Needs, preferences, and patient participation for a randomized controlled trial on postneoadjuvant complete tumor response: A qualitative study of patients with esophageal cancer.

PURPOSE: For patients with clinical complete response of non-metastatic esophageal cancer (EC) after neoadjuvant chemoradiotherapy (nCRT) or neoadjuvant chemotherapy (nCT), the two treatment options obligate postneoadjuvant surgery as the current standard treatment (surgery on principle) versus active surveillance with surgery as needed only in recurring loco-regional tumor as a possible future alternative or standard exist. Since these treatments are presumably equivalent in terms of overall survival, patient-centered information can encourage the discussion with the treating physician and can make it easier for patients to make trade-offs between the advantages and disadvantages of the treatment alternatives in a highly distressed situation. METHODS: A qualitative prospective cross-sectional study was conducted to create patient-centered information material that is based on patients' preferences, needs, and concerns regarding the two treatment options, and to investigate the potential participation in a consecutive randomized controlled trial (RCT). Therefore, EC patients (N = 11) were asked about their attitudes. RESULTS: Concerns about the surgery and possible postoperative impairments in quality of life were identified as most mentioned negative aspects of surgery on principle, and recurrence and progression fear and the concern that surgery cannot be avoided anyways as most named negative aspects of surgery as needed. In regard to the participation in an RCT, making a contribution to science and the hope that the novel therapy would be superior to the established one were relevant arguments to participate. On the other hand, the lack of a proactive selection of treatment was named an important barrier to participation in an RCT. CONCLUSION: The importance of adapting medical conversations to the patients' lack of expertise and their exceptional cognitive and emotional situation is stressed. Results of this study can be used to improve patient-centered information and the recruitment of patients in RCTs in cancer.

Neural substrates of tinnitus severity.

Subjective chronic tinnitus is a prevalent auditory perception characterized by an absence of a corresponding acoustic source. It is often accompanied by hearing deficits and may lead to various psychological problems including sleep disorder, depression and anxiety. To investigate the differential neuronal profile of patients with severe and less severe chronic tinnitus, 34 tinnitus patients were distributed in two groups and their EEG resting state activity was compared. Using standardized Low Resolution Electromagnetic Tomography (sLORETA) a significant and substantial frontal increase in theta wave activity was found in the group with severe tinnitus (p = .013). The correlated severity of depression and anxiety had no influence on the electrophysiological metric. These results support a tinnitus-related global network change in which prefrontal areas are part of a network which exerts a top-down influence on the auditory cortices. The demonstrated slowing of oscillations in the responsible network may constitute a neuronal marker for the prefrontal brain network lacking the capacity to inhibit overexcitation. The magnitude of this influence is linked to the subjective strength of the tinnitus distress.

Psychophysiological treatment of chronic tinnitus: A review.

Subjective chronic tinnitus consists of a more or less continuous perception of sound in the absence of a corresponding acoustic source, which can lead to various psychological problems like depression, anxiety, attentional deficits and sleep disturbances. The prevalence is 10%-15% of the general population. Various therapy and management options have been proposed, but outcomes vary, and no generally accepted cure exists. In this review, the coherence of the most frequently used aetiological models shall be evaluated, and the efficacy of several treatment options will be discussed. With respect to tinnitus treatments, we focus on controlled studies and meta-analyses. Although there are some therapies that outweigh placebo effects such as cognitive behavioural therapy, neurofeedback or neuromodulation techniques, they mainly target secondary symptoms and not the tinnitus tone itself. Furthermore, positive treatment effects only seem to last for a limited period of time. We conclude that long-lasting combination therapies such as neurofeedback of auditory cortex inhibitory EEG signatures, cognitive therapy and sound-tactile stimulation may provide more efficient outcomes if they target the intensity of the tinnitus tone itself and not only secondary psychological symptoms.

Presurgical Screening Improves Risk Prediction for Delirium in Elective Surgery of Older Patients: The PAWEL RISK Study.

Introduction: The number of elective surgeries for patients who are over 70 years of age is continuously growing. At the same time, postoperative delirium (POD) is common in older patients (5-60%) depending on predisposing risk factors, such as multimorbidity, cognitive impairment, neurodegenerative disorders and other dementing disorders, and precipitating factors, such as duration of surgery. Knowledge of individual risk profiles prior to elective surgery may help to identify patients at increased risk for development of POD. In this study, clinical and cognitive risk factors for POD were investigated in patients undergoing various elective cardiac and non-cardiac surgeries. Methods: The PAWEL study is a prospective, interventional trial on delirium prevention. At baseline, 880 inpatients at five surgical centers were recruited for sub-sample PAWEL-R. Multimodal assessments included clinical renal function, medication, American Society of Anesthesiologists (ASA) Physical Status Classification System, geriatric and cognitive assessments, which comprised the Montreal Cognitive Assessment Scale (MoCA), Trail-making Test, and Digit Span backward. Delirium incidence was monitored postoperatively by the Confusion Assessment Method (CAM) and a chart review for up to a week or until discharge. Multivariate regression models and Chi-square Automatic Interaction Detectors (CHAID) analyses were performed using delirium incidence as the primary outcome. Results: Eighteen risk factors were investigated in elective cardiovascular and orthopedic or general surgery. A total of 208 out of 880 patients (24%) developed POD. A global regression model that included all risk variables predicted delirium incidence with high accuracy (AUC = 0.81; 95% CI 0.77, 0.85). A simpler model (clinical and cognitive variables; model CLIN-COG) of 10 factors that only included surgery type, multimorbidity, renal failure, polypharmacy, ASA, cut-to-suture time, and cognition (MoCA, Digit Span backward, and preexisting dementia), however, exhibited similar predictive accuracy (AUC = 0.80; 95% CI 0.76, 0.84). Conclusion: The risk of developing POD can be estimated by preoperative assessments, such as ASA classification, expected cut-to-suture time, and short cognitive screenings. This rather efficient approach predicted POD risk over all types of surgery. Thus, a basic risk assessment including a cognitive screen can help to stratify patients at low, medium, or high POD risk to provide targeted prevention and/or management strategies for patients at risk.

Study Protocol of a Prospective Multicenter Study on Patient Participation for the Clinical Trial: Surgery as Needed Versus Surgery on Principle in Post-Neoadjuvant Complete Tumor Response of Esophageal Cancer (ESORES).

Ideally, patient-centered trial information material encourages the discussion with the treating physician, and helps patients making trade-offs regarding treatment decisions In a situation of possible equivalent treatment options in terms of overall survival (OS), it can make it easier to weigh up advantages and disadvantages. Preferences for choice of treatment in esophageal cancer (EC) are complex, and no standardized assessment tools are available. We will explore patient's factors for treatment choice and develop a comprehensive patient information leaflet for the inclusion into randomized controlled trials (RCT) on EC. We conduct a cross-sectional, observational study based on a mixed-methods design with patients suffering from non-metastatic EC with post-neoadjuvant complete response after neoadjuvant chemotherapy (nCT) or neoadjuvant chemoradiation (nCRT), to develop patient-centered trial information material. This pilot study is performed in a concept development phase and a subsequent pilot phase. We start with patient interviews (n = 10-15) in the concept development phase to evaluate patients' needs, and develop a Preference and Decision Aid Questionnaire (PDAQ). We pre-test the PDAQ with another n = 10 patients with EC after nCT or nCRT, former patients from a self-help organization, and n = 10 medical experts for their comments on the questionnaire. In the pilot phase, a multicenter trial using the PDAQ and additional measures is carried out (n = 120). Based on evidence of a possible equivalence in terms of OS of the treatment options "surgery as needed" and "surgery on principle" in patients with post-neoadjuvant complete response of EC, this pilot study on patient participation is conducted to assess patient's needs and preferences, and optimize patients' inclusion in a planned RCT. The aim is to develop patient-centered trial information material for the RCT to increase patients' consent and compliance with the randomized treatment. The trial is registered at the German Clinical Trials Register (DRKS00022050, October 15, 2020).

Symptom and performance validation in patients with subjective cognitive decline and mild cognitive impairment.

Nonauthentic symptom claims (overreporting) and invalid test results (underperformance) can regularly be expected in a forensic context, but may also occur in clinical referrals. While the applicability of symptom and performance validity tests in samples of dementia patients is well studied, the same is not true for patients with subjective cognitive decline (SCD) and mild cognitive impairment (MCI). A sample of 54 memory-clinic outpatients with evidence of SCD or MCI was studied. We evaluated the rate of positive results in three validity measures. A total of 7.4% of the patients showed probable negative response bias in the Word Memory Test. The rate of positive results on the Structured Inventory of Malingered Symptomatology was 14.8% while only one participant (1.9%) scored positive on the Self-Report Symptom Inventory using the standard cutoff. The two questionnaires were moderately correlated at .67. In a combined analysis of all results, five of the patients (9.3%) were judged to show evidence of probable negative response bias (or probably feigned neurocognitive impairment). In the current study, a relatively small but nontrivial rate of probable response distortions was found in a memory-clinic sample. However, it remains a methodological challenge for this kind of research to reliably distinguish between false-positive and correct-positive classifications in clinical patient groups.

Real-time monitoring and regulating auditory cortex alpha activity in patients with chronic tinnitus.

OBJECTIVE: Low levels of alpha activity (8-13Hz) mirror a state of enhanced responsiveness, whereas high levels of alpha are a state of reduced responsiveness. Tinnitus is accompanied by reduction of alpha activity in the perisylvian regions compared to normal hearing controls. This reduction might be a key mechanism in the chain of reactions leading to tinnitus. We devised a novel spatial filter as an on-line source monitoring method, which can be used to control alpha activity in the primary auditory cortex. In addition, we designed an innovative experimental procedure to enable suppression of visual and somatosensory alpha, facilitating auditory alpha control during alpha neurofeedback. APPROACH: An amplitude-modulated auditory stimulation with 40 Hz modulation frequency and 1000 Hz carrier frequency specifically activates the primary auditory cortex. The topography of 40 Hz oscillation depicts the activity of the auditory cortices. We used this map as a spatial filter, which passes the activity originating from the auditory cortex. To suppress superposition of auditory alpha by somatosensory and visual alpha, we used a continuous tactile jaw-stimulation and visual stimulation protocol to suppress somatosensory alpha of regions adjacent to the auditory cortex and visual alpha for local regulation of auditory alpha activity only. MAIN RESULTS: This novel spatial filter for online detection of auditory alpha activity and the usage of multi-sensory stimulation facilitate the appearance of alpha activity from the auditory cortex at the sensor level. SIGNIFICANCE: The proposed procedure can be used in an EEG-neurofeedback-treatment approach allowing online auditory alpha self-regulation training in patients with chronic tinnitus.