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1.
Int J Hematol Oncol Stem Cell Res ; 17(3): 167-176, 2023 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-37817974

RESUMO

Background: The coronavirus disease 2019 (COVID-19) outbreak has led to an alteration in hygienic conditions. In this situation, improving standard operating procedures (SOPs) in blood donation centers is critical. The purpose of this study was the assessment of SOPs in the blood donation centers during the outbreak of COVID-19 by regular blood donors as external audits. Materials and Methods: Regular donors were selected as external inspectors in 31 provinces of Iran. The questionnaire containing 10 closed questions was provided to assess the hygienic SOPs of blood transfusion centers in the prevention of COVID-19 transmission. Comparison and evaluation of questionnaires were conducted by assigning an importance coefficient (IC) score to each question. Results: Assessment of SOPs in blood donation departments by regular donors in 31 provinces of Iran showed that 18 centers (58.1%) received IC scores >10(Strong performance), seven centers (22.6%) received the range of IC scores between7-10(acceptable performance), and six centers (19.4%) received IC scores <7(poor performance). The difference in IC scores between provinces was not statistically significant. Conclusion: This study confirms that the assessment of blood donation centers through regular blood donor inspection is a reliable method to identify the strengths and weaknesses of blood transfusion center services and ultimately leads to corrective intervention and improvement of hygienic SOPs to prevent COVID-19 transmission.

2.
China Medical Equipment ; (12): 210-213, 2023.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-1026432

RESUMO

The standard operating procedure(SOP)for cleaning,disinfection and sterilization equipment was established and implemented by combing the operation procedures of equipment manufacturers for cleaning,disinfection and sterilization,and the equipment manufacturer's instructions for reprocessing the equipment with the technical operating specifications of the Rules for Hospital central sterile supply department(WS310.2-2016).480 pieces of cleaning and disinfection equipment,120 pieces of paper-plastic packaging items and 480 pieces sterilized items under regular monitoring in the hospital before and after the implementation of SOP were compared to obtain data of unqualified articles with respect to cleaning,disinfection,package check and sterilization quality monitoring caused by equipment operation quality.The results showed that after the implementation of SOP,the unqualified rate of cleaning and disinfection,inspection and package,periodic sterilization monitoring related to equipment operation was significantly reduced,the difference was statistically significant(x2=29.427,x2=7.206,x2=24.174;P<0.05).The establishment and application of SOP standardizes the operator's operating behavior and effectively reduces the risk of nosocomial infection caused by equipment operation;it can be used in conjunction with the corresponding scoring standards for professional and technical assessment and continuous quality improvement.

3.
JHEP Rep ; 3(4): 100296, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34222850

RESUMO

BACKGROUND & AIMS: Chronic hepatitis B is an incurable disease. Addressing the unmet medical need for therapies has been hampered by a lack of suitable cell culture models to investigate the HBV life cycle in a single experimental setup. We sought to develop a platform suitable to investigate all aspects of the entire HBV life cycle. METHODS: HepG2-NTCPsec+ cells were inoculated with HBV. Supernatants of infected cells were transferred to naïve cells. Inhibition of infection was determined in primary and secondary infected cells by high-content imaging of viral and cellular factors. Novel antivirals were triaged in cells infected with cell culture- or patient-derived HBV and in stably virus replicating cells. HBV internalisation and target-based receptor binding assays were conducted. RESULTS: We developed an HBV platform, screened 2,102 drugs and bioactives, and identified 3 early and 38 late novel HBV life cycle inhibitors using infectious HBV genotype D. Two early inhibitors, pranlukast (EC50 4.3 µM; 50% cytotoxic concentration [CC50] >50 µM) and cytochalasin D (EC50 0.07 µM; CC50 >50 µM), and 2 late inhibitors, fludarabine (EC50 0.1 µM; CC50 13.4 µM) and dexmedetomidine (EC50 6.2 µM; CC50 >50 µM), were further investigated. Pranlukast inhibited HBV preS1 binding, whereas cytochalasin D prevented the internalisation of HBV. Fludarabine inhibited the secretion of HBV progeny DNA, whereas dexmedetomidine interfered with the infectivity of HBV progeny. Patient-derived HBV genotype C was efficiently inhibited by fludarabine (EC50 0.08 µM) and dexmedetomidine (EC50 8.7 µM). CONCLUSIONS: The newly developed high-content assay is suitable to screen large-scale drug libraries, enables monitoring of the entire HBV life cycle, and discriminates between inhibition of early and late viral life cycle events. LAY SUMMARY: HBV infection is an incurable, chronic disease with few available treatments. Addressing this unmet medical need has been hampered by a lack of suitable cell culture models to study the entire viral life cycle in a single experimental setup. We developed an image-based approach suitable to screen large numbers of drugs, using a cell line that can be infected by HBV and produces large amounts of virus particles. By transferring viral supernatants from these infected cells to uninfected target cells, we could monitor the entire viral life cycle. We used this system to screen drug libraries and identified novel anti-HBV inhibitors that potently inhibit HBV in various phases of its life cycle. This assay will be an important new tool to study the HBV life cycle and accelerate the development of novel therapeutic strategies.

4.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-908857

RESUMO

Objective:To investigate the application value of standard operation procedure (SOP) of thoracentesis in clinical skills training for undergraduates.Methods:In this study, 63 undergraduates were randomized into two groups, with 29 students in experimental group receiving SOP training, and 34 students in control group trained by traditional teaching methods. The performance of the two groups at different stages of thoracentesis were compared after the training. SPSS 19.0 was used to analyze the assessment data.Results:The experimental group was significantly superior to the control group in the stages of "puncture operation" and "post-puncture operation" [(33.76±2.46) points vs. (31.91±3.60) points, P=0.02; (7.93±1.53) points vs. (6.79±1.84) points, P=0.01], as well as the total scores [(82.59±4.14) points vs. (79.26±4.94) points, P=0.01]. Conclusion:It's suggested that application of SOP may improve the effectiveness of thoracentesis training, and organized teaching methods are essential for clinical skills training.

5.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-912844

RESUMO

Clinical data is one of the key sources of real-world data, while the reliability of such data is often hindered by unscientific and irregular data management. Based on various problems found in the application of clinical data to scientific research, this study formulated a standard operation procedure(SOP) for real-world data management, and organized the data in terms of content and logic consistency, completeness and standardization. The clinical data of syphilis at a tertiary hospital were used as an example for verification. The clinical data of syphilis patients in the dermatology department from January 1, 2008 to January 1, 2018 were derived from the basic information database, diagnosis database, laboratory information database, and treatment information database of its hospital information system, and a total of 71 705 pieces of relevant information were extracted. SOP analysis showed that 6 816 articles were completely repeated. There were content or logical inconsistencies in name, medical identification number, resident ID number, age and gender, being 152, 360, 88, 107 and 457 respectively. There were many missing entries for marital status, ethnicity, gender, birthday, and ID number, being 1 711, 1 077, 457, 496 and 355 respectively. The standardization situation was generally good, and the number of irregularities in filling out occupational items was 1 884. The standardized and collated data could effectively count the proportion of patients in different stages of syphilis and the cost of diagnosis and treatment, indicating that the real-world data management and analysis SOP proposed in this study could be used to build a clinical-research oriented dual-functional database based on medical practice data.

6.
Organ Transplantation ; (6): 121-2020.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-781866

RESUMO

Liver transplantation has become the most effective treatment of end-stage liver disease. Nursing care for enhanced recovery is safe and effective in the management after liver transplantation, which is conducive to the early recovery of body function of the recipients. In this article, relevant literature review was conducted to summarize the standard operation procedure (SOP) of nursing care for enhanced recovery after liver transplantation from the postoperative vital signs and fluid temperature management, gastrointestinal function and nutrition management, early grading activities, sedation, analgesia and sleep management, infection prevention and control, etc.

7.
Mil Med Res ; 6(1): 39, 2019 12 13.
Artigo em Inglês | MEDLINE | ID: mdl-31831044

RESUMO

BACKGROUND: Snakebites can lead to lifelong consequences and is one of the main causes of death among military troops worldwide. However, few Chinese military medics know the proper first aid procedures for snakebites. Therefore, this study aimed to explore the impact of the Standard Operation Procedure (SOP) and checklist on Chinese military medics' ability to manage snakebite first aid. METHODS: This study was a prospective single-blind randomized controlled trial conducted in a military medical university of China from May to June 2017. A questionnaire-based survey was performed to collect the participants' socio-demographic profiles before the baseline measurement. During the baseline measurement, participants were requested to provide corresponding first aid that was responsive to the simulative situation portrayed by the SPs (standardized patients) and the evaluators then scored their performances according to a checklist for snakebite first aid scoring table. After the baseline measurement, they were randomly assigned to one of three intervention groups after stratification according to their baseline performance scores: group A received a self-learning course with textbooks (n = 27), group B received a self-learning training on the SOP and checklist (n = 27) and group C was engaged in an interactive discussion panel regarding the SOP and checklist (n = 26). After the interventions, participants received outcome measurements about snakebite first aid key points capability from the same evaluator and SP for each group to avoid observational error. The reviewers were blinded about the grouping in the trial. RESULTS: The baseline measurement yielded no significant difference (H = 1.647, P = 0.439) among the three groups. The post-intervention scores were higher than the pre-intervention scores for all three (A, B and C) groups (P = 0.008, P < 0.001 and P < 0.001, respectively). There was significant difference of the post-intervention scores among the three groups (F = 8.841, P < 0.001). Both post-intervention scores of group B and group C were higher than that of group A (P < 0.001 and P = 0.001, respectively), but no difference was found between group B and C (P = 0.695). The acceptance questionnaire score of SOP and checklist was mostly very satisfied, as the final scores of group B and group C were 4.62 ± 0.61 and 4.82 ± 0.45, respectively. CONCLUSIONS: In this study, the implementation of an SOP and checklist for snakebite first aid was shown to update and improve first aid treatment concepts in military medics. These intervention methods played an important role in improving the medics' cognition and understanding of snakebite first aid. Therefore, this finding suggests that SOP and checklist training should be further implemented in Chinese troops for snakebite care.


Assuntos
Primeiros Socorros/métodos , Primeiros Socorros/normas , Militares/educação , Mordeduras de Serpentes/terapia , Adulto , Lista de Checagem , China , Feminino , Humanos , Masculino , Estudos Prospectivos , Método Simples-Cego , Inquéritos e Questionários , Adulto Jovem
8.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-807836

RESUMO

Objective@#To investigate the present situation about the best evidence communication and application of blood specimen collection.@*Methods@#A total of 312 nurses from Zhongshan Hospital Affiliated to Fudan University were investigated with self-designed questionnaire.@*Results@#The scores of the best evidence knowledge of blood specimen collection was 15.23±2.45, 1.9% (6/312) nurses obtained full score. The scores of the best evidence behavior of blood specimen collection was 38.11±2.93, 1.6% (5/312) nurses got full score.@*Conclusions@#The nursing staff had a poor knowledge in the best evidence of blood specimen collection. There was a gap between the best evidence of blood specimen collection and clinical practice. The state of communication and application of the best evidence of blood specimen collection is not good.

9.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-838281

RESUMO

Objective To develop an integrated standard operation procedure (SOP) for in-hospital emergency care of severe acute pancreatitis (SAP), and to explore the clinical application value. Methods We designed an integrated SOP for in-hospital emergency care of SAP by consulting some experts from emergency intensive care unit (ICU) quality control centers in Shanghai, referencing relevant literature and SAP guidelines at home and abroad, and considering the clinical practice and the experience gained in the integration of “emergency-ICU” contraction at Changzheng Hospital of Navy Medical University (Second Military Medical University). Forty-two SAP patients meeting the SOP criteria, who were admitted to Department of Emergency of Changzheng Hospital of Navy Medical University (Second Military Medical University) between Jul. 2015 and Jan. 2017, were included and set as optimization group. Forty SAP patients, who were admitted to the Department of Emergency between Jan. 2014 and Jun. 2015, were set as routine group. Clinical data of the patients were compared between the two groups, including treatment efficiency, white blood cell count, neutrophil ratio, C-reactive protein level, procalcitonin level, blood amylase level, blood glucose level, blood lactic acid level, serum creatinine level, oxygenation index, modified CT severity index (MCTSI) score, intra-abdominal pressure, urinary neutrophil gelatinase-associated lipocalin (NGAL) level and acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score on 72 h and 1 week after admission, complications and survival. Results The proposed SOP mainly referred to the international standard for diagnosis and treatment of SAP in 2012. The updates were mainly in the emergency first visit and comprehensive treatment scheme. In the former, the emergency surgery doctor was changed to emergency green channel (resuscitation room). In the latter, several clinical protocols were added, such as intrarenous injection of a large dose of ulinastatin, rapid infusion of human albumin (intravenous injection of furosemidum when necessary), standardized full-thatch mirabilite external application and coloclysis of sterile solution of rheum officinale. Compared with the routine group, the total rate of treatment efficiency was significantly better, and hospital stay, exhaust recovery time, bloating relief time, ICU duration time, and continuous renal replacement therapy time were significantly shorter in the optimization group (all P0.05). There were significant differences in the white blood cell count, neutrophil ratio, oxygenation index, MCTSI score and intra-abdominal pressure and the levels of C-reactive protein, procalcitonin, blood glucose, lactic acid, serum creatinine, urinary NGAL on 72 h and 1 week after admission between the two groups (all P0.05). The levels of blood amylase were significantly different between the two groups on 72 h after admission (P0.01). The incidences of acute renal failure, acute respiratory distress syndrome, ascites, abdominal compartment syndrome, pancreatic pseudocyst and pancreatic abscess were significantly lower in the optimization group than those in the routine group (all P0.05). Compared with the routine group, the survival time was significantly longer and the survival rate within two months was significantly higher in optimization group (P0.05). Conclusion The proposed in-hospital integrated emergency SOP can standardize the diagnosis and treatment process of SAP, improve the efficiency of treatment, and reduce mortality of patients.

10.
Chinese Journal of Nursing ; (12): 1033-1037, 2017.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-660543

RESUMO

Objective To explore the effects of application of standard operation procedure (SOP) for perioperative nursing in children with developmental dislocation of the hip (DDH).Methods From March to September 2015,a total of 59 children with DDH were provided SOP for perioperative nursing.We retrospectively analyzed 50 cases of children with DDH treated with routine perioperative nursing admitted between June 2014 and December 2014.We compared the completeness of preoperative preparation,the incidence of postoperative complications and the parental satisfaction between two groups.Results Application of SOP for perioperative nursing increased the completeness of preoperative preparation,decreased the incidence of postoperative complications,and the parental satisfaction was greatly improved.Conclusion SOP for perioperative nursing for children with DDH can standardize nurses' working procedure,making nursing practice procedure much more specific,specified and clear,and can better guide clinical practice.

11.
Chinese Journal of Nursing ; (12): 1033-1037, 2017.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-662689

RESUMO

Objective To explore the effects of application of standard operation procedure (SOP) for perioperative nursing in children with developmental dislocation of the hip (DDH).Methods From March to September 2015,a total of 59 children with DDH were provided SOP for perioperative nursing.We retrospectively analyzed 50 cases of children with DDH treated with routine perioperative nursing admitted between June 2014 and December 2014.We compared the completeness of preoperative preparation,the incidence of postoperative complications and the parental satisfaction between two groups.Results Application of SOP for perioperative nursing increased the completeness of preoperative preparation,decreased the incidence of postoperative complications,and the parental satisfaction was greatly improved.Conclusion SOP for perioperative nursing for children with DDH can standardize nurses' working procedure,making nursing practice procedure much more specific,specified and clear,and can better guide clinical practice.

12.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-665517

RESUMO

By formulating the standard operating procedures for clinical skills, and standardizing the operation steps, the Affiliated Hospital of Inner Mongolia Medical University further refines and quantifies the scoring criteria, and this is also applied in the teaching practice of medical students' clinical skills. The two operations of clean wound dressing and diagnostic peritoneal puncture are taken as an example for description. The assessment results shows that the level of medical students' clinical skills has improved significantly. Questionnaire survey also shows that teachers' training efficiency and students' learning effi-ciency have been improved , indicating that clinical skills standard operation procedures have achieved good teaching results in clinical skills teaching practice.

13.
Front Microbiol ; 7: 532, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27199898

RESUMO

Hydrogenotrophic methanogens are an intriguing group of microorganisms from the domain Archaea. Methanogens exhibit extraordinary ecological, biochemical, and physiological characteristics and possess a huge biotechnological potential. Yet, the only possibility to assess the methane (CH4) production potential of hydrogenotrophic methanogens is to apply gas chromatographic quantification of CH4. In order to be able to effectively screen pure cultures of hydrogenotrophic methanogens regarding their CH4 production potential we developed a novel method for indirect quantification of the volumetric CH4 production rate by measuring the volumetric water production rate. This method was established in serum bottles for cultivation of methanogens in closed batch cultivation mode. Water production was estimated by determining the difference in mass increase in a quasi-isobaric setting. This novel CH4 quantification method is an accurate and precise analytical technique, which can be used to rapidly screen pure cultures of methanogens regarding their volumetric CH4 evolution rate. It is a cost effective alternative determining CH4 production of methanogens over CH4 quantification by using gas chromatography, especially if applied as a high throughput quantification method. Eventually, the method can be universally applied for quantification of CH4 production from psychrophilic, thermophilic and hyperthermophilic hydrogenotrophic methanogens.

14.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-508769

RESUMO

Objective To discuss the application and effect evaluation of the standard operation procedure ( SOP ) teaching method during applying surgical practice teaching in local medical college . Method 123 undergraduate students from Grade 2011 clinical medical major in Medical College of Shaoguan University were selected as objects of study. The students were divided into test (odd) group and control (even) group by draw. The two groups were taught by the same teachers, while the SOP method was applied to the test group (n=62) and the traditional surgical clinical teaching method was applied to the control group (n=61). Meanwhile, we used a combined method of the formative assessment and final assess-ment to compare and analyze the teaching feedback. After their graduate internship, we compared their autonomous study capability, clinical evaluation thought, normativity of the operation and capability in their intern positions as well as the degree of satisfaction of the test of two groups by doing a survey among them. All these were analyzed by SPSS 18.0 software, and t test was used to compare two groups' measurement in-formation and count data with chi-square. Results The comprehensive evaluation scores of the test group were significantly higher than the control group, in which the margin was of statistical value [(79.394 ± 8.049) vs. (71.703±10.462), t=39.632, P=0.000]. The percentage of excellence of the test group was signif-icantly higher than the control group, in which the margin was of statistical value (59.68% vs. 39.35%, χ2=5.082, P=0.024). The percentage of failure of the test group was lower than the group taught by the tradi-tional method, in which the margin was of statistical value (3.22%vs. 16.39%, χ2=4.652, P=0.031). Its for-mative assessment result on the evaluation of the experimental teaching process and summative assessment scores were higher than the control group, and the difference was statistically significant [formative scores points: (46.018 ±5.749) vs. (42.771 ±6.459), t=19.445, P=0.000; summative scores: (33.659 ±3.437) vs. (29.063±4.366), t=36.249, P=0.000]. As far as their clinical graduate internship adaptation capabilities were concerned, students from the test group had more satisfaction on the teaching feedback over 4 perspectives than the other group, in which the margin was of statistical value. Experimental groups' satisfaction showed that: 93.55% of students thought the standard operation procedure (SOP) teaching method was beneficial to improving their clinical practice skills, 91.94%thought that it improved their surgical clinical work ability to adapt, 85.48% thought it helped to cultivate their surgical clinical thinking and innovation ability. Conclusions The SOP teaching method in surgical practice teaching helps to enhance students' clinical operation and adaptation capability and promote the teaching quality.

15.
J Nutr Biochem ; 26(5): 505-12, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25704478

RESUMO

The detection of exogenous plant microRNAs in human/animal plasma/sera lies at the foundation of exploring their cross-kingdom regulatory functions. It is necessary to establish a standard operation procedure to promote study in this nascent field. In this study, 18 plant miRNAs were assessed in watermelon juice and mixed fruits by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR). CT values, no-template controls and standard curves for each miRNA were used to evaluate the specificity and sensitivity of qRT-PCR and to obtain concentrations. Sixteen miRNAs were selected and measured in human plasma from volunteers after drinking juice. The CT values of 6 plant miRNAs in human plasma fell outside the linear ranges of their standard curves. The remaining 10 miRNAs were present at high basal levels, and 6 of them showed a dynamic physiological pattern in plasma (absorption rates of 0.04% to 1.31%). Northern blotting was used to confirm the qRT-PCR results. Critical issues such as RNA extraction and internal controls were also addressed.


Assuntos
MicroRNAs/sangue , Plantas/genética , RNA de Plantas/sangue , Northern Blotting , Humanos , MicroRNAs/administração & dosagem , Reação em Cadeia da Polimerase Via Transcriptase Reversa
16.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-470076

RESUMO

Objective To standardize the operation processes of neonatal instrument,ensure the standards effectiveness and safety of equipment use.Methods A retrospective study had been taken on after the developments and implementations of all neonatal instruments standard operation procedure (SOP).The equipment maintenance data were collected and analyzed one year before and after the implementation of SOP.Results After the effective implementation of the SOP,the incidence of instrument repair due to misoperation,improper maintenance reduad by 59%(19/32),9/14,4/7,the instrument management efficiency was enhanced,and the safety of nurses and patients was guaranteed,and the patients satisfaction was improved,and also the quality of care was enhanced.Conclusions SOP procedure plays a very important role in improving neonatal care management and overall efficiency.It makes a continuous improvement of nursing care which is worth widely being implemented.

17.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-466843

RESUMO

Objective We sought to establish the standard operation procedures in department of cardiology.Methods According to the method of constructing standard operation procedures,the standard operation procedures for the department of cardiology was constructed through induction and consulting literature materials.Results 16 standard operation procedures for the department of cardiology were developed,including 8 SOP of common diseases to rescue,2 SOP of common operation in perioperative period,4 SOP for common instruments,2 SOP for common drugs usage.Conclusions Construction of standard operation procedures in department of cardiology can provide the basis for clinical nursing work,it can also supply methodological reference to build the standard operation procedures in other departments.

18.
Int J Hyg Environ Health ; 217(2-3): 312-22, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23928002

RESUMO

The objective of COPHES (Consortium to Perform Human biomonitoring on a European Scale) was to develop a harmonised approach to conduct human biomonitoring on a European scale. COPHES developed a systematic approach for designing and conducting a pilot study for an EU-wide cross-sectional human biomonitoring (HBM) study and for the implementation of the fieldwork procedures. The approach gave the basis for discussion of the main aspects of study design and conduct, and provided a decision making tool which can be applied to many other studies. Each decision that had to be taken was listed in a table of options with their advantages and disadvantages. Based on this the rationale of the decisions could be explained and be transparent. This was important because an EU-wide HBM study demands openness of all decisions taken to encourage as many countries as possible to participate and accept the initiative undertaken. Based on this approach the following study design was suggested: a cross-sectional study including 120 children aged 6-11 years and their mothers aged up to 45 years from each participating country. For the pilot study the children should be sampled in equal shares in an urban and a rural location. Only healthy children and mothers (no metabolic disturbances) should be included, who have a sufficient knowledge of the local language and have been living at least for 5 years at the sampling location. Occupational exposure should not be an exclusion criterion. Recruitment should be performed via inhabitant registries or schools as an alternative option. Measures suitable to increase the response rate should be applied. Preferably, the families should be visited at home and interviewed face-to-face. Various quality control measures to guarantee a good fieldwork performance were recommended. This comprehensive overview aims to provide scientists, EU officials, partners and stakeholders involved in the EU implementation process full transparency of the work carried out in COPHES. Thus this report presents the discussion and consensus in COPHES on the main aspects of designing and conducting fieldwork of a human biomonitoring study. Furthermore, it provides an example for a systematic approach that may be useful to other research groups or pan-European research initiatives. In the study protocol that will be published elsewhere these aspects are elaborated and additional aspects are covered (Casteleyn et al., 2012). Meanwhile the respective pilot study DEMOCOPHES had been conducted and assessed. The results and lessons learned will be published elsewhere.


Assuntos
Exposição Ambiental/análise , Monitoramento Ambiental/métodos , Poluentes Ambientais/análise , Projetos de Pesquisa , Adulto , Criança , Consenso , Estudos Transversais , Tomada de Decisões , Europa (Continente) , Feminino , Humanos , Masculino , Mães , Projetos Piloto
19.
Vaccine ; 31(47): 5602-20, 2013 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-23499603

RESUMO

This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts.


Assuntos
Pesquisa Biomédica/métodos , Ensaios Clínicos como Assunto , Vacinas/efeitos adversos , Humanos , Vacinas/administração & dosagem
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