title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC9965201 | ||
Author Contributions | Conceptualization, L.J.R., V.M. and M.B.; methodology, L.J.R., D.M.Z., V.M., A.M.R. and M.B.; formal analysis, L.J.R., V.M., M.B. and D.M.Z.; writing—original draft preparation, L.J.R., V.M. and S.G.; writing—review and editing, S.G., V.M., D.M.Z., A.M.R., M.B. and L.J.R.; visualization, S.G. and V.M.; supervision, V.M... | PMC9965201 | ||
Institutional Review Board Statement | Ethical approval was obtained from the Helsinki Committee of Asaf Harofe Hospital (0143-16 ASF), the Israel Ministry of Health (920090057), and the Tel Aviv University Ethics Committee. | PMC9965201 | ||
Informed Consent Statement | Written informed consent was obtained from all subjects involved in the study. | PMC9965201 | ||
Data Availability Statement | The data are available from the authors upon reasonable request. | PMC9965201 | ||
Conflicts of Interest | LJR has submitted expert opinions to the Israel Supreme Court on an administrative case about smoking by neighbors and is co-PI on a grant funded by the Justice Ministry on reducing child exposure to tobacco smoke by providing parents with biomarker information. D.Z. has no conflicts of interest. S.G. served as a paid ... | PMC9965201 | ||
Objectives | To have confidence in one's interpretation of treatment effects assessed by comparing trial results to external controls, minimizing bias is a critical step. We sought to investigate different methods for causal inference in simulated data sets with measured and unmeasured confounders. | PMC9843888 | ||
Methods | The simulated data included three types of outcomes (continuous, binary, and time-to-event), treatment assignment, two measured baseline confounders, and one unmeasured confounding factor. Three scenarios were set to create different intensities of confounding effect (e.g., small and blocked confounding paths, medium a... | PMC9843888 | ||
Results | The results with the greatest extent of biases were from the raw model that ignored all the potential confounders. In scenario 2, the unmeasured factor indirectly influenced the treatment assignment through a measured controlling factor and led to medium confounding. The methods of GC, IPTW, OW, SMR, and TMLE removed m... | PMC9843888 | ||
Conclusions | The aforesaid methods can be used for causal inference in externally controlled studies when there is no large, unblockable confounding path for an unmeasured confounder. GC and OW are the preferable approaches. | PMC9843888 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12874-023-01835-6. | PMC9843888 | ||
Keywords | PMC9843888 | |||
Introduction | ECAs | RARE DISEASES | In orphan and rare diseases, single-arm trials are common given the impracticability, if not impossibility, of randomized controlled trials [Numerous methods have been proposed to handle the potential confounders in ECAs. When individual-level data are available, frequentist approaches may estimate a causal effect usin... | PMC9843888 |
Materials and methods | PMC9843888 | |||
Study design | We generated a treatment arm (e.g., single-arm trial) and an ECA (e.g., standard of care) in order to simulate an externally controlled study. Three types of outcomes – continuous, binary, and time-to-event endpoints were assessed between two arms. In order to emulate a biased ECA, both measured and unmeasured confound... | PMC9843888 | ||
Simulated dataset | We generated a data set with 20,000 individuals, which was considered as a target population. In this data set, variable From this target population, we randomly drew 3000 samples. Each sample contained 200 observations (i.e. ‘individuals’) and were randomly drawn from the target population. Also, we drew another 3000 ... | PMC9843888 | ||
True effect | REGRESSION | For assessing the various methods that obtained estimates based on samples, the true effect of treatment in the population is needed. Population level ATEs were obtained by applying regression models to estimate marginal effects in the full dataset (n = 20,000), including both measured and unmeasured confounders in the... | PMC9843888 | |
Methods for minimizing potential biases | This study explores g-computation, PS-based weighting, and TMLE methods that can be used to handle individual-level data for reducing potential biases in externally controlled studies. | PMC9843888 | ||
G-computation | G-computation is one of Robins’ g methods [ | PMC9843888 | ||
PS-based weighting | One of common PS-based weighting method is IPTW [ | PMC9843888 | ||
TMLE | death | The TMLE method puts g-computation and PS-based weighting together, which is also considered as doubly robust estimation [Last, the estimated ATE for each outcome can be calculated as follows:The TMLE method was conducted using R package “ltmle” with the default machine learning algorithms. Since the package “ltmle” ca... | PMC9843888 | |
Model comparison | All statistical analyses were conducted in RStudio (version 1.4.1717) and R (version 4.0.4). In addition to the aforementioned methods, we also conducted the analysis using a raw model, which directly estimated the treatment effects without any adjustment. In order to assess these methods, we compared the true effect w... | PMC9843888 | ||
Results | PMC9843888 | |||
Estimated ATE for binary endpoint | Similar to the results for the continuous endpoint, the mean estimated ATE (0.94) for binary endpoint from the raw model obviously deviated from the true effect (log odds ratio = 1.21) in scenario 1, and the deviation was even larger in scenario 2 & 3. As shown in Fig. Density distribution of treatment effect estimates... | PMC9843888 | ||
Estimated ATE for time-to-event endpoint | The mean estimated ATEs for time-to-event endpoint from the raw model also considerably differed from the true effects in all scenarios (e.g., log hazard ratio = -0.65 versus -0.83 in scenario 1). The mean estimated ATEs for time-to-event endpoint from g-computation, IPTW, OW, SMR, and TMLE in scenario 1 were -0.83, -0... | PMC9843888 | ||
Sensitivity analysis | When the sample size was reduced from 200 to 100, we found similar results in terms of reduction in bias associated with each method, but we observed increase of variance, which led to a larger MSEs and wider confidence intervals (supplementary file S | PMC9843888 | ||
Discussion | SECONDARY | By design, both the unmeasured confounder In scenario 1 & 2, the unmeasured confounder After adding an additional relationship between Although the same predictors were used for modeling, the g-computation had the smallest RSMEs in most of settings of this simulation study (Table TMLE is a doubly robust maximum-likelih... | PMC9843888 | |
Conclusion | In externally controlled studies, the methods of g-computation, PS-based weighting (IPTW, OW and SMR), and TMLE can be used to minimize the biases due to measured and unmeasured confounders. However, the extent of bias reduction by these methods depends on the technique used and the existence of an unblockable confound... | PMC9843888 | ||
Acknowledgements | MAY | Sai Karanam from Eliassen Group, LLC provided the R codes validation. This work was delivered as a podium presentation at ISPOR 2022, Washington, D.C., and virtual, May 15-18, and the authors thank the participants for their constructive feedback that improved the quality of the manuscript. | PMC9843888 | |
Authors’ contributions | Study concept and design: JR, PC, JC, HP & DM; Data source: JR & PC; Statistical analysis and simulation: JR, PC & JC; Manuscript draft and review: JR, PC, JC, HP & DM. The author(s) read and approved the final manuscript. | PMC9843888 | ||
Funding | This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. | PMC9843888 | ||
Availability of data and materials | The example of R codes for data simulation and analysis can be found in the supplementary file S | PMC9843888 | ||
Declarations | PMC9843888 | |||
Ethics approval and consent to participate | Ethics approval and consent to participate is not required since this study used the simulated data only. | PMC9843888 | ||
Consent for publication | Not applicable. | PMC9843888 | ||
Competing interests | The authors declare no competing interests. | PMC9843888 | ||
References | PMC9843888 | |||
Introduction and hypothesis | SUI, MUI, urinary incontinence | STRESS URINARY INCONTINENCE, URINARY INCONTINENCE | This study was aimed at investigating the long-term effectiveness of minimally invasive mid-urethral sling (MUS) surgery and at comparing the outcomes between retropubic (tension-free vaginal tape, TVT) and transobturator tape (TOT) methods in the treatment of stress urinary incontinence (SUI) and mixed urinary inconti... | PMC10506929 |
Methods | This work is a long-term follow-up study of a previous prospective randomized trial conducted in the Department of Obstetrics and Gynecology at Oulu University Hospital between January 2004 and November 2006. The original 100 patients were randomized into the TVT ( | PMC10506929 | ||
Results | TVT | Long-term follow-up data were obtained from 34 TVT patients and 38 TOT patients. At 16 years after MUS surgery, the UISS significantly decreased from a preoperative score in the TVT (11.88 vs 5.00, | PMC10506929 | |
Conclusion | TVT, MUI | Midurethral sling surgery had good long-term outcomes in the treatment of SUI and MUI with a predominant stress component. The subjective outcomes of the TVT and TOT procedures were similar after a 16-year follow-up. | PMC10506929 | |
Supplementary information | The online version contains supplementary material available at 10.1007/s00192-023-05527-z | PMC10506929 | ||
Keywords | Open Access funding provided by University of Oulu including Oulu University Hospital. | PMC10506929 | ||
Introduction | SUI, TVT, MUI, incontinence | INCONTINENCE, STRESS URINARY INCONTINENCE, URINE LEAKAGE | Stress urinary incontinence (SUI) is defined as involuntary urine leakage during physical exertion or while sneezing or coughing, whereas urge incontinence is involuntary loss of urine associated with urgency [The first-line treatment of urinary incontinence is conservative, and it includes lifestyle modifications (wei... | PMC10506929 |
Materials and methods | MUI, urinary incontinence | URINARY INCONTINENCE | This work is a 16-year follow-up study evaluating the long-term benefits of MUS surgery compared with a previous prospective randomized controlled study on 100 women suffering from SUI or MUI with a predominant stress component. The original study protocol was approved by the regional ethics committee and the present s... | PMC10506929 |
Discussion | bleeding, postoperative pain, incontinence, bladder and bowel perforation, TVT, gynecological incontinence, memory disorder, SUI, MUI | BLEEDING, INCONTINENCE, URINARY INCONTINENCE, COMPLICATIONS | This long-term follow-up study of a prospective RCT showed that MUS surgery, as a treatment for SUI and MUI with a predominant stress component, has a good long-term subjective outcome. Similar subjective outcomes were found for the TVT and TOT procedures. To the best of our knowledge, this is the first long-term follo... | PMC10506929 |
Authors’ contributions | TVT | H. Salo: project development, data collection, data analysis, manuscript writing; H. Sova: project development, data analysis, manuscript writing; J. Laru: project development, manuscript writing; A. Talvensaari-Mattila: project development, manuscript writing; T. Piltonen: project development, manuscript writing; V. N... | PMC10506929 | |
Funding | Open Access funding provided by University of Oulu including Oulu University Hospital. H. Salo has received a research grant from the Finnish Society of Gynecological Surgery. | PMC10506929 | ||
Ethics declaration | PMC10506929 | |||
Conflicts of interest | None. | PMC10506929 | ||
References | PMC10506929 | |||
Background | postoperative pain, colorectal cancer, pain | COLORECTAL CANCER | Although laparoscopic surgery provides earlier recovery, less morbidity and hospital stay, however, severe pain is still a problem after it. Duloxetine has been recently used in postoperative pain management. We tested perioperative duloxetine to evaluate its effect on patients undergoing laparoscopic colorectal cancer... | PMC10186677 |
Methods | ADVERSE EFFECTS | Sixty patients were enrolled in this study divided into two equal groups; duloxetine group each patient received an oral duloxetine capsule (60 mg) 1st dose at night before surgery, the 2nd dose 1 h preoperative, and the 3rd dose 24 h postoperative. Placebo group received placebo capsules at the same times. The cumulat... | PMC10186677 | |
Results | Duloxetine group had lower VAS scores compared to placebo group, (3 ± 0.69) VS. (4.17 ± 0.83), (2.5 ± 0.6) VS. (4.3 ± 0.9), (2.2 ± 0.7) VS. (3.9 ± 0.6), (1.6 ± 0.7) VS. (3.6 ± 0.8), (1.1 ± 0.8) VS. (3.7 ± 0.7), (0.7 ± 0.7) VS. (3.5 ± 0.8), (0.6 ± 0.7) VS. (3.5 ± 0.8) respectively, P ˂0.01. The cumulative morphine consu... | PMC10186677 | ||
Conclusions | Perioperative duloxetine had reduced postoperative pain, decreased opioid consumption, and improved the quality of recovery in patients undergoing laparoscopic colorectal surgery. | PMC10186677 | ||
Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10186677 | ||
Introduction | colorectal cancer, major depression, postoperative pain, CRC, anxiety, cancer, pain, chronic pain | CANCER, COLORECTAL CANCER, CHRONIC PAIN, ADVERSE EFFECTS | GLOBOCAN 2018 reported that colorectal cancer (CRC) is the third most deadly and fourth-most common cancer worldwide [Multi-modal analgesia is advocated for perioperative pain management, to reduce opioid use and its associated adverse effects [Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) commonly... | PMC10186677 |
Patients and methods | PMC10186677 | |||
Ethics approval and consent for participation | Cancer | CANCER | This study is a prospective, randomized, double-blinded, placebo-controlled trial. It was done after obtaining approval from both the local ethics committee and the Institutional Review Board (IRB) from the South Egypt Cancer Institute, Assuit University, Assuit, Egypt and strictly followed the regulations and amendmen... | PMC10186677 |
Participants | allergy, pain, psychiatric, abnormal liver or renal function, cancer colon | ALLERGY, DISORDERS, CANCER COLONS | The inclusion criteria were: adult patients with ASA I-III, aged 18–65 years and, scheduled for laparoscopic colorectal surgery for cancer colon. The exclusion criteria were: Patients that have an allergy to the study drug, abnormal liver or renal function tests, a chronic opioid user (> 3 months), being on gabapentin ... | PMC10186677 |
Outcome | pain | SECONDARY | The primary aim of our study is to evaluate the efficacy of perioperative duloxetine on postoperative morphine consumption after colorectal surgery. The secondary aims include its effect on VAS pain scores and postoperative quality of recovery. | PMC10186677 |
Randomization and blinding | Sixty patients were randomized by the use of a computer-generated table of random numbers in a 1:1 ratio into 2 groups and concealed in an opaque and sealed envelope. | PMC10186677 | ||
Duloxetine group | Each patient received an oral duloxetine capsule of 60 mg 12 h before surgery, the 2nd dose of 60 mg 1 h preoperative and, the 3rd dose of 60 mg 24 h postoperative. | PMC10186677 | ||
Placebo group | pain | Each patient received a placebo capsule at the same scheduled times. The placebo capsule was prepared by the hospital pharmacy to ensure that active duloxetine and placebo capsules were identical.The patient’s follow-up was conducted by an anaesthesia resident blinded to the study. The attending anaesthesiologist, surg... | PMC10186677 | |
Procedures | Anesthesia | The anaesthetic protocol was standardized for all patients. Basic monitoring (pulse oximeter, electrocardiogram, non-invasive arterial blood pressure, and end-tidal Co2) was attached. IV access was inserted and 500 ml of normal saline was given preoperative. Anesthesia was induced with fentanyl (Fentanyl Hamein, Sunny ... | PMC10186677 | |
Outcome assessments and data collection | Pain | In the PACU, the following parameters were assessed: (1) the cumulative morphine consumption in the first 48 h (as a primary outcome). (2) Pain intensity was evaluated by VAS at time intervals 0–2 h, 2–4 h, 4–8 h, 8–12 h, 12–24 h, 24–36 h, and 36–48 h. (3) Also, the quality of recovery − 40 scoring system (QoR-40) was ... | PMC10186677 | |
Statistical analysis | PMC10186677 | |||
Sample size calculation | The sample size was calculated using the G* power program. Based on a previous study [ | PMC10186677 | ||
Statistical analysis | SD, pain | IBM-SPSS 24.0 (IBM-SPSS Inc., Chicago, IL, USA) was used for data verification, coding by the researcher and analysis. The normality of data distribution among the studied groups was tested with the Shapiro-Wilk and Kolmogorov-Smirnov tests. Normally distributed continuous data were reported as means ± (SD) and were co... | PMC10186677 | |
Results | PMC10186677 | |||
Patients characteristics | cancer colon | CANCER COLONS | Sixty-six patients were assessed for eligibility to participate in the study. Four patients were inoperable and two patients refused to participate. A final sixty patients were scheduled for laparoscopic colorectal surgery for cancer colon completed this study and equally distributed in two groups (n = 30 patient per g... | PMC10186677 |
Study endpoints | PMC10186677 | |||
Primary outcome | pain | The duloxetine group had significantly lower pain scores represented by VAS score in the first 48 postoperative hours than the placebo group at all-time intervals: 0–2, 2–4, 4–8, 8–12, 12–24, 24–36 and,36–48, Mean and standard deviation (mean ± SD) (3 ± 0.69) vs. (4.17 ± 0.83), (2.5 ± 0.6) vs. (4.3 ± 0.9), (2.2 ± 0.7) ... | PMC10186677 | |
Secondary outcome | bradycardia, headache, nausea, vomiting | Total intraoperative fentanyl consumption was decreased in the duloxetine group compared to the placebo group, mean and standard deviation (mean ± SD) (25.33 ± 26.20) vs. (74.16 ± 27.45), P value ˂0.01 (Table The cumulative 48 h morphine consumption was significantly reduced in the Duloxetine group compared to the plac... | PMC10186677 | |
Discussion | postoperative pain, bradycardia, cancer, pain, headache, nausea, vomiting | ADVERSE EFFECTS, CANCER | The present trial had shown that patients subjected to laparoscopic colorectal surgery who administered three perioperative duloxetine, 60 mg 12 h preoperative, a second dose one hour preoperative, and a third dose 24 h postoperative, had a significant lower postoperative morphine consumption, intraoperative fentanyl c... | PMC10186677 |
Study limitations | chronic pain | CHRONIC PAIN | Follow up period was only 48 h postoperatively; we could not report the effect of duloxetine on chronic pain management. We did not report the effect of duloxetine on the hospital stay period or the intestinal recovery. In further studies, the third group with two doses of Duloxetine group could be added to detect the ... | PMC10186677 |
Acknowledgements | Not applicable. | PMC10186677 | ||
Author contributions | HAE | RECRUITMENT | DFH: Statistical analysis and writing of manuscript and revision; MAM: Study design; HAE: Study design; MIA: Patient recruitment, the conduct of the study, data collection; NAE: Data entry and Statistical analysis; SMK: Conduct of study, writing of manuscript and revision. All authors read and approved the final manusc... | PMC10186677 |
Funding | The Authors certify that no funding has been received for the conduct of this study.Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10186677 | ||
Data Availability | The database is closed and there is no public access. However, permission to access and use the database can be obtained if necessary by request to the corresponding author. | PMC10186677 | ||
Declarations | PMC10186677 | |||
Ethics approval and consent for participation | Cancer | CANCER | It was done after obtaining approval from both the local ethics committee and the Institutional Review Board (IRB) from the South Egypt Cancer Institute, Assuit University, Assuit, Egypt and strictly followed the regulations and amendments of Helsinki Declaration. Informed written consent was obtained from all patients... | PMC10186677 |
Consent for publication | Not applicable. | PMC10186677 | ||
Competing interests | The authors have no conflicts of interest related to this article. | PMC10186677 | ||
Abbreviations | American Socity of Anesthesiology physical status classificationConfident intervalColorectal cancerInstitutional Review Board.Interquartil rangeModified Observer’s Assessment of Altreness/ Sedation ScaleNon steroidal antiinflammatory drugsSeretonin-norepinephrine reuptake inhibitor.Patient controlled analgesiaPostanest... | PMC10186677 | ||
References | PMC10186677 | |||
Background | depression, depressive symptoms | Although many conventional healthcare services to prevent postpartum depression are provided face-to-face, physical and psychosocial barriers remain. These barriers may be overcome by using mobile health services (mHealth). To examine the effectiveness of mHealth professional consultation services in preventing postpar... | PMC10294407 | |
Methods | This study included 734 pregnant women living in Yokohama city who could communicate in Japanese, recruited at public offices and childcare support facilities. The participants were randomized to the mHealth group (intervention, | PMC10294407 | ||
Results | Most women completed all questionnaires ( | PMC10294407 | ||
Conclusions | depressive symptoms | Local government-funded mHealth consultation services have a preventive effect on postpartum depressive symptoms, removing physical and psychological barriers to healthcare access in real-world settings. | PMC10294407 | |
Trial registration | UMIN-CTR identifier: UMIN000041611. Registered 31 August 2021. | PMC10294407 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12916-023-02918-3. | PMC10294407 | ||
Keywords | PMC10294407 | |||
Background | depression, Depression | DISORDER | Depression during the perinatal period is a common disorder in many countries and an estimated global prevalence of postpartum depression (PPD) is 17.7% [Although screening and preventive interventions for depression during the perinatal period have been recommended and implemented [Using mobile wireless technologies f... | PMC10294407 |
Methods | PMC10294407 | |||
Trial design and participants | RECRUITMENT, EARLY PREGNANCY | We conducted a trial in Yokohama, an urban city with the largest population size (about 3.8 million) among all municipalities in Japan, where conventional free face-to-face perinatal care services for all mothers were implemented. We enrolled participants from September 1, 2020–March 7, 2021. Initially, we recruited wo... | PMC10294407 | |
Randomization and masking | Participants were randomly assigned (1:1 allocation) to either the mHealth or usual care group. We used a simple randomization computer algorithm without any options, aiming to balance the baseline characteristics. After the submission of participation agreement forms, assignment information was immediately provided to... | PMC10294407 | ||
Intervention | depression | The intervention was mHealth consultation services provided by Kids Public, Inc. The service provider had developed and offered mHealth consultation services in other regions but never investigated the effectiveness of their services in preventing depression before this study. Participants in the mHealth group could co... | PMC10294407 | |
Outcomes measures | Depression, depressive symptoms | SECONDARY | The primary outcome was the risk of elevated postpartum depressive symptoms, which was assessed using the Japanese version of the Edinburgh Postnatal Depression Scale (EPDS) [The secondary outcomes were self-efficacy, loneliness, perceived barriers to healthcare access, and the use of medical facilities. Self-efficacy ... | PMC10294407 |
Statistical analysis | depressive symptoms | The target sample size was 720 pregnant women, with 360 in each group, to detect an absolute difference of 7% in the risk of elevated postpartum depressive symptoms three months after childbirth between the groups. This calculation was based on the preliminary data of mothers using mHealth services in Yokohama city (pr... | PMC10294407 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.