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RACIONAL: | A pesquisa em cirurgia robótica assistida cresceu dramaticamente nas últimas
duas décadas e as vantagens sobre a videolaparoscopia tradicional têm sido
amplamente debatidas. Para as hérnias, o sistema robótico pode aumentar as
estratégias intraoperatórias, principalmente em hérnias complexas ou hérnias
incisionais. | PMC9831626 | ||
OBJETIVOS: | Comparar as diferenças de custo direto entre a hernioplastia incisional
robótica e a laparoscópica e determinar cada fonte de gasto que pode estar
relacionada ao aumento de custos em um programa de robótica na perspectiva
de uma instituição pública brasileira. | PMC9831626 | ||
MÉTODOS: | hérnia | Investigar as diferenças nos custos diretos dos dados gerados a partir de um
protocolo de ensaio clínico (ReBEC: RBR-5s6mnrf). Pacientes com hérnia
incisional foram aleatoriamente designados para serem submetidos a reparo
robótico ou laparoscópico (RVIHR). Os custos foram descritos na moeda
brasileira (R$). | PMC9831626 | |
RESULTADOS: | exames diagnósticos | UTI | Dezenove pacientes submetidos à cirurgia robótica foram comparados com
dezoito submetidos à cirurgia laparoscópica. O valor gasto com tempo de
centro cirúrgico (Robótica: 2.447,91±644,79; Robótica: 1.989,67±763,00;
p=0,030), gases medicinais inalados em centro cirúrgico (Robótica:
270,57±211,51; Robótica: 84,55±252,34;... | PMC9831626 |
CONCLUSÕES: | O sistema robótico adiciona um custo global significativo à hernioplastia
incisional laparoscópica tradicional. O custo dos dispositivos médicos e
robóticos, além de tempos cirúrgicos mais prolongados, são os principais
fatores que impulsionam a diferença nos custos. | PMC9831626 | ||
HEADINGS | PMC9831626 | |||
DESCRITORES: | PMC9831626 | |||
INTRODUCTION | ventral hernia | Robotic-assisted surgery research has grown dramatically in the past two decades,
leveraged by top Gross Domestic Product (GDP) countriesSeveral comparative studies of robotic-assisted primary, inguinal, or incisional
ventral hernia repair versus laparoscopy found no significant differences in
postoperative outcomesThe... | PMC9831626 | |
METHODS | PMC9831626 | |||
Study design and participants | hernia | This study investigated the differences in direct costs from the data generated
from a randomized trial protocol (Brazilian Registry of Clinical Trials, ReBEC;
ID: RBR-5s6mnrf). The clinical outcomes of this protocol were previously reportedAll hernia repairs took place at | PMC9831626 | |
Ethical aspects | The local Ethics Committee approved the study protocol (CAAE:
40789014.3.0000.0065), and all patients signed a written informed consent
form. | PMC9831626 | ||
Costs estimation | hernia | MAY | The direct medical costs of hernia treatment are described from the Institute’s
perspective. A mixed methodology of micro-costing and apportionment of the
macro-costing was used. The estimate for daily costs related to hospitalization
and surgery (OR time, medical and multidisciplinary consultations, daily charges
in h... | PMC9831626 |
Interventional and control groups | hernia | Patients with an incisional hernia were randomly assigned to receive any
interventions: LVIHR or RVIHR, with either an intraperitoneal onlay mesh (IPOM)
or a Rives-Stoppa procedure. All robotic-assisted procedures performed in this
study used the da Vinci Si platforms. When possible, any defect was closed using
a unidi... | PMC9831626 | |
Statistical analysis | Qualitative variables were described as counts and percentages. Continuous
variables were described as mean, median, standard deviation, and 95% confidence
intervals (95%CIs). Differences between groups were assessed by the Mann-Whitney
U test for continuous variables and Fisher’s exact test or chi-square test for
cate... | PMC9831626 | ||
RESULTS | In the study, 19 patients submitted to LVIHR were compared with 18 patients submitted
to RVIHR.No significant difference was noted in costs related to hospital stay (RVIHR:
1,641.50±767.85; LVIHR: 1,749.61±1,130.48; p=0.738), inhaled medical gases (ICU)
(RVIHR: 0.00; LVIHR: 10.83±44.92; p=0.331), inhaled medical gases ... | PMC9831626 | ||
Total costs per patient (mean and standard deviation) between robotic
ventral incisional hernia repair and laparoscopic ventral incisional hernia
repair. | PMC9831626 | |||
Mean costs differences between robotic ventral incisional hernia repair
and laparoscopic ventral incisional hernia repair. | hernia | Costs were expressed as Real (R$), the monetary unit of Brazil.
RVIHR=robotic ventral incisional hernia repair; LVIHR=laparoscopic
ventral incisional hernia repair; OR: operation room; ICU: intensive
care unit; SD: standard deviation.To investigate the medications costs difference between RVIHR and LVIHR, we analyzed
t... | PMC9831626 | |
Drug vials consumed per patient. | hernia | NEUROMUSCULAR BLOCKADE | SD=standard deviation; RVIHR=robotic ventral incisional hernia repair;
LVIHR=laparoscopic ventral incisional hernia repair.Regarding drug vials consumed per patient, no significant difference was noted in
routine medications (RVIHR: 8.6±7.62 vials; LVIHR: 8.53±6.92 vials; p=0.888),
intravenous fluids (RVIHR: 17.8±11.01... | PMC9831626 |
DISCUSSION | STERILE, NEUROMUSCULAR BLOCKADE | The outcome of the present study showed that comparing RVIHR and LVIHR, there is a
significantly higher average cost in robotic-assisted use. These costs are mainly
associated with prolonged surgical time, higher consumption of anesthetics, high
mobilization of human resources, and, evidently, material devices related ... | PMC9831626 | |
CONCLUSIONS | hernia | A 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. These costs should be well known
before starting any robotic public program. | PMC9831626 | |
Central Message | hernias | CAVITY, ADHESIONS | 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. The benefits comprise
high-qua... | PMC9831626 |
Perspectives | hernia | A 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. These costs should
be well known before starting any robotic public program.How to cite this article: C... | PMC9831626 | |
REFERENCES | PMC9831626 | |||
Objectives | DISORDERS | Integrating vocational rehabilitation and mental healthcare has shown effects on vocational outcomes during sick leave with common mental disorders. In a previous paper, we showed that a Danish integrated healthcare and vocational rehabilitation intervention (INT) had a surprisingly negative impact on vocational outcom... | PMC10713989 | |
Method | A randomized, parallel-group, three-arm, multi-centre superiority trial was conducted to test the effectiveness of INT and MHC compared to SAU. | PMC10713989 | ||
Results | In total, 631 persons were randomized. Contrary to our hypothesis, SAU showed faster return to work than both INT [hazard rate (HR) 1.39, P=0.0027] and MHC (HR 1.30, P=0.013) at 24-month follow-up. Overall, no differences were observed regarding mental health and functional level. Compared to SAU, we observed some heal... | PMC10713989 | ||
Conclusion | This trial does not support the hypothesis that INT lead to faster return to work. However, implementation failure may explain the negative results. | PMC10713989 | ||
Key terms | Long-term sick leave is a risk factor for exclusion from the labor market ( | PMC10713989 | ||
Methods | Methods are reported elsewhere ( | PMC10713989 | ||
Statistical analyses | REGRESSION, SENSITIVITY | Proportion-in-work outcomes were analyzed using logistic regression and time-to-RTW outcomes using Cox-regression. Self-reported outcomes were analyzed using linear mixed-effects models. Throughout, we adhered to the intention-to-treat principle. Due to multiple testing, P-values <0.017 were considered statistically si... | PMC10713989 | |
Results | DELETION | Analyses included 636 participants in total. Participant flow. [INT=IBBIS integrated intervention; MHC=mental healthcare; SAU=service as usual; RCT=randomized controlled trial]. *Due to European data legislation, complete deletion of data was possible and was requested after randomization by 8 participants. | PMC10713989 | |
Vocational outcomes at 24-month follow-up: | PMC10713989 | |||
Limitations | Implementation issues severely limit both the internal and external validity of the study. Furthermore, due to the nature of the interventions, participants could not be blinded, and the study may be limited by some effects of the allocation procedure in itself. | PMC10713989 | ||
Implications | Complex interventions involving co-location and integration of multidisciplinary teams are generally difficult to implement ( | PMC10713989 | ||
Concluding remarks | This trial compared INT and MHC to SAU. Contrary to our initial hypothesis, both INT and MHC consistently showed significantly lower RTW rates across all follow-ups, compared with SAU. MHC yielded some short-term health benefits, but they were not sustained beyond six months. However, as we cannot rule out implementati... | PMC10713989 | ||
Ethics | The trial was registered at | PMC10713989 | ||
Supplementary material | PMC10713989 | |||
Supplementary material | PMC10713989 | |||
Acknowledgements | RECRUITMENT | The Danish Agency for Labour Market and Recruitment sponsored most of the IBBIS project, which was conducted in collaboration with the Mental Health Services in the Capital Region of Denmark. The four collaborating municipalities partly financed the salary of the employment consultants. The Danish Agency for Labour Mar... | PMC10713989 | |
References | PMC10713989 | |||
CONFLICT OF INTEREST | The authors declare no conflicts of interest.To the editor,The effect on adherence of a self‐administration medication programme was tested in a randomized controlled trial involving 60 cardiac inpatients by Hajialibeigloo et al. ( | PMC9748058 | ||
DR MORISKY AND THE MMAS | Dr Morisky has received attention over the last few years for asserting copyright over the MMAS. We counted at least six Retraction Watch posts related to Dr Morisky and his adherence scale (see, e.g. Marcus, | PMC9748058 | ||
WAS DR MORISKY GIFTED AUTHORSHIP? | Dr Morisky is listed as an author in the Hajialibeigloo et al. ( | PMC9748058 | ||
CONFLICT OF INTEREST? | The authors of the Hajialibeigloo et al. ( | PMC9748058 | ||
WHY GIFTING AUTHORSHIP MATTERS | The gifting of authorship is common; authors of an observational study of three general medical journals found that up to 20% of papers reviewed had honorary authors (Bates et al., It would be informative to understand from the trial authors why Dr Morisky was included as an author on their paper. If he made the requir... | PMC9748058 | ||
RECOMMENDATIONS | The Hajialibeigloo et al. ( | PMC9748058 | ||
DATA AVAILABILITY STATEMENT | Data sharing not applicable to this article as no data sets were generated or analysed during the current study. | PMC9748058 | ||
REFERENCES | PMC9748058 | |||
Summary | PMC7614834 | |||
Background | debilitating sequelae | ADENOVIRUS, RVF, RIFT VALLEY FEVER | Rift Valley Fever (RVF) is a viral epidemic illness prevalent in Africa that can be fatal or result in debilitating sequelae in humans. No vaccines are available for human use. We evaluated the safety and immunogenicity of a non-replicating simian adenovirus (ChAdOx1)-vectored RVF vaccine in humans. | PMC7614834 |
Methods | We conducted a phase 1 first-in-human open-label dose-escalation trial in healthy adults in the United Kingdom aged 18 to 55 years ( | PMC7614834 | ||
Findings | Between 11 | PMC7614834 | ||
Interpretation | RVF | ChAdOx1 RVF vaccine was safe, well-tolerated and immunogenic when administered as a single dose in this study population. The data support further clinical development of ChAdOx1 RVF for human use. | PMC7614834 | |
Funding | UK Department of Health and Social Care through the UK Vaccines Network; Oak Foundation; Wellcome Trust | PMC7614834 | ||
Introduction | RVF, VIRUS, ZOONOSIS, RIFT VALLEY FEVER | Rift Valley fever (RVF) is a mosquito-borne viral zoonosis that primarily affects domestic livestock (sheep, goats, cattle) and humans in Africa and the Arabian Peninsula.Natural exposure to RVF generates long-lived protective neutralising antibody (nAb) in both humans and livestock, with a modest declining of titres o... | PMC7614834 | |
Methods | PMC7614834 | |||
Study design and participants | RVF, RECRUITMENT | We conducted a phase I, first-in-human, dose-escalation, open-label, non-randomised clinical trial of ChAdOx1 RVF vaccine at the Centre for Clinical Vaccinology and Tropical Medicine, Oxford, UK. Healthy adult volunteers aged 18-55 years were recruited from the local Oxfordshire area using ethically approved advertisin... | PMC7614834 | |
Procedures | toxicity | ADVERSE EVENTS, RVF, EVENTS, BLOOD | The ChAdOx1 RVF vaccine (formerly known as ChAdOx1 GnGc) has been described previously and was manufactured by Advent Srl in accordance with current Good Manufacturing Practices as described in the Investigational Medicinal Product Dossier.Following vaccination, participants attended a series of follow-up visits at the... | PMC7614834 |
Outcomes | VIRUS, ADVERSE EVENTS, RVF, SECONDARY, APPENDIX | The primary objective of the study was assessment of safety and tolerability of the vaccine in a healthy adult population. Primary outcome measures were: occurrence of local and systemic solicited adverse events for 7 days after vaccination, occurrence of unsolicited adverse events for 28 days after vaccination, change... | PMC7614834 | |
Statistical analysis | ADVERSE EVENTS, RVF | This phase I first-in-human trial aimed to describe the safety, tolerability, and immunogenicity of ChAdOx1 RVF. The number of participants in each vaccine dose group allowed a descriptive analysis of the frequency and magnitude of adverse events following vaccination, rather than statistical significance testing for s... | PMC7614834 | |
Role of the funding source | The authors designed, executed, analysed, and reported the study. The funders had no role in these activities other than review of the proposed study design during the funding application. | PMC7614834 | ||
Results | sore throat, feverishness, upper respiratory tract symptoms, cough | ADVERSE REACTIONS, SORE THROAT, ADVERSE EVENTS, COVID-19 INFECTION, RVF | Between 2ChAdOx1 RVF was determined to have an acceptable safety and tolerability profile during interim safety reviews, allowing dose-escalation to proceed as planned. No serious adverse events occurring in any of the participants following vaccination. Mild local reactions were common, with 14 of the 15 participants ... | PMC7614834 |
Discussion | miscarriage, TTS | ADVERSE EVENTS, RVF, MISCARRIAGE, CORONAVIRUS, THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME | There are currently no vaccines for use against RVF in humans, leaving the world vulnerable to public health emergencies associated with RVF epidemics. For this reason, the WHO has prioritised development of RVF countermeasures and compiled a target product profile to guide vaccine development.A scalable manufacturing ... | PMC7614834 |
Supplementary Material | PMC7614834 | |||
Acknowledgements | PMF | MARION, VIRUS | This study was supported through the UK Vaccines Network by the UK Department of Health and Social Care (projects 16/107/02 and 16/107/03). The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health and Social Care. GMW was supported by an Oak foundation fel... | PMC7614834 |
Data Sharing Statement | Deidentified participant data will be made available upon requests directed to the chief investigator. Proposals will be reviewed and approved by the sponsor, chief investigator, and collaborators on the basis of scientific merit. After approval of a proposal, data can be shared through a secure online platform after s... | PMC7614834 | ||
Research in context | PMC7614834 | |||
Evidence before this study | RVF, RIFT VALLEY FEVER | Both the WHO and African Union have identified vaccine development for RVF in humans as an urgent priority owing to its potential to cause a public health emergency with devastating health consequences and major economic impacts. The goal of RVF vaccinology has been to design vaccines that are safe and highly immunogen... | PMC7614834 | |
Added value of this study | ADENOVIRUS, RVF, DISEASE, ADVERSE EVENTS | This study describes a first-in-human trial of ChAdOx1 RVF, a chimpanzee adenovirus vectored RVF vaccine that has been shown to be highly immunogenic and efficacious against RVF in all major livestock species affected by the disease. While the ChAdOx1 platform is widely deployed for use against COVID-19 (Oxford/AstraZe... | PMC7614834 | |
Implications of all the available evidence | RVF | A vaccine for use against RVF in humans remains an urgent unmet need. ChAdOx1 has been shown to be a scalable vaccine platform for COVID-19, but this is the first use of the platform for RVF in humans. ChAdOx1 RVF was well tolerated and generated strong humoral and cellular immune responses. Further evaluation of the v... | PMC7614834 | |
Trial Profile | PMC7614834 | |||
Humoral and cellular responses generated by ChAdOx1 RVF vaccination | RVF | ChAdOx1 RVF vaccine immunogenicity kinetics are shown for all participants (n=15) by dose allocation and at all immunology sampling timepoints during the 3 months of follow up. RVF nAb titres are shown in (A), summed Gn and Gc IFN γ ELISpot responses in (B), and total IgG response against Gc (C) and Gn (D) are shown as... | PMC7614834 | |
Baseline Characteristics | PMC7614834 | |||
Solicited adverse events within 7 days of vaccination with ChAdOx1 RVF | PMC7614834 | |||
Abstract | tumor, death, breast cancer, toxicity, PD‐L1 | CPS, TUMOR, BREAST CANCER | Pembrolizumab plus chemotherapy improved progression‐free survival (PFS) and overall survival (OS) compared with placebo plus chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple‐negative breast cancer with tumor programmed cell death ligand 1 (PD‐L1) combined positive sc... | PMC10225213 |
INTRODUCTION | cancer, Breast cancer, death | CANCER, BREAST CANCER, BREAST CANCER | Breast cancer was the leading cause of cancer among women in 2020, both globally and in Japan.Evidence has suggested that Japanese patients may have better survival outcomes following treatment than American patients with breast cancer.Pembrolizumab, a humanized anti‐programmed cell death protein 1 (PD‐1) antibody, has... | PMC10225213 |
MATERIALS AND METHODS | PMC10225213 | |||
Patient eligibility | Eligibility criteria for KEYNOTE‐355 have been previously published.The trial protocol was approved by an institutional review board or independent ethics committee at each site, and the trial was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. Written informed consent wa... | PMC10225213 | ||
Study design | As previously described,Eligible patients were randomized 2:1 in a double‐blind manner to receive pembrolizumab plus chemotherapy or placebo plus chemotherapy. Pembrolizumab 200 mg IV or saline placebo was administered every 3 weeks for up to 35 cycles (approximately 2 years). Chemotherapy comprised the investigator's ... | PMC10225213 | ||
Assessments | PD‐L1, tumor, Tumor, Cancer | ADVERSE EVENT, TUMOR, TUMOR, ADVERSE EVENT, CPS, CANCER | Tumor imaging was performed at baseline, at weeks 8, 16, and 24 from randomization, then every 9 weeks for the first year and every 12 weeks thereafter. Responses were assessed by RECIST version 1.1 by blinded independent central review. Survival was assessed every 12 weeks until withdrawal of consent or end of study. ... | PMC10225213 |
Endpoints | tumors, PD‐L1 | CPS, TUMORS | The dual primary endpoints were PFS per RECIST version 1.1 as assessed by blinded independent central review and OS in patients in the intention‐to‐treat population, patients with PD‐L1 CPS ≥10 tumors, and patients with PD‐L1 CPS ≥1 tumors. The primary endpoints were amended to include PFS and OS in patients with PD‐L1... | PMC10225213 |
Statistical analysis | Statistical considerations for the global KEYNOTE‐355 study have been previously described. | PMC10225213 | ||
RESULTS | PMC10225213 | |||
Patients | death | CPS, DISEASE CHARACTERISTIC, ONCOLOGY | Among 847 patients enrolled in the global study,Demographics and baseline disease characteristics in the intention‐to‐treat population.
Abbreviations: CPS, combined positive score; ECOG PS, Eastern Cooperative Oncology Group performance status; IVRS, interactive voice‐response system; PD‐L1, programmed cell death ligan... | PMC10225213 |
Efficacy | Tumors, death, tumors, PD‐L1 | EVENT, DISEASE, TUMORS, CPS, TUMORS | Among the 87 patients in the Japan subset, 69 (79%) had died at the time of data cutoff. In the 28 patients with PD‐L1 CPS ≥10 tumors, the median OS was 25.9 months (95% CI, 17.1 months–not reached) in the pembrolizumab plus chemotherapy group and 18.2 months (95% CI, 3.0–26.5 months) in the placebo plus chemotherapy g... | PMC10225213 |
Safety | hypothyroidism, nausea, decreased white blood cell count, anemia | HYPOTHYROIDISM, ADVERSE EVENT, ANEMIA, INFUSION REACTION | Treatment‐related AEs occurred in all 61 patients (100%) and 26 patients (100%) in the pembrolizumab plus chemotherapy and placebo plus chemotherapy groups, respectively. The most common treatment‐related AEs in both treatment groups were decreased white blood cell count (pembrolizumab plus chemotherapy, 75%; placebo p... | PMC10225213 |
DISCUSSION | toxicity, TNBC | CPS, DISEASE | In this subset analysis of patients in the phase 3 KEYNOTE‐355 study enrolled in Japan, pembrolizumab plus chemotherapy improved outcomes versus placebo plus chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC. Baseline characteristics were generally consistent among Japan... | PMC10225213 |
AUTHOR CONTRIBUTIONS | PMC10225213 | |||
FUNDING INFORMATION | Funding for this research was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. | PMC10225213 | ||
CONFLICT OF INTEREST STATEMENT | Breast Cancer | ONCOLOGY, BREAST CANCER | Masaya Hattori has received honoraria from Eli Lilly and Daiichi Sankyo. Norikazu Masuda has provided leadership to Japan Breast Cancer Research Group Association (JBCRG); has received honoraria from AstraZeneca, Chugai Pharma, Eisai, Lilly Japan, and Pfizer; and has received research funding (all to institution) from ... | PMC10225213 |
ETHICS STATEMENT | The trial protocol was approved by an institutional review board or independent ethics committee at each site, and the trial was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. | PMC10225213 | ||
PATIENT CONSENT STATEMENT | Written informed consent was obtained from all patients. | PMC10225213 | ||
PERMISSION TO REPRODUCE MATERIAL FROM OTHER SOURCES | Not applicable. | PMC10225213 | ||
Supporting information |
Table S1.
Click here for additional data file. | PMC10225213 | ||
ACKNOWLEDGMENTS | Funding for this research was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD). We thank the patients and their families and caregivers for participating in this study, along with all investigators and site personnel. Medical writing assistance was provided by Christabel Wil... | PMC10225213 | ||
DATA AVAILABILITY STATEMENT | Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD) is committed to providing qualified scientific researchers access to anonymized data and clinical study reports from the company's clinical trials for the purpose of conducting legitimate scientific research. MSD is also obligated to prot... | PMC10225213 | ||
REFERENCES | PMC10225213 | |||
Purpose | PCOS | Does follicular homocysteine predict the reproductive potential of oocytes following FSH stimulation in PCOS women? Can it be modulated by dietary interventions? | PMC10371946 | |
Methods | PCOS | This was a prospective, randomized, interventional clinical study. Forty-eight PCOS women undergoing in vitro fertilization at a private fertility clinic were randomized for a dietary supplementation providing micronutrients involved in homocysteine clearance or no treatment. The supplement was assumed 2 months before ... | PMC10371946 | |
Results | Follicular homocysteine showed a negative correlation with clinical pregnancy both in the whole population ( | PMC10371946 |
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