The effects of a nurse-managed secondary prevention program for patients after acute cardiac even... more The effects of a nurse-managed secondary prevention program for patients after acute cardiac events were examined. Special interest was given to gender-specific results. The design was a prospective, randomized, controlled trial involving 343 patients following 3 weeks of inpatient cardiac rehabilitation, randomly assigned to either of two study groups. Patients in the treatment group were contacted monthly by phone over 1 year. The main goals of the intervention were the reduction of behavioural coronary risk factors and enhancing quality of life. The program was conducted by specially trained nurses. The control group received written information only. Primary outcome was the Framingham risk score. Follow-up examination after 12 months was completed by 297 patients. Patients in the intervention group showed lower Framingham risk scores as compared to controls. Separate analyses by sex revealed that this was mostly due to the men in the sample. Women, on the other hand, showed a significant rise of clinically relevant anxiety/depressiveness in the control but not in the intervention group; in males there were no differences between study conditions. In conclusion, telephone counselling by specially trained nurses seems a cost-effective way to achieve a lasting reduction in cardiac risk factors and to maintain the effects of cardiac rehabilitation.
Journal of Epidemiology and Community …, Jan 1, 1994
Objective -To review a series ofconceptual and methodological problems encountered in surveys pri... more Objective -To review a series ofconceptual and methodological problems encountered in surveys primarily devoted to pain disorders. Criteriafor inclusion and exclusion ofarticles -Published reports were systematically collected by electronic database searches (Medline), citations in existing publications, and through personal contacts. Relevant articles from clinical and epidemiological research on pain were included and special attention was given to epidemiological research on back pain.
Cross-sectional survey with personal interviews. To study national differences in subjective heal... more Cross-sectional survey with personal interviews. To study national differences in subjective health, back pain, and self-perceived disability between the United Kingdom and Germany. Back pain is a leading health problem in most Western populations, causing enormous costs to the national health systems. Different prevalence rates were reported from many countries, but rarely as a result of a direct comparison based on an identical study design. A total of 6,235 male and female participants 50 to 79 years of age (population-based stratified random samples) were recruited in 6 British and 8 German study centers. The interviewer administered standardized questionnaire included a section about presence and severity of back pain. Past and current back pain was more frequent among German participants and different between East and West German centers. The differences in back pain prevalence rates could not be explained by less favorable risk profiles among German respondents. Intercultural differences in perceiving or reporting back pain can be hypothesized as the most likely explanation of the markedly different prevalence rates of the disorder in the United Kingdom and East and West Germany.
... leaving school after 8 to 9 years at the age of 14 or 15), intermediate (Mittlere Reife/ Fach... more ... leaving school after 8 to 9 years at the age of 14 or 15), intermediate (Mittlere Reife/ Fachhochschulreife: certificate after 10 to 12 years of school at the age of 16 or 18), high (Abitur:certificate after 13 years of school at the age of 19). Low level of education was chosen as the ...
Objectives: To develop European League Against Rheumatism (EULAR) recommendations for the managem... more Objectives: To develop European League Against Rheumatism (EULAR) recommendations for the management of large vessel vasculitis. Methods: An expert group (10 rheumatologists, 3 nephrologists, 2 immunolgists, 2 internists representing 8 European countries and the USA, a clinical epidemiologist and a representative from a drug regulatory agency) identified 10 topics for a systematic literature search through a modified Delphi technique. In accordance with standardised EULAR operating procedures, recommendations were derived for the management of large vessel vasculitis. In the absence of evidence, recommendations were formulated on the basis of a consensus opinion. Results: Seven recommendations were made relating to the assessment, investigation and treatment of patients with large vessel vasculitis. The strength of recommendations was restricted by the low level of evidence and EULAR standardised operating procedures. Conclusions: On the basis of evidence and expert consensus, management recommendations for large vessel vasculitis have been formulated and are commended for use in everyday clinical practice.
Objectives: We undertook a systematic literature review as a background to the European League Ag... more Objectives: We undertook a systematic literature review as a background to the European League Against Rheumatism (EULAR) recommendations for conducting clinical trials in anti-neutrophil cytoplasm antibody associated vasculitis (AAV), and to assess the quality of evidence for outcome measures in AAV. Methods: Using a systematic Medline search, we categorised the identified studies according to diagnoses. Factors affecting remission, relapse, renal function and overall survival were identified. Results: A total of 44 papers were reviewed from 502 identified by our search criteria. There was considerable inconsistency in definitions of end points. Remission rates varied from 30% to 93% in Wegener granulomatosis (WG), 75% to 89% in microscopic polyangiitis (MPA) and 81% to 91% in Churg-Strauss syndrome (CSS). The 5year survival for WG, MPA and CSS was 74-91%, 45-76% and 60-97%. Relapse (variably defined) was common in the first 2 years but the frequency varied: 18% to 60% in WG, 8% in MPA, and 35% in CSS. The rate of renal survival in WG varied from 23% at 15 months to 23% at 120 months. Methods used to assess morbidity varied between studies. Ignoring the variations in definitions of the stage of disease, factors influencing remission, relapse, renal and overall survival included immunosuppressive therapy used, type of organ involvement, presence of ANCA, older age and male gender. Conclusions: Factors influencing remission, relapse, renal and overall survival include the type of immunosuppressive therapy used, pattern of organ involvement, presence of ANCA, older age and male gender. Methodological variations between studies highlight the need for a consensus on terminology and definitions for future conduct of clinical studies in AAV.
A cross-sectional population-based study of back pain. To evaluate the association between clinic... more A cross-sectional population-based study of back pain. To evaluate the association between clinical findings on physical examination and subjective severity in nonspecific back pain. Assessment of severity of back pain always has been controversial. Most studies evaluating the role of clinical findings in back pain have been hospital- or clinic-based, often representing a highly select population. This selection is avoided in the population-based approach of the present study. Approximately 4,000 German inhabitants of Lubeck, aged 25-74, were selected randomly from the local population registry and received a postal questionnaire. Those who reported "back pain today" (n = 1200) or "back pain within the past 12 months but no back pain before" (n = 75) were invited to come in for a clinical examination. Thirty-four physical measurements were taken. They were divided into four groups: static measurements, dynamic measurements, neurologic findings, and non-organic physical signs. Self-reported severity of back pain was measured by a pain questionnaire and a 12-item activities of daily living list to assess functional disability. Within each of the four groups of physical measurements, those that corresponded best with the subjective severity of back pain could be identified (e.g., rotation, lateral flexion, and fingertip-floor distance, scoliosis, the position of the side plumb line, and pain on percussion of the spine pseudo-Lasegue and hand muscle-strength). Those that corresponded best could be differentiated statistically from less correlative measurements such as kyphosis and lordosis; flexion of the lumbar, thoracic, or cervical spine, abdominal muscle strength, and axial loading. The agreement between the classification of back pain severity based on clinical findings and the classification based on self-reports was moderate (kappa = 0.47). Assessment of severity in back pain can only partly be based on the clinical findings of a physical examination. There is a relatively weak agreement between the results of physical examination and the subjective reporting of pain and disability.
A population-based cross-sectional multiregion postal survey. To provide a descriptive epidemiolo... more A population-based cross-sectional multiregion postal survey. To provide a descriptive epidemiology of the prevalence and severity of back pain in German adults and to analyze sociodemographic correlates for disabling back pain within and across regions. Back pain is a leading health problem in Germany. However, comprehensive population-based evidence on the severity of back pain is still fragmentary for this country. Despite earlier findings concerning large prevalence differences across regions, systematic explanations remain to be ascertained. Questionnaire data were collected for 9263 subjects in 5 German cities and regions (population-based random samples, postal questionnaire). Point, 1-year, and lifetime prevalence were assessed using direct questions, and graded back pain was determined using the Graded Chronic Pain Scale. Poststratification was applied to adjust for cross-regional sociodemographic differences. Point-prevalence was 37.1%, 1-year prevalence 76.0%, and lifetime prevalence 85.5%. A substantial minority had severe (Grade II, 8.0%) or disabling back pain (Grade III-IV, 11.2%). Subjects with a low educational level reported substantially more disabling back pain. This variable was an important predictor for large cross-regional differences in the burden of back pain. Back pain is a highly prevalent condition in Germany. Disabling back pain in this country may be regarded as part of a social disadvantage syndrome. Educational level should receive greater attention in future cross-regional comparisons of back pain.
ObjectivesTo develop the European League Against Rheumatism (EULAR) recommendations for conductin... more ObjectivesTo develop the European League Against Rheumatism (EULAR) recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis.MethodsAn expert consensus group was formed consisting of rheumatologists, nephrologists and specialists in internal medicine representing five European countries and the USA, a clinical epidemiologist and representatives from regulatory agencies. Using an evidence‐based and expert opinion‐based approach in accordance with the standardised EULAR operating procedures, the group identified nine topics for a systematic literature search through a modified Delphi technique. On the basis of research questions posed by the group, recommendations were derived for conducting clinical studies and/or clinical trials in systemic vasculitis.ResultsBased on the results of the literature research, the expert committee concluded that sufficient evidence to formulate guidelines on conducting clinical trials was available only for anti‐neutrophil cytoplasm antibody‐associated vasculitides (AAV). It was therefore decided to focus the recommendations on these diseases. Recommendations for conducting clinical trials in AAV were elaborated and are presented in this summary document. It was decided to consider vasculitis‐specific issues rather than general issues of trial methodology. The recommendations deal with the following areas related to clinical studies of vasculitis: definitions of disease, activity states, outcome measures, eligibility criteria, trial design including relevant end points, and biomarkers. A number of aspects of trial methodology were deemed important for future research.ConclusionsOn the basis of expert opinion, recommendations for conducting clinical trials in AAV were formulated. Furthermore, the expert committee identified a strong need for well‐designed research in non‐AAV systemic vasculitides.
Objectives: To develop European League Against Rheumatism (EULAR) recommendations for the managem... more Objectives: To develop European League Against Rheumatism (EULAR) recommendations for the management of small and medium vessel vasculitis. Methods: An expert group (consisting of 10 rheumatologists, 3 nephrologists, 2 immunologists, 2 internists representing 8 European countries and the USA, a clinical epidemiologist and a representative from a drug regulatory agency) identified 10 topics for a systematic literature search using a modified Delphi technique. In accordance with standardised EULAR operating procedures, recommendations were derived for the management of small and medium vessel vasculitis. In the absence of evidence, recommendations were formulated on the basis of a consensus opinion. Results: In all, 15 recommendations were made for the management of small and medium vessel vasculitis. The strength of recommendations was restricted by low quality of evidence and by EULAR standardised operating procedures. Conclusions: On the basis of evidence and expert consensus, recommendations have been made for the evaluation, investigation, treatment and monitoring of patients with small and medium vessel vasculitis for use in everyday clinical practice.
The effects of a nurse-managed secondary prevention program for patients after acute cardiac even... more The effects of a nurse-managed secondary prevention program for patients after acute cardiac events were examined. Special interest was given to gender-specific results. The design was a prospective, randomized, controlled trial involving 343 patients following 3 weeks of inpatient cardiac rehabilitation, randomly assigned to either of two study groups. Patients in the treatment group were contacted monthly by phone over 1 year. The main goals of the intervention were the reduction of behavioural coronary risk factors and enhancing quality of life. The program was conducted by specially trained nurses. The control group received written information only. Primary outcome was the Framingham risk score. Follow-up examination after 12 months was completed by 297 patients. Patients in the intervention group showed lower Framingham risk scores as compared to controls. Separate analyses by sex revealed that this was mostly due to the men in the sample. Women, on the other hand, showed a significant rise of clinically relevant anxiety/depressiveness in the control but not in the intervention group; in males there were no differences between study conditions. In conclusion, telephone counselling by specially trained nurses seems a cost-effective way to achieve a lasting reduction in cardiac risk factors and to maintain the effects of cardiac rehabilitation.
Journal of Epidemiology and Community …, Jan 1, 1994
Objective -To review a series ofconceptual and methodological problems encountered in surveys pri... more Objective -To review a series ofconceptual and methodological problems encountered in surveys primarily devoted to pain disorders. Criteriafor inclusion and exclusion ofarticles -Published reports were systematically collected by electronic database searches (Medline), citations in existing publications, and through personal contacts. Relevant articles from clinical and epidemiological research on pain were included and special attention was given to epidemiological research on back pain.
Cross-sectional survey with personal interviews. To study national differences in subjective heal... more Cross-sectional survey with personal interviews. To study national differences in subjective health, back pain, and self-perceived disability between the United Kingdom and Germany. Back pain is a leading health problem in most Western populations, causing enormous costs to the national health systems. Different prevalence rates were reported from many countries, but rarely as a result of a direct comparison based on an identical study design. A total of 6,235 male and female participants 50 to 79 years of age (population-based stratified random samples) were recruited in 6 British and 8 German study centers. The interviewer administered standardized questionnaire included a section about presence and severity of back pain. Past and current back pain was more frequent among German participants and different between East and West German centers. The differences in back pain prevalence rates could not be explained by less favorable risk profiles among German respondents. Intercultural differences in perceiving or reporting back pain can be hypothesized as the most likely explanation of the markedly different prevalence rates of the disorder in the United Kingdom and East and West Germany.
... leaving school after 8 to 9 years at the age of 14 or 15), intermediate (Mittlere Reife/ Fach... more ... leaving school after 8 to 9 years at the age of 14 or 15), intermediate (Mittlere Reife/ Fachhochschulreife: certificate after 10 to 12 years of school at the age of 16 or 18), high (Abitur:certificate after 13 years of school at the age of 19). Low level of education was chosen as the ...
Objectives: To develop European League Against Rheumatism (EULAR) recommendations for the managem... more Objectives: To develop European League Against Rheumatism (EULAR) recommendations for the management of large vessel vasculitis. Methods: An expert group (10 rheumatologists, 3 nephrologists, 2 immunolgists, 2 internists representing 8 European countries and the USA, a clinical epidemiologist and a representative from a drug regulatory agency) identified 10 topics for a systematic literature search through a modified Delphi technique. In accordance with standardised EULAR operating procedures, recommendations were derived for the management of large vessel vasculitis. In the absence of evidence, recommendations were formulated on the basis of a consensus opinion. Results: Seven recommendations were made relating to the assessment, investigation and treatment of patients with large vessel vasculitis. The strength of recommendations was restricted by the low level of evidence and EULAR standardised operating procedures. Conclusions: On the basis of evidence and expert consensus, management recommendations for large vessel vasculitis have been formulated and are commended for use in everyday clinical practice.
Objectives: We undertook a systematic literature review as a background to the European League Ag... more Objectives: We undertook a systematic literature review as a background to the European League Against Rheumatism (EULAR) recommendations for conducting clinical trials in anti-neutrophil cytoplasm antibody associated vasculitis (AAV), and to assess the quality of evidence for outcome measures in AAV. Methods: Using a systematic Medline search, we categorised the identified studies according to diagnoses. Factors affecting remission, relapse, renal function and overall survival were identified. Results: A total of 44 papers were reviewed from 502 identified by our search criteria. There was considerable inconsistency in definitions of end points. Remission rates varied from 30% to 93% in Wegener granulomatosis (WG), 75% to 89% in microscopic polyangiitis (MPA) and 81% to 91% in Churg-Strauss syndrome (CSS). The 5year survival for WG, MPA and CSS was 74-91%, 45-76% and 60-97%. Relapse (variably defined) was common in the first 2 years but the frequency varied: 18% to 60% in WG, 8% in MPA, and 35% in CSS. The rate of renal survival in WG varied from 23% at 15 months to 23% at 120 months. Methods used to assess morbidity varied between studies. Ignoring the variations in definitions of the stage of disease, factors influencing remission, relapse, renal and overall survival included immunosuppressive therapy used, type of organ involvement, presence of ANCA, older age and male gender. Conclusions: Factors influencing remission, relapse, renal and overall survival include the type of immunosuppressive therapy used, pattern of organ involvement, presence of ANCA, older age and male gender. Methodological variations between studies highlight the need for a consensus on terminology and definitions for future conduct of clinical studies in AAV.
A cross-sectional population-based study of back pain. To evaluate the association between clinic... more A cross-sectional population-based study of back pain. To evaluate the association between clinical findings on physical examination and subjective severity in nonspecific back pain. Assessment of severity of back pain always has been controversial. Most studies evaluating the role of clinical findings in back pain have been hospital- or clinic-based, often representing a highly select population. This selection is avoided in the population-based approach of the present study. Approximately 4,000 German inhabitants of Lubeck, aged 25-74, were selected randomly from the local population registry and received a postal questionnaire. Those who reported "back pain today" (n = 1200) or "back pain within the past 12 months but no back pain before" (n = 75) were invited to come in for a clinical examination. Thirty-four physical measurements were taken. They were divided into four groups: static measurements, dynamic measurements, neurologic findings, and non-organic physical signs. Self-reported severity of back pain was measured by a pain questionnaire and a 12-item activities of daily living list to assess functional disability. Within each of the four groups of physical measurements, those that corresponded best with the subjective severity of back pain could be identified (e.g., rotation, lateral flexion, and fingertip-floor distance, scoliosis, the position of the side plumb line, and pain on percussion of the spine pseudo-Lasegue and hand muscle-strength). Those that corresponded best could be differentiated statistically from less correlative measurements such as kyphosis and lordosis; flexion of the lumbar, thoracic, or cervical spine, abdominal muscle strength, and axial loading. The agreement between the classification of back pain severity based on clinical findings and the classification based on self-reports was moderate (kappa = 0.47). Assessment of severity in back pain can only partly be based on the clinical findings of a physical examination. There is a relatively weak agreement between the results of physical examination and the subjective reporting of pain and disability.
A population-based cross-sectional multiregion postal survey. To provide a descriptive epidemiolo... more A population-based cross-sectional multiregion postal survey. To provide a descriptive epidemiology of the prevalence and severity of back pain in German adults and to analyze sociodemographic correlates for disabling back pain within and across regions. Back pain is a leading health problem in Germany. However, comprehensive population-based evidence on the severity of back pain is still fragmentary for this country. Despite earlier findings concerning large prevalence differences across regions, systematic explanations remain to be ascertained. Questionnaire data were collected for 9263 subjects in 5 German cities and regions (population-based random samples, postal questionnaire). Point, 1-year, and lifetime prevalence were assessed using direct questions, and graded back pain was determined using the Graded Chronic Pain Scale. Poststratification was applied to adjust for cross-regional sociodemographic differences. Point-prevalence was 37.1%, 1-year prevalence 76.0%, and lifetime prevalence 85.5%. A substantial minority had severe (Grade II, 8.0%) or disabling back pain (Grade III-IV, 11.2%). Subjects with a low educational level reported substantially more disabling back pain. This variable was an important predictor for large cross-regional differences in the burden of back pain. Back pain is a highly prevalent condition in Germany. Disabling back pain in this country may be regarded as part of a social disadvantage syndrome. Educational level should receive greater attention in future cross-regional comparisons of back pain.
ObjectivesTo develop the European League Against Rheumatism (EULAR) recommendations for conductin... more ObjectivesTo develop the European League Against Rheumatism (EULAR) recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis.MethodsAn expert consensus group was formed consisting of rheumatologists, nephrologists and specialists in internal medicine representing five European countries and the USA, a clinical epidemiologist and representatives from regulatory agencies. Using an evidence‐based and expert opinion‐based approach in accordance with the standardised EULAR operating procedures, the group identified nine topics for a systematic literature search through a modified Delphi technique. On the basis of research questions posed by the group, recommendations were derived for conducting clinical studies and/or clinical trials in systemic vasculitis.ResultsBased on the results of the literature research, the expert committee concluded that sufficient evidence to formulate guidelines on conducting clinical trials was available only for anti‐neutrophil cytoplasm antibody‐associated vasculitides (AAV). It was therefore decided to focus the recommendations on these diseases. Recommendations for conducting clinical trials in AAV were elaborated and are presented in this summary document. It was decided to consider vasculitis‐specific issues rather than general issues of trial methodology. The recommendations deal with the following areas related to clinical studies of vasculitis: definitions of disease, activity states, outcome measures, eligibility criteria, trial design including relevant end points, and biomarkers. A number of aspects of trial methodology were deemed important for future research.ConclusionsOn the basis of expert opinion, recommendations for conducting clinical trials in AAV were formulated. Furthermore, the expert committee identified a strong need for well‐designed research in non‐AAV systemic vasculitides.
Objectives: To develop European League Against Rheumatism (EULAR) recommendations for the managem... more Objectives: To develop European League Against Rheumatism (EULAR) recommendations for the management of small and medium vessel vasculitis. Methods: An expert group (consisting of 10 rheumatologists, 3 nephrologists, 2 immunologists, 2 internists representing 8 European countries and the USA, a clinical epidemiologist and a representative from a drug regulatory agency) identified 10 topics for a systematic literature search using a modified Delphi technique. In accordance with standardised EULAR operating procedures, recommendations were derived for the management of small and medium vessel vasculitis. In the absence of evidence, recommendations were formulated on the basis of a consensus opinion. Results: In all, 15 recommendations were made for the management of small and medium vessel vasculitis. The strength of recommendations was restricted by low quality of evidence and by EULAR standardised operating procedures. Conclusions: On the basis of evidence and expert consensus, recommendations have been made for the evaluation, investigation, treatment and monitoring of patients with small and medium vessel vasculitis for use in everyday clinical practice.
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Papers by Heiner Raspe