data charting tool.

RESULTS: The initial search yielded 878 articles. Following article screening, twelve studies were included. Five studies found a statistically significant increase in smoking cessation rates or reduction in tobacco consumed in the intervention group. The remaining studies showed no significant difference between the groups. However, ten studies showed the control group received usual antenatal care involving smoking cessation promotion. An increase in smoking cessation rates was seen in intervention and control groups, demonstrating the effectiveness of these interventions. Interventions included education, counselling, self-help and financial incentives. They were delivered by general practitioners, midwives, counsellors and pregnancy advisors.

CONCLUSION: Primary care is suitable to offer smoking cessation interventions to pregnant women, as it is often the first point of care and more easily accessible than secondary care. Future research is needed to determine the most effective types of interventions.

PMID:38490678 | DOI:10.3399/BJGPO.2023.0185

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Prevalence and predictors of depression and anxiety in patients with chronic rhinosinusitis: a systematic review and meta-analysis

BMJ Open. 2024 Mar 15;14(3):e079273. doi: 10.1136/bmjopen-2023-079273.

ABSTRACT

BACKGROUND: Chronic rhinosinusitis (CRS) is a persistent inflammation of the sinuses. As a result of long-term discomfort, patients may experience symptoms of common mental disorders such as anxiety and depression. This may affect the quality of life and disease progression. However, there is still uncertainty about the extent of the problem.

OBJECTIVE: This meta-analysis aimed to determine the prevalence of depression and anxiety symptoms in patients with CRS.

SEARCH STRATEGY: We searched PubMed, Embase, Web of Science, Cochrane Library, and CBM databases for relevant studies published before 15 July 2022 in patients with CRS with concomitant depression and anxiety symptoms.

DATA COLLECTION AND ANALYSIS: Two authors independently performed screening and quality assessment using validated tools. Extraction of data using predefined standardised data collection spreadsheets. Heterogeneity and inconsistency were checked using the I² statistic.

RESULTS: The meta-analysis included 32 articles involving 56 933 patients. The prevalence of depression and anxiety symptoms was estimated at 24.7% (95% CI, 21.3% to 28. 1%) and 29.7% (95% CI, 19.3% to 40.2%). Subgroup analysis revealed the following: (1) CRS without nasal polyps (CRSsNP): 26.2% (95% CI, 21.9% to 30.5%), CRS with nasal polyps(CRSwNP): 20% (95% CI, 15.9% to 24%); (2) Female patients: 36. 1% (95% CI, 25.3% to 46.9%), male patients: 24.3% (95% CI, 12. 1% to 36.6%); and (3) The average age≤50 years patients: 29.8% (95% CI, 21.3% to 38.2%), the average age>50 years patients: 22. 1% (95% CI, 17.1% to 27%).

CONCLUSION: A significant proportion of people with CRS have symptoms of depression and anxiety, and early screening for depression and anxiety in people with CRS is critical. And, more attention needs to be given to females and patients with CRSsNP during screening.

PROSPERO REGISTRATION NUMBER: CRD42022345959).

PMID:38490652 | DOI:10.1136/bmjopen-2023-079273

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Nevin Manimala Statistics

Pesticides in surface water of the Ondas river watershed, western Bahia, Brazil: Spatial-seasonal distribution and risk assessment

Chemosphere. 2024 Mar 13:141659. doi: 10.1016/j.chemosphere.2024.141659. Online ahead of print.

ABSTRACT

This study investigated the occurrence and seasonal distribution of different classes of pesticides in surface waters of the Ondas River Watershed, as well as potential risks to the aquatic health and human water consumption in the western region of Bahia state, Brazil. Two gas chromatography-mass spectrometry analytical methods were applied to monitor 34 pesticides in water samples collected during both the dry and rainy seasons at 17 sites. Upon individual analysis, only γ-HCH, methoxychlor, demeton-S, methyl parathion, fenitrothion, chlorpyrifos, and azoxystrobin exhibited statistically significant differences between seasons. During rainy season, concentration medians of residues were higher for γ-HCH (74.7 ng L-1), methoxychlor (25.1 ng L-1), and azoxystrobin (47.2 ng L-1), potentially linked to historical contamination or illegal use. Conversely, pesticides like methyl parathion, fenitrothion, and chlorpyrifos, belonging to the organophosphate class, showed higher concentration medians in the dry period, measuring 75.1, 5.50, and 10.8 ng L-1, respectively, probably due to region crop activities. The risk quotient (RQ) assessment for aquatic life indicated that 59.0% of the samples in the dry season and 76.0% in the rainy season had RQ values greater than one, signifying a critical scenario for species conservation. Regarding human consumption, elevated risks were observed for heptachlor in both sampling periods and for azoxystrobin during the rainy season, surpassing RQ levels above 1, indicating danger in untreated water ingestion. Additionally, 24.0% and 53.0% of the samples in the dry and rainy seasons, respectively, contained at least one pesticide exceeding the EU resolution limit (100 ng L-1). Therefore, considering this information, implementing mitigation measures to avoid the river’s contamination becomes imperative.

PMID:38490616 | DOI:10.1016/j.chemosphere.2024.141659

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Performance of the IMPACT and CRASH prognostic models for traumatic brain injury in a contemporary multicenter cohort: a TRACK-TBI study

J Neurosurg. 2024 Mar 15:1-13. doi: 10.3171/2023.11.JNS231425. Online ahead of print.

ABSTRACT

OBJECTIVE: The International Mission on Prognosis and Analysis of Clinical Trials in Traumatic Brain Injury (IMPACT) and Corticosteroid Randomization After Significant Head Injury (CRASH) prognostic models for mortality and outcome after traumatic brain injury (TBI) were developed using data from 1984 to 2004. This study examined IMPACT and CRASH model performances in a contemporary cohort of US patients.

METHODS: The prospective 18-center Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study (enrollment years 2014-2018) enrolled subjects aged ≥ 17 years who presented to level I trauma centers and received head CT within 24 hours of TBI. Data were extracted from the subjects who met the model criteria (for IMPACT, Glasgow Coma Scale [GCS] score 3-12 with 6-month Glasgow Outcome Scale-Extended [GOSE] data [n = 441]; for CRASH, GCS score 3-14 with 2-week mortality data and 6-month GOSE data [n = 831]). Analyses were conducted in the overall cohort and stratified on the basis of TBI severity (severe/moderate/mild TBI defined as GCS score 3-8/9-12/13-14), age (17-64 years or ≥ 65 years), and the 5 top enrolling sites. Unfavorable outcome was defined as GOSE score 1-4. Original IMPACT and CRASH model coefficients were applied, and model performances were assessed by calibration (intercept [< 0 indicated overprediction; > 0 indicated underprediction] and slope) and discrimination (c-statistic).

RESULTS: Overall, the IMPACT models overpredicted mortality (intercept -0.79 [95% CI -1.05 to -0.53], slope 1.37 [1.05-1.69]) and acceptably predicted unfavorable outcome (intercept 0.07 [-0.14 to 0.29], slope 1.19 [0.96-1.42]), with good discrimination (c-statistics 0.84 and 0.83, respectively). The CRASH models overpredicted mortality (intercept -1.06 [-1.36 to -0.75], slope 0.96 [0.79-1.14]) and unfavorable outcome (intercept -0.60 [-0.78 to -0.41], slope 1.20 [1.03-1.37]), with good discrimination (c-statistics 0.92 and 0.88, respectively). IMPACT overpredicted mortality and acceptably predicted unfavorable outcome in the severe and moderate TBI subgroups, with good discrimination (c-statistic ≥ 0.81). CRASH overpredicted mortality in the severe and moderate TBI subgroups and acceptably predicted mortality in the mild TBI subgroup, with good discrimination (c-statistic ≥ 0.86); unfavorable outcome was overpredicted in the severe and mild TBI subgroups with adequate discrimination (c-statistic ≥ 0.78), whereas calibration was nonlinear in the moderate TBI subgroup. In subjects ≥ 65 years of age, the models performed variably (IMPACT-mortality, intercept 0.28, slope 0.68, and c-statistic 0.68; CRASH-unfavorable outcome, intercept -0.97, slope 1.32, and c-statistic 0.88; nonlinear calibration for IMPACT-unfavorable outcome and CRASH-mortality). Model performance differences were observed across the top enrolling sites for mortality and unfavorable outcome.

CONCLUSIONS: The IMPACT and CRASH models adequately discriminated mortality and unfavorable outcome. Observed overestimations of mortality and unfavorable outcome underscore the need to update prognostic models to incorporate contemporary changes in TBI management and case-mix. Investigations to elucidate the relationships between increased survival, outcome, treatment intensity, and site-specific practices will be relevant to improve models in specific TBI subpopulations (e.g., older adults), which may benefit from the inclusion of blood-based biomarkers, neuroimaging features, and treatment data.

PMID:38489823 | DOI:10.3171/2023.11.JNS231425

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Nevin Manimala Statistics

The identification of risk factors and outcomes of cerebrospinal fluid shunt infections caused by carbapenem-resistant gram-negative bacteria in children: a retrospective cohort

J Neurosurg Pediatr. 2024 Mar 15:1-11. doi: 10.3171/2024.1.PEDS23363. Online ahead of print.

ABSTRACT

OBJECTIVE: Cerebrospinal fluid (CSF) shunt infections caused by gram-negative bacteria are difficult to treat given the limited treatment options and the emergence of carbapenem-resistant (CR) strains. This study aimed to evaluate the demographic and clinical characteristics of children with CSF shunt and external ventricular drain (EVD) infections caused by gram-negative bacteria, to identify the risk factors for acquiring CR CSF shunt infections, and to report on the clinical outcomes of these infections.

METHODS: A retrospective cohort study was designed to evaluate pediatric patients with CSF shunt and EVD infections caused by gram-negative bacteria between January 2013 and February 2023.

RESULTS: A total of 64 episodes in 50 patients were evaluated. There were 45 (70.3%) CSF shunt infections and 19 (29.7%) EVD infections. The median (range) ages were 1.4 years (9 months-17.5 years) for CSF shunt infection patients and 4.2 years (1 month-17 years) for EVD infection patients. The most common isolated gram-negative bacteria species in CSF shunt infections were Pseudomonas spp. (12, 26.7%), followed by Escherichia coli (11, 24.4%), Klebsiella pneumoniae (9, 20%), and Enterobacter cloacae (5, 11.1%). In EVD infections, the most common isolated gram-negative bacteria species were Acinetobacter spp. (6, 31.6%), followed by Pseudomonas spp. (4, 21.1%) and E. coli (3, 15.8%). The carbapenem resistance rate was 26.3% (n = 5) in EVD infections and 26.2% (n = 11) in CSF shunt infections. When risk factors for carbapenem resistance were evaluated for CSF shunt infections, prior carbapenem treatment and a prolonged hospital stay > 7 days were risk factors for the CR group (p = 0.032 and p = 0.042, respectively). In definitive treatment, colistin was statistically more commonly used in the CR group (p = 0.049). When outcomes were evaluated, the 30-day mortality rate (18.2% vs 0%) was higher in the CR group, without a significant difference (p = 0.064).

CONCLUSIONS: A prolonged hospital stay > 7 days and prior carbapenem exposure within 30 days were associated with CR shunt infections caused by gram-negative bacteria.

PMID:38489813 | DOI:10.3171/2024.1.PEDS23363

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Pediatric brain tumors in sub-Saharan Africa: a systematic review and meta-analysis

J Neurosurg Pediatr. 2024 Mar 15:1-12. doi: 10.3171/2024.1.PEDS23282. Online ahead of print.

ABSTRACT

OBJECTIVE: Brain tumors are a global problem, leading to higher cancer-related morbidity and mortality rates in children. Despite the progressive though slow advances in neuro-oncology care, research, and diagnostics in sub-Saharan Africa (SSA), the epidemiological landscape of pediatric brain tumors (PBTs) remains underestimated. This study aimed to systematically analyze the distribution of PBT types in SSA.

METHODS: Ovid Medline, Global Index Medicus, African Journals Online, Google Scholar, and faculty of medicine libraries were searched for literature on PBTs in SSA published before October 29, 2022. A proportional meta-analysis was performed.

RESULTS: Forty-nine studies, involving 2360 children, met the inclusion criteria for review; only 20 (40.82%) were included in the quantitative analysis. South Africa and Nigeria were the countries with the most abundant data. Glioma not otherwise specified (NOS) was the common PBT in the 4 SSA regions combined. However, medulloblastoma was more commonly reported in Southern SSA (p = 0.01) than in other regions. The prevalence and the overall pooled proportion of the 3 common PBTs was estimated at 46.27% and 0.41 (95% CI 0.32-0.50, 95% prediction interval [PI] 0.11-0.79), 25.34% and 0.18 (95% CI 0.14-0.21, 95% PI 0.06-0.40), and 12.67% and 0.12 (95% CI 0.09-0.15, 95% PI 0.04-0.29) for glioma NOS, medulloblastoma, and craniopharyngioma, respectively. Sample size moderated the estimated proportion of glioma NOS (p = 0.02). The highest proportion of craniopharyngiomas was in Western SSA, and medulloblastoma and glioma NOS in Central SSA.

CONCLUSIONS: These findings provide insight into the trends of PBT types and the proportion of the top 3 most common tumors across SSA. Although statistical conclusions are difficult due to the inconsistency in the data, the study identifies critical areas for policy development and collaborations that can facilitate improved outcomes in PBTs in SSA. More accurate epidemiological studies of these tumors are needed to better understand the burden of the disease and the geographic variation in their distribution, and to raise awareness in their subsequent management.

PMID:38489811 | DOI:10.3171/2024.1.PEDS23282