Guideline for radioimmunotherapy of rituximab relapsed or refractory CD20+ follicular B-cell nonHodgkin´s lymphoma

2004 ◽  
Vol 43 (05) ◽  
pp. 171-176 ◽  
Author(s):  
T. Behr ◽  
F. Grünwald ◽  
W. H. Knapp ◽  
L. Trümper ◽  
C. von Schilling ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Management ◽  
Medical Physics ◽  
Essential Elements ◽  
Background Information ◽  
After Care ◽  
Complete Treatment ◽  
Close Cooperation ◽  
Work Up

Summary:This guideline is a prerequisite for the quality management in the treatment of non-Hodgkin-lymphomas using radioimmunotherapy. It is based on an interdisciplinary consensus and contains background information and definitions as well as specified indications and detailed contraindications of treatment. Essential topics are the requirements for institutions performing the therapy. For instance, presence of an expert for medical physics, intense cooperation with all colleagues committed to treatment of lymphomas, and a certificate of instruction in radiochemical labelling and quality control are required. Furthermore, it is specified which patient data have to be available prior to performance of therapy and how the treatment has to be carried out technically. Here, quality control and documentation of labelling are of greatest importance. After treatment, clinical quality control is mandatory (work-up of therapy data and follow-up of patients). Essential elements of follow-up are specified in detail. The complete treatment inclusive after-care has to be realised in close cooperation with those colleagues (haematology-oncology) who propose, in general, radioimmunotherapy under consideration of the development of the disease.

Guideline for radioimmunotherapy of CD20+ follicular B-cell non-Hodgkin's lymphoma

2009 ◽  
Vol 48 (06) ◽  
pp. 215-220
Author(s):  
F. Grünwald ◽  
W. H. Knapp ◽  
L. Trümper ◽  
C. v. Schilling ◽  
M. Dreyling ◽  
...  
Keyword(s):  
Quality Control ◽  
Medical Physics ◽  
Essential Elements ◽  
Background Information ◽  
After Care ◽  
Complete Treatment ◽  
First Remission ◽  
Close Cooperation ◽  
Work Up

SummaryThis guideline is a prerequisite for the quality management in the treatment of non-Hodgkon-lymphomas in patients with relapsed or refractory follicular lymphoma after rituximab therapy and as consolidation therapy after first remission following CHOP like treatment using radioimmunotherapy. It is based on an interdisciplinary consensus and contains background information and definitions as well as specified indications and detailed contraindications of treatment. Essential topics are the requirements for institutions performing the therapy. For instance, presence of an expert for medical physics, intense cooperation with all colleagues committed to treatment of lymphomas, and a certificate of instruction in radiochemical labelling and quality control are required. Furthermore, it is specified which patient data have to be available prior to performance of therapy and how treatment has to be carried out technically. Here, quality control and documentation of labelling are of great importance. After treatment, clinical quality control is mandatory (work-up of therapy data and followup of patients). Essential elements of follow-up are specified in detail. The complete treatment inclusive after-care has to be realised in close cooperation with those colleagues (hemato-oncologists) who propose, in general, radioimmunotherapy under consideration of the development of the disease.

scholarly journals The use of dried tube specimens of Plasmodium falciparum in an external quality assessment programme to evaluate health worker performance for malaria rapid diagnostic testing in healthcare centres in Togo

2021 ◽  
Author(s):  
Monique Ameyo DORKENOO ◽  
Kafui Codjo Kouassi ◽  
Adjane K. Koura ◽  
Martin L Adams ◽  
Komivi Gbada ◽  
...  
Keyword(s):  
Quality Control ◽  
Plasmodium Falciparum ◽  
Quality Management ◽  
Health Worker ◽  
Health Workers ◽  
Health Centre ◽  
Essential Elements ◽  
Ease Of Use ◽  
Malaria Rdts ◽  
National Quality

Abstract BackgroundThe use of rapid diagnostic tests (RDTs) to diagnose malaria is common in sub-Saharan African laboratories, remote primary health facilities and in the community. Currently, there is a lack of reliable methods to ascertain health worker competency to accurately use RDTs in the testing and diagnosis of malaria. Dried tube specimens (DTS) have been shown to be a consistent and useful method for quality control of malaria RDTs, however, its application in National Quality Management programmes has been limited.MethodsA Plasmodium falciparum strain was grown in culture and harvested to create DTS of varying parasite density (0, 100, 200, 500 and 1,000 parasites/µL). Using the dried tube specimens as quality control material, a proficiency testing (PT) programme was carried out in 80 representative health centres in Togo. Health worker competency for performing malaria RDTs was assessed using five blinded DTS samples, and the DTS were tested in the same manner as a patient sample would be tested by multiple testers per health centre. ResultsAll the DTS with 100 parasites/µl and 50% of DTS with 200 parasites/µl were classified as non-reactive during the pre-PT quality control step. Therefore, data from these parasite densities were not analysed as part of the PT dataset. PT scores across all 80 facilities and 235 testers was 100% for 0 parasites/µl, 63% for 500 parasites/µl and 93% for 1,000 parasites/µl. Overall, 59% of the 80 healthcare centres that participated in the PT programme received a score of 80% or higher on a set of 0, 500 and 1,000 parasites/ µl DTS samples. Sixty percent of health workers at these centres recorded correct test results for all three samples.ConclusionsThe use of DTS for a malaria PT programme was the first of its kind ever conducted in Togo. The ease of use and stability of the DTS illustrates that they this type of samples can be considered for the assessment of staff competency. The implementation of quality management systems, refresher training and expanded PT at remote testing facilities are essential elements to improve the quality of malaria diagnosis.

scholarly journals The use of dried tube specimens of Plasmodium falciparum in an External Quality Assessment program to evaluate health worker performance for malaria rapid diagnostic testing in healthcare centers in Togo

2020 ◽  
Author(s):  
Monique Ameyo DORKENOO ◽  
Kafui Codjo Kouassi ◽  
Adjane K. Koura ◽  
Martin L Adams ◽  
Komivi Gbada ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Management ◽  
Health Worker ◽  
Health Workers ◽  
Diagnostic Testing ◽  
Malaria Diagnosis ◽  
Essential Elements ◽  
Ease Of Use ◽  
Malaria Rdts ◽  
National Quality

Abstract Background: The use of rapid diagnostic tests (RDTs) to diagnose malaria is common in Sub-Saharan African laboratories, remote primary health facilities and in the community. Currently, there is a lack of reliable methods to ascertain health worker competency to accurately use RDTs in the testing and diagnosis of malaria. Dried tube specimens (DTS) have been shown to be a consistent and useful method for quality control of malaria RDTs, however, its application in National Quality Management programs has been limited.Methods: A P. falciparum strain was grown in culture and harvested to create DTS of varying parasite density (0, 100, 200, 500 and 1,000 parasites/µL). Using the dried tube specimens as quality control material, a proficiency testing (PT) program was carried out in 80 representative health centers in Togo. Health worker competency for performing malaria RDTs (mRDTs) was assessed using five blinded DTS samples, and the DTS were tested in the same manner as a patient sample would be tested by multiple testers per health center. Results: All the DTS with 100 parasites/µl and 50% of DTS with 200 parasites/µl were classified as non-reactive during the pre-PT quality control step. Therefore, data from these parasite densities were not analyzed as part of the PT dataset. PT scores across all 80 facilities and 235 testers was 100% for 0 parasites/µl, 63% for 500 parasites/µl and 93% for 1,000 parasites/µl. Overall, 59% of the 80 healthcare centers that participated in the PT program received a score of 80% or higher on a set of 0, 500 and 1,000 parasites/ µl DTS samples. Sixty percent of health workers at these centers recorded correct test results for all three samples. Conclusions: The use of DTS for a malaria PT program was the first of its kind ever conducted in Togo. The ease of use and stability of the DTS illustrates that they this type of samples can be considered for the assessment of staff competency. The implementation of quality management systems, refresher training and expanded PT at remote testing facilities are essential elements to improve the quality of malaria diagnosis.

scholarly journals The use of dried tube specimens of Plasmodium falciparum in an external quality assessment programme to evaluate health worker performance for malaria rapid diagnostic testing in healthcare centres in Togo

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Ameyo M. Dorkenoo ◽  
Kafui Codjo Kouassi ◽  
Adjane K. Koura ◽  
Martin L. Adams ◽  
Komivi Gbada ◽  
...  
Keyword(s):  
Quality Control ◽  
Plasmodium Falciparum ◽  
Quality Management ◽  
Health Worker ◽  
Health Workers ◽  
Health Centre ◽  
Essential Elements ◽  
Ease Of Use ◽  
Malaria Rdts ◽  
National Quality

Abstract Background The use of rapid diagnostic tests (RDTs) to diagnose malaria is common in sub-Saharan African laboratories, remote primary health facilities and in the community. Currently, there is a lack of reliable methods to ascertain health worker competency to accurately use RDTs in the testing and diagnosis of malaria. Dried tube specimens (DTS) have been shown to be a consistent and useful method for quality control of malaria RDTs; however, its application in National Quality Management programmes has been limited. Methods A Plasmodium falciparum strain was grown in culture and harvested to create DTS of varying parasite density (0, 100, 200, 500 and 1000 parasites/µL). Using the dried tube specimens as quality control material, a proficiency testing (PT) programme was carried out in 80 representative health centres in Togo. Health worker competency for performing malaria RDTs was assessed using five blinded DTS samples, and the DTS were tested in the same manner as a patient sample would be tested by multiple testers per health centre. Results All the DTS with 100 parasites/µl and 50% of DTS with 200 parasites/µl were classified as non-reactive during the pre-PT quality control step. Therefore, data from these parasite densities were not analysed as part of the PT dataset. PT scores across all 80 facilities and 235 testers was 100% for 0 parasites/µl, 63% for 500 parasites/µl and 93% for 1000 parasites/µl. Overall, 59% of the 80 healthcare centres that participated in the PT programme received a score of 80% or higher on a set of 0, 500 and 1000 parasites/ µl DTS samples. Sixty percent of health workers at these centres recorded correct test results for all three samples. Conclusions The use of DTS for a malaria PT programme was the first of its kind ever conducted in Togo. The ease of use and stability of the DTS illustrates that this type of samples can be considered for the assessment of staff competency. The implementation of quality management systems, refresher training and expanded PT at remote testing facilities are essential elements to improve the quality of malaria diagnosis.

scholarly journals The Use Of Dried Tube Specimens Of Plasmodium Falciparum In An External Quality Assessment Program To Evaluate Health Worker Performance For Malaria Rapid Diagnostic Testing In Healthcare Centers In Togo

2020 ◽  
Author(s):  
Monique Ameyo Dorkenoo ◽  
Kafui Codjo Kouassi ◽  
Adjane K. Koura ◽  
Martin L Adams ◽  
Komivi Gbada ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Management ◽  
Health Worker ◽  
Health Workers ◽  
Diagnostic Testing ◽  
Malaria Diagnosis ◽  
Essential Elements ◽  
Ease Of Use ◽  
Malaria Rdts ◽  
National Quality

Abstract Background: The use of rapid diagnostic tests (RDTs) to diagnose malaria is common in Sub-Saharan African laboratories, remote primary health facilities and in the community. Currently, there is a lack of reliable methods to ascertain health worker competency to accurately use RDTs in the testing and diagnosis of malaria. Dried tube specimens (DTS) have been shown to be a consistent and useful method for quality control of malaria RDTs, however, its application in National Quality Management programs has been limited. Methods: A P. falciparum strain was grown in culture and harvested to create DTS of varying parasite density (0, 100, 200, 500 and 1,000 parasites/µL). Using the dried tube specimens as quality control material, a proficiency testing (PT) program was carried out in 80 health centers in Togo. Health worker competency for performing malaria RDTs (mRDTs) was assessed using five blinded DTS samples, and the DTS were tested in the same manner as a patient sample would be tested by multiple testers per health center. Results: All the DTS with 100 parasites/µl and 50% of DTS with 200 parasites/µl were classified as non-reactive during the pre-PT quality control step. Therefore, data from these parasite densities were not analyzed as part of the PT dataset. PT scores across all 80 facilities and 235 testers was 100% for 0 parasites/µl, 63% for 500 parasites/µl and 93% for 1,000 parasites/µl. Overall, 59% of the 80 healthcare centers that participated in the PT program received a score of 80% or higher on a set of 0, 500 and 1,000 parasites/ µl DTS samples. Sixty percent of health workers at these centers scored higher than 80%. Conclusions: The use of DTS for a malaria PT program was the first of its kind ever conducted in Togo. The ease of use of the DTS illustrates that they can serve as well-characterized, stable samples to assess staff competency. The implementation of quality management systems, refresher training and expanded PT at remote testing facilities are essential elements to improve the quality of malaria diagnosis.

Autoimmune Pancreatitis – Diagnosis, Management and Longterm Follow-up

2014 ◽  
Vol 23 (2) ◽  
pp. 179-185 ◽  
Author(s):  
Suvadip Chatterjee ◽  
Kofi W. Oppong ◽  
John S. Scott ◽  
Dave E. Jones ◽  
Richard M. Charnley ◽  
...  
Keyword(s):  
Autoimmune Pancreatitis ◽  
Rare Condition ◽  
Team Approach ◽  
Diagnostic Challenge ◽  
Multisystem Disorder ◽  
North East ◽  
The North ◽  
Work Up ◽  
Igg4 Level

Background & Aims: Autoimmune pancreatitis (AIP) is a fibroinflammatory condition affecting the pancreas and could present as a multisystem disorder. Diagnosis and management can pose a diagnostic challenge in certain groups of patients. We report our experience of managing this condition in a tertiary pancreaticobiliary centre in the North East of England.Methods: Patients were identified from a prospectively maintained database of patients diagnosed with AIP between 2005 and 2013. Diagnosis of definite/probable AIP was based on the revised HISORt criteria. When indicated, patients were treated with steroids and relapses were treated with azathioprine. All patients have been followed up to date.Results: Twenty-two patients were diagnosed with AIP during this period. All patients had pancreatic protocol CT performed while some patients had either MR or EUS as part of the work up. Fourteen out of 22 (64%) had an elevated IgG4 level (mean: 10.9 g/L; range 3.4 - 31 g/L). Four (18%) patients underwent surgery. Extrapancreatic involvement was seen in 15 (68%) patients, with biliary involvement being the commonest. Nineteen (86%) were treated with steroids and five (23%) required further immunosuppression for treatment of relapses. The mean follow up period was 36.94 months (range 7 - 94).Conclusion: Autoimmune pancreatitis is being increasingly recognized in the British population. Extrapancreatic involvement, particularly extrahepatic biliary involvement seems to be a frequent feature.Diagnosis should be based on accepted criteria as this significantly reduces the chances of overlooking malignancy. Awareness of this relatively rare condition and a multi-disciplinary team approach will help us to diagnose and treat this condition more efiectively thereby reducing unnecessary interventions.

System errors of manufacturers of medicines detected by conducting of state control in the area of circulation of medicines

2019 ◽  
Vol 2019 (5) ◽  
pp. 32-38
Author(s):  
Валентина Косенко ◽  
Valentina Kosenko ◽  
Алла Трапкова ◽  
Alla Trapkova ◽  
Светлана Тарасова ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Management ◽  
Management Systems ◽  
State Control ◽  
Quality Management Systems ◽  
Conducting State ◽  
Pharmaceutical Quality ◽  
State Quality ◽  
System Errors

The article conducts the analysis of system errors detected by Roszdravnadzor by conducting state quality control of circulating medicines, as well as weaknesses in pharmaceutical quality management systems of the manufacturers, that can influence the quality of manufactured drugs.

scholarly journals The first multicentre study on coronary anomalies in the Netherlands: MuSCAT

2021 ◽  
Author(s):  
C. J. Koppel ◽  
B. W. Driesen ◽  
R. J. de Winter ◽  
A. E. van den Bosch ◽  
R. van Kimmenade ◽  
...  
Keyword(s):  
Coronary Artery ◽  
The Netherlands ◽  
Multicentre Study ◽  
Ct Angiography ◽  
Patient Group ◽  
Care Pathway ◽  
Coronary Anomalies ◽  
Work Up ◽  
Ischaemia Detection

Abstract Background Current guidelines on coronary anomalies are primarily based on expert consensus and a limited number of trials. A gold standard for diagnosis and a consensus on the treatment strategy in this patient group are lacking, especially for patients with an anomalous origin of a coronary artery from the opposite sinus of Valsalva (ACAOS) with an interarterial course. Aim To provide evidence-substantiated recommendations for diagnostic work-up, treatment and follow-up of patients with anomalous coronary arteries. Methods A clinical care pathway for patients with ACAOS was established by six Dutch centres. Prospectively included patients undergo work-up according to protocol using computed tomography (CT) angiography, ischaemia detection, echocardiography and coronary angiography with intracoronary measurements to assess anatomical and physiological characteristics of the ACAOS. Surgical and functional follow-up results are evaluated by CT angiography, ischaemia detection and a quality-of-life questionnaire. Patient inclusion for the first multicentre study on coronary anomalies in the Netherlands started in 2020 and will continue for at least 3 years with a minimum of 2 years of follow-up. For patients with a right or left coronary artery originating from the pulmonary artery and coronary arteriovenous fistulas a registry is maintained. Results Primary outcomes are: (cardiac) death, myocardial ischaemia attributable to the ACAOS, re-intervention after surgery and intervention after initially conservative treatment. The influence of work-up examinations on treatment choice is also evaluated. Conclusions Structural evidence for the appropriate management of patients with coronary anomalies, especially (interarterial) ACAOS, is lacking. By means of a structured care pathway in a multicentre setting, we aim to provide an evidence-based strategy for the diagnostic evaluation and treatment of this patient group.

scholarly journals Living Kidney Donation: Practical Considerations on Setting Up a Program

2021 ◽  
Vol 2 (1) ◽  
pp. 75-86
Author(s):  
Maria Irene Bellini ◽  
Vito Cantisani ◽  
Augusto Lauro ◽  
Vito D’Andrea
Keyword(s):  
Good Practice ◽  
Kidney Donation ◽  
Living Kidney Donation ◽  
Exchange Programs ◽  
Paired Exchange ◽  
Stage Renal Disease ◽  
End Stage ◽  
Additional Value ◽  
Work Up

Living kidney donation represents the best treatment for end stage renal disease patients, with the potentiality to pre-emptively address kidney failure and significantly expand the organ pool. Unfortunately, there is still limited knowledge about this underutilized resource. The present review aims to describe the general principles for the establishment, organization, and oversight of a successful living kidney transplantation program, highlighting recommendation for good practice and the work up of donor selection, in view of potential short- and long-terms risks, as well as the additional value of kidney paired exchange programs. The need for donor registries is also discussed, as well as the importance of lifelong follow up.

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