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Author contributions | This study was designed by P.C.C., O.K., D.S., and E.H. Data collection was carried out by P.C.C.. Data analysis was carried out by P.C.C.. Interpretation of data was done by P.C.C., O.K., D.S., and E.H. Writing of the paper was done by P.C.C. Supervision was done by O.K., D.S., and E.H. All authors read and approved the final manuscript. | PMC10603062 | ||
Funding | DER | This work was funded by Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (Grant no. P0GEP1_175061). | PMC10603062 | |
Data availability | Data used in the present study is publicly available at | PMC10603062 | ||
Competing interests | The authors declare no competing interests. | PMC10603062 | ||
References | PMC10603062 | |||
1. Introduction | death | REGRESSION | People who smoke often make several quit attempts before successfully maintaining abstinence. Therefore, incorporating re-engagement for people who fail to initially quit could increase quit attempts and ultimately increase cessation rates. Within the context of quit line-based interventions, it remains unknown what characteristics are associated with re-engagement. The purpose of this study was to assess associations between demographic and motivational characteristics, tobacco use, and initial intervention engagement with re-engagement in a tobacco quit line intervention. Among 372 adults who reported smoking three months after initiating a quit line-facilitated quit attempt as part of a larger randomized clinical trial, associations between personal characteristics (e.g., age, gender, nicotine dependence, and confidence in their ability to quit smoking) and initial intervention engagement (number of completed counseling sessions and use of nicotine replacement therapy (NRT)) with re-engagement (accepting an offer to re-initiate the quit line intervention) were determined using multivariable logistic regression modeling. Compared to non-White participants, White participants had lower odds of re-engaging (OR: 0.42, 95% CI: 0.23, 0.75). Number of initial counseling sessions completed was associated with re-engaging. NRT use during the initial intervention was not associated with re-engaging. Initial intervention engagement is important in the process of re-engagement, specifically attending counseling sessions. Exploration of associations between initial intervention engagement and potentially modifiable motivational factors is needed to be potentially leveraged in future interventions to maintain continued engagement in cessation among adults who smoke.Cigarette smoking remains the leading cause of preventable death in the US [To inform tailoring strategies, the characteristics of people who smoke who are interested in re-engaging following a failed quit attempt need to be identified. Insight concerning who is likely to re-engage may enable resource-limited quit lines to target outreach strategies for maximum re-engagement. To our knowledge, two previous studies have examined predictors of re-engagement in a tobacco quit line. Using data from the Arizona Quit line, Nair et al. found that individuals who chose to re-engage had higher odds of both mental health and chronic health diagnoses [Thus, the previous literature has assessed associations between demographic characteristics, tobacco use characteristics, and the initial mode of intervention with re-engagement. However, the paucity of research in this area warrants continued evaluation. Further, there remain additional areas for investigation that have not been previously considered. Specifically, it is unclear if engagement in the initial intervention, or interactions between use of initial intervention components (e.g., attending counseling sessions and using NRT) influence re-engagement. It is also unknown if confidence in quitting or reasons for quitting influence re-engagement. Consequently, this study sought to assess the association between demographic and motivational characteristics, tobacco use, and initial intervention engagement with re-engagement in a tobacco quit line intervention. | PMC9859567 |
2. Materials and Methods | PMC9859567 | |||
2.1. Data and Study Population | SECONDARY | This is a secondary data analysis from a large clinical trial of 612 adults who smoke designed to determine the efficacy of three re-engagement strategies on long-term (12 months) smoking cessation [ | PMC9859567 | |
2.2. Measures | The primary outcome of interest was the participant’s decision to re-engage at three months (yes vs. no) based on responses to the three-month follow-up assessment, thereby making another quit line-facilitated quit attempt, or to decline the opportunity to re-engage, including overt decline to re-engage (Several independent variables of interest were included, which were all measured at the baseline assessment. Nicotine dependence was assessed using the Fagerström Test for Nicotine Dependence [ | PMC9859567 | ||
2.3. Statistical Analyses | REGRESSION | All analyses were performed using SAS 9.4 (SAS, Cary, NC, USA). Continuous variables were summarized using median and interquartile range and compared between participants who re-engaged vs. did not re-engage a using Wilcoxon rank sum test. Categorical variables were summarized using frequency and percentages and compared by re-engagement status using Fisher’s exact test. A multivariable logistic regression model to determine correlates of re-engagement (outcome referent = did not re-engage) was created, which included any independent variable of interest found to be associated with re-engagement in the univariate statistics using a cut-off of | PMC9859567 | |
3. Results | Among participants who did not re-engage, the majority were male (56.7%), White (83.1%), married or partnered (65.6%), and active duty or retired military (63.9%, Primary Results: Multivariable results indicated that race, baseline confidence in quitting, and initial counseling sessions completed were associated with re-engagement ( | PMC9859567 | ||
4. Discussion | SECONDARY | The purpose of this study was to identify interpersonal and intervention use characteristics associated with re-engagement among adults participating in a quit line intervention study. To our knowledge, this study is the first to consider personal, tobacco use, motivation, and initial intervention utilization factors that may be associated with re-engagement in a quit line intervention. We found that, among all possible characteristics of interest, non-White race and high levels of baseline confidence in quitting were associated with re-engagement at three months. Engagement with the initial intervention was also associated with re-engagement, specifically the number of initial counseling sessions completed. These results provide new information about why some adults who smoke who fail to quit may ultimately choose to re-engage in a quit line intervention, establishing new potential directions for future studies.Some studies have attempted to increase re-engagement in quit line services among adults who smoke who initially fail to quit. For example, Vickerman et al. randomized callers to the Minnesota Quit Line into receiving or not receiving re-engagement outreach [We also identified previously unconsidered motivational factors that were associated with re-engagement at three months. Specifically, participants with higher levels of baseline confidence in quitting were more likely to re-engage at three months, which was roughly 6 weeks after the initial intervention ended. It is noteworthy that baseline confidence would produce such an effect, especially within a sample of adults who were all unsuccessful in their first quit attempt. It is possible that increasing confidence in quitting by providing motivational messages by counselors early in quit line counseling may increase their engagement in the initial intervention as well as the likelihood that those still smoking after their initial quit attempt will subsequently be open to re-engagement. Tangentially, Danaher et al. found that positive changes in ratings on a five-point Likert scale of one’s confidence of being tobacco-free in 1 year mediated the relationship between a web-based tobacco intervention and abstinence at 3- and 6-month follow-up [Our finding that participants who completed more initial intervention quit line counseling sessions had increased odds of re-engagement with the quit line intervention suggests that increasing initial intervention engagement could be a promising strategy to maximize re-engagement following an unsuccessful quit attempt. To our knowledge, no studies have sought to bolster initial engagement of quit line callers with the goal of improving chances of eventual re-engagement intervention. Beebe et al. (2020) found that selection of a less intensive option by callers for their initial intervention predicted increased likelihood of re-engagement [This study estimated the effect of initial intervention engagement on re-engagement at three months independent of baseline motivational factors such as confidence in quitting some day and specific reasons for quitting smoking, including quitting to be a good role model and quitting to control one’s life. Nevertheless, there remains a potential that motivation has an influence on both initial intervention engagement and interest in re-engagement after relapse. Due to missing data at three months, we were not able to consider motivational items at the time of re-engagement. However, descriptively at three months, a higher percentage of participants who chose to re-engage reported seeing extreme benefit in quitting for their health (65.6% vs. 49.3% for re-engaged and non-re-engaged, respectively, This study has several limitations that need to be considered. First, these results are from a secondary analysis of data from a randomized trial [ | PMC9859567 | |
5. Conclusions | This study identified predictors of re-engagement among adults enrolled in a cessation intervention who relapsed or failed to initially quit by three months after enrolling in a cessation quit line intervention study. We identified initial intervention use and personal characteristics associated with re-engagement, including non-White race and confidence in one’s ability to quit smoking someday. Our results point to the importance of initial quit line intervention engagement in the process of increasing the likelihood of re-engagement, specifically for participants who attended all offered counseling sessions. Future studies should further explore the associations between initial intervention engagement and potentially modifiable motivational factors that could be leveraged in future interventions to maintain continued engagement in the cessation process. | PMC9859567 | ||
Author Contributions | Conceptualization, K.P.W., R.C.K. and G.W.T.; methodology, K.P.W., X.-Q.W. and I.M.; formal analysis, X.-Q.W. and I.M.; writing—original draft preparation, K.P.W., C.A.A. and I.M.; writing—review and editing, X.-Q.W., D.G.C., M.A.P., M.A.L., G.W.T. and R.C.K.; funding acquisition, R.C.K., G.W.T. and M.A.L. All authors have read and agreed to the published version of the manuscript. | PMC9859567 | ||
Institutional Review Board Statement | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. | PMC9859567 | ||
Informed Consent Statement | The voluntary, fully informed consent of the subjects used in this research was obtained as required by 32 CFR 219 and DODI 3216.02_AFI 40-402. | PMC9859567 | ||
Data Availability Statement | This study was pre-registered at clinicaltrials.gov: NCT02201810. The analysis plan was not formally pre-registered. De-identified data from this study are not available in a public archive. De-identified data from this study will be made available (as allowable according to institutional IRB standards) by emailing the corresponding author. Analytic code used to conduct the analyses presented in this study are not available in a public archive. They may be available by emailing the corresponding author. Materials used to conduct this study are not publicly available. | PMC9859567 | ||
Conflicts of Interest | The authors declare that they have no conflict of interest. | PMC9859567 | ||
References | Demographic, tobacco use, and initial intervention use overall and by three-month re-engagement.Note: Baseline confidence in quitting and reasons for quitting by three-month re-engagement.Note: Association between personal characteristics, and initial intervention engagement with re-engagement at three months.OR: odds ratio; CI: confidence interval. Due to small sample sizes across each race, we were unable to differentiate between non-White categories. Therefore, the “Other races“ category includes Black, Asian, American Indian/Alaskan native, Pacific Islander, Multiple races, and those who reported other or preferred not to disclose. | PMC9859567 | ||
Supplementary Information | thrombotic thrombocytopenia purpura, organ damage | ITTP, SECONDARY, RECURRENCE | Caplacizumab is an anti-von Willebrand factor humanized single-variable-domain immunoglobulin fragment whose efficacy and safety in immune-mediated thrombotic thrombocytopenia purpura (iTTP) have been demonstrated in international studies. This prospective, open-label phase 2/3 study evaluated caplacizumab 10 mg administered daily during plasma exchange and for 30 days afterward, in combination with immunosuppressive treatment, in Japanese adults with a clinical diagnosis of iTTP (new or recurrent). The primary endpoint was prevention of iTTP recurrence; key secondary endpoints included time to platelet count response, time to organ damage normalization, and safety. Among 21 treated patients, 1 of 15 (6.7%) evaluable patients developed iTTP recurrence. Median time to normalization was 2.79 days for platelet count and 2.65 days for organ damage markers (The online version contains supplementary material available at 10.1007/s12185-022-03495-6. | PMC9970947 |
Keywords | PMC9970947 | |||
Introduction | ischemia, hemolytic anemia, TTP, Thrombotic thrombocytopenia purpura | HEMOLYTIC ANEMIA, THROMBOCYTOPENIA, ISCHEMIA, ITTP, TTP | Thrombotic thrombocytopenia purpura (TTP) is an acute life-threatening condition characterized by thrombocytopenia, non-immune hemolytic anemia and organ ischemia [The acquired, or immune-mediated, form of TTP (iTTP) is rare, but more prevalent than the hereditary form [Approximately 18% of individuals with iTTP are refractory to the standard treatments [Caplacizumab is a humanized, single-chain dimer, bivalent, variable-domain-only immunoglobulin fragment directed against the A1 domain of VWF, which inhibits the interaction between VWF and glycoprotein Ib-IX-V receptors on platelets [Thus, the aim of the current phase 2/3 study was to evaluate the efficacy and safety of caplacizumab, in addition to standard care, in Japanese individuals with iTTP. | PMC9970947 |
Materials and methods | PMC9970947 | |||
Study design | ITTP, MAY, RECURRENCE | This was a prospective, single-arm, open-label study (NCT04074187) conducted at 11 centers in Japan between October 2019 and May 2021, and sponsored/funded by Sanofi. The primary objective of the study was to evaluate the ability of caplacizumab to prevent the recurrence of iTTP during the overall study period.The protocol and other relevant documents were approved by an Institutional Review Board prior to study initiation. In addition, the study was conducted in accordance with the protocol and ethical principles outlined in international guidelines including the Declaration of Helsinki, and the International Conference on Harmonization Good Clinical Practice Guidelines, as well as any applicable laws, rules, and regulations. Participants, or their legally authorized representative, provided written informed consent prior to any study procedures being undertaken. | PMC9970947 | |
Participants | thrombocytopenia, ADAMTS13, TTP | ITTP, THROMBOCYTOPENIA, TTP | The study included male or female Japanese individuals aged ≥ 18 years with a clinical diagnosis of iTTP (initial or recurrent) that required initiation of daily TPE treatment. A confirmed diagnosis of iTTP based on ADAMTS13 activity was not required for study enrollment. The TTP clinical diagnosis was defined as thrombocytopenia (platelet count < 100 × 10 | PMC9970947 |
Treatment | autoimmune disease | AUTOIMMUNE DISEASE | Eligible participants received caplacizumab 10 mg once daily, in addition to standard care, throughout the TPE treatment period and for 30 days after completion of TPE. The first caplacizumab dose was administered by intravenous injection at least 15 min prior to TPE, with subsequent doses administered subcutaneously after TPE. After Day 2, caplacizumab was administered subcutaneously after TPE. Standard care was administered according to Japanese guidelines [The minimum study period was the duration of daily TPE treatment plus 30 days of post-TPE treatment, and 30 days of follow-up period, but this could be extended if participants did not have resolution of the underlying autoimmune disease (Fig. Study design. | PMC9970947 |
Endpoints | thrombocytopenia, death | THROMBOEMBOLIC EVENT, RECURRENCE, RECURRENCE, THROMBOCYTOPENIA, ITTP | The primary endpoint of the study was the proportion of participants with a recurrence of iTTP during the overall study period and was assessed in the per-protocol (PP) population. Recurrence was defined as recurrent thrombocytopenia after initial recovery of platelet count (confirmed platelet count ≥ 150 × 10Secondary endpoints, assessed in the PP and modified intention-to-treat (mITT) populations, included the composite endpoint of iTTP-related death, iTTP recurrence, or ≥ 1 treatment-emergent major thromboembolic event; the proportion of participants with refractory iTTP (persistent thrombocytopenia, lack of a sustained platelet count increment or platelet count < 50 × 10 | PMC9970947 |
Outcome assessments | bleeding, organ damage, ADAMTS13 | EVENTS, BLEEDING | The use of TPE and other medications, as well as bleeding events, platelet count, and organ damage markers, were recorded daily until the end of TPE, weekly until the end of the study, and at the first and last follow-up visits. In addition, the Standardized Mini-Mental State Examination (SMMSE) [With regards to caplacizumab pharmacokinetics, total caplacizumab plasma concentrations were evaluated on Days 2 and 3, then weekly thereafter. Pharmacodynamic parameters (i.e., VWF:Ag, FVIII:C, and VWF:RCo) were evaluated on Days 1, 2, and 3 of the daily TPE period, and then daily during the rest of the follow-up up period. ADAMTS13 activity was evaluated on Day 1 of the daily TPE period, then weekly until the end of the study, and at the first and last follow-up visits. A description of other assessments is provided in the Supplementary Methods. | PMC9970947 |
Statistical analysis | SE | ITTP, DISEASE, RECURRENCE | The planned sample size was 15 participants, based on feasibility considerations; no sample size calculation was performed. The success criterion for the study was ≤ 20% of evaluable participants (i.e., PP population) with a recurrence of iTTP during the overall study period. The PP population (the primary analysis population) included all participants in the mITT who completed treatment and follow-up, or had an iTTP recurrence, and no major protocol deviations. Any individual who was found to have a disease other than iTTP after enrollment was excluded from the PP population. The mITT and safety populations were both defined as all participants who received at least one dose of caplacizumab.In general, all endpoints were summarized descriptively using total numbers, means, standard errors (SE), medians, confidence intervals (CIs), and ranges (minimum–maximum) for continuous variables, and frequencies and percentages for categorical variables. Time-to-event data were summarized using Kaplan–Meier estimates. | PMC9970947 |
Results | PMC9970947 | |||
Efficacy | PMC9970947 | |||
Organ function parameters and cognitive function | SE, organ damage, cognitive impairment | In the PP population, 14 of 15 (93.3%) participants experienced normalization of all three organ damage maker levels, with the median time to normalization in these individuals occurring at 2.65 (95% CI: 0.98–4.98) days (Fig. Kaplan–Meier plot of time to normalization of all three markers of organ damage (lactate dehydrogenase, cardiac troponin I, and serum creatinine) in the per-protocol population. The x indicates a censored eventMean (range) SMMSE scores improved steadily over the course of treatment in the PP population, from 17.7 (0–30) at baseline (i.e., moderate cognitive impairment) to 25.5 (0–30) on day 5, 27.9 (16–30) at Week 1 (i.e., mild cognitive impairment), 29.6 (27–30) at Week 5 (i.e., normal cognition), and 29.9 (29–30) at the final follow-up visit. Mean (SE) SMMSE scores are shown in Fig. Mean (standard error) standardized Mini-Mental State Examination scores in the per-protocol population. | PMC9970947 | |
TTP treatment course | The fresh-frozen plasma (absolute plasma volume) replaced in the PP population by TPE over 3–11 days (median 5 days) ranged between 13.4 and 50.0 L (median 24.6 L) in the overall treatment period. Median normalized plasma volume, which is TPE days multiplied by the ratio of absolute plasma volume by estimated plasma volume, was 7.5. Seven participants in the PP population had an intensive care unit (ICU) admission during the study period; durations of ICU admission ranged from 2 to 8 (median 5) days in the overall study period. All 15 participants in the PP population were admitted to hospital; the duration of hospitalization was 10–56 days (median 37) in the overall study period. | PMC9970947 | ||
Pharmacokinetics and pharmacodynamics | Plasma caplacizumab concentrations remained consistent throughout the treatment period (Supplementary Fig. S1). During the post-daily TPE period, mean plasma concentrations ranged from 611 ng/mL to 785 ng/mL.Mean levels of VWF:Ag (Supplementary Fig. S2) and FVIII:C (Supplementary Fig. S3) and VWF:RCo (Fig. Mean plasma levels of von Willebrand factor ristocetin cofactor (VWF:RCo) in the safety population. Error bars represent standard error of the mean; D2–3 is the daily TPE period, W1–W10 is the post-daily TPE period; VWF:RCo values of < 20% represent the threshold for pharmacologic activity of caplacizumab. The mean VWF:RCo of 29.2% at Week 4 (slightly above the 20% threshold) was caused by an aberrant data point of 279.6% from one participant who stopped caplacizumab due to physician decision, | PMC9970947 | ||
ADAMTS13 activity | ADAMTS13 | ITTP, EVENT, RECURRENCE | Mean ± SE ADAMTS13 activity increased steadily from 7.06 ± 6.12% at screening to 39.37 ± 7.80% at the end of Week 1, then dropped to 28.18 ± 6.76% at Week 2 (1 week after the end of TPE), and increased again to 49.5 ± 10.15% by the Week 5 visit. The participant who had iTTP recurrence had an ADAMTS13 activity level of < 1% at the time of the recurrence. ADAMTS13 activity level at the end of treatment exceeded 10% in all participants. Twenty of 21 participants achieved a sustained ADAMTS13 level of ≥ 10%, which was defined as two consecutive weekly visits at which ADAMTS13 activity was ≥ 10%, and the median time to achievement was 13.68 (95% CI 5.95–24.76) days (25% quartile 5.95 [95% CI 4.44–6.92] days; 75% quartile 33.53 [95% CI 13.69–46.90] days; Fig. Kaplan–Meier curve of recovery of A disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13) activity level to ≥ 10%. The x indicates a censored event | PMC9970947 |
Immunogenicity | Three participants (14.3%) developed anti-caplacizumab antibodies during treatment. Neither pre-existing antibodies nor anti-drug antibodies were found to have an influence on the time to platelet count response, plasma caplacizumab concentrations, VWF:RCo, or VWF:Ag levels. | PMC9970947 | ||
Discussion | ADAMTS13, exacerbations, cognitive impairment, initiation of caplacizumab., TTP | RECURRENCE, DISEASE, ITTP, SECONDARY, TTP | This study, the first to evaluate caplacizumab treatment in Japanese individuals with iTTP, indicates that adding caplacizumab to the standard protocol of TPE and immunosuppressive treatment results in a low rate of iTTP recurrence, and rapid normalization of platelet count and organ function parameters. It is notable that the participants in our study were generally older than those seen in US and European studies of individuals with iTTP (median 59 years versus 33–41 years) and included a lower proportion of females (48% vs. 77–82%) [Only one participant in the current study had an iTTP recurrence after caplacizumab had been interrupted, so the primary endpoint occurred at a rate of 6.7%, well below the 20% rate used as a predefined criterion of success. This criterion corresponds to the number of participants fewer than three out of 15 patients (below 20%), which is set based on the expected number of participants with recurrence in our study would be 2.25 (the expected recurrence rate of 15%), assuming that capalacizumab treatment reduces relative risk (an estimated recurrence rate without capalacizumab treatment of 30%, which is based on a systematic review of past studies [The favorable efficacy of caplacizumab treatment was also observed with regard to the secondary endpoints in our study. All 15 participants (100%) in the PP population and 17/21 participants (81.0%) in the mITT population experienced a rapid platelet count response, and the median times to platelet count normalization in our study (median 2.79 days in the PP population and 3.49 days in the mITT population), were similar to those observed in the TITAN and HERCULES studies [Fourteen of 15 participants (93.3%) in the PP population and 18 of 21 participants (85.7%) in the mITT population had normalization of all three organ damage marker levels within a median of 2.65 days and 3.57 days, respectively. The normalization of organ damage marker levels was almost as rapid as the platelet response, suggesting that suppression of microthrombus formation during caplacizumab treatment leads to a rapid recovery from iTTP-related organ damage. In addition, rapid improvement from baseline in SMMSE scores indicated that cognitive impairment due to iTTP, present prior to the start of caplacizumab treatment, rapidly reversed after initiation of caplacizumab.In line with data from the HERCULES and TITAN studies, none of the individuals who received caplacizumab in our study developed refractory disease. In the HERCULES study, none of the 65 caplacizumab recipients had refractory disease, but 3 of the 64 placebo recipients (4.7%) had refractory acquired TTP [The type and incidence of caplacizumab-related TEAEs in the current study were similar to those reported in the TITAN and HERCULES studies [VWF is the target molecule of caplacizumab and is also known to contribute to stabilization of FVIII. In this study, pharmacodynamic parameters, including VWF:RCo, VWF:Ag, and FVIII:C, showed a similar trend to that observed in the TITAN study [Our data support previous findings that ADAMTS13 activity is a predictor of exacerbation or recurrence. In our study, the only participant who had an iTTP recurrence had an ADAMTS13 level of < 1%. Similarly, almost all exacerbations and relapses in caplacizumab recipients in the TITAN and HERCULES studies occurred in participants with an ADMATS13 activity of < 10% at the end of treatment [Our study has some limitations, specifically the small sample size arising from the rarity of iTTP in clinical practice, and the lack of a control group. Given these limitations, results should be considered preliminary; however, it is important to note that they are internally consistent across endpoints, as well as being externally consistent with previously published data in mostly European individuals with TTP.In conclusion, in Japanese individuals with iTTP, caplacizumab in combination with TPE and immunosuppressive treatment was associated with a low rate of iTTP recurrence (6.7%), which met the criterion for success, and rapid normalization of platelet counts and organ damage markers. No unexpected TEAEs were identified in the Japanese study population. | PMC9970947 |
Acknowledgements | The authors thank Catherine Rees of inScience Communications, Springer Healthcare, who wrote the outline of the manuscript and Andrea Bothwell who wrote the first draft on behalf of inScience Communications, Springer Healthcare. This medical writing assistance was funded by Sanofi K.K., Japan. | PMC9970947 | ||
Author contributions | MM | MM and YM contributed to conception and design of the work. YM, KI, SI, HU, YU, AY, SF, TM, HA, KN, KS, YO, and HM contributed to data acquisition. MM, YM, YH, TT, and ST contributed to data analysis or interpretation of data. All authors have agreed to take responsibility for the aspects of the work with which they were involved. All authors critically reviewed, edited and revised the drafts of the manuscript, approved the final draft for publication, and agreed to its submission to IJH. | PMC9970947 | |
Data availability | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of our trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at: | PMC9970947 | ||
Declarations | PMC9970947 | |||
Conflict of interest | MM | BLOOD | YM served as a consultant for Sanofi K.K. and Zenyakukogyo Co., Ltd., has participated in advisory boards for Sanofi K.K., and received research funding from Sanofi K.K. KI received honoraria from Celgene Co., Ltd., Bristol-Myers Squibb K.K., Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Otuka Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., Novartis Pharma K.K, Meiji Seika Pharma Co. Ltd., Ono Pharmaceutical Co. Ltd., Janssen Pharmaceutical K.K., Nippon Shinyaku Co., Ltd., and AstraZeneca K.K. SI received honoraria from Sanofi K.K., AstraZeneca K.K, and Chugai Pharmaceutical Co., Ltd. TM served on advisory boards for Takeda Pharmaceutical Co. Ltd. (Baxalta/Shire), Bayer Yakuhin, Ltd., Novo Nordisk Pharma Ltd., Chugai Pharmaceutical Co., Ltd., and Pfizer Inc., received educational and investigational support from Chugai Pharmaceutical Co., Ltd. and Novo Nordisk Pharma Ltd., and received honoraria from Takeda Pharmaceutical Co. Ltd. (Shire), Bayer Yakuhin, Ltd., Sanofi K.K. (Bioverative), Chugai Pharmaceutical Co., Ltd., CSL Behring K.K., Japan Blood Products Organization, KM Biologics Co., Ltd., Kyowa Kirin Co., Ltd., Nichiyaku, Novo Nordisk Pharma Ltd., Octapharma AG, and Sysmex Corporation. MM received honoraria from Asahi Kasei Pharma Corporation, Chugai Pharmaceutical Co., Ltd., and Alexion Pharma Inc., has served as a consultant for Sanofi K.K., Takeda Pharmaceutical Co. Ltd., and Alexion Pharma Inc., received research funding from Asahi Kasei Pharma Corporation and Chugai Pharmaceutical Co., Ltd., and received patents and royalties from Alfesa Pharma Corporation. YH, ST, HM, and TT are currently employed by Sanofi K.K. HU, YU, AY, SF, YO, HA, KN, and KS declare that they have no conflicts of interest. | PMC9970947 |
References | PMC9970947 | |||
Methods | Forty-six young men were recruited (mean age: 20.65 years) and assigned randomly to aerobic exercise (n = 15), cognitive training (n = 15), or dual-task (n = 16) groups. Executive functions were assessed before, immediately after, and 30 min after intervention using Go/No-go, 2-back, and More-Odd-Shifting tests. | PMC10431647 | ||
Results | Working memory function improved after all three interventions (significant Time effect, | PMC10431647 | ||
Conclusion | Executive function was enhanced by single-task (acute aerobic exercise or cognitive training) and dual-task interventions. The effect continued for 30 min after both the single-task aerobic exercise and the dual-task intervention. For short-term intervention, the dual-task was not more effective than either of the single tasks. | PMC10431647 | ||
Data Availability | The data that support the findings of this study are available from figshare, DOI: | PMC10431647 | ||
1. Introduction | In daily life, people must often perform motor and cognitive tasks at same time, such as shopping, counting coins while queuing up, or walking while answering a mobile phone call. Poor dual-task performance can greatly impact activities of daily life [EF continues to change throughout life [Aerobic exercise is a good non-pharmacological means of improving EF [Motor-cognitive dual-tasks might be more effective than single-domain tasks as a way to improve executive function because dual tasks have been reported to use greater cognitive resources than the same tasks done separately (aerobic exercise or cognitive training alone) [ | PMC10431647 | ||
2. Methods | PMC10431647 | |||
2.1 Participants | cognitive impairments, musculoskeletal difficulties | COLOR BLINDNESS, CARDIOPULMONARY DISEASE, MOVEMENT DISORDERS | We estimated simple size (n) using a power analysis with the following parameters in G*power. We set effect size = 0.25; alpha err prob = 0.05; power (1—beta err prob) = 0.80; number of groups = 3; number of measurements = 3; corr among rep measures = 0.5; and nonsphericity correction ε = 0.5. The resulting sample size (n) was 45. This work was conducted using a small sample size because recruiting participants was difficult during the COVIN-19 period.Participants were generally healthy young men who were recruited through social media and telephone advertisements. Inclusion criteria were as follows: (1) Community-dwelling young men aged 18–30 years; (2) no cognitive impairments; (3) Montreal Cognitive Assessment (MoCA) score ≥ 24; (4) ability to read Chinese characters; (5) normal or corrected-to-normal vision; (6) had enough sleep the day before the experiment; (7) middle to high physical activity levels as determined by the International Physical Activity Questionnaire (IPAQ); (8) received a good education (high school degree and above), could understand simple English words. Exclusion criteria were as follows: (1) color blindness or deficiency in color vision; (2) any severe cardiopulmonary disease; (3) any musculoskeletal difficulties that prevent exercise or other movement disorders; (4) taking of any medication during the intervention period that could impair cognitive function; and (5) alcohol consumption within 24 hours before the experiment. Individuals who met the inclusion criteria provided their informed written consent to participate in this study. | PMC10431647 |
2.2 Interventions | Participants were assigned to one of three groups: aerobic exercise, cognitive training, or dual-task (both aerobic exercise and cognitive training). Interventions lasted 30 min and were conducted in a quiet room. | PMC10431647 | ||
The intervention procedures. | PMC10431647 | |||
2.2.1 Aerobic exercise intervention | Based on the American College of Sports Medicine’s standard for grading the intensity of aerobic exercise for healthy adults, combined with the research results from other scholars, participant heart rate while exercising should range between 60% to 70% of the maximum heart rate [ | PMC10431647 | ||
2.2.2 Cognitive intervention | Based on earlier studies [The calculation task was designed to help improve global EF. A simple 2-number addition or subtraction problem comprising 2-digit numbers was presented on the computer screen for 5 s (e.g., 28 + 14, 39–15), and participants had to provide their answer before the problem disappeared. There were 60 trials in total, and the task lasted 5 min.The naming task was designed to help develop the ability to shift attention. Participants were asked to speak the names of ordinary items that were displayed at the center of a computer screen for 5 s (e.g., apple, sofa) before the images disappeared. The task comprised 60 trials, each with a different photograph. The task lasted 5 min.The Stroop color-word task is known to help improve inhibitory control [The working memory task was used to improve updating ability. A series of numbers (e.g.,14562, 79451) was presented on the computer screen for 2 s, and then faded to the same color as the background for 3 seconds. The participants repeated the series of numbers in threes, and the tester judged whether the answer was correct. The task lasted 5 min. | PMC10431647 | ||
2.2.3 Dual-task intervention | Dual-task intervention combined aerobic exercise and cognitive intervention. The participants were required to pedal the cycle ergometer at a moderate intensity while doing the cognitive tasks. | PMC10431647 | ||
2.3 EF measurements | All EF measures were collected in a light and sound-attenuated room with participants seated in a comfortable chair. Before the intervention, global cognitive state was assessed using the MoCA. Three tests were used to measure the three aspects of EF before intervention, immediately after intervention, and 30 min after intervention. | PMC10431647 | ||
2.3.1 Inhibition control | A Go/No-go task was used to measure inhibition control [ | PMC10431647 | ||
2.3.2 Information updating | The ability to update information was evaluated using a 2-back task [ | PMC10431647 | ||
2.4 Rule shifting | The more-odd-shifting task was used to measure shifting ability [ | PMC10431647 | ||
2.5 Statistical analysis | For normally distributed data, continuous variables are reported as mean ± standard deviation. Tests of normality followed by analysis of variance (ANOVA) were used to examine all data. The effects of Time (before, immediately after, 30 min after) and Group (exercise, cognitive training, dual-task) on EF were assessed using as 2-factor ANOVA. Greenhouse-Geisser adjustment was employed when the data did not pass Mauchly’s sphericity test. Statistical significance was set to | PMC10431647 | ||
3. Results | PMC10431647 | |||
3.1 Participant characteristics | Fifty-one young men were recruited, and 46 ultimately agreed to participate in the study. They were assigned to the aerobic exercise (n = 15), cognitive training (n = 15), and dual-task (n = 16) groups. | PMC10431647 | ||
Baseline characteristics. | *p<0.05, **p≤0.01; MoCA: Montreal cognitive assessment. | PMC10431647 | ||
Results of executive function measurement across intervention groups at three time points. | Abbreviations: Values are presented as mean ± SD.Inhibition control was assessed using a Go/No-go task. The two-way ANOVA for performance on the Go/No-go task revealed a main effect of Time (The two-way ANOVA for Go/No-go response time did not find any differences among the three groups at any of the three time points ( | PMC10431647 | ||
3.3 Information updating | The 2-back task was used assess the ability to update working memory. On task accuracy we found a significant main effect of Time ( | PMC10431647 | ||
3.4 Rule shifting | The ability to shift between rules was assessed using the more-odd-shifting task. We found a significant main effect of Time ( | PMC10431647 | ||
4. Discussion | We examined the effects of aerobic exercise, cognitive training, and dual-task intervention on EF in young men. We found that 30-min of intervention improved some aspects of EF, regardless of the type of intervention. Specifically, both 30-min of single-task aerobic exercise intervention and 30-min of dual-task intervention improved attention shifting and working memory updating abilities. We did not find any significance different in inhibitory control. Most importantly, we did not find that dual-task interventions improved EF any more than single-task, aerobic or cognitive, interventions. | PMC10431647 | ||
The effect of acute aerobic training on EF | CORTEX | Our results showed a main effect of Time on accuracy for the shifting task. This is consistent with previous research showing that only 30 min of acute moderate-intensity aerobic exercise improved shifting ability in all age groups [In our study, we only assessed EF with cognitive tests. However, other studies have used neuroimaging techniques to examine the effects of acute aerobic exercise on brain activity. Functional magnetic resonance imaging (fMRI) and functional near-infrared spectroscopy (fNIRS) evidence has suggested that the prefrontal cortex, which is important for executive function, may be especially sensitive to exercise-induced neurophysiological changes, and that increases in central arousal [Thus, we believe that acute aerobic exercise can improve EF in young men, but it is worth noting that changes in BDNF following acute aerobic exercise are transient [ | PMC10431647 | |
The effect of acute cognitive training on EF | CORTEX | Although we did not find significant differences in EF after a bout of cognitive training, we observed a trend for information updating and shifting to be improved. Cognitive training improves EF by activating the prefrontal cortex, which is important for EF [ | PMC10431647 | |
The effect of acute dual-task intervention on EF | The dual-task intervention led to improved EF in terms of shifting and working memory abilities, and the effect lasted for up to 30 minutes after the intervention. Similarly, Pellegrini-Laplagne et al. [However, as with acute aerobic exercise, we did not find any changes in inhibition control. Indeed, results regarding inhibition control are mixed in the literature. While one study found it beneficial [According to a recent study, EF deeply regulates motor-cognitive dual-tasks [Although our result did not show the difference effect of EF between the single aerobic exercise and the motor-cognitive dual task, there were some variation according to neuroimaging evidence (fMRI, fNIRS), like dual-task elicited larger region of activity in the frontal and parietal lobes than did single-tasks [On the other hand, compared with short-term intervention, long-term intervention made difference between single task and dual-task. 12-week dual-task training improved more cognitive ability domains in older people than did single-task training [ | PMC10431647 | ||
Limitation | motor-cognitive dual-task training on EF | Limitations of the current study include its small sample size, which reduces the power to detect significant effects. Second, we only measured behavior. It will be important in future studies to investigate the dynamic changes in brain activity following motor-cognitive dual-task training. Although, short-term intervention is an effective way to explore the effect of dual-tasks on the EF of an individual, long-term intervention might be a better way to achieve continuous benefits. It is essential to conduct a large trial to examine the effect of motor-cognitive dual-task training on EF in a wide range of people. | PMC10431647 | |
5. Conclusion | The major conclusion that can be drawn from this study is that acute aerobic exercise, cognitive training, and dual-task intervention for 30 min can improve the EF performance for young men. Acute aerobic exercise and the dual-task promoted working memory and shifting ability. Moreover, the improvement after dual-task intervention lasted for at least 30 min.The author is grateful to all participants. | PMC10431647 | ||
Background | lumbar medial branch block, pain, disability, LMBB, LFJ, facet joints | The aim of this multicenter randomized interventional prospective study was to compare the ultrasound (US)-guided lumbar medial branch block (LMBB) with the fluoroscopy (FS)-guided LMBB in terms of analgesic efficacy and disability in the setting of the treatment of pain arising from the lumbar facet joints (LFJ). | PMC10007783 | |
Methods | Anxiety, Pain, Oswestry Disability, Depression, LFJ” syndrome | Fifty adults with a “LFJ” syndrome were randomized into two groups: in group FS, fluoroscopic-guidance was used to block the medial branch at three lumbar levels (L3-L4, L4-L5 and L5-S1); in group US, same blocks were performed under ultrasound. Needle transverse approach was used with both techniques. Effects of these procedures were assessed with a Visual Analogue Pain Scale (VAPS), the Oswestry Disability Index (ODI) and the Duke’s Activity Status Index (DASI) scale, before the treatment, 1 week and 1 month after. Hospital Anxiety and Depression Scale (HADS) score was also collected before the procedure. Analysis of variance, one (for non-inferiority) and two-sided Mann-Whitney tests and Chi-square tests were performed. | PMC10007783 | |
Results | LMBB | LMBB under US-guidance was not inferior to FS-guidance ( | PMC10007783 | |
Conclusions | pain, bundle branch block | BUNDLE BRANCH BLOCK | The medial lumbar bundle branch block under ultrasound-guidance is not inferior to the fluoroscopy-guidance procedure in effectively alleviating pain arising from the facet joints. Considering that this ultrasound technique has the benefit of an irradiation-free, real-time procedure, it can be considered as an effective alternative to the fluoroscopy-guided technique. | PMC10007783 |
Keywords | PMC10007783 | |||
Introduction | lumbar medial branch block, Lumbar facet joints, pain, LMBB, LFJ, LBP | ARTHRITIC CHANGES, CHRONIC LOW BACK PAIN, DEGENERATIVE, INFLAMMATION, SYNDROME | Lumbar facet joints (LFJ) syndrome is a common source of spinal suffering affecting up to 45% of patients with a chronic low back pain (LBP) because of inflammation, degenerative or arthritic changes, overload of the posterior LFJ or muscle imbalance [In fact, it cannot be identified by imaging or physical examination alone, because of various presentations (often pain exacerbated by lumbar extension, lateral flexion or rotation) and referred pain, making the diagnosis complicated [The first-line therapy for the alleviation of chronic LBP of zygapophyseal joint origin includes bedrest, oral analgesics/anti-inflammatory drugs and physical therapy. If unsuccessful, intra-articular injections and lumbar medial branch block (LMBB) can provide diagnosis and are always performed prior to the neurotomy (radiofrequency or cryoneurolysis) which is able to provide short and long-term pain relief [According to pain centers, LMBB is realized by fluoroscopy (FS), ultrasonography or computed tomography (CT) scanner for guidance [The aim of the present study was to prospectively compare the effectiveness of those two imaging-guided techniques regarding the early and long term pain scores. | PMC10007783 |
Materials and methods | PMC10007783 | |||
Design and population | tumor, Pain, anxiety, stroke, allergy, psychiatric, neurological diseases, Depression, Anxiety, fracture, radiculitis, depressive disorders, Oswestry Disability, infection, LMBB, hematoma, LBP, scoliosis, pain, Parkinson’s disease, LFJ | TUMOR, INFILTRATION, NEUROLOGICAL DISEASE, ANKYLOSING SPONDYLITIS, SCOLIOSIS, ADVERSE EVENTS, STROKE, ALLERGY, DISORDERS, RADICULITIS, SPINAL INSTABILITY, INFECTION, SYSTEMIC INFECTION, SYNDROME, COAGULATION DISORDER, HEMATOMA, VASOVAGAL SYNCOPE | This prospective multicenter randomized controlled trial was conducted from 6 January 2021 until 10 March 2022 in three pain management centers in Brussels (Belgium); Saint-Pierre University Hospital (César de Paepe site), Erasme and Braine-l’Alleud Hospitals. This open label study was approved by the three Ethics Committees of ULB (main center is Erasme Hospital; P2020/557, 31th of December 2020 - B4062020000221) and was registered on the publicly accessible Clinical Trial Registry (NCT04658953, 09/12/2020).All participants received and signed an informed consent before the infiltration including all the information about the procedure, the benefits and the possible risks (hematoma, infection, vasovagal syncope, intrathecal injection and spinal anesthesia). Allocation concealment was achieved using opaque numbered sealed envelopes, opened only after each patient’s arrival in the operating theatre, in each center. Patients beneficiated the FS or the US technique, according to the randomization and both the attending anesthetist and the patient were aware of the allocated technique. All patients enrolled in the study were requested to report to investigators the evolution of the applied scores variables by phone at the predetermined time points.Inclusion criteria: patients aged between 20 and 80 years old, having a chronic LBP compatible with a LFJ syndrome for at least 3 months without response to a conservative treatment of minimum 4 weeks.Exclusion criteria: refusal to participate to the study, pregnant or breastfeeding women, allergy to injected products (Methylprednisolone (Depomedrol) or Lidocaine (Linisol)), psychiatric disorders hindering understanding of the protocol, local or systemic infection or coagulation disorder. In addition, patients should not present any sign of dissociated pain, radiculitis, neurological diseases (including stroke, Parkinson’s disease), spinal instability or deformities (such as scoliosis, ankylosing spondylitis), history of lumbar surgery, fracture or lumbar tumor. Further, patients with a body mass index (BMI) > 35 kg/mFor this study, the investigators have blocked the LMBB on three lumbar levels (L3-L4, L4-L5 and L5-S1) performed under US versus FS according to a transverse approach. The aim was to compare the equivalence of these two modalities by the evaluation of the benefit of the procedures on pain with a Visual Analogue Pain Scale (VAPS), the evolution of the possibility of carrying out daily activities with the Duke’s Activity Status Index (DASI) and the limits of daily activities with the Oswestry Disability Index (ODI). Scores were collected before injection, 1 week and 1 month after. Hospital Anxiety and Depression Scale (HADS) before the procedure was also filled to detect anxiety and depressive disorders in the setting of the treatment of pain arising from the lumbar facet joints. Moreover, duration of the procedures, incidence of adverse events, work status and medications were obtained | PMC10007783 |
US-guided and FS-guided infiltrations | TUNNEL VISION, LORDOSIS, INFILTRATION | Patients were positioned in prone position with a pillow under the stomach to facilitate the view of the structures by compensating the lumbar lordosis. After disinfection of the lumbo-sacral region with alcoholic chlorhexidine 0,5%, an infiltration was performed in three puncture points unilaterally (L3-L4, L4-L5 and L5-S1 levels) with a 22-gauge spinal needle in the transverse plane. At each level, 1 mL of a mixture consisting of 3 mL of Linisol 2% (60 mg of lidocaine) plus 1 mL of Depomedrol 40 mg/Lidocaine 10 mg was injected. The procedure time was recorded from insertion to removal of the needle. The ultrasound devices used were different between the centers; C6–2 probe of the Sparq ultrasound system (Philips N.V., Netherlands) at César de Paepe Hospital, C1–5 probe of the Logiq S8 ultrasound system (GE Healthcare Inc., Illinois, United States) at Erasme and Braine-l’Alleud Hospital. The scopies used were also different; Ziehm brand (Ziehm Inc., Florida, United States) at César de Paepe and Siemens brand (Siemens Healthcare Gmbh, Germany) at Erasme and Braine-l’Alleud Hospitals. It should be noted that thermocoagulation was performed after 2 weeks on patients at the Braine-l’Alleud hospital.In the US group, once the spinous processes of the lower lumbar vertebrae were located, with a convex probe with the mark on the cranial side (Fig. Firstly, the probe was placed longitudinally in order to have the facet paramedian sagittal view (wave image). Secondly, a rotation of 90° was made to be in the transverse planeIn the FS group, The C-shaped arm of a X-ray fluoroscopy was positioned around the patient in an antero-posterior view tilted ¾ in order to see the classic view called “scotty dog”. The puncture point was determined by the positioning of the needle with the so-called “tunnel vision”. The needle was thus brought to the bone contact corresponding to the eye of the scotty dog in tunnel vision, corresponding to the area of passage of the lumbar median branch. | PMC10007783 | |
Statistical analysis | LMBB | The primary endpoint was to investigate the non-inferiority of the US group, comparing to the FS group in regard to the evolution of the ODI measured 1 month after the LMBB. Power analysis was performed with a projected standard deviation of 7. If there was truly no difference between the standard and experimental treatment, then 50 patients are required to be 80% sure that the lower limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will be under the non-inferiority limit of + 5 points. Analysis of non-inferiority was realized with a one-sided Mann-Whitney test.All data for the ODI, the VAPS and the DASI measured before, 1 week and 1month after the LMBB were compared by an analysis of variance for repeated measures with mixed models with treatment arms, time, thermocoagulation status, time x treatment interaction, thermocoagulation status x time interaction and time x treatment x thermocoagulation status interaction terms.Categorical data were compared by a χ | PMC10007783 | |
Discussion | Facet syndrome, Facet joints, anxiety, facet joints, LFJ syndrome, fibromyalgia, chronic pain, fibrous, pain, zygapophyseal joints, LMBB, depression, LFJ, LBP | RHEUMATOID ARTHRITIS, MUSCLE WEAKNESS, INFILTRATION, FIBROMYALGIA, LOCAL ANESTHETICS, CHRONIC PAIN, COMPLICATIONS | This prospective randomized study showed that the LMBB under US-guidance is not inferior to FS-guidance. It confirmed the retrospective results of Han et al. [Few patients are no longer taking medications and have psychological follow-up. The pain is not always treated optimally in the “bio-psycho-social” model required for chronic pain. Chronic LBP is often multifactorial and is a major health care problem. Accordingly, more attention should be paid to it in order to avoid depression, anxiety and work stoppage (76% of our patients no longer work), which has a major socio-economic impact and sometimes leads to a sedentary lifestyle causing muscle weakness, eliciting a vicious circle of risk of chronic pain [As a reminder, five vertebrae constituting the lumbar spine are separated anteriorly by the discs which can be a source of pain and posteriorly by the LFJ also called zygapophyseal joints, composed of the superior articular process and inferior articular process. Between these articular processes, lies the synovial membrane, a hyaline cartilage covered by the fibrous capsule within the lumbar spine (Fig. Facet joints of spine’s anatomy. Facet syndrome is a pain that can originate from any structure of the facet joints; fibrous capsule, synovial membrane, hyaline cartilage and boneLMBB is a diagnostic block but can sometimes be considered as therapeutic due to 3.5 months average pain relief of LBP and the significant improvement in functional capacity [Local anesthetics were injected since it blocks the sympathetic reflex arc and the axonal transport inside nerve fibers. Furthermore, it suppresses nociceptive discharge with anti-inflammatory effect. In addition, we use corticosteroids for their anti-inflammatory, immunosuppressive and anti-edematous effects with an inhibitory action of neuronal transmission in the C fibers [Even if US-guidance does not clearly detect a foraminal extent and an intravascular injection, these complications have also been described with the technique by FS-guidance [As limits to our study, we note a small population sample with an age variability implying anatomical distinctions, a relatively short follow-up of 1 month and the different ultrasound and fluoroscopy machines between the centers. More, patients often have other complaints than pain unilateral LFJ syndrome (such as bilateral pain, pain in knees, hips, rheumatoid arthritis, fibromyalgia etc): this lack of homogeneity is certainly unavoidable when considering the types of patients who visit pain clinics. Also, patients report changes in VAPS levels over the course of the day and according to their activities so all of that biases the rating scales. Although thermocoagulation is performed after 2 weeks at Braine-l’Alleud Hospital, it has no influence on the comparison between the two techniques.Despite the benefit of LMBB, there are few articles comparing imaging methods for this infiltration as well as on improving the quality of life of patients after the procedure, which is essential. For future investigations, we propose the comparison of LMBB performed by FS versus US with the US-guidance in a longitudinal axis (as proposed by Chang et al. but not yet validated) which requires only one puncture instead of three, which would be an advantage for patient (faster and less painful) [ | PMC10007783 |
Acknowledgements | We thank all participants for accepting the study and for taking the time to answer questions by phone. | PMC10007783 | ||
Significance | bundle branch block | OBESE, BUNDLE BRANCH BLOCK | Ultrasound-guided medial lumbar bundle branch block should be preferred to the fluoroscopy technique whenever it is possible in patients who are not morbidly obese. Indeed, fluoroscopy is considered as the gold standard but is irradiating and does not allow manipulations as precise as ultrasound. | PMC10007783 |
Authors’ contributions | Nisolle Marie-Laure | Dr. Nisolle Marie-Laure and Dr. Ghoundiwal Djamal designed the study protocol with the contribution of Prof. Tuna Turgay, Prof. Guntz Emmanuel and Prof. Kapessidou Panayota, Dr. Ghoundiwal Djamal, Dr. El Founas Walid and Dr. Gouwy Jonathan recruited the patients. Dr. Nisolle Marie-Laure phoned patients to collect answers to the questionnaires and wrote the manuscript. Prof. Engelman Edgard did the statistics. All authors reviewed the article and approved the final manuscript. | PMC10007783 | |
Funding | We did not need any funding and the participants did not pay any supplements. | PMC10007783 | ||
Availability of data and materials | The datasets used and analysed during the current study available from the corresponding author on reasonable request. The data will be anonymized. | PMC10007783 | ||
Declarations | PMC10007783 | |||
Ethics approval and consent to participate | INFILTRATION | We confirm that all methods were carried out in accordance with relevant guidelines and regulations. An informed consent was obtained for all participants before the infiltration including all the information about the procedure, the benefits and the possible risks. The trial was approved by the three Ethics Committees of ULB; the Ethics Committee of Erasme Hospital (main centre), the Ethics Committee of Saint-Pierre Hospital and the Ethics Committee of Braine l’Alleud Hospital (P2020/557, 31th of December 2020 - B4062020000221). These three hospitals are part of the ULB (Université Libre de Bruxelles). | PMC10007783 | |
Consent for publication | Not applicable. | PMC10007783 | ||
Competing interests | The authors declare no competing interests. | PMC10007783 | ||
References | PMC10007783 | |||
ABSTRACT | PMC9831626 | |||
BACKGROUND: | hernias | Robotic-assisted surgery research has grown dramatically in the past two
decades and the advantages over traditional videolaparoscopy have been
extensively debated. For hernias, the robotic system can increase
intraoperative strategies, especially in complex hernias or incisional
hernias. | PMC9831626 | |
AIMS: | hernia | This study aimed to compare the direct cost differences between robotic and
laparoscopic hernia repair and determine each source of expenditure that may
be related to the increased costs in a robotic program from the perspective
of a Brazilian public institution. | PMC9831626 | |
METHODS: | hernia | This study investigated the differences in direct costs from the data
generated from a trial protocol (ReBEC: RBR-5s6mnrf). Patients with
incisional hernia were randomly assigned to receive laparoscopic ventral
incisional hernia repair (LVIHR) or robotic ventral incisional hernia repair
(RVIHR). The direct medical costs of hernia treatment were described in the
Brazilian currency (R$). | PMC9831626 | |
RESULTS: | A total of 19 patients submitted to LVIHR were compared with 18 submitted to
RVIHR. The amount spent on operation room time (RVIHR: 2,447.91±644.79;
LVIHR: 1,989.67±763.00; p=0.030), inhaled medical gases in operating room
(RVIHR: 270.57±211.51; LVIHR: 84.55±252.34; p=0.023), human resources in
operating room (RVIHR: 3,164.43±894.97; LVIHR: 2,120.16±663.78; p<0.001),
material resources (RVIHR: 3,204.32±351.55; LVIHR: 736.51±972.32;
p<0.001), and medications (RVIHR: 823.40±175.47; LVIHR: 288.50±352.55;
p<0.001) for RVIHR was higher than that for LVIHR, implying a higher
total cost to RVIHR (RVIHR: 14,712.24±3,520.82; LVIHR: 10,295.95±3,453.59;
p<0.001). No significant difference was noted in costs related to the
hospital stay, human resources in intensive care unit and ward, diagnostic
tests, and meshes. | PMC9831626 | ||
CONCLUSION: | hernia | Robotic system adds a significant overall cost to traditional laparoscopic
hernia repair. The cost of the medical and robotic devices and longer
operative times are the main factors driving the difference in costs. | PMC9831626 | |
RESUMO | PMC9831626 |
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