Nevin Manimala

BMC Musculoskelet Disord. 2021 Oct 19;22(1):888. doi: 10.1186/s12891-021-04750-3.

ABSTRACT

BACKGROUND: New minimally invasive treatments are vital to delay joint replacement surgery in patients with knee osteoarthritis. This study was designed to select the most effective among three formulations of an enhanced protein solution containing clonidine, hyaluronic acid, and human plasma (JTA-004), and compare the safety and efficacy of intra-articular administration of the selected formulation with a reference treatment (hyaluronic acid) in symptomatic knee osteoarthritis patients.

METHODS: In this two-stage, double-blind, phase II/III study conducted in 12 Belgian centers, 50-79-year-old patients with primary knee osteoarthritis were randomized (1:1:1:1) to receive one dose of one of three JTA-004 formulations (differing in clonidine concentration [50 or 100 μg/ml] and volume [2 or 4 ml]) or the reference treatment (hylan G-F 20). Patients were evaluated using Western Ontario McMaster Universities (WOMAC®) Scores and the Short-Form health survey up to 6 months post-injection (Month 6). Drug consumption and safety were evaluated.

RESULTS: Among 164 treated patients, 147 completed the study. The JTA-004 formulation containing 200 μg clonidine and 20 mg hyaluronic acid in 2 ml (JTA-200/2) was selected based on interim results at Month 6. The difference in adjusted mean change in WOMAC Pain Subscale Score from baseline (JTA-200/2 minus reference group) at Month 6 was – 9.49 mm; statistical superiority of JTA-200/2 over the reference was not demonstrated. No statistically significant differences in adjusted mean changes from baseline between JTA-200/2 and reference groups were observed for Pain, Physical Function and Stiffness Subscales WOMAC Scores, Total WOMAC Score, and Well-being Score at any timepoint, although JTA-200/2 induced larger improvements in WOMAC Scores than the reference. Statistically significantly larger improvements in WOMAC Pain Subscale Scores for JTA-004 versus the reference were observed in post-hoc analyses on pooled data from all JTA-004 formulations at Month 6 (p = 0.030) and Month 3 (p = 0.014). All JTA-004 formulations had clinically acceptable safety profiles.

CONCLUSIONS: This study provided preliminary evidence of the safety of intra-articular injection of JTA-004 in knee osteoarthritis patients. Phase III randomized controlled trials with larger sample sizes are needed to evaluate the efficacy of JTA-004 in knee osteoarthritis.

TRIAL REGISTRATION: Clinicaltrials.gov/identifier NCT02740231; clinicaltrialsregister.eu/identifier 2015-002117-30. Retrospectively registered 13/4/2016.

PMID:34666767 | DOI:10.1186/s12891-021-04750-3

World J Surg Oncol. 2021 Oct 19;19(1):306. doi: 10.1186/s12957-021-02418-9.

ABSTRACT

BACKGROUND: Sentinel lymph node biopsy is the gold standard surgical technique for axillary staging in patients with clinically node-negative. However, it is still uncertain what is the optimal number of sentinel lymph nodes (SLNs) to be removed to reduce the false-negative rate. The aim of this study was to investigate whether patients with a single negative SLN have a worse prognosis than those with two or more negative SLNs.

METHODS: A retrospective review was conducted on a large series of SLN-negative breast cancer patients. Survival outcomes and regional recurrence rate were evaluated according to the number of removed SLNs. Secondly, the contribution of different adjuvant therapies on disease-free survival was explored. Statistical analysis included the chi-square, Wilcoxon-Mann-Whitney test, and Kaplan-Meier survival analysis.

RESULTS: A total of 1080 patients were included in the study. A first group consisted of 328 patients in whom a single SLN was retrieved, and a second group consisted of 752 patients in whom two or more SLNs were retrieved. There was no relevant difference in median DFS (64.9 vs 41.4) for SLN = 1 vs SLN > 1 groups (HR 0.76, CI 95% 0.39-1.46; p = 0.38). A statistically significant difference in mDFS was showed only for HT-treated patients who were SLN = 1 if compared to SLN > 1 (100.6 months versus 35.3 months).

CONCLUSIONS: There is likely a relationship between the number of resected SNL and mDFS. Our results, however, showed no relevant difference in median DFS for SLN = 1 vs SLN > 1 group, except for a subset of the patients treated with hormone therapy.

PMID:34666764 | DOI:10.1186/s12957-021-02418-9

BMC Nurs. 2021 Oct 19;20(1):202. doi: 10.1186/s12912-021-00692-2.

ABSTRACT

BACKGROUND: Delirium is more prevalent in older people and estimated to occur in up to 50% of the hospital population. Delirium comprises a spectrum of behaviours, including cognitive and attention deficits, and fluctuating levels of consciousness, often associated with an underlying physiological disturbance. Delirium has been increasingly associated with adverse outcomes. Although often preventable or can at least be mitigated, delirium may not be a standard part of assessment and thus may not be recognized in the early stages when it is most likely to be treated successfully. The aim of this study was to evaluate the level of knowledge of delirium amongst clinicians caring for patients at high risk of developing delirium and to determine whether education can improve clinical assessment of delirium.

METHODS: Two hundred and forty-six case notes were audited before and 149 were reviewed after the education intervention and implementation of a delirium screening tool. Clinicians at the hospital were invited to complete a questionnaire on knowledge of delirium. The questionnaire was based on a validated tool which contained 39 questions about delirium. The questionnaire also contained 28 questions on delirium knowledge. Additional questions were included to gather demographic information specific to the hospital. Descriptive statistics, chi square and independent t-tests were conducted to test for differences in knowledge between the pre and post periods. The Squire Checklist Reporting Guidelines for Quality Improvement Studies informed the preparation of the manuscript.

RESULTS: The audit demonstrated that the use of a cognitive assessment tool overall increased from 8.5% in pre education to 43% in the post education period. One hundred and fifty-nine staff completed the questionnaire in total, 118 the pre and 41 post. The knowledge subscale score was high pre and post education and no statistically significant difference was observed. The greatest increase in knowledge was related to knowledge of the risk factors subscale. The increase in knowledge (6.8%) was statistically significant.

CONCLUSION: An interprofessional approach to delirium education was effective in not only increasing awareness of the factors associated with this syndrome but also increased the use of a delirium assessment tool.

PMID:34666763 | DOI:10.1186/s12912-021-00692-2

BMC Nurs. 2021 Oct 19;20(1):203. doi: 10.1186/s12912-021-00727-8.

ABSTRACT

BACKGROUND: Job embeddedness and professional self-concept are among the important nursing components, the existence of which help decrease occupational burnout among nurses. This study aimed to determine the protective role of Professional Self-concept and Job embeddedness on nurses’burnout.

METHODS: This descriptive, correlational study had a predictive design and was conducted on nurses working in training and healthcare centers of Babol University of Medical Sciences in 2019. In total, 308 nurses participated in this study and were selected by stratified random sampling. In addition, data were collected using demographic characteristics questionnaire, Professional Self-concept questionnaire, Job embeddedness scale and nurses’ burnout questionnaire. Moreover, data analysis was performed in SPSS version 25 and Smart PLS version 3.3 using correlational statistics and structural equation modeling.

RESULTS: Both the variables of professional self-concept and job embeddedness, had a significant effect on nurses’ burnout at 99% confidence level (P < 0.001) and the negative beta value for these two variables shows the inverse relationship between both professional self-concept and job embeddedness with nurses’ burnout. The value of the coefficient of determination for burnout indicates that both the variables of professional self-concept and job embeddedness, together explain 78% of the changes in the variable of burnout. The beta coefficient for professional self-concept (- 0.50) is higher than the same coefficient for job embeddedness (- 0.42). As a result, the role of professional self-concept in predicting burnout of clinical nurses has been more than the role of job embeddedness. The indirect effect of professional self-concept on burnout of clinical nurses mediated by job embeddedness has been equal to – 0.347. As a result, it can be said that nurses’ professional self-concept has a significant effect on nurses’ burnout through mediation of job embeddedness.

CONCLUSION: According to the results of the study, Professional Self-concept had an effective role in nurses’ burnout. In other words, the higher the Professional Self-concept of nurses, the lower their burnout. Therefore, it is suggested that effective interventional strategies be designed by nursing managers through better planning and a supportive workplace be established to improve Professional Self-concept among nurses and decrease their burnout.

PMID:34666759 | DOI:10.1186/s12912-021-00727-8

Homeopathy. 2021 Oct 19. doi: 10.1055/s-0041-1732307. Online ahead of print.

ABSTRACT

BACKGROUND/OBJECTIVE: During the coronavirus disease 2019 (COVID-19) pandemic, several homeopathic prognostic factor research (PFR) projects have been undertaken. We found two projects with comparable outcomes to assess consistency and possible flaws.

METHODS: Two comparisons were made. (1) Outcome of a PFR data collection from the Liga Medicorum Homoeopathica Internationalis (LMHI) by about 100 doctors with 541 cases was compared with a previous analysis of 161 cases in the same database. (2) The updated LMHI database was also compared with a data collection carried out in India by four doctors with a total of 1,445 cases. Differences that resulted in conflicting outcomes (indication in one, contraindication in the other) were examined for possible causes.

RESULTS: There was only a single outcome in the updated LMHI database that conflicted with the previous dataset, and this could have been due to statistical variation. The Indian data contained many cases, from few doctors, while the LMHI database had few cases per doctor, but many doctors. The overlap between the projects (individual cases entered in both) was between zero and 22%. In 72 comparisons we found six (8.3%) conflicting outcomes. Possible causes were statistical error due to small numbers of cases and/or observers, confirmation bias, and keynote prescribing if this resulted in symptoms being inadequately checked.

CONCLUSION: There was little conflict between the outcomes of the two versions of one project and between the two different PFR projects. Differences could mostly be explained by causes that can be managed. This consistency should primarily be interpreted as showing a strong overall consensus between homeopathic practitioners worldwide, but with variation of consensus between small groups of practitioners.

PMID:34666410 | DOI:10.1055/s-0041-1732307

Am J Perinatol. 2021 Oct 19. doi: 10.1055/s-0041-1736593. Online ahead of print.

ABSTRACT

OBJECTIVE: Hypoxic-ischemic encephalopathy (HIE) is the second cause of neonatal deaths and one of the main conditions responsible for long-term neurological disability. Contrary to past belief, children with mild HIE can also experience long-term neurological sequelae. The aim of this systematic review is to determine the predictive value of long-term neurological outcome of (electroencephalogram) EEG/amplitude-integrated electroencephalogram (aEEG) in children who complained mild HIE.

STUDY DESIGN: From a first search on PubMed, Google Scholar, and clinicalTrials.gov databases, only five articles were considered suitable for this study review. A statistical meta-analysis with the evaluation of odds ratio was performed on three of these studies.

RESULTS: No correlation was found between the characteristics of the electrical activity of the brain obtained through EEG/aEEG in infants with mild HIE and subsequent neurological involvement.

CONCLUSION: EEG/aEEG monitoring in infants with mild HIE cannot be considered a useful tool in predicting their neurodevelopmental outcome, and its use for this purpose is reported as barely reliable.

KEY POINTS: · Hypoxic-Ischemic Encephalopathy is responsible for long-term neurological outcome, even in newborns with mild HIE.. · No correlation was found between EEG/aEEG trace in infants with mild HIE and neurological sequelae.. · Neurophysiological monitoring, in mild HIE, cannot predic neurodevelopmental outcome..

PMID:34666398 | DOI:10.1055/s-0041-1736593

Am J Perinatol. 2021 Oct 19. doi: 10.1055/a-1673-0183. Online ahead of print.

ABSTRACT

BACKGROUND: Spontaneous intestinal perforation (SIP) occurs commonly in extremely low gestational age newborns (ELGANs; < 30 weeks GA). Early, concurrent neonatal use of indomethacin (Neo_IN) and hydrocortisone (Neo_HC), is a known risk for SIP. Mothers in premature labor often receive indomethacin (Mat_IN) for tocolysis and steroids (Mat_S) for fetal maturation. Coincidentally, ELGANs may receive Neo_IN or Neo_HC within the first week of life. There is limited data on the effect of combined exposures to maternal and neonatal medications. We hypothesized that proximity exposure to these medications may increase the risk of SIP.

DESIGN: We reviewed the medical records of ELGANS from June 2014 to December 2019 at a single Level III NICU. We compared antenatal and postnatal indomethacin and steroid use between neonates with and without SIP. Chi-Square, Student’s t-test, Fisher’s Exact test, and Mann-Whitney U tests were used for analysis.

RESULTS: Among 417 ELGANs, SIP was diagnosed in 23; predominantly neonates <26 weeks GA (n = 21/126, 16.7%). Risk factors analysis focused on this GA cohort in which SIP was most prevalent. Mat_IN administration within two days of delivery increased SIP risk (OR 3.00, 95%Cl 1.25-7.94, p=0.036). Neo_HC was not independently associated with SIP (p=0.38). A higher proportion of SIP group had close temporal exposure of Mat_IN and Neo_HC compared to the non-SIP group, though not statistically significant (14% v. 7%, p=0.24).

CONCLUSIONS: Peripartum Mat_IN was associated with increased risk for SIP in this small study sample. Larger studies are needed to further delineate SIP risk from the interaction of peripartum maternal medication with early postnatal therapies and disease pathophysiology.

PMID:34666387 | DOI:10.1055/a-1673-0183

Am J Perinatol. 2021 Oct 19. doi: 10.1055/a-1673-0708. Online ahead of print.

ABSTRACT

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic is associated with fewer deliveries and premature births; however, the impact of this pandemic on the well-baby nursery (WBN) is unknown.

OBJECTIVE: To evaluate the impact of the COVID-19 pandemic on infants admitted to the WBN by comparing pandemic and pre-pandemic cohorts.

STUDY DESIGN: We performed a retrospective study of infants admitted to a WBN during the pandemic period (March 18, 2020-to-March 17, 2021) and compared them to those during the pre-pandemic period (March 18, 2019-to-March 17, 2020). Maternal (age, parity, gestation, method of delivery, and COVID-19 status) and neonatal (sex, weight, Apgar score, feeding pattern, urine toxicology, and neonatal intensive care unit [NICU] admission) data were collected and compared between the two periods. The results were statistically analyzed, and significance was set at P < 0.05.

RESULTS: There were 824 and 859 WBN admissions during the pandemic and pre-pandemic periods, respectively; a 4% decrease in WBN admissions during the pandemic period. During the pandemic period, the number of deliveries among nulliparous women increased (from 40.3% to 45.1%; p=0.01), and deliveries among multiparous women decreased (from 59.2% to 53.1%; p=0.01). The number of infants exposed to marijuana in-utero increased (24/149 screened vs. 12/146 screened; p=0.038), and transfers from WBN to NICU decreased (from 9% to 6%; p=0.044) during the pandemic period.

CONCLUSIONS: Compared to the pre-pandemic period, the number of WBN admissions, multiparous deliveries, and NICU admissions decreased, while the number of nulliparous deliveries and infants exposed to marijuana in-utero increased during the pandemic period.

PMID:34666385 | DOI:10.1055/a-1673-0708

Am J Perinatol. 2021 Oct 19. doi: 10.1055/a-1673-0527. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine the rate of perinatal mortality among nulliparous women compared to primiparous women at term and further characterize the risk of stillbirth by each week of gestation.

STUDY DESIGN: A retrospective cohort study of all term, singleton, non-anomalous births comparing perinatal mortality (stillbirth and neonatal demise [NND]) between primiparous (parity=1, with no history of abortion) and nulliparous (parity = 0) women who delivered in California between 2007 and 2011. Chi squared tests and multivariable logistic regression analyses were performed to determine the frequencies and strength of association of perinatal mortality and parity, adjusting for maternal age, race, body mass index (BMI), pre-gestational diabetes, chronic hypertension, fetal sex, smoking status, and socioeconomic status. The risk of stillbirth at each gestational age at term was calculated using a pregnancies-at-risk life table method. A p-value less than 0.05 was used to indicate statistical significance.

RESULTS: Of 1,317,761 total deliveries, 765,995 (58.1%) were to nulliparous women and 551,766 (41.9%) were to primiparous women with one prior birth. Nulliparous women had increased odds of stillbirth (adjusted odds ratio [aOR] 3.30, 95% confidence interval (CI) 2.93-3.72) and NND (aOR 1.54, 95% CI 1.19-1.98) compared to primiparous women. The risk of stillbirth in nulliparous women was greater at every gestational age between 37 0/7 and 41 0/7 weeks compared to primiparous women. Nulliparous women also had increased odds of small for gestational age (SGA) infants at <10% birth weight (aOR 1.76, 95% CI 1.72-1.79), <5% birth weight (aOR 1.91, 95% CI 1.86-1.98), and <3% birth weight (aOR 2.02, 95% CI 1.93-2.11).

CONCLUSION: Perinatal mortality is significantly greater in nulliparous women compared to primiparous women with term deliveries. These findings suggest that low-risk nulliparous women may require increased surveillance. There may be a role in improving maternal health by maximizing physiologic adaptation in nulliparous women.

PMID:34666381 | DOI:10.1055/a-1673-0527

J Natl Compr Canc Netw. 2021 Oct 19:1-8. doi: 10.6004/jnccn.2021.7034. Online ahead of print.

ABSTRACT

BACKGROUND: Given a link between sarcomas and hereditary cancer predisposition syndromes, including Li-Fraumeni syndrome, the consideration for genetic counseling is recommended for all adolescent and young adult (AYA) patients diagnosed with sarcoma. The aim of this study was to evaluate factors influencing genetic consultations in AYA patients with sarcoma at the University of Wisconsin (UW).

METHODS: A retrospective chart review was performed on AYA patients diagnosed with sarcoma between the ages of 15 and 39 years who were seen at least once between 2015 to 2019 at UW. Our chart review identified discussions regarding genetics, referrals to genetics, genetic consultations, and results of genetic testing. Variables hypothesized to affect patient referrals for genetic consultation were identified a priori. Descriptive statistical methods and a univariate analysis were used to identify patient characteristics associated with genetic counseling referral.

RESULTS: We identified 87 AYA patients with sarcoma. Only 19 (22%) of these patients had documentation of a discussion about genetics, 15 (17%) of whom were subsequently referred for genetic consultation. Of these 15 patients, 9 (60%) were seen in consultation. All 9 patients seen by genetics underwent genetic testing, with 4 (44%) of these patients having identified heritable cancer predisposition syndromes. Likelihood for genetics referral was linked most strongly to documented genetics discussion with an oncology provider (P<.001).

CONCLUSIONS: Despite the recommendation for consideration for genetic counseling in AYA patients with sarcoma, <25% of such patients in our study had a documented discussion about genetics. Supporting this need, all referred patients met criteria for genetic testing, and 44% of tested patients were found to have a heritable cancer predisposition syndrome. These data support the initial conversation by a provider as critical to genetic referral and suggest the need for more specific national recommendations for the genetic evaluation of all AYA patients with sarcoma.

PMID:34666309 | DOI:10.6004/jnccn.2021.7034