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Funding | The Molecular Screening and Therapeutics (MoST) Program is funded by the Commonwealth, as well as the NSW governments via the Office of Health and Medical Research, NSW. Open Access funding enabled and organized by CAUL and its Member Institutions. | PMC10403555 | ||
Data availability | The molecular data that forms the basis for MTB recommendations are available upon reasonable request. The authors declare that the data supporting the findings of this study are available within the paper and its supplementary appendix. | PMC10403555 | ||
Competing interests | ONCOLOGY | DT as CEO of Omico, a non-profit organisation has received grants, consultancies or research support from Roche, Astra Zeneca, Pfizer, Eisai, Illumina, Beigene, Elevation Oncology, RedX Pharmaceuticals, Sun-Pharma, Bayer, Abbvie, George Clinical, Janssen, Merck, Kinnate, Microba, BioTessellate, Australian Unity, Founda... | PMC10403555 | |
Ethics approval and consent to participate | Not applicable. | PMC10403555 | ||
Consent for publication | Not applicable. | PMC10403555 | ||
References | PMC10403555 | |||
Introduction | depression | Perinatal depression is common among women living with HIV, but depression care is limited in low-resource settings. We examined (1) characteristics of women receiving Problem Solving Therapy (PST) versus antidepressant therapy (ADT), (2) treatment response by modality, and (3) correlates of treatment response. | PMC10564822 | |
Methods | depression | REGRESSION | This analysis used data from 191 Ugandan women in the intervention arm of a cluster randomized controlled trial of task-shifted, stepped-care depression treatment for pregnant women living with HIV (PWLWH). Treatment response was defined as scoring < 5 on the nine-item Patient Health Questionnaire (PHQ-9). Bivariate an... | PMC10564822 |
Results | depression, congenital defects | MINOR | Of 134 participants with depression, 129 (96%) were treated: 84 (65%) received PST and 45 (35%) received ADT. Severe depression at treatment initiation was more common in those receiving ADT (28.9% versus 4.8%, Fischer’s Exact Test < 0.001). Treatment response was higher for PST (70/84; 83.3%) than ADT (30/45; 66.7%; p... | PMC10564822 |
Discussion | depression | Both depression treatment modalities yielded high response rates in Ugandan PWLWH; ADT was well-tolerated. Our results highlight a need to build capacity to implement the stepped-care protocol for non-responders and screen for social support and interpersonal violence. | PMC10564822 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s10995-023-03741-1. | PMC10564822 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s10995-023-03741-1. | PMC10564822 | ||
Keywords | Open access funding provided by SCELC, Statewide California Electronic Library Consortium | PMC10564822 | ||
Introduction | depression, Depression | Perinatal depression is common among pregnant women living with HIV (PWLWH), with approximately one in three meeting criteria for clinical depression in sub-Saharan Africa (SSA) (Sowa, et al., While evidence-based treatments for perinatal depression exist (Yonkers, et al., To contribute to this body of evidence, we are... | PMC10564822 | |
Methods | PMC10564822 | |||
Study Design | Details of this prospective, multi-site cluster randomized controlled trial, which follows CONSORT guidelines, can be found elsewhere (Wagner, et al., | PMC10564822 | ||
Study Participants | opportunistic infections | OPPORTUNISTIC INFECTIONS | To be eligible for this study, adult PWLWH had to score > 0 on the PHQ-2, which is administered by peer mothers at all ANC visits. Potential participants were further evaluated by a nurse who applied the following inclusion criteria: (1) gestation period of 32 weeks or less, (2) medically stable without opportunistic i... | PMC10564822 |
M-DEPTH Depression Care Model | The M-DEPTH Depression Care model consisted of (1) | PMC10564822 | ||
Problem Solving Therapy (PST) | PST is a cognitive-behavioral intervention that teaches patients to use adaptive problem solving and systematically apply four skills: defining the problem, generating solutions, selecting solutions, and implementing/evaluating those solutions (Bell et al. | PMC10564822 | ||
Antidepressant Therapy (ADT) | depression | ADT was administered and monitored by nurses, beginning in the second trimester to balance benefits with risks to the developing fetus. Fluoxetine, a selective serotonin reuptake inhibitor (SSRI), at a starting daily dose of 20 mg was the first-line medication, and imipramine, a tricyclic antidepressant, at a starting ... | PMC10564822 | |
Measures | depression, Depression, respiratory distress, trauma | CONGENITAL CONDITIONS, SECONDARY | Assessments included surveys, laboratory viral load testing, pharmacy data, and data abstracted from medical charts and a Depression Care Registry maintained by peer mothers and nurses. Survey measures were interviewer-administered; those that had not been translated into Luganda, the local language, during our prior r... | PMC10564822 |
Statistical Analysis | depression | REGRESSION, SECONDARY | We used descriptive statistics to examine depression treatment response by modality (PST or ADT) and the presence of side effects. We conducted bivariate analyses to examine differences in patient characteristics between those treated with PST versus ADT, and those whose depression did or did not respond to treatment. ... | PMC10564822 |
Results | PMC10564822 | |||
Sample Characteristics | depression, SD, depressive symptoms | SECONDARY | The intervention arm consisted of 191 PWLWH (out of 391 PWLWH enrolled in the trial overall). Baseline characteristics of those in the intervention arm included mean age of 27.3 (SD = 5.7) years, 41% had any secondary education, 81% were in a committed relationship, mean gestation was 21.3 weeks (SD = 6.4), 22% were ne... | PMC10564822 |
Treatment Effects on PHQ-9 Scores | PMC10564822 | |||
Overall | depression | REMISSION | Of the 129 participants who received depression treatment with PST or ADT, 100 (77.5%) responded to treatment (PHQ-9 < 5) at some point during the study and remained in remission at the conclusion of treatment (or at study completion for those who remained on ADT).PHQ-9 scores at the start of treatment were significant... | PMC10564822 |
By Treatment Modality: Problem Solving Therapy | depression | REMISSION | Among the 84 participants who were treated with PST, the mean number of sessions attended was 5.9 (SD = 2.1; median = 6); 78 (92.9%) completed the three core sessions, and 74 of those 78 (94.9%) completed additional sessions. A total of 74 women (88.1%) responded to PST at some point in the study. Treatment response wa... | PMC10564822 |
By Treatment Modality: Antidepressant Therapy | depression | REMISSION | Among the 45 participants who received ADT, 43 (95.6%) were prescribed fluoxetine and 2 (4.4%) received imipramine; only one woman had a dosage increase of her medication. At this point in the ongoing study, mean number of months of ADT is 9.3 (SD = 4.8; range: 2 weeks to 25 months). Thirty-three women (73.3%) responde... | PMC10564822 |
Side Effects of Antidepressant Therapy | SAID | Of the 45 participants who received ADT, 40 (88.9%) provided data about side effects at the postpartum assessment. Nine participants (22.5%) reported side effects, of whom five said they were “somewhat” bothersome and 1 said they interfered “more than a little” with daily life. When asked about physical signs in their ... | PMC10564822 | |
Discussion | depression | The treatment response rate among Ugandan PWLWH receiving depression care using an evidence-based collaborative care model was high overall, consistent with other studies, (Patel, et al., Nearly all (96%) participants who were identified as having depression received treatment, and over three-quarters of treated partic... | PMC10564822 | |
Acknowledgements | The authors wish to thank the study participants and the study coordinators. They also thank Hilary Peterson and Mahlet Gizaw for their assistance with preparing this manuscript for submission. Research reported in this publication was supported by the National Institute of Mental Health (NIMH) of the National Institut... | PMC10564822 | ||
Author Contributions | Faherty: Conceptualization; Writing-Original Draft; Formal Analysis; Gwokyalya: Formal Analysis; Investigation; Data Curation; Writing-Review and Editing; Project Administration; Dickens: Writing-Review and Editing; Supervision; McBain: Writing-Review and Editing; Ngo: Writing-Review and Editing; Nakigudde: Writing-Rev... | PMC10564822 | ||
Funding | Open access funding provided by SCELC, Statewide California Electronic Library Consortium. Research reported in this publication was supported by the National Institute of Mental Health (NIMH) of the National Institutes of Health under award number R01-MH115830 (Wagner). The content is solely the responsibility of the ... | PMC10564822 | ||
Data Availability | Study data may be made available upon request. | PMC10564822 | ||
Code Availability | N/A. | PMC10564822 | ||
Declarations | PMC10564822 | |||
Conflicts of interest | The authors declare no conflicts of interest. | PMC10564822 | ||
Ethics Approval | The study protocol was approved by the institutional review boards of the RAND Corporation and Makerere University School of Public Health and the Uganda National Council for Science and Technology. | PMC10564822 | ||
Consent to Participate | Participants provided written consent. | PMC10564822 | ||
Consent for Publication | N/A. | PMC10564822 | ||
References | PMC10564822 | |||
Subject terms | affective valence | ADVERSE EVENTS, EVENTS, EVENT | Previous studies have shed light on the importance of affect in risk perception and the role of mental imagery in generating affect. In the current study, we explore the causal relationship between mental imagery, affect, and risk perception by systematically varying the level of mental imagery in three levels (i.e., e... | PMC10284903 |
Introduction | EVENTS | Every day we face different risks, everything from driving in traffic to societal issues like climate change. But what determines how we act in the face of these risks? Why do we sometimes take a leap of fate (i.e., risk seeking), and other times take the safe route (i.e., risk aversive)? The last couple of decades has... | PMC10284903 | |
Research questions and hypotheses | Specially, we aim to answer if mental imagery impacts the perceived risk of climate change; and, in addition if mental imagery is a step in the causal relationship between affective experiences and climate change related risk perception. We expected that the magnitude of the change in the dependent variables (perceived... | PMC10284903 | ||
Method | PMC10284903 | |||
Participants | Informed consent was collected from all participants. According to guidelines from the Swedish research council concerning the Ethical Review of Research Involving Humans (SFS 2003:460), approval from an ethics committee is not required for behavioral research such as this study.Data from a total of 1055 participants w... | PMC10284903 | ||
Procedure and materials | PMC10284903 | |||
Pre-manipulation measures | EVENTS, EVENT, POSITIVE | After giving consent and completing demographic variables, all participants rated the three dependent variables, perceived risk of climate change, and their affective experience in the form of valence, and arousal.The main dependent variable is the perceived risk of climate change posed to oneself (two items), to other... | PMC10284903 | |
Enhanced mental imagery task | EVENT | Participants in the enhanced mental imagery condition were presented with an environmental risk event and were then instructed to create a mental image of that risk, “[example water pollution increasing] Now, please build up a very vivid image of a lake, the sea, or a river, using all your senses. Please imagine before... | PMC10284903 | |
Visuospatial working memory interference task | EVENTS, EVENT | Participants in the prevented mental imagery condition were presented with an environmental risk event and then partook in a mental rotation task, that served the purpose of visuospatial working memory interference. The mental rotation task consisted of completing five mental rotation items. Participants received a tut... | PMC10284903 | |
Post-manipulation ratings | donation behavior | Following this, all participants rated the dependent variables again and completed some exploratory measures; pro-environmental donation behavior; pro-environmental intention; pro-environmental impact-belief; anticipated warm glow; severity of environmental risks presented in the study; personal knowledge of the place ... | PMC10284903 | |
Results | For the main analyses on perceived risk, an aggregated measure of perceived risk was used (Mean values for perceived risk, affective valence, and affective arousal, presented for pre- and post-manipulation, split per condition.The risk perception values presented are based on the average value at each time. The values ... | PMC10284903 | ||
Perceived risk of climate change | EVENT | We expected that enhancing mental imagery would lead to an increase in the perceived risk of climate change, that were of larger magnitude compared to both the spontaneous and prevented use of mental imagery (1). Subsequently, we also expected that preventing mental imagery would decrease the magnitude of change in per... | PMC10284903 | |
Affective experience | PMC10284903 | |||
Valence | affective valence, affective valence and arousal | EVENTS | Concerning affective experience, we expected that enhancing mental imagery would lead to a decrease in the level of positive affective valence of larger magnitude and a increase in the level of arousal of a larger magnitude, compared to both the spontaneous and prevented use of mental imagery (3). Subsequently, we also... | PMC10284903 |
Arousal | When comparing affective arousal in all three conditions the results revealed a main effect of time, no main effect of condition, however an interaction effect. Thus, the results indicate that the participants change in arousal level are dependent on the condition. When comparing the conditions on the reported arousal ... | PMC10284903 | ||
Pro-environmental intention and impact belief | OSF | In addition to the main research question, we posed an additional question: Is there a relationship between perceived risk and behavioral intention and/or impact belief? Two additional exploratory research questions were posed in the pre-registration (see OSF), for analyses to answer these see the | PMC10284903 | |
Discussion | affective valence | EVENTS, EVENT | The literature on affect-as-informationOur results suggest that on average positive affect decreased and risk perception of climate change increased when processing the environmental risk events. However, in line with our hypotheses, we specifically find that an increased level of mental imagery was related to a larger... | PMC10284903 |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-37195-w. | PMC10284903 | ||
Author contributions | The authors their confirm contribution to the paper as follows: study conception and design: H.K., E.A., D.V.; data collection: H.K.; analysis and interpretation of results: H.K., E.A., D.V.; draft manuscript preparation: H.K., E.A., D.V. All authors reviewed the results and approved the final version of the manuscript... | PMC10284903 | ||
Funding | Open access funding provided by Linköping University. Funding was provided by Svenska Forskningsrådet Formas (2020-02072). | PMC10284903 | ||
Data availability | The datasets generated during and/or analyzed during the current study are available in the Open Science Framework, | PMC10284903 | ||
Competing interests | The authors declare no competing interests. | PMC10284903 | ||
References | PMC10284903 | |||
Abstract | PMC9970867 | |||
Background | Hepatocellular carcinoma, malignancy, hepatocellular carcinoma, tumour | HEPATOCELLULAR CARCINOMA, HEPATOCELLULAR CARCINOMA, RECURRENCE, TUMOUR | Hepatocellular carcinoma is the sixth most common malignancy in the world. Major hepatectomy (resection of greater than or equal to three liver segments) is needed if a tumour is large or close to major blood vessels. Despite low mortality, open major hepatectomy is associated with high rates of tumour recurrence that ... | PMC9970867 |
Methods | The Asia-Pacific multicentre randomized trial of laparoscopic | PMC9970867 | ||
Results and conclusion | hepatocellular carcinoma | HEPATOCELLULAR CARCINOMA | The AP-LAPO trial will determine whether laparoscopic major hepatectomy offers oncological benefits to patients with hepatocellular carcinoma compared with open major hepatectomy. | PMC9970867 |
Registration number | NCT04852211 ( | PMC9970867 | ||
Protocol version | HCC | AP-LAPO trial version 01 (1 December 2021)The AP-LAPO trial will be the first multicentre randomized trial evaluating the long-term oncological benefits of LMH for HCC. It provides level 1 evidence on the best surgical approach of major hepatectomy for HCC. | PMC9970867 | |
Introduction | tumours, malignancy, HCC | HEPATOCELLULAR CARCINOMA, TUMOURS | Hepatocellular carcinoma (HCC) is the sixth most common malignancy in the worldOpen major hepatectomy (OMH) (resection of greater than or equal to three liver segments) is indicated for large tumours (greater than 5 cm) that are centrally located and/or close to intrahepatic major vessels. OMH is associated with signif... | PMC9970867 |
Methods | The Asia-Pacific multicentre randomized trial of laparoscopic | PMC9970867 | ||
Eligibility criteria | tumours, tumour, HCC | TUMOURS, METASTASIS, TUMOUR | Surgical procedures will be carried out by senior hepatobiliary surgeons. According to the international standard for laparoscopic liver surgery, each surgeon will need to have performed at least 55 resections classified as LMH to be included in the studyInclusion criteria consist of: a diagnosis of HCC as defined by t... | PMC9970867 |
Intervention | PENICILLIN ALLERGY | Preoperatively all patients will undergo: blood tests (complete blood count, liver and renal function, coagulation profile, serum All patients will receive prophylactic antibiotics (Augmentin (amoxicillin + clavulanate) (GlaxoSmithKline) 1.2 g intravenously for one dose or levofloxacin (Daiichi Sankyo) 500 mg intraveno... | PMC9970867 | |
Interventions: LMH | tumour | PNEUMOPERITONEUM, TUMOUR | For the LMH group, the patient will be placed in a left semi-decubitus position. Pneumoperitoneum will be created by carbon dioxide insufflation and the intra-abdominal pressure maintained at 13–15 mmHg. In addition to the camera port (10 mm), two 12-mm and two 5-mm ports will be used and adjusted according to tumour l... | PMC9970867 |
Intervention: OMH | tumour | TUMOUR | For the OMH group, resection of the tumour will be performed as previously described | PMC9970867 |
Outcomes | PMC9970867 | |||
Primary outcome | The primary outcome is 2-year recurrence-free survival. | PMC9970867 | ||
Secondary outcomes | POSTOPERATIVE COMPLICATIONS | These include 30-day, 90-day, and in-hospital mortality, postoperative complications, quality of life, time to functional recovery, 2-year overall survival, 5-year overall survival, and recurrence-free survival. Surgical stress-related cytokines serum interleukin 6 (IL-6) and immunosuppressive acidic protein (IAP) will... | PMC9970867 | |
Measurements | blood loss, hypotension | BLOOD LOSS, EVENTS | Intraoperative: operative time (measured from time of skin incision to wound suturing); blood loss; blood transfusion volumes and other blood products (platelet concentrate, fresh frozen plasma); intraoperative major events (hypotension for greater than 20 min and use of inotropes); and laparoscopic to open conversion.... | PMC9970867 |
Follow-up | intrahepatic recurrence | RECURRENCE | No adjuvant treatment will be used after surgery. All patients will be followed up every 3–6 months for up to 5 years after operation. Follow-up assessment will include: liver function (clinical assessment of Child’s grade, complete blood count, liver, and coagulation profile); recurrence (based on serum Patients with ... | PMC9970867 |
Participant timeline | Data accrual will be performed prospectively using wed-based electronic case-report forms (eCRFs) according to the protocol plan (Schedule of enrolment, interventions, and assessments of patientsQoL, quality of life; LMH, laparoscopic major hepatectomy; OMH, open major hepatectomy. | PMC9970867 | ||
Sample size | Based on a reported 2-year recurrence-free survival rate of 72 per cent after OMH | PMC9970867 | ||
Recruitment | RECRUITMENT | All patients satisfying the inclusion and exclusion criteria will be offered recruitment into the trial. Investigators will provide information on possible advantages and disadvantages of the interventions. Patients will be included only after signing written informed consent ( | PMC9970867 | |
Randomization | Preoperative randomization will be adopted on the day of admission. A total of 330 subjects will be allocated 1:1 to either the LMH group or the OMH group. The randomization schedule will be generated by the Clinical Trials Centre (CTC) of the principal investigator’s centre, prior to the start of the study. Stratified... | PMC9970867 | ||
Blinding | There will be no blinding for all recruited patients, investigators, operating surgeons, and other supporting staff. | PMC9970867 | ||
Statistical plan | tumour | SECONDARY, TUMOUR | The 2-year recurrence-free survival (primary outcome) and overall survival will be evaluated by Kaplan–Meier method and compared by the log rank test. Other secondary outcomes will be compared using the chi-squared test or Fisher’s exact test for categorical variables, and the Mann–Whitney All clinical data including p... | PMC9970867 |
Interim analyses | tumour | ADVERSE EVENTS, RECURRENCE, RECRUITMENT, TUMOUR | Patient recruitment status will be reviewed every 4 months in planned investigator meetings in which interim analyses will be carried out. If the accrual rate is slower than expected, the principal investigator and co-investigators will discuss the possible reasons and ways to improve the recruitment rate. The interim ... | PMC9970867 |
Ethics | An information sheet will be provided, and each subject will be given the opportunity to seek medical advice or to discuss the study with friends or family prior to involvement. Written informed consent will be mandatory for inclusion and patients will be free to withdraw it at any time. This study will be performed in... | PMC9970867 | ||
Dissemination plan | SECONDARY | The protocol of this trial has been registered in Clinicaltrials.gov. The final report on primary and secondary outcomes will be published upon the completion of 5-year follow-up. Both interim analysis and final analysis will be presented at local and international conferences. | PMC9970867 | |
Discussion | tumour, HCC | RECURRENCE, TUMOUR | The aim of the AP-LAPO trial is to test the hypothesis that LMH is associated with reduced surgical stress and immunosuppression compared with OMH resulting in lower tumour recurrence rates and better survival.OMH for HCC is associated with major morbidity of up to 40 per cent in high-volume centresRecent series have p... | PMC9970867 |
Trial status | RECRUITMENT | This trial received approval from the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee on 2 September 2020. The trial was registered at ClinicalTrials.gov of the US National Library of Medicine (registration no. NCT04852211) on 21 April 2021. The recruitment began in... | PMC9970867 | |
Supplementary Material | Click here for additional data file. | PMC9970867 | ||
Funding | The AP-LAPO trial has received funding from the Health and Medical Research Fund of the Food and Health Bureau of Hong Kong Special Administrative Region of China (Project no. 08190446). The funder of the trial does not have an administrative role in study design, outcome analyses, writing of the report, or decision to... | PMC9970867 | ||
Disclosure | The authors declare no conflict of interest. | PMC9970867 | ||
Supplementary material | PMC9970867 | |||
Data availability | The data set will be kept confidential until the publication of trial results in an international journal. After that, the data set will be open upon an individual party’s request. | PMC9970867 | ||
References | PMC9970867 | |||
Key Points | PMC10122174 | |||
Question | esophageal cancer | OESOPHAGEAL CANCER | Is there an association between radiotherapy (RT) duration and clinical outcomes in patients with esophageal cancer receiving definitive chemoradiotherapy? | PMC10122174 |
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