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PMC11278385_p40
PMC11278385
sec[3]/p[12]
4. Discussion
4.175781
biomedical
Study
[ 0.99853515625, 0.0014209747314453125, 0.00014865398406982422 ]
[ 0.9970703125, 0.0009851455688476562, 0.0014677047729492188, 0.0002574920654296875 ]
Within our cohort, one patient exposed to ixekizumab developed microscopic colitis. Cases of microscopic colitis occurring during IL-17i therapy have already been documented in the worldwide pharmacovigilance database , and IL-17i were previously associated with increased rates of AEs and the exacerbation of symptoms related to Crohn’s disease . A rate of new cases of Crohn’s disease and ulcerative colitis of less than 1% were documented in PsO patients . As seen from a pooled analysis of the open-label period of SPIRIT-P1, SPIRIT-P2, and SPIRIT-P3, the rate of chronic inflammatory bowel diseases among PsA patients treated with ixekizumab was 0.2% . Hence, although the evidence suggests a low rate of new onset of inflammatory bowel disease among patients exposed to ixekizumab, careful screening seems relevant especially in presence of symptoms suspicious for IBD. Considering real-life data, comparable findings were presented by Braña et al., where the predominant AEs were cutaneous and gastrointestinal, including a new diagnosis of Crohn’s disease .
[ "Elisa Bellis", "Piero Ruscitti", "Denise Donzella", "Gloria Crepaldi", "Valeria Data", "Marinella Gammino", "Mariele Gatto", "Valeria Guardo", "Claudia Lomater", "Elena Marucco", "Marta Saracco", "Annamaria Iagnocco" ]
https://doi.org/10.3390/jpm14070716
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278385_p41
PMC11278385
sec[3]/p[13]
4. Discussion
1.928711
biomedical
Clinical case
[ 0.5087890625, 0.484375, 0.006969451904296875 ]
[ 0.02813720703125, 0.1610107421875, 0.0029430389404296875, 0.80810546875 ]
Lastly, a patient received a diagnosis of lung cancer shortly after beginning therapy, despite screening performed prior to prescription with a chest X-ray. However, the diagnosis occurred soon after the induction period, so a direct link to ixekizumab administration seems unlikely.
[ "Elisa Bellis", "Piero Ruscitti", "Denise Donzella", "Gloria Crepaldi", "Valeria Data", "Marinella Gammino", "Mariele Gatto", "Valeria Guardo", "Claudia Lomater", "Elena Marucco", "Marta Saracco", "Annamaria Iagnocco" ]
https://doi.org/10.3390/jpm14070716
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278385_p42
PMC11278385
sec[3]/p[14]
4. Discussion
2.550781
biomedical
Study
[ 0.99609375, 0.0027980804443359375, 0.0010290145874023438 ]
[ 0.9931640625, 0.0056915283203125, 0.0007319450378417969, 0.0005168914794921875 ]
Our study has certain limitations, primarily due to its retrospective monocentric design, which led to a lack of data concerning minor AEs, especially those that did not result in treatment discontinuation, as well as in the assessment of disease activity.
[ "Elisa Bellis", "Piero Ruscitti", "Denise Donzella", "Gloria Crepaldi", "Valeria Data", "Marinella Gammino", "Mariele Gatto", "Valeria Guardo", "Claudia Lomater", "Elena Marucco", "Marta Saracco", "Annamaria Iagnocco" ]
https://doi.org/10.3390/jpm14070716
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278385_p43
PMC11278385
sec[3]/p[15]
4. Discussion
3.9375
biomedical
Study
[ 0.99853515625, 0.0011072158813476562, 0.0002503395080566406 ]
[ 0.9970703125, 0.0023326873779296875, 0.0005168914794921875, 0.00015676021575927734 ]
On the other hand, based on the current literature in the field, our cohort is among the largest and most well-characterized monocentric real-world cohorts of patients on ixekizumab so far, thereby offering valuable real-life insights on ixekizumab use in PsA patients and providing important data about DRR and safety, particularly among patients with multiple comorbidities.
[ "Elisa Bellis", "Piero Ruscitti", "Denise Donzella", "Gloria Crepaldi", "Valeria Data", "Marinella Gammino", "Mariele Gatto", "Valeria Guardo", "Claudia Lomater", "Elena Marucco", "Marta Saracco", "Annamaria Iagnocco" ]
https://doi.org/10.3390/jpm14070716
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278385_p44
PMC11278385
sec[3]/p[16]
4. Discussion
4.128906
biomedical
Study
[ 0.99755859375, 0.0022754669189453125, 0.00021266937255859375 ]
[ 0.998046875, 0.0011568069458007812, 0.00067901611328125, 0.00024437904357910156 ]
In conclusion, in our study, ixekizumab revealed a good DRR and safety profile, even among patients with multiple treatment failures, comorbidities, and obesity, which are common in PsA patients. The prior use of methotrexate did not affect DRR in our study, in contrast to previous findings . Additionally, we observed comparable efficacy in both peripheral and axial phenotypes, despite a negative trend in the latter. Moreover, our data suggest that initiating ixekizumab earlier may provide additional benefits. However, addressing these points will require larger sample sizes and further studies.
[ "Elisa Bellis", "Piero Ruscitti", "Denise Donzella", "Gloria Crepaldi", "Valeria Data", "Marinella Gammino", "Mariele Gatto", "Valeria Guardo", "Claudia Lomater", "Elena Marucco", "Marta Saracco", "Annamaria Iagnocco" ]
https://doi.org/10.3390/jpm14070716
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p0
PMC11278397
sec[0]/p[0]
1. Introduction
3.957031
biomedical
Review
[ 0.99755859375, 0.0011339187622070312, 0.0013551712036132812 ]
[ 0.043853759765625, 0.00579833984375, 0.94970703125, 0.0004458427429199219 ]
Anxiety disorders are an emerging pathology characterized by excessive fear and anxiety along with related behavioral problems that are severe enough to cause significant distress or impairment in personal, family, and social , functioning of those who suffer from them. Recently, anxiety has begun to be recognized as a comorbidity that affects the evolutionary course of other diseases, such as chronic obstructive pulmonary disease (COPD), in which it can significantly alter the clinical expression of the disease. The overlap between high levels of comorbidity and COPD is associated with a poor clinical and prognostic outcome .
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278397_p1
PMC11278397
sec[0]/p[1]
1. Introduction
3.691406
biomedical
Study
[ 0.99853515625, 0.0002579689025878906, 0.0011072158813476562 ]
[ 0.53759765625, 0.0164642333984375, 0.445556640625, 0.0004038810729980469 ]
The prevalence of anxiety in the adult population ranges from 6.7% to 13% , and is 9.2% in women . The anxiety prevalence in patients with COPD is highly variable, ranging from 6% to 70%, depending on the type of population , the severity of the disease , and the instruments used for diagnosis, but it is higher in COPD patients than in the healthy population; various authors have also reported an anxiety prevalence in COPD patients of around 44% .
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278397_p2
PMC11278397
sec[0]/p[2]
1. Introduction
3.947266
biomedical
Review
[ 0.994140625, 0.0030364990234375, 0.0030059814453125 ]
[ 0.00983428955078125, 0.0013170242309570312, 0.98876953125, 0.0003139972686767578 ]
A patient with COPD has a 2.5 times higher risk of experiencing anxiety than the general population . In a systematic review of 152 articles published in the Revue des Maladies Respiratoires, Underner et al. found an anxiety prevalence ranging from 6.7% to 58% in COPD patients and observed positive associations between anxiety prevalence and the risk of respiratory exacerbations. Another systematic review by Pooler and Beech , observed an increased risk of exacerbations, longer hospital stays, and a higher risk of mortality.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p3
PMC11278397
sec[0]/p[3]
1. Introduction
2.533203
biomedical
Other
[ 0.98876953125, 0.003482818603515625, 0.0077362060546875 ]
[ 0.02276611328125, 0.7666015625, 0.2081298828125, 0.002536773681640625 ]
Perpiña-Galvan , points out that “many researchers believe that a systematic assessment of possible psychological disorders such as anxiety and depression should be part of the management of respiratory disease. Despite the evident relationship between anxiety and respiratory disease, anxiety disorders remain underdiagnosed and undertreated in respiratory patients”.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p4
PMC11278397
sec[0]/p[4]
1. Introduction
3.984375
biomedical
Study
[ 0.9970703125, 0.002471923828125, 0.0003581047058105469 ]
[ 0.9990234375, 0.0005822181701660156, 0.0003910064697265625, 0.0001894235610961914 ]
Despite the evidence showing a high prevalence and an exceedingly negative impact of depression and anxiety in patients with COPD, depression and anxiety are rarely screened in clinical practice. Possible explanations for these findings are that depression and anxiety are not routinely screened in medicine clinics, or that the patients may not report their depression and anxiety symptoms to their doctors . Given these facts, the aim of this study was to evaluate the suspected diagnosis of anxiety in patients with COPD referred from primary care centers to pulmonology services, using a simple test such as the HADS test, prior to their possible referral to specialized mental health services.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278397_p5
PMC11278397
sec[0]/p[5]
1. Introduction
3.107422
biomedical
Study
[ 0.99609375, 0.0030422210693359375, 0.0010271072387695312 ]
[ 0.99072265625, 0.008697509765625, 0.0004639625549316406, 0.0003368854522705078 ]
The secondary objective was to assess the existence of predictive factors that could alert the doctors responsible for the diagnosis and monitoring of COPD to the presence of a mental disorder such as anxiety, which can influence the disease’s course.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p6
PMC11278397
sec[1]/p[0]
2. Materials and Methods
1.754883
biomedical
Study
[ 0.98974609375, 0.0027751922607421875, 0.00733184814453125 ]
[ 0.95947265625, 0.035888671875, 0.0035495758056640625, 0.0012359619140625 ]
The study protocol has been previously published in another study on depression and COPD .
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278397_p7
PMC11278397
sec[1]/sec[0]/p[0]
2.1. Ethical Aspects
1.526367
biomedical
Other
[ 0.93798828125, 0.03607177734375, 0.0257415771484375 ]
[ 0.1669921875, 0.8271484375, 0.0011529922485351562, 0.004558563232421875 ]
This study has been approved by the Clinical Research Ethics Committee (CEIC) of the Health Area of Salamanca . All participants signed an informed consent form prior to the study in accordance with the Declaration of Helsinki and World Health Organization standards for observational studies . During the development of this study, no alteration was required in the medical procedures for which the patients attended medical consultations. Patient data were treated confidentially in accordance with the provisions of current legislation on personal data protection and the conditions outlined by Act 14/2007 on biomedical research . The patients were informed of the proposed objectives and benefits of the project, and they were free to withdraw from the study at any time.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p8
PMC11278397
sec[1]/sec[1]/p[0]
2.2. Patients and Study Design
2.113281
biomedical
Study
[ 0.986328125, 0.0114898681640625, 0.0022869110107421875 ]
[ 0.85205078125, 0.1407470703125, 0.002979278564453125, 0.004039764404296875 ]
The patients recruited for the study were referred from two primary care centers to their reference pulmonology services, which are departments that share care for COPD patients. For the diagnosis and classification of COPD, the recommendations of the GesEPOC , and GOLD , guidelines that took effect in 2022 were followed.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p9
PMC11278397
sec[1]/sec[1]/p[1]
2.2. Patients and Study Design
3.144531
biomedical
Study
[ 0.99462890625, 0.004665374755859375, 0.00066375732421875 ]
[ 0.9970703125, 0.002048492431640625, 0.0002636909484863281, 0.0005240440368652344 ]
This was an observational, multicentric, prospective, transversal study with a non-probabilistic sample. All patients were observed during a consecutive period of six months, regardless of age, sex, stage of their COPD, or treatment.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p10
PMC11278397
sec[1]/sec[1]/p[2]
2.2. Patients and Study Design
3.925781
biomedical
Study
[ 0.99755859375, 0.002269744873046875, 0.0002410411834716797 ]
[ 0.99755859375, 0.0016584396362304688, 0.00033020973205566406, 0.0002111196517944336 ]
Patients who agreed to participate underwent a complete respiratory history, an updated smoking history, and spirometry with a bronchodilator test to verify that they met the diagnostic criteria for COPD. The diagnosis of anxiety was made using the corresponding scale of the HADS test based on the Spanish validation , and previous studies carried out with said scale . The cutoff point for establishing a suspicion of anxiety was set at a value greater than 7.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278397_p11
PMC11278397
sec[1]/sec[2]/p[0]
2.3. Statistical Analysis
3.464844
biomedical
Study
[ 0.9990234375, 0.0003616809844970703, 0.00038361549377441406 ]
[ 0.9970703125, 0.00264739990234375, 0.00041866302490234375, 0.00010770559310913086 ]
For the descriptive analysis, absolute and relative frequencies of all qualitative variables and the mean and standard deviation for quantitative variables were determined. A comparison of scores was performed using the student’s t -test for independent samples.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p12
PMC11278397
sec[1]/sec[2]/p[1]
2.3. Statistical Analysis
3.998047
biomedical
Study
[ 0.99951171875, 0.0003204345703125, 0.00029587745666503906 ]
[ 0.99951171875, 0.00023543834686279297, 0.00033593177795410156, 0.00005453824996948242 ]
An analysis of factors influencing the psychiatric diagnosis was conducted using binary logistic regression. In each situation, to estimate the risk in a univariate manner, the odds ratio (OR), with its corresponding 95% confidence intervals, was used. Finally, for the evaluation of predictors of anxiety, a multivariate analysis was conducted using logistic regression, including the significant variables from the binary analysis and another multivariate analysis of all the variables included in the study.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999999
PMC11278397_p13
PMC11278397
sec[1]/sec[2]/p[2]
2.3. Statistical Analysis
1.4375
biomedical
Other
[ 0.95166015625, 0.0012998580932617188, 0.04705810546875 ]
[ 0.317138671875, 0.68017578125, 0.0014171600341796875, 0.0011301040649414062 ]
The criterion for significance was set at p < 0.05. All statistical analyses were performed using IBM SPSS Statistics software version 20 (International Business Machines, Armonk, NY, USA) under the supervision of the company Cenit Support Systems S.L.U. on the business campus of the University of Salamanca.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p14
PMC11278397
sec[2]/p[0]
3. Results
3.425781
biomedical
Study
[ 0.9970703125, 0.002605438232421875, 0.00048279762268066406 ]
[ 0.99853515625, 0.0009617805480957031, 0.00015246868133544922, 0.0002321004867553711 ]
The study included 229 men and 64 women with a mean age of 68.2 ± 10.3 years (range 40 to 91 years). The mean height was 165.8 ± 8.6 cm (range 140 to 191 cm), the mean weight was 74.4 ± 15.4 kg (range 38 to 165 kg), and the mean body mass index was 27 (range 18 to 45). A total of 127 patients live in rural areas and 166 in urban areas; 47 patients (19.5%) live alone.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999999
PMC11278397_p15
PMC11278397
sec[2]/p[1]
3. Results
3.753906
biomedical
Study
[ 0.998046875, 0.0017070770263671875, 0.0003867149353027344 ]
[ 0.9990234375, 0.0006971359252929688, 0.00018870830535888672, 0.00013911724090576172 ]
At the time of inclusion in the study, 93 patients (31.7%) still smoked and 200 (68.3%) did not, although all had been smokers with an average consumption of 25.5 ± 13.6 cigarettes/day, an average smoking history of 39.7 ± 11.5 years, which corresponds to a pack-year index (PYI) of 50.7 ± 29.9. For the ex-smokers, the mean number of years since they quit smoking was 11.7 ± 0.7.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278397_p16
PMC11278397
sec[2]/p[2]
3. Results
4.078125
biomedical
Study
[ 0.99365234375, 0.005939483642578125, 0.00022470951080322266 ]
[ 0.99755859375, 0.00112152099609375, 0.0006165504455566406, 0.0005908012390136719 ]
The mean time from COPD diagnosis to inclusion in the study was 6.6 ± 6.4 years. The predominant symptom was exertional dyspnea grades II and III according to the mMRC (modified Medical Research Council) scale (29.7% and 18.9%, respectively); the mean BODEx index value was 2.93 ± 1.99. In the past year, 52.6% of the patients had experienced an exacerbation (mean of 2 ± 1.4).
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278397_p17
PMC11278397
sec[2]/p[3]
3. Results
3.730469
biomedical
Study
[ 0.9873046875, 0.01247406005859375, 0.00036716461181640625 ]
[ 0.99267578125, 0.00579833984375, 0.0006232261657714844, 0.0008740425109863281 ]
Regarding the severity of airway obstruction, according with GOLD Guidelines, 127 patients (43.4%) had moderate obstruction, and 98 patients (33.45%) had severe obstruction. Another 42 patients (14.33%) had mild obstruction, and 26 (8.87%) had very severe obstruction.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278397_p18
PMC11278397
sec[2]/p[4]
3. Results
3.742188
biomedical
Study
[ 0.99755859375, 0.0021152496337890625, 0.00021529197692871094 ]
[ 0.99169921875, 0.006168365478515625, 0.0018033981323242188, 0.00039124488830566406 ]
According to the criteria of the Spanish COPD Guidelines (GesEPOC) , 64.5% of the patients were classified as high risk and 35.5% as low risk; the most frequent phenotype was the exacerbator with emphysema (109 patients; 37.2%) and the least frequent was the mixed phenotype (20 patients; 6.8%).
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278397_p19
PMC11278397
sec[2]/p[5]
3. Results
3.066406
biomedical
Study
[ 0.9970703125, 0.0021266937255859375, 0.000736236572265625 ]
[ 0.99462890625, 0.004520416259765625, 0.0004277229309082031, 0.0002321004867553711 ]
Based on the classification of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), which is valid until 2022 , a distribution of patients across different groups was observed. The most frequent groups (B and D) consisted of 169 patients (57.7%), and these groups included patients with more symptoms. The less frequent groups (A and C) consisted of 124 patients (42.3%), and these groups included patients with fewer symptoms.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278397_p20
PMC11278397
sec[2]/p[6]
3. Results
4.03125
biomedical
Study
[ 0.9921875, 0.007259368896484375, 0.00035858154296875 ]
[ 0.9970703125, 0.0014410018920898438, 0.0008816719055175781, 0.0003790855407714844 ]
The average score on the COPD Assessment Test (CAT) was 14.6 ± 6.9 points. The clinical impact was analyzed according to the same scale used by Jiménez et al. . Thus, 83 patients (28.3%) reported no impact on their quality of life or a very low impact (CAT: ≤10), and 210 patients (71.7%) reported some impact. Of these, 162 (55.3%) reported a moderate impact (CAT: 11–20), 40 (13.6%) reported a high impact (CAT: 21–30), and 8 (2.73%) reported a very high impact (CAT: 31–40).
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278397_p21
PMC11278397
sec[2]/p[7]
3. Results
2.900391
biomedical
Study
[ 0.99755859375, 0.0006866455078125, 0.0018301010131835938 ]
[ 0.998046875, 0.0013952255249023438, 0.00024259090423583984, 0.00008857250213623047 ]
An assessment of anxiety was conducted using the HADS test. Table 1 summarizes the results of the Hospital Anxiety and Depression Scale (HADS) for anxiety. The participants were divided into three groups based on their scores: 7 or less, between 8 and 10, and 11 or more. The table shows the frequency and percentage of participants in each group, along with the mean score and the p -value for each group. The p -value indicates statistical significance, with all values being <0.001.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p22
PMC11278397
sec[2]/p[8]
3. Results
2.556641
biomedical
Study
[ 0.994140625, 0.003772735595703125, 0.0020160675048828125 ]
[ 0.99462890625, 0.004550933837890625, 0.0003285408020019531, 0.000423431396484375 ]
Table 1 presents the observed results on the anxiety scale of the HADS test. The cutoff point for establishing the suspicion of anxiety was set at a value > 7. Frequency analysis showed 208 patients without anxiety. A diagnosis of suspected anxiety was established in 85 patients (29.0%): 17 possible and 68 with a strong suspicion.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278397_p23
PMC11278397
sec[2]/p[9]
3. Results
3.576172
biomedical
Study
[ 0.99560546875, 0.003078460693359375, 0.0011892318725585938 ]
[ 0.9990234375, 0.00037980079650878906, 0.00027251243591308594, 0.00013077259063720703 ]
Out of the 293 patients, 27 (9.2%) had a prior clinical diagnosis of anxiety established by a mental health unit, while 266 did not. Table 2 shows the average scores in each of the three groups studied. Despite the large difference in the number of patients with a prior diagnosis compared to the other two groups, the observed differences were significant. The average score was 4.9 points higher for patients with a prior diagnosis of anxiety compared to the undiagnosed group, confirming the usefulness of the test used.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p24
PMC11278397
sec[2]/p[10]
3. Results
3.916016
biomedical
Study
[ 0.9990234375, 0.0004706382751464844, 0.0007476806640625 ]
[ 0.99951171875, 0.00022113323211669922, 0.00020575523376464844, 0.00004762411117553711 ]
Bivariate and multivariate analyses were conducted to determine the influence of the variables included in the study on the likelihood of patients suffering anxiety. Table 3 summarizes the results of the logistic regression analysis for predictors of anxiety. It includes the Wald statistic, p -value, odds ratio (OR), and the 95% confidence interval (CI) for each variable.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278397_p25
PMC11278397
sec[2]/p[11]
3. Results
4.019531
biomedical
Study
[ 0.99755859375, 0.0003597736358642578, 0.00225830078125 ]
[ 0.99951171875, 0.00017189979553222656, 0.00020778179168701172, 0.00003141164779663086 ]
Only personal factors such as being female, weight, and BMI showed significant influence. The Wald test indicates that being female had a positive influence (higher probability), while weight and BMI had an inverse influence, meaning that lower weight was associated with a higher probability of experiencing anxiety. The risk analysis showed that women were 3.5 times more likely to experience anxiety than men. Regarding weight, the value was less than 1, indicating that for each kilogram reduction in weight, the risk of experiencing anxiety increased by one point (1/0.955 = 1.047), and the same applied to BMI (1/0.907 = 1.102). The influence of these last two variables disappeared in the multivariate analysis, with only being female remaining as a predictive factor.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278397_p26
PMC11278397
sec[2]/p[12]
3. Results
3.082031
biomedical
Study
[ 0.998046875, 0.00084686279296875, 0.0008754730224609375 ]
[ 0.99853515625, 0.0007143020629882812, 0.0004761219024658203, 0.00010216236114501953 ]
An analysis of the results showed that personal variables such as age and form of residence (urban or rural) did not have a significant impact. Similarly, variables related to tobacco consumption, clinical manifestations, lung function, and disease classification according to GesEPOC (both phenotype and risk) or GOLD did not show a significant influence. Although a trend was observed in some cases, it was not strong enough to be considered influential.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278397_p27
PMC11278397
sec[3]/p[0]
4. Discussion
4.042969
biomedical
Study
[ 0.99951171875, 0.0004222393035888672, 0.00014448165893554688 ]
[ 0.99755859375, 0.0005135536193847656, 0.0015964508056640625, 0.0001195669174194336 ]
A definitive diagnosis of a mental disorder is clinical and performed by psychiatrists in mental health units through a structured psychiatric interview. However, there are a wide range of tests available, including the HADS, which facilitates the establishment of a presumptive diagnosis and allows for the referral of the patient to a psychiatrist for a definitive diagnosis and subsequent joint follow-up. In a previous study by González et al. , a high concordance was found between a positive HADS (using the same cutoff points as in our study) and a confirmatory psychiatric diagnosis of anxiety (Cohen’s Kappa index of 0.885, p < 0.001). Therefore, due to its simplicity, the HADS test may be useful for clinicians who are not experts in diagnosing psychosocial disorders.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p28
PMC11278397
sec[3]/p[1]
4. Discussion
2.064453
biomedical
Other
[ 0.99267578125, 0.003818511962890625, 0.0034236907958984375 ]
[ 0.0175933837890625, 0.94580078125, 0.034393310546875, 0.0021686553955078125 ]
Mental disorders are more prevalent in patients with COPD than in the general population and are more prevalent in women than in men . Anxiety and depression are underdiagnosed in this group of patients, and anxiety is possibly even more underdiagnosed than depression.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999999
PMC11278397_p29
PMC11278397
sec[3]/p[2]
4. Discussion
4.050781
biomedical
Study
[ 0.99951171875, 0.0002224445343017578, 0.00020301342010498047 ]
[ 0.998046875, 0.0002332925796508789, 0.0014543533325195312, 0.00007075071334838867 ]
Brenes indicated in Psychosom. Med. in 2003 that anxiety was three times more common in patients with COPD than in the general population. However, as we have already noted, the reported prevalence is highly variable: 5.6% in the study by Kull et al. , 26.5% in the study by González-Gutiérrez et al. , and 8.1% in the most recent study by Xiao et al. . The prevalence observed in our study, using the HADS test and setting the scale cutoff point at ≥ 8, was 28.9%, with a total of 85 patients scoring eight points or higher. This is close to the prevalence found by González-Gutiérrez et al. , which had a population group similar to ours . It is noteworthy that in our study, only 27 patients (9.2%) had an established anxiety diagnosis, leading to the conclusion that there was significant underdiagnosis in the studied population. The EPISCAN II study , a population-based study that also used the HADS test, showed an anxiety prevalence of 27.4% in the COPD group.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278397_p30
PMC11278397
sec[3]/p[3]
4. Discussion
3.896484
biomedical
Review
[ 0.99853515625, 0.0006008148193359375, 0.0006384849548339844 ]
[ 0.1304931640625, 0.0085906982421875, 0.8603515625, 0.0005316734313964844 ]
When studying the psychiatric comorbidities that influence COPD, depression is more commonly considered than anxiety. The opposite is true for asthma, possibly due to a gender bias resulting from a higher prevalence of asthma in women and a higher prevalence of COPD in men. However, anxiety is a common comorbidity in COPD and has a significant impact on the quality of life and survival of these patients. In fact, the COTE index (COPD Specific Comorbidity Test) includes anxiety among the specific comorbidities associated with COPD that determine increases in mortality .
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278397_p31
PMC11278397
sec[3]/p[4]
4. Discussion
3.318359
biomedical
Study
[ 0.998046875, 0.0008869171142578125, 0.001216888427734375 ]
[ 0.998046875, 0.0013647079467773438, 0.0005650520324707031, 0.00010955333709716797 ]
An important aspect is to analyze the existence of possible predictive factors that could serve as warning signs for clinicians who suspect the possibility of anxiety. In this regard, only a few personal factors such as being female, weight, and BMI showed significance, while other personal factors such as age, which had shown significance in the study by González et al. , did not show a relationship in our study. Regarding disease-related factors, they did not show a significant influence, although there was a trend related to a greater severity of the disease, which makes early identification of anxiety in these patients more challenging.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p32
PMC11278397
sec[3]/p[5]
4. Discussion
3.457031
biomedical
Study
[ 0.9990234375, 0.00029349327087402344, 0.0005431175231933594 ]
[ 0.99853515625, 0.0006051063537597656, 0.0005664825439453125, 0.00006598234176635742 ]
These results contrast with those observed by our research group in relation to depression , in which the personal factors that showed influence included age and living alone. Additionally, other aspects related to the disease itself, such as the CAT score, BODEx index, degree of bronchial obstruction, phenotype, and risk factors (GesEPOC), as well as GOLD classification grades C and D, also showed significance.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278397_p33
PMC11278397
sec[3]/p[6]
4. Discussion
3.134766
biomedical
Study
[ 0.9990234375, 0.0003209114074707031, 0.0007581710815429688 ]
[ 0.99853515625, 0.0009026527404785156, 0.00044989585876464844, 0.00007742643356323242 ]
Anxiety is more prevalent in women, while COPD is more prevalent in men, leading to few women being included in studies on patients diagnosed with COPD. Mayoral et al. observed that among women diagnosed with COPD, 43.1% had a history of anxiety. In our study, only 21.8% of the participants were women; however, this is a higher percentage than that of other studies. The fact that being female is consistently reaffirmed as a predictive factor in all analyses conducted gives greater significance to this finding.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p34
PMC11278397
sec[3]/p[7]
4. Discussion
3.771484
biomedical
Study
[ 0.9990234375, 0.0008134841918945312, 0.000347137451171875 ]
[ 0.94873046875, 0.007747650146484375, 0.043182373046875, 0.00041985511779785156 ]
Smoking cessation and pulmonary rehabilitation have been shown to be the only factors capable of modifying the evolutionary course of COPD. Bronchodilator treatment improves the quality of life for these patients and reduces their perception of dyspnea. However, in the case of patients with comorbid anxiety, treating the anxiety could improve their perception of dyspnea in particular and contribute to an overall improvement in quality of life. Despite this, less than one-third of patients with COPD receive adequate treatment for anxiety. This aspect was not addressed in our study, but it is one of the factors to be considered in future research.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278397_p35
PMC11278397
sec[3]/p[8]
4. Discussion
2.056641
biomedical
Study
[ 0.98828125, 0.00067901611328125, 0.01111602783203125 ]
[ 0.9833984375, 0.01497650146484375, 0.0014276504516601562, 0.00024890899658203125 ]
This study has limitations derived from the specific Spanish population that was included and the correlational nature of the study. These limitations could affect the generalizability of the study’s findings, especially regarding the predictive factors.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p36
PMC11278397
sec[3]/p[9]
4. Discussion
3.335938
biomedical
Other
[ 0.978515625, 0.01800537109375, 0.003536224365234375 ]
[ 0.007076263427734375, 0.93310546875, 0.05804443359375, 0.0016889572143554688 ]
The most updated versions of COPD management guidelines, such as GesEPOC and GOLD , recommend a specific assessment of the psychosocial status of these patients. However, these recommendations are far from routine clinical practice, likely due to multifactorial causes, including diagnostic difficulty. Therefore, it is of interest to have simple tests such as the HADS test that can guide the presumptive diagnosis of anxiety and allow for the referral of patients to mental health units.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278397_p37
PMC11278397
sec[4]/p[0]
5. Conclusions
2.919922
biomedical
Other
[ 0.966796875, 0.027435302734375, 0.00568389892578125 ]
[ 0.001377105712890625, 0.99267578125, 0.004669189453125, 0.0014448165893554688 ]
Anxiety is a prevalent mental illness in patients with COPD, but it is underdiagnosed. The use of simple tools like the HADS test in primary care and pulmonology services could facilitate a diagnosis and the referral of patients to mental health units. A multidisciplinary approach involving family medicine, pulmonology, and psychiatry would be a strategic alliance that could help improve the health status of COPD patients and the overall course of the disease.
[ "Enrique Barrueco", "Miguel A. Hernández-Mezquita", "Vanesa Hidalgo-Sierra", "Rosa Cordovilla", "Javier Olivera-Pueyo", "Javier Galán" ]
https://doi.org/10.3390/jpm14070713
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278409_p0
PMC11278409
sec[0]/p[0]
1. Introduction
4.398438
biomedical
Review
[ 0.998046875, 0.00115966796875, 0.0006842613220214844 ]
[ 0.163330078125, 0.0036468505859375, 0.83203125, 0.0011959075927734375 ]
Lamellar macular hole (LMH) is morphologically characterized by the presence of a partial defect in the inner foveal layers, not extending to the entire retina, with irregular foveal contour . With the advent of optical coherence tomography (OCT), different classifications and subtypes of LMH have been proposed . More recently, an OCT-based consensus renamed two clinical subtypes: “epiretinal membrane-foveoschisis” (ERM-FS), characterized by the presence of a contractile ERM and foveoschisis at the level of Henle fiber layer (HFL) and a (degenerative) LMH, characterized by a foveal cavity with undermined edges and signs evoking loss of foveal tissue . The pathophysiology of LMH is still largely unknown ; however, two main mechanisms have been described: (i) a contractile membrane causing traction in ERM-FS and (ii) loss of retinal tissue in D-LMH . Both mechanisms produce asymmetric three-dimensional (3D) changes on the macula.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278409_p1
PMC11278409
sec[0]/p[1]
1. Introduction
3.970703
biomedical
Study
[ 0.99951171875, 0.00025916099548339844, 0.00017631053924560547 ]
[ 0.95263671875, 0.0011043548583984375, 0.04620361328125, 0.00028586387634277344 ]
LMH is a slowly progressive condition that can impair visual acuity (VA) in a subset of patients . Although pars plana vitrectomy (PPV) and internal limiting membrane (ILM) peeling is the established surgical approach for LMH, there is no general consensus regarding quantitative parameters that can help decide on the timing of surgery or predict the visual outcome . It has been highlighted that LMH is an asymmetric, 3D disease of the macula, better defined by volumetric analysis rather than linear measurements . Most previous studies on LMH, were limited by the analysis of measurements from linear OCT macular scans, which do not provide adequate information on retinal tissue remodeling .
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278409_p2
PMC11278409
sec[0]/p[2]
1. Introduction
4.101563
biomedical
Study
[ 0.998046875, 0.0018396377563476562, 0.0002300739288330078 ]
[ 0.99853515625, 0.0007395744323730469, 0.0003330707550048828, 0.00021970272064208984 ]
The aim of our study was to investigate novel OCT parameters, based on the volumetric analysis of ERM foveoschisis (ERM-FS) and degenerative LMH (D-LMH), as prognostic indicators for post-operative best-corrected visual acuity (BCVA) logMAR after surgery. Additionally, due to the functional importance of 0.30 logMAR BCVA, such as for driving, we investigate the effect of pre-operative BCVA on achieving this threshold postoperatively.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278409_p3
PMC11278409
sec[1]/p[0]
2. Materials and Methods
4.152344
biomedical
Study
[ 0.97509765625, 0.0242919921875, 0.0004112720489501953 ]
[ 0.99072265625, 0.005336761474609375, 0.0015010833740234375, 0.00257110595703125 ]
This is a retrospective interventional, single-center case series that adhered to the guidelines of the Declaration of Helsinki. Under UK guidance, retrospective data collection is regarded as an audit for the purpose of service evaluation, and as such ethical approval was not required. Diagnosis and treatment were conducted according to local guidelines with no new or experimental protocols. Clinical records were extracted from an electronic surgical database of consecutive eyes that underwent PPV for LMH repair at Manchester Royal Eye Hospital, UK, from January 2020 to January 2023. Eyes with LMH which had pre-operative macular OCT using the “dense macular volume” scan with Heidelberg Spectralis (Engineering GmbH, Heidelberg, Germany), were included. Exclusion criteria were (1) high myopia (more than 6 diopters); (2) advanced glaucoma; (3) any concomitant retinal disease involving the macula, such as diabetic maculopathy, retinal vein occlusion, age-related macular degeneration; (4) any comorbidity potentially impacting on final functional outcomes, such as uveitis or amblyopia; (5) history of trauma; (6) previous intraocular surgery other than cataract surgery performed more than 6 months before vitrectomy; (7) OCT with poor image quality; and (8) post-operative follow-up (FU) less than 4 weeks.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278409_p4
PMC11278409
sec[1]/p[1]
2. Materials and Methods
3.861328
biomedical
Study
[ 0.99951171875, 0.0005054473876953125, 0.00017154216766357422 ]
[ 0.9970703125, 0.00234222412109375, 0.0004105567932128906, 0.00016748905181884766 ]
We subsequently divided the included eyes in two subtypes, degenerative LMH (D-LMH) and ERM foveoschisis (ERM-FS), based on the OCT-based consensus definition for LMH , as defined and shown in Figure 1 .
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278409_p5
PMC11278409
sec[1]/p[2]
2. Materials and Methods
4.082031
biomedical
Study
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[ 0.9921875, 0.005336761474609375, 0.0007076263427734375, 0.001651763916015625 ]
For each patient, the following data were collected: I. Pre-operative characteristics: baseline characteristics such as age, gender, laterality; clinical characteristics such as lens status, pre-operative BCVA (logMAR), ocular findings at dilated fundoscopy; and pre-operative OCT-based characteristics as detailed below. II. Surgical characteristics and intraoperative complications. III. Post-operative characteristics: post-operative BCVA (logMAR) and complications. The ETDRS (Early Treatment Diabetic Retinopathy Study) logMAR (logarithm of the Minimum Angle of Resolution) test was the standardized visual acuity test used to assess a patient’s pre- and post-operative vision.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999994
PMC11278409_p6
PMC11278409
sec[1]/sec[0]/p[0]
2.1. Surgical Technique
3.921875
biomedical
Study
[ 0.68017578125, 0.318359375, 0.0013980865478515625 ]
[ 0.568359375, 0.3486328125, 0.004734039306640625, 0.078369140625 ]
Patients with LMH were considered for surgery if they were symptomatic with significant metamorphopsia and/or worsening of BCVA or documented progression of LMH on the OCT. Small-gauge 25G PPV was performed in all cases. For all phakic patients, cataract surgery was concurrently performed. After vitrectomy, ERM and complete ILM peeling were completed. Air or 20% Sulfur-Hexafluoride (SF6) were used as intraocular tamponade depending on surgeon preference.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278409_p7
PMC11278409
sec[1]/sec[1]/p[0]
2.2. OCT Parameters
4.195313
biomedical
Study
[ 0.99853515625, 0.00131988525390625, 0.00014460086822509766 ]
[ 0.99658203125, 0.0019435882568359375, 0.0008950233459472656, 0.000370025634765625 ]
The OCT examination included a macular volume scan with a 49-line horizontal raster covering an area of 30° by 30° (approximately 125 µm spacing between each scan, depending on the axial length of the eye being examined) centered on the fovea. For each scan, two vitreoretinal experts evaluated the ellipsoid zone (EZ) and external limiting membrane (ELM) and classified them as “normal”, “disrupted” and “absent”. Subsequently, using the caliper tool present, the two vitreoretinal experts measured the minimum retinal thickness (MRT), defined as the smallest distance between the retinal pigment epithelium (RPE) and the inner border of the retinal tissue on the fovea on a line perpendicular to the RPE measured on the linear OCT scan dissecting the fovea; the minimum and maximal linear horizontal diameter of the foveal cavity (FC) in D-LMH and of the foveoschisis in ERM-FS defined as the shortest and longest distance measured horizontally across the foveal cavity or the foveoschisis on the linear OCT scan dissecting the fovea.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278409_p8
PMC11278409
sec[1]/sec[1]/p[1]
2.2. OCT Parameters
4.09375
biomedical
Study
[ 0.99951171875, 0.00022077560424804688, 0.00018477439880371094 ]
[ 0.9990234375, 0.0005774497985839844, 0.0002980232238769531, 0.00006985664367675781 ]
Since the OCT machine does not have the capacity to automatically segment and delineate specific LMH entities like FC in D-LMH, the volume of the schitic cavities described as schitic volume (SV) in ERM-FS, or epiretinal proliferation (ERP), we adopted a novel and manual technique to calculate the volumes of those specific entities, which was validated on healthy and pathological eyes . In brief, we calculate the surface area of the specific entity studied for each linear OCT scan . Finally, the specific volume was calculated by multiplying the sum of the areas by the distance between the horizontal b-scans, using the formula Volume (mm 3 ) = ∑area [mm 2 ] × OCT-scan distance [mm].
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278409_p9
PMC11278409
sec[1]/sec[1]/p[2]
2.2. OCT Parameters
4.144531
biomedical
Study
[ 0.99951171875, 0.0005779266357421875, 0.0001227855682373047 ]
[ 0.9951171875, 0.0039825439453125, 0.0008640289306640625, 0.00024366378784179688 ]
As the last step, after review of the correct OCT automized segmentation of the retinal layers, the following parameters, calculated by the OCT machine, were collected from the “Thickness Map” tablature of the OCT software (V 1.0): the central retinal thickness (CRT), defined as the average linear thickness in the central circle of the 1, 3, 6 ETDRS circle diameters; the central retinal volume (CRV), defined as the volume of the retinal tissue included in the 30° by 30° area scanned; the average ONL thickness, defined as the average thickness of the ONL included in the central circle of the 1, 3, 6 ETDRS circle diameters; and the volume of the ONL within a diameter of 1 mm centered in fovea, defined as the volume of the ONL included in the central circle of the 1, 3, 6 ETDRS circle diameters.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278409_p10
PMC11278409
sec[1]/sec[2]/p[0]
2.3. Statistical Analysis
4.089844
biomedical
Study
[ 0.9990234375, 0.0005345344543457031, 0.00023043155670166016 ]
[ 0.99951171875, 0.00030112266540527344, 0.00034046173095703125, 0.0000852346420288086 ]
The statistical analysis was executed using IBM SPSS Statistics for Windows, Version 29.0 (IBM Corp, Armonk, NY, USA). Statistical significance was defined as p < 0.05. First, continuous variables were estimated for normality using the Shapiro–Wilk test and the mean (standard deviation) was reported for normally distributed variables; otherwise, for skewed data, we reported the median (interquartile range). We performed a paired t -test between pre-operative and post-operative continuous variables. Fisher’s exact test was performed to compare nominal variables. To build a model of predictive factors from the initial OCT-based parameters, a multivariable linear regression analysis was conducted with post-operative BCVA (logMAR) as the dependent variable. The lens status, presence and volume of ERP, FC volume in D-LMH and SV in ERM-FS, CRV, foveal ONL volume and pre-operative BCVA (logMAR) were used for the regression model. To demonstrate the different effect of volumetric analyses on D-LMH and ERM-FS, we added interaction terms for foveal ONL volume, ERP volume and CRV as moderators. The 95% confidence interval and p values were generated following a 16,000 sample Wild Bootstrap. A Receiver Operating Characteristic (ROC) curve using Area Under Curve (AUC) analysis was performed to report on the sensitivity and specificity of a cut-off threshold based on pre-operative BCVA as a predictor for achieving ≤0.30 logMAR (6/12 Snellen) post-operatively.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278409_p11
PMC11278409
sec[2]/p[0]
3. Results
3.585938
biomedical
Study
[ 0.923828125, 0.0751953125, 0.0008573532104492188 ]
[ 0.98291015625, 0.00730133056640625, 0.0008821487426757812, 0.00904083251953125 ]
We include 31 eyes of 31 patients with LMH (14 D-LMH, 17 ERM-FS). The mean (standard deviation) age at presentation was 69 years old. Ten patients (32%) were males. Combined vitrectomy with cataract surgery was performed in all phakic patients, which resulted in 21 eyes (68%). No intra or post-operative complications were identified. The baseline and surgical characteristics are found in Table 1 .
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278409_p12
PMC11278409
sec[2]/sec[0]/p[0]
3.1. Pre-Operative Clinical Parameters and Visual Outcomes
4.179688
biomedical
Study
[ 0.99658203125, 0.0033130645751953125, 0.00031280517578125 ]
[ 0.99853515625, 0.0006175041198730469, 0.0005011558532714844, 0.0002548694610595703 ]
The median follow-up period was of 69 days. While in the D-LMH group, BCVA improved from 0.50 (0.24) logMAR pre-operatively to 0.42 (0.18) logMAR at last follow-up ( p = 0.056); in the ERM-FS group, BCVA improved from 0.49 (0.20) logMAR to 0.32 (0.20) logMAR ( p = 0.002). Across the whole cohort, mean pre-operative BCVA improved from 0.48 (0.22) logMAR to 0.36 (0.19) logMAR ( p < 0.001). Pre-operative and post-operative BCVA had a significant correlation . Regarding the potential confounding effect of cataract surgery on visual outcomes, we do not report significant differences in pre-operative ( p = 0.447), post-operative BCVA ( p = 0.195) or logMAR gain ( p = 0.643) between patients that were phakic ( n = 21) or pseudophakic ( n = 10) pre-operatively (see table, Supplementary Materials, Table S1 ). BCVA significantly improved in both patients that were phakic pre-operatively (from 0.47 [0.22] logMAR to 0.33 [0.16] logMAR) ( p = 0.003) and in patients that were pseudophakic preoperatively (from 0.53 [0.22] logMAR to 0.43 [0.24] logMAR) ( p = 0.049). Furthermore, we included pre-operative lens status as factor in our multivariate linear regression model and found that cataract surgery was not linked to significant improvement in post-operative BCVA ( Table 2 ).
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278409_p13
PMC11278409
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3.2. Pre-Operative OCT Parameters and Visual Outcomes
4.214844
biomedical
Study
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Using the univariate tests, worse pre-operative BCVA ( p < 0.001), presence of ERP ( p = 0.006), and increased SV in ERM-FS ( p = 0.008) were associated with worse functional outcomes after surgery ( Table 2 ). No statistically significant correlation was found with post-operative BCVA for the following: sex ( p = 0.241), age, lens status ( p = 0.195), CRT ( p = 0.212), MRT ( p = 0.100), ONL thickness ( p = 0.679), pre-operative status of EZ or ELM (respectively p = 0.097 and p = 0.447 for normal, p = 0.252 and p = 0.832 for disrupted and p = 0.339 and p = 0.141 for absent), and horizontal diameter of FC in D-LMH or foveoschisis in ERM-FS ( p = 0.166 for maximum, p = 0.337 for minimum horizontal diameter). With the multivariate linear regression model following a Wild Bootstrap (16,000 resamples), presence of ERP ( p = 0.002) and worse pre-operative BCVA ( p = 0.008) were confirmed as significantly associated with worse final visual function. Moreover, in the subtype of ERM-FS, a lower CRV ( p < 0.001) and ERP Volume ( p < 0.001), a higher SV ( p < 0.001) and foveal ONL volume ( p < 0.001) were significantly associated with worse visual outcomes after surgery. In the D-LMH subtype, increased FC volume ( p = 0.032) and lower CRV ( p = 0.034) were significantly associated with worse post-operative BCVA . The regression model could explain 88.8% of variability in post-operative BCVA (adjusted r 2 : 0.842). In contrast pre-operative BCVA alone could explain 44.4% of the variability in post-operative BCVA (adjusted r 2 : 0.425). Standardized Beta coefficients demonstrate the relative importance of each independent and moderator variable for post-operative BCVA (dependent variable). By reporting the standardized coefficients , we found that CRV in both subtypes and foveal ONL volume in ERM-FS were the most significant moderators in predicting post-operative BCVA.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278409_p14
PMC11278409
sec[2]/sec[1]/p[1]
3.2. Pre-Operative OCT Parameters and Visual Outcomes
4.09375
biomedical
Study
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[ 0.99951171875, 0.00014734268188476562, 0.000274658203125, 0.00006592273712158203 ]
A correlation matrix demonstrated that, at baseline, the increased volume of ERP strongly correlates to increased SV ( p = 0.005), reduced CRV ( p = 0.002) and foveal ONL volume ( p = 0.008), lower MRT ( p = 0.014) and ONL thickness ( p = 0.007). Among other correlations between the predictors determined in the study, only CRV showed correlation with ONL volume ( p < 0.001) ( Supplementary Materials, Table S2 ). Additionally, we found an association between low pre-operative BCVA and absence of pre-operative EZ ( p = 0.046) and presence of ERP with both poor pre- and post-operative BCVA ( p = 0.026 and p = 0.006, respectively) ( Supplementary Materials, Table S1 ).
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999999
PMC11278409_p15
PMC11278409
sec[2]/sec[1]/p[2]
3.2. Pre-Operative OCT Parameters and Visual Outcomes
4.152344
biomedical
Study
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Finally, through ROC curve and using AUC analysis, we determined a cut-off pre-operative BCVA of ≤0.48 logMAR as a predictor for achieving 0.30 logMAR at final follow up (sensitivity: 71.4%, specificity: 88.2%, AUC 0.828 [95% CI 0.681 to 0.974], p = 0.002, Youden Index [J]: 0.596) . While significance was maintained for eyes with pre-operative BCVA > 0.30 logMAR, there was no significant change in BCVA in patients with good pre-operative BCVA (<0.30 logMAR) ( p = 0.967). Eight (26%) of thirty-one eyes had 0.30 logMAR or better pre-operative BCVA, of which seven (88%) had maintained this post-operatively. However, among the twenty-three (84%) patients with pre-operative BCVA worse than 0.30 logMAR, eight (35%) achieved post-operative BCVA of 0.30 logMAR units or better. Despite having significantly larger logMAR gain ( p = 0.027), eyes with worse pre-operative BCVA had worse post-operative BCVA ( p = 0.002) .
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278409_p16
PMC11278409
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4. Discussion
4.082031
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Study
[ 0.99853515625, 0.0011625289916992188, 0.00018215179443359375 ]
[ 0.99853515625, 0.00047516822814941406, 0.0010204315185546875, 0.00017309188842773438 ]
We evaluated eyes that underwent vitrectomy with ERM/ILM peeling for LMH to investigate potential biomarkers of visual outcome. Surgical indications in eyes with LMH remain a controversial topic, mainly due to the contentious outcomes described following surgery . Indeed, improvement in BCVA and/or OCT-based foveal features (such as an increase in central retinal thickness or resolution of foveal defect) have been reported after surgery for LMH ; at the same time, caution has been advised by some when choosing surgery . Several studies have previously investigated the possible pre-operative predictors for surgical outcomes, but no consensus was achieved . Our choice to investigate OCT volumes is based on the concept that a volumetric analysis could better represent the retinal three-dimensional structural changes in LMH.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278409_p17
PMC11278409
sec[3]/p[1]
4. Discussion
4.128906
biomedical
Study
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We identified pre-operative BCVA as the main clinical parameter for final BCVA, explaining alone 44.4% of the variability in post-operative BCVA (r 2 : 0.444, adjusted r 2 : 0.425). This is consistent with previously described findings reporting a positive correlation between pre-operative BCVA and post-operative BCVA following LMH repair . In our study, BCVA significantly improved from 0.48 (0.22) before surgery to 0.36 (0.19) logMAR after surgery. Moreover, we identified a cut off of a pre-operative BCVA better than 0.48 logMAR as a predictor factor to achieve a post-operative BCVA of 0.30 logMAR or better (with a sensitivity of 71.4% and a specificity of 88.2%). However, we also showed that visual gain was particularly significant in eyes with pre-operative BCVA worse than 0.30 logMAR. These findings mean that, on one hand, patients with LMH have the best chance of keeping driving standard vision (0.30 logMAR) if surgery is carried out before the BCVA drops to 0.48 or worse; but on the other hand, early surgery might imply small or no visual gain and patients should be informed that, in some cases, early surgery just stabilizes visual acuity.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999999
PMC11278409_p18
PMC11278409
sec[3]/p[2]
4. Discussion
4.304688
biomedical
Study
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Our study confirmed the negative association between the presence of ERP and post-surgical visual outcome ( p = 0.006 and p = 0.020 for univariate and multivariate regression, respectively), as previously demonstrated in the scientific literature . Interestingly, in the D-LMH group, increased FC volume ( p = 0.032) and lower CRV ( p = 0.034) showed a correlation with worse post-operative BCVA. In the ERM-FS group, lower CRV ( p < 0.001) and ERP volume ( p < 0.001), increased SV ( p < 0.001) and higher foveal ONL volume ( p < 0.001) were all significant moderators associated with worse visual outcomes after surgery in the multivariate regression. Caution should be advised to not interpret these as main effects, but as significant moderators, to avoid a Table 2 fallacy error . In the scientific literature, only the study of Taşlıpınar Uzel et al. analyzed retinal volumes in the context of LMH, focusing on FC and ERP volumes in the natural history of D-LMH eyes that did not undergo surgery . Similarly to previous studies , Taşlıpınar Uzel et al. confirmed no correlation between vision and linear OCT measurements such as CRT in D-LMH, with FC volume the only factor associated with baseline BCVA on multivariate regression . CRV or ONL volume have never been investigated in the natural history, or correlated with surgical outcomes, in LMHs. To the best of our knowledge, this is the first report on pre-operative volumetric analysis of surgically treated LMHs. In the ERM-FS subtype, correlation between higher SV and worse visual outcome could be explained by the tractional forces of the ERM: larger SV might be present in more severe stages of the pathology with augmented tractional forces due to the ERM. Similarly, in D-LMH, we supposed that higher FC volumes reflect the increased degree of retinal tissue loss in the pathogenesis of the degenerative disease, indicating an advanced stage of the pathology and consequent worse visual outcomes after surgery. Moreover, smaller pre-operative CRV in our cohort (which correlates with larger SV in ERM-FS and higher FC in D-LMH) indicates a reduction in the viable retinal tissue and its volume , leading to poor functional outcomes post-surgery. We demonstrate that a higher foveal ONL volume is a negative moderator for post-operative BCVA in ERM-FS. We believe that this finding may appear consistent with what has been already demonstrated for idiopathic ERM . In the view of the causative association between tractional ERM and the development of foveoschisis in ERM-FS , we suggest that ERM-FS may share some characteristics with eyes affected by ERM, including the association between increased ONL volume and impaired visual function. In summary, the increased schisis and higher ONL volumes point to the increased tractional effect of ERM on the retinal tissue, with a possible effect on photoreceptors, which may explain worse functional outcomes post-surgery. In the D-LMH group, lower CRV ( p = 0.034) and higher FC volume ( p = 0.032), both indicating a greater loss of retinal tissue, had a correlation with reduced final vision.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278409_p19
PMC11278409
sec[3]/p[3]
4. Discussion
4.109375
biomedical
Study
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[ 0.99853515625, 0.0008826255798339844, 0.0003643035888671875, 0.00017344951629638672 ]
Vitrectomy combined with cataract surgery is a critical confounder in studies that report on visual outcomes following surgical intervention for LMH. In our cohort, we found that the combined phacovitrectomy group, relative to patients pseudophakic at baseline, gained an additional 0.03 logMAR, which was not significant. We report significant improvement in vision, whether the patient had cataract surgery, or was pseudophakic at baseline, without measured benefit to visual outcomes on the multivariate regression model by having cataract surgery. This is most likely due to our cohort of patients not having significant lenticular opacity at baseline and cataract surgery was primarily performed prophylactically with vitrectomy.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278409_p20
PMC11278409
sec[3]/p[4]
4. Discussion
4.015625
biomedical
Study
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[ 0.99951171875, 0.00020301342010498047, 0.0002789497375488281, 0.00008088350296020508 ]
We acknowledge that this study has several limitations, including its retrospective nature, the limited number of patients and a relatively short follow-up time. Nonetheless, we conducted a precise analysis of the asymmetric retinal morphology in LMHs by using a standardized OCT protocol. Finally, this is the first study, to our knowledge, to perform a volumetric analysis on eyes that underwent PPV for LMH and we presented a well-fitting robust regression model.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278409_p21
PMC11278409
sec[4]/p[0]
5. Conclusions
4.078125
biomedical
Study
[ 0.99951171875, 0.000576019287109375, 0.000148773193359375 ]
[ 0.9990234375, 0.000270843505859375, 0.0006165504455566406, 0.00012695789337158203 ]
In conclusion, our study highlights clinical and novel OCT volumetric biomarkers that correlate with post-operative BCVA following surgical intervention in LMHs. Although pre-operative BCVA was confirmed as a strong predictor of final visual outcome, the volumetric pre-operative independent variables included in our regression model offered a superior fit. We describe novel pre-operative OCT parameters significantly associated with visual outcomes following surgery such as CRV, ERP volume, SV and foveal ONL volume in ERM-FS, and CRV and FC volume in D-LMH. Further studies with larger numbers and longer post-operative follow-up can better investigate the role of volumetric analysis in the surgical treatment of lamellar macular holes.
[ "Myrta Lippera", "George Moussa", "Tsveta Ivanova", "Mariantonia Ferrara", "Karina Spiess", "Naseer Ally", "Kirti Jasani", "Felipe Dhawahir-Scala", "Niall Patton", "Assad Jalil" ]
https://doi.org/10.3390/jpm14070755
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278421_p0
PMC11278421
sec[0]/p[0]
1. Introduction
4.257813
biomedical
Review
[ 0.9873046875, 0.0092926025390625, 0.0032176971435546875 ]
[ 0.009857177734375, 0.0026798248291015625, 0.98681640625, 0.0008287429809570312 ]
Cervical radicular pain is a major problem worldwide, with an estimated annual incidence rate of 107.3 for males and 63.5 for females per 100,000 population, and it exerts an enormous personal and socioeconomic burden . One of the most common causes of radicular pain in the upper extremities is cervical disc herniation (CDH), the symptoms of which usually affect the quality of life, functional capacity, and sleep . The pathophysiology of cervical radicular pain is considered to be a combination of mechanical compression and chemical irritation of the nerve roots . In general, epidural injections through interlaminar and transforaminal routes are recommended if medical therapy, physical therapy, and lifestyle-modifying treatments have failed . To date, several trials have been performed to compare the effectiveness and safety of these two approaches, but debate remains as to which approach is superior to the other . Many physicians assert that fluoroscopy (FL)-guided transforaminal epidural steroid injection (TF-ESI) has the advantage of accurately delivering the injectate into the anterior epidural space, optimizing the concentration of medication at the site of pathology. On the basis of the current literature, there are reports of potentially serious complications such as spinal cord injury or vertebral artery dissection, even with strict guidelines . Additionally, severe complications such as epidural hematoma and spinal cord injury have raised concerns and questioned the prevailing belief that interlaminar cervical epidural steroid injection (IL-CESI) is safer than TF-ESI . As a result, controversy remains over the most optimal technique for cervical radicular pain due to safety concerns.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278421_p1
PMC11278421
sec[0]/p[1]
1. Introduction
3.925781
biomedical
Review
[ 0.99853515625, 0.0012369155883789062, 0.0002722740173339844 ]
[ 0.37841796875, 0.06365966796875, 0.5556640625, 0.0023708343505859375 ]
Recently, there has been a shift from FL to ultrasound (US) to guide interventional procedures . The major advantages of US guidance include real-time visualization and avoidance of radiation exposure. US-guided cervical selective nerve root block (CSNRB) is both a diagnostic and therapeutic approach used for cervical radicular pain. In CSNRB, the specific target is the affected nerve root, particularly the ventral ramus, located in the transverse process groove between the anterior and posterior tubercles. Unlike the FL-guided TF-ESI technique, in CSNRB, the needle is advanced to the extraforaminal area in order to avoid vascular structures within the foramen and is not intended to administer the medication into the epidural space . Recently, several research has shown the reliability and effectiveness of US-guided CSNRB .
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278421_p2
PMC11278421
sec[0]/p[2]
1. Introduction
4.027344
clinical
Other
[ 0.437255859375, 0.55517578125, 0.00756072998046875 ]
[ 0.07012939453125, 0.89794921875, 0.0034465789794921875, 0.0284423828125 ]
The primary objective of this prospective, randomized-controlled trial was to compare the effects of US-guided CSNRB versus FL-guided IL-CESI in patients with cervical radicular pain that persisted for at least three months due to single-level CDH on pain at six months after treatment. Patients with a history of previous cervical spine surgery, multi-level herniated disk, or multi-level cervical radicular pain were excluded from the study. Functional disability, quality of life, patient satisfaction, analgesic use, and procedure time comprised secondary outcomes.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278421_p3
PMC11278421
sec[1]/sec[0]/p[0]
2.1. Design
2.167969
clinical
Other
[ 0.1773681640625, 0.810546875, 0.01189422607421875 ]
[ 0.034210205078125, 0.95263671875, 0.0013113021850585938, 0.01197052001953125 ]
In accordance with the Helsinki Declaration, this trial was conducted as a prospective, randomized, assessor-blinded trial, and approval was obtained from the ethics committee of Diskapi Yildirim Beyazit Training and Research Hospital . All subjects provided written informed consent. The trial was registered on ClinicalTrials.gov in April 2022 . This trial was conducted between April 2022 and April 2023.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278421_p4
PMC11278421
sec[1]/sec[1]/p[0]
2.2. Patients
4
biomedical
Study
[ 0.80126953125, 0.197265625, 0.0013284683227539062 ]
[ 0.888671875, 0.0946044921875, 0.0026836395263671875, 0.0141143798828125 ]
Inclusion criteria were cervical radicular pain that persisted for at least 3 months, ≥18 years, unilateral single-level cervical radicular pain based on medical examination and confirmation of a single-level CDH via magnetic resonance imaging, numeric rating scale (NRS) score of ≥4, refractory pain after conservative treatment. Exclusion criteria were segmental instability/scoliosis/spondylolisthesis, body mass index ≥ 30 kg/m 2 , neuropsychiatric disease, epidural steroid injection within the past 6 months, previous cervical spine surgery, multi-level herniated disk, multi-level cervical radicular pain, neurological deficit, allergic reactions to contrast medium, pregnancy or contraindications to epidural injection. Patients were advised to continue taking their analgesics, if necessary, throughout the follow-up period.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278421_p5
PMC11278421
sec[1]/sec[2]/p[0]
2.3. Randomization and Blinding
3.232422
clinical
Other
[ 0.443359375, 0.55078125, 0.00608062744140625 ]
[ 0.1314697265625, 0.85107421875, 0.002349853515625, 0.01497650146484375 ]
A computer-generated randomization schedule was utilized for randomization . Patients were assigned a number and then allocated into two groups, with 30 patients in each group. Throughout the trial, the evaluator remained unaware of the randomization process, ensuring blinding.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278421_p6
PMC11278421
sec[1]/sec[3]/sec[0]/p[0]
2.4.1. IL-CESI Group
3.957031
clinical
Other
[ 0.263671875, 0.7333984375, 0.0030517578125 ]
[ 0.07000732421875, 0.46533203125, 0.006710052490234375, 0.4580078125 ]
The patient was positioned in the prone position with a pillow under the chest to raise the shoulders and flex the spine. After sterile cleaning and covering, 0.5–1 mL of 1% lidocaine was administered subcutaneously. Using a C-arm, an 18G tuohy needle was used to access the epidural space between C6, C7, and T1 via a paramedian approach. Once the needle was positioned just posterior to the spinolaminar line in lateral view, it was carefully advanced, and the ligamentum flavum was punctured using a loss-of-resistance technique. Confirmation of correct needle tip placement in the epidural space was confirmed through anteroposterior and lateral FL views, with contrast material flowing through the epidural space. Subsequently, a 3 mL drug was injected into the epidural space, comprising 2 mL of dexamethasone (8 mg) and 1 mL of 2% lidocaine.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278421_p7
PMC11278421
sec[1]/sec[3]/sec[1]/p[0]
2.4.2. CSNRB Group
4
biomedical
Study
[ 0.974609375, 0.024932861328125, 0.0006852149963378906 ]
[ 0.6240234375, 0.348388671875, 0.002185821533203125, 0.025604248046875 ]
The procedure was performed in the lateral decubitus position. A high-resolution (2–12 Hz) linear US probe was positioned transverse to the side of the neck, and the cervical tubercles were visualized. The nerve roots were identified by the anatomy of the transverse process; the C5th level has the same heights of anterior and posterior tubercles ; C6th level, the anterior tubercle is relatively taller, while the posterior tubercle is significantly shorter ; C7th has a prominent posterior tubercle and a rudimentary anterior tubercle .
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278421_p8
PMC11278421
sec[1]/sec[3]/sec[1]/p[1]
2.4.2. CSNRB Group
3.966797
clinical
Other
[ 0.4697265625, 0.52783203125, 0.0022945404052734375 ]
[ 0.16015625, 0.599609375, 0.0067901611328125, 0.233642578125 ]
After the cervical spine levels were determined, the US probe was tilted to clarify the target nerve root. The hypoechoic cervical spinal nerve can be identified in this view between the hyperechoic posterior and anterior tubercle. After performing subcutaneous local anesthetic, the needle was inserted from posterior to anterior using an in-plane approach to target the nerve root to the extraforaminal space. The target was directly posterior to the nerve root. A color doppler was performed to avoid penetration of vessels. After negative aspiration, 1 mL of 1% lidocaine as a test dose was administered to prevent intravascular injection, and the patient was monitored for 2–3 min. After verifying the absence of abnormal findings, 3 mL of solution (1 mL of 2% lidocaine, 2 mL of dexamethasone 4 mg/mL) was administered.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999999
PMC11278421_p9
PMC11278421
sec[1]/sec[4]/p[0]
2.5. Outcome Measurements
4.128906
biomedical
Study
[ 0.93994140625, 0.059295654296875, 0.0009050369262695312 ]
[ 0.97705078125, 0.0192108154296875, 0.0015697479248046875, 0.0022258758544921875 ]
Baseline data, including age, sex, and body mass index, were collected. Follow-up assessments were performed at months 1, 3, and 6 after the procedure. For evaluation of pain severity, patients were asked to report their average pain over the past week on the NRS . As a primary outcome measure, the NRS pain score was evaluated six months after treatment. Secondary outcomes included the percentage of successful responders (50% or greater improvement in NRS) and subjects who achieved a minimal clinically important difference (MCID) in NRS, functional status, quality of life, analgesic use, and patient satisfaction. The MCID for the NRS scores was determined by using threshold scores established in the previous studies: an improvement in NRS of at least 2 points .
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999999
PMC11278421_p10
PMC11278421
sec[1]/sec[4]/p[1]
2.5. Outcome Measurements
4.050781
biomedical
Study
[ 0.98974609375, 0.00969696044921875, 0.00041484832763671875 ]
[ 0.99560546875, 0.0032787322998046875, 0.0005359649658203125, 0.0004372596740722656 ]
Functional status was assessed with the neck disability index (NDI) . The Turkish version of the SF-36 was utilized to evaluate quality of life. The SF-36 provides the physical component summary (PCS) and the mental component summary (MCS) . To assess pain medication regimens and track changes, the quantitative analgesic questionnaire (QAQ) was performed . Overall satisfaction was assessed using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied) . Procedure time and side effects were also recorded. For CSNRB, this was the time from the moment the US probe touched the patient’s skin until the injection was completed. For IL-CESI, this was the time from obtaining the first radiographic image to completing the injection.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278421_p11
PMC11278421
sec[1]/sec[4]/p[2]
2.5. Outcome Measurements
4.070313
biomedical
Study
[ 0.9990234375, 0.0010776519775390625, 0.0001246929168701172 ]
[ 0.98828125, 0.00830078125, 0.002925872802734375, 0.000598907470703125 ]
The degree of compression of the nerve root established by Klessinger et al. was evaluated using T2-weighted axial MRI scans . According to this classification, grade I defines no contact between the disc and nerve root, and grade II defines disc contact to the nerve without displacement or compression. Grade III was assigned if the nerve root was displaced but not compressed, and grade IV indicates the compressed and morphologically distorted nerve root.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278421_p12
PMC11278421
sec[1]/sec[5]/p[0]
2.6. Sample Size Determination
4.089844
biomedical
Study
[ 0.998046875, 0.0016965866088867188, 0.00030493736267089844 ]
[ 0.99609375, 0.003612518310546875, 0.0002758502960205078, 0.00018274784088134766 ]
The sample size calculation was performed using G *Power software version 3.1.9.7 (Heinrich-Heine-Universität, Düsseldorf, Germany) based on the findings of a previous study. The mean NRS score was 3.9 ± 1.5 at 6 months after IL-CESI in that study . With the NRS as the primary outcome, a sample size of 25 patients was calculated to be required to detect a 30% difference, with a significance level of 0.05 and a power of 80%. Taking into account the potential loss of 20% of patients during the follow-up period, a sample size of 30 patients was established for each group.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999999
PMC11278421_p13
PMC11278421
sec[1]/sec[6]/p[0]
2.7. Statistical Analysis
3.964844
biomedical
Study
[ 0.99951171875, 0.0003666877746582031, 0.00026416778564453125 ]
[ 0.998046875, 0.001445770263671875, 0.00043082237243652344, 0.00008666515350341797 ]
Statistical analysis was performed with IBM SPSS Statistics version 20. Continuous variables were reported as mean with standard deviation or median with interquartile range, while categorical variables were reported as counts and percentages. The normal distribution of the data was assessed using the Shapiro–Wilk test. The χ 2 test or Fisher exact test was used to compare categorical variables. For non-normally distributed data, the Mann–Whitney U test was used for comparison, while the independent t-test was used for normally distributed data. Two-way repeated measures analysis of variance was used to determine changes from baseline for variables at each time point within and between groups, with post-hoc Bonferroni tests. A p -value of <0.05 was considered statistically significant.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999999
PMC11278421_p14
PMC11278421
sec[2]/p[0]
3. Results
3.300781
biomedical
Study
[ 0.93017578125, 0.06817626953125, 0.0017957687377929688 ]
[ 0.9287109375, 0.0660400390625, 0.0011968612670898438, 0.004024505615234375 ]
In this study, 60 patients were randomly allocated to the treatment groups. No significant differences were observed between the groups in baseline demographic data or severity of nerve root compression ( p > 0.05) ( Table 1 ).
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278421_p15
PMC11278421
sec[2]/p[1]
3. Results
4.15625
biomedical
Study
[ 0.998046875, 0.0013933181762695312, 0.0003170967102050781 ]
[ 0.9990234375, 0.00046896934509277344, 0.0002651214599609375, 0.00011229515075683594 ]
The group allocation did not have a significant effect on the NRS scores within groups [F (1, 58) = 0.687, p = 0.411], as well as on the NDI scores [F (1, 58) = 0.838, p = 0.364] ( Table 2 ). A significant effect of time was found in the NRS [F (2.57, 149.27) = 211.257, p < 0.001] and NDI [F(2.033, 117.938) = 103,097, p < 0.001] in both groups. No significant interaction was presented between time and group allocation for NRS [F(2.57, 149.27) = 0.658, p = 0.556] and NDI [F(2.033, 117.938) = 0.251, p = 0.782] scores ( Table 2 and Table 3 ).
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278421_p16
PMC11278421
sec[2]/p[2]
3. Results
4.144531
biomedical
Study
[ 0.97314453125, 0.02618408203125, 0.0006480216979980469 ]
[ 0.986328125, 0.0111236572265625, 0.0012416839599609375, 0.0012292861938476562 ]
Both treatment groups showed significant improvement in NRS, NDI, and SF-36 scores at each follow-up point during the six months compared with pre-intervention ( p < 0.001) ( Table 3 ). Treatment success, defined as the percentage of patients experiencing more than 50% pain reduction, was achieved in 56.6% ( n = 17) of the IL-CESI group and 50% ( n = 15) of the CSNRB group at the end of the study. At month 6, it was observed that 86.7% (26 out of 30) of patients in the IL-CESI group experienced an MCID in NRS compared with 83.3% (25 out of 30) in the CSNRB group. However, no significant difference was found between the groups ( Table 2 ).
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278421_p17
PMC11278421
sec[2]/p[3]
3. Results
4.144531
biomedical
Study
[ 0.98486328125, 0.0147857666015625, 0.0005807876586914062 ]
[ 0.99658203125, 0.0021305084228515625, 0.0007233619689941406, 0.0005311965942382812 ]
In both groups, a significant decrease in analgesic use was observed at six months in comparison with baseline ( p < 0.001). Among the patients who underwent IL-CESI and CSNRB, 80% and 73.3% reported being very satisfied or satisfied, respectively. However, no significant differences were found between the groups ( p > 0.05). Procedure time was significantly shorter in the US-guided CSNRB (352.42 ± 103.61) than in the FL-guided IL-CESI (208.76 ± 96.2) ( p < 0.001) ( Table 3 ).
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278421_p18
PMC11278421
sec[2]/p[4]
3. Results
4.082031
biomedical
Study
[ 0.8935546875, 0.1051025390625, 0.0013151168823242188 ]
[ 0.96533203125, 0.027435302734375, 0.0015363693237304688, 0.0054779052734375 ]
The manifestation of blood aspiration before injection was observed in three patients in the FL-guided group but in none in the US-guided group. Intravascular contrast spread during injection was observed in two patients of the FL-guided group. For US-guided CSNRB, an additional contrast agent was not performed to detect intravascular spread with FL. Adverse events immediately after the procedure, such as dizziness, nausea, vomiting, and vasovagal reactions, were observed in three patients (10%) and four patients (13.3%) in the US group and FL group, respectively ( p = 0.687). No serious complications, such as infection, hematoma, or motor deficit, were observed.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278421_p19
PMC11278421
sec[3]/p[0]
4. Discussion
4.128906
biomedical
Study
[ 0.98681640625, 0.01293182373046875, 0.0004470348358154297 ]
[ 0.9951171875, 0.003047943115234375, 0.0011882781982421875, 0.0007977485656738281 ]
The present study investigated the efficacy of US-guided CSNRB versus FL-guided IL-CESI in unilateral cervical radicular pain due to a single-level CDH. The results of this study suggest that US-guided CSNRB is a feasible alternative treatment option. Patients in both groups showed similar treatment outcomes in terms of pain relief, functional disability, quality of life, and pain medication consumption over six months. The proportion of subjects who experienced an MCID and a positive treatment outcome on the NRS was not statistically different between the groups. However, procedure time was higher in the IL-CESI group.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278421_p20
PMC11278421
sec[3]/p[1]
4. Discussion
4.175781
biomedical
Review
[ 0.99072265625, 0.00676727294921875, 0.002307891845703125 ]
[ 0.017974853515625, 0.00506591796875, 0.97607421875, 0.0008459091186523438 ]
ESI through interlaminar and transforaminal routes under FL guidance is an effective approach to close the gap between conservative treatment modalities and cervical spine surgery in cervical radicular pain, but a debate is still ongoing about the superiority of one over the other. Generally, physicians avoid performing IL-CESI over IL-lumbar ESI because the cervical epidural area anatomy is somewhat different. The cervical epidural space has the smallest size among all spinal levels . Additionally, epidural fat is unevenly distributed and almost non-existent at the cervical level . TF-ESI is a more targeted-selective treatment option for cervical radicular pain. However, the anatomical proximity between the vertebral arteries and the cervical neuroforamen plays a significant role in injury to the vertebral arteries or the occurrence of neurologic complications . Additionally, the TF-ESI technique does not reduce the risk of potentially serious complications attributed to IL-CESI, such as hematoma and subdural or dural punctures . The role cervical ESI plays across a spectrum of resolution of radicular symptoms is clear and well documented. However, challenges remain regarding the translation of these substantial benefits into a safer treatment approach.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278421_p21
PMC11278421
sec[3]/p[2]
4. Discussion
3.984375
biomedical
Study
[ 0.99853515625, 0.0010690689086914062, 0.00021088123321533203 ]
[ 0.49658203125, 0.068359375, 0.432373046875, 0.00257110595703125 ]
Recently, there has been a shift from FL to US for guiding spinal procedures, as the latter can provide direct-time visualization and can help confirm the location of nerves, vessels, and injections. This advantage is particularly valuable for cervical interventions, as this area contains numerous vulnerable vessels and vital structures, and the path of the needle during injection often crosses these structures. Considering these safety concerns, US imaging is a safe and reliable technique for CSNRB to provide well-defined images of the cervical neuroforamen with continuous visualization, which could decrease the reported complications. In US-guided CSNRB, the needle is placed in the intertubercular neural groove between the anterior and posterior tubercles of the cervical vertebra outside the foramen of the affected nerve without entering the epidural space. After the initial description of the US-guided CSNRB, priorities for research include treatment outcomes and complications in cervical radicular pain.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278421_p22
PMC11278421
sec[3]/p[3]
4. Discussion
4.085938
biomedical
Study
[ 0.99853515625, 0.0010919570922851562, 0.0002739429473876953 ]
[ 0.994140625, 0.0005016326904296875, 0.00527191162109375, 0.000171661376953125 ]
In the present study, no difference in treatment outcomes was found regarding improvement in pain relief, quality of life, and functional capacity during the follow-up period when the US-guided CSNRB and FL-guided IL-CESI were compared. In a prospective randomized study, Jee et al. investigated the efficacy of US-guided CSNRB versus FL-guided TF-ESI in cervical radicular pain. They reported that the US-guided CSNRB provided similar improvement in pain scores and functional disability during the 3-month follow-up period as the FL-guided approach . In another retrospective study, Jang et al. evaluated the effectiveness of FL-guided CESI and TF-ESI and US-guided CSNRB. The findings of their trial showed that the outcomes of the three procedures were similar in terms of pain relief, improvement in functionality, and reduction in the percentage of analgesic users during the 6-month follow-up . In a retrospective comparative study, Park et al. showed that US-guided CSNRB provides a similar improvement in pain scores and functional disability as FL-guided IL-CESI . To the best of our knowledge, no previous prospective randomized controlled studies have investigated the effects of US-guided CSNRB on pain medication consumption, patient satisfaction, and functional improvement. Additionally, there have been no comparisons using the aforementioned parameters between US-guided CSNRB and FL-guided CESI. Based on the literature, including this study, US-guided CSNRB can be an alternative treatment modality in cervical radicular pain due to its similar effects to FL-guided procedures.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278421_p23
PMC11278421
sec[3]/p[4]
4. Discussion
4.089844
biomedical
Study
[ 0.99853515625, 0.0010986328125, 0.00020325183868408203 ]
[ 0.99267578125, 0.0006284713745117188, 0.006366729736328125, 0.00023758411407470703 ]
Although there is no standardization, injection volumes between 1 and 4 mL are recommended for CSNRB. In the context of CSNRB, while it is presumed that spread is limited to the targeted nerve root and does not result in an unexpected epidural block at other spinal levels, high volume, low viscosity, technical factors, hydrostatic pressure, and osmotic effects, an extension of dural sleeve into the foramen may result in neuraxial spread. Recently, Ma et al. investigated injection spread patterns of US-guided CSNRB with a 3 mL injection. They reported that contrast spread into the extraforaminal area in 100% of patients and to the intraforaminal area in 61.90% of patients on post-procedure CT scan images, and finally to the epidural spaces in only 9.52%, with contrast spread limited to the corresponding cervical level . In another study, Kang et al. investigated the spread pattern related to injection volume. The study revealed that none of the patients who had received a 1 mL injection of contrast medium exhibited diffusion into the epidural area, whereas 13 subjects (24.5%) who had received a 4 mL injection showed diffusion into the intraforaminal epidural area . However, there was no relationship between the improvements in pain scores and the spread pattern of contrast. In this study, a 3 mL treatment drug was chosen according to our routine clinical practice. Similar to our results, two retrospective studies demonstrated that US-guided CSNRB performed with a 3 mL injection consisting of dexamethasone and lidocaine is effective for cervical radicular pain for up to 6 months .
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278421_p24
PMC11278421
sec[3]/p[5]
4. Discussion
4.121094
biomedical
Study
[ 0.990234375, 0.00949859619140625, 0.0002841949462890625 ]
[ 0.99462890625, 0.0033931732177734375, 0.00092315673828125, 0.0009522438049316406 ]
The use of ultrasound is beneficial in identifying atypical vessels that may be located unexpectedly proximal to the intervertebral foramen. However, it may not be able to detect intravascular injections. In this present study, color Doppler US, a non-particulate steroid, and a test dose by administering one mL of 1% lidocaine prior to US-guided CSNRB were performed to prevent potential complications associated with intravascular injection. During the FL-guided CESI procedure, intravascular injection and blood aspiration before injection were identified in two and three patients, respectively. However, blood aspiration before injection was not noted during the US approach. Although we did not use an additional contrast agent with FL to confirm the appropriate injection of the medication during US-guided CSNRB, we found no intravascular events associated with the procedure, which is in line with the findings of previous studies . It is important to note that the US may not always reliably detect microvascular injections, which can potentially result in neurological complications. Therefore, it is still necessary to exercise caution when using current US technology to confirm the absence of small critical vessels. As a result, we suggest performing a lidocaine test, color Doppler, and non-particulate steroids to support the safety of the US approach.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278421_p25
PMC11278421
sec[3]/p[6]
4. Discussion
4.121094
biomedical
Study
[ 0.99755859375, 0.0024013519287109375, 0.00025463104248046875 ]
[ 0.998046875, 0.0008645057678222656, 0.0006456375122070312, 0.00021958351135253906 ]
The findings of this study favored US-guided CSNRB over FL-guided IL-CESI in terms of procedure time, which is consistent with previous reports . Many physicians may encounter difficulties in accessing FL devices and shielding leads in operating rooms. US assistance not only allows radiation-free imaging and shorter procedure times but also offers advantages in terms of greater portability and affordability over FL. On the other hand, it is important to note that this study included subjects with unilateral single-level cervical radicular pain due to single-level CDH. When IL-CESI is performed, the injection results in the blockade of nerve roots at other levels. Therefore, in patients with bilateral cervical radicular pain or patients with pain in more than one dermatomal distribution, safety concerns and procedure time must be taken into account when performing a US-guided CSNRB.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999994
PMC11278421_p26
PMC11278421
sec[3]/p[7]
4. Discussion
4.214844
biomedical
Study
[ 0.99072265625, 0.008697509765625, 0.0003581047058105469 ]
[ 0.99365234375, 0.004375457763671875, 0.0009703636169433594, 0.0007905960083007812 ]
It is important to acknowledge some limitations of this study. First, the trial was not designed as a double-blinded study; it is challenging to conduct a double-blinded study with imaging devices such as US or FL. Further research comparing these imaging techniques could ensure blinding by scanning patients with a mock US. Second, different NRS scores could be used for neck and arm pain. Third, the sample size is relatively small, and the study’s follow-up period was of short duration, specifically limited to a six-month post-treatment evaluation period. Fourth, the results could have been strengthened if contrast spread to the affected nerve root during US-guided CSNRB had been verified. Fifth, the treatment procedures were performed by a single physician, and the physician’s experience in obtaining good images and safely directing the needle to the target point may have influenced our results. Sixth, it was hypothesized that pain relief might last longer in patients following ESI of particulate steroids compared to non-particulate steroids. We used dexamethasone based on previous studies and discussion among the authors of this study to provide similarity between groups, although there is no evidence to suggest that using non-particulate dexamethasone offers any safety advantage over particulate steroids . Seventh, the natural course of cervical radiculopathy is difficult to outline. Due to the absence of a placebo/sham group, we can not exclude the natural course of the disease or the placebo effect of the treatments. It is worth noting that the prevalence of placebo and nocebo effects in the context of interventional treatments is estimated to range between 13% and 30% and 3% and 8%, respectively . Within the scope of this study, it is important to emphasize that all enrolled patients had not responded to conventional therapeutic modalities. Considering these observations and the inherently progressive and degenerative nature of refractory chronic radicular pain, we assert that the pain experienced by our patients has reached a plateau. Finally, the US approach was performed in patients with a BMI less than 30 kg/m 2 . Visualization of small vessels such as radicular arteries may be very difficult, especially in obese patients.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278421_p27
PMC11278421
sec[4]/p[0]
5. Conclusions
3.710938
biomedical
Study
[ 0.998046875, 0.0017032623291015625, 0.00033926963806152344 ]
[ 0.98291015625, 0.01445770263671875, 0.0021533966064453125, 0.0006051063537597656 ]
The US-guided CSNRB was shown to be as effective as the FL-guided IL-CESI in the treatment of cervical radicular pain, in addition to the absence of radiation exposure and requiring less procedure time. Future studies are needed to investigate the potential of US-guided CSNRB and confirm or refute the findings of this study.
[ "Halil Cihan Kose", "Selin Guven Kose", "Feyza Celikel", "Serkan Tulgar", "Omer Taylan Akkaya" ]
https://doi.org/10.3390/jpm14070721
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278433_p0
PMC11278433
sec[0]/sec[0]/p[0]
1.1. Background
4.277344
biomedical
Review
[ 0.99755859375, 0.001251220703125, 0.0010232925415039062 ]
[ 0.077392578125, 0.055999755859375, 0.86474609375, 0.0016698837280273438 ]
Non-steroidal anti-inflammatory drugs (NSAIDs) are medicines groups that have analgesic, anti-inflammatory, and antipyretic properties . Their therapeutic effect as well as the risk of side effects result from the inhibition of cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2) . COX-1 is constantly present in the human body, and its action involves the synthesis of compounds such as prostaglandins and thromboxane, which play several important roles in the organism . Prostaglandins are responsible, among other things, for creating the protective barrier of the stomach by reducing the production of hydrochloric acid and stimulating gastric mucus secretion . Therefore, inhibiting the production of prostaglandins promotes the development of erosions in the digestive tract and the risk of bleeding . The role of thromboxane is mainly vasoconstriction and platelet aggregation; thus, coagulation disorders may be a side effect of using NSAIDs . The increased production of COX-2 occurs as a result of inflammation and its activation causes the symptoms that characterize it, such as redness, swelling, pain, increased temperature, and tissue function disorders. Therefore, NSAIDs may soothe the ailments mentioned above .
[ "Filip Bliźniak", "Maciej Chęciński", "Kamila Chęcińska", "Karolina Lubecka", "Monika Kamińska", "Mariusz Szuta", "Dariusz Chlubek", "Maciej Sikora" ]
https://doi.org/10.3390/jcm13144056
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278433_p1
PMC11278433
sec[0]/sec[0]/p[1]
1.1. Background
4.097656
biomedical
Review
[ 0.99462890625, 0.0033893585205078125, 0.0019130706787109375 ]
[ 0.019989013671875, 0.11090087890625, 0.8671875, 0.0017070770263671875 ]
NSAIDs are a large group of drugs classified primarily due to their effect on cyclooxygenases: (1) inhibiting both COX-1 and COX-2 or (2) suppressing primarily COX-2 . Preparations that inhibit COX-1 and COX-2 include, among others, ketoprofen, acetylsalicylic acid, indomethacin, nabumetone, ibuprofen, piroxicam , tenoxicam , meloxicam, diclofenac , naproxen, and nimesulide . In turn, drugs that selectively suppress COX-2 are primarily coxibs . These drugs can be administered orally (e.g., in the form of tablets, sachets, and syrups), rectally (suppositories), intravenously, intramuscularly, and in the form of creams, gels, and patches . Depending on the classification of NSAIDs, their doses, or the dosing method, they exert both therapeutic effects and potential side effects with varying intensity .
[ "Filip Bliźniak", "Maciej Chęciński", "Kamila Chęcińska", "Karolina Lubecka", "Monika Kamińska", "Mariusz Szuta", "Dariusz Chlubek", "Maciej Sikora" ]
https://doi.org/10.3390/jcm13144056
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278433_p2
PMC11278433
sec[0]/sec[0]/p[2]
1.1. Background
3.945313
biomedical
Review
[ 0.99755859375, 0.0017671585083007812, 0.0009007453918457031 ]
[ 0.035308837890625, 0.07086181640625, 0.892578125, 0.0013570785522460938 ]
Joint pain may be related to overload, or injury, but also result from the existence of a rheumatological disease, such as rheumatoid arthritis, systemic sclerosis, juvenile idiopathic arthritis, dermatomyositis, polymyositis, and systemic lupus erythematosus . These diseases are among the diseases with chronic tissue inflammation and emerging pain . In intra-articular injection therapy, mainly blood products, hyaluronic acid, and drugs are used . The choice of NSAIDs potentially should reduce the exacerbation of inflammation and, consequently, relieve pain, which is one of its determinants. Scientific research has already addressed the issue of the intra-articular administration of NSAIDs, e.g., to the knee or hip joints. The indications for such treatment are relieving symptoms in orthopedic and rheumatological diseases and preventing complications associated with other administration routes .
[ "Filip Bliźniak", "Maciej Chęciński", "Kamila Chęcińska", "Karolina Lubecka", "Monika Kamińska", "Mariusz Szuta", "Dariusz Chlubek", "Maciej Sikora" ]
https://doi.org/10.3390/jcm13144056
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999996
PMC11278433_p3
PMC11278433
sec[0]/sec[0]/p[3]
1.1. Background
4.085938
biomedical
Study
[ 0.9990234375, 0.0009217262268066406, 0.00027823448181152344 ]
[ 0.99560546875, 0.0005931854248046875, 0.00371551513671875, 0.0001811981201171875 ]
Temporomandibular disorders (TMDs) manifest themselves, among others, with pain, limited mobility, and acoustic symptoms in the temporomandibular joints (TMJs) . Secondary TMJ pain is attributed to arthritis, disc displacement, osteoarthritis, or subluxation. This paper focuses on the first three causes because subluxation is treated using other means, with particular attention to reducing jaw abduction and reducing the frequency of dislocation episodes. Recent reports indicate that TMDs affect between 5% and 12% of the population . They also present a gender predilection, affecting women on average four times more often than men, although the reason for this has not yet been clearly established . Based on research conducted among the population of the north-east of England, the cost of TMD treatment for a 6-month period is between EUR 379 and EUR 613 per person, which are mainly the costs of specialist consultations .
[ "Filip Bliźniak", "Maciej Chęciński", "Kamila Chęcińska", "Karolina Lubecka", "Monika Kamińska", "Mariusz Szuta", "Dariusz Chlubek", "Maciej Sikora" ]
https://doi.org/10.3390/jcm13144056
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998
PMC11278433_p4
PMC11278433
sec[0]/sec[0]/p[4]
1.1. Background
3.892578
biomedical
Review
[ 0.99609375, 0.0022144317626953125, 0.001495361328125 ]
[ 0.00942230224609375, 0.00786590576171875, 0.982421875, 0.0005006790161132812 ]
Several methods lead to relieve symptoms of TMDs, including physiotherapy, pharmacotherapy, splint therapy, and surgery . The latter have a wide range of invasiveness, from single injections, through a series of administrations, two-needle arthrocentesis, and arthroscopy, to open surgery and even joint replacement with a prosthesis . Intra-articular injections, as a minimally invasive surgical procedure combining the mechanical action of the administered fluid with the pharmacological action of the substance contained in it, have been the subject of many clinical studies summarized in systematic reviews . Substances less frequently represented in the literature are still awaiting the synthesis of primary research results.
[ "Filip Bliźniak", "Maciej Chęciński", "Kamila Chęcińska", "Karolina Lubecka", "Monika Kamińska", "Mariusz Szuta", "Dariusz Chlubek", "Maciej Sikora" ]
https://doi.org/10.3390/jcm13144056
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999995
PMC11278433_p5
PMC11278433
sec[0]/sec[1]/p[0]
1.2. Rationale
3.357422
biomedical
Review
[ 0.99658203125, 0.0010519027709960938, 0.002399444580078125 ]
[ 0.03070068359375, 0.018798828125, 0.94970703125, 0.0006337165832519531 ]
There are increasing scientific articles on NSAIDs administered into the TMJs via injection . Initial searches revealed that reports from clinical studies support the validity of such a procedure. However, the results of treatment with intra-articular NSAIDs require verification at a level higher than a single trial. The preliminary searches did not identify any systematic review specifically aimed at assessing the effectiveness of NSAID administration in the TMJ cavities. Broader reviews published to date only briefly address the topic of NSAIDs .
[ "Filip Bliźniak", "Maciej Chęciński", "Kamila Chęcińska", "Karolina Lubecka", "Monika Kamińska", "Mariusz Szuta", "Dariusz Chlubek", "Maciej Sikora" ]
https://doi.org/10.3390/jcm13144056
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999997
PMC11278433_p6
PMC11278433
sec[0]/sec[2]/p[0]
1.3. Objective
4.007813
biomedical
Review
[ 0.99072265625, 0.006008148193359375, 0.003292083740234375 ]
[ 0.0089111328125, 0.0035762786865234375, 0.98681640625, 0.0006585121154785156 ]
This systematic review aims to synthesize the randomized controlled trial evidence on NSAID intra-articular administration into the TMJ cavity.
[ "Filip Bliźniak", "Maciej Chęciński", "Kamila Chęcińska", "Karolina Lubecka", "Monika Kamińska", "Mariusz Szuta", "Dariusz Chlubek", "Maciej Sikora" ]
https://doi.org/10.3390/jcm13144056
N/A
https://creativecommons.org/licenses/by/4.0/
en
0.999998