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Patient questionnaire
diabetes-related emotional distress, chronic illness, diabetes
CHRONIC ILLNESS, DIABETES
Sociodemographic data (sex, age, partner status with/without, education ≤8 years/>8 years) and psychological data (see below) were collected via telephone interviews by study team members at the different time points of measurement.The SDM-Q-9 (Shared Decision Making questionnaire; 9 items scored 0–5, total score is th...
PMC10182591
GP questionnaire including treatment goals
non-shared treatment goal).At T2
GPs gave information about their participating patients on a questionnaire (age, sex, measured HbA1c, pharmacotherapy).At T0 GPs indicated once (a) which HbA1c target value they have set together with their patients (shared treatment goal) and (b) if no shared target value has been set, what target value they would lik...
PMC10182591
Statistical methods
T2DM, diabetic distress, diabetes
SECONDARY, RECRUITMENT, SENSITIVITY, DIABETES
Patients with T2DM with an HbA1c ≥ 8.0% (64 mmol/mol) at the time of recruitment and complete data at baseline and T4 were eligible for the presented analyses (see Additional file For a description of the sample, we compared the subgroups of patients with shared HbA1c goal and with non-shared HbA1c goal, using t tests ...
PMC10182591
Results
PMC10182591
Recruitment and participant flow
All patients with an HbA1c value of ≥8.0 at baseline and complete values at T0 and T4 for the primary analyses (decision shared/non-shared, socio-demographics, HbA1c goal, measured HbA1c, insulin vs. no insulin) were included (n = 547; see Additional file 1: flow chart).
PMC10182591
Baseline data
chronic illness, non-shared HbA1c goalHbA1c, diabetes
CHRONIC ILLNESS, DIABETES
GPs state a shared HbA1c goal for n = 287 patients (52.47%) and a non-shared HbA1c goal for n = 260 patients (47.53%). Patients with shared HbA1c goal show slightly lower HbA1c values (both measured and aspired) than patients with non-shared HbA1c goal (see Table  Baseline (T0) characteristics including bivariate compa...
PMC10182591
Longitudinal outcomes
chronic illness, non-shared HbA1c goalHbA1c, diabetes
CHRONIC ILLNESS, DIABETES
After two years (T4), 235 (43%) achieved the HbA1c goal, and 312 (57%) missed the goal. As with baseline HbA1c, patients with a shared HbA1c goal also show slightly lower HbA1c at T4 (see Table  Follow-up characteristics (T4) including bivariate comparisons of the samples shared vs. non-shared HbA1c goalHbA1c glycated ...
PMC10182591
Discussion
PMC10182591
Summary of findings
T2DM
In this study, we investigated whether T2DM patients with a shared versus non-shared HbA1c target, achieved their glycemic goals. In this sample of T2DM patients with poor glycemic control GPs report a mean HbA1c goal of 7.46%. After two years we could not find statistical differences in the level of glycemic goal achi...
PMC10182591
Interpretation in the context of existing literature
T2DM, diabetes
DIABETES
The results of our study showed that a shared goal setting with T2DM patients had no significant impact on glycemic goal achievement. This prompted the question what impact the involvement of the patient in the decision-making process in primary care has on improving patient-relevant outcomes.Kashaf et al. [Lafata et a...
PMC10182591
Strengths and limitations
decline of measured HbA1c levels, diabetes
REGRESSION, DIABETES
One of the key strengths of the DEBATE trial is its long time of follow-up with a total period of 24 months. The follow-up period of previous diabetes management studies was often less than two years [The results of this study should be considered in the context of several important limitations. One is the subjective d...
PMC10182591
Clinical impact and future research
diabetes
POORLY CONTROLLED DIABETES MELLITUS, DISEASE, DIABETES
The results of this study did not show a significant association between shared goal setting, targeting on HbA1c levels and goal achievement.For the patient, the HbA1c value is an abstraction with many implications that are difficult to judge or even understand as a lived experience. A previous study has shown, that po...
PMC10182591
Conclusions
T2DM
SECONDARY
The secondary analyses of the DEBATE trial were not able to show that shared goal setting targeting on HbA1c-levels of patients with poorly controlled T2DM leads to improved goal achievement. Regardless of shared vs. non-shared HbA1c goal, all patients were able to lower their HbA1c-levels.
PMC10182591
Acknowledgements
We thank all patients and general practitioners for their participation in the trial. And we are deeply grateful to all physicians supporting the intervention by peer-visiting GPs.
PMC10182591
Authors’ contributions
MP
AA, SW and HHA designed and managed the project. AW, SS, ED, SL, MP, CH were responsible for setting up the trial, recruiting participants, implementing the intervention, and collecting data. AD and KW supervised data analyses. SS, MP and AW performed data analysis and wrote the manuscript. All authors read and critica...
PMC10182591
Funding
The trial was funded by the German Ministry of Education and Research (Reference: 01GX1041A). The funding body had no influence on the design of the study; collection, analysis, and interpretation of data; and in writing the manuscript.
PMC10182591
Data Availability
The datasets generated and analysed during the current study are available from the corresponding author on reasonable request.
PMC10182591
Declarations
PMC10182591
Ethics approval and consent to participate
MAY
The Ethics Committee at Rostock University Medical Centre approved the DEBATE trial on May 25th, 2011 under the reference A 2011-59. Ethics Committees at the Medical Faculty of the Heinrich-Heine-University Dusseldorf (July 19th, 2011, reference 3676) and at the University of Witten/Herdecke (July 12th, 2011, reference...
PMC10182591
Consent for publication
Not applicable.
PMC10182591
Competing interests
The authors declare no conflict of interest.
PMC10182591
Protocol
DIABETES MELLITUS TYPE 2
Drewelow E, Wollny A, Pentzek M, et al. Improvement of primary health care of patients with poorly regulated diabetes mellitus type 2 using shared decision-making - the DEBATE trial.
PMC10182591
Participating investigators
Sara Santos, Eva Drewelow, Attila Altiner, Christian Helbig, Christin Löffler, Anne Daubmann, Karl Wegscheider, Heinz-Harald Abholz, Susanne Löscher, Michael Pentzek, Stefan Wilm, Anja Wollny.
PMC10182591
Abbreviations
mellitus
General PractitionerDiabetes mellitus type 2Shared Decision-MakingDisease Management Program
PMC10182591
References
PMC10182591
Supplementary Information
borderline personality disorder, BPD
Unstable interpersonal relationships and fear of abandonment are core symptoms of borderline personality disorder (BPD) that often intensify during stress. Psychosocial stress, which includes components of social exclusion and increases cortisol secretion, enhances emotional empathy in healthy individuals. Women with B...
PMC10238344
Keywords
Open Access funding enabled and organized by Projekt DEAL.
PMC10238344
Introduction
borderline personality disorder, HC, BPD
DISORDER
Unstable interpersonal relationships and fear of abandonment are among the defining and most debilitating symptoms of borderline personality disorder (BPD; [Many of the disorder’s core symptoms typically occur in interpersonal contexts [In line with results of other studies showing enhanced prosocial behavior [In anoth...
PMC10238344
Method
PMC10238344
Participants
BPD, DSM-5
SCID, DISORDERS, FRANKLIN
The sample consisted of 98 women with BPD and 98 healthy women, who were matched for age, education, intake of hormonal contraception and menstrual cycle. Women between the ages of 18 and 50 with a BMI between 17.5 and 30 were included. All participants underwent the Structural Clinical Interview for DSM-5 Disorders (S...
PMC10238344
Procedure
Depression
The study involved two testing sessions. In the first session, diagnostic interviews were conducted by trained clinicians. Subsequently patients filled out several German psychopathology questionnaires on a tablet or a computer in the laboratory, including Beck Depression Inventory (BDI-II; [At the second session, part...
PMC10238344
Social exclusion
Participants were randomized to an exclusion or an overinclusion condition of the Cyberball paradigm [Before the game, participants read the instructions, stating that they should imagine the game as if it was happening in real life with real people. It also stated that they would be tossing a ball with two real co-pla...
PMC10238344
Empathy
We assessed cognitive and emotional empathy with a modified version of the Multifaceted Empathy Test (MET; [To assess cognitive empathy, participants were required to infer the mental state of the subject in the photo and to indicate the correct emotion from a list of four. We calculated percentage scores of correct an...
PMC10238344
Physiological outcome variables
FRANKLIN
Saliva samples for analyses of cortisol and salivary alpha-amylase (sAA) were collected using SaliCap devices (IBL, Hamburg, Germany) at the following time points: baseline (0), after Cyberball (+ 20), after MET (+ 35). Until biochemical analyses, performed in the Neurobiology Laboratory of the Department of Psychiatry...
PMC10238344
Statistics
BPD, post-traumatic stress disorder, PTSD, HC
Statistical analyses were performed using SPSS version 27. Demographic variables were analyzed using t-tests for continuous variables and A 2 (overinclusion vs. exclusion) × 2 (BPD vs. HC) ANOVA was carried out for cognitive empathy. Percentage of correct answers served as dependent variable. In a mixed model ANOVA, we...
PMC10238344
Results
PMC10238344
Cyberball—manipulation check
Results on the Need Threat Questionnaire (NTQ) indicate that the Cyberball manipulation was successful. Participants reported higher need threat after exclusion than after overinclusion (main effect condition: Participants reported greater ostracism intensity after exclusion (main effect condition: Overall need threat ...
PMC10238344
Physiological data
PMC10238344
Cortisol
We did not find any group, condition or a group × condition interaction effect on cortisol, all Salivary cortisol (
PMC10238344
Salivary alpha-amylase (sAA)
We did not find any group, condition or a group × condition interaction effect on sAA, all
PMC10238344
Effects of social exclusion on emotional and cognitive empathy
comorbid PTSD, Cognitive empathy, PTSD, BPD
Cognitive empathy scores did not significantly differ between the two Cyberball conditions, (Cognitive empathy (In the analysis of emotional empathy, we found a significant main effect for group, (There was no valence × condition interaction effect (To account for the possible influence of mood on emotional empathy, we...
PMC10238344
Discussion
BPD
We investigated the effects of Cyberball-induced social exclusion on empathy in patients with BPD and healthy controls. Our manipulation was successful, as social exclusion resulted in greater feelings of exclusion compared to the overinclusion condition. Cyberball did not result in an increase in cortisol release. Cog...
PMC10238344
Cognitive empathy
In line with our hypothesis, social exclusion did not change cognitive empathy scores in both groups. This was also found after the TSST [
PMC10238344
Emotional empathy
ambiguous social situations, BPD
Women with BPD showed lower emotional empathy than the control group in response to positive emotional stimuli (e.g., a person showing happiness), but not to negative stimuli. This was also significant after including current mood as a covariate into the analysis. In previous studies, our group did not find reduced emo...
PMC10238344
Cortisol and salivary alpha-amylase
BPD, HC
Women with BPD and HC did not differ in basal cortisol or sAA levels. This matches findings of previous studies that also report no differences between patients with BPD and HC using single rather than continuous measurements of cortisol or sAA [
PMC10238344
Cyberball as a psychosocial stressor
Based on results after psychosocial stress (TSST) [
PMC10238344
Limitations
depression, depressive, BPD
We tested effects of social exclusion in an artificial laboratory setting, which was one of the study’s main limitations. There was a high proportion of patients with comorbid diagnoses and intake of psychotropic medication, however, subgroup analyses yielded no effects on empathy. Patients with depression were exclude...
PMC10238344
Conclusion and outlook
BPD
We conclude that women with BPD do not differ from healthy women in cognitive empathy and that this is not influenced by stress in general and social exclusion in particular. Emotional empathy, on the other hand, seems to be more sensitive to the effects of stress or ambiguous social situations in women with BPD. Speci...
PMC10238344
Supplementary Information
Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 43 KB)
PMC10238344
Funding
Open Access funding enabled and organized by Projekt DEAL. The study was funded by the Deutsche Forschungsgemeinschaft (DFG) (WI 3396/2-3).
PMC10238344
Data availability statement
The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials. Further data are available from the corresponding author (KW) upon reasonable request.
PMC10238344
Declarations
PMC10238344
Conflict of interest
None of the authors have any conflicts of interest.
PMC10238344
Ethics approval
The Charité ethics committee approved the study. The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.
PMC10238344
Patient consent
All participants including patients were informed about the study orally and in written form and had to give written consent before participating. Participants signed informed consent regarding publishing their data.
PMC10238344
References
PMC10238344
Background
ROSC
Checklists are a powerful tool for reduction of mortality and morbidity. Checklists structure complex processes in a reproducible manner, optimize team interaction, and prevent errors related to human factors. Despite wide dissemination of the checklist, effects of checklist use in the prehospital emergency medicine ar...
PMC10655407
Methods
ROSC
CHIPS was a prospective randomized case–control study. Professional emergency medical service teams were asked to perform cardiopulmonary resuscitation on an adult high-fidelity patient simulator achieving ROSC. The intervention group used a checklist which transferred the ERC guideline statements of ROSC into the stru...
PMC10655407
Results
Twenty scenarios in the intervention group (INT) and twenty-one in the control group (CON) were evaluated. The average time of use of the checklist (CU) in the INT was 6.32 min (2.39–9.18 min; SD = 2.08 min). Mean PS of INT was significantly higher than CON, with a strong effect size (
PMC10655407
Conclusion
Checklists can have positive effects on outcome in the prehospital setting by significantly facilitates adherence to guidelines. Checklist use may be time-effective in the prehospital setting. Checklists based on the ‘ABCDE’ mnemonic can be used according to the ‘do verify’ approach. Team Time Outs are recommended to s...
PMC10655407
Keywords
Open Access funding enabled and organized by Projekt DEAL.
PMC10655407
Background
death, hypothermia, ROSC, deaths, trauma
AIDS, COMPLICATION
Human error is a leading cause of death in modern patient care. The estimated number of deaths due to medical errors in registered hospital admissions in the USA is 400,000 deaths/year [Individualized and sufficiently implemented cognitive aids like checklists increase performance when solving time-critical and challen...
PMC10655407
Methods
PMC10655407
Study design/population
EMERGENCY
This was a prospective randomized case–control study (CHIPS, checklist in prehospital settings, German Clinical Trials Register Study ID 00005156). We used the reproducible setting of a full-scale medical simulation. The simulations took place at the Human Simulation Center (HSC) of the University Hospital Munich’s Ins...
PMC10655407
Simulation scenario
ROSC, cardiac arrest
VENTRICULAR FIBRILLATION, CARDIAC ARREST
The scenario took place inside a standard ambulance vehicle (Typ C) mock-up at HSC. Participants were asked to perform cardiopulmonary resuscitation on an adult high-fidelity patient simulator (SimMan 3G, Laerdal Medical AS; Stavanger, Norway). It was reported that he suffered from witnessed cardiac arrest with ventric...
PMC10655407
Checklist
Disability’, ROSC
The checklist used in the scenario transferred the guideline statements of the ERC Consensus 2010 on the management of patients with ROSC into the structure of the well-established, prehospital ‘ABCDE’ mnemonic, which should enable priority-oriented care of emergency. The five sections are organized according to the ‘t...
PMC10655407
Performance score (PS)
GS, ROSC
To allow assessment of guideline adherence, we created the so-called Performance Score (PS) as an evaluation measure. This score evaluates the completeness and prehospital relevance of guideline recommendations for ROSC therapy based on an expert consensus (medical directors of the emergency medical services of the sta...
PMC10655407
Observation time
ROSC
To ensure study continuation on time, an indefinite observation period could not be realized for ROSC therapy section. After the call-out of ROSC, each scenario was continued for 10 min according to protocol. During this time, the patient remained unconscious.To assess time management and effective use of procedure tim...
PMC10655407
Workflow
To assess the degree of organization of the work process, compliance with the defined sequence of actions specified by the checklist was examined. Each item was assigned a fixed place according to the ‘ABCDE’ mnemonic as it was indicated by the checklist. The score is the sum of the deviations from the fixed order divi...
PMC10655407
Data collection/analysis
We captured the following data: (a) continuous A/V recordings of the simulation scenario from different viewing angles and (b) real-time vital sign data from the patient’s monitor using the picture-in-picture technology. The participants also completed a standardized questionnaire with demographic data (before scenario...
PMC10655407
Results
ROSC
Twenty scenarios in the INT and twenty-one in the CON could be evaluated (Fig. Sample Size CHIPS-Study. CHIPS: Checklists in prehospital settingsParticipants (n = 172, 30 women, 122 men, 20 not specified) represented 23 of the 26 emergency service areas at study time. All emergency physicians were board-certified, whil...
PMC10655407
Guideline adherence according to performance score
Coma, seizures, seizure
COMA
The results are displayed in Table Guideline adherence according to performance score39.10 (9.04)18–5931.33 (7.53)13–424.90 (1.83)1–83.29 (2.43)0–79.30 (3.21)3–127.14 (3.07)0–1212.70 (3.92)0–1612.71 (2.83)6–157.80 (4.18)0–156.14 (2.22)3–94.40 (3.68)0–112.05 (3.01)0–8Section A: airway, Section B: breathing, Section C: c...
PMC10655407
Assessment of time management and effective use of treatment time
The average time of use of the checklist (CU) in the INT was 6.32 min (2.39–9.18 min; SD = 2.08 min). No correlation found between CU and PS (In the INT, significantly more items were completed per minute of scenario duration (INT, 1.48 items/min; CON, 1.15 items/min, difference: 0.33/min (29%),
PMC10655407
Assessment of degree of organization of the work process
ROSC
The workflow did not significantly differ between the groups (Workflow as a function of time in a graphical form. X-axis: time in min., Y-axis: ABCDE mnemonic as structure of the checklist, Int: intervention group, Con: control group, star: deviating data valuesA final reassessment, e.g. in the form of a timeout at the...
PMC10655407
Additional findings on checklist use
Three-quarters of the INT teams spontaneously adopted the ‘do verify’ approach to checklist usage, with 15% of the teams using it in the form of a ‘challenge-response’ list. The rest of the teams showed a mixed usage (10%). A relevant proportion in both groups interrupted checklist use and repeatedly continued checklis...
PMC10655407
Discussion
ROSC, trauma
In the prehospital setting, a 25-item checklist for the management of a patient with ROSC can significantly increase guideline adherence and thereby have a direct, potential positive impact on the outcome. This effect was achieved without the need to invest in additional process time. Rather, the checklist significantl...
PMC10655407
Limitation
ROSC
A simulation can only try to reproduce the care practice as best as possible. Yet, a deviation from reality remains, and therefore, certain findings cannot be intuitively ascertained but require an inquiry. The study participants in both groups rated the realism of the scenario design as high. To allow a reproducible s...
PMC10655407
Acknowledgements
The authors would like to personally thank Tobias Imach for sharing our vision, his relentless support during the trainings and his meticulous briefing of the participants of the CHIPS study.
PMC10655407
Author contributions
HT
HD, HT and SI were principal investigators, designed the study, prepared the study data, analyzed the data, prepared the figures, and drafted the manuscript. AZ designed the study, prepared the study data, analyzed the data, interpreted the findings and revised the manuscript.
PMC10655407
Funding
Open Access funding enabled and organized by Projekt DEAL. There was no funding for this study. No further money was taken externally from any institution or company.
PMC10655407
Availability of data and materials
Please contact author for data requests.
PMC10655407
Declarations
PMC10655407
Ethics approval and consent to participate
The study was performed in accordance with the Declaration of Helsinki and approved by the ethics committee of the Faculty of Medicine of the Ludwig-Maximilians-Universität in Munich (ID 475-12) and the University of Witten/Herdecke, Germany approved the study (ID 12/2020).
PMC10655407
Consent for publication
Not applicable.
PMC10655407
Competing interests
The authors declare that they have no competing interests.
PMC10655407
References
PMC10655407
Introduction
inflammation, nerve injury, arthritis, pain
INFLAMMATION, ARTHRITIS
[version 1; peer review: 2 approved] The aim of this study was to determine the clinical effectiveness and safety profile of PeaNoc XL in patients with arthritis experiencing joint pain and inflammation. Alternative medicine, encompassing herbal medicines, phytonutrients, ayurvedic products, and nutraceuticals, is...
PMC10521040
Objectives
adverse drug reactions, arthritis, pain
INFLAMMATION, ADVERSE DRUG REACTIONS, ARTHRITIS
To evaluate the efficacy of PeaNoc XL tablets on biochemical parameters in arthritis patients with joint pain and inflammation.To evaluate the efficacy of PeaNoc XL tablets on inflammatory cytokines in arthritis patients with joint pain and inflammation.To assess the efficacy and safety of PeaNoc XL tablets in relatio...
PMC10521040
Methods
PMC10521040
Study design
A randomized, controlled, open-labelled trial was conducted at a SRM Medical College Hospital and Research Centre in Tamil Nadu.
PMC10521040
Ethical considerations
The study adhered to the guidelines set forth by the International Committee on Harmonization on Good Clinical Practice and followed the revised version of the Declaration of Helsinki. Approval for the study protocol was obtained from the institutional human ethics committee of SRM Medical College Hospital and Research...
PMC10521040
Investigational product
PeaNoc XL Tablet contains astaxanthin (1mg) + palmitoylethanolamide (400mg)Direction: two tablets once daily (OD)
PMC10521040
Inclusion criteria
arthritis
DISEASE, ARTHRITIS
Eligible participants diagnosed with arthritis, regardless of sex, in the age range of 18 to 60 years (inclusive).Patients with a DAS 28 (Disease Activity Score) score greater than or equal to 3.2Voluntary willingness to provide written informed consent for participation.Ability to comprehend the nature and objectives...
PMC10521040
Exclusion criteria
diabetic neuropathyPatients, psychiatric, hypersensitivity
HYPERSENSITIVITY
Participants taking other non-steroidal anti-inflammatory drugs (NSAIDs)/painkillers other than standard drugAbnormal results on liver function testPatients with diabetic neuropathyPatients with severe renal, hepatic, cardiac, gastrointestinal, neurological, hematological, or respiratory disorderPatients with a psychi...
PMC10521040
Treatment groups
GROUP B
In this pilot study conducted over a duration of nine months, a sample size of 30 patients was divided into two groups. Group A received standard therapy for the specified condition, while Group B received standard therapy in addition to PeaNoc XL Tablet 400mg, taken orally after food.Group A: Standard therapyGroup B: ...
PMC10521040
Study procedure
Arthritis
ARTHRITIS, GROUP B
The included study populations based on study criteria were randomized into two groups by using a computer-generated random sequence in R software. Group A received Standard therapy and Group B received Standard therapy with PeaNoc XL Tablet 400mg (two tablets OD after food).The hematology, liver, and kidney functions ...
PMC10521040
Biochemical assessment
TNF-α
-20
Morning blood samples of 5mL were collected via venous puncture from participants who had fasted overnight, specifically between the hours of 8:00 a.m. and 10:00 a.m. Following collection, centrifugation was performed using an Eppendorf Centrifuge 5430R. The resulting samples were divided into aliquots and stored at -2...
PMC10521040
WOMAC questionnaire
Pain, OA, knee osteoarthritis, pain
BENDING, KNEE OSTEOARTHRITIS, -20
The WOMAC pain scale is extensively used in the evaluation of hip and knee osteoarthritis (OA). It is a self-managed questionnaire consisting of 24 items divided into three subscales, as follows: Pain (five items): while walking, using stairs, in bed or rest, sitting or lying, and standing uprightStiffness (two items):...
PMC10521040
Results
GROUP B
A total number of 155 patients were assessed for admissibility, while 83 patients were excluded. In the end, 72 patients were included and were randomized into two groups. Group A received Standard therapy and Group B received standard therapy with PeaNoc XL (
PMC10521040
Flow diagram following CONSORT guidelines.
PMC10521040