Tag: statistics

Eur J Cardiovasc Nurs. 2023 Dec 26:zvad138. doi: 10.1093/eurjcn/zvad138. Online ahead of print.

ABSTRACT

AIM: Shared decision-making is recommended for patients considering treatment options for severe aortic stenosis (AS) and chronic coronary artery disease (CAD). This review aims to systematically identify and assess patient decision aids (PtDAs) for chronic CAD and AS and evaluate the international evidence on their effectiveness for improving the quality of decision-making.

METHODS AND RESULTS: Five databases (Cochrane, CINAHL, Embase, MEDLINE, PsycInfo), clinical trial registers and 30 PtDA repositories/websites were searched from 2006 to March 2023. Screening, data extraction and quality assessments were completed independently by multiple reviewers. Meta-analyses were conducted using Stata statistical software. Eleven AS and 10 CAD PtDAs were identified; seven were less than five years old. Over half the PtDAs were web-based and the remainder paper-based. One AS and two CAD PtDAs fully/partially achieved international PtDA quality criteria. Ten studies were included in the review; four reported on the development/evaluation of AS PtDAs and six on CAD PtDAs. Most studies were conducted in the USA with White, well-educated, English-speaking participants. No studies fulfilled all quality criteria for reporting PtDA development and evaluation. Meta-analyses found that PtDAs significantly increased patient knowledge compared to ‘usual care’ (mean difference:0.620; 95%CI 0.396, 0.845, p < 0.001) but did not change decisional conflict.

CONCLUSION: Patients who use PtDAs when considering treatments for AS or chronic CAD are likely to be better informed than those who do not. Existing PtDAs may not meet the needs of people with low health literacy levels as they are rarely involved in their development.

PMID:38147507 | DOI:10.1093/eurjcn/zvad138

Orthopedics. 2023 Dec 28:1-7. doi: 10.3928/01477447-20231220-05. Online ahead of print.

ABSTRACT

OBJECTIVE: This study sought to understand trends in industry payments for research awarded to orthopedic surgeons.

MATERIALS AND METHODS: The Centers for Medicare & Medicaid Services Open Payments database was queried for the years 2016 to 2021 for industry payments for research. Financial analyses were performed to understand temporal trends and differences by orthopedic subspecialty and principal investigator characteristics such as sex. The threshold for statistical significance was set at .05.

RESULTS: A total of 2014 orthopedic surgeons were identified, among whom 542 adult reconstruction (27%) and 460 sports medicine (23%) surgeons were major beneficiaries. Seventy-one female orthopedic surgeons comprised the minority (4%). Total research payments awarded during the study period aggregated to $266,633,592, with adult reconstruction ($88,819,047; 33%) and sports medicine ($57,949,822; 22%) receiving the highest amounts. Total research payments awarded trended upward yearly except for a decline in 2020 that subsequently rebounded (P<.001). Median annual research payment per orthopedic surgeon was $13,375. Median total industry payments per orthopedic surgeon differed between specialties (P <.001), with the highest amounts for adult reconstruction ($44,063) and sports medicine ($34,567) and the lowest amounts for hand ($12,052) and foot and ankle ($19,233). Median total payments did not differ significantly when stratified by sex (P=.276) and region (P=.906). Specialties in which the respective top three companies offered the majority of the research funding were musculoskeletal oncology (90%), pediatric orthopedics (66%), and shoulder and elbow (64%).

CONCLUSION: These results can be used as a primer for orthopedic surgeons seeking to leverage industry relationships to fund translational research. [Orthopedics. 202x;4x(x):xx-xx.].

PMID:38147497 | DOI:10.3928/01477447-20231220-05

Orthopedics. 2023 Dec 28:1-4. doi: 10.3928/01477447-20231220-03. Online ahead of print.

ABSTRACT

OBJECTIVE: Treating high-level athletes involves a balance between early and safe return to play. Various types of protective immobilization have been recommended after operatively treated Bennett’s fracture. The purpose of this study was to investigate if hand-based immobilization offers protection equivalent to forearm-based immobilization.

MATERIALS AND METHODS: A cadaveric model of Bennett’s fracture was created in 8 fresh-frozen, cadaveric forearms. Osteosynthesis was performed using a single headless compression screw. Three matched pairs were casted in either hand-based or forearm length, thumb spica casts, while 2 specimens remained un-casted as controls. Specimens were mounted on a custom testing apparatus. Weights were added in 6.8-kg increments until fixation failed and the fracture displaced. Fluoroscopy was performed after each trial. We used the Kruskal-Wallis non-parametric test to compare the groups. We considered P<.05 statistically significant.

RESULTS: Failure of fixation occurred at 6.8 kg in the control specimens. Fixation failed in hand-based and forearm length casts at a mean of 18.1±5.1 kg. We did not find a statistically significant difference between median values of load at failure in kilograms across control specimens and 2 immobilization categories (P=.114). All specimens in the hand-based group sustained additional wrist injuries, while no additional injuries were noted in the forearm length group.

CONCLUSION: Our study results showed that hand-based immobilization provides equivalent protection against fixation failure for operatively treated Bennett’s fractures but may predispose athletes to increased risk of wrist injury compared with traditional, forearm-based casting. [Orthopedics. 202x;4x(x):xx-xx.].

PMID:38147495 | DOI:10.3928/01477447-20231220-03

J Eur Acad Dermatol Venereol. 2023 Dec 26. doi: 10.1111/jdv.19770. Online ahead of print.

ABSTRACT

BACKGROUND: Hidradenitis suppurativa (HS) is a disease with an unmet need for treatment.

OBJECTIVE: To examine tolerability, safety and efficacy of oral phosphodiesterase-4 (PDE4) inhibitior orismilast 10-40 mg twice daily (BID) in HS.

METHODS: A Phase 2a, single-arm, single-centre, open-label, 16-week trial in HS patients. Adjustments in maximal dose and titration were allowed, to improve tolerability, dividing the study population in two groups who completed and discontinued 16 weeks of treatment. Descriptive statistics were applied to efficacy data from patients who completed treatment and patients who discontinued treatment prematurely. A last-observation-carried-forward (LOCF) approach was used for patients who discontinued treatment. The primary endpoint was percent change in the total number of abscesses and nodules (AN-count) at Week 16, with the HS Clinical Response with a 50% reduction in the AN-count (HiSCR50) as key secondary endpoint.

RESULTS: Of the 20 patients included, 9 completed 16 weeks of treatment and 11 discontinued treatment prematurely. The mean AN-count was reduced with 33.1% in patients who completed treatment and with 12.0% in patients who discontinued. HiSCR50 was achieved by 67.0% and 27.0% of patients who completed and discontinued treatment, respectively. Most adverse events were mild to moderate.

CONCLUSIONS: Oral orismilast demonstrated a dose-dependent tolerability, with mild to moderate adverse effects. Further, the results of this exploratory trial indicate that orismilast may lead to clinical improvements in HS. However, larger trials with tolerable dose ranges are warranted. The Trial is registered at Clinicaltrials.gov (UNI50007201) and EudraCT.ema.europa.eu (2021-000049-42).

PMID:38147438 | DOI:10.1111/jdv.19770

Dis Colon Rectum. 2023 Dec 26. doi: 10.1097/DCR.0000000000003034. Online ahead of print.

ABSTRACT

BACKGROUND: Variations in survival outcomes are observed in the American Joint Committee on Cancer’s 8th edition TNM staging system.

OBJECTIVE: Machine learning ensemble methods were used to develop and evaluate the effectiveness of a pathological-features-modified tumor node metastasis staging system in predicting survival for patients with rectal cancer by using commonly reported pathological features, such as histological grade, tumor deposits, and perineural invasion, to improve the prognostic accuracy.

DESIGN: This was a retrospective population-based study.

SETTINGS: Data were assessed from the database of the Surveillance, Epidemiology, and End Results Program.

PATIENTS: The study cohort comprised 14,468 rectal cancer patients diagnosed between 2010 and 2015. The development cohort included those who underwent surgery as the primary treatment while patients who received neoadjuvant therapy were assigned to the validation cohort.

MAIN OUTCOME MEASURES: The primary outcome measures included cumulative rectal cancer survival, adjusted hazard ratios, and both calibration and discrimination statistics to evaluate model performance and internal validation.

RESULTS: Multivariable Cox regression analysis identified all three pathological features as prognostic factors, following which patients were categorized into four pathological groups based on the number of pathological features (i.e., 0, 1, 2, and 3). Distinct survival differences were observed among the groups, especially with stage III patients. The proposed pathological-features-modified tumor-node-metastasis staging outperformed the TNM staging in both the development and validation cohorts.

LIMITATIONS: Retrospective in design and lack of external validation.

CONCLUSIONS: The proposed pathological-features-modified tumor-node-metastasis staging could complement the current TNM staging by improving the accuracy of rectal cancer patients’ survival estimation. See Video Abstract.

PMID:38147435 | DOI:10.1097/DCR.0000000000003034

J Biomol Struct Dyn. 2023 Dec 26:1-16. doi: 10.1080/07391102.2023.2295972. Online ahead of print.

ABSTRACT

Malate dehydrogenase (MDH) exists in multimeric form in normal and extreme solvent conditions where residues of the interface are involved in specific interactions. The interface salt-bridge (ISB) and its microenvironment (ME) residues may have a crucial role in the stability and specificity of the interface. To gain insight into this, we have analyzed 218 ISBs from 42 interfaces of 15 crystal structures along with their sequences. Comparative analyses demonstrate that the ISB strength is ∼30 times greater in extremophilic cases than that of the normal one. To this end, the interface residue propensity, ISB design and pair selection, and ME-residue’s types, i.e., type-I and type-II, are seen to be intrinsically involved. Although Type-I is a common type, Type-II appears to be extremophile-specific, where the net ME-residue count is much lower with an excessive net ME-energy contribution, which seems to be a novel interface compaction strategy. Furthermore, the interface strength can be enhanced by selecting the desired mutant from the net-energy profile of all possible mutations of an unfavorable ME-residue. The study that applies to other similar systems finds applications in protein-protein interaction and protein engineering.Communicated by Ramaswamy H. Sarma.

PMID:38147414 | DOI:10.1080/07391102.2023.2295972

Pain. 2023 Dec 22. doi: 10.1097/j.pain.0000000000003143. Online ahead of print.

ABSTRACT

It is not known why some patients develop persistent pain after nerve trauma while others do not. Among multiple risk factors for the development of persistent posttrauma and postsurgical pain, a neuropathic mechanism due to iatrogenic nerve lesion has been proposed as the major cause of these conditions. Because there is some evidence that the human leukocyte antigen (HLA) system plays a role in persistent postsurgical pain, this study aimed to identify the genetic risk factors, specifically among HLA loci, associated with chronic neuropathic pain after traumatic nerve injuries and surgery in the upper extremities. Blood samples were taken to investigate the contribution of HLA alleles (ie, HLA-A, HLA-B, HLA-DRB1, HLA-DQB1, and HLA-DPB1) in a group of patients with persistent neuropathic pain (n = 70) and a group of patients with neuropathy without pain (n = 61). All subjects had intraoperatively verified nerve damage in the upper extremity. They underwent bedside clinical neurological examination to identify the neuropathic pain component according to the present grading system of neuropathic pain. Statistical analyses on the allele and haplotype were conducted using the BIGDAWG package. We found that the HLA haplotype A*02:01-B*15:01-C*03:04-DRB1*04:01-DQB1*03:02 was associated with an increased risk of developing persistent neuropathic pain in the upper extremity (OR = 9.31 [95% CI 1.28-406.45], P < 0.05). No significant associations were found on an allele level when correcting for multiple testing. Further studies are needed to investigate whether this association is on a haplotypic level or if certain alleles may be causing the association.

PMID:38147413 | DOI:10.1097/j.pain.0000000000003143

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(12):116-123. doi: 10.17116/jnevro2023123121116.

ABSTRACT

OBJECTIVE: To investigate the associations of OPRM1 gene rs179971, OPRK1 gene rs6473797 and DCC gene rs8084280 polymorphisms with non-suicidal self-injury (NSSI) characteristics and motivations in adults.

MATERIAL AND METHODS: A pilot sample included 28 adult patients with history of NSSI (89.3% (n=25) women, median age (Q₁-Q₃) – 23 (21.25-25) years). Most patients (78.6%, n=20) had a diagnosis of bipolar disorder. NSSI characteristics and motivations were assessed using the Inventory of Statements about Self-Injury (ISAS) scale. The Childhood Trauma Questionnaire (CTQ) was used to control for childhood trauma – one of the most important environmental factors associated with NSSI. The Baratt Impulsivity Scale (BIS) and the Buss-Perry Aggression Questionnaire (BPAQ) were also used to assess impulsivity and aggression, respectively. RT-PCR was used for genotyping, a genetic effect was assessed using the dominant model. Mann-Whitney U-test, Pearson χ²-test and multiple linear regression were used for statistical analysis.

RESULTS: Carriers of the minor G allele of OPRM1 gene rs1779971 had a higher level of aggression assessed by BPAQ (p=0.02). The minor C allele of OPRK1 gene rs6473797 was associated with an increase of the subjective importance of «Affect regulation» (B=2.23; CI 95% [0.39-4.06]; p=0.022) and «Anti-dissociation» (B=3.31; CI 95% [0.18-6.44]; p=0.039) motivations, whereas the minor T allele of DCC gene rs8084280, on the contrary, was associated with a decrease of the importance of «Affect regulation» (B=-1.74; CI 95% [-3.30 – -0.18]; p=0.032). Moreover, this effect was found after adjusting for diagnosis, sex, age, and the presence of childhood trauma.

CONCLUSIONS: To our knowledge, this is the first study on the association of genetic markers with NSSI motivations. The results of this pilot study demonstrate that OPRK1 and DCC gene polymorphisms can determine differences in motivations for self-harm, however, these results require confirmation in large samples.

PMID:38147391 | DOI:10.17116/jnevro2023123121116

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(12):93-98. doi: 10.17116/jnevro202312312193.

ABSTRACT

OBJECTIVE: Clarification of the phenomenology and dynamics of initial mental disorders in patients with psychotic pubertal forms of schizophrenia, identification of the features of these disorders depending on sex.

MATERIAL AND METHODS: The study material was adolescent patients with psychotic forms of schizophrenia. Forty-three people were examined (women 44.2%, median age 14.3 [13.0; 16.8] years). Clinical-anamnestic, clinical-psychopathological, clinical-statistical methods were used.

RESULTS: The duration of the initial stage of the disease ranged from several hours to 5 years (median 0.8 [0.5; 1.7]. The structure of initial disorders was dominated by nonspecific mental disorders characterized by a combination of symptoms of non-psychotic and subpsychotic levels (20 patients – 43.5%; including 12 males – 26% and 8 females – 24.1% ). If behavioral disorders and episodes of psychoactive substance use were significantly more often detected in boys, then dysmorphic phenomena were detected in girls (p<0.05). In accordance with the dynamics of development, acute (n=14 – 32%), subacute (n=21 – 49%), fluctuating (n=8 – 19%) variants of initial disorders are distinguished. Young men turned to a psychiatrist in a more timely manner (already at the stage of prodrome), while girls sought psychiatric help only at the stage of development of psychotic disorders.

CONCLUSION: A psychotic episode in adolescents suffering from schizophrenia developed acutely in a third of cases. In the vast majority of cases, the initial mental disorders that appeared on the eve of acute psychosis was subacute, or differed in a fluctuating course, characterized by clinical polymorphism and multidirectionality. Differences were revealed in the preference for the occurrence of a number of initial disorders in boys and girls, as well as in the timeliness of seeking psychiatric help.

PMID:38147388 | DOI:10.17116/jnevro202312312193

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(12):83-92. doi: 10.17116/jnevro202312312183.

ABSTRACT

OBJECTIVE: To study the phenomenon of impulsivity, its components and aggression in patients at risk for schizophrenia at the stage of remission after the first depressive episode.

MATERIAL AND METHODS: Forty-eight male patients (mean age 19.4±2.9 years) with the first depressive episode (ICD-10 F32.1, F32.2) with attenuated positive, negative and/or disorganized symptoms were examined. According to the severity of impulsivity, the patients were divided into the clinical group (n=26) with pathological impulsivity and the comparison group (n=27) without it. The control group consisted of 41 mentally healthy young men, students of higher education of 1-3 courses, (mean age 19.7±1.6 years). HDRS, SOPS, SANS, Barratt Impulsiveness Scale (BIS-11) and Buss Perry Aggression Questionnaire (BPAQ) were used. Statistical analysis was carried out using the Statistica 12 software.

RESULTS: The differences between the clinical group and the comparison group were determined by the total score of the subscale of general symptoms of SOPS at admission (53 [41.75; 56] and 45.5 [41.75; 51.25], respectively) (U=187.5; p=0.037) and at discharge (28 [19; 37] and 25 [17.75; 29.25] points respectively) (U=166.5; p=0.012), according to the total HDRS score at admission (35 [31; 38] and 29 [26; 34.25]) (U=191.0; p=0.046). In the clinical group, the motor component of impulsivity and the factor of general impulsivity on the BIS-11 correlated with the severity of aggression on the BPAQ (r=0.395, p<0.05 and r=0.635, p<0.05, respectively). Significant differences were revealed in the clinical group depending on the presence of negative symptoms on the corresponding SOPS subscale according to the total BPAQ score (p=0.01). Correlation analysis showed numerous connections: positive between the total aggressiveness score and the duration of depression (p<0.05), negative between the factors of self-control, consistency, attention, and total scores on the SANS and SOPS (p<0.05).

CONCLUSION: We identify the differences in the structure of impulsivity in patients at risk of developing schizophrenia at the stage of remission after the first depressive state, the comparison group and the control group, as well as the relationship of impulsivity factors with individual clusters of psychopathological disorders.

PMID:38147387 | DOI:10.17116/jnevro202312312183