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Interview results
PMC10576350
Reasons for accepting or declining randomisation
’d
INVASIVE CANCER
Interviews took place a median of 22 days after randomisation. During the interview, the women were given the opportunity to elaborate further on the reasons they had given on the CTQ for accepting or declining randomisation. The three most frequent reasons for accepting randomisation were the same for this subset of 8...
PMC10576350
Information provision
DCIS, SHOCKED
For 83/89 (93%) acceptors who were interviewed, the trial had been discussed with more than one HCP, including research nurses (82/89, 92%), surgeons (75/89, 84%), radiologists (11/89, 12%), and an oncologist (1/89, 1%). Most acceptors (83/89, 93%) did not feel that their decision to take part had been influenced by th...
PMC10576350
Sites
word carcinoma, cancer’
DCIS, RECRUITMENT
Initially, four communication workshops were held, two in London, one in Birmingham and one in Wycombe, with a total of twenty delegates attending. Two further workshops, both in London, held as part of the Recruitment Recovery Plan, were attended by 17 health care professionals. The delegates were a mixture of trial c...
PMC10576350
Discussion
cancer
DCIS, CANCER, RECRUITMENT
From the outset of the LORIS study, it was anticipated that recruitment might be difficult because the two arms (conventional treatment and active monitoring with annual mammography) could be perceived as comparing ‘something’ with ‘nothing’ [Since the LORIS trial opened to recruitment, a Cochrane review highlighting f...
PMC10576350
Limitations of the study
Some women declined to take part in the study when first approached. Data were not collected from these individuals and it may be that their reasons for declining trial entry were different from those women who declined randomisation. The number of women who declined participation when first approached about the study ...
PMC10576350
Conclusions
RECRUITMENT, RECRUITMENT
Recruitment to LORIS was challenging despite employing recommended strategies aimed at patients and site staff which were well received by both groups, and improved staff knowledge and confidence. A more flexible approach to information provision, tailoring to individual needs and preference, would support informed dec...
PMC10576350
Acknowledgements
Samantha Brace-McDonnell
EVANS, STUART, FRANCIS
We would like to thank all the women who took the time to complete questionnaires and take part in the telephone interviews. The late Professor Adele Francis and the late Maggie Wilcox were responsible for the original concept design and launch of the LORIS trial.LORIS Trial Management Group members: John M. S. Bartlet...
PMC10576350
Authors’ contributions
SW carried out the analyses and produced the first draft. LM performed the patient interviews. VJ and LF led the work described in this paper and made substantial contributions to the conception and design of the trial. SM managed the data. DR, MGW, SP and CG made substantial contributions to the conception and design ...
PMC10576350
Funding
The study was funded by the National Institute for Health Research HTA Programme (11/36/16). MGW was supported by the NIHR Cambridge Biomedical Research Centre (BRC-1215-20014). Department of Health Disclaimer: The views expressed are those of the authors and not necessarily those of the Department of Health and Social...
PMC10576350
Availability of data and materials
The datasets used and analysed during the current study are available from the corresponding author on reasonable request.
PMC10576350
Declarations
PMC10576350
Ethics approval and consent to participate
WEST
LORIS was approved by the West Midland Solihull Ethics Committee (Ref: 14/WM/0083) and NHS R&D permissions obtained for each participating centre. The study was sponsored by the University of Birmingham. All participants provided written informed consent.
PMC10576350
Consent for publication
Not applicable.
PMC10576350
Competing interests
Not applicable.
PMC10576350
References
PMC10576350
1. Introduction
Lower extremity arterial occlusive disease, LEAOD
ATHEROSCLEROSIS, ARTERIAL OCCLUSIVE DISEASE
Lower Extremity Arterial Occlusive Disease (LEAOD) is a prevalent condition affecting many patients worldwide, which requires careful management and patient cooperation. This study aimed to evaluate the effectiveness of holistic nursing interventions based on the Fast Track Surgery (FTS) concept in patients with LEAOD....
PMC10713153
2. Methods
PMC10713153
2.1. Study design and population
necrosis, lower extremity infection, mental illness, liver and kidney dysfunction, septicemia, edema, heart valve disease, LEAOD, sepsis, injury syndrome
ULCERATION, SEPTICEMIA, DISEASE COURSE, EDEMA, DISEASE, HEART VALVE DISEASE, ACUTE CORONARY SYNDROME, NECROSIS, SEPSIS
This research was approved by the Medical Ethics Committee. A retrospective analysis was performed on 92 patients with LEAOD admitted to our vascular surgery department from November 2020 to December 2022. Patients were divided into a control group and an experimental group, each consisting of 46 individuals (Fig. Flow...
PMC10713153
2.2. Nursing interventions
PMC10713153
2.2.1. Control group.
Conventional rehabilitation nursing interventions were implemented. The department’s head nurse supervised these interventions, which were conducted by the responsible nursing staff. Patients were informed about the disease-related knowledge and were guided through preoperative examinations, intraoperative coordination...
PMC10713153
2.2.2. Experimental group.
lower extremity arterial occlusive disease, voice, knee joints
A holistic rehabilitation nursing intervention based on the FTS concept was implemented. A rehabilitation nursing team was established, including a senior resident physician specialized in vascular surgery, a head nurse, 4 specialist responsible nurses, and a rehabilitation therapist. The nursing staff utilized academi...
PMC10713153
2.3. Outcome measures and evaluation criteria
adherence behavior
Patient adherence was assessed before and after the intervention using a self-made hospital survey that evaluated dimensions such as balanced diet, persistent exercise, regular medication, and regular reviews. Each dimension had a maximum score of 25, with the total score positively correlated with adherence behavior (...
PMC10713153
2.4. Statistical analysis
±
Data obtained was analyzed using SPSS 26.0. Measurement data was expressed as mean ± standard deviation (x ± s), and comparisons were made using the
PMC10713153
2.5. Treatment satisfaction assessment
To evaluate the level of patient satisfaction with the implemented nursing interventions, a treatment satisfaction survey was utilized post-intervention. This tool was designed to measure patients’ satisfaction in 3 distinct categories: (1) satisfied: This category captured the patients who felt that the nursing interv...
PMC10713153
3. Results
PMC10713153
3.2. PSQI comparisons at different time points
Overall, there were statistically significant differences in the PSQI scores between the groups, at different time points, and in the interaction effect (Comparative analysis of PSQI scores in experimental and control groups at different time points.Compared to this group’s Post-Intervention 3d, Compared to this group’...
PMC10713153
4. Discussion
lower extremity arterial occlusive disease, LEAOD
DISEASE
The implementation of holistic nursing interventions, under the guidance of the FTS concept, represents an innovative patient-centered approach to rehabilitation planning and care.Leveraging modern information technologies, healthcare professionals can transform disease-related knowledge into a more engaging and visual...
PMC10713153
5. Conclusions
lower extremity arterial occlusive disease
In conclusion, our study underscores the potential benefits of integrating holistic nursing interventions based on the FTS concept for patients with lower extremity arterial occlusive disease. These interventions significantly improved patient adherence and sleep quality, thereby potentially enhancing postoperative rec...
PMC10713153
Acknowledgments
We appreciate the cooperation and informed consent provided by the patients for this study.
PMC10713153
Abbreviations:
lower extremity arterial occlusive disease
WEST
Fast Track Surgerylower extremity arterial occlusive diseasePittsburgh Sleep Quality IndexWritten informed consent for publication was obtained from all patients and their families included in this retrospective analysis.All methods of this study were carried out in accordance with relevant guidelines and regulations, ...
PMC10713153
References
PMC10713153
INTRODUCTION:
cirrhosis
EVENTS, CIRRHOSIS
The efficacy of targeted albumin therapy in the management of decompensatory events in cirrhosis is unclear, with different reports showing conflicting results. It is possible that only certain subgroups of patients may benefit from targeted albumin administration. However, extensive conventional subgroup analyses have...
PMC10299770
METHODS:
cirrhosis
CIRRHOSIS
This is a substudy of the ATTIRE trial, a multicenter randomized trial conducted to assess the effect of targeted albumin therapy in cirrhosis. Baseline serum bilirubin, albumin, sodium, creatinine, CRP, white cell count (WCC), international normalized ratio, heart rate, and blood pressure of 777 patients followed up f...
PMC10299770
RESULTS:
end-stage liver disease
Overall network connectivity and deviations along the WCC-CRP axis predicted 6-month survival independent of age and model for end-stage liver disease in the standard care arm. Patients with lower deviation along the WCC-CRP axis showed lower survival in response to targeted albumin administration over a 6-month follow...
PMC10299770
INTRODUCTION
sepsis, deaths, liver disease
SEPSIS, DISEASES, LIVER DISEASE, SPONTANEOUS BACTERIAL PERITONITIS
There has been an epidemic of liver disease during the past 50 years in the United Kingdom, with a 4-fold increase in liver-related deaths (Other clinical trials of albumin infusion have shown conflicting results. For instance, a meta-analysis of albumin use in patients with spontaneous bacterial peritonitis reported s...
PMC10299770
METHODS
PMC10299770
Study population
DECOMPENSATED CIRRHOSIS
This is a substudy (and extension) of the ATTIRE trial, which was a randomized controlled trial of targeted albumin infusions vs standard care involving 777 patients hospitalized with decompensated cirrhosis from 35 hospitals across England, Wales, and Scotland (2016–2019) (
PMC10299770
Parenclitic network analysis
REGRESSION
Parenclitic network analysis is a novel static network analytical method (Schematic representation of the network mapping method used in this study for the reference population (top panel) and individual patients (lower panel). Top panel: The correlation between a pair of biomarkers (e.g., A-B, A-C, or B-C) was used fo...
PMC10299770
Statistical analysis
REGRESSION, EVENT
Statistical analysis was performed using Stata statistical software (Stata/MP, Version 17.0) and SPSS Statistics 26 (IBM Corp., Armonk, NY), with data presented as median and interquartile range (IQR) or mean ± SD. A 2-tailed Initially, we performed the Mann-Whitney Receiver operating curve (ROC) analyses were performe...
PMC10299770
RESULTS
PMC10299770
Patient characteristics at ATTIRE trial entry
NAFLD, end-stage liver disease
NONALCOHOLIC FATTY LIVER DISEASE, VIRUS, HEPATITIS C
A total of 397 of 777 (51%) patients received standard care and were subjected to parenclitic analysis. During the 6-month follow-up period, 119 (30%) of these patients died. Table Demographic and baseline clinical variables in the study populationThe bold entries indicate HCV, hepatitis C virus; IQR, interquartile ran...
PMC10299770
Parenclitic indexes at ATTIRE trial baseline (prealbumin treatment) predict survivors and nonsurvivors at 6 months
end-stage liver disease
The correlation network maps show that survivors had a significantly higher association between the baseline clinical variables compared with nonsurvivors (Figure Correlation network map of survivors (Differences in parenclitic indexes between survivors and nonsurvivors who received standard care in the studied populat...
PMC10299770
Prognostic values of baseline parenclitic indexes to predict 6-month outcome
end-stage liver disease
REGRESSION
According to our univariate Cox regression analysis, greater parenclitic deviations along WCC-Na, Bil-WCC, WCC-CRP, HR-Bil, and INR-Bil axes were all associated with an increased risk of 6-month mortality (Table Result of univariate Cox regression analysis for parenclitic indexesThe bold entries indicate parenclitic in...
PMC10299770
Independent prognostic values of baseline parenclitic indexes to predict 6-month outcome
end-stage liver disease
REGRESSION
Multivariate Cox regression was performed to assess whether parenclitic indexes that individually predicted 6-month mortality had a prognostic value independent of age and MELD. Parenclitic deviations along the WCC-CRP axis (hazard ratio, 95% CI = 1.112, 1.053–1.174) and Bil-WCC axis (hazard ratio, 95% CI = 1.062, 1.01...
PMC10299770
Receiver operating characteristic curve values of baseline parenclitic indexes to predict 6-month outcome
end-stage liver disease
The area under the receiver operating characteristic (ROC) curves (AUC), cutoffs, and the sensitivity, specificity, positive and negative predictive values, and Brier scores of these cutoffs are presented in Table Area on the ROC curves, sensitivity, specificity, PPV, NPV, and Brier score of parenclitic indexes in comb...
PMC10299770
Assessment of the prognostic value of baseline parenclitic indexes to differentiate between 6-month outcomes comparing standard care with targeted albumin therapy
REGRESSION
The result of multivariate Cox regression for the interaction of targeted albumin treatment with baseline parenclitic variables to predict 6-month survival showed that measures of global parenclitic network characteristics (i.e., diameter and mean shortest path length), WCC-CRP parenclitic deviation, baseline serum alb...
PMC10299770
DISCUSSION
Leukopenia, decompensation, cirrhosis, decompensated cirrhosis, MELD-plus, acute-on-chronic liver failure, dyscoordination
SYSTEMIC INFLAMMATORY RESPONSE, DECOMPENSATED CIRRHOSIS, LEUKOPENIA, DISEASE, CIRRHOSIS, PATHOPHYSIOLOGY, EVENTS, COMPLICATIONS, INFLAMMATORY RESPONSE
Our parenclitic network analyses using baseline clinical data accurately predict outcome in patients with decompensated cirrhosis hospitalized for acute complications, based on disruption of organ system coupling. These analyses also identified that patients with preserved organ system coupling had significantly poorer...
PMC10299770
REFERENCES
PMC10299770
Introduction
deaths, prostate tumor, prostate cancer, tumor
TUMOR, RECURRENT PROSTATE CANCER, PROSTATE TUMOR, TUMOR ANGIOGENESIS, PROSTATE CANCER
Approximately 268,000 men are expected to be diagnosed with prostate cancer in USA in 2022 resulting in 34,500 deaths [Men with locally recurrent prostate cancer after definitive radiotherapy have few therapeutic options that can potentially eliminate the tumor with acceptable safety. Other than expectant management an...
PMC10503775
Results
PMC10503775
Study design and patient baseline characteristics
ADENOVIRUS, RECURRENT PROSTATE CANCER
All patients had recurrent prostate cancer following at least one cycle of radiation therapy. Patients received an intraprostatic injection of the Ad5-IL-12 adenovirus on day 1 at doses ranging from 1 × 10
PMC10503775
CONSORT flow diagram.
Total of 60 subjects were accessed for eligibility, out of which 44 were excluded and 1 declined to participate. Remaining 15 subjects participated in this phase-1 clinical study. The subjects were recruited in five different cohorts (n = 3) who were administered with increasing doses of the Ad5-yCD/
PMC10503775
Treatment schema.
Subjects underwent a series of pretreatment evaluations and met all the eligibility criteria before enrolled in the study. Subjects received a single intraprostatic injection of the Ad5-yCD/
PMC10503775
Toxicities
nausea, diarrhea, fatigue, leukopenia, anemia, lymphopenia, chills
ADENOVIRUS, LEUKOPENIA, ADVERSE EVENTS, ANEMIA, LYMPHOPENIA
By the study endpoint (day 30), a total of 115 adverse events (AEs) were documented. Ninety-two percent of the AEs were grade 1 (mild) and grade 2 (moderate). Several of treatment-related AEs could be either attributed to Ad5-IL-12 adenovirus (flu-like symptoms, chills, fatigue, altered liver enzyme AST/ALT ratio) or t...
PMC10503775
Adverse events in all cohorts in Ad5-IL-12 gene therapy trial.
toxicity
ADVERSE EVENTS, ADVERSE EVENT
All the Adverse events (AEs) collected through primary toxicity endpoint (day 30) are collected and are arranged by method of collection. No adverse events measured for Patient #3 due to consent withdrawal.
PMC10503775
Experimental endpoints
ADENOVIRUS
We evaluated the persistence of the adenoviral DNA in patient’s blood as a measure of the viral replication. Presence of Ad5-IL-12 adenoviral DNA detected in patient blood 7–10 days after adenoviral administration suggests potential viral replication (at the site of injection). The viral load was measured by PCR for a ...
PMC10503775
PCR of Ad5-IL-12 adenoviral DNA in blood.
POSITIVE
Ct, is the positive control. Positive control DNA was isolated blood of a healthy donor spiked with Ad5-yCD/
PMC10503775
Cytokine response
We measured the levels of IL-12 in patient’s blood after Ad5-IL-12 adenoviral injection. Since IL-12 secretion causes IFN-γ production by NK, NKT, activated CD4+ Th and CD8+ Tc cells and subsequently CXCL10 by monocytes, fibroblasts, and endothelial cells, the expression levels of IFNγ and CXCL10 were also measured. Th...
PMC10503775
Peak cytokine day and concentration.
VIRUS
Mean serum cytokines, IL-12, IFN-γ and CXCL10, from patients grouped by cohort showed a general trend that patients exhibited increased serum cytokine levels with higher virus doses (
PMC10503775
Changes in serum IL-12, IFNγ, and CXCL10 levels in each cohort.
Cytokines
ADENOVIRUS
Patient blood was drawn within 30 days of the Ad5-IL-12 adenoviral injection or on the day of adenovirus injection prior to the procedure (day 0) and on the days as described in the clinical protocol (up to day 24). Cytokines were measured by ELISA based on cytokine specific standard curves (IL-12 0–500 pg/mL; CXCL10 a...
PMC10503775
Changes in serum IL-12, IFNγ, and CXCL10 in subjects # 12 and 13.
Cytokines
Cytokines were measured by ELISA based on cytokine specific standard curves (IL-12 0–500 pg/mL; CXCL10 and IFNγ 0–1,000 pg/mL). Panels
PMC10503775
Shift in CD4
PROLIFERATION, BLOOD
The effect of the Ad5-IL-12 gene therapy on immune system activation was evaluated by analyzing circulating PBMCs by flow cytometry. Patient blood was obtained at least once before the Ad5-IL-12 gene therapy administration (baseline) and on follow-up days as described in the clinical protocol. Blood was processed on th...
PMC10503775
Peripheral blood mononuclear cell (PBMC) counts and markers for patient # 12 and 13.
ADENOVIRUS, BLOOD
Blood was drawn before and after adenovirus injection on indicated days. Blood was processed, PBMCs were harvested, stained and quantitated by flow-cytometry as described in Materials and Methods. All the data are plotted as mean fold-increase over pre-adenoviral injection (baseline). Natural killer cells (NK), T-helpe...
PMC10503775
Change in PSA levels
VIRUS
PSA levels were measured from the patients before and after the virus injection. Eight of 15 (53.3%) subjects exhibited ≥20% reduction in PSA just after the initiation of gene therapy (
PMC10503775
Change in patient PSA in response to gene therapy.
PSA doubling time (PSADT) for all the patients were estimated before gene therapy (PSADT.PRE) and after adenoviral injections (PSADT.POST). Mean, median, minimum, and maximum PSADT are tabulated (
PMC10503775
PSA through primary toxicity endpoint (day 30).
ADENOVIRUS
Ad dose: Adenoviral dose, PSA FU: PSA follow up, T to PreTx: Time (month) before the start of androgen suppression therapy, % PSA decline: PSA decline for each patient within 30 days of oncolytic adenoviral injection; NR: Not reported, NE: Not estimated, AST: Androgen suppression therapy, #: Patient 3 withdrew the cons...
PMC10503775
Discussion
toxicities, pancreatic cancer
RECURRENT PROSTATE CANCER, PANCREATIC CANCER, PROSTATE CANCER, PROSTATE ADENOCARCINOMA
The goal of this phase-1 clinical study was to estimate the maximum tolerated dose of oncolytic, cytotoxic Ad5-IL-12 gene therapy in men with recurrent prostate adenocarcinoma. Patients were administered increasing doses of Ad5-IL-12, ranging from 1 × 10Investigators from our institution have successfully carried out f...
PMC10503775
Materials and methods
PMC10503775
Study design
toxicity, prostate adenocarcinoma
RECURRENT PROSTATE CANCER, SECONDARY, PROSTATE ADENOCARCINOMA
The study was designed as a single site, prospective, non-randomized, phase I, classical 3+3 dose escalation trial of viral particles (vp). This trial was designed to enroll 15–30 men with locally recurrent prostate cancer after definitive radiotherapy under 5 cohorts with increasing doses. Each cohort of three patient...
PMC10503775
Patient selection and eligibility criteria
ventricular arrhythmia, respiratory illness, malignancy, cancer, non-melanoma skin cancer, impaired immunity, prostate, COPD, viral infections, active co-morbidity, hepatitis, prostate cancer
ACUTE INFECTION, RECURRENCE, METASTASIS, VENTRICULAR ARRHYTHMIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CANCER, DISEASE, VIRAL INFECTION, METASTATIC DISEASE, PROSTATE, COPD, HEPATITIS, CONGESTIVE HEART FAILURE, HEART, DISEASES, PROSTATE CANCER
Patients were required to have biopsy proven local recurrence of prostate cancer at least one year after the completion of definitive radiation therapy. The biopsy must have been performed within 180 days of study registration. Serum PSA < 100 ng/ or evidence of biologically active disease as demonstrated by an unequiv...
PMC10503775
Design and manufacturing Ad5-yCD/
The design and construction of the replication-competent Ad5-yCD/
PMC10503775
Pretreatment planning and injection of Ad5-yCD/
cancer, prostate
ADENOVIRUS, CANCER, PROSTATE, BLOOD
Informed consent was obtained from all patients before study-specific procedures were initiated. Pretreatment planning included transrectal ultrasound guided needle biopsy of the prostate and computerized tomography (CT) simulation. Transrectal ultrasound scan (TRUS)-guided biopsy cores (≥ 6 cores) were taken to map th...
PMC10503775
Prodrug administration
Prodrugs were administered on an outpatient basis. 5-Fluorocytosine (Ancobon; Roche Laboratories, Basel, Switzerland) was administered orally beginning on day 3 and continued for 1 week (7 days). A total of 150 mg/kg/day was given in four equally divided doses. Valganciclovir (Valcyte; Roche Laboratories) was administe...
PMC10503775
Patient monitoring
toxicity, Toxicities, Toxicity, Cancer
ADVERSE EVENTS, ADENOVIRUS, CANCER
Toxicity assessments were performed once a week prior to the start of chemotherapy (first 3 weeks) and then at scheduled follow-up visits at 3, 6, 9, 12, 18, and 24 months. Toxicities were graded using the National Cancer Institute’s Common Toxicity Criteria, CTCAE v.4.03. Case report forms (CRFs) specifically designed...
PMC10503775
PCR of Ad5-yCD/
ADENOVIRUS, BLOOD
Blood was obtained before the adenovirus injection and at least once a week after for semi-quantitative determination of adenoviral DNA in blood. Total genomic DNA was isolated from 2.5–3 mL of blood using Qiagen columns following the protocols recommended by the manufacturer (QIAGEN GmbH, Hilden, Germany). 2–3 μL of e...
PMC10503775
Serum cytokines
BLOOD
IL-12, IFNγ and CXCL12 were measured in patient serum. Blood was drawn once pretreatment (between days −30 and −1) and then again on days +3, +7, +14, +21 and +28 (±3 days) to isolate serum and collect PBMCs. ELISA was performed following manufacturer’s protocol (BD Biosciences). For measuring CXCL10, serum samples wer...
PMC10503775
Flow cytometry
Flow cytometry was performed as previously described [
PMC10503775
Statistical methods
MIN
ADENOVIRUS, ADVERSE EVENT
Adverse events, graded using CTCAE v4.03, were collected through day 30 (day 1 being the day of the adenovirus injection). The effect of oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy on serum PSA levels was evaluated by estimating PSA doubling time (PSADT). PSADT was estimated for each patient pre-inje...
PMC10503775
Supporting information
PMC10503775
An estimation of peripheral blood mononuclear cells (PBMCs) for all cohorts.
(DOCX)Click here for additional data file.
PMC10503775
Serum PSA counts in all subjects over time.
(DOCX)Click here for additional data file.
PMC10503775
Phase 1 trial of oncolytic adenovirus-mediated cytotoxic and interleukin 12 gene therapy for locally recurrent prostate cancer after definitive radiotherapy.
(PDF)Click here for additional data file.
PMC10503775
Request for planned change(s).
(PDF)Click here for additional data file.The authors thank Yingshu Zhang for technical assistance and Dr. Kevin Bobbitt for running the samples for flow cytometry.
PMC10503775
References
PMC10503775
Subject terms
human behaviors
People judge the nature of human behaviors based on underlying intentions and possible outcomes. Recent studies have demonstrated a causal role of the right temporoparietal junction (rTPJ) in modulating both intention and intention-based outcome evaluations during social judgments. However, these studies mainly used hy...
PMC9870900
Introduction
intention-oriented attribution
People judge the nature of individual behaviors not only relying on the outcomes caused by their behaviors but also on the underlying intentions. Studies have shown a transition from outcomes-oriented to intention-based moral judgment from children to adults in the normal populationTranscranial direct current stimulati...
PMC9870900
Materials and methods
PMC9870900
Participants
In a single-blinded, sham-controlled design, sixty-two college students (20.42 ± 1.9 years, 49 females) were recruited and randomly assigned to one of the three stimulation groups with anodal (n = 21), cathodal (n = 20), or sham (n = 21). We set the sample size based on previous studies on the effects of rTPJ stimulati...
PMC9870900
Experimental paradigm and procedure
anxiety
A modified dictator game (see also Ref.(All participants underwent two blocks, a pre-stimulation (baseline) block, and a post-stimulation block, with 27 trials (3 intention conditions × 9 offer levels) in each block. The pre-stimulation block was presented without any tDCS stimulation. The post-stimulation block follow...
PMC9870900
tDCS protocol
The stimulation was administered through a battery-driven constant current stimulator developed by Soterix Medical, America. The stimulation was induced through a saline-soaked pair of surface sponge electrodes. Both anodal and cathodal electrodes were 5 cm × 7 cm in size. To stimulate the rTPJ, the anodal or cathodal ...
PMC9870900
Data analysis
All analyses were performed using SPSS Version 23. The allocation amounts were categorized into three conditions: good (more than 6 ¥), fair (6 ¥) and bad (less than 6 ¥), which was also indicated in another paper
PMC9870900
Results
anxiety
To make sure that three groups are comparable across conditions, we first checked the demographic information. Overall, no significant differences in terms of the age were observed among the three stimulation groups, Ages and emotion scores for tDCS groups (mean ± SD).tDCS effects across experiments. Cathodal tDCS over...
PMC9870900
Discussion
In our research, we orthogonalized good/bad intention and good/bad outcome. We found that cathodal tDCS over the rTPJ diminished the goodness ratings towards good/bad outcomes when the intentions are good and showed no difference with ratings under bad/unknown intentions. Our results provide the first evidence that dea...
PMC9870900
Dissociation of intention and outcome
In our study, no main effect of outcome valence was observed. The judgment difference we have observed in a baseline condition are mainly driven by the intention-oriented attribution, suggesting that goodness ratings were mainly driven by intention. It is possible that participants may show strong demanding prosocial c...
PMC9870900
Comparison with previous studies
First and foremost, we have observed a largely reduced role of the intention on social judgments after inhibiting the rTPJ. Similar impairment on intention attribution was also observed in others’ studiesThe second difference from previous studies is that no modulatory effects on the intention attribution were observed...
PMC9870900
Context-based intention modulation
EVENT
Besides the essential role for intention and outcome processing, the rTPJ was also implicated in the deployment of attention (“attention hypothesis”) to an unexpected event as firstly suggested by Buccino et al
PMC9870900
Limitations and future directions
Our study has some limitations. Firstly, it is still unclear whether the effects we observed in the current experiment can be extended to situations in which consequences are not merely monetary and much more serious. Intentions in our study are limited to the financial fairness dimension. Our experimental design does ...
PMC9870900
Acknowledgements
This research was supported by Tohoku University Operating Fund President's Discretionary Expenses (Research) (No. 56045090) and Japan Society for the Promotion of Science Grant-in-Aid for Early-Career Scientists (No. 22K15626) (to S.S.), Scientific Research Foundation for the High-level Talents from Fujian University ...
PMC9870900
Author contributions
J.Z.: Conception, data collection, methodology, writing-original draft preparation, S.S.: Writing-original draft preparation, reviewing and editing. C.Z.: Data collection, methodology. Y.C.: Data collection. H.L.: Data collection. Z.Y.: Supervision. R.Y.: Supervision.
PMC9870900