16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amsterdam

Voor nieuws, actualiteiten en acties specifiek over Lyme-Borreliose.
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Roxy
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Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Za 20 Jul 2024, 18:16

Vervolg op; Bron viewtopic.php?f=5&t=2595&start=310#p29922
..Nieuw bewijs?
Bron https://nl-nl.facebook.com/drrichardhorowitz/ 22 november 2023:..Here it is. The long awaited article :arrow: proving that dapsone combination therapy can eradicate borrelia :arrow: in the mouse model. This is the first animal model to prove dapsone in combination can effectively kill borrelia, as we have seen in our patient studies, and proves persistence....one more time.
Great work Monica and thanks BAL for the support.
This should article should help us to lay the groundwork for a randomized controlled multicenter trial on dapsone...
..'proving that dapsone combination therapy can eradicate borrelia in the mouse model'..?

Is het gestelde juist? Een heldere en duidelijke uitleg over Dieronderzoek - leerzaam artikel van Unbiased Science Podcast; Bron https://www.facebook.com/unbiasedscipod
Vertaald:..Dieronderzoek is van cruciaal belang geweest voor de wetenschappelijke vooruitgang, omdat het inzicht heeft opgeleverd in complexe biologische systemen en gecontroleerde studies naar ziekteprogressie en behandelingen mogelijk heeft gemaakt. Het volgt doorgaans op in-vitro-onderzoeken en dient als een kritisch veiligheidscontrolepunt voorafgaand aan klinische proeven op mensen. Bij de ontwikkeling van geneesmiddelen worden diermodellen gebruikt als een eerste veiligheidssignaal, waarbij onderzoekers nieuwe verbindingen beoordelen op mogelijke toxiciteit of onverwachte risico's. Alleen behandelingen die in dierstudies als veilig worden beschouwd, gaan door naar proeven op mensen. Deze aanpak heeft bijgedragen aan talrijke medische doorbraken, waaronder insuline voor diabetes, vaccins, kankertherapieën en orgaantransplantatietechnieken. Hoewel essentieel voor vooruitgang, wordt dieronderzoek steeds vaker aangevuld met alternatieve methoden om ethische problemen aan te pakken en de menselijke relevantie te vergroten.

Dieronderzoek is echter niet zonder beperkingen. Soortverschillen kunnen tot misleidende resultaten leiden, en het nauwkeurig repliceren van menselijke ziekten bij dieren blijft een uitdaging. Ethische zorgen, hoge kosten en het tijdrovende karakter van dierstudies maken het probleem nog ingewikkelder. Bovendien heeft het potentieel voor slechte vertaalbaarheid naar menselijke resultaten vragen doen rijzen over de efficiëntie van dit onderzoeksmodel.

Als reactie hierop is er een aanzienlijke impuls in de richting van de ontwikkeling van proefdiervrije onderzoeksmodellen, gedreven door het verlangen naar meer voor de mens relevante gegevens en overwegingen op het gebied van dierenwelzijn. Opkomende alternatieven zijn onder meer 3D-celculturen, organoïden, ‘orgaan-op-een-chip’-technologieën, geavanceerde computer-modellering en het gebruik van menselijke weefselmonsters. Deze benaderingen sluiten aan bij het “3V’s”-principe - Replace, Reduce, and Refine - dat tot doel heeft het gebruik van dieren en het lijden in onderzoek tot een minimum te beperken.

De wetenschappelijke gemeenschap richt zich steeds meer op dierenwelzijn en implementeert strengere regelgeving en verbeterde protocollen. Deze verschuiving weerspiegelt een groeiende erkenning van de noodzaak om wetenschappelijke vooruitgang in evenwicht te brengen met ethische verantwoordelijkheden. Naarmate de technologie vordert, evolueert het biomedisch onderzoek, waarbij wordt gestreefd naar efficiëntere, ethische en voor de mens relevante manieren om wetenschappelijke kennis en medische behandelingen te bevorderen..
Science Guide
9 januari 2019
“Het echte probleem is dat we de mens gewoon nog niet zo goed kennen”; Bron https://www.scienceguide.nl/2019/01/het ... ed-kennen/
..“We moeten ons herbezinnen op het werk dat we doen met proefdieren. Dat kan door ons te realiseren dat het proefdier vaak een beroerd model is voor de mens, en door tegelijkertijd onze onderzoeksvragen beter te doordenken.”..

..De fysiologie van :arrow: de muis wordt nooit die van de mens
“Waar we steeds meer achter beginnen te komen is hoe moeilijk het is om de vertaalslag van proefdier naar de menselijke context te maken. :arrow: Te vaak zien we dat resultaten die komen uit proefdieronderzoek niet gereproduceerd kunnen worden in mensen.” Want alhoewel het bijvoorbeeld steeds makkelijker is geworden om dieren genetisch te modificeren zodat ze eigenschappen vertonen die bijvoorbeeld lijken op menselijke ziekten, is dit geen garantie voor de vertaalslag naar de mens.” Elke keer dat je een nieuw diermodel creëert, moet je onderzoeken welke aspecten van de mens dit model nabootst en welke niet”, zo licht Van de Sandt toe.“..

:arrow: En duidelijke reactie van Innatoss Laboratories op 'Comparison of the Efficacy of Longer versus Shorter Pulsed High Dose Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease/Post Treatment Lyme Disease Syndrome with Bartonellosis and Associated Coinfections'; Bron https://www.mdpi.com/2076-2607/11/9/2301 ; Bron https://www.facebook.com/Lymefonds/
1 oktober 2023:..Helaas heeft dit weinig met wetenschap te maken. Geen study design, geen inclusie of exclusiecriteria, geen semi-objectieve manier om "beter" te definieren, geen poweranalyse, geen statistiek, geen medisch ethsche commissie, geen data safety monitoring board wat bij de combinatie van deze geneesmiddelen zeker geeist zou worden. De "special" waar dit verhaal onderdeel van is, bevat alleen dit artikel. Tot mijn verrassing wordt er geen "conflict of interest" gerapporteerd terwijl de auteurs de enigen zijn die patienten op deze manier behandelen en daar zeer goed voor betaald worden. Ik gun iedere Lymepatient een goede behandeling, maar deze cocktail van sterk werkende medicatie met serieuze bijwerkingen (van de cocktail zijn de bijwerkingen niet gerapporteerd) is zeer dubieus..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
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Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Di 23 Jul 2024, 16:45

Vervolg op; Bron viewtopic.php?f=5&t=2595&start=490#p30511
Bron https://nl-nl.facebook.com/drrichardhorowitz/ 20 juli 2024:..Ah, articles by Cureus. My favorite journal to comment on (and usually skewer). Please see the recent article on PTLDS, and read my comments that I posted below on the site. How and why the editors do not require a more comprehensive literature review, and why the authors selectively left out articles on dapsone combination therapy and disulfiram, is a mystery, although their discussing IDSA guidelines and leaving out ILADS guidelines point to certain blind spots...

I sometimes feel like I'm living in an alternative universe where the emperor has no clothes. Whether it is the Natl Academy of Sciences, a recent HHS meeting on Lyme and TBDs, authors publishing on chronic Lyme and PTLDS...it seems as if our work is falling on deaf ears. Maybe it won't with a RCT? We are in the process of having :arrow: Eva Garland consulting identify grants for a Lyme RCT. I am meeting with them again in one month to see what they have identified. In the meantime, reader beware. We have answers, and the incredible medical-political dysfunction ignoring essential research continues, although this article at least puts forward some of the research on persistence of Borrelia..
Is het gestelde in het comment van 20 juli 2024 juist?; Bron https://www.cureus.com/articles/260849- ... ab=true#!/
..During your scientific literature review, you have identified certain mechanisms responsible for symptoms in PTLDS, but you ignored essential scientific publications illustrating the importance of the biofilm/persister forms of Borrelia. These forms have been effectively treated in almost 400 patients over 9 years with dapsone combination therapy and show great promise as a short term oral antibiotic protocol for those suffering from chronic LD (yes, it is a chronic persistent infection) and PTLDS. The articles are listed below, along with Tulane research. The article published in Healthcare in 2018, also described up to 16 reasons why patients stay ill (6 overlapping causes of inflammation and 10 downstream effects, similarly seen in long COVID).
10 Dapsone Articles on The Effective Treatment of Chronic LD & Associated Co-infections Including Bartonella: As of May 11, 2024..

..You also ignored the important role of Babesia species, including emerging species like B. odocoilei, which have become resistant to standard therapies and other Bartonella species which are now frequently showing up in this chronically ill patient population. An article like this, which is an important topic, contains some of the scientific literature proving your hypothesis, but by your leaving out the above references, you have left out factors keeping Lyme patients ill: not only Borrelia, Babesia and Bartonella, but the role of environmental toxins like mold, leaky gut, microbiome abnormalities and mast cell activation, sleep disorders, mineral and vitamin deficiencies, hormone dysregulation, mitochondrial and liver dysfunction, neuropsychiatric dysfunction, and those who are deconditioned and require PT.

In the future, I suggest a more comprehensive literature review, not leaving out essential information that has already been published. Dapsone combination therapy and applying the 16 point MSIDS model has led to long term remission in many chronically ill patients. Leaving these out of your literature review is a big oversight. Please see the recent dapsone documentary that I filmed in 2024 on the success of this therapy, which will put faces and stories to the success of dapsone therapy and applying the 16 point MSIDS model.

Dapsone documentary: https://players.brightcove.net/63144520 ... 3288590112 ..
..'you have left out factors keeping Lyme patients ill: not only Borrelia, Babesia and Bartonella, but the role of environmental toxins like mold, leaky gut, microbiome abnormalities and mast cell activation, sleep disorders, mineral and vitamin deficiencies, hormone dysregulation, mitochondrial and liver dysfunction, neuropsychiatric dysfunction, and those who are deconditioned and require PT'..?

Is het gestelde juist? En is het 16 point MSIDS model; Bron https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6316761/ medisch én wetenschappelijk bewezen? Nee!
En kan het MSIDS model (waar ook sommige :arrow: *therapeuten; Bron https://lymeherstel.nl/besmetting-zelfs ... voor-lyme/ in Nederland mee werken!?..) worden gebruikt voor het diagnosticeren van (chronische) Lyme en coinfecties, Long Covid en allerlei andere ziekten? Nee! En is het model onafhankelijk gevalideerd? Nee!
Zijn de genoemde gepubliceerde artikelen verschenen in vooraanstaande en hoog aangeschreven medische én wetenschappelijke tijdschriften? Nee!

Tegenover de getuigenissen van de 18 patiënten genoemd in de dapsone presentatie; Bron https://players.brightcove.net/63144520 ... 3288590112 staan de vele getuigenissen van mensen-patiënten; Bron viewtopic.php?f=5&t=2595&start=400#p30156 die Dapson hebben gebruikt waarbij het niet goed is gegaan en sommigen in een noodsituatie of op de ER (spoedeisende hulp ziekenhuis) terecht zijn gekomen.

Disulfiram is niet dé oplossing gebleken; Bron viewtopic.php?f=5&t=2595&start=320#p29941

En zijn er intussen al Nederlandse patiënten blijvend verbeterd of genezen van (chronische) Lyme én Bartonella) met de kostbare en experimentele Disulfiram en DDDCT (double dose dapsone combination therapy) en HDDCT (short-term high dose pulsed dapsone combination therapy) en Quadruple Dapsone Treatment (4x Dapsone) behandelingen bij de artsen en de therapeuten in Nederland of in het buitenland?; Bron viewtopic.php?f=5&t=2595&start=270#p29801

Disulfiram (indicaties: als hulpmiddel bij de psychosociale begeleiding van alcoholisme, ter ondersteuning van het stoppen met drinken van alcohol) - Farmacotherapeutisch Kompas; Bron https://www.farmacotherapeutischkompas. ... disulfiram

:arrow: Brochure Lymevereniging - ICLB & Patiëntensymposium 2022; Bron https://lymevereniging.nl/wp-content/up ... 221115.pdf
..5. Brian Fallon (Columbia universiteit): Wanneer symptomen persisteren/ Symptomen na behandeling
..Maar: disulfiram-gerelateerde risico's kunnen ernstig zijn.
Fallon bespreekt veel voorkomende bijwerkingen: vergiftiging van de lever en ernstige bijwerkingen voor het perifere en centrale zenuwstelsel. Meestal zijn de bijwerkingen omkeerbaar na stoppen van de behandeling. Disulfiram kan ook nadelige interacties hebben met andere geneesmiddelen..

Het eerdere plan was om te starten met een Pilot study met 100 patiënten. Dat is (nog) niet gelukt? En daarna een Randomized Controlled Trial (RCT) te gaan opzetten?; Bron viewtopic.php?f=5&t=2595&start=390#p30144
..If I can get a :arrow: RCT done on dapsone combination therapy and the role of MSIDS factors in CLD/PTLDS :arrow: by the end of this year/or next, I will prove to the world what many of my patients know: that this short term oral generic protocol can lead to long lasting positive effects and help patients get back to work..

..With support from the **Lyme community, this could be a reality by :arrow: mid-2024. Now that we have new, more effective answers for Bartonella, it is time to launch **a 100 patient :arrow: pilot study..
Een **Pilot study is een kleinschalige voorstudie die wordt uitgevoerd om de haalbaarheid, duur, kosten, bijwerkingen te evalueren en het onderzoeksontwerp te verbeteren voorafgaand aan de uitvoering van een grootschalig onderzoeksproject.

Voor de **Randomized Controlled Trial (RCT) (is klinisch onderzoek en wetenschappelijk onderzoek een (cohort) study met verschillende patiëntengroepen én een controle groep) zijn de ambities erg hoog en de tijd zal leren of er een RCT opgezet kan worden en of de resultaten hetzelfde gaan bevestigen als allemaal is genoemd. Er is véél geld (5 miljoen dollar?!) voor nodig en de voorbereiding en het onderzoek zullen een aantal jaren gaan duren.

Zal het :arrow: Eva Garland consulting; Bron https://www.evagarland.com/ lukken om de benodigde gelden/subsidies voor een RCT te gaan krijgen?

LivLyme symposium; Bron https://www.facebook.com/drrichardhorowitz
..8 maart 2023: Lyme treatment protocols are not always covered by insurers. This is why a RCT of dapsone combination therapy is essential. Appx 50% go into long term remission after an 8 week oral, generic protocol if all MSIDS factors have been addressed. Once I have more information about the success of our recent Lyme-Bart protocols, I will design a study and get input from the major Lyme organizations. I mentioned in jest this weekend during the LivLyme conference, that the major Lyme organizations need to consider giving Johns Hopkins center 5 million dollars to do the dapsone study. Its really not a joke. They have the largest PTLDS patient group and a successful study there would help move the needle towards proving the success of recent biofilm/persister regimens..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 7911
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Wo 24 Jul 2024, 20:21

Vervolg
Bron https://nl-nl.facebook.com/drrichardhorowitz/ 24 juli 2024:..How will I know if I have Lyme disease?
The Medical Detective looks for clues as to the initial exposure and whether certain key symptoms are present during and post treatment. Read my latest Substack on how to use the Horowitz MSIDS Questionnaire (HMQ) to help diagnose Lyme disease..
Medical Detective Substack; Bron https://medicaldetective.substack.com/p ... irect=true
..6. Blood tests have confirmed a Lyme diagnosis.
More on testing in the next few Substacks..
..We will discuss in the next few Substacks the testing that is available to confirm a clinical diagnosis of chronic Lyme disease/PTLDS..

..Information about Validation for This Questionnaire
The original version of the Lyme/MSIDS Questionnaire was developed by Dr Joseph Burrascano years prior, after he took histories from his chronic Lyme patients. I then took the questionnaire and divided into 4 parts, asking questions about the frequency and severity of each symptom, while also capturing essential information on whether patients lived in Lyme endemic areas, had been bit by ticks, had EM rashes, asking whether their pain was migratory (a hallmark symptom of chronic Lyme disease), as well as reviewing the number of healthy mental and physical days they had in the past month.

The validation study for the Horowitz MSIDS Questionnaire (HMQ), proving that it is quite accurate, can be found below. It was done in 2017, and validated among 1,600 individuals in :arrow: three medical practices, who were both healthy and sick, i.e., suffering from chronic Lyme disease.
:arrow: Empirical Validation of the Horowitz Multiple Systemic Infectious Disease Syndrome Questionnaire for Suspected Lyme Disease. Maryalice Citera*, Ph.D., Phyllis R. Freeman2, Ph.D., Richard I. Horowitz2, M.D., International Journal of General Medicine 2017:10 249–273 http://www.ncbi.nlm.nih.gov/pubmed/28919803
https://www.dovepress.com/empirical-val ... ticle-IJGM

The results of a detailed statistical validation study by 2 Ph.D. psychologists at the State University of New Paltz showed that the Horowitz MSIDS Questionnaire (HMQ) showed convergent and divergent construct validity, as well as predictive validity. What does this mean? We can accurately classify the Lyme Status of an individual using the HMQ with an 87% accuracy. Compare that to standard two-tiered testing (STTT) using an ELISA and Western blot, which has an accuracy of about a coin flip i.e., 50%..
..'how to use the MSIDS Questionnaire (HMQ) to help diagnose Lyme disease..'?
..'information about Validation for This Questionnaire'..?
..'We can accurately classify the Lyme Status of an individual using the HMQ with an 87% accuracy'..?
..'Empirical Validation'..?

Is het gestelde juist? Empirisch onderzoek? De EliSpot-iSpot test en de Spirotest zijn na validatie onderzoek; Bron viewtopic.php?f=5&t=2595&start=430#p30228 onbetrouwbaar gebleken! De Nanotrap test is niet geschikt gebleken voor Europese Borrelia stammen!; Bron viewtopic.php?f=5&t=2322&start=450#p26499
.. :arrow: Methods
Study 1 examined the construct validity of the scale examining its factor structure and reliability of the questionnaire among 537 individuals being treated for Lyme disease. Study 2 involved an online sample of 999 participants, who self-identified as either healthy (N=217) or suffering from Lyme now (N=782) who completed the Horowitz MSIDS Questionnaire (HMQ) along with an outdoor activity survey. We examined convergent validity among components of the scale and evaluated discriminant validity with the Big Five personality characteristics. The third study compared a sample of 236 patients with confirmed Lyme disease with an online sample of 568 healthy individuals..

..Use a panel approach with indirect and direct tests to confirm a clinical diagnosis:
Indirect tests:
- ELISA
- C6 ELISA (preferred in European patients and US patients, as it includes B. afzelii, B. garinii, and B. burgdorferi).
- IFA
- IgM and IgG Western blots (pay attention to Borrelia specific bands: 23 [OspC], 31 [OspA], 34 [OspB], 39, 83/93). These can be present with different Borrelia species.
- ELISpot, Lymphocyte Transformation Test (LTT)
- Spirotest (CXCL9, CXCL10, CCL19)

Direct tests:
Nanotrap (urine Ag testing with OspA)
PCR
Culture

Other testing: other Borrelia species (including relapsing fever, B. miyamotoi) can cause Lyme-like syndromes. Check antibodies, PCR
Check coinfection testing if there is a malaria-like illness (Babesia spp.), atypical skin rashes resembling “stretch marks” (Bartonella spp.), and/or severe atypical clinical manifestations (rule out rickettsia, Q-fever, tularemia)..

..Acknowledgments
:arrow: We acknowledge and thank Sonja Siderias, LPN, Renee Nelson, Haley Moss Dillon, PhD, and our health care colleagues at Sojourns Community Health Clinic, Westminster, VT, USA, and Naturopathic Health Center, Southbury, CT, USA, for their assistance with our research. We would also like to thank Christina Covington for her help conducting a pre-test study and the SUNY New Paltz Summer Undergraduate Research Experience (SURE) for providing funding for that summer program. The authors thank Basant Puri and Sunny Duerr for their valuable statistics suggestions and the three anonymous reviewers of this article for their very helpful comments and recommendations..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 7911
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Vr 26 Jul 2024, 17:58

Vervolg op; Bron viewtopic.php?f=5&t=2595&start=460#p30427 en vervolg op; Bron viewtopic.php?f=5&t=2683&start=30#p30391
..rtl nieuws
28 mei 2024
Tekentijd - Wim kwam thuis met 23 teken, en doet mee aan proef met vaccin tegen ziekte van Lyme; Bron https://www.rtl.nl/nieuws/artikel/54519 ... t-23-teken ..

National Geographic - Wetenschap
26 juli 2024
Kunnen we ons straks laten vaccineren tegen de ziekte van Lyme?; Bron https://www.nationalgeographic.nl/weten ... accin-lyme
..Jaarlijks houden zo’n 1500 Nederlanders per jaar ernstige klachten over aan een tekenbeet. Hoe mooi zou het zijn als dat in de toekomst kan worden voorkomen met een vaccin?

Het RIVM en het Amsterdam UMC Multidisciplinair Lymeziekte centrum (AMLC) waarschuwen al jaren voor de gevaren van tekenbeten. De beestjes kunnen een bacterie bij zich dragen die Lymeziekte kan veroorzaken, een vervelende infectieziekte. Maar ondanks alle inspanningen lopen jaarlijks toch 25.000 tot 30.000 Nederlanders de ziekte van Lyme op.

Van deze mensen merkt 1500 de tekenbeet te laat of helemaal niet op. Zij kunnen daar ernstige klachten aan overhouden, waaronder hersenzenuwuitval. Bij sommigen zijn de klachten langdurig, zelfs na een behandeling met antibiotica. Er zijn behoorlijk wat tips om de ziekte van Lyme te voorkomen, maar een vaccin zou natuurlijk nóg effectiever zijn. Goed nieuws: dat is in de maak.

De stand van zaken
‘Er loopt momenteel een zogeheten fase III-studie naar een vaccin tegen Lymeziekte, waar onder meer het Amsterdam UMC aan meewerkt,’ vertelt Joppe Hovius. Hij is hoogleraar, arts en oprichter van het AMLC. Voordat een vaccin de markt op mag, worden verschillende fases doorlopen. Per fase wordt het vaccin bij een steeds grotere groep mensen getest op potentiële bijwerkingen. In fase III krijgen duizenden mensen het vaccin toegediend.

Bijwerkingen
Het vaccin dat nu in de maak is, is niet de eerste poging om Lymeziekte te bestrijden. Eind jaren negentig van de vorige eeuw was er kort een vaccin tegen Lyme beschikbaar in de Verenigde Staten. Maar dat werd wegens (vermeende) bijwerkingen in 2002 van de markt gehaald. ‘Het stukje eiwit dat destijds als boosdoener werd aangewezen, is uit dit vaccin gehaald om eventuele discussies te voorkomen,’ aldus arts Joppe Hovius.

‘Dat het vaccin de eerste twee fases heeft doorstaan, is een goed teken,’ vertelt Hovius. ‘Maar de echte resultaten komen aan het einde van de derde fase.’ Die loopt tot 2025. De verwachting is dat in 2026 bekend is of het vaccin inderdaad veilig en effectief is.

Zo werkt het vaccin tegen Lymeziekte
Een teek maakt ons ziek door de bacterie Borrelia burgdorferi in ons lichaam te brengen. Dat gebeurt nadat hij zich heeft vastgebeten in onze huid en zich tegoed doet aan een bloedmaaltijd. Hoe kan dit vaccin voorkomen dat dat gebeurt?

Het is een zogeheten transmissieblokkerend vaccin,’ legt Hovius uit. ‘Je wordt gevaccineerd met een eiwit van de bacterie die Lymeziekte veroorzaakt. Je lichaam maakt daarop antistoffen aan. Als je wordt gebeten door een besmette teek, neemt de teek het bloed op met daarin de antistoffen. De bacterie wordt in de teek door de antistoffen herkend en gedood, nog voordat hij in het lichaam van de mens terechtkomt.’

Verschillende tekenziekten
In het Amsterdam UMC loopt momenteel nog een ander onderzoek naar een tekenvaccin. Maar dat bevindt zich nog in de zogenaamde preklinische fase. Oftewel: het absolute begin. Dat vaccin moet voorkomen dat de teek zich überhaupt kan voeden en zo bacteriën en virussen kan overdragen.

Vrijwillige tekenbeten
Een onderzoek naar een dergelijk vaccin heet TICK ME. Proefpersonen laten zich vrijwillig door tien teken bijten. Deze zijn speciaal gekweekt in het laboratorium en vrij van bekende humane ziekteverwekkers. Het doel is achterhalen welke antistoffen deze vrijwilligers aanmaken tegen de eiwitten in het tekenspeeksel. Die informatie kun je gebruiken om een vaccin tegen de teek te ontwikkelen. Dat zou moeten voorkomen dat de teek zich überhaupt kan voeden met jouw bloed.

Dit vaccin zou meerdere vliegen in één klap slaan. Teken veroorzaken namelijk niet alleen Lymeziekte, maar ook andere ziekten, zoals tekenencefalitis. In 2016 is vastgesteld dat sommige Nederlandse teken dit virus bij zich dragen. Raak je besmet, dan veroorzaakt het virus een hersen(vlies)ontsteking. Sinds 2016 kregen zo’n 25 patiënten deze diagnose.

‘Ik wil zeker niet de alarmbel luiden, want de ziekte is tot op heden zeer zeldzaam,’ verzekert Hovius. ‘Maar als je deze andere tekenbeetziekten niet onderzoekt, dan kun je ze ook niet vinden.’..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 7911
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Ma 29 Jul 2024, 15:42

Vervolg op; Bron viewtopic.php?f=5&t=2595&start=480#p30505
..2 juli 2024: The Academy of Nutritional Medicine (AONM) (Engeland)/ArminLabs(Duitsland) - TITLE: Advancements in CD Cell, Lyme, and Coinfection Research: Insights from Recent Studies - Round Table Discussion - Speakers: Professor Leona Gilbert, Professor Jack Lambert, Dr. Minha Rajput-Ray, Gordana Avramovic, and Mr. Kunal Garg; Bron https://aonm.org/view-past-webinars/ en Bron https://www.youtube.com/watch?v=lx326Rg3mu4
..Note: Presentation slides are unavailable for the time being due to research papers being submitted for publication..
..Irish Study Overview
..Xi et al. 2023: Clinical symptomes and treatment outcomes..
..Xi et al. 2024: Immune markers and biomarkers..
..Garg et al. 2024: Pain and biomarker correlations..
..**Blehle et al. 2024: Prevalence and economic impact..
..'You will learn about the innovative EliSpot assay, unveiling T cell responses to Borrelia burgdorferi infection and gain an understanding of how this T cell-based approach bridges diagnostic gaps, especially for seronegative patients'..?
..'The authors will offer insights into the dissociation between humoral and cellular immune responses, and the great potential of EliSpot in identifying Borrelia infections'..?

..'as they discuss their groundbreaking studies on CD cells, Lyme disease, and Coinfections'..?
..'The discussion will include observations of their publications based on patient data, highlighting the collaborative effort to bring real-world patient data into published articles'..?
..

MDPI
Publicatie 25 juli 2024
Open Access Article: 'Biomarker-Based Analysis of Pain in Patients with Tick-Borne Infections before and after Antibiotic Treatment' by Kunal Garg, Abbie Thoma, Gordana Avramovic, Leona Gilbert, Marc Shawky, Minha Rajput Ray and John Shearer Lambert; Bron https://www.mdpi.com/2079-6382/13/8/693
..3.5. Study Limitations and Future Research Directions
This study has several limitations that should be considered. Firstly, while substantial, the cohort size of 186 patients may differ from the broader population with similar conditions, potentially limiting the generalizability of our findings. Secondly, the reliance on self-reported pain ratings introduces a subjective element that could affect the accuracy of the results. We only measured a specific set of biomarkers, which might not encompass all relevant biological factors influencing pain perception and treatment response.

The retrospective and longitudinal nature of the study, while valuable for observing changes over time, does not include a control group, which limits the ability to draw definitive causal conclusions about the treatment’s effectiveness. Expanding the range of biomarkers studied will provide a more comprehensive understanding of the factors influencing pain and treatment outcomes. Investigating the role of other potentially confounding variables, such as psychological factors and the duration of infection, could also yield valuable insights into the complexities of pain management in patients with tick-borne infections who experience ongoing symptoms. Lastly, although participants received various antibiotic regimens with different durations [13], the study focused on the overall trend in pain reduction across the cohort. The significant reduction in pain scores observed in Figure 2 due to the overall treatment regimens suggests a generalizable effect of antibiotic therapy. While the natural course of the disease may lead to spontaneous pain resolution, the statistical significance and consistency of the pain reduction point towards a treatment effect (Figure 2 and Figure 3). While a placebo-controlled group would provide stronger causal evidence, the open-label design still offers valuable insights, supported by our prior studies demonstrating the efficacy of antibiotic treatments in reducing TBI symptoms [13,41]..
..4.2. Patient Cohort and Sample Size Estimation
This study invited individuals over 16 who obtained consultations at the outpatient infectious diseases clinic at The Mater Misericordiae University Hospital in Ireland. The purpose of the study was to include patients suspected of having tick-borne infections. After being evaluated by the doctor during the initial visit (T0), :arrow: a total of 301 patients were examined, and 210 were diagnosed with tick-borne infections (TBIs) and prescribed antibiotics from T0 (baseline before treatment) to T2 (after antibiotic treatment). These individuals exhibited symptoms resembling Lyme disease, such as a general flu-like sickness and a medical suspicion of infections transmitted by ticks. This suspicion was based on factors such as one or several tick bites, previous occurrence of a distinctive rash resembling a bull’s eye, or prior exposure to locations where ticks are prevalent. Participants completed a survey [13,19] that assessed their pain levels on a scale of 1 to 10 (with 10 indicating severe pain) before and after treatment, time points T0 and T2. This study analyzed a total of 186 participants in its final cohort. The study employed a longitudinal methodology, which involved studying changes over time within a consistent group of participants. This strategy differs from retrospective case-control studies, which compare people with a given outcome (cases) to individuals without the outcome (controls) [66,67]..
..4.3. Analyses of Immune Markers and Biomarkers
Immune indicators and biomarkers were analyzed by collecting blood samples and examining them for abnormalities before (T0) and after treatment (T2). The immunological markers analyzed in this group were CD3+, CD8+, CD4+, CD57+, CD19+, cell percentages, and cell counts. In addition, we conducted tests to determine the H/S ratio, neutrophil count, total lymphocyte count, total white cell count (WCC), and the levels of total IgG, IgA, and IgM. We examined the lymphocyte percentage and total cell count for each category of lymphocytes. Furthermore, we performed laboratory tests on commonly used clinical biomarkers, including hemoglobin (Hg), platelets, rheumatoid factor (RF), anti-nuclear antibodies (ANA), C-reactive protein (CRP), iron, transferrin, transferrin saturation percentage, ferritin, folate, creatine kinase (CK), free thyroxine (FT4), and thyroid stimulating hormone (TSH). Abnormal values for each marker were determined as patient laboratory values that deviated either above or below the reference levels [51]. All laboratory tests were conducted at The Mater Misericordiae University Hospital, ensuring consistency in testing methodology and minimizing variations in results..

:arrow: Vergelijk met..
MDPI
Publicatie 24 augustus 2023
Open Access Article - 'A Longitudinal Study of a Large Clinical Cohort of Patients with Lyme Disease and Tick-Borne Co-Infections Treated with Combination Antibiotics' by David Xi, Abbie Thoma, Minha Rajput-Ray, Anne Madigan, Gordana Avramovic, Kunal Garg, Leona Gilbert, John S. Lambert; Bron https://doi.org/10.3390/microorganisms11092152

De :arrow: 301 patiënten zijn getest met de kostbare en niet-gevalideerde TickPlex Basic test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only; en de kostbare en niet-gevalideerde TickPlex Plus test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only van Tezted (Finland)? Met de testen kunnen géén diagnoses Lyme/chronische Lyme/neuroborreliose/Post-lymeziektesyndroomworden en of coinfecties worden gesteld en kunnen géén behandelingen worden gemonitord!!


..'The immunological markers analyzed in this group were CD3+, CD8+, CD4+, CD57+, CD19+, cell percentages, and cell counts'..?

Is het gestelde juist dat er immune markers en biomarkers en pain and biomarker correlations medisch én wetenschappelijk zijn vastgesteld en bewezen?
De patiënten zijn getest met de testen van ArminLabs (Duitsland)??; Bron https://www.arminlabs.com/nl/tests/cd19-lymphozyten en Bron https://www.arminlabs.com/nl/tests/nk-cells-cd

De CD3/CD57 test mag géén 'Lyme test' worden genoemd en is géén test om chronische Lyme mee vast te kunnen stellen!

Informatie Stichting Tekenbeetziekten - Het meten van het aantal CD57 lymfocyten; Bron https://www.tekenbeetziekten.nl/de-teek ... /diagnose/
..Het meten van het aantal CD57 lymfocyten
Deze test meet via antigenen het aantal CD57 lymfocyten, een bepaald soort bloedcellen die helpen om infecties op te ruimen. Met name chronische Lymepatiënten zouden een laag aantal CD57 cellen hebben en bij antibiotica behandeling en herstel van de ziekte zou dit aantal weer omhooggaan, tenminste volgens sommige ILADS-artsen. Ook bij diverse heel andere ziektes kan het aantal CD57 cellen echter verlaagd zijn en er zijn ook chronische Lyme patiënten die wél een normale of zelfs hoge CD57 score hebben. Het is dus niet terecht om de CD57 test een ‘Lyme test’ te noemen. De test heeft beperkte waarde voor Lyme diagnostiek en wordt in Nederland weinig gebruikt..

:arrow: En verglijk met..
Lyme Resource Centre (LRC) Dublin: Publicatie Posters & Powerpoint Slides - 3rd European Crypto-Infections Conference 2023; Bron https://www.lymeresourcecentre.com/3rd- ... rence-2023

Slides: 'Incidence of various tick-born infections (TBIs) and co-infections in a cohort of patients presenting to an infectious disease clinic with Lyme-like symtoms' by Thoma A¹, Avramovic G², Rajput-Ray M³, Gilbert L⁴, Madigan A², Lambert J¹,²; Bron https://www.lymeresourcecentre.com/_fil ... f517b4.pdf

Slides: 'A Decrease In CD57+ NK Cells Is Demonstrated In Patients Positive For Tick-Borne Infections' by Thoma A¹, Avramovic G², Rajput-Ray M³ Gilbert L⁴, Madigan A², Lambert J¹,²; Bron https://www.lymeresourcecentre.com/_fil ... 50a769.pdf

Slides: 'A Greater Severity Of Fatigue Is Demonstrated In Weakly Antibody-Positive Patients In A Tick-Borne Infection (TBI) Cohort' by Thoma A¹, Avramovic G², Rajput-Ray M³, Gilbert L⁴, Madigan A², Lambert J¹,²; Bron https://www.lymeresourcecentre.com/_fil ... 2d0421.pdf
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 7911
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Ma 29 Jul 2024, 16:15

Vervolg

En de opmerkingen van 'Reviewer 1: Robert Bransfield, Reviewer 2: Dale Quest, Reviewer 3: Anonymous'; Bron https://www.mdpi.com/2079-6382/13/8/693/review_report
..Round 1
Reviewer 3 Report
Comments and Suggestions for Authors

General Comments
This cohort study examined the relationship between pain and biomarkers in tick-borne illnesses (TBI) patients from an Irish hospital and their response to antibiotic treatment. One major concern of this study is that the diagnosis of TBI seems to be simply based on clinical decision rather than laboratory findings. It is unclear whether each of these patients met the criteria of high-risk tick-bite infection [i.e. (a) an identified vector species, (b) it occurred in a highly endemic area, and (c) the tick was attached for ≥36 hours, as per the IDSA guidelines] There could be other differentials that could explain the patients’ presentations.

Moreover, there is a lack of details on the laboratory testing (e.g. testing method, location of laboratory). This is important as the focus of this manuscript is on immune indicators and biomarkers. If these markers were measured using different methodologies, this can contribute to variation in results. The numerical value differences in the biomarkers are clinically trivial despite showing statistical significance. It is unclear why the Mann-Whitney U and Kolmogorov-Smirnov tests were used instead of some fundamental statistical analysis like paired t-test and Wilcoxon signed ranks test.

Another concern is the conclusion being made. Although it is true there is no good biomarkers for pain, this does not emphasize the need for appropriate antibiotic treatment for TBIs. These seem to be two separate issues here. As the IDSA 2020 guidelines on Lyme Disease have stated (section XXIV and XXV) https://doi.org/10.1093/cid/ciaa1215: “For patients who have persistent or recurring nonspecific symptoms such as fatigue, pain, or cognitive impairment following recommended treatment for Lyme disease, but who lack objective evidence of reinfection or treatment failure, it is recommended against additional antibiotic therapy.”

Although opinions differ on the management of chronic Lyme disease, it is important to address opposing views so the conclusion can be evidence-based and non-biased.


Abstract:
Line 27-28: Median pain scores dropping does not suggest a persistent infection responsive to antibiotics. Reduction in pain can simply be a natural course of a disease when an illness self-resolves.

Line 34-35: Although it is true there is no good biomarkers for pain, this does not emphasize the need for appropriate antibiotic treatment for TBIs. These seem to be two separate issues here.


Specific Comments
Introduction:
Line 55: Reference 9 is on the 2006 IDSA guidelines on Lyme Disease. There is now a 2020 edition of the IDSA guidelines on Lyme Disease. https://doi.org/10.1093/cid/ciaa1215

Line 56-58: Can you provide the references for the first two sentences of this paragraph. This is important as you are trying to give us the case definition of PTLDS – is this an official definition (if yes, which organization?)

Line 64-66: It is unclear to readers why you are talking about pain difference due to age and gender here. Your references 20-24 are not specific to PTLDS. If that is meant to explain the gender and age difference in your study, then this paragraph should be included in the discussion, not the introduction.


Results:
Line 123-124: Is it possible that these participants received various regimen of antibiotics with different duration? Then T0 to T2 are very much heterogeneous, with multiple events that can happen in between. For pain-control in an open-labelled trial, it is expected that patients would perceive some improvement. Sometimes, the pain would self-resolve due to the natural course of the disease. Without a placebo-controlled group, it is hard to say whether the reduction in pain is due to antibiotics or not.

Line 129-130: Like the comments I made in the previous paragraph, there are many confounders that can lead to change in these biomarkers. The changes as shown in Table 1 look clinically trivial even though you showed statistical significance. However, I wonder whether it makes more sense to use paired t-test or Wilcoxon signed rank test when comparing two paired numerical values. I wonder whether the Mann-Whitney U and Kolmogorov-Smirnov were used because they gave more favorable statistical results. Some justifications are needed on why these two statistical tests are favored over some fundamental statistical tests.

Line 181: I cannot see the symbol between p-value and 0.05. Is it ≥ or ≤?


Discussion:
Line 271: Like my comment in Line 123-124, the pain improvement can be multi-factorial. This does not indicate clear improvement in pain scores following treatment.

Line 274: Like my comments in Line 129-130, the differences in the biomarkers are clinically trivial. They may not demonstrate significant differences.

Line 280-281: If you are saying these biomarkers are unreliable indicators of pain levels or the efficacy of pain management, then why are you choosing these as your biomarkers in the study?

Line 332-356: There are quite a lot of discussion on other pathogens, medical conditions and biomarkers not measured in the current study (e.g. UTI, TLR4, persistent low back pain, irritable bowel syndrome). I am not sure whether they are necessary. They seem to distract the readers from learning the main message of your study.

Line 392: Like my comments in Line 123 and 271, the current study did not seem to show strong evidence that antibiotic decreases pain.

Line 385-403: Although I appreciate the empathy towards patients, the current study did not demonstrate benefit of antibiotics and prolonged duration of antibiotics. A comparison trial would be needed to support the claim.


Conclusions:
Median pain scores dropping does not suggest a persistent infection responsive to antibiotics. Reduction in pain can simply be a natural course of a disease when an illness self-resolves. A big confounder could be placebo-effect in an open-labelled cohort study.

Although it is true there is no good biomarker for pain, this does not emphasize the need for appropriate antibiotic treatment for TBIs. These seem to be two separate issues here.

Methods:
Line 432-438: It seems like the diagnosis of TBI is simply based on clinical suspicion. This may be prone to errors as there could be recall bias of tick bites and rash. There could be other differentials that could explain the patients’ presentations. As your reference of IDSA Lyme Disease Guidelines have stated, clinical diagnosis is made on potential tick exposure in a “Lyme disease endemic area” who have 1 or more skin lesions compatible with erythema migrans. But this study never stated whether these patients had tick bite in endemic areas. The identity of the ticks are unknown (some may be not be known to be pathogenic). Besides, these patients might not have experience a high-risk tick-bite infection [i.e. (a) an identified Ixodes spp. vector species, (b) it occurred in a highly endemic area, and (c) the tick was attached for ≥36 hours] as per IDSA. Therefore, antibody testing should be sought for a confirmatory diagnosis i.e. antibody testing performed on an acute-phase serum sample (followed by a convalescent-phase serum sample at least 2–3 weeks after collection of the acute-phase serum sample), as per IDSA.

Line 446-458: It seems unclear whether these patients had their laboratory testing performed in the same laboratory. Different laboratories use different methods to analyze immune indicators and biomarkers, potentially leading to different normal value range.

Line 500: To ensure the methodologies are repeatable, the statistic softwares used need to be specified. Microsoft Excel would not be able to perform advanced functions like the Mann–Whitney U test.

Was there a sample size calculation to ensure a sufficient sample size was achieved?

Were the subjects blinded from knowing what treatment they received? This could play a role on whether patients perceive pain improvement from the treatment.


References:
Line 562-702: If the publication month of the journal articles do not need to be included as per the MDPI journal format, please remove it.

Line 583: Reference 9 is on the 2006 IDSA guidelines on Lyme Disease. There is now a 2020 edition of the IDSA guidelines on Lyme Disease. https://doi.org/10.1093/cid/ciaa1215

Line 689-694: It looks like you have different fonts for references 55 and 56. Please consider changing the font to make it uniform in the entire manuscript..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 7911
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Ma 29 Jul 2024, 17:43

Vervolg

En de reacties van de auteur(s); Bron https://www.mdpi.com/2079-6382/13/8/693/review_report
..Author Response

Comment 1: One major concern of this study is that the diagnosis of TBI seems to be simply based on clinical decision rather than laboratory findings. It is unclear whether each of these patients met the criteria of high-risk tick-bite infection [i.e. (a) an identified vector species, (b) it occurred in a highly endemic area, and (c) the tick was attached for ≥36 hours, as per the IDSA guidelines] There could be other differentials that could explain the patients’ presentations.

Response 1: Firstly, it is important to note that an expert with extensive experience in tick-borne illnesses conducted the clinical assessments. In lines 470 to 474 of material and methods, section 4.2 patient cohort clarifies that “individuals exhibited symptoms resembling Lyme disease, such as a general flu-like sickness and a medical suspicion of infections transmitted by ticks. This suspicion was based on factors such as one or several tick bites, previous occurrence of a distinctive rash resembling a bull's eye or prior exposure to locations where ticks are prevalent.” Secondly, while we acknowledge the IDSA guidelines, it is important to understand that they primarily address acute infection. The criteria mentioned, such as the tick being attached for ≥36 hours, are not necessarily evidence-based for all stages of TBI. Our approach aligns with the clinical realities observed by experts in the field, as supported by previously published literature (reference 19). Lastly, our study focused on the pain and biomarkers in patients diagnosed with TBIs, emphasizing those with persistent symptoms responsive to antibiotic treatment. For more detailed information on the effectiveness of antibiotic treatments, we refer you to our previously published article on this topic (references 13 and 41). We believe this clarifies the basis of our clinical diagnoses and the rationale behind our methodology.


Comment 2: Moreover, there is a lack of details on the laboratory testing (e.g. testing method, location of laboratory). This is important as the focus of this manuscript is on immune indicators and biomarkers. If these markers were measured using different methodologies, this can contribute to variation in results.

Response 2: All blood tests were conducted by the same hospital laboratory at The Mater Misericordiae University Hospital, ensuring consistency in testing methodologies and minimizing any potential variations in results (lines 515 to 516). This addition addresses the concern about methodological variations.


Comment 3: The numerical value differences in the biomarkers are clinically trivial despite showing statistical significance. It is unclear why the Mann-Whitney U and Kolmogorov-Smirnov tests were used instead of some fundamental statistical analysis like paired t-test and Wilcoxon signed ranks test.

Response 3: Our explanation in lines 535 to 538 underscores the appropriateness of our chosen statistical methods and addresses the concerns regarding the suitability of alternative tests. The Mann-Whitney U and Kolmogorov-Smirnov tests were selected due to the specific characteristics of our data. These non-parametric tests are particularly suitable for our analysis for several reasons:
1. Data Distribution: Our data did not meet the normality assumptions (Figure S1) required for parametric tests like the paired t-test. The Mann-Whitney U and Kolmogorov-Smirnov tests do not assume a normal distribution, making them more appropriate for our dataset.
2. Comparing Distributions: Our analysis focused on the central tendency and the overall distribution of the biomarkers. The Kolmogorov-Smirnov test compares the distributions of two samples, providing a more comprehensive understanding of the data.
3. Robustness to Outliers: Non-parametric tests like the Mann-Whitney U test are less affected by outliers and skewed data, ensuring a more reliable analysis under these conditions.

While paired t-tests and Wilcoxon signed ranks tests are valid for certain analyses, they were less suitable for our data characteristics and the specific focus on distributional differences.


Comment 4: Another concern is the conclusion being made. Although it is true there is no good biomarkers for pain, this does not emphasize the need for appropriate antibiotic treatment for TBIs. These seem to be two separate issues here. As the IDSA 2020 guidelines on Lyme Disease have stated (section XXIV and XXV) https://doi.org/10.1093/cid/ciaa1215: “For patients who have persistent or recurring nonspecific symptoms such as fatigue, pain, or cognitive impairment following recommended treatment for Lyme disease, but who lack objective evidence of reinfection or treatment failure, it is recommended against additional antibiotic therapy.”

Response 4: We respectfully disagree with the assertion that the conclusion regarding the need for appropriate antibiotic treatment for TBIs is separate from the discussion on biomarkers and pain. Our study provides evidence that persistent symptoms in TBI patients, including pain, significantly decrease following antibiotic treatment, suggesting that these symptoms may be due to a persistent infection responsive to antibiotics (see Figures 3, 4, and S4). This aligns with findings from previous studies on the same patient cohort: Xi et al., 2023 (reference 13) indicated that prolonged use of combination antibiotics resulted in significant improvements in patient-reported symptoms, including pain, fatigue, and neurological symptoms. Also, Xi et al., 2024 (reference 41) demonstrated that combination antibiotics effectively relieve TBI symptoms with good patient tolerance. These results underscore the connection between the reduction in pain symptoms and antibiotic treatment, supporting the conclusion that appropriate antibiotic therapy is crucial for managing persistent symptoms in TBI patients. While the IDSA 2020 guidelines recommend against additional antibiotic therapy in certain cases, our study provides evidence of symptom improvement with such treatment, warranting further investigation and consideration in clinical practice.


Comment 5: Although opinions differ on the management of chronic Lyme disease, it is important to address opposing views so the conclusion can be evidence-based and non-biased.

Response 5: We appreciate the importance of presenting a balanced and evidence-based conclusion, especially given the differing opinions on managing chronic Lyme disease. We have revised the conclusion to acknowledge the differing views and highlight the need for further investigation (lines 588 to 594).


Comment 6: Line 27-28: Median pain scores dropping does not suggest a persistent infection responsive to antibiotics. Reduction in pain can simply be a natural course of a disease when an illness self-resolves.

Response 6: We respectfully disagree with the assertion that the reduction in median pain scores does not indicate a persistent infection responsive to antibiotics. While pain reduction may occur naturally over the course of a disease, our study’s findings demonstrate that the significant decrease in pain scores following antibiotic treatment cannot be attributed solely to the natural resolution of the disease (see Figures 3, 4, S4, and Table 2). Our manuscript highlights that this decrease is statistically significant (see Table S1) and consistent with previous research (see our response to comment 4) on the effectiveness of antibiotic therapy in managing symptoms of chronic Lyme disease and other TBIs.


Comment 7: Line 34-35: Although it is true there is no good biomarkers for pain, this does not emphasize the need for appropriate antibiotic treatment for TBIs. These seem to be two separate issues here.

Response 7: Please refer to our responses 4 and 6.


Comment 8: Line 55: Reference 9 is on the 2006 IDSA guidelines on Lyme Disease. There is now a 2020 edition of the IDSA guidelines on Lyme Disease. https://doi.org/10.1093/cid/ciaa1215

Response 8: We have updated the recommended reference (see reference 5).


Comment 9: Line 56-58: Can you provide the references for the first two sentences of this paragraph. This is important as you are trying to give us the case definition of PTLDS – is this an official definition (if yes, which organization?)

Response 9: We added references supporting the inquired sentences in lines 71 to 73.


Comment 10: Line 64-66: It is unclear to readers why you are talking about pain difference due to age and gender here. Your references 20-24 are not specific to PTLDS. If that is meant to explain the gender and age difference in your study, then this paragraph should be included in the discussion, not the introduction.

Response 10: We have separately discussed the topic of age and gender in studying pain in section 3.2 of the discussion. The purpose of introducing pain in lines 74 to 91 is to help readers understand that, while pain is a common symptom in PTLDS patients, age and gender can significantly influence the severity and prevalence of pain, as indicated by research in other fields. Consequently, before delving into our study's pain or biomarker patterns, we analyzed how age and gender affected pain ratings in our study population, as this would inform the statistical methodology. Therefore, in the context of our paper, we believe it is appropriate to introduce the influence of age and gender on pain at the beginning. This ensures that when Figure 1 demonstrates age and gender do not affect pain ratings in the present study population, readers can follow the rest of the findings without concerns about confounding variables such as age and gender..
..'Response 1: Firstly, it is important to note that an expert with extensive experience in tick-borne illnesses conducted the clinical assessments'..?
..'Response 2: All blood tests were conducted by the same hospital laboratory at The Mater Misericordiae University Hospital, ensuring consistency in testing methodologies and minimizing any potential variations in results (lines 515 to 516). This addition addresses the concern about methodological variations'..?

De bezorgdheid wordt niet weggenomen want de zogenoemde expert heeft de :arrow: 301 patiënten getest met de kostbare en niet-gevalideerde TickPlex Basic test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only; en de kostbare en niet-gevalideerde TickPlex Plus test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only van Tezted (Finland)? Met de testen kunnen géén diagnoses Lyme/chronische Lyme/neuroborreliose/Post-lymeziektesyndroomworden en of coinfecties worden gesteld en kunnen géén behandelingen worden gemonitord!!

En zie de Slides: 'Incidence of various tick-born infections (TBIs) and co-infections in a cohort of patients presenting to an infectious disease clinic with Lyme-like symtoms' by Thoma A¹, Avramovic G², Rajput-Ray M³, Gilbert L⁴, Madigan A², Lambert J¹,²; Bron https://www.lymeresourcecentre.com/_fil ... f517b4.pdf

Slides: 'A Decrease In CD57+ NK Cells Is Demonstrated In Patients Positive For Tick-Borne Infections' by Thoma A¹, Avramovic G², Rajput-Ray M³ Gilbert L⁴, Madigan A², Lambert J¹,²; Bron https://www.lymeresourcecentre.com/_fil ... 50a769.pdf

Slides: 'A Greater Severity Of Fatigue Is Demonstrated In Weakly Antibody-Positive Patients In A Tick-Borne Infection (TBI) Cohort' by Thoma A¹, Avramovic G², Rajput-Ray M³, Gilbert L⁴, Madigan A², Lambert J¹,²; Bron https://www.lymeresourcecentre.com/_fil ... 2d0421.pdf


..'The immunological markers analyzed in this group were CD3+, CD8+, CD4+, CD57+, CD19+, cell percentages, and cell counts'..?

Is het gestelde juist dat er immune markers en biomarkers en pain and biomarker correlations medisch én wetenschappelijk zijn vastgesteld en bewezen?
En de zogenoemde expert heeft de patiënten getest met de testen van ArminLabs (Duitsland)??; Bron https://www.arminlabs.com/nl/tests/cd19-lymphozyten en Bron https://www.arminlabs.com/nl/tests/nk-cells-cd

De CD3/CD57 test mag géén 'Lyme test' worden genoemd en is géén test om chronische Lyme mee vast te kunnen stellen!

Informatie Stichting Tekenbeetziekten - Het meten van het aantal CD57 lymfocyten; Bron https://www.tekenbeetziekten.nl/de-teek ... /diagnose/
..Het meten van het aantal CD57 lymfocyten
Deze test meet via antigenen het aantal CD57 lymfocyten, een bepaald soort bloedcellen die helpen om infecties op te ruimen. Met name chronische Lymepatiënten zouden een laag aantal CD57 cellen hebben en bij antibiotica behandeling en herstel van de ziekte zou dit aantal weer omhooggaan, tenminste volgens sommige ILADS-artsen. Ook bij diverse heel andere ziektes kan het aantal CD57 cellen echter verlaagd zijn en er zijn ook chronische Lyme patiënten die wél een normale of zelfs hoge CD57 score hebben. Het is dus niet terecht om de CD57 test een ‘Lyme test’ te noemen. De test heeft beperkte waarde voor Lyme diagnostiek en wordt in Nederland weinig gebruikt..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 7911
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Di 30 Jul 2024, 16:59

Vervolg

En de reacties van de auteur(s); Bron https://www.mdpi.com/2079-6382/13/8/693/review_report
..Comment 11: Line 123-124: Is it possible that these participants received various regimen of antibiotics with different duration? Then T0 to T2 are very much heterogeneous, with multiple events that can happen in between. For pain-control in an open-labelled trial, it is expected that patients would perceive some improvement. Sometimes, the pain would self-resolve due to the natural course of the disease. Without a placebo-controlled group, it is hard to say whether the reduction in pain is due to antibiotics or not.

Response 11: The participants in our study received various antibiotic regimens, :arrow: as noted in Xi et al., 2023. Moreover, we would like to address several points in your comment:
1. Heterogeneity and Standardization: Different regimens and durations may introduce heterogeneity, but our study design accounted for this by focusing on the overall trend in pain reduction across the entire cohort. The significant reduction in median pain scores from 7 to 5 (U = 27215.50, p < 0.001) observed consistently across different treatment regimens suggests a generalizable effect of antibiotic therapy on pain reduction.
2. Natural Course of Disease: Although the natural course of the disease may lead to spontaneous pain resolution in some cases, the statistical significance and consistency of the pain reduction observed in our cohort point towards a treatment effect. This is further supported by similar findings in prior studies on the same patient cohort, which have demonstrated the efficacy of antibiotic treatments in reducing symptoms of TBIs ( :arrow: references 13 and 41).
3. Placebo-Controlled Group: While a placebo-controlled group would strengthen the causal inference, the open-label design of our study still provides valuable insights. The observed improvements align with the clinical experience and prior research, indicating that the reduction in pain is likely due to the antibiotic treatment rather than a placebo effect or natural disease progression.

To clarify the above-mentioned points further, we have revised the manuscript to include a discussion of these points in section 3.5, lines 447 to 455.


Comment 12: Line 129-130: Like the comments I made in the previous paragraph, there are many confounders that can lead to change in these biomarkers. The changes as shown in Table 1 look clinically trivial even though you showed statistical significance. However, I wonder whether it makes more sense to use paired t-test or Wilcoxon signed rank test when comparing two paired numerical values. I wonder whether the Mann-Whitney U and Kolmogorov-Smirnov were used because they gave more favorable statistical results. Some justifications are needed on why these two statistical tests are favored over some fundamental statistical tests.

Response 12: The t-test and Wilcoxon signed ranks test were unsuitable for our study, as described in our response to comment 3.


Comment 13: Line 181: I cannot see the symbol between p-value and 0.05. Is it ≥ or ≤?

Response 13: The symbol ≤ has been clarified in line 197.


Comment 14: Line 271: Like my comment in Line 123-124, the pain improvement can be multi-factorial. This does not indicate clear improvement in pain scores following treatment.

Response 14: Please refer to our response 11.


Comment 15: Line 274: Like my comments in Line 129-130, the differences in the biomarkers are clinically trivial. They may not demonstrate significant differences.

Response 15: We respectfully disagree with the assertion that the differences in the biomarkers are clinically trivial and may not demonstrate significant differences.
1. Statistical Significance and Clinical Relevance: While the numerical differences in biomarkers may appear small, their statistical significance indicates that these changes are not due to random variation. In our study, we observed significant changes in median values for transferrin, CD4%, platelets, neutrophils, and transferrin saturation %, which suggests that these biomarkers are indeed responsive to antibiotic treatment in the context of TBIs.
2. Biomarker Importance: Even small changes in biomarkers can be clinically relevant, especially when considering the complexity of chronic diseases like TBIs. These biomarkers are involved in inflammatory and immune responses, critical in understanding the disease's pathophysiology and the patient's response to treatment.
3. Contextual Evidence: Our present findings align with :arrow: previous research (references 13 and 41) that has shown significant improvements in patient-reported symptoms, including pain, fatigue, and neurological symptoms, following antibiotic therapy. These improvements are correlated with the changes in biomarkers, reinforcing their clinical relevance.

To address this further, we have revised the manuscript to clarify the importance of these biomarker changes in the discussion section 3.1, lines 294 to 300.


Comment 16: Line 280-281: If you are saying these biomarkers are unreliable indicators of pain levels or the efficacy of pain management, then why are you choosing these as your biomarkers in the study?

Response 16: We determined that the word 'inadequate' is more appropriate for our sentence than 'unreliable' (line 305). This conclusion is based on the robust linear model results in Tables 2 and 3. Our analysis demonstrates that when the RLM model predicts pain changes using only the five biomarkers, transferrin and CD4% significantly affect pain ratings. However, when unmeasured factors are included, these five biomarkers do not influence pain ratings beyond the baseline change observed when all predictors are zero. This suggests that while these biomarkers may be essential for other clinical assessments or conditions, they are inadequate indicators of pain levels or the efficacy of pain management in this context.


Comment 17: Line 332-356: There are quite a lot of discussion on other pathogens, medical conditions and biomarkers not measured in the current study (e.g. UTI, TLR4, persistent low back pain, irritable bowel syndrome). I am not sure whether they are necessary. They seem to distract the readers from learning the main message of your study.

Response 17: We included discussions on other pathogens, medical conditions, and biomarkers not measured in our study to provide a comprehensive context for our findings. This broader perspective helps illustrate the complex and multifactorial nature of chronic pain and persistent symptoms in TBI patients, supporting our results and suggesting potential mechanisms and pathways that warrant further investigation. While these discussions may seem tangential, they reinforce the relevance of our findings within a broader medical framework and highlight the need for future research.


Comment 18: Line 392: Like my comments in Line 123 and 271, the current study did not seem to show strong evidence that antibiotic decreases pain.

Response 18: Please refer to our response 11.


Comment 19: Line 385-403: Although I appreciate the empathy towards patients, the current study did not demonstrate benefit of antibiotics and prolonged duration of antibiotics. A comparison trial would be needed to support the claim.

Response 19: Please refer to our response 11. Additionally, while we appreciate the need for rigorous comparative trials, our study provides significant evidence that supports the benefit of antibiotics in reducing pain and symptoms in TBI patients. The statistically significant reduction in pain scores following antibiotic treatment (median pain scores dropping from 7 to 5, U = 27215.50, p < 0.001) indicates a positive response to antibiotics. Additionally, prior studies on the same patient cohort (references 13 and 41) have shown similar symptom improvements with antibiotic therapy. These consistent findings across multiple studies underscore the potential benefits of antibiotic treatment, even without a direct comparison trial. We acknowledge the importance of further research, including comparison trials, to strengthen these conclusions, but the current evidence already suggests meaningful benefits..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 7911
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Di 30 Jul 2024, 17:41

Vervolg

:arrow: References 13 en 41 worden als bewijs gegeven?
Referentie 13: MDPI
Publicatie 24 augustus 2023
Open Access Article - 'A Longitudinal Study of a Large Clinical Cohort of Patients with Lyme Disease and Tick-Borne Co-Infections Treated with Combination Antibiotics' by David Xi, Abbie Thoma, Minha Rajput-Ray, Anne Madigan, Gordana Avramovic, Kunal Garg, Leona Gilbert, John S. Lambert; Bron https://doi.org/10.3390/microorganisms11092152

:arrow: Lees goed ook de volledige informatie(!) in het artikel; Bron viewtopic.php?f=5&t=2595&start=470#p30457
..2. Materials and Methods
..2.3. Serology Analysis
An ELISA platform was used to assess IgM and IgG antibody responses to Borrelia spp (B. afzelii and B. garinii), Borrelia persister forms, Babesia, Bartonella, Ehrlichia, and Rickettsia in this patient cohort using a modified two-tiered testing protocol. Serological testing was conducted using the TICKPLEX® test at ArminLabs GmbH in Augsburg, Germany. TICKPLEX® has the capability to assess IgM and IgG immune responses present in human serum samples against various species of Borrelia burgdorferi sensu lato in both spirochete and persistent forms, as well as against co-infections and opportunistic microbes. Specifically, TICKPLEX® encompasses Borrelia burgdorferi sensu stricto, Borrelia afzelii, and Borrelia garinii in their spirochete and persistent forms. It also covers other pathogens, like Babesia microti, Bartonella henselae, Ehrlichia chaffeensis, Rickettsia akari, Coxsackievirus, Epstein-Barr virus, Human parvovirus B19, Mycoplasma fermentans, and Mycoplasma pneumoniae [34]. The serological results were compiled and entered into an Excel spreadsheet for the handling of the data and analysis. We indicated if patients had positive, weakly positive, or negative antibody responses to the microorganisms. Using the serological data, we categorized patients into those with one TBI and those with multiple TBIs..
De :arrow: 301 patiënten zijn getest met de kostbare en niet-gevalideerde TickPlex Basic test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only; en de kostbare en niet-gevalideerde TickPlex Plus test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only van Tezted (Finland)? Met de testen kunnen géén diagnoses Lyme/chronische Lyme/neuroborreliose/Post-lymeziektesyndroomworden en of coinfecties worden gesteld en kunnen géén behandelingen worden gemonitord!!

Referentie 41: MDPI
Publicatie 12 februari 2024
Open Access Article - 'Scrutinizing Clinical Biomarkers in a Large Cohort of Patients with Lyme Disease and Other Tick-Borne Infections' by David Xi, Kunal Garg, John S. Lambert, Minha Rajput-Ray, Anne Madigan, Gordana Avramovic and Leona Gilbert; Bron https://www.mdpi.com/2076-2607/12/2/380

:arrow: Lees goed ook de volledige informatie(!) in het artikel; Bron viewtopic.php?f=5&t=2595&start=470#p30455
..2. Materials and Methods
..2.2. Serology Analysis
Serology analyses for these 110 patients were :arrow: performed by ArminLabs GmbH (Augsburg, Germany) using TICKPLEX®. ArminLabs GmbH is accredited by the German Accreditation Body DAkkS (International Accreditation No. DIN EN ISO 15189:2014) [46]. It is internationally accredited by CAP (College of American Pathologists) and verified by CLIA (Clinical Laboratory Improvement Amendments). TICKPLEX® is a :arrow: CE IVD (in vitro diagnostic) validated diagnostic test that can detect IgM and IgG antibodies against Borrelia burgdorferi sensu lato species, as well as their persistent forms :arrow: [47]. In addition, TICKPLEX® was used to detect antibodies against other known TBIs, such as Babesia microti, Bartonella henselae, Ehrlichia chaffeensis, and Rickettsia akari :arrow: [47].
For analyses, patients were indicated to have either “Positive” or “Negative” antibody responses to the tick-borne infections. Results from the serological testing were compiled into an Excel spreadsheet to handle the data and analysis (Supplementary Excel). Additionally, patients were categorized into these subgroups: Borrelia infections only, Borrelia and co-infections, Negative Serology, and Non-Borrelia Infections..
De 110 patiënten zijn getest met de kostbare en niet-gevalideerde TickPlex Basic test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only; en de kostbare en niet-gevalideerde TickPlex Plus test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only van Tezted (Finland)? Met de testen kunnen géén diagnoses Lyme/chronische Lyme/neuroborreliose/Post-lymeziektesyndroomworden en of coinfecties worden gesteld en kunnen géén behandelingen worden gemonitord!!
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 7911
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Di 30 Jul 2024, 18:13

Bron viewtopic.php?f=38&t=2435&start=220#p30465 ..Kunal Garg: We are encountering similar challenges when attempting to publish original research or case series on Lyme disease. Rejections are swift, often lacking detailed feedback that would help improve the work. It seems like we have to persevere and keep trying. All the best!..
Opmerkelijk is dat Garg van Tezted (Finland) bij het proberen hun zogenoemde onderzoek artikelen of case-studies gepubliceerd te krijgen niet begrijpt waar dat aan gelegen kan zijn..?

En met welk doel blijft Stichting Tekenbeetziekten de testen van de commerciële laboratoria Tezted (Finland) fabrikant! en ArminLabs (Duitsland) verkoper! promoten?

Opmerkelijk is dat de patiëntenorganisaties in Nederland Tezted (Finland) fabrikant! omarmen en zelfs plaats hebben laten nemen in een Wetenschappelijke adviescommissie. Van de kostbare en niet-gevalideerde IVD ('in-huis ontwikkelde test')/RUO Research Use Only testen van Tezted (Finland) wordt géén afstand genomen maar wordt indirect gepromoot in de Brochure Lymevereniging - ICLB & Patiëntensymposium 2022; Bron https://lymevereniging.nl/wp-content/up ... 221115.pdf en Bron viewtopic.php?f=5&t=2595&start=210#p29549
Bron viewtopic.php?f=5&t=2595&start=140#p29177 ..Stichting Lymefonds/het Lymefonds - Namens het Lymefonds heeft directeur Fred Verdult deelgenomen aan het patëntensymposium en aan ICLB, de internationale wetenschappelijke conferentie over lyme en andere tekenbeet-infecties. Op deze pagina’s deelt Fred enkele impressies: En ik sprak Leona Gilbert, directeur van het in lyme gespecialiseerde testbedrijf Tezted in Finland en de drijvende kracht achter het internationale samenwerkingsverband Lyme Global..
Stichting Tekenbeetziekten; Bron https://www.tekenbeetziekten.nl/over-ons/organisatie/ en Nieuwsbrief Jaargang 10 nummer 4, september 2022; Bron https://www.tekenbeetziekten.nl/over-ons/nieuwsbrieven/
..In het kader van onderzoek was dr. Leona Gilbert (CEO for Te?ted Oy and Docent in Cell and Molecular Biology) afgevaardigd door Stichting Tekenbeetziekten. Zij was aanwezig bij zowel het patiëntensymposium als het hoofdcongres..

..Wetenschappelijke adviescommissie
Leona Gilbert
Joop Klein Haneveld
Dominic Smith
Diana Uitdenbogerd-Drenth..
Hiermee wordt door de patiëntenorganisaties een verkeerd signaal afgegeven aan de (nieuwe) Lyme patiënten in Nederland! Dat geldt ook voor de 'Nederlandse vrienden van Tezted (Finland) (Testimonials from our friend associations and patients)' mei 2023; Bron https://www.tezted.com/lymeawarenessmonth en leden en vertegenwoordiger(s) van de Nederlandse patiëntenorganisaties; Bron viewtopic.php?f=5&t=2595&start=160#p29290


Verificatie leert:
Stichting Tekenbeetziekten over :arrow: RUO (Research Use Only) testen; Bron https://www.tekenbeetziekten.nl/de-teek ... boratoria/
..Soms beschikken laboratoria over RUO-tests (Research Use Only) die niet aan patiënten kunnen worden verkocht of voor diagnose kunnen worden gebruikt..
Daar zit nu juist het probleem!!. Verschillende genoemde commerciële laboratoria ( :arrow: onder andere Tezted (Finland)!!!) en sommige Ilads Lyme artsen, AVIG Lyme artsen, natuurartsen en therapeuten werken met dergelijke testen!
:arrow: De gevolgen voor de (geteste en te testen) patiënten zijn: een onjuiste testuitslag, een gemiste diagnose, een verkeerd gestelde diagnose, een verkeerde voorgeschreven behandeling, veroorzaakte (blijvende) schade aan de gezondheid.

:arrow: Waar moeten de (nieuwe) Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen goed op letten?

Products for “Research Use Only” (RUO); Bron https://www.johner-institute.com/articl ... ous-claim/
..:arrow: **Fabrikanten gebruiken het label 'Research Use Only' (RUO) om te verklaren dat hun producten niet mogen worden gebruikt in diagnostische procedures. Dit stelt hen in staat om de tijdrovende en dure documentatie te vermijden die vereist is voor conformiteitsbeoordeelde medische hulpmiddelen voor in-vitrodiagnostiek CE-IVD's). Niettemin gebruiken sommige medische laboratoria bijvoorbeeld nog steeds RUO-producten in diagnostische procedures soms zelfs met medeweten van de fabrikanten. Dit kan gevolgen hebben niet alleen voor fabrikanten en operators maar ook voor patiënten..

..**Patiënten missen de kennis om op zichzelf te herkennen wat wel en niet een RUO is. Ze krijgen vaak weinig tot geen informatie over de test die ze ondergaan. Patiënten dienen zich dus aan deze basisregel te houden: vraag ernaar bij uw arts of apotheker!
a) **Patiënten kunnen het volledige testrapport opvragen bij het laboratorium zodat ze bij twijfel een second opinion kunnen krijgen. Het rapport moet ook aangeven welke specifieke test is uitgevoerd.
b) **Patiënten moeten zichzelf informeren over hoe "goed" of "slecht" een test werkt evenals over de baten-risicoverhouding.
c) **In de toekomst zullen patiënten en artsen ook informatie over medische hulpmiddelen van EUDAMED kunnen krijgen en deze informatie kunnen gebruiken om te beslissen of de test al dan niet is uitgevoerd met gecertificeerde en dus wettelijk conforme IVD's..

..Naar de mening van de EU-commissie en de FDA horen producten 'uitsluitend voor onderzoeksdoeleinden' niet thuis in de diagnostiek. Om voor diagnostische doeleinden te worden gebruikt moeten producten de nodige controles ondergaan. Maar deze controles zijn niet van toepassing op RUO-producten.
Iedereen die dit verbod negeert en RUO-producten gebruikt of verkoopt voor andere doeleinden dan puur onderzoek speelt met vuur. Fabrikanten en operators lopen het risico op juridische problemen en kunnen zelfs de gezondheid van patiënten in gevaar brengen. Daarom mogen RUO-producten alleen voor onderzoeksdoeleinden worden gebruikt. Voor ander gebruik moeten fabrikanten en exploitanten de genoemde alternatieven gebruiken..

Een test kan pas betrouwbaar worden ingezet voor de medische diagnostiek als deze klinisch is gevalideerd.
De IVDR is op 26 mei 2022 in werking getreden en vanaf dat moment moeten alle fabrikanten van IVD hulpmiddelen zich aan de nieuwe regels houden; Bron https://www.diagnotix.com/nl/ivdr-validatie en Bron https://www.rijksoverheid.nl/onderwerpe ... abrikanten
..Validatie onder de IVDR
Door de invoering van de IVDR en de MDR wordt het toezicht op de productie van medische hulpmiddelen aangescherpt. Fabrikanten moeten door middel van een uitgebreidere validatie, wetenschappelijke onderbouwing én studies naar de klinische prestaties van hun producten aantonen dat hun product werkzaam en veilig is.

In de IVDR wordt uitgebreid beschreven welke validatiestappen benodigd zijn voor een CE-certificering en toelating tot de markt binnen de EU..

..De prestatie-evaluatie dient te bestaan uit de volgende onderdelen (art 58 lid 3 IVDR):
1. Wetenschappelijke Validiteit
2. Analytische Prestaties
3. Klinische Prestaties..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~


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