Category: Nevin Manimala

J Clin Epidemiol. 2023 Mar 17:S0895-4356(23)00055-0. doi: 10.1016/j.jclinepi.2023.03.012. Online ahead of print.

ABSTRACT

BACKGROUND: In biomedical research, spin is the overinterpretation of findings, and it is a growing concern. To date, the presence of spin has not been evaluated in prognostic model research in oncology, including studies developing and validating models for individualised risk prediction.

STUDY DESIGN AND SETTING: We conducted a systematic review, searching MEDLINE and EMBASE for oncology-related studies that developed and validated a prognostic model using machine learning published between 01/01/2019 and 05/09/2019. We used existing spin frameworks and described areas of highly suggestive spin practices.

RESULTS: We included 62 publications (including 152 developed models; 37 validated models). Reporting was inconsistent between methods and the results in 27% of studies due to additional analysis and selective reporting. Thirty-two studies (out of 36 applicable studies) reported comparisons between developed models in their discussion and predominantly used discrimination measures to support their claims (78%). Thirty-five studies (56%) used an overly strong or leading word in their title, abstract, results, discussion or conclusion.

CONCLUSION: The potential for spin needs to be considered when reading, interpreting, and using studies that developed and validated prognostic models in oncology. Researchers should carefully report their prognostic model research using words that reflect their actual results and strength of evidence.

PMID:36935090 | DOI:10.1016/j.jclinepi.2023.03.012

J Shoulder Elbow Surg. 2023 Mar 17:S1058-2746(23)00260-4. doi: 10.1016/j.jse.2023.02.126. Online ahead of print.

ABSTRACT

BACKGROUND: Over the last few decades, several databases and clinical registries have been used to generate studies for orthopedic surgery research including shoulder arthroplasty. Observational database studies present data that is best used to provide information regarding associations between variables but is unable to prove causation. Yet, there remains a tendency for authors to use causal language and conclusive statements in published shoulder arthroplasty literature utilizing such databases.

METHODS: We systematically identified administrative database and registry studies on shoulder arthroplasty in five orthopedic journals from January 2020 to December 2021. Papers were independently graded by two reviewers for the presence, absence, or inconsistent use of causal language throughout the publication. Chi-squared analyses were conducted to determine the relationship between causality language and article characteristics including the journal of publication.

RESULTS: There were 65 eligible articles. 67.7% of titles and abstracts were considered either consistently causal or inconsistently causal in language and inference. When reviewing the full text, 69.2% contained some degree of causal language (38.5% consistently causal, 30.8% inconsistently causal). There were no statistically significant associations between the journal and title and abstract final grading (p = 0.863) or the journal and full text grading (p = 0.726).

CONCLUSION: The use of causal language remains highly prevalent in observational database studies related to shoulder arthroplasty. Understanding the limitations of observational database studies is paramount for accurate interpretation of these publications.

PMID:36935077 | DOI:10.1016/j.jse.2023.02.126

Am J Kidney Dis. 2023 Mar 17:S0272-6386(23)00574-7. doi: 10.1053/j.ajkd.2023.01.442. Online ahead of print.

ABSTRACT

RATIONALE & OBJECTIVE: The heart-kidney crosstalk is recognized as the cardiorenal syndrome. We examined the association of cardiac function and structure with the risk of kidney failure with replacement therapy (KFRT) in a chronic kidney disease (CKD) population.

STUDY DESIGN: Prospective observational cohort study.

SETTING & PARTICIPANTS: 3,027 participants from the Chronic Renal Insufficiency Cohort Study.

EXPOSURES: Five pre-selected variables that assess different aspects of cardiac structure and function: left ventricular mass index (LVMI), LV volume, left atrial (LA) area, peak tricuspid regurgitation (TR) velocity, and left ventricular ejection fraction (EF) as assessed by echocardiography.

OUTCOMES: Incident KFRT (primary outcome), and annual eGFR slope (secondary outcome).

ANALYTICAL APPROACH: Multivariable Cox models and mixed-effects models.

RESULTS: Mean age was 59 (SD 11) years, 54% were men, and mean eGFR was 43 (17) ml/min/1.73m². Between 2003 and 2018 (median follow-up, 9.9 years), 883 participants developed KFRT. Higher LVMI, LV volume, LA area, peak TR velocity, and lower EF were each statistically significantly associated with an increased risk of KFRT, with corresponding HRs for the highest vs. lowest quartiles (lowest vs. highest for EF) of 1.70 (95%CI, 1.27 to 2.26), 1.50 (1.19 to 1.90), 1.43 (1.11 to 1.84), 1.45 (1.06 to 1.96), and 1.26 (1.03 to 1.56), respectively. For secondary outcome, participants in the highest vs. lowest quartiles (lowest vs. highest for EF) had a statistically significantly faster eGFR decline, except for LA area (ΔeGFR slope per year, -0.57 [95%CI, -0.68 to -0.46] mL/min/1.73m² for LVMI, -0.25 [-0.35 to -0.15] mL/min/1.73m² for LV volume, -0.01 [-0.12 to -0.01] mL/min/1.73m² for LA area, -0.42 [-0.56 to -0.28] mL/min/1.73m² for peak TR velocity, and -0.11 [-0.20 to -0.01] mL/min/1.73m² for EF, respectively).

LIMITATIONS: The possibility of residual confounding.

CONCLUSIONS: Multiple aspects of cardiac structure and function were statistically significantly associated with the risk of KFRT. These findings suggest that cardiac abnormalities and incidence of KFRT are potentially on the same causal pathway related to the interaction between hypertension, heart failure, and coronary artery diseases.

PMID:36935072 | DOI:10.1053/j.ajkd.2023.01.442

Brain Behav. 2023 Mar 19:e2947. doi: 10.1002/brb3.2947. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Randomized controlled trials and observational studies of nabiximols oromucosal spray in patients with multiple sclerosis (MS) spasticity have shown improvement in a range of associated symptoms (pain, spasms, fatigue, bladder dysfunction, and sleep disturbances). This study evaluated the effectiveness and tolerability of add-on nabiximols in the routine management of patients with MS spasticity in Austria, with a focus on spasticity-associated symptoms.

METHODS: This was an open, prospective, multicenter, observational, non-interventional study of patients with MS spasticity receiving add-on treatment with nabiximols oromucosal spray. Main endpoints were patient-reported changes from baseline in the frequency (counts) or severity (mean Numerical Rating Scale [NRS] scores) of spasticity-associated symptoms, and patient-reported changes from baseline in impairment of daily activities due to spasticity, after 1 and 3 months of nabiximols treatment. No analyses were conducted for statistical significance.

RESULTS: There were 55 patients in the effectiveness population, and 62 in the safety population. Patients reported clinically relevant reductions from baseline to month 3 in the average number of spasms/day (-68.2%) and number of urinary incontinence episodes (-69.3%) in the week prior to the clinic visit, and reductions in mean 0-10 NRS scores for sleep impairment (-47.2%), fatigue (-26.4%), pain (40.4%), and spasticity severity (39.0%). There was no change from baseline in daily activity impairment due to spasticity. The majority of patients were at least partly satisfied with add-on nabiximols for spasticity-associated symptoms. There were 31 adverse events (27 treatment related) reported in 19 patients, with no new safety signals.

CONCLUSIONS: Add-on nabiximols improved the severity of MS spasticity and a range of spasticity-associated symptoms during real-world use in Austria. Nabiximols is an option for patients with MS spasticity who fail first-line oral antispasticity treatment.

PMID:36934456 | DOI:10.1002/brb3.2947

Clin Exp Dent Res. 2023 Mar 19. doi: 10.1002/cre2.719. Online ahead of print.

ABSTRACT

OBJECTIVES: The purpose was to conduct a comprehensive study of malocclusions and oral dysfunctions on 11-year-old children and to study the risk factors associated with malocclusions.

MATERIAL AND METHODS: A cross-sectional descriptive epidemiological survey was conducted among 359 children in France. A clinical examination was conducted, and orthodontic and oral functional data were collected. In addition, the need for orthodontic treatment was evaluated using the criteria defined by of the French National Authority for Health (HAS). Finally, a univariate and multivariate analysis was performed to assess the risks associated with malocclusions.

RESULTS: Most children (88%) exhibited a malocclusion, regardless of gender (p = .912). The examination of oral functions identified a large number of swallowing (87%) and respiration (42.7%) disorders. The presence of malocclusion was statistically linked to the low position of the tongue at rest (p < .001), abnormal swallowing (p = .03), and improper mouth breathing (p = .001). After a multivariate analysis, the type of respiration (odds ratio [OR] = 3.2 [1.4-7.3]) and the position of tongue at rest (OR = 3.43 [1.7-7.1]) were the two most prominent factors in the prediction of emerging malocclusion.

CONCLUSION: This epidemiological survey reveals a high prevalence of dental malocclusions and functional disorders. Oral respiration and the low position of the tongue at rest are the most important factors in the prediction of a malocclusion.

PMID:36934443 | DOI:10.1002/cre2.719

Cancer Med. 2023 Mar 19. doi: 10.1002/cam4.5801. Online ahead of print.

ABSTRACT

Salivary gland malignancies are rare and are often acompanied by poor prognoses. So, identifying the populations with risk factors and timely intervention to avoid disease progression is significant. This study provides an effective prediction model to screen the target patients and is helpful to construct a cost-effective follow-up strategy. We enrolled 249 patients diagnosed with salivary gland tumors and analyzed prognostic risk factors using Cox proportional hazard univariable and multivariable regression models. The patients’ data were split into training and validation sets on a 7:3 ratio, and the random survival forest (RSF) model was established using the training sets and validated using the validation sets. The maximally selected rank statistics method was used to determine a cut point value corresponding to the most significant relation with survival. Univariable Cox regression suggested age, smoking, alcohol consumption, untreated, neural invasion, capsular invasion, skin invasion, tumors larger than 4 cm, advanced T and N stage, distant metastasis, and non-mucous cell carcinoma were risk factors for poor prognosis, and multivariable analysis suggested that female, aging, smoking, untreated, and non-mucous cell carcinoma were risk factors. The time-dependent ROC curve showed the AUC of the RSF prediction model on 1-, 2-, and 3-year survival were 0.696, 0.779, and 0.765 respectively in the validation sets. Log-rank tests suggested that the cut point 7.42 risk score calculated from the RSF was most effective in dividing patients with significantly different prognoses. The prediction model based on the RSF could effectively screen patients with poor prognoses.

PMID:36934429 | DOI:10.1002/cam4.5801

Ann Intensive Care. 2023 Mar 19;13(1):20. doi: 10.1186/s13613-023-01111-2.

NO ABSTRACT

PMID:36934400 | DOI:10.1186/s13613-023-01111-2

Pediatr Surg Int. 2023 Mar 19;39(1):153. doi: 10.1007/s00383-023-05440-y.

ABSTRACT

PURPOSE: First, to assess the number of spinal cord anomalies (SCA), specifically tethered spinal cord (TSC) in patients with anorectal malformations (ARM), identified with spinal cord imaging (i.e. spinal cord US and/or MRI). Second, to report outcomes after TSC treatment.

METHODS: A retrospective mono-center study was performed. All ARM patients born between January 2000 and December 2021 were included. Screening for SCA consisted of spinal cord US and/or MRI. Radiology reports were scored on presence of SCA. Data were presented with descriptive statistics.

RESULTS: In total, 254 patients were eligible for inclusion, of whom 234 (92.1%) underwent spinal cord imaging. In total, 52 (22.2%) patients had a SCA, diagnosed with US (n = 20, 38.5%), MRI (n = 10, 19.2%), or both US and MRI (n = 22, 42.3%), of whom 12 (23.5%) with simple, 27 (52.7%) intermediate, and 12 (23.5%) complex ARM types. TSC was identified in 19 patients (8.1%), of whom 4 (21.1%) underwent uncomplicated neurosurgical intervention.

CONCLUSIONS: SCA were present in 22% of ARM patients both in simple, as well as more complex ARM types. TSC was present in 19 patients with SCA, of whom 4 underwent uncomplicated neurosurgical intervention. Therefore, screening for SCA seems to be important for all ARM patients, regardless of ARM type.

LEVEL OF EVIDENCE: Level III.

PMID:36934393 | DOI:10.1007/s00383-023-05440-y

J Sleep Res. 2023 Mar 19:e13878. doi: 10.1111/jsr.13878. Online ahead of print.

ABSTRACT

The orexin 2 receptor-selective agonist danavorexton (TAK-925) has been shown to produce wake-promoting effects in wild-type mice, narcolepsy-model mice, and individuals with narcolepsy type 1 and type 2. Here, we report wake-promoting effects of danavorexton in non-human primates and healthy men during their sleep phase. Electroencephalogram analyses revealed that subcutaneous administration of danavorexton significantly increased wakefulness in common marmosets (p < 0.05 at 0.1 mg kg^-1 , and p < 0.001 at 1 mg kg^-1 and 10 mg kg^-1 ) and cynomolgus monkeys (p ≤ 0.05 at 1 mg kg^-1 and 3 mg kg^-1 ). In a phase 1b crossover, randomized, double-blind, placebo-controlled and active-controlled study in sleep-deprived healthy participants (ClinicalTrials.gov identifier: NCT03522506), modafinil 300 mg (used to demonstrate assay sensitivity) and continuous infusion of danavorexton 44 mg and danavorexton 112 mg showed statistically superior wake-promoting effects to placebo (n = 18). Measured using the Maintenance of Wakefulness Test, mean (standard deviation) sleep latencies during infusion of danavorexton 44 mg, danavorexton 112 mg and placebo were 21.4 (8.9), 31.8 (3.2) and 9.2 (6.4) min, respectively. Least-squares mean difference from placebo in average sleep latency was 16.8 min with danavorexton 44 mg and 30.2 min with danavorexton 112 mg (both p < 0.001). Karolinska Sleepiness Scale scores were statistically significantly lower (indicating decreased sleepiness) for participants receiving danavorexton than for those receiving placebo during infusion (danavorexton 44 mg, p = 0.010; danavorexton 112 mg, p < 0.001). Together, these results indicate that an orexin 2 receptor agonist increases wakefulness in non-human primates and healthy individuals during their sleep phase.

PMID:36934366 | DOI:10.1111/jsr.13878

Age Ageing. 2023 Mar 1;52(3):afad022. doi: 10.1093/ageing/afad022.

ABSTRACT

BACKGROUND: Some hospital admissions of nursing home residents (NHRs) might be attributed to inadequate interprofessional collaboration. To improve general practitioner-nurse collaboration in nursing homes (NHs), we developed an intervention package (interprof ACT) in a previous study.

OBJECTIVE: To assess the impact of interprof ACT on the proportion of hospitalisation and other clinical parameters within 12 months from randomisation among NHRs.

METHODS: Multicentre, cluster randomised controlled trial in 34 German NHs. NHRs of the control group received usual care, whereas NHRs in the intervention group received interprof ACT. Eligible NHs had at least 40 long-term care residents. NHs were randomised 1:1 pairwise. Blinded assessors collected primary outcome data.

RESULTS: Seventeen NHs (320 NHRs) were assigned to interprof ACT and 17 NHs (323 NHRs) to usual care. In the intervention group, 136 (42.5%) NHRs were hospitalised at least once within 12 months from randomisation and 151 (46.7%) in the control group (odds ratio (OR): 0.82, 95% confidence interval (CI): [0.55; 1.22], P = 0.33). No differences were found for the average number of hospitalisations: 0.8 hospitalisations per NHR (rate ratio (RR) 0.90, 95% CI: [0.66, 1.25], P = 0.54). Average length of stay was 5.7 days for NHRs in the intervention group and 6.5 days in the control group (RR: 0.70, 95% CI: [0.45, 1.11], P = 0.13). Falls were the most common adverse event, but none was related to the study intervention.

CONCLUSIONS: The implementation of interprof ACT did not show a statistically significant and clinically relevant effect on hospital admission of NHRs.

PMID:36934341 | DOI:10.1093/ageing/afad022