Michael Schuler

Patterns of care and course of symptoms in palliative radiotherapy: a multicenter pilot study analysis.

AbstractBackground and Purpose:To evaluate patterns of care as well as effectiveness and side effects of palliative treatment in four German radiation oncology departments.Patients and Methods:All referrals in four German radiation oncology departments (two university hospitals, one academic hospital, one private practice) were prospective documented for 1 month in 2008 (2 months at one of the university hospitals). In palliatively irradiated patients, treatment aims and indications as well as treated sites and fractionation schedules were recorded. In addition, symptoms and side effects were analyzed with standardized questionnaires before and at the end of radiotherapy.Results:During the observation period, 603 patients underwent radiation therapy in the four centers and 153 (24%, study popu-lation) were treated with palliative intent. Within the study, patients were most frequently treated for bone (34%) or brain (27%) metastases. 62 patients reported severe or very severe pain, 12 patients reported severe or very severe dyspnea, 27 patients reported neurological deficits or signs of cranial pressure, and 43 patients reported a poor or very poor sense of well-being. The most frequent goals were symptom relief (53%) or prevention of symptoms (46%). Life prolongation was intended in 37% of cases. A wide range of fractionation schedules was applied with total doses ranging from 3–61.2 Gy. Of the patients, 73% received a slightly hypofractionated treatment schedule with doses of > 2.0 Gy to ≤ 3.0 Gy per fraction and 12% received moderate to highly hypofractionated therapy with doses of > 3.0 Gy to 8.0 Gy. Radiation therapy led to a significant improvement of well-being (35% of patients) and reduction of symptoms, especially with regard to pain (66%), dyspnea (61%), and neurological deficits (60%). Therapy was very well tolerated with only 4.5% grade I or II acute toxicities being observed. Unscheduled termination was observed in 19 patients (12%).Conclusions:Palliative radiation therapy is effective in reducing symptoms, increases subjective well-being, and has minimal side effects. More studies are necessary for subgroup analyses and for clarifying the different goals in palliative radiotherapy.ZusammenfassungZiel:Evaluation der Alltagspraxis, des Symptomverlaufs und akuter Nebenwirkungen bei palliativer Strahlentherapie in vier strahlentherapeutischen Einrichtungen.Patienten und Methode:Alle Erstvorstellungen in den vier Einrichtungen (zwei Universitätskliniken, ein Lehrkrankenhaus und eine private Praxis) wurden einen Monat lang im Jahr 2008 prospektiv dokumentiert und ausgewertet (über 2 Monate in einer der Universitätskliniken). Bei den palliativ bestrahlten Patienten wurden die Indikationen, Behandlungsziele, die bestrahlten Regionen, die Therapiekonzepte und der Behandlungsverlauf dokumentiert. Klinische Symptome und akute Nebenwirkungen wurden zu Beginn und bei Abschluss der Strahlentherapie standardisiert erfasst.Ergebnisse:Im Beobachtungszeitraum erhielten 603 Patienten eine Strahlentherapie. 153 Patienten (24%) wurden unter palliativer Zielsetzung bestrahlt, zumeist wegen Knochenmetastasen (34%) oder Hirnmetastasen (27%). Die häufigsten Behandlungsziele waren Symptomlinderung (53%) oder die Prävention klinischer Beschwerden (46%). 66 Patienten berichteten über mittlere oder starke Schmerzen zu Beginn, 12 Patienten berichteten über mittlere oder starke Dyspnoe, 27 Patienten über mittlere oder starke neurologische Ausfälle bzw. Hirndrucksymptomatik, und 43 Patienten berichteten über weniger gutes oder schlechtes Wohlbefinden. In 37% zielte die Strahlentherapie auch auf Lebensverlängerung. Die applizierte Gesamtdosis betrug 3–61,2 Gy. 73% der Patienten wurden mäßig hypofraktioniert bestrahlt (Einzeldosen > 2,0 Gy bis ≤ 3,0 Gy), und 12% der Strahlentherapien wurden mit Einzeldosen > 3,0 Gy–8,0 Gy durchgeführt. Das Allgemeinbefinden war bei 34% der Patienten bei Abschluss der Strahlentherapie signifikant gebessert. 66% der Patienten berichteten eine signifikante Schmerzlinderung, bei 61% konnte Dys-pnoe signifikant gelindert werden, und bei 60% besserten sich neurologische Defizite oder Hirndrucksymptomatik. Die Behand-lung wurde mit 4,5% Grd-I- bis -II-Toxizitäten gut vertragen. 19 Behandlungen wurden vorzeitig abgebrochen (12%).Schlussfolgerungen:Die Alltagspraxis und der Symptomverlauf wurden erfolgreich in der Routine dokumentiert. Die palliative Strahlentherapie war gut verträglich, nebenwirkungsarm und wirksam in Bezug auf das Allgemeinbefinden und die Symptomlinderung. Für Subgruppenanalysen und zur Abgrenzung der verschiedenen Endpunkte palliativer Strahlentherapie sind weitere Untersuchungen mit größeren Fallzahlen erforderlich.

Patterns of Care and Course of Symptoms in Palliative Radiotherapy

AbstractBackground and Purpose:To evaluate patterns of care as well as effectiveness and side effects of palliative treatment in four German radiation oncology departments.Patients and Methods:All referrals in four German radiation oncology departments (two university hospitals, one academic hospital, one private practice) were prospective documented for 1 month in 2008 (2 months at one of the university hospitals). In palliatively irradiated patients, treatment aims and indications as well as treated sites and fractionation schedules were recorded. In addition, symptoms and side effects were analyzed with standardized questionnaires before and at the end of radiotherapy.Results:During the observation period, 603 patients underwent radiation therapy in the four centers and 153 (24%, study popu-lation) were treated with palliative intent. Within the study, patients were most frequently treated for bone (34%) or brain (27%) metastases. 62 patients reported severe or very severe pain, 12 patients reported severe or very severe dyspnea, 27 patients reported neurological deficits or signs of cranial pressure, and 43 patients reported a poor or very poor sense of well-being. The most frequent goals were symptom relief (53%) or prevention of symptoms (46%). Life prolongation was intended in 37% of cases. A wide range of fractionation schedules was applied with total doses ranging from 3–61.2 Gy. Of the patients, 73% received a slightly hypofractionated treatment schedule with doses of > 2.0 Gy to ≤ 3.0 Gy per fraction and 12% received moderate to highly hypofractionated therapy with doses of > 3.0 Gy to 8.0 Gy. Radiation therapy led to a significant improvement of well-being (35% of patients) and reduction of symptoms, especially with regard to pain (66%), dyspnea (61%), and neurological deficits (60%). Therapy was very well tolerated with only 4.5% grade I or II acute toxicities being observed. Unscheduled termination was observed in 19 patients (12%).Conclusions:Palliative radiation therapy is effective in reducing symptoms, increases subjective well-being, and has minimal side effects. More studies are necessary for subgroup analyses and for clarifying the different goals in palliative radiotherapy.ZusammenfassungZiel:Evaluation der Alltagspraxis, des Symptomverlaufs und akuter Nebenwirkungen bei palliativer Strahlentherapie in vier strahlentherapeutischen Einrichtungen.Patienten und Methode:Alle Erstvorstellungen in den vier Einrichtungen (zwei Universitätskliniken, ein Lehrkrankenhaus und eine private Praxis) wurden einen Monat lang im Jahr 2008 prospektiv dokumentiert und ausgewertet (über 2 Monate in einer der Universitätskliniken). Bei den palliativ bestrahlten Patienten wurden die Indikationen, Behandlungsziele, die bestrahlten Regionen, die Therapiekonzepte und der Behandlungsverlauf dokumentiert. Klinische Symptome und akute Nebenwirkungen wurden zu Beginn und bei Abschluss der Strahlentherapie standardisiert erfasst.Ergebnisse:Im Beobachtungszeitraum erhielten 603 Patienten eine Strahlentherapie. 153 Patienten (24%) wurden unter palliativer Zielsetzung bestrahlt, zumeist wegen Knochenmetastasen (34%) oder Hirnmetastasen (27%). Die häufigsten Behandlungsziele waren Symptomlinderung (53%) oder die Prävention klinischer Beschwerden (46%). 66 Patienten berichteten über mittlere oder starke Schmerzen zu Beginn, 12 Patienten berichteten über mittlere oder starke Dyspnoe, 27 Patienten über mittlere oder starke neurologische Ausfälle bzw. Hirndrucksymptomatik, und 43 Patienten berichteten über weniger gutes oder schlechtes Wohlbefinden. In 37% zielte die Strahlentherapie auch auf Lebensverlängerung. Die applizierte Gesamtdosis betrug 3–61,2 Gy. 73% der Patienten wurden mäßig hypofraktioniert bestrahlt (Einzeldosen > 2,0 Gy bis ≤ 3,0 Gy), und 12% der Strahlentherapien wurden mit Einzeldosen > 3,0 Gy–8,0 Gy durchgeführt. Das Allgemeinbefinden war bei 34% der Patienten bei Abschluss der Strahlentherapie signifikant gebessert. 66% der Patienten berichteten eine signifikante Schmerzlinderung, bei 61% konnte Dys-pnoe signifikant gelindert werden, und bei 60% besserten sich neurologische Defizite oder Hirndrucksymptomatik. Die Behand-lung wurde mit 4,5% Grd-I- bis -II-Toxizitäten gut vertragen. 19 Behandlungen wurden vorzeitig abgebrochen (12%).Schlussfolgerungen:Die Alltagspraxis und der Symptomverlauf wurden erfolgreich in der Routine dokumentiert. Die palliative Strahlentherapie war gut verträglich, nebenwirkungsarm und wirksam in Bezug auf das Allgemeinbefinden und die Symptomlinderung. Für Subgruppenanalysen und zur Abgrenzung der verschiedenen Endpunkte palliativer Strahlentherapie sind weitere Untersuchungen mit größeren Fallzahlen erforderlich.

A multicentre validation of the 1-min sit-to-stand test in patients with COPD.

Our aim was to comprehensively validate the 1-min sit-to-stand (STS) test in chronic obstructive pulmonary disease (COPD) patients and explore the physiological response to the test. We used data from two longitudinal studies of COPD patients who completed inpatient pulmonary rehabilitation programmes. We collected 1-min STS test, 6-min walk test (6MWT), health-related quality of life, dyspnoea and exercise cardiorespiratory data at admission and discharge. We assessed the learning effect, test–retest reliability, construct validity, responsiveness and minimal important difference of the 1-min STS test. In both studies (n=52 and n=203) the 1-min STS test was strongly correlated with the 6MWT at admission (r=0.59 and 0.64, respectively) and discharge (r=0.67 and 0.68, respectively). Intraclass correlation coefficients (95% CI) between 1-min STS tests were 0.93 (0.83–0.97) for learning effect and 0.99 (0.97–1.00) for reliability. Standardised response means (95% CI) were 0.87 (0.58–1.16) and 0.91 (0.78–1.07). The estimated minimal important difference was three repetitions. End-exercise oxygen consumption, carbon dioxide output, ventilation, breathing frequency and heart rate were similar in the 1-min STS test and 6MWT. The 1-min STS test is a reliable, valid and responsive test for measuring functional exercise capacity in COPD patients and elicited a physiological response comparable to that of the 6MWT. The 1-min STS test is a reliable, valid and responsive exercise capacity test in COPD with an MID of 3 repetitions http://ow.ly/teNx307ni0Q

Prostate cancer patients’ quality of life assessments across the primary treatment trajectory: ‘True’ change or response shift?

Abstract Background Self-report questionnaires are widely used to assess changes in quality of life (QoL) during the course of cancer treatment. However, comparing baseline scores to follow-up scores is only justified if patients’ internal measurement standards have not changed over time, that is, no response shift occurred. We aimed to examine response shift in terms of reconceptualization, reprioritization and recalibration among prostate cancer patients. Material and methods We included 402 newly diagnosed patients (mean age 65 years) and assessed QoL at the beginning of cancer treatment and three months later. QoL was measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). We employed structural equation modeling testing measurement invariance between occasions to disentangle ‘true’ change and change in the measurement model (response shift). Results We found reprioritization effects for both the Physical Functioning and Role Functioning subscales of the EORTC QLQ-C30, indicating that both had gained importance for representing the latent construct of QoL at follow-up. These effects added to the worsening effect evident in the latent construct, thus rendering observed changes even more pronounced. In addition, we found recalibration effects for both the Emotional Functioning and Cognitive Functioning subscales indicating judgments becoming more lenient over time. These effects counteracted ‘true’ negative changes thus obscuring any substantial changes on the observed level. Conclusion Our results suggest that changes observed in some subscales of the EORTC QLQ-C30 should not be taken at face value as they may be affected by patients’ changed measurement standards.

Inspiratory muscle training does not improve clinical outcomes in 3-week COPD rehabilitation: Results from a randomised controlled trial

The value of inspiratory muscle training (IMT) in pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) is unclear. The RIMTCORE (Routine Inspiratory Muscle Training within COPD Rehabilitation) randomised controlled trial examined the effectiveness of IMT added to pulmonary rehabilitation. In total, 611 COPD patients (Global Initiative for Chronic Obstructive Lung Disease stage II–IV) received a 3-week inpatient pulmonary rehabilitation, of which 602 patients were included in the intention-to-treat analyses. The intervention group (n=300) received highly intensive IMT and the control group (n=302) received sham IMT. The primary outcome was maximal inspiratory pressure (PImax). The secondary outcomes were 6-min walk distance, dyspnoea, quality of life and lung function. Outcomes were assessed pre- and post-pulmonary rehabilitation. ANCOVA was used. The intervention group showed higher effects in PImax (p<0.001) and forced inspiratory volume in 1 s (p=0.013). All other outcomes in both study groups improved significantly, but without further between-group differences. Sex and pulmonary rehabilitation admission shortly after hospitalisation modified quality of life effects. IMT as an add-on to a 3-week pulmonary rehabilitation improves inspiratory muscle strength, but does not provide additional benefits in terms of exercise capacity, quality of life or dyspnoea. A general recommendation for COPD patients to add IMT to a 3-week pulmonary rehabilitation cannot be made. IMT added to a 3-week PR programme improved PImax and FIV1, but not exercise capacity, dyspnoea or QoL #COPD http://ow.ly/hPGK30gfqej

Measurement invariance across chronic conditions: a systematic review and an empirical investigation of the Health Education Impact Questionnaire (heiQ™)

BackgroundTo examine whether lack of measurement invariance (MI) influences mean comparisons among different disease groups, this paper provides (1) a systematic review of MI in generic constructs across chronic conditions and (2) an empirical analysis of MI in the Health Education Impact Questionnaire (heiQ™).Methods(1) We searched for studies of MI among different chronic conditions in online databases. (2) Multigroup confirmatory factor analyses were used to study MI among five chronic conditions (orthopedic condition, rheumatism, asthma, COPD, cancer) in the heiQ™ with N = 1404 rehabilitation inpatients. Impact on latent and composite mean differences was examined.Results(1) A total of 30 relevant studies suggested that about one in three items lacked MI. However, only four studies examined impact on latent mean differences. Scale means were only affected in one of these three studies. (2) Across the eight heiQ™ scales, seven scales had items with lack of MI in at least one disease group. However, in only two heiQ™ scales were some latent or composite mean differences affected.ConclusionsLack of MI among disease groups is common and may have a relevant influence on mean comparisons when using generic instruments. Therefore, when comparing disease groups, tests of MI should be implemented. More studies of MI and according impact on mean differences in generic questionnaires are needed.

Health status instruments for patients with COPD in pulmonary rehabilitation : defining a minimal clinically important difference

The minimal clinically important difference (MCID) defines to what extent change on a health status instrument is clinically relevant, which aids scientists and physicians in measuring therapy effects. This is the first study that aimed to establish the MCID of the Clinical chronic obstructive pulmonary disease (COPD) Questionnaire (CCQ), the COPD Assessment Test (CAT) and the St George’s Respiratory Questionnaire (SGRQ) in the same pulmonary rehabilitation population using multiple approaches. In total, 451 COPD patients participated in a 3-week Pulmonary Rehabilitation (PR) programme (58 years, 65% male, 43 pack-years, GOLD stage II/III/IV 50/39/11%). Techniques used to assess the MCID were anchor-based approaches, including patient-referencing, criterion-referencing and questionnaire-referencing, and the distribution-based methods standard error of measurement (SEM), 1.96SEM and half standard deviation (0.5s.d.). Patient- and criterion-referencing led to MCID estimates of 0.56 and 0.62 (CCQ); 3.12 and 2.96 (CAT); and 8.40 and 9.28 (SGRQ). Questionnaire-referencing suggested MCID ranges of 0.28–0.61 (CCQ), 1.46–3.08 (CAT) and 6.86–9.47 (SGRQ). The SEM, 1.96SEM and 0.5s.d. were 0.29, 0.56 and 0.46 (CCQ); 3.28, 6.43 and 2.80 (CAT); 5.20, 10.19 and 6.06 (SGRQ). Pooled estimates were 0.52 (CCQ), 3.29 (CAT) and 7.91 (SGRQ) for improvement. MCID estimates differed depending on the method used. Pooled estimates suggest clinically relevant improvements needing to exceed 0.40 on the CCQ, 3.00 on the CAT and 7.00 on the SGRQ for moderate to very severe COPD patients. The MCIDs of the CAT and SGRQ in the literature might be too low, leading to overestimation of treatment effects for patients with COPD.

Effectiveness of pulmonary rehabilitation for patients with asthma: study protocol of a randomized controlled trial (EPRA)

BackgroundAsthma patients are enrolled in multimodal pulmonary rehabilitation (PR) programs. However, available data for the effectiveness of PR in asthma are sparse. Therefore, the primary aim of this randomized control trial (RCT) is to evaluate short-term (end of rehabilitation) and intermediate-term effectiveness (3 months after rehabilitation) of PR for patients with asthma regarding asthma control (primary outcome) and other outcomes. Secondly, moderator effects of gender, age, baseline asthma control, quality of life, and anxiety will be examined. Thirdly, a longitudinal follow-up study will explore the course of the outcomes over one year and the annual costs.MethodsThe EPRA study is a single-center randomized controlled waiting-list trial in the Bad Reichenhall Clinic. Inclusion criteria include a referral diagnosis for uncontrolled asthma, no cognitive impairment and no very severe co-morbidities that indicate significantly greater illness morbidity than asthma alone. In the intervention group (IG), participants will start PR within 4 weeks after randomization; participants of the control group (CG) will start PR 20 weeks after randomization. Data will be assessed at randomization (T0), after 4 weeks (T1; IG: begin of PR), 7 weeks (T2; IG: end of PR), and 20 weeks (T3, CG: begin of PR). The primary outcome is asthma control at T2/T3. Secondary outcomes are health-related quality of life, functional exercise capacity, dyspnea, anxiety, depression, subjective self-management skills, illness perceptions, sick leave and subjective work ability. Outcomes will be analyzed with analysis of covariance, including baseline values of the respective outcomes as covariates. Healthcare costs will be analyzed with a gamma model with a log-link.A longitudinal follow-up study will generate additional data at 3/6/9/12 months after PR for both IG and CG. Latent change models will be used to analyze the course of the primary and secondary outcomes. Annual cost differences before and after rehabilitation will be compared by paired t-test.DiscussionThis RCT will determine the effectiveness of a complex inpatient PR for asthma patients concerning asthma control. Furthermore, important medical and economic information regarding the effectiveness of PR as part of the long-term management of patients with uncontrolled asthma will be generated.Trial registrationGerman Clinical Trials Register (DRKS00007740, May 15, 2015). Protocol version: 1.0 (December, 23, 2016).

Asthma Control Test and Asthma Control Questionnaire: factorial validity, reliability and correspondence in assessing status and change in asthma control.

Abstract Objective: This study examined the factor structures and reliabilities of the Asthma Control Test (ACT) and the Asthma Control Questionnaire (ACQ-7; ACQ-6) and the correspondence between them in assessing both level and change in asthma control. Methods: Lung function and questionnaire data for ACT and ACQ were assessed in 113 asthma patients at the beginning (T1) and the end (T2) of inpatient rehabilitation. Confirmatory factor analyses, composite reliability coefficients, Pearson correlations, Cohen’s Kappa and positive/negative agreements were computed. Results: Unidimensional factor structure was confirmed for ACT. For ACQ configural invariance (i.e. same factor structure) over time could not be established. Furthermore, in ACQ-7, FEV1 showed no relation to the latent factor. Reliability estimates were 0.86–0.88 (ACT), 0.88–0.92(ACQ-6) and 0.81–0.86 (ACQ-7). Pearson correlations between ACT and ACQ were between 0.75 and 0.90 and tended to be higher at T2. If the aim is to identify patients with either not well-controlled asthma or change in asthma control, concordance was at least moderate (Kappa = 0.52–0.72). Correspondence tended to be lower in identifying patients with well-controlled asthma (Kappa = 0.30–0.79). In some circumstances, ACQ-6 showed higher agreement with ACT than did ACQ-7. Conclusions: ACT is a unidimensional measure, but factor structure of ACQ remains unclear. Correspondence between ACT and ACQ depends on the aim of the assessment. Including FEV1 in the assessment of asthma control level even lowers reliability of ACQ and concordance with ACT. Our results support GINA (2014) in conceptualizing FEV1 as a risk factor for poor asthma outcome instead of an indicator of level of asthma control.

Messen wir bei allen Personen das Gleiche? Zur Invarianz von Messungen und Response Shift in der Rehabilitation – Teil 1

Subjective constructs like health-related quality of life are often investigated in scientific surveys in rehabilitation science, usually assuming that such constructs would be equally defined between different groups in case of cross-sectional control group designs or across time in longitudinal study designs with or without control-groups. Differences between measurements of these constructs were expected to occur only regarding quantity but not regarding quality. However, this assumption cannot be expected to apply in every case and it is discussed from a theoretical angle under the terms of invariance or equivalence of measurements. Confirmatory factor analysis-based approaches are suitable to investigate measurement invariance empirically and will be described in this article. These statistical methods are applicable to test whether qualitative differences in constructs exist between several groups or time points (response shift) and what these differences mean. If measurement invariance cannot be held, comparisons of sum scores, which are often used in rehabilitation science, have to be considered to be questionable. On the basis of a measurement model specific parameters (regression weights, intercepts, measurement errors) can be analyzed both between comparison groups and over time. Different kinds of measurement invariance exist, depending on the statistical definition of parameters which are proven to be equal, and the extent of differences between models. The application of confirmatory factor analysis to test measurement invariance in a cross-sectional design will be described in this article on the example of quality of life data from inpatient rehabilitation. Methodological and substantive aspects which arise if measurement invariance is disproved will be discussed. In a companion article (Jelitte & Schuler, in press) the method will be described for a longitudinal study design and results will be discussed in the context of response shift research.