Tag: statistics

Neurosurg Rev. 2023 Aug 30;46(1):215. doi: 10.1007/s10143-023-02121-1.

ABSTRACT

Although typically benign, trigeminal schwannomas (TS) may require surgical resection when large or symptomatic and can cause significant morbidity. This study aims to summarize the literature and synthesize outcomes following surgical resection of TS. A systematic review was performed according to PRISMA guidelines. Data extracted included patient and tumor characteristics, surgical approaches, and postoperative outcomes. Odds ratios (OR) with corresponding 95% confidence intervals (CI) were used for outcome analysis. The initial search yielded 1838 results, of which 26 studies with 974 patients undergoing surgical resection of TS were included. The mean age was 42.9 years and 58.0% were female. The mean tumor diameter was 4.7 cm, with Samii type A, B, C, and D tumors corresponding to 33.4%, 15.8%, 37.2%, and 13.6%, respectively. Over a mean symptom duration of 29 months, patients presented with trigeminal hypesthesia (58.7%), headache (32.8%), trigeminal motor weakness (22.8%), facial pain (21.3%), ataxia (19.4%), diplopia (18.7%), and visual impairment (12.0%). Surgical approaches included supratentorial (61.4%), infratentorial (15.0%), endoscopic (8.6%), combined/staged (5.3%), and anterior (5.7%) or posterior (4.0%) petrosectomy. Postoperative improvement of facial pain (83.9%) was significantly greater than trigeminal motor weakness (33.0%) or hypesthesia (29.4%). The extent of resection (EOR) was reported as gross total (GTR), near total, and subtotal in 77.7%, 7.7%, and 14.6% of cases, respectively. Over a mean follow-up time of 62.6 months, recurrence/progression was noted in 7.4% of patients at a mean time to recurrence of 44.9 months. Patients with GTR had statistically significantly lower odds of recurrence/progression (OR: 0.07; 95% CI: 0.04-0.15) compared to patients with non-GTR. This systematic review and meta-analysis report patient outcomes following surgical resection of TS. EOR was found to be an important predictor of the risk of recurrence. Facial pain was more likely to improve postoperatively than facial hypesthesia. This work reports baseline rates of post-operative complications across studies, establishing benchmarks for neurosurgeons innovating and working to improve surgical outcomes for TS patients.

PMID:37646878 | DOI:10.1007/s10143-023-02121-1

Eur J Orthop Surg Traumatol. 2023 Aug 30. doi: 10.1007/s00590-023-03700-0. Online ahead of print.

ABSTRACT

PURPOSE: The complex anatomy of acetabular fracture needs a surgical approach that can achieve anatomical reduction with fewer complications for the fixation of these fractures. Current literature suggests that both Pararectus (PR) approach and Ilioinguinal (IL) approach can be used for the fixation of these fractures safely. However, superiority of the PR approach over the IL approach is not established. Hence, this meta-analysis aimed to compare the PR versus IL approach.

METHODOLOGY: A literature search was performed on five databases Medline/PubMed, Scopus Embase, Cinhal, and Cochrane Library, from the inception to January 14, 2023. A qualitative and quantitative analysis was done for the five eligible studies from the literature search. Individual study characteristics data and outcomes were extracted, and Software version 5.4.1 of Review Manager was used for statistical analysis.

RESULTS: Five articles, one Randomized trial (RCT), and four retrospective articles were included and analyzed in this meta-analysis. PR approach has a shorter surgical time [mean difference (MD) -48.4 with 95% CI -74.49, -22.30; p = 0.0003], less intraoperative blood loss (MD -123.22 with 95% CI -212.28, -34.15; p = 0.007), and smaller surgical incision (MD -9.87 with 95% CI -15.21, -4.52; p = 0.0003) than the IL approach. However, the meta-analysis failed to show a difference between the two surgical approaches concerning the quality of reduction, overall complications, nerve injury, vascular injury, heterotopic ossification, deep vein thrombosis, and pulmonary embolism.

CONCLUSION: The PR approach has a shorter surgical duration, less blood loss, and a smaller surgical incision than the IL approach. However, both surgical approaches have equivocal results regarding fracture reduction quality, complication rates, and functional outcomes for acetabular fracture fixation. Hence, for acetabular fractures fixation, PR approach can be considered a safe and feasible alternative to the IL approach.

PMID:37646876 | DOI:10.1007/s00590-023-03700-0

J Am Heart Assoc. 2023 Aug 30:e030506. doi: 10.1161/JAHA.122.030506. Online ahead of print.

ABSTRACT

Background Racially and ethnically minoritized groups, people with lower income, and rural communities have worse access to percutaneous coronary intervention (PCI) than their counterparts, but PCI hospitals have preferentially opened in wealthier areas. Our study analyzed disparities in PCI access, treatment, and outcomes for patients with acute myocardial infarction based on the census-derived Area Deprivation Index. Methods and Results We obtained patient-level data on 629 419 patients with acute myocardial infarction in California between January 1, 2006 and December 31, 2020. We linked patient data with population characteristics and geographic coordinates, and categorized communities into 5 groups based on the share of the population in low or high Area Deprivation Index neighborhoods to identify differences in PCI access, treatment, and outcomes based on community status. Risk-adjusted models showed that patients in the most advantaged communities had 20% and 15% greater likelihoods of receiving same-day PCI and PCI during the hospitalization, respectively, compared with patients in the most disadvantaged communities. Patients in the most advantaged communities also had 19% and 16% lower 30-day and 1-year mortality rates, respectively, compared with the most disadvantaged, and a 15% lower 30-day readmission rate. No statistically significant differences in admission to a PCI hospital were observed between communities. Conclusions Patients in disadvantaged communities had lower chances of receiving timely PCI and a greater risk of mortality and readmission compared with those in more advantaged communities. These findings suggest a need for targeted interventions to influence where cardiac services exist and who has access to them.

PMID:37646213 | DOI:10.1161/JAHA.122.030506

Diabetes Obes Metab. 2023 Aug 30. doi: 10.1111/dom.15248. Online ahead of print.

ABSTRACT

BACKGROUND: Donor hyperglycaemia following brain death has been attributed to reversible insulin resistance. However, our islet and pancreas transplant data suggest that other mechanisms may be predominant. We aimed to determine the relationships between donor insulin use and markers of beta-cell death and beta-cell function in pancreas donors after brain death.

METHODS: In pancreas donors after brain death, we compared clinical and biochemical data in ‘insulin-treated’ and ‘not insulin-treated donors’ (IT vs. not-IT). We measured plasma glucose, C-peptide and levels of circulating unmethylated insulin gene promoter cell-free DNA (INS-cfDNA) and microRNA-375 (miR-375), as measures of beta-cell death. Relationships between markers of beta-cell death and islet isolation outcomes and post-transplant function were also evaluated.

RESULTS: Of 92 pancreas donors, 40 (43%) required insulin. Glycaemic control and beta-cell function were significantly poorer in IT donors versus not-IT donors [median (IQR) peak glucose: 8 (7-11) vs. 6 (6-8) mmol/L, p = .016; C-peptide: 3280 (3159-3386) vs. 3195 (2868-3386) pmol/L, p = .046]. IT donors had significantly higher levels of INS-cfDNA [35 (18-52) vs. 30 (8-51) copies/ml, p = .035] and miR-375 [1.050 (0.19-1.95) vs. 0.73 (0.32-1.10) copies/nl, p = .05]. Circulating donor miR-375 was highly predictive of recipient islet graft failure at 3 months [adjusted receiver operator curve (SE) = 0.813 (0.149)].

CONCLUSIONS: In pancreas donors, hyperglycaemia requiring IT is strongly associated with beta-cell death. This provides an explanation for the relationship of donor IT with post-transplant beta-cell dysfunction in transplant recipients.

PMID:37646197 | DOI:10.1111/dom.15248

Psychiatry Clin Neurosci. 2023 Aug 30. doi: 10.1111/pcn.13593. Online ahead of print.

ABSTRACT

AIM: The present study examined the microbiome abundance and composition of drug-naïve or drug-free patients with obsessive-compulsive disorder (OCD) compared to healthy controls. In addition, in the OCD group, the microbiome composition was compared between early-onset and late-onset OCD.

METHODS: Serum samples were collected from 89 patients with OCD and 107 age- and sex-matched healthy controls. Bacterial DNA was isolated from bacteria-derived extracellular vesicles in serum and then amplified and quantified using primers specific to the V3-V4 hypervariable region of the 16S rDNA gene. The 16S rRNA gene amplicon sequencing was performed.

RESULTS: The pooled estimate showed that alpha diversity was significantly reduced in patients with OCD compared to that in healthy controls (p_Shannon = 0.00015). In addition, a statistically significant difference was observed in beta diversity between patients with OCD and healthy controls at the order (p = 0.012), family (p = 0.003), genus (p < 0.001), and species (p = 0.005) levels. In the microbiome composition, Pseudomonas, Caulobacteraceae(f), Streptococcus, Novosphingobium, and Enhydrobacter at the genus level were significantly less prevalent in patients with OCD than in controls. In addition, among patients with OCD, the microbial composition in the early-onset versus late-onset types was significantly different with respect to the genera Corynebacterium and Pelomonas.

CONCLUSION: The present study showed an aberrant microbiome in patients with OCD, suggesting a role of the microbiota-brain interaction in the pathophysiology of OCD. Further longitudinal studies with larger sample sizes adjusting for various confounders are warranted. This article is protected by copyright. All rights reserved.

PMID:37646189 | DOI:10.1111/pcn.13593

Med Care Res Rev. 2023 Aug 30:10775587231194658. doi: 10.1177/10775587231194658. Online ahead of print.

ABSTRACT

We conducted a secondary analysis of the evaluations of 22 sites participating in four primary care redesign initiatives funded by the Centers for Medicare and Medicaid Services or the Center for Medicare and Medicaid Innovation. Our objectives were to determine the overall impact of the initiatives on Medicare expenditures and whether specific site-level program features influenced expenditure findings. Averaged over sites, the mean intervention effect was a statistically insignificant US$26 per beneficiary per year. Policy implications from meta-regression results suggest that funders should consider supporting technical assistance efforts and pay for performance incentives to increase savings. There was no evidence that paying for medical home transformation produced savings in total cost of care. We estimate that in future evaluations, data from 35 sites would be needed to detect feature effects of US$300 per beneficiary per year.

PMID:37646166 | DOI:10.1177/10775587231194658

Acta Oncol. 2023 Aug 30:1-10. doi: 10.1080/0284186X.2023.2249225. Online ahead of print.

ABSTRACT

PURPOSE: Triplet chemotherapy might be more effective than doublet chemotherapy in metastatic colorectal cancer (mCRC), but it may also be marked by increased toxicity. To investigate whether δ-tocotrienol, a vitamin E analogue, with possible neuroprotective and anti-inflammatory effects, reduces the toxicity of triplet chemotherapy, we conducted a randomized, double-blind, placebo-controlled trial in mCRC patients receiving first-line 5-fluorouracil, oxaliplatin and irinotecan (FOLFOXIRI).

MATERIAL AND METHODS: Seventy patients with mCRC were randomly assigned (1:1) to receive FOLFOXIRI plus either δ-tocotrienol or placebo at the Department of Oncology, Vejle Hospital, Denmark. Eligibility criteria were adenocarcinoma in the colon or rectum, age 18-75 years and ECOG performance status 0-1. FOLFOXIRI was given in eight cycles followed by four cycles of 5-fluorouracil. δ-tocotrienol 300 mg or placebo × 3 daily was added during chemotherapy and for a maximum of two years. The primary endpoint was time to hospitalization or death during treatment with chemotherapy.

RESULTS: Median time to first hospitalization or death was 3.7 months in the placebo group (95% CI 1.93-not reached (NR)), and was NR in the δ-tocotrienol group (95% CI 1.87-NR) with a hazard ratio of 0.70 (95% CI 0.36-1.36). Grade 3-4 toxicities were uncommon in both groups, except for neutropenia, which occurred in 19 patients (58%) in the placebo group and 17 patients (50%) in the δ-tocotrienol group. There were no grade 3 or 4 peripheral sensory neuropathy. In the placebo group, 24 patients (71%) had oxaliplatin dose reductions compared to 17 patients (47%) in the δ-tocotrienol group (p = 0.047).

CONCLUSION: The addition of δ-tocotrienol to FOLFOXIRI did not statistically significant prolong the time to first hospitalization or death compared to FOLFOXIRI plus placebo. Toxicity was manageable and not statistically different. There was a statistically significant difference in dose reductions of oxaliplatin pointing to a possible neuroprotective effect of δ-tocotrienol.

PMID:37646150 | DOI:10.1080/0284186X.2023.2249225

Schweiz Arch Tierheilkd. 2023 Sep;165(9):573-584. doi: 10.17236/sat00402.

ABSTRACT

This study aimed to describe equine transportation practices and transport-related behavioural and health problems in Switzerland and to identify possible associations between them. An online survey was disseminated to Swiss equine industry members and questioned respondents’ details, transport practices (before, during, and after journeys), horse transport-related behavioural (TRPBs) and health problems (TRHPs) experienced in the previous 2 years. The survey generated 441 valid responses, analysed using descriptive statistics and logistic regression models (outcomes: TRPBs, TRHPs, injuries, diarrhea). Respondents were mainly women (79,5 %), younger than 50 years (75 %), and amateurs (80 %). Most of the respondents transported one or two horses (88,7 %), for a short (< 2 hours) journey (75,5 %). Pre-transport practices were performed by 72,1 % of respondents and horses’ fitness for travel was assessed in the majority of cases (66,5 %). During the journey, horses were tethered (92,6 %) and monitored (52,7 %). The majority of respondents (74,9 %) assessed also the horses’ fitness after travel. TRPBs were reported by 13,4 % of respondents. TRPBs’ likelihood increased when the respondents were women, performed pre-transport practices and training for transport, did not assess drinking behaviour and general health before journey, and the horses experienced also TRHPs. TRHPs were reported by 34 % of the respondents and were associated with younger respondents, use of trucks, doing pre-transport practices, wearing protections, not monitoring horses during transport and preexisting TRPBs. Among TRHPs the most frequent were injuries (72,1 %) and diarrhea (41 %). The likelihood of injuries increased with younger respondents, use of trucks, wearing protections, lack of monitoring during transport and TRPBs. While younger respondents, longer journeys, wearing protections, lack of monitoring during transport, measuring rectal temperature after journeys and TRPBs increased the odds of reporting diarrhea. Even though our findings must be interpreted with caution due to survey limitations, considering that the found associations do not always mean causation, they highlight the strengths and weaknesses of transport practices in Switzerland and report evidence to implement current regulations on the protection of horse welfare during transport.

PMID:37646097 | DOI:10.17236/sat00402

Hum Reprod. 2023 Aug 29:dead173. doi: 10.1093/humrep/dead173. Online ahead of print.

ABSTRACT

STUDY QUESTION: Does assisted hatching increase the cumulative live birth rate in subfertile couples with repeated implantation failure?

SUMMARY ANSWER: This study showed no evidence of effect for assisted hatching as an add-on in subfertile couples with repeated implantation failure.

WHAT IS KNOWN ALREADY: The efficacy of assisted hatching, with regard to the live birth rate has not been convincingly demonstrated in randomized trials nor meta-analyses. It is suggested though that especially poor prognosis women, e.g. women with repeated implantation failure, might benefit most from assisted hatching.

STUDY DESIGN, SIZE, DURATION: The study was designed as a double-blinded, multicentre randomized controlled superiority trial. In order to demonstrate a statistically significant absolute increase in live birth rate of 10% after assisted hatching, 294 participants needed to be included per treatment arm, being a total of 588 subfertile couples. Participants were included and randomized from November 2012 until November 2017, 297 were allocated to the assisted hatching arm of the study and 295 to the control arm. Block randomization in blocks of 20 participants was applied and randomization was concealed from participants, treating physicians, and laboratory staff involved in the embryo transfer procedure. Ovarian hyperstimulation, oocyte retrieval, laboratory procedures, embryo selection for transfer and cryopreservation, the transfer itself, and luteal support were performed according to local protocols and were identical in both the intervention and control arm of the study with the exception of the assisted hatching procedure which was only performed in the intervention group. The laboratory staff performing the assisted hatching procedure was not involved in the embryo transfer itself.

PARTICIPANTS/MATERIALS, SETTING, METHODS: Participants were eligible for inclusion in the study after having had either at least two consecutive fresh IVF or ICSI embryo transfers, including the transfer of frozen and thawed embryos originating from those fresh cycles, and which did not result in a pregnancy or as having had at least one fresh IVF or ICSI transfer and at least two frozen embryo transfers with embryos originating from that fresh cycle which did not result in a pregnancy. The study was performed at the laboratory sites of three tertiary referral hospitals and two university medical centres in the Netherlands.

MAIN RESULTS AND THE ROLE OF CHANCE: The cumulative live birth rate per started cycle, including the transfer of fresh and subsequent frozen/thawed embryos if applicable, resulted in 77 live births in the assisted hatching group (n = 297, 25.9%) and 68 live births in the control group (n = 295, 23.1%). This proved to be statistically not significantly different (relative risk: 1.125, 95% CI: 0.847 to 1.494, P = 0.416).

LIMITATIONS, REASONS FOR CAUTION: There was a small cohort of subfertile couples that after not achieving an ongoing pregnancy, still had cryopreserved embryos in storage at the endpoint of the trial, i.e. 1 year after the last randomization. It cannot be excluded that the future transfer of these frozen/thawed embryos increases the cumulative live birth rate in either or both study arms. Next, at the start of this study, there was no international consensus on the definition of repeated implantation failure. Therefore, it cannot be excluded that assisted hatching might be effective in higher order repeated implantation failures.

WIDER IMPLICATIONS OF THE FINDINGS: This study demonstrated no evidence of a statistically significant effect for assisted hatching by increasing live birth rates in subfertile couples with repeated implantation failure, i.e. the couples which, based on meta-analyses, are suggested to benefit most from assisted hatching. It is therefore suggested that assisted hatching should only be offered if information on the absence of evidence of effect is provided, at no extra costs and preferably only in the setting of a clinical trial taking cost-effectiveness into account.

STUDY FUNDING/COMPETING INTEREST(S): None.

TRIAL REGISTRATION NUMBER: Netherlands Trial Register (NTR 3387, NL 3235, https://www.clinicaltrialregister.nl/nl/trial/26138).

TRIAL REGISTRATION DATE: 6 April 2012.

DATE OF FIRST PATIENT’S ENROLMENT: 28 November 2012.

PMID:37646072 | DOI:10.1093/humrep/dead173

Neurol Clin Pract. 2023 Oct;13(5):e200180. doi: 10.1212/CPJ.0000000000200180. Epub 2023 Aug 28.

ABSTRACT

BACKGROUND AND OBJECTIVES: To develop a valid, disease-specific, patient-reported outcome (PRO) measure for adolescents and adults with Friedreich ataxia (FA) for use in therapeutic trials.

METHODS: We conducted semistructured qualitative interviews and a national cross-sectional study of individuals with FA to determine the most prevalent and burdensome symptoms and symptomatic themes to this population. These symptoms and symptomatic themes were included as questions in the first version of the Friedreich’s Ataxia-Health Index (FA-HI). We subsequently used factor analysis, beta interviews with 17 individuals with FA, and test-retest reliability assessments with 20 individuals with FA to evaluate, refine, and optimize the FA-HI. Finally, we determined the capability of the FA-HI to differentiate between subgroups of FA participants with varying levels of disease severity.

RESULTS: Participants with FA identified 18 symptomatic themes of importance to be included as subscales in the FA-HI. The FA-HI demonstrates high internal consistency and test-retest reliability, and it was identified by participants as highly relevant, comprehensive, and easy to complete. FA-HI total and subscale scores statistically differentiated between subgroups of participants with varying levels of disease burden.

DISCUSSION: Initial evaluation of the FA-HI supports its validity and reliability as a PRO for assessing how individuals with FA feel and function.

PMID:37646046 | PMC:PMC10462051 | DOI:10.1212/CPJ.0000000000200180