TY - JOUR
T1 - Corrigendum to “The effectiveness of manual-guided, problem-solving-based self-learning programme for family caregivers of people with recent-onset psychosis
T2 - A randomised controlled trial with 6-month follow-up” [International Journal of Nursing Studies 59 (2016) 141–155] (International Journal of Nursing Studies (2016) 59 (141–155), (S0020748916300104), (10.1016/j.ijnurstu.2016.03.018))
AU - Chien, Wai Tong
AU - Yip, Annie L.K.
AU - Liu, Justina Y.W.
AU - McMaster, Terry W.
N1 - Publisher Copyright:
© 2020 Elsevier Ltd
PY - 2021/1
Y1 - 2021/1
N2 - In the trial reported in Chien et al (2016) the authors state that they are reporting a single centre two-arm trial. Discrepancies between the published account and the protocol as described in the trial registry entry (https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02391649%amp;data=01%7C01%7Cian.j.norman%40kcl.ac.uk%7C13261bb51a2b47ee9e2808d850bd0b1e%7C8370cf1416f34c16b83c724071654356%7C0&sdata=ozX0jNwEaDzVt%2BfoRzQ6voIzC7QLYxH5%2BN4ZmeARFKs%3D&reserved=0) have been drawn to the journal editors' attention The authors acknowledge that there are misleading statements in the published paper. In fact the protocol referred to in the paper was for a different trial. The trial reported in Chien et al (2016) was preliminary work related to the trial described in the protocol but no protocol was registered for the trial described in this paper. The statement in the paper “While this controlled trial would have four post-tests over 24 months follow-up (refer to the clinical trial register of ClinicalTrials.gov, NCT02391649, at https://register.clinicaltrials.gov), this paper reported its results over the first 6 months post-intervention” is incorrect. As well as referring to a protocol that does not relate to the trial, the statement also implies that there is a longer follow up of the participants in the trial reported in Chien et al (2016) that is still to be reported. This is incorrect, as the longer follow up is a feature of the registered trial, not the trial reported in the paper. The authors would like to apologise for any inconvenience caused. EDITOR'S NOTE: As a trial conducted without a publicly available protocol published in advance readers are reminded that the results of the trial reported in Chien et al (2016) need to be interpreted with extreme caution as there is no way to ensure there is no selective outcome reporting in favour of results with statistically significant p-values (Won et al 2019). Because the International Journal of Nursing Studies did not require the prospective registration of clinical trials at the time the paper was submitted we judge that withdrawal of the paper is not warranted although we do consider the content of the paper to be seriously misleading. Prospective authors are reminded that the International Journal of Nursing Studies now adheres fully to the International Committee of Medical Journal Editors (ICMJE) policy of clinical trial registration. Any study that meets the definition of a clinical trial given by the IJMCE must be registered in a public trials registry at or before the time of first patient enrolment as a condition of consideration for publication. Retrospective registration of such trials is not acceptable.
AB - In the trial reported in Chien et al (2016) the authors state that they are reporting a single centre two-arm trial. Discrepancies between the published account and the protocol as described in the trial registry entry (https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02391649%amp;data=01%7C01%7Cian.j.norman%40kcl.ac.uk%7C13261bb51a2b47ee9e2808d850bd0b1e%7C8370cf1416f34c16b83c724071654356%7C0&sdata=ozX0jNwEaDzVt%2BfoRzQ6voIzC7QLYxH5%2BN4ZmeARFKs%3D&reserved=0) have been drawn to the journal editors' attention The authors acknowledge that there are misleading statements in the published paper. In fact the protocol referred to in the paper was for a different trial. The trial reported in Chien et al (2016) was preliminary work related to the trial described in the protocol but no protocol was registered for the trial described in this paper. The statement in the paper “While this controlled trial would have four post-tests over 24 months follow-up (refer to the clinical trial register of ClinicalTrials.gov, NCT02391649, at https://register.clinicaltrials.gov), this paper reported its results over the first 6 months post-intervention” is incorrect. As well as referring to a protocol that does not relate to the trial, the statement also implies that there is a longer follow up of the participants in the trial reported in Chien et al (2016) that is still to be reported. This is incorrect, as the longer follow up is a feature of the registered trial, not the trial reported in the paper. The authors would like to apologise for any inconvenience caused. EDITOR'S NOTE: As a trial conducted without a publicly available protocol published in advance readers are reminded that the results of the trial reported in Chien et al (2016) need to be interpreted with extreme caution as there is no way to ensure there is no selective outcome reporting in favour of results with statistically significant p-values (Won et al 2019). Because the International Journal of Nursing Studies did not require the prospective registration of clinical trials at the time the paper was submitted we judge that withdrawal of the paper is not warranted although we do consider the content of the paper to be seriously misleading. Prospective authors are reminded that the International Journal of Nursing Studies now adheres fully to the International Committee of Medical Journal Editors (ICMJE) policy of clinical trial registration. Any study that meets the definition of a clinical trial given by the IJMCE must be registered in a public trials registry at or before the time of first patient enrolment as a condition of consideration for publication. Retrospective registration of such trials is not acceptable.
UR - http://www.scopus.com/inward/record.url?scp=85095601252&partnerID=8YFLogxK
U2 - 10.1016/j.ijnurstu.2020.103794
DO - 10.1016/j.ijnurstu.2020.103794
M3 - Comment/debate/erratum
C2 - 33158501
AN - SCOPUS:85095601252
SN - 0020-7489
VL - 113
JO - International Journal of Nursing Studies
JF - International Journal of Nursing Studies
M1 - 103794
ER -