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Use of intervention sessions and relation to proportion of days abstinent
The number of app sessions completed in the app-based mindfulness training group was significantly less than controls (15.6 vs 19.9 app sessions completed, Relation between the number of intervention sessions completed before the quit date and abstinence days during the quit period, by group. App-based mindfulness trai...
PMC10715839
Discussion
tobacco-related diseases, smoking reduction, Cancer
RECRUITMENT, CANCER
In this registered randomized controlled study, structured by a 2-week intervention period preceding a voluntary planned smoking quit date, we tested the effect of an app-based mindfulness training intervention compared with an attention control on smoking behavior during a 28-day quit attempt period. The trial results...
PMC10715839
Supplementary Material
Click here for additional data file.
PMC10715839
Acknowledgements
Headspace, Inc, generously provided free access codes for use of the Headspace app in the study but had no influence on the study implementation or interpretation of results in any way. We used the citation database resource provided by the American Mindfulness Research Association for our literature review (
PMC10715839
Data availability
Data are provided in an online supplement accompanying this article, as published by the Journal.
PMC10715839
Author contributions
David Black, PhD (Conceptualization; Funding acquisition; Investigation; Methodology; Project administration; Supervision; Writing—original draft; Writing—review & editing), Matthew Kirkpatrick, PhD (Conceptualization; Funding acquisition; Investigation; Methodology; Project administration; Supervision; Writing—review ...
PMC10715839
Funding
DISEASE
Funding support was provided by a grant from the Tobacco-Related Disease Research Program (No. T29IR0452 to M.K.) and a grant from the MGM Foundation for innovation in smoking cessation research to D.B.
PMC10715839
Conflicts of interest
All authors declare that there are no conflicts of interest.
PMC10715839
References
PMC10715839
Introduction
hyperglycemia, stroke, T2D, diabetic macrovascular complications
STROKE, DYSFUNCTION, HYPERGLYCEMIA, INSULIN RESISTANCE, EVENTS, TYPE 2 DIABETES
The frequency of type 2 diabetes (T2D) in older ages has been reported to be increasing annually in Japan. According to a recent report from the Japan Ministry of Health, Labor and WelfareIn terms of diabetic macrovascular complications, a Japanese randomized trial, J-EDIT, which was designed to evaluate the benefits o...
PMC9813363
Methods
PMC9813363
Study design
This study was designed as a multicenter, open-label, randomized controlled trial. This trial has been registered at the University Hospital Medical Information Network (UMIN) as the
PMC9813363
Participants
T2D
TYPE 1 DIABETES, CHRONIC RENAL FAILURE
Eligible patients were T2D outpatients with ordinary physical activity, aged 65–80 years with HbA1c levels of 7.4–10.4% (the percentage value of the National Glycohemoglobin Standardization Program) who were under non-pharmacological (diet and exercise) or pharmacological treatment with oral anti-diabetic drugs, and wh...
PMC9813363
Outcomes
retinopathy, nephropathy
RETINOPATHY, ADVERSE EVENTS, HYPOGLYCEMIA, SECONDARY, NEPHROPATHY, PERIPHERAL NEUROPATHY
The primary efficacy outcomes were changes in glycemic parameters, including fasting plasma glucose (FPG), HbA1c, and glycated albumin (GA) levels, and the secondary outcomes were changes in body weight, body mass index (BMI), and insulin-related parameters (fasting insulin and proinsulin). Potential improvements (or s...
PMC9813363
Measurements
hypoglycemia, retinopathy, TG, pre-proliferative retinopathy
RETINOPATHY, ADVERSE EVENTS, HYPOGLYCEMIA, BLOOD, PROLIFERATIVE RETINOPATHY
Venous blood and urine samples were collected under fasting conditions at baseline and at 3, 6, and 12 months of treatment and were transferred to the central laboratory (SRL Inc., Tokyo, Japan). Body weight and blood pressure were measured at baseline and at every follow-up visit. Episodes of hypoglycemia or adverse e...
PMC9813363
Safety analysis
ADVERSE EVENTS, ADVERSE EFFECTS, ADVERSE EFFECT, DISEASES
Clinical adverse events were recorded from participants’ medical records. All newly reported symptoms and diseases during the treatment period were defined as clinical adverse events. Adverse effects in laboratory measurements were defined in accordance with the Common Terminology Criteria for Adverse Effects (CTCAE) v...
PMC9813363
Sample size and statistical analysis
T2D
Based on our previous study in T2D patients treated with sitagliptin
PMC9813363
Results
PMC9813363
Patient characteristics
Comorbidity
A total of 176 patients were enrolled and randomly allocated into sitagliptin (n = 88) and control groups (n = 88). Males numbered 47 (57.3%) and 45 (59.2%) in sitagliptin and control group, respectively (P = 0.87). Of the participants, 18 were excluded from the efficacy analysis because of protocol violation (n = 7), ...
PMC9813363
Efficacy analysis
SECONDARY, INTERACTION
The month-specific changes in glycemic parameters of primary outcomes are shown in Fig. Treatment effect of sitagliptin on glycemic parameters. Changes in fasting plasma glucose (FPG, mg/dL) (Average changes in parameters of primary and secondary outcomes during treatment based on a mixed-effects model analysis.*‘Diffe...
PMC9813363
Safety analysis
ADVERSE EVENTS, ADVERSE EFFECTS, ADVERSE EVENT
Safety analyses were performed in 84 and 74 patients in sitagliptin and control groups, respectively (Fig. Clinical adverse effects during treatment.Adverse events were analyzed in all patients according to the actual use of sitagliptin. Clinical adverse events were assessed in 84 patients treated with sitagliptin and ...
PMC9813363
Discussion
T2D, thrombocytopenia, hypoglycemia, hyperglycemia, hypoglycemia unawareness, albuminuria
HYPOGLYCEMIA UNAWARENESS, ADVERSE EVENTS, THROMBOCYTOPENIA, NOCTURNAL HYPOGLYCEMIA, ADVERSE EFFECT, DISORDERS, HYPOGLYCEMIA, ADVERSE EFFECTS, HYPERGLYCEMIA, SYNDROMES
Here, we present the results of the STREAM study, a new randomized controlled trial that demonstrated the efficacy and safety of sitagliptin treatment in older T2D patients with moderate glycemic control. Improvements in the glycemic parameters were significantly greater in sitagliptin group than control group. In addi...
PMC9813363
Supplementary Information
The online version contains supplementary material available at 10.1038/s41598-022-27301-9.
PMC9813363
Acknowledgements
K. Tateoka, Diabetes
HEART, CROSS, DIABETES
We thank all of the members of the STREAM study group; T. Asano (Nishimura Memorial Hospital, Tokyo), S. Aoyama (Oomura Hospital, Tokyo), T. Fukushima (Mitaka Health Care Clinic, Tokyo), J. Yan (Kyowa Clinic. Tokyo), O. Hasegawa (Heisei Tateishi Hospital, Tokyo), K. Hosokawa (Hosokawa Internal Medicine Clinic, Tokyo), ...
PMC9813363
Author contributions
All authors contributed significantly to this work. M.N. and S.O. conceived of and designed the study. M.N., K.T.I., T.H., and S.O. collected the data and performed the analyses. J.S. and I.S. helped to shape the research. M.N. and S.O. wrote the paper, and H.S. and I.S. critically reviewed the paper.
PMC9813363
Funding
KIDNEY
This study was financially supported by the Kidney Foundation (Tokyo, Japan).
PMC9813363
Data availability
All data generated or analyzed during this study are included in this published article.
PMC9813363
Competing interests
The authors declare no competing interests.
PMC9813363
References
PMC9813363
Key Points
PMC10193186
Question
trauma
Can deliberate practice (goal-oriented training with a coach who provides immediate, personalized performance feedback) improve diagnostic reasoning in trauma triage?
PMC10193186
Findings
In this pilot randomized clinical trial of a novel deliberate practice intervention, 93% of participants received 3 planned coaching sessions, and most participants (93%) described the sessions as entertaining and valuable. During a simulation, the triage decisions of physicians in the intervention group were more like...
PMC10193186
Meaning
The deliberate practice intervention was feasible, acceptable, and effective in the laboratory, setting the stage for a future phase 3 clinical trial.
PMC10193186
Importance
nontrauma
Diagnostic errors made during triage at nontrauma centers contribute to preventable morbidity and mortality after injury.
PMC10193186
Objective
trauma
To test the feasibility, acceptability, and preliminary effect of a novel deliberate practice intervention to improve diagnostic reasoning in trauma triage.
PMC10193186
Design, Setting, and Participants
This pilot randomized clinical trial was conducted online in a national convenience sample of 72 emergency physicians between January 1 and March 31, 2022, without follow-up.
PMC10193186
Interventions
Participants were randomly assigned to receive either usual care (ie, passive control) or a deliberate practice intervention, consisting of 3 weekly, 30-minute, video-conferenced sessions during which physicians played a customized, theory-based video game while being observed by content experts (coaches) who provided ...
PMC10193186
Main Outcomes and Measures
REGRESSION
Using the Proctor framework of outcomes for implementation research, the feasibility, fidelity, acceptability, adoption, and appropriateness of the intervention was assessed by reviewing videos of the coaching sessions and conducting debriefing interviews with participants. A validated online simulation was used to ass...
PMC10193186
Results
The study enrolled 72 physicians (mean [SD] age, 43.3 [9.4] years; 44 men [61%]) but limited registration of physicians in the intervention group to 30 because of the availability of the coaches. Physicians worked in 20 states; 62 (86%) were board certified in emergency medicine. The intervention was delivered with hig...
PMC10193186
Conclusions and Relevance
trauma
In this pilot randomized clinical trial, coaching was feasible and acceptable and had a large effect on simulated trauma triage decisions, setting the stage for a phase 3 trial.
PMC10193186
Trial Registration
trauma
ClinicalTrials.gov Identifier: This pilot randomized clinical trial conducted among emergency physicians tests the feasibility, acceptability, and preliminary effect of a novel deliberate practice intervention to improve diagnostic reasoning in trauma triage.
PMC10193186
Introduction
nontrauma, injuries, trauma
Half of all injured patients present initially to a nontrauma center, where a clinician must evaluate and stabilize the patient’s injuries and determine whether they warrant transfer to a trauma center.Deliberate practice, defined as goal-oriented training in the presence of a content expert who can provide personalize...
PMC10193186
Methods
PMC10193186
Study Overview
trauma
We conducted a pilot randomized clinical trial of a deliberate practice intervention to improve diagnostic reasoning in trauma triage between January 1 and March 31, 2022, without follow-up. We enrolled and randomized a national respondent-driven sample of physicians to the intervention group or to a passive control gr...
PMC10193186
Trial Participants and Coaches
nontrauma, trauma
To recruit participants for the study, we contacted physicians who had previously participated in our research and asked them to refer us to 2 colleagues. We sought board-certified emergency physicians who treated adult patients in the emergency department of either a nontrauma center or a Level III or IV trauma center...
PMC10193186
Interventions
PMC10193186
Deliberate Practice
trauma
The intervention consisted of 3 weekly, 30-minute, video-conferenced coaching sessions, in which the participant played a trauma triage video game, the coach observed his or her performance, and they discussed best practice decision principles in trauma triage. We describe the conceptual framework of the intervention i...
PMC10193186
Conceptual Framework of Intervention
PMC10193186
Video Game
trauma
We used a single-player, theory-based puzzle video game, previously developed by our group to improve diagnostic reasoning in trauma triage (
PMC10193186
Coaching
Both the participant and the coach logged into Zoom, and the participant shared his or her screen so that the coach could observe gameplay. The coach would select the levels covered during the session, personalizing the selection to the needs and skills of the participant. The coach would also encourage the participant...
PMC10193186
Passive Control
We did not ask trial participants randomly assigned to the control group to engage in any additional continuing medical education, with the intention of replicating usual care.
PMC10193186
Trial Protocol
After randomization, participating physicians received written instructions on how to complete the trial tasks. We had the capacity to provide coaching for 30 physicians. We therefore asked those in the intervention group to select 1 of the 2 blocks (January or February) in which we offered coaching and to sign up for ...
PMC10193186
Outcomes
Using the Proctor framework of outcomes for implementation research, we assessed both implementation and service outcomes.
PMC10193186
Data Sources and Management
PMC10193186
Screening Questionnaire and Tracking Database
Each respondent described his or her personal characteristics on the screening questionnaire at the time of enrollment. We maintained a database with a list of scheduled coaching sessions, which was updated daily with the status of the sessions.
PMC10193186
Coaching Sessions
We recorded all the coaching sessions and automatically uploaded them to a secure server hosted by the University of Pittsburgh. Two members of the study team (K.R. and J.L.B.) developed a codebook to assess the delivery of session tasks, refined it until they achieved acceptable interrater reliability (Cohen κ = 0.84)...
PMC10193186
Postintervention Debriefing Materials
Participants in the intervention group provided structured assessments of the acceptability of the intervention using the User Engagement Scale–Short Form to evaluate the video game (a validated 12-item instrument with a 5-point Likert scale) and the Wisconsin Surgical Coaching Rubric to evaluate the quality of the coa...
PMC10193186
Simulation to Measure Efficacy
We used a validated 2-dimensional simulation to assess compliance with guidelines after exposure to the intervention.
PMC10193186
Statistical Analysis
We summarized physician characteristics using mean (SD) values for continuous variables and counts and percentages for categorical variables. We analyzed implementation outcomes using an intention-to-treat approach but excluded from the efficacy analysis participants who did not use the simulation. We had 2 criteria fo...
PMC10193186
Implementation Outcomes
We quantified the percentage of coach-participant dyads that completed three 30-minute sessions (to measure feasibility) and summarized the percentage of session tasks delivered to participants (to measure fidelity). We summarized participant responses to the User Engagement Scale–Short Form and to the Wisconsin Surgic...
PMC10193186
Efficacy
trauma
REGRESSION
We summarized the time spent and the decisions made for each severely injured trauma case (n = 4) on the simulation (eg, diagnostic testing or administration of blood products) using median values and IQRs, and we scored disposition decisions as consistent with the American College of Surgeons guidelines or not. To com...
PMC10193186
Human Participants and Power Calculation
We designed the experiment to detect a 25% (large effect size) reduction in undertriage between physicians in the intervention and control groups, with an α of .05 and a power of 80%, using the Cohen method of estimating power for behavioral trials. Based on these estimates, and anticipating a 67% retention rate in the...
PMC10193186
Results
PMC10193186
Participant Characteristics
We randomly assigned 72 physicians to the 2 groups of the trial but limited registration of physicians in the intervention group to 30 because of the availability of the coaches (
PMC10193186
Participant Characteristics
Trauma
Abbreviation: ATLS, Advanced Trauma Life Support.Of the 36 physicians in the control group, 21 (58%) finished the virtual simulation. The characteristics of the responders and nonresponders are listed in eTable 1 in
PMC10193186
Feasibility and Fidelity
We summarize our assessment of the intervention in
PMC10193186
Summary of Assessment of Intervention Using the Proctor Framework of Outcomes in Implementation Research
A prespecified criterion for the success of the trial was to have 90% or more of dyads complete all 3 training sessions.A prespecified criterion for the success of the trial was to have a 25% reduction in undertriage.This represents the difference in compliance between the 2 groups: 50 of 99 for the intervention group ...
PMC10193186
Acceptability, Appropriateness, and Adoption
SAID
In semistructured interviews, most participants (93% [26 of 28]) in the intervention group described the sessions as entertaining, providing a useful refresher of guidelines, distilling clear learning points, and modeling valuable communication scripts for emergency department physicians. Most participants responded th...
PMC10193186
Participant Assessments of the Acceptability, Appropriateness, and Adoption of the Intervention During Semistructured Interviews
PMC10193186
Acceptability
PMC10193186
Theme: intervention valuable (26 of 28 [93%])
traumas, trauma
Subtopic: entertaining and fun “I mean I personally liked it a lot, so I was actually looking forward to doing the next session. The cases were fun to do and still at the end the review allowed you to sort of put it together, and get better at it actually, for the next time.”“I’d never done anything like that before in...
PMC10193186
Theme: intervention not valuable (7 of 28 [25%])
Subtopic: does not reflect realities of clinical practice “You’re asking me to transfer a patient out based on let’s say their age or injury, and you know a lot of the times the surgeon in house, if I’m working in a small hospital, I only know what they can handle and cannot handle, and it’s not totally up to me to tra...
PMC10193186
Appropriateness
PMC10193186
Theme: time burden (20 of 28 [71%])
SAID
Subtopic: participants responded that the length and number of sessions were appropriate (16 of 20 [80%]) “They were great, [coach] was wonderful, the game was fun. They were just the right amount of length, you know what I mean we did like a I think a half an hour 3 times it was like, we got to play like 1 or 2 games ...
PMC10193186
Theme: would recommend (23 of 28 [82%])
trauma
Subtopic: unreservedly (20 of 23 [87%]) “I didn’t know what this was going to be frankly…when I signed up; but I was pleasantly surprised. I think it was very engaging. I almost would, you know if this was available, I would probably use it for my own doctors at my department. I think people would find it very useful. ...
PMC10193186
Adoption
PMC10193186
Theme: adoption (25 of 28 [89%])
trauma
MINOR, SAID
Subtopic: have already done so (6 of 25 [24%]) “Yeah, so I work with residents. So, although it was useful to me, you know, every time like I do something and like something I just learned comes up I kind of pass it on to somebody else. They’re like, ‘Oh why are we thinking about transferring him,’ ‘Oh it’s because he’...
PMC10193186
Efficacy
trauma
Physicians in the intervention group spent a median of 5.3 minutes (IQR, 3.6-7.7 minutes) on severely injured cases and entered a median of 10 orders per case (IQR, 8-13 orders per case), while those in the control group spent a median of 6.8 minutes (IQR, 4.8-9.2 minutes) and entered a median of 11 orders per case (IQ...
PMC10193186
Discussion
trauma, nontrauma, ’
In this pilot randomized clinical trial, we delivered a novel deliberate practice intervention to practicing emergency medicine physicians with high fidelity. Most physicians described the intervention as valuable and the time required as appropriate. They also reported intentions to adopt the lessons learned during th...
PMC10193186
Limitations
ATTRITION
This study has several limitations. First, we used a passive rather than an active control as the comparator, which may have magnified the effect of the intervention. Second, attrition in the completion of the virtual simulation differed among the control and intervention groups, which we attribute to engagement. Attri...
PMC10193186
Conclusions
This successful pilot randomized clinical trial sets the stage for a planned phase 3 trial of our novel behavioral intervention. The trial also provides evidence that deliberate practice can support judgment tasks, as well as the procedural tasks addressed in most applications, and therefore extends the utility of the ...
PMC10193186
Abstract
PMC10134272
Background
GASTRIC CANCER
In this randomized phase II study, we evaluated the efficacy and safety of sorafenib in combination with capecitabine and cisplatin (XP) as first‐line chemotherapy in advanced gastric cancer.
PMC10134272
Patients and Methods
DISEASE PROGRESSION, SECONDARY, GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA
Patients with metastatic gastric or gastroesophageal junction adenocarcinoma were randomized (1:1) to receive either sorafenib plus XP (S + XP) or XP alone. In cases of disease progression in the XP arm, crossover to sorafenib alone was allowed. The primary endpoint was progression‐free survival (PFS). The secondary en...
PMC10134272
Results
Between Jan 2011 and Feb 2013, a total of 195 patients were accrued (97 in the S + XP arm and 98 in the XP alone arm). The overall response rate was 54% with S + XP, and 52% with XP alone (
PMC10134272
Conclusion
METASTATIC GASTRIC CANCER, GASTRIC CANCER
The addition of sorafenib to XP chemotherapy was safe but not more effective than XP alone for first‐line treatment of metastatic gastric cancer.In this randomized phase II study, we evaluated the efficacy and safety of sorafenib in combination with capecitabine and cisplatin (XP) as first‐line chemotherapy in advanced...
PMC10134272
INTRODUCTION
Gastric cancer, multiple cancer, anti‐angiogenesis, cancer, deaths
GASTRIC CANCER, CANCER, MULTIPLE CANCER, METASTASIS
Gastric cancer (GC) is the fifth most common type of cancer and represents the fourth leading cause of cancer‐related deaths worldwide.Although there is no single standard cytotoxic chemotherapy regimen for metastatic or unresectable GC, fluoropyrimidine and platinum‐containing doublet or triplet regimens are the stand...
PMC10134272
METHODS AND MATERIALS
PMC10134272
Study design and patients
bleeding, embolic events, hematologic, hepatic, and renal function, thrombotic
BRAIN METASTASIS, BLEEDING, RECURRENCE, GASTROINTESTINAL BLEEDING, MAY, SOLID TUMOR, ADENOCARCINOMA, ONCOLOGY
This was an open‐label, multicenter, randomized phase II study comparing XP with or without sorafenib in chemotherapy‐naive patients with metastatic GC. Patients were enrolled from 12 centers in Korea, China, and Taiwan.Patients with histologically proven metastatic gastric or gastroesophageal junction adenocarcinoma w...
PMC10134272
Study treatment
DISEASE
Eligible patients were randomly assigned (1:1) to the experimental S + XP arm or control XP arm. Randomization was conducted via a computer‐generated random‐block permutation method with stratification factors including countries (Korea vs. China vs. Taiwan), disease status (initially metastatic vs. recurrent), and pri...
PMC10134272
Assessment
Toxicities, chest X‐ray, Tumor, Cancer
ADVERSE EVENT, ADVERSE EVENT, TUMOR, CANCER
Baseline assessments included medical history, physical examination, laboratory tests, chest X‐ray, and an abdominal and pelvic CT scan with contrast enhancement. Toxicities were assessed every cycle. For response assessment, CT scans with chest X‐ray were performed every 6 weeks up to week 54, and then every 12 weeks....
PMC10134272
Biomarkers analysis
As candidate tissue biomarker analyses, immunohistochemistry (IHC) for pERK (Cell Signaling, #4376, dilution 1:200), VEGF (BD Pharmingen, #555036, dilution 1:3200), neuropilin (Santa Cruz, sc‐5307, dilution 1:50), PDGFβ (Bioworld, BS1290, dilution 1:400), and HER2 (Roche Diagnostics, clone 4B5) were performed on 5 μm s...
PMC10134272
Statistical analysis
death
DISEASE PROGRESSION
The primary endpoint of this study was PFS by the independent central review. Secondary endpoints included OS, response rates, safety profiles, biomarkers, and response rates and PFS with second‐line sorafenib alone after progression in the XP arm. This trial was designed to detect an improvement in PFS when sorafenib ...
PMC10134272
RESULTS
ONCOLOGY
Between January 2011 and February 2013, 195 patients were randomly allocated to the S + XP arm (Baseline patient characteristics.Abbreviations: ECOG, Eastern Cooperative Oncology Group; S, sorafenib; XP, capecitabine and cisplatin.The trial database was locked in November 2013 for the final analysis, according to prede...
PMC10134272
Efficacy
DISEASE
With a median follow‐up duration of 12.6 months (range, 0.1–29.2), the median PFS by the independent central review, the primary endpoint of this study, was 5.6 months (95% CI, 4.4–6.8) with S + XP and 5.3 months (95% CI, 4.2–5.7) with XP alone (HR 0.92, 95% CI 0.67–1.27; Figure Progression‐free survival according to t...
PMC10134272
Safety profile
toxicities
ADVERSE EVENTS, ADVERSE EVENT
A median 6 cycles of chemotherapy were given for both groups. Study treatment was discontinued due to toxicities in 10% and 3% of patients in the S + XP and XP arms, respectively. Doses of capecitabine and cisplatin were reduced due to the toxicities in 63% and 57%, respectively, in the S + XP arm, and 68% and 68%, res...
PMC10134272
Predictive biomarkers
tumor
TUMOR
In each subgroup categorized by the baseline biomarker levels, PFS was compared between S + XP and XP alone (Figure Predictive biomarker analysis with tumor tissues and circulating soluble proteins. In each subgroup categorized by the baseline biomarker levels, PFS was compared between S + XP and XP alone. In cases of ...
PMC10134272
DISCUSSION
tumor
TUMOR, HEPATOCELLULAR CARCINOMA
This multinational, multicenter, randomized phase II study showed that the addition of sorafenib to XP did not improve the response rates, PFS or OS, although the doses for this combination established in a previous phase I study were well tolerated. Moreover, only limited activity of sorafenib monotherapy in a second‐...
PMC10134272
AUTHOR CONTRIBUTIONS
PMC10134272
FUNDING INFORMATION
This study was supported in part by Bayer Pharmaceutical Co., Ltd.
PMC10134272