Search

Purpose: Patients with abdominal rectus diastasis (ARD) may have muscular functional impairments, but clinics lack appropriate objective assessment tools. The aim was to establish the relative and absolute reliability, and convergent validity, of muscular activity using Surface Electromyography (SEMG) during isometric abdominal muscle strength testing in patients with ARD and controls without ARD. Methods: Twenty-six patients with ARD were matched for age, sex and BMI with controls without ARD. Participants were tested twice during isometric muscular contractions using SEMG located on six abdominal sites. Mean amplitude, fatigue, and recruitment order were analyzed. Relative reliability was evaluated with Intraclass Correlation Coefficients (ICC), while absolute reliability was estimated by calculating the Standard Error of Measurement and Minimal Detectable Change. Convergent validity was addressed in relation to participant characteristics, functional ability, and symptoms. Results: Mean SEMG amplitude for all abdominal wall muscle contractions showed moderate to excellent relative test–retest reliability, with ICC values ranging from 0.46 to 0.97. In contrast, fatigue and recruitment order displayed poor to moderate relative reliability in both groups. Absolute reliability measures were generally high. A moderate to high convergent validity (ARD: rho-value 0.41–0.70; Controls: rho-value 0.41–0.75) was observed for mean amplitude in relation to a functional sit-to-stand test, abdominal circumference, BMI, back pain, and quality-of-life. Conclusions: The results of applying SEMG during isometric abdominal muscle support practicing the method in clinics, although additional development is needed with further standardization and more functional testing. Furthermore, the method demonstrates construct validity in patients with ARD and in age- and sex-matched controls.

Purpose: Patients with abdominal rectus diastasis (ARD) may have muscular functional impairments, but clinics lack appropriate objective assessment tools. The aim was to establish the relative and absolute reliability, and convergent validity, of muscular activity using Surface Electromyography (SEMG) during isometric abdominal muscle strength testing in patients with ARD and controls without ARD. Methods: Twenty-six patients with ARD were matched for age, sex and BMI with controls without ARD. Participants were tested twice during isometric muscular contractions using SEMG located on six abdominal sites. Mean amplitude, fatigue, and recruitment order were analyzed. Relative reliability was evaluated with Intraclass Correlation Coefficients (ICC), while absolute reliability was estimated by calculating the Standard Error of Measurement and Minimal Detectable Change. Convergent validity was addressed in relation to participant characteristics, functional ability, and symptoms. Results: Mean SEMG amplitude for all abdominal wall muscle contractions showed moderate to excellent relative test–retest reliability, with ICC values ranging from 0.46 to 0.97. In contrast, fatigue and recruitment order displayed poor to moderate relative reliability in both groups. Absolute reliability measures were generally high. A moderate to high convergent validity (ARD: rho-value 0.41–0.70; Controls: rho-value 0.41–0.75) was observed for mean amplitude in relation to a functional sit-to-stand test, abdominal circumference, BMI, back pain, and quality-of-life. Conclusions: The results of applying SEMG during isometric abdominal muscle support practicing the method in clinics, although additional development is needed with further standardization and more functional testing. Furthermore, the method demonstrates construct validity in patients with ARD and in age- and sex-matched controls.

Purpose: Patients with abdominal rectus diastasis (ARD) may have muscular functional impairments, but clinics lack appropriate objective assessment tools. The aim was to establish the relative and absolute reliability, and convergent validity, of muscular activity using Surface Electromyography (SEMG) during isometric abdominal muscle strength testing in patients with ARD and controls without ARD. Methods: Twenty-six patients with ARD were matched for age, sex and BMI with controls without ARD. Participants were tested twice during isometric muscular contractions using SEMG located on six abdominal sites. Mean amplitude, fatigue, and recruitment order were analyzed. Relative reliability was evaluated with Intraclass Correlation Coefficients (ICC), while absolute reliability was estimated by calculating the Standard Error of Measurement and Minimal Detectable Change. Convergent validity was addressed in relation to participant characteristics, functional ability, and symptoms. Results: Mean SEMG amplitude for all abdominal wall muscle contractions showed moderate to excellent relative test–retest reliability, with ICC values ranging from 0.46 to 0.97. In contrast, fatigue and recruitment order displayed poor to moderate relative reliability in both groups. Absolute reliability measures were generally high. A moderate to high convergent validity (ARD: rho-value 0.41–0.70; Controls: rho-value 0.41–0.75) was observed for mean amplitude in relation to a functional sit-to-stand test, abdominal circumference, BMI, back pain, and quality-of-life. Conclusions: The results of applying SEMG during isometric abdominal muscle support practicing the method in clinics, although additional development is needed with further standardization and more functional testing. Furthermore, the method demonstrates construct validity in patients with ARD and in age- and sex-matched controls.

Purpose: Patients with abdominal rectus diastasis (ARD) may have muscular functional impairments, but clinics lack appropriate objective assessment tools. The aim was to establish the relative and absolute reliability, and convergent validity, of muscular activity using Surface Electromyography (SEMG) during isometric abdominal muscle strength testing in patients with ARD and controls without ARD. Methods: Twenty-six patients with ARD were matched for age, sex and BMI with controls without ARD. Participants were tested twice during isometric muscular contractions using SEMG located on six abdominal sites. Mean amplitude, fatigue, and recruitment order were analyzed. Relative reliability was evaluated with Intraclass Correlation Coefficients (ICC), while absolute reliability was estimated by calculating the Standard Error of Measurement and Minimal Detectable Change. Convergent validity was addressed in relation to participant characteristics, functional ability, and symptoms. Results: Mean SEMG amplitude for all abdominal wall muscle contractions showed moderate to excellent relative test–retest reliability, with ICC values ranging from 0.46 to 0.97. In contrast, fatigue and recruitment order displayed poor to moderate relative reliability in both groups. Absolute reliability measures were generally high. A moderate to high convergent validity (ARD: rho-value 0.41–0.70; Controls: rho-value 0.41–0.75) was observed for mean amplitude in relation to a functional sit-to-stand test, abdominal circumference, BMI, back pain, and quality-of-life. Conclusions: The results of applying SEMG during isometric abdominal muscle support practicing the method in clinics, although additional development is needed with further standardization and more functional testing. Furthermore, the method demonstrates construct validity in patients with ARD and in age- and sex-matched controls.

The recent COVID-19 pandemic has hit humanity very hard in ways rarely observed before. In this digitally connected world, the health informatics and investigation domains (both public and private) lack a robust framework to enable rapid investigation and cures. Since the data in the healthcare domain are highly confidential, any framework in the healthcare domain must work on real data, be verifiable, and support reproducibility for evidence purposes. In this paper, we propose a health informatics framework that supports data acquisition from various sources in real-time, correlates these data from various sources among each other and to the domain-specific terminologies, and supports querying and analyses. Various sources include sensory data from wearable sensors, clinical investigation (for trials and devices) data from private/public agencies, personnel health records, academic publications in the healthcare domain, and semantic information such as clinical ontologies and the Medical Subject Heading ontology. The linking and correlation of various sources include mapping personnel wearable data to health records, clinical oncology terms to clinical trials, and so on. The framework is designed such that the data are Findable, Accessible, Interoperable, and Reusable with proper Identity and Access Mechanisms. This practically means to tracing and linking each step in the data management lifecycle through discovery, ease of access and exchange, and data reuse. We present a practical use case to correlate a variety of aspects of data relating to a certain medical subject heading from the Medical Subject Headings ontology and academic publications with clinical investigation data. The proposed architecture supports streaming data acquisition and servicing and processing changes throughout the lifecycle of the data management. This is necessary in certain events, such as when the status of a certain clinical or other health-related investigation needs to be updated., SCOPUS: ar.j, info:eu-repo/semantics/published

BACKGROUND: Efficient recovery of circulating tumor DNA (ctDNA) depends on the quantity and quality of circulating cell-free DNA (ccfDNA). Here, we evaluated whether various ccfDNA extraction methods routinely applied in Dutch laboratories affect ccfDNA yield, ccfDNA integrity, and mutant ctDNA detection, using identical lung cancer patient-derived plasma samples. METHODS: Aliquots of 4 high-volume diagnostic leukapheresis plasma samples and one artificial reference plasma sample with predetermined tumor-derived mutations were distributed among 14 Dutch laboratories. Extractions of ccfDNA were performed according to local routine standard operating procedures and were analyzed at a central reference laboratory for mutant detection and assessment of ccfDNA quantity and integrity. RESULTS: Mutant molecule levels in extracted ccfDNA samples varied considerably between laboratories, but there was no indication of consistent above or below average performance. Compared to silica membrane-based methods, samples extracted with magnetic beads-based kits revealed an overall lower total ccfDNA yield (-29%; P < 0.0001) and recovered fewer mutant molecules (-41%; P < 0.01). The variant allelic frequency and sample integrity were similar. In samples with a higher-than-average total ccfDNA yield, an augmented recovery of mutant molecules was observed. CONCLUSIONS: In the Netherlands, we encountered diversity in preanalytical workflows with potential consequences on mutant ctDNA detection in clinical practice. Silica membrane-based methodologies resulted in the highest total ccfDNA yield and are therefore preferred to detect low copy numbers of relevant mutations. Harmonization of the extraction workflow for accurate quantification and sensitive detection is required to prevent introduction of technical divergence in the preanalytical phase and reduce interlaboratory discrepancies.

© 2022 IEEE. Personal use of this material is permitted. Permission from IEEE must be obtained for all other uses, in any current or future media, including reprinting/republishing this material for advertising or promotional purposes, creating new collective works, for resale or redistribution to servers or lists, or reuse of any copyrighted component of this work in other works., Wearable bioimpedance is a technique proposed to estimate breathing parameters such as respiratory rate (RR). However, its potential application lies in clinical investigation of daily-life activities like walking. This study evaluated the effect of the walking interference on the estimation of breathing parameters. 50 chronic obstructive pulmonary disease patients performed static and active measurements during thoracic bioimpedance acquisition. The static measurements included respiratory airflow for reference. The active measurements were used to estimate the walking interference from bioimpedance, and the obtained signals were added to static measurements for comparison with the reference. Afterward, we applied four different preprocessing methods to remove this walking interference and the resulting signals were used to detect the respiratory cycles and estimate breathing parameters (inspiratory time, expiratory time, duty cycle, and RR). The methods performed differently in terms of accuracy and mean average percentage error (MAPE), showing the need for specific preprocessing for active measurements. Furthermore, the MAPE values in the RR estimation were close to 3 % indicating that breathing parameters can be accurately estimated during walking. Accordingly, the present study reinforces the applicability of wearable bioimpedance for respiratory monitoring. Clinical relevance- This study exhibits the suitability of wearable bioimpedance to estimate accurate breathing param-eters during walking activities., This work was supported in part by the Universities and Research Secretariat from the Generalitat de Catalunya under Grant GRC 2017 SGR 01770 and, GrantFI-DGR, in part by the Agencia Estatal de Investigación from the Spanish Ministry of Science, Innovation and Universities and the European Regional Development Fund, under the Grant RTI 2018 098472B-I00, and in part by the CERCA Programme/Generalitat de Catalunya., Peer Reviewed, Postprint (author's final draft)

BACKGROUND: Efficient recovery of circulating tumor DNA (ctDNA) depends on the quantity and quality of circulating cell-free DNA (ccfDNA). Here, we evaluated whether various ccfDNA extraction methods routinely applied in Dutch laboratories affect ccfDNA yield, ccfDNA integrity, and mutant ctDNA detection, using identical lung cancer patient-derived plasma samples. METHODS: Aliquots of 4 high-volume diagnostic leukapheresis plasma samples and one artificial reference plasma sample with predetermined tumor-derived mutations were distributed among 14 Dutch laboratories. Extractions of ccfDNA were performed according to local routine standard operating procedures and were analyzed at a central reference laboratory for mutant detection and assessment of ccfDNA quantity and integrity. RESULTS: Mutant molecule levels in extracted ccfDNA samples varied considerably between laboratories, but there was no indication of consistent above or below average performance. Compared to silica membrane-based methods, samples extracted with magnetic beads-based kits revealed an overall lower total ccfDNA yield (-29%; P < 0.0001) and recovered fewer mutant molecules (-41%; P < 0.01). The variant allelic frequency and sample integrity were similar. In samples with a higher-than-average total ccfDNA yield, an augmented recovery of mutant molecules was observed. CONCLUSIONS: In the Netherlands, we encountered diversity in preanalytical workflows with potential consequences on mutant ctDNA detection in clinical practice. Silica membrane-based methodologies resulted in the highest total ccfDNA yield and are therefore preferred to detect low copy numbers of relevant mutations. Harmonization of the extraction workflow for accurate quantification and sensitive detection is required to prevent introduction of technical divergence in the preanalytical phase and reduce interlaboratory discrepancies.

Received 29 May 2018, Revised 2 November 2018, Accepted 2 November 2018, Available online 14 November 2018., Medical devices are under strict regulatory oversight worldwide and such regulations prioritise patient safety and efficacy over anything else. Contact lenses fall under the medical device category - a result of direct contact with the eye. Equally regulated are the contact lens care product solutions, which include cleaning and maintenance solutions and lubricating and rewetting drops. In the USA, it is the FDA Centre for Devices and Radiological Health (CDRH) overseeing the regulations of medical devices, since 1976. In the European Union, it is the EU Commission responsible for regulating devices in Member States. The categorisation of contact lenses into medical devices is based on their inherent risk to the wearer. Contact lenses are subject to crucial regulatory oversight from concept to clinical evaluation, clinical investigations through to the finished lens product, and finally, strict conditions associated with their marketing approval including post-marketing surveillance. The physiochemical and manufacturing testing, such as biocompatibility testing alongside pre-clinical stability, sterility and microbiological testing are just some of the essential testing lenses must endure. Only through understanding the inherent risks and potential complications that can arise from contact lens wear, can one truly appreciate the need to adhere to strict regulations. The challenge however, lies in the need for more standardised regulations and flexible approaches, ensuring innovative device technologies reach patients in a timely manner without compromising public health and safety. This review highlights some key requirement, differences and similarities between the FDA and EU administrations in the approval of contact lenses., Unión Europea. H2020, Depto. de Optometría y Visión, Fac. de Óptica y Optometría, TRUE, pub

RIVM rapport:In order to show that medical devices are safe and functional, it is necessary to do research in humans (clinical trials). In order to ensure the safety of the trial subjects (healthy volunteers or patients) and the scientific quality of this type of research, before the trial starts a Medical Ethics Review Committee (MERC) evaluates it to make sure it has been designed properly. This committee also assesses the trial to see if it is acceptable from an ethical point of view. If a clinical trial is carried out on a medical device that does not carry the CE mark, the trial must also be submitted to the Dutch Health and Youth Care Inspectorate in formation (IGJ). This is known as the 'obligation to notify'. Research carried out by the National Institute for Public Health and the Environment (RIVM) has shown that clinical trials are not always submitted to the IGJ. This could be because applicants are not aware of their obligation to notify, or because the clinical trial is only submitted when the study is actually starting. From 2015-2017, the number of notifications of clinical studies increased when compared with 2011-2013. This may be because the obligation to notify is now better recognised. In recent years, the IGJ and the Central Committee on Research Involving Human Subjects (CCMO) have been working together to actively spread information about this legal obligation. Applicants to MERCs for clinical trials reported their sources of information about the obligation to notify as being the websites of the IGJ and the CCMO, part of standard procedures at their hospitals, and training courses for researchers.

RIVM rapport:In order to show that medical devices are safe and functional, it is necessary to do research in humans (clinical trials). In order to ensure the safety of the trial subjects (healthy volunteers or patients) and the scientific quality of this type of research, before the trial starts a Medical Ethics Review Committee (MERC) evaluates it to make sure it has been designed properly. This committee also assesses the trial to see if it is acceptable from an ethical point of view. If a clinical trial is carried out on a medical device that does not carry the CE mark, the trial must also be submitted to the Dutch Health and Youth Care Inspectorate in formation (IGJ). This is known as the 'obligation to notify'. Research carried out by the National Institute for Public Health and the Environment (RIVM) has shown that clinical trials are not always submitted to the IGJ. This could be because applicants are not aware of their obligation to notify, or because the clinical trial is only submitted when the study is actually starting. From 2015-2017, the number of notifications of clinical studies increased when compared with 2011-2013. This may be because the obligation to notify is now better recognised. In recent years, the IGJ and the Central Committee on Research Involving Human Subjects (CCMO) have been working together to actively spread information about this legal obligation. Applicants to MERCs for clinical trials reported their sources of information about the obligation to notify as being the websites of the IGJ and the CCMO, part of standard procedures at their hospitals, and training courses for researchers.

RIVM rapport:In order to show that medical devices are safe and functional, it is necessary to do research in humans (clinical trials). In order to ensure the safety of the trial subjects (healthy volunteers or patients) and the scientific quality of this type of research, before the trial starts a Medical Ethics Review Committee (MERC) evaluates it to make sure it has been designed properly. This committee also assesses the trial to see if it is acceptable from an ethical point of view. If a clinical trial is carried out on a medical device that does not carry the CE mark, the trial must also be submitted to the Dutch Health and Youth Care Inspectorate in formation (IGJ). This is known as the 'obligation to notify'. Research carried out by the National Institute for Public Health and the Environment (RIVM) has shown that clinical trials are not always submitted to the IGJ. This could be because applicants are not aware of their obligation to notify, or because the clinical trial is only submitted when the study is actually starting. From 2015-2017, the number of notifications of clinical studies increased when compared with 2011-2013. This may be because the obligation to notify is now better recognised. In recent years, the IGJ and the Central Committee on Research Involving Human Subjects (CCMO) have been working together to actively spread information about this legal obligation. Applicants to MERCs for clinical trials reported their sources of information about the obligation to notify as being the websites of the IGJ and the CCMO, part of standard procedures at their hospitals, and training courses for researchers.

Introduction The main purpose of our study was to evaluate the accuracy of clinical investigation for meniscal tears associated with ACL injuries. We hypothesized that combined ACL injury can decrease the accuracy of clinical examination in acute onset. Materials and methods One hundred and thirty-seven patients with a mean age of 28.5 years (from 12 to 55) were prospectively examined for acute combined ACL and meniscal injuries, between March and November 2012 at our department. For meniscal tears, clinical examination was performed using McMurray test, Apley test and medial and lateral joint line tenderness. The diagnoses of ACL tear were made using Lachman test, jerk test and pivot-shift test, anterior drawer test and KT-2000 side-to-side difference. Each patient was examined using X-ray and MRI. All the patients underwent arthroscopic surgery performed by the same surgeon within 6 weeks after the injury. Finally, using the arthroscopic findings as gold standard, the sensitivity, specificity, accuracy, positive predictive value and negative predictive value of clinical investigation and MRI were evaluated. Results The specificity of clinical investigation was 63.5 and 46.0 % and the sensitivity was 74.4 and 77.3 % for the medial meniscus and the lateral meniscus, respectively. Overall, the accuracy of the clinical investigation was 70.3 % for the MM and 65.5 % for the lateral meniscus. The accuracy of MRI investigation was 76.4 and 69.5 % for medial and lateral meniscus, respectively. Discussion In combined acute ACL injury and meniscal tears, we have found a decreased accuracy of the clinical investigation. The remnants of the torn ACL and the synovitis increased the rate of false positives, and it could simulate meniscal tears. However, clinical investigation can provide sufficient information for the treatment decision and MRI can be avoided as a routine diagnostic tool. Level of evidence Level II, prospective study.

Transfusion support of patients with hemorrhagic shock has changed over time with the development of storage and processing methods. Transfusion medicine developed during World War I with the use of whole blood, and now in the developed world, component therapy predominates. In contrast, there is still clinical use of fresh whole blood (FWB) in the developing world, in a minority of children s hospitals, and in combat settings. Although there is a rationale for the use of FWB in massively bleeding patients compared with the use of individual components, it has rarely been analyzed in prospective randomized clinical trials. Recent retrospective studies in adult trauma and mixed critically ill patients have revived this decades-old controversial question of the value of FWB for patients with severe shock and coagulopathy or those at risk. The risks of FWB use have also been highlighted recently, which has caused some to focus on reducing these risks with alternative processing and storage methods. It is important to recognize that current processing and storage methods for components have also not been adequately explored to determine whether they affect clinical outcomes. In this article, we review potential benefits and risks of FWB use for patients with hemorrhagic shock from any cause, and how current and future processing and storage methods may affect efficacy and safety of FWB in this population. We intend this review to stimulate hypothesis generation and clinical investigation in determining when FWB may be indicated and how to optimally process and store FWB to maximize its risk-benefit ratio., Published in Anesthesia & Analgesia, v115 n4 p751-758, October 2012.

ElectroSonics Medical has developed a small handheld system for detecting Pneumothoraces in soldiers in far forward battlefield conditions. Based on Micropower Impulse Radar technology, the system uses light weight, consumes lower power and is easy to use and interpret. The current design integrates with the MC70 hand held computer which is part of the MC4 computing platforms. It can run on any computing platform that complies with USB 2.0 and is running a Microsoft operating system of XP or later. The system has passed all IEC 60601 test requirements and is being CE Marked for initial use in European clinical trails. One study in Switzerland has been completed and a publication is pending demonstrating the performance of the system in a trauma setting., The original document contains color images.

A substantial proportion of women with cervical cancer that have participated in cervical screening have a history of an abnormal cytology result. Our objective was to assess the impact of histological investigation and treatment of women with abnormal cytology on the subsequent risk of invasive cervical cancer. All invasive cervical cancer cases in Sweden 1999-2001 and five population-based control women per case were investigated. Clinical investigations and treatment were analysed in case women (N = 143) and control women (N = 176) below 67 with abnormal cytology results 0.5-6.5 years before the cases' diagnosis. Cervical cancer risk in relation to investigation [histology or not, punch biopsy, cervical curettage or cone/large loop excision of the transformation zone (LLETZ)], and treatment (treatment or not, excisional or ablative) was estimated as odds ratios (ORs) using logistic regression. Absence of histological assessment was associated with increased cancer risk, both after low-grade [OR 2.37; 95% confidence intervals (CI): 1.27-4.43] and high-grade squamous atypia (8.26; 2.37-28.8). Among women with histology, absence of treatment was associated with increased cancer risk (3.68; 1.53-8.84), also when biopsy showed low-grade atypia or normal findings (3.57; 1.18-10.8). Ablative therapy associated with increased risk compared with excisional (3.82; 1.01-14.4), and laser conisation associated with decreased risk compared with LLETZ (0.06; 0.01-0.36). In conclusion, low-grade as well as high-grade squamous atypical cytology results may warrant histological investigation, treatment reduced cancer risk even when histology was negative or showed low-grade atypia indicating a need for improvements in the diagnosis of high-grade lesions, and laser conisation was the most effective treatment.

A substantial proportion of women with cervical cancer that have participated in cervical screening have a history of an abnormal cytology result. Our objective was to assess the impact of histological investigation and treatment of women with abnormal cytology on the subsequent risk of invasive cervical cancer. All invasive cervical cancer cases in Sweden 1999-2001 and five population-based control women per case were investigated. Clinical investigations and treatment were analysed in case women (N = 143) and control women (N = 176) below 67 with abnormal cytology results 0.5-6.5 years before the cases' diagnosis. Cervical cancer risk in relation to investigation [histology or not, punch biopsy, cervical curettage or cone/large loop excision of the transformation zone (LLETZ)], and treatment (treatment or not, excisional or ablative) was estimated as odds ratios (ORs) using logistic regression. Absence of histological assessment was associated with increased cancer risk, both after low-grade [OR 2.37; 95% confidence intervals (CI): 1.27-4.43] and high-grade squamous atypia (8.26; 2.37-28.8). Among women with histology, absence of treatment was associated with increased cancer risk (3.68; 1.53-8.84), also when biopsy showed low-grade atypia or normal findings (3.57; 1.18-10.8). Ablative therapy associated with increased risk compared with excisional (3.82; 1.01-14.4), and laser conisation associated with decreased risk compared with LLETZ (0.06; 0.01-0.36). In conclusion, low-grade as well as high-grade squamous atypical cytology results may warrant histological investigation, treatment reduced cancer risk even when histology was negative or showed low-grade atypia indicating a need for improvements in the diagnosis of high-grade lesions, and laser conisation was the most effective treatment.

RIVM rapport:De technische documentatie van medische hulpmiddelen, die nog niet zijn toegelaten tot de markt en bedoeld zijn voor klinisch onderzoek, bevat ernstige tekortkomingen. Dit zou een verhoogd risico kunnen betekenen en de patientveiligheid kunnen beinvloeden. Het onderzoek richtte zich op de beschikbaarheid en kwaliteit van de technische documentatie zoals vereist in de Richtlijn medische hulpmiddelen 93/42/EEG (RMH), aangevuld met onderdelen die in direct verband staan met het gebruik en de veiligheid van een hulpmiddel maar in de vigerende RMH niet expliciet vereist zijn. Hoewel de respons van de geincludeerde fabrikanten (n=19) hoog was, zou de tijdige beschikbaarheid van dergelijke documentatie verbeterd kunnen worden. Gebleken is dat bij 95% van de fabrikanten de kwaliteit van een aanzienlijk deel van de expliciet vereiste technische documentatie ontoereikend was. Ernstige tekortkomingen werden gevonden in de onderdelen risicoanalyse, sterilisatie, etikettering, gebruiksaanwijzing en vigilantie. Deze onderdelen zijn essentieel voor de kwaliteit en veiligheid van medische hulpmiddelen. De kwaliteit van de aanvullende onderdelen betreffende eventuele geneesmiddelencomponenten en 'post market surveillance' was eveneens ontoereikend. Fabrikanten zouden voor het begin van een klinisch onderzoek nauwer kunnen gaan samenwerken met hun 'notified bodies' om de kwaliteit en veiligheid van medische hulpmiddelen beter te garanderen. Bovendien zouden Europese bevoegde autoriteiten en medisch ethische toetsingscommissies kunnen overwegen om het toezicht op klinisch onderzoek met medische hulpmiddelen te verhogen. Tijdens de lopende revisie van de RMH worden aan de onderdelen geneesmiddelencomponent en 'post market surveillance' al scherpere eisen gesteld., The technical documentation on non-market approved medical devices intended for clinical investigation contains major shortcomings. This could imply increased risks which could affect patient safety. The investigation described here focused on the availability and quality of the technical documentation which is required in the Medical Devices Directive 93/42/EEC (MDD), complemented by items directly related to the use and safety of a device but which are not explicitly required in the current MDD. Even though the response of included manufacturers (n=19) was high, the timely availability of such documentation could be improved. For 95% of the manufacturers, the quality of a substantial part of the required technical documentation was inadequate. Major shortcomings were found in items concerning risk analysis, sterilisation, labelling, instructions for use and vigilance, which are vital for the quality and safety of medical devices. Likewise the quality of complementary items concerning medicinal substance and post market surveillance was inadequate. In order to safeguard the quality and safety of medical devices more extensively manufacturers could liaise more with their notified bodies before the start of a clinical investigation. Furthermore, European competent authorities and ethics committees could consider an increased surveillance on clinical investigations with medical devices. Proposed amendments during the revision of the MDD are addressing some of its shortcomings, e.g. medicinal substances and post market surveillance.

RIVM rapport:De technische documentatie van medische hulpmiddelen, die nog niet zijn toegelaten tot de markt en bedoeld zijn voor klinisch onderzoek, bevat ernstige tekortkomingen. Dit zou een verhoogd risico kunnen betekenen en de patientveiligheid kunnen beinvloeden. Het onderzoek richtte zich op de beschikbaarheid en kwaliteit van de technische documentatie zoals vereist in de Richtlijn medische hulpmiddelen 93/42/EEG (RMH), aangevuld met onderdelen die in direct verband staan met het gebruik en de veiligheid van een hulpmiddel maar in de vigerende RMH niet expliciet vereist zijn. Hoewel de respons van de geincludeerde fabrikanten (n=19) hoog was, zou de tijdige beschikbaarheid van dergelijke documentatie verbeterd kunnen worden. Gebleken is dat bij 95% van de fabrikanten de kwaliteit van een aanzienlijk deel van de expliciet vereiste technische documentatie ontoereikend was. Ernstige tekortkomingen werden gevonden in de onderdelen risicoanalyse, sterilisatie, etikettering, gebruiksaanwijzing en vigilantie. Deze onderdelen zijn essentieel voor de kwaliteit en veiligheid van medische hulpmiddelen. De kwaliteit van de aanvullende onderdelen betreffende eventuele geneesmiddelencomponenten en 'post market surveillance' was eveneens ontoereikend. Fabrikanten zouden voor het begin van een klinisch onderzoek nauwer kunnen gaan samenwerken met hun 'notified bodies' om de kwaliteit en veiligheid van medische hulpmiddelen beter te garanderen. Bovendien zouden Europese bevoegde autoriteiten en medisch ethische toetsingscommissies kunnen overwegen om het toezicht op klinisch onderzoek met medische hulpmiddelen te verhogen. Tijdens de lopende revisie van de RMH worden aan de onderdelen geneesmiddelencomponent en 'post market surveillance' al scherpere eisen gesteld., The technical documentation on non-market approved medical devices intended for clinical investigation contains major shortcomings. This could imply increased risks which could affect patient safety. The investigation described here focused on the availability and quality of the technical documentation which is required in the Medical Devices Directive 93/42/EEC (MDD), complemented by items directly related to the use and safety of a device but which are not explicitly required in the current MDD. Even though the response of included manufacturers (n=19) was high, the timely availability of such documentation could be improved. For 95% of the manufacturers, the quality of a substantial part of the required technical documentation was inadequate. Major shortcomings were found in items concerning risk analysis, sterilisation, labelling, instructions for use and vigilance, which are vital for the quality and safety of medical devices. Likewise the quality of complementary items concerning medicinal substance and post market surveillance was inadequate. In order to safeguard the quality and safety of medical devices more extensively manufacturers could liaise more with their notified bodies before the start of a clinical investigation. Furthermore, European competent authorities and ethics committees could consider an increased surveillance on clinical investigations with medical devices. Proposed amendments during the revision of the MDD are addressing some of its shortcomings, e.g. medicinal substances and post market surveillance.

RIVM rapport:De technische documentatie van medische hulpmiddelen, die nog niet zijn toegelaten tot de markt en bedoeld zijn voor klinisch onderzoek, bevat ernstige tekortkomingen. Dit zou een verhoogd risico kunnen betekenen en de patientveiligheid kunnen beinvloeden. Het onderzoek richtte zich op de beschikbaarheid en kwaliteit van de technische documentatie zoals vereist in de Richtlijn medische hulpmiddelen 93/42/EEG (RMH), aangevuld met onderdelen die in direct verband staan met het gebruik en de veiligheid van een hulpmiddel maar in de vigerende RMH niet expliciet vereist zijn. Hoewel de respons van de geincludeerde fabrikanten (n=19) hoog was, zou de tijdige beschikbaarheid van dergelijke documentatie verbeterd kunnen worden. Gebleken is dat bij 95% van de fabrikanten de kwaliteit van een aanzienlijk deel van de expliciet vereiste technische documentatie ontoereikend was. Ernstige tekortkomingen werden gevonden in de onderdelen risicoanalyse, sterilisatie, etikettering, gebruiksaanwijzing en vigilantie. Deze onderdelen zijn essentieel voor de kwaliteit en veiligheid van medische hulpmiddelen. De kwaliteit van de aanvullende onderdelen betreffende eventuele geneesmiddelencomponenten en 'post market surveillance' was eveneens ontoereikend. Fabrikanten zouden voor het begin van een klinisch onderzoek nauwer kunnen gaan samenwerken met hun 'notified bodies' om de kwaliteit en veiligheid van medische hulpmiddelen beter te garanderen. Bovendien zouden Europese bevoegde autoriteiten en medisch ethische toetsingscommissies kunnen overwegen om het toezicht op klinisch onderzoek met medische hulpmiddelen te verhogen. Tijdens de lopende revisie van de RMH worden aan de onderdelen geneesmiddelencomponent en 'post market surveillance' al scherpere eisen gesteld., The technical documentation on non-market approved medical devices intended for clinical investigation contains major shortcomings. This could imply increased risks which could affect patient safety. The investigation described here focused on the availability and quality of the technical documentation which is required in the Medical Devices Directive 93/42/EEC (MDD), complemented by items directly related to the use and safety of a device but which are not explicitly required in the current MDD. Even though the response of included manufacturers (n=19) was high, the timely availability of such documentation could be improved. For 95% of the manufacturers, the quality of a substantial part of the required technical documentation was inadequate. Major shortcomings were found in items concerning risk analysis, sterilisation, labelling, instructions for use and vigilance, which are vital for the quality and safety of medical devices. Likewise the quality of complementary items concerning medicinal substance and post market surveillance was inadequate. In order to safeguard the quality and safety of medical devices more extensively manufacturers could liaise more with their notified bodies before the start of a clinical investigation. Furthermore, European competent authorities and ethics committees could consider an increased surveillance on clinical investigations with medical devices. Proposed amendments during the revision of the MDD are addressing some of its shortcomings, e.g. medicinal substances and post market surveillance.

Low participation among underserved populations in health research constrains progress in public health practices. From 2003 to 2005, Women’s Health Clinic patients at the VCU Health System were recruited to a trial investigating breast cancer risk communication. In secondary analyses, we examined dimensions of the recruitment of these diverse women. The sample characteristics (age, insurance, race and previous mammograms) were compared to the overall clinic. Of recruitment attempts for eligible women, 45% consented; of those who declined, the top cited reasons were lack of time (40%) and lack of interest (18%). Of 899 participants, 35% qualified for the indigent care program, compared to 31% of the overall clinic (P<0.001). Forty-five percent of participants were African American, compared to 54% of overall clinic patients (P<0.001). Participants were younger (50 vs. 53 years, P<0.001) than the overall clinic population. Nonrepresentative enrollment of patients in clinical trials is common and could lead to suboptimal applicability of findings. Although there were statistically significant race and age differences between the study sample and the overall population, we demonstrate that waiting room recruitment can engage diverse women in a clinical trial and cancer risk communication.

This course serves as a description and critical assessment of the major issues and stages of developing a pharmaceutical or biopharmaceutical. Topics covered include drug discovery, preclinical development, clinical investigation, manufacturing and regulatory issues considered for small and large molecules, and economic and financial considerations of the drug development process. A multidisciplinary perspective is provided by the faculty, who represent clinical, life, and management sciences. Various industry guests also participate.

This course serves as a description and critical assessment of the major issues and stages of developing a pharmaceutical or biopharmaceutical. Topics covered include drug discovery, preclinical development, clinical investigation, manufacturing and regulatory issues considered for small and large molecules, and economic and financial considerations of the drug development process. A multidisciplinary perspective is provided by the faculty, who represent clinical, life, and management sciences. Various industry guests also participate.

This course serves as a description and critical assessment of the major issues and stages of developing a pharmaceutical or biopharmaceutical. Topics covered include drug discovery, preclinical development, clinical investigation, manufacturing and regulatory issues considered for small and large molecules, and economic and financial considerations of the drug development process. A multidisciplinary perspective is provided by the faculty, who represent clinical, life, and management sciences. Various industry guests also participate.

This course serves as a description and critical assessment of the major issues and stages of developing a pharmaceutical or biopharmaceutical. Topics covered include drug discovery, preclinical development, clinical investigation, manufacturing and regulatory issues considered for small and large molecules, and economic and financial considerations of the drug development process. A multidisciplinary perspective is provided by the faculty, who represent clinical, life, and management sciences. Various industry guests also participate.

This report covers all research protocols that were administratively or technically supported by the Department of Clinical Investigation, Madigan Army Medical Center, during FY 2001. Included in the individual reports are title, investigators, funding, objective, technical approach, and progress for FY 2001. Also included in the report are personnel rosters for the Department, funding information, and presentations and publications emanating from Madigan Army Medical Center during FY 2001.

This study was designed to evaluate the relation between accommodative facility and accommodative and binocular dysfunctions. We determined whether failure to achieve 8 cycles per minute of binocular accommodative facility or 11 cycles per minute of monocular accommodative facility tends to be associated with these dysfunctions. Forty eight subjects, ages 10-30 years were examined and classified into four groups: 13 subjects with accommodative dysfunctions, 11 patients with binocular dysfunctions, 12 subjects with accommodative and binocular dysfunctions and 12 control subjects with refractive errors but no accommodative or binocular anomalies. Monocular and binocular accommodative facility was conducted using ±2.00 D flip lenses. In general, statistical analysis indicates that subjects with binocular and accommodative (ocular motor) anomalies performed significantly poorer than subjects of normal group on monocular and binocular facility tests. Monocular accommodative facility results showed more information about the dysfunction of the patient compared with the results of the binocular accommodative facility. In general data supported a relation between reduced accommodative facility and a general binocular dysfunction (accommodative or binocular) which demonstrates the importance of the accommodative facility test in diagnosing an accommodative or binocular anomaly.

This study was designed to evaluate the relation between accommodative facility and accommodative and binocular dysfunctions. We determined whether failure to achieve 8 cycles per minute of binocular accommodative facility or 11 cycles per minute of monocular accommodative facility tends to be associated with these dysfunctions. Forty eight subjects, ages 10-30 years were examined and classified into four groups: 13 subjects with accommodative dysfunctions, 11 patients with binocular dysfunctions, 12 subjects with accommodative and binocular dysfunctions and 12 control subjects with refractive errors but no accommodative or binocular anomalies. Monocular and binocular accommodative facility was conducted using ±2.00 D flip lenses. In general, statistical analysis indicates that subjects with binocular and accommodative (ocular motor) anomalies performed significantly poorer than subjects of normal group on monocular and binocular facility tests. Monocular accommodative facility results showed more information about the dysfunction of the patient compared with the results of the binocular accommodative facility. In general data supported a relation between reduced accommodative facility and a general binocular dysfunction (accommodative or binocular) which demonstrates the importance of the accommodative facility test in diagnosing an accommodative or binocular anomaly.

This report covers all research protocols that were administratively or technically supported by the Department of Clinical Investigation, Madigan Army Medical Center, during FY 1999. Included in the individual reports are title, investigators, funding, objective, technical approach, and progress for FY 1999. Also included in the report are personnel rosters for the Department, funding information, and presentations and publications emanating from Madigan Army Medical Center during FY 1999.

The Tuskegee Study, an observational study of over 400 sharecroppers with untreated syphilis, was conducted by the U.S. Public Health Service to document the course of the disease in blacks, and racial differences in the clinical manifestations of syphilis. The men were not told they had syphilis, not given counseling on avoiding spread of the disease, and not given treatment throughout the course of the study. The study became the longest (1932-1972) nontherapeutic experiment on humans in the history of medicine, and has come to represent not only the exploitation of blacks in medical history, but the potential for exploitation of any population that may be vulnerable because of race, ethnicity, gender, disability, age or social class. It is important for physicians who will be caring for an increasingly diverse nation to understand the lasting implications of this study for their patients, but the effects of the Tuskegee Syphilis Study are demonstrated most strikingly by unsuccessful attempts at improving representation of minority patients in clinical trials.

This report covers all research protocols that were administratively or technically supported by the Department of Clinical Investigation, Madigan Army Medical Center, during FY 1998. Included in the individual reports are title, investigators, funding, objective, technical approach, and progress for FY 1998. Also included in the report are personnel rosters for the Department, funding information, and presentations and publications emanating from Madigan Army Medical Center during FY 1998.

Subject report identifies the research activities conducted by Dwight David Eisenhower Army Medical Center investigators through protocols approved by the Institutional Review Conirnittee for registration with the Department of Clinical Investigation durmg Fiscal Year 1997, and other know publications and presentations by the Dwight David Eisenhower Army Medial Center professional staff. A detail sheet of each protocol giving the objective, technical approach, and program is presented.

Subject report identifies the research activities conducted at William Beaumont Army Medical Center by investigators who had protocols approved by the Institutional Review Board and the Institutional Animal Care and Use Committee. This report includes all protocols registered within the Department Of Clinical Investigation during FY 1995. All known presentations and publications are also included. The research protocols described were conducted under the provisions Of AR 4O-38 (Clinical Investigation Program); AR 40-7 (Use Of Investigational Drugs in Humans and the Use Of Schedule I Controlled Substances); AR 70-25 (Use Of Volunteers as Subjects for Research); HSC 40-23 (Management of Clinical Investigation Protocols and Reports); and AR 70-18 (The Use of Animals in DoD Programs).

Subject report identifies the research activities conducted by Tripler Army Medical Center investigators through protocols approved by the Clinical Investigation/Human Use Committees, the Institutional Animal Care and Use Committee, and the Institutional Review Board. The research protocols described were conducted under the provisions of AR 4038 (Clinical Investigation Program); AR 407 (Use of Investigational Drugs in Humans and the Use of Schedule I Controlled Drug Substances; AR 70-25 (Use of Volunteers as Subjects of Research); HSC Reg 4023 (Management of Clinical Investigations Protocols and Reports); and AR 70-18 (me Use of Animals in DOD Programs).

Subject report identifies the research activities conducted at William Beaumont Army Medical Center by investigators who had protocols approved by the Institutional Review Board and the Institutional Animal Care and Use Committee. This report includes all protocols registered within the Department of Clinical Investigation during FY 1995. All known presentations and publications are also included. The research protocols described were conducted under the provisions of AR 40-38 (Clinical Investigation Program); AR 40-7 (Use of Investigational Drugs in Humans and the Use of Schedule I Controlled Substances); AR 70-25 (Use of Volunteers as Subjects for Research); HSC 40-23 (Management of Clinical Investigation Protocols and Reports); and AR 70-18 (The Use of Animals in DoD Programs).

Subject report identifies the research activities conducted at William Beaumont Army Medical Center by investigators who had protocols approved by the Institutional Review Board and the Institutional Animal Care and Use Committee. This report includes all protocols registered within the Department of Clinical Investigation during FY 1995. All known presentations and publications are also included. The research protocols described were conducted under the provisions of AR 40-38 (Clinical Investigation Program); AR 40-7 (Use of Investigational Drugs in Humans and the Use of Schedule I Controlled Substances); AR 70-25 (Use of Volunteers as Subjects for Research); HSC 40-23 (Management of Clinical Investigation Protocols and Reports); and AR 70-18 (The Use of Animals in DoD Programs).

During this period of activity, we published our first comprehensive journal article from results in this project: see Proceedings of the National Academy of Sciences 92:397-401, 1995 (attached). A no-cost extension of the project was approved to extend activities to 31 Aug 96. At the ECU performance site, four trials of hemostatic efficacy of our rehydrated lyophilized platelet preparations were carried out in live pigs according to the Letterman Army Institute animal model of hemorrhagic shock. The results were quite variable and showed the need to adapt this model to emphasize the role of platelets and control other physiologic parameters related to the effects of hypovolemic shock. Attempts in vitro to load rehydrated platelets with calcium ion flux indicator dyes were finally successful, and studies are now underway to measure the responsiveness of these platelet preparations to thrombin and other agonists that rely on Ca2+ for signal transduction. Experiments conducted at UNC showed serotonin uptake and release by rehydrated platelets and surface-related changes in activation. It will be important to continue to define the extent of activation and its control in our rehydrated lyophilized platelet preparations.

This report identifies approved clinical research activities conducted at Walter Reed Army Medical Center through protocols approved by the Clinical Investigation Committee (CIC), the Human Use Committee/Institutional Review Board (HUC/IRB), and the institutional Laboratory Animal Care and Use Committee (lACUC), as appropriate. This report includes a Detail Summary Sheet outlining the progress of each protocol during Fiscal Year 94. Also included is a list of all known presentations and publications related to approved studies, as well as an addendum listing presentations and publications not related to approved clinical investigations. All research was conducted under the provisions of AR 40-38 (Clinical Investigation Program), AR 4O-% (Use of Investigational Drugs in Humans and the Use of Schedule I Controlled Drug Substances), AR 70-25 (Use of Volunteers as Subjects of Research), HSC Regulation 40-23 (Management of Clinical Investigations, Protocols, and Reports), and AR 70-18 (The Use of Animals in DOD Programs)., See also Volume 2. ADA296510

This report identifies approved clinical research activities conducted at Walter Reed Army Medical Center through protocols approved by the Clinical Investigation Committee, the Human Use Committee/Institutional Review Board, and/or the Animal Use Committee, as appropriate. This report includes a Detail Summary Sheet outlining the progress of each protocol during Fiscal Year 93. Also included is a list of all known presentations and publications related to approved studies, as well as those not related to approved clinical investigation protocols. All research was conducted under the provisions of AR 40-38 (Clinical Investigation Program), AR 40-7 (Use of Investigational Drugs in Humans and the Use of Schedule I Controlled Drug Substances), AR 70-25 (Use of Volunteers as Subjects of Research), HSC Reg 40-23 (Management of Clinical Investigations, Protocols, and Reports), and AR 70-18 (The Use of Animals in DOD Programs).

This report covers all research protocols that were administratively or technically supported by the Department of Clinical Investigation, Madigan Army Medical Center, during FY 94. Included in the individual reports are title, investigators, funding, objective, technical approach, and progress for FY 94. Also included in the report are personnel rosters for the Department, funding information, and presentations and publications emanating from Madigan Army Medical Center during FY 94.

This report identifies approved clinical research activities conducted at Womack Army Medical Center through protocols approved by the Clinical Investigation and Human Use Committee/Institutional Review Board. This report includes a Detail Summary Sheet outlining the progress of each protocol during Fiscal Year 94. Also included is a list of all known presentations and publications by Womack Army Medical Center professional staff. All research was conducted under the provisions of AR 40-38 (Clinical Investigation Program), AR 40-7 (Use of Investigational Drugs in Humans and the Use of Schedule I Controlled Drug Substances), AR 70-25 (Use of Volunteers as Subjects of Research) and HSC Reg 40-23 (Management of Clinical Investigations, Protocols and Reports).

Subject report identifies the research activities conducted by Brooke Army Medical Center investigators through protocols approved by the Clinical Investigation Committee, the Institutional Review Board, and the Animal Use Committee for registration with the Department of Clinical Investigation during Fiscal Year 1994, and known publications and presentations by the Brooke Army Medical Center professional staff. A detail sheet of each protocol giving the objective, technical approach and progress is presented., ADA292827

ADA292826

Subject report identifies the research activities conducted by Dwight David Eisenhower Army Medical Center investigators through protocols approved by the Institutional Review Committee for registration with the Department of Clinical Investigation during Fiscal Year 1994, and other known publications and presentations by the Dwight David Eisenhower Army Medical Center professional staff. A detail sheet of each protocol giving the objective, technical approach, and program is presented.

Subject report identifies the research activities conducted by Dwight David Eisenhower Army Medical Center investigators through protocols approved by the Institutional Review Committee for registration with the Department of Clinical Investigation during Fiscal Year 1993, and other known publications and presentations by the Dwight David Eisenhower Army Medical Center professional staff. A detail sheet of each protocol giving the objective, technical approach, and progress is presented.

Subject report identifies those individuals who are conducting investigative protocols at Tripler Army Medical Center. An abstract of each project giving abbreviated technical objectives, methods, and progress is presented. Effects of Des-Leu Angiotensin I, Cortisol, and Hyperbaria on the Release of Vasopressin from the Isolated Hypothalamoneurohypophyseal System; The Metabolic Clearance of Arginine Vasopressin in the Amniotic Sac of the Fetal Guinea Pig; Stop-Flow Analysis of Sodium Entry and Tubular Transit Times for Sodium and Inulin in Normal and Nephrotic Rats; Effects of Hypoxia on the Vasopressin Response to Hemorrhage and its Role in the Maintenance on Blood Pressure.

This report identifies those individuals who are conducting investigative protocols at Tripler Army Medical Center. An abstract of each project giving abbreviated technical objectives, methods, and progress is presented. Departments involved in this research include: Clinical Investigation; Dentistry; Medicine; Obstetrics and Gynecology; Pediatrics; Psychiatry; Surgery; Directorate of Nutrition Care; Pharmacy Service; Oncology; Family Practice; Radiology.

CATALOGERS: report date should be 1989 and dates covered should be 1989.