Tag: statistics

Lasers Med Sci. 2023 Apr 20;38(1):108. doi: 10.1007/s10103-023-03764-8.

ABSTRACT

The association between intravascular photobiomodulation (iPBM) and crossed cerebellar diaschisis (CCD) and cognitive dysfunction in patients with traumatic brain injury (TBI) remains unknown. We postulate that iPBM might enable greater neurologic improvements. The objective of this study was to evaluate the clinical impact of iPBM on the prognosis of patients with TBI. In this longitudinal study, patients who were diagnosed with TBI were recruited. CCD was identified from brain perfusion images when the uptake difference of both cerebella was > 20%. Thus, two groups were identified: CCD( +) and CCD( -). All patients received general traditional physical therapy and three courses of iPBM (helium-neon laser illuminator, 632.8 nm). Treatment assemblies were conducted on weekdays for 2 consecutive weeks as a solitary treatment course. Three courses of iPBM were performed over 2-3 months, with 1-3 weeks of rest between each course. The outcomes were measured using the Rancho Los Amigos Levels of Cognitive Functioning (LCF) tool. The chi-square test was used to compare categorical variables. Generalized estimating equations were used to verify the associations of various effects between the two groups. p < 0.05 indicated a statistically significant difference. Thirty patients were included and classified into the CCD( +) and CCD( -) groups (n = 15, each group). Statistics showed that before iPBM, CCD in the CCD( +) group was 2.74 (exp 1.0081) times higher than that of CCD( -) group (p = 0.1632). After iPBM, the CCD was 0.64 (exp-0.4436) times lower in the CCD( +) group than in the CCD( -) group (p < 0.0001). Cognitive assessment revealed that, before iPBM, the CCD( +) group had a non-significantly 0.1030 lower LCF score than that of CCD( -) group (p = 0.1632). Similarly, the CCD( +) group had a non-significantly 0.0013 higher score than that of CCD( -) after iPBM treatment (p = 0.7041), indicating no significant differences between the CCD( +) or CCD( -) following iPBM and general physical therapy. CCD was less likely to appear in iPBM-treated patients. Additionally, iPBM was not associated with LCF score. Administration of iPBM could be applied in TBI patients to reduce the occurrence of CCD. The study failed to show differences in cognitive function after iPBM, which still serves as an alternative non-pharmacological intervention.

PMID:37076743 | DOI:10.1007/s10103-023-03764-8

Int Ophthalmol. 2023 Apr 20. doi: 10.1007/s10792-023-02719-w. Online ahead of print.

ABSTRACT

PURPOSE: The treatment options for canalicular obstruction remain controversial, and there are different approaches. In this study, we aimed to evaluate the success of balloon dilatation and silicon tube intubation according to the etiology in patients with canalicular obstruction.

METHODS: The files of 91 patients with isolated monocanalicular obstruction were retrospectively reviewed. Patients were grouped according to surgical methods (Group A: both balloon dilatation and silicon tube intubation; Group B: Only balloon dilatation) and etiologies (topical anti-glaucomatous usage-related, inflammatory, chemotherapy-related, radiotherapy-related, trauma-related, idiopathic). Preoperative and postoperative Munk scores and lacrimal irrigation results were noted in all cases.

RESULTS: Munk score was found to be statistically significantly lower in the 1st year in both groups. The patency rate with lacrimal syringing was found to be statistically significantly higher in group A. Success rates both in the munk score and lacrimal passage patency were found to be statistically significantly lower in inflammatory etiology than other etiologies.

CONCLUSIONS: Both techniques can be used as first-line therapies for canalicular obstruction. It should be considered that recurrence may develop in stenosis of inflammatory origin and more invasive surgery may be required.

PMID:37076655 | DOI:10.1007/s10792-023-02719-w

Pflugers Arch. 2023 Apr 20. doi: 10.1007/s00424-023-02811-1. Online ahead of print.

ABSTRACT

Non-hypotensive hypovolemia simulated with oscillatory lower body negative pressure in the range of -10 to -20 mmHg is associated with vasoconstriction {increase in total peripheral vascular resistance (TPVR)}. Due to the mechanical stiffening of vessels, there is a disjuncture of mechano-neural coupling at the level of arterial baroreceptors which has not been investigated. The study was designed to quantify both the cardiac and vascular arms of the baroreflex using an approach based on Wiener-Granger causality (WGC) – partial directed coherence (PDC). Thirty-three healthy human volunteers were recruited and continuous heart rate and blood pressure {systolic (SBP), diastolic (DBP), and mean (MBP)} were recorded. The measurements were taken in resting state, at -10 mmHg (level 1) and -15 mmHg (level 2). Spectral causality – PDC was estimated from the MVAR model in the low-frequency band using the GMAC MatLab toolbox. PDC from SBP and MBP to RR interval and TPVR was calculated. The PDC from MBP to RR interval showed no significant change at -10 mmHg and -15 mmHg. No significant change in PDC from MBP to TPVR at -10 mmHg and -15 mmHg was observed. Similar results were obtained for PDC estimation using SBP as input. However, a significant increase in TPVR from baseline at both levels of oscillatory LBNP (p-value <0.001). No statistically significant change in PDC from blood pressure to RR interval and blood pressure to TPVR implies that vasoconstriction is not associated with activation of the arterial baroreflex in ≤-15 mmHg LBNP. Thereby, indicating the role of cardiopulmonary reflexes during the low level of LBNP simulated non-hypotensive hypovolemia.

PMID:37076560 | DOI:10.1007/s00424-023-02811-1

J Acupunct Meridian Stud. 2023 Apr 30;16(2):70-78. doi: 10.51507/j.jams.2023.16.2.70.

ABSTRACT

BACKGROUND: Adhesive capsulitis is a progressive, idiopathic disorder that significantly impacts individuals̓ daily lives and increases their medical burden. Pharmacopuncture therapy, which combines acupuncture techniques with herbal medicine, involves injecting herbal extracts into specific acupoints. This study aims to determine the effectiveness and safety of pharmacopuncture therapy in comparison to physiotherapy (PT) for treating adhesive capsulitis.

METHODS: This research protocol outlines a two-arm, parallel, multi-center, pragmatic randomized controlled trial. Fifty participants will be randomly allocated to either the pharmacopuncture therapy or PT group, and they will receive 12 sessions of their respective therapies over a 6-week period. The primary outcome measure is the numeric rating scale for shoulder pain. Secondary outcomes include the visual analog scale score for shoulder pain, Shoulder Pain and Disability Index, Patients̓ Global Impression of Change score, Short Form-12 Health Survey Version 2 score, and EuroQol-5 Dimension. Statistical analysis will be conducted based on the intention-to-treat principle.

DISCUSSION: This trial may offer high-quality and reliable clinical evidence for evaluating the effectiveness and safety of pharmacopuncture therapy compared to PT in the treatment of adhesive capsulitis. Furthermore, this study will serve as a valuable guideline for practitioners when making clinical decisions and managing adhesive capsulitis.

PMID:37076182 | DOI:10.51507/j.jams.2023.16.2.70

J Acupunct Meridian Stud. 2023 Apr 30;16(2):56-64. doi: 10.51507/j.jams.2023.16.2.56.

ABSTRACT

BACKGROUND: Pain related to Temporomandibular Disorders (TMD) is severe, negatively affecting patients’ quality of life, and often resistant to conventional treatments. Abdominal Acupuncture (AA) is known to be particularly effective for pain, especially chronic and musculoskeletal pain, but it is still poorly studied and never investigated in TMD patients.

OBJECTIVES: To analyze the efficacy of AA for the treatment of patients with subacute and chronic pain related to TMD and non-responding to previous conventional therapies (occlusal splint, medications, physical therapy).

METHODS: Twenty-eight patients, 24 F and four M (mean age 49.36 years), were recruited from January 2019-February 2021. All patients underwent AA treatment: two sessions per week for four weeks, for a total of eight sessions. At the beginning of therapy (T0) and at the end of the cycle (T1) the following data were evaluated: maximum mouth opening (MMO); cranio-facial pain related to TMD (verbal numeric scale, VNS); pain interference with normal activities and quality of life of patients (Brief Pain Inventory, BPI); oral functioning (Oral Behavior Checklist, OBC); impression of treatment effectiveness (Patients’ Global Impression of Improvement, PGI-I Scale). Statistical comparison of data before and after the AA treatment was performed by Wilcoxon’s signed-rank test (significance level p < 0.05).

RESULTS: The MMO values were significantly improved after one cycle of AA (p = 0.0002). In addition, TMD-related pain had a statistically significant decline following AA treatment (all p < 0.001). Patients’ general activity and quality of life (BPI) were described as improved following a course of AA, with statistically significant values for all aspects considered (all p < 0.05).

CONCLUSION: Abdominal acupuncture resulted in effective treatment of subacute/chronic-resistant pain related to TMD, capable of improving mandibular function and facial pain, and reduced the interference of pain affecting patients’ quality of life.

PMID:37076180 | DOI:10.51507/j.jams.2023.16.2.56

Int J Spine Surg. 2023 Apr 19:8470. doi: 10.14444/8470. Online ahead of print.

ABSTRACT

BACKGROUND: The objective of this study was to assess the pullout force of a novel sharp-tipped screw developed for single-step, minimally invasive pedicle screw placement guided by neuronavigation compared with the pullout force for traditional screws.

METHODS: A total of 60 human cadaveric lumbar pedicles were studied. Three different screw insertion techniques were compared: (A) Jamshidi needle and Kirschner wire without tapping; (B) Jamshidi needle and Kirschner wire with tapping; and (C) sharp-tipped screw insertion. Pullout tests were performed at a displacement rate of 10 mm/min recorded at 20 Hz. Mean values of these parameters were compared using paired t tests (left vs right in the same specimen): A vs B, A vs C, and B vs C. Additionally, 3 L1-L5 spine models were used for timing each screw insertion technique for a total of 10 screw insertions for each technique. Insertion times were compared using 1-way analysis of variance.

RESULTS: The mean pullout force for insertion technique A was 1462.3 (597.5) N; for technique B, it was 1693.5 (805.0) N; and for technique C, it was 1319.0 (735.7) N. There was no statistically significant difference in pullout force between techniques (P > 0.08). The average insertion time for condition C was significantly less than that for conditions A and B (P < 0.001).

CONCLUSIONS: The pullout force of the novel sharp-tipped screw placement technique is equivalent to that of traditional techniques. The sharp-tipped screw placement technique appears biomechanically viable and has the advantage of saving time during insertion.

CLINICAL RELEVANCE: Single-step screw placement using high resolution 3-dimensional navigation has the potential to streamline workflow and reduce operative time.

PMID:37076254 | DOI:10.14444/8470

Reg Anesth Pain Med. 2023 Apr 19:rapm-2023-104547. doi: 10.1136/rapm-2023-104547. Online ahead of print.

ABSTRACT

Liposomal bupivacaine has been the topic of intense academic debate over the past years culminating in an industry-initiated libel lawsuit against the American Society of Anesthesiologists and various other defendants. In this Daring Discourse, we first aim to provide a general overview of main themes in the ongoing controversy: (1) between-study heterogeneity, (2) the high number of negative high-quality reviews and meta-analyses, (3) publication bias in the context of an active role of industry and (4) difference between statistical and clinical significance. We then discuss the contents of the lawsuit, its potential implications and what the recent resolution of this lawsuit means for the future of research and the academic discourse on liposomal bupivacaine.

PMID:37076253 | DOI:10.1136/rapm-2023-104547

Reg Anesth Pain Med. 2023 Apr 19:rapm-2022-104110. doi: 10.1136/rapm-2022-104110. Online ahead of print.

ABSTRACT

INTRODUCTION: Surgical site infiltration with bupivacaine hydrochloride (HCl) is a standard element of postoperative analgesia for soft tissue surgeries, but results in short-lived analgesia. A novel bupivacaine implant, XARACOLL (bupivacaine HCl), is Food and Drug Administration approved for treatment of acute postsurgical pain following adult inguinal herniorrhaphy. This study examined the efficacy and safety of the bupivacaine implant (300 mg) compared with placebo for postsurgical pain after abdominoplasty.

METHODS: In this double-blind, placebo-controlled study, patients undergoing abdominoplasty were randomized to three 100 mg bupivacaine implants or three placebo collagen implants, in a 1:1 ratio, implanted intraoperatively. No other analgesics were administered into the surgical site. Patients were allowed opioids and acetaminophen for postoperative pain. Patients were followed for up to 30 days after treatment.

PRIMARY OUTCOME: the analgesic effect of the bupivacaine implants through 24 hours postsurgery, measured by the sum of time-weighted pain intensity (SPI24). Prespecified key secondary outcomes included SPI48 and SPI72, percentage of opioid-free patients through 24, 48, and 72 hours, and adverse events, which were tested sequentially to control for multiplicity (ie, if the first variable failed to reach significance, no subsequent variables were declared statistically significant).

RESULTS: The bupivacaine implant patients (n=181) reported statistically significant lower SPI24 (mean (SD) SPI24=102 (43), 95% CI 95 to 109) compared with placebo patients (n=184; SPI24=117 (45), 95% CI 111 to 123, p=0.002). SPI48 was 190 (88, 95% CI 177 to 204) for INL-001 and 206 (96, 95% CI 192 to 219) for placebo, and not significantly different between groups. The subsequent secondary variables were therefore declared not statistically significant. SPI72 was 265 (131, 95% CI 244 to 285) for INL-001 and 281 (146, 95% CI 261 to 301) for placebo. The opioid-free percentage of patients at 24, 48, and 72 hours was 19%, 17%, and 17% for INL-001 and 6.5% for placebo patients (at all timepoints). The only adverse event occurring in ≥5% of patients and for which proportion INL-001 >placebo was back pain (7.7% vs 7.6%).

CONCLUSION: The study design was limited by not containing an active comparator. Compared with placebo, INL-001 provides postoperative analgesia that is temporally aligned with the period of maximal postsurgical pain in abdominoplasty and offers a favorable safety profile.

TRIAL REGISTRATION NUMBER: NCT04785625.

PMID:37076252 | DOI:10.1136/rapm-2022-104110

BMJ Open. 2023 Apr 19;13(4):e066630. doi: 10.1136/bmjopen-2022-066630.

ABSTRACT

OBJECTIVE: This study aimed to investigate the prevalence of cognitive frailty among older adults in China.

DESIGN: Systematic review and meta-analysis.

METHODS: We searched the Cochrane Library, PubMed, Web of Science, Embase, China National Knowledge Infrastructure(CNKI), Wanfang, Chinese Biomedical Literature and Weipu (VIP) databases to collect information on the epidemiology of cognitive frailty among older adults in China. The study period was from the establishment of the database to March 2022. Two researchers independently screened the literature, extracted the data and assessed the risk of bias in the included studies. All statistical analyses were performed using Stata V.15.0.

RESULTS: We screened 522 records, of which 28 met the inclusion criteria. The results of the meta-analysis showed that the prevalence of cognitive frailty among older adults in China was 15%(95%CI (0.13%,0.17%)). The prevalence of cognitive frailty was higher in hospitals and nursing homes than in communities. Moreover, the prevalence of cognitive frailty was higher in women than in men. Furthermore, the prevalence rates of cognitive frailty in North China Hospital, older adults aged≥80 years, and illiterate individuals were 25%, 29%, and 55%, respectively.

CONCLUSIONS: In conclusion, in China, the prevalence of cognitive frailty is higher among older adults, is higher in women than in men, is higher in hospitals and nursing homes than in communities, and is higher in North China than other regions. Moreover, the higher the educational level, the lower the prevalence of cognitive frailty. Multimodal interventions for cognitive frailty, including increased exercise, nutritional support, increased socialisation opportunities and multifactorial strategies, may be effective in preventing cognitive frailty. These findings have important implications for adjusting healthcare and social care systems.

PROSPERO REGISTRATION NUMBER: CRD42023390486.

PMID:37076151 | DOI:10.1136/bmjopen-2022-066630

Nephrology (Carlton). 2023 Apr 19. doi: 10.1111/nep.14160. Online ahead of print.

ABSTRACT

AIMS: Predicting progression to kidney failure for patients with chronic kidney disease is essential for patient and clinicians’ management decisions, patient prognosis, and service planning. The Tangri et al Kidney Failure Risk Equation (KFRE) was developed to predict the outcome of kidney failure. The KFRE has not been independently validated in an Australian Cohort.

METHODS: Using data linkage of the Tasmanian Chronic Kidney Disease study (CKD.TASlink) and the Australia and New Zealand Dialysis and Transplant Registry (ANZDATA), we externally validated the KFRE. We validated the 4, 6, and 8-variable KFRE at both 2 and 5 years. We assessed model fit (goodness of fit), discrimination (Harell’s C statistic), and calibration (observed vs predicted survival).

RESULTS: There were 18 170 in the cohort with 12 861 participants with 2 years and 8182 with 5 years outcomes. Of these 2607 people died and 285 progressed to kidney replacement therapy. The KFRE has excellent discrimination with C statistics of 0.96-0.98 at 2 years and 0.95-0.96 at 5 years. The calibration was adequate with well-performing Brier scores (0.004-0.01 at 2 years, 0.01-0.03 at 5 years) however the calibration curves, whilst adequate, indicate that predicted outcomes are systematically worse than observed.

CONCLUSION: This external validation study demonstrates the KFRE performs well in an Australian population and can be used by clinicians and service planners for individualised risk prediction.

PMID:37076122 | DOI:10.1111/nep.14160