TY - JOUR A1 - Riemer, Manuel A1 - Kranke, Peter A1 - Helf, Antonia A1 - Mayer, Debora A1 - Popp, Maria A1 - Schlesinger, Tobias A1 - Meybohm, Patrick A1 - Weibel, Stephanie T1 - Trial registration and selective outcome reporting in 585 clinical trials investigating drugs for prevention of postoperative nausea and vomiting JF - BMC Anesthesiology N2 - Background: Selective outcome reporting in clinical trials introduces bias in the body of evidence distorting clinical decision making. Trial registration aims to prevent this bias and is suggested by the International Committee of Medical Journal Editors (ICMJE) since 2004. Methods: The 585 randomized controlled trials (RCTs) published between 1965 and 2017 that were included in a recently published Cochrane review on antiemetic drugs for prevention of postoperative nausea and vomiting were selected. In a retrospective study, we assessed trial registration and selective outcome reporting by comparing study publications with their registered protocols according to the ‘Cochrane Risk of bias’ assessment tool 1.0. Results: In the Cochrane review, the first study which referred to a registered trial protocol was published in 2004. Of all 585 trials included in the Cochrane review, 334 RCTs were published in 2004 or later, of which only 22% (75/334) were registered. Among the registered trials, 36% (27/75) were pro- and 64% (48/75) were retrospectively registered. 41% (11/27) of the prospectively registered trials were free of selective outcome reporting bias, 22% (6/27) were incompletely registered and assessed as unclear risk, and 37% (10/27) were assessed as high risk. Major outcome discrepancies between registered and published high risk trials were a change from the registered primary to a published secondary outcome (32%), a new primary outcome (26%), and different outcome assessment times (26%). Among trials with high risk of selective outcome reporting 80% favoured at least one statistically significant result. Registered trials were assessed more often as ‘overall low risk of bias’ compared to non-registered trials (64% vs 28%). Conclusions: In 2017, 13 years after the ICMJE declared prospective protocol registration a necessity for reliable clinical studies, the frequency and quality of trial registration in the field of PONV is very poor. Selective outcome reporting reduces trustworthiness in findings of clinical trials. Investigators and clinicians should be aware that only following a properly registered protocol and transparently reporting of predefined outcomes, regardless of the direction and significance of the result, will ultimately strengthen the body of evidence in the field of PONV research in the future. KW - clinical trial KW - postoperative nausea and vomiting KW - selective outcome reporting KW - systematic review KW - trial registration Y1 - 2021 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-265518 VL - 21 ER - TY - THES A1 - Held, Helena T1 - The effectiveness of non-occlusal therapies in relation to the chronicity of temporomandibular disorders: a systematic review with meta-analysis T1 - Die Effektivität von nicht-okklusalen Therapien in Bezug auf die Chronifizierung von Craniomandibulärer Dysfunktionen: eine Systematische Übersichtsarbeit mit Metaanalyse N2 - Background: That a differentiated treatment of subjects with low and high levels of disabling pain might be necessarily has only been suspected but not sufficiently confirmed so far. Furthermore, the effectiveness of extraoral therapy methods for TMD is still controversial in the literature. The present work could make an important contribution to this. Objectives: Five systematic reviews with meta-analysis were conducted to investigate the efficacy of extraoral therapies (acupuncture, laser, medication, psychosocial interventions, and physiotherapy) in the treatment of TMD in relation to the degree of chronicity of pain. Literature sources: With this objective, the databases Pubmed/MEDLINE, EMBASE, Cochrane Library, Livivo, OpenGrey, drks.de, Clinicaltrials.gov. were searched. Criteria for the selection of suitable studies: Adults suffering from painful TMD and treated with either acupuncture, laser, medication, psychosocial interventions, or physiotherapy. The studies were then examined for evidence in the subjects' characteristics suggesting that they were suffering from chronic TMD in terms of pain dysfunction. These included a high score on the GCPS, resistance to undergone treatments, multilocular pain, depression, and regular use of pain medication. The effectiveness of the five interventions was then differentiated according to the suspected degree of chronicity. Effectiveness was assessed by the following outcomes: patient- related current pain intensity, MMO, pain on palpation, temporomandibular joint sounds, depression, and somatization. Study evaluation: After the assessment of the studies, the quality assessment (Risk of Bias Tool of the Cochrane Institute) and the extraction of the data were conducted. After that five meta-analyses were carried out for each of the five interventions using the Review Manager of the Cochrane Institute (RevMan 5.3) Results: Acupuncture and dry needling were statistically significantly more effective in providing short-term pain relief compared to the control group in patients with low disability pain (p=0.04) and (p=0.02), respectively. Acupuncture or dry needling did not show a significant result in the improvement of MMO in the short-term period. Laser therapy is more effective in relieving pain (p<0.0001) and functional outcomes (p=0.03) in the short term compared to placebo for low disability pain. Botulinum toxin (p=0.003) and NSAIDs (p=0.03) showed significantly better short-term improvement in pain intensity for high disability pain. Low disability pain is significantly better treated by psychosocial interventions than by other treatments in terms of long-term pain relief (more than 12 months) (p=0.02). Patients with high disability pain had significantly lower depression scores after psychosocial interventions than after other treatments (p=0.008). Physiotherapy showed a statistically significant short-term analgesic effect in patients with high disability pain compared to placebo (p=0.04). Manual Therapy (MT) showed a statistically significant short-term analgesic effect in high disability pain compared to the control group (p=0.01). Patients with low disability pain showed a statistically significant short-term pain-relieving effect with the single intervention of MT in combination with exercise compared to the control groups (p=0.003). A statistically significant result in the improvement of MMO was found in the short-term period in low disability pain for the single interventions of physiotherapy (p=0.008) and physiotherapy in combination with another treatment compared to other treatments (p=0.03), MT compared to the control group (p=0.03) and physiotherapy compared to splint therapy (p=0.03). Clinical conclusion: Individual interventions of the five extraoral therapies confirm the hypothesis that painful TMDs respond differently to established therapies depending on the degree of chronic pain-related disability and that the prognosis of therapy is significantly influenced by the degree of chronic pain- related disability of the condition, according to the GCPS. Registration number of the review at PROSPERO: CRD42020202558 Keywords: meta-analysis, systematic review, temporomandibular disorders, extra oral therapy, acupuncture, laser, medication, psychosocial interventions, physiotherapy, low disability, high disability, pain, chronification N2 - Hintergrund: Das eine differenzierte Behandlung von Probanden mit funktionalem (fS) und dysfunktionalem Schmerz (dS) notwendig sein könnte, wurde bisher nur vermutet, aber nicht ausreichend bestätigt. Darüber hinaus ist die Wirksamkeit extraoraler Therapiemethoden bei CMD in der Literatur noch umstritten. Die vorliegende Arbeit könnte hierzu einen wichtigen Beitrag leisten. Ziele: Fünf systematische Übersichten mit Metaanalyse wurden durchgeführt, um die Wirksamkeit extraoraler Therapien (Akupunktur, Laser, Medikamente, psychosoziale Interventionen und Physiotherapie) bei der Behandlung von einer schmerzhaften CMD in Abhängigkeit von dem Chronifizierungsgrad zu untersuchen. Literaturquellen: Die Datenbanken Pubmed/MEDLINE, EMBASE, Cochrane Library, Livivo, OpenGrey, drks.de und Clinicaltrials.gov wurden durchsucht. Auswahlkriterien: Erwachsene PatientInnen, die an schmerzhaften CMD leiden und entweder mit Akupunktur, Laser, Medikamenten, psychosoziale Interventionen oder Physiotherapie behandelt wurden. Die Studien wurden dann auf Hinweise in den Probandenmerkmalen untersucht, die darauf schließen lassen, dass die ProbandInnen unter chronischer CMD im Sinne einer Schmerzdysfunktion leiden. Dazu gehörten ein hoher Wert im GCPS, Behandlungen, die die Probanden bereits erfolglos durchgeführt hatten, multilokuläre Schmerzen, Depressionen und regelmäßige Einnahme von Schmerzmitteln. Anschließend wurde die Wirksamkeit der fünf Interventionen nach dem vermuteten Grad der Chronifizierung differenziert. Die Wirksamkeit wurde anhand der folgenden Ergebnisse untersucht: patientenbezogene aktuelle Schmerzintensität, MMO, Schmerz bei Palpation, Kiefergelenkgeräusche, Depression und Somatisierung. Studienbewertung: Nach der Bewertung der Studien, der Qualitätsbeurteilung (Risk of Bias Tool des Cochrane-Instituts) und der Extraktion der Daten wurden für jede der fünf Interventionen fünf Meta-Analysen mit dem Review Manager des Cochrane-Instituts (RevMan 5.3) durchgeführt Ergebnisse: Akupunktur und Dry Needling waren statistisch signifikant wirksamer bei der kurzfristigen Schmerzlinderung im Vergleich zur Kontrollgruppe bei Patienten mit geringem Grad an beeinträchtigendem Schmerz (p=0,04) bzw. (p=0,02). Akupunktur oder Dry-Needling zeigten im kurzfristigen Zeitraum kein statistisch signifikantes Ergebnis in der Verbesserung der Kieferöffnung. Die Lasertherapie ist im Vergleich zu Placebo bei funktionalem Schmerz kurzfristig wirksamer bei der Reduktion der Schmerzintensität (p<0,0001) und funktionellen Ergebnissen (p=0,03). Botulinumtoxin (p=0,003) und NSARs (p=0,03) zeigten eine signifikant bessere kurzfristige Verbesserung der Schmerzintensität bei dS. FS werden durch die psychosozialen Interventionen signifikant besser behandelt als durch andere Behandlungen, was die langfristige Schmerzlinderung (mehr als 12 Monate) betrifft (p=0,02). PatientInnen mit dS wiesen nach psychosozialen Interventionen signifikant niedrigere Depressionswerte auf als nach anderen Behandlungen (p=0.008). Physiotherapie zeigte eine statistisch signifikante kurzfristige schmerzlindernde Wirkung bei PatientInnen mit dS im Vergleich zu Placebo (p=0,04). Manuelle Therapie (MT) zeigte eine statistisch signifikante kurzfristige schmerzlindernde Wirkung bei dS im Vergleich zur Kontrollgruppe (p=0,01). Bei PatientInnen mit fS zeigte sich im Vergleich zu den Kontrollgruppen eine statistisch signifikante kurzfristige schmerzlindernde Wirkung bei der Einzelintervention von MT in Kombination mit Bewegung (p=0,003). Ein statistisch signifikantes Ergebnis bei der Verbesserung der MMO wurde im Kurzzeitzeitraum bei fS für die Einzelinterventionen der Physiotherapie (p=0,008) und der Physiotherapie in Kombination mit einer anderen Behandlung im Vergleich zu anderen Behandlungen (p=0,03), der MT im Vergleich zur Kontrollgruppe (p=0,03) und der Physiotherapie im Vergleich zur Schienentherapie festgestellt (p=0,03). Schlussfolgerung: Einzelne Interventionen der fünf extraoralen Therapien bestätigen die Hypothese, dass schmerzhafte CMD je nach Grad der Schmerz Chronifizierung unterschiedlich auf etablierte Therapien ansprechen und dass die Prognose der Therapie signifikant durch den Grad der Chronifizierung der Erkrankung beeinflusst wird. Registrierungsnummer der Review bei PROSPERO: CRD42020202558. KW - Metaanalyse KW - Gesichtsschmerz KW - Lasertherapie KW - Akupunktur KW - systematic review KW - TMD KW - chronic pain KW - extraoral intervention Y1 - 2024 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-347990 N1 - Appendix VII bis X fehlen in der gedr. Ausgabe ER - TY - THES A1 - Richard, Annika T1 - Systematic Review of Measles, Mumps and Rubella Vaccination Programs in Selected European Countries and the Influence of Migration Movements T1 - Systematischer Review der Impfstrategien für Masern, Mumps und Röteln in ausgewählten europäischen Ländern und die Auswirkungen von Migrationsbewegungen N2 - Masern, Mumps und Röteln sind virale Infektionskrankheiten, die schwere und verheerenden Komplikationen bei den erkrankten Personen verursachen können. Die weltweite Krankheitslast dieser Infektionskrankheiten ist hoch und könnte durch erfolgreiche Impfstrategien merkenswert reduziert werden. Die WHO hat daher das Ziel der globalen Eliminierung von Masern und Röteln sowie der Kontrolle der oft simultan geimpften Mumps Erkrankung gesetzt. Im Jahr 2010 einigten sich die WHO-Mitgliedstaaten der europäischen Region, gezielte Strategien zu verfolgen, um Masern und Röteln bis Ende des Jahres 2015 in Europa zu eliminieren. Analysen bezüglich des aktuellen Fortschrittes werden daher zunehmend relevanter. Als Teil dieser systematischen Literaturrecherche wurden die Immunisierungsstrategien, Impfraten und Krankheitsinzidenzen von elf europäischen Ländern untersucht und ihre Fortschritte im Hinblick auf die Krankheitseliminierung bewertet. Eine erfolgreiche Prävention der endemischen Übertragung von Masern, Mumps oder Röteln Viren konnte in mehreren Ländern erreicht werden, darunter Schweden, Kroatien, Griechenland und Spanien. Den Ländern Österreich, Frankreich, Deutschland, Italien, Polen, Türkei und dem Vereinigten Königreich von Großbritannien und Nordirland ist es trotz verbesserter Immunisierungsraten bisher nicht gelungen, die Eliminierungsziele zu erreichen. In der Türkei, Italien und Polen, kam es in den letzten Jahren zu starken Anstiegen der Fallzahlen, welche die Masern, Mumps und Röteln Kontrolle in Europa deutlich erschweren und das zeitnahe Erreichen der Eliminationsziele gefährden. Unzureichend immunisierte Bevölkerungsgruppen, die zu einer Aufrechterhaltung der Infektionserkrankungen im europäischen Raum beitragen können, wurden identifiziert. Dazu zählen Säuglinge und Kleinkinder, Jugendliche und junge Erwachsene, Männer, kürzlich eingewanderte Personen und Flüchtlinge, sowie reisende ethnischer Minderheiten. Die Gründe für das erhöhte Risiko einer Masern, Mumps oder Röteln Infektion unter diesen Personengruppen sind vielfältig und ein Ergebnis von verschiedenen historischen und aktuellen Impfstrategien, kulturellen, politischen und religiösen Unterschieden, sowie persönlichem Glauben und Ansichten. Das Reisen und die Migration von infizierten Personen nach und zwischen den verschiedenen europäischen Ländern spielt auch eine wesentliche Rolle bei der kontinuierlichen Übertragung der Erkrankungen in Europa. Nur durch eine ausreichend hohe Immunität der Bevölkerung kann das Auftreten von größeren Ausbrüchen trotz der Einfuhr viraler Erreger verhindert werden. Bestrebungen sollte daher die Immunisierung aller impffähigen Personen umfassen, sowie die Erweiterung spezifischer Impfstrategien für unzureichend immunisierte Bevölkerungsgruppen, die nur schwer durch Routineimpfungen zu erreichen sind. Europäische Länder, in denen die WHO Eliminierungsziele bisher nicht erreicht wurden, könnten möglicherweise von alternativen Impfstrategien profitieren. Ein einheitlicher, europaweiter MMR-Impfplan basierend auf den erfolgreichen Immunisierungsverfahren der Länder, die Masern, Mumps und Röteln erfolgreich bekämpft haben, stellt ein wirksames Instrument zur Verbesserung der allgemeinen Bevölkerungsimmunität und Kontrolle der drei Infektionskrankheiten dar. Ein Entwurf solch eines Impfplanes wurde im Rahmen dieser Dissertation erstellt und enthält Strategien für das Erreichen ungeschützter Bevölkerungsgruppen, unabhängig von Alter, Geschlecht oder Migrationshintergrund. Die Umsetzung einheitlicher Impfempfehlungen bringt mehrere Herausforderungen mit sich. Die vielen Vorteile im Hinblick auf die verbesserte Immunisierung, Überwachung und Bekämpfung der Erkrankungen lassen die Aufwände jedoch als berechtigt erscheinen. Die endemische Eliminierung von Masern, Mumps und Röteln Viren innerhalb der europäischen Region ist durchaus erzielbar. Die aktuelle epidemiologische Situation deutet jedoch darauf hin, dass das Ziel nicht bis zum Ende des Jahres 2015 erreicht wird, sondern weitere Bestrebungen auf internationaler Ebene notwendig sind, um eine wirksame Krankheitsbekämpfung in der näheren Zukunft zu erreichen. Durch nationale und internationale Verbesserungen der Immunisierungsstrategien und gezielten Impfkampagnen sowie Erkrankungs-Meldesystemen und laborchemischen Erregerbestätigungen kann eine weitgefächerte Bevölkerungsimmunität erzielt und Krankheitseliminierung unter adäquatem Monitoring des Fortschritts im gesamten europäischen Raum erreicht werden. N2 - Measles, mumps and rubella are viral infectious diseases that may cause severe and devastating complications among affected individuals. The disease burden of all three diseases is high, but could be reduced entirely through successful vaccination strategies. As such, the WHO has established the goal of globally eliminating measles and rubella and concomitantly controlling the frequently co-vaccinated mumps. In 2010, the WHO European Region member states agreed to strengthen efforts to eliminate measles and rubella from Europe by the end of 2015. As this date draws closer, progress analyses become increasingly relevant. In this systematic literature review, the immunization strategies, vaccination coverages and disease incidences of eleven European nations were assessed and their progress towards disease elimination evaluated. Successful prevention of the endemic transmission of measles, mumps, or rubella could be achieved in several nations, including Sweden, Croatia, Greece and Spain. Austria, France, Germany, Italy, Poland, Turkey and the United Kingdom of Great Britain and Northern Ireland, though having improved their overall immunization rates, have not yet been able to reach the elimination goals. In Turkey, Italy and Poland, sharp increases in case numbers during recent years are potentially threatening the successful measles, mumps and rubella control in Europe. Pockets of susceptible population groups that may contribute to the perpetuation of the diseases have been identified. They include infants and young children, adolescents and young adults, adolescent and adult males, recent immigrants and refugees,and traveling ethnic minority groups. Reasons for the increased risk of infection among these groups are manifold and a result of various historic and current vaccination practices, cultural, political and religious differences, as well as individual believes and concerns. Travel and migration of infected individuals to and between the various European nations also play an essential role in the continual transmission of measles, mumps and rubella in Europe. Only an adequate population-wide immunity can prevent the occurrence of major outbreaks due to viral importation. Efforts should therefore be made to immunize all population members able to receive vaccinations and to offer additional immunization opportunities to those susceptible population subgroups that are difficult to reach through routine vaccination programs. In countries struggling to meet the WHO elimination goals, alternative immunization practices may be necessary. A uniform, European-wide MMR vaccination schedule based on the successful immunization methods of countries that have eliminated measles, mumps and rubella may be an effective tool for improving the overall population-wide immunity and controlling the three diseases. A model for such a schedule was created and includes strategies for reaching population members regardless of age, gender or migratory background. The implementation of uniform immunization recommendations is challenging, but the advantages in terms of improved vaccination, surveillance and disease control methods may be worth at least considering such a strategy in Europe. Measles, mumps and rubella elimination may be attainable in the WHO European Region. The current epidemiological situation suggests that the goal is unlikely to be reached by the end of 2015, but through continued international efforts and collaboration, effective disease control could be achieved in the near future. In the meantime, improvements in immunization strategies, vaccination coverages, supplementary campaigns as well as disease notification systems and confirmations should be made on a national and international level, so that an adequate population-wide immunity can be established and the disease elimination progresses effectively monitored within the entire European region. KW - Masern KW - Mumps KW - Röteln KW - Impfung KW - systematic review KW - migration KW - Impfplan KW - vaccination program Y1 - 2015 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-138033 ER - TY - JOUR A1 - Fricke, Julia A1 - Ávila, Gabriela A1 - Keller, Theresa A1 - Weller, Karsten A1 - Lau, Susanne A1 - Maurer, Marcus A1 - Zuberbier, Torsten A1 - Keil, Thomas T1 - Prevalence of chronic urticaria in children and adults across the globe: Systematic review with meta‐analysis JF - Allergy N2 - Background and objectives: Urticaria is a frequent skin condition, but reliable prevalence estimates from population studies particularly of the chronic form are scarce. The objective of this study was to systematically evaluate and summarize the prevalence of chronic urticaria by evaluating population‐based studies worldwide. Methods: We performed a systematic search in PUBMED and EMBASE for population‐based studies of cross‐sectional or cohort design and studies based on health insurance/system databases. Risk of bias was assessed using a specific tool for prevalence studies. For meta‐analysis, we used a random effects model. Results: Eighteen studies were included in the systematic evaluation and 11 in the meta‐analysis including data from over 86 000 000 participants. Risk of bias was mainly moderate, whereas the statistical heterogeneity (I\(^{2}\)) between the studies was high. Asian studies combined showed a higher point prevalence of chronic urticaria (1.4%, 95%‐CI 0.5‐2.9) than those from Europe (0.5%, 0.2‐1.0) and Northern American (0.1%, 0.1‐0.1). Women were slightly more affected than men, whereas in children < 15 years we did not find a sex‐specific difference in the prevalence. The four studies that examined time trends indicated an increasing prevalence of chronic urticaria over time. Conclusions: On a global level, the prevalence of chronic urticaria showed considerable regional differences. There is a need to obtain more sex‐specific population‐based and standardized international data particularly for children and adolescents, different chronic urticaria subtypes and potential risk and protective factors. KW - chronic urticaria KW - meta‐analysis KW - prevalence KW - sex differences KW - systematic review Y1 - 2020 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-213700 VL - 75 IS - 2 SP - 423 EP - 432 ER - TY - JOUR A1 - Petzke, Frank A1 - Klose, Petra A1 - Welsch, Patrick A1 - Sommer, Claudia A1 - Häuser, Winfried T1 - Opioids for chronic low back pain: An updated systematic review and meta‐analysis of efficacy, tolerability and safety in randomized placebo‐controlled studies of at least 4 weeks of double‐blind duration JF - European Journal of Pain N2 - Background and Objective This updated systematic review evaluated the efficacy, tolerability and safety of opioids compared to placebo in non‐malignant chronic low back pain. Databases and Data Treatment Clinicaltrials.gov, CENTRAL, MEDLINE and PsycINFO were searched from October 2013 to May 2019. Randomized controlled trials comparing opioids with placebo and at least 4 weeks of double‐blinded duration were analysed. Primary outcomes were pain relief of 50% or greater, disability, tolerability and safety. Effects were summarized by a random effects model using risk differences or standardized mean differences. We added nine new studies with 2,980 participants for a total of 21 studies with 7,650 participants. Study duration ranged between 4 and 15 weeks. Studies with a parallel and cross‐over design: Based on very low to low‐quality evidence, opioids provided no clinically relevant pain relief of 50% or greater, but a clinically relevant reduction of disability compared to placebo. Enriched enrolment randomized withdrawal (EERW) design: Based on very low to low‐quality evidence, opioids provided a clinically relevant pain relief of 50% or greater, but not a clinically relevant reduction of disability compared to placebo. There was no clinically relevant harm with regard to serious adverse events by opioids compared to placebo in studies with parallel/cross‐over and EERW design. There was a relevant harm with regard to drop out rates due to adverse events in studies with parallel/cross‐over, but not in studies with EERW design. Conclusions Opioids may provide a safe and clinically relevant pain relief for 4–15 weeks in highly selected patients. Significance Within the context of randomized controlled trials of 4–15 weeks, opioids provided a clinically relevant pain relief of 30% or greater and a clinically relevant reduction of disability compared to placebo in non‐malignant chronic low back pain. Number needed to treat for an additional drop out due to side effects was 11 (95% confidence interval: 6–33). Assessment of abuse and addiction was incomplete. The frequency of serious adverse events including deaths did not differ from placebo. KW - opioids KW - back pain KW - systematic review Y1 - 2020 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-218498 VL - 24 IS - 3 SP - 497 EP - 517 ER - TY - JOUR A1 - Willeke, Kristina A1 - Janson, Patrick A1 - Zink, Katharina A1 - Stupp, Carolin A1 - Kittel-Schneider, Sarah A1 - Berghöfer, Anne A1 - Ewert, Thomas A1 - King, Ryan A1 - Heuschmann, Peter U. A1 - Zapf, Andreas A1 - Wildner, Manfred A1 - Keil, Thomas T1 - Occurrence of mental illness and mental health risks among the self-employed: a systematic review JF - International Journal of Environmental Research and Public Health N2 - We aimed to systematically identify and evaluate all studies of good quality that compared the occurrence of mental disorders in the self-employed versus employees. Adhering to the Cochrane guidelines, we conducted a systematic review and searched three major medical databases (MEDLINE, Web of Science, Embase), complemented by hand search. We included 26 (three longitudinal and 23 cross-sectional) population-based studies of good quality (using a validated quality assessment tool), with data from 3,128,877 participants in total. The longest of these studies, a Swedish national register evaluation with 25 years follow-up, showed a higher incidence of mental illness among the self-employed compared to white-collar workers, but a lower incidence compared to blue-collar workers. In the second longitudinal study from Sweden the self-employed had a lower incidence of mental illness compared to both blue- and white-collar workers over 15 years, whereas the third longitudinal study (South Korea) did not find a difference regarding the incidence of depressive symptoms over 6 years. Results from the cross-sectional studies showed associations between self-employment and poor general mental health and stress, but were inconsistent regarding other mental outcomes. Most studies from South Korea found a higher prevalence of mental disorders among the self-employed compared to employees, whereas the results of cross-sectional studies from outside Asia were less consistent. In conclusion, we found evidence from population-based studies for a link between self-employment and increased risk of mental illness. Further longitudinal studies are needed examining the potential risk for the development of mental disorders in specific subtypes of the self-employed. KW - incidence KW - mental disorders KW - mental health KW - mental illness KW - prevalence KW - self-employed KW - small business KW - systematic review Y1 - 2021 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-245085 SN - 1660-4601 VL - 18 IS - 16 ER - TY - JOUR A1 - Janson, Patrick A1 - Willeke, Kristina A1 - Zaibert, Lisa A1 - Budnick, Andrea A1 - Berghöfer, Anne A1 - Kittel-Schneider, Sarah A1 - Heuschmann, Peter U. A1 - Zapf, Andreas A1 - Wildner, Manfred A1 - Stupp, Carolin A1 - Keil, Thomas T1 - Mortality, morbidity and health-related outcomes in informal caregivers compared to non-caregivers: a systematic review JF - International Journal of Environmental Research and Public Health N2 - A systematic overview of mental and physical disorders of informal caregivers based on population-based studies with good methodological quality is lacking. Therefore, our aim was to systematically summarize mortality, incidence, and prevalence estimates of chronic diseases in informal caregivers compared to non-caregivers. Following PRISMA recommendations, we searched major healthcare databases (CINAHL, MEDLINE and Web of Science) systematically for relevant studies published in the last 10 years (without language restrictions) (PROSPERO registration number: CRD42020200314). We included only observational cross-sectional and cohort studies with low risk of bias (risk scores 0–2 out of max 8) that reported the prevalence, incidence, odds ratio (OR), hazard ratio (HR), mean- or sum-scores for health-related outcomes in informal caregivers and non-caregivers. For a thorough methodological quality assessment, we used a validated checklist. The synthesis of the results was conducted by grouping outcomes. We included 22 studies, which came predominately from the USA and Europe. Informal caregivers had a significantly lower mortality than non-caregivers. Regarding chronic morbidity outcomes, the results from a large longitudinal German health-insurance evaluation showed increased and statistically significant incidences of severe stress, adjustment disorders, depression, diseases of the spine and pain conditions among informal caregivers compared to non-caregivers. In cross-sectional evaluations, informal caregiving seemed to be associated with a higher occurrence of depression and of anxiety (ranging from 4 to 51% and 2 to 38%, respectively), pain, hypertension, diabetes and reduced quality of life. Results from our systematic review suggest that informal caregiving may be associated with several mental and physical disorders. However, these results need to be interpreted with caution, as the cross-sectional studies cannot determine temporal relationships. The lower mortality rates compared to non-caregivers may be due to a healthy-carer bias in longitudinal observational studies; however, these and other potential benefits of informal caregiving deserve further attention by researchers. KW - cohort studies KW - longitudinal studies KW - cross-sectional studies KW - family caregivers KW - informal caregiving KW - mental health KW - physical health KW - population-based studies KW - systematic review Y1 - 2022 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-275219 SN - 1660-4601 VL - 19 IS - 10 ER - TY - JOUR A1 - Weibel, Stephanie A1 - Popp, Maria A1 - Reis, Stefanie A1 - Skoetz, Nicole A1 - Garner, Paul A1 - Sydenham, Emma T1 - Identifying and managing problematic trials: A research integrity assessment tool for randomized controlled trials in evidence synthesis JF - Research Synthesis Methods N2 - Evidence synthesis findings depend on the assumption that the included studies follow good clinical practice and results are not fabricated or false. Studies which are problematic due to scientific misconduct, poor research practice, or honest error may distort evidence synthesis findings. Authors of evidence synthesis need transparent mechanisms to identify and manage problematic studies to avoid misleading findings. As evidence synthesis authors of the Cochrane COVID-19 review on ivermectin, we identified many problematic studies in terms of research integrity and regulatory compliance. Through iterative discussion, we developed a research integrity assessment (RIA) tool for randomized controlled trials for the update of this Cochrane review. In this paper, we explain the rationale and application of the RIA tool in this case study. RIA assesses six study criteria: study retraction, prospective trial registration, adequate ethics approval, author group, plausibility of methods (e.g., randomization), and plausibility of study results. RIA was used in the Cochrane review as part of the eligibility check during screening of potentially eligible studies. Problematic studies were excluded and studies with open questions were held in awaiting classification until clarified. RIA decisions were made independently by two authors and reported transparently. Using the RIA tool resulted in the exclusion of >40% of studies in the first update of the review. RIA is a complementary tool prior to assessing “Risk of Bias” aiming to establish the integrity and authenticity of studies. RIA provides a platform for urgent development of a standard approach to identifying and managing problematic studies. KW - COVID-19 pandemic KW - systematic review KW - research integrity KW - randomized controlled trial KW - good clinical practice KW - evidence synthesis Y1 - 2023 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-318236 VL - 14 IS - 3 SP - 357 EP - 369 ER - TY - THES A1 - Dangl [geb. Stimmer], Magdalena T1 - Die Wirksamkeit von Schienentherapie und okklusalen Einschleifmaßnahmen unter Berücksichtigung des Chronifizierungsgrades Craniomandibulärer Dysfunktionen: Eine Systematische Übersichtsarbeit mit Metaanalyse T1 - The effectiveness of occlusal splints and adjustments with regard to the chronification process of temporomandibular disorders in adults: A systematic review and metaanalysis N2 - Hintergrund: Die fehlende Diagnostik des patientInnenindividuellen CMD-Schmerzchronifizierungsgrades könnte Grund für die Heterogenität der Studienergebnisse zur Effektivität von Schienentherapie und okklusalen Einschleifmaßnahmen sein. Ziele: Dieser Systematische Review mit Metaanalyse hat als Ziel, die Effektivität von Schienentherapie und okklusalen Einschleifmaßnahmen bei der Behandlung von CMD unter besonderer Berücksichtigung des Grades der Schmerzchronifizierung zu untersuchen. Literaturquellen: Die Datenbanken Pubmed/MEDLINE, EMBASE, Cochrane Library, Livivo, OpenGrey, drks.de, Clinicaltrials.gov., sowie zusätzliche nicht gelistete Literatur wurden hierzu durchsucht. Auswahlkriterien: Analysiert wurden randomisierte klinische Studien, welche erwachsene PatientInnen mit einer schmerzhaften CMD untersuchten, die mit einer Okklusionsschiene oder okklusalen Einschleifmaßnahmen in jeglicher Kombination behandelt wurden. Die Studien wurden nach Hinweisen untersucht, die vermuten ließen, dass die ProbandInnen unter einer chronifizierten dysfunktionalen CMD Schmerzen litten. Anschließend wurde die Effektivität der Interventionen im Hinblick auf den erfassten bzw. vermuteten Chronifizierungsgrad differenziert betrachtet. Die Effektivität wurde bzgl. der folgenden Messparameter untersucht: aktuelle Schmerzintensität in Ruhe, maximal aktive Kieferöffnungskapazität, Kiefergelenkgeräusche, Palpationsschmerzen aus der Kaumuskulatur, Depressivität und somatoforme Beschwerden. Studienbewertung: Nachdem die eingeschlossenen Studien ausgewertet, in ihrer Qualität bewertet (Risk of Bias-Tool des Cochrane-Instituts) und die Daten extrahiert worden waren, wurde eine Metaanalyse mithilfe des Review Managers (RevMan 5.3) des Cochrane Instituts durchgeführt. Ergebnisse: ProbandInnen mit funktionalen Schmerzen nach den hier definierten Kriterien erfuhren bis zu 6 Monate nach Behandlungsbeginn eine statistisch signifikant stärkere Schmerzreduktion (p<0,00001) sowie niedrigere Werte der somatoformen Beschwerden (p=0,01) und Depression-Scores (p=0,002) als Probanden mit dysfunktionalen Schmerzen. Dagegen verbesserte sich die Kieferöffnungskapazität in dieser Subgruppe nicht statistisch signifikant mehr (p=0,40). Im kurzfristigen Zeitraum von bis zu 6 Monaten konnte die Okklusionsschiene verglichen mit einer Placebo-Schiene stärker CMD-Schmerzen senken (p=0,0002), wohingegen der Effektivitätsunterschied der Messparameter Kieferöffnungskapazität und Kiefergelenkgeräusche nicht statistisch signifikant war. Im Vergleich zu keiner Behandlung war die Okklusionsschiene im Zeitraum bis zu 6 Monaten statistisch signifikant effektiver in der Schmerzreduktion (p<0,00001); 6 bis 12 Monate nach Behandlungsbeginn war keine signifikant bessere Effektivität in der Schmerzreduktion zu verzeichnen (p=0,07). Die maximale Kieferöffnungskapazität zeigte in diesem Vergleich kein statistisch signifikantes Ergebnis im kurzfristigen Zeitraum. Die Schmerzreduktion im kurzfristigen Zeitraum ähnelte derer anderer aktiver Interventionen. Als Kointervention bringt die Schienentherapie in keinem der untersuchten Endpunkte und Zeiträume einen statistisch signifikanten Mehrwert mit sich. Eine erhöhte Vertikaldimension könnte die Effektivität der Okklusionsschiene verbessern. Ansonsten ist die Effektivität unterschiedlicher Okklusionsschienen vergleichbar, unter Berücksichtigung folgender Beobachtungen: eine ARS senkt die Schmerzen einer arthrogenen CMD (p=0,001) und eine Stabilisierungsschiene die Schmerzen einer myogenen oder gemischten CMD (p<0,00001) effektiver als keine Behandlung. Intraorale Adjustierungen eine Verbesserung der Schmerzsymptomatik erzielen (p=0,01). Die langfristige Effektivität der Interventionen konnte aufgrund der geringen Datenlage nicht ausreichend untersucht werden. Registrierungsnummer der Review bei PROSPERO: CRD42019123169. N2 - Background: The lack of diagnosis of patient specific pain chronicity in TMDs could be the reason for the heterogeneity of the study results on the effectiveness of occlusal splint therapy and occlusal adjustment measures. Objectives: This systematic review with meta-analysis was done to investigate the effectiveness of occlusal splint therapy and occlusal adjustment in the treatment of TMDs with respect to the degree of pain chronicity. Literature sources: The following databases were searched: Pubmed/MEDLINE, EMBASE, Cochrane Library, Livivo, OpenGrey, drks.de, Clinicaltrials.gov. as well as additional hand search in relevant literature. Criteria for the selection of suitable studies: All randomized clinical trials with adult participants with painful TMD, treated with an occlusal splint or occlusal adjustment in any combination were considered. The studies were then examined for factors presumably associated with chronic TMD in the sense of pain dysfunction. Subsequently, the effectiveness of the interventions was examined in a differentiated manner with regard to the assigned degree of pain chronicity. The effectiveness was examined in terms of the following outcomes: current pain intensity, maximum jaw opening capacity, temporomandibular joint (TMJ) sounds, pain on palpation from the masticatory muscles and the TMJs, depression and somatoform complaints. Study assessment: All included studies were evaluated regarding their quality (with the Risk of Bias tool of the Cochrane Collaboration). We extracted the data for the systematic review, and conducted a meta-analysis using the Review Manager (RevMan 5.3) of the Cochrane Collaboration. Results: Patients with functional orofacial pain according to the criteria defined here experienced a statistically significant higher pain reduction (p<0.00001) and lower values of somatoform pain (p=0.01) and depression (p=0.002) in the short-term period of up to 6 months after treatment than subjects with dysfunctional orofacial pain. In contrast, mouth opening restrictions in this subgroup did not improve significantly more (p=0.40). Over the short term, the occlusal splint was significantly more effective in reducing TMD pain than a placebo splint (p=0.0002), whereas the difference in effect between the endpoints maximum mouth opening capacity and TMJ sounds was not statistically significant. Compared to no treatment, the occlusal splint was significantly more effective in reducing pain in the short term (p<0.00001), while the effect was no longer statistically significant in the medium term (6 to 12 months after treatment). Based on mostly patients with functional pain, the maximum mouth opening capacity showed no statistically significant difference in this comparison in terms of the short-term period (p=0.28). Pain reduction in the short-term period was similarly effective compared to other active interventions (p=0.22). As a co-intervention, splint therapy did not show a statistically significant benefit in any of the endpoints and time periods investigated. An increased vertical dimension might improve the effectiveness of the occlusal splint. Otherwise the effectiveness of different occlusal splints is roughly comparable, as long as it is considered that an ARS treats arthrogenic TMD pain (p=0.001) and a stabilizing splint treats the pain of a CMD of myogenic or mixed origin (p<0.00001) more efficiently compared to no treatment. Contrary to current belief, occlusal adjustment could result in a more effective pain reduction compared to different control groups (p=0.01). The long-term effectiveness of the interventions could not be sufficiently investigated due to the limited data available. Registration number of the review at PROSPERO: CRD42019123169. KW - Gesichtsschmerz KW - Aufbissschiene KW - Metaanalyse KW - Chronischer Schmerz KW - Systematische Übersichtsarbeit KW - Craniomandibuläre Dysfunktion KW - Okklusale Adjustierung KW - Okklusionsschiene KW - Schmerzchronifizierung KW - systematic review KW - meta-analysis KW - temporomandibular disorders KW - occlusal splint KW - occlusal adjustment Y1 - 2022 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-256755 ER - TY - JOUR A1 - Müller, Sophie A1 - Köhler, Franziska A1 - Hendricks, Anne A1 - Kastner, Carolin A1 - Börner, Kevin A1 - Diers, Johannes A1 - Lock, Johan F. A1 - Petritsch, Bernhard A1 - Germer, Christoph-Thomas A1 - Wiegering, Armin T1 - Brain metastases from colorectal cancer: a systematic review of the literature and meta-analysis to establish a guideline for daily treatment JF - Cancers N2 - Colorectal cancer (CRC) is the third most common malignancy worldwide. Most patients with metastatic CRC develop liver or lung metastases, while a minority suffer from brain metastases. There is little information available regarding the presentation, treatment, and overall survival of brain metastases (BM) from CRC. This systematic review and meta-analysis includes data collected from three major databases (PubMed, Cochrane, and Embase) based on the key words “brain”, “metastas*”, “tumor”, “colorectal”, “cancer”, and “malignancy”. In total, 1318 articles were identified in the search and 86 studies matched the inclusion criteria. The incidence of BM varied between 0.1% and 11.5%. Most patients developed metastases at other sites prior to developing BM. Lung metastases and KRAS mutations were described as risk factors for additional BM. Patients with BM suffered from various symptoms, but up to 96.8% of BM patients were asymptomatic at the time of BM diagnosis. Median survival time ranged from 2 to 9.6 months, and overall survival (OS) increased up to 41.1 months in patients on a multimodal therapy regimen. Several factors including age, blood levels of carcinoembryonic antigen (CEA), multiple metastases sites, number of brain lesions, and presence of the KRAS mutation were predictors of OS. For BM diagnosis, MRI was considered to be state of the art. Treatment consisted of a combination of surgery, radiation, or systemic treatment. KW - brain metastases KW - cerebral metastases KW - BM KW - colorectal cancer KW - CRC KW - systematic review KW - meta-analysis Y1 - 2021 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-228883 SN - 2072-6694 VL - 13 IS - 4 ER -