German Clinical Trials Register Research Articles

A web-based knowledge database to provide evidence-based information to cancer patients: Utilization within the PIKKO study

PurposeCancer is associated with an urgent need for understandable and reliable information, which is often not satisfied by information available online. Therefore, as part of the PIKKO project, a web-based knowledge database (WDB) was introduced to provide cancer patients with quality-assured, evidence-based information. This paper aims to provide insights into the usage (Who? How? What?) and the effects regarding health literacy of the WDB.MethodsA patient survey and automatically generated logfile data were evaluated. Two user groups, patients and patient navigators (PNs), were compared.ResultsThe 13 PNs were responsible for 1/3 of all accesses over the entire duration of the project. The 413 patients used WDB twice on average and spent an average of 12 min per session online (PNs: 9 min per session, more frequently). The top 3 topics of interest were ‘therapy’, ‘nutrition’ and ‘carcinogenesis’ for the patients, and ‘therapy’, ‘naturopathy’ and ‘legal regulations/support’ for the PNs. Of the patients surveyed, 69% said that WDB was helpful in making informed decisions, 76% found the information they wanted and 90% thought WDB was an appropriate way to provide information.ConclusionOur WDB provided important information about cancer and its treatment on a digital way both, to patients and PNs. In routine cancer care, the WDB can improve health literacy and informed decision-making.Trial registrationThis study was retrospectively registered in the German Clinical Trial Register under DRKS00016703 (21 Feb 2019, retrospectively registered). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016703

Roger’s diffusion of innovations theory and the adoption of a patient portal’s digital anamnesis collection tool: study protocol for the MAiBest project

BackgroundGerman hospitals are legally obliged to implement digital patient portals within the next years. Systematic reviews show that the use of patient portals may be associated with improved patient-centeredness and workflows. However, mandatory digital healthcare innovations are sometimes not used by the target group as planned or even completely rejected. Based on Roger's theory of innovation diffusion, it can be assumed that the time factor is of particular importance for the adoption of the patient portal. The aim of the project is to assess determinants of patient portal adoption and to examine whether Roger’s theory can be confirmed.MethodsThe project investigates the use of the patient portal in three different clinics of a large academic teaching hospital in Germany using a longitudinal study design with three cross-sectional time points (pre, post, post). Doctors and patients are surveyed about factors that predict the use of the patient portal and whether the strength of these factors changes over time. They are also interviewed about possible barriers they experience when using the patient portal or about the reasons why the patient portal is not used. Regression models and content analyses are used to answer the research questions.DiscussionDeterminants of patient portal use will be discussed under the light of the temporal component of Roger's theory. At the same time, it is expected that some determinants will remain unchanged over time. Identifying determinants independent of time allows targeting the groups, enabling specific communication strategies to empower these groups to use the patient portal, contributing to an equal health care system.Trial registrationThe study was prospectively registered in the German register of clinical trials (DRKS00033125) in May 2024.

Inter-joint coordination with and without dopaminergic medication in Parkinson’s disease: a case-control study

BackgroundHow the joints exactly move and interact and how this reflects PD-related gait abnormalities and the response to dopaminergic treatment is poorly understood. A detailed understanding of these kinematics can inform clinical management and treatment decisions. The aim of the study was to investigate the influence of different gait speeds and medication on/off conditions on inter-joint coordination, as well as kinematic differences throughout the whole gait cycle in well characterized pwPD.Methods29 controls and 29 PD patients during medication on, 8 of them also during medication off walked a straight walking path in slow, preferred and fast walking speeds. Gait data was collected using optical motion capture system. Kinematics of the hip and knee and coordinated hip-knee kinematics were evaluated using Statistical Parametric Mapping (SPM) and cyclograms (angle-angle plots). Values derived from cyclograms were compared using repeated-measures ANOVA for within group, and ttest for between group comparisons.ResultsPD gait differed from controls mainly by lower knee range of motion (ROM). Adaptation to gait speed in PD was mainly achieved by increasing hip ROM. Regularity of gait was worse in PD but only during preferred speed. The ratios of different speed cyclograms were smaller in the PD groups. SPM analyses revealed that PD participants had smaller hip and knee angles during the swing phase, and PD participants reached peak hip flexion later than controls. Withdrawal of medication showed an exacerbation of only a few parameters.ConclusionsOur findings demonstrate the potential of granular kinematic analyses, including > 1 joint, for disease and treatment monitoring in PD. Our approach can be extended to further mobility-limiting conditions and other joint combinations.Trial registrationThe study is registered in the German Clinical Trials Register (DRKS00022998, registered on 04 Sep 2020).

The Effectiveness of Dialectical Behavior Therapy Compared to Schema Therapy for Borderline Personality Disorder: A Randomized Clinical Trial

Introduction: In the treatment of borderline personality disorder (BPD), there is empirical support for both dialectical behavior therapy (DBT) and schema therapy (ST); these treatments have never been compared directly. This study examines whether either of them is more effective than the other in treating patients with BPD. Methods: In this randomized, parallel-group, rater-blind clinical trial, outpatients aged between 18 and 65 years with a primary diagnosis of BPD were recruited in a tertiary outpatient treatment center (Lübeck, Germany). Participants were randomized to DBT or ST with one individual and one group session per week over 1.5 years. The primary outcome was the BPD symptom severity assessed with the mean score of the Borderline Personality Disorder Severity Index at 1-year naturalistic follow-up. Results: Between November 26, 2014, and December 14, 2018, we enrolled 164 patients (mean age = 33.7 [SD = 10.61] years). Of these, 81 (49.4%) were treated with ST and 83 (50.6%) with DBT, overall, 130 (79.3%) were female. Intention-to-treat analysis with generalized linear mixed models did not show a significant difference at 1-year naturalistic follow-up between DBT and ST for the BPDSI total score (mean difference 3.32 [95% CI: –0.58–7.22], p = 0.094, d = −24 [–0.69; 0.20]) with lower scores for DBT. Pre-to-follow-up effect sizes were large in both groups (DBT: d = 2.45 [1.88–3.02], ST: d = 1.78 [1.26–2.29]). Conclusion: Patients in both treatment groups showed substantial improvements indicating that even severely affected patients with BPD and various comorbid disorders can be treated successfully with DBT and ST. An additional non-inferiority trial is needed to show if both treatments are equally effective. The trial was retrospectively registered on the German Clinical Trials Register, DRKS00011534 without protocol changes.

Combining app-based behavioral therapy with electronic cigarettes for smoking cessation: a study protocol for a single-arm mixed-methods pilot trial

BackgroundCigarette smoking remains a leading cause of preventable illness and death, underscoring the need for effective evidence-based smoking cessation interventions. Nuumi, a novel smoking cessation program integrating a digital behavioral therapy and an electronic cigarette, may provide a solution.ObjectiveTo investigate the initial efficacy, acceptability and psychological outcomes of an evidence-based smoking cessation intervention comprised of a mobile phone app and an electronic cigarette among adults who smoke and who are motivated to quit.MethodsA prospective 6-month single-arm mixed-methods pilot study will be conducted. Seventy adults who smoke and who are motivated to quit will be recruited via web-based advertisements and flyers. Participants receive access to an app and an electronic cigarette with pods containing nicotine for temporary use of at least 3 months. The electronic cigarette is coupled with the app via Bluetooth, allowing for tracking of patterns of use. The behavioral therapy leverages evidence-based content informed by cognitive behavioral therapy and mindfulness-informed principles. Web-based self-report surveys will be conducted at baseline, at 4 weeks, at 8 weeks, at 12 weeks, and at 24 weeks post-baseline. Semi-structured interviews will be conducted at baseline and at 12 weeks post-baseline. Primary outcomes will be self-reported 7-day point prevalence abstinence from smoking at 12 weeks and 24 weeks. Secondary outcomes will include other smoking cessation-related outcomes, psychological outcomes, and acceptability of the nuumi intervention. Descriptive analyses and within-group comparisons will be performed on the quantitative data, and content analyses will be performed on the qualitative data. Recruitment for this study started in October 2023.DiscussionAs tobacco smoking is a leading cause of preventable morbidity and mortality, this research addresses one of the largest health burdens of our time. The results will provide insights into the initial efficacy, acceptability, and psychological outcomes of a novel mobile health intervention for smoking cessation. If successful, this pilot may generate an effective intervention supporting adults who smoke to quit smoking. The results will inform feasibility of a future randomized controlled trial.Trial Registration German Clinical Trials Register DRKS00032652, registered 09/15/2023, https://drks.de/search/de/trial/DRKS00032652.

Combining app-based behavioral therapy with electronic cigarettes for smoking cessation: a study protocol for a single-arm mixed-methods pilot trial

BackgroundCigarette smoking remains a leading cause of preventable illness and death, underscoring the need for effective evidence-based smoking cessation interventions. Nuumi, a novel smoking cessation program integrating a digital behavioral therapy and an electronic cigarette, may provide a solution.ObjectiveTo investigate the initial efficacy, acceptability and psychological outcomes of an evidence-based smoking cessation intervention comprised of a mobile phone app and an electronic cigarette among adults who smoke and who are motivated to quit.MethodsA prospective 6-month single-arm mixed-methods pilot study will be conducted. Seventy adults who smoke and who are motivated to quit will be recruited via web-based advertisements and flyers. Participants receive access to an app and an electronic cigarette with pods containing nicotine for temporary use of at least 3 months. The electronic cigarette is coupled with the app via Bluetooth, allowing for tracking of patterns of use. The behavioral therapy leverages evidence-based content informed by cognitive behavioral therapy and mindfulness-informed principles. Web-based self-report surveys will be conducted at baseline, at 4 weeks, at 8 weeks, at 12 weeks, and at 24 weeks post-baseline. Semi-structured interviews will be conducted at baseline and at 12 weeks post-baseline. Primary outcomes will be self-reported 7-day point prevalence abstinence from smoking at 12 weeks and 24 weeks. Secondary outcomes will include other smoking cessation-related outcomes, psychological outcomes, and acceptability of the nuumi intervention. Descriptive analyses and within-group comparisons will be performed on the quantitative data, and content analyses will be performed on the qualitative data. Recruitment for this study started in October 2023.DiscussionAs tobacco smoking is a leading cause of preventable morbidity and mortality, this research addresses one of the largest health burdens of our time. The results will provide insights into the initial efficacy, acceptability, and psychological outcomes of a novel mobile health intervention for smoking cessation. If successful, this pilot may generate an effective intervention supporting adults who smoke to quit smoking. The results will inform feasibility of a future randomized controlled trial.Trial Registration German Clinical Trials Register DRKS00032652, registered 09/15/2023, https://drks.de/search/de/trial/DRKS00032652.

Determining the optimal frequency of SARS-CoV-2 regular asymptomatic testing: A randomized feasibility trial in a home care setting.

The SARS-CoV-2 pandemic presented a challenge for caregiving relatives in the home care setting. Caregivers can transmit SARS-CoV-2 to their relatives who are often at high risk for a severe course of COVID-19. Regular testing of asymptomatic caregivers for SARS-CoV-2 may reduce the risk of transmission. The optimal method and frequency of regular asymptomatic testing is unknown. We conducted a prospective, randomised trial to assess the feasibility, recruitment and acceptance of different testing frequencies. This serves to inform a future definitive randomised controlled trial. We carried out a parallel three-armed feasibility trial, enrolling adult participants who provided home-based care for a relative at least twice a week. Participants were randomly assigned using sealed envelopes to either conduct saliva-based antigen self-testing at a frequency of once a week (group I), twice a week (group II), or every two days (group III). The participants completed questionnaires on a weekly basis. Main outcome measures were feasibility of recruitment, adherence to self-tests and distress caused by self-testing. We further collected data on the use of mouth-nose mask. From 25 March to 7 May 2021 we assessed 27 participants and randomised 26 in the study: 8 participants in group I, 8 in group II and 10 in group III. All participants completed the study. In group I 48/48 (100.0%; 95% CI 92.6% to 100.0%), in group II 93/96 (96.9%; 95% CI 91.2% to 98.9%) and in group III 209/210 (99.5%; 95% CI 97.4% to 99.9%) self-tests were carried out at home. Participants did not perceive regular self-testing as burdensome in any of the study arms. We did not observe any infection with SARS-CoV-2. During the study, mask adherence decreased from 35% to 19% in all groups. Conducting such a study was feasible. The participants tolerated regular self-testing well, which was reflected in a high level of test adherence. However, regular self-testing may have led to decreased protective behaviour. To demonstrate that regular asymptomatic testing reduces infection transmission, a future definitive trial should be performed at a time of a high prevalence of SARS-CoV-2 and be implemented as a multicentre study. The trial is registered with the German Clinical Trials Register, DRKS00026234.

App-Based Addiction Prevention at German Vocational Schools: Implementation and Reach for a Cluster-Randomized Controlled Trial.

This article examines the implementation, participation rates, and potential determinants of participation in the digital addiction prevention program "ready4life." A two-arm cluster-randomized trial recruited German vocational students via class-based strategies. Intervention group received 16 weeks of in-app coaching; the control group received health behavior information, with coaching offered after 12 months. Potential determinants of participation were analyzed based on class and individual characteristics. Out of 525 contacted schools, 35 participated, enrolling 376 classes. Implementation during the pandemic required flexible adjustments, with 49.7% of introductions conducted in person, 43.1% digitally via online streaming, and 7.2% received a video link via email. Despite challenges, 72.3% of the vocational students downloaded the app, and 46.7% gave informed consent. Participation rates were highest among (associate) professionals, vocational grammar school classes, classes introduced by females, younger individuals, members of the project team, and classes introduced face-to-face. Female gender, lower social competencies, lifetime cannabis use, higher problematic internet use, and higher perceived stress were associated with higher individual participation. The study highlights the importance of proactive outreach and personalized interventions for addiction prevention programs in vocational schools. While reached students aligned with the aims of the app, tailored recruitment strategies could enhance engagement among under-represented groups. The trial was registered in the German Clinical Trials Register (DRKS): DRKS00022328; registration date 09.10.2020.

Webcam technology on neonatal wards—examining the objective and subjective workload of nurses: a combined observational and survey study

BackgroundThis study was conducted to estimate the additional objective and perceived workload of nurses resulting from the use of webcams. The successful implementation of webcam technology into routine care requires an analysis to prevent adverse events of increased nursing workload.MethodsThe study took place on three neonatal wards in two University Hospitals in Germany. In the first Hospital, the study was conducted from February to July 2021; in the second one it was conducted between June and November 2021. Data were collected using a combined approach of a standardised diary questionnaire study and passive observations. The participants were accompanied in their daily work and their activities were recorded 65 nurses participated.Results2,031 h were observed in 1,630 observation blocks. In 14.74% of the observation blocks webcam activities were detected. The extent to which the nurses had webcam-related additional workloads was rated as no additional workload in 82.16% of the daily questionnaires (n = 1,026).ConclusionThe observed low workload due to the webcams is in line with the nurses’ perception. The observational data revealed, on a number of different analysis levels, that a limited additional workload was generated. There was no decrease in activity performance observed and no clear indication for interruptions due to the webcam-related activities for the nurses. However, it is important to raise awareness about the individual workload levels for the successful implementation. Additional education programs can be provided for nurses.Trial registrationThe Neo-CamCare study is registered at the German Clinical Trials Register. DRKS-ID: DRKS00017755.

Preventive Effect of Neuromuscular Training on Chemotherapy-Induced Neuropathy

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically relevant adverse effect of chemotherapy, negatively impacting patient quality of life. The lack of effective preventive or therapeutic options regarding CIPN often requires changes in cancer therapy, potentially resulting in reduced survival. To determine whether sensorimotor training (SMT) and whole-body vibration (WBV) training reduce symptoms and decrease the onset of CIPN. This prospective multicenter randomized clinical trial (STOP) followed up patients over 5 years at 4 centers in or near Cologne, Germany. Patients undergoing treatment with oxaliplatin or vinca alkaloids were recruited. Participants were recruited from May 2014 to November 2020. Data were last analyzed in June 2021. Participants in the intervention groups performed supervised SMT or WBV training sessions twice a week, each lasting approximately 15 to 30 minutes, concomitant to medical therapy. The primary end point was the incidence of CIPN. Secondary end points included subjective neuropathy symptoms, balance control, physical activity levels, quality of life, and clinical outcome. For cross-stratum evaluations, the Mantel-Haenszel test (MH) was used, and within individual strata, Fisher exact test was used for analysis. A total of 1605 patients were screened, and 1196 patients did not meet all inclusion criteria, with 251 further excluded or declining participation. A total of 158 patients (mean [SD] age, 49.1 [18.0-82.0] years; 93 [58.9%] male) were randomized into 1 of 3 groups: 55 (34.8%) in SMT, 53 (33.5%) in WBV, and 50 (31.6%) in treatment as usual (TAU). The incidence of CIPN in participants was significantly lower in both intervention groups compared to the control group (TAU): (SMT, 12 of 40 [30.0%; 95% CI, 17.9%-42.1%] and WBV, 14 of 34 [41.2%; 95% CI, 27.9%-54.5%] vs TAU, 24 of 34 [70.6%; 95% CI, 58.0%-83.2%]; P = .002 for intention to treat-MH). Patients receiving vinca alkaloids and performing SMT benefited the most. Results were more pronounced in a per-protocol analysis (>75% participation in the intervention) (SMT, 8 of 28 [28.6%; 95% CI, 16.6%-40.5%] and WBV, 9 of 24 [37.5%; 95% CI, 24.4%-50.5%] vs TAU, 22 of 30 [73.3%; 95% CI, 61.6%-85.6%]). Improvements in favor of SMT compared to TAU were found for balance control bipedal with eyes open; bipedal with eyes closed; monopedal, vibration sensitivity, sense of touch, lower leg strength, pain reduction, burning sensation, chemotherapy dose reductions, and mortality. This randomized clinical trial provides initial evidence that neuromuscular training decreases the onset of CIPN. German Clinical Trials Register: DRKS00006088.

Attentional Biases and Nonsuicidal Self-Injury Urges in Adolescents.

Nonsuicidal self-injury (NSSI) is a significant clinical concern among adolescents. Exposure to NSSI-related content on social media platforms has been suspected to potentially act as a trigger for NSSI. To use free-viewing eye-tracking and dot-probe paradigms to examine attentional bias and psychophysiological responses to NSSI-related pictorial and textual stimuli in adolescents with and without a history of NSSI. From June 2022 to April 2023, adolescent participants in Vienna, Austria with and without a history of NSSI were exposed to NSSI-related stimuli in this nonrandomized controlled trial. Data were analyzed from December 2023 to January 2024. Exposure to NSSI-related stimuli. During both tasks, subjective arousal, NSSI urges, and autonomic nervous system activity were assessed. A total of 50 adolescents in 2 groups, 25 who engaged in NSSI (mean [SD] age 15.86 [1.14] years; 19 female participants [76%]) and 25 who did not (mean [SD] age 16.40 [1.71] years; 19 female participants [76%]) were included. Adolescents with a history of NSSI-but not those without a history of NSSI-showed a clear attentional bias toward NSSI-related images during eye-tracking, as indicated by increased initial fixations (500 ms stimulus presentation mean difference, 28.64%; 95% CI, 18.31%-38.98%; P < .001; 1000 ms stimulus presentation mean difference, 18.50%; 95% CI, 9.05%-27.95%; P < .001) and longer fixation durations (500 ms mean difference, 29.51 ms; 95% CI, 4.3-54.72 ms; P < .001; 1000 ms mean difference, 39.83 ms; 95% CI, 6.90-72.76 ms; P < .001), regardless of stimulus duration. This bias was associated with a heightened urge to engage in NSSI (d = 1.22; 95% CI, 0.69-1.73; P < .001), a trend not seen in adolescents without a history of NSSI. Similarly, in the dot-probe task, only the NSSI group showed an attentional bias toward NSSI images but not toward trauma images, emphasizing the specificity of their attentional bias. Physiological measures revealed no significant differences, suggesting that viewing NSSI images is not associated with increased autonomic arousal. Textual NSSI content did not provoke an attentional bias or heighten NSSI urges in either group. In this nonrandomized controlled trial of 50 adolescents, results highlighted a specific attentional bias toward NSSI-related pictorial stimuli in adolescents with a history of NSSI, particularly a difficulty in disengaging from NSSI images. These findings contribute to understanding maladaptive information processing in NSSI and suggest implications for clinical management and cognitive models addressing NSSI triggers. German Clinical Trials Register identifier: DRKS00025905.

Influence of non-pharmaceutical interventions during the COVID-19 pandemic on respiratory viral infections - a prospective population-based cohort study.

DRKS.de, German Clinical Trials Register (DRKS), Identifier: DRKS00023418, Registered on 28 October 2020.

Depression and vaccination behavior in patients with chronic physical illness – A cross-sectional survey

ObjectiveChronically ill are vulnerable to vaccine preventable infections. Consequently, their vaccination behavior is highly relevant. Depressive comorbidities are frequent in these patients. Furthermore, these patients are mainly diagnosed, treated and vaccinated in primary care. Therefore, we aimed to investigate the associations between depression and vaccination behavior (COVID-19 and influenza) in adult chronically ill primary care patients. MethodsIn a cross-sectional survey, we examined depression (PHQ9), psychological antecedents of vaccinations (Confidence and Constraints), health care utilization, and vaccination status. Based on an effect model, descriptive statistics and mixed linear/logistic models were calculated. (German Clinical Trials Register, DRKS00030042). Resultsn = 795 patients were analyzed. Both psychological antecedents of vaccinations (Confidence and Constraints) mediated a negative association between depression and vaccination behavior, healthcare utilization mediated a positive association. The total effect of depression was negligible. ConclusionsAs the effects of vaccination readiness and healthcare utilization are opposing, different total effects depending on the study population are possible. Further studies are needed to investigate additional predictors of vaccination behavior. Practice implicationsWe suggest tackling vaccine acceptance in chronically ill through increasing confidence using communication-based interventions, for which primary care is the suitable setting. Constraints might be reduced by reminder and recall systems.

Comparing the EQ-5D-5L and stroke impact scale 2.0 in stroke patients: an analysis of measurement properties

BackgroundStroke has evolved to become a chronic disease and a major public health challenge. To adequately capture the full disease burden of stroke patients, the assessment of health-related quality of life (HRQoL) and thus the performance of respective measures is increasingly relevant. The aim of this analysis was to compare the measurement properties of two self-report instruments, the EQ-5D-5L and the Stroke Impact Scale 2.0.MethodsThe data used for the analysis was derived from a quasi-experimental case management study for mildly to moderately affected incident stroke and transient ischemic attack (TIA) patients aged ≥ 18 in Germany. Data was collected patient-individually at 3, 6 and 12 months after initial stroke. The EQ-5D-5L and SIS 2.0 were compared in terms of feasibility, ceiling and floor effects, responsiveness and known-groups validity (Kruskal-Wallis H and Wilcoxon rank-sum test).ResultsA response for all three follow-ups is available for n = 855 patients. The feasibility of the EQ-5D-5L is determined as good (completion rate: 96.4–96.6%, ≥ one item missing: 3.2 − 3.3%), whereas the SIS 2.0 is moderately feasible (overall completion rate: 44.9–46.1%, ≥ one item missing in domains: 4.7 − 28.7%). The SIS 2.0 shows substantial ceiling effects in comparable domains (physical function: 10.4 − 13%, others: 3.5–31.3%) which are mainly larger than ceiling effects in the EQ-5D-5L index (17.1–21.5%). In terms of responsiveness, the EQ-5D-5L shows small to moderate change while the SIS 2.0 presents with moderate to large responsiveness. The EQ-5D-5L index, mobility, usual activities and Visual Analogue Scale show known-groups validity (p < 0.05). Content-related domains of the SIS 2.0 show known-groups validity as well (p < 0.05). However, it is compromised in the emotion domain in both measures (p > 0.05).ConclusionsThe EQ-5D-5L seems to be slightly more suitable for this cohort. Nonetheless, the results of both measures indicate limited suitability for TIA patients. Large-scale studies concerning responsiveness and known-groups validity are encouraged.Trial registrationThe study was registered in the German Clinical Trials Register, retrospective registration on 21.09.2022. Registration ID: DRKS00030297.

Feasibility, satisfaction, and goal attainment in routine telemedicine consultation in child and adolescent psychiatry and psychotherapy.

Telehealth services were rapidly adopted during the COVID-19 pandemic, but evidence regarding the effectiveness and feasibility of telehealth services in child and adolescent mental healthcare is sparse. This study aims to investigate feasibility, satisfaction, and goal attainment in video-delivered consultations in routine care child and adolescent psychiatry and psychotherapy. A total of 1046 patients from four university child and adolescent outpatient psychiatric clinics and one university outpatient unit for child and adolescent psychotherapy were screened for study participation. We examined a) the percentage of patients considered eligible for video-delivered consultation, b) clinicians', parents' and patients' satisfaction with video consultation, c) clinicians' ratings of goal attainment in video consultation, and d) factors associated with satisfaction and goal attainment. 59% of the screening sample (n = 621) fulfilled eligibility criteria and were considered eligible for video consultation. A total of 267 patients consented to participate in the study and received a video consultation. Clinicians reported high levels of satisfaction with video consultation and high levels of goal attainment in video consultations, especially for patients scheduled for initial patient assessments. Parents and patients were also highly satisfied with the video consultations, especially if patients had less severe emotional and behavioral problems. The present findings suggest that video consultations are a feasible and well-accepted alternative to in-person consultations in child and adolescent mental health care, especially for children with less severe symptoms and for children in early phases of assessment and treatment. Limitations include the lack of a control group. The study was registered at the German Clinical Trials Registry (DRKS00023525).

Decision-making on systemic antibiotics in the management of periodontitis: A retrospective comparison of two concepts.

To retrospectively compare two approaches for the adjunctive use of systemic antibiotics in non-surgical periodontal therapy: one based on the detection of Aggregatibacter actinomycetemcomitans (Aa) and the other on age and severity of periodontitis (Age & PPD). We also assessed the additional benefit of antibiotics in reducing the need for further surgical therapy in each group. Patients of the Department of Periodontology, Goethe University Frankfurt, Germany, were screened for microbiological testing between 2008 and 2018. Patients were categorized by their microbiological result (Aa+/-) and demographic/clinical data (Age & PPD+/-). Agreement on antibiotic indication was tested. The clinical evaluation focussed on teeth with probing pocket depths (PPDs) ≥ 6 mm. Analysis of 425 patients revealed 30% categorized as Age & PPD+ and 34% as Aa+. Sixty-three percent had consistent antibiotic recommendations (phi coefficient 0.14, p = .004). Patients in the Age & PPD+ group receiving antibiotics showed the most substantial reduction in the number of teeth with PPD ≥ 6 mm after non-surgical periodontal therapy. Both strategies resulted in a significant clinical improvement compared with those without antibiotic treatment and restricted antibiotic use similarly, but targeted different patient groups. Younger individuals with severe periodontitis benefited most from antibiotics, reducing the need for additional surgeries. The study was registered in an international trial register (German Clinical Trial Register number DRKS00028768, registration date 27 April 2022, https://drks.de/search/en/trial/DRKS00028768).

Medial malleolar osteotomy in the treatment of osteochondral lesions of the Talus – incidence and impact on functional outcome: a retrospective analysis based on data from the German Cartilage Register (KnorpelRegister DGOU)

BackgroundThere has long been discussion regarding the impact of medial malleolar osteotomies (MMO) as an adjunctive treatment for osteochondral lesions of the talus (OCLT). MMO may improve the visibility and accessibility of the talus, but they also pose a risk of periprocedural morbidity. There is a lack of research about the prevalence and consequences of MMO in the surgical treatment of OCLT.MethodsThis study retrospectively evaluated data from the German Cartilage Register (KnorpelRegister DGOU) from its implementation in 2015 to December 2020. The impact of MMO on patient-reported outcome measures (PROMs) was investigated. Wherever possible, subgroups were built and matched using a propensity score which matched a group undergoing OCLT without MMO. Matching included age, sex, weight, localization of the OCLT, the international cartilage repair society (ICRS) grading, surgical procedure and preoperative symptoms using the Foot and Ankle Ability Measure (FAAM) and the Activities of Daily Living Subscale (ADL).ResultsThe prevalence of MMO in the operative treatment of OCLT was 15.9%. Most of the osteotomies were performed in OCL of the medial talar dome (76.8%) and in more serious lesions with an ICRS grade of III (29.1%) and IV (61.4%). More than half of the osteotomies (55.6%) were performed during revision surgery. A matched pair analysis of n = 44 patients who underwent AMIC® via arthrotomy and MMO vs. arthrotomy alone showed no significant differences in patient-reported outcome measures (PROMs, i.e. FAAM-ADL, and FAOS) at 6,12 and 24 months.ConclusionsMMO are mostly used in the treatment of severe (≥ ICRS grade 3) OCL of the medial talar dome and in revision surgery. Functional and patient-reported outcome measures are not significantly affected by MMO compared to arthrotomy alone.Trial registrationThe German Cartilage Register (KnorpelRegister DGOU) was initially registered at the German Clinical Trials Register (https://www.drks.de, register number DRKS00005617, Date of registration 03.01.2014) and was later expanded by the ankle module.

Effects of flexor reflex stimulation on gait aspects in stroke patients: randomized clinical trial.

Gait deficits are very common after stroke and therefore an important aspect in poststroke rehabilitation. A currently little used method in gait rehabilitation after stroke is the activation of the flexor reflex (FR) by electrical stimulation of the sole of foot while walking. The aim of this study wasto investigate the effect of FR stimulation on gait performance and gait parameters in participants with stroke within a single session of flexor reflex stimulation using Incedo™. Twenty-five participants with subacute (n = 14) and chronic (n = 11) stroke were enrolled in the study. Motor functions were tested with a 10-m walk test (10mWT), a 2-min walk test (2minWT), and a gait analysis. These tests were performed with and without Incedo™ within a single session in randomized order. In the 10mWT, a significant difference was found between walking with Incedo™ (15.0 ± 8.5s) versus without Incedo™ (17.0 ± 11.4s, p = 0.01). Similarly, the 2minWT showed a significant improvement with Incedo™ use (90.0 ± 36.4m) compared to without Incedo™ (86.3 ± 36.8m, p = 0.03). These results indicate that while the improvements are statistically significant, they are modest and should be considered in the context of their clinical relevance. The gait parameters remained unchanged except for the step length. A subgroup analysis indicated that participants with subacute and chronic stroke responded similarly to the stimulation. There was a correlation between the degree of response to electrostimulation while walking and degree of improvement in 2minWT (r = 0.50, p = 0.01). This study is the first to examine FR activation effects in chronic stroke patients and suggests that stimulation effects are independent of the time since stroke. A larger controlled clinical trial is warranted that addresses issues as the necessary number of therapeutical sessions and for how long stimulation-induced improvements outlast the treatment period. The trial was retrospectively registered in German Clinical Trials Register. DRKS00021457. Date of registration: 29 June 2020.

Effects of a Chatbot-Based Intervention on Stress and Health-Related Parameters in a Stressed Sample: Randomized Controlled Trial.

Stress levels and the prevalence of mental disorders in the general population have been rising in recent years. Chatbot-based interventions represent novel and promising digital approaches to improve health-related parameters. However, there is a lack of research on chatbot-based interventions in the area of mental health. The aim of this study was to investigate the effects of a 3-week chatbot-based intervention guided by the chatbot ELME, specifically with respect to the ability to reduce stress and improve various health-related parameters in a stressed sample. In this multicenter two-armed randomized controlled trial, 118 individuals with medium to high stress levels were randomized to the intervention group (n=59) or the treatment-as-usual control group (n=59). The ELME chatbot guided participants of the intervention group through 3 weeks of training based on the topics stress, mindfulness, and interoception, with practical and psychoeducative elements delivered in two daily interactive intervention sessions via a smartphone (approximately 10-20 minutes each). The primary outcome (perceived stress) and secondary outcomes (mindfulness; interoception or interoceptive sensibility; subjective well-being; and emotion regulation, including the subfacets reappraisal and suppression) were assessed preintervention (T1), post intervention (T2; after 3 weeks), and at follow-up (T3; after 6 weeks). During both conditions, participants also underwent ecological momentary assessments of stress and interoceptive sensibility. There were no significant changes in perceived stress (β03=-.018, SE=.329; P=.96) and momentary stress. Mindfulness and the subfacet reappraisal significantly increased in the intervention group over time, whereas there was no change in the subfacet suppression. Well-being and momentary interoceptive sensibility increased in both groups over time. To gain insight into how the intervention can be improved to achieve its full potential for stress reduction, besides a longer intervention duration, specific sample subgroups should be considered. The chatbot-based intervention seems to have the potential to improve mindfulness and emotion regulation in a stressed sample. Future chatbot-based studies and interventions in health care should be designed based on the latest findings on the efficacy of rule-based and artificial intelligence-based chatbots. German Clinical Trials Register DRKS00027560; https://drks.de/search/en/trial/DRKS00027560. RR2-doi.org/10.3389/fdgth.2023.1046202.

Balance function in critical illness survivors and evaluation of psychometric properties of the Mini-BESTest

Critical illness survivors commonly face impairments, such as intensive care unit-acquired weakness (ICUAW) which is characterized by muscle weakness and sensory deficits. Despite these symptoms indicating potential balance deficits, systematic investigations and validated assessments are lacking. Therefore, we aimed to assess balance function using the Mini-BESTest, evaluate its psychometric properties, and identify associated variables. Balance was assessed post-ICU discharge (V1) and at discharge from inpatient neurorehabilitation (V2) in patients with ≥ 5 days of invasive ventilation. Mini-BESTest measurement characteristics were evaluated in an ambulatory subgroup. A multiple linear regression was conducted. The prospective cohort study comprised 250 patients (34% female, 62 ± 14 years, median ICU stay 55 days). Median Mini-BESTest scores improved significantly from V1 (5 (IQR 0–15)) to V2 (18.5 (10–23)) with a large effect size. Excellent inter-rater and test–retest reliabilities of the Mini-BESTest were observed (ICC = 0.981/0.950). Validity was demonstrated by a very high correlation with the Berg Balance Scale (ρ = 0.90). No floor or ceiling effects were detected. Muscle strength, cognitive function, cerebral disease, critical illness polyneuropathy/myopathy, and depression were significantly associated with balance. Despite significant improvements during the rehabilitation period, balance disorders were prevalent in critical illness survivors. Ongoing therapy is recommended. Due to its excellent psychometric properties, the Mini-BESTest is suitable for use in critical illness survivors.Registration: The study was registered at the German Clinical Trials Register (DRKS00021753, date of registration: 2020-09-03).