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Nevin Manimala Statistics

Drug shortages in low- and middle-income countries: Colombia as a case study

J Pharm Policy Pract. 2022 Jun 13;15(1):42. doi: 10.1186/s40545-022-00439-7.

ABSTRACT

BACKGROUND: Drug shortages are a global problem. Analyzing shortages worldwide is important to identify possible relationships between drug shortages across countries, determine strategies that reduce drug shortages, and reduce the inequality in access to medicines between countries. In contrast to well-documented shortages in high-income countries, there are few studies that consider low- and middle-income economies. We evaluate drug shortages in one middle-income country, Colombia.

METHODS: We collected data from INVIMA, the institution responsible for managing medicine shortage alerts in Colombia. We classified the data using the Anatomical Therapeutic Chemical (ATC) classification system and analyzed them using descriptive statistics. We considered a study period from 2015 to 2021 (vital medicines) and from 2010 to 2020 (non-vital medicines).

RESULTS: In total, 173 unique ATC codes were in shortage. These included antidotes, alimentary tract and metabolism products, anesthetics, cardiac stimulants and antithrombotic agents. The major causes were manufacturing problems and few suppliers. Drug shortages substantially increased from 2020 to May 2021 due to the COVID-19 pandemic. Among resolved shortages, the average duration was 1.6 years with a standard deviation of 1.9 years. The longest, naloxone tablets, were in shortage for almost 10 years.

CONCLUSIONS: Drug shortages are a persistent problem in Colombia. Government institutions have made progress in implementing systems and procedures to report them. However, the approaches implemented need to be maintained and refined. This study lays the groundwork for the analysis of drug shortages in other LMICs. We highlight the necessity of addressing drug shortages in their global context and reducing the inequality in access to medicines between countries.

PMID:35698240 | DOI:10.1186/s40545-022-00439-7

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Nevin Manimala Statistics

The sit-to-stand test as a patient-centered functional outcome for critical care research: a pooled analysis of five international rehabilitation studies

Crit Care. 2022 Jun 13;26(1):175. doi: 10.1186/s13054-022-04048-3.

ABSTRACT

BACKGROUND: With ICU mortality rates decreasing, it is increasingly important to identify interventions to minimize functional impairments and improve outcomes for survivors. Simultaneously, we must identify robust patient-centered functional outcomes for our trials. Our objective was to investigate the clinimetric properties of a progression of three outcome measures, from strength to function.

METHODS: Adults (≥ 18 years) enrolled in five international ICU rehabilitation studies. Participants required ICU admission were mechanically ventilated and previously independent. Outcomes included two components of the Physical Function in ICU Test-scored (PFIT-s): knee extensor strength and assistance required to move from sit to stand (STS); the 30-s STS (30 s STS) test was the third outcome. We analyzed survivors at ICU and hospital discharge. We report participant demographics, baseline characteristics, and outcome data using descriptive statistics. Floor effects represented ≥ 15% of participants with minimum score and ceiling effects ≥ 15% with maximum score. We calculated the overall group difference score (hospital discharge score minus ICU discharge) for participants with paired assessments.

RESULTS: Of 451 participants, most were male (n = 278, 61.6%) with a median age between 60 and 66 years, a mean APACHE II score between 19 and 24, a median duration of mechanical ventilation between 4 and 8 days, ICU length of stay (LOS) between 7 and 11 days, and hospital LOS between 22 and 31 days. For knee extension, we observed a ceiling effect in 48.5% (160/330) of participants at ICU discharge and in 74.7% (115/154) at hospital discharge; the median [1st, 3rd quartile] PFIT-s difference score (n = 139) was 0 [0,1] (p < 0.05). For STS assistance, we observed a ceiling effect in 45.9% (150/327) at ICU discharge and in 77.5% (79/102) at hospital discharge; the median PFIT-s difference score (n = 87) was 1 [0, 2] (p < 0.05). For 30 s STS, we observed a floor effect in 15.0% (12/80) at ICU discharge but did not observe a floor or ceiling effect at hospital discharge. The median 30 s STS difference score (n = 54) was 3 [1, 6] (p < 0.05).

CONCLUSION: Among three progressive outcome measures evaluated in this study, the 30 s STS test appears to have the most favorable clinimetric properties to assess function at ICU and hospital discharge in moderate to severely ill participants.

PMID:35698237 | DOI:10.1186/s13054-022-04048-3

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Nevin Manimala Statistics

A comparative analysis of pediatric mental health-related emergency department utilization in Montréal, Canada, before and during the COVID-19 pandemic

Ann Gen Psychiatry. 2022 Jun 13;21(1):17. doi: 10.1186/s12991-022-00398-y.

ABSTRACT

BACKGROUND: Reports on longitudinal trends in mental health-related (MHR) emergency department (ED) utilization spanning the pre- and post-pandemic periods are lacking, along with evidence comparing healthcare services utilization by sociodemographic subgroups. The aim of this study was to evaluate COVID-19-associated changes in MHR ED utilization among youth overall and by age, sex, and socio-economic status (SES).

METHODS: This retrospective cross-sectional study analyzed MHR ED utilization before and during the COVID-19 pandemic at a large urban pediatric tertiary care hospital in Montréal, Canada. All ED visits for children (5-11 years) and adolescents (12-17 years) between April 1, 2016 and November 30, 2021 were included. The main outcome was the monthly count of MHR ED visits. Pre-pandemic and pandemic periods were compared using an interrupted time series design. The effect of seasonality (in months), age (in years), sex (male or female), and SES (low, average, high) were compared using a generalized additive model.

RESULTS: There were a total of 437,147 ED visits (204,215 unique patients) during the 5-year study period of which 9748 (5.8%) were MHR visits (7,686 unique patients). We observed an increase of 69% (95% CI, + 53% to + 85%; p = 0.001) in the mean monthly count of MHR ED visits during the pandemic period, which remained significant after adjusting for seasonality (44% increase, 95% CI, + 38% to + 51%; p = 0.001). The chance of presenting for a MHR ED visit increased non-linearly with age. There were increased odds of presenting for a MHR ED visit among girls between the pre-pandemic and pandemic periods (OR 1.42, 95% CI 1.29-1.56). No difference by SES group during and before the COVID-19 pandemic was found [OR 1.01, 95% CI 0.89-1.15 (low); OR 1.09, 95% CI 0.96-1.25 (high)].

CONCLUSIONS: Our study shows important increases in MHR ED utilization among youth, and especially among girls, during the first 20 months of the COVID-19 pandemic, highlighting the need for sustained, targeted and scalable mental health resources to support youth mental health during the current and future crises.

PMID:35698227 | DOI:10.1186/s12991-022-00398-y

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Nevin Manimala Statistics

Do health sector measures of violence against women at different levels of severity correlate? Evidence from Brazil

BMC Womens Health. 2022 Jun 13;22(1):226. doi: 10.1186/s12905-022-01813-y.

ABSTRACT

OBJECTIVE: To evaluate if characteristics of reports of violence against women at different levels of severity are similar and to test if their prevalence is correlated at the municipal level.

METHODS: I use data from women ages 15-49 who were killed by homicide in Brazil’s national death registry (N = 14,373), were hospitalized for aggression (N = 14,701), or were included in the medical mandatory reports of incidents of violence against women (N = 42,134) between 2011 and 2016 in select municipalities. I provide national level descriptive statistics from 2016 contrasting distributions of victims (age, education, and race) and distributions of the characteristics of the incidents (location and time of day). Then, for 63 municipalities with a high number of violent incidents, I calculate the correlation coefficients between measures of violence against women using quarterly data from 2011 to 2016. I use multiple regression of municipal characteristics at baseline to examine which factors (poverty, spending, health, and civic engagement) predict the correlation.

RESULTS: Victim characteristics and incident characteristics are similar across the measures of violence at the national level. Despite these aggregate similarities, correlations at the municipal level are quite varied, ranging from – 0.69 to 0.83. I find no municipal characteristics that consistently predict these correlation coefficients.

CONCLUSIONS: Despite some similarities at an aggregate level, these measures of violence against women do not have consistent patterns of correlation at the municipality level. Measures of severe levels of violence against women are not good proxies for incidence of violence at less severe physical levels. Lack of correlations could be due to differences in reporting, but may also be due to differences in underlying processes that share similar victims and event characteristics.

PMID:35698218 | DOI:10.1186/s12905-022-01813-y

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Nevin Manimala Statistics

Integrative medicine during the intensive phase of chemotherapy in pediatric oncology in Germany: a randomized controlled trial with 5-year follow up

BMC Cancer. 2022 Jun 13;22(1):652. doi: 10.1186/s12885-022-09703-0.

ABSTRACT

BACKGROUND: Integrative medicine is used frequently alongside chemotherapy treatment in pediatric oncology, but little is known about the influence on toxicity. This German, multi-center, open-label, randomized controlled trial assessed the effects of complementary treatments on toxicity related to intensive-phase chemotherapy treatment in children aged 1-18 with the primary outcome of the toxicity sum score. Secondary outcomes were chemotherapy-related toxicity, overall and event-free survival after 5 years in study patients.

METHODS: Intervention and control were given standard chemotherapy according to malignancy & tumor type. The intervention arm was provided with anthroposophic supportive treatment (AST); given as anthroposophic base medication (AMP), as a base medication for all patients and additional on-demand treatment tailored to the intervention malignancy groups. The control was given no AMP. The toxicity sum score (TSS) was assessed using NCI-CTC scales.

RESULTS: Data of 288 patients could be analyzed. Analysis did not reveal any statistically significant differences between the AST and the control group for the primary endpoint or the toxicity measures (secondary endpoints). Furthermore, groups did not differ significantly in the five-year overall and event-free survival follow up.

DISCUSSION: In this trial findings showed that AST was able to be safely administered in a clinical setting, although no beneficial effects of AST between group toxicity scores, overall or event-free survival were shown.

PMID:35698215 | DOI:10.1186/s12885-022-09703-0

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Nevin Manimala Statistics

Analysis of 55 patients with multiple endocrine neoplasia type 1-associated insulinoma from a single center in China

Orphanet J Rare Dis. 2022 Jun 13;17(1):219. doi: 10.1186/s13023-022-02370-1.

ABSTRACT

OBJECTIVE: To investigate the clinical characteristics of patients with multiple endocrine neoplasia type 1 (MEN1)-related insulinoma and their relationship with specific biochemical changes and to summarize the features of treatment options for the Chinese population with this disease and the impact on long-term prognosis.

METHODS: “MEN1” and “insulinoma” were used when searching the Peking Union Medical College Hospital (PUMCH) medical record retrieval system to obtain clinical information about patients. We identified patients diagnosed with MEN1-associated insulinoma based on endocrinological, radiological, and pathological examinations, and subsequently analyzed their clinical data.

RESULTS: A total of 55 patients with MEN1-associated insulinoma were included, including 29 (52.7%) men and 26 (47.3%) women. The parathyroid gland was the most commonly affected (78.2%), followed by the pituitary gland (69.1%) and adrenal gland (16.4%). Insulinoma was the first manifestation of MEN1 in at least 23.6% (13/55) of patients. Nineteen (34.5%) patients presented with initial symptoms of hypoglycemia before the age of 22 years. Among the 24 Patients with high serum calcium (Ca) had significantly lower serum insulin levels than those with normal serum Ca levels (p < 0.001) during hypoglycemic episodes. However, serum C-peptide level at 0.5 h and serum insulin level at 1 h was higher in patients with hypercalcemia than in patients with normal serum Ca levels in the oral glucose tolerance test (OGTT), although the differences were not statistically significant. Multifocal pancreatic neuroendocrine tumors (pNETs) were present in 38 (69.1%) patients; most of them (55.6%, 20/36) underwent multiple enucleations, and 45% (9/20) had a postoperative recurrence. Five patients (10%) who underwent distal pancreatectomy developed pancreatic insufficiency after an average of seven years. patients who underwent genetic testing, 23 (95.8%) were positive for MEN1 mutation, with mutations most commonly found in exons 2 (21.7%) and 3 (13%).

CONCLUSIONS: In our study, the rates of postoperative recurrence and long-term complications in patients with MEN1 with multifocal pNETs were significantly different from those in other international centers and might be related to the choice of surgical method. In addition, elevated serum Ca levels in patients with primary hyperparathyroidism may affect insulin secretion.

PMID:35698198 | DOI:10.1186/s13023-022-02370-1

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Nevin Manimala Statistics

Immune characteristics of children with autoimmune encephalitis and the correlation with a short-term prognosis

Ital J Pediatr. 2022 Jun 13;48(1):94. doi: 10.1186/s13052-022-01247-0.

ABSTRACT

BACKGROUND: Autoimmune encephalitis (AE) is a type of encephalopathy mediated by an antigenic immune response in the central nervous system. Most research related to autoimmune encephalitis (AE) is focused on early diagnosis, treatment and prognosis analysis; there has been little research conducted on the characteristics of immune function, and the relationship between immune function and prognoses of patients with autoimmune encephalitis needs to be studied further.

METHODS: A total of 33 children with autoimmune encephalitis were identified through the clinic database and inpatient consults at Tianjin Children’s Hospital from January 2013 to January 2021. Based on the one-year follow-up and the modified Rankin Scale (mRS) prognosis score, they were divided into a good prognosis group and a poor prognosis group. The immune function characteristics of the two groups of children with autoimmune encephalitis (AE) were compared using Spearman correlation to analyse the mRS score and immune function indicators (IgA, IgG, IgM, CD4, CD8, CD4/CD8), and binary logistic regression was used to analyse the independent risk factors of the prognoses in patients with autoimmune encephalitis (AE).

RESULTS: The differences in abnormal mental disorders and limb dyskinesia, cognitive impairment, onset types, modified Rankin Scale (mRS) scores at admission, and immune function status during remission between the two groups were statistically significant (p < 0.05).

CONCLUSION: There is a close correlation between modified Rankin Scale (mRS) scores and the immune function index CD4/CD8 in children with autoimmune encephalitis (AE) when they are admitted to the hospital. A young age, disturbance of consciousness, limb dyskinesia, abnormal immune function in remission and anti-NMDAR encephalitis are risk factors for poor prognoses in children with autoimmune encephalitis (AE). Clinical treatment requires more attention.

PMID:35698204 | DOI:10.1186/s13052-022-01247-0

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Nevin Manimala Statistics

Teamwork quality and health workers burnout nexus: a new insight from canonical correlation analysis

Hum Resour Health. 2022 Jun 13;20(1):52. doi: 10.1186/s12960-022-00734-z.

ABSTRACT

BACKGROUND: Burnout is evidenced to have adverse effect on the well-being of health workers. Although several risk factors of burnout have been found, only a hand full of studies have examined the role of teamwork quality. This study therefore sought to explore the relationship between the sub-dimensions of burnout and teamwork quality.

METHOD: This is an empirical study involving health workers who have practising certificate from the National Health Commission of the People’s Republic of China. Relying on the study’s target population, a sample of 939 healthworkers complied to partake in the survey. Data were obtained from the administration of a well-structured electronic questionnaire containing the Maslach Burnout Inventory together with Healthy and Resilient Organization (HERO) scales correspondingly. The scales were then analysed using the canonical correlation approach (CCA).

RESULTS: The results unveiled a statistically significant correlation between teamwork quality and health worker burnout indicating that teamwork quality and burnout are canonically correlated. Further, examination on the relationship existing between the dimensions of teamwork quality and burnout unveiled that with the exception of personal accomplishment and teamwork dedication, teamwork quality sub-scales (teamwork vigour and teamwork absorption) were negatively related to emotional exhaustion and depersonalization as sub-scales of burnout, respectively.

CONCLUSION: The study concluded that, surge in teamwork quality leads to reduced emotional exhaustion and reduced depersonalization while simultaneously increasing professional accomplishment. Therefore, this study presents a solid foundation for decreasing burnout syndrome in healthcare that can be implemented by successfully increasing levels of teamwork quality.

PMID:35698190 | DOI:10.1186/s12960-022-00734-z

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Nevin Manimala Statistics

Sepsis: emerging pathogens and antimicrobial resistance in Ethiopian referral hospitals

Antimicrob Resist Infect Control. 2022 Jun 13;11(1):83. doi: 10.1186/s13756-022-01122-x.

ABSTRACT

BACKGROUND: Sepsis due to multidrug resistant (MDR) bacteria is a growing public health problem mainly in low-income countries.

METHODS: A multicenter study was conducted between October 2019 and September 2020 at four hospitals located in central (Tikur Anbessa and Yekatit 12), southern (Hawassa) and northern (Dessie) parts of Ethiopia. A total of 1416 patients clinically investigated for sepsis were enrolled. The number of patients from Tikur Anbessa, Yekatit 12, Dessie and Hawassa hospital was 501, 298, 301 and 316, respectively. At each study site, blood culture was performed from all patients and positive cultures were characterized by their colony characteristics, gram stain and conventional biochemical tests. Each bacterial species was confirmed using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI TOF). Antimicrobial resistance pattern of bacteria was determined by disc diffusion. Logistic regression analysis was used to assess associations of dependent and independent variables. A p-value < 0.05 was considered as statistically significant. The data was analyzed using SPSS version 25.

RESULTS: Among 1416 blood cultures performed, 40.6% yielded growth. Among these, 27.2%, 0.3% and 13.1%, were positive for pathogenic bacteria, yeast cells and possible contaminants respectively. Klebsiella pneumoniae (26.1%), Klebsiella variicola (18.1%) and E. coli (12.4%) were the most frequent. Most K. variicola were detected at Dessie (61%) and Hawassa (36.4%). Almost all Pantoea dispersa (95.2%) were isolated at Dessie. Rare isolates (0.5% or 0.2% each) included Leclercia adecarboxylata, Raoultella ornithinolytica, Stenotrophomonas maltophilia, Achromobacter xylosoxidans, Burkholderia cepacia, Kosakonia cowanii and Lelliottia amnigena. Enterobacteriaceae most often showed resistance to ampicillin (96.2%), ceftriaxone (78.3%), cefotaxime (78%), cefuroxime (78%) and ceftazidime (76.4%). MDR frequency of Enterobacteriaceae at Hawassa, Tikur Anbessa, Yekatit 12 and Dessie hospital was 95.1%, 93.2%, 87.3% and 67.7%, respectively. Carbapenem resistance was detected in 17.1% of K. pneumoniae (n = 111), 27.7% of E. cloacae (n = 22) and 58.8% of Acinetobacter baumannii (n = 34).

CONCLUSION: Diverse and emerging gram-negative bacterial etiologies of sepsis were identified. High multidrug resistance frequency was detected. Both on sepsis etiology types and MDR frequencies, substantial variation between hospitals was determined. Strategies to control MDR should be adapted to specific hospitals. Standard bacteriological services capable of monitoring emerging drug-resistant sepsis etiologies are essential for effective antimicrobial stewardship.

PMID:35698179 | DOI:10.1186/s13756-022-01122-x

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Effect of tumor necrosis factor inhibitors on risk of cardiovascular disease in patients with axial spondyloarthritis

Arthritis Res Ther. 2022 Jun 13;24(1):141. doi: 10.1186/s13075-022-02836-4.

ABSTRACT

BACKGROUND: Axial spondyloarthritis (axSpA) is associated with an increased risk of cardiovascular disease. We aimed to evaluate the effect of tumor necrosis factor inhibitors (TNFis) on the risk of cardiovascular disease in patients with axSpA.

METHODS: This retrospective study included 450 patients with axSpA without pre-existing cardiovascular disease. The outcome was incident cardiovascular disease (myocardial infarction or stroke) after the diagnosis of axSpA. The effect of TNFis on cardiovascular risk was analyzed in the total study population and in an inverse probability of treatment weighting (IPTW)-adjusted population. Cox proportional hazards models were used to estimate the hazard ratios (HRs) and 95% confidence intervals (95% CIs) for cardiovascular disease, according to exposure to TNFis.

RESULTS: Of the 450 patients, 233 (51.8%) and 217 (48.2%) patients were and were not exposed to TNFis, respectively. Twenty cardiovascular diseases occurred during 2868 person-years of follow-up (incidence rate: 6.97/1000 person-years). In the total study population, exposure to TNFis was associated with a reduced cardiovascular risk when adjusted for traditional cardiovascular risk factors (HR 0.30, 95% CI 0.10-0.85, p = 0.024). However, when time-averaged erythrocyte sedimentation rate and C-reactive protein were additionally adjusted, this association was attenuated and lost statistical significance (HR 0.37, 95% CI 0.12-1.12, p = 0.077). Furthermore, in the IPTW-adjusted population, exposure to TNFis showed no significant reduction in cardiovascular risk (HR 0.60, 95% CI 0.23-1.54, p = 0.287).

CONCLUSIONS: Although controlling inflammation through TNFis could be beneficial in cardiovascular risk reduction, our data indicate no TNFi-specific reduction in cardiovascular risk in patients with axSpA.

PMID:35698171 | DOI:10.1186/s13075-022-02836-4