Category: Statistics

BMJ. 2024 Jul 3;386:q1462. doi: 10.1136/bmj.q1462.

NO ABSTRACT

PMID:38960617 | DOI:10.1136/bmj.q1462

Int J Spine Surg. 2024 Jul 3:8610. doi: 10.14444/8610. Online ahead of print.

ABSTRACT

BACKGROUND: Anterior cervical discectomy and fusion (ACDF) for the surgical treatment of cervical degenerative disease often includes an intervertebral cage, which restores disc height and lordosis while promoting fusion . Cage materials include titanium (TTN) or polyetheretherketone (PEEK). Controversy in material selection stems from higher fusion rates with TNN, despite a higher subsidence rate, while PEEK cages demonstrate superior preservation of interspace height. Combining the advantages of both materials, TTN-coated PEEK (TCPEEK) cages were developed, featuring a PEEK core with similar stiffness to the bone, enveloped with a TTN coat, improving osteointegration. However, the potential superiority of TCPEEK over TTN cages has not been investigated. This study aimed to compare clinical and radiographic outcomes following single- or double-level ACDF using either TTN or TCPEEK cages.

METHODS: This retrospective single-center study included patients undergoing single- or double-level ACDF between 2017 and 2019. Clinical outcomes included the Neck Disability Index and revision surgery incidence. Radiographic parameters included cervical and segmental lordosis, C2 to C7 sagittal vertical axis, fusion, subsidence, and adjacent segment degeneration at a minimum 12-month follow-up.

RESULTS: A total of 45 patients (16 TTN; 29 TCPEEK) and 58 cervical levels (21 TTN; 37 TCPEEK) were included. Both cages significantly improved Neck Disability Index scores (TTN -10.0; TCPEEK -14.1) without significant differences. Two single-level TCPEEK patients required revision surgery due to non-union. In the radiological assessments, no significant difference was found for subsidence rates (TTN 52.4%; TCPEEK 56.8%), adjacent segment degeneration, cervical and segmental lordosis, and changes in C2 to C7 sagittal vertical axis. Though not statistically significant, fusion rates trended slightly higher with TTN (90.5%) vs TCPEEK cages (86.5%).

CONCLUSION: TTN and TCPEEK cages achieve satisfactory clinical and radiological outcomes in single- or double-level ACDF. This finding suggests that the choice between them can be based on other factors, such as surgeon preference or availability, rather than specific material properties.

CLINICAL RELEVANCE: This study found that the selection of ACDF cage material did not affect clinical outcomes.

PMID:38960609 | DOI:10.14444/8610

BMJ. 2024 Jul 3;386:q1468. doi: 10.1136/bmj.q1468.

NO ABSTRACT

PMID:38960608 | DOI:10.1136/bmj.q1468

Psychooncology. 2024 Jul;33(7):e6369. doi: 10.1002/pon.6369.

ABSTRACT

OBJECTIVE: Prostate cancer can significantly impact mental wellbeing, creating uncertainty and morbidity. This study described patterns of psychotropic medication and mental health service use, as a proxy measure for mental health problems, 5 years before and 5 years after prostate cancer diagnosis.

METHODS: Population-based registry data were linked with Pharmaceutical Benefits Scheme and Medicare Benefits Schedule data for all prostate cancer patients diagnosed in South Australia between 2012 and 2020 (n = 13,693). We estimated the proportion and rates of psychotropic medication and mental health service use before and after diagnosis. Multivariable adjusted interrupted time series analyses (ITSA) were conducted to uncover temporal patterns.

RESULTS: Fifteen percent of men commenced psychotropic medications and 6.4% sought out mental health services for the first time after diagnosis. Psychotropic medication use rose from 34.5% 5 years before to 40.3% 5 years after diagnosis, including an increase in use of antidepressants (from 20.7% to 26.0%) and anxiolytics (from 11.3% to 12.8%). Mental health service use increased from 10.2% to 12.1%, with the increase mostly being general practice mental health visits (from 7.8% to 10.6%). Multivariable ITSA indicated a significant rise in medication and service utilisation immediately before and in the first 2 years following prostate cancer diagnosis.

CONCLUSION: There is a clear increase in psychotropic medication use and mental health service use around the time of prostate cancer diagnosis. Mental health outcomes of men with prostate cancer may be improved with early mental health screening, particularly during the diagnosis process, to enable early intervention.

PMID:38960607 | DOI:10.1002/pon.6369

BMJ. 2024 Jul 3;386:q1467. doi: 10.1136/bmj.q1467.

NO ABSTRACT

PMID:38960605 | DOI:10.1136/bmj.q1467

Sex Transm Infect. 2024 Jul 2:sextrans-2023-056100. doi: 10.1136/sextrans-2023-056100. Online ahead of print.

ABSTRACT

ObjectivesWe evaluated how storing vaginal samples at room temperature in stabilising solutions versus immediate freezing affects 16S rRNA gene amplicon sequencing-based microbiota studies, aiming to simplify home and field collection.

METHODS: Twenty participants self-collected six mid-vaginal swabs that were stored in two nucleic acid preservatives (three in modified Solution C2 (Qiagen) and three in Amies/RNALater (Sigma)) in January-February 2016. From each set, two were immediately frozen (-80°C) and one was shipped to the University of Idaho (Moscow, Idaho) with return shipping to the Institute for Genome Sciences (Baltimore, Maryland). Amplicon sequencing of the 16S rRNA gene was used to characterise the vaginal microbiota, VALENCIA was used to assign community state types (CSTs), and quantitative PCR (qPCR) of 16S rRNA genes was used to estimate bacterial abundance. Cohen’s Kappa statistic was used to assess within-participant agreement. Bayesian difference of means models assessed within-participant comparisons between shipped and immediately frozen samples.

RESULTS: There were 115 samples available for analysis. Average duration of transit for shipped samples was 8 days (SD: 1.60, range: 6-11). Within-participant comparisons of CSTs between shipped and immediately frozen samples revealed complete concordance (kappa: 1.0) for both preservative solutions. No significant differences comparing shipped and immediately frozen samples were found with taxon-level comparisons or bacterial abundances based on pan-bacterial qPCR.

CONCLUSIONS: Short-term room temperature shipping of vaginal swabs placed in stabilising solutions did not affect vaginal microbiota composition. Home collection with mail-in of vaginal samples may be a reasonable approach for research and clinical purposes to assess the vaginal microbiota.

PMID:38960602 | DOI:10.1136/sextrans-2023-056100

BMJ Support Palliat Care. 2024 Jul 2:spcare-2024-005024. doi: 10.1136/spcare-2024-005024. Online ahead of print.

ABSTRACT

OBJECTIVES: APOLLO study, ‘efficacy and safety of the deodorAnt Pad against Odour and uLceration for LOcally advanced breast cancer’, aimed to assess the safety and efficacy of wearing a deodorant pad in patients with locally advanced breast cancer (LABC) with an ulceration.

METHODS: Komagome Pads were previously developed by Juntendo University and Kao Corporation. In test A, a conventional pad consisting of gauze, a commercially available diaper, pad, etc and the Komagome Pad were compared over 3 days to assess their efficacy and possible improvements for short-term use. In test B, the Komagome Pad was used continuously for 1 month to evaluate its safety during long-term use.

RESULTS: This study included 14 patients in test A and nine in test B. In odour evaluation using sensory testing in test A, nine patients reported more significant efficacy in odour suppression with the Komagome Pad. The odour intensity of the Komagome Pad was lower on the gas chromatography-mass spectrometry. The group with a high level of exudation reported significantly higher satisfaction with the Komagome Pad. In test B, no adverse events were observed.

CONCLUSIONS: A new deodorant pad for LABC demonstrated high safety and deodorant efficacy.

PMID:38960599 | DOI:10.1136/spcare-2024-005024

Nurs Health Sci. 2024 Sep;26(3):e13136. doi: 10.1111/nhs.13136.

ABSTRACT

Postpartum depression is one of the most common mental health disorders in women after giving birth. This study was conducted to examine the effect of telecounseling support on depression in primiparous mothers. This study was conducted as a randomized controlled trial with a parallel group pretest-posttest design. The study comprised 50 participants each in the intervention and control groups. Face-to-face interviews were conducted with all participants, and the Maternal Information Form and the Edinburgh Postpartum Depression Scale (EPDS) were administered. The intervention group received telecounseling for 6 weeks, while the control group received routine postnatal care. After the 6-week period, EPDS was re-administered to both groups. In the intervention group, the EPDS mean score decreased from 7.12 ± 3.96 to 6.34 ± 3.73 after telecounseling (p < 0.001). Conversely, in the control group, the EPDS mean score increased from 6.62 ± 3.55 to 7.90 ± 4.65 without any intervention (p = 0.002). The results indicate that telecounseling is an effective method for reducing the risk of depression among mothers during the postpartum period. It is recommended that healthcare professionals extend their support by providing telecounseling for mothers.

PMID:38960587 | DOI:10.1111/nhs.13136

J Neurol Neurosurg Psychiatry. 2024 Jul 2:jnnp-2023-333296. doi: 10.1136/jnnp-2023-333296. Online ahead of print.

ABSTRACT

BACKGROUND: The pathogenesis of multiple sclerosis (MS) requires both genetic factors and environmental events. The question remains, however, whether these factors and events completely describe the MS disease process. This question was addressed using the Canadian MS data, which includes 29 478 individuals, estimated to represent 65-83% of all Canadian patients with MS.

METHOD: The ‘genetically-susceptible’ subset of the population, (G), includes everyone who has any non-zero life-time chance of developing MS, under some environmental conditions. A ‘sufficient’ environmental exposure, for any genetically-susceptible individual, includes every set of environmental conditions, each of which is ‘sufficient’, by itself, to cause MS in that person. This analysis incorporates many epidemiological parameters, involved in MS pathogenesis, only some of which are directly observable, and establishes ‘plausible’ value ranges for each parameter. Those parameter value combinations (ie, solutions) that fall within these plausible ranges are then determined.

RESULTS: Only a small proportion of the population (≤52%) has any possibility of developing MS, regardless of any environmental conditions that they could experience. Moreover, some of these genetically-susceptible individuals, despite their experiencing a ‘sufficient’ environmental exposure, will still not develop disease.

CONCLUSIONS: This analysis explicitly includes all of those genetic factors and environmental events (including their interactions), which are necessary for MS pathogenesis, regardless of whether these factors, events and interactions are known, suspected or as yet unrecognised. Nevertheless, in addition, a ‘truly’ random mechanism also seems to play a critical role in disease pathogenesis. This observation provides empirical evidence, which undermines the widely-held deterministic view of nature. Moreover, both sexes seem to share a similar genetic and environmental disease basis. If so, then it is this random mechanism, which is primarily responsible for the currently-observed differences in MS disease expression between susceptible women and susceptible men.

PMID:38960584 | DOI:10.1136/jnnp-2023-333296

Mayo Clin Proc. 2024 Jul;99(7):1058-1077. doi: 10.1016/j.mayocp.2023.11.023.

ABSTRACT

OBJECTIVE: To conduct a randomized controlled trial examining the effects of a social network intervention on health.

PARTICIPANTS AND METHODS: The Microclinic Social Network Program randomized controlled trial (implemented from June 1, 2011, through December 31, 2014) delivered weekly social-health classroom interventions for 9 to 10 months vs standard of care. Longitudinal multilevel analyses examined end-of-trial and 6-month post-intervention outcomes. Social network effects were estimated via a novel social induction ratio.

RESULTS: We randomized 494 participants, comprising 27 classroom clusters from five neighborhood cohorts. Compared with controls, the intervention showed decreased body weight ^–6.32 pounds (95% CI, ^–8.65 to ^–3.98; overall P<.001), waist circumference ^–1.21 inches (95% CI, ^–1.84 to ^–0.58; overall P<.001), hemoglobin A_1c % change ^–1.60 (95% CI, ^–1.88 to ^–1.33; overall P<.001), mean arterial blood pressure ^–1.83 mm Hg (95% CI, ^–3.79 to 0.32; overall P<.01), borderline-increased high-density lipoprotein cholesterol 1.09 (95% CI, 0.01-2.17; P=.05; overall P=.01). At 6 months post-intervention, net improvements were: weight change 97% sustained (P<.001), waist circumference change 92% sustained (P<.001), hemoglobin A_1c change 82.5% sustained (P<.001), high-density lipoprotein change 79% sustained (overall P=.01), and mean arterial blood pressure change greater than 100% sustained improvement of ^–4.21 mm Hg (P<.001). Mediation analysis found that diet and exercise did not substantially explain improvements. In the intent-to-treat analysis of social causal induction, the weight-change social induction ratio (SIR) was 1.80 for social-network weight change-meaning that social networks explained the greater weight loss in the intervention than controls. Furthermore, we observed an even stronger weight-loss SIR of 2.83 at 6 months post-intervention.

CONCLUSION: Results show intervention effectiveness for improving health in resource-limited communities, with SIR demonstrating that social-network effects helped induce such improvements.

TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT01651065.

PMID:38960495 | DOI:10.1016/j.mayocp.2023.11.023