roll-in subjects

German translation: im Zuge der Studie behandelte Personen

16:32 Sep 17, 2018

English to German translations [PRO]
Medical - Medical: Health Care / Klinische Studie

English term or phrase: roll-in subjects

Es geht um eine Untersuchung von neuen Bypass-Systemen. Im Text heißt es:

"STUDY DESIGN: Prospective, single-arm, multi-center, international, non- randomized, pre-market, safety and effectiveness clinical investigation
PLANNED ENROLMENT: Enrolment of up to xxx evaluable subjects and up to yy ***roll-in subjects***"

Xxx und yy stehen für Zahlen.

Wenn ich hier "subjects" mit Probanden übersetze: Was in aller Welt sind dann "roll-in subjects"?

VDiV

Wolfgang Hummel KudoZ activity Questions: 503 (1 open) (1 without valid answers) (12 closed without grading) Answers: 333 Spain
Local time: 23:53

German translation:im Zuge der Studie behandelte Personen

Explanation:
rekrutierte / behandelte Testpersonen / Patienten

Selected response from:

Regina Eichstaedter
Local time: 23:53

Grading comment

Danke, Regina!
4 KudoZ points were awarded for this answer

Summary of answers provided

3 +2

im Zuge der Studie behandelte Personen

Regina Eichstaedter

Vorstudien-Probanden (Vorstudien-Teilnehmer)

Johannes Gleim

"aufzunehmende" oder "teilnehmende" Probanden

Harald Koop

erst zu behandelnde Patienten

Stuart and Aida Nelson

Summary of reference entries provided

roll-in subjects

Marga Shaw

Discussion entries: 4

Answers

15 mins confidence:

peer agreement (net): +2

im Zuge der Studie behandelte Personen

Explanation:
rekrutierte / behandelte Testpersonen / Patienten

Reference: http://www.proz.com/kudoz/english/medical-general/6206765-ro...

Regina Eichstaedter
Local time: 23:53
Works in field
Native speaker of:

German
PRO pts in category: 40

Grading comment

Danke, Regina!

17 mins confidence:

"aufzunehmende" oder "teilnehmende" Probanden

Explanation:
Wahrscheinlich kommt das von "Enrollment", also "Aufnahme" oder "Teilnahme". Ich habe schon viele klinische Studien übersetzt - aber der Begriff ist mir so noch nicht untergekommen. Ich würde es aber wie oben beschrieben übersetzen.

Harald Koop
Germany
Local time: 23:53
Specializes in field
Native speaker of:

German

56 mins confidence:

erst zu behandelnde Patienten

Explanation:
Die erste Patienten' mit 'Bypass-Systemen' in diesem Kontext vielleicht.

Die erste Patienten, bei denen ein Arzt ein Bypass verwendet

INCLUSION OF ROLL-IN PATIENTS IN PRE-FDA APPROVAL CARDIOVASCULAR DEVICE TRIALS
Roll-in patients are the first individuals in whom a physician uses an investigational medical device.
http://www.onlinejacc.org/content/accj/55/10_Supplement/A133...

Normalerweise: nicht-randomisierte Patienten aber die klinische Studie ist schon nicht-randomisiert.

Stuart and Aida Nelson
United Kingdom
Local time: 22:53
Specializes in field
Native speaker of:

English,

Spanish
PRO pts in category: 8

22 hrs confidence:

Vorstudien-Probanden (Vorstudien-Teilnehmer)

Explanation:
Some definitions from the already quoted

METHODS:
The first two subjects at each participating site (n = 20) were roll-in cases (ie, not randomized but instead treated with CAC) to ensure the physician's familiarity with the procedure. Subsequent eligible subjects were randomized to either CAC or RFA. After treatment, all subjects returned for assessment on day 3 and months 1, 3, 6, and 12. The study's primary end point was complete closure of the target vein at month 3. Secondary analyses included patient-reported intraprocedural pain and investigator-rated ecchymosis at day 3. Additional assessments included procedure time, quality of life surveys, and adverse events.
RESULTS:
Mean procedure time was longer in the roll-in group (31 minutes) compared with the randomized groups (24 minutes for CAC and 19 minutes for RFA; P < .0001). Procedure time decreased in both the CAC and RFA groups over time, plateauing at about 22 minutes for CAC and 15 minutes for RFA. In the roll-in group, the 3-month complete occlusion rate was 100%
https://www.ncbi.nlm.nih.gov/pubmed/27638993

They use the term "roll-in" when some new devices are to be tested and the investigators should have possibility to train themselves first. It means that these 3 subjects were the patients treated during the training period, prior to randomization.
https://forum.wordreference.com/threads/roll-in.1941094/

Given the definition from the reference comment of "a small number of subjects per site that will not be included in the endpoint evaluation (sometimes termed “roll-in” subjects)" we can use the definition instead of translating the asked term "excepted from the study"

My approach:

STUDIENPLAN: Vorausschauende, multizentrische, internationale, nicht-randomisierte klinische Untersuchung einer einheitliche Gruppe vor Markteinführung zur Sicherheit und Wirksamkeit
GEPLANTE REGISTRIERUNG: Registrierung von bis zu xxx zu untersuchende Probanden und bis zu yy *** Vorstudien-Probanden.

10.3 Probandeninformation für Vorstudien-Probanden
https://www.google.de/url?sa=t&rct=j&q=&esrc=s&source=web&cd...

4.2.1 Vorstudien
Für die vorliegende Arbeit wurden Patienten mit unilateral spastischer CP mit ausschließlich linkshemisphärisch er Läsion in den Modalitäten Sprachprodukt i- on und Sprachverstehen untersucht und die Ergebnisse mit gesunden Kontrollperson en verglichen.
http://docplayer.org/58921510-Inaugural-dissertation-zur-erl...

Found also "Vorstudien-Teilnehmer"

Johannes Gleim
Local time: 23:53
Works in field
Native speaker of: German
PRO pts in category: 35

Reference comments

1 hr peer agreement (net): +2

Reference: roll-in subjects

Reference information:
Definition:

If an investigator or other site staff lack a thorough knowledge of the clinical procedures used in your study, we recommend that you provide training on the procedures. It may be appropriate to include a small number of subjects per site that will not be included in the endpoint evaluation (sometimes termed “roll-in” subjects) in order to avoid a learning curve bias. The inclusion of a subject as a “roll-in” subject should be specified prior to treating the subject and prior to subject randomization (if applicable).
https://www.fda.gov/MedicalDevices/ucm182016.htm

Marga Shaw
United Kingdom
Works in field
Native speaker of: German
PRO pts in category: 80

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roll-in subjects

German translation: im Zuge der Studie behandelte Personen

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