Parental experiences of the informed consent process in randomized clinical trials-A Nordic study

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Parental experiences of the informed consent process in randomized clinical trials-A Nordic study

Mogensen, Nina (författare): Karolinska Inst, Dept Womens & Childrens Hlth, Childhood Canc Res Unit, Stockholm, Sweden.;Karolinska Univ Hosp, Dept Pediat Oncol, Stockholm, Sweden.;Karolinska Inst, Dept Womens & Childrens Hlth, Childhood Canc Res Unit, Tomtebodavagen 18A, S-17177 Stockholm, Sweden.

Kreicbergs, Ulrika (författare): Karolinska Institutet,Karolinska Inst, Dept Womens & Childrens Hlth, Childhood Canc Res Unit, Stockholm, Sweden.;Ersta Sköndal Bräcke Univ Coll, Palliat Res Ctr, Dept Hlth Care Sci, Stockholm, Sweden.

Albertsen, Birgitte Klug (författare): Aarhus Univ Hosp, Dept Paediat & Adolescent Med, Aarhus, Denmark.;Univ Aarhus, Inst Clin Med, Fac Hlth, Aarhus, Denmark.

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Lahteenmäki, Päivi (författare): Karolinska Institutet,Fican West & Turku Univ, Turku Univ Hosp, Pediat & Adolescent Hematol Oncol, Turku, Finland.;Karolinska Inst, Swedish Childhood Canc Registry, Stockholm, Sweden.

Heyman, Mats (författare): Karolinska Institutet,Karolinska Inst, Dept Womens & Childrens Hlth, Childhood Canc Res Unit, Stockholm, Sweden.;Karolinska Univ Hosp, Dept Pediat Oncol, Stockholm, Sweden.

Harila, Arja (författare): Uppsala universitet,Barnonkologisk och neurologisk forskning,Pediatric Oncology, Uppsala University Hospital, Uppsala, Sweden

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Karolinska Institutet Karolinska Inst, Dept Womens & Childrens Hlth, Childhood Canc Res Unit, Stockholm, Sweden;Karolinska Univ Hosp, Dept Pediat Oncol, Stockholm, Sweden.;Karolinska Inst, Dept Womens & Childrens Hlth, Childhood Canc Res Unit, Tomtebodavagen 18A, S-17177 Stockholm, Sweden. (creator_code:org_t)

John Wiley & Sons, 2023
2023
Engelska.
Ingår i: Pediatric Blood & Cancer. - : John Wiley & Sons. - 1545-5009 .- 1545-5017. ; 70:12

Relaterad länk:: https://doi.org/10.1...; visa fler...; https://uu.diva-port... (primary) (Raw object); https://urn.kb.se/re...; https://doi.org/10.1...; http://kipublication...; visa färre...

Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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BackgroundRandomized clinical trials (RCTs) are an essential part of improving acute lymphoblastic leukemia (ALL) treatment. This population-based questionnaire study investigated parents' experiences of the informed consent process in the RCTs within the Nordic NOPHO (Nordic Society of Paediatric Haematology and Oncology) ALL2008 trial.ProcedureParents in Sweden, Denmark, and Finland whose child was alive and in first remission after end of therapy and who were asked to participate in any RCT in the ALL2008 protocol, were asked to complete 15 questions/items regarding their experience of the RCT consent process.ResultsA total of 483 parents of 279 children met the inclusion criteria and answered the study questionnaire. Most (91%) agreed/strongly agreed to having received sufficient information to make a well-informed decision, felt confidence in the study design (86%), and thought that the process was satisfactory (86%). Those who did not consent reported a generally more negative experience of the process. More than a third of all parents and over half of parents who had refused participation felt that it was burdensome to decide. Most parents (66%) in general, and one-third of those with children 8 years or older, reported that their child was not involved in the process.ConclusionsParents were in general satisfied with the informed consent process, although many parents, particularly those who refused participation, reported it as burdensome to make the decision concerning RCT. Fewer than expected of the school-aged children were involved in the decision process, which calls for attention on how children are included in the consent procedure in clinical trials.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Pediatrik (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Pediatrics (hsv//eng)

Nyckelord

acute lymphoblastic leukemia
childhood cancer
clinical trials
informed consent

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Av författaren/redakt...: Mogensen, Nina; Kreicbergs, Ulri ...; Albertsen, Birgi ...; Lahteenmäki, Päi ...; Heyman, Mats; Harila, Arja

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Cancer och onkol ...

MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Pediatrik

Artiklar i publikationen: Pediatric Blood ...

Av lärosätet: Uppsala universitet; Karolinska Institutet

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