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Nevin Manimala Statistics

Early specialised treatment for bipolar disorder: Long-term follow-up from the early intervention in affective disorders (EIA) randomised controlled trial

Acta Psychiatr Scand. 2024 Jun 2. doi: 10.1111/acps.13716. Online ahead of print.

ABSTRACT

BACKGROUND: It is unclear whether treatment early after onset in bipolar disorder may improve the long-term illness course. The early intervention in affective disorders (EIA) randomised controlled trial found that 2-years treatment in a specialised mood disorder clinic combining evidence-based pharmacological treatment with group psychoeducation improved clinical outcomes compared with standard treatment in patients with bipolar disorder discharged after their 1st, 2nd, or 3rd hospital admission. We aimed to assess the 16 years long-term outcomes after randomisation of the participants in the EIA trial.

METHODS: Data were obtained by linking nation-wide Danish population-based registers. All 158 participants of the EIA trial (Trial Registration Number NCT00253071) were followed from time of randomisation (2005-2009) to end of study (31 December 2021). The primary outcome was risk of psychiatric readmission. Secondary outcomes were total admissions and costs, medication use, intentional self-harm or suicide attempt or suicide, and socio-economic measures.

RESULTS: The absolute mean risk of psychiatric readmission was 49.3% in the intervention group and 59.8% in the control group, with no statistically significant difference between the groups (b = -0.10, 95% CI: -0.26 to 0.047, p = 0.18). Compared with the control group, patients in the intervention group had numerically fewer total admission days (mean (SD) 44 (77) versus 62 (109)), lower total cost of psychiatric hospital admissions and hospital-based outpatient visits (mean (SD) 22,001 (36793) euros versus 29,822 (52671) euros) and higher use of lithium and antipsychotics, but the differences were not statistically significant. Fewer patients in the intervention group had an event of intentional self-harm or suicide attempt or suicide during follow-up (OR 0.25, 95% CI: 0.15-0.40, p < 0.001) compared with the control group and more patients in the intervention group used antiepileptics (OR 2.21, 95% CI: 1.08-4.60, p = 0.031).

CONCLUSION: Analyses of very long-term outcomes of the EIA trial may potentially indicate a beneficial effect of the intervention at the long term but were likely underpowered to detect a more subtle effect and for most outcomes the differences between groups were not statistically significant.

PMID:38825333 | DOI:10.1111/acps.13716

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Nevin Manimala Statistics

Evaluation of a Fully Digital, In-House Virtual Surgical Planning Workflow for Bimaxillary Orthognathic Surgery

J Oral Maxillofac Surg. 2024 May 17:S0278-2391(24)00294-5. doi: 10.1016/j.joms.2024.05.002. Online ahead of print.

ABSTRACT

BACKGROUND: The advantages of virtual surgical planning (VSP) for orthognathic surgery are clear. Previous studies have evaluated in-house VSP; however, few fully digital, in-house protocols for orthognathic surgery have been studied.

PURPOSE: The purpose of this study was to evaluate the difference between the virtual surgical plan and actual surgical outcome for orthognathic surgery using a fully digital, in-house VSP workflow.

STUDY DESIGN, SETTING, SAMPLE: This is a prospective cohort study from September 2020 to November 2022 of patients at the Victoria General Hospital in Halifax, NS, Canada who underwent bimaxillary orthognathic surgery. Patients were excluded if they had previously undergone orthognathic surgery or were diagnosed with a craniofacial syndrome.

MAIN OUTCOME VARIABLES: The primary outcome variables were the mean 3-dimensional (3D) (Euclidean) distance error, as well as mean error and mean absolute error in the transverse (x axis), vertical (y axis), and anterior-posterior (z axis) dimensions.

COVARIATES: Covariates included age, sex, and surgical sequence (mandible-first or maxilla-first).

ANALYSES: The primary outcome was tested using Z and t critical value confidence intervals. The P value was set at .05. The 3D distance error for mandible-first and maxilla-first groups was compared using a 2-sample t-test as well as analysis of variance.

RESULTS: The study sample included 52 subjects (24 males and 28 females) with a mean age of 27.7 (± 12.1) years. Forty three subjects underwent mandible-first surgery and 9 maxilla-first surgery. The mean absolute distance error was largest in the anterior-posterior dimension for all landmarks (except posterior nasal spine, left condyle, and gonion) and exceeded the threshold for clinical acceptability (2 mm) in 16 of 23 landmarks. Additionally, mean distance error in the anterior-posterior dimension was negative for all landmarks, indicating deficient movement in that direction. The effect of surgical sequence on 3D distance error was not statistically significant (P = .37).

CONCLUSION AND RELEVANCE: In general, the largest contributor to mean 3D distance error was deficient movement in the anterior-posterior direction. Otherwise, mean absolute distance error in the vertical and transverse dimensions was clinically acceptable (< 2 mm). These findings were felt to be valuable for treatment planning purposes when using a fully digital, in-house VSP workflow.

PMID:38825321 | DOI:10.1016/j.joms.2024.05.002

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Nevin Manimala Statistics

Comparison of Ankle Fracture Fixation Using Intramedullary Fibular Nailing Versus Plate Fixation

J Foot Ankle Surg. 2024 May 31:S1067-2516(24)00094-2. doi: 10.1053/j.jfas.2024.05.004. Online ahead of print.

ABSTRACT

Ankle fracture fixation using intramedullary fibular (IMF) nails has been shown to allow for earlier weightbearing, reduced wound complications, better union rates, and the absence of prominent hardware, compared to plates/screw (PS) constructs. The purpose of present retrospective cohort study was to compare outcomes of patients who underwent ankle fracture fixation using an IMF nail versus PS. Demographic, clinical, and radiographic data were recorded for patients who underwent ankle fracture fixation between May 2020 and May 2022, and who were at least 1 year postoperative. Toe-touch weightbearing was permitted immediately after surgery, protected weightbearing (PWB) at postoperative week 2, and weightbearing as tolerated in a brace at week 6. Radiographs were assessed preoperatively, and at 2, 6, 12, 24, and 48 weeks postoperative. Sixty-one ankle fractures (30 IMF, 31 PS) with a mean follow up of 14.7 and 18 (range, 12 to 23) months were included. Overall, the IMF nail cohort had less pain, faster time to union (11.4 vs 13.2 weeks), and less complications (23% vs 45%), reoperations (10% vs 16%), and surgical failures (9% vs 9.7%), compared to the PS cohort. The differences were not statistically significant. The PS cohort had a higher rate of symptomatic hardware irritation (p=<0.001). Tobacco use adversely effected direct osseous healing (p<0.001) and increased postoperative complications (p=0.050). The present study lends credence to the previously reported advantages of IMF nailing over PS fixation for ankle fractures. Ankle fracture fixation using a 4th generation, IMF nail is a viable alternative to traditional PS fixation.

PMID:38825307 | DOI:10.1053/j.jfas.2024.05.004

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Nevin Manimala Statistics

Lessons Learned Establishing the Palliative Care Research Cooperative’s Qualitative Data Repository

J Pain Symptom Manage. 2024 May 31:S0885-3924(24)00797-8. doi: 10.1016/j.jpainsymman.2024.05.027. Online ahead of print.

ABSTRACT

Data sharing is increasingly an expectation in health research as part of a general move toward more open sciences. In the United States, in particular, the implementation of the 2023 National Institutes of Health Data Management and Sharing Policy has made it clear that qualitative studies are not exempt from this data sharing requirement. Recognizing this trend, the Palliative Care Research Cooperative Group (PCRC) realized the value of creating a de-identified qualitative data repository to complement its existing de-identified quantitative data repository. The PCRC Data Informatics and Statistics Core leadership partnered with the Qualitative Data Repository (QDR) to establish the first serious illness and palliative care qualitative data repository in the U.S. We describe the processes used to develop this repository, called the PCRC-QDR, as well as our outreach and education among the palliative care researcher community, which led to the first ten projects to share the data in the new repository. Specifically, we discuss how we co-designed the PCRC-QDR and created tailored guidelines for depositing and sharing qualitative data depending on the original research context, establishing uniform expectations for key components of relevant documentation, and the use of suitable access controls for sensitive data. We also describe how PCRC was able to leverage its existing community to recruit and guide early depositors and outline lessons learned in evaluating the experience. This work advances the establishment of best practices in qualitative data sharing.

PMID:38825257 | DOI:10.1016/j.jpainsymman.2024.05.027

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Nevin Manimala Statistics

The value of patient-reported outcomes to predict for symptom burden and health-related quality of life after chemoradiation for cervical cancer: A prospective study

Pract Radiat Oncol. 2024 May 31:S1879-8500(24)00135-8. doi: 10.1016/j.prro.2024.04.025. Online ahead of print.

ABSTRACT

PURPOSE: Cervical cancer patients undergoing chemoradiation have high symptom burden. We performed an analysis of prospectively collected patient-reported outcomes(PROs) to determine characteristics predictive of poor treatment experience.

METHODS: Between 2021-2023, we prospectively collected PROs from cervical cancer patients undergoing definitive chemoradiation. EORTC-QLQ-C30 and EORTC-QLQ-CX24 were completed at baseline(BL) and at the end of treatment(EOT). Poor treatment experience was defined as EOT poor health-related quality of life (HRQOL), low physical function, or significant overall symptom burden. Predictive factors analyzed included demographic, clinical, disease-specific factors, and baseline financial toxicity, depression, social function, and emotional function. ROC analysis provided appropriate predictive cut-off values. Univariable(UVA) and multivariable(MVA) linear regression analyses were performed.

RESULTS: Fourty-nine patients completed BL and EOT questionnaires. Median age was 43 (range, 18-85). Most patients (59%) had stage III disease. Baseline financial toxicity ≥66.7, depression ≥66.7, social function ≤50 and emotional function ≤58 on the EORTC linear transformed scale of 0-100 were significant predictors for poor treatment experience (p≤0.04) based on ROC analysis. On MVA poor BL social function was associated with reduced EOT HRQOL (β-9.3,_95%CI_-16.1_to_-2.6,_p<0.008), decreased physical function (β-24.4,_95%CI_-36.3_to_-12.6,_p<0.001), and high symptom burden_(β26.9,_95%CI_17.5_to_36.3,_p<0.001). Earlier disease stage predicted for decreased symptom burden_(β-6.7,_95%CI_-13.1_to_-0.3,_p=0.039). BL financial toxicity was a significant predictor on UVA (p=0.001-0.044) and showed a significant interaction term on MVA (p=0.024-0.041) for all three domains of poor treatment experience. Demographic and treatment-related factors were not predictive.

CONCLUSION: Cervical cancer patients with poor baseline social function or high financial toxicity were at-risk for increased symptom burden and poor HRQOL. Screening for these factors provides an opportunity for early intervention to improve treatment experience.

PMID:38825227 | DOI:10.1016/j.prro.2024.04.025

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Nevin Manimala Statistics

Air pollution, genetic factors, and chronic rhinosinusitis: A prospective study in the UK Biobank

Sci Total Environ. 2024 May 31:173526. doi: 10.1016/j.scitotenv.2024.173526. Online ahead of print.

ABSTRACT

BACKGROUND: Chronic rhinosinusitis (CRS) is a prevalent upper respiratory condition that manifests in two primary subtypes: CRS with nasal polyps (CRSwNP) and CRS without nasal polyps (CRSsNP). While previous studies indicate a correlation between air pollution and CRS, the role of genetic predisposition in this relationship remains largely unexplored. We hypothesized that higher air pollution exposure would lead to the development of CRS, and that genetic susceptibility might modify this association.

METHODS: This cohort study involving 367,298 adult participants from the UK Biobank, followed from March 2006 to October 2021. Air pollution metrics were estimated at residential locations using land-use regression models. Cox proportional hazard models were employed to explore the associations between air pollution exposure and CRS, CRSwNP, and CRSsNP. A polygenic risk score (PRS) was constructed to evaluate the joint effect of air pollution and genetic predisposition on the development of CRS.

RESULTS: We found that the risk of CRS increased under long-term exposure to PM2.5 [the hazard ratios (HRs) with 95 % CIs: 1.59 (1.26-2.01)], PM10 [1.64 (1.26-2.12)], NO2 [1.11 (1.04-1.17)], and NOx [1.18 (1.12-1.25)], respectively. These effects were more pronounced among participants with CRSwNP, although the differences were not statistically significant. Additionally, we found that the risks for CRS and CRSwNP increased in a graded manner among participants with higher PRS or higher exposure to PM2.5, PM10, or NOx concentrations. However, no multiplicative or additive interactions were observed.

CONCLUSIONS: Long-term exposure to air pollution increases the risk of CRS, particularly CRSwNP underscoring the need to prioritize clean air initiatives and environmental regulations.

PMID:38825199 | DOI:10.1016/j.scitotenv.2024.173526

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Nevin Manimala Statistics

Effect of topical vancomycin powder on surgical site infection prevention in major orthopaedic surgery: A systematic review and meta-analysis of randomised controlled trials with trial sequential analysis

J Hosp Infect. 2024 May 31:S0195-6701(24)00193-2. doi: 10.1016/j.jhin.2024.04.028. Online ahead of print.

ABSTRACT

BACKGROUND: Evidence were mixed regarding the effect of topical vancomycin (VCM) powder in reducing surgical site infection (SSI).

AIM: To clarify the effect of topical VCM powder for the prevention of in major orthopaedic surgeries.

METHODS: The MEDLINE, Embase, CENTRAL, ICTRP, and ClinicalTrials.gov databases were searched from their inception to 25 September 2023. We included randomised controlled trials comparing topical VCM powder and controls for the prevention of SSI in major orthopaedic surgeries. Two reviewers independently screened the title and abstract and extracted relevant data, followed by the assessment of the risk of bias and the certainty of the evidence. Main outcome measure were Overall SSI, reoperation, and adverse events. Summary results were obtained using random-effects meta-analysis. We performed trial sequential analysis (TSA).

FINDINGS: Eight randomised controlled trials provided data on 4,307 participants. VCM powder showed no difference in reducing overall SSI. The cumulative number of patients did not exceed the required information size of 19,233 in our TSA, and the Z-curves did not cross the trial sequential monitoring or futility boundary, suggesting an inconclusive result of the meta-analysis. No difference was found for reoperation. Among SSI, VCM powder showed statistically significant difference in reducing gram-positive cocci SSI. However, the certainty of this evidence was very low.

CONCLUSIONS: This systematic review and meta-analysis suggests inconclusive results regarding the effect of VCM powder in reducing SSI in major orthopaedic surgeries. Further trials using rigorous methodologies are required to elucidate the effect of this intervention.

PMID:38825190 | DOI:10.1016/j.jhin.2024.04.028

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Nevin Manimala Statistics

Machine learning models based on ultrasound and physical examination for airway assessment

Rev Esp Anestesiol Reanim (Engl Ed). 2024 May 31:S2341-1929(24)00101-X. doi: 10.1016/j.redare.2024.05.006. Online ahead of print.

ABSTRACT

PURPOSE: To demonstrate the utility of machine learning models for predicting difficult airways using clinical and ultrasound parameters.

METHODS: This is a prospective non-consecutive cohort of patients undergoing elective surgery. We collected as predictor variables age, sex, BMI, OSA, Mallampatti, thyromental distance, bite test, cervical circumference, cervical ultrasound measurements, and Cormack-Lehanne class after laryngoscopy. We univariate analyzed the relationship of the predictor variables with the Cormack-Lehanne class to design machine learning models by applying the random forest technique with each predictor variable separately and in combination. We found each design’s AUC-ROC, sensitivity, specificity, and positive and negative predictive values.

RESULTS: We recruited 400 patients. Cormack-Lehanne patients ≥ III had higher age, BMI, cervical circumference, Mallampati class membership ≥ III, and bite test ≥ II and their ultrasound measurements were significantly higher. Machine learning models based on physical examination obtained better AUC-ROC values than ultrasound measurements but without reaching statistical significance. The combination of physical variables that we call the “Classic Model” achieved the highest AUC-ROC value among all the models [0.75 (0.67-0.83)], this difference being statistically significant compared to the rest of the ultrasound models.

CONCLUSIONS: The use of machine learning models for diagnosing VAD is a real possibility, although it is still in a very preliminary stage of development.

CLINICAL REGISTRY: ClinicalTrials.gov: NCT04816435.

PMID:38825182 | DOI:10.1016/j.redare.2024.05.006

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Nevin Manimala Statistics

Unraveling the causal relationships between depression and brain structural imaging phenotypes: A bidirectional Mendelian Randomization study

Brain Res. 2024 May 31:149049. doi: 10.1016/j.brainres.2024.149049. Online ahead of print.

ABSTRACT

BACKGROUND: Previous studies have revealed structural brain abnormalities in individuals with depression, but the causal relationship between depression and brain structure remains unclear.

METHODS: A genetic correlation analysis was conducted using summary statistics from the largest genome-wide association studies for depression (N = 674,452) and 1,265 brain structural imaging-derived phenotypes (IDPs, N = 33,224). Subsequently, a bidirectional two-sample Mendelian Randomization (MR) approach was employed to explore the causal relationships between depression and the IDPs that showed genetic correlations with depression. The main MR results were obtained using the inverse variance weighted (IVW) method, and other MR methods were further employed to ensure the reliability of the findings.

RESULTS: Ninety structural IDPs were identified as being genetically correlated with depression and were included in the MR analyses. The IVW MR results indicated that reductions in the volume of several brain regions, including the bilateral subcallosal cortex, right medial orbitofrontal cortex, and right middle-posterior part of the cingulate cortex, were causally linked to an increased risk of depression. Additionally, decreases in surface area of the right middle temporal visual area, right middle temporal cortex, right inferior temporal cortex, and right middle-posterior part of the cingulate cortex were causally associated with a heightened risk of depression. Validation and sensitivity analyses supported the robustness of these findings. However, no evidence was found for a causal effect of depression on structural IDPs.

CONCLUSIONS: Our findings reveal the causal influence of specific brain structures on depression, providing evidence to consider brain structural changes in the etiology and treatment of depression.

PMID:38825161 | DOI:10.1016/j.brainres.2024.149049

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Evaluation of the therapeutic effects of Photodynamic Therapy in vulvar lichen sclerosus and impact on patient quality of life and sexual funtion

Photodiagnosis Photodyn Ther. 2024 May 31:104226. doi: 10.1016/j.pdpdt.2024.104226. Online ahead of print.

ABSTRACT

BACKGROUND: Vulvar lichen sclerosus (VLS) is often associated with irritable symptoms of itching, burning pain and can lead to scarring, architectural changes and sexual dysfunction as well as a decline in quality of life.The etiology of the disease is unknown. This study sought to assess the therapeutic effects of Photodynamic Therapy (PDT) in VLS, and improvment of patient quality of life and sexual funtion.

METHODS: From January 2022 to April 2023, a total of 65 patients with vulvar sclerosi (VLS) were treated with PDT in our hospital. All 65 patients were divided into two groups: early-stage group and late-stage group. The Cattaneo scoring method, the Dermatology Life Quality Index (DLQI) and the Female Sexual Function Index (FSFI) scores were used to evaluate the clinical effectiveness of the treatment on patients’ symptoms and clincal signs, quality of life as well as sexual function before and at 6-month after treatment.

RESULTS: The total effective rate of early-stage patients was significantly greater than that of late-stage patients at 6-month after PDT treatment (90.91% [40/44] vs 76.19% [16/21], p <0.05). At 6-month follow-up, the symptoms and clinical signs of patients in early-stage group were significantly improved compared with baseline, the average scores of itching, skin elasticity, whitening and lesion range were significantly lower than the scores before treatment (p <0.05). In late-stage group, The decrease in scores of itching, whitening and lesion range at the 6-months follow-up is significant(p <0.05), but skin elasticity (p=0.0625). On post-treatment follow-up examination, FSFI score was seen to have significantly improved in early-stage patients(from a median score of 17.45 to 21.1, p<0.05); DLQI also significantly improved after treatment (from a median score of 7 to 4, p<0.05). In late stage patients, The DLQI score improved significantly after treatment (from a median score of 18 to 15, p<0.05). However, the improvement in sexual function is not statistically significant (pre-treatment: median=10.55, post-treatment: median=10, p=0.1865).

CONCLUSION: Photodynamic therapy can effectively improve most symptoms and clinical signs, as well as quality of life of patients with VLS, especially for earlly stage patients. Moreover, improvement in sexual function is observed in early stage patients after PDT treatment. This study suggests that early and timely PDT treatment are recommended to achieve better results.

PMID:38825158 | DOI:10.1016/j.pdpdt.2024.104226