Pub Date : 2022-06-14eCollection Date: 2022-01-01DOI: 10.3205/000310
Simone Miller, Katharina Peters, Martin Ptok
Background: Neuromuscular electrical stimulation (NMES) has been used as a treatment option in the therapy of dysphagia for several years. In a previous review of the literature, it was concluded that NMES might be a valuable adjunct in patients with dysphagia and in patients with vocal fold paresis. However, due to different stimulation protocols, electrode positioning and various underlying pathological conditions, it was difficult to compare the studies which were identified and it was concluded that more empirical data is needed to fully understand the benefits provided by NMES. The purpose of this systematic review is, therefore, to evaluate recent studies regarding a potential effectiveness of transcutaneous NMES applied to the anterior neck as a treatment for dysphagia considering these different aspects.
Method: For this systematic review, a selective literature research in PubMed has been carried out on 5th May 2021 using the terms electrical stimulation AND dysphagia and screened for inclusion criteria by two reviewers in Rayyan. The search resulted in 62 hits.
Results: Studies were excluded due to their publication language; because they did not meet inclusion criteria; because the topical focus was a different one; or because they did not qualify as level 2 studies. Eighteen studies were identified with varying patient groups, stimulation protocols, electrode placement and therapy settings. However, 16 studies have reported of beneficial outcomes in relation with NMES.
Discussion: The purpose of this systematic review was to evaluate the most recent studies regarding a potential effectiveness of NMES as a treatment for oropharyngeal dysphagia considering different aspects. It could generally be concluded that there is a considerable amount of level 2 studies which suggest that NMES is an effective treatment option, especially when combined with TDT for patients with dysphagia after stroke and patients with Parkinson's disease, or with different kinds of brain injuries. Further research is still necessary in order to clarify which stimulation protocols, parameters and therapy settings are most beneficial for certain patient groups and degrees of impairment.
{"title":"Review of the effectiveness of neuromuscular electrical stimulation in the treatment of dysphagia - an update.","authors":"Simone Miller, Katharina Peters, Martin Ptok","doi":"10.3205/000310","DOIUrl":"https://doi.org/10.3205/000310","url":null,"abstract":"<p><strong>Background: </strong>Neuromuscular electrical stimulation (NMES) has been used as a treatment option in the therapy of dysphagia for several years. In a previous review of the literature, it was concluded that NMES might be a valuable adjunct in patients with dysphagia and in patients with vocal fold paresis. However, due to different stimulation protocols, electrode positioning and various underlying pathological conditions, it was difficult to compare the studies which were identified and it was concluded that more empirical data is needed to fully understand the benefits provided by NMES. The purpose of this systematic review is, therefore, to evaluate recent studies regarding a potential effectiveness of transcutaneous NMES applied to the anterior neck as a treatment for dysphagia considering these different aspects.</p><p><strong>Method: </strong>For this systematic review, a selective literature research in PubMed has been carried out on 5<sup>th</sup> May 2021 using the terms <i>electrical stimulation AND dysphagia</i> and screened for inclusion criteria by two reviewers in Rayyan. The search resulted in 62 hits.</p><p><strong>Results: </strong>Studies were excluded due to their publication language; because they did not meet inclusion criteria; because the topical focus was a different one; or because they did not qualify as level 2 studies. Eighteen studies were identified with varying patient groups, stimulation protocols, electrode placement and therapy settings. However, 16 studies have reported of beneficial outcomes in relation with NMES.</p><p><strong>Discussion: </strong>The purpose of this systematic review was to evaluate the most recent studies regarding a potential effectiveness of NMES as a treatment for oropharyngeal dysphagia considering different aspects. It could generally be concluded that there is a considerable amount of level 2 studies which suggest that NMES is an effective treatment option, especially when combined with TDT for patients with dysphagia after stroke and patients with Parkinson's disease, or with different kinds of brain injuries. Further research is still necessary in order to clarify which stimulation protocols, parameters and therapy settings are most beneficial for certain patient groups and degrees of impairment.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":" ","pages":"Doc08"},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9284430/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40645807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-06-14eCollection Date: 2022-01-01DOI: 10.3205/000311
Maria Ntioudi, Katerina Vasiliadou, Parthena Charalampidou-Keremidou
Background: Pyometra is a rare gynecological condition and is characterized by pus accumulation in the uterine cavity. It occurs more frequently in postmenopausal women than tubo-ovarian abscesses, which constitute a more common gynecological complication among premenopausal women.
Objective: A 72-year-old woman was admitted to our emergency department with lower abdominal pain, diarrhea and fever for the last three days. The laboratory results were indicative to sepsis. The clinical examination revealed sensitivity by palpation of the lower abdomen without any signs of acute abdomen. The gynecological assessment showed pus outflow through the cervix and a pus culture was done. The ultrasound examination found an enlarged uterus, full of hypoechoic fluid, unclear borders between endometrium-myometrium, a mixed echogenicity adnexal mass and no free fluid in the pouch of Douglas. A computed tomography (CT) of the abdomen showed the presence of pyometra and a tubo-ovarian abscess of the right adnexa.
Method: The patient was treated with intravenous antibiotic therapy. When the patient was hemodynamically stable and afebrile, she underwent ultrasound-guided dilatation and curettage of the cervical canal and the endometrium in order to exclude an underlying malignancy, under general anesthesia.
Results: The patient responded promptly to the intravenous antibiotic therapy which was adapted to the pus culture result. The laboratory results withdrew to normal values and the patient was discharged after fifteen days of hospitalization in an afebrile and hemodynamically stable condition.
Conclusion: Pyometra and tubo-ovarian abscess in postmenopausal women could be a lethal complication of pelvic inflammatory disease. The key in treatment is the dilatation of the cervix and drainage of the pyometra. The administration of intravenous antibiotics and drainage through the cervix could be a suitable method of treatment for pyometra in older patients or those with poor performance status if only the histological examination is negative for malignancy.
{"title":"Idiopathic pyometra and tubo-ovarian abscess in a postmenopausal patient treated conservatively.","authors":"Maria Ntioudi, Katerina Vasiliadou, Parthena Charalampidou-Keremidou","doi":"10.3205/000311","DOIUrl":"https://doi.org/10.3205/000311","url":null,"abstract":"<p><strong>Background: </strong>Pyometra is a rare gynecological condition and is characterized by pus accumulation in the uterine cavity. It occurs more frequently in postmenopausal women than tubo-ovarian abscesses, which constitute a more common gynecological complication among premenopausal women.</p><p><strong>Objective: </strong>A 72-year-old woman was admitted to our emergency department with lower abdominal pain, diarrhea and fever for the last three days. The laboratory results were indicative to sepsis. The clinical examination revealed sensitivity by palpation of the lower abdomen without any signs of acute abdomen. The gynecological assessment showed pus outflow through the cervix and a pus culture was done. The ultrasound examination found an enlarged uterus, full of hypoechoic fluid, unclear borders between endometrium-myometrium, a mixed echogenicity adnexal mass and no free fluid in the pouch of Douglas. A computed tomography (CT) of the abdomen showed the presence of pyometra and a tubo-ovarian abscess of the right adnexa.</p><p><strong>Method: </strong>The patient was treated with intravenous antibiotic therapy. When the patient was hemodynamically stable and afebrile, she underwent ultrasound-guided dilatation and curettage of the cervical canal and the endometrium in order to exclude an underlying malignancy, under general anesthesia.</p><p><strong>Results: </strong>The patient responded promptly to the intravenous antibiotic therapy which was adapted to the pus culture result. The laboratory results withdrew to normal values and the patient was discharged after fifteen days of hospitalization in an afebrile and hemodynamically stable condition.</p><p><strong>Conclusion: </strong>Pyometra and tubo-ovarian abscess in postmenopausal women could be a lethal complication of pelvic inflammatory disease. The key in treatment is the dilatation of the cervix and drainage of the pyometra. The administration of intravenous antibiotics and drainage through the cervix could be a suitable method of treatment for pyometra in older patients or those with poor performance status if only the histological examination is negative for malignancy.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":" ","pages":"Doc09"},"PeriodicalIF":0.0,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9284429/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40645808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Since the era when macular hole was considered untreatable, macular hole surgery has come a long way to being one of the most successful surgeries. Internal limiting membrane (ILM) peeling has been an essential step of macular hole surgery since the establishment of the role of ILM in the aetiopathogenesis and progression of macular hole. However, the novel technique was not all virtuous. It had some vices which were not evident immediately. With the advent of spectral domain optical coherence tomography, short- and long-term effects of ILM peeling on macular structures were known; and with microperimetry, its effect on the function of macula could be evaluated. The technique has evolved with time from total peeling to inverted flap to just temporal peeling and temporal flap in an attempt to mitigate its adverse effects and to improve its surgical outcome. ILM abrasion technique and Ocriplasmin may eliminate the need of ILM peeling in selected cases, but they have their own limitations. We here discuss the role of ILM in the pathogenesis of macular hole, the benefits and adverse effects of ILM peeling, and the various modifications of the procedure, to then explore the alternatives.
{"title":"Internal limiting membrane peeling in macular hole surgery.","authors":"Deepti Pradhan, Lalit Agarwal, Ichhya Joshi, Anamika Kushwaha, Kshitij Aditya, Archana Kumari","doi":"10.3205/000309","DOIUrl":"https://doi.org/10.3205/000309","url":null,"abstract":"<p><p>Since the era when macular hole was considered untreatable, macular hole surgery has come a long way to being one of the most successful surgeries. Internal limiting membrane (ILM) peeling has been an essential step of macular hole surgery since the establishment of the role of ILM in the aetiopathogenesis and progression of macular hole. However, the novel technique was not all virtuous. It had some vices which were not evident immediately. With the advent of spectral domain optical coherence tomography, short- and long-term effects of ILM peeling on macular structures were known; and with microperimetry, its effect on the function of macula could be evaluated. The technique has evolved with time from total peeling to inverted flap to just temporal peeling and temporal flap in an attempt to mitigate its adverse effects and to improve its surgical outcome. ILM abrasion technique and Ocriplasmin may eliminate the need of ILM peeling in selected cases, but they have their own limitations. We here discuss the role of ILM in the pathogenesis of macular hole, the benefits and adverse effects of ILM peeling, and the various modifications of the procedure, to then explore the alternatives.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":" ","pages":"Doc07"},"PeriodicalIF":0.0,"publicationDate":"2022-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9204259/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40581234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
C. Biehl, S. Stötzel, Lydia Schock, G. Szalay, C. Heiss
Objectives: 10% of all fractures occur in the fingers and metacarpal region. Early mobilization with preservation of grip function is the goal of any therapy for these injuries. Osteosyntheses with plates are used in complex fractures that do not allow any other treatment. The aim of this retrospective study was to evaluate the performance and safety of the Stryker Hand System. Patients and methods: Between 2010 and 2019, 190 patients underwent surgical treatment with plates for fractures of the fingers and metacarpal region. Of these, 140 operations could be analyzed according to the inclusion criteria based on clinical and radiological parameters. Results: Three-quarters of the patients were male. The mean age at the time of surgery was 39.3±16 years. Falling was the leading cause for hand fractures, and the most common were fractures of the shaft (>52%). More than 15% were complex hand injuries with more than one fractured finger. The majority of patients were healthy non-smokers without systemic diseases and relevant medical history. Conclusion: The Stryker Finger Plates are safe implants with good results that are consistent with those reported in the literature. The trend is also toward stable-angle implants for fracture treatment of the finger, in order to enable the earliest possible functional, safe mobilization. Level of Evidence: Level: IV; outcome-study, retrospective
{"title":"Treatment of hand and finger fractures with the Stryker Hand Plating System","authors":"C. Biehl, S. Stötzel, Lydia Schock, G. Szalay, C. Heiss","doi":"10.3205/000305","DOIUrl":"https://doi.org/10.3205/000305","url":null,"abstract":"Objectives: 10% of all fractures occur in the fingers and metacarpal region. Early mobilization with preservation of grip function is the goal of any therapy for these injuries. Osteosyntheses with plates are used in complex fractures that do not allow any other treatment. The aim of this retrospective study was to evaluate the performance and safety of the Stryker Hand System. Patients and methods: Between 2010 and 2019, 190 patients underwent surgical treatment with plates for fractures of the fingers and metacarpal region. Of these, 140 operations could be analyzed according to the inclusion criteria based on clinical and radiological parameters. Results: Three-quarters of the patients were male. The mean age at the time of surgery was 39.3±16 years. Falling was the leading cause for hand fractures, and the most common were fractures of the shaft (>52%). More than 15% were complex hand injuries with more than one fractured finger. The majority of patients were healthy non-smokers without systemic diseases and relevant medical history. Conclusion: The Stryker Finger Plates are safe implants with good results that are consistent with those reported in the literature. The trend is also toward stable-angle implants for fracture treatment of the finger, in order to enable the earliest possible functional, safe mobilization. Level of Evidence: Level: IV; outcome-study, retrospective","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43236109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Lack of proper oral care among elderly people in nursing homes is associated with increased morbidity and hospitalisation. The ability of the individual to maintain sufficient oral self-care is difficult for caregivers to assess, and thus, caregivers often risk providing suboptimal oral care. Sensor-based tools exist that can support the caregiving staff in achieving a better understanding of who among the elderly are able to perform proper self-care, and who cannot and thus need additional assistance from caregivers. How such systems should be designed and deployed in nursing homes, and how they will be perceived by caregivers has not been investigated sufficiently yet. Objectives: The aim of this study was to gain a better understanding of how caregiving staff perceives the introduction of sensor-based systems that allow the caregivers to automatically discover who among the elderly residents are able to adhere to the given recommendation on daily oral self-care, and who among them are in need of further assistance, as well as whether there is potential for saving costs. Methods: In a mixed methods qualitative study, we visited three nursing homes where we had recently deployed, or were about to deploy, electrical toothbrushes and a basic oral-care adherence aid system. Nursing home staff was interviewed during the field studies about their initial reactions to introducing such a system as part of their daily workflow. The field study was supported by a literature review. Results: Caregiving staff welcomed the introduction of a sensor-based oral-care adherence aid system, which would identify any elderly who could no longer achieve a sufficient level of oral self-care. Improving oral care for the elderly may not only prevent serious consequential diseases, but also generate considerable savings with a return on investment of at least 1:2.5. Conclusion: Sensor-based oral-care adherence aid systems that monitor oral-care adherence, meaning the ability of the individual elderly to properly perform teeth and/or denture brushing as part of normal self-care efforts, appear useful and relevant to introduce. More work is needed to provide a better understanding of the long-term user experience of both caregiving staff and elderly. There is also a need for more high-quality long-term clinical studies of further preventive effects of oral hygiene measures and their economic benefit.
{"title":"Oral-care adherence. Service design for nursing homes – initial caregiver reactions and socio-economic analysis","authors":"Stefan Wagner, I. Rosian-Schikuta, Jorge Cabral","doi":"10.3205/000306","DOIUrl":"https://doi.org/10.3205/000306","url":null,"abstract":"Background: Lack of proper oral care among elderly people in nursing homes is associated with increased morbidity and hospitalisation. The ability of the individual to maintain sufficient oral self-care is difficult for caregivers to assess, and thus, caregivers often risk providing suboptimal oral care. Sensor-based tools exist that can support the caregiving staff in achieving a better understanding of who among the elderly are able to perform proper self-care, and who cannot and thus need additional assistance from caregivers. How such systems should be designed and deployed in nursing homes, and how they will be perceived by caregivers has not been investigated sufficiently yet. Objectives: The aim of this study was to gain a better understanding of how caregiving staff perceives the introduction of sensor-based systems that allow the caregivers to automatically discover who among the elderly residents are able to adhere to the given recommendation on daily oral self-care, and who among them are in need of further assistance, as well as whether there is potential for saving costs. Methods: In a mixed methods qualitative study, we visited three nursing homes where we had recently deployed, or were about to deploy, electrical toothbrushes and a basic oral-care adherence aid system. Nursing home staff was interviewed during the field studies about their initial reactions to introducing such a system as part of their daily workflow. The field study was supported by a literature review. Results: Caregiving staff welcomed the introduction of a sensor-based oral-care adherence aid system, which would identify any elderly who could no longer achieve a sufficient level of oral self-care. Improving oral care for the elderly may not only prevent serious consequential diseases, but also generate considerable savings with a return on investment of at least 1:2.5. Conclusion: Sensor-based oral-care adherence aid systems that monitor oral-care adherence, meaning the ability of the individual elderly to properly perform teeth and/or denture brushing as part of normal self-care efforts, appear useful and relevant to introduce. More work is needed to provide a better understanding of the long-term user experience of both caregiving staff and elderly. There is also a need for more high-quality long-term clinical studies of further preventive effects of oral hygiene measures and their economic benefit.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48314511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Horizon scanning aims to systematically identify upcoming health technologies and thus allows policy-makers to be better prepared for the entry of new medicines with possibly high price tags into the national health system. The aim of this study is to survey the existence of national and cross-national horizon scanning systems for medicines in European countries. Methods: Experts working in public authorities (members of the Pharmaceutical Pricing and Reimbursement Information/PPRI network) in the WHO European region participated in surveys in 2014 and 2019 and informed about the status of horizon scanning in their country (response rate: 14 and 44 countries, respectively). Identified advanced horizon scanning systems as of 2019 were further investigated based on a literature review. Results: In 2019, six countries (Iceland, Italy, the Netherlands, Norway, Sweden, United Kingdom) reported systematic use of horizon scanning for some new medicines, and four countries (Austria, Denmark, France, Ireland) had some horizon scanning activities ongoing. No systematic use of horizon scanning was reported from the remaining 34 countries. The findings of the survey undertaken five years earlier were similar, with even fewer systems in place. A recent development is the establishment of cross-country initiatives of governments that aim, among others, to jointly perform horizon scanning; the International Horizon Scanning Initiative (IHSI) initiated by the Beneluxa collaboration is the most advanced undertaking in this respect. Countries with systematic use tend to have horizon scanning fully integrated in a system for the management of new medicines, and they use horizon scanning outcomes to inform decisions as to whether or not a Health Technology Assessment will be conducted and price negotiations be started. Differences between existing horizon scanning systems mainly concern the timings of scanning and reporting, the sources for the inputs and the accessibility of the findings. Conclusion: There appears to be a discrepancy between the perceived importance of horizon scanning based on some eye-opening examples in the past and its actual implementation in European health systems. The latter is likely attributable to horizon scanning being resource-intensive. The establishment of new national and international horizon scanning systems offers the opportunity to investigate their impact on sustainable access to affordable medicines from the start.
{"title":"“Ready for the future?” – Status of national and cross-country horizon scanning systems for medicines in European countries","authors":"S. Vogler","doi":"10.3205/000307","DOIUrl":"https://doi.org/10.3205/000307","url":null,"abstract":"Background: Horizon scanning aims to systematically identify upcoming health technologies and thus allows policy-makers to be better prepared for the entry of new medicines with possibly high price tags into the national health system. The aim of this study is to survey the existence of national and cross-national horizon scanning systems for medicines in European countries. Methods: Experts working in public authorities (members of the Pharmaceutical Pricing and Reimbursement Information/PPRI network) in the WHO European region participated in surveys in 2014 and 2019 and informed about the status of horizon scanning in their country (response rate: 14 and 44 countries, respectively). Identified advanced horizon scanning systems as of 2019 were further investigated based on a literature review. Results: In 2019, six countries (Iceland, Italy, the Netherlands, Norway, Sweden, United Kingdom) reported systematic use of horizon scanning for some new medicines, and four countries (Austria, Denmark, France, Ireland) had some horizon scanning activities ongoing. No systematic use of horizon scanning was reported from the remaining 34 countries. The findings of the survey undertaken five years earlier were similar, with even fewer systems in place. A recent development is the establishment of cross-country initiatives of governments that aim, among others, to jointly perform horizon scanning; the International Horizon Scanning Initiative (IHSI) initiated by the Beneluxa collaboration is the most advanced undertaking in this respect. Countries with systematic use tend to have horizon scanning fully integrated in a system for the management of new medicines, and they use horizon scanning outcomes to inform decisions as to whether or not a Health Technology Assessment will be conducted and price negotiations be started. Differences between existing horizon scanning systems mainly concern the timings of scanning and reporting, the sources for the inputs and the accessibility of the findings. Conclusion: There appears to be a discrepancy between the perceived importance of horizon scanning based on some eye-opening examples in the past and its actual implementation in European health systems. The latter is likely attributable to horizon scanning being resource-intensive. The establishment of new national and international horizon scanning systems offers the opportunity to investigate their impact on sustainable access to affordable medicines from the start.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42648115","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
B. Buchberger, Katharina Scholl, Laura Krabbe, L. Spiller, Beate Lux
Background: Radioactive material and ionising radiation play a central role in medical diagnostics and therapy. The benefit of ionising radiation is opposed by the risk of irreparable damage of the human organism. This risk, especially for developing malign neoplasms, has particularly been investigated in the population surviving the atomic bombing of Hiroshima and Nagasaki, but also increasingly in persons with occupational or medical exposure to ionising radiation. Methods: We conducted a systematic search for publications in English and German in relevant databases in March 2016. Retrievals were screened by two independent reviewers. We included examinations using imaging procedures with ionising radiation. The assessment of methodological quality was done concerning representativeness, risk of bias, and further limitations, and reporting quality was assessed using the RECORD checklist. Results: The systematic searches identified seven cross-sectional, one register, and four cohort studies. An increase in collective effective doses analogue to the increase of computed tomography (CT) examinations could be observed. An increased risk of brain tumours in children after exposition to head CT and by an increase of the number of examinations was shown. For children with predisposing factors, an increased risk of tumours of the central nerve system, leukemia, and lymphoma was found. Furthermore, a general risk for malign neoplasms or haemoblastoma, and a specific risk for lymphoma after CT examinations of different parts of the body could be observed. Discussion: Taking into consideration a mostly unclear representativeness of studies and an unclear or high risk of bias as well as lack of comparability due to different research questions, the validity of results is limited. Conclusion: The risk of bias due to a large number of reference sources must be reduced in studies leading to realistic estimates of collective radiation doses. The risk of CT-induced radiation exposure for children should be investigated by further studies with a follow-up of at least ten years.
{"title":"Radiation exposure by medical X-ray applications","authors":"B. Buchberger, Katharina Scholl, Laura Krabbe, L. Spiller, Beate Lux","doi":"10.3205/000308","DOIUrl":"https://doi.org/10.3205/000308","url":null,"abstract":"Background: Radioactive material and ionising radiation play a central role in medical diagnostics and therapy. The benefit of ionising radiation is opposed by the risk of irreparable damage of the human organism. This risk, especially for developing malign neoplasms, has particularly been investigated in the population surviving the atomic bombing of Hiroshima and Nagasaki, but also increasingly in persons with occupational or medical exposure to ionising radiation. Methods: We conducted a systematic search for publications in English and German in relevant databases in March 2016. Retrievals were screened by two independent reviewers. We included examinations using imaging procedures with ionising radiation. The assessment of methodological quality was done concerning representativeness, risk of bias, and further limitations, and reporting quality was assessed using the RECORD checklist. Results: The systematic searches identified seven cross-sectional, one register, and four cohort studies. An increase in collective effective doses analogue to the increase of computed tomography (CT) examinations could be observed. An increased risk of brain tumours in children after exposition to head CT and by an increase of the number of examinations was shown. For children with predisposing factors, an increased risk of tumours of the central nerve system, leukemia, and lymphoma was found. Furthermore, a general risk for malign neoplasms or haemoblastoma, and a specific risk for lymphoma after CT examinations of different parts of the body could be observed. Discussion: Taking into consideration a mostly unclear representativeness of studies and an unclear or high risk of bias as well as lack of comparability due to different research questions, the validity of results is limited. Conclusion: The risk of bias due to a large number of reference sources must be reduced in studies leading to realistic estimates of collective radiation doses. The risk of CT-induced radiation exposure for children should be investigated by further studies with a follow-up of at least ten years.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45711991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Moritz Hadwiger, N. Dagres, G. Hindricks, H. L’Hoest, U. Marschall, A. Katalinic, Fabian-Simon Frielitz
Introduction: This study investigates the runtime and costs of biventricular defibrillators (CRT-D) and biventricular pacemakers (CRT-P). Accurate estimates of cardiac resynchronization therapy (CRT) device runtime across all manufactures are rare, especially for CRT-P. Methods: Health claims data of a large nationwide German health insurance was used to analyze CRT device runtime. We defined device runtime as the time between the date of implantation and the date of generator change or removal. The median costs for implantation, change, and removal of a CRT device were calculated accordingly. Results: In total, the data set comprises 17,826 patients. A total of 4,296 complete runtimes for CRT-D devices and 429 complete runtimes for CRT-P devices were observed. Median device runtime was 6.04 years for CRT-D devices and 8.16 years for CRT-P devices (log-rank test p<0.0001). The median cost of implantation for a CRT-D device was 14,270 EUR, and for a CRT-P device 9,349 EUR. Conclusions: Compared to CRT-P devices, CRT-D devices had a significantly shorter device runtime of about two years. Moreover, CRT-D devices were associated with higher cost. The study provides important findings that can be utilized by cost-effectiveness analyses.
{"title":"Device runtime and costs of cardiac resynchronization therapy pacemakers – a health claims data analysis","authors":"Moritz Hadwiger, N. Dagres, G. Hindricks, H. L’Hoest, U. Marschall, A. Katalinic, Fabian-Simon Frielitz","doi":"10.3205/000304","DOIUrl":"https://doi.org/10.3205/000304","url":null,"abstract":"Introduction: This study investigates the runtime and costs of biventricular defibrillators (CRT-D) and biventricular pacemakers (CRT-P). Accurate estimates of cardiac resynchronization therapy (CRT) device runtime across all manufactures are rare, especially for CRT-P. Methods: Health claims data of a large nationwide German health insurance was used to analyze CRT device runtime. We defined device runtime as the time between the date of implantation and the date of generator change or removal. The median costs for implantation, change, and removal of a CRT device were calculated accordingly. Results: In total, the data set comprises 17,826 patients. A total of 4,296 complete runtimes for CRT-D devices and 429 complete runtimes for CRT-P devices were observed. Median device runtime was 6.04 years for CRT-D devices and 8.16 years for CRT-P devices (log-rank test p<0.0001). The median cost of implantation for a CRT-D device was 14,270 EUR, and for a CRT-P device 9,349 EUR. Conclusions: Compared to CRT-P devices, CRT-D devices had a significantly shorter device runtime of about two years. Moreover, CRT-D devices were associated with higher cost. The study provides important findings that can be utilized by cost-effectiveness analyses.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45511401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Preventive and health-promoting policies can guide (place- and space-specific) factors influencing human health, such as the physical and social environment. Required is data that can lead to a more nuanced decision-making process and identify both existing and future challenges. Along with the rise of new technologies, and thus the multiple opportunities to use and process data, new options have emerged to measure and monitor factors that affect health. Thus, in recent years, several gateways for open data (including governmental and geospatial data) have become available. At present, an increasing number of research institutions as well as (state and private) companies and citizens’ initiatives are providing data. However, there is a lack of overviews covering the range of such offerings regarding health. In particular, for geographically differentiated analyses, there are challenges related to data availability at different spatial levels and the growing number of data providers. Objectives: This paper aims to provide an overview of open data resources available in the context of space and health to date. It also describes the technical and legal conditions for using open data. Results: An up-to-date summary of results including information on relevant data access and terms of use is provided along with a web visualization. All data is available for further use under an open license.
{"title":"Availability of open data for spatial public health research","authors":"Manuela Peters, H. Zeeb","doi":"10.3205/000303","DOIUrl":"https://doi.org/10.3205/000303","url":null,"abstract":"Background: Preventive and health-promoting policies can guide (place- and space-specific) factors influencing human health, such as the physical and social environment. Required is data that can lead to a more nuanced decision-making process and identify both existing and future challenges. Along with the rise of new technologies, and thus the multiple opportunities to use and process data, new options have emerged to measure and monitor factors that affect health. Thus, in recent years, several gateways for open data (including governmental and geospatial data) have become available. At present, an increasing number of research institutions as well as (state and private) companies and citizens’ initiatives are providing data. However, there is a lack of overviews covering the range of such offerings regarding health. In particular, for geographically differentiated analyses, there are challenges related to data availability at different spatial levels and the growing number of data providers. Objectives: This paper aims to provide an overview of open data resources available in the context of space and health to date. It also describes the technical and legal conditions for using open data. Results: An up-to-date summary of results including information on relevant data access and terms of use is provided along with a web visualization. All data is available for further use under an open license.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44554631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
I. Bruns, C. Schade-Brittinger, Frank Wissing, T. Ruppert, Martin Trillsch
The objective of clinical trials is to transfer findings gained from basic research to patients and to result in innovative treatment approaches. Along with basic research, results from clinical trials thus represent a core area of medical advances. As a location for clinical trials, Germany is currently well-positioned and internationally competitive. This is evident in its position as No. 2 in Europe and No. 3 worldwide – behind the US and UK – in clinical trials of pharmaceuticals [1]. Maintaining and further improving this favorable positioning as a location for clinical trials is in the mutual interest of all parties involved in the field of clinical research, patients, trial sites and sponsors of clinical trials. For patients, clinical trials offer opportunities to gain early access to innovative therapy options. In addition to the scientific interest from medical faculties, clinical research is thereby an important aspect for university clinics in Germany as they fulfill their medical care mandate. Their involvement in clinical trials gives physicians the ability to gather experience with new treatment approaches at an early stage and to pass this know-how on to their patients. A location’s clinical research is thus an important competitive factor in terms of international comparison as well. Industry likewise benefits from the favorable research infrastructure in Germany, which provides rapid patient recruitment and outstanding quality of results obtained and can thus contribute to the early approval of new drugs. From the perspective of the authors, it is therefore essential that Germany continues to remain competitive as a location for conducting clinical trials, precisely because the number of clinical trials is decreasing overall. Companies themselves are in international competition internally and externally, which often creates a certain pressure on trial preparation and thus on the start of a clinical trial. To ensure that a clinical trial can begin early, it is essential that contracts related to the trial are concluded quickly and simply, including remuneration for participants and full, transparent and comprehensible coverage of content for the business relationship. The swift agreement of key contractual and budgetary aspects is therefore in the interest of everyone involved. Against this backdrop, the German Association of Medical Faculties (MFT), the German Association of Academic Medical Centers (VUD), the Coordination Center for Clinical Studies (KKS-Netzwerk) and the German Association of Research-Based Pharmaceutical Companies (vfa) have held joint discussions regarding an important aspect of the contract negotiations – the cost consideration of clinical trials. As a result of these talks, these organizations have developed and published joint “Recommendations for the preparation of a total services calculation for remuneration related to the conduct of a clinical trial in a trial center” [2], [3]. The parties concerned s
{"title":"Joint recommendations for a total services account as a factor in simplifying contracts","authors":"I. Bruns, C. Schade-Brittinger, Frank Wissing, T. Ruppert, Martin Trillsch","doi":"10.3205/000276","DOIUrl":"https://doi.org/10.3205/000276","url":null,"abstract":"The objective of clinical trials is to transfer findings gained from basic research to patients and to result in innovative treatment approaches. Along with basic research, results from clinical trials thus represent a core area of medical advances. As a location for clinical trials, Germany is currently well-positioned and internationally competitive. This is evident in its position as No. 2 in Europe and No. 3 worldwide – behind the US and UK – in clinical trials of pharmaceuticals [1]. Maintaining and further improving this favorable positioning as a location for clinical trials is in the mutual interest of all parties involved in the field of clinical research, patients, trial sites and sponsors of clinical trials. For patients, clinical trials offer opportunities to gain early access to innovative therapy options. In addition to the scientific interest from medical faculties, clinical research is thereby an important aspect for university clinics in Germany as they fulfill their medical care mandate. Their involvement in clinical trials gives physicians the ability to gather experience with new treatment approaches at an early stage and to pass this know-how on to their patients. A location’s clinical research is thus an important competitive factor in terms of international comparison as well. Industry likewise benefits from the favorable research infrastructure in Germany, which provides rapid patient recruitment and outstanding quality of results obtained and can thus contribute to the early approval of new drugs. From the perspective of the authors, it is therefore essential that Germany continues to remain competitive as a location for conducting clinical trials, precisely because the number of clinical trials is decreasing overall. Companies themselves are in international competition internally and externally, which often creates a certain pressure on trial preparation and thus on the start of a clinical trial. To ensure that a clinical trial can begin early, it is essential that contracts related to the trial are concluded quickly and simply, including remuneration for participants and full, transparent and comprehensible coverage of content for the business relationship. The swift agreement of key contractual and budgetary aspects is therefore in the interest of everyone involved. Against this backdrop, the German Association of Medical Faculties (MFT), the German Association of Academic Medical Centers (VUD), the Coordination Center for Clinical Studies (KKS-Netzwerk) and the German Association of Research-Based Pharmaceutical Companies (vfa) have held joint discussions regarding an important aspect of the contract negotiations – the cost consideration of clinical trials. As a result of these talks, these organizations have developed and published joint “Recommendations for the preparation of a total services calculation for remuneration related to the conduct of a clinical trial in a trial center” [2], [3]. The parties concerned s","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43922998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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