Use of Patient-Reported Outcome Measures and Patient-Reported Experience Measures Within Evaluation Studies of Telemedicine Applications: Systematic Review.

BACKGROUND: With the rise of digital health technologies and telemedicine, the need for evidence-based evaluation is growing. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are recommended as an essential part of the evaluation of telemedicine. For the first time, a systematic review has been conducted to investigate the use of PROMs and PREMs in the evaluation studies of telemedicine covering all application types and medical purposes. OBJECTIVE: This study investigates the following research questions: in which scenarios are PROMs and PREMs collected for evaluation purposes, which PROM and PREM outcome domains have been covered and how often, which outcome measurement instruments have been used and how often, does the selection and quantity of PROMs and PREMs differ between study types and application types, and has the use of PROMs and PREMs changed over time. METHODS: We conducted a systematic literature search of the MEDLINE and Embase databases and included studies published from inception until April 2, 2020. We included studies evaluating telemedicine with patients as the main users; these studies reported PROMs and PREMs within randomized controlled trials, controlled trials, noncontrolled trials, and feasibility trials in English and German. RESULTS: Of the identified 2671 studies, 303 (11.34%) were included; of the 303 studies, 67 (22.1%) were feasibility studies, 70 (23.1%) were noncontrolled trials, 20 (6.6%) were controlled trials, and 146 (48.2%) were randomized controlled trials. Health-related quality of life (n=310; mean 1.02, SD 1.05), emotional function (n=244; mean 0.81, SD 1.18), and adherence (n=103; mean 0.34, SD 0.53) were the most frequently assessed outcome domains. Self-developed PROMs were used in 21.4% (65/303) of the studies, and self-developed PREMs were used in 22.3% (68/303). PROMs (n=884) were assessed more frequently than PREMs (n=234). As the evidence level of the studies increased, the number of PROMs also increased (τ=-0.45), and the number of PREMs decreased (τ=0.35). Since 2000, not only has the number of studies using PROMs and PREMs increased, but the level of evidence and the number of outcome measurement instruments used have also increased, with the number of PREMs permanently remaining at a lower level. CONCLUSIONS: There have been increasingly more studies, particularly high-evidence studies, which use PROMs and PREMs to evaluate telemedicine. PROMs have been used more frequently than PREMs. With the increasing maturity stage of telemedicine applications and higher evidence level, the use of PROMs increased in line with the recommendations of evaluation guidelines. Health-related quality of life and emotional function were measured in almost all the studies. Simultaneously, health literacy as a precondition for using the application adequately, alongside proper training and guidance, has rarely been reported. Further efforts should be pursued to standardize PROM and PREM collection in evaluation studies of telemedicine.

Multimodal Treatment of Patients with Mental Symptom Load: A Pre-Post Comparison.

The Traditional Chinese Medicine (TCM) Hospital in Bad Kötzting, Germany, is treating chronically ill patients, covering a broad range of indications. The aim of this study was to prove the efficacy of a multimodal intervention combining mainstream medicine with TCM treatments on the severity of psychopathological symptoms. Out of 966 patients with chronic psychosomatic disease treated 2017 at the TCM Hospital, we selected 759 patients according to specific criteria and analyzed the outcomes after multimodal intervention. The patients completed a validated questionnaire (International Statistical Classification of Diseases (ICD) Symptom-Rating-(ISR)) at admission, discharge, and follow-up. The most frequent ICD-10 diagnoses were "diseases of the musculoskeletal system and connective tissue" (28.5%), "mental and behavioral disorders" (23.7%), and "diseases of the nervous system" (13.8%). Regarding ISR symptom load, "depressive syndrome" and "anxiety syndrome" were the leading burdens showing remissions of about 40%-60% with moderate (0.588) to strong (1.115) effect sizes (Cohen's d) after treatment. ISR total scores at discharge and follow-up were remarkably lower after intervention (0.64 and 0.75, respectively) compared to 1.02 at admission with moderate to strong effect sizes (0.512-0.815). These findings indicate a clinically relevant relief from mental symptom load after intervention with lasting clinical effects for at least six months.

Herbal Traditional Chinese Medicine and suspected liver injury: A prospective study.

AIM: To analyze liver tests before and following treatment with herbal Traditional Chinese Medicine (TCM) in order to evaluate the frequency of newly detected liver injury. METHODS: Patients with normal values of alanine aminotransferase (ALT) as a diagnostic marker for ruling out pre-existing liver disease were enrolled in a prospective study of a safety program carried out at the First German Hospital of TCM from 1994 to 2015. All patients received herbal products, and their ALT values were reassessed 1-3 d prior to discharge. To verify or exclude causality for suspected TCM herbs, the Roussel Uclaf Causality Assessment Method (RUCAM) was used. RESULTS: This report presents for the first time liver injury data derived from a prospective, hospital-based and large-scale study of 21470 patients who had no liver disease prior to treatment with herbal TCM. Among these, ALT ranged from 1 × to < 5 × upper limit normal (ULN) in 844 patients (3.93%) and suggested mild or moderate liver adaptive abnormalities. However, 26 patients (0.12%) experienced higher ALT values of ≥ 5 × ULN (300.0 ± 172.9 U/L, mean ± SD). Causality for TCM herbs was RUCAM-based probable in 8/26 patients, possible in 16/26, and excluded in 2/26 cases. Bupleuri radix and Scutellariae radix were the two TCM herbs most commonly implicated. CONCLUSION: In 26 (0.12%) of 21470 patients treated with herbal TCM, liver injury with ALT values of ≥ 5 × ULN was found, which normalized shortly following treatment cessation, also substantiating causality.

East Meets West: Synergy through Diversity.

The TCM hospital Bad Kötzting is historically the first inpatient facility in Germany with an emphasis on Traditional Chinese Medicine (TCM). The clinic's specialty is the multimodal treatment of somatic complaints in conjunction with acute psychological or psychiatric comorbidity. Most patients present with clinical problems of a high degree of chronicity and complexity. Over the past 25 years the treatment concept of the hospital has developed from a strictly TCM approach to a multimodal combination of TCM, psychosomatic medicine, and lifestyle medicine. This article outlines the admission and intake procedures and describes the process of determining the TCM diagnoses and treatment protocols. A typical case study illustrates this process in more details. Then, we present the various components of the psychotherapeutic and psychoeducational programs, including innovative approaches to lifestyle medicine. In conclusion, the treatment program at the TCM hospital Bad Kötzting has developed into a multimodal approach that synergistically intertwines diverse therapies drawn from Eastern and Western traditions, effectively combining the best approaches of both contexts.

Quality Control and Complication Screening Programme of Chinese Medicinal Drugs at the First German Hospital of Traditional Chinese Medicine - A Retrospective Analysis.

BACKGROUND: The use of drugs derived from plants is a cornerstone of Traditional Chinese Medicine (TCM). Yet, too little is known about risk and safety of Chinese medicinal drugs (CMD). Therefore, the TCM hospital Bad Kötzting has developed a quality control and complication screening programme in order to ensure a safe administration of TCM drugs to their patients. METHODS: All Chinese medicinal drugs delivered to the hospital between September 1, 2012 and December 31, 2013 entered the quality control program and were screened for microbial contamination, aflatoxin, pesticides and heavy metals. A routinely applied complication screening programme monitored liver enzymes in all patients. Case causality assessment by CIOMS scale and identification of admitted herbs were conducted. Additionally, side effects of patients were identified by a routinely performed web-based documentation system. RESULTS: In 5 of 23 investigated samples (21.7%) the initial testing showed microbial contamination (2), pesticide (2) and heavy metals (1). The drugs were tested for authenticity and adulterations, respectively. All 994 patients (mean age 52.6 years; 72.6% female) admitted were available for analysis. 448 (45.1%) of all patients reported having perceived at least one side effect of treatment. They experienced mainly gastrointestinal symptoms (13.6%), neurovegetative symptoms (10.8 %), temporary deteriorations of pain (8.8%), diarrhoea (5.9%), nausea (1.6%) and vomiting (0.5%). Further, 6 patients with a more than 2-fold elevation (compared to maximum normal value or elevated admission values) of ALT were found in the systematic laboratory control with a non-conclusive causality assessment for TCM-drugs. CONCLUSION: Approximate incidence rates and analysed drugs associated with liver damage revealed a low rate of liver injury. Patients should be informed of the gastrointestinal symptoms caused by and potential hepatotoxicity of TCM herbs.

[On the reliability of the description of morphological characteristics in traditional Chinese tongue diagnostics]. / Zur Reliabilität der Beschreibung morphologischer Merkmale in der traditionellen chinesischen Zungendiagnostik.

BACKGROUND AND OBJECTIVE: The assessment of the tongue is a crucial diagnostic tool of traditional Chinese medicine. In a series of studies we aimed to investigate to what extent independent raters agree in the description of morphological tongue characteristics. METHODS: In two pilot studies (n = 15 each) and one larger study (n= 101) two to three physicians experienced in traditional Chinese medicine assessed morphological characteristics in digital photos of tongues by use of a rating form and under blind conditions. The primary outcome measure was agreement beyond chance (Cohen's kappa). RESULTS: Kappa values varied strongly in the first pilot study(-0.15 to 0.76) and for many items, agreement was weak or moderate. In the second pilot study which used improved methods kappa values still varied considerably(-0.10 to 1.00), but for 7 out of the 18 items assessed there was an excellent agreement (kappa > or =0.75). In the confirmatory study, kappa values ranged between 0.15 and 0.83. DISCUSSION: The performed studies have to be seen as a first attempt to develop adequate methods in order to systematically investigate the reliability of traditional Chinese tongue diagnostics. The study findings suggest that the description of morphological characteristics within traditional Chinese tongue diagnostics has acceptable reliability.

Profiling quality of care for patients with chronic headache in three different German hospitals - a case study.

BACKGROUND: Legal requirements for quality assurance in German rehabilitation hospitals include comparisons of providers. Objective is to describe and to compare outcome quality of care offered by three hospitals providing in-patient rehabilitative treatment exemplified for patients with chronic headache. METHODS: We performed a prospective three center observational study on patients suffering from chronic headache. Patients underwent interventions commonly used according to internal guidelines of the hospitals. Measurements were taken at three points in time (at admission, at discharge and 6 months after discharge). Indicators of outcome quality included pain intensity and frequency of pain, functional ability, depression, quality of life and health related behavior. Analyses of differences amongst the hospitals were adjusted by covariates due to case-mix situation. RESULTS: 306 patients from 3 hospitals were included in statistical analysis. Amongst the hospitals, patients differed significantly in age, education, diagnostic subgroups, beliefs, and with respect to some pain-related baseline values (covariates). Patients in all three hospitals benefited from intervention to a clinically relevant degree. At discharge from hospital, outcome quality differed significantly after adjustment according to case-mix only in terms of patients' global assessment of treatment results. Six months after discharge, the only detectable significant differences were for secondary outcomes like improved coping with stress or increased use of self-help. The profiles for satisfaction with the hospital stay showed clear differences amongst patients. CONCLUSION: The results of this case study do not suggest a definite overall ranking of the three hospitals that were compared, but outcome profiles offer a multilayer platform of reliable information which might facilitate decision making.

Presentation, patterns of myocardial damage, and clinical course of viral myocarditis.

BACKGROUND: Enteroviruses and adenoviruses have been considered the most common causes of viral myocarditis, but parvovirus B19 (PVB19) and human herpesvirus 6 (HHV6) are increasingly found in endomyocardial biopsy samples. METHODS AND RESULTS: Consequently, our aim was to evaluate the prevalence and clinical presentation of cardiac PVB19 and/or HHV6 infection in a cohort of myocarditis patients and to follow its clinical course. In addition, we sought to demonstrate patterns of myocardial damage and to determine predictors for chronic heart failure. Our study design consisted of a cardiovascular magnetic resonance protocol as well as endomyocardial biopsies in the myocardial region affected as indicated by cardiovascular magnetic resonance. One hundred twenty-eight patients were enrolled by clinical criteria. In the group of myocarditis patients (n=87), PVB19 (n=49), HHV6 (n=16), and combined PVB19/HHV6 infections (n=15) were detected most frequently. The remaining patients were diagnosed with healing myocarditis (n=15) or did not have myocarditis (n=26). Patients with PVB19 presented in a manner similar to that of myocardial infarction; most had typical subepicardial late gadolinium enhancement in the lateral wall and recovered within months. Conversely, patients with HHV6 and especially with HHV6/PVB19 myocarditis presented with new onset of heart failure, had septal late gadolinium enhancement, and frequently progressed toward chronic heart failure. CONCLUSIONS: Our data indicate that PVB19 and HHV6 are the most important causes for viral myocarditis in Germany and that the clinical presentation is related to the type of virus. Furthermore, clinical presentation, type of virus, and pattern of myocardial damage are related to the clinical course.

Effects of time, dose, and inversion time for acute myocardial infarct size measurements based on magnetic resonance imaging-delayed contrast enhancement.

OBJECTIVES: This study sought to investigate the influence of time, dose, and inversion time (TI) and their interactions on myocardial infarct size measurements to establish the foundation for a standardized protocol for multicenter trials. BACKGROUND: There is growing interest in using magnetic resonance imaging (MRI) infarct size measurements as an end point in clinical trials. However, no standardized protocol exists, and there are limited data concerning the effects of time, contrast agent dose, and TI. METHODS: First, we determined the influence of postcontrast imaging time (5 to 40 min), contrast agent dose (0.1 vs. 0.2 mmol/kg), TI, and their interactions in an animal model (n = 14). Second, we tested whether the findings of the animal study apply to patients and are generalizable. Therefore, we retested the diagnostic window in a multicenter study. A total of 48 patients with first acute myocardial infarction (AMI) from three centers were imaged twice (5 and 30 min) after injection of 0.15 mmol/kg gadolinium diethylenetriamine-pentaacetate using an adjusted TI. RESULTS: The animal study showed that the infarct size is independent of time and dose (p = 0.9 and p = 0.16, respectively) using an adjusted TI. Using a fixed TI, however, infarct size is a function of time and dose (p = 0.0001 and p = 0.01, respectively). The multicenter study showed that MRI 1 (16.9 +/- 12% of left ventricle) was not statistically different from MRI 2 (16.4 +/- 12% of left ventricle, p = NS) with no difference between sites (p = NS). CONCLUSIONS: The AMI size can be measured with MRI using a contrast dose between 0.1 and 0.2 mmol/kg and a time window of 5 to 30 min after contrast administration, provided that the TI is adjusted.

Left ventricular wall motion abnormalities as well as reduced wall thickness can cause false positive results of routine SPECT perfusion imaging for detection of myocardial infarction.

AIMS: The relationship between wall thickness, wall thickening, wall motion, and single-photon emission computed tomography (SPECT) results for detection of myocardial infarction has never been systematically evaluated in a clinical setting. In particular, the discussion whether non-ischaemic regional wall motion abnormalities and reduced wall thickness can cause SPECT to be false positive for infarct detection remains unsettled. METHODS AND RESULTS: We therefore evaluated patients presenting with left bundle branch block (LBBB) and only included them in the analysis if any coronary artery disease (CAD) had been ruled out by angiography. LBBB is known to cause septal wall motion abnormalities as well as to reduce systolic septal wall thickness. Thus, LBBB is a good non-ischaemic clinical model to evaluate the influence of wall thickness and wall motion on the homogeneity of tracer distribution in resting SPECT images. SPECT revealed fixed defects in all 139 patients initially identified for possible enrollment. CAD was found to be present by angiography in 120 patients. The remaining 19 patients without any CAD underwent cardiovascular magnetic resonance (CMR) and were included in the study. Evaluation of SPECT using a 72-segment model revealed septum-related fixed defects in all 19 patients. Every defect was interpreted as myocardial infarction by blinded observers. The comparison of nuclear results to the gold standard CMR demonstrated that none of the fixed SPECT defects did represent myocardial infarcts. Defects, however, exactly matched areas of wall motion abnormalities as well as regions with impaired wall thickness as demonstrated by CMR. On a segmental basis, we found a strong relationship between wall motion and reduced wall thickness on one hand and SPECT defects on the other hand. For example, only 5% of segments with normal wall motion were false positive by SPECT for myocardial infarction, whereas 93% of all dyskinetic segments were found to be false positive (P<0.01). Comparing wall thickness to SPECT results revealed that 58% of segment in which wall thickness was 1 SD below the mean and 93% of segments in which wall thickness was 2 SD below the mean showed fixed defects by SPECT. Conversely, only 0.5% of segments in which wall thickness was above the mean were affected by false positive SPECT results (P<0.01). CONCLUSION: Wall motion abnormalities as well as impaired myocardial wall thickening and wall thickness can cause false positive results of resting SPECT myocardial perfusion imaging for detection of myocardial infarction in the absence of myocardial infarct scars and CAD.

Age, metabolic control and type of insulin regime influences health-related quality of life in children and adolescents with type 1 diabetes mellitus.

UNLABELLED: The effects of illness and treatment of diabetes mellitus extend beyond medical outcomes. We therefore evaluated health-related quality of life (HRQOL) in children (aged 8-12 years) and adolescents (aged 13-16 years) with type 1 diabetes to compare their results with healthy peers and to identify HRQOL determinants. A total of 68 children and adolescents from a tertiary care clinic which specialises in the management of diabetes, completed the generic KINDL-R questionnaire. This instrument for children and adolescents has six dimensions and an additional module assessing condition-related HRQOL. Overall, the HRQOL was not different between patients with type 1 diabetes and healthy controls. In some areas, children and adolescents with diabetes reported a better HRQOL compared to healthy peers: adolescents reported better psychological well-being (P < 0.05) and children higher levels of well-being in the school domain (P < 0.05). In general, children reported a better HRQOL (P < 0.05) than adolescents with type 1 diabetes confirming age-related differences in HRQOL in the general population. Lower HbA1c (<8%) and intensified insulin therapy (>3 injections/day) were associated with a better HRQOL in different domains (P < 0.05). The subscale "chronic illness" showed a better HRQOL (P < 0.001) in children and adolescents with diabetes compared to age-matched controls with other chronic conditions. CONCLUSION: Children and adolescents from a paediatric department specialising in diabetes management report good health-related quality of life. Younger age, good metabolic control and intensified insulin therapy are associated with a better health-related quality of life. Dimensions of health-related quality of life appear to play different roles at different ages, emphasising the importance of the multidimensional health-related quality of life concept and the value of age-appropriate self-reports.

Treatment of patients with chronic headaches in a hospital for traditional Chinese medicine in Germany. A randomised, waiting list controlled trial.

OBJECTIVE: To investigate the effectiveness of a clinical treatment program with traditional Chinese medicine for migraine and tension-type headache. METHODS: Ninety-one patients with migraine, episodic or chronic tension-type headache according to the criteria of the International Headache Society were randomised into an experimental or a waiting list control group. Patients in the experimental group were treated 4 weeks in a hospital for traditional Chinese medicine after a baseline period of one month. Patients in the waiting list group continued their previous headache treatment. Main outcome measure was the difference in the number of days with headache of at least moderate intensity during baseline (month 1) and month 7. RESULTS: The difference in the number of days with headache of at least moderate intensity was 5.6 (S.D., 6.1) days in the experimental group and 1.2 (S.D., 4.5) days in the waiting list group (P <0.001). A reduction of more than 50% in headache days was observed in 52% of the patients in the experimental group and 16% in the waiting list group. Patients with migraine and a combination of migraine and episodic tension-type headaches improved more than patients with other headaches. CONCLUSION: The results of this study indicate that treatment in the hospital for traditional Chinese medicine in Kotzting is associated with lasting improvements in the majority of patients.